scope:

Foreword

The timely reporting of results that need urgent clinical review is a fundamental responsibility of medical laboratories. This practice is essential for patient safety and is mandated by regulatory and accreditation requirements for laboratories and health care organizations. Laboratory and anatomic pathology results need urgent clinical review when they represent a high risk to patient health and safety. When the results indicate risk of immediately life-threatening conditions, they need to be communicated without delay to a responsible caregiver for urgent patient evaluation and management. GP47 recommends this result category be called "critical-risk" results. In addition, the concept of patient risk can be applied to a broader range of results that may not be immediately lifethreatening, but still represent a risk to patients unless they are clinically evaluated and managed within a specific time frame sooner than would occur through routine reporting. GP47 recommends that this result category be called "significant-risk" results.

Due to the high risk to patient safety and the need for timely communication, the reporting of critical- and significant-risk results typically involves special procedures characterized by:

• Direct, person-to-person communication

• Verification of accurate receipt of information

• Occurrence within clinically appropriate time frames

• Documentation in the patient record

Many regulatory and accreditation organizations require processes for reporting results that need urgent clinical review as well as monitoring systems and quality goals to ensure reporting is timely and effective. Compliance with these regulatory and accreditation requirements is often a focal point during inspections of laboratories and health care organizations.

This guideline defines key processes in the reporting of critical- and significant-risk laboratory results. It recommends processes and procedures that are compliant with regulatory and accreditation requirements and consistent with patient safety best practices.