Laboratory management:

 Principles and evidence based of laboratory medicine:

 Evidence based laboratory medicine:
- How to assesses the diagnostic accuracy.
- How used clinical outcome studies.
- Ways to evaluate the economic values medical test.
- How to conducts systemic review of diagnostic test.
- What and how to conduct a clinical audit.
 What is laboratory medicine ?
- Is disciplines involved selection, provisions and interpretation of diagnostic testing
using sample from patients.
- Testing laboratory can be.
A confronting a clinical diagnostic.
B) excluding the diagnostic.
c) Assisting in selection and monitoring the treatment.
d) providing prognosis.
e) screening the disease.

 Practice of evidence based of laboratory medicine:

- Knowledge of clinical process and conversion of clinical goal into answerable
question.
- Facility to generate and critically appraise information to generate knowledge.
- Ability to knowledge resources.
- Accessing and delivering .
- Framework of clinical and economic accountability.
- Framework of quality management.
 Types of diagnostic question to ask in laboratory.
 In the descious making types of questions need to be ask.
-1) what is the diagnosis.
2) can another diagnosis rules out .
3) what is patients prognosis.
4) How is the patients doing.

 Information needs in evidence based laboratory medicine.

 Evidence based of laboratory medicine have five major goals .
- Diagnostic accuracy.
- Determination of value of testing ( outcome )
- Systemic reviewing of the studies of diagnostic accuracy.
- Economic evaluation of test determinates which test to be used.
- Audited performances of test.
 Study design:
- Study of diagnostic accuracy ( results of test) is test of interest.
- References standard is available method for establishing of presence or absence
target conditions ( suspended diseases ).
- References standard can be single test or combination of method and techniques.
 Point of testing care.
- Is test mode in which the analysis is preformed at sit of the patients.
 - Other term.
- Bid side
- Near the patients.
- Physician office.
- Extra laboratory.
- Decentralized.
- Off site .
- Alternative site .
- Unite using for testing.
 Environment where POCT is needed.
 Primary care .
- Home, community pharmacist, health center.
- Workplace clinic.
- Physician or community clinic.
- Diagnostic and treatment center.
 Secondary and tertiary care.
- Emergency room.
- Admission unite.
- Operations room .
- Intensive care unite and ward.
- Outpatient clinic.
 Advantage poct:
- Reduced turn around time (tat) of test result.
- Improved patients management.
- Reduction of administives work.
- Minimize delay during the sample collection.
- Reduced in time delay in sample transportation to the testing lab.
- Reduction in the time delay sample registration.
 Characteristic requirements of POCT analyzer.
- First results in minutes or less.
- Portable instruments with consumable reagent cartilage.
- One or two step operating protocol.
- Capabilities of preforming direct specimens analysis on whole blood and urine .
- sample operating procedures do not required trained laboratory personal.
- Flexible test menus.
- Low instrument cost.
 Types of POCT testing instruments or devices.
- Single pad qualitative strip or cartilage and/ or strip devices:
- Including
- Singles pad urine test (dipstick) ready visually .
- More complexes strip use light reflectance for measurement.
- Fabricated cassettes or cartilage that incorporate techniques are
immunochromatography are used as immunosensor .
- Others application:
- Are immunosensor device capable of measuring panel analyte e.g cardiac marker,
allergy test, facility test, drug abuse also single sensor are use for thin film.
 Implementation and management consideration.
- POCT in health facility required necessary planning, oversight and inventory control.
 - Establishment of need.
- POCT services required:
- Establishments need.
- Consideration of clinical, operations and economic benefits.
- Examination of the cost and changes in the clinical process.
 Factors that need to be considered when implementing, management and maintenance
POCT services.
- Organizing and implementing of a coordinating committee:
- Establishing a POCT testing policy and accountability.
- Procuring equipments and its evaluation.
- Training and certificate of operations.
- Establishing QA, assurance and adult policy.
- Ensuring documentation.
- Establishing an accreditation and regulations of POCT policy.
 Equipments procurement and evaluation.
- The process of equipment and procurement first identifying.
- Candidate POCT prerequisite analytical and operational capabilities to meet clinical
requirements.
- Element of point testing care policy.
- Catalog information reviews.
- Approved by.
- Original distribution.
- Related policy.
- Further information.
- Policy replaces.
 Management of POCT committee and accountability:
- Officer
- Committee members.
- Terms of references.
- Responsibility.
- Meeting .
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