36C26319R0139-002.pdf

Quality Assurance Surveillance Plan

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 accomplished the work. Rather, a 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 Governments 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 the Government Officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities:

▪ 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 received impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor performance.

▪ Contracting Officers Technical Representative (COR) – The COR is responsible for the technical administration of the contract and shall assure proper Government surveillance of the contractors’ performance. The COR shall keep a quality assurance file. The COR is not empowered to make contractual commitments or to authorize any contractual changes on the Governments behalf.

Assigned CORs: Amy Colbaugh

3. PERFORMANCE STANDARDS

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

Action/Test/Report Turnaround time (TAT) Acceptable Performance

Stat test for drug levels (amikacin, tobramycin, methotrexate, beta-2-transferrin levels, Amytriptyline, Nortrytyline, Everolimus, Procain, NAPA)

Within 4 hours of specimen receipt.

80% of all stat tests submitted

Urgent drug levels (cyclosporine, Sirolimus, tacrolimus)

Within 24 hours of specimen receipt.

80% of all urgent tests submitted

Quantitative Cryoglobulin levels with identification

Within 7 days of specimen receipt

80% of all tests submitted

Final surgical pathology consultation report completion

Within 4 working days of specimen receipt for cases not requiring additional studies

80% of all consults submitted

CONTRACT PERFORMANCE MONITORING

D.1 - Attachment 1 - QASP

A. Monitoring of contractors performance shall be done by the Contracting Officer Representative (COR). Incidents of contract non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer. Upon award, a Quality Assurance Surveillance Plan will be signed by the Contract Program Manager and COR outlining the evaluation criteria to ensure the contractor is aware of the management and quality criteria required to meet the terms of the contract.

B. Frequency of Measurement: During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed. Annual reports are prepared by the COR and sent to the contractor by the CO 60-days prior to the contract option year renewal.

C. Frequency of Performance Assessment Meetings: The COR shall visit/correspond with the contractor wither on an as-needed basis or at a minimum, once during the contract:

1. Middle of contract; and

2. End of contract period to assess performance and shall provide written assessment. This written assessment will be forwarded to the Contracting Officer as documentation of contractors’ performance and/or for a request to exercise option period, renewal of a contract or termination of a contract.

D. Contractor will review annual performance measure reports and acknowledge receipt of report by returning a signed copy, along with any comments to the Contracting Officer within 30-days of receipt of report.