The CLSI Experience: Implementation of Laboratory Quality Management Systems in Resource-Limited Settings

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1 The CLSI Experience: Implementation of Laboratory Quality Management Systems in Resource-Limited Settings Patrick Mateta, MBA, MT, CQA (ASQ) Senior International Program Manager

2 3 Things to Learn From This Talk 1. Quality lab testing can be achieved in resource-limited settings only by creating a quality CULTURE organized within a QMS. 2. It takes commitment by champions and engagement at every level. 3. Continual improvement starts at any level, leading to accreditation and high reliability. Abbreviation: QMS, quality management system.

3 Our Vision Quality practices for better health. Free Wind 2014 / Shutterstock.com

4 Our Mission Develop clinical and laboratory practices and promote their use worldwide.

5 CLSI Consensus Process

6 Global Health Partnerships

7 Global Health Partnerships (GHP) Grant funding: CDC through the US President s Emergency Plan for AIDS Relief (PEPFAR) Contracts: corporations, hospitals, governments, etc. Staff: 5

8 Where We Are

9 GHP Program Goals Build local laboratory capacity. Implement and sustain quality management systems. Ensure consistency and quality in testing performance. Implement best practices.

10 The Patient in the Quality Management System Patient Clinician assessment Clinician response Path of Workflow Quality System Essentials

11 Our Program Cycle Phases

12 Phase 1: Gap Analysis I Baseline Assessment Crosswalk Checklist Current Processes and Procedures

13 Phase 2: Training and Education

14 Phase 2: Training and Education

15 Phase 2: Training and Education

16 Phase 3: Mentorship Ini7al Assessment Plan How to Implement Implement the Plan: Delivery Conduct/Evaluate Gap Analysis

17 Working Side by Side: Mentoring

18 Mentoring Approach Lectures Demonstra7ons Discussions Planning and Priori7zing Work Follow- up Posi7ve Reinforcement

19 Conducting Assessments

20 Plan How to Implement Use the results of the baseline assessment to identify opportunities for improvement. Involve the laboratory personnel in developing the plan. Assign responsibility and timelines Come to an agreement with the laboratory team on the plan.

21 Implement the Plan: Delivery Mentorship Approaches One-to-one Mentor to one mentee Mentor to different individuals one by one One-to-many One to a group One to a few, who in turn train their colleagues

22 Phase 5: Continual Improvement Plan Do Check Act Develop QMS documents that comply with the standard. Train staff on the standard (ISO 15189). Implement processes and procedures. Generate records to show use of approved documents. Review internal audits, monitor metrics, and participate in proficiency testing. Monitor assessments to identify gaps. Identify and implement necessary corrective actions.

23 Phase 6: Conduct Gap Analysis II The mentor conducts a gap analysis. - This final assessment determines what remains to be done. Assignments are left to the laboratory by the mentor. - This step informs everyone about the path forward.

24 Success Drivers Management Commitment Sets the direction and goals Engages in quality management Provides adequate resources People Drive the process Must be competent, motivated, and engaged Technology Support the quality goals and objectives through processes and systems

25 Stakeholder Engagement Clinicians Laboratory Suppliers Government

26 Benefits Culture of quality Consistently accurate, timely service Customer and employee satisfaction Continual improvement of processes Compliance with regulatory and accreditation requirements Increased productivity and efficiency Reduced cost from operational failures

27 Results 9 laboratories accredited in 4 countries Mali (1), Namibia (1), Tanzania (6), and Kenya (1) Abbreviations: SADCAS, Southern African Development Community Accreditation Service; SANAS, South African National Accreditation System.

28 QMS Implementation Gap Analysis (Kazakhstan) Abbreviation: NCE, nonconforming event management.

29 QMS Implementation Gap Analysis (Kazakhstan) NOTE: Column headings correspond with quality system essentials introduced on the previous slide Yellow indicates a gain in compliance with standards in the given area

30 Improved Laboratory Services (Vietnam)

31 Capacity Building Activities (Tanzania)

32 Key Challenges Engagement in implementing a QMS Gaining clinicians confidence and trust in the laboratory testing Sustainability of the program

33 In Conclusion Implementing a QMS is fundamental to accreditation. People are your drivers of change: mentor, invest in, and empower them. Continual improvement can begin at any level to result in a high-reliability organization.

34 Celebrating With Them

35 Questions?

The CLSI Experience: Implementation of Laboratory Quality Management Systems in Resource-Limited Settings

The CLSI Experience: Implementation of Laboratory Quality Management Systems in Resource-Limited Settings Patrick Mateta, MBA, MT, CQA (ASQ) Senior International Program Manager 3 Things to Learn From