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Patient Safety: Achieving a New Standard for Care C Examples of Federal, State, and Private-Sector Reporting Systems The To Err Is Human report (Institute of Medicine, 2000) boosted existing patient safety initiatives and stimulated new ones. In the United States, many types of patient safety reporting systems are now in operation or under development at the federal, state, and private-sector levels. The Institute of Medicine Committee on Data Standards for Patient Safety reviewed a large number of these systems during the study. This appendix summarizes a sample of reporting systems. For each sector the following areas are described: Type of system—reporting or surveillance History of reporting/surveillance system Voluntary or mandatory Reportable events Classification system and severity index Reporting time frame Data collected—format and summary Method of reporting Who reports Root-cause analysis trigger Follow-up, including root cause Other information collected Confidentiality issues Relationship with other reporting systems Relationship with JCAHO
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Patient Safety: Achieving a New Standard for Care I. FEDERAL REPORTING SYSTEMS Overview Within the federal government, eight major patient safety reporting and surveillance systems (see Tables C–1a, C–1b, and C–1c for details) were examined. Most of these systems were initiated by the federal agencies that manage them; however, one was mandated in legislation—the Vaccine Adverse Event Reporting System (VAERS). These federal agencies include the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS), which are all part of the Department of Health and Human Services (DHHS); the Department of Defense (DOD); and the Department of Veterans Affairs (VA). The CDC manages two of the eight systems: the National Nosocomial Infections Surveillance (NNIS) System and the Dialysis Surveillance Network (DSN). The NNIS system has two components—nosocomial infections and antimicrobial use and resistance. The CDC also works jointly with the FDA to manage VAERS. The FDA manages MedWatch, which handles reporting of medical device, biologic and blood product, drug product, and special nutritionals events. CMS is developing and will manage the Medicare Patient Safety Monitoring Program (MPSMS), and the DOD manages the Military Health System Patient Safety Program (MHS PSP). The VA manages the National Center for Patient Safety (NCPS) and is working with the National Aeronautics and Space Administration (NASA) to develop a complementary system called the Patient Safety Reporting System (PSRS). The longest operating of these systems is NNIS, which was initiated by CDC in 1970. The rest began operating after 1990, including several in the past few years. The newest systems are the MPSMS, MHS PSP, and PSRS. Surveillance or Reporting Systems Two types of systems are used: surveillance and reporting. In general, surveillance systems abstract data from patient and other records and/or health care personnel to determine if an adverse event has occurred and/or to analyze the data in order to monitor trends. Reporting systems are designed for individuals to report specific events and, in some cases, conduct root-cause analyses (RCAs) to determine the causal factors for these events.
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Patient Safety: Achieving a New Standard for Care Like surveillance systems, reporting can be used to monitor trends. The two CDC-managed systems and the CMS MPSMS are considered surveillance systems; the other five are for event reporting. Most of these systems are essentially voluntary, with the exception of VAERS and MedWatch, which mandate reporting by certain parties (health professionals, manufacturers, and/or user facilities). In the cases where reporting is mandatory, specific time frames are established within which reports must be received; these time frames vary according to the seriousness of the event. Reportable Events In terms of the events reported and monitored by the federal systems, they vary a great deal from one to the next (see “Reportable events/events monitored” and “Classification system and/or severity index” rows of the tables). Some systems include reporting for close calls (i.e., near misses), while others focus solely on adverse events.1 However, a few general statements can be made about them. The CDC- and FDA-managed systems tend to focus on specific types of adverse events, based on patient outcome or what caused the event—nosocomial infections; infections resulting from hemodialysis; vaccine events; and medical device, biologic and blood product, drug product, and special nutritionals events. Although these systems are quite specific in terms of events reported/monitored, they can be used across numerous health systems. The focus of the other four systems—MPSMS, MHS PSP, NCPS, and PSRS—is essentially the opposite of the first four. They are designed for use within the health systems that serve their members: Medicare, the MHS, and the Veterans Health Administration (VHA). The types of events reported to and monitored by these systems are more general and, in some cases, are not categorized at all. Adverse/serious events are included in all of these systems; however, four of them—MHS PSP, NCPS, PSRS, and MedWatch (for device problems only via MedSun)—also include close calls and/or near misses. Additionally, the MHS PSP includes nonpatient specific events such as a fire or system failure in the facility. Often, an organization will classify an event or determine whether an RCA is needed based on a risk assessment scale. For example, the NCPS reporting system classifies events and close calls using the Safety Assessment Code (SAC) matrix and requires an RCA if a close call or adverse event has a high SAC score or at the discretion of the patient safety manager. 1 Adverse/serious events and close calls/near misses are defined differently by each system (see tables).
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Patient Safety: Achieving a New Standard for Care Format for Reporting Each system requires different data to be abstracted or reported, and most of them have a standard format for collecting those data (see “Data collected: Format and summary” row in the tables). The MHS PSP and NCPS do not use a standardized format for initially collecting data—they allow facilities to use locally accepted methods for reporting—but then report the data to their central agencies in a standardized manner. Most of the systems include patient-specific data in their reports; however, patient (and health care worker) identifiers are removed when the data are shared across the system or with an outside party. All of the data in these systems are protected from discovery by law or regulation. Method of Reporting Five of the systems allow for electronic transmission (via disk, e-mail, or the Internet) of reports to the central office; the rest require submission of hardcopy reports, which are then entered into databases by agency personnel. In terms of who can report to these systems and who abstracts the data, most are open to all personnel at participating facilities. The NNIS, however, uses trained personnel at participating hospitals to compile the data. The MHS PSP and NCPS allow reporting according to their facilities’ locally accepted methods, but specific personnel are responsible for compiling and transmitting the data to the central offices. Only two of these systems currently allow consumers (patients and their families) to report events—VAERS and MedWatch. The MHS PSP also welcomes reports from patients and families but has not yet developed the mechanisms to facilitate this avenue of reporting. Analysis of More Serious Events All of the systems have in place some means for following up on events, although the type and amount of follow-up vary a great deal across the systems. The primary means of follow-up used by the surveillance systems is data analysis and trend monitoring. Most of the systems allow facilities to do this on a local level. Overall analyses and comparisons are usually conducted by the central agency. In such cases, these analyses are often shared with the individual facilities. VAERS and MedWatch both involve reviews of the most serious events by the FDA. These reviews may result in several actions from alerts and label/packaging changes to recalls of vaccine batches or products.
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Patient Safety: Achieving a New Standard for Care MHS PSP and NCPS both involve extensive RCAs and action plans, which must be monitored for effectiveness. NCPS and MHS PSP also require prompt feedback to the reporter, and patients are informed when they have been involved in an adverse event. PSRS involves the least follow-up—it was built as a complement to the NCPS and is used primarily for learning purposes; however, reporters do receive a confirmation by mail that their report has been received. Tabular Information All of this information is broken out in more detail in the tables. Table C–1a includes the two CDC-managed systems and the joint FDA- and CDC-managed VAERS. Table C–1b includes the FDA-managed MedWatch system, CMS’s MPSMS, and the MHS PSP. Table C–1c includes the two VA-managed systems.
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Patient Safety: Achieving a New Standard for Care TABLE C–1a Selected Examples of Federal Patient Safety/Health Care Reporting and Surveillance Systems Federal Agency CDC Name of System National Nosocomial Infections Surveillance Systema Type of System Surveillance. History of reporting/surveillance system The NNIS system is a cooperative effort that began in 1970 between CDC and participating hospitals. The system is used to describe the epidemiology of nosocomial infections and antimicrobial resistance trends. Voluntary or mandatory Voluntary. Reportable events/events monitored The NNIS system has two components: (1) nosocomial infections and (2) antimicrobial use and resistance (AUR). In two situations, an infection is considered nosocomial: (1) infection that is acquired in the hospital but does not become evident until after hospital discharge and (2) infection in a neonate that results from passing through the birth canal. There are two special situations when an infection is NOT considered nosocomial: (1) infection associated with a complication or extension of infection already present on admission, unless a change in pathogen or symptoms strongly suggests the acquisition of a new infection, and (2) in an infant an infection known or proved to have been acquired transplacentally and evident 48 hours or less after birth. aInformation on the NNIS system has been obtained from the following sources: Gaynes (1998), Gaynes and Horan (1999), Gaynes and Solomon (1996), Horan and Emori (1998), Richards et al. (2001), Centers for Disease Control and Prevention (2002).
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Patient Safety: Achieving a New Standard for Care CDC Joint FDA/CDC Dialysis Surveillance Networkb Vaccine Adverse Event Report Systemc Surveillance. Reporting. DSN is a national surveillance system for monitoring bloodstream and vascular infections. It was initiated by CDC in August 1999. The National Childhood Vaccine Injury Act (NCVIA) of 1986 mandated the reporting of certain adverse events following vaccination to help ensure the safety of vaccines distributed in the United States. This act led to the establishment of VAERS in November 1990 by the U.S. Department of Health and Human Services. Voluntary. Mandatory for health professionals and manufacturers to report events listed in the Reportable Events Table. Voluntary for health professionals and consumers to report reactions to other vaccines not listed in the Reportable Events Table. Only chronic hemodialysis patients are included. Reportable events are significant bacterial infections resulting from hemodialysis. These events are identified because they include either a hospitalization or in-unit intravenous (IV) antimicrobial start. The NCVIA requires reporting of: Any event set forth in the Reportable Events Table that occurs within a specified time period (these are summarized below). Any event listed in the manufacturer’s package insert as a contraindication to subsequent doses. Vaccine/toxoid =Tetanus in any combination Anaphylaxis or anaphylactic shock Brachial neuritis bInformation on DSN has been obtained from the following sources: Centers for Disease Control and Prevention (1999), Centers for Disease Control and Prevention: Hospital Infections Program (2000). cInformation on VAERS has been obtained from the following sources: Food and Drug Administration (1999, 2001b).
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Patient Safety: Achieving a New Standard for Care Federal Agency CDC Name of System National Nosocomial Infections Surveillance Systema The two conditions that are NOT infections include: (1) colonization or the presence of microorganisms that are not causing adverse clinical signs or symptoms, and (2) inflammation that results from tissue response to injury or stimulation by noninfectious agents, such as chemicals. The AUR surveillance system requires, for a range of pathogens, the reporting of antimicrobial resistance. Each pathogen requires data for different antimicrobial agents. The pathogens are Staphylococcus aureus, coagulase-negative staphylococci, Enterococcus species, Streptococcus pneumoniae, Escherichia coli, Klebsiella pneumoniae, Enterobacter species, and Pseudomonas aeruginosa.
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Patient Safety: Achieving a New Standard for Care CDC Joint FDA/CDC Dialysis Surveillance Networkb Vaccine Adverse Event Report Systemc Any sequela (including death) of above events Events described in manufacturer’s package insert as contraindications to additional doses of vaccine Vaccine/toxoid = Pertussis in any combination Anaphylaxis or anaphylactic shock Encephalopathy (or encephalitis) Any sequela (including death) of above events Events described in manufacturer’s package insert as contraindications to additional doses of vaccine Vaccine/toxoid = Measles, mumps, and rubella in any combination Same events as pertussis in any combination Vaccine/toxoid = Rubella in any combination Chronic arthritis Any sequela (including death) of above events Events described in manufacturer’s package insert as contraindications to additional doses of vaccine Vaccine/toxoid = Inactivated Polio (IPV) Anaphylaxis or anaphylactic shock Any sequela (including death) of above events Events described in manufacturer’s package insert as contraindications to additional doses of vaccine Vaccine/toxoid = Hepatitis B Same events as IPV
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Patient Safety: Achieving a New Standard for Care Federal Agency CDC Name of System National Nosocomial Infections Surveillance Systema Classification system and/or severity index All infections are categorized into major and specific infection sites, using standard CDC definitions that include laboratory and clinical criteria. Surgical site infection roles are stratified by a risk index based on wound classification,duration of operation,and the American Society of Anesthiologists severity assessment score. Reporting time frame Not applicable—surveillance is ongoing.
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Patient Safety: Achieving a New Standard for Care CDC Joint FDA/CDC Dialysis Surveillance Networkb Vaccine Adverse Event Report Systemc Vaccine/toxoid = Hemophilus influenzae type b (polysaccharide) Early-onset Hib disease Any sequela (including death) of above events Events described in manufacturer’s package insert as contraindications to additional doses of vaccine Vaccine/toxoid = Hemophilus influenzae type b (conjugate) Events described in manufacturer’s package insert as contraindications to additional doses of vaccine Vaccine/toxoid = Varicella Same events as Hemophilus influenzae type b (conjugate) Vaccine/toxoid = Rotavirus Same events as Hemophilus influenzae type b (conjugate) Vaccine/toxoid = Pneumococcal conjugate Same events as Hemophilus influenzae type b (conjugate) Events are classified initially according to outcome: hospitalization or in-unit IV antimicrobial start. They are further classified according to the vascular accesses that the patient has, the problems that led to hospitalization or in-unit IV antimicrobial start, and the results of blood cultures done in the hospital or dialysis unit. No severity index. Reported adverse events that are listed on the Reportable Events Table are categorized by type of vaccine, to the extent possible. No severity index, but outcomes are recorded. Not applicable—surveillance is ongoing. For consumers: No restriction on the time lapse between the vaccination and the start of the event or between the event and the time the report is made.
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Patient Safety: Achieving a New Standard for Care Name of System Medical Event Reporting System for Transfusion Medicinea System owner or manager Primarily based at Columbia University (under a grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health). based on the theories of case-based reasoning (CBR) and searches the database for similar cases based on weighted form fields. Users may analyze and interpret both their local data and the central aggregate database using preprogrammed online reports or by downloading their sites’ data into Excel or Access. This allows for benchmarking. The local database is evaluated regularly to assess the effectiveness of the system and impact of corrective actions. After evaluation, regular feedback about the system to all staff and immediate feedback to incident reporters are strongly recommended. The central database is evaluated for trends and analyzed using data mining software. Other information collected through the system None. Confidentiality issues Event reporting is completely confidential and not linked to employee performance assessment. Relationship with other reporting systems Any events defined by the FDA as reportable are transmitted to the FDA’s Blood Products Deviation (BPD) system. Relationships with JCAHO/Medicare certification For JCAHO-accredited organizations: All sentinel events meeting the JCAHO definition of a reviewable sentinel event can be reported to JCAHO (this is determined at the local level).
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Patient Safety: Achieving a New Standard for Care Medication Errors Reporting Programb MedMARxc United States Pharmacopeia United States Pharmacopeia activities and pharmacy and therapeutics committee activities. 2. They can do comparative analyses against similar institutions. 3. Eventually, they will be able to use MedMARx for benchmarking. None. None. Although reporters provide their contact information, they can require that their identities be kept anonymous when the reports are forwarded to ISMP, the FDA, the manufacturer, and other persons requesting a copy of their reports. Reports are anonymous, but randomly assigned facility IDs (each facility only knows its own ID) are used to group the reports. These IDs are associated with facility profiles, which allow each facility to compare its information with similar facilities without knowing the actual identities of those facilities. All information is forwarded to the FDA MedWatch system. All sentinel events meeting the JCAHO definition of reviewable sentinel event can be downloaded into a JCAHO template located in MedMARx.
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Patient Safety: Achieving a New Standard for Care TABLE C–3b Selected Examples of Private Patient Safety/Health Care Reporting and Surveillance Systems Name of System Sentinel Event Policya System Owner or Manager Joint Commission on Accreditation of Healthcare Organizations Type of system Reporting. History of reporting/ surveillance system JCAHO has been involved in patient safety reporting systems since 1995. In 1996, the Sentinel Event Policy was implemented. This was followed by the establishment of a Sentinel Event Database and the implementation of sentinel event standards. These standards were first included in the Joint Commission accreditation manual in 1999, and in July 2001 additional patient safety standards went into effect for hospitals. Voluntary or mandatory Voluntary; organizations are “encouraged, but not required” to report any sentinel event meeting the JCAHO criteria for reviewable sentinel events (see below). If the Joint Commission becomes aware of a reviewable sentinel event that occurred at an accredited organization, whether self-reported or not, that organization must prepare and submit an RCA and action plan to JCAHO or otherwise provide evidence of having completed a thorough and credible RCA and action plan (see “Method of reporting” below for available alternatives). Reportable events/ events monitored A sentinel event is defined as an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Note that the definition does include ”near misses.” Such events are called “sentinel” because they signal the need for immediate investigation and response. The following events are defined as reviewable sentinel events and should be reported to JCAHO: 1. An event that has resulted in an unanticipated death or major permanent loss of function, not related to the natural course of the patient’s illness or underlying condition or aInformation on the JCAHO Sentinel Event Policy has been obtained from the following sources: Joint Commission on Accreditation of Healthcare Organizations (2002a, b) and personal communication, P. Schyve, JCAHO, 2002.
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Patient Safety: Achieving a New Standard for Care Name of System Sentinel Event Policya System Owner or Manager Joint Commission on Accreditation of Healthcare Organizations 2. An event that is one of the following (even if the outcome was not death or major permanent loss of function): (a) Suicide of a patient in a setting where the patient receives round-the-clock care (e.g., hospital, residential treatment center, crisis stabilization center), (b) Infant abduction or discharge to the wrong family, (c) Rape, (d) Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities, (e) Surgery on the wrong patient or wrong body part. Note: This subset of events excludes “near-miss” sentinel events. Classification system and/or severity (risk assessment) index No standard system. Leadership standard (LD.5.1) requires each accredited organization to define sentinel event for its own purposes in establishing mechanisms to identify, report, and manage these events. At a minimum, an organization’s definition must include those events defined as reviewable sentinel events by JCAHO; however, they have latitude in setting more specific parameters to define “unexpected,” “serious,” and “the risk thereof.” Reporting time frame If the Joint Commission becomes aware (through voluntary self-reporting or otherwise) of a reviewable sentinel event that occurred at an accredited organization, that organization must prepare and submit an RCA and action plan to JCAHO within 45 calendar days of the event or of becoming aware of the event. If an organization fails to submit or make available an acceptable RCA and action plan within 45 days, the Accreditation Committee can place the organization on Accreditation Watch.b An organization on Accreditation Watch has an additional 15 days to submit an acceptable RCA and action plan. Data collected: Format and summary There is a form that organizations may use when reporting the occurrence of a sentinel event. The information collected on this form includes name and address of organization, date of incident, textual summary of incident (which should not include bAccreditation Watch status is considered information that can be publicly disclosed.
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Patient Safety: Achieving a New Standard for Care Name of System Sentinel Event Policya System Owner or Manager Joint Commission on Accreditation of Healthcare Organizations names of patients, caregivers, or other individuals involved in the event), method for sharing event-related information (via mail or one of the four alternatives—see “Method of reporting” below for more detail on these alternatives), and contact information for the event reporter. There are no standard formats for RCAs and action plans; they may be conducted according to each organization’s locally accepted method. However, JCAHO does require that RCAs be thorough and credible before they will accept them (see “Follow-up” below for more detail on these requirements). In addition, JCAHO does provide a sample framework for an RCA and action plan, which may be used as an aid for organizing the steps in RCAs. The JCAHO Sentinel Event Database has certain required data elements that are abstracted from RCAs, action plans, and follow-up activities. The three major categories of data elements included are sentinel event data, root-cause data, and risk reduction data. Method of reporting The primary means of submitting RCAs and action plans to JCAHO is via the mail. JCAHO then acknowledges receipt of the information and, once it has been processed, will return the original RCA and destroy all remaining copies of the document. Alternative 1: The organization can schedule an appointment to personally bring the RCA and other sentinel event-related documents to the JCAHO headquarters building for review by JCAHO staff, then leave with all of these documents still in the organization’s possession. Alternative 2: The organization can request an on-site review of the RCA and other sentinel event–related documents by a JCAHO surveyor. This surveyor can then review these documents and interview staff. No copy of the RCA will be retained by JCAHO. Alternative 3: The organization can request an on-site visit by a JCAHO surveyor to conduct interviews and review relevant documentation to obtain information about the process and findings of the RCA and action plan, without actually reviewing the RCA documents. No copy of the RCA will be requested or retained by JCAHO.
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Patient Safety: Achieving a New Standard for Care Name of System Sentinel Event Policya System Owner or Manager Joint Commission on Accreditation of Healthcare Organizations Alternative 4: The organization can request an on-site review of its process for responding to a sentinel event and the relevant policies and procedures preceding and following the organization’s review of a specific event. This option is to be used in those instances where the organization meets specified criteria respecting the risk of waiving legal protections for RCA information shared with JCAHO. Who reports JCAHO-accredited organizations are self-reporting often through the quality improvement coordinator, sometimes the chief executive officer or another senior executive, or the risk manager. Also, JCAHO can be made aware of sentinel events through patients and their families, employees of the accredited organizations, or the media. RCA trigger All events defined by the accredited organization as sentinel events, which will, at a minimum, include JCAHO reviewable sentinel events, require an RCA. Follow-up (including RCA) Each organization can conduct RCAs and develop action plans according to its own locally accepted methods. JCAHO then determines if the RCA and action plan are acceptable. An RCA will be considered acceptable for accreditation purposes if it has the following characteristics: The analysis focuses primarily on systems and processes, not individual performance. The analysis progresses from special causes in clinical processes to common causes in organizational processes. The analysis repeatedly digs deeper by asking “Why?” Then, when answered, “Why?” again, and so on. The analysis identifies changes that could be made in systems and processes—either through redesign or development of new systems or processes—that would reduce the risk of such events occurring in the future. The analysis is thorough and credible. To be thorough, the RCA must include: A determination of the human and other factors most directly
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Patient Safety: Achieving a New Standard for Care Name of System Sentinel Event Policya System Owner or Manager Joint Commission on Accreditation of Healthcare Organizations associated with the sentinel event and the process(es) and systems related to its occurrence; Analysis of the underlying systems and processes through a series of “Why?” questions to determine where redesign might reduce risk; Inquiry into all areas appropriate to the specific type of event as described in the current edition of Minimum Scope of Review of Root Cause Analysis; Identification of risk points and their potential contributions to this type of event; and A determination of potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future or a determination, after analysis, that no such improvement opportunities exist. To be credible, the RCA must: Include participation by the leadership of the organization and by the individuals most closely involved in the processes and systems under review; Be internally consistent; Provide an explanation for all findings of “not applicable” or “no problem”; and Include consideration of any relevant literature. An action plan will be considered acceptable if it: Identifies changes that can be implemented to reduce risk or formulates a rationale for not undertaking such changes; and Where improvement actions are planned, identifies who is responsible for implementation, when the action will be implemented, and how the effectiveness of the actions will be evaluated. After the RCA and action plan are accepted by JCAHO, an Official Accreditation Decision Report is issued. This report: Reflects JCAHO’s determination to continue or modify the organization’s current accreditation status and to terminate the Accreditation Watch, if previously assigned; and Assigns an appropriate follow-up activity, typically a written progress report or follow-up visit, to be conducted within 6 months.
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Patient Safety: Achieving a New Standard for Care Name of System Sentinel Event Policya System Owner or Manager Joint Commission on Accreditation of Healthcare Organizations Follow-up activities are conducted when the organization believes it can demonstrate effective implementation, but no later than 6 months following receipt of the Official Accreditation Decision Report. Other information collected through the system None. Confidentiality issues Handling of any submitted RCA and action plan is restricted to specially trained staff in accordance with procedures designed to protect the confidentiality of the documents. Upon completing the review of any submitted RCA and action plan and abstracting the required data elements for the Joint Commission’s Sentinel Event Database: The original RCA documents will be returned to the organization and any copies will be shredded. The action plan resulting from the analysis of the sentinel event will be initially retained to serve as the basis for the follow-up activity. Once the action plan has been implemented to the satisfaction of the Joint Commission, as determined through follow-up activities, the Joint Commission will return the action plan to the organization. Relationship with other reporting systems No direct relationships, but organizations can use other reporting and surveillance systems to facilitate their reporting to JCAHO. However, aggregate data on event characteristics, root causes, and risk reduction strategies contribute to the evidence base for publication of Sentinel Event Alert and the Joint Commission’s patient safety bulletin and for the annual JCAHO National Patient Safety Goals, which are utilized by other organizations. Relationships with JCAHO/Medicare certification Failure to comply with the JCAHO Sentinel Event Policy by accredited organizations can result in being placed on Accreditation Watch or having status changed to Preliminary Non-accreditation or nonaccredited.
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