D.1 Quality Assurance Surveillance Program QASP.pdf

Quality Assurance Surveillance Plan (QASP) 36C25524R0061

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 will monitoring take place?

• Who will conduct the monitoring?

• How will monitoring efforts and results 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: Mike Carson, 913-946-1119, michael.carson1@va.gov.

Organization or Agency: Network Contracting Office (NCO) 15

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: Kristen Turner, 314-652-4100 x56350, kristen.turner6@va.gov Organization or Agency: Diagnostic Imaging Service, VA St. Louis Healthcare System

(VASTLHCS).

3. CONTRACTOR REPRESENTATIVES

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

Primary Program Manager:

Alternate Program Manager:

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. 100% surveillance: COR will make quarterly spot-checks as to the staff performance.

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. Ten (10) randomly selected patient files will be reviewed per year. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Customer complaints will be monitored by the COR and discussed generally at the weekly staff meeting, and specifically if needed with the staff member.

d. RANDOM SAMPLING. Five (5) randomly selected patient files will be reviewed per quarter. All reviews and reports will be conducted in compliance with VA Privacy and Information security standards.)

e. VERIFICATION AND/OR DOCUMENTATION PROVIDED BY CONTRACTOR. All documentation will be verified by the COR.

6. SAMPLE QASP PERFORMANCE Report DATE: ____________

Measure

PWS

Para.

Performance Requirement

Standard Acceptable

Quality Level

Surveillance Method

Met AQL/DID NOT MEET

AQL-

CPARS RATING/ADD

COMMENTS

Provider Quality

4.6.4.1 Per TJC standards, ongoing

professional practice evaluation information is factored into the decision to maintain existing privilege(s), to revise existing privilege(s), or to revoke an existing privilege prior to or at the time of renewal.

OPPE documentation for all (100%) staff providing services under the contract. All staff (100%) meet Standards.

100% meet relevant radiotherapy practice standards

Ongoing Provider Performance Evaluation (OPPE) data pertinent to Radiation Therapy care performed for each provider working under this contract.

The Contractor shall furnish OPPE data on new providers added to the contract at three months, six months and semi-annual thereafter. The OPPE data shall be provided to the COR. OPPE data should include the following elements:

A. Patient Care Performance

B. Medical/Clinical knowledge

C. Practiced Based Learning and Improvement

D. Interpersonal and Communica Skills

E. Professionalism

F. System Based Practice

Qualifications and Availability of Key Personnel

4.6.4.2 Radiation Oncology Physicians

shall be board certified and in accordance with national recognized accrediting body standards; Therapeutic Radiologic Therapists shall be registered & certified through the American Registry of Radiologic Technologists. The Contractor shall provide evidence that workload is distributed between 2 or more providers within the group and that treatment is provided in compliance within standard of care outlined in this PWS.

All (100%) of Radiation Oncology Physicians, Therapeutic Medical Physicists, Dosimetrists shall be board certified and in accordance with national recognized accrediting body standards;

Therapeutic Radiologic Therapists shall be registered & certified through the American Registry of Radiologic Technologists, and available to provide the required scheduled services to veterans 100% of the time.

No deviations from the standard (100%).

Periodic Sampling of qualification documentation and medical records submitted in accordance with contractor reporting requirements

Quality Assurance/

Quality Improvement

(QA/QI)

Documentation

4.6.4.3 The contactor shall have an

operation performance improvement process in accordance with practice guidelines and standards promulgated by ACR, ASTRO, and AAPM; 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 relevant radiotherapy practice standards must be utilized.

Results of performance improvement activities must be reported quarterly to the VA Radiation Oncology Service Quality Assurance Committee.

Reviewable records of device quality assurance shall be maintained. Daily, monthly and annual QA documentation for linear accelerators and CT Sim are accessible.

100% of QA/QI documents complete in accordance with

ACR. ASTRO &

AAPM standards and reported as required to VA Radiation Oncology Service QA Committee. 100% of QA/QI documents complete in accordance with appropriate radiotherapy practice standards and reported as required to Tumor Board.

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.

Radiation Safety Policy and Standards for Practice Accreditation Performance Requirement

4.6.4.4 CTMP is responsible for the

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

RSP shall meet the radiation safety standards, policies and procedures set by NRC, NHPP and the relevant radiotherapy practice accreditation. The RSP status, to include the correction plan for all radiation safety related deficiencies noted by site surveys from relevant radiotherapy practice accreditation. NHPP or Imaging and Radiation Oncology Core (IROC) shall be reported quarterly as a part of the quarterly medical physicist report to the Facility’s Radiation Safety Committee.

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

100% Periodic Inspection

Patient Access 4.6.4.5 The Contractor shall provide Contractor’s physician(s) in accordance with the operating hours and VA clinical schedule outlined in this PWS.

All (100%) Contractor’s physicians are on time and available to perform services

Contractor’s physician(s) are on time and available to perform services 100% of the time

Periodic Inspection of Time and Attendance Sheets

Patient Safety/Radiation Safety

4.6.4.6 Patient safety incidents, including medical events involving radioactive material and mis-administrations, must be reported.

Chart Review/Physics Check/Consults are completed weekly

100% RIRAS/JPSR reports are pulled quarterly. M&M reports are reviewed and followed quarterly for trends.

Maintains licensing, registration, and certifications

4.6.4.7 Updated Licensing, registration and certifications will be provided as they are renewed.

100% Licensing registration information kept current.

100%

Random Sampling and Periodic Inspection

Mandatory Training 4.6.4.8 Contractor completes all mandatory required training

All Training (100%) completed as required per VAMC policy

100% Contractor to provide documented evidence

Privacy, Confidentiality and HIPAA

4.6.4.9

Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPPA and complies with all standards

Zero breaches of privacy or confidentiality

100%

Contractor to provide evidence of annual training required by VAMC, reports violations per policy.

Professionalism/ Conduct

4.6.4.10 Contractor employees

maintain excellent relationships with patients, Radiation Oncology staff members, VA Medical Center staff members, and vendors.

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.

100% COR notification of complaints

Standard Operating Procedures

(SOP)

documented for all radiotherapy techniques

4.6.4.11 Policy and Procedure for every

treatment methodology documented per applicable guidelines.

All (100%) of radiotherapy techniques employed by the Contractor, such as Conventional External Beam, IMRT, IGRT, SBRT, SRS, Brachytherapy (edit per the PWS and services available), etc., have written procedures in accordance with radiotherapy practice standards. All (100%) of procedures are reviewed and updated annually.

90% Random Sampling of procedure documentation and medical records submitted in accordance with facility reporting requirements.

Patient Reports and Documentation

4.6.4.12 All notes must be electronically signed, and all encounters closed within 24 hrs.

Compliance with VA Rules and Regulations 95% Random Sampling and

Periodic Inspection

Peer Review Conferences/Ch art Rounds

4.6.4.13 Conduct Weekly Peer Review Conferences/Chart Rounds as required by the PWS.

Peer Review Conferences/Chart Rounds conducted, documented, and reported as required.

90%

Periodic Inspection and verification and/or documentation provided by contractor

7. CPARS 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/documents/CPARS-Guidance)

EXCEPTIONAL: Contractor always meets the standard. 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: Contractor almost always meets the standard, always performs over the Acceptable Quality Level. 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: Contractor occasionally meets the standard, but more often meets the Acceptable Quality Level. 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: Contractor most often meets the Acceptable Quality Level, occasionally does not meet the Acceptable Quality Level and CDRs have been reported.

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 https://www.cpars.gov/documents/CPARS-Guidance deficiency (e.g., Management, Quality, Safety or Environmental Deficiency Report or letter).

UNSATISFACTORY: Contractor has history of not meeting Acceptable Quality Level. Significant efforts have been made to bring Contractor into performance. 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).

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

REPORTING SYSTEM (CPARS).

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 below.

9. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

CONTRACT DEFICIENCY REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER

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

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