High preanalytical non-compliance and samples rejection rate in clinical biochemistry laboratory are decreased by nurse staff training in phlebotomy and sample handling

Background: Preanalytical phase of biomedical analysis remains an important source of diagnostic errors that deserves special attention. This study aims to evaluate the training in phlebotomy and sample handling impact on the preanalytical non-compliances. Material and Methods: we performed a prospective study before and after staff training in phlebotomy and sample handling by systematically recording all clinical samples non-compliances. First, we assessed and describe the noncompliance baseline rate from January to December 2017 in the clinical biochemistry laboratory of Hôpital Sominé DOLO de Mopti. After two sessions of one week staff training in January 2018, we performed the same study from January to December 2018. We compared the proportions of non-compliances between the two assessments. Data were collected on the case report forms, captured in Excel and analyzed by R software for (Mac) OS X version 4.0.3. Pearson Ch2 or Fisher exact tests were used for the comparison of proportions. The statistical significance was set at p < 5%. Results: a total of 27,810 venous blood samples were received during the study period; 48% was for biochemistry, 41% for immuno-serology, 9% for blood cell count and 2% for coagulation tests. There were 3,826 instances of preanalytical non-compliances (13.76%) identified that led to sample rejection. Out of the 11 types of non-compliances investigated, 5 (45.4%) accounted for nearly 91% of the problems: insufficient sample volume (28.9%), hemolyzed samples (20.5%), inappropriate collection time (17.8%), sample clot (12.9%), and inappropriate sample collection tube (10.8%). We observed a significant difference in rates of non-compliance between inpatients and outpatients samples (44.4% vs 7.3%; p < 0.001). The proportion of non-compliance have significatively decreased after the two training sessions of hospital staff in phlebotomy and sample handling 3,826/27,810 (13.8%) vs 3,009/32,476 (9.3%); p < 0.001. Conclusion: we report a significantly higher rate of non-compliance in inpatients. Hospital staff training in phlebotomy and sample handling reduce the proportion of preanalytical non-compliance and thereby improve patient management and safety.


Background
Advances in biomedical technologies, particular automation and the development of bidirectional laboratory information systems have made outstanding improvements in the quality of the analytical and postanalytical phases of testing [1]. However, the preanalytical phase of biomedical analysis remains an important source of diagnostic errors that deserves special attention [2][3]. Preanalytical sample non-compliances taints the quality and validity of biomedical analysis results. Moreover, preanalytical errors could be harmful to patient outcome when they are not detected. Noncompliance in the preanalytical phase is responsible for 60 to 70% of laboratory errors. In addition, about one-fifth of preanalytical errors could lead to inappropriate clinical decisions, treatments, untimely re-testing, and economic losses [4]. The International Organization for Standardization (ISO) 15189 version 2012, in its chapter on the technical requirements for the accreditation of medical biology laboratories, attaches particular importance to the preanalytical phase [5]. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Laboratory Errors and Patient Safety project working group recommends the identification and systematic recording of preanalytical quality indicators for the improvement of test quality and patient safety [6]. The purpose of this work was to assess the impact of staff training in phlebotomy on preanalytical non-compliance in order to focus interventions to improve patient care and safety.

Material and Methods
We performed a prospective study by systematically recording all clinical samples non-compliance from January to December 2017 to assess causes of samples non-compliances and their proportions in the preanalytical phase in our clinical biochemistry laboratory. Inpatient specimens were collected by clinical department nurse staff, while outpatient blood samples were collected on site by laboratory staff, or referred from other health facilities in the city. After two sessions of one week staff training in January 2018, we performed the same study by systematically recording the preanalytical non-compliances from January to December 2018. The study was first validated by the scientific committee and submitted for approval to the ethics committee of the Hôpital Sominé DOLO de Mopti. Patient's rights were respected, particular their anonymity was preserved so that no data could be linked to a patient. This study involved venous blood samples for biochemistry, blood cell count, immuno-serology and coagulation. Specimen non-compliance with requirements was checked by our quality assurance manager according to a checklist designed for this purpose. Issues recorded include inappropriate sampling time, hemolysis, inappropriate tube, insufficient volume, sample clot (for blood count or coagulation testing), inappropriate transport delay, inappropriate transport temperature, sample damaged or lost during transport, inappropriate ratio of anticoagulant/sample (for coagulation testing), wrong test requested, and unlabeled sample. Data was recorded in the case report forms, captured in Microsoft Excel and analyzed by using R software for Mac OS X version 4.0.3. Pearson ch2 or Fisher exact tests were used for the comparison of proportions with p-value ≤ 0.05 as the threshold of statistical significance.

Results
A total of 27,810 venous blood samples were received in laboratory, of which 48% was for biochemistry, 41% for immuno-serology, 9% for blood cell count and 2% for coagulation ( Figure 1). There were 18,390 (66.1%) samples from outpatients and 5,371 (19.3%) inpatient samples. A total of 3,826 preanalytical non-compliances (13.8% of samples received) led to sample rejection. Out of the 11 non-compliances studied, 5 (45.4%) accounted for near 91.0% of the preanalytical problems ( Figure 2). These were: insufficient sample volume (28.9%), hemolyzed samples (20.5%), inappropriate sampling time (17.8%), sample clot (12.9%) (in coagulation and hematology samples), and inappropriate tube type for testing requested (10.8%). We observed a significant difference in non-compliance rates between inpatients and outpatients (44.4% vs. 7.3%; p < 0.001). Non-compliance with sampling times, insufficient sample volume, hemolyzed samples, sample clot in the EDTA and citrate tubes and collection in an inappropriate tube were significantly more frequent with inpatients samples (Table 1). In contrast, non-compliance with delivery times and temperature during transport was significantly more frequent in outpatients. We found no difference between inpatient and outpatient samples for damaged or lost specimens, anticoagulant /sample ratio errors, incorrect analyte recording, and unidentified samples. The proportion of non-compliance have significatively decreased after the two training sessions 3,826/27,810 (13.8%) vs 3,009/32476 (9.3%); p < 0.001. However, training did not have a reducing effect on sample damaged or lost during transport, inappropriate transport delay, and inappropriate transport temperature. In contrast, the other non-compliances have significatively decreased after the two training sessions (Table 3).

Discussion
Limitations of this study include lack of evaluation of test request form, patient's preparedness for tests, and microbiology specimens, which also constitute important preanalytical quality indicators as described by ISO 15189:2012 [5] and Laura Sciacovelli and al [6]. Also we did not assess the baseline of nurse knowledge's in phlebotomy and samples handling before and after training sessions. Nevertheless, systematic recording of samples noncompliances yielded interesting results in clinical biochemistry laboratory. The proportion of the outpatients sample in our study is comparable to that obtained by Ambachew S and al in 2018 who reported 70.1% and 29.8% respectively for outpatients and inpatients sample [7]. The rate of samples non-compliance in our study (13.8%) was very high compared to those observed by Ma Jesús Alsina and al in 2008 [8] (0.699%), Guimaraes AC and al in 2012 [9] (0.57%), Aykal G and al in 2016 [10] (2.35%) and Lourens A Jacobsz and al in 2011 [11] (1.46%). However, other high rates of non-compliance similar to those obtained in our series have been reported by Zeliha Gunnur Dikmen and al in 2015 [12] (13.3%) for coagulation tests. Our high rate of non-compliance suggests a very strong need of strengthen the training of our staff on phlebotomy and samples handling. The most common causes of sample rejection in our study also differed from those in other studies. Ma Jesús Alsina and al in 2008 [8], found that 3 non-compliances (unreceived samples, hemolyzed sample and blood clot) had caused 81.0% of preanalytical non-compliances [8]. Insufficient volume, hemolyzed sample, blood clot and inappropriate tube have been reported as the leading causes of samples noncompliances in several studies [13,11,9,12,8]. This suggests that acting on these major non-compliances would significantly reduce the rate of samples rejection while improving result turn-around time (TAT). Furthermore, this should improve effectiveness and efficiency in the management of bedridden patients, since 5.1% of repeated sampling resulted in critical results [11]. We observed a significant difference in non-compliance rates between inpatients and outpatients (44.4% vs 7.3%; p < 0.001). This pattern was found also by Maria Salinas and al in 2015 [14]. However, Ana-Maria Simundic and al in 2010 [15] observed the inverse pattern (1.12% vs 1.36%; p = 0.0006). It's well known that non-compliances are more likely to be occurred in pediatric department because of challenges associated with sample collection, specimen volume, hemolysis and blood clot [16]. In our study, we observed significant difference between pediatric samples non-compliances compared to adult samples non-compliances (20,7% vs 10,0%; p < 0.001). The high rate of non-compliance among inpatients in our study could be linked to a low level of knowledge of nurse staff on phlebotomy and samples handling mainly in pediatric department as reported by Cai Q and al in 2018 [17]. In contrast, non-compliance with delivery times and temperature during transport was significantly more frequent in outpatients samples. This could be explained by the outsourcing of samples from other health facilities in Mopti region and the fact that those samples were collected by laboratory technologists which are well trained in phlebotomy and sample handling. To reach continuous improvement of the preanalytical process quality, we performed two sessions of training of our staff. After these training we gained a significant reduction on preanalytical non-compliance rate (13.8% vs 9.3%; p < 0.001). Güzin Aykal and al in 2016 achieved a significant increase in the level of knowledge of the phlebotomist from 58.9% to 91.8% and have decreased sample non-compliance from 2.35 % to 1.56% after training their staff in preanalytical process. [10]. Fatma Demet Arslan and al in 2018, also achieved an increase in learners correct responses and a significant decrease in preanalytical errors (0.6% vs 0.5%; p < 0.05) [18]. Our study shows high rate of samples rejection, their typology and where they commonly occurred. Systematic control and recording of non-compliances represent not only a monitoring tool that could be used to sharpen interventions like training of staff in phlebotomy and samples handling but also a post-training evaluation tool to measure the impact of the intervention.

Conclusion
The total rejection rate was 13.8%. Out of the 11 preanalytical non-compliances, 5 account for near 91% of preanalytical errors mainly from inpatients. The training of the nurse staff in phlebotomy and samples handling significantly decreased non-compliance rate 13.8% vs 9.3%; p < 0.001. Systematic recording of samples non-compliances and continue training of nurse staff could be used to monitor and assess preanalytical non-compliances for patients safety.

Acknowledgments
We thank Dr. Robert Dufour emeritus professor of pathology at George Washington University in Washington, DC for his inputs and advices. We are grateful to all study subjects for participating in this study; the staff of Mopti hospital, French Agency for Development (AFD) for funding and logistical assistance through Expertise France.

Disclosure of conflict of interest
Authors certify that there is no actual or potential conflict of interest in relation to this article. Funding for training comes from French Agency for Development through Expertise France and is free from all sources of conflict of interest.

Statement of informed consent
Each participant gave fully informed written consent prior to enrollment. The protocol was reviewed and approved by Hospital committee.