An audit is used to check and assure that the processes and methods used in a clinical laboratory comply with the required standards and to persistently improve the service provided for the service users.
The International Organization for Standardization – ISO9001 – defines an audit as “A systematic and independent examination whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives”.1
Audits are therefore an essential part of the Quality Management System and are a requirement by the Clinical Pathology Accreditation (CPA).
The aim of an audit is to collect information by means of observation, discussions and sampling to recognize areas where improvements can or needs to be made to improve the standards of the laboratory. An audit doesn’t only pick up on the poorer processes in the laboratory but also identifies those that are working well, giving an opportunity for the staff to learn from good practice and to allow there knowledge to be transferred to other processes.
Moreover, an audit allows organizations to assess their methods, determine any problems, and to produce cost effective and efficient solutions to fix them.
Audits are used to check practices against procedures and to carefully document any differences that may occur in detail. However, audits are only sampling exercises, so they cannot confirm that all aspects of a method are being obeyed with at all times.
There are 4 main types of audits:
1. Vertical Audit ...
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...o identify any problems in the Quality management system and make suggestions of any actions that need to be taken to improve the laboratory system.
An external audit is conducted by an outside person or organization, such as CPA and NHSGG&C Health and Safety officer (Biochemistry), MHRA and UKAS (Haematology) and the NHSGG&C Health and Safety Executive (Microbiology). These bodies want to ensure that the laboratories are following and conforming to the standards and to provide a safe and effective working environment.
An external horizontal audit is conducted by an external person on a specific element such as staff competency records.
On the other hand, a cooperative audit is carried out between the laboratory and another party of mutual benefit e.g. ward staff or clinic staff. These audits usually consist of clinical audits or user satisfaction questionnaires.
Auditors will assess the accuracy of inventory count and movement procedures. Auditors will also discuss any analytical procedures performed that are linked to inventory and talk about it with management about any substantial changes or strange developments in inventories.
The organisation must hire to meet the required standards, provide full training and determine the effectiveness of the training. The organisation must set up the needed facilities and maintain them for high class training. All personnel who affect the quality should be trained and qualified for specific
Objectivity also needs to be evaluated to make sure the internal audit is reliable. The internal audit needs to be free of conflicting responsibilities as well
A third party company will perform this audit that has no interest in the company to verify that they are operating in an ethical manner.
...et national criteria. The CQC and NHS require clinical governance and auditing to prove effective practice. In the absence of clinical audits it is very difficult to prove to the CQC and the NHS of whether you are practicing effectively which could affect your registration. Undertaking clinical audits within the practice to address current practice against national guidelines would have a number of benefits including identifying and promoting good practice which can lead to improvements in service delivery and provides information you need to demonstrate to the CQC that as a service provider you are delivering an effective service. It also provides opportunities for continued professional development through training and education and increases efficacy due to better utilisation of resources. Clinical audit is a multi-disciplinary activity and is an ongoing process.
Monitoring and evaluation are integral parts of management and provide a link between planning and implementation. While monitoring focuses on the activities and outputs, evaluation focuses on the outcome and goals. Monitoring focuses on inputs and outputs and is the continuous process of gathering information to measure against the goals and objectives. Evaluation, like monitoring, is a continuous process. Evaluation provides feedback on whether plans have been met and the reasons for success or failure. Evaluation should highlight shortcomings so they can be identified and corrected. It should provide direction for future plans. It is important to monitor and assess the on-going performance of teams and individuals, in order to evaluate the progress towards agreed objectives. Monitoring mostly involves keeping track of what is going on. By undertaking this regularly, we have the opportunity to make changes and adjustments, to ensure that any areas of concern are addressed.
A laboratory audit ensures that the laboratory has quality systems in place, follows good laboratory practices, and generates data of integrity and quality. If the laboratory standards have not been met changes are applied and then a re-audit is performed after a certain time period to ensure that the changes have been implemented and maintained. Stage 1 involves selecting a topic to be audited and is likely to include processes that have been shown to produce best outcomes for patients. Stage 2 is about defining the criteria and standards. The criteria defines what is being measured and the standards define the aspect of care to be measured and it should be based on the best evidence. Stage 3 is collecting of the data. To ensure that the collection of data is accurate, and that only vital information is collected, certain details of what is to be audited must be established from the outset and sample sizes of data should be of a reasonable size as this will allow you to come to a valid assumption. Stage 4 compares performance with criteria and standards. This stage analyzes the results obtained from the data collection and theses are then compared with criteria and standards. The end of the analysis concludes how well the standards were met and if any standards were not met improvements are likely. In stage 5 once the results have been discussed and published agreements must be made about the commendations for change. An action plan is good to record the ideas for change. Action plan development involves improvement of the audit mainly if measures are found to be incorrectly assessed. Also new process or outcome measures may be
List and briefly describe the elements of the 7 Component Framework Industry Standards for Auditing and Monitoring
There are common ethical dilemmas facing auditors today. The rules of conduct in Generally Accepted Auditing Standards (GAAS) and their application to the auditing process are paramount to auditors because it shows that an independent auditor plans, conducts, and reports the results of an audit in accordance with generally accepted auditing standards. Auditing standards provide a measure of audit quality and the objectives to be achieved in an audit. Auditing procedures differ from auditing standards. Auditing procedures are acts that the auditor performs during the course of an audit to comply with auditing standards.
Clinical Pathology Accreditation (CPA) is responsible for evaluating and accrediting medical laboratories in both the private and public sector. CPA is the primary accreditation organization and when a laboratory fulfils the standards which is required by the CPA that medical laboratory is acknowledged as a competent laboratory. Although becoming an accredited laboratory is voluntary most laboratories decide to become accredited because they need the laboratory to be recognized as a trustworthy lab. In 1992, the company merged with, the Association of Clinical Pathologists, Royal College of Pathologists, the Association for Clinical Biochemistry, the Institute of Biomedical Science and is a branch of United Kingdom Accreditation Services. CPA
The major characters of the tradition audit are all information what is needed by auditors are on the paper and the manual calculators and without high communication technology. Auditors usually were limited by the place in the paper time. When a several people are working on the same auditing project for a client with offices in cities across the country, even worldwide, it takes a lots all time those auditors get the information which they need from the client, even there is risk paper information disappear for many reasons. on the another hand, mail paper information increase the auditing cost. The mistake caused by the manual calculators inevitably, no matter how fixed auditors concentrate on recalculate is, after all auditors are human. The global business become major in the modern business world, some example, several auditors who are in different locations are working a same auditing project, or auditors are in different city even country with the client, when there is issue among these auditors or between auditors and client, they only can communicate with each other by phone or be together and have meeting. Phone call can not make sure information been watched in the same time when the voice is talking about the issue, but having a meeting takes time and money make all people together, it increases auditing cost.
Laboratory test results play a very important role in the diagnosis and treatment of a patient. The physicians and the other healthcare personnel are made
The fundamental duty of an external financial auditor is to form and express an opinion on whether the reporting entity’s financial statements are prepared in accordance with the relevant financial reporting framework. In discharging this duty, the auditor must exercise “reasonable skill, care and caution” (Lopes, J. in Kingston Cotton Mill Co 1896) as reflected in current legal and professional requirements.
The evolution of auditing is a complicated history that has always been changing through historical events. Auditing always changed to meet the needs of the business environment of that day. Auditing has been around since the beginning of human civilization, focusing mainly, at first, on finding efraud. As the United States grew, the business world grew, and auditing began to play more important roles. In the late 1800’s and early 1900’s, people began to invest money into large corporations. The Stock Market crash of 1929 and various scandals made auditors realize that their roles in society were very important. Scandals and stock market crashes made auditors aware of deficiencies in auditing, and the auditing community was always quick to fix those deficiencies. The auditors’ job became more difficult as the accounting principles changed, and became easier with the use of internal controls. These controls introduced the need for testing; not an in-depth detailed audit. Auditing jobs would have to change to meet the changing business world. The invention of computers impacted the auditors’ world by making their job at times easier and at times making their job more difficult. Finally, the auditors’ job of certifying and testing companies’ financial statements is the backbone of the business world.
It is known as ISO 9000 family and the ISO 9001 is the one which is concerned about the requirement of the QMS. Of course, that creates the needs for understanding these standards in order to get the certificate from the organization which is authorized by the ISO. That also creates the need for the training which is very important for companies to implement the QMS. The standards have been developed the course of the quality history from needing a quality control to a quality assurance. Basically, implementing a Quality Management System is important for companies to succeed in today’s market, and will enhance customer satisfaction, and improve internal process. It becomes more and more a necessity for international companies because it saves a lot of money in one hand and time in the other. Nevertheless, implementing such system requires an effort, training, and using consultant companies to ease the establishment of the system and to get the certificate eventually.