Attachment 1 QASP Radiation Oncology Therapy Services.pdf

ATTACHMENT ONE

Quality Assurance Surveillance Plan (QASP)

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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: Yamil O. Gomez

Organization or Agency: VHA Network Contracting Office (NCO) - 8

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: Jose M. Ortiz

Organization or Agency: Bruce W. Carter VAMC, Surgical Service, Miami VA Healthcare System (MVAHCS)

3. CONTRACTOR REPRESENTATIVES

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

Primary (full name/email address/phone number):

Alternate (full name/email address/phone number):

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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.

c. VALIDATED USER/CUSTOMER COMPLAINTS.

d. RANDOM SAMPLING. 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. Documentation submission by contractor for verification of completion.

Radiation Oncology Therapy Services MVAHCS

6. QASP PERFORMANCE REPORT DATE: __________________

Measure

PWS

Para.

Performance

Requirement

Standard

Acceptable Quality Level

Surveillance

Method

Met AQL/DID NOT MEET

AQL-

CPAR RATING/ADD

COMMENTS

Qualifications and Availability of Key Personnel

4.6.4.1 Radiation Oncology

Physicians, Physicists and Dosimetrists shall be board certified in accordance with radiotherapy practice standards promulgated by the ACR, ASTRO, and AAPM. 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.

100% 100% Periodic Inspection of qualification documentation and medical records submitted in accordance with contractor reporting requirements

Patient Reports and Documentation

4.4.4.2 All notes must be

electronically signed, and all encounters closed within 24 hrs.

Compliance with VA Rules and Regulations

95% Periodic Inspection and Random Sampling

Standard Operating Procedures (SOP) for all radiotherapy techniques

4.6.4.3 Reviewable

documentation of all SOP’s shall be maintained.

Radiotherapy techniques, such as

3DCRT, IMRT,

Rapidarc, Electron Therapy and IGRT, have written procedures.

100% of procedures are documented, reviewed and updated annually.

100% Random Sampling of procedure documentation and medical records submitted in accordance with facility reporting requirements

Quality Assurance/ Quality Improvement

(QA/QI)

Documentation

4.6.4.4 The contractor shall

have an operational 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

100% of

QA/QI

documents complete in accordance with ACR, ASTRO and

AAPM

standards and reported as required to VA Radiation Therapy Service QA committee.

90% Periodic inspection of

QA/QI

documents provided processes, outcomes, patient satisfaction, and quality control.

Appropriate statistical quality control techniques in compliance with ACR/APEx standards must be utilized. Results of performance improvement activities must be reported quarterly to the MVAHCS Chief Radiation Therapy service.

Maintains licensing, registration, and certifications

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

100% Licensing and registration information kept current.

100% Periodic Inspection and

Sampling

Radiation Safety Policy and Standards for Practice Accreditation

4.6.4.6 TMP is responsible for

the Radiation Safety Program (RSP) of the Radiation Oncology Service/Section. The RSP shall meet the accreditation standards of the

ACR/ASTRO

Radiation Oncology

All (100%) Radiation safety standards and external review requirements shall be met..

Quality management report shall be submitted

100%

Periodic Inspection

Program for Accreditation (ROPA).

RSP shall meet the radiation safety standards, policies and procedures set by NRC, NHPP and the ACR/ASTRO. The RSP status, to include the correction plan for all radiation safety related deficiencies noted by site surveys from ACR/ASTRO, 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 quarterly to the

MVAHCS

Radiation Safety Committee.

Patient Access

4.6.4.7 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 physician(s) are on time and available to perform services.

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

Periodic Inspection of Time and Attendance Sheets

Patient Safety/Radiation Safety

4.6.4.8 Patient safety

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

Chart Review/Physic s Check/Consult s are completed weekly

100% Periodic

Provider Quality Performance

4.6.4.9 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 (3) months, six

(6) months and semi-annually thereafter.

The OPPE data shall be provided to MVAHCS COR, Jose M. Ortiz. OPPE data should include the following elements:

a. Patient Care Performance

b. Medical/Clinical knowledge

c. Practiced Based Learning and Improvement

100% OPPE

documentation for all staff providing services under the contract.

100% meet ACR/APEx standards

Periodic and

d. Interpersonal and Communication skills

e. Professionalism

f. System Based practice

Cancellations/ Rescheduling

4.6.4.10 Contractor shall be

responsible for cancelling appointments in accordance with the following procedures:

Cancellation of patient appointments within 2 weeks of appointment.

Comply with no cancellation due to contractor absence.

90% Direct observation, validated patient complaints

Privacy, Confidentiality and HIPAA

4.6.4.11 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

4.6.4.12 Contractor

employees maintain excellent relationships with patients, Radiation Oncology staff members, VA Medical Center staff

Zero complaints from VA Medical Center staff members related to the contractor’s employee

100%

COR

notification of complaints

Favorable contractor performance evaluation.

members, and vendors.

interfering with patient care or the ordinary operation of the facility.

Mandatory Training 4.6.4.13 Contractor completes all mandatory required training

All training (100%) completed as required per

MVAHCS

Policy.

100% Contractor to provide documented evidence

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.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).

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).

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 on the following page.

8. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

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CONTRACT 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