Abide by Guidelines To Prevent Infection in Sterile Compounding
by George Ochoa
Infection outbreaks caused by sterile compounding errors have been an ongoing problem, starting with a case in Nebraska in 1990 to more recent ones in Alabama and Tennessee in 2011. The U.S. Pharmacopeia (USP) Chapter <797> was designed to minimize such outbreaks, but it can only be effective when its requirements are strictly followed, and that is not always the case, according to an expert speaking at a webinar sponsored by Wolters Kluwer Health, provider of the USP compliance software Simplifi 797.
USP <797>, which applies to preadministration manipulations of compounded sterile preparations and to all compounding personnel and facilities, was introduced in its first iteration in 2004 and in a revised form in 2008. (The next revision is in process and is slated for completion in 2013.)
Although the <797> guidelines have been in place and there are many levels of oversight governing compounding and dispensing activities—the FDA, state boards of pharmacy, pharmacists and pharmacy technicians—cases of noncompliance do occur, noted webinar presenter Keith H. St. John, MS, CIC, director of clinical epidemiology at Wolters Kluwer Health, in Bellevue, Wash. Because technicians and other pharmacy staff are “directly involved in compounding and dispensing activities … we need to empower [them] to speak up when things are not done according to standard operating procedures,” said Mr. St. John.
According to Eric S. Kastango, MBA, RPh, FASHP, there are particular requirements of <797> that tend to be problem areas for noncompliance.
Mr. Kastango is president and CEO of the consulting company Clinical IQ, LLC, in Florham Park, N.J., and was not affiliated with the webinar. Aspects of <797> that often are overlooked in pharmacies include “adherence to proper garbing and hand hygiene, the use of sterile gloves, sterile alcohol, proper disinfection of components and disinfection of injection ports and vial septums.”
Infection Control Requirements
Reviewing some specific infection control requirements in <797>, Mr. St. John said, “The goal is to reduce the bioburden in compounding areas.” The chapter outlines specific frequency requirements. For example, there should be daily cleaning/disinfection of ISO Class 5 surfaces and equipment, work surfaces near the ISO Class 5 area, floors and shipping containers.
A major aim is to keep the environment free of particulates. “Dust particles can carry microbes, [which] then can eventually end up in the sterile compounding area if there’s a breach in aseptic technique, and, of course, that will eventually lead to contamination,” said Mr. St. John. “We’re trying to reduce downstream contamination risk by minimizing particulates and having the environment as clean as possible.”
Primary engineering controls, such as a hood or glovebox, protect the direct compounding area from contamination. “Pharmacists and infection preventionists may appropriately have a partnership in evaluating [these] instruments,” said Mr. St. John. “You have to do a critical evaluation of what’s best for your pharmacy.”
Personnel most often are the source of microbial contamination in aseptic processing. Compounding personnel need to wear hairnets, beard covers and face masks, as well as gowns, gloves and shoe covers, said Mr. St. John. “Hand hygiene is paramount for safety in preparing medications,” he added, noting that Chapter <797> includes specific information about how hands should be cleaned, including washing with soap and water up to the elbows and using an alcohol-based surgical hand scrub with persistent antimicrobial activity.
Environmental Sampling
Environmental sampling, said Mr. St. John, “is one of the most contentious sections in the chapter.” The Centers for Disease Control and Prevention (CDC) does not advocate routine microbial environmental culturing (sampling) of inanimate surfaces in the absence of an outbreak, whereas the FDA requires sterile processing operations in manufacturing facilities to perform daily monitoring of viable air, surface and glove fingertip samples. In its current version, <797> moved away from the FDA’s position and toward the CDC’s—but still requires some routine sampling. As far as the anticipated revision goes, Mr. St. John said, “the verdict is still out on this.”
Aseptic technique in sterile compounding requires understanding of “first-air,” the air exiting the high-efficiency particulate air (HEPA) filter, which is virtually free of particulate contaminants, said Mr. St. John. All critical manipulations must occur in the first-air zone.
A written quality assurance procedure is necessary and important for training and assessing competency, according to Mr. St. John. It is “unacceptable” to have no written procedures, he said. “This is an area where you have to have processes and checks.” Additionally, he said, “There needs to be a primary oversight person [who] looks at the overall process.”
If a pharmacy wants to improve its <797> compliance, said Mr. Kastango, those who work there “should understand where they are relative to compliance—do a gap analysis.” Additionally, he said, “They should go to gemba,” using the Japanese term for going to the workplace and seeing what is done. An observer should “sit in the work area and watch what people are doing; observe people. … Visually audit whether people are following procedures.”
A consulting company, such as Mr. Kastango’s, can be of assistance. As a consultant to hospital pharmacies, he said, “I help them design <797>-compliant clean rooms, and help them to develop policies and procedures.” He also does audits when pharmacies want a third-party view.
Checklists can be useful for monitoring and improving performance. The infection preventionist and the pharmacist can partner to develop checklists. <797> has examples of checklists, but, “it’s very important that you tailor this to your specific situation. More important than just filling out checklists is to have a way to analyze the results and provide feedback to staff on compliance.” said Mr. St. John.
Mr. Kastango concluded, “You have to make sure people understand [infection control procedures] and that that understanding translates correctly into behaviors in the clean room.”
USP <797>, which applies to preadministration manipulations of compounded sterile preparations and to all compounding personnel and facilities, was introduced in its first iteration in 2004 and in a revised form in 2008. (The next revision is in process and is slated for completion in 2013.)
Although the <797> guidelines have been in place and there are many levels of oversight governing compounding and dispensing activities—the FDA, state boards of pharmacy, pharmacists and pharmacy technicians—cases of noncompliance do occur, noted webinar presenter Keith H. St. John, MS, CIC, director of clinical epidemiology at Wolters Kluwer Health, in Bellevue, Wash. Because technicians and other pharmacy staff are “directly involved in compounding and dispensing activities … we need to empower [them] to speak up when things are not done according to standard operating procedures,” said Mr. St. John.
According to Eric S. Kastango, MBA, RPh, FASHP, there are particular requirements of <797> that tend to be problem areas for noncompliance.
Mr. Kastango is president and CEO of the consulting company Clinical IQ, LLC, in Florham Park, N.J., and was not affiliated with the webinar. Aspects of <797> that often are overlooked in pharmacies include “adherence to proper garbing and hand hygiene, the use of sterile gloves, sterile alcohol, proper disinfection of components and disinfection of injection ports and vial septums.”
Infection Control Requirements
Reviewing some specific infection control requirements in <797>, Mr. St. John said, “The goal is to reduce the bioburden in compounding areas.” The chapter outlines specific frequency requirements. For example, there should be daily cleaning/disinfection of ISO Class 5 surfaces and equipment, work surfaces near the ISO Class 5 area, floors and shipping containers.
A major aim is to keep the environment free of particulates. “Dust particles can carry microbes, [which] then can eventually end up in the sterile compounding area if there’s a breach in aseptic technique, and, of course, that will eventually lead to contamination,” said Mr. St. John. “We’re trying to reduce downstream contamination risk by minimizing particulates and having the environment as clean as possible.”
Primary engineering controls, such as a hood or glovebox, protect the direct compounding area from contamination. “Pharmacists and infection preventionists may appropriately have a partnership in evaluating [these] instruments,” said Mr. St. John. “You have to do a critical evaluation of what’s best for your pharmacy.”
Personnel most often are the source of microbial contamination in aseptic processing. Compounding personnel need to wear hairnets, beard covers and face masks, as well as gowns, gloves and shoe covers, said Mr. St. John. “Hand hygiene is paramount for safety in preparing medications,” he added, noting that Chapter <797> includes specific information about how hands should be cleaned, including washing with soap and water up to the elbows and using an alcohol-based surgical hand scrub with persistent antimicrobial activity.
Environmental Sampling
Environmental sampling, said Mr. St. John, “is one of the most contentious sections in the chapter.” The Centers for Disease Control and Prevention (CDC) does not advocate routine microbial environmental culturing (sampling) of inanimate surfaces in the absence of an outbreak, whereas the FDA requires sterile processing operations in manufacturing facilities to perform daily monitoring of viable air, surface and glove fingertip samples. In its current version, <797> moved away from the FDA’s position and toward the CDC’s—but still requires some routine sampling. As far as the anticipated revision goes, Mr. St. John said, “the verdict is still out on this.”
Aseptic technique in sterile compounding requires understanding of “first-air,” the air exiting the high-efficiency particulate air (HEPA) filter, which is virtually free of particulate contaminants, said Mr. St. John. All critical manipulations must occur in the first-air zone.
A written quality assurance procedure is necessary and important for training and assessing competency, according to Mr. St. John. It is “unacceptable” to have no written procedures, he said. “This is an area where you have to have processes and checks.” Additionally, he said, “There needs to be a primary oversight person [who] looks at the overall process.”
If a pharmacy wants to improve its <797> compliance, said Mr. Kastango, those who work there “should understand where they are relative to compliance—do a gap analysis.” Additionally, he said, “They should go to gemba,” using the Japanese term for going to the workplace and seeing what is done. An observer should “sit in the work area and watch what people are doing; observe people. … Visually audit whether people are following procedures.”
A consulting company, such as Mr. Kastango’s, can be of assistance. As a consultant to hospital pharmacies, he said, “I help them design <797>-compliant clean rooms, and help them to develop policies and procedures.” He also does audits when pharmacies want a third-party view.
Checklists can be useful for monitoring and improving performance. The infection preventionist and the pharmacist can partner to develop checklists. <797> has examples of checklists, but, “it’s very important that you tailor this to your specific situation. More important than just filling out checklists is to have a way to analyze the results and provide feedback to staff on compliance.” said Mr. St. John.
Mr. Kastango concluded, “You have to make sure people understand [infection control procedures] and that that understanding translates correctly into behaviors in the clean room.”
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