P11 QASP CARDIAC EVENT MONITORING.docx

?.## QUALITY ASSURANCE SURVEILLANCE PLAN

For: Medical Services

Contract Number: < Upon award, Government will enter contract number>

Contract Description: CARDIAC EVENT MONITORING

Contractor’s name: Upon award, Government will enter

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 CO: <Upon award, Government will enter name.> Organization or Agency: Department of Veterans Affairs, Office of Acquisition and Materiel Management

b. Contracting Officer’s Technical 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: <Upon award, Government will enter name.>

c. Other Key Government Personnel - <Upon award, Government will enter name, if applicable. This may include Performance Monitors, Clinical Quality experts, etc. who act on behalf of the COR to monitor performance.>

3. CONTRACTOR REPRESENTATIVES

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

a. Program Manager – Jessica Ihnen COR

b. Other Contractor Personnel – William Pochis, MD – Cardiology Supervisor; Paul Phelps – Vascular Technician; Michael Ricks – Vascular Technician

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, paragraph 4, in the Performance Work Statement (PWS), includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Task

Access- Customer

Access-System dependability

Record review Continued contract performance

Timeliness-Reports

Notified by staff that physician did not respond to department in a timely manner Continued contract performance

Patient Satisfaction

5. INCENTIVES

The Government shall use continued contract performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

1, 2, 3, 4, 5, 6

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

1, 2, 3, 4

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

1, 2, 3, 4

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.)

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

e. 100% INSPECTION. (Evaluates all outcomes.)

1,2,3,4

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.)

1, 2, 3

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

1, 2, 3

h. Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)

8. 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:

Observation and random inspection (auditing). User survey, observation, investigation.

9. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall 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 shall 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.

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

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

10. 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 contact/meet with the contractor at least monthly to assess performance and shall provide a written assessment.

<After award, both the contractor’s Program Manager and the COR shall sign this document.>

Signature – Contractor Program Manager

Signature – Contracting Officer’s Representative