PWS.pdf

Performance Work Statement Tissue Typing and Immunogenetics Lab Services

1. General

1.1. Introduction:

The mission of 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.

1.2. Background /Objective –

The James J. Peters VA Medical Center (JJPVAMC), at 130 Kingsbridge Road, Bronx, New York 10468, Renal Transplant Program requires the services is necessary to contract with a specialty 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.

JJP VAMC is acquiring Immunogenetics and Transplantation Laboratory services.

1.3. Place of Performance –

Rogosin IGT ( Immunogenetics and Transplantation Laboratory)

430 East 71st Street

New York, NY 10021

1.4. Period of Performance –

This will be a base plus four possible option years from the date of the award. The contractor shall provide the deliverables required under this Statement of Need with in 15 calendar days or less from date of award, unless otherwise directed by the Contracting Officer.

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 Recognized Holidays: [State if the contractor is required to perform services on holidays.]

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day 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

Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

2. Definitions – None

3. Scope of Work –

The IGT laboratory is open 24 hours a day, seven days a week (24/7). on call staff is available for emergency testing. On call schedule is provided minimum 24hrs ahead.IGT will perform and report all phrases of transplant lab work requirements.

4. Specific Tasks – providing specialized diagnostic services for patients awaiting organ transplants and those requiring post-transplant monitoring

4.1 Task One:

The services included:

• HLA typing of patients and organ donors

• Chimerism testing

• HLA requisition

• Crossmatching

• HLA genotyping

• Antibody testing

• 24-hour on-call service for transplantation

The services provided is 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.

4.1. Task Two - Contractor shall furnish all tissue typing and immunogenetics laboratory services to as soon as possible and provide report when it is made available.

4.2. Task Three - Continue this for all tasks to be performed.

4.3. Task Four – Provide on call schedule to JJP VAMC renal transplant team minimally within 24hours of the day via formal communication.

5. Delivery Schedule or Deliverables –

The IGT laboratory is available seven days a week (24/7). IGT on-call staff is available for emergency testing 24 hours a day.

6. Drawings, and Other Attachments – Are there drawings, specifications, tables, pictures, one lines, blueprints, included to assist in completion of work. Delete this section if it does not apply.

7. Quality Control – The contractor shall develop and maintain an effective quality control program to ensure services are 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 the means by which he assures himself that his work complies with the requirement of the contract.

8. Quality Assurance – 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).

9. Contracting Officer Representative (COR) – The (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

10. Special Instructions – Instructions regarding arrival, access, check-in, interaction in patient areas, and safety requirements. This includes adherence to Federal, State, local and other directives.

publications or regulations. This includes a notice of how failure to meet compliance with special instructions. Must state specifically which directives publications, and regulations to which we expect adherence. I recommend a statement that the contractor shall include any applicable directives, publications or regulations not listed that are required that may have been omitted from the list.

11. Meetings – If any site visit, kickoff meetings, or routine progress meetings

12. Required Travel – A statement as to how the contractor expects to accomplish the requirement of being present at the times/intervals required to complete the work.

13. Non-Compliance – The following statement is a good template to address 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.]

14. Phase In / Phase Out Period (If applicable) – To minimize any decreases in productivity and to prevent possible negative impacts on additional services, the Contractor shall have personnel on board, during the [Insert the period, i.e., sixty (60) day, thirty (30) day, etc.] phase in/phase out periods. During the phase in period, the Contractor shall become familiar with performance requirements to commence full performance of services on the contract start date. Delete this section if it does not apply.

15. 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.