[Federal Register Volume 65, Number 211 (Tuesday, October 31, 2000)]
[Notices]
[Pages 64966-64968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27956]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

[HCFA-2118-N]


Medicare, Medicaid, and CLIA Programs; Continuance of the 
Approval of COLA as a CLIA Accreditation Organization

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the continued approval of COLA (formerly 
the Commission on Office Laboratory Accreditation) as an accreditation 
organization for laboratories under the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) program. We have found that the accreditation 
process of this organization provides reasonable assurance that the 
laboratories accredited by it meet the conditions required by CLIA law 
and regulations. Consequently, laboratories that voluntarily become 
accredited by COLA in lieu of direct Federal oversight and continue to 
meet COLA requirements would meet the CLIA condition level requirements 
for laboratories and, therefore, are not subject to routine inspection 
by State survey agencies to determine their compliance with CLIA 
requirements. They are, however, subject to Federal validation and 
complaint investigation surveys.

EFFECTIVE DATE: This notice is effective for the period October 31, 
2000, through December 31, 2002.

FOR FURTHER INFORMATION CONTACT: Val Coppola, (410) 786-3531.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative Authority

    On July 31, 1992, HCFA issued a final rule (57 FR 33992). Under 
section 353(e)(2) of the Public Health Service Act (PHSA), HCFA may 
approve a private, nonprofit organization to accredit clinical 
laboratories (an ``approved accreditation organization'') under the 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) program if 
the organization meets certain requirements. An organization's 
requirements for accredited laboratories must be equal to, or more 
stringent than, the applicable CLIA program requirements in 42 Code of 
Federal Regulations (CFR), part 493 (Laboratory Requirements). 
Therefore, a laboratory accredited by an approved accreditation 
organization that meets and continues to meet all of the accreditation 
organization's requirements would be considered to meet CLIA condition 
level requirements if it were inspected against CLIA regulations. The 
regulations listed in subpart E (Accreditation by a Private, Nonprofit 
Accreditation Organization or Exemption Under an Approved State 
Laboratory Program) of part 493 specify the requirements an 
accreditation organization must meet to be an approved accreditation 
organization. HCFA approves an accreditation organization for a period 
not to exceed 6 years.
    In general, the approved accreditation organization must among 
other conditions and requirements:
    <bullet> Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories with the frequency 
determined by HCFA.
    <bullet> Apply standards and criteria that are equal to or more 
stringent than those condition level requirements established by HCFA 
when taken as a whole.
    <bullet> Provide reasonable assurance that these standards and 
criteria are continually met by its accredited laboratories;
    <bullet> Provide HCFA with the name of any laboratory that has had 
its accreditation denied, suspended, withdrawn, limited, or revoked 
within 30 days of the action taken.
    <bullet> Notify HCFA in writing at least 30 days before the 
effective date of any proposed changes in its standards.
    <bullet> If HCFA withdraws its approval, notify the accredited 
laboratories of the withdrawal within 10 days of the withdrawal. A 
laboratory can be accredited if, among other things, it meets the 
standards of an approved accreditation organization and authorizes the 
accreditation body to submit to HCFA records and other information HCFA 
may require.
    Along with requiring the promulgation of criteria for approving the 
accreditation body and for withdrawing this approval, CLIA requires 
HCFA to perform an annual evaluation by inspecting a sufficient number 
of laboratories accredited by an approved accreditation organization as 
well as by any other means that HCFA determines appropriate.

II. Notice of Continued Approval of COLA as an Accreditation 
Organization

    In this notice, we approve COLA as an organization that may 
continue to accredit laboratories for purposes of establishing their 
compliance with CLIA requirements. HCFA and Centers for Disease Control 
and Prevention (CDC) have examined the COLA application and all 
subsequent submissions to determine equivalency with HCFA requirements 
under subpart E of part 493 that an accreditation organization must 
meet to be granted approved status under CLIA. We have determined that 
COLA has complied with the applicable CLIA requirements as of October 
31, 2000, and grant COLA approval as an accreditation organization 
under subpart E, through August 31, 2002, for the following specialty/
subspecialty areas:

<bullet> Bacteriology.
<bullet> Mycobacteriology.
<bullet> Mycology.
<bullet> Parasitology.
<bullet> Virology.
<bullet> Syphilis Serology.
<bullet> General Immunology.
<bullet> Routine Chemistry.
<bullet> Endocrinology.
<bullet> Toxicology.
<bullet> Urinalysis.
<bullet> Hematology.
<bullet> Immunohematology.

    As a result of this determination, any laboratory that is 
accredited by COLA during this time period for an approved specialty/
subspecialty (listed above) is deemed to meet the applicable CLIA 
condition level requirements for the laboratories found in part 493 
and, therefore, is not subject to routine inspection by a State survey 
agency to determine its compliance with CLIA requirements. The 
accredited laboratory, however, is subject to validation and complaint 
investigation surveys performed by HCFA, or by any other Federal or 
State or local public agency or nonprofit private organization under an 
agreement with the Secretary.

III. Evaluation of COLA

    The following describes the process used to determine that COLA, as 
a private, nonprofit organization, provides reasonable assurance that 
laboratories it accredits will meet the applicable requirements of the 
CLIA and applicable regulations.

[[Page 64967]]

A. Requirements for Approving an Accreditation Organization Under CLIA

    To determine whether we should grant approved status to COLA as a 
private, nonprofit organization for accrediting laboratories under CLIA 
for the specific specialty or subspecialty areas of human specimen 
testing it requested, we conducted a detailed and in-depth comparison 
of COLA's requirements for its laboratories to those of CLIA. In 
summary, we evaluated whether COLA meets the following requirements:
    <bullet> Provides reasonable assurance to us that it requires the 
laboratories it accredits to meet requirements that are equal to or 
more stringent than the CLIA condition level requirements (for the 
requested specialties/subspecialties) and would, therefore, meet the 
condition level requirements of CLIA if those laboratories had not been 
granted deemed status and had been inspected against condition level 
requirements.
    <bullet> Meets the applicable requirements of Subpart E.
    As specified in the regulations of subpart E, HCFA review of a 
private, nonprofit accreditation organization seeking approved status 
under CLIA includes, but is not limited to, an evaluation of the 
following:
    <bullet> Whether the organization's requirements for its accredited 
laboratories are equal to or more stringent than the condition level 
requirements of the CLIA regulations.
    <bullet> The organization's inspection process to determine:

--The composition of the inspection teams, qualifications of the 
inspectors, and the ability of the organization to provide continuing 
education and training to all of its inspectors;
--The comparability of the organization's full inspection and complaint 
inspection requirements to the Federal requirements including but not 
limited to inspection frequency, and the ability to investigate and 
respond to complaints against its accredited laboratories.
--The organization's procedures for monitoring laboratories that it has 
found to be out of compliance with its requirements.
--The ability of the organization to provide HCFA with electronic data 
and reports that are necessary for effective validation and assessment 
of the organization's inspection process.
--The ability of the organization to provide HCFA with electronic data, 
related to the adverse actions resulting from unsuccessful proficiency 
testing (PT) participation in HCFA approved PT programs, as well as 
data related to the PT failures, within 30 days of the initiation of 
the action.
--The ability of the organization to provide HCFA with electronic data 
for all its accredited laboratories and the areas of specialty and 
subspecialty testing.
--The adequacy of the numbers of staff and other resources.
--The organization's ability to provide adequate funding for performing 
the required inspections.

    <bullet> The organization's agreement with HCFA that requires it, 
among other things, to meet the following requirements:

--Notify HCFA of any laboratory that has had its accreditation denied, 
limited, suspended, withdrawn, or revoked by the accreditation 
organization, or that has had any other adverse action taken against it 
by the accreditation organization within 30 days of the action taken.
--Notify HCFA within 10 days of a deficiency identified in an 
accredited laboratory if the deficiency poses an immediate jeopardy to 
the laboratory's patients or a hazard to the general public.
--Notify HCFA of all newly accredited laboratories, or laboratories 
whose areas of specialty or subspecialty are revised, within 30 days.
--Notify each laboratory accredited by the organization within 10 days 
of HCFA's withdrawal of approval of the organization.
--Provide HCFA with inspection schedules, as requested, for the purpose 
of conducting onsite validation inspections.
--Provide HCFA or our agent, or the State survey agency with any 
facility-specific data that includes, but is not limited to, PT results 
that constitute unsuccessful participation in an approved PT program 
and notification of the adverse actions or corrective actions imposed 
by the accreditation organization as a result of unsuccessful PT 
participation.
--Provide HCFA with written notification at least 30 days in advance of 
the effective date of any proposed changes in its requirements.
--Provide upon the request by any person, on a reasonable basis (under 
State confidentiality and disclosure requirements, if applicable), any 
laboratory's PT results with the explanatory information needed to 
assist in the interpretation of the results.

    Laboratories that are accredited by an approved accreditation 
organization must, among other things, meet the following requirements:
    <bullet> Authorize the organization to release to HCFA all records 
and information required.
    <bullet> Permit inspections as required by the CLIA regulations in 
part 493, subpart Q (Inspection).
    <bullet> Obtain a certificate of accreditation as required by 
Sec. 493.55 (Application for registration certificate and certificate 
of accreditation).

B. Evaluation of the COLA Request for Continued Approval as an 
Accreditation Organization under CLIA

    HCFA has verified COLA's assurance that it requires the 
laboratories it accredits to be, and that the organization is, in 
compliance with the following subparts of part 493 as explained below:
Subpart E--Accreditation by a Private, Nonprofit Accreditation 
Organization or Exemption Under an Approved State Laboratory Program
    COLA has submitted a list of the specialties and subspecialties 
that it would continue to accredit, a description of its inspection 
process and guidelines, PT monitoring process, and its data management 
and analysis system, a listing of the size, composition, education and 
experience of its inspection teams, its investigative and complaint 
response procedures, its notification agreements with HCFA, its removal 
or withdrawal of laboratory accreditation procedures, its current list 
of accredited laboratories, and its announced or unannounced inspection 
process. We have determined that COLA has complied with the 
requirements under CLIA for approval as an accreditation organization 
under this subpart.
Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Tests of Moderate or High Complexity, or Both
    COLA's requirements for PT are equivalent to those of CLIA.
Subpart J--Patient Test Management for Moderate or High Complexity 
Testing, or Both
    COLA has revised its requirements to equal the CLIA requirements at 
Secs. 493.1101 through 493.1111 on an overall basis.
Subpart K--Quality Control for Tests of Moderate or High Complexity, or 
Both
    The quality control (QC) requirements of COLA have been evaluated 
against the applicable requirements of CLIA and its implementing 
regulations. We have determined that COLA's requirements, when taken as 
a whole, are equal to or

[[Page 64968]]

more stringent than the CLIA requirements.
Subpart M--Personnel for Moderate and High Complexity Testing
    We have found the COLA personnel requirements to be equal to the 
CLIA personnel requirements.
Subpart P--Quality Assurance for Moderate or High Complexity Testing or 
Both
    We have determined that COLA's requirements are equal to the CLIA 
requirements of this subpart.
Subpart Q--Inspections
    We have determined that COLA's inspection requirements are equal to 
the requirements of this subpart.
Subpart R--Enforcement Procedures for Laboratories
    COLA meets the requirements of subpart R to the extent it applies 
to accreditation organizations. COLA policy stipulates the action it 
takes when laboratories it accredits do not comply with its 
requirements. COLA shall suspend, withdraw, revoke, or limit 
accreditation of a laboratory as appropriate and report the action to 
HCFA within 30 days. COLA also provides an appeals process for 
laboratories that have had accreditation denied.
    We have determined that COLA's laboratory enforcement and appeal 
policies are essentially equivalent to the requirements of this subpart 
as they apply to accreditation organizations.

IV. Federal Validation Inspections and Continuing Oversight

    The Federal validation inspections of COLA accredited laboratories 
may be conducted on a representative sample basis or in response to 
substantial allegations of noncompliance (complaint inspections). The 
outcome of those validation inspections, performed by HCFA or our 
agent, or the State survey agency, will be HCFA's principal means for 
verifying that the laboratories accredited by COLA remain in compliance 
with CLIA requirements. This Federal monitoring is an ongoing process.

V. Removal of Approval as an Accrediting Organization

    Our regulations provide that we may remove the approval of an 
accreditation organization, such as that of COLA, for cause, before the 
end of the effective date of approval. If validation inspection 
outcomes and the comparability or validation review produce findings as 
described in Sec. 493.573 (Continuing Federal oversight of private 
nonprofit accreditation organizations and approved State licensure 
program), HCFA will conduct a review of an approved accreditation 
organization's program. We also conduct a review when the validation 
review findings, irrespective of the rate of disparity (as defined in 
Sec. 493.2), indicate systemic problems in the organization's processes 
that provide evidence that the organization's requirements, taken as a 
whole, are no longer equivalent to the CLIA requirements, taken as a 
whole.
    If HCFA determines that COLA has failed to adopt or maintain 
requirements that are equal to or more stringent than the CLIA 
requirements, or systemic problems exist in its inspection process, a 
probationary period, not to exceed 1 year, may be given to COLA to 
adopt equal or more stringent requirements. HCFA will make a 
determination as to whether or not COLA retains its approved status as 
an accreditation organization under CLIA. If approved status is 
withdrawn, an accreditation organization such as COLA may resubmit its 
application if it revises its program to address the rationale for the 
denial, demonstrates that it can reasonably assure that its accredited 
laboratories meet CLIA condition level requirements, and resubmits its 
application for approval as an accreditation organization in its 
entirety. If, however, an approved accreditation organization requests 
reconsideration of an adverse determination in accordance with subpart 
D (Reconsideration of Adverse Determinations--Deeming Authority for 
Accreditation Organizations and CLIA Exemption of Laboratories Under 
State Programs) of part 488 (Survey, Certification, and Enforcement 
Procedures) of our regulations, it may not submit a new application 
until HCFA issues a final reconsideration determination.
    Should circumstances result in COLA having its approval withdrawn, 
HCFA will publish a notice in the Federal Register explaining the basis 
for removing its approval.

    Authority: Section 353 of the Public Health Service Act (42 
U.S.C. 263a).

    Dated: September 18, 2000.
Nancy-Ann Min-DeParle,
Administrator, Health Care Financing Administration.
[FR Doc. 00-27956 Filed 10-30-00; 8:45 am]
BILLING CODE 4120-01-P