Quality Management System (QMS) Software Subscription

Closed Solicitation Posted

Solicitation number
W9114F-25-Q-A006
Agency
Medical Command Department of the Army, Department of Defense
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
513210 Software Publishers
PSC
7A20 It And Telecom - Application Development Software (Perpetual License Software)
Place of performance
Rhineland-Palatinate 66849 Germany
Points of contact

Notice details come from SAM.gov. Updated .

About this opportunity

The Medical Readiness Contracting Office-Europe is seeking a subscription to an online Quality Management System (QMS) software platform for the Landstuhl Regional Medical Center and 24 additional user sites across Europe. The Department of the Army Medical Command requires a comprehensive system that can integrate compliance content including policies, procedures, training, assessments, non-conforming events, audits, and professional development into a single repository. The software must meet accreditation and regulatory requirements from multiple organizations, including the College of American Pathologists, The Joint Commission, FDA, and Clinical Laboratory Improvement Amendments. The solicitation will use a Lowest Price Technically Acceptable (LPTA) source selection process, and all vendors must be registered in the System for Award Management (SAM) prior to submitting a response. Proposals are due by December 20, 2024, with the contract awarded as a Fixed-Price (FFP) arrangement featuring a base period and four one-year option periods.

The solicitation is not set aside for any specific business type, though the previous amendment referenced Women-Owned Small Business participation. The QMS software will support up to 850 users across 25 sites located in Germany, Italy, United Kingdom, Belgium, Spain, Turkey, and Bahrain, with the primary location being the Landstuhl Regional Medical Center in Kindsbach, Germany. The system must provide capabilities including document control, electronic signatures, inspection management, competency assessments, event tracking, personnel documentation, continuing education, and licensing exam simulators. Technical requirements specify capabilities such as P.A.C.E.-approved course content, 80 hours of training material, exam simulators for 20 seats, and clinical case simulators for up to 150 seats. The software must be vendor-hosted, cloud-based, and capable of managing tens of thousands of documents with retention periods up to 10 years or longer.

Notice text

2 versions

Update #2 · Latest ·

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.

Update #1 ·

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.

Attachments

Files attached to this notice, newest first
File Type Posted
Technical Exhibit 1 - User Sites_v2_13DEC24.xlsx XLSX spreadsheet
Salient Characteristics - No. Sites_v2_13DEC24.docx DOCX document
Amendment 1 - QnA_13DEC24.docx DOCX document
Amendment W9114F25QA006-0001.pdf PDF
Salient Characteristics.docx DOCX document
B.08 Solicitation - W9114F25QA006.pdf PDF
B.08 Technical Exhibit 1 - User Sites.xlsx XLSX spreadsheet

Notice history

Notices posted for this opportunity, newest first
Notice Type Posted
Quality Management System (QMS) Software Subscription This notice · Latest solicitation Solicitation
Quality Management System (QMS) Software Subscription Original Pre-Solicitation

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