Quality Assurance Surveillance Plan.pdf

Quality Assurance Surveillance Plan (QASP)

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 CO: Contracting Officer- NCO19

Organization or Agency: NCO 19

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.

Primary COR: COR for RMRVAMC

Quality Assurance Surveillance Plan

Organization or Agency:

1. Contractor Representatives

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

Primary:

Alternate:

2. Performance 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 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.

3. 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: Chief, CT will observe services in OR

b. PERIODIC INSPECTION. Inspections scheduled and reported quarterly per COR delegation or as needed.

c. VALIDATED USER/CUSTOMER COMPLAINTS. Complaints will be validated by the COR through Chief and CO

d. RANDOM SAMPLING.

e. Verification and/or documentation provided by Contractor.

4. SAMPLE QASP PERFORMANCE REPORT DATE: __________________

Measures PWS Reference

Performance Requirement

Standard Accepta ble Quality Level

Surveillance

Method

Met AQL/DID

NOT MEET

AQL-

CPAR

RATING/ADD

COMMENTS

1 - Qualifications of Key Personnel

4.6.4.2. All contract

Perfusionists shall have current certification in accordance with American Board of Cardiovascul ar Perfusion and maintain license, registration and/or certification

All Perfusion ists shall be certified and compliant with all certificati ons

100% Random Inspection of qualification documents

2 – Scope of Practice/Privile ging

4.6.4.3. Contract

personnel (s) perform within their individual scopes of practice/privil eging

All (100%) contract personnel (s) perform within their scope of practice/p rivileges 100% of the time

100% Random inspection of records

3 – Patient Access (A)

4.6.4.4. Patient must

receive treatment in a timely manner

Perfusion ists shall be onsite and available during all schedule d OR hours and within 30 minutes of the facility

100% Direct Observation and random Inspection

4- Patient Access (B)

4.6.4.5. Perfusionists

shall be available and be in location as needed to properly perform tasks as specified

Perfusion ists shall be onsite and available during all schedule d OR hours and within 30 minutes of the facility

100% Periodic sampling of time and attendance sheets

5. -Patient Safety

4.6.4.6. Patient safety

incidents shall be reported using Patient Safety Report

All incidents shall be reported immediately (within 24 hours)

All of patient safety incidents are reported using Patient Safety Report within 24 hours of incident

95% Direct observation and periodic inspection

6 – Maintains licensing, registration, and certification.

4.6.4.7. Updated

Licensing, registration and certification shall be provided as they are renewed

Licensing and registration information shall be kept current

All licensing, registratio n(s) and certificati on(s) for contract personnel

(s) shall be provided as they are renewed Licensing and registratio n informatio n shall be kept current

100% Periodic Sampling

7 – Mandatory Training, Privacy, Confidentiality and HIPAA

4.6.4.8. Contractor

personnel (s) shall complete all required training on time per VAMC policy.

Contractor personnel (s) is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentialit y, and HIPAA and complies with all standards Zero breaches of privacy or confidentiality

All contracto r personnel

(s) shall comply with all laws, regulation s, policies and procedur es relating to Privacy, Confident iality, and

HIPPA.

100% Periodic sampling

Contractor personnel (s) shall provide evidence of annual training required by

VAMC,

reports violations per VA Directive 6500.6

8 – Clinical Information Return

4.6.4.9. Perfusionists

shall be responsible to check and compute all calculations of perfusion, autotransfusi on and cell saver treatments.

All cases 100% Direct observation sampling.

9 – Documentation /Timesheet

4.6.4.10. Time sheet

documentatio n to be completed weekly and turned in to Section Chief for concurrence

Weekly 95% Periodic inspection sampling

5. Ratings

Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used:

Outstanding: Performance meets contractual requirements and exceeds many to the Government’s benefit. 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: Performance meets contractual requirements and exceeds some to the Government’s benefit. 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: 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: 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 contractor’s proposed actions appear only marginally effective or were not fully 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: 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 assessed contains serious problem(s) for which the contractor’s corrective 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).

6. 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 REPORT

(CPAR).

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 Discrepancy Report (CDR), 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 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 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 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 CDR below.

7. 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.

8. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

PRIMARY COR DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

CONTRACT REPORT

1. CONTRACT NUMBER 2. Report Number for this Discrepancy

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