Rose Seavey, RN, BS, MBA, CNOR, CRCST, CSPDT, is the president/CEO of Seavey Healthcare Consulting.
Q: Why is sterilization such a hot and challenging topic for ambulatory surgery centers?
Rose Seavey: Sterilization is definitely under the spotlight, and the [news] headlines explain why. As a result, the accreditors are really pushing the need for policies and procedures that reflect the most current standards and recommended practices from published organizations. [ASCs'] policies, procedures, etc. need to be based on the guidelines from organizations that actually write our standards. Those really should be AORN, AAMI and the CDC.
For instance, The Joint Commission states that, based on indentified risk, the hospital sets goals to minimize the possibility of transmitting infection. The ambulatory surgery standards pretty much say the same thing. Basically you have to have policies written around limiting the transmission of infections associated with the use of medical equipment, devices and supplies. They weren't that specific before. The Joint Commission is now also grouping high-level disinfection (HLD) along with sterilization. In the past, HLD was grouped with medium and low-level disinfection. The Joint Commission realized HLD is more closely related to sterilization and should be scored as such.
The issue with ASCs is they don't usually have all the resources — personnel or financial — to keep up to date, know what is going on and have somebody specifically addressing the most current standards relating to sterilization and disinfection . That's why CMS and everyone else is saying you need to have — at minimum — an infection preventionist overseeing the program, even if this person is just part-time.
Editor's note: To view a "Sterile Processing Best Practices Audit Check List" developed by Ms. Seavey, visit http://seaveyhealthcareconsulting.com/id75.html. Also, ASCs can keep an eye out for a new APIC ANYWHERE online course on disinfection and sterilization under development by Ms. Seavey for the Association for Professionals in Infection Control and Epidemiology (APIC).
Q: There is still confusion and poor practices surrounding flash sterilization. What do ASCs need to know about flashing?
RS: The Association of Medical Instrumentation (AAMI) created a summit last year of all professional organizations, accreditors and regulatory organizations to look at flashing. The group determined that the term flash is no longer an accurate term. "Immediate-use steam sterilization" is the new term. AAMI release a multi-society position statement (found at www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf) which talks about the need for practices built around immediate-use steam sterilization and following recommended practices. So far seven organizations have signed off on it and have endorsed it.
The challenge is that the accrediting agencies do not really want facilities to immediate-use steam sterilize the exact same items over and over again. The other huge piece is [ASCs] must be following the most current validated guidelines for cleaning, sterilization exposure time and the use of rigid containers for transporting, even if it's just a few feet. And the cleaning needs to take place in a designated decontamination area using detergents, pure water or a higher quality of water than just tap water.
Q: What else should ASCs know about sterilization concerning reprocessing of equipment?
RS: The other thing [accreditors and regulatory agencies] are really pushing is the need for anybody involved in the different steps of reprocessing to be knowledgeable about all of the different types of sterilizers, the cleaning methods and the different types of sterilizers, and various cycles types. The administrators should be responsible for ensuring that the staff has the appropriate training, education and resources. [ASCs] need to make sure they are following all the process monitoring systems, which include physical, chemical and biological monitoring according to the manufacturer's instructions.
They also must have sufficient instrument inventories to be able to properly reprocess these in between cases without having to rush the process. For example, you can't do 20 eye cases with four sets of instruments because you need enough time to follow the manufacturer's instructions to properly clean, and sterilize them. Some manufacturer's instructions for cleaning may take up to 30 minutes for irrigation, ultrasonic cleaning, assembly, etc., so there must be enough time to do that. Facilities must have enough inventory to allow for proper time to reprocess the equipment. The tagline I like to use is, "Convenience and economics should never trump patient safety."
Q: Are ASCs currently facing any other major sterilization challenges?
RS: What I'm seeing a lot of in ASCs and hospitals is the constant borrowing of loaner instrumentation for a variety of reasons. It's not just orthopedics. We're seeing it in neuro, GYN, pediatrics and quite a few other specialties. The problem is that if [ASCs] don't receive the loaner instrumentation in time, they must use immediate-use steam sterilization. There should be some written policies and procedures and a loaner instrumentation management program in place. It should be established that [loaner] items need to be received at least 24 hours before the case so there's enough time to reprocess them adequately. If there are implants, you're also going to have to run biologicals and you have to have those results before you release the implants for use.
The other issue is [ASCs] don't always get the manufacturer's validated instructions with the loaner items. We sometimes have to ask for those. We need to have the most current recommendations that are in writing from the company. We have to reprocess [the loaner item], even if comes already delivered from another facility in a “sterile” package. We need to take it apart, assume it's contaminated, put it through decontamination, do quality control checks, repackage and resterilize it. We have to have the documentation that we followed all of the quality checks because the patient deserves to know we have done that.
Q: Are there any tools or resources ASCs can use to help tackle these loaner instrumentation challenges?
RS: The Orthopedic Council of the International Association of Healthcare Central Service Materiel Management (IAHCSMM) is creating a sample policy that facilities should be able to follow on loaner instrumentation. They're hoping to get that policy out after their annual conference, which is being held the beginning of May. They're also working on an updated position statement on loaner instrumentation.
Here's a checklist for loaner instrumentation that may be helpful:
- Notify sterile reprocessing department about loaners prior to receiving them.
- Ensure the decontamination facility receives existing loaner sets at least two working days (48 hours) in advance and new sets at least three working days (72 hours) before scheduled case.
- Make inventory list available.
- Provide written recommendations for cleaning, packaging and sterilization available.
- Complete inventory and quality check.
- Label and number multiple trays (patient name, surgeon).
- Ensure trays do not exceed 25 pounds.
- Check to make sure that all instruments are in good condition (no rusting, no pitting).
- Check to make sure that the container is in good condition (no rusting, tape, residue, etc.).
Learn more about Seavey Healthcare Consulting at www.seaveyhealthcareconsulting.com.
Thank you to APIC (www.apic.org) for arranging this interview.