Certification– A License to Save Lives · Learning Institute Course Title Module # Certification– A License to Save Lives Linda Jakeman, CRCST, ICP, MDR Consultant, Nova Scotia

Learning Institute Course Title Module #

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


Welcome South Health Campus Team

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• These are your new Neighbours


Medical Device Reprocessing Technicians SHC

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MDR Working Leaders and Case Cart Coordinators SHC

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Management team

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MDR Educator SHC

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


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

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Learning Institute Course Title Module # August 25

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


Background

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• 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 2008


Research

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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, 2005


Research

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• 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.”


Benefits

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


CSA Standards Solutions Model

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Standards Development• Consensus Standards• Non-consensus Standards

and documents

Understanding the Needs• Stakeholder Engagement• Advisory Services

Applying Standards • Personnel Certification• Education and Training• Application Tools


Solutions: Personnel Certification

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Independent Verification

Accreditation Process

TrainingDefined

Knowledge& Skills

Examination Certification

Value of CSA Personnel Certification Programs



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• Inclusive Development Process• All participants have equal access• Stakeholders have a voice

Facilitator

Psychometrics

CSA SubjectMatter Expert

Scheme Committee

Subject Matter Experts

Learning Institute Course Title Module # 17


Personnel Certification Scheme

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CMDRTCertification

Scheme Committee

Job Task AnalysisExaminationDevelopment

Policiesand

Procedures



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Personnel Certification isthe assessment and formalrecognition, through

certification, of an individual’s competence in meeting identified criteria for the safe handling, operation, and supervision of certain products and services. ISO 17024 (2003), General requirements for bodies operating certification of persons, formalizes this process.


CMDRT Factsheet


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

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The Standards for Alberta

Section 10 Education and Training

10.1. 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:

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10.1.1. CSA Certification for Certified Medical DeviceReprocessing Technicians;

or

10.1.2. International Association of Healthcare Central Service Material Management Certification for Certified Registered Central Service Technicians

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10.2. 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, 2015.

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10.4. 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.

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10.3. 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 10.1.

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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

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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.


Recommended Resources for Study

CSAO: The Manual for Reprocessing Medical Devices –First Edition, and Companion Workbook, $195.00contact the C.S.A.O. office at: [email protected]

CBSPD: The Basics of Sterile Processing, 3rd Edition, approx. $95.00 US

Workbook for the Basics of Sterile Processing, 3rd Edition, approx. $30.00 USAvailable from: CBSPD. www.sterileprocessing.org

http://www.sterileprocessing.org/


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: www.shopcsa.ca

Your MDR Department should have a copy on hand for your reference

http://www.shopcsa.ca/


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 fromhttp://www.health.gov.on.ca/english/providers/program/infectious/diseases/best_prac/bp_cds_2.pdf

http://www.health.gov.on.ca/english/providers/program/infectious/diseases/best_prac/bp_cds_2.pdf

http://www.health.gov.on.ca/english/providers/program/infectious/diseases/best_prac/bp_cds_2.pdf


PHAC – Hand Washing

• Hand Washing, Cleaning, Disinfection and Sterilization in Health Care, Public Health Canada, 1998, under revision

• PDF available at no charge from:http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/98pdf/cdr24s8e.pdf

See also: CHICA-Canada, Hand Hygiene Resources:http://www.chica.org/links_handhygiene.html

http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/98pdf/cdr24s8e.pdf

http://www.chica.org/links_handhygiene.html


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:

http://www.sgna.org/Resources/3_stdofinfectionFINAL1208_2.pdf

http://www.sgna.org/Resources/3_stdofinfectionFINAL1208_2.pdf


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

– Z314.10 Selection, Use, Maintenance, and Laundering of Reusable Textile Wrappers, Surgical Gowns, and Drapes for Health Care Facilities

– Z314.14 Selection and Use of Rigid Sterilization Containers– Z314.15 Warehousing, Storage, and Transportation of Clean and Sterile Medical

Devices– Z314.22 Management of Loaned, Shared and Leased Medical Devices


Body of Knowledge – Exam Blueprint

Section 1 Quality Systems - 4%

1.01 Describe the elements of a quality system that apply to daily practice.

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Section 4 Decontamination Processes 16%

4.01 Describe how to select and use appropriate agents for decontamination.4.02 Describe the different types and functions of decontamination equipment.4.03 Describe how to collect, transport, and receive soiled medical devices.4.04 Describe the steps for decontamination of soiled medical devices.4.05 Describe how to use decontamination equipment.4.06 Describe how to manually clean medical devices.4.07 Given a scenario, identify incorrect practices in decontamination.

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Section 5 High Level Disinfection - 10%

5.01 Identify devices that require high level disinfection.5.02 Describe how to select and use appropriate chemicals for high level

disinfection.5.03 Describe how to manually high level disinfect semi-critical devices.5.04 Describe how thermal high level disinfection can be achieved.5.05 Describe the different types and functions of automated high level disinfecting

equipment.

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Section 6 Assembly - 22%

6.01 Describe how to sort, inspect, and test medical devices.6.02 Distinguish between single-use, multi-use, and re-posable medical devices.6.03 Describe how to assemble a set/tray.6.04 Describe how to identify, select, and place chemical indicators.6.05 Describe how to safely operate assembly area equipment.6.06 Given a scenario, describe how to prioritize assembly workload.6.07 Describe how to properly package medical devices for sterilization or other

uses.6.08 Given a scenario, describe appropriate assembly practices.

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Section 7 Sterilization of Medical Devices - 18%

7.01 Explain the importance of medical device compatibility and validation.7.02 Describe the different types of steam sterilizers and critical parameters needed

for sterilization.7.03 Identify the main components and describe the function of a steam sterilizer.7.04 Explain how to manage load and operate steam sterilizers.7.05 Describe the elements of a steam sterilization quality assurance program.7.06 Describe the different types of low temperature sterilizers and critical

parameters needed for each method.7.07 Explain how to select, manage load, and operate low temperature sterilizers.7.08 Not Used.7.09 Give a scenario, identify appropriate responses to an adverse sterilization

event.

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Section 8 Storage, Transportation and Distribution 6%

8.01 Describe elements of storage and inventory management of medical devices.8.02 Describe elements of transportation and distribution of medical devices.8.03 Given a scenario, identify best practices in storage and transportation of

medical devices.

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Section 9 Flexible Endoscopes 5%

9.01 Describe how to reprocess flexible endoscopes and accessories.9.02 Given a scenario, identify best practice for reprocessing flexible endoscopes.

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am Blueprint

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Application Process

• Each new application is valid for six (6) months from the time it is received.

• Program Fees:• Initial Application Fee (non-refundable) $ 68.00 CAD.• Examination and Certification Fee $ 195.00 CAD.• Re-examination Fee $ 95.00 CAD.• Re-certification Fee by Exam or Continuous Learning $ 263.00 CAD.

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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,

AND2. Training: Evidence of continuous learning (minimum 100 hours over the

5-year term)

OR3. Exam: Successfully challenge the certification exam

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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

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Recommended Resources for Study

• 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



• 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


Objectives and Target Audience



• 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

Course in a Nutshell

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


Some of the Main Documents within the course Library

Accreditation Canada Qmentum 2012


Course Library


Some of the Main Documents within the course Library


Course Library


• 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


English Language Version Development



• 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

Scope of the Curriculum


• 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


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 together-sections, 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


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


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


Lesson Content


Contact Information

• Linda Jakeman, ICP, CMDRT, HSAL Jakeman Consulting Inc594 West Porters LakeWest Porters Lake, Nova ScotiaB3G 1K5

Phone: 1-902-827-5360Cell: [email protected]

• CSA Group Learning Institute:– [email protected]

• To purchase or further details:– shop.csa.ca

• Phone:– 1-800-463-6727

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mailto:[email protected]


Thank You

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