Patient Safety Achieving a New Standard for Care (2004) / Chapter Skim
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9 Standardized Reporting
9 Standardized Reporting
Pages 279-316
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From page 279... ...
The second section discusses a common set of data standards for patient safety reporting that can enable the aggregation of data from voluntary and state reporting systems, as well as support the establishment of a national patient safety database first called for in To Err Is Human (Institute of Medicine, 2000)
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At the state level, for example, New York and Florida are 2 of 21 states with mandatory requirements for reporting adverse events. The data elements they collect for the most serious adverse events have some areas of commonality: • Similar patient information is collected.
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The remedy for the disparate scenario described above is the development of a common reporting format of domain areas, data elements, and
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The standard report format could be employed for a number of purposes: populating a national patient safety database; meeting the functional requirements for the establishment of patient safety organizations in the private sector as proposed in pending legislation; providing a format easily implemented by those states that have not yet established patient safety reporting systems; and serving as a common format for mapping data across established state reporting systems, as well as to a national database. The data protection and legal considerations that arise in the generation of numerous reports from shared data elements are addressed later in this chapter.
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Data standards, including the standardized report format, should be dynamic and respond to new knowledge in an evolutionary manner while adhering to the basic principles and purposes of standardization. As stated in To Err Is Human, a standardized report format can (1)
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. The reporting format must also be capable of providing information that leads to a greater understanding of the nature of adverse events -- for example, why such events occur, how they are recognized, what the critical control points are along the care continuum, what types of recovery or corrective actions are taken, and the effect on patient outcomes (Cook, 2003)
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• Report all events, including no harm/near misses. • Solicit input from anyone with firsthand information about an event.
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However, the VHA system, like others, does not include "nonreprisal" treatment for intentionally unsafe acts. The parameters shown in Box 9-1 are directly applicable to the development of a generic reporting format for the wide range of adverse events, medical errors, and near misses.
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. The detailed dataset expands the data collection beyond the minimum dataset to include information on the mechanism of the incident, root causes, contributing factors, actions taken, outcome, and consequences to the organization (Australian Patient Safety Foundation, 2003)
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However, from an organizational perspective, it is necessary to evolve from a primary focus on sentinel events to the broader issues of adverse events and near misses. For this purpose, a safety event that would have a high impact on quality improvement needs to be captured, classified, and coded.
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Despite their limitations, the ICD–9/10 CM ECodes are useful as one mechanism for detecting adverse events. The committee recommends additional investment to expand them and to enhance their capacity to capture patient safety information.
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, each employing different data standards depending on the organization and vendor. In 2000, the Anesthesia Patient Safety Foundation (APSF)
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To further efforts toward data standardization, the committee believes that the best method of satisfying the terminology requirements for Phase I of the federal patient safety data integration project is the use of the designated NCVHS core terminology group with mappings to supplemental terminologies. This approach would support research and analysis of data from the national patient safety database and federal reporting systems.
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. The risk assessment is used as a tool to set priorities and identify which areas require root-cause analysis or further attention (Australian Patient Safety Foundation, 2003)
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. The AIMS risk assessment index is based on the VHA model but extends the matrix to 5 × 5, as seen in Table 9-2.
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The committee believes a risk assessment scale should be included in the common patient safety report format. In addition to an RAI, the committee believes that differentiating between probability and preventability is important to the analysis of events.
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. Causal Analysis Once it has been determined that an event is or could have been serious, a root cause analysis (RCA)
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patient outcome as related to the duration, severity, and resource impact of the disease type, injury type, suffering, disability, or death; and (2) consequences for the organization, including immediate and subsequent actions taken, impact in terms of cost, and legal liability (Australian Patient Safety Foundation, 2003)
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and Resource Impact and Risk Rating © 2001 Prof W B Runciman FIGURE 9-1 Generic Reference Model Diagram. 297 SOURCE: Australian Patient Safety Foundation, 2002.
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Use of the Eindhoven model to assess near misses is vital to the identification of causal and recovery factors, providing the new knowledge that can be integrated at the front line of care to develop a more highly reliable system. AHRQ has designated the Eindhoven model as the causal analysis taxonomy for the federal patient safety integration project.
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No Unclassifiable =X FIGURE 9-2 Eindhoven Classification Model: Medical Version. SOURCE: Eindhoven Safety Management Group, 1997.
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300 PATIENT SAFETY TABLE 9-4 Codes Used in Eindhoven Classification Model, Medical Version Category Description Code Latent errors Errors that result from underlying system failures Technical Refers to physical items, such as equipment, physical installations, software, materials, labels, and forms External Technical failures beyond the control and TEX responsibility of the investigating organization Design Failures due to poor design of equipment, TD software, labels, or forms Construction Correct design was not followed accurately TC during construction Materials Material defects not classified under TD or TC TM Organizational External Failures at an organizational level beyond the OEX control and responsibility of the investigating organization Transfer of knowledge Failures resulting from inadequate measures OK taken to ensure that situational or domain specific knowledge or information in transferred to all new or inexperienced staff Protocols/procedures Failures related to the quality and availability OP of the protocols within the department (too complicated, inaccurate, unrealistic, absent, or poorly presented) Management priorities Internal management decisions in which OM safety is relegated to an inferior position in the face of conflicting demands or objectives.
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STANDARDIZED REPORTING 301 TABLE 9-4 Continued Category Description Code Active errors (human) Errors or failures resulting from human behavior External Human failures originating beyond the control HEX and responsibility of the investigating organization Knowledge-based behaviors Knowledge-based errors The inability of an individual to apply existing HKK knowledge to a novel situation Rule-based behaviors Qualifications Incorrect fit between an individual's HRQ qualifications, training, or education and a particular task Coordination Lack of task coordination within a health care HRC team in an organization Verification Failures in the correct and complete HRV assessment of a situation, including relevant conditions of the patient and materials to be sued, before starting the intervention Intervention Failures that result from faulty task planning HRI (selecting the wrong protocol)
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Summary of Domain Areas for a Common Report Format This section has described those elements of a common report format that the committee believes would be most productive in the aggregation and evaluation of adverse events and near misses within the context of a partially or fully integrated health information system. The information to be input into this report format can be derived from the original narratives provided by the reporters of the events and supplemental information from causal analysts.
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Detailed causal analysis -- On the basis of the above information, a decision should be made on whether a formal root-cause analysis should be carried out. The analysis should include examination of the following: • Technical, organizational, and human factors associated with the Eindhoven model to document what happened and why in detail • Recovery factors that can occur at each point for near misses • Corrective actions that were taken to recover from actual incidents • Patient outcome/functional status as a result of the corrective actions taken • Whether a similar case has recently been investigated Lessons learned As stated earlier in this chapter, there is no comprehensive patient safety taxonomy for representing adverse event and near-miss data in the United States, although JCAHO has expressed interest in this concept and has been working on the development of a taxonomy framework.
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AHRQ should play a leadership role in the implementation of the standardized format. To facilitate its adoption, AHRQ could require that the report format and associated data standards be utilized in the agency's ongoing patient safety programs and for population of the national patient safety database.
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From the perspective of health care providers, particularly for physicians who operate independently out of small group offices, use of a common report format should ease the incorporation of a safety program for documenting adverse events and near misses. Likewise, clinicians who operate in various settings with different reporting formats (e.g., nursing homes and home care)
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. The committee believes that AHRQ should also extend a request for proposals for the development of a generic software application of the report format employing the terminologies and data standards presented in this chapter.
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Whereas internal reports must contain highly detailed and often identifiable information, most external reports need contain only deidentified data. For both internal and external reports, standardized report formats would facilitate reuse of the data contained in clinical care systems, use of standardized analysis techniques, and comparative analysis of aggregate data.
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PRIMARY AND SECONDARY USES OF REPORT DATA Information stemming from the proposed patient safety reports, particularly the causal analysis, has both primary and secondary applications in improving the care processes. Most primary uses relate to the feedback loop that supplies data for refining care processes and enhancing decision support tools, while secondary uses include database research into the epidemiology of occurrences, public health surveillance, drug safety surveillance, and other studies (Lowrance, 2002)
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. Review and analysis of patient safety reports on surgical events have led to the development of a specific set of minimum preoperative procedures to be completed days to 1 hour before surgery (i.e., consent form validating the site, laterality, name, and reason for the procedure, plus marking of the site soon before the surgery)
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At present, however, many providers lack the technologies and data standards needed to engage in these programs. The ability to reuse patient data, including safety data, for quality improvement purposes would ease providers' transition to electronic systems while at the same producing immediate gains and reinforcement for collection of the data and follow-up on patient care.
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These taxonomies should encompass the core terminologies identified by NCVHS as central to the NHII and those identified for the AHRQ sponsored project to integrate federal patient safety reporting systems. As organizations migrate to fully integrated health information systems, it should be possible to generate multiple reports automatically using common data elements compatible with the NHII.
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312 PATIENT SAFETY TABLE 9-5 Overview of Child Health Accountability Initiative (CHAI) Medication Safety Project Year 1999 2000 Area of emphasis Pediatric Intensive Care Unit Sedation and Analgesia Description Formed multidisciplinary teams Implemented new reporting form of CHAI centered on rapid improvement Developed standardized data projects in medication errors dictionary Developed new medication error Created medication usage process tracking tools maps Investigated all medication orders Completed (IHI)
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safety measures in technology for data pediatrics. CHAI is working collection using nine toward a goal of national pediatric triggers adoption of the CHAI Tested five to seven new pediatric trigger pediatric-specific triggers methodology and Compared methodology with integration of the triggers other methods of ADE into computerized physician reporting order entry as the industry standard.
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Adelaide, South Australia: Australian Patient Safety Foundation.
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2000. State Reporting of Medical Errors and Adverse Events: Results of a 50-State Survey.
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Comments on Using ICD-9-CM and ICD-10-CM Codes to Identify Medical Errors or Adverse Events. Letter to the Institute of Medicine Committee on Data Standards for Patient Safety.
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