Clinical and Laboratory Standards Institute document GP47—Management of Critical- and Significant-Risk Results describes systems for effective communication of laboratory results that need urgent clinical review. These laboratory results signify risk of major adverse patient outcomes. Therefore, mechanisms for their rapid identification and timely reporting are essential for patient safety. This guideline emphasizes management responsibilities for the development of the policy, the process, procedures, job descriptions, and monitoring systems that promote effective, timely reporting and compliance with regulatory requirements.

This guideline is intended for laboratory directors, managers, and personnel who develop and implement policies and processes for reporting laboratory results that need urgent clinical review. This guideline is also intended for health care administrators who oversee compliance with regulatory and accreditation requirements and clinical practice standards related to patient safety. This information is aligned with standards existing at the time of publication. This guideline is appropriate for all health care environments that conduct laboratory examinations for patient care. Materials are appropriate for laboratories associated with hospitals, clinics, or physician offices as well as independent referral laboratories. The recommendations cover every laboratory discipline and pertain to medical laboratories of every size, scope, and complexity, including point-of-care testing sites. 

The process for reporting critical- and significant-risk results is emphasized. The document also describes evidence-based quality metrics and methods to monitor the effectiveness of the reporting process. Common organizational challenges to reporting these laboratory results, and new approaches that apply informatics to make the process more effective and efficient are discussed. The appendixes include a sample policy, sample forms, specific information for specialty laboratories, and a sample flow chart for an escalation process. A summary of commonly reported critical-and significant-risk results, which are compliant with regulatory and accreditation requirements, is provided for organizations to consider for use. Because no single approach applies to every health care environment, organizations are encouraged to modify their policy and processes to reflect the clinical needs of their patient populations. 

This guideline does not cover the reporting of results from other diagnostic services such as radiology or cardiology. However, the general recommendations may be relevant to these services. In addition, this document does not focus in depth on the reporting of routine laboratory results; however, organizations should recognize that a breakdown in the receipt and follow-up of all result categories may also be a source of patient harm and medicolegal actions.