CAP 15189: ARUP s Journey. Jonathan Carr Director of Compliance, Quality, Privacy, and Risk ARUP Laboratories, Salt Lake City, Utah

Transcription

1 CAP 15189: ARUP s Journey Jonathan Carr Director of Compliance, Quality, Privacy, and Risk ARUP Laboratories, Salt Lake City, Utah May 2017

2 Outline Background: ARUP and ISO Motives Implementation Assessment Outcomes Lessons Learned

3 About ARUP Laboratories Nonprofit, academic affiliate 3,500+ employees including 90+ medical directors Provides testing for: genetics immunology oncology pediatrics pain management One of the broadest test menus 3,000+ tests and test combinations Clients include: university teaching hospitals children s hospitals multihospital groups commercial laboratories group purchasing organizations >10 million specimens/year >6.5 million patients affected/year

4 ARUP believes in collaborating, sharing knowledge, and contributing to laboratory medicine in ways that provide the best value for the patient it s why we exist; why we care; why we are an academic, nonprofit institution.

5 Background ISO ISO and CAP ISO is an International Standard that specifies requirements for competence and quality that are particular to medical laboratories. CAP is an accreditation program.

6 Background ISO Pages 5 Sections I. Scope II. Normative References III. Terms and Definitions IV. Management Requirements V. Technical Requirements

7 Background ISO CAP LAP CAP Mandatory Optional Unannounced inspections Announced assessments Peer inspectors Discipline-specific checklists Procedures and laboratory practice Professional assessors Less prescriptive ( basic concepts ) Systems improvement, risk mitigation

8 Motives

9 Motives Quality Market Regulations

10 Motives The Five Pillars of ARUP Culture I. Provide excellent patient care by supporting clients II. Create a good working environment III. Do the right thing IV. Improve continuously V. Act responsibly

11 Motives Strategic Priorities Innovation Differentiation Growth Efficiency Performance

12 Motives Constant Reminders Executives Quality Team Lab Management

13 Implementation

14 Implementation Gap Assessment August 2014 Quality Manager June 2015 Accreditation December 2016 Consultant April 2015 April 2016 Accreditation Assessment August 2016

15 Implementation Gap Teams Nonconformance Process Supplier Program Document Control Corrective and Preventive Action Training Internal Audits

16 Implementation Quality Reporting Structure CEO Director of Compliance, Quality, Privacy, and Risk Quality Manager Risk / Privacy Manager Patent Agent Quality Specialists

17 Implementation ISO Steering Committee Medical Directorship Technical Operations Finance Sales Purchasing Information Technology Human Resources Quality

18 Implementation Communication ISO Fair

19 Implementation Communication Lab walkthroughs ARUP intranet Presentations updates Videos CEO Quality Lab Posters

20 Implementation

21 Implementation

22 Implementation

23 Implementation Badge Buddy

24 Implementation Communication Small Group Discussions

25 Implementation Pre-accreditation self-assessment 4 months prior to accreditation assessment 15 assessors Interviews and audits Nonconformances and recommendations

26 Implementation Frequent contact with CAP assessment team Progress updates Assessment scheduling

27 Assessment

28 Assessment August 2016 Three CAP assessors Five days Daily summaries Assessors were impressed with Assessors are looking closely at Assessors are asking laboratory staff Scheduling updates

29 Outcomes

30 Outcomes Positive feedback Opportunities for improvement Major and minor nonconformances

31 Outcomes Management commitment CFO on ISO Steering Committee Staff familiar with Quality Policy Posters throughout the labs answering the why of ISO Staff members had a solid understanding of document control procedures, requirements and purpose

32 Outcomes Communication across laboratory disciplines Staff members utilized the CAP walkthrough course Machine shop/automation group Excellent workmanship

33 Outcomes Best in Class Empowered staff to recommend and implement improvements Staff sees the benefits of the ISO journey Standardization of processes Improved communication within department, between shifts, and other departments Looking more at the process and less at the individual Commitment to quality at all levels

34 Outcomes

35 Outcomes Given the test menu that ARUP offers, it is among the largest organizations to achieve ISO accredited status by the CAP. It s impressive that an organization with so many laboratories has been able to unify those sections with best practices and effective ways of sharing information. CAP Lead Assessor

36 Lessons Learned

37 What we did well What we could have done better Hired a consultant experienced with ISO Taken more ownership and gotten more involved sooner Established an ISO Steering Committee Started sooner and paced changes more reasonably

38 What we did well What we could have done better Communicated why and what to the entire organization Started sooner, and at the supervisor and bench level in small groups Set a timeline and never gave up, although adjusted as needed More thoroughly understood the time and resources required to make the necessary changes

39 What we did well What we could have done better Self-assessments and audits Celebrated the success Been more realistic about the current state (i.e., stay positive, but don t sugarcoat) Continually communicated the small successes and progress during the process, in a way that showed the value to the individual employee

40 Was it worth it? Yes! Early stages Unified in a common goal Finding more opportunities Value of the new systems will be proven over time

41 Thank you!

42 Questions?