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assuring continuous complicance with joint commission standards a pharmacy guide

The 13-digit and 10-digit formats both work. Please try again.Please try again.Please try again. Used: GoodMay not include supplements.Something we hope you'll especially enjoy: FBA items qualify for FREE Shipping and Amazon Prime. Learn more about the program. The 8th Edition of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide, can help keep you up to speed. It’s the only book to cover all the latest major accreditation standards, including the Joint Commission. What’s more, the authors put this latest data into context with compliance strategies you can use in your everyday practice. Even More Easy-to-Use, Hands-On Tools This unique guideincludes a companion CD with more than 50 example forms and documents you can easily customize and put to use at your organization.Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. Register a free business account Pat currently serves as the V.P. of Quality and Regulatory Affairs for the Pharmacy Services business of Cardinal Health. As V.P. of Quality and Regulatory Affairs, Pat leads a team which provides assistance to organizations in preparing their pharmacies for accreditation surveys (e.g., The Joint Commission) and Centers for Medicare and Medicaid Services (CMS) and other regulatory surveys. The team focuses on processes that promote compliance with standards and regulations by providing resources such as accreditation preparedness assessments, medication safety assessments, operational assessments, regulatory assessments, licensing assistance, gap analysis tools, USP Chapter compliance tools, failure mode and effect analysis (FMEA) and root cause analysis (RCA) workshops, and a variety of other tools and educational programs. Pat has been a hospital pharmacist since 1972 and has over 35 years experience in the health care industry and in guiding pharmacies through more than 2000 regulatory and accreditation surveys.

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Pat is co-author of several publications including Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide, 7th edition. He is a contributing author to several other publications including the Handbook of Institutional Pharmacy Practice, 4th edition and Competence Assessment Tools for Health-System Pharmacies, 4th edition. Team members frequently present to national and state pharmacy groups on accreditation, regulatory, medication safety, and other related topics. Lee B. Murdaugh, RPh, PhD Dr. Murdaugh received a bachelor's degree in pharmacy and a doctorate in drug and materials toxicology from the University of Tennessee. While pursuing her doctorate, she was a fellow of the American Foundation for Pharmaceutical Education. She also completed a traineeship in acute care anticoagulation at Moses Cone Memorial Hospital and certification in asthma patient care at the University of Tennessee. She is currently a Director of Accreditation and Medication Safety for the Pharmacy Solutions business of Cardinal Health. Lee has over 27 years experience in the healthcare industry and in assisting more than 1000 hospitals in preparation for regulatory and accreditation surveys. Prior to joining Cardinal Health, she served as the Director of Pharmacy in a 535-bed tertiary care hospital. Dr. Murdaugh's practice interests are in the areas of medication safety, accreditation, regulatory compliance, and competence assessment. Lee is an author and contributing author to several ASHP publications and has also published in professional journals such as Hospital Pharmacy. She is a frequent speaker to national and state pharmacy professional organizations on accreditation, regulatory, medication safety, competence assessment, and other related topics. Patricia Clancy Kienle, RPh, MPA, FASHP Patricia Kienle is the Director of Accreditation and Medication Safety for Cardinal Health Pharmacy Solutions.

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She received her pharmacy degree from the Philadelphia College of Pharmacy and Science, and a Masters in Public Administration from Marywood University in Scranton, Pennsylvania. She completed an Executive Fellowship in Patient Safety from Virginia Commonwealth University and is an Adjunct Associate Professor at Wilkes University in Wilkes-Barre, Pennsylvania. She has served on the Board of Directors of the American Society of Health-System Pharmacists and as President of the Pennsylvania Society of Hospital Pharmacists. She is a Fellow of the American Society of Health-System Pharmacists, named Pharmacist of the Year by the PSHP, and the recipient of the Distinguished Achievement Award in Hospital and Institutional Practice from the American Pharmaceutical Association Academy of Pharmacy Practice and Management. She has served on the Pharmacotherapy Specialty Council of the Board of Pharmaceutical Specialties, as the pharmacist member of the Hospital Professional and Technical Advisory Committee of the Joint Commission and on the Board of Governors of the National Patient Safety Foundation. She is a frequent presenter to professional groups, with special interests in promoting medication safety, accreditation and regulatory issues in pharmacy and providing pharmacy services in integrated health systems. To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. The 8th edition of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide provides expert help in assuring that your pharmacy is compliant. The authors have helped hundreds of hospital pharmacies comply with Joint Commission standards and prepare for surveys.

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Benefit from their unique perspective in this latest edition of the indispensable guide to fostering high-quality patient care by incorporating Joint Commission standards into everyday practice. R2 users, please login or contact your administrator for more information. The new edition of Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide can help keep you on target with all standards and goals. What's more, the authors put this latest data into context with compliance strategies you can use in your everyday practice. If a Joint Commission survey finds that a hospital is not in compliance with a standard, the hospital receives a Requirement for Improvement (RFI). To avoid losing Joint Commission accreditation, the hospital must immediately address any RFI and submit evidence of standard compliance within 45 days. The CMS Hospital Conditions of Participation and interpretive guidelines should be read to ensure familiarity with the medication standards, because these are the basis of all elements in Joint Commission and state-led surveys. Medication storage is associated with the highest percentage of RFIs. The standard includes 13 different Elements of Performance, which can be grouped into three main areas: security, safety, and integrity. The security of pharmacologic agents is also mandated by federal standards. An Element of Performance added after the original 2004 MM Chapter addresses the security of a drug between the time it is dispensed and when it is administered to the patient. Written policies must define what constitutes security and list personnel with authorized access to medications. All controlled substances must be locked and other medications stored safely, with disposition by the end of each shift.

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Attention should also be paid to anesthesia kits, delivery to patient care and procedural units and other areas, and processes in which medications are not immediately placed into secure storage areas after being delivered by the pharmacy. The integrity of medications must be safeguarded, either by inspections and written logs, e.g., of storage temperatures, or by technologic means such as electronic logging systems. Joint Commission standards for medication orders are among the top-10 most challenging standards, and compliance is mandatory for Joint Commission accreditation. Because surveyors now use a tracer method of observation, orders are readily available for criticism. The 12 elements of performance for this standard require completeness, legibility, clear intent, and listing of special precautions when medications are ordered. Some hospitals require that orders include a written indication for use; however, each organization is responsible for defining what constitutes a complete order. A hospital must also establish a process for clarifying orders that are incomplete, illegible, or otherwise unclear. Legibility can be enhanced with pre-printed orders (see element 8 of the standard). Clear intent implies the inclusion of the indication for use, precise instructions for PRN specifications, range, titrating or tapering, and requirements for resuming therapy. Verbal orders must be authenticated within a prescribed time-frame (designated by the institution within state regulations), and staff members who are authorized to accept verbal orders must be clearly identified. Pediatric orders must be carefully written, especially for medications requiring weight-based dosing and calculations. Surveyors place particular emphasis on LASA medications, and each institution is responsible for developing a list of such drugs in the facility.

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The Joint Commission focus list can help in compiling such a list, and drugs associated with sentinel events or adverse outcomes should also be included. A policy for incomplete orders must be established and implemented. All orders must be complete, legible, and have clear intent for both indication and distribution of the drug. All pre-printed orders must be complete, and precautions for LASA medications must be clearly identified. This MM standard requires that all medication orders be evaluated by a pharmacist prior to administration of the first dose. The five Elements of Performance require that all orders are reviewed for appropriateness, interactions, complicating allergies, and contraindications before administration. Ensuring compliance with this standard involves not only pharmacists but also physicians, nurses, and other staff throughout the hospital. For this reason, the Joint Commission allows two exceptions to this standard. First, a licensed, independent practitioner (LIP) can take responsibility for the medication-use process. The scope of an LIP's responsibilities must be clearly defined. Second, in an urgent situation such as a cardiac arrest, when the benefit to the patient clearly outweighs potential risks, a patient may receive drugs prior to pharmacist review. Reviews may be performed by an offsite company or by another hospital. When the pharmacy re-opens, retrospective order reviews must be performed. A clarification to this standard permitted an LIP to control medications within the department, but the LIP had to be at the bedside. Because of the unique combination of acute and non-acute issues handled in the ED, new Interim Measures were published in 2007 to permit some allowances to this requirement. A hospital may now define LIP control within the individual institution. Instead of rigid adherence to rules, hospitals are expected to establish a system for control of medications in the ED.

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Further clarification of Interim Measures, and new Elements of Performance for review of medication orders in the ED are expected within the year. As with the ED, initially the radiology department was not considered distinct from the rest of the hospital and was required to adhere to the same standards as elsewhere in the hospital. In early 2007, an Interim Measure enabled an institution to define the radiologist's role within the department. Radiologists were given authority to develop protocols to define the role of a radiologist or LIP in managing medications in case of an emergency. The Joint Commission also created specific expectations for contrast agents. Currently, oral contrast can be distributed by authorized competent individuals within the radiology suite, provided this is done in compliance with the interim measures. New Elements of Performance for review of medication orders in Radiology are expected within the year. Compliance is mandatory whether an order is routine, after-hours, or from the ED, radiology department, or procedural areas such as the post-anesthesia care unit (PACU), dialysis unit or ambulatory surgery center. Interim measures and various allowances within the standard make compliance particularly challenging. A first step in improving medication safety is for a hospital to identify its high-alert drugs such as chemotherapy medications, narcotics, and anticoagulants. Anticoagulant safety will continue to be a focus for 2009, as well. Changes to interim measures for the ED and radiology suite are also expected. Other proposed NPSGs for 2009 focus on transfusion care and nosocomial infectious agents such as methicillin-resistant Stapholococcus aureus (MRSA) and clostridium. In addition, the Joint Commission has embarked on a Standards Improvement Initiative. Several chapters, including Medication Management, are expected to be renumbered for 2009.

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Because medication storage was deficient in almost half of hospitals surveyed, the Joint Commission is likely to continue its emphasis in this area. Familiarity with each standard's elements of performance and with CMS Conditions of Participation and interpretive guidelines will help prepare for hospital compliance. Particular attention should be paid to exceptions such as those that allow LIPs to control medications so long as a hospital has developed clear policies regarding appropriate procedures and personnel. Most importantly, compliance with both Joint Commission MM standards and CMS Conditions of Participation improves the safety and quality of every stage of medication use. The Center works with nationally and internationally recognized thought leaders to create conferences, educational programs, working groups, publications, web-based programming and industry initiatives that can help clinicians and administrators continuously improve the safety, quality of care, and financial performance of their institutions. She received her pharmacy degree from the Philadelphia College of Pharmacy and Science, and a master's degree in public administration from Marywood University in Scranton, Pennsylvania. She completed an Executive Fellowship in Patient Safety from Virginia Commonwealth University and is an adjunct associate professor at Wilkes University in Wilkes-Barre, Pennsylvania. She also has served on the Pharmacotherapy Specialty Council of the Board of Pharmaceutical Specialties, as the pharmacist member of the Hospital Professional and Technical Advisory Committee of the Joint Commission and on the Board of Governors of the National Patient Safety Foundation.Uselton leads the Quality and Regulatory Affairs team, which provides assistance to organizations in preparing for Joint Commission, Centers for Medicare and Medicaid Services (CMS), and other accreditation and regulatory surveys.

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Their focus is on processes that promote patient safety and the identification and implementation of best practices. Prior to joining Cardinal Health in 1992, Uselton served as the director of operational audit for a hospital management firm.Medscape Medical News, Available at. Pharmacotherapy, 26 (5), 601-608. Available at Available at. With JCI as your partner, you will benefit from our decades of expertise.From standards manuals and survey process guides to e-books and periodicals, we offer a one-stop shop for learning. Whatever your goals, we have all the tools you need. He has consulted as an expert witness in dozens of cases, including numerous pharmacy policyrelated cases. Dr. Vogenberg is Principal at the Institute for Integrated Healthcare and National Institute of Collaborative Healthcare in Greenville, South Carolina, and Adjunct Professor of Pharmacy Administration at the University of Rhode Island, College of Pharmacy, in Kingston, Rhode Island. This article has been cited by other articles in PMC. At that time, Vogenberg and Gomes 3 described market and regulatory changes that were causing care delivery models to evolve, merge, or change from their origins. The Joint Commission, the American Medical Association, and all of pharmacy’s professional societies have promoted sound drug formulary systems, solid medication use policies, and best practices for hospital and health-system pharmacies. Beyond licensing pharmacists, the pharmacy profession, like many others, establishes standards of practice in accordance with federal and state law. These standards include developing policies and procedures around medication management, use, dispensing, monitoring, evaluating, responding to potential adverse events and medication errors, and assessing medication management systems for risk to patients in order to improve safety, among other elements.

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5 A variety of system failures can relate to medication use, some as simple as a pharmacy technician signing an order form as a pharmacist to procure drugs. In a closed case, Banks v Regions Hospital, the technician filled out an order form to initiate a free trial program with a pharmaceutical manufacturer so the hospital would receive drugs for its patients. A court found that this constituted employment misconduct. However, whether a pharmacist’s signature is necessary for product acquisition can be debated. The permitted role of a technician or a pharmacist can be based on hospital policy rather than laws or rules, according to the court. The case involved a middle-aged woman who was screened and pre admitted for thyroidectomy surgery. As part of the preadmission process, methylene blue dye was ordered to help the surgeon visualize the thyroid and parathyroid gland structures—a common use of the dye. 8 The patient’s home medication history included venlafaxine (Effexor, Pfizer). The hospital pharmacy prepared an intravenous (IV) methylene blue infusion (500 mg in 500 mL normal saline), which was administered one hour before surgery. Following surgery, the patient did not wake up; she experienced blood pressure swings and clonic seizures. Subsequently, she was admitted to the intensive care unit with a diagnosis of serotonin syndrome, most likely caused by the interaction of methylene blue and venlafaxine. Coma was induced and maintained for three weeks. The comatose patient was transferred to a university hospital, where she recovered with significant neurological deficits. She returned to work three months later at a much lower cognitive function and retired early due to cognitive problems. The patient sued the surgeon and the hospital for administering the dangerous combination of methylene blue and venlafaxine.

Medication reconciliation had been performed upon admission, but the pharmacist testified that the hospital’s pharmacists did not usually consider home medications, nor did the hospital and pharmacy software screen home medications against new medication orders, so this was not done automatically. The pharmacist testified that methylene blue orders were received a few times a year using a preprinted order set. The pharmacist also testified that because she was not familiar with methylene blue, she checked the package insert and found no warnings about interactions between venlafaxine and the dye. She did not, however, check the venlafaxine package insert (which contraindicates the methylene blue combination), nor did she check any external drug interaction software— such as Drugs.com, which clearly identifies the combination interaction risk as “major” (in red text) and indicates that coadministration is contraindicated. 9 As part of experts’ case review, a search and analysis of the Food and Drug Administration (FDA) MedWatch database was conducted by FDAble in November 2016 for methylene blue, interaction medications, and adverse events. 10 Serotonin syndrome is the most commonly reported adverse reaction when methylene blue is reported as a suspect or interacting medication in an adverse event case ( Figure 1 ). Specifically, 43.7 of cases (199 of 455) that reported methylene blue also reported serotonin syndrome. The hospital’s policy and procedure described a screening duty, as does the American Society of Health-System Pharmacists’ Practice Guidelines. 11 The pharmacist also agreed that there was a duty to screen—but she blamed the oversight (and thus the life-threatening interaction) on the absence of the warning in the methylene blue package insert. Based on this testimony, attorneys for the injured patient sued Akorn, the manufacturer of the methylene blue injection that was used in the case.

Akorn admitted knowledge of the interaction, but claimed that since methylene blue was a grandfathered drug and not the subject of a “new drug application,” Akorn was not able to include the interaction warning about serotonin syndrome with selective serotonin reuptake inhibitors. A different manufacturer of methylene blue, American Regent, did provide the warning in its package insert for the product, even before it was awarded an NDA for methylene blue. The hospital, its pharmacy, the pharmacist, and the surgeon were dismissed from the case before the trial, which was conducted with Akorn as the only defendant. Akorn maintained its position that it could not warn and blamed the pharmacist for not warning the surgeon and avoiding the drug interaction injury. An FDA labeling expert testified that Akorn had a duty to include the warning and could have done so. Following the injury, home medication screening was added to the software-driven drug-interaction screening. While the jury attributed no fault to the pharmacist or the surgeon in the post-verdict jury poll, the result could have been very different if the correctly labeled American Regent product had been used. In addition, this case could have triggered a continuous survey by The Joint Commission, exposing the organization and its employees to loss of accreditation. Professionally, such a case contains many moral and ethical issues for today’s larger, more complex organizations. For example, is it an employed person’s responsibility as a health care professional to take on what could be perceived as an unnecessary action based on the starting facts of the case. Can a health care professional rely on his or her organizational structure to provide a level of due diligence that addresses core patient care values at the level of any individual case. What standard of care can a patient expect in an accredited organization on any given day, time, or circumstance.

What professional duty does a physician or pharmacist have to themselves, to their co-workers, and to patients on each encounter or care activity. The question becomes: How does such a committee work within the modern health care delivery organization. In advance of such defensive positions and a potential downward spiral in patient treatment, care delivery organizations have a chance to address the situation with positive steps. REFERENCES 1. Balu S, O’Connor P, Vogenberg FR. Chapter 12: Pharmacy and therapeutics committee. In: Malone PM, Kier KL, Stanovich JE, Malone MJ, editors. App LEXIS 1027. November 9, 2015 7. Ann Pope and Anthony Pope v Horatio V. Cabasares et al, No. 22015V048780, Houston County, Georgia. 8. Kuriloff DB, Sanborn KV. Rapid intraoperative localization of parathyroid glands utilizing methylene blue infusion. ASHP Council on Pharmacy Practice. ASHP statement on the pharmacist’s role in medication reconciliation. Your comment will be reviewed and published at the journal's discretion. Please check for further notifications by email.It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. All content is available on the global site. Specialized in clinical effectiveness, learning, research and safety. With workflows optimized by technology and guided by deep domain expertise, we help organizations grow, manage, and protect their businesses and their client’s businesses. We specialize in unifying and optimizing processes to deliver a real-time and accurate view of your financial position. We streamline legal and regulatory research, analysis, and workflows to drive value to organizations, ensuring more transparent, just and safe societies. The Joint Commission is the nation's oldest and largest standards-setting and accrediting body in health care. Facilities eligible for accreditation include: All regular Joint Commission accreditation surveys are unannounced.

During the survey, they select patients randomly and use their medical records as a roadmap to evaluate standards compliance. As surveyors trace a patient’s experience in a health care organization, they observe the doctors, nurses, and other staff providing care, and often speak to the patients themselves. Every three months, hospitals submit data to the Joint Commission on how they treat specific conditions, such as heart attack care or pneumonia. The data is available to the public and updated quarterly on www.qualitycheck.org. Throughout the accreditation cycle, organizations are provided with a self-assessment scoring tool to help monitor their ongoing standards compliance. Joint Commission accreditation is woven into the fabric of a health care organization’s operations. The Joint Commission’s standards and emphasis on clinical practice guidelines help organizations establish a consistent approach to care, reducing the risk of error. This helps to maintain a consistently high level of quality, using effective data-driven performance improvement. They are trained to provide expert advice and education on good practices during the on-site review. Achieving certification provides the clinical team with common goals and a concrete validation of their combined efforts. Certified organizations proudly display the Gold Seal to advertise their commitment to health care quality. Certification may meet certain regulatory requirements in some states, which can reduce duplication. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards. Click HERE to learn more about how these robust courses can help you increase clinical competency and stay in compliance with national guidelines! Learn More How many nurse educators can attest to doing the same.

The process is applicable to any practice setting where pharmacists provide patient care and for any patient care service provided by pharmacists. Pharmacists’ Patient Care Process.Information may be gathered and verified from multiple sources, including existing patient records, the patient, and other health care professionals. This process includes collecting: This process includes assessing: This process includes establishing a care plan that: During the process of implementing the care plan, the pharmacist: This process includes the continuous monitoring and evaluation of: You will also receive an email with a direct link to the resource and usage permission instructions. This website works best with modern browsers such as the latest versions of Chrome, Firefox, Safari, and Edge. If you continue with this browser, you may see unexpected results.Here you will find resources, by no means exhaustive, on pharmacy management, accreditation and standards, pharmacoeconomics, and business practices. Following some tips can ensure both Pharmacy's compliance and a successful outcome. Standards fall primarily into 2 categories: improving quality and decreasing adverse outcomes. Furthermore, all JCAHO standards and their related chapters address 1 of 3 major functions (Table 1 2 ). Now, follow these 10 tips. JCAHO surveyors also monitor compliance with applicable state laws and regulations, so review state requirements. Initiated in 2003, these goals specify patient-safety priorities, and some change annually. Of the goals for 2004, 3 are clearly pharmacy priorities: Standardize abbreviations, acronyms, and symbols used throughout the organization.) Standardize and limit the number of drug concentrations available in the organization.) Ensuring compliance is time-consuming and requires extensive multidisciplinary collaboration. Establish a circular, continuous quality-improvement process.

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assuring continuous complicance with joint commission standards a pharmacy guide