[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR488.1]

[Page 638-639]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                 HEALTH AND HUMAN SERVICES--(Continued)
 
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 488.1  Definitions.


    As used in this part--

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    Accredited provider or supplier means a provider or supplier that 
has voluntarily applied for and has been accredited by a national 
accreditation program meeting the requirements of and approved by CMS in 
accordance with Sec. 488.5 or Sec. 488.6.
    Act means the Social Security Act.
    AOA stands for the American Osteopathic Association.
    Certification is a recommendation made by the State survey agency on 
the compliance of providers and suppliers with the conditions of 
participation, requirements (for SNFs and NFs), and conditions of 
coverage.
    Conditions for coverage means the requirements suppliers must meet 
to participate in the Medicare program.
    Conditions of participation means the requirements providers other 
than skilled nursing facilities must meet to participate in the Medicare 
program and includes conditions of certification for rural health 
clinics.
    Full review means a survey of a hospital for compliance with all 
conditions of participation for hospitals.
    JCAHO stands for the Joint Commission on Accreditation of Healthcare 
Organizations.
    Medicare condition means any condition of participation or for 
coverage, including any long term care requirements.
    Provider of services or provider means a hospital, critical access 
hospital, skilled nursing facility, nursing facility, home health 
agency, hospice, comprehensive outpatient rehabilitation facility, or 
provider of outpatient physical therapy or speech pathology services.
    Rate of disparity means the percentage of all sample validation 
surveys for which a State survey agency finds noncompliance with one or 
more Medicare conditions and no comparable condition level deficiency 
was cited by the accreditation organization, where it is reasonable to 
conclude that the deficiencies were present at the time of the 
accreditation organization's most recent surveys of providers or 
suppliers of the same type.
    Example: Assume that during a validation review period State survey 
agencies perform validation surveys at 200 facilities of the same type 
(for example, ambulatory surgical centers, home health agencies) 
accredited by the same accreditation organization. The State survey 
agencies find 60 of the facilities out of compliance with one or more 
Medicare conditions, and it is reasonable to conclude that these 
deficiencies were present at the time of the most recent survey by an 
accreditation organization. The accreditation organization, however, has 
found deficiencies comparable to the condition level deficiencies at 
only 22 of the 60 facilities. These validation results would yield ((60-
22)/200) a rate of disparity of 19 percent.
    Reasonable assurance means that an accreditation organization has 
demonstrated to CMS's satisfaction that its requirements, taken as a 
whole, are at least as stringent as those established by CMS, taken as a 
whole.
    State includes the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, Guam, and American Samoa.
    State survey agency means the State health agency or other 
appropriate State or local agency used by HFCA to perform survey and 
review functions for Medicare.
    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 affect the health and safety of 
patients and raises doubts as to a provider's or supplier's 
noncompliance with any Medicare condition.
    Supplier means any of the following: Independent laboratory; 
portable X-ray services physical therapist in independent practice; ESRD 
facility; rural health clinic; Federally qualified health center; or 
chiropractor.
    Validation review period means the one year period during which CMS 
conducts a review of the validation surveys and evaluates the results of 
the most recent surveys performed by the accreditation organization.

[53 FR 22859, June 17, 1988, as amended at 54 FR 5373, Feb. 2, 1989; 56 
FR 48879, Sept. 26, 1991; 57 FR 24982, June 12, 1992; 58 FR 30676, May 
26, 1993; 58 FR 61838, Nov. 23, 1993; 62 FR 46037, Aug. 29, 1997]

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