QASP.pdf

Quality Assurance Surveillance Plan (QASP)

Pharmacy Incubation and Speciation of Viable Samples for Compliance with USP 797 Sterile

Compounding Standards

Contract Number: TBD

Contract Description: An ISO/IEC 17025:2017 accredited laboratory under the Environmental

Microbiology Lab Accreditation Program (EMLAP) will process (incubate, analyze, record and report results) microbiological surface and air samples, Gloved Fingertip and Thumb (GFT) samples and Media Fill Testing (MFT) samples conducted and submitted by VA Medical Centers in Veterans Integrated Service Network (VISN) 21. Samples will be processed by the laboratory immediately upon receipt according to the general requirements outlined by ISO/IEC 17025:2017 and 2023 USP <797>.

Contractor’s name: ________________

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 Contracting Officer (CO):

• Assigned Contract Specialist:

• Organization: U.S. Department of Veterans Affairs

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.

Assigned COR(S):

c. Other Key Government Personnel:

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.

QUALITY ASSURANCE SURVEILLANCE PLAN

Pharmacy Services

No.

Paragraph in

SOW

Indicator/Performance Standard

Standard for Quality

Level

Acceptable Quality Level

Method of Surveillance1

Incentive/Disi ncentive

1 4.1 The Contractor shall incubate and process personnel related assessment GFT samples according to USP <797>. GFT results will be reported for each plate/paddle, with the amount of colony forming units (cfu) present on each plate reported. No growth present shall be indicated on the report as < 1 cfu. The Contractor shall notify the facilities listed of any issues that will/or did compromise sample results.

100% 98% Quarterly Customer survey

Positive past performance rating

Contractor prepares a corrective action plan if acceptable quality level is not reached.

2 4.2 The Contractor shall provide media-fill test kits as well as incubate and process personnel related assessment MFT samples according to

USP <797>. MFT

results will be reported as negative (pass) or positive (fail); failure is indicated by visible turbidity or other visual.

manifestations of growth in the media in one or

100% 98% Quarterly Customer survey

Positive past performance rating

Contractor prepares a corrective action plan if acceptable quality level is not reached.

1 See “Methods of Surveillance,” paragraph 6 of this QASP, for additional methods of monitoring performance.

more container–closure unit(s) on or before 14 days. The certificate of analysis (COA) for the media-fill test kits will be provided with the test results.

The Contractor shall notify the facilities listed of any issues that will/or did compromise sample results.

3 4.3 The Contractor shall incubate and process viable surface samples according to USP <797> standards. Surface sample results will be reported in number of cfu. If cfu measured during viable sampling exceed USP <797> action levels, the report will at a minimum identify genus and, when possible, species of any microorganism recovered on the report. No growth present shall be indicated on the report as 0 (zero) cfu or < 1 cfu. All samples will be processed as single media dual incubation as described in USP <797>. The Contractor shall notify the facilities listed of any issues that will/or did compromise sample results.

100% 98% Quarterly Customer Survey

Positive past performance rating

Contractor prepares a corrective action plan if acceptable

4 4.4 The Contractor shall incubate and process viable active air samples according to USP <797> standards. Active air sample results will be reported in number of cfu. If cfu measured during viable sampling exceed USP <797> action levels, the report will at a minimum identify genus and, when possible, species of any microorganism recovered on the report. No growth present shall be indicated on the report as 0 (zero) cfu or < 1 cfu. All samples will be processed as single media dual incubation as described in USP <797>. The Contractor shall notify the facilities listed of any issues that will/or did compromise sample results.

100% 98% Quarterly Customer survey

Positive past performance rating

Contractor prepares a corrective action plan if acceptable quality level is not reached.

5 4.5 The Contractor shall report the receipt of samples via email within two days of receipt. This report shall include the number of samples and their condition, and The Contractor shall provide a final report including sample identifications and results, incubation dates, incubation time period, incubation order and incubation temperatures for each sample.

The final report shall also contain the condition

100% 98% Quarterly Customer survey

Positive past performance rating

Contractor prepares a corrective action plan if acceptable of the sample at receipt, the type of media, the lot number, and the expiration date.

Reports will be made available digitally via email no later than 3 days after incubation of the samples.

5. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance.

a. Quarterly Customer Survey

6. 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:

See above Acceptable Quality Level & Method of Surveillance located in QASP.

7. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive OR NEGATIVE 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 work with the Contracting Officer (CO) 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. In order to assure that the contractor receives impartial, fair, and equitable treatment under this contract, the COR will work with the contractor to increase performance to an acceptable level.

When the COR and CO determines formal written communication is required, the COR and CO 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. The customer and the COR will determine the acceptability of the corrective action plan.

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

9. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.

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

b. Frequency of Performance Assessment Meetings.

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

Signature – Contractor

Signature – Contracting Officer Representative