Attachment A.docx

Attachment A The Department of Veterans Affairs (VA), VISN 5 Network Contracting Office, is seeking vendors that can provide Automated Erythrocyte Sedimentation Rate Instrument for the Huntington VA Medical Center.

ITEM INFORMATION

New contract to acquire a new Automated Erythrocyte Sedimentation Rate Instrument. Base Year: Contract will be for two instruments which will include all reagents, materials, repairs, preventative maintenance and technical support for operations.

Contract Period: Base POP Begin: 10-01-2025 POP End: 09-30-2026

New contract to acquire a new Automated Erythrocyte Sedimentation Rate Instrument. Base Year: Contract will be for two instruments which will include all reagents, materials, repairs, preventative maintenance and technical support for operations.

Contract Period: Option 1 POP Begin: 10-01-2026 POP End: 09-30-2027

New contract to acquire a new Automated Erythrocyte Sedimentation Rate Instrument. Base Year: Contract will be for two instruments which will include all reagents, materials, repairs, preventative maintenance and technical support for operations.

Contract Period: Option 2 POP Begin: 10-01-2027 POP End: 09-30-2028

New contract to acquire a new Automated Erythrocyte Sedimentation Rate Instrument. Base Year: Contract will be for two instruments which will include all reagents, materials, repairs, preventative maintenance and technical support for operations.

Contract Period: Option 3 POP Begin: 10-01-2028 POP End: 09-30-2029

New contract to acquire a new Automated Erythrocyte Sedimentation Rate Instrument. Base Year: Contract will be for two instruments which will include all reagents, materials, repairs, preventative maintenance and technical support for operations Contract Period: Option 4 POP Begin: 10-01-2029 POP End: 09-30-2030

STATEMENT OF WORK (SOW)

Automated Erythrocyte Sedimentation Rate Analyzer

Hershel “Woody” Williams Veterans Affair Medical Center Pathology & Laboratory Medicine Service (113)

1.0 Introduction and Overview

The Hershel “Woody” Williams VA Medical Center, Pathology & Laboratory Medicine Service, is seeking a faster and more accurate method to perform the Erythrocyte Sedimentation Rate test, a test used to diagnose inflammatory conditions.

1.1 Background

Our current method is a fully automated process that takes approximately 20 seconds to obtain a final result. Retaining an automated process enables the Hematology Section to conduct multiple tests at the same time without affecting tests in progress and also minimizes pre-analytical error. This results in providing test results prior to a veteran/patient’s appointments on the same day.

Patient safety is in the forefront of healthcare delivery and supports a proactive approach to preventable medical errors. In adhering to the Mission Statement of the Hershel “Woody” Williams VA, it is our duty to provide exceptional care to improve the overall health and well-being of our Veterans and the completion of this project would accomplish such a goal.

Our goal is to purchase a reliable instrument with a quick result time. Contract will have a cost per reportable test result. This will include all reagents, materials, preventative maintenance, repairs and technical support required for operations and test reporting.

1.2 Scope of Work

1.2.1 To acquire two (2) identical Automated Erythrocyte Sedimentation Rate analyzers with quick result time. One analyzer would be a backup due to the need for a backup analyzer during downtime and avoid different reference ranges which could lead to an error in patient treatment if the provider is not aware of the different reference ranges of two different methodologies.

1.2.1.1 30 minutes or less test time

1.2.1.2 Must have full random access system

1.2.1.3 Must have automated read out/walk away automation

1.2.1.4 Must be an FDA approved clinical system and software.

1.2.1.5 Must be capable of LIS support using HL7 interface (VistA & Cerner Millennium)

1.2.1.6 Must have barcode scanner for patient identification

1.2.1.7 Ability to read barcode labels on individual tubes

1.2.1.8 Onboard quality control files.

1.2.1.9 Must have an Inter-laboratory QC program (Peer Group comparison).

1.2.1.10 Must have a mixer, if necessary

1.2.2 All equipment and configuration must meet VA specifications.

1.2.3 Operational and Technical Features: The instrumentation offered shall be available on the Contractor’s FSS Contract at the time of proposal submission and have the following:

1.2.3.1 Testing Instrumentation: Testing instrumentation shall have the following:

1.2.3.1.1 The capability and throughput to meet the volume and service demands.

1.2.3.1.2 A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. This includes interfacing with Cerner Millennium and VistA LIS. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system-

1.2.3.1.2.1 Equipment must be able to support multiple barcode formats that may be enabled concurrently.

1.2.3.1.2.2 Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric that may be enabled concurrently.

1.2.3.1.2.3 A barcode reading accuracy rate of 99% or greater.

1.2.3.1.3 Analyzer must function using an operating system that is approved to connect to the VA computer systems.

1.2.3.1.4 QC data management system and includes Levy-Jennings graphs. It is preferred that the analyzer can capture & store QC data.

1.2.3.1.4.1 Preferred capability to detect and alert operator of out of range quality control results via flagged results on QC printout and visual alerts on display monitor.

1.2.3.1.4.2 Ability to participate in peer data management system for quality control results.

1.2.3.1.5 Preferred on board reagent inventory management must have:

1.2.3.1.5.1 A system that provides reagent data to include but not limited to lot number and expiration date of reagents and quality control.

1.2.3.1.5.2 Barcoding of reagents.

1.2.3.1.5.3 On board reagent stability sufficient to accommodate both high and low volume use.

1.2.3.1.6 Primary tube sampling from evacuated whole blood EDTA collection tubes from various manufacturers.

1.2.3.1.7 The ability to continuously load patient specimens.

1.2.3.1.8 The ability to detect short samples if applicable.

1.2.3.1.9 The ability to perform testing on samples with a minimal amount of whole blood.

1.2.3.1.10 The ability to perform mixing of samples on board the analyzer.

1.2.3.1.11 The ability to measure directly the intensity of the red cell aggregation.

1.2.3.1.12 Instruction/Operation manual for use and maintenance.

1.2.3.1.13 Statement of warranty of equipment, minimum one year.

1.2.3.1.14 The vendor shall provide 24/7 technical support either by phone or onsite support.

1.2.3.1.15 The contractor will remove all equipment within 90 days after notification of expiration of the terms of this BPA but not until the completion of the new vendor’s equipment installation inclusive of completed cross over studies. Each facility, per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade. If a VA facility chooses to retain the hard drive, it will be at no additional cost to the VA.

1.2.3.1.16 The vendor must provide education/training on site - basic operating and maintenance training during installations or update to the equipment.

1.2.3.1.17 Antivirus software will be provided by the vendor at no additional cost.

1.2.3.1.18 The vendor shall provide the following interfacing requirements for the system: Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer. Any required (additional) interface connection license(s). Instrument- LIS interface must be bi-directional. Provide documentation of successful interfacing with other VA facilities (provide two VAMC references to include contact person, address, and telephone number). Interface must use automatic host query to download sample ID’s, test requests, and patient demographics. Instrument interface must transmit test results to the host computer system via automatic upload.

1.2.3.1.19 The system shall be able to store and retransmit records (24 hours of maximum instrument throughput) in case of interface downtime. The vendor is to state how many samples can be stored. The system shall have the ability to edit sample/patient identifier after interface downtime and then be able to resend the sample/patient information to the host for verification.

1.2.3.1.20 Installation must include all evaluation/comparison data sufficient to satisfy CAP standards. Vendor must provide all cross-over supplies and reagents.

1.3 Objectives: Provide timely and high-quality test services for direct care of veterans through procurement of Automated Erythrocyte Sedimentation Rate analyzers. Enable Hematology Technologists to accurately and quickly report the result to the providers.

1.4 Place/Period of Performance: Analyzer use is continuous for direct care of veterans in the Hematology section.

2. Tasks: Deliver two Automated Erythrocyte Sedimentation Rate analyzers to the Hershel “Woody” Williams VA Medical Center, Pathology and Laboratory Medicine Services located 1540 Spring Valley Drive, Huntington WV, 25704.

3. Space/Utilities: The section has sufficient space and utilities for the requested analyzers.

4. Estimated Annual Volume: 2500 tests/year