COLA also has a requirement to comply with CLIA regulations regarding corrective actions. The COLA Laboratory Accreditation Manual* details an incident management plan as part of the evaluation of quality assessment, stating that:
"The laboratory must establish policies and procedures and document their use in managing incidents, particularly those that caused or may potentially cause death or serious injury to patients or laboratory staff. An incident management plan (IMP) provides the structure for these activities. The goal is to identify, learn from, and prevent such incidents from occurring.
An incident is defined as an event that results in, or has the potential to result in, death, or serious injury for patients or laboratory staff. For example, an improperly labeled specimen could have serious consequences.
Incidents may be first identified as part of a QA review conducted by the laboratory. This is not to say that every issue identified in a QA review requires an incident report. The QA review may reveal instances of noncompliance with laboratory policies that, if left uncorrected, could lead to an incident. The intent of these criteria is to focus attention on the most serious consequences and outcomes that may occur as a result of laboratory activities associated with patient diagnosis, care, and treatment."
Also note that COLA does not use the specific term “CAPA” in its evaluation of quality assessment, yet the essential components of the process are similar.
*COLA Accreditation Program. COLA Laboratory Accreditation Manual. Columbia, MD: March 2022.
