Posted by Sten Westgard, MS In the December 2011 issue of Point of Care journal, an interesting study was published: Preanalytical Errors in Point-of-Care Testing: Auditing Error of Patient Identification in the Use of Blood Gas Analyzers, Natalie A Smith, David G Housley, Danielle B. Freedman, Point of Care, Volume 10: Number 4, December 2011. The study looked at patient identification errors on a blood gas analyzer in various departments in a hospital. Bearing in mind that this is just one type of pre-analytical error, what do you think the rate was? Given around 100,000 tests, what would you guess as the number of defects? -----

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS [Hat-tip to the AACC Point-of-Care listserve, which first posted a notice about this article] The Pennsylvania Patient Safety Advisory has a regular electronic newsletter highlighting new science and studies about healthcare safety. Their December 2011 issue has a particularly interesting article for laboratory testing: Point-of-Care Technology: Glucose Meter's Role in Patient Care, Lea Anne Gardner, PhD, RN, Senior Patient Safety Analyst, Pennsylvania Patient Safety Authority. This review examined more than 1,300 reports of glucose-meter problems from the Pennsyvlania reporting system database from 2004 to 2011. Of those reports, 71 near-miss or adverse event reports occurred. Most intriguing are the report excerpts directly quoted in the study. Of those reports, 72% of the near-miss or adverse events occurred with high-blood glucose results. That is, where the glucose meter had a sudden high value that may or may not have been reflective of the actual patient's clinical state. For example: "A patient's blood sugar was checked using a [glucose meter]. The lunchtime result was 517. A [blood glucose test] was [immediately] retaken to check for accuracy, and the result was greater than 600. A blood [laboratory] test was conducted per protocol, and the [lab] glucose [result] was 136..." What do you think happened next? -----

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS Now that we know EQC will officially be phased out and instead Labs will have to develop QC Plans through Risk Analysis (as explained in CLSI's new guideline EP23A), some of the waiting is over. EQC, which was fatally flawed from the start, is going to go away. However, the exact regulations about QC Plans and Risk Analysis have yet to be written (or, at least, are not yet known by the general public). What makes this more uncertain is that EP23A is only meant as a guideline, and the Risk Analysis approach discussed in the guideline is only meant as a possible example. Risk Analysis is a long-established technique (outside the medical laboratory) and has many different formats and levels of complexity. Even between EP18 and EP23, there are discrepancies between the Risk Analysis recommendations (EP18 recommends a 4-category ranking of risk, while EP23 recommends a 5-category approach). So while we're waiting for the other shoe to drop (in the form of detailed regulations and accreditation guidelines governing Risk Analysis), we might as well talk about what questions those rules will have to answer... -----

Posted by Sten Westgard, MS<

Posted by Sten Westgard, MS

Posted by Sten Westgard, MS Here's an eye-opening report from the Office of Inspector General from the Department of Health and Human Services: Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries So what's your best guess on the frequency of adverse events? -----

Posted by Sten Westgard, MS A recent Clinical Laboratory Strategies article:Anchoring POC Quality in Clinical Decision-Making and the related study: Novel analysis of clinically relevant diagnostic errors in point-of-care devices, KM Shermock, MB Streiff, BL Pinto, P Kraus, an dPJ Pronovost,  (J Thromb Haemost 2011;9:1769-1775) have an interesting observation about the use of the correlation coefficient to accept method performance. They looked at Hemochron POC devices, analyzing 1518 paired INRs. The correlation between the POC and laboratory measurements ranged between 0.84 and 0.91. The authors stated, "Traditional, quarterly, quality assurance studies emphasize correlation analysis." So this study has good news, right? -----