CMS Infection Control Changes; Up-dates from Excellentia Advisory Group
Important News Updates RE: CMS Infection Control Audits December 14, 2009

in this issue

From the Desk of Lisa Thomas, BSN

Flashing -Short Cycle Containers

Other Things to Think About?

NPSG.07.05.01

AAAHC 2010 Standards

Inservice Dates 12/17, 1/7, 1/12, 1/20 and 1/27/2010


 

From the Desk of Lisa Thomas, BSN

Happy Holidays to All! Certainly, recent months have seen a flurry of activity surrounding "Infection Control". As if the ASC industry isn't reeling from the changes subsequent to CMS's 416.51 Conditions of Coverage/Standards for Infection Control effective May 18th, 2009 the FDA's announcement last week regarding the SS1 processors is just 'one more thing' to be concerned about! If you are an AORN or APIC member you've seen the email blasts for the FDA's news and Steris' response. "Facilities using the SS1 should transition to an alternative method as soon as possible", says the FDA. Be sure to include your Infection Control consultant/designee in your 'plan' and include your 'alternative method', staff education, etc in your Infection Control meeting minutes, ensuring it gets back to your Governing Board! The FDA Notice is as follows: Steris System 1 Processor: FDA Notice and Recommendations -Announcement Dec 3, 2009 Audience: Hospital risk managers, surgical service managers, infection control professionals FDA notified healthcare facility administrators and infection control healthcare professionals of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices. STERIS has significantly modified the SS1 and FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices. Use of a device that is promoted to sterilize or disinfect a medical or surgical device, but that does not properly perform these functions, poses risks to patients and users. Improperly disinfected or sterilized instruments may transmit pathogens to patients and healthcare staff, or expose them to hazardous chemicals. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments. FDA has received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections. There have also been reports of injuries, mostly burns from exposure to the sterilant solution, to healthcare facility staff operating the device. FDA recommends that if a facility has an acceptable alternative to the SS1 to meet sterilization and disinfection needs, the facility should transition to that alternative as soon as possible to ensure continued patient safety. If an acceptable alternative to the SS1 is not available, the facility should promptly assess its patient-care needs and sterilization and disinfection requirements and take steps to obtain legally- marketed substitutes for the SS1. User facilities, including hospitals, are required to report suspected device-related deaths to FDA and the manufacturer, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown (see http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/PostmarketRequireme nts/ ReportingAdverseEvents/default.htm). Also, FDA solicits voluntary reports of adverse events from healthcare professionals. Adverse events may be submitted online.

Read the complete MedWatch 2009 Safety summary, including a link to the FDA letter to healthcare facilities, at:


Greetings!

If you have been attending our Infection Control webinars, you will find this newsletter issue an important addendum to the information that you have already received from us regarding CMS Infection Control Changes and upcoming audits.
If you have not yet registered for one of our webinars, I encourage you to check us out and register today. This will be the perfect opportunity to ask questions of our Infection Control consultant that you may not be able to get answered easily from other sources.


  • Flashing -Short Cycle Containers
  • Amsco_by_Steris

    Many organizations have found Amsco Sterilization Containers from Steris to meet the 'short cycle' requirement needs. They are approved for terminal sterilization and flash sterilization as well. There are special instructions that come with them for use in flash sterilization, so keep the instructions on site for surveyors! They come in a variety of sizes. The price vary - (9"x14", 11"x16", 11"x19", 12"x12", or 12"23") - $500 - $600 depending on any contracts you may have with Steris.

    Special Patient Safety Alert
  • Other Things to Think About?
    • Are you using disposable water bottles for endoscopy? How are you " high level disinfecting/sterilizing" the water bottle lids/connectors?
    • Are you following the manufacturer guidelines for "Minimal Effective Concentrate" testing? Do you have the documentation/logs to validate this?
    • Does your ASC log the 'loaner scopes' in a log book?
    • Does your processing room sink have a magic marker 'line' to denote the 'fill line' in order to ensure the correct level of water is added to the 'cleaning product' you are using? Based on the manufacturer guidelines of course!
    • Did you know that the National Institute for Occupational Safety and Health (NIOSH) is considering a revision to its gluteraldehyde recommended exposure limit? While OSHA does not have an exposure limit, about 10 states do have permissible exposure limits. For example, California in 2006 reduced it's permissible exposure limit from 0.2 parts per million (ppm) to 0.05. Check with YOUR state's requirements and stay tuned for NIOSH's revisions!
    • Is your ASC planning a construction project? Including painting, wall covering, or other activities which do not generate dust or require cutting of walls or access to ceilings? Are you planning to install additional telephone or computer cables where dust migration might occur?
    • How about the sanding of walls as prep for painting, or any activity that cannot be completed within a single workshift? Be sure to complete an Infection Control Risk Assessment by collaborating with your infection control consultant/designee! Remember that certain precautions must be taken during the construction project and then upon completion of the project!

  • NPSG.07.05.01
  • Many questions have been asked about patient follow- up, antibiotic efficacy and timing, and hair removal. Visit www.jcaho.org for the complete NPSG.07.05.01

    Read on for exert...
  • AAAHC 2010 Standards
  • Recent comments by a AAAHC surveyor indicate the 2010 AAAHC standards will include Chapter 7 as dedicated to "Infection Control". Expect to see AAAHC post their 2010 standards sometime as early as late February or March! You can expect Excellentia to be one of the first to have them and to inform you of the availability. However, check AAAHC regularly in 2010.

    AAAHC website
  • Inservice Dates 12/17, 1/7, 1/12, 1/20 and 1/27/2010
  • If you haven't already attended one of our "Infection Control Changes for ASC's" webinars, we have several more dates to pick from in the next 30 days. Our webinars give you a wealth of information as well as the opportunity to ask questions of our expert. Each participant will receive a Certificate of Completion.

    Click to Register...
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