36C25019Q1240-002.pdf

Quality Assurance Surveillance Plan (QASP)

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CO2 laser

The contractor will 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 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 CO:

Organization or Agency: VHA VISN 10 Contracting Office

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.

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Assigned COR: Daniel J. Weir

Organization or Agency: Surgery Service, VA Ann Arbor Health System, Ann Arbor Michigan

3. CONTRACTOR REPRESENTATIVES

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

Contact: Justin A. Dedecker 1-734-845-5935.

4. 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.

6. 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: The COR will evaluate performance through observation conducted by the VAAAHS surgery team. Members include the Surgeon and all VAAAHS staff members, contracted or employee, in the surgical suite during any portion of the procedure/surgery. The staff will report, either independently of the COR or when asked by the COR, the performance of the vendor based upon the QASP below.

b. PERIODIC INSPECTION.The COR will inspect monthly invoices for accuracy and timeliness.

c. VALIDATED USER/CUSTOMER COMPLAINTS. If any complaints regarding the vendor’s performance are reported to the COR by staff, patient or patient champion, the COR will investigate as is appropriate. Interviews of staff and CPRS will be primary tools of discovery.

Measures PWS

Reference

Performance Requirement Standard Acceptable Quality

Level

Surveillance

Method

Incentive Disincentive/Deduct

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1- Patient

Access

PWS

Paragraph 1

Contract Technologist (s) and appropriate equipment shall be available and in location as needed to properly perform tasks as specified.

VAAAHS will schedule all cases and will provide the

Vendor 24 hours notice. The Vendor may not cancel any cases

95% - Only with prior notice to

VAAAHS and with

VAAAHS approval

All cases delayed or cancelled due to Vendor behavior will be reported to the COR

Favorable contactor performance evaluation.

Unfavorable contractor performance evaluation

2 - Maintains licensing, registration, and certification

PWS

Paragraph 1

Updated Licensing, registration and certification shall be provided as they are renewed. Licensing and registration information kept current.

All Vendor

Technologists, or any person provided by the

Vendor, who provides CO2 laser support in the OR, will be adequately trained and certified

95% - Only with prior notice to

VAAAHS and with

VAAAHS approval

Periodic

Sampling and Random

Sampling

Favorable contactor performance evaluation.

Unfavorable contractor performance evaluation.

Possible termination of contract.

3 – Maintains adequate number availability of staff with required NACI security approval

PWS

Paragraph 6

“VISN 11

Personal

Security

Verification

(PIV) Card and/or

Security Badge

Requirements for

Contractor

Employees”

VAAAHS requires that all

Vendor staff participating in a

CO2 laser surgical case will have a current NACI clearance and active PIV badge

All Vendor

Technologists, or any person provided by the

Vendor to participate in the case, will demonstrate security clearance with a current PIV badge

100% - Security requirement will not be waived under any conditions

OR staff will establish PIV demonstration before entrance to

OR suite.

Favorable contactor performance evaluation.

Unfavorable contractor performance evaluation.

Possible termination ofcontract.

4 – Quality control

PWS

Paragraph 1

Vendor shall provide quality services as described in the

The Vendor will provide service at

95% - It is expected that there will be no

The surgeon will be solely

Favorable contactor

Unfavorable contractor performance evaluation.

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PWS such a level of performance/quality such that cases are not delayed or cancelled due to

Vendor behavior systemic or continuous/repeated quality issues responsible for determination of quality provided by the Vendor and will notify the COR who will investigate and notify the

Vendor. The

COR will then observe for quality corrections and improvements performance evaluation.

Possible termination ofcontract.

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The table below is a sample that can be tailored – note that the table must identify where in the PWS the standards are found for monitoring performance. Check the MSO Customer Resource Center for approved mandatory QASPs.

7. RATINGS

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

EXCEPTIONAL: 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).

UNSATISFACTO

RY:

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).

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8.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 perparing 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.

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

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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:

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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