Quality Assurance Surveillance Plan (QASP).doc

Quality Assurance Surveillance Plan (QASP) For: Biomedical Engineering Contract Number: To Be Determined Contract Description: Annual Compliance Testing of Diagnostic Radiological Equipment (Imaging Modalities) Contractor’s Name: To Be Determined

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 will 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 will 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: C. Robert Oravetz Organization or Agency: Department of Veterans Affairs, Network Contracting Office 16, Biloxi, MS

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and will assure proper Government surveillance of the contractor’s performance. The COR will 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: To Be Determined

c. Other Key Government Personnel – N/A

3. Contractor Representatives The following employees of the contractor serve as the contractor’s program manager for this contract.

a. Program Manager – To Be Determined

b. Other Contractor Personnel – To Be Determined Title: To Be Determined

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 in the Performance Work Statement (PWS), includes performance standards. The Government will use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Ref. SOW Sections 1 – 1.1, 3,8, Table A

Ref. SOW Section 1: 4-6

SOW: Section 3

5. Incentives The Government will use Exercise of Option Period (if applicable) and Past Performance as incentives. Incentives will be based on exceeding, meeting, or not meeting performance standards.

6. Methods of Surveillance* Various methods exist to monitor performance. The COR will use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

Performance Standard(s): 1, 2, 3, & 6

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

N/A

c. USER SURVEY. (Combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction. May also generate inspections and sampling.)

N/A

d. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.) N/A

e. 100% INSPECTION. Pertains to review of documents or credentials for vetting purposes to ensure qualifications have been or are being met. ID#: 5

f. 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.)

N/A

g. RANDOM SAMPLING. (Designed to evaluate performance by randomly selecting and inspecting a sample of cases.

N/A

h. Progress or status meetings.

N/A

i. Analysis of contractor's progress reports. (Evaluate cost, schedule, maintenance documentation, etc.)

Performance Standard(s) ID #: 1, 2, 3, 4, & 6.

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 will be used to determine a positive, neutral, or negative outcome. The following ratings shall be used: Excellent = Exceeds Standards, Satisfactory = Meets Standards, Unsatisfactory = Fails To Meet Standards

8. DOCUMENTING PERFORMANCE

a. Acceptable Performance The Government will 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 will inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR will document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR will 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.

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 will meet with the contractor quarterly via telephone (if necessary, i.e. if any problems exist) to assess performance and shall provide a written quarterly assessment.

Signature – Contractor Program Manager

Signature – Contracting Officer’s Representative