TAG:
quality system
New Business Helps Reduce Pathology Specimen ID Errors
CEO SUMMARY: Prevention of diagnostic testing errors is getting more attention by both physicians and pathology labs because patients are less tolerant of potentially life-changing errors. Strand Diagnostics’ Know Error system is designed to reduce or eliminate errors involving tissue s…
Lab Specimen Transport Eliminates Need for Ice
CEO SUMMARY: Because of its unique design and reliability, a new product for transporting laboratory specimens and units of blood without the use of ice and dry ice is gaining favor with innovative laboratories across the country. Kaiser Permanente of the Mid-Atlantic States uses this ice…
Ohio Lab Offers Lessons Learned from CAP 15189
CEO SUMMARY: For a lab looking to continually improve lab operations, becoming accredited to either ISO 15189 or CAP 15189 is an ideal challenge. After hearing from other lab directors about the benefits of becoming accredited to CAP 15189, the staff at Mercy Medical Center in Canton, Ohi…
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. …
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…
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…
Two U.S. Labs Pursuing ISO 15189 Accreditation
CEO SUMMARY: In their first public interviews, the nation’s only two laboratories to seek ISO 15189:2007 accreditation share insights about the process, along with its challenges and benefits. Both laboratories are in the final stages of implementation and expect to earn accreditation b…
ISO 15189 Is the Goal at Avera McKennan Lab
CEO SUMMARY: Now entering its ninth month on the path to accreditation under ISO 15189:2007 Medical Laboratories, Avera McKennan’s lab recently completed its “gap analysis.” This important step prepared the laboratory for the pre-assessment and assessment steps that will result in a…
First U.S. Labs Nearing ISO:15189 Accreditation
CEO SUMMARY: Laboratories, hospitals, and other health-care providers in the United States will increasingly be required to adopt quality management systems (QMS) as part of their regular operational routine. This is consistent with trends in other developed countries. Several U.S. labora…
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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