36C25620Q0528-003.pdf

Quality Assurance Surveillance Plan (QASP)

Research and Clinical Annual Certification and Maintenance Services

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.

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.

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

# PWS

Paragraph

Indicator/Performance Standard

Standard for

Quality Level

Acceptable Quality Level

Method of Surveillance

Incentive

1 1.1 The Contractor shall furnish all labor, materials, parts, equipment, tools, transportation, travel, licensed/certified personnel, management, and supervision required to perform annual inspection and certification of the Michael E. DeBakey VA Medical Center’s (MEDVAMC) Biological Safety Cabinets (BSC), Chemical Fume Hoods (CFH), Grossing Stations, and Canopy Hoods. The contractor shall also perform Alarm Recalibration on all certified equipment.

100% 100% Periodic Inspection

Positive Past Performance

Rating

2 3.2 The Contractor shall furnish and replace parts to meet SOW requirements. The Contractor shall provide new or factory reconditioned OEM parts and components when providing maintenance and repair services as described.

100% 100% Periodic Inspection

Positive Past Performance

Rating

3 4 The Contractor shall perform Annual Inspection and Certification services as outlined in paragraph 4 of the PWS.

100% 100% Periodic Inspection

Positive Past Performance

Rating 4 5 The Contractor shall perform the requirements outlined in paragraph 5 of the PWS.

100% 100% Periodic

Inspection Positive Past Performance

Rating

5 6 The Contractor shall ensure all qualifications outlined in Paragraph 6 are adhered to.

100% 100% Periodic Inspection

Positive Past Performance

Rating

6 9 The Contractor shall ensure its employees conducting certifications are appropriately trained and certified to standards outlined in Paragraph 9 of the PWS.

100% 100% Periodic Inspection

Positive Past Performance

Rating

7 17.2 The contractor shall submit requests for payment electronically to the VA’s Tungsten Network.

Invoices shall be paid Quarterly in arrears for all authorized work performed upon receipt of a properly prepared invoice. Invoices must include contract number, purchase order number, location inspected/treated, and date inspected/treated. Non-performance or late performance may result in delayed or reduced payment under this contract.

100% 100% Periodic Inspection

Positive Past Performance

Rating

5. INCENTIVES/RATING STANDARDS

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

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

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

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

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

Contractor

Various methods exist to monitor performance.