Joint Commission International A division of Joint Commission Resources, Inc. The mission of Joint Commission International is to improve the quality of care in the international community through the provision of accreditation and consultation services. Joint Commission Resources educational programs and publications support, but are separate from, the accreditation activities of Joint Commission International. Attendees at Joint Commission Resources educational programs and purchasers of Joint Commission Resources publications receive no special consideration or treatment in, or confidential information about, the accreditation process. © 2007 by Joint Commission International All rights reserved. No part of this publication may be reproduced in any form or by any means without written permission from the publisher. Printed in the U.S.A. 5 4 3 2 1 Requests for permission to make copies of any part of this work should be mailed to Permissions Editor Department of Publications Joint Commission Resources One Renaissance Boulevard Oakbrook Terrace, Illinois 60181 U.S.A. permissions@jcrinc.com ISBN: 978-1-59940-141-6 Library of Congress Control Number: 2007928871 For more information on Joint Commission International, please visit http://www.jointcommissioninternational.com Contents Foreword v Introduction 1 Joint Commission International Accreditation Policies 5 Table of Changes 21 International Patient Safety Goals 31 Functional Chapters Section I: Patient-Centered Standards 37 Access to Care and Continuity of Care 39 Patient and Family Rights 53 Assessment of Patients 71 Care of Patients 95 Anesthesia and Surgical Care 107 Medication Management and Use 117 Patient and Family Education 131 Section II: Health Care Organization Management Standards 137 Quality Improvement and Patient Safety 139 Prevention and Control of Infections 155 Governance, Leadership, and Direction 167 Facility Management and Safety 181 Staff Qualifications and Education 195 Management of Communication and Information 213 Glossary 229 Index 241 Foreword Joint Commission International (JCI) is very pleased to present this third edition of the International Standards for Hospitals. JCI was created in 1998 as the international arm of The Joint Commission (United States), and this new edition of the standards reaffirms JCI’s mission to improve the safety and quality of patient care around the world. JCI standards are truly international in their development and revision. The process of developing standards is actively overseen by an expert international task force, whose members are drawn from each of the world’s populated continents. In addition, the standards were evaluated by individuals around the world via an Internet-based field review, as well as considered by JCI Regional Advisory Councils in Asia Pacific, Europe, and the Middle East, and other experts from various health care fields. This new edition of the hospital standards joins the suite of JCI international standards related to Ambulatory Care, the Care Continuum, Clinical Laboratories, Medical Transport, and those for the Certification of Disease- or Condition-Specific Programs. JCI standards are the basis for accreditation and certification of individual health care facilities and programs around the world. In addition, JCI standards have been used to develop and establish accreditation programs in many countries and have been used by public agencies, health ministries, and others seeking to evaluate and improve the safety and quality of patient care. This third edition reflects the dynamic changes occurring around the globe in health care. New technologies and treatments are in use; patients are traveling beyond borders to receive health care; physicians, nurses, and allied health professionals are moving across borders to seek better opportunities; and health care workers are faced with exposure to biological and other hazards. Each day, health care facilities serve as the training grounds for many students in the health professions, infectious agents are spreading rapidly across the globe, adverse health care errors continue to occur, and the number and variety of ethical and legal challenges to the delivery of health care continue to grow. This third edition of the hospital standards addresses these and other issues with new and revised standards, including a new chapter focused on the International Patient Safety Goals, new accreditation decision rules, and revised accreditation policies. Many of these changes are identified in the table found on pages 21–30. As with all JCI standards, this edition contains the complete set of standards, statements of intent for each standard, and measurable elements for assessing compliance with each standard. This structure will permit readers to identify and understand the specific requirements embodied in the standards. For further information on the hospital and other accreditation and certification programs of JCI, the JCI International Patient Safety Goals, and other JCI initiatives, or assistance in developing a country-specific accreditation program, or support in preparing for accreditation, please contact us at Joint Commission International Accreditation 1515 West 22nd Street, Suite 1300W Oak Brook, IL 60523 USA 01-630-268-7400 JCIAccreditation@jcrinc.com JCI well understands that standards are continually a “work in progress.” In that spirit, we welcome comments and suggestions for improvement. Karen Timmons President and CEO Joint Commission International and Joint Commission Resources Introduction This third edition of the Joint Commission International (JCI) Accreditation Standards for Hospitals contains all the standards, intent statements, measurable elements of standards, accreditation policies and procedures, and a glossary of key terms. This introduction is designed to provide you with information on the following topics: The benefits of accreditation JCI and its relationship to The Joint Commission (USA) The international accreditation initiative of JCI The origin of the standards and how they are organized How to use this standards manual Special features of this manual If, after reading this publication, you have questions about the standards or the accreditation process, please contact JCI. Contact information is located in the Foreword (preceding this section). What is accreditation? Accreditation is a process in which an entity, separate and distinct from the health care organization, usually nongovernmental, assesses the health care organization to determine if it meets a set of requirements (standards) designed to improve the safety and quality of care. Accreditation is usually voluntary. Accreditation standards are usually regarded as optimal and achievable. Accreditation provides a visible commitment by an organization to improve the safety and quality of patient care, ensure a safe care environment, and continually work to reduce risks to patients and staff. Accreditation has gained worldwide attention as an effective quality evaluation and management tool. What are the benefits of accreditation? The accreditation process is designed to create a culture of safety and quality within an organization that strives to continually improve patient care processes and results. In doing so, organizations improve public trust that the organization is concerned for patient safety and the quality of care; provide a safe and efficient work environment that contributes to worker satisfaction; negotiate with sources of payment for care with data on the quality of care; listen to patients and their families, respect their rights, and involve them in the care process as partners; create a culture that is open to learning from the timely reporting of adverse events and safety concerns; and establish collaborative leadership that sets priorities for and continuous leadership for quality and patient safety at all levels. What is JCI accreditation, and what is JCI’s relationship to The Joint Commission? JCI is the international arm of The Joint Commission (USA); JCI’s mission is to improve the quality of health care in the international community. For more than 75 years, The Joint Commission (USA) and its predecessor organization have been dedicated to improving the quality and safety of health care services. Today, The Joint Commission is the largest accreditor of health care organizations in the United States—it surveys nearly 16,000 health care programs through a voluntary accreditation process. The Joint Commission and JCI are both nongovernmental, not-for-profit USA corporations. What are the purpose and the goal of JCI accreditation initiatives? JCI accreditation is a variety of initiatives designed to respond to a growing demand around the world for standards-based evaluation in health care. The purpose is to offer the international community standards-based, objective processes for evaluating health care organizations. The goal of the program is to stimulate demonstration of continuous, sustained improvement in health care organizations by applying international consensus standards, International Patient Safety Goals, and indicator measurement support. In addition to the standards for acute care hospitals contained in this third edition, JCI has developed standards and accreditation programs for: Clinical Laboratories The Care Continuum (home care, assisted living, long-term care, hospice care) Medical Transport Organizations Ambulatory Care JCI also offers certification of programs that provide Disease or Condition-Specific Care such as programs for stroke care or cardiac care. JCI accreditation programs are based on an international framework of standards adaptable to local needs. The programs are characterized by: International consensus standards, developed and maintained by an international task force, and approved by an international Board, are the basis of the accreditation program. The underlying philosophy of the standards is based on principles of quality management and continuous quality improvement. The accreditation process is designed to accommodate the legal, religious, and/or cultural factors within a country. Although the standards set uniform, high expectations for the safety and quality of patient care, country-specific considerations related to compliance with those expectations are part of the accreditation process. The on-site survey team and agenda will vary depending on the organization’s size and type of services provided. For example, a large teaching hospital may require a four-day survey by a physician, a nurse, and an administrator, while a smaller regional or community hospital may require a two- or three-day survey. Similarly, a clinical laboratory may require one person for only two days depending on the number of specialty tests provided and performed. JCI accreditation is designed to be valid, reliable and objective. Based on the analysis of the survey findings, final accreditation decisions are made by an international accreditation committee. How were the hospital standards initially developed and how were they refined for this third edition? A 16-member international task force, composed of experienced physicians, nurses, administrators, and public policy experts, guides the development and revision process of the JCI international accreditation standards. The task force consists of members from six major world regions: Latin America and the Caribbean, Asia and the Pacific Rim, the Middle East, Central and Eastern Europe, Western Europe, and Africa. The work of the task force is refined based on an international field review of the standards and the input from experts and others with unique content knowledge. An international standards committee continues the work of the task force and makes recommendations about updates and modifications necessary for these standards to continually reflect contemporary practice. How are the standards organized? The standards are organized around the important functions common to all health care organizations. The functional organization of standards is now the most widely used around the world and has been validated by scientific study, testing and application. The standards are grouped by those functions related to providing patient care and those related to providing a safe, effective, and well-managed organization. These functions apply to the entire organization as well as to each department, unit, or service within the organization. The survey process gathers standards compliance information throughout the entire organization and the accreditation decision is based on the overall level of compliance found throughout the entire organization. Why are there no standards in bold typeface in this third edition? In previous editions, some standards were in bold typeface as they were considered “core,” because they protect fundamental patient and family rights, support a safe patient care facility, and reduce risk in the patient care process. Experience has shown that all of the standards are related equally to reducing risk in health care organizations and thus all standards are considered equal in importance in meeting the accreditation decision rules. Are the standards available for the international community to use? Yes. These standards are available in the international public domain for use by individual health care organizations and by public agencies in improving the quality of patient care. The standards only can be downloaded at no cost from the JCI website for consideration of adapting them to the needs of individual countries. The translation and use of the standards as published by JCI requires permission. When there are national or local laws related to a standard, what applies? When standard compliance is related to a law or regulation, whichever sets the higher or stricter requirement applies. How do I use this standards manual? This international standards manual can be used to guide the efficient and effective management of a health care organization; guide the organization and delivery of patient care services, and efforts to improve the quality and efficiency of those services; review the important functions of a health care organization; become aware of those standards that all organizations must meet to be accredited by JCI; review the compliance expectations of standards and the additional requirements found in associated intent statements; become aware of the accreditation policies and procedures and the accreditation process; and become familiar with the terminology used in the manual. What are the “measurable elements” of a standard? The measurable elements of a standard are those requirements of the standard and its intent statement that will be reviewed and assigned a score during the accreditation survey process. The measurable elements simply list what is required to be in full compliance with the standard. Each element is already reflected in the standard or intent statement. Listing the measurable elements is intended to provide greater clarity to the standards and help organizations educate staff about the standards and prepare for the accreditation survey. How frequently will the standards be updated? Information and experience related to the standards will be gathered on an ongoing basis. If a standard no longer reflects contemporary health care practice, commonly available technology, quality management practices, and so forth, it will be revised or deleted. It is currently anticipated that the standards will be revised and published at least every three years. What is new in this third edition of the manual? A full listing of all the changes from the second edition to this third edition of the standards can be found on pages 21-30. Some of the most significant changes include the following:    A baseline assessment of international standards compliance Education by the surveyor, as appropriate The three topics evaluated with individual-based system tracers are data use, infection prevention and control, and medication management, although the number of individual-based system tracers varies based on the length of the survey. Despite survey length, the data use individual-based system tracer is always performed. Data use. The data use individual-based system tracer focuses on how a hospital collects, analyzes, interprets, and uses data to improve patient safety and care. Infection prevention and control. The infection prevention and control individual-based system tracer explores your hospital’s infection prevention and control processes. The goals of this session are to assess a hospital’s compliance with the relevant “Prevention and Control of Infections” (PCI) standards, identify infection prevention and control issues that require further exploration, and determine actions that may be necessary to address any identified risks and improve patient safety. Medication management. The medication management individual-based system tracer explores a hospital’s medication management processes while focusing on sub processes and potential risk points (such as hand-over points). This tracer activity helps the surveyor(s) evaluate the continuity of medication management from procurement of medication through the monitoring (also see Glossary) of their effects on patients. The Role of Staff in Tracer Methodology Staff will be asked to provide the surveyor(s) with a list of active patients, including the patients’ names, current locations in the hospital, and diagnoses, as appropriate. The surveyor(s) may request assistance from hospital staff for selection of appropriate tracer patients. As the surveyor(s) moves around a hospital, he or she will converse with a wide variety of staff involved in the tracer patient’s care, treatment or services. This could include nurses, physicians, therapists, case managers, aides, pharmacy and lab personnel, and support staff. If those staff members are not available, the surveyor(s) will ask to speak to another staff member who would perform the same function(s) as the member who has cared for or is caring for the tracer patient. Although it is preferable to speak with the direct care giver, it is not mandatory because the questions that will be asked are questions that any caregiver should be able to answer in providing care to the patient being traced. JCI Sentinel Event Policy Sentinel Events In support of its mission to improve the safety and quality of health care provided to the international community, JCI reviews organization activities in response to sentinel events (also see Glossary) in its accreditation process. This includes all initial accreditation surveys, triennial accreditation surveys and, as appropriate, focused surveys. The following apply: A sentinel event is an unanticipated occurrence involving death or major permanent loss of function unrelated to the natural course of the patient’s illness or underlying condition. A sentinel event may occur due to wrong-site, wrong-procedure, wrong-patient surgery. Such events are called “sentinel” because they signal a need for immediate investigation and response. The terms “sentinel event” and “medical error” are not synonymous; not all sentinel events occur because of an error and not all errors result in sentinel events. Goals of the Sentinel Event Policy The policy has four goals: To have a positive impact in improving patient care, treatment, and services and preventing sentinel events. To focus the attention of an organization that has experienced a sentinel event on understanding the causes that underlie the event, and on changing the organization’s systems and processes to reduce the probability of such an event in the future. To increase general knowledge about sentinel events, their causes, and strategies for prevention. To maintain the confidence of the public and internationally accredited organizations in the accreditation process. Standard Relating to Sentinel Events The “Quality Improvement and Patient Safety” (QPS) chapter of this publication contains standard QPS.5 (see page 151), which relates specifically to the management of sentinel events. Organization-Specific Definition of a Sentinel Event QPS.5 requires each accredited organization to establish which unanticipated events are significant and the process for their intense analysis. While the determination of what constitutes a significant event must be consistent with the general definition of sentinel event as described in this policy, accredited organizations have some latitude in setting more specific parameters to define “unanticipated” and “major permanent loss of function.” At a minimum, an organization must include those events that are subject to review under QPS.5 and the JCI Sentinel Event Policy. Expectations for an Organization’s Response to a Sentinel Event Accredited organizations are expected to identify and respond appropriately to all sentinel events (as established by the organization in accordance with the previous paragraph) occurring in the organization or associated with services that the organization provides, or provides for. Appropriate response includes conducting a timely, thorough, and credible root cause analysis (also see Glossary); developing an action plan designed to implement improvements to reduce risk; implementing the improvements; and monitoring the effectiveness of those improvements. Root Cause Analysis Root cause analysis is a process for identifying the basis or causal factors that bring about variation (also see Glossary) in performance, including the occurrence, or possible occurrence, of a sentinel event. A root cause analysis focuses primarily on systems and processes, not on individual performance. Action Plan The product of the root cause analysis is an action plan that the organization intends to implement in order to reduce the risk of similar events occurring in the future. The plan should address responsibility for implementation, oversight, pilot testing as appropriate, time lines, and strategies for measuring the effectiveness of the actions. Survey Process When conducting an accreditation survey, JCI seeks to evaluate the organization’s compliance with the applicable standards and to score those standards based on performance throughout the organization over time (for example, the preceding 12 months for a triennial re-survey or the preceding four months for an initial survey). If, in the course of conducting the usual survey activities, a sentinel event is identified, the surveyor will take the following steps: Inform the CEO that the event has been identified. Inform the CEO that the event will be reported to the JCI Central Office for further review and follow-up under the provisions of the Sentinel Event Policy. During the on-site survey, the surveyor(s) will assess the organization’s compliance with sentinel event related standards in the following ways: Review the organization’s process for responding to a sentinel event. Interview the organization’s leaders and staff about their expectations and responsibilities for identifying, reporting, and responding to sentinel events. Ask for an example of a root cause analysis that has been conducted in the past year to assess the adequacy of the organization’s process for responding to a sentinel event. Review additional examples if needed to more fully assess the organization’s understanding of and ability to conduct root cause analyses. In selecting an example, the organization may choose a “closed case” to demonstrate its process for responding to a sentinel event. How JCI Becomes Aware of a Sentinel Event Each hospital is encouraged, but not required, to report to JCI any sentinel event meeting the above criteria for reviewable sentinel events. Alternatively, JCI may become aware of a sentinel event by some other means such as communication from a patient, a family member, an employee of the hospital, a surveyor, or through the media. Reasons for Reporting a Sentinel Event to JCI Although self-reporting a sentinel event is not required and there is no difference in the expected response, time frames, or review procedures, whether the hospital voluntarily reports the event or JCI becomes aware of the event by some other means, there are two major advantages to the hospital that self-reports a sentinel event: Early reporting provides an opportunity for consultation with JCI central office staff during the development of the root cause analysis and action plan. The organization’s message to the public that it is doing everything possible to ensure that such an event will not happen again is strengthened by its acknowledgement and collaboration with JCI to understand how the event happened and what can be done to reduce the risk of such an event in the future. Reviewable Sentinel Events The definition of a reviewable sentinel event takes into account a wide array of occurrences applicable to a wide variety of health care organizations. These occurrences may apply to a particular hospital. Thus, one of the following occurrences may apply to your particular hospital. The following sentinel events are subject to review by JCI and include any occurrence that meets the following criteria: The event has resulted in an unanticipated death or major permanent loss of function; or The event resulted from wrong-site, wrong-patient, wrong-procedure surgery Required Response to a Reviewable Sentinel Event If JCI becomes aware (either through voluntary self-reporting or otherwise) of a sentinel event that meets the above criteria and the event has occurred in an accredited organization, the organization is expected to do the following: Prepare a thorough and credible action plan within 45 calendar days of the event or of becoming aware of the event. Submit to JCI its root cause analysis and action plan, or otherwise provide for JCI evaluation of its response to the sentinel event. Review of Root Cause Analysis and Action Plan A root cause analysis will be considered acceptable if it has the following characteristics: The analysis focuses primarily on systems and processes, not individual performance. The analysis from specific causes in the clinical care process to common causes in the organizational process. The analysis repeatedly digs deeper. The analysis identifies changes that could be made in systems and processes (either through redesign or development of new systems or processes) which would reduce the risk of such events occurring in the future. All root cause analyses and action plans will be considered and treated as confidential by JCI. Follow-Up Activities After JCI has determined that an organization has conducted an acceptable root cause analysis and developed an acceptable action plan, JCI will notify the organization that the root cause analysis and action plan are acceptable and will assign an appropriate follow-up activity, typically a written progress report due in four months. Implementing the Sentinel Event Policy If an organization wishes to report an occurrence in the subset to sentinel events that are subject to review by JCI, the organization can submit the report to the JCI central office by mail, electronic, or by facsimile transmission. If JCI becomes aware of a sentinel event subject to review under the sentinel event policy which was not reported to JCI by the organization, the CEO of the organization is contacted, and a preliminary assessment of the sentinel event is made. An event that occurred more that one year before the date JCI became aware of the event will not, in most cases, be reviewed under the Sentinel Event Policy. In such a case a written response will be requested from the organization, including a summary of the processes in place to prevent similar occurrences. Based on available factual information received about the event, JCI staff will apply the above definition to determine that an event is reviewable under the Sentinel Event Policy. Challenges to a determination that an event is reviewable will be resolved through consultation with the JCI executive director and JCI chief medical officer. Initial On-Site Review of a Sentinel Event An initial on-site review of a sentinel event will usually not be conducted unless it is determined that there is a potential ongoing immediate threat to patient health and safety or potentially significant noncompliance with JCI standards. Immediate threat-to-life incidents include situations in which the organization’s noncompliance with one or more standards has caused, or is likely to cause, major permanent loss of function, impairment, or death to a patient and is likely to continue. Complaints are assigned this priority if the information indicates immediate corrective action is necessary. All are immediately referred to JCI executive leadership for authorization to conduct a focused survey. If a focused survey is conducted, the organization will be billed an appropriate amount based on the established fee schedule to cover the cost of conducting such a survey. Disclosable Information If JCI receives an inquiry about the accreditation decision of an organization that has experienced a reviewable sentinel event, the organization’s accreditation decision will be reported in the usual manner without making reference to the sentinel event. If the inquirer specifically references the specific sentinel event, JCI will acknowledge that it is aware of the event and currently working or has worked with the organization through the sentinel event review process. Information on Accreditation Status Available to the Public JCI is committed to making relevant and accurate information about surveyed organizations available to the public. Information about an organization’s performance not only helps providers to improve their services, but also helps educate users of the organization. Such information may also help patients and payors make informed choices in selecting health care providers. However, it is important that confidentiality be maintained for certain information to encourage openness in the accreditation process. This openness facilitates improvement of the quality of health care to benefit the public. Please refer to the section on confidentiality in this chapter (page for specific information on this issue. Accreditation Award Display and Use JCI provides each organization with a certificate of accreditation at the time of initial accreditation and at the time of accreditation renewal. There is no charge for the certificate. Additional copies of certificates may be purchased by contacting JCI. The certificate and all copies remain JCI’s property. They must be returned if the organization is issued a new certificate reflecting a name change; or the organization’s accreditation is withdrawn or denied for any reason. An organization accredited by JCI must be accurate in describing to the public the nature and meaning of its accreditation award. Therefore, an organization must not misrepresent its accreditation status or the facilities and services to which the accreditation award applies. JCI will supply each organization receiving accreditation with appropriate guidelines for announcing the accreditation award. Reporting Requirements Between Surveys Accreditation is neither automatically transferred nor continued if significant changes occur within the organization. Such changes may necessitate a full or focused accreditation survey if the organization has instituted a new service or program for which JCI has standards; changed ownership and there are a significant number of changes in the management and clinical staff or operating policies and procedures; • offered at least 25% of its services at a new location or in a significantly altered physical facility; expanded its capacity to provide services, or use of its services, by 25% or more as measured by beds, patient visits, pieces of equipment, or other relevant measures; reduced its capacity to provide services, or use of its services, by 25% or more as measured by beds, patient visits, pieces of equipment, or other relevant measures; developed a more intensive level of service (for example, from outpatient cardiac rehabilitation to inpatient invasive [also see Glossary] diagnostic cardiology); or merged with, consolidated with, or acquired an unaccredited site, service, or program for which there are applicable JCI standards. When any of these changes occur, the organization must notify JCI in writing not more than 30 days after such a change occurs. Failure to provide timely notification to JCI of these changes may result in loss of accreditation. If an accredited organization is purchased by another organization or is physically or organizationally merged with another organization, JCI may decide that the organization responsible for providing the clinical services must be re-surveyed or initially surveyed, if not previously accredited. Barring exceptional circumstances, JCI continues accreditation of the organization undergoing the kind of changes described above until it determines whether a full or focused accreditation survey is necessary. Table of Changes The following table details the significant changes found in this 3rd edition of the Joint Commission International Accreditation Standards for Hospitals as compared to the 2nd edition, which was published in 2003. Chapter Significant Change(s) Foreword New     Introduction Updated and revised     Joint Commission International Accreditation Policies New policies have been added related to the following: • Accreditation decision process • Appeal of accreditation decisions • Focused surveys • Validation surveys • Tracer methodology • Sentinel events • Accreditation fee structure     International Patient Safety Goals New chapter containing six international patient safety goals, requirements, intent statements, and measurable elements.       Terminology in this chapter (and throughout other chapters), clarified to differentiate “admission as an inpatient” from “registration as an outpatient.” Also, the term “outpatient” is now used to replace “ambulatory” patient.   ACC.1— new requirement introduced related to informing patients when they will be placed on a “wait list”; clarifications of those tests considered “screening” vs. “diagnostic” are made by combining two standards into this revised standard.   ACC.1.4—related to the admission or transfer into or between units, and other standards that reference the use of “criteria,” now require that such criteria be “physiologic-based.” Access to Care and Continuity of Care (ACC) ACC.3—related to the discharge or referral of patients, now requires a “policy” rather than a “process” to support the referral or discharge; now requires a policy and procedure when inpatients are permitted to leave the hospital for a period of time, such as a weekend leave. ACC.3.2—now requires that a copy of the discharge summary be provided to the practitioner responsible for the patient’s continuing or follow-up care. Standards related to “Transportation” were added. ACC.5—applies to all organizations. ACC.6 and ACC.6.1—apply only to those organizations that own and operate a medical transport service. Five standards from this chapter that address aspects of communication were moved to the revised Management of Communication and Information (MCI) chapter. Patient and Family Rights (PFR) PFR.1.1.1—expanded to require a process to satisfy a patient’s request for pastoral services from a religion not recognized by the country. PFR.1.2—intent statement clarified to better facilitate the process of respecting each patient’s privacy needs. PFR.1.6—modified to make informing patients about the confidentiality of information explicit, including when information will be released and when the patient will have to grant permission for the release of information; patient access to their own health information was added to MCI.10. PFR.2.4—revised to recognize the personal, cultural and societal influences on how patients report pain and manage pain. PFR.6.3—general consent for care and treatment is made an optional choice for each organization. PFR.6.4—informed consent for anesthesia is now also required for moderate and deep sedation. PFR.7 through PFR.9—standards related to research were moved into a separate section. PFR.10 and PFR.11—standards related to organ donation were moved to a separate section and were expanded to include the transplantation and donation processes, as well as the need to educate staff on legal and ethical issues related to organ donation and transplantation. Standards related to organization ethics were moved to the Governance, Leadership and Direction (GLD) chapter as GLD.6 through GLD.6.2. Two standards from this chapter that address aspects of communication were moved to the revised Management of Communication and Information (MCI) chapter.     Assessment of Patients (AOP) AOP.1 and AOP.1.1—clarified to better differentiate the assessment process for inpatients and for outpatients. The use of clinical practice guidelines (formerly AOP.1.2) has been moved to the Quality and Patient Safety (QPS) chapter as QPS.2.1. AOP.1.4.1—now requires that the nursing assessment for inpatients be completed within 24 hours of admission; the process for updating or repeating initial medical assessments older than 30 days is clarified in AOP.1.4 and AOP.1.4.1. AOP.1.5—acknowledges that the initial assessment of patients may be located in places other than the patient’s record, as long as those places are standardized and the assessments are readily accessible to all caregivers. AOP.1.7—now includes women in labor, and patients with emotional or psychiatric disorders, among those “special populations” that may require individualized assessments. AOP.1.8.1—assessment of need for discharge planning was placed in this separate standard. The screening for and the assessment of pain (when found) were moved from the Care of Patients (COP) chapter to AOP.1.8.2, along with other types of assessments. AOP.2—now defines more clearly the circumstances when physicians’ assessments may occur less frequently than daily.   AOP.4 and AOP.4.1—the process for the integration of all assessments for a patient was moved from the end of the chapter to these standards. AOP.5.3 and AOP.5.9—now address point-of-care testing as part of the laboratory director’s responsibilities. AOP.5.10.1—clarified to indicate that only “specialty” laboratory tests, not all tests, are included in the proficiency testing process. Radiology Services now also include “Diagnostic Imaging.” AOP.6.2—expanded to include radiation oncology and the cardiac catheterization laboratory in the organization’s radiation safety program. AOP.6.3—expanded to ensure that qualified individuals are involved in performing, interpreting, and reporting test results.     Care of Patients (COP) The standards for anesthesia and surgery were moved to the new chapter, Anesthesia and Surgical Care (ASC); standards related to medications were moved to the new chapter, Medication Management and Use (MMU) (see below for changes to these standards). COP.1 —concept of “uniform care” clarified to emphasize that care should be uniform all shifts each day and every day of the week. COP.2.1—regarding care planning, was strengthened to include: who is responsible for the planning; that the planning is individualized based on the patient’s assessments; the plan is written in the patient’s record in the first 24 hours; and is updated or revised as appropriate. COP.2.2—now requires that a policy identifies those diagnostic tests for which a clinical indication/rationale is included in the request for the test. COP.2.3—related to the documentation of procedures in the patient’s record, has been clarified to indicate the types of “procedures” to which the standard applies, and notes that the documentation of surgical procedures has been moved to the Anesthesia and Surgical Care (ASC) chapter. COP.2.4—new standard requires that patients are informed of the outcomes of care, including unanticipated outcomes. The standards related to clinical practice guidelines and clinical pathways (formerly COP.3 and COP.4) were combined and moved to the Quality and Patient Safety (QPS) chapter as QPS.2.1. COP.3.8—now includes “children and populations at risk for abuse.” COP.3.9—new standard requires policies and procedures to guide the care of patients on chemotherapy or other high-risk medications. COP.3.1 through COP.3.9—now require specific elements to be within the policies and procedures that guide the care of high-risk patients or provision of high-risk services. The standard requiring policies and procedures related to moderate and deep sedation (formerly COP.5.9) was moved to the Anesthesia and Surgical Care (ASC) chapter as ASC.3. The standard related to anesthesia equipment and supplies (formerly COP.9) was broadened to include all equipment and supplies within the organization and was relocated to the Governance, Leadership, and Direction (GLD) chapter as GLD.3.2.1. COP.4 through COP.5—are combined and simplified versions of what were previously the standards for Food and Nutrition Therapy. COP.6 through COP.7.2.—are combined and simplified versions of what were previously the standards for Pain Management and End-of-Life Care. Anesthesia and Surgical Care (ASC) This new chapter represents primarily the Anesthesia Care standards (formerly COP.6 through COP.9) and the Surgical Care standards (formerly COP.10 through COP.10.4) from the Care of Patients (COP) chapter. These standards were revised and new standards added. The Introduction contains a new “Applicability” statement. ASC.1 and ASC.2—new standards relate to the overall organization and management of anesthesia services. ASC.3—for moderate and deep sedation care, now identifies the elements of appropriate policies and procedures for sedation care, identifies who is involved in the development of those policies and procedures, requires a pre-sedation assessment, identifies the qualifications of practitioners providing moderate and deep sedation care, as well as the monitoring process. ASC.4—pre-anesthesia assessment and the pre-induction assessment were combined into this standard. ASC.6—revised to indicate that discharge from the post-anesthesia recovery area could be by a qualified individual or by using established criteria. ASC.7.2—modified to indicate that either the surgical report or a brief surgical note must be in the patient’s record prior to their leaving the post-anesthesia recovery area.     Medication Management and Use (MMU) This new chapter represents primarily the Medication Use standards (formerly COP.11 through COP.11.6.3) from the Care of Patients (COP) chapter. These standards were revised, new standards added and the standards organized around the primary processes of safe medication management, including • Organization and management; • Selection and procurement; • Storage; • Ordering and transcribing; • Preparing and dispensing; • Administration; and • Monitoring Most standards, intent statements, and measurable elements now contain more specific requirements. MMU.1—includes new requirements for • a plan or policy on how medication use is organized, • policy-driven use throughout the organization, • documented review of the medication management system at least every 12 months, and • making sure sources of drug information are available. MMU.2.1—contains new expectations related to the medication list, including the monitoring of patient response to medications added to the list and an annual review of the list based on safety and efficacy information. MMU.3—contains new, more specific expectations regarding storage of medications, including the storage of concentrated electrolytes. MMU.3.1—revised to require policies and procedures related to the storage of several types of medications and storage of parenteral nutritional products. MMU.4.1—new standard describes the required elements of a complete order or prescription.   MMU.5.1—sets new and explicit requirements for the review of the appropriateness of a medication prescription or order. MMU.6.1—sets new expectations for the process to verify the medication prior to administration. Patient and Family Education (PFE) The assessment of a patient’s educational needs (formerly PFE.1.1) was separated into two standards: PFE.2, which focuses on the identification of what information needs to be learned, and PFE.2.1, which focuses on the understanding of the patient’s and family’s ability and willingness (formerly “readiness”) to learn. PFE.3—now includes new expectations on how community resources are used to meet patient education needs.   PFE.4—pain management was added to the list of topics for patient education.   PFE.6—now includes more specific qualifications for those who provide patient education.       QPS.1 through QPS.1.5—reorganized and revised with separate intent statements in order to increase the expectations of leadership and governance for quality planning and oversight.   QPS.1—revised to include leadership participation in the development of a quality and patient safety plan and the reporting of progress in meeting that plan to the governance of the organization.   QPS.1.1—revised with new expectations related to system thinking and the coordination of all elements of quality and safety within the organization.   QPS.1.2—sets new expectations for the role of leaders in priority setting including the implementation of the International Patient Safety Goals.   QPS.2.1—sets explicit requirements for the process of adopting or adapting clinical practice guidelines and clinical pathways, and now requires that at least one guideline or pathway is adopted or adapted each 12 months. Quality Improvement and Patient Safety (QPS) QPS.3—sets new expectations that leaders consider “science” and “evidence” when selecting priority clinical and managerial quality monitors, that the monitoring is part of the organization’s quality and patient safety program, and that the results of monitoring are communicated to the oversight mechanism and periodically to the leaders and governance. The clinical monitors were revised to separate clinical laboratory (QPS.3.2) and radiology (QPS.3.3) monitors, and separate medication errors and near misses (QPS.3.6) from the monitoring of medications and antibiotics (QPS.3.5). QPS.3.7 now includes monitoring anesthesia and sedation. QPS.4—revised to require the use of statistical tools and techniques in the data analysis process. QPS.5—sets new expectations for identifying and managing sentinel events. This standard now requires the inclusion of three events in the organization’s definition of a sentinel event: conducting a root cause analysis on every event that meets the definition, a timely analysis process, and evidence the hospital’s leaders have taken action on the results of the root cause analysis. QPS.6—new standard sets expectations for how adverse events and undesirable trends are analyzed. The analysis process for these events and trends does not require a root cause analysis. QPS.7—new standard that sets expectations for how near-miss events are defined, reported and analyzed.   QPS.10—new standard that sets expectations for proactive risk-reduction activities, with at least one risk-reduction exercise carried out annually.     Prevention and Control of Infections (PCI) This chapter was significantly reorganized with some new expectations added. The term “health care–associated” has replaced “nosocomial” throughout the chapter. PCI.1—moves leadership and coordination to the front of the chapter and sets the new expectation that the individual(s) providing program oversight have clear assignments and accountabilities. PCI.2—strengthened in relation to the coordination of the infection control program by a group and the involvement of infection control professionals. PCI.3—strengthened by adding World Health Organization guidelines and other authoritative sources to the science base of the program. PCI.4—new standard sets expectations for how the organization’s leaders provide adequate resources to support the infection control program including staff and information management systems. PCI.5—significantly revised to set expectation for a comprehensive (formerly coordinated) program including proactive surveillance, outbreak investigation, appropriate policies, and risk-reduction goals and objectives that are regularly reviewed. PCI.6—revised to add epidemiologically significant diseases and organisms, as well as emerging or reemerging infections to the list of important areas on which to focus the program. Several new standards were created from former standard PCI.3 including: PCI.7—related to the overall identification of risk-associated procedures and processes. PCI.7.1—related to adequate equipment cleaning and sterilization including new requirements for when single-use devices are used again. PCI.7.2—related to the proper disposal of waste. PCI.7.3—related to the disposal of sharps and needles. PCI.7.4—related to food service and mechanical and engineering controls. PCI.7.5—related to facility construction and renovation. PCI.8—new standard that sets requirements for isolation procedures. PCI.9—now requires the adoption of hand hygiene guidelines from an authoritative source. PCI.10—now requires that the leadership of the infection control program is part of the organization’s quality and patient safety oversight mechanism. PCI.10.4—now requires the comparison of infection control rates with best practices and scientific evidence. PCI.10.5—now requires action on reports from relevant public health agencies related to infections. PCI.11—now requires organizations to encourage patients and families to participate in the infection control program.     Governance, Leadership, and Direction (GLD) GLD.1—now requires that the performance of the governing body and senior management be evaluated. GLD.1.1—now requires those responsible for governance to periodically review the organization’s mission and to make it public. GLD.1.2—now requires policies and procedures in relation to any delegation of approval authority.   GLD.1.4—now requires governance to review the performance of the senior manager. GLD.1.5—now requires processes that support cooperation between governance and management. GLD.1.6—new standard requiring that those responsible for governance approve the quality and patient safety plan and regularly receive and act on reports of the quality and patient safety program. GLD.3.1—now requires that the organization’s leaders seek community input into planning and commit the organization to participation in community education on health promotion and disease prevention. GLD.3.2—now requires that the clinical leaders of the organization have a process to review and approve care that is considered experimental. GLD.3.2.1—now requires that only recommended equipment and supplies are used. GLD.3.3—now requires department managers to receive and act on the quality reports of contracting agencies. This standard also requires that when independent practitioners provide services outside the organization, such as telemedicine and teleradiology, the practitioners are privileged to provide the services. GLD.5.1—no longer identifies the specific content of a department’s plan for services; rather, a uniform format is used as determined by the organization. GLD.5.2—now requires department directors to have a process for responding to resource shortages. Standards related to Organizational Ethics were moved from the Patient and Family Rights (PFR) chapter to GLD.6 through GLD.6.2. GLD.6.2—new standard requires that the organization’s ethical framework supports decision making in clinical care. Facility Management and Safety (FMS) This chapter has been reorganized. Following an introductory standard on leadership and planning (FMS.1), the sections of the chapter follow the six planning areas: • Safety and security • Hazardous materials • Emergency management • Fire safety • Medical equipment • Utility systems FMS.2—new standard requires that there be written plans that cover all six areas and that they are up-to-date, fully implemented and reviewed at least on an annual basis. FMS.3—requires that the hospital’s governing body receives a report on the effectiveness of the environment management program and ensure consistent and continuous organization and management of the program. FMS.5—now requires that a list of hazardous materials used by the hospital be maintained and that waste be disposed of properly and legally. FMS.6 and FMS.6.1—revised to require organizations to identify likely internal and external disasters and major epidemic events, and the standards specify the content of the emergency management plan related to such events. FMS.8.2—new standard requires a product/equipment recall system.   FMS.10—now requires the organization to identify the key utility, medical gas, ventilation and other systems. FMS.11—now requires that visitors, vendors, contract workers, and others be included in the education program related to safe facility management.       SQE.1 and SQE.1.1—now have separate intent statements with greater detail and clarity. The standards now address the issue of when medical staff and other clinical staff may also need a job description. SQE.3—refocused onto clinical staff working under supervision. SQE.4—new standard focused on non-clinical staff and ensuring their knowledge and skills meet organization needs and the requirements of the position. SQE.8.3—new standard contains requirements for health care organizations that participate in health professional education programs. SQE.8.4—new standard contains requirements for the organization’s health and safety program for staff. The Medical Staff standards (formerly SQE.7 through SQE.9) have   been significantly revised as SQE.9 through SQE.11.   SQE.9—new or revised expectations include:   • the intent identifies the accountability of the organization for the   credentialing process;   • the intent identifies three situations considered acceptable substitutes for   an organization performing primary source verification of physician   credentials; and   • the intent sets clear expectations as to the primary source verification   process for an initial survey and for a triennial survey.   SQE.10—new or revised expectations include: Staff Qualifications • a privileging process that is standardized, objective and evidence based; and Education (SQE) • the intent identifies the information to be used in the privileging process   on initial appointment;   • the intent identifies the information to be used in the reappointment   every three years to the organization; and   • the privileging process is documented in policies, is followed, and can be   demonstrated as to how privileging decisions are reached.   SQE.11—new or revised expectations include:   • the periodic review of physician performance is replaced by an “ongoing   professional practice evaluation”;   • the intent identifies the potential criteria for the evaluation and the   sources of evaluation information; and   • documentation of the professional practice evaluation in the credentials   file. The Nursing Staff standards (formerly SQE.10 through SQE.12) have been significantly revised as SQE.12 through SQE.14. SQE.12—new or revised expectations include: • the intent identifies the accountability of the organization for ensuring nurses are qualified; • the intent identifies (by reference to SQE.9) three situations considered acceptable substitutes for an organization performing primary source verification of nurse credentials; • sets clear expectations as to the primary source verification process for an initial survey and for a triennial survey; and   • sets clear expectations for credentials review of contract nurses. SQE.14—includes this new expectation: • The results of the nurse review process are documented in the credentials file. Other Health Professional Staff standards (formerly SQE.13 through SQE.15) have been significantly revised as SQE.15 through SQE.17. SQE.15—new or revised expectations include: • the intent identifies the accountability of the organization for ensuring other health professional staff are qualified; • the intent identifies (by reference to SQE.9) three situations considered acceptable substitutes for an organization performing primary source verification of other health professional credentials; and • sets clear expectations as to the primary source verification process for an initial survey and for a triennial survey.     Management of Communication and Information (MCI) Standards related to communication have been gathered from other standards chapters, revised, and added to the beginning of this chapter. This greater emphasis on communication reflects the growing understanding of the importance of good communication in safe patient care. The chapter has also been reorganized and re-titled Management of Communication and Information (MCI; formerly Management of Information or MOI). MCI.4—new standard sets expectations for effective communication between providers within and outside the organization. MCI.9—requires planning information management processes but no longer requires that there be an information management plan. Requirements related to information confidentiality, security and integrity (formerly MOI.1.4 and MOI.1.5) have been divided into two standards: MCI.10—relates to information privacy and confidentiality. MCI.11—relates to security and data integrity. MCI.13—expanded to include the standardization of abbreviations and identification and monitoring of those that are not to be used in the organization. MCI.19—revised to clarify that a clinical record is started for all patients; inpatients, outpatients, and emergency patients.     Glossary Revised and expanded     Index Revised and expanded       A new chapter contains the International Patient Safety Goals. The medication management standards have been revised and made into a separate chapter entitled “Medication Management and Use” (MMU). The surgery and anesthesia standards have been revised and made into a separate chapter entitled “Anesthesia and Surgical Care” (ASC). Standards related to communication processes have been gathered from throughout the chapters and combined with information management standards into a revised chapter entitled “Management of Communication and Information” (MCI). The processes for the initial and periodic review of the credentials and competence of physicians, nurses and allied health professionals have been made very explicit with higher expectations related to the portions of the process needed to ensure safe, quality care in an organization. The standards for infection control (“Prevention and Control of Infections”) have been revised and now include standards related to isolation procedures. A new standard is introduced related to the oversight of health professional education in the organization. A new standard is introduced regarding the provision of an employee health and safety program. The expectations regarding the evaluation of sentinel events and adverse events have been clarified and new expectations for a proactive process introduced. Cross references have been included throughout the text, guiding readers to related standards and other associated information. The Glossary has been updated and expanded. The Index has been expanded significantly to facilitate the user in navigating between related standards and topics. Joint Commission International Accreditation Policies Health care organizations wishing to be accredited by Joint Commission International (JCI) must meet the following requirements. General Eligibility Requirements for Survey Any health care organization (also see Glossary) may apply for JCI accreditation (also see Glossary) if it meets the following requirements: The organization is currently in operation as a health care provider in the country, and licensed (if required). The organization assumes, or is willing to assume, responsibility for improving the quality of its care and services. The organization provides services addressed by JCI standards. Purpose of an Accreditation Survey An accreditation survey (also see Glossary) assesses an organization’s compliance with JCI standards and their intent statements. The survey evaluates the organization’s compliance based on interviews with staff and patients and other verbal information; • on-site observations of patient care processes (also see Glossary) by the surveyors; policies, procedures, and other documents provided by the organization; and results of self-assessments when part of the accreditation process. The on-site survey process, as well as continued self-assessment, helps organizations identify and correct problems and improve the quality of care (also see Glossary) and services. In addition to evaluating compliance with standards and their intent statements, surveyors spend time in providing education in support of the organization’s quality improvement activities. Scope of Accreditation Surveys The scope of the JCI survey includes all standards-related functions of an applicant organization and all patient care settings. Applicable standards are selected by JCI from this manual based on the scope of services (also see Glossary) provided by an organization applying for survey. The on-site survey will consider specific cultural and/or legal factors which may influence or shape decisions regarding the provision of care and/or policies and procedures in an organization. Outcomes of Accreditation Surveys The Accreditation Committee of JCI makes accreditation decisions (also see Glossary) based on the findings of the survey. An organization can receive one of the following two accreditation decisions: Accredited: An accreditation decision that results when an organization demonstrates acceptable compliance with each JCI standard (a score of at least “5” on each standard); acceptable compliance with the standards in each chapter (an aggregate score of at least “7” for each chapter); • overall acceptable compliance (an aggregate score of at least “8.5” on all standards); and acceptable compliance with all International Patient Safety Goals (a score of at least “5” on all goal requirements). Accreditation Denied: An accreditation decision that results when an organization is consistently not in compliance with JCI standards and International Patient Safety Goals, including • one or more standards scored less than a “5”; an aggregate score of less than “7” for each chapter; an aggregate score of less than “8.5” on all standards; • one or more International Patient Safety Goal requirements is scored a “0”; a required follow-up focused survey (also see Glossary) has not resulted in acceptable compliance with the applicable standards and/or International Patient Safety Goal requirements; when JCI withdraws its accreditation for other reasons; or when the organization voluntarily withdraws from the accreditation process. Accreditation Awards To gain accreditation, organizations must demonstrate acceptable compliance with all core and non-core standards and achieve a minimal numerical score on these standards. Above this basic level of standards compliance, the organization’s numerical score will indicate the overall standards achievement level. Accredited organizations receive a final accreditation report and award certificate. The report indicates the level of compliance with JCI standards achieved by the organization. Length of Accreditation Awards An accreditation award is valid for three years unless revoked by JCI. The award is retroactively effective on the first day after JCI completes the organization’s survey or, when follow-up is required, completes any required focused surveys. At the end of the organization’s three-year accreditation cycle, the organization must be reevaluated to be eligible for renewal of its accreditation award. If, during the period of accreditation, the organization undergoes changes in its structure, ownership, or services, it must notify JCI. JCI will then determine the need to re-survey the organization and render a new accreditation decision. If, during the period of accreditation, JCI receives information that the organization is substantially out of compliance with the current accreditation standards, JCI will determine the need to re-survey the organization and/or render a new accreditation decision. Information Accuracy and Truthfulness The organization must provide accurate and truthful information at all times in the accreditation process. If the organization falsifies information relevant to the accreditation, either by commission or omission, its accreditation award will immediately be terminated, or in the case of a new applicant, the organization will be ineligible for reevaluation for one year. Falsification is the fabrication, in whole or in part, of any information provided by an applicant or accredited organization to JCI. This fabrication includes altering the content of documents through redrafting, reformatting, or deleting content. How to Apply for Accreditation A health care organization that wishes to be accredited begins the accreditation process (also see Glossary) by completing and submitting the application for survey. This document provides essential information about the health care organization, including ownership, demographics, and types and volume of services provided. The application for survey describes the organization seeking accreditation; requires the organization to provide JCI with all official records and reports of relevant licensing, regulatory, or other governmental bodies; authorizes JCI to obtain any records and reports about the organization not possessed by the organization; and when finalized and accepted by JCI and the applicant, establishes the terms of the relationship between the organization and JCI. The health care organization may apply in electronic format by downloading an application form at http://www.jointcommissioninternational.com and returning the complete form by facsimile or e-mail to: Lisa Stahly Manager, International Accreditation Services Fax: +1-630-268-3743 E-mail: lstahly@jcrinc.com The organization must inform JCI about any changes to the information contained in its application for survey between when the application is submitted and until the survey is conducted. Scheduling the Survey and Planning the Survey Agenda JCI and the organization select the survey date (usually within 90 days from the receipt of the application) and prepare the survey agenda together to meet the organization’s needs and the requirements for an efficient survey. To reduce surveyor travel costs, JCI will make every effort to coordinate the scheduling of surveys of related or independent organizations in a specific country or region. JCI will assign each organization an accreditation service specialist, who will serve as the primary contact between the organization and JCI. This individual will coordinate survey planning and will be available to the organization to answer any questions about policies, procedures, or accreditation issues. The accreditation service specialist will work with the organization to prepare a survey agenda based on the size, type, and complexity of the health care organization. The agenda specifies the sites in the organization to be visited, the type of interviews to be conducted, the personnel to be interviewed, and the documents to be provided to the surveyors. Highly qualified international surveyors will perform the survey. JCI will make every effort to provide surveyors fluent in the language(s) used at the organization. If JCI surveyors with the appropriate language capabilities are not available, JCI will work with the organization to identify qualified interpreters. Circumstances may arise when the organization or JCI must postpone the scheduled survey or may wish to cancel the scheduled survey. See “JCI Accreditation Fee Structure Policy” below for more details. JCI Accreditation Fee Structure Policy The accreditation survey fee is based on several factors, including the volume and type of services provided by the organization, the number of locations or care settings included in the survey, and the number of surveyors and survey days required to conduct an evaluation of compliance with JCI hospital standards. Surveyor time for report preparation is included in the calculated survey days. The organization is not charged for the cost of a validation survey. Initial and Triennial Hospital Accreditation Fee For most hospitals, a three-member survey team conducting a three-day survey will be needed to efficiently conduct a comprehensive evaluation. For larger or smaller hospitals, the fees will be adjusted upward or downward as appropriate. Included in fee are • Survey Process Guide; custom survey agenda; all supporting information and assistance regarding the on-site survey process and interpretation of the standards; an internationally experienced survey team consisting of physician; nurse; and administrator all preliminary and final reports; and an accreditation certificate. Focused Survey Fee Focused surveys are conducted when JCI becomes aware of potentially serious standards compliance, patient care or safety issues, or when JCI has other valid reasons for surveying an accredited organization. The focus survey reviews only the standards and/or International Patient Safety Goal requirements in non-compliance at the time of survey or addressed in an incident report. In most cases, a focused survey is conducted by one surveyor during one day. However, JCI reserves the right to assign more than one surveyor or schedule more than one day when indicated by the number of standards to be surveyed, or the variety of survey activities. Postponement Fee In rare circumstances, JCI may, at its discretion, approve a request to postpone a survey for an organization not meeting any of the criteria described here. In such cases, the organization may be charged a fee to defray costs. Accepted reasons for postponement. An organization may postpone scheduled surveys when one or more of the following events happen: A natural disaster or another major unforeseen event occurs that totally or substantially disrupts operations. The organization is involved in a major strike, has ceased accepting patients, and is transferring (also see Glossary) patients to other facilities. Patients, the organization, or both are being moved to another building during the scheduled survey. JCI reserves the right to conduct an on-site survey if the organization continues to provide patient care services under such circumstances. Cancellation Fee A survey may be canceled by either party without penalty or damages in the event of acts of God, war, terrorism, government regulation, disaster, strikes, civil disorders or other emergencies of a similar nature that make it impossible, illegal or unreasonable to go forward provided notice of the event requiring cancellation is communicated in writing as soon as practically possible. Further, JCI may follow the advice of relevant ministries concerned with evaluating political and military circumstances with regard to scheduling surveys. Organization-driven cancellation. If the organization cancels the survey thirty (30) or fewer days prior to the first date of the survey for any reason or reasons other than those previously stated, JCI accreditation may require payment of one-half of the survey fees to recover costs JCI accreditation will incur. JCI-driven cancellation. In the event that JCI cancels the survey for any reason or reasons other than those previously stated, the organization will not be charged. Travel Costs Related to the Accreditation Survey or Focused Survey In addition to survey fees, the organization is responsible for paying all travel costs for the surveyors. This includes transportation (airfare, train, and car) and accommodations, including a set daily rate for meals and incidental expenses. This rate will not exceed the current rates set forth by the United States Department of State for international travel. Payment of Survey Fees All fees are payable in United States currency. All fees are on an after-tax basis. If JCI is required to pay local, country, or other taxes, these taxes will be in addition to the fees quoted. An initial payment of 50% is required to secure the survey dates and schedule the survey team. An organization will receive an invoice for the balance of the survey fee and for travel costs of the survey team within 10 days of the on-site survey. The fees for a focused survey are billed separately within 10 days of the focused visit. Confidentiality JCI’s confidentiality policy forbids releasing information gathered from an organization during the accreditation process. The only information that JCI will provide to the public is an accredited organization’s status; that is, whether the organization is accredited or was denied accreditation. When a sufficient database of accredited organizations is available for a comparative report, JCI will then provide the accredited organization’s scores for each chapter of standards; and the accredited organization’s total score. If the organization wishes to use its accreditation to fulfill government requirements (for example, for licensure; also see Glossary), JCI will release additional information, up to and including the accreditation report, to the relevant government agency with the accredited organization’s authorization. The accredited organization may release more detailed information, up to and including its accreditation report, to whomever it wishes. However, when an organization disseminates inaccurate information about its accreditation, JCI reserves the right to clarify information that would otherwise be considered confidential. Accreditation Decision Process The Accreditation Decision The final accreditation decision is based on an organization’s compliance with JCI standards. Organizations do not receive a numeric score as part of the final accreditation decision. When an organization successfully meets the JCI requirements, it will be awarded an accreditation decision of “Accredited” via JCI’s Official Accreditation Survey Findings Report. This decision indicates that an organization is in compliance with all applicable standards and International Patient Safety Goals at the time of the on-site survey or has successfully addressed all survey requirements for improvement in its written progress report within 60 days after survey for re-surveys, or within six months for initial surveys. Length of Accreditation Awards An accreditation award is valid for three years unless revoked by JCI. The award is retroactively effective on the first day after JCI completes the organization’s survey or, when follow-up is required, completes any focused surveys. An organization’s accreditation is not automatically renewed after three years. Rather, an organization seeking to continue its accreditation must again undergo a full accreditation survey, resolve any follow-up conditions, and again be found to be in satisfactory compliance with the standards and International Patient Safety Goals. Accreditation Renewal Process JCI sends the organization a Request to Re-survey before the organization’s triennial (every three years) accreditation due date. The organization is responsible for completing and returning the Request for Re-survey to JCI by a specified date. JCI schedules the survey. Every effort is made to schedule the triennial survey to occur at the approximate conclusion of the previous three-year accreditation cycle. JCI will work with the organization and other organizations in the country or region due for surveys to schedule the appropriate survey date(s). An organization’s previous accreditation status may remain in effect up to two months after the subsequent full accreditation survey to accomplish any required follow-up. If during the period of accreditation, the organization undergoes changes in its structure, ownership, or services, it must notify JCI. JCI will then determine the need to re-survey the organization and render a new accreditation decision. If during the period of accreditation, JCI receives information that the organization is substantially out of compliance with current accreditation standards, JCI will determine the need to re-survey the organization and/or render a new accreditation decision. (Also see JCI Focused Survey Policy below) Revision of the Official Accreditation Survey Findings Report The organization has 30 days from receipt of its Official Accreditation Survey Findings Report to request, in writing or by e-mail, revision of the report related to survey findings. This revision request must be accompanied by appropriate data and information to support the request. The JCI Accreditation Committee will consider this request for revision and will make the final decision. Making and Reporting Improvements Related to Survey Findings JCI requires an organization to satisfy all recommendations for follow-up improvements within a specified time frame. The demonstration of satisfactory improvements is made through a written progress report, a focused survey, or both. The time frame for follow-up and the type of follow-up activity are determined by the rules established by the JCI Accreditation Committee, which are applied to the findings of the full accreditation survey.  An organization cannot be accredited until all conditions requiring a follow-up focused survey are satisfactorily resolved. Appeal of Decisions when JCI Accreditation Is Denied or Withdrawn If, based on full, focused, or other survey activity, or a threat-to-life situation, there is a decision to deny or withdraw accreditation, an organization has 20 calendar days from receipt of its Official Accreditation Survey Findings Report or notice of accreditation withdrawal to notify JCI, in writing or by e-mail, of its intent to appeal the decision. An organization then has an additional 60 days to submit to JCI, in writing or by e-mail, acceptable data and information to support its appeal. If, after JCI review of any submitted materials, the decision to deny or withdraw accreditation is confirmed, an organization may, at its own expense, appear before the JCI Accreditation Committee to support its appeal. The following outlines the review and appeal procedure: Notification to organization of areas of noncompliance with JCI standards or conditions related to threat to life. If JCI staff, based on survey findings, survey documents, and any other relevant materials or information received from any source, determine, in accordance with decision rules approved by the JCI Accreditation Committee, to recommend to the JCI Accreditation Committee that the organization be denied accreditation or have its accreditation withdrawn, staff will outline its findings and determination. The organization may then do the following: a) Accept the findings and determination or b) Submit to JCI evidence of its compliance with the cited JCI standards at the time of survey that is not reflected in the Official Accreditation Survey Findings Report, along with an explanation of why such information was not available at the time of survey or c) Submit to JCI evidence related to the findings of a threat-to-life situation. Consideration of the organization’s response. JCI will review the submissions and, in accordance with the decision rules approved by the JCI Accreditation Committee, do the following: a) Recommend to the JCI Accreditation Committee that the organization be accredited b) Recommend that the organization be denied accreditation Action by the JCI Accreditation Committee. The JCI Accreditation Committee may do one of the following: a) Accredit the organization; b) Deny accreditation to the organization; c) Defer consideration while additional information regarding the organization’s compliance status or the threat to-life situation is gathered and reviewed by JCI Accreditation staff; or d) Order a re-survey or focused survey of the organization and an evaluation of the results to the extent deemed appropriate by the JCI Accreditation staff. If an organization withdraws from the accreditation process after the survey has taken place, the JCI Accreditation Committee will make its decision based on the full accreditation survey findings and follow-up and will render the decision to the organization. JCI Focused Survey Policy JCI may conduct a focused survey to follow a full survey or when it becomes aware of potentially serious standards compliance or patient care or safety issues, or when it has other valid reasons for surveying an accredited organization. In most cases, a focused survey is conducted by one surveyor during one day. However, JCI Accreditation reserves the right to require more than one surveyor or more than one day when indicated by the number of standards to be surveyed, or the variety of survey activities. Note: An organization is charged for a focused survey regardless of the outcome. An organization can determine the cost of such a survey by contacting the JCI Accreditation office. Reasons for a focused survey include the following: a) The need for surveyor observation, staff or patient interviews, or the inspection of the physical facility to confirm that an organization has taken sufficient action to achieve compliance with any JCI standards and/or International Patient Safety Goal(s) identified as not met at the time of initial or triennial survey. or b) The receipt of information regarding the occurrence of any event or series of events in an accredited organization that creates either of the following significant situations: Concern that a continuing threat to the safety or care of patients at risk may exist Indications that the organization has not been in compliance with JCI’s Information Accuracy and Truthfulness Policy. JCI may deny or revoke an organization’s accreditation if the organization does not allow JCI to conduct a focused survey. A focused survey can take place at any point in an organization’s accreditation cycle. A preliminary report is not generated after a focused survey. If the results of the focused survey suggest that the organization falsified any clarifying evidence or reported action taken to reach compliance, the JCI staff will recommend to the JCI Accreditation Committee that accreditation should be denied or revoked as appropriate. If any condition is identified during the focused survey and believed to pose a serious threat to public or patient health or safety, the threat to health and safety protocol (also see Glossary) is immediately implemented as described above (Also see Appeal of Decisions when JCI Accreditation Is Denied or Withdrawn). Procedure Information received from surveyors—upon completion of an initial or triennial survey or by means of an incident report—is reviewed by JCI Central Office staff to determine if a focused survey is necessary to confirm compliance with identified JCI standards and International Patient Safety Goal requirements. If JCI Central Office staff review concludes that a focused survey is necessary, a proposal to perform such a survey is presented to the JCI Accreditation Committee for review, discussion, and approval at the next scheduled meeting. When the focused survey is the result of a full survey, such survey must be completed within 6 months of an initial survey (also see Glossary) and within 2 months of a triennial survey. This determination is included in the Preliminary Report sent to the organization. Focused survey requirements must be completed prior to a decision by the JCI Accreditation Committee. When the focused survey is the result of an incident report or other information received about an accredited organization, the JCI Central Office will notify the accredited organization’s senior leadership that a focused survey must be scheduled within the next 45 days to validate compliance with specific JCI standards and International Patient Safety Goal requirements. Upon completion of the focused survey, JCI’s chief medical officer or executive director of JCI will review the focused survey report findings and make a recommendation to the president of JCI and the JCI Accreditation Committee regarding, as appropriate, whether the organization should be awarded accreditation, denied accreditation, allowed to maintain current accreditation status, or that the current accreditation should be revoked. The JCI Accreditation Committee will consider the JCI staff recommendation at its next scheduled meeting and determine the final accreditation decision. The organization is advised of the accreditation decision within 60 days of the completion of the focused survey and appropriate action is taken. JCI Validation Survey Policy Purpose of the Validation Survey The purpose of the validation survey (also see Glossary) is to evaluate the effectiveness of the JCI survey process in assessing international standards compliance in health care organizations, as part of our internal quality improvement efforts. Hospitals that volunteer for a validation survey will not be invoiced. Validation Survey Process Organizations that have achieved JCI accreditation will be invited to volunteer for a validation survey immediately following the initial or triennial re-survey. Validation surveys will be conducted within 60 to 180 days following initial or triennial re-surveys. The length and components of the survey will replicate the hospital’s most recent initial or triennial survey process. The surveyors assigned to conduct the validation survey will have no information about the results of the hospital’s most recent triennial survey and the hospital will be requested not to share that information with them in any way. The participating hospital’s accreditation decision will not be affected by the findings of a validation survey in accordance with the decision rules applicable to an initial or triennial re-survey. However, if any condition is identified during survey and believed to pose a serious threat to public or patient health or safety, the JCI Central Office will be notified and the JCI threat to health and safety protocol will be implemented. At the completion of the survey, the surveyors will orally report their observations to hospital leadership. A written report will not be left on site. Hospitals that volunteer for a validation survey will be requested not to divulge the results of the validation survey to any person or organization outside of their own. Similarly, JCI will not release any information about this survey to the public. Hospitals that volunteer for a validation survey will not incur any cost. JCI Tracer Methodology Policy Tracer Methodology The tracer methodology (also see Glossary) is the foundation of the JCI on-site survey. The tracer methodology does the following: Incorporates the use of information provided in the accreditation survey application Follows the experience of care for a number of patients through the organization’s entire health care process Allows the surveyor(s) to identify performance issues in one or more steps of the patient care process, or in the interfaces between processes Individual Patient Tracer Activity The individual tracer activity is an evaluation method that is conducted during the on-site survey and is designed to “trace” the care experiences that a patient had while at the hospital. The tracer methodology is a way to analyze a hospital’s system of providing care, treatment, and services using actual patients as the framework for assessing international standards compliance. During an individual tracer, the surveyor(s) will: Follow the course of care, treatment, or service provided to the patient by and within the hospital using current records whenever possible. Assess the interrelationships between and among disciplines and departments, programs, services, or units, and the important functions in the care and services being provided Evaluate the performance of relevant processes, with particular focus on the integration and coordination of distinct but related processes Identify potential concerns in the relevant processes Using the information from the application, the surveyor(s) will select patients from an active patient list to “trace” their experience throughout the organization. Patients typically selected are those who have received multiple or complex services and therefore, more contact with various parts of the organization. This will provide the opportunity to assess continuity of care (also see Glossary) issues. To the extent possible, the surveyor(s) will make every effort to avoid selecting tracers that occur at the same time and may overlap in terms of sites within the organization. Individual Patient Tracer Selection Criteria Patient tracer selection may be based on, but not limited to, the following criteria: Patients in the top five diagnoses group for that organization Patients related to system tracers such as infection prevention and control and medication management (also see page 16) Patients who cross programs (patients scheduled for a follow-up in outpatient care [also see Glossary], patients transitioning from hospital to home care) Patients received from another hospital (long term care patients transferred from the hospital, mental health care clients receiving outpatient services, patients receiving home care services) Patients due for discharge (also see Glossary) that day or the next day Patients who cross programs such as hospital to care continuum The surveyor will follow the patient's experience, looking at services provided by various individuals and departments within the organization, as well as “hand-overs” between them. This type of review is designed to uncover systems issues, looking at both the individual components of an organization, and how the components interact to provide safe and quality patient care. The surveyor(s) may start a tracer where the patient is currently located. He or she can then move to where the patient first entered the organization’s systems; an area of care provided to the patient that may be a priority for that organization; or to any areas in which the patient received care, treatment and services. The order will vary. The number of patients followed under the tracer methodology will depend on the size and complexity of the organization, and the length of the on-site survey. As appropriate to the provision of care being reviewed, the tracer will include the following elements: Review of the record with the staff person responsible for the patient’s care, treatment, or service provided to the patient. If the responsible staff person is not available, the surveyor may speak with other staff members. Supervisor participation in this part of the tracer should be limited. Additional staff involved in the patient’s care will meet with the surveyor as the tracer proceeds. For example, the surveyor will speak to a dietician if the patient being traced has nutritional issues. Observation of direct patient care Observation of medication process Observation of infection prevention and control issues Observation of care planning process Discussion of data use in individual units—quality improvement measures being used, what has been learned, improvements made using data, data dissemination (also see Glossary) Observation of the impact of environment on safety and staff roles in minimizing environmental risk Observation of maintenance of medical equipment (also see Glossary) and review of qualified personnel responsible for the maintenance of the medical equipment Interview with the patient and/or family (if it is appropriate and permission is granted by the patient and/or family; also see Glossary for definition of “family”). The discussion will focus on the course of care, and, as appropriate, attempt to verify issues identified during the tracer. When visiting the emergency department, the surveyor(s) will also address emergency management and explore patient flow issues. Patient flow issues may also be explored in ancillary care areas and other patient care units as relevant to the patient being traced. For example, if the patient received a blood transfusion, the surveyor may visit the blood bank. The surveyor(s) may pull and review two to three additional open or closed records to verify issues that may have been identified. The surveyor(s) may ask staff in the unit, program, or service to assist with the review of the additional records. The following criteria can be used to guide the selection of additional records depending on the situation: Similar or same diagnosis or tests Patient close to discharge Same diagnosis but different physician/practitioner Same test but different location Same age or sex Length of stay Interview with staff Review of minutes and procedures as needed Linkages to Other Survey Activities Issues identified from the individual patient tracer activities may lead to further exploration in the systems tracers or other survey activities such as the facilities tour and the governance and leadership interview. Findings from tracer visits provide focus for other tracers and may influence the selection of other tracers. They may also identify issues related to the coordination and communication of information relevant to the safety and quality of care services. Individual-Based System Tracer Activity Individual-based system tracers look at a specific system or process across the organization. When possible, this activity will focus on the experiences of specific patients or activities relevant to specific patients. This differs from the individual tracers in that during individual tracers, the surveyor follows a patient through his or her course of care, evaluating all aspects of care rather than a system. During an individual-based system tracer, the surveyor(s) will: Evaluate the performance of relevant processes, with particular focus on the integration and coordination of distinct but related processes Evaluate the communication among disciplines and departments Identify potential concerns in the relevant processes An individual-based system tracer includes an interactive session involving a surveyor and relevant staff members based on information from individual tracers. Points of discussion in the interactive session include the following: The flow of the process across the hospital, including identification and management of risk points, integration of key activities, and communication among staff/units involved in the process Strengths in the process and possible actions to be taken in areas needing improvement Issues requiring further exploration in other survey activities
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