Statement of Work.pdf

Statement of Work

A. Background

As required by VHA Handbook 1106.01,

1. All Department of Veterans Affairs (VA)’s Pathology and Laboratory Medicine Service laboratories that perform testing on patients must subscribe to an external proficiency testing program that meets Clinical Laboratory Improvement Act 1988 and amendments (CLIA)1988 requirements to:

a) Ensure reliability of patient testing in the laboratory, and

b) Meet accreditation requirements

2. All laboratories must successfully participate in a Centers for Medicare and Medicaid Services

(CMS)- Clinical Laboratory Improvement Amendments (CLIA) approved PT program.

3. External Proficiency Testing (PT) Program: As an enhancement to the internal Quality

Control Program, to ensure reliability of patient testing in the laboratory, and to maintain accreditation requirements, each Pathology and Laboratory Medicine Service and all Ancillary

Testing Sites must subscribe to external PT programs that meet CLIA’88 requirements for all analytes for which PT is available, including waived testing, Provider Performed Microscopy

(PPM), and unregulated analytes.

4. Laboratories that perform clinical diagnostic tests on human specimens and fail to meet the PT requirements as described in 42 CFR 493, Subpart H, or who have demonstrated deficiencies which pose a direct threat to patients may be instructed to terminate those processes.

CMS has determined the analyte-specific evaluation criteria and target values used to grade proficiency testing results for regulated analyte. CLIA approved proficiency testing providers may specify grading criteria for other-than-regulated analytes.

CLIA categorization is determined after the FDA has cleared or approved a marketing submission. The FDA determines the test’s complexity by reviewing the package insert test instructions, and using a criteria “scorecard” to categorize a test as moderate or high

Complexity.

B. Scope

The overall purpose of this requirement is to obtain a contractor to provide a CLIA ‘88 approved proficiency testing program so that all VHA medical laboratories and ancillary testing sites that perform patient testing are following VHA Handbook 1106.01 proficiency testing requirements.

C. Period of Performance

The anticipated contract period of performance shall be March 20, 2026, to March 19, 2027.

Place of performance is the John D. Dingell VA Hospital laboratory, Detroit, MI.

D. Tasks

Task 1: Implement a Proficiency Testing program

1. The contractor’s program must be a CLIA approved proficiency testing program.

The proficiency testing program must:

i. Be administered as specified in package submitted for CLIA proficiency testing program approval.

ii. Provide, at minimum, specimens for all Calibration Verification / Linearity

Evaluation (CVL) analytes.

iii. Include a mechanism for the contractor to notify the government if proficiency testing updates become available and promptly notify each proficiency testing laboratory and COR, in writing (mailed or electronic), of such updates.

iv. Include a contractor established event calendar and/or shipping table that identifies the date each proficiency testing deliverable is scheduled to be shipped to the testing laboratory.

v. Have a method that allows each individual laboratory to transmit proficiency testing results electronically (i.e., secured website, secure direct interface capability, facsimile, etc).

vi. Meet, or be more restrictive than, evaluation criteria (allowable limits and target values) determined by CMS for each regulated analyte. For other-than-regulated analytes, the grading criteria may be determined by the contractor.

vii. Include formal evaluation of results for each test. Formal evaluations reports must include:

a) A mechanism for each laboratory to compare its proficiency testing performance and/or results against peer laboratories using the same instrument/reagent system

(when available)

b) A summary of the individual laboratory’s historic performance over the past three proficiency testing events for each regulated analyte

c) Overall performance summary report for each regulated analyte that indicates whether current performance is satisfactory, at risk pending future performance, or unsatisfactory.

d) A summary of peer participant results

e) As applicable for each analyte: analyte tested, test methodology, reported results, graded score, peer statistics (such as mean standard deviation) and contractor determined intended result.

f) The reason any proficiency testing result was not scored/graded

Oblige the contractor to provide the proficiency testing laboratory’s POC, the respective Regional Medical Technologist, and the laboratory’s accrediting organization:

a) Documentation of proficiency testing formal evaluations

b) Written notification when proficiency testing results are not received by contractor

c) Written notification when analyte performance is scored as unacceptable

d) Written notification when analyte overall performance is assessed as unsatisfactory

ix. Provide a plan for replacement of defective or damaged deliverable (proficiency testing material/supplies)

x. Provide a glossary of terms if technical terminology is used. Otherwise, information must be phrased in audience appropriate language.

xi. Have an electronic method (ie., website, fax, email) for receipt of VA furnished correspondence (i.e., proficiency testing results, VA facility demographics) that is required for the proficiency testing program. Contract prices should include any costs associated with electronic data transmission.

Task 2: Deliverables: Mailed, & Written Correspondence

1. All Mailed deliverables, which includes proficiency testing material/supplies shall be shipped

Freight On Board (FOB) Destination (paid by contractor).

i. Proficiency Testing specimens/materials shall be delivered to the John D. Dingell VA

Laboratory, Detroit, MI.

2. Written correspondence may be shipped FOB Destination (paid by contractor) or delivered electronically (PDF, Word, Excel, or other mutual agreement between COR and Contractor) to respective VHA clinical laboratory POC and/or VA Regional Technologist (as provided by individual laboratories post award). Electronic format must mirror contents of paper format.

i. Proficiency Testing updates shall be provided to all VHA clinical laboratory POCs, VA

Regional Technologists, and the COR within 10 working days of change.

ii. Proficiency Testing Manuals, Proficiency Testing Catalogs, and Proficiency Testing event calendars and/or shipping tables shall be made available.

iii. Formal evaluation reports and other proficiency testing notifications shall be made available to the John D. Dingell clinical laboratory POC, the respective VA Regional

Technologist, and the laboratory’s accrediting organization within 30 calendar days of evaluation.

E. Government Furnished Items

Contract prices should include any costs associated with electronic data transmission.

1. The John D. Dingell VA clinical laboratory will provide proficiency testing results to the contractor via electronic method(s) determined by contractor

2. The John D. Dingell VA clinical laboratory will provide its respective POC and other demographics using forms provided by contractor

F. Contractor Experience Requirements

The contractor must be on CMS list of CLIA-approved proficiency testing providers for the following specialties, Calibration Verification / Linearity Evaluation (CVL) analytes to include

Chemistry and Flow Cytometry.

G. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.