Strengthening quality management system: An assessment of awareness and knowledge in trainees in blood bank.

OBJECTIVES: The objective of this study was to assess the changes in knowledge concerning quality management system (QMS) among the participants before and after attending a QMS training.
METHODS: After obtaining the ethical approval, a retrospective study was designed to evaluate the effectiveness of QMS. Fifty participants from district blood banks of three different states participated in the study organized at two different periods. After obtaining informed consent, the participants were subjected to set of questionnaire containing 45 questions (35 multiple choice and 10 subjective questions) as pretest on quality standards and were again subjected to posttest questionnaire containing the same set of questions after 5 days of workshop. Twenty minutes were granted to solve the questions. Each question was given one mark. There was no negative marking. An assessment of knowledge gained during training was evaluated by comparing the scores of pre- and post-assessment.
RESULTS: Of the total 50 delegates, 29 were trained in the month of July (Training I) and 21 were trained in the month of November (Training II). There were 96% (n = 48) males and 4% (n = 2) females. In both the training sessions, that is, Training I and II, the mean scores of objective questions in pretest were 13.629 ± 6.58 and 9.34 ± 5.74, and after the training, the posttest scores increased significantly to 17.77 ± 7.05 and 14.34 ± 7.09, respectively. Paired Student's t-test was applied which showed statistically significant increment in knowledge (P = 0.001).
CONCLUSIONS: There was a significant positive change in the knowledge of the participants after attending QMS workshop. Copyright:

Introduction

The blood transfusion services are an essential component of health-care system that works with a motive to ensure availability, accessibility, and adequacy to provide quality blood products. Transfusion of blood is a life-saving procedure. At every step from donor screening to transfusion of blood unit required a quality management system (QMS) and any lowering in quality would reflect adversely on the final product. Profound theoretical and practical knowledge is required to ensure the optimal clinical use of blood and blood products.[12] Various studies have been conducted to assess knowledge and practice of blood transfusion among medical personnel and nursing staff suggesting that the lack of training in transfusion practices is detrimental to patient safety.[34567] The competent performance in transfusion medicine becomes an essential requirement to prevent possible complications and transfusion reactions as lack of knowledge in this field can reduce transfusion safety and can cause significant harm to the patient.[8] Based on the principle of delivering quality health-care services, the National Blood Transfusion Council (NBTC) and the National AIDS Control Organization (NACO) have conducted baseline assessment of NACO supported blood bank and concluded that many blood bank in the country are not aware of the standard quality management practices for various procedures that are performed in blood transfusion services.[910] To achieve the quality in blood transfusion services, the NACO conducted training sessions on strengthening QMS at its recognized nodal training centers. Trainings are aimed first to enhance the knowledge of the individuals and later to monitor the improvement thereof in the service where the trainings have focused. The objective of this study was to assess the changes in knowledge concerning QMS among the participants before and after attending a QMS training.

Methods

After obtaining the ethical approval from the Institutional Ethical Committee, a retrospective study was designed to evaluate the effectiveness of QMS. Fifty participants from district blood banks of three different states Madhya Pradesh, Bihar, and Jharkhand participated in the National QMS workshop organized at two different periods of time at the Department of Transfusion Medicine, Bhopal Memorial Hospital and Research Center, Bhopal, which is a recognized nodal training center for NBTC and NACO, in the month of July 2017 and November 2017. For the convenience of analysis, the training in the month of July including the participants of Madhya Pradesh was named as Training 1 and training in the month of November including the participants of Jharkhand and Bihar was named as Training II. After taking informed consent from the participants, they were subjected to a predesigned questionnaire on quality standards containing questions on relevant topics of the workshop which were approved by the NACO and sent by the QMS training team of NACO.[9] The workshops conducted were of 5 days, respectively, covering the basics of QMS in blood banks through lectures delivered by experts as well as group activities and interactive sessions. The participants were again subjected to posttest questionnaire containing the same set of questions. Twenty minutes were granted to solve the 45 questions containing 35 multiple choice questions (MCQ) and 10 subjective questions. Each question whether MCQ or subjective was given one mark. The MCQs were evaluated on the basis of choosing the correct choice of answer, whereas all the subjective questions were evaluated on the basis of standard answer sheet, and after summing up the scores, the subjective questions were graded on a three-level scale of minimum knowledge (0–5 marks), medium knowledge (5–10 marks), and adequate knowledge (10–15 marks). There was no negative marking. An assessment of knowledge gained during training was evaluated by comparing the scores of pre- and post-assessment.

Statistical analysis

Statistical analysis was done for calculations of means, percentages, and ranges. The comparison of means was done using paired sample Student's t-test at 95% confidence interval, and P < 0.05 was considered statistically significant.

Results

Of the total 50 delegates, 29 delegates were trained in the month of July (Training I) and 21 delegates were trained in the month of November (Training II). There were 96% (n = 48) males and 4% (n = 2) females. All participants consented to fill the pretest and posttest questionnaire, and informed consent was obtained from the participants. Combining the participants of both the training sessions, there were total 48% (n = 24) medical officers and 52% (n = 26) laboratory technicians registered as participants [Table 1]. Figure 1 represents that, in both the trainings (Training I and II), the mean scores of objective questions in pretest were 13.629 ± 6.58 and 9.34 ± 5.74, and after the training, the posttest scores increased to 17.77 ± 7.05 and 14.34 ± 7.09, respectively. The mean pretest scores of objective questions of laboratory technicians and medical officers were 13.92 ± 5.37 and 20.18 ± 4.60 and were increased to mean posttest scores of 21.9259 ± 4.62 and 23.0455 ± 4.64, respectively [Table 2]. The mean rise in the score of laboratory technicians and medical officers increased to 8.0% and 2.86%, respectively, with an overall rise in the scores of 4.6%. Paired Student's t-test was applied to find the significant difference before and after test, and statistically significant increment was seen in knowledge (P = 0.001).

Table 1

Demographic characteristics

Training Sessions	Features	Number of participants (%)
Training I	Male	27 (93.10)
	Female	2 (6.89)
	Medical officers	13 (44.82)
	Laboratory technicians	16 (55.17)
Training II	Male	21 (100)
	Female	0
	Medical officers	11 (52.38)
	Laboratory technicians	10 (47.61)

Figure 1

Mean correct knowledge before and after test in July and November

Table 2

Mean correct knowledge before and after test in Training I and Training II

Mean±SD		P
Pretest	Posttest
Training I	13.629±6.58	17.771±7.05	0.001 (HS)
Training II	9.343±5.74	14.343±7.09	0.001 (HS)
Total	22.971±11.81	32.11±13.42	0.001 (HS)
Laboratory technicians	13.9259±5.37033	21.9259±4.26006	0.000 (HS)
Medical officers	20.1818±4.60	23.0455±4.64	0.05 (S)

SD=Standard deviation, S=Significant, HS=Highly significant

As evident from Table 3, the scores of subjective questions were also increased significantly in both the training sessions. In Training I, maximum participants 96.55% (n = 28) had a pretest score the sum between 0–5 while they reduced to 48.27% (n = 14) in posttest, whereas none of the participants scored the sum between 11–15 in pretest and the achievement of this increased up to 10.34% (n = 3) in posttest. Similarly, in Training II, 95.23% (n = 20) maximum number of participants scored the sum between 0–5 which reduced to such an extent that no participant scored the minimum score of 0–5 in posttest, whereas the maximum scores of sum between11and 15, of the participants, increased from none in pretest to 38.05% (n = 8) in posttest [Table 4]. Chi-square test was applied to find the significant difference before and after test. There was a statistically significant increment seen in knowledge (P = 0.001).

Table 3

Pre- and post-subjective test scores (number range)

Number range	Training I (November n=21)		Training II (July n=29)
	Pretest (%)	Posttest (%)	Pretest (%)	Posttest (%)
0-5	20 (95.23)	0	28 (96.55)	14 (48.27)
6-10	1 (4.76)	13 (61.90)	1 (3.44)	11 (37.93)
11-15	0	8 (38.09)	0	3 (10.34)
Significance “P”	0.001 (HS)		0.001 (HS)

HS=Highly significant

Table 4

Overall increase in knowledge in both the groups

Paired sample (Post-Pre)	Paired differences (%), mean±SD	t	P
Laboratory technicians (Group I)	8.00000±8.03358	5.174	0.000 (HS)
Medical officers (Group II)	2.86364±6.50491	2.065	0.052 (HS)
Overall training	4.60000±6.26562	6.142	0.000 (HS)

SD=Standard deviation, HS=Highly significant

Table 5 suggests the comparison of the knowledge of subjective questions between medical officers and laboratory technicians in both the training sessions. The knowledge of subjective questions in medical officers was higher in Training I in pretest score and was found statistically significant whereas the posttest scores showed almost equal increment in the knowledge of both. However, in Training II, there was no significant difference between the knowledge of the medical officers and laboratory technicians in pretest as well as in posttest. While comparing both the scores of both the trainings, the participants in Training II showed a higher compatibility to the training as the rise in score is higher in Training II.

Table 5

Comparison of pre- and post-subjective test score in both the groups

Training sessions	Groups	n	Mean±SD
			Presubjective test scores	Postsubjective test scores
Training I	Laboratory technicians	16	1.44±1.263	4.13±4.064
	Medical officers	13	2.92±1.801	6.62±3.429
	Significance “P”		0.015 (S)	0.09 (NS)
Training II	Laboratory technicians	11	2.91±1.136	9.91±1.300
	Medical officers	10	2.70±1.337	9.80±1.619
	Significance “P”		0.703 (NS)	0.866 (NS)

S=Significant, NS=Not significant, SD=Standard deviation

As evident from Table 6, in Training sessions I and II, the pretest scores of Q13 and Q16 suggest that the delegates were well aware about the administrative part of the blood banks, including the knowledge of accessibility of standard operating protocol and quality of audit, whereas there was lack of knowledge in defining quality, implementation, intention, and direction of quality in blood banks. However, in posttest assessment, the knowledge about quality audit, blood storage, quality monitoring of blood components, documentation, stock control, and blood cold chain increased significantly as 82.75% delegates answered Q2, Q27, Q29, and 86.2% delegates answered Q16, Q24, Q25, Q30, and Q32 correctly in Training I, whereas in addition to some similar questions as in Training I knowledge about quality policy, document control, quality assurance, and assessment was significantly increased in Training II as 100% delegates answered Q8, Q15, Q21, Q22, Q23, Q25, Q27, and Q30 correctly.

Table 6

Question-wise scores of the participants in pre- and post-test assessment

Questions	Training I pretest (%)	Training I posttest (%)	Training II pretest (%)	Training II posttest (%)
Q1	6 (20.68)	20 (68.96)	6 (28.57)	0
Q2	23 (79.31)	24 (82.75)	16 (76.19)	14 (66.7)
Q3	5 (17.24)	1 (3.44)	0	15 (71.4)
Q4	7 (24.13)	19 (65.51)	5 (23.8)	13 (61.9)
Q5	7 (24.13)	20 (68.96)	9 (42.85)	0
Q6	14 (48.27)	16 (55.17)	6 (28.57)	13 (61.9)
Q7	1 (3.44)	5 (17.24)	4 (19.04)	10 (47.6)
Q8	10 (34.48)	12 (41.37)	10 (47.61)	21 (100)
Q9	3 (10.34)	18 (62.06)	2 (9.52)	3 (14.3)
Q10	18 (62.06)	23 (79.31)	14 (66.67)	3 (14.3)
Q11	9 (31.03)	4 (13.79)	8 (38.09)	20 (95.3)
Q12	8 (27.58)	5 (17.24)	0	20 (95.3)
Q13	25 (86.2)	23 (79.31)	18 (85.71)	18 (85.7)
Q14	17 (58.62)	19 (65.51)	17 (80.95)	21 (100)
Q15	7 (24.13)	7 (24.13)	8 (38.09)	21 (100)
Q16	24 (82.75)	25 (86.2)	19 (90.47)	18 (85.7)
Q17	16 (55.17)	23 (79.31)	8 (38.09)	7 (33.3)
Q18	14 (48.27)	17 (58.62)	5 (23.8)	14 (66.7)
Q19	6 (20.68)	12 (41.37)	2 (9.52)	6 (28.6)
Q20	11 (37.93)	20 (68.96)	4 (19.04)	13 (61.9)
Q21	12 (41.37)	12 (41.37)	5 (23.8)	21 (100)
Q22	6 (20.68)	10 (34.48)	5 (23.8)	21 (100)
Q23	18 (62.06)	22 (75.86)	19 (90.47)	21 (100)
Q24	19 (65.51)	25 (86.2)	15 (71.42)	14 (66.7)
Q25	21 (72.41)	25 (86.2)	16 (76.19)	21 (100)
Q26	18 (62.06)	23 (79.31)	9 (42.85)	13 (61.9)
Q27	19 (65.51)	24 (82.75)	16 (76.19)	21 (100)
Q28	17 (58.62)	19 (65.51)	6 (28.57)	17 (81)
Q29	17 (58.62)	24 (82.75)	12 (56.14)	17 (81)
Q30	19 (65.51)	25 (86.2)	11 (52.38)	21 (100)
Q31	16 (55.17)	17 (58.62)	9 (42.85)	20 (95.3)
Q32	22 (75.86)	25 (86.2)	17 (80.95)	19 (90.5)
Q33	16 (55.17)	23 (79.31)	11 (52.38)	1 (4.76)
Q34	20 (68.96)	23 (79.31)	7 (33.33)	19 (90.5)
Q35	6 (20.68)	12 (41.37)	1 (4.76)	1 (4.76)

Discussion

QMS is an integral part of blood banks as blood consists of living cells and is being used for pharmaceutical purposes and comes under the regulation of pharmaceutical production rules. The present study was aimed to assess the improvement in knowledge of the participants participated in QMS training. This training program in QMS was a predesigned activity-based training which incorporated the maximum involvement of the participants in the hands-on training, including group activities, homework assessments, interactive assessments, and laboratory demonstration including the quality issues related to blood banking. The training of clinical staff in blood banks is a national mandate and is being regularly conducted throughout the country. As there is paucity of studies related to the assessment of knowledge of the all clinical staff working in blood transfusion whereas no study has been published in India or abroad to find the effectiveness of these QMS training programs; however, the World Health Organization (WHO) reported a workshop conducted in Pakistan, 2014 on the WHO training on quality management and revealed an increment in knowledge of the delegates after an uniform workshop being organized at four different places of the country. The participants scored between 70%–80% in the postcourse assessment as compared with the scores 40%–50% in the precourse assessment.[11] The present study also revealed that there was a significant increase in knowledge among the delegates participated in both the training of QMSs as the scores increased from 46.99% to 61.82% in Training I and from 49.25% to 68.29% in Training II. Similarly, Kaur et al. in their study also reported the rise in the mean score of posttraining assessment to 85.4% from 51% in the pretraining, which was statistically significant while training the clinicians for transfusion practices.[12]

Clark et al. reported an improvement in compliance with the national guidelines to over 95% in six out of seven of the recommendations on the best practice was seen 18 months after the initial intervention and suggested that education is the primary requisite of those who prescribe and administer transfusions.[13]

As this is an era of evidence-based practice, regular workshops and their assessment become a mandatory to bring forth the ethics in clinical practices and ensure quality. Furthermore, various researches favor training and workshop and an important tool in medical education as well as for promoting ethical and evidence-based practice.[141516] The pre- and post-assessment of the workshop is an effective method to find the effectiveness of the training program or workshop module and also helps in improving the instructor's ability.[14] However, to assess the QMS training prospective research studies needs to be planned to fulfill the research gap.

Various studies have been conducted to assess the knowledge of interns and nurses in working or involved in transfusion services.[5617] Hijji et al. in their study reported a deficit of knowledge in the nurses working in blood transfusion services.[5] Similar results addressed in a survey conducted on Jordian nurses and were found detrimental to patient safety.[6] Further, a study conducted on nursing students showed a lack of knowledge in transfusion services, which was fund to be improved after training, similar to the present study.[17]

The Pyramid Model was also described as a tool to manage the quality systems, which include a four-level model including the quality policy, annual plans, job descriptions, standard operating procedures (SOPs) and emergency operating procedures description, and record maintenance.[18] The present study also included the questions related to quality policy, SOPs, documentations, and job responsibilities, and it was found that the participants were well compatible in maintaining documents, following SOP, and audits as between approximately 75% of participants answered the questions related to these topics correctly whereas they lacked in practical quality management. Furthermore, the participants lack information about the implementation, intention, and direction and overall organization in relation to quality as <41% of the participants answered the questions related to these topics. It is an essential requirement for quality, safety, and efficacy of blood and blood products to ensure well-equipped blood centers with adequate infrastructure and trained workforce. To ensure uniformly ethical practice, good quality practice, and effective clinical use of blood in blood banks, it is necessary to train clinical staff. While moving toward total quality management to attain maximum safety, the requirements of good manufacturing practices and implementation of the quality system have offered challenges to the organization and management of blood transfusion service.[9] This study also included the questions related to quality monitoring of processed blood component and safety issues such as maintaining blood cold chain, identification of patients, and about the storage area for blood and blood components, and it was found that the participants were well aware of these questions and majority approximately 60% and above answered the questions correctly in pretest assessment in both the trainings; however, the scores increased further after the training. Unlike this study, Hijji et al. in their study reported the lack of knowledge related to the appropriate identification of patients.[6]

The training in QMS along with the other quality issues and protocols also addresses the concept of hemovigilance. It is a continuous need to aware the transfusion team about hemovigilance to avoid undesired transfusion reaction and to keep the laws and tools in place.[19] The present study also addressed the concept of hemovigilance in training and <51% of participants answered the question correctly in pretest assessment while it improved to 84% after training.

Transfusion services in developed world such as the USA are highly costly and efficient; however, in the developing world like ours, transfusion therapy is facing the continuous concern related to blood safety issues.[20] The WHO has identified blood safety as a health issue requiring high priority and has developed a comprehensive program and guidelines to ensure the quality management in blood banks and also considered it important to provide comprehensive, appropriate, and effective training is for all blood transfusion service staff and other health-care professionals involved in blood transfusion which also includes the distance learning modules.[21]

In India, in spite of good training programs for QMSs in blood banks by NACO, the effectiveness of these QMS training programs has not been assessed and provides a research gap.[10]

Conclusions

There was a significant positive change in the knowledge of the participants after attending QMS workshop. This study will help to develop the roadmap to the implementation of QMS in blood banks to improve consistency in all its activities and aware the participants for the enhancement of quality of the blood banks. A prospective study can be planed and also a standardized questionnaire can be developed to implement similar assessment throughout the country. Thus, it would be helpful to facilitate to focus the course on areas of particular need.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.