CRITERION. What s Inside. A Message from the Executive Director By: Nancy Chobin, R.N., CSPDM

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1 CRITERION JANUARY 2007 The Official Newsletter of the CBSPD, Inc. VOLUME 12, ISSUE 1 A Message from the Executive Director By: Nancy Chobin, R.N., CSPDM Greetings from the CBSPD, Inc. This has been another exciting year with 2007 having more in store! Computer-based testing - The process of computerbased testing was a resounding success! We had few problems and most candidates were excited to take their exams on a computer and get their preliminary results the same day. The CBSPD is grateful to the many individuals who helped with this process, especially the CBSPD Item Review Committee (Chairperson Sue McManus, RN, CSPDM and Co-Chair Karen Swanson, LPN, CSPDM) and the CBSPD office staff. A reminder that starting in 2007, all CBSPD exams administered in the US will be administered during a one-week window in February, May, August and November. New exam - The CBSPD is now pursuing a sixth certification, this one for those personnel who process flexible GI scopes. This is an important processing task which, if done incorrectly, can lead to nosocomial infections. The CBSPD is in the development phase now and hopes to implement this new exam by the end of New Board Members The CBSPD welcomed new Board Members Angela Joyner (Supervisor representative to the Board) from Rush Foundation Hospital, Meridian, MS; Jeanette Walch (Ambulatory Surgery representative to the Board)from Big Sky Surgery Center, Missoula, MT and Jeanette Bakker (Surgical Instrument Processor representative to the Board) from Palos Community Hospital, Palos Hgts., IL. The new Board members were oriented at the Board meeting in September and are excited to be a part of the CBSPD and to represent their credential. Mandatory Certification The clock is ticking in New Jersey where all sterile processing personnel have until August 2009 to become certified. Meanwhile New York is moving closer to this goal. The group working in mandatory certification in NY have met with a legislator who may draft a bill requiring licensure! See what is happening in your state and work with your state Sterile Processing/CS organization to require certification. Pan-American Conference I had the honor of representing the CBSPD at the Fourth Pan American Sterilization Conference in Mexico City in October. Over 1,100 people from Central and South America attended. The 3-day conference was filled with educational programs and scientific papers on sterilization. However, the most interest was generated by my presentation on certification. International Certification The CBSPD is continuing to expand into the international community. Discussions have been held with Australia regarding certification. Costa Rica and San Salvador are also interested in starting certification. Guatemala and Peru started certification in Both countries experienced outstanding grade results. The CBSPD, for the time being, continues to provide paper-pencil exams in countries outside the US. At this time of year, we get together with families and friends to wish Happy Holidays and share gifts of thought. Let us not forget the many men and women who are serving our country all over the world so that we can remain home and enjoy the benefits of living in a free country. Let us also says prayers for the many servicemen and women who gave their ultimate sacrifice, their lives, for our country and the thousands who have been injured in their course of duty. All of these are true American Heroes and deserve our thoughts, prayers and THANKS! On behalf of the CBSPD, best wishes for healthy and prosperous Holidays and a successful New Year! AAMI UPDATE At the November 2006 AAMI meeting (Association for the Advancement of Medical Instrumentation), many accomplishments were made. The new ST-79 (Comprehensive Guide to Steam Sterilization and Sterility Assurance for Health Care Facilities) has been published and is selling like hot cakes! It has become AAMI s best seller in history. Every SPD/CS Department MUST have a copy.this should be your Bible (it is also a national standard so this is the minimum you should be doing). This document combines 5 previous documents including Decontamination, Steam Sterilization, Rigid Containers, Ambulatory Care Sterilization, Flash Sterilization and the original ST-46 document. Some of the major changes in this document include: Whenever an implant is sterilized, the PCD (process challenge device formerly called BI test pack) must contain a class V chemical integrator inside the test pack. In the event of a need to release the implant before the result of the BI is known, the class V integrator provides additional information about the cycle. When a new sterilizer is installed, re-located or after major repair, the sterilizer must be re-commissioned or re-tested. The revised procedure is: Three PCD (BI test pack) tests, performed in an empty sterilizer, for three consecutive cycles. If gravity displacement cycles are available, the gravity cycle must also be BI tested) Continued What s Inside AAMI Update: Front Cover 2007 Exam Dates: Pg. 3 Continuing Education Report: Pg. 3 Pre-Approved In-service: Pg. 5 In-service Corrections: Back Page

2 Nancy Chobin s Column Continued Followed by 3 Dynamic Air Removal (formerly called Bowie-Dick) tests. This procedure is the opposite of what is done daily, but performing the PCD testing first creates a greater challenge for the sterilizer. AAMI has priced the ST-79 at only $200, which is a great value. In addition, anyone ordering in 2006 will receive free updates (AAMI will provide annual updates and Annexes) for the next 3 years. Contact for more info. The new ST-77 (Rigid Container and Organizing Cases) document was just approved as a national standard. This document covers all the requirements for rigid containers, how they are made, the sterilization cycles, etc. However, this document also covers organizing cases (e.g. Orthopedic screws, plates). The document specifies a maximum weight of 25 pounds for the sets including the container. It will take the Orthopedic vendors some time to re-configure their sets to meet this standard. The Ethylene Oxide document is being updated with required PCD testing also being revised. The Water Quality document is moving along. This document will specify the quality of wash and rinse water for devices based up their use. AAMI was asked to consider two new documents; one on TASS (Toxic Anterior Segment Syndrome) and Flexible GI Scopes. TASS is a serious occurrence after cataract surgery. Publications have linked TASS (TASS results when a noninfectious toxic agent enters the anterior segment during surgery and causes an inflammatory reaction) to many causes. However, of concern to CS/SPD is when endotoxins form. Endotoxins are potentially toxic, natural compounds found inside pathogens such as bacteria. Classically, an "endotoxin" is a toxin, that is not secreted in soluble form by live bacteria, but is a structural component in the bacteria which is released mainly when bacteria are killed. (Wikipedia.com). There is a concern about the steam quality and use of tap water to rinse eye instruments. Several TASS outbreaks occurred because tap water was used to rinse off instruments between cases. Some publications pointed a finger at detergent residues so some facilities only rinse their instruments instead of cleaning them. According to an article in Cataract Magazine (October 2002) Tap water contains low levels of standard Gram-negative bacteria. Sitting around for a week at room temperature with some food, it multiplies and produces a heat-stable endotoxin that can withstand autoclaving, one physician said. Incredibly small amounts can cause a toxic reaction. Currently the Food and Drug Administration recommends that all eye instruments be rinsed with sterile distilled water after cleaning and before sterilization. Many facilities use several rinses in sterile distilled water. The article in Cataract magazine further stated: Residue. Several scenarios can cause trouble: If phacoemulsification hand pieces are sterilized with ethylene oxide gas and the gas residue is not completely aerated off the instrument, TASS can result. Residue from viscoelastic or detergents inside a reusable instrument or cannula can cause TASS. Cement sealant on the bags of irrigating solution has leached out and caused TASS. JANUARY 2007 TASS Continued Years ago, IOLs were a common cause, often because of an aluminum hydroxide polishing compound residue. A recent TASS outbreak related to the Memory Lens was probably due to the same thing a polishing compound residue, Dr. Olson said. Both AAMI and AORN are working on this issue. AAMI plans to get instrument manufacturers, detergent manufacturers, sterilizer manufacturers and others together to address this issue and hopefully come to a scientific conclusion. Meanwhile, make sure your eye instruments get well rinsed with sterile distilled water! NEW TEXTBOOK a new book The Basics of Sterile Processing is available for personnel performing cleaning, disinfection and sterilization. The book covers all aspects of Sterile Processing as written by sterile processing professionals with many years of experience and all of whom are certified. The book is available for $70 from the CBSPD or at: There is also a limited number of books with damaged covers (contents all present) which are available for $35 each. CBSPD Board of Directors Executive Commissioners (Non-Voting) Nancy Chobin, R.N., CSPDT, CSIP, CSPDS, CSPDM, CASSPT Executive Director Teckla Ann Maresca, L.P.N., CSPDT, CSIP, CSPDS, CSPDM, CASSPT; Co-Chairperson, CEU Review Committee Sue McManus, R.N., CEH, CSPDT, CSIP, CSPDS, CSPDM, CASSPT; Test Development Committee Liaison Nora Wikander, R.N., CSPDT, CSIP, CSPDS, CSPDM, CASSPT; Co-Chairperson, CEU Review Committee Bobby Osburn, CSPDM, Veteran s Affairs Representative Martha Young, CSPDT, International Liaison Representative M. Eleanor Reilly, R.N., CSPDM, Board Member Emeritus Margaret Ryan, R.N., CSPDM, Board Member Emeritus CBSPD Voting Board Representatives Karen Swanson, L.P.N., CSPDM, Manager Angela Joyner, CSPDS, Supervisor Lanfrey Funches, CSPDT, CSPDS, Technician Jeanette Bakker, CSPDT, CSIP, Surgical Instrument Processor Jeanette Walch, CSPDT, CASSPT, Ambulatory Surgery Tech. Barbara Aldeman, CSPDT, Veteran s Affairs Technician Paul Letersky, B.A., J.D., Public Member 3M/SPS Medical Scholarships The Board of Directors of the CBSPD want to congratulate everyone that was awarded scholarships this past year from both 3M and SPS Medical. A list of all winners is posted on our website on the CS Scholarships page. As of this time, we are still awaiting word from 3M as to whether or not the scholarships will be offered in Please stay tuned to our website or call our office for further information in the coming weeks. SPS Medical will continue to offer their scholarships for all of the CBSPD exams. An application can be obtained on our website or by calling SPS at

3 3 Upcoming Certification Exam Windows And Application Deadlines (within the U.S.) Administration Dates 1 FEBRUARY 19-24, 2007 Application Deadline 1 JANUARY 22, 2007 Administration Dates 2 MAY 7-12, 2007 Application Deadline 2 APRIL 9, 2007 Administration Dates 3 AUGUST 6-11, 2007 Application Deadline 3 JULY 9, 2007 Administration Dates 4 NOVEMBER 5-10, 2007 Application Deadline 4 OCTOBER 8, 2007 Continuing Education (CEU) Column By: Teckla Maresca, L.P.N., CSPDM Nora Wikander, R.N., CSPDM CEU Column Continued Managing Infection Control, PO Box 25310, Scottsdale, AZ, 85255, , Infection Control Today, Virgo Publishing, PO Box Phoenix, AZ , ext. 1285, Materials Management In Healthcare, AHA Publication, ASHCSP membership benefit, , for membership information. There are also multiple websites that have in-services both free and for a minimal charge: Iceinstitue.com; e-cspd.com; Endonurseinstitute.com; ncahcsp.org/newletter.htm (North Carolina Central Association Newsletter); ashcsp.org (American Society Healthcare Central Service Professionals newsletters); spsmedical.com (SPS Medical Supply); spdceus.com (Sterile Processing University). The CBSPD website sterileprocessing.org has a lot of information regarding in-service ideas, a sample CEU form to list your journal in-services instead of individual certificates this option requires your manager, their boss, education department representative or a human resource representative to sign the completed form to verify that you completed the in-services listed. There are also web links that are useful and downloads that include our newsletters and a CEU packet. Sterile Processing manufacturers provide educational opportunities as well. Your local sales representatives present some in your institution, some have CD ROM programs as well as printed In-services. These manufacture s include but are not limited to: 3M Corporation; Honeywell-Oxyfume; SPS Medical; Advanced Sterilization-ASP; ISH, Inc.; Getinge USA; Kimberly Clark Corporation; Medcom, Inc.; Steris; Case Medical; J a r i t Instruments; Total Repair Express (TRE); Eco-Lab; Pfiedler Enterprises; C-Step; Healthmark Industries; and Spectrum Surgical. Get involved with your local Central Service Organizations, you can assist on committees or run for office both of which you can get credits for. They also provide seminars at reasonable prices as well as networking opportunities. It is a good Continued on Page 5 Did you know that you can earn CEU s by submitting questions to our Item Review Committee, preparing and presenting CS/SPD educational programs to groups (other than departmental inservices), having a paper or article on CS/SPD topics published (by a reputable publication), and chairing or serving on committees or holding office in a local, state and/or national level of a CS/SPD related healthcare professional organization? Adult or Continuing education and college courses can also be used for continuing education contact hours. For more information on each of these opportunities you can download a copy of the Continuing Education Protocols from our website or request a copy be sent to you by contacting the office Professional publications are available and should be used to keep you updated on what is happening in the profession as well as giving you opportunities for approved in-services. These publications can be obtained by the following manner: Healthcare Purchasing News (HPN), 7650 So. Tamiami Trail, Suite 10, Sarasota, FL, 34231, ext October 2006 CBSPD Certification Exam Stats (Passing names listed on our website) Technician: Total Sat for Exam = 797; Total Passed = 581 (73%); Total Failed = 216 (27%) Manager: Total Sat for Exam = 25; Total Passed = 1 (4%); Total Failed = 24 (96%) Supervisor: Total Sat for Exam = 20; Total Passed = 11 (55%); Total Failed = 9 (45%) Instrument Processor: Total Sat for Exam = 70; Total Passed = 34 (49%); Total Failed = 36 (51%) Ambulatory Surgery: Total Sat for Exam = 34; Total Passed = 17 (50%); Total Failed = 17 (50%) Key to Quiz: 1:F, 2:F, 3:T, 4:T, 5:F, 6:T, 7:T, 8:F, 9:F, 10:T

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5 CEU Column Continued JANUARY way to get word of mouth job opportunities as well as sharing inservice ideas. National organizations, the ASHCSP (American Society Healthcare Central Service Professionals) and IAHCSMM (International Association Healthcare Central Service Material Management) are a good source to locate chapters near you. Share your knowledge, develop a program and share it with groups of CS/SPD employees in your area. Contact those institutions near you and see if you can get a group together for some education sharing. You can submit the program you develop and the information regarding the group you are presenting to the makeup of the audience, dates and sign in sheets and you may be eligible for additional credits. For those of you having difficulty getting your manager to support your educational efforts you may want to seek someone else in your institution to review your printed in-service tests and ask them to verify your completion of them. Check with the OR Educator, Infection Control Nurse, Material Manager, Human Resources or the Nursing Education Department. Bring the information you received about re-certification or the Continuing Education Protocols to the person you have recruited to help you so they will know what is required. For those of you between jobs you can check with your local CS/SPD association and ask if a board member would assist in this verification. There are many ways to get the points needed for recertification, especially if you start as soon as you get your original certification letter. As you get points, put your certificates or letters of completion in your re-certification folder and mark off on the front of the folder the number of credits you have. This will give you a sense of completion as well as a quick reference of where you are at with re-certification credits. If you obtain at least ten continuing education points per year it won t be so overwhelming five years from now when you need to re-certify. We would like to make a correction regarding the costs as they were published in the last newsletter. The cost breakdown over a five year period: Less than 6 (six) cents per day or $20 (twenty dollars) per year start a re-certification savings jar and put a $1.70 a month in it you will have your re-certification fee at the end of 5 years. We hope that these tips help you in attaining your recertification. PRE-APPROVED IN-SERVICE Chemical Indicators By: Jeanette Bakker, CSPDT, CSIP INTRODUCTION: There are many components included in the process of sterility assurance. The utilization of chemical indicators (CI) is one step we take to provide visual assurance, through a color change, that an item has been exposed to the sterilization process and has met one or more of parameters of that process. Although chemical indicators do not guarantee sterility, when used in conjunction with the other components of sterility assurance they provide important information, especially to the end user. CI s that fail to demonstrate an appropriate color change may be an indicator of sterilizer malfunction, operator errors, faulty indicators, and incorrect packaging. When a CI fails to show an adequate color change it is up to the user to reject the item for use and to investigate why it has failed. There are two types of CI s, internal and external. External indicators are those found on the outside of the packages being CBSPD In-service Continued sterilized such as indicator tapes or labels and show that a package has been in the sterilizer but do not provide any assurance that the package is sterile. Internal indicators are placed in the center, and densest, location of a tray or package in order to present the most difficult challenge to penetration by the sterilant. Depending on the type of indicator used internal indicators will show that one or more of the parameters needed to accomplish sterilization have been met. The user must be trained to correctly place and read the internal indicator. Before any sterilized package is released for use, the external indicator must be checked for a distinct and uniform color change. When the package is opened for use the end user must check the internal indicator for a complete and uniform color change. If either indicator, external or internal, is questionable the item should not be used. Classes of Chemical Indicators: There are five classes of chemical indicators each requiring specific parameters to achieve an acceptable color change. Class 1: Process Indicators: Process indicators are usually found on the outside of packages (wrapped items, peel pouches or containers) and show that the item was exposed to a sterilization process. Each indicator is designed for a specific type of sterilization process. The user will see the color change on the indicator and determine between processed and unprocessed products. Class 1 indicators do not differentiate between sterile and unsterile they only indicate exposure to the sterilant for which it is designed. Class 2: Referred to as the Bowie-Dick Test indicator is, used in the composition of a specific test used to indicate adequate air removal in a pre-vacuum steam sterilizer. The test is also known as the Dynamic Air Removal Test. When performing this test it is important that specific exposure times be adhered too as over exposure may produce a false negative. If the sterilizer has been turned off for 8 hours or more before the test is performed it may fail the test and a second test should be run before removing the sterilzer from service. A failed Bowie Dick indicates that adequate air removal has not been achieved during the conditioning phase of the sterilization cycle. If this condition is not corrected sterilization may not be achieved due to air pockets in the packages. Service must be completed on the sterilizer before it can be put back in use. Class 3: Single-Parameter Indicators: Singleparameter indicators are designed to react to only one of the critical parameters of the chosen sterilization method. In steam, for example, the parameter is usually time or temperature. Single parameter indicators may be internal or external chemical indicators. Class 4: Multi-Parameter Indicators: Class 4 chemical indicators are more precise than class 1 and 3 as they react to two or more critical parameters of the specific sterilization method being utilized. For example, the two parameters of steam sterilization are time and temperature and, in ethylene oxide, time and concentration. Class 5 Integrating Indicators: The most sophisticated and accurate of the chemical indicators they react to all the critical parameters of the specified sterilization process being utilized. The response of the Class 5 integrating indicators have been shown to correlate to the response of the biological test organism for specific types of sterilization processes making them extremely valuable in determining the success, or failure, of the sterilization process. This type of CI can be used as the basis to release loads without implants. When selecting a Class 5 integrator it is imperative that you know the parameters of the cycle and Continued

6 CBSPD In-service Continued process being tested and match them to the correct integrator. What You Need to Know When Selecting a Chemical Indicator: When selecting a chemical indicator for use the following are some of the questions that need to be asked: What parameters will the product react to? Are the parameters the same as the cycles run in your sterilizer? How is the product stored? Consideration must be given to the affect that temperature, exposure to light, and humidity will have on the product. Are there any potentially hazardous substances in or on the indicator? When handling the product, are there any precautions that need to be taken. What are the specific parameters that the indicator will react to and provide a pass result? It is important for the user to understand that not all steam or gas sterilization cycle parameters are the same. Do you need a specific indicator for specific cycles? Once exposed and an acceptable change has been reached, does the color remain the same or does it change? If not, what factors will change it and what will the change be. What is the shelf life of the unused product? Are there any color changes that will occur between complete exposure and partial exposure to the sterilization cycle? Required Information for Packaging: The product package should have the following information: How the product should be stored The specific classification it belongs to The date the product was produced, and when the product will expire. Storage conditions A lot number so the product can be recalled if it becomes necessary. The manufacturer s address. After the CI has been used, how is it stored and if it needs to be saved for some type of record keeping The specific parameters necessary to achieve a pass result. When the Chemical Indicator Fails: Because chemical indicators are visual tools and found on, and in, every package sterilized they may be the first indication of a sterilization failure. A failed or suspicious indicator should never be ignored. Attention should immediately turned towards all of the steps in the sterilization process for the cause of the problem: Check all mechanical sterilization monitoring devices such as print outs and graphs for potential problems or discrepancies in the parameters measured such as time, temperature, pressure, etc. Look at how the sterilizer was loaded. Based on the contents could it have been overloaded? Check the way items are packaged. Are items too large, too dense, and are the packaging materials acceptable? Other things that need to be considered are: Are all of the indicators in the load affected or is the problem being seen on one or two packages. Does it appear that there was excessive moisture in the load? Are the indicators used outdated or expired? If the indicator was in a tray or basin was the tray or basin unusually wet when wrapped? When selecting and using chemical indicators you must first know parameters required to achieve sterilization in your sterilization JANUARY 2007 equipment whether it is steam, ethylene oxide gas, gas plasma, or other chemical sterilizers. Only then will you be able to select a chemical indicator that will meet your needs. In order to use the indicators selected appropriately the SPD Tech and the end user must be educated with regards to placement of the indicator, reading and interpreting the end result, what is being measured and what measures are to be followed if the indicator hasn t passed. Always remember that chemical indicators do not guarantee sterility but are an integral part of the quality assurance process for sterilization. Failed indicators must never be ignored and require follow up. All failed indicators and the ensuing follow up should be documented and filed with the sterilization records. Depending upon the policies in your institution this information should also be reported to the Infection Control Committee and Quality Assurance Department. References: Comprehensive guide to steam sterilization and sterility assurance in health care facilities; AAMI ST79:2006. The Basics of Sterile Processing; Sterile Processing University, LLC; Chapter 8: Sterilization, 1 st Edition POST-TEST Chemical Indicators 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, signature of your manager, date of test, title of test, and name of journal (Criterion). You will keep this with your re-certification records. DO NOT SEND THIS TEST TO THE CBSPD OFFICE. 1. The use of chemical indicators guarantees sterility of processed items. 2. Within the five classes of chemical indicators, one class ranks higher than the next. 3. An example of a class 2 indicator is the Bowie-Dick test. 4. Class 5 integrator indicators provide the most information. 5. Lot numbers are not required for chemical indicators. 6. When a chemical indicator fails one thing to check is how the sterilizer was loaded. 7. When choosing a class 5 integrator it is important to know the parameters of the cycle and process being tested. 8. A failed chemical indicator will identify the reason of the failure. 9. Class 5 chemical integrators can be used in place of a biological test for implants. 10. A failed Bowie-Dick tells the user that not all the air has been removed during the conditioning cycle. 6

7 Back Page **Reminder to All Upcoming April & May 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? If you were originally certified on 4/19/97, 4/19/02 or 4/20/02, you are due for re-certification next April. Please have your completed re-certification packet with payment of $100 into the CBSPD office no later than 4/30/07. If you were originally certified on 5/16/92, you are due for re-certification next May. Please have your completed recertification packet with payment of $100 into the CBSPD office no later than 5/30/07. 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 or print one out from our downloads page at. April 2006 CBSPD Re-Certification Stats (Passing names listed on our website) October 2006 not available at this time but will be posted on the website and in next Criterion. Manager: Total Eligible = 6; Total Re-certified = 1 (17%) Supervisor: Total Eligible = 8; Total Re-certified = 2 (25%) Technician: Total Eligible = 757; Total Re-certified = 248 (33%) IN-SERVICE CORRECTIONS June 2004 Criterion; Pre-approved in-service - "Truth or Consquences; the Processes We Follow" by Barbara Leigh, CSPDS. Question #10 lists choice "E" as the correct answer. The actual correct answer is choices "A and C". Sterile Processing University, LLC... Announcing a new web-location for CEUs. All approved by the CBSPD, Inc. for continuing education credits. CEUs can be done on-line or by mail. Order your copy of the new The Basics of Sterile Processing textbook from our site. This is the most current sterile processing textbook available. Visit: today!