Title

The Scale People Inc. Preventative Maintenance Agreement for the Calibration of Various Instruments within the Center for Cellular Engineering (CCE) and the Department of Transfusion Medicine (DTM)

• Product Service Code: J066
• NAICS Code: 811210
• Place of Performance:

Bethesda, MD 20892 USA

POTS: 25-002098

Description

This is a notice of intent, NOT a request for a quotation. A solicitation document will NOT be issued, and quotations will NOT be requested.

The National Institutes of Health (NIH) intends to award a fixed-price purchase order to procure a preventive maintenance agreement from The Scale People Inc., located in Columbia, Maryland 21046-2849. The period of performance will be from February 10, 2025, to February 9, 2027.

The purpose of this acquisition is to procure a preventive maintenance agreement for the calibration of various equipment used in the Department of Transfusion Medicine.

The following services are required for this requirement: Preventive Maintenance (PM)

The contractor will provide scheduled preventive maintenance on an annual or semiannual basis, depending on the type of equipment, within the 12-month period. Maintenance will be scheduled by a qualified service representative, with the service date confirmed in advance of the scheduled due date.

Services to be performed on the following equipment:

1. Balances: Semiannual maintenance - Calibration/Certification, Standards Information, Final Status Report.
2. Microscopes: Annual maintenance - Cleaning of base, feet, stage plate, optical surfaces, set screws, knobs, lamp cover, objective lenses, and power cords for contamination. Lubrication as needed. Functional Test includes inspection of the base, feet, stage plate, zoom control, magnification lens, adjustment knobs, light bulbs, light switches, and power cords.
3. Pipettes: Semiannual calibration - As Found/As Left data, accuracy percentage, standards used, up to 10 check points (depending on pipette type), certification, and final status.
4. NIST Thermometers: Annual calibration - Standards, As Found, Min./Max. readings, and certification.
5. Tachometer: Annual service - Standards used, revolution per minute (optical), As Found, Min./Max./Final readings, and certification.
6. Stopwatch: Annual calibration - Standards used, As Found accuracy, and final certification.
7. Weights Verification: Regular service verification, including a Certificate of Verification after data calculations. Weight verification includes "As Found" readings only, no adjustments made, and pass/fail determination. Verification is recommended for all types of weights at least once a year by all manufacturers. A unique WV template designed for NIH will be used for all documentation.

****Please see the attached list of equipment for this action to be covered under this service agreement*****

The contractor is required to adjust or repair any item that does not meet the manufacturer's qualification criteria and provide detailed documentation of all work performed to the Department of Transfusion Medicine (DTM).

Preventive maintenance (PM) performed on these instruments is required to comply with the following regulations and standards:

• FDA 21 CFR 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
• FDA 21 CFR 606: Current Good Manufacturing Practice for Blood and Blood Components
• FDA 21 CFR 820: Quality System Regulation
• FDA 21 CFR 1271: Current Good Tissue Practices
• FDA Guideline for Quality Assurance in Blood Establishments, July 1995
• HCFA 42 CFR 493: Clinical Laboratory Improvement Act of 1988
• AABB Standards for Blood Banks and Transfusion Services
• AABB Standards for Cellular Therapy Product Services
• AABB Standards for Immunohematology Reference Labs
• ASHI Standards for Histocompatibility Testing
• JC Hospital Accreditation Standards
• AAHRPP Standards for Accrediting Human Research Protection Programs
• ACGME Common Program Requirements
• CAAHEP Standards and Guidelines

The Scale People Inc. is qualified by the Department of Transfusion Medicine (DTM) and meets all the aforementioned regulatory requirements to service the instruments currently in use within the Department of Transfusion Medicine.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation 13.501 Special documentation requirements for sole source acquisitions exceeding the Simplified Acquisition Threshold. Contracts awar