3. D.3 QASP.pdf

Quality Assurance Surveillance Plan (QASP)

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.

Assigned CO: Andrew Schoenecker, andrew.schoenecker@va.gov 651-293-3035

Organization or Agency: Network-23 Contracting Officer (NCO-23)

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 CORs: Shanna Vagts, Assistant Administrative Officer/COR Lynda Dent, Administrative Officer/COR Jeffrey Fuqua, Program Specialist/COR

Organization or Agency: Minneapolis VA Health Care System

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. For this service, 100% surveillance will not be performed by the COR.

b. PERIODIC INSPECTION. Quarterly periodic inspections will be completed by the Service Chief or designee and reported to the COR. Physical presence is checked on a monthly basis by the COR checking with the using service to see if provider is present in the medical center and providing the services as required by the contract.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Discussion with individuals involved in patient care and who are familiar with the provider’s work, will be randomly polled quarterly or as needed by the COR.

d. RANDOM SAMPLING. Patient charts will be randomly sampled semi-annually by the Service Chief or designee reviewing up to ten (10) randomly selected CPRS records to verify required documentation. (All reviews and reports will be conducted in compliance with VA Privacy and Information security standards).

e. Verification and/or documentation provided by contractor. COR will work with the Medical Staff Office to verify maintenance of valid license and other credentialing requirements; documentation to be verified annually.

6. QASP PERFORMANCE REPORT DATE: __________________

Measures PWS Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

Met AQL/DID NOT MEET

AQL-

CPAR RATING/ADD

COMMENTS

1 – Qualifications of Key Personnel

4.7.1. The Medical Physicists

provided must meet qualifications requirements and must be present at VA and providing required services in compliance with the standard of care as specified in the contract

PWS.

Qualified personnel are on-site and in location as needed to properly perform required tasks per contract PWS.

100% Random Inspection of qualification documents

2-Time and Attendance 4.7.2. The contractor shall provide contractor’s Medical Physicists are in accordance with the operating hours and VA clinical schedule outlined in this PWS.

All (100%) contractor’s Medical Physicists are on time and available to perform services.

Contractor’s physicians on-time and available to perform services 100% of the time.

Periodic Sampling of Time and Attendance Sheets

3 - Mandatory Training 4.7.3. Contractor shall complete all required training on time per VAMC policy.

All (100%) of required training is complete on time by contractor’s Medical Physicists.

100% completions

Periodic Sampling

4 - Privacy, Confidentiality and

HIPPA

4.7.4. Contract provider(s) shall

comply with all privacy, confidentiality and HIPAA laws, regulations, policies and procedures.

All (100%) contractor provider(s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and

HIPAA

100% Periodic Sampling;

Contractor shall provide evidence of annual training required by VAMC, reports violations per VA Directive 6500.6.

5- Standard Operating Procedures (SOP) documented for all radiotherapy techniques

4.7.5.

Policy and Procedure for every treatment methodology documented per applicable guidelines.

All (100%) of radiotherapy techniques employed by the contractor, such as Conventional

No deviations from the standard (100%).

Random inspection of procedure documentation and medical records submitted in accordance

External Beam, IMRT, IGRT, SBRT, SRS, Brachytherapy, etc., have written procedures in accordance with ACR guidelines.

All (100%) of procedures are reviewed and updated annually.

with facility reporting requirements.

6 - Quality Assurance/Quality Improvement (QA/QI) Documentation

4.7.6.

The contractor shall have an operational performance improvement process in accordance with ACR Standards; including data collection, measurement, assessment and improvement. Data shall be required on processes, outcomes, patient satisfaction, and quality control. Appropriate statistical quality control techniques in compliance with ACR standards must be utilized. Results of performance improvement activities must be reported quarterly to the VA Radiation Oncology Service Quality Assurance Committee.

100% of QA/QI documents complete in accordance with ACR standards and reported as required to VA Radiation Oncology Service QA Committee.

Almost all (90%) of QA/QI documents complete in accordance with ACR standards and reported as required to the VA Radiation Oncology Service QA Committee.

Periodic Inspection of QA/QI documents provided.

7 - Radiation Safety Policy and Standards for ACR Accreditation

4.7.7. CTMP is responsible for the

Radiation Safety Program (RSP) of the Radiation Oncology Service/Section.

The RSP shall meet the accreditation standards of the ACR Radiation Oncology Program for Accreditation (ROPA). RSP shall meet the radiation safety standards, policies and procedures set by NRC, NHPP and the ACR. The RSP status, to

All (100%) Radiation safety standards and external review requirements shall be met. Quality Management reports shall be submitted quarterly to the Minneapolis VAHCS Radiation Safety Committee.

100% Periodic Inspection include the correction plan for all radiation safety related deficiencies noted by site surveys from ACR, NHPP or Imaging and Radiation Oncology Core (IROC) shall be reported quarterly as a part of the quarterly medical physicist report to the Minneapolis VAHCS Radiation Safety Committee.

8 - Medical Physicist Reports demonstrate ACR Standards

4.7.8. Contractor’s Medical

Physicists 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.

All (95%) 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.

95% Periodic Inspection of Documents

7. CPAR RATINGS ASSIGNED TO QASP ITEMS:

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used (Reference: CPARS User Manual https://www.cpars.gov/pdfs/CPARS-Guidance.pdf p. A2-1):

EXCEPTIONAL: Performance meets contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

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.

VERY GOOD:

Performance meets contractual requirements and exceeds some to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

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.

SATISFACTORY:

Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

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.

MARGINAL:

Performance does not meet some contractual requirements. The contractual performance of the element or sub-element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor’s proposed actions appear only marginally effective or were not fully implemented.

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).

UNSATISFACTORY:

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

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).

https://www.cpars.gov/pdfs/CPARS-Guidance.pdf

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 determines formal written communication is required, the COR shall prepare a Contract Report (CR), and present it to CO. The CO will in turn review and will present to the contractor's program manager for corrective action.

The contractor shall acknowledge receipt of the CR in writing. The CR 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 CR 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.

Any CRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO. See Sample CR on the following page.

9. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

CONTRACT REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS DISCREPANCY

3. TO: (Contracting Officer) 4. FROM: (Name of COR)

5. DATES

a. CR PREPARED

b. RETURNED BY

CONTRACTOR:

c. ACTION COMPLETE

6. Issue Identified (Describe in detail. Include reference to PWS Directive; attach continuation sheet if necessary.)

7. SIGNATURE OF COR Date:

8. SIGNATURE OF CONTRACTING OFFICER Date:

9a. TO (Contracting Officer) 9a. FROM (Contractor)

10. CONTRACTOR RESPONSE AS TO CAUSE AND ACTIONS TO PREVENT RECURRENCE.

(Cite applicable quality control program procedures or new procedures. Attach continuation sheet(s) if necessary.)

11. SIGNATURE OF CONTRACTOR REPRESENTATIVE Date:

12. GOVERNMENT EVALUATION.

13. GOVERNMENT ACTIONS

14. CLOSE OUT

NAME TITLE SIGNATURE DATE

CONTRACTOR

NOTIFIED

COR

CONTRACTING

OFFICER