Statement of Work Warfighter Screening_23Dec25.docx

STATEMENT OF WORK (SOW) FOR

AUTOMATED IMMUNOASSAY AND MOLECULAR TESTING PLATFORM FOR WARFIGHTER SCREENING

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 fully automated, walk away, fully integrated, random-access platforms, hereafter referred to as platform, capable of high throughput diagnostic testing. Epi Lab is seeking a five-year (base plus four option years) cost per test (kit) contract for instrumentation, instrument automation, middleware software, reagents, quality control, consumables (to include collection kits), and support to perform immunological and molecular analysis of the following clinical tests:

Immunoassays:

i. Human Immunodeficiency Virus 1/2 (HIV-1/HIV-2)

ii. Human T-Cell Lymphotropic Virus (Anti-HTLV I/II)

iii. Hepatitis B Surface Antigen (HBsAg) with an automated confirmation

iv. Hepatitis B Core Antibody (Anti-HBc)

v. Hepatitis C Virus (Anti-HCV)

Nucleic Acid Amplification Assays:

vi. Human Immunodeficiency Virus ½

vii. Hepatitis B Virus

viii. Hepatitis C Virus

B. All proposed platforms must accommodate a projected workload volume of 30K tests during the base year with a 20% increase per year for the subsequent four years.

C. All assays, both Immunoassays and Nucleic Acid Amplification Assays, must be approved by the Food and Drug Administration for use in donor screening of whole blood and blood components.

D. Immunoassay platforms must be capable of throughput of at least 280 results per hour. The vendor shall provide enough equipment, reagents, and consumables to complete an average daily test load within an 8-hour window. A guaranteed minimum of 95% uptime is required for all instruments.

E. Nucleic Acid Amplification must be capable of throughput of at least 380 results per 8-hour shift. The vendor shall provide enough equipment, reagents, and consumables to complete an average daily test load within an 8-hour window. A guaranteed minimum of 95% uptime is required for all instruments.

F. With the use of an FDA approved middleware which integrates both the Immunoassay and Nucleic Acid Amplification assay components of the mission.

G. The Immunoassay platform shall come equipped with onboard statistical analysis of QC data including QC lot numbers, means, ranges, standard deviation, and coefficient of variation percentages.

H. The Nucleic Acid Amplification platform must not release results from a batch or run that did not produce valid QC.

I. 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).

J. 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. Test orders and results must be sent automatically to the instrument and laboratory information system using auto download and auto verification (based on pre-written rules).

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

L. The platform must have continuous specimen loading capability.

M. 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.

N. 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.

O. 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.

P. If the platform requires a water source, the maintenance and service will be covered under this contract.

Q. If the platform requires a water source, the water system will contain at a minimum the following components:

i. An automated system capable of utilizing reverse osmosis to purify and deionize water.

ii. No less than two (2) mix bed sorbent tanks.

iii. No less than one (1) reverse osmosis polish tank.

iv. A component capable of removing CO2 gas from the water.

2. MINIMUM INSTRUMENTATION REQUIREMENTS:

A. Immunoassay incubation time of not more than 28 minutes. See above for tests and annual estimated volume.

B. Nucleic Acid Amplification testing must not exceed more than 4 hours from time to first result.

C. Immunoassay platforms capable of high throughput of at least 280 tests per hour.

D. Molecular instruments must have liquid level sensing to confirm adequate sample and reagent levels, must be able to process multiple specimen types simultaneously, and must be one integrated system with a single point of entry.

E. Sample Preparation for Nucleic Acid Amplification testing must include direct tube sampling with no sample manipulation/preparation prior to instrumentation analysis. This includes no off-board incubation or lysing, no removal of specimen swabs, and no manipulation of urine sample prior to testing on the instrument.

F. Sample directly from primary patient tube or an aliquot tube.

G. Capability to read sample bar codes.

H. Capability to read more than one bar code symbology.

I. Capability to load on the fly with uninterrupted operation with capability to add test packs without interruption of testing.

J. Detect if primary patient sample has inadequate volume for required testing.

K. Automatic clot detection.

L. Continuous specimen loading capability.

M. Automatic test reflex capability that are programmable by the user and within the LIS.

N. Auto-verification capabilities.

O. QC tracking for primary and secondary onboard reagents

P. Instrumentation shall demonstrate exceptional productivity and a successful first-time test run 95% of the time.

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. Upon request, the vendor shall provide sufficient reagents for in-house evaluation of each analyte.

C. Following evaluation, each test kits shall exhibit at least 95% agreement with test kits currently in use in the Laboratory. In the event there is not 95% agreement, the vendor shall provide technical support to assist Epi Lab personnel in identifying reason behind discrepant results.

D. Vendor shall provide assay kits that are optimized for use on instrumentation being provided.

E. The vendor shall provide troubleshooting for any failures that result from College of American Pathologist (CAP) proficiency testing.

4. MINIMUM MIDDLEWARE REQUIREMENTS:

A. Capability to locate specimen tubes within 2 minutes.

B. Capability to validate, release and reject results.

C. Ability to auto-validate/verify assays according to programmed rules.

D. Ability to display the following real-time metrics to the user: test turn-around time, percent of auto-verification, test volume, most recent quality control value(s) for all analytes listed in this SOW, sample integrity, and sample indices (hemolysis, icterus, lipemia).

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.

B. Training will include both onsite and off-site training at vendor’s facility. Off-site training will be a minimum of two per instrument provided plus two (2) per year over the length of the contract. The vendor will provide, all expense to include, but not limited to, travel, lodging, meals and any additional expense that are training specific.

C. Training and support for automation rules programming.

D. Installation will use current electrical and water supplies.

E. The vendor shall perform, at a minimum, the following initial instrument validation studies for each analyte listed in Section I, Part B of this SOW. This is required at initial installation and if a new piece of equipment is installed or a reagent is added for testing.

i. Simple Precision/Reproducibility

ii. Accuracy

iii. Method Comparison

iv. Instrument Correlation

v. Reportable Range

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 conforming 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 normal duty hours. Normally 0630-2200 EST Monday through Saturday. Possible 24/7 during surge operations.

E. Instrument downtime shall not exceed 48 hours for a single occurrence.

F. In the event of an instrument failure, the vendor shall provide onsite technical support within twenty-four (24) 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 the instrumentation back online in 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 twenty-four 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 machine 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.

G. 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.

H. 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.

I. 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.

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

K. 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.

L. 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.

M. 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.

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

O. 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.