Review Article

Ann Lab Med 2012; 32(1): 5-16

Published online January 1, 2012

Copyright © Korean Society for Laboratory Medicine.

Managing the Pre- and Post-analytical Phases of the Total Testing Process

Robert Hawkins, M.D.

Department of Laboratory Medicine, Tan Tock Seng Hospital, Tan Tok Seng, Singapore

Correspondence to: Robert Hawkins
Department of Laboratory Medicine, Tan Tock Seng Hospital, 11 Jalan Tan Tock Seng 308433, Singapore
Tel: +65-6357-8943
Fax: +65-6235-6507

Received: September 20, 2011; Revised: September 20, 2011; Accepted: November 4, 2011

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.


For many years, the clinical laboratory’s focus on analytical quality has resulted in an error rate of 4-5 sigma, which surpasses most other areas in healthcare. However, greater appreciation
of the prevalence of errors in the pre- and post-analytical phases and their potential
for patient harm has led to increasing requirements for laboratories to take greater responsibility for activities outside their immediate control. Accreditation bodies such as the Joint Commission International (JCI) and the College of American Pathologists (CAP) now require clear and effective procedures for patient/sample identification and communication
of critical results. There are a variety of free on-line resources available to aid in managing the extra-analytical phase and the recent publication of quality indicators and proposed performance levels by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group on laboratory errors and patient safety provides particularly useful benchmarking data. Managing the extra-laboratory phase of the total testing cycle is the next challenge for laboratory medicine. By building on its existing quality
management expertise, quantitative scientific background and familiarity with information
technology, the clinical laboratory is well suited to play a greater role in reducing errors and improving patient safety outside the confines of the laboratory.

Keywords: Specimen handling, Laboratories, Quality assurance, Healthcare, Diagnostic errors, Risk management