Nov 29, 2008 a suggested stepbystep methodology for usp 797 compliance is as follows. Our experienced inhouse engineers will help you meet the quality standards for compounded sterile preparation csp and assist you in selecting the right components and features to fit your needs. Jcaho touches on usp 797, reconciliation during survey prepare your staff for a wide range of questions be prepared for surveyors to watch staff prepare ivs to check your hospitals compliance with u. Not every organization may need to build a tworoom clean area to comply. The result is decreased patient safety, delayed start times, staff inefficiency, and noncompliance with joint commission requirements. Usp 797 is the first enforceable standard 20060601. General chapter 797, pharmaceutical compounding sterile preparations usp, the latest version of which was issued in 2008. Failure to complete this addendum within the month of march or within 30 days of. This section summaries how we obtain, store and use information about you. Jcaho began surveying for compliance with usp 797 on july 1, 2004, so efforts to comply with usp 797 should have begun andor must begin immediately. So far no inspections have occurred that we are aware of regarding usp compliance. Users should understand, however, that the action plans generated in areas of noncompliance are correct but do not reflect criticalpoints most current best practices. About usp usp chapter describes the conditions, practices and quality standards for compounded sterile preparations csps of drugs and nutrients.
Usp 797800 compliance click to enlarge in 2005, usp 797 will require these are regulations, not guidelines a cleaner environment for health care institutions, pharmacies, physicians practice facilities and other facilities where compounded sterile preparations are prepared, stored and dispensed. Wolters kluwer expands simplifi 797 functionality to create a. Jun 17, 2017 usp 797 compounding compliance update. Certainly best practice models always include the need for detailed written sops, which must act as the basis of all staff training. The joint commission on accreditation of healthcare organizations jcaho has. Commentary usp general chapter 797 pharmaceutical compounding. This news release indicated that the jcaho was surveying compliance with 797 as of the same date of the web announcement 4. The purpose of usp chapter pharmaceutical compounding is to provide standards for the protection and safety of patients and healthcare workers involved in sterile compounding preparations such as pharmacists, nurses, physicians and pharmacy technicians by reducing the potential for microbial contamination caused by an unclean. Need to prove compliance with fda gxp aaalac cap clia haccp jcaho usp 797 constant need to manage false alarms significant time spent manually recording data or creating reports for regulatory compliance and audit purposes. Pharmacopeia usp chapter 797 on compounding sterile preparations. May 01, 2004 the jcaho will consider organizations in compliance for 2004 if they have plans in place to meet the usp requirements.
Following years of patient safety recommendations and professional guidelines, the intent of usp 797 is to lay out. Shares knowledge gained to help advance pharmacy safety published. We leverage 30 years of experience in safeguarding life science assets and equipment. Pharmacy onesource acquires schedulerx application from. The purpose of usp chapter 797 pharmaceutical compounding is to provide standards for the protection and safety of patients and healthcare workers involved in sterile compounding preparations such as pharmacists, nurses, physicians and pharmacy technicians by reducing the potential for microbial contamination caused by an unclean. Following normal survey procedure, citations issued at the standardlevel may, depending on the manner and degree of noncompliance identified, also result in a conditionlevel citation. The joint commissions medication management mm standards and. The gap analysis for the current usp, and are available now in microsoft word.
Needs assessments, gap analyses, and recommendations for ensuring compliance with usp chapter 797 sterile compounding hazardous and nonhazardous. Pharmacies failing to comply with usp 797 risk exposure to patient lawsuits as well as the potential loss of the joint commissions jcaho accreditation. It is intended to provide a very general overview only. Usp requires a designated person to take a leadership role and responsibility for adhering to the standard, including implementing procedures, monitoring and maintaining reports of testing and sampling, and a list of hazardous drugs used. Jul 30, 2008 pharmacies failing to comply with usp 797 risk exposure to patient lawsuits as well as the potential loss of the joint commissions jcaho accreditation. Usp 797 defines a cleanroom as a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Usp 797 is designed to protect patients and pharmacists. Kate douglass, president of performance strategies, is a coauthor of criticalpoints usp gap analysis tool and codirector of the 2011 usp compliance study.
Representatives of the joint commission on accreditation of healthcare organizations jcaho answer questions about new jcaho survey procedures designed to assess compliance with united states pharmacopeia usp chapter. Our customers mange 340b, usp, urac and joint commission compliance with. Wolters kluwer, a leading global provider of information and point of care solutions for the healthcare industry, announced today the further expansion of functionality within simplifi 797, creating a turnkey usp 800 solution that addresses important employee education and safety needs to ensure safe compounding of hazardous drugs. Use new delays to catch up to more stringent usp requirements. The survey looks at various areas of usp 797 compliance. Usp general chapter pharmaceutical compoundingsterile. Results jcaho compliance healthcare control systems. An overview of usp chapter 797 prepared by pharmacist mike hurst, rph, mba, for pharmacy supplier baxa corp. Xiltrix north america was established to make life sciences safer and more predictable through technology. The joint commission tjc has said it will continue to survey. Washington law holds the responsible manager and all pharmacists on duty responsible for ensuring pharmacy compliance with all state and federal laws governing the practice of pharmacy. Jun 01, 2006 an overview of usp chapter 797 prepared by pharmacist mike hurst, rph, mba, for pharmacy supplier baxa corp.
Jcaho touches on usp 797, reconciliation during survey. One factor for compliance with usp 797 is a reliable system to track its many facets. Healthcare organizations jcaho posted an announcement titled compliance with new uspnf chapter on compounding sterile preparations on the web site of the joint commission resources, an af. Usp chapter and chapter describe minimum acceptable sterile compounding practice and contains many specific references to the requirement for written sops. The jcaho will consider organizations in compliance for 2004 if they have plans in place to meet the usp requirements. It improves the health and wellbeing of our patients and 2. One area of the survey data highlighted usp requirements for usp compliance. Some notes reflect legal requirements, previous joint com. The joint commission actively enforces usp chapter 797 compliance as required.
Usp 797 is an important publication issued by the united states pharmacopeia. Included among usps standards are those related to the practice and quality standards for compounded sterile preparations, usp 797. Wa pharmacy quality assurance commission 2020 responsible. Downloadable documents for compliance use these documents to aid in compliance with standards, whether state boards of pharmacy, usp or fda. Braun medical educates pharmacists concerning jcaho guideline usp 797. Janfeb 2005 sterile preparations view all articles in issue. Needs assessments, gap analyses, and recommendations for ensuring compliance with usp chapter sterile compounding hazardous and nonhazardous. Pharmacy stars enterprise pharmacy quality management system. With regulation enforcement and discussion becoming more and more prevalent, many facilities are now conducting an annual gap analysis of their usp compliance. Usp 797 800 compliance click to enlarge in 2005, usp 797 will require these are regulations, not guidelines a cleaner environment for health care institutions, pharmacies, physicians practice facilities and other facilities where compounded sterile preparations are prepared, stored and dispensed. What is usp 797 and how to stay compliant pharmacy onesource. Usp 797 is the first enforceable standard 20060601 ahc. Usp contains 18 sections and bridges multiple departments and cost centers.
Organizations may not pick from both the 2008 and 2019 usp 797 versions. Sterile medication compounding update for hospital accreditation. The joint commission on accreditation of healthcare organizations jcaho has stated that healthcare organizations can expect to be surveyed for compliance with usp 797. Dream come true has made over 250 dreams come true in western connecticut for terminally ill children diagnosed with a range of chronic and terminal illnesses including childhood cancers, genetic illnesses, complications from birth trauma, and more. We added a new standardlevel tag to allow surveyors. Pharmacopoeia, and its jcahomandated schedule for implementation. As the article notes, even though usp is legally enforceable and the industry standard despite state legislation, less than half of state regulations specifically reference usp for sterile compounding. The tv2 monitor belongs to you and although the logged data can certainly be copied to any computer on the same network, or even the cloud, it does not cost you any. If youd like to view the articles from the 2018 usp 797 and 800 compliance study, you can access it. The firm has been on the vanguard of understanding and implementing the usp 797 guidelines since 2005, and the draft and now final usp 800.
The usp 800 gap tool continues to measure compliance with the original version of the chapter published in 2016 and is an accurate measure of compliance. Data from these tools were published annually from 2011 through 2018. He also consults with pharmacies engaging in sterile and nonsterile compounding, including hazardous drugs. Usp 797 compliance with usp 797 is our duty because.
Jcaho medication management and usp 797 compliance, clinical documentation, financial performance, communications, formulary management, clinical decisions and patient safety. May 26, 2006 our applications address challenges with. Enterprise software that doesnt waste your time on repetitive tasks. Engineering controls for compliance with usp chapters counts to be taken during operations particle size usp 0. Mecart guarantees its cleanroom facilities compliance with local and national requirements, such as usp 797 and usp 800. Following years of patient safety recommendations and professional guidelines, the intent of usp 797 is to lay out procedural. To reduce the chance of contamination during the compounding and packaging of these products, compounding pharmacists must now perform critical operations in a cleanroom. There was a dip in complian ce in 2017, but 2018 data shows facilities are back on track with regulation enforcement and discussion becoming more and more prevalent, many facilities are now conducting an annual gap analysis of their usp compliance. The gap analysis for the current usp, 797 and are available now in microsoft word. For instance, under usp, one new and more stringent. Evaluate specific highrisk medication management processes compounding. The joint commission surveys to the principles of the usp chapters. Surveyors will help educate organizations about the requirements if they are unaware of them at survey time, according to the jcaho.
Michael freudiger is a boardcertified clinical pharmacist and usp chapter compliance supervisor at saint agnes medical center in fresno, calif. Our experienced inhouse engineers will help you meet the quality standards for compounded sterile preparation csp and assist you in selecting the. Usp 795 and usp 797 compliance are not as frequently talked about recently, yet they are as important as ever. May 01, 2005 jcaho touches on usp 797, reconciliation during survey prepare your staff for a wide range of questions be prepared for surveyors to watch staff prepare ivs to check your hospitals compliance with u. Analysis of state required compliance with usp compounding standards state specifically requires compliance with usp standards for board developed rules similar to or reference usp standards notes vt no va yes wa no wv yes wi yes wy yes important state regulations and rules are changing constantly. The notes are compliance expectations and suggestions that are based on the authors personal experiences, reports from surveyed organizations, and surveyors statements. Jcaho to survey for sterile compounding compliance. There was a dip in complian ce in 2017, but 2018 data shows facilities are back on track.
Braun medical educates pharmacists concerning jcaho. In the april 2004 issue of its perspectives publication, the joint commission on accreditation of healthcare organizations announced it would begin in july to survey compliance with the new chapter in the 2004 united states pharmacopeia national formulary uspnf, titled usp tests and assays. At this location, you may register for and access the criticalpoint usp 797 and 800 electronic gap tools. It is now five years since the new england compounding center necc tragedy brought compounding specialty pharmacies to the attention of the media and the us public. A suggested stepbystep methodology for usp 797 compliance is as follows. As the article notes, even though usp 797 is legally enforceable and the industry standard despite state legislation, less than half of state regulations specifically reference usp 797 for sterile compounding. Laboratory monitoring system xiltrix north america. Kate has been a module author for criticalpoints sterile compounding webbased training and has written several articles on sterile compounding quality and training. Usp 797 is considered a standard of practice and as such can be adopted and enforced by the fda, local state boards of pharmacy, and accreditation organizations.
Usp 797800 compliance pharmaceutical compounding nci. Through a series of written guidelines, usp 797 regulates the personnel. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class. These tools can help build the foundation for a corrective action plan that details the activities and resources needed to comply with usp compounding requirements. Microtests launch of the new services, and its free audit offer, are timed with moves by the fda to prompt more pharmacies to achieve usp 797 compliance. Pestle is a compliance management software platform for sterile and nonsterile pharmacies that guides and helps you document your pharmacys compliance activity to meet the requirements of usp 795, 797 and 800. How software can help you follow usp 797 guidelines. Surveyors asked staff at the medical center in bowling green, ky, about the risk level of the ivs they. Microtests launch of the new services, and its free audit offer, are timed with moves by the fda. Jcaho medication management and usp 797 compliance, clinical documentation, financial performance, communications, formulary management, clinical decisions and improving patient. Blueprint for implementing chapter 797 for compounding.
747 182 951 1347 310 683 1024 346 1042 1011 1314 656 370 969 815 830 251 851 477 1425 839 645 89 945 576 790 229 491 265 1058 816 653 76 1361 677 259 76 1246 1125 1347