[Federal Register: June 13, 1996 (Volume 61, Number 115)]
[Notices]
[Page 30072-30075]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn96-98]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[HSQ-231-N]
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory
Improvement Amendments of 1988 Exemption of Laboratories in the State
of Oregon
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice.
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SUMMARY: Section 353(p) of the Public Health Service Act provides for
the exemption of laboratories from the requirements of the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) when the State in
which they are located has requirements equal to or more stringent than
those of CLIA. This
[[Page 30073]]
notice grants exemption from CLIA requirements and is applicable only
to laboratories located within the State of Oregon that possess a valid
State license.
EFFECTIVE DATE: The provisions of this notice are effective on June 13,
1996, through December 31, 1999.
FOR FURTHER INFORMATION CALL: Val Coppola, (410) 786-3354.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
Section 353 of the Public Health Service Act, as amended by the
Clinical Laboratory Improvement Amendments of 1988 (CLIA), requires any
laboratory that performs tests on human specimens to meet the
requirements established by the Department of Health and Human
Services. Under the provisions of the sentence following section
1861(s)(14) and paragraph (s)(16) of the Social Security Act, any
laboratory that also requests to be paid for services furnished to
Medicare beneficiaries must meet the requirements of section 353 of the
Public Health Service Act. Subject to specified exceptions,
laboratories must have a current and valid CLIA certificate to test
human specimens to be eligible for payment from the Medicare or
Medicaid program. Regulations implementing section 353 of the Public
Health Service Act are contained in 42 CFR part 493, Laboratory
Requirements.
Section 353(p) of the Public Health Service Act provides for the
exemption of laboratories from CLIA requirements in a State that
applies requirements that are equal to or more stringent than those of
CLIA. The statute does not specifically require the promulgation of
criteria for the exemption of laboratories in a State. The decision to
grant CLIA exemption to laboratories within a State is at HCFA's
discretion, acting on behalf of the Secretary of Health and Human
Services.
Part 493, subpart E, Accreditation by a Private, Nonprofit
Accreditation Organization or Exemption Under an Approved State
Laboratory Program implements section 353(p) of the Public Health
Service Act. Section 493.513 provides that we may exempt from CLIA
requirements, for a period not to exceed 6 years, State licensed or
approved laboratories in a State if the State meets specified
conditions. Section 493.513(k) provides that we will publish a notice
in the Federal Register announcing the names and basis for exemption of
States whose laboratories are exempt from meeting the requirements of
part 493.
II. Notice of Approval of CLIA Exemption to Laboratories in the
State of Oregon
In this notice, we grant CLIA exemption for all specialties and
subspecialties to all laboratories located in the State of Oregon that
possess a valid license to perform laboratory testing effective June
13, 1996, through December 31, 1999.
III. Evaluation of The Oregon State Laboratory Program
The following describes the process we used to determine whether we
should grant exemption from CLIA requirements to licensed Oregon
laboratories.
A. Requirements for Granting CLIA Exemption
To determine whether we should grant a CLIA exemption to all
laboratories within the State of Oregon, we conducted a detailed and
indepth comparison of Oregon State's requirements for its laboratories
to those of CLIA and evaluated whether Oregon State's standards meet
the requirements at Sec. 493.513. In summary, we evaluated whether the
State of Oregon--
<bullet> Has laws in effect that provide for requirements that are
equal to or more stringent than CLIA requirements;
<bullet> Has an agency that licenses or approves laboratories
meeting State requirements that also meet or exceed CLIA requirements,
and would, therefore, meet the condition level requirements of the CLIA
regulations;
<bullet> Demonstrates that it has enforcement authority and
administrative structures and resources adequate to enforce its
laboratory requirements;
<bullet> Permits us or our agents to inspect laboratories within
the State;
<bullet> Requires laboratories within the State to submit to
inspections by us or our agents as a condition of licensure;
<bullet> Agrees to pay the cost of the validation program
administered by us and the cost of the State's pro rata share of the
general overhead to develop and implement CLIA as specified in
Secs. 493.645(a) Fee(s) applicable to accredited laboratories/approved
State licensure programs and 493.646(b) Payment of fees; and
<bullet> Takes appropriate enforcement action against laboratories
found by us or our agents not to be in compliance with requirements
comparable to condition level requirements.
We also evaluated whether the State of Oregon laboratory program
meets the requirements and licenses laboratories in accordance with
Sec. 493.515, Federal review of laboratory requirements of State
laboratory programs.
As specified in Sec. 493.515, our review of a State laboratory
program includes (but is not necessarily limited to) an evaluation of--
<bullet> Whether the State's requirements for laboratories are
equivalent to or more stringent than the CLIA condition level
requirements;
<bullet> The State's inspection process requirements to determine--
--The comparability of the full inspection and complaint inspection
procedures to our procedures;
--The State's enforcement procedures for laboratories found to be out
of compliance with its requirements; and
--The ability of the State to provide us with electronic data and
reports with the adverse or corrective actions resulting from
proficiency testing results that constitute unsuccessful participation
in HCFA-approved proficiency testing programs and with other data we
determine to be necessary for validation and assessment of the State's
inspection process requirements;
<bullet> The State's agreement to--
--Notify us within 30 days of the action taken against any CLIA-exempt
laboratory that has had its licensure or approval withdrawn or revoked
or been in any way sanctioned;
--Notify us within 10 days of any deficiency identified in a CLIA-
exempt laboratory in cases when the deficiency poses an immediate
jeopardy to the laboratory's patients or a hazard to the general
public;
--Notify each laboratory licensed by the State within 10 days of our
withdrawal of the exemption;
--Provide us with written notification of any changes in its licensure
(or approval) and inspection requirements;
--Disclose any laboratory's proficiency testing results in accordance
with the State's confidentiality requirements;
--Take the appropriate enforcement action against laboratories we find
not to be in compliance with requirements comparable to condition level
requirements and report these enforcement actions to us;
--Notify us of all newly licensed laboratories, including the
specialties and subspecialties for which any laboratory performs
testing, within 30 days; and
--Provide to us, as requested, inspection schedules for validation
purposes.
[[Page 30074]]
B. Evaluation of the Oregon State Request for CLIA Exemption
The State of Oregon has formally applied to us for an exemption
from the CLIA requirements for laboratories located within the State
that possess a valid State license.
We have evaluated the Oregon State's CLIA exemption application and
all subsequent submissions for equivalency against the three major
categories of CLIA rules: The implementing regulations, the enforcement
regulations, and the deeming/exemption requirements. The statutory
requirements pertaining to laboratories in Oregon are found at Chapter
438, Clinical Laboratories, in the Oregon Revised Statutes. We found
the Laboratory Licensing Section of the Center for Public Health
Laboratories, which issues, implements, and enforces regulations
specified in the Oregon Administrative Rule, Division 24, Chapter 333,
to administer a program that is equal to the CLIA program, taken as a
whole. We performed an indepth evaluation of the Oregon application to
verify the State's assurance of compliance with the following subparts
of part 493.
Subpart E, Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory
Program
HCFA and the Centers for Disease Control and Prevention staff
reviewers have examined the Oregon State application and all subsequent
submissions against the exemption requirements that a State must meet
in order to be granted CLIA-exempt status (Sec. 493.513 and the
applicable parts of Secs. 493.515, 493.517, 493.519, and 493.521, which
concern General requirements for CLIA-exempt laboratories; Federal
review of laboratory requirements of State laboratory programs;
Validation inspections of CLIA-exempt laboratories; Continuing Federal
oversight of an approved State laboratory program; and Removal of CLIA
exemption and final determinations review). The State has complied with
the applicable CLIA requirements for exemption under this subpart.
Subpart H, Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate Complexity (Including the
Subcategory), High Complexity, or Any Combination of These Tests
The Oregon Administrative Rule requires licensed laboratories
within Oregon to enroll and participate in a HCFA-approved proficiency
testing program for all tests listed in Subpart I of the CLIA
regulations. Oregon has adopted the requirements of Subpart H,
Participation in proficiency testing for laboratories performing tests
of moderate complexity (including the subcategory), high complexity, or
any combination of these tests.
Therefore, the proficiency testing requirements of Oregon are
equivalent to those of CLIA.
Subpart J, Patient Test Management for Moderate Complexity
(Including the Subcategory), High Complexity, or Any Combination of
These Tests
Oregon has modified its requirements for patient test management to
be equal to those of the CLIA regulations.
Subpart K, Quality Control for Tests of Moderate Complexity
(Including the Subcategory), High Complexity, or Any Combination of
These Tests
The Oregon Administrative Rule recognizes the CLIA categorization
of tests and stipulates quality control requirements for moderate
complexity (including the subcategory of provider performed
microscopy), and high complexity tests that are equivalent to the
respective CLIA requirements, taken as a whole.
Subpart M, Personnel for Moderate Complexity (Including the
Subcategory) and High Complexity Testing
The personnel requirements of the Oregon Administrative Rule are
equivalent to those of CLIA for all levels of testing complexity.
Subpart P, Quality Assurance for Moderate Complexity (Including the
Subcategory) or High Complexity Testing, or Any Combination of
These Tests
The applicable standards of the Oregon Administrative Rule are
equal to the CLIA requirements at Secs. 493.1701 through 493.1721,
which address quality assurance.
Subpart Q, Inspection
Oregon laboratories that possess a license for moderate or high
complexity testing are routinely inspected on-site, biennially. Routine
inspections are usually announced. All complaint inspections are
unannounced. The Oregon State Laboratory Licensing Section implements
inspection requirements and policies that are equal to those of CLIA.
Subpart R, Enforcement Procedures
We have reviewed documentation of Oregon State's enforcement
authority, its administrative structure and the resources used to
enforce its standards. The State appropriately applies limitations and
revocations of its licenses for laboratories as well as other
categories of penalties. Dependent upon probable circumstances, Oregon
may impose a directed plan of correction, it may refuse to issue a
license or permit, or, if necessary, it could initiate criminal
penalties.
The State of Oregon has provided us with the mechanism it currently
uses to monitor the proficiency testing performance of its
laboratories. The initial action taken by Oregon State for unsuccessful
proficiency testing performance requires the laboratory to determine
the cause of the failure, document corrective actions and provide an
assurance that patient testing is correctly performed. If no response
or an inadequate response is received, procedures to remove the
analyte, subspecialty, or specialty from the laboratory's license will
be initiated. The State may perform an on-site inspection due to
unsuccessful proficiency testing performance.
The State of Oregon has provided appropriate documentation
demonstrating that its enforcement policies and procedures are
equivalent to those of CLIA.
IV. Federal Validation Inspections and Continuing Oversight
The Federal validation inspections of CLIA-exempt laboratories, as
specified in Sec. 493.517, will be conducted on a representative sample
basis as well as in response to substantial allegations of
noncompliance (complaint inspections). The outcome of those validation
inspections will be our principal means for verifying the
appropriateness of the exemption given to laboratories in Oregon. This
Federal monitoring is an on-going process. The State of Oregon will
provide us with survey findings for each laboratory selected for
validation.
[[Page 30075]]
V. Removal of Approval of Oregon State Exemption
We will remove the CLIA exemption of laboratories located in the
State of Oregon that possess a valid license if we determine the
outcome and comparability review of validation inspections are not
acceptable as described under Sec. 493.521 or if the State fails to pay
the required fee as stated under Sec. 493.645(a).
VI. Laboratory Data
In accordance with Sec. 493.513(d)(2)(iii), Oregon State will
provide us with changes to a laboratory's specialties or subspecialties
based on the State's survey and with changes in a laboratory's
licensure status.
VII. Required Administrative Actions
CLIA is a user-fee funded program. The registration fee paid by the
laboratories is used to cover the cost of the development and
administration of the program. However, when a State's application for
exemption is approved, we may not charge a fee to laboratories in the
State that are covered by the exemption. The State's share of the costs
associated with CLIA must be collected from the State. Section 493.645
specifies that Health and Human Services assesses fees that a State
must pay for the following:
<bullet> Costs of Federal inspection of laboratories in the State
to verify that standards are enforced in an appropriate manner. The
average cost per validation survey nationally is multiplied by the
number of surveys that will be conducted.
<bullet> Costs incurred for Federal investigations and surveys
triggered by complaints that are substantiated. We bill the State for
these costs. We anticipate that most of these surveys will be referred
to the State and that there will be little Federal activity in this
area.
<bullet> The State's proportionate share of general overhead costs
for the items and services it benefits from and only for those paid for
out of registration or certificate fees we collected.
In order to estimate Oregon State's proportionate share of the
general overhead costs, we determined the ratio of laboratories in
Oregon State to the total number of laboratories nationally. In that
the general overhead costs apply equally to all laboratories, we
determined the cumulative overhead costs that should be assumed by the
State of Oregon.
The State of Oregon has agreed to pay us its pro rata share of the
overhead costs and anticipated costs of actual validation and complaint
investigation surveys. A final reconciliation for all laboratories and
all expenses will be made. We will reimburse the State for any
overpayment or bill it for any balance.
In accordance with the provisions of Executive Order 12866, this
notice was not reviewed by the Office of Management and Budget.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
Dated: May 13, 1996.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 96-14969 Filed 6-12-96; 8:45 am]
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