Objectives 11/12/2012

Transcription

1 By: Kathy McCloy MT(ASCP) QA Director, AVP Integrated Oncology & Dianon LabCorp Objectives Overview of ISO Why LabCorp chose to pursue ISO 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 2 1

2 What Makes ISO Different? Who is This New Guy in Town? 3 What is ISO 15189? International Organization for Standardization for Medical Laboratories 4 2

3 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 5 ISO Focuses On: Processes Prevention Risk assessment Understanding vulnerabilities Apply effective measures metrics CAP is a highly-disciplined approach to implementing and sustaining change. 6 3

4 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, CA 3/1/2012 Esoterix Genetic Laboratories Phoenix 9/17/2009 Esoterix Genetic Laboratories (Monrovia, CA) 4/15/ ISO Implementation (20 Step Process) 8 4

5 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 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 10 5

6 11 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. 12 6

7 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) 13 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. 14 7

8 ISO 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 Organization and Management Make sure manager-level personnel contribute to quality Internal (employees) and external (clients) communication Quality Management System The cornerstone - The Quality Manual Corrective Action Root Cause and effectiveness checks Preventive Action Actions that have not yet occurred 16 8

9 Internal Audits All types of internal audits horizontal vertical, Focused,, Tracer, Laser Audit Management Review snapshot of its processes Assessors want to see that the organization is doing something with the information it collects. 17 Comments from the LabCorp sites that have been though the ISO accreditation process and lessons learned 18 9

10 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 19 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 20 10

11 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 21 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

12 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 23 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 ) 24 12

13 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 preassessment 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 25 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 26 13

14 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 27 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 28 14

15 Questions Do you need to have ISO 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 for everyone? No, you really need to evaluate the commitment and time before pursuing 29 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 30 15

16 Accreditation and Beyond 16