D.2 Quality Assurance Surveillance Plan (QASP).pdf

Quality Assurance Surveillance Plan (QASP)

Histology Services Laboratory Testing Services

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:

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: Martha Goodwin

Organization or Agency: VA Northern California Health Care System, Sacramento VA Medical Center, Pathology & Laboratory Medicine Service

3. CONTRACTOR REPRESENTATIVES

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

Primary: Pending

Alternate: Pending

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 Government shall use past performance as incentives. Incentives shall be based on ratings received on the performance standards.

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. DAILY INSPECTION OF THE RESULTS. 100% surveillance

b. RANDOM/MONTHLY OBSERVATION. Inspections performed and reported quarterly per COR delegation or as needed.

In order to adequately document services provided under this contract, a record-keeping system of Contractor workload performed shall be established and implemented by the VA. The COR is responsible for verifying all

Contractor activities, including the tests processed, and for certifying payment of services provided. The COR will monitor the quality of all Contractor activities through various VA clinical and laboratory staff members.

c. VALIDATED USER/CUSTOMER COMPLAINTS.

d. RANDOM SAMPLING.

e. VERIFICATION AND/OR DOCUMENTATION PROVIDED BY THE CONTRACTOR.

All record-keeping and documentation collected and maintained by the COR shall be accurate, complete and current, and is subject to review by the CO at any time. After contract award, any incidents of Contractor non-compliance with the terms of this contract, as supported by record-keeping documentation, shall be forwarded immediately to the CO. Quarterly, the COR will provide a written statement to the CO to include a summary of

Contractor actions and a statement indicating whether all requirements of the contract have been fulfilled as agreed.

The following performance measures will be utilized by VA in monitoring Contractor performance.

Performance

Measure

PWS

Reference

Performance

Requirement

Standard Acceptable Quality

Level

Surveillance

Method

Incentive Disincentive

Licensing, Accreditation

Certification

2.1 Contractor must

provide CLIA

Certification and

CAP Accreditation, or equivalent

Proper certification

100% meets

Standards

Presented by the

Contractor with

Qualifications and as updated/renewed

Favorable

Contractor performance evaluation

Termination of the contract

Technical

Quality

4.9.3;

4.20

Produce high-quality, consistent test results considered by VA to be acceptable for proper diagnosis

Meets quality requirements

95% meets Standards Daily (100%) test results correlated with clinical diagnosis

Favorable

Contractor performance evaluation

Unfavorable

Contractor performance evaluation;

termination of the contract.

Timeliness 4.4 Process specimens and report test results within timeframes stated in contract

Timely processing of specimens and reporting of results

Reporting of results:

• Delayed up to 48 business hours – from the published turnaround times.

Daily (100%) observation of receipt of results by

COR and VA

Laboratory staff

Favorable

Contractor performance evaluation

Unfavorable

Contractor performance evaluation;

registration with

CPARS; termination of the contract.

Invoicing 6.2 Contractor shall electronically submit accurate and timely monthly invoices

Accuracy and timeliness of invoice submissions

95% meets Standards Monthly observance by COR

Favorable

Contractor performance evaluation

Unfavorable

Contractor performance evaluation;

registration with

CPARS.

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).

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).

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 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.

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:

Martha Goodwin, COR DATE

SIGNED:

Contractor Name, Title DATE