development of laboratory medicine in europe

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Laboratory medicine Laboratory medicine disciplinary branch of medicine providing the healt em with laboratory results....(R.Dybkaer) al laboratory 5189, 3.8: atory for the biological, microbiological, immunolo cal, immunohaematological, biophysical, cytological logical, or other examination of materials derived uman body....

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Page 1: Development of Laboratory Medicine in Europe

Laboratory medicineLaboratory medicine

Multidisciplinary branch of medicine providing the health care system with laboratory results....(R.Dybkaer)

Medical laboratoryISO 15189, 3.8:laboratory for the biological, microbiological, immunological,chemical, immunohaematological, biophysical, cytological, pathological, or other examination of materials derived from the human body....

Page 2: Development of Laboratory Medicine in Europe

Future trends and challengesFuture trends and challenges

1. Financial limitations forces concentration of resources2. Overlapping techniques also require laboratories

"without walls"3. Genomics, transcriptomics, proteonomics, metabolomics4. Professional expertise5. Improvement of quality of service and of consultation

in the sense of TDM6. POCT engagement of central laboratories7. Justification of laboratory medicine as a discipline

Page 3: Development of Laboratory Medicine in Europe

Competence centre for LMCompetence centre for LM

1.Step: integration of clinical microbiology in the centrallaboratory = Institute for Laboratory Medicine

2.Step: Private limited liability company(community 49 %, private group 51 %)

3.Step: Concentration of several disciplines in onebuilding (laboratory medicine, blood bank, hygiene, human genetics, etc.)

4.Step: Further consolidation towards one organisational unit (?)

Page 4: Development of Laboratory Medicine in Europe

Benefits of concentrationBenefits of concentration

-broaden financial resources

-eliminate dual financial system

-focussing competence (more specialists)

-providing more efficient regional patient care

Page 5: Development of Laboratory Medicine in Europe

Future trends and challengesFuture trends and challenges

1. Financial limitations forces concentration of resources

2. Overlapping techniques also require laboratories "without walls"

3. Genomics, transcriptomics, proteonomics, metabolomics4. Professional expertise5. Improvement of quality of service and of consultation

in the sense of TDM6. POCT engagement of central laboratories7. Justification of laboratory medicine as a discipline

Page 6: Development of Laboratory Medicine in Europe

Future trends and challengesFuture trends and challenges

1. Financial limitations forces concentration of resources2. Overlapping techniques also require laboratories

" without walls"3. Genomics, transcriptomics, proteonomics,

metabolomics4. Professional expertise5. Improvement of quality of service and of consultation

in the sense of TDM6. POCT engagement of central laboratories7. Justification of laboratory medicine as a discipline

Page 7: Development of Laboratory Medicine in Europe

Future trends and challengesFuture trends and challenges

3. Genomics, transcriptomics, proteonomics, metabolomics- traditional genetic diseases (CAH)- gene expression in oncology (cancer diagnosis)- tailored pharmacotherapy (TDM)- infectious diseases

Page 8: Development of Laboratory Medicine in Europe

breast cancerbreast cancer

7 – 10 % herediterally determined

80 % due to BRCA 1 and 2

80 % of BRCA 1 carriers develop breast cancerUp to the age of 70

Page 9: Development of Laboratory Medicine in Europe

Future trends and challengesFuture trends and challenges

3. Genomics, transcriptomics, proteonomics, Metabolomics

- traditional genetic diseases (CAH)- gene expression in oncology (cancer diagnosis)

- tailored pharmacotherapy (TDM)- infectious diseases

Page 10: Development of Laboratory Medicine in Europe

Future trends and challengesFuture trends and challenges

3. Genomics, transcriptomics, proteonomics, Metabolomics

- traditional genetic diseases (CAH)- gene expression in oncology (cancer diagnosis)- tailored pharmacotherapy (TDM)

- infectious diseases

Page 11: Development of Laboratory Medicine in Europe

Trend to miniaturization in laboratory medicineTrend to miniaturization in laboratory medicine

Floor standingbench top

portablehandhold

microchipnanochip

Page 12: Development of Laboratory Medicine in Europe

Future trends and challengesFuture trends and challenges

1. Financial limitations forces concentration of resources2. Overlapping techniques also require laboratories

"without walls"3. Genomics, transcriptomics, proteonomics, metabolomics

4. Professional expertise5. Improvement of quality of service and of consultation

in the sense of TDM6. POCT engagement of central laboratories7. Justification of laboratory medicine as a discipline

Page 13: Development of Laboratory Medicine in Europe
Page 14: Development of Laboratory Medicine in Europe

Future trends and challengesFuture trends and challenges

1. Financial limitations forces concentration of resources2. Overlapping techniques also require laboratories

"without walls"3. Genomics, transcriptomics, proteonomics, metabolomics4. Professional expertise

5. Improvement of quality of service and of consultation in the sense of TDM

6. POCT engagement of central laboratories7. Justification of laboratory medicine as a discipline

Page 15: Development of Laboratory Medicine in Europe
Page 16: Development of Laboratory Medicine in Europe

blood glucose (mg / dl)reference intervals (textbooks) decision limits (WHO)

type 2 DM IGTVP0 70 – 115 126 110VP2h 200 140VB0 60 – 100 110 100VBa,0 135 118VB2h 180 120VBa,2h 194 150

CP0 126 110CP2h 220 140CB0 70 – 100 110 100CB2h 200 140CBa,0 135 118CBa,2h 237 150

Page 17: Development of Laboratory Medicine in Europe

Future trends and challengesFuture trends and challenges

1. Financial limitations forces concentration of resources2. Overlapping techniques also require laboratories

"without walls"3. Genomics, transcriptomics, proteonomics, metabolomics4. Professional expertise5. Improvement of quality of service and of consultation

in the sense of TDM

6. POCT engagement of central laboratories7. Justification of laboratory medicine as a discipline

Page 18: Development of Laboratory Medicine in Europe

Strategies of central laboratories for engagement in POCTStrategies of central laboratories for engagement in POCT

1. The top management should decide on the responsibilities

2. Installation of a POCT commission chaired by the laboratory director(selection and justification of POCTinstruments, quality assurance program,comparability of results with laboratory results)

3. Nomination of a POCT coordinator

4. On-line network between laboratory and POCT stations

Page 19: Development of Laboratory Medicine in Europe

Indications for POCT glucoseIndications for POCT glucose

1. at least 5 tests per week

2. insulin therapy

3. suspicion for hypoglycemia

4. training of patients

not for diagnosing type 2 DM or glucose intolerance

Page 20: Development of Laboratory Medicine in Europe

Future trends and challengesFuture trends and challenges

1. Financial limitations forces concentration of resources2. Overlapping techniques also require laboratories

"without walls"3. Genomics, transcriptomics, proteonomics, metabolomics4. Professional expertise5. Improvement of quality of service and of consultation

in the sense of TDM6. POCT engagement of central laboratories

7. Justification of laboratory medicine as a discipline

Page 21: Development of Laboratory Medicine in Europe

Evaluation of method comparisonsEvaluation of method comparisons

1.Step1.Step

definition of the analytical comparability definition of the analytical comparability

(conventual concept)(conventual concept)

2.Step2.Stepdetermination of the diagnostic relevance determination of the diagnostic relevance (future concept)(future concept)

Page 22: Development of Laboratory Medicine in Europe

SummarySummary1. Vision: same quality and comparable results in Europe by

means of harmonisation of methods, of reference intervals,development of decision limits and the sameaccreditation system. ELM tries to support these goals.

2. all disciplines must come under one roof or on one platform in so-called competence centres which should be organized on a regional basis servicing a population of 0.5 to 1.0 million people. If the region is spread, especially in rural areas, satellite laboratories may be required. Several competence centres can co-operate for special expertise.