30/09
1-Diagnostic Regulation
Laboratory medicine provides the foundation for safe, effective and equitable healthcare
delivery, population health and global health security. Rule of laboratory medicine: into all the
clinical diagnoses and helpful for patient health care. There are different areas of information
that have to be obtained from the patient such as clinical knowledge and past experience,
medical imaging, pathology and laboratory medicine and other diagnostic testing all of which
provide information that will be required to reach a diagnostic, initiate treatment and
discharge the patient.
More modern definition of laboratory medicine: is a clinical science that has to quantify
measurements and give them in a qualitative way as well. The results have to be translated
into actionable information helping to improve the patient's care. Not only related to the
analytical methods used in the laboratory for measurements but also translation of these
measurements to actionable information to improve the care of individuals and populations
from anticipation of a diagnosis to admission and to discharge. The laboratory and the
clinical measurements of all the analytes have the same importance as the emergency
services, the prescription of drugs, pediatric services etc.
In vitro diagnostic (IVD) testing: what is done in clinical laboratories. IVD does not receive
as much funding as other areas. IVD testing guides approx 65% of clinical decisions.
Physicians overrate the costs of IVD as a proportion of HCE (health care expenses).
Modern laboratory medicines:
Test related:
- Proteomics/Biomics/-omics
- Biomarkers for early diagnosis
- Risk factors for disease preventions
- Real-time results
- More effective tests (strongly influencing the clinical decision making)
Ex. Cardiac Troponins → measured for acute coronary syndrome shortly after admission.
Ex. Anti-Transglutaminase Ab → Measure for celiac disease.
The diagnostic process:
1. Patient experiences and health problem
2. Patient engages with health care system
3. Information integration and interpretation
4. Communication of the diagnosi
5. Treatment
6. Outcomes
,Diagnostic testing: is done for screening, risk stratification, reaching diagnosis, treatment
selection and monitoring disorders. Done to improve the outcomes which are:
- Patient safety
- Economic gains, giving the patient the correct diagnosis can help this person to
return to work faster.
- Physical and medical patient health, a patient with different symptoms but not related
to a specific disease makes it hard to get a diagnosis without screening testing or
without a proper genetic test and can help the patients get their diagnosis.
- Social and community gains
- Empowerment
Laboratory testing: VALUE: the net value of the testing process is defined as delivered
benefits minus delivered harm (undesirable effects of testing).
Clin Chem - journal of clinical chemistry.
In clinical microbiology there have been significant advances in the time that results take to
be obtained.
Molecular test growth: molecular diagnostics is unique for each specialty (oncology,
genetic, infectious disease).
GRAPH: Red: validated tests, blue: test performed. The difference is because there are a lot
of tests that are performed but the validated test (can help get a diagnosis) are low in
infectious disease while the validated tests are more in genetics and oncology. In oncology
the number of different tests parallels infectious disease. Oncology test volume is low but
exponential, suggesting the most rapid growth rate.
Cost per genome: using DNA is cheaper → Next generation sequencing (NGS) is very
useful.
,Different types of services in a laboratory medicine lab:
- Clinical biochemistry
- Cytopathology
- Hematology and hematopathology
- Histopathology
- Immunopathology
- Medical microbiology
- Laboratory informatics
- Transfusion medicine
- Pediatric and perinatal pathology
- Molecular pathology and genetics
- Forensic pathology
Technological advances lead to integrated diagnostics:
How to improve:
- Diagnostic errors: are significant and underrepresented. Diagnostic errors
definition: Failure to establish an accurate and timely explanation to the patient’s
health problem or failing to communicate the explanation to the patient.
, Total testing process: overall process leading to the production of useful information for
patient care based on measurements starting from biological materials such as blood.
1. Pre-pre analytical phase
2. Pre-analytical phase (ex. how to collect transport and prepare the samples, ex. there
are different vials for different tests such as with anticoagulant/EDTA)
3. Analytics: samples analysis
4. Post analytical phase
5. Post-post analytical phase
Brain-to brain loop: highlights how the request of each lab test needs both the lab brain
and also the clinician brain. Lack of direct patient’s involvement. Now the patient is more
involved in the final part of the loop. The patient is increasingly informed and interested in
knowing the various aspects of the laboratory test, the usefulness of the test in providing
answers to his or her health problems and the problems related to the cost.
Duties of medical laboratory:
1. Guarantee quality of the tests: work in a safe and good way.
2. Improve the quality of services (total quality management)
3. Improve medical outcomes to maximize the impact of laboratory information on
patient management.
4. Joint laboratory/clinical research projects to ensure the adequate introduction of new
insights in clinical practice.
1-Diagnostic Regulation
Laboratory medicine provides the foundation for safe, effective and equitable healthcare
delivery, population health and global health security. Rule of laboratory medicine: into all the
clinical diagnoses and helpful for patient health care. There are different areas of information
that have to be obtained from the patient such as clinical knowledge and past experience,
medical imaging, pathology and laboratory medicine and other diagnostic testing all of which
provide information that will be required to reach a diagnostic, initiate treatment and
discharge the patient.
More modern definition of laboratory medicine: is a clinical science that has to quantify
measurements and give them in a qualitative way as well. The results have to be translated
into actionable information helping to improve the patient's care. Not only related to the
analytical methods used in the laboratory for measurements but also translation of these
measurements to actionable information to improve the care of individuals and populations
from anticipation of a diagnosis to admission and to discharge. The laboratory and the
clinical measurements of all the analytes have the same importance as the emergency
services, the prescription of drugs, pediatric services etc.
In vitro diagnostic (IVD) testing: what is done in clinical laboratories. IVD does not receive
as much funding as other areas. IVD testing guides approx 65% of clinical decisions.
Physicians overrate the costs of IVD as a proportion of HCE (health care expenses).
Modern laboratory medicines:
Test related:
- Proteomics/Biomics/-omics
- Biomarkers for early diagnosis
- Risk factors for disease preventions
- Real-time results
- More effective tests (strongly influencing the clinical decision making)
Ex. Cardiac Troponins → measured for acute coronary syndrome shortly after admission.
Ex. Anti-Transglutaminase Ab → Measure for celiac disease.
The diagnostic process:
1. Patient experiences and health problem
2. Patient engages with health care system
3. Information integration and interpretation
4. Communication of the diagnosi
5. Treatment
6. Outcomes
,Diagnostic testing: is done for screening, risk stratification, reaching diagnosis, treatment
selection and monitoring disorders. Done to improve the outcomes which are:
- Patient safety
- Economic gains, giving the patient the correct diagnosis can help this person to
return to work faster.
- Physical and medical patient health, a patient with different symptoms but not related
to a specific disease makes it hard to get a diagnosis without screening testing or
without a proper genetic test and can help the patients get their diagnosis.
- Social and community gains
- Empowerment
Laboratory testing: VALUE: the net value of the testing process is defined as delivered
benefits minus delivered harm (undesirable effects of testing).
Clin Chem - journal of clinical chemistry.
In clinical microbiology there have been significant advances in the time that results take to
be obtained.
Molecular test growth: molecular diagnostics is unique for each specialty (oncology,
genetic, infectious disease).
GRAPH: Red: validated tests, blue: test performed. The difference is because there are a lot
of tests that are performed but the validated test (can help get a diagnosis) are low in
infectious disease while the validated tests are more in genetics and oncology. In oncology
the number of different tests parallels infectious disease. Oncology test volume is low but
exponential, suggesting the most rapid growth rate.
Cost per genome: using DNA is cheaper → Next generation sequencing (NGS) is very
useful.
,Different types of services in a laboratory medicine lab:
- Clinical biochemistry
- Cytopathology
- Hematology and hematopathology
- Histopathology
- Immunopathology
- Medical microbiology
- Laboratory informatics
- Transfusion medicine
- Pediatric and perinatal pathology
- Molecular pathology and genetics
- Forensic pathology
Technological advances lead to integrated diagnostics:
How to improve:
- Diagnostic errors: are significant and underrepresented. Diagnostic errors
definition: Failure to establish an accurate and timely explanation to the patient’s
health problem or failing to communicate the explanation to the patient.
, Total testing process: overall process leading to the production of useful information for
patient care based on measurements starting from biological materials such as blood.
1. Pre-pre analytical phase
2. Pre-analytical phase (ex. how to collect transport and prepare the samples, ex. there
are different vials for different tests such as with anticoagulant/EDTA)
3. Analytics: samples analysis
4. Post analytical phase
5. Post-post analytical phase
Brain-to brain loop: highlights how the request of each lab test needs both the lab brain
and also the clinician brain. Lack of direct patient’s involvement. Now the patient is more
involved in the final part of the loop. The patient is increasingly informed and interested in
knowing the various aspects of the laboratory test, the usefulness of the test in providing
answers to his or her health problems and the problems related to the cost.
Duties of medical laboratory:
1. Guarantee quality of the tests: work in a safe and good way.
2. Improve the quality of services (total quality management)
3. Improve medical outcomes to maximize the impact of laboratory information on
patient management.
4. Joint laboratory/clinical research projects to ensure the adequate introduction of new
insights in clinical practice.
