1. Introduction to the Clinical Laboratory
Lesson 1-1
Introduction to the
Clinical Laboratory

2. Overview Laboratory regulation Types of clinical laboratories CLIA ‘88
Organization of hospital laboratory
Quality assessment
Privacy

3. 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

4. Types of Laboratories
See Table 1-1

5. Hospital Laboratories
Hospital organizational chart

6. Nonhospital Laboratories
Physician office laboratories (POLs)
Reference laboratories

7. Nonhospital Laboratories
Federal – CDC
States – Public health
Consultation
Reportable infectious diseases
Environmental tests

8. Centers for Disease Control and Prevention
Nation’s central public health laboratory
Standards and guidelines
Consultation
Education
Epidemiology
Laboratory Response Network

9. Classification of Tests
Waived
Moderate to high complexity
Provider performed microscopy procedures (PPMP)
Food and Drug Administration (FDA)
See Table 1-2

10. CLIA Certificate Categories
See Table 1-3
Certificate of
Waiver
Registration
Compliance
Accreditation
Provider performed microscopy procedures (PPMP)

11. Laboratory Organizational Chart

12. Personnel in the Hospital Laboratory
Laboratory director/pathologist
Technical supervisor/manager
General supervisor/department head
Testing personnel
See Table 1-4

13. Departments in the Laboratory
Hematology
Coagulation
Urinalysis
Clinical chemistry
Immunology
Blood bank

14. Departments in the Laboratory

15. Departments in the Laboratory
Microbiology
Support services
Laboratory information systems
Point-of-care testing (POCT)

16. Laboratory Request Form

17. Quality Assessment Continually evolving and expanding
Part of all laboratory activities
Proficiency testing
Accreditation
See Table 1-5

18. Privacy Issues

19. Privacy Issues HIPAA, 1996 Patient’s right to privacy Computers
Confidentiality
Electronic Health Records
Computers