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