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Specialty Pharmacy Continuum • May/June 2021
POLICY
Tool addresses unsanitary conditions, PPE shortages and other issues during pandemic
The SBAR Method for Cleanroom Compliance If the last several years of hurricanes and floods, changes in sterile compounding regulations and the COVID-19 pandemic have demonstrated anything, it’s that preparation and communication for planned or unplanned cleanroom closures or equipment shortages related to remodeling, inspection reports or natural disasters are essential. At the 2021 annual meeting of the National Home Infusion Association (NHIA), Gene Decaminada, BS Pharm, RPh, the pharmacy manager with MCP Home Infusion Pharmacy at Yale New Haven Health (YNHH) Services, in Connecticut, discussed some of these possible interruptions in the cleanroom process and methods for dealing with them in a clear and consistent way. “It is important to note that referring to the list of insanitary conditions involves potential safety concerns, not just an FDA citation,” he said. Common reasons for closures or interruptions include inspections from the State Board of Pharmacy and the FDA, Mr. Decaminada said. “I’ve been through many FDA inspections over the past few years, and they can be on-site for the better part of seven days or more. Other issues that can lead to process interruptions include cleanroom growth, such as actionable growth (i.e., mold and/or fungus) in your ISO [International Organization for Standardization] 5 areas; remodels and updates that require you to shut down your cleanroom or relocate your processes for days or weeks; and everything from harsh winters to power failures to floods. So it’s important to consider how these situations might change your cleanroom policies or practices with regard to patient safety and achieving a controlled environment.”
Unsanitary Conditions to Heed Mr. Decaminada cited a list of unsanitary conditions that could result in several FDA Form 483 citations, such as anything from missed microbial contamination under laminar flow hoods to moisture buildup from HVAC ductwork above the cleanroom, to processing beta-lactams and non–beta-lactams in the same laminar flow hood, to inadequate donning and doffing processes for personal protective equipment (PPE). “During site inspections, the FDA has also questioned proper smoke studies performed in laminar flow hoods by total parenteral nutrition compounders,” he said. “They want to see active compounding or mimicked dynamic compounding during smoke pattern testing. Make sure you are saving those videos for review with your cleanroom staff.”
Processes for conserving PPE, given pandemic-related shortages, must also be documented, Mr. Decaminada said. “You can’t just say you’re conserving PPE without building an addendum into your standard operating procedure [SOP]. If your SOP states to don a new gown every time someone exits the cleanroom and you’ve had to change to one gown per person per day for conservation purposes, you have to back up that SOP addendum in writing.” Other conservation measures he recommended include limiting the number of personnel engaged in compounding activities, staging supplies outside the compounding area to minimize trips into the cleanroom, and resanitizing sterile gloves after exiting ISO 5 areas.
Communication Is Key To communicate these changes to your cleanroom policies and PPE conservation plans if you have a busy pharmacy or multiple cleanrooms, Mr. Decaminada recommended a framing mechanism known as SBAR: Situation, Background, Assessment and Recommendation, which is endorsed by the Institute for Healthcare Improvement (IHI). “The SBAR communications method has been used successfully in many hospitals and health systems,” he said. “It’s an easy-to-remember method for structuring any conversation, but particularly critical ones requiring immediate attention and action. For example, we use SBAR at Yale New Haven Health for communicating any decisions about PPE conservation that has to come from pharmacy leadership to the cleanroom staff.” The SBAR technique, developed by Michael Leonard, MD, a physician leader for patient safety at Kaiser Permanente of Colorado, includes the following steps: Situation: a concise statement of the problem; Background: pertinent, brief information related to the situation and what has led up to it; Assessment: analysis and consideration of options; and Recommendation: action requested or recommended. The Department of Pharmacy at the University of Michigan, in Ann Arbor, has been using the SBAR method for several years, according to compounding
The University of Michigan’s SBAR Situation: The COVID-19 pandemic is constraining staff resources in compounding and the pharmacy needs to free up staff time.
Background: Current USP standards for low- and medium-risk compounds require media fill testing every 12 months. Only high-risk compounds require testing every six months. Assessment: The pharmacy does only low- and medium-risk compounding. We assess that it is acceptable to move to a 12-month frequency for media fill testing. Recommendation: Implement 12-month testing intervals until COVID-19–related staffing constraints are resolved. compliance team manager Jamie Tharp, PharmD. “We employ it in both verbal communication and in writing. So many people can struggle with how to tell a story effectively and get off the beaten path. SBAR readies the listener to receive your assessment and recommendations.” The “background” segment of SBAR often can be the longest, Dr. Tharp said. “It’s where you may spend a lot of time talking about the rules, the standards and the regulations. I often use this section to provide references that could help support my transmission of information. Overall, we try to keep SBARs to less than a page, but if there is a lot of content or data, we might make an exhibit for a second page, or use a separate reference section if a lot of technical policies, laws and standards are involved.” SBAR proved very useful to the compounding compliance team during COVID-19, Dr. Tharp said. “For example, our standard had been to do media fill tests for aseptic technique every six months, which was above and beyond the minimum required. It was part of our commitment to best practices and preparing for future standards. But during the pandemic we had a crunch with staffing, and wrote an SBAR to inform senior leadership about what we thought would be a good way to conserve staffing resources [see box]. “After the SBAR was [routed] through our leadership and approved, we posted the SBAR with the decision to our policy webpage as an interim plan during the pandemic,” Dr. Tharp said. “SBAR is also
very useful as we audit the work we are doing at our compounding sites. If one of my technicians has found an issue, such as damaged equipment or someone not following a policy, I will ask them to share an SBAR with a supervisor. They are full of factual information and can take the sting out of a recommendation for improvement.” In addition, SBARs are easy to write, Dr. Tharp said. “I can write even a very detailed SBAR in 90 minutes or less, and if it’s very simple, in a quick five-minute email. It’s particularly helpful if you have to escalate details to stakeholders outside the pharmacy, because it gives necessary background to people who might not be involved in the day-to-day work. It also provides a useful breakdown of content that allows people who already know the background intimately to zoom right to the recommendations.” The only change Dr. Tharp would make to the SBAR method would be to add a D for Decision at the end. “That’s the piece I think is missing. You should have a section at the end of your SBAR (D) to record what decision was made based on your recommendation. Was it accepted or not? Maybe you gave two options, preferred and alternative, and you need a record as to which one was accepted. It’s amazing how much clarity this method can bring to your decisionmaking process.” —Gina Shaw The sources reported no relevant financial disclosures.
