In our prior webinars we have talked about a citation at one facility concerning an open and undated bottle of Acetaminophen. The facility was contesting the citation because this bottle was for their staff and not for patients. The CMS surveyor insisted that it was an infraction because it was a drug and should follow the guidelines for dating the expiration on open medication, (which is 28 days) I recently contacted the FDA and the head of a local pharmacology program concerning oral medication and when they expire.
The FDA's Division of Drug Information communicated to me through an email stating, "If there is no specific information in regards to when the product expires once it is opened, then it is the manufacturer's expiration date listed on the product." The FDA went on to say that this is an informal communication that represents their best judgment at the time and does not bind or obligate the agency to the views expressed in the email. So, I think they just said, "yea, follow the manufacturer's expiration date but don't hold us to that!
I also spoke to the head of a College of Pharmacy who told me that most of the oral medication, if stored in a well controlled temperature and humidity area, "they could last almost forever". However he was not aware of anything that says oral medication that is kept in a controlled environment expires 28 days after opening it.
USP defines an expiration date as "the time during which the medication may be expected to meet the requirements of the pharmacopeia monograph and provided it is kept under the prescribed conditions." USP defines CRT, (Critical Room Temperature), as "a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77 °F) and a relative humidity of 35-60%. The expiration date, which limits the time during which the medication may be dispensed or used, is based on scientifically sound stability studies carried out by the manufacturer and is usually expressed in terms of a month and a year, as stated on the manufacturer's container. This means that the product can be used or dispensed until the last day of the stated month and year. The General Notices defines the beyond-use date for multiple-unit containers as "not later than (a) the expiration date on the manufacturer's container or (b) one year from the date the drug is dispensed, whichever is earlier."
I have received an email explanation from my contact at CMS as follows: " Dear Bob, I wanted to review this question with the CDC before responding, and have now heard back from two CDC experts who agree. Here is their comment: The 28-day beyond-use-date is based on USP standards set for sterile pharmaceuticals (USP NF; Chapter 797: http://www.usp.org/products/797Guidebook/) and is not intended for non-sterile oral pharmaceuticals. Manufacturer's expiration date should be sufficient."

I have had several questions on Ice, Ice machines and Ice Scoops recently. Is using ice at our facility okay? Can we have an ice machine and use it for our patient's? Can we leave the ice scoop in the ice or not? These are all questions that need to be addressed by your Infection Control Director. The improper handling of ice or the use of contaminated implements used to scoop ice are sources of contamination but they can also originate from your water supply mains, faulty plumbing at your facility allowing backflow from drains or from irregular or improperly cleaning of the ice machine and scoops.
Is using ice okay? Well here are some things to consider. Microbial contaminated ice has lead to several outbreaks of gastroenteritis from year to year and so my question to you is, "Do you want to give your patient ice that might be contaminated?"
Can we have or use an ice machine for our patient's? Ice machines have become an increasing concern over the years. They are notorious for containing heterotrophic plate count bacteria and from an aesthetic and a public health perspective, well, probably not a good idea. Heterotrophic bacteria counts in our drinking water, according to the EPA, should not exceed 500 CFU's per mL (colony-forming units) which has not changed since 1980's. However, it is not clear whether any opportunistic pathogens can survive freezing in an ice machine and then present a public health risk from the consumption of contaminated ice.
Can we leave the scoop in the ice or not? Not! There is already the possibility that the ice may contain Heterotrophic bacteria so you do not want to add to that burden. Leaving the scoop in the ice and or not keeping it clean can lead to contamination with Staphylococcus aureus, Pseudomonas and Aspergillus. So DON'T LEAVE THE SCOOP IN THE ICE.

Acinetobacter is a ubiquitous hydrophilic organism that can survive for long periods in the presence of water and has been recognized as a nosocomial pathogen increasing the morbidity and mortality of patients in the healthcare arena. It usually involves the respiratory track causing pneumonia but can also be involved in the bloodstream, abdomen, urine, wound and CSF infections. Acinetobacter has become increasingly resistant to antibiotic therapy and in recent years has caused serious outbreaks in healthcare facilities. Because of the antimicrobial resistance, Acinetobacter may result in a 25% mortality rate.
It is imperative that Healthcare workers employ good hand washing technique, good medication/injection/Intravenous technique, good environmental cleaning, good quality linen services, and good biohazardous waste removal. Hand washing is fundamental in the preventing and transmission of diseases and must be done frequently and effectively. Safe medication practice includes using an alcohol wipe and a new needle and syringe when withdrawing medication from multi-dose vials, not using IV bags for flush irrigation of saline locks, and wearing gloves when starting IV's to prevent cross contamination. Environmental cleaning should include the use of EPA approved disinfectant like hypochlorite. Cleaning with EPA products like hypochlorite in sinks and sinks traps, dusting under items on desk tops, the tops of doors and door jams and terminal cleaning throughout the facility reduces the possibility of environmentally cross contamination. Linen and Scrubs should be laundered in an approved off-site laundry service proficient in the care and handling of contaminated linen. On site and home laundry of scrubs is not supported by AORN, APIC, AAAHC or Joint Commission. The proper storage, containment and removal of biohazardous waste are both necessary and essential in the prevention of cross contamination of diseases.

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.