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Implementa)on of
Laboratory Quality Management Systems
Alex Costa World Health Organiza)on
6th ACDx, Annecy, France 8 September 2015
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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.
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3 | LQMS Implementa)on
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
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4 | LQMS Implementa)on
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
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5 | LQMS Implementa)on
Laboratory Quality Management Tools
LABORATORY QUALITY STEPWISE IMPLEMENTATION (LQSI) TOOL
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6 | LQMS Implementa)on
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
Laboratory Improvement
Projects
Workshop #3
Laboratory Improvement
Projects
Site Visits
Site Visits
Behavioral Changes
& Laboratory
Improvement
Laboratory Assessment
Laboratory Assessment
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7 | LQMS Implementa)on
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
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8 | LQMS Implementa)on
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
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9 | LQMS Implementa)on
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.
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10 | LQMS Implementa)on
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.
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11 | LQMS Implementa)on
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.
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12 | LQMS Implementa)on
Interac1ve roadmap for each phase:
Provides the recommended order of ac)vi)es for day-‐to-‐day implementa)on
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13 | LQMS Implementa)on
Ac1vi1es:
What must be done explained in one sentence
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14 | LQMS Implementa)on
Explana1on:
On the Why, What, How & Who of the ac)vity
Support materials:
Where possible, links are provided to templates and training materials
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15 | LQMS Implementa)on
Interac1ve checklist:
Enables laboratory assessors and staff to assemble checklists to assess implementa)on of the quality management system
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16 | LQMS Implementa)on
LQSI Implementa)on Plan: Baseline assessment
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17 | LQMS Implementa)on
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:
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18 | LQMS Implementa)on
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:
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19 | LQMS Implementa)on
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:
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20 | LQMS Implementa)on
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
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21 | LQMS 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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22 | LQMS Implementa)on
Thanks