Implementation of quality control performance criteria and approved guidelines for upgrading of clinical chemistry laboratory procedures in Alexandria University hospitals

The aim of the present work was to assess the quality of work in Clinical Pathology Department, Alexandria Main University Hospital, Egypt; as regards the pre-analytical and analytical phases of testing; for later accreditation. This evaluation was performed using inspection sheets that were designed according to the CAP 2006 recommendations. All checklist questions that could not be answered “yes” were considered deficiencies and had to be corrected before being accredited. The questions were classified into ten groups; each group contained a number of questions concerning one of the pre-analytical and analytical assessment activities. We ranked our results into 4 categories according to the degree of fulfillment. The total number of questions that were answered “no” at the start and the end of the study accounted for 64/101 (63.4%) and 34/101 (33.7%) questions respectively. Most of the deficiencies were detected in the pre-analytical phase of the testing process; the first two checklists were used for the evaluation of this phase. At the start of the study, the degree of requirements fulfillment in checklist I and II were 0% and 21.1% respectively. By the end of the study the degree of fulfillment became, 85.7% and 63.2% respectively. Average number of sample rejection due to different causes was evaluated before and after implementing CAP recommendations; these causes include haemolysis, clotted serum, quantity not sufficient, and lost samples; the percentage of rejected samples before implementing CAP recommendations was 15.8%, 1.81%, 0.70%, and 0.51% respectively, while after implementing CAP recommendations it was 7%, 0.77%, 0.08%, and 0.05%, respectively. We concluded that the presence of standardized protocol for the pre-analytical activities had improved the quality of samples received by the lab, and we also concluded that accreditation allows laboratories to evaluate their performance, their compliance with the requirements of the accrediting association, and their ability to improve the accuracy of the patient results they provide.