Attachment 1_SOW - Supplies Working Werfen-Coagulation.pdf

10 August 2026

Statement of Work

For

Automated Coagulation System

I. Background:The 88th Medical Group Clinical Laboratory requires a new fully Automated Coagulation. The contractor shall provide two (2) integrated Coagulation analyzers of the latest technology available (no refurbished or remanufactured equipment allowed). The Coagulation Department performs approximately 2300 PT/INR, D-dimer, Fibrinogen, and PTT per year. Coagulation supports medical personnels ability to diagnose life threatening blood disorders and manage anticoagulant therapy to prevent excessive bleeding or clotting. An automated instrument allows for more accurate analysis, enhanced lab efficiency, reduction of human error and enabling a quicker diagnosis for patients. The current contract ends 12 SEP 2026 and our current instruments reach their life expectancy on 01 June 2027.

II. Minimum Technical Requirements:

a. The following specification lists the minimum requirements for the automated

Coagulation analyzer.

i. All equipment displays and supporting literature must be in the English language. Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, linearity material, and QC materials necessary to perform the specified assays, initial method validations per Clinical Laboratory Improvement Act of ’88 (CLIA) and the College of American Pathologist (CAP) guidelines.

ii. The analyzer should be fully automated, walk away, fully integrated and random access, capable of a throughput minimum of 100 tests per hour. WPMC is seeking a cost per reportable (CPR) agreement.

iii. All analyzers and associated parts and accessories will be new. Neither used, refurbished, or like-new equipment will be provided in support of this contract at any time.

iv. The Contractor is responsible for maintaining printers, peripherals, CPU, and other accessories throughout the duration of the contract period.

v. The contractor shall provide any external interference indicators that may affect the testing system that can cause inaccurate results for patient testing.

vi. All reagents and supplies allotted to operate the analyzers will be provided by the contractor.

vii. Performance period for this contract will be no more than 5 days from the date of award, and will run continuously for 12 months with the provision for a four time extension of this contract for additional 12-month periods.

viii. The desired instrumentation shall have the capability to automatically repeat or reflex samples, without manual intervention, by use of user defined decision rules and without the need for additional hardware or middleware.

ix. 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) and the College of American Pathologists (CAP)

x. The desired instrumentation shall require no more than a single workstation per analyzer to accomplish required testing listed below:

1. Prothrombin Time (PT)

2. Activated Partial Thromboplastin Time (aPTT)

3. D-Dimer

4. Fibrinogen

xi. Desired instrumentation, without the use of additional middleware, shall indicate to the user when quality control (QC) values exceed the acceptable range set by the user, QC reagent has expired, and/or it has been more than eight hours since the last acceptable QC value

xii. The desired instrumentation shall be capable of blocking the user from performing patient testing until such a time where QC no longer meets one or more of the conditions

xiii. The desired instrumentation should have a bidirectional computer interface that is compatible with MHS-Genesis.

xiv. The desired instrumentation shall have the capability for the user to enable results auto-validation into MHS-Genesis.

xv. The desired instrumentation shall be able to sample directly from Sarstedt® Collection Devices, i.e. without requiring users to aliquot from this collection device

xvi. The desired instrumentation shall have state-of-the-art technology featuring 671 nm LED-based clot detection, minimizing interference from lipemia, hemoglobin, and bilirubin.

xvii. The desired instrumentation shall have one single aspiration pathway, regardless of presentation mode, from point of aspiration to result, and shall be capable of allowing the operator to measure real-time reagent volume and quantity of tests available

xviii. The desired instrumentation shall use a digital barcode reader to provide a positive identification for all specimen tube labels and reagent labels

xix. The desired instrumentation shall have the capability to run automated closed tube, manual closed tube, and manual open tube samples

xx. The desired instrumentation shall have automated pre-analytical sample checks, detecting interference due to Hemolysis, Bilirubin, Lipemia, sample aspiration errors prompting the user to check for clots, and under filled tubes

xxi. The desired instrumentation shall have a quantitative D-Dimer assay with FDA exclusion of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE).

xxii. The desired instrumentation shall utilize a universal calibrator of Unfractionated (UF) and Low Molecular Weight (LMW) Heparins for one calibration curve

xxiii. The desired instrumentation shall have minimal maintenance, defined as less than 5 minutes of the combination of user ordering and automated performance of daily maintenance required to operate the analyzer.

xxiv. The desired instrumentation shall alert the user through the instrument interface when maintenance is due to be performed or is overdue

xxv. The desired instrumentation shall have the ability to present the user on the instrument interface with patient result clot curves, allowing the user to determine the acceptability of the patient result prior to release of information to MHS-Genesis

xxvi. The desired instrumentation should not require a water source to function.

III. Training:

a. The Contractor shall provide training for one primary operator per instrument at the

Contractor’s training site. The contractor will provide additional training on site when necessary. The cost of all training materials, transportation, lodging, and meals shall be included in the contract.

b. The Contractor shall provide all expenses, including travel, lodging, meals, and any additional training specific expense, for 1 Government laboratory technician per analyzer to attend one off-site training event, which shall include at least one continuing-education accredited workshop.

c. The Contractor shall provide supplemental operating training to Government personnel, without additional charge to the Government, upon installation of any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished under this agreement.

IV. Installation:

a. The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the contract and connections of all equipment and interconnecting wiring and cabling if applicable in coordination with the facility biomedical engineer. Upon receipt of notice from the COR, an agreed date will be established to proceed with installation. It shall be the Contractors responsibility to inform the COR of any problems which may be anticipated in connection with installation or those that will affect optimum performance once installation is completed.

The contractor will provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software and determined by the Laboratory Director, to provide technical assistance for the method validation studies. The contractor will provide a dedicated team of project management professionals who are experienced in delivering on time installations. The contractor shall not employ persons for work on this contract if such employee is identified to the Contractor by the COR as a potential threat to the health, safety, security, general well-being or operational mission of the installations and their population.

b. The contractor will provide an Information Technology Project Manager (IT PM) for implementation of the instrument interface with MHS-Genesis. The IT PM will have demonstrated working knowledge of Information Security requirements specific to DHA installations. The IT PM will work with the Department of War (DoW) subject matter experts (SMEs) to configure and test the instrument interface with MHS-Genesis. The IT PM will also collaborate with Laboratory SMEs to configure the system to need medical treatment facility (MTF) requirements.

c. The Contractor Shall specify any facility requirement such as electrical voltage, and special power supply required prior to equipment installation.

d. During the initial implementation, a technical representative must be available on site throughout the entire implementation period, ensuring the installation and validations be completed within 90 days of equipment arrival. The same technical representative (or Contractor designated replacement) should be available throughout the entire implementation; there must be documentation of information “hand off’ between the different Technical Representatives.

e. Upon completion of installation, on-site training, method validation studies, and analytical measurement range/linearity verification must be performed by Contractor personnel within the validation period to ensure that equipment is fully operational as negotiated.

f. Method Validation will be conducted in accordance with method validation protocols established by CLSI and / or required by CAP. Method Validation will include, but not be limited to, correlation with current methods, validation of analytical measurement range (AMR), validation of precision and accuracy, normal reference ranges, Heparin Response Curve, and establishment or verification of QC ranges. All reagents, QA materials, calibrators and linearity materials used in the Method Validation Study will be provided by the Contractor at no cost to the Government. These materials will not be used in the analysis of specimens for patient care.

g. Contractor shall perform all validation studies at no cost to the government to include manpower, linearity materials and reagents, calibrators, controls, and be consistent with current CLSI standards and related documents, CAP standards and Federal Regulations, for the following:

i. Correlation studies should include a minimum of 30 samples, spanning the reportable range, which should be run by the current and the new method.

Contractor should analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least the mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI. Linearity analysis shall be performed on new contracted instruments for each analyte to determine reportable range using statistical tool in accordance with CLSI.

ii. Precision study shall be performed utilizing normal and abnormal control materials. This should consist of a within-run precision study of 10 normal and abnormal control materials. This should consist of a within-run precision study of 10 normal and 10 abnormal controls or patient samples.

iii. Carryover studies shall be performed as applicable, as part of the initial evaluation of the instrument. The Contractor should provide interpretation of raw data and validate no carryover exists within testing system.

iv. Sensitivity: Sensitivity may be validated concurrently with the linearity verifications.

v. Specificity studies: Adverse effects or increased bilirubin, hemolysis, lipemia, or other interfering substances in plasma are evaluated for interfering substances for each method performed.

vi. Reference range: Determine a reference range for each test following CLSI guideline C23A. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. A certification of the manufacturer’s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects. The manufacturer must provide specific information defining how the suggested range was determined. A minimum of 30 reference individuals must be used to verify the manufacturer’s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification.

h. If the suggested manufacturer’s range is not appropriate for the patient population, a reference range must be established. Establishing a reference must follow CLSI-28A guidelines. This requires a minimum of 100 reference individuals to be used to establish a reference range.

i. Therapeutic range validation studies must be performed by contractor for applicable analytes.

j. The contractor will provide statistical reports of method validation study and all result print outs, package inserts of materials used for method validation study in an organized fashion, the Contractor will provide method validation study results and reports electronically. The contractor will provide instrument settings and other configurations on paper as well as electronically.

k. If progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be modified until such time as the cause of delay has been eliminated and then should be resumed within 24 hours after the contractor has been notified that work may again proceed.

l. The Contractor shall provide instrument transportation, delivery, and installation, to include calibration and system validation support, within 30 calendar days after the contract award.

m. The Contractor shall perform, at a minimum, the following initial instrument validation studies for each analyte.

i. Simple Precision

ii. Accuracy

iii. Method Comparison

iv. Instrument Correlation

v. Reference Range

vi. Reportable Range

vii. Therapeutic range, as applicable

n. The contractor will administer all corrective action for failed performance during initial validation until rectified and IAW CAP requirements.

o. The contractor will verify the analytical measurement range (AMR) and will provide necessary quality control materials, reagents, and consumables.

p. The contractor will complete additional necessary validation with upcoming laboratory move.

q. The contractor will customize the software to meet specific customer needs and provide updates at no additional costs.

r. The contractor will complete additional validation with upcoming laboratory move.

s. All contractor-owned equipment will be inspected and approved by the Biomedical

Equipment Maintenance (BMETs) section prior to use in the MTF. Contact Program Manager to schedule inspection.

t. The contractor shall provide a legible service report for the Medical Equipment Repair Center (MERC) personnel, signed off by the department, including the date, time, company name, and service representative, contract number, description of malfunction, description of any service performed and any recommendations necessary to maintain equipment in the best operating condition.

V. Required Supplies

a. Prothrombin time reagent should be a human recombinant product within ISI~1.0

b. Instrument must have a test specific check for hemolysis, icterus, and lipemia, with cutoff for acceptability that is FDA approved.

c. Instrument should be able to check for tube incorrect fill volume.

d. Instrument capable of detecting obstructions in the sample probe/clot check.

e. Instrument capable to visually alert and/or neglect testing to operator during quality control failures and ability to document out of range quality control.

f. D-Dimer must be high specific, with the option of liquid and ready for use.

g. D-Dimer has an FDA approved cutoff for the negative predictability for both

DVT and PE.

h. Instrument capability to store up to 10 calibration cures, current lot, new lot and previous lots.

i. Integrated sample barcode reader that is CLSI compliant for patient specimens.

j. Anytime load mechanisms for reagent, consumables and patient samples no wait system as to not hinder patient care.

k. System should have a clot curve to help troubleshoot abnormal, spurious and unexpected results.

l. Extended onboard stability >8 days for PT/PTT consumables and reagents.

m. 24-hour on-board stability of QC material.

n. Programmable for automatic QC processing for set intervals.

o. Ability to submit quality control data electronically for peer review.

p. Contractor should provide peer comparison review and evaluation of quality control statistics.

q. Repeat and reflex capabilities based on user define criteria.

r. Ability to view and print daily and monthly quality control results, Levy-Jennings graphs and instruments maintenance logs.

s. Availability of application specialist during reagent lot change correlations.

t. Minimal maintenance without instrument shutdown.

u. The Contractor must provide an estimate of the yearly quantities and Ship Schedule of reagent/reagent packs, calibrators/standards, quality control materials, and consumables required to perform the volume of reportable tests for each assay provided in Section I of this SOW.

v. The Contractor must consider requirements for routine quality control runs, routine calibration, periodic calibration/calibration verification in accordance with departmental policy and/or the CAP and troubleshooting of out-of-control assays when calculating the requirements.

w. The Contractor shall sequester quality control materials and test reagents where possible to minimize the amount of lot variations sent to the laboratory. The contractor shall create a standing order for reagents and supplies with Laboratory Supervisor and/or section lead and ship reagents and supplies as documented in standing order

x. All reagents provided shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows:

i. Be provided by the manufacturer of the equipment

ii. Be marked with the required storage temperature

iii. Inclusive of an English language package insert

iv. If bulk reagents are produced overseas, documentation of item equivalency must be provided.

v. All deliveries must be within a week from the scheduled shipping date and/or ordering date, tracked by the Contractor and provide the Government notifications if excess, or less than expected, is delivered. Any delays or unavailability must be immediately communicated (within 24 hours) to the Wright Patterson Air Force Base Laboratory. Additional compensation will not be provided to the Contractor for additional quantities shipped in error.

vi. The contractor will provide expedited shipping options to include overnight or next day, should emergent needs arise for any supplies provided by the Contractor. If supplies for emergent needs are ordered prior to overnight shipping cutoff it is expected that item will arrive within 24 hours of order being placed.

All supplies and materials necessary for operation of the instrument and performance of patient testing will always be available to WPAFB lab.

vii. Preservation and packing must be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against damage during shipment from source to destination. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box. All routine deliveries will be made Monday through Friday, to exclude Federal Holidays

viii. Reagents/materials must be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

ix. The contractor will provide shipment, and electronic tracking mechanisms whereby the Government is able to identify the shipping status of any materials.

Deliveries of required items must be in quarterly drop shipments. Orders must arrive no later than one week from the requested date of delivery. Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents, and delivered in a timely manner, not to exceed ten working days.

x. Routine or scheduled orders will arrive no earlier than one week before or after the date of delivery. Emergency orders will arrive no earlier than one week before or later than one week after the scheduled date of delivery.

Emergency orders will be delivered within 24 hours after the order is placed, if order is placed prior to Overnight/Next Day cutoff.

y. The Contractor shall ensure all reagents are delivered to 4881 Sugar Maple Dr., Wright Patterson AFB, OH 45433, ATTN: 88 MDSS SGSLA, BLD 830 Area A.

The contractor, or subcontractor if used, shall comply with

VI. Delivery:

SHIP TO DoDAAC: HT1135 POC: Daniel Fischer, 4881 Sugar Maple Dr, Bldg 830, Area A, Wright-Patterson

AFB, OH, 45433.

VII. Lead Time:

The contractor shall deliver ordered systems within 1 month after contract approval.

VIII. Warranty:

a. Contractor offers an extended service agreement that includes:

i. Two-hour Service Engineer phone response upon dispatch by the Technical Assistance Center

ii. Unlimited on-site service calls during business hours.

iii. All parts required for service will be provided by the contractor

iv. One year warranty is initially included and the service contract will be included for the full length of the contract.

IX. Delivery Procedures – Commercial Vehicles:

a. The company shall properly ship the system to the Air Force Institute of Technology at WPAFB, OH. All shipping costs to include insurance will be included in contractor’s proposal. Great care using standard, approved packaging methods shall be taken.

b. All vehicles larger than a large pick-up truck are required to be inspected by the Wright- Patterson Air Force Base Commercial Vehicle Delivery Gate (CVDG) prior to entering the installation. Vehicles to be inspected include, but are not limited to, the following:

1. Step van/panel truck

2. Tractor/trailer, box and flatbed containing cargo

3. Tanker trucks

4. Box trucks

5. Tour buses

6. Garbage/recycled waste trucks

7. Concrete trucks/mixers, dump trucks

8. Cranes, recreational vehicles, petroleum tanker

This inspection will be conducted at Gate 26A located off State Route 235.

c. The following are exemptions to vehicles utilizing the CVDG:

1. If the vehicle has the product inside (concrete and asphalt trucks) and timely delivery is necessary due to product deterioration it does not need to enter the CVDG. To bypass the CVDG, the contractor shall submit a list containing drivers’ names, social security numbers and the state in which the driver's license is held for those drivers who will be entering the base. This shall be accomplished 24 hours prior to requested entry time. If entry is requested on Monday, this list must be submitted by Friday at 1630 hours. All lists shall be submitted to the 88th ABW/CE Directorate contract inspector. The only gates that may be used under this exemption shall be 15A, 26A, 38A, and gate 1B. If the driver's name is not on the list, he/she will not be allowed access to the installation through these gates and the base will not assume liability for denied access.

2. If a delivery vehicle must exit, and then re-enter the base to complete its route, the vehicle shall be resealed upon exiting the base. After initially passing through the commercial vehicle delivery gate, trucks shall be resealed at Gates 15A, 38A and 22B. The resealing of the trucks will allow them to continue to any other area of the installation (Areas A, B, or Kittyhawk) without reprocessing through the CVDG. To receive resealing assistance, the drivers shall physically stop at one of the three authorized gates and request the installation entry controller to reseal their truck and provide the next location of their delivery. The controller will reseal the truck and give the delivery driver a pre-clearance form. The driver shall present the pre-clearance form to the entry controller at the next point of installation entry. This reentry can be through any base gate.

d. Vehicles may be subject to an inspection at any of installation entry control points during a directed random antiterrorism measure (RAM.) Any commercial vehicle, regardless of size, can be directed to the CVDG at the discretion of the installation entry controller.