How it all began NATIONAL INSTITUTE OF HEALTH DR. RICARDO JORGE

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1 NATIONAL INSTITUTE OF HEALTH DR. RICARDO JORGE Founded in 1989, first in Oporto and later at Lisbon by the phisician and humanist Dr. Ricardo Jorge Maria Adelina Gomes/Coordinator PNAEQ INSA Lisbon - Portugal ( /12) The decision to establish INSA, was taken with the need to combat an outbreak of bubonic plague that reached the city of Oporto that year. National Institute of Health Dr. Ricardo Jorge The image "Instituto Ricardo Jorge" is a mark of prestige and scientific projection Qualified human resources to provide health care for the practice of biomedical research, epidemiological and clinical research and also for action in several sectors outside of health care; Promote, organize and ensure the External Quality Assessment in the laboratory (*) - clinical laboratories and environmental; Provide analytical services differentiated (in particular in the function reference) to a wide variety of individual and institutional clients, public and private. (*) Law nº 271/2007 One of the missions of INSA PORTUGUESE EXTERNAL QUALITY ASSESSMENT VERY IMPORTANT: Rectrospective assessment of the performance of the portuguese laboratories WHO Working Group (1979) How it all began Considered the need to implement National Schemes of Quality Control in differents disciplines of Pathology 1

2 AEQ is a tool for Public Health OBJECTIVES OF THESE PROGRAMS Patient Safety What objectives? Economic Impact It benefits the participating laboratories: - Identify and assess the capabilities of laboratories; - Drive laboratories in corrective action and improvement; - Provide continuing education for laboratory personnel in methods of diagnosis standard; - Raise awareness of the successes and changes in laboratory practice; - Provide information to defense. OBJECTIVES OF THESE PROGRAMS It benefits the programs of Public Health: INSA considering the importance of EQAS - Provide reliable data to guide the activities of public health (immunization, eruptive response,...); - Identify gaps and strategies for improving the skills laboratory; - Guide the planning and evaluation of training of the laboratory; - Identify laboratories of excellence; - Strengthening the laboratory network; - Provide information to the defense. one of the roles of Quality Control is to ensure the best possible early detection of errors, before a false result is given According Prof. D. STAMM... since 1966 HOW ARE N EQAS ORGANIZED IN PORTUGAL An responsible analyst shall not conduct any analysis without organizing a quality control system. No conscientious doctor must accept the result of clinical chemistry analysis without the uncertainty established by a quality control. PNAEQ / Portugal Organized by the National Institute of Health founded in Support of various Hospitals, Universities and recognised and competents Specialists of some Public Clinical Laboratories. OUR GURU! 2

3 The ORGANIGRAM of PNAEQ President of Board of INSA Serv. Provisioning Accounting (SAP) Off. Inf. Technology Off. Manag. Products (GIT) (GGP) Coordinator of GAEQ/PNAEQ Drª Maria Adelina Gomes Clinical Area POCT Organigram Environmental Area Coordination Drª Adelina Gomes Clinical Area Coordination Drª Ana Paula Faria Pathology of INSA Food Microbiology Drª Isabel C. Cunha Water Microbiology Drª Leonor Falcão Air Microbiology Health Protection Agency (HPA) Administrative Support Ana Paula Melo EQUASE/HPA Europe Technical Sector Drª Leonor Falcão Drª Claudia Pena Training Drª Ana Paula Faria Organizers Labs. / Experts INSA Publics Entities Technical Sector Drª Isabel C. Cunha Engª Cristina B. Correia Technical Consultants Drª Isabel Santos Drª Margarida Saraiva Administrative Sector -Cristina Brito - Maria José Mendes Technical Sector Drª Ana Paula Faria Drª Helena Correia Subcontrators Companies -LabQuality - SKML PNAEQ INSA the legislation PNAEQ INSA History of recognition of its importance. Legislation however published Ministerial decree number 18 of 10 November (DL No. 260) reinforces the existence of programs of INSA, The Organic Law of INSA published in Decree-Law number 307 of September 1, gave the Institute the responsibility for organizing this type of testing, Approval of the Minister of Health Dr. Paul Mendo (May 9th) of the Rules of the National Quality Control - collaboration with the Membership of Professional Associations of Physicians and Pharmacists. PNAEQ INSA the legislation Order No of 27 April (DR Series II), Article V, Section 3, licensing of laboratories, requiring laboratories to participate preference in national programs, recognizing the existence of the program INSA. National Health Plan 2004/ Volume II Strategics Orientations The new Organic Law of INSA, DL No 271 of 26 July, includes a new organization of these programs as one of the tasks of INSA. Annex II Nationals Programs Nº40. National External Quality Assessment Programs 3

4 PNAEQ - Goals achievements 2004/2010 To improve the performance indicators and decision support YEAR Nº programs Nº particip. labs Nº orders Nº technical acts To improve the quality of health care delivery EVOLUTION OF C.V.% IN IMPORTANTS AREAS OF PUBLIC HEALTH - Chronic Diseases Glicose 6,2 3,92 3,5 5,3 4,1 3,3 2,9 Cholesterol 5,2 3,93 4,4 4,7 3,4 3,5 3,1 Cooperation in monitoring IVDs - post-marketing Directive 98/79/EC - the data obtained in EQAS are very useful for monitoring the performance of equipment and reagents in each Member State. EN14136:2003 (Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures) - EQAS is able to contribute to the post-marketing monitoring of the IVD MDs as mentioned in Directive 98/79/EC on in vitro diagnostic medical devices to the benefit of both their manufacturers and.users. The PNAEQ/INSA in collaboration with the Regulator Institute for IVD, can provide continuous surveillance of the state-of-the-art of medical devices and health technology. ACCREDITATION, the EQAS role PNAEQ INSA Participation in interlaboratory tests is a legal and mandatory requirement for all laboratories (ISO / IEC / ISO 15189); Our history INSA is one of the national entities recognized as responsible for organizing interlaboratory tests, by the Portuguese Institute for Accreditation (IPAC) ( - document DRC005). 32 years of activity Clinical Area Year 1978 Water Microbiology Area Year 1996 Food Microbiology Area Year 2001 PNAEQ CLINICAL AREA PNAEQ INSA What evolution in data processing 4

5 PNAEQ INSA 1978 Clinical Area - 43 Labs (3 labs did not send its answer) PUBLICS LABS. The beginning NUMBER OF PORTUGUESES CLINICAL LABORATORIES ±??? Including Lab. of: MADEIRA ( 1) Organized by INSA Lisbon Starting the activity Public Clinical Laboratories Hospitals, Health Centers, Institutes and others publics laboratories Clinical Chemistry Area EVERYTHING WAS HANDMADE TARGET VALUES found in control materials by Reference Laboratories or consensus values CQ_1 (June 1978) Prof. Aloísio Coelho Sending preliminar ( ) and final relatory( ) Lab. Lab. Data handwritten by laboratories. Manual treatment of data and relatories CLINICAL CHEMISTRY SCHEME The Pre-1º Essay (1978) 17 analytes Values outliers eliminated outside of ±3 SD Statistical Analysis Handmade Clinical Chemistry C.V.% Albumine Bilirrubine Calcium Chloride Cholesterol Creatinine Iron Alkaline Phosfatase 68.1 Phosphorus Glucose Potassium 6.93 Total Protein 5.33 SGOT Natrium 4.25 Tryglicerides 16.4 Urates / Uric Acid Urea All CQ_3 (September 1981) CLINICAL AREA data Participating introduced Laboratories CQ_1 MANUAL manually Data handwritten by laboratories CQ_7 1 ª Software version CQ_20 2 ª Software version 2000 Software tool, statistical and image with rather outdated view to compete. RELATORIES - CALCULATIONS AND GRAPHICS DONE: MANUALLY 5

6 CQ_16 (January 1986) Participating Laboratories Data introduced manually; Results of each lab. not marked in the graphics; Relatory in a sheet of paper A3; Statistic treatment too basic. (Support of IGIF/Ministery of Health) CQ_53 (December 1992) Participating Laboratories Data introduced manually; Result of each lab. marked; Differents types of graphics; Treatment of data more completed; Relatories in a continual perforated paper. (Collaboration of IST) RELATORIES - CALCULATIONS AND GRÁPHICS DONE AUTOMATICALLY: A NEW (1st) SOFTWARE (CQ_07 / 1983) (2nd) SOFTWARE (CQ_20 / 1987) AUTHOMATICS SYSTEMS YEAR 2003 Year Candidature European Funds - Saúde XXI TARGET VALUES of the reference materials. Indicated by reference methods, or found by reference laboratories or value consensus A NEW SOFTWARE the 3rd one Especially done for PNAEQ/INSA SQL Server Clinical Chemistry CQ_142 (2005) Strengthen the relationship with INSARJ laboratories associated of the PNAEQ; Providing a best quality information; Reduce the period of availability, improving the making decision; Encourage the accession of new laboratories to PNAEQ; Increase the transparency of the process of EQA; PNAEQ INSA the evolution Simplify and automate procedures; Efficiency gains in the internal workings. PROJECT OBJECTIVES 6

7 H. pylori, RSV C.Trachomatis, PCR CMV, EBV, HIV, HSV, Varicela, sarampo N. gonorrhoeae, PCR B. pertussis, C. pneumoniae, B. burgdorferi Fase Pré Analitica; Fase Pós Analitica Hepatites A, B+C, Anti HBs quant., Rubeola Seg laboratorial Parasitologia (Toxo, hidat. morf. sg e fecal) Serologia (sifilis e brucella), enteropatogénios Endocrinologia M. pneumoniae, Parvovirus PTH Leitura de Abs Drogas de abuso Controlo para leitores de ELISA (screening e confirmação) Sg oculto, Teste gravidez Q.C, HbA1c, Urina II, Contagem celular, Dif. Leucocitaria, Coagulação Proteinas (electroforese) Hemoglobinopatias, Morf. Sg Periférico Reticulócitos (+mét. manuais) Coprocultura Est. Cels Med. Óssea Hemocultura (screening e TSA) Alergias VS, VS Alifax N. gonorrhoeae (cultura), Influenza A+B Imunologia Urocultura (screening e TSA), Micologia Autoimunidade Micobacteriologia (microscopia e TSA) Marc. Cardiacos Bacteriologia (Aerobios e Anaeróbios) Marc. Tumorais Coloração Gram, streptococcus Grupo A, S. Dow n Streptococcus faringeos, LCR Grupo de sangue Rotavirus e Adenovirus Teste antiglobulina Endocrinologia Equipamentos Hematologia Imuno-hematologia Imunologia Microbiologia Quimica clinica Serologia Microbiana Biologia Molecular Monitorização de Erros Organized by INSA Lx, Oporto 32 years of activity 288 Clinical laboratories (Publics and privates) 70 laboratories (Water) 41 laboratories (Food) 10 laboratories (Air) 82 differents clinical areas Including Labs. of: AÇORES ( 6 5) Nº Laboratórios PNAEQ INSA Actives Participants Clinical Chemistry Year Labs Activos Labs N Activos Clinical Chemistry Years MADEIRA ( 3 3) Bacteriological Serology PNAEQ INSA 2010 Total Labs LABS. PRIVATES LABS. PUBLICS MACAU ( 1) NUMBER OF PORTUGUESE CLINICAL LABORATORIES Bacteriological Serology Years SerolB35 SerolB36 SerolB37 Nº Participantes Activos Nº Participantes N Activos ± 350 Nº Essays % Corrects values TRIGLYCERIDES Evidence of improved performance Essays Graphic 1: Evolution of the nº of programmes in the last 6 years and in differents areas Graphic 2: Distribution of our Programmes by differents areas of PNAEQ the more recent has started at August 2009: PNAEQ Mycobacteriology Test the sensibility to the 1st line anti-tuberculosis drugs. STATISTICAL EVALUATION - different types of treatment, depending on the type of data / laboratory area In according to ISO Guide 43, target values can be obtained by three different types of treatment: What kind of statistical evaluation of data we use Methods of Reference 2. Reference Laboratories 3. Consensus Value According to the Guide EURACHEM (1999) the decision between these three types of calculations depends on the objective of interlaboratory tests: 1. Encourage the production of true results 2. Get an agreement between the participants of the program. 7

8 Reference Measurement Systems REFERENCE MATERIALS / PROCEDURES In Vitro Diagnostic Directive (2007/47/CE) the traceability of values assigned to calibrators Reference Materials Reference Measurement Procedures Reference Laboratories and control materials available reference must be assured through measurement procedures and/or reference materials or higher order.. Reports shall include the following unless it is not applicable or the PT provider has valid reasons for not doing so: Reference Materials -- details of the metrological traceability and measurement uncertainty of assigned value. 30/03/2009 JRC-IRMM has developed a new clinical reference material for the liver enzyme, aspartate transaminase (AST/SGOT) - also called aspartate aminotransferase (ASAT). REFERENCE METHODS 2 essays European level BCR INSA (1995) IRMM / IMEP Portuguese laboratories (2003) Creatinine HPLC ID-GCMS ID-LCMS Cholesterol GCMS Abell-Kendall All analites CV%<1,5% ID-GCMS ID-LCMS Glucose GCMS ID-GCMS Na / K AA AA Chloride Coulometry Coulometry Human Serum certified values with traceability and know uncertainty A New Laboratory: 1) 1) GC-MS (Ion Trap) 2) HPLC 3) GC-FID 4) GCMS (Single Quadrupole) REFERENCE LABORATORIES / EXPERTS 2) 3) 4) 8

9 Reference Laboratories / Experts Definition: 1. Well equipped, highly qualified clinical laboratories, appointed in advance to establish target results in a batch of sample. 2. Reference laboratories have to use the exactly agreed special protocol for the evaluation of the target results. Target values of minimum 6 laboratories. Our collaborators: Drª Anabela Silva - INSA Porto Drª Armandina Miranda - INSA Lx Drª Conceição Cerveira H. Stº António Porto Drª Cláudia Júlio - INSA Lx Drª Deolinda Madureira - IPO Lx Drª Esmeraldina Correia Junior H. S. F. Xavier Lx LABORATORIES - ORGANIZERS Dr. Rui Barreira e Dr. José Cortez IPO Lx Prof. Doutor Manuel Santos Rosa - F. Med. Coimbra Drª Maria Teresa Seixas - INSA Lx Drª Paula Palminha - INSA Lx Drª Rita Matos - INSA Lx Drª Margarida Silveira IPO F. Gentil Lx Drª Filomena Rodrigues - INSA Porto - Dr. João Fernandes Ribeiro - H S. Teotónio Viseu Dr. João Mario Pestana H.S.F.Xavier Lx Dr. José Carlos Oliveira - H Stº António Porto Drª Alcina Costa INSA Lisboa Drª Lisete Fonseca e Silva - INSA Porto Dr. Paulo Ratado H. Sousa Martins Guarda Drª Ana Batalha Reis - H. S.F. Xavier Lx Drª Fátima Martins - INSA Lx Drª Helena Cortes Martins - INSA Lx LABORATORIES - EXPERT LABORATORIES - COLLABORATORS Drª Helena Proença - H. Santa Maria Lx Drª Mariana Martins - H. Am. Lusitano C. Branco Dr. Ricardo Castro H. Sto André Leiria Drª Letícia Ribeiro H. Covões Coimbra Drª Zulmira Peerally - Lab. APDP Dr. Ricardo Castro H. Sto André Leiria Drª Maria João Simões - INSA Lx Drª Paula Barreiro - INSA Lx Dr. Ricardo Camacho - H. Egas Moniz Lx Doutora Laura Rosado - INSA Lx - α Amylase differents systems, differents performances Liquid Q.Líquida System versus versus Dry Q.Seca System Always trying to solve this kind of situations... [ ] da amostra (ukat/l) Química Líquida Química Seca Nº de Ensaios KAPPA and LAMBDA Chains 2 differents calibrators - Europe versus USA One Laboratory / Hemoglobin A1c 2 differents calibrators (DCCT versus IFCC) 2 differents results Actual challenge in the word-wide Traceability on primary system of measuring to the Reference Method and Reference Material Good Accuracy Ex: Potassium differents calibrators, good results. 9

10 Our contribution Today the big fight... the new units of HbA1c 1. PNAEQ WORKING GROUP OF IFCC EQAS Organizers 2. Invitation to represent Portugal HbA1c Working Group "Insulin pumps" of the Steering Committee for National Control of DIABETES - representation of INSA and Clinical Laboratories... our contribution Since 2005 In the short term and with the partnership of SPQC... Agree a strategy for the change (which results, which units and what day for this implementation in Portugal), involving all stakeholders (diabetologists, Laboratories, Patient Associations, Manufacturers,...). Our decision INSA SPQC Report in accord with the Consensus Patient XPTO: HbA1c measure HbA1c = 53 mmol/mol (units IFCC) HbA1c = 7.0% (units NGSP) Our strategy Continue to disclose, disclose, disclose,... the clear advantages of this change... right up to the transition concerted internationally and already agreed at national level, as with the EURO

11 PARAMETHERS OF THE STATISTICAL EVALUATION Evaluation of the performance EVALUATION OF THE PERFORMANCE IN PNAEQ a) Mean / Median; b) Standard deviation, Coefficient of Variation or a measure equivalent (RD relative deviation) for a nonparametric distribution; c) Percentils, deviation absolute median or other robust measures Different statistical treatment PARTICIPANTS LABORATORIES REPORTS some examples Clinical Chemistry - General LABORATORIES EXPERT Mean/Median = Target Value Standard Deviation Clinical Chemistry - Enzimes CONSENSUS VALUE METHOD Mean/Median Standard Deviation Z- SCORE Through global graphics of the performance, the possibility to find the quality of the result of each laboratory for: 2 different levels of the same analite Random Errors Systematic Errors CONSENSUS VALUE Results OK! SEDIMENTATION RATE (Manual and Authomatized Method) 11

12 ENDOCRINOLOGY (QUANTITATIVE / QUALITATIVE) MICOBACTERIOLOGY MICROSCOPY Analysis of the results Expert Laboratory Organiser sends samples (smear) to participants; Participants stains sample according to their procedures & return it to the organiser; Organiser assesses the quality of the staining and Samples with target values the answer. MORPHOLOGY OF PERYPHERICAL BLOOD Analysis of the results Expert Laboratories) Performance evaluation & result reports Laboratory Organizer (2008) Data pretreatment (e.g. visual inspection, outlier test) Average, measure of spread for all data or sub-groups often consensus values Graphics and /or text comments Easy viewing of performance of all parameters of the essay Performance OK! ACCREDITATION ISO/IEC ISO15189 EVALUATION OF PERFORMANCEOF THE LABORATORY Evaluation: Evolution of z-scores in each analytical parameter (-3 Z-Score 3) Correctives actions implemented. ACCREDITATION mandatory participation in EQA s 12

13 Participant consistently performing well Determination of the TOTAL ERROR True value Mean value EQA - Sistematic Error IQC Aleatory errror (Bias) (s) Quality Specifications Tables At the end of each YEAR... OTHER ADVANTAGES... Participation in European Projects (Metrology in Clinical Analyses) But we have done more Seminars, Simposiums, Training and support Harmonization of the results Promotion of improved / new methods and calibration materials (Alfa 1 Globulin -> Method Capillary Electrophoresis versus Gel Migration Methods). Nota: It's called your attention to the determination of alpha 1 globulin. The target value found by the participants who used the method 721 (Capillary Electrophoresis) is about 2-3 times higher than for the traditional methods of electrophoresis (eg agarose gel). This difference is explained by the high proportion of sialic acid that orosomucoid.... While in capillary electrophoresis in UV absorption is not affected by these sugars. Bibliography in Annex: Didier le Carrer, Kalyane Bach-Ngohou, «L électrophorése capillaire automatisée en biologie clinique». Spectra Biologie nº146, Junho 2005, 47-52). PNAEQ/CLINICAL CHEMISTRY Report Assay 153_07 Protein Electrophoresys Globulin α1 LDH Substrate Piruvate to Lactate (Assay 5/09 86 labs) Support SFQC and SAQC ph optimal conversion: LDH Substrate Lactate to Piruvate (Assay 5/09 46 labs) Support of IFCC ph optimal conversion:

14 Não registo de picada acidental Amostra não refrigerada Colheita sem uso de luvas Material de colheita fora do prazo Omissão do registo de dados clínicos Não indicação da hora de colheita Identificação incorrecta Falta de colheita Insuficiente quantidade de amostra 1ª Má prática de colheita Colheita incorrecta de amostra 1ª Colheita s/ confirmação das condições Training and support Continuing Education Parasitology - new parasites (eg. Anisakis sp and 53 labs have agreed, not know) Virology (eg partic. INSA EQA / WHO in 2009 for diagnosis of H1N1 virus) Mycobacteriology - reconfirming / validation of the results received. Assay nº 40P (Parasite morphology) Year 2007 A major objective of these tests - Training Parasite / stage of the known sample under analysis Target result INSA -» Laboratories Sending slides Laboratories -» INSA Resending the slides to INSA PREVENTING PROBLEMS Nº RELATED lâmina QUALITY OF THE SAMPLE / BLADE RECEIVED BAD COLORING HETEROGENEITY OF SAMPLE REANALYSIS / VALIDATING THE RESULT. Previsto PNAEQ Micobacteriology Resultado Lab. participant e (1) FNB- False Negative Low (1) FNA - False Negative High Reavaliado Tipo de erro Score Correcto 10 2 Negativo Negativo Correcto Negativo 1-9/100 campos FNB Correcto 10 5 Negativo Negativo Correcto 10 6 Negativo Negativo Correcto Negativo 1+ FNA 0 8 Negativo Negativo Correcto Correcto Correcto 10 Training and support Orienting to factors that affect quality, such as eg human error, interference,... Trials of Pre and Post-Analytical phase. PRE-ANALITICAL PHASE - Essay 2/ 2007 POST-ANALITICAL PHASE - Essay 2/ 2007 Laboratório central % de erros - Acto da Colheita Falta de colheita para o pedido solicitado/ amostra não colhida Identificação incorrecta Não indicação da hora de colheita Omissão do registo dos medicamentos em uso, dados do ciclo menstrual, dados clínicos Colheita efectuada sem utilização de luvas LOW MEMBERSHIP IN THE FACE OF THE IMPORTANCE OF THESE TESTS! Lack of implementation and monitoring of quality indicators! Transmissão inadequada equip/ SI e SI/ impressão Valores de ref erência inadequados Método mal identif icado Inadequada indicação da unidade de medição Não envio de resultados de exames solicitados Resultados de exames não solicitados Laboratório Central - Frequencias - Pós-exame Diagrama de Frequencias - Consequencias - Acto de Colheita Resposta s/ id do laboratór io Resposta com nome er rado LARGEST MEMBERSHIP OF ACCREDITATED AND CERTIFIED LABORATORIES Sem Moderada Grave Resultados sem conf ir mação da id Resultados em envelope não f echado Sem Moderada Grave 14

15 Training and support One Laboratory/ Hemoglobin A1c 2 differents calibrators (DCCT versus IFCC) 2 differents results Promoting the use of calibrators and best practices examples: Enzymes - units at 37ºC; HbA1C - DCCT method with IFCC calibration. Current world bet Traceability of the measuring system to the Reference Method and Reference Material Good Accuracy Ex: Potassium differents calibrators, similar results. Training and support Recommendations PNAEQ HbA1c (1ª Assay 2006) It is advisable for all national clinical laboratories: - Using the DCCT calibration; - Do not change yet the result in accordance with IFCC calibration. Our contribution 1. PNAEQ WORKING GROUP OF IFCC EQAS Organizers 2. Invitation to represent Portugal subject HbA1c Medium-term bet on the implementation of methods traceable to the IFCC reference method for hemoglobin A1C (symposia / workshops for laboratory staff, general practitioners and diabetologists). Working Subgroup Insuline Pumps" of the Comission of Coordenation of the National Program of DIABETESControl - representing INSA / Clinical Laboratories. Training and support Recommendations Indication of literature (eg, tables with the EMA), recommendations for internal quality control, including the pre and post-analytical and other recommendations to improve the quality of service provided by laboratories. 15

16 PNAEQ WATER MICROBIOLOGY PNAEQ ENVIRONMENT AREA This scheme started in 1996 called EQUASE /Extend Quality Assurance in Water Microbiology to Cohesion Countries A project with the support of European Funds Cooperation and the Health Protection Agency. PNAEQ FOOD MICROBIOLOGY This one has started at year 2001, Objective evaluate the performance of labs in INTERNET ACCESS MICROBIOLOGIC ESSAYS in cooperation with FOOD EQA - HPA/Health Protection Agency PNAEQ the new software Using Internet will be possible: To inscribe in schemes; To introduce the results; To visualize the reports; PNAEQ RECOGNIZING THE IMPORTANCE OF NEW AREAS... E-learning,. 16

17 Quality in the circuit of laboratory activities Sample Colheita collection Amostra EQA Sample Transportation From 2006: NEW AREAS IN PNAEQ Requisição Request for da(s) examination(s) análise(s) PRE AND POST ANALYTICAL PHASES Clinician Processin g Sample From 2009: Information Patient Patient Action Reporting Relatório of results resultados Preanalytical phase Pre - Analytical Analítica Analíticaphase Postanalytical - Analítica Processamento phase Processing results Resultados Analysing Sample MICOBACTERIOLOGY TSA From 2010: SAFETY, After 2000 PNAEQ AIR MICROBIOLOGY This scheme has started in SEPTEMBER 2010, Our major objectives for 2010 Objective evaluation of the performance of labs in MICROBIOLOGIC ESSAYS OF THE AIR. MORE AND BETTER SERVICE Increasing participation in new and differents programs / areas in Portugal (e.g: Microbiology of the Air, H1N1, ), and extending to other Continents, (EQAs, training by e-learning platform) preferably to the Portuguese Comunity of Portuguese Language, e.g: Angola, Cabo Verde, Moçambique, S. Tomé, Brasil, some ongoing. TO EXPAND THE SCOPE OF PNAEQ TO POCT S New schemes of External Quality Assessment to evaluate the quality of the results obtained with Point of Care equipments ex: glicose, cholesterol, allowing an retrospectively assessment. 17

18 The Annual Meeting of Members for discussion of EQA s common problems today on a global level. Last meetings EQALM Barcelona (Spain) 2003 Viena (Austria) 2004 Roma (Italy) Genebre (Switzerland) Amesterdam (Neitherlands) Birmingham (RU) Berlim (Germany) 2009 e 2010? EQALM in collaboration with PNAEQ / EQAS Portuguese LISBON /Portugal October 2010 The national experience (32 years) contributes to the invitation by WHO to PNAEQ to go to the National Institute of Health in Ankara/Turkey (October 2009) to advise the principal points on the implementation of a National EQA Scheme. Continuation in 2010? HbA1c change of units in the short term Our big big objective A big bet of INSA in 2010 In cooperation with the SPQC (Portuguese Society of Clinical Chemistry), to agree on a plan for changing the Units (which and when) involving all stakeholders. Medical Doctors Patients Associations Medical Laboratories Suppliers, THE ACCREDITATION OF OUR PROGRAM Standard ISO / IEC (Conformity assessment - General requirements for proficiency testing),... Still in the approval stage ( ). In sequence of a Conference organized by THE RECOGNITION OF THE IMPORTANCE OF THE EQA SCHEMES, ON A GLOBAL LEVEL WHO/CDC who held in April Lyon/France attended by 69 countries (PORTUGAL), THE POSITION OF WHO WAS TO 18

19 Development of ISO WHO - CONFERENCE ON LABORATORY QUALITY SYSTEMS IN THE 21ST CENTURY (2008) It is recommended that countries with limited ressources consider taking a staged approach, where principal requirements are given in the national laboratory standards as a minimum obligation while more advanced laboratories are encouraged to aim at meeting international standards (such as ISO 15189) as a preferred option. Alemanha Argentina Austria Australia Bélgica Brasil Canada Chile China Coreia Dinamarca Espanha Estados Unidos Finlandia Franca Holanda Irao Irlanda Israel Italia Jamaica Japão Mexico Nova Zelândia Noruega Portugal Reino Unido Republica Checa Singapura Suecia Suiça Turkey Quality ISO Management 9001:2000 Systems ISO 17025:1999 ISO 15189:2003 General requirements for the competence of testing and Medical Laboratories calibration laboratories Requirements for quality and competence Recommendation Develop national resources to ensure the internal quality control and external quality assessment Outcomes of the satisfatories results in EQAS GOOD results in EQA Joint statement by WHO-CDC: conference on laboratory quality systems in the 21st century Lyon, April 2008 Evidence that the analytical procedures are under control Guarantee of security to the colaborators of the laboratory Evidence of uniformity ad comparability of your results with others laboratories Sir Winston Churchill (1942) I - THE LAB. IN A CHIP -> Nanotechnology This is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning. 19

20 REFERENCES II - LABORATORY IN A CHIP -> Nanotecnology My new mobile? No. My new laboratory! To analyser DNA it s easier, quick and cheap Soon New strategies of evaluation of Quality of the result will have to arise! Joint WHO CDC Conference on Health Laboratory Quality Systems (WHO ); ISO/IEC Conformity Assessment General requirements for proficiency testing (CASCO ) (in revision); VIM Guide ISO/IEC 99:2007; The First International Proficiency Testing Conference, Sinaia, România (2007); ISO 15189:2007 standard Clinical laboratory testing and in vitro diagnostic systems; ISO 13528:2006 Statistical methods for use in proficiency testing by interlaboratory comparisons; Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures (pren CEN/TC ); Regional Intercountry Workshop on Quality Assurance in Laboratory Medicine WHO (WHO-EM/LAB/294/E/L 1998); European Conference of External Quality Assessment Organizers ECEQAO ( ). PNAEQ / National Institute of Health Dr. Ricardo Jorge (INSA) Lisbon, PORTUGAL Thank you very much. Probably the last opportunity to speak to you all. Questions???? 20