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HomeMy WebLinkAboutAgreement A-18-701 with DNA Diagnostic Center.pdf1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Agreement No . 18 -701 AGREEMENT THIS AGREEMENT is made and entered into this 11th day of December, 2018 , by and between the COUNTY OF FRESNO , a Political Subdivision of the State of California , hereinafter referred to as "COUNTY", and DNA DIAGNOSTICS CENTER , INC., an Ohio corporation , whose address is One DOC Way, Fairfield , OH 45014, hereinafter referred to as "CONTRACTOR". W I T N E S S E T H : WHEREAS , COUNTY's Department of Child Support Services is required to provide a program for the enforcement of support and determination of paternity pursuant to the Uniform Act of Blood Tests to Determining Paternity; WHEREAS, COUNTY's Department of Social Services has a need for a minimal amount of paternity testing services for program purposes ; and WHEREAS , the COUNTY issued Request for Quotation (RFQ) No . 18-085 and Addendums Nos. 1 One (1) and Two (2) for DNA and patern ity testing services and CONTRACTOR was the successful bidder ; NOW, THEREFORE , in consideration of the mutual covenants , terms and cond itions herein contained, the parties hereto agree as follows : 1 . OBLIGATIONS OF THE CONTRACTOR A. CONTRACTOR shall perform for each case DNA testing following the most current standards of the AABB (formerly the American Association of Blood Banks), in accordance with the RFQ. These tests shall provide exclusions at multiple loci or if not excluded, a cumulative paternity index of at least 100 (probably of paternity > 99% with a 0 .5 prior probability). B . CONTRACTOR shall provide to COUNTY written reports and interpretation of test results , including the probability of paternity and the prior probability factor used in calculating the result , in accordance with the RFQ . C. CONTRACTOR shall testify at depositions and/or trials , if required by COUNTY . D . CONTRACTOR shall provide COUNTY staff with unlimited telephone access and face-to-face consultations from 0800 to 1700 PST each working day, excluding holidays. -1- -2- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 E. CONTRACTOR shall provide all supplies necessary for the collection and preservation of specimens along with photographic and thumb print chain of custody documentation. F. CONTRACTOR shall ensure parental or guardian consent is received prior to testing in cases involving minor mothers or alleged minor fathers. G. CONTRACTOR shall retain specimen collections for a minimum of seven (7) years or longer if specifically requested by COUNTY. H. CONTRACTOR will provide phlebotomy/specimen collection services using CONTRACTOR’s employees based in Fresno, California. Specimens are to be drawn every Tuesday from 0800 to 1700 PST and every other Thursday from 0800 to 1130 PST in the blood draw room located adjacent to Department 301 of the B.F. Sisk Courthouse, Fresno County Superior Court, as well as on other days or at other locations deemed necessary by COUNTY. Specimens will be transported or shipped by CONTRACTOR to CONTRACTOR’s testing facilities the same day. CONTRACTOR will test from buccal swab specimens, and post mortem specimens at the COUNTY’s request. In the case of post mortem specimens, CONTRACTOR shall respond to COUNTY’s request for collection of a sample within twenty-four (24) hours. In no event shall specimens be drawn at any Fresno County jail facility, COUNTY’s office building located at 2135 Fresno Street in Fresno, California, or at the Fresno County Superior Court’s criminal division located at 1100 Van Ness Avenue in Fresno, California. I. CONTRACTOR will remove all hazardous waste at the conclusion of drawing specimens and dispose of it by methods that are in full compliance with all applicable regulations and laws. J. CONTRACTOR’s maximum turnaround time may not exceed four weeks from drawing to issuance of report. K. CONTRACTOR shall submit to COUNTY’s Department of Child Support Services and Department of Social Services a monthly statement listing the names of the persons tested and the tests and services performed for each person. L. Subject to Section 10 “CONFIDENTIALITY” of this Agreement, the use or disclosure of information concerning persons tested shall be strictly limited to COUNTY and its agents or other persons designated by COUNTY, persons possessing a valid subpoena requiring disclosure, -3- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 courts, law enforcement officials and other public officials for purposes directly connected with the administration of the State Statutory Plan (Welfare and Institutions Code § 10850) for establishing paternity and enforcing child support, including identifying and locating putative or deserting parents; establishing paternity; enforcing support obligations; investigating welfare fraud; and any investigation, prosecution or criminal or civil proceeding, conducted in connection with the administration of the State Plan. No information shall be disclosed to any legislative body or committee thereof which identifies any person tested or recipient of public assistance by name or address. M. CONTRACTOR shall maintain an organizational structure and sufficient staff to administer and supervise all of the functions for which they are responsible for as described in the RFQ. 2. TERM The term of this Agreement shall be for a period of three (3) years, commencing on January 1st, 2019 through and including December 31st, 2021. This Agreement may be extended for two (2) additional consecutive twelve (12) month periods upon written approval of both parties no later than thirty (30) days prior to the first day of the next twelve (12) month extension period. The Director of the Department of Child Support Services or his or her designee is authorized to execute such written approval on behalf of COUNTY based on CONTRACTOR’S satisfactory performance. 3. TERMINATION A. Non-Allocation of Funds - The terms of this Agreement, and the services to be provided hereunder, are contingent on the approval of funds by the appropriating government agency. Should sufficient funds not be allocated, the services provided may be modified, or this Agreement terminated, at any time by giving the CONTRACTOR thirty (30) days advance written notice. B. Breach of Contract - The COUNTY may immediately suspend or terminate this Agreement in whole or in part, where in the determination of the COUNTY there is: 1) An illegal or improper use of funds; 2) A failure to comply with any term of this Agreement; 3) A substantially incorrect or incomplete report submitted to the COUNTY; 4) Improperly performed service. -4- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 In no event shall any payment by the COUNTY constitute a waiver by the COUNTY of any breach of this Agreement or any default which may then exist on the part of the CONTRACTOR. Neither shall such payment impair or prejudice any remedy available to the COUNTY with respect to the breach or default. The COUNTY shall have the right to demand of the CONTRACTOR the repayment to the COUNTY of any funds disbursed to the CONTRACTOR under this Agreement, which in the judgment of the COUNTY were not expended in accordance with the terms of this Agreement. The CONTRACTOR shall promptly refund any such funds upon demand. C. Without Cause - Under circumstances other than those set forth above, this Agreement may be terminated by COUNTY upon the giving of thirty (30) days advance written notice of an intention to terminate to CONTRACTOR. 4. COMPENSATION/INVOICING: COUNTY agrees to pay CONTRACTOR and CONTRACTOR agrees to receive compensation as follows: DNA Testing with buccal swabs $31.25 per person DNA Testing with blood samples $31.25 per person Additional testing required to reach a paternity index of 100 $0 per person Consultation with other laboratories to confirm unusual or uncertain results $0 per person Drawing and identification fee (Fresno County Area) $0 per person Drawing and identification fee (outside Fresno County Area) $0 per person Expert Witness Fee (Court or deposition time) $0 per person Retesting requested by laboratory $0 per person CONTRACTOR shall submit monthly invoices to the County of Fresno Department of Child Support Services, P.O. Box 12946, Fresno, CA 93779-2946, or Department of Social Services, 2135 Fresno Street, Suite 100, Fresno, CA 93721, as applicable. In no event shall services performed under this Agreement be in excess of Three Hundred Thousand Dollars and No/100s ($300,000.00) during the term of this Agreement, including the two (2) one- year renewal periods. It is understood that all expenses incidental to CONTRACTOR'S performance of services under this Agreement shall be borne by CONTRACTOR. COUNTY will pay CONTRACTOR after a minimum of forty-five (45) days from date of receipt of invoice by the COUNTY. -5- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 5. INDEPENDENT CONTRACTOR: In performance of the work, duties and obligations assumed by CONTRACTOR under this Agreement, it is mutually understood and agreed that CONTRACTOR, including any and all of the CONTRACTOR'S officers, agents, and employees will at all times be acting and performing as an independent contractor, and shall act in an independent capacity and not as an officer, agent, servant, employee, joint venturer, partner, or associate of the COUNTY. Furthermore, COUNTY shall have no right to control or supervise or direct the manner or method by which CONTRACTOR shall perform its work and function. However, COUNTY shall retain the right to administer this Agreement so as to verify that CONTRACTOR is performing its obligations in accordance with the terms and conditions thereof. CONTRACTOR and COUNTY shall comply with all applicable provisions of law and the rules and regulations, if any, of governmental authorities having jurisdiction over matters the subject thereof. Because of its status as an independent contractor, CONTRACTOR shall have absolutely no right to employment rights and benefits available to COUNTY employees. CONTRACTOR shall be solely liable and responsible for providing to, or on behalf of, its employees all legally-required employee benefits. In addition, CONTRACTOR shall be solely responsible and save COUNTY harmless from all matters relating to payment of CONTRACTOR'S employees, including compliance with Social Security withholding and all other regulations governing such matters. It is acknowledged that during the term of this Agreement, CONTRACTOR may be providing services to others unrelated to the COUNTY or to this Agreement. 6. MODIFICATION: Any matters of this Agreement may be modified from time to time by the written consent of all the parties without, in any way, affecting the remainder. 7. NON-ASSIGNMENT: Neither party shall assign, transfer or sub-contract this Agreement nor their rights or duties under this Agreement without the prior written consent of the other party. 8. HOLD HARMLESS: CONTRACTOR agrees to indemnify, save, hold harmless, and at COUNTY'S request, defend the COUNTY, its officers, agents, and employees from any and all costs and expenses (including attorney’s fees and costs), damages, liabilities, claims, and losses occurring or resulting to COUNTY in connection with the performance, or failure to perform, by CONTRACTOR, its officers, agents, or employees under this Agreement, and from any and all costs and expenses (including attorney’s fees and costs), damages, liabilities, claims, and losses occurring or resulting to any person, firm, -6- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 or corporation who may be injured or damaged by the performance, or failure to perform, of CONTRACTOR, its officers, agents, or employees under this Agreement. 9. INSURANCE Without limiting the COUNTY's right to obtain indemnification from CONTRACTOR or any third parties, CONTRACTOR, at its sole expense, shall maintain in full force and effect, the following insurance policies or a program of self-insurance, including but not limited to, an insurance pooling arrangement or Joint Powers Agreement (JPA) throughout the term of the Agreement: A. Commercial General Liability Commercial General Liability Insurance with limits of not less than Two Million Dollars ($2,000,000.00) per occurrence and an annual aggregate of Four Million Dollars ($4,000,000.00). This policy shall be issued on a per occurrence basis. COUNTY may require specific coverages including completed operations, products liability, contractual liability, Explosion-Collapse-Underground, fire legal liability or any other liability insurance deemed necessary because of the nature of this contract. B. Automobile Liability Comprehensive Automobile Liability Insurance with limits of not less than One Million Dollars ($1,000,000.00) per accident for bodily injury and for property damages. Coverage should include any auto used in connection with this Agreement. C. Professional Liability If CONTRACTOR employs licensed professional staff, (e.g., Ph.D., R.N., L.C.S.W., M.F.C.C.) in providing services, Professional Liability Insurance with limits of not less than One Million Dollars ($1,000,000.00) per occurrence, Three Million Dollars ($3,000,000.00) annual aggregate. D. Worker's Compensation A policy of Worker's Compensation insurance as may be required by the California Labor Code. E. Technology Professional Liability (Errors and Omissions) Technology Professional Liability (Errors and Omissions) Insurance appropriate to the CONTRACTOR’s profession, with limits not less than $2,000,000 per occurrence or claim, $2,000,000 aggregate. Coverage shall be sufficiently broad to respond to the duties and obligations as is undertaken -7- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 by CONTRACTOR in this agreement and shall include, but not be limited to, claims involving infringement of intellectual property, including but not limited to infringement of copyright, trademark, trade dress, invasion of privacy violations, information theft, damage to or destruction of electronic information, release of private information, alteration of electronic information, extortion and network security. The policy shall provide coverage for breach response costs as well as regulatory fines and penalties as well as credit monitoring expenses with limits sufficient to respond to these obligations. F. Cyber Liability Cyber Liability Insurance, with limits not less than $2,000,000 per occurrence or claim, $2,000,000 aggregate. Coverage shall be sufficiently broad to respond to the duties and obligations as is undertaken by CONTRACTOR in this agreement and shall include, but not be limited to, claims involving infringement of intellectual property, including but not limited to infringement of copyright, trademark, trade dress, invasion of privacy violations, information theft, damage to or destruction of electronic information, release of private information, alteration of electronic information, extortion and network security. The policy shall provide coverage for breach response costs as well as regulatory fines and penalties as well as credit monitoring expenses with limits sufficient to respond to these obligations. Additional Requirements Relating to Insurance CONTRACTOR shall obtain endorsements to the Commercial General Liability insurance naming the County of Fresno, its officers, agents, and employees, individually and collectively, as additional insured, but only insofar as the operations under this Agreement are concerned. Such coverage for additional insured shall apply as primary insurance and any other insurance, or self-insurance, maintained by COUNTY, its officers, agents and employees shall be excess only and not contributing with insurance provided under CONTRACTOR's policies herein. This insurance shall not be cancelled or changed without a minimum of thirty (30) days advance written notice given to COUNTY. CONTRACTOR hereby waives its right to recover from COUNTY, its officers, agents, and employees any amounts paid by the policy of worker’s compensation insurance required by this Agreement. CONTRACTOR is solely responsible to obtain any endorsement to such policy that may be necessary to accomplish such waiver of subrogation, but CONTRACTOR’s waiver of subrogation under this paragraph is effective whether or not CONTRACTOR obtains such an endorsement. -8- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Within Thirty (30) days from the date CONTRACTOR signs and executes this Agreement, CONTRACTOR shall provide certificates of insurance and endorsement as stated above for all of the foregoing policies, as required herein, to the County of Fresno, (Name and Address of the official who will administer this contract), stating that such insurance coverage have been obtained and are in full force; that the County of Fresno, its officers, agents and employees will not be responsible for any premiums on the policies; that such Commercial General Liability insurance names the County of Fresno, its officers, agents and employees, individually and collectively, as additional insured, but only insofar as the operations under this Agreement are concerned; that such coverage for additional insured shall apply as primary insurance and any other insurance, or self-insurance, maintained by COUNTY, its officers, agents and employees, shall be excess only and not contributing with insurance provided under CONTRACTOR's policies herein; and that this insurance shall not be cancelled or changed without a minimum of thirty (30) days advance, written notice given to COUNTY. In the event CONTRACTOR fails to keep in effect at all times insurance coverage as herein provided, the COUNTY may, in addition to other remedies it may have, suspend or terminate this Agreement upon the occurrence of such event. All policies shall be issued by admitted insurers licensed to do business in the State of California, and such insurance shall be purchased from companies possessing a current A.M. Best, Inc. rating of A FSC VII or better. 10. CONFIDENTIALITY A. The parties of this Agreement shall be in strict conformance with all applicable Federal and State of California laws and regulations, including but not limited to Sections 5328, 10850, and 14100.2 et seq. of the Welfare and Institutions Code, Sections 2.1 and 431.300 et seq. of Title 42, Code of Federal Regulations (CFR), Section 56 et seq. of the California Civil Code, Sections 11977 and 11812 of Title 22 of the California Code of Regulations, and the Health Insurance Portability and Accountability Act (HIPAA), including but not limited to Section 1320 D et seq. of Title 42, United States Code (USC) and its implementing regulations, including, but not limited to Title 45, CFR, Sections 142, 160, 162, and 164. The Health Information Technology for Economic and Clinical Health Act (HITECH) regarding the confidentiality and security of patient information, and the Genetic Information Nondiscrimination Act (GINA) of 2008 -9- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 regarding the confidentiality of genetic information. Except as otherwise provided in this Agreement, CONTRACTOR, as a Business Associate of COUNTY, may use or disclose Protected Health Information (PHI) to perform functions, activities or services for or on behalf of COUNTY, as specified in this Agreement, provided that such use or disclosure shall not violate the Health Insurance Portability and Accountability Act (HIPAA), USC 1320d et seq. The uses and disclosures of PHI may not be more expansive than those applicable to COUNTY, as the “Covered Entity” under the HIPAA Privacy Rule (45 CFR 164.500 et seq.), except as authorized for management, administrative or legal responsibilities of the Business Associate. B. CONTRACTOR, including its subcontractors and employees, shall protect, from unauthorized access, use, or disclosure of names and other identifying information, including genetic information, concerning persons receiving services pursuant to this Agreement, except where permitted in order to carry out data aggregation purposes for health care operations [45 CFR Sections 164.504 (e)(2)(i), 164.504 (3)(2)(ii)(A), and 164.504 (e)(4)(i)]. This pertains to any and all persons receiving services pursuant to a COUNTY funded program. This requirement applies to electronic PHI. CONTRACTOR shall not use such identifying information or genetic information for any purpose other than carrying out CONTRACTOR’s obligations under this Agreement. C. CONTRACTOR, including its subcontractors and employees, shall not disclose any such identifying information or genetic information to any person or entity, except as otherwise specifically permitted by this Agreement, authorized by Subpart E of 45 CFR Part 164 or other law, required by the Secretary, or authorized by the client/patient in writing. In using or disclosing PHI that is permitted by this Agreement or authorized by law, CONTRACTOR shall make reasonable efforts to limit PHI to the minimum necessary to accomplish intended purpose of use, disclosure or request. D. For purpose of the above sections, identifying information shall include, but not be limited to name, identifying number, symbol, or other identifying particular assigned to the individual, such as finger or voice print, or photograph. E. For purposes of the above sections, genetic information shall include genetic tests of family members of an individual, manifestation of disease or disorder of family members of an individual, or any request for or receipt of, genetic services by individual or family members. Family member means a -10- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 dependent or any person who is first, second, third, or fourth degree relative. F. CONTRACTOR shall provide access, at the request of COUNTY, and in the time and manner designated by COUNTY, to PHI in a designated record set (as defined in 45 CFR Section 164.501), to an individual or to COUNTY in order to meet the requirements of 45 CFR Section 164.524 regarding access by individuals to their PHI. With respect to individual requests, access shall be provided within thirty (30) days from request. Access may be extended if CONTRACTOR cannot provide access and provides individual with the reasons for the delay and the date when access may be granted. PHI shall be provided in the form and format requested by the individual or COUNTY. CONTRACTOR shall make any amendment(s) to PHI in a designated record set at the request of COUNTY or individual, and in the time and manner designated by COUNTY in accordance with 45 CFR Section 164.526. CONTRACTOR shall provide to COUNTY or to an individual, in a time and manner designated by COUNTY, information collected in accordance with 45 CFR Section 164.528, to permit COUNTY to respond to a request by the individual for an accounting of disclosures of PHI in accordance with 45 CFR Section 164.528. CONTRACTOR shall report to COUNTY, in writing, any knowledge or reasonable belief that there has been unauthorized access, viewing, use, disclosure, security incident, or breach of unsecure PHI not permitted by this Agreement of which it becomes aware, immediately and without reasonable delay and in no case later than two (2) business days of discovery. Immediate notification shall be made to COUNTY’s Information Security Officer and Privacy Officer and COUNTY’s DPH HIPAA Representative, within two (2) business days of discovery. The notification shall include, to the extent possible, the identification of each individual whose unsecured PHI has been, or is reasonably believed to have been, accessed, acquired, used, disclosed, or breached. CONTRACTOR shall take prompt corrective action to cure any deficiencies and any action pertaining to such unauthorized disclosure required by applicable Federal and State Laws and regulations. CONTRACTOR shall investigate such breach and is responsible for all notifications required by law and regulation or deemed necessary by COUNTY and shall provide a written report of the investigation and reporting required to COUNTY’s Information Security Officer and Privacy Officer and COUNTY’s DPH HIPAA Representative. This written investigation and description of -11- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 any reporting necessary shall be postmarked within the thirty (30) working days of the discovery of the breach to the addresses below: County of Fresno County of Fresno County of Fresno Dept. of Public Health Dept. of Public Health Internal Services Dept. HIPAA Representative Privacy Officer Information Security Officer (559) 600-3200 (559) 600-3200 (559) 600-5800 P.O. Box 11867 P.O. Box 11867 333 W. Pontiac Way Fresno, CA 93775 Fresno, CA 93775 Clovis, CA 93612 H. CONTRACTOR shall make its internal practices, books, and records relating to the use and disclosure of PHI received from COUNTY, or created or received by the CONTRACTOR on behalf of COUNTY, in compliance with HIPAA’s Privacy Rule, including, but not limited to the requirements set forth in Title 45, CRF, Sections 160 and 164. CONTRACTOR shall make its internal practices, books, and records relating to the use and disclosure of PHI received from COUNTY, or crated or received by the CONTRACTOR on behalf of COUNTY, available to the United State Department of Health and Human Services (Secretary) upon demand. CONTRACTOR shall cooperate with the compliance and investigation reviews conducted by the Secretary. PHI access to the Secretary must be provided during the CONTRACTOR’s normal business hours, however, upon exigent circumstances access at any time must be granted. Upon the Secretary’s compliance or investigation review, if PHI is unavailable to CONTRACTOR and in possession of a Subcontractor, it must certify efforts to obtain the information to the Secretary. I. Safeguards CONTRACTOR shall implement administrative, physical, and technical safeguards as required by the HIPAA Security Rule, Subpart C of 45 CFR 164, that reasonably and appropriately protect the confidentiality, integrity, and availability of PHI, including electronic PHI, that it creates, receives, maintains or transmits on behalf of COUNTY and to prevent unauthorized access, viewing, use, disclosure, or breach of PHI other than as provided for by this Agreement. CONTRACTOR shall conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidential, integrity and availability of electronic PHI. CONTRACTOR shall develop and maintain a written information privacy and security program that includes administrative, technical and physical safeguards appropriate to the size and complexity of CONTRACTOR’s operations and the nature and scope of its activities. Upon COUNTY’s -12- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 request, CONTRACTOR shall provide COUNTY with information concerning such safeguards. CONTRACTOR shall implement strong access controls and other security safeguards and precautions in order to restrict logical and physical access to confidential, personal (e.g., PHI) or sensitive data to authorized users only. Said safeguards and precautions shall include the following administrative and technical password controls for all systems used to process or store confidential, personal, or sensitive data. 1. Passwords must not be: a. Shared or written down where they are accessible or recognizable by anyone else; such as taped to computer screens, stored under keyboards, or visible in a work area; b. A dictionary word; or c. Stored in clear text 2. Passwords must be: a. Eight (8) characters or more in length; b. Changed every ninety (90) days; c. Changed immediately if revealed or compromised; and d. Composed of characters from at least three (3) of the following four (4) groups from the standard keyboard: 1) Upper case letters (A-Z); 2) Lowercase letters (a-z); 3) Arabic numerals (0 through 9); and 4) Non-alphanumeric characters (punctuation symbols). CONTRACTOR shall implement the following security controls on each workstation or portable computing device (e.g., laptop computer) containing confidential, personal, or sensitive data: 1. Network-based firewall and/or personal firewall; 2. Continuously updated anti-virus software; and 3. Patch management process including installation of all operating system/software vendor security patches. CONTRACTOR shall utilize a commercial encryption solution that has received FIPS 140-2 -13- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 validation to encrypt all confidential, personal, or sensitive data stored on portable electronic media (including, but not limited to, compact disks and thumb drives) and on portable computing devices (including, but not limited to, laptop and notebook computers). CONTRACTOR shall not transmit confidential, personal, or sensitive data via e-mail or other internet transport protocol unless the data is encrypted by a solution that has been validated by the National Institute of Standards and Technology (NIST) as conforming to the Advanced Encryption Standard (AES) Algorithm. CONTRACTOR must apply appropriate sanctions against its employees who fail to comply with these safeguards. CONTRACTOR must adopt procedures for terminating access to PHI when employment of employee ends. J. Mitigation of Harmful Effects CONTRACTOR shall mitigate, to the extent practicable, any harmful effect that is suspected or known to CONTRACTOR of an unauthorized access, viewing, use, disclosure, or breach of PHI by CONTRACTOR or its subcontractors in violation of the requirements of these provisions. CONTRACTOR must document suspected or known harmful effects and the outcome. K. CONTRACTOR’s Subcontractors CONTRACTOR shall ensure that any of its contractors, including subcontractors, if applicable, to whom CONTRACTOR provides PHI received from or created or received by CONTRACTOR on behalf of COUNTY, agree to the same restrictions, safeguards, and conditions that apply to CONTRACTOR with respect to such PHI and to incorporate, when applicable, the relevant provisions of these provisions into each subcontract or sub-award to such agents or subcontractors. L. Employee Training and Discipline CONTRACTOR shall train and use reasonable measures to ensure compliance with the requirements of these provisions by employees who assist in the performance of functions or activities on behalf of COUNTY under this Agreement and use or disclose PHI and discipline such employees who intentionally violate any provisions of these provisions, including termination of employment. M. Termination for Cause Upon COUNTY’s knowledge of a material breach of these provisions by CONTRACTOR, COUNTY shall either: -14- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 1. Provide an opportunity for CONTRACTOR to cure the breach or end the violation and terminate this Agreement if CONTRACTOR does not cure the breach or end the violation within the time specified by COUNTY; or 2. Immediately terminate this Agreement if CONTRACTOR has breached a material term of these provisions and cure is not possible. 3. If neither cure nor termination is feasible, the COUNTY’s Privacy Officer shall report the violation to the Secretary of the U.S. Department of Health and Human Services. N. Judicial or Administrative Proceedings COUNTY may terminate this Agreement in accordance with the terms and conditions of this Agreement as written hereinabove; if: (1) CONTRACTOR is found guilty in a criminal proceeding for a violation of the HIPAA Privacy or Security Laws or the HITECH Act; or (2) a finding or stipulation that the CONTRACTOR has violated a privacy or security standard or requirement of the HITECH Act, HIPAA or other security or privacy laws in an administrative or civil proceeding in which the CONTRACTOR is a party. O. Effect of Termination Upon termination or expiration of this Agreement for any reason, CONTRACTOR shall return or destroy all PHI received from COUNTY (or created or received by CONTRACTOR on behalf of COUNTY) that CONTRACTOR still maintains in any form, and shall retain no copies of such PHI. If return or destruction of PHI is not feasible, it shall continue to extend the protections of these provisions to such information, and limit further use of such PHI to those purposes that make the return or destruction of such PHI infeasible. This provision shall apply to PHI that is in the possession of subcontractors or agents, if applicable, of CONTRACTOR. If CONTRACTOR destroys the PHI data, a certification of date and time of destruction shall be provided to the COUNTY by CONTRACTOR. Any DNA testing results in CONTRACTOR’s possession but not yet conveyed to the COUNTY upon termination of this Agreement for any reason shall be immediately transferred to the COUNTY. P. Disclaimer COUNTY makes no warranty or representation that compliance by CONTRACTOR with these provisions, the HITECH Act, HIPAA or the HIPAA regulations will be adequate or satisfactory for -15- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 CONTRACTOR’s own purposes or that any information in CONTRACTOR’s possession or control, or transmitted or received by CONTRACTOR, is or will be secure from unauthorized access, viewing, use, disclosure, or breach. CONTRACTOR is solely responsible for all decisions made by CONTRACTOR regarding the safeguarding of PHI. Q. Amendment The parties acknowledge that Federal and State laws relating to electronic data security and privacy are rapidly evolving and that amendment of these provisions may be required to provide for procedures to ensure compliance with such developments. The parties specifically agree to take such action as is necessary to amend this agreement in order to implement the standards and requirements of HIPAA, the HIPAA regulations, the HITECH Act and other applicable laws relating to the security or privacy of PHI. COUNTY may terminate this Agreement upon thirty (30) days written notice in the event that CONTRACTOR does not enter into an amendment providing assurances regarding the safeguarding of PHI that COUNTY in its sole discretion, deems sufficient to satisfy the standards and requirements of HIPAA, the HIPAA regulations and the HITECH Act. R. No Third-Party Beneficiaries Nothing express or implied in the terms and conditions of these provisions is intended to confer, nor shall anything herein confer, upon any person other than COUNTY or CONTRACTOR and their respective successors or assignees, any rights, remedies, obligations or liabilities whatsoever. S. Interpretation The terms and conditions in these provisions shall be interpreted as broadly as necessary to implement and comply with HIPAA, the HIPAA regulations and applicable State laws. The parties agree that any ambiguity in the terms and conditions of these provisions shall be resolved in favor of a meaning that complies and is consistent with HIPAA and the HIPAA regulations. T. Regulatory References A reference in the terms and conditions of these provisions to a section in the HIPAA regulations means the section as in effect or as amended. U. Survival The respective rights and obligations of CONTRACTOR as stated in this Section shall -16- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 survive the termination or expiration of this Agreement. V. No Waiver of Obligations No change, waiver or discharge of any liability or obligation hereunder on any one or more occasions shall be deemed a waiver of performance of any continuing or other obligations, or shall prohibit enforcement of any obligation on any other occasion. 11. AUDITS AND INSPECTIONS: The CONTRACTOR shall at any time during business hours, and as often as the COUNTY may deem necessary, make available to the COUNTY for examination all of its records and data with respect to the matters covered by this Agreement. The CONTRACTOR shall, upon request by the COUNTY, permit the COUNTY to audit and inspect all of such records and data necessary to ensure CONTRACTOR'S compliance with the terms of this Agreement. If this Agreement exceeds ten thousand dollars ($10,000.00), CONTRACTOR shall be subject to the examination and audit of the Auditor General for a period of three (3) years after final payment under contract (Government Code Section 8546.7). 12. NOTICES: The persons and their addresses having authority to give and receive notices under this Agreement include the following: COUNTY CONTRACTOR COUNTY OF FRESNO DNA Diagnostics Center, Inc. Child Support Services, Director One DDC Way 2220 Tulare Street, Suite 1900 Fairfield, OH 45014 Fresno, CA 93721 All notices between the COUNTY and CONTRACTOR provided for or permitted under this Agreement must be in writing and delivered either by personal service, by first-class United States mail, by an overnight commercial courier service, or by telephonic facsimile transmission. A notice delivered by personal service is effective upon service to the recipient. A notice delivered by first-class United States mail is effective three COUNTY business days after deposit in the United States mail, postage prepaid, addressed to the recipient. A notice delivered by an overnight commercial courier service is effective one COUNTY business day after deposit with the overnight commercial courier service, delivery fees prepaid, with delivery instructions given for next day delivery, addressed to the recipient. A notice delivered by telephonic facsimile is effective when transmission to the recipient is completed (but, if such transmission is completed outside of COUNTY business hours, then such delivery shall be deemed to be effective at the -17- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 next beginning of a COUNTY business day), provided that the sender maintains a machine record of the completed transmission. For all claims arising out of or related to this Agreement, nothing in this section establishes, waives, or modifies any claims presentation requirements or procedures provided by law, including but not limited to the Government Claims Act (Division 3.6 of Title 1 of the Government Code, beginning with section 810). 13. GOVERNING LAW: Venue for any action arising out of or related to this Agreement shall only be in Fresno County, California. The rights and obligations of the parties and all interpretation and performance of this Agreement shall be governed in all respects by the laws of the State of California. 14. DISCLOSURE OF SELF-DEALING TRANSACTIONS This provision is only applicable if the CONTRACTOR is operating as a corporation (a for-profit or non-profit corporation) or if during the term of the agreement, the CONTRACTOR changes its status to operate as a corporation. Members of the CONTRACTOR’s Board of Directors shall disclose any self-dealing transactions that they are a party to while CONTRACTOR is providing goods or performing services under this agreement. A self-dealing transaction shall mean a transaction to which the CONTRACTOR is a party and in which one or more of its directors has a material financial interest. Members of the Board of Directors shall disclose any self-dealing transactions that they are a party to by completing and signing a Self-Dealing Transaction Disclosure Form, attached hereto as Exhibit A and incorporated herein by reference, and submitting it to the COUNTY prior to commencing with the self-dealing transaction or immediately thereafter. 15. ENTIRE AGREEMENT: This Agreement constitutes the entire agreement between the CONTRACTOR and COUNTY with respect to the subject matter hereof and supersedes all previous Agreement negotiations, proposals, commitments, writings, advertisements, publications, and understanding of any nature whatsoever unless expressly included in this Agreement. In the event of any inconsistency in interpreting the documents which constitute this Agreement, the inconsistency shall be resolved by giving precedence in the following order of priority: (1) the text of this Agreement (excluding Exhibit "B", the COUNTY'S Request for Quotation/Proposal No. 18-058 and the CONTRACTOR'S -18- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Quote/Proposal in response thereto); (2) the COUNTY'S Request for Quotation/Proposal No. 18-058; and (3) the CONTRACTOR'S quotation/proposal made in response to COUNTY'S Request for Quotation/Proposal No. 18-058. /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// /// IN WITNESS WHEREOF, the parties hereto have executed th is Agreement as of the day and year 2 first hereinabove written. 3 4 CONTRACTOR 5 14-----+--f......,__.z...=......,..."'-'-=u..J..Jy=--=---- 6 7 l+J,:l,.W..U,1...J,,,1:.i..w.a.~..i.....1,..1,,.kl,I.Ll,l,l,.u..i...,~a...i.Jiu.u.!.w> 8 9 10 11 12 13 14 15 16 17 18 Fairfield OH 450 14 Mailing Address FOR ACCOUNTING USE ONLY: Department of Chi ld Support Services ORG No .: 5110 19 Account No.: 7295 5111800064 Requisition No .: 20 21 Department of Social Services ORG No.: 56107001 22 Account No.: 7870 23 24 25 26 27 28 Requisition No .: 5611900622 COUNTY OF FRESNO hairperson of the Board of he County of Fresno ATTEST: Bernice E. Seidel Clerk of the Board of Supervisors County of Fresno, State of California -19 - COUNTY OF FRESNO REQUEST FOR QUOTATION NUMBER: 18-058 DNA - PATERNITY TESTING SERVICES Issue Date: July 10, 2018 Closing Date: AUGUST 15, 2018 AT 2:00 P.M. All Questions and Responses must be electronically submitted on the Bid Page on Public Purchase. For assistance, contact Darren Howard at Phone (559) 600-7110. BIDDER TO COMPLETE Undersigned agrees to furnish the commodity or service stipulated in the attached response at the prices and terms stated in this RFQ. Bid must be signed and dated by an authorized officer or employee. Except as noted on individual items, the following will apply to all items in the Quotation Schedule: x A cash discount of % days will apply. County does not accept terms less than 15 days. COMPANY ADDRESS CITY STATE ZIP CODE ( ) ( ) TELEPHONE NUMBER FACSIMILE NUMBER E-MAIL ADDRESS SIGNATURE PRINT NAME TITLE Purchasing Use:DH:st ORG/Requisition:5110 / 5111800064 Exhibit B Page 1 of 188Exhibit B TABLE OF CONTENTS PAGE KEY DATES....................................................................................................................3 OVERVIEW.....................................................................................................................3 BID INSTRUCTIONS ......................................................................................................4 GENERAL REQUIREMENTS & CONDITIONS...............................................................5 INSURANCE REQUIREMENTS ...................................................................................11 PARTICIPATION...........................................................................................................13 SCOPE OF WORK........................................................................................................14 REFERENCE LIST........................................................................................................16 COMPLY/NOT COMPLY...............................................................................................17 QUOTATION SCHEDULE.............................................................................................19 CHECK LIST.................................................................................................................20 Exhibit B Page 2 of 188 KEY DATES RFQ Issue Date: July 10, 2018 Vendor Conference: July 24, 2018 at 10:00 AM County of Fresno - Purchasing 4525 E. Hamilton Avenue, 2nd Floor Fresno, CA 93702 Written Questions for RFQ Due: July 31, 2018 at 10:00 AM Questions must be submitted on the Bid Page at Public Purchase. RFQ Closing Date: August 15, 2018 at 2:00 P.M. Quotations must be electronically submitted on the Bid Page. VENDOR CONFERENCE & SITE INSPECTION: A vendor conference will be held in which the scope of the project and quotation requirements will be explained. Addenda will be prepared and distributed to all bidders only if necessary to clarify substantive items raised during the vendor conference. Bidders are to contact Darren Howard at County of Fresno - Purchasing, (559) 600-7119, if they are planning to attend. OVERVIEW The County of Fresno on behalf of the Department of Child Support Services is seeking proposals from qualified vendors to provide Deoxyribonucleic Acid (DNA) Genetic Parentage Testing as outlined in Exhibit “A”, California Family Code Section 7550-7558. The County of Fresno Department of Child Support Services (DCSS) is required to maintain a program for the enforcement of support and determination of paternity. The County’s goal is to employ a laboratory that can provide objective evidence to assist the Department of Child Support Services in resolving paternity disputes. In addition, the Department of Social Services (DSS) will have a need for a minimal amount of paternity testing services for their respective programs. The determination of paternity in DSS assists in the provision of Child Welfare Services. Each department listed will be invoiced separately, receive the test results, and other pertinent information. The Department of Child Support Services will require a detailed invoice with each of the child support case numbers listed with the dollar amount charged. The test volume averages around one hundred samples per month. Currently, the testing is performed by DNA Diagnostics Center, using buccal swabs and the fee is $29.25 per individual. The current agreement terminates on December 31, 2018. Exhibit B Page 3 of 188 BID INSTRUCTIONS x Bidders must electronically submit bid package in pdf format, no later than the quotation closing date and time as stated on the front of this document, to the Bid Page on Public Purchase. The County will not be responsible for and will not accept late bids due to slow internet connection or incomplete transmissions. x Bids received after the closing time will NOT be considered. x All quotations shall remain firm for 180 days. x Interpretation: Should any discrepancies or omissions be found in the bid specifications or doubt as to their meaning, the bidder shall notify the Buyer in writing at once. The County shall not be held responsible for verbal interpretations. Questions regarding the bid must be received by Purchasing prior to the date and time stated within this document. All addenda issued shall be in writing, duly issued by Purchasing and incorporated into the contract. x ISSUING AGENT/AUTHORIZED CONTACT: This RFQ has been issued by County of Fresno, Purchasing. Purchasing shall be the vendor’s sole point of contact with regard to the RFQ, its content, and all issues concerning it. All communication regarding this RFQ shall be directed to an authorized representative of County Purchasing. The specific buyer managing this RFQ is identified on the cover page, along with his or her telephone number, and he or she should be the primary point of contact for discussions or information pertaining to the RFQ. Contact with any other County representative, including elected officials, for the purpose of discussing this RFQ, its content, or any other issue concerning it, is prohibited unless authorized by Purchasing. Violation of this clause, by the vendor having unauthorized contact (verbally or in writing) with such other County representatives, may constitute grounds for rejection by Purchasing of the vendor’s quotation. The above stated restriction on vendor contact with County representatives shall apply until the County has awarded a purchase order or contract to a vendor or vendors, except as follows. First, in the event that a vendor initiates a formal protest against the RFQ, such vendor may contact the appropriate individual, or individuals who are managing that protest as outlined in the County’s established protest procedures. All such contact must be in accordance with the sequence set forth under the protest procedures. Second, in the event a public hearing is scheduled before the Board of Supervisors to hear testimony prior to its approval of a purchase order or contract, any vendor may address the Board. x APPEALS: Appeals must be submitted in writing within seven (7) working days after notification of proposed recommendations for award. A “Notice of Award” is not an indication of County’s acceptance of an offer made in response to this RFQ. Appeals shall be submitted to County of Fresno Purchasing, 4525 E. Hamilton Avenue 2nd Floor, Fresno, California 93702-4599 and in Word format to gcornuelle@FresnoCountyCA.gov. Appeals should address only areas regarding RFQ contradictions, procurement errors, quotation rating discrepancies, legality of procurement context, conflict of interest, and inappropriate or unfair competitive procurement grievance regarding the RFQ process. Purchasing will provide a written response to the complainant within seven (7) working days unless the complainant is notified more time is required. If the appealing bidder is not satisfied with the decision of Purchasing, he/she shall have the right to appeal to the County Administrative Office (CAO) within seven (7) working days after Purchasing’s notification; if the appealing bidder is not satisfied with CAO’s decision, the final appeal is with the Board of Supervisors. Please contact Purchasing if the appeal will be going to the Board of Supervisors. Exhibit B Page 4 of 188 GENERAL REQUIREMENTS & CONDITIONS LOCAL VENDOR PREFERENCE AND DISABLED VETERAN BUSINESS ENTERPRISE BID PREFERENCE:The Local Vendor Preference and Disabled Veteran Business Enterprise Preference do not apply to this Request for Quotation. DEFINITIONS:The terms Bidder, Proposer, Contractor and Vendor are all used interchangeably and refer to that person, partnership, corporation, organization, agency, etc. which is offering the quotation and is identified on page one of this Request For Quotation (RFQ). INTERPRETATION OF RFQ: Vendors must make careful examination of the requirements, specifications and conditions expressed in the RFQ and fully inform themselves as to the quality and character of services required. If any person planning to submit a quotation finds discrepancies in or omissions from the RFQ or has any doubt as to the true meaning or interpretation, correction thereof may be requested in writing from Purchasing by July 31, 2018 at 10:00 AM, cut-off. Questions must be submitted on the Bid Page at Public Purchase or contact Darren Howard at (559) 600- 7110. NOTE: Time constraints will prevent County from responding to questions submitted after the cut-off date. Any change in the Request for Quotation will be made by written addendum issued by the County. The County will not be responsible for any other explanations or interpretations. AWARD: Award will be made to the vendor(s) offering the services, products, prices, delivery, equipment and system deemed to be to the best advantage of the County. Past performance (County contracts within the past seven years) and references may factor into awarding of a contract. The County shall be the sole judge in making such determination. Award Notices are tentative: Acceptance of an offer made in response to this RFQ shall occur only upon execution of an agreement by both parties or issuance of a valid written Purchase Order by Fresno County Purchasing. RIGHT TO REJECT BIDS:The County reserves the right to reject any and all bids and to waive informalities or irregularities in bids. Failure to respond to all questions or not to supply the requested information could result in rejection of your quotation. CODES AND REGULATIONS: All work and material to conform to all applicable Federal, State, local and special district building codes, laws, ordinances, and regulations. TAXES: The quoted amount must include all applicable taxes. If taxes are not specifically identified in the quotation it will be assumed that they are included in the total quoted. SALES TAX: Fresno County pays California State Sales Tax in the amount of 7.975% regardless of vendor's place of doing business. TAXES, PERMITS & FEES:The successful bidder shall pay for and include all federal, state and local taxes direct or indirect upon all materials; pay all fees for, and obtain all necessary permits and licenses, unless otherwise specified herein. TAXES, CHARGES AND EXTRAS: A)DO NOT include Federal Excise Tax. County is exempt under Registration No. 94-73-03401-K. B) County is exempt from Federal Transportation Tax. Exemption certificate is not required where shipping papers show consignee as County of Fresno. C) Charges for transportation, containers, packing, etc. will not be paid unless specified in bid. SPECIFICATIONS AND EQUALS:Brand names, where used, are a means of establishing quality and style. Bidders are invited to quote their equals. Alternate offers are to be supported by literature, which fully describes items that you are bidding. Exhibit B Page 5 of 188 No exceptions to or deviations from this specification will be considered unless each exception or deviation is specifically stated by the bidder, in the designated places. If no exceptions or deviations are shown, the bidder will be required to furnish items exactly as specified herein. The burden of proof of compliance with this specification is the responsibility of the bidder. LITERATURE:Bidders shall submit literature, which fully describes items on which they are bidding, not later than the closing date of this bid. Any and all literature submitted must be stamped with bidders name and address. MERCHANDISE RETURNABLE FOR FULL CREDIT:Bidder agrees to accept for full credit any merchandise sold by him on contract or award resulting from this bid, if returned in good condition by the County. GUARANTEE AGAINST DEFECTS:All items are to carry a full guarantee against defects in materials and workmanship and guarantee against breakage and other malfunctions when performing work for which they are designed. MINOR DEVIATIONS:The County reserves the right to negotiate minor deviations from the prescribed terms, conditions and requirements with the selected vendor. BIDDERS’ LIABILITIES:County of Fresno will not be held liable for any cost incurred by vendors in responding to the RFQ. PRICE RESPONSIBILITY:The selected vendor will be required to assume full responsibility for all services and activities offered in the quotation, whether or not they are provided directly. Further, the County of Fresno will consider the selected vendor to be the sole point of contact with regard to contractual matters, including payment of any and all charges resulting from the contract. The contractor may not subcontract or transfer the contract, or any right or obligation arising out of the contract, without first having obtained the express written consent of the County. PRICES:Bidder agrees that prices quoted are for the contract period, and in the event of a price decline such lower prices shall be extended to the County of Fresno. Prices shall be quoted F.O.B. destination. CONFIDENTIALITY:Bidders shall not disclose information about the County's business or business practices and safeguard confidential data which vendor staff may have access to in the course of system implementation. HIPAA: All services performed by vendor shall be in strict conformance with all applicable Federal, State of California and/or local laws and regulations relating to confidentiality, including but not limited to, California Civil Code, California Welfare and Institutions Code, Health and Safety Code, California Code of Regulations, Code of Federal Regulations. Vendor shall submit to County’s monitoring of said compliance. Vendor may be a business associate of County, as that term is defined in the “Privacy Rule” enacted by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). As a HIPAA Business Associate, vendor may use or disclose protected health information (“PHI”) to perform functions, activities or services for or on behalf of County as specified by the County, provided that such use or disclosure shall not violate HIPAA and its implementing regulations. The uses and disclosures if PHI may not be more expansive than those applicable to County, as the “Covered Entity” under HIPAA’s Privacy Rule, except as authorized for management, administrative or legal responsibilities of the Business Associate. Vendor shall not use or further disclose PHI other than as permitted or required by the County, or as required by law without written notice to the County. Vendor shall ensure that any agent, including any subcontractor, to which vendor provides PHI received from, or created or received by the vendor on behalf of County, shall comply with the same restrictions and conditions with respect to such information. Exhibit B Page 6 of 188 NEWS RELEASE:Vendors shall not issue any news releases or otherwise release information to any third party about this RFQ or the vendor's quotation without prior written approval from the County of Fresno. BACKGROUND REVIEW: The County reserves the right to conduct a background inquiry of each proposer/bidder which may include collection of appropriate criminal history information, contractual and business associations and practices, employment histories and reputation in the business community. By submitting a quotation/bid to the County, the vendor consents to such an inquiry and agrees to make available to the County such books and records the County deems necessary to conduct the inquiry. ADDENDA: In the event that it becomes necessary to revise any part of this RFQ, addenda will be provided to all agencies and organizations that receive the basic RFQ. CONFLICT OF INTEREST:The County shall not contract with, and shall reject any bid or quotation submitted by the persons or entities specified below, unless the Board of Supervisors finds that special circumstances exist which justify the approval of such contract: 1.Employees of the County or public agencies for which the Board of Supervisors is the governing body. 2.Profit-making firms or businesses in which employees described in Subsection (1) serve as officers, principals, partners or major shareholders. 3.Persons who, within the immediately preceding twelve (12) months, came within the provisions of Subsection (1), and who were employees in positions of substantial responsibility in the area of service to be performed by the contract, or participated in any way in developing the contract or its service specifications. 4.Profit-making firms or businesses in which the former employees described in Subsection (3) serve as officers, principals, partners or major shareholders. 5.No County employee whose position in the County enables him to influence the selection of a contractor for this RFQ, or any competing RFQ, and no spouse or economic dependent of such employee, shall be employees in any capacity by a bidder, or have any other direct or indirect financial interest in the selection of a contractor. INVOICING:All invoices are to be delivered in duplicate to the ordering department. Each invoice shall reference the purchase order or contract number. The contractor shall obtain the “invoice to” address when receiving the order. PAYMENT:County will make partial payments for all purchases made under the contract/purchase order and accumulated during the month. Terms of payment will be net forty-five (45) days. County will consider the Bidder’s Cash discount Offer, in lieu of the net forty-five (45) days payment terms. CONTRACT TERM: It is County’s intent to contract with the successful bidder for a term of three (3) years. RENEWAL:Agreement may be renewed for a potential of two (2) one (1) year periods, based on the mutual written consent of all parties. QUANTITIES:Quantities shown in the bid schedule are approximate and the County guarantees no minimum amount. The County reserves the right to increase or decrease quantities. ORDERING: Orders will be placed as required by County of Fresno Department of Child Support Services and the Department of Social Services. TERMINATION:The County reserves the right to terminate any resulting contract upon written notice. INDEPENDENT CONTRACTOR: In performance of the work, duties, and obligations assumed by Contractor under any ensuing Agreement, it is mutually understood and agreed that CONTRACTOR, including any and all of Contractor’s officers, agents, and employees will at all times be acting and performing as an independent contractor, and shall act in an independent capacity and not as an officer, agent, servant, employee, joint venturer, partner, or associate of the COUNTY. Furthermore, County shall Exhibit B Page 7 of 188 have no right to control or supervise or direct the manner or method by which Contractor shall perform its work and function. However, County shall retain the right to administer this Agreement so as to verify that Contractor is performing its obligations in accordance with the terms and conditions thereof. Contractor and County shall comply with all applicable provisions of law and the rules and regulations, if any, of governmental authorities having jurisdiction over matters the subject thereof. Because of its status as an independent contractor, Contractor shall have absolutely no right to employment rights and benefits available to County employees. Contractor shall be solely liable and responsible for providing to, or on behalf of, its employees all legally-required employee benefits. In addition, Contractor shall be solely responsible and save County harmless from all matters relating to payment of Contractor's employees, including compliance with Social Security, withholding, and all other regulations governing such matters. It is acknowledged that during the term of the Agreement, Contractor may be providing services to others unrelated to the County or to the Agreement. SELF-DEALING TRANSACTION DISCLOSURE:Contractor agrees that when operating as a corporation (a for-profit or non-profit corporation), or if during the term of the agreement the Contractor changes its status to operate as a corporation, members of the Contractor’s Board of Directors shall disclose any self-dealing transactions that they are a party to while Contractor is providing goods or performing services under the agreement with the County. A self-dealing transaction shall mean a transaction to which the Contractor is a party and in which one or more of its directors has a material financial interest. Members of the Board of Directors shall disclose any self-dealing transactions that they are a party to by completing and signing a Fresno County Self-Dealing Transaction Disclosure Form and submitting it to the County prior to commencing with the self-dealing transaction or immediately thereafter. HOLD HARMLESS CLAUSE: Contractor agrees to indemnify, save, hold harmless and at County's request, defend the County, its officers, agents and employees, from any and all costs and expenses (including attorney’s fees and costs), damages, liabilities, claims and losses occurring or resulting to County in connection with the performance, or failure to perform, by Contractor, its officers, agents or employees under this Agreement and from any and all costs and expenses (including attorney’s fees and costs), damages, liabilities, claims and losses occurring or resulting to any person, firm or corporation who may be injured or damaged by the performance, or failure to perform, of Contractor, its officers, agents or employees under this Agreement. DISPUTE RESOLUTION:The ensuing contract shall be governed by the laws of the state of California. Any claim which cannot be amicably settled without court action will be litigated in the U.S. District Court for the Eastern District of California in Fresno, CA or in a state court for Fresno County. DEFAULT: In case of default by the selected bidder, the County may procure the services from another source and may recover the loss occasioned thereby from any unpaid balance due the selected bidder, or by any other legal means available to the County. Regardless of F.O.B. point, vendor agrees to bear all risks of loss, injury or destruction to goods and materials ordered herein which occur prior to delivery and such loss, injury or destruction shall not release vendor from any obligation hereunder ASSIGNMENTS:The ensuing proposed contract will provide that the vendor may not assign any payment or portions of payments without prior written consent of the County of Fresno. ASSURANCES: Any contract awarded under this RFQ must be carried out in full compliance with the Civil Rights Act of 1964, the Americans With Disabilities Act of 1990, their subsequent amendments, and any and all other laws protecting the rights of individuals and agencies. The County of Fresno has a zero tolerance for discrimination, implied or expressed, and wants to ensure that policy continues under this RFQ. The contractor must also guarantee that services, or workmanship, provided will be performed in compliance with all applicable local, state, or federal laws and regulations pertinent to the types of services, or project, of the nature required under this RFQ. In addition, the contractor may be required to provide evidence substantiating that their employees have the necessary skills and training to perform the required services or work. Exhibit B Page 8 of 188 OBLIGATIONS OF CONTRACTOR:Contractor warrants on behalf of itself and all subcontractors engaged for the performance of the ensuing contract that only persons authorized to work in the United States pursuant to the Immigration Reform and Control Act of 1986 and other applicable laws shall be employed in the performance of the work hereunder. TIE BIDS:With all other factors being equal, the contract shall be awarded to the Fresno County vendor or, if neither or both are Fresno County vendors, the tied vendors will be granted the opportunity to submit new bids or the entire bid may be rejected and re-bid. If the General Requirements of the RFQ state that they are applicable, the provisions of the Fresno County Local Vendor Preference shall take priority over this paragraph. DATA SECURITY:Individuals and/or agencies that enter into a contractual relationship with the County for the purpose of providing services must employ adequate controls and data security measures, both internally and externally to ensure and protect the confidential information and/or data provided to contractor by the County, preventing the potential loss, misappropriation or inadvertent access, viewing, use or disclosure of County data including sensitive or personal client information; abuse of County resources; and/or disruption to County operations. Individuals and/or agencies may not connect to or use County networks/systems via personally owned mobile, wireless or handheld devices unless authorized by County for telecommuting purposes and provide a secure connection; up to date virus protection and mobile devices must have the remote wipe feature enabled. Computers or computer peripherals including mobile storage devices may not be used (County or Contractor device) or brought in for use into the County’s system(s) without prior authorization from County’s Chief Information Officer and/or designee(s). No storage of County’s private, confidential or sensitive data on any hard-disk drive, portable storage device or remote storage installation unless encrypted according to advance encryption standards (AES of 128 bit or higher). The County will immediately be notified of any violations, breaches or potential breaches of security related to County’s confidential information, data and/or data processing equipment which stores or processes County data, internally or externally. County shall provide oversight to Contractor’s response to all incidents arising from a possible breach of security related to County‘s confidential client information. Contractor will be responsible to issue any notification to affected individuals as required by law or as deemed necessary by County in its sole discretion. Contractor will be responsible for all costs incurred as a result of providing the required notification. AUDITS AND RETENTION: The Contractor shall maintain in good and legible condition all books, documents, papers, data files and other records related to its performance under this contract. Such records shall be complete and available to Fresno County, the State of California, the federal government or their duly authorized representatives for the purpose of audit, examination, or copying during the term of the contract and for a period of at least three (3) years following the County's final payment under the contract or until conclusion of any pending matter (e.g., litigation or audit), whichever is later. Such records must be retained in the manner described above until all pending matters are closed. EPAYMENT OPTION: The County of Fresno provides an Epay Program which involves payment of invoices by a secure Visa account number assigned to the supplier after award of contract. Notification of payments and required invoice information are issued to the supplier's designated Accounts Receivable contact by e- mail remittance advice at time of payment. To learn more about the benefits of an Epay Program, how it works, and obtain answers to frequently asked questions, click or copy and paste the following URL into your browser: www.bankofamerica.com/epayablesvendors or call Fresno County Accounts Payable, 559-600- 3609. Exhibit B Page 9 of 188 SUBCONTRACTORS: List all subcontractors that would perform work in excess of one/half of one percent of the total amount of your bid, and state general type of work such subcontractor would be performing. The primary contractor is not relieved of any responsibility by virtue of using a subcontractor: Exhibit B Page 10 of 188 INSURANCE REQUIREMENTS INSURANCE: Without limiting the County’s right to obtain indemnification from Contractor or any third parties, Contractor, at its sole expense, shall maintain in full force and effect, the following insurance policies or a program of self-insurance, including but not limited to, an insurance pooling arrangement or Joint Powers Agreement (JPA) throughout the term of the Agreement: A. Commercial General Liability: Commercial General Liability Insurance with limits of not less than Two Million Dollars ($2,000,000.00) per occurrence and an annual aggregate of Four Million Dollars ($4,000,000.00). This policy shall be issued on a per occurrence basis. County may require specific coverage including completed operations, product liability, contractual liability, Explosion-Collapse- Underground, fire legal liability or any other liability insurance deemed necessary because of the nature of the contract. B. Automobile Liability: Comprehensive Automobile Liability Insurance with limits of not less than One Million Dollars ($1,000,000.00) per accident for bodily injury and for property damages. Coverage should include any auto used in connection with this Agreement. C. Professional Liability: If Contractor employs licensed professional staff, (e.g., Ph.D., R.N., L.C.S.W., M.F.C.C.) in providing services, Professional Liability Insurance with limits of not less than One Million Dollars ($1,000,000.00) per occurrence, Three Million Dollars ($3,000,000.00) annual aggregate. This coverage shall be issued on a per claim basis. Contractor agrees that it shall maintain, at its sole expense, in full force and effect for a period of three years following the termination of this Agreement, one or more policies of professional liability insurance with limits of coverage as specified herein. D. Worker's Compensation: A policy of Worker's Compensation insurance as may be required by the California Labor Code. Additional Requirements Relating to Insurance: Contractor shall obtain endorsements to the Commercial General Liability insurance naming the County of Fresno, its officers, agents, and employees, individually and collectively, as additional insured, but only insofar as the operations under this Agreement are concerned. Such coverage for additional insured shall apply as primary insurance and any other insurance, or self-insurance, maintained by County, its officers, agents and employees shall be excess only and not contributing with insurance provided under Contractor's policies herein. This insurance shall not be cancelled or changed without a minimum of thirty (30) days advance written notice given to County. Contractor hereby waives its right to recover from County, its officers, agents, and employees any amounts paid by the policy of worker’s compensation insurance required by this Agreement. Contractor is solely responsible to obtain any endorsement to such policy that may be necessary to accomplish such waiver of subrogation, but Contractor’s waiver of subrogation under this paragraph is effective whether or not Contractor obtains such an endorsement. Within thirty (30) days from the date Contractor executes this Agreement, Contractor shall provide certificates of insurance and endorsement as stated above for all of the foregoing policies, as required herein, to the County of Fresno, Attn: Ryan Ramos, Department of Child Support Services, P.O. Box 12946, Fresno, CA 93779, stating that such insurance coverage have been obtained and are in full force; that the County of Fresno, its officers, agents and employees will not be responsible for any premiums on the policies; that such Commercial General Liability insurance names the County of Fresno, its officers, agents and employees, individually and collectively, as additional insured, but only insofar as the operations under this Agreement are concerned; that such coverage for additional insured shall apply as primary insurance and any other insurance, or self-insurance, maintained by County, its officers, agents and employees, shall be excess only and not contributing with insurance provided under Contractor's policies herein; and that this insurance shall not be cancelled or changed without a minimum of thirty (30) days advance, written notice given to County. In the event Contractor fails to keep in effect at all times insurance coverage as herein provided, the County may, in addition to other remedies it may have, suspend or terminate this Agreement upon the occurrence of such event. Exhibit B Page 11 of 188 All policies shall be with admitted insurers licensed to do business in the State of California. Insurance purchased shall be purchased from companies possessing a current A.M. Best, Inc. rating of A FSC VII or better. Exhibit B Page 12 of 188 BIDDER TO COMPLETE THE FOLLOWING: PARTICIPATION The County of Fresno is a member of the Central Valley Purchasing Group. This group consists of Fresno, Kern, Kings, and Tulare Counties and all governmental, tax supported agencies within these counties. Whenever possible, these and other tax supported agencies co-op (piggyback) on contracts put in place by one of the other agencies. Any agency choosing to avail itself of this opportunity, will make purchases in their own name, make payment directly to the contractor, be liable to the contractor and vice versa, per the terms of the original contract, all the while holding the County of Fresno harmless. If awarded this contract, please indicate whether you would extend the same terms and conditions to all tax supported agencies within this group as you are proposing to extend to Fresno County. Yes, we will extend contract terms and conditions to all qualified agencies within the Central Valley Purchasing Group and other tax supported agencies. No, we will not extend contract terms to any agency other than the County of Fresno. (Authorized Signature) Title Exhibit B Page 13 of 188 SCOPE OF WORK The successful bidder will provide Deoxyribonucleic Acid (DNA) Genetic Parentage Testing services for the County in order to establish parentage for children within and outside of the County. If there are any services that a bidder is not able to provide, this should be noted and explained fully. Bidders must complete the Comply/ Not Comply and Submittal Requirements, contained in this RFQ Currently, the testing is primarily done by buccal swab. Testing volume averages around one hundred samples per month. Draws are currently completed every Tuesday from 8:00 a.m. to 5:00 p.m. and every other Thursday from 1:00 p.m. to 5:00 p.m. The County is requesting a three (3) year contract, with two (2) optional 1-year renewals. The effective date of the contract will be January 1, 2019. The current vendor will complete all partial case samples in their possession at the end of the current contract. Exhibit B Page 14 of 188 SUBMITTAL REQUIREMENTS All bidders shall provide sufficient information to enable a complete evaluation of the laboratory’s technical approach, project personnel, management operations, corporate experience, and pricing. Pursuant to instructions included in this RFQ, Scope of Work and Submittal Requirements, bidders shall include a response to the following: 1. Bids shall include a discussion of the proposed technical approach and a summary of the laboratory’s specific testing experience and include any experience with governmental entities listing unit and location. 2. Provide your laboratory’s experience, performed under AABB accreditation, with California Child Support casework and trials. 3. Contractor shall maintain an organizational structure and sufficient staff to administer and supervise all of the functions for which they are responsible under the terms of this RFQ and all applicable laws. Provide the names and resumes (curriculum vitae) of key staff members. 4. Bids must state method of testing to be performed. Include: a. All DNA probes used b. Source of DNA probes used c. Ownership of national database d. Size of isolated national database e. Ethnicity by percentage of national database (The Central Valley has a large Asian population that does not exist through the United States) 5. Provide a statement regarding your ability to provide services to varied ethnic populations. 6. Indicate in the bid whether the organization has conducted, documented, and published validation studies on their databases and biostatistical methods to ensure success on meeting California Kelly-Frye challenges. If so, copies of said studies are to be submitted with the bid. 7. Provide the proposed day or days the draws/samples are to be completed/obtained, and specimen requirements. 8. Provide your median and maximum laboratory wide turnaround time. 9. Any special proposed uses of County of Fresno resources and personnel need to be noted. 10. A list of any special services or access to other experts and resources which the firm maintains for the purpose of this contract need to be noted. 11. Provide a copy of your AABB accreditation. 12. Provide a sample Test Result report. Exhibit B Page 15 of 188 VENDOR MUST COMPLETE AND RETURN WITH REQUEST FOR QUOTATION. Firm: REFERENCE LIST Provide a list of at least five (5) customers for whom you have recently provided similar products/services. If you have held a contract for similar services with the County of Fresno within the past seven (7) years, list the County as one of your customers. Please list the person most familiar with your contract. Be sure to include all requested information. Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Failure to provide a list of at least five (5) customers may be cause for rejection of this RFQ. Exhibit B Page 16 of 188 COMPLY/NOT COMPLY Compliance and understanding of the specification is to be noted by marking “COMPLY” on the line provided to the right of the specification. Non-compliance is to be indicated by marking “NOT COMPLY” on the line. A detailed statement explaining why they fail to meet the stated specification or requirement must accompany all non-compliant items. Failure to mark this page could result in your quotation being non-responsive. BIDDER TO COMPLETE THE FOLLOWING: COMPLY/ NOT COMPLY 1.Contractor shall supervise the drawing of samples, which shall include completion of identification papers, a photograph, and chain of custody documentation from drawing to laboratory, and within the laboratory. Samples will need to be retained for a minimum of seven to ten (7-10) years. 2.Contractor shall continue to test each individual sample until evidence for non- paternity is obtained or a likelihood of paternity with a Paternity Index of 100 (probability of paternity > 99%) or greater is obtained or until all available systems at the disposal of the laboratory are used. 3.Contractor shall provide Special Request Testing. At the request of the County, the Contractor shall test in designated systems in individual cases although all of such systems may not be necessary to reach a paternity index of 100. 4.Contractor should utilize phlebotomists or trained specimen collectors for the buccal swab testing, however phlebotomists shall be used for blood testing. Independent contractors utilized by your organization for specimen collection are considered subcontractors of your organization under the terms of this contract. 5.Contractor shall be certified as an accredited DNA parentage-testing laboratory by the AABB (formerly the American Association of Blood Banks). 6.Contractor shall provide test result reports to the County in a standard matter which shall include the following: a. Table of Results b. Interpretation of results c. Probability of paternity d. Effect of prior probability and likelihood of paternity e. Power of exclusion (power to exclude a party when there is a question of the possibility of fatherhood between two or more males such as the case with two brothers or cousins with a close genetic background). f. Chain of Custody documentation 7.Contractor shall ensure guardian consent is received for the minor mother’s sample and the alleged minor father’s sample, as well as the infant or child’s sample. Exhibit B Page 17 of 188 BIDDER TO COMPLETE THE FOLLOWING: COMPLY/ NOT COMPLY 8.Contractor’s maximum turnaround time may not exceed four weeks from drawing to issuance of report. Performance for Fresno County shall meet or exceed laboratory wide performance 9.Contractor shall furnish an expert or experts to testify as to the results of the tests. Expert witnesses are called to testify on average three to six times per year. The expert shall currently possess education, training, and expertise consistent with industry standards. The expert witness shall be available on a twenty-four hour “on call” basis (available to testify within twenty-four hours after notification). 10.The Contractor’s expert or experts shall be available to consult with County staff, and capable of calculating paternity indices based on comparison with a related adult male, and based on family studies, as well as in the standard format. 11.Fresno County will provide a drawing station located at the B.F. Sisk Courthouse for the Department of Child Support Services, however the Contractor shall provide the ability to draw at other locations if necessary, i.e., jail, hospitals, morgue, etc. 12.When an expedited draw is needed, as in the case of a deceased individual before the DNA degrades, the Contractor shall collect DNA specimens from a deceased person within twenty-four hours after notification. It is anticipated that no more than five such collections would occur each calendar year. 13.Contractor shall maintain confidentiality and may not use or disclose any information concerning applicants. Recipients will be limited to courts, law enforcement officials, and other public officials for purposes directly connected with the administration of the state plan for establishing paternity and enforcing child support, including establishing eligibility, determining amounts of assistance, identifying and locating putative or deserting parents, establishing paternity, enforcing investigation, prosecution or criminal or civil proceedings, conducted in connection with the administration of the state plan. No information shall be disclosed to any committee or legislative body which identifies any applicant or recipient of public assistance by name or address. 14.The charge per individual shall include drawing, completion of identification papers, packaging of the sample for shipment, testing, and issuance of the report. Costs for shipment shall be separately stated. 15.Fee schedule shall be firm for the duration of the contract. 16.Contractor shall provide monthly invoices. Payment for the services provided will be made monthly after the test results and invoice has been received. **Please Note: Failure to comply to all services requested will not automatically disqualify any Bidder. Exhibit B Page 18 of 188 QUOTATION SCHEDULE Testing with buccal swabs $ per person Testing with blood samples $ per person Additional testing required to reach a paternity index of 100 $ per person Consultation by laboratory with other laboratories to confirm unusual or uncertain results $ per person Drawing and identification fee (Fresno County area) $ per person Drawing and identification fee (outside Fresno County) $ per person Expert witness fee (court or deposition time) $ per person Retesting requested by laboratory $ per person Miscellaneous expense (define) $ per person Exhibit B Page 19 of 188 CHECK LIST This Checklist is provided to assist the vendors in the preparation of their bid response. Included in this list, are important requirements and is the responsibility of the bidder to submit with the bid package in order to make the bid compliant. Because this checklist is just a guideline, the bidder must read and comply with the bid in its entirety. Check off each of the following: 1.The Request for Quotation (RFQ) has been signed and completed. 2.Addenda, if any, have been signed and included in the bid package. 3.The completed Reference List as provided with this RFQ. 4.The Quotation Schedule as provided with this RFQ has been completed, price reviewed for accuracy and any corrections initialed. 5.Indicate all of bidder exceptions to the County’s requirements, conditions and specifications as stated within this RFQ. 6.The Participation page as provided within this RFQ has been signed and included 7.Bidder to Complete page as provided with this RFQ. 8.Verification of Contractor’s License and the Department of Consumer Affairs – Contractors’ State License Board. 9.Return checklist with RFQ response. 10.Completed RFQ in pdf format, electronically submitted to the Bid Page on Public Purchase. Exhibit B Page 20 of 188 2005 California Family Code Sections 7550- 7558 CHAPTER 2. BLOOD TESTS TO DETERMINE PATERNITY FAMILY.CODE SECTION 7550-7558 7550. This chapter may be cited as the Uniform Act on Blood Tests to Determine Paternity. (Amended by Stats. 1993, Ch. 219, Sec. 174. Effective January 1, 1994.) 7551. In a civil action or proceeding in which paternity is a relevant fact, the court may upon its own initiative or upon suggestion made by or on behalf of any person who is involved, and shall upon motion of any party to the action or proceeding made at a time so as not to delay the proceedings unduly, order the mother, child, and alleged father to submit to genetic tests. If a party refuses to submit to the tests, the court may resolve the question of paternity against that party or enforce its order if the rights of others and the interests of justice so require. A party’s refusal to submit to the tests is admissible in evidence in any proceeding to determine paternity. For the purposes of this chapter, “genetic tests” means any genetic test that is generally acknowledged as reliable by accreditation bodies designated by the United States Secretary of Health and Human Services. (Amended by Stats. 1997, Ch. 599, Sec. 36. Effective January 1, 1998.) 7551.5. All hospitals, local child support agencies, welfare offices, and family courts shall facilitate genetic tests for purposes of enforcement of this chapter. This may include having a health care professional available for purposes of extracting samples to be used for genetic testing. (Added by Stats. 1999, Ch. 652, Sec. 6. Effective January 1, 2000.) Exhibit B Page 21 of 188 7552. The genetic tests shall be performed by a laboratory approved by any accreditation body that has been approved by the United States Secretary of Health and Human Services. Any party or person at whose suggestion the tests have been ordered may demand that other experts, qualified as examiners of blood types, perform independent tests under order of the court, the results of which may be offered in evidence. The number and qualifications of these experts shall be determined by the court. (Amended by Stats. 1998, Ch. 485, Sec. 66. Effective January 1, 1999.) 7552.5. (a) A copy of the results of all genetic tests performed under Section 7552 or 7558 shall be served upon all parties, by any method of service authorized under Chapter 5 (commencing with Section 1010) of Title 14 of Part 2 of the Code of Civil Procedure except personal service, no later than 20 days prior to any hearing in which the genetic test results may be admitted into evidence. The genetic test results shall be accompanied by a declaration under penalty of perjury of the custodian of records or other qualified employee of the laboratory that conducted the genetic tests, stating in substance each of the following: (1) The declarant is the duly authorized custodian of the records or other qualified employee of the laboratory, and has authority to certify the records. (2) A statement which establishes in detail the chain of custody of all genetic samples collected, including the date on which the genetic sample was collected, the identity of each person from whom a genetic sample was collected, the identity of the person who performed or witnessed the collecting of the genetic samples and packaged them for transmission to the laboratory, the date on which the genetic samples were received by the laboratory, the identity of the person who unpacked the samples and forwarded them to the person who performed the laboratory analysis of the genetic sample, and the identification and qualifications of all persons who performed the laboratory analysis and published the results. (3) A statement which establishes that the procedures used by the laboratory to conduct the tests for which the test results are attached are used in the laboratory’s ordinary course of business to ensure accuracy and proper identification of genetic samples. Exhibit B Page 22 of 188 (4) The genetic test results were prepared at or near the time of completion of the genetic tests by personnel of the business qualified to perform genetic tests in the ordinary course of business. (b) The genetic test results shall be admitted into evidence at the hearing or trial to establish paternity, without the need for foundation testimony of authenticity and accuracy, unless a written objection to the genetic test results is filed with the court and served on all other parties, by any party no later than five days prior to the hearing or trial where paternity is at issue. (c) If a written objection is filed with the court and served on all parties within the time specified in subdivision (b), experts appointed by the court shall be called by the court as witnesses to testify to their findings and are subject to cross- examination by the parties. (d) If a genetic test reflects a paternity index of 100 or greater, the copy of the results mailed under subdivision (a) shall be accompanied with a voluntary declaration of paternity form, information prepared according to Section 7572. (Amended by Stats. 1999, Ch. 652, Sec. 7. Effective January 1, 2000.) 7553. (a) The compensation of each expert witness appointed by the court shall be fixed at a reasonable amount. It shall be paid as the court shall order. Except as provided in subdivision (b), the court may order that it be paid by the parties in the proportions and at the times the court prescribes, or that the proportion of any party be paid by the county, and that, after payment by the parties or the county or both, all or part or none of it be taxed as costs in the action or proceeding. (b) If the expert witness is appointed for the court’s needs, the compensation shall be paid by the court. (Amended by Stats. 2012, Ch. 470, Sec. 22. (AB 1529) Effective January 1, 2013.) 7554. (a) If the court finds that the conclusions of all the experts, as disclosed by the evidence based upon the tests, are that the alleged father is not the father of the child, the question of paternity shall be resolved accordingly. (b) If the experts disagree in their findings or conclusions, or if the tests show the probability of the alleged father’s paternity, the question, subject to Section 352 of the Evidence Code, shall be submitted upon all the evidence, including evidence based upon the tests. (Enacted by Stats. 1992, Ch. 162, Sec. 10. Operative January 1, 1994.) Exhibit B Page 23 of 188 7555. (a) There is a rebuttable presumption, affecting the burden of proof, of paternity, if the court finds that the paternity index, as calculated by the experts qualified as examiners of genetic markers, is 100 or greater. This presumption may be rebutted by a preponderance of the evidence. (b) As used in this section: (1) “Genetic markers” mean separate genes or complexes of genes identified as a result of genetic tests. (2) “Paternity index” means the commonly accepted indicator used for denoting the existence of paternity. It expresses the relative strength of the test results for and against paternity. The paternity index, computed using results of various paternity tests following accepted statistical principles, shall be in accordance with the method of expression accepted at the International Conference on Parentage Testing at Airlie House, Virginia, May 1982, sponsored by the American Association of Blood Banks. (Amended by Stats. 1997, Ch. 599, Sec. 39. Effective January 1, 1998.) 7556. This part applies to criminal actions subject to the following limitations and provisions: (a) An order for the tests shall be made only upon application of a party or on the court’s initiative. (b) The compensation of the experts, other than an expert witness appointed by the court for the court’s needs, shall be paid by the county under order of court. The compensation of an expert witness appointed for the court’s needs shall be paid by the court. (c) The court may direct a verdict of acquittal upon the conclusions of all the experts under Section 7554; otherwise, the case shall be submitted for determination upon all the evidence. (Amended by Stats. 2012, Ch. 470, Sec. 23. (AB 1529) Effective January 1, 2013.) 7557. Nothing in this part prevents a party to an action or proceeding from producing other expert evidence on the matter covered by this part; but, where other expert witnesses are called by a party to the action or proceeding, their fees shall be paid by the party calling them and only ordinary witness fees shall be taxed as costs in the action or proceeding. (Enacted by Stats. 1992, Ch. 162, Sec. 10. Operative January 1, 1994.) Exhibit B Page 24 of 188 7558. (a) This section applies only to cases where support enforcement services are being provided by the local child support agency pursuant to Section 17400. (b) In any civil action or proceeding in which paternity is a relevant fact, and in which the issue of paternity is contested, the local child support agency may issue an administrative order requiring the mother, child, and the alleged father to submit to genetic testing if any of the following conditions exist: (1) The person alleging paternity has signed a statement under penalty of perjury that sets forth facts that establish a reasonable possibility of the requisite sexual conduct between the mother and the alleged father. (2) The person denying paternity has signed a statement under penalty of perjury that sets forth facts that establish a reasonable possibility of the nonexistence of the requisite sexual contact between the parties. (3) The alleged father has filed an answer in the action or proceeding in which paternity is a relevant fact and has requested that genetic tests be performed. (4) The mother and the alleged father agree in writing to submit to genetic tests. (c) Notwithstanding subdivision (b), the local child support agency may not order an individual to submit to genetic tests if the individual has been found to have good cause for failure to cooperate in the determination of paternity pursuant to Section 11477 of the Welfare and Institutions Code. (d) The local child support agency shall pay the costs of any genetic tests that are ordered under subdivision (b), subject to the county obtaining a court order for reimbursement from the alleged father if paternity is established under Section 7553. (e) Nothing in this section prohibits any person who has been ordered by the local child support agency to submit to genetic tests pursuant to this section from filing a notice of motion with the court in the action or proceeding in which paternity is a relevant fact seeking relief from the local child support agency’s order to submit to genetic tests. In that event, the court shall resolve the issue of whether genetic tests should be ordered as provided in Section 7551. If any person refuses to submit to the tests after receipt of the administrative order pursuant to this section and fails to seek relief from the court from the administrative order either prior to the scheduled tests or within 10 days after the tests are scheduled, the court may resolve the question of paternity against that person or enforce the administrative order if the rights of others or the interest of justice so require. Except as provided in subdivision (c), a person’s refusal to submit to tests ordered by the local child support agency is admissible in evidence in Exhibit B Page 25 of 188 any proceeding to determine paternity if a notice of motion is not filed within the timeframes specified in this subdivision. (f) If the original test result creates a rebuttable presumption of paternity under Section 7555 and the result is contested, the local child support agency shall order an additional test only upon request and advance payment of the contestant. (Amended by Stats. 2000, Ch. 808, Sec. 72. Effective September 28, 2000.) Exhibit B Page 26 of 188 COUNTY OF FRESNO ADDENDUM NUMBER: ONE (1) RFQ NUMBER: 18-058 DNA - PATERNITY TESTING SERVICES Issue Date: July 19, 2018 CLOSING DATE:AUGUST 15, 2018 AT 2:00 P.M. Submit all Questions and Quotations on the Bid Page at Public Purchase. For assistance contact Darren Howard at (559) 600-7110. NOTE THE FOLLOWING AND ATTACHED ADDITIONS, DELETIONS AND/OR CHANGES TO THE REQUIREMENTS OF REQUEST FOR QUOTATION NUMBER: 18-058 AND INCLUDE THEM IN YOUR RESPONSE. PLEASE SIGN AND RETURN THIS ADDENDUM WITH YOUR QUOTATION. ¾Delete page 20 (Checklist) of the RFQ and replace with the Revised Checklist. ¾Questions and Answers. ACKNOWLEDGMENT OF ADDENDUM NUMBER ONE (1) TO RFQ 18-058 COMPANY NAME: (PRINT) SIGNATURE: NAME & TITLE: (PRINT) Purchasing Use:DH:st ORG/Requisition: 5110 / 5111800064 Exhibit B Page 27 of 188 QUESTIONS AND ANSWERS Q1. Can the vendor conference on July 24th be attended via telephone, or must a representative appear in person? A1. Vendors have the option of joining the meeting by phone using the following information: Bidders are to contact Darren Howard at (559) 600-7110 or countypurchasing@fresnocountyca.gov to receive a Skype invitation to the conference call. Skype for Business Meeting: Date: July 24, 2018 at 10:00 AM Pacific Conference Call # (559)-600-9870 Conference ID: 6602349 (Skype for Business is not required to participate. The link provided in the emailed invitation will open Skype for Business in any web browser or bidders can dial in with conference number and ID.) Q2. The submittal requirements listed on page 15 of the RFQ are clear; however, the checklist provided on page 20 seems to lack elements of the proposal that need to be included; i.e. the Comply/Not Comply list (pages 17-18), list of subcontractors (page 10), etc. It also does not indicate an exact order in which items are to be submitted. Can the County provide a comprehensive checklist indicating the exact order in which the submittals are to be provided in the RFQ response? A2. See the Revised Checklist Exhibit B Page 28 of 188 REVISED CHECK LIST This Checklist is provided to assist the vendors in the preparation of their bid response. Included in this list, are important requirements and is the responsibility of the bidder to submit with the bid package in order to make the bid compliant. Because this checklist is just a guideline, the bidder must read and comply with the bid in its entirety. Check off each of the following: 1.The Request for Quotation (RFQ) has been signed and completed. 2.Addenda, if any, have been signed and included in the bid package. 3.Subcontractors page as provided with this RFQ. 4.The Participation page as provided within this RFQ has been signed and included 5.The completed Reference List as provided with this RFQ. 6.The completed Comply/Not Comply as provided within this RFQ. 7.The Quotation Schedule as provided with this RFQ has been completed, price reviewed for accuracy and any corrections initialed. 8.Indicate all of bidder exceptions to the County’s requirements, conditions and specifications as stated within this RFQ. 9.Bidder to Complete page as provided with this RFQ. 10.Response to Submittal Requirements. 11.Return checklist with RFQ response. 12.Completed RFQ in pdf format, electronically submitted to the Bid Page on Public Purchase. Exhibit B Page 29 of 188 COUNTY OF FRESNO ADDENDUM NUMBER: TWO (2) RFQ NUMBER: 18-058 DNA - PATERNITY TESTING SERVICES Issue Date: August 1, 2018 CLOSING DATE:AUGUST 15, 2018 AT 2:00 P.M. Submit all Questions and Quotations on the Bid Page at Public Purchase. For assistance contact Darren Howard at (559) 600-7110. NOTE THE FOLLOWING ADDITIONS, DELETIONS AND/OR CHANGES TO THE REQUIREMENTS OF REQUEST FOR QUOTATION NUMBER: 18-058 AND INCLUDE THEM IN YOUR RESPONSE. PLEASE SIGN AND RETURN THIS ADDENDUM WITH YOUR QUOTATION. ¾Questions and Answers. ACKNOWLEDGMENT OF ADDENDUM NUMBER TWO (2) TO RFQ 18-058 COMPANY NAME: (PRINT) SIGNATURE: NAME & TITLE: (PRINT) Purchasing Use:DH:st ORG/Requisition: 5110 / 5111800064 Exhibit B Page 30 of 188 QUESTIONS AND ANSWERS Q1.Is the testing volume 100 samples for each department, or 100 samples combined? A1. The average is 100 samples combined for both departments. Q2.Please clarify item #14 of the Comply/Not Comply section. The charges per individual are listed separately. Should this be an all-inclusive cost? A2. Yes. Q3.If testing is done outside of Fresno County, could this be an additional charge? A3. Yes. Any additional fees would need to be noted in the Quotation Schedule. Q4.Regarding item #7 of the Comply/Not Comply section, how does the contractor ensure consent? A4. If swabbed in Fresno County, DCSS will handle the scheduling and coordination with the parties. If the non-custodial party is incarcerated, a court order is required in order to test. DCSS will also handle scheduling and coordination in these situations. The Contractor should require a statement of consent for the individual to sign when tested. If the mother or alleged father is a minor, a guardian or custodian’s consent and signature is required. Q5.With regard to the revised checklist provided in Addendum #1, please clarify if Items #1 and #9 are the same; i.e. the completed and signed cover page of the RFQ document. A5. Item #1 and #9 of the Revised Check List are both referencing the RFQ Cover Page. Exhibit B Page 31 of 188 Exhibit B Page 32 of 188 Exhibit B Page 33 of 188 Exhibit B Page 34 of 188 Exhibit B Page 35 of 188 Exhibit B Page 36 of 188 VENDOR MUST COMPLETE AND RETURN WITH REQUEST FOR QUOTATION. Firm: REFERENCE LIST Provide a list of at least five (5) customers for whom you have recently provided similar products/services. If you have held a contract for similar services with the County of Fresno within the past seven (7) years, list the County as one of your customers. Please list the person most familiar with your contract. Be sure to include all requested information. Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Failure to provide a list of at least five (5) customers may be cause for rejection of this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xhibit B Page 37 of 188 VENDOR MUST COMPLETE AND RETURN WITH REQUEST FOR QUOTATION. Firm: REFERENCE LIST Provide a list of at least five (5) customers for whom you have recently provided similar products/services. If you have held a contract for similar services with the County of Fresno within the past seven (7) years, list the County as one of your customers. Please list the person most familiar with your contract. Be sure to include all requested information. Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Reference Name: Contact: Address: City: State: Zip: Phone No.: ( ) Date: Service Provided: Failure to provide a list of at least five (5) customers may be cause for rejection of this RFQ. (FOFUJDQBUFSOJUZUFTUJOHTFSWJDFT (FOFUJDQBUFSOJUZUFTUJOHTFSWJDFT (FOFUJDQBUFSOJUZUFTUJOHTFSWJDFT (FOFUJDQBUFSOJUZUFTUJOHTFSWJDFT (FOFUJDQBUFSOJUZUFTUJOHTFSWJDFT 4UBUFPG5FOOFTTFF  3PCFSU%VDL %FBEFSJDL4U /BTIWJMMF 5/       QSFTFOU 4UBUFPG5FYBT /FDJB8BUTPO &0MUPSG "VTUJO 59       QSFTFOU 4UBUFPG'MPSJEB   $ISJT#VUUFSXPSUI 4IVNBSE0BL#MWE #MEH 3PPN 5BMMBIBTTFF'-        QSFTFOU 4UBUFPG-PVJTJBOB  -ZEJB4DBMFT /'PVSUI4U #BUPO3PVHF -"       QSFTFOU 4UBUFPG.JTTJTTJQQJ  -ZOETZ-BOESZ*SXJO /4UBUF4U UI'MPPS +BDLTPO .4       QSFTFOU %/"%JBHOPTUJDT$FOUFS *OD Exhibit B Page 38 of 188 Exhibit B Page 39 of 188 Exhibit B Page 40 of 188 QUOTATION SCHEDULE Testing with buccal swabs $ per person Testing with blood samples $ per person Additional testing required to reach a paternity index of 100 $ per person Consultation by laboratory with other laboratories to confirm unusual or uncertain results $ per person Drawing and identification fee (Fresno County area) $ per person Drawing and identification fee (outside Fresno County) $ per person Expert witness fee (court or deposition time) $ per person Retesting requested by laboratory $ per person Miscellaneous expense (define) $ per person         /" Exhibit B Page 41 of 188 EXCEPTIONS DNA Diagnostics Center, Inc. does not note any exceptions to the requirements and conditions of the Request for Quotation No. 18-058 and will meet or exceed all contractual terms and conditions as specified. Exhibit B Page 42 of 188 Exhibit B Page 43 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 1 of 45 DNA DIAGNOSTICS CENTER, INC. PROPOSAL TO PROVIDE GENETIC PATERNITY TESTING SERVICES SUBMITTAL REQUIREMENTS All bidders shall provide sufficient information to enable a complete evaluation of the laboratory’s technical approach, project personnel, management operations, corporate experience, and pricing. Pursuant to instructions included in this RFQ, Scope of Work and Submittal Requirements, bidders shall include a response to the following: 1. Bids shall include a discussion of the proposed technical approach and a summary of the laboratory’s specific testing experience and include any experience with governmental entities listing unit and location. Response: As the incumbent provider of genetic paternity testing services to Fresno County, DDC will continue to utilize the following technical and administrative approach and methodology for management of this contract: Client Scheduling DDC will continue to schedule client appointments upon receipt of referrals and will return the applicable information to the County within two business days of receiving the request. DDC will also provide notification to the DCSS and DSS of missed appointments and will reschedule them at no additional charge. Intergovernmental/UIFSA scheduling is conducted via our secure web portal application: (https://contracts.dnacenter.com) called DDC Direct Connect. DDC will continue to work with Fresno County to accommodate any special scheduling requests. Specimen Collection DDC will continue to provide specimen collectors who are trained, professional, and proficient at sample collection to collect buccal swab and/or blood specimens at the Fresno County Courthouse and at other collection sites throughout the State of California, the United States, and internationally. DDC also provides its clients with prompt response in emergency situations through its Specimen Collection Network, which is dedicated to the implementation and management of all specimen collectors and collection sites we utilize. DDC provides specimen collectors with all necessary supplies for collecting specimens. DDC closely monitors Fresno County collection personnel and has always ensured coverage at the courthouse, county jail, and other off-site facilities. DDC also responds quickly to emergency situations and has accommodated requests for additional collectors or urgent collections on short notice. DDC’s Specimen Collection Network ensures that the collection site is always staffed with competent and efficient collection personnel that will ensure customer satisfaction in Fresno County. Exhibit B Page 44 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 2 of 45 Maintenance of Chain of Custody Documentation DDC’s comprehensive processes ensure an intact, legally admissible chain of custody that will meet the requirements of the State of California and are in compliance with the directives of Fresno County. All DDC chain of custody procedures meet or exceed the requirements established by the AABB. DDC is responsible for maintaining chain of custody throughout all phases of the testing process from specimen collection through storage and archiving of case files and samples. DDC handles all samples in such a manner to ensure that they will not be contaminated, tampered with, or substituted. Chain of custody procedures are also described in detail in DDC’s Sample Collection Manual which will be provided upon request. Specimen Collection According to the Process Control Section 5.0 of the Standards for Relationship Testing Laboratories published by the AABB, the following guidelines apply to sample collection and are strictly adhered to by DDC: • The laboratory obtains informed consent for all participating individuals to indicate they had knowledge of and granted consent for the test. At the time of specimen collection, DDC’s specimen collectors require consent in the form of a court order or written authorization (signature) from the tested party. • The collection is performed and witnessed by a competent person that has no interest in the testing outcome. DDC’s specimen collectors act as witnesses to the sample collection process, and their name and contact information become part of the laboratory’s permanent record. • The person performing the collection will confirm the identity of the person tested and record the stated family relationship. The specimen collector is required to obtain government-issued photo identification of the parties collected to ensure that the sample is collected from the appropriate individual, or in the case of a minor child, obtaining written parental or guardian consent. If a minor child is being collected, a parent or legal guardian must sign the chain of custody form indicating their relationship to the minor child and provide documentation of that relationship. • In addition, the collected party must initial the swab packet to verify that the label on the specimen is accurate, and all specimens are sealed in tamper-proof packaging prior to shipment to DDC’s laboratory. • The following information is obtained and recorded for each sample collected: name, alleged relationship, race/ethnic background (of mother and alleged father), date of birth, place and date of sample collection, signature, record of identification number from the government-issued photo identification, thumbprint, and a photograph is taken of the positively identified individual. Photos must be sufficiently clear to identify the Exhibit B Page 45 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 3 of 45 individual(s) in the photograph. Individuals will be asked to remove hats, sunglasses, scarves, or anything else that would obscure their facial features. • DDC requires that all of this information be obtained and recorded on the Client Identification/Chain of Custody form. The chain of custody form is completed with all required information and adult parties are asked to verify the accuracy of all information prior to sample collection. DDC’s chain of custody documentation has been introduced and readily accepted without challenge as an item of evidence in many paternity hearings across the country. The photographs and thumbprints are obtained and samples are placed in a tamper-proof envelope before forwarding to DDC’s testing laboratory. DDC requires witnessed client signatures on all chain of custody forms as well as client initials on swab envelopes, thus verifying correct labeling information. For buccal swab collections, swabs are inserted into color-coded envelopes to protect against the possibility of switching samples: blue envelopes are utilized for alleged fathers; pink envelopes for mothers; and yellow envelopes for child(ren). Specimen envelopes are never pre-labeled. Four (4) swabs are collected for each individual to be tested. A minimum of two (2) swabs are routinely used for the initial testing, and the remaining swabs are stored intact in the event additional testing is required in the future. Transportation of Specimens Specimen collectors package all collected samples and chain of custody documentation in a tamper resistant plastic sleeve, sealed with evidence tape, and then packaged in another tamper-resistant courier package for shipment to DDC’s laboratory. DDC has contracts with national overnight courier services (i.e. Federal Express, UPS) for the shipment of specimens to its laboratories, thus ensuring that specimens arrive promptly and securely at the laboratory. DDC will continue to assume all transportation costs. Laboratory Upon receipt at the laboratory, samples and chain of custody documents are examined for accuracy and completeness. The integrity of sample shipping containers is verified to ensure that no tampering has occurred between the time of sample collection and the time the package arrives at the laboratory. The accessioning technician signs and dates the chain of custody as an affirmation that the form is complete and that all samples were correctly labeled and received intact. If the integrity of the packaging has been compromised, the DCSS/DSS will be notified and an additional sample requested. When samples are deemed acceptable for testing, the samples and chain of custody are assigned a bar code with a unique numerical identifier, logged into DDC’s Laboratory Information Management System (LIMS), and the corresponding client data is entered. The Exhibit B Page 46 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 4 of 45 courier tracking number is scanned and recorded in LIMS for each sample that is received. All entry of client data must pass a quality audit prior to samples being processed in the laboratory. This process involves a system-driven required concordance check for duplicate entry to ensure samples meet all acceptance criteria and to confirm accurate data entry for spelling of names, dates of birth, etc. Samples are then submitted to the laboratory for processing. DDC utilizes automated processes and equipment whenever possible. By using sophisticated robotic sample handling equipment, the potential for human error in manipulating the layout and placement of samples during the testing process is greatly reduced. DDC continually evaluates existing processes and incorporates advances in technology in order to aid in efficiency, streamline processes, and eliminate human error. Final case review by DDC’s doctoral staff ensures technical and scientific accuracy of paternity test reports. Client names, collection dates, race, case numbers, and unique specimen bar code identifiers are all verified against the information on the chain of custody form as part of this final review. After the results have been issued, all samples and records are stored according to AABB prescribed procedures. There is complete documentation for each case processed which includes the individuals involved in collecting the samples, courier tracking number, accessioning the samples, testing the samples, data analysis, final review, and storage/archiving. Thus an intact chain of custody from initial specimen collection is created and these records will be maintained for a minimum of seven (7) years or longer if specifically requested to meet AABB and Fresno County contractual requirements. Coordination of Intergovernmental Paternity Testing DDC’s Scheduling Department will continue to coordinate the efficient and timely collection of Intergovernmental/UIFSA and international samples using an extensive network of over four thousand five hundred (4,500) collectors and collection sites. The expansive collection site network enables timely, efficient, and convenient global specimen collection services. In 2017 alone, DDC coordinated specimen collection appointments for well over forty thousand (40,000) cases for interstate, institutional/incarcerated, international, and intrastate testing parties. These sites include: child support agencies, correctional facilities, clinical laboratories, hospitals, clinics, physicians, and health departments. Qualified specimen collectors will perform all interstate and international sample collections according to current AABB standards. DDC will also coordinate the collection of specimens from parties who are in the military or are incarcerated. For an individual requiring an interstate or international specimen collection, DDC will be responsible for coordinating all aspects of the collection. This includes, but is not limited to: scheduling the collection and following up to ensure that samples reach the laboratory and are analyzed and reported in a timely manner. DDC’s dedicated Scheduling Department’s primary function is to schedule interstate, intrastate, international, and institutional collections. As a whole, this group has many years of combined experience providing these services to clients, and has extensive experience with the coordination and scheduling of Exhibit B Page 47 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 5 of 45 long-arm and absent party collections. They are familiar with the challenges of coordinating collections and ensure that arrangements are made regardless of area logistics. They are sensitive to special circumstances and will make arrangements to accommodate the needs of the customer. All intrastate, interstate, and institutional collections generally have confirmed appointments within twenty-four (24) to forty-eight (48) hours after receiving the request. DDC is committed to maintaining these metrics over the term of this contract. DDC believes the County realizes significant financial benefits by accelerating paternity establishment and reducing the time many cases require TANF support. DDC’s secure, on-line scheduling tool is typically the most efficient, accurate, and convenient way to schedule appointments. This tool alleviates the need for the caseworkers to re-enter contact or account information, increases communication accuracy, and can be accessed twenty-four (24) hours per day, seven (7) days per week. DDC’s web-based system for scheduling streamlines the ordering process for our customers. The site is accessed through https://contracts.dnacenter.com with the secure User ID and password set by each user. This process pre-populates customer data and notifies customers of schedules via e- mail, thus reducing request completion time and eliminating the inefficiencies that typically accompany a paper-based process. When DDC receives an electronic scheduling request, we will locate a collection site convenient and accommodating to the absent party. The collection site will be equipped to perform court-legal DNA collections under strict chain of custody procedures. A date and time will be established within fifteen to twenty (15-20) working days depending upon the needs of the agency to allow the DCSS/DSS sufficient time to notify the absent party. The confirmed appointment with the client names, case numbers, and collection site information is emailed back to the DCSS/DSS representative. A collection kit with complete instructions, chain of custody, and prepaid shipping materials will promptly be forwarded to the collection site. DDC includes complete buccal swab collection instructions in each specimen collection kit that is dispatched for an interstate, intrastate, institutional, or international collection. DDC will require that proper photo identification is presented at the time of specimen collection and that all other chain of custody protocols are followed. Adult parties will be required to provide government-issued photo identification. After the specimen collector verifies the identification, the identification number is recorded on the chain of custody form along with the tested party’s date of birth. DDC will ensure that no clients are collected without proper identification. Upon receipt of a request to collect a specimen from an incarcerated party, DDC’s Scheduling Department will contact the institution to determine their site-specific procedures. DDC’s Scheduling Department will work with the appropriate institution personnel and will collect the sample within a timely manner. If a specimen collector is not Exhibit B Page 48 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 6 of 45 permitted access to a particular facility, DDC will provide a specimen collection kit and complete instructions to the institution so that their personnel can perform the collection. DDC maintains the same stringent specimen collection procedures for parties who are incarcerated as for any other collection (i.e., intergovernmental and local collections), including requirements for photographs (where permitted) and thumbprints. Every year, DDC performs thousands of collections at prison facilities throughout the United States. DDC will also assist in the coordination of the release of tissue and/or blood specimens from deceased parties when requested by Fresno County. Regarding collections for active military personnel, DDC’s Scheduling Associate will send a copy of the court order or test request form, letter and specimen collection kit (complete with shipping supplies and instructions) to the military installation’s Commanding Officer. Buccal swab specimens are collected by medical personnel at the infirmary or military hospital and are forwarded to DDC’s laboratory for analysis. For international collections, DDC’s Scheduling Associate will contact the U.S. Embassy in the foreign country in question to discuss options for collecting a specimen. In general, hospital or clinical facilities are utilized, and DDC will forward all appropriate paperwork and a specimen collection kit to the designated site in order to facilitate collection. In addition, due to the prevalence of the use of buccal swabs, the collection and international shipment of this type of specimen is non-problematic, and even if there are unforeseen delays in customs or during shipment, degradation of the specimen is not a concern. DDC will make every effort to coordinate intergovernmental scheduling in a manner that maximizes the efficiency of specimen collections and ensures that all specimens required to complete a case arrive at the laboratory at approximately the same time. DDC will also provide notification of missed appointments and will reschedule them at no additional charge. To date, DDC has successfully managed well over two hundred seventy-five thousand (275,000) absent party collections. Laboratory Testing Protocols The ability to perform scientifically valid genetic testing that conforms to industry guidelines and the ability to defend its results in court if necessary are essential in the execution of this contract. DDC is committed to providing every client with accurate, thorough, and expedient paternity test results. DDC provides its clients with DNA testing performed using PCR (Polymerase Chain Reaction) technology and STR (Short Tandem Repeat) markers for routine analysis. DDC has been using STR technology since 1997, having conducted testing on over nine million five hundred fifty thousand (9,500,000) samples to date. This technology is approved by the AABB and is by far the most prevalent DNA testing methodology currently in use by AABB accredited laboratories. All STR markers employed by DDC for its routine parentage testing are commercially available, and their performance characteristics are well understood, reproducible, validated, and accepted by the scientific and legal communities. DDC will utilize either the Promega Exhibit B Page 49 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 7 of 45 Fusion Kit or Life Technologies Global Filer Kit as the initial routine testing battery. Both of these kits are fully validated and offer twenty-four (24) loci that are common and informative allowing for greater discriminatory power than many other testing batteries. Additionally, they have rapid thermal cycling protocols, which results in reduced turnaround times and enables the focus of the laboratory to be on more value added activities. When necessary, DDC has additional systems that will be used for extended testing. In total, DDC has thirty- six (36) validated and commercially available STR systems (including Amelogenin) which will be deployed as necessary to ensure that tests completed for the Fresno County DCSS/DSS will achieve a guaranteed minimum probability of paternity of 99.999% for standard cases though the majority of standard cases will have an average probability of paternity of 99.999999% or average combined paternity index of one billion to one (1,000,000,000:1). The available STR markers are identified in the table below: D3S1358 D8S1179 D18S51 CSF1P0 D13S317 D5S818 D21S11 TP0X FGA F13B D7S820 D16S539 LPL TH01 vWA Penta E Penta D D2S1338 D19S433 Amelogenin F13A01 FESFPS Penta C D8S1115 D6S474 D22S1045 D2S441 SE33 D10S1248 D9S1122 D17S1301 D9S2157 D3S4529 D14S1434 D1S1656 D12S391 Dual Process™ DDC was commended by the AABB in 2004 for being the first laboratory to truly offer double blind testing. DNA Diagnostics Center is the only DNA testing laboratory that performs every test twice, testing every genetic system in duplicate, not just exclusions, and not just a subset of the genetic markers. Our Dual Processing™ procedures ensure that each sample is tested in duplicate by two different teams working independently. Results from the two groups are compared upon completion of the analysis and must be in agreement for validation of the testing. This expensive and labor-intensive process is the most effective quality assurance program that ensures our testing is of the highest reliability and accuracy. This Dual Process™ is voluntary and far exceeds the industry standard. Every sample is independently logged-in, extracted, processed, and all genetic systems are analyzed twice by two separate teams. The two sets of results are reviewed by at least two DNA experts prior to a final review by a Ph.D. Director. Other laboratories provide duplicate testing, yet they only perform this testing on fewer than five (5) genetic markers. To the best of our knowledge, DDC is the only laboratory that performs duplicate testing on all genetic marker systems that are analyzed. This double blind testing on each sample ensures rapid turnaround times because there is no delay in repeating excluded alleged fathers. The standard battery and the additional validated systems will easily result in meeting the expected probabilities of paternity for alleged father inclusions and a minimum of four exclusions for alleged fathers that are not the biological father. Fresno County will continue to have a high level of confidence that the correct samples were tested and reported. Exhibit B Page 50 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 8 of 45 Retention of Specimens and Case File Documentation All records and samples are maintained at the laboratory according to AABB protocols and industry standards. All biological specimens (i.e. blood and cheek swabs) for routine testing are kept in the laboratory until testing is complete. All cheek swab samples are stored at room temperature and all blood samples are stored at 1-6°C. Case records will be maintained for a minimum of seven (7) years or longer if specifically requested to meet AABB and Fresno County contractual requirements. All case file records are stored electronically to facilitate rapid information retrieval. Utilization of Previously Tested Samples As the incumbent provider of genetic paternity testing services to Fresno County since 2012, DDC has developed an efficient process to manage the coordination of reusing samples/data for previously tested parties. Due to the volume and stipulation to utilize prior samples (when requested) in Fresno County, there is a significant volume of cases where DDC is being requested to use a previously tested party in a subsequent case. DDC’s quality processes ensure that the correct parties are identified and matched prior to the commencement of testing. The retest authorization is submitted to DDC and processed when the remaining parties are received. If a party was previously tested and invoiced, DDC will not invoice for that party again. This demonstrates significant savings to Fresno County. This process of reuse saves the County hundreds of dollars annually. Genetic Testing Experience DDC is one of the world’s largest and most experienced private DNA testing laboratories. Our laboratory was incorporated in the State of Ohio in 1994. In 1995, the Center moved to the current location and was renamed DNA Diagnostics Center (DDC). In 2015, DDC became a wholly owned subsidiary of DDC-DNA Holdings, Inc. DDC has been providing quality genetic testing services for twenty-three (23) years to customers throughout the world. As one of the nation’s largest family relationship testing providers, DDC has developed a reputation for exceptional quality and legendary customer service. Its highly accredited laboratory provides DNA testing services for both government agencies and private customers to resolve the parentage of children and determine other family relationships. DDC is a market leader for the determination of paternity testing not only in the United States but throughout the world. Over the past twenty-three (23) years, DDC has analyzed well over nine million five hundred fifty thousand (9,500,000) family relationship samples in all 50 states and over 173 countries demonstrating our broad experience both domestically and internationally, and we are dedicated to the business of genetic identity testing. Our laboratory facility and its personnel are fully qualified, competent, and capable of implementing and maintaining the requirements of this contract. Throughout DDC’s history and path to becoming a leading genetic testing services provider, we have retained the customer-oriented focus characteristic of a smaller organization. DDC prides itself in servicing accounts ranging from a limited number of samples to over 65,000 samples per year, and each customer is treated as a valued partner. This opinion is shared by our Exhibit B Page 51 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 9 of 45 customers and is confirmed through positive customer surveys and through the references that are included with this proposal. DDC offers comprehensive DNA testing services in several specialty areas: paternity and family relationship testing, forensics, and veterinary testing. DDC established the DNA Technology Park, a 7-acre campus located in Fairfield, Ohio, a suburb north of Cincinnati. DDC has state-of-the-art technology and instrumentation for performing DNA testing in this ultra-modern 66,000 square foot multiple building laboratory complex. The laboratory employs approximately 240 employees, comprised of management, laboratory staff, and customer service personnel dedicated solely to identity testing. Our twelve (12) Ph.D. scientists, together with our laboratory staff, have a combined experience level of more than three hundred fifty (350) years in DNA technology, paternity testing, forensic testing, and genetic studies. Additionally, DDC has multiple additional accredited satellite facilities located in Baltimore, Maryland; Minneapolis, Minnesota; Chicago, Illinois; Boston, Massachusetts; Ridgewood, New Jersey; Philadelphia, Pennsylvania; and Plantation, Florida. DDC’s laboratory facility in Fairfield, Ohio Exhibit B Page 52 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 10 of 45 Aerial View of DDC’s Campus in Fairfield, Ohio DDC’s Service Offerings: DDC provides a wide range of DNA testing services to individuals and organizations around the world. These include paternity and other family relationship testing, immigration testing, ancestry testing, forensics, and veterinary DNA testing. DDC’s scientists have the level of experience and depth of expertise required to solve difficult cases in each of these testing specialties. Additional information on all of DDC’s service offerings can be found on our website: www.dnacenter.com. Paternity and Family Relationship Testing DDC is one of the most experienced private providers of paternity and family relationship testing. DDC will report findings of either a conclusive exclusion (minimum of three (3) direct exclusions) or inclusion that exceeds the AABB’s minimum probability of paternity (greater than 99.0%; i.e. paternity index = 100). DDC’s testing battery provides a typical probability of paternity of 99.999999% (paternity index = 100,000,000) for standard cases. Our results are routinely recognized by courts and other government agencies in legal cases such as child support and Social Security benefit claims. In the absence of an alleged father, DDC can provide other testing options in order to help establish the child’s relationship including deceased sample testing, grandparentage testing, genetic reconstruction, and siblingship testing. Non-Invasive Prenatal Testing Available through DDC, this is one of the most accurate, non-invasive ways to establish paternity before a baby is born. The process is state-of-the-art, combining the latest in DNA SNP microarray technology and proprietary methods of preserving and analyzing the baby's DNA found naturally in the mother's bloodstream. Exhibit B Page 53 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 11 of 45 Immigration Testing Many clients use DDC’s DNA testing services to prove biological ties to a United States citizen who is sponsoring their immigration to the U.S. DDC’s immigration specialists know the specific DNA testing standards and procedures for each country, having provided testing to more than 900 agencies and governments in over 173 countries worldwide. Ancestry Testing Services DDC offers testing services to assist family historians, genealogists, and those interested in learning more about their heritage. DDC’s DNA Origins® testing analyzes 176 ancestry informative markers found throughout a person’s genome and calculates their relative bio-geographical ancestry as percentage values of European, Indigenous American, East Asian, and Sub-Saharan African. We also provide maternal mitochondrial lineage testing and paternal Y-STR lineage testing. Forensics DDC Forensics offers evidence screening, serological analysis, DNA testing, DNA expert testimony services, forensic paternity analysis, and DNA specimen matching services. We serve as a neutral laboratory providing accurate forensic DNA services and independent consultation to crime laboratories, law enforcement agencies, defense attorneys, and private investigators worldwide. DDC was honored at Ohio Innocence Project's (OIP) tenth Anniversary Gala, celebrating freedom for those exonerated and the organizations that have contributed to the effort. To date, DDC's testing for OIP includes more than 30 cases, resulting in the exonerations of Ohio residents, Robert Towler, Robert McClendon, and Dewey Jones. Working with other Innocence Projects on post-conviction cases throughout the United States, DDC has provided DNA testing that resulted in the exonerations of Florida citizens James Bains, Derrick Williams, and Cheydrick Britt, and Kentucky Innocence Project client, Kerry Porter. Veterinary DNA Testing DDC’s subsidiary, Veterinary Diagnostics Center, provides innovative, quality DNA testing to breeders, veterinarians, and pet owners for companion and sport animals. We perform DNA profile tests required to register canine species, parentage tests for dogs and cats, avian sex determination, and testing for genetic diseases in horses, dogs, and cats. As a fully licensed and accredited laboratory, all aspects of parentage testing performed at DDC are in strict compliance with or exceed the standards established by the AABB and its other accrediting agencies. DDC has proven it has the operational capacity, technical resources, and expertly qualified personnel required to manage the paternity genetic testing services contract for Fresno County, and we will continue to provide the highest quality services for the duration of this contract. Exhibit B Page 54 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 12 of 45 In addition to private testing, DDC currently holds state contracts for the performance of paternity testing for child support cases in the District of Columbia, Florida, Illinois, Kentucky, Michigan, Mississippi, Missouri, Nebraska, Ohio, Pennsylvania, Tennessee, Texas, and West Virginia. In addition, DDC performs genetic testing for county, local, and tribal child support offices in the states of Alabama, Alaska, California, Colorado, Idaho, Indiana, Kansas, Louisiana, Maine, Maryland, Minnesota, Montana, New Jersey, New Mexico, New York, North Dakota, Oklahoma, South Dakota, Washington, Wisconsin, and Wyoming. In the past four (4) years, DDC was awarded five (5) major statewide paternity contracts for Texas, Ohio, Kentucky, West Virginia, and Missouri, with Texas being the single largest statewide contract in the United States. DDC’s highly experienced team successfully transitioned and executed each project. Contract requirements were incorporated and DDC continues to meet the contract deliverables and provide excellent service levels. The table below and on the following page depicts the annual testing volumes for current DDC contracts and child support offices that DDC services: States Currently Serviced by DDC’s Government Contracts Division State Approximate Annual Sample Volume Alabama 7,500 California 7,500 Colorado 75 Florida 32,000 Illinois 14,500 Indiana 8,500 Kentucky 15,000 Louisiana 4,500 Michigan 22,000 Minnesota 5,000 Mississippi 15,000 Missouri 17,000 Nebraska 5,500 New Jersey 1,000 New Mexico 1,500 New York 7,000 Ohio 55,000 Pennsylvania 19,500 Tennessee 25,000 Texas 65,000 Tribal Native American 2,000 Washington DC 2,000 Exhibit B Page 55 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 13 of 45 West Virginia 5,000 Wisconsin 20,000 In addition, the following highlights DDC’s extensive experience in the field of genetic parentage testing: • In 2017, DDC’s laboratory provided results for over three hundred twenty-five thousand (325,000) family relationship cases performing genetic testing and analyzing test results for nearly eight hundred fifty thousand (850,000) individuals. • DDC provides contract services to state and county agencies for programs of only a few samples per year to accounts submitting over sixty-five thousand (65,000) samples per year. • DDC provides paternity testing services for the private sector as well. In 2017, DDC conducted testing for approximately five hundred thousand (500,000) samples for various private sector clients, including attorneys, corporations, immigration agencies, and private individuals. Nearly three out of every four private family relationship tests are performed by DDC, which is a testimonial to our well renowned, trusted, and reliable testing services. • DDC will perform DNA analysis exclusively and will provide results of conclusive exclusion or a typical probability of paternity of 99.999999% or higher for standard cases, which exceeds both the AABB standard and the specifications of this solicitation. • DDC will perform independent, confirmatory DNA analysis for all samples in all cases, not just exclusions, and not just excluded alleged fathers. • DDC has many years of experience working with Child Support programs nationwide, and is the current supplier of genetic testing services for Fresno County. • DDC will continue to provide highly skilled, experienced, reliable, and professional specimen collection services in Fresno County, throughout the entire state of California, as well as nationwide and worldwide. • DDC provides paternity testing using standard autosomal STR (Short Tandem Repeat) markers to resolve the vast majority of paternity analyses. DDC can also provide testing using Y-STRs (paternal lineage), and mitochondrial DNA testing (maternal lineage) as needed to resolve certain difficult cases. • DDC can extract DNA from many biological materials including standard cheek swabs and blood samples, as well as more complicated tissue, fingernail, bone, teeth, pathology, and hair samples. Exhibit B Page 56 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 14 of 45 • DDC can provide paternity testing in more complicated situations when the mother is not available or when the alleged father is deceased. DDC can conduct complex kinship tests to determine a biological relationship between relatives other than a father and child (i.e. grandparents, aunts/uncles, or siblings). • Test results will be furnished within a median approximate turnaround time of six (6) days after collection of the last specimen. During the course of our contract with Fresno County, DDC has successfully fulfilled the specified turnaround time requirement and has provided results to the DCSS/DSS with an approximate average turnaround time of six (6) calendar days. • In addition to our extensive scientific experience in the human identity testing field, DDC also has a strong customer service team. This includes trained specialists who exclusively schedule UIFSA, long arm, international, military, and prison draws, and a Customer Service Associate dedicated to serving the needs of Fresno County. • DDC’s PhD staff is actively involved in the AABB. DDC’s Chief Science Officer, Dr. Michael Baird has served as both a member and chair for the Relationship Testing Standards Committee for AABB as well as the Relationship Testing Accreditation Committee. He has also been a member of the Molecular Testing Committee. In addition, DDC’s Laboratory Director, Dr. Debra Davis, has been a member of the AABB since 1998, has been part of the AABB Assessor Program for Relationship Testing since 2007 and currently serves on the Relationship Testing Standards subcommittee. Dr. John Peterson, Laboratory Director, currently serves on the AABB Relationship testing accreditation subcommittee. • DDC is a member of and is involved with many national child support associations, including NCSEA, ERICSA, WICSEC, and numerous state child support associations. Being closely affiliated with these organizations keeps DDC informed about child support enforcement issues and programs. • DDC has extensive experience providing expert witness testimony services for courts and jurisdictions nationwide. • DDC has an excellent record in providing accurate invoicing and billing statements. Experience with State Title IV-D Programs State of Tennessee Department of Human Services In 2009, DDC was awarded the contract as a sole provider of genetic testing services for the State of Tennessee Department of Human Services. DDC provides paternity testing services to the Child Support Enforcement offices in all thirty-one (31) Judicial Districts across the state. The services provided include sample collection, laboratory testing, reporting, interstate, intrastate, and institutional party scheduling, expert testimony and statistical Exhibit B Page 57 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 15 of 45 reporting. The original contract term was for a period of five years. DDC was re-awarded the contract resulting from the RFP released in 2014. The current contract period runs until the end of March 2019. The Tennessee contract involves the analysis of approximately 25,000 samples annually. DDC provides specimen collection personnel at designated times and locations throughout the state. These offices have established schedules and DDC provides the specimen collection personnel. There are some areas where DDC is providing the site and the collector if the Child Support/Judicial District office is not available. DDC has also provided all training, documentation, and supplies needed for those offices that want to perform agency or staff collections. DDC provided this training at quarterly management meetings, in local Judicial District offices, and through web-based training platforms. Reports are issued to each designated Judicial District. The designated staff in each office access DDC Direct Connect for access to case status, to schedule interstate and institutional requests, review/print reports, and order supplies. The State of Tennessee contract also has a stipulation to use previously tested samples upon request. Designated staff submit requests to use a previously tested sample once the agency has the appropriate authorization to proceed. Once DDC receives the request, the case participants are matched and testing begins. Monthly Case Activity reports are provided to the State along with additional information as requested. DDC staff have participated and made presentations at state quarterly meetings. Michigan DHS, Office of Child Support DDC is the sole provider for paternity testing and related services to the State of Michigan. Services provided include specimen collection, intra and interstate scheduling, transportation, analytical testing, electronic result reporting, issuance of monthly statistical reports, and expert witness support. DDC developed and currently maintains a specimen collection schedule that is beneficial to the state from both logistical and economical standpoints. In Wayne County (Detroit metropolitan area) alone, DDC routinely collects 150 samples on any given sample collection day. DDC has conducted self-collection training sessions for various child support offices, and many of the smaller counties in the northern region of the state perform self-collections. In addition, Michigan’s Expungement Statute, MCL722.716a, governs the destruction of specimens and isolated genomic DNA, data, and documentation related to excluded alleged fathers 90 days after the reporting of results. DDC must undergo annual audits to ensure compliance with the directives of the expungement regulation and has received satisfactory ratings for every audit conducted. The contract spans five years (2010 through 2015) with the option of two (2) two-year renewals (9-year total contract term through 2019). DDC analyzes and reports approximately 22,000 samples annually for the State of Michigan. Commonwealth of Pennsylvania, Bureau of Child Support Enforcement DDC started providing paternity testing services to various counties in the Commonwealth of Pennsylvania in 2003. Since 2012, DDC has provided the full spectrum of genetic testing services to all 67 counties within the Commonwealth of Pennsylvania. Services provided Exhibit B Page 58 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 16 of 45 include but are not limited to, appointment scheduling, sample collection and transportation, laboratory testing, issuing of fully electronic genetic test reports, invoicing, customer service, expert witness services, and performance tracking. DDC was re-awarded the contract resulting from the solicitation released in 2014. The current contract term is from November 2014 through October 2019. DDC analyzes and reports approximately 19,500 samples annually for the Commonwealth of Pennsylvania. Illinois Department of Healthcare and Family Services DDC is the sole provider of paternity testing in Title IV-D child support cases for the entire State of Illinois. DDC provides full services for paternity testing to include specimen collection and coordination, transportation, analytical testing, reporting, routine statistical reports, and expert witness testimony as required. One of the challenges of the Illinois contract is the mandated turnaround time of five (5) calendar days from the date of sample collection to the issuance of reports. DDC routinely and successfully reports the vast majority of cases within this specified turnaround time. The contract term is from 2011 through 2014 with two (two-year) renewal options, extending the contract until 2018. DDC was recently re-awarded the Illinois Contract. DDC analyzes and reports approximately 14,500 samples annually for the State of Illinois. Florida Department of Revenue DDC has been the sole provider of the complete spectrum of paternity testing services including, but not limited to, appointment scheduling, sample collection and transportation, laboratory testing, issuing genetic test reports, invoicing, customer service, expert witness services, and performance tracking to the State of Florida since December 2011 and was awarded the new contract that began in March 2013. DDC performs several special services to meet contract compliance. Annual volume reported for Florida is approximately 32,000 samples. The current contract extends from March 2013 through February 2016 with three one-year renewal options, extending the contract until 2019. The State of Florida contract has 2 components, one for testing and one for specimen collection. Under the existing contract, the DOR switched to having DOR agency/staff perform sample collections for all in-state parties collected at a DOR office. DDC developed a thorough training plan with the State to ensure that all staff met competencies in order to perform the collections. The transition to full DOR agency/staff collections was a complete success. DDC monitors the quality of the sample collection and reports any issues to the designated service center manager. Due to the quality of the training plan, issues are very rare. Staff are completing quality collections, and the DOR was able to extend the collection timeframes to better meet the needs of the customer. Samples are sent to DDC for testing. The designated DOR staff receive daily email alerts notifying them when results have been issued. The DOR is utilizing DDC’s Direct Connect secure portal to access all reports. Report copies are not mailed in hard copy format and are only provided electronically as requested by the DOR. Exhibit B Page 59 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 17 of 45 All interstate and institutional requests are submitted by authorized DOR staff through DDC Direct Connect. DDC conducts timely scheduling to ensure all contract requirements are met within the specified turnaround time. DDC coordinates collections at institutional facilities throughout the state and country for incarcerated individuals. DDC also schedules appointments for parties in interstate cases. All requests are monitored to ensure timely no- show notification if parties do not appear as scheduled. This information is provided back in an automated process on a daily basis to ensure the DOR is aware if a party missed an appointment. DDC also receives requests from the DOR to match up and test previously collected DOR samples once the DOR has authorization to proceed. Requests are submitted through DDC Direct Connect. Once DDC receives a request, the parties are matched and tested. DOR staff monitor DDC Direct Connect for case status, case reports, scheduling requests, and to search previously tested DOR parties. DDC provides Monthly Case Activity Reports as well as Quarterly reports. DDC has an excellent working relationship with the key contacts at the state level as well as staff at the local DOR service centers. State of Texas, Office of the Attorney General DDC was awarded the State of Texas contract in July 2014. The contract requires daily exchange of data between the OAG and DDC, and requires comprehensive reporting of collections, testing, and other statistical data. DDC successfully transitioned this contract from the previous vendor in addition to implementing a range of new IT requirements. Services provided under this contract were fully operational in January 2015. The contract has a term of five (5) years, ending in August 2019. The annual sample volume is approximately 65,000 samples. DDC worked with the OAG to implement the contract for a start date in December 2014. Due to the complexities and deliverables, there was a lengthy implementation phase. DDC provides a large network of Vendor (DDC) sites throughout the State of Texas. In addition, DDC also provides an equally large network of subcontracted specimen collectors that collect samples at designated courthouses throughout Texas. The OAG also conducts staff/agency self-collections in designated Child support office locations throughout the state. DDC developed all of the training protocols and conducted statewide training to OAG staff. Agency staff are successfully performing collections in offices throughout the state and submitting samples to DDC for testing. DDC conducted extensive OAG policy training to specimen collectors and vendor sites to ensure all contract requirements were met. DDC receives electronic referrals for all OAG cases. DDC staff review the detail to determine which cases require scheduling or other action. DDC completes scheduling for all interstate, incarcerated, and international parties requiring testing. Appointments are set within contract guidelines and for customer convenience. Due to the close proximity of Exhibit B Page 60 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 18 of 45 Texas to Mexico, DDC coordinates a large volume of international cases and has achieved great success. In addition to DDC company training, DDC staff and collectors have completed Texas required training regarding protection of sensitive personal and IRS information, customer service for external entities, discrimination and harassment, and fundamentals of family violence. DDC provides the OAG with several monthly case information reports using the data provided in the daily file, along with a Monthly Case Status summary. DDC presents quarterly statistics to the OAG contracts management team. DDC met every deliverable for implementation and successfully performs all requirements for this contract. State of Ohio, Department of Jobs and Family Services DDC has been a vendor for the state of Ohio since 2016 providing service to all eighty-eight (88) individual counties. Services provided include specimen collection, intra and interstate scheduling, transportation, analytical testing, reporting, issuance of monthly statistical reports and expert witness support. While the overall contract requirements are consistent within Ohio, each individual county does have unique reporting requirements. DDC has been able to customize its offering in order to meet these individual needs. Annual volume reported for Ohio is approximately 55,000 samples. The current contract extends until June 2018 with five one-year renewal options, extending the contract until 2023. State of Mississippi Department of Human Services Since 2012, DDC has provided paternity testing and all associated services for all 82 counties located in the State of Mississippi. This is another contract that initially came to DDC as a result of the transition in the Spring of 2012. This State had been working with the labs in the corporate lineage since 1990. After the initial two-year term (2012 through 2014), Mississippi issued its new RFP in the Spring of 2014. After success with DDC, the State of Mississippi awarded the new contract (July 1, 2014 through June 30, 2019) to DDC. Under the new contract, DDC helped Mississippi save a considerable amount of funds by transition from an old contract that utilized lab-furnished collectors at CSE offices and remote locations and implemented procedures where CSE associates have the clients swab themselves. DDC took an active role in the training of the collectors under the new procedures of the new contract. Like all other Child Support accounts, DDC provides the full spectrum of paternity testing services including, but not limited to, appointment scheduling, furnishing supplies for sample collection and transportation, laboratory testing, issuing genetic test reports, invoicing, customer service, online case management website, expert witness services, and performance tracking. Approximate annual sample volume: 15,000. Commonwealth of Kentucky, Cabinet for Health and Family Services Exhibit B Page 61 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 19 of 45 DDC was awarded the contract for the Commonwealth of Kentucky in June 2014. The start date was July 1, 2014, so there was a condensed implementation period. DDC was able to quickly provide trained, qualified specimen collection personnel in each of the 120 counties along with customer service and testing services starting July 1, 2014. DDC provides the full spectrum of paternity testing services including, but not limited to, appointment scheduling, sample collection and transportation, laboratory testing, issuing electronic genetic test reports, invoicing, customer service, expert witness services, and performance tracking. The designated child support staff receive daily email alerts notifying them when results have been issued. Kentucky is utilizing DDC’s Direct Connect secure portal to access all reports. Report copies are not mailed in hard copy format and are only provided electronically as requested by the CSE staff. The contract period extends for six (6) years through June 2020. The approximate annual sample volume for Kentucky is 15,000. Nebraska Health and Human Services, Child Support Unit DDC has been the sole provider of genetic testing services to the entire State of Nebraska since 2012. The current contract is effective until September 2014 with another six (6) years of renewal options extending to the year 2020. DDC provides the full spectrum of paternity testing services including, but not limited to, appointment scheduling, sample collection and transportation, laboratory testing, issuing genetic test reports, invoicing, customer service, expert witness services, and performance tracking. The approximate annual sample volume is 5,500. State of Missouri DDC was recently awarded the State of Missouri contract in October 2015, which had been held by the incumbent provider since 1992. The current contract is effective until September 2016 with another four (4) years of renewal options extending to the year 2020. DDC provides the full spectrum of paternity testing services including, but not limited to, appointment scheduling, sample collection and transportation, laboratory testing, issuing genetic test reports, invoicing, customer service, expert witness services, and performance tracking. The approximate annual sample volume is 17,000. Office of the Attorney General for the District of Columbia DDC was awarded the contract to perform parentage testing for Washington DC Child Support and the Superior Courts in November 2013. DDC provides the full spectrum of paternity testing services including, but not limited to, appointment scheduling, sample collection and transportation, laboratory testing, issuing genetic test reports, invoicing, customer service, expert witness services, and performance tracking. The contract spans one year with four one-year extensions, ending in November 2018 Annual testing volume is approximately 2,000 samples. Louisiana Department of Social Services, Office of Family Support DDC is one of two providers of genetic paternity testing services to the State of Louisiana. We have professionally managed the southern portion of this state contract since 2012. Services provided include but are not limited to, appointment scheduling, sample collection Exhibit B Page 62 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 20 of 45 and transportation, laboratory testing, issuing genetic test reports, invoicing, customer service, expert witness services, and performance tracking. DDC also provides specimen collection services at the parishes being serviced by DDC. Approximate annual sample volume is 4,500. DDC was recently awarded the new contract that resulted from the RFP process that began in January 2016 extending through 2018. This contract initially came to DDC in the Summer of 2012 after being with our corporate lineage (Orchid Cellmark and ReliaGene Technologies). Original testing services started in July 1992. After working with DDC through the remainder of the post-transition contract (2012-2015), the State of Louisiana selected DDC for a new contract term in 2015 (which runs through 12/31/2018). State of West Virginia DDC was recently awarded the contract to perform parentage testing for the State of West Virginia in August 2015. DDC provides the full spectrum of paternity testing services including, but not limited to, appointment scheduling, sample collection and transportation, laboratory testing, issuing genetic test reports, invoicing, customer service, expert witness services, and performance tracking. DDC provides a collection site and specimen collector for each of the 55 counties, per the contract requirements. DDC successfully implemented this project with a condensed timeline. The contract spans three years until August 2019. Annual testing volume is approximately 5,000 samples. 2. Provide your laboratory’s experience, performed under AABB accreditation, with California Child Support casework and trials. Response: DDC has a strong presence in the State of California and serves as the current provider of paternity testing services for Fresno County. In addition, DDC is a current provider of genetic parentage testing services to many jurisdictions throughout the State of California. The following listing depicts DDC’s experience providing DNA paternity testing services in California and cases within the State of California in which our doctoral staff has provided expert testimony services. Agua Caliente Band of Cahuilla Indians (ACBCI) 5401 Dinah Shore Dr. Palm Springs, CA 92264 Fresno County DCSS 2220 Tulare St., Suite 310P Fresno, CA 93721 Fresno County DSS 2011 Fresno St., Suite 105 Fresno, CA 93721 Exhibit B Page 63 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 21 of 45 Hoopa Valley Tribal Enrollment P.O. Box 1348 Hoopa, CA 95546 Lake County Child Support Enforcement 3980 Gard St. Kelseyville, CA 95451 Los Angeles County CSSD 5500 Southeastern Ave. Commerce, CA 90040 Plumas County Child Support Enforcement 522 Lawrence St. Quincy, CA 95971 San Francisco County DHS-CPS/HSA 170 Otis St. San Francisco, CA 94120 San Francisco County DCSS 617 Mission St. San Francisco, CA 94105 San Luis Obispo County Child Support Services 1200 Monterey St. San Luis Obispo, CA 93401 Expert Testimony in California: Dr. Michael Baird: • State of California vs W. Cathcart: 11/21/89 • State of California vs D. Harris: 12/14/89 • State of California vs C. Golden: 2/1/17 Dr. Debra Davis: • State of California vs. Gary Lee, 9/6/14 Dr. Julie Heinig: • State of California vs. T. Littlefield: 10/27/11 3. Contractor shall maintain an organizational structure and sufficient staff to administer and supervise all of the functions for which they are responsible under the terms of this RFQ and all applicable laws. Provide the names and resumes (curriculum vitae) of key Exhibit B Page 64 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 22 of 45 staff members. Response: As the incumbent provider of these services to Fresno County for the past six (6) years, DDC can ensure a seamless transition to the new contract with no interruption in service. All personnel currently assigned to perform duties under this contract with the County are already trained and qualified to properly execute the required scope of services. Thus, by selecting DDC to provide these services under the new contract, we can offer Fresno County seamless genetic testing services for the establishment of paternity. Unlike other laboratories that would require an extensive and cumbersome implementation period to establish their operations for the January 1 contract start date, DDC is prepared to continue to provide the County with superlative genetic testing services. DDC has proven over many years the ability to collect and analyze genetic material, work as a liaison between DCSS and DSS, exceed expectations for laboratory turnaround times, and provide accurate invoicing. Thus, there will be no risk in compromising the continuity of the Fresno County’s genetic testing workflow and operations. DDC will continue to maintain an organizational structure and sufficient staff to administer and supervise all of the functions and services that will be provided pursuant to this contract in accordance with all applicable laws, standards, and regulations. DDC is currently processing approximately 715,000 samples annually and has the analytical capacity to process more than 1,120,000 samples annually. DDC has more than sufficient capacity, technical, and administrative resources to continue to successfully manage the Fresno County contract. DDC is staffed with highly trained and qualified individuals dedicated to performing all of the technical and administrative areas related to paternity testing. Key Personnel: The caliber of DDC’s staff is outstanding, and our team is one of the most tenured, competent, and experienced in the industry. Many of DDC’s senior level staff have been employed with the company for more than a decade and have worked in the field of genetic testing for well over twenty years. Collectively, DDC’s key personnel and administrative support team represent over three hundred fifty (350) years of combined experience providing genetic family relationship testing services. All laboratory staff have passed extensive background clearance and are required to participate in internal and external training and proficiency programs and continuing education each year. These positions are considered key to contract implementation, facility operations, and the provision of services to Fresno County. The following section provides a brief bio for each individual, highlighting his/her responsibilities and experience. Detailed Curricula Vitae are provided as Attachment #1. Kathy Leis, Vice President, Operations Ms. Leis joined DDC in July 2012 after completing the oversight of the divestiture of Orchid Cellmark’s IV-D government paternity business. She was employed at Orchid Cellmark for over 27 years, with over 32 years of laboratory experience. She has a Bachelor of Science degree in Medical Technology and is certified by the American Society of Clinical Pathologists. She has been directly involved in all aspects of paternity testing and is well Exhibit B Page 65 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 23 of 45 versed in managing contracts. Ms. Leis not only has strong skill sets and experience in contract management, but also gained hands-on experience in all components of testing, including specimen collection and expert witness testimony as well as being intimately involved in quality processes. She has worked at the bench level in the laboratory, performed specimen collections, and has managed customer service. This allows her to better understand issues that arise in the field, as well as anticipate, prevent, and solve problems. Ms. Leis is responsible for overseeing the daily operations and for ensuring that both the laboratory and administrative operations meet or exceed the contractual requirements of Fresno County. She has extensive experience since the mid-1980’s working with Child Support, private industry and many other governmental agencies. She routinely participates in quarterly meetings to assess contract performance and is involved in all aspects of contract implementation and monitoring within the facility to ensure test results are issued accurately and in a timely manner. Other professional positions held include the following: Director of Operations, Orchid Cellmark (formerly GeneScreen), 1998-2012, Paternity Laboratory Supervisor and Technologist, Orchid GeneScreen, 1985-1997, Staff Medical Technologist, St. Luke’s Medical Center, 1984-1985, Staff Medical Technologist, Kettering Medical Center, 1981-1983 and Phlebotomist, Kettering Medical Center, 1979-1981. Michael Baird, Chief Scientific Officer Dr. Baird, DDC’s Laboratory Director and Chief Scientific Officer, has decades of experience in the field of DNA testing and has personally reviewed over 180,000 family relationship cases. In 1982, Dr. Baird was at the forefront of DNA testing as part of a team that pioneered identification through DNA and then offered it commercially. In 1987, he was the first DNA expert to testify in a U.S. court case and has since testified in hundreds of court cases involving DNA relationship testing and forensics. Dr. Baird has written and published numerous articles and manuscripts in the field of DNA technology, paternity testing, and forensics. Dr. Baird has appeared on several national TV shows that feature DNA testing. NBC News hired him as their on-air DNA expert during the OJ Simpson trial. He has also been interviewed on Larry King Live, Nancy Grace, Court TV, and others. Dr. Baird spent 7 years as Chairman of the Parentage Testing Accreditation Program Unit for the AABB. This organization oversees, sets rules and regulations, and accredits DNA paternity testing laboratories in the United States and abroad. Dr. Baird has continued to be an active member of the AABB. In January 2008, he was appointed by the AABB Board of Directors as Chair of the Relationship Testing Standards Program Unit. He was in charge of rewriting the Standards for Relationship Testing Laboratories, 9th Edition and the Guidance Document, which became effective in January 2010. He continues to maintain his position with the AABB. Dr. Baird is currently serving the AABB as the Chairman of the Paternity Accreditation Standards Committee. Dr. Baird also presides as the President of HITA, the Human Identity Trade Association. This organization is a nonprofit entity dedicated to advancing the human identity testing Exhibit B Page 66 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 24 of 45 industry and increasing public awareness of forensic and parentage DNA testing products and services. Led by Dr. Baird, our laboratory staff consists of twelve (12) PhD-level Directors and a staff of Bachelor-degreed technologists and technicians. We have a dedicated and experienced on- site Quality Assurance Manager, Dr. Todd Lewis, who oversees the laboratory’s quality system and conducts monthly internal audits. Our Laboratory Directors and professional staff have combined experience of over three hundred fifty (350) years in DNA technology, paternity testing, forensic testing, immunogenetics, and genetic studies. DDC’s laboratory staff has performed testing on over nine million five hundred thousand (9,500,000) genetic samples. The twelve (12) Laboratory Directors all hold doctorate degrees in biological and/or forensic science and are qualified experts to perform DNA biological relationship testing. All DDC Laboratory Directors perform data and case review, evaluation, and processing. Debra Davis, Ph.D., Laboratory Director Dr. Davis joined DDC in June 2012 and had been employed with Orchid Cellmark for over 13 years, serving as the Laboratory Director and previously as an Associate Laboratory Director. Dr. Davis assumed the role of Laboratory Director at Orchid Cellmark-Dayton in June 2007 and has more than 22 years of experience in the field of Molecular Genetics. She has a Ph.D. in Biomedical Sciences with a concentration in Molecular Genetics from Wright State University in Dayton, Ohio, an MBA in Finance, and a Bachelor of Science degree in Biology from the University of Cincinnati. She has over 6 years post-doctoral experience at the University of Cincinnati during which time she performed independent research using Polymerase Chain Reaction (PCR), Restriction Fragment Length Polymorphism (RFLP), cloning, and transgenic techniques. Dr. Davis is currently responsible for reviewing and interpreting test results, reviewing paternity case files, and providing technical assistance. Dr. Davis is fully qualified to direct AABB accredited testing for the purposes of relationship and identity determination, and over her career years has had the opportunity to review well over 233,000 family relationship cases. She received her Certificate of Qualification from the New York State Department of Health as a Laboratory Director for Parentage/Identity Testing in 2004. She received specialized Training in Basic Population Genetics and Forensic Statistics in 2003. She has been a member of the AABB since 1998, and has been part of the AABB Assessor Program for Relationship Testing since 2007. Dr. Davis has a strong commitment to all aspects of paternity and relationship testing, including assisting in the education and understanding of testing processes and outcomes. Dr. Davis is available to answer all questions that might arise involving paternity and relationship testing and also serves as an expert witness. Dr. Davis has testified in many diverse trials throughout the country. Dr. Davis has been an invited speaker at the Illinois Family Support Association’s Twentieth Annual Members’ Meeting and the Louisiana Exhibit B Page 67 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 25 of 45 Support Enforcement Association 2009 Training Conference Workshop. Further, Dr. Davis is thoroughly committed to advancing the education and advancement for youth and is a past member of the Ohio Biotech Prep Advisory Board and the Sinclair Community College Biotechnology Advisory Board located in Dayton, Ohio. In 2009, Dr. Davis provided training in relationship testing for both Medical Technologist Students from Wright State University, Dayton Ohio and Biotechnology tract students from Centerville High School, Centerville Ohio. Other professional positions held include: Postdoctoral Research Fellow, Division of Cardiology, University of Cincinnati Medical Center, 1996-1998, and Postdoctoral Research Assistant, Department of Internal Medicine, University of Cincinnati Medical Center, 1993- 1996. John Peterson, Ph.D., Laboratory Director Dr. Peterson has served as Laboratory Director and Assistant Laboratory Director at DDC for eleven (11) years. He received his Ph.D. in Biomedical Sciences, and his Bachelor of Science degree in Biological Sciences. Dr. Peterson is involved in final case review, as well as the review and interpretation of raw data for all paternity and relationship testing cases. He has personally evaluated over 410,000 family relationship cases. He also works closely with the Quality program to ensure that quality standards are met. Other professional positions held include: Forensic Scientist with the Marion County Forensic Services Agency in Indianapolis, Indiana (2007-2012) where he was responsible for the forensic analysis of DNA evidence and providing expert witness testimony. Dr. Peterson also serves as a DNA Auditor with National Forensic Science Technology Center. Dr. Peterson is a member of the AABB, the ASM (American Society for Microbiology), and the AAFS (American Academy of Forensic Sciences). Joy Johnson, Ph.D., Assistant Laboratory Director Dr. Johnson joined the DDC team as an Assistant Laboratory Director in 2012 after having been employed at Orchid Cellmark for over 12 years as an Associate Laboratory Director. Dr. Johnson’s graduate work in microbial genetics involved the creation and characterization of enzyme secretion mutants through DNA transformation and transposition studies. Her postdoctoral work, through the EPA, included studies with DNA characterization and hybridization studies of microbes capable of degrading components of Agent Orange. She was active in biotechnology professional groups and helped to establish a molecular biology laboratory. Dr. Johnson also participated in research for a period of time at the VA Medical Center including PCR analysis and oligonucleotide synthesis. She has also taught as an adjunct faculty member in the Biology Department at Sinclair Community College. Other professional positions held include: Research Associate, Wright State University, 1997-1999, and Research Microbiologist, Department of Veterans Affairs Medical Center, 1988-1997. Dr. Johnson has personally evaluated over 316,000 family relationship cases. Exhibit B Page 68 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 26 of 45 Dr. Yong Ji, M.D., Ph.D., Assistant Laboratory Director Dr. Ji recently joined DDC in 2014 as an Assistant Laboratory Director. She came to DDC with twenty-five (25) years of experience in scientific and medical research with twenty peer-reviewed scientific papers published in prestigious cardiovascular and physiology journals. She has twenty years of research experience with great achievements in the field of cardiovascular and lipid metabolism and strong technical skills covering the areas of molecular biology, biochemistry, and physiology, including gene manipulation, DNA, RNA analysis, kinetic analysis of enzyme, cell culture, Western blot assay of protein and protein phosphorylation, and a series physiological assays (e.g. cardiovascular and digestive function) in animal models. Dr. Ji is involved in final case review, as well as the review and interpretation of raw data for all paternity cases. Dr. Ji has personally evaluated over 108,000 family relationship cases. Dr. William Sun, Ph.D., Assistant Laboratory Director Dr. Sun recently joined DDC in 2015 as an Assistant Laboratory Director. Dr. Sun brings eighteen years of laboratory and research experience in molecular biology, having held positions in Canada, China, and now the United States. He earned his Ph.D. in Molecular Biology from the University of Alberta. Dr. Sun is involved in final case review, as well as the review and interpretation of raw data for all paternity cases. Dr. Sun has personally evaluated over 124,000 family relationship cases. Dr. Guangyun Sun, Ph.D., Assistant Laboratory Director Dr. Sun recently joined DDC in 2015 as an Assistant Laboratory Director. Dr. Sun brings over twenty years of laboratory and research experience in molecular genetics both in China and the United States. He earned his Ph.D. in Forensic Biology and Molecular Genetics from the West China University of Medical Science. He has co-authored over fifty scientific publications. Dr. Sun is involved in final case review, as well as the review and interpretation of raw data for all paternity cases. Dr. Sun has personally evaluated over 126,000 family relationship cases. Dr. Jessica Dade, Ph.D., Assistant Laboratory Director Dr. Dade joined the DDC team as an Assistant Laboratory Director in 2016. She is involved in final case review, as well as the review and interpretation of raw data for all paternity cases. Other professional positions held include: Postdoctoral Fellow, Department of Molecular Genetics at the University of Cincinnati. Dr. Dade has personally evaluated over 47,000 family relationship cases. Dr. Priya Kumar, Ph.D., Assistant Laboratory Director Dr. Kumar joined the DDC team as an Assistant Laboratory Director in 2017. She is involved in final case review, as well as the review and interpretation of raw data for all paternity cases. In addition to two Bachelor’s degrees, Dr. Kumar holds a Master’s Degree in Zoology from the University of Delhi and earned her Ph.D. from Miami University in Ohio. Other professional positions held include: Postdoctoral Research Fellow, Division of Endocrinology at Cincinnati Children’s Hospital Medical Center, and Adjunct Assistant Exhibit B Page 69 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 27 of 45 Professor at the University of Cincinnati. Dr. Kumar has personally evaluated over 41,000 family relationship cases. Dr. Alejandra Gutierrez, Ph.D., Assistant Laboratory Director Dr. Gutierrez joined the DDC team as an Assistant Laboratory Director in 2017. She is involved in final case review, as well as the review and interpretation of raw data for all paternity cases. In addition to two Bachelor’s degrees, Dr. Gutierrez earned her Ph.D. in Biochemistry and Microbiology from the National University of Cordoba in Argentina. Other professional positions held include: Laboratory Supervisor of Sorenson Genomics, and Principal/Research Scientist positions at Cytozyme Inc. and the University of Utah. Dr. Gutierrez has personally evaluated over 44,000 family relationship cases. Dr. Jessica Wagoner, Ph.D., Assistant Laboratory Director Dr. Wagoner joined DDC as an Assistant Laboratory Director in 2017. She is involved in final case review, as well as the review and interpretation of raw data for all paternity cases. In addition to her Bachelor of Science degree in Molecular Genetics, Dr. Wagoner earned her Ph.D. in Molecular Biology and Genetics from Cornell University. Other professional positions held include: Research Assistant positions at both Ohio State University and Cornell University. Dr. Wagoner has personally evaluated over 32,000 family relationship cases. Dr. Julie Heinig, Ph.D., Assistant Laboratory Director Dr. Heinig joined DDC in 2003 as an Assistant Laboratory Director and Forensic Technical Leader and is in charge of the forensic laboratory operations at DDC. In 2001 she received her Ph.D. from the University of Toronto in the area of Molecular Endocrinology and Development and has published several scientific papers. She oversees the operation and quality of DDC’s forensic department and performs DNA testing on crime scene evidence. In addition, she also performs professional case review and consultation. Dr. Heinig designed and prepared DDC's forensic laboratory for accreditations by the prestigious FQS-I (Forensic Quality Services-International) / ISOIEC 17025 and ASCLD/LAB-International (American Society of Crime Laboratory Directors/Laboratory Accreditation Board), setting up the laboratory procedures and performing validation studies. Before joining DDC, Dr. Heinig spent 5 years as a Senior Forensic Scientist/DNA Analyst at the Cuyahoga County Coroner's office, where she performed testing on the highly publicized Dr. Sam Sheppard case. Dr. Heinig has appeared as an expert in hundreds of court cases testifying on her own casework and that of other scientists. She has extensive experience in processing crime scenes. Dr. Heinig is an experienced lecturer, having hosted seminars and given lectures at the Coroner's office and off-site to various groups including attorneys, physicians, and universities. She has also conducted crime scene evidence collection workshops for law Exhibit B Page 70 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 28 of 45 enforcement agencies. Dr. Heinig has over 16 years of experience in the field of genetic testing. Chris Kraemer, Director, Laboratory Operations Mr. Kraemer joined DDC in 1997 as a Laboratory Technologist. He received his Bachelor’s Degree in Biology from the University of Cincinnati. He has 21 years of experience in the DNA testing field. Until recently Chris was responsible for oversight of the laboratory and data analysis departments, and for the overall efficiency of the DNA extraction, amplification, and data analysis areas of the laboratory. He has co-authored several articles in the Journal of Forensic Science. Articles include: “Distribution of HUMACTBP2 (SE33) alleles in North American populations;” “Specificity of sibship determination using the ABI Identifiler multiplex system;” and “Distribution of Penta B, Penta C, and Penta E alleles in the Asian, Black, Caucasian, and Hispanic populations.” Most recently he has taken on the role of managing the corporate compliance and safety programs at DDC. Chris is providing the leadership and coordinates with functional business managers to ensure regulatory & safety compliance. He ensures that the company is aware of and is taking measures to comply with all relevant laws and regulations. He reviews strategies, structures, and processes and confirms the company is operating according to specific rules and regulations. Dr. Todd Lewis, B.S., MBA, Ph.D, Quality Assurance Manager Dr. Todd Lewis joined DDC in 2018 as Quality Assurance Manager. He received his Bachelor’s degree in Biology, MBA in Healthcare Administration and Ph.D. in Molecular Genetics from Wright State University in Ohio. He has over 15 years of management and quality assurance experience. Previous to joining DDC, Dr. Lewis audited clinical trials for FDA, CFR and GCP regulatory compliance. Dr. Lewis is responsible for maintaining the laboratory accreditations for AABB, ANAB, CAP, CLIA, ISO/IEC 17025, NATA, NYSDOH and SCC. He develops and maintains the quality management system and monitors its performance. He also monitors the competency and performance of employees within their scope of work and ensures that processes are performed according to specified procedures, including quality control and reporting. Laboratory Staff Qualifications and Training DDC employs only degreed individuals to perform actual laboratory assays and has an extensive training program in place for all laboratory personnel. All laboratory personnel have at a minimum either an Associate’s degree in Science with on-site supervision or a Bachelor’s degree in Arts and Science. DDC’s training modules cover all aspects of testing from specimen collection to reporting of results. Instructional systems are designed and developed to produce a variety of education and training programs (facilitated workbook activities, audio, computer-based training lessons and simulations) or to adapt existing materials to meet the operational needs of the laboratory. Laboratory staff members are required to complete a documented training program and demonstrate competency in their specific area of testing before performing any testing. In addition, DDC performs routine direct observation assessments of the laboratory technologists in the form of practical, written, and problem solving evaluations to ensure that all laboratory employees maintain a Exhibit B Page 71 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 29 of 45 high level of competency. DDC has multiple laboratory departments and runs a multiple-shift operation. This scheduling operation as well as extensive cross training between departments allows for maximum flexibility to manage workload fluctuations while maintaining excellent report turnaround time and job versatility. Quality Control DDC has implemented a quality assurance program that exceeds the standards and guidelines set forth by the AABB, NYDOH (New York State Department of Health), ISO (International Standards Organization), CAP (College of American Pathologists) and several other accrediting organizations. The DDC Quality Manual describes our extensive quality policies and procedures covering all aspects of testing including document control, staff competency, proficiency testing, and confidentiality, to ensure the highest standards in DNA testing. DNA Diagnostics Center is the only DNA testing laboratory that performs every test twice, testing every genetic system in duplicate, not just a subset of the genetic markers. This process is more expensive and labor-intensive, however it is the most effective quality assurance program that ensures our testing is of the highest reliability and accuracy. This Dual Process™ is voluntary and far exceeds the industry standard. Every sample is independently logged-in, extracted, processed, and analyzed twice by two separate laboratory teams. The two sets of results are reviewed by at least two DNA experts prior to a final review by a Ph.D. Laboratory Director. DDC’s standard operating procedures and protocols control all aspects of our operations, including but not limited to, laboratory testing, non- conformances, confidentiality, training, safety, customer/supplier issues, and document control. In addition, we participate in external proficiency testing multiple times each year and conduct internal audits every year. Results of proficiency testing, internal audits, and external on-site inspections are used in developing subsequent preventive actions to further improve our quality system. Additional Key Staff (Non-Laboratory) Lori Neff, Director, Government Contracts Ms. Neff is responsible for directing and maintaining consistent policies and procedures for the government contracts team to include: customer service, interstate/institutional scheduling, specimen collection network, and case processing and reporting while ensuring the highest levels of service, contract compliance, and satisfaction to DDC’s customers. Ms. Neff has been involved in the paternity testing industry since 1992 and has served in various roles including Director, Customer Service, Orchid Cellmark (formerly GeneScreen), 2005- 2011, Specimen Collection Network Manager, 2002-2005, Bone Marrow Services Coordinator 1997-2002, Team Leader, Laboratory 1992-1997. Ms. Neff has worked directly with hundreds of child support agencies and staff, child protective services, tribal agencies, and other public social service agencies throughout the country that require paternity testing services. Ms. Neff works directly with customers to ensure contract compliance and overall customer satisfaction. She has conducted many self-collection training seminars, web Exhibit B Page 72 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 30 of 45 training, and general presentations for child support and social services staff. Ms. Neff has extensive experience working with subcontracted specimen collection services. Shauna Ford, Manager, Government Contracts, Customer Service and Scheduling Ms. Ford has been involved in various aspects of the paternity testing industry since 2005. She came to DDC in 2012 with over 7 years of experience working directly with child support staff and specimen collections. During her time with Orchid Cellmark she worked in case management, customer service, and the specimen collection network. Her previous experience in multiple roles has allowed her to better understand the issues that may arise in the field, as well as anticipate, prevent and solve problems. Ms. Ford has been employed with DDC since 2012 and earned subsequent promotions to Customer Service Team Leader and Manager of Government Contracts Customer Service and Scheduling. She manages the customer service and scheduling teams to ensure that the needs of the customer are the highest priority and all contract and service requirements are met in accordance with DDC procedures. Ms. Ford has trained many child support personnel for self-collections and web training. Sarah Ballard, Customer Service Account Coordinator Ms. Ballard has been with DDC since 2012 after having served as a Scheduling Coordinator with Orchid Cellmark since 2009. Ms. Ballard will continue to serve as the primary day-to- day representative for Fresno County. She is responsible for responding to account inquiries, providing information regarding case status, explaining laboratory results, and resolving client concerns so as to ensure the utmost in customer satisfaction. DDC’s customer service team is familiar with all contract requirements so that any representative can assist callers and handle inquiries. Kellie Bunch, Team Leader, Scheduling Ms. Bunch has been with DDC since 2007 and has over 9 years of scheduling experience, including experience with Fresno County. She has coordinated thousands of requests across the world. Ms. Bunch was promoted to Senior Team Member, then to Team Leader in 2015 and is well versed in all DDC contract requirements for scheduling. She has extensive experience and thorough knowledge with institutional collections. Jon Strong, Chief Information Officer Mr. Strong is an accomplished executive with experience in leadership, consulting and information technology, with more than 35 years in strategy, re-engineering, development, and transformation. While successfully leading large mission critical programs and transformations for companies from startups through $60 billion global enterprises, his deep understanding of the underlying technology combined with business savvy fosters alignment of the most technically demanding challenges with business requirements. He has exceptional strengths in analysis, project, and program planning and management, organizational optimization, and the delivery of technology-based business solutions. Jon has served in virtually every role in Information Technology, from developer through architect, head of portfolio, CTO and CIO, and has also built and led consulting organizations for some Exhibit B Page 73 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 31 of 45 of the largest professional services firms. Mr. Strong is Chief Information Officer at DDC, leading IT operations and development, as well as creating and executing the roadmap for evolution into the next generation of technology based and enhanced business solutions. Jon holds an MBA in management and finance from Drexel University, a Masters in Psychoanalysis from the Philadelphia School of Psychoanalysis and a Bachelors in Psychology from the University of Pennsylvania. Lauren Elkins, Supervisor, Specimen Collection Network Ms. Elkins is responsible for the day-to-day management and coordination of the specimen collectors. As part of DDC’s Specimen Collection Network, she has been responsible for locating collection facilities, recruiting, and training specimen collectors. In addition, she coordinates and manages specimen collection schedules and back up contingency plans for all of DDC’s government contract clients. She is responsible for monitoring the quality of collections, ensuring that all collectors and sites are adequately supplied with all materials required for specimen collections, processing collector payroll, and collecting DNA samples as needed. Ms. Elkins has additional Specimen Collection Network resources that also assist as needed. Angelina Perez, Crystal Carreon, Lori Perez, Phlebotomists and Specimen Collectors These individuals are responsible for performing specimen collections for Fresno County. They are required to maintain all DDC specimen collection standards and to follow all chain of custody protocols. They ensure the site has adequate coverage to perform in-county collections as well as jail collections on an ongoing basis. Phlebotomists and specimen collectors must have the ability to read, analyze, and interpret instructions, correspondence and contractual requirements. They are also required to recognize problems and respond to emergencies as well as have the ability to solve problems and deal with the different variables that arise while providing DNA collections. It is imperative that collectors pay close attention to detail and understand the impact the specimen collection process has on the outcome of testing. Collectors must have the ability to effectively present information to and respond to requests and questions from donors, customers, supervisors, and other child support employees. DDC recognizes that the specimen collector represents the company, has direct interaction with every client, and is one of the most important links between the client and laboratory. Specimen collectors must project a professional image, have confidence to perform their job competently, and demonstrate skill and compassion, all of which instill confidence in our clients. DDC’s company profile and key staff biographies provide a snapshot of the years of experience in the performance and implementation of comprehensive genetic testing services across a wide spectrum of satisfied clients. These skills, capabilities, and experience are applied to each new contract and have proven to be a successful roadmap in the execution of successful business transitions for many of our government clients. DDC’s experienced contract management team will ensure that all services provided meet or exceed the County’s expectations. Exhibit B Page 74 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 32 of 45 4. Bids must state method of testing to be performed. Include: a) All DNA probes used b) Source of DNA probes used c) Ownership of national database d) Size of isolated national database e) Ethnicity by percentage of national database (The Central Valley has a large Asian population that does not exist through the United States) Response: The ability to perform scientifically valid genetic testing that conforms to industry guidelines and the ability to defend its results in court if necessary are essential in the execution of this contract. DDC is committed to providing every client with accurate, thorough, and expedient paternity test results. DDC provides its clients with DNA testing performed using PCR (Polymerase Chain Reaction) technology and STR (Short Tandem Repeat) markers for routine analysis. DDC has been using STR technology since 1997, having conducted testing on over nine million five hundred fifty thousand (9,500,000) samples to date. This technology is approved by the AABB and is by far the most prevalent DNA testing methodology currently in use by AABB accredited laboratories. All STR markers employed by DDC for its routine parentage testing are commercially available, and their performance characteristics are well understood, reproducible, validated, and accepted by the scientific and legal communities. DDC will utilize either the Promega Fusion Kit or Life Technologies Global Filer Kit as the initial routine testing battery. Both of these kits are fully validated and offer twenty-four (24) loci that are common and informative allowing for greater discriminatory power than many other testing batteries. Additionally, they have rapid thermal cycling protocols, which results in reduced turnaround times and enables the focus of the laboratory to be on more value added activities. When necessary, DDC has additional systems that will be used for extended testing. In total, DDC has thirty- six (36) validated and commercially available STR systems (including Amelogenin) which will be deployed as necessary to ensure that tests completed for Fresno County will achieve a guaranteed minimum probability of paternity of 99.999% for standard cases though the majority of standard cases will have an average probability of paternity of 99.999999% or average combined paternity index of one billion to one (1,000,000,000:1). The available STR markers for use in the paternity testing panel are identified in the table below: D3S1358 D8S1179 D18S51 CSF1P0 D13S317 D5S818 D21S11 TP0X FGA F13B D7S820 D16S539 LPL TH01 vWA Penta E Penta D D2S1338 D19S433 Amelogenin F13A01 FESFPS Penta C D8S1115 D6S474 D22S1045 D2S441 SE33 D10S1248 D9S1122 D17S1301 D9S2157 D3S4529 D14S1434 D1S1656 D12S391 Exhibit B Page 75 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 33 of 45 Dual Process™ DDC was commended by the AABB in 2004 for being the first laboratory to truly offer double blind testing. DNA Diagnostics Center is the only DNA testing laboratory that performs every test twice, testing every genetic system in duplicate, not just exclusions, and not just a subset of the genetic markers. Our Dual Processing™ procedures ensure that each sample is tested in duplicate by two different teams working independently. Results from the two groups are compared upon completion of the analysis and must be in agreement for validation of the testing. This expensive and labor-intensive process is the most effective quality assurance program that ensures our testing is of the highest reliability and accuracy. This Dual Process™ is voluntary and far exceeds the industry standard. Every sample is independently logged-in, extracted, processed, and all genetic systems are analyzed twice by two separate teams. The two sets of results are reviewed by at least two DNA experts prior to a final review by a Ph.D. Director. Other laboratories provide duplicate testing, yet they only perform this testing on fewer than five (5) genetic markers. To the best of our knowledge, DDC is the only laboratory that performs duplicate testing on all genetic marker systems that are analyzed. This double blind testing on each sample ensures rapid turnaround times because there is no delay in repeating excluded alleged fathers. The standard battery and the additional validated systems will easily result in meeting the expected probabilities of paternity for alleged father inclusions and a minimum of three exclusions for alleged fathers that are not the biological father. Fresno County will continue to have a high level of confidence that the correct samples were tested and reported. DDC also has the capability to perform mitochondrial DNA (mtDNA) testing, Y- Chromosome, and X-Chromosome STR testing for complex and challenging cases. In addition, DDC can extract DNA from many different types of biological samples including standard buccal cheek swabs and blood samples as well as other tissue samples such as fingernail, bone, teeth, and hair root samples. DNA testing will be performed initially unless other testing methodologies are deemed necessary. DDC maintains national databases composed of thousands of genotypes from unrelated individuals of Caucasian, Black, Hispanic, Asian, and Native American ethnic backgrounds. The database sizes for the most commonly used STR systems range from 1,500 to 25,000 alleles, representing database sizes comprised of 750 to 12,500 unrelated individuals. All databases representing the loci examined are of adequate size to provide statistically significant results. Ethnicity is provided by self-identification. If tested parties are of mixed ethnic background or do not designate an ethnic background, calculations are performed using the existing databases adjusted to reflect the composition of the population based on the most recent U.S. Census Data. The databases used by DDC have been validated by statistical comparison to peer-reviewed scientific published databases. FBI-published databases can be utilized for calculations of more specific ethnicities; i.e. Japanese, Korean, Vietnamese, etc. Asian populations. Participation in the CAP external proficiency program indicates that the paternity indices calculated by DDC are within acceptable limits based on consensus results, which verifies the validity of our databases. The national database is comprised of the following ethnicities by percentage: Exhibit B Page 76 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 34 of 45 42% Caucasian 27% Hispanic 18% Black 10% Asian 3% Native American 5. Provide a statement regarding your ability to provide services to varied ethnic populations. Response: DDC has successfully provided genetic paternity testing services to Fresno County and its varied ethnic resident population since 2012. Having processed nearly 2,500 cases for Fresno County DCSS and DSS with a typical average probability of paternity or power of exclusion of 99.999999%, DDC has proven its capability to analyze the full range of cases for all ethnic populations in Fresno County. DDC utilizes databases composed of thousands of genotypes from unrelated individuals of Caucasian, Black, Hispanic and Asian ethnic backgrounds. If individuals are of mixed ethnic background or do not designate an ethnic background, the most conservative paternity index calculation is obtained by using the highest allele frequency for each system among Caucasian, Black, Hispanic and Asian allele frequency distributions. 6. Indicate in the bid whether the organization has conducted, documented, and published validation studies on their databases and biostatistical methods to ensure success on meeting California Kelly-Frye challenges. If so, copies of said studies are to be submitted with the bid. Response: The databases used by DDC have been validated by statistical comparison to peer-reviewed scientific published databases. Participation in the CAP external proficiency program assures that the paternity indices calculated by DDC are within acceptable limits based on consensus results, which verifies the validity of the databases DDC utilizes. DDC has also performed internal validation studies on our databases and bio-statistical methods which have been reviewed by AABB assessors and found to be appropriate. In addition, as one of the most accredited and certified laboratory testing facilities in the United States, DDC’s parentage testing is in strict accordance with the current edition of the AABB’s Standards for Relationship Testing Laboratories. DDC has maintained its AABB accreditation since 1996. In addition to our AABB accreditation, DDC holds additional accreditations and certifications from the following organizations: ACLASS, American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB), New York State Department of Health (NYDOH), Clinical Laboratory Improvement Amendments (CLIA), Standards Council of Canada (SCC), College of American Pathologists (CAP), the Ministry Of Justice (U.K.), and National Association of Testing Authorities (N.A.T.A.- Australia). Exhibit B Page 77 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 35 of 45 DDC supports all the scientific results generated in its laboratory with expert testimony, and our expert witnesses have testified in Frye hearings associated with both paternity and forensic DNA analysis in the past and will comply with all County requests for expert testimony and consultation services. All STR markers employed by DDC for its routine PCR parentage testing are commercially available, and their performance characteristics are reproducible, validated, and accepted by the scientific and legal communities. DDC’s genetic testing results have been submitted and accepted in thousands of legal proceedings throughout the country in all levels of court systems from local municipalities to federal courts. We have never encountered an issue with the admissibility of results based on the technologies utilized at our laboratory. DDC’S Chief Science Officer, Dr. Michael Baird, has testified in several Frye Hearings in California related to database and statistical issues. In addition, the following published studies are listed below. Copies of these reference materials are provided in Attachment #2. Reid, T., D. Ingala, C. Kraemer, W. Dage, C. Dieckhoner, J. Forman, D. Hodge, K. Johnson, C. Oatman, H. Schlotman, C. Schuh, and M. Baird. 2003. Distribution of HUMACTBP22 (SE33) Alleles in Three North American Populations. Journal of Forensic Sciences. 48:1422-1423. Peterson, J. W., T. Reid, C. Kraemer, D. Ingala, M. Baird, S. Lee, and R. Lee. 2005. Distribution of Penta B, Penta C, and Penta E Alleles in Asian, Black, Caucasian, and Hispanic Populations. Journal of Forensic Sciences. 50:966-968. 7. Provide the proposed day or days the draws/samples are to be completed/obtained, and specimen requirements. Response: As the current provider of genetic paternity testing services for Fresno County, DDC proposes to maintain the current collection schedule of every Tuesday from 8:00 am to 5:00 pm and every other Thursday from 8:00 am to 11:30 am. The RFQ states these collections are to occur in the afternoon, but are currently scheduled during the morning hours noted above. DDC plans to continue to retain the services of Angelina Perez, Crystal Carreon, and Lori Perez as the specimen collectors for Fresno County. All are experienced and have performed collections in Fresno County for a number of years. They are readily able to provide back-up services for each other in the event of an emergency. DDC is in frequent communication with our specimen collectors, and we have promptly made special arrangements to coordinate mobile or urgent jail collections. Should additional times and days be required due to increased testing volume, DDC will work with Fresno County to meet the needs of their clientele. DDC will continue to provide collection services in Fresno County at the B. F. Sisk Courthouse, and will continue to collect specimens at other locations as necessary (i.e., jails, hospitals, morgues, etc). DDC will collect specimens from each individual authorized by Fresno County. DDC Exhibit B Page 78 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 36 of 45 requires that all specimens are collected in accordance with AABB requirements and that strict chain of custody protocols are followed. The vast majority of samples that will be collected are buccal swab specimens, though special arrangements can be made for venous blood collection by a phlebotomist. DDC recommends genetic sample collection using buccal swabs, and this collection format will continue to be the primary method used for this contract. Buccal swab specimens are obtained by using cotton-tipped swabs to collect epithelial cells by gently stroking the lining of the mouth. These cells contain the DNA required to perform parentage testing and other human identity testing protocols. Obtaining DNA samples with buccal swabs is painless, non-invasive, and equally if not more reliable than DNA testing using blood. The buccal swab method is especially helpful for cases involving newborns, young children, and individuals who have undergone bone marrow transplants or recent blood transfusions. Four (4) swabs are collected from each individual to be tested. Two (2) swabs are used for the initial testing, and the two additional swabs are stored intact in the event additional testing is required in the future. For buccal swab collections, DDC will provide all specimen collection personnel with complete kits (containing color-coded envelopes, chain of custody documents, disposable gloves, instant camera and film, fingerprint pads, and overnight shipping materials (courier envelopes and pre-paid air bills). Detailed procedures are provided in DDC’s Specimen Collection Manual and are described below: 1. Identification of Individuals: DDC will ensure that proper photo identification is presented at the time of specimen collection. Adult parties must provide government- issued photo identification, which may include a driver’s license, military ID, passport, or other acceptable form of identification. The custodial parent/legal guardian of the child(ren) is also instructed to bring a birth certificate. After the validity of the identification is verified by the specimen collector, the identification number is recorded on the Client Identification/Chain of Custody form along with social security numbers and dates of birth. 2. Completion of the Client Identification/Chain of Custody Form: The specimen collector will legibly complete this document, including the following information: a) County case number and docket number (if applicable) b) Name of requesting agency c) Collection site information (facility name and address) d) Names of all parties in the case, even if all parties are not collected at the same time e) The Sample Collector’s Statement on the back of the form, indicating date and time of collection, in addition to the collector’s name and signature f) Race of mother and alleged father g) Sex of child Exhibit B Page 79 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 37 of 45 h) Dates of birth for all parties i) Social Security Numbers for all parties (if available) j) Other ID number (government-issued photo identification) k) Transfusion and bone marrow transplant history l) Consent signatures of parties being collected or the guardian for a child being tested. 3. Photograph Parties: The specimen collector will take an instant photograph of all the parties to be collected. If the parties are unwilling to take a picture of all three individuals together, the mother and child will be photographed together and the alleged father(s) separately. The adult parties then sign and date their own and their children’s photographs. The collector also initials the photograph(s). Photographs are then attached to the back of the chain of custody form in the space indicated. 4. Take Thumbprints: The specimen collector will have the client press their thumb on the colorless pad and then press the area in the appropriate section on the chain of custody form. The client’s right thumb is used unless there is a problem such as an injury or missing digit. If the client’s left thumb is used, it is indicated next to the sticker. 5. Collect Specimens: The specimen collector will collect buccal swab samples from one individual at a time per the following protocol: • A new pair of disposable gloves is used for each client collected to prevent contamination of the sample and to protect the collector. • Envelopes are color-coded to minimize the chance of sample switching (yellow for child, pink for mother, or blue for alleged father). • The swab packages are opened to expose 2-3 inches of the swab sticks. • One swab at a time is removed and the collector will brush the inside of one cheek, vigorously using a twirling motion to obtain epithelial cells. The swab is replaced in its original package, and the process is repeated with the second swab. Two swabs are collected from the opposite cheek. (Total of 4 swabs per client). • The swab packages are then placed into the appropriately colored envelope, then sealed. • The envelope is labeled with the full name of the party collected, the date, initials of specimen collector, and initials of the collected party. The party whose sample is in the envelope initials the envelope to indicate the sample was properly labeled and that the name(s) match those on the chain of custody documentation. 6. Completion of Materials for Case: The specimen collector will place all of the following items into one tamper-proof package for each case (swab envelopes for parties collected, chain of custody document, judicial or administrative orders). 7. Prepare Shipment: All tamper-proof packages containing case materials that are collected on a particular day are then placed into the shipping pouch provided by the Exhibit B Page 80 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 38 of 45 overnight courier service. The specimen collector will complete the air bill, attach it to the package, and retain the receipt for tracking purposes. 8. Provide your median and maximum laboratory wide turnaround time. Response: DDC will continue to deliver paternity testing results well within the median laboratory time frame as specified in the RFQ. Performance for Fresno County will meet or exceed laboratory-wide performance. A notarized paternity testing report, signed by a member of DDC’s doctoral staff, which summarizes the genetic testing data and conclusions determined, will be issued to the Fresno County DCSS or DSS in a turnaround time that is well within the specified turnaround time of four weeks from draw date to issuance of report. During calendar year 2018, DDC has delivered testing results in an average turnaround time of 6.3 days from the last sample collection date. Our expedient turnaround time allows for efficiency with which cases will be resolved, reduces costs within the child support system, and also reduces the stress on clients caused by the additional wait time and repeated phone calls from clients to caseworkers. DDC’s laboratory-wide median turnaround time for 2018 has been four to seven (4-7) days from the last sample collection, with all cases being reported well within the four-week requirement. On occasion, a case will require additional or specialized testing and may require additional time, but even those cases have been reported within two to three (2-3) weeks, well within the four-week requirement. For 2018, Fresno County case median turnaround time has been 6.3 days. DDC will continue to monitor and provide expedient turnaround time to Fresno County that meets or exceed the laboratory-wide median turnaround time. 9. Any special proposed uses of County of Fresno resources and personnel need to be noted. Response: DDC proposes to continue to utilize the drawing station located at the B.F. Sisk Courthouse, Room # 334. There will be no further use of Fresno County resources or personnel for the completion of services under this contract. DDC will provide alternate drawing locations within Fresno County as required. 10. A list of any special services or access to other experts and resources which the firm maintains for the purpose of this contract need to be noted. Response: As the current provider of genetic paternity testing services to Fresno County, DDC will continue to offer many value-added services to Fresno County, including the following: Electronic Result Availability and Website Services All data regarding partial case and archived samples, case status, and test results is available electronically twenty-four (24) hours per day/7 days per week on DDC’s secure web portal Exhibit B Page 81 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 39 of 45 application (https://contracts.dnacenter.com) called DDC Direct Connect. DDC’s on-line case management and tracking system is a real time interface that provides unlimited access to: • Case status information • Information regarding partial cases • Scheduling and appointment information • Sample collection data • On-line case results (paternity test reports) • Account summary information (statistics) The secure web portal application also affords DDC’s government customers the ability to: • Download and print paternity test reports • Schedule genetic testing appointments • Complete on-line ordering of sample collection kits and supplies • Complete retest authorizations for previously tested parties • Download DDC’s Specimen Collection Manual • View DDC’s Specimen Collection Training Video • Perform a multitude of data queries; e.g. reports can be generated of all outstanding partial cases within a specified time period; all cases reported within a specific time period; all samples collected on a particular date, etc. Access to this web site provides customers with the ability to track and collect performance data on-demand for cases received in our laboratory. Data may be accessed via DCSS/DSS case number, tested party name (first and/or last), and by last four digits of social security numbers. The site provides our customers with the option of an almost paperless and convenient interface with our paternity services division. In addition, DDC will provide real- time email notification that test results are completed, uploaded to the web interface, and ready to be viewed. Authorized Fresno County staff may print a fully completed report ensuring legibility, accuracy and convenience. Like the traditional hard copy report, this electronic report includes the Ph.D.’s signature, report of findings, conclusions, chain of custody documentation, thumbprint, and photographic images of the clients. The user manual for DDC Direct Connect is provided in Attachment #3. Sample and Data Reuse For all samples received under the terms of this contract, DDC will continue to store and reuse genetic testing results when requested for determining parentage in subsequent cases. For example, when a second alleged father is to be tested with a mother and child that has previously been tested, DDC will utilize the initial testing results for the mother and child with the testing results obtained for the new alleged father to complete the case. This retest procedure is now commonplace with many state and county child support agencies, and can be accomplished by submitting the request through DDC Direct Connect. DDC will maintain Exhibit B Page 82 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 40 of 45 all testing data records for Fresno County, and will match up a previously tested party in a new case. DDC has an efficient process to complete these requests, and most requests are routinely processed within a few hours of receipt. The previous case numbers and names are validated and then matched and incorporated into the new case. Historically, approximately eight to ten percent (8-10%) of all cases tested for Fresno County involve the reuse or retesting of one or more genetic samples, and DDC utilizes samples and data from as far back as 2009, when the contract was managed by Orchid Cellmark. This data reuse procedure will continue to save Fresno County a significant amount of money if historical data can be utilized for determining parentage in subsequent cases and prevent the necessity to recollect samples. Expert Witness Services DDC’s highly qualified doctoral staff provides litigation support to our customers, including pre-trial preparation and in-court explanation of genetic paternity testing procedures and subsequent results. DDC’s expert witnesses have testified in hundreds of cases and consistently provide clear, accurate testimony. DDC’s Chief Scientific Officer, Dr. Michael Baird, Ph.D. was the first DNA expert to testify in a U.S. court using DNA evidence. Since then, he has testified over 500 times in courtrooms throughout the United States. DDC doctoral staff members have many years of combined experience providing expert witness services for both paternity-related and criminal trials. Their technology-specific knowledge, qualifications and experience are highly respected in the industry. DDC’s expert witnesses will continue to provide the following services to Fresno County at no additional charge: • General consultation on paternity analysis; • Statistical analysis for non-standard paternity cases including avuncular analysis and family reconstruction and all necessary consultation to understand the results; • Expert testimony for trial and hearings; • Assist in the cross examination of defense experts; • Provide written and/or telephone technical consultation; • Telephonic/video depositions; • Provide pattern trial questions for expert testimony; • Assist counsel in preparation for the presentation of scientific evidence at trial and in depositions; • Fill requests for document production; • Provide affidavits regarding specific case events; • Explain difficult to understand case results in layman’s terms. Curricula Vitae for DDC’s doctoral staff who will continue to provide expert witness services to Fresno County are provided in Attachment #1 of this response. All DDC Laboratory Directors and Assistant Laboratory Directors are required to have completed a doctoral degree in a biological science in addition to advanced training in genetic testing. All Laboratory Directors at DDC meet these minimum qualifications and requirements and are competent to testify to the theory and practice of current DNA technology as used in the parentage determinations, laboratory procedures, specimen chain of custody, and statistical Exhibit B Page 83 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 41 of 45 analysis and interpretation of test results. In total, the expert witness staff at DDC includes twelve (12) prominent Ph.D.s. that will supply technical consultation and litigation support services. Costs associated with providing expert witness services, including travel, lodging, etc. are included in the all-inclusive per person rate presented in the Cost Proposal. Quality Control Procedures that Exceed AABB Standards DDC recognizes that the accuracy of testing results produced in the laboratory is of utmost importance. All samples are handled, processed and analyzed in accordance with validated procedures and in a manner that ensures the accuracy and reliability of test results. DDC has made several investments in its testing process that significantly reduce the risk of sample swapping and other errors. These reduce the incidence of human error, which in the case of paternity testing, often leads to false paternity exclusions. DDC understands that the County wants to minimize the potential for false exclusions and has made many process enhancements to ensure they do not occur. The following is a summary of DDC’s comprehensive and stringent quality control procedures, many of which exceed AABB minimum standards. Dual Process™ (Specimens are Analyzed Twice from Separate Isolations) DDC was commended by the AABB in 2004 for being the first laboratory to truly offer double blind testing. DNA Diagnostics Center is the only DNA testing laboratory that performs every test twice, testing every genetic system in duplicate, not just exclusions, and not simply a subset of the genetic markers. This process is more expensive and labor- intensive; however, it is the most effective quality assurance program that ensures our testing is of the highest reliability and accuracy. Our Dual Processing™ procedures ensure that each sample is tested in duplicate by two different teams working independently. Results from the two groups are compared upon completion of the analysis and must be in agreement for validation of the testing. This Dual Process™ is voluntary and far exceeds the industry standard. Every sample is independently logged-in, extracted, processed, and all genetic systems are analyzed twice by two separate teams. The two sets of results are reviewed by at least two DNA experts prior to a final review by a Ph.D. Director. Fresno County will continue to have a high level of confidence that the correct samples were tested and reported. Color Coding of Specimen Envelopes and Chain of Custody Documentation Each specimen collection kit consists of color-coded envelopes containing four (4) buccal swabs for each party to be tested. These features provide added measures to protect against the possibility of inadvertently switching samples at the time of sample collection. Blue envelopes are used for alleged fathers, pink envelopes are used for mothers, and yellow envelopes are utilized for child(ren). Automated Processes Minimize Potential for Human Error DDC utilizes automated processes and equipment whenever possible. By using sophisticated robotic sample handling equipment, the potential for human error in manipulating the layout and placement of samples during handling and the testing process is greatly reduced. This automation is not required by the AABB. Exhibit B Page 84 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 42 of 45 Bar Coding Samples at the Laboratory All samples and chain of custody forms are bar coded with unique numerical identifiers. The bar code numbers are assigned using a proprietary software application, and each bar code is applied to the sample during the accessioning process. Prior to the testing process, the assigned bar codes are rescanned, and the system verifies the tested party name and bar code match. This auditing procedure ensures that each sample has been independently verified twice before entering the laboratory. At each additional step in the analysis procedure, these bar codes are scanned with a bar code reader and checked for concordance. If the bar codes do not match, laboratory processing is halted. Additionally, anytime a sample is transferred, a unique reference number is linked to that sample. This unique reference is 32 digits represented by a 2D bar code, the unique reference number is known as a Globally Unique Identifier (GUID). There is no limit to the quantity of these unique linked numbers, thereby adding this quality process each time the sample is transferred. This concept in process control nearly eliminates the possibility of sample switching in the laboratory. This sample bar coding goes far beyond AABB standards for sample identification. Utilizing barcoding provides an additive quality feature after all names have been verified and checked for accuracy on the samples and chain of custody prior to linking with the GUID as described above. If there is an issue with any labeling involving a tested party name, laboratory analysis will not be conducted. The use of bar codes enhances quality assurance and in no way replaces the tested party name review. Multiple Exclusions When laboratory data indicates exclusionary results, a minimum of three (3) exclusions will be required; however, most cases processed by DDC will have more than four exclusions. AABB standards require a minimum of two exclusions, but DDC has adopted a stricter policy, which realistically eliminates the possibility of false exclusions due to mutation events. Gender Marker Amelogenin The inclusion of the gender marker Amelogenin in the testing battery is an important quality control feature. This internal control helps confirm the identities of the tested parties (mother and father) and the identities of the children as well (especially in multiple-child cases) by verifying the gender of each party collected. If discrepancies exist between the gender identified on the chain of custody form and the test outcome (i.e. if a brother and sister’s sample were switched), the software identifies this discrepancy during the Laboratory Director’s review and further investigation will be required. No report will be generated until all issues have been resolved. Use of this marker to identify sample switching is not an AABB requirement. Computer Verification of Sample Placement DDC’s software verifies testing results by analyzing all permutations of sample party identification within a case. In other words, the computer will show a color alert if the father is erroneously placed into the role of mother, the mother is put into the erroneous role of Exhibit B Page 85 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 43 of 45 child, the child is put into the erroneous role of father, and all other permutations possible. Additionally, if testing results in a maternal exclusion, then DDC software will "red flag" all maternal exclusions. Additionally, DDC's software will alert the analyst to any cloning of samples within a case to prevent any possible sample duplications. The software also alerts the analyst to any inclusions between the mother and father to prevent any potential mother/child switches within a case. Training Seminars Upon request, DDC will present experts in genetic testing and related fields to conduct training seminars to update your employees, attorneys, and support staff in paternity actions, collection methods, and advances in the field of testing related to paternity testing. In addition, as a national provider of testing as well as an active participant in NCSEA (National Child Support Enforcement Association), we can communicate the latest industry trends observed in paternity establishment and disestablishment. We have conducted many training seminars for Child Support Enforcement agencies throughout the United States. Each seminar is unique and is designed to address the needs and interests of its participants. With the use of audiovisual aids and other distributed training materials, DDC’s personnel are able to bring complex scientific matters to a comfortable level of comprehension. Training sessions will take place at a location designated by, and at the convenience of Fresno County. DDC will provide training sessions and all necessary training materials at no additional cost. 11. Provide a copy of your AABB accreditation. Response: DDC is one of the most accredited and certified laboratories in the DNA testing industry. We have received and currently hold all of the necessary accreditations and licensures to perform biological relationship testing in all 50 states and worldwide. All testing performed for Fresno County will continue to be in strict compliance with the current edition of the AABB’s Standards for Relationship Testing Laboratories. DDC has maintained its AABB accreditation since 1996. In addition to our AABB accreditation, DDC holds additional accreditations and certifications from the following organizations: ACLASS, American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB), New York State Department of Health (NYDOH), Clinical Laboratory Improvement Amendments (CLIA), Standards Council of Canada (SCC), College of American Pathologists (CAP), the Ministry Of Justice (U.K.), and National Association of Testing Authorities (N.A.T.A.-Australia). Details of these accreditations are provided below: a) Parentage Testing by the AABB (formerly the American Association of Blood Banks) since 1996. b) CLIA Laboratory Certificate of Accreditation by the U.S. Department of Health & Human Services since 1996. c) Parentage/Identity Testing by the New York State Department of Health (NYDOH). The NYDOH monitors the overall quality of testing conducted on specimens obtained in New Exhibit B Page 86 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 44 of 45 York State by out-of-state laboratories. The state’s Clinical Laboratory Evaluation Program (CLEP) ensures the accuracy and reliability of analytical results obtained through on-site inspections, proficiency testing, and evaluation of personnel qualifications. DDC has been accredited by New York State since 1998 and undergoes an on-site assessment every two years by an external assessor. d) Paternity/Family Relationship testing by the Standards Council of Canada (SCC). The SCC accredits laboratories performing forensic objective testing such as that involving parentage and family relationships. Their accreditation verifies that an organization has the necessary competence to execute these functions. The SCC also conducts regular on- site assessments of DDC’s laboratory and reviews its performance to ensure the facility is conforming to the Council’s reporting requirements and quality expectations. e) ISO 17025/IEC by ACLASS Accreditation Services. DDC has been certified to ISO standards since 2003, which are the international standards set for ensuring the technical competency of laboratories. ISO/IEC 17025 covers every aspect of laboratory management, ranging from sample preparation to analytical testing proficiency, to record keeping and reports. f) Parentage Testing and other Molecular Pathology Testing by The College of American Pathologists (CAP) since 2004. g) ASCLD/LAB-International by the American Society of Crime Laboratory Directors/Laboratory Accreditation Board since 2005. ASCLD/LAB-International is the most stringent accreditation program for forensic DNA laboratories. h) National Association of Testing Authorities (N.A.T.A.) is the authority that provides independent assurance of technical competence through a proven network of best practice industry experts. NATA provides assessment, accreditation, and training services to laboratories and technical facilities throughout Australia and internationally. DDC has a strong Quality Management System and consistently exceeds the standards set by its accrediting organizations. DDC has had thirty-five (35) assessments from various accreditation bodies with no findings of non-conformances with their standards. Copies of all current accreditation certificates are provided in Attachment #4. DDC will continue to maintain the necessary accreditations throughout the length of this agreement. 12. Provide a sample Test Result report. Response: DDC will continue to submit standard written reports including an interpretation of test results for each individual case in accordance with California state law and all applicable statutes. Paternity evaluation reports include clear, concise language to provide an understandable interpretation of testing results. Each paternity evaluation report will include, at a minimum, the following information: • Table of results; • Interpretation of the results; • Probability of paternity; • Effect of prior probability and likelihood of paternity; and Exhibit B Page 87 of 188 Fresno County, California RFQ # 18-058: Proposal to Provide DNA Paternity Testing Services Submitted by DNA Diagnostics Center, Inc. Page 45 of 45 • Statement of exclusion, if applicable. In addition, DDC’s paternity testing reports include the following information: • Tester’s name, title and qualifications • IV-D case number and court or administrative order number • Names of tested parties • Date(s) of specimen collection • Types of DNA tests performed • Combined paternity index • Conclusions • Signed Chain of Custody form • Donor’s photographs and thumbprints • Copy of judicial or administrative order for genetic testing, if provided • Signature of Ph.D. Laboratory Director conducting case review • Notary signature and seal DDC is also able to provide, upon request, reports in Spanish or other languages. Copies of sample inclusionary and exclusionary paternity reports are provided in Attachment #5. DDC will provide certified results to other parties at the County’s request. DDC will maintain an electronic copy of the test results and chain of custody documentation. In addition, testing outcomes will be available to authorized DCSS and DSS representatives via DDC’s secure website. This website provides caseworkers with the ability to track and collect performance data on all cases received in our laboratory 24 hours a day. Our proprietary interface, https://contracts.dnacenter.com, offers a direct link to child support offices allowing immediate access to information stored in our database for paternity cases. This service feature provides our customers with the option of an almost paperless and convenient interface with our laboratory. In addition, DDC will provide email notification that test results are completed, uploaded to the web interface, and ready to be viewed. Authorized DCSS and DSS staff may print a fully completed report ensuring legibility, accuracy and convenience. Like the traditional hard copy report, this electronic report includes the Ph.D.’s signature, report of findings, conclusions, chain of custody documentation, thumbprint, and photographic images of the clients. Exhibit B Page 88 of 188 REVISED CHECK LIST This Checklist is provided to assist the vendors in the preparation of their bid response. Included in this list, are important requirements and is the responsibility of the bidder to submit with the bid package in order to make the bid compliant. Because this checklist is just a guideline, the bidder must read and comply with the bid in its entirety. Check off each of the following: 1.The Request for Quotation (RFQ) has been signed and completed. 2.Addenda, if any, have been signed and included in the bid package. 3.Subcontractors page as provided with this RFQ. 4.The Participation page as provided within this RFQ has been signed and included 5.The completed Reference List as provided with this RFQ. 6.The completed Comply/Not Comply as provided within this RFQ. 7.The Quotation Schedule as provided with this RFQ has been completed, price reviewed for accuracy and any corrections initialed. 8.Indicate all of bidder exceptions to the County’s requirements, conditions and specifications as stated within this RFQ. 9.Bidder to Complete page as provided with this RFQ. 10.Response to Submittal Requirements. 11.Return checklist with RFQ response. 12.Completed RFQ in pdf format, electronically submitted to the Bid Page on Public Purchase. Exhibit B Page 89 of 188 Curriculum Vitae Kathy L. Leis Page 1 of 2 CURRICULUM VITAE KATHY L. LEIS EDUCATION B.S. – Medical Technology 1983 University of Dayton Dayton, OH A.S. - Medical Laboratory Technology 1981 Kettering College of Medical Arts Kettering, OH PROFESSIONAL EXPERIENCE Vice President, Operations 2014 - Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Director of Operations 2012 - 2014 DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Director of Operations 1997 - 2012 Orchid Cellmark Inc. Dayton, OH Paternity Laboratory Supervisor 1985 - 1997 GeneScreen Dayton, OH Staff Medical Technologist/Generalist 1984 - 1985 St. Luke’s Medical Center Maumee, OH Staff Medical Technologist, Transfusion Service 1981 - 1983 Kettering Medical Center Kettering, OH Phlebotomist 1979 - 1981 Kettering Medical Center Kettering, OH Exhibit B Page 90 of 188 Curriculum Vitae Kathy L. Leis Page 2 of 2 PROFESSIONAL AFFILIATIONS  American Society of Medical Technologists  Ohio Society of Medical Technologists  American Association of Blood Banks  American Society of Clinical Pathologists  American Society for Histocompatibility and Immunogenetics PUBLICATIONS Miller Raymond D ; Phillips Michael S ; JO Inho ; Donaldson Miriam A ; Studebaker Joel F. ; Addleman Nicholas ; Alfisi Steven V. ; M Wendy ; Bhatti Hamid A. ; Callahan Chad E. ; Carey Benjamin J. ; Conley Cheryl L. ; Cyr Justin M. ; Derohannessian Vram ; Donaldson Rachel A. ; Elosua Carolina ; Ford Stacey E. ; Forman Angela M. ; Gelfand Craig A ; Grecco Nicole M. ; Gutendorf Susan M.; Hock Cricket R. ; Hozza Mark J.; H Soyoung ; Sun Miin ; Jackson Diana L. ; Sangmeeahn Jo ; Jung Sung-Chul ; Kim Sook ; Kimm Kuchan ; Kloss Ellen F. ; KOBOLDT Daniel C. ; KUEBLER Jennifer M. ; KUO Feng-Shen ; LATHROP Jessica A. ; LEE Jong-Keuk ; Leis Kathy L. ; Livingston Stephanie A. ; Lovins Elizabeth G. ; Lundy Maria L.; Maggan Sima ; Minton Matthew ; Mockler Michael A. ; Morris David W. ; Nachtman Eric P. ; Oh Bermseok ; Park Chan ; Park Chang-Wook ; Pavelka Nicholas ; Perkins Adrienne B. ; Restine Stephanie L ; Sachidanandam Ravi ; Reinhart Andrew J. ; Scott Kathryn E. ; Shah Gira J. ; Tate Jatana M. ; Varde Shobha A. ; Walters Amy ; White J. Rebecca ; Yoo Yeon-Kyeong ; “High-Density Single-Nucleotide Polymorphism Maps of the Human Genome”, Genomics ISSN 0888-7543, 2005, vol. 86, no2, pp. 117-126. Gutendorf, R. W. and K. Leis, “An Apparent Maternal Exclusion Resolved by Family Studies”, OABB/IABB, 1986. Gutendorf, R. W., K. Leis, and L. Frabotta, “Exclusion of Paternity Without Testing the Mother”, OABB, 1987. Yates, J., P. Chapman, and K. Leis, “Evaluations of Indirect Exclusions”, OABB, 1991. Gutendorf, R. W., R. Smith, K. Leis, and J. Yates, “Paternity Inclusion in the Presence of Multiple Exclusions”, Annal. of Clin. and Lab Sci., Vol. 21, No. 4, 1991. Exhibit B Page 91 of 188 Curriculum Vitae Michael L. Baird, Ph.D. Page 1 of 7 CURRICULUM VITAE MICHAEL LEONARD BAIRD, Ph.D. EDUCATION Ph.D. – Genetics 1978 The University of Chicago Chicago, IL M.A. - Biology 1973 State University of New York New Paltz, NY B.A. - Biology 1971 State University of New York Madison, NY PROFESSIONAL EXPERIENCE Chief Science Officer 2010-Present DNA Diagnostics Center (DDC) Fairfield, OH Associate Vice President & Laboratory Director 2008 - 2009 DNA Diagnostics Center Fairfield, OH Laboratory Director 2002 - 2008 DNA Diagnostics Center Fairfield, OH Senior Director, Laboratory Operations 2001 - 2002 Orchid Diagnostics Stamford, CT Vice President, Laboratory Operations 1992 - 2001 Lifecodes Corporation Stamford, CT Director Business Development 1990 - 1992 Lifecodes Corporation Stamford, CT Exhibit B Page 92 of 188 Curriculum Vitae Michael L. Baird, Ph.D. Page 2 of 7 Director of Forensics & Paternity 1986 - 1990 Lifecodes Corporation Stamford, CT Senior Scientist 1982 - 1986 Lifecodes Corporation Stamford, CT Adjunct Assistant Professor 1986 - 1992 New York Medical College New York, NY Research Associate 1979 - 1982 Columbia University Postdoctoral Fellow 1978 - 1979 University of Michigan Ann Arbor, MI PROFESSIONAL ASSOCIATIONS • The American Academy of Forensic Sciences • American Association for the Advancement of Science • American Association of Blood Banks (AABB) • American Society of Hematology • American Society of Human Genetics • Sigma Chi Society • International Society for Forensic Genetics • American Society of Crime Laboratory Directors • American Society of Histocompatibility and Immunogenetics • International Association for Identification LICENSES AND CERTIFICATIONS New York State Department of Health Certificate of Qualification Number B 3447 Histocompatibility (HLA typing with DNA probes) Paternity/Identity Analysis State of Connecticut Department of Health Certificate of Qualification Number 381 Clinical Laboratory Director Department of Health & Human Services Laboratory Registration Certificate Exhibit B Page 93 of 188 Curriculum Vitae Michael L. Baird, Ph.D. Page 3 of 7 CLIA ID #36D0910013 American Society of Histocompatibility and Immunogenetics Laboratory Director of Histocompatibility Laboratory PROFESSIONAL SOCIETY POSITIONS • AABB: Chair Parentage Testing Accreditation Program Unit, Liaison to Parentage Testing Standards Committee, Member of Accreditation Program Committee, Assessor of Parentage Testing Laboratories for AABB • Human Identity Trade Association, President • American Society of Histocompatibility and Immunogenetics, Inspector PUBLICATIONS 1. Garber, E. D., M. L. Baird, and D. J. Chapman. 1975. Genetics of Ustilago violacea. I. Carotenoid mutants and carotenogenesis. Botanical Gazette. 136: 341-346. 2. Garber, E. D., M. L. Baird, and L. M. Weiss. 1978. Genetics of Ustilago violacea. II. Polymorphisms of color and nutritional requirements of sporidia from natural populations. Botanical Gazette. 139:261-265. 3. Catrall, M. E., M. L. Baird, and E. D. Garber. 1978. Genetics of Ustilago violacea. III. Crossing over and nondisjunction. Botanical Gazette. 139:266-270. 4. Baird, M. L. and E. D. Garber. 1979. Genetics of Ustilago violacea. IV. An electrophoretic survey for urease variants in wild strains. Botanical Gazette. 140:84-88. 5. Baird, M. L. and E. D. Garber. 1979. Genetics of Ustilago violacea. V. Outcrossing and selfing in teliospore inocula. Botanical Gazette. 140:89-93. 6. Bank, A., J. G. Mears, F. Ramirez, M. Baird, and J. Feldenzer. 1979. Organization of normal and abnormal human globin genes by restriction enzyme analysis. In Sigler, P. B. (Ed.): Proceedings of the Symposium on the Molecular Basis of Mutant Hemoglobin Dysfunction. Illinois. Elsevier/North Holland. 7. Bank, A., J. G. Mears, F. Ramirez, A. L. Burns, S. Spense, J. Feldenzer, and M. Baird. 1980. The organization of the gamma-delta-beta gene complex in normal and thalassemia cells. In Huisman, T. H. J. (Ed.): Proceedings of the Seminar of Abnormal Human Hemoglobins and Red Cell Enzymes. New York. 8. Bank, A., J. G. Mears, F. Ramirez, A. L. Burns, S. Spence, J. Feldenzer, and M. Baird. 1980. The organization of the gamma-delta-beta gene complex in normal and thalassemia cells. Hemoglobin. 4:497-507. Exhibit B Page 94 of 188 Curriculum Vitae Michael L. Baird, Ph.D. Page 4 of 7 9. Bank, A., A. L. Burns, M. Baird, and R. Pergolizzi. 1981. Globin gene pathology: Clues to gene function and hemoglobin switching. In Stamatoyannopoulos, G. and A. W. Nienhuis (Eds.): Organization and Expression of Globin Genes. Liss/New York. 10. Baird, M. L., C. Driscoll, H. Schreiner, G. V. Sciarratta, G. Sansone, G, Niazi, F. Ramirez, and A. Bank. 1981. A nucleotide change at a splice junction in the human beta globin gene is associated with beta zero thalassemia. Proceedings of the National Academy of Sciences. 78:4218-4221. 11. Baird, M., H. Schreiner, C. Driscoll, and A. Bank. 1981. Localization of the site of recombination in formation of the Lepore Boston globin gene. Journal of Clinical Investigation. 68:560-564. 12. Driscoll, C., M. Baird, and A. Bank. 1981. A new polymorphism in the human beta globin gene useful in antenatal diagnosis. Journal of Clinical Investigation. 68:915-919. 13. Burns, A. L., S. Spence. K. A. Kosche, F. Ramirez, J. G. Mears, H. Schreiner, C. Miller, M. Baird, D. Leibowitz, P. Giardina, A. Markenson, and A. Bank. 1981. Isolation and characterization of cloned DNA: The delta and beta globin genes in homozygous beta plus thalassemia. Blood. 57:140-146. 14. Bank, A., M. Baird, M. C. Driscoll, R. G. Pergolizzi, and S. Spence. 1982. Gene defects in the thalassemias: Recent advances in detection and treatment. In Cao, A., Carassi, U., and Rowley P. (Eds). Organization of Globin Genes. Liss/New York. 15. Bank, A., S. E. Spence, P. G. Pergolizzi, M. C. Driscoll, and M. Baird. 1983. Gene defects in beta thalassemia. In Goldwasser, E. (Ed.): Regulation of Hemoglobin Biosynthesis. Elsevier/Holland. 16. Baird, M., M. C. Driscoll, B. Ramot, Y. Ohta, F. Nakamura, A. Bloom, and A. Bank. 1983. Gene analysis in delta-beta and delta zero thalassemia. Journal of Biological Chemistry. 259:512-515. 17. Beldjord, C., C. Lapourmourlie, M. Baird, R. Girot, L. Adjrad, G. Lenoir, M. Benabadji, and D. Labie. 1983. Four new haplotypes observed in Algerian beta thalassemia patients. Human Genetics. 65:204-206. 18. Baird, M., E. Kanter, R. Schaler, and I, Balazs. 1986. Application of DNA polymorphisms to the forensic examination of dried blood stains. In Brinkmann, B. and Henningsen, K. (Eds): Advances in Forensic Haemogenetics. pp 351-355. 19. Baird, M., A. Giusti, I. Balazs, and J. Glassberg. 1986. Application of DNA polymorphisms to the forensic examination of semen. In Brinkmann, B. and Henningsen, K. (Eds.): Advances in Forensic Haemogenetics. pp 354-360. 20. Balazs, I., K. Wexler, L. Nicholas, L. Miyazaki, A. Giusti, M. Baird, P. Rubinstein, F. Allen, and L. Sussman. 1986. Application of DNA polymorphisms to the determination of paternity. In Brinkmann, B. and Henningsen, K. (Eds): Advances in Forensic Haemogenetics. pp 196-200. Exhibit B Page 95 of 188 Curriculum Vitae Michael L. Baird, Ph.D. Page 5 of 7 21. Kanter, E., M. Baird, R. Shaler, and I. Balazs. 1986. Analysis of restriction fragment length polymorphisms in deoxyribonucleic acid (DNA) recovered from dried bloodstains. Journal of Forensic Sciences. 31:403-408. 22. Giusti, A., M. Baird, S. Pasquale, I. Balazs, and J. Glassberg. 1986. Application of deoxyribonucleic (DNA) polymorphisms to the analysis of DNA recovered from sperm. Journal of Forensic Sciences. 31:409-417. 23. Baird, M., I. Balazs, A. Giusti, L. Miyazaki, L. Nicholas, K. Wexler, E. Kanter, J. Glassberg, F. Allen, P. Rubinstein, and L. Sussman. 1986. Allele frequency distribution of two highly polymorphic DNA sequences in three ethnic groups and its application to the determination of paternity. American Journal of Human Genetics. 39:489-501. 24. Benn, P., L. Soper, A. Eisenberg, T. Silver, M. Coleman, B. Caccapaglia, L. Bennett, M. Baird, M. Silverstein, C. Berger, and B. Bernhardt. 1987. Utility of molecular genetic analysis of BCR rearrangement in the diagnosis of chronic myeloid leukemia. Cancer Genetics and Cytogenetics. 29:1-7. 25. Soper, L., B. Bernhardt, A. Eisenberg, B. Caccapaglia, L. Bennett, M. Baird, and R. Silver. 1987. Clonal immunoglobulin gene rearrangements in chronic lymphocytic leukemia: A correlative study. American Journal of Hematology. 27:257-264. 26. Baird, M., M. Clyne, E. Meade, L. Ratzlaff, G. Smalls, K. Wexler, P. Benn, I. Balazs, and J. Glassberg. 1988. The application of DNA-Print for the estimation of paternity. Advances in Forensic Haemogenetics 2. pp 354-358. 27. Baird, M., A. Giusti, E. Meade, M. Clyne, R. Shaler, P. Benn, I. Balazs, and J. Glassberg. 1988. The application of DNA-Print for identification from forensic biological materials. Advances in Forensic Haemogenetics 2. pp 396-402. 28. Balazs, I., M. Baird, M. Clyne, and E. Meade. 1989. Human population genetic studies of five hypervariable DNA loci. American Journal of Human Genetics. 44:182-190. 29. McNally, L., R. Shaler, M. Baird, I. Balazs, P. DeForest, and L. Kobilinsky. 1989. Evaluation of deoxyribonucleic acid (DNA) isolated from human bloodstains exposed to ultraviolet light, heat, humidity, and soil contamination. Journal of Forensic Sciences. 34:1059-1069. 30. McNally, L., R. Shaler, M. Baird, I. Balazs, L. Kobilinsky, and P. DeForest. 1989. The effects of environment and substrata on deoxyribonucleic acid (DNA): The use of casework samples from New York City. Journal of Forensic Sciences. 34:1070-1077. 31. Baird, M. 1989. Quality Control and Quality Assurance. In DNA Technology and Forensic Science. Edited by Ballantyne, J., Sensabaugh, G., and Witkowski, J. Banbury Report 32. pp 175 - 190. Cold Spring Harbor Laboratory Press. New York. Exhibit B Page 96 of 188 Curriculum Vitae Michael L. Baird, Ph.D. Page 6 of 7 32. McNally, L., M. Baird, K. McElfresh, A. Eisenberg, and I. Balazs. 1990. Increased migration rate observed in DNA from evidentiary material precludes the use of sample mixing to resolve forensic cases of identity. Applied and Theoretical Electrophoresis. 1:267-272. 33. Baird, M., K. McElfresh, L. McNally. L. Bennett, J. Coleman, D. Vining, J. Sgueglia, M. Keel, L. Galbreath, R. Cunningham, and I. Balazs. Analysis of Case work smaples by single locus VNTR polymorphisms. In Advances in Forensic Haemogenetics 3. Edited by Polesky, H. and Mayr, W. pp 88 - 91. Springer-Verlag, Berlin. 34. Balazs, I., M. Baird, K. McElfresh, and J. Udey. 1990. Hardy-Weinberg equilibrium analysis of DNA polymorphic loci that exhibit a continuous distribution of fragment sizes. In Advances in Forensic Haemogenetics 3. Edited by Polesky, H. and Mayr, W. pp 71 - 74. 35. Balazs, I., M. Baird, K. McElfresh, and R. Shaler. 1990. Experimental techniques for the isolation and analysis of DNA from forensic materials. In DNA Forensic Science Theory, Techniques and Applications. Edited by Robertson, J., Ross, A., and Burgoyne, L. pp 60 -73. Ellis Horwood. New York. 36. Baird, M., I. Balazs, and K. McElfresh. 1990. Examination of Forensic Biological Evidence by DNA Print Analysis. In DNA and Other Polymorphisms in Forensic Science. Edited by H. Lee and R. Gaensslen. pp 61 - 75. Year Book Medical Publishers, Inc. Chicago. 37. Baird, M. 1990. Analysis of Forensic DNA Samples by Single Locus VNTR Probes. In Forensic DNA Technology. Edited by M. Farley and J. Harrington. pp 39 -49. Lewis Publishers, Inc. Michigan. 38. Baird, M. 1991. The Search for Truth in DNA. Invited Editorial. The New Biologist. 3:527-529. 39. Baird, M. 1993. Quality Control in DNA Profiling Tests. in Molecular Biology and Pathology. Edited by D. Farcus. pp 201 - 215. Academic Press, Inc. New York. 40. Baird, M. 1996. Use of DNA Identification for Forensic and Paternity Analysis. Journal of Clinical Laboratory Analysis. Wiley-Liss, New York, Volume 10, Issue 6, pp 350-358. 41. Baird, M. 1997. DNA Profiling: Laboratory Methods. In Modern Scientific Evidence. D. Faigman, D. Kaye, M. Saks, and J. Sanders, Eds. West Publishing Company, St. Paul, MN. 42. Baird, M. 1998. Use of the AmpliType PM + HLA DQA1 Amplification and Typing Kits for Identity Testing. In Forensic DNA Profiling Protocols. P. Lincoln and J. Thomson, Eds. Humana Press. Totowa, New Jersey. Exhibit B Page 97 of 188 Curriculum Vitae Michael L. Baird, Ph.D. Page 7 of 7 43. Reid, T., D. Ingala, C. Kraemer, W. Dage, C. Dieckhoner, J. Forman, D. Hodge, K. Johnson, C. Oatman, H. Schlotman, C. Schuh, and M. Baird. 2003. Distribution of HUMACTBP22 (SE33) Alleles in Three north American Population. Journal of Forensic Sciences. 48:1422-1423. 44. Reid, T, C. Wolf, C. Kraemer, S. Lee, M. Baird, R. Lee. 2004. Specificity of Sibship determination using the ABI Identifiler Multiplex System. Journal of Forensic Sciences. 49:1262-1264. 45. Peterson, J. W., T. Reid, C. Kraemer, D. Ingala, M. Baird, S. Lee, and R. Lee. 2005. Distribution of Penta B, Penta C, and Penta E Alleles in Asian, Black, Caucasian, and Hispanic Populations. Journal of Forensic Sciences. 50:966-968. 46. Allen, R. W., J. Fu, T. M. Reid, M. Baird. 2007. Considerations for the interpretation of STR results in cases of questioned half-sibship. Transfusion. 47:515-519. 47. Reid, T. M., J. W. Peterson, M. L. Baird, S. C. Lee, and R. F. Lee. 2008. The Use of Supplemental STR Loci for Resolving Difficult Family Relationship Cases. Forensic Science International: Genetics Supplement Series. 1:520-521. 48. Reid, T. M., M. L. Baird. J. P. Reid, S. C. Lee, and R. F. Lee. 2008. Use of Sibling Pairs to Determine the Familial Searching Efficiency of Forensic Databases. Forensic Science International: Genetics. 2:340-342. Exhibit B Page 98 of 188 Curriculum Vitae Debra Davis, Ph.D. Page 1 of 4 CURRICULUM VITAE DEBRA DAVIS, PH.D. EDUCATION M.B.A. – Finance 2001 University of Cincinnati Cincinnati, OH Ph.D. - Biomedical Sciences (Molecular Genetics) 1993 Wright State University Dayton, OH B.S. – Biology 1987 University of Cincinnati Cincinnati, OH PROFESSIONAL EXPERIENCE Laboratory Director 2012 - Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Laboratory Director 2007 - 2012 Orchid Cellmark Inc. Dayton, OH Associate Laboratory Director 1998 - 2007 Orchid Cellmark Inc. Dayton, OH PROFESSIONAL AFFILIATIONS Certification of Qualification New York State Department of Health: Laboratory Director for Parentage /Identity Testing and DNA Testing (2004 to present) AABB (American Association of Blood Banks) Member since 1998 Member AABB Relationship Testing Standards Subcommittee 2010-2010 Exhibit B Page 99 of 188 Curriculum Vitae Debra Davis, Ph.D. Page 2 of 4 Member AABB Assessor Program 2007-Present POST DOCTORAL EDUCATION Specialized Training in Basic Population Genetics and Forensic Statistics. 14th International Symposium on Human Identification (2003) Postdoctoral Research Fellow, Department of Internal Medicine, Division of Cardiology, University of Cincinnati Medical Center, Cincinnati, Ohio Supervisors: Muthu Periasamy, Ph.D. and Michael Ritchie, M.D. “Overexpression of the SR Ca2+ ATPase in transgenic mice” *Performed both RFLP and PCR genotype analysis of transgenic mice (1996 – 1998) 1993-1996 Postdoctoral Research Assistant, Department of Internal Medicine, Division of Cardiology, University of Cincinnati Medical Center, Cincinnati, Ohio Supervisors: Muthu Periasamy, Ph.D. “Transcriptional regulation of the cardiac/slow-twitch muscle SR Ca2+ ATPase (SERCA2) gene. (1993 – 1996) GRADUATE RESEARCH/TEACHING EXPERIENCE Graduate Research Assistant, Department of Biochemistry, Wright State University, Dayton, Ohio (1987-1993) Supervisor: John Paietta, PhD. “Molecular Characterization of the arylsulfatase gene of Neurospora crassa.” Graduate Teaching Assistant, Undergraduate Biology Laboratory, Wright State University, Dayton, Ohio. (1998) Graduate Teaching Assistant, Honors Biology Laboratory, Wright State University, Dayton, Ohio (1989) Graduate Teaching Assistant, Clinical Chemistry (lecture and laboratory) Wright State University, Dayton, Ohio (1989) Research Support: Individual National Research Service Award (NRSA) Postdoctoral Fellowship, “Molecular analysis of SR Ca2+ ATPase gene expression.” 3-yrs./ ($25,600, 26,900, 28,900) August 1, 1995- July 31, 1998 American Heart Association, Postdoctoral Fellowship, “Transcriptional regulation of the cardiac SR Ca2+ ATPase gene.” 1-yr./ ($30,000) July 1, 1995- June 30, 1996 ***declined Exhibit B Page 100 of 188 Curriculum Vitae Debra Davis, Ph.D. Page 3 of 4 INVITED SPEAKER 12th International Symposium on Human Identification- Speaker Paternity Section October 2001 “Interesting Cases / Obstacles in Parentage Testing” Illinois Family Support Association’s Twentieth Annual Members’ Meeting and Conference – Speaker October 2008 “DNA Testing” Louisiana Support Enforcement Association 2009 Training Conference March 11, 2009 Workshop “Utilization of Paternity DNA Testing in Court: The Goof, The Bad and The Unacceptable.” Prosecuting Attorneys of Michigan 2010 Meeting and Conference. March 18, 2010 Workshop “DNA Testing”. Eastern Regional Child Support Association 2010 Meeting and Conference. May 4,2010 Workshop Speaker “DNA Testing”. Indiana Child Support Enforcement 2010 Meeting and Conference. June 3, 2010 Workshop Speaker “ DNA Testing”. PUBLICATIONS D.L. Baker and Paietta J.V. Characterization of the arylsulfatase gene of Neurospora crassa. FASEB Journal, 5, 6694 (1991). D.L. Baker and Paietta J.V. Analysis of the regulated expression of the Neurospora crassa arylsulfatase gene. Abstracts of the General Meeting of the American Society for Microbiology, 1953 (1992). D.L. Baker, Shabbeer J., Larsen J., Walsh R.A., and Periasamy, M. Characterization of multiple cis-acting elements regulating SERCA2 expression in cardiac and skeletal muscle cells. J Cellular Biochemistry. Suppl. 18D: W201 (1994). D.L. Baker, Aria M., Matsui h., Sukovich D., Shabbeer J., Dave V., Walsh RA., and Periasamy M. Regulation of sacroplasmic reticulum gene expression during cardiac hypertrophy and heat failure. (in Dhalla W.S., Singal P.K. Beamlish R.E., eds.) Heart Hypertrophy and Failure, Kluwer Academic Publishers, Boston. (1995). Baker, Dave V., Reed T., and Periasamy M. Multiple SP1 binding sites in the cardiac/slow- twitch muscle Ca2+ ATPase (SERCA2) gene promoter are required for expression in Sol8 muscle cells. J Biol. Chem. 271: 5921-5928(1996). D.L. Baker, Dave V., Reed T., and Periasamy M. SP1 plays an essential role in the transcriptional regulation of the SERCA gene. Keystone Symposia: Molecular Biology of the Cardiovascular System. 200 (1996). T. Reed, Baker DL, Dave V., and Periasamy M. Muscle specific transcriptional regulation of the Exhibit B Page 101 of 188 Curriculum Vitae Debra Davis, Ph.D. Page 4 of 4 cardiac/slow-twitch SERCA2 gene. Circulation. 94:1324 (1996). D.L. Baker, .Loukianov E, Bhagwat A, Hoit B, Walsh RA, and Periasamy M. Overexpression of the SR Ca2+ in transgenic mouse hearts. ISHR Meeting, Vancouver, British Columbia, Canada, (1997) D.L. Baker, Dave V., Reed T., and Periasamy M. A Novel E-box/AT-rich element is required for the muscle specific expression of the sarcoplasmic reticulum Ca2+ ATPase (SERCA2) gene . Nucleic acids Res. 26:1092-1098 (1998). D.L. Baker, Reed T, Grupp IL, Grupp G, Bhagwat A, Hoit B, Walsh RA, and Periasamy M. Overexpression of the cardiac SR Ca2+ ATPase increases myocardial performance. American Heart Association—70th session, (1997). Rishi AK, Wu JT, Yu M, Belani JP, Fontana JA, Baker DL, Periasamy M, and Hussain A. Regulation of the sacro/endoplasmic reticulum Ca2+ transport ATPase in thapsigargin- resistant Syrian hamster smooth muscle cells. Nucleic acids Res. (1998). Loukianov E, Ji Y, Grupp IL, Kirkpatrick D, Baker DL, Loukianova T, Grupp G, Lytton J, Walsh RA, Periasamy M. Enhanced myocardial contractility and increased Ca2+ transport function in transgenic hearts expressing the fast-twitch skeletal muscle sarcoplasmic reticulum Ca2+ ATPase. Circ.Res. 83: 889-897 (1998). Loukianov E, Ji Y, Baker DL, Reed T., Babu, J, Loukianov T, Greene A, Shull G, and Periasamy M. Sarco(endo)plasmic reticulum Ca2+ ATPase isoforms and their role in muscle physiology and pathology. “Cardiac sarcoplasmic reticulum function and regulation of contractility.” Annuals of New York Academy of Science (1998). D.L. Baker, Grupp IL, Ji Y, Reed T, Loukianov E, Grupp G, Bhagwat A, Hoit B, Walsh RA, and Periasamy M. Targeted overexpression of the sarcoplasmic reticulum Ca2+ ATPase increases cardiac contractility in transgenic mouse hearts Circ. Res. 83:1205-1214 (1998). Exhibit B Page 102 of 188 Curriculum Vitae John Peterson, Ph.D. Page 1 of 5 CURRICULUM VITAE JOHN PETERSON, PH.D. EDUCATION Ph.D. – Biomedical Sciences 2003 Wright State University Dayton, Ohio B.S. – Biological Sciences 1994 Wright State University Dayton, Ohio PROFESSIONAL EXPERIENCE Laboratory Director 2017 - Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Associate Laboratory Director 2012 - 2017 DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Forensic Scientist 2007 – 2012 Marion County Forensic Services Agency Indianapolis, IN Assistant Laboratory Director 2003 - 2007 DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Laboratory Technician 1995 – 1996 Wright State University Dayton, OH PROFESSIONAL AFFILIATIONS AABB - Advancing Transfusion and Cellular Therapies Worldwide (formerly the American Association of Blood Banks) ASM - American Society for Microbiology AAFS - American Academy of Forensic Sciences Exhibit B Page 103 of 188 Curriculum Vitae John Peterson, Ph.D. Page 2 of 5 SPECIALIZED TRAINING Quality Assurance Standards/Auditor Training January 2011 Federal Bureau of Investigation, Laboratory Division Mixture Interpretation: Principles, Protocol, & Practices October 2010 San Antonio, TX Extensive training in DNA analysis for forensics 2007 - 2008 Indianapolis-Marion County Forensic Services Agency Indianapolis, IN Courtroom Training Course March 2008 Indianapolis-Marion County Forensic Services Agency DNA Mixture Interpretation: Principles and Practice in Component February 2008 Deconvolution and Statistical Analysis. Washington, D.C. Statistics Theory October 2007 Los Angeles, CA Hair Examination for DNA Analysis May 2007 Indianapolis, IN Instructor: Max Houck Extensive training and experience in DNA-based veterinary relationship 2004 – 2007 and veterinary disease/trait testing DNA Diagnostics Center, Fairfield, OH Extensive training and experience in DNA-based human relationship 2003 - 2007 testing DNA Diagnostics Center, Fairfield, OH Understanding DNA Statistics September 2005 Dallas, TX CONFERENCES ATTENDED American Academy of Forensic Sciences 68th Annual Meeting (2016) Attended Considerations for Implementing Next Generation Sequencing (NGS) Technologies into a Forensics Laboratory workshop. Chair: Timothy McMahon, PhD Las Vegas, NV American Academy of Forensic Sciences 67th Annual Meeting (2015) Exhibit B Page 104 of 188 Curriculum Vitae John Peterson, Ph.D. Page 3 of 5 Attended Obtaining Successful DNA Profiles From Challenging Samples workshop. Chair: Sudhir Sinha, PhD Orlando, FL American Academy of Forensic Sciences 66th Annual Meeting (2014) Attended Applications of Next Generation Sequencing in Forensic DNA Analysis workshop. Chair: Jaiprakash Shewale, PhD Seattle, WA American Academy of Forensic Sciences 65th Annual Meeting, Washington, DC (2013) American Academy of Forensic Sciences 63rd Annual Meeting, Chicago, IL (2011) 21st International Symposium on Human Identification (2010) Attended Mixture Interpretation: Principles, Protocol, & Practices workshop; Chairs: John Butler, PhD and Robin Cotton, PhD Attended HITA/AABB workshop on SNP Analysis for Identification, Ancestry, Genealogy, and Relationships workshop; Chair: Thomas Reid, PhD, San Antonio, TX American Academy of Forensic Sciences 61st Annual Meeting; Denver, CO (2009) American Academy of Forensic Sciences 60th Annual Meeting (2008) Attended DNA Mixture Interpretation: Principles and Practice in Component Deconvolution and Statistical Analysis workshop. Chair: John Butler, PhD, Washington, DC 18th International Symposium on Human Identification (2007) Attended Statistics Theory workshop Instructors: Bruce Budowle, PhD and George Carmody, PhD Attended Generating DNA Profiles from Difficult Samples workshop. Attended HITA/AABB immigration issues and DNA testing workshop. Chair: Michael Baird, PhD, Los Angeles, CA 3rd International Conference: Advances in Canine and Feline Genomics and Inherited Diseases, Davis, CA (2006) 16th International Symposium on Human Identification (2005) Attended Understanding DNA Statistics workshop; Instructors: John Planz, PhD and Arthur Eisenberg, PhD Dallas, TX. PUBLICATIONS 1. Reid TM, Peterson JW, Baird ML, Lee SC, Lee RF (2008) The use of supplemental STR loci for resolving difficult family relationship cases. Forensic Sciences International: Genetics Supplement Series. 1:520-521. Exhibit B Page 105 of 188 Curriculum Vitae John Peterson, Ph.D. Page 4 of 5 2. Peterson JW, Reid TM, Kraemer CK, Ingala DA, Baird ML, Lee SC, and Lee RF (2005) Distribution of Penta B, Penta C, and Penta E alleles in Asian, Black, Caucasian, and Hispanic populations. Journal of Forensic Sciences. 50: 966-968. 3. Peterson JW, Wilson BA, Hull BE, Bigley NJ (2000) Pasteurella multocida toxin effects on cytoskeleton and cell division in primary cell cultures. B-154. American Society for Microbiology 2000 General Meeting. Los Angeles, CA. 4. Ho M, Wilson BA, Peterson JW (1999) Bacterially expressed Raf-1 catalytic domain is highly associated with GroEL. Journal of the Chinese Chemical Society. 46: 735-742. 5. Peterson JW, Wilson BA, Bae SC, Ho M (1998) Bacterially expressed catalytic domain of c-Raf-1 is tightly associated with GroEL. FASEB J. 12:A1409. American Society for Biochemistry and Molecular Biology 1998 General Meeting. Washington, D.C. 6. Mauer MJ, Peterson JW, Manzon JD, and Bigley NJ (1997) Changes in cell adhesion molecules early in picornavirus infection. FASEB J. 11:A120. American Association for Immunologists 1997 General Meeting. San Francisco, CA. 7. Trelease RB, Raker JA, Peterson JW, Henderson RA, Park J, and Bigley, NJ (1997) Qualitative process modeling of differences in cytokine production early in picornavirus infection. FASEB J. 11:A709. American Association for Immunologists 1997 General Meeting. San Francisco, CA. PRESENTATIONS 1. Reid TM, Peterson JW, Baird ML, Lee SC, Lee RF (2007) The use of supplemental STR loci for resolving difficult family relationship cases. 22nd Congress of the International Society for Forensic Genetics. Copenhagen, Denmark. 2. Kraemer CK, Reid TM, Hodge DM, Peterson JW, Baird ML, Lee SC, Lee RF (2006) The use of “mini” STR loci for resolving difficult relationship cases. 17th International Symposium on Human Identification. Nashville, TN. 3. Peterson JW, Baird ML, Reid TM, Kraemer CK, Hodge DM, Schuh CM, Dieckhoner CL, Ahmed MB, Lee SC and Lee RF (2005) DDC Plex: The use of additional STR loci for solving difficult parentage and sibship tests. 16th International Symposium on Human Identification. Dallas, TX. 4. Peterson JW, Wilson BA, Bae SC, and Ho M (1998) Bacterially expressed catalytic domain of c-Raf-1 is associated with GroEL. 6th Annual Molecular Biology Retreat. Wright State University, Dayton, OH. 5. Wilson BA, Zhu X, Ho M, Vallance JE, Ponferrada VG, and Peterson JW (1997) The N- terminus of Pasteurella multocida toxin uncouples the Gq!-protein-mediated IP3 Exhibit B Page 106 of 188 Curriculum Vitae John Peterson, Ph.D. Page 5 of 5 signaling pathway in Xenopus oocytes. Cold Spring Harbor Laboratory Meeting on Microbial Pathogenesis and Host Defense. Cold Spring Harbor, NY. 6. Peterson JW, Ho M, and Wilson, BA (1997) Expression and purification of bacterially expressed c-Raf-1 catalytic domain. 5th Annual Molecular Biology Retreat. Wright State University, Dayton, OH. 7. Wilson BA, Zhu XJ, Ponferrada VG, Peterson JW, Vallance JE, Ho MF, and Lu L (1996) Pasteurella multocida toxin activates the IP3 pathway in Xenopus oocytes via Gq- protein- coupled phospholipase C-"-1. Gordon Research Conference on Microbial Toxins and Pathogenicity. Andover, NH. 8. Wilson BA, Zhu XJ, Ponferrada VG, Peterson JW, Vallance JE, Ho MF, and Lu L (1996) Pasteurella multocida toxin activates the IP3 pathway in Xenopus oocytes via Gq protein-coupled phospholipase C-"-1. 3rd Midwest Microbial Pathogenesis Conference. Madison, WI. Exhibit B Page 107 of 188 Curriculum Vitae Joy Johnson, Ph.D. Page 1 of 3 CURRICULUM VITAE JOY JOHNSON, PH.D. EDUCATION Ph.D. – Microbial Genetics 1987 Wright State University Dayton, Ohio BS – Biology (summa cum laude) 1981 Georgetown College Georgetown, Kentucky PROFESSIONAL EXPERIENCE Associate Laboratory Director 2012 - Present DNA Diagnostics Center (DDC) Fairfield, OH Associate Laboratory Director 2007 - 2012 Orchid Cellmark Inc Dayton, Ohio Adjunct Faculty 2006 - 2007 Biological Sciences Department Sinclair Community College Dayton, Ohio Associate Laboratory Director 1999 - 2006 Orchid Cellmark Inc. Dayton, Ohio Research Associate 1997 - 1999 Biological Sciences Department Wright State University Research Microbiologist 1988 - 1997 Department of Veterans Affairs Medical Center Research Service Dayton Facility Exhibit B Page 108 of 188 Curriculum Vitae Joy Johnson, Ph.D. Page 2 of 3 Research Associate 1987 – 1988 US Environmental Protection Agency Cincinnati, Ohio Lab Teaching Assistant 1982 - 1983 Department of Biology Department of Microbiology and Immunology Wright State University Lab Assistant 1987 - 1981 Departments of Biology, Foreign Languages, Chemistry Georgetown College PROFESSIONAL AFFILIATIONS American Society for Microbiology Biotechnology Club, Cincinnati, Ohio Laboratory Animal Care and Use Committee Wright State University Certification of Qualification New York State Department of Health: Laboratory Director for Parentage /Identity Testing and DNA PUBLICATIONS Warren, R. L., N. R. Baker, J. Johnson, and M. J. Stapleton. 1985. Selective inhibition of the accumulation of extracellular proteases of Pseudomonas aeruginosa by gentamicin and tobramycin. Antimicrob. Agents Chemother. 27:468-472. Sangodkar, U. M. X., T. Aldrich, R. A. Haugland, J. Johnson, R. K. Rothmal, P. J. Chapman, and A. M. Chakrabarty. 1989. Molecular basis of biodegradation of chloroaromatic compounds. Acta. Biotechnol. 9:301-316. Johnson, J., A. A. Branstrom, and R. L. Warren. 1991. The effects of FP2 and a mercury resistance plasmid from Pseudomonas aeruginosa strain PA103 on exoenzyme production. J. Clin. Microbiol. 29:940-944. Yokokawa, K., J. Johnson, M. Kohno, A. K. Mandal, M. Yanagisawa, T. Horio, K. Yasunari, and T. Takeda. 1994. Phosphoinositide turnover signaling stimulated by ET-3 in endothelial cells from spontaneously hypertensive rats. Am. J. Physiol. 267 (Regulatory Integrative Comp. Physiol. 36): R635-R644. Exhibit B Page 109 of 188 Curriculum Vitae Joy Johnson, Ph.D. Page 3 of 3 ABSTRACTS and PRESENTATIONS Johnson, J., K. S. Jagger, and R. L. Warren. Influence of iron on exoproducts of Pseudomonas aeruginosa. Ohio Branch Amer. Soc. Microbiol., Athens, Ohio, 1982. Johnson, J., J. Naglich, and K. S. Jagger. Detection of Pseudomonas proteases in sputum samples from Cystic Fibrosis patients. 84th Nat’l Amer. Soc. Microbiol., St. Louis, Missouri, 1984. Johnson, J. and R. L. Warren. Insertion of transposon Tn7 into the chromosome of Pseudomonas aeruginosa. 85th Nat’l Amer. Soc. Microbiol., Las Vegas, Nevada, 1985. Johnson, J. and R. L. Warren. Plasmid control of exoenzymes in Pseudomonas aeruginosa. 87th Nat’l Amer. Soc. Microbiol., Atlanta, Georgia, 1987. Haugland, R. A., J. Johnson, U. M. X. Sangodkar, P. R. Sferra, A. Kornel, and A. M. Chakrabarty. Characterization of 2,4,5-T degradative genes in Pseudomonas cepacia strain AC1100 and spontaneous mutants. EPA Fourteenth Annual Research Symposium. Land Disposal, Remedial Action, Incineration and Treatment of Hazardous Waste, Cincinnati, Ohio, 1988. Branstrom, A. A., R. L. Warren, J. Johnson, and T. B. Sorg. Cloning and mutagenesis of a Haemophilus influenzae type b gene involved in the breakdown of NAD. 91st Nat’l Amer. Soc. Microbiol., Dallas, Texas, 1991. Johnson, J. and T. B. Sorg. Protection studies using polyclonal rabbit antiserum against Haemophilus influenzae NAD pyrophosphatase. 94th Nat’l Amer. Soc. Microbiol., Las Vegas, Nevada, 1994. Arlian, L.G. and J. Johnson. Secretion of IL6 by fibroblasts stimulated with an extract of the mite, Sarcoptes scabiei. The American Society of Tropical Medicine and Hygiene, San Juan Puerto Rico, October 1998. Arlian, L.G., J. Johnson and M. Morgan. Cytokine production by fibroblasts in response to Sarcoptes scabiei. Entomological Society of America, Las Vegas, Nevada, November 1998. GRANTS Johnson, J. and T. B. Sorg. Production of monoclonal antibodies to NAD pyrophosphatase of Haemophilus influenzae. $4000. Wright State University Biomedical Research Seed Grant, 1989. Exhibit B Page 110 of 188 Curriculum Vitae Yong Ji, M.D., Ph.D. Page 1 of 4 CURRICULUM VITAE YONG JI, M.D., Ph.D. EDUCATION Ph.D. - Cardiovascular Pathophysiology 1994 Beijing Medical University, P. R. China M.S. - Gastrointestinal Pathophysiology, 1989 Hebei Medical College, P.R. China M.D. -Medicine 1986 Hebei Medical College, P.R. China PROFESSIONAL EXPERIENCE Assistant Laboratory Director 2014 – Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Adjunct Assistant Professor 2007 - 2014 Department of Pathology and Laboratory Medicine University of Cincinnati Cincinnati, OH Adjunct Assistant Professor 2006 - 2007 Department of Genome Science University of Cincinnati Cincinnati, OH Senior Research Scientist 2002 - 2006 Department of Genome Science University of Cincinnati Cincinnati, OH Senior Research Scientist 2000 - 2002 Department of Molecular and Cellular Physiology University of Cincinnati Cincinnati, OH Exhibit B Page 111 of 188 Curriculum Vitae Yong Ji, M.D., Ph.D. Page 2 of 4 Postdoctoral Fellow, Molecular Cardiology 1997 - 2000 Department of Internal Medicine University of Cincinnati Cincinnati, OH Associate Professor 1996 - 1997 Department of Pathophysiology Beijing Medical University, P.R. China. Assistant Professor 1994 - 1996 Department of Pathophysiology Beijing Medical University, P.R. China 7/1989–7/1991 Instructor 1989 - 1991 Department of Pathophysiology Hebei Medical College, P.R. China Teaching & Research Assistant 1987 - 1989 Department of Pathophysiology Hebei Medical College, P.R. China PROFESSIONAL AFFILIATIONS Member, Basic Cardiovascular Sciences Scientific Council of the American Heart Association Member, International Society for Heart Research AWARDS AND HONORS 2011-2015 Co-Investigator, NIH/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) RO1 2010 Recipient, University of Cincinnati Faculty Research Support Grant 2007 Recipient, University of Cincinnati Faculty Research Support Grant 2004-2006 Recipient, American Heart Association (Ohio Valley) Beginning Grant-In-Aid 2001-2003 Recipient, American Heart Association (Ohio Valley) Beginning Grant-In-Aid 1999-2001 Recipient, American Heart Association (Ohio Valley) Postdoctoral Fellowship 1994 Young Investigator Award, the Third Shock Conference of China Pathophysiology Society 1993 Merit Award for Academic Excellence of Ph.D. candidate, Graduate School, Beijing Medical University 1987 Excellent Graduate Student Award, Graduate School, Hebei Medical College 1986 Medical School Valedictorian, Hebei Medical College Exhibit B Page 112 of 188 Curriculum Vitae Yong Ji, M.D., Ph.D. Page 3 of 4 PUBLICATIONS 1. Yong Ji, Yasuhisa Sakata, Xiaoming Li, Chao Zhang, Qing Yang, Min Xu, Armin Wollin, Wolfgang Langhans and Patrick Tso. Lymphatic diamine oxidase secretion stimulated by fat absorption is linked with histamine release. Am J Physiol Gastrointest Liver Physiol. 2013; 304(8):G732-40. 2. Yong Ji, Yasuhisa Sakata, Qing Yang, Xiaoming Li, Min Xu, and Patrick Tso. Activation of rat intestinal mucosal mast cells by fat absorption. Am J Physiology 2012; 302: G1292-1300. 3. Yong Ji, Yasuhisa Sakata, and Patrick Tso. Nutrient-induced inflammation in the intestine. Curr Opin Clin Nutr Metab Care 2011; 14:315-321. 4. Yang L, Li X, Yong Ji, Kohan AB , Wang DQ, Howles PN, Hui DY, Lai J, Tso P. Effect of Ezetimibe on incretin secretion in response to intestinal lipid ingestion. Am J Physiol Gastrointest Liver Physiol. 2010; 299 (5):G1003-11. 5. Yong Ji, Wen Zhao, Bailing Li, Jaime Desantiago, Eckard Picht, Marcia A. Kaetzel, Jo El J. Schultz, Evangelia G. Kranias, Donald M. Bers, John R. Dedman. Targeted inhibition of sarcoplasmic reticulum CaMKII activity results in alterations of Ca2+ homeostasis and cardiac contractility. Am J Physiol Heart Circ Physiol. 2006; 290:H599-H606. 6. Yanfang Xu, Zhao Zhang, Valeriy Timofeyev, Dipika Sharma, Danyan Xu, Dipika Tueja, Peihong Dong, Gias Uddin Ahmmed, Yong Ji, Gary E. Shull, Muthu Periasamy and Nipavan Chiamvimonvat. The effect of intracellular Ca2+ on cardiac K+ channel expression and activity: novel insights from genetically altered mice. J Physiol 2005; 562: 745-758. 7. Yong Ji, Bailing Li, Thomas Reed, John Lorenz, Marcia A. Kaetzel and John R. Dedman. Targeted inhibition of Ca2+/calmodul;in-dependent protein kinase II in cardiac longitudinal sarcoplasmic reticulum results in decreased phospholamban phosphorylation at Threonine 17. J Biol Chem 2003; 278: 25063-25071. 8. Wen Zhao, Konrad F. Frank, Guoxiang Chu, Mike Gerst, Albert Schmidt, Yong Ji, Muthu Periasamy, Evangelia G.Kranias. Combined phospholamban ablation and SERCA1a overexpression result in a new hyperdynamic cardiac state. Cardiovas Res 2003; 57: 71-81. 9. LinWang Dong, Liling Wu, Yong Ji, Maw-shung Liu. Impairment of the ryanodine-sensitive calcium release channels in the cardiac sarcoplasmic reticulum and its underlying mechanism during the hypodynamic phase of sepsis. Shock 2001;16:33-9. 10. Liling Wu, Yong Ji, LinWang Dong, Maw-shung Liu. Calcium uptake by sarcoplasmic reticulum is impaired during the hypodynamic phase of sepsis in the rat heart. Shock 2001 15:49-55. 11. M. Jane Lalli, Yong Ji, Katsuji Hashimoto, Gopal J. Babu, Darryl Kirkpatrick, Evgeny Loukianov, Richard A. Walsh, Mark Sussman, Eduardo Marban, Muthu Periasamy. Sarcoplsmic reticulum Ca2+ ATPase (SERCA) 1a structurally substitutes for SERCA2a in the cardiac sarcoplasmic reticulum and increases cardiac Ca2+ handling capacity. Circ Res 2001; 89:160- 167. Exhibit B Page 113 of 188 Curriculum Vitae Yong Ji, M.D., Ph.D. Page 4 of 4 12. Thomas D. Reed, Jegardeesh Babu, Yong Ji, Alla Zilberman, Mark Ver Heyen, Frank Wuytack, and Muthu Periasamy. The expression of SR calcium transport ATPase and the Na+/Ca2+ exchanger are antithetically regulated during mouse cardiac development and in hypo/hyperthyroidism. J Mol Cell Cardiol 2000; 32:453-464. 13. Yong Ji, M. Jane Lalli, Gopal J Babu, Yanfang Xu, Darryl Kirkpatrick, Lynne Liu, Thomas D. Reed, Nipavan Chiamvimonvat, Richard A Walsh, Gary E Shull, and Muthu Periasamy. Disruption of a single copy of SERCA2 gene results in altered Ca2+ homeostasis and myocyte contractility. J Biol Chem. 2000; 275: 38073-38080 14. Adam L. Green, M. Jane Lalli, Yong Ji, Gopal Jegadeesh Babu, Ingrid Grupp, Mark Sussman, and Muthu Periasamy. Overexpression of SERCA 2b in the heart leads to an increase in SR calcium transport function and increased cardiac contractility. J Biol Chem. 2000; 275:22742-22747 15. Muthu Periasamy, Thomas D. Reed, Lynne H. Liu, Yong Ji, Evgeny Loukianov, Richard Paul, Michelle L. Nieman, Tara Riddle, John J. Duffy, Thomas Doetschman, John N. Lorenz, and Gary E. Shull. Impaired cardiac performance in heterozygous mice with a null mutation in the sarco(endo)plasmic reticulum Ca2+-ATPase isoform 2 (SERCA2) gene. J Biol Chem 1999; 274: 2556-2562. 16. Yong Ji, Evgeny Loukianov, Muthu Periasamy. Analysis of SR Ca2+ transport and Ca2+ ATPase enzymatic properties using mouse cardiac tissue homogenates. Anal Biochem 1999; 269: 236-244. 17. Yong Ji, Evgeny Loukianov, Tanya Loukianova, Larry Jones, Muthu Periasamy. SERCA1a can functionally substitute for SERCA2a in the heart. Am J Physiol 1999; 276: H89-H97. 18. Evgeny Loukianov, Yong Ji, Ingrid L. Grupp, Darry L. Kirkpatrick, Debra L. Baker, Tanya Loukianova, Gunter Grupp, Jonathan Lytton, Richard A. Walsh, Muthu Periasamy. Enhanced myocardial contractility and increased Ca2+ transport function in transgenic hearts expressing the fast-twitch skeletal muscle sarcoplasmic reticulum Ca2+-ATPase. Circ Res 1998, 83: 889- 897. 19. Debra Baker, Katsu Hasimoto, Ingrid L. Grupp, Yong Ji, Thomas Reed, Evgeny Loukianov,Gunter Grupp, Ajit Bhagwhat, Brain Hoit, Richard Walsh, Eduardo Marban, Muthu Periasamy. Targeted overexpression of the sarcoplasmic reticulum Ca2+-ATPase increases cardiac performance in transgenic mouse hearts. Circ Res 1998; 83: 1205-1214. 20. Evgeny Loukianov, Yong Ji, Debra Baker, Thomas Reed, Jegardeesh Babu, Tanya Loukianova, Adam Green, Gary E. Shull, and Muthu Periasamy. Sarco(endo)plasmic reticulum Ca2+ ATPase isoforms and their role in muscle physiology and pathology. Ann N Y Acad Sci 1998, 853: 251-259. Exhibit B Page 114 of 188 Curriculum Vitae William Sun, Ph.D. Page 1 of 2 CURRICULUM VITAE WILLIAM SUN, PH.D. EDUCATION Ph.D. University of Alberta 1992 Alberta, Canada M.S. Peking Union Medical College 1984 Beijing, China B.S. Chinese Pharmaceutical University 1982 Nanjing, China PROFESSIONAL EXPERIENCE Associate Laboratory Director 2015 – Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Contractor 2014 – 2015 University of Cincinnati Department of Pathology Cincinnati, OH Research Instructor 2003 – 2008 University of Cincinnati Department of Pathology Cincinnati, OH Research Associate 1998 – 2003 Children’s Hospital Research Foundation Cincinnati, OH Postdoctoral Fellow 1994 – 1998 Children’s Hospital Research Foundation Cincinnati, OH Postdoctoral Fellow 1993 – 1994 University of Alberta Alberta, Canada AWARDS AND HONORS 1987 Ministry of Health of China Award, Ministry of Health, Peoples Republic of China. Exhibit B Page 115 of 188 Curriculum Vitae William Sun, Ph.D. Page 2 of 2 1990 Faculty of Medicine 75th Anniversary Award, University of Alberta, Canada. 1996-1999 Postdoctoral Fellowship, American Heart Association, Ohio-West Virginia affiliate, USA. PUBLICATIONS Mullins ES, Kombrinck KW, Talmage KE, Shaw MA, Witte DP, Ullman JM, Degen SJ, Sun WY, Flick MJ, Degen JL. Genetic elimination of prothrombin in adult mice is not compatible with survival and results in spontaneous hemorrhagic events in both heart and brain. Blood. 2009 Jan 15;113(3):500-1 Lu WJ, Yang Q, Sun WY, Woods SC, D’Alessio D, Tso P. Using the lymph fistula rat model to study the potentiation of GIP secretion by the ingestion of fat and glucose. Am J Physiol Gastrointest Liver Physiol. 2008 May;294(5):G1130-8. Sun, WY, ML Jenkins and SJF Degen. 2002. Rescue of prothrombin-deficiency by transgene expression in mice. Thrombosis and Haemostasis, 88:984-91 Sun, WY, M Burkart, JR Holahan and SJF Degen. 2000. Prothrombin San Antonia: a single amino acid substitution at a factor Xa activation site (Arg320 to His) results in dysprothrombinemia, Genetic determination of a novel mutation: the cause of dysprothrombinemia. Blood, 95:711-14. Muraoka, RS, WY Sun, MC Colbert, SE Waltz, DP Witte, JL Degen, and SJF Degen. 1999. The Ron/STK receptor tyrosine kinase is essential for peri-implantation development in the mouse. J Clin Invest, 103:1227-85. Sun, WY, D Witte, J Degen, M Colbert, M Burkart, K Holmbeck, Q Xiao, T Bugge and S Degen. 1998. Prothrombin deficiency results in embryonic and neonatal lethality in mice. Proc Natl Acad Sci, 95:7597-602. Sun WY, Lo CM, Tso P. The Mechanism of Intestinal Lipid Absorption. In: Textbook of Gastroenterology (5th edition), Yamada T ed. Blackwell Publishing, Oxford, UK: 2008, pp 445-63. Exhibit B Page 116 of 188 Curriculum Vitae Guangyun Sun, Ph.D. Page 1 of 7 CURRICULUM VITAE GUANGYUN SUN, PH.D. EDUCATION Ph.D. - Forensic Biology and Molecular Genetics) 1994 West China University of Medical Sciences, China M.S. - Animal Cytogenetics 1989 Sichuan University, China B.S. – Zoology 1986 Sichuan University, China PROFESSIONAL EXPERIENCE Assistant Laboratory Director 2015 – Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Senior Research Associate 2006 - 2015 Dept.of Environmental Health, University of Cincinnati Cincinnati, OH Research Associate 2001 - 2006 Dept.of Environmental Health, University of Cincinnati Cincinnati, OH Visiting Scholar 1998 - 2001 Dept.of Environmental Health, University of Cincinnati Cincinnati, OH Associate Professor 1996 - 1998 Dept. of Forensic Medicine, West China University of Medical Sciences Chengdu, China Lecturer 1994 - 1996 Dept. of Forensic Medicine, West China University of Medical Sciences Chengdu, China Assistant teacher 1989 - 1994 Dept. of Forensic Medicine, West China University of Medical Sciences Exhibit B Page 117 of 188 Curriculum Vitae Guangyun Sun, Ph.D. Page 2 of 7 Chengdu, China PUBLICATIONS Daniel Woo, Guido J. Falcone,William J. Devan  Guangyun Sun Jonathan Rosand. Meta- Analysis of Genome-Wide Association Studies Identifies 1q22 as a Susceptibility Locus for Intracerebral Hemorrhage. The American Journal of Human Genetics 94, 1–11, April 3, 2014. Olive D. Buhule1, Ryan L. Minster, Nicola L. Hawley, Mario Medvedovic, Guangyun Sun,Satupaitea Viali , Ranjan Deka, Stephen T. McGarvey and Daniel E. Weeks .Stratified randomization controls better for batch effects in 450K methylation analysis: a cautionary tale. Frontier in Genetics, October 2014: Volume 5, Article 354. Nicola L.Hawley,Ryan L.Minster,Daniel E. Weeks , Satupaitea Viali, Muagututia Seuiva Reupena, Guangyun Sun, Hong Cheng, Ranjan Deka and Stephen T. McGarvey . Revalence of Adiposity and Associated Cardiometabolic Risk Factors in the Samoan Genome-Wide Association Study.American Journal of Human Biology, 26:491–501 (2014) Rebekah Karns, Paul Succop, Ge Zhang, Guangyun Sun, Subba R. Indugula1, Dubravka Havas-Augustin3,Natalija Novokmet, Zijad Durakovic, Sanja Music Milanovic, Sasa Missoni, Silvije Vuletic, Ranajit Chakraborty,Pavao Rudan and Ranjan Deka. Modeling Metabolic Syndrome through Structural Equations of Metabolic Traits, Comorbid Diseases, and GWAS Variants. Obesity, (2013) 21, E745-E754. doi:10.1002/oby.2044 Rebekah Karns, Ge Zhang, Guangyun Sun, Subba Rao Indugula, Hong Cheng, Dubravka Havas-Augustin, Natalija Novokmet, Dusko Rudan, Zijad Durakovic, Sasa Missoni, Ranajit Chakraborty, Pavao Rudan, Ranjan Deka . Genome-wide association of serum uric acid concentration: replication of sequence variants in an island population of the Adriatic coast of Croatia. Annals of Human Genetics. 03/2012; 76(2):121-7. Jessica G Woo1, Lisa J Martin, Lili Ding, W Mark Brown, Timothy D Howard, Carl D Langefeld3,Charles J Moomaw, Mary Haverbusch, Guangyun Sun, Subba R Indugula, Hong Cheng, Ranjan Deka and Daniel Woo .Quantitative criteria for improving performance of buccal DNA for high-throughput genetic analysis.. BMC Genetics, 2012, 13:75 Ge Zhang, Rebekah Karns, Guangyun Sun, Subba Rao Indugula, Hong Cheng, Dubravka Havas-Augustin, Natalija Novokmet, Zijad Durakovic, Sasa Missoni, Ranajit Chakraborty, Pavao Rudan, Ranjan Deka. Finding Missing Heritability in Less Significant Loci and Allelic Heterogeneity: Genetic Variation in Human Height. PLoS ONE . 01/2012; 7(12):e51211. DOI:10.1371 Rebekah Karns, Ge Zhang, Nina Jeran, Dubravka Havas-Augustin, Sasa Missoni, Wen Niu, Subba Rao Indugula, Guangyun Sun, Zijad Durakovic, Nina Smolej Narancic, Pavao Rudan, Ranajit Chakraborty, Ranjan Deka . Replication of genetic variants from genome-wide association studies with metabolic traits in an island population of the Adriatic coast of Croatia..European journal of human genetics: EJHG. 03/2011; 19(3):341-6. Exhibit B Page 118 of 188 Curriculum Vitae Guangyun Sun, Ph.D. Page 3 of 7 Ge Zhang, Rebekah Karns, Guangyun Sun, Subba Rao Indugula, Hong Cheng, Dubravka Havas-Augustin, Natalija Novokmet, Dusko Rudan, Zijad Durakovic, Sasa Missoni, Ranajit Chakraborty, Pavao Rudan, Ranjan Deka. Extent of height variability explained by known height-associated genetic variants in an isolated population of the Adriatic coast of Croatia. .PloS one. 01/2011; 6(12):e29475. Ranjan Deka, Daniel L Koller, Dongbing Lai, Subba Rao Indugula, Guangyun Sun, Daniel Woo, Laura Sauerbeck, Charles J Moomaw, Richard Hornung, E Sander Connolly, Guy Rouleau, Irene Meissner, Joan E Bailey-Wilson, John Huston, Robert D Brown, Dawn O Kleindorfer, Matthew L Flaherty, Carl D Langefeld, Tatiana Foroud, Joseph P Broderick . The relationship between smoking and replicated sequence variants on chromosomes 8 and 9 with familial intracranial aneurysm. Stroke: a journal of cerebral circulation., 02/2010; 41(6):1132-7. Karolina Aberg, Feng Dai, Guangyun Sun, Ember D Keighley, Subba R Indugula, Sarah T Roberts, Qi Zhang, Diane Smelser, Satupaitea Viali, John Tuitele, Li Jin, Ranjan Deka, Daniel E Weeks, Stephen T McGarvey .Susceptibility loci for adiposity phenotypes on 8p, 9p, and 16q in American Samoa and Samoa. Obesity (Silver Spring, Md.). 04/2009; 17(3):518-24. Karolina Aberg,Feng Dai,Satupaitea Viali,John Tuitele, Guangyun Sun,Subba Indugula, Ranjan Deka,Daniel E Weeks, Stephen T McGarvey.Suggestive linkage detected for blood pressure related traits on 2q and 22q in the population on the Samoan islands.BMC medical genetics.01/2009; 10:107. Gregory T. Motz, Bryan L. Eppert, Guangyun Sun, Scott C. Wesselkamper,Michael J. Linke, Ranjan Deka, and Michael T. Borchers. Persistence of Lung CD8 T Cell Oligoclonal Expansions upon Smoking Cessation in a Mouse Model of Cigarette Smoke-Induced Emphysema1. The Journal of Immunology 2008 vol. 181 no. 11 8036-804. Karolina Aberg, Feng Dai, Guangyun Sun, Ember Keighley, Subba Rao Indugula, Linda Bausserman, Satupaitea Viali, John Tuitele, Ranjan Deka, Daniel E Weeks, Stephen T McGarvey. A genome-wide linkage scan identifies multiple chromosomal regions influencing serum lipid levels in the population on the Samoan islands. Journal of lipid research. 08/2008; 49(10):2169-78. Karolina Aberg, Guangyun Sun, Diane Smelser, Subba Rao Indugula, Hui-Ju Tsai, Matthew S Steele, John Tuitele, Ranjan Deka, Stephen T McGarvey, Daniel E Weeks. Applying novel genome-wide linkage strategies to search for loci influencing type 2 diabetes and adult height in American Samoa. Human biology. 05/2008; 80(2):99-123. Feng Dai, Ember D. Keighley, Guangyun Sun, Subba Rao Indugula, Sarah T. Roberts, Karolina Åberg, Diane Smelser, John Tuitele, Li Jin, Ranjan Deka, Daniel E. Weeks, Stephen T. McGarvey. Genome-wide scan for adiposity-related phenotypes in adults from American Samoa. International Journal of Obesity. 2007 Dec 31 (12): 1832-42 Dai F, Sun G, Aberg K, Keighley ED, Indugula SR, Roberts ST, Smelser D, Viali S, Jin L, Deka R,Weeks DE, McGarvey ST.A Whole Genome Linkage Scan Identifies Multiple Chromosomal Regions Influencing Adiposity-Related Traits among Samoans.Annals of Human Genetics 2008. Nov 72: 780-792. Exhibit B Page 119 of 188 Curriculum Vitae Guangyun Sun, Ph.D. Page 4 of 7 K. Åberg, F. Dai, G. Sun, E. D. Keighley, S. R. Indugula, S. T. Roberts, Q. Zhang, D. Smelser, S. Viali, J. Tuitele, L. Jin, R. Deka, D. E. Weeks, S. T. McGarvey. Susceptibility loci for adiposity phenotypes on 8p, 9p and 16q in American Samoa and Samoa. Obesity(submitted in 2008) BM. Chakraborty1, Hee S. Lee, M Wolujewicz, J Mallik, Guangyun Sun, Kim N. Dietrich, Amit Bhattacharya, Ranjan Deka and Ranajit Chakraborty. Low Dose Effect of Chronic Lead Exposure on Neuromotor Response Impairment in Children is moderated by Genetic Polymorphisms. J. Hum. Ecol., 23(3): 183-194 (2008). Jessica G Woo, Guangyun Sun, Mary Haverbusch1, Subbarao Indugula, Lisa J Martin, Joseph P Broderick, Ranjan Deka and Daniel Woo. Quality assessment of buccal versus blood genomic DNA using the Affymetrix 500 K geneChip. BMC Genetics 2007, 8:79 Prodipto Pal, Huifeng Xi · Ritesh Kaushal, Guangyun Sun · Carol H. Jin · Li Jin, Brian K. Suarez · William J. Catalona, R Deka. Variants in the HEPSIN gene are associated with prostate cancer in men of European origin. Hum Genet (2006) 120:187–192. Guangyun Sun, Ritesh Kaushal, Prodipto Pal, Michael Wolujewicz, Diane Smelser, Hong Cheng, Mei Lu, Ranajit Chakraborty, Li Jin, and Ranjan Deka. Whole-Genome Amplification: Relative Efficiencies of the Current Methods. Legal Medicine 7: 279–286, 2005 BK Suarez1, P Pal, CH Jin, R Kaushal, G Sun, L Jin, B Pasche, R Deka and WJ Catalona. TGFBR1*6A is not associated with prostate cancer in men of European ancestry. Prostate Cancer and Prostatic Diseases,8: 50–53,2005 Guangyun Sun,Yixi Zhong,Stephen McGarvey,Riyad Bayoumi,Connie Kolman,Ramiro Barrantes,Salmo Raskin,Ranajit Chakraborty and Ranjan Deka.Global genetic variation at nine short tandem repeats loci and implication on forensic genetics. European Journal of Human Genetics,11(1):39-49,2003 Tsai H-J, Guangyun Sun, Smelser D, Viali S, Tufa J, Jin L, Weeks DE, McGarvey ST,Deka R. 2004. Distribution of genome-wide linkage disequilibrium based on microsatellite loci in the Samoan population. Hum Genomics 1:327-334,2004 Ranjan Dutta, B. Mohan Reddy, Chattopadhyay, V.K. Kashyap, Guangyun Sun, and Ranjan Deka. Patterns of Genetic Diversity at the Nine Forensically Approved STR Loci in the Indian Populations, Human Biology, 74(1): 33–49,200 B. Mohan Reddy, Guangyun Sun, Javier Rodriguez Luis, Michael H Crawford, Natabar Shyam Heman, and Ranjan Deka. Genomic Diversity at Thirteen Short Tandem Repeat Loci in a Substructured Caste Population, Golla, of Southern Andhra Pradesh, India, Human Biology, 73(2), 175–190, 2001 Stephen T McGarvey, Forest W, Weeks D E, Guangyun Sun, Diane Smelser, Tufa J, Viali S, Ranjan Deka. Human leptin locus (LEP) alleles and BMI in Samoans. International Journal of Obesity, 26 (6): 783-788,2002 Exhibit B Page 120 of 188 Curriculum Vitae Guangyun Sun, Ph.D. Page 5 of 7 G. Sun, S. Raskin, J. Sun, H. Cheng, A. Deka, R. Chakraborty and R. Deka. Double mutations can cause false exclusions in STR paternity testing, The American Journal of Human Genetics (supplement), 2002:1130 D. Smelser, G. Sun, H-J. Tsai, X. He, M. Wolujewicz, R. Indugula, J. Woo, J. Tufa, S. Viali, S. McGarvey, D.E Weeks, R. Deka. Polymorphisms in the HNF-1β, IGF1R, UCP1, GCK and ADRβ3 loci show significant association with type 2 diabetes in the Samoan population. Diabetes (supplement 2), 2002.51(2): A268 Meiyun Wu, Guangyun Sun, Daixin Huang, Lin Zhang, Yubo Chen. Allele frequency distributions for four VNTR loci in the Chinese Han. Journal of Forensic Sciences , 2001,46(2): 416 B.Mohan Reddy, Guangyun Sun, Dutta Ranjan, and R. Deka. STR data for the Amp-FlSTR Profiler-Plus loci among Golla population of Southern AndHRA Pradesh, India. . Journal of Forensic Sciences (USA), 2001,46(3): 734-735 Tsai H-J, Guangyun Sun, Weeks DE, McGarvey ST, Kaushal R, Wolujewicz M, Deka R. Type 2 diabetes and calpain-10 gene polymorphisms in Samoans. The American Journal of Human Genetics,69: 1236-1244,2001 Bing Su, Guangyun Sun, Daru Lu Junhua Xiao, Fang Fu, Ranajit Chakraborty, Ranjan Deka and Li Jin. Distribution of three HIV-1 resistance-conferring polymorphisms (SDF1-3'A, CCR2- 64I, and CCR5-32) in global populations. European Journal of Human Genetics, 8:975- 979,2000 Ranjan Deka, Guangyun Sun, Jonathan Wiest, Diane Smelser, Su Chunhua, Yixi Zhong and Ranajit Chakraborty. Patterns of Instability of Expanded CAG Repeats at the ERDA1 Locus in General Populations. The American Journal of Human Genetics, 65:192-198, 1999 Ranjan Deka, Guangyun Sun, Diane Smelser, Yixi Zhong, Marek Kimmel and Ranajit Chakraborty. Rate and Directionality of Mutations and Effects of Allele Size Constraints at Anonymous, Gene-Associated, and Disease-Causing Trinucleotide Loci. Molecular Biology and Evolution (USA), 16(9): 1166-1177,1999 Meiyun Wu, Langpin Zou, Bin Shen, Guangyun Sun, Ronghua Li and Guodi Chen. STR HUMARA Locus Gene and Genotype Frequencies in Han and Bei Populations in China. Journal of Forensic Sciences (USA), 1999,44(5): 1039 -1041 Guangyun Sun, Jing Qiang, Chen Lin and Wu Meiyun. The application of D1S80 locus analysis to forensic practice problems by using Amp-FLP technique. Journal of West China University of Medical Sciences, 1997.28(2): 154-159 Chen Guodi, Guangyun Sun, Li Yingbi and Wu Meiyun. A study of the adenosine deaminase (ADA) polymorphism in a Chinese Han population by the PCR method. Journal of West China University of Medical Sciences, 1998.29(1): 56-59 Wu Meiyun and Guangyun Sun. Analysis of the VNTR locus DXS52 by Amp-FLP technique. Journal of Forensic Sciences (USA), 1996.41(5): 859-861 Exhibit B Page 121 of 188 Curriculum Vitae Guangyun Sun, Ph.D. Page 6 of 7 Guangyun Sun and Wu Maeiyun. Polymorphic analysis of D4S95 and DXS52 loci in a Chinese Han population by the Amp- FLP technique. Chinese Journal of Medical Genetics, 1996,13(5):284-288 Jing Qiang,Guangyun Sun and Wu Meiyun. Amplified fragment length polymorphism analysis of the ApoB 3’ locus in Chinese of Han population,Chengdu.Chinese Journal of Blood Transfusion, 1995,8(3): 174-177 Chen Lin, Guangyun Sun and Wu Meiyun.Polymorphic analysis of the D17S30 locus in a Chinese Han population by the polymerase chain reaction.Chinese Journal of Medical Sciences, 1995, 12(2): 85-88 Guangyun Sun, Xu YunXiou and Wu Meiyun. Effects of some physical and chemical factors on both human hair DNA and results of sex determination by PCR. Journal of West China University of Medical Sciences, 1995,26(3): 311-314 Chen Lin, Guangyun Sun and Wu Meiyun. . Influence exerted by environmental and physicochemical factors on the results of sex identification of human dental pulp by polymerase chain reaction. Journal of West China University of Medical Sciences, 1994,25(3): 253-258 Guangyun Sun, Chen Lin and Wu Meiyun. Fast detection of Alu DNA in human tissues by Alu- PCR. Journal of West China University of Medical Sciences, 1994,25(4): 398-401 Guangyun Sun, Chen Lin and Wu Meiyun. Polymorphic analysis of the D1S80 locus in a Chinese Han population by the PCR method. Chinese Journal of Medical Genetics, 1994,11(3): 148-152 Chen Lin, Guangyun Sun and Wu Meiyun. Direct PCR amplification from whole blood, without DNA extraction. Chinese Journal of Medical Genetics, 1992,9(6): 352-353 Wu Meiyun and Guangyun Sun. Human bloodstain identification using DNA amplification technique. Journal of West China University of Medical Sciences, 1992,23(3): 248-250 Xu Yunxiou, Guangyun Sun and Wu Meiyun. Sex identification of human dental pulp by DNA amplification technique in vitro. Journal of Forensic Medicine (Shanghai,China),1992,8(2):54-55 Wu Meiyun and Guangyun Sun. The application of DNA amplification technique in vitro in forensic medicine practice. Chinese Journal of Forensic Medicine (Beijing, China), 1991,6 (2): 68-69 Guangyun Sun and Wu Meiyun. Human sex identification of dried bloodstains by PCR technique. Journal of West China University of Medical Sciences, 1990, 21 (3): 271-273 Wu Meiyun and Guangyun Sun. Human hair sex identification by analysis of amplified DNA sequences. Journal of Forensic Medicine (Shanghai, China), 1991, 7:1-3 Guangyun Sun, Cheng Wengyuan, Wang Zishu and Wang Xizhong. Restriction endonuclease banding of buffalo metaphase chromosome, Hereditas (Beijing, China), 1990,12(3):17-19 Exhibit B Page 122 of 188 Curriculum Vitae Guangyun Sun, Ph.D. Page 7 of 7 Guangyun Sun, Cheng Wengyuan, Wang Zishu and Wang Xizhong. A study on the G-banding of Dechang buffalo chromosome. Hereditas (Beijing, China), 1991, 13(4): 13-16 Guangyun Sun, W. Cheng, Wang Zishu and Yu Guixin. Studies on the nucleolar organizers (NORs) in buffalo chromosomes, Journal of Southwest Nationalities College, China.1990, 16 (3): 18-22 Books 1. Contributed: “Blood Group Serology and Examination of Physical Evidence”. Yunnan National Publication House, China, 1990 2. Contributed: “Forensic Biology”, Sichuan University Publication House, 2006 Note: Sichuan University and West China University of Medical Sciences merged as Sichuan University in 2001 Exhibit B Page 123 of 188 Curriculum Vitae Jessica Dade, Ph.D. Page 1 of 1 CURRICULUM VITAE JESSICA DADE, PH.D. EDUCATION Ph.D. – Molecular Genetics 2016 University of Cincinnati Cincinnati, Ohio B.S. – Biology 2009 Oakwood University Huntsville, AL PROFESSIONAL EXPERIENCE Assistant Laboratory Director 2016 - Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Graduate Research Assistant 2010 - 2016 Department of Molecular Genetics, Microbiology and Biochemistry University of Cincinnati Cincinnati, Ohio PUBLICATIONS Dade J, DuBois JC, Pasula R, Donnell AM, Caruso JA, Smulian AG, & Deepe GS HcZrt2, a zinc responsive gene, is indispensable for the survival of Histoplasma capsulatum in vivo” Medical Mycology (2016) (Manuscript accepted and in press) DuBois, J., Pasula, R., Dade, J., Smulian, A. Yeast Transcriptome and In Vivo Hypoxia Detection Reveals Histoplasma capsulatum Response to Low Oxygen Tension. Medical Mycology 2015 October PMID: 26483436 Stehling-Sun, S., Dade J., Nutt S., DeKoter, R. P., and Camargo F.D. Regulation of lymphoid versus myeloid fate ‘choice’ by the transcription factor Mef2c. 2009. [Online Publication] Nature Immunology. 25 January PMID: 19169261 Dade J. Bioinformatics Key to Cancer Discoveries. 2013. [Online Publication] healthnews.uc.edu. 30 May. Source: http://healthnews.uc.edu/news/?/22673/. Exhibit B Page 124 of 188 Curriculum Vitae Priya Kumar, Ph.D. Page 1 of 2 CURRICULUM VITAE PRIYA KUMAR, PH.D. EDUCATION Ph.D. – Biology 2014 Miami University Oxford, OH B.A. – Education 2005 Indraprastha University New Delhi, India M.S. – Zoology 2003 University of Delhi New Delhi, India B.S. – Zoology 2001 University of Delhi New Delhi, India PROFESSIONAL EXPERIENCE Assistant Laboratory Director 2017 - Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Postdoctoral Research Fellow 2015 – 2017 Division of Endocrinology, Cincinnati Children's Hospital Medical Center Cincinnati, OH Adjunct Assistant Professor 2016 University of Cincinnati Blue Ash, OH Graduate Research Assistant, Biology 2006 - 2008 Miami University Oxford, OH Exhibit B Page 125 of 188 Curriculum Vitae Priya Kumar, Ph.D. Page 2 of 2 AWARDS, FELLOWSHIPS, GRANTS • Awarded the Joint -Council of Scientific and Industrial Research -University Grants Commission Junior Research Fellowship (CSIR-UGC-JRF) -India Jan 2004. This is a national level exam for teaching positions at Universities and for PhD programs in India. • Received the academic challenge research grant (ACRG) funded by the Dept. of Biology, Miami University, January 2014. • Selected in the top 10 participants in the 3-minute Thesis Competition (3MT) held by the Graduate School, Miami University Oxford, OH, March 2014. PROFESSIONAL AFFILIATIONS Society for Neuroscience (SFN), 2006- 2009. American Society for Cell biology (ASCB) 2008- 2014. National Postdoctoral Association (NPA), 2015-2017. Endocrine Society, 2016. PUBLICATIONS Kumar P.L. and James P.F. 2015. Identification and characterization of methylation- dependent DNA regulatory elements in the human SLC9B1 gene. Gene. 561(2): 235-248. Kumar D.L., Kumar P.L. and James P.F. 2016. Methylation-dependent and independent regulation of Na,K-ATPase alpha 4 gene (Atp1a4) expression. Gene. 575(2): 339-352. Kumar D.L., Kumar P.L., Walczak R., Wagner B.D., Hummler E and James P.F. ENaC alpha is dispensable for sperm motility and fertility. Journal of Physiological Sciences. (Submitted) (Equal contribution paper). Salcedo C., Kumar P. L., Hwa V and Dauber A. IMAGe and related undergrowth syndromes: The complex spectrum of gain-of-function CDKN1C mutations. Pediatric Endocrinology Reviews. March 2017, 14:3. Exhibit B Page 126 of 188 Curriculum Vitae Maria Alejandra Gutierrez, Ph.D. Page 1 of 2 CURRICULUM VITAE MARIA ALEJANDRA GUTIERREZ, PH.D. EDUCATION Ph.D. – Systematic, Cytogenic, Phytochemical, and Pharmacological Studies 2011 National University of Cordoba Argentina B.S. – Pharmacy 2003 National University of Cordoba Argentina B.S. – Biochemistry, Microbiology 2001 National University of Cordoba Argentina PROFESSIONAL EXPERIENCE Assistant Laboratory Director 2017 – Present DNA Diagnostics Center, (DDC) Fairfield, OH Laboratory Supervisor 2015 – 2016 Sorenson Genomics – Identigene Inc. Salt Lake City, UT Principal Scientist 2012 - 2014 Cytozyme Inc. Salt Lake City, UT Laboratory Scientist/Quality Control 2011 – 2012 Cytozyme Inc. Salt Lake City, UT Research Scientist 2008 - 2009 University of Utah, Department of Biology Salt Lake City, UT Exhibit B Page 127 of 188 Curriculum Vitae Maria Alejandra Gutierrez, Ph.D. Page 2 of 2 PUBLICATIONS Gutiérrez, Alejandra, Gloria E. Barboza & L. Mentz. 2006.       (Solanaceae): Nueva cita para Argentina y Paraguay y su sinonimia. Darwiniana 44(2): 508-- 513. Gutiérrez, Alejandra. 2006. Malphigiaceae, en Barboza, G. E., J. J. Cantero, C. O. Nuñez & L. Ariza Espinar (eds.), Flora medicinal de la Provincia de Córdoba. Pteridófitas y Antófitas silvestres o naturalizadas: 852-- 856. Museo Botánico de Córdoba, Argentina. Gutiérrez, Alejandra & Gloria E. Barboza. 2006. Martyniaceae, en Barboza, G. E., J. J. Cantero, C. O. Nuñez & L. Ariza Espinar (eds.), Flora medicinal de la Provincia de Córdoba. Pteridófitas y Antófitas silvestres o naturalizadas: 887-- 889. Museo Botánico de Córdoba, Argentina. Gutiérrez, Alejandra. 2006. Portulacaceae, en Barboza, G. E., J. J. Cantero, C. O. Nuñez & L. Ariza Espinar (eds.), Flora medicinal de la Provincia de Córdoba. Pteridófitas y Antófitas silvestres o naturalizadas: 970-- 978. Museo Botánico de Córdoba, Argentina. Gutiérrez, Alejandra & Gloria E. Barboza. 2006. Valerianaceae, en Barboza, G. E., J. J. Cantero, C. O. Nuñez & L. Ariza Espinar (eds.), Flora medicinal de la Provincia de Córdoba. Pteridófitas y Antófitas silvestres o naturalizadas: 1120- - 1124. Museo Botánico de Córdoba, Argentina.   Gutiérrez, Alejandra & Gloria E. Barboza. 2006. Viscaceae, en Barboza, G. E., J. J. Cantero, C. O. Nuñez & L. Ariza Espinar (eds.), Flora medicinal de la Provincia de Córdoba. Pteridófitas y Antófitas silvestres o naturalizadas: 1160-- 1164. Museo Botánico de Córdoba, Argentina. Gutiérrez, Alejandra. 2006. Zygophyllaceae, en Barboza, G. E., J. J. Cantero, C. O. Nuñez & L. Ariza Espinar (eds.), Flora medicinal de la Provincia de Córdoba. Pteridófitas y Antófitas silvestres o naturalizadas: 1164-- 1175. Museo Botánico de Córdoba, Argentina. Exhibit B Page 128 of 188 Curriculum Vitae Jessica Wagoner, Ph.D. Page 1 of 1 CURRICULUM VITAE JESSICA WAGONER, PH.D. EDUCATION Ph.D. Genetics, Genomics and Development 2016 Department of Molecular Biology and Genetics Cornell University, Ithaca, NY Bachelor of Science (with Honors) 2008 Department of Molecular Genetics The Ohio State University, Columbus, OH PROFESSIONAL EXPERIENCE Assistant Laboratory Director 2017 – Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH 45014 Graduate Research Assistant 2008 - 2015 Department of Molecular Biology and Genetics Cornell University, Ithaca NY Undergraduate Research Assistant 2007 - 2008 Department of Molecular Genetics The Ohio State University, Columbus, OH PUBLICATIONS Wagoner, J.A., Sun, T., Lin, L., and Hanson, M.R. (2015). Cytidine deaminase motifs within the DYW domain of two pentatricopeptide repeat-containing proteins are required for site-specific chloroplast RNA editing. J. Biol. Chem. jbc.M114.622084. Exhibit B Page 129 of 188 Curriculum Vitae Julie A. Heinig, Ph.D. Page 1 of 9 CURRICULUM VITAE JULIE A. HEINIG, Ph.D. EDUCATION On-Line Coursework 2003 University of Florida Structure and Function of Nucleotides Scientific Evidence and Statistics Ph.D. – Anatomy and Cell Biology 2001 University of Toronto Toronto, Ontario M.S. – Zoology 1993 University of Toronto Toronto, Ontario B.S. – Honours Biology 1988 University of Toronto Scarborough, Ontario PROFESSIONAL EXPERIENCE Assistant Laboratory Director, Forensics 2003 – Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Senior Forensic Scientist/DNA Analyst 1998 – 2002 Cuyahoga County Coroner’s Office Cleveland, OH Instructor, Department of Life Sciences 1996 University of Toronto Scarborough, Ontario Teaching Assistant 1989 - 1994 University of Toronto Scarborough, Ontario Research Technician II 1991 Bedford Institute Dartmouth, Nova Scotia Exhibit B Page 130 of 188 Curriculum Vitae Julie A. Heinig, Ph.D. Page 2 of 9 PROFESSIONAL ASSOCIATIONS American Academy of Forensic Sciences (2000 – Present) Association of Forensic Quality Assurance Managers (2003 – 2007) Midwestern Association of Forensic Scientists (1999 – 2007) AWARDS Open Scholarship 1998 University of Toronto Seminar Series Award for Best Speaker 1994 University of Toronto Open Scholarship 1992 University of Toronto Scarborough College Graduate Student Award 1991 University of Toronto SPECIALIZED TRAINING/CONFERENCES ATTENDED Innocence Network Conference Atlanta, GA April 16-18, 2010 Promega 20th International Symposium on HID Fairfield, OH October 30, 2009 Ancestry DNA/DNA Witness (Mike Shiver, Ph.D.) Fairfield, OH October 7, 2009 Ohio Innocence Project Cincinnati, OH August 17, 2009 Innocence Network Conference Houston, TX March 20-22, 2009 Mitochondrial DNA Testing at AFDIL (Mike Coble, Ph.D.) Armed Forces DNA Identification Laboratory Fairfield, OH March 10, 2009 Exhibit B Page 131 of 188 Curriculum Vitae Julie A. Heinig, Ph.D. Page 3 of 9 STR Analysis in Forensic Casework and Paternity Testing Workshop on Y-STR Mixtures (Cassie Johnson, M.S.) Fairfield, OH March 5, 2009 AAFS 61st Annual Meeting Denver, CO February 18-20, 2009 Promega 19th International Symposium on HID Hollywood, CA October 13-16, 2008 Hamilton County Coroner, Educate the Living, Dr. Odell Owens, M.D. Fairfield, OH March 12, 2008 Review of International Society for Forensic Genetics Meeting, Copenhagen Fairfield, OH (Thomas Reid, Ph.D.) September 6, 2007 Applications of Directional Cell Migration (P. Lepont, Ph.D.) Fairfield, OH June 29, 2007 Gene Polymorphisms of Natural Killer Cell Receptors (J. Sun, Ph.D.) Fairfield, OH June 1, 2007 The Role of DNA in Forensics and Mass Tragedies (Dr. Conneally, Ph.D.) Fairfield, OH May 18, 2007 Internalization and Metabolic Activation of E. Coli O157:H7 (L. Farris) Fairfield, OH May 11, 2007 Forensic e-Symposium, Human Identification Profiling of Degraded and Low Amounts of DNA On-Line, March 27, 2007 DDC Workshop American Society of Human Genetics, AABB, Promega, MAFS Fairfield, OH November 10, 2006 Validation and Application of a Duplex qPCR Assay (Dr. L. Maddox) Fairfield, OH October 16, 2006 Exhibit B Page 132 of 188 Curriculum Vitae Julie A. Heinig, Ph.D. Page 4 of 9 MAFS 36th Annual Meeting Indianapolis, IN October 9-13, 2006 ABI Real Time 7500 Training – Chemistry and Software (Catherine Caberello) Fairfield, OH August 17, 2006 DNA View and Kinship (Dr. Charles Brenner) Fairfield, OH August 14, 2006 ABI Real Time 7500 – Installation and Training (Greg LaCrosse) Fairfield, OH August 8, 2006 Testing Fundamentals and Preparation for Trials (Dr. R. Cotton) Fairfield, OH May 17, 2006 ABI Trends Meeting Cincinnati, OH April 5, 2006 Promega 16th International Symposium on HID Dallas, TX September 25-29, 2005 National Association of Criminal Defense Lawyers Conference New Orleans, LA February 10, 2005 ABI 310 Training and GeneMapper v 3.2 (Catherine Caberello) Fairfield, OH January 18, 2005 Paternity Testing (Dr. Chakraborty) Fairfield, OH April 2, 2004 SNPs (Applied Biosystems) Fairfield, OH February 27, 2004 Profitable Exhibiting & Better Booth Staffing (Skyline Exhibits) Springdale, OH February 5, 2004 Exhibit B Page 133 of 188 Curriculum Vitae Julie A. Heinig, Ph.D. Page 5 of 9 National CODIS Conference Lansdowne, VA November 3-6, 2003 Association of Forensic Quality Assurance Mangers (AFQAM) Conference Indianapolis, IN October 6-9, 2003 Trends in Forensic DNA Technology Cincinnati, OH August 26, 2003 NFSTC Accreditation for Forensic Testing Compliance with ISO/IEC 17025 & DAB Standards Fairfield, OH June 9-10, 2003 Real Time PCR Seminar (Catherine Caberello) Fairfield, OH April 3, 2003 AAFS 55th Annual Meeting Chicago, IL February 19-21, 2003 3100 Training (Carol Schurzinger, ABI) Fairfield, OH January 14-15, 2003 Performance Level Auditing for the Crime Laboratory Workshop Richfield, OH April 17-18, 2002 CODIS Meeting (Ohio BCI & I) Richfield, OH March 11, 2002 CODIS Workshop (Cindy Shannon) Cuyahoga County Coroner’s Office Cleveland, OH April 4, 2001 Bloodstain Pattern Analysis Workshop Cuyahoga County Coroner’s Office (Toby Wolson) Cleveland, OH November 13-17, 2000 Exhibit B Page 134 of 188 Curriculum Vitae Julie A. Heinig, Ph.D. Page 6 of 9 Microscopy Training Workshop Cuyahoga County Coroner’s Office Cleveland, OH September 14-15, 2000 STR Workshop – FBI Cuyahoga County Coroner’s Office (Jill Smerick, Debbie Hobson) Cleveland, OH June 19, 2000 Mitochondrial DNA Analysis Course FBI Academy Quantico, VA June 5-16, 2000 Mock Trial Training – Expert Testimony in DNA Cuyahoga County Coroner’s Office Cleveland, OH April 5, 2000 Short Tandem Repeat Workshop Cuyahoga County Coroner’s Office (Catherine Caberello) Cleveland, OH February 6-10, 2000 Mock Trial Training – Expert Testimony in DNA Cuyahoga County Coroner’s Office Cleveland, OH July 10, 1999 Short Tandem Repeat Workshop – MAFS Chicago, IL March 9-12, 1999 Population Statistics in DNA Analysis Cuyahoga County Coroner’s Office (George Carmody, Jennifer Smith) Cleveland, OH December 8-9, 1998 Mock Trial Training – Expert Testimony in Serology and DNA Cuyahoga County Coroner’s Office Cleveland, OH November 22, 1998 Forensic Polymerase Chain Reaction Typing Method D1S80 Indianapolis, IN October 17-20, 1998 Exhibit B Page 135 of 188 Curriculum Vitae Julie A. Heinig, Ph.D. Page 7 of 9 EXPERT WITNESS TESTIMONY 2010-Fairfield, OH, Y-STR (defense; deposition) 2010-Covington, KY, STR (defense) 2010-Chagrin Falls, OH, STR (defense) 2010-Toledo, OH, STR (prosecution) 2010-Lafayette, LA, STR/Y-STR (defense) 2010-Fairfield, OH, STR (defense, phone testimony) 2010-Akron, OH, STR (defense) 2009-Fort Myers, FL, Y-STR (prosecution) 2009-Cuyahoga County, Cleveland, OH, Y-STR (prosecution) 2009-Wilmington, OH, STR (defense) 2009-Lake City, FL, Y-STR (defense) 2009-Cincinnati, OH, STR/Y-STR (defense) 2009-Lake City, FL, Y-STR (defense) 2009-Cincinnati, OH, STR (prosecution) 2009-Fort Myers, FL, Y-STR (prosecution, deposition) 2009-Fairfield, OH, STR (defense) 2009-New York, NY, STR/Y-STR (defense) 2009-St. Petersburg, FL, Y-STR (prosecution) 2009-Cuyahoga County, Cleveland, OH, Y-STR (prosecution) 2008-Fort Myers, FL, Y-STR (prosecution) 2008-Iron Mountain, MI (defense) 2008-Washington, DC, STR (defense) 2008-Fairfield, OH, Y-STR (deposition, criminal) 2008-Davenport, IA (defense) 2008-Cuyahoga County, Cleveland, OH, Y-STR (prosecution) 2008-Toledo, OH, Y-STR (defense) 2007-Cuyahoga County, Cleveland, OH, Y-STR (prosecution) 2007-Prestonburg, KY (defense) 2007-Whitman County, WA (jury trial; testify by phone; defense) 2007-Pontiac, IL, Y-STR (prosecution) 2007-Cuyahoga County, Cleveland, OH, Y-STR (prosecution) 2007-Washington, DC (defense) 2006-Cuyahoga County, Cleveland, OH, Y-STR (prosecution) 2006-Lima, OH (defense) 2006-Cincinnati, OH (deposition; civil matter) 2006-Hamilton County, Cincinnati, OH (juvenile court; defense) 2005-Lucas County, Toledo, OH (defense) 2005-Naval Station, Bremerton, WA, Y-STR (prosecution) 2005-Hamilton County, Cincinnati, OH (defense) Exhibit B Page 136 of 188 Curriculum Vitae Julie A. Heinig, Ph.D. Page 8 of 9 PUBLICATIONS Heinig, J.A. (2007) The Use and Significance of Y-STR Testing, The DDC Link: Forensic Newsletter, Fall 2007. Heinig, J.A. (2007) DNA from Fingerprints. Columbus Bar Association; Lawyer’s Quarterly, Fall 2007. Heinig, J.A. (2007) One DNA TestMany Interpretations.Reasonable Doubt? The DDC Link: Forensic Newsletter, July 2007. Heinig, J.A. (2007) DNA from Fingerprints. The DDC Link: Forensic Newsletter, April 2007 Youson, J.H., Heinig, J.A., Khanam, S.F., Sower, S.A., Kawauchi, H., and Keeley, F.W. (2006) Patterns of propiomelanocortin and proopiocortin gene expression and immunohistochemistry for gonadotropin-releasing hormones (1GnRH-I and III) during the life cycle of a nonparasitic lamprey: Relationship to this adult life history type. Gen Comp Endo, 148: 54-71. Heinig, J.A. (2005) DNA from Fingerprints. Northern Kentucky Bar Association, August/September 2005. Heinig, J.A., Keeley, F.W., Kawauchi, H., and Youson, J.H. Expression of proopiocortin and proopiomelanotropin during the life cycle of the sea lamprey (Petromyzon marinus). J. Exp. Zool. 283: 95-101. Filosa, M.F., Adam, I., Robson, P., Heinig, J.A., Smith, K., Keeley, F.W., and Youson, J.H. (1999) A partial clone of the gene for AS protein of the lamprey Petromyzon marinus: A member of the albumin supergene family whose expression is restricted to the larval and metamorphic phases of the life cycle. J. Exp. Zool. In Press. Ficele, G., Heinig, J.A., Kawauchi, H., Youson, J.H., Keeley, F.W., and Wright, G.M. (1998) Spatial and temporal distribution of proopiomelanotropin (POM) and proopiocortin (POC) mRNA during development of the sea lamprey: a qualitative and quantitative in situ hybridization study. Gen. Comp. Endocrinology, 110: 212-225. Heinig, J.A., Keeley, F.W., Robson, P., Sower, S.A., and Youson, J.H. (1995) The appearance of proopiomelanocortin early in vertebrate evolution: Cloning and sequencing of POMC from a lamprey pituitary cDNA library. Gen. Comp. Endocrinology, 99: 137-144. PRESENTATIONS Peterson, J.W., Baird, M.L., Reid, T.M., Karemer, C.M., Hodge, D.M., Schuh, C.M., Deickhoner, C.L., Ahmed, M.B., Heinig, J.A., Kahsar, M.D., Lee, S.C., and Lee, R.F. (2005) DDCPlex™: The Use of Additional STR Loci for Solving Difficult Parentage and Sibship Tests. Promega 16th International Symposium on HID. Dallas, TX. September 25-29, 2005. Exhibit B Page 137 of 188 Curriculum Vitae Julie A. Heinig, Ph.D. Page 9 of 9 Gamble, R.L., Suzuki, K., Heinig, J.A., Youson, J.H., Keeley, F.W., and Sower, S.A. (1997) Isolation of cDNA encoding the precursor to lamprey gonadotropin-releasing hormone-I from the brain of the sea lamprey, Petromyzon marinus. Proceedings of the XIIIth International Congress of Comparative Endocrinology, Nov. 16-21, 1997. Yokahama, Japan. Advances in Comparative Endocrinology, S. Kawashima and S. Kituyama, eds. Monduzzi Editore, Bologna, pp. 735-738. Heinig, J.A., Youson, J.H., and Keeley, F.W. (1996) Expression of two forms of POMC (proopiomelanocortin) during metamorphosis and sexual maturation of the lamprey. The FASEB Journal, Vol. 10 (No. 3). Presented at Experimental Biology ’96, Washington, D.C., April 16-20, 1996. Heinig, J.A., Keeley, F.W., and Youson, J.H. (1994) Sequence of a POMC cDNA clone from lamprey pituitary. American Zoologist, Vol. 34 (No. 5). Presented at American Society of Zoologists, St. Louis, MO, January 4-8, 1995. Heinig, J.A. and Youson, J.H. (1991) Freeze fracture and morphometric analyses of zonulae occludentes in the anterior intestinal epithelium of adult lampreys during osmoregulation. Developmental Biology, Vol. 45 (No. 2). Presented at American Association of Anatomists, New York, NY, March 11-15, 1992. Exhibit B Page 138 of 188 Curriculum Vitae Christopher M. Kraemer Page 1 of 2 CURRICULUM VITAE CHRISTOPHER M. KRAEMER EDUCATION B.S. – Biology 2001 University of Cincinnati Cincinnati, OH PROFESSIONAL EXPERIENCE Director, Laboratory Operations 2018 - Present DNA Diagnostics Center (DDC) Fairfield, OH Manager, Laboratory, Corporate Compliance and Safety 2016 - 2018 DNA Diagnostics Center (DDC) Fairfield, OH Senior Laboratory Manager 2012 - 2016 DNA Diagnostics Center (DDC) Fairfield, OH Technical Supervisor 2002 - 2012 DNA Diagnostics Center (DDC) Fairfield, OH Lead Technologist 2001 – 2002 DNA Diagnostics Center (DDC) Fairfield, OH Laboratory Technologist 1998 – 2001 DNA Diagnostics Center (DDC) Fairfield, OH Laboratory Technician 1997 – 1998 DNA Diagnostics Center (DDC) Fairfield, OH PUBLICATIONS Reid, T.M., Ingala, D.A., Kraemer, C.M., Dage, W.M., Dieckhoner, C., Fortman, J.F., Hodge, D.M., Johnson, K.L., Oatman, C., Schlotman, H., Schuh, C., and Baird, M.L. Distribution of Exhibit B Page 139 of 188 Curriculum Vitae Christopher M. Kraemer Page 2 of 2 HUMACTBP2 (SE33) alleles in three North American populations. J. Forensic Science, 48: 1422- 1423, 2003. Reid, T.M., Wolf, C.A., Kraemer, C.M., Lee, S.C., Baird, M.L., and Lee, R.F. Specificity of sibship determination using the ABI Identifiler multiplex system. J. Forensic Science, 49: 1262-1264, 2004. Peterson, J.W., Reid, T.M., Kraemer, C.M., Ingala, D.A., Baird, M.L., Lee, S.C., and Lee, R.F. Distribution of Penta B, Penta C, and Penta E alleles in Asian, Black, Caucasian, and Hispanic populations. J. Forensic Science, 50: 966-968, 2005. Exhibit B Page 140 of 188 Curriculum Vitae Todd Lewis, Ph.D. Page 1 of 2 CURRICULUM VITAE TODD LEWIS, PH.D EDUCATION Doctor of Philosophy: Biomedical Sciences 2017 Wright State University Dayton, OH Master of Business Administration 2015 Wright State University Dayton, OH Bachelor of Science: Biology 2010 Wright State University Dayton, OH PROFESSIONAL EXPERIENCE Quality Assurance Manager 2018 - Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Clinical Research Associate 2016 - 2018 Medpace Cincinnati, OH Graduate Research Assistant 2010 to 2016 Wright State University Dayton, OH Business Owner 2002 to 2010 Pinnacle Painting Company Kettering, OH PUBLICATIONS Liu G., Chen X., Gao Y., Lewis T., Barthelemy J., and Leffak M. (2012). Altered replication promotes instability of DMPK (CTG)n • (CAG)n repeats. Mol Cell Biol 32, 1618-32. Exhibit B Page 141 of 188 Curriculum Vitae Todd Lewis, Ph.D. Page 2 of 2 Virts E., Jankowska A., Mackay C., Glaas M., Wiek C., Kelich S.,Lottmann N., Kennedy F., Marchal C., Lehnert E., Scharf R., Dufour C., Lanciotti M., Farruggia P., Santoro A., Savasan S., Scheckenbach K., Schipper J., Wagenmann M., Lewis T., Leffak M., Hanenberg H., et al. (2015). AluY-mediated germline deletion, duplication and somatic stem cell reversion in UBE2T defines a new subtype of Fanconi anemia. Hum Mol Genet 24:5093-108. Gadgil R, Barthelemy J, Lewis T, Leffak M. (2016). Replication stalling and DNA microsatellite instability. Biophys Chem 10.1016/j.bpc.2016.11.007. Exhibit B Page 142 of 188 Curriculum Vitae Lori Neff Page 1 of 2 CURRICULUM VITAE LORI NEFF EDUCATION Associate of Applied Science, Medical Laboratory Technology 1991 Clark State Community College Beavercreek, OH PROFESSIONAL EXPERIENCE Director, Government Contracts 2015 - Present DNA Diagnostics Center Inc. (DDC) Fairfield, OH Director Customer Service 2012 - 2015 DNA Diagnostics Center Inc. (DDC) Fairfield, OH Director, North American Customer Service 2005 - 2012 Orchid Cellmark Inc. Dayton, OH Manager, Specimen Collection Network 2002 - 2005 Orchid Cellmark Inc. Dayton, OH Bone Marrow Services Supervisor 1997 - 2002 Orchid Cellmark Inc. Dayton, OH Paternity Team Leader 1994 - 1997 Orchid GeneScreen Dayton, OH Laboratory Technician 1992 - 1994 Orchid GeneScreen Dayton, OH Medical Laboratory Technician 1991 – 1992 Mercer County Joint Township Coldwater, OH Exhibit B Page 143 of 188 Curriculum Vitae Lori Neff Page 2 of 2 CERTIFICATIONS American Society of Clinical Pathology Board of Registry Medical Laboratory Technician MILITARY SERVICE Hospital Corpsman, HM3 1989 - 1997 United States Naval Reserve (Honorable Discharge) Exhibit B Page 144 of 188 Curriculum Vitae Shauna Ford Page 1 of 1 CURRICULUM VITAE SHAUNA FORD EDUCATION B.S. Psychology 2004 Wright State University Dayton, Ohio PROFESSIONAL EXPERIENCE Manager, Contracts Customer Service and Scheduling 2014- Present DNA Diagnostics Center, Inc. Fairfield, OH Team Leader, Customer Service 2013 - 2014 DNA Diagnostics Center, Inc. Fairfield, OH Specimen Collection Coordinator 2012 - 2013 DNA Diagnostics Center, Inc. Fairfield, OH Specimen Collection Coordinator 2009 - 2012 Orchid Cellmark Dayton, OH Customer Service Coordinator 2006 - 2009 Orchid Cellmark Dayton, OH Case Management Associate 2005 - 2006 Orchid Cellmark Dayton, OH Exhibit B Page 145 of 188 Curriculum Vitae Sarah Ballard Page 1 of 1 CURRICULUM VITAE SARAH BALLARD EDUCATION West Carrollton High School 1992 West Carrollton, OH PROFESSIONAL EXPERIENCE Customer Service Account Specialist 2017 – Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Scheduling Associate 2012 – 2017 DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Scheduling Associate 2009 – 2012 Orchid Cellmark, Inc. Dayton, OH Medical Billing and Data Entry Clerk 2007 - 2009 Advanced Medical Equipment Kettering, OH Project Manager 1999 - 2006 Lason Baton Rouge, LA Loss Prevention 1995 - 1998 Meijer West Carrollton, OH Exhibit B Page 146 of 188 Curriculum Vitae Kellie Bunch Page 1 of 1 CURRICULUM VITAE KELLIE BUNCH EDUCATION High School Diploma 1992 Princeton High School Cincinnati, OH Scarlet Oaks Career Development Center 1992 Certification in Business/Executive Administrative Assistant Cincinnati, OH PROFESSIONAL EXPERIENCE Team Leader, Scheduling 2015 - Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Senior Team Member, Scheduling 2013 – 2015 DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Customer Service and Scheduling Representative 2009 – 2013 DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Case Management Specialist 2007 - 2009 DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Customer Service/Order Entry/Payroll Representative 1998 - 2006 Overhead Door Service Cincinnati, OH Inventory Control/ Accounts Payable/Receivable 1993 - 1998 Robert James Sales Cincinnati, OH Exhibit B Page 147 of 188 Curriculum Vitae Jon Strong Page 1 of 2 CURRICULUM VITAE JON STRONG EDUCATION MBA in Management and Finance 1983 Drexel University Philadelphia, PA Masters, Modern Psychoanalysis 1980 Philadelphia School of Psychoanalysis Philadelphia, PA BA, Psychology and Cognitive Processes 1978 University of Pennsylvania Philadelphia, PA PROFESSIONAL EXPERIENCE Chief Information Officer 2018 – Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Global Delivery Director 2010 – 2012 TEKSystems Global Services, LLC Hanover, MD Principal 2008 – Present The Strong Group Princeton, NJ Chief Technology Officer/Chief Information Officer 2006 – 2007 MRU Holdings, Inc. New York, NY President 1993 - 2006 The Strong Group Princeton, NJ Director, Management Consulting 1991 – 1993 DMR Group, Inc. Exhibit B Page 148 of 188 Curriculum Vitae Jon Strong Page 2 of 2 Projects Director, Northeast 1989 – 1991 CAP Gemini America New York, NY Senior Management Consultant 1986 – 1989 Touche Ross Newark, NJ Manager, Interactive Systems 1980 -1986 RCA Corporate Staff Cherry Hill, NJ Exhibit B Page 149 of 188 Curriculum Vitae Lauren Elkins Page 1 of 1 CURRICULUM VITAE LAUREN ELKINS EDUCATION B.S., Organizational Leadership 2013 Northern Kentucky University Newport, KY PROFESSIONAL EXPERIENCE Supervisor, Specimen Collection Network 2018 – Present DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Coordinator, Specimen Collection Network 2014 - 2018 DNA Diagnostics Center, Inc. (DDC) Fairfield, OH Laboratory Technician 2011 – 2014 CSL Plasma Hamilton, OH School Nurse’s Aid 2007 – 2008 Hamilton City Schools Hamilton, OH Exhibit B Page 150 of 188 DNA samples were isolated from unrelated individuals from three North American populations: Black, Caucasian, and His- panic, using a modified alkaline lysis method (1). The SE33 locus was amplified using the PowerPlex®ES Monoplex System, SE33 (Promega Corp., Madison, WI) according to the manufacturers rec- ommendations. Amplified DNA was analyzed with an ABI Prism 3100 Genetic Analyzer (Applied Biosystems, Foster City, CA). Population data were analyzed for Hardy-Weinberg equilibrium (2) and other population parameters with DNA-View software, version 25.05 (3). The complete data set is available upon request via e-mail from tmr@dnacenter.com. References 1. Rudbeck L, Jorgen D. Rapid, simple alkaline extraction of human ge- nomic DNA from whole blood, buccal epithelial cells, semen and foren- sic stains for PCR. Biotechniques 1998;25:588–92. 2. Gou SW, Thompson EA. Performing the exact tests of Hardy-Weinberg proportion for multiple alleles. Biometrics 1992;48:361–72. 3. http://dna-view.com Additional information and reprint requests: Thomas Reid DNA Diagnostics Center 205 Corporate Court Fairfield, OH 45014 E-mail: tmr@dnacenter.com Copyright © 2003 by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. FOR THE RECORD Thomas M. Reid,1 Ph.D.; David A. Ingala,1 B.S.; Christopher M. Kraemer,1 B.S.; Wendy M. Dage,1 B.S.; Christine Dieckhoner,1 B.A.; Joseph Fortman,1 B.S.; Diana M. Hodge,1 B.A.; Kristie L. Johnson,1 B.A.; Carla Oatman,1 B.S.; Holly Schlotman,1 B.S.; Christina Schuh,1 A.A.S.; and Michael L. Baird,1 Ph.D. Distribution of HUMACTBP2 (SE33) Alleles in Three North American Populations POPULATION:North American Black, Caucasian, and Hispanic KEYWORDS:forensic science, SE33, population genetics, human identification, short tandem repeats J Forensic Sci, Nov. 2003, Vol. 48, No. 6 Paper ID JFS2003172_486 Published xxx Available online at: www.astm.org 1 1 DNA Diagnostics Center, Fairfield, OH. Exhibit B Page 151 of 188 2 JOURNAL OF FORENSIC SCIENCES TABLE 1—SE33 allele frequencies in three North American populations. Black Caucasian Hispanic Allele Number Frequency Number Frequency Number Frequency 11 1 0.005 a11.2 1 0.005 1 0.005 12 1 0.005 13 2 0.01 2 0.01 13.2 1 0.005 14 12 0.06 11 0.055 3 0.015 15 8 0.04 10 0.05 6 0.03 16 12 0.06 10 0.05 8 0.04 16.2 1 0.005 17 18 0.09 7 0.035 28 0.14 18 24 0.12 13 0.065 31 0.155 19 29 0.145 20 0.1 16 0.08 20 18 0.09 10 0.05 12 0.06 20.2 1 0.005 2 0.01 1 0.005 21 10 0.05 6 0.03 9 0.045 21.2 2 0.01 2 0.01 22 3 0.015 1 0.005 22.2 1 0.005 7 0.035 5 0.025 23 1 0.005 23.2 4 0.02 7 0.035 5 0.025 24 1 0.005 24.2 3 0.015 13 0.065 6 0.03 25.2 6 0.03 5 0.025 2 0.01 26 2 0.01 26.2 5 0.025 13 0.065 14 0.07 27.2 10 0.05 10 0.05 12 0.06 28 1 0.005 28.2 13 0.065 19 0.095 9 0.045 29.2 9 0.045 12 0.06 16 0.08 30.2 4 0.02 9 0.045 5 0.025 31.2 8 0.04 2 0.01 32.2 1 0.005 2 0.01 33 1 0.005 1 0.005 1 0.005 33.2 1 0.005 34 1 0.005 n 200 200 200 TABLE 2—SE33 population parameters in three North American populations. Parameter Black Caucasian Hispanic H-W Equilibrium, exact test (p) 0.081 0.080 0.701 Observed Heterozygosity 0.940 0.930 0.940 Expected Heterozygosity 0.927 0.944 0.924 Power of Discrimination (PD) 0.990 0.994 0.989 Power of Exclusion (PE) 0.847 0.882 0.838 Typical Paternity Index (PI) 7.290 8.590 7.310 Exhibit B Page 152 of 188 Exhibit B Page 153 of 188 Exhibit B Page 154 of 188 Exhibit B Page 155 of 188 1DDC Direct ConnectExhibit BPage 156 of 188 2  !+ + '&$!& + %&%&, +4+,% 2 ! 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