ATTACHMENT 5 - QUALITY ASSURANCE SURVEILLANCE PLAN.docx

ATTACHMENT 5 – QUALITY ASSURANCE SURVEILLANCE PLAN

36C25619Q1195

QUALITY ASSURANCE SURVEILLANCE PLAN

For: Pharmacy Hazardous Drug Compounding Services

Contract Number: TBD

Contract Description: Compounding of Hazardous drugs for Chemotherapy treatments

Contractor’s name: TBD

Period of Performance: October 1, 20204 through September 30, 2025 (Base plus four option periods. Options to be exercised at the Government’s discretion)

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: Beth Cook Organization or Agency: Department of Veterans Affairs, Network Contract Office 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: Joni Groat

c. Other Key Government Personnel – Elizabeth Beatty

3. CONTRACTOR REPRESENTATIVES

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

a. Program Manager – TBD

b. Other Contractor Personnel – TBD

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.

Performance Requirements Summary Matrix:

The Government will use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Rating

Positive Past Performance & Exercise of Option Period

5. INCENTIVES

The Government shall use Exercise of Option Period and Past 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.

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

Performance Standard(s) ID: 2, 3

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

Performance Standard (s) ID: 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.)

Performance Standard(s) ID: N/A

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

Performance Standard(s) ID: 1,2

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

Performance Standard(s) ID: 1

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.)

Performance Standard(s) ID: N/A

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

Performance Standard(s) ID: N/A

h. Progress or status meetings.

Performance Standard(s) ID: N/A

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

Performance Standard(s) ID: 1,2

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:

Excellent (“E”) = Exceeds Standards Satisfactory (“S”) = Meets Standards Unsatisfactory (“U”) = Fails To Meet Standards

8. 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.

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 quarterly to assess performance and shall provide a written assessment.

Signature Contracting Officer’s Representative

Contract Discrepancy Report

Contractor/Manager’s Name:

From: (Name of Project Officer)

Dates

Prepared:

Returned by Contractor:

Action Complete:

Discrepancy or Problem:

Signature of Contracting Officer:

To: (Contracting Officer)

From: (Contractor)

Contractor Response as to Cause, Corrective Action and Actions to Prevent Recurrence (Attach Continuation Sheet if Necessary)

Signature of Contractor Representative:

Date:

Government Evaluation:

Government Actions:

Close Out

Contractor Notified

Project Officer

Contracting Officer