SOW DRAFT.pdf

Statement of Work

1. TASK ORDER TITLE/DESCRIPTION OF SERVICE: The Department of Pathology is requesting a contract for reagents for the detection of Herpes simplex virus (HSV 1 and 2), Congenital cytomegalovirus (CMV), Candida auris (C. auris), and Varicella Zoster Virus (VZV) at Madigan Army Medical Center (MAMC). The system will include a direct from specimen, qualitative nucleic acid testing analyzer with FDA-approved assays for HSV-1/2, VZV, CMV and C. auris; workstation/laptop/CPU; and uninterruptable power supply. Two systems will be part of the contract to ensure uninterrupted patient care during downtime, multiple analyte testing, and/or maintenance requirements of the system. The platform may not be limited to HSV-1/2, VZV, CMV and C. auris testing and may be expanded to include amplification-based molecular testing for other pathogens in the future depending on the patient testing needs at MAMC. 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 be able to perform bi-annual calibrations and/or preventive maintenance. Contractor must be able to perform emergency services within 24 hours of service call and completed within 48 hours of arrival. Contractor must follow any requirements dictates by the AT/OPSEC Standard Contract Provision, be able to meet requirements for an Authority to Operate (ATO) on the DHA network and be able to bi-directionally interface with the LIS. Contractor must provide all equipment, consumables, and supplies. Contractor must have system in place, validated, and able to produce results on or before September 30th, 2025. This contract shall be for an IDIQ with a 5-year ordering period, beginning October 1st, 2025. Contractor access to JBLM is only required to perform mandatory maintenance or troubleshooting.

2. BACKGROUND: The MAMC Department of Pathology currently uses the Diasorin LIAISON MDX system. Diasorin LIAISON MDX is an instrumentation for running the qualitative, molecular detection of Herpes simplex virus (HSV 1 and 2), Congenital cytomegalovirus (CMV), Candida auris (C. auris), and Varicella Zoster Virus (VZV) organisms at Madigan Army Medical Center (MAMC). Liaison MDX system detects the above analytes direct from specimen in the appropriately validated specimen matrices. This is the only system that fully claims FDA-approved testing for individual all four analytes in the specified patient matrices outlined in the salient characteristics. This facility would strongly like to continue the use of the Diasorin LIAISON MDX to continue to provide quality diagnostics which aid in a diagnosis and overall patient care.

3. OBJECTIVES AND SCOPE: To maintain the latest instrumentation to provide quality patient care for HSV-1/2, VZV, CMV and C. auris testing in a timely manner. The platform may be expanded to include amplification-based molecular testing for other pathogens in the future.

Contractor shall have available all reagents, calibrators, controls, consumable/disposable items, parts and accessories required to establish operation and perform all validation/verification 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 contractors 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 make a determination 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 in order 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. validation/verification 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 nucleic acid amplification instrument(s) capable of performing FDA-approved, qualitative HSV- 1/2, VZV, CMV and C. auris assays with specific functionality and performance-based requirements of the system. The proposal shall provide descriptive literature that meets the following specifications:

A. Characteristics:

1. FDA-approved, qualitative molecular assays for:

a. HSV-1/2 from cutaneous & mucocutaneous swabs to include anogenital and non-anogenital sites, and CSF

b. VZV from cutaneous & mucocutaneous swabs, and CSF

c. CMV from saliva and urine

d. C. auris from the armpits and groins

2. Must be capable of direct amplification of specimen without an additional extraction step.

3. Generates results in less than 1.5 hours.

4. Must be capable of processing at least 8 samples per run per instrument without reagent waste if less than the full cartridge/disk/cassette is utilized.

5. Must have an extraction and amplification process control.

6. Must supply external positive controls to meet lab QC requirements.

7. Automated sample ID scanning on the system to ensure sample/assay/reagent positive match.

8. Bar-coded data entry capabilities.

9. Must process liquid level detection capability to confirm adequate sample and reagent levels.

10. Bi-directional interface for host connection to connect to Laboratory Information System

(LIS) and system must be capable of automatically sending patient results to the LIS.

11. Ready-to-use reagents, bar-coded cassettes/disks/cartridges.

12. Must have an open channel for additional molecular assays that are LDT or non-FDA approved primers.

13. FDA-approved molecular detection for additional pathogens may be incorporated on this testing platform in the future.

14. Dimensions for individual analyzer must be able to fit on a standard lab benchtop and be no greater than 24 in x 24 in x 24.

15. Contractor must be able to perform emergency services within 24 hours of service call and completed within 48 hours of arrival.

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

17. Computer system (CPU, Printer) & UPS for all instruments for the life of the instruments will be supplied by the vendor.

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

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

20. Operate within the existing environmental conditions of 15-32°C and <80% relative humidity.

21. The test(s) specifically identifies HSV-1/2, VZV, CMV and C. auris at clinically relevant infection levels.

22. Assay can distinguish between HSV 1 and HSV 2 in a single assay.

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

24. The system should not require monitoring/user intervention during a run.

25. System cannot require remote diagnostics for troubleshooting or required software updates.

26. Overnight operation capabilities from start of specimen to finish.

27. Must be able to obtain an ATO to operate on the DHA network within 1 year following start of contract and meet cyber security/network requirements.

C. Performance Specifications and Requirements:

The following performance objectives and measures will be used to evaluate Contractor performance and compliance under the contract. This information will be used to prepare annual past performance evaluations, when required. See Exhibit 1, Quality Assurance Surveillance Plan (QASP), for additional details.

Exhibit 1.

PERFORMANCE

REQUIREMENT

PERFORMANCE

STANDARD

PERFORMANCE

LEVEL

SURVEILLANCE

METHOD

1. Method Validation for new assays.

Method Validation for new assays will be conducted in accordance with method validation protocols established by the Department of Pathology’s Quality Management Program

Meets - 99% based on the number of new assays implemented each performance period.

Review assessment of Method Validation results.

COR Monitors

2. Contractor shall provide telephone support 24 hours per day, 7 days per week.

Provides telephone support 24 x 7 as required.

Meets - 99% based on the number of calls placed each month.

Continuous monitoring. COR Monitors

3. Repair service engineer responds with 24 hours after notification for routine/ emergency failures

Response for repairs as required.

Meets – 99% based on the number of service visits placed each month

Repairs completed.

COR Monitors

4. The Contractor delivers reagents within one (1) week after delivery is requested.

Agents delivered as required.

Meets – 95% based on the number of reagents delivered each month

Review of delivery documents. COR Monitors

5. The minimum shelf life of the reagents will be three

(3) months after the

Agent minimum shelf life meets requirements.

Meets – 99% based on delivered reagents.

Site may refuse shipment at

Continuous monitoring shelf life dates. COR date of delivery. Contractor’s return shipping cost if this requirement is not met.

Monitors.

6. The Contractor shall provide routine calibration services for those calibration procedures that are outside the scope of user responsibility.

Routine calibration services completed as required.

Meets 99% based on monthly data sheets.

Review of data sheets. COR Monitors

7. The Contractor shall provide all scheduled PM/Service within a 15 day window of due date.

Scheduled PM/Service completed as required.

Meets 95% based on monthly data sheets.

Review of data sheets. COR Monitors

8. The Contractor shall provide all material to verify analytical measurement range.

Provides materials for verification of analytical measurements range as required.

Meets - 100% Based on Finished Analytical Measurement Range Summary and Report

Review of reports.

COR Monitors

9. Packaging and temperature control requirements for all Reagents and Supplies.

Meets packaging and temperature controls as required.

Meets – 99% based on Each shipment of supplies and reagents.

Site may refuse shipment at Contractor’s return shipping or replacement cost if this requirement is not met.

Inspection upon receipt. COR Monitors

10. Instrument down-time due to maintenance issues or in-operability should not exceed 5%.

Response and solution for maintenance and emergency service as required.

Meets 99% based on monthly data sheets.

Review of reports.

COR Monitors

D. INFORMATION MANAGEMENT.

1. The Molecular Diagnostics instrument must be capable of bi-directionally interfacing with the Military Health System (MHS) LIS, i.e. MHS 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.

3. The analyzer system must be able to obtain an ATO to operate on the DHA network within 1 year following start of contract.

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. AT Awareness Training for Contractor Personnel Traveling Overseas. This standard language requires U.S.-based contractor employees and associated subcontractor employees to make available and to receive Government-provided area of responsibility (AOR) -specific AT awareness training as directed by DHA-AI 078. Specific AOR training content is directed by the combatant commander, with the unit ATO being the local point of contact.

4. 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.

5. The Contractor employees will NOT be required to attain a Common Access Card (CAC) or access to any government operated information system.

6. OPSEC Training is required. 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.

7. 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.

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 or with assistance from contractor personnel within a period to ensure that equipment is fully operational on or before September 30, 2025.

6. PLACE OF PERFORMANCE: Madigan Army Medical Center

Attn: Microbiology, Department of Pathology

Tacoma, WA 98431

7. PERIOD OF PERFORMANCE: 1 Oct 25 – 30 Sep 30) 5 year ordering period.

8. GOVERNMENT POINT OF CONTACT: Gibson, William, Supervisory Microbiologist, Department of Pathology, Madigan Army Medical Center.