TAG:
quality management
Quality Strategy Earns Honor for SD Laboratory
CEO SUMMARY: Here’s a new lab product launch with a surprise twist. Upon earning FDA clearance for its new HIV Ag/Ab Combo Assay this spring, Abbott Diagnostics selected a hospital laboratory in Sioux Falls, South Dakota, to be the nation’s first clinical lab to offer the ass…
Halfpenny Technologies Buys Laboratory Management Services
TO BROADEN ITS CAPABILITIES in handling laboratory test data, Halfpenny Technologies, Inc., announced the acquisition of Laboratory Management Services (LMS) of Hauppauge, New York, earlier this month. Halfpenny seems to be particularly interested in the informatics…
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…
Serious Problems Plague Newfoundland Laboratory
CEO SUMMARY: Newfoundland’s St. John laboratory was rocked by revelations in February that its cyclosporine testing was flawed, exposing patients to the harmful affects from inappropriately high doses of the immunosuppressant drug. Within weeks of this news, the Chief of Laboratory Medi…
Ireland Is Restructuring National Lab Test System
CEO SUMMARY: Working from a consultant’s report and recommendations based on studies dating back to 2006 and 2007, Ireland’s Health Service Executive is moving forward to effect a comprehensive reconfiguration of clinical laboratory testing across the nation. This ma…
New Clinical Lab Trends To Shape Events in 2010
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
DNV Offers Accreditation For Both CMS and ISO
CEO SUMMARY: For about a year, hospitals and health systems have had a new choice for meeting the Medicare Conditions of Participation. This new choice is Det Norske Veritas (DNV). Because DNV offers a dual process for achieving Medicare accreditation and ISO 9001 certification, it brings…
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…
Expert Says Time is Now For Labs to Adopt QMS
CEO SUMMARY: Laboratories in the United States are knowledgeable about the use of quality control (QC) and quality assurance (QA) programs. But QC and QA represent only two small parts of a comprehensive quality management system (QMS), says Lucia Berte, an expert in lab quality. One bene…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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