1. Safety and Regulatory Guidelines In the Medical Laboratory
Chapter 38
Safety and Regulatory Guidelines In the Medical Laboratory

2. CLIA ‘88 Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88)
Federal regulations designed to set safety policies and procedures that protect patients
1967—misread Pap smears caused Congress to become more involved with regulating laboratories (CLIA ’88)

3. CLIA ‘88 Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88)
States can seek exemptions from CLIA standards and have state standards apply instead
Accrediting bodies granted “deemed status”

4. CLIA ’88 Overview
Is designed to protect public by regulating all laboratory tests performed on humans
Is based on complexity of tests performed
Affects all aspects of the laboratory

5. CLIA ’88 Overview
Specifies type of test performed, training and education of personnel involved in testing, and quality control

6. CLIA ’88 Testing Categories
Watch the video

7. CLIA ’88 Testing Categories
Waived tests
Simple, unvarying, and require minimum of judgment and interpretation
Moderate-complexity tests
Physician-performed microscopy procedures (PPMP) tests
High-complexity tests

8. CLIA ‘88 Consequences Contents of the law
List of analytes on the CLIA ’88 waived list
Types of CLIA certificates
Discuss the 17 components of CLIA described in this chapter
Review the text regarding CMS form 116

9. CLIA ‘88 Consequences
CLIA ’88 regulations for quality control in automated hematology
Required procedures
Calibration
Control samples
Proficiency testing
Check manufacturer’s recommendations for particular piece of equipment

10. CLIA ‘88 Consequences Aftermath of CLIA ’88
Has led to concerns about overload of paperwork it produces
Developments regarding postponements and funding problems
Recent findings of errors, gaps in quality in physician’s office laboratories (POLs)

11. CLIA ’88 and MAs
Covers all laboratories even if they perform a few basic tests
Documentation by medical assistants is important
Responsibility of medical assistants to teach and assist others who may not be trained

12. CLIA ’88 and MAs Where to find more information regarding CLIA ’88
Guidelines available from Federal Register and online

13. OSHA Regulations Occupational Safety and Health Administration (OSHA)
Intend for employees to have safe and healthful work environment
Present requirements employer must follow to ensure employee safety and health

14. OSHA Regulations Two standards comprise the regulations
The Bloodborne Pathogen Standard
Standards for Occupational Exposure to Hazardous Chemicals in the Laboratory
Purpose is to heighten employee awareness of risks linked with chemical dangers
Involves employee training and identification of hazardous chemicals

15. Chemical Hygiene Plan Core of the OSHA safety standard
Written plan specifies training and information requirements of standard
Describes requirements of standard

16. Chemical Hygiene Plan
Written CHP and program must be operational if chemicals are stored in facility and handled by employees
Describes three primary goals an employer must accomplish to be in compliance with OSHA standard for chemical exposure
Requirements of CHP

17. Chemical Hygiene Plan
Importance of chemical standards to medical assistants
All employees must comply or face penalties
All employees have right to know about hazards at work site and how to handle, store, and dispose of hazardous substances

18. OSHA Regulations and Students
Students do not fall under the OSHA guidelines but should take precautions