CMS Infection Control Changes; Up-dates from Excellentia Advisory Group
Important News Updates to CMS Infection Control Audits July 6, 2010

in this issue

From the Desk of Robert Morgan, MSN

Multi-Dose Vials

STERIS UP-Date & Certificate of Medical Necessity

Medication Notes

QAPI Studies Must be Linked to Infection Control Program

Alcohol-Based Hand Sanitizers


 

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

Ambulatory Surgery Centers Safety Lapses A recent ABC news article raised the question, "How Sanitary Are Outpatient Surgical Centers?" Well, the answer sure surprised me! From glucose monitoring equipment, to basic reprocessing procedures, reuse of single dose medication vials and lapses in Infection Control all came under fire. The CDC sampled outpatient surgical center and found some amazing results from their surveys. There are more than 5000 ambulatory surgery centers performing more the six million outpatient procedures. Yet, 67.6 percent of the centers surveyed according to the CDC have had at least one lapse in their Infection Control processes. Additionally, over a quarter, (28.4%) of the centers had problems with the disinfection and the sterilization of their instruments. Blood sugar testing equipment was inappropriately cleaned and the high and lows not monitored properly. Shockingly, at least 28% of the centers sampled were using single dose medication vials on multiple patients.
Where are CMS surveyors looking?
The results of the first round of Ambulatory Surgery Center surveyed by CMS are in! Like CDC's random survey the findings may shock you. Just so you know this also surprised me! Hand hygiene, injection and medication safety issues, environmental cleaning and mishandling of the glucometer were areas most frequently cited by CMS.
There were 19% errors in hand hygiene alone. Most hand washing/sanitizing falls short of the expectation. The surveyors want to see hands washed or an alcohol based hand sanitizer used with each and every patient contact whether it is casual or not. Hands should be washed or sanitized before obtaining supplies and /or equipment, before dosing and passing medication, if you answer the phone, touch your face, use a computer keyboard or any exogenous surface.
Unsafe injection and medication issues occurred in 28% of the facilities surveyed by CMS. Safety issues included misuse of multidose medication vials including beyond the 28 use date, reuse of single dose single patient medications including IV fluid, reuse of syringes and needles on more than one patient and not cleaning or disinfection the injection port. In addition medication was left unattended with access by unauthorized persons which has lead to theft, misuse, and the potential for cross contamination.
In 46% of centers surveyed by CMS, mishandling of their glucometer occurred. Some were using meters that were intended for single patient use. Some centers were not performing monitoring controls of their glucometer. OSHA requires a safety lancet device for puncturing the skin. Manually puncturing the skin is no longer acceptable.
Lately, there was a 19% lapse in environmental cleaning according to CMS. Centers were not cleaning properly between patients with an approved EPA germicide. They were either not cleaning equipment or did not follow the instruction on the EPA approved product they were using.




Greetings ASC Administrator or Directors!

Healthcare workers have a primary responsibility in preventing and controlling infections, especially those workers who have direct contact with patients in the operating rooms, the pre and post operative care units and overnight recovery units of an Ambulatory Surgery Center. As healthcare workers we must be knowledgeable about diseases and disease processes as it relates to infection control, signs and symptoms of infections, risk factor as well as preventive methods. Specifically healthcare workers have the responsibility to:

  • Use proper hand hygiene before and after patient contact by using good hand washing technique or the use of Alcohol Based Hand Sanitizers.
  • Use of barrier protection and precautions including personal protective equipment like face/eye shields, gloves both sterile and non-sterile, gowns/aprons and masks/respirators as necessary.
  • Use good aseptic technique for the placement of invasive devices like intravascular catheters/central lines, urinary catheters and phlebotomy devices.

Finger Nails and Nail care
The finger nails, particularly the subungual area can harbor high levels of bacteria including Staphylococcus, Corynebacteria, Pseudomonas species and yeast. It doesn't really matter if the nails are long or artificial because both have been implicated in the transmission of infections from health care workers to patients. It is recommended by the Centers for Disease Control (CDC) that health care workers who handle patients, sterile supplies, medication, food and equipment keep their nails trimmed to ¼ inch length, wear no artificial nails or nail tips. Nail polish on the other hand if freshly applied and not chipped has not shown an increase in bacterial counts but chipped nails can conceal bacteria as well as sequins, rhinestones or other nail applications. In addition to tranferring bacteria, long nails, artificial nails and nail tips pose further risks such as scratching patients and staff, puncturing gloves or delicate equipment and interfering with palpation of pulses.


  • Multi-Dose Vials
  • What is the recommended time frame that a multidose medication vial can be used once opened?
    According to Section II of the CMS Surveyor Tool for Ambulatory Surgical Centers under Injection Practices it indicates multidose vial are to be disposed of within 28 days. CMS is expecting a 28-day window and citing centers who are not compliant. APIC has a position paper on multidose vial safety titled, Safe Injection, Infusion and Medication Vial Practices in Healthcare. The US Pharmacopeia (USP 2008), A General Chapter 797 Pharmaceutical Compounding - Sterile Preparations, which requires "medication multidose vials for injections be given a beyond-use date that is 28 days after the initial stopper penetration unless the product labeling (package insert) states otherwise."
    The CDC, however, says multidose vials can be used until the manufacturer's expiration date, unless there are any concerns regarding the sterility of the product. I do not know what works for your facility but APIC recommends each facility develop written policies based on one of these recommendations, with the warning that they are consistently followed. Just remember CMS will follow the 28 day rule.
    USP addresses time limits for spiking IV bags as well which fall under medications. USP 797 calls for healthcare facilities to begin administration of spiked IV and compounded sterile preparations when the IV bag is entered by the tubing spike within 60 minutes. If administration has not begun within that hour of spiking the bag, the IV and the tubing should be discarded. APIC takes a different approach and identifies this as controversial and an unresolved issue. There is limited data available on the actual contamination in real practice and linking contamination of IV spiking to patient infections. APIC suggests that a definitive time frame is not feasible and therefore recommends preparing IV bags "as close to the time of administration, as possible". However, APIC does not support advance preparation of immediate-use IV bags (i.e. first thing in the morning for all day or the night before, or hours before administration).

  • STERIS UP-Date & Certificate of Medical Necessity
  • From STERIS Corporation: The latest Information on your System 1 Steris machines and Sterilant. IMPORTANT: Instructions for Properly Completing Certificate of Medical Necessity

    Click for Steris Certificate of Medical Necessity
  • Medication Notes
  • Recently, an Epinephrine shortage of prefilled syringes may cause serious medication errors, and there has already been 1 death reported from an overdose of epinephrine. According to a National Alert issued June 16 by the American Society of Health-System Pharmacists and the Institute for Safe Medication Practices "Medication Errors" may occur. Fatal events can occur when epinephrine 1:1000 (1 mg/mL) ampules and vials and 1:10,000 (0.1 mg/mL) strengths are confused by healthcare professionals. This contains enough volume of drug to allow a 10-fold overdose and the 30-mL vial may easily lead to an accidental overdose. The 30 mL vials can also be confused with other drugs that appear to look the same such as one of the steroid 30 ml vials.
    Precautions to take:

    • EPINEPHRINE: should be spelled with some Tall Man Letters to help prevent medication errors that may be caused by look-alike drug.
    • Healthcare workers should assess all areas where Epinephrine emergency syringes potentially may be used, they should educate clinicians regarding the shortage and recommend possible substitution of products.
    • Current supplies of Epinephrine emergency syringes should be conserved for code boxes. Healthcare facilities should consider whether 2 prefilled epinephrine syringes per crash cart is adequate.
    • Multiple-dose 30-mL vials of injectable Epinephrine 1 mg/mL should not be stocked in code boxes or code carts because they closely resemble other 30-mL vials like topical Epinephrine, which may also be stocked in code boxes or used in the operating room.
    • Epinephrine used for Intra-cardiac should have auxiliary labels warning against intravenous or endotracheal use alerting practitioners to the danger of injury when attempting to removal of the fixed needle. These syringes should also clearly be labeled "For Intra-cardiac Use Only."
    • When 1 mg/1 mL ampules or vials are used instead of emergency syringes, the vial, diluent, and syringe label should be packaged in a clear plastic bags prominently labeled with the drug name and strength. Instructions should be included for preparing a dilution equivalent to a prefilled syringe of 1 mg/10 mL emergency syringe (ie, Epinephrine 1 mg - dilute in 9 mL of sodium chloride 0.9%).
    • When ampules or vials labeled as 1:1000 are substituted, a chart for converting doses in milligrams to milliliters should be provided, include instructions for preparing and diluting epinephrine on or in the code carts. Post these charts in areas where Epinephrine is used.

  • QAPI Studies Must be Linked to Infection Control Program
  • Nurse holding clipboard re QAPI

    CMS mandated that QAPI studies must be done per the May 18, 2009 Conditions of Coverage Changes and they must be linked to your center's infection control program. Current survey feedback is indicating failure to link these two programs and is resulting in citations.
    If you feel that you need more information to structure your QAPI program, click the Learn More link.

    Learn More About our QAPI Webinar
  • Alcohol-Based Hand Sanitizers
  • I receive many questions about Alcohol Based Hand Sanitizers specifically table top pump bottles. If your alcohol hand rubs are in bottles in various areas throughout the center they are considered mobile bottles and are not installed. You may ask, "Do the Life Safety Codes requirements 42 CFR 416.44 (b)(5) apply?
    When ABHS are installed, they have to be at least four feet apart and there are limits on how much alcohol rub you can have within a fire compartment and the number of square feet of your center. Usually you can have 0.3 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors; 0.5 gallons (2.0 liters) for dispensers in suites of rooms. I recommend that you NOT have the 2 liter bottles around. There are too many opportunities for them to end up in the wrong area. Of course if they aren't installed, there is the potential to go over the amount that you are allowed to have within a fire compartment or in the facility according to the square footage of your center. Check with your safety officer or local fire marshal; also review the NFPA Life Safety Codes. Some states may have different guidelines. One of the first requirements from CMS is that dispensers adhere to any applicable local and state requirements and the local fire marshal should be able to guide you on that.

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