New - CAP - One Year Requirement

Special Notice – Notice of Intent to Award a Sole Source Procurement

The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 17, intends to award a firm-fixed priced contract to The College of American Pathologists for procurement of the following requirement:

Purpose

All VHA Pathology and Laboratory Medicine Service (P&LMS) laboratories and Ancillary Testing Sites that perform patient testing, regardless of complexity, must subscribe to an external proficiency testing program that meets the Clinical Laboratory Improvement Act 1988 (CLIA ’88) and its amendments; to ensure reliability of patient testing and meet accreditation requirements. 

Many testing systems within P&LMS also require validation of the Analytical Measurement Range (AMR) for an analyte both initially and at least every six months thereafter.  This can be accomplished through purchase of linearity material that is both matrix specific and spans the range of the AMR for each analyte, when required. This is addressed in 42 CFR 493.1255 (b) and the College of American Pathologists (CAP) standard CHM.13600.

This Statement of Work (SOW) is requesting the procurement of proficiency and linearity materials that are not provided through the P&LMS VA Central Office (VACO); but are still required by the guidelines set forth in VA Handbook 1106, 42 CFR 493 Subpart H and K, and many CAP standards.  Therefore, procurement of the materials described above is not an option, but a requirement of accreditation for all VA laboratories.

Scope

The overall purpose of this requirement is to obtain a vendor to provide CLIA ’88 approved proficiency testing and linearity materials, which are not already provided through P&LMS VACO funding.  This will ensure that all laboratories and ancillary testing sites that perform patient testing, within the Veterans Administration North Texas Health Care System (VANTHCS), follow VHA Handbook 1106, 42 CFR 493 Subpart H & K requirements, and CAP accreditation standards.  For this award, the proficiency testing program must be approved for the following CLIA specialties: Anatomic Pathology, Microbiology, Diagnostic and General Immunology, and Routine and Special Chemistry.

Location

The proficiency and linearity materials will be utilized for compliance testing in the P&LMS Department of the VANTHCS System, including: the Dallas VAMC, Sam Rayburn Memorial Medical Center (Bonham, TX), and Fort Worth VA Outpatient Clinic.

Period of Performance

The Contract period of performance shall be January 01, 2027, through December 31, 2027.  

Type of Contract

NCO 17 and VANTHCS intends to award a contract to the vendor who can supply the following for the Beckman DxC 700 AU (Bonham), Beckman DxI 9000 Access (Bonham, Fort Worth and Dallas), Beckman Coulter AU 5822 (Dallas), TOSOH A1c G8 (Bonham, Fort Worth, and Dallas) and Abbott Alinity I (Dallas) during the contract period:

• General Chemistry/Lipid/Enzyme Linearity material for plasma/serum Albumin, Calcium, Chloride, CO2, Creatinine, Glucose, Iron, Magnesium, Osmolality, Phosphorous, Potassium, Total Protein, Sodium, BUN, Uric Acid, Alkaline Phos, ALT (GPT), Amylase, AST (SGOT), CK, CKMB, GGT, LDH, Lipase, Total and Direct Bilirubin, Cholesterol, HDL, and Triglycerides linearity/calibration verification (4 surveys per year).
• Therapeutic Drug Linearity material for plasma/serum Lithium (2 surveys per year).
• Urine Chemistry Linearity material for Calcium, Chloride, Creatinine, Glucose, Osmolality, Phosphorus, Potassium, Total Protein, Sodium, Urea Nitrogen, Uric Acid (2 surveys per year).
• Linearity material to monitor test: Ammonia (4 surveys per year).
• Linearity material to monitor test: Serum Ethanol (3 surveys per year).
• Linearity material for molecular diagnostics tests: HBV, HCV, and HIV Viral Loads (1 survey for each Viral Load per year).
• Linearity material to monitor test: Hemoglobin A1C (3 surveys per year).

Vendor will also provide the following proficiency testing (PT) surveys, calibration/linearity, and competency assessment materials for the following:

• Instrumentation calibration/linearity verification materials including Gravimetric pipette calibration, Microtiter plate linearity, Refractometer calibration, Spectrophotometer stray light check, fluorescent intensity check, and pH meter check.
• Interlaboratory Comparison Non-GYN Cytology PT surveys for nine (9) pathologists and one (1) cytotechnologist. (2 surveys per year).
• Laboratory Preparedness check for Microbiology section to ensure the laboratory is ready for handling of dangerous organisms (1 survey per year).
• Eluate competency assessment for Transfusion Medicine section (2 surveys per year).
• Miscellaneous survey replacement samples are required as needed in the case of instrument malfunction during processing or technical exception. 

Tasks

Task 1:  Proficiency Testing and Linearity program

• The contractor must be on the CMS list of CLIA-approved proficiency testing providers for Chemistry, Diagnostic Immunology, Immunoglobulins, Microbiology/Bacteriology, Urinalysis, and Cytology.
• The contractor’s program must be a CLIA approved proficiency testing program that supplies both proficiency testing and linearity materials.
• The proficiency testing/linearity program must:
•  Provide at a minimum the following specimens or materials within the VANTHCS System: 

• General Chemistry Linearity materials for both plasma/serum that include all listed analytes to be shipped to Dallas VAMC (2), FWOPC (1), and Bonham (1) approximately every six months. 
• Therapeutic Drug Linearity materials for Lithium (2 shipments approximately every six months to Dallas VAMC). 
• Urine Chemistry Linearity materials (2 shipments approximately every six months to Dallas VAMC). 
• Ammonia Linearity materials shipped to Dallas VAMC (2), Bonham (1), and FWOP (1) approximately every six months. 
• Serum Ethanol Linearity materials shipped to Dallas VAMC (2) and Bonham (1) approximately every six months.
• HBV, HCV and HIV Viral Load Linearity materials shipped to Dallas VAMC (1 of each Viral Load noted) approximately every six months.
• Hemoglobin A1C Linearity material to monitor A1C test shipped to Dallas VAMC (2) FWOPC (1), and Bonham (1) approximately every six months.
• Instrumentation Linearity materials shipped to Dallas VAMC approximately every six months. 
• Interlaboratory Comparison Non-GYN Cytology PT surveys for nine (9) pathologists and one (1) cytotechnologist shipped to Dallas VAMC approximately every six months. 
• Laboratory Preparedness Survey materials shipped to Dallas VAMC (1) approximately every six months. 
• Eluate competency assessment materials shipped to Dallas VAMC (2) approximately every six months.
• Include a mechanism for the contractor to notify the following in the VANTHCS System: VANTHCS Contract Officer Representative (COR), VANTHCS Laboratory Manager, VANTHCS Quality Medical Technologist (QMT), and each individual laboratory point of contact (POC) of any PT/linearity updates.
• Include a contractor established event calendar and/or shipping table that identifies the date each PT/linearity is scheduled to be shipped to the laboratory.
• The contractor is to ensure that PT/linearity materials are shipped at the proper temperature to ensure viability of specimens when they arrive at the testing laboratory.
• Have a mechanism that allows each individual laboratory to transmit PT/linearity results electronically via a secure website or by facsimile.

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

• A mechanism for each laboratory to compare its PT performance or results against peer laboratories using the same method (when applicable).
• A summary of the individual laboratory’s historic performance over the past three PT events.
• Overall performance indicates whether current performance is satisfactory, at risk pending future performance, or unsatisfactory.
• A summary of peer participant results (when applicable).
• The reason any proficiency testing result was not scored or graded.
• Provide the VANTHCS Laboratory Manager, VANTHCS Quality Medical Technologist (QMT), individual laboratory’s point of contact (POC), the National Compliance Officer, and the laboratory’s accrediting organization. 
•  Documentation of PT/linearity formal evaluations.
• Written notification when PT results are not received by the contractor, when analyte performance is scored as unacceptable, and when analyte overall performance is assessed as unsatisfactory.
• Provide a plan for replacement of defective or damaged PT/linearity materials.
• Provide a glossary of terms when technical terminology is used in a PT survey or calibration/linearity verification kit.
• Have an electronic method (i.e., website, fax, email) for receipt of VA furnished correspondence.  Contract prices should include any costs associated with the electronic data transmission.

Task 2: Deliverables: Mailed, Written Correspondence, and Database Files

1. All Mailed deliverables, which includes PT/linearity materials shall be shipped Freight on Board (FOB) Destination (paid by contractor) and shipped directly to the performing laboratory.
2. Written correspondence may be shipped FOB Destination (paid by the contractor) or delivered electronically to the COR, QMT, laboratory POC, VA National Compliance Officer, and accrediting agency.  The electronic format must mirror the contents of a paper format.  Written or electronic correspondence must be sent for the following:
   • PT/linearity updates will be provided within 10 working days of a change.
   • PT/linearity manuals, catalogs, and event calendars (with shipping tables) will be made available to all above parties within 10 working days of the award for base and each option year.
   • PT/linearity formal evaluation reports will be made available to all above parties within 30 calendar days of the evaluation.
3. Database files (i.e., XML, Excel, HTML) shall be submitted to the COR, QMT, and laboratory POCs electronically.
   • PT/linearity ordering, shipping, pricing information (to include updates/changes), and cut-off dates shall be provided to the COR, QMT, and laboratory POC within 10 working days.
   • Summary/Confirmation of all order changes and a running balance report shall be provided monthly (30 calendar days) to the COR, QMT, and laboratory POC.
   • The contractor shall provide PT/linearity performance data in both a paper format and XML format through a secured FTP server connection.
4. The contractor shall submit any required documentation to the laboratory’s accrediting organization using a format that is routinely accepted by the accrediting organization.                              

Anticipated Period of Performance: January 1, 2027, through December 31, 2027.

The proposed sole source procurement will be made by an open market pricing agreement with The College of American Pathologists.         

The requesting activity has submitted a sole source justification request that states that vendor The College of American Pathologists is the only vendor that can provide the necessary supplies.  Market research did not find an alternate approved vendor that can provide all the required supplies.

This notice is not to be considered a request for quotations or proposals. No contract will be awarded based on offers received in response to this notice; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.  Proposals or offers received will be used to determine if a comparable source is available and more advantageous to the government.  If no affirmative written response is received within 7 calendar days from the publication of this notice, a contract will be issued to The College of American Pathologists without any further notice.

The anticipated statutory authority permitting other than full and open competition for the requirement is 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.