HLA testing PWS.docx

Performance Work Statement for Reference Lab/ Transplant Immunology Testing Services

1. Background The Contractor shall provide specific transplant immunology testing in support of the transplant service performed by the Department of Veteran’s Affairs Tennessee Valley Healthcare System, Nashville TN (hereafter referred to as TVHS). These tests identify a patient’s Human Leukocyte Antigen (HLA) type and Antibody status so that when organs are available for transplantation, physicians can find compatible donors. The Contractor must specialize in the aforementioned HLA testing, be American Society of Histocompatibility and Immunogenetics (ASHI) accredited and offer turnaround time in accordance with section 15.2.2

2. Requirements

2.1 The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing to identify histocompatibility. Estimated quantities of tests will depend upon patient specifics. See table listing specific tests. Pathology & Laboratory Medicine Service (P&LMS) requires support services in the form of special reference testing analysis that are not currently performed in-house to ensure successful organ transplants for TVHS patients.

2.2 Testing is highly esoteric and the lab must provide the full test menu required as a small sample cannot be split between labs. Given the time-sensitive nature for some of this testing (e.g. need for rapid results on donor organs), a local and rapid laboratory is required that offers turnaround time in accordance with section 15.2.2. STAT and routine testing cannot be separated as the lab needs to be able to refer to previous test results from routine testing on the same recipient patient when performing STAT testing on the donor. The testing platforms are complex and results sufficiently detailed that coordinating results between two separate reference labs is a patient safety issue. Therefore, STAT and routine testing must be performed by the same local HLA lab and offer turnaround time in accordance with section 15.2.2. The reference laboratory must provide or be contracted with a service that provides at-home testing kits with pre-paid mailers for panel reactive antibodies.

2.3 The vendor shall be located within a 50-mile radius of the TVHS campus and shall have the ability to perform all testing services on site. Vendor must ensure turnaround time in accordance with section 15.2.2 and must be available to complete testing 24 hours a day, 7 days a week, 52 weeks a year. The vendor must provide contact information so that TVHS is able to ask about specimen status, specimen submission questions, and other inquiries with testing personnel. The medical director must be available during routine business hours to address more complex questions.

3. Payment

4. Accounting/Invoices

5. Specimen Testing

5.1 The Contractor shall provide the full range of Histocompatibility testing. Contractor shall make available the following test information:

1. Requisition form requirements

1. Alphabetized test name list

1. Test order code

1. Specimen collection and preservation requirements

1. Test method employed (indicate if testing performed in duplicate) and interpretations

1. Test reference intervals adjusted for age, sex or race, when required

1. Test specific sensitivity, specificity and interferences, when required

1. Result code

1. Test critical values, if any

1. Policy for critical value notification

1. CPT coding

1. Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of specimen by the Contractor and receipt of results by the requesting Government facility.

1. Schedule of test performance (specific days of week indicated)

1. Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited)

5.2 Contractor shall notify the COR of any test information modifications no later than two weeks prior to the implementation date of the test change. Any new test(s) not listed in Attachment A must be added to the contract through modification by the Contracting Officer (CORs and Government facility representatives do not have this authority) prior to specimen being tested.

5.3 All reference laboratory testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation by the laboratory. Upon request, the assay’s validation plan and validation results shall be made available to the COR or designee.

5.4 The Contractor shall ensure the accurate and timely performance of laboratory testing services on the biomedical materials.

6. HIPAA Compliance

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). The VA has recognized Diagnostic Laboratory Facilities as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no Business Associate Agreement (BAA) is required for Reference Laboratory Services.

7. Designation of Contracting Officer Representatives Pathology and Laboratory Administrative Officer – TVHS Pathology & Laboratory Medicine Services (P&LMS), shall designate a COR to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The extent and limitations of the COR designation will be provided in the COR Delegation Memo.

8. Performance Monitoring

9. Conflicts of Interest The Contractor is responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and be fully outlined in response to the subject attachment in Section D of the solicitation document.

10. Citizenship Related Requirements

10.1 The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, as amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement, and the U.S. Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to the Department of Veterans Affairs.

10.2 While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

10.3 If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

10.4 This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

10.5 The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

11. Inherent Government Functions

Contractor and Contractor’s testing personnel 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 (outside a clinical context), 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.

12. No Employee Status The Contractor shall be responsible for protecting the Contractor’s testing personnel that are furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their employees providing services under the resultant contract:

· Workers’ compensation

· Professional liability insurance

· Safety training on bloodborne pathogens to employees who will be handling potentially infectious materials

· Health examinations to include:

· Maintaining records of evidence of Hepatitis B immunization status for each employee or documentation of attempts to obtain such records

· Availability of hepatitis B vaccination to testing personnel free of charge, as per OSHA bloodborne pathogens standards

· Income tax withholding, and

· Social security payments

13. Tort Liability The Federal Tort Claims Act does not cover Contractor or contract personnel. When a Contractor has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s action or non-action shall be the responsibility of the Contractor and/or his insurance carrier.

14. Conflict of Interest

The Contractor is responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in Section D of the solicitation document.

15. PERFORMANCE STANDARDS/ QUALITY ASSURANCE (QA) SURVEILLANCE PLAN

15.1. Quality Management/ Quality Assurance Surveillance

Contractor’s testing services shall be subject to Quality Management measures, such as timely completion of testing, successful maintenance of accreditation, accuracy of testing results, and completeness of reports. Methods of Surveillance: Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted. Documentation of all testing performed shall also be maintained by the Contractor. The contract COR will certify the case type and charge for rendered services. All adverse actions shall be reported to the Contracting Officer immediately. The Contracting Officer and COR shall examine methodologies and quality control procedures during the contract term.

15.2 Performance Standards

15.2.1 Measure: Safety and Integrity of Specimens

Performance Requirement: Maintain integrity of all specimens provided for testing with no loss, degradation, or destruction of specimens.

Standard: No loss or destruction of specimens

Performance Requirement: Reports of lab testing results shall be provided within the TAT listed in the contractor’s laboratory reference test manual per test Standard: Results per test will be reported within the TAT listed in the contractor’s laboratory reference test manual Acceptable Quality Level: 90% Surveillance Method: 100% inspection of 6 randomly selected test codes per month Frequency: Monthly

15.2.3 Measure: Emergency Response Time

Performance Requirement: Specimens provided for testing on an emergency and/ or urgent basis shall be completed within four (4) hours of receipt Standard: Contractor responds within four (4) hours Acceptable Quality Level: 100% Surveillance Method: Direct Observation Frequency: Monthly

16. REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM

16.1 As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the Simplified Acquisition Threshold and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Sea Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information

16.2 Each contractor whose contract award is estimated to exceed the Simplified Acquisition Threshold is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award and must be kept current should there be any change to the contractor’s registered representative.

16.3 For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer.

16.4 Failure to have a current registration in the CPARS database, or to re-assign the report to the VA contracting officer within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the contractor failed to respond.

17. RESPONSIBILITIES:

17.1 OVERSIGHT OF SERVICE/PERFORMANCE MONITORING:

Contract Administration: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to the contracting officer.

17.2 CONTRACTING OFFICER RESPONSIBILITIES:

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of 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 any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

17.2.1 The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is the final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

17.2.2 In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

17.3 COR RESPONSIBILITIES:

17.3.1. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by monitoring procedures shall be forwarded immediately to the Contracting Officer.

17.3.2. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data may be collected for ongoing monitoring.

17.3.3. The COR will ensure that the testing results are available in the patient’s electronic medical record.

17.3.4 The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

17.4 CONTRACTOR RESPONSIBILITIES:

17.4.1. Contractor’s personnel are responsible for performance of all reference laboratory testing in accordance with the terms of the enclosed Performance Work Statement.

17.4.2. The Contractor shall provide a written statement quarterly to the Chief, PLM&S regarding a summary of performance. The report shall be submitted directly to the Contracting Officer’s Representative who shall distribute to the appropriate parties. The report shall be submitted no later than the 10th calendar day of each month.

Comprehensive Listing of Histocompatibility Testing Required by VA Tennessee Valley Healthcare System Department of Pathology

Test Name

Typing

HLA Complete Typing: High Resolution (HLA-A,B,C,DR,DRB3/4/5,DQ,DP)

HLA-A,B, and DRB1 Verification typing

Deceased Donor Workup - Import

HLA-Class I typing: Low resolution (HLA-A,B,C)

HLA Class II typing: Low resolution (HLA-DRB1/3/4/5 and DQB1)

HLA Class I - one locus, Low resolution (HLA-A,B, or C)

HLA-Class II, one locus, Low resolution (HLA-DR,DQ, or DP)

HLA-A locus - High Resolution

HLA-B locus - High Resolution

HLA-C locus- High Resolution

HLA Class II typing, one locus: High resolution (each locus)

HLA-DPB1 locus - High resolution + DPA1

HLA-DRB1 +DRB3/4/5, Low resolution

HLA-DRB1 typing - High resolution + DRB3/4/5

HLA-DQB1 - Low resolution

HLA-DQB1 locus - High resolution + DQA1

ABO

ABO - reverse typing only

A1 Titer

A1 Titer (No Donor)

HLA Antibody testing

HLA Class I antibody screen - Flow Cytometry

HLA Class II antibody screen - Flow Cytometry

HLA Class I and Class II antibody screen - Flow cytometry

HLA Class I & Class II Antibody Screen - (Luminex)

HLA Class I Antibody ID- Luminex Single Antigen panel

HLA Class II Antibody ID- Luminex Single Antigen panel

HLA Class I Antibody ID- Luminex Single Antigen panel- Immucor

HLA Class II Antibody ID- Luminex Single Antigen panel- Immucor

HLA Class I Antibody- semi-quantitative panel (eg. Titer)

HLA Class II Antibody- semi-quantitative panel (eg. Titer)

HLA Class I Antibody ID with C1q binding- Luminex

HLA Class II Antibody ID with C1q binding- Luminex

Crossmatching

T Cell crossmatch - cytotoxic/AHG

Flow cytometry crossmatch - (T and B cell)

Flow cytometryAuto-crossmatch - (T and B cell)

T Cell crossmatch-Cytotoxic /AHG (no charge to donor)

Flow Cytometry Crossmatch (T & B cell) - no charge to donor

B Cell crossmatch- cytotoxicity (no charge to donor)

T Cell crossmatch- Cytotoxic/AHG (charge to recipient serum)

Flow Cytometry Crossmatch - T & B cell (charge to recipient serum)

B Cell Crossmatch -Cytotoxic (charge to recipient serum)

T & B Cell Cytotoxic Crossmatch

T & B Cell Cytotoxic Crossmatch- No Charge to Donor

T & B Cell Cytotoxic crossmatch -(charge to recipient serum)

Flow Crossmatch with Titers

Miscellaneous

Serum Archive

DNA Extract and Hold

Sendout Kit

International Sendout Kit

Miscellaneous Call pay - (1-4hours)

Flow PRA STAT charge

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