Transcript MD Expo

© Copyright, The Joint Commission
Department of Engineering 2015 1
2015
John Maurer, SASHE, CHFM, CHSP
Engineering Department
The Joint Commission
© Copyright, The Joint Commission
THE HEALTHCARE ENVIRONMENT
LEARNING OBJECTIVES
participant will be able to:
1. Understand the top challenging standards
relative to the physical environment
2. Understand risk and process improvement
relative to the physical environment
3. Understand recent and upcoming standards
changes
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 At the conclusion of this presentation, the
2014 CHALLENGING
STANDARDS
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THE TOP 20 ISSUES
2014 Non Compliance 2013 Non Compliance
EC.02.06.01
56%
39%
EC.02.05.01
53%
47%
IC.02.02.01
52%
46%
LS.02.01.20
50%
52%
RC.01.01.01
49%
52%
EC.02.03.05
48%
45%
LS.02.01.10
46%
48%
LS.02.01.35
43%
36%
LS.02.01.30
43%
45%
EC.02.02.01
36%
34%
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Standard
2014 Non Compliance 2013 Non Compliance
MM.03.01.01
35%
35%
PC.01.03.01
33%
27%
PC.02.01.03
29%
18%
EC.02.05.09
27%
21%
PC.03.01.03
26%
20%
MM.04.01.01
25%
22%
LD.01.03.01
23%
19%
LD.04.01.05
22%
14%
EC.02.05.07
21%
23%
IC.02.01.01
20%
13%
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Standard
TOP 10 CITED STANDARDS: 2011 – 2014
2014 2013 2012 2011
EC.02.06.01: Built Environment
#1
#8
#7
#11
EC.02.05.01: Utility Systems Risks
#2
#4
#10
#13
LS.02.01.20: Means of Egress
#4
#1
#2
#2
EC.02.03.05: Fire Safety Systems
#6
#7
#5
#5
LS.02.01.10: General Bldg Req’s
#7
#3
#3
#3
LS.02.01.35: Extinguishment
#8
#9
#9
#10
LS.02.01.30: Protection
#9
#6
#6
#4
#10
#11
#11
#15
EC.02.02.01: HazMat & Waste
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Standard
#18 LD.4.01.05
 Up 8% from 2013
 The hospital effectively manages its
programs, services, sites, or departments
 Problematic EP:
 EP 4: Staff are held accountable for their
Used when leadership has allowed non compliance
to exist without correction
 Sometimes used when situation is serious but does
not warrant a “decision rule”

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responsibilities
WHAT IS YOUR APPROACH TO ESC?




responsible?
Do you do what you need to do to “make it go away” or
are the issues analyzed to determine why the non
compliance is present?
Do you use this standard ESC response: “We have reeducated the “Fill In The Blank”?”
Have you looked at patient safety events and near
misses/close calls in relation to non compliance identified
during your survey?
Have you considered what the short term and long term
impact will be if you are unsuccessful in correcting the
RFIs?
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 Do you have a team approach or is one person
WHAT IS YOUR APPROACH TO ESC?
root causes of the RFIs?
 Does the safety culture in your organization encourage staff
and medical staff to identify system and process problems so
they can be addressed quickly or do you wait until something
happens or a surveyor finds it?
 When you develop your ESC do you find a way to incorporate
it into daily activities and processes or do you lay it on top of
everything else staff have to do?
 Is the culture in your organization one that allows the
importance of the ESC to fade after a few months or is patient
safety and compliance embedded in your mission/vision?
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 Do you develop generic ESC or are your ESC specific to the
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Bottom Line!
If you don’t address the
issues the first time you will
be continually be doing
rework and patient safety and
quality suffer!
SOME THINGS TO CONSIDER…
 Do you have the right people at the table to address
the issues identified?
 Are you focusing on systems and processes and how
to improve them?
 Have you had an issue with this requirement on
previous surveys?
determine whether or not the ESC has been effective
over the long term?
 If you find that your ESC hasn’t worked how do you go
about fixing that?
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 What kind of follow up monitoring have you planned to
2014
THE HEALTHCARE ENVIRONMENT
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STANDARDS UPDATE
Risk
RISK ICON
•
•
•
•
Proximity to patient
Probability of harm
Severity of harm
Number of patients at risk
 Integrated into the Manuals, E-dition, AMP, & FSA Tool
for three risk-focused categories:
1. National Patient Safety Goals
2. Accreditation program-specific risk area standards
3. Selected direct/indirect impact standards
 In addition, the FSA Tool will use the R icon to identify
the fourth risk category:
4. RFI standards from current cycle survey events.
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 All products will display a single icon at the EP level
The Joint Commission EC chapter defines time as:
 Daily, weekly, monthly are calendar references
 Quarterly is once every three months +/- 10 days
effective January 1, 2014
 Semi-annual is 6 months from the last scheduled event
month +/- 20 days
 Annual is 12 months from the last scheduled event
month +/- 30 days
 3 years is 36 months from the last scheduled event
month +/- 45 days
NOTE 1: The above does not apply to required frequencies
NOTE 2: An alternative of developing either a unique, written policy or adopting
NFPA definitions when available is acceptable
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TIME RE-DEFINED
QUARTERLY: +/- 10 DAYS
SEMIANNUAL: +/- 20 DAYS
ANNUAL: +/- 30 DAYS
10
20
Scheduled
Month
Due
Date
+
10
10
20
20
30
30
Quarterly
Jan
Semiannual
June
Annual
Jan
Aug
Sept
March
Apr
Oct
Dec
Nov
F M A M J J A S O N
10
20
30
30
February
July
Scheduled
Month
+
D
Jan
Frequencies required by Code may not be modified
(e.g. EC.02.05.07 EP 4 & 7)
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Due
Date
NPSG 06.01.01: ALARM MGMT
 In Phase I (beginning January 2014)
Hospitals will be required to:
manage based on their own internal situations.
 Input from medical staff and clinical depts
 Risk to patients due to lack of response,
malfunction
 Are specific alarms needed or contributing to
noise/fatigue
 Potential for patient harm based on internal
incident history
 Published best practices/guidelines
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 (by 7/14) establish alarms as an organization priority
 (during 2014) identify the most important alarms to
NPSG.06.01.01: ALARM MGMT
 In Phase II (as of January 2016)
Hospitals will be expected to:
policies and procedures that address at minimum:
 Clinically appropriate settings
 When they can be disabled
 When parameters can be changed
 Who can set and who can change parameters and
who can set to “off”
 Monitoring and response expectations
 Checking individual alarm signals for accurate
settings, proper operation and detectability
 educate those in the organization about alarm system
management for which they are responsible
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 develop and implement specific components of
QUESTIONS TO CONSIDER
a priority?
 Who is on the team addressing the NPSG?
 How far along are you in identifying the
most important alarm signals to manage?
 What is your biggest challenge?
 Remember that the entire goal must be
fully implemented by January of 2016!
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 Have you identified clinical alarm safety as
WHAT’S IN A NAME?
name, which indicates that technology that impacts patient care is
managed.
 CE: Clinical Engineer. 4 year Engineering degree with emphasis in
Clinical Engineering.
 BME: BioMedical Engineer: 4 year degree, typically working in
Research and Manufacturing for Healthcare
 BMET: BioMedical Equipment Technologist. Typically has a 2 or 4
year degree (or military equivalent), working directly in a
healthcare setting.
 CBET: Certified Biomedical Equipment Technician. A formal
certification by the International Certification Commission (ICC)
for the BMET who achieve this certification
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 HTM: Healthcare Technology Management is the department
EQUIPMENT MANAGEMENT
APPLIES ONLY TO
HOSPITAL & CRITICAL ACCESS HOSPITAL
PROGRAMS
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MEDICAL EQUIPMENT: EC.02.04.01, EC.02.04.03
UTILITY SYSTEMS: EC.02.05.01, EC.02.05.05
S&C 14-07-HOSPITAL
 S&C 12-07-Hospital Superceded
A hospital may adjust its maintenance, inspection, and
testing frequency and activities for facility and medical
equipment from what is recommended by the
manufacturer, based on a risk-based assessment by
qualified personnel, unless:
 Other Federal or state law; or hospital Conditions of
Participation (CoPs) require adherence to manufacturers’
recommendations and/or set specific requirements.
•
For example, all imaging/radiologic equipment must be
maintained per manufacturers’ recommendations; or
The equipment is a medical laser device; or
 New equipment without a sufficient amount of
maintenance history has been acquired.

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
S&C 14-07-HOSPITAL
 The organization inspects, tests & maintains New



Provided by the organization’s contractors
Available publically from nationally recognized
sources
Through the organization’s experience over time
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medical equipment or operating components of
utility systems in accordance with manufacturers’
recommendations with insufficient maintenance
history to support the use of alternative maintenance
strategies.
 Maintenance history may be gathered from
documented evidence such as
EC.02.04.01
Standard EC.02.04.01
The hospital manages medical equipment risks
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EC.02.04.01 EP 1
The hospital solicits input from individuals who operate
and service equipment when it selects and acquires
medical equipment.
For hospitals that do not use Joint Commission
accreditation for deemed status purposes: The
hospital maintains either a written inventory of all
medical equipment or a written inventory of
selected equipment categorized by physical risk
associated with use (including all life-support
equipment) and equipment incident history.
The hospital evaluates new types of equipment
before initial use to determine whether they should
be included in the inventory.
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EC.02.04.01 EP 2
EFFECTIVE JULY 2, 2014
MAINTAINING MEDICAL EQUIPMENT
 Inventory is populated based on one of two strategies:
 All equipment inclusion
 Physical risk based process
For example, evaluating:
• Function
• Risk Levels
• Maintenance Requirement
 Utilize resources, i.e. the FDA MAUDE report
 All life support equipment is included
 All new types of equipment evaluated for inclusion
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
EC.02.04.01 EP 2
CONTINUED
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For hospitals that use Joint Commission
accreditation for deemed status purposes:
The hospital maintains a written inventory of
all medical equipment.
INVENTORY DEFINITIONS
diagnosis, treatment, monitoring, and direct care of individuals.
 Life-support equipment—Any device used for the purpose of
sustaining life and whose failure to perform its primary function,
when used according to the manufacturer’s instructions and clinical
protocol, will lead to patient death in the absence of immediate
intervention (for example, ventilators, anesthesia machines, heartlung bypass machines, defibrillators).
 High-risk equipment—Any device or components of building utility
systems for which there is a risk of serious injury or death to a patient
or staff member if the device or component fails. High-risk equipment
includes life support equipment.
Source: Glossary from the Comprehensive Accreditation Manual for Hospitals,
The Joint Commission.
See also September 2014 Perspectives
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 Medical equipment—Fixed and portable equipment used for the
EC.02.04.01 EP 3
EFFECTIVE JULY 2, 2014
Note: High-risk medical equipment includes life-support
equipment
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The hospital identifies high-risk medical equipment
on the inventory for which there is a risk of serious
injury or death to a patient or staff member should
the equipment fail.
HIGH-RISK MEDICAL EQUIPMENT
 High-risk equipment
 Includes Life Support
Heart/lung bypass machine
 Anesthesia equipment
 Circulatory Assist Equipment
• IABP
• LVAD
 Ventilations
• Adult; Infant; MRI-Compatible
 Other High-risk equipment
 Defibrillators
 Robotic surgery devices
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
JOINT COMMISSION
MEDICAL EQUIPMENT
 Medical equipment includes equipment
used in for monitoring, such as
 Bedside monitors
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 Telemetry monitors
JOINT COMMISSION
MEDICAL EQUIPMENT

Electro-surgery

Lasers

Diathermy
 Diagnostic, such as

Laboratory analyzers

Radiology equipment

Endoscopes
Taken from the
Environment of
Care Handbook
Chapter 5 (page 73) 3rd
edition
 Patient support, such as

Patient beds

Specialty beds

Lifts
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 Treatment, such as
CMS INVENTORY
 Biomedical equipment
 Radiological equipment
 Patient beds, stretchers
 IV infusion equipment
 Ventilators
 Laboratory equipment
 Etc.
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 Medical Equipment includes
SCOPES
 Number 6 on ECRI Top 10 for 2014, #8 in 2013
result in follow-up survey under COP §482.42
 IC.02.02.02 EP 1 &2 hi/lo level disinfection
 IC.01.03.01 EP 1 – 5 risk assess & surveillance
 IC.01.05.01 EP 1 for policy issues
 Score at EC.02.05.01 EP 15 for ventilation issues,
will result in follow-up survey under COP §482.42
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 Score at IC. For infection control issues, and will
EC.02.04.01 EP 4
Note: The strategies of an AEM program must not reduce the safety of
equipment and must be based on accepted standards of practice.
An example of standards for a medical equipment program is ANSI/AAMI
EQ56:2013, Recommended Practice for a Medical Equipment Management
Program
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The hospital identifies the activities and associated
frequencies, in writing, for maintenance, inspecting, and
testing all medical equipment on the inventory. These
activities and associated frequencies are in accordance with
manufacturers’ recommendations or with strategies of an
alternative equipment maintenance (AEM) program.
EC.02.04.01 EP 5

Equipment subject to federal or state law or Medicare
Conditions of Participation in which inspecting, testing,
and maintaining be in accordance with manufacturers’
recommendations, or otherwise establishes more
stringent maintenance requirements
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For hospitals that use Joint Commission for deemed
status purposes: The hospital’s activities and
frequencies for inspecting, testing, and maintaining
the following items must be in accordance with
manufacturers’ recommendations
EC.02.04.01 EP 5
CONTINUED
Medical laser devices
 Imaging and radiologic equipment (whether used for
diagnostic or therapeutic purposes)
 New medical equipment with insufficient maintenance
history to support the use of alternative maintenance
strategies
Note: Maintenance history includes any of the following documented
evidence:
 Records provided by the hospital’s contractors
 Information made public by nationally recognized sources
 Records of the hospital’s experience over time
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
EC.02.04.01 EP 6
For hospitals that use Joint Commission for deemed
status purposes: A qualified individual(s) uses written
criteria to support the determination whether it is
safe to permit medical equipment to be maintained in
an alternative manner that includes the following:
and prevalence of harm during normal use
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 How the equipment is used, including the seriousness
EC.02.04.01 EP 6
CONTINUED
 Likely consequences of failure or malfunction,
(For more information on defining staff qualifications,
refer to Standard HR.01.02.01)
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including seriousness of and prevalence of harm
 Availability of alternative or back-up equipment in the
event the equipment fails or malfunctions
 Incident history of identical or similar equipment
 Maintenance requirements of the equipment
EC.02.04.01 EP 7
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For hospitals that use Joint Commission for
deemed status purposes: The hospital
identifies medical equipment on its inventory
that is included in an alternative equipment
maintenance program.
EC.02.04.03
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Standard EC.02.04.03
The hospital inspects, tests, and maintains medical
equipment
MEDICAL EQUIPMENT TESTING
 EC.02.04.03 The hospital inspects, tests, and
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maintains medical equipment
 EP 1: For hospitals that do not use Joint
Commission accreditation for deemed status
purposes: Before initial use of medical
equipment on the inventory the organization
performs safety, operational, and functional
checks.
MEDICAL EQUIPMENT TESTING
For hospitals that use Joint
Commission accreditation for deemed status
purposes: Before initial use and after major
repairs or upgrades of medical equipment on
the medical equipment inventory, the hospital
performs safety, operational, and functional
checks.
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 EP 1 (continued):
MEDICAL EQUIPMENT TESTING
 EC.02.04.03 The hospital inspects, tests, and
maintains medical equipment
 EP 2. The hospital inspects, tests, and
maintains all life support high-risk equipment.
These activities are documented.
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Note: High-risk medical equipment includes life support
equipment
MEDICAL EQUIPMENT TESTING
EP 4: The hospital conducts performance testing
of and maintains all sterilizers. These activities
are documented.
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EP 3: The hospital inspects, tests, and maintains
non-life support non-high-risk equipment
identified on the medical equipment inventory.
These activities are documented.
MEDICAL EQUIPMENT TESTING
EP 14: For hospitals that use Joint Commission
accreditation for deemed status purposes:
Qualified hospital staff inspect, test, and
calibrate nuclear medicine equipment annually.
The dates of these activities are documented.
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EP 5: The hospital performs equipment
maintenance and chemical and biological testing
of water used in hemodialysis. These activities
are documented.
MEDICAL EQUIPMENT TESTING
EP 17: For hospitals in California that provide
computed tomography (CT) services: A qualified
medical physicist measures actual radiation dose
produced by each CT imaging system at least
annually.
abdomen, and pediatric brain protocols is within
20 percent of actual dose delivered.
 Dates of the verifications are documented
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 Verifies dose displayed for adult brain, adult
Documentation is completed for High-risk, life support
and non-high-risk devices on the inventory
 Accuracy of Inventory
 All High-risk and Life Support equipment must be on
the inventory and identified
 Preventive maintenance frequencies must be clearly
defined in writing
 Confirm work done as per scheduled activities
 Ensure appropriate work is scheduled based on
maintenance strategies
 Evaluate equipment failure and scheduled actions
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EQUIPMENT SURVEY PROCESS
SURVEY PROCESS: STAFF INTERVIEWS
 Department Leader
 Evaluate the qualifications of the leader
Review appropriate documentation
 Evaluate how the inventory was created
 If an alternative maintenance program is in use,
evaluate the inclusion process
 Evaluate the Monitoring processes
 Evaluate the effectiveness of the program
 What criteria is used to evaluate
 Evaluate the Completion rate of maintenance
activities
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
SURVEY PROCESS: STAFF INTERVIEWS
 Equipment Maintainers
of the
maintenance process/strategies
 Evaluate staff knowledge related to the
alternative maintenance program
 Evaluate assignment of maintenance activities
 Evaluate competencies based on repeat work
orders
 Evaluate work scheduled against completed
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 Evaluate their understanding
SURVEY PROCESS: STAFF INTERVIEW
 Contract Services
 Evaluate the process used to ensure contractors use
qualified personnel
 Evaluate reliability of equipment serviced
 Evaluate integration of the process
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 Users of the Equipment
 Evaluate equipment reliability
 Evaluate response time when equipment fails
 Evaluate emergency response process
 Evaluate “Culture of Safety”
 Appropriate training of staff related to equipment use
 Customer satisfaction with department
EVALUATING PROGRAM EFFECTIVENESS
policies & procedures
 Evaluating the program:
 How is equipment evaluated to ensure no degradation
of performance?
 Consider miscalibration of equipment
 Consider test equipment calibration confirmation
 How are equipment-related incidents investigated?
 Could the malfunction have been avoided?
 Did the alternative maintenance strategy contribute
to the malfunction?
 How to sequester equipment deemed unsafe?
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 The equipment management programs must have written
EVALUATING PROGRAM EFFECTIVENESS
modifications to the maintenance strategy are
needed?
 Evaluate the accuracy of the inventory
 High-risk equipment segregated in the inventory?
 Equipment in an alternative maintenance program
segregated?
 Grouping of like equipment is acceptable
 Are imaging/radiologic equipment and medical
laser devices exempt from the alternative
maintenance program?
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 Is there a performance process to evaluate if
EVALUATING PROGRAM EFFECTIVENESS:
MISCELLANEOUS TOPICS
 Survey should focus on High-risk equipment
operation manuals and
maintenance schedules available?
 Verify the inspection, testing & maintaining
activities and frequencies are documented
 Evaluate the various maintenance strategies used
 Are they appropriate?
 Are they effective?
 Is the equipment reliable?
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 Are appropriate
EQUIPMENT NOT FOUND OR IN USE
 If a device is not available because it is not found or in use


Create policy describing how the device will be
looked for
• How will the users be involved
• How it impact the users
If the device was looked for “on time” then the PM
Completion rate will not be impacted
• The device must be reconciled
• Surveyors will be reviewing those “equipment not
found” or “in use” for reconciliation
−
Example: during the next month if 500 scheduled, 10 not
found the total activities should be 510
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 Manage the situation
EQUIPMENT NOT FOUND OR IN USE
 If the device was looked for “on time” then the PM
Completion rate will not be impacted
 The device must be reconciled
 Surveyors will be reviewing those “equipment
not found” or “in use” for reconciliation
• Example:
Each month 500 activities are scheduled
− One month 10 devices are “not available”
− Next month the 500 scheduled devices will be
done plus the missed 10 devices
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−
RELOCATABLE POWER TAPS (RPTS)
70, NFPA 99 and NFPA 101 all have regulations that control
the electrical components and equipment in a patient room.
It appears that it is the intent of these documents to restrict
RPT use so that it is not used in conjunction with medical
equipment
 CMS 3/2014:
 “RPT’s are not to be used with medical equipment in
patient care areas.
 This includes critical areas such as operating rooms,
recovery areas, intensive care areas, and non-critical
patient care areas such as patient rooms, diagnostic
areas, exam areas, etc.”
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 Healthcare Interpretation Task Force (12/2007) stated NFPA
RELOCATABLE POWER TAPS
equipment assembly. See NFPA 99-1999 7-5.1.2.5(2)
 Ceiling drops are acceptable. See NFPA 99-1999 7-5.1.2.5(3)
 RPTs may be used for non-patient care equipment such as
computers/monitors/printers, and in areas such as waiting rooms,
offices, nurse stations, support areas, corridors, etc.
 Precautions needed if RPT’s are used include:
 ensuring they are never “daisy-chained”
 preventing cords from becoming tripping hazards
 installing internal ground fault and over-current protection
devices
 using power strips that are adequate for the number and types
of devices used
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 RPTs may be used in anesthetizing locations if they are part of the
S&C: 14-46-LSC 9/26/2014
the use of power strips in existing and new health
care facility patient care areas, if you are in
compliance with all applicable 2012 LSC power strip
requirements and with all other 2000 LSC electrical
system and equipment provisions.
 The organization must follow all requirements of the
categorical waiver process
 This includes identifying where they are located
at the unit level
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 CMS is permitting a categorical waiver to allow for
If the organization decides to use this categorical waiver they
must
1. Ensure full compliance with the appropriate code
reference
2. Document the decision to adopt the categorical waiver
 The Relocatable Power Tap is not a LSC issue but an
Environment of Care issue
• For Environment of Care items document by Minutes
in discussion at the Environment of Care Committee
(or equivalent)
3. Declare the decision at the beginning of any survey
See also November 2013 Perspectives
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CATEGORICAL WAIVER PROCESS
DEFINITIONS FROM NFPA 99-2012
patient sleeping bed, or the bed or procedure table of a critical care
area.
 Patient-care-related electrical equipment is defined in section 3.3.137
as electrical equipment that is intended to be used for diagnostic,
therapeutic, or monitoring purposes in the patient care vicinity;
 Patient care room is defined in section 3.3.138 as any room of a health
care facility wherein patients are intended to be examined or treated.
Note that this term replaces the term “patient care area” used in the
1999 NFPA 99, but the definition has not changed.
 Patient care vicinity is defined in section 3.3.139 as a space, within a
location intended for the examination and treatment of patients (i.e.,
patient care room) extending 6 ft. beyond the normal location of the
bed, chair, table, treadmill, or other device that supports the patient
during examination and treatment and extends vertically 7 ft. 6 in.
above the floor.
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 Patient bed location is defined in section 3.3.136 as the location of a
REQUIREMENTS
 Power strips may be used in a patient care vicinity to power rack-, table-,





The receptacles are permanently attached to the equipment assembly.
The sum of the ampacity of all appliances connected to the receptacles
shall not exceed 75 percent of the ampacity of the flexible cord supplying
the receptacles.
The ampacity of the flexible cord is suitable in accordance with the
current edition of NFPA 70, National Electric Code.
The electrical and mechanical integrity of the assembly is regularly verified
and documented through an ongoing maintenance program.
Means are employed to ensure that additional devices or nonmedical
equipment cannot be connected to the multiple outlet extension cord
after leakage currents have been verified as safe.
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pedestal-or cart-mounted patient care-related electrical equipment
assemblies, provided all of the following conditions are met, as required
by section 10.2.3.6:
REQUIREMENTS
existing facilities that undergo renovation or a change in
occupancy, shall be provided with the minimum number of
receptacles as required by section 6.3.2.2.6.2.
 Power strips providing power to rack-, table-, pedestal-, or
cart-mounted patient care-related electrical equipment
assemblies are not required to be an integral component of
manufacturer tested equipment. Power strips may be
permanently attached to mounted equipment assemblies by
personnel who are qualified to ensure compliance with
section 10.2.3.6.
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 Patient bed locations in new health care facilities, or in
REQUIREMENTS
power non-patient care-related electrical equipment (e.g.,
personal electronics).
 Power strips may be used outside of the patient care vicinity
for both patient care-related electrical equipment & nonpatient-care-related electrical equipment.
 Power strips providing power to patient care-related
electrical equipment must be Special-Purpose Relocatable
Power Taps (SPRPT) listed as UL 1363A or UL 60601-1.
 Power strips providing power to non- patient-care-related
electrical equipment must be Relocatable Power Taps (RPT)
listed as UL 1363.
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 Power strips may not be used in a patient care vicinity to
REVISED REQUIREMENTS FOR
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DIAGNOSTIC IMAGING
DIAGNOSTIC IMAGING
 Three phases of implementation for hospitals, critical
access hospitals, and ambulatory care organizations
Includes ambulatory care organizations that have achieved
Advanced Diagnostic Imaging certification
 Phase 1

Exceptions: not applicable to dental cone beam CT radiographic
imaging studies performed for diagnosis of conditions affecting
the maxillofacial region or to obtain guidance for the treatment
of such conditions.
Phase 1.5: minimum qualifications for radiologists
performing CT scans
 Phase 2: fluoroscopy qualifications for non-radiologists
performing imaging exams and cone beam CT, and for dental
or oral surgical procedures

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
 Phase 1:
 Computed tomography (CT), nuclear medicine (NM),
positron emission tomography (PET), and magnetic
resonance imaging (MRI)
 Minimum competency for radiology technologists,
including registration and certification by July 1, 2015
 Annual performance evaluations of imaging equipment
by a medical physicist
 Documentation of CT radiation dose in the patient’s
clinical record
 Meeting the needs of the pediatric population through
imaging protocols and by considering patient size or
body habitus when establishing imaging protocols
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DIAGNOSTIC IMAGING
DIAGNOSTIC IMAGING
 Phase 1:
 Management of safety risks in the MRI environment
 Collection of data on incidents during which identified
radiation dose limits have been exceeded

Minimum quarterly review of staff dosimetry results
 New, replacement or modification to rooms

Medical physicist to perform structural shielding design
emitted or radioactive material is stored

Medical physicist to perform radiation protection
survey
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 New equipment or rooms where ionizing radiation is
BACKGROUND
 The new and revised imaging standards address
 Qualified staff
 Equipment that functions properly
 Processes to ensure safety and efficiency
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significant quality-and safety-related issues that
were not sufficiently addressed in Joint
Commission requirements
 They focus on processes that must be evaluated
to ensure the safe delivery of diagnostic imaging
services:
BACKGROUND
accredited ambulatory care organizations and hospitals
providing diagnostic imaging services, including those
that have achieved ADI certification
 Effective July 1, 2015
 Heavy focus on MRI and CT
 Research is underway to identify additional standards
and survey process changes for:
 cone beam CT
 fluoroscopy
 other risk areas…
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 They are accreditation requirements- applicable to all
BACKGROUND
 What is not included in these standards
changes?
qualifications for technologists performing
diagnostic CT exams
 Requirements that address minimum
qualifications for individuals interpreting
diagnostic CT exams
The work on these requirements will continue through
2015
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 Requirements that address minimum
NOTES
 These elements of performance does not apply
to dental cone beam CT radiographic imaging
studies performed for diagnosis of conditions
affecting the maxillofacial region or to obtain
guidance for the treatment of such conditions.
to CT systems used for therapeutic radiation
treatment planning or delivery, or for
calculating attenuation coefficients for nuclear
medicine studies.
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 These elements of performance does not apply
 These elements of performance are only applicable
for systems capable of calculating and displaying
radiation dose indices.
 While the CTDIvol, DLP, and SSDE are useful
indicators for monitoring radiation dose indices
from the CT machine, they do not represent the
patient’s radiation dose.
 Medical physicists are accountable for these
activities. They may be assisted with the testing
and evaluation of equipment performance by
individuals who have the required training and
skills, as determined by the physicist.
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NOTES
EC.02.01.01 EP 14: MANAGE MRI SAFETY RISKS
 Manage risks associated with the following

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Patients who may experience claustrophobia, anxiety, or
emotional distress
Patients who may require urgent or emergent medical care
Patients with medical implants, devices, or imbedded metallic
foreign objects (such as shrapnel)
Ferromagnetic objects entering the MRI environment
Acoustic noise
Useful Resource: MRIsafety.com
lists MRI safe medical devices and
implants
3T system generates 130 dBA
noise
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
EC.02.01.01 EP 14
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 Examples of compliance
 Patient history is obtained, available, and
reviewed
 Screening process addresses MRI safety risks
 Hearing protection is available and offered
 Staff can describe emergency procedures
EC.02.01.01 EP 16: MANAGE MRI SAFETY RISKS
 Manage risks by doing the following:


Restricting access of everyone not trained in MRI safety or
screened by staff trained in MRI safety from the scanner room
and the area that immediately precedes the entrance to the
MRI scanner room.
Making sure that these restricted areas are controlled by and
under the direct supervision of staff trained in MRI safety.
Posting signage at the entrance to the MRI scanner room that
conveys that potentially dangerous magnetic fields are present
in the room. Signage should also indicate that the magnet is
always on except in cases where the MRI system, by its design,
can have its magnetic field routinely turned on and off by the
operator.
Three types of magnets:
Permanent – low strength (Fonar), always on
Resistive – low strength (Fonar – 0.6T), may be turned off and on by operator, specialty,
limited studies
Superconducting –standard and high field strength; two STOPS (electrical-magnet still
on, Quench-magnet off)
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
EC.02.01.01, EP 16
Electrical stop
Stops computers
Quench
Stops magnet
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 Examples of compliance
 Everyone is either screened or trained on MRI safety
 Signage is appropriately posted and conveys MRI risks
 Designate the MRI as a security sensitive area with
controlled access
EC.02.02.01 EP 17: HAZMAT RISKS
 For hospitals that provide computed tomography (CT),
Who needs to be monitored?
State and federal limits (NRC-10% of Annual Limit; some states- 25% of annual
limit) Annual Prospective Limit Occupationally is 50 mSv (5000 mrem)
ALARA initially pertained to occupational exposure only – now generally
accepted to also apply to medical exposures as well as other sources of
radiation
ALARA limits established by the organization – generally 1.25 mSv (125 mrem)
per calendar quarter registered on the whole body or trunk monitor.
Staff dosimetry monitoring would imply personnel monitors not area
monitors.
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positron emission tomography (PET), or nuclear medicine
(NM) services: The results of staff dosimetry monitoring are
reviewed at least quarterly by the radiation safety officer,
diagnostic medical physicist, or health physicist to assess
whether staff radiation exposure levels are “As Low As
Reasonably Achievable” (ALARA) and below regulatory limits.
EC.02.02.01 EP 17
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 Examples of compliance
 Results of staff dosimetry monitoring are
reviewed by the RSO, diagnostic medical
physicist, or health physicist
EC.02.04.01 EP 10 & EC.02.04.03 EP 15: IMAGING
EP 10 The hospital identifies quality control and
maintenance activities to maintain the quality of the
diagnostic computed tomography (CT), positron
emission tomography (PET), magnetic resonance
imaging (MRI), and nuclear medicine (NM) images
produced. The organization identifies how often these
activities should be conducted.
EP 15 The hospital maintains the quality of the
diagnostic computed tomography (CT), positron
emission tomography (PET), magnetic resonance
imaging (MRI), and nuclear medicine (NM) images
produced.
 Implementation of the defined process
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 Process
EC.02.04.01 EP 10 & EC.02.04.03 EP 15
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 Examples of compliance
 Equipment testing and QC logs indicate that
equipment testing and QC are performed in
accordance with manufacturer’s guidelines and
organizational policy
EC.02.04.03 EP 17
 For diagnostic computed tomography (CT) services: At least


Measures the radiation dose (in the form of volume computed
tomography dose index [CTDIvol]) produced by each diagnostic CT
imaging system for the following four CT protocols: adult brain,
adult abdomen, pediatric brain, and pediatric abdomen. If one or
more of these protocols is not used by the hospital, other
commonly used CT protocols may be substituted.
Verifies that the radiation dose (in the form of CTDIvol) produced
and measured for each protocol tested is within 20 percent of the
CTDIvol displayed on the CT console. The dates, results, and
verifications of these measurements are documented.
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annually, a diagnostic medical physicist does the following:
EC.02.04.03 EP 17
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 Examples of compliance
 Annual equipment testing is documented by July
1, 2016
 Reports are dated and indicate that the testing
is performed at least annually by a diagnostic
medical physicist for identified protocols
EC.02.04.03 EP 19
services: At least annually, a diagnostic medical
physicist conducts a performance evaluation of all
CT imaging equipment. The evaluation results,
along with recommendations for correcting any
problems identified, are documented. The
evaluation includes the use of phantoms to assess
the following imaging metrics:
 Image uniformity
 Slice thickness accuracy
 Slice position accuracy (when prescribed from a scout
image)
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 For diagnostic computed tomography (CT)
EC.02.04.03 EP 19, CONTINUED
 Alignment light accuracy
 Table travel accuracy
 Radiation beam width
 High-contrast resolution
If ACR accredited all of these test
will have been completed annually.
Tests are most easily completed
using the ACR phantom but the
manufacturer’s or other phantoms
may be used for TJC purposes.
 Low-contrast resolution
 Geometric or distance accuracy
 Artifact evaluation
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 CT number accuracy and uniformity
EC.02.04.03 EP 20
magnetic resonance imaging (MRI) scientist
conducts a performance evaluation of all MRI
imaging equipment. The evaluation results, along
with recommendations for correcting any
problems identified, are documented. The
evaluation includes the use of phantoms to assess
the following imaging metrics:
 Image uniformity for all radiofrequency (RF) coils used
clinically
 Signal-to-noise ratio (SNR) for all coils used clinically
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 At least annually, a diagnostic medical physicist or
EC.02.04.03 EP 20, CONTINUED
 Slice thickness accuracy
 Slice position accuracy
 Alignment light accuracy
 High-contrast resolution
 Low-contrast resolution (or contrast-to-noise ratio)
 Geometric or distance accuracy
 Artifact evaluation
Uniformity test valid only for volume coils. Surface coils can be checked
by visual inspection of the field and calculating the SNR.
If ACR accredited all of these tests are being performed annually.
If the unit fails any test, the cause should be determined and corrected
within 30 days of discovery (not in JC standard but in ACR).
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 Magnetic field homogeneity
EC.02.04.03 EP 21
 At least annually, a diagnostic medical physicist or nuclear






Image uniformity/system uniformity
High-contrast resolution/system spatial resolution
If ACR accredited all of these test will have
Sensitivity
been completed annually. Various phantoms
Energy resolution
and methods can be used to evaluate these
Count-rate performance parameters.
Artifact evaluation
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medicine physicist conducts a performance evaluation of
all nuclear medicine imaging equipment. The evaluation
results, along with recommendations for correcting any
problems identified, are documented. The evaluations are
conducted for all of the image types produced clinically by
each NM scanner (for example, planar and/or tomographic)
and include the use of phantoms to assess the following
imaging metrics:
EC.02.04.03 EP 22
 At least annually, a diagnostic medical physicist conducts a




Image uniformity/system uniformity
High-contrast resolution/system spatial resolution
Low-contrast resolution or detectability (not applicable for planar
acquisitions)
Artifact evaluation
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performance evaluation of all positron emission
tomography (PET) imaging equipment. The evaluation
results, along with recommendations for correcting any
problems identified, are documented. The evaluations are
conducted for all of the image types produced clinically by
each PET scanner (for example, planar and/or
tomographic) and include the use of phantoms to assess
the following imaging metrics:
EC.02.04.03 EPS 19-22 SUMMARY
They may be assisted with the testing and evaluation of
equipment performance by individuals who have the
required training and skills, as determined by the
physicist.
 Medical physicists are not required to be present during all
data collection and testing
 Others may assist with data collection and testing, but it
must be reviewed by the medical physicist
 Examples of those who may assist include: biomed staff,
imaging technologists, or vendor/manufacturer service
personnel
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 Medical physicists are accountable for these activities.
 Examples of compliance
 Performance evaluation reports indicate
testing was done at least annually by a
diagnostic medical physicist, MRI Scientist, or
Nuclear medical physicist, as applicable
 Specified tests are conducted, and evaluation
results, recommendations and follow-up are
documented
EP 22: A Nuclear Medicine Physicist may also conduct this testing. A PET scanner
is a type of nuclear medicine camera. The intent of this requirement is that a
qualified individual conduct this evaluation.
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EC.02.04.03 EPS 19-22
EC.02.04.03 EP 23
emission tomography (PET), nuclear medicine
(NM), or magnetic resonance imaging (MRI)
services: The annual performance evaluation
conducted by the diagnostic medical physicist or
MRI scientist (for MRI only) includes testing of
image acquisition display monitors for maximum
and minimum luminance, luminance uniformity,
resolution, and spatial accuracy.
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 For computed tomography (CT), positron
 Examples of compliance
 Performance evaluation reports indicate that
they were performed at least annually by a
diagnostic medical physicist, MRI Scientist, or
Nuclear Medical Physicist, as applicable
 Specified tests are conducted
 This EP does not apply to monitors used for
interpretation
This applies to the monitors used by the operator only. Requirements for those
monitors used for interpretation will be formulated at a later date.
This requirement involves the use of a test pattern (usually SMPTE) and an
appropriate luminance meter. Some monitors have a luminescence meter built-in.
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EC.02.04.03 EP 23
EC.02.06.05 EP 4
emission tomography (PET), or nuclear medicine
(NM) services: Prior to installation of new imaging
equipment, replacement of existing imaging
equipment, or modification to rooms where
ionizing radiation will be emitted or radioactive
materials will be stored (such as scan rooms or hot
labs), a medical physicist or health physicist
conducts a structural shielding design* assessment
to specify required radiation shielding.
* For additional guidance on shielding designs and radiation protection surveys, see National Council on
Radiation Protection and Measurements Report No. 147 (NCRP-147).
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 For computed tomography (CT), positron
EC.02.06.05 EP 4
NCRP makes recommendations only –although they are widely used. CT generally requires that shielding
material
(usually lead or concrete) be placed in the walls and sometimes in the ceiling or floor. PET, particularly a
PET-CT
unit will also generally require shielding material in the walls, possibly floor and ceiling. A traditional
nuclear medicine lab will shield the radioactive materials locally using leaded containers, no area shielding
is used.
Most states require that a shielding evaluation of x-ray units, including CT be performed by an individual
recognized or licensed by the state prior to approving construction plans.
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 Examples of compliance
 Evidence that structural shielding design
assessments were conducted by a physicist,
prior to new installations, equipment
replacements, or room modifications
 Not retroactive- applies as of July 1, 2015
EC.02.06.05 EP 6
emission tomography (PET), or nuclear medicine
(NM) services: After installation of imaging
equipment or construction in rooms where
ionizing radiation will be emitted or radioactive
materials will be stored, a medical physicist or
health physicist conducts a radiation protection
survey to verify the adequacy of installed
shielding.* This survey is conducted prior to
clinical use of the room.
* For additional guidance on shielding designs and radiation protection surveys, see National Council on
Radiation Protection and Measurements Report No. 147 (NCRP-147).
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 For computed tomography (CT), positron
EC.02.06.05 EP 6
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 Examples of compliance
 Evidence that structural shielding design
assessments were conducted by a physicist,
prior to new installations, equipment
replacements, or room modifications
 Not retroactive- applies as of 7/1/15
DEPARTMENT OF ENGINEERING
630 792 5900
Director
Andrea Browne, PhD, Medical Physicist
Engineer
Anne Guglielmo, CFPS, LEED, A.P., CHSP
Engineer
John Maurer, SASHE, CHFM, CHSP
Engineer
Kathy Tolomeo, CHEP
Engineer
James Woodson, P.E., CHFM
Engineer
Department of Engineering 2015 98
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George Mills, MBA, FASHE, CEM, CHFM, CHSP
THE JOINT COMMISSION DISCLAIMER
Commission reserves the right to change the content of the
information, as appropriate.
 These slides are only meant to be cue points, which were
expounded upon verbally by the original presenter and are not
meant to be comprehensive statements of standards
interpretation or represent all the content of the presentation.
Thus, care should be exercised in interpreting Joint
Commission requirements based solely on the content of these
slides.
 These slides are copyrighted and may not be further used,
shared or distributed without permission of the original
presenter or The Joint Commission.
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 These slides are current as of 3/20/2015. The Joint