1. © Copyright, The Joint Commission 2015 T HE H EALTHCARE E NVIRONMENT John Maurer, SASHE, CHFM, CHSP Engineering Department The Joint Commission

2. Department of Engineering 2015 2 © Copyright, The Joint Commission L EARNING O BJECTIVES  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

3. Department of Engineering 2015 3 © Copyright, The Joint Commission 2015 M OST C HALLENGING S TANDARDS M OST C ITES EC & LS I SSUES

4. Department of Engineering 2015 4 © Copyright, The Joint Commission Standard 2015 First 6 Months Non Compliance 2014 Non Compliance EC.02.06.0159%56% IC.02.02.0154%52% EC.02.05.0153% LS.02.01.2050% RC.01.01.0148%49% LS.02.01.3046%43% LS.02.01.1045%46% LS.02.01.3543% EC.02.03.0539%48% EC.02.02.0138%36%

5. Department of Engineering 2015 5 © Copyright, The Joint Commission M OST C ITED S TANDARDS : 2012 – 2015 YTD Standard2015201420132012 EC.02.06.01: Built Environment#1 #8#7 EC.02.05.01: Utility Systems Risks#3#2#4#10 LS.02.01.20: Means of Egress#4 #1#2 LS.02.01.30: Protection#6#9#6 LS.02.01.10: General Bldg Req’s#7 #3 LS.02.01.35: Extinguishment#8 #9 EC.02.03.05: Fire Safety Systems#9#6#7#5 EC.02.02.01: HazMat & Waste#10 #11

6. Department of Engineering 2015 6 © Copyright, The Joint Commission #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 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”

7. Department of Engineering 2015 7 © Copyright, The Joint Commission 2015, First 6 months2014 EC.02.04.03, EP 2 EC.02.04.03, EP 3 EC.02.04.03, EP 4 EC.02.04.01, EP 2EC.02.04.03, EP 5 EC.02.04.01, EP 2 Most Cited Medical Equipment EPs

8. Department of Engineering 2015 8 © Copyright, The Joint Commission W HAT 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?

9. Department of Engineering 2015 9 © Copyright, The Joint Commission W HAT 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?

10. Department of Engineering 2015 10 © Copyright, The Joint Commission S OME 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?

11. © Copyright, The Joint Commission W HAT H APPENED IN 2014? T HE H EALTHCARE E NVIRONMENT S TANDARDS U PDATE

12. Department of Engineering 2015 12 © Copyright, The Joint Commission T IME D EFINED The Joint Commission EC chapter defines time as:  Daily, weekly, monthly are calendar references  Quarterly is once every three months +/- 10 days  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

13. Department of Engineering 2015 13 © Copyright, The Joint Commission Q UARTERLY :+/- 10 DAYS S EMIANNUAL : +/- 20 DAYS A NNUAL : +/- 30 DAYS Due Date Scheduled Month 20 30 JulySeptOctAugNov June Dec Jan F M A J JON Semiannual Annual + + Jan M AS D Frequencies required by Code may not be modified (e.g. EC.02.05.07 EP 4 & 7) 10 JanFebruary March Apr Quarterly

14. Department of Engineering 2015 14 © Copyright, The Joint Commission NPSG 06.01.01: A LARM M GMT  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

15. Department of Engineering 2015 15 © Copyright, The Joint Commission NPSG.06.01.01: A LARM M GMT  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

16. Department of Engineering 2015 16 © Copyright, The Joint Commission Q UESTIONS TO C ONSIDER  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!

17. Department of Engineering 2015 17 © Copyright, The Joint Commission W HAT ’ S IN A N AME ?  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

18. © Copyright, The Joint Commission E QUIPMENT M ANAGEMENT M EDICAL E QUIPMENT : EC.02.04.01, EC.02.04.03 U TILITY S YSTEMS : EC.02.05.01, EC.02.05.05 APPLIES ONLY TO HOSPITAL & CRITICAL ACCESS HOSPITAL PROGRAMS

19. Department of Engineering 2015 19 © Copyright, The Joint Commission S&C 14-07-H OSPITAL  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.

20. Department of Engineering 2015 20 © Copyright, The Joint Commission S&C 14-07-H OSPITAL  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

21. Department of Engineering 2015 21 © Copyright, The Joint Commission EC.02.04.01 Standard EC.02.04.01 The hospital manages medical equipment risks EC.02.04.01 EP 1 The hospital solicits input from individuals who operate and service equipment when it selects and acquires medical equipment.

22. Department of Engineering 2015 22 © Copyright, The Joint Commission EC.02.04.01 EP 2 E FFECTIVE J ULY 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.

23. Department of Engineering 2015 23 © Copyright, The Joint Commission M AINTAINING M EDICAL E QUIPMENT  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

24. Department of Engineering 2015 24 © Copyright, The Joint Commission EC.02.04.01 EP 2 CONTINUED For hospitals that use Joint Commission accreditation for deemed status purposes: The hospital maintains a written inventory of all medical equipment. 4 th most cited medical equipment management EP in the first 6 months of 2015

25. Department of Engineering 2015 25 © Copyright, The Joint Commission I NVENTORY D EFINITIONS  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

26. Department of Engineering 2015 26 © Copyright, The Joint Commission EC.02.04.01 EP 3 E FFECTIVE J ULY 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

27. Department of Engineering 2015 27 © Copyright, The Joint Commission H IGH - RISK M EDICAL E QUIPMENT  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

28. Department of Engineering 2015 28 © Copyright, The Joint Commission J OINT C OMMISSION M EDICAL E QUIPMENT  Medical equipment includes equipment used in for monitoring, such as  Bedside monitors  Telemetry monitors

29. Department of Engineering 2015 29 © Copyright, The Joint Commission J OINT C OMMISSION M EDICAL E QUIPMENT  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) 3 rd edition

30. Department of Engineering 2015 30 © Copyright, The Joint Commission CMS I NVENTORY  Medical Equipment includes  Biomedical equipment  Radiological equipment  Patient beds, stretchers  IV infusion equipment  Ventilators  Laboratory equipment  Etc.

31. Department of Engineering 2015 31 © Copyright, The Joint Commission S COPES  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

32. Department of Engineering 2015 32 © Copyright, The Joint Commission 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

33. Department of Engineering 2015 33 © Copyright, The Joint Commission 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

34. Department of Engineering 2015 34 © Copyright, The Joint Commission 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

35. Department of Engineering 2015 35 © Copyright, The Joint Commission 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

36. Department of Engineering 2015 36 © Copyright, The Joint Commission EC.02.04.01 EP 6 CONTINUED  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)

37. Department of Engineering 2015 37 © Copyright, The Joint Commission 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.

38. Department of Engineering 2015 38 © Copyright, The Joint Commission EC.02.04.03 Standard EC.02.04.03 The hospital inspects, tests, and maintains medical equipment

39. Department of Engineering 2015 39 © Copyright, The Joint Commission M EDICAL E QUIPMENT T ESTING  EC.02.04.03 The hospital inspects, tests, and 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.

40. Department of Engineering 2015 40 © Copyright, The Joint Commission M EDICAL E QUIPMENT T ESTING  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.

41. Department of Engineering 2015 41 © Copyright, The Joint Commission M EDICAL E QUIPMENT T ESTING  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. Note: High-risk medical equipment includes life support equipment *Most cited medical equipment management EP in the first 6 months of 2015

42. Department of Engineering 2015 42 © Copyright, The Joint Commission M EDICAL E QUIPMENT T ESTING 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. *2 nd and 3 rd most cited medical equipment management EPs in the first 6 months of 2015

43. Department of Engineering 2015 43 © Copyright, The Joint Commission M EDICAL E QUIPMENT T ESTING EP 5: The hospital performs equipment maintenance and chemical and biological testing of water used in hemodialysis. These activities are documented. *5 th most cited medical equipment management EP in the first 6 months of 2015 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.

44. Department of Engineering 2015 44 © Copyright, The Joint Commission E QUIPMENT S URVEY P ROCESS 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

45. Department of Engineering 2015 45 © Copyright, The Joint Commission S URVEY P ROCESS : S TAFF I NTERVIEWS  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

46. Department of Engineering 2015 46 © Copyright, The Joint Commission S URVEY P ROCESS : S TAFF I NTERVIEWS  Equipment Maintainers  Evaluate their understanding 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

47. Department of Engineering 2015 47 © Copyright, The Joint Commission S URVEY P ROCESS : S TAFF I NTERVIEW  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

48. Department of Engineering 2015 48 © Copyright, The Joint Commission E VALUATING P ROGRAM E FFECTIVENESS  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?

49. Department of Engineering 2015 49 © Copyright, The Joint Commission E VALUATING P ROGRAM E FFECTIVENESS  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?

50. Department of Engineering 2015 50 © Copyright, The Joint Commission E VALUATING P ROGRAM E FFECTIVENESS : M ISCELLANEOUS T OPICS  Survey should focus on High-risk equipment  Are 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?

51. Department of Engineering 2015 51 © Copyright, The Joint Commission E QUIPMENT N OT F OUND OR I N U SE  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

52. Department of Engineering 2015 52 © Copyright, The Joint Commission E QUIPMENT N OT F OUND OR I N U SE  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

53. Department of Engineering 2015 53 © Copyright, The Joint Commission R ELOCATABLE P OWER T APS (RPT S )  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.”

54. Department of Engineering 2015 54 © Copyright, The Joint Commission R ELOCATABLE P OWER T APS  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

55. Department of Engineering 2015 55 © Copyright, The Joint Commission 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 process  This includes identifying where they are located at the unit level

56. Department of Engineering 2015 56 © Copyright, The Joint Commission C ATEGORICAL W AIVER P ROCESS 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

57. Department of Engineering 2015 57 © Copyright, The Joint Commission D EFINITIONS F ROM 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.

58. Department of Engineering 2015 58 © Copyright, The Joint Commission R EQUIREMENTS  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.

59. Department of Engineering 2015 59 © Copyright, The Joint Commission R EQUIREMENTS  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.

60. Department of Engineering 2015 60 © Copyright, The Joint Commission R EQUIREMENTS  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.

61. Department of Engineering 2015 61 © Copyright, The Joint Commission R EVISED R EQUIREMENTS FOR DIAGNOSTIC IMAGING

62. Department of Engineering 2015 62 © Copyright, The Joint Commission D IAGNOSTIC I MAGING  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

63. Department of Engineering 2015 63 © Copyright, The Joint Commission D IAGNOSTIC I MAGING  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

64. Department of Engineering 2015 64 © Copyright, The Joint Commission D IAGNOSTIC I MAGING  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

65. Department of Engineering 2015 65 © Copyright, The Joint Commission  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 B ACKGROUND

66. Department of Engineering 2015 66 © Copyright, The Joint Commission  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… B ACKGROUND

67. Department of Engineering 2015 67 © Copyright, The Joint Commission  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 B ACKGROUND

68. Department of Engineering 2015 68 © Copyright, The Joint Commission  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. N OTES

69. Department of Engineering 2015 69 © Copyright, The Joint Commission  T hese 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. N OTES

70. Department of Engineering 2015 70 © Copyright, The Joint Commission EC.02.01.01 EP 14: M ANAGE MRI S AFETY R ISKS  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

71. Department of Engineering 2015 71 © Copyright, The Joint Commission EC.02.01.01 EP 14  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

72. Department of Engineering 2015 72 © Copyright, The Joint Commission  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) EC.02.01.01 EP 16: M ANAGE MRI S AFETY R ISKS

73. Department of Engineering 2015 73 © Copyright, The Joint Commission 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 stop Stops computers Quench Stops magnet

74. Department of Engineering 2015 74 © Copyright, The Joint Commission  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 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. EC.02.02.01 EP 17: H AZ M AT R ISKS

75. Department of Engineering 2015 75 © Copyright, The Joint Commission 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

76. Department of Engineering 2015 76 © Copyright, The Joint Commission 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 : I MAGING

77. Department of Engineering 2015 77 © Copyright, The Joint Commission  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

78. Department of Engineering 2015 78 © Copyright, The Joint Commission 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.

79. Department of Engineering 2015 79 © Copyright, The Joint Commission 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

80. Department of Engineering 2015 80 © Copyright, The Joint Commission 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)

81. Department of Engineering 2015 81 © Copyright, The Joint Commission 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.

82. Department of Engineering 2015 82 © Copyright, The Joint Commission 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

83. Department of Engineering 2015 83 © Copyright, The Joint Commission 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 corrected within 30 days of discovery (not in JC standard but in ACR).

84. Department of Engineering 2015 84 © Copyright, The Joint Commission 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.

85. Department of Engineering 2015 85 © Copyright, The Joint Commission 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

86. Department of Engineering 2015 86 © Copyright, The Joint Commission EC.02.04.03 EP S 19-22 S UMMARY  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

87. Department of Engineering 2015 87 © Copyright, The Joint Commission EC.02.04.03 EP S 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.

88. Department of Engineering 2015 88 © Copyright, The Joint Commission 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.

89. Department of Engineering 2015 89 © Copyright, The Joint Commission 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.

90. Department of Engineering 2015 90 © Copyright, The Joint Commission 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).

91. Department of Engineering 2015 91 © Copyright, The Joint Commission EC.02.06.05 EP 4  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 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.

92. Department of Engineering 2015 92 © Copyright, The Joint Commission 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).

93. Department of Engineering 2015 93 © Copyright, The Joint Commission 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

94. Department of Engineering 2015 94 © Copyright, The Joint Commission D EPARTMENT OF E NGINEERING 630 792 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

95. Department of Engineering 2015 95 © Copyright, The Joint Commission  These slides are current as of 10/20/2015. 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. T HE J OINT C OMMISSION D ISCLAIMER