Quality Management System (QMS) Software Subscription

THE PURPOSE OF THIS AMENDMENT IS TO:

1. POST Q&A.

2. CHANGE THE NUMBER OF LOCATIONS IN THE SALIENT CHARACTERISTICS.

3. REVISE TECHNICAL EXHIBIT 1- USER SITES. See the attachments for details.** The Medical Readiness Contracting Office-Europe has a requirement for a subscription to an online platform that has the ability to connect all compliance content – policies, procedures, training, assessments, non-conforming events, audits, and professional development in a single repository.

This online platform shall provide the structure for the Quality Management System in line with the accreditation and regulatory requirements of the College of American Pathologist (CAP), Association for the Advancement of Blood & Biotherapies (AABB), The Joint Commission (TJC), the Food and Drug Administration (FDA) 21 CFR Part 11 subpart B, the Code of Federal Regulations (CFR) Title 42, the Clinical Laboratory Improvement Amendments (CLIA), and the DoD Clinical Laboratory Improvement Program (CLIP) for the Landstuhl Regional Medical Center (LRMC) located in Landstuhl, Germany and additional user sites in the Technical Exhibit 1. The resultant contract type will be a Fixed-Price (FFP) with a base period plus four (4) one-year options.

See the attached 1449, Salient Characteristics and Technical Exhibit. Lowest Price Technically Acceptable (LPTA) source selection process will be used. All vendors must be registered in the System for Award Management (SAM) prior to response to the solicitation, and lack of registration shall make a quotation ineligible for award. Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov.