Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
Source: 63 FR 26732, May 14, 1998, unless otherwise noted.
Sec. 493.551 General requirements for laboratories.
(a) Applicability. CMS may deem a laboratory to meet all applicable
CLIA program requirements through accreditation by a private nonprofit
accreditation program (that is, grant deemed status), or may exempt from
CLIA program requirements all State licensed or approved laboratories in
a State that has a State licensure program established by law, if the
following conditions are met:
(1) The requirements of the accreditation organization or State
licensure program are equal to, or more stringent than, the CLIA
condition-level requirements specified in this part, and
[[Page 899]]
the laboratory would meet the condition-level requirements if it were
inspected against these requirements.
(2) The accreditation program or the State licensure program meets
the requirements of this subpart and is approved by CMS.
(3) The laboratory authorizes the approved accreditation
organization or State licensure program to release to CMS all records
and information required and permits inspections as outlined in this
part.
(b) Meeting CLIA requirements by accreditation. A laboratory seeking
to meet CLIA requirements through accreditation by an approved
accreditation organization must do the following:
(1) Obtain a certificate of accreditation as required in subpart D
of this part.
(2) Pay the applicable fees as required in subpart F of this part.
(3) Meet the proficiency testing (PT) requirements in subpart H of
this part.
(4) Authorize its PT organization to furnish to its accreditation
organization the results of the laboratory's participation in an
approved PT program for the purpose of monitoring the laboratory's PT
and for making the annual PT results, along with explanatory information
required to interpret the PT results, available on a reasonable basis,
upon request of any person. A laboratory that refuses to authorize
release of its PT results is no longer deemed to meet the condition-
level requirements and is subject to a full review by CMS, in
accordance with subpart Q of this part, and may be subject to the
suspension or revocation of its certificate of accreditation under
Sec. 493.1840.
(5) Authorize its accreditation organization to release to CMS or a
CMS agent the laboratory's PT results that constitute unsuccessful
participation in an approved PT program, in accordance with the
definition of ``unsuccessful participation in an approved PT program,''
as specified in Sec. 493.2 of this part, when the laboratory has failed
to achieve successful participation in an approved PT program.
(6) Authorize its accreditation organization to release to CMS a
notification of the actions taken by the organization as a result of the
unsuccessful participation in a PT program within 30 days of the
initiation of the action. Based on this notification, CMS may take an
adverse action against a laboratory that fails to participate
successfully in an approved PT program.
(c) Withdrawal of laboratory accreditation. After an accreditation
organization has withdrawn or revoked its accreditation of a laboratory,
the laboratory retains its certificate of accreditation for 45 days
after the laboratory receives notice of the withdrawal or revocation of
the accreditation, or the effective date of any action taken by CMS,
whichever is earlier.
Sec. 493.553 Approval process (application and reapplication) for
accreditation organizations and State licensure programs.
(a) Information required. An accreditation organization that applies
or reapplies to CMS for deeming authority, or a State licensure program
that applies or reapplies to CMS for exemption from CLIA program
requirements of licensed or approved laboratories within the State, must
provide the following information:
(1) A detailed comparison of the individual accreditation, or
licensure or approval requirements with the comparable condition-level
requirements; that is, a crosswalk.
(2) A detailed description of the inspection process, including the
following:
(i) Frequency of inspections.
(ii) Copies of inspection forms.
(iii) Instructions and guidelines.
(iv) A description of the review and decision-making process of
inspections.
(v) A statement concerning whether inspections are announced or
unannounced.
(vi) A description of the steps taken to monitor the correction of
deficiencies.
(3) A description of the process for monitoring PT performance,
including action to be taken in response to unsuccessful participation
in a CMS-approved PT program.
(4) Procedures for responding to and for the investigation of
complaints against its laboratories.
(5) A list of all its current laboratories and the expiration date
of their
[[Page 900]]
accreditation or licensure, as applicable.
(6) Procedures for making PT information available (under State
confidentiality and disclosure requirements, if applicable) including
explanatory information required to interpret PT results, on a
reasonable basis, upon request of any person.
(b) CMS action on an application or reapplication. If CMS receives
an application or reapplication from an accreditation organization, or
State licensure program, CMS takes the following actions:
(1) CMS determines if additional information is necessary to make a
determination for approval or denial of the application and notifies the
accreditation organization or State to afford it an opportunity to
provide the additional information.
(2) CMS may visit the accreditation organization or State licensure
program offices to review and verify the policies and procedures
represented in its application and other information, including, but not
limited to, review and examination of documents and interviews with
staff.
(3) CMS notifies the accreditation organization or State licensure
program indicating whether CMS approves or denies the request for
deeming authority or exemption, respectively, and the rationale for any
denial.
(c) Duration of approval. CMS approval may not exceed 6 years.
(d) Withdrawal of application. The accreditation organization or
State licensure program may withdraw its application at any time before
official notification, specified at Sec. 493.553(b)(3).
Sec. 493.555 Federal review of laboratory requirements.
CMS's review of an accreditation organization or State licensure
program includes, but is not limited to, an evaluation of the following:
(a) Whether the organization's or State's requirements for
laboratories are equal to, or more stringent than, the condition-level
requirements for laboratories.
(b) The organization's or State's inspection process to determine
the comparability of the full inspection and complaint inspection
procedures and requirements to those of CMS, including, but not limited
to, inspection frequency and the ability to investigate and respond to
complaints against its laboratories.
(c) The organization's or State's agreement with CMS that requires
it to do the following:
(1) Notify CMS within 30 days of the action taken, of any
laboratory that has--
(i) Had its accreditation or licensure suspended, withdrawn,
revoked, or limited;
(ii) In any way been sanctioned; or
(iii) Had any adverse action taken against it.
(2) Notify CMS within 10 days of any deficiency identified in an
accredited or CLIA-exempt laboratory if the deficiency poses an
immediate jeopardy to the laboratory's patients or a hazard to the
general public.
(3) Notify CMS, within 30 days, of all newly--
(i) Accredited laboratories (or laboratories whose areas of
specialty/subspecialty testing have changed); or
(ii) Licensed laboratories, including the specialty/subspecialty
areas of testing.
(4) Notify each accredited or licensed laboratory within 10 days of
CMS's withdrawal of the organization's deeming authority or State's
exemption.
(5) Provide CMS with inspection schedules, as requested, for
validation purposes.
Sec. 493.557 Additional submission requirements.
(a) Specific requirements for accreditation organizations. In
addition to the information specified in Secs. 493.553 and 493.555, as
part of the approval and review process, an accreditation organization
applying or reapplying for deeming authority must also provide the
following:
(1) The specialty or subspecialty areas for which the organization
is requesting deeming authority and its mechanism for monitoring
compliance with all requirements equivalent to condition-level
requirements within the scope of the specialty or subspecialty areas.
(2) A description of the organization's data management and analysis
system
[[Page 901]]
with respect to its inspection and accreditation decisions, including
the kinds of routine reports and tables generated by the systems.
(3) Detailed information concerning the inspection process,
including, but not limited to the following:
(i) The size and composition of individual accreditation inspection
teams.
(ii) Qualifications, education, and experience requirements that
inspectors must meet.
(iii) The content and frequency of training provided to inspection
personnel, including the ability of the organization to provide
continuing education and training to inspectors.
(4) Procedures for removal or withdrawal of accreditation status for
laboratories that fail to meet the organization's standards.
(5) A proposed agreement between CMS and the accreditation
organization with respect to the notification requirements specified in
Sec. 493.555(c).
(6) Procedures for monitoring laboratories found to be out of
compliance with its requirements. (These monitoring procedures must be
used only when the accreditation organization identifies noncompliance.
If noncompliance is identified through validation inspections, CMS or a
CMS agent monitors corrections, as authorized at Sec. 493.565(d)).
(7) A demonstration of its ability to provide CMS with electronic
data and reports in compatible code, including the crosswalk specified
in Sec. 493.553(a)(1), that are necessary for effective validation and
assessment of the organization's inspection process.
(8) A demonstration of its ability to provide CMS with electronic
data, in compatible code, related to the adverse actions resulting from
PT results constituting unsuccessful participation in PT programs as
well as data related to the PT failures, within 30 days of the
initiation of adverse action.
(9) A demonstration of its ability to provide CMS with electronic
data, in compatible code, for all accredited laboratories, including the
area of specialty or subspecialty.
(10) Information defining the adequacy of numbers of staff and other
resources.
(11) Information defining the organization's ability to provide
adequate funding for performing required inspections.
(12) Any facility-specific data, upon request by CMS, which
includes, but is not limited to, the following:
(i) PT results that constitute unsuccessful participation in a CMS-
approved PT program.
(ii) Notification of the adverse actions or corrective actions
imposed by the accreditation organization as a result of unsuccessful PT
participation.
(13) An agreement to provide written notification to CMS at least
30 days in advance of the effective date of any proposed change in its
requirements.
(14) An agreement to disclose any laboratory's PT results upon
reasonable request by any person.
(b) Specific requirements for a State licensure program. In addition
to requirements in Secs. 493.553 and 493.555, as part of the approval
and review process, when a State licensure program applies or reapplies
for exemption from the CLIA program, the State must do the following:
(1) Demonstrate to CMS that it has enforcement authority and
administrative structures and resources adequate to enforce its
laboratory requirements.
(2) Permit CMS or a CMS agent to inspect laboratories in the
State.
(3) Require laboratories in the State to submit to inspections by
CMS or a CMS agent as a condition of licensure or approval.
(4) Agree to pay the cost of the validation program administered in
that State as specified in Secs. 493.645(a) and 493.646(b).
(5) Take appropriate enforcement action against laboratories found
by CMS not to be in compliance with requirements equivalent to CLIA
requirements.
(6) Submit for Medicare and Medicaid payment purposes, a list of the
specialties and subspecialties of tests performed by each laboratory.
(7) Submit a written presentation that demonstrates the agency's
ability to furnish CMS with electronic data in compatible code,
including the crosswalk specified in Sec. 493.553(a)(1).
(8) Submit a statement acknowledging that the State will notify CMS
[[Page 902]]
through electronic transmission of the following:
(i) Any laboratory that has had its licensure or approval revoked or
withdrawn or has been in any way sanctioned by the State within 30 days
of taking the action.
(ii) Changes in licensure or inspection requirements.
(iii) Changes in specialties or subspecialties under which any
licensed laboratory in the State performs testing.
(9) Provide information for the review of the State's enforcement
procedures for laboratories found to be out of compliance with the
State's requirements.
(10) Submit information that demonstrates the ability of the State
to provide CMS with the following:
(i) Electronic data and reports in compatible code with the adverse
or corrective actions resulting from PT results that constitute
unsuccessful participation in PT programs.
(ii) Other data that CMS determines are necessary for validation
and assessment of the State's inspection process requirements.
(11) Agree to provide CMS with written notification of any changes
in its licensure/approval and inspection requirements.
(12) Agree to disclose any laboratory's PT results in accordance
with a State's confidentiality requirements.
(13) Agree to take the appropriate enforcement action against
laboratories found by CMS not to be in compliance with requirements
comparable to condition-level requirements and report these enforcement
actions to CMS.
(14) If approved, reapply to CMS every 2 years to renew its exempt
status and to renew its agreement to pay the cost of the CMS-
administered validation program in that State.
Sec. 493.559 Publication of approval of deeming authority or CLIA
exemption.
(a) Notice of deeming authority or exemption. CMS publishes a
notice in the Federal Register when it grants deeming authority to an
accreditation organization or exemption to a State licensure program.
(b) Contents of notice. The notice includes the following:
(1) The name of the accreditation organization or State licensure
program.
(2) For an accreditation organization:
(i) The specific specialty or subspecialty areas for which it is
granted deeming authority.
(ii) A description of how the accreditation organization provides
reasonable assurance to CMS that a laboratory accredited by the
organization meets CLIA requirements equivalent to those in this part
and would meet CLIA requirements if the laboratory had not been granted
deemed status, but had been inspected against condition-level
requirements.
(3) For a State licensure program, a description of how the
laboratory requirements of the State are equal to, or more stringent
than, those specified in this part.
(4) The basis for granting deeming authority or exemption.
(5) The term of approval, not to exceed 6 years.
Sec. 493.561 Denial of application or reapplication.
(a) Reconsideration of denial. (1) If CMS denies a request for
approval, an accreditation organization or State licensure program may
request, within 60 days of the notification of denial, that CMS
reconsider its original application or application for renewal, in
accordance with part 488, subpart D.
(2) If the accreditation organization or State licensure program
requests a reconsideration of CMS's determination to deny its request
for approval or reapproval, it may not submit a new application until
CMS issues a final reconsideration determination.
(b) Resubmittal of a request for approval-- accreditation
organization. An accreditation organization may resubmit a request for
approval if a final reconsideration determination is not pending and the
accreditation program meets the following conditions:
(1) It has revised its accreditation program to address the
rationale for denial of its previous request.
(2) It demonstrates that it can provide reasonable assurance that
its accredited facilities meet condition-level requirements.
[[Page 903]]
(3) It resubmits the application in its entirety.
(c) Resubmittal of request for approval--State licensure program.
The State licensure program may resubmit a request for approval if a
final reconsideration determination is not pending and it has taken the
necessary action to address the rationale for any previous denial.
Sec. 493.563 Validation inspections--Basis and focus.
(a) Basis for validation inspection--(1) Laboratory with a
certificate of accreditation. (i) CMS or a CMS agent may conduct an
inspection of an accredited laboratory that has been issued a
certificate of accreditation on a representative sample basis or in
response to a substantial allegation of noncompliance.
(ii) CMS uses the results of these inspections to validate the
accreditation organization's accreditation process.
(2) Laboratory in a State with an approved State licensure program.
(i) CMS or a CMS agent may conduct an inspection of any laboratory in
a State with an approved State licensure program on a representative
sample basis or in response to a substantial allegation of
noncompliance.
(ii) The results of these inspections are used to validate the
appropriateness of the exemption of that State's licensed or approved
laboratories from CLIA program requirements.
(b) Validation inspection conducted on a representative sample
basis. (1) If CMS or a CMS agent conducts a validation inspection on a
representative sample basis, the inspection is comprehensive, addressing
all condition-level requirements, or it may be focused on a specific
condition-level requirement.
(2) The number of laboratories sampled is sufficient to allow a
reasonable estimate of the performance of the accreditation organization
or State.
(c) Validation inspection conducted in response to a substantial
allegation of noncompliance. (1) If CMS or a CMS agent conducts a
validation inspection in response to a substantial allegation of
noncompliance, the inspection focuses on any condition-level requirement
that CMS determines to be related to the allegation.
(2) If CMS or a CMS agent substantiates a deficiency and
determines that the laboratory is out of compliance with any condition-
level requirement, CMS or a CMS agent conducts a full CLIA inspection.
(d) Inspection of operations and offices. As part of the validation
review process, CMS may conduct an onsite inspection of the operations
and offices to verify the following:
(1) The accreditation organization's representations and to assess
the accreditation organization's compliance with its own policies and
procedures.
(2) The State's representations and to assess the State's compliance
with its own policies and procedures, including verification of State
enforcement actions taken on the basis of validation inspections
performed by CMS or a CMS agent.
(e) Onsite inspection of an accreditation organization. An onsite
inspection of an accreditation organization may include, but is not
limited to, the following:
(1) A review of documents.
(2) An audit of meetings concerning the accreditation process.
(3) Evaluation of accreditation inspection results and the
accreditation decision-making process.
(4) Interviews with the accreditation organization's staff.
(f) Onsite inspection of a State licensure program. An onsite
inspection of a State licensure program office may include, but is not
limited to, the following:
(1) A review of documents.
(2) An audit of meetings concerning the licensure or approval
process.
(3) Evaluation of State inspection results and the licensure or
approval decision-making process.
(4) Interviews with State employees.
Sec. 493.565 Selection for validation inspection--laboratory
responsibilities.
A laboratory selected for a validation inspection must do the
following:
(a) Authorize its accreditation organization or State licensure
program, as applicable, to release to CMS or a CMS agent, on a
confidential basis, a copy of the laboratory's most recent
[[Page 904]]
full, and any subsequent partial inspection.
(b) Authorize CMS or a CMS agent to conduct a validation
inspection.
(c) Provide CMS or a CMS agent with access to all facilities,
equipment, materials, records, and information that CMS or a CMS agent
determines have a bearing on whether the laboratory is being operated in
accordance with the requirements of this part, and permit CMS or a CMS
agent to copy material or require the laboratory to submit material.
(d) If the laboratory possesses a valid certificate of
accreditation, authorize CMS or a CMS agent to monitor the correction
of any deficiencies found through the validation inspection.
Sec. 493.567 Refusal to cooperate with validation inspection.
(a) Laboratory with a certificate of accreditation. (1) A laboratory
with a certificate of accreditation that refuses to cooperate with a
validation inspection by failing to comply with the requirements in
Sec. 493.565--
(i) Is subject to full review by CMS or a CMS agent, in accordance
with this part; and
(ii) May be subject to suspension, revocation, or limitation of its
certificate of accreditation under this part.
(2) A laboratory with a certificate of accreditation is again deemed
to meet the condition-level requirements by virtue of its accreditation
when the following conditions exist:
(i) The laboratory withdraws any prior refusal to authorize its
accreditation organization to release a copy of the laboratory's current
accreditation inspection, PT results, or notification of any adverse
actions resulting from PT failure.
(ii) The laboratory withdraws any prior refusal to allow a
validation inspection.
(iii) CMS finds that the laboratory meets all the condition-level
requirements.
(b) CLIA-exempt laboratory. If a CLIA-exempt laboratory fails to
comply with the requirements specified in Sec. 493.565, CMS notifies
the State of the laboratory's failure to meet the requirements.
Sec. 493.569 Consequences of a finding of noncompliance as a result of
a validation inspection.
(a) Laboratory with a certificate of accreditation. If a validation
inspection results in a finding that the accredited laboratory is out of
compliance with one or more condition-level requirements, the laboratory
is subject to--
(1) The same requirements and survey and enforcement processes
applied to laboratories that are not accredited and that are found out
of compliance following an inspection under this part; and
(2) Full review by CMS, in accordance with this part; that is, the
laboratory is subject to the principal and alternative sanctions in
Sec. 493.1806.
(b) CLIA-exempt laboratory. If a validation inspection results in a
finding that a CLIA-exempt laboratory is out of compliance with one or
more condition-level requirements, CMS directs the State to take
appropriate enforcement action.
Sec. 493.571 Disclosure of accreditation, State and CMS validation
inspection results.
(a) Accreditation organization inspection results. CMS may disclose
accreditation organization inspection results to the public only if the
results are related to an enforcement action taken by the Secretary.
(b) State inspection results. Disclosure of State inspection results
is the responsibility of the approved State licensure program, in
accordance with State law.
(c) CMS validation inspection results. CMS may disclose the
results of all validation inspections conducted by CMS or its agent.
Sec. 493.573 Continuing Federal oversight of private nonprofit
accreditation organizations and approved State licensure
programs.
(a) Comparability review. In addition to the initial review for
determining equivalency of specified organization or State requirements
to the comparable condition-level requirements, CMS reviews the
equivalency of requirements in the following cases:
(1) When CMS promulgates new condition-level requirements.
[[Page 905]]
(2) When CMS identifies an accreditation organization or a State
licensure program whose requirements are no longer equal to, or more
stringent than, condition-level requirements.
(3) When an accreditation organization or State licensure program
adopts new requirements.
(4) When an accreditation organization or State licensure program
adopts changes to its inspection process, as required by
Sec. 493.575(b)(1), as applicable.
(5) Every 6 years, or sooner if CMS determines an earlier review is
required.
(b) Validation review. Following the end of a validation review
period, CMS evaluates the validation inspection results for each
approved accreditation organization and State licensure program.
(c) Reapplication procedures. (1) Every 6 years, or sooner, as
determined by CMS, an approved accreditation organization must reapply
for continued approval of deeming authority and a State licensure
program must reapply for continued approval of a CLIA exemption. CMS
provides notice of the materials that must be submitted as part of the
reapplication procedure.
(2) An accreditation organization or State licensure program that
does not meet the requirements of this subpart, as determined through a
comparability or validation review, must furnish CMS, upon request,
with the reapplication materials CMS requests. CMS establishes a
deadline by which the materials must be submitted.
(d) Notice. (1) CMS provides written notice, as appropriate, to the
following:
(i) An accreditation organization indicating that its approval may
be in jeopardy if a comparability or validation review reveals that it
is not meeting the requirements of this subpart and CMS is initiating a
review of the accreditation organization's deeming authority.
(ii) A State licensure program indicating that its CLIA exemption
may be in jeopardy if a comparability or validation review reveals that
it is not meeting the requirements of this subpart and that a review is
being initiated of the CLIA exemption of the State's laboratories.
(2) The notice contains the following information:
(i) A statement of the discrepancies that were found as well as
other related documentation.
(ii) An explanation of CMS's review process on which the final
determination is based and a description of the possible actions, as
specified in Sec. 493.575, that CMS may impose based on the findings
from the comparability or validation review.
(iii) A description of the procedures available if the accreditation
organization or State licensure program, as applicable, desires an
opportunity to explain or justify the findings made during the
comparability or validation review.
(iv) The reapplication materials that the accreditation organization
or State licensure program must submit and the deadline for that
submission.
Sec. 493.575 Removal of deeming authority or CLIA exemption and final
determination review.
(a) CMS review. CMS conducts a review of the following:
(1) A deeming authority review of an accreditation organization's
program if the comparability or validation review produces findings, as
described at Sec. 493.573. CMS reviews, as appropriate, the criteria
described in Secs. 493.555 and 493.557(a) to reevaluate whether the
accreditation organization continues to meet all these criteria.
(2) An exemption review of a State's licensure program if the
comparability or validation review produces findings, as described at
Sec. 493.573. CMS reviews, as appropriate, the criteria described in
Secs. 493.555 and 493.557(b) to reevaluate whether the licensure program
continues to meet all these criteria.
(3) A review of an accreditation organization or State licensure
program, at CMS's discretion, if validation review findings,
irrespective of the rate of disparity, indicate widespread or systematic
problems in the organization's accreditation or State's licensure
process that provide evidence that the requirements, taken as a whole,
are no longer equivalent to CLIA requirements, taken as a whole.
(4) A review of the accreditation organization or State licensure
program
[[Page 906]]
whenever validation inspection results indicate a rate of disparity of
20 percent or more between the findings of the organization or State and
those of CMS or a CMS agent for the following periods:
(i) One year for accreditation organizations.
(ii) Two years for State licensure programs.
(b) CMS action after review. Following the review, CMS may take
the following action:
(1) If CMS determines that the accreditation organization or State
has failed to adopt requirements equal to, or more stringent than, CLIA
requirements, CMS may give a conditional approval for a probationary
period of its deeming authority to an organization 30 days following the
date of CMS's determination, or exempt status to a State within 30 days
of CMS's determination, both not to exceed 1 year, to afford the
organization or State an opportunity to adopt equal or more stringent
requirements.
(2) If CMS determines that there are widespread or systematic
problems in the organization's or State's inspection process, CMS may
give conditional approval during a probationary period, not to exceed 1
year, effective 30 days following the date of the determination.
(c) Final determination. CMS makes a final determination as to
whether the organization or State continues to meet the criteria
described in this subpart and issues a notice that includes the reasons
for the determination to the organization or State within 60 days after
the end of any probationary period. This determination is based on an
evaluation of any of the following:
(1) The most recent validation inspection and review findings. To
continue to be approved, the organization or State must meet the
criteria of this subpart.
(2) Facility-specific data, as well as other related information.
(3) The organization's or State's inspection procedures, surveyors'
qualifications, ongoing education, training, and composition of
inspection teams.
(4) The organization's accreditation requirements, or the State's
licensure or approval requirements.
(d) Date of withdrawal of approval. CMS may withdraw its approval
of the accreditation organization or State licensure program, effective
30 days from the date of written notice to the organization or State of
this proposed action, if improvements acceptable to CMS have not been
made during the probationary period.
(e) Continuation of validation inspections. The existence of any
validation review, probationary status, or any other action, such as a
deeming authority review, by CMS does not affect or limit the conduct
of any validation inspection.
(f) Federal Register notice. CMS publishes a notice in the Federal
Register containing a justification for removing the deeming authority
from an accreditation organization, or the CLIA-exempt status of a State
licensure program.
(g) Withdrawal of approval-effect on laboratory status--(1)
Accredited laboratory. After CMS withdraws approval of an accreditation
organization's deeming authority, the certificate of accreditation of
each affected laboratory continues in effect for 60 days after it
receives notification of the withdrawal of approval.
(2) CLIA-exempt laboratory. After CMS withdraws approval of a State
licensure program, the exempt status of each licensed or approved
laboratory in the State continues in effect for 60 days after a
laboratory receives notification from the State of the withdrawal of
CMS's approval of the program.
(3) Extension. After CMS withdraws approval of an accreditation
organization or State licensure program, CMS may extend the period for
an additional 60 days for a laboratory if it determines that the
laboratory submitted an application for accreditation to an approved
accreditation organization or an application for the appropriate
certificate to CMS or a CMS agent before the initial 60-day period
ends.
(h) Immediate jeopardy to patients. (1) If at any time CMS
determines that the continued approval of deeming authority of any
accreditation organization poses immediate jeopardy to the patients of
the laboratories accredited
[[Page 907]]
by the organization, or continued approval otherwise constitutes a
significant hazard to the public health, CMS may immediately withdraw
the approval of deeming authority for that accreditation organization.
(2) If at any time CMS determines that the continued approval of a
State licensure program poses immediate jeopardy to the patients of the
laboratories in that State, or continued approval otherwise constitutes
a significant hazard to the public health, CMS may immediately withdraw
the approval of that State licensure program.
(i) Failure to pay fees. CMS withdraws the approval of a State
licensure program if the State fails to pay the applicable fees, as
specified in Secs. 493.645(a) and 493.646(b).
(j) State refusal to take enforcement action. (1) CMS may withdraw
approval of a State licensure program if the State refuses to take
enforcement action against a laboratory in that State when CMS
determines it to be necessary.
(2) A laboratory that is in a State in which CMS has withdrawn
program approval is subject to the same requirements and survey and
enforcement processes that are applied to a laboratory that is not
exempt from CLIA requirements.
(k) Request for reconsideration. Any accreditation organization or
State that is dissatisfied with a determination to withdraw approval of
its deeming authority or remove approval of its State licensure program,
as applicable, may request that CMS reconsider the determination, in
accordance with subpart D of part 488.
|