PWS.pdf

Performance Work Statement (PWS)

Title: Tissue Typing and Immunogenetics Laboratory Services.

1. General

1.1. Introduction:

The mission of James J. Peters VA Medical Center (JJP VAMC) renal transplant program is to provide leading-edge, empathetic lifesaving care for veterans who are kidney transplant recipients at every phase of their transplant journey. The Contractor shall provide Comprehensive Tissue Typing and Immunogenetics Laboratory Services.

1.2. Background

The James J. Peters VA Medical Center, at 130 Kingsbridge Road, Bronx, New York 10468, Renal Transplant Program requires services that are vital to patient care and seeks to procure the specialty of tissue typing and immunogenetic laboratory. This testing is essential to properly match organ donors with recipients, to decrease rejection and increase longevity of graft function. This tissue typing is also critical to diagnosing and preventing transplant rejection.

This PWS establishes the requirements for a Contractor to provide a full range of tissue typing and immunogenetics laboratory services. These services are crucial for supporting a solid organ and/or hematopoietic stem cell transplantation program, as well as for disease association studies and transfusion support. The services will involve complex and specialized testing to determine compatibility between donors and recipients, and to monitor immunologic complications.

1.3 Objective

To provide high-quality, reliable, and timely immunogenetics laboratory services to support clinical care for JJPVAMC transplant center.

The Contractor shall perform all required tests, analyze data, and report results in accordance with industry standards, regulations, and the performance metrics outlined in this PWS.

1.4 Place of Performance –

All work will be performed at the Contractor’s facility.

1.3. Period of Performance –

The period of performance is five years. The contractor shall provide the deliverables required under this Statement of Need within 15 calendar days or less from the date of the award, unless otherwise directed by the Contracting Officer.

1.4 Scope of Work

The Contractor must prioritize veteran patients even during high-volume periods.

https://www.bing.com/ck/a?!&&p=f186a65a839940e4ad39d3106e95966c6353028a6d7540fb275fc9315de45afdJmltdHM9MTc1MDgwOTYwMA&ptn=3&ver=2&hsh=4&fclid=2bf90fa1-a241-621a-00cc-1ad2a3f663ce&u=a1aHR0cHM6Ly93d3cua2Vja21lZGljaW5lLm9yZy9jZW50ZXJzLWFuZC1wcm9ncmFtcy9raWRuZXktdHJhbnNwbGFudC8&ntb=1 https://www.bing.com/ck/a?!&&p=f186a65a839940e4ad39d3106e95966c6353028a6d7540fb275fc9315de45afdJmltdHM9MTc1MDgwOTYwMA&ptn=3&ver=2&hsh=4&fclid=2bf90fa1-a241-621a-00cc-1ad2a3f663ce&u=a1aHR0cHM6Ly93d3cua2Vja21lZGljaW5lLm9yZy9jZW50ZXJzLWFuZC1wcm9ncmFtcy9raWRuZXktdHJhbnNwbGFudC8&ntb=1 https://www.bing.com/ck/a?!&&p=f186a65a839940e4ad39d3106e95966c6353028a6d7540fb275fc9315de45afdJmltdHM9MTc1MDgwOTYwMA&ptn=3&ver=2&hsh=4&fclid=2bf90fa1-a241-621a-00cc-1ad2a3f663ce&u=a1aHR0cHM6Ly93d3cua2Vja21lZGljaW5lLm9yZy9jZW50ZXJzLWFuZC1wcm9ncmFtcy9raWRuZXktdHJhbnNwbGFudC8&ntb=1

The Contractor must provide after-hours and emergency testing when needed.

The Contractor shall provide all personnel, materials, equipment, and supervision necessary to perform all required tissue typing and immunogenetics services. The Contractor is responsible for all aspects of the testing process, including specimen receipt, testing, analysis, and reporting.

The tissue typing lab will provide 24/7, 365 days coverage as requested by JJP VAMC renal transplant team. It will process and as needed, store the sera of all recipients and living donors at JJPVAMC.

Crossing match testing will be done on deceased and living organ donors matched with JJPVAMC recipients. Recipients who are listed will need to bank their sera monthly so potential donors can be tested against recipient sera as offers are made. For post-transplant patients this laboratory will be vital in the management of antibody mediated rejection. These tissue tests are essential components of transplant medicine and are the most important indicators of quality and predict transplant longevity and success.

1.5 Delivery Schedule

The Contractor shall provide service for transplantation to determine HLA matching, sequence-level HLA matching between patient and donor for solid organ transplantation and identify specific HLA types required for vaccine and immunotherapy 24 hours a day, seven days a week (24/7), in which includes all federal holidays.

On call staff shall be available 24/7 for emergency testing upon request. On call schedule shall be provided minimum 24hrs ahead of JJPVAMC transplant program. IGT will perform and report all phrases of transplant lab work requirements.

Turnaround testing and results for Histocompatibility tissue typing and immunogenetics lab services must be within four (4) hours for all IGT testing

Federal Holidays:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

And any day declared by the President as a Holiday.

2.0 Performance requirements

2.1 Histocompatibility testing for solid organ transplantation

The Contractor shall provide Human Leukocyte Typing (HLA) typing and compatibility services to support deceased and living donor solid organ transplants.

HLA Typing:

Required Outcome: Perform high-resolution typing for Human Leukocyte Antigen (HLA) loci A, B, C, DRB1, DRB3/4/5, DQA1, and DQB1 for all prospective donors and recipients.

Performance Standard:

Achieve the defined resolution level (e.g., high-resolution using Next-Generation Sequencing (NGS) or Sequence-Based Typing (SBT)) with a minimum of two separate typing tests for all deceased donors.

Acceptable Quality Level (AQL):

99.9% accuracy on all reported HLA typing results.

Antibody Screening and Identification:

Required Outcome: Screen recipient serum for HLA antibodies and identify specificity, including donor-specific antibodies (DSA).

Performance Standard: Perform antibody screening using approved methods (e.g., Luminex single antigen beads). Results will be interpreted and reported according to standard protocols. Turnaround time for STAT DSA must be adhered to less than 4 hours.

AQL: All HLA antibody reports must be reviewed and approved by a qualified supervisor or director before release.

Crossmatching:

Required Outcome: Provide physical and/or virtual crossmatching services, plus antibody screening for donor-recipient pairs.

Performance Standard: Turnaround time for STAT virtual crossmatches must be adhered to less than 2 hours; Turnaround time for STAT crossmatches including antibody screening for donor-recipient pairs must be adhered to less than 4 hours.

AQL: All crossmatch plus antibody screening for donor-recipient pairs results must be reported verbally for STAT cases, followed by a final written report.

Post-transplant monitoring:

Required Outcome: Monitor for donor-specific antibodies (DSA) and perform specific immunologic tests (e.g., C1q, MICA) as requested.

Performance Standard: Deliver results within the agreed-upon turnaround time for routine and STAT cases and all results will be reported with clear interpretive guidance.

2.2 Specimen handling and management

Required Outcome: Handle all patient and donor specimens safely and securely, ensuring proper identification, storage, and transport.

Performance Standard:

Receipt: All specimens must be logged in with matching patient information on the request form and tube.

Labeling: Specimens must include the patient's name, unique identifier, and date of collection.

Transport: The Contractor shall provide appropriate packaging and shipping materials that meet biological and temperature requirements.

Storage: Store samples for a defined period (e.g., as per the written agreement) to allow for re-testing if necessary.

AQL: Zero incidents of specimen mix-up or misidentification.

2.3 Reporting and communication

Required Outcome: Deliver test results and communicate critical findings accurately and in a timely manner, within 4 hours.

Performance Standard:

Content: Reports must include the patient/donor’s name and unique identifier, test results, methodology used, and reference ranges.

Delivery: Verbal reporting for STAT tests followed by a written report (fax or secure electronic transmission).

Discrepancy Resolution: Report any HLA typing discrepancies or errors to the designated client representative within a defined timeframe.

AQL: 100% of STAT results verbally reported within the specified timeframe.

3.0 Quality assurance and controls

3.1 Quality control plan

The Contractor shall maintain an effective Quality Control Plan (QCP) to ensure the accuracy and reliability of all services performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is how the contractor assures itself that its work complies with the requirement of the contract.

3.2 External proficiency testing

The Contractor shall participate in External Proficiency Testing (EPT) programs for all accredited applications, including HLA typing, antibody screening, and crossmatching.

3.3 Compliance

The Contractor shall be accredited by relevant authorities (e.g., American Society for Histocompatibility and Immunogenetics [ASHI]) and adhere to all relevant regulations, including those from the Organ Procurement and Transplantation Network (OPTN).

4.0 Government-furnished property

The Government will not furnish any property or equipment. The Contractor shall provide all necessary resources to perform the services.

5.0 Deliverables

The Contractor shall provide the following deliverables:

• Monthly status report(s) summarizing all services performed.

• Completed test reports for all requested services.

• The Quality Control Plan (QCP), submitted within 10 business days of contract award and updated annually.

• Proof of participation and results from all External Proficiency Testing programs.

• The contractor must meet the critical four-hour turnaround time for transplant crossmatching and HLA typing results despite their institution workload.

6.0 Performance surveillance

• The Government will conduct surveillance to ensure the Contractor is meeting the performance standards. This will be outlined in a separate Quality Assurance Surveillance Plan (QASP).

• The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

7.0 Comprehensive Contingency Plan

The Contractor shall provide a comprehensive contingency plan to address potential service interruptions. This plan should include:

• Identification of alternative vendors or labs that can provide interim services.

• Procedures for emergency communication and coordination with our medical center.

• Logistics management for urgent sample transfers.

• Documentation and training protocols for quick implementation of contingency measures.

• Regular reviews and updates of the contingency plan to adapt to evolving circumstances.

8.0 Security and privacy

The Contractor shall be fully compliant with all relevant security and privacy regulations, including the Health Insurance Portability and Accountability Act (HIPAA).

8.1 Protected Health Information (PHI) or Access Control: The Contractor shall implement role-based access controls to limit access to PHI only to authorized personnel.

Encryption: The Contractor shall use encryptions for all electronic PHI (ePHI) at rest and in transit.

• Data Handling: The Contractor shall enforce policies for the secure handling of all patient and donor data.

• Breach Notification: The Contractor shall have a documented incident response plan and follow all HIPAA breach notification requirements.

• Staff Training: The Contractor shall ensure all staff interacting with PHI receive regular and documented training on HIPAA and data security best practices.

9.0 Contractor qualifications

• The Contractor must be a laboratory fully accredited by ASHI and CLIA-certified.

• The laboratory director must be a diplomate of the American Board of Histocompatibility and Immunogenetics (ABHI) or a similarly qualified and approved individual.

• All personnel performing testing and analysis must be appropriately qualified and trained according to ASHI standards.

10.0 Certifications, Licensing, and Training

The Contractor shall provide proof of Clinical Laboratory Improvement Amendments (CLIA) Certification, American Society for Histocompatibility and Immunogenetics (ASHI) Accreditation, College of American Pathologists (CAP) Accreditation, FDA Certification, American Board of Medical Genetics and Genomics (ABMGG), Continuing Education and Training, State Laboratory License, and Professional Licenses.

11.0 Contracting Officer Representative (COR)

The (COR) will be identified by the COR Appointment Document. The COR monitors all technical aspects of the contract and is responsible for technical oversight, monitoring contractor performance, and documenting compliance with the PWS. The letter of appointment issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR. The COR is not authorized to change any of the terms and conditions of the contract, especially regarding changes in cost or price, estimates or changes in delivery dates. Doing so will create an unauthorized commitment.

12. Non-Compliance

The Contracting Officer or his/her designee will notify the contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his/her representative at the site of the work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all and any part of the work and hold the Contractor in default.

13. Other Related Services (Not Included in the Scope of Work)

Any services not expressly stated in the performance work statement are not authorized.

Additional services deemed vital to the continued functioning of the systems or performance of the work herein may be added only after written modification from the contracting officer, unless they are inclusive to the requested services. No other person, including the COR or other VA personnel are authorized to request additional work be performed by the contractor. Any additional services performed that are not authorized by the contracting officer will be considered inclusive.