Background
Venous blood specimen collection (VBSC) is one of the most common procedures in healthcare [
1]. It is a basis for diagnosis and treatments [
2,
3]. VBSC is, in accordance with other healthcare practical skills, a complex procedure that demands theoretical knowledge and manual skills, as well as accuracy, ability, good caring conduct and good interaction between the phlebotomist and patient [
4]. Errors in VBSC may lead to patient suffering and jeopardize patient safety [
2]. Injuries related to VBSC errors are caused most often by human mistakes and relatively few are related to technical errors [
5]. In addition, VBSC errors are latent and distant from direct control and thus often go unrecognized. Therefore, VBSC practices should strictly follow guidelines based on evidence and best practices [
6‐
9].
The majority of errors within the total testing process occur in the pre-analytical phase, meaning before the sample is analysed in a laboratory [
1‐
3,
10‐
13]. Analytical errors (within the laboratory) and post-analytical errors (reporting and interpretation of results) are less frequent [
2,
13]. Some examples of the pre-analytical errors encountered are incorrect analysis ordered [
14], incorrect patient identification procedures, incorrect patient preparation procedures such as insufficient patient rest, using information from outdated sources [
15,
16], and wrong type of collection tube [
2,
10]. A common reason for specimen rejection and renewed sampling is specimen haemolysis, which most often is due to incorrect specimen collection including prolonged venous stasis and not sufficiently filled tubes [
1,
10,
17‐
19]. Common specimen handling errors include incorrect test tube labelling [
2,
15,
20,
21], incorrect test request management, missing tubes, and transport errors [
2,
8,
10,
14,
22].
In Sweden, healthcare personnel are obliged by law to secure patient safety, keep up-to-date with healthcare guidelines, and act according to evidence-based practices [
23]. Still, healthcare personnel do not always follow guidelines [
14‐
16,
21,
24], and in particular are not updated with the results of new research and changed guidelines [
25]. Some reasons for the low compliance to guidelines have been found to be due to personnel disagreeing with recommended guidelines and considering them unnecessary [
26]. Lack of time as well as lack of support from the clinic or their superiors are other reasons [
27]. Difficulties in implementation of healthcare guidelines and evidence-based care into daily practices can lead to patients not receiving the best possible care as well as being exposed to risks or adverse events [
25].
Previously we used a validated self-reported questionnaire [
28] and found that phlebotomists’ self-reported practical performance was poor, showing non-adherence to VBSC guidelines [
14‐
16,
21,
24,
29]. This motivated a large-scale educational intervention program (EIP) intending to update VBSC and implement national [
7] and local [
6] VBSC guidelines of VBSC personnel (2171) within the Västerbotten County Council (VLL). A large-scale EIP can be carried out by the whole healthcare organisation to improve quality of care. Few studies have evaluated the impact of large-scale EIPs on guideline adherence and healthcare practices [
30]. The aim was to evaluate the impact of a large-scale EIP on primary health care phlebotomists’ adherence to VBSC guidelines. Our hypothesis was that the EIP would improve phlebotomists’ VBSC practical performance.
Discussion
We evaluated the impact of a short but large-scale EIP on phlebotomists’ practical performance and adherence to VBSC guidelines. Our main finding was that the study demonstrated several significant improvements on IG phlebotomists’ adherence to VBSC practices. Compared to the CG we found few significant improvements. Still, guideline adherence improvement to several crucial phlebotomy practices is needed.
Staying updated with the latest laboratory sampling procedures is important since laboratory methods change, and VBSC instructions change with them [
10,
11]. In rural areas (as in northern Sweden), it is particularly important that healthcare personnel are aware of how to search and have access to correct information on the internal network [
25]. Hence, the VBSC personnel’s ability to gain updated on-line manuals instead of outdated printed guidelines is crucial in order to maintain high levels of guideline adherence [
34], probably leading to improved practical performance, more reliable test results and better patient outcomes [
10,
11]. In nurses’ basic education and training, the Swedish National VBSC guideline [
7] which is based on for example an international guideline [
8] with updated information is usually used. However, after basic education, VBSC education for phlebotomists had been absent or rudimentary until this EIP was performed.
Patient identification procedures demand accuracy as well as responsibility. High accuracy and exactness in practical skills ensure patient safety [
35]. On the contrary, failure in accuracy during patient identification procedures may lead to specimen collection from the wrong patient, giving dramatic consequences with respect to diagnosis and treatment [
2]. Results after the EIP show that 83% of PHCs phlebotomists often or always asked for name and identification number or checked the photo-ID compared to 70% in 2007 (
p = 0.042) (results not shown). Still, these figures are not acceptable. One suggestion is to revise the EIP to a modular structure and have one module focusing solely on patient identification procedures, with possibilities for reflections and discussions. A study succeeded in improving blood volume in the bottles after three educational sessions indicating that a modular structure may improve performance. Long-term effects were not measured [
36]. In terms of the total implementation process, it is well known that improvement of routines and practices are an on-going process. A single general EIP seldom influences all participants to improve [
27].
Since the body position causes changes in plasma volume that influence the test results, patients have to rest in a sitting position before specimen collections. As test results are compared with previous results or reference intervals, samples must be taken following the same procedures [
20,
37]. Although personnel work more in line with guidelines it is still only 37% (Table
4) who allows the patient to rest before sampling indicating that more education is needed to sensitize the importance of rest.
In this study the IG phlebotomists reported shorter venous stasis which probably leads to more reliable test results even if we can’t prove that in this study. Prolonged venous stasis has been shown to influence test results and, for example, increase the potassium concentration [
38,
39]. Venous stasis is often necessary during specimen collection to localize the vein, but should be released as soon as possible or within one minute to avoid discomfort as well as affecting test results [
7,
8,
38,
39]. Lima-Oliveira
et al. performed a phlebotomy training program [
40] and eliminated a number of deviations by increasing adherence to CLSI H03-A6 guideline [
8]. Thereby, a proposal was to clean the venepuncture site and let dry before stasis, in line with the Swedish national guideline [
7]. If the participants cleaned the venepuncture site before stasis were not investigated in present study.
Trans illumination (cold near-infrared light-emitting diode) is also a valuable tool to localize veins especially in patients with difficult or small veins, such as children’s. A comparison between use of tourniquet and trans illumination showed no differences if using tourniquet as recommended by guidelines [
38].
In contrast to Lima-Oliveira and his co-workers [
40], we found no improvement in test tube inversion practices. In the Lima-Oliveira study, 17% inversed test tube correctly before training while in our study the corresponding proportion was 67% reporting that they always reversed the tube 5–10 times according to guidelines [
7]. Another explanation may be that the training in our study was short (2-hours) and general. Test tube inversion after sampling is important for mixing the collected blood with additives in the test tube [
8]. Test tubes are at higher risk of haemolysis if reversed more than 12 times [
1,
11]. Research and evidence on the importance of reversing specimens is disputed [
41,
42], and this may influence the phlebotomists’ adoption of guidelines [
34]. A recently published study shows that vigorous mixing of test tubes does not promote laboratory variability [
41]. Unclear recommendations and contradictive instructions may negatively influence the phlebotomists’ attitudes for change. There is still lack of universal consensus due to conflicting reports [
43]. Motivation to change is dependent on strong evidence. If personnel believe that following guidelines would result in improved patient outcomes and improved working conditions, they probably would be more likely to change behaviours [
44].
Errors related to ID or barcode linkage can cause delay or incorrect ordering of analysis, thereby delivering inaccurate test results to the patient [
2,
20,
22]. Still, despite the intervention, 16% of the IG PHC phlebotomists reported that they sometimes labelled the test tube at a later occasion or allowed somebody else to label afterward, which is unacceptable. Internationally, frequently occurring VBSC problems, is mislabelling of test tubes; figures as high as 1 in every 165 specimens have been described [
20]. In 2009, the National Board of Health and Welfare in Sweden reported 40 adverse events within blood transfusion medicine and 20 of these adverse events were due to incorrect handling or incorrect labelling of test tubes [
45]. However, the VBSC guidelines are unclear on this topic. International guidelines as in The Clinical and Laboratory Standards Institute standards [
8] recommend labelling test tubes whilst alongside the patient after specimen collection, and the national handbook for healthcare recommends to label the test tube before leaving the side of the patient [
7] but the local directive [
6] recommends labelling test tubes prior to specimen collection in accordance with the Swedish National Board of Health and Welfare [
46]. Thus, it is important to standardise and clarify guidelines so they cannot be interpreted as contradictory [
43]. One suggestion from a recently published editorial note is to implement bar coded specimen labels and draw blood only in the event of correct match. This would be a quite new procedure in health care and solve the problem whether blood tubes should be labelled before or after VBSC [
47].
Methodological considerations
Large-scale intervention programs are difficult to evaluate as they include a number of activities and are difficult to standardize to suit whole organizations such as all the PHCs in a specific county council [
30]. Programs often have short- and long-term outcomes that have to be studied from different perspectives [
30]. Even though it is difficult, we succeeded in evaluating a large-scale EIP with a validated questionnaire [
28]. We also monitored low-level haemolysis in a follow-up study. Haemolysis reflects a blood specimen’s quality and is caused most often by improper specimen collection [
48]. The present study has a comparative before and after design with a CG from another county council which may produce better evidence that differences are due to the programme and not to something else [
30]. Thus, by using the county council as a control, we reduced the risk for spill over effect. The dropout rate was 23%, a figure that probably did not influence the overall results. Accreditation of healthcare and clinical laboratories has been increasingly utilized as a tool to try to enhance healthcare quality [
49]; we used a similar approach to our completed EIP, providing all VBSC personnel who passed the exam with a competence certificate hopefully increasing the personnel’s motivation.
Both counties within this study are affected daily by different parameters that are difficult to have control over and may affect the study. Multiple components such as the lack of awareness, agreement with, or limited familiarity with guidelines [
27], lack of support from the clinic or superiors, and time constraints or understaffing appear to be the main impediments for successful implementation of guidelines [
27,
34]. Since our EIP was mandatory, probably some were not motivated to change procedures, this could have influenced our results negatively. A weakness with the short EIP is that it contained no practical training or possibilities for deeper discussions.
The lack of more significant differences when comparing the IG to the CG may be influenced by previous questionnaire survey 2007, recall bias, the sample size, as well as a small variation among the answers (for example item 12c, 81% of the IG phlebotomists stated that they always stored the test tube in a test tube stand, the high percentage providing a small space of change). We also noted positive changes regarding items 7a and 7b (patient identification), the results implying that the VBSC personnel reflected about the procedures, already knowing that guideline adherence was low.
There was an imbalance between the CG and the IG regarding VBSC personnel professional status; more enrolled nurses were employed in the CG whereas more registered nurses were employed in the IG. However, we found no significant differences in self-reported answers regarding adherence to guidelines between those two professional groups. The frequency of VBSC showed no significant differences (p = 0.028) in our study.
One third of the IG performed EIP through live internet link while the others had traditional lectures; however, there were no significant differences in seven randomly selected items found between the groups. The study population was clinically relevant, as the distribution of the phlebotomists’ professional status is typical of Swedish PHC VBSC personnel.
The clinical implication
The EIP in this study was general for pre-analytical practices. Our results indicate that regular screening of VBSC errors and an EIP could help phlebotomists to keep up to date. Yet, a revised EIP directed and compressed with increased focus on specific topics including reflections and discussions is probably more effective at improving and sustaining adherence to VBSC guidelines and practices. A “Model of Practical Skill Performance” [
35] for systematic planning, useful for reflections and with focus on the specific elements in a skill together with VBSC guidelines, could probably improve and sustain guideline adherence and VBSC practices [
35].
A review from 2003 graded interventions; it found that mass media campaigns, small group interactive meetings, reminders, computerized decision support, and introduction of computers to aid in practice were the most effective methods [
25]. Most intervention studies have some effect, but no intervention method is good enough to obtain effective changes in all kinds of settings. It is important to study the total implementation process in order to develop interventions that are more effective in the future [
25]. To develop effective EIPs, we need knowledge about pedagogical possibilities and barriers to the implementation process. E-learning is a cheap and growing educational tool, proper for large organizations and accessible to personnel in rural areas. It is also flexible and allows VBSC personnel to perform the EIP at work [
50].
Implementation and translation of VBSC guidelines can be managed through a research team fostering intervention and practice assimilation by providing personal influence, motivation, retraining and instrumental assistance [
51,
52].
There are few evaluations of how guidelines should be effectively implemented, and it is often unclear who is responsible for implementing and sustaining guideline knowledge and practices [
34]. The structure and content of the guidelines also affect their adoption; if they are easy to understand and can be tried out easily, there is a greater chance of successful implementation [
27]. We suggest that VBSC guidelines should be easy and go point by point in describing their approach. Local guidelines should adapt to national and international guidelines but also secure that guidelines is in accordance with the Swedish National Board of Health and Welfare regarding VBSC.
Acknowledgements
This work would not have been possible without the laboratory instructors who performed the EIP: Susanne Hermansson, Ann-Britt Lindström, Marie Backlund and Marie Lundgren. We would like to thank the Faculty of Medicine, Umeå University, Umeå, Sweden, the Swedish National Board of Health and Welfare, Sweden, LVN and VLL, Sweden for research funding.
Funding for work
We would like to thank the Faculty of Medicine, Umeå University, Umeå, Sweden, the Swedish National Board of Health and Welfare, Sweden and VLL in Sweden for research funding.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
KB, JS, CB and KG proposed the original idea for the study. KB and JS collected the data and executed the statistical analyses together with ML. All the authors then discussed and participated actively in the interpretation of data continuously during the process. KB drafted the manuscript and all authors then read the draft critically, all contributed with important intellectual views to the content and approved the final draft.