Members’ Musings

Members’ Musings

The views of the members of the EFLM Working Group for Preanalytical Phase

Stephen Church

Stephen Church (SC) is associate director medical affairs at BD Diagnostics – Preanalytical Systems, Oxford, UK.

Michael Cornes

Michael Cornes (MC) is principal clinical biochemist at The Royal Wolverhampton NHS Trust in Wolverhampton, UK.

Pinar Eker

Pinar Eker (PE) is a biochemistry and clinical chemistry specialist at Umraniye Research and Training Hospital, Istanbul, Turkey.

Kjell Grankvist

Kjell Grankvist (KG) is a professor and senior consultant of the Department of Medical Biosciences, Clinical Chemistry, Umeå University, Sweden.

Mercè Ibarz

Mercè Ibarz (MI) is head of the Clinical Biochemistry Unit and the laboratory quality assurance manager at the University Hospital Arnau de Vilanova, ICS Leida, Spain.

Gunn Berit Berge Kristensen

Gunn Berit Berge Kristensen (GBBK) is head of the Norwegian EQA organization for medical laboratories in Norway.

Edmée van Dongen-Lases

Edmée van Dongen-Lases (EvDL) is a clinical chemist and staff member at the Department of Clinical Chemistry of the Academic Medical Center in Amsterdam, The Netherlands.

Giuseppe Lippi

Giuseppe Lippi (GL) is director of the clinical chemistry and haematology laboratory of the University Hospital of Parma, Italy.

Luděk Šprongl

Luděk Šprongl (LS) is head of the Central Laboratory and manager for Complement, Nemocnice Šumperk, Czech Republic.

Why is the preanalytical phase the biggest source of lab errors?

Giuseppe Lippi: There are several reasons, including the fact that: (a) it’s often overlooked as a cause of errors (all lab errors are still too often associated with analytical errors); (b) it’s poorly standardized (too many national and international guidelines exist about best practice in this phase); (c) there is poor training of doctors and nurses on how to collect a quality specimen; (d) no internal or external quality control systems have been established so far.

Edmée van Dongen-Lases: It relies on humans, and therefore it’s prone to human error.

Kjell Grankvist: Most laboratories still focus solely on analytical quality. Laboratories need to take more responsibility to try to minimize errors regardless of which phase of the total testing process they occur.

Michael Cornes: There are multiple reasons: i) it’s often outside the direct control of the laboratory; ii) it’s poorly standardized both nationally and internationally and guidelines are often inadequately followed; iii) there is a lack of understanding of the consequences of errors as there is a disconnect between where the error occurs and where its impact is seen; iv) staff are under a lot of pressure because of decreasing staff numbers, decreasing funding and increasing workload, which leads to increasing human errors; v) there is insufficient funding for technological solutions leaving healthcare years behind other industries (i.e. private sector). The technology is there but we are unable to use it.

Stephen Church: I agree, the source of these errors are often outside of the direct control of laboratories, and the staff who collect samples are not aware of the impact that, what seem small errors in their practices, have on sample quality and identification and therefore a lab’s ability to provide accurate results. I call it the domino effect: if something goes wrong at the beginning, the further the erroneous sample advances through the analytical process, the greater the impact on laboratory efficiency, laboratory cost and ultimately patient care.

Pinar Eker: Preanalytical actions are outside the walls of the lab; it is always easier to manage what we can see. For many years, laboratory professionals have been too busy in their labs dealing with analytical procedures – we liked playing with numbers, which is always easier than managing people. The preanalytical phase is the part of our work that is mainly governed by “human factors”; as long as the challenge of managing “human factors” exists, so too will our preanalytical challenges. Besides, clinicians generally do not know much about the preanalytical phase and the impact it has on the total test process. They think the analytical phase is the most error prone stage, and this is a really big issue. All health professionals must know more about what the preanalytical risks are and their effects on test results. We must change the way of thinking; this phase is not only the responsibility of lab professional and this means we will need much more training. Patients also need to be trained.

What are common mistakes laboratories make in protocol design that may lead to an increased likelihood of preanalytical error?

Gunn Berit Berge Kristensen: Guidelines and protocols are often too comprehensive and too long. They should focus on important issues and be as short as possible. They stand a better chance of being used if they are simple, logical and perceived as useful.

Luděk Šprongl: Intelligible and clear instructions often don’t exist for those who prepare the patient for phlebotomy, and this causes problems. Common errors are also made in the transportation of phlebotomy samples, so it’s important that labs are made aware of the optimum time and transport conditions.

PE: As laboratorians we must be trained in processes before we design our protocols. I believe we need some basic social sciences training, like management skills. Protocols must be prepared by a team that has specialists from different disciplines Making protocols is not enough. We have some protocols for every phase in our quality management systems, but we must follow the indicators and analyze the results and replan according to the outcomes of this process.

What are common sources of preanalytical error relating to laboratory setup, equipment setup or use?

EvDL: Designs, layouts and placements of laboratories, which make sample flow more difficult may lead to an increased likelihood of preanalytical phase error.

GBBK: When you get new equipment in the laboratory it is often randomly placed where there is space. One should think LEAN (manufacturing) – a way of thinking and acting for an entire organization. LEAN represents a culture of continuous improvement that depends on the alignment between purpose, process and people. This way of thinking and acting should be used when organizing a laboratory in general, in blood sampling and how external/internal samples are sent to the central laboratory.

LS: The most common mistakes are during the centrifugation. There are different conditions (temperature, time, speed) for different analytes. However, some technicians don’t follow the rules because they want to simplify the process or reduce time. I also believe that lack of optimum storage conditions can sometimes pose a problem – time, temperature, repeated thawing.

Mercè Ibarz: Common errors in equipment setup, in my view, mainly include: incorrect sample centrifugation, belief in the value of serum indices without validating the method and lack of consideration of possible interferences. With regards to the physical space, preanalytical phase errors are more likely if: there is a delay in sample transport, the preanalytical area is located far away from the laboratory entrance or with a difficult access, and the preanalytical area is too small.

PE: The distance between the central sampling point and the laboratory is important. Laboratory specialists must be able to control every sampling step easily, whenever they want.The system mustn’t allow patients access to their sample tubes; they should be managed only by the phlebotomist. Sampling rooms need more IT supporting solutions. Every phlebotomist must have a special code/barcode reader and recorder, and patients must have codes/barcodes with them. All three barcodes – that of the patient, tube and phlebotomist – must be combined at the point of sampling. Another issue is hemolysis and laboratory analyzers must have a serum indices program with the ability to measure the HIL parameters quantitatively.

From your own experience, what are the most common sources of preanalytical error?

GL: Hemolyzed specimens due to poor collection practice or catheter blood drawing.

KG: Without doubt, hemolysis of the venous blood specimen.

MI: Blood samples, specifically: the sample not being received, hemolyzed samples, clotted samples and insufficient samples. Urine samples not received is also a common error.

MC: In our lab the most commonly seen errors are tests not being initially requested, hemolysis of samples, booking in errors, and samples not being received.

SC: The collection of blood samples from catheterized patients is a common source of error based on my experience, and this is because nursing staff do not want to subject the patient to a further needle stick. However, there are no recognized standardized processes in order ensure that a sample of the highest quality is collected. Common errors include hemolysis and contaminated samples. These can be avoided by implementing good practices, such as not drawing the blood sample immediately after catheter insertion, and never collecting from an infusing line.

What are the easiest preanalytical phase errors to avoid and how?

GBBK: I think implementing electronic requisitioning of laboratory samples will reduce patient identification and tube labeling errors. Continuous training and education is also very important.

LS: The majority of preanalytical errors are avoidable in my opinion. The best way is to provide clear instruction, regular education, and also to regularly control all parts of the preanalytical phase.

MC: The easiest errors to avoid are as follows: sample contamination by following the correct order of draw; sample identification errors by education and automation – using machines that automatically provide the correct tubes and label them is a great help; booking in errors by increasing education, increasing staff numbers and/or automation; hemolysis can be decreased by using dedicated trained phlebotomists.

Overall the key steps to improve the preanalytical phase are standardization, education and automation, all of which require continuous funding. Education alone is not enough unless it is continually monitored. You cannot improve what you do not measure!

What is your top piece of advice for laboratories looking to reduce preanalytical phase error?

GL: Strengthen the education of doctors, nurses and technicians about preanalytical quality, and establish a comprehensive system of quality in the preanalytical phase that entails systematic monitoring of non-conformance.

EvDL: Automation. In my experience, automating functions has led to the biggest reduction in preanalytical phase errors.

KG: Repeated local observational studies with error frequency assessment and risk analysis of preanalytical practice errors, combined with direct feedback, discussions and reflection amongst involved personnel, seems to be the most efficient strategy for sustained good preanalytical practices.

MI: I would say the following are needed: continuous training, well-defined processes that are written and accessible in the workplace, clear definition of responsibilities and fluid communication with phlebotomists.

SC: The best piece of advice I can offer is to leave the laboratory and go and observe the processes outside of your laboratory that influence the sample quality. Look at how the patients are identified, how the samples are collected, understand the challenges that the phlebotomist has in collecting a sample from various patients, and how the samples are transported to the laboratory. Conduct systematic reviews of these processes in order to understand the challenges, create partnerships and help educate those that are collecting samples that the laboratory is so reliant on.

"Brain to Brain Cycle" of Lab Testing