36C24220R0017-008.docx

Quality Assurance Plan VISN 2 South Prognostics, Molecular Diagnostics, and Therapeutic Referral Laboratory Services

Contract Number: ________________________

Contract Description:

The James J. Peters VA Medical Center, Northport VA Medical Center, New Jersey VA Healthcare System, Hudson Valley VA\Healthcare System and New York Harbor VA Healthcare System (hereafter referred to collectively as VISN 2 South throughout the remainder of this document), are committed to providing quality health care to the Veteran Population served. The Genetics and Esoteric Testing Departments Pathology and Laboratory Services are a critical component for addressing health care needs of beneficiaries.

VISN 2 South has a follow-on requirement to provide a full range of Prognostics, Molecular Diagnostics, and Therapeutic referral laboratory services to VISN 2 South Medical Centers. Basic services shall include the transportation of clinical laboratory specimens to the Contractor’s laboratory(s), performance of analytical testing as defined by the Contractor’s reference test manual, reporting of analytical test results, and consultative services as required to provide the full scope of its laboratory operations for VISN 2 South. The contractor shall provide 24/7 secure access to a web-based online support system that includes both interactive customer service and a user-friendly help module.

The Contractor shall provide routine scheduled courier services every day excluding weekends and Federal holidays between VISN 2 South facilities and contracted laboratory. At times during the period of performance, there will be a requirement to provide week-end, urgent, and/or Holiday specimen pick-up should be arranged between the facility and the Contractor. Courier services shall be automatically extended to all new VISN 2 South facilities acquired during the contract period. Service will include at least one (1) pick-up per day at each VISN 2 South facility. The times of this pick up will be determined by the VA and the contractor will be responsible for adhering to a schedule provided by the point of contacts at the various sites.

Contractor’s name:________________________________

1. PURPOSE

This over (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 Administrative CO: Janice Brooks Campbell

Organization or Agency: Department of Veterans Affairs, - VISN 2

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:

1.

c. Other Key Government Personnel 1.

4. Performance Standards

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The performance requirements are contained in the Performance Work Statement (PWS). The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

The Incentive for all is Favorable contractor performance evaluation.

5. INCENTIVES

The Government shall use past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting 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. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

1, 4, and 5

b. PERIODIC INSPECTION. (Evaluates outcomes on a periodic basis. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.)

1, 2, and 3

c. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.)

5 and 4

7. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

a. ACCEPTABLE AND NOT ACCEPTABLE

8. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

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 COR. The Government shall review the contractor's corrective action plan to determine acceptability.

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.

During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR shall meet with the contractor <state how often performance assessment will be conducted> to assess performance and shall provide a written assessment.

Signature – Contractor Program Manager

Signature – Contracting Officer’s Representative