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Introduction To Clinical Laboratory

List 7 Lab Departments or Divisions Lab Departments or Divisions Hematology Hemostasis (Coagulation) Urinalysis Clinical Chemistry (Biochemistry) Blood Bank (Immunohematology, Transfusion Services) Immunology and Serology Molecular Diagnostics Microbiology
Clinical Laboratory Sciences Professional Team Clinical Laboratory Sciences Professional Team Medical laboratory scientists (MLS) Medical laboratory technicians (MLT) Phlebotomists Medical laboratory aides
Federal Regulatory Standards for Laboratories Federal Regulatory Standards for Laboratories CLIA (quality and proficiency regulations) OSHA (safety regulations) HIPAA (privacy regulations)
Regulatory Agencies (list 4) CAP-certifies proficiency of clinical laboratories FDA-Rates the laboratory Testing OSHA-safety and inspections TJC-The joint Commission (every 2 yrs)
CLIA Clinical Laboratory Improvement Amendments (CLIA'88) 1988 Provides regulations for ALL laboratories All labs must have a CLIA certificate to perform testing and receive federal reimbursement. Includes a certificate fee and biennial inspection fee
Two ways to get CLIA Certified There are two ways to be CLIA certified: Accreditation by Health Care Financing Administration (HCFA) Accreditation by a private organization i.e. TJC,CAP,AAB,ISO APPROVED STATE LAB PROGRAMS
Four Levels of test Complexity Four levels of test complexity Waived testing (doesn't require lab professional status to perform/interpret) PPM - Provider (physician) performed microscopy Moderately complex testing Highly complex testing
Each test is rated as to its level as determined by FDA according to the test complexity and potential risk to public health Risk of harm to the patient Risk of erroneous result Level of personnel training Level of test complexity Knowledge and amount of interpretation required to evaluate test results Availability of test for home use
CLIA/FDA 3 Levels of Complexity 1.Waived (FDA level 1) 2.PPM-Preffered Provider Microscopy (FDA level 1) 3.Moderately complex testing (FDA level 2) 4.Highly complex testing (FDA level 3)
CLIA Regulation Requirement 1.Qualified Personell 2.QC Program 3.Proficiency Testing PT 4.Procedure Manuals 5.Quality Assurance Plans 6.Inspections 7.Medicare Coverage-compliance
OSHA Occupational Safety and Health Administration
OSHA Regulation: (5) 1.Universal Precautions-treat all to be infectious 2.PPE(personnel protective equipment) 3.Universal Precaution Workplace Practices 4.HBV Vaccination Program-for all personnel 5.Annual Inspections
Other OSHA Regulation Other OSHA Lab Regulations 1.Occupational Exposures to Hazardous Chemicals – chemical hygiene plan (CHP) must be put in place 2.Occupational Exposure to Formaldehyde 3.Prevention of the Transmission of Mycobacterium tuberculosis
HIPAA Health Insurance Portability and Accountability Act
HIPAA established in ____ and issued by _____ 1996 and Issued by Dept. of Health and Human Services (HHS)
(OSHA Regulations) 3. Universal Precaution Workplace Practices must include:(7) 1.handwashing 2.no recapping of contaminated needles 3.disposable of sharp objects in sharp containers 4.no food and drink in laboratory 5.no mouth pipetting 6.biohazard and appropriate warning labels and biosafety bags 7.dress code for safety
(OSHA Regulations) 1. Universal Precautions lab personnel must treat all body fluid specimens as if they were infectious
(OSHA Regulations) 2.PPE ...give example gloves lab coats eye protection (mask or face shields)
MLT Medical Laboratory Technician (MLT) Complete training in basic laboratory sciences Entry-level education = an associate degree (AS) Credientials = MLT
MLS Must be educated in the basic sciences (biology, chemistry, physics, etc.), management, and education Complete training in basic laboratory sciences and special testing Entry-level education = BS Formerly CLS or Medical Technologist MT
Regulatory Agencies that certifies the proficiency of clinical laboratories,testing and inspection program CAP
Regulatory Agencies that rates the laboratory testing according to their potential risk to public health FDA
Regulatory Agencies that oversea the safety inspection (schedule or unschedule) (safety regulations) OSHA
Regulatory Agencies that accredits healthcare organizations and programs in the US TJC
LAW that ensure privacy regulation HIPAA
NATIONAL ACCREDITING AGENCY FOR CLS (laboratory education program accreditation) NAACLS
TJC is surveyed inspection every 2 years
CLIA Clinical Laboratory Improvement Amendments
Laboratory could received how many challenge specimens for each analyte (proficiency testing) and how many times a year 3-5 challenge 3 times per year
proficiency testing requirement, labs must score_____and bloodbank must score_____ labs must score 80 % or higher bloodbank must score 100%
Who monitors proficiency testing (pt)> TJC The Joint Commission
FDA Level 1 PPM Preferred Provider Microscopy
FDA Level 2 Moderately complex testing
FDA Level 3 Highly complex testing
Waived Level 1(FDA) simple labs cleared for home used by FDA (pregnancy test)
HIPPA is issued by US Department of Health and Human Service (HHS) 1996
Created by: kclaire03