Implementaon+of++ Laboratory+Quality+ManagementSystems · Management Quality+System+...

Implementa)on of

Laboratory Quality Management Systems

Alex Costa World Health Organiza)on

6th ACDx, Annecy, France 8 September 2015

2 | LQMS Implementa)on

Laboratory Quality Management System

Inspec)on

Quality Management

Quality System

Quality Assurance

Quality Control Detect and correct problems when they occur (e.g., IQC)

Subconscious inspec>on of work by laboratory technologist

Prevent problems from happening (e.g., SOPs, EQA)

Organiza>onal structure necessary to ensure that all staff, materials and resources are present at the right place, >me, and in sufficient amounts.

Planning, leadership, management, monitoring and evalua>on of the quality system.


Benefits of Laboratory Quality Management

§  Accurate and )mely diagnosis

§  Reduced costs

§  Faster response to public health events

§  More efficient use of resources

§  More confidence in laboratories


Laboratory Quality System Essen)als

12 Quality System Essen1als:

§  Based on ISO 15189

§  Framework organized by CLSI

§  Essen)al requirements for control, assurance and management of quality in the laboratory.

CLSI GP2

6-‐A3


Laboratory Quality Management Tools

LABORATORY QUALITY STEPWISE IMPLEMENTATION (LQSI) TOOL


Strengthening Laboratory Management Towards Accredita)on (SLMTA)

§  A training and mentoring program developed to promote immediate and measurable improvements in laboratories of developing countries.

§  Teaches laboratory managers how to implement prac)cal quality management systems in resource-‐limited se]ngs using available resources.

§  A series of short courses and work-‐based improvement projects supported by site visits and mentoring.

§  Implemented in more than 617 laboratories in 47 countries worldwide since 2009.

Workshop #1

(4 months) (4 months) (4 months)

Site Visits

Laboratory Improvement

Projects

Workshop #2


Projects

Workshop #3


Projects

Site Visits

Site Visits

Behavioral Changes

& Laboratory

Improvement

Laboratory Assessment

Laboratory Assessment


SLMTA in Cambodia

0% 10% 20% 30% 40% 50% 60% 70% 80%

Lab 1

Lab 2

Lab 3

Lab 4

Lab 5

Lab 6

Baseline

1st Assessment


Baseline vs Exit assessment

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

1.Documents&records

2.Mgt review

3.Org&personnel

4.Client Mgt

5.Equipment

6.Internal Audit

7.Purchasing&inventory

8.Press control

9.Info.Mgt

10.Correc_ve ac_on

11.Occurrence Mgt

12.Facili_es&Safety

Baseline

Exit


Challenges for SLMTA implementa)on

§  Low quality of local mentors and assessors. §  Lack of LQMS understanding and commitment among hospital directors, lab directors, and lab staff.

§  Inefficient mentoring and monitoring of par)cipa)ng labs.

§  Language barrier.


Future plans

§  Revise and improve checklist. §  Improve the knowledge of mentors through training and competency assessments.

§  Promote lab-‐to-‐lab interac)ons and visits. §  Improve monitoring and support for improvement projects.

§  Target training to common challenges across labs.


Laboratory Quality Stepwise Implementa)on (LQSI) tool

§  Developed by WHO and Royal Tropical Ins)tute. §  Web-‐based tool, freely accessible and downloadable. §  Structured according to the CLSI 12 quality system essen)als.

§  Translates ISO 15189 requirements into step-‐by-‐step ac)vi)es divided in 4 phases and structured as an interac)ve roadmap.


Interac1ve roadmap for each phase:

Provides the recommended order of ac)vi)es for day-‐to-‐day implementa)on


Ac1vi1es:

What must be done explained in one sentence


Explana1on:

On the Why, What, How & Who of the ac)vity

Support materials:

Where possible, links are provided to templates and training materials


Interac1ve checklist:

Enables laboratory assessors and staff to assemble checklists to assess implementa)on of the quality management system


LQSI Implementa)on Plan: Baseline assessment


LQSI implementa)on cycle

Phase 1

Phase 2

Phase 3

Phase 4

Lab 1

Lab 3

Lab 2

1st Rota)on = 3 weeks 2nd Rota)on = 3 weeks 3rd Rota)on = 3 weeks

Lab 1

Lab 3

Lab 2

Lab 1

Lab 3

Lab 2

Training (1

week)

Assure technical competency of tes)ng (n = 104 ac)vi)es)

Implement QC measures, create traceability (n = 178 ac)vi)es) Ensure proper management, leadership

and organiza)on (n = 129 ac)vi)es) Create con)nuous improvement and prepare

for accredita)on (n = 54 ac)vi)es)

Ac_vity set # 1 Ac_vity set # 2 Ac_vity set # 3

Assessments Courtesy of:


LQSI (Phase 1) implementa)on

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100% Ba

selin

e

Sep-‐14

Oct-‐14

Nov-‐14

Dec-‐14

Jan-‐15

Feb-‐15

Mar-‐15

Apr-‐15

May-‐15

Jun-‐15

Jul-‐1

5

Aug-‐15

Percen

t implem

enta_o

n of 104

item

s

Svay Rieng

Kampong Cham

Kossamak

Na_onal Pediatric

Takeo

Kampot

Prey Veng

Sihanukville

Kra_e

Kandal

Courtesy of:


LQSI (Phase 2) implementa)on

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Baselin

e

Feb-‐15

Mar-‐15

Apr-‐15

May-‐15

Jun-‐15

Jul-‐1

5

Aug-‐15

Percen

t implem

enta_o

n of 178

item

s

Svay Rieng

Kampong Cham

Kossamak

Na_onal Pediatric

Takeo

Kampot

Prey Veng

Sihanukville

Kra_e

Kandal

Courtesy of:


LQSI Implementa)on: Challenges & Lessons

§  Limited commitment by laboratory staff -  Ensure leadership (MoH, hospital, and lab) support for implementa)on

§  Significant addi_onal work by lab staff is necessary -  In-‐service support by laboratory mentors to provide guidance and encouragement

§  Construc_ve approach to carry out LQSI implementa)on -  Focus on the posi)ves and benefits of contribu)ng to lab quality improvements

§  All materials have to be translated §  Regular assessments to measure impact of implementa)on


Acknowledgments

Ministry of Health of Cambodia

Defense Threat Reduc_on Agency

Integrated Quality Laboratory Services

US Centers for Disease Control and Preven_on

Interna_onal Training & Educa_on Center for Health

Diagnos_c Microbiology Development Program

Naval Medical Research Unit -‐ 2

Fonda_on Mérieux


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