Biomedical Laboratory Science

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Showing posts with label Quality Assurance. Show all posts
Showing posts with label Quality Assurance. Show all posts

Friday, November 10, 2017

Urinalysis Quality Control at the Point-of-Care !


The goal of any clinical diagnostic test procedure is to provide critical information in a timely manner so that appropriate actions may be taken, ultimately improving patient outcomes. Point-of-care testing (POCT) is a term that has come to describe a multitude of rapid medical tests that can be performed at or near the site of patient care. The most compelling benefit of these tests is that, as opposed to having to wait hours or days for results to arrive from an outside laboratory, clinicians can obtain the results immediately, allowing for clinical management decisions to be made while the patient is still at the care facility. While the implementation of rapid diagnostic tests dates back to ancient history (sweet-tasting urine was once commonly used to diagnose diabetes mellitus), it was not until the 1950s that these rapid diagnostic methods gained any real predictive value. Today, the popularity and demand for POCT are increasing rapidly. TriMark Publications estimates that the global market for POCT was $14.5 billion in 2016, and is expected to grow by seven percent over the next five years.




Urinalysis dipsticks at the point-of-care:


Urinalysis using multi-analyte dipsticks is a point-of-care test performed at any hospital, clinical laboratory, doctor’s office, health clinic, and nursing facility. Various iterations of these tests have existed for decades, and they continue to be among the most commonly performed tests of any kind. Urinalysis dipsticks contain discrete reagent pads to semi-quantitatively test for the presence of bilirubin, blood, creatinine, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen in a urine sample.






Saturday, February 25, 2017

Evidence-based Quality Control

This article will discuss a new approach for automated hematology analyzers’ daily control limits. The discussion will cover some common issues around control of analyzers, suggest a new evidence-based approach to daily control limits, and conclude with a discussion of the benefits of this approach in the laboratory.

Some QC contexts

Too many false control rejections are the laboratory equivalent of crying wolf. Accustomed to false control rejections and not believing the problem is the analyzer, laboratorians often presume that the problem is the control and just repeat the control again. This practice often leads to multiple repetitions. It is frustrating, and difficult for operators to know when there actually is an analyzer issue.

The 1994 CAP Q-Probe study,1 completed to assess QC (Quality Control) practices and their impact on hospital laboratories, showed that 95 percent of labs repeated the same vial of control when a control run failed. In the overwhelming majority of cases, this was due to the belief that random error had occurred. (In control rules, the 13SD [Standard Deviation] means one control failure if one parameter falls outside of +/-3SD limits.) The study also found there was no benefit in using complex multi-rules or control processes for modern automated analyzers, due to the difficulty in understanding and following these complex processes. The recommendation from the study was to simplify control processes. Twenty-three years later, we have the same control issues.



Friday, August 5, 2016

External and Internal QC for Blood Gases

Quality Control (QC) and Quality Assurance (QA) in the clinical lab have changed. The Centers for Medicare and Medicaid Services (CMS) has embraced a voluntary QC option for meeting CLIA quality control standards called Individualized Quality Control Plan (IQCP), which was implemented in January 2016 for all labs that have been utilizing Equivalent Quality Control (EQC). CLIA QC regulations will remain the same as published in 2003. All of the pre-analytical, analytical, and post-analytical systems requirements in the CLIA regulations will remain in effect.

There are many different aspects of the IQCP for laboratories to consider. This article will cover the minimum requirements for use of external quality controls with regard to blood gas QC.

Minimum guidelines
The minimum guidelines according to CLIA 88 (2003) require laboratories to perform external quality control at least one time per eight-hour shift.1 The IQCP does not change this requirement. In addition to the daily QC requirement, the laboratory is also responsible for calibration verification for all non-waived “moderate to high-complexity” test systems.



Source: mlo-online

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