Implementa)on of Laboratory Quality Management Systems

Transcription

1 Implementa)on of Laboratory Quality Management Systems Alex Costa World Health Organiza)on 6 th ACDx, Annecy, France 8 September 2015

2 Laboratory Quality Management System Quality Management Quality System Quality Assurance Quality Control Inspec)on Planning, leadership, management, monitoring and evalua>on of the quality system. Organiza>onal structure necessary to ensure that all staff, materials and resources are present at the right place, >me, and in sufficient amounts. Prevent problems from happening (e.g., SOPs, EQA) Detect and correct problems when they occur (e.g., IQC) Subconscious inspec>on of work by laboratory technologist 2 LQMS Implementa)on

3 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 3 LQMS Implementa)on

4 Laboratory Quality System Essen)als 12 Quality System Essen1als: Based on ISO Framework organized by CLSI Essen)al requirements for control, assurance and management of quality in the laboratory. CLSI GP26- A3 4 LQMS Implementa)on

5 Laboratory Quality Management Tools LABORATORY QUALITY STEPWISE IMPLEMENTATION (LQSI) TOOL 5 LQMS Implementa)on

6 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 Laboratory Assessment Workshop #1 (4 months) (4 months) (4 months) Laboratory Improvement Projects Workshop #2 Laboratory Improvement Projects Workshop #3 Laboratory Improvement Projects Laboratory Assessment Behavioral Changes & Laboratory Improvement Site Visits Site Visits Site Visits 6 LQMS Implementa)on

7 SLMTA in Cambodia Lab 6 Lab 1 80% 70% 60% 50% 40% 30% 20% 10% 0% Lab 2 Lab 5 Lab 3 Baseline Lab 4 1st Assessment 7 LQMS Implementa)on

8 Baseline vs Exit assessment 11.Occurrence Mgt 10.Correc_ve ac_on 12.Facili_es&Safety 1.Documents&records 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 2.Mgt review 3.Org&personnel 4.Client Mgt 9.Info.Mgt 5.Equipment 8.Press control 7.Purchasing&inventory 6.Internal Audit Baseline Exit 8 LQMS Implementa)on

9 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. 9 LQMS Implementa)on

10 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. 10 LQMS Implementa)on

11 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 requirements into step- by- step ac)vi)es divided in 4 phases and structured as an interac)ve roadmap. 11 LQMS Implementa)on

12 Interac1ve roadmap for each phase: Provides the recommended order of ac)vi)es for day- to- day implementa)on 12 LQMS Implementa)on

13 Ac1vi1es: What must be done explained in one sentence 13 LQMS Implementa)on

14 Support materials: Explana1on: On the Why, What, How & Who of the ac)vity Where possible, links are provided to templates and training materials 14 LQMS Implementa)on

15 Interac1ve checklist: Enables laboratory assessors and staff to assemble checklists to assess implementa)on of the quality management system 15 LQMS Implementa)on

16 LQSI Implementa)on Plan: Baseline assessment 16 LQMS Implementa)on

17 LQSI implementa)on cycle Training (1 week) Lab 1 Lab 1 Lab 1 Lab 2 Lab 2 Lab 2 Lab 3 Lab 3 Lab 3 1 st Rota)on = 3 weeks 2 nd Rota)on = 3 weeks 3 rd Rota)on = 3 weeks Assure technical competency of tes)ng (n = 104 ac)vi)es) Phase 1 Implement QC measures, create traceability (n = 178 ac)vi)es) Phase 2 Ensure proper management, leadership and organiza)on (n = 129 ac)vi)es) Phase 3 Create con)nuous improvement and prepare for accredita)on (n = 54 ac)vi)es) Phase 4 Assessments Ac_vity set # 1 Ac_vity set # 2 Ac_vity set # 3 Courtesy of: 17 LQMS Implementa)on

18 LQSI (Phase 1) implementa)on Percent implementa_on of 104 items 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% Svay Rieng Kampong Cham Kossamak Na_onal Pediatric Takeo Kampot Prey Veng Sihanukville Kra_e Kandal 0% Baseline Sep- 14 Oct- 14 Nov- 14 Dec- 14 Jan- 15 Feb- 15 Mar- 15 Apr- 15 May- 15 Jun- 15 Jul- 15 Aug- 15 Courtesy of: 18 LQMS Implementa)on

19 LQSI (Phase 2) implementa)on Percent implementa_on of 178 items 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% Svay Rieng Kampong Cham Kossamak Na_onal Pediatric Takeo Kampot Prey Veng Sihanukville Kra_e Kandal 0% Baseline Feb- 15 Mar- 15 Apr- 15 May- 15 Jun- 15 Jul- 15 Aug- 15 Courtesy of: 19 LQMS Implementa)on

20 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 20 LQMS Implementa)on

21 Acknowledgments Ministry of Health of Cambodia Defense Threat Reduc_on Agency Integrated Quality Laboratory Services Diagnos_c Microbiology Development Program Naval Medical Research Unit - 2 Fonda_on Mérieux US Centers for Disease Control and Preven_on Interna_onal Training & Educa_on Center for Health 21 LQMS Implementa)on

22 22 LQMS Implementa)on Thanks