Quality in lab Flashcards
Terms etc (15 cards)
What do you do as part of your team to ensure good quality and practice?
• I have read all necessary Sops for tasks that I perform
• I have been trained by appropriate person
• I have had DOPs for various tasks and been signed off as competent to perform that task
• I perform tasks according to ACGS best practice guidelines, which ensure standardized methods of practice
• I have performed clinical audits in the past to ensure procedures are being carried out as they should
• I have logged errors through datix system so that any trends/patterns in errors can be recognized, the procedure ammened.
• I have taken part in EQA/NEQAS schemes, which aim to assesss labs and ensure laboratory test results are accurate, reliable and comparable.
• More individual/disease specific level:
o Ensure checks are performed, logsheet checks
o Ensure records are kept up to date (primer batch records etc)
o Troubleshooting and recording troubleshooting process
o Remain up to date with SOPs and changes to SOPs
o Changes to best practice
How do we ensure quality within the lab
- Our laboratory are accredited to ISO15189 by UKAS (this is a seal of approval that our laboratory and services have met the high standards set by UKAS)
- We have an online database called iPassport – stores all of our documents and quality materials
- SOPs – available for all processes and tasks in the laboratory to ensure everything is being performed to a standardised format
- All staff trained by competent member of staff
- Receive DOP / competency records
- All tasks are performed as per SOP / outline in BPG
- Each disease scientist / technical staff will keep batch records
- Equipment in the lab and processes/services have all been through validation/verification process and have met these standards
- Machinery is regularly serviced / maintained to ensure everything is working correctly
- Laboratory procedures are often observed at points where errors may occur (changing DNA from one tube to another)
- Worksheets are signed by individuals who have completed tasks in the lab
- We carry out regular audits to identify weaknesses in systems or processes
- We record errors on error-logging program (datix) – errors are reviewed
- Patterns in errors may indicate weakenesses in system/service, so these can be amended to prevent further errors.
- EQA (external quality assessment) Helps to improve test reliability by helping to minimise variability- looks at differences between sites testing the same thing (identification of identical specimens and comparison of results and reporting)
- Accreditation process (UKAS site visit to ensure our lab are performing up to standard)
What Documentation Would you find in Clinical Laboratories
- Standard Operating Procedures – ensure standard and comparable methods of practice for all staff who perform a task
- Accreditation documentation from UKAS
- Competency Paperwork for all staff performing task
- Maintenance/Service documents for machinery
- Validation and Verification paperwork for all procedures/equipment
What is Clinical Governance
Framework that ensures the NHS are constantly improving standards of patient care and safeguarding patient wellbeing, by establishing an environment in which excellence in healthcare can flourish.
• Audits (improve systems – lead to improved patient care
• Research (always aiming to identify best patient care available)
• Clinical Effectiveness (cost vs patient benefit enables best treatments to be selected which will benefit largest number of patients)
• Training (care is always up to date and current)
• Error Logging and Risk management (helps to prevent errors from reoccurring and enables improvements to systems which will improve patient care)
• Transparency (improves patient care by ensuring errors are out in the open so that they can be rectified /prevented
What is ISO 15189?
international standard that specifies the quality management system requirements particular to medical laboratories. UKAS provides accreditation to the internationally recognised standard ISO 15189 Medical Laboratories
What is CPA Accreditation?
CPA is a subsidiary of UKAS – but UKAS is currently aiming to transition all CPA accredited labs to UKAS accreditation (to the internationally recognised standard)
All Laboratories are due to be transitioned from CPA standards to ISO 15189:2012 by the end of March 2018. The implication of this is that it is no longer “the laboratory” which is accredited but tests that are included in the scope are now awarded accreditation. Laboratories and users are therefore encouraged to check referral laboratories to ensure that the tests requested are accredited. This can be done by checking the laboratory’s test repertoire as listed on their schedule of accreditation which can be viewed by searching medical laboratories within “UKAS Accredited Organisations” on the UKAS web site (www.ukas.com).
What are the standards of proficiency?
- Once registered, clinical scientists must continue to meet the standards of proficiency that are relevant to their scope of practice - the areas of their profession in which they have the knowledge and skills to practise safely and effectively. Continue to meet the standards of proficiency outlined by HCPC
- Recording CPD (how CPD activities improve the quality of work and benefit service users)
- Conferences – using ACMG guidelines, standardise variant interpretati
- Practise safely and effectively within their scope of practice
- Practise within the legal and ethical boundaries of their profession
- Maintain fitness to practise
- Autonomous professional, exercising their own professional judgement
- Awareness of impact of culture, equality and diversity on practice
- be able to practise in a non-discriminatory manner
- understand the importance of and be able to maintain confidentiality
- be able to communicate effectively
- be able to work appropriately with others
- be able to maintain records appropriately
- be able to reflect on and review practice
- be able to assure the quality of their practice
- understand the key concepts of the knowledge base relevant to their profession
- be able to draw on appropriate knowledge and skills to inform practice
- understand the need to establish and maintain a safe practice environment
Explain the purpose and set up of an EQA scheme
o EQA (External Quality Assessment)
o Looks at differences between testing sites for a particular test
o It is a yearly assessment to ensure:
o Clinical Laboratories are providing precise and accurate analysis to support optimal patient care
o Improves test reliability by helping to remove variability between labs (analytical variability, interpretive variability
o Provide structured questions and provide retrospective comparison of results and reports between labs
o Associated with a cumulative scoring system.
What information will be included in a change request form?
• Change is important in the lab
o Change can offer improvements to service delivery
o More efficient / time / workload / financial / accuracy
o Uncontrolled change introduces risk
o Everything in the laboratory is working under a validated and verified process
o Uncontrolled change poses risk that the process may then be working under a system / process that has not been validated or verified
o Planned changes that affect accredited processes must be communicated to UKAS as part of implementation process
o Change advisory Team
• Group of staff with knowledge and authority to manage change
• CAT review change suggestions, validation / verification documents
o Operational governance meeting
o Full senior management meeting – review changes in laboratory to provide visibility of changes across lab (identify accumulative impacts)
What is ACS (Association of Clinical Scientists)
o The objects of the Association are as follows:
o Assess trainees working towards registration with HCPC
o Work with official bodies including Health & Care Professions Council (HCPC) on matters relating to standards of qualification, training and competence.
o To liaise with relevant professional bodies to set standards for training and training centres to include availability of appropriate resources, regular assessment, pastoral care and mechanisms for addressing students training issues
What is the CQC (Care Quality Comission)
o The independent regulator of health and social care:
o We monitor, inspect and regulate services
o make sure they meet fundamental standards of quality and safety
o we publish what we find, including performance ratings to help people choose care.
HCPC (Health and Care Professions Council)
- a regulator set up to protect the public. To do this, we
- Keep a register of professionals who meet our standards for their professional skills, knowledge and behaviour.
- The people on our register are referred to as ‘registrants’
- Report any misdemeanours to HCPC
NICE (National Institute for Health and Care Excellence)
- Aims of NICE (non-departmental public body, independent of government):
- reduce variation in availability and quality of treatments
- Set national standards on how certain conditions should be treated
- Resolve uncertainty about which medicine and treatments work best / value for money for NHS
Purpose of accreditation?
- Accreditation is formal recognition by UKAS of competence to work and carry out the procedure to set of high standards set by UKAS – working within requirements of ISO15189 (international set of competency standards).
- Accreditation provides reassurance to service user of technical competence and integrity of the organisation’s services
- Not mandatory (but acts as a stamp of approval that the UKAS’ high standards for that process within the organisation have been met –
- therefore provides reassurance to service users that they can trust the quality of the service.
- UKAS can certify companies to award certification, but only UKAS can accredit.
- WMRGL 1st lab in UK to become accredited
What is Certification
Certification bodies (appointed by UKAS) provide written assurance from a third party that a procedure meets specified requirements (for us it is ISO 15189 – international set of standards for competence and quality in medical laboratories
