Attachment D.4 QASP.pdf

RFP 36C25626R0027 Attachment D.4 - QASP

QUALITY ASSURANCE SURVEILLANCE PLAN

For: Human Leukocyte Antigen (“HLA”) Testing for Transplant care and tests needed to confirm candidacy for Veteran beneficiaries of the Department of Veterans Affairs at the MEDVAMC.

Contract Number: < Upon award, Government will enter contract number>

Contract Description: The contractor shall provide all personnel, equipment, supplies, tools, materials, and supervision necessary to perform Human Leukocyte Antigen (“HLA”) Testing for Transplant care and tests needed to confirm candidacy for Veteran beneficiaries of the Department of Veterans Affairs. The contractor shall perform to the standards described in the Performance Work Statement included in this contract.

Contractor’s name: <Enter your company name.> (hereafter referred to as the contractor).

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

• What will be monitored.

• How monitoring will take place.

• Who will conduct the monitoring.

• How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor.

Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO: Contracting Officer (CO) – Ashely M. Haslauer Contract Specialist (CS) – Steven A. Berkeley Organization or Agency: MEDVAMC’s Pathology & Laboratory Medicine

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall ensure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: Bernita Hudson, Pathology and Laboratory Medicine Service (PLMS) Management and Program Analyst

c. Other Key Government Personnel:

• Michael M. Ittmann, M.D.; Pathology and Laboratory Medicine Service Executive

• Rafael Andujar; Laboratory Manager

• Bernita Hudson, Management & Program Analyst/COR

• Venkat Ramanathan MD, Director for the Solid Organ Transplant Program and Living Donor Transplant Program

• Priscilla Sloan RN, Solid Organ Transplant Program Manager

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

a. Program Manager –

b. Other Contractor Personnel - <Enter name(s) or delete these lines if not applicable> Title: <Enter title(s) or delete these lines if not applicable.>

4. PERFORMANCE STANDARDS

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Performance Requirements Summary, section 6 in the Performance Work Statement (PWS), includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Measure

PWS

Reference Performance Requirement Standard

Acceptable Quality Level

Surveillance Method Incentive

Key Personnel Paragraph 4.2 section “a, b, c, d, & e”

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

MEDVAMC

Professionalism of Transport/Courier personnel (wear a uniform & must have visible identification), maintaining specimen viability, patient confidentiality

100% Favorable contactor performance evaluation.

Key Personnel Paragraph 6 Contractor shall attend the weekly transplant Medical Review Board (MRB) at the MEDVAMC

Contractors will attend in person and professionally participate

100% Meeting sign in sheet

Favorable contactor performance evaluation.

Key Personnel Paragraph 6

Contractor shall attend the monthly Quality Assurance and Performance Improvement (QAPI) meeting at the

MEDVAMC

Contractors will attend in person and professionally participate

100% Meeting sign in sheet

Favorable contactor performance evaluation.

Key Personnel Paragraph 6 Contractor shall attend the Ad hoc living donor swap meeting at the

MEDVAMC

Contractors will attend in person and professionally participate

100% Meeting sign in sheet

Favorable contactor performance evaluation.

Key Personnel Paragraph 6 Contractor shall follow TAT Schedule See TAT schedule in PWS 100%

Contractor to provide documented evidence

Favorable contactor performance evaluation.

Key Personnel Paragraph 6 Contractor shall follow MEDVAMC Transplant Testing Protocols

HLA testing and cross match per standard protocol

100% Favorable contactor performance evaluation.

Applicable Publications

Paragraph 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 HLA testing guidelines as established by

UNOS.

Refer to Policy 4 at OPTN https://optn.transplant.hrsa.gov/ media/1200/optn_policies.pdf

100%

Contractor to provide documented evidence

Favorable contactor performance evaluation.

Mandatory Training

Paragraph 4.7 section “a”.

Contractor completes all mandatory required training

Contractor will complete all required training per MEDVAMC policy

100%

Contractor to provide documented evidence

Favorable contactor performance evaluation.

Privacy, Confidentiality and HIPPA

Paragraph 4.7 section “a, b, c, & d”.

Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPPA and complies with all standards

Zero breaches of privacy or confidentiality

100%

Contractor to provide evidence of annual training required by VAMC, reports violations per policy

Favorable contactor performance evaluation.

https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf

Timely Invoicing

Paragraph 4.6 section “a”.

Within 30 days of the end of each month services were provided, as described above, the vendor shall provide itemized invoicing

All itemized invoices provided within 30 days of end of each month services delivered

100% Periodic Sampling and Inspection

Favorable contactor performance evaluation.

5. INCENTIVES

The Government shall use recognition in the contractor’s Past Performance Record as incentives.

Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance)

• Patient safety incidents must be reported to Priscilla Sloan RN, by fax, phone call or email (information will be provided after the award of contract).

b. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies.

Complaints are then investigated and validated.)

• Complaints about the quality of service will be reported to the COR and/or the Laboratory Manager for a resolution.

c. RANDOM SAMPLING. (Designed to evaluate performance by randomly selecting and inspecting a sample of cases.)

• Random sampling of test reports will be reviewed to check for timeliness of reporting of tests

• Timely Invoicing

d. CONTRACTOR PROVIDED DOCUMENTATION. (Relies on documentation provided by the contractor).

• Mandatory Training

• Privacy, Confidentiality, HIPAA

• Medicare Program Approval Documentation

• College of American Pathologists Approval Documentation

• United Network of Organ Sharing Approval Documentation

8. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Exceeds: 2-5% above acceptable level in table above Meets: Reach acceptable level in table above Does Not Meet: 5% or more below acceptable level in table above

9. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor should correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

10. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.

During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR meet with the contractor every quarter to assess performance and shall provide a written assessment.

Signature – Contractor Program Manager

Signature – Contracting Officer’s Representative