Ward General Practice Clinic, DAB No. 1624 (1997)

Department of Health and Human Services

DEPARTMENTAL APPEALS BOARD

Appellate Division

In the Case of:

Ward General Practice Clinic,
Petitioner,

- v. -

Health Care Financing Administration

DATE: July 24, 1997
Docket No. C-96-443
Decision No. 1624


FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION


Ward General Practice Clinic (Petitioner) appealed a December 27, 1996
decision by Administrative Law Judge (ALJ) Steven T. Kessel. See Ward General
Practice Clinic, DAB CR451 (1996) (ALJ Decision). The ALJ affirmed the Health
Care Financing Administration's (HCFA's) determination to impose sanctions
against Petitioner pursuant to the Clinical Laboratory Improvement Amendments
of 1988 (CLIA). The ALJ determined that Petitioner's failure to comply with
CLIA requirements posed immediate jeopardy to patients and that Petitioner had
not corrected outstanding deficiencies. Consequently, Petitioner's CLIA
certification was revoked.

On appeal, Petitioner alleged three general errors of law and fact arguing
that it had submitted a satisfactory plan of correction, that HCFA had erred
by not allowing it to perform lower level testing and, thereby, continue
participation in Medicare and Medicaid and that the ALJ mistakenly relied upon
Petitioner's purported history of noncompliance in reaching his decision.

The record in this case consists of the record before the ALJ and the parties'
submissions in connection with Petitioner's appeal. Based on the analysis
below, we uphold the ALJ Decision in its entirety.

Statute and Regulations

CLIA (section 353 of the Public Health Service Act; 42 U.S.C. § 263a)
establishes requirements for all laboratories that perform clinical diagnostic
tests on human specimens and requires a federal certification scheme to be
applied to all such laboratories. See 42 C.F.R. § 493.1800(a)(2). CLIA
certification of a laboratory is dependent upon whether the laboratory meets
the conditions of coverage set out at 42 U.S.C. § 263a(f)(1)(E) and 42 C.F.R.
§§ 493.1 et seq., in addition to other CLIA requirements. Each "condition,"
as set forth in the statute and regulations, represents a major division of
laboratory services to be offered by the laboratory or required environmental
protections at the laboratory. A laboratory's failure to comply with even a
single condition represents a serious breakdown in one of the major health
care delivery or safety systems of the laboratory, all of which are critical
to ensuring the provision of acceptable health care services and essential for
purposes of the laboratory's operations. See definitions of Certificate of
compliance and Condition level deficiency at 42 C.F.R. § 493.2.

The CLIA statute and implementing regulations grant the Secretary broad
enforcement authority to ensure that laboratories remain in compliance with
CLIA requirements throughout the period of their CLIA certification. This
enforcement authority includes the use of principal sanctions affecting the
laboratory's ongoing operations (suspension, limitation, or revocation of the
CLIA certificate) where the laboratory is out of compliance with one or more
conditions of certification. Indeed, the CLIA statute expressly provides that
the Secretary may suspend or limit the CLIA certificate prior to a hearing in
some situations, and provides that an opportunity for a hearing in that
instance must be provided on an expedited basis. 42 U.S.C. § 263a(i)(2). The
legislative history discusses the purpose for pre-hearing sanctions as
follows:

The Committee included this prehearing exclusion to allow the
Secretary the opportunity to respond promptly to situations in
which a laboratory's failure to comply may sacrifice the integrity
of test results. Where this occurs or where a laboratory's
interference with the Secretary's ability to make a determination
about laboratory quality occurs, it is imperative that the
Secretary have the authority either to force prompt compliance or
to move quickly to protect the public health. The Committee has
been informed that, under current law, lengthy court proceedings
and appeals may interfere with the Secretary's ability to stop a
laboratory from operating irrespective of the seriousness of the
violations. The bill's requirement of a prompt opportunity for a
hearing is designed to limit the potential adverse effects on a
laboratory of such a pre-hearing determination by the Secretary and
to allow a timely airing of the issues.

H.R. Rep. No. 899, 100th Cong., 2nd Sess. 35 (1988), reprinted in 1988
U.S.C.C.A.N. 3828, 3856.

The enforcement authority also includes the use of alternative sanctions,
which include a directed plan of correction, state on-site monitoring, and
civil money penalties. With respect to a directed plan of correction, the
legislative history noted that:

[A] directed plan of correction would be particularly appropriate
where a laboratory is out of compliance . . ., but where imposition
of such a sanction in lieu of revocation, suspension or limitation
would not place the health of patients in jeopardy.

Id. at 3854.

Moreover, the preamble to the final regulations states that alternative
sanctions "offer laboratories the opportunity to come into compliance within a
specified period of time instead of immediately having their CLIA certificates
suspended, limited, or revoked, or their Medicare approval canceled." 57 Fed.
Reg. 7223 (Feb. 28, 1992) (emphasis added).

The enforcement scheme in the regulations at 42 C.F.R. Part 493, Subpart R,
affords HCFA broad discretion in selecting the appropriate sanction to meet
particular deficiencies identified in surveys of the operations of the
laboratories. Perhaps foremost among the factors HCFA must consider is
whether the deficiencies pose an "immediate jeopardy." 1/ When a
laboratory's deficiencies have been found to pose an immediate jeopardy, the
enforcement scheme contemplates that HCFA will require the laboratory to take
immediate action to remove the jeopardy. 42 C.F.R. § 493.1812. 2/ Further,
the regulations specifically provide that the determination by HCFA that a
laboratory's deficiencies pose immediate jeopardy is solely within HCFA's
discretion and is not subject to further review. 42 C.F.R. § 493.1844(c)(6).

In order to fulfill its statutory obligation to ensure that clinical
laboratories remain in compliance with CLIA requirements, HCFA contracts with
state health departments to conduct on-site surveys of the laboratories to
determine whether federal requirements are met. State surveyors conduct
federal surveys of laboratories pursuant to the detailed rules in 42 C.F.R.
Part 488 entitled "Survey and Certification Procedures." These regulations
recognize that "surveyors are professionals who use their judgment, in concert
with Federal forms and procedures, to determine compliance." 42 C.F.R. §
488.26(b)(3).

The preamble to the final regulations describes the respective roles of the
state surveyors and HCFA:

The surveyors . . . are laboratory professionals. They
are trained extensively by both HCFA and their
respective States in proper inspection techniques under
CLIA. They use their professional judgment and
expertise in making recommendations. . . . The
surveyors' recommendations are reviewed by the
supervisory staff of the State agency or other HCFA
agents, and are further reviewed by the HCFA Regional
Office (RO). The RO makes the final determination of
compliance or noncompliance and imposes the sanction(s)
that would in the


opinion of the RO, most likely precipitate correction.

57 Fed. Reg. 7224 (Feb. 28, 1992).

BACKGROUND

The following facts are undisputed. Petitioner is a clinical laboratory in
New Orleans, Louisiana. On July 18, 1996, the Louisiana Department of Health
and Hospitals subjected Petitioner to a CLIA recertification survey. The
survey found that Petitioner no longer met the requirements to perform testing
under CLIA due to deficiencies that represented immediate jeopardy to
Petitioner's patients. ALJ Decision at 5; HCFA Exhibit (Ex.) 2, at 1.

On July 29, 1996, HCFA notified Petitioner of its concurrence with the survey
findings. HCFA found the following conditions out of compliance:

Enrollment and Testing of Samples (42 C.F.R. § 493.801)

General Quality Control; Moderate Complexity or High
Complexity Testing, or any combination of these Tests
(42 C.F.R. § 493.1201)

Bacteriology (42 C.F.R. § 493.1227)

Routine Chemistry (42 C.F.R. § 493.1245)

Endocrinology (42 C.F.R. § 493.1247)

Urinalysis (42 C.F.R. § 493.1251)

Laboratories Performing Moderate Complexity Testing;
Laboratory Director (42 C.F.R. § 493.1403)

Laboratories Performing High Complexity Testing;
Laboratory Director (42 C.F.R. § 493.1441) and

Quality Assurance; Moderate Complexity or High
Complexity Testing, or any combination of these Tests
(42 C.F.R. § 493.1701).

HCFA Ex. 2, at 1.


Consequently, HCFA decided to --

(1) suspend Petitioner's CLIA certificate (effective
August 10, 1996) pursuant to 42 C.F.R. §
493.1840(d)(2)(i);

(2) propose revocation of Petitioner's CLIA certificate
pending a decision from an Administrative Law Judge, if
an appeal is filed, as provided by 42 C.F.R.
§ 493.1840(e)(1); and

(3) cancel Petitioner's approval to receive Medicare
payments for laboratory services, effective August 10.

HCFA Ex. 2, at 1.

HCFA notified Petitioner that failure to meet a condition of participation
precluded a laboratory's participation under CLIA. HCFA indicated that if
Petitioner submitted a plan of correction alleging credibly that it was
complying with the CLIA requirements, Petitioner would be resurveyed. If the
resurvey supported Petitioner's allegations of compliance, no sanctions would
be imposed. Id. at 3.

Petitioner timely submitted a plan of correction to HCFA in which it alleged
compliance with CLIA as of July 24, 1996. See HCFA Ex. 3. There, Petitioner
admitted that it had not been complying with CLIA requirements, but declared
that as of July 24 it was conducting only waived procedures and physician
performed testing. 3/ Id.

On August 8, 1996, HCFA informed Petitioner that its plan of correction did
not rectify the deficiencies identified in the recertification survey. HCFA
noted that CLIA contained no provisions permitting a laboratory to perform
only waived tests and PPM procedures in order to avoid the imposition of
sanctions associated with a failure to comply with CLIA requirements.
Consequently, HCFA stated its intention to impose the penalties described in
its July 29 letter to Petitioner. See HCFA Ex. 4; see also HCFA Ex. 2.
Petitioner timely appealed HCFA's sanctions to an ALJ.

The ALJ Decision upholding HCFA's sanctions is based on the following findings
of fact and conclusions of law (FFCLs):

1. HCFA or its designee is authorized to conduct a
validation inspection of any accredited or CLIA-exempt
laboratory.

2. Where HCFA or its designee conducts an inspection of
a laboratory and where, based on the inspection, HCFA
determines the laboratory to be deficient in complying
with CLIA requirements, HCFA may impose sanctions
against the laboratory.

3. Where HCFA determines that a laboratory is not
complying with a condition or conditions of
participation under CLIA, HCFA may impose sanctions
which may include: canceling the laboratory's approval
to receive Medicare payments for its services;
suspension of the laboratory's CLIA certificate; and
revocation of the laboratory's CLIA certificate.

4. Where HCFA determines that a laboratory's failure to
comply with a condition or conditions of participation
under CLIA poses immediate jeopardy to the health and
safety of patients, then HCFA may suspend the
laboratory's CLIA certificate prior to a hearing before
an administrative law judge concerning whether HCFA's
determination is authorized.

5. Where an administrative law judge upholds a
determination by HCFA to suspend a laboratory's CLIA
certificate, based on finding that the laboratory's
failure to comply with a condition or conditions of
participation under CLIA poses immediate jeopardy to the
health and safety of patients, then the suspension of
the laboratory's CLIA certificate shall become a
revocation of that certificate.

6. It is a matter of discretion whether a laboratory
that has been found not to be complying with a CLIA
condition or conditions of participation may be
permitted, in lieu of imposition of sanctions against
that laboratory, to change the nature of its operations
so as to provide only lower levels of testing.

7. Petitioner failed to comply with CLIA conditions of
participation stated at 42 C.F.R. §§ 493.801, 493.1201,
493.1227, 493.1245, 493.1247, 493.1251, 493.1403,
493.1441, and 493.1701.

8. Petitioner's failure to comply with CLIA conditions
of participation posed immediate jeopardy to the health
and safety of patients.

9. Petitioner did not correct its failure to comply
with CLIA conditions of participation.

10. Petitioner has a history of not complying with CLIA
requirements.

11. HCFA was authorized to impose sanctions against
Petitioner, including: canceling the Petitioner's
approval to receive Medicare payments for its services;
suspension of Petitioner's CLIA certificate; and
revocation of Petitioner's CLIA certificate.

12. It is reasonable to deny approval to Petitioner to
convert its operations to a lower level of testing, in
lieu of imposition of sanctions against Petitioner, in
light of the nature of Petitioner's failure to comply
with CLIA requirements, its history of noncompliance,
and its failure to correct its noncompliance.

ALJ Decision at 2-4.

Petitioner filed three exceptions to the ALJ Decision alleging generally
that --

1. [The ALJ Decision at page 6 states] . . . the plan
of correction does not explain how Dr. Ward [the
laboratory Director] intended to correct the
deficiencies that were identified . . . Agreeing not to
do the failed procedures, and move to a lesser
certificate, would certainly prevent doing procedures
improperly in the future. . . [T]his is a combined error
of fact and of law . . . .

2. [FFCL 6 contains] . . . a serious error of law . . .
[by finding that it] . . . "is a matter of discretion
whether a laboratory that has been found not to be
complying with a clear [sic] condition or conditions of
participation may be permitted, in lieu of imposition of
sanctions against that laboratory, to change the nature
of its operations so as to provide only lower levels of
testing." It is respectfully submitted that the
handbook provided by the Dallas regional office, dated
[M]arch, 1995 must be construed to . . . [allow] such
voluntary withdrawal. . . .

3. The ALJ makes an error in relying upon a purported
history of noncompliance to justify his decision. It is
submitted that if a history is to be included, then the
entire history of the Ward General Practice Clinics,
under both certificates must be considered.

Petitioner's Brief (Br.) at 2-3.

ANALYSIS

The standard of review on a disputed factual issue is whether the ALJ decision
is supported by substantial evidence in the record. The standard of review on
a disputed issue of law is whether the ALJ decision is erroneous.

As explained below, Petitioner's exceptions are without merit.

Plan of Correction Exception

Petitioner asserted that its proposal to discontinue the procedures cited as
deficient in the survey comprised a more than adequate plan of correction.
Petitioner noted that the tests to be performed under the plan of correction
were low level and that the individual involved in the deficient procedures
had been removed from the testing procedure. The low level tests would now be
performed by Dr. Ward. Generally, Petitioner argued that this approach
represented a reasonable business decision to downgrade the laboratory's
certification rather than incurring whatever expenses might be associated with
upgrading the laboratory to meet the standards for high level procedures.
Petitioner's Br. at 3-4.

The ALJ addressed this argument in his decision. He reasoned that the fact
that Petitioner converted the laboratory to waived tests and PPM procedures --

does not address the specific deficiencies identified by
HCFA. . . I do not find that Petitioner corrected its
deficiencies simply by ceasing to perform certain tests
and procedures. The deficiencies . . . not only
involved specific failures by Petitioner to comply with
protocols and safety procedures in performing certain
identified tests, they involved pervasive and systematic
failures by Petitioner to comply with quality control
procedures that apply to clinical laboratories. . .
Petitioner offers no assurance that it has corrected
these pervasive and systematic failures merely by
ceasing to perform certain tests.

ALJ Decision at 7-8.

Petitioner failed to provide any cogent basis for concluding that this
analysis is erroneous. As the ALJ noted, Petitioner did not deny that the
deficiencies cited in the recertification survey posed immediate jeopardy to
patients. See ALJ Decision at 7. Moreover, Petitioner did not dispute the
ALJ's finding that some of the deficiencies involved quality control
procedures which affected laboratory's overall operation. These deficiencies
would compromise Petitioner's ability to perform even the lower level tests.
They could not be corrected by Petitioner's merely ceasing to perform higher
level procedures that were also found to have deficiencies. This does not
mean that Petitioner was not free to cease performing high level procedures.
However, Petitioner clearly had to do something more to remove the inherent
danger to patients posed by the deficiencies which affected its overall
operation. 4/
Furthermore, Petitioner's argument ignores the fact that deficiencies were
found in the PPM procedures. See ALJ Decision at 3 and 9. 5/ Thus,
Petitioner's plan of correction was clearly unacceptable to the extent that it
proposed that Petitioner would continue performing PPM procedures.

Discretion as to Voluntary Withdrawal

Petitioner disputed FFCL 6, which states that it is a matter of discretion
whether a laboratory that has been found not to be complying with a CLIA
condition or conditions of participation may be permitted, in lieu of
imposition of sanctions against that laboratory, to change the nature of its
operations so as to provide only lower levels of testing.

Petitioner suggested that since the ALJ determined that the regulations were
silent "as to whether a laboratory . . . found not to be complying with CLIA
requirements may convert its operations to a lower level of testing in order
to avoid the imposition of sanctions . . . ." (ALJ Decision at 5), the ALJ
should have concluded that there was no bar to Petitioner converting its
operations. Petitioner also argued that 42 C.F.R. § 493.807 and the CLIA
Handbook (Petitioner Exhibit 5, at 3-4) 6/ specifically authorized it to
cease performing high level tests in order to avoid HCFA's sanctions.
Petitioner asserted that, since the sanctions imposed as a result of the CLIA
deficiencies are punitive in nature, due process and equal protection require
that the applicable regulations be construed so as to provide Petitioner the
benefit of the doubt. 7/ Petitioner finally asserted that, at the very
least, it should be afforded an opportunity "to undergo a second examination,
or present a new plan of correction." Petitioner Br. at 4-6.

Petitioner's reliance on the regulation at 42 C.F.R. § 493.807(a) is
misplaced. In pertinent part, the regulation indicates that a laboratory
which --

voluntarily withdraws its certification under CLIA . . .
must . . . demonstrate sustained satisfactory
performance on two consecutive proficiency testing
events . . . before HCFA will consider it for
reinstatement for certification and Medicare or Medicaid
approval in that specialty, subspecialty, analyte or
test.

42 C.F.R. § 493.807(a) (emphasis added).

This regulation does nothing to limit HCFA's discretion. While the regulation
appears to permit a laboratory to freely withdraw its certification to perform
one or more tests, the regulation gives HCFA full discretion in determining
whether the laboratory may be reinstated. Moreover, the regulation does not
even suggest that by withdrawing its certification as to some tests, a
laboratory may avoid sanctions for deficiencies which affect the overall
safety of its testing program.

Further, the CLIA Handbook sections submitted by Petitioner provide nothing
more than a general outline of the steps to be taken by a laboratory seeking
reinstatement under CLIA. Effectively, they lay out the process described in
42 C.F.R. § 493.807 in simpler terms. Certainly, the Handbook does not commit
HCFA to the particular course of action suggested by Petitioner.

Contrary to what Petitioner suggested, this is not a case of interpretation of
an ambiguous regulation. The ALJ correctly concluded that the statute and
regulations clearly authorize HCFA, in its discretion, to impose sanctions
based on the findings it made here. As discussed above, Congress specifically
granted HCFA wide-ranging enforcement powers in this area due to the potential
threat to public welfare posed by laboratories failing to meet the standards
set out in CLIA. See Center Clinical Laboratory, DAB No. 1526 (1995). These
enforcement powers are available to HCFA in the face of a laboratory's failure
to meet even a single condition. Id. at 4. Moreover, the sanctions Congress
authorized are not punitive, but have different purposes. See 45 C.F.R. §
493.1804(a).

Finally, there is neither a statutory nor regulatory basis for Petitioner's
suggestion that it be given another examination or chance to submit a new plan
of correction. HCFA certainly cannot be found to have abused its discretion
simply because it is unwilling to provide an opportunity for correction not
provided for by law. Moreover, in view of HCFA's finding of immediate
jeopardy, HCFA might reasonably have concluded that it was inadvisable for it
to offer an additional opportunity for correction.

Alleged History of Noncompliance

The ALJ found that Petitioner had a history of noncompliance (FFCL 10). The
ALJ then found reasonable HCFA's decision to deny approval to Petitioner to
convert its operations to a lower level of testing, in lieu of imposition of
sanctions against Petitioner, in light of the nature of Petitioner's failure
to comply with CLIA requirements, its history of noncompliance, and its
failure to correct its noncompliance (FFCL 12).

Petitioner argued that the ALJ erred in relying on Petitioner's history of
noncompliance. Petitioner did not dispute that if it had a history of
noncompliance, that history would be relevant in determining whether sanctions
were properly imposed. However, Petitioner asserted that there was "no real
history of noncompliance by Ward General Practice Clinics." Petitioner
alleged that it has held "two certificates for some time" and that the second
of these certificates has been unchallenged and provides proof of Petitioner's
ability to maintain the standards necessary for participation in Medicare and
Medicaid. Petitioner Br. at 6.

Petitioner's argument has no merit. The ALJ's determination that Petitioner
had a history of failing to comply with CLIA requirements was based on an
unchallenged affidavit by the HCFA

Region VI, Chief, Survey and Certification Review Branch. ALJ Decision at 8.
The affiant stated:

Two years ago [1994], the laboratory was found out of
compliance with CLIA regulations. Because this was a
physician office laboratory and the staff was not
familiar with CLIA regulations, the state surveyor
worked with the laboratory to help it achieve
compliance. However, the laboratory did not maintain
the compliance, instead the non-compliance escalated to
an immediate jeopardy level.

HCFA Ex. 5, at Par. 9.

Petitioner pointed to nothing in the record before the ALJ, nor did it submit
any additional evidence, which would refute this statement. Instead,
Petitioner made vague references to satisfactory surveys in connection with
its other license. However, even if there were no compliance-related issues
surrounding Petitioner's other license, this does not obviate the fact that
Petitioner had a history of noncompliance in terms of its operation of the
laboratory in question here, which was directly relevant to HCFA's decision to
deny approval for converting the laboratory's operation to a lower level of
testing.

CONCLUSION

Based on the foregoing analysis, we sustain the ALJ Decision in its entirety.
We affirm and adopt each of the FFCLs in the ALJ Decision.


_________________________
Judith A. Ballard


_________________________
M. Terry Johnson


_________________________
Donald F. Garrett
Presiding Board Member


* * * Footnotes * * *

1. "Immediate jeopardy" is defined in the regulations as:

[A] situation in which immediate corrective action is
necessary because the laboratory's noncompliance with one
or more condition level requirements has already caused,
is causing, or is likely to cause, at any time, serious
injury or harm, or death, to individuals served by the
laboratory or to the health or safety of the general
public.

42 C.F.R. § 493.2.
2. Concerning sanctions in an immediate jeopardy situation
the preamble to the final regulations states:

If the deficiencies are determined to pose immediate jeopardy
to the health and safety of individuals served by the
laboratory . . ., the sanctions imposed will, of
necessity, be more severe than those used in situations
which are less threatening, and will consist of at least
one principal sanction. When there is not immediate
jeopardy, alternative sanctions rather than principal
sanctions would be imposed first, thus allowing the
laboratory a longer period of time to come into
compliance.

57 Fed. Reg. 7224 (Feb. 28, 1992).

3. Petitioner's plan of correction did not explain the
terms "waived procedures" and "physician performed testing."
Consequently, the ALJ determined that Petitioner used these terms
referring to "waived tests" and "provider-performed microscopy
(PPM) procedures." CLIA regulations define waived tests as simple
laboratory examinations and procedures, cleared by the Food and
Drug Administration for home use, employing methodologies that are
so simple and accurate as to render the likelihood of erroneous
results negligible and posing no reasonable risk of harm to a
patient if performed incorrectly. 42 C.F.R. § 493.15. PPM
procedures are tests of moderate complexity (42 C.F.R.
§ 493.5(a)(2)) involving a test performed personally by a
physician, midlevel practitioner or dentist on a specimen obtained
during a patient's visit. 42 C.F.R. § 493.19(b)(1) i-iii. ALJ
Decision at 6. Examining the nature of PPM procedures as set out
in the regulations, the ALJ found that they were more than simple
risk free tests. Rather, there existed a potential for harm to
patients if the tests were not performed correctly. Moreover, the
ALJ also recognized that Petitioner was found deficient in
performing tests of moderate complexity. Id. at 6-7, 9.
4. The individual performing the deficient procedures was
Dr. Ward's wife. HCFA Ex. 6, at Par. 3. However, Petitioner did
not allege that Dr. Ward was unaware of these deficient procedures
prior to the CLIA survey. Since he at least tacitly condoned the
deficiencies, there is no assurance that the deficiencies would be
corrected simply by his personally performing all the tests.
5. As HCFA noted in its brief, laboratories eligible to
perform PPM examinations must meet "the applicable requirements in
subpart C or subpart D, and Subparts F, H, J, K, and M and P" of
Part 493. 42 C.F.R. § 493.19(e)(1); HCFA Br. at 3. The deficient
conditions of participation relied on by HCFA and cited by the ALJ
in FFCL 7 are found in 42 C.F.R. Part 493, Subparts H (§ 493.801),
K (§§ 493.1201, 493.1227, 493.1245, 493.1247 and 493.1251), M
(§§ 493.1403 and 493.1441) and P (§ 493.1701).
6. These two pages of the CLIA Handbook constituted
pages 3 and 4 of Petitioner's Exhibit 5 before the ALJ. On appeal
of the ALJ Decision, Petitioner resubmitted those pages as its
Appeal Exhibits 1 and 2. We refer to these documents as identified
by the ALJ.
7. Petitioner also protested the complete closure of its
laboratory as violative of its inherent right to function outside
the Medicare and Medicaid programs and interstate commerce. The
legislative history of the CLIA Amendments demonstrates why the
Amendments removed the prior exemption for laboratories that do not
send specimens across State lines. Congress considered these
laboratories "among the poorest performing . . . in the nation"
and "a serious threat" to public health. For that reason "and
because these laboratories purchase goods and services from
entities outside their home states, . . . such laboratories
necessarily affect interstate commerce." H.R. Rep. No. 899, 100th
Cong., 2nd Sess., 13-14 (1988), reprinted in 1988 U.S.C.C.A.N.
3828, 3834-35. Since we conclude that the CLIA statute and
regulations clearly authorize closure of the laboratory under the
conditions present here, Petitioner's assertions that the
applicable legal provisions may be constitutionally void are beyond
the scope of this Board's review.