Draft PWS for Transplant Laboratory Testing HOU.pdf

PERFORMANCE WORK STATEMENT (PWS)

Transplant Laboratory Testing

Michael E. DeBakey VA Medical Center (“MEDVAMC”)

2002 Holcombe Boulevard

Houston, TX 77030

1. GENERAL: This is a non-personnel services contract to provide histocompatibility testing and other transplant-related immune evaluation testing needed to confirm transplant candidacy for Veterans at the Michael E. DeBakey VA Medical Center (“MEDVAMC”). The MEDVAMC shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to MEDVAMC. As a tertiary care medical center and a stand-alone

VA transplant center the MEDVAMC has the transplant expertise to take care of Veterans with organ failure, has on-site highly successful United Network for Organ Sharing (“UNOS”) – approved kidney and liver transplant programs, was recently approved by the National Surgery

Office (“NSO”) to start a heart transplant and left ventricular assist device programs (catering to

Veterans from all over the country), which further enhances the acuity of care provided at the

MEDVAMC.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, tools, materials, and supervision necessary to perform histocompatibility tests and other transplant-related immune evaluation tests. The contractor shall perform to the standards in this contract.

1.2 Scope: The contractor shall provide all histocompatibility testing and other transplant-related immune evaluation testing needed to confirm transplant candidacy for Veterans at the

1.3 Period of Performance: The period of performance shall be for one (1) 12 Month Base Year and four (4) 12-month option years. The Period of Performance reads as follows:

Base Year: 04/1/2026 – 03/31/2027

Option Year I: 04/1/2027 – 03/31/2028

Option Year II: 04/1/2028 – 03/31/2029

Option Year III: 04/1/2029 – 03/31/2030

Option Year IV: 04/1/2030 – 03/31/2031

*Dates above are tentative and may be subject to change

1.4 Hours of Operation: Contractor MUST ensure adequate staffing to always provide continuous diagnostic and reporting capabilities for all histocompatibility test services (24 hours/day), on a year-round basis (365 days a year), as well as the pickup of samples from the

MEDVAMC. In addition, the laboratory shall provide continuous 24/7 accessibility to a staff that specializes in transplant diagnostic testing to discuss clinical implications of the reported test(s).

1.5 Place of Performance: The work to be performed under this contract will be performed at the

Contractors Histocompatibility Testing Lab. The HLA Lab MUST be located within the

Houston, TX geographic area due to the time-sensitive nature of these tests. Delays in any of these processes can reduce the quality of the transplanted organ. Early placement of organs after donation results in best patient and graft outcomes for our Veterans.

1.6 Type of Contract: The Veterans Affairs will award a Firm Fixed Price Contract based off

Technically Acceptable (see evaluation criteria) Lowest Cost criteria.

2. MEDVAMC FURNISHED ITEMS AND SERVICES:

2.1 The Contracting Officer’s Representative (“COR”) assists the Contracting Officer (“CO”) by monitoring compliance with all contract terms and conditions. The contractor shall be required to complete and return the COR Delegation of Responsibilities form to the Contracting Officer.

This memorandum clearly states the role, responsibilities, and limitation of authority imposed on the COR. Only the Contracting Officer shall have the authority to negotiate changes or to modify the contract. The COR is not authorized in any way to commit the Government.

2.2 Services: The MEDVAMC send out laboratory personnel will affix a label containing the patient’s full name and full social security number to the specimen’s container in order to ensure integrity of the information, place the specimen in a sealed tamper evident container and prepare it for pickup/delivery. Once prepared the MEDVAMC personnel will:

a. Call the contractor and notify the contractor that the specimen is ready for pickup or

b. Call the courier that is on contract to arrange immediate pickup and direct delivery to the

HLA testing Lab.

3. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

3.1 General: Contractor shall furnish all supplies, equipment and services required to perform work under this contract that are not listed under Section 2 of this PWS.

4. Specific Tasks:

4.1 Contractor shall provide the transplant care and tests needed to confirm candidacy for

Veteran beneficiaries of the Department of Veterans Affairs at the MEDVAMC.

4.2 Contractor shall provide daily and stat pickup of transplant samples from the MEDVAMC.

a. The contractor shall pickup and deliver Transplant Laboratory Specimens as needed upon request.

b. The contractor shall ensure that the specimen transportation container will be in compliance with the regulations as established by the Department of Transportation.

c. The contractor shall ensure that the specimen transport is conducted in a manner to maintain acceptable specimen temperatures.

d. The contractor should ensure that specimen confidentiality is maintained in accordance with all applicable rules and regulations.

e. The contractor shall ensure that the personnel picking up and transporting specimens wear uniform and identification.

4.3 The Contractor must be approved by:

a. The Medicare Program

b. The College of American Pathologists (“CAP”)

c. The United Network of Organ Sharing (“UNOS”).

4.4 Contractor shall provide services in a manner that:

a. assures consistency of histocompatibility testing services, quality control, and patient safety;

b. assures adequate staffing to always provide continuous availability of histocompatibility testing and reporting services, on a year-round basis.

c. provides effective administration of the histocompatibility testing services and development of effective policies and procedures for implementation of quality services;

d. development of effective policies and procedures for implementation of quality services;

e. An expert from the HLA lab must attend the weekly transplant medical review board meeting at the MEDVAMC in-person to discuss the results tests and participate in the committee’s decision for patient selection;

f. expedites the scheduling of patients and assures that the needs of patients take precedence; and

g. An expert who specializes in Transplant Diagnostic testing shall be available 24/7 to discuss the clinical implications of the reports with the transplant nephrologist and transplant surgeon(s).

4.5 Contractor shall include, but not be limited to, professional histocompatibility testing and immune evaluation services requested by the MEDVAMC as described in Exhibit A:

a. Testing schedule may be altered as determined appropriate by the attending transplant physician or the contractor’s HLA Lab Director (the “Director”) after review and approval of attending transplant physician.

b. As requested by the transplant team at MEDVAMC, the Contractor shall perform virtual crossmatch and actual crossmatch testing and shall verbally report in a timely manner to the MEDVAMC transplant team when completed.

c. Results for testing performed by the Lab will follow the turnaround time schedule attached hereto as Exhibit A.

d. “On-Call” contact names and numbers shall be provided monthly to the MEDVAMC’s

Transplant Service.

e. The Lab will adhere to the above paradigm unless additional testing is requested with a specific sample.

4.6 Contractor shall submit invoices monthly in arrears covering the services performed under this contract. The Contractor shall provide an itemized invoice to the required VA invoicing address or submission online through the appropriate website within 30 days of the end of each month services were provided. Invoices for services provided in the month of September must be received for certification no later than October 30th.

a. The invoices shall contain the following information at a minimum:

i. Contract Number

ii. Purchase Order

Number

iii. CPT Code

iv. Test Description

v. Quantity

vi. Price

4.7 Contractor shall provide and ensure safe, secure, and careful handling of the patient samples and the reporting of results in accordance with the guidelines established from:

a. Department of Veterans Affairs Handbook 6500

b. Health Insurance Portability and Accountability Act of 1996

c. Joint Commission on Accreditation of Health Care Organizations

d. College of American Pathologists (CAP)

4.8 Contractor shall develop and provide performance monitoring using the Quality Assurance

Surveillance Plan (QASP).

4.9 Contractor shall have a member of the histocompatibility lab actively participate in the transplant program’s Quality Assurance and Performance Improvement (QAPI) meeting at

4.10 Contractor shall provide the following Transplant Laboratory Testing listed in the contract within the allotted turnaround times (“TAT”) shown as Exhibit A.

5. APPLICABLE PUBLICATIONS (CURRENT EDITIONS):

5.1 The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures. All work shall be performed in accordance with the Human Leukocyte

Antigen (“HLA”) testing guidelines as established by UNOS.

6. PERFORMANCE REQUIREMENT SUMMARY:

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

(The Service required – usually a shall statement)

Standard Performance Threshold

(This is the maximum error rate. It could possibly be “Zero deviation from standard”)

Method of

Surveillance

Contractor shall attend the weekly transplant Medical Review Board (MRB) at the MEDVAMC

In person 100% attendance Meeting Sign in Sheet

Contractor shall attend the monthly

Quality Assurance and Performance

Improvement (QAPI) meeting at the

MEDVAMC

In person 100% attendance Meeting Sign in Sheet

Contractor shall attend the Ad hoc living donor swap meeting at the MEDVAMC In person 100% attendance

Meeting Sign in Sheet

Contractor shall follow TAT Schedule 100% compliance Submission of

TAT Report

Contractor shall follow MEDVAMC

Transplant Testing Protocols 100% compliance

Verify monthly invoice

7. DELIVERABLES SCHEDULE:

Deliverable Frequency # of Copies Submit To

Professional participation in the MRB meeting Weekly N/A N/A

Professional participation in the QAPI meeting Monthly N/A N/A

Deliverable Frequency # of Copies Submit To

TAT Report Monthly 1

MEDVAMC

Transplant Director

EXHIBIT A

MEDVAMC Acceptable Turn Around Times

EXHIBIT B

MEDVAMC TURN AROUND TIME (“TAT”) SCHEDULE

PURPOSE: To provide the Lab’s TAT for each test and what steps are taken if that is not met.

DEFINITION: Turn Around Time is based from the time that the specimen is received by the

Laboratory until the test results are received by the MEDVAMC Transplant personnel.

PRINCIPLE: TAT charts have been developed by the Lab and distributed to transplant centers.

The TAT charts also include correct specimen collection details for various assays.

PROCEDURE

• Monthly random spot checking for TATs will be documented for all assays performed by the Lab. Different assays have different TATs and criteria have been established in all

Laboratory Sections to not exceed these times.

• When the TAT is not expected to be met, the technologist running the assay must inform the laboratory supervisor and the appropriate Hospital transplant coordinator.

• The incident is recorded in the Quality Management TAT logbook with the date, sample name, assay performed, and reason the TAT was not met.

• The logbook is to be reviewed monthly by the laboratory supervisor and Hospital leadership, and corrective action will be taken as necessary.

TAT CHARTS / PATIENT REQUIREMENTS

TEST TUBES TO COLLECT TURN AROUND TIME

HLA Typing

(A, B, C, DR1, DR3,4,5

DQA, DQB, DPA, DPB)

4- (10cc) ACD tubes 1-5 business days

10 days for sequencing

Flow PRA 1- (10cc-clot) red top 1-5 business days

Antibody ID or

Antibody ID titrations 1- (10cc-clot) red top 5 business days

Crossmatches:

Flow Cytometry and AHG

(recipient) 1-(10cc-clot) red top

(donor) 4-(10cc) ACD tubes 1-5 business days

Virtual XMs none Prior to actual XMs

*Specimen receipt time will affect reporting time.

**For Pedi patients-please use your professional judgment for draws.

DECEASED DONOR REQUIREMENTS:

TEST TUBES/SPECIMEN TURN AROUND TIME

Crossmatches:

Full visual and Pre-TX

From recipient

1-(10cc-clot) red top

Technologists on-call will estimate the time, and inform OPO (approx. 6 hrs.)

Virtual XMs None Prior to actual XMs

Reference: ASHI Standards D.6.1.3

EXHIBIT C

MEDVAMC Transplant Testing Protocols: Kidney, Dual Organ with Kidney Testing

EVALUATION

4-10cc ACD tubes AND

1-10cc clot red

HLA-A,B, C

HLA-DR, DQ, DP

Flow PRA CI & CII

(reflex) Ab Spec/ID (CI or CII or both)

(when ordered) C1q (CI or CII or both)

PRE-TX

(re-TX or Reprofile)

4-10cc ACD tubes AND

1-10cc clot red top

HLA-A, B, C (if needed)

HLA-DR, DQ, DP (if needed)

Flow PRA CI & CII

(reflex) Ab Spec/ID (CI or CII or both)

(when ordered) C1q (CI or CII or both)

New Living

Donor Evaluation 4-10cc ACD tubes

HLA-A, B, C

HLA-DR, DQ, DP

XM with Living

Donor

Recipient: 1-10cc clot red top

Donor: 4-10cc ACD tubes

Flow XMs (T & B) (historical &/or current

&/ or pre-tx)

(reflex if Flow XM is positive) AHG XMs

(historical &/or current &/or pre-tx)

(reflex if Flow XM is positive) T & B XMs

(historical &/or current &/or pre-tx)

(reflex) Flow PRA (if XM sample was not tested previously)

(reflex) Ab Spec/ID (CI or CII or both)

Final XM with

Living Donor

Recipient: 1-10cc clot red top

Donor: 4-10cc ACD tubes

Flow XMs (T & B) (current &/ or pre-tx)

(reflex if Flow XM is positive) AHG XMs

(current &/or pre-tx)

(reflex if Flow XM is positive) T & B XMs

(current &/or pre-tx)

(reflex) Flow PRA (if XM sample was not tested previously)

(reflex) Ab Spec/ID (CI or CII or both)

XMs with

Deceased Donor 1-10cc clot red top

AHG XMs (historical &/or current &/or pre-tx)

Flow XMs (T&B) (historical &/or current

&/or pre-tx)

(reflex) Flow PRA (If XM sample was not tested previously)

(reflex) Ab Spec/ID (CI or CII or both)

VIRTUAL XM Virtual XM

PRE & POST TX

Antibody Monitoring 1-10cc clot red top

Flow PRA CI & CII

(reflex) Ab Spec/ID (CI or CII or both)

(when ordered) C1q (CI or CII or both)

SAVE 1-10cc clot red top Save for future use

EXHIBIT C (cont.)

1. MFIs will be used as cutoff for Unacceptable Antigen listing in UNOS, to be determined by medical/surgical staff.

2. Post-TX unsensitized patients will have no monitoring and testing for donor specific anti-

HLA antibodies will be decided by the Kidney Transplant program. We recommend post-transplant monitoring for donor specific antibodies at 2 weeks, 1 month, 3 months, 6 months, and yearly post-transplant.

3. Post-TX sensitized patients will have antibody monitoring post plasma apheresis, then weekly for one month. We recommend post-transplant monitoring for donor specific antibodies at 2 weeks, 1 month, 3 months, 6 months, and yearly post-transplant.

4. STAT or Virtual XM, AB Spec/ID, or C1q results reported directly to Dr. Etheridge or designee as needed for immediate patient care.

EXHIBIT D

Transplant Testing Protocols: Heart Testing

EVALUATION

1-10cc clot red top

4-10cc ACD tubes

HLA-A, B, C

HLA-DR, DQ, DP

Flow PRA CI and CII

(reflex) Ab Spec/ID (CI or CII or both)

(when ordered) C1q (CI or CII or both)

PRE-TX 1-10cc clot red top

Flow PRA CI & CII

(reflex) Ab Spec/ID (CI or CII or both)

(when ordered) C1q (CI or CII or both)

VIRTUAL XM Virtual XM

Crossmatches

(XM)

1-10cc clot red top

AHG XMs (historical &/or current &/or pre-tx)

Flow XMs (T&B) (historical &/or current

&/or pre-tx)

(reflex) Flow PRA (If XM sample was not tested previously)

(reflex) Ab Spec/ID (CI or CII or both)

POST-TX 1-10cc clot red top

Flow PRA CI & CII

(reflex) Ab Spec/ID (CI or CII or both)

(when ordered) C1q (CI or CII or both)

1. MFIs will be used as cutoff for Unacceptable Antigen listing in UNOS, and C1q positive antibodies, to be determined by medical/surgical staff.

2. Post-TX unsensitized patients will have antibody monitoring (Flow PRA, reflex Ab

Spec/ID) at 1, 2, 3, 6, and 12 months.

3. Post-TX sensitized patients will have antibody monitoring (Flow PRA, reflex Ab Spec/ID, reflex C1q) at weeks 2 and 4 and months 2, 3, 6, and 12. C1q will be performed when ordered by medical/surgical staff.

4. STAT or Virtual XM, Ab Spec/ID, or C1q results reported directly to Dr. Etheridge or designee as needed for immediate patient care.

5. XMs to be performed concurrently with transplant when donor is import, otherwise, pre-tx.

(End of Draft PWS)