1. How Does Your HTM Program Score? A, B, C, D or F?
Patrick K. Lynch
CHTM, CBET, CCE, CCE, CPHIMS
Lynch Problem Solving & Consulting

2. Who am I? CHTM, CBET, CCE, CPHIMS, CHTS-PW, fACCE 42 years in Biomed
Managed large In-house, ISO and corporate Biomeds
Active in certification of BMETs and CEs
1st Pres of NCBA (North Carolina branch)
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
Write a daily blog for the HTMA-OH -
Train Biomeds in Developing Countries
Medical Foundation (Guatemala)
Provide them with tools, test equipment, manuals, supplies
Biomeds Without Borders – My not-for-profit
Writes monthly for 24x7 and BI&T (AAMI)

3. Biomeds Without Borders

4. Why Evaluate Our Programs?
To find our weaknesses (before other find them)
To get better
To save ourselves from being outsourced
To provide our employers better value
To feed our ego by proving that we are as good as we believe ourselves to be
Curiosity – to see how we stack up to the rest of our field.

5. HTM Levels - Overview Program Scope 1 3 Regulatory Compliance 2
Fundamental
Progressive
Advanced
Program Scope 1 3
Regulatory Compliance 2
Program Management 5
Equip Maintenance & Tech Mgmt 4
Personnel Mgmt & Staff Development
Tactical & Strategic Planning 6
Performance Montoring & Improvement
Patient & Staff Safety
Internal & External Relationships

6. 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.
it isn’t important
they won’t let us
our culture is different
blah, blah, blah
Are these reasons or excuses?
Are we just not making a compelling case?
There is always room for improvement.

7. 1. Program Scope Fundamental
HTM Program maintains MOST of the general biomedical equipment in the organization.
General biomedical equipment includes medical devices that provide monitoring, diagnosis, treatment or life support but excludes imaging equipment, therapeutic radiology equipment, clinical laboratory equipment, and other advanced technologies that are often managed by other departments.
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8. 1. Program Scope PROGRESSIVE
The HTM program maintains ALMOST ALL general medical equipment.
The HTM program maintains or manages some advanced medical technology (e.g. imaging, laboratory).
Compared to Level 1 programs, Level 2 programs cover essentially all biomedical equipment, either by direct maintenance or by management of services provided by others.
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9. 1. Program Scope ADVANCED
The HTM program manages all HTM-relates costs for the organization.
All service costs related to medical technology are managed by the HTM program. This includes services provides by both internal and outside service providers, as well as healthcare technologies throughout the organization. An example of an Advanced HTM practice: ALL SERVICE COSTS AND OUTSIDE VENDOR COSTS RELATED TO TECHNOLOGY MANAGEMENT ARE CENTRALIZED IN THE HTM BUDGET.
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10. 2. Regulatory Compliance Fundamental
The HTM program achieves compliance with accreditation standards and government regulations.
In the United States, the most prominent accreditation organization is The Joint Commission (TJC). However, the HTM program should be aware of any other equipment-related standards and regulations that apply to their organizations.
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11. 2. Regulatory Compliance PROGRESSIVE
… has up-to-date knowledge of applicable codes, standards and regulations.
...implements cost-effective compliance strategies.
Many voluntary AAMI, IEC, ISO and other standards exist in addition to the required accreditation standards and state laws that a progressive HTM program needs to understand and keep track of.
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12. 2. Regulatory Compliance ADVANCED
HTM program leadership works proactively with regulatory agencies and standards organizations to develop and update medical technology-related regulations, codes and standards.
The leadership of the HTM program does more than the mandatory and other requirements; it is also involved in shaping future HTM standards.
Examples include: establishes lines of communications with regulators and accrediting agencies, supports advocacy efforts by professional associations regarding codes, standards and regulations.
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13. 3. Program Management Fundamental
… has a current, written medical equipment management plan (MEMP).
… an equipment control program in place with a complete inventory.
Activities of the HTM program should be based upon a plan that summarizes its responsibilities and describes how it meets those responsibilities.
… uses a Computerized Maintenance Management Program (CMMS) for inventory, maintenance scheduling, and maintenance history.
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14. 3. Program Management PROGRESSIVE
... distinct organizational entity with a qualified, dedicated manager and a separate budget.
… manager has access to financial information needed to carry out these responsibilities.
… calculates the Cost of Service Ratio (COSR).
The HTM manager needs to be qualified and focused on HTM. To effectively manage a budget, it needs to be separate and distinct from other (non-HTM) budgets.
… uses a CMMS with a productivity and cost analysis capabilities.
… has adequate space, tools and equipment.
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15. 3. Program Management ADVANCED
… operates like a business.
… monitors productivity.
… CMMS has extensive analytical and technology management features.
Whether internal or external, profit or not-for-profit, the HTM program functions as a business and should be managed as such. Examples include; prepares a comprehensive annual report, makes cost-effective long-term long-term business decisions, is aware of the practices and costs of competing organizations.
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16. 4. Equipment Maintenance & Technology Management Fundamental
… written procedures for safety and functional testing and preventive maintenance.
… has written schedules for inspecting and maintaining medical equipment.
Procedures should include functional testing as well as electrical and other types of safety testing. These procedures should be based upon manufacturer recommendations and recognized professional resources, such as those provided by ECRI Institute.
… process for regular calibration of test equipment.
… has the ability to readily obtain repair parts.
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17. 4. Equipment Maintenance & Technology Management PROGRESSIVE
written risk assessment of all new device types.
Maintenance procedures & schedules based on recognized resources and organizational data.
Program includes management of stock parts
MEMP Inventory accuracy verified periodically by a sample physical inventory.
As new equipment is purchased, it needs to go through a formal process (e.g., policy, flowchart) to determine which scheduled maintenance strategy (e.g., interval-based, run-to-fail, hours-based, sampling), if any, should be used for that device.
Service contracts include provisions for periodic auditing of vendor qualifications.
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18. 4. Equipment Maintenance & Technology Management ADVANCED
… manages medical technologies throughout the entire equipment life cycle.
… uses evidence-based maintenance strategies.
… integrates RM (risk management) and QA (quality assurance) into HTM.
Medical technology must be managed through all lifecycle stages: assessment, prepurchase evaluation, purchase, installation, acceptance, repair & maintenance, decommissioning and disposal. Examples include: sustainability is included in technology assessment and evaluation, interface capability is included in technology assessment and evaluation.

19. 5. Personnel Management & Staff Development Fundamental
… personnel have appropriate education, experience, credentials and values.
The provision of safe and effective medical equipment depends upon well-qualified personnel in the HTM program.
… job descriptions and job titles conform to professional standards.
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20. 5. Personnel Management & Staff Development PROGRESSIVE
… has a process for orienting new staff members.
… has a budgeted continuing education education program.
The orientation program is documented and includes competency review for all core job duties.
… supports participation in regional or national professional associations.

21. 5. Personnel Management & Staff Development ADVANCED
… reports directly to the Vice president or C-suite level.
… has a qualified clinical engineer on staff.
To have broad organization-wide perspective and visibility, the HTM program needs to report to senior leadership. Examples of Advanced HTM practice include: routine access to senior leadership provides opportunity to maximize contribution to organization objectives such as strategic technology planning.
At least 30% of the technical staff holds a professional certification.
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22. 6. Tactical & Strategic Planning Fundamental
… is regularly included in the process for selection and the acquisition of medical equipment.
The experience and technical knowledge of the HTM program is essential for effective medical equipment planning for the organization.
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23. 6. Tactical & Strategic Planning PROGRESSIVE
… is involved in capital planning and replacement equipment planning.
… is involved in equipment planning for construction and renovation projects.
… is involved in all purchases of new equipment.
HTM programs can provide healthcare organizations with a vast amount of information on equipment performance, safety, and reliability. Clinical Engineering experience is critical to cost-effective medical equipment planning for replacement and new construction.
… records data for technology planning in the CMMS.
… ensures that user and service training is included with new equipment purchases.
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24. 6. Tactical & Strategic Planning ADVANCED
… has a leadership role in important clinical technology decisions.
… actively participated in strategic (long-term) technology planning and assessment.
… provides guidance on healthcare technology integration in all construction and renovation.
With regard to HTM technology decisions, the level 3 program should move beyond participation in the process and adopt a leadership role.
An example of Advanced practice is: serving as chair or co-chair with an IT professional of technology acquisition committees.
… collaborates on the selection of all medical device-related technologies.
… takes leadership and active participant roles in CE-IT convergence issues.
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25. 7. Performance Monitoring & Improvement Fundamental
… regularly monitors and reports compliance with the MEMP.
… participates in the Safety / EOC Committee's annual evaluation of the MEMP.
At a minimum, performance monitoring should include tracking of on-time completion of scheduled maintenance, but other metrics should be considered.

26. 7. Performance Monitoring & Improvement Fundamental
… participates in the Safety / EOC Committee's annual evaluation of the MEMP.
… participates in the Safety / EOC Committee's annual evaluation of the MEMP.
The evaluation should be multi-disciplinary and based on data.

27. 7. Performance Monitoring & Improvement PROGRESSIVE
… performs internal benchmarking, monitoring multiple metrics over time.
…. considers external benchmarking relative to HTM programs of similar organizations.
… is engaged in continuous performance improvement.
Internal benchmarking allows comparison of key quantitative indicators such as those listed and the COSR, year after year.

28. 7. Performance Monitoring & Improvement ADVANCED
… benchmarks externally, identifies best practices, and implements performance improvements.
Benchmarking externally provides comparison data from comparable level 2 and level 3 organizations that can be used for performance improvement planning. An example of an advanced practice: participation in a national benchmarking database.
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29. 8. Patient & Staff Safety Fundamental
… responds to product notifications and recalls related to medical equipment.
… reports equipment-related problems and use errors to the Safety / EOC Committee.
HTM Program responsiveness allows the organization to quickly implement corrective actions.

30. 8. Patient & Staff Safety PROGRESSIVE
… is part of the organization's patient safety program.
... conducts no problem found" (NPF) and equipment failure analysis.
HTM staff can make significant contributions to patient safety projects through technology assessment, user collaboration, incident investigation, and other activities. Examples include dose error reduction, "smart" pump error log analysis, analysis of use errors, and review of equipment incident reports.
… manages the organization's process for handling equipment-related alerts and recalls.
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31. 8. Patient & Staff Safety ADVANCED
… routinely participates in medical equipment-related incident investigations.
… takes a leadership role in acquiring and distributing up-to-date knowledge on technology-related issues relevant to the organization's patient safety process.
The HTM program obtains available sources of technology-related information and related literature, reviews them for applicability, and distributes to key individuals across the organization to improve individual awareness and preparedness for upcoming decision making.
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32. 9. Internal & External Relationships Fundamental
… is represented on the Safety / EOC Committee.
… participates in environmental tours in patient care areas.
The key value of this committee is its interdisciplinary nature, which brings multiple perspectives to bear on problem identification and resolution.
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33. 9. Internal & External Relationships PROGRESSIVE
The HTM program has effective working relationships with clinical departments.
… has collaborative relationships with Information Technologies (IT) and Facilities.
… 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.
HTM management should meet regularly with key clinical staff.
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34. 9. Internal & External Relationships ADVANCED
… has a website for intra-organizational communications and reference.
… is an active communicator to key technical and management groups in the organization.
Modern organizations use Internet and intranet tools such as websites to communicate. An example of an advanced HTM practice: the internal HTM website communicates technology-related information to HTM program "customers" and highlights "hot topics" and other timely information.
personnel provide leadership in national and regional professional associations.

35. 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.
it isn’t important
they won’t let us
our culture is different
blah, blah, blah
Are these reasons or excuses?
Are we just not making a compelling case?
There is always room for improvement.

36. Order the complete evaluation
FREE from AAMI
HTM Levels Guide

37. Thank You Questions? To download, Go to www.htma-sc.org
Join as an individual member (it is free)
You will see “Download” menu selection.
Patrick Lynch
12/7/2016