D.1 Attachment 1- Neuromonitoring QASP.pdf

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36C25626Q0004- NEW ORLEANS NEUROMONITORING CANCELLED
Solicitation number
36C25626Q0004
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This document is a Quality Assurance Surveillance Plan (QASP) for an Interoperative Neuromonitoring contract with the U.S. Department of Veterans Affairs. The QASP outlines the government's method for evaluating contractor performance, with key personnel including Contracting Officer Stephanie Keo and Contracting Officer's Representative Gerald Bailey. The surveillance plan establishes detailed performance standards for providers, including requirements that 100% of physicians: perform within clinical standards, are licensed and board eligible, work within their scope of practice, are available and on time, report patient safety incidents within 24 hours, maintain current licensing and registration, and complete mandatory training.

The document describes four primary methods of quality assurance surveillance: direct observation (100% surveillance), periodic inspection, validated user/customer complaints, and random sampling. Performance will be evaluated using a rating system ranging from Exceptional to Unsatisfactory, with quarterly progress reports submitted by the Contracting Officer's Representative. The QASP is designed to be a "living document" that can be reviewed and revised regularly, with the fundamental premise that the contractor is responsible for management and quality control to meet contract terms. The plan includes a contract report template for documenting and addressing any performance issues that may arise during the contract period.

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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 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.

fair, and consistent in evaluating performance.

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

Assigned CO: Stephanie Keo, stephanie.keo@va.gov, 713-794-8055

Organization or Agency: U.S. Department of Veterans Affairs

b. The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the

. The COR is not empowered to make any contractual commitments or to authorize any contractual

Assigned COR: Gerald Bailey, Gerald.bailey2@va.gov, 504-507-2000 ext 62419

Organization or Agency: U.S. Department of Veterans Affairs

3. CONTRACTOR REPRESENTATIVES

The following for this contract.

Primary Program Manager: _________________________________________________ Alternate Program Manager:

PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the

Quality Assurance Surveillance Plan 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.

4. 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: Operating staff reports delays caused by contractor to COR.

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. Ensuring all certification is completed and maintained, verifying with Medical Staff Office.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Providers will provide information for customer complaints to COR.

d. RANDOM SAMPLING. All reviews and reports will be conducted in compliance with VA Privacy and Information security standards.

5. SAMPLE QASP PERFORMANCE Report DATE: _ _______

6. QUALITY ASSURANCE SURVEILLANCE PLAN

7. Interoperative Neuromonitoring

Measures Reference Performance Requirement

Standard Acceptable Level Surveillance Method

Met AQL/DID NOT

MEET AQL-

CPAR RATING/ADD

COMMENTS

Provider quality 2.3 All physicians 100% of care 100% inspection Performance contracting provided within staff shall in clinical perform in standards of care accordance with clinical standards

Qualifications of Key 2.8 All (100%) of All (100%) of 100% Random inspection Personnel of qualification physicians(s) providers of care documents and providers are licensed and of care are board eligible.

licensed in the state of Arkansas and board eligible

Scope of 2.3 All (100%) of All (100%) of All (100%) of Random inspection Practice/Privileging of records physicians(s) providers of care providers of care and providers perform within perform within of care perform their scope of their scope of within their practice/privilege practice/privilege individual s 99% of the time s 99% of the time scopes of practice/privile ging

Patient Access 2.3 All (100%) Periodic sampling physicians(s) physicians(s) and of late case start and providers physicians(s) and providers of care metrics of care shall be providers of care are on time and available and in are on time and available to location as available to perform services needed to perform services 100% of the time properly perform tasks as specified

Patient Safety 2.3.1 Patient Safety All (100%) of 100% of patient Direct incidents shall patient safety safety incidents observation/rando be reported incidents are are reported m sampling of using patient reported using using patient BioMedical safety report. patient safety safety report Engineering All incidents report within 24 within 24 hours inspections reported hours of incident of incident.

immediately (within 24 hours)

Maintains licensing, 2.8 Updated All (100%) (100%) licensing, Periodic sampling registration, and licensing, licensing, registration(s), and random certification registration, registration(s), and sampling and and certification(s), certification certification(s), for shall be for physicians(s) and provided as physicians(s) and providers of care they are providers of care shall be provided renewed. shall be provided as they are Licensing and as they are renewed.

registration renewed. Licensing and information are Licensing and registration to be kept registration information kept current information kept current. No current acceptable deviation

Mandatory Training 2.11 Contractor shall complete all required

All (100%) of required training is complete on

90% of completions

Periodic Sampling training per time by VAMC policy physician(s).

Billing for services 2.1.2 Invoices shall be timely and accurate for all items billed.

100% of invoices are submitted timely.

100% Periodic Reviews and spot checks

8. 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 . 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

. 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 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:

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 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).

9. 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 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.

10. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

Gerald Bailey/COR DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

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

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