36C25020Q0311-005.pdf

Attachment D4 - QASP

QUALITY ASSURANCE SURVEILLANCE PLAN

In Home Sleep Study Monitoring Services

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):

• Assigned Contract Specialist:

• 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):

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.

Task Standard

Performance Threshold/ Acceptable

Quality Level

Method of Surveillance

Performance Acceptable/

Unacceptable

PERSONNEL: Contractor shall provide a Board- Certified Sleep Medicine Physician (BCSMP) to review and interpret the raw data of the sleep study epoch by epoch and provide a report to the ordering physician

100% during annual rating period

Periodic Reviews and spot checks.

The Government may, at its discretion, choose any time, announced or unannounced, to have VA personnel inspect the contractor’s facility and processes.

YES ☐

NO ☐

EQUIPMENT: The contractor shall furnish, for the life of the contract, the following equipment at no additional costs to the Government;

1. Personal sleep monitors and equipment

2. Current operator’s manual(s)

The system shall have an on-board manual to include system operation and troubleshooting.

The contractor shall repeat the monitoring study within 72 hours at no additional costs to the government for reasons including, but not limited to, device provides unsatisfactory results, device fails to transmit or download

95% of referred cases

Quarterly record review.

The Government may, at its discretion, choose any time, announced or unannounced, to have VA personnel inspect the contractor’s records.

information, information is not retrievable through the use of the web-based system, or there is an imaging defect or artifact determined by the VA to be substandard.

All equipment offered shall be FDA approved.

MONITORING

SERVICES:

Monitoring Service/ The contractor shall provide On-Call services for patients and VA staff shall be available 24 hours a day, 7 days a week.

Contractor shall have a Board-Certified Sleep Specialist on Staff and be available at all times to perform interpretations that are of an acute nature

95% of referred cases

Periodic Reviews and spot checks

YES ☐

NO ☐

INSTRUMENT

CAPABILITIES:

The contractor shall have a Sleep Study Type 3 Recording device. Equipment used for home sleep testing must comply with the accreditation standards set for Out of Center Sleep Testing (OCST) equipment by the American Academy of Sleep Medicine

(AASM)

100% during annual rating period

Periodic Reviews and spot checks

The Government may, at its discretion, choose any time, announced or unannounced, to have VA personnel inspect the contractor’s equipment.

YES ☐

NO ☐

TRAINING: The contractor shall provide comprehensive training to the VA Medical Center.

Multiple training Sessions may be required for numerous staff members. The training shall consist of proper use of the monitoring devices, instructions on how to upload patient

95% of referred cases

Periodic Reviews and spot checks information into contractor provided software and/or websites, and how to maintain or provide basic quality assurance tests.

TECHNICAL

SUPPORT:

Technical Support is required by the contractor via telephone for troubleshooting of method and/or problems 24/7. The response time for telephone technical assistance shall be within one (1) hour from the time of the initial call for technical support.

100% of referred cases

Periodic Reviews and spot checks

YES ☐

NO ☐

BILLING/INVOICING: The Contractor shall submit an original monthly invoice and supporting documentation for the previous month’s services Invoices no later than the 15th workday of the month.

Invoices without proper Documentation shall be returned, and no advance payments shall be authorized.

95% of referred cases

Quarterly record review.

5. INCENTIVES/RATING STANDARDS

N/A

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.

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.

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

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

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

CONTRACTOR

NOTIFIED

COR

CONTRACTING

OFFICER

Various methods exist to monitor performance.