36C24818R0879-003.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN

For: Pathology & Laboratory Medicine Service

Contract Number: Blood Compatibility Testing

Contract Description: Contractor shall provide, on a 24 hour, 7 day a week basis, all blood transfusion and transfusion-related services, including without limitation, compatibility testing, and all personnel, supplies and equipment therefore. Such services shall be provided to the Jame A. Haley VA Medical Center and Orlando VA Medical Center, as needed, according to acceptable AABB Accreditation Standards, including emergency situations. Compatibility testing shall be defined to include all crossmatching, all type and screen, all antibody identifications, all antibody elutions, and all reference laboratory workups.

Contractor’s 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 assure 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: Cyrouse Houshyani Organization or Agency: Network Contracting Office – VISN 8

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure 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.

Orlando VAMC Assigned COR (Primary): Esther W. Murphy Alternate COR: Michael Colon

Tampa VAMC Assigned COR (Primary): Linda Carr

c. Other Key Government Personnel – Hussein R. Hameer, MD, Transfusion Committee Chairman

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 ______________________

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 Matrix, paragraph 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).

Task ID Indicator Standard Acceptable Quality Level

Method of Surveillance

Quality of Services

Quality of

Services

1 Timeliness Of Service

Routine requests will be completed within 8 hours. STAT requests will be completed within one hour.

95%

Routine and

STAT

requests for blood will be monitored for timeliness

Number of transfusion reactions

All transfusion reactions must be investigated by contractor and provide copies of the workup and interpretation.

95%

Results reported at the monthly Transfusion Committee meeting.

Attendance at the monthly Transfusion Committee meeting

A technical and a medical representative is required to attend the monthly meeting.

One representative or both are required to attend 75% of the meetings.

Transfusion Committee meeting minutes.

4 Accuracy of Billing

Invoices must accurately reflect services provided by the contractor

95% accuracy

Billing discrepancies must be corrected within 90 days.

Billing statement will be checked against services performed.

5. INCENTIVES: The Government shall use Exercise of Option Period and past performance and/or any other incentive that was proposed in your solution 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.)

b. PERIODIC INSPECTION (Evaluates outcomes on a periodic basis. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.)

c. PERIODIC SAMPLING (Variation of random sampling. However, sample is only taken when a problem/deficiency is suspected. Sample results are applicable only for the specific work inspected.

Since sample is not entirely random, it cannot be applied to total activity performance.)

d. Progress or status meetings.

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:

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’s 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 shall 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.

1. Exceeds Standard

2. Meets Standard

3. Failed to Meet Standard

b. Frequency of Performance Assessment Meetings - The COR shall meet with the contractor monthly to assess performance and shall provide a written assessment.

Signature – Contractor Program Manager

Signature – Contracting Officer’s Representative

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