What is a Quality Management System? (QMS)
- A system of organisational structures, procedures, responsibilities, and evaluation mechanisms which ensures the organisation is capable of delivering its service to specific standards.
- A QMS is the total sum of all the processes that allow us to control the whole operation. The includes the documented set of policies and procedures which define how you achieve a defined quality of services and should address all the requirements of a specific standard.
- An assigned Quality Manager in the laboratory is responsible for ensuring the QMS functions properly, however the head of department has overall responsibility for the QMS.
What are the benefits of a QMS?
- Improve and monitor the effectiveness of laboratory performance
- To achieve better control of the processes
- Safeguard the organisation, patients and staff.
- Patients/service users: ensures good quality service which meets the requirements
- Management: ensures the lab is efficiently organised and managed in a way which meets the service users needs.
- Staff: Provides a framework which ensures good quality service is provided.
- Standardisation: Ensures all labs work to the same standard
- To achieve accreditation
What is the purpose of a quality manual?
The quality manual sets out the quality policy. It describes the QMS and outlines how the organisation seeks to comply with relevant standards. i.e. with ISO, giving reference to appropriate documents. It outlines a commitment to good scientific practice, health and safety and to comply with environmental legislation.
What is quality assurance?
Quality assurance comprises of all the different measures taken to to ensure the reliability of investigation and is not limited to the technical procedures carried out in the lab. Quality assurance is about getting it right first time i.e. preventing faults occurring consistently and by keeping all steps in the process under control.
What is involved with internal quality control?
This is the analysis of material of known content in order to determine in real time if the procedures are performing to the predetermined specifications. Good quality control is designed to prevent any faulty test results being reported but does not stop them occurring in the first place.
What happens when corrective action occurs?
Corrective action is taken to eliminate the cause of a detected non-conformity. This can be remedial action (fix at time) or can be a process including a root cause analysis (why it went wrong) after the fact.
What happens when preventative action occurs?
Preventative action is undertaken to eliminate the possible cause of a non-conformity before it happens. The first is a risk assessment followed by continual improvement.
How does a QMS provide a mechanism for quality improvement?
- Internal Audits (Detection of non-conformance and quality improvements recommended)
- Key Quality Objectives (Set annually, provides objectives for the lab to reach in order to improve service)
- User surveys (find out how users perceive the service and any improvements they would make)
- Error logs / Incident reporting (Analyse errors and suggest how they can be avoided in future)
- Complaints policy (Accept constructive criticism from users to improve service)
- Document reviews
- Staff appraisal / Identification of training needs.
What does ISO stand for?
International Organisation for Standardisation (ISO)
What are the main ISO standards which applies to medical laboratories?
ISO 15189 (2012) emphasizes the quality of contributions to patient care, as well as that of laboratory and management procedures, and is the preferred standard for genetic testing laboratories.
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. It can be used by medical laboratories to develop their quality management systems and assess their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
ISO 15190 specifies requirements for safe practices in the medical laboratory.
What is the role of external quality agencies?
- Independent external assessment confirms the laboratory meets specific requirements
- Assessed against international and nationally recognised standards demonstrating competence and performance capability.
What is the United Kingdom Accreditation Service (UKAS)?
The United Kingdom Accreditation Service is the sole national accreditation body recognised by
Government to assess, against internationally agreed standards, organisations that provide certification, testing, inspection and calibration services.”
What service does the UKNEQAS (United Kingdom National External Quality Assessment Service) consortium provide?
UKNEQAS provides external quality assessment schemes (EQAs) and proficiency testing across all clinical laboratories.
They provide access to online materials such as images for analysis and case scenarios for reporting, invite labs to submit previously reported cases online or send out wet samples for some EQAs.
Laboratories’ submissions are assessed by a panel of expert assessors.
The UKNEQAS member relevant to genomics is GenQA.
What is GenQA?
GenQA (Genomics Quality Assessment) is the UK NEQAS service for both molecular genetics and cytogenetics. It was formed 1st Jan 2018 by amalgamation of UKNEQAS (molecular genetics) and CEQAS (cytogenetics).
It provides external quality assessment schemes to laboartories to test:
- analytical & interpretive skills
- quality of results
- accuracy of reports
It provides an online training suite for Genetic Technologists (GTACT) and other competences for clinical genetics.
-
Patient Centred Care5
-
Communication5
-
Guidance & Laws7
-
Reflective Practice5
-
Clinical1
-
Research & Innovation2
-
Leadership18
-
Information Governance11
-
Good Scientific Practice4
-
Audit8
-
OSFA Station Ideas4
-
Health & Safety10
-
Quality14
-
Stats13
-
Clinical Governance6
-
Ethical Conduct7
-
Complaints5
-
Incidental Findings10
