IUSS - Follow the standards…… or get cited!

1 1 March 19, 2015 IUSS - Follow the or get cited! Today s meeting times: 9:00 , 11:00 , and 1:00 Central Standard Time To hear audio, call 800-937-0042 and enter access code 7333633 Phone lines are muted. Audio will commence when the webinar !Topic: IUSS - Follow the standards or get cited! Facilitators: Christophe de Campeau, 3M Susan Flynn, 3 MSpeaker: Rose Seavey MBA, BS, RN, CNOR, CRCST, CSPDTH ousekeeping Questions Mute feature (*7 = unmute; *6 = mute) Chat feature Technical difficulties Post session Follow -upFor more information: 3M 2015. All rights reserved. How do I get a CE Certificate?

2 Next week, all of today s meeting participants will be sent an email containing instructions for obtaining a CE Certificate for today s meeting. The email will be sent to the email address you provided when you logged-in to today s meeting. If there are others listening with you today who did not log-on, you may forward the CE certificate email to them. 3M 2015. All rights reserved. 2 Disclosure StatementRose Seavey MBA, BS, RN, CNOR, CRCST, CSPDTE ducational Consultant to 3M Health Care 3M 2015. All rights reserved. Learning ObjectivesExplain CMS s Update - Survey and Certification Memorandum Regarding IUSS Identify The Joint Commission s standards related to IUSSR eview the most current AORN and AAMI standards and guidelines relating to IUSS 3M 2015.

3 All rights reserved. Learning Objective 1 Explain CMS s Update of Survey and Certification Memorandum Regarding IUSS 3 August 29, 2014, 9 Page MemoTO: State Survey Agency DirectorsFROM: Director Survey and Certification Group Change in terminology and update of survey and certification (S&C) memorandum 09-55 regarding immediate use steam sterilization (IUSS) in surgical settings Outmoded Term - fails to communicate time, number of steps and safeguards -accessed 02/24/2015 3M 2015. All rights reserved. Just Flash it!Sterilization cannot be done in a flash!8 3M 2015. All rights reserved.

4 3M 2015. All rights reserved. 4 Immediate Use - Defined Broadly defined The shortest possible time between a sterilized items removal from the sterilizer and its aseptic transfer to the sterile field. Used during the procedures for which it was sterilized Transported in a manner that minimized exposure to air and other environmental contaminates Not stored for later use, nor held for later case10 3M 2015. All rights reserved. Immediate-Use Steam Sterilization Multi Societies agree that: All personnel involved in reprocessing: Be knowledgeable (different types of sterilizers and cycles), Exercise critical thinking and judgment, and Implement standardized practices Supervising organization responsible for ensuring appropriate training, education and competence Sufficient instrument inventories necessary to meet expected surgical volume11 3M 2015.

5 All rights reserved. CMS Change in IUSS Terminology IUSS not an appropriate substitute for maintaining a sufficient inventory of instruments IUSS survey procedure infection control citing Using IUSS in a manner that places patients at risk No to any IUSS survey questions 12 -accessed 2/24/2015 3M 2015. All rights reserved. 5 CMS- Defining IUSS Practice Not equivalent to short cycle Not a substitute for sufficient instrument inventory Not stored for later use Must accomplish all steps before, during and after In compliance with manufacturers IFUs Device Sterilizer Container Cleaning performed in a designated decontam area13 -accessed 2/24/2015 3M 2015.

6 All rights reserved. CMS - Defining IUSS Practice (cont d) Increased risks: Contamination during transfer Related to wet instruments Potential for burns Limited to situations: Urgent need, and Insufficient time for terminal sterilization14 accessed 2/24/2015 3M 2015. All rights reserved. Surveyors Specific IUSS Questions IUSS reserved for immediate use needs (used emergently)? Process in place to ensure IUSS is not used for: Implants, Patients with known or suspected CJD, Loads not validated with the specific cycle, and Single-use devices Instruments first cleaned and disinfected following the manufacturer s IFU?

7 15 3M 2015. All rights reserved. 6 Surveyors IUSS Questions (cont d) Evidence that all of the personnel have: Necessary time, equipment, supplies, Trained and able to correctly Follow the MFR IFU, and Competency initially verified before they undertake IUSS and periodically thereafter? Evidence cycle is indicated in the IFU? Physical monitors documented? Evidence sterilizer is maintained? Rigid container consistent with MFR IFU?16 3M 2015. All rights reserved. Surveyors IUSS Questions (cont d) CI labeled for cycle by the MFR? CI outside each container/package Unless CI inside package is visible Class 4, 5 or 6 CI in each container?

8 BI labeled for cycle by MFR? Implantable device - BI and Class 5 CI labeled? All monitoring test results by trained personnel? Instruments aseptically transported and cooled? Evidence of monitoring for adherence to policy? 17 accessed 2/24/2015 3M 2015. All rights reserved. Short cycle Confusion American Society of Ophthalmic Administrators (ASOA) released a public statement 2/5/15 titled, CMS Clarifies Policy to Permit Use of Short Cycle Steam Sterilization in Ophthalmic ASCs Outpatient Surgery E-Weekly 2/10/15 stated that based on CMS clarification Ophthalmic ASCs can breathe a sigh of relief and that short-cycle steam sterilization, as widely practiced in ambulatory ophthalmic centers, is permissible as long as they Follow manufacturers' directions for use.

9 3M 2015. All rights 7 Sterilization of Ophthalmological Surgical InstrumentsCMS 2/26/2015 Short cycle form of terminalsterilization Wrapped/contained load Pre-cleaning performed according to manufacturer s IFU Load meets device manufacturer's IFU including complete dry time Packaged in a wrap or rigid sterilization container validated for later use19 3M 2015. All rights CMS MLN Connects Provider eNews 2/26/2015 #_Toc412619745 CMS Letter Endnotes Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

10 ANSI/AAMI ST 79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (consolidated text) AORN. Recommended practices for sterilization in the perioperative practice setting. Perioperative standards and Recommended Practices. Denver, CO: AORN, 2014. Centers for Disease Control (CDC). Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. Seavey R. Immediate use steam sterilization: Moving beyond current policy. American Journal of Infection Control. 2013;41:S46-S48. 20 accessed 12/21/2014 3M 2015. All rights reserved. CMS: Deeming Authority Accreditation Association for Ambulatory Healthcare (AAAHC) Accreditation Commission for Healthcare (ACHC) American Association for Accreditation of Ambulatory Surgery Facilities (AAASF) American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFPA) Center for Improvement of Healthcare Quality (CIHQ) - new 8/9/2013 Community Health Accreditation Program (CHAP) DNV Healthcare (DNV) The Joint Commission (TJC)21 Seavey.