6640--Cost-Per-Test (CPT) autoimmune analyzer testing system

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 BioPlex 2200 Instrument System, MPN 660000, with UPS Back-Up System, MPN 660-0517, including service & maintenance, supplies/consumables included in 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.

The contractor shall provide an FDA-approved, fully automated, and integrated analyzer testing system, printer, computer, Uninterruptable Power Supplies (UPS) for the analyzer, and accessories required for equipment usage.

Below are the salient characteristics of the autoimmune FDA-approved instrument and FDA-approved reagents capable of performing ANA; Vasculitis; Anti-CCP IgG; APLS IgA-IgG-IgM; EBV IgG-IgM; HSV ½; Celiac IgA-IgG; MMRV IgG; Syphilis Total & RPR; and Lyme testing with specific functionality and performance-based requirements of the system:

General instrument characteristics include the ability to run FDA-approved patient testing for 100% of the below-listed tests on an FDA-approved, fully automated, random access, testing platform with priority processing:

Brand: BioRad Laboratories Inc.

Test

Base Year Estimated Test Volume

ANA

3,600

VASCULITIS

800

ANTI-CCP IgG

1,500

APLS IgA

600

APLS IgG

600

APLS IgM

600

EBV IgG

600

EBV IgM

600

HSV 1/2

1200

CELIAC IgA

2,500

CELIAC IgG

2,500

MMRV IgG

2,000

SYPHILIS TOTAL & RPR

6,500

LYME

600

a. Sufficient capacity and throughput to meet the volume and service demands as defined in the tests and volumes listed in section a. above.

b. Bar-coded primary patient sample tube entry capabilities.

c. Ability to run multiple assay protocols simultaneously.

d. Contractor shall provide all necessary software and hardware for the systems valid, acceptable, bidirectional interface data transmission through Data Innovation (DI) Instrument Manager (IM) middleware network connections.

e. Contractor shall provide all necessary system interface hardware and software upgrades as required for VA network compliance.

f. Contractor shall provide all upgrades to the equipment hardware and operating system software.

g. Operator and Service Manual shall be furnished with each model supplied. Electronic formats are acceptable.

h. Procedures shall be provided in accordance with the Clinical and Laboratory Standards Institute (CLSI) in editable format.

i. Contractor to provide all test kits, reagents, calibrators, controls, supplies, consumables, and Contractor assistance required for any instrument and method validations.

j. Additional testing may be added in support of patient care needs as determined by care providers.

k. Computer systems (CPUs, Monitors, Keyboards, Printers), and UPSs provided by the Contractor for the instrument throughout the contract period.

l. Our laboratory working space dimensions in inches ( ) are listed below. The contractor s analyzer system must fit within the space listed below:

i. 53 Height x 51 Width x 34 Depth.

m. Electrical Characteristics:

i. 100-240 VAC at 50-60Hz, 1000 Watts.

DELIVERABLES:

Brand name or equal to BioPlex 2200 Instrument System, MPN 660000 with UPS Back-Up System, MPN 660-0517, including service & maintenance, supplies/consumables included in the price of reagents,

Description - Kits, Controls, Calibrators, and Accessories

Unit

Qty

ANA Screen Reagent Pack 100 Tests

Pack

52

BioPlex 2200 Vasculitis Kit 100 Tests

Kit

11

BPX Anti CCP IgG 100T Kit

Kit

27

BioPlex 2200 APLS IgA Reagent Pack 100 Tests

Pack

12

BioPlex 2200 APLS IgG Reagent Pack 100 Tests

Pack

14

BioPlex 2200 APLS IgM Reagent Pack 100 Tests

Pack

14

BioPlex 2200 EBV IgG Reagent Kit 100 Tests

Kit

12

BioPlex 2200 EBV IgM Reagent Kit 100 Tests

Kit

13

BioPlex 2200 HSV 1/2 Reagent Kit 100 Tests

Kit

13

BioPlex 2200 Celiac IgA Reagent Kit 100 Tests

Kit

38

BioPlex 2200 Celiac IgG Reagent Kit 100 Tests

Kit

31

BioPlex 2200 MMRV IgG 100 Tests

Each

90

Syphilis Total & RPR Reagent 100 Tests

Each

55

BPX 2200 Lyme Total 200 Tests

Each

6

Reaction Vessel (1000)

Box

21

Bio-Hazard bag 14x19

Each

23

Instrument Sheath Fluid Box

Box

13

BPX 2200 Wash Buffer

Each

26

BPX Detector Calibration Pack

Each

7

Instrument Detector Clean Pack

Each

7

Instrument Probe Cleaning

Each

7

Sodium Hydroxide 1.0N Liter

Each

1

ANA Specific IgG Cal Kit

Kit

7

ANA Specific IgG Control Set

Kit

7

BioPlex 2200 Vasculitis Calibrator Kit

Kit

7

BioPlex 2200 Vasculitis Control Set

Kit

7

Anti CCP Calibrator Set

Kit

7

Anti CCP Control Set

Kit

7

Cal Set, Celiac IgA, BPX

Kit

7

Ctrl, Set, Celiac IgA, BPX

Kit

7

Cal Set, Celiac IgG, BPX

Kit

7

Ctrl, Set, Celiac IgG, BPX

Kit

7

BioPlex 2200 APLS IgA Calibrator Set (3 vials)

Pack

13

BioPlex 2200 APLS IgA Control Set (6 vials)

Pack

7

BioPlex 2200 APLS IgG Calibrator Set (7 vials)

Pack

13

BioPlex 2200 APLS IgG Control Set (6 vials)

Pack

7

BioPlex 2200 APLS IgM Calibrator Set (7 vials)

Pack

13

BioPlex 2200 APLS IgM Control Set (6 vials)

Pack

7

BioPlex 2200 EBV IgG Calibrator Set

Kit

8

BioPlex 2200 EBV IgG Control Set

Kit

8

BioPlex 2200 EBV IgM Calibrator Set

Kit

7

BioPlex 2200 EBV IgM Control Set

Kit

7

BioPlex 2200 HSV 1/2 Calibrator Set

Each

7

BioPlex 2200 HSV 1/2 Control Set

Each

7

BioPlex 2200 MMRV IgG Calibrator Set

Each

7

BioPlex 2200 MMRV IgG Control Set

Each

7

Syphilis Total & RPR Calibrator Set

Each

7

Syphilis Total & RPR Control Set

Each

7

BioPlex Sample Dilution Buffer, 120 mL

Each

5

BPX 2200 Lyme Total Calibrator Set

Each

4

BPX 2200 Lyme Total Control Set

Each

2

FUNCTIONAL AND PERFORMANCE CHARACTERISTICS:

Must provide the following functional and performance capabilities to ensure equipment is utilized and maintained according to the requirements of the system:

a. Preventive Maintenance shall be performed per manufacturer s guidelines.

b. Instrument service to be provided during routine business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements will be coordinated between the contractor and VA laboratory personnel.

c. Expected response to service call time from initial call to Contractor to service engineer arriving on site should be no more than 24 hours.

d. Technical Support Hotline must be available for in-house troubleshooting.

The actual Solicitation #36C24824Q0526 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