Download presentation
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
Similar presentations
© 2025 SlidePlayer.com. Inc.
All rights reserved.