PN / Report PER about the mission from 11 th 15 th Nov 2012 at Lima - Peru

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1 Report PER about the mission from 11 th 15 th Nov 2012 at Lima - Peru PTB-Project Establishment of a demand-oriented and regionally harmonized quality infrastructure in the Andean Region ordered by Physikalisch-Technische Bundesanstalt Bundesallee 100, Braunschweig Reported by: Manfred Kindler Kindler International Division Stemmenkamp Werne Kindler Report PER /25

2 Report PER 2012 Establishment of a demand-oriented and regionally harmonized quality infrastructure in the Andean Region Content 1 Task of the mission 2 Program 3 Results Planning session Part I with SNA staff Meeting with representatives of the public sector Assessor training on new edition ISO 15189:2012 Planning session Part II with SNA staff Annexes I 30 Milestones Program SNA-Clinical Lab II Minutes of the 30 MS evaluation III 30 MS Action Plan Spanish version IV Participants of the events 1 Task of the mission Based on a work contract following tasks were ordered by PTB: Analysis of the actual state of INDECOPI SNA accreditation body for accreditation of clinical laboratories based on ISO with the 30 Milestones Program; Advisory of the accreditation body and SNA assessors and recommendations for further development; Introduction of the local expert Ms. Imilce Zuta into the 30 MS analysis and qualification to assure the continuing consultancy of INDECOPI; 1-day awareness workshop Accreditation of clinical laboratories Meeting with representatives of Ministry of Health. Kindler Report PER /25

3 2 Program During one and a half day several activities were done: - Three planning sessions about the 30 milestones program for clinical laboratories: Analysis, long-term plan, action plan) - Awareness meeting with representatives of the public sector about the need for accreditation of clinical laboratories - Training session with SNA assessors and laboratory experts about the new edition of ISO 15189:2012 Kindler Report PER /25

4 3 Results Planning session with SNA staff As planning tool for the implementation of the new accreditation area a roadmap with milestones was used. The components are grouped to four support sources: 1. Political Support: National Policy, National Coordination, Legal Status, Financial Policy, First Scope, Independency, Monopole 2. Administration: Legal Entity, Director, Location, Management Structure, Equipment, Personnel, Quality Documentation, Public Relations 3. Technical Support: Lead Assessors, Technical Assessors, Training System, Technical Committees, Metrology, Preliminary visits, Proficiency Testing, Working Groups, Special Courses 4. External Relations: Control Board, Associations, Joint Accreditations, Client Organisation, Pre-Evaluation, MRA / MLA ROJO Aspectos Políticos AZUL Administración ILAC - IAF AMARILLA Aspectos Técnicos VERDE Relaciones Externas 30 IAAC Sistema de Acreditación de Reconocimiento Internacional Acuerdo Reconocimiento Mutuo de IAAC La Casa de la Acreditación 28 Pre-Evaluación de Pares Relaciones Publicas 26 Cursos Especiales Monopolio Grupos de Trabajo Documentación de 11 Calidad 21 Ensayos de Aptitud Alcance 10 Personal 20 Visitas preliminares Organizaciones des Clientes Evaluaciones Conjuntas Política Financiera Competencia Legal 2 6 Coordinación Nacional Equipos 19 8 Estructura de Gestión Ubicación Director Naturaleza Jurídica Independencia Metrología Comité Técnico 17 Sistema de Entrenamiento Auditores Técnicos Auditores Líderes Asociaciones internacionales Organismo de Control 1 Política Nacional The 30 Milestones are visualized as bricks of a house NAB. The four columns represent the political, administrational, technical and external support; the two horizontal stabilizers are the milestones National Policy and Independency. In the next schemes the bricks of this house are alternatively coded with the three colors defining the condition of completion: red (no activities have been implemented yet), yellow (work is in progress) and green (work is almost or fully completed), which visualize the actual state of the construction. Kindler Report PER /25

5 30 Milestones Evaluation of INDECOPI SNA Section Clinical Laboratories The actual situation of INDECOPI SNA accreditation scheme for clinical laboratories was evaluated by using the following scale of 10 degrees: Condicio Rojo: Acciones teóricas 0 0% Ninguna acción ha sida planificada 1 10% Tener conciencia de la necesidad 2 20% Presentar los registros de las primeras ideas 3 30% Presentar el concepti desarrollado Condicio Amarillo: Acciones prácticas 4 40% Implementar las primeras acciones 5 50% Presentar los registros de los primeros resultados 6 60% Haber completado al menos el 50% de las acciones 7 70% Haber completado más del 50% de las acciones Condicion Verde: Efectos constantes 8 80% Presentar los registros de los efectos constantes 9 90% Pocas acciones por finalizar % Las metas se han alcanzado, aprobado y documentado The way of establishing accreditation bodies should be similar to the construction of a house: first start with the fundament, continue from the bottom to the top and end with the construction of the roof. Kindler Report PER /25

6 The construction plan is presented by a simplified roadmap. At the moment SNA has not yet installed the first implementation steps as the national policy for accreditations in the healthcare sector, the national coordination with the Ministry of Health and related institutions and associations, the budget to finance the extension of the scope and the necessary management structure. The RADAR-diagram visualizes the planned progress from November 2011 till August 2014 in steps of three months. Kindler Report PER /25

7 For each milestone an actionplan was developed. A time schedule for the roadmap to the final recognition by IAAC MRA till summer 2014 was designed and discussed with SNA staff. For details see Annex I, II and III. Kindler Report PER /25

8 Assessor training on new edition ISO 15189:2012 On the second day a training of SNA assessors and staff about the changes of the third edition of ISO 15189:2012 was given. The main aspects of new standard were presented, discussed and strategies for implementation developed. Kindler Report PER /25

9 Meeting with representatives of the public sector On the first mission day an Awareness Meeting with high-ranking members of ministries, industry, trade and other shareholders was planned by INDECOPI. The feedback of the invited persons (more than 20) was extremely poor. Only one representative of a laboratory appeared, later on Prof. Dr. Eleazar Antonio Antúnez de Mayolo of the Facultad de Medicina Alberto Hurtado, Universidad Peruana Cayetano Heredia arrived. As the president of the Peruvian Association of Clinical Laboratory Professionals APPLAC, he presented the national PT scheme for clinical laboratories in Perú, where monthly nearly 100 laboratories participate. This meeting initiated an intensive discussion about thinkable models of the cooperation of INDECOPI with main players of the healthcare sector in Peru over two hours Kindler Report PER /25

10 Recommendations The 30 milestones program should be used and maintained by SNA-Lab department under the support of Ms Imilce Zuta to develop the new accreditation service. Especially the work plans of some milestones need further developments. Designation of technical experts of INDECOPI SNA for assessments and membership in a technical committee for ISO accreditation by using the expertise of APPLAC, Ministry of Health and attached institutions. Correction of deficiencies in the INDECOPI work conditions by extension of the office facilities. Additional staff has to be hired, for example a head of the new department, a case officer and assistants. Continuation of the Awareness meetings and visits of the important player in the Healthcare sector in Perú. More detailed recommendations are listed in Annex II and III. Kindler Report PER /25

11 Annex I: 30 Milestones Program for SNA - Clinical Lab: Only four milestones are in a sustainable condition. The goal for the next six months is to plan and implement the white-colored components, especially the administration and technical components. The progress in the political part (left column) depends on political decisions about the National Quality Policy, coordination with Ministry of health and connected institutions, the Budgeting and the monopole in accreditation of clinical laboratories. Kindler Report PER /25

12 30 Milestones Program for SNA Section Clinical Lab: After the start of implementation of all milestones sustainable efforts should be produced in all four sections: the decision about the first scope (including veterinary, forensic, doping control labs or not); the coordination with the national healthcare sector; the completion of the facilities by extension of office rooms; the provision of specific technical competence by alliances and the cooperation with IAAC members. End of 2013 SNA LabClin would be fit for a Pre Peer Evaluation as an extension of an IAAC surveillance visit in the lab sector. The signature of IAAC MRA for clinical lab accreditation is planned for summer Kindler Report PER /25

13 Annex II: Minutes of the 30 MS evaluation English version Issued by Ms Imilce Zuta Kindler Report PER /25

14 Kindler Report PER /25

15 Minutes of the 30 MS evaluation Spanish version Kindler Report PER /25

16 Kindler Report PER /25

17 Kindler Report PER /25

18 Annex III: 30 MS Action Plan Spanish version La Mesa de Trabajo está conformada por: César Cabezas (INS), Augusto Mello / Patricia Aguilar (INDECOPI-SNA), Antonio Antúnez (APPLAC), Imilce Zuta (PTB) Kindler Report PER /25

19 Kindler Report PER /25

20 Annex IV: Participants of the events Planning session Part I with SNA staff Kindler Report PER /25

21 Meeting with representatives of the public sector Kindler Report PER /25

22 Planning session Part II with SNA staff Kindler Report PER /25

23 Assessor training on new edition ISO 15189:2012 Part I Kindler Report PER /25

24 Assessor training on new edition ISO 15189:2012 Part II Kindler Report PER /25

25 Planning session Part III with SNA staff Kindler Report PER /25

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