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CPA (UK) Ltd Assessments Everything you wish you had known before the visit Alison Springall Regional Assessor 5 February 2009. CPA (UK) Ltd Assessments. 4 year cycle 2 year Surveillance visit. Number of Cytology Laboratories. Accredited = 93 Conditional Approval = 56 Referred = 22.

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CPA (UK) Ltd AssessmentsEverything you wish you had known before the visitAlison Springall Regional Assessor5 February 2009
cpa uk ltd assessments
CPA (UK) Ltd Assessments
  • 4 year cycle
  • 2 year Surveillance visit
number of cytology laboratories
Number of Cytology Laboratories
  • Accredited = 93
  • Conditional Approval = 56
  • Referred = 22
reasons for referral
Reasons for referral
  • Refused visit
  • Conditions not met
  • Timescales for critical non compliances expired
process for main assessment visit
Process for main assessment visit
  • Regional Assessor will contact lab to arrange dates
  • Timetable and required documentation sent in advance
  • Visit with peer assessors
  • Support during and after the visit
  • Feedback to CPA on the experience
  • All laboratories have had a main assessment visit
process for surveillance visit
Process for surveillance visit
  • Regional Assessor will contact laboratories
  • Surveillance visit will take place within 2 years of main assessment
  • 1 day assessment
  • Regional Assessor will be on their own
  • May be occasions when peer assessor may also attend
surveillance visit
Surveillance Visit
  • On going compliance with CPA Standards
  • Check progress with any outstanding non compliances from main assessment
  • May be accompanied by peer assessor
  • Continuing support for laboratories
revised standards
Revised standards
  • Version 2 (Sept 2007)
  • In place since September 2007
  • Launched at conference April 2008
  • Assessed against this standard since April 2008
  • Will now affect the status of laboratories
revised standards main findings
Revised standards – main findings

A3.1a Quality Policy – scope of the service

A6.2 d Quality Manual – roles and responsibilities of laboratory management, including the Quality Manager

revised standards main findings11
Revised standards – main findings
  • A11 Annual Management Review
  • Annual Registration form includes the template for the executive summary
  • Includes all the items that should be discussed at the Annual Management Review
  • Quality Policy and Quality Objectives are reviewed
revised standards main findings12
Revised standards – main findings
  • B1 – Laboratory Director
  • Duties of Laboratory Director should be documented
  • Delegated duties and responsibilities documented
revised standards main findings13
Revised standards – main findings
  • B2.2 Registration of staff
  • Regular checks that staff are registered
  • Include in the schedule for audit
revised standards main findings14
Revised standards – main findings
  • B5.1f Job descriptions should include that staff participate in appraisal
revised standards main findings15
Revised standards – main findings
  • B9 Training and Education
  • Training programme for all staff- don’t forget MLA’s and clerical staff
  • Assessments of competency following training
  • Records of training and competency assessments
  • Include any problems and retraining
revised standards main findings16
Revised standards – main findings
  • D1.2 – procedure for procurement and management of equipment
  • Trust procedure may not cover all the requirements of the standard
  • Inventory of equipment – include the location of equipment
revised standards main findings17
Revised standards – main findings
  • E1.2 – Information for Users
  • Ensure that it includes all the requirements of the standard
  • Produce it in conjunction with the users
  • Where is it available?
  • They may not find 177 pages easy to use!
revised standards main findings18
Revised standards – main findings
  • H1.1 Evaluation and Improvement
  • Ensure that you have procedures for all of the standard
revised standards main findings19
Revised standards – main findings
  • H6 Quality Improvement
  • Establish Quality Indicators
  • Examination processes
  • Non examination processes
  • Determine methods and frequency of monitoring
revised standards main findings20
Revised standards – main findings
  • H7 – Identification and control of non conformities
  • Method of recording all non conformities ie. Internal errors and non conformities from audit
  • Regular review to detect trends
  • Corrective and preventive actions
revised standards main findings21
Revised standards – main findings
  • Procedure to be implemented in the rare event of wrong results being released
  • Stop analysis, recall results
  • Has an harm come to patients
  • Investigate, corrective & preventive actions
  • Authority for resuming the analysis
audit cycle
Audit Cycle
  • Plan – audit schedule, define scope of audit
  • Do – carry out audit
  • Check – against CPA standard, record findings, root cause, monitor corrective actions
  • Act – put improvements in place
  • Start cycle again
quality improvement
Quality Improvement
  • Remedial Action – quick fix
  • Corrective Action – will eliminate the root cause of non conformities
  • Preventive Action – will eliminate the causes of potential non conformities
  • Improvement – continual cycle
what qms audits are required
What QMS audits are required
  • Evaluation of Quality Policy
  • Needs and requirements of users
  • Staff are familiar with QM and all procedures relevant to their work
  • Good professional practice, training
  • Health and safety
  • Environmental
  • Compliance with CPA standards
needs and requirements of users
Needs and requirements of users
  • Evidence of regular meetings with users
  • Assessment of User satisfaction
  • Not only assessed by questionnaire
  • Record findings as with any other audit
  • Put improvements in place
staff are familiar with qm and all procedures relevant to their work
Staff are familiar with QM and all procedures relevant to their work
  • Evidence of induction
  • Vertical audits
  • Examination audits
good professional practice
Good professional practice
  • Training programme for all staff
  • Training records
  • Competency assessments
  • Evidence of CPD
  • Registration of staff
health safety
Health & Safety
  • Health and Safety audits
  • Evidence of good housekeeping
  • Equipment – PAT testing
slide29

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environmental
Environmental
  • Waste management audit
  • Equipment - maintenance
compliance with cpa standards
Compliance with CPA standards
  • Horizontal audit against CPA standards
  • Don’t have to do it all in one audit
  • Break it down into sections of the standard
what makes for a good assessment visit
What makes for a good assessment visit
  • Clear instructions
  • The same for every laboratory
  • Learned something new
  • An opportunity to comment on the experience
take home messages
Take home messages
  • Know the CPA “Standards for the Medical Laboratory”
  • Quality Management is not just a Managers responsibility
  • Say what you do and do what you say
  • If it isn’t documented then it hasn’t happened
take home messages34
Take home messages
  • Use and abuse your Regional assessor
  • Not just for the assessment visit
  • Consistent approach
  • Can’t do it for you
useful websites
Useful websites
  • www.cpa-uk.co.uk
  • www.hse.gov.uk/myth