HT942526R0000_MECs PM Repair of Sterilization and Central Vacuum Equip.pdf

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Preventative Maintenance and Repair of Sterilization and Central Vacuum Equipment in Biosafety Labs (BSL) 1, 2, 3 and 4
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HT942526R0000
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This document is a Minimum Essential Characteristics (MECs) for a service contract with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The contract requires preventative maintenance and repair of sterilization and central vacuum equipment across Biosafety Labs (BSL) 1, 2, 3, and 4, involving 63 total Getinge USA sterilizers, 3 cage washing units, 9 glassware washing units, and 3 tunnel washing units. The equipment spans multiple control systems and includes specialized double-door systems with proprietary ©Slideloc door assemblies.

Contractor personnel must meet stringent requirements, including U.S. citizenship, comprehensive knowledge of medical research laboratory standards (NFPA, CDC, NIH), successful completion of a Secret-level security background investigation, and enrollment in the Biological Personnel Reliability Program (BPRP). The scope of work includes on-site equipment repair, overhauling, inspection, and refurbishment, with mandatory bacteriological indicator testing after each maintenance session. All test equipment must be routinely calibrated, and contractors will assist USAMRIID's facilities management with water usage evaluation and utility system maintenance.

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Preventative Maintenance and Repair of Sterilization and Central Vacuum Equipment in Biosafety Labs (BSL) 1,2,3 and 4

Minimum Essential Characteristics (MECs)

This document outlines the requirement for a service contract to maintain and repair critical sterilization equipment, cage and glassware washing equipment, tunnel washers, and water treatment systems at the United States Army Medical Research Institute of Infectious Diseases

(USAMRIID).

Equipment Details:

• USAMRIID operates 49 Getinge USA sterilizers in building 1425, essential for neutralizing biological materials from BSL3 and BSL4 laboratories. An additional 14 units in building 8100 will require service within the next year, bringing the total number of units requiring service to 63.

• Other equipment in this contract includes the following: (3) three cage washing units, (9) nine glassware washing units, and (3) three tunnel washing units that require preventive maintenance and repair work as needed.

• These units are beyond life cycle, and the original equipment manufacturer (OEM) no longer provides repair parts for their control systems. The units in building 1425 are supported by an existing service contract. An upgrade of the control systems is required to support future preventive maintenance and repair services from the OEM.

• The control systems currently in use are: (15) MCII, (14) PACS 3000, (26) PACS 3500, and (12) Miscellaneous control systems not previously mentioned (Allen, Vivus, B&R, Steris system III, Yokagowa). These control systems were commercially available for bulk sterilization equipment from 2007-2021.

• USAMRIID also utilizes double-door systems equipped with the proprietary ©Slideloc door assembly. Expertise in the function of this door assembly is mandatory.

• In addition, there are three (3) custom built Getinge autoclaves currently in use.

Scope of Work:

The service contract shall encompass the following:

• Repair and overhaul of equipment including receiving inspection, disassembly, inspection, refurbishment, reassembly, packaging, preservation, and the provision of all required materials and consumables as specified in the component maintenance manuals.

Consumable items include, but are not limited to, nuts, bolts, washers, packing, dust boots, seals, paint, primer, preservation oil, hydraulic fluid, and sealant.

• All work must be performed on-site at the equipment's location.

• Equipment service must adhere to OEM specifications. A bacteriological indicator test will be performed to verify the equipment's efficacy after each repair and periodic preventive maintenance, in accordance with established protocols.

• All test equipment used in the performance of this contract must be routinely calibrated, with calibration traceable to a nationally recognized equipment/industry standard.

• All required tools and test measurements and diagnostic tools necessary must be provided by the contractor.

• Contractors will assist facilities management branch of USAMRIID in evaluation of water usage to the effluent decontamination system and conduct utility system shutdowns for system wide maintenance and emergencies.

Personnel Requirements:

The contractor's personnel must meet the following requirements:

• Possess comprehensive knowledge of applicable codes, standards, directives, and criteria governing the operation, maintenance, and repair of medical research laboratories including but not limited to the National Fire Protection Association (NFPA), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) including the Biosafety in Microbiological and Biomedical Laboratories (BMBL).

• Be United States citizens.

• Be able to successfully enroll in the Biological Personnel Reliability Program (BPRP) which includes medical screening and the requirement to wear respiratory protection and other personal protection equipment.

• Have successfully completed a security background investigation at the eligibility level of Secret at the start of the contract and may have to register with the Department of Health and Human Services (HHS) through the USAMRIID BPRP Program to work in USAMRIID areas used for select agents and toxins.

• All unescorted personnel entering containment suites must be enrolled in the Biological Personnel Reliability Program (BPRP).

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