[Federal Register: May 14, 1998 (Volume 63, Number 93)]
[Rules and Regulations]
[Page 26722-26738]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my98-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
Centers for Disease Control and Prevention
42 CFR Part 493
[HCFA-2239-F]
RIN 0938-AH82
CLIA Program; Simplifying CLIA Regulations Relating to
Accreditation, Exemption of Laboratories Under a State Licensure
Program, Proficiency Testing, and Inspection
AGENCY: Health Care Financing Administration (HCFA), and Centers for
Disease Control and Prevention (CDC), HHS.
ACTION: Final rule.
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SUMMARY: This final rule responds to selected comments received on a
final rule with a comment period implementing the Clinical Laboratory
Improvement Amendments of 1988, which was published in the Federal
Register on February 28, 1992, in the areas of proficiency testing and
inspections for clinical laboratories. In responding to these comments,
we accommodate, when possible, the Administration's regulatory reform
initiative by reducing duplicative material, emphasizing outcome-
oriented results, and simplifying regulations. In that regard, we also
are streamlining our regulations in the areas of State exemption, and
granting deemed status to laboratories accredited by an approved
accreditation organization.
EFFECTIVE DATE: These regulations are effective on June 15, 1998.
Copies: To order copies of the Federal Register containing this
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This Federal Register document is also available from the Federal
Register
[[Page 26723]]
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FOR FURTHER INFORMATION CONTACT: Judy Yost, (410) 786-3531.
SUPPLEMENTARY INFORMATION:
I. Background
On February 28, 1992, we published in the Federal Register, at 57
FR 7002, final regulations with an opportunity for public comment,
``Regulations Implementing the Clinical Laboratory Improvement
Amendments of 1988 (CLIA),'' that set forth requirements for
laboratories that are subject to CLIA. CLIA requirements apply to any
laboratory that examines human specimens for the diagnosis, prevention,
or treatment of any disease or impairment of, or the assessment of the
health of, human beings. The regulations at 42 CFR part 493 establish
uniform requirements for all laboratories regardless of location, size,
or type. A laboratory must meet these Federal requirements, or a
laboratory may meet the requirements if it is either accredited by a
private, nonprofit accreditation organization approved by HCFA, and
holds a valid CLIA certificate, or it is located in a State that HCFA
has granted an exemption from CLIA requirements because the State has
in effect laws that provide for requirements equal to or more stringent
than CLIA requirements.
On July 31, 1992, we published in the Federal Register, at 57 FR
33992, a final rule that established the criteria used to approve
accreditation organizations and State licensure programs. These
regulations are found in subpart E of part 493 and are based on
statutory requirements in section 353 (e) and (p) of the Public Health
Service Act.
II. Provisions of the Final Regulations
These regulations respond to public comments received on the
February 28, 1992 rule concerning the inspection of laboratories and
the regulatory use of proficiency testing. In responding to the
concerns of the commenters, we accommodate, whenever possible, the
Administration's regulatory reform commitment by:
(1) Eliminating duplicative material and reorganizing regulations
concerning accreditation by a private, nonprofit accreditation
organization and exemption from CLIA requirements under an approved
State licensure program (subpart E of part 493); (2) emphasizing
education in proficiency testing to improve laboratory performance
(subpart H of part 493); and (3) focusing on an outcome-oriented
approach in laboratory inspections (subpart Q of part 493).
A. Accreditation of a Laboratory by a Private, Nonprofit Accreditation
Organization or Exemption From CLIA Requirements Under an Approved
State Laboratory Program (Subpart E)
Based on the requirements in section 353(e) and (p) of the Public
Health Service Act and regulations in part 493, subpart E, HCFA has
approved six accreditation organizations. They are: American
Association of Blood Banks, American Osteopathic Association, American
Society for Histocompatability and Immunogenetics, College of American
Pathologists, Commission on Office Laboratory Accreditation, and Joint
Commission on Accreditation of Healthcare Organizations. We have also
approved three State licensure programs for CLIA exemption of licensed
laboratories within the State: Washington, New York, and Oregon.
The existing regulations in subpart E contain duplicative
information, which we are eliminating by restructuring subpart E and
consolidating requirements. The revised subpart better reflects the
process involved and better organizes the information required from
organizations and States to obtain HCFA approval. This restructuring
does not change the current requirements, but only redesignates them
into a more customer-oriented document, making them easier for users to
understand. In this process, we use new section numbers, but retain all
the requirements in subpart E.
B. Participation in Proficiency Testing for Laboratories Performing
Tests of Moderate Complexity (Including the Subcategory of Provider-
performed Microscopy), High Complexity, or Any Combination of These
Tests (Subpart H)
Proficiency testing (PT) is the testing of laboratory samples, the
values of which are unknown to the laboratory, to assess the accuracy
of the laboratory's results. PT serves as a test performance indicator,
as well as provides invaluable feedback. Under the CLIA regulations,
laboratories test PT samples three times a year for the tests the
laboratory performs, which are listed in subpart I of part 493. Samples
for these three testing events are provided and graded by HCFA-approved
PT programs. A laboratory's performance is described as satisfactory
performance, unsatisfactory performance, or unsuccessful performance.
Satisfactory performance occurs when a laboratory attains a passing
score for all analytes, subspecialties, or specialties. Unsatisfactory
performance occurs when a laboratory fails to attain the minimum
satisfactory score for an analyte, subspecialty, or specialty for a
testing event. Unsuccessful performance occurs when a laboratory fails
to attain the minimum satisfactory score for an analyte, subspecialty,
or specialty for two consecutive or two of three consecutive testing
events.
Comments Concerning Regulatory Use of PT
In response to the concerns of commenters received on the final
rule published February 28, 1992, we are emphasizing our existing
policy that uses PT as an outcome indicator of laboratory performance
and for educational purposes. We found that the commenters'
recommendations were consistent with our regulatory reform initiative.
Comment: Many commenters recommended that we use PT performance
more for educational purposes than for punitive actions. Commenters
stated that PT is an excellent mechanism for assisting laboratories to
identify and solve problems, evaluate personnel, and improve test
performance; however, while PT is a valuable educational tool, it has
limitations that should preclude it from use as the sole indicator for
regulatory intervention.
Response: We agree with the commenters. We allow a laboratory to
undertake education or training, or both, to correct initial
unsuccessful PT performance for each laboratory specialty in which it
performs PT. An educational focus for an initial occurrence of
unsuccessful PT affords the laboratory further opportunity to undertake
training of its personnel, or to obtain technical assistance, or both,
to identify, correct, and prevent the problems that led to PT failures.
We are revising subpart H to clarify and emphasize HCFA's educational
approach. This approach will not release the laboratory from its
responsibility to perform patient testing accurately and reliably. It
is, however,
[[Page 26724]]
less punitive than some laboratories' initial perception of the PT
actions we would impose, and provides an incentive, as well as a
mechanism for laboratories to improve their performance.
The enforcement provisions in Sec. 493.1838 give a laboratory the
opportunity to train personnel or to obtain technical assistance, or
both, when the laboratory has performed PT unsuccessfully. We are
adding a new paragraph (c) to Sec. 493.803, which sets forth the
educational emphasis of PT, to respond to comments received on PT
requirements. These regulatory additions unify commenters'
recommendations with the Administration's Reinventing Government
initiative by focusing on education as a correction to the problem, as
opposed to punitive measures.
Comment: Commenters recommended that HCFA use PT performance as an
index of performance or a screening tool to identify potential
problems. Commenters also suggested that we impose stricter sanctions
(that is, that we remove from a laboratory's certificate the
laboratory's authorization to test a specific analyte) when a
laboratory demonstrates an unwillingness or inability to correct the
problems that caused the failure.
Response: We agree with the commenters. We have also established
some exceptions at Sec. 493.803(c) that encompass the commenters'
suggestions. We would take more assertive actions when there is an
immediate jeopardy to patient health and safety, when a laboratory
demonstrates an inability or unwillingness to provide evidence that it
has taken steps to correct its PT problem(s), or if it has a history of
noncompliance with CLIA requirements other than proficiency testing
(for example, a laboratory that has had condition level deficiencies in
quality control).
C. Inspection--Subpart Q
We are revising part 493 subpart Q, Inspections, in response to
commenters' concerns. We are also reconstructing this subpart into a
more concise format, using succinct, easier to understand language.
Additionally, we are redirecting the HCFA inspection process to focus
more on outcomes, rather than a solely process-oriented review of a
laboratory. These actions also follow the Administration's Reinventing
Government initiative in that the onsite survey is less process
dependent.
1. Alternate Quality Assessment Survey
Comment: We received comments requesting that we inspect
laboratories onsite every 2 years, but provide a ``paper inspection''
that the laboratory would complete between biennial onsite inspections.
Response: We believe that it would be a prudent use of our
resources, and a sensible means of allowing greater flexibility than
the program currently provides, to have an inspection scheme that gears
itself to the variations we see in laboratory compliance. For those
laboratories that we believe pose potential risks to public health and
safety, judging from their compliance history, we continue to believe
that regular onsite inspections present the most viable course of
assuring ourselves that these laboratories maintain compliance with
CLIA requirements. On the other hand, for those laboratories that have
a sustained record of maintaining compliance, the need to have a
constantly recurring onsite presence is not as compelling.
We believe that the statute specifically authorizes our focussed
use of limited inspection resources. Specifically, section 353(g)(2) of
the Public Health Service Act calls for inspections to be performed on
a biennial basis, ``or with such other frequency as the Secretary
determines to be necessary to assure compliance'' with CLIA standards.
We believe that the use of the Alternate Quality Assurance Survey
allows us to be in a position to inspect onsite with less frequency
than we have before, while still assuring that those laboratories that
require the closest supervision will continue to receive it. This
approach would further the statutory mandate that we have a schedule
for inspections that enables us to ensure facility compliance with
program requirements.
With input from our partners in the State survey agencies and our
regional office surveyors, we will review and evaluate information,
such as the type and number of deficiencies (if any) cited at the last
onsite inspection, proficiency testing performance, and complaints
lodged against the laboratory. We consider information of this type in
determining whether a laboratory may be a candidate for this self-
inspection (the Alternate Quality Assessment Survey). We believe that a
self-inspection process will motivate laboratories to improve their
performance. It is also an example of the Reinventing Government
initiative put into practice.
A laboratory may receive the Alternate Quality Assessment Survey in
lieu of an onsite inspection. Based on a review of the completed
Alternate Quality Assessment Survey form and information submitted by
the laboratory, should we conclude that, for any reason, the laboratory
is not performing in a manner expected by the statute and regulations,
we will follow the Alternate Quality Assessment Survey with an onsite
inspection to verify that the laboratory is in compliance with CLIA
requirements. A laboratory will not receive the Alternate Quality
Assessment Survey for two consecutive certification cycles.
We will monitor and evaluate the effectiveness of the Alternate
Quality Assessment Survey process through verification inspections of
approximately 5 percent of the laboratories receiving the self-survey
questionnaire. We will adjust the self assessment process, as
indicated.
2. Outcome-oriented Survey Process
Comment: Among the commenters' recommendations were indications
that our February 28, 1992 regulations implementing the CLIA
requirements may not be applicable to all functions of all
laboratories. We were reminded that certain standards might not be
required for every type of testing performed; for example, the
requirements for specimen preparation and storage of specimens would
not directly apply to most point-of-care testing and, typically, have
minimum impact on the quality of testing in this setting. Although HCFA
surveyors have not held laboratories to requirements that are not
applicable to a particular laboratory's testing activities, there was a
concern from the commenters that the surveyors would interrupt direct
patient care and spend an inordinate amount of time performing a line-
by-line comparison of regulations that would not apply to the type of
testing performed by the entity.
Response: In an effort to be responsive to those concerns, we are
enhancing our inspection or survey process by focusing on outcomes. The
outcome-oriented survey is the onsite inspection mechanism that is used
for all laboratories. Onsite inspections are performed for: initial
surveys for newly regulated laboratories; validation inspections of
accredited or CLIA-exempt laboratories, laboratories that do not
qualify for the Alternate Quality Assessment Survey; and for alternate
cycles for those laboratories completing the Alternate Quality
Assessment Survey. The emphasis of the survey is on the quality of the
laboratory's performance and is based on a review of the laboratory's
oversight and monitoring of its preanalytical,
[[Page 26725]]
analytical, and postanalytical testing processes using the quality
assurance requirements in the regulations. Surveyors will review
laboratory performance from the perspective of the effect on patient
care rather than a line-by-line comparison for regulatory compliance.
While we will look at outcomes as indicators of compliance, should we
identify noncompliance with requirements set forth in the CLIA rules,
we will cite deficiencies and, if necessary, impose sanctions. Our
improvements to the survey mechanism are also in line with the
Administration's Reinventing Government initiative by focusing on
outcomes, as opposed to process.
In summary, on commenters' recommendations, we are providing to
laboratories an onsite survey process that is less process dependent
and more outcome-oriented, as well as a self-evaluative assessment (the
Alternate Quality Assessment Survey), to motivate laboratories toward
self-monitoring of their overall performance.
3. Specific Comments and Responses on Issues Concerning Inspection of
Laboratories
We received 114 comments concerning subpart Q, Inspections. Many of
the commenters raised identical or closely related issues, and we
combined them, when appropriate.
Comment: We received numerous comments regarding announced versus
unannounced inspections. Some commenters believed that only a physician
office laboratory should have announced inspections, especially when
direct patient care is provided. They believed that it would be a waste
of the inspector's time if, at the time of the inspection, the
laboratory was closed, the director unavailable, or the laboratory was
not conducting testing. Other commenters believed that the option for
announced inspections should be provided to all laboratories. These
commenters believed that, even if given advance notice of an
inspection, a laboratory would still not be able to ``falsify''
documentation or other data that would not be readily identified by a
competent inspector. Another group of commenters stated that follow-up
inspections should be unannounced. One commenter believed that we
should set standards limiting agency discretion to conduct unannounced
inspections. Still another commenter believed that ``warrants'' should
be required when the laboratory owner does not give advance consent for
his or her laboratory to be inspected.
Response: We agree with commenters who recommended announced
inspections for all laboratories. We have instituted a policy of
announced inspections for all initial and recertification inspections,
which allows a laboratory the latitude to include multiple members of
the staff in the inspection process for the educational value.
Announced, routine inspections are more efficient, in that the
laboratory can make previous testing records more accessible before the
inspection, and these inspections are also less intrusive when the
laboratory is a health care facility providing direct patient care.
We are revising subpart Q by eliminating the modifiers ``announced
and unannounced'' and keeping only the unqualified term
``inspections.'' This is in accordance with section 353(g)(1) of the
Public Health Service Act, which clearly provides for either announced
or unannounced inspections. This provision applies to all laboratories,
in keeping with the site-neutral intent of the CLIA statute. However,
we are maintaining our policy that all complaint and follow-up
inspections are unannounced and are conducted during routine hours of
operation. Because these inspections are most probably for cause,
laboratories are evaluated during normal operating conditions so that
an appropriate assessment can be made.
We disagree with the commenter who believed that we should develop
standards limiting agency discretion to conduct unannounced
inspections. The law allows the Secretary to determine when announced
or unannounced inspections should be conducted and does not call for
standards to be developed limiting this provision. We believe that the
survey procedures and instructions contained in the HCFA State
Operations Manual (HCFA Pub. 7) adequately outline situations in which
an announced or unannounced inspection should be conducted.
We disagree with the commenter who suggested that we require a
``warrant'' when the laboratory owner does not give advance consent for
the laboratory to be inspected. The law provides us with the authority
to enter a laboratory for the purpose of conducting an inspection. If
an owner, director, or any employee of the laboratory refuses our
reasonable request for permission to inspect the laboratory and its
operations, the laboratory may be subject to revocation of its CLIA
certificate, as provided in section 353(i)(1)(E) of the Public Health
Service Act and Sec. 493.1840 of the regulations.
Comment: A few commenters said the word ``will'' should be changed
to ``may'' in the following context: ``HHS will conduct announced or
unannounced surveys'' at Sec. 493.1776(a) (now found at
Sec. 493.1775(b)).
Response: We agree with the commenters. However, as previously
explained, we are removing the specific words ``announced'' and
``unannounced,'' and the pertinent portion of Sec. 493.1775(b) now
reads, `` * * * HCFA or a HCFA agent may conduct an inspection at any
time during the laboratory's hours of operation * * *'' to be
consistent with the rest of the subpart.
Comment: One commenter believed that CLIA requires yearly
inspections, while other commenters recommended that we conduct
inspections every other year onsite with a paper inspection in
alternate years.
Response: Section 353(g)(1) of the Public Health Service Act
requires inspections on a biennial basis or with such other frequency
that the Secretary determines necessary to ensure compliance with the
CLIA requirements. We conduct complaint inspections, as necessary,
after we determine that the complaint alleges a violation of CLIA
requirements. We agree with the commenters' recommendation for onsite
inspections to be alternated with a self-evaluative survey. We have
developed a self-assessment form, the Alternate Quality Assessment
Survey, to be used in alternate cycles for laboratories with a history
of compliance because there is less need to have a constantly recurring
presence in those laboratories.
Comment: Some commenters suggested that inspections be conducted by
professional organizations. There was concern that surveyors would not
be knowledgeable about specialty testing or regulatory requirements,
and might inappropriately apply requirements. Another group of
commenters believed that cytology inspections should be conducted by a
qualified pathologist and cytotechnologist.
Response: Inspections for laboratories holding certificates of
compliance are performed by HCFA regional office laboratory consultants
or State survey agency personnel, or both, and stress an outcome-
oriented focus. In addition to mandatory participation at a HCFA-
sponsored laboratory surveyor training program and one-on-one training
with an experienced surveyor, we also provide written guidelines to
assist surveyors in evaluating laboratory compliance with Federal
regulations. This training provides the surveyor with comprehensive,
detailed information regarding the regulations, outcome-oriented survey
process, and surveyor
[[Page 26726]]
guidelines, all of which complement their technical background.
Training is also provided at the State and Federal regional levels on
an on-going basis. Moreover, we have a contract in place with an
organization of cytology professionals, which provides specialized
reviews of selected cytology laboratories. The individuals who
participate in these reviews are qualified as general supervisors and
technical supervisors in cytology. This contract has been in effect
since 1989.
HCFA also has approved six professional organizations as
accrediting bodies under CLIA. These organizations sought deeming
authority for their programs, which were equal to, or more stringent
than, the CLIA requirements taken as a whole. A laboratory may,
therefore, choose to apply for a certificate of accreditation; in which
case, a HCFA-approved accreditation organization would serve as its
inspecting agency for CLIA.
Comment: One organization believed that it is inappropriate for a
surveyor to interview an employee during an inspection, and if a
disgruntled employee makes false or specious comments against his or
her employer, it may impugn the reputation of the laboratory director.
Response: We disagree. Any interviews conducted during the course
of an inspection are to assist the surveyor in gathering information
for the determination of the laboratory's compliance with the
applicable requirements under part 493. Any pertinent information
received during an inspection is verified, and determination of a
facility's compliance is based on all elements of the inspection
process, not just individual interviews.
Comment: Another group of commenters was concerned that patient
records will be reviewed during the course of the inspection and
believed that patient privacy may be compromised.
Response: We understand the commenters' concerns; however,
laboratory surveyors are health care professionals who are familiar
with the need for patient privacy. Confidentiality of patient and
laboratory information is also reinforced during surveyor training
sessions. Laboratory surveyors appreciate and respect patient
confidentiality. Therefore, we do not believe patient privacy would be
compromised.
Comment: A few commenters believed that we should only conduct
inspections for cause. One commenter believed that complaints should be
better defined. Another commenter believed that complaints should be
verified before a complaint inspection is conducted.
Response: Section 353(g)(2) of the Public Health Service Act
requires that we conduct inspections biennially or with such frequency
as the Secretary determines is necessary. For those laboratories with a
history of compliance, there is less need to have a constantly
recurring onsite presence, and we have developed a self-evaluative
survey, the Alternate Quality Assessment Survey, to be used in
alternate cycles. We believe the use of the Alternate Quality
Assessment Survey allows us to be in a position to inspect onsite with
less frequency than we have before, while still ensuring that those
laboratories that require the closest supervision will continue to
receive it.
A complaint is an allegation against a laboratory by any individual
for any perceived or real violation of the CLIA requirements. For
example, there may be a complaint that a laboratory is operating
without a certificate or that a laboratory is performing testing
outside of the certificate it holds. Inspectors are instructed to
determine if the complaint involves CLIA requirements or regulations
under the jurisdiction of another agency. If the complaint involves a
violation of State or other Federal law that is under the jurisdiction
of another agency (for example, the Occupational Safety and Health
Administration), we refer the complaint to the appropriate State or
agency for investigation. If the complaint is an alleged violation of
the CLIA requirements, we may conduct an unannounced onsite inspection
focusing on the alleged violations.
Comment: A commenter wanted the phrase ``including allegations that
individuals other than physicians are performing microscopic exams''
added at Sec. 493.1776(a)(2). Another group of commenters believed that
we should conduct unannounced inspections to substantiate which
individuals are performing testing.
Response: When a complaint alleges that an individual performing
tests is not qualified, we investigate the laboratory's compliance with
the CLIA personnel qualification requirements. It is our policy to
conduct unannounced complaint inspections. To clarify this policy we
are moving Sec. 493.1776(a)(2) to Sec. 493.1775(b) and also referencing
this in Sec. 493.1773(f).
Comment: Some commenters objected to ``onsite proficiency testing''
as part of the inspection process as being inappropriate based on the
complications involved in testing PT samples and suggested that we
delete Sec. 493.1777(b)(1).
Response: We disagree with the commenters. Section 493.1777(b)(1),
now Sec. 493.1773(b)(1), provides the surveyor with the authority to
require a laboratory to perform testing, which may include analysis of
PT samples from a HCFA-approved PT program, as part of the inspection.
We are aware of the complications referred to by the commenters.
Although the option of requiring a laboratory to perform testing on PT
samples exists, it is not routinely employed by surveyors. If it were
employed, it would be structured to address complications expressed by
the commenters.
Comment: One commenter believed that we should require onsite
(proficiency) testing during routine inspections for laboratories
holding a certificate of waiver.
Response: Section 353(d)(2)(C) of the Public Health Service Act
specifically exempts laboratories performing only waived tests from
routine inspections and all quality standards including PT. We,
therefore, may not require this testing or routinely inspect waived
testing.
Comment: A few commenters suggested that we add the following
language to Sec. 493.1775, ``States may coordinate the Medicare/
Medicaid compliance surveys for skilled nursing facilities, nursing
facilities, and intermediate care facilities for the mentally retarded
with CLIA compliance activities.''
Response: We encourage coordination of inspections under the
Medicare, Medicaid, and CLIA programs. Due to separate laws and
funding, resources, expertise, and availability, we can do no more than
encourage inspectors from different programs to coordinate inspections
to reduce the burden on facilities. Thus, we are making no change to
the regulations.
Comment: Commenters also suggested that we change Sec. 493.1775(d)
to read: ``* * *payments for laboratory services to the laboratory or *
* * `` to ensure that a suspension of Medicare payments for laboratory
services by a provider could not result in the suspension of payments
for any non-laboratory services.
Response: We are moving this requirement from Sec. 493.1775(d) to
Sec. 493.1773(g). As stated above, CLIA and Medicare/Medicaid are
separate programs. Actions we take under the CLIA program may result in
a laboratory being unable to perform certain tests. We notify the
Medicare and Medicaid programs, as appropriate, of any action we take
to suspend, limit or revoke the
[[Page 26727]]
CLIA certificate, which may have an impact on the facility's overall
participation in Medicare/Medicaid.
Comment: One commenter suggested that we change
Sec. 493.1780(b)(4)(ii) to ensure that inspection reports from
accreditation bodies are readily available to inspectors.
Response: The current regulations require that an accrediting
organization submit pertinent information to HCFA, which includes
inspection reports from the accreditation organization's surveys. We
find that performing validation inspections without prior knowledge of
the organization's findings offers a more unbiased approach for our
surveyors than performing inspections with prior knowledge. Therefore,
inspection reports from accreditation organizations are not normally
made available to surveyors before they perform validation inspections.
However, these reports are used in the comparability review of the
organization's inspection.
Comment: Some commenters urged us to approve the College of
American Pathologists as an accrediting organization, so that
laboratories that are accredited by this organization will meet CLIA
requirements.
Response: HCFA approved the College of American Pathologists as an
accreditation organization (see notice published February 9, 1995 in
the Federal Register at 60 FR 7774). Five other organizations have also
been approved as accreditation organizations: American Association of
Blood Banks; American Osteopathic Association; American Society for
Histocompatibility and Immunogenetics; Commission on Office Laboratory
Accreditation; and Joint Commission on Accreditation of Health Care
Organizations.
Comment: Several commenters indicated that it is possible for
mobile laboratories providing services in more than one State to
operate under one certificate. They questioned which State would have
the responsibility to inspect the laboratories.
Response: When a mobile laboratory provides service in more than
one State under one certificate, the State in which the laboratory's
home base is located has the responsibility to ascertain compliance
with the regulations. This may involve contacting other State survey
agencies and coordinating survey activity or scheduling the survey to
coincide with testing performed in the State in which the home base is
located.
Comment: Another commenter suggested that we inspect a mobile
laboratory when it reaches a specific mileage limit.
Response: Section 353(g)(2) of the Public Health Service Act
requires that we conduct inspections on a biennial basis or with such
other frequency as the Secretary determines to be necessary to assure
compliance with CLIA requirements and standards. While there is
latitude in determining frequency of inspection, we believe the
assurance of accurate testing is independent of mileage traveled.
Therefore, we will continue to inspect mobile laboratories with the
same frequency as other types of laboratories.
Conforming Changes
To avoid the continued use of an overly long term in the text of
the regulations, we are adding a definition for the term, ``State
licensure program,'' which means a State laboratory licensure or
approval program.
III. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite prior public comment on proposed rules. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and
substances of the proposed rule or a description of the subjects and
issues involved. This procedure can be waived, however, if an agency
finds good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued.
With regard to all elements of this regulation except one, we are
responding to comments we received in previous rulemaking documents
and, in response to earlier rules. Accordingly, a final rule is
justified. The one exception concerns the rewritten subpart E. But
here, since we are making no substantive changes, but merely condensing
and reorganizing content, we believe that it is unnecessary and not in
the public interest to delay the effectiveness of this clarification,
as would happen were we to issue a proposed rule.
Therefore, we find good cause to waive the notice of proposed
rulemaking and to issue this final rule.
IV. Redesignation Table
The following table is a guide to readers in identifying the source
of requirements in the final rule.
------------------------------------------------------------------------
Existing section New section
------------------------------------------------------------------------
493.501(a) introductory text........... 493.551(a)
493.501(a)(1).......................... 493.551(a)(1)
493.501(a)(2).......................... 493.551(a)(2)
493.501(b) introductory text........... 493.551(b)
493.501(b)(1).......................... 493.551(a)(3)
493.501(b)(2).......................... 493.551(a)(3)
493.501(b)(3).......................... 493.551(b)(1)
493.501(b)(4).......................... 493.551(b)(2)
493.501(c) introductory text........... 493.553(a)
493.501(c)(1).......................... 493.557(a)(1)
493.501(c)(2).......................... 493.553(a)(1)
493.501(c)(3).......................... 493.553(a)(2) (i)-(iv) & (vi)
493.501(c)(4).......................... 493.553(a)(3)
493.501(c)(5).......................... 493.557(a)(2)
493.501(c)(6).......................... 493.557(a)(3) (i)-(iii)
493.501(c)(7).......................... 493.553(a)(4)
493.501(c)(8).......................... 493.553(a)(5)
493.501(c)(9).......................... 493.553(a)(6)
493.501(c)(10)......................... 493.557(a)(4)
493.501(c)(11)......................... 493.557(a)(5)
493.501(c)(12)......................... 493.553(a)(2)(v)
493.501(d) introductory text........... 493.553(b)
493.501(d)(1).......................... 493.553(b)(1)
493.501(d)(2).......................... 493.553(b)(2)
[[Page 26728]]
493.501(d)(3).......................... 493.553(b)(3)
493.501(d)(4).......................... 493.553(c)
493.501(d)(5).......................... 493.553(d)
493.501(d)(6).......................... 493.561(a)(1)
493.501(d)(7).......................... 493.561(b) (1)-(3)
493.501(d)(8).......................... 493.561(a)(2)
493.501(e) introductory text........... 493.559(a)
493.501(e)(1).......................... 493.559(b)(1)
493.501(e)(2).......................... 493.559(b)(4)
493.501(e)(3).......................... 493.559(b)(2)(ii)
493.501(e)(4).......................... 493.559(b)(5)
493.503(a)............................. 493.551(b)(3)
493.503(b)(1).......................... 493.551(b)(4)
493.503(b)(2).......................... 493.551(b)(4)
493.503(b)(3).......................... 493.551(b)(5)-(6)
493.503(b)(4).......................... 493.551(b)(6)
493.504................................ 493.551(c)
493.506(a)............................. 493.559(b)(2)(i) &
493.557(a)(1)
493.506(b)(1).......................... 493.555(a)
493.506(b)(2)(i)....................... 493.557(a)(3) (i)-(iii)
493.506(b)(2)(ii)...................... 493.555(b)
493.506(b)(2)(iii)..................... 493.557(a)(6)
493.506(b)(2)(iv)...................... 493.557(a)(7)
493.506(b)(2)(v)....................... 493.557(a)(8)
493.506(b)(2)(vi)...................... 493.557(a)(9)
493.506(b)(2)(vii)..................... 493.557(a)(10)
493.506(b)(2)(viii).................... 493.557(a)(11)
493.506(b)(3)(i)....................... 493.555(c)(1)
493.506(b)(3)(ii)...................... 493.555(c)(2)
493.506(b)(3)(iii)..................... 493.555(c)(3)(i)
493.506(b)(3)(iv)...................... 493.555(c)(4)
493.506(b)(3)(v)....................... 493.555(c)(5)
493.506(b)(3)(vi)...................... 493.557(b)(12)(i)-(ii)
493.506(b)(3)(vii)..................... 493.557(b)(13)
493.506(b)(3)(viii).................... 493.557(b)(14)
493.507(a) introductory text........... 493.563(a)(1)
493.507(a)(1).......................... 493.563(b)
493.507(a)(2).......................... 493.563(c)
493.507(b)............................. 493.565
493.507(c)............................. 493.567
493.507(d)............................. 493.569
493.507(e)............................. 493.571
493.507(f)............................. 493.563(e) + (d)
493.509(a)............................. 493.573(a)
493.509(b)............................. 493.573(b)
493.509(c)............................. 493.573(c)
493.509(d)............................. 493.573(d)
493.511(a)(1).......................... 493.575(a)(1)
493.511(a)(2).......................... 493.575(a)(3)
493.511(a)(3).......................... 493.575(a)(4) & (a)(4)(i)
493.511(b)............................. 493.575(b)(1)
493.511(c)............................. 493.575(b)(2)
493.511(d) introductory text........... 493.575(c)
493.511(d)(1).......................... 493.575(c)(1)
493.511(d)(2).......................... 493.575(c)(2)
493.511(d)(3)-(4)...................... 493.575(c)(3)
493.511(d)(5).......................... 493.575(c)(4)
493.511(e)............................. 493.575(d)
493.511(f)............................. 493.575(e)
493.511(g)............................. 493.575(f)
493.511(h)............................. 493.575(g)(1) & (g)(3)
493.511(i)............................. 493.575(h)(1)
493.511(j)............................. 493.575(k)
493.513(a) introductory text........... 493.553(c) & 493.551(a)
493.513(a)(1)-(2)...................... 493.551(a)(1)
493.513(a)(3).......................... 493.551(a)(2)
493.513(a)(4).......................... 493.557(b)(1)
493.513(a)(5).......................... 493.557(b)(2)
493.513(a)(6).......................... 493.557(b)(3)
493.513(a)(7).......................... 493.557(b)(4)
493.513(a)(8).......................... 493.557(b)(5)
493.513(b)(1)-(2)...................... 493.551(a)(3)
493.513(c) introductory text........... 493.553(a)
493.513(c)(1).......................... 493.553(a)(1)
[[Page 26729]]
493.513(c)(2).......................... 493.553(a)(2)(i)-(vi)
493.513(c)(3).......................... 493.557(b)(1)
493.513(c)(4).......................... 493.553(a)(3)
493.513(c)(5).......................... 493.553(a)(4)
493.513(c)(6).......................... 493.553(a)(5)
493.513(c)(7).......................... 493.553(a)(6)
493.513(c)(8).......................... 493.553(b)(6)
493.513(d)(1).......................... 493.557(b)(7)
493.513(d)(2).......................... 493.557(b)(8)(i)-(iii)
493.513(e)............................. 493.553(b)(1)
493.513(f)............................. 493.553(b)(2)
493.513(g)............................. 493.553(b)(3)
493.513(h)............................. 493.561(c)
493.513(i)............................. 493.553(d)
493.513(j)............................. 493.561(a)(1)
493.513(k)............................. 493.559(a)
493.513(k)(1).......................... 493.559(b)(1)
493.513(k)(2).......................... 493.559(b)(4)
493.513(k)(3).......................... 493.559(b)(3)
493.513(k)(4).......................... 493.559(b)(5)
493.513(l)............................. 493.557(b)(14)
493.513(m)............................. 493.561(a)(2)
493.515 (a)(1)......................... 493.555(a)
493.515(a)............................. 493.555 introductory text
493.515(a)(2).......................... 493.555(b)
493.515(a)(2)(ii)...................... 493.557(b)(9)
493.515(a)(2)(iii)..................... 493.557(b)(10)
493.515(a)(3) introductory text........ 493.555(c) introductory text
493.515(a)(3)(i)....................... 493.555(c)(1)
493.515(a)(3)(ii)...................... 493.555(c)(2)
493.515(a)(3)(iii)..................... 493.555(c)(4)
493.515(a)(3)(iv)...................... 493.557(b)(11)
493.515(a)(3)(v)....................... 493.557(b)(12)
493.515(a)(3)(vi)...................... 493.557(b)(13)
493.515(a)(3)(vii)..................... 493.555(c)(3)(ii)
493.515(a)(3)(viii).................... 493.555(c)(5)
493.517(a)............................. 493.563(a)(2)(i)-(ii)
493.517(a)(1).......................... 493.563(b)(1)(2)
493.517(a)(2).......................... 493.563(c)(1)-(2)
493.517(b)(1).......................... 493.565(a)
493.517(b)(2).......................... 493.565(b)
493.517(b)(3).......................... 493.565(c)
493.517(c)............................. 493.567(b)
493.517(d)............................. 493.569(b)
493.517(e)............................. 493.571(b) and (c)
493.517(f)............................. 493.563(f)
493.519(a)............................. 493.573(a)
493.519(b)............................. 493.573(b)
493.519(c)(1).......................... 493.573(c)(1)
493.519(c)(2).......................... 493.573(c)(2)
493.519(d) introductory text........... 493.573(d)(1)(ii)
493.519(d)(1)-(4)...................... 493.573(d)(2)(i)-(iv)
493.521(a)(1).......................... 493.575(a)(2)
493.521(a)(2).......................... 493.575(a)(3)
493.521(a)(3).......................... 493.575(a)(4) & (4)(ii)
493.521(b)............................. 493.575(b)(1)
493.521(c)............................. 493.575(b)(2)
493.521(d)............................. 493.575(c)
493.521(e)............................. 493.575(d)
493.521(f)............................. 493.575(e)
493.521(g)............................. 493.575(i)
493.521(h)............................. 493.575(h)
493.521(i)............................. 493.575(f)
493.521(j)............................. 493.575(g)(2)-(3)
493.521(k)............................. 493.575(j)(1)-(2)
493.521(l)............................. 493.575(k)
493.1775(a)............................ 493.1773(a); 493.1775(a)
493.1775(b)(1)......................... 493.1773(b)(2)
493.1775(b)(2)......................... 493.1773(b)(4)
493.1775(b)(3)......................... 493.1773(b)(3)
493.1775(b)(4)(1)-(ii)................. 493.1773(f); 493.1775(b)(1)-(4)
493.1775(b)(4)(iii)-(iv)............... 493.1775(a)
493.1775(b)(5)......................... 493.1773(b)(5)
493.1775(c)............................ 493.1773(d)
[[Page 26730]]
493.1775(d)............................ 493.1773(g)
493.1776(a) introductory text.......... 493.1773(a); 493.1775(a) & (b)
493.1776(a)(1)-(4)..................... 493.1773(f); 493.1775(a)
493.1776(a)(4) (uncoded text).......... deleted; redundant
493.1776(b)(1)......................... 493.1773(b)(2)
493.1776(b)(2)......................... 493.1773(b)(4)
493.1776(b)(3)......................... 493.1773(b)(3)
493.1776(b)(4)......................... 493.1773(f); 493.1775(b)(1)-(4)
493.1776(b)(5)......................... 493.1773(b)(5)
493.1776(c)............................ 493.1773(d)
493.1776(d)............................ 493.1773(g)
493.1777 introductory text............. 493.1773(a), (f); 493.1777(a)-
(c)
493.1777(a)............................ 493.1777(a)-(b)
493.1777(b)............................ 493.1773(b)
493.1777(c)............................ 493.1773(c)
493.1777(d)............................ deleted; redundant
493.1777(e)............................ 493.1773(d)
493.1777(f)............................ 493.1773(e)
493.1777(g)............................ 493.1773(g)
493.1780(a)............................ 493.1773(a); 493.1780(a)
493.1780(b)............................ 493.1773(a), (f); 493.1780(b)
493.1780(c)............................ 493.1773(b)
493.1780(d)............................ 493.1773(c)
493.1780(e)............................ deleted; redundant
493.1780(f)............................ 493.1773(d)
493.1780(g)............................ 493.1773(g); 493.1780(c)
------------------------------------------------------------------------
V. Regulatory Impact Statement
A. General
Consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612), we prepare a regulatory flexibility analysis unless we
certify that a rule will not have a significant economic impact on a
substantial number of small entities. For purposes of the RFA, all
clinical laboratories are considered to be small entities. Individuals
and States are not included in the definition of a small entity.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. Such
an analysis must conform to the provisions of section 604 of the RFA.
For purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 50 beds.
B. Provisions of the Final Regulations
This rule has been drafted in response to comments pertaining to
proficiency testing and the CLIA inspection process. As our responses
to commenters' concerns were developed, it became apparent that we were
also fulfilling the Administration's regulatory reform initiative. This
initiative directs us to revise regulations that are outdated or
otherwise in need of reform. We have, therefore, also included subpart
E of part 493 in this rule.
Subpart E
Subpart E of part 493 provides for the accreditation of a
laboratory by an accreditation organization, and the exemption of
laboratories within a particular State from CLIA requirements when the
accreditation organization or State applies requirements that are equal
to, or more stringent than, the CLIA requirements taken as a whole.
Subpart E contains requirements for State licensure programs,
accreditation organizations, laboratories seeking deemed status by
virtue of accreditation by a HCFA-approved accreditation organization,
and laboratories that operate within a State that HCFA has determined
maintains requirements that are equal to or more stringent than the
CLIA requirements. We are revising subpart E by removing duplicative
information. We are reorganizing subpart E to distinguish accreditation
organization and State licensure program responsibilities from those of
laboratories. We are combining common requirements for accreditation
organizations and State licensure programs. These actions will
accommodate the Administration's regulatory reform initiative. We are
making no substantive changes to the content or the intent. Therefore,
we are not imposing additional burden. The relief established by
reorganizing and combining like requirements is not quantifiable, but
it should aid in the submission of materials for approvals and
reapprovals.
Subpart H
The changes we are making in Sec. 493.803(c) reflect HCFA's policy
of an educational focus for proficiency testing. We are clarifying
existing enforcement options in response to comments received
concerning PT sanctions. In this rule, subpart H provides that, if a
laboratory is initially unsuccessful in PT, it must obtain technical
assistance, or undertake training of personnel, or both, rather than
having HCFA impose principal or alternative sanctions. This affords the
laboratory an additional opportunity to correct the problem that caused
the PT failure, encouraging quality testing in a more positive manner.
We believe that a laboratory should have ample opportunity to
investigate the reason for its initial failure, to obtain the necessary
technical assistance or training, or both, to correct the problems that
caused the failure and implement a plan of action, which should prevent
reoccurrence. This requirement also exists in subpart R, Enforcement
Procedures. Principal and alternative sanctions may apply if the
laboratory refuses to correct its problems, has repeated compliance
problems, or immediate jeopardy exists. While this educational approach
has always been a viable option, based on comments received on previous
rulemaking, we believe that it is important to clarify that this option
exists and will be exercised. We are revising the regulation
accordingly.
We are not imposing any additional burden with this clarification;
we are
[[Page 26731]]
only identifying which of our enforcement actions or options we
implement in a particular circumstance.
Subpart Q
We are eliminating redundant information by restructuring and
organizing all generic requirements for an onsite inspection into one
section of the regulations. In addition we have implemented the
commenter-recommended laboratory self-inspection process (the Alternate
Quality Assessment Survey). Although an onsite inspection may not be
performed, the survey agency personnel must still review and evaluate
the self-inspection responses submitted by the laboratory and take any
necessary action. While travel and onsite time is eliminated for
inspections of these laboratories, the laboratory surveyors, however,
may realize little or no reduction in the time spent on the overall
process. We expect laboratories that perform the Alternate Quality
Assessment Survey to benefit from the educational aspects realized by
performing this self evaluative survey and minimized disruption to
their activities.
Our onsite survey process, which is outcome-oriented, concentrates
on a review of each laboratory's specific testing activities and its
impact on patient health and safety. We are unable to predict the long
term effects because they are dependent upon each individual
laboratory's compliance and testing activities. Although it is
difficult to quantify the financial impact due to the variability from
laboratory to laboratory, we expect that our collective efforts to
streamline and clarify the regulations may reduce the laboratory costs
associated with CLIA in many cases, without diminishing quality.
C. Conclusion
For these reasons, we have determined, and the Secretary certifies,
that this regulation does not result in a significant impact on a
substantial number of small entities and does not have a significant
effect on the operations of a substantial number of small rural
hospitals. Therefore, we are not preparing analyses for either the RFA
or section 1102(b) of the Act.
D. OMB Review
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
E. Collection of Information Requirements
This final rule contains information collections that are subject
to review by the Office of Management and Budget under the Paperwork
Reduction Act of 1995. The title, description, and respondent
description of the information collection requirements are shown below
with an estimate of the annual reporting and recordkeeping burden.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
Section 493.803 and subpart Q (newly revised Secs. 493.1771 through
493.1780 previously numbered Secs. 493.1775 through 493.1780) are
currently approved under OMB approval number 0938-0612 with an
expiration date of April 30, 2001. Subpart E (newly revised sections
Secs. 493.551, 493.553, 493.555, 493.557, 493.559, and 493.561, which
were previously contained in Secs. 493.501, 493.506, 493.513 and
493.515) is currently approved under OMB approval number 0938-0686 with
an expiration of April 30, 1999.
Section 493.803 contains the requirement that a laboratory must
successfully participate in a PT program approved by HCFA for the
specialties, subspecialties, and analytes listed in the regulation, if
these tests are performed by the laboratory. The burden associated with
this requirement is the testing of PT specimens and recording the
results.
Subpart Q sets forth conditions and standards for inspection of
laboratories. The burden associated with inspections of laboratories,
or alternative mechanisms to determine compliance, consists of
retrieving records and documentation necessary for the inspector to
ascertain compliance, participating in entrance and exit conferences
for onsite inspections, responding to a statement of deficiencies that
may result from an inspection, and documenting any corrective action.
Subpart E sets forth the requirements and process for a private,
nonprofit accreditation organization voluntarily seeking approval under
the CLIA program and a State licensure program voluntarily seeking
exemption for its laboratories within the State from the CLIA program.
The burden associated with these sections is the compilation of
specific information that must be submitted for evaluation as well as
the requirements for providing ongoing information.
Description of Respondents
Respondents for Sec. 493.803 and subpart Q, Secs. 493.1771 through
493.1780 fall in the categories of: small businesses or organizations,
businesses or other for-profit, non-profit institutions, State and
local governments, and Federal agencies.
Respondents for subpart E, Secs. 493.551, 493.553, 493.555,
493.557, 493.559, and 493.561 are private nonprofit accreditation
organizations and State licensure programs.
Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Average burden
CFR section Annual number Annual frequency per response Annual burden
of respondents in hours in hours
----------------------------------------------------------------------------------------------------------------
Subpart E 493.551 through 493.561..... 11 varies, as needed....... 192 2112
Subpart H 493.803..................... 63,600 3 events................ 1 190,800
Subpart Q 493.1771 through 493.1780... 36,918 biennial................ 4 4,618
----------------------------------------------------------------------------------------------------------------
Persons interested in commenting on these currently approved
information collections should send comments to the following address:
Health Care Financing Administration, Office of Information Services,
Information Technology Investment Management Group, Room C2-26-17, 7500
Security Boulevard, Baltimore, Maryland, 21244-1850. Attn: HCFA-2239-F.
List of Subjects in 42 CFR Part 493
Grant programs-health, Health facilities, Laboratories, Medicaid,
Medicare, Reporting and recordkeeping requirements.
42 CFR chapter IV is amended as follows:
[[Page 26732]]
PART 493--LABORATORY REQUIREMENTS
1. The authority citation for part 493 is revised to read as
follows:
Authority: Sec. 353 of the Public Health Service Act, secs.
1102, 1861(e), the sentence following sections 1861(s)(11) through
1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302,
1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16)).
Subpart A--General Provisions
Sec. 493.2 [Amended]
2. Section 493.2 is amended by adding in alphabetical order the
following definition of State licensure program:
* * * * *
State licensure program means a State laboratory licensure or
approval program.
* * * * *
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory
Program
Secs. 493.501 through 493.521 [Removed]
3. Sections 493.501 through 493.521 are removed.
4. In subpart E, new Secs. 493.551, 493.553, 493.555, 493.557,
493.559, 493.561, 493.563, 493.565, 493.567, 493.569, 493.571, 493.573,
and 493.575 are added to read as follows:
Sec.
493.551 General requirements for laboratories.
493.553 Approved process (application and reapplication) for
accreditation organizations and State licensure programs.
493.555 Federal review of laboratory requirements.
493.557 Additional submission requirements.
493.559 Publication of approval of deeming authority or CLIA
exemption.
493.561 Denial of application or reapplication.
493.563 Validation inspections--Basis and focus.
493.565 Selection for validation inspection--laboratory
responsibilities.
493.567 Refusal to cooperate with validation inspection.
493.569 Consequences of a finding of noncompliance as a result of a
validation inspection.
493.571 Disclosure of accreditation, State and HCFA validation
inspection results.
493.573 Continuing Federal oversight of private nonprofit
accreditation organizations and approved State licensure programs.
493.575 Removal of deeming authority or CLIA exemption and final
determination review.
Sec. 493.551 General requirements for laboratories.
(a) Applicability. HCFA 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 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 HCFA.
(3) The laboratory authorizes the approved accreditation
organization or State licensure program to release to HCFA 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 HCFA,
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 HCFA or
a HCFA 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 HCFA 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, HCFA 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 HCFA, 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 HCFA for deeming authority, or a State
licensure program that applies or reapplies to HCFA 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 HCFA-approved PT program.
(4) Procedures for responding to and for the investigation of
complaints against its laboratories.
[[Page 26733]]
(5) A list of all its current laboratories and the expiration date
of their 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) HCFA action on an application or reapplication. If HCFA
receives an application or reapplication from an accreditation
organization, or State licensure program, HCFA takes the following
actions:
(1) HCFA 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) HCFA 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) HCFA notifies the accreditation organization or State licensure
program indicating whether HCFA approves or denies the request for
deeming authority or exemption, respectively, and the rationale for any
denial.
(c) Duration of approval. HCFA 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.
HCFA'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 HCFA, 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 HCFA that requires
it to do the following:
(1) Notify HCFA 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 HCFA 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 HCFA, 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
HCFA's withdrawal of the organization's deeming authority or State's
exemption.
(5) Provide HCFA 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 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 HCFA 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, HCFA or
a HCFA agent monitors corrections, as authorized at Sec. 493.565(d)).
(7) A demonstration of its ability to provide HCFA 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 HCFA 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 HCFA 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 HCFA, which
includes, but is not limited to, the following:
(i) PT results that constitute unsuccessful participation in a
HCFA-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 HCFA 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:
[[Page 26734]]
(1) Demonstrate to HCFA that it has enforcement authority and
administrative structures and resources adequate to enforce its
laboratory requirements.
(2) Permit HCFA or a HCFA agent to inspect laboratories in the
State.
(3) Require laboratories in the State to submit to inspections by
HCFA or a HCFA 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 HCFA 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 HCFA 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
HCFA 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 HCFA 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 HCFA determines are necessary for validation
and assessment of the State's inspection process requirements.
(11) Agree to provide HCFA 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 HCFA not to be in compliance with requirements
comparable to condition-level requirements and report these enforcement
actions to HCFA.
(14) If approved, reapply to HCFA every 2 years to renew its exempt
status and to renew its agreement to pay the cost of the HCFA-
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. HCFA 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 HCFA 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 HCFA denies a request for
approval, an accreditation organization or State licensure program may
request, within 60 days of the notification of denial, that HCFA
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 HCFA's determination to deny its request
for approval or reapproval, it may not submit a new application until
HCFA 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.
(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) HCFA or a HCFA 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) HCFA 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) HCFA or a HCFA 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 HCFA or a HCFA 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 HCFA or a HCFA agent conducts a
validation inspection in response to a substantial allegation of
noncompliance, the inspection focuses on any condition-level
requirement that HCFA determines to be related to the allegation.
[[Page 26735]]
(2) If HCFA or a HCFA agent substantiates a deficiency and
determines that the laboratory is out of compliance with any condition-
level requirement, HCFA or a HCFA agent conducts a full CLIA
inspection.
(d) Inspection of operations and offices. As part of the validation
review process, HCFA 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 HCFA or a HCFA 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 HCFA or a HCFA agent, on a
confidential basis, a copy of the laboratory's most recent full, and
any subsequent partial inspection.
(b) Authorize HCFA or a HCFA agent to conduct a validation
inspection.
(c) Provide HCFA or a HCFA agent with access to all facilities,
equipment, materials, records, and information that HCFA or a HCFA
agent determines have a bearing on whether the laboratory is being
operated in accordance with the requirements of this part, and permit
HCFA or a HCFA agent to copy material or require the laboratory to
submit material.
(d) If the laboratory possesses a valid certificate of
accreditation, authorize HCFA or a HCFA 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 HCFA or a HCFA 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) HCFA 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, HCFA 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 HCFA, 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, HCFA directs the State to take
appropriate enforcement action.
Sec. 493.571 Disclosure of accreditation, State and HCFA validation
inspection results.
(a) Accreditation organization inspection results. HCFA 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) HCFA validation inspection results. HCFA may disclose the
results of all validation inspections conducted by HCFA 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, HCFA reviews the
equivalency of requirements in the following cases:
(1) When HCFA promulgates new condition-level requirements.
(2) When HCFA 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 HCFA determines an earlier review
is required.
(b) Validation review. Following the end of a validation review
period, HCFA 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 HCFA, 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. HCFA
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
[[Page 26736]]
validation review, must furnish HCFA, upon request, with the
reapplication materials HCFA requests. HCFA establishes a deadline by
which the materials must be submitted.
(d) Notice. (1) HCFA 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 HCFA 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 HCFA's review process on which the final
determination is based and a description of the possible actions, as
specified in Sec. 493.575, that HCFA 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) HCFA review. HCFA 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. HCFA 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. HCFA 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 HCFA'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 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 HCFA or a HCFA agent for the
following periods:
(i) One year for accreditation organizations.
(ii) Two years for State licensure programs.
(b) HCFA action after review. Following the review, HCFA may take
the following action:
(1) If HCFA determines that the accreditation organization or State
has failed to adopt requirements equal to, or more stringent than, CLIA
requirements, HCFA may give a conditional approval for a probationary
period of its deeming authority to an organization 30 days following
the date of HCFA's determination, or exempt status to a State within 30
days of HCFA'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 HCFA determines that there are widespread or systematic
problems in the organization's or State's inspection process, HCFA 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. HCFA 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. HCFA 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 HCFA 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 HCFA does not affect or limit the conduct
of any validation inspection.
(f) Federal Register notice. HCFA 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 HCFA 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 HCFA 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
HCFA's approval of the program.
(3) Extension. After HCFA withdraws approval of an accreditation
organization or State licensure program, HCFA 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 HCFA or a HCFA agent before the initial 60-day period
ends.
(h) Immediate jeopardy to patients. (1) If at any time HCFA
determines that the continued approval of deeming authority of any
accreditation organization poses immediate jeopardy to the patients of
the laboratories accredited by the organization, or continued approval
otherwise constitutes a significant hazard to the public health, HCFA
may immediately withdraw the approval of deeming authority for that
accreditation organization.
[[Page 26737]]
(2) If at any time HCFA 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, HCFA may immediately
withdraw the approval of that State licensure program.
(i) Failure to pay fees. HCFA 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) HCFA may withdraw
approval of a State licensure program if the State refuses to take
enforcement action against a laboratory in that State when HCFA
determines it to be necessary.
(2) A laboratory that is in a State in which HCFA 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 HCFA reconsider the
determination, in accordance with subpart D of part 488.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate Complexity (Including the
Subcategory), High Complexity, or Any Combination of These Tests
5. In Sec. 493.803, paragraph (b) is revised and a new paragraph
(c) is added to read as follows:
Sec. 493.803 Condition: Successful participation.
* * * * *
(b) Except as specified in paragraph (c) of this section, if a
laboratory fails to participate successfully in proficiency testing for
a given specialty, subspecialty, analyte or test, as defined in this
section, or fails to take remedial action when an individual fails
gynecologic cytology, HCFA imposes sanctions, as specified in subpart R
of this part.
(c) If a laboratory fails to perform successfully in a HCFA-
approved proficiency testing program, for the initial unsuccessful
performance, HCFA may direct the laboratory to undertake training of
its personnel or to obtain technical assistance, or both, rather than
imposing alternative or principle sanctions except when one or more of
the following conditions exists:
(1) There is immediate jeopardy to patient health and safety.
(2) The laboratory fails to provide HCFA or a HCFA agent with
satisfactory evidence that it has taken steps to correct the problem
identified by the unsuccessful proficiency testing performance.
(3) The laboratory has a poor compliance history.
Subpart Q--Inspection
6. In subpart Q, new Secs. 493.1771 and 493.1773 are added to read
as follows:
Sec. 493.1771 Condition: Inspection requirements applicable to all
CLIA-certified and CLIA-exempt laboratories.
(a) Each laboratory issued a CLIA certificate must meet the
requirements in Sec. 493.1773 and the specific requirements for its
certificate type, as specified in Secs. 493.1775 through 493.1780.
(b) All CLIA-exempt laboratories must comply with the inspection
requirements in Secs. 493.1773 and 493.1780, when applicable.
Sec. 493.1773 Standard: Basic inspection requirements for all
laboratories issued a CLIA certificate and CLIA-exempt laboratories.
(a) A laboratory issued a certificate must permit HCFA or a HCFA
agent to conduct an inspection to assess the laboratory's compliance
with the requirements of this part. A CLIA-exempt laboratory and a
laboratory that requests, or is issued a certificate of accreditation,
must permit HCFA or a HCFA agent to conduct validation and complaint
inspections.
(b) General requirements: As part of the inspection process, HCFA
or a HCFA agent may require the laboratory to do the following:
(1) Test samples, including proficiency testing samples, or perform
procedures.
(2) Permit interviews of all personnel concerning the laboratory's
compliance with the applicable requirements of this part.
(3) Permit laboratory personnel to be observed performing all
phases of the total testing process (preanalytic, analytic, and
postanalytic).
(4) Permit HCFA or a HCFA agent access to all areas encompassed
under the certificate including, but not limited to, the following:
(i) Specimen procurement and processing areas.
(ii) Storage facilities for specimens, reagents, supplies, records,
and reports.
(iii) Testing and reporting areas.
(5) Provide HCFA or a HCFA agent with copies or exact duplicates of
all records and data it requires.
(c) Accessible records and data: A laboratory must have all records
and data accessible and retrievable within a reasonable time frame
during the course of the inspection.
(d) Requirement to provide information and data: A laboratory must
provide, upon request, all information and data needed by HCFA or a
HCFA agent to make a determination of the laboratory's compliance with
the applicable requirements of this part.
(e) Reinspection: HCFA or a HCFA agent may reinspect a laboratory
at any time to evaluate the ability of the laboratory to provide
accurate and reliable test results.
(f) Complaint inspection: HCFA or a HCFA agent may conduct an
inspection when there are complaints alleging noncompliance with any of
the requirements of this part.
(g) Failure to permit an inspection or reinspection: Failure to
permit HCFA or a HCFA agent to conduct an inspection or reinspection
results in the suspension or cancellation of the laboratory's
participation in Medicare and Medicaid for payment, and suspension or
limitation of, or action to revoke the laboratory's CLIA certificate,
in accordance with subpart R of this part.
7. Section 493.1775 is revised to read as follows:
Sec. 493.1775 Standard: Inspection of laboratories issued a
certificate of waiver or a certificate for provider-performed
microscopy procedures.
(a) A laboratory that has been issued a certificate of waiver or a
certificate for provider-performed microscopy procedures is not subject
to biennial inspections.
(b) If necessary, HCFA or a HCFA agent may conduct an inspection of
a laboratory issued a certificate of waiver or a certificate for
provider-performed microscopy procedures at any time during the
laboratory's hours of operation to do the following:
(1) Determine if the laboratory is operated and testing is
performed in a manner that does not constitute an imminent and serious
risk to public health.
(2) Evaluate a complaint from the public.
(3) Determine whether the laboratory is performing tests beyond the
scope of the certificate held by the laboratory.
(4) Collect information regarding the appropriateness of tests
specified as waived tests or provider-performed microscopy procedures.
[[Page 26738]]
(c) The laboratory must comply with the basic inspection
requirements of Sec. 493.1773.
Sec. 493.1776 [Removed]
8. Section 493.1776 is removed.
9. Section 493.1777 is revised to read as follows:
Sec. 493.1777 Standard: Inspection of laboratories that have requested
or have been issued a certificate of compliance.
(a) Initial inspection. (1) A laboratory issued a registration
certificate must permit an initial inspection to assess the
laboratory's compliance with the requirements of this part before HCFA
issues a certificate of compliance.
(2) The inspection may occur at any time during the laboratory's
hours of operation.
(b) Subsequent inspections. (1) HCFA or a HCFA agent may conduct
subsequent inspections on a biennial basis or with such other frequency
as HCFA determines to be necessary to ensure compliance with the
requirements of this part.
(2) HCFA bases the nature of subsequent inspections on the
laboratory's compliance history.
(c) Provider-performed microscopy procedures. The inspection sample
for review may include testing in the subcategory of provider-performed
microscopy procedures.
(d) Compliance with basic inspection requirements. The laboratory
must comply with the basic inspection requirements of Sec. 493.1773.
10. Section 493.1780 is revised to read as follows:
Sec. 493.1780 Standard: Inspection of CLIA-exempt laboratories or
laboratories requesting or issued a certificate of accreditation.
(a) Validation inspection. HCFA or a HCFA agent may conduct a
validation inspection of any accredited or CLIA-exempt laboratory at
any time during its hours of operation.
(b) Complaint inspection. HCFA or a HCFA agent may conduct a
complaint inspection of a CLIA-exempt laboratory or a laboratory
requesting or issued a certificate of accreditation at any time during
its hours of operation upon receiving a complaint applicable to the
requirements of this part.
(c) Noncompliance determination. If a validation or complaint
inspection results in a finding that the laboratory is not in
compliance with one or more condition-level requirements, the following
actions occur:
(1) A laboratory issued a certificate of accreditation is subject
to a full review by HCFA, in accordance with subpart E of this part and
Sec. 488.11 of this chapter.
(2) A CLIA-exempt laboratory is subject to appropriate enforcement
actions under the approved State licensure program.
(d) Compliance with basic inspection requirements. CLIA-exempt
laboratories and laboratories requesting or issued a certificate of
accreditation must comply with the basic inspection requirements in
Sec. 493.1773.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program, Catalog of Federal Domestic Assistance Program
No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: October 13, 1997.
Nancy-Ann Min DeParle,
Deputy Administrator, Health Care Financing Administration.
Dated: September 18, 1997.
David Satcher,
Director, Centers for Disease Control and Prevention.
Approved: February 2, 1998.
Donna E. Shalala,
Secretary.
[FR Doc. 98-12752 Filed 5-13-98; 8:45 am]
BILLING CODE 4120-01-P
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