Ontario Laboratory Accreditation Peer Assessment Process Peer Assessment Visits: What to expect

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Ontario Laboratory AccreditationPeer Assessment
ProcessPeer Assessment Visits What to expect
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Purpose of a Peer Assessment

• To determine
• Conformance to OLA requirements (based on ISO
  15189, generally accepted principles of good
  practice and applicable legislation)
• Conformance to testing scope specified on licence
• To (ultimately) issue accreditation certificates

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The Value of Peer Assessment

• Ensure that laboratories meet mandatory quality
  management system criteria, in order to give
  formal recognition that the laboratory is
  competent to carry out examinations
• Assessment by peers ensures consideration is
  given to new technical developments, unique
  challenges

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Relationship between OLA and EQA

• OLA ensures that quality management processes
  are in place
• while
• EQA monitors if processes are effective (output)
• Continued OLA accreditation dependent on
  demonstration of ongoing competence in EQA
  surveys
• EQA (targeted) on-site consultations will
  continue

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Peer Assessments

• Scheduled once every five years
• Notification 120 days in advance of expected
  visit
• Mutually agreeable date set
• Assessment against essential requirements only
• May occur more frequently

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Important Notes

• Laboratory to identify a site coordinator who
  works with the OLA staff coordinator regarding
  visit arrangements
• A pre-assessment visit questionnaire and
  self-assessment of the quality manual (along with
  the quality manual) are requested before the
  visit

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The Peer Assessment Process

• Steps in a peer assessment
• Notification of laboratory
• Visit coordination and team assembly
• Confirmation of team and agenda
• Assembly of assessor packages
• On-site assessment visit (opening and summation
  meeting)
• Formal summary report
• Implementation and submission of corrective
  actions
• Review of corrective actions
• Certificate Issue

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Multi-Site Assessments

• Criteria
• Single management structure
• Single QMS
• Single assessment team
• Sites within reasonably close proximity
• Assessment(s) occur within a week

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Multi-Site Assessments

• To corporately-linked facilities conducted as a
  single visit
• One opening meeting
• Assess management and QMS only once
• Confirm selected issues at each site
• One summation meeting

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Assessor Binders

• Assessors receive the following information prior
  to visits
• Itinerary, travel details and applicable
  tickets/documents
• Team contact list
• Visit agenda
• Laboratory testing scope, staff list, equipment
  list
• EQA participation and performance information
• Results of prior self-assessment
• Completed pre-visit questionnaire
• Summary of quality manual review and quality
  manual
• Checklists
• Procedures
• Evaluation form
• Expense form

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Logistics of Arranging the Visit

• Priority To-dos
• Once the designated correspondent and official
  laboratory director are notified of upcoming peer
  assessment visit by mail and telephone, a
  laboratory site coordinator must be identified to
  work with the OLA staff coordinator.
• Laboratory management must ensure that all
  personnel are aware of the upcoming peer
  assessment visit.
• Laboratory management must ensure that all
  personnel are familiar with OLA requirements.

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Logistics of Arranging the Visit, cont.

• Once the designated correspondent and official
  laboratory director are notified of upcoming peer
  assessment visit by mail and telephone, a
  laboratory site coordinator must be identified to
  work with the OLA staff coordinator.
• Complete and return pre-visit questionnaire
• Complete QMS self-assessment and submit with
  Quality Manual
• Review and approve proposed agenda
• Facilitate team confirmation
• Book conference rooms, audiovisual equipment (if
  applicable)
• Arrange lunch for assessors
• Ensure appropriate staff are present for opening
  and summation meetings
• Provide lab coats and visitor badges (if
  applicable)
• Arrange for 10 minute interviews with two clients
  (e.g. physician, nurse)

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Logistics of Arranging the Visit, cont.

• Priority To-dos
• Laboratory management must ensure that all
  personnel are aware of the upcoming peer
  assessment visit.
• Notify key personnel in other departments, if
  applicable(e.g. safety officer, LIS specialist,
  materials management, engineering, human
  resources, POCT specialist)
• Review purpose of assessment

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Logistics of Arranging the Visit, cont.

• Priority To-Dos
• Laboratory management must ensure that all
  personnel are familiar with OLA requirements.
• Review OLA requirements
• Review what to look for discipline information
• Review list of documents and records for review
  during visit

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Opening Meeting With Facility Staff

• Team leader conducts
• Introductions
• Explains assessment process
• Confirms agenda, personnel and arrangements
• Explains evaluation feedback mechanism

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Assessment Gathering Information

• Three primary techniques
• Observation observe activities
• Interviewing asking questions using the
  checklist
• Reviewing documents and records
• Polices, processes, procedures
• Records
• Each assessor has his/her own style but all
  will use a combination of these techniques

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Practical Tips

• Preparation in advance is CRITICAL
• Be familiar with requirements and what to look
  for
• Be aware of what assessors might ask for
• Produce available evidence of conformance
• Assessors will share their findings, but may need
  to confirm with the team to determine if a
  non-conformance is major or minor (Post-it
  notes used by assessors do not necessarily mean
  non-conformances)

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Major Non-conformance

• Non-fulfillment of any requirement to a major
  degree
• Requirement not addressed by laboratorys quality
  manual or operating procedures
• Procedures are consistently NOT followed
• Existing protocols fail to address requirement
• Non-conformance directly impacts patient safety
• Consistent/persistent incidence of
  non-conformance
• Repeated incidence of non-conformance in the
  majority of sections of the laboratory

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Minor Non-Conformance

• Non-fulfillment of any requirement to a minor
  degree
• Isolated incident of non-conformance
• Adherence to procedures is inconsistent (usually
  followed but sometimes not)
• Existing protocols address requirement but are
  not necessarily followed

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The Numbers Game

• Certificates are NOT issued based on the number
  of non-conformances observed
• Certificates are issued based on your response in
  90 days (how non-conformances are addressed
  through corrective action)
• A single issue can generate more than one
  non-conformance

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Quick-Fixes on Site

• A laboratory may FIX a non-conformance while
  the team is present, at the discretion of the
  team leader provided that
• Document control is in place
• Approval is indicated on the new documentation
• New policy/process/procedure requires absolutely
  NO staff training, information or orientation
• Clear evidence of acceptable practice exists
• Sole motivation is not to reduce of
  non-conformances

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Conflict Resolution

• Encourage staff to provide evidence of
  conformance prior to the summation meeting
• When a disagreement occurs, team leader mediates
• There is a mechanism to submit an Errors of
  fact following the assessment
• - welcomed by QMP-LS within two weeks after
  receipt of printed summary report
• - not to be confused with a challenge to the text
  of a requirement

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Pre-Summation/Summation Meeting

• Lead by team leader
• All non-conformances conveyed
• Verbal summary ONLY
• Pre-summation meeting may occur with key staff
• Format of summation varies
• Dependent on the number and nature of
  non-conformances
• Preference of laboratory management
• Follow-up process explained

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Following the Visit

• Evaluation feedback to QMPLS
• Printed summary report issued within 30 days
• Errors of fact must be submitted within 10
  business days of receipt

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Following the Visit, continued

• Corrective action plan due within 90 days from
  visit
• Be specific, provide documentation
• Corrective action reviewed by OLA staff
  coordinator, team leader and Advisory Panel
• Further evidence or clarification may be requested

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Certificate Requirements

• Evidence provided that
• Majors corrected or suitably addressed
• Minors satisfactory action plan in place
• 5 year Accreditation
• If Majors cannot be corrected but satisfactory
  action plan is demonstrated
• 2 year certificate with opportunity to upgrade
  to a 5 year certificate when action plan completed

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Accreditation Certificates

• Specific to facility licence and identified scope
• Laboratory name and address specified
• Applicable scope of testing attached
• Formal recognition of competence in meeting ISO
  15189, generally accepted principles of good
  practice and applicable legislation
• Conditional upon satisfactory performance in EQA

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Summary

• Laboratories know prior to peer assessment visit
• When visit will occur
• Who assessors will be
• What will be assessed
• Laboratories are expected to
• Be prepared for visit
• Be familiar with requirements
• Provide evidence of conformance
• Submit any Errors of fact following visit
• Provide corrective action following receipt of
  printed summary report
• Documented evidence
• Detailed action plans