Statement Of Work for Auto Serology.doc

Statement of Work Automated ID Serology Analyzer

1. TASK ORDER TITLE/DESCRIPTION OF SERVICE: The Department of Pathology is requesting a contract for reagents and instrumentation for running QuantiFERON TB-Gold Plus for the detection of M. tuberculosis immune responses by enzyme immunoassay (EIA), and MMRV IgG at Madigan Army Medical Center (MAMC). The system will include a direct from specimen, qualitative EIA analyzer with FDA-approved assays for QuantiFERON TB Gold Plus and MMRV IgG that is automated or semi-automated; workstation/laptop/CPU; and uninterruptable power supply. The system should be able to process multiple analytes simultaneously. The platform may not be limited to specified testing and may be expanded to include FDA-approved, EIA assays for Rubella IgM, CMV IgG/IgM, Toxoplasma IgG/IgM, HSV-1/2 IgG in the future depending on the patient testing needs at MAMC. Instrumentation and assays should perform serology assays 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 31st 2020. This contract shall be for 5 years (Base (1 Oct 20 – 30 Sep 21) + 4 one-year option periods), beginning October 1st 2020. Contractor access to JBLM is only required to perform mandatory maintenance or troubleshooting.

2. BACKGROUND: The Department of Pathology is currently testing QuantiFERON TB Gold-Plus utilizing a separate plate washer and reader that requires significant hands-on technician time. MAMC currently uses send-out testing for MMRV IgG assays. With expected increases in volume of testing for TB and consistently high volumes of MMRV send-out testing, the Serology Section requires an automated or semi-automated platform capable of performing FDA-approved infectious disease serology testing to meet patient testing needs, reduce staff time of running the assay manually, and improve TAT for clinical management by offering testing during a greater number of shifts.

3. OBJECTIVES AND SCOPE: To maintain the latest instrumentation to provide quality patient care for QuantiFERON TB Gold-Plus and MMRV serology testing in a timely manner. The platform may be expanded to include FDA-approved, EIA assays for Rubella IgM, CMV IgG/IgM, Toxoplasma IgG/IgM, HSV-1/2 IgG in the future depending on the patient testing needs at MAMC. 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 serology instrument (and associated reagents) capable of performing FDA-approved, enzyme immunoassays for infectious diseases. Specifically, the instrument MUST be able to run the QuantiFERON TB Gold-Plus assay for detection of M. tuberculosis immune responses. The proposal shall provide descriptive literature that meets the following specifications:

A. Functionality and Performance Specifications:

· Automated sample ID scanning and reagent ID scanning.

· Bar-coded data entry capabilities.

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

· Ability to receive approval for Authority to Operate (ATO) on Defense Health Agency (DHA) network within 1-year from start of contract and meet cyber security/network requirements.

· FDA-approved assays for:

· QuantiFERON TB Gold Plus

· Measles IgG

· Mumps IgG

· Rubella IgG

· VZV IgG

· Additional infectious disease serology assays may be added in the future to include:

· Rubella IgM

· CMV IgG/IgM

· Toxoplasma IgG/IgM

· HSV 1/2 IgG

· Preference will be given to platforms that have FDA-approved assays for the additional analytes specified.

· If a combined panel (e.g. MMRV, etc.) format is the only test format, must be able to do cost per reportable.

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

· Random access or the ability run multiple assays at the same time with the ability to process at least 10,000 specimens annually.

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

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

· Computer system (CPU, Monitor, Keyboard, Printer) with Custom Assay Protocol Files for Qiagen QuantiFERON TB Gold PLUS available, UPS for all instruments for the life of the instruments. Assay protocol files and results analysis/interpretation for other serology EIA/CLIA assays available through manufacturer or vendor for listed assays.

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

· Vendor will provide sufficient kits, at no cost to the Government, for verification of each assay as described in the verification plan signed by the Medical Director, Department of Pathology, Madigan Army Medical Center.

· Vendor will provide initial “operator level” on-site training at no additional cost to the government for 4 technicians.

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

· Must be able to run FDA-approved assays listed at a minimum, either supplied by vendor or by operating as open source system able to accommodate regents and tests from other manufacturers.

· Pipette tip locking and monitoring technology, including anti-droplet control (ADC) for reliable sample transfer. Disposable tips preferred. If system uses fixed tips, manufacturer must have completed a robust carry-over study or assist facility with design and completion of study.

· If available, external controls and/or calibrators for each assay should be included as part testing from the same manufacturer. Preference will be given to test assays that include external controls to meet requirements of Clinical Laboratory Improvements Acts of 1988.

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

· The systems must improve overall productivity in the Serology Lab, 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 once the run is started.

· Must require less than 1 h tech time for any pre-analytical processing steps or instrument/reagent preparation.

· Provide reliable technical support within 1 hr remotely during normal business hours and on-ground field service within 48 hours of system issues that cannot be resolved remotely.

· Any calculations for results interpretation for QuantiFERON TB Gold PLUS and other serological assays indicated are automatic (i.e. no manual manipulation of data or additional system hardware requirements) with direct reporting of results to LIS.

B. The contractor shall provide instrumentation that can perform the following FDA-approved, infectious disease serology testing capabilities:

· QuantiFERON TB Gold Plus

· Measles IgG

· Mumps IgG

· Rubella IgG/IgM

· VZV IgG

· CMV IgG/IgM

· Toxoplasma IgG/IgM

· HSV 1/2 IgG 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.

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.

E. 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 infectious disease serology 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 October 31, 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.

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