ATTACHMENT D - QASP - VISN1 Primary Reference Lab 5yr.doc

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Primary Reference Laboratory Services VISN 1
Solicitation number
36C24125Q0414_1
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This is a Quality Assurance Surveillance Plan (QASP) for Reference Laboratory Services under a Department of Veterans Affairs contract for Veterans Integrated Service Network (VISN) 1. The QASP establishes systematic methods to evaluate contractor performance for primary reference laboratory testing services, specimen collection, processing, and transportation at Patient Service Centers for Community Based Outpatient Clinics (CBOCs). The plan defines seven key performance standards with specific acceptable quality levels: written consultative reports must be provided for 100% of cases; reports must include appropriate specimen identification information at 98% compliance; accreditations and certifications must be maintained at 100%; specimen loss or destruction must not exceed 2% (98% integrity); delivery times must be met 95% of the time; turnaround time for tests must meet established schedules at 95% compliance; and patient identification using two identifiers must be achieved at 100%. The Contracting Officer, Contracting Officer's Representative (COR), and key government personnel from the New England Network Consolidated Laboratory are identified as responsible for surveillance activities. Performance monitoring will utilize periodic inspections, random sampling, and contractor reporting, with results documented on Quality Assurance Worksheets submitted to the Contracting Officer within 30 days of contract expiration. The incentive mechanism is the potential exercise of option periods based on whether the contractor exceeds, meets, or does not meet established standards, with performance rated on a three-tier system using Green (meets AQL), Yellow (meets minimum AQL with attention needed), and Red (does not meet AQL) ratings.

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36C24125Q0414_1.pdf PDF
ATTACHMENT B- Facility Locations and Contacts 5yr.xlsx XLSX spreadsheet
ATTACHMENT C- Other Services 5 yr.xlsx XLSX spreadsheet
ATTACHMENT A- Test Menu 5 years.xlsx XLSX spreadsheet

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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
1
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
2
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 Period
Quality Care
4
Ensure Safety, Security, and Integrity of Specimens
No loss or destruction of specimens
98%
Contractor reporting/VA reporting
Potential Exercise of Option Period
Quality Care
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
95%
Periodic Inspections and random sampling
Potential Exercise of Option Period
Quality Care
7
Ensures patients are identified and patient specimens are labeled correctly (PSC)
All patients will be actively identified using 2 appropriate identifiers/Identification & match of patient to specimen label
100%
Contractor/VA reporting
Potential Exercise of Option Period

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)

Green
Comments Unnecessary for “Green” QA Rating.

Yellow

Red

Quality Care (Task #3)

Green
Comments Unnecessary for “Green” QA Rating.

Yellow

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.

Yellow

Red

Quality Care

(Task #7)

Green
Comments Unnecessary for “Green” QA Rating.

Yellow

Red

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

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