6640--Supply: Coagulation Testing

Pre-Solicitation

This is a Pre-Solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. THIS PRE-SOLICITATION NOTICE IS NOT A REQUEST FOR A QUOTE (RFQ). VENDORS SHOULD NOT SUBMIT FORMAL QUOTES UNTIL THE RFQ IS POSTED ON THIS WEBSITE. This notice is not to be construed as a commitment by the Government nor will the Government pay for the information resulting from this posting.

The Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN 8), James A. Haley Veterans Hospital (JAHVH), Tampa, FL, intends to issue a Request for Quote (RFQ), brand name or equal to WerFen instrumentation Laboratory ACL TOPs), including service & maintenance, supplies/consumables included in the price of reagents. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 334516-Analytical Laboratory Instrument Manufacturing with 1000 employees.

See below specifications: Brand name or equal.

EQUIPMENT:

The Contractor shall provide four (4) name brand (Instrumentation Laboratory ACL TOPSs) or equivalent Coagulation analyzers that FDA-approved, fully automated, and integrated analyzer testing systems, printers, computers, uninterruptable power supplies (UPS) for all analyzers, and accessories required for equipment usage.

Below are the salient characteristics of the FDA-approved, fully automated, and integrated analyzer testing systems, printers, computers, uninterruptable power supplies (UPS) for all analyzers, and accessories required for equipment usage. The proposal shall provide descriptive literature that meets the following specifications for the testing systems and assay requirements:

General instrument characteristics include the ability to run FDA-approved patient testing for PT, PTT, INR, Fibrinogen, D-dimer, Lupus Panel, Heparin anti-Xa (generic for all types of heparin), HIT, and Ristocetin, Factor Assays and special coagulation testing to including but not limited to mixing studies.

Coagulation Analyzers: (Locations: JAHVH, JAH New Port Richey VA Outpatient Clinic, and JAH Lakeland VA Outpatient Clinic).

General instrument characteristics include continuous operation including continuous sample and reagent loading without interruption of testing in progress.

Instrument systems include integrated data management system, external printer, and UPS.

All systems must utilize the same operating system and user interface.

Instruments must offer extensive test menus capable of performing assays for screening, monitoring, and diagnosis of bleeding and thrombotic risks.

Instruments must have STAT processing capabilities without disrupting other testing in progress.

Instrument must include integrated sample and reagent barcode readers capable of reading multiple barcode symbologies.

Instrument should be capable of performing preanalytical testing to detect tube-fill height issues, flag abnormal sample aspiration due to the presence of clots, as well as detecting interference for hemolysis, lipemia, and bilirubin.

Data management capability for the purpose of checking QC, calibration, and other quality control options.

Physical Characteristics include NTE 350 pounds and 60 x 32 x 30 . Must be free standing or include instrument cart.

Electrical Characteristics - 120 V.

NAME BRAND: WerFen (Instrumentation Laboratory ACL TOPs) OR EQUIVALENT Functionality and Performance Specifications:

The systems (delete should ) be barcode driven, random access, with continuous loading and unloading of samples, reagents, and consumables.

The systems (delete should ) be flexible, with a minimum throughput of 240 tests per hour for the JAHVH site and 100 tests per hour at other sites.

The systems (delete should )provide clotting, chromogenic, and turbidimetric testing capabilities to run a complete menu of routine and specialty coagulation assays including, but not limited to, Antithrombin, Protein C & S, Plasminogen, von Willebrand assays, Lupus Anticoagulant assays, Factor V Leiden screening, Heparin Xa, D-Dimer, HIT, and Factor Assays.

Application Specialists shall (delete must )must be available for implementing and validating new assays, determining Ex Vivi heparin response curves, and providing statistical analysis for reagent lot correlations.

The systems shall (delete should ) utilize barcoded reagent tracking consisting of material name, lot number, expiration date, and on-board stability and volume.

Cap piercing capabilities; Safety features to avoid unnecessary exposure to biohazardous and chemical material.

Reagents and controls shall (delete must ) have extended stability times. Minimum stability of 7 days for PT, APTT reagents, and minimum stability of 24 hours for routine controls is required.

The systems shall (delete must ) have repeat and reflex testing capabilities based on user-defined criteria.

The systems shall (delete should) have a floor drain-compatible waste system.

The systems must have a quality control program with configurable multi-rules to evaluate the validity and accuracy of testing.

The Contractor shall provide peer comparison review and evaluation of quality control statistics.

The systems shall (delete must )have auto-programmable QC based on time, number of tests, and reagent changes.

The systems shall (delete must ) have clot curves to help troubleshoot abnormal, spurious, and unexpected results, identify factor inhibitors, and provide additional clinical information for patient assessments.

The systems shall only require minimal maintenance with online maintenance and quality control corrective action.

The systems must be LIS compatible with a bi-directional or host query interface.

Instrument-Analyzer software must be able to interface with VA-approved middleware software.

The systems must improve the overall productivity and efficiency of the Coagulation laboratory. The systems should be 100% walkaway and not require monitoring during the testing process.

Patient Mean Analysis Quality Control program: Required to have a QC program available on instruments or through middleware to monitor shifts and trends of test methods. Prefer company to have the ability to see instruments electronically for troubleshooting instrument and quality control problems.

Comprehensive on-board QC Program, including Troubleshooting or System Validation QC material. The system must have quality control data storage able to store up to 30 separate QC files at the hospital level with a minimum storage capacity of 6 months of QC files, two lot # of calibration for anti-10a, d-dimer and fibrinogen, and reporting capabilities, the ability to view and print daily and monthly QC results, view and print Levy Jennings graphs, visually alert the operator of QC failures and to document out of range QC. Prefer the ability to submit QC data electronically to the company for peer review and to be able to put in electronic comments to document troubleshooting or review of QC data. The routine quality control should be stable on board the analyzer for up to 24 hours with the ability to program the system to auto-execute QC runs.

DELIVERABLES:

Two (2) coagulation analyzers to include lease/service/maintenance, qty., 12 MO

AH NPR VA Outpatient Clinic - One (1) Coagulation Analyzer to include lease/service/maintenance.

JAH Lakeland VA Outpatient Clinic - One (1) Coagulation Analyzer to include lease/service/maintenance.

Printers, one for each testing site.

Uninterruptible power supply (UPS), one for each testing site.

ESTIMATED ANNUAL CPRR TESTING VOLUMES:

Facility Instruments Est qty/year: PT aPTT

JAH VA Hospital (JAHVH), 2 Coagulation Analyzers 44,000 28,000

JAH NPR VA Outpatient Clinic, 1 Coagulation Analyzer 5,000 1,000

JAH Lakeland VA Outpatient Clinic, 1 Coagulation Analyzer 5,000 1,000

Estimated Annual CPT Testing Volumes:

ESTIMATED REAGENTS AND SUPPLIES (One Year Estimated Volumes)

Item #

Stock #

Description/Part Number*

Qty

Unit

1

00020302400

HemosIL Rinse solution 4L

578.000

EA

2

00009757600

HemosIL Factor Diluent

143.000

EA

3

00009831700

HemosIL Cleaning Solution (Clean A)

275.000

EA

4

00029401100

CUVETTE WASTE LINER 10 PK, ACL TOP

1.000

EA

5

00027344900

CONTAINER, WASTE, 10 PACK

1.000

EA

6

00020013900

HemosIL Normal Control 1

96.000

EA

7

00020014100

HemosIL Abnormal Control 3

96.000

EA

8

00029403501

CTS FILTER

3.000

EA

9

00020003050

HemosIL RecombiPlasTin 2G (20mL)

100.000

EA

10

00020006800

HemosIL SynthASil

75.000

EA

11

00009832700

HemosIL Cleaning Agent (Clean B)

315.000

EA

12

00029400100

CUVETTES, ACL TOP, 6X100X4

120.000

EA

13

00020012500

HemosIL LA Positive Control

4.000

EA

14

00020012600

HemosIL LA Negative Control

4.000

EA

15

00020301500

HemosIL dRVVT Screen

5.000

EA

16

00020301600

HemosIL dRVVT Confirm

5.000

EA

17

00020004800

HemosIL Silica Clotting Time

10.000

EA

18

00020302602

HemosIL Liquid Anti-Xa

10.000

EA

19

00022550030

HEMOSIL D-DIMER HS 500 CONTROLS

26.000

EA

20

00020301800

HemosIL Q.F.A Thrombin (Bovine, 2mL)

12.000

EA

21

00020500100

HemosIL D-Dimer HS 500

70.000

EA

22

00020004200

HemosIL Low Fibrinogen Control

37.000

EA

23

00020300200

HemosIL LMW Heparin Controls

6.000

EA

24

00020300300

HemosIL UF Heparin Controls

60.000

EA

25

00020300600

HemosIL Heparin Calibrators

2.000

EA

26

00020003700

HemosIL Calibration plasma

2.000

EA

The actual Solicitation #36C24824Q0567 is anticipated to be posted to the Beta.SAM.gov website on or about 02/23/2023, closing date of 02/29/2023 @10am EST. Quoters should continue to monitor Beta.SAM.gov for the RFQ and any subsequent Amendments to that RFQ. All Quoters must be registered in the System for Award Management (SAM) database; see https://www.sam.gov for complete online Reps and Certs. SDVOSBs must be certified and verified in VetBiz.

The point of contact is Leonora Simmons, Contract Specialist, email: leonora.simmons@va.gov