Hand and Glove Hygiene Keys to Safe Compounding

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1 Page 1 of 5 print this article Clinical ISSUE: MARCH 2012 VOLUME: 39 Hand and Glove Hygiene Keys to Safe Compounding by Steve Frandzel New Orleans Improper hand hygiene is a common factor in the spread of hospital-acquired infections. Prevention programs typically hammer away at making sure that clinicians wash their hands as they move among patients rooms. Yet, harmful microorganisms can just as easily find their way to patients when pharmacy staff don t follow best practices when compounding sterile preparations. To reduce the transmission of pathogens, pharmacists at NewYork-Presbyterian Hospital, Columbia University Medical Center, in New York City, launched a plan to improve compliance among pharmacy staffers who make compounded drugs in IV admixture clean rooms. They presented their findings at the 2011 Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP). We wanted to reduce the potential risk of transmission from the staff who are making sterile products for patients, said Vickie L. Powell, MS, RPh, FASHP, site director of the pharmacy and co-author of the study. That can happen in many ways, such as not washing your hands, then touching the wrong thing and then touching the compound you re making. You can contribute to infection risk. Numerous organisms can grow and potentially be transmitted. We decided that even though we put people through extensive training about sterile compounding safety, we would conduct random cultures of gloved fingers to see how clean they were as a way to monitor, evaluate and document compliance. About 100 pharmacy staff participated in the testing. The random culturing revealed that only 30% of the staff had no colony-forming units of microorganisms growing on their gloved fingertips before beginning compounding procedures. The low percentage suggested inadequate compliance with procedures as described by US Pharmacopeia (USP) Chapter <797>, which details the requirements for compounding sterile preparations. Its intent is to decrease the contamination of sterile products and protect the compounder from unwanted exposure to pharmaceutical products.

2 Page 2 of 5 Staff members who were noncompliant as judged by microbial growth on their cultures were required to undergo re-education and training on proper procedures, a process that took about a week. (The microbes detected included Corynebacterium; coagulase-negative Staphylococcus; Micrococcus; Pseudomonas; Streptococcus; and Kytococcus.) We have them review videos and conduct one-on-one instruction, then we observe them at their work, which is followed by another culture, Ms. Powell said. I think people are inclined to do the right thing, but sometimes they take shortcuts if you re not watchful. It s in our best interest to do what we can to assure that our patients are safe. Since the program s initiation in 2010, an average of 95% of the pharmacy staff s cultures have been free of microbial growth. Ongoing monthly monitoring, which includes random cultures and training, has resulted in compliance with USP <797> and Joint Commission medication management standards, according to Ms. Powell. The team concluded that strict adherence to proper hand washing and sterile compounding procedures decreases microbial growth and virtually eliminates the risk for nosocomial infections from compounded admixtures. Developing strict policies and procedures can ensure quality outcomes for our patients. Angela Cassano, PharmD, BCPS, president of Pharmfusion Consulting in Midlothian, Va., commented that it is encouraging to see that programs such as the one at Columbia University Medical Center are paying attention and taking seriously USP <797>, and recognizing that any reduction in contamination rates are an improvement. I m not surprised to see that in this study, compliance rates among staff increased after a formalized program was put in place, she added. When employees see that you re serious about an initiative, you re likely to get greater buy-in. Going from 30% compliance to 95% is significant and shows that their efforts have been very effective. Dr. Cassano added that managers who are responsible for compounding operations often assert that the only way to effectively reduce contamination is to invest millions in rebuilding the clean room, but this program shows clearly that a difference can result from a structured training program, and more importantly, regular compliance oversight. Break Out the Gloves: A Battle Between Sterile And Nonsterile Garb The USP <797> mandate also was the impetus for research conducted at Indiana University Health North Hospital near Indianapolis more precisely, a 2007 change to the standard that requires the use of sterile gloves when compounding sterile products for hospital use. We were having problems obtaining supplies of sterile gloves from the manufacturers, said Shawn Van Scoik, RPh, a pharmacist at the hospital and study co-author. At first, it was an availability issue. With all the hospitals wanting to be in compliance, you couldn t get sterile gloves for a while. In addition, the new mandate for sterile gloves contributed significantly to increased pharmacy costs.

3 Page 3 of 5 Ms. Van Scoik and her colleague, Stacy Snyder, PharmD, BCPS, lead study author, wondered whether the use of sterile gloves significantly decreased contamination rates. A literature search turned up a single study of gloves and contamination rates that found beneficial effects (Am J Health Syst Pharm 2007;64: ). The two pharmacists decided to conduct a prospective study to find out if they could replicate those results. The study s objective was to compare the contamination rates between sterile and nonsterile gloves using tryptic soy broth (TSB) mini-bags and tryptic soy agar (TSA) fingertip plates. Contamination rates were evaluated to assess if proper aseptic technique and routine sanitization are comparable for both scenarios. Four experimental arms were created: new non-sterile gloves with routine disinfection, nonsterile gloves that had been used in compounding for at least an hour with routine disinfection, new sterile gloves with routine disinfection and sterile gloves that had been used in compounding for at least an hour with routine disinfection. Sterile 70% isopropyl alcohol (IPA) was the disinfectant used throughout the study, the agent mandated by USP <797>. With the exception of the type of gloves used, all other aspects of the trial were performed according to the same guidelines. All compounding and testing was completed by pharmacy technicians who were trained in aseptic sterile technique and who routinely worked in the IV room, compounding sterile products. After routine hygiene and garbing with personal protective equipment, an ampoule of TSB growth medium was opened and transferred to a vial of TSB growth medium. Twenty 1-mL aliquots of the growth medium were then transferred to a TSB mini-bag. The technicians placed fingertips of each hand on the TSA plates. When testing was completed, the TSB mini-bags (considered the final product) were stored and incubated at room temperature for 14 days, based on manufacturer guidelines. The TSA plates were stored and incubated at room temperature for a minimum of three days. The TSB mini-bags were assessed for clarity and evidence of particulates. The agar fingertip plates were assessed for evidence of microbial colonies. For the mini-bag aseptic technique verification, 83 gloves (45 nonsterile, 38 sterile) were tested; for the agar fingertip testing, 184 gloves (104 nonsterile, 80 sterile) were tested. The overall contamination rate of the agar plates was 18.2%, and overall contamination rate of the mini-bags was 5.1%. No significant difference in bacterial growth in TSB mini-bags was found between the use of sterile versus nonsterile gloves (P=0.855), and there was no significant difference in contamination risk in the mini-bags (P=0.293) or on TSA plates (P=0.21) based on whether the test was completed with new gloves or gloves used for at least one hour of compounding. The likelihood of finding bacterial growth on nonsterile gloves was 1.3 times that of finding growth on sterile gloves. However, that glove contamination did not appear to

4 Page 4 of 5 transfer to the TSB mini-bags: No statistically significant association was found between fingertip contamination and contamination of the mini-bags, according to the investigators. Using nonsterile gloves had no negative effect in our study, which is what we had anticipated, Ms. van Scoik said. We found that if you have fingertip contamination but use good aseptic techniques, the contamination doesn t translate to the final product. Nonsterile gloves may therefore be an economical and safe alternative to sterile gloves for medium risk level compounding. She strongly emphasized that the study s small size means its findings must be validated in a larger population. Kudos for Study, But Approbation On Contamination Rate Eric Kastango, MBA, RPh, FASHP, president and CEO of Clinical IQ, LLC, a health care consulting firm in Madison, N.J., and a member of the USP Compounding Expert Committee, applauded the researchers initiative. He agreed with them that the sample size is too small to reach any meaningful comparison between sterile and nonsterile gloves with regard to contamination rates in this context. And the study clearly demonstrates that nonsterile gloves are dirty right out of the package, he noted. But what most concerned him was the overall contamination rate of 5.1% reported in the study, which he said is far higher than the industry standard rate of 0.1% for pharmaceutical compounding. I d say that their rate of contamination is totally unacceptable, Mr. Kastango said. And it s hard to differentiate if it was the result of the gloves or because of the clinicians aseptic technique. I would have to say that the fingertip contamination from the nonsterile gloves did get transferred to the final product. More generally, he emphasized that the widespread zeal to save money by using nonsterile gloves is understandable but misplaced. In a typical compounding operation, the additional cost of sterile gloves ranges from $10,000 to $12,000 annually, he noted. In this day and age, that s not an insignificant amount of money. But it s the equivalent of two drug vials or perhaps three days worth of IV drug waste, and one-third of the cost of a hospital-acquired infection, which has been estimated at $34,000. Mr. Kastango added, The decision the USP committee made in requiring sterile gloves over nonsterile gloves is that you start with a pair of gloves with zero microbial bioburden and that it s a very inexpensive way to maintain a state of control and prevent the risk for contamination and infections. It s critical to make sure we re giving patients the safest, best opportunity to have the lowest risk for contamination from compounded sterile preparations. Criticisms Deemed Valid, but Study Design May Be at Fault The authors acknowledged the validity of Mr. Kastango s criticism, although they hesitated to extrapolate any potential contamination rate based on their small sample size. One particular reason is that we were extremely conservative in how we interpreted the TSB

5 Page 5 of 5 bags, Dr. Snyder said. Any evidence of fibrils or turbidity that could be due to protein agglomeration or denaturation, rather than microbial growth, were interpreted as having positive microbial contamination. We did not plate out or speciate the contents of the bags. She said they incorporated fingertip testing because the new version of USP <797> states that all personnel who compound sterile preparations must complete a gloved fingertip sampling procedure as part of periodic competency evaluations. After completing our pilot study, we did identify that the majority of our failures were possibly associated with a particular technician, Dr. Snyder continued, noting that the study involved only four technicians, because it was simply a pilot study. Following the completion of this study and reviewing the results, all of our technicians went through extensive direct observational study, as well as didactic training and retesting. The authors also examined the possibility of expanding the study to achieve statistical significance to match the industry standard contamination rate of 0.1% for aseptically produced preparations; however, their statisticians calculated that more than 2,400 samples per study arm would be required, which was not feasible. We are encouraged that our small pilot study presented as a poster at the ASHP Midyear meeting has stimulated discussion, said Dr. Snyder. We hope that larger studies can be conducted to fully elucidate the impact of sterile versus nonsterile gloves with routine disinfection in parallel with the adherence to rigorous sterile technique on the part of technicians.