W81K0225QA079 Intent To Sole Source Attachment 1 SOW 07-09-2025.pdf

W81K0225QA079 Attachment 1 Statement of Work Multiplex Molecular Analyzer/Supply Reagent Rental

1. BACKGROUND: The Madigan Army Medical Center (MAMC) Department of Pathology requires an equipment rental contract for a multiplex molecular analyzers to maintain timely laboratory testing capabilities. The system must be able to perform multiplexed nucleic acid tests that can simultaneously detect and identify multiple pathogens within 90 minutes of test initiation.

The system must have random access capability for at least four separate specimens regardless of source. The real-time polymerase chain reaction (rt-PCR) instrument with assays for the detection of common bacterial, viral, fungal, and parasitological pathogens from positive blood cultures, cerebral spinal fluid (CSF), upper respiratory (nasopharyngeal), lower respiratory (sputum, bronchiolar lavage, and tracheal aspirate) specimens and bio-threat agents (e.g.

Bacterial - Bacillus anthracis, Francisella tularensis, Leptospira spp., Yersinia pestis. Viral - Chikungunya virus, Crimean-Congo hemorrhagic fever virus, Dengue virus, Ebola virus spp., Lassa virus, Marburg virus, West Nile virus, yellow fever virus. Protozoan – Leishmania spp., Plasmodium spp.)

The contractor must be able to perform the required scheduled maintenance and provide the government with all hardware and software upgrades to maintain a fully functioning system.

The contractor must be available to perform emergency services within 24 hours of service call and be completed within 48 hours of arrival.

The MAMC Department of Pathology currently uses the BioFire FilmArray TORCH system.

The TORCH is a multiplex rt-PCR instrument that consists of four, random access, testing modules. The TORCH has assays available for testing samples from positive blood cultures, nasopharyngeal swabs, lower respiratory specimens, and cerebral spinal fluid. The multiplex capability allows the TORCH to simultaneously identify multiple pathogens (bacterial, viral, fungal) from each sample Turn-around-time is under 1.5 hours. It is also a self-contained system that limits the potential for contamination and allows for easy setup and operation by laboratory technicians.

2. SPECIFIC EQUIPMENT: The contractor shall supply the below listed equipment:

Name Manufacture # Lease of BioFire Torch System

Torch Base (Lease) HTFA-ASY-0001 Torch Duplex (Lease) HTFA-ASY-0002 Torch Modules (Lease) HTFA-ASY-0003

Lease of BioFire Spotfire System Spotfire Control Station (Lease) FAST-ASY-0001 Spotfire Modules (Lease) FAST-ASY-0002

Supply of Testing Panels Reagents BioFire Torch Blood Culture Identification 2 Panel kit, 30 Pack (Supply)

RFIT-ASY-0147

Gastrointestinal Panel IVD, 30 Tests (Supply) RFIT-ASY-0116 Meningitis/Encephalitis Panel IVD, 30 Tests (Supply) RFIT-ASY-0118 Pneumonia Panel IVD, 30 Tests (Supply) RFIT-ASY-0144 FilmArray NGDS Warrior Panel IVD, 30 Tests (Supply) NGDS-ASY-0007 BioFire Global Fever Special Pathogens Panel IVD, 6 Tests (Supply)

DFA2-ASY-0018

BIOFIRE SHIELD Control Kit for the Global Fever Special Pathogens Panel, 12 Controls (Supply)

DFA2-ASY-0019

SPOTFIRE Respiratory/Sore Throat Panel, 30 Tests (Supply)

423485

3. OBJECTIVES AND SCOPE: To maintain the latest instrumentation to provide quality patient care. Contractor shall provide all required reagents, calibrators, controls, consumable/disposable items, parts, and accessories required to establish operation and perform all validation studies within the limitations of the base contract and resulting delivery orders.

The contractor shall provide all listed Testing Panels Reagents ordered under an associated delivery order within 7 calendar days of delivery being requested. The contractor shall coordinate deliveries with the COR. All delivered Testing Panels Reagents will have a minimum shelf life of 3 months from the date of delivery. All Testing Panels Reagents will be shipped and maintained with proper packaging and temperature control as necessary.

Contractor shall provide installation and training services. Contractor shall provide all maintenance and support to ensure a minimum of 95% uptime on all analyzers.

The quantities provided on the CLIN’s reflect estimated usages by the government over the 5-year ordering period of the contract. Actual usage rates will vary depending upon test order by the health care provider and number of patients seen by Madigan Army Medical Center. The government reserves the right to increase the quantity of the tests within 15% of the initial CLIN quantity at the prices established in the contract.

4. GOVERNMENT RESPONSIBILITIES: The user will perform daily routine operator maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The government will follow the manufacturers recommended daily, weekly, monthly, and periodic maintenance is performed.

5. SPECIFIC TASK:

5.1 Salient Characteristics of Analyzer Systems:

A. Functionality and Performance Specifications:

• Direct from specimen testing

• The system must be able to perform multiplexed nucleic acid tests that can simultaneously detect and identify multiple pathogens.

• Walk away instrument, no additional technician steps required once the assay run is started until complete.

• Random access, on demand analyzer

• Must be able to process minimum of four discrete patient specimens, regardless of assay type, simultaneously.

• Modules must be under the control of a single processor.

• Room temperature storage of reagents and consumables

• Technician time required to process a patient specimen not to exceed 5 minutes.

• Time from specimen loading to result will not exceed 90 minutes.

B. The contractor shall provide instrumentation that can perform the following testing capabilities:

a. Positive Blood Cultures

i. Gram positive organisms (e.g. Staphylococcus aureus)

ii. Gram negatives (e.g. Enterobacteriaceae, Pseudomonas aeruginosa)

iii. Yeast (e.g. Candida albicans)

iv. Antimicrobial resistance genes (mecA, vanA/B, KPC)

b. Upper Respiratory Pathogens

i. Viral pathogens (e.g. Influenza A/B, Respiratory Syncytial Virus)

ii. Bacterial pathogens (e.g. Bordetella sp., Mycoplasma pneumoniae)

iii. Sore throat (Streptococcus dysgalactiae (group C/G strep), Streptococcus pyogenes

(group A strep))

iv. Able to test from nasopharyngeal swab.

c. Lower Respiratory Pathogens

i. Viruses (e.g. Influenza A/B, Parainfluenza, Adenovirus)

ii. Bacteria (e.g. Staphylococcus aureus, Streptococcus sp. Enterobacteriaceae)

iii. Antimicrobial resistance genes (mecA, KPC, CTX-M)

iv. Able to test Bronchiolar lavage (BAL), Sputum, Endotracheal Aspirate

d. Meningitis Encephalitis

i. Viruses (e.g. Herpes Simplex Virus, Enterovirus, Cytomegalovirus)

ii. Bacteria (e.g. Neisseria meningitidis, Listeria monocytogenes)

iii. Yeast (e.g. Cryptococcus neoformans/gattii)

iv. Able to test CSF.

e. Gastrointestinal Pathogens

i. Viruses (e.g. Adenovirus 40/41, Norovirus GI/GII, Rotavirus A)

ii. Bacteria (e.g. Plesiomonas shigelloides, Vibrio, Yersinia enterocolitica, Enterotoxigeinc Escherichia coli [ETEC])

iii. Parasites (e.g. Cyclospora cayetanensis, Giardia lamblia, Cryptosporidium)

f. Bio-threat agents

i. Bacteria (Bacillus anthracis, Francisella tularensis, Leptospira spp., Yersinia pestis, Coxiella burnetiid)

ii. Virus (Chikungunya virus, Crimean-Congo hemorrhagic fever virus, Dengue virus (serotypes 1, 2, 3 and 4), Ebolavirus spp. (Bundibugyo, Reston, Sudan, Taï Forest, Zaire), Lassa virus, Marburgvirus, West Nile virus, Yellow fever virus)

iii. Protozoan (Leishmania spp., Plasmodium spp., Plasmodium falciparum, Plasmodium vivax/ovale)

C. Information Management

1. The Molecular Diagnostics instrument must be capable of interfacing with the military hospital computer system, i.e., the Anatomic Pathology Laboratory Information System (Genesis). The Contractor must have an established driver compatible for interfacing the Molecular Diagnostics instrument with Genesis.

a. The Contractor shall assist with future migration of laboratory information system (LIS) if that may occur at no additional cost to the government.

2. The software shall provide proactive monitoring of key instrument parameters to allow for predictive diagnostics.

5.2 Installation of Equipment:

The contractor shall provide applicable manuals and schedules upon delivery and installation of equipment. Contractor shall provide all accessories required to fully operate the molecular diagnostic instrument(s) at time of installation. Contractor shall provide all necessary supply and technical support to complete the validation study after the installation of equipment.

In addition, the contractor shall include all ancillary components customarily provided with the model of equipment furnished to Madigan Army Medical Center, e.g., starter kits. The contractor shall provide a statement and description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations that addresses the elements and criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment”. Contractor shall provide all necessary resources to complete validation studies which includes Panels/test kits, supplies, and validations kits.

5.3 Service and Contractor Maintenance and Support:

Contractor shall perform preventive maintenance, routine calibration, and inspections during the contract period arranged with the COR in accordance with the published preventive maintenance manuals for the equipment. Contractor shall utilize the original equipment manufacturer’s established preventative maintenance procedures and checklists. A field service report shall be supplied to the COR at the completion of each preventative maintenance inspection and at the completion of any unscheduled maintenance request. If the repair of any individual piece of the contractor’s equipment reflects a downtime of 5% or greater of the normal working days in a one calendar month from the time of dispatch, the designated representative may decide to have the contractor replace the malfunctioning equipment with new equipment at no charge to the government. The contractor is ultimately responsible for ensuring its equipment is furnished in good condition in accordance with manufacturer’s instructions.

Vendor must provide upgrades to both the hardware and software to maintain the integrity of the system and the state-of-the-art technology at no additional charge. Contractor shall provide telephone support 24 hours per day, 7 days per week.

5.4 Analyzer Training After Installation:

Contractor shall provide key operator training in the proper use of the instrument as part of the contract. Training shall be coordinated with the COR and in conjunction with the installation of the equipment. Training shall include system operations, data manipulation and basic troubleshooting, routine maintenance and repair. If training is to be conducted off site, it should be for no less than 2 individuals and at no cost to the government.

6. BASE ENTRY & COORDINATION:

Contractor access to Joint Base Lewis McChord will be required to perform mandatory on-site maintenance or troubleshooting. The Contractor shall coordinate with the COR to ensure base access is maintained throughout the life of the contract to be capable of responding for required on-site repairs, troubleshooting and maintenance as outlined in Section 5 above.

a. AT LEVEL I TRAINING: All contractor employees, including subcontractor employees, requiring access to DHHQ, Direct Reporting Markets (MTFs), Small Markets and Stand Alone (SSO) facilities and controlled access areas, shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable and annually thereafter. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 05 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil.

b. ACCESS AND GENERAL PROTECTION POLICY AND PROCEDURES:

Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of http://jko.jten.mil/

Contractor Personnel) as directed by DOD, DHHQ and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

FOR CONTRACTORS THAT DO NOT REQUIRE CAC, BUT REQUIRE ACCESS

TO A DOD FACILITY OR INSTALLATION: Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

c. iWATCH/SUSPICIOUS ACTIVITY REPORTING TRAINING: The contractor and all associated subcontractors shall brief all employees on the local Suspicious Activity Training program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 05 calendar days of new employees commencing performance, with the results reported to the COR NLT 30 calendar days after contract award.

d. OPSEC TRAINING: Per DHA-AI 5200.03, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

e. THREAT AWARENESS REPORTING PROGRAM: For all contractors with security clearances. Per DHA-AI 097, Insider Threat Program, contractor employees must receive annual Insider Threat Awareness training within 30 days of initial employment, and refresher training annually either through instructor-led or computer-based.

7. PLACE OF PERFORMANCE: Madigan Army Medical Center Attn: Anatomic Pathology, Department of Pathology Tacoma, WA 98431

8. ORDERING PERIOD: The ordering period of this contract will be for 5 years. See Clause 52.216-18 within the contract.

9. Contracting Officer’s Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions:

-Coordinates delivery for required supplies, technical support and or installation of Analyzers;

-Assure that the Contractor performs the technical requirements of the contract;

-Perform inspections necessary in connection with contract performance;

-Maintain written and oral communications with the Contractor concerning technical aspects of the contract;

-Issue written interpretations of technical requirements, including Government drawings, designs, specifications;

-Monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies;

-Coordinate credentialing and site entry of Contractor personnel.

The COR is NOT authorized to change any of the terms and conditions of this contract. Only the warranted Contracting Officer is authorized to make modifications/changes to the terms and conditions of this contract. If the Contractor believes any Government personnel has effectively issued a change resulting in a change in effort and price/cost of the contract, the Contractor shall immediately notify the Contracting Officer in writing.

COR:

To be Determined**