1. How Does Your HTM Program Score? A, B, C, D or F? Patrick K. Lynch CHTM, CBET, CCE, CCE, CPHIMS Global Medical Imaging

2. Who am I? CHTM, CBET, CCE, CPHIMS, CHTS-PW, fACCE 40 years in Biomed Managed large In-house, ISO and corporate Biomeds Active in certification of BMETs and CEs 1 st Pres of NCBA (North Carolina branch) - 1980 President, HTMA-SC Treasurer – HTMA-GA Member of all Biomed Associations (honorary NC, KY, Utah) Board Member – META, SC, GA Advisor – OH, KY, TN, UT, VA, NC, Texas Writes monthly for TechNation and BI&T (AAMI) - Heineman Medical Foundation (Guatemala) Currently, works for GMI is sales development, who sponsors my activities 2

3. Measures of HTM Performance Traditional HTM o PM Completion o Budget Performance Internal Benchmarks External Benchmarks COSR 3

4. Starts with self-evaluation SunHealth QM Survey – 1979 ASHE Maintenance of Medical Equipment – 1988 Journal of Clinical Engineering – 1990 AAMI HTM Levels Guide - 2014 4

5. HTM Levels Guide Published 2014 Written by 3 extreme leaders of the field – o Matthew Baretich o Frank Painter o Ted Cohen The best comprehensive tool to evaluate an HTM program Free from AAMI I have copies for all of you (courtesy AAMI) It is a very compact document It needs to be exploded and repackaging to be of maximum usefullness. That is what my presentation is – a reformatting and simplification of the HTM Levels Guide. 5

6. HTM Levels Guide - Overview Assumes 3 levels of HTM Programs o Fundamental (Level 1) Essential services only o Progressive (Level 2) – Beyond essential and focusses on cost savings o Advanced (Level 3) – Leading edge, demonstrates full range of possible HTM contributions. 6

7. HTM Levels Guide - Overview 9 Key Characteristics 1.Program Scope 2.Regulatory Compliance 3.Program Management 4.Equipment Maintenance & Technology Management 5.Personnel Management & staff development 6.Tactical & Strategic Planning 7.Performance Monitoring & Performance Improvement 8.Patient & Staff Safety 9.Internal & External Relationships 7

8. HTM Levels - Overview FundamentalProgressiveAdvanced Program Scope131 Regulatory Compliance121 Program Management353 Equip Maintenance & Tech Mgmt 453 Personnel Mgmt & Staff Development 243 Tactical & Strategic Planning165 Performance Montoring & Improvement 141 Patient & Staff Safety242 Internal & External Relationships 233 8

9. As you hear about these measures and think about your own program... Nobody is perfect It is difficult to give ourselves a totally honest evaluation. There are lots of rationalizations for our lack of top performance. o it isn’t important o they won’t let us o our culture is different o blah, blah, blah Are these reasons or excuses? Are we just not making a compelling case? There is always room for improvement. 9

10. HTM Program maintains MOST of the general biomedical equipment in the organization. 1 of 1 10

11. The HTM program maintains ALMOST ALL general medical equipment. 1 of 3 11

12. The HTM program maintains or manages some advanced medical technology (e.g. imaging, laboratory). 2 of 3 12

13. The HTM program has "clinical engineering" capabilities available from a qualified clinical engineer. 3 of 3 13

14. The HTM program manages all HTM-relates costs for the organization. 1 of 1 14

15. The HTM program achieves compliance with accreditation standards and government regulations. 1 of 1 15

16. The HTM program has up-to-date knowledge of applicable codes, standards and regulations. 1 of 2 16

17. The HTM program implements cost-effective compliance strategies. 2 of 2 17

18. HTM program leadership works proactively with regulatory agencies and standards organizations to develop and update medical technology-related regulations, codes and standards. 1 of 1 18

19. The HTM program has a current, written medical equipment management plan (MEMP). 1 of 3 19

20. The HTM Program has an equipment control program in place with a risk-based inventory. 2 of 3 20

21. The HTM program uses a Computerized Maintenance Management Program (CMMS) for inventory, maintenance scheduling, and maintenance history. 3 of 3 21

22. The HTM program is a distinct organizational entity with a qualified, dedicated manager and a separate budget. 1 of 5 22

23. The HTM manager has access to financial information needed to carry out these responsibilities. 2 of 5 23

24. The HTM department calculates the Cost of Service Ratio (COSR). 3 of 5 24

25. The HTM program uses a CMMS with a productivity and cost analysis capabilities. 4 of 5 25

26. The HTM program has adequate space, tools and equipment. 5 of 5 26

27. The HTM program operates like a business. 1 of 3 27

28. The HTM program monitors productivity. 2 of 3 28

29. The HTM program's CMMS has extensive analytical and technology management features. 2 of 3 29

30. The HTM program has written procedures for safety and functional testing and preventive maintenance. 1 of 4 30

31. The HTM program has written schedules for inspecting and maintaining medical equipment. 2 of 4 31

32. 3 of 4 The HTM program has a process for regular calibration of test equipment. 32

33. 4 of 4 The HTM program has the ability to readily obtain repair parts. 33

34. Including all newly-acquired device types in the MEMP is based upon a written rick assessment process. 1 of 5 34

35. Maintenance procedures and schedules are based on recognized resources and organizational data. 2 of 5 35

36. The HTM program includes management of stock parts (e.g. in their CMMS or other materials management system). 3 of 5 36

37. The MEMP inventory accuracy is verified at documented intervals by a sample physical inventory. 4 of 5 37

38. Service contracts include provisions for periodic auditing of vendor qualifications. 5 of 5 38

39. The HTM program manages medical technologies throughout the entire equipment life cycle. 1 of 3 39

40. The HTM program uses evidence-based maintenance strategies. 2 of 3 40

41. The HTM program integrates RM (risk management) and QA (quality assurance) into HTM. 3 of 3 41

42. HTM program personnel have appropriate education, experience, credentials and values. 1 of 2 42

43. HTM program job descriptions and job titles conform to professional standards. 2 of 2 43

44. The HTM program has a process for orienting new staff members. 2 of 4 44

45. The HTM program has a budgeted continuing education education program. 3 of 4 45

46. The HTM program supports participation in regional or national professional associations. 4 of 4 46

47. The HTM program reports directly to the Vice president or C-suite level. 1 of 3 47

48. The HTM program has a qualified clinical engineer on staff. 2 of 3 48

49. At least 30% of the HTM program technical staff holds a professional certification. 3 of 3 49

50. The HTM program is regularly included in the process for selection and the acquisition of medical equipment. 1 of 1 50

51. The HTM program is involved in capital planning and replacement equipment planning. 1 of 6 51

52. The HTM program is involved in equipment planning for construction and renovation projects. 2of 6 52

53. The HTM program is involved in all purchases of new equipment. 3 of 6 53

54. The HTM program records data for technology planning in the CMMS. 4 of 6 54

55. The HTM program works with clinical staff to understand their needs and identify appropriate technologies. 5 of 6 55

56. The HTM program ensures that user and service training is included with most new equipment purchases. 6 of 6 56

57. The HTM program has a leadership role in important clinical technology decisions. 1 of 5 57

58. The HTM program actively participated in strategic (long-term) technology planning and assessment. 2 of 5 58

59. The HTM program provides guidance on healthcare technology integration in all construction and renovation. 3 of 5 59

60. The HTM program collaborates on the selection of all medical device-related technologies. 4 of 5 60

61. The HTM program takes leadership and active participant roles in CE-IT convergence issues. 5 of 5 61

62. The HTM Program regularly monitors and reports compliance with the MEMP. 1 of 2 62

63. The HTM program participates in the Safety / EOC Committee's annual evaluation of the MEMP. 2 of 2 63

64. The HTM program performs internal benchmarking, monitoring multiple metrics over time. 1 of 3 64

65. The HTM program considers external benchmarking relative to HTM programs of similar organizations. 2 of 3 65

66. The HTM program is engaged in continuous performance improvement. 3 of 3 66

67. The HTM program benchmarks externally, identifies best practices, and implements performance improvements. 1 of 1 67

68. The HTM Program responds to product notifications and recalls related to medical equipment. 1 of 2 68

69. The HTM program reports equipment-related problems and use errors to the Safety / EOC Committee. 2 of 2 69

70. The HTM program is part of the organization's patient safety program. 1 of 4 70

71. The HTM program conducts The HTM program is part of the organization's patient safety program.no problem found" (NPF) and equipment failure analysis. 2 of 4 71

72. The HTM program manages the organization's process for handling equipment-related alerts and recalls. 3 of 4 72

73. The HTM program routinely participates in medical equipment- related incident investigations. 4 of 4 73

74. The HTM program routinely participates in medical equipment- related incident investigations. 1 of 2 74

75. The HTM program takes a leadership role in acquiring and distributing up-to-date knowledge on technology-related issues relevant to the organization's patient safety process. 2 of 2 75

76. The HTM program is represented on the Safety / EOC Committee. 1 of 2 76

77. The HTM program participates in environmental tours in patient care areas. 2 of 2 77

78. The HTM program has effective working relationships with clinical departments. 1 of 3 78

79. The HTM program has collaborative relationships with Information Technologies (IT) and Facilities. 2 of 3 79

80. The HTM program is represented on one or more of the following groups or committees: Capital, Facility design, Patient Safety, Nursing Education, Strategic Planning, Laser Safety, Product Evaluation, Quality Assurance, Performance Improvement. 3 of 3 80

81. The HTM program has a website for intra-organizational communications and reference. 1 of 3 81

82. The HTM program is an active communicator to key technical and management groups in the organization. 2 of 3 82

83. HTM program personnel provide leadership in national and regional professional associations. 3 of 3 83

84. Takeaways Nobody is perfect It is difficult to give ourselves a totally honest evaluation. There are lots of rationalizations for our lack of top performance. o it isn’t important o they won’t let us o our culture is different o blah, blah, blah Are these reasons or excuses? Are we just not making a compelling case? There is always room for improvement. 84

85. Thank You Questions? To download, Go to www.htma-sc.orgwww.htma-sc.org Join as an individual member (it is free) You will see “Download” menu selection. 3/30/201585 Patrick Lynch plynch@gmi3.complynch@gmi3.com 704-941-0116 www.htma-sc.org