Urinalysis Quality Control at the Point-of-Care !

Clinical Issues

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.

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Source: MedicalLaboratoryObserver

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.

Read more: Evidence-based Quality Control

Source: MedicalLaboratoryObserver

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.

Read more: External and Internal QC for Blood Gases

Source: mlo-online

Proper QC of Hematology Critical Values

The reporting of critical values—laboratory results that indicate a possible life-threatening situation for a patient—requires rapid clinical intervention in order to avert significant patient morbidity and mortality. Given the imperative of clear, accurate, and expeditious communication of critical value results from the laboratory to clinicians, one method of ensuring prompt handling is to create a protocol that optimizes workflow by eliminating waste and placing checks and balances throughout the process.

As with most vital aspects of laboratory work, managing hematology critical values depends largely on the acumen and aptitude of staff. Thus, an instituted protocol will only be successful if staff technologists are properly trained, gain sufficient knowledge of all involved systems and automation, and are equipped with tools to recognize the effectiveness of checks and balances.

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Source: medlabmag

Pre-Analytical Errors in Biomedical Chemistry Laboratory

Detecting and minimizing pre-analytical variables in clinical analysis

Pre-analytical variables refers to any and all procedures that occur during sample collection, prior to sample analysis. This involves patient identification, physical sample collection, sample transportation to the testing site and sample preparation. 

Pre-analytical errors account for 32%-75% of laboratory errors1. These errors can have a significant impact on laboratory results and it is imperative that laboratory personnel are able to spot these erroneous results, rather than falsely attributing them to an underlying medical cause.

External pre-analytical variables

Some factors such as exercise, eating, drinking and medication can affect patient results. Eating and drinking affects glucose, triglycerides, alkaline phosphatase, alanine, aminotransferase, inorganic phosphate, cholesterol, folic acid, urea, potassium and more. It is recommended that a fasting sample be taken if these sensitive parameters are to be measured.

Exercise should not be undertaken immediately before blood tests such as CK, AST and LDH. In some cases, medication may be postponed for several days until a blood test can be taken, unless the blood test is for therapeutic drug monitoring purposes.

Read more: Pre-Analytical Errors in Biomedical ChemistryLaboratory

Pre-analytical variables account for 32%- 75% of laboratory errors

Source: selectscience