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By: Kathy McCloy MT(ASCP)QA Director, AVP

Integrated Oncology & DianonLabCorp

Objectives Overview of ISO 15189 Why LabCorp chose to pursue ISO 15189 Things to consider before starting the journey How to get started with the ISO journey Some of the successes and challenges Lessons learned from our journey

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What Makes ISO 15189 Different?

Who is This New Guy in Town?

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What is ISO 15189?

International Organization for Standardization

for Medical Laboratories

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Why did LabCorp Pursue ISO 15189?

LabCorp provides leading-edge medical laboratory tests and services through a national network of primary clinical laboratories and specialized Centers of Excellence.

With scientific expertise in esoteric testing, genomics, and clinical and anatomic pathology, LabCorp performs more than 1 million tests on more than 370,000 specimens each day. LabCorp is a pioneer in applying advances in medicine and science to laboratory testing

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ISO 15189 Focuses On:Processes Prevention

Risk assessment

Understanding vulnerabilities

Apply effective measures – metrics

CAP 15189 is a highly-disciplined approach to implementing and sustaining change.

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LabCorp Accredited ISO Sites LabCorp, Tampa, Florida

11/19/2009 LabCorp , Center For Molecular Biology

12/2/2010 ViroMed Laboratories

1/27/2012 Accupath Diagnostic, Brentwood, TN

1/19/2012 Accupath Diagnostic, Irvine, CA3/1/2012Esoterix Genetic Laboratories Phoenix

9/17/2009 Esoterix Genetic Laboratories (Monrovia, CA)

4/15/2010 7

ISO 15189 Implementation(20 Step Process)

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Implementation Plan Strategy and Planning Identify implementation team Conduct readiness assessment Develop implementation plan Plan change management activities Conduct initial staff training Establish stakeholder commitment QMS Development Reassess market Set quality policy, objectives, and metrics Set preliminary goals for metrics Map and develop processes Identify needed support for processes Create documentation Assemble quality manual Enhance document control and records control Audit Conduct internal audit Perform root cause analysis and corrective action Conduct management review Provide audit phase training Maintenance Conduct internal surveillance audits

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STRATEGY AND PLANNING

1. Establish stakeholder commitment

2. Identify implementation team

3. Conduct readiness assessment

4. Develop implementation plan

5. Plan change management activities

6. Conduct initial staff training

QMS DEVELOPMENT

7. Reassess market

8. Set quality policy, objectives, and metrics

9. Enhance document control and records control

10. Provide training on process development

11. Set preliminary goals for metrics

12. Map and develop processes

13. Identify needed support for processes

14. Create documentation

15. Assemble quality manual

AUDIT

16. Provide audit phase training

17. Conduct Internal audit

18. Perform root cause analysis and corrective…

19. Conduct management review

MAINTENANCE

20. Conduct internal surveillance audits

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How We Started: With the management team and management buy in We stepped back and examined the “backbone”

processes of the organization. This included processes mapping … lots of process mapping.

Then the team looked for gaps in each process We engaged all the employees and broke out into focus

teams New processes were added and/or enhanced (e.g.,

internal audit, management review) that filled out the quality system in accordance with the ISO standard.

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How do the Assessors Audit?Intent (as reflected in policies, processes, and

procedures) Implementation (whether the intended system has

actually been implemented in terms of day-to-day operation of the lab) Effectiveness (producing consistent results while

catching & appropriately handling anomalies)

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What is their objective? To put responsibility for quality on management. While quality

requires the willing participation of laboratory staff, ultimately it is management's responsibility.

Establish focus on patient care. Insist on objectivity. Patient care must not be compromised by

conflicts of interest. Decisions by laboratory management must be free from any undue internal or external commercial, financial, or other pressures or influences that may affect the quality of the work.

Describe the overall structure of the QMS.

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ISO 15189 Requirements Management requirements• 4. I Organization and management• 4. 2 Quality management system• 4. 3 Document control• 4. 4 Review of contracts• 4. 5 Examination by referral laboratories• 4. 6 External services and supplies• 4. 7 Advisory services• 4. 8 Resolution of complaints• 4. 9 Identification and control of nonconformities• 4.I0 Corrective action• 4.I I Preventive action• 4.I2 Continual improvement• 4.I3 Quality and technical records• 4.I4 Internal audits• 4.I5 Management review

Technical requirements• 5.1 Personnel• 5.2 Accommodation & environmental conditions• 5.3 Laboratory equipment• 5.4 Pre-examination procedures• 5.5 Examination procedures• 5.6 Assuring the quality of examination procedures• 5.7 Post-examination process• 5.8 Reporting results

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4.1 - Organization and ManagementMake sure manager-level personnel contribute to qualityInternal (employees) and external (clients) communication

4.2 - Quality Management SystemThe cornerstone - “The Quality Manual”

4.10 - Corrective Action Root Cause and effectiveness checks

4.11 - Preventive ActionActions that have not yet occurred

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4.14 - Internal Audits All types of internal audits

“horizontal vertical, Focused, , Tracer, Laser Audit

4.15 - Management Review “snapshot” of its processes Assessors want to see that the organization is doing

something with the information it collects.

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“Comments”from the LabCorp sites that

have been though the ISO accreditation process and

lessons learned…

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Positives Impacts: ISO is a powerful and continual motivator, and it created a

different mindset for staff It gets the point across that quality is everyone’s

responsibility ISO requirements gave us a more balanced approach to

quality systems across our labs in a more global manner Looking at the big picture helped us to look at all levels and

not just one lab or one area

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More Positives Impacts: Increased Communication Standardized Processes Decreased turn-around-time Increased cost savings Don’t blame people, look at the process Have a solid back up plan It gave us tools to determine our focus as a facility Mainly “closing the loop”

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Not so Positives of ISO: The additional cost Management and Employees felt it was more work for them

at first Very time consuming to implement all of the processes and

training sessions correctly When there are serious errors, we can’t just change a

process and retrain staff, now we need to do true root cause analysis

ISO is time-consuming and sometimes it’s hard to picture the long-term benefits when the facility is swamped with so many other operational issues

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Favorite Comment: “I think staff generally perceives the ISO accreditation

as a true positive

But …it is important to realize the efforts do not stop at the point of accreditation. It will be a challenge for us to keep the focus on continued improvements and commitments to growth.”

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Lessons Learned: Don’t try to implement another organization’s “proven system”

– make it your own Don’t implement a QMS using the isolated categories of the

standards Involving staff in ISO is more of a challenge than one would

imagine Management involvement is a MUST Don’t just read the standards- understand how they will affect

your facility and employees

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You don’t have to have it “perfect” You are responsible for knowing what is done on a corporate

level from sales training, corporate services, updates, etc. It is not OK to say “they” do it.

Include staff in direct involvement in ISO decision making Last minute PowerPoint presentations and group review

sessions for staff have only limited value. These can even backfire (Inspector felt that staff had been “coached” to say “ISO is the International Organization for Standardization”)

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More Lessons: The “trickle down” approach (information filtered down

from management to staff) doesn’t work well ISO is something that can’t be taught; it needs to be

experienced. It was important to go through the optional Gap and pre-

assessment processes Make sure employees understand they will not be

punished if issues are uncovered (unless there are special circumstances, eg, flagrant dishonesty).

Clean the area before the ISO gap assessment

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Processes put in place (or improved) because of ISO: More robust Quality Management Databases –

CA, PA, CI, DC, Change Control, Process Mapping …

Performing a “true” Root Cause Analysis Management review meetings Process audits, Focus audits, QMS audits, and more

audits And then trending of those audits More robust document control system A great Quality Manual

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More Improvements: Supply Management Review The excitement and momentum generated with launching

new systems and training programs Fun activities Visuals so staff can relate to ISO Celebrating successes as a team Formed a committee to review department orientation for

new and transfer employees

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What would we do different? Use other labs lessons learned and help, but also make

this our own journey Spend more time having all staff understand what ISO

will do for them and the facility Needed to move processes along faster Get new systems up and running earlier Get everyone’s buy-in upfront

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QuestionsDo you need to have ISO 15189 to have a great quality

system? No, but it did help our LabCorp ISO accredited labs

Will all the LabCorp sites become ISO accredited Not at this time

Is ISO 15189 for everyone? No, you really need to evaluate the commitment and time

before pursuing

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The journey begins ………… Train all staff about Quality Management Systems and ISO

Establish the right quality policy and metrics

Enhance document and records control

Build skills such as “process mapping” and “root cause analysis”

Build a Quality Manual that works for the staff

Continue to communicate progress

Audit, audit and re-audit

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Accreditation and Beyond