TAG:
quality control
Root Cause Analysis Used To Find Source of Errors
CEO SUMMARY: It is a reminder that today’s sophisticated laboratory test systems still have the potential to malfunction in unexpected ways. This spring, following installation and validation of a new chemistry instrument, one Canadian hospital laboratory quickly recognized that a serie…
Pathologists in China, U.S. Linked By Digital Pathology
CEO Summary: It is one of the first clinical collaborations of this type to be anchored by use of digital pathology. Pathologists at the medical schools of the Second Affiliated Hospital of Zhejiang University in Hangzhou, China, and the University of California Los Angeles (UCLA) are exc…
Destructive Tornado Hits Joplin Hospital, Lab Rebuilds Swiftly
CEO Summary: One week after one of the worst storms ever to strike a hospital in the U.S., St. John’s Regional Medical Center in Joplin, Missouri, was back treating patients. Surprisingly, the hospital’s lab was one of the first departments to get up and running again. Within…
False Positive STD Tests Get News Coverage in Indy
CEO SUMMARY: After going public with the discovery that it had reported false positive lab test results for Chlamydia to eight female patients, Mid America Clinical Laboratories (MACL) found itself the subject of stories broadcast by a local television news program. The news cove…
Using Audits to Uncover Bad Data in the Lab
CEO SUMMARY: Labs using Lean, Six Sigma, and similar quality management methods are now putting these tools to a new purpose. They are being employed to validate the accuracy of metrics designed to monitor and manage work processes directly related to turnaround times and custome…
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…
Use of Point-of-Care Testing Reduces Mortality by 50%
CEO Summary: In a thinly-populated region the size of Texas and New Mexico combined, an integrated clinical care program based on point-of- care testing (POCT) has delivered impressive gains in health outcomes. For rural residents, mortality rates from cardiovascular disease have fallen b…
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…
ER/PR Testing in Canada Continues to Make News
CEO SUMMARY: In Canada, the story about inaccurate breast cancer testing just won’t go away. In March, the Cameron Report was made public with its assessment of lab testing failures in Newfoundland and Labrador. In April, the health system in those provinces admitted that it ne…
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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