Request for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 1004-1009 [2017-27887]
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Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Proposed Rules
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[FR Doc. 2018–00038 Filed 1–8–18; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 493
[CMS–3326–NC]
RIN 0938–ZB40
Request for Information: Revisions to
Personnel Regulations, Proficiency
Testing Referral, Histocompatibility
Regulations and Fee Regulations
Under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA)
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Request for information.
AGENCY:
This request for information
seeks public comment regarding several
items related to Clinical Laboratory
Improvement Amendments of 1988
(CLIA) personnel requirements and
histocompatibility requirements, which,
with minor exception, have not been
updated since 1992. We are also seeking
public comment regarding the flexibility
to impose alternative sanctions for
laboratories issued a Certificate of
Waiver (CoW) determined to have
participated in proficiency testing (PT)
referral. In addition, we are seeking
public comment related to appropriate
sanctions in situations where we
determine that a laboratory has referred
its PT samples to another laboratory and
has reported the other laboratory’s result
as their own.
This request for information also
seeks public comment regarding the
updating of fees for determination of
program compliance and additional fees
SUMMARY:
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for laboratories established under the
CLIA regulations. We are also seeking
public comment regarding the collection
of other fees we are authorized to collect
such as fees for revised certificates, post
survey follow-up visits, complaint
investigations, and activities related to
imposition of sanctions.
We intend to consider public
comments (including information such
as evidence, research, and trends)
received in response to this request for
information when we draft proposals, in
consultation, as appropriate, with the
Centers for Disease Control and
Prevention (CDC), to update the existing
CLIA regulations through future
rulemaking. We are also soliciting
public comment on other areas of CLIA
which should be reviewed and
potentially updated.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on March 12, 2018.
ADDRESSES: In commenting, refer to file
code CMS–3326–NC. Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3326–NC, P.O. Box 8016,
Baltimore, MD 21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3326–NC,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments ONLY to the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW, Washington,
DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
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readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–7195 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
FOR FURTHER INFORMATION CONTACT:
For general questions, please contact
Caecilia Blondiaux, 410–786–2190.
For personnel requirements, please
contact Sarah Bennett, 410–786–3354.
For proficiency testing referral, please
contact Sarah Bennett, 410–786–3354.
For histocompatibility, please contact
Penelope Meyers, 410–786–3366.
For CLIA fees, please contact Cindy
Flacks, 410–786–6520.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following
website as soon as possible after they
have been received: https://
www.regulations.gov. Follow the search
instructions on that website to view
public comments.
jstallworth on DSKBBY8HB2PROD with PROPOSALS
I. Background
A. Personnel Requirements
Generally, the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) regulations related to personnel
requirements have not been updated
since 1992, with the exception of minor
changes to doctoral high complexity
laboratory director qualifications in
2003 (see 68 FR 3713). We are soliciting
public comments (including
information such as evidence, research,
and trends) and intend to draft
proposals, to update the existing CLIA
personnel regulations through future
rulemaking. The topics listed in this
request for information are areas that the
Centers for Disease Control and
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Prevention (CDC), CMS, stakeholders
and State Agency surveyors identified
as concepts that should be relevant to
our efforts to update the CLIA personnel
requirements to better reflect current
knowledge, changes in the academic
context and advancements in laboratory
testing. Therefore, prior to starting the
rulemaking process, we are seeking
public comments (including
information such as evidence, research,
and trends), including stakeholder and
surveyor feedback, specific to the topics
discussed in this request for
information. We intend to consider any
such comments when we draft
proposals to update the existing CLIA
personnel regulations to better protect
public health and safety and reflect
current knowledge, changes in the
academic context, and advancements in
laboratory testing.
1. Nursing Degrees
As noted in Survey & Certification
Letter 16–18–CLIA1, we currently
consider a bachelor’s degree in nursing
to be equivalent to a bachelor’s degree
in biological science for purposes of the
educational requirements for moderate
and high complexity testing personnel
under CLIA. We are considering drafting
proposals to amend 42 CFR 493.1411
(moderate complexity technical
consultant), 493.1423 (moderate
complexity testing personnel), and
493.1489 (high complexity testing
personnel) to expressly reflect that
policy. We are also considering whether
a nursing degree should be considered
as a separate qualifying degree, as
opposed to the equivalent of a biological
science degree, for purposes of meeting
the educational requirements for
moderate and high complexity testing
personnel and technical consultants. As
such, we are also considering proposing
to amend §§ 493.1411, 493.1423, and
493.1489 to add a nursing degree as a
separate qualifying degree to the current
list of qualifying degrees for the
moderate and high complexity testing
personnel and technical consultants.
We are seeking public comments
(including information such as
evidence, research, and trends) related
to whether, for purposes of meeting the
educational requirements for moderate
complexity technical consultants and
testing personnel and high complexity
testing personnel, §§ 493.1411,
493.1423, and 493.1489 should be
amended: (1) To expressly reflect that a
nursing degree is equivalent to a
1 Survey & Certification Letter 16–18–CLIA SC
16–18–CLIA, S&C website: https://www.cms.gov/
Medicare/Provider-Enrollment-and-Certification/
SurveyCertificationGenInfo/Policy-and-Memos-toStates-and-Regions.html
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1005
biological science degree; or (2) to add
nursing degrees as a separate qualifying
degree (as opposed to the equivalent of
a biological science degree) to the
current list of qualifying degrees.
2. Physical Science Degrees
Due to variation in usage and the
absence of universally accepted
definitions, a ‘‘physical science degree’’
is difficult to define for regulatory
purposes. We note, however, that
physical science is a broad discipline
often described as the study of nonliving systems, such as astronomy,
physics, and earth sciences. Generally,
these types of degrees are not related to
clinical laboratory testing. We note that
in some instances, individuals with
these types of degrees have been able to
qualify as high complexity testing
personnel under § 493.1489.
We are seeking public comments
(including information such as
evidence, research, and trends) on what
is considered a physical science degree
and whether any physical science
degree(s) should be considered as
educational background(s) appropriate
for qualifying to meet the CLIA
educational requirements at
§§ 493.1405, 493.1411, 493.1423,
493.1443, 493.1449, 493.1461, and
493.1489.
3. Personnel Competencies
We recognize that the personnel
qualifications for general supervisors
may be less stringent than those of
technical consultants. However, the
current CLIA regulations allow general
supervisors with associate’s degrees
(§ 493.1461) to perform competency
assessment on high complexity testing
personnel (see §§ 493.1461(c)(2),
493.1489(b)(2)(i)), but because the
personnel requirements for moderate
complexity testing do not include the
general supervisor category, the same
general supervisors cannot perform
competency assessment on moderate
complexity testing personnel unless
they can meet the regulatory
qualifications of a technical consultant
(§ 493.1411). Technical consultants, at a
minimum, are required to have a
bachelor’s degree in chemical, physical,
or biological science or medical
technology. We recognize that high
complexity testing is inherently more
involved than moderate complexity
testing. We have received feedback from
laboratories and other stakeholders that
the difference in degree requirements to
qualify to assess competency presents
staffing challenges in laboratories. We
are seeking public comments (including
information such as evidence, research,
and trends) regarding whether general
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supervisors, with associate’s degrees,
should be allowed to perform
competency assessment for moderate
complexity testing personnel in
laboratories that perform both moderate
and high complexity testing.
4. Personnel Experience, Training and
Skills
Currently, when we refer to laboratory
training, experience and/or skills,2 we
mean that the individual qualifying has
the training in and the experience with
non-waived clinical laboratory testing or
in the specialties and subspecialties in
which the individual is performing
testing. Generally, the type of training
and experience required under the
current CLIA personnel regulation at
part 493, subpart M, is clinical in
nature. This means examination and test
performance on human specimens for
purposes of obtaining or providing
information for the diagnosis, treatment,
and monitoring of patients.
We are seeking public comments
(including information such as
evidence, research, and trends) on what
should be considered appropriate
laboratory training, experience and
skills when determining the
qualifications necessary for all 3
personnel to meet CLIA requirements,
and what comprises appropriate
documentation to verify the training,
experience and skills for all personnel
positions in part 493, subpart M.
jstallworth on DSKBBY8HB2PROD with PROPOSALS
5. Non-Traditional Degrees
Several current CLIA personnel
requirements allow a position to be
filled by an individual with a degree in
a ‘‘chemical, physical, biological or
clinical laboratory science, or medical
technology.’’ 4 We recognize there are
non-traditional degrees (for example,
Regents Bachelor of Arts) that may
include job experience in lieu of
coursework and that typically do not
include a major concentration of study
(for example, biology or chemistry), but
are instead classified as general
education degrees.
We are seeking public comments
(including information such as
evidence, research, and trends) related
to such non-traditional degrees,
specifically whether these types of
degrees should be considered to meet
the requirements for a chemical,
physical, biological or clinical
2 See §§ 493.1405, 493.1406, 493.1411, 493.1423,
493.1443, 493.1449, 493.1461, 493.1489, 493.1491.
3 See §§ 493.1405, 493.1406, 493.1411, 493.1423,
493.1443, 493.1449, 493.1461, 493.1489, 493.1491.
4 See §§ 493.1405, 493.1411, 493.1423,
493.1449(c) through (j) and (n) through (q),
493.1461, 493.1489.
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laboratory science, and/or medical
technology degrees.5
B. Proficiency Testing Referral
The Taking Essential Steps for Testing
Act (‘‘TEST Act’’) (Pub. L. 112–202,
enacted on December 4, 2012) amended
section 353 of the Public Health Service
Act (PHSA) to provide the Secretary
with discretion as to which sanctions
may be applied to cases of intentional
PT referral. Such discretion may in
some circumstances replace the
automatic revocation of the laboratory’s
CLIA certificate and subsequent
imposition of the 2-year ban on the
laboratory’s owner or operator, which
would prevent them from owning or
operating a CLIA-certified laboratory for
2 years.
1. Discretion for Category 1 PT Referral
The final rule entitled, ‘‘Medicare
Program; Prospective Payment System
for Federally Qualified Health Centers;
Changes to Contracting Policies for
Rural Health Clinics; and Changes to
Clinical Laboratory Improvement
Amendments of 1988 Enforcement
Actions for Proficiency Testing
Referral’’, published in the May 2, 2014
Federal Register (79 FR 25463 through
25467 and 25480 through 25481),
amended the regulations to implement
the TEST Act and provide the
prescriptive framework for the
application of sanctions in PT referral
cases (see also 79 FR 27106). These
regulations allow for a more appropriate
enforcement action based upon the
nature and extent of an intentional PT
referral violation and the penalties that
are imposed. These regulations include
three categories of sanctions for a PT
referral to be applied under certain
specified conditions, based on the
severity and extent of the violation.
These categories reserve revocation and
the resulting laboratory director/owner/
operator prohibition for the most
egregious violations while permitting
less serious sanctions in cases where
circumstances warrant.
‘‘Category 1’’, found at
§ 493.1840(b)(1), is for the most
egregious violations, encompassing
cases of repeat PT referral, regardless of
circumstances revolving around the
violation, and cases where a laboratory
reports another laboratory’s PT results
as its own to the PT program. This
category includes the revocation of the
laboratory’s CLIA certificate for at least
1 year, bans the owner and operator
from owning or operating a CLIA5 See §§ 493.1405, 493.1411, 493.1423,
493.1449(c) through (j) and (n) through (q),
493.1461, 493.1489.
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certified laboratory for at least 1 year,
and may include the imposition of a
civil money penalty (CMP). The
application of the owner exemption
from the ban is determined on a caseby-case basis (see § 493.1840(b)(1)(ii)).
We are seeking public comment
related to applying discretion in
situations where we determine that a
laboratory has referred its PT samples to
another laboratory and has reported the
other laboratory’s PT results as its own,
and under what circumstances the
discretion should be applied.
2. Alternative Sanctions for PT Referral
by CoW Laboratories
Section 353(d)(2)(C) of the PHSA
states that laboratories issued a CoW are
only exempt from subsections (f) and (g)
of the statute. All other subsections
apply, including the prohibition against
PT referral in subsection (i), which
refers to ‘‘any laboratory’’ that the
Secretary determines has intentionally
referred its PT samples. Therefore, CoW
laboratories that participate in PT are
not exempt from the ban against PT
referral. Per § 493.1775(b), CoW
laboratories may be inspected to
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,
evaluate a complaint, determine
whether the laboratory is performing
tests beyond the scope of its certificate,
or to collect information regarding the
appropriateness of tests specified as
waived tests. In addition, § 493.1775(c)
requires the laboratory to comply with
the basic inspection requirements of
§ 493.1773. However, the CLIA
regulations at § 493.1804(c)(1) state that
we do not impose alternative sanctions
on CoW laboratories because those
laboratories are not inspected for
compliance with condition-level
requirements. Therefore, our only
recourse in cases of PT referral found at
CoW laboratories are principal sanctions
(that is, revocation, suspension, or
limitation).
We are seeking public comments
(including information such as
evidence, research, and trends) to
determine if alternative sanctions
instead of principal sanctions should be
an option in these cases in order to
create parity for all certificate types for
laboratories determined to have
participated in PT referral.
C. Histocompatibility
Generally, the CLIA regulations
related to histocompatibility have not
been updated since 1992, with the
exception of certain changes in 2003
(see 68 FR 3640). We are soliciting
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public comment and intend to draft
proposals, to update the existing CLIA
histocompatibility regulations through
future rulemaking. The topics listed in
this request for information are areas
that CDC, CMS, the Clinical Laboratory
Improvement Amendments Advisory
Committee (CLIAC), and stakeholders
identified as concepts that should be
relevant to our efforts to update the
CLIA histocompatibility requirements to
better reflect current knowledge,
changes in transplant medicine, and
advancements in laboratory testing. We
intend to consider any such information
when we draft proposals to update the
existing CLIA histocompatibility
requirements to better protect the public
health and safety and reflect current
knowledge, changes in transplant
medicine, and advancements in
laboratory testing.
jstallworth on DSKBBY8HB2PROD with PROPOSALS
1. Crossmatching
As a result of changes in
histocompatibility testing technology
and practices, as well as advances in
organ transplantation since 1992, we
believe that some of the requirements
found at § 493.1278 have become
outdated and may preclude the use of
current transplantation practices. For
example, in some cases, performing a
‘‘virtual crossmatch’’ has replaced the
use of a ‘‘physical crossmatch’’ to
determine compatibility between the
donor and recipient.
The CLIA regulations require a
crossmatch to be performed as part of
the laboratory testing process (see 42
CFR 493.1278(e)). Although not
specified in the regulation, the
crossmatching procedures in use in
1992 were physical crossmatches (also
referred to as serologic crossmatches),
that is, a mixing of specimens from
donor and recipient to check for
compatibility. We understand that these
regulations are viewed by the
transplantation community as a barrier
to modernized decision-making
approaches on organ acceptability based
on risk assessment.
Virtual crossmatching generally refers
to an assessment of immunologic
compatibility based on the patient’s
alloantibody profile compared to the
donor’s histocompatibility antigens. In
virtual crossmatching, laboratory test
results already performed on donors and
recipients are compared in order to
predict compatibility and determine
whether an organ is acceptable for a
patient.
The CLIAC Virtual Crossmatch
Workgroup was convened to gather
information on the acceptability and
application of virtual crossmatching in
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lieu of serologic crossmatching for
transplantation.
The workgroup reported on advances
in the field of transplantation since the
CLIA regulations were published in
1992. These advances have made the
physical crossmatching less significant
or even obsolete in some cases.
Specifically:
• Histocompatibility testing has
evolved from cell based assays to
molecular typing and solid phase
platforms for antibody detection,
leading to improved accuracy,
sensitivity, specificity.
• Significant changes have occurred
in the clinical practice of
transplantation (for example,
immunosuppression, desensitization
practices), and improvements in antirejection therapies have led to improved
outcomes and mitigation of risk due to
antibodies against human leukocyte
antigens (HLA).
These advances have made virtual
crossmatching a viable alternative to
physical crossmatching. The Virtual
Crossmatch Workgroup presented a
report called the Acceptability and
Application of Virtual Crossmatching in
lieu of Serologic Crossmatching for
Transplantation,6 to the full CLIAC at its
November 2014 meeting. CLIAC
deliberated on the report and
recommended that we explore:
• Regulatory changes or guidance(s)
that would allow virtual crossmatching
to replace physical crossmatching as a
pre-requisite for organ transplant.
• Appropriate criteria and decisionmaking algorithms, based on the Virtual
Crossmatch Workgroup input provided
to CLIAC, under which virtual
crossmatching would be an appropriate
substitute for physical crossmatching.
The determination of appropriate
criteria and decision-making algorithms
should involve a process that includes
an open comment period.
We are seeking public comments
(including information such as
evidence, research, and trends) related
to these two CLIAC recommendations;
that is, whether virtual crossmatching
should be an acceptable alternative to
physical crossmatching, and under what
criteria and decision-making algorithms
virtual crossmatching would be an
appropriate substitute for physical
crossmatching.
6 The Acceptability and Application of Virtual
Crossmatching in lieu of Serologic Crossmatching
for Transplantation (2014) https://ftp.cdc.gov/pub/
CLIAC_meeting_presentations/pdf/Addenda/
cliac1114/8_BRAY_Virtual_Crossmatch_
Workgroup_Report_Nov-2014.pdf.
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2. Updating the Histocompatibility
Requirements
Since the CLIA specialty requirements
for histocompatibility testing were
initially finalized in 1992, there have
been many advancements in laboratory
testing. We believe that some of the
requirements found at § 493.1278 other
than those related to crossmatching may
also be outdated or are redundant with
other requirements found in subpart K
of the regulations. We are seeking public
comments (including information such
as evidence, research, and trends)
related to any histocompatibility
regulations that have become outdated,
and suggestions for updating the
histocompatibility regulations to align
with current laboratory practice.
D. CLIA Fees
With the exception of the certificate
fees notice which was published in the
August 29, 1997 Federal Register (62 FR
45915 through 45821), the CLIA
regulations related to fees have not been
updated since 1992, and we intend to
update the CLIA regulations with regard
to fees. These fee updates would
include the determination of program
compliance fees for laboratories holding
a Certificate of Compliance (CoC),
additional fees for laboratories holding
a Certificate of Accreditation (CoA), fees
for revised certificates, follow-up visits,
complaint investigations, and activities
related to the imposition of sanctions.
Section 353(m) of the PHSA requires
the Secretary to impose two separate
types of fees: ‘‘certificate fees’’ and
‘‘additional fees.’’ Certificate fees are
imposed for the issuance and renewal of
certificates (except that only a nominal
fee may be required for the issuance and
renewal of CoWs) and must be sufficient
to cover the general costs of
administering the CLIA program,
including and evaluating and
monitoring approved PT programs and
accrediting bodies and implementing
and monitoring compliance with
program requirements. Additional fees
are imposed for inspections of nonaccredited laboratories and for the cost
of performing PT on laboratories that do
not participate in approved PT
programs. The additional fees must be
sufficient to cover, among other things,
the cost of carrying out such inspections
and PT. Certificate and additional fees
must vary by group or classification of
laboratory, based on such
considerations as the Secretary
determines are relevant, which may
include the dollar volume and scope of
the testing being performed by the
laboratories. The regulations provide for
a methodology for determining
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compliance fee amounts (§ 493.649) and
periodic updating of the certificate fee
amounts (§ 493.638(b)).
jstallworth on DSKBBY8HB2PROD with PROPOSALS
1. Fees for Revised Certificate
The regulations also allow for
collection of fees for revised certificates
(§ 493.639). We are exploring an
appropriate methodology for
determining a fair and reasonable fee to
support these requests. At present,
laboratories may request a revised
certificate due to a change in name,
location, director, services offered (for
example, specialty or subspecialty), or
certificate type (for example, CoC to
Certificate of Provider-performed
Microscopy (PPM) Procedures). There is
a cost associated with such a request,
including staff time to verify and make
the edits in the data system, the
contractor’s time to print the revised
certificate, and the supplies required to
print the revised certificate. The fee for
revised certificate would likely be a
standard nominal fee for such requests.
2. Compliance Determination,
Additional Fees, and Methodology for
Determining Fee Amounts
Laboratories holding a CoC are subject
to fees for determination of program
compliance according to the regulations
at § 493.643(b). Laboratories that hold a
CoA are subject to additional fees as
outlined in § 493.645(b). As noted in
this request for information, the statute
requires certificate and additional fees
to vary by group or classification of
laboratory, based on such
considerations as the Secretary
determines are relevant, which may
include the dollar volume and scope of
the testing being performed by the
laboratories. Section 493.643(c) lists the
classifications, or schedules, of
laboratories based on the laboratory’s
scope and volume of testing. These
schedules are used to determine the fee
amount a laboratory is assessed and will
not be revised. The compliance
determination fees have not been
increased since the final rule was
published in 1992. The cost of
conducting compliance determination
activities (for example, surveys, PT
reviews, and evaluating personnel) has
increased over the life of the CLIA
program.
The regulations allow for us to collect
fees for follow-up visits post survey,
complaint investigations, and activities
associated with imposing sanctions.
Such fees for laboratories holding a CoC
are outlined in §§ 493.643(b) and
493.643(d), while laboratories holding a
CoA, CoW and a PPM Certificate are
subject to §§ 493.645(b)(2) and
493.645(c), as applicable. We are
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Jkt 244001
exploring methodology for assessing a
fair fee for these compliance
determination activities.
The methodology for determining fee
amounts is found in § 493.649. The
amount of the fee in each schedule for
compliance determination inspections
is based on the average hourly rate for
each entity, which includes costs to
perform required activities and
necessary administration costs. The
hourly rate is multiplied by the average
number of hours required to perform
these activities. We are seeking public
comments (including information such
as evidence, research, and trends) on an
alternate method to calculate the
average hourly rate for each entity as
outlined in § 493.649(b). We are also
seeking information on whether the
method should be standardized and
updated annually or as needed.
We are therefore soliciting public
comments (including information such
as evidence, research, and trends) on the
best method for instituting this
regulatory authority to collect CLIA fees.
II. Solicitation of Comments
This is a request for information only.
Respondents are encouraged to provide
complete but concise responses to the
questions listed in the sections outlined
below. Please note that a response to
every question is not required. This RFI
is issued solely for information and
planning purposes; it does not
constitute a Request for Proposal,
applications, proposal abstracts, or
quotations. This RFI does not commit
the Government to contract for any
supplies or services or make a grant
award. Further, we are not seeking
proposals through this RFI and will not
accept unsolicited proposals.
Responders are advised that the U.S.
Government will not pay for any
information or administrative costs
incurred in response to this RFI; all
costs associated with responding to this
RFI will be solely at the interested
party’s expense. Not responding to this
RFI does not preclude participation in
any future procurement, if conducted. It
is the responsibility of the potential
responders to monitor this RFI
announcement for additional
information pertaining to this request.
Please note that we will not respond to
questions about the policy issues raised
in this RFI. We may or may not choose
to contact individual responders. Such
communications would only serve to
further clarify written responses.
Contractor support personnel may be
used to review RFI responses.
Responses to this notice are not offers
and cannot be accepted by the
Government to form a binding contract
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
or issue a grant. Information obtained as
a result of this RFI may be used by the
Government for program planning on a
non-attribution basis. Respondents
should not include any information that
might be considered proprietary or
confidential. This RFI should not be
construed as a commitment or
authorization to incur cost for which
reimbursement would be required or
sought. All submissions become
Government property and will not be
returned. We may publically post the
comments received, or a summary
thereof.
We are soliciting public input on the
following areas:
A. Clarifications of Degree(s)
• We are seeking public comment
related to whether a bachelor’s degree in
nursing should be considered
equivalent to a bachelor’s degree in
biological science or should be
considered a qualifying degree to meet
the CLIA requirements for moderate and
high complexity testing personnel as
well as for technical consultants.
• We are seeking public comment on
what is considered a physical science
degree and if a physical science degrees
have the educational backgrounds such
that all or some should to be considered
a qualifying degree to meet the intent of
the CLIA requirements at §§ 493.1405,
493.1411, 493.1423, 493.1443, 493.1449,
493.1461, and 493.1489.
• We are seeking public comment
related to non-traditional degrees (for
example, Regents Bachelor of Arts)
specifically whether any of these types
of degrees should be considered to meet
the requirements for a chemical,
physical, biological or clinical
laboratory science, and/or medical
laboratory technology degrees.
B. Other Requirements for CLIA
Personnel Categories
• We are seeking public comment
regarding whether general supervisors
should be allowed to perform
competency assessment for testing
personnel performing moderate
complexity testing in laboratories that
perform both moderate and high
complexity testing.
• We are seeking public comment on
what is appropriate laboratory training,
experience and skills when qualifying
all personnel to meet CLIA
requirements, and what comprises
appropriate documentation to verify the
training, experience and skills for all
personnel positions in part 493, subpart
M.
E:\FR\FM\09JAP1.SGM
09JAP1
Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Proposed Rules
C. Proficiency Testing Referral
• We are seeking public comment
regarding the feasibility of applying
alternative sanctions in cases of PT
referral that involve waived testing.
• We are seeking public comment
related to applying discretion in
situations where we determine that a
laboratory has referred its proficiency
testing samples to another laboratory
and has reported those results from
another laboratory as their own, and
under what circumstances should that
discretion be applied.
D. Histocompatibility
• Virtual crossmatching: We are
seeking public comment on the
acceptability and application of virtual
crossmatching in lieu of physical
crossmatching for transplantation.
• Criteria and decision making
algorithms: We are seeking public
comment on appropriate criteria and
decision algorithms under which virtual
crossmatching would be an appropriate
substitute for physical crossmatching.
We are also seeking public comment on
the existence of commonly accepted
current guidelines for virtual
crossmatching in histocompatibility.
• Updating histocompatibility
regulations: We are seeking public
comment on histocompatibility
regulations that are no longer necessary
because they are obsolete or redundant
with requirements found in other
sections of the CLIA regulations. We are
also seeking public comment on any
histocompatibility regulations that
should be modified to reflect current
practices.
jstallworth on DSKBBY8HB2PROD with PROPOSALS
E. CLIA Fees
• We are seeking public comments
(including information such as
evidence, research, and trends) on an
alternate method to calculate the
average hourly rate for each entity as
outlined in § 493.649(b). We are also
seeking comment on whether the
method should be standardized and
updated annually or as needed.
• We are seeking public comment on
a methodology that would set a fair and
reasonable fee for revised certificate
requests. We also seek comment as to
whether fees should be nominal and, if
nominal, whether such fee would cover
the costs associated with the task.
• We are seeking public comment to
update the fees for determination of
program compliance as well as
additional fees to accredited laboratories
as outlined in §§ 493.643(b) and
493.645(b) respectively. We are also
seeking comment on whether fees
collected should be subject to the same
VerDate Sep<11>2014
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Jkt 244001
ten schedules at § 493.643(c), and
whether they should change based on
any updates to the methodology for
determining the average hourly rate.
• We are seeking public comment on
exploring an appropriate methodology
for assessing a fair fee for other
compliance determination activities to
include performing follow-up visits,
complaint investigations, and activities
associated with imposition of sanctions.
We are also soliciting general
feedback from stakeholders on what
other areas of CLIA they would
potentially have recommendations for
changing.
Dated: August 18, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
III. Collection of Information
Requirements
50 CFR Part 660
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
However, section II of this document
does contain a general solicitation of
comments in the form of a request for
information. In accordance with the
implementing regulations of the
Paperwork Reduction Act of 1995
(PRA), specifically 5 CFR 1320.3(h)(4),
this general solicitation is exempt from
the PRA. Facts or opinions submitted in
response to general solicitations of
comments from the public, published in
the Federal Register or other
publications, regardless of the form or
format thereof, provided that no person
is required to supply specific
information pertaining to the
commenter, other than that necessary
for self-identification, as a condition of
the agency’s full consideration, are not
generally considered information
collections and therefore not subject to
the PRA. Consequently, there is no need
for review by the Office of Management
and Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
1009
RIN 0648–BH18
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Frm 00015
Fmt 4702
Sfmt 4702
[FR Doc. 2017–27887 Filed 1–5–18; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
[Docket No. 170901860–7999–01]
IV. Response to Comments
PO 00000
Dated: December 20, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and
Human Services.
Fisheries Off West Coast States;
Coastal Pelagic Species Fisheries;
Multi-Year Annual Catch Limits for the
Finfish Stocks in the Monitored Stock
Category
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule.
AGENCY:
NMFS issues this proposed
rule to amend the regulations governing
the fisheries for Coastal Pelagic Species
(CPS) off the West coast to include
annual catch limits (ACLs, which are
the maximum allowable fishing levels
for each year, for certain monitored
finfish stocks (jack mackerel, central
population of northern anchovy,
northern subpopulation of northern
anchovy) under the CPS Fishery
Management Plan (FMP). A final rule
published October 26, 2016, established
these ACLs for the 2017 fishing year
only; the purpose of this proposed rule
is to codify these ACLs so they remain
effective until revised through some
future rulemaking. If the ACL for any
one of these stocks is reached or
projected to be reached, then fishing for
that stock will be closed until it reopens
at the start of the next fishing season.
This rule is intended to conserve and
manage these stocks off the U.S. West
Coast.
SUMMARY:
Comments must be received by
February 8, 2018.
ADDRESSES: You may submit comments
on this document, identified by NOAA–
NMFS–2017–0155, by any of the
following methods:
• Electronic Submissions: Submit all
electronic public comments via the
Federal e-Rulemaking Portal. Go to
DATES:
E:\FR\FM\09JAP1.SGM
09JAP1
]]>Agencies
[Federal Register Volume 83, Number 6 (Tuesday, January 9, 2018)]
[Proposed Rules]
[Pages 1004-1009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27887]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 493
[CMS-3326-NC]
RIN 0938-ZB40
Request for Information: Revisions to Personnel Regulations,
Proficiency Testing Referral, Histocompatibility Regulations and Fee
Regulations Under the Clinical Laboratory Improvement Amendments of
1988 (CLIA)
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: This request for information seeks public comment regarding
several items related to Clinical Laboratory Improvement Amendments of
1988 (CLIA) personnel requirements and histocompatibility requirements,
which, with minor exception, have not been updated since 1992. We are
also seeking public comment regarding the flexibility to impose
alternative sanctions for laboratories issued a Certificate of Waiver
(CoW) determined to have participated in proficiency testing (PT)
referral. In addition, we are seeking public comment related to
appropriate sanctions in situations where we determine that a
laboratory has referred its PT samples to another laboratory and has
reported the other laboratory's result as their own.
This request for information also seeks public comment regarding
the updating of fees for determination of program compliance and
additional fees for laboratories established under the CLIA
regulations. We are also seeking public comment regarding the
collection of other fees we are authorized to collect such as fees for
revised certificates, post survey follow-up visits, complaint
investigations, and activities related to imposition of sanctions.
We intend to consider public comments (including information such
as evidence, research, and trends) received in response to this request
for information when we draft proposals, in consultation, as
appropriate, with the Centers for Disease Control and Prevention (CDC),
to update the existing CLIA regulations through future rulemaking. We
are also soliciting public comment on other areas of CLIA which should
be reviewed and potentially updated.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on March 12, 2018.
ADDRESSES: In commenting, refer to file code CMS-3326-NC. Because of
staff and resource limitations, we cannot accept comments by facsimile
(FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-3326-NC, P.O. Box 8016,
Baltimore, MD 21244-8016.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-3326-NC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses:
a. For delivery in Washington, DC-- Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not
[[Page 1005]]
readily available to persons without Federal government identification,
commenters are encouraged to leave their comments in the CMS drop slots
located in the main lobby of the building. A stamp-in clock is
available for persons wishing to retain a proof of filing by stamping
in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
FOR FURTHER INFORMATION CONTACT:
For general questions, please contact Caecilia Blondiaux, 410-786-
2190.
For personnel requirements, please contact Sarah Bennett, 410-786-
3354.
For proficiency testing referral, please contact Sarah Bennett,
410-786-3354.
For histocompatibility, please contact Penelope Meyers, 410-786-
3366.
For CLIA fees, please contact Cindy Flacks, 410-786-6520.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that website to
view public comments.
I. Background
A. Personnel Requirements
Generally, the Clinical Laboratory Improvement Amendments of 1988
(CLIA) regulations related to personnel requirements have not been
updated since 1992, with the exception of minor changes to doctoral
high complexity laboratory director qualifications in 2003 (see 68 FR
3713). We are soliciting public comments (including information such as
evidence, research, and trends) and intend to draft proposals, to
update the existing CLIA personnel regulations through future
rulemaking. The topics listed in this request for information are areas
that the Centers for Disease Control and Prevention (CDC), CMS,
stakeholders and State Agency surveyors identified as concepts that
should be relevant to our efforts to update the CLIA personnel
requirements to better reflect current knowledge, changes in the
academic context and advancements in laboratory testing. Therefore,
prior to starting the rulemaking process, we are seeking public
comments (including information such as evidence, research, and
trends), including stakeholder and surveyor feedback, specific to the
topics discussed in this request for information. We intend to consider
any such comments when we draft proposals to update the existing CLIA
personnel regulations to better protect public health and safety and
reflect current knowledge, changes in the academic context, and
advancements in laboratory testing.
1. Nursing Degrees
As noted in Survey & Certification Letter 16-18-CLIA\1\, we
currently consider a bachelor's degree in nursing to be equivalent to a
bachelor's degree in biological science for purposes of the educational
requirements for moderate and high complexity testing personnel under
CLIA. We are considering drafting proposals to amend 42 CFR 493.1411
(moderate complexity technical consultant), 493.1423 (moderate
complexity testing personnel), and 493.1489 (high complexity testing
personnel) to expressly reflect that policy. We are also considering
whether a nursing degree should be considered as a separate qualifying
degree, as opposed to the equivalent of a biological science degree,
for purposes of meeting the educational requirements for moderate and
high complexity testing personnel and technical consultants. As such,
we are also considering proposing to amend Sec. Sec. 493.1411,
493.1423, and 493.1489 to add a nursing degree as a separate qualifying
degree to the current list of qualifying degrees for the moderate and
high complexity testing personnel and technical consultants.
---------------------------------------------------------------------------
\1\ Survey & Certification Letter 16-18-CLIA SC 16-18-CLIA, S&C
website: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html
---------------------------------------------------------------------------
We are seeking public comments (including information such as
evidence, research, and trends) related to whether, for purposes of
meeting the educational requirements for moderate complexity technical
consultants and testing personnel and high complexity testing
personnel, Sec. Sec. 493.1411, 493.1423, and 493.1489 should be
amended: (1) To expressly reflect that a nursing degree is equivalent
to a biological science degree; or (2) to add nursing degrees as a
separate qualifying degree (as opposed to the equivalent of a
biological science degree) to the current list of qualifying degrees.
2. Physical Science Degrees
Due to variation in usage and the absence of universally accepted
definitions, a ``physical science degree'' is difficult to define for
regulatory purposes. We note, however, that physical science is a broad
discipline often described as the study of non-living systems, such as
astronomy, physics, and earth sciences. Generally, these types of
degrees are not related to clinical laboratory testing. We note that in
some instances, individuals with these types of degrees have been able
to qualify as high complexity testing personnel under Sec. 493.1489.
We are seeking public comments (including information such as
evidence, research, and trends) on what is considered a physical
science degree and whether any physical science degree(s) should be
considered as educational background(s) appropriate for qualifying to
meet the CLIA educational requirements at Sec. Sec. 493.1405,
493.1411, 493.1423, 493.1443, 493.1449, 493.1461, and 493.1489.
3. Personnel Competencies
We recognize that the personnel qualifications for general
supervisors may be less stringent than those of technical consultants.
However, the current CLIA regulations allow general supervisors with
associate's degrees (Sec. 493.1461) to perform competency assessment
on high complexity testing personnel (see Sec. Sec. 493.1461(c)(2),
493.1489(b)(2)(i)), but because the personnel requirements for moderate
complexity testing do not include the general supervisor category, the
same general supervisors cannot perform competency assessment on
moderate complexity testing personnel unless they can meet the
regulatory qualifications of a technical consultant (Sec. 493.1411).
Technical consultants, at a minimum, are required to have a bachelor's
degree in chemical, physical, or biological science or medical
technology. We recognize that high complexity testing is inherently
more involved than moderate complexity testing. We have received
feedback from laboratories and other stakeholders that the difference
in degree requirements to qualify to assess competency presents
staffing challenges in laboratories. We are seeking public comments
(including information such as evidence, research, and trends)
regarding whether general
[[Page 1006]]
supervisors, with associate's degrees, should be allowed to perform
competency assessment for moderate complexity testing personnel in
laboratories that perform both moderate and high complexity testing.
4. Personnel Experience, Training and Skills
Currently, when we refer to laboratory training, experience and/or
skills,\2\ we mean that the individual qualifying has the training in
and the experience with non-waived clinical laboratory testing or in
the specialties and subspecialties in which the individual is
performing testing. Generally, the type of training and experience
required under the current CLIA personnel regulation at part 493,
subpart M, is clinical in nature. This means examination and test
performance on human specimens for purposes of obtaining or providing
information for the diagnosis, treatment, and monitoring of patients.
---------------------------------------------------------------------------
\2\ See Sec. Sec. 493.1405, 493.1406, 493.1411, 493.1423,
493.1443, 493.1449, 493.1461, 493.1489, 493.1491.
---------------------------------------------------------------------------
We are seeking public comments (including information such as
evidence, research, and trends) on what should be considered
appropriate laboratory training, experience and skills when determining
the qualifications necessary for all \3\ personnel to meet CLIA
requirements, and what comprises appropriate documentation to verify
the training, experience and skills for all personnel positions in part
493, subpart M.
---------------------------------------------------------------------------
\3\ See Sec. Sec. 493.1405, 493.1406, 493.1411, 493.1423,
493.1443, 493.1449, 493.1461, 493.1489, 493.1491.
---------------------------------------------------------------------------
5. Non-Traditional Degrees
Several current CLIA personnel requirements allow a position to be
filled by an individual with a degree in a ``chemical, physical,
biological or clinical laboratory science, or medical technology.'' \4\
We recognize there are non-traditional degrees (for example, Regents
Bachelor of Arts) that may include job experience in lieu of coursework
and that typically do not include a major concentration of study (for
example, biology or chemistry), but are instead classified as general
education degrees.
---------------------------------------------------------------------------
\4\ See Sec. Sec. 493.1405, 493.1411, 493.1423, 493.1449(c)
through (j) and (n) through (q), 493.1461, 493.1489.
---------------------------------------------------------------------------
We are seeking public comments (including information such as
evidence, research, and trends) related to such non-traditional
degrees, specifically whether these types of degrees should be
considered to meet the requirements for a chemical, physical,
biological or clinical laboratory science, and/or medical technology
degrees.\5\
---------------------------------------------------------------------------
\5\ See Sec. Sec. 493.1405, 493.1411, 493.1423, 493.1449(c)
through (j) and (n) through (q), 493.1461, 493.1489.
---------------------------------------------------------------------------
B. Proficiency Testing Referral
The Taking Essential Steps for Testing Act (``TEST Act'') (Pub. L.
112-202, enacted on December 4, 2012) amended section 353 of the Public
Health Service Act (PHSA) to provide the Secretary with discretion as
to which sanctions may be applied to cases of intentional PT referral.
Such discretion may in some circumstances replace the automatic
revocation of the laboratory's CLIA certificate and subsequent
imposition of the 2-year ban on the laboratory's owner or operator,
which would prevent them from owning or operating a CLIA-certified
laboratory for 2 years.
1. Discretion for Category 1 PT Referral
The final rule entitled, ``Medicare Program; Prospective Payment
System for Federally Qualified Health Centers; Changes to Contracting
Policies for Rural Health Clinics; and Changes to Clinical Laboratory
Improvement Amendments of 1988 Enforcement Actions for Proficiency
Testing Referral'', published in the May 2, 2014 Federal Register (79
FR 25463 through 25467 and 25480 through 25481), amended the
regulations to implement the TEST Act and provide the prescriptive
framework for the application of sanctions in PT referral cases (see
also 79 FR 27106). These regulations allow for a more appropriate
enforcement action based upon the nature and extent of an intentional
PT referral violation and the penalties that are imposed. These
regulations include three categories of sanctions for a PT referral to
be applied under certain specified conditions, based on the severity
and extent of the violation. These categories reserve revocation and
the resulting laboratory director/owner/operator prohibition for the
most egregious violations while permitting less serious sanctions in
cases where circumstances warrant.
``Category 1'', found at Sec. 493.1840(b)(1), is for the most
egregious violations, encompassing cases of repeat PT referral,
regardless of circumstances revolving around the violation, and cases
where a laboratory reports another laboratory's PT results as its own
to the PT program. This category includes the revocation of the
laboratory's CLIA certificate for at least 1 year, bans the owner and
operator from owning or operating a CLIA-certified laboratory for at
least 1 year, and may include the imposition of a civil money penalty
(CMP). The application of the owner exemption from the ban is
determined on a case-by-case basis (see Sec. 493.1840(b)(1)(ii)).
We are seeking public comment related to applying discretion in
situations where we determine that a laboratory has referred its PT
samples to another laboratory and has reported the other laboratory's
PT results as its own, and under what circumstances the discretion
should be applied.
2. Alternative Sanctions for PT Referral by CoW Laboratories
Section 353(d)(2)(C) of the PHSA states that laboratories issued a
CoW are only exempt from subsections (f) and (g) of the statute. All
other subsections apply, including the prohibition against PT referral
in subsection (i), which refers to ``any laboratory'' that the
Secretary determines has intentionally referred its PT samples.
Therefore, CoW laboratories that participate in PT are not exempt from
the ban against PT referral. Per Sec. 493.1775(b), CoW laboratories
may be inspected to 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, evaluate a complaint, determine whether
the laboratory is performing tests beyond the scope of its certificate,
or to collect information regarding the appropriateness of tests
specified as waived tests. In addition, Sec. 493.1775(c) requires the
laboratory to comply with the basic inspection requirements of Sec.
493.1773. However, the CLIA regulations at Sec. 493.1804(c)(1) state
that we do not impose alternative sanctions on CoW laboratories because
those laboratories are not inspected for compliance with condition-
level requirements. Therefore, our only recourse in cases of PT
referral found at CoW laboratories are principal sanctions (that is,
revocation, suspension, or limitation).
We are seeking public comments (including information such as
evidence, research, and trends) to determine if alternative sanctions
instead of principal sanctions should be an option in these cases in
order to create parity for all certificate types for laboratories
determined to have participated in PT referral.
C. Histocompatibility
Generally, the CLIA regulations related to histocompatibility have
not been updated since 1992, with the exception of certain changes in
2003 (see 68 FR 3640). We are soliciting
[[Page 1007]]
public comment and intend to draft proposals, to update the existing
CLIA histocompatibility regulations through future rulemaking. The
topics listed in this request for information are areas that CDC, CMS,
the Clinical Laboratory Improvement Amendments Advisory Committee
(CLIAC), and stakeholders identified as concepts that should be
relevant to our efforts to update the CLIA histocompatibility
requirements to better reflect current knowledge, changes in transplant
medicine, and advancements in laboratory testing. We intend to consider
any such information when we draft proposals to update the existing
CLIA histocompatibility requirements to better protect the public
health and safety and reflect current knowledge, changes in transplant
medicine, and advancements in laboratory testing.
1. Crossmatching
As a result of changes in histocompatibility testing technology and
practices, as well as advances in organ transplantation since 1992, we
believe that some of the requirements found at Sec. 493.1278 have
become outdated and may preclude the use of current transplantation
practices. For example, in some cases, performing a ``virtual
crossmatch'' has replaced the use of a ``physical crossmatch'' to
determine compatibility between the donor and recipient.
The CLIA regulations require a crossmatch to be performed as part
of the laboratory testing process (see 42 CFR 493.1278(e)). Although
not specified in the regulation, the crossmatching procedures in use in
1992 were physical crossmatches (also referred to as serologic
crossmatches), that is, a mixing of specimens from donor and recipient
to check for compatibility. We understand that these regulations are
viewed by the transplantation community as a barrier to modernized
decision-making approaches on organ acceptability based on risk
assessment.
Virtual crossmatching generally refers to an assessment of
immunologic compatibility based on the patient's alloantibody profile
compared to the donor's histocompatibility antigens. In virtual
crossmatching, laboratory test results already performed on donors and
recipients are compared in order to predict compatibility and determine
whether an organ is acceptable for a patient.
The CLIAC Virtual Crossmatch Workgroup was convened to gather
information on the acceptability and application of virtual
crossmatching in lieu of serologic crossmatching for transplantation.
The workgroup reported on advances in the field of transplantation
since the CLIA regulations were published in 1992. These advances have
made the physical crossmatching less significant or even obsolete in
some cases. Specifically:
Histocompatibility testing has evolved from cell based
assays to molecular typing and solid phase platforms for antibody
detection, leading to improved accuracy, sensitivity, specificity.
Significant changes have occurred in the clinical practice
of transplantation (for example, immunosuppression, desensitization
practices), and improvements in anti-rejection therapies have led to
improved outcomes and mitigation of risk due to antibodies against
human leukocyte antigens (HLA).
These advances have made virtual crossmatching a viable alternative
to physical crossmatching. The Virtual Crossmatch Workgroup presented a
report called the Acceptability and Application of Virtual
Crossmatching in lieu of Serologic Crossmatching for
Transplantation,\6\ to the full CLIAC at its November 2014 meeting.
CLIAC deliberated on the report and recommended that we explore:
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\6\ The Acceptability and Application of Virtual Crossmatching
in lieu of Serologic Crossmatching for Transplantation (2014)
https://ftp.cdc.gov/pub/CLIAC_meeting_presentations/pdf/Addenda/cliac1114/8_BRAY_Virtual_Crossmatch_Workgroup_Report_Nov-2014.pdf.
---------------------------------------------------------------------------
Regulatory changes or guidance(s) that would allow virtual
crossmatching to replace physical crossmatching as a pre-requisite for
organ transplant.
Appropriate criteria and decision-making algorithms, based
on the Virtual Crossmatch Workgroup input provided to CLIAC, under
which virtual crossmatching would be an appropriate substitute for
physical crossmatching. The determination of appropriate criteria and
decision-making algorithms should involve a process that includes an
open comment period.
We are seeking public comments (including information such as
evidence, research, and trends) related to these two CLIAC
recommendations; that is, whether virtual crossmatching should be an
acceptable alternative to physical crossmatching, and under what
criteria and decision-making algorithms virtual crossmatching would be
an appropriate substitute for physical crossmatching.
2. Updating the Histocompatibility Requirements
Since the CLIA specialty requirements for histocompatibility
testing were initially finalized in 1992, there have been many
advancements in laboratory testing. We believe that some of the
requirements found at Sec. 493.1278 other than those related to
crossmatching may also be outdated or are redundant with other
requirements found in subpart K of the regulations. We are seeking
public comments (including information such as evidence, research, and
trends) related to any histocompatibility regulations that have become
outdated, and suggestions for updating the histocompatibility
regulations to align with current laboratory practice.
D. CLIA Fees
With the exception of the certificate fees notice which was
published in the August 29, 1997 Federal Register (62 FR 45915 through
45821), the CLIA regulations related to fees have not been updated
since 1992, and we intend to update the CLIA regulations with regard to
fees. These fee updates would include the determination of program
compliance fees for laboratories holding a Certificate of Compliance
(CoC), additional fees for laboratories holding a Certificate of
Accreditation (CoA), fees for revised certificates, follow-up visits,
complaint investigations, and activities related to the imposition of
sanctions.
Section 353(m) of the PHSA requires the Secretary to impose two
separate types of fees: ``certificate fees'' and ``additional fees.''
Certificate fees are imposed for the issuance and renewal of
certificates (except that only a nominal fee may be required for the
issuance and renewal of CoWs) and must be sufficient to cover the
general costs of administering the CLIA program, including and
evaluating and monitoring approved PT programs and accrediting bodies
and implementing and monitoring compliance with program requirements.
Additional fees are imposed for inspections of non-accredited
laboratories and for the cost of performing PT on laboratories that do
not participate in approved PT programs. The additional fees must be
sufficient to cover, among other things, the cost of carrying out such
inspections and PT. Certificate and additional fees must vary by group
or classification of laboratory, based on such considerations as the
Secretary determines are relevant, which may include the dollar volume
and scope of the testing being performed by the laboratories. The
regulations provide for a methodology for determining
[[Page 1008]]
compliance fee amounts (Sec. 493.649) and periodic updating of the
certificate fee amounts (Sec. 493.638(b)).
1. Fees for Revised Certificate
The regulations also allow for collection of fees for revised
certificates (Sec. 493.639). We are exploring an appropriate
methodology for determining a fair and reasonable fee to support these
requests. At present, laboratories may request a revised certificate
due to a change in name, location, director, services offered (for
example, specialty or subspecialty), or certificate type (for example,
CoC to Certificate of Provider-performed Microscopy (PPM) Procedures).
There is a cost associated with such a request, including staff time to
verify and make the edits in the data system, the contractor's time to
print the revised certificate, and the supplies required to print the
revised certificate. The fee for revised certificate would likely be a
standard nominal fee for such requests.
2. Compliance Determination, Additional Fees, and Methodology for
Determining Fee Amounts
Laboratories holding a CoC are subject to fees for determination of
program compliance according to the regulations at Sec. 493.643(b).
Laboratories that hold a CoA are subject to additional fees as outlined
in Sec. 493.645(b). As noted in this request for information, the
statute requires certificate and additional fees to vary by group or
classification of laboratory, based on such considerations as the
Secretary determines are relevant, which may include the dollar volume
and scope of the testing being performed by the laboratories. Section
493.643(c) lists the classifications, or schedules, of laboratories
based on the laboratory's scope and volume of testing. These schedules
are used to determine the fee amount a laboratory is assessed and will
not be revised. The compliance determination fees have not been
increased since the final rule was published in 1992. The cost of
conducting compliance determination activities (for example, surveys,
PT reviews, and evaluating personnel) has increased over the life of
the CLIA program.
The regulations allow for us to collect fees for follow-up visits
post survey, complaint investigations, and activities associated with
imposing sanctions. Such fees for laboratories holding a CoC are
outlined in Sec. Sec. 493.643(b) and 493.643(d), while laboratories
holding a CoA, CoW and a PPM Certificate are subject to Sec. Sec.
493.645(b)(2) and 493.645(c), as applicable. We are exploring
methodology for assessing a fair fee for these compliance determination
activities.
The methodology for determining fee amounts is found in Sec.
493.649. The amount of the fee in each schedule for compliance
determination inspections is based on the average hourly rate for each
entity, which includes costs to perform required activities and
necessary administration costs. The hourly rate is multiplied by the
average number of hours required to perform these activities. We are
seeking public comments (including information such as evidence,
research, and trends) on an alternate method to calculate the average
hourly rate for each entity as outlined in Sec. 493.649(b). We are
also seeking information on whether the method should be standardized
and updated annually or as needed.
We are therefore soliciting public comments (including information
such as evidence, research, and trends) on the best method for
instituting this regulatory authority to collect CLIA fees.
II. Solicitation of Comments
This is a request for information only. Respondents are encouraged
to provide complete but concise responses to the questions listed in
the sections outlined below. Please note that a response to every
question is not required. This RFI is issued solely for information and
planning purposes; it does not constitute a Request for Proposal,
applications, proposal abstracts, or quotations. This RFI does not
commit the Government to contract for any supplies or services or make
a grant award. Further, we are not seeking proposals through this RFI
and will not accept unsolicited proposals. Responders are advised that
the U.S. Government will not pay for any information or administrative
costs incurred in response to this RFI; all costs associated with
responding to this RFI will be solely at the interested party's
expense. Not responding to this RFI does not preclude participation in
any future procurement, if conducted. It is the responsibility of the
potential responders to monitor this RFI announcement for additional
information pertaining to this request. Please note that we will not
respond to questions about the policy issues raised in this RFI. We may
or may not choose to contact individual responders. Such communications
would only serve to further clarify written responses. Contractor
support personnel may be used to review RFI responses. Responses to
this notice are not offers and cannot be accepted by the Government to
form a binding contract or issue a grant. Information obtained as a
result of this RFI may be used by the Government for program planning
on a non-attribution basis. Respondents should not include any
information that might be considered proprietary or confidential. This
RFI should not be construed as a commitment or authorization to incur
cost for which reimbursement would be required or sought. All
submissions become Government property and will not be returned. We may
publically post the comments received, or a summary thereof.
We are soliciting public input on the following areas:
A. Clarifications of Degree(s)
We are seeking public comment related to whether a
bachelor's degree in nursing should be considered equivalent to a
bachelor's degree in biological science or should be considered a
qualifying degree to meet the CLIA requirements for moderate and high
complexity testing personnel as well as for technical consultants.
We are seeking public comment on what is considered a
physical science degree and if a physical science degrees have the
educational backgrounds such that all or some should to be considered a
qualifying degree to meet the intent of the CLIA requirements at
Sec. Sec. 493.1405, 493.1411, 493.1423, 493.1443, 493.1449, 493.1461,
and 493.1489.
We are seeking public comment related to non-traditional
degrees (for example, Regents Bachelor of Arts) specifically whether
any of these types of degrees should be considered to meet the
requirements for a chemical, physical, biological or clinical
laboratory science, and/or medical laboratory technology degrees.
B. Other Requirements for CLIA Personnel Categories
We are seeking public comment regarding whether general
supervisors should be allowed to perform competency assessment for
testing personnel performing moderate complexity testing in
laboratories that perform both moderate and high complexity testing.
We are seeking public comment on what is appropriate
laboratory training, experience and skills when qualifying all
personnel to meet CLIA requirements, and what comprises appropriate
documentation to verify the training, experience and skills for all
personnel positions in part 493, subpart M.
[[Page 1009]]
C. Proficiency Testing Referral
We are seeking public comment regarding the feasibility of
applying alternative sanctions in cases of PT referral that involve
waived testing.
We are seeking public comment related to applying
discretion in situations where we determine that a laboratory has
referred its proficiency testing samples to another laboratory and has
reported those results from another laboratory as their own, and under
what circumstances should that discretion be applied.
D. Histocompatibility
Virtual crossmatching: We are seeking public comment on
the acceptability and application of virtual crossmatching in lieu of
physical crossmatching for transplantation.
Criteria and decision making algorithms: We are seeking
public comment on appropriate criteria and decision algorithms under
which virtual crossmatching would be an appropriate substitute for
physical crossmatching. We are also seeking public comment on the
existence of commonly accepted current guidelines for virtual
crossmatching in histocompatibility.
Updating histocompatibility regulations: We are seeking
public comment on histocompatibility regulations that are no longer
necessary because they are obsolete or redundant with requirements
found in other sections of the CLIA regulations. We are also seeking
public comment on any histocompatibility regulations that should be
modified to reflect current practices.
E. CLIA Fees
We are seeking public comments (including information such
as evidence, research, and trends) on an alternate method to calculate
the average hourly rate for each entity as outlined in Sec.
493.649(b). We are also seeking comment on whether the method should be
standardized and updated annually or as needed.
We are seeking public comment on a methodology that would
set a fair and reasonable fee for revised certificate requests. We also
seek comment as to whether fees should be nominal and, if nominal,
whether such fee would cover the costs associated with the task.
We are seeking public comment to update the fees for
determination of program compliance as well as additional fees to
accredited laboratories as outlined in Sec. Sec. 493.643(b) and
493.645(b) respectively. We are also seeking comment on whether fees
collected should be subject to the same ten schedules at Sec.
493.643(c), and whether they should change based on any updates to the
methodology for determining the average hourly rate.
We are seeking public comment on exploring an appropriate
methodology for assessing a fair fee for other compliance determination
activities to include performing follow-up visits, complaint
investigations, and activities associated with imposition of sanctions.
We are also soliciting general feedback from stakeholders on what
other areas of CLIA they would potentially have recommendations for
changing.
III. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. However, section II of this document does contain a
general solicitation of comments in the form of a request for
information. In accordance with the implementing regulations of the
Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4),
this general solicitation is exempt from the PRA. Facts or opinions
submitted in response to general solicitations of comments from the
public, published in the Federal Register or other publications,
regardless of the form or format thereof, provided that no person is
required to supply specific information pertaining to the commenter,
other than that necessary for self-identification, as a condition of
the agency's full consideration, are not generally considered
information collections and therefore not subject to the PRA.
Consequently, there is no need for review by the Office of Management
and Budget under the authority of the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
Dated: August 18, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: December 20, 2017.
Eric D. Hargan,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2017-27887 Filed 1-5-18; 11:15 am]
BILLING CODE 4120-01-P
