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 Greater Los Angeles Healthcare Medical Center (GLA) laboratories requires a yearly requirement to be accredited by The Joint Commission. As part of this requirement, GLA laboratory must comply with requirements for periodic calibration and calibration verification of its testing instrumentation. GLA 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 Greater Los Angeles Healthcare Medical Center 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.

Item List:

Item #

Description/Part Number*

Product Number

Qty

1

LN2BV

CHEM CVL BECKMAN (EXCEPT AU), VITROS

1

2

CAPBIND

CAP GENERIC SURVEY BINDER

1

3

FH9Q

QUALITY CROSS CHECK-HEMATOLOGY

1

4

LN13

BLOOD GAS CVL

1

5

LN2BV

CHEM CVL BECKMAN (EXCEPT AU), VITROS

2

6

LN7

IMMUNOLOGY CVL

1

7

LN9

HEMATOLOGY CVL

2

8

CAPBIND

CAP GENERIC SURVEY BINDER

1

9

AQQ

QUALITY CROSS CHECK-BLOOD GAS

1

10

BNPQ

QUALITY CROSS CHECK-BNP

1

11

CGLQ

QUALITY CROSS CHECK-COAGULATION

1

12

CMQ

QUALITY CROSS CHECK-URINALYSIS

1

13

CRTQ

CARDIAC MARKERS QUALITY CROSS CHECK

1

14

CZQ

QUALITY CROSS CHECK-CHEM/TDM

1

15

FH9Q

QUALITY CROSS CHECK-HEMATOLOGY

1

16

FLDQ

QUALITY CROSS CHECK-BODY FLUID CHEMISTRY

1

17

GHQ

QUALITY CROSS CHECK-HEMOGLOBIN A1C

1

18

HCRQ

QCC-HIGH SENSITIVITY CARDIAC MARKERS

1

19

LN13

BLOOD GAS CVL

3

20

LN13C

BLOOD GAS/CRITICAL CARE CVL

3

21

LN15

HEMOGLOBIN A1C ACCURACY CVL

2

22

LN16

HOMOCYSTEINE CVL

1

23

LN2

Chemistry/Lipid/Enzyme CVL

2

24

LN23

PROSTATE-SPECIFIC ANTIGEN CVL

2

25

LN30

B-TYPE NATRIURETIC PEPTIDE CVL

2

26

LN36

HEPARIN CVL

2

27

LN40

VITAMIN D CVL

2

28

LN42

D-DIMER CVL

2

29

LN44

FIBRINOGEN CVL

2

30

LN48

HIGH-SENSITIVITY TROPONIN I CVL

2

31

LN5

LIGAND ASSAY CVL

2

32

LN50

THYROID PANEL CVL

4

33

LN5S

LIGAND ASSAY, SIEMENS CVL

2

34

LN8

REPRODUCTIVE ENDOCRINOLOGY CVL

2

35

LPX

LABORATORY PREPAREDNESS EXERCISE

1

36

MBT

MICRO BENCH TOOLS COMPETENCY

2

37

NGC

NON-GYN INTERLABORATORY COMPARISON, LAB

1

38

NGC1

NON-GYN INTERLABORATORY COMPARISON, INDV

7

39

PTHQ

QUALITY CROSS CHECK-PARATHYROID HORMONE

1

40

SOQ

QUALITY CROSS CHECK-BLOOD OXIMETRY

1

41

TMCA

TRANSF MED COMPREHENSIVE-COMP ASSESS

1

42

TMCAD

DIRECT ANTIGLOBULIN TEST-COMP ASSESSMENT

1

43

TMCAE

ELUATE COMPETENCY ASSESSMENT

1

44

VGS1

VIRTUAL GRAM STAIN BASIC COMPETENCY

2

45

CAPBIND

CAP GENERIC SURVEY BINDER

9

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 Joanne Woo at joanne.woo@va.gov with the following information referenced in the subject line, 36C26225Q0204. 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 Standard Time (PST) on December 10th, 2024 to Joanne Woo at joanne.woo@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