Approved for use
through 10/99 under the condition that the next submission for OMB
clearance includes the underlying CLIA and OPO state
surveyor/regional office guidance.
Inventory as of this Action
Requested
Previously Approved
11/30/1999
11/30/1999
11/30/1998
60,000
0
98,400
120,000
0
196,800
0
0
0
This paperwork package provides
information regarding the form used by the Medicare, Medicaid, and
the Clinical Laboratory Improvement Amendments (CLIA) programs to
document a health care facility's compliance or noncompliance
(deficiencies) with regard to the Medicare/Medicaid Conditions of
Participation and Coverage, the requirements for participation for
Skilled Nursing Facilities and Nursing Facilities, and for
certification under CLIA. This form becomes the evidentiary basis
for HCFA certification decisions (including termination or denial
of participation) and the form of public assistance.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Statement of Deficiencies and Plan of Correction -- 42 CFR 488.18, 488.26, and 488.28