ABSTRACT
The total quality management requirements for the performance of hematological investigations. Technical quality control of procedures, internal quality control, has been practiced since the introduction of devices for automated testing. External quality assurance of procedures, proficiency testing, was also soon established. More recently, the concept of total quality management to include the management of laboratory personnel and their environment has been introduced. This includes matters concerned with safety in the laboratory. These measures are applicable to all laboratories, but those handling investigation of patients have particular concerns that extend from turnaround time for emergency tests to ethics concerning the handling of specimens. Most countries have developed standards with regard to quality management, some of which are regulatory, and there are now a number of international standards developed by the International Standards Organization (ISO).444,445
The matters concerned can be summarized as:
Management system requirements Organization and management Quality management system Document control Referral of examinations to other laboratories External services and supplies Control of nonconformities Consultative services and resolution of complaints Preventive actions Corrective actions Quality and technical records Internal audits Management review Resources and technical requirements Personnel Accommodation and environmental conditions Laboratory equipment Preexamination procedures Examination procedures Assuring the quality of examination procedures Postexamination procedures Reporting results
Alterations and amendments to reports Laboratory information systems Ethics in laboratory medicine
Special considerations must be given for laboratories undertaking hematological examinations444a and when point-of-care testing is in operation.
