ATTACHMENT 1 QUALITY ASSURANCE SURVEILLANCE PLAN.pdf

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Attached to
Q523--FY27: Intraoperative Neuromonitoring (IONM) Services
Solicitation number
36C24827Q0032
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About this file

This is a Quality Assurance Surveillance Plan (QASP) for a contract with the Department of Veterans Affairs Bay Pines VA Healthcare System for intraoperative neuromonitoring (IONM) services.

The QASP establishes systematic performance evaluation methods for contractor-provided neurologist physicians and IONM technologists delivering surgical neuromonitoring services in the operating room. The Contracting Officer is Rosetta Quinn (Network Contracting Office 8, rosetta.quinn@va.gov, 813-893-1814), and the Contracting Officer's Representative is Aisha Daw (Bay Pines VA Healthcare System, Aisha.daw2@va.gov, 727-398-6661, ext. 14304). Performance standards require 100% direct observation surveillance in the operating room and include eight key performance metrics: Provider Quality Performance (compliance with American Association for Neurological Surgeons standards for physicians and American Board of Registration of Electroencephalographic and Evoked Potential Technologists standards for IONM technologists); Qualifications of Key Personnel (Board Certification and IONM/CNIM certification requirements); Scope of Practice/Privileging; Patient Access (timely availability according to VA clinical schedule); Patient Safety (incident reporting within 24 hours via VA Patient Safety Reporting System); Maintains Licensing, Registration, and Certification; Mandatory Training; and Privacy, Confidentiality, and HIPAA Compliance. Surveillance methods include 100% direct observation, periodic quarterly inspections, validated user/customer complaint feedback via PATS and JPSR systems, random sampling of patient safety reports, and verification of contractor-supplied documentation. The QASP uses CPARS ratings (Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory) to assess performance, with contract discrepancy reports issued for substandard performance requiring corrective action plans.

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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: Rosetta Quinn, rosetta.quinn@va.gov, 813-893-1814 Organization or Agency: Network Contracting Office 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: Aisha Daw, Aisha.daw2@va.gov, 727-398-6661, ext.14304 Organization or Agency: Bay Pines VA Healthcare System mailto:rosetta.quinn@va.gov mailto:Aisha.daw2@va.gov

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: 100% visual and audio surveillance of contract’s provider(s) in the Operation Room. (OR)

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. All inspections and reports will be conducted in compliance with VA Privacy and Information security standards.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Feedback via PATS (Patient Advocate Tracking System) and JPSR (Joint Patient Safety Report) will be reviewed by the COR.

d. RANDOM SAMPLING. The COR will review Joint Patient Safety Report to ensure all incidents are reported timely. All reviews and reports will be conducted in compliance with VA Privacy and Information security standards.

e. VERIFICATION AND/OR DOCUMENTATION PROVIDED BY CONTRACTOR. The contractor must supply provider qualifications, pertinent provider documents including licenses, training compliance and invoices.

6. QASP PERFORMANCE REPORT DATE: __________________

Measures PWS Reference

Performance Requirement

Standard Acceptable Quality Level

Surveillance Method

Met AQL/DID NOT

MEET AQL-

CPARS RATING/ADD

COMMENTS

Provider Quality Performance

4.5.4.1. All Contractor’s

provider(s) must perform in accordance with clinical standards and as specified in the PWS.

All (100%) of Contractor’s physician(s) must meet or exceed currently recognized national standards of the American Association for Neurological Surgeons (AANS).

All (100%) of Contractor’s IONM Technologist(s) must meet or exceed currently recognized national standards of the American Board of Registration of Electroencephalogr aphic and Evoked Potential Technologists

(ABRET).

100% Direct Observation.

Qualifications of Key Personnel

4.5.4.2. All Contractor’s

Neurologist physicians(s) must be certified by the American Board of Neurological Surgery and hold a certificate of Fellowship in Intraoperative Neuromonitoring.

All Contractor’s

IONM

technologist(s) must hold a Certificate (be certified) of Neurophysiologic Interoperative Monitoring (CNIM) from by the American Board of Registration of Electroencephalog raphic and Evoked Potential Technologists

(ABRET).

All (100%) Contractor’s physician(s) are Board Certified. All Contractor Physician(s)

(100%) IONM

certified.

Technologist(s) are ABRET certified.

100% Periodic Inspection of qualification documents.

Scope of Practice/Privileging

4.5.4.3. Contractor’s

provider(s) perform within

All (100%) Contractor’s provider(s)

Observation their individual scopes of practice/privileging perform within their scope of practice/privileges.

Patient Access 4.5.4.4. The Contractor must provide Contractor’s neurologist physician(s) and

IONM

technologist(s) in accordance with the operating hours and VA clinical schedule outlined in this

PWS.

All (100%) Contractor’s neurologist physician(s) and

IONM

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

Observation

Patient Safety 4.5.4.5. Patient safety incidents must be reported using VA Patient Safety Reporting System.

All incidents reported immediately (within 24 hours.)

All (100%) patient safety incidents are reported using VA Patient Safety Reporting System within 24 hours of incident.

100% Periodic Inspection or Random Sampling

Maintains licensing, registration, and certification

4.5.4.6. Updated

Licensing, registration and

All (100%) licensing, registration(s) and

100% Periodic Inspection or certification must be provided as they are renewed.

Licensing and registration information kept current.

certification(s) for Contractor’s neurologist physician(s) and

IONM

technologist(s) must be provided as they are renewed. Licensing and registration information kept current.

Random Sampling

Mandatory Training 4.5.4.7. Contractor must complete all required training on time per facility policy.

All (100%) of required training is completed on time by Contractor’s physician(s) and technologist(s).

100% completions

Periodic sampling of training documentation

Privacy, Confidentiality and

HIPAA

4.5.4.8 Contractor is

aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of

All (100%) Contractor’s physician(s) and technologist(s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and

HIPAA.

100% completions

Periodic Inspection or Random Sampling;

Contractor must provide evidence of annual training required by the facility, reports violations per privacy or confidentiality.

VA Handbook 6500.6.

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/cparsweb/assets/documents/CPARS_User_Manual.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-https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.cpars.gov%2Fcparsweb%2Fassets%2Fdocuments%2FCPARS_User_Manual.pdf&data=05%7C02%7C%7C1299a8a1556647c9c9b208dd897915ec%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638817875334440754%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=6A9MQEEm9YUvO1cWqDUn1sC8wYUJvuCVqG%2F2AhW8s1E%3D&reserved=0 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 VA 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 shall 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 Discrepancy Report (CDR), and present it to CO. The CO shall in turn review and shall present to the contractor's program manager for corrective action.

The contractor shall acknowledge receipt of the CDR in writing. The CDR shall 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 CDR shall also state how long after receipt the contractor has to present this corrective action plan to the CO. The VA 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 CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO. See Sample on following page.

9. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

CONTRACT DISCREPANCY REPORT

1. CONTRACT NUMBER 2. REPORT NUMBER FOR THIS DISCREPANCY

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

5. DATES

a. CDR PREPARED

b. RETURNED BY

CONTRACTOR:

c. ACTION COMPLETE

6. DISCREPANCY OR PROBLEM (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, CORRECTIVE ACTION 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. (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)

13. GOVERNMENT ACTIONS (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)

14. CLOSE OUT

NAME TITLE SIGNATURE DATE

a.

CONTRACTOR

NOTIFIED

b. COR c.

CONTRACTING

OFFICER

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