Certification A License to Save Lives

Transcription

1 Certification A License to Save Lives Linda Jakeman, CRCST, ICP, MDR Consultant, Nova Scotia

2 Welcome South Health Campus Team These are your new Neighbours 2

3 Medical Device Reprocessing Technicians SHC 3

4 MDR Working Leaders and Case Cart Coordinators SHC 4

5 Management team 5

6 MDR Educator SHC 6

7 Certification A License to Save Lives Linda Jakeman, CRCST, ICP, MDR Consultant, Nova Scotia

8 Take Home for Today s presentation Understand the purpose of the Certification What is the background What does the research say What are the benefits in Certification How the CSA Certification Program is set up & measured What has the Alberta government done Resources for study Review of the exam preparation process Introduce CSA Web based study program 8

9 Purpose of the Certification Promote public health Create a national standard for Medical Device Reprocessing Technicians Lend authority and credibility to the profession Meet the needs of industry and regulators for relevant, standardized training and Reduce the number of hours needed for on-the-job training August

10 Background Significant interest from members for establishing a national CSA Personnel Certification program for Sterile Processing Department Technicians, January 2008, CSA Technical Committee on Sterilization Central Service Association of Ontario (CSAO) came forward as champions for this cause and initiated discussions with CSA to further explore the need CSA completed an internal assessment for discussion with committee, July 2008 Committee unanimously endorsed development of a Canadian national personnel certification program CSA began development of the program in September 2008 First Scheme Committee meeting took place in October

11 Research There is a compelling need for National Personnel Certification Vast body of literature documenting nosocomial (hospital acquired) infections ~1.7M infections resulting in ~99,000 deaths occur annually in the US Hospital Acquired Infections rose by 20% between 2000 and 2003 US based Health Grades Inc. report, May 2005 Canadian Nosocomial Infection Surveillance Program estimates 220,000 Canadians develop hospital acquired infections each year and 8,000 of them die in sheer numbers [nosocomial infections are] the 4th leading cause of death [in Canada] College of Physicians & Surgeons of Ontario,

12 Research 2006, PIDAC in Ontario released it s Best Practices for Cleaning, Disinfection and Sterilization in All Healthcare Settings document Health care providers need to ensure that the critical elements and methods of decontamination, disinfection and sterilization are incorporated into health care facility procedures. Sterilization or re-processing technicians must be able to demonstrate the competency (knowledge, skills and experience) required to carry out effective infection control Best Practices document recommends the completion of a recognized qualification / certification course in reprocessing practices within five years. 12

13 Benefits Positive patient outcomes Improved practitioner health and safety Labor force mobility Quality Assurance Increased performance Greater career opportunities Human resources support

14 CSA Standards Solutions Model Understanding the Needs Stakeholder Engagement Advisory Services Standards Development Consensus Standards Non-consensus Standards and documents Applying Standards Personnel Certification Education and Training Application Tools 14

15 Solutions: Personnel Certification Value of CSA Personnel Certification Programs Independent Verification Training Defined Knowledge & Skills Examination Certification Accreditation Process 15

16 Solutions: Personnel Certification Inclusive Development Process All participants have equal access Stakeholders have a voice Facilitator Psychometrics Subject Matter Experts CSA Subject Matter Expert Scheme Committee 16

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18 Personnel Certification Scheme CMDRT Certification Scheme Committee Job Task Analysis Examination Development Policies and Procedures 18

19 Solutions: Personnel Certification Personnel Certification is the assessment and formal recognition, through certification, of an individual s competence in meeting identified criteria for the safe handling, operation, and supervision of certain products and services. ISO (2003), General requirements for bodies operating certification of persons, formalizes this process. 19

20 CMDRT Factsheet

21 What has been done in Alberta? The Alberta Standards Alberta Health, Infection and Prevention Control Standards for Cleaning, Disinfection and Sterilization of Reusable Medical Devices for Health Care Facilities and Settings 21

22 The Standards for Alberta Section 10 Education and Training Personnel employed to work in MDR Areas, endoscopy departments or any department performing Sterilization of Reusable Medical Devices shall be certified in one of the following recognized certification programs:. 22

23 The Standards for Alberta CSA Certification for Certified Medical Device Reprocessing Technicians; or International Association of Healthcare Central Service Material Management Certification for Certified Registered Central Service Technicians 23

24 The Standards for Alberta If Personnel have not yet been certified in accordance with Section 10.1, the Organization shall have in place a written plan for each such Personnel to become certified by April 1,

25 The Standards for Alberta Where there are any Personnel performing Reprocessing tasks who are not employed to work in MDR Areas, endoscopy departments or any department performing Sterilization of Reusable Medical Devices pursuant to Section 10.1, the Organization shall ensure that such Personnel are Competent and Reprocessing is supervised. 25

26 The Standards for Alberta If an Organization does not employ any Personnel who are certified in accordance with Section 10.1, that Organization may enter into a written arrangement for Reprocessing with another Organization employing Personnel certified in accordance with Section

27 A qualified technician A qualified technician can perform the following activities without assistance, including (but not limited to): 1. Applying the principles of basic microbiology and infection prevention and control to decrease risk to both patients and staff during routine reprocessing procedures 2. Following written department policies and standard operating procedures 3. Handling and transporting contaminated medical devices 4. Decontaminating reusable medical devices 27

28 Education and/or Experience Pre-requisites OPTION 1: 1. Education: High School Graduate or equivalent (e.g. GED). AND 2. Training: Successful completion of a recognized Medical Device Reprocessing educational program. AND 3. Experience: Successful completion of a practicum and/or work experience in Medical Device Reprocessing totaling a minimum of 500 hours. Evidence of experience shall be provided via a performance checklist. OPTION 2: 1. Experience: Four thousand (4000) hours work experience in Medical Device Reprocessing within the last 5 years (equal to approximately.4 full time equivalent). Evidence of experience shall be provided via a performance checklist.

29 Recommended Resources for Study CSAO: The Manual for Reprocessing Medical Devices First Edition, and Companion Workbook, $ contact the C.S.A.O. office at: CBSPD: The Basics of Sterile Processing, 3 rd Edition, approx. $95.00 US Workbook for the Basics of Sterile Processing, 3 rd Edition, approx. $30.00 US Available from: CBSPD.

30 CSA Standards Z314.3 Effective Sterilization in Health Care Facilities by the Steam Process, approx. $105 CAD Z314.8 Decontamination of Reusable Medical Devices, approx. $95 CAD Contact CSA: Your MDR Department should have a copy on hand for your reference

31 PIDAC Best Practices for Cleaning, Disinfection and Sterilization of Medical Equipment/Devices in all Healthcare Settings, First published, April, 2006; Reviewed and Revised, February, 2010 PDF available at no charge from fectious/diseases/best_prac/bp_cds_2.pdf

32 PHAC Hand Washing Hand Washing, Cleaning, Disinfection and Sterilization in Health Care, Public Health Canada, 1998, under revision PDF available at no charge from: See also: CHICA-Canada, Hand Hygiene Resources:

33 SCGNA Reprocessing Flexible Endoscopes Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes, 2007.PDF available from Society of Gastroenterology Nurses and Associations, Inc. (SCGNA) from:

34 Secondary Resources CDC Disinfection and Sterilization Guidelines ORNAC, CSGNA, and CHICA Guidelines and Standards Legislation/Regulatory requirements Other CSA Standards, including: Z314.2 Effective Sterilization in Health Care Facilities by the Ethylene Oxide Process Z Selection, Use, Maintenance, and Laundering of Reusable Textile Wrappers, Surgical Gowns, and Drapes for Health Care Facilities Z Selection and Use of Rigid Sterilization Containers Z Warehousing, Storage, and Transportation of Clean and Sterile Medical Devices Z Management of Loaned, Shared and Leased Medical Devices

35 Body of Knowledge Exam Blueprint Section 1 Quality Systems - 4% 1.01 Describe the elements of a quality system that apply to daily practice. 35

36 Body of Knowledge Exam Blueprint Section 4 Decontamination Processes 16% 4.01 Describe how to select and use appropriate agents for decontamination Describe the different types and functions of decontamination equipment Describe how to collect, transport, and receive soiled medical devices Describe the steps for decontamination of soiled medical devices Describe how to use decontamination equipment Describe how to manually clean medical devices Given a scenario, identify incorrect practices in decontamination. 36

37 Body of Knowledge Exam Blueprint Section 5 High Level Disinfection - 10% 5.01 Identify devices that require high level disinfection Describe how to select and use appropriate chemicals for high level disinfection Describe how to manually high level disinfect semi-critical devices Describe how thermal high level disinfection can be achieved Describe the different types and functions of automated high level disinfecting equipment. 37

38 Body of Knowledge Exam Blueprint Section 6 Assembly - 22% 6.01 Describe how to sort, inspect, and test medical devices Distinguish between single-use, multi-use, and re-posable medical devices Describe how to assemble a set/tray Describe how to identify, select, and place chemical indicators Describe how to safely operate assembly area equipment Given a scenario, describe how to prioritize assembly workload Describe how to properly package medical devices for sterilization or other uses Given a scenario, describe appropriate assembly practices. 38

39 Body of Knowledge Exam Blueprint Section 7 Sterilization of Medical Devices - 18% 7.01 Explain the importance of medical device compatibility and validation Describe the different types of steam sterilizers and critical parameters needed for sterilization Identify the main components and describe the function of a steam sterilizer Explain how to manage load and operate steam sterilizers Describe the elements of a steam sterilization quality assurance program Describe the different types of low temperature sterilizers and critical parameters needed for each method Explain how to select, manage load, and operate low temperature sterilizers Not Used Give a scenario, identify appropriate responses to an adverse sterilization event. 39

40 Body of Knowledge Exam Blueprint Section 8 Storage, Transportation and Distribution 6% 8.01 Describe elements of storage and inventory management of medical devices Describe elements of transportation and distribution of medical devices Given a scenario, identify best practices in storage and transportation of medical devices. 40

41 Body of Knowledge Exam Blueprint Section 9 Flexible Endoscopes 5% 9.01 Describe how to reprocess flexible endoscopes and accessories Given a scenario, identify best practice for reprocessing flexible endoscopes. 41

42 am Blueprint 42

43 Application Process Each new application is valid for six (6) months from the time it is received. Program Fees: Initial Application Fee (non-refundable) $ CAD. Examination and Certification Fee $ CAD. Re-examination Fee $ CAD. Re-certification Fee by Exam or Continuous Learning $ CAD. 43

44 Re-certification is required Re-certification is required every 5 years OPTIONS: 1. Experience: The candidate to have a minimum of 4000 hours in a re-processing area during the 5 year term, AND 2. Training: Evidence of continuous learning (minimum 100 hours over the 5-year term) OR 3. Exam: Successfully challenge the certification exam 44

45 Medical Device Reprocessing Online Training CSA New Medical Device Reprocessing Online / Study Training program A Study Aid for personnel preparing to take the CSA CMDRT exam This is an excellent way to study as a group OR In the comfort of your home 45

46 Recommended Resources for Study Medical Device Reprocessing Online Training Self Paced Available 24/7 from the comfort of the student s own environment Less intimidating than classroom course Highly Interactive with immediate feedback Consistency of message to all learners Ease of tracking Cost effective deployment Shown to have higher retention and faster learning

47 Medical Device Reprocessing Online Training Objectives and Target Audience Demonstrate the direct impact of the MDRT s work on the safety of the patients Establish collective accountability in the implementation of the best practices The training is designed for all employees with Medical Device Reprocessing responsibilities Technicians, Supervisors Nurses Administrative Personnel Infection Control Professionals People interested in developing skills in MDR

48 Medical Device Reprocessing Online Training Course in a Nutshell 14 - One Hour Modules 5 Exams Course Glossary Course Online Library Videos, Real Life Pictures Interactive Quizzes Mix of Audio and Text Certificate of Completion granted upon a passing grade of 70% on the exams Various strategies for learning are utilized throughout the course Including: Traditional learning material Games (find the error) Case studies Exercises (auto correction and notation) Tests Video Suggested readings Aim for approximately 40 % of content to be interactive

49 Medical Device Reprocessing Online Training Course Library Accreditation Canada Qmentum 2012 Some of the Main Documents within the course Library

50 Medical Device Reprocessing Online Training Course Library Some of the Main Documents within the course Library

51 Medical Device Reprocessing Online Training English Language Version Development English Language version developed by CSA Content follows the basic Quebec developed course with modifications to ensure references, documents etc. meet the needs of the balance of the Canadian landscape Significant input from CSA Technical Committee members in the English Language course development Added a secondary market positioning: A Study Aid for personnel preparing to take the CSA CMDRT exam

52 Medical Device Reprocessing Online Training Scope of the Curriculum All the activities linked with the process of Medical Device Reprocessing: cleaning, disinfection, assembly, sterilization, storing according to the regulatory framework and CSA Standards of "exemplary current practices The physical and regulatory environment of the MDRD in Canada Basic elements of patient safety, health and safety in the workplace, risk management and the prevention of the infections

53 Medical Device Reprocessing Online Training Lesson Content Lesson 1: Introduction to Course Navigation HAI s in general, Canadian Statistics, Patient Stories and Impact of HAI s on their lives, Preventable HAI s and role of the importance of the role of the MDRT Lesson 2: Infectious Agents, Basic Microbiology, Modes of Infection Transmission Routine and Additional Precautions (PIDAC reference), PPE, Dress Code Lesson 3: Reducing your risks of transmission, Hand Hygiene, Immunization. Much more detail around PPE, sharps, what to do if something happens Lesson 4: Summative Exam #1 Accountability, Regulatory Environment in Canada, Health Canada, Accreditation Canada, CSA etc. Leads into US and International bodies i.e. CDC, ISO. Introduces concept of a Standard, AC and CSA, Shows the relevant Standards

54 Medical Device Reprocessing Online Training Lesson Content Lesson 5: Detail on the 3 Main CSA Standards, What they are, how to read them. Asks the student to work with the copy and walks them through the three documents togethersections, tables etc. Follows same idea with Qmentum Standard, Defines and Explains Accreditation. Speaks to the goals of the MDRD, introducing concept of customer service/quality and clients Lesson 6: Expands on service organization concept and expectations of an MDRD from the clients, leads into MDRT s role, responsibilities, tasks (job descriptions). Moves to work areas (dirty, clean, sterile) Video shows entire process start to finish. Access control, environmental conditions, Dress Code. One way traffic and cross contamination. Progression of Shift Lesson 7: Summative exam #2 Spaulding Classification and Patient Risk Categories, High Level Disinfection, High Temperature Sterilization, Low Temperature Sterilization, Medical Device examples that correspond. Cleaning, Decontamination, Disinfection and Sterilization definitions. Products/Method used for Critical/Semi-critical /Non-Critical MD s. Equipment used in MDRD. Stages in the MDR Process (10 min video Sacre Coeur Hospital). Breaks down into tasks by Stage

55 Medical Device Reprocessing Online Training Lesson Content Lesson 8: Takes a detailed look at the 12 Stages of MDR and breaks it down into 5 Task groupings, sorting, decontamination, assembly, sterilization, storage. Each Stage is expanded upon and demonstrated with equipment pictures, video, quizzes Lesson 9: Highlights importance of Standards and SOP s. Speaks to CSA and AC Standards to reinforce previous learning. Moves on to Flash Sterilization definition, when to use, additional risks, Stages of Flash Sterilization, examples of equipment, documentation and incident form Lesson 10: Summative Exam #3 Quality Control Systems, Risk Management Importance, Procedures, Assurance of Sterility, Manufacturers Obligations Lesson 11: Quality Assurance- continued. Installation Qualification, Operational Qualification, Process Challenge Device, Performance Qualifications, Chemical and Biological Indicators, Calculating Load Performance

56 Medical Device Reprocessing Online Training Lesson Content Lesson 12: Routine monitoring Mechanical, Chemical and Biological Indicators. In-depth look at each type including critical parameters, when and how to operate, photos. Administrative Checks, Load Recording, Failure Lesson 13: Traceability and Recall, objectives, method (computer or manual), flowchart, responsibilities, report examples Exam#4 Lesson 14: - Individual abilities soft skills communication, attitude. MDRD expectations competency, respect, communication, leadership, sample code of conduct for an MDRT. Teamwork, team behavior and impact on performance. Perception and Change - Exam #5

57 Contact Information Linda Jakeman, ICP, CMDRT, HSA L Jakeman Consulting Inc 594 West Porters Lake West Porters Lake, Nova Scotia B3G 1K5 Phone: Cell: Lin.jakeman@gmail.com CSA Group Learning Institute: training@csagroup.org To purchase or further details: shop.csa.ca Phone:

58 Thank You 58