36C260-18-Q-0301-042.docx

Attachment B 36C260-18-Q-0301 Quality Assurance Surveillance Plan

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

for Therapeutic Medical Physicist

The contractor will be evaluated in accordance with the following:

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 through contract modification. 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.

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

3. CONTRACTOR REPRESENTATIVES

The following employee(s) of the contractor serve as the contractor’s program manager(s) for this contract:

Primary: ______________________________

Alternate: ______________________________

4. PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs will provide contract progress reports quarterly to the CO reflecting performance on this plan and all other aspects of the resultant contract. The performance standards outlined in this QASP shall be used to determine the level of contractor performance in the elements defined. Performance standards define desired services. The Government performs surveillance to determine the level of Contractor performance to these standards.

The Performance Requirements are listed below in Section 6. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the standard and assign a rating. At the end of the performance period, these ratings will be used, in part, to establish the past performance of the contractor on the contract.

5. 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. 90% surveillance by Director of Radiation Oncology

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. The Director of Radiation Oncology will review 10 randomly selected patient files per inspection period. All inspections and reports will be conducted in compliance with VA Privacy and Information Security standards.

c. RANDOM SAMPLING. The Director of Radiation Oncology will review 10 randomly selected patient files per quarter. All reviews and reports will be conducted in compliance with VA Privacy and Information Security standards.

d. CONTRACTOR SUBMITTALS. Contract Therapeutic Medical Physicist submits.

6. PERFORMANCE MEASURES

Acceptable Quality Level

Surveillance Method

1. Qualifications and Certification

2.1 4.6.1

Radiation Oncology Therapeutic Medical Physicist provided in compliance within standard of care outlined in this PWS. Radiation Oncology Physicist shall be board certified in accordance with ACR Standards and that treatment is provided in compliance within standard of care outlined in this PWS.

2. Chart Review/Physics Check/Consults

4.4.2.4 4.4.2.5 4.4.2.6 4.4.2.8 4.6.2

All notes must be electronically signed and all encounters closed within 24 hours.

Consolations as needed.

Surveillance Method

3. Standard Operating Procedures (SOP) documented for all radiotherapy techniques.

4.4.1.9 4.6.3 Policy and Procedure for every treatment methodology documented per applicable guidelines

100% of Radiation Oncology Physicists shall be board certified in accordance with ACR Standards and available to provide the required scheduled services to veterans 100% of the time

4. Quality Assurance/Quality Improvement (QA/QI) Documentation

4.4.1.3 4.4.2.5 4.4.2.5 4.4.2.14 4.6.4

5. ACR Radiation Safety Standards / Patient Safety / Radiation Safety

4.2 4.4.1.2 4.5.2 4.6.5

NRC/NHPP Radiation safety standards, policies and procedures, including the NRC Quality Management Program rule, shall be met and be reported quarterly as a part of the quarterly medical physicist report. Patient Safety incidents, including medical events involving radioactive material and misadministration, must be reported

Surveillance Method

6. Medical Physicist Reports demonstrate ACR Standards

4.4.2.5 4.4.2.9 4.4.2.14.11 4.4.2.14.12 4.6.6

Contractor’s Medical Physicist shall develop and maintain a quality management program (QMP) for the dosimetry system(s) and all applications pertinent thereto. Said QMP shall define explicit evaluation criteria intended to ensure that the prescribed dose is delivered in a safe, consistent and accurate manner. Contractor shall provide the VA Radiation Oncology Service, with written reports of these activities. Quality management of radiation therapy equipment is primarily an ongoing evaluation of functional performance characteristics. Patient safety incidents, including medical events involving radioactive material and misadministration, must be reported.

100% of required medical physicist reports documenting the successful evaluation of equipment performance (meeting or exceeding ACR Standards) to include therapy machines, radiation sources, and simulators for proper working order is required. All external review requirements per ACR Standards are met, including those of TJC

7. Mandatory Training

Contractor personnel will assure that all required training is up to date at all times

8. Policy and Regulations

Privacy, Information Security and HIPAA

9. Professionalism/ Conduct

Zero complaints from VA Medical Center staff members related to the contractor’s employee interfering with patient care or the ordinary operation of the facility

7. RATINGS

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used:

Note: To justify an Exceptional rating, you should identify multiple significant events in each category and state how it was a benefit to the GOVERNMENT. However, a singular event could be of such magnitude that it alone constitutes an Exceptional rating. Also, there should have been NO significant weaknesses identified.

Note: To justify a Very Good rating, you should identify a significant event in each category and state how it was a benefit to the GOVERNMENT. Also, there should have been NO significant weaknesses identified.

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

Note: To justify Marginal performance, you should identify a significant event in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. A Marginal rating should be supported by referencing the management tool that notified the contractor of the contractual deficiency (e.g. Management, Quality, Safety or Environmental Deficiency Report or letter).

Note: To justify an Unsatisfactory rating, you should identify multiple significant events in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. However, a singular problem could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An Unsatisfactory rating should be supported by referencing the management tools used to notify the contractor of the contractual deficiencies (e.g. Management, Quality, Safety or Environmental Deficiency Reports, or letters).

8. DOCUMENTING PERFORMANCE

a. The Government shall document positive and/or negative performance. Any report may become a part of the supporting documentation for any contractual action and preparing annual past performance using CONTRACTOR PERFORMANCE ASSESSMENT REPORT (CPAR).

b. If contractor performance does not meet the Acceptable Quality Level, the CO shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case, the CO shall document the discussion and place it in the contract file. When the COR and the CO determine formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR) and present it to the CO. The CO will, in turn, review and present to the contractor’s program manager for corrective action.

c. 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 CO. The Government shall review the contractor’s corrective action plan to determine acceptability. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance and the acceptability of the contractor’s corrective action plan.

d. Any CDR 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

The frequency of measurement is defined in the contract or otherwise in this document. The Government (CO or COR) will periodically analyze whether the frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Reporting

The COR shall communicate with the contractor and will provide written reports to the CO quarterly (or as outlined in the contract or COR delegation) to review contractor performance.

10. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

Program Manager [Firm Name]

Program Manager/FAC-COR II Dept. of Veterans Affairs