Attachment D1 - 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: John Mingo

Organization or Agency:

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: N/A

Organization or Agency:

3. CONTRACTOR REPRESENTATIVES

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

Primary:

Michael Galiardi

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.

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. As part of Focused Professional Performance Review and Ongoing Professional Practice Review, a minimum of five (5) chart reviews will be conducted based upon published clinical evaluation criteria.

c. VALIDATED USER/CUSTOMER COMPLAINTS.

d. RANDOM SAMPLING.

e. VERIFICATION OF DOCUMENTATION SUBMITTED BY CONTRACTOR.

6. 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.

95% meet

ACR

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 ___Identify

VAMC Staff __________ for ________ Service.

OPPE data should include the following elements:

A. Patient Care

Performance

B. Medical/Clinical knowledge

C. Practiced Based

Learning and

Improvement

D. Interpersonal and

Communication 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; 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 shall be board certified and in accordance with national recognized accrediting body standards; 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 ACR standards must

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

Patient Access 4.6.4.4 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 95% of the time

Periodic Inspection of Time and Attendance Sheets

Patient Safety/Radiation Safety

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

Chart Review/Physics Check/Consults are completed weekly.

100% Random Sampling and Periodic Inspection

Maintains licensing, registration, and certifications

4.4.4.5

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

100% Licensing registration information kept current.

100%

Random Sampling and

Mandatory Training

4.6.4.6

a. 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

4.6.4.7

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

4.6.4.8 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

4.6.4.9 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

4.6.4.10 All notes must be

electronically signed, and all encounters closed within 24 hrs.

Compliance with VA Rules and Regulations.

95% Random Sampling and

Peer Review Conferences/

Chart Rounds

4.6.4.11 Conduct Weekly Peer

Review Conferences/Chart Rounds as required by the PWS.

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

90% Inspection and verification and/or documentation provided by contractor

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/documents/CPARS- Guidance.pdf:

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).

UNSATISFACTO

RY:

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 https://www.cpars.gov/documents/CPARS-Guidance.pdf https://www.cpars.gov/documents/CPARS-Guidance.pdf 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 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 must 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:

Michael Galiardi DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

CONTRACT REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS ISSUE

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

Date32_af_date: 5/2/24