15 minute read
Raising the SBAR for safer cleanrooms during a pandemic
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 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.”
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.
—Gina Shaw
Sterile compounding exam gains traction
Certify Your Expertise
With sterile compounding becoming increasingly complex and regulated, the Board Certified Sterile Compounding Pharmacist (BCSCP) examination has both personal and organizational benefits that many pharmacists should consider, according to several compounding experts.
The certification—the newest issued by the Board of Pharmacy Specialties (BPS)—“is a credential for eligible pharmacists who, in their unique practice, are responsible for ensuring that sterile preparations meet the clinical needs of patients, satisfying quality, safety and environmental control requirements,” said Matthew Burrichter, PharmD, BCSCP, a clinical pharmacist at Penn Medicine, in Philadelphia, during the 2021 annual meeting of the National Home Infusion Association (NHIA).
“I’ve been working with sterile products for about six years and developed expertise, but previously there was no way to prove that [level of skill],” he noted. “Now, we have the opportunity for high-level proof of our expertise, which can provide improved recognition in an increasingly competitive marketplace. With the BCSCP, we can also become an educational resource for our colleagues.”
Dr. Burrichter predicted the BCSCP certificate will become preferred by most employers, with pharmacies that have significant compounding volume choosing the certified candidate over the noncertified one, all other things being equal. “It may also present the potential for increased salary and new opportunities,” he said. “COVID-19 has increased the use of home infusion centers for patients to get therapeutics, so there will be increased demand for more pharmacists with sterile compounding experience in the future. Pharmacists with this certification can elevate their organization’s entire practice of pharmacy with a demonstrated commitment to best practices.”
The BCSCP differs from most other BPS certifications because it is not focused on a specific clinical area, such as oncology, pediatrics, cardiovascular or nuclear pharmacy, but instead an operational area. “Someone I know who took the first exam said that it is really the first exam that a staff pharmacist, someone in the trenches, is likely to do,” Patricia Kienle, RPh, MPA, BCSCP, the director of accreditation and medication safety for Cardinal Health, told Specialty Pharmacy Continuum. “In general, the path to rise in pharmacy has been focused on coming up through the clinical ranks, but this certification is in an operational area and allows someone in the trenches to become board-certified based on very specific training and the ability to keep up with changing operational requirements,” added Ms. Kienle, who was among the first group of pharmacists to earn the certification in the fall of 2019.
Another Early Adopter
Brittany Singleton, PharmD, BCPS, BCSCP, a clinical assistant professor of pharmacy at Xavier University of Louisiana, in New Orleans, was one of the first two pharmacists in her state to earn the sterile compounding certification. “It really helps to inform my teaching,” Dr. Singleton said. “I teach the sterile compounding topics in the standard curriculum, and I also developed a sterile compounding elective course for my students. The certification has really helped me to build those courses to the best they can be in terms of sterile compoundng content and aseptic manipulations.”
She agreed that the BCSCP also makes a pharmacist more marketable. “I frequently have my students look at what pharmacy jobs are available, especially in our neighboring state of Texas, which has very strict requirements, and they see that many positions [encourage] advanced training and certification such as the BCSCP. I always encourage them to get the requisite experience and then apply to take the exam.”
As for how much experience is needed, Dr. Burrichter noted that 4,000 hours spent in the field of sterile products handling is required “before you can even sit for the [BCSCP] exam,” he said. “That’s a good amount of time to become familiar with the standards involved.” He noted that CriticalPoint also offers modules to prepare for the BCSCP, and that ASHP also offers a preparation course.
Dr. Singleton said she took the ASHP preparation course to ensure she was upto-date before sitting for the examination. “I’m very comfortable with this area and have worked in it for quite some time, and I teach it as well, but there were still a couple of questions that challenged me,” she said. “The item writers are good. You definitely have to prepare, no matter how experienced you are in this area.”
Ms. Kienle noted it would be hard to assess interest in the BCSCP yearover-year, because the first exam was given less than six months before the COVID-19 pandemic began spreading in the United States, and any figures for 2020 likely would not be representative. “I think it’s going to grow significantly,” she said. “There is so much more focus from state boards of pharmacy, as well as the FDA, on sterile compounding, and this is a way to establish your knowledge base. I see this as a growing opportunity.”
—Matthew Burrichter, PharmD, BCSCP
—Gina Shaw
Ms. Kienle is a member of the USP Compounding Expert Committee, but her comments are her own and not affi liated with nor endorsed by USP. Dr. Burrichter had no relevant fi nancial disclosures.
Web only
Thinking of taking the BCSCP exam? Know that it covers five key domains. For more details, see expanded version of this article at www. specialtypharmacycontinuum.com.
56% Rate of Compounding SOP Adherence ‘Crazy’
The USP’s sterile compounding standards have been in place for nearly two decades, and most large health systems, home infusion providers, specialty pharmacies and other practice sites that perform compounding employ technology to safeguard the sterile drug workflow process, according to field surveyors and other regulators.
But have compounders reached the optimal level of compliance? That’s what the Institute for Safe Medication Practices (ISMP) wanted to know. So last July, ISMP launched a Pulse Check survey (bit.ly/ 3qN37fF). More than 600 pharmacists, technicians and others allied with pharmacy responded.
The answer was that although progress in achieving compounding safety has been made, significant gaps remained. Three-fourths of respondents, for example, reported being aware of at least one pharmacy compounding error in the past 12 months, said Christina Michalek, RPh, the ISMP medication safety specialist who presented the findings during a virtual Omnicell Illuminate meeting. The errors ranged from incorrect dose or concentration to faulty labeling to wrong drug used (Table, page 16). Some were found and corrected before dispensing, Ms. Michalek said, while others came to light only after leaving the pharmacy.
She noted that the well-documented risks of sterile compounding were not just confined to the pharmacy. “It begins with the products brought into an organization,” she said. The areas of risk include when and how medications are prescribed and the processes of verification and communication, she noted. That risk also extends to the workplace environment,
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ADHERENCE
continued from page 15
Only 56% said always? That’s crazy,” Ms. Kienle told Specialty Pharmacy Continuum. “It shows that some people where the lack of standardized prac- still aren’t doing what they should have tices, production pressures and the been doing for decades. People need to absence of technology can take their toll, have procedures that match what they Ms. Michalek noted. actually do and that are compliant with
An even more complete picture of com- USP <797> and <800> standards, state pounding safety challenges emerged from regulations and best practices.” an open-ended question. By far the big- Although COVID-19 appears to have gest barrier, she said, “was the inabil- played little part in the survey results, ity of pharmacists to accurately verify Ms. Kienle said she is worried that the compounded sterile preparations using COVID-19 pandemic’s practice presindirect processes such as the syringe sures might have caused people to pull-back method.” Closely following become “even more lax on things like was the difficulty in complying with USP certification of their areas and maintainGeneral Chapters <797> and <800> standards. Rounding out Table. Sterile Compounding Errors the list were staff training and competency issues, a lack of Error Mentions, % technology, not enough work- Incorrect dose or concentration 58 space and heavy workloads. Insufficient leadership sup- Incorrect base solution 51 port and work supervision also were cited. Incorrect base solution volume 43
The survey also addressed Issue or error with labeling of CSP 41 technology. A total of 361 (including omission) respondents (57%) reported Incorrect reconstitution of drug 36 using at least some technolog- (volume or diluent) ical tools in sterile compounding. They included barcode Incorrect drug 35 verification with and with- Wrong preparation technique (e.g., 26 out images, multiple ingre- improper filtering, wrong tubing) dient compounding devices, gravimetric verification and Expired drug, base solution or CSP 16 robotic compounding. Wrong timing (e.g., preparing 12
Respondents were asked to antineoplastic on wrong date) rate the implementation level of nine ISMP-defined com- Omission of a drug 5 pounding best practices. The CSP, compounded sterile preparation greatest extent of implementation (73%) related to cleanroom/sterile compounding area practices, ing and really upgrading the environincluding having enough workbenches to mental pieces” that are fundamental to support only one staff member at a time USP <797> and <800> standards. per primary engineering control—laminar airflow workbench, biological safety cabi- Compounding Stewards net, compounding aseptic isolator or com- Ms. Michalek ended on an upbeat pounding aseptic containment isolator. note. “Pharmacists and technicians have
The survey also focused on standard done some amazing work to continuoperating procedures (SOPs). Were they ally improve the care and delivery of defined and what was the level of com- sterile injectable medication,” she said. pliance? More than half of respondents “As stewards of medication use, they (56%) reported that SOPs were “defined are really in the best position to move and always followed.” About one-third forward with more improvements and (34%) said they were defined and “often more safety around compounded sterile followed,” while 10% said they were “never, rarely or sometimes” defined preparations.” —Bruce Buckley and followed. Patricia C. Kienle, RPh, MPA, the director of accreditation and medication safeMs. Michalek reported no relevant fi nancial disclosures. Ms. Kienle is a member of the USP Compounding Expert Committee, ty at Cardinal Health, found the results but her comments are her own and not pertaining to SOPs “pretty alarming. affi liated with nor endorsed by USP.
