本文是会计专业的Essay范例，题目是“Auditing Process for Medical Testing Laboratory（医疗检测实验室的审计程序）”，审核是质量管理体系的一个基本过程。审计使医学实验室的程序系统能够被不断地检查。审计的执行医疗实验室将确保“预审、审核post-examination和支持流程正在进行的方式满足用户的需求和需求”(ISO 2018)审核允许继续维护和改进质量的医学实验室设置。
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.
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
审计过程涉及两个主要策略。这是横向和纵向审计策略。医学实验室在进行审计时应该使用这两种策略。垂直审计涉及检查区域内质量体系的所有方面(Hammar, 2018)。医学实验室内部纵向审计的一个例子是，从病人样本的采集到出具最终批准的报告。垂直审计对单个项目评估多个过程。横向审计是指在组织的多个部门中对一个过程进行审计(Hammar, 2018)。医学实验室内部横向审计的一个例子是检查来自不同实验室学科的患者报告，以确保它们都包含所需的信息
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:
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.
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?’.
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.
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.
在大多数情况下，这种审核会提供相关信息，并与SOP和实验室用户手册进行交叉引用。然而，这种情况不会发生在审核表的“标本运输”部分。问题是:“在需要的地方，这些程序是否随时可用?”的问题，审计员回答说:“是的，上面的程序在Q-Pulse & Trust内部网上是可用的。”就我个人而言，我认为这个答案是不可接受的，因为应该提供相关SOP的链接，在那里可以找到这些信息。
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.
这次审计强调了可以在临床生化实验室实施的一些改进。这种改进可以在审核表单的“请求表单”部分找到。这次审核强调了样品要求表单的模板不是受控文件(不是Q - Pulse)。此文件应上传到Q - Pulse并加以控制。
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).
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.
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