36C25619Q0092-003.pdf

ATTACHMENT D.1 - QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Version 0008 Dated 12/1/2016

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: Stephanie Keo Organization or Agency: Network Contracting Office 16 (NCO16)

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: Temenit Asgedom Organization or Agency: MEDVAMC Management and Program Analyst, Diagnostic & Therapeutic Care Line

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. 100% surveillance: Direct Observation Surveillance will be accomplished during the day Monday – Friday from 8:00am to 4:30pm. Surveillance will consist of visual observation and medical record reviews to ensure contract physicists are providing safe and appropriate patient care within the standard of care.

b. PERIODIC INSPECTION. Announced and unannounced inspections of the contract staff working on site in the Radiation Oncology Department will occur and will be reported quarterly per COR delegation or as needed. A minimum of five (10) randomly selected Radiation Oncology QA reports will be reviewed per quarter. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards. Ten (10) randomly selected reports will be reviewed per inspection period. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Customer Service complaints will be reported and tracked by the COR and reported at least quarterly to the contractor. Customer Service complaints will be investigated by the Chief of Radiation Oncology, the COR or designee to ascertain the validity and nature of the complaint. Substantiated complaints shall be less than two (2) per year per contract physicist.

d. RANDOM SAMPLING. A minimum of five (10) randomly selected Radiation Oncology QA reports will be reviewed per quarter. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards. Ten (10) randomly selected reports will be reviewed per inspection period.

All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.

e. Verification and/or documentation provided by Contractor. Qualification and licensure documentation will be verified initially at the award of the contract and semi-annually thereafter.

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

4.6.1 Physicists, shall be Board Certified in

accordance with ACR 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.

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

Standard Operating Procedures (SOP) for all radiotherapy techniques

4.6.2 Reviewable documentation of all SOPs

shall be maintained. Radiotherapy techniques such as 3DCRT, IMRT, IGRT, SBRT, SRS, Brachytherapy have written procedures.

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

90% Periodic sampling

Quality Assurance/Quality Improvement (QA/QI) Documentation

4.6.3 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 standards and reported as required to Tumor Board.

90% Periodic sampling

ACR Radiation Safety Standards

1.1 4.2

4.5.2

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.

All (100%) Radiation safety standards and external review requirements shall be met, including those of the NRC and the NHPP.

Quality Management report shall be submitted to the MEDVAMC Radiation Safety Committee.

90% Periodic Inspection

Patient Safety/ Radiation Safety

4.5.3.1 Patient safety incidents, including misadministration, must be reported.

100% of incidents reported promptly (within 24 hours of discovery)

90% Direct Observation

Chart Review/Physics Check/Consults

4.4.3.4

Completion deadlines met as assigned by Radiation Oncology Service Administration/COR

Chart Review/Physics Check/Consults are completed weekly.

90%

Periodic Sampling and Random Sampling

Medical Physicist Reports demonstrate ACR Standards

4.6.5

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 (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

90%

Periodic Sampling

Maintains licensing, registration, and certifications

2.1.1 Updated Licensing, registration and

certifications will be provided as they are renewed.

100% Licensing and registration information kept current.

100% Periodic Sampling

Training (VA Mandatory)

2.1.6 Contractor completes all mandatory

required training

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

90% Contractor to provide documented evidence

Medical Records, Privacy, Confidentiality and

HIPAA

4.3.1 Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA 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

2.2

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.

90% COR notification of complaints

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.

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