Terrés-Speziale AM

Language: Spanish
References: 0
Page: 125-149
PDF size: 101.93 Kb.

ABSTRACT

Continuous Quality Improvement in the Clinical Laboratory is a management responsibility that demands and involves teamwork. Better labs contribute positively on healthcare and benefit human society. Quality is a relative concept where the main frame is to harmonize customer’s expectations with providers´ specifications on structures, process, and outcome in effective, time efficient and cost effective standards. It is clear that it cannot be improved what it hasn’t been controlled measured, defined and documented. It is also impossible to evaluate the quality of the laboratories without a valid framework in terms of width and depth. After several years of multidisciplinary work that involved the National Health Authorities plus the public social and private sectors on January 13-2000, on the Federal Official Diary NOM-166-SSA1-1997, was published entitled “ Standard for The Organization And Operation of Clinical Laboratories”. The objectives of this obligatory standard and that have to be audited and approved after January 13-2002 are to establish a quality program on each and every laboratory in order to • Provide patients with the best benefits at the minimum costs and risks. • Assure that the analytical data contribute positively on clinical decisions. • Improve systematically the reliability and opportunity of lab results. • Detect deviations opportunely in order to control, avoid and reduce them to the minimum possible level. • Eliminate the unfair competition that certain individuals and organizations practice This Official Mexican Standard makes reference to other four standards that deal with bio-infectious disposables; management of toxic substances on work centers; radioactive substances; plus the labeling of chemicals. Additionally requires the documentation of seven manuals including: 1.Organization. 2. Administrative Procedures. 3. SOP For the Analysis each Test. 4. SOP For Instruments and Analyzers. 5. Guide for Specimen Sampling. 6. Health & Safety. 7. Quality Assurance. Scientific method and medical consultation demand accurate data and information management in order to establish valid conclusions. This is analog to diagnosis first, prior to treatment and prognosis. The utilization of the proposed checklist that has been developed according to CAP and NCCLS methodology will allow a standardized audit for clinical labs. It seems clear that if all the labs in Mexico utilize this tool we will be able to achieve a significative advance on the quality improvement challenges, while we develop and consolidate a National Program of Accredited Institutions that will be capable to certify the quality of their affiliated clinical laboratories.