D.1 - Quality Assurance Surveillance Plan.docx

Quality Assurance Surveillance Plan (QASP) The contractor shall 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 shall be monitored?

· How shall monitoring take place?

· Who shall conduct the monitoring?

· How shall 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. It is the VA’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the VA may review and revise it on a regular basis. However, the VA shall coordinate changes with the contractor through contract modification. Copies of the original QASP and revisions shall be provided to the contractor and VA officials implementing surveillance activities.

2. VA 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: Samantha Shackelford, Contracting Officer Organization or Agency: VA, NCO 9

b. Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the contract and shall assure proper VA 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 VA’s behalf.

Assigned COR: Henrietta Jones-Puckett, Program Specialist Organization or Agency: VA, TVHS

3. CONTRACTOR REPRESENTATIVES

The following employee(s) of the contractor serve as the contractor’s program manager(s) for this contract:

Primary Program Manager:

Alternate Program Manager:

4. PERFORMANCE STANDARDS

The contractor is responsible for performance of ALL terms and conditions of the contract. CORs shall 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 VA performs surveillance to determine the level of contractor performance to these standards.

The Performance Requirements are listed below in Section 6. The VA 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 shall 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.

DIRECT OBSERVATION. 100% surveillance

a. DIRECT OBSERVATION. Perfusionists will submit the Cardiopulmonary Perfusion Record into the perfusion file located in the OR office; these records will be submitted for both OR and out-of-the-OR procedures. Contractor’s Perfusionists are required to sign in and out of the Vendor Log located in the OR office for OR procedures.

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed. The contract COR will certify the case type and charge for rendered services. All adverse actions shall be reported to the Contracting Officer immediately. The Contracting Officer and COR shall examine methodologies and quality control procedures during the contract term. All activities shall comply with Joint Commission standards and the policies and procedures of the VAMC.

c. VALIDATED USER/CUSTOMER COMPLAINTS. The COR will be responsible for monitoring the Contractor’s performance, any incidents of customer complaints must be forwarded immediately to the Contracting Officer. The Contracting Officer is final authority on validating complaints.

d. RANDOM SAMPLING. Quality Improvement data may be collected for ongoing monitoring.

e. VERIFICATION AND/OR DOCUMENTATION PROVIDED BY CONTRACTOR. Contractor’s Perfusionists are required to sign in and out of the Vendor Log located in the OR office for OR procedures. Procedure documentation shall also be maintained by the Contractor.

36C24926R0040 f.

6. SAMPLE QASP PERFORMANCE REPORT DATE: __________________

Reference

Performance Requirement

Method Met AQL/DID NOT MEET AQL-

CPARS RATING/ADD COMMENTS

a. Patient Care Performance

b. Medical/Clinical knowledge

c. Practiced Based Learning & Improvement

d. Interpersonal & Communication Skills

e. Professionalism f-system Based Practice

All incidents shall be reported immediately (within 24 hours)

Random Sampling

Periodic Inspection and Random Sampling

Contractor personnel(s) shall provide evidence of annual training required by VAMC, reports violations per VA Directive 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)

Note: To justify an Exceptional rating, you should identify multiple significant events in each category and state how it was a benefit to the VA. 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.

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 VA. Also, there should have been NO significant weaknesses identified.

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.

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 VA. 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).

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 VA. 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. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement. The frequency of measurement is defined in the contract or otherwise in this document. The government (COR or CO) will periodically analyze whether the frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Reporting. The COR shall communicate with the Contractor and will provide written reports to the Contracting Officer quarterly (or as outlined in the contract or COR delegation) to review Contractor performance.

10. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

CONTRACT DISCREPANCY REPORT

5. DATES

a. CDR PREPARED

6. DISCREPANCY OR PROBLEM (Describe in detail. Include reference to PWS Directive; attach continuation sheet if necessary.)

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.)

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

a. CONTRACTOR NOTIFIED

b. COR

c. CONTRACTING OFFICER