Upload
others
View
4
Download
0
Embed Size (px)
Citation preview
Implications of Update to ISO 15189:2012 –
A Laboratory Perspective
Brian Kelleher,
Quality Manager,
Laboratory,
St. James’s Hospital.
3 Different Scenarios
� Never before accredited
� Previously accredited by CPA
� Accredited under ISO 15189:2007
CPA → INAB: The SJH choices
CPA accreditation was per department.
� Apply to INAB by department
� Group some departments together under one application
� One application for entire laboratory (except BT) / extend BT scope
St. James’s Hospital Department of Laboratory Medicine
� Biochemistry (incl.POCT)
� Haematology (incl. Coagulation)
� Histopathology (incl. Cytology)
� Microbiology (incl. IMRL)
� Immunology
� NMRSARL
� CMD
� Blood Transfusion (ISO 15189:2007)
St. James’s Hospital Department of Laboratory Medicine
� Total Staff ~ 300
Clinical,
Scientific,
Nursing / Phlebotomy,
Clerical & MLA
� Workload ~ 8 million tests / annum
St. James’s Hospital Department of Laboratory Medicine
Quality Management System
Document System contains:
~ 1,100 Method / Procedure SOPs
~ 2,000 Forms
Several thousand other assorted documents.
~ 1,500 Assets (Equipment)
~ 1,150 Audits in 2014
~ 2,000 Non-conformances in 2013
CPA → INAB: The Challenges
� Compliance with new standards
� Integration of the QMS across different
departments:
Audits
Non-conformances
Audits
� Emphasis on vertical and ISO horizontal
� ISO horizontal scheduled for same month in each department
� ARG meets monthly to review
� One month later - 1 LabMed audit
ISO 15189:2007 → ISO 15189:2012
� INAB Document on website listing
changes (not comprehensive)
� Submission of transition plan
� Inspection against new standard
2007 → 2012
Do we eliminate anything?
� 4.15.2 reports from managerial and supervisory personnel
� 5.8.4 vocabulary and syntax of reports as per one of 11 listed organisations
v
� 5.8.3 i examination results reported in SI units, units traceable to SI units etc
ISO 15189:2012 – What’s New?
� 4.1.2.6 Communication (cf 4.1.6)
Records of communication / meetings with staff and users
� 4.14.4 Staff suggestions
Formal process for recording, review and implementation
� 4.14.8 Reviews by external bodies
ISO 15189:2012 – What’s New?
� 5.1.6 Competence (cf 5.1.11)
Competence to perform both technical and managerial tasks to be assessed
� “Managerial Tasks” not defined
� Assume to be non-technical
� CMS, SMS, IT Application Controller, H&S, T&E and Quality coordinators
ISO 15189:2012 – What’s New?
� 5.1.7 Reviews of Staff Performance
� Separate sub-clause to those dealing with training, competency, continuing education and professional development
� Reviews should consider the needs of the laboratory and the individual
ISO 15189:2012 – What’s New?
� 5.5.1.2 Verification v 5.5.1.3 Validation
Points to note:
� CE Marking & IVD directive
� Adaptation of CE products
� In house procedures / methods
ISO 15189:2012 – What’s New?
5.9.2 Automated selection and reporting of results – 6 requirements including:
� Definition of criteria
� Validation & approval
� ID of automatic authorisation
� Inclusion of relevant comment / warnings
� Rapid suspension when problems arise
ISO 15189:2012 – What’s New?
5.10 Laboratory Information Management
(Replaces Appendix B)
Includes:
� Authorities & Responsibilities
� Management of IT systems
� Validation
� Records of Changes (incl. updates)
ISO 15189:2012 – What’s New?
Two Major Changes
4.2.1 Laboratory Processes
and
4.14.6 Risk Management of Processes
ISO 15189 2012 Clause 4.2.1
� Determine the processes
� Determine the sequence and interaction
� Determine criteria for operation and control
� Ensure the availability of resources
� Monitor and evaluate the processes
� Implement actions to improve processes
A Process Approach
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.
ISO 9001 section 0.2
Step 1. Define Processes
Key processes
� Pre-examination processes
� Examination processes
� Post-examination processes
Support Processes
Everything else!!
Representing Processes (Sequence and Interaction)
� Flow Chart
� Process Diagram
� Table
� Sequential List
� Combination(s) of the above
INPUTS
Pre-examination
Processes
Examination
Processes
Post-examination
Processes
OUTPUTS
Management and
QMS Processes
User Requirements
User Satisfaction
Processes & Sub-processesOrdering of Investigations
Patient Identification
Patient preparation
Specimen Collection & Labelling
Specimen Transport
Specimen Reception
Specimen Preparation for Analysis
Processes & Sub-processes
Specimen Collection & Labelling
Assembly of Phlebotomy Materials
Phlebotomy Procedure
Labelling of Specimens
Correct Type(s) of Bottles
Correct Number of Bottles
Blood Collection Set
Gloves, swabs etc
Tube Order of Draw
Phlebotomy Technique
Barcode Labels
Handwritten Specimen Tubes
ISO 15189 2012 Clause 4.14.6
Risk Management
“The laboratory shall evaluate the impact of work processes and potential failures on examination results as they affect patient safety, and shall modify processes to reduce or eliminate the identified risks and document decisions and actions taken”
Risk Management Steps
1. List the processes
2. List the sub-processes
3. Identify the risks
4. Identify the existing controls (if any)
5. Apply a Risk Rating
6. Prioritise processes with highest risk rating
Risk Management
Standard HSE Approach (5 x 5)
Risk Rating = Severity x Likelihood
Severity
1 = Insignificant
2 = Minor
3 = Moderate
4 = Major
5 = Extreme
Likelihood
1 = Rare / Remote
2 = Unlikely
3 = Possible
4 = Likely
5 = Almost Certain
Risk Rating Matrix
Addressing High-Risk Processes
Reduce the Risk Rating by:
� Process re-design / amendment
� Implement Additional Controls
� Assign responsibility
� Assign a target completion date
� Revisit RA to ensure lowered Risk Rating
FMEA Approach
Failure Modes & Effects Analysis (FMEA)
Failure Mode – any error or failure in the process, either actual or potential, that can affect the final result of the process
Effects Analysis – studying the consequences of the errors or failures
FMEA for Processes
Questions
� Where are the critical control points where errors can occur?
� What is the likely occurrence of the errors?
� What are the likely severity and consequences of the errors?
� What is the priority for addressing the errors?
FMEA Approach to Risk Rating
Looks at:
� Severity
� Likelihood (of occurrence of error)
� Detectability (likelihood of detection)
(1 = certain to detect, 5 = never detected)
Uses a 5 x 5 x 5 system to calculate the Risk Priority Number (RPN)
ACSLM Workshop
� Held September 6th 2014
� Attended by 14 Quality leads / managers
� Delivered by Padraig Kelly (RCSI)
� Looked at Process Mapping
� Elimination of waste from process streams
� Looked at Risk Management (FMEA)
ACSLM Workshop
Suggestions
� A consistent approach country-wide to 4.2.1 & 4.14.6 would be best
� Consider developing a “library” of process map templates
� Agree a consistent system of risk assessment and rating
Library of Templates?
Examination processes:
Routine specimen flow
Urgent specimen flow
Out of hours specimen flow
or
Process flows for different analysers
or
Process flows for individual analyses
Library of Templates?
Post-examination processes:
Electronic reports
Hard-copy reports
Telephoned reports
Amended reports
Reports referred for clinical follow-up
??Support processes
Resource-related (5.1 – 5.3 & 5.10)
Personnel – e.g. training & competency
Real estate – e.g. environmental monitoring
Equipment – e.g. calibration & maintenance
IT systems – e.g. backup & contingency
??Support processes
Management Processes
Roles & Responsibilities
Communication
Management of Non-conformances
Change Control
Document Control
In the meantime!!!
Laboratories are being inspected by INAB so
� Identify processes / sequence / interaction
� Drill down as far as is practical in your lab
� Identify the risks and existing controls
(use a standard Risk Rating form / template)
� Identify the greatest risks
� Implement additional control measures