1、Chapter 1 General of Clinical LaboratoryLI PingGeneral of clinical laboratoryPrinciples to clinical laboratory The interpretation of laboratory testsThe ethical practicePrinciple to clinical laboratory ResponsibilitiesCollection of Information Collection of Specimens (Informed consent、Adequate priva
2、cy)Performance of Test Reporting of Result Storage and Retention of Medical RecordsAccess to Medical RecordsResponsibilities The patient-assurance the quality and integrality of the service Colleague and professional-maintain professional reputation,aim to contribute the advancement of profession So
3、ciety-contribute to the general well-being of society;#comply with relevant laws and regulations of professional activities.Collection of information Identify adequately patients and specimens Enable the test to be correctly interpreted Other legitimate purposes Performance of the testAccreditation
4、programPatients interestsProcess standard Works with high skill and competence Good performance of tests Reporting of Result Test results are confidential unless disclosure is authorized.Report the results correctly and timelyProvide the consultation about the selection and interpretation of tests p
5、roperly Access to Medical Recordsclinician requesting the test;#the patient;#laboratory and hospital staff if required for the management of the patient;#other authorized individuals.When a request is made for access to test results by an authorized person,the laboratory must first satisfy itself as
6、 to the identity of the person making the request.Who?#INTERPRET LABORATORY TEST Select test Patients prepare for sampling Collect specimen Pre-process of specimen Analyze specimen Check、report result Make clinical decisionBiological variability,improper or inconsistent preparation Improper or incon
7、sistant Collection Improper provision suboptimum selection Analytical variabilty Inadequate RVs Minimize variability No confusion and misunderstanding about test results Testing CycleBiologic variatinon Endogenous biorhythms for physiologic parameters Different constitutional factors and lifestyle a
8、mong subjects within-subject variation subject-to subject variation Biological variation Width of the tests Referenc interval(RI)the diagnostic efficiency of a laboratory test lBiological rhythmslConstitutional factors lExtrinsic factorsThree types of Biological rhythmsCircadian Rhythms Ultradian Rh
9、ythms Infradian Rhythms Cycle time 24h 24h Character Consistent Predictable Inconsistent Unpredictableunknowsolutionrhythm-adjusted RVs stimulation and suppression testsunknowexampleNumber and activity of blood cellgonadal hormonemenstrual cycle Biologic variation endogenous biorhythms for physiolog
10、ic parameters Different constitutional factors and lifestyle among subjects within-subject variation subject-to subject variation Biological variation Width of the tests Referenc interval(RI)the diagnostic efficiency of a laboratory test lBiological rhythmslConstitutional factors lExtrinsic factorsB
11、iologic variabilty Constitutional factorinfants children adults elderly rapid physiologic changes 、hemolysis、bilirubin Plasma protein enzyme sex hormones constant until menopause in women and middle age in men age-related differences in nutrition、intercurrent disease Agespecific reference limits age
12、Age Biologic variabilty Constitutional factorGenetic heterogeneity phenotypic differences Different concentration of analyte Different reactivity towards nucleic acid probes and antibodies false-negative Misleading Genetic heterogeneityBiologic variabilty-Extrinsic Factorsvascular interstitial space
13、 supine stand H2OSmall analyte plasma volumeConcentration of nondiffusibl analyte homeostasis of vascular tone rennin aldosterone catecholamines Posture Biologic variabilty Extrinsic Factorsshifts in plasma waterglomerular filtration rate urine productionrelease of macromolecules from cells and tiss
14、ues Exercise Biologic variabilty-Extrinsic Factors meal related fasting relatedl Recommendation:#duration of fasting before specimen collection is typically 12 hoursTGTCBUNGLU.LacAcetone Glucagons.Diet Biologic variabilty Extrinsic Factors Types of Interference Analytical interference Physiologic in
15、terferenceRecommendation Recognize drugs potential for occurrence,withdraw medications before sampling whenever possible,Evaluat any suspicious results in light of a subjects medication history.Drug Biologic variabilty-Extrinsic Factorsplasma volume erythrocyte mass plasma protein synthesis altered
16、distribution of cardiac output endocrinologic changes hyperventilation PregnancyBiologic variation-summary Biological rhythms Circadian,Ultradian,Infradian rhythmsConstitutinal factors Gender,age,geneExtrinsic factors Posture,Exercise,Diet,Drugs,Pregnancy,Caffeine,Alcohol use,Oral Contraceptives,Intercurrent IllnessEstablish and validate RVsEstablish clinical performance characteristics Why?#lHelp clinician to select the most effective tests and testing strategies lHelp clinician to translate laborator
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