BioMerieux Statement of Work_DRAFT.pdf

Statement of Work

1. Task Order Title/Description of Service: The Madigan Army Medical Center Department of Pathology Microbiology Laboratory provides diagnostic laboratory testing for infectious disease. The Microbiology Laboratory requires a suite of FDA approved instrumentation and reagents capable of performing the following. Fully automated extraction of nucleic acids, DNA and RNA, from either pure culture or direct from specimen. Automated system for loading and monitoring culture bottles for growth of organisms in patient blood or body fluid specimens. Identification of bacterial, mycobacteria and fungal targets using Matrix-Assisted Laser Desorption/Ionization Time of Flight (MALDI-ToF) technology. Automated biochemical identification and antimicrobial susceptibility testing of Gram positive and Gram-negative organisms isolated from patient specimens. Contractor must provide all equipment, consumables, supplies, controls, and calibrators. 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 reportable patient results on or before October 01, 2023. This contract shall be for 1 base year and two 1-year option periods, beginning October 1, 2023. Contractor must also follow any requirements dictated by the AT/OPSEC Standard Contract Provision.

2. Background: The contract that fulfills this requirement is set to expire on 30 September 2023. This facility requires a replacement contract that provides state of the art, high speed, and total nucleic acid extraction of biological samples. Identification of bacterial and fungal isolates and susceptibility testing of Gram positive and Gram-negative bacteria.

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 and/or method comparison with current equipment.

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 trouble shooting 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 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 analyzer. Contractor shall provide an itemized list of components to include make, model, and serial number of each component for property accountability purposes. 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: NONE

5. Specific Tasks:

A. The following are salient characteristics and specifications for the molecular diagnostic reagents supply that we are requesting:

a) Mass Spec:

Must offer an FDA approved library for bacteria, and yeast as well as mycobacteria that includes M. tuberculosis and clinically relevant non-tuberculous mycobacteria.

Walkaway functionality that requires no further technician time once the analyzer has started until it is complete.

The instrument must be able to process minimum of 100 individual specimens in an 8-hr. shift.

The assay must include QC requirements in accordance with our accrediting bodies.

Consumables should be scalable and able to be used in small or large sample run sizes.

Instrument must be able to interface bi-directionally with MHS-Genesis, the laboratory information system.

The system must provide a species ID and evaluation of the strength of the identification.

b) Automated ID and AST System:

System must be able to identify clinically relevant Gram-positive, Gram-negative organisms and Yeast.

Identification must include an evaluation of the confidence of the identification.

Antimicrobial susceptibility testing (AST) of Gram positive and Gram-negative organisms must follow guidelines set forth in the Clinical Laboratory Standards Institute.

System software must apply standard rules (e.g., intrinsic resistance, flagging of potential Extended Spectrum Beta Lactamase producers).

System software must allow for customized reporting rules based on institution specific reporting requirements.

Random access loading of specimens for identification and AST.

Instrument must be able to interface bi-directionally with MHS-Genesis, the laboratory information system.

c) Nucleic Acid Extraction System:

System must have FDA IVD approved reagents and processes for the extraction of nucleic acids from various biological sources.

System must be capable of process more than twelve specimens at a time.

Walkaway functionality that requires no further technician time once the machine has started until it is complete.

System must be able to extract and elute into from various volumes.

System must be considered/approved for Center for Disease Control Emergency

Use Authorizations.

d) Automated Broth incubation and growth detection System:

System must have FDA IVD approved reagents specific for the recovery of mycobacterium.

System must be able to hold an incubation temperature of approximately 37 degrees Celsius (optimal temperature for growth of most clinically significant mycobacterium).

System must have around the clock monitoring of growth indicated and signal/alarm positive results.

System must be able to perform self-calibration at defined intervals.

e) Automated Blood and Body fluid specimen incubation and growth detection System:

System must have FDA IVD approved reagents specific for the recovery of organisms from Blood and Body fluid specimen.

System must be able to hold an incubation temperature of approximately 37 degrees Celsius.

System must have around the clock monitoring of growth indicated and signal/alarm positive results.

System must be able to perform self-calibration.

System must be able to load Blood and Body fluid culture bottles automatically.

System must be able to measure volume of Blood and Body fluid patient specimen in culture bottles automatically.

B. The Contractor shall provide reagents with a shelf life of not less than 90 days from time of receipt.

C. AT Level I Training. This provision/contract text is for contractor employees with an area of performance within an Army controlled installation, facility or area. All contractor employees, to include subcontractor employees, requiring access Army installations, 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. 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 30 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website:

https://atlevel1.dtic.mil/at.

D. Access and General Protection/Security Policy and Procedures. This standard language text is for contractor employees with an area of performance within an Army controlled installation, facility or area. Contractor and all associated sub-contractors employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The contractor shall also 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 as directed by DOD, HQDA 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.

E. OPSEC Training is required. Per AR 530-1, Operations Security, new contractor employees must complete Level 1 OPSEC training within 30 calendar days of their reporting for duty. All contractor employees must complete annual OPSEC awareness training.

6. Place of Performance: Madigan Army Medical Center Attn: Microbiology, Department of Pathology Tacoma, WA 98431

7. Period of Performance: 01 October 2023 to 30 September 2025.