會計Essay模板：Auditing Process for Medical Testing Laboratory

本文是會計專業的Essay范例，題目是“Auditing Process for Medical Testing Laboratory（醫療檢測實驗室的審計程序）”，審核是質量管理體系的一個基本過程。審計使醫學實驗室的程序系統能夠被不斷地檢查。審計的執行醫療實驗室將確保“預審、審核post-examination和支持流程正在進行的方式滿足用戶的需求和需求”(ISO 2018)審核允許繼續維護和改進質量的醫學實驗室設置。

Introduction介紹

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

審計過程涉及兩個主要策略。這是橫向和縱向審計策略。醫學實驗室在進行審計時應該使用這兩種策略。垂直審計涉及檢查區域內質量體系的所有方面(Hammar, 2018)。醫學實驗室內部縱向審計的一個例子是，從病人樣本的采集到出具最終批準的報告。垂直審計對單個項目評估多個過程。橫向審計是指在組織的多個部門中對一個過程進行審計(Hammar, 2018)。醫學實驗室內部橫向審計的一個例子是檢查來自不同實驗室學科的患者報告，以確保它們都包含所需的信息

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.

這次審計是在一個臨床生物化學實驗室進行的，從收到一份要求進行慶大霉素檢測的病人樣本到提交最終報告為止。這次審核的范圍很窄，只審核了一個樣本。這將質量問題被審核員發現的可能性降到最低。這將導致在確定一個樣本是否真正代表在處理患者樣本時發生的錯誤和不符合時的困難。為了擴大范圍，它將適合審計更多的患者樣本，如5個更大的時間周期，如兩個月。這將更清楚地概述在樣品處理過程中發生的任何錯誤和不符合。這個示例問題的解決將擴大這次審計的范圍。

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審核檢查表

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?’.

這次審核是按照ISO標準進行的。這在標簽為“ISO REQ”的欄目中清楚地列出了。在審計表中列入這一點非常有幫助，因為讀者可以很容易地訪問個別問題所涉及的ISO標準部分。“審計領域”規劃得很好，也很徹底。向審核員提出的問題被清晰地劃分為不同的部分，如“標本采集”、“校準和質量控制”和“試劑”。這些問題跟隨患者樣本從收集到發布最終報告。審核表還提出了ISO標準中未包括的問題。這類問題的一個例子是“當地關于最小數據集的規定是否符合國家樣品標簽指南?”

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.

“記錄/檢查方法/見證程序”一欄為讀者提供了相關SOP(標準操作程序)和實驗室使用手冊相關章節的具體鏈接。這是審計清單中非常重要的一部分，對審計過程至關重要。在審計表單中包含這些信息可以大大提高審計的標準，因為它為讀者提供了所需文件的位置信息。

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審計發現

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.

這次審計的結果在文件的不同部分似乎各不相同。標題為“請求表格”和“用戶和患者信息”的部分非常詳細，呈現得很好。他們向讀者提供了審計這些部分的詳細發現。不過，這次審計的其他一些部分就不那么令人印象深刻了。

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.

在大多數情況下，這種審核會提供相關信息，并與SOP和實驗室用戶手冊進行交叉引用。然而，這種情況不會發生在審核表的“標本運輸”部分。問題是:“在需要的地方，這些程序是否隨時可用?”的問題，審計員回答說:“是的，上面的程序在Q-Pulse & Trust內部網上是可用的。”就我個人而言，我認為這個答案是不可接受的，因為應該提供相關SOP的鏈接，在那里可以找到這些信息。

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.

這次審計強調了可以在臨床生化實驗室實施的一些改進。這種改進可以在審核表單的“請求表單”部分找到。這次審核強調了樣品要求表單的模板不是受控文件(不是Q - Pulse)。此文件應上傳到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).

Conclusion結論

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.

為了持續符合內部標準，醫學實驗室進行內部審計，以突出與其流程相關的潛在不符合和建議。這些審計有助于繼續維持和改進醫療實驗室的質量程序。審核員的素質和正確的審計設計起著關鍵的作用。

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.

因此，這項任務強調了設計良好的審計和有能力的審計員對正確評價醫療檢測實驗室內部流程的重要性。

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