TAG:
iso standards
ARUP Laboratories Earns CAP’s ISO 15189 Accreditation
CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitmen…
Henry Ford Health System Laboratory Division Combines Lean with ISO 15189
CEO SUMMARY: As healthcare transitions away from fee-for-service payment and adopts new models of reimbursement, every clinical lab will need to deliver more value with its lab testing services. At Henry Ford Health System in Detroit, the laboratory division has blazed a path of improving…
Henry Ford Health System Labs Show How Lean Methodology in Healthcare Increases Revenues
EXECUTIVE SUMMARY: Here’s a major accomplishment by the lab division of a nationally-recognized health system that has gone unreported until this DARK REPORT intelligence briefing. This article explains how using the quality management system of ISO 15189 and the Lean methodology in …
CMS Gives Deemed Status to A2LA under CLIA Law
CEO SUMMARY: Quietly published in the March 25 issue of the Federal Register was a notice that CMS had granted deeming authority for CLIA to the American Association for Laboratory Accreditation (A2LA). This action gives laboratories in the United States a new choice to meet the accredita…
ISO 15189 Accreditation Earned by Spectra Labs
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. …
ISO 15189 Accreditation Requires Specific Steps For Global Recognition
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…
Explaining Certification Versus Accreditation
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 clinic…
Third Laboratory Earns ISO 15189 Accreditation
CEO SUMMARY: In June, the laboratory at Blanchard Valley Hospital became third in the nation to be accredited to ISO 15189:2007. The 150-bed acute facility in Findlay, Ohio, is the only hospital laboratory of its size to achieve accreditation to the ISO 15189 standard. Implementi…
Accreditation with DNV Helps Hospital Raise Inpatient Volume
CEO SUMMARY: In Utica, New York, 201-bed St. Elizabeth Medical Center was the first hospital in New York State and one of the first five hospitals nationwide to meet the new accreditation standard from DNV Healthcare, of Cincinnati, Ohio. St. Elizabeth administrators credit use o…
Quest’s Deficiencies Trigger QA/QC Questions
CEO SUMMARY: Experts in laboratory QA/QC and proficiency testing (PT) are following the news that Quest Diagnostics admitted to an 18-month problem with lab test accuracy in its home brew Vitamin 25(OH) D assay. It is recognized as a major failure in the existing system of labora…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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