36C26218Q0203-002.docx

RFQ 36C26218Q0203

STATEMENT OF WORK

VISN 22Pathology & Laboratory Medicine Service

Blood Bank Analyzer Automation Equipment and Associated Reagents/Consumables

1. Introduction: The VISN22 Pathology and Laboratory Service requests purchase of an automated blood bank analyzer and peripherals necessary for the generation of automated blood bank reportable patient testing.

This piece of equipment is highly specialized and FDA regulated. It will be the cornerstone of the blood bank and is essential to patient testing. It performs ABO/Rh typing, crossmatches, antibody screens and identifications, and confirmation typing of blood units essential for patient transfusion.

2. Minimum Requirements:

a. The automated blood bank analyzer shall have the capability of being interfaced with the VistA Blood Establishment Software (VBECS).

Meets the minimum requirement described above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

b. The system shall be capable of producing accurate and reproducible assays on biological samples with FDA approved methods for in vitro diagnostic methods. Model shall provide accurate test assay results up to the manufacturer’s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls. STAT turnaround time of 30 minutes regardless of whether the test mix is currently running at the fully burdened level.

Meets the minimum requirement described above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

c. The model being purchased shall be in current production as of the date the purchase is made. Remanufactured and discontinued models will not be accepted.

Meets the minimum requirement described above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

d. If there is a newer instrument released during the duration of the contract, VA facility should be given opportunity to replace existing instrument with the newer instrument on the same contract.

Meets the minimum requirement described above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

e. System shall be capable of performing the following:

1. ABO/Rh

2. Antibody Screen

3. Antibody Identification (panel with auto control)

4. Antigen typing

5. Direct Antiglobulin Test

6. Crossmatching Blood Units with Patient Samples

7. ABO and for Rh negative units Rh confirmation typing of donor units

8. Eluate panel

Meets the minimum requirement described above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

f. Instrumentation shall include:

1. Ablily to prioritize STAT samples for batch testing.

2. Offers continuous access with STAT priority.

3. Manual back-up test system

4. Able to load multiple reaction media at one time and have on board reagent stability with the ability to leave reagents on the instrument for multiple days.

5. Traceability of patient results, traceability of testing process and traceability of reagent lot numbers. Traceablility of result transmission. Traceability of result modification.

6. Able to perform antibody screen, antigen typing and crossmatch with same sensitivity and specificity using automated and manual back up method.

7. HL7 interface middleware

8. Electronically connected with predictive service alerts

9. If instrument includes Window operating system it should be compliant with minimum of Windows 7 Operating System.

Meets the minimum requirement described above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation:

g. Contractor shall:

1. Provide initial in-depth training for personnel operating the system for the five VISN22 Consolidated Pathology & Laboratory Medicine Transfusion Services.

2. Provide on-site validation of the equipment

3. Define the actual hands on maintenance time required for daily, weekly, monthly, and as needed maintenance. Contractor is to include the analyzer time required to perform each maintenance task and list which tasks are user level and which tasks are service level.

4. Provide a comprehensive QC program which includes the following options:

a. QC files that can be edited or corrected for errors

b. Have on-board quality control data storage and reporting capabilities

c. Ability to alert operator of QC failures

5. Provide low cost service contract pricing after warranty period

6. Identify who will provide service on the instrument

Meets the minimum requirement described above (y/n)?

Describe how the minimum requirement is met or exceeded:

File name of Contractor’s attachment, if providing additional supporting documentation: