Auditing Process for Medical Testing Laboratory

Introduction

Auditing is a fundamental process of a quality management system. Auditing allows the process systems of a medical laboratory to be continually examined. The performing of audits by medical laboratories will ensure “the pre-examination, examination and post-examination and supporting processes are being conducted in a manner that meets the needs and requirements of users” (ISO, 2018) Audits allow the continued maintenance and improvement of quality within the medical laboratory setting.

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There are two main types of audits. These are internal audits and external audits. An internal audit provides medical laboratories assurance that their risk management, governance and internal control processes are operating effectively. Internal audits are performed throughout the year. An internal audit is performed by a laboratory on its own systems (Iia.org.uk, 2018).  An external audit is performed by an independent third party. The process of external auditing is crucial to medical laboratories as it will determine their compliance to international standards such as ISO 15189. An external audit is usually conducted once a year (ISO,2018). In Ireland, external audits on medical laboratories are usually performed by the Irish National Accreditation Board (INAB, 2018).

The process of auditing involves two main strategies. These are horizontal and vertical audit strategies. Medical laboratories should use both these strategies when performing audits. A vertical audit involves the checking of all aspects of a quality system within an area (Hammar, 2018). An example of a vertical audit within a medical laboratory is following a patient sample from collection to the issuing of the final authorised report. A vertical audit evaluates more than one process on a single item. A horizontal audit is when one process is audited across many departments in an organisation (Hammar, 2018). An example of a horizonal audit within the medical laboratory is checking patient reports from different laboratory disciplines to ensure that they all contain the required information

This assignment requires us to ‘Critically evaluate the audit and suggest any improvements which could be applied to the audit’. This is an example of a vertical audit. This audit will assess the processes involved in the receipt of the biochemistry sample for gentamicin testing through to the issuing of the final report. A vertical audit involves the evaluation of eight different operations. These include the following:

-          The competency of staff

-          Sample records

-          Procedures used

-          Quality control

-          Maintenance records

-          Environmental conditions

-          Reliability of results

-          Storage and disposal practices

(Goetsch and Davis, 2013).

Audit

Audit Scope

This audit was performed in a clinical biochemistry laboratory where a patient sample with a gentamicin test request was followed from receipt into the laboratory to the issuing of the final report. This audit has a narrow scope as only one sample is being audited. This minimises the probability of quality issues being identified by the auditor. This would lead to difficulties in determining if one sample is truly representative of errors and non – conformances occurring during the processing of patient samples. To widen the scope, it would be suitable to audit a larger number of patient samples such as 5 over a broader time period such as two months. This would outline more clearly any errors and non – conformances occurring during sample processing. The resolution of this sample issue will widen the scope of this audit.

Another flaw of this audit scope is that it does not outline when this vertical audit was last performed and how often it should be carried out. This information is important as it will ensure that audits are not being performed on the same processes too regularly.

Apart from these two issues, the scope of this audit was very informative. The document name, location and revision number were clearly visible on the audit form. This is essential for the correct control of laboratory documents and retrieval of these documents from Q – Pulse for future review. The auditor names, date the audit was performed, and the specimen number were also clearly visible on the audit form. I believe that the scope of this audit is in compliance with the standards outlined in ISO 15189.

Audit Checklist

This audit was performed in accordance with ISO standards. This was clearly outlined in the column labelled ‘ISO REQ’. The inclusion of this on the audit form was very helpful as the reader was able to easily access the section of the ISO standard that the individual questions were referring to. The ‘audit area’ was very well laid out and quite thorough. The questions posed to the auditor were clearly divided into the different sections such as ‘specimen collection’, ‘calibration & quality control’ and ‘reagents’. These questions followed the patient sample from collection to issuing of the final report. The audit form has also asked questions that are not included in the ISO standard. An example of such a question is ‘Do local rules on minimum data set comply with national guidelines on sample labelling?’.

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Regarding the audit checklist, it seems to be missing two key sections of the technical requirements outlined in ISO 15189. These sections are ‘laboratory information management’ and ‘personnel’. It is unclear as to whether staff have the required qualifications. It is very important to ensure that all laboratory staff are competent in performing the procedures regarding all aspects of gentamicin testing.

The column “records/methods checked/procedures witnessed” provides the reader with specific links to both the relevant SOP’s (standard operating procedures) and the relevant sections of the laboratory user manual. This is a very important part of the audit checklist and it is crucial to the auditing process. The inclusion of this information on the auditing form greatly improves the standard of the audit being performed as it provides the reader with information on the location of the required documents.

I found the ‘compliant?’ column to be very vague as the auditor only provided a one – word answer (yes or no).  I found this to be very unsatisfactory as much more details should be provided when performing an audit in a medical laboratory. Also, if this audit found non – conformances in the laboratory processes, the audit form does not have a section for these issues to be recorded. One such improvement would be to include a section on this form to record any recommendations and non – conformances. Another such improvement would be to expand the ‘compliant?’ section of the form to allow for more detailed answers.

This audit does not seem to have a review section. A review section is important because when the audit is repeated, it is important to check whether the non – conformances and recommendations that were previously raised have been dealt with and closed.

Audit Findings

The findings of this audit seemed to vary throughout the different sections of the document.  The sections titled ‘request form’ and ‘information for users and patients’ were very detailed and well presented. They provided the reader with detailed findings for these sections of the audit. However, some other sections of this audit were less impressive.

For some questions asked, the auditor responded with an answer of ‘N/A’. For example, ‘If this is a test where information for patients is required e.g. for sample collection, is this readily available to patients/users and appropriate?’ This question may not have been relevant to the sample being audited but some form of feedback for the reader would still have been useful.

On most occasions, this audit provides the relevant information and cross – referencing with regards to SOP’s and the laboratory user manual. However, one such occasion when this does not occur is associated with the ‘specimen transportation’ section of the audit form. The question ‘Are these procedures readily available where required?’ is asked and the auditor responds with the answer ‘Yes, the procedure above is available on Q-Pulse & Trust Intranet’. Personally, I find this answer to be unacceptable as there should be a link provided to the relevant SOP where this information can be found.

This audit highlighted some improvements that can be implemented within the clinical biochemistry laboratory in question. One such improvement can be found in the ‘request form’ section of the audit form. This audit highlighted that the template for the specimen request form is not a controlled document (not on Q – Pulse). This document should be uploaded onto Q – Pulse and controlled.

Another improvement that can be implemented is associated with the ‘specimen referral’ section of the audit form. The question ‘How does the laboratory ensure the suitability of its referral centres?’ was asked to which the answer ‘We review our referral laboratories on a 2 – yearly basis. The review includes checking accreditation, turnaround times & EQA performance’ was given. I believe that the frequency of every 2 years for referral laboratory reviewal is inadequate and should be increased to at least once a year.

The audit also highlighted a potential non – conformance with regards to the ‘calibration and quality control’ section of the audit form. The question ‘Does IQC have acceptance criteria and is IQC data regularly monitored?’ was asked to which an answer of ‘Yes, the values are set based on the QC procedure. Unfortunately, monitoring was not performed and was last due on the 11.11.2017’. In my opinion, these findings are unacceptable and are a cause for concern. Patient testing should not commence until all IQC procedures have been performed correctly. The auditor does not seem to have responded correctly to this question. The auditor stated ‘yes’ in the ‘compliant?’ section of the audit form. This is a potential non – conformance that needs to be highlighted by the auditor. The ‘calibration and quality control’ section of the audit form contained another badly answered question by the auditor. The question ‘Is EQA performance satisfactory for this examination?’ was asked to which an answer of ‘Yes, the last 6 distributions have been satisfactory’ was given. In my opinion, this answer was unacceptable as EQA performance before these last 6 distributions may have been inadequate. The auditor should have checked all EQA testing distributions for the test being audited (gentamicin).

Conclusion

In order to continually meet internal standards, medical laboratories perform internal audits to highlight potential non – conformances and recommendations associated with their processes. These audits help with the continued maintenance and improvement in the quality procedures of the medical laboratory. The competency of the auditor and the correct design of the audit plays a key role.

After critically evaluating this internal vertical audit, the auditor provided detailed answers to many of the questions on the audit form. However, some potential non – conformances and recommendations were highlighted. 

Therefore, this assignment has highlighted the importance of a well – designed audit and competent auditor to correctly evaluate the internal processes of a medical testing laboratory.

Word Count: 1786

References

• Hammar, M. (2018). ISO 9001: Horizontal audit vs. vertical audit, what is different? [online] 9001Academy. Available at: https://advisera.com/9001academy/blog/2015/03/03/iso-9001-horizontal-audit-vs-vertical-audit/ [Accessed 19 Nov. 2018].
• Goetsch, D. and Davis, S. (2013). Quality Management for Organizational Excellence Pearson New International Edition. 7th ed.
• INAB. (2018). Home – INAB. [online] Available at: https://www.inab.ie/ [Accessed 19 Nov. 2018].
• Iia.org.uk. (2018). What is internal audit? | About us | IIA. [online] Available at: https://www.iia.org.uk/about-us/what-is-internal-audit/ [Accessed 19 Nov. 2018].
• ISO. (2018). ISO 15189:2012. [online] Available at: https://www.iso.org/standard/56115.html [Accessed 19 Nov. 2018].