Adaptation and validation of a scale for quality standards measures in hospital blood bank: A pilot study

doi:10.21203/rs.3.rs-5091620/v1

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Adaptation and validation of a scale for quality standards measures in hospital blood bank: A pilot study

https://doi.org/10.21203/rs.3.rs-5091620/v1

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Context: Applying quality standards in hospital blood banks helps to determine how the blood bank operates to meet the requirements of technical specifications with the requirements of national and international blood bank programs with accurate results and ensuring the safety and effectiveness of blood products for patients.

Aims: This study aims to measure the psychometric properties (content validity and reliability) of the “Scale” as newly adapted measure to assess the quality standards in the blood bank in hospitals.

Settings and Design: A pilot cross-section validation study conducted during the period from March to July 2023.

Methods and Material: This study included seven of experts as jury to assess the content validity of the scale. The thirteen blood bank personnel were included in the pilot testing of the reliability of it.

Statistical analysis used: The content validity index was calculated at the item level
(I-CVI), expert level (E-CVI) and scale level (S-CVI). Cronbach's alpha was calculated to measure the internal consistency between items of each domain and the total scale.

Results: Global I-CVI ranged between 0.85 and 1.0, S-CVIs was more than 0.90 and E-CVI ranged between 0.79 and 1.0. The internal consistency for personnel domain was with Cronbach’s α = 0.61 and 0.80.

Conclusions: The scales for place and processes are valid, and that for personnel is valid and reliable. The newly modified scale with three domains including 76 items can be used to measure and monitor the performance and quality standards in the hospital blood bank.

Blood bank

Quality

Content validity

This is the first study to describe and identify quantitative indicators of content validity of a new scale for performance assessment in a blood bank during the design and evaluation of quality standard measures in a hospital blood bank.

Hospital blood banks play the main role in the overall process of blood transfusion services as they are the link between the blood products and clinical blood users. The primary tasks of the hospital blood bank are to ensure accurate results of tests performed on blood and blood components as well as the safety and efficacy of these blood products for patients [1].

Quality is simply defined as 'conforming to requirements'. In a broader sense, it does the right thing at the right time, effectively and efficiently. This is achieved by introducing standard policies and processes used to achieve specific goals or requirements, then documenting how they were achieved, and the records required to prove that this happened [2].

The application of quality standards in hospital blood bank helps determine how the blood bank will operate to meet the requirements of the technical specification and compatible with National and International Blood Bank program requirement [3]. Standard precautions are needed for all processes in the blood transfusion services in order to prevent transmission of health care associated infection [4].

General Authority for Healthcare Accreditation and Regulations standards (GAHAR) are the essential step for improving quality of healthcare in Egypt. These consist of patient-centered standards and Organization-centered standards. Patient-centered standards are focusing on the communication of patient information to ensure correct and effective patient management plans. They cover most critical processes and provide the appropriate care in transfusion medicine [5].

Content validity is an important step in development of the scale, which is one of the components of construct validity. The content validity index (CVI) is the most common methods used to quantitatively calculate content validity [6, 7]. Content validity involves judgment by experts about whether a measure is valid or not and includes appropriate content to capture the concept under evaluation. An appropriate number of experts that is sufficient for the content validation ranges from a minimum of three to maximum of ten [8, 9]. Selection of the experienced appropriate experts to participate in the validation process can enhance the validity of the content and clarify the assessment instructions reduces expert biases that may affect content validity scores [7, 10]. To complete the validation process, the content validity should be studied and analyzed including reliability evaluation [11].

The first step in applying quality standards in blood banks is to evaluate the work performance in the blood bank. A structured evaluation tool “Scale” can ease this process and improve quality and work performance in blood transfusion services. To the authors’ best knowledge there is no validated tool to measure standards applied in the blood bank as well as the practice of blood bank workers in Egypt. This study aims to develop a structured valid and reliable scale to be used in the blood bank of Gastrointestinal Surgery Center in Mansoura University as well as other hospital blood banks.

This is a pilot cross-section validation study conducted during the period from March to July 2023. This study included seven experts as jury to assess content validity. All thirteen personnel working in a hospital blood bank were included in pilot testing of the reliability of the scale.

Data collection:

The evaluation scale was designed in line with the international, national and GAHAR standards for blood banks in hospitals [5, 12, 13], so that they can be ready to apply for the GAHAR accreditation in Mansoura University hospitals in the future. It consists of three main domains including 68 items in English language: The first is the Environment domain includes questions about place (24 items). The second is the Personnel domain includes questions about blood bank workers (16 items). The last is the Processes domain includes questions about the four subdomains of Donation process (8 items), Blood components Preparation process (8 items), Serological test process (3 items) and Issuing process (9 items).

Validation of the scale was assessed by Jury of seven experts specialized in blood banking, clinical pathology and quality management (six professors and one lecturer) to measure the content validity indices. Jurors evaluated the scale for clarity and relevance of each item, items of the three domains were rated on the 3-points Likert scale (1 = not clear or relevant, 2 = partially clear or relevant and 3 = clear or relevant).

The content validity index (CVI) was calculated at the item level (I-CVI), at expert level (E-CVI) and scale level (S-CVI). To obtain the CVI at the item level (I-CVI), the number of experts judging the item as relevant or clear (rating 3) were divided by the total number of experts. The CVI for each expert (E-CVI) is number of items scored 3 (relevant or clear)/total number of items. If the CVI is higher than 0.79, the item was appropriate. If it is less than 0.79, it needs revision. The CVI for the entire scale (S-CVI) was assessed using the S-CVI with the average approach, by summing all I-CVI for relevancy divided by the number of items. The scale as a tool was be considered to be valid if S-CVI greater than or equal to 0.90 [14, 15]. Expert comments on the statement such as rephrasing, separation of items or need for more detail were considered in the final version.

Internal consistency was assessed by Cronbach alpha coefficients (α), Cronbach’s α value of 0.50–0.70 was acceptable, whereas 0.70 or higher shows good homogeneity among the items [16, 17]. The pilot study was done to measure its reliability, when appropriate reliability for personnel domain and it wasn’t assessed for the environment and processes domains as there was one place and there wasn’t variation in the processes as it followed the current policy.

Ethical consideration:

This study was approved by IRB of Mansoura Faculty of Medicine, Mansoura University, with Code Number: MD.23.02.746. Personnel agreed to participate in the study and their data were kept confidential. Official approval was approved from hospital authority.

Statistical analysis:

Data were analyzed with SPSS version 23 (Armonk, NY: IBM Corp.) The content validity index was calculated at the item level (I-CVI), expert level (E-CVI) and sub-scale level (S-CVI). Cronbach's alpha was calculated to measure the internal consistency between items of each domain and the total scale [18]

Table 1 shows the content validity indices per items (I-CVI) for the environment domain, almost all items ranged (except 5 of 26 items) between 0.71 and 1.0 for relevance and clarity. The total sub-scale content validity indices (S-CVI) were 0.92 and 0.86 for both relevance and clarity; respectively. One item was eliminated, five items were revised and modified and two items were added referred to experts’ comment.

Table 1

Content validity indices of original scale (per item, and total scale) for both relevance and clarity of environment domain
Items	I-CVI		Items	I-CVI
Items	Relevance	Clarity	Items	Relevance	Clarity
Environment Domain
1.Is an approved policy & procedures for blood transfusion service available	1.0	1.0	6.Is the equipment available for blood bank meet the requirement	1.0	1.0
2.Is the area for blood donation maintain donor safety & privacy	0.857	0.714	7.Are there blood bags, tubes, reagent & supplies used for blood transfusion process meet the requirement	0.714	1.0
3.Is the storage condition for blood components under access controlled	0.857	0.571	8.Is an alarm system & a provision for alternate power supply available	1.0	1.0
4.Are there any expired consumable	1.0	0.667	9.Have blood bank physical separation between screened & unscreened blood units	1.0	0.857
5.Is the infrastructure suitable & safe for blood bank	1.0	0.571	10.Is the blood bank a separate department inside the hospital	1.0	1.0

Table 1

Content validity indices of original scale (per item, and total scale) for both relevance and clarity of environment domain (Contd.)
11.Are the used disposables sterile / single use	1.0	1.0	18.Is PPE available, easily accessible & appropriate to the task performed	1.0	1.0
12.Have the blood bank an appropriate inventory of blood on the shelf at all times	1.0	1.0	19.Are the biosafety plan, equipment & practice available	0.715	0.429
13.Is an approved policy & procedures for infection control program available	1.0	1.0	20.Are cleaning & disinfectant tools available	1.0	1.0
14.Are all environment in blood bank clear	0.286	0.143	21.Are clear instructions for dealing with biological material spills available	1.0	1.0
15.Are the hand hygiene facilities present in appropriate number & place	0.857	1.0	22.Is there an approved policy for waste management & waste disposal	1.0	1.0
16.Are the hand hygiene posters displayed in appropriate areas	1.0	1.0	23.Is a clearly labelled or color-coded bins in place to separate sharp wastes, infectious wastes & general wastes	1.0	1.0
17.Are the supplies for hand washing available	1.0	1.0	24.Is a storage room for waste meet national laws & regulations	1.0	0.857
Total sub-scale content validity index (S-CVI)		Relevance		Clarity
Total sub-scale content validity index (S-CVI)		0.929		0.929
Note: Item 14 was eliminated, items 2,3,5 were separated and item 19 was rephrased.

Table 2 shows the I-CVI for the personnel domain, all items ranged between 0.85 and 1.0 for relevance and between 0.71 and 1.0 for clarity. The S-CVI were 0.92 for both relevance and clarity. One item was eliminated and two items were revised and modified referred to experts’ comment.

Table 2

Content validity indices of original scale (per item, and total scale) for both relevance and clarity of personal domain
Items	I-CVI		Items	I-CVI
Items	Relevance	Clarity	Items	Relevance	Clarity
Personnel Domain
1.Is the director of blood bank a certified physician & well trained on blood bank activities	0.857	1.0	6.Are the blood bank staff members well trained on the tests & processes carried out on donated blood units	1.0	0.714
2.Are the blood transfusion services monitored by licensed qualified medical staff member	0.857	0.857	7.Are the qualified blood bank staff members well trained on the order process of blood	1.0	1.0
3.Is there a competence assessment process for blood bank staff member	1.0	1.0	8.Are the blood bank staff members aware about emergency order of blood	1.0	1.0
4.Are the blood bank staff members trained on quality manual & blood transfusion policy	1.0	1.0	9.Are the qualified blood bank staff members well trained on the compatibility test	1.0	1.0
5.Are the blood bank staff members well trained on pre donation counseling, donor assessment & post donation care	1.0	1.0	10.Is a healthcare professional responsible for interpretation of cross matching test results, resolve the discrepancy results & manage the special situation	0.857	0.857

Table 2

Content validity indices of original scale (per item, and total scale) for both relevance and clarity of personal domain. (Contd.)
11.Are healthcare professionals involved in blood transfusion process	0.857	0.714	14.Are all blood bank staff members properly using PPE	0.857	1.0
12.Is all blood bank staff trained on infection control program & biosafety plan	1.0	1.0	15.Can all blood bank staff members do cleaning technique, disinfection & dealing with biological materials spills	0.857	0.857
13.Are the blood bank staff members performing proper hand hygiene procedures	0.857	1.0	16.Are the blood bank staff members properly handling biohazards waste & properly segregating it.	0.857	0.857
Total sub-scale content validity index (S-CVI)		Relevance		Clarity
Total sub-scale content validity index (S-CVI)		0.929		0.929
Note: Item 11 was eliminated by expert suggestion

Table 3 shows the CVI for the process’s domain. Almost I-CVI of all items for donation processes ranged between 0.85 and 1.0 for relevance and clarity. The S-CVI were 0.96 and 0.91 for both relevance and clarity; respectively. The I-CVI for the blood component preparation processes was 1.0 for relevance and ranged between 0.71 and 1.0 for clarity. The S-CVI were 1.0 and 0.92 for both relevance and clarity; respectively. The I-CVI for the serology testing processes ranged between 0.85 and 1.0 for both relevance and clarity. The S-CVI were 0.95 and 0.90 for both relevance and clarity; respectively. Almost I-CVI of all items for issuing processes ranged between 0.85 and 1.0 for relevance and clarity. The S-CVI were 0.98 and 0.88 for both relevance and clarity; respectively. Two items were eliminated, two items were revised and modified and three items were added refereed to experts’ comment.

Table 3

Content validity indices of original scale (per item, and total scale) for both relevance and clarity of processes domain
Items	I-CVI		Items	I-CVI
Items	Relevance	Clarity	Items	Relevance	Clarity
Donation processes Subdomain
1.Has been a questionnaire used in donation process	0.857	0.714	5.Is there a unique number for the donor	1.0	0.857
2.Is a medical examination & Hb assessment done on the donors	1.0	1.0	6.Is blood/blood component collection & preparation based on national guidelines	1.0	1.0
3.Is the donor privacy maintained	1.0	1.0	7.Is infection control precaution & proper sterilization during blood collection	0.857	0.714
4.Is there blood donation record that contains complete donor information	1.0	1.0	8.Is there identification of blood/blood component bags & tubes	1.0	1.0
Total sub-scale content validity index (S-CVI)		Relevance		Clarity
Total sub-scale content validity index (S-CVI)		0.964		0.911
Blood component preparation process Subdomain
9.Is the cold chain maintained from donation & during transport of blood units	1.0	0.714	13.Is a temperature monitored & controlled for blood collection, preparation & storage	1.0	0.857

Table 3

Content validity indices of original scale (per item, and total scale) for both relevance and clarity of processes domain (Contd.)
10.Is the sealer used to maintain closed system in bags	1.0	1.0	14.Is there QC for each blood component done periodically	1.0	1.0
11.Are there labels of blood/blood component include all unit information & serological results	1.0	1.0	15.Is there a process of quarantine & release of blood/blood component	1.0	0.714
12.Are blood/blood component stored according to their specification	1.0	1.0	16.Are expired dates monitored & expired units managed effectively	1.0	1.0
Total sub-scale content validity index (S-CVI)		Relevance		Clarity
Total sub-scale content validity index (S-CVI)		1.0		0.929
Serology process Subdomain
17.Is the laboratory test for infectious disease	1.0	0.857	19.Is Rh typing & weak D test done	1.0	1.0
18.Is ABO grouping test done by direct & reverse technique	0.857	0.857
Total sub-scale content validity index (S-CVI)		Relevance		Clarity
Total sub-scale content validity index (S-CVI)		0.952		0.905
Issuing process Subdomain
20.Are the patient sample label & blood transfusion request complete with all required data & cross checked before issuing blood	1.0	0.857	25.Is monitoring of patient during transfusion recorded in patient medical record	1.0	0.857

Table 4 show The CVI per expert (E-CVI) for all domains. The E-CVI for the environment domain ranged between 0.79 and 1.0 for relevance and between 0.79 and 0.95 for clarity. The E-CVI for the personal domain ranged from 0.75 to 1.0 for relevance and from 0.68 to 1.0 for clarity. Almost the E-CVI for the process’s domains ranged between 0.87 and 1.0 for relevance and clarity.

The Cronbach’s alpha of personnel domain was good and the result ranged between 0.61 and 0.80. Finally, at the end of the content validity, the scale was prepared with three domains and 76 items (data not shown in tables) for use in future studies.

The main goal of blood transfusion services is to promote high quality standards in all aspects of production, patient care, and service. The quality system in blood banks includes organizational structure, responsibilities, policies, processes, procedures and resources [19]. It is important to promote the highest levels of quality in all aspects to ensure safe blood collection procedures, correct testing for transfusion transmitted infections (TTIs), accurate blood grouping and compatibility testing, appropriate use and safe blood administration [20]. Evaluating quality standard measures and performance in blood banks is the cornerstone to ensure that appropriate tasks are performed and related problems are monitored efficiently and effectively [21, 22].

This study describes and identifies quantitative indicators of content validity of a modified scale for performance assessment in a blood bank during the design and evaluation of quality standard measures in a hospital blood bank. It revealed CVI for all items of the scale, and the results were acceptable and good in terms of relevant and clarity, as it was found that most of the I-CVI ranged between 0.85 and 1.0, the S-CVI was more than 0.90 [14, 15]. The items with I-CVI below 0.70 were revised and modified. Exclusion of four items that were extreme lowest CVI (< 0.50) from the entire scale, and according to the experts’ suggestion, five items were added to cover the missing points in the evaluation process of the performance and the quality standards in blood banks. The number of seven experts was considered adequate for content validation and the most of E-CVI ranged between 0.79 and 1.0 [8, 9].

There are some previous studies on the content validity of the tools used in blood bank [23–24], and there is some agreement with our results. Similar finding was observed in a study by Bezerra CM, et al. [23], to describe the process for creating and validating a scale for blood transfusion in children, the contents were considered valid with global CVI 0.87 and the items of CVI below 0.80 were deleted or replaced and other items were added.

After extensive literature review, we did not find any previous similar studies to compare with. However similar studies on other scales using the I-CVI had results consistent with ours [25–27], such as the I-CVI study of the COVID-Specific Stress Scales (CSS) - Arabic, ranged between 0.81 and 1.0 at different levels. The items were assessed by 22 judges and the E-CVI ranged between 0.72 and 1.0 on items varying in terms of relevance and clarity. The S-CVIs were 0.94 and 0.93 for relevance and clarity, respectively [25]. And also, the content validity of the Process Evaluation Scale (PEC), which was adapted as a measure to evaluate the fidelity of the Evidence-Based Practice Identification and Change (EPIC) intervention, was conducted by eight of 19 experts. The I-CVIs ranged between 0.6 and 1.0 and S-CVIs ranged between 0.3 and 1.0 and two items were deleted while nine items were retained [26].

The current study revealed that the Cronbach alphas of the personal domain is satisfactory and the result was 0.61 and 0.80. On pervious study, the Cronbach's alpha coefficients for the CSS scales were > 0.80, indicating good to excellent [25]. While, the reliability of the scales was selected out of the required competencies of Medical-Surgical Nursing course during academic year (OSCE) was acceptable, seven out of the tested ten scales were reliable while all the scales were valid as the result ranges between 0.23 and 0.63 [28].

Limitations:

Some limitations of content validity studies should be noted. This type of study may be subjected to bias that may exist among experts. Therefore, the content domain is well defined and the experts are asked to suggest other items that may help minimize this limitation [29]. Reliability was not examined for the environment and processes domains because it is a single place and one official policy for the processes.

The present scale with three domains and including 76 items helps measure the performance and quality standards in the hospital blood banks. The scales for place and process are valid, and that for personnel is valid and reliable. The newly adapted scale is ready for use in the next steps.

Validated tool can used by students, researchers, policy makers and clinical staff to evaluate blood banks at levels of place, personnel and processes. A large-scale multicenter study is recommended to further confirm validity of the scale on larger sample size of population to enable confirmatory factor analysis.

Data availability statement:

The validated scale is available from the corresponding authors upon request.

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The authors declare no competing interests.

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Adaptation and validation of a scale for quality standards measures in hospital blood bank: A pilot study

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Introduction:

Subjects and Methods:

Data collection:

Ethical consideration:

Statistical analysis:

Results:

Discussion:

Limitations:

Conclusion:

Declarations

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References

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