DRAFT SOW_ (HPV) Molecular Analyzer Supply Reagent Rental.pdf

Statement of Work Human Papilloma Virus (HPV) Molecular Analyzer/Supply Reagent Rental

1. TASK ORDER TITLE/DESCRIPTION OF SERVICE: The Contractor shall provide a Cost Per test for Molecular Diagnostics analyzers and reagents capable of running multiplex testing for qualitative detection and genotyping of the DNA of Human Papilloma Virus (HPV) at Madigan Army Medical Center (MAMC). The platform may not be limited to HPV detection and genotyping and may be expanded to include other PCR testing for other pathogens. The contract is a 5-year renewal (base plus 4 options years). Instrumentation should perform molecular diagnostics with excellent quality, consistency, and 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). Contractor must provide all equipment, consumables, and supplies. Contractor must be able to perform the required scheduled maintenance. Contractor must be available to perform emergency services within 24 hours of service call and be completed within 48 hours of arrival. Contractor must have system in place, validated, and able to produce results on or before September 30th, 2024.

This contract shall be for 1 year and four 1-year option periods, beginning September 30th, 2024.

Contractor must also follow any requirements dictated by the AT/OPSEC Standard Contract Provision (explained in detail below). Contractor access to JBLM is only required to perform mandatory maintenance or troubleshooting.

2. BACKGROUND: Currently the Department of Pathology uses Molecular Diagnostic equipment for analysis procedures.

3. OBJECTIVES AND SCOPE: To maintain the latest instrumentation to provide quality patient care. Contractor shall have available all reagents, calibrators, controls, consumable/disposable items, parts, and accessories required to establish operation and perform all validation studies. 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 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. The contractor shall provide applicable manuals and schedules upon delivery and installation of equipment.

Contractor shall perform preventive maintenance 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. This facility is ultimately responsible for ensuring the manufacturers recommended daily, weekly, monthly, and periodic maintenance is performed.

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 all accessories required to fully operate the molecular diagnostic instrument(s). 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”.

4. GOVERNMENT FURNISHED ITEMS: The user will perform daily routine operator maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions.

5. SPECIFIC TASK: The purpose of this solicitation is to identify salient characteristics of a Molecular Diagnostics instrument(s) capable of performing FDA approved HPV Genotype Test with specific functionality and performance-based requirements of the system. The proposal shall provide descriptive literature that meets the following specifications:

A. Functionality and Performance Specifications:

Bar-coded data entry capabilities.

Bi-directional interface for host connection to connect to LIS.

Test-specific reagents.

Ready-to-use reagents, bar-coded cassettes.

The system must be able to direct load Thin Prep PreservCyt Solution vial without needing to aliquot the sample.

120 Voltage.

Must be able to provide system installation and set-up.

Computer system (CPU, Monitor, Keyboard, Printer,), UPS for all instruments for the life of the instruments.

Must be able to provide complete system validation (or assist facility with validation, as needed).

Must be able to provide training for staff how to use and troubleshoot the system.

Operate within the existing environmental conditions of 15-35 °C and 15-75% relative humidity.

Accepts multiple primary and secondary vial formats.

Able to identify both low and high-risk HPV at the same time.

Must be approved by the FDA for ASC-US triage, co-testing, and first-line primary screening.

HPV testing with internal cellularity controls ensuring no false negatives if used as a primary screening method.

Utilizing integrated HPV16/18 genotyping and 12 other high risk HPV genotypes.

The HPV test must use amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis.

The test specifically identifies (types) HPV 16 and HPV 18 while concurrently detecting the rest of the high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and

68) at clinically relevant infection levels.

Highly efficient signal excitation and data capture to reduce signal artifacts and ensure data integrity.

Pipette tip locking and monitoring technology, including CO-RE, TADM and anti-droplet control (ADC) for reliable sample transfer.

General instrument characteristics should include being able to run HPV DNA based assays on a RT-PCR technology-based platform in flexible batch sizes of 24 or 96 for efficient reagent usage.

A proprietary Kinetic Algorithm ensures results are positive, negative, or invalid and growth curve analysis is unnecessary.

Capable of multiplexing up to 6 detections per amplified sample.

An Internal Control/Quantitation Standard (IC/QS) incorporated into each individual sample and is carried through the sample preparation.

Collaborating controls should be included as part testing from the same manufacturer.

The systems must improve overall productivity in the Molecular Diagnostics Lab, reducing the need for repeat testing thus reducing reagent waste.

The system should be able to accept the primary specimen container.

The system should not require monitoring/user intervention during an extraction run and should be 100% “walk-away” system.

Overnight operation capabilities.

One test in one run, from one patient sample (1mL) eliminates the need for reflex testing and reduces the risk of insufficient quantity.

Able to destroy previously generated PCR amplification to help significantly reduce the risk of false positive results. Eliminate the use of bleach solutions to prevent cross-contamination issues.

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

Factor II/V BRAF HSV 1 and 2 EGFR v2

HPV KRAS

Cdiff CT/NG

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 and when 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.

D. AT/OPSEC

1. All contractor employees, to include subcontractor employees, requiring access to Army installations, facilities and controlled 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. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR, within 5 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

2. 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 Identification Verification for Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changed otherwise authorized by the changed 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.

3. The contractor and all associated sub-contractors shall brief all employees on the local iWatch program (training standards provided by the requiring activity ATO). This local developed training will be sued 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 30 calendar days of new employees commencing performance with results reported to the COR NLT 30 calendar days after contract award.

4. 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)

5. iWatch Training. The contractor and all associated sub-contractors shall brief all employees on the local iWatch program (training standards provided by the requiring activity ATO). This local 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 60 calendar days of contract award and within 60 calendar days of new employees commencing performance with the results reported to the COR NLT 60 calendar days after contract award.

E. DELIVERY OF EQUIPMENT:

1. The Molecular Diagnostics instrument shall (must) be delivered to the location as indicated below within 30 calendar days after contract award. Equipment setup, on-site training, and method validation studies shall (must) be completed by Contractor personnel within a period to ensure that equipment is fully operational on or before September 30, 2024.

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

7. PERIOD OF PERFORMANCE: Base (1 Oct 24– 30 Sep 25) + 4 one-year option periods.

8. GOVERNMENT POINT OF CONTACT: TBD