Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
We knew that the accreditation agencies needed to develop their own policies to handle the new CMS IQCP regulations. CAP gets the prize for being first out of the gate with some practical steps, as well retaining some safeguards for quality.
IQCP, if it's not already burned into your head, stands for Individualized Quality Control Plan, and this is supposed to be the replacement for the EQC policies which have been in place for several years. The EQC policies are being replaced, you may recall, because they are scientifically untenable. It was hoped that IQCP was going to be more scientifically robust. That remains to be seen. CAP is attempting to assure that it will implement the CMS IQCP regulations but also provide a higher level of quality assurance than that low bar.
More after the jump.
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Posted by Sten Westgard, MS
Some recent articles on the subject of Quality Indicators have reminded me that analytical quality is to laboratory management much like the laboratory is to the hospital: over-worked, under-appreciated, and assumed to be of reliably excellent quality.
- Laboratory Medicine Quality Indicators: A Review of the Literature, Shahram Shahangian, PhD, MS, and Susan R. Snyder, PhD, MBA, Am J Clin Pathol 2009;131:418-431
- A Summary of Deliberations on Strategic Planning for Continuous Quality Improvement in Laboratory Medicine, Dana Marie Grzybicki, MD, PhD, Shahram Shahangian, PhD, Anne M. Pollock and Stephen S. Raab, MD. Am J Clin Pathol 2009;131:315-320.
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Posted by Sten Westgard, MS
A recent news investigation produced a litany of laboratory errors. Can you guess which of these lab errors actually happened?
- a blood screening test fails to identify a critical blood disorder in a pregnant woman. Her child dies 3 weeks after being born
- an HIV test falsely identifies a husband as HIV positive. The couple separates, the wife unwilling to trust the husband anymore.
- a paternity test sample gets switched: a father is falsely told that his daughter is not his biological child. The family splits up. Nearly 4 years later, the laboratory contacts him and tells him he was the father. The father-daughter bond remains broken.
The answer, after the jump.
Posted by Sten Westgard, MS
This week two Harvard doctors wrote an op-ed for the Wall Street Journal: Why 'Quality' care is dangerous (subscription may be required, depending on time of access). In this essay, they warn of the dangers of what they term the "quality metrics" that provide the basis for "pay-for-performance" systems that may govern physician reimbursement. Under any of the proposed healthcare reforms, P4P schemes may be used as a way to "incentivize" doctors and clinicians to provide the right care to their patients.
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Posted by Sten Westgard, MS
In a recent article in Annals of Clinical Biochemistry, a group over in the UK did an unusual thing - they audited their IQC (internal quality control) practices. The North Thames Audit and Quality Assurance Group use a questionnaire to assess the IQC practices in 54 laboratories in part of the United Kingdom. Here's the specific citation:
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Posted by Sten Westgard, MS
Diagnostic errors are one of the "new" hot topics in the healthcare field. A new study from British Medical Journal of Quality and Safety has a chilling estimate of just how common diagnostic errors are occurring in outpatient settings.
So what's your guess? How often in the US are diagnostic errors being made in outpatient settings?
- about 1 in 5 visits
- about 1 in 10 visits
- about 1 in 20 visits
- about 1 in 50 visits
- about 1 in 100 visits
The study's conclusion, after the jump...
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Posted by Sten Westgard, MS
As many of you know, the FDA has issued new draft guidelines about Blood Glucose Monitoring Test Systems for Industry and Manufacturers.
Recently, the AACC held an excellent webinar where an Dr. Courtney Lias, PhD from the FDA discussed the intentions of the new guidances and then fielded a LOT of questions. I don't want to step on what Dr. Lias and the AACC accomplished during their webinar. There was useful information in that presentation and I encourage others to consider getting those materials once they become available on the AACC website.
However, while reading through the guidances and talking to laboratories these past few months, I thought I might share a few observations...
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