[Federal Register: March 22, 2002 (Volume 67, Number 56)]
[Notices]               
[Page 13341-13344]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr02-73]                         


[[Page 13341]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2138-N]
RIN 0938-ZA28

 
Medicare, Medicaid, and CLIA Programs; Continuance of Approval of 
the American Osteopathic Association (AOA) as an CLIA Accreditation 
Organization

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the continued approval of the American 
Osteopathic Association (AOA) as an accreditation organization for 
clinical laboratories under the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) program. We have determined that the 
accreditation process of this organization provides reasonable 
assurance that the laboratories accredited by AOA meet the conditions 
required by CLIA statute and its implementing regulations. 
Consequently, laboratories that voluntarily become accredited by AOA, 
in lieu of direct Federal oversight, and continue to meet AOA 
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. However, these laboratories are subject to Federal 
validation and complaint investigation surveys.

EFFECTIVE DATE: This notice is effective for the period March 22, 2002 
through March 24, 2008.

FOR FURTHER INFORMATION CONTACT: Kathy Todd, (410) 786-3385.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative Authority

    On October 31, 1988, the Congress enacted the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA), Public Law 100-578. CLIA 
replaced in its entirety section 353(e)(2) of the Public Health Service 
Act, as enacted by the Clinical Laboratories Improvement Act of 1967. 
In the July 31, 1992 Federal Register (57 FR 33992), we issued a final 
rule implementing the accreditation provisions of CLIA. Under this 
rule, we may approve a private, nonprofit organization as an approved 
accreditation organization to accredit clinical laboratories under the 
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 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 in part 493, 
subpart E (Accreditation by a Private, Nonprofit Accreditation 
Organization or Exemption Under an Approved State Laboratory Program) 
specify the requirements an accreditation organization must meet in 
order to be an approved. We approve an accreditation organization for a 
period not to exceed 6 years.
    In general, the approved accreditation organization must, among 
other conditions and requirements:
     Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories with the frequency 
determined by us.
     Apply standards and criteria that are equal to, or more 
stringent than, those condition level requirements established by us 
when taken as a whole.
     Provide reasonable assurance that these standards and 
criteria are continuously met by its accredited laboratories.
     Provide us with the name of any laboratory that has had 
its accreditation denied, suspended, withdrawn, limited, or revoked 
within 30 days of the action taken.
     Notify us at least 30 days before implementing any 
proposed changes in its standards.
     If we withdraw our 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 organization to submit records and other information to 
us as required.
    In addition to requiring the promulgation of criteria for approving 
an accreditation organization and withdrawing this approval, CLIA 
regulations require us 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 we 
determine appropriate.

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

    In this notice, we approve AOA as an organization that may continue 
to accredit laboratories for purposes of establishing their compliance 
with CLIA. The Centers for Disease Control and Prevention (CDC) and CMS 
have examined the AOA application and all subsequent submissions to 
determine equivalency with the requirements under 42 CFR part 493, 
subpart E that an accreditation organization must meet to be granted 
approved status under CLIA. We have determined that AOA complied with 
the applicable CLIA requirements and grant AOA approval as an 
accreditation organization under 42 CFR part 493, subpart E, as of 
March 21, 2002 through March 24, 2002 for all specialty and 
subspecialty areas under CLIA.
    As a result of this determination, any laboratory that is 
accredited by AOA during this time period for an approved specialty or 
subspecialty 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 CMS, or by any other Federal State, local public agency, 
or nonprofit organization under an agreement with the Secretary.

III. Evaluation of American Osteopathic Association (AOA)

    The following describes the process used to determine that the 
American Osteopathic Association (AOA), as a private, nonprofit 
organization, provides reasonable assurance that laboratories it 
accredits will meet the applicable requirements of CLIA.

A. Requirements for Approving an Accreditation

Organization Under CLIA
    To determine whether we should grant approved status to AOA as a 
private, nonprofit organization for accrediting laboratories under CLIA 
for all specialty or subspecialty areas of human specimen testing it 
requested, we conducted a detailed and in-depth comparison of AOA's 
requirements for its laboratories to those of CLIA. In summary, we 
evaluated whether AOA meets the following requirements:
     Provides reasonable assurance to us that it requires the 
laboratories it accredits to meet requirements that are equal to, or 
more stringent than, the

[[Page 13342]]

CLIA condition level requirements (for the requested specialties and 
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.
     Meets the applicable requirements of part 493, subpart E.
    As specified in the regulations of part 493, subpart E, the review 
of a private, nonprofit accreditation organization seeking approved 
status under CLIA includes, but is not limited to, an evaluation of the 
following:
     Whether the organization's requirements for its accredited 
laboratories are equal to, or more stringent than, the condition levels 
requirements of the CLIA regulations.
     The organization's inspection process to determine the 
following:
    + 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 us 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 us with electronic 
data related to the adverse actions resulting from unsuccessful 
proficiency testing (PT) participation in CMS-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 us with electronic 
data for all its accredited laboratories and the area 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.
     Whether the organization has an agreement with us that 
requires it, among other things, to meet the following:
    + Notify us 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 date the 
action is taken.
    + Notify us 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 us 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 our withdrawal of approval of the organization as an 
accreditation organization.
    + Provide us with inspection schedules, on request, for the purpose 
of conducting onsite validation inspections.
    + Provide our agent, the State survey agency, or CMS with any 
facility-specific data that include, but are 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 us 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:
     Authorize the organization to release to us all records 
and information required.
     Permit inspections as required by the CLIA regulations at 
part 493, subpart Q (Inspection).
     Obtain a certificate of accreditation under Sec. 493.55 
(Application for registration certificate and certificate of 
accreditation).

B. Evaluation of the AOA Request for Continued Approval as an 
Accreditation Organization Under CLIA

    We have examined AOA'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: 1. Subpart E--Accreditation by a 
Private, Nonprofit Accreditation Organization or Exemption Under an 
Approved State Laboratory Program
    AOA has requested continued approval to accredit all specialties 
and subspecialties and has submitted the following:
     Description of its PT monitoring process, inspection 
processes, policies, and data management and analysis system.
     List of its inspection team size, composition, and 
education and experience.
     Investigative and complaint response procedures.
     Our notification agreements.
     Procedures for the removal or withdrawal of accreditation 
from a laboratory.
     Current list of accredited laboratories with announced or 
unannounced inspection process.
    We have determined that AOA has complied with the requirements 
under CLIA for approval as an accreditation organization under this 
subpart.
    Our evaluation identified several areas of AOA requirements that 
are more stringent that the CLIA requirements and apply to the 
laboratory when taken as a whole. Rather than include them in the 
appropriate subparts multiple times, we have listed them here:
     AOA lists extensive requirements for the laboratory 
information system (LIS) that include but are not limited to the 
following:
    + The laboratory must ensure that test results generated by the LIS 
are reported, archived and maintained in an accurate and reliable 
manner.
    + The laboratory must perform and document the necessary system 
maintenance required by the LIS manufacturer or established by and 
validated by the laboratory.
    + All input/output devices must be maintained to ensure accurate, 
clear, and interference-free transmission of reports.
    + The laboratory must validate new or revised software and/or 
hardware before their use.
    + LIS access must be used to limit access to only those functions 
the personnel are authorized to use.
    plus The LIS must be protected against power and electrical 
interruptions.
    + The laboratory must validate and have records of that validation 
for all calculations performed by the LIS at least twice a year or as 
specified by the manufacturer.
     AOA requires the establishment of protocols to protect the 
confidentiality of patient-identified information and

[[Page 13343]]

considers all patient identified information received or generated in 
the laboratory as confidential information that must be so defined in 
laboratory protocols for employees and agents of the laboratory who 
have knowledge of test results.
     AOA has specific requirements for autopsy pathology that 
include but are not limited to the following:
    + Clinical records are reviewed with the attending physician before 
conducting the autopsy.
    + Written policies and procedures for the storage and release of 
bodies must be available and followed.
    + Written policies and procedures for the autopsy consent must be 
available and followed.
    + Autopsy policies and procedures must be available at nursing 
stations, admitting office and other appropriate places.
    + Requirements for autopsy pathology environmental conditions, 
equipment, materials and supplies.
    + Requirements for autopsy pathology safety.
    + Requirements for autopsy pathology reports.
    2. Subpart H (regarding participation in proficiency testing)
    AOA's requirements for PT are equivalent to those of CLIA.
    3. Subpart J (regarding patient test management)
    AOA's requirements in patient test management are equivalent to 
those of CLIA.
    4. Subpart K (regarding quality control)
    The quality control (QC) requirements of AOA have been evaluated 
against the applicable requirements of CLIA and its implementing 
regulations. We have determined that AOA's requirements, when taken as 
a whole, are more stringent than the CLIA requirements. Specifically, 
the AOA has laboratory safety requirements that are specific and 
detailed. AOA requires laboratories to have an appointed safety officer 
and maintain quarterly written safety reports. AOA also has 
requirements for fire safety and prevention of fire hazards, universal 
precautions, hazardous waste management, and environmental safety 
requirements to address electrical grounding and emergency power.
    5. Subpart M (regarding personnel)
    We have found that AOA's personnel requirements, when taken as a 
whole, are equal to the CLIA requirements.
    6. Subpart P (regarding quality assurance)
    We have determined that AOA's requirements are equal to the CLIA 
requirements of this subpart. AOA has adopted the CLIA quality 
assurance requirements in their entirety and included them in AOA's 
checklist.
    7. Subpart Q--Inspections
    AOA will continue to perform on-site inspections on a biennial 
basis. Therefore, we have determined that AOA's inspections are 
equivalent to CLIA.
    8. Subpart R--Enforcement
    AOA meets the requirements of subpart R to the extent that it 
applies to accreditation organizations. AOA policy stipulates the 
action it takes when laboratories it accredits do not comply with its 
requirements. AOA must deny, revoke, or limit accreditation of a 
laboratory as appropriate and report the action to us within 30 days. 
AOA also provides an appeal process for laboratories that have had 
accreditation denied, revoked, suspended, or limited.
    We have determined that AOA's laboratory enforcement and appeal 
policies are 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 AOA-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 our agent, or the 
State survey agency, or us, will be our principal means for verifying 
that the laboratories accredited by AOA remain in compliance with CLIA 
requirements. This Federal monitoring is an ongoing process.

V. Removal of Approval as an Accrediting Organization

    Our regulations provide, in part, that we may remove the approval 
of an accreditation organization, such as that of AOA, 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 programs), we will conduct a review of an approved 
accreditation organization's program. In addition, we will conduct a 
review, when the validation review findings, irrespective of the rate 
of disparity (as defined in Sec. 493.2), indicate widespread or 
systemic problems in the organization's accreditation 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 validation inspection results over a 1-year period indicate a 
rate of disparity of 20 percent or more between our findings and those 
of the organization, we will conduct a review under Sec. 493.575(a)(4).
    If we determine that AOA has failed to adopt or maintain 
requirements that are equal to, or more stringent than the CLIA 
requirements, or systematic problems exist in its inspection process, a 
probationary period as determined by us, not to exceed 1 year, may be 
given to AOA to adopt equal or more stringent requirements. We will 
make a final determination as to whether or not AOA retains its 
approved status as an accreditation organization under CLIA. If 
approved status is withdrawn, an accreditation organization such as AOA 
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. However, if 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 we issue a final 
reconsideration determination. Should circumstances result in AOA 
having its approval withdrawn, we will publish a notice in the Federal 
Register explaining the basis for removing its approval.

VI. Federalism

    We have reviewed this notice under the threshold criteria of 
Executive Order 13132, Federalism, and have determined that this notice 
will not have any negative impact on the rights, roles, and 
responsibilities of State, local, or tribal governments.

VII. OMB Review

    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget did not review this notice.

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


[[Page 13344]]


    Dated: January 15, 2002.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 02-6953 Filed 3-21-02; 8:45 am]
BILLING CODE 4120-01-P