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

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)

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”

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

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

CLIA ’88 Testing Categories Watch the video

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

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

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

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)

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

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

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

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

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

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

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

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