Question

How does administrative and clinical standard-reports differ? Classify and provide some examples as an administrative or clinical standard report.

Answer 1

At present, there is no agreement on a common set of data elements for representing patient safety information, much less specification of allowable values for those elements. Each entity self-determines the content of its reports; some even develop their own terminology to represent the information. 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.

Similar information is collected on the time/location of the incident.

Each requires a description of the occurrence and analysis of its root causes.

Each requires a description of the corrective actions taken.

Only one health care data standard, the International Classification of Diseases, Ninth Edition (ICD-9), Clinical Modification (CM), is used by each to identify the diagnosis and procedures associated with the event (Rosenthal et al., 2000).

However, each state has developed its own taxonomy for classifying actual events. The New York Patient Occurrence Reporting and Tracking System (NYPORTS) works within the broad categories of statutorily defined reportable incidents. The system makes use of a detailed list of 54 reportable codes with “includes” and “excludes,” organized by type of event, to promote greater consistency among state hospitals (Rosenthal et al., 2001). Florida, on the other hand, divides the events into two categories—those that must be reported within 15 days and on an annual basis (Rosenthal et al., 2001). Each category includes four or five broad types of events to be reported. Another important difference is that the New York system has a set of questions designed specifically for medication errors, a known major adverse event category; the Florida system does not. The differences among the 15 state patient safety systems are even more pronounced.

The following “real world” example further illustrates the problem with numerous disparate data elements for documenting an adverse event. If an individual suffered a serious adverse drug event (ADE) while in a New York hospital, the clinician would first file a report internally for review by the designated hospital representative. A second report would be filed with the New York State Department of Health through NYPORTS. Another third report could be voluntarily submitted to the Food and Drug Administration (FDA), either through the FDA MedWatch reporting system or through private-sector organizations such as the United States Pharmacopia (USP), to inform the FDA of potential serious problems with the drug. Adding further to the burden of disparate and multiple methods for representing an ADE are the voluntary reporting requirements of the hospitals' accrediting organization, the Joint Commission for Accreditation of Healthcare Organizations (JCAHO), whose proposed taxonomy provides yet another dataset for classifying and reporting such events. Already this example involves four different reports with varying data elements for the same ADE.

In the case of the FDA, reports are submitted to support the agency's regulatory obligations for postmarket surveillance of drugs marketed in the United States, particularly those associated with ADEs. To this end, the organization needs the capability to analyze and compare the ADEs occurring during the clinical trial process with those experienced in clinical practice. However, the FDA uses one terminology, MedDRA, for representation of ADEs experienced by patients during clinical trials and documentation in the manufacturer's dossier for regulatory approval, and another in its MedWatch reporting system. The agency also accepts data from private-sector organizations using different data standards. Thus, for the FDA alone, the data related to one particular ADE is represented by three different data sources. More importantly, the data from clinical trials and postmarket surveillance cannot be compared without costly mapping of the terms among the different taxonomies.

An additional consideration relates to the ability to share and compare data in integrated systems. For example, a clinician who wanted to conduct an analysis of or research on ADE reports compared with events detected and/or prevented with various decision support systems (e.g., pharmacy systems, computerized physician order entry, bar-code medication administration) could not do so without common methods for representing the most basic ADE data (e.g., drug involved, type of event, route of administration, dosage). The ability to compare the factors contributing to an ADE among systems would add to the knowledge and understanding of events. It would also provide a common reference point for classifying event data derived from other sources (e.g., malpractice claims, complaints, claims attachments) and different health care settings (e.g., primary care, inpatient, nursing home). However, such analysis cannot be undertaken without a common language.

The remedy for the disparate scenario described above is the development of a common reporting format of domain areas, data elements, and terminologies that would serve as a common language for reporting, research, and analysis on patient safety. The format would be able to accommodate the rich text of narrative reports that will likely remain the mainstay of patient safety reporting. Common data standards would be used to make the information comparable to the patient safety data extracted from clinical information systems and electronic health record systems (EHRs) such as that from automatic trigger systems. With the common format, health care organizations would experience less burden in fulfilling both data capture and reporting requirements.

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