CMS Infection Control Changes; Up-dates from Excellentia Advisory Group
Important News Updates to CMS Infection Control Audits May 4, 2010

in this issue

From the Desk of Robert Morgan, MSN

STERIS

CMS Revises IC Survey Form

WARNING : DANGER


 

From the Desk of Robert Morgan, MSN
Robert Morgan in conf room

Nosocomial infections represent the fourth leading cause of death in the United States with more than 90,000 incidents among 2 million patients with an annual cost of over $6 billion dollars, ($3000 per patient). With that said, it is estimated, with the initiation of an Infection Control Program using a quality assessment approach that the mortality and morbidity rate could be brought down significantly with very little cost.
As the Infection Preventionist Director, I have had the opportunity to visit many Ambulatory Surgery Centers. The one practice I would like to discuss at this time is the use of a bag of IV fluids, like Normal Saline to draw up flushes for saline locks. This practice is dangerous and could lead to a systemic infection. Acinetobacter baumannii is frequently found in the health care environment, and commonly colonizes irrigation solutions and intravenous solutions. It has been an organism inherently resistant to multiple antibiotics and therefore places your patients at greater risk. As the Infection Preventionist Director I encourage all of you not to use this practice. In the long run it does not save money. A bag of Normal Saline costs about $0.77 while a 10 ml bottle of saline for injection costs about $.037. This would increase your cost for pharmaceuticals by about $174.80 per year while reducing your risk of causing an infection. Which would you rather do?

  • Medical Device Tracking
  • The medical device tracking regulation is published in Title 21 Code of Federal Regulations (CFR) Part 821. This regulation was design to follow implantable devices as it is related to recalls of these devices not for infections. Because of that and the requirements spelled out by Joint Commission's National Patient Safety Goals and the Centers for Medicare and Medicaid on implant tracking has led many to be concern on which ones to track. Although Joint Commission says to track all implants the FDA says something entirely different. Here's a list of items the FDA says we, as healthcare providers, do not have to track anymore. These devices that were subject to tracking orders issued by the agency in February 1998 have received subsequent orders releasing them from mandatory tracking requirements for recalls:
    • Intraocular Lenses
    • Vascular graft prosthesis of less than 6 millimeters
    • Vascular graft prosthesis of 6 millimeters and greater
    • Interarticular disc prosthesis (interpositional implant)
    • Annuloplasty ring
    • Tracheal prosthesis
    • Arterial stents (used in coronary or peripheral arteries)
    • Penile inflatable implant
    • Silicone inflatable breast prosthesis
    • Testicular prosthesis, silicone gel-filled
    • Silicone gel-filled chin prosthesis
    • Silicone gel-filled angel chik reflux valve
    • Infusion pumps
    • Electromechanical infusion pumps
    • Dura mater
    The FDA feels these items do not need to be track for recalls any longer. However, and this really depending on your surveyor, on whether you are Joint Commission accredited or AAAHC accredited, whether or not you must follow all implants for 12 months for infection follow up.

    Click for FDA Device Tracking Guidance


    Greetings ASC Administrator or Directors!

    Did you know that 68% of ASC's surveyed for Infection Control have citations of some type? This trend appears to continue, even after much discussion. Cleaning in general represents the majority of citations- equipment. environment, and hands. A word to the wise, make sure your staff and providers are aware of this trend. Although surveys have now been going on for a full year, the dedication of time and to resources towards the onsite activities does not appear to be diminishing.


  • STERIS
  • The STERIS Corporation has announced it has reached an agreement with the FDA regarding the System 1 sterilization system. It includes an agreement for the transition and rebate program to current System 1 customers in the United States and the decree is still subject to the approval of the U.S. District Court in the Northern District of Ohio. This agreement, in general, resolves the complaint of the FDA allegations from May of 2008 which prohibited the sale of any liquid chemical sterilization or disinfection products specially the ones that do not have FDA clearance. This will formalize STERIS'S rebate program and allow the continued support of customers with System 1 equipment. STERIS, under the transition plan, will be offering a rebate program. U.S. customers who have purchased System 1 processors from STERIS have the option to have a pro- rated cash rebate or can trade-in there equipment towards purchase of new capital equipment and/or consumable products. There is a condition to participation in this program, The System 1 units must be returned.

    • What kind of training does House Keeping need to have?
    • If we want to do "Home Laundry" who endorses that?
    • If our ET tubes have an expiration date on them are they not any good if the expiration date has passed?
    • Where can my Alcohol Hand Sanitizer Dispensers go?
    • We would like to store sterile items on wire racks with clean items. Where is it appropriate to store sterile items?

    Click for Steris News Release...
  • CMS Revises IC Survey Form
  • CMS Modifies Surveyor Worksheet March of this year CMS revised the ASC Infection Control Surveyor Worksheet. This new format will be used by all surveyors effective 4/12/10. While there are no changes to content, the purpose of this is to make the overall process more efficient. Surveyors are being instructed to submit their reports within 10 working days of your review. While you likely will see multiple surveyors at your location completing individual forms, they have been instructed to consolidate the information and submit only one completed form to CMS. Click for Revised IC Worksheet Policy Announcement

    Click for Revised IC Worksheet
  • WARNING : DANGER
  • There is a fungus among us! A new Deadly Airborne Fungus has been identified in Oregon. According to scientists from Duke University Medical Center, the fungus, which has caused several deaths in Oregon, will soon move into the adjoining states like California, Idaho and Nevada. Originally, this fungus outbreak was seen in Canada in 1999 but has spread into Washington state and Oregon.
    Typically this fungus, Cryptococcus gattii, is seen in patient with HIV-infections or transplant recipients but this is not the case in Oregon. This virus is troublesome threatening healthy people with a mortality rate of approximately 25 percent in the United States and an 8.7 percent in Canada and British Columbia. The course of the disease is more complicated with the C. gattii than with the more common fungus of Cryptococcus neoformans.
    Beware of this strain! It is very virulent especially when it infects humans it also affects animals. Symptoms of C. gattii can be delayed from two the several months after the initial exposure. These include a cough which could last for weeks, SHARP chest pain, Shortness of breath, a headache which is similar to a meningitis headache, fever, nocturnal sweats, and weight loss. Animals may have a runny nose, trouble breathing, nervous system problems and raised bumps under the animal's skin.

    Read on...
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