Improving Patient Safety Through Risk Management

From October 21-27 we celebrate Healthcare Quality Week (HQW), brought to you by the National Association for Healthcare Quality (NAHQ). Implementing a quality management system (QMS) in the laboratory is one important way to improve health care quality. A QMS in the lab can help ensure patient safety and risk management principle application, as well as help prepare a lab for accreditation.

ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements for medical laboratories; requirements that the lab often must follow in preparation for accreditation. 

According to ISO 15189, risk management is a planned process that is part of preventive actions and corrective actions. Preventive actions and corrective actions can be more effectively directed when they are based upon information that is well-organized. The framework of risk management can be described as consisting of the following steps:

1. a) planning for risk,
2. b) identifying risk and its impacts,
3. c) developing risk-handling strategies, and
4. d) monitoring for risk control.¹

These steps are consistent with the management requirements described in ISO 15189, including identifying and controlling non-conformities, establishing preventive actions and corrective actions, carrying out internal audits and management reviews, and implementing continual improvement.¹

CLSI’s accreditation crosswalks are provided free of charge and can help walk your lab through the accreditation requirements set forth in ISO 15189. For more information visit https://clsi.org/standards/products/crosswalks/accreditation-crosswalks/.

 

Reference

1 ISO. Medical laboratories – Particular requirements for quality and competence. ISO 15189. Geneva, Switzerland: International Organization for Standardization; 2007.