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

Slides:



Advertisements
Similar presentations
[Organisation’s Title] Environmental Management System
Advertisements

Patrick K. Lynch CBET, CCE, fACCE, CPHIMS, CHTS-PW Global Medical Imaging (GMI)
Medsafe – GMP update / release for supply / communicating quality issues Derek Fitzgerald Manager, Compliance Management 11 July 2013 RACI Pharmaceutical.
MODULE B - PROCESS B1. ASME Organizational Structure B2. Standards Development: Staff and Volunteer Roles and Responsibilities B3. Conformity Assessment:
1 Assessment: Norms and Accreditation. Assessment: Norms and Accreditation-Module 11 2 Learning Objectives At the end of this module, participants will.
Certification Patrick K. Lynch CBET, CCE, CPHIMS, HIT Pro/PW Global Medical Imaging BMET Board of Examiners – Chair – BMET Board of Examiners.
QA Programs for Local Health Departments
ORGANIZATION. 2 Problem scenario  Develop an organizational chart for your laboratory showing lines of authority from the head of the organization to.
ORGANIZATION. 2 Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service Facilities & Safety.
AACE Goals Goals as identified by AACE’s Board of Directors for
Patrick K. Lynch CBET, CCE, fACCE, CPHIMS, CHTS-PW.
Contractor Safety Management
MFRPS Lesson Learned North Carolina
LAV Process Explained: Equipment Maintenance Medical Equipment and Logistics Solutions Directorate Naval Medical Logistics Command.
Environmental Management Systems An Overview With Practical Applications.
Laboratory Personnel Dr/Ehsan Moahmen Rizk.
Overview Lesson 10,11 - Software Quality Assurance
Quality evaluation and improvement for Internal Audit
Standar-standar yang melibatkan radiologi
Continuing Competence in Nursing
Quality Assurance/Quality Control Policy
Medical Technology Management
Environmental Management Systems The ISO Approach Initial Environmental Review & Gap Analysis Presented by: NC Division of Pollution Prevention.
Personnel Basic Principles of GMP Workshop on
5.2 Personnel Use competent staff Supervise as necessary
4. Quality Management System (QMS)
The Molecular Diagnostics Research Laboratory University of Malaya Development and Implementation of a Quality System The Molecular Diagnostics Research.
Technology Assesment (TA) by Mohd Yusof Baharuddin.
Top Tactics for Maximizing GMP Compliance in Blue Mountain RAM Jake Jacanin, Regional Sales Manager September 18, 2013.
4. Quality Management System (QMS)
ISO 9001:2015 Revision overview - General users
CLINICAL ENGINEERING part(3) Dr. Dalia H. Elkamchouchi.
EHS Management System Elements
Regulatory Overview.
by Joint Commission International (JCI)
CHAPTER 5 Infrastructure Components PART I. 2 ESGD5125 SEM II 2009/2010 Dr. Samy Abu Naser 2 Learning Objectives: To discuss: The need for SQA procedures.
Organization Mission Organizations That Use Evaluative Thinking Will Develop mission statements specific enough to provide a basis for goals and.
Careers, Roles, and Responsibilities. Duties and Responsibilities The role of CE started in early 1970s. The need for medical technology management arose.
Organization and Implementation of a National Regulatory Program for the Control of Radiation Sources Staffing and Training.
Accreditation Jill Humes, BSN, RN, Vascular Access Manager Renal Intervention Center, L.L.C.
Fourth Annual Medical Research Summit Concurrent Session 4.05 – Managing CROs and SMOs from a Compliance Perspective Michael SwiatochaAprill 23, 2004.
Certified Healthcare Technology Manager (CHTM) Patrick K. Lynch CHTM, CBET, CCE.
Risk Management, Assessment and Planning Committee III-4.
LINC 07 Administrators Conference Successful Board Partnerships Nora V. Murrant, FCA, FCBV.
Communicating Effectively with the C-Suite Kenneth Maddock, BSEET Vice President of Clinical Engineering and Telecomm Services, Baylor Health Care System.
The Expectation Triad Healthcare Engineering Consultants Regulatory Compliance: “Ensuring that all of the required standards are being met”
Technology Management (TM) Mohd Yusof Baharuddin.
Presented by: Ken Imler Sr. Vice President RAQA Arrow International Working with Suppliers: Forming Strategic Alliances to Accelerate Compliance & Improve.
Important informations
Review of Midwifery Supervision Workshop 20 th April 2015 ‘Revalidation’ Are you ready?
Staffing and training. Objectives To understand approaches to the development of strategies and policies for staffing of a Regulatory Authority including.
Consultant Advance Research Team. Outline UNDERSTANDING M&E DATA NEEDS PEOPLE, PARTNERSHIP AND PLANNING 1.Organizational structures with HIV M&E functions.
Standard 10: Preventing Falls and Harm from Falls Accrediting Agencies Surveyor Workshop, 13 August 2012.
The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress Presented by J. Glenn George Thursday, March 29, 2007 Day II – Track.
This Lecture Covers Roles of –Management –IT Personnel –Users –Internal Auditors –External Auditors.
Copyright © 2007 Pearson Education Canada 9-1 Chapter 9: Internal Controls and Control Risk.
There are 6 main components to Care Provider’s Committed to Quality Program: Visionary Leadership Mission Statement Customer Satisfaction Employee Satisfaction.
WORKSHOP ON ACCREDITATION OF BODIES CERTIFYING MEDICAL DEVICES INT MARKET TOPIC 9 CH 8 ISO MEASUREMENT, ANALYSIS AND IMPROVEMENT INTERNAL AUDITS.
Beyond the Biomed Shop Walls: How the biomed technician affects the patient experience Carol L. Wyatt.
CLINICAL ENGINEERING.
Hospital Accreditation Documentation Process & Standard Requirements
THEME: EMPOWERING FACILITY MANAGEMENT AND HEALTHCARE TECHNOLOGY IN KENYA TOPIC:MEDICAL EQUIPMENT MANAGEMENT DATE’13/11/2013 BY MILLICENT ALOOH.
GCP (GOOD CLINICAL PRACTISE)
CLINICAL ENGINEER: PLACE, ROLE AND FUTURE CHALLENGES A Presentation To The 1 st Joint East African Scientific Conference (AMEK & UNAHME) By: Gordon A.
Pipeline Safety Management Systems
How Does Your HTM Program Score? A, B, C, D or F?
ISO/IEC
HOW BEST CAN WE MANAGE MEDICAL EQUIPMENT By Khalif D.Mohamud BMET-GCRH
Clinical Engineering Lecture (3).
World Health Organization
Presentation transcript:

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

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) 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The HTM program monitors productivity. 2 of 3 28

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Thank You Questions? To download, Go to Join as an individual member (it is free) You will see “Download” menu selection. 3/30/ Patrick Lynch