SOW - Analyzer.docx

REQUIREMENTS FOR CPT BLOOD BANK INSTRUMENTS

PATHOLOGY AND LABORATORY MEDICINE SERVICE

Blood Bank Instrumentation STATEMENT OF WORK (SOW) Tennessee Valley Healthcare System Purpose:

The purpose of this contract is to procure an Echo Lumena Blood Bank System (“Echo System”) via Operating Lease Contract for VAMC Nashville. Contractor will provide, maintain and retain ownership of all equipment supplied as part of this contract. The instrument(s) must be cleared by FDA for patient and donor blood bank testing.

1. PERIOD OF PERFORMANCE:

October 1, 2020 – September 30, 2021

2. PLACE OF PERFORMANCE:

1310 24th Ave. S, Nashville, TN 37212

3. DAYS AND HOURS OF OPERATION:

Monday- Sunday, 24 hours a day including federal holidays.

4. EQUIPMENT DESCRIPTION:

The Contractor shall provide (1) Echo Lumena Blood Bank System (“Echo System”) and will include complete training for personnel, repair/replacement service parts and vendor required preventive maintenance.

5. The instrument must perform the following test menu:

Immucor offers Capture Solid Phase technology to perform all listed tests. This technology is widely accepted and proven through many scientific papers to have superior sensitivity and specificity versus gel technology.

Estimated quantity of tests (estimate only)

6. The instrument must be capable of:

The instrument shall have random access. The instrument must use Capture Test Strips that must have a future date of 3 months at the time of delivery and must be stored at room temperature. In addition to automated testing, reagents would also be required for manual tube testing.

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority)

Instrument must be FDA approved and provide an Automated Blood Bank analyzer that uses Capture Solid Phase.

7. The contract must provide the following services:

· Contractor will provide all parts, labor, supplies and equipment needed to service the instrument when it is in down time.

· All service, repair and maintenance (other than user-performed maintenance) will be performed by the contractor with no additional expense to the government.

· Contractor will ensure that scheduled maintenance is performed and scheduled within the time frame specified by the cGMP of the instrument.

· Contractor will ensure that maintenance is scheduled with customers in advance of arrival on site.

· Service personnel must be trained and approved by the contracted vendor as required by the Manufacturer’s guidelines.

· Instrument validation must be provided by the vendor.

· Training must be provided by vendor, and all expenses for the training must be included.

· Instrument must meet all requirements as noted below.

· Standard Operating Procedures must be provided by the vendor.

· Instrument correlation must be provided by the vendor.

8. Required system features

· Equipment must be able to perform quality control, interpret quality control and document all lot numbers and expiration dates of the reagents.

· Instrument must save reaction strips or photographic evidence of reaction for up to 72 hours for review by supervisor when test is run during off hours.

· The system must use a maximum amount of two liters of solutions during daily processing (based on test volume noted).

· Instruments must be FDA approved for Immunohematology testing of both donors and patients.

· Each system must fit into a footprint of 64” width x 40” depth with weight less than 200 lbs due to counter size and capacity (unless manufacturer provided counter fits area assigned to testing).

· The system should have random access, batch processing, continuous sample loading, and Stat capabilities.

· Must accept loading of at least 30-unit confirmations at a time.

· Use of donor blood unit segment for confirmation and crossmatching without the need of spinning for packing red cells.

· Bar code reader must be able to read ISBT, Codabar, and Code 39.

· Must have ability to detect clots in patient samples and donor segments.

· Must perform complete test menu as listed above. All tests must have interpretation and actual recording of results.

· Power supply of 100-120 V.

· Must accommodate all common test tube samples (from 2ml to 8.5 ml of collected sample).

· Must be able to use plasma (CPD, CPDA-1, Na Citrate, K2 EDTA) or serum.

· Turnaround Time of 45 minutes or less for Type and Screen and crossmatch.

· The manufacturer must supply instrument maintenance of the instrument as required by FDA.

· Contractor must provide all parts, labor, supplies and equipment needed for service of the instrument.

· System must have a system for interphase with Department of Veterans Affairs Information System.

9. Training

· Contractor to provide off-site training classes (to include operation, user-performed maintenance, troubleshooting, and operation of middleware) for a minimum of two (2) VA operators at no additional cost to the VA. Training will be provided by individual(s) qualified to give instruction in the proper operation of the instrument(s). Additional vendor-performed on-site training of all users must occur prior to start of testing. Contractor to provide training plan with proposal.

· Contractor will provide three (3) days of training (up to eight (8) hours a day) to Customer operators (at the same time) at Customer’s facility during the week of installation. Training is intended to enable Customer to operate the System, and perform the ordinary maintenance and repair of the system.

10. Installation/Maintenance/Service/Project Management

· Vendor will provide a project manager who will ensure the installation is coordinated with VA and vendor staff to ensure that all aspects of installation are met to achieve go live date of October 1, 2020.

· System space, plumbing, and electrical requirements must not require major modifications to existing space.

· Installation of analyzer will be performed by contractor. Contractor will provide all parts, labor, supplies and equipment to install the analyzer and water system. Contractor will complete analyzer function checks during installation to ensure proper operation.

· Installation processes must include all validation studies (performed by contractor's technical specialist) and include the following: calibration, correlations, carryover, validation of all system features, and any other testing deemed necessary to validate the analyzer(s). All materials required to perform these studies will be provided by the manufacturer at no additional cost to the Pathology and Laboratory Medicine Service or the Tennessee Valley Healthcare VA Medical Center.

· The vendor will provide hard copies and CDs of System Service and Operational and Procedure Manuals, MSDS, and IFUs (Instructions for Use) of all configured assays.

· Validation studies are to be printed, organized in a binder, and presented to the VA for approval no less than two weeks prior to the system(s) go live date.

· All service, repair and maintenance (other than user-performed maintenance) will be performed by the contractor at no expense to the government (VA).

· Vendor to provide hazardous waste determination with proposal. The Hazardous Waste Determination is a procedure used to determine whether the by-products (liquid and solid waste) of an analytical process are characterized as a hazardous waste. This information to be provided based on the estimated workload as noted above.