Topic outline

  • Clinical Laboratory Improvement Amendments (CLIA)

    Clinical Laboratory Improvement Amendments (CLIA) from CMS.gov

    This site includes Interpretive Guidelines for Laboratories, How to apply for a CLIA certificate, Certificate of Waiver, CLIA Regulations and Federal Register Documents, etc.

    Consolidation of Personnel Policies for Individuals Directing or Performing Non-waived Tests under the Clinical Laboratory Improvement Amendments (CLIA) - Hospitals

    Presently CLIA-related personnel policies and procedures are dispersed throughout the regulations, State Operations Manual (SOM), Interpretive Guidelines, training presentations and in other less formal venues.  This memo attempts to consolidate and clarify them for the surveyor’s use and understanding.

    CLIA Program and Privacy Rule: Patients' Access to Test Reports

    Proficiency Test referral rules bring regulatory relief for labs

  • Centers for Medicare and Medicaid Services (CMS) - General Information page

    Centers for Medicare and Medicaid Services (CMS) - General Information page

  • Electronic Code of Federal Regulations

    The Electronic Code of Federal Regulations (e-CFR) is an electronic version of the Code of Federal Regulations (CFR).  The CFR is divided into “Titles”, with “Title 42  Public Health”, containing CMS regulations.  The Federal Register within the Government Printing Office publishes the CFR of an annual basis.  The e-CFR is updated on an ongoing basis.   The web address for the e-CFR is provided here.

  • This topic

    Emergency Medical Treatment & Labor Act (EMTALA)

    Per Centers for Medicare and Medicaid Services (CMS) - In 1986, Congress enacted the Emergency Medical Treatment & Labor Act (EMTALA) to ensure public access to emergency services regardless of ability to pay. Section 1867 of the Social Security Act imposes specific obligations on Medicare-participating hospitals that offer emergency services to provide a medical screening examination (MSE) when a request is made for examination or treatment for an emergency medical condition (EMC), including active labor, regardless of an individual's ability to pay. Hospitals are then required to provide stabilizing treatment for patients with EMCs. If a hospital is unable to stabilize a patient within its capability, or if the patient requests, an appropriate transfer should be implemented.

  • Health Information and the Law

    Look up federal and state law.

  • Health Information Portability and Accountability Act (HIPAA) - Office for Civil Rights - HHS

    Summary of the HIPAA Privacy Rule - Office for Civil Rights - HHS 25 page booklet

    Per Office for Civil Rights (OCR) - The Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) establishes, for the first time, a set of national standards for the protection of certain health information. The U.S. Department of Health and Human Services (“HHS”) issued the Privacy Rule to implement the requirement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The Privacy Rule standards address the use and disclosure of individuals’ health information—called
    “protected health information” by organizations subject to the Privacy Rule — called “covered entities,” as well as standards for individuals' privacy rights to understand and control how their health information is used.

    Understanding Health Information Privacy

    Per HHS.gov - The HIPAA Privacy Rule provides federal protections for individually identifiable health information held by covered entities and their business associates and gives patients an array of rights with respect to that information. At the same time, the Privacy Rule is balanced so that it permits the disclosure of health information needed for patient care and other important purposes.

  • Hospital-Acquired Conditions - CMS

    This site provides downloads and links pertaining to Hospital-Acquired Conditions.

  • Organ Procurement Organizations - US Code Title 42, Section 273

    Organ Procurement Organizations - US Code Title 42, Section 27. This contains laws in effect August 19, 2016

  • Occupational Safety & Health Administration - OSHA - Standard Interpretations - Bloodborne Pathogens

    Occupational Safety & Health Administration - OSHA - Standard Interpretations -

  • Social Security Act

    The laws that apply Medicare, Medicaid and other CMS programs are located in the Social Security Act (referred to as “The Act” or “SSA”).  The Act is divided up into “Titles”.  Medicare is Title XVIII and Medicare is Title XIX.  The web address to obtain the online SSA is provided here.

  • Various Acts

    American with Disabilities Act of 1990