Governmental perspectives on evaluating laboratory performance

Abstract

The quality of laboratory analytical performance required to support medical decision-making has been defined in four major ways: (a) by the analytical variance of the state of the practice; (b) by the total variance, including analytical and biological variability; (c) by the loss of diagnostic efficiency attributable to analytical error; and (d) by medical-usefulness criteria. From the federal government's perspective, the answer to the question "How good must a laboratory test result be to be medically relevant?" must take into account the clinical context of the test, with accompanying concerns about access, timeliness, and cost, as well as limits for precision and accuracy in the analytical process and the frequency and potential patient-care impact of error in the pre- and postanalytical steps of the total testing process. Therefore, medically relevant goals should encompass not only analytical precision and accuracy but also goals to provide access to clinically effective tests and to reduce errors in the total testing process that can lead to medically misleading information. Development of more appropriate regulatory requirements for laboratories, as well as any needed improvements in instrumentation and methodology, should focus on ensuring that goals for medically relevant results are met by appropriate design and management of the entire process of laboratory testing.

Prevalence and types of preanalytical error in hematology laboratory of a tertiary care hospital in South India

“…There is a drastic improvement in the performance of laboratories due to remarkable advances in automation, sample collection, transport, and dispatch of reports. [ 1 ] Medical laboratories also play a vital role in the decision-making of physicians about their patients. About 60%–70% of clinical decisions regarding admission, prescription, and discharge are based on laboratory results.…”

Preanalytical issues identification and prevention in clinical hematology laboratory: best practice for patient safety

“…Several other studies confirm that test requests can be a clinically important source of errors [14]. Paper based test requests are risky as they can be incompletely filled, placed in the wrong collection box, or simply be lost.…”

Study on "Pre-analytical Errors in a Clinical Biochemistry Laboratory:" The Hidden Flaws in Total Testing

“…Laboratory errors might occur at any of these three phases, depending upon their source and time of presentation respectively. The pre-and post-analytical phases of the process account for 93% of the errors [3].…”