New CPA Standards and Audit

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New CPA Standards and Audit

• Dr Mansel Haeney
• 15 October 2003

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The new structure of CPA(UK)Ltd
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CPA Standards

• 43 standards, with guidelines
• 6 categories
• A Organization and administration
• B Staffing and direction
• C Facilities and equipment
• D Policies and procedures
• E Staff development and education
• F Evaluation

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Accreditation Process

• Self assessment
• Peer review inspection
• Detailed report
• Status
• Accreditation
• Conditional approval
• Referral

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Current Status
Referred
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Conditional
25
Accredited
69
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UK Laboratories

• Registered 1257 ( 85 )
• Yet to apply? 217 ( 15 )
• TOTAL 1474

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CPA status of all known departments
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New Standards For Old

• The new international standards
• ISO 15189 Quality management in the medical
  laboratory
• ISO 170252000 General requirements for the
• competence of testing and calibration
  laboratories
• ISO 90012000 series Quality management systems -
  requirements

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Problems with the old standards

• sections of standards had no logical relationship
• each standard had mushrooming guidelines
• the guidelines had uncertain status
• were open to misinterpretation.
• and led to lack of consistency in inspection

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Old CPA STANDARD
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Structure of new standards
Title of the standard
Explanatory text
Clause of the standard
Explanatory notes
Cross references
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Comparing the new with the old

• A Organisation and quality management system

• A Organisation and administration

• B Staffing and direction
• E Staff development and
  Education

• B Personnel

• C Facilities and Equipment

• C Premises and environment
• D Equipment, information systems and
  reagents

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Comparing the new with the old

• D Policies and procedures.

• E Pre-examination
• F Examination
• G Post-examination

• F Evaluation

• H Evaluation and quality assurance

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New concepts

• Section A, emphasis is placed on-
• a quality manual as an index to documentation
• laboratory management appointing a quality
  manager to implement and maintain a quality
  system
• a systematic approach to document control
• control of process/quality records and clinical
  material
• an annual management review to ensure that the
  service is at a level that meets the needs and
  requirements of users

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New concepts

• Sections B, C and D deals with resources
• largely familiar to CPA applicants
• Sections E, F and G deal with pre examination,
  examination and post examination processes -
• presents familiar material in a logical and
  structured format

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New concepts

• Section H deals with quality assurance and
  evaluation in terms of-
• monitoring both user satisfaction and complaints
• internal audit of the quality management system
• internal audit and external quality assessment of
  examinations
• importance of continual improvement processes

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Relationship between standards
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A quality management system .for a laboratory
needs to be..

• established
• controlled
• reviewed
• improvedcontinual improvement
• include the management of resources and
  examination processes

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Aspects of a quality management system
established
improved
A1 Organization and management A2 Needs
requirements of usersA3 Quality policyA4
Quality management system
H6 Quality improvement
H2 Assessment of user satisfaction
and complaintsH3 Internal
audit of quality management systemH4
Internal audit of examination
processesH5 External quality assessment

A 5 Quality objectives and plans A 6 Quality
manual A 7 Quality manager A 8 Document
controlA 9 Control of process quality
records
A10 Control of clinical material
A11 Management review
reviewed
controlled

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How to start with assessment(internal or
external audit)

• The assessment process involves finding
  information that enables the assessor to judge
  whether the laboratory is operating in
  compliance with the Standards.
• The findings need to be recorded
• CPA suggest the terms compliances,
  non-compliances or observations.

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What is a non-compliance?

• the failure to fulfil the requirements of a
  standard, in whole or in part.
• Assessors will record two categories of
  non-compliance
• Critical non-compliance and non-critical
  non-compliance
• Additionally assessors will record observations

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Critical non-compliance

• a failure to fulfil the requirements of a
  CPA Standard to such a degree that, in
• the opinion of the assessor, there is
• evidence of a system failure
• Normally, it is evidenced by the failure to
  comply with the whole of a CPA Standard and is a
  reason for referral.

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A system failureis evidenced by the inability of
a department to

• Meet the agreed needs and requirements of its
  users
• OR
• Ensure a safe environment for staff / patients or
  visitors
• OR
• Ensure the quality of all the laboratory
  examinations performed

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Auditing Tools

• Horizontal Audit
• Vertical Audit
• Examination or Witnessing Audit

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• A HORIZONTAL AUDIT focuses on the system for
  managing quality and assesses individual
  standards
• Interviewing the Quality Manager an important
  part of the process
• It involves a detailed check of a particular
  aspect of documentation and its implementation

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Section H the records to show that the system of
managing quality is working

• Records for example
• minutes of meetings
• annual management reviews
• user complaints and action taken
• staff annual joint reviews
• audit calendar
• internal audits
• health and safety audits
• non-conformities recorded
• participation in appropriate EQAS

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Section H the records to show that the system of
managing quality is not working

• Records for example
• minutes of meetings / cancelled meetings-minutes
  with no
  action points
• annual management reviews / none held
• user complaints action taken /remain
  undischarged
• staff annual joint reviews / behind schedule
• audit calendar / target dates missed
• internal audits / no records
• health and safety audits / untidy laboratory
• non-conformities recorded / not discharged
• participation in appropriate EQAS /results not
  discussed

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Vertical and examination audit
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CPA Examinationaudit form Page 1/2
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CPAExaminationaudit form Page 2/2
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Selecting the Request for Audit
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Request Form Searching
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The Request Form
Patient identification details
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Reprinting the Report
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Locating the Specimen
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Specimen Reception
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Checking Work Book Details
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The Analyser Relevant to Audit Request
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Instrument Maintenance Record
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EQA Performance
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CPAVerticalauditform Page 1/10
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How was it for you?
How long did it take? Did you find it easy to
use? Any suggestions for improvement? Did it help
you evaluate your own laboratory?