“The Official Newsletter of the CBSPD, Inc.”
A Message from the Executive Director By: Nancy Chobin, RN, AAS, ACSP, CSPM
The CBSPD Board of Directors have been hard at work to continually improve the certification process for candidates. In November, 2012 the CBSPD administered the revised technician exam. The content of the exam was updated to reflect the Job Analysis survey (JAS) conducted in 2012. Updating the exam contents of all exams is a requirement of the National Commission for Certifying Agencies (NCCA). The NCCA accreditation for the technician exam was re-submitted to NCCA in January 2013. In August, 2012 the CBSPD merged the Certified Sterile Processing Supervisor and Certified Sterile Processing Manager examinations into one credential called “Certified in Sterile Processing Management”. This decision was based upon data collected in a Job Analysis survey conducted by the CBSPD in 2012. The survey revealed minor differences in the responsibilities for these two positions. A consensus from the survey participants indicated that the exams should be merged. It is important to understand that if you are currently certified as a CSPDS or CSPDM your current certification is NOT affected by this new credential. As long as you continue to meet the re-certification criteria, you can keep your original credential and do not have to re-take an exam. The Flexible Endoscope reprocessor exam and the Ambulatory Surgery tech exams were also updated based upon a new Job Analysis performed by the CBSPD. The revised exams were administered in August 2012. So, why does the CBSPD go through the expense and additional work to continually update their exams? Because it is the right thing to do. The National Commission for Certifying Agencies requires a Job Analysis survey be performed every five years (more often is indicated) to accurately reflect the exam content. Frequently, technology and information changes; therefore these changes need to be included in the exam content. According to Knapp and Associates (Princeton, NJ) “Of course, it cannot be forgotten that certification is a business that has standards with which it must comply. Business goals should never trump the psychometric requirements. More importantly, business goals should not detract from accomplishing the certifier’s mission. When a certifier makes a decision, it’s not purely a business decision in terms of profit and loss, but rather consideration also must be given to the sustainability of the program and its mission. The mission of the CBSPD is to protect patients through COMPETENCY BASED certification examinations. The CBSPD Board of Directors met in October 2012 to continue to move the mission of the CBSPD forward. Remember, “Quality is our commitment….patient safety is our goal”. The CBSPD’s internationally recognized certification programs continue to expand to help achieve this goal throughout the world.
VOLUME 17, ISSUE 2
AAMI Update ST-79 (2012 update) was published last fall and is available from www.aami.org. The next update will be in 2014. The Technical Information report document on Flexible Endoscopes continues to be developed. The Committee will continue to work on the document at the May AAMI Meeting. New Committees working on new documents includes a document on Human Factors (that influence how items are processed); standardized instructions for use and Loaner instrumentation. The 2013 updates for the Chemical Sterilization and High Level Disinfection document and Containment Devices standards should be published this spring. The AAMI Benchmarking tool has been expanded to include an excellent productivity tool. This tool will be very helpful to determine the staffing in your department based upon your service levels. Have a safe and good summer. And remember the importance of your job….the patient and surgeon are depending on you! SEPARATE NOTE: Condolences to the family of the late Clarence (Clare) Daly who passed away in 2012. Clare was a long-time ally to sterile processing. For many years he taught a sterile processing course in Chicago. He will be sorely missed. ______________________________________
Continuing Education (CEU) Report By: Teckla “Tam” Maresca/Nora Wikander: CEU Committee Co-Chairs
The CEU Committee reminds everyone to obtain CEU’s on an ongoing basis. There are so many ways to obtain your credits, journal in-services, departmental in-services, manufacturer inservices, on-line webinars, on-line in-services and outside seminars to list a few. Just be sure what you choose to use is relevant to the exam content outline for your certification level. When the committee reviews submissions for approval we use those outlines as a base, program contents need to relate to sterile processing activities. Time frames for approval are based on a sixty minute hour. For multi hour seminars time is not awarded for breaks or vendor exhibits. Keeping track of your approved hours is your responsibility. Every program (seminar), in-service or self-study you use must be approved by the CBSPD CEU Committee. If you do not have an approval code or a statement that the program is pre-approved (most journal articles are pre-approved) you need to submit the information to the CEU Committee for review. When attending seminars, make sure that your certificate of attendance has a CBSPD approval number and approved contact hours. Continued on Page 2
AAMI Update: Front Cover CEU Report: Front Cover Pre-approved In-service: Pg. 2
2013 Exam Dates: Pg. 3 Important Web Links: Pg. 4 2012 Exam Stats: Back Cover
CEU Report Continued Contacting the seminar organizers prior to attendance and asking if they have applied for approval can avoid you having to submit the program for review after attending. Remember that you will be required to submit your original certificate of attendance when you are re-certifying. You can also submit a continuing ceu record sheet that is signed by your manager (on hospital letterhead) which proves you have attended the program. The record sheet can be downloaded from our web links page on our website. We encourage you to submit requests for approvals on line through our website www.sterileprocessing.org. Make sure you complete the entire application and once it has been submitted that you receive a confirmation sheet that the submission went through. Save this confirmation until you receive the approval letter. If you have not received a response to your submission within 6 weeks please contact the CBSPD office. It will be helpful for you to have the original submission on hand that could then tell us when it was originally submitted. Your response will be sent to you via the e-mail address you provide with a PDF file attached. Open the attachment and print the letter and file it with your re-certification information so it is available when you complete your re-certification application. You can submit a request for review for any of the manufacturer’s in-service’s that have not already received an approval code from us by submitting the information to the CEU Committee. Make sure you keep the original certificate since the original is required when you send in your re-certification information (unless you are using the computerized CEU record sheet found on our website). The major reason for requiring continuing education is to keep you updated with the latest trends, processes and requirements for performing our jobs. The same program/in-service/self-study can only be used once in a five year re-certification process. The printed self-study programs are approved for a five year time frame from the original publication date. Be aware of the original publication date so you are not submitting something that is not past the approval time. For example: Your re-certification is due in 2012 – the self-study you are using was approved in 2006 – you must have completed the self-study by 2011 in order to use it for your re-certification. The CEU committee is dedicated to assisting all our certificants to receive credit for their on-going education and have added personnel to assist us in continuing this commitment. Celebrate your certification and what it means, keep striving to be better by seeking out the information you need to keep yourself updated. While you are doing that you are gaining credits for recertification. Keep your records current to make the process easier. If you have any questions about the Continuing Education Process please submit them to the CBSPD office and someone from the Committee will be happy to answer them. NOMINATIONS NEEDED FOR BOARD POSITION OF SURGICAL INSTRUMENT SPECIALIST MEMBER.
The CBSPD currently has an open position on the Board of Directors. If you are certified as a CBSDP surgical instrument specialist or know of someone who is a CBSPD certified surgical instrument specialist, submit the name for consideration as a Board member representing this credential. You need to be currently certified as a surgical instrument specialist and willing to serve a 3-year term attending one Board of Directors meeting a year (expenses paid). Please email our office at [email protected]
and tell us the name of the person you are nominating as well as why they would be a good board member for the CBSPD. www.sterileprocessing.org
2013 CBSPD Board of Directors Executive Commissioners (Non-Voting) Nancy Chobin, R.N., CSPDM, Executive Director Teckla “Tam” Maresca, L.P.N., CSPDM; Co-Chairperson, CEU Review Committee Nora Wikander, R.N., CSPDM; Co-Chairperson, CEU Review Committee Martha Young, CSPDT, International Liaison Rep. M. Eleanor Reilly, R.N., CSPDM, Board Member Emeritus Margaret Ryan, R.N., CSPDM, Board Member Emeritus Sue McManus, R.N., CSPDM; Board Member Emeritus, Item Review Committee Member Karen Swanson, L.P.N., CSPDM; Test Development Committee Chairperson
CBSPD Voting Board Representatives Nyla "Skee" Japp, R.N., PhD, CSPDM, Management, CEU Review Committee Marie Long, CSPDT, Technician, CEU Review Committee Gail Law, R.N.,CASSPT, Ambulatory Surgery Tech Karen Zervopoulos, R.N., CFER, GI Scope Paul Letersky, B.A., J.D., Public Member ______________________________________________________________________________
SPS Medical Scholarships
The Board of Directors of the CBSPD congratulates everyone that was awarded scholarships in 2012 from SPS Medical. A list of all winners is posted on our website on the CS Scholarships page (www.sterileprocessing.org/sps_medical.htm). SPS Medical will continue to offer their scholarships for all of the CBSPD exams. An SPS application can be obtained on our CS Scholarships page link above, or by calling SPS at 1-800-722-1529. ________________________________________ PRE-APPROVED IN-SERVICE Rigid Container Systems (From then to Now) By: Angela Jensen, CSPDS
Rigid containers were first developed in Germany in the mid1890s. These original containers were made of stainless steel, but chrome-plated containers had become the container of choice by the early 1900’s. The main function of these early containers was to transport sterile instruments and dressings. In that era it was not unusual for sterile supplies to be kept in a few containers for an entire day's operating schedule. It wasn't until the early 1930s when reusable filters were introduced, replacing existing valves and sliding vents. Rubber gaskets were added shortly thereafter to ensure a more effective seal between the lid and container bottom. In the 1960s anodized aluminum containers were introduced. As technology advanced, disposable non-woven filters replaced textile filters as a more secure barrier. In the late 1970’s, rigid containers finally came on the scene in the US. There are presently metal and plastic reusable rigid sterilization containers available for most sterilization systems. Over the last 15 years, they have become very popular because of their cost effectiveness; they can prevent damage to instruments, provide a barrier to contamination, and conserve storage space by having the capability of being stacked. The selection of a rigid container system requires thorough evaluation and consideration to assess the benefits, features, and utilization for the facilities specific needs. Continued on Page 3
Pre-Approved In-service Continued
A thorough product evaluation should always be done for any new product being considered and containers systems are no exception. Important considerations should be given to not only the cost of implementation, but also to the time and cost of repairs from normal wear and tear, improper handling, and routine maintenance. Some containers are approved for steam sterilization only, while others are approved for various low temperature sterilization methods, and one is approved for both. Facilities need to perform instrumentation inventory, current set inventories and evaluate their institutions sterilization systems and what their needs will be. A phase in process may be indicated.
Since rigid containers can trap air in the corners and under the lid (away from the filter), unless otherwise directed by the container manufacturer, it is recommended that chemical indicators be placed in 2 opposite corners of the inside basket as opposed to the center of the pack/tray when wrapped in cloth or paper. According to ANSI/AAMI ST79, the maximum weight of sets for rigid containers is determined by the container manufacturer. Usually this weight is for the instruments and the inside basket. Each set should be assembled so that the instruments are evenly distributed and heavier instruments are placed on the bottom while lighter, more delicate items are on top.
Rigid containers are considered Class II medical devices and must be cleared by the FDA for their intended use. Health care personnel bear the ultimate responsibility for ensuring the container is compatible with or can be effectively sterilized within their health care facility. Since manufacturers cannot possibly test all combinations of sterilizer sizes, cycles, and instrument configuration, health care personnel need to perform testing with their specific sterilization equipment and devices. For more information about the testing process and documentation needed refer to the ANSI/ AAMI document ST77:2006, Containment devices for reusable medical device sterilization.
The container must be placed flat on the sterilizer cart, this will assist with air evacuation, adequate sterilant penetration, drainage of moisture, and efficient drying. If processing a mixed load with wrapped items, the rigid containers should be placed beneath the wrapped sets to avoid moisture in the load. To reduce the potential for condensate to form within the container system, a gradual cool down is required. The door of the sterilizer may be cracked after processing and the loaded cart placed in an area away from direct air flow until completely cooled. Proper storage of rigid containers follows the same guidance as storage for any other type of sterile packaged item.
When performing verification testing, BI’s must be placed within the container in areas that will provide the greatest challenge such as the opposing corners of the instrument basket and the underside of the lid away from the filter. Verification testing must also be documented. Any time the configuration of the set changes, the verification testing must be redone.
In conclusion, rigid containers provide an excellent barrier to microorganisms, ease of use, and instrument protection and organization as long as they are utilized per manufactures recommendations.
Some containers require disposable filters while others have a filter-less system with a pressure sensitive valve that opens and closes within the sterilizer, but every system should include some type of tamper proof locking mechanism. Careful attention must be given to the manufacturer’s written instructions for use to ensure all steps are followed. After each use, the container must be cleaned. Anodized aluminum containers and some polymer containers require neutral pH detergent for cleaning. This is important if you are going to process your containers in cart washers, you will have to switch your detergent. Cart washers use high alkaline detergents which can corrode your containers. How you load the container in the washer will impact cleaning. All parts should be separated so the detergent and water can make contact with all surfaces, and positioned so that water drains. After cleaning, inspect the container for any dents or chips in the lid or gaskets and make sure the filter retention mechanisms fit tightly against the filter. If any of these fail, the container should be removed from service for repair. Remember, the configuration of instruments inside the container can also affect drying. You should not use absorbent materials (e.g. towels) inside the container unless the container manufacturer has tested their use, this is also true for silicone mats. Peel packs should not be used inside containers because they cannot be kept on their side and the container manufacturer did not test for use with peel packs inside. Make sure the manufacturer has approved any special baskets or trays and obtain written verification from the container manufacturer that the container was tested for use with complex devices, lumened items and power equipment if this is what will be sterilized in the container. Be sure to use the security lock system recommended by the manufacturer and if a container is found to be missing a lock, the instruments must not be used without reprocessing. The manufacturer should also provide written verification of shelf life studies. Winter 2013
Continued on Page 4
Upcoming Certification Exam Windows in 2013 Exam Window 1 FEB 4-9, 2013 ——– Exam Window 2 MAY 6-11, 2013 Application Deadline APRIL 30, 2013 ——– Exam Window 3 AUG 5-10, 2013 Application Deadline JULY 30, 2013 ——– Exam Window 4 NOV 4-9, 2013 Application Deadline OCT 29, 2013
***Keys to In-service Quiz 1-C, 2-A, 3-A, 4-B, 5-A, 6-A, 7-B, 8-B, 9-B, 10-A
Pre-Approved In-service Continued
Post Test Rigid Container Systems (From then to Now) This pre-approved in-service is worth 1 CEU with a passing score of 70. Your manager must generate a certificate or letter of completion on facility letterhead with your name, your manager’s signature, test date, test title, and name of journal (Criterion). Please keep this with your re-certification records until it’s time to recertify. 1.
Rigid container systems were first introduced in the US in
A. B. C.
1890’s 1930’s 1970’s
9. The manufacturer is not required to provide written verification of shelf life studies. A. B.
10. To reduce the potential for condensate to form within the container system, a gradual cool down is recommended. A. B.
References The Basics of Sterile Processing Fourth Edition, 2012 ANSI/AAMI ST79:2012
2. Rigid containers are cost effective, provide an effective barrier to contamination, and conserve space.
AORN Perioperative Standards and Recommended Practices, 2010 Edition
3. When considering the purchase of rigid container systems, careful consideration should be given to features, and utilization for the facilities specific needs. A. B.
Rigid containers are considered Class I medical devices.
5. Health care personnel bear the ultimate responsibility for ensuring the container is compatible with or can be effectively sterilized within the health care facility. A. B.
Important Web Links! For important CBSPD announcements, go to www.sterileprocessing.org/info.htm If you are looking for a CS/SPD job or need to post a job opening, go to www.sterileprocessing.org/jobs/page1.htm For CEU/Re-certification info, go to www.sterileprocessing.org/ceu1.htm
6. When performing rigid container verification testing, BI’s must be placed within the container in areas that will provide the greatest challenge.
To download anything from our site, including exam applications, re-cert packets and more, go to www.sterileprocessing.org/download.htm
Looking for CEU programs? Have a CEU program in your area that you want others to know about? Go to www.sterileprocessing.org/future_programs.htm
7. The manufacturer’s instructions for use for filters and valves is not essential information. A. B.
Neutral pH Enzyme detergents can corrode rigid containers.
Looking for CS/SPD training courses? Have a course you want to suggest to us? Go to www.sterileprocessing.org/courses/courses1.htm Managers! Tired of making all those certificates showing your employees passed magazine journal quizzes? How about having a table right on your computer for compiling all your CEU’s? We have what is called an “Ongoing CEU Record”. You can download a copy at www.sterileprocessing.org/ceu_record.htm
Sterile Processing University, LLC... NEED CONTINUING EDUCATION POINTS? NEED TO GET UPDATED IN STERILE PROCESSING? DO YOU WANT TO BECOME A STERILE PROCESSING OR AMBULATORY SURGERY TECHNICIAN, OR FLEXIBLE ENDOSCOPE REPROCESSOR BUT DO NOT HAVE A COURSE NEARBY? YOU DO NOT HAVE TIME TO ATTEND SCHOOL? Understand that certification for CS/SPD personnel is quickly being required throughout the US. Don’t wait until it is required. Get your education now! If already certified, maintain your certification with continuing education. All SPU In-services have been preapproved for CBSPD Continuing Education credits. SPU only contracts with certified sterile processing managers who have a minimum of 15 years’ experience in the profession. In addition, all educational materials are based on scientific data, recommended practices, regulations, etc. SPU educational materials are evidence-based ad updated continually so you get the most current information. Here are the resources we have to help you: FOR STERILE PROCESSING PERSONNEL IN HEALTHCARE FACILITIES – TEXTBOOKS, WORKBOOKS and on-line courses: The Basics of Sterile Processing Textbook and Workbook (4 th edition, 2012). This book was completely updated with new chapters and more photos. The on-line Basics of Sterile Processing course has been completely updated with more information and modules to conform to the expanded FOURTH edition of The Basics of Sterile Processing. For sterile processing personnel working in an Ambulatory Surgery Center, SPU offers an on-line Ambulatory Surgery Sterile Processing Technician course! Coming in April, the on-line Basics of Flexible Endoscopy course! For MANAGERS and SUPERVISORS – SPU offers the textbook, Management Basics for Sterile Processing. The Second Edition (May 2011) was updated with a new chapter on Safety. It includes 17 chapters with all the important management concepts and information to manage and operate a sterile processing department. Indicated for SPD Managers and Supervisors. FOR EDUCATORS – The instructional CD in Power Point for the Basics of Sterile Processing, Fourth edition, has also been updated to facilitate teaching a Central Service/SPD course. The CD follows the course content for the FOURTH edition of The Basics of Sterile Processing. If you previously purchased a CD, you are eligible for an upgrade. Working in GI/ENDO? Purchase your copy of the The Basics of Flexible Endoscope Reprocessing Textbook and Workbook. An on-line course, complete with videos will be available by May 2013. POLICIES, PROCEDURES AND FORMS: - SPU offers policies, procedures and documentation forms on line! Up-to-date and referenced to save you time. Customize to your format. NEW: Certificate Programs: SPU will be offering specialty certificate programs. The first one will be a Certificate in Processing Ophthalmic Instrumentation. This will be available by March 2012. Additional Specialty certificate programs will be added.
Visit: www.SPDCEUS.com for all your sterile processing education needs. SPU……Quality education at affordable prices!
CBSPD, INC. 148 MAIN STREET SUITE C-1 LEBANON, NJ 08833 USA
ALL of 2012 CBSPD Certification Exam Stats (Passing names listed at www.sterileprocessing.org/new_members.htm) Technician: Total Sat for Exam = 3,188; Total Passed = 2,342 (73%); Total Failed = 846 (27%) Manager: Total Sat for Exam = 41; Total Passed = 15 (37%); Total Failed = 26 (63%) Management: Total Sat for Exam = 47; Total Passed = 38 (81%); Total Failed = 9 (19%) Supervisor: Total Sat for Exam = 52; Total Passed = 34 (65%); Total Failed = 18 (35%) Instrument Specialist: Total Sat for Exam = 45; Total Passed = 29 (64%); Total Failed = 16 (36%) Ambulatory Surgery: Total Sat for Exam = 60; Total Passed = 46 (77%); Total Failed = 14 (23%) GI Scope: Total Sat for Exam = 185; Total Passed = 127 (69%); Total Failed = 58 (31%)
PRSRT STD US Postage PAID Permit # 766 Rahway, NJ
**Reminder to All Upcoming April/May 2013 Re-certs** Why retake the exam when after working full time for 5 years, you only need 10 points of education per year to recertify (except for Supervisors/Managers)? If you became certified or re-certified in April 2008, you are due for re-certification in April 2013. Please have your completed re-certification packet with payment into the CBSPD office no later than 3/14/13. If you became certified or re-certified in May 2008, you are due for re-certification in May 2013. Please have your completed re-certification packet with payment into the CBSPD office no later than 4/17/13. The CBSPD mails out re-certification packets 6 months before you are due to expire. If you have not received your packet yet, please contact our office to update your address and/or print one out from our downloads page at www.sterileprocessing.org/download.htm