การศึกษาระบบคุณภาพห้องปฏิบัติการชันสูตรสาธารณสุข ตามมาตรฐานงานเทคนิคการแพทย์ 2551

Abstract

Background: Medical Laboratory of Ministry of Public Health takes roles of diagnosis, treatment, surveillance and control of diseases in responsible area. Laboratory diagnosis must be precise, accurate and reliable. The Thailand

Medical Technology Standard: 2008 is the professional standard, which was established to control the laboratory quality system. During the year 2008 – 2010, this standard was implemented by laboratories in region 3 and 9 to upgrade their laboratory standards to meet the requirements of ISO 15189 laboratory accreditations.

Methods: A retrospective study has been conducted by analyzing self-assessment data between the two consecutive years (2008-2009) from 29 medical laboratories in region 3 and 9 regarding to conformity of laboratory regulation that can be accomplished.

Result: Sixteen out of 29 (55.17%) laboratories gain scores higher than the previous assessment, 4 laboratories (13.79%) received the same scores and the rest of them had lower scores than the previous one. For the improvement of qualitative changes in laboratory performance, 4 of 29 (13.79%) laboratories had improved in quality system level while 22 of 29 (75.86%) laboratories showed no improvement. Furthermore 3 of 29 (10.35%) had lower level of quality system. The standard regulations that could not be completely implemented are examination procedure, internal audit, assuring quality of examination procedure, accommodation and environment condition and organization and management.

Conclusion: It was found that the Thailand Medical Technology Standard: 2008 is appropriate for medical laboratory to systematically employ and continuously follow. Assessing Eastern hospital laboratories revealed that the laboratory quality and performance are precise, accurate and reliable with could enhance laboratory capacity to achieve ISO 15198 standard.