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 Table of Contents  
Year : 2022  |  Volume : 7  |  Issue : 2  |  Page : 115-122

Clinical audits – A quality improvement tool in transfusion medicine

Department of Pathology, Pramukhswami Medical College and Shree Krishna Hospital, Bhaikaka University, Karamsad, Gujarat, India

Date of Submission07-Jul-2022
Date of Decision05-Aug-2022
Date of Acceptance10-Aug-2022
Date of Web Publication5-Nov-2022

Correspondence Address:
Monica Gupta
Department of Pathology, Pramukhswami Medical College and Shree Krishna Hospital, Bhaikaka University, Karamsad, Gujarat
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/gjtm.gjtm_54_22

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A clinical audit is a quality improvement process that seeks to improve services and outcomes through a systematic review of care against explicit criteria. It is now a recognized tool for improving clinical quality of care. However, in transfusion medicine, they have been utilized in a limited manner. This review intends to discuss the methodology of carrying out a clinical audit systematically. Clinical audit is not research and focuses on the improvement of ordinary and routine practices. Various methodologies for selecting and prioritizing a good audit topic can be employed. Based on the Donabedian model, process-based audits from donor selection to the actual bedside transfusion could be audited to bring in improvement. Likewise, transfusion processes can be audited based on the dimensions of quality in the context of timeliness, effectiveness, and appropriateness. Prioritization of a topic can be done through a quality impact assessment. The objectives help quantify the aim of the audit, while the standards include criteria that are quantified against targets, based on the current evidence for the best possible care. A snapshot sample (20–50 cases) is sufficient to carry out a clinical audit. Where targets are not met, root-cause analysis and quality improvement tools guide the implementation of changes in transfusion practices. To ensure that change is implemented and internalized, it is necessary to have the entire team and the management on board; communication with all stakeholders is key. Re-audit, after the change has been internalized, is an essential part of all clinical audits. Meticulously planning and proper implementation ensure improvement of the care that transfused patients receive.

Keywords: Clinical audit, quality improvement, standards-criterion-target-evidence, transfusion medicine

How to cite this article:
Gupta M, Ranapurwala MF. Clinical audits – A quality improvement tool in transfusion medicine. Glob J Transfus Med 2022;7:115-22

How to cite this URL:
Gupta M, Ranapurwala MF. Clinical audits – A quality improvement tool in transfusion medicine. Glob J Transfus Med [serial online] 2022 [cited 2023 Mar 30];7:115-22. Available from: https://www.gjtmonline.com/text.asp?2022/7/2/115/360488

  Clinical Audit Top

Interest in the audits of transfusion medicine (TM) has increased recently, not only because of increased awareness that transfusion carries risk to the patients but also because inappropriate transfusion practices are costly.[1]

A clinical audit is a quality improvement process that seeks to improve patient care (transfusion services) and outcomes through a systematic review of care against explicit criteria (standards). Where indicated, changes are implemented, and further monitoring is used to confirm improvement in healthcare delivery.[2],[3]

The use of clinical audits for continuous quality improvement in transfusion therapy has been demonstrated by various researchers worldwide.[4],[5],[6]

  Clinical Audit versus Research Top

Research is concerned with discovering the right thing to do, audit with ensuring that it is done right.[7] as outlined in [Table 1].[8]
Table 1: Research versus clinical audit[8]

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  The Audit Cycle Top

The main stages of the clinical audit cycle are shown in [Figure 1][9] and are described below.
Figure 1: The audit cycle[9]

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Selecting a topic

Adequate thought and meticulous planning are required for selecting a topic for audit, relevant to local practices while being mindful of time and resources.[1] Evidence indicates that most benefit is derived from small-scale clinical audit projects designed by local teams. Low-hanging fruits should be picked up for audits.

Major areas of concern in transfusion services, as expressed by numerous hemovigilance reports[10],[11] throughout the world, have been:

  1. Patient identification and labeling of pretransfusion samples
  2. Clinical use of blood components rationally
  3. Right blood to the right patient.

However, audit topics may be selected using any of the following approaches:

  1. The Donabedian model[12] [Figure 2] involves identifying indicators of structure, process, and outcomes. Clinical audits usually focus on processes rather than structure (requires management inputs) and outcome (discussed in Hospital Transfusion Committee, etc.)
  2. Patient care pathways from admission through discharge which involve transfusion of blood or blood products can also be audited
  3. Yet, another approach is to pick up topics that focus on any of the seven domains of quality in patient care [Table 2].[13],[14],[15],[16],[17],[18],[19]
Figure 2: Donabedian model for assessment of quality of care in transfusion medicine[12]

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Table 2: Selecting an audit topic in the context of domains of quality in healthcare with examples pertaining to transfusion medicine

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Prioritizing audit topics

Proposed audit topics should be prioritized in a systematic way to make the best use of time and resources. A scoring system using a locally developed grid (quality impact analysis) helps to rank topics in order of importance, as outlined in [Table 3].[20]
Table 3: An example of the scoring system for topic identification and prioritization, adapted from the clinical audit resources by University Hospitals Bristol and Weston National Health Service Foundation Trust

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Agreeing upon standards

Once the topic has been selected, the next step is to set an audit aim, objectives, and standards.

  • Aim: The aim defines the overall purpose of the audit and states what should happen as the result. Clinical audits are essentially quality improvement projects, and therefore, it is good to phrase the aim positively by using verbs such as “To improve…,” “To enhance….,” To change…,” and “To reduce….” The aim needs to be broken down into a series of smaller objectives[21]
  • Objectives: The objectives are the steps that need to be taken to assess whether the aim has been achieved [Figure 3]. They are written as specific tasks to be undertaken or as the different aspects of quality that the project will address[21]
  • Audit standards: Standards are quantifiable statements detailing the specific aspects of patient care and/or management that one intends to measure current practice against. They are more specific than objectives [Figure 3]. They seek to ensure that the best possible care is provided, given the available resources. The standards should be based on best practices evidenced through national/international/local guidelines, available literature, expert committee reports, or even local consensus reports. Criteria along with defined targets and exceptions and the evidence that they are based upon make up a standard are outlined in [Table 4][21]
  • Audit criteria: The audit criteria quantify the practice outlined in the objectives, describing in a measurable way what care should be delivered. The audit criteria should be derived from the source of evidence (column d)
  • Target: When writing audit standards, it is normal to set the target at 100%, i.e., the standard statement is something to be done always; the theory is that, if this is best practice, everyone is entitled to receive it. The target can be set at less than 100% when comparing outcomes against published evidence, and the established benchmark is not at 100%. The target is set at 0% while referring to something one will never do
  • Exceptions: Exceptions are justifiable reasons for not adhering to the defined criterion.
  • Source of evidence: This is the strongest, most up-to-date evidence of what constitutes best practice.
Figure 3: Writing the audit proposal

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Table 4: Audit standards[21]

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An example of a standard is outlined in [Table 5].[22]
Table 5: Setting standards: Hematology audit template of compliance with the updated British Society of Haematology guideline on the use of fresh frozen plasma and cryoprecipitate products in patients without major bleeding

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Data collection

Sample size

Contrary to research, a clinical audit needs to determine if practice complies with standards. A “snapshot” sample (roughly 20–50 cases) is usually sufficient for process-based audits. However, the sample must include current or recent patients. Rarely does one need to look at a practice of more than 12 months ago unless for a specific reason like a rare procedure/specific follow-up.[23]

Sample size calculators are also available to help determine the appropriate sample size; one example is suggested in [Figure 4].[24] For example, for an audit involving the consenting process of all blood donors, if the blood center has close to 5000 donations (audit population) in the said audit interval, at least 357 donor forms (sample size) need to be audited to ensure that you have covered enough donor forms to provide you with an accurate representation of the blood center donor pool.
Figure 4: Sample size calculator that gives an estimate of the sample size required to be 95% confident that the sample will give results within 5% of the audit population[24]

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Sampling methods

Commonly used sampling methods may be employed for sampling:

  • Random sampling assumes that the audit population will remain the same throughout the audit period and that each subject will have an equal chance of being chosen, either by drawing names out of a hat or choosing every nth subject from a list (e.g., choosing every 3rd or 5th donor)
  • Interval sampling assumes that the audit population will change throughout the audit. In these circumstances, the audit sample is often determined by a period, e.g., all patients transfused during May and June.
  • Consecutive sampling: Is a sampling technique in which every subject meeting the criteria of inclusion is selected until the required sample size is achieved
  • Stratified sampling ensures that proportions of different groups in the population are reflected in the sample. For example, if investigating donor deferrals, and male blood donors make up 40% of the donor population, 40% of included samples will have to be male
  • Rapid cycle sampling is used when there is a problem, to get results quickly. Small sample size is selected to assess the problem. Changes are implemented and a re-audit is done with another small sample to assess if improvements have been made. Lots of small data sets are used to continually improve and monitor care to make the change cycle quicker.
  • Convenience sampling is a nonscientific method of sampling where the most convenient sample available is included. For example, if for interviewing donors, donors available at the time of the interview are picked.

One must ensure that only relevant and necessary data are collected, which is aligned with the audit aim and defined standards. A data matrix is useful in this context [as outlined in [Table 6]].
Table 6: An example of a clinical audit in transfusion medicine at our blood center. Only the first cycle has been completed. plan for the second cycle is incorporated

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Audit tools are used for robust data collection and could be in the form of paper forms, web-based forms, spreadsheets, or databases.[25] We have personally found web-based forms (“Google Forms”) extremely useful because they indicate mandatory fields, permit quick data collection and analysis, and save precious time and resources. The audit tool must contain relevant information pertaining to the audit with clear instructions for filling and returning the form. The questions should be clear and unambiguous. The data collection tool must be piloted by filling up one or two forms. One might encounter that the instructions on the form or the questions asked are ambiguous; the form is difficult to complete; occasionally, relevant information is not being captured.

Compare data with standards

Once the data have been collected, they should be compared to the standards provided. For each standard, assess if the criterion is met as per the target. Where the targets are not met, identify the reasons and see if the reason is acceptable (as per the exception criteria). For standards close to 100% of the target, any further improvement might be difficult; instead, it makes sense to work on standards with lower results. The results and comparison may be displayed using different tools.[26]

Recommending and implementing change

Implementing change is the most difficult part of the cycle and the point at which projects are most likely to lose momentum. All efforts must be made to fully understand the fundamental reasons for the shortfalls identified. There may be an opportunity to use root-cause analysis (RCA) and related techniques to explore this further.[14],[27],[28] The change process includes initiation, implementation, and very importantly continuation.

A strategic plan could be drawn to implement change using any of the tools [Figure 5].
Figure 5: Examples of tools for change analysis

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While implementing, change should be broken down into manageable tasks with achievable targets. One must focus on training and development. Remember that communication with stakeholders is key. Pilot the change you wish to implement by a common model of improvement that involves the PDSA cycle, as outlined in [Figure 6].[29]
Figure 6: The model of improvement with the quality improvement cycle[29]

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Re-audit is necessary to ensure that changes become systemic and should be carried out after the appropriate time to permit changes to settle in. Staff should be taken on board by providing evidence that the changes have had a positive impact through a re-audit. Once again, communication is crucial, both with participating teams and with management.

To ensure a successful audit, remember

One should start from small audits and involve all team members and the management from the stage of planning to implementation of change. One must ensure the audit measures care against a standard. Appropriate sample size should be selected. The audit tool should be piloted. The analysis of data should be simple. The audit is completed only after the desired change is implemented and re-audit is carried out.

An example of a clinical audit carried out to improve the clinical use of platelets at our center is shown in [Table 6].

  Clinical Audits in Transfusion Medicine – Are They Worth The Effort? Top

Evidence-based medicine practices, as provided by clinical audits, have been critiqued by some researchers.[30],[31] Many reports indicate, however, that blood transfusion audits are important for the quality improvement of transfusion services in hospitals. This includes their effectiveness in identifying and in turn reducing inappropriate transfusions, improving bedside blood administration procedures, reducing unnecessary crossmatch tests, reducing outdating of donor blood, and avoiding the risk of blood shortages by providing information on service quality levels, profitability, and development.[32],[33] Clinical audits in TM, therefore, have assumed focal positions as quality improvement tools and pillars of clinical governance.[34],[35],[36],[37]

  Conclusion Top

Audits, can effectively improve routine practices in transfusion medicine and lead to better transfusion practices, patient care, safety, and outcomes by engaging and building teams in the improvement process and ensuring that change is internalized through re-audits. Blood centers and clinicians must engage in clinical audits in a structured manner, add to the existing evidence on quality improvement of routine practices, and make their contribution towards better “everyday” transfusion practices and services.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

  References Top

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  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]


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