department of engineering 2015 1 © copyright, the joint commission

Department of Engineering 2015 1

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2015

THE HEALTHCARE ENVIRONMENT

John Maurer, SASHE, CHFM, CHSP

Engineering Department

The Joint Commission


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LEARNING OBJECTIVES

At the conclusion of this presentation, the 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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2014 CHALLENGING STANDARDS

THE TOP 20 ISSUES


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Standard 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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TOP 10 CITED STANDARDS: 2011 – 2014

Standard 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

EC.02.02.01: HazMat & Waste #10 #11 #11 #15


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#18 LD.4.01.05

Up 8% from 2013 The hospital effectively manages its

programs, services, sites, or departmentsProblematic EP:EP 4: Staff are held accountable for their

responsibilities 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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WHAT IS YOUR APPROACH TO ESC?

Do you have a team approach or is one person 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 re-educated 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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WHAT IS YOUR APPROACH TO ESC?

Do you develop generic ESC or are your ESC specific to the 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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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!


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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?

What kind of follow up monitoring have you planned to 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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2014

THE HEALTHCARE ENVIRONMENT

STANDARDS UPDATE


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RISK ICON

Integrated into the Manuals, E-dition, AMP, & FSA Tool All products will display a single icon at the EP level

for three risk-focused categories:1. National Patient Safety Goals2. Accreditation program-specific risk area standards3. 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.

Risk• Proximity to patient• Probability of harm• Severity of harm• Number of patients at risk


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TIME RE-DEFINED

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 daysNOTE 1: The above does not apply to required frequenciesNOTE 2: An alternative of developing either a unique, written policy or adopting

NFPA definitions when available is acceptable


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QUARTERLY: +/- 10 DAYSSEMIANNUAL: +/- 20 DAYS

ANNUAL: +/- 30 DAYSDue Date

Due Date

Scheduled Month

Scheduled Month20 202020

30 303030

July Sept OctAug NovJune Dec

Jan F M A J J O N

Semiannual

Annual

+ +

JanM A S D

Frequencies required by Code may not be modified (e.g. EC.02.05.07 EP 4 & 7)

10 10 10 10

Jan February March AprQuarterly


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NPSG 06.01.01: ALARM MGMT

In Phase I (beginning January 2014) Hospitals will be required to:

(by 7/14) establish alarms as an organization priority (during 2014) identify the most important alarms 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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NPSG.06.01.01: ALARM MGMT In Phase II (as of January 2016) Hospitals will be expected to:

develop and implement specific components of 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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QUESTIONS TO CONSIDER Have you identified clinical alarm safety as

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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WHAT’S IN A NAME?

HTM: Healthcare Technology Management is the department 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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EQUIPMENT MANAGEMENT

MEDICAL EQUIPMENT: EC.02.04.01, EC.02.04.03

UTILITY SYSTEMS: EC.02.05.01, EC.02.05.05

APPLIES ONLY TO HOSPITAL & CRITICAL ACCESS HOSPITAL

PROGRAMS


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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

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 Provided by the organization’s contractors Available publically from nationally recognized

sources Through the organization’s experience over time


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EC.02.04.01

Standard EC.02.04.01The hospital manages medical equipment risks

EC.02.04.01 EP 1The hospital solicits input from individuals who operate

and service equipment when it selects and acquires medical equipment.


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EC.02.04.01 EP 2EFFECTIVE JULY 2, 2014

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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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 2CONTINUED

For hospitals that use Joint Commission accreditation for deemed status purposes: The hospital maintains a written inventory of all medical equipment.


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INVENTORY DEFINITIONS Medical equipment—Fixed and portable equipment used for the

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, heart-lung 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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EC.02.04.01 EP 3EFFECTIVE JULY 2, 2014

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.

Note: High-risk medical equipment includes life-support equipment


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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 asBedside monitors Telemetry monitors


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JOINT COMMISSION MEDICAL EQUIPMENT

Treatment, such as Electro-surgery Lasers Diathermy

Diagnostic, such as Laboratory analyzers Radiology equipment Endoscopes

Patient support, such as Patient beds Specialty beds Lifts

Taken from the Environment of

Care Handbook

Chapter 5 (page 73) 3rd edition


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CMS INVENTORY

Medical Equipment includesBiomedical equipmentRadiological equipmentPatient beds, stretchersIV infusion equipmentVentilators Laboratory equipmentEtc.


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SCOPES

Number 6 on ECRI Top 10 for 2014, #8 in 2013 Score at IC. For infection control issues, and will

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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EC.02.04.01 EP 4

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.

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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EC.02.04.01 EP 5

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

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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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:

How the equipment is used, including the seriousness and prevalence of harm during normal use


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Likely consequences of failure or malfunction, 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

(For more information on defining staff qualifications, refer to Standard HR.01.02.01)


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EC.02.04.01 EP 7

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.


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EC.02.04.03

Standard EC.02.04.03The hospital inspects, tests, and maintains medical

equipment


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MEDICAL EQUIPMENT TESTING

EC.02.04.03 The hospital inspects, tests, and maintains medical equipmentEP 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.


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EP 1 (continued): 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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EC.02.04.03 The hospital inspects, tests, and maintains medical equipmentEP 2. The hospital inspects, tests, and

maintains all life support high-risk equipment. These activities are documented.

Note: High-risk medical equipment includes life support equipment


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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.

EP 4: The hospital conducts performance testing of and maintains all sterilizers. 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.

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 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.

Verifies dose displayed for adult brain, adult abdomen, and pediatric brain protocols is within 20 percent of actual dose delivered.

Dates of the verifications are documented


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EQUIPMENT SURVEY PROCESS

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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SURVEY PROCESS: STAFF INTERVIEWS

Department LeaderEvaluate the qualifications of the leader

Review appropriate documentationEvaluate how the inventory was created If an alternative maintenance program is in use,

evaluate the inclusion process Evaluate the Monitoring processesEvaluate 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 MaintainersEvaluate their understanding of the

maintenance process/strategiesEvaluate staff knowledge related to the

alternative maintenance programEvaluate assignment of maintenance activities Evaluate competencies based on repeat work

ordersEvaluate work scheduled against completed


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SURVEY PROCESS: STAFF INTERVIEW

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

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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EVALUATING PROGRAM EFFECTIVENESS

The equipment management programs must have written 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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EVALUATING PROGRAM EFFECTIVENESS

Is there a performance process to evaluate if 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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EVALUATING PROGRAM EFFECTIVENESS: MISCELLANEOUS TOPICS

Survey should focus on High-risk equipmentAre appropriate 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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EQUIPMENT NOT FOUND OR IN USE If a device is not available because it is not found or in use

Manage the situation 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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EQUIPMENT NOT FOUND OR IN USE

If the device was looked for “on time” then the PM Completion rate will not be impactedThe 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)

Healthcare Interpretation Task Force (12/2007) stated NFPA 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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RELOCATABLE POWER TAPS RPTs may be used in anesthetizing locations if they are part of the

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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S&C: 14-46-LSC 9/26/2014

CMS is permitting a categorical waiver to allow for 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 processThis includes identifying where they are located at

the unit level


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CATEGORICAL WAIVER PROCESS

If the organization decides to use this categorical waiver they must1. Ensure full compliance with the appropriate code reference2. 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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DEFINITIONS FROM NFPA 99-2012

Patient bed location is defined in section 3.3.136 as the location of a 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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REQUIREMENTS

Power strips may be used in a patient care vicinity to power rack-, table-, 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: 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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REQUIREMENTS

Patient bed locations in new health care facilities, or in 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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REQUIREMENTS

Power strips may not be used in a patient care vicinity to 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 & non-patient-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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REVISED REQUIREMENTS FOR DIAGNOSTIC IMAGING


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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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DIAGNOSTIC IMAGING

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

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

New equipment or rooms where ionizing radiation is emitted or radioactive material is stored Medical physicist to perform radiation protection survey


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The new and revised imaging standards address 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: Qualified staff Equipment that functions properly Processes to ensure safety and efficiency

BACKGROUND


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They are accreditation requirements- applicable to all 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…

BACKGROUND


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What is not included in these standards changes? Requirements that address minimum

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

BACKGROUND


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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.

These elements of performance does not apply to CT systems used for therapeutic radiation treatment planning or delivery, or for calculating attenuation coefficients for nuclear medicine studies.

NOTES


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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.

NOTES


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EC.02.01.01 EP 14: MANAGE MRI SAFETY RISKS Manage risks associated with the following

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

Examples of compliancePatient history is obtained, available, and

reviewedScreening process addresses MRI safety risksHearing protection is available and offeredStaff can describe emergency procedures


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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 studiesSuperconducting –standard and high field strength; two STOPS (electrical-magnet still on, Quench-magnet off)

EC.02.01.01 EP 16: MANAGE MRI SAFETY RISKS


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EC.02.01.01, EP 16

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

Electrical stopStops computers Quench

Stops magnet


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For hospitals that provide computed tomography (CT), 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.

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 radiationALARA 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.

EC.02.02.01 EP 17: HAZMAT RISKS


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EC.02.02.01 EP 17

Examples of compliance Results of staff dosimetry monitoring are

reviewed by the RSO, diagnostic medical physicist, or health physicist


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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.

Process

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

EC.02.04.01 EP 10 & EC.02.04.03 EP 15:

IMAGING


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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.02.04.01 EP 10 & EC.02.04.03 EP 15


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EC.02.04.03 EP 17

For diagnostic computed tomography (CT) services: At least annually, a diagnostic medical physicist does the following: 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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EC.02.04.03 EP 17

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


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EC.02.04.03 EP 19

For diagnostic computed tomography (CT) 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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EC.02.04.03 EP 19, CONTINUED

Alignment light accuracy Table travel accuracy Radiation beam width High-contrast resolution Low-contrast resolution Geometric or distance accuracy CT number accuracy and uniformity Artifact evaluation

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.


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EC.02.04.03 EP 20

At least annually, a diagnostic medical physicist or 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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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 Magnetic field homogeneity 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 correctedwithin 30 days of discovery (not in JC standard but in ACR).


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EC.02.04.03 EP 21 At least annually, a diagnostic medical physicist or nuclear

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: Image uniformity/system uniformity High-contrast resolution/system spatial resolution Sensitivity Energy resolution Count-rate performance Artifact evaluation

If ACR accredited all of these test will have been completed annually. Various phantoms and methods can be used to evaluate these parameters.


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EC.02.04.03 EP 22

At least annually, a diagnostic medical physicist conducts a 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: 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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EC.02.04.03 EPS 19-22 SUMMARY

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.

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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EC.02.04.03 EPS 19-22

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 EP 23

For computed tomography (CT), positron 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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EC.02.04.03 EP 23

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.02.06.05 EP 4

For computed tomography (CT), positron 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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EC.02.06.05 EP 4

Examples of complianceEvidence 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, 2015NCRP 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-CTunit 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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EC.02.06.05 EP 6

For computed tomography (CT), positron 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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EC.02.06.05 EP 6

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


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DEPARTMENT OF ENGINEERING630 792 5900

George Mills, MBA, FASHE, CEM, CHFM, CHSP

Director

Anne Guglielmo, CFPS, LEED, A.P., CHSP

Engineer

John Maurer, SASHE, CHFM, CHSP

Engineer

James Woodson, P.E., CHFM

Engineer

Kathy Tolomeo, CHEP

Engineer Andrea Browne, PhD, Medical Physicist

Engineer


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These slides are current as of 3/20/2015. The Joint 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.

THE JOINT COMMISSION DISCLAIMER

department of engineering 2015 1 © copyright, the joint commission

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