#06-5558 Accrd Manual V7 - COLA

CRITERIA FOR QUALITY LABORATORY PERFORMANCEQA 19 RAre records kept of complaints about the laboratory and the corrective actions taken concerning these complaints?QA 20As with all laboratory activities, documentation is necessary.E20.1Has the laboratory developed and implemented written policy and procedures to identify, evaluate, manage,and correct any incidents, resulting from Non-compliance with stated policies and procedures?20.2Does the laboratory have procedures for the identification, evaluation, management, and correction of anyunexpected event which has caused, or has the potential to cause, death or serious injury to patients or laboratorystaff?The laboratory must establish policies and procedures and document their use in managing incidents, particularlythose that caused or may potentially cause death or serious injury to patients or laboratory staff.The goal is to identify, learn from, and prevent such incidents from occurring.Incidents may be first identified as part of a QA review conducted by the laboratory. This is not to say thatevery issue identified in a QA review requires an incident report. The QA review may reveal information aboutNon-compliances with laboratory policies that if left uncorrected could lead to an incident. The intent of thiscriterion is to focus attention on the most serious consequences and outcomes that may occur as a result oflaboratory activities associated with patient diagnosis, care, and treatment.A series of examples of laboratory incidents are listed below. ·• laboratory errors (incorrect test results reported leading to misdiagnosis or improper treatment OR wrongtest performed on wrong patient delaying diagnosis or treatment)• accident/injury (reagent spill causes staff member to fall, improper disposal of waste materials causesinjury to staff or patients, employee needle stick as result of phlebotomy) ·• complaint (patient complains of excessive pain, burning, numbness or tingling during/after phlebotomythat may indicate injury from the phlebotomy procedure)• Recognized systemic non-compliance with stated policies and procedures of the laboratory that has a significantnegative impact on the accuracy and reliability of test results ultimately affecting patient outcomesor staff safety.60. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org