Introduction to the
Clinical Laboratory
Lesson 1-1
Overview
• Laboratory regulation
• Types of clinical laboratories
• CLIA ‘88
• Organization of hospital laboratory
• Quality assessment
• Privacy
Clinical Laboratory Regulation
• CLIA 1988– Specifies minimum standards
• Federal– Centers for Medicare and Medicaid Services
(CMS)
• States– Regulations must be as stringent as federal– Must not violate federal regulations
Types of Laboratories
• See Table 1-1
Hospital Laboratories
• Hospital organizational chart
Nonhospital Laboratories
• Physician office laboratories (POLs)
• Reference laboratories
Nonhospital Laboratories
• Federal – CDC
• States – Public health• Consultation• Reportable infectious diseases• Environmental tests
Centers for Disease Control and Prevention
• Nation’s central public health laboratory
• Standards and guidelines
• Consultation
• Education
• Epidemiology
• Laboratory Response Network
Classification of Tests
• Waived
• Moderate to high complexity
• Provider performed microscopy procedures (PPMP)
• Food and Drug Administration (FDA)
• See Table 1-2
CLIA Certificate Categories
• See Table 1-3
• Certificate of– Waiver– Registration– Compliance– Accreditation– Provider performed microscopy procedures
(PPMP)
LaboratoryOrganizational Chart
Personnel in the Hospital Laboratory
• Laboratory director/pathologist
• Technical supervisor/manager
• General supervisor/department head
• Testing personnel – See Table 1-4
Departments in the Laboratory
• Hematology– Coagulation– Urinalysis
• Clinical chemistry
• Immunology
• Blood bank
Departments in the Laboratory
• Microbiology
• Support services
• Laboratory information systems
• Point-of-care testing (POCT)
Departments in the Laboratory
Laboratory Request Form
Quality Assessment
• Continually evolving and expanding
• Part of all laboratory activities
• Proficiency testing
• Accreditation– See Table 1-5
Privacy Issues
Privacy Issues
• HIPAA, 1996
• Patient’s right to privacy– Confidentiality – Electronic Health Records
• Computers