One of the biggest challenges facing the practice of anesthesia are recent changes in infection control rules, according to Clifford Gevirtz, MD, an anesthesiologist with Somnia Anesthesia Services who practices throughout New York and Long Island, N.Y. Some anesthesiologists may be struggling with the new rules, as is evidenced by recent news of violations throughout the country, including a report stating that 25 percent of ASCs in New Jersey are reusing single-dose vials, a violation of CMS standards.
Dr. Gevirtz highlights some of the major areas in which some anesthesiologists may be failing to comply with the rules and discusses what they and their organizations might do to help to keep them in compliance.
1. Follow the guidelines in USP <797>. U.S Pharmacopeia released voluntary guidelines in a publication titled " Guidebook to Pharmaceutical Compounding — Sterile Preparations," also known as USP <797>. "While USP says it's a voluntary guideline, in a court of law, when dealing with Medicare, other insurers and agencies, the guidelines are considered to be the standard of care," Dr. Gevirtz says. "If we dismiss those stakeholders by not following USP<797>, we're risking major problems. It's really good practice to follow them."
2. All medications should be drawn into labeled syringes. On an anesthesia work station, propofol is the only substance that looks like a white, milky substance. Since there is no other substance to confuse it with, the need to label every syringe with propofol may have some anesthesiologists questioning the necessity of that requirement, Dr. Gevirtz says. But according to USP <797>, they must be labeled. "The real reason is not so much to identify the syringe as containing propofol but rather to give practitioners the opportunity to date it and time them so everyone knows exactly when this was drawn," he says.
3. Do not leave medication unattended. In the past, anesthesiologists would set up their rooms, draw up all of the drugs for their anesthesia cart and prepare for a case before seeing the patient in the pre-op area or performing other tasks prior to the procedure. But according to <797>, the new requirement mandates that medication never, at any point, be left unattended. "It's definitely a different way of thinking," Dr. Gevirtz says. "Usually what has happened in the past is that syringes would be drawn up for an entire day. If you had 10 cases, you might draw syringes and label them for narcotics, muscle relaxants, etc. — you'd really get everything ready to go in advance of the cases. You'd draw them up and administer them as each case came into the room. That is no longer an acceptable way to work."
The guidelines also state that the medication must be disposed of if it's not used within an hour of being drawn. "As anesthesiologists, we work with surgical staff to decrease turnover time," he says. "But now we need to slow down a bit and draw medications for each case as it occurs, and not in advance of the three or four cases that are in the queue."
4. Unit dose medications are prohibited from use for more than one patient. Anesthesiologists who take a single vial of propofol and draw it into four or five syringes are in violation of the rules because the labeling on the drug states it is for "single-use only."
"When carrying out the induction of anesthesia for a simple case, anesthesiologists may use 20ccs. If that's pulled from a 100cc vial, 80ccs are unusable because you can't go back into that vial," he says. "It's fire it once and that's it. I can see where that might be considered wasteful.
"That scenario in this already tight propofol environment exacerbates the challenge of trying to run an OR using propofol appropriately," he says. "Since the supply is already constrained, single use makes it more constrained. In order to get more propofol from distributors, we're ordering unusual sizes — 50cc, 100cc sizes — to accommodate simple cases but it seems some practitioners are still divvying up the vials, which is absolutely not allowed according to USP."
5. Syringes should only be used once. The strict letter of the law according to the FDA and USP mandates that a syringe is a single-use device, Dr. Gevirtz says. Once you inject a medication and have used the syringe, you must throw away the syringe even if you want to use it again for the same drug and patient.
"It has not been uncommon to find people who would draw a muscle relaxant, give the patient 3ccs or 4ccs and empty the syringe. Now practitioners must start with a fresh syringe even if it's used on the same patient," he says. "It's a real paradigm shift from how we've practiced in the past. We really have to be fastidious in order to avoid running afoul of Medicare guidelines."
Tips for ASCs to comply with infection control rules
1. Check anesthesia cart in the morning. An administrator of an ASC should open the drawers of the anesthesia cart before the anesthesiologists arrive to see if it already contains IV bags filled with drugs or syringes all of which were drawn up the night before. "You have people preparing for the next day," Dr. Gevirtz says. "They may have already drawn up syringes for the first case in the morning to get a jump on things, so you must do an early morning audit."
2. Observe anesthesiologists during cases. The circulating nurse should observe anesthesiologists' processes to identify and then report any possible violations. "Observe them drawing up medication and ask the following questions: Are they reusing syringes, are they throwing away the things they're supposed to dispose of," Dr. Gevirtz says. "While nobody wants to be in the role of monitor or tattletale, the reality is that sloppy practice has to be identified quickly before it imperils the ASC and the patient. It's important to conduct ad hoc mini audits every now and then."
3. Take proactive approach to correcting violations. Once any red flags are observed or reported, the ASC should document the problem and explain to the practitioner that such a practice is not acceptable, Dr. Gevirtz says. "Have an in-service with the anesthesiologists during a lunch break. If you start to see a bad pattern, keep documenting it. Unfortunately, if the issue is not resolved, you may need to part ways for everyone's good and because it's the law. If a Medicare inspector pulls open a drawer and finds labeled syringes and open IV bags, your ASC will be in big trouble."
Thank you to Somnia Anesthesia Services for arranging this interview.