36C25720Q0044-035.pdf

Quality Assurance Surveillance Plan (QASP)

Neuromonitoring Equipment and Technician Services PWS

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): Yomika Brock

• Assigned Contract Specialist: Robert Moffett

• 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): Rebecca Quinn

c. Other Key Government Personnel

3. CONTRACTOR REPRESENTATIVES

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

a. Program Manager – As assigned by facility

b. Other Contractor Personnel - As assigned by facility

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.

QUALITY ASSURANCE SURVEILLANCE PLAN

Nursing Home Care

No. Paragraph in PWS

Indicator/Performance Standard

Standard for

Quality Level

Acceptable Quality Level

Method of Surveillance1

Incentive

1 B.3.4.1.1 Upon arrival at the VA the Contractor shall take all equipment to BioMed

Service for preoperative electrical safety check.

100% 100% Periodic Reviews and spot checks

Positive past performance rating

2 B.3.4.1.3 The Contractor shall maintain equipment in accordance with manufacture’s specifications. The

Contractor shall provide written documentation of

Preventive Maintenance

Services

(PMS)/Maintenance has been performed as required for verification by the COR or his/her designee for all scheduled services.

100% 100% Periodic Reviews and spot checks

Positive past performance rating

3 B.3.4.2 Provides 24/7 onsite case coverage and scheduling

365 days/year with fully credentialed

Neurophysiologists available for onsite coverage before and during surgery, (up to 3 if required).

100% 95% Periodic Reviews and spot checks

Positive past performance rating

1 See “Methods of Surveillance,” paragraph 6 of this QASP, for additional methods of monitoring performance.

4 B.3.4.2 Neuromonitoring teams accredited by ABRET, (American Board of

Registration of

Electroencephalographic and Evoked Potential

Technologist).

100% 100% Periodic reviews

Positive past performance rating

5 B.3.4.2 Certificate of

Neurophysiologic intraoperative monitoring

(CNIM) 80% of techs or more.

80% 80% Periodic Reviews and spot checks

Positive past performance rating

6 B.3.4.2 Intraoperative monitoring modalities needed include: SSEPS, TcMEP, S-EMG, T-EMG, spinal cord mapping including

D-Waves, DNEPs, NMEPs, Cortical, motor, sensory, language mapping, white matter tract and brainstem nuclei mapping, brainstem auditory evoked responses, visual evoked potentials, cranial nerve monitoring, and intraoperative EEG.

100% 95% - 100%

Periodic Reviews and spot checks

Positive past performance rating

5. 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.

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.

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

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