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