Laboratory of Pathology - Staff

Occurrence Reporting Policy

Exceptional events related to patient care, protocol implementation, and service delivery are identified and characterized using the NIH Clinical Center (CC) Occurrence Reporting System (ORS), the Safety Tracking and Reporting System (STARS), which is a confidential, non-punitive mechanism to collect information and communicate information to:

• identify clinical and operational opportunities for improvement;

• identify adverse sentinel events;

• identify instances of exceptional patient care and service delivery;

• collect epidemiologic data regarding occurrences;

• establish a database for analysis and tracking of occurrences;

• provide data to drive performance improvement activities;

• identify reportable events for reporting under the Safe Medical Devices Act.

Use the following definitions as guidelines to determine which types of events should be reported using the ORS.

Occurrence: Any event identified as exceptional by practitioners and staff. This includes, but is not limited to, events:

• not consistent with routine safe operations and practices of the hospital;

• not a natural or expected consequence of a patient’s disease process or clinical research protocol;

• that are considered “near misses” but pose a potential for adverse outcomes;

• that result in exceptional quality of patient care or service delivery.

Occurrence reporting and analysis are intended to prevent damage/risk from occurring, to reduce damage when adverse events have already occurred, and to prevent future adverse events. See  Medical Administrative Series, M88-3  for more details and procedures for reporting an occurrence. A password and training on the ORS is required to initiate a report. The Clinical Laboratory Manager can initiate a report for anyone who does not yet have a password for using the system.

Note: Printing or distribution of hard copies of individual occurrence reports or of summary documents that contain occurrence-specific information is strictly limited to instance when the documents will facilitate formal discussions at peer review or clinical quality meetings. If hard copies are used for this purpose, the copies will be numbered for tracking purposes, collected at the end of each peer review/clinical quality meeting, and destroyed after the meeting.

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