36C25525Q0122.docx

Sources Sought Notice

GENERAL INFORMATION

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

POINT OF CONTACT*

Contract Specialist Mark Socha mark.socha@va.gov 913-946-1992

PLACE OF PERFORMANCE

John Cochran

915 N. Grand Blvd

St. Louis MO

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Sources Sought Notice

GENERAL INFORMATION

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

POINT OF CONTACT*

Contract Specialist Mark Socha mark.socha@va.gov 913-946-1992

PLACE OF PERFORMANCE

John Cochran

915 N. Grand Blvd

St. Louis MO

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

Page 1 of

Sources Sought Notice

This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter into negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort.

The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract on the basis of this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice.

The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below.

Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below.

The VA Heartland Network 15, Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a potential qualified contractor to provide a COPAN Walkaway Specimen Processor for the St Louis VAMC, John Cochran MO VAMC, 915 N. Grand Blvd, St. Louis, MO 63106, that meet the specifications and high-quality threshold while integrating excellent stewardship, as found in the statement of work.

NAICS Code: 334516 (Analytical Laboratory Instrument Manufacturing)

Scope of Work – VA Saint Louis Health Care System

Objective The VA Saint Louis Health Care System intends to procure a COPAN Walkaway Specimen Processor (WASP) at John Cochran to replace the EOL unit already at the facility. This document highlights the technical specifications and services being requested by the facility for consideration towards purchase of the units. Vendors under this proposal shall provide all equipment and accessories, installation services, and project management support.

Equipment Specifications Requirements

· COPAN Walkaway Specimen Processor

· System weight < 1600 lbs

· Includes peripherals of touch screen monitor, external barcode reader, and label printer

· Custom streaking patterns

· Accept multiple media types/containers

· Accept multiple specimen types/containers

· Inoculate and spread calibrate volume of specimen at 1 uL and 30 uL

· Full sample traceability using uniquely barcoded disposable culture plates

· Remove & replace specimen lids/tops

· Include module to prepare slides for gram staining

· Shall not require cleaning material or decontamination beyond periodic maintenance

· Can be serviced/calibrated remotely

· Automatable tasks as needed by microbiology staff

· Attach to existing WASPLab track system to move from specimen processor to incubators

· System footprint fits within current lab layout and not require lab remodeling

System functionality

· The WASP must have the ability to connect to VISTA via Data Innovations and meet VA security requirements to remotely connect and service instrumentation. Instrumentation must include all upgrades, databases, etc included in initial purchase, and be capable of adding future advancements and additions to the lab system. Onsite vendor led training must be provided and include system operations as well as basic troubleshooting and repair. Unpacking and installation of the equipment by a technical expert (white-glove installation) is required. The contractor shall also provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and state-of-the-art technology at no additional charge after initial installation of the system. These must be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, including database upgrades, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc.

Software

· Vendor shall ensure all software operating on the device provided is supported by the original manufacturer at time of delivery.

· For example, vendor shall not provide VA Saint Louis a device utilizing the Windows XP or Windows 7 operating system as they are no longer Microsoft supported.

· Proprietary software systems are acceptable so long as vendor supports the version provided to VA Saint Louis and it is the newest version at time of delivery.

· Access to all software shall be provided to VA Saint Louis in situations where re-installation is necessary.

· Software shall be provided to VA Saint Louis with unlimited perpetual licensing for the supported life of the device.

· In cases where vendor insists on utilizing a licensing fee model this should be noted in the bid provided for VA Saint Louis consideration.

Network Security The vendor is required to fill out the five attached VA Security Forms if their equipment can be connected to the VA network. If these forms are not completed and submitted with the bid package the vendor can be disqualified from the bidding process.

Cerner Compatibility

· All vendors providing a bid to this requirement shall provide a Cerner compatibility statement from the OEM of the equipment that they are proposing to the VA Saint Louis Health Care System.

· This statement will include an OEM attestation that the product proposed is Cerner verified and provide a list of healthcare organizations that have deployed the project with the Cerner EHR.

· The statement will also include any relevant information as to what data can be transmitted to Cerner.

· This statement will be dated within 60 days of the quote being provided to ensure it is recent and accurate.

· The statement will provide an OEM point of contact who can be reached to further discuss any questions or concerns over Cerner compatibility.

· If the device/system being proposed does not connect to the network or medical record the vendor shall note this in their proposal.

· Vendor bids that do not include a Cerner compatibility statement directly from the OEM will be discarded from consideration.

Installation and Assembly

· Vendor shall be responsible for assembly and installation of systems after notification from VA Saint Louis Biomedical Engineering that it has been delivered to station.

· Installation shall include implementation and testing of all purchased interfaces to VA electronic systems in coordination with Clinical Staff, Biomedical Engineering staff, O&IT staff, and others identified as needed.

· Install shall include unboxing and transportation of equipment to final use location.

· Assembly and install shall occur within 30 days of delivery to station.

· Vendor shall provide all necessary accessories, cables, adaptors, etc. to deliver a fully functional clinical device.

Training

· Vendor shall provide on-site clinical/applications training for relevant VA Saint Louis staff members.

· Vendor shall provide introductory system/maintenance training to VA Saint Louis Biomedical Engineering staff during installation.

· Vendor shall include all costs for travel to provide this training in their proposal.

· Vendor shall coordinate all installation and training dates with VA Saint Louis specified Biomedical Engineering POC who will communicate internally with clinical staff.

Warranty and Service

· Service and Operator Manuals – The vendor shall provide the following documentation for the proposed system:

· Two (2) copies of operator's instruction manuals per unit purchased

· Two (2) copies of complete technical service manuals including detailed troubleshooting guides, necessary diagnostic software, service keys, schematic diagrams, parts lists, and any other resources available to the manufacturer’s service technicians.

· Two (2) copies of a system manager’s manual outlining back-up procedures, managing privilege group limits, routine tasks, etc.

· Warranty – The system, all accessories, and all software shall be covered under the manufacturer’s warranty and shall include all parts and labor for at least one year following acceptance by the VAMC.

· A manufacturer’s factory-trained Field Service Engineer shall perform installation and maintenance during the warranty period.

· The warranty period shall not begin until after the VA Saint Louis Biomedical Engineering POC has accepted the products delivery, installation, and functionality.

· The warranty shall include all manufacturer recommended Preventive Maintenance procedures for its duration.

· All available software updates and security patches will be made available to the VA Saint Louis during the warranty period.

· Vendor shall provide response to applications and technical calls within 8 hours.

· Vendor shall ship replacement parts within 48 hours of identifying necessity by VA Saint Louis Biomedical Engineering staff.

Other Features Value added features in the vendor’s proposal that will be considered include but are not limited to:

· Options for Trade-in of existing equipment shall be proposed in bid package

· Extended Warranty options shall be outlined in bid package

· Service and Biomedical training options shall be outlined in bid package

· Options for this training should include all registration, travel, and lodging costs when possible

Hours of Operation

· Normal hours of coverage are Monday through Friday, 7:00 AM to 3:30 PM Central Standard Time excluding national holidays.

· Vendor on-site visits will be coordinated with the VA Saint Louis Biomedical Engineering POC before being scheduled or conducted.

· Vendor representatives will check in with the VA Saint Louis Biomedical Engineering POC when they arrive on-site and check out upon completion of work each day.

· All services shall be performed during normal hours unless otherwise scheduled with the VA Saint Louis Biomedical Engineering POC.

· Vendor staff shall always be professional and shall take all necessary precautions to maintain a safe environment for the occupants. This includes, as necessary, coordinating access and closures for sensitive areas of the Medical Center.

· Vendor shall be responsible for cleaning all work areas after completion of tasks. This includes removal of packaging and a clean sweep/mop of the area as required by work type.

· Vendor staff shall minimize noise as much as possible while working in all buildings.

· Vendor is responsible for providing all PPE necessary for their work.

Note: Hardware/software update/upgrade installations, where applicable, may be scheduled and performed outside normal hours of coverage at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the VA Saint Louis Biomedical Engineering POC).

Federal Holidays observed by VA Saint Louis are:

Independence Day

Delivery

· Vendor shall deliver purchased equipment within 90 business days of receiving completed Contracting package from the VISN 15 Contracting Officer. If delivery delays occur vendor shall notify the Contracting Officer and the VA Saint Louis Biomedical Engineering POC.

· Delivery will be to one of the two VA Saint Louis Health Care System main campuses. Vendor shall coordinate exact delivery location with the Contracting Officer and VA Saint Louis Biomedical Engineering POC at the time of the purchase.

· Vendor will ensure that equipment is sent to the Attention of Biomedical Engineering and will include the VA Saint Louis PO Number on the shipping label.

· Delivery of oversized, palletized orders or orders that contain a large number of components will be coordinated with VA Saint Louis Biomedical Engineering POC who will communicate internally with Warehouse Staff.

VA Saint Louis Health Care System Delivery Locations

John Cochran 915 North Grand Blvd Saint Louis, MO 63106 ATTN: Equipment Committee PO Number for Order Jefferson Barracks 1 Jefferson Barracks Drive St. Louis, MO 63125 ATTN: Equipment Committee PO Number for Order

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1.includes VASTLHCS records.

2.does not include personal materials.

3.applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4.may include deliverables and documentation associated with deliverables.

C. Requirements

1.Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2.In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3.In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4.[Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, SOURCES SOUGHT NOTICE damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5.The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6.The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7.The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.

8.The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.

9.The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10.The [Agency] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [Agency] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11.Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown of requirements to subcontractors

1.The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2.Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

Sources Sought Notice image1.emf

VA 6550 A

VA DIRECTIVE 6550 Appendix A – To be completed for all procurements of network-connected medical devices and non-network-connected medical devices that store sensitive information. For client/server systems, a separate 6550 Appendix A is required for each the client and the medical server.

1.1 Equipment Category (VA-MDNS)

1.2 Manufacturer

1.3 Model

1.4 Application Name and Software Version #

1.5 Requesting Service

1.6 VISN

1.7 Facility Name

1.8 Facility Number

1.9 Manufacturer Point of Contact

Phone Number E-mail address

1.10 Biomedical Engineering Point of Contact

Phone Number E-mail address

1.11 Responsible Service if Biomedical Engineering is NOT the Primary System Manager for system maintenance, support and lifecycle management

1.12 Medical Device Type ☐ Discrete device ☐ Software

☐ Client ☐ Application server

1.13 Equipment Description (i.e. equipment function and systems it communicates with)

1.14 MDIA VLAN Number for installation (if known)

1.15 Installation Location (Room, Building, Division)

1.16 Is there an existing Enterprise Risk Analysis (ERA) for this device/system? ☐ Yes ☐ No

If yes, what is the ERA number?

**Note that the ERA must be for the same make, model, and application software version to apply to the requested system. A new ERA is required for major software or operating system updates (e.g. version 2.0 to 3.0) but is not required for minor updates (e.g. version 2.0 to version 2.1).

If an ERA exists for the requested system, completion of the 6550 Appendix A is not required beyond this point. Please sign to certify that an existing ERA is available for the requested system and forward the document to either the Area Manager or

ISSO for signature, as appropriate.

2.1 Device Operating System (OS)

Can the OS be automatically patched? ☐ Yes ☐ No **Note that systems that do not support automated patching via the VHA MD Update Server or via vendor channels impose a significantly higher risk to the VA network.

If patching is not automated, what is the patching process and/or limitations?

Procurement of systems with unsupported operating systems is prohibited. Unsupported operating systems are OSs that are not supported by the manufacturer and have reached the end of the OS lifecycle as published by the OS manufacturer (i.e. no further security patches will be released for the OS by the manufacturer after the OS end-of-life nor will be available by other methods such as extended warranty purchases from the OS manufacture).

2.2 Is the network connection wireless? ☐ Yes ☐ No

If yes, what is the FIPS 140-2 certification number?

Procurement of systems using 802.11 wireless networking that are not FIPS 140-2 compliant is prohibited.

2.3 Does the device include a database? ☐ Yes ☐ No

If yes, what is the database version?

2.4 Can the device run McAfee antivirus? ☐ Yes ☐ No

**Note that systems that do not support VA-approved antivirus scanning or an antivirus scanning solution managed by the vendor impose a significantly-higher risk to the VA network.

If antivirus is not supported, what are the AV processes and/or the limitations?

2.5 For Windows-based devices, can the VHA SMAK toolkit be installed? ☐ Yes ☐ No ☐ Non-Windows-based system

If no, has the vendor agreed to provide a complete software and application inventory for all system components as per FISMA requirements?

☐ Yes ☐ No

**Note that systems that do not support SMAK installation or for which the vendor does not agree to provide a complete software inventory impose a significantly higher risk to the VA network.

2.6 Does the system support the use of two-factor authentication (please review the VA’s requirements for two-factor authentication here)? ☐ Yes ☐ No

2.7 Is the device required to be joined to the VA domain? ☐ Yes ☐ No

2.8 Does the device allow for encryption of the data drive or OS drives? ☐ Yes ☐ No

2.9 Is sensitive data stored at rest on the device? ☐ Yes ☐ No

If yes, how many records can be stored on the device? ☐ <500 ☐ >500 If yes, does the device support on demand purging of data from the local hard drive? ☐ Yes ☐ No

2.10 Will sensitive data be stored outside of the VA network (e.g. cloud-based service provider – excludes Electronic Medical Record connection)? ☐ Yes ☐ No

2.11 Is connectivity external to the VA required for system operation? ☐ Yes ☐ No

2.12 Is connectivity external to the VA required for system support? ☐ No ☐ Yes - VA S2S VPN

☐ Yes – Other ☐ Yes - VA Citrix Describe remote access method and ports required if access is not via VA site-to-site VPN or VA Citrix.

2.13 How many IP addresses are required?

2.14 What kind of IPs does the system use? ☐ Static IP ☐ DHCP

**Systems should be deployed with static IPs unless DHCP is required.

2.15 If server-based, select one of the following: ☐ Vendor-provided physical server

☐ Vendor-provided virtual host ☐ Biomedical Engineering-provided physical server ☐ Biomedical Engineering-provided virtual host ☐ OIT-provided virtual host ☐ Other – describe

2.16 If server-based, list server specifications (cores, RAM, power, storage) and rack space.

2.17 Validate Cerner CareAware connection.

Submittal/Approval

Biomedical Engineering Date

Area Manager* Date

*Area manager signature only required for client/server medical systems. Please sign within 10 business days of receipt.

Information Systems Security Officer** Date

** Please sign within 5 business days of receipt and return the document to Biomedical Engineering and the Area Manager. If an ERA is required, please submit this form with the ERA package to the Specialized Device Security Division (SDSD) to initiate the ERA process.

https://vaww.oed.portal.va.gov/sites/vrm/IAM/playbooks/Pages/PIV%20Compliance/PIV%20Compliance.aspx

Manufacturer:

Model:

Application Name and Software Version:

Requesting Service:

VISN:

Facility Name:

Facility Number:

Manufacturer Point of Contact:

Phone Number:

Email address:

Biomedical Engineering Point of Contact:

Phone Number_2:

Email address_2:

Responsible Service if Biomedical Engineering is NOT the Primary System Manager for system maintenance support and lifecycle management:

Discrete device: Off

Client: Off

Software: Off

Application server: Off

Discrete device Software Client Application serverEquipment Description ie equipment function and systems it communicates with:

Discrete device Software Client Application serverMDIA VLAN Number for installation if known:

Discrete device Software Client Application serverInstallation Location Room Building Division:

undefined: Off

Yes NoIf yes what is the ERA number:

undefined_2: Off undefined_3: Off

If patching is not automated what is the patching process andor limitations:

undefined_4: Off

Yes NoIf yes what is the FIPS 1402 certification number:

undefined_5: Off

Yes NoIf yes what is the database version:

undefined_6: Off undefined_7: Off

If antivirus is not supported what are the AV processes andor the limitations:

No_4: Off

Yes_4: Off

NonWindowsbased system: Off undefined_8: Off undefined_9: Off undefined_10: Off undefined_11: Off undefined_12: Off undefined_13: Off undefined_14: Off undefined_15: Off undefined_16: Off undefined_17: Off undefined_18: Off undefined_19: Off undefined_20: Off undefined_21: Off undefined_22: Off undefined_23: Off undefined_24: Off undefined_25: Off

No_5: Off

Yes Other: Off

Yes VA S2S VPN: Off

Yes VA Citrix: Off

No Yes VA S2S VPN Yes Other Yes VA CitrixDescribe remote access method and ports required if access is not via VA sitetosite VPN or VA Citrix:

No Yes VA S2S VPN Yes Other Yes VA CitrixHow many IP addresses are required:

undefined_26: Off undefined_27: Off

Vendorprovided physical server: Off

Vendorprovided virtual host: Off

Biomedical Engineeringprovided: Off

Biomedical Engineeringprovided_2: Off

OITprovided virtual host: Off

Other describe: Off

Vendorprovided physical server Vendorprovided virtual host Biomedical Engineeringprovided physical server Biomedical Engineeringprovided virtual host OITprovided virtual host Other describeIf serverbased list server specifications cores RAM power storage and rack space:

Vendorprovided physical server Vendorprovided virtual host Biomedical Engineeringprovided physical server Biomedical Engineeringprovided virtual host OITprovided virtual host Other describeValidate Cerner CareAware connection:

Date:

Date_2:

Date_3:

Equipment Category (VA-MDNS):

Text6:

image2.emf

MDS2

HIMSS/NEMA Standard HN 1-2013

Manufacturer Disclosure Statement for Medical Device Security

Published by

National Electrical Manufacturers Association 1300 North 17th Street, Suite 900 Rosslyn, Virginia 22209 www.nema.org

© Copyright 2013 by the National Electrical Manufacturers Association and the Healthcare Information and Management Systems Society. All rights including translation into other languages, reserved under the Universal Copyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions.

© Copyright 2013 by the National Electrical Manufacturers Association and the Healthcare Information and Management Systems Society.

NOTICE AND DISCLAIMER

The information in this publication was considered technically sound by the consensus of persons engaged in the development and approval of the document at the time it was developed.

Consensus does not necessarily mean that there is unanimous agreement among every person participating in the development of this document.

The National Electrical Manufacturers Association (NEMA) standards and guideline publications, of which the document contained herein is one, are developed through a voluntary consensus standards development process. This process brings together volunteers and/or seeks out the views of persons who have an interest in the topic covered by this publication. While NEMA administers the process and establishes rules to promote fairness in the development of consensus, it does not write the document and it does not independently test, evaluate, or verify the accuracy or completeness of any information or the soundness of any judgments contained in its standards and guideline publications.

NEMA disclaims liability for any personal injury, property, or other damages of any nature whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, use of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, expressed or implied, as to the accuracy or completeness of any information published herein, and disclaims and makes no warranty that the information in this document will fulfill any of your particular purposes or needs. NEMA does not undertake to guarantee the performance of any individual manufacturer or seller’s products or services by virtue of this standard or guide.

In publishing and making this document available, NEMA is not undertaking to render professional or other services for or on behalf of any person or entity, nor is NEMA undertaking to perform any duty owed by any person or entity to someone else. Anyone using this document should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determining the exercise of reasonable care in any given circumstances. Information and other standards on the topic covered by this publication may be available from other sources, which the user may wish to consult for additional views or information not covered by this publication.

NEITHER THE HEALTHCARE INFORMATION AND MANAGEMENT SYSTEMS

SOCIETY (HIMSS) NOR NEMA HAVE POWER, NOR DO THEY UNDERTAKE

TO POLICE OR ENFORCE COMPLIANCE WITH THE CONTENTS OF THIS

DOCUMENT. NEITHER HIMSS NOR NEMA CERTIFY, TEST, OR INSPECT

PRODUCTS, DESIGNS, OR INSTALLATIONS FOR SAFETY OR HEALTH

PURPOSES. ANY CERTIFICATION OR OTHER STATEMENT OF

COMPLIANCE WITH ANY HEALTH OR SAFETY RELATED INFORMATION IN

THIS DOCUMENT SHALL NOT BE ATTRIBUTABLE TO HIMSS OR NEMA AND

IS SOLELY THE RESPONSIBILITY OF THE CERTIFIER OR MAKER OF THE

STATEMENT.

HN 1-2013

Page i

CONTENTS

FOREWORD ........................................................................................................... ii

CHANGES FROM PREVIOUS (2008) MDS2 REVISION ............................................... iv

Section 1 GENERAL

1.1 SCOPE

1.1.1 The Role of Healthcare Providers in the Security Management Process

1.1.2 The Role of Medical Device Manufacturers in the Security Management Process ...1

1.2 REFERENCES

1.3 DEFINITIONS

1.4 ACRONYMS

Section 2 INSTRUCTIONS FOR OBTAINING, USING, AND COMPLETING MDS2 FORM

2.1 OBTAINING THE MDS2 FORM (PROVIDERS)

2.2 USING THE MDS2 FORM (PROVIDERS)

2.2.1 Device Description

2.2.2 Explanatory notes

2.2.3 Security Capabilities

2.3 COMPLETING THE MDS2 FORM (MANUFACTURERS)

2.3.1 General

2.3.2 MDS2 Form Completion Guidance

Section 3 MDS2 FORM

Annex COMPARISON OF PREVIOUS (2008) AND CURRENT (2013) MDS2 (Informative)

Page ii

FOREWORD

This document consists of the Manufacturer Disclosure Statement for Medical Device Security (MDS2) form and related instructions how to complete the form. The intent of the MDS2 form is to supply healthcare providers with important information to assist them in assessing the vulnerability and risks associated with protecting private data transmitted or maintained by medical devices and systems. Because security risk assessment spans an entire organization, this document focuses on only those elements of the security risk assessment process associated with medical devices that maintain or transmit private data. A standardized form 1) allows manufacturers to quickly respond to a potentially large volume of information requests from providers regarding the security- related features of the medical devices they manufacture; and 2) facilitates the providers’ review of the large volume of security -related information supplied by the manufacturers.

The manufacturer-completed MDS2 should:

(1) Be useful to healthcare provider organizations worldwide. The information presented should be useful for any healthcare delivery organization that aspires to have an effective information security risk management program.

(2) Include device-specific information addressing the technical security-related attributes of the individual device model.

(3) Provide a simple, flexible way of collecting the technical, device-specific elements of the common/typical information needed by provider organizations (device users/operators) to begin medical device information security (i.e., confidentiality, integrity, availability) risk assessments.

HIMSS and NEMA grant permission to make copies and use this form.

PLEASE BE ADVISED—The MDS2 form is not intended to nor should it be used as the sole basis for medical device procurement. Writing procurement specifications requires a deeper and more extensive knowledge of security (including the individual facility’s/provider’s situation) and the healthcare mission.

Using the information provided by the manufacturer in the MDS2 form together with information collected about the care delivery environment (e.g., through tools such as ACCE, American College of Clinical Engineering/ECRI’s Guide for Information Security for Biomedical Technology), the provider’s multidisciplinary risk assessment team can review assembled information and make informed decisions on implementing a local security management plan.

This form was originally adapted from portions of the ACCE/ECRI Biomedical Equipment Survey Form, a key tool found in Information Security for Biomedical Technology: A HIPAA* Compliance Guide (ACCE/ECRI, 2004). This form was published originally in 2004, MDS2 v. 1.0 (2004-11-01) and then as a joint HIMSS/NEMA standard in 2008, HIMSS/NEMA Standard HN 1-2008.

*Health Insurance Portability and Accountability Act.

In 2010, International Electrotechnical Commission standard IEC 80001-1, Application of risk management for IT-networks incorporating medical devices, was published. The standard deals with the application of risk management to IT-networks incorporating medical devices and provides the roles, responsibilities and activities necessary for risk management. In 2012, a Technical Report (TR) supplement to IEC 80001 was published, IEC/TR 80001-2-2, Guidance for the communication of medical device security needs, risks and controls. In this supplement, 19 relevant security capabilities of a medical device or IT component are defined. The 19 high-level security capabilities are "...intended to be the starting point for a security-centric discussion

Page iii between vendor and purchaser or among a larger group of stakeholders involved in a Medical Device IT-Network project." Since this goal closely matches the primary objective of the MDS2 initiative, HIMSS and NEMA have undertaken an expansion and re-categorization of the MDS2 information provided by manufacturers in order to closely align with the 19 IEC/TR 80001-2-2 security categories.

HIMSS and NEMA recommend that the information in the MDS2 form be used as part of each organization’s security compliance and risk assessment efforts. In the preparation of this standards publication, input of users and other interested parties has been sought and evaluated.

Inquiries, comments, and proposed or recommended revisions should be submitted to the concerned NEMA product subdivision by contacting the:

Senior Technical Director, Operations National Electrical Manufacturers Association 1300 North 17th Street, Suite 900 Rosslyn, Virginia 22209

Page iv

CHANGES FROM PREVIOUS (2008) MDS2 REVISION

1) Alignment of MDS2 with International Electrotechnical Commission (IEC) standard 80001-1 supplement, IEC/TR 80001-2-2, Guidance for the communication of medical device security needs, risks and controls.

a) The order and numbering of the (2008) MDS2 questions has been changed and questions are now placed in either the MANAGEMENT OF PRIVATE DATA section or under the appropriate heading in one of the 19 categories in the SECURITY CAPABILITIES section of the MDS2 form.

b) The amount of MDS2 data requested of device manufacturers has been increased to more adequately address the 19 security capabilities of IEC/TR 80001-2-2.

c) MDS2 term definitions have been added or updated to be consistent with definitions used in IEC 80001 when applicable.

All of the MDS2 security-related questions of previous MDS2 revisions remain in this latest revision with no (or only minor) changes. A cross reference of the 2008 MDS2 questions vs.

2013 MDS2 questions is provided in the Annex.

2) De-localization

Several region-specific references and standards have been removed or replaced with more generic/less region-specific references. The term “Protected Health Information” (PHI), defined in USA HIPAA legislation has been replaced in this MDS2 revision by the term “private data,” as defined in IEC 80001.

Section 1

GENERAL

1.1 SCOPE

Information provided on the MDS2 form is intended to assist professionals responsible for security risk assessment processes in their management of medical device security issues. The information on the MDS2 form is not intended, and may be inappropriate, for other purposes.

1.1.1 The Role of Healthcare Providers in the Security Management Process

The provider organization has the ultimate responsibility for providing effective security management. Device manufacturers can assist providers in their security management programs by offering information describing:

• the type of data maintained/transmitted by the manufacturer’s device;

• how data is maintained/transmitted by the manufacturer’s device;

• any security-related features incorporated in the manufacturer’s device.

In order to effectively manage medical information security and comply with relevant regulations, healthcare providers must employ administrative, physical, and technical safeguards—most of which are extrinsic to the actual device.

1.1.2 The Role of Medical Device Manufacturers in the Security Management Process

The greatest impact manufacturers can have on medical device security is to incorporate technical safeguards (i.e., security features) in their devices to facilitate healthcare providers’ efforts in maintaining effective security programs and meeting any relevant regulatory requirements and/or standards. The medical device manufacturing industry is increasingly aware of the importance of having effective security functionality in their devices. Manufacturers are generally including such security-related requirements in the production of new devices based on provider needs and requirements.

1.2 REFERENCES

The following reference documents are included herein as suggested further reading, supportive material, and related publications:

Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities, IEC 80001-1:2010

Application of risk management...-- Part 2-1: Step by Step Risk Management of Medical IT- Networks; Practical Applications and Examples, IEC 80001-2-1:2012

Application of risk management...-- Part 2-2: Guidance for the communication of medical device security needs, risks and controls, IEC/TR 80001-2-2:2012

Health Insurance Portability and Accountability Act of 1996 (HIPAA), Pub. L. 104-191 (USA)

Health Insurance Reform: Security Standards; Final Rule, 45 CFR pts.160, 162, 164 (USA, 2003).

EC Data Protection Directive, 95/46/EC (EU 95/46), 1995.

Act on the Protection of Personal Information (Act No. 57 of 2003, Japan).

Personal Information Protection and Electronic Documents Act (PIPEDA), Statutes of Canada, 2000.

Guide for Information Security for Biomedical Technology: A HIPAA Compliance Guide, May 2004, American College of Clinical Engineering (ACCE)/ECRI.

1.3 DEFINITIONS

administrative safeguards: Administrative actions, policies, and procedures to manage the selection, development, implementation, and maintenance of security measures to protect private data and to manage the conduct of an organization’s workforce in relation to the protection of that information.

anti-malware: See anti-virus software.

anti-virus software: A program that monitors a computer or network to identify all major types of malware and prevent or contain malware incidents. See also virus scanner.

audit trail: Data collected and potentially used to facilitate a security audit.

biometric data: Identifies a human via a measurement of a physical feature or repeatable action of the individual (e.g., hand geometry, retinal scan, iris scan, fingerprint patterns, facial characteristics, DNA sequence characteristics, voice prints, handwritten signature).

device: A product/system, including hardware, firmware and/or (only) software, etc. Unless otherwise clear from the context, in this MDS2 document, “device” refers to the medical device (the manufacturer’s product) which is being addressed by the manufacturer in the MDS 2 form.

See also medical device.

electronic media: (1) Electronic storage media, including memory devices in computers (hard drives) and any removable/transportable digital memory media, such as magnetic tapes or disks, optical disks, or digital memory cards. (2) Transmission media used to exchange information already in electronic storage media, including, for example, the Internet (wide open), extranet (using Internet technology to link a business with information accessible only to collaborating parties), leased lines, dial-up lines, and private networks, and the physical movement of removable/transportable electronic storage media. Certain transmissions, including of paper via facsimile and of voice via telephone, are not considered to be transmissions via electronic media because the information being exchanged did not exist in electronic form before the transmission.

electronic protected health information (ePHI): (As defined in U.S. HIPAA legislation, 45 CFR 160.103) individually identifiable health information (IIHI) that is (1) transmitted by or (2) maintained in electronic media.

emergency access: The process or mechanism by which a device user can quickly and easily access private data in urgent (emergency) situations, bypassing the device’s established access controls.

individually identifiable health information (IIHI): Information that is a subset of health information, including demographic information collected from an individual, and: (1) Is created or received by a health care provider, health plan, employer, or health care clearinghouse; and (2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and (i) That identifies the individual; or (ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual.

intended use: Use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer. (source: ISO 14971:

2007, Application of risk management to medical devices, definition 2.5).

malware: Malicious software. A software program that is inserted into a system, usually covertly, with the intent of compromising the confidentiality, integrity, or availability of the victim’s data, applications, or operating system or of otherwise annoying or disrupting the victim. (source: NIST SP 800-83, Guide to Malware Incident Prevention and Handling) medical device: Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

– diagnosis, prevention, monitoring, treatment or alleviation of disease,

– diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

– investigation, replacement, modification, or support of the anatomy or of a physiological process,

– supporting or sustaining life,

– control of conception,

– disinfection of medical devices,

– providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;

b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

operator: Person handling equipment. The person(s) using a medical device for its intended purpose.

personal identification number (PIN): A number or code assigned to an individual and used to provide verification of identity.

physical safeguards: The physical measures, policies, and procedures to protect an organization’s electronic information systems and related buildings and equipment from natural and environmental hazards and unauthorized intrusion.

private data: Any information relating to an identified or identifiable person.

process: A set of inter-related or interacting activities which transforms inputs into outputs.

remote service: A support service (e.g., testing, diagnostics, software upgrades) while not physically or directly connected to the device (e.g., remote access via modem, network, Internet).

removable media: Electronic media that can be removed from a system without the use of tools.

risk assessment: Conducting an accurate and thorough analysis of the potential risks and vulnerabilities to the integrity, availability, and confidentiality of private data.

risk management: (1) The ongoing process of assessing risk, taking steps to reduce risk to an acceptable level, and maintaining that level of risk. (2) Security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level.

security capability: The broad category of technical, administrative or organizational controls to manage risks of confidentiality, integrity, and availability and…