Venous blood sampling (phlebotomy) is the most common invasive procedure performed in health care. It consists of several discrete steps, all of which can be subject to errors [1, 2] which potentially impact patient safety. Amongst the errors are patient/sample misidentification so that analytical results are not associated with the correct patient ; alteration of the concentration of some analytes by prolonged use of a tourniquet [4, 5] or by contamination of the sample with intravenous fluids  and contrast media ; inadequate patient preparation, i.e., fasting [8–10] or increased physical activity ; not achieving the specified blood collection volume, which may lead to the incorrect additive to blood ratio and thus affect the test results  and many others. In addition to factors that can affect sample quality, some practices can also have an impact on patient or healthcare worker safety . For example, if the collection site is not correctly disinfected, or is touched post disinfection, then the site will not be sterile. Also, if the healthcare worker does not wear gloves or dispose the collection device correctly, there is the potential for the worker to come into contact with blood-borne pathogens.
Whilst guidelines on correct practice are available, including the H3-A6 guideline issued by the Clinical Laboratory Standards Institute (CLSI) in 2007 , recommendations issued by national societies , or the guidelines on drawing blood published by the World Health Organization in 2010 , the complexity and large number of blood collections, in conjunction with their locations, make assessments of adherence to guidelines challenging. There are many reasons for which blood collections do not conform to published guidelines, including the lack of understanding the impact of using incorrect procedures, not being familiar with the relevant guidelines, an unwillingness to follow the guidelines, workload or insufficient time . External factors such as a lack of support from others in the hospital environment can also have an impact . Changes in laboratory methods can lead to a need to adapt phlebotomy procedures, and training can help to improve practices [19, 20]. Currently, there is a wide range of different professions with varying level of experience and education who are involved in blood sample collection procedures at the European level. Due to such heterogeneity, there is obviously a need for continuous education and training of healthcare personnel involved in phlebotomy procedures . It has been demonstrated that education leads to improved adherence to guideline recommendations for patient identification, tourniquet release and test tube labelling .
Unfortunately, the quality of practices and procedures related to blood sample collection in European countries is currently not known. Therefore, the aim of our study was: 1) to assess the level of compliance of phlebotomy procedures with CLSI H3-A6 guideline; and 2) to identify the most critical steps which need immediate attention and improvement in EFLM member countries by creating a risk occurrence chart based on the observed error frequency and severity scoring.
Materials and methods
This survey was conducted by the EFLM Working Group on the Preanalytical Phase in the period of June 2013–March 2014. Important key issues were chosen from the CLSI guideline by all members of the working group and addressed in such a manner that an observational study was possible with simple yes/no answers for the majority of the questions. As shown in Figure 1 the study checklist consisted of 29 specific questions for the observer, addressing different issues of the venous blood sampling process from the preparation phase (Did the collector assemble all necessary supplies prior to collection?) through the sampling process (Did the collector clean the venipuncture site?) to the post sampling phase (Did the collector check potential complications of venipuncture?).
The investigation was conducted as an observational study. Staff members performing blood collection (i.e., collector) were observed three times in three different settings: 1) an outpatient phlebotomy unit; 2) a hospital clinical ward; and 3) an emergency department. Since, due to the practical or legal issues, it was not possible to perform collections in all settings, the final number of collections per location differed among participating countries.
Possible replies were: 1) yes; 2) no; and 3) not applicable (NA). The favourable answer (compliance) for most of the study checklist questions was yes. If the reply was no, it was considered as evidence for non-compliance with the procedure.
Q6 was analysed only in phlebotomies performed in outpatients.
Q13 and 14 were analysed only in those who responded positively to question 12 (Did the collector clean the venipuncture site?).
For Q19 (Were any of the sample tubes clearly under- or overfilled?), no was considered as the favourable answer. Therefore, for this question yes was considered as non-compliance and presented in the study results as deviation from the correct procedure (i.e., error).
For Q25 (When were the sample tubes labelled?), the favourable answer was if samples were labelled after phlebotomy.
Q26 was analysed only for those who have labelled the tubes after phlebotomy.
Results are presented as counts and percentages. Differences between groups were analysed with χ2-test. Data were analysed in MedCalc statistical software 126.96.36.199 (Frank Schoonjans, Mariakerke, Belgium). A p-value <0.05 was considered as statistically significant.
Risk occurrence analysis was done using the semi-quantitative methodology developed for medical device manufacturers in the internationally agreed standard ISO 14971 Annex D . This analysis defines processes and tools to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. In our study, rather than hazards associated with a medical device, we have used the risk occurrence analysis to assess potential hazards associated with the phlebotomy procedure. Severity was assessed individually by all members of the working group (n=11) and the median score was used for further analysis. Probability was equal to the frequency of the error observed during the survey. Possible occurrence and severity scores were as follows (Tables 1 and 2).
Severity and probability were used to construct the risk occurrence chart (Table 4). Phlebotomy steps located in the ‘green’ region are considered as generally acceptable and for those steps no further risk reduction is required. ‘Yellow’ region is the region of ALARP (as low as reasonably practicable), where probable risk should be as low as reasonably practicable. Steps in that region are pointing to the need for an action to lower the probability of risk. ‘Red’ zone is the intolerable region. Steps located in the red zone are those for which the estimated risk is unacceptable. For those steps, immediate action is required to lower the probability of an error.
Twelve European countries participated in this study: Croatia, Czech Republic, Denmark, Italy, Kazakhstan, The Netherlands, Norway, Russia, Serbia, Sweden, Turkey and the UK.
The median number of audits per country was 33 (18–36). The total number of audits was 336. Their distribution across three categories of patient healthcare setting [emergency department (EMG), outpatient department (OUT) and clinical wards (WARD)] is presented in Figure 2.
Phlebotomies observed during the study were performed by five different healthcare personnel categories: medical doctors (DR), nurses (NURSE), laboratory staff (LAB), phlebotomists (PHLB) and administrative staff (ADMIN). The majority of phlebotomies were done by nurses and laboratory personnel. The distribution of phlebotomies performed by different professions is presented in Figure 3.
Administrative staff was involved in phlebotomies only in the outpatient setting, whereas all other professions were equally distributed across patient settings (emergency department, outpatient department and clinical wards).
Summary results for all 29 questions are presented in Figure 4.
Frequency of errors occurring during the phlebotomy and their respective severity scores are presented in Table 3. Q2, 3, 7, 17 and 25 relate to the policy of the institution and show collective behaviour and systematic deviations from the correct procedure, rather than individual non-compliance. For Q10, we have observed only one non-compliant sampling occasion probably reflecting difficulty of the auditor to assess whether the phlebotomy site was suitable, rather than the actual compliance. For this reason, this question was excluded from further analysis and interpretation. Median error rate for the total phlebotomy procedure (complete checklist, without Q10) was 26.9 (10.6–43.8), pointing to the low overall compliance with recommended CLSI procedure.
The risk occurrence chart (Table 4) provides an overview of the priority that was estimated by WG members for each phlebotomy step. In our survey, the steps in the ‘red zone’ which had the highest combination of impact and probability were Q3, Q4, Q25 and Q26. Those steps were assessed as being of critical importance and a top priority for laboratory professionals. A critical error within the phlebotomy procedure was the identification procedure (Q4).
For Q4 (Identification procedure), the level of compliance of a collector with a recommended identification procedure differed significantly between different patient settings (p=0.011). The overall frequency of identification errors was rather low, but identification errors were still assessed as causing the major patient safety risk, due to potential high degree of severity of harm to the patient. Identification errors were more frequent in emergency and outpatient departments, as compared with clinical wards (Figure 5).
The level of compliance (for Q4) with recommended identification procedure also differed significantly between different type of professions (p<0.001). Administrative staff was most likely to be non-compliant with the recommended identification procedure (Figure 6).
Q25 and 26 were also in the ‘red zone’ due to their substantially high degree of potential harm to the patient and frequency. Whereas Q25 probably reflects the importance of institutional policy, Q26 provides information about whether the tubes were labelled in the presence of the patient (this question was applicable only for those phlebotomies during which tubes were labelled after the phlebotomy). The frequency of errors related to Q26 differed relative to the different patient settings and were more prevalent on clinical wards than in emergency departments and outpatient settings (p<0.001) (Figure 7). Furthermore, the error frequency was highest in medical doctors and nurses than in other types of professions involved in phlebotomy (p<0.001) (Figure 8).
The level of compliance of phlebotomy procedure with the CLSI H3-A6 guideline in 12 European countries was found to be unacceptably low and patient identification and tube labelling were found to be the most critical steps.
Preanalytical phase has been recognised as the significant source of errors and variability in laboratory testing since the early 1970s of the last century and the terms ‘influence’ and ‘interference factors’ became a part of standard terminology in laboratory sciences ever since . In fact the preanalytical phase is now acknowledged as the main contributor to diagnostic errors in the total testing process . Venous blood specimen haemolysis or clotting, incompletely filled test tubes, patient misidentification and mislabelling of test tubes are some of the most frequent errors in the preanalytical phase. Most of the errors are detected and corrected for, but a substantial proportion of unsuitable specimens and test requests unfortunately goes undetected and may in the end affect the clinical management of the patients. Potential consequences of preanalytical errors for the patient are: the need for test repetition and repeated blood sampling causing the patient discomfort and risk of delayed diagnosis or therapy, additional diagnostic procedures, increased healthcare costs, inappropriate diagnosis or therapy as well as hospitalisation and even death.
Laboratories and laboratory personnel have traditionally been putting most of their efforts into the improvement of the analytical phase with focus on sample processing and reducing analytical bias and variation. Since phlebotomy is most often done outside the laboratory and not under the direct supervision of the laboratory staff, errors which occur during phlebotomy are not easy to address and correct. In addition, analytical laboratories often monitor, register and address the seemingly randomly distributed preanalytical errors that arise throughout the healthcare organisation. These errors are often not effectively managed and still pose a challenge to laboratory professionals and constantly jeopardise patient safety .
Clinical practice guidelines aim to guide healthcare staff in decision making and are an indispensable part of professional quality systems . Adherence to guidelines aims to standardise medical care; raises care quality and reduce patient risks by reducing inappropriate variations in practice [27, 28]. Clinical practice guidelines are usually consensus statements on best available practice in a particular area, and are increasingly embraced by international healthcare organisations, such as the World Health Organization (WHO) .
Guidelines on venous blood specimen collection practice, such as the commonly used CLSI H3-A6 guideline (CLSI 2007) or the guideline published by the WHO, are comprehensive and extensive and describe many discrete chronological practice steps, all of which can be subject to error. The drawback of the standards is that numerous practice steps are quite often difficult to remember for the phlebotomist. Thus, the most important steps may be forgotten or unintentionally missed. The standards are limited to the collection procedure and therefore to a large extent focused on patient and collectors safety and not on the overall effects of a bad sample collection or sample handling on the patient safety. The guidelines in addition do not contain risk evaluation of the different steps and also lack advice on how to best implement and sustain practices recommended by the guideline. As such, these standards are less suited for daily healthcare practice or for risk management to minimise the risk for compromised patient safety.
In our study, the observed phlebotomy error frequency and a severity scoring yielded a risk occurrence chart where the key issues in the critical ‘red region’ which had the highest combination of impact and probability were Q3 (expiry dates of collection devices), Q4 (patient identification), Q25 and Q26 (specimen labelling). The identification and labelling steps are important safety barriers and are intended to prevent patient identity mix-up as the last defense. Q3 was left aside as expiry dates of devices by the collecting staff were seldom performed directly by the phlebotomist as demanded by the guidelines, but performed by other staff in the logistic chain and therefore judged as an overall moderate risk. A critical error within the phlebotomy procedure was the identification procedure (Q4) because of the high severity scoring combined with a remote frequency of observed errors. Identification errors were more frequent in emergency and outpatient departments, as compared with clinical wards. Misidentification errors are not easily detectable in daily work . However, they have been reported with unacceptable frequency in everyday routine work by several authors [30–32]. Identification errors along with the proper diet restriction assessment and failure to allow patients to rest prior to phlebotomy were the most frequent errors observed in one recent cross-sectional comparative study performed in three government hospitals in South Ethiopia from February 2012 to September 2012 . Improving patient identification by reducing the frequency of errors is therefore an ongoing challenge in all types of blood collection procedures and also a critical issue in other healthcare areas .
The specimen labelling questions (Q25 and 26) were also in the ‘red zone’ due to their substantially high degree of potential harm to the patient and frequency. Labelling the specimen after blood sampling and not in the presence of the patient was a moderately frequent error in our study but was assessed as being possibly life threatening. This issue is therefore of critical importance, highly relevant and obviously shows room for improvement.
Individual  as well as organisational external factors  impact guideline non-conformity. Our data indicate corrective action flaws at both the organisational and individual levels. Recent studies on clinical practice guideline adherence have mainly focused on the organisational aspect. Studies to identify reasons for individual hazard behaviour that might explain habitual choices to ignore important safety rules are few and empirical research on the relationship between workplace affiliation and healthcare staff adherence to venous blood specimen collection practice guidelines is currently lacking. It is remarkable that administrative staff were non-adherent to patient identification and doctors to tube labelling procedures. This could reflect serious flaws in their phlebotomy education and should be addressed with great attention. The association of various occupations with adherence to guideline practices was shown to differ significantly in a study of hand hygiene . However, in a study of guideline adherence in cardiopulmonary resuscitation, no such association was found . Further research is warranted on both organisational and individual factors contributing to higher levels of clinical practice guideline adherence and increased patient safety. Patient safety programmes that minimise risk of harm to patients and providers through system effectiveness as well as individual practice are needed [37, 38].
Guideline adherence may be improved by education and training  but accreditation of venous blood specimen collection only has marginal effects . The ISO 15189:2012 standard  regulates that the laboratory is responsible for producing adequate instructions and possibility for training and that it is responsible for the conditions of the samples at arrival too. This means that the preanalytical conditions are regularly reviewed by the laboratory and the national accreditation bodies in turn regularly assess the laboratory’s adherence to good practice . National societies of clinical chemistry and laboratory medicine carry a substantial responsibility to ensure, preserve and improve patient safety. With existing contradictory or insufficient guidelines and regulations, errors may occur in the lower levels of the organisation [42–44]. Modifying guidelines to become more focused, easy to understand and applicable should be prioritised in future research and health care .
Modifying staff behavior to conform more closely to practice guidelines and other recommended practices has proved to be a difficult task . One reason is that efficient and accurate methods of measuring adherence are missing as they are essential for policies and programmes aiming to improve adherence. Questionnaires are the most widely used instrument to assess clinical guideline adherence [46–48] and questionnaires have successfully been used also to monitor venous blood specimen collection guideline adherence . Observational studies are seldom used, but have the advantage of direct observation of specimen collection errors and when performed in a larger scale, such as this study, also allow an error frequency determination for each key issue. In this observational study we added a severity grading to the observed error frequency to get an overall risk assessment and indication on the most critical practice steps when to implement corrections.
Adoption of clinical practice guidelines is affected by several issues, among them the way they are implemented . High evidence that the context is accessible to change, appropriate monitoring and feedback mechanisms , and available time for personnel to discuss research findings [51, 52] are mentioned as important factors for improving adherence to guidelines.
Observation of venous blood specimen collection practices using a template checklist and risk analysis is an efficient method to assess critical steps in phlebotomy. Moreover, feedback, discussions and reflection amongst phlebotomy personnel promises to be an efficient tool to implement and sustain adherence to phlebotomy guideline practice [53–55] and lead to long-term improvements in patient safety.
Our study shows that the overall level of compliance of phlebotomy procedures with CLSI H3-A6 guideline in 12 European countries is unacceptably low, especially regarding patient identification and tube labelling. These issues call for immediate attention and improvement.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Financial support: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organisation(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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About the article
Published Online: 2014-12-23
Published in Print: 2015-08-01