SOW_Nucleic Acid Amplification Test.DOC

Statement of Work STI Molecular NAAT

1. TASK ORDER TITLE/DESCRIPTION OF SERVICE: The Department of Pathology is requesting a contract for reagents and instrumentation for the detection of Chlamydia trachomatis, Neisseria gonorrhea, and Mycoplasma genitalium at Madigan Army Medical Center (MAMC). The system will include an automated, random-access nucleic acid testing analyzer with FDA-approved assays for C. trachomatis, N. gonorrhea, and M. genitalium; workstation with LCD touchscreen; uninterruptable power supply; and vacuum pump. Due to the high volume of this testing, two systems will be part of the contract to ensure uninterrupted patient care during downtime and/or maintenance requirements of the system. The platform may not be limited to C. trachomatis, N. gonorrhea, and M. genitalium 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 October 1st 2020. Period of Performance is 12 month base (1 Oct 20 – 30 Sep 21) with 4 one-year option periods (if exercised). Contractor access to JBLM is only required to perform mandatory maintenance or troubleshooting.

2. BACKGROUND: An FDA-approved M. genitalium assay run at MAMC is preferred in order to recapture costs from send-out testing, provide better patient care with an FDA-approved test over the current lab developed test (LDT) send-out, and improve TAT for providers for clinical management of sexually transmitted infections (STI).

3. OBJECTIVES AND SCOPE: To maintain the latest instrumentation to provide quality patient care for C. trachomatis, N. gonorrhea, and M. genitalium testing in a timely manner. The platform may be expanded to include amplification-based molecular testing for other pathogens. 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 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) and reagents capable of performing FDA-approved C. trachomatis, N. gonorrhea, and M. genitalium testing with specific functionality and performance-based requirements of the system. The proposal shall provide descriptive literature that meets the following specifications:

A. Functionality and Technical Specifications:

· Must be capable of processing up to 275 samples in an 8 hour shift.

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

· Must accept primary collection container on system without requirement for manual pre-analytical processing.

· Bar-coded data entry capabilities.

· Must process Liquid Level detection capability to confirm adequate sample and reagent levels.

· Must be able to process Urine and Swab specimens, and have FDA-approval for both specimen types.

· 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.

· Test-specific reagents with at least 3 month expiration at delivery.

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

· Effective dimensions for individual analyzer must be no greater than 69 in x 36 in x 72 in to include clearances and accessory equipment (i.e. printer).

· Deliver first result in 3.5 hours or less.

· Must process at least 100 results per hour following first result.

· Must be random access to allow multiple assays to be run simultaneously and continuously with the ability to process at least 55,000 tests annually.

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

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

· Computer system (CPU, Monitor with touch screen, 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 15-32°C and <80% relative humidity.

· The test(s) specifically identifies C. trachomatis, N. gonorrhea, and M. genitalium at clinically relevant infection levels.

· The systems must improve overall productivity in the Microbiology Section, reducing the need for repeat testing thus reducing reagent waste.

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

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

· Overnight operation capabilities from start of specimen to finish.

· 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.

B. 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.

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

5. OPSEC Training is required. Per AR 350-1, Operations Security, new contractor employees must completed Level 1 OPSEC training within 30 calendar days of their reporting for duty. All contractor employees must complete annual OPSEC awareness training.

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 of time to ensure that equipment is fully operational on or before September 30, 2020.

6. PLACE OF PERFORMANCE: Madigan Army Medical Center

Attn: Anatomic Pathology, Department of Pathology

Tacoma, WA 98431

7. PERIOD OF PERFORMANCE: Base (1 Oct 20 – 30 Sep 21) + 4 one-year option periods (If exercised).

8. GOVERNMENT POINT OF CONTACT: MAJ Stacey L. Bateman, OIC Immunology & Molecular Diagnostics, Department of Pathology, Madigan Army Medical Center.