36C24824Q0562 – Sources Sought – 6640–Supply: Coagulation Testing

Feb 11, 2024 | Sources Sought

Sources Sought Notice

Sources Sought Notice

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Sources Sought Notice
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Sources Sought Notice

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SUBJECT*
Supply: Coagulation Testing

GENERAL INFORMATION
CONTRACTING OFFICE S ZIP CODE*
33637
SOLICITATION NUMBER*
36C24824Q0562
RESPONSE DATE/TIME/ZONE
02-14-2024 10:00 EASTERN TIME, NEW YORK, USA
ARCHIVE
60 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
N
SET-ASIDE

PRODUCT SERVICE CODE*
6640
NAICS CODE*
334516
CONTRACTING OFFICE ADDRESS
Department of Veterans Affairs
Network Contracting Office 8 (NCO 8)

8875 Hidden River Pkwy Suite 525
Tampa FL 33637

POINT OF CONTACT*

Contract Specialist
Leonora Simmons
leonora.simmons@va,gov
813-972-7292

PLACE OF PERFORMANCE
ADDRESS
13000 Bruce B. Downs, Blvd.

Tampa FL.
POSTAL CODE
33612
COUNTRY
USA

ADDITIONAL INFORMATION
AGENCY S URL
https://www.va.gov
URL DESCRIPTION
VA website
AGENCY CONTACT S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

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Sources Sought Notice

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SOURCES SOUGHT
This source sought is issued solely for informational and planning purposes only. It does not constitute the issuance of a solicitation or a promise to issue a solicitation in the future.
The Department of Veterans Affairs, James A. Haley Veterans Hospital (JAHVH), 13000 Bruce B Downs Blvd, Tampa, Florida 33612, is seeking information from any SDVOSB-VOSB authorized vendor that is capable of providing a brand name or equal to WerFen instrumentation Laboratory ACL TOPs), including service & maintenance. The applicable NAICS is 334516- Analytical Laboratory Instrument Manufacturing (1,000 Employees SBA Size Standard).
See below specifications: Brand name or equal to Werfen.
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 an integrated data management system, external printer, and UPS.
All systems shall utilize the same operating system and user interface.
Instruments shall offer extensive test menus capable of performing assays for screening, monitoring, and diagnosis of bleeding and thrombotic risks.
Instruments shall have STAT processing capabilities without disrupting other testing in progress.
Instrument shall include integrated sample and reagent barcode readers capable of reading multiple barcode symbologies.
Instrument shall 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 an instrument cart.
Electrical Characteristics – 120 V.

NAME BRAND: WerFen (Instrumentation Laboratory ACL TOPs) OR EQUIVALENT Functionality and Performance Specifications:
The systems shall be barcode-driven, random access, with continuous loading and unloading of samples, reagents, and consumables.
The systems shall 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 shall 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 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 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 have extended stability times. A minimum stability of 7 days for PT, and APTT reagents, and a minimum stability of 24 hours for routine controls is required.
The systems shall have repeat and reflex testing capabilities based on user-defined criteria.
The systems shall have a floor drain-compatible waste system.
The systems shall have a quality control program with configurable multi-rules to evaluate the validity and accuracy of testing.
The Contractor shall provide a peer comparison review and evaluation of quality control statistics.
The systems shall have auto-programmable QC based on time, number of tests, and reagent changes.
The systems shall 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 shall be LIS compatible with a bi-directional or host query interface.
Instrument-Analyzer software shall be able to interface with VA-approved middleware software.
The systems shall improve the overall productivity and efficiency of the Coagulation laboratory. The systems shall 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 shall 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

This source sought is for market research purposes only and it does not commit the Government to contract for any supply or service whatsoever. At this time, The Department of Veteran Affairs is not seeking quotes, and will not accept unsolicited quotes. Respondents are advised that the United States (U.S.), government will not pay for any information or administrative cost incurred in response to this source sought. All costs associated with responding to this source sought will be solely at the responding party s expense. Please be advised that all submissions become Government property and will not be returned. Not responding to this Sources Sought does not preclude participation in any future solicitations. Responses to this notice are not quotes and cannot be accepted by the U.S. Government to form a binding contract. It is the responsibility of the interested parties to monitor the BETA.SAM.GOV (https://sam.gov/) Website for additional information about this source sought.
All responses to this Sources Sought shall be submitted to: Leonora Simmons at [email protected] no later than 02/16/2024 by 10:00 am EST.

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