Abstract
INTRODUCTION:
With the advent of different technologies, multiple manufacturers are producing blood bag systems with different salient features. It is important for transfusion services to select a blood bag system with the best features and quality. This requires an objective evaluation with emphasis on the donor and user experience. Based on a validated questionnaire, this study aimed to design a system for the objective evaluation of two or more blood bag systems from different manufacturers.
SUBJECTS AND METHODS:
A case–control observational study was conducted over a period of 1 month at a tertiary care center involving regular repeat voluntary whole blood donors, phlebotomists, and technical staff. A questionnaire was designed based on focused study group discussions and was validated. The new blood bag system comprised the case arm (n = 30), while the routinely used blood bag system comprised the control arm (n = 30). Responses were recorded for both arms and analyzed.
RESULTS:
Needle prick was reported as painful by 83% of study donor population (P < 0.005). Eighty-nine percent of the phlebotomists reported that needle penetration force was more for the novel blood bag system (P < 0.005).
CONCLUSIONS:
The novel blood bag system had certain limitations about the phlebotomy and needle characteristics which may affect the donor and phlebotomist’s experience. The blood components did not deviate in quality parameters as per the guidelines of national standard bodies. A similar evaluation of any newly procured reagent and supply item should be done before introduction to the blood transfusion services.
Keywords: Novel blood bag system, phlebotomy, validated questionnaire
Introduction
Blood bag systems form an essential part of blood transfusion services, playing a significant role in the collection, separation, storage, and transport of blood components. With the advent of newer technologies over a period of decades, blood bags have evolved and undergone several modifications to accommodate patient needs. Different manufacturers from across the world are introducing new blood bag systems for consumers to choose from, adhering to the ISO 3826:2006 guidelines. The entire vein-to-vein transfusion process starts from the collection of blood from a donor in the blood bag. Hence, the quality of blood bags is important for all the persons involved in this process such as blood donors, phlebotomists, and technical staff.[1] Phlebotomy-related needle trauma may result in platelet activation and can result in RBC damage, which may affect the quality of blood components.[2] Moreover, a pleasant donor experience is essential in retaining the voluntary donor pool. While selecting a specific blood bag system, a proper objective evaluation is required with importance to the various requirements of a blood center and that may require a comprehensive scientific evaluation. A standard questionnaire may be helpful in highlighting the different experiences involved at different levels. This study was planned to design a comprehensive system for the objective evaluation of two or more blood bag systems from different manufacturers by evaluating responses from the regular voluntary whole blood donors, phlebotomists, and technical staff at our blood center.
Subjects and Methods
This study was an observational study conducted over a period of 1 month at a tertiary care center in North India. The study recorded responses from experienced individuals/professionals at three levels who were involved in the blood donation process, blood bag processing, and routine quality monitoring and reporting procedures – regular voluntary whole blood donors, phlebotomists, and technical staff. For this study, we selected repeat voluntary donors who donated whole blood at least three times in the previous year at our blood center, nursing officers who have performed at least 10,000 whole blood donation-related phlebotomies in the last 3 years, and technical staff involved in blood bag processing for at least 3 years.
Designing a questionnaire
For designing the questionnaire, we developed a study design based on multiple focus group discussions for an in-depth exploration of different viewpoints from three different vantage experiences, vis regular voluntary donors, phlebotomists (nursing officers) and technical staff. A total of 100 regular repeat voluntary donors were selected. All nursing officers and technical staff were included. The above-mentioned individual groups were asked to mention the aspects of phlebotomy that ensure a smooth phlebotomy experience and the different properties of blood bags that allow smooth handling and processing. The different responses were noted, as described in Table 1. To eliminate bias, the participants were not informed of the specifics of the study. Rather, they were requested to indicate their experiences in order of importance. We chose focus groups to understand what a particular topic meant to different sets of individuals. The focus group sessions facilitated discussion, consensus building, idea development, and debate on a specific topic of interest, which helped in generating new responses. In addition, the dynamics of group interaction helped resurface forgotten details that might not have been assessed in individual response filling. Based on the inputs, a questionnaire outline was designed. These responses were then used to design a questionnaire [Table 2]. The questionnaire was evaluated and validated before being introduced in this study.[3]
Table 1.
Description of the responses from different individuals who are involved in whole blood donation collection and processing, on what defines a user-friendly blood bag system
| Responses from regular repeat whole blood donor |
| Less pain associated with needle prick |
| Less force with which needle penetrated the skin |
| Wearing gloves and maintaining universal precautions |
| Proper preparation of phlebotomy site |
| Proper explanation of the procedure by the phlebotomist before the donation procedure |
| Viewing the needle prick during phlebotomy |
| Previous experiences of pain associated with phlebotomy |
| Senior experienced phlebotomists |
| Responses from experienced phlebotomists |
| Less needle penetration force |
| Facial expression of donors (facial grimace) |
| Ease of pasting identification labels |
| Ease of opening a needle protector |
| Less force if needed to break the valve |
| Ease of sample collection from diversion pouch |
| Tubing that is less kink resistant and is of appropriate length |
| Ease of overwrap opening |
| Responses from blood centre technicians |
| Less amount of time taken for extraction |
| Less incidence of sealing error, suitable for sterile dock |
| Any deviation during component separation |
| Any deviation during storage of components |
| Any deviation in quality indicators of blood components |
| Any patient-related adverse reaction reported |
Table 2.
Questionnaire for evaluation of novel blood bag systems
| Serial number | Different responses recorded in the three sections of the questionnaire | Response indicators |
|---|---|---|
| 1 | Regular repeat whole blood donor | |
| 1.a | Needle penetration force | Minimum/Moderate/Severe |
| 1.b | Pain associated with needle prick | Mild/Moderate/Severe |
| 2 | Experienced phlebotomists | |
| 2.a | Needle penetration force | Minimum/Moderate/Severe |
| 2.b | Facial expression of donors (Facial grimace) | Present/Absent |
| 2.c | Label printing | Easy/Neutral/Difficult |
| 2.d | Needle protector (Rigid) | Easy/Neutral/Difficult |
| 2.e | Force needed to break the valve | Mild/Moderate/Severe |
| 2.f | Sample collection from diversion pouch | Easy/Neutral/Difficult |
| 2.g | Kink resistance of the tubing | Low/Neutral/High |
| 3 | Responses from Blood Centre technicians | |
| 3.a | Total time taken for extraction | (in minutes) |
| 3.b | Any deviation during component separation | Present/Absent |
| 3.c | Any deviation during the storage of components | Present/Absent |
| 3.d | Any deviation in quality indicators of blood components | Present/Absent |
| 3.e | Any patient-related adverse reaction reported | Present/Absent |
Study design
This study was done with the new blood bag system (novel blood bag system) that comprised the case arm and the routinely used blood bag system (standard blood bag system) that comprised the control arm. Each arm included 30 responses. Repeat voluntary whole blood donors, nursing officers, and technical staff involved in blood bag processing in our center were included. Their responses were recorded, based on the questionnaire for both arms and analysed. Mean was used for data values with symmetric distribution, otherwise, median was used. Statistical analysis was carried out using t-test analyses (both paired and unpaired) for numerical variables and Chi Square Test of Independence for categorical variables with Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, version 23.0 for Windows).
Results
The study included 30 whole blood collections using the novel blood bag system and 30 whole blood collections using the standard blood bag system. Packed red blood cells, fresh frozen plasma, and platelet concentrates were prepared from all of the above collections. The certificates of analysis adhering to ISO 3826:2006 were comparable for both the blood bag systems. Blood bag sterility assessment didn’t detect any significant microbial growth in both. The responses from the donors, phlebotomists, and technicians involved were summarized [Table 3].
Table 3.
Comparative analysis of novel blood bag system with standard blood bag system
| Serial number | Parameters | Novel blood bag system | Standard blood bag system | P + |
|---|---|---|---|---|
| 1 | Donor’s response | |||
| 1.a | ‘Minimum’ – nil | ‘Minimum’ – 73.3% (22/30) | - | |
| Needle penetration force | ‘Moderate’ - 90% (27/30) | ‘Moderate’ - 26.6% (8/30) | 0.000006 | |
| ‘Severe’ - 10% (3/30) | ‘Severe’ - 0% (0/30) | - | ||
| 1.b | ‘Mild’ – 6.67% (2/30) | ‘Mild’ - 90% (27/30) | <0.000001 | |
| Pain associated with needle prick | ‘Moderate’ - 70% (21/30) | ‘Moderate’ -10% (3/30) | 0.000007 | |
| ‘Severe’ - 23.3% (7/30) | ‘Severe’ - nil | - | ||
| 2 | Phlebotomist’s response | |||
| 2.a | ‘Minimum’ – nil | ‘Minimum’ - 90% (27/30) | - | |
| Needle penetration force | ‘Moderate’ - 90% (27/30) | ‘Moderate’ - 10% (3/30) | 0.000009 | |
| ‘Severe’ - 10% (3/30) | ‘Severe’ - nil | - | ||
| 2.b | Donor facial expression (Facial grimace ) | ‘Present’ - 83.3% (25/30) | ‘Present’ - 60% (18/30) | 0.04* |
| 2.c | Label printing | ‘Neutral’ - 100% | ‘Neutral’ - 100% | 1.00* |
| 2.d | Needle protector (Rigid) | ‘Neutral’ - 100% | ‘Neutral’ - 100% | 1.00* |
| 2.e | Force needed to break the valve | ‘Mild’ - 100% | ‘Mild’ -100% | 1.00* |
| 2.f | Sample collection from diversion pouch | ‘Neutral’ - 100% | ‘Neutral’ - 100% | 1.00* |
| 2.g | Kink resistance of the tubing | ‘Neutral’ - 100% | ‘Neutral’ - 100% | 1.00* |
| 3 | Technical staff’s response | |||
| 3.a | Total time taken for extraction (hours) | 5.8 +/- 0.4 | 4.8 +/- 0.6 | < 0.0001 |
| 3.b | Any deviation during component separation | 23.3% (7/30) sealing error reported | 13.3% (4/30) sealing error reported | 0.16* |
| 3.c | Any deviation during storage of components | None reported | None reported | - |
| 4 | Quality indicators of prepared blood components | |||
| 4.a | PRBC [Mean +/-SD (95% CI)] | |||
| 4.a. 1 | PRBC volume (ml) | 274±30 (244-304) | 276±34 (242-310) | 0.8099 |
| 4.a. 2 | Hematocrit % | 53.4±5.7 (47.7-59.1) | 55±5.8 (49.2-60.8) | 0.2856 |
| 4.a. 3 | Hemoglobin per unit | 58.86±3.6 (55.2-62.5) | 60.17±7.31 (52.86-67.48) | 0.3822 |
| 4.b | FFP (Fresh Frozen Plasma) [Mean±SD (95% CI)] | |||
| 4.b. 1 | Plasma volume (ml) | 208±32 (180-232) | 212±28.5 (188-236) | 0.611 |
| 4.b. 2 | PT (in seconds) | 11.04±2.02 (9.6-13.01) | 11.68±1.99 (9.72-13.6) | 0.4896 |
| 4.b. 3 | APTT (in seconds) | 32.18±3.03 (29.5-35.2) | 31.4±2.93 (28.5-34.1) | 0.3213 |
| 4.b. 4 | Factor VIII (% activity) | 100% reported>200% activity | 100% reported>200% activity | 1.00 |
| 4.c | PC (Platelet Concentrate) [Median (Range)] | |||
| 4.c. 1 | Platelet volume (ml) | 76 (61-95) | 74 (76-90) | 0.7385 |
| 4.c. 2 | Platelet count (*1010/unit) | 6.9 (1.5-10) | 7.2 (2.1-9.2) | 0.1148 |
| 4.c. 3 | WBC count (*108/unit) | 0.42 (0.6-0.27) | 0.38 (0.26-0.52) | 0.2588 |
+Statistical test used was t-test analysis (paired & unpaired), P≤0.05 was considered statistically significant. *Statistical test used was Chi square test of independence, P≤0.05 was considered statistically significant
Donor responses
Of the study group donor population, 50% reported the needle prick to be more painful than previous experiences, compared to 10% of the control group, and this finding was statistically significant (P = 0.0007, Chi-square test of independence). The questionnaire-based responses are described in Table 3. The needle penetration force (as felt by the donors) and pain associated with needle prick were significantly higher in the study group than control group (P ≤ 0.05).
Phlebotomist’s responses
The questionnaire-based phlebotomist’s responses were divided into two groups, procedure related and donor experience related, and are recorded in Table 3. A statistically significant higher percentage of phlebotomist responses reported high needle penetration force while performing donor phlebotomy using the novel blood bag system (P ≤ 0.05). Facial grimace was noted on a higher percentage of donors of the study group (P = 0.04).
Technical staff’s responses
A higher rate of sealing error was reported in the novel blood bag systems during component separation, but the difference was not statistically significant (P > 0.05, Chi-square test of independence).
Finally, the blood components prepared from both the case and control groups were analyzed for the different quality parameters till their shelf life or issuance to the patient. There was no difference in quality of blood components stored in both types of blood bag systems.
Discussion
Selection of a novel blood bag involves quality checks as per the national and international guidelines (ISO 3826:2006) and prescribed quality Standard Operating Procedure manuals in the department.[4,5] No differences were observed between the two different blood bag systems for sterility and various ISO 3826:2006 variables. In this study, all the individual responses were reviewed, and the suitability of the blood bag systems for use was determined from three different standpoints, i.e., donor experiences, phlebotomist experiences, and technical staff experiences. It is significant to note that individuals with good expertise and experience were selected for their responses to ensure better adherence to the monitoring of quality of processes, with an extremely small margin of error.
It has been suggested in previous studies that the insertion and removal of a phlebotomy needle are associated with a higher incidence of donor vasovagal response.[6] There is a relation between locally applied force and the motion of the needle through the tissue.[7] In the present study, a higher percentage of regular repeat donors reported that the phlebotomy associated with the novel blood bag system was more painful as compared to their previous experiences (50% vs. 10%) (P < 0.05). A significant percentage of donor responses in the study population reported the needle prick to be more painful than their previous experiences, as well as a higher needle penetration force was experienced by them. The above donor responses corroborated with the phlebotomist ones as a significantly higher percentage of phlebotomist responses mentioned that more needle penetration force was applied for novel blood bag systems than that for routine blood bag systems. This puts the donor at a higher risk of phlebotomy-associated pain and tissue trauma.[4] Even though this study did not report any case of donor-related adverse event, a bad phlebotomy experience may exacerbate the risk of it or needle phobia among the donors. A good donor experience is important to retain the ever-precious voluntary donor pool.
The component preparation technical staff’s responses were also noted for ascertaining the suitability of the novel blood bags.[8] The present study did not find any increase in the rate of adverse events or deviations in these novel blood bag systems compared to the routinely used counterparts with regard to component separation, storage conditions, quality control indicators, and transfusion-related adverse reactions in patient population. Different salient features that may be considered when evaluating the blood bags include: their ability to withstand hard spin and soft spin, adherence of red cells to blood bags, compatibility with standard sealing and sterile connecting devices, sustenance of different labels (including base label and other unique identification labels) at different temperatures, absence of leaks after storage, ability to sustain storage at different temperatures, visibility (eye-readable) and sustainability of segment numbers, acceptability to end users, accessibility of ports for connecting transfusion sets, and breakage rates among others. A higher percentage of sealing error was reported in the novel blood bag systems, but that was not statistically significant.
Conclusions
From the above considerations, an objective evaluation of the new blood bag system was possible, and it can be suggested that the novel blood bag system had certain limitations with regard to the phlebotomy and needle characteristics which might have affected the donor and phlebotomist’s experience, but the blood components did not deviate in quality parameters, and they met the requirements of the national standard bodies. It is advisable to perform a similar and suitable evaluation of any newly procured reagent and supply item before introduction to the blood transfusion services.
Conflicts of interest
There are no conflicts of interest.
Acknowledgment
We would like to acknowledge the immeasurable support of all the staff at our blood center, who are actively engaged in continuous quality improvement by constantly providing suggestions and partaking in regular training sessions. We would also like to thank the highly motivated regular voluntary blood donors for the immense support for maintaining the blood inventory at our blood center.
Funding Statement
Nil.
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