Attachment B - QASP - Sendout Laboratory Semen Analysis.doc

Quality Assurance Surveillance Plan

For: Laboratory Services Contract Number: [Enter Contract#] Contract Description: Check One:

[ ] VISN1 Primary Reference Laboratory Services, intraVISN transportation and specimen collection and processing at Patient Service Centers for CBOC’s.

[ X ] VISN1 Reference Laboratory Services Only Contractor’s name: [Enter Vendor’s Name]

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: [Enter Name of Assigned CO] Organization or Agency: Department of Veterans Affairs, VISN1 Consolidated Contracting

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’s: [Enter name(s) of CORs]

c. Key Government Personnel -

· Wendy Strollo, NCL Program Director, New England Network Consolidated Laboratory

· Jacqueline Dang, NCL Quality Manager, New England Network Consolidated Laboratory

· Holly Charpentier, Program Support Medical Technologist, New England Network Consolidated Laboratory

· Jacqueline Hite, Program Support Medical Technologist, New England Network Consolidated Laboratory

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

a. Program Manager – [Enter name(s) of Contractor personnel]

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

The Performance Requirements Summary Matrix table as provided below includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Quality Care

5. Incentives The Government shall use “Potential Exercise of Option Period” as an incentive. Incentives shall be based on meeting, exceeding 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. PERIODIC INSPECTION. (Evaluates outcomes on a periodic basis. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or Annually] or unscheduled, as required.)

Performance standard(s) IDs 1, 2, 3 and 5.

b. RANDOM SAMPLING. (Designed to evaluate performance by randomly selecting and inspecting a sample of cases.

Performance standard(s) IDs 1,2 and 5.

c. CONTRACTING REPORTING. (Self-reported by the contractor or VA) Performance standard(s) ID 4 and 6

7. Ratings Metrics and methods are designed to determine if performance meets, exceeds 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:

Quality Level (AQL).

(The Customer must identify what component of the deliverable and/or service requires attention.)

(The Customer must identify what component of the deliverable and/or service requires attention.)

QUALITY ASSURANCE WORKSHEET

Performance Rating

Clinical Information Return (Task #1)

Yellow

Red

Clinical Information Return (Task #2)

Yellow

Red

Quality Care (Task #3)

Yellow

Red

Quality Care

(Task #4)

Yellow

Red

Turnaround Time

(Task #5)

Yellow

Red

Quality Care

(Task #6)

Yellow

Red

8. DOCUMENTING PERFORMANCE

The COR shall maintain the Quality Assurance Worksheets in a contract file and submit this at end of the contract period to the Contracting Officer. These worksheets shall be submitted no later than 30 days after contract expiration.

9. Frequency of Measurement

The COR shall assess contract performance on a periodic basis using the Quality Assurance Worksheet.

Signature/Date – Contractor Program Manager

Signature/Date – Contracting Officer’s Representative