Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
|IN THE CASE OF|
Gen Sys, Incorporated,
|DATE: April 15, 2002|
- v -
Centers for Medicare & Medicaid
| Docket No.C-00-007
Decision No. CR889
Summary judgment is entered affirming the determination of Respondent, Centers for Medicare & Medicaid Services (CMS), (1) suspending Petitioner's certificate of participation under the Clinical Laboratory Improvement Act (CLIA). Pursuant to 42 C.F.R. § 493.1844(d)(4)(ii), Petitioner's CLIA certificate is revoked effective the date of this decision due to the prior CMS suspension of the certificate based on a finding of immediate jeopardy. By operation of law, the owners and operators of Petitioner are prohibited from owning, operating, or directing a laboratory for two years pursuant to 42 U.S.C. § 263a(i)(3) due to the revocation of Petitioner's certificate. The two-year prohibition runs from the date of the revocation of the laboratory's certificate pursuant to 42 U.S.C. § 263a(i)(3) - the date of this decision. Summary judgment is appropriate as there are no genuine issues of material fact in dispute and the controlling issues may be resolved as a matter of law.
Gen Sys, Inc., is a clinical laboratory located in Aurora, Illinois. Petitioner
sought certification pursuant to CLIA to participate in the Medicare and
Medicaid program. On April 16, 1999, CMS and the Illinois Department of
Public Health personnel conducted an initial survey of Petitioner's laboratory
to determine compliance with applicable CLIA conditions and requirements.
The survey team noted both condition and standard level deficiencies and
Petitioner was notified accordingly. Upon the resignation of Petitioner's
director, Respondent declared that immediate jeopardy existed for the
public by virtue of Petitioner's continued operation and its CLIA certificate
was suspended effective August 3, 1999.
Petitioner timely requested a hearing on September 24, 1999. Petitioner disputed all findings of the survey of April 16, 1999 and the propriety of the suspension by Respondent. The request for hearing was received and the case was assigned to Judge Alfonso Montano for hearing. On November 22, 2000, Respondent filed its motion for summary affirmance. Petitioner filed is response to the motion on April 6, 2001, opposing summary judgment. Respondent replied on June 15, 2001. The case was reassigned to me for hearing and decision on October 18, 2001. I have jurisdiction and this case is ripe for decision on the issues set forth hereafter. I have decided that summary judgment is appropriate in this case and no hearing is necessary or required to make a full and complete adjudication.
has submitted 47 numbered exhibits and an affidavit from Stephen R. Wechter
executed April 6, 2001, which was attached to Petitioner's response to
CMS's motion for summary affirmance and which I marked as Petitioner's
exhibit 48 (P. Exs.1 - 48). Respondent made no objection to any of Petitioner's
exhibits and they are all admitted.
submitted 13 exhibits with its motion for summary affirmance and an additional
9 exhibits with its reply brief. The exhibits submitted with the opening
brief will be referred to as "R. Ex." and those submitted with Respondent's
reply will be referred to as "RR Ex." (2)
Although no objection was made by Petitioner, the first two pages of R. Ex. 1 are not admitted. It appears from the face of the first two pages of R. Ex. 1 that they are part of a statement of deficiencies and plan of correction for a survey of Heartland Manor at Carriage Town, Flint, Michigan that was completed February 12, 1999. The provider listed on the first two pages of R. Ex. 1 is not a party in this case. Therefore, those pages are irrelevant and are not admitted. The balance of the pages appear on their face to relate to Petitioner and, absent objection, they are admitted. (3)
specifically objects to the admission of: (1) R. Ex. 10, which purports
to be a "Consultants [sic] Final Report: William Komaiko, M.D. of ProbeLabs
to Gen Sys, Inc. 9/20/99; (2) R. Ex. 11, an unsigned, undated document
with the first page titled "The Corporation" and the remaining pages bearing
questions and answers purportedly related to Gen Sys, Inc.; and, (3) R.
Ex. 12, titled "Introduction to the Spirochetes." Petitioner's Response,
at 25, ¶ 73 - 76.
R. Ex. 11 is
not admitted because I cannot determine its authenticity. Counsel for
CMS represent in their reply brief at page 10 that the documents were
originally filed in a law suit in the State of Illinois and that they
are part of a public record. Although I may accept an assertion by counsel
as sufficient to establish authenticity of a document in some cases, counsel's
assertion is not sufficient in this case because the fact that counsel
retrieved the documents from the records of a civil litigation involving
Petitioner does not establish that Petitioner was the source of the documents.
CMS counsel have not revealed whether the State court accepted the documents
as authentic. Even if I accepted the documents as authentic, I would assign
them little weight without more certainty that they originated from Petitioner
and were unaltered.
R. Ex. 12 is
admitted. Authenticity is established by the website address which appears
at the bottom of each page of the document and the attribution found near
the middle of the second page. Although the document is admitted as authentic
and has some relevance due to its subject matter, it has no bearing on
my decision in this case.
Respondent's exhibits that are admitted are R. Ex. 1 (except pages 1 and 2), 2 through 10, 12, 13, and RR. Ex. 1 through 9. R.R. Exs. 6 and 8 are admitted as no objection was filed and they appear to be minimally relevant. However, these documents only indicate the pendency of criminal and civil cases involving some of the principals of Petitioner and do not indicate any findings of guilt or liability. Therefore R.R. Exs. 6 and 8 are given no weight and have no impact on my decision.
CLIA establishes requirements for all laboratories that perform clinical diagnostic tests on human specimens and provides for federal certification of such laboratories. Pub. L. No. 100-578, amending § 353 of the Public Health Service Act, codified at 42 U.S.C. § 263a et seq. The purpose of CLIA is to ensure the accuracy and reliability of laboratory tests, and hence the public health of all Americans. See H.R. Rep. No. 899, 100th Cong. 2d Sess. 8, 18 (1988), reprinted in 1988 U.S.C.C.A.N. 3828, 3839. CMS certification of a laboratory under CLIA is dependent upon whether the laboratory meets the conditions for certification set out in the statute and regulations. 42 U.S.C. § 263a(f)(1)(E); 42 C.F.R. § 493.1 et seq. Pursuant to CLIA, the Secretary of the Department of Health & Human Services (HHS) has broad enforcement authority, including the ability to suspend, limit, or revoke the certificate of a laboratory that is out of compliance with one or more requirements for certification.
has exercised his authority under 42 U.S.C. § 263a(f) and issued regulations
implementing CLIA. See 42 C.F.R. Part 493. The regulations specify
standards and the specific conditions of certification that a laboratory
must meet to achieve compliance. The regulations confer broad authority
on CMS to ensure that laboratories perform as Congress intended, including
authority to inspect and sanction laboratories that fail to comply with
the regulatory requirements. CMS has the delegated authority to suspend,
limit, or revoke the CLIA certificate of a laboratory that is out of compliance
with one or more CLIA conditions and may also impose alternative sanctions
such as a directed plan of correction or monitoring by the state. 42 C.F.R.
specify "conditions" and "standards" that laboratory's must meet and maintain
in order to obtain and retain their CLIA certification and their eligibility
to receive Medicare or Medicaid reimbursement. Title 42 C.F.R. §§ 493.1441
through 1445 provide an example. The condition specified at section 493.1441
is that a laboratory performing high-complexity testing, must have a laboratory
director who meets the qualifications of section 493.1443 and has the
duties specified in section 493.1445. Sections 493.1443 and 1445 are both
characterized as "standards" and each respectively lists in detail, required
qualifications and required duties for a laboratory director. Pursuant
to the enforcement provisions, CMS may impose principal or alternative
sanctions when it finds that a laboratory has a "condition-level" deficiency.
42 C.F.R. § 493.1804(b)(2). Principal sanctions include suspension, limitation,
or revocation of a CLIA certificate. 42 C.F.R. § 493.1806(b). Alternative
sanctions include a directed plan of correction, state on-site monitoring,
and civil money penalty. 42 C.F.R. § 493.1806(c). Cancellation and or
suspension of Medicare payments are also authorized. 42 C.F.R. § 493.1807.
If, on inspection,
a laboratory is found to have condition-level deficiencies that pose immediate
jeopardy, CMS must require immediate action to remove the jeopardy and
may impose alternative sanctions to assist. If the deficiencies remain
on revisit, CMS may suspend or limit and later revoke the laboratory's
CLIA certificate. CMS is also delegated authority to bring a civil suit
for injunction against a laboratory in specified circumstances where there
is immediate jeopardy. 42 C.F.R. § 493.1812. Condition-level deficiencies
that do not constitute immediate jeopardy and standard level deficiencies
that do not rise to condition level are treated differently and the laboratory
is generally accorded 12 months in which to make corrections. 42 C.F.R.
at 42 U.S.C. § 263a(i)(1) that a laboratory's certificate may be suspended,
revoked, or limited only after reasonable notice and opportunity for hearing
to "the owner or operator of the laboratory. . . ." The Secretary's regulations
provide that a laboratory or prospective laboratory dissatisfied with
an initial determination listed in 42 C.F.R. § 493.1844(b) is entitled
to a hearing before an Administrative Law Judge (ALJ). 42 C.F.R. § 493.1844(a).
CMS's decision to suspend, limit, or revoke a laboratory's certificate
due to noncompliance with CLIA requirements is an initial determination
that is subject to appeal and a hearing by an ALJ. However, the CMS determination
that condition-level deficiencies pose immediate jeopardy is not subject
to appeal or review. 42 C.F.R. §§ 493.1844(b)(1) and (c)(6). Generally,
the suspension, limitation, or revocation of a CLIA certificate is not
effective if appealed, until the ALJ makes a decision. However, when CMS
declares immediate jeopardy, there is no delay in the suspension, limitation,
or revocation of the offending laboratory's CLIA certificate. 42 C.F.R.
CLIA provides the following with respect to the owners and operators of noncompliant laboratories in addition to sanctions which may be imposed directly against a laboratory:
42 U.S.C. §
263a(i)(3). This statutory disability arises by operation of law immediately
upon revocation of a laboratory's certification. No action by the Secretary
is required, no discretion is granted the Secretary, and there is no appeal.
deficiencies are alleged in this case: (1) violation of 42 C.F.R. § 493.1227,
(2) violation of 42 C.F.R. § 493.1447, (3) violation of 42 C.F.R. § 493.1701,
and (4) violation of 42 C.F.R. § 493.1441. (5)
Section 1227 sets the conditions for bacteriology for laboratories. Section
1447 establishes conditions to be met by the individual holding the technical
supervisor position in a laboratory performing high complexity testing
with specific references to qualifications (42 C.F.R. § 493.1449) and
technical supervision of laboratory operations and personnel (42 C.F.R.
§ 1451). Section 1701 provides the condition that a laboratory must "establish
and follow written policies and procedures for a comprehensive quality
assurance program . . ." that cover all facets of the laboratory's operations.
Section 1441 establishes the conditions that must be met by the individual
holding the laboratory director position in a laboratory that performs
high complexity testing, including qualifications (42 C.F.R. § 1443) and
management responsibilities (42 C.F.R. § 493.1445).
OF FACT, CONCLUSIONS OF LAW AND ANALYSIS
The findings of fact and conclusions of law noted below are followed by a detailed discussion.
42 C.F.R. § 1844(f) it is presumed that Petitioner has a right to a hearing
in this case. See Garden City Medical Clinic, DAB No. 1763 (2001),
citing 42 U.S.C. § 263a(i)(1) and 42 C.F.R. § 493.1844(a). However, summary
judgment is appropriate and no hearing is required where either: there
are no disputed issues of material fact and the only questions that must
be decided involve application of law to the undisputed facts; or, the
moving party must prevail as a matter of law even if all disputed facts
are resolved in favor of the party against whom the motion is made. A
party opposing summary judgment must allege facts which, if true, would
refute the facts relied upon by the moving party. See e.g., Fed.
R. Civ. P. 56(c); Garden City, supra, Everett Rehabilitation
and Medical Center, DAB No. 1628, at 3 (1977) (in-person hearing
required where non-movant shows there are material facts in dispute that
has moved for summary judgment arguing it is entitled to judgment as a
matter of law as there are no material facts in dispute. Petitioner argues
that there are material facts in dispute as to every alleged deficiency
and that Petitioner was actually in compliance with all CLIA requirements.
CMS has alleged numerous deficiencies regarding specific standards in
addition to the four condition-level deficiencies. Certainly, it is not
unreasonable to assume that there are many disputed facts related to Petitioner's
scientific methods and its method of operation that could be the subject
of a hearing with voluminous exhibits and multiple experts. However, in
opposing Respondent's motion for summary judgment, Petitioner bears the
burden of showing that there are material facts that are disputed. Everett
Rehabilitation and Medical Center, DAB No. 1628 (1977). It is not
sufficient for Petitioner to rely upon mere allegations or denials to
defeat the motion and proceed to hearing. Petitioner must, by affidavits
or other evidence which set forth specific facts, show that there is a
genuine issue for trial. If Petitioner cannot show by some credible evidence
that there exists some genuine issue for trial, then summary judgment
is appropriate. Respondent must prevail as a matter of law. Moreover,
in this case the CMS citation of condition-level deficiencies makes Petitioner's
task of overcoming summary judgment even more burdensome. CMS imposed
the principal sanction of suspension of Petitioner's CLIA certificate
which will become a revocation of that certificate if I affirm the CMS
action. Any one of the four condition-level deficiencies if proved may
be sufficient to sustain the suspension by CMS. Therefore, if there is
no disputed, material fact and no genuine issue for trial as to one of
the condition-level deficiencies, summary judgment may be entered as to
that deficiency. The issue then is whether or not that one deficiency
is sufficient to support CMS' decision to impose the remedy, i.e., whether
the remedy is warranted given the deficiency.
I have carefully reviewed all the evidence and conclude that there are no material issues of fact regarding the condition-level violations of 42 C.F.R. §§ 1441 and 1447 and judgment should be entered for Respondent on those violations as a matter of law. (7) Petitioner has not met its burden of presenting and arguing some credible facts that show there is a genuine issue of material fact as to these condition-level violations. Petitioner requested an evidentiary hearing on the motion for summary judgment proposing to call several witnesses to testify. Petitioner's Response, at 24. The request for hearing is denied. Conducting an evidentiary hearing on a motion for summary judgment would defeat the purpose for summary judgment. Indeed, a finding that an evidentiary hearing was necessary would be tantamount to a denial of summary judgment. I further conclude that the condition-level violations of sections 1441 and 1447 are a sufficient basis for the suspension and revocation of Petitioner's CLIA certificate given the facts and circumstances in this case.
There is no
dispute that Stephen R. Wechter was the laboratory "technical supervisor"
when the April 16, 1999 survey was conducted. Respondent, determined based
on the survey of April 16, 1999, that Mr. Wechter did not meet the qualifications
for a "technical supervisor as required by 42 C.F.R. § 1447 and listed
at 42 C.F.R. § 1449. P. Ex. 1, at 10; Tag 6108. During the survey, Mr.
Wechter presented the surveyors with copies of diplomas and his curriculum
vitae (CV). P. Ex. 1, at 11. Mr. Wechter has provided copies of two diplomas
and his CV for my consideration at P. Ex. 11. Subsequent, to the on-site
survey, the surveyors further investigated Mr. Wechter's educational credentials
finding that the Eurotechnical Research University was, in 1992 when Mr.
Wechter's degree was conferred, operating from a post office box in Hilo,
Hawaii, and not accredited. P. Ex. 11 (diploma from Eurotechnical indicates
it was "conferred at Hilo, Hawaii" on June 15, 1992); R.R .Ex. 5. Mr.
Wechter asserts in the multiple affidavits filed in this matter and his
CV, that the Doctor of Philosophy conferred upon him by Eurotechnical
was in the area of immunology. P. Ex. 11 (diploma and CV); P. Exs. 14,
17, 23, 24, 29, 38, 45, 48. Respondent could not determine based upon
its investigation whether or not the Ph.D. was related to the area of
immunology and the diploma makes no mention of "immunology" on its face.
Respondent's investigation did disclose that Mr. Wechter's "post baccalaureate"
studies at the University of Houston in 1975, 1985, and 1986 were in the
area of history and no degree was conferred. P. Ex. 1, at 13. Mr. Wechter's
CV indicates he studied at the University of Houston but does not specify
the field of study but he asserts in his affidavit that his studies were
in the area of microbiology, biochemistry, chemistry, and organic chemistry.
Mr. Wechter's CV reflects an undergraduate degree from Columbia University
in New York awarded in 1982. His diploma indicates he was awarded a Bachelor
of Arts (B.A.) with honors in history ( P. Ex. 11), which is consistent
with the investigation of Respondent (P. Ex. 1). I will assume for purposes
of summary judgment that Mr. Wechter's Ph.D. was conferred in the area
of immunology - an inference drawn in Petitioner's favor. However, it
is the undisputed evidence in this case that the degree was conferred
by an unaccredited institution. Petitioner has presented no evidence,
even by way of affidavit, to show that the institution was accredited.
It is undisputed
that Mr. Wechter's education at Columbia where he received his B.A. was
in the area of history. Mr. Wechter asserts in his affidavit at P. Ex.
11 that his studies at the University of Houston in Texas were in microbiology,
biochemistry, chemistry and organic chemistry. Respondent's investigation
involved contact with the Registrar at the University of Houston who reviewed
University records and reported that Mr. Wechter's studies were in history.
P. Ex. 1, at 12-13. For purposes of ruling on summary judgment, I will
assume that Mr. Wechter's studies were in the areas he alleges, even though
he has presented no transcripts or other evidence to back his claim, an
inference drawn in Petitioner's favor. But, it is undisputed that Petitioner
received no degree from the University of Houston.
evidence on this point in a light most favorable to Petitioner, I see
that Mr. Wechter was issued a Ph.D. in the area of immunology. But there
is no dispute that the institution that issued the degree was unaccredited.
Mr. Wechter studied at the University of Houston in the areas he alleges.
But it is undisputed that he was awarded no degree for his work at the
University of Houston. Mr. Wechter received a B.A. degree from Columbia
University. But there is no dispute that his B.A. was in the area of history.
education requirement for a technical supervisor in a laboratory performing
high-complexity testing is a bachelor's degree from an accredited institution
in one of the specified science disciplines. 42 C.F.R. § 493.1449. Mr.
Wechter's only degree from an accredited institution is his B.A. from
Columbia University in the area of history. Thus, Mr. Wechter does not
meet the minimum education requirements for a technical supervisor.
never alleges in its pleadings or offers any evidence to show that Mr.
Wechter's Ph.D. was actually issued by an accredited institution. See
e.g. P. Ex. 2, at 4. Rather, Petitioner argues that "in an effort
to appease Respondent" Ellen Katz was hired to serve as technical supervisor.
Petitioner's Response, at 16, ¶ 40. On June 30, 1999, Ms. Katz signed
a list of technical supervisor duties. She was listed on a CLIA Laboratory
Personnel Report (Form HCFA-209) signed by the laboratory director Dr.
Janes bearing that same date. P. Ex. 4, Attachment 17 & 18. Nevertheless,
Mr. Wechter and not Ms. Katz signed the plan of correction dated July
8, 1999. P. Ex. 4. Although it is not possible to decide from the record
the date she left the position of technical supervisor, Petitioner concedes
in its brief that Ms. Katz left the position after only a brief period.
The fact that it was Mr. Wechter and not Ms. Katz who signed the plan
of correction on July 8, 1999, tends to indicate that: Ms. Katz never
assumed the responsibilities of the position; or that she was just listed
to "appease" CMS as counsel for Petitioner states and Mr. Wechter actually
continued to function as technical supervisor; or Ms. Katz resigned before
that date. However, viewing the evidence in a light most favorable to
Petitioner, I will conclude for purposes of this motion that Ms. Katz
actually held the position until around January 2000 when Petitioner prepared
a revised plan of correction that provided for the Laboratory Director
to assume the responsibilities of technical supervisor. P. Ex. 32. Contrary
to the assertions of Respondent, I find no statutory or regulatory requirement
for Ms. Katz to sign a HCFA Form 209 in order for her to become technical
supervisor for Petitioner. P. Ex. 5; CMS Reply Brief, at 9.
evidence in a light most favorable for the Petitioner, I conclude that
prior to April 16, 1999 and until June 30, 1999, while Stephen Wechter
was acting as technical consultant, Petitioner did not have a technical
supervisor who met the qualifications for that position. Thus, there was
a condition-level violation during this period. 42 C.F.R. § 1447 - 1449.
30, 1999 and until about January 2000, Ms. Ellen Katz was the technical
supervisor for the laboratory. She was qualified for the position. Thus,
there was no condition-level violation of 42 C.F.R. § 1447 during this
In January 2000, Petitioner provided by policy that in the absence of a qualified technical supervisor, the laboratory director would fulfill that function. P. Ex. 32. This policy is specifically permitted by 42 C.F.R. § 1449, so long as the laboratory director meets the qualifications for a technical supervisor. Petitioner has produced no evidence that a technical supervisor was hired after Ms. Katz and the evidence supports my conclusion, in light of Petitioner's adoption of its new policy, that the laboratory director would thereafter also be the technical supervisor. Thus, the laboratory had no technical supervisor when it had no laboratory director and a condition-level violation of 42 C.F.R. § 1447 occurred.
April 1999 survey, the laboratory director of Petitioner was William O.
Janes, M.D. P. Ex. 1. On June 9, 1999, Dr. Janes, as "Medical Director,"
signed the plan of correction for deficiencies found on the April 1999
survey. By letter dated June 25, 1999, Respondent advised Dr. Janes that
Petitioner's plan of correction was insufficient and that
continued with the three condition-level violations identified on the
original survey. P. Ex. 3. On July 8, 1999, Dr. Janes signed Petitioner's
revised plan of correction. P. Ex. 4. Dr. Janes resigned as the laboratory
director of Petitioner effective July 22, 1999. R. Ex. 4.
By letter dated
July 26, 1999, Respondent advised Petitioner that its CLIA certificate
would be suspended due to continuing condition-level violations and the
additional condition-level violation due to the resignation of Dr. Janes
as laboratory director. Respondent declared that immediate jeopardy existed.
Respondent was advised by letter dated August 3, 1999 from counsel for
Petitioner, that Petitioner had a new laboratory director, William Komaiko,
M.D. R. Ex. 7; P. Ex. 5. Nevertheless, Respondent persisted in finding
condition-level violations in (1) bacteriology (42 C.F.R. § 493.1227);
(2) laboratory technical supervisor (42 C.F.R. § 493.1447)
(10); and, (3) laboratory director (42 C.F.R. § 493.1441). Respondent
noted that Dr. Komaiko's qualifications and his assumption of the position
and duties were not properly documented as of August 20, 1999, the date
of the letter. By letter dated October 27, 1999, Dr. Komaiko advised Respondent
that he did not assume duties as laboratory director until August 10,
1999. He further advised that he was hired as a consultant and agreed
to assume laboratory director duties as part of his consulting contract
on an interim basis. He terminated his relationship about September 20,
1999, when he delivered his report to Petitioner. R. Ex. 10. Pravin H.
Patel, Ph.D. has submitted a letter that advises that he was never engaged
as laboratory director for Petitioner as represented in Petitioner's plan
of correction from February 2000 (P. Ex. 32), as his agreement to serve
was contingent upon CLIA approval which was not forthcoming. R.R. Ex.
4. By letter dated April 4, 2000, Respondent advised Petitioner that Dr.
Patel was not qualified to serve as laboratory director, but that he was
qualified to serve as technical supervisor. P. Ex. 6. Stephen Wechter
submitted a Form HCFA-209, dated May 24, 2000 and signed by James Bryant,
M.D. which reflects Dr. Bryant as laboratory director and technical supervisor.
P. Ex. 7. However, by letter dated June 5, 2000, Respondent advised Petitioner
that Dr. Bryant was ineligible to serve
Petitioner's laboratory director as he was already listed as laboratory
director for five other laboratories pursuant to 42 C.F.R. § 493.1445(d).
P.Ex. 8. Dr. Bryant resigned as director for one laboratory on July 25,
2000 and reported himself as laboratory director for Petitioner as of
August 7, 2000. P.Ex. 9.
The foregoing facts are undisputed, (see Petitioner's Response, at 24) and viewing the undisputed facts in a light most favorable to Petitioner, I make the following factual conclusions. Dr. Janes was laboratory director from on and before April 16, 1999, the date of the survey, to July 22, 1999. From July 23, 1999 until August 10, 1999, Petitioner had no laboratory director. From August 10, 1999 to September 20, 1999, Dr. Komaiko was Petitioner's laboratory director. From September 20, 1999 to August 7, 2000, Petitioner had no laboratory director. Dr. Bryant became Petitioner's laboratory director on August 7, 2000, and absent evidence to the contrary, I presume that he continues in that role. Therefore, during the 16-month period from April 16, 1999 to August 7, 2000, Petitioner had no laboratory director for nearly 12 months. Petitioner has presented no evidence or argument to the contrary. Petitioner was in violation of the condition-level requirement established by 42 C.F.R. § 1441 for each month it did not have a qualified laboratory director. I can conceive of no set of facts Petitioner could prove at trial that would lead to different conclusions more favorable to Petitioner.
Based on the
foregoing discussion, I am satisfied that from April 16, 1999 to June
30, 1999, Petitioner had no qualified technical supervisor. From June
30, 1999 to January 2000, Petitioner had a qualified technical supervisor
but after January 2000, Petitioner provided by policy that the technical
supervisor responsibilities were to be fulfilled by its laboratory director.
From September 20, 1999 to August 7, 2000, Petitioner had no laboratory
director. From January 2000 to August 7, 2000, Petitioner had neither
a qualified technical supervisor nor a qualified laboratory director.
Conversely, the only time during the 16-month period from April 16, 1999
to August 7, 2000, that Petitioner met the condition-level requirements
for laboratory director and technical supervisor, was from August 10,
1999 to September 20, 1999, during which period Ms. Katz was technical
supervisor and Dr. Komaiko was laboratory director. During the entire
period, August 10, 1999 to September 20, 1999, Petitioner's CLIA certificate
The final issue
is whether or not suspension and revocation are appropriate in this case
given the two condition-level violations I have found. Petitioner makes
no arguments regarding the propriety of the imposition of the principal
sanction of suspension. My review is de novo on this issue.
of either of the two condition-level deficiencies in this case is sufficient
to support the principal sanction of suspension and revocation of Petitioner's
CLIA certificate. The purpose of the Act is to ensure "the accuracy and
reliability of laboratory tests, and hence the public health of all Americans."
The absence of a qualified technical supervisor or a laboratory director
creates the significant risk of inaccuracy and unreliability detrimental
to the health of the American public. I can make this determination without
the need to assess the reliability of the many other allegations of irregularities
that surround the claims of this laboratory, its methods and operations
- allegations that I note were raised by those Petitioner retained as
laboratory directors. Petitioner has made no argument nor proffered any
evidence that would lead to a different result.
For the foregoing reasons, summary judgment is entered affirming the determination of Respondent suspending Petitioner's CLIA certificate. Pursuant to 42 C.F.R. 493.1844(d)(4)(ii), Petitioner's CLIA certificate is revoked effective the date of this decision due to the prior CMS suspension of the certificate based upon a finding of immediate jeopardy. By operation of law, the owners and operators of Petitioner are prohibited from owning, operating, or directing a laboratory for two years pursuant to 42 U.S.C. § 263a(i)(3) due to the revocation of the certification of the Petitioner. The two-year prohibition runs from the date of the revocation of the laboratory's certificate pursuant to 42 U.S.C. § 263a(i)(3) - the date of this decision.
Keith W. Sickendick
Administrative Law Judge
1. Effective July 5, 2001, the Health Care Finance Administration (HCFA) was renamed the Centers for Medicare and Medicaid Services (CMS). 66 Fed. Reg. 35437. Reference to either name applies to the same entity.
2. A much preferred practice is for subsequent exhibits to be numbered consecutively beginning with the number following that used on the last submitted exhibit, to avoid having multiple exhibits bearing the same exhibit number.
3. The complete Statement of Deficiencies has been admitted as part of P. Ex. 1.
4. It is interesting that Petitioner represented to CMS that Dr. Komaiko was hired as the laboratory director, curing one of its condition-level deficiencies. Dr. Komaiko, however, viewed himself only as a consultant retained to assist Petitioner to preserve its CLIA certificate. Of course, if Dr. Komiako was actually the laboratory director, R. Ex. 10 could be considered a vicarious admission of a party-opponent and/or an admission against interest.
5. The first three deficiencies were listed in the survey completed April 16, 1999 and are identified by Tags D4188, D6108, and D7000, respectively. P. Ex. 1. The fourth violation or deficiency arose when Petitioner's laboratory director, Dr. William O. Janes, resigned. CMS provided notice of the deficiency and of suspension of Petitioner's CLIA certificate based on a finding of "immediate jeopardy," by letter dated July 26, 1999. R. Ex. 6.
6. The CMS determination that "immediate jeopardy" existed is not subject to appeal or review. 42 C.F.R. § 493.1844(c)(6).
7. I note here that on further analysis of the other condition level violations I might also have found no genuine issues for trial. However, because the two deficiencies addressed are serious enough to justify the remedy imposed by CMS and the eventual revocation of the Petitioner's CLIA certificate, I see no reason to spend further time or resources upon an analysis of this case.
8. I feel it necessary to repeat that I am not ruling that CMS cannot prove the existence of other condition-level deficiencies in this case. My ruling is that: (1) there is no disputed issue of material fact as to the existence of the condition-level deficiencies discussed; and, (2) the two condition-level deficiencies found are a sufficient basis for suspending and revoking Petitioner's CLIA certificate.
9. I can only wonder why, if CMS doubted that Ms. Katz was actually performing as technical supervisor, it did not further investigate by visiting the laboratory or at least calling Ms. Katz.
10. For the reasons already discussed, I do not accept for purposes of ruling on summary judgment that a condition-level violation continued in the technical supervision area after Ms. Katz was appointed to that position June 30, 1999.