D.1 - Quality Assurance Plan.pdf

ATTACHMENT D.1 QUALITY ASSURANCE SURVEILLANCE PLAN

(QASP)

Interoperative Neuromonitoring

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. 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 Contracting Officer (CO): Keo R. Stephanie Stephanie.Keo@va.gov 713-794-8055

• Assigned Contract Specialist: Troy Davis troy.davis@va.gov 713-770-2659

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

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(S): Primary: Joshua Check – Business Manager – Joshua.check@va.gov – 501-257-6816

Alternate: Tyler Jacobs - Surgery Service ADPAC - Tyler.Jacobs@va.gov – 501-257-6827 Organization or Agency: CAVHS Department of Veteran Affairs

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

Primary: Business Manager – (Name, e-mail, and phone number) Alternate: (Name, e-mail, and phone number)

4. PERFORMANCE STANDARDS

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these 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 mailto:Stephanie.Keo@va.gov mailto:troy.davis@va.gov mailto:Joshua.check@va.gov mailto:Tyler.Jacobs@va.gov 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.

QUALITY ASSURANCE SURVEILLANCE PLAN

Measures Reference Performance Requirement

Standard Acceptable Level Surveillance Method

Met AQL/DID NOT

MEET AQL-

CPAR RATING/ADD

COMMENTS

Provider quality Performance

4.6.4.1 All physicians

contracting staff shall perform in accordance with clinical standards

100% of care provided within in clinical standards of care

100% inspection

Qualifications of Key Personnel

4.6.4.2 All (100%) of

Contractor’s physicians(s) and providers of care are licensed in the state of Arkansas and board eligible

All (100%) of Contractor’s providers of care are licensed and board eligible.

100% Random inspection of qualification documents

Scope of Practice/Privileging

4.6.4.3 All (100%) of

Contractor’s physicians(s) and providers of care perform within their individual scopes of practice/privile ging

All (100%) of Contractor’s providers of care perform within their scope of practice/privilege s 99% of the time

All (100%) of Contractor’s providers of care perform within their scope of practice/privilege s 99% of the time

Random inspection of records

Patient Access 4.6.4.4 Contractor’s physicians(s) and providers of care shall be available and in location as needed to properly perform tasks as specified

All (100%) Contractor’s physicians(s) and providers of care are on time and available to perform services

Contractor’s physicians(s) and providers of care are on time and available to perform services 100% of the time

Periodic sampling of late case start metrics

Patient Safety 4.6.4.5 Patient Safety incidents shall be reported using patient safety report.

All incidents reported immediately (within 24

All (100%) of patient safety incidents are reported using patient safety report within 24 hours of incident

100% of patient safety incidents are reported using patient safety report within 24 hours of incident.

Direct observation/rando m sampling of BioMedical Engineering inspections hours) Maintains licensing, registration, and certification

4.6.4.6 Updated

licensing, registration, and certification shall be provided as they are renewed.

Licensing and registration information are to be kept current

All (100%) licensing, registration(s), and certification(s), for Contractor’s physicians(s) and providers of care shall be provided as they are renewed.

Licensing and registration information kept current

(100%) licensing, registration(s), and certification(s), for Contractor’s physicians(s) and providers of care shall be provided as they are renewed.

Licensing and registration information kept current. No acceptable deviation

Periodic sampling and random sampling

Mandatory Training 4.6.4.7 Contractor shall complete all required training per VAMC policy

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

90% of completions

Periodic Sampling

Medical records 4.6.4.8 All medical records concerning the veteran's surgical care will be readily accessible to VA and VA surgeons in real time

All (100%) of neuromonitoring reports/status will be available in real time during operation to Surgeon(S) involved in surgery

100% compliance

Direct Observation

Privacy, Confidentiality, and

HIPAA

4.6.4.9 Contractor is

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

Zero breaches of privacy or confidentiality shall occur

All (100%) of Contractors physicians(s) and providers of care will comply with all laws, regulations, and policies and procedures relating to privacy, confidentiality and HIPAA

100% compliance with all laws, regulations, policies and procedures as indicated in 6500.6

Direct Observation

Billing for services 4.6.4.10 Invoices shall be timely and accurate for all items billed.

100% of invoices are submitted timely.

100% Periodic Reviews and spot checks

5. INCENTIVES/DEDUCTS

The government shall not use past performance as incentives

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance.

a. DIRECT OBSERVATION

b. PERIODIC INSPECTION

c. USER SURVEY

d. VALIDATED USER/CUSTOMER COMPLAINTS

e. INSPECTION

f. PERIODIC SAMPLING

g. RANDOM SAMPLING

h. PROGRESS OR STATUS MEETINGS

i. ANALYSIS OF CONTRACTOR’S PROGRESS REPORTS

7. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

8. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive OR NEGATIVE performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the COR shall work with the Contracting Officer (CO) inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case, the COR shall document the discussion and place it in the COR file. In order to assure that the contractor receives impartial, fair, and equitable treatment under this contract, the COR will work with the contractor to increase performance to an acceptable level.

When the COR and CO determines formal written communication is required, the COR and CO shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

See above Acceptable Quality Level & Method of Surveillance located in QASP

The contractor shall acknowledge receipt of the CDR in writing. The CDR 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 CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the

CO.

9 . FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.

During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR shall meet with the contractor as needed to assess performance and shall provide a written assessment.

Signature – Contractor

Signature – Contracting Officer Representative

Various methods exist to monitor performance.