Regulation, Accreditation, and Legislation Flashcards
concerns from the Centers for Medicare and Medicaid Services (CMS) about fraud and abuse of payments.
The Laboratory Compliance Program
was enacted in 1996, providing standards that protect the confidentiality of health information while allowing interchange of information in appropriate circumstance
Health Insurance Portability and Accountability Act (HIPAA)
established payment based on diagnosis-related group
prospective payment system
Established outpatient laboratory fee schedule to control costs
deficit reduction act
Established that all laboratories must be certified by the federal government with mandated quality assurance, personnel, and proficiency testing standards based on test complexity.
Clinical Laboratory Improvement Act of 1988 (CLIA ‘88)
Prevents physicians from referring Medicare patients to self-owned laboratories
Physician Self-referral Ban
Establish OSHA guidelines for employee safety.
Ergonomic Safety and Health Program Management Guidelines
Payment for any laboratory testing done 3 calendar days before admission as an inpatient is not reimbursed because testing is considered to be part of the hospital stay
Three-day rule
limit unnecessary exposure to hazardous chemicals
Occupational Exposure to Hazardous Chemicals in Laboratories
limit unnecessary exposure to biological hazards.
Occupational Exposure to Blood-Borne Pathogens
Directs how health care information is managed
Health Insurance Portability and Accountability Act
programs that promote high ethical and lawful conduct, especially regarding billing practices and fraud and abuse.
OIG Compliance Guidelines
used to determine whether certain laboratory tests are medically necessary and therefore reimbursable
CMS National Coverage Determinations
Deal with shipment of blood and other potentially biohazardous products (DOT)
Hazardous Material Regulation
provides oversight of public health and safety, including the laboratory
Center for Disease Control and Prevention
largest health care program in the United States, processing more than 1 billion claims per year
Centers for Medicare and Medicaid Services
regulating biohazardous materials that include blood and other human products
U.S. Department of Transportation
sets and enforces standards for disposal of hazardous laboratory materials, such as formalin, xylene, and other potential carcinogens
Environmental Protection Agency
regulates the manufacture of biologics
U.S. Food and Drug Administration
provides a number of databases, including access to the Federal Register, where laboratory and other regulations are published
National Archives and Records Administration
enforces federal guidelines that ensure the proper use and operation of nonmilitary nuclear facilities
Nuclear Regulatory Commission
regulates standards for performing and maintaining appropriate quality control for drugs of abuse testing
National Institute on Drug Abuse
an agency of HHS and is a world leader in medical research.
National Institutes of Health
a peer professional group that offers a blood bank accreditation program that can substitute for (but
coordinate with) a CAP inspection.
American Association of Blood Bank
the largest organization for laboratory professionals and offers certification for various specialties
American Society for Clinical Pathology
the largest proficiency survey program in the United States and has a peer surveyed laboratory accreditation program that has CLIA deemed status.
College of American Pathologists
