Statement of Work Blood Banking_23Dec2025.docx

STATEMENT OF WORK (SOW) FOR

AUTOMATED BLOOD BANK TESTING

PLATFORM AT

UNITED STATES AIR FORCE SCHOOL OF AEROSPACE MEDICINE EPIDEMIOLOGY LABORATORY

WRIGHT-PATTERSON AIR FORCE BASE, OH

SOW TABLE OF CONTENTS

1. GENERAL REQUIREMENTS:

A. The United States Air Force School of Aerospace Medicine Epidemiology Laboratory, herein referred to as the Epi Lab is seeking a fully automated, walkaway, fully integrated blood banking analyzer, hereafter referred to as platform, capable of continuous high throughput in vitro immunohematology testing. Epi Lab is seeking a five-year (base plus four option years) cost per test contract for instrumentation, middleware software, reagents, calibrators, quality control, consumables, and support to perform automated pre-transfusion testing of patient and donor specimens of the following immunohematology tests:

i. ABO/Rh Group

ii. Antibody Screen (3-cell)

iii. Serial Dilutions for Titration Studies

iv. Quality Control (QC) Testing

B. The projected workload volume will be approximately 30K tests during the base year with a 20% increase per year for the subsequent four years.

C. Each platform must use column agglutination technology using gel cards.

D. Instrument must be capable of fully automated serial dilutions (e.g., anti-A and anti-B isohemagglutinin 1:256-point titers for Group O specimens).

E. The platform must automate blood bank test processes including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading and interpretation.

F. Testing platform must not use proprietary system liquids.

G. Platform must offer up to 24 hours walkaway time.

H. When operational, the platform must always be in a ready mode and at no time go into hibernation or ‘sleep’ state.

I. Supplier’s pe-diluted reagent blood cells must utilize United States based donors. Reagent red blood cells and column agglutination technology cards must use United States based manufacturing.

J. Vendor must supply a platform capable of benchtop installation.

K. Platform must have demonstrated the ability to supply automation and non-automated FDA licensed reagents for blood bank under their own brand.

L. Fully loaded waste containers shall each not weigh more than 11 pounds and be accessible at waist height.

M. Optical resolution of the on-board camera must be at least 5-megapixel resolutions down to 32 x 32 micron, and store a digital image of both the front and back of each gel card to record test results.

N. The platform through the instrumentation software or middleware meeting the requirements of Section 4 of this SOW, should notify the user when quality control (QC) values exceed the acceptable range set on each specific assay and must block the user from performing patient testing on said assay until such a time where QC is performed and values are within range.

O. The desired instrumentation shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

P. The platform must have a bidirectional computer interface that is compatible with the Defense Health Agency (DHA) Military Health System (MHS) GENESIS laboratory information system under the DHA Assess and Incorporate (A&I) process.

Q. The platform must have the capability of sampling from both a primary specimen tube or an aliquot tube.

R. The platform must detect if the specimen has adequate liquid level detection, automatic clot detection, and automatic cap detection without workflow interruption for required testing.

S. The platform must have continuous specimen loading capability.

T. Each analytical platform shall come equipped with an un-interruptible power supply capable of providing all necessary electrical power to perform an emergency shutdown, to include the data management station.

U. Safety Data Sheets (SDS) must be provided for each item delivered under this cost per kit agreement that is considered to be HAZARDOUS MATERIAL by the United States or the Contractor’s representative. The SDS shall contain information on the hazards associated with each specific chemical or material.

V. Environmental and Hazardous Materials Handling: If the disposal of any waste or byproduct of the platforms cannot be safely dumped into the facility’s drain, the vendor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.

W. Platform must use normal blood bank saline and distilled water which are standard blood bank items.

2. MINIMUM INSTRUMENTATION REQUIREMENTS:

A. Instrument must have liquid level sensing to confirm adequate specimen and reagent levels, must be able to process centrifuged whole blood, serum, plasma, packed red blood cells, 3% red cell suspension, and 0.8% red cell suspension specimens simultaneously and must be one integrated system with a single point of entry.

B. Instruments must be capable of reading specimen bar codes to identify accession numbers and specimen orders.

C. All windows based operating software must be Windows 10 or higher.

3. MINIMUM REAGENT REQUIREMENTS:

A. Instrument/reagent kits must be FDA approved and will provide analytical sensitivity along entire manufacturer’s stated measuring range.

B. The vendor shall provide the reagents and shall confirm with the ordering officer exact quantities and shipment schedule prior to shipment.

C. The minimum shelf life of the reagents will be six (6) months after the date of delivery. The government recognizes that some reagent items, kits and QC material will not meet this requirement at baseline.

D. Upon request or when a mandatory reagent changeover is required by the vendor, a technical specialist and sufficient reagents shall be provided by the vendor for in-house validation of new reagents that are added to the platform during the term of this contract.

E. Following the validation performed in Section 5, Part C, each reagent shall exhibit at least 95% agreement with test reagents currently in use, or with an outside laboratory, where applicable, as in the case of a new test introduced on the platform. In instances where there is not 95% agreement, the vendor shall provide support to determine cause of discrepancy.

F. The vendor shall comply with all current and future FDA and College of American Pathologist (CAP) regulations as required for accreditation.

G. The vendor will provide assistance troubleshooting any issues or failures that result from CAP proficiency survey testing.

4. MINIMUM MIDDLEWARE REQUIREMENTS:

A. The vendor shall provide a middleware product capable of interfacing with the instruments requested in this SOW and the Government’s laboratory information system, MHS GENESIS, utilizing a serial connection.

B. The middleware product for use with the donor screening reagents requires 510(k) clearance that can be used in Blood Bank environments.

C. The middleware product at no time will have or operate an IP address.

D. The vendor shall provide all terminal servers, cables, and hardware capable of sustaining a stand-alone computer workstation with the middleware product pre-loaded.

E. The middleware product shall be capable of user-defined rules written by the on-site user, specimen tracking, and intelligent metrics used for QC analysis.

5. MINIMUM INSTALLATION AND TRAINING SUPPORT REQUIREMENTS:

A. The vendor shall provide instrument transportation, delivery, and installation, to include calibration and test and system validation support, within 90 calendar days after the contract award.

B. The vendor shall provide initial operation and user maintenance training for two (2) personnel per instrument, to include transportation to and from training facility, hotel accommodations, and meals.

C. The vendor shall perform, at a minimum, the following initial instrument validation studies for each analyte listed in Section 1, Par A of this SOW:

i. Simple Precision/Reproducibility

ii. Accuracy

iii. Method Comparison

iv. Instrument Correlation

v. Reportable Range, as applicable

D. The vendor shall provide annual training for 2 Epi Lab personnel each year over the length of this contract.

E. The instrument shall demonstrate exceptional productivity and a successful first-time test run 95% of the time.

6. MINIMUM INSTRUMENT REPAIR AND MAINTENANCE REQUIREMENTS:

A. Must provide regular, scheduled maintenance to ensure the continued reliable operation of the equipment. These PM visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment.

B. Must provide all required tools, parts, and labor, as necessary, to keep the instrument in good operating condition. During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the designated representative of the Government at the using facility to replace the initial laboratory equipment with new equipment.

C. Vendor must provide replacement batteries for the un-interruptible power supply, as needed.

D. Must provide over the phone, instrument technical support during all duty hours. Normally 0630-2200 EST Monday through Saturday. Possibly 24/7 during surge operations.

E. In the event of an instrument failure, the vendor shall provide onsite emergency repair service within twenty-four (24) hours of dispatch on a reasonable effort basis unless otherwise stated. Service beyond normal coverage hours will be available at the prevailing time and material rates. The vendor is responsible for all tools, parts, travel/lodging, and labor that are necessary to bring the instrumentation back online within forty-eight (48) hours from service call. If an instrument remains inoperative due to a malfunction through no fault or negligence of the Government for a total of more than 24 hours, the vendor shall be assessed damages at the rate of 1/30 of the preceding average 3-month cost-per-test/reportable billings times the total number of days certified as downtime. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the vendor’s designated representative at the prearranged contact point until the instrument is returned in good operating order. However, if the delivery/task order provides for emergency repair during normal business hours in lieu of twenty-four-hour service, the non-contracted maintenance (Emergency Repairs) days will not be included in the downtime calculation.

F. In the case of all instruments simultaneously failing, the vendor shall provide onsite emergency repair within 8 hours of the time of notification of the malfunction. The vendor is responsible for all tools, parts, travel/lodging, and labor that are necessary to bring at least one instrument back online within 24 hours of the time of notification of the malfunction.

G. Scheduled routine services shall be performed between 0730-1630 Monday- Friday, except Federal holidays and when the government facility is closed due to local or national emergencies, administrative/weather closings, or similar government directed facility closings. For other than firm fixed price contracts, the vendor will not be reimbursed when the government facility is closed for the above reasons.

H. Emergency services, to include onsite emergency repair, shall be performed within twenty-four (24) hours following notification of an instrument failure, six (6) days a week, excluding federal holidays.

I. The vendor shall be responsible for the collection and transportation of equipment upon termination of the contract.

J. The vendor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the platform failure at no additional cost to the Government.

K. The vendor shall replace all reagents, calibrators, controls, and any other materials used by the Government in the process of troubleshooting instrument failure prior to the time of notification of the malfunction to the vendor.

L. The vendor shall furnish a malfunction incident report to the Government upon completion of each service call. The report shall include, at a minimum, date and time notified, date and time of arrival, serial number, type and model number(s) of platform(s), time spent for repair, description of malfunction and repair, and proof of repair that includes documentation of a specimen run of quality control verifying acceptable performance.

M. When required, the vendor shall comply with the Occupational Safety and Health Administration lockout and tag-out procedures while performing maintenance on electrical equipment.

N. If the platform requires a water source, all repair of the water source will be covered by the vendor IAW the afore mentioned repair timelines.

7. UPGRADE OF EQUIPMENT:

A. Subject to mutual agreement between the Government and the vendor, instrumentation may be upgraded within the specifications of the contract as new technology may become available.

B. Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the vendor and the Government through bilateral modification.