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Tuesday, February 4, 2020 | History

4 edition of Code of Federal Regulations: Title 42, Public Health, Pt. 1-399 found in the catalog.

Code of Federal Regulations: Title 42, Public Health, Pt. 1-399

United States Government Printing Office

Code of Federal Regulations: Title 42, Public Health, Pt. 1-399

Revised as of October 1, 2002

by United States Government Printing Office

  • 114 Want to read
  • 18 Currently reading

Published by United States Government Printing Office .
Written in English

    Subjects:
  • General,
  • Political Science,
  • Politics/International Relations

  • The Physical Object
    FormatHardcover
    Number of Pages778
    ID Numbers
    Open LibraryOL10114475M
    ISBN 100160682673
    ISBN 109780160682674
    OCLC/WorldCa228090511

    The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias e. B Eligibility criteria for an alignment payment. Midlevel practitioner means a nurse midwife, nurse practitioner, or physician assistant, licensed by the State within which the individual practices, if such licensing is required in the State in which the laboratory is located. These data sets are of high value because the CFR contains all of the general and permanent regulations of the United States government, which affect nearly every aspect of life in the United States.

    A financial conflict of interest exists when the Institution, through its designated official sreasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to: i Public disclosure of financial conflicts of interest e. Validation review period means the one year time period during which CMS conducts validation inspections and evaluates the results of the most recent surveys performed by an accreditation organization or State laboratory program. Nonwaived test means any test system, assay, or examination that has not been found to meet the statutory criteria specified at section d 3 of the Public Health Service Act.

    Upper limits for drugs furnished as part of services. B Eligibility criteria for an alignment payment. Medical loss ratio MLR standards. FDA-cleared or approved test system means a test system cleared or approved by the FDA through the premarket notification k or premarket approval PMA process for in-vitro diagnostic use.


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Code of Federal Regulations: Title 42, Public Health, Pt. 1-399 book

The quality of care criteria must be established by the participant hospital and directly related to the CJR episode. These rules do not apply to components or functions of— 1 Any facility or component of a facility that only performs testing for forensic purposes; 2 Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients; or 3 Laboratories certified by the Substance Abuse and Mental Health Services Administration SAMHSAin which drug testing is performed which meets SAMHSA guidelines and regulations.

As used in this subpart: Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to an Institution. This search cannot be combined with any other search. State plan requirements, findings, and assurances. Calibration means a process of testing and adjusting an instrument or test system to establish a correlation between the measurement response and the concentration or amount of the substance that is being measured by the test procedure.

You may also obtain the entire text of the Part Number Pt. 1-399 book choosing the Part link at the top of your results page. Section a 16 of the Act authorizes the Secretary to prescribe State plan requirements for furnishing Medicaid to State residents who are absent from the State.

Upper limits for drugs furnished as part of services. Full credibility means a standard for which the experience of an MCO, PIHP, or PAHP is determined to be sufficient for the calculation of a MLR with a minimal chance that the difference between the actual and target medical loss ratio is not statistically significant.

The Web site shall note that the information provided is current as of the date listed and is subject to updates, on at least an annual basis and within 60 days of the Institution's identification of a new financial conflict of interest. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists.

II, Div. Substantial allegation of noncompliance means a complaint from any of a variety of sources including complaints submitted in person, by telephone, through written correspondence, or in newspaper or magazine articles that, if substantiated, would have an impact on the health and safety of the general public or of individuals served by a laboratory and raises doubts as to a laboratory's compliance with any condition level requirement.

Many volumes of the CFR are quite dynamic, changing substantially from year to year. Equivalency means that an accreditation organization's or a State laboratory program's requirements, taken as a whole, are equal to or more stringent than the CLIA requirements established by CMS, taken as whole.

If the Institution responds to written requests for the purposes of this subsection, the Institution will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the Institution's identification of a new financial conflict of interest, which should be requested subsequently by the requestor.

It is acceptable for an accreditation organization's or State laboratory program's requirements to be organized differently or otherwise vary from the CLIA requirements, as long as 1 all of the requirements taken as a whole would provide at least the same protection as the CLIA requirements taken as a whole; and 2 a finding of noncompliance with respect to CLIA requirements taken as a whole would be matched by a finding of noncompliance with the accreditation or State requirements taken as a whole.

Approved accreditation organization for laboratories means a private, nonprofit accreditation organization that has formally applied for and received CMS's approval based on the organization's compliance with this part. Non-claims costs means those expenses for administrative services that are not: Incurred claims as defined in paragraph e 2 of this section ; expenditures on activities that improve health care quality as defined in paragraph e 3 of this section ; or licensing and regulatory fees, or Federal and State taxes as defined in paragraph f 2 of this section.

Who do I contact if I have questions about this data? Several other regulations and policies apply to this subpart.

Web Automated Reference Material System

The term encompasses basic and applied research e. Target value for quantitative tests means either the mean of all participant responses after removal of outliers those responses greater than 3 standard deviations from the original mean or the mean established by definitive or reference methods acceptable for use in the National Reference System for the Clinical Laboratory NRSCL by the National Committee for the Clinical Laboratory Standards NCCLS.

These policies must contain criteria related to, and inclusive of, the quality of care delivered by the potential CJR collaborator. Test system means the instructions and all of the instrumentation, equipment, reagents, and supplies needed to perform an assay or examination and generate test results.

State includes, for purposes of this part, each of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands and a political subdivision of a State where the Public Health, acting pursuant to State law, has expressly delegated powers to the political subdivision sufficient to authorize the political subdivision to act for the State in enforcing requirements equal to or more stringent than CLIA requirements.

Each Institution shall: a Maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with this subpart, and make such policy available via a publicly accessible Web site. Institutional responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

This subpart promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service PHS grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.

State survey agency means the State health agency or other appropriate State or local agency that has an agreement under section of the Social Security Act and is used by CMS to perform surveys and inspections.

As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.CFR Title 42, Public Health; CFR Title 44, Emergency Management & Assistance; CFR Title 45, Public Welfare Code of Federal Regulations, Title 12, Banks and Banking, Pt.

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