Patrick Mateta, MBA, MT, CQA (ASQ)Senior International Program Manager

The CLSI Experience: Implementation of Laboratory

Quality Management Systems in Resource-Limited Settings

1. Quality lab testing can be achieved in resource poor 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…to attain accreditation and become a high-reliability laboratory

3 Things to Learn From This Talk

Quality practices for better health.

Our Vision

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Develop clinical and laboratory practices and promote their use worldwide.

Our Mission

CLSI Consensus Process

Global Health Partnerships

20+Number of resource-constrained countries we are working in

10+Number of partners we collaborate with worldwide

100+Workshops that have allowed GHP Staff to reach over 4,000 laboratory professionals globally

• Grant funding: CDC via the US President’s Emergency Plan for AIDS Relief (PEPFAR)

• Contracts: corporations, hospitals, governments, etc.

• Staff: 5

Global Health Partnerships (GHP)

Where We Are…

• Build local laboratory capacity• Implement and sustain quality management systems

• Ensure consistency and quality in testing performance

• Implement best practices

GHP Program Goals

The Patient in theQuality Management System

Patient

Path of Workflow

Clinician assessment Clinician response

Quality System Essentials

Phases

Our Program Cycle

Phase 1: Gap Analysis I

Baseline Assessment

Crosswalk Checklist 

Current Processes and Procedures

Phase 2: Training and Education

Phase 2: Training and Education

Training and Education

Phase 3: Mentorship

Initial AssessmentInitial Assessment

Plan How to Implement Plan How to Implement 

Implement the Plan: DeliveryImplement the Plan: Delivery

Evaluate/Conduct Gap Analysis Evaluate/Conduct Gap Analysis 

Working Side-By-Side: Mentoring

Mentoring Approach

Lectures

Demonstrations

Discussions

Planning and Prioritizing Work

Follow Up

Positive Reinforcement

Conducting Assessments

• 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

Plan How to Implement

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

Implement the Plan: Delivery

• Develop QMS documents that comply with the standard

• Train staff on the standard (ISO 15189)Plan Plan

• Implement processes and procedures• Generate records to show use of approved

documentsDoDo

• Review internal audits, monitor metrics, and proficiency testing

• Monitor assessments to identify gapsCheckCheck

• Corrective Actions

ActAct

Phase 5: Continual Improvement

• 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 informs everyone about the path forward

Phase 6: Conduct Gap Analysis II

• Sets the direction and goals• Engages in quality management• Provides adequate resources

Management Commitment

• Drive the process• Must be competent, motivated,

and engagedPeople

• Processes and systems support the quality goals and objectivesTechnology

Success Drivers

Stakeholder Engagement

Clinicians Laboratory Suppliers Government

• 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

Benefits

9 laboratories accredited in 4 countries – Mali (1), Namibia (1), Tanzania (6), and Kenya (1)

Results

2010Laboratory 1 accredited to ISO 17025 by SANAS and laboratory 2 achieves CAP accreditation

2012Laboratories 1 and 2 receive SANAS and CAP reaccreditation

2012Six laboratories apply for accreditation to ISO 15189

2014Four laboratories accredited by SADCAS

2015Three labs accredited

QMS Implementation Gap Analysis (Kazakhstan)

QMS Implementation Gap Analysis (Kazakhstan)

Yellow – indicates a gain in compliance with standards in the given area

POST GAP ANALYSIS

% Complete OR CF FS PE PI EQ PM DR IM NC AS CI Overall

100% 80% 60% 40% 20% 0% Percentage 79 46 84 81 78 87 81 91 89 89 80 93 82

PRE GAP ANALYSIS

% Complete OR CF FS PE PI EQ PM DR IM NC AS CI Overall

100% 80% 60% 40% 20% 0% Percentage 60 46 41 43 12 34 25 29 7 29 16 27 31

Improved laboratory Services (Vietnam)

Capacity Building Activities (Tanzania)

• Engagement in implementing a quality management system

• Gaining clinicians’ confidence and trust in the laboratory testing

• Sustainability of the program

Key Challenges

• Implementing a quality management system is fundamental to accreditation

• People are your drivers of change: mentor, invest, and empower them

• Continual improvement can begin at any level to become a high reliability organization

In Conclusion

Celebrating With Them…

Questions?