Have you noticed how much more attention waived testing is getting these days? We know that CLIA has defined waived tests as laboratory procedures which employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; and which pose no reasonable risk of harm to the patient if the…
DetailsAs a Laboratory Quality Advisor I offer advice and guidance to laboratories that are preparing for their upcoming laboratory inspection. The goal is to not only reduce the number of citations that labs receive, but most importantly offer advice on how to improve their processes and ultimately provide better patient care. It is not uncommon…
DetailsProficiency Testing is an important part of any laboratory quality assessment program. It is an external assessment of your staff’s performance by facilitating the comparison of your laboratory’s test results with other laboratories using the same instruments or kits, and methodology. While we have discussed proficiency testing before , in the context of competency assessment,…
DetailsI recently assisted a laboratory that had some questions about quality assurance (QA) while in the process of preparing for their first laboratory inspection. As a continuous quality advisor, I spend a lot of time educating labs about QA so let’s focus on QA for this week’s topic. For new labs devising a quality assurance…
DetailsCMS personnel requirements, which include not only qualifying education, training and experience, but on-going competency assessments as well, are limited to the defined technical positions within the laboratory. As a result, we tend to think of front office personnel, including those who may also perform phlebotomy, or order lab supplies, as “other than” laboratory people;…
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