5: REGULATION, ACCREDITATION, AND LEGISLATION Flashcards
- for medicare patients who establish payment based on diagnosis related groups (DRG)
o patient classification scheme - hospitals are paid affects amount per DRG
1983: PROSPECTIVE PAYMENT SYSTEM
- establish out-patient laboratory fee to schedule control cost.
1984: DEFICIT REDUCTION ACT “DEFRA”
- all laboratories must be certified by the federal government with mandated quality assurance, personnel, and proficiency testing standards.
1988: CLINICAL LABORATORY IMPROVEMENT ACT (CLIA) OF 1988
- prevents the physician from referring medicare patients to self-owned lab
1989: PHYSICIAN SELF REFERRAL BAN
- payment for any lab testing done within three calendar days before admission as in-patient will not be reimbursed
1990: THREE-DAY RULE
- establishes OSHA guidelines to limit unnecessary exposure to biological hazards
1992: EXPOSURE TO BLOODBORNE PATHOGEN
- establishes OSHA guidelines to limit unnecessary exposure to hazardous chemicals
OCCUPATIONAL EXPOSURE TO HAZARDOUS CHEMICALS
- this law protects patient from inappropriate dispersion of personal info
- access to Protected Health Info (PHI)
1996: HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY (HIPAA)
- help the laboratories to develop programs that promote high ethical and lawful conduct
1997: OIG COMPLIANCE GUIDELINES
- physicians must know how to select the most appropriate test needed and should avoid the “shotgun” approach to test ordering practices
AUGUST 24, 1998
- replace most local medical review policies which are used to determine whether laboratory tests are medically necessary and reimbursable.
2001: CMS NATIONAL COVERAGE DETERMINATIONS
- deals with shipment of blood and other potentially biohazardous products.
2003: HAZARDOUS MATERIAL REGULATIONS
- contains incentives related to adoption of healthcare information technology and electronic health record.
- provide patient the access to their PHI of which the access provided within 30 days of the request.
2007: HI-TECH ACT (EHR)
- Under the US Department of health and human services
- HHS (Human Health Services) – Comparable to DOH
- For public health safety.
Centers for Disease Control and Prevention (CDC)
- Largest Healthcare medical programs in the US
o Medicare
o Medic Aid
Low – income individuals
Centers for Medicare and Medicaid Services (CMS)
- Enforces standards for disposal of hazardous lab materials
- Hazardous Lab Materials
o Formalin
o Xylene
o Potential Carcinogens
Environmental Protection Agency (EPA)
- Dealing with fair employment practices.
Equal Employment Opportunity Commission (EEOC)
- Part of HHS
- Regulate and Manufactures of biologics ad medical devices and test kits.
Food and Drug Administration (FDA)
- Oversees CMS, OIG, and FDA
Department of Human Health and Services (HHS)
- Provides databases and access to the federal register.
o Lab and regulations are published.
National Archives and Records Administration (NARA)
- Enforces federal guidelines for the proper use of non-military nuclear facilities.
Nuclear Regulatory Commission (NRC)
- Performing and maintaining quality control for drug abuse testing.
National Institute on Drug Abuse (NIDA)
- Part of HHS
- Provides research, information, and training in the field of occupational safety and health
- Recommendations regarding health hazards
- No authorities with enforcing.
National Institute for Occupational Safety and Health (NIOSH)
- World Leader in Medical Research.
National Institute of Health (NIH)
- Commerce Department
- Contributed to the development of many healthcare products.
National Institute of Standards and Technology (NIST)
- Part of HHS
- Responsible for auditing, inspecting, and identifying fraud and abuse in CMS programs.
Office of Inspector General (OIG)
- Department of Labor
- Develops and enforces workplace standards to protect employees’ safety and health.
Occupational Safety and Health Administration (OSHA)
- Identifies, regulates, and may inspect high-risk chemical facilities and radiation sources that may be risks for terrorism.
Department of Homeland Security (DHS)
- A pear professional group that offers a blood bank accreditation.
American Association of Blood Banks (AABB)
- The largest organization for laboratory professionals and offers certification for various specialties.
American Society for Clinical Pathology (ASCP)
- Offers the largest proficiency program in the US.
College of American Pathologists (CAP)
- Develops standardized criteria regarding laboratory practices.
Clinical and Laboratory Standards Institute (CLSI)
- A nonprofit organization that provide assistance to physician office laboratories.
Commission on Office Laboratory Accreditation (COLA)
- A nonprofit organization that accredits nearly 17,000 health care organization and program-based quality standards.
The Joint Commission (TJC)
- A laboratory in a government hospital that had been designated by the DOH to provide special functions and services for specific diseases.
o Confirmatory
o Training
o Research
o EQAS – External Quality Assurance and Services
o Validate test kits & Reagents (RGTS)
NATIONAL REFERENCE LABORATORIES
- Clinical Chemistry
Lung Center of the Philippines (LCP)
- Hematology
- Immunohematology
- Immunopathology
- Anatomical Pathology
National Kidney Transplant Institute (NKTI)
- Drug Testing
- Water Microbiology
East Avenue Medical Center (EAMC)
- SACCL – STS/AIDS Central Cooperative Laboratory.
- Serology
San Lazaro Hospital (SLH)
- Microbiology - Bacteria
- Parasitology - Parasite
- Mycology - Fungi
- Virology – Virus
Research Institute for Tropical Medicine (RITM)
PROSPECTIVE PAYMENT SYSTEM
1983
DEFICIT REDUCTION ACT “DEFRA”
1984
CLINICAL LABORATORY IMPROVEMENT ACT (CLIA)
1988
PHYSICIAN SELF REFERRAL BAN
1989
THREE-DAY RULE
1990
EXPOSURE TO BLOODBORNE PATHOGEN
1992
- establishes OSHA guidelines to limit unnecessary exposure to hazardous chemicals
OCCUPATIONAL EXPOSURE TO HAZARDOUS CHEMICALS
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY (HIPAA)
1996
OFFICE OF INSPECTOR GENERAL (OIG) COMPLIANCE GUIDELINES
1997
CMS NATIONAL COVERAGE DETERMINATIONS
2001
HAZARDOUS MATERIAL REGULATIONS
2003
HI-TECH ACT
2007
