Statement of Work - Specialized Genetic Laboratory Testing Services.doc

Statement of Work

1. Requirement.

a. Contractor will provide all personnel, labor, transportation, equipment, materials and supplies necessary to provide Specialized Genetic Laboratory Testing and guidance in Exome and Genomic tests, Oncology, and Pathology as specified herein for eligible Veterans Affairs (VA) beneficiaries of the South Texas Veterans Health Care System (STVHCS), Audie L. Murphy Division, located at 7400 Merton Minter Blvd., San Antonio, TX 78229-4404.

b. The Contractor must provide complementary studies that produce evidence to reduce variants of unknown significance (VUS). The laboratory must be able to provide evidence of supporting variant classifications in the final results report sent to clinicians. The evidence summary must include any significant published literature references as well as internal laboratory data weighted towards the reported classification for full transparency.

c. Contractor shall provide the following tests in-house. Test must be equivalent to the test description described below.

APC, ATM, AXIN2, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1

CDH1, CDKN2A, CHEK2, EPCAM, FH, FLCN, GREM1, HOXB13, MBD4, MET, MLH1, MSH2, MSH3, MSH6, MUTYH, NF1, NTHL1, PALB2, PMS2, POLD1, POLE, PTEN, RAD51C, RAD51D, RPS20, SMAD4, STK11, TP53, TSC1, TSC2, VHL 14-21 Days

APC, AXIN2, BMPR1A, CDH1, EPCAM, GREM1, MBD4, MLH1, MSH2, MSH3, MSH6, MUTYH, NTHL1, PMS2, POLD1, POLE, PTEN, RPS20, SMAD4, STK11, TP53

RNA Insight: AIP, ALK, APC, ATM, ATRIP, AXIN2, BAP1, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDC73, CDH1, DK4, DKN1B, CDKN2A, CEBPA, CFTR, CHEK2, CPA1, CTNNA1, CTRC, DX4, DICER1, EGFR, EGLN1, EPCAM, ETV6, FH, FLCN, GATA2, GREM1, HOXB13, KIF1B, KIT, LZTR1, MAX, MBD4, MEN1, MET, MITF, MLH1, MLH3, MSH2, MSH3, MSH6, MUTYH, NF1, NF2, NTHL1, PALB2, PALLD, PDGFRA, PHOX2B, PMS2, POLD1, POLE, POT1, PRKAR1A, PRSS1, PTCH1, PTEN, RAD51B, RAD51C, RAD51D, RB1, RET, RNF43, RPS20, RUNX1, SDHA, SDHAF2, SDHB, SDHC, SDHD, SMAD4, SMARCA4, MARCB1, MARCE1, SPINK1, STK11, UFU, TERT, TMEM127, TP53, TSC1, TSC2, VHL, WT1 14-21 Days

d. Test Ordering. The Contractor must have a secure online portal for genetic test ordering, tracking, and result reporting.

e. The Contractor shall provide timely (defined by the minimum and maximum turnaround times detailed in the description of requirements) and appropriate testing of patient specimens as requested by STVHCS facilities.

f. Each STVHCS facility will provide laboratory specimens properly collected identified with both the Patient’s Identification (as utilized by each facility) and requested tests. For those specimens that require special handling, the Contractor shall provide at no additional charge an adequate supply of specimen collection materials for such testing that is destined to the commercial reference laboratory for analysis. Supplies include collection tubes, buccal swab, pre-paid Fed-Ex shipping with an option for expedited shipment.

g. Each test report shall at minimum indicate the following information:

1) Patient's name and/or identification number

2) Physician's name (if supplied)

3) VISN 17 medical record number or laboratory accession number (if supplied)

4) VISN 17 submitting facility name

5) Patient's location (clinic/ward) (if supplied)

6) Test ordered

7) Date/time of specimen collection (when available)

8) Date/time test completed

9) Test result

10) Reference intervals

11) Toxic and therapeutic ranges, if applicable

12) Flagged abnormal test results

13) Reference laboratory specimen number

14) Name of testing laboratory, if other than Contractor

15) Any other information the laboratory has that may indicate a questionable validity of test results

h. Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing.

i. Contractor shall provide daily, by 12:00 PM, a report listing all incomplete specimens and their processing status.

j. Contractor shall provide monthly, a Utilization report that lists all tests and costs for the previous month by the 10th of each month.

k. The Contractor shall store the specimens a minimum of seven (7) to ten (10) days after the test is reported in the event that subsequent action is necessary (i.e. problem solving, add-on test, and/or repeat testing). The Contractor shall state their specimen retention time.

l. Specimens will be shipped as required to the Contractor for further processing.

m. Once laboratory requests with Patient Demographics for identification purposes are processed by the Contractor, the results will be returned to the VA Processing Section via secure fax or secure computer workstation for entering results in Dynamic Host Configuration Protocol (DHCP) by VA personnel. Information will then be made electronically available to the clinicians by VA personnel.

n. Laboratory procedures that have not been assigned a log number will not be paid by the STVHCS or performed by the Contractor.

2. Certifications. The Reference Laboratory selected is required to be fully licensed, accredited and inspected by the Laboratory Accreditation of an accrediting agency to include College of American Pathologists (CAP) with deemed status from the Center for Medicare and Medicaid Services, Center for Disease Control and any other state regulatory agencies as mandated by Federal and State Statutes. The Laboratory is required to be certified by the Joint Commission, American Associates of Blood Banks (AABB) as applicable. The Clinical Laboratory shall meet all requirements set forth by the Clinical Laboratory Improvement Act (CLIA) of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information (HIPPA). In addition, contractors must meet all requirements outlined in VHA Directive 1106. These above-mentioned requirements must be met upon the date of Solicitation.

3. Holidays and Work Hours. Contractor shall be responsible for providing services between the hours of 8:00am and 4:30pm Monday through Friday excluding Federal Holidays. Federal Holidays are as follows:

New Year’s Day

January 1st

Birthday of Martin Luther King Jr.

3rd Monday in January

Washington’s Birthday

3rd Monday in February

Memorial Day

Last Monday in May

Juneteenth National Independence Day

June 19th

Independence Day

July 4th

Labor Day

1st Monday in September

Columbus Day

2nd Monday in October

Veterans Day

November 11th

Thanksgiving Day

4th Thursday in November

Christmas Day

December 25th In addition to the days designated as holidays, the Government observes the following days: Any other day designated by Federal Statute. Any other day designated by Executive Order. Any other day designated by the President’s Proclamation.

4. Contracting Officer. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such changes at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

5. Government Inherent Functions. Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

6. Information Systems Officer, Information Protection. The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

7. Privacy Officer. The contractor will have access to Patient Health Information (PHI) but will not have the capability of accessing patient information from the VA System during the services provided to the VA.

8. Records Management. The contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

a. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

b. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

c. STVHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of STVHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

d. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to STVHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

e. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to STVHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

f. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and STVHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with STVHCS policy.

h. The Contractor shall not create or maintain any records containing any non-public STVHCS information that are not specifically tied to or authorized by the contract.

i. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

j. STVHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which STVHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

k. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

9. Health Insurance Portability and Accountability Act (HIPAA) Compliance (Feb 2010). HIPAA compliance is required. The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA).

10. National Provider Identifier (NPI) Information Required (Feb 2010). All Contractors and healthcare practitioners who provide billable healthcare services to the Department of Veterans Affairs, VHA, shall obtain a National Provider Identifier (NPI) as required by the Health Insurance Portability and Accountability Act (HIPPA) National Provider Identifier Final Rule, administered by the Centers for Medicare and Medicaid Services (CMS). This rule establishes assignment of a 10-digit numeric identifier for healthcare practitioners, intended to replace the many identifiers currently assigned by various health plans. Each practitioner needs only one NPI, valid for all employers and health plans. The NPI may be obtained via a secure website at: https://nppes.cms.hhs.gov/NPPES. Contractors must also designate their Specialties/Subspecialties by means of Taxonomy Codes on the NPI application.

(End of Statement of Work)