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Investigation of the preanalytical process practices in primary care in Istanbul regarding the newborn screening tests

  • Leyla Erdim ORCID logo , Neriman Zengin ORCID logo EMAIL logo and Büşra Karaca ORCID logo
Published/Copyright: January 18, 2023

Abstract

Objectives

The research was conducted as a descriptive study to evaluate the practices and knowledge levels of midwives and nurses in the preanalytical phase of newborn screening tests.

Methods

The sample of the study consisted of 233 midwives and nurses working in 90 primary healthcare centers in three major districts of Istanbul. The practices and knowledge levels of the participants in the preanalytical phase of blood sampling were evaluated with the Preanalytical Phase Evaluation Form [PPEF].

Results

It was determined that only 43.3% of the participants comforted the baby before taking the blood sample, and 61.8% paid attention to the temperature of the heel. Furthermore, 56.2% continued to fill the same circle on the screening card by squeezing the heel due to inadequate blood, 62.7% ensured the blood completely soaked through the front and back of the card, and 36.1% used both sides of the card to fill the circles. Only 53.6% of the participants stored the dried blood samples in the fridge. The mean PPEF knowledge score of the participants was 14.64 ± 3.40. There were statistically significant differences in the knowledge scores of midwives and nurses according to age, educational level, and working year (p<0.05).

Conclusions

In the study, it was determined that the practices of nurses and midwives in the preanalytical phase were not at a good level. In particular, it is recommended that nurses and midwives who are younger, have a lower educational level, and work fewer years be supervised and supported with training.

Introduction

The newborn dried bloodspot screening test, which is included in the primary health care services in developed and developing countries worldwide, is one of the major preventive public health services. Thanks to this test, congenital genetic, endocrinological, metabolic, and hematological diseases that can be controlled or treated are diagnosed early and quickly. Early diagnosis and initiation of treatment for these congenital diseases are extremely important as they will have a long-term effect on the baby’s health. Early diagnosis can prevent death and potential disabilities. For this reason, blood samples should be taken correctly and delivered to the laboratory, as it may affect the newborn dry blood spot screening test result [1].

The laboratory test process consists of three stages: preanalytical, analytical, and post-analytical [2]. The pre-analytical phase is the process from the beginning of the test request to the delivery of the samples to the laboratory [3]. The preventable errors attributed to human errors at this phase constitute a large part of the errors in the total testing process [4]. They may possess many risks in terms of patient safety [5]. In the preanalytical stage of the dried blood spot test obtained from newborns, many parameters affect the quality of the blood sample, such as the way the blood is drawn, the application of the blood to the filter paper, drying, transport and storage of the dried blood spot sample. Errors affecting analyte concentration caused by misapplication by professionals will result in poor-quality dried blood spot samples and false test results [68]. Major reasons for poor quality blood samples include multispotting (using multiple small blood spots to make a larger blood stain), compressing the sample after application, double layering, applying blood to both sides of the filter paper, applying insufficient sample [6], [7], [8], [9]. In terms of the reliability of screening results in newborn dried bloodspot screening programs, blood samples taken on screening cards should be of the best quality possible [6, 10]. Therefore, healthcare professionals collecting samples should have sufficient knowledge to minimize possible sources of error during the preanalytical phase of sampling [11].

Midwives and nurses working in family health centers conduct the preanalytical process of the dry blood spot test in primary health care services in Turkey. Midwives and nurses working in these centers are responsible for taking the blood sample to the filter card correctly, drying the blood sample, and delivering the sample to the central laboratory to be analyzed. In this context, it is necessary to evaluate the practices and general knowledge levels of midwives and nurses regarding dry blood spot samples in the preanalytical phase and to correct the faulty practices by means of training programs.

Materials and methods

Objectives

This descriptive study was conducted to evaluate the practices and knowledge levels of midwives and nurses regarding dried blood spot samples in the preanalytical phase.

The questions expected to be answered in the research are;

  1. What preparations do midwives and nurses make for neonatal heel prick blood sampling?

  2. How are the midwives’ and nurses’ heel prick blood sampling practices?

  3. How do midwives and nurses practice drying and transport in the heel prick blood sampling process?

  4. Do the heel prick blood sampling practices of midwives and nurses differ according to their characteristics?

Population and sampling

The study population consisted of 360 midwives and nurses working in Family Health Centers in three districts on the European side of Istanbul, Turkey. The total number of family health centers in the districts included in the study was 90, and an average of four midwives or nurses work in each center. The sample of the study consisted of 233 participants (midwives and nurses) who were on duty on the days of data collection and submitted written consent forms about their willingness to participate in the study. Of the 127 people not included in the study, only 12 did not agree to participate. The entire population could not be reached since the study coincided with the summer period and with the annual leave periods, and each family health center was visited once. The participation rate in the study was 64.7%.

Data collection tools

The research data were collected using the “information form” prepared by the researchers and the “Preanalytical Phase Evaluation Form (PPEF)” prepared for dried blood spot sampling. The information form was a tool consisting of six questions (gender, age, professional education status) that evaluated the socio-demographic characteristics of the midwives and nurses participating in the study.

PPEF was prepared in accordance with the literature [7, 12], [13], [14], [15], [16], [17], [18], [19], [20] and consisted of 21 dichotomous items (yes/no questions) to evaluate the preanalytical phase practices of dried blood spot sampling of midwives and nurses. The correct answer for seven of the 21 items was “no”, while the correct answer for 14 of them was “yes”. The items with the correct answer “yes” (items; 1, 2, 4, 5, 6, 7, 8, 9, 12, 15, 17, 18, 20, 21) included taking comfort measures for the newborn before blood sampling, wearing gloves, drying the heel, warming the heel, cleaning the heel with 70% alcohol, waiting to dry, pricking and wiping the first blood, using the side of the heel, soaking the blood evenly on the circles, filling all the circles, applying pressure on the incision site with a compress, drying cards (4 h) sending the cards to the laboratory on the same day or within 3 days and storing them in the fridge. On the other hand, the items with the correct answer “no” (items; 3, 10, 11, 13, 14, 16, 19) included keeping the heel above the heart level, squeezing the heel and applying blood drops to the same circle more than once, using both sides of the card, applying blood by using a tool (syringe or hematocrit tube) keeping the heel below the heart level after taking the blood, and keeping the dried cards unaffected by heat (Table 1).

Table 1:

Examination of preanalytical phase evaluation form statements. (Correct answer is indicated in parentheses next to the statement).

Correct (C) Incorrect (I)
Blood collection technique n (%) n (%)
Preparation of the heel for blood collection
1) Before taking blood, I support the mother by informing the mother about different methods (encouraging breastfeeding, cuddling, talking, etc.) for the comfort of the baby (preventing pain) (C). 101 (43.3) 132 (56.7)
2) Before taking the blood, I wear gloves (C). 216 (92.7) 17 (7.3)
4) I make sure the heel is completely dry before taking blood (C). 185 (79.4) 48 (20.6)
6) Before taking blood, only 70% isopropyl alcohol should be used as an antiseptic to clean the heel (C). 175 (75.1) 58 (24.9)
5) I make the heel warm (by hand warming, booties etc.) before taking blood (C). 144 (61.8) 89 (38.2)
Blood collection procedure
8) I collect the blood sample from areas on the lateral region of the heel (C). 211 (90.6) 22 (9.4)
14) If there is not enough bleeding from the heel, I take the blood into the syringe and absorb it into the circles (I). 200 (85.8) 33 (14.2)
13) If there is not enough bleeding from the heel, I take the blood into the hematocrit tube and absorb it into the circles (I). 197 (84.5) 36 (15.5)
15) I drip blood from the heel directly onto the card (C). 188 (80.7) 45 (19.3)
7) After the antiseptic on the heel has dried, the heel should be punctured and the first drained blood should be wiped with sterile gauze (C). 172 (73.8) 61 (26.2)
12) Ensure that all marked circles are completely filled with blood (C). 159 (68.2) 74 (31.8)
17) After I draw blood, I apply pressure to the area with gauze (C). 158 (67.8) 75 (32.2)
11) I use both sides of the card to fill the circles completely (I). 149 (63.9) 84 (36.1)
9) While taking the blood, I make sure that the blood is completely impregnated on the front and back of the circles (C). 146 (62.7) 87 (37.3)
16) After taking the blood, I hold the foot below the heart level for a while (I). 145 (62.2) 88 (37.8)
3) I keep the heel above the heart level in order to collect the blood from the heel comfortably (I). 108 (46.4) 125 (53.6)
10) If there is not enough blood while taking the blood, I continue to squeeze the heel for a while and fill the same circle (I). 102 (43.8) 131 (56.2)
Drying and sending the card for analysis
18) I dry the blood samples I take on the screening card at the institution on the counter for at least 4 h (C). 211 (90.6) 22 (9.4)
21) Dried screening cards must be sent to the laboratory on the same day or within 3 days at the latest (C). 163 (70.0) 70 (30.0)
19) Blood samples taken on the scanning card are not damaged by sunlight or high temperatures (I). 155 (66.5) 78 (33.5)
20) Dried screening cards must be kept in a refrigerator if they are not sent to the laboratory on the same day (C). 125 (53.6) 108 (46.4)
Total score (mean ± SD/Median (min – max) 14.64 ± 3.40/15 (6–20)

In the PPEF evaluation, each item with a correct answer was scored as 1, and each item with an incorrect answer was scored as 0. The lowest score that could be obtained from the items was zero, and the highest score was 21. The increase in the score shows that the preanalytical phase applications of dried blood spot sampling were suitable (Table 1).

Implementation of data collection tools

The researcher visited each family health center within the scope of the study. After giving information about the research topic, midwives and nurses were requested to fill in the forms in their working environment. Participants often filled in the forms in their leisure time (at lunch breaks) when they felt comfortable, and the same researcher collected the forms during working hours. The questionnaires took about 10–15 minute to complete. Each family health center was visited only once, and no repeat visits were made to meet employees who were not in the institution that day.

Statistical analysis

SPSS 22.0 [Statistical Package for the Social Sciences] software was used for data analysis. The participants’ socio-demographic characteristics and responses to each item in PPEF were assessed using frequency, percentage, total score, mean and standard deviation. Shapiro-Wilk verified the conformity of data with normal distribution. Since the data were not normally distributed, the Mann Whitney-U test was used to analyze the differences in PPEF scores according to the participant’s age and status of being a midwife or nurse, while the Kruskal Wallis chi-square test was used to examine the differences according to years of work experience and educational level. The significance level was determined as p<0.05.

Ethical aspect of the research

The research was carried out by considering scientific and universal ethical principles. The study was explained to each midwife and nurse invited to participate. They were told that they could freely participate in the study and terminate it whenever they wanted, and their written informed consent was obtained. Before the research started, approval was obtained from the clinical research ethics committee (Istanbul University-Cerrahpaşa Ethical Board Approval No: 88508) and each institution where the study was conducted.

Results

The mean age of the participants was 31.93 ± 8.31 years. The majority of the participants were nurses (51.5%). Of the participants, 39.5% of them were graduates of undergraduate studies and the years of work experience of 37.3% of the participants varied between 1 and 5 years. Most participants (84.5%) reported that they received training on the heel prick technique (Table 2).

Table 2:

Analysis of preanalytical phase evaluation form scores of participants according to their socio-demographic characteristics.

n Mean ± SD Statistical analysis
Age, years 18–30 126 13.29 ± 3.51 −6.452
(mean ± SD/median (min – max) 31.93 ± 8.31/30 (18–56) 31–56 107 16.22 ± 2.46 0.000
Years in profession 1–5 87 13.30 ± 3.73 39.254
6–10 68 14.19 ± 3.22 0.000
11–15 38 15.97 ± 2.21
≥16 40 17.03 ± 1.87
Education Medical vocational high school 85 12.88 ± 3.67 34.759
0.000
Associate degree 47 14.98 ± 2.79
Undergraduate 92 15.96 ± 2.75
Graduate 9 15.89 ± 2.93
Profession Nurse 117 13.57 ± 3.54 −4.680
Midwife 110 15.71 ± 2.96 0.000
Status of training on the heel prick technique Present 197 14.27 ± 3.50 −3.656
Absent 36 16.61 ± 1.79 0.000
  1. Mann Whitney-U test was used for comparison of two groups while Kruskal Wallis test was used for comparison of three and more groups.

What preparations do midwives and nurses make for neonatal heel prick blood sampling?

Good practices stated by the majority of the participants in the preparation phase of the blood collection technique: wearing gloves before taking blood (92.7%), ensuring that the heel is completely dry before taking blood (79.4%), 70% isopropyl alcohol should be used as an antiseptic to clean the heel before taking blood (75.1%) (Table 1). At this stage, only 61.8% of the participants reported that they warmed the heel before taking blood, and 43.3% of them informed the mother about different methods for the comfort of the baby and to support the baby (Table 1).

How are the midwives and nurses’ heel prick blood sampling practices?

The practices determined to be correct by the majority of the participants during the blood sample collection process were taking blood from the lateral region of the heel (90.6%), not using any tools for absorption (85.8–84.5%), applying blood dripping from the heel directly to the paper (80.7%) and wiping the first blood flow with sterile gauze (73.8%). The most common practices determined to be performed incorrectly by the participants during the blood collection process were squeezing the heel for a while and keeping it filling the same circle (56.2%) and keeping the heel above the heart level during blood collection (53.6%) (Table 1).

How do midwives and nurses practice drying and transport in the heel prick blood sampling process?

In the process of drying and sending dried blood spot samples, the practices determined to be performed correctly by the majority of midwives and nurses were that 90.6% of them dried their filter cards at room temperature for at least 4 hours and 70% of them sent their dried blood spot cards to the laboratory within the same day or three days at the latest (Table 1). The most common practice determined to be performed incorrectly was that 46.4% of them did not keep dried blood spot samples, which were not sent to the laboratory on the same day, in the fridge (Table 1).

Do the heel prick blood sampling practices of midwives and nurses differ according to their characteristics?

The mean total PPEF score of the participants was 14.64 ± 3.40 (min–max = 6–20; Table 1). When the difference between the PPEF mean scores of the participants according to their age groups was examined, it was seen that there was a statistically significant difference. It was found that the mean PPEF scores of those aged between 31 and 56 (16.22 ± 2.46) were higher than those in the age range of 18–30 (13.29 ± 3.51) (Table 2).

Mean PPEF scores of the participants with a working period of 16 years or more (17.03 ± 1.87) were significantly higher than the ones with a working period of 1–5 years (13.30 ± 3.73), of 6–10 years (14.19 ± 3.22) and 11–15 years (15.97 ± 2.21) (Table 2).

There was a significant difference between the mean PPEF scores of the midwives and nurses who were graduates of undergraduate studies (15.96 ± 2.75), graduate studies (15.89 ± 2.93), associate degree studies (14.98 ± 2.79) and health vocational high school studies (12.88 ± 3.67). The scores of health vocational high school graduates were significantly lower (Table 2). In the study, the PPEF scores of midwife participants (15.71 ± 2.96) were significantly higher than nurse participants (13.57 ± 3.54) (Table 2). A statistically significant difference was found between the PPEF scores of the participating midwives and nurses according to their training status on the heel prick technique. The scores of those who did not receive training (16.61 ± 1.79) were found to be significantly higher than those who received training (14.27 ± 3.50) (Table 2).

Discussion

The practices in the preanalytical phase, which affect the quality of dried blood spot samples, are crucial for an accurate and early diagnosis of congenital diseases [6, 10, 13, 21, 22] which do not show any symptoms in the first months of life; however, may potentially have serious consequences [13, 21]. Poor-quality blood samples may delay the diagnosis and thus bring along consequences that may affect the health of the baby in the long term. Successful preanalytical process management reduces blood sample rejection and enables rapid and accurate diagnosis thanks to quality samples [6, 10]. Therefore, the preanalytical errors of midwives and nurses involved in blood sampling in primary care should be determined, and their knowledge should be improved.

What preparations do midwives and nurses make for neonatal heel prick blood sampling?

One thing which is ignored by the majority of midwives and nurses regarding the preparation phase of blood sampling is pain management which is critical for mothers and babies. Piercing the heel with a lancet is a painful, invasive procedure for the newborn. Therefore, to reduce/prevent pain before blood is drawn, the mother/caregiver should be supported and informed about comfort measures such as loose swaddling, skin contact, therapeutic touch [23, 24], encouraging the mother to breastfeed or administering a dose of sucrose [19, 24, 25]. It is essential to raise the awareness of midwives and nurses regarding pain management during dry blood spot sampling.

The second practice ignored by midwives and nurses during the blood sampling process is warming the heel from which blood will be drawn. It is recommended that the newborn’s heel be warmed with a warm and moist towel (max: 42 °C) by hand or using booties before blood is drawn [7, 16, 24]. Since poor circulation in a cold heel causes inaccurate sampling [7, 16, 24]. It can be argued that this malpractice stems from the fact that the participants did not have sufficient knowledge of the topic, their workload or their disbelief in the necessity of this practice.

The research revealed that the third error midwives and nurses made during the preparation phase were not paying attention to the dryness of the area, which may affect the quality of the analyte in the blood sample, and not cleaning the skin with 70% alcohol. Especially, after the skin is cleaned, taking samples before the area dries up may disrupt the concentration of the analyte on the card, resulting in erroneous results. The guidelines recommend that the heel of the newborn should be dry to prevent infection and contamination [8, 10, 12, 24, 26], and the area from which blood will be collected should be cleaned with 70% isopropyl alcohol [24].

In accordance with this result, it can be argued that the health staff responsible for the dry blood spot sampling lacked skin preparation knowledge, hence making errors.

How are the midwives and nurses’ heel prick blood sampling practices?

It was determined that 36.1–56.2% of midwives and nurses performed practices that could lead to deterioration of analyte concentration during heel blood sampling (items 10, 11).

A significant percentage of midwives and nurses do not pay attention to the fact that the blood is spread symmetrically and evenly on both sides of the filter paper (item 9) and that the printed circles are suitably filled with blood (item 12) during the heel blood sampling process. However, since insufficient blood samples can lead to erroneous results [10], the blood sample should be soaked into all the circles (5 circles) so that it covers the entire printed circle on the filter card and an equal size blood spot is observed on both sides of the card [7, 17].

Among the blood sampling errors made by the midwives and nurses participating in the research are squeezing the heel and using the blood to fill the same circle, and soaking both sides of the card. These practices may result in the hemolysis of blood samples (item 10), double layering (items 10, 11) multi-spotted samples (items 10), and the deterioration of analyte concentration [6, 9].

In the research, it was determined that a great majority of the midwives and nurses used the sides of the heel to draw blood, they allowed the blood specimen to be absorbed by the card equally on both sides, and they filled the printed circles with the blood specimen. These results are consistent with the blood sampling practices recommended in the literature [7, 12, 14], [15], [16], [17, 26].

How do midwives and nurses practice drying and transport in the heel prick blood sampling process?

The study determined that almost all participants (90.6%) dried the cards they used for at least 4 hours and sent them to the laboratory on the same day or within three days at the latest. These results are consistent with the practices recommended in the literature [20, 26], [27], [28], [29]. However, they stated that approximately half of the midwives and nurses (46.4%) did not store the dried blood spot samples collected in their units in the fridge (item 20), instead pinned them on the panel in the unit or stored them in the box on the counter (data not shown). However, dried blood spot samples should be stored in a dry and cool place after drying [30] (Table 1).

Do the heel prick blood sampling practices of midwives and nurses differ according to their characteristics?

The mean PPEF score of the participants was found to be 14.64. Considering that a minimum score of 6 and a maximum score of 20 could be achieved on the form, it may be argued that the practices of midwives and nurses in collecting dry blood spot samples are above the medium level but insufficient. To achieve accurate results in newborn screening tests, which are vital, the blood sample must be collected correctly.

In the study, participants aged 31–56, midwives, those with longer work experience, and those who reported that they did not receive training performed significantly better practices for dry blood spot sampling. This finding could be related to experience resulting from working years and the fact that midwives are more experienced with newborns (Table 2).

Most of the midwives and nurses participating in the study (84.5%) stated that they received in-service training on the heel blood collection technique. However, it is noteworthy that the PPEF scores of those who did not receive training were higher, although the percentage of those who received training was quite high compared to those who did not. Similar results were obtained in a study, and the training provided was reported to be short-term, unsystematic, confusing, lacked theoretical information about the cause, and was only practice-based [31]. These results suggest that the content of education given to health professionals has not changed much over the years [31].

Conclusions

It was determined that midwives and nurses, who had important responsibilities in the preanalytical stage, made errors in collecting the dry blood spot sample. It was also found that the baby was not comforted in most of the blood sampling practices, and warming the heel and skin hygiene were ignored. Regarding the blood drawing process, it was determined that the blood specimen was applied to both sides of the card. In case of insufficient blood, the heel was squeezed, and the same circle was filled repeatedly. As for drying and transporting the cards, it was found that the card was not correctly stored until it was sent to the center after the blood was drawn.

Other significant results included that the higher educational level, age, and years in the profession of the participants were found to be a positive factor in obtaining a better quality dried blood spot sample. It was found that midwives had higher knowledge and made less errors in dried blood spot sampling. Moreover, it was found that the training on the heel prick technique that the participants received after graduation proved unsuccessful.

Considering the effects of dry blood stain test results, the risk of error in preliminary analyzes should be minimized and supported by midwife and nurse training programs. Before reaching the patient, their theoretical knowledge and hand skills should be improved by ensuring their participation in in-service training programs through guides and experts. Postgraduate training programs should cover all midwives and nurses who collect heel blood. The information should be updated by showing the theoretical and practical effects of correct and incorrect practices on sample quality. The negative effects of false dried blood spot results on newborns and parents should be explained [32, 33].

More research is needed to determine the errors made in practices in this field. It is recommended that single-blind studies be conducted in which midwives and nurses are observed in their working environment during heel prick dry blood spot sampling.


Corresponding author: Neriman Zengin, Prof., PhD, Department of Midwifery, Hamidiye Faculty of Health Science, University of Health Sciences Turkey, Mekteb-i Tıbbiye-i Şahane (Haydarpaşa) Külliyesi, Selimiye Mah. Tıbbiye Cad. No:38 34668 Üsküdar, İstanbul, Türkiye, Phone: +90 216 346 36 36, E-mail:

  1. Research funding: This study has no financial resources.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: The authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: Before starting to the study, approval was obtained from ethics committee of İstanbul University Cerrahpaşa (date 07/11/2018 and decision number: 88508). The study was carried out according to the ethical principles of the Declaration of Helsinki.

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Received: 2021-12-19
Accepted: 2022-11-21
Published Online: 2023-01-18

© 2022 the author(s), published by De Gruyter, Berlin/Boston

This work is licensed under the Creative Commons Attribution 4.0 International License.

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