DDEAMC RMF New System Questionnaire.pdf
PDF 235 KB Posted
- Attached to
- Virology Molecular Testing
- Solicitation number
- W91YTZ20R0013
- Issued by
-
Department of the Army Medical Command
About this file
This document contains a pre-procurement assessment questionnaire for a medical device or system. It requests key technical configuration details such as operating system, database usage, security requirements, data handling practices, network and wireless connectivity specifications, and integration capabilities. It aims to determine compatibility with VA systems prior to acquisition. The related federal contract opportunity is for virology molecular testing services. The solicitation is from the Department of the Army Medical Command and seeks diagnostic testing support.
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Other files
| File | Type | Posted |
|---|---|---|
| Vendor Question and Answer.docx | DOCX document | |
| W91YTZ20R0013-COMBINED SYNOPSIS SOLICITATION.docx | DOCX document |
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Text version
*Equipment Category (Medical Device, Patform IT (PIT), Automation, General Service):
*Vendor:
*Requesting Service: *Model:
*Requestor: *Vendor Contact:
*Installation Location: (Dept, Bldg, Room):
*If server based, specify server name/type:
(virtual, hardware)
*Point of Contact: *Point of Contact Phone Number:
*Equipment Description (description of equipment function and systems it communicates with):
*Will IMD be responsible for configuration management,vulnerability management, and Security Technical Implementation Guide (STIG) compliance management for the hardware, firmware, or underlying system software: Yes No
If IMD is NOT responsible, please note the responsible department below:
DEPARTMENT OF THE ARMY
DWIGHT D. EISENHOWER ARMY MEDICAL CENTER (DDEAMC)
A&A RMF QUESTIONNAIRE
Software/Application Systems Information
What Operating System (OS) and version/Service Pack does the system utilize (Win 7 or 10, Win Svr 2008, 2012, or 2016)?
Does the system use a database application to operate? Yes No If yes, specify which database application and version:
Membership in the facility’s Windows Domain is:
Required Recommended Not Recommended N/A
Is a desktop web browser required to access the system/application? Yes No
If yes, specify which browsers and versions are supported:
If yes, does it require the use of https: and the Secure Socket Layer certificates – explain below:
If a browser is required, does it require a specific version of Java? Yes No If yes, specify the version:
Are there any software/hardware dependencies for operations? Yes No If yes, specify required dependencies:
If Windows based, can Configuration Management (CM) be used for for OS patches? Yes No
If no, specify how OS patching will be accomplished:
Can critical and routine OS and system security patches be applied as they become available without prior vendor approval? Yes No
If no, specify how approval notification to IMD will be accomplished:
Software or Application System Configuration
Can the device support the use of McAfee Anti-Virus (AV) software? Yes No If no, what AV packages and versions are supported and describe the mechanism to provide updates.
Can USB ports be disabled on the device without compromising operation? Yes No
Can auto run be disabled for portable media? Yes No Can host-based security components such as a firewall, host intrusion prevention system (HIPS), anti-malware software, and/or any other security suite software required to operate on EAMC LAN be installed without compromising operation?
Yes No
If “No” is the response to any of the above questions regarding updates and anti-virus software, please explain further for each item in the space below.
Is an administrator or power user account required to operate the device? Yes No
Can the device be made to require individual user authentication? Yes No Does the device support password aging and strong user password accounts? Yes No
Does the device support auto logoff or/and session lock? Yes No Does the system support the use of Active Directory for user authentication? Yes No
If yes, specify configuration requirements:
Does the system support the use of CAC/Smart Card only authentication? Yes No
Authentication and User Account
Specify which Electronic Protected Health Information (ePHI) data elements are stored on the device (first name, last name, SSN, DOB):
How many records with sensitive information can be stored on the device?
How long will they be retained on the device?
Is ePHI encrypted prior to transmission? Yes No If yes, what is the encryption mechanism(s)?
How is data transmitted to the storage repository (LAN, DVD, USB, etc.)?
Is ePHI stored only on a drive partition or a separate drive to assist with end-of-life media sanitization? Yes No
Will the medical device require data backups? Yes No If yes, specify how the system and data are backed up and what media is used:
Describe backup process: (data centers are lights out so this needs to be known up front)
Where will backups be stored and secured?
Does the device have the ability to assign unique ID numbers (accession numbers) instead of using patient identifying information?
Yes No
If yes, how is it generated?
Does the device utilize a laptop for system operation? Yes No If so, can the laptop be encrypted without impacting clinical functionality? Yes No
If yes, what encryption software can be used?
Data Handling
Provide a comprehensive list of all TCP and UDP ports that are required for operation:
Note: If more space is needed, please attach the comprehensive list of ports required for operation to this document. Attach a network diagram showing all communication requirements.
How many fixed/static IP addresses does the device require?
Is the device compatible with IP V6? Yes No Vendors’ products should be designed such that only ports required for the intended operation of the device are active. Are unused ports closed or disabled?
Yes No
Can this be accomplished without impacting system operation? Yes No Vendors’ products should be designed such that only services required for the intended operation of the device are active.
Are unused services (Telnet, IIS, FTP, etc.) disabled?
Yes No
Can this be accomplished without impacting system operation? Yes No Provide a comprehensive list of all services that are required for system operation:
Can the device be serviced remotely? Yes No Does the vendor have an existing Business to Business (B2B) VPN tunnel or individual user VPN account(s)? Yes No
What remote access software does the system utilize (Dameware, PC Anywhere, AD etc.)?
Does the device require connection to the Internet to operate? Yes No If yes, please justify and provide connection info (IP, port, protocol and traffic direction):
What are the LAN bandwidth requirements for full connectivity/performance?
What are the WAN bandwidth requirements for full connectivity/performance?
Networking
Does the device utilize wireless communication? Yes No
• If yes, what protocols are used?
Is the encryption module FIPS 140-2 certified. Provide certificate number if applicable:
Are any ePHI data elements transmitted via the wireless link? Yes No
• If yes, list each element (first name, last name, DOB, SSN).
Is this a new technology Yes No
Is software/application system compatible with Genesis and/or CHCS Yes No Has the software/application system been purchased? Yes No
Wireless
Software/Application System Acquisitions
If yes, identify how the purchased was performed (local/dept, DDEAMC, MEDCOM, DHA)
Prepared By:____________________ Company/Organization:_____________ Date:________
Is there an existing A&A package (current CON, ATO, etc) Yes No
Is the software/hardware Trusted Platform Manager (TPM) 2.0 certified Yes No
| Directive 6550 - February 2015 |
| PRE-PROCUREMENT ASSESSMENT FOR MEDICAL DEVICE/SYSTEMS |
| 3. RESPONSIBLE OFFICE. Veterans Health Administration (VHA) Office of Healthcare Technology Management (10NA9) is responsible for the material contained in this Directive. |
| 4. RELATED DIRECTIVE/HANDBOOK. VA Directive 6500, VA Handbook 6500, The Joint Commission Environment of Care Standard EC.02.04.01 EP1. |
| 3132015_80836AM_Directive 6550 - February 2015 |
| Directive 6550 - February 2015.pdf |
| Pre-Procurement Assessment Checklist_508 Compliance_v4 |
| VA Medical Equipment Pre-Procurement Assessment |
| Medical Device /System Configuration |
| Authentication and User Account |
| Pre-Procurement Assessment Checklist_508 Compliance_v4 |
| Data Handling |
| Networking |
| Wireless |
| Integration with VA Healthcare Information Systems |
| Signature Page |
Directive 6550 - February 2015
| Vendor: |
| Requesting Service: |
| Model: |
| Requestor: |
| Vendor Contact: |
| Installation Location: |
| Rack Space and Power Requirements: |
| Biomedical Engineering Point of Contact: |
| MDIA VLAN Number for Installation: |
| Equipment Description: |
| OS and Version Service Pack: |
| A-2 Checkboxes: |
| 0: |
| 0: Off |
| 1: Off |
| 1: |
| 0: Off |
| 1: Off |
| 2: |
| 0: Off |
| 1: Off |
| 3: |
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| 0: Off |
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| 5: |
| 0: Off |
| 1: Off |
| If yes specify which applicationversion: |
| Group1: Off |
| If yes specify which browsers and versions are supported: |
| If yes specify the version: |
| If no specify how OS patching will be accomplished: |
| A-3 Checkboxes: |
| 0: |
| 0: Off |
| 1: Off |
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| 0: Off |
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| 0: Off |
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| 9: |
| 0: Off |
| 1: Off |
| If no what AV packages and versions are supported and describe the mechanism to provide updates: |
| No anti-virus software: |
| If yes specify configuration requirements: |
| Specify which Electronic Protected Health Information ePHI data elements are stored on the device: |
| How many records with sensitive information can be stored on the device: |
| How long will they be retained on the device: |
| A-4 Checkboxes: |
| 0: |
| 0: Off |
| 1: Off |
| 1: |
| 0: Off |
| 1: Off |
| 2: |
| 0: Off |
| 1: Off |
| 3: |
| 0: Off |
| 1: Off |
| 4: |
| 0: Off |
| 1: Off |
| 5: |
| 0: Off |
| 1: Off |
| If yes what is the encryption mechanism: |
| How is data transmitted to the storage repository: |
| System and Data Backup: |
| Where will backups be stored and secured: |
| If yes how is it generated: |
| If yes what encryption software can be used: |
| What are the LAN bandwidth requirements for full connectivityperformance: |
| What are the WAN bandwidth requirements for full connectivityperformance: |
| TCF UDP Ports: |
| How many fixed IP addresses does the device require: |
| A-5 Checkboxes: |
| 0: |
| 0: Off |
| 1: Off |
| 1: |
| 0: Off |
| 1: Off |
| 2: |
| 0: Off |
| 1: Off |
| 3: |
| 0: Off |
| 1: Off |
| 4: |
| 0: Off |
| 1: Off |
| 5: |
| 0: Off |
| 1: Off |
| 6: |
| 0: Off |
| 1: Off |
| 7: |
| 0: Off |
| 1: Off |
| Provide a comprehensive list of all services that are required for system operation: |
| What remote access software does the system utilize: |
| If yes please justify and provide connection info IP port protocol and traffic direction: |
| A-6 Checkboxes: |
| 0: |
| 0: Off |
| 1: Off |
| 1: |
| 0: Off |
| 1: Off |
| 2: |
| 0: Off |
| 1: Off |
| 3: |
| 0: Off |
| 1: Off |
| 4: |
| 1: Off |
| 0: Off |
| If yes what protocols are used: |
| Certificate number: |
| If yes list each element: |
| List all other systems that the device will communicate with in order to operate properly: |
| Text3: |
| Responsible Party: |
| If yes does it require the use of https: |
| If no specify how approval notification will be accomplished: |
| Text1: |
| Check Box1: Off |
| Check Box2: Off |
| Check Box5: Off |
| Check Box6: Off |
| Check Box3: Off |
| Check Box4: Off |
File details come from the government source that posted it. Updated .