Auditing Flashcards
What is an internal audit
A documented quality improvement exercise in which evidence is gathered systematically and independently, and evaluated to determine whether audit criteria are fulfilled for example;
1. compliance with lab policies and procedures,
2. compliance with external standards
Auditing identifies areas of non-conformities and improvement and measures the efficacy of the QMS
Giving users and the lab confidence in the system and provides evidence of due diligence
What is a clinical audit
Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through a peer-led systematic review of care against explicit criteria i.e. evidence-based standards
What is the purpose of auditing and how the effectiveness measured?
To improve practice; re-auditing may be required to confirm that improvements to practice have taken place
What are the main stages of an auditing process?
- Selecting a relevant topic
- Agree the standards of best practice i.e., audit criteria
- Collect data on current practice
- Analyse the data against the standards and feedback results
- Implement change if needed
What elements make up the Quality Management System in a Genetic Testing Laboratory
Management organisation Documents Continual improvement and quality assurance Test processes Resources External services
What is the consequences of failing to perform audits?
A drop in standards of pratice may lead to errors affecting patient care
The lab could get sued
Lose accreditation status
Lose business and funding
What are the auditing standards?
ISO15189:2012 Standards
25 main standards and 98 sub-category standards
What categories of audit exist?
First party – those you do internally to inspect own system
Second party - inspect a (potential) supplier for satisfaction with their system to provide products or services
Third party – carried out by an independent external auditor (e.g. UKAS) working for an accredited body to determine compliance to standards
What types of internal audits are there?
Vertical
Examination/witness
Horizontal
What is a vertical audit?
Examines all stages of a process and all of the variables that may affect any aspect of processes. Gives an overview of how the system works as a whole.
All aspects are checked in the samples pathway
i.e., user info, request form, transport,
sample storage, disposal,
specimen reception, SOPs, equipment,
IQC, EQA, staff training, reporting, authorisation, TATs
What is an examination or witness audit?
Examines the person undertaking the task to ensure whether the SOP is fit for purpose, is the individual trained (CPD records), has the process been validated
What is a horizontal audit
Examines one element in a process on more than one item .e., one specific standard is looked at in detail
What requirements does a SOP need to fulfill
ISO 15189:2012 requirements
What qualities make a good auditor?
Members of staff from an independent area of work provide a fresh pair of eyes
Auditors should be fair, ethical and honest
Conduct an audit within a no-blame educational culture
Evidence-based approach, recording evidence
What are examples of audit non-conformities?
Documents:
The SOP was not reviewed on scheduled date
An unauthorised copy of an authorised SOP was found
The copy of the SOP being used in the lab is an old version
Staffing
A staff member does not have a competency form adequately completed
A staff member has not had an appraisal in the last year
What is a reactive audit?
carried out in response to trend analysis, incidents or a change that requires audit
Who are responsible for overseeing national clinical audits?
Health Quality Improvement Partnership (HQIP) and the National Clinical Audit Advisory Group (NCAAG)
What is the role of the clinical audit facilitator
They assists with the project design and the project proposal paperwork, provide support and advice throughout the clinical audit process, e.g. sample selection, data analysis, presentation writing.
What is the role of the Clinical Audit Convenor?
They promote clinical audits, approve all projects, agree the audit programme and support the Clinical Audit Facilitator.
What is the purpose of The Clinical Audit Central Office
Produces activity reports including the Clinical Audit Annual Report, coordinates trust-wide and interface audit, organises the trust-wide training and recruits to and supports the Clinical Audit Team.
What is the purpose of The Clinical Audit Committee
The Clinical Audit Committee provides assurance of the clinical audit programme and provides a forum for the Convenors to discuss any issues they are experiencing
How is approval gained for a clinical audit
Clinical Audits must be registered with and approved by the Clinical Audit Team.
By approving and registering a project as a clinical audit, the Trust is stating that the project fulfils the methodological criteria that allows for patient data to be accessed and analysed.
Clinical audits do not require approval from the Research Ethics Committee (REC)
How can patient involvement benefit a clinical audit
Highlighting how the service can better focus on their needs.
Give insight into patient preferences and indicators of care quality
Give patients feelings of satisfaction after having influenced their care and from being listened to.
What is the lowest level of patient involvement with a clinical audit
Informing patients of the results of a clinical audit. A summary can be provided via newsletters, leaflets or via posters outlining the clinical audit topic, the background, aims, objectives and standards, results and any actions implemented.
What is considered a mid-level of involvement in clinical audit
Consulting the patient to determine whether standards have been met. Patient consultation in the clinical audit can be done via a focus group, patient survey, an interview, or the Patient, Advice & Liaison Service (PALS).
What is the highest level of patient involvement in clinical audit
Patient partnership in the clinical audit project from the very beginning, participating throughout the process
Patient partnership can be achieved by involving the patient on the clinical audit committee or project team and receiving direct input to identify and prioritise topics, designing projects, setting process standards and key outcomes, collecting data, analysing and interpreting results, disseminating findings and agreeing and monitoring action plans.
What types of information may be needed for auditing
Access to patient health records, reports with results, test requesting information
How are the results of an audit presented to peers
After completing an audit report, a clinical audit meeting can be held to deliver the results in a concise way, highlighting the most important findings of the audit
Why would an audit be carried out?
Reactive audits can be carried out in response to incidents or trend analysis showing a high level of PIRs in a particular area
Prospective audits are planned audits in line with the audit calendar
What are the requirements for a SOP?
These requirements are outlined in the ISO15189 standard and include mandatory headings for a SOP and a mandatory template we are required to comply with for UKAS
The SOP must contain a version number, active date, an owner and approver, the number of pages and page number
Purpose/Scope of the examination Principle of the method and procedure Performance characteristics: validation / verification / measurement of uncertainty Type of sample Required equipment and reagents Environmental and safety controls Procedural steps Quality Control procedures Laboratory clinical interpretation Potential sources of variation References
How often does a controlled document require review?
Every 2 years; this resets if a document is edited in the interim
