H166--Intent to Sole Source - College of American Pathologists

The Department of Veterans Affairs, Network Contracting Office (NCO) 22, located at 4811 Airport Plaza Drive, Long Beach, CA 90815 is issuing this Notice of Intent (NOI) to inform industry contractors of the Government s intent to execute a Sole Source Award under FAR Part 13 Simplified Acquisition Procedures (SAP), specifically FAR Subpart 13.5 Simplified Procedures for Certain Commercial Products and Commercial Services.

The intended Contractor is College of American Pathologist located at 325 Waukegan Road, Northfield, IL 60093.

The New Mexico VA Healthcare System (NMVAHCS) laboratories require a yearly requirement to be accredited by The Joint Commission. As part of this requirement, NMVAHCS laboratory must comply with requirements for periodic calibration and calibration verification of its testing instrumentation. NMVAHCS must also perform calibration verification and linearity and analytical measurement range verification of the test results. The surveys being requested for purchase from the College of American Pathologists (CAP) provide suitable materials for this purpose, as well as assessment of results using well-defined evaluation protocols.

The rationale basis for the sole source acquisition is that CAP (Large Business) is the only Clinical Laboratory Improvement Amendments (CLIA) and Food and Drug Administration (FDA) approved responsible source that can provide the original equipment manufacturer (OEM) for the Calibration Verification/Linearity Instrumentation Programs that meets the linearity testing guidelines established to ensure compliant with CLIA federal guidelines and to ensure the Lab s testing procedures are consistent with established FDA, CLIA, and VHA regulations.

CAP is the sole source manufacturer and distributor of CAP validation and linearity instrumentation materials currently being used by the NMVAHCS Laboratory to satisfy their requirements for scheduled calibration verification and verification of the analytical measurement range as specified in the current CLIA licensing requirements and The Joint Commission (TJC) Laboratory accreditation requirements under 42 CFR 493.1255(bX3), as well to satisfy requirements to maintain their current CLIA accreditation. CAP sells directly to the end users facilities and as such, there are no agents or dealers authorized to represent this product.

Period of performance: Base year + 4 optional years

Item List:

Line Item

Manufacturer Part Number

Brand Name Nomenclature

1

LN13C

BLOOD GAS/CRITICAL CARE CVL

2

LN15

HEMOGLOBIN A1C ACCURACY CVL

3

LN2BV

CHEM CVL BECKMAN (EXCEPT AU), VITROS

4

LN40

VITAMIN D CVL

5

LN41

PROCALCITONIN CVL

6

LN5

LIGAN ASSAY CVL

7

LN6

URINE CHEMISTRY CVL

8

LN8

REPRODUCTIVE ENDOCRINOLOGY CVL

9

NGC

NON-GYN INTERLABORATORY COMPARISON, LAB

10

NGC1

NON-GYN INTERLABORATORY COMPARISON, INDV

This procurement is being conducted using commercial products and commercial services procedures pursuant to FAR Part 12 and FAR Part 13, specifically FAR Subpart13.106-1(b)(1)(i) allowing the Contracting Officer (CO) to solicit from one source.

The North American Industry Classification System (NAICS) for this requirement is, 541380 Testing Laboratories. Product of Service Code for this requirement is H166 Quality Control Instruments and Laboratory Equipment. The Small Business Administration (SBA) size standard for this sector is $19.0 Million.

This notice of intent is neither a formal solicitation nor a request for competitive proposals. No solicitation document is available and telephone requests will not be honored. No award will be made on the basis of unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling and convincing evidence that competition will be advantageous to the Government. The intent of this synopsis is for informational purposes only. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this action based on this notice is solely within the discretion of the Government.

All inquiries and concerns must be addressed in writing via e-mail to Clift Domen at Clift.Domen@va.gov with the following information referenced in the subject line, 36C26226Q0015. A determination by the Government not to compete this proposed procurement based on the responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All interested parties who are responsible, certified, and capable may identify their interest and may submit capability statement which shall be considered by the agency no later than 10:00 AM Pacific Daylight Savings Time (PDT) on Tuesday September 2nd, 2025 to Clift Domen at Clift.Domen@va.gov. The interested parties bear full responsibility to ensure complete transmission and timely receipt.

SDVOSB/VOSB respondents.

If respondent is or SDVOSB or VOSB, respondent is encouraged to provide proof of VetCert certification. In addition, SDVOSB/VOSB Contractors are asked to acknowledge that they understand the limitations on sub-contracting pursuant to FAR 52.219-14, Limitations on Sub-Contracting, which will be included in the impending solicitation. Further SDVOSB/VOSB contractors are asked to respond that they are capable of providing the requested services keeping within the parameters of this clause.

Please provide the information below:

Company Name:

UEI Number:

Address:

Point of Contact Name:

Phone No:

Email:

Business size information

Select all that applies:

o Small Business

o Emerging Small Business

o Small Disadvantaged Business

o Certified under Section 8(a) of the Small Business Act

o HubZone

o Woman Owned

o Certified Service-Disabled Veteran Owned Small Business (registered in VetBiz.gov)

o Veteran Owned Small Business (registered in VetBiz.gov)

FSS/ GSA Contract Holder

Yes No

FSS/ GSA Contract Number

Effective Date / Expiration Date

NASA SEWP Contract Holder

Yes No

NASA SEWP Contract Number

Effective Date / Expiration Date