JA FAR Part 13 - HTM Prof Org and AAMI Standards.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FEDERAL ACQUISITION REGULATION

(FAR) 13.5

(1) Identification of the agency and contracting activity, and specific identification of the document as a “Sole Source Justification Under Simplified Procedures for Certain Commercial Items in Accordance with Federal Acquisition Regulation (FAR) 13.5.”

This sole source justification under simplified procedures for certain commercial items is executed by the Strategic Acquisition Center (SAC) – Frederick (SAC-F), on behalf of the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Office of Healthcare Technology Management (HTM).

(2) The nature and/or description of the action being approved, i.e., sole source under procedures for certain commercial items in accordance with FAR 13.5.

The Government proposes to issue a sole source, firm-fixed price (FFP) contract to the Advancement of Medical Instrumentation (AAMI), a non-profit organization, to provide support services through an HTM Professional Organization Institutional Membership with AAMI.

(3) A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The services provide by AAMI will include:

• Healthcare Technology Management (HTM) Professional Organization Institutional Membership

• AAMI standards and guidance documents for all VHA staff, and

• 300 HTM Professional Job Postings for an unlimited number of VHA staff.

This contract shall include one 12-month base period and four (4) 12-month option periods. The total value of this contract is estimated to be $425,053.00.

(4) The statutory authority permitting sole source.

The statutory authority permitting other than full and open competition is 41 U.S.C. § 1901, Simplified acquisition procedures implemented by Federal Acquisition Regulation (FAR) Subparts 13.106 and 13.501. In accordance with these subparts and 41 U.S.C. § 3304(e), this justification documents the circumstances of the contract action that deem only one source reasonably available (FAR 13.106-1(b)(1)(i)).

(5) A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring use of the authority.

AAMI institutional membership and standards provide a unique solution that is compatible with existing FDA and The Joint Commission standards and regulations. The VHA Office of Healthcare Technology Management technical representatives conducted market research, Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703 outlined in Section 6 below, to identify if other sources provide similar comprehensive healthcare technology management professional organization institutional membership and 24/7 access to the most recently published version of all AAMI standards and guidance documents. AAMI can meet the minimum requirements which are essential to the support of veteran patient care. The rationale for justification limiting competition to AAMI is a fact-specific analysis based on the totality of a confluence of significate issues related to VHA equipment life cycle management workflow and patient safety.

AAMI is the only source that publishes the material available in this VHA contract. AAMI is the only organization dedicated strictly to the advancement of medical equipment practices. They are the only known company that can provide both the membership to AAMI, HTM professional periodicals, and access to AAMI standards as well as targeted job postings to experienced professionals. VHA clinical and technical staff rely on the information and resources provided by the AAMI products and services to do their jobs and ensure that appropriate standards and regulations are met as required by The Joint Commission and FDA as well as certification programs, and recent relevant biomedical engineering topics.

The AAMI services and products contracted for will be used by all facilities and VACO program offices within VHA. The use of these highly specialized products and services is essential to the safety and efficacy of operations in the hospital environment of care. VHA relies on these products and services to ensure compliance with codes, standards, and regulations in many areas of the hospital including but not limited to dialysis, SPS, and Biomedical Engineering.

Accordingly, AAMI is the only firm capable of providing the products and services without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

(6) A description of efforts made to ensure offers/quotes are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by FAR 5.2 and, if not, which exception under 5.202 applies.

A notice of intent to sole source was issued on SAM.gov on 6/2/2025 and closed on 6/09/2025.

There were no responses to the notice.

This sole source justification will be published to SAM.gov no later than 14 days after the award.

(7) The anticipated dollar value of the proposed acquisition, including options if applicable, and a determination by the contracting officer that the anticipated cost to the government will be fair and reasonable.

No award shall be made until the Contracting Officer determines the cost to the Government to be fair and reasonable. This determination will be based on a comparison of current contract pricing, an Independent Government Cost Estimate, past proposal submissions (if available), and other information as made available.

https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

(8) A description of the market research conducted and the results or the reason market research was not conducted.

Details of the market research are as follows.

In accordance with VAAR 810.001-70, the Veteran Small Business Certification (VetCert), GSA e-Library, Dynamic Small Business Search (DSBS), System for Award Management (SAM), Federal Procurement Data System (FPDS), and Ability One website:

http://abilityone.gov.

were all queried.

The SBA Certification database (VetCert) contained zero results for “AAMI” or “Association for the Advancement of Medical Instrumentation”.

Another method used to conduct market research was to query the GSA eLibrary (http://www.gsaelibrary.gsa.gov/ElibMain/home.do). A query was performed using search criteria “AAMI” and which resulted in zero matches. A search of “Association for the Advancement of Medical Instrumentation” yielded zero relevant results. The products / services listed in the contract schedules under the GSA eLibrary do not meet the requirement.

The Dynamic Small Business Search (DSBS) under the Small Business Administration was used as well to research this requirement. Queries were performed using search criteria “AAMI” and “Association for the Advancement of Medical Instrumentation” yielded zero relevant results.

Previous procurement history was found on SAM.gov. Seven results were found; however, none of these results meet this requirement for a Healthcare Technology Management (HTM) Professional Organization Institutional Membership, AAMI standards and guidance documents for all VHA staff, and 300 HTM Professional Job Postings for an unlimited number of VHA staff.

Several prior federal contracts were found for similar services / products on the Federal Procurement Data System website. However, none of these are active contracts that fully meet the current need for this requirement.

Supplies or Services, which are on the Procurement List maintained by the Committee for Purchase from People Who Are Blind or Severely Disabled (see Subpart 8.7): Search of Ability One website: http://abilityone.gov through their services category for “AAMI” and “Association for the Advancement of Medical Instrumentation” resulted in zero results.

Literature was gathered by conducting internet searches. Some literature was provided by the firm which included produce brochures and sample reports.

Healthcare technology management service providers known to be used internal and external to VHA were reviewed as well to determine if they meet this requirement. AAMI is the only known provider that can meet all the requirements.

http://abilityone.gov/ http://www.gsaelibrary.gsa.gov/ElibMain/home.do) http://abilityone.gov/

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

AAMI is a global, independent authority on healthcare technology management and safety.

Their products and services help the healthcare community to improve quality, reduce cost, and achieve better outcomes across all care settings through a diverse group of members in both private and public sectors of healthcare. AAMI is the only known entity that publishes the AAMI standards necessary for ensuring VHA meets FDA and The Joint Commission regulations and standards. No other organization in the world has this combination of unique capabilities to advance cost-effective, safe healthcare across the continuum of care.

(9) Any other facts supporting the use of other than full and open competition.

AAMI was contacted via email during the market research phase to inquire on authorized SDVOSBs and VOSBs distributors of the web-based tools and resources required. It was verified that AAMI is the sole distributor and author of the AAMI web-based tools and resources and there are no authorized distributors.

(10) A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

Association for the Advancement of Medical Instrumentation (AAMI)901 N Glebe Road Suite #300, Arlington, VA 22203

POC: Melissa Bowhay, Senior Director, Membership Phone +1 703 253 8283 Email MBowhay@aami.org | www.aami.org

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

All future requirements will be handled on a case-by-case basis. Should it be determined that the Office of Healthcare Technology Management has a future requirement for this type of service, the Contracting Officer will conduct market research to determine if any business can provide this same service and consideration will be given as to whether the future acquisition should be competitive.

tel:+1%20703%20253%208283 mailto:MBowhay@aami.org https://gcc02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.aami.org%2F&data=05%7C02%7C%7C95362e12ae3b48cc658708dc94529785%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638548329693758174%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=yUX3p36QHjs5m%2F12ZJPDmwc69kBM77b64LbzmX4gKVA%3D&reserved=0

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

(12) Evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

I certify that the foregoing justification is complete and accurate to the best of my knowledge and belief.

Date: ____________ ________________________________ Shelly Leacock Contracting Officers Representative The Office of Healthcare Technology Management (HTM) Department of Veterans Affairs

(13) Contracting officer certification that the justification is accurate and complete to the best of the contracting officer ’s knowledge and belief.

I certify that this justification is accurate and complete to the best of my knowledge and belief.

As this action does not exceed $750,000, the certification below required by FAR 13.501(a)(2)(i) serves as approval.

_________________________________ Date: ____________ Chris Binkley Contracting Officer (CO) Strategic Acquisition Center