Attachment I - QASP.pdf

Quality Assurance Surveillance Plan (QASP)

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Diagnostic Medical Physicist Services for Calibrating/Inspecting Imaging Equipment

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 through contract modification. 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: Department of Veterans Affairs, VA Ann Arbor Healthcare System

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: Yvette M. Harden, Health Physicist, Radiation Safety Officer for Machines

Organization or Agency: Department of Veterans Affairs, VA Ann Arbor Healthcare System

3. CONTRACTOR REPRESENTATIVES

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

Primary: Designated upon award

Alternate: __________________________________________________

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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.

5. INCENTIVES/DEDUCTS

The following incentives shall be implemented when the contractor meets or exceeds the performance standards and contract requirements:

1. Exercise of an option; and

2. Past Performance

The following disincentives shall be implemented should the contractor fail to comply with requirements on more than two (2) occasions/incidences annually set forth in the SOW:

1. Key Personnel: All key personnel will maintain ABR license in compliance with ACR guidelines or they will be removed from the contract.

2. Imaging Equipment: All imaging equipment is calibrated/inspected annually and not to exceed 13 months and in accordance with ACR guidelines and emergency inspections due to equipment repairs have a 24 hour response or the contract may result in termination.

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. Random INSPECTION - COTR works with the Radiation Safety Officer and in-house medical physics staff to evaluate all quality control data logs/reports to ensure that processes are performed regularly and any deviation outside tolerance level is brought to the attention of the COTR.

b. Periodic Sampling. Sample results are taken when a problem/deficiency is suspected. Sample results are applicable only for the specific work inspected.

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PERFORMANCE MEASURES

Measures SOW

Reference Performance Requirement

Acceptable Quality Level

Surveillance Method

Incentive Disincentive/ Deduct

1 – Qualifications of Key Personnel

Part I: General Information- Paragraph 1

All contract Diagnostic Medical Physicist(s) shall have current board certification in accordance with ACR Standards for imaging equipment.

Zero Tolerance Initial and periodic inspection of qualification documents

Favorable contactor performance evaluation.

Unfavorable contractor performance evaluation. Removal from contract until such time the contract physicist(s) meet qualification standard.

2 – Scope of Practice/Privileging

Part I: General Information- Paragraph 1

Contract Diagnostic Medical Physicist(s) perform within their individual scopes of practice/privileging

Zero Tolerance Inspection of records.

Favorable contactor performance evaluation.

Unfavorable contractor performance evaluation. Removal from contract until such time the contract physicist(s) meet qualification standard.

3- Imaging equipment is calibrated/inspected and CT/fluoro protocols optimized annually per ACR guidelines.

Part II:

Requirements- Section 1- Paragraphs “a” & “e”. Section 2-Pages 3- 12(all content).

Contract Diagnostic Medical Physicist(s) shall be available and on location as needed to properly perform tasks as specified.

Zero Tolerance Periodic inspection of Equipment Calibration Reports

Favorable contactor performance evaluation.

Unfavorable contractor performance evaluation. Removal from contract.

4 – Maintains licensing, registration, and certification

Part I: General Information- Paragraph 1

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

Licensing and registration information kept current.

Zero Tolerance Periodic Inspection of all records

Favorable contactor performance evaluation.

Unfavorable contractor performance evaluation. Removal from contract until such time the contract physicist(s) meet qualification standard.

5 – Administration- Maintains appropriate records

Part II:

Requirments- Section 1- Paragraph “a”

Written reports shall be provided within 21 calendar days of completion of inspection.

Zero Tolerance Periodic inspection of equipment calibration reports.

Favorable contactor performance evaluation.

Unfavorable contractor performance evaluation. Removal from contract.

6 – Privacy, Confidentiality and

HIPAA

Part III:

Supporting Information- Section “A”

Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards Zero breaches of privacy or confidentiality

Zero Tolerance Contractor shall adhere to HIPPA/Privacy rules required by VAMC, reports violations per VA Directive 6500.6.

Favorable contactor performance evaluation.

Unfavorable contractor performance evaluation. Removal from contract

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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.

A sample CDR is attached.

9. FREQUENCY OF MEASUREMENT

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

b. The COR and Contractor will meet upon request of either party to assess performance and provide a written assessment.

10. COR AND CONTRACTOR ACKNOWLEDGEMENT OF QASP

SIGNED:

COR NAME/TITLE DATE

SIGNED:

CONTRACTOR NAME/TITLE DATE

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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:

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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