QASP for Health Physics Consultation Services.pdf

QUALITY ASSURANCE SURVEILLANCE

PLAN (QASP)

HEALTH PHYSICS CONSULTATION SERVICES

#662-24-1-147-0005, #36C261-23-AP-5129

AUGUST 2024

662-SAN FRANCISCO VAMC

The Department of Veterans Affairs Sierra Pacific Network (VISN 21)

1. Objective: The contract requirement is to provide health physics consultation services for the Radiation Safety Protection Program of the SFVA Health Care System in San Francisco, in accordance with the Statement of Work (SOW). The Radiation Safety Protection Program oversees the use of radioactive material and machines producing ionizing radiation in research and clinical applications at Fort Miley and CBOCs. The Contractor will provide all labor, materials, tools, equipment, parts, transportation, etc., required to fulfill the requirements of the

SOW. Specifically, the Contractor’s primary responsibilities for providing consultation and advisory services for the Radiation Safety Program include providing professional knowledge and guidance, applying management expertise and skills, and supporting the Radiation Safety

Committee (RSC). This QASP has been developed to evaluate contractor actions while implementing the Performance-based SOW. It is designed to provide an effective surveillance method of monitoring contractor performance for each item listed under Description of Services in the SOW. The QASP provides a systematic method to evaluate the services and products the contractor is required to furnish. This QASP is based on the premise that the contractor, and not the government, is responsible for management and quality control actions to meet the terms of the contract. The role of the government quality assurance personnel is to ensure contract standards are achieved. Careful application of the process and standards presented in the remainder of this document will ensure a robust quality assurance program.

2. Government Roles and Responsibilities. The goals and responsibilities of the government are outlined below.

2.1. Contracting Officer (CO) Responsibilities: 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.

2.2. COR Responsibilities:

1. Ensures supplies or services rendered by Contractor meet contract requirements.

2. Notifies the CO and the Contractor of any performance deficiencies in writing or e-mail.

3. Assists with contract/order closeout.

4. Ensures discrepancy reports are accurate and reported properly.

5. Identifies areas that warrant a change in assessment method, frequency, or performance threshold and provides suggestions about the surveillance plan to the CO.

6. Maintains accurate documentation of Contractor assessment activities as required by the surveillance plan and reports the results of Contractor assessment activities to the CO.

7. Works with the Contractor and the CO to resolve issues.

8. Maintains files in accordance with the Surveillance Plan and requests CO disposition at the completion of the contract or termination of COR appointment (if applicable). Files include a copy of the contract/order and all modifications (unless readily available electronically); a copy of COR designation memorandum (if applicable); correspondence between you and the Contractor; copies of correspondence to or from CO; minutes of all meetings; copies of all invoices submitted and paid; and all other documentation of actions taken by COR.

9. Submits all requests for corrective action to the CO.

10. Inspects and accepts Contractor services at the completion of each contract payment period, usually monthly. The COR will certify services received, unless the CO retains the authority for acceptance.

3. Performance Assessment: The required performance objectives can be found in the

Consultation Services section in the SOW. The contractor service requirements are summarized into 3 performance objectives. The performance threshold describes the minimum acceptable levels of service for each requirement. The contractor shall be aware that the absence of any contract requirement from the service summary does not detract from its enforceability nor limit the rights or remedies of the Government under any other provision of the contract.

Method of Surveillance:

Performance Objective SOW

Para

Acceptable Quality

Levels

Surveillance Method

1. Professional Knowledge and Guidance:

Provide Health Physicist consultation and expertise to ensure compliance to regulations and respond to emergencies.

I 3(A) SATISFACTORY Periodic Monitoring and

Observation by the COR

2. Management Knowledge and Skills:

Review inspections and reports; audit records and work areas; and oversee Radiation Safety

Protection Program.

I 3(B)

SATISFACTORY Periodic Monitoring and

Observation by the COR

3. Radiation Safety Committee:

Support RSC and work with Chairperson to review reports and protocols and evaluate radiation safety issues.

I 3(C) SATISFACTORY Quarterly Review by the COR

SATISFACTORY

(Acceptable Quality Level):

Performance meets contractual requirements. The contractual performance may involve some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

Note: A Satisfactory rating has only minor problems, or major problems the contractor recovered from without impact to the contract. Also, there should have been NO significant weaknesses identified.

UNSATISFACTORY: Performance does not meet most contractual requirements, and recovery is not likely in a timely manner. The contractual performance being assessed contains serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

Note: An Unsatisfactory rating involves multiple significant events that the contractor had trouble overcoming and which impacted the GOVERNMENT.

4. Procedures: The government COR will periodically perform inspections to ensure

Contractor compliance with the appropriate paragraphs of the SOW and will record the results of inspections, noting the date and time. If inspection indicates a performance threshold is not met, the COR will notify the Contractor and the contracting officer of the deficiency for correction.

The Contractor shall be given a reasonable time after notification to correct the unacceptable performance if such correction is possible. The length of time allowed to correct the problem will depend upon the requirement and the deficiency, and the Contractor will be notified by the

CO of the time allowed for correction when the deficiency is reported to the Contractor. The

COR will not consider the services complete until all deficiencies have been rectified.

Deficiencies not corrected or estimated dates of completion that are not acceptable to the COR will be forwarded to the CO for action.

Performance of the contracted services will occur on site at a government facility at the

SFVAHCS, CBOC’s, and other VA facilities, such as the Research campus at Mission Bay.

The COR will certify services received under this contract in accordance with its terms and conditions, unless the CO retains authority for acceptance. Format is at the discretion of the

COR.

Upon notification from the contractor that the defect has been corrected, the COR will re-inspect the area/task associated with the deficiency. The COR will verify the root cause, and corrective/preventative actions submitted by the contractor will be identified to prevent reoccurrence.

4.1. Corrective Action Report (CAR): A CAR shall be used by the COR to document contract requirement findings and subsequent corrective actions to be taken. See attachment for template of CAR.

4.2. Definitions of Major Findings & Minor Findings. Major findings are contract non-conformances which are considered critical or major. IAW FAR 46.101, a major non-conformance means a non-conformance, other than critical, that is likely to result in failure or reduce the usability of the services for their intended purpose. A critical non conformance means a non-conformance that is likely to result in a hazardous or unsafe condition for individuals using, maintaining, or depending upon the services; or is likely to prevent performance of a vital agency mission. If, at any time, the COR identifies a condition as having a significant adverse effect on the quality of the activity, such as those stated below, the COR shall document their findings and notify the Contracting Officer immediately in writing (email is acceptable).

A. Contractor failure to meet a performance objective or threshold.

B. Failure to provide adequate corrective action to preclude reoccurrence of Government identified findings.

C. Failure to provide corrective action to deficiencies identified by the contractor within a prescribed suspense period.

D. Any failure to adhere to security and/or safety regulations that results in a security or safety incident.

A Minor Finding or a minor non-conformance (IAW FAR 46.101) means a non-conformance that is not likely to materially reduce the usability of the services for their intended purpose, or is a departure from established standards having little bearing on the effective use or operation of the services. When the COR identifies a minor finding, the COR shall document the findings, but is not required to notify the Contracting Officer. However, if the same minor finding is repeatedly identified, it may be an indication that a major finding is occurring, or has occurred, because the Contractor has not taken proper steps to prevent recurrence. In this case, the COR shall notify the Contracting Officer in writing (email is acceptable).

4.3. Methods of Surveillance: 1) Periodic Monitoring/Observation, and 2) Quarterly Review

4.3.1. Periodic Monitoring/Observation: Contractor performance will be monitored or observed as satisfactory or unsatisfactory.

4.3.2. Quarterly Review: Contractor performance in quarterly Radiation Safety Committee meetings will be reviewed as satisfactory or unsatisfactory.

4.4. Remedies for Non-Conformance. If mode of surveillance indicates unsatisfactory performance, the COR will notify the Contractor of the deficiencies for correction. The

Contractor shall be given an appropriate time frame (depending on the discrepancy identified) after notification to correct the unsatisfactory or unacceptable performance. If deficiencies are not corrected within the required time frame, the COR should notify the CO for action. If the

Contractor disagrees with the noted discrepancy, and an agreement cannot be reached, the CO shall be notified for a final decision.

5. Revisions to this Surveillance Plan. Revisions are the joint responsibility of the CO and

COR. This document can be changed at any time.

COR NAME: Stephen Fong, COR II TITLE: Associate Radiation Safety Officer

SIGNED:

Corrective Action Report (CAR) Template - Feb 05 Revised.doc