36C25619Q0403-004.pdf

36C25619Q0403 Attachment 3

Quality Assurance Surveillance Plan (QASP)

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): Le Kisha A. Douglas

• Organization or Agency: Department of Veterans Affairs, Network Contracting Office (NCO) 16

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): Richard L. Morris, 501-257-2934

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.

QASP

Preventive Maintenance

Number Paragraph in PWS

Indicator/Performance Standard

Standard for

Quality Level

Acceptable Quality Level

Method of Surveillance0F

Incentive

1 3 The Contractor and technicians shall continuously maintain a) CETA CNBT accredited Registered Cleanroom Professional Certification for Sterile Compounding Facilities; b) NSF accredited Biosafety Cabinet Field Certification throughout life of the contract.

100% 100% Periodic Inspection

Positive Past Performance Rating

2 4.1 The contractor shall perform facility-related testing and sampling according to the most current version of CAG- 003-2006 and CAG-009- 2011v3 to determine whether the cleanroom, LAFW, and BSC within the sterile compounding facility can be certified for use under USP 797.

100% 100% Periodic Inspection

Positive Past Performance Rating

3 4.2 The contractor shall perform personnel-related assessments and testing according to the most current version of CAG- 009-2011v3 to ensure that sterile compounding personnel are properly trained to aseptically compound hazardous and non-hazardous sterile compounded products within the sterile compounding facility under

USP 797.

100% 100% Periodic Inspection

Positive Past Performance Rating

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

4 6a The contractor shall coordinate a schedule with the COR to provide all applicable services at required intervals.

100% 100% Progress or Status Meetings

Positive Past Performance Rating

5 6b The contractor shall provide to the COR a certificate for each cleanroom, LAFW, and BSC that is certified before leaving the facility. Any cleanroom, LAFW, or BSC that is not certifiable shall be brought to the attention of the COR by the contractor before leaving the facility. In addition, the cleanroom, LAFW, or BSC in question will be marked as such with clear signage that the unit is out of service until further notice

100% 100% Direct Observation

Positive Past Performance Rating

6 6c The contractor shall ensure the COR signs the personnel assessment prior to departing the facility

100% 100% Direct Observation

Positive Past Performance Rating

7 6d The contractor shall contact the COR upon completion of work to verbally report any sampling issues before the contractor leaves the facility. Larger formal reports as required for the pharmacy clean rooms that include viable sampling and environmental sampling kits for hazardous drug detection shall be submitted to the COR within fifteen (15) business days following the collection of the viable sampling and /or surface sampling kit. Results of viable samples and/or surface sampling kit shall be submitted to the COR within one (1) business day

100% 100% Periodic Inspection

Positive Past of the receipt of the results from a properly accredited laboratory. All microbiological samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Environmental Microbiology Lab Accreditation Program (EMLAP). All environmental wipe samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Industrial Hygiene Laboratory Accreditation Program (IHLAP)

8 6f The contractor shall procure and maintain for the entire contract period, Workmen's Compensation and employer's general liability Insurance

100% 100% Periodic Inspection

Positive Past Performance Rating

9 6k The contractor shall submit invoices accurately and timely for all services billed

100% 100% Periodic Inspection

Positive Past

5. INCENTIVES/RATING STANDARDS

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

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance.

a. DIRECT OBSERVATION

b. PERIODIC INSPECTION

c. USER SURVEY

d. VALIDATED USER/CUSTOMER COMPLAINTS

e. INSPECTION

f. PERIODIC SAMPLING

g. RANDOM SAMPLING

h. PROGRESS OR STATUS MEETINGS

i. ANALYSIS OF CONTRACTOR’S PROGRESS REPORTS

7. 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:

8. 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. 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 must 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.

9. 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.

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

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

Contractor

Richard L. Morris Contracting Officer Representative

Various methods exist to monitor performance.