TAG:
management systems
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…
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…
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…
Labs Need to Respond To Inaccurate Results
CEO SUMMARY: What does a lab do when it discovers that it has reported inaccurate test results? In 2004, a turnaround team arrived at the laboratory of Maryland General Hospital in Baltimore to deal with the consequences of a failed infectious disease testing program. For about t…
2008’s Top Ten Lab Stories Lacked Disruptive Impact
CEO SUMMARY: For the first time in recent memory, a year has passed without major tumult or disruptive change in the laboratory industry. Our list of the Top Ten Most Important Stories of 2008 reflects a rather quiet year when compared to most years of this decade. Howeve…
Current Review of CLIA Standards Intended to Address Laboratory PT
EFFORTS ARE UNDER WAY TO REVIEW existing requirements for laboratory certification under the federal Clinical Laboratory Improvement Act (CLIA). CLIA legislation was a response by Congress to widely-publicized failings in the quality and performance of certain cytology and office laboratories during …
Quality Management Systems (QMS) & Healthcare
OFF THE RADAR SCREEN OF THE LABORATORY INDUSTRY is an evolving management approach that gives unity to the mishmash of quality improvement tools that carry a variety of names, but have several common attributes. Soon lab directors and pathologists will be quite familiar with the concept of the “qu…
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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