Quality management systems (QMS) have made inroads in some of the organizations that accredit clinical laboratories in the United States to the requirements of CLIA. Last month, COLA of Columbia, Maryland, acknowledged that it had recertified to the standards of ISO 9001: 2008. The recertification was obtained through the British Standards Institute. COLA earned its
Tag: international accreditation
Globalization of laboratory medicine continues to move forward. Two recent examples illustrate this trend. Earlier this month, the University of Pittsburgh Medical Center (UPMC) announced that it had entered into an agreement with the Citizens Hospital of Hyderabad, India, to form a clinical pathology laboratory in that city. The laboratory will be located on the
CEO SUMMARY: Spectra Laboratories Inc., recently announced that it had earned accreditation to the ISO 15189:2007 standard, following an assessment by a team from the Association for Laboratory Accreditation (A2LA). Spectra is a high-volume laboratory that serves renal patients. It also provides clinical trial testing for pharmaceutical companies. Spectra officials stated that the laboratory wanted
CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical laboratories based on the ISO 9001 quality management system.
CEO SUMMARY: Early signs are that the quality management systems (QMS) most likely to find favor with hospitals and clinical laboratories in the United States will be those that meet standards developed by the International Organization for Standardization (ISO). Many hospitals and clinical labs are considering adopting ISO 9001 or ISO 15189, respectively. As they
CEO SUMMARY: Volunteers for the Clinical and Laboratory Standards Institute (CLSI) are in the midst of an 18-month project to help five state-run medical labs in Tanzania gain ISO 15189 accreditation. The project shows how labs in Africa and other countries are moving to adopt international accreditation standards. A growing number of countries, including Australia, Germany, France, and Canada,