2021 Radiopharmaceutical Quality Assurance Surveillance Plan.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN

(QASP)

For: Radiopharmaceutical Services

Contract Number: Upon award, Government will enter contract number

Contract Description: Provide a brief contract description of services provided

Contractor’s name: Enter company name

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.

*Note. The QASP is not a part of the contract. Its sole use is to monitor contractor performance.

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:

Organization or Agency: Department of Veterans Affairs, VA Sierra Pacific Network (VISN 21)

<Instruction boxes look like this.>

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: Sandra Kosinski

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 - Enter name, if any

b. Other Contractor Personnel - Enter name(s) of the providers.

4. PERFORMANCE MEASURES

Performance measures are comprised of performance indicators (some characteristic of a deliverable that can be measured) and performance measures (a mark, measure or benchmark that government personnel use as a point of comparison when evaluating contractor performance). The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these measures.

The Performance Requirements Summary Matrix, paragraph <enter number> in the Performance Work Statement (PWS), includes performance measures. The Government shall use these measures to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Task ID

PERFORMANCE

Indicator

MEASURES

Standard

Acceptable Quality Level

Method of Surveillance

Score 90, 95, or 100%

Q1 Q2 Q3 Q4

Schedule Delivery Compliance

Scheduled delivery.

Percentage vendor cannot make delivery.

100% Observation and random inspection

Product

Accuracy of requested product

Percentage vendor correctly delivered.

95% Observation

Billing 3 Accuracy of monthly billing

Percentage vendor correctly billed

100% Observation

5. INCENTIVES AND DISINCENTIVES

There are no incentives or disincentives. The Government shall use the scoring methods above for continuing contract performance.

6. METHODS OF QUALITY ASSURANCE SURVEILLANCE

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

a. DIRECT OBSERVATION: The COR can perform periodically or through 100% surveillance.

b. PERIODIC INSPECTION. The COR evaluates outcomes on a periodic basis. Inspections may be scheduled daily, weekly, monthly, quarterly, or annually or use unscheduled inspections.

c. USER SURVEY: This method combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction. The COR may also generate inspections and sampling.

d. VALIDATED USER/CUSTOMER COMPLAINTS. This method relies on the patient to identify deficiencies. Complaints are then investigated and validated.

e.100% INSPECTION. The COR may evaluate all outcomes.

f. RANDOM SAMPLING. This is designed to evaluate performance by randomly selecting and inspecting a sample of cases.

g. Progress reports or status meetings. The COR will analyze contractor's progress reports.

(Evaluate cost, schedule, etc.)

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: 100% is positive, 95% is neutral, and 90% is negative.

8. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE (100% RATING)

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE (90% RATING)

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 and a copy to the Contracting Officer.

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