S02 - 36C10X25Q0093 - AAMI Subscription for VA.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

130-25-4-3728-0012

36C10X25Q0093 06-20-2025

Chris Binkley 832-260-2563 07-11-2025

15:00 EDT

36C10X Strategic Acquisition Center - Frederick Department of Veterans Affairs

5202 Presidents Court, Suite 103 Frederick MD 21703

X

813920

$23.5 Million

N/A

X

36C10X

Strategic Acquisition Center - Frederick Department of Veterans Affairs

5202 Presidents Court, Suite 103 Frederick MD 21703

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

(see Section B.1 invoicing/payment) Austin TX 78714-8917

1-(877)-489-6135

See CONTINUATION Page

HTM Professional Organization Institutional Membership & AAMI standards

Base Year Period of Performance is 9/19/2025 - 9/18/2026.

Questions are due by Jun 27th, 2025 @ 10:00 AM ET.

RFQ Response Due by Jul 11th, 2025 @ 10:00 AM ET.

Submit all questions and RFQ response to Chris Binkley @ Christopher.Binkley@va.gov

Contract Type: Firm Fixed Price

See CONTINUATION Page

X X

Chris Binkley Contracting Officer

36C10X25Q0093

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PERFORMANCE WORK STATEMENT (PWS)

B.3 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 38

C.5 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.7 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY

(FEB 2023)

C.8 VAAR 852.211-76 LIQUIDATED DAMAGES - REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023)

C.9 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.12 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899

(DEVIATION)(APR 2025)

C.13 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(Continuation from Standard Form 1449, block 18A.)

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: Association for the Advancement of Medical Instrumentation (AAMI)

POC: Insert POC Email: Insert email Phone: Insert Phone #

b. GOVERNMENT: Strategic Acquisition Center - Frederick Department of Veterans Affairs 5202 Presidents Court, Suite 103 Frederick MD 21703

Contracting Officer (CO): Chris Binkley Email: Christopher.Binkley@va.gov Phone: 832-260-2563

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System for Award Management

3. INVOICES: Invoices shall be submitted in arrears:

a. Other [X] Upon submission, review and acceptance by the Government.

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Contracting POC: Chris Binkley | Christopher.Binkley@va.gov | 832-260-2563 Contractor POC: Insert POC | email | Phone # Contracting Officer’s Representative (COR) POC: Shelley Leacock | Shelley.Leacock@va.gov | 314-346-8455

Contract Number: TBD Purchase Order Number: TBD

a. Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

b. Vendor e-invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

1. Tungsten e-Invoice Setup Information: 1-877-489-6135

2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

3. FSC e-Invoice Contact Information: 1-877-353-9791

4. FSC e-invoice email: vafsccshd@va.gov

See https://www.fsc.va.gov/einvoice.asp for more information.

FINAL INVOICE SHALL BE MARKED FINAL

http://www.x12.org/ https://www.fsc.va.gov/einvoice.asp

B.2 PERFORMANCE WORK STATEMENT (PWS)

1. Introduction

The Office of Healthcare Technology Management (HTM) requires a healthcare technology management professional organization institutional membership and 24/7 access to the most recently published version of all Association for the Advancement of Medical Instrumentation (AAMI) standards and guidance documents for all Veterans Health Administration (VHA) staff as well as 300 VHA HTM Job Postings for VHA HTM openings nationwide inclusive of the ability to join healthcare technology management professional organization Standards committees and workgroups that establish guidance and standards relating the medical equipment / clinical system management within and external to VHA.

This contract is necessary for ensuring VHA has quality processes and systems relating to HTM, Dialysis, and Sterile Processing that meet national and international standards as well as Food & Drug Administration (FDA) expectations for medical technologies. These standards are necessary tools to assist with administrative and operational responsibilities for VHA Biomedical Engineering, Sterile Processing and Dialysis professionals to ensure medical equipment management operations and comply with FDA and The Joint Commission standards for biomedical engineering, sterile processing, and dialysis technologies and protocols in support of quality healthcare and enhanced patient safety.

2. Scope

The contractor shall provide Biomedical Engineering, Sterile Processing, and Dialysis services inclusive of a subscription for an institutional membership with all membership benefits and services, access to the most current AAMI standards and guidance documents, and job postings for VHA’s Medical Device Safety Program through HTM. The contractor shall provide current and 24-hour access to pertinent information and tools to assist with administrative and operational responsibilities for VHA Biomedical Engineering staff including access to all AAMI standards and guidance documents as well as publications and periodicals, discussion boards, and the ability to join healthcare technology management professional organization committees and workgroups that establish guidance and standards relating the medical equipment / clinical system management within VHA.

Meetings shall occur quarterly.

3. Period of Performance

The period of performance for this order will be a base period of twelve months from the date of order award and four option periods consisting of twelve months each. Option periods shall be exercised at the discretion of the Government and upon availability of funding.

Base Period: 09/19/2025 to 09/18/2026 Option Year One: 09/19/2026 to 09/18/2027 Option Year Two: 09/19/2027 to 09/18/2028 Option Year Three: 09/19/2028 to 09/18/2029 Option Year Four: 09/19/2029 to 09/18/2030

4. Contract Type

This contract is Firm-Fixed Price (FFP).

5. Place of Performance

Tasks under this PWS shall be performed at the contractor facilities. Performance will be monitored by the Contracting Officer’s Representative (COR) at a government location, and only as directed by the Government. Work is to be performed remotely by the contractor at the contractor’s place of business.

The contractor provided web-based applications discussed in this requirement shall be accessible via standard web browsers with no plug-in requirements. The contractor’s servers shall have anti-virus software that is kept up to date.

6. Business Relations

The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timeliness, completeness, and quality of problem identification. The contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of personnel. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of contractor personnel. Contractor support shall be available during the hours of 8:00AM to 4:00 PM Monday through Friday, Eastern Time.

7. Contract Management

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single point of contact between the Government and contractor personnel assigned to support contracts or task orders.

Problem management and escalation will begin with the vendor’s Membership Department and may escalate up to and including the President and CEO.

8. Confidentiality and Nondisclosure

It is agreed that:

The CO will be the sole authorized official to release verbally or in writing any data, deliverables, and any other written or printed materials pertaining to this contract. No information shall be released by the contractor. Any request for information relating to this contract shall be submitted to the CO for response.

Press releases, marketing material or any other printed or electronic documentation related to this contract requirement shall not be publicized without the written approval of the COR and CO.

All data generated for and by VHA becomes the property of the Veterans Health Administration. In the event the relationship between VHA and the vendor is severed, all rights to the data remain with VHA.

9. Specific Tasks

9.1 Task 1: Healthcare Technology Management Professional Organization Institutional Membership. The contractor shall provide the Department of Veterans Affairs (VA) an Institutional membership to include an unlimited number of institutional representatives for health technology management (HTM) professionals from across the VA’s 170+ medical centers/health care systems and Biomedical Engineering offices as well as Sterile Processing, and Dialysis offices at the local, VISN and national levels. The Institutional membership shall include but not be limited to:

• Job search and resume posting inclusive of the contract costs.

• Online access to the healthcare technology management professional organization periodicals that are both newsletters oriented as well as peer reviewed publications.

Current and archived editions of these publications shall be available 24/7 to an unlimited number of VHA staff.

• Certification exams recertification processes for the AAMI Certification Institute (ACI) inclusive of the Certification exam for Biomedical Engineering Technicians (CBET) and the Certification exam for Healthcare Technology Management (CHTM).

• Opportunities to serve on AAMI Standards committees and working groups representing the VA to help develop global standards for medical devices and the HTM field.

• Opportunity to apply to serve on Standards and non-Standards committees to shape the future of the health technology field currently inclusive of but not limited to:

Artificial Intelligence Alarms Medical Device Alarms) Committee Anaesthetic and Respiratory Equipment Committee Anaesthetic Systems Working Group Airways and Related Equipment working group Respiratory devices and related equipment used for patient care working group Anaesthetic Terminology and Semantics working group Medical gas systems working group Suction Devices for Hospital and Emergency Care Working Group Attributes of Medical Devices Relevant to Biological Risk Assessment Blood/Gas Exchange Device Committee Blood Pressure Monitoring Committee Cochlear Implants Committee Small Bore Connectors Committee Luer Activated Valves Working Group Small Bore Connectors Reservoir Delivery Systems Working Group Cardiac Occluders Committee Combination Products Committee Defibrillator Committee NIS: Electrotechnical requirements & test methods ECG Committee Electromagnetic Compatibility Committee Medical Equipment Management Committee HTM Program Management Servicing Vocabulary Technology Acquisition Alternative Equipment Maintenance HTM Education Programs

Electrical Safety Committee Anesthesia Equipment Working Group Electroencephalographs Equipment Working Group EMG and Evoked Response Equipment Working Group optical Equipment Working Group Hospital Bed Working Group Clinical Thermometers Working Group Transcutaneous Partial Pressure Monitoring Equipment Working Group Ultrasound Working Group Lung Ventilators Working Group wave & Microwave Therapy Equipment Working Group Luminaires Working Group Lens Removal and Vitrectomy Devices Working Group WG 14 Photodynamic Therapy and Diagnostic Equipment Working Group Ionized gas coagulation equipment WG Human Factors Engineering Committee High Frequency Therapeutic Device Committee Health IT Committee Health IT Risk Management Working Group Health IT Quality Systems Working Group Health IT Usability Working Group Health IT Safety Working Group Infusion Device Committee Mechanical Circulatory Support Systems Committee Multiparameter Patient Monitoring Equipment Committee Transcutaneous Electrical Stimulator Working Group Cardiac Rhythm Management Device Committee Pacemaker and ICD MRI Compatibility Working Group Quality Management and Corresponding General Aspects for Products with a Health Purpose Including Medical Devices Application of Quality Systems to Medical Devices Working Group General Aspects Stemming from the Application of Quality Principles to Medical Devices Working Group Symbols & Nomenclature for Medical Devices Working Group Application of Risk Management to Medical Devices Working Group Application of post market surveillance systems to medical devices Good Engineering Maintenance Management Robotics Committee Software and Information Technology Committee Software Working Group Information Technology Networks Working Groups Interoperability Working Group Device Security Working Group Wireless Working Group Software Defect Classification Working Group

Cloud Computing Sphygmomanometer Committee Sterilization Standards Committee Industrial EO sterilization Working Group Radiation Sterilization Working Group Industrial Moist Heat Sterilization Working Group Biological Indicators Working Group Sterilization Terminology Working Group Chemical Indicators Working Group Packaging Working Group Microbiological Methods Working Group Aseptic Processing Working Group Liquid Chemical Sterilization Working Group General Criteria for Sterilization Processes and Sterilizing Equipment Working Group Instructions for Reusable Device Reprocessing Working Group Washer Disinfectors Working Group Sterility Assurance Level Vaporized Hydrogen Peroxide Sterilization Steam Sterilization Hospital Practices Working Group Dry Heat Sterilization Working Group Hospital Steam Sterilizer Working Group Steam Sterilization Dental Practices Processing of Tattoo Machines and Accessories in Healthcare Settings EO Sterilization Hospital Practices Working Group Chemical Sterilants Hospital Practices Working Group Hospital Ethylene Oxide Sterilizer Working Group Reusable Surgical Textiles Processing Working Group Endoscope Reprocessing Working Group Human Factors for Device Reprocessing Working Group Quality Systems for Device Reprocessing Working Group Resistometer Working Group Process Challenge Devices Working Group Cleaning of Reusable Medical Devices Working Group Rigid Sterilization Container Systems Working Group Water Quality for Reprocessing Medical Devices Working Group Compatibility of Materials Subject to Sterilization Working Group Sustainability Committee Cardiovascular Implants and Extracorporeal Systems Committee Active Implantable Medical Devices Committee Electrical Equipment in Medical Practice Committee Common aspects of electrical equipment used in medical practice Electromedical Equipment Committee Waveform Testing Committee

Opportunities to recognize VA staff through awards programs offered by the contractor.

Online membership services to help locate colleagues within and outside of the VA.

Administrative access for the COR or designee.

Meetings shall occur quarterly, unless lack of discussion topics warrants COR and CO to move meetings to bi-annually.

The contractor shall provide any applications from VA staff to become members of committees and working groups to HTM. HTM or designee shall approve members to committees and working groups to ensure that the contractor is working with the most qualified VA representatives on their committees and working groups. HTM will be given a period of 10 business days for concurrence with any applications.

Deliverables:

9.1.1 Institutional Membership for an unlimited number of VHA employees.

9.1.2 Electronic access to Healthcare Technology Management Professional Organization Publications inclusive of peer reviewed publications and newsletter oriented publications.

9.1.2 Meetings between contractor and HTM quarterly, unless lack of discussion topics warrants COR and CO to move meetings to bi-annually.

9.2 Task 2: AAMI Standards & Guidance Documents. The contractor shall provide the Department of Veterans Affairs access for all named users to access the most recent version of all AAMI Standards for 20 concurrent users as well as associated professional organization guidance documents. The AAMI Standards and guidance documents shall include but not be limited to:

• 24/7 online access to healthcare technology management professional organization guidance documents that include detailed and practical resources written by and expressly for biomedical equipment technicians, clinical engineers, and other medical technology professionals and offer guidance on topics ranging from preparing for a Joint Commission survey to troubleshooting equipment and benchmarking. Guidance documents on the following topics shall be included:

Career advice for health technology management (HTM) staff.

Management training.

Networked medical device guidance documents.

Cybersecurity guidance documents Best Practices and Lessons Learned.

Human Factors.

Home Healthcare devices.

• 24/7 online access to all AAMI national and international standards recognized by the FDA and The Joint Commission, recommended practices, technical information reports, and other resources covering sterilization, healthcare technology management dialysis, biological evaluation of medical devices, quality systems, and medical equipment currently inclusive of but not limited to:

Standard Developing Organization

Standard Designation Number Title of Standard

ANSI AAMI ISO 5356-1:2004

Anaesthetic and Respiratory Equipment - Conical Connectors

- Part 1: Cones and Sockets

ANSI AAMI ISO 5362:2006 Anaesthetic Reservoir Bags

ANSI AAMI ISO 10993-1: 2018

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ANSI AAMI ISO 10993-10:2010/(R)2014

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

ANSI AAMI ISO 10993-11: 2017

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

ANSI AAMI ISO 10993-12:2012

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

ANSI AAMI ISO 10993-13:2010/(R)2014

Biological evaluation of medical devices - Part 13:

Identification and quantification of degradation products from polymeric medical devices

ANSI AAMI ISO

10993-14:2001/(R)

Biological evaluation of medical devices - Part 14:

Identification and quantification of degradation products form ceramics

ANSI AAMI ISO 10993-17:2002/(R)2012

Biological evaluation of medical devices - Part 17:

Establishment of allowable limits for leachable substances

ANSI AAMI ISO 10993-2:2006/(R)2014

Biological Evaluation of medical devices - Part 2: Animal welfare requirements

ANSI AAMI ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity

ANSI AAMI ISO 10993-4: 2017

Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood

ANSI AAMI ISO 10993-5:2009/(R)2014

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ANSI AAMI ISO TIR 10993-20:2006

Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices

ANSI AAMI ISO 11658: 2012

Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems

ANSI AAMI ISO 14708-1:2014

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety marking and for information to be provided by the manufacturer

ANSI AAMI ISO 25539-1: 2017

Cardiovascular implants - Endovascular devices - Part 1:

Endovascular prostheses

ANSI AAMI ISO 25539-3:2011

Cardiovascular implants - Endovascular devices - Part 3:

Vena cava filters

ANSI AAMI ISO 27185:2012

Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Management Device Labels and Information to be Supplied -- General Requirements

ANSI AAMI ISO 27186:2010

Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements

ANSI AAMI IEC

60601-2- 25:2011/(R)2016

Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs

ANSI AAMI IEC

60601-2- 27:2011(R)2016

Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

ANSI AAMI IEC

60601-2- 4:2010/A1:2018 (Consolidated Text)

Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators including Amendment 1

ANSI AAMI IEC

60601-2- 47:2012/(R)2016

Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

ANSI AAMI ISO

7198:2016 Second edition

Cardiovascular implants and extracorporeal systems-- Vascular prostheses--Tubular vascular grafts and vascular patches

ANSI AAMI ISO 7199:2016

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).

ANSI AAMI IEC 80601-2-30:2018

Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers

ANSI AAMI ISO 81060-1:2007/(R)2013

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

ANSI AAMI BP22:1994 (R2016) Blood pressure transducers ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes ANSI AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires

ANSI AAMI EC57:2012

Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms

ANSI AAMI PC76:2021

Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging

AAMI TIR 41:2011/(R)2017

Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators

AAMI TIR42:2021

Evaluation of Particulates Associated with Vascular Medical Devices

ANSI AAMI CI86:2017

Cochlear implant systems: Requirements for safety functional verification labeling and reliability reporting

ANSI AAMI ISO 14971: 2019

Medical devices - Applications of risk management to medical devices

ANSI AAMI IEC

60601-1-8:2006 and A1:2012 [Including AMD 2:2021]

Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)]

ANSI AAMI IEC

62366-

1:2015+AMD1:2020

(Consolidated Text)

Medical devices Part 1: Application of usability engineering to medical devices including Amendment 1

ANSI AAMI ISO 80369-20:2015

Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

ANSI AAMI ISO 80369-5:2016

Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications

ANSI AAMI HE75:2009/(R)2018 Human factors engineering - Design of medical devices

AAMI TIR 49:2013/(R)2020

Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments

AAMI TIR66: 2017/(R)2020

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

ANSI AAMI IEC

60601-1-12:2016 [Including AMD 1:2021]

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)]

ANSI AAMI IEC

60601-1-2:2014 [Including AMD 1:2021]

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]

ANSI AAMI

ES60601-

1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons.

Text) [Incl. AMD2:2021]

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 MOD) [Including Amendment 2 (2021)]

ANSI AAMI

HA60601-1-11:2015

[Including AMD1:2021]

Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]

AAMI TIR69:2017/(R2020)

Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.

ANSI AAMI IEC 60601-2-2:2017

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

ANSI AAMI IEC 80601-2-77:2020

Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

ANSI AAMI CN27:2021

General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications

ANSI AAMI PB70:2012

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

ANSI AAMI PB70:2022

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

AAMI TIR101:2021 Fluid delivery performance testing for infusion pumps

AAMI TIR38:2019 Medical device safety assurance case guidance

AAMI NS28:1988/(R) 2015 Intracranial pressure monitoring devices ANSI AAMI NS4:2013(R)2017 Transcutaneous Electrical Nerve Stimulators

ANSI AAMI ISO 23500-1:2019

Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements

ANSI AAMI ISO 23500-2:2019

Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies

ANSI AAMI ISO 23500-3:2019

Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies

ANSI AAMI ISO 23500-4:2019

Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies

ANSI AAMI ISO 23500-5:2019

Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies

ANSI AAMI IEC 60601-2-16:2018

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis haemodiafiltration and haemofiltration equipment

ANSI AAMI ISO 8637-1:2017

Extracorporeal systems for blood purification -- Part 1:

Haemodialysers haemodiafilters haemofilters and haemoconcentrators

ANSI AAMI ISO 8637-2:2018

Extracorporeal systems for blood purification - Part 2:

Extracorporeal blood circuit for hemodialyzers hemodiafilters and hemofilters

ANSI AAMI ID54:1996/(R)2012 Enteral feeding set adapters and connectors

ANSI AAMI IEC 80601-2-58:2014

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]

AAMI RT2:2017 Radiation therapy readiness check AAMI RT3:2020 Radiation therapy machine characterization

ANSI AAMI 2700-1:2019

Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model

ANSI AAMI 2700-2-1:2022

Medical devices and medical systems - Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1:

Particular requirements for forensic data logging

ANSI AAMI UL 2800-1:2022 Standard for Medical Device Interoperability

ANSI AAMI UL 2800-1-1:2022

Standard for Risk Concerns for Interoperable Medical Products

ANSI AAMI UL 2800-1-2:2022 Standard for Interoperable Item Development Life Cycle

ANSI AAMI UL 2800-1-3:2022 Standard for Interoperable Item Integration Life Cycle

ANSI AAMI IEC 62304:2006/A1:2016

Medical device software - Software life cycle processes [Including Amendment 1 (2016)]

ANSI AAMI IEC 80001-1:2010

Application of risk management for IT Networks incorporating medical devices - Part 1: Roles responsibilities and activities

AAMI CR34971:2022

Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning

ANSI AAMI SW87:2012

Application of quality management system concepts to medical device data systems

ANSI AAMI SW91:2018 Classification of defects in health software

ANSI AAMI SW96:2023

Standard for medical device security - Security risk management for device manufacturers

AAMI TIR 36:2007 Validation of software for regulated processes

AAMI TIR 45:2012

Guidance on the use of AGILE practices in the development of medical device software

ANSI AAMI IEC TIR 80001-2-1 2012

Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples

ANSI AAMI IEC TIR 80001-2-2:2012

Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs risks and controls

ANSI AAMI IEC TIR 80001-2-3:2012

Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks

ANSI AAMI IEC TIR 80001-2-4:2012

Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations

ANSI AAMI ISO TIR 80001-2-6:2014

Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements

AAMI TIR57:2016 Principles for medical device security - Risk management.

ANSI AAMI IEC TIR80001-2-5:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

ANSI AAMI IEC TIR80002-1:2009

Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

AAMI TIR97:2019

Principles for medical device security - Postmarket risk management for device manufacturers

ANSI AAMI ISO 11135:2014/A1:2018

Sterilization of health-care products - Ethylene oxide - Requirements for the development validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E Single batch release

ANSI AAMI ISO 11137-1:2006/(R)2015

Sterilization of health care products - Radiation - Part 1:

Requirements for development validation and routine control of a sterilization process for medical devices [Including:

Amendment 1 (2013) and Amendment 2 (2019)]

ANSI AAMI ISO 11137-3:2017/(R)2023

Sterilization of health care products - Radiation - Part 3:

Guidance on dosimetric aspects of development validation and routine control

ANSI AAMI ISO 11138-1:2017

Sterilization of health care products - Biological indicators - Part 1: General requirements

ANSI AAMI ISO 11140-1:2014

Sterilization of health care products - Chemical indicators - Part 1: General requirements

ANSI AAMI ISO 11140-5:2007/(R)2012

Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs

ANSI AAMI ISO 11607-1:2019

Packaging for terminally sterilized medical devices - Part 1:

Requirements for materials sterile barrier systems and packaging systems

ANSI AAMI ISO 11607-2:2019

Packaging for terminally sterilized medical devices - Part 2:

Validation requirements for forming sealing and assembly processes

ANSI AAMI ISO 11737-2:2019

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition validation and maintenance of a sterilization process

ANSI AAMI ISO 13408-2:2018

Aseptic processing of health care products - Part 2:Sterilizing filtration

ANSI AAMI ISO 13408-3:2006/(R)2015

Aseptic processing of health care products - Part 3:

Lyophilization

ANSI AAMI ISO 13408-4:2005/(R)2014

Aseptic processing of health care products - Part 4: Clean-in-place technologies

ANSI AAMI ISO 13408-5:2006/(R)2015

Aseptic processing of health care products - Part 5:

Sterilization in place

ANSI AAMI ISO 13408-7:2012 (R2018)

Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products

ANSI AAMI ISO 14161-2009/(R)2014

Sterilization of health care products - Biological indicators:

Guidance for the selection use and interpretation of results

ANSI AAMI ISO 14937:2009/(R)2013

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development validation and routine control of a sterilization process for medical devices

ANSI AAMI ISO 15882:2008/(R)2013

Sterilization of health care products - Chemical indicators - Guidance for selection use and interpretation of results

ANSI AAMI ISO 17665-1:2006/(R)2013

Sterilization of health care products -- Moist heat -- Part 1:

Requirements for the development validation and routine control of a sterilization process for medical devices

ANSI AAMI ISO 20857:2010/(R)2015

(Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development validation and routine control of a sterilization process for medical devices

AAMI ANSI ST108:2023 Water for the processing of medical devices

ANSI AAMI ST24:1999/(R)2018

Automatic general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities 3ed.

ANSI AAMI ST40:2004/(R)2018

Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities

ANSI AAMI ST41:2008/(R)2018

Ethylene oxide sterilization in health care facilities: Safety and effectiveness

ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers AAMI ANSI ST55:2016/(R)2023 Table-top steam sterilizers

ANSI AAMI ST58:2013/(R)2018

Chemical sterilization and high-level disinfection in health care facilities

ANSI AAMI ST65:2008/(R)2018

Processing of reusable surgical textiles for use in health care facilities

ANSI AAMI ST67:2019

Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"

ANSI AAMI ST72:2019

Bacterial endotoxins - Test methods routine monitoring and alternatives to batch testing

ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization

ANSI AAMI

ST79:2017 & 2020

Amendments A1 A2 A3 A4

(Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities

ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers

ANSI AAMI ST91:2021

Flexible and semi-rigid endoscope processing in health care facilities

ANSI AAMI ST98:2022

Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices

ANSI AAMI ISO TIR 17665-2:2009

Sterilization of health care products - Moist heat - Part 2:

Guidance on the application of ISO ANSI/AAMI/ISO 17665-1

AAMI TIR104:2022

Guidance on transferring health care products between radiation sterilization sources

AAMI ISO TIR11137-4:2022

Sterilization of health care products - Radiation - Part 4:

Guidance on process control

AAMI TIR12:2020

Designing testing and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

ANSI AAMI ISO TIR16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

AAMI ISO TIR16775:2023

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization

AAMI TIR28:2016

Product adoption and process equivalence for ethylene oxide sterilization

• Documents shall be fully searchable 24/7.

• The contractor shall initially set up online access for VA members.

Deliverables

9.2.1 Healthcare Technology Management Professional Organization Guidance Documents for an unlimited number of VHA employees

9.1.2 AAMI Standards for an unlimited number of VHA employees

9.3 Task 3: Administrative support for adding / deleting VA institutional members for access to standards guidance documents.

Deliverables:

9.3.1 Administrative support for adding / deleting VA institutional members for access to standards and guidance documents within 10 business days of request.

9.4 Task 4: Job postings (300 pack / per year). This will allow VHA to post jobs available in VHA for Healthcare Technology Management / Biomedical Engineering via the contractor’s web site and email postings. VHA will receive access to all resumes in the contractor’s system as well. VA’s job postings will be emailed to all HTM / BME professionals in the contractor’s member database. This task will allow VHA to recruit and fill hard to recruit for positions of biomedical engineering support specialists and biomedical engineers.

Deliverables:

9.4.1 300 Job Postings

10. Deliverables Schedule

The contractor shall deliver documentation in electronic format, unless otherwise directed. All standards and guidance documents shall be able to be downloaded from the contractor’s website to pdf documents.

10.1 The following abbreviations are used in the delivery/deliverable schedule:

Abbreviation Definition CO Contracting Officer COR Contracting Officer's Representative CS Contract Specialist DA Days after DACA Days after contract award Days Calendar Days unless otherwise specified E Electronic Copy NLT Not Later Than NA Not Applicable PoP Period of Performance PWS Ref PWS Reference (paragraph number)

10.2 A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E).

Deliverable

PWS

Ref Title Qty Initial Subsequent

10.1.1 10.1

Healthcare Technology Management Professional Organization Institutional Membership for an unlimited number of VHA employees.

1 NLT 30

DACA

Constant for Contract Period of Performance

10.1.2 10.1

Electronic access to Healthcare Technology Management Professional Organization Publications inclusive of peer reviewed publications and newsletter oriented publications.

1 NLT 30

DACA

Constant for Contract Period of Performance

10.1.2 10.1 Meetings quarterly, unless lack of discussion topics warrants COR and CO to move meetings to bi-annually.

4 NLT 30

DACA

Every quarter or bi-annually as determined by COR and CO for the Contract Period of Performance

10.2.1 10.2

Healthcare Technology Management Professional Organization Guidance Documents for an unlimited number of VHA employees

1 NLT 30

DACA

Constant for Contract Period of Performance

10.2.2 10.2 AAMI Standards access for an unlimited number of VHA employees

1 NLT 30

DACA

Constant for Contract Period of Performance

10.3.1 10.3

Administrative support for adding / deleting VA institutional members for electronic access to the contractor’s membership sites within 10 business days of request.

1 NLT 30

DACA

Constant for Contract Period of Performance

10.4.1 10.4 Job Postings 300 NLT 30

DACA

Constant for Contract Period of Performance

11. Performance Requirements Summary

Performance standards define required performance for specific tasks. The Government performs surveillance to determine if the contractor exceeds, meets, or does not meet these standards. The Government may utilize other methods to compare contractor performance to the Acceptable Levels of Performance (ALPs).

11.1 Methods of Surveillance

Various methods exist to monitor performance. The COR shall use any or several of the surveillance methods listed below in the administration of this order.

11.1.1 Random Sample - The COR shall review a random sampling of the contractor’s performance/generated documentation and document results accordingly. This assessment shall be placed in the COR’s QA file. This sampling will consist of random searches for resources on the AAMI website and in the ARRAY tool as well as polling of VHA Biomedical Engineering departments to ensure that they are receiving the printed copies of publications and able to access online materials.

11.1.2 Validated Customer Complaint - Each year, the COR shall review the contractor’s performance/generated documentation corresponding to a validated customer complaint or validated inability to perform in accordance with tasks / deliverables. This assessment shall be placed in the COR’s QA file.

11.1.3 Frequency of Measurement

During task order performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed. At a minimum, performance shall be assessed yearly.

12. Documenting Performance

12.1 Acceptable Performance

The Government shall document acceptable performance in accordance with the tasks / deliverables above. Any report may become a part of the supporting documentation for any contractual action.

12.2 Unacceptable Performance

When unacceptable performance occurs, the COR shall inform the CO. This will always be in writing although when circumstances necessitate immediate verbal communication, that communication will be followed in writing. The COR shall document the discussion and place it in the COR file.

When the CO determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing to the CO. The CDR will state how long after receipt the contractor must take corrective action. The CDR will also specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CO shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

13. Security Requirements

The contractor shall not have access to any VHA systems. All tasks / deliverables shall be delivered via web-based tools, emails, and printed materials.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 YR __________________ __________________

Institutional Membership for an unlimited number of VHA employees.

Contract Period: Base POP Begin: 09-19-2025 POP End: 09-18-2026

AAMI Full Standards Collection on ARRAY for an unlimited number of

VHA employees.

Contract Period: Base

300.00 EA __________________ __________________

Job Posting with Job Flash.

Contract Period: Base

BASE YEAR TOTAL $

Contract Period: Option 1 POP Begin: 09-19-2026 POP End: 09-18-2027

VHA employees.

Contract Period: Option 1

Contract Period: Option 1

OPTION YEAR 1 TOTAL $

Contract Period: Option 2 POP Begin: 09-19-2027 POP End: 09-18-2028

AAMI Full Standards Collection on ARRAY for an unlimited number of VHA employees.

Contract Period: Option 2

Contract Period: Option 2

OPTION YEAR 2 TOTAL $

Contract Period: Option 3 POP Begin: 09-19-2028 POP End: 09-18-2029

VHA employees.

Contract Period: Option 3

Contract Period: Option 3

OPTION YEAR 3 TOTAL $

Contract Period: Option 4 POP Begin: 09-19-2029 POP End: 09-18-2030

VHA employees.

Contract Period: Option 4

Contract Period: Option 4

OPTION YEAR 4 TOTAL $

GRAND TOTAL $__________________

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1)…