[Federal Register Volume 60, Number 166 (Monday, August 28, 1995)]
[Notices]
[Pages 44503-44507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21264]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HSQ-230-N]
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory
Improvement Amendments of 1988 Exemption of Permit-Holding Laboratories
in the State of New York
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 notice grants exemption from CLIA requirements
applicable only to laboratories located within the State of New York,
including New York City, that possess a valid permit, as mandated under
Part 58, and Article Five of Title V of the Public Health Law of the
State of New York. This title is applicable to all laboratories except
those operated by an individual, licensed physician, osteopath,
dentist, podiatrist, or a physician's group practice which performs
laboratory tests personally or through his or her employees, solely as
an adjunct to the treatment of his or her own patients.
EFFECTIVE DATE: The provisions of this notice are effective on August
28, 1995 to June 30, 2001.
FOR FURTHER INFORMATION CALL: Val Coppola, (410) 786-3406.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
Section 353 of the Public Health Service Act (PHS Act), as amended
by the Clinical Laboratory Improvement Amendments of 1988 (CLIA),
requires any laboratory that performs tests on human specimens to meet
requirements established by the Department of Health and Human Services
(HHS). Under the provisions of the sentence following section
1861(s)(14) and paragraph (s)(16) of the Social Security Act, any
laboratory that also wants to be paid for services furnished to
Medicare beneficiaries must meet the requirements of section 353 of the
PHS Act. Subject to specified exceptions, laboratories must have a
current and valid CLIA certificate to test human specimens and to be
eligible for payment from the Medicare or Medicaid program. Regulations
implementing
[[Page 44504]]
section 353 of the PHS Act are contained in 42 CFR part 493.
Section 353(p) of the PHS 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 our discretion,
acting on behalf of the Secretary of HHS.
Part 493, subpart E, implements section 353(p) of the PHS 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 of States whose laboratories are exempt from
meeting the requirements of part 493.
II. Notice of Approval of CLIA Exemption to New York State
Laboratories
In this notice, we grant CLIA exemption for all specialties and
subspecialties to all laboratories located in the State of New York,
including New York City, that possess a valid permit to perform
laboratory testing effective August 28, 1995 to June 30, 2001.
III. Evaluation of New York State (NYS) Laboratories
The following describes the process we used to determine whether we
should grant exemption from CLIA requirements to permit-holding NYS
laboratories.
A. Requirements for Granting CLIA Exemption
To determine whether we should grant a CLIA exemption to all
laboratories within the State of New York, we conducted a detailed and
in-depth comparison of NYS' requirements for its laboratories to those
of CLIA and evaluated whether NYS' standards meet the requirements at
Sec. 493.513. In summary, we evaluated whether NYS--
Has laws in effect that provide for requirements that are
equal to, or more stringent than, CLIA requirements;
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;
Demonstrates that it has enforcement authority and
administrative structures and resources adequate to enforce its
laboratory requirements;
Permits us or our agents to inspect laboratories within
the State;
Requires laboratories within the State to submit to
inspections by us or our agents as a condition of licensure;
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(b) and 493.646; and
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 NYS laboratories meet the requirements
and are approved 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--
Whether the State's requirements for laboratories are
equivalent to, or more stringent than, the condition level
requirements;
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 (PT) results that constitute unsuccessful
participation in HCFA-approved PT programs and with other data we
determine to be necessary for validation and assessment of the State's
inspection process requirements;
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 PT results in accordance with a 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.
B. Evaluation of the New York State Request for CLIA Exemption
The State of New York has formally applied to us for an exemption
from the CLIA requirements for the permit-holding laboratories located
within the State, including those in New York City. This exemption does
not apply to laboratories outside of the State of New York that possess
a NYS permit to perform laboratory testing on specimens from NYS
residents. In addition, this exemption does not apply to laboratories
operated by an individual, licensed physician, osteopath, dentist,
podiatrist, or a physician's group practice which performs laboratory
tests personally or through his or her employees, solely as an adjunct
to the treatment of his or her own patients.
We have evaluated the NYS 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. We found the NYS
Clinical Laboratory Evaluation Program, which issues, implements, and
enforces regulations specified in Part 58 and Article Five of Title V
of the Public Health Law of the State of New York, to administer a
program that is more stringent than the CLIA program, taken as a whole.
Rather than enumerating every more stringent item of the NYS
requirements, we have included in this notice the more significant and
exemplary areas of stringency. We performed an indepth evaluation of
the NYS application to verify the State's assurance of compliance with
the following subparts of part 493.
Our evaluation identified more stringent areas of the NYS
requirements that apply to the laboratory as a whole. Rather than
include them in the appropriate subparts multiple times, we list them
here:
[[Page 44505]]
NYS has extensive requirements involving laboratory
safety. They include detailed standards for biosafety, chemical safety,
radiological safety and regulated medical waste.
NYS permit holding laboratories that use a laboratory
information system (LIS) for any aspect of specimen testing, reporting,
and/or record keeping must adhere to all applicable provisions of part
58 and including, but not limited to, the following:
--Test results are reported, archived, and maintained in an accurate
and reliable manner.
--Performance and documentation of system maintenance required by the
LIS manufacturer, or established and validated by the laboratory.
--All devices are maintained to ensure accurate, clear, and
interference-free report transmissions.
--New or revised software and/or hardware is validated prior to use.
--Written back-up procedures are available for test reporting and
retrieval when the LIS is out of service.
--The LIS is capable of generating an exact duplicate of a final test
report and any preliminary report.
--LIS data and programs are protected from unauthorized use.
NYS regulations provide requirements for forensic testing
to include PT when applicable.
NYS regulations list requirements covering paternity
testing as well as workplace drug testing.
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 (CDC) staff
reviewers have examined the NYS application and all subsequent
submissions against the exemption requirements 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). 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 statute and implementing regulations of NYS for PT are more
stringent than those of CLIA. Permit-holding laboratories are required
by NYS statute to participate in the NYS PT program for all testing
performed, provided it is offered by the program. Laboratories must
enroll and participate in PT for all testing regardless of the CLIA
categorization of waived, moderate, or high complexity. The PT testing
available through the NYS PT program is much more extensive than the
list of tests included in the CLIA regulations. The NYS program offers
many more analytes, as well as additional specialties and
subspecialties beyond those in the CLIA requirements.
The NYS PT program, which we have approved under CLIA, meets the
requirements of subpart I, Proficiency Testing Programs for Tests of
Moderate or High Complexity or Both, and in some areas, exceeds the
CLIA PT program requirements. The passing scores are higher than those
of CLIA for human immunodeficiency virus testing and for antibody
detection and antibody identification. Because the PT program is a part
of the CLIA exemption application, the State may include PT
requirements that are equal to or more stringent than those of CLIA.
PT performance is closely monitored by the NYS Clinical Laboratory
Evaluation Program. If a laboratory fails a particular PT event, the
laboratory is notified in writing. If a laboratory fails two
consecutive or two of three PT events (unsuccessful performance), the
laboratory must stop testing for the unsuccessful category and/or
analyte.
Laboratories that wish to add a category or a test to a permit must
successfully complete two consecutive PT testing events prior to the
initiation of patient testing. New laboratories must also participate
successfully in two events before testing patient specimens. The CLIA
regulations do not contain such requirements.
Subpart J, Patient Test Management for Moderate Complexity (Including
the Subcategory), High Complexity, or Any Combination of These Tests
The NYS requirements for patient test management are more stringent
than those of CLIA. Areas of stringency that exceed CLIA requirements
are:
Oral test requests are followed by a written request
within 48 hours. If not received in this timeframe, the requestor is
notified and the written authorization received within 30 days.
Retention records for test requests, accession records and
laboratory reports is 7 years; however, pathology reports must be
retained for 20 years, and cytogenetics and genetic testing reports
must be held for 25 years.
State permit-holding laboratories may only refer specimens
for testing to other laboratories that hold applicable State permits.
A specimen received by a laboratory must not be tested or
results reported if--
--It is unsatisfactory or inappropriate for the test requested;
--It has been collected, labeled, preserved, stored, transported or
otherwise handled in a manner that caused it to become unsatisfactory
or unreliable as a test specimen;
--It is labile and the time lapse between collection and receipt is
such that it may no longer be reliable;
--The date and hour of collection, when required by the method or
procedure, are not furnished; and
--The test is investigational and the laboratory does not have
authorization from both the ordering individual and the patient
indicating their awareness of the test limitations and investigational
nature before the test is performed;
Specific confidentiality protocols are required that must
include--
--A definition of confidential information and prohibition of
unauthorized access;
--The responsibilities of the director/assistant director to determine
appropriate release and access to information;
--The responsibilities of employees;
--The contents of required in-service training programs;
--A mechanism for documenting attendance and attestation statements
from each employee who is authorized to access confidential
information; and
--The consequences of violation of confidentiality requirements which
may include criminal prosecution.
Laboratories must not report the results of a test on a
specimen unless the test request information listed in the regulations
has been obtained; and
Specific requirements are listed for patient service
centers (specimen collection).
Subpart K, Quality Control for Tests of Moderate Complexity (Including
the Subcategory), High Complexity, or Any Combination of These Tests
The NYS requirements on quality control (QC) are more stringent
than CLIA requirements as all testing including waived tests under CLIA
must meet all QC requirements for high complexity testing. NYS has
never allowed a phase-in for any of its QC requirements.
NYS permitted laboratories must perform method validation before a
test procedure is placed into routine use and
[[Page 44506]]
maintain documentation of the validations of all procedures while they
are in use. The linear reportable range must be established or verified
for all applicable procedures. Three levels of controls must be
employed for quantitative chemistry testing if calibration is not
performed or validated within a run of more than 24 hours. Trilevel
controls are required for quantitative immunology testing. HIV testing
must be a repeatable positive and a confirmatory test performed by an
appropriately permitted NYS laboratory before reporting a positive
result.
The items listed above are more stringent requirements and
exemplify the QC contents of the NYS program which, taken as a whole,
are more stringent than the QC requirements of CLIA.
Subpart M, Personnel for Moderate Complexity (Including the
Subcategory) and High Complexity Testing
The personnel requirements of NYS are more stringent than those of
CLIA, taken as a whole. CLIA allows lesser qualified individuals to
direct a laboratory performing moderate complexity tests, compared to
the qualification requirements for individuals directing a laboratory
in which high complexity testing is performed. CLIA has no requirements
for an individual or laboratory engaged in waived test performance. NYS
treats all testing in a manner similar to CLIA's high complexity tests.
Therefore, NYS does not allow a laboratory to be directed by
individuals possessing appropriate qualifications for CLIA's moderate
test performance, nor does it allow a laboratory to be directed by
individuals possessing the qualifications for waived test performance.
Individuals who wish to direct a permit holding laboratory must
obtain a Certificate of Qualification through the Clinical Laboratory
Evaluation Program. They must formally apply and submit documentation
of professional and academic expertise in all the specialties and
subspecialties for which the laboratory conducts testing and holds a
NYS permit. The documentation is evaluated and approved by the Clinical
Laboratory Evaluation Program professional staff, in accordance with
the NYS Public Health law and regulations.
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 NYS regulations have been revised
and are equivalent to the CLIA requirements at Secs. 493.1701 through
493.1721 concerning quality assurance. NYS does, however, require
laboratories to evaluate and define the relationship between the same
test by different methods or different instrument three times per year.
CLIA requires this evaluation twice a year.
Subpart Q, Inspection
The NYS permit-holding laboratories are routinely inspected on-site
biennially. Routine inspections and complaint inspections are performed
on an unannounced basis. Inspection for a laboratory first entering the
program is scheduled after the facility has notified the Clinical
Laboratory Evaluation Program that it is prepared to begin patient
testing. A new laboratory will not receive a NYS permit until an on-
site inspection is performed and all identified deficiencies have been
corrected. This requirement and the use of unannounced compliance
inspections are more stringent than those of CLIA. We conduct
compliance inspections to monitor the correction of deficiencies and
ensure that laboratories continue to meet State standards.
NYS also uses a protocol similar to that of HCFA for complaint
investigations involving laboratories performing cytopathology. This
inspection focuses on all cytology requirements and, if indicated,
retrospective rescreens of previously read cytology cases are
performed.
Subpart R, Enforcement Procedures
We have reviewed documentation of the State's enforcement
authority, its administrative structure and the resources used to
enforce its standards for completeness. The State appropriately applies
limitations and revocations of its permits for laboratories as well as
intermediate sanctions such as on-site monitoring of laboratories and
imposition of civil money penalties.
The State has provided us with the mechanism it currently uses to
monitor the PT performance of its laboratories. The action NYS takes
for unsuccessful PT participation is more stringent than those of
CLIA's enforcement policy. A permitted laboratory must suspend testing
for the unsuccessful analyte or category until it successfully
remediates the problem area. The State has provided appropriate
documentation demonstrating that its enforcement policies and
procedures are equivalent to those of CLIA.
IV. Federal Validation Inspections and Continuing Oversight
We will conduct the Federal validation inspections of CLIA-exempt
laboratories, as specified in Sec. 493.517, 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 NYS. This
Federal monitoring is an on-going process. The State of New York will
provide us with survey findings for each laboratory selected for
validation.
V. Removal of Approval of New York State Exemption
We will remove the CLIA exemption of laboratories located in NYS
that possess a valid permit 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 every 2 years as required under Sec. 493.646.
VI. Laboratory Data
In accordance with Sec. 493.513(d)(2)(iii), NYS 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 permit status.
VII. Required Administrative Actions
CLIA is intended to be generally a user-fee funded program. The
registration fee paid by the laboratories is intended 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. We will
collect the State's share of the costs associated with CLIA from the
State. Section 493.645 specifies that HHS will assess fees that a State
must pay for the following:
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.
Costs incurred for Federal investigations and surveys
triggered by complaints that are substantiated. We
[[Page 44507]]
will bill the State on an semi-annual basis. We anticipate that most of
these surveys will be referred to the State and that there will be
little Federal activity in this area.
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 the State's proportionate share of the general
overhead costs, we determined the ratio of laboratories in the 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 borne by the State of New
York.
The State of New York 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: August 2, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-21264 Filed 8-25-95; 8:45 am]
BILLING CODE 4120-01-P