New Medical Devices
From VHA-V02-HTM-POL-00202 Acquisition of Medical Equipment: Fill in the Blank
It is the policy of the VISN 2 Healthcare Technology Management to support the provision of state of the-art healthcare technology that will reliably perform by the standards of the VISN 2 _____ _____ ______ ______ (XXXX), secure patient information, and perform in the most efficient manner governing the technology at current standards of performance and patient safety.
Medical Equipment Management Program (MEMP)
From VHA-V02-BME-POL-00302 PM_Documentation of PM procedures
Preventative maintenance procedures are to be based on ____ recommendations unless otherwise noted:
A. The Joint Commission
B. Manufacturer
C. Lead Bess'
D. Gary's
B. Manufacturer
From VHA-V02-HTM-POL-00701 Emergency and Safety_Electrical Safety
It is the responsibility of the HTM Service Line Authorized Testing Personnel to ensure that testing devices have been tested and calibrated within What Time frame?
A. one Week
B. one Month
C. one Year
D. Never
C. one Year
From VHA-V02-HTM-POL-00903 Performance Improvement EOC
It is the policy of the VISN 2 Healthcare Technology Management Service Line (HTMSL) to report standard TJC and other Medical Equipment Quality Assurance data to the EOC Committee quarterly.
What do the acronyms TJC and EOC stand for?
TJC - The Joint Commision; an independent, private, fee-based, commission that improves the quality of health care provided to the public through the annul issuance of standards.
EOC - Environment of Care
From VHA-V02-HTM-POL-00606 Networked Medical Systems_Removable media Scanning
It is the policy of the VISN 2 HTM (Healthcare Technology Management) Service Line to perform ___ on all removable media prior to use on VA medical equipment.
Virus Scans
Note: The HTM Service Line shall also verify that all non-removable mobile media (i.e., laptop computers and internal hard drives) are free of viral infections prior to use with VA medical equipment.
From VHA-V02-HTM-POL-00202 Acquisition of Medical Equipment: Fill in the Blank
If the medical devices require network connectivity, it is the responsibility of the BME or BESS to ensure all appropriate ____ ____ ____ ____ (XXXX) documentation is completed prior to the purchase of the device
Medical Device Protection Program (MDPP)
From VHA-V02-HTM-POL-00401 CM_Medical Equipment Unscheduled Service or Repair
Ensure that at least __% of work is documented to meet national KPI requirements
70%
From VHA-V02-HTM-SOP-00501 Ordering Parts and Services_Credit Card & 1358 Purchases
Use of Purchase Card for goods/services is allowed when:
1. It falls under the PC spending threshold ($#####)
2. The vendor accepts credit card orders
3. There are available funds in the (???)
4.The vendor is in the vendor file
$10,000
FCP - Fund Control Point
From VHA-V02-HTM-PL-00905 Performance Improvement_Hazard Recalls
Recall classifications by the FDA include:
Class I
Class II
Class III
List them in order of most dangerous to least dangerous.
Class I - most (can cause serious adverse health consequences)
Class II - (may cause temporary or reversible health consequences)
Class III - least (not likely to cause adverse health consequences)
From VHA-V02-HTM-SOP-00608 Networked Medical Systems_Server Management SOP
Define these acronyms:
ACL
ERA
MDUS
RDP
VLAN
ACL – Access Control List: limiting network access to only the ports and protocols that are needed for software to operate
ERA – Enterprise Risk Assessment: assess the risk a system poses to the VA network, and to identify mitigating factors to lower that risk
MDUS - Medical Device Update Server
RDP - – Remote Desktop Protocol: is the connection type to allow remote connections from one computer system to another.
VLAN - Virtual Local Area Network: used to keep network traffic segmented and isolated from other parts of the network
From VHA-V02-HTM-POL-00603 Networked Medical Device Risk Forms
If the procurement involves medical equipment that connects to the VA IT network or stores ePHI, what 2 forms need to be completed during pre-procurement?
1. VA Handbook 6500.6 Appendix A: Checklist for Information Security in the Initiation Phase of Acquisitions
2. VA Directive 6550 Appendix A: Pre-Procurement Assessment for Medical Device/Systems using National 6550 LEAF
From VHA-V02-BME-POL-00403 CM_Equipment Turn in
HTM assists in turning in excess medical equipment. They are responsible for the removal of ____ ____ from medical equipment. These will be provided to local OIT for destruction and disposal.
Hard Drives / removable media
From VHA-V02-HTM-POL-00902 Management and Maintenance of Alarm Systems
What term is described as: The desensitization and diminished response to clinical alarms by caregivers and staff due to the excessive quantity of alarms in their environment in combination with other environmental noise.
Alarm fatigue
Research indicates that alarm fatigue is a physical condition that occurs on the subconscious level, unknowingly to the caregiver. False and unnecessary alarms have been identified as one of the primary sources of alarm fatigue.
From VHA-V02-HTM-POL-00904 Performance Improvement PM Percent Complete
It is the policy of the VISN 2 HTM Service Line to routinely monitor the monthly PM completion status for all Medical Equipment in the Preventive Maintenance (PM) Program. TJC PM completion requirements are __% for High Risk and __% for Non-High-Risk PMs.
100% and 100%
From VHA-V02-HTM-SOP-00608 Networked Medical Systems Server Management SOP
The BESS responsibilities include:
Providing oversite and management of this standard operating procedure and perform annual reviews of the document to maintain current established best practices.
Manage the VISN vSphere instance and provide assistance to the facilities as needed.
Monitor and manage the VISN HTM Leaf portal for all server requests that are submitted
What is the vSphere?
vSphere: – VMWare’s client interface software for the management of virtual machines and their hosts.
From VHA-V02-HTM-POL-00203 New Medical Equipment Incoming Inspection Procedure
One of the things medical equipment/devices are to be inspected for during an incoming are leakage current limits and ground cord resistance (when required by NFPA 99).
In order to pass, chassis leakage current cannot exceed #µA and ground resistance cannot exceed #Ω.
Chassis leakage current cannot exceed 500µA and ground resistance cannot exceed 0.5Ω.
From VHA-V02-HTM-POL-00401 CM_Medical Equipment Unscheduled Service or Repair
It is the policy of the Healthcare Technology Management (HTM) Service Line per the Medical Equipment Management Plan (MEMP), that all Corrective Maintenance (CM) performed on medical equipment is documented via electronic Work Orders within ___ day(s) of job completion.
One Day
From VHA-V02-HTM-POL-00906 Medical Device Incident Reporting and Tracking
The VISN 2 HTM Service Line seeks to comply with the Safe Medical Device Act of 1990, as enacted by the (FDA), which provides a mechanism for the manufacturers and user facilities to identify, monitor and evaluate significant events involving medical devices so that problems can be detected and corrected in a timely manner.
HTM's role in an actual incident or a 'near miss' includes: leading the medical device investigation, communicating to local Patient Safety Management, recommending whether a MedWatch report should be made, and completing the HTM __ __ __ __ (????) form.
HTM Medical Device Incident Investigation (MDII) form
From VHA-V02-HTM-SOP-00802 Technical Training
It is the policy of the VISN 2 Healthcare Technology Management (HTM), Service Line to provide all local facility HTM Service Line staff with technical training and continued education to ensure they have the expertise required to develop and support HTM core functions at the local facility.
HTM/BMEs have core functions under the following subheadings
Planning and Evaluation (4)
Implementation & Project Management (5)
Technology Sustainment (5)
List one function that falls under each of these subheadings
Planning and Evaluation (Equipment Planning, Specification Development, Technical Evaluation, Risk Assessment)
Implementation & Project Management (Installation+Inspection, Site Readiness, System Design + Integration, Configuration Management, Operator Training)
Technology Sustainment (Maintenance Management, Safety alerts&recall management, Cybersecurity risk management, hardware+software uppgrades, Regulatory Compliance)
From VHA-V02-BME-POL-00604 Networked Medical Systems VPN
Purpose is to establish a standard procedure for establishing local-level secure virtual private network (VPN) connections to medical devices and systems.
BME and BESS responsibilities include:
Work with the ____ ___ ____ to determine which type of remote access is needed and assist the vendor in validating the connection once complete.
Ensure that all equipment that has vendor remote access is annotated correctly in the ___ ___ ___ ___ (????)
Contracting Officer Representative
Networked Medical Device Database (NMDD)
VHA-V02-HTM-POL-00201 New Medical Equipment_Non-VA Owned
Requests for loaner or demo equipment should be authorized by the Supply Chain Service and coordinated through the VAMC Healthcare Technology Management in advance of equipment arrival.
If the equipment will be in the VAMC for over ## days, it must be added to the inventory so that HTM can add it to the PM program and ensure manufacturer maintenance is being met.
90 days
From VHA-V02-HTM-POL-00301 PM_Documentation
Each PM work order must be closed out with one correct PM Status Code. Fill out the following PM Staus Codes:
1. P
2. D0
3. D1
4. D2
5. D3
6. C
1. P - Passed
2. D0 - Deferred
3. D1 - Deferred, Could Not Locate
4. D2 - Deferred, In Use
5. D3 - Deferred, Out of Service
6. C - Corrective Action
From VHA-V02-HTM-POL-00709 t ISO 17025:2017
It is the policy of the VISN 2 Healthcare Technology Management (HTM) Service Line that all laboratories used to perform calibrations on ultrasound leakage testers (ULT) are accredited and perform calibrations according to standards provided by the International Organization for Standardization (ISO) 17025:2017.
The biomedical equipment support specialist will verify that the calibration laboratory will use ISO 17025:2017 and create a #### specifying the calibration standard ISO 17025:2017 was requested.
2237
From CHA-V02-HTM-POL-00904 Performance Improvement PM Percent Complete
The TJC due dates for PMs are explained in VACO HTM service bulletin: SB2017-002.
Triannual PMs are due within __ days +/- the scheduled month.
Annual PMs are due within __ days +/- the scheduled month.
Semi-annual PMs are due within __ days +/- the scheduled month.
Quarterly PMs are due within __ days +/- the scheduled month.
Triannual - 45 days +/- the scheduled month.
Annual - 30 days +/- the scheduled month.
Semiannual - 20 days +/- the scheduled month.
Quarterly - 10 days +/- the scheduled month.
From VHA-V02-HTM-POL-00601 Networked Device Naming Convention
Each facility shall follow the guidelines within this policy to ensure network medical devices follow a consistent and standardized naming convention.
What are the naming conventions for:
Workstations
Virtual Desktops
Servers
Devices
Workstations
Grouping Code (4 characters), Device code (2 characters), Local Identifier (Equipment asset number [WHC-MDXXXXX]
Virtual Desktops
Grouping Code (4 characters), Device code (2 characters), Local Identifier (“T” for thin client followed by the Equipment asset
[WHC-MDTXXXXXX]
Servers
Organization Code (2 or 3 characters), Location code (2 or 3 characters), Function Code (3 characters-approved codes only), Local Identifier (1-8 character)[VHACASSQLREMSL1]
Devices
Grouping Code (4 characters), Device code (2 characters), Local Identifier (Equipment asset number) [CAS-PTXXXXXX]