ATTACHMENT D - QASP - VISN1 Primary Reference Lab 4.24.25.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN

For: Reference Laboratory Services Contract Number:

Contract Description: VISN1 Primary Reference Laboratory Testing Services, IntraVISN transportation and specimen collection and processing at Patient Service Centers for CBOC’s.

Contractor’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:

Organization or Agency: Department of Veterans Affairs, VISN 1 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:

Organization or Agency:

c. Key Government Personnel - Wendy Strollo, Program Director, New England Network Consolidated Laboratory Jacqueline Dang, 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 Jean McElreavy, Program Support Assistant, 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.>

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 Summary Matrix, paragraph 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).

Task

ID Indicator Standard Acceptable

Quality Level

Method of Surveillance Incentive

Clinical Information Return

Written Consultative reports provided to the authorizing VA Medical Center

Report received for each consultative case.

100%

Periodic inspection and random sampling

Potential Exercise of Option Period

Clinical Information Return

Written Consultative Reports include laboratory’s name & address that performed the consultation, laboratory specific accession number, date and time specimen was collected, date received by the laboratory and completed by the laboratory; and the pathologist’s and/or signature where appropriate

Reports include appropriate specimen identification information

98%

Periodic inspection and random sampling

Potential Exercise of Option Period

Quality Care

3 Licensing and

Accreditation

Maintains accreditation, certifications, etc. as outlined in the PWS

100% Periodic inspection

Potential Exercise of Option

Task

ID Indicator Standard Acceptable

Quality Level

Method of Surveillance Incentive

4 Ensure Safety, Security, and Integrity of Specimens

No loss or destruction of specimens

98% Contractor reporting/VA reporting

Potential Exercise of Option

5 Ensure Safety, Security, and timely delivery/pickup Delivery times are met

95% Contractor reporting/VA reporting

Potential Exercise of Option Period

Turnaround Time

6 Actual turnaround time per test

Maintains the time schedule for stats and routine tests as outlined in the contractor electronic reference guide

98% Periodic Inspections and random sampling

Potential Exercise of Option

7 Ensures patients are identified and patient specimens are labeled correctly (PSC)

All patients will be actively identified using 2 appropriate identifiers/Identificati on & match of patient to specimen label

100% Contractor/VA reporting

Potential Exercise of Option

5. INCENTIVES

The Government shall use “Potential Exercise of Option Period” as an incentive. 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. 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 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:

Rating Description

Green Yes. Performance and technical specifications are being met at an Acceptable Quality Level (AQL).

Yellow

Yes. Performance and technical specifications are currently being met at the minimum AQL, but the following service/deliverable needs contractor attention:

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

Red No. Performance and technical specifications are not being met at AQL and the following service/deliverable needs immediate contractor resolution:

QUALITY ASSURANCE WORKSHEET

Performance Rating Deliverable/Service Quality

Rating Causative

Factors Effect on Mission Action

Required/Date

Clinical Information Return (Task #1)

Green Comments Unnecessary for “Green” QA Rating.

Yellow

Red

Clinical Information Return (Task #2)

Red

Quality Care (Task #3)

Red

Quality Care (Task #4)

Green Comments Unnecessary for “Green” QA Rating.

Yellow

Red

Quality Care (Task #5)

Green Comments Unnecessary for “Green” QA Rating.

Yellow

Red

Turnaround Time (Task #6)

Green Comments Unnecessary for “Green” QA Rating.

(Task #7)

Green Comments Unnecessary for “Green” QA Rating.

8. DOCUMENTING PERFORMANCE

The COR shall maintain the Quality Assurance Worksheets in contract file and submit 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.

<After award, both the contractor’s Program Manager and the COR shall sign this document.>

Signature – Contractor Program Manager

Signature – Contracting Officer’s Representative