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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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Dearborn Family Clinic, |
DATE: June 19, 2002 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Centers for Medicare & Medicaid Services
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Docket No.C-01-293
Decision No. CR919 |
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DECISION I sustain the determination of the Centers
for Medicare & Medicaid Services (CMS) (1)
to impose remedies against Petitioner, Dearborn Family Clinic, pursuant
to the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
§ 263a et seq. I. Background
Petitioner is a clinical laboratory that is located in Dearborn Hills, Michigan. Petitioner's laboratory director is Howard Wright, D.O. In November 1999, the American Association of Bioanalysts Proficiency Testing Service (AAB) notified the Michigan Department of Consumer and Industry Services (Michigan State survey agency) that Petitioner and Emil S. Sitto, M.D., & Associates, P.L.L.C. (Sitto), another Detroit area laboratory, had submitted duplicate proficiency testing (PT) results in 1999. The Michigan State survey agency requested and received authorization from CMS to conduct an unannounced complaint survey. The Michigan State survey agency conducted a complaint investigation of Petitioner to determine whether Petitioner was complying with CLIA requirements on February 8, 2000. Based on the results of the February 8, 2000 survey and a comparative analysis of the PT results submitted by Petitioner and Sitto, the Michigan State survey agency made findings which were referred to CMS. On October 25, 2000, CMS notified Petitioner that it had been found to be deficient in complying with CLIA requirements in that improper referral and/or collaboration and integration occurred during the first, second, and third PT testing events of 1999. In the October 25, 2000 notice CMS identified specific CLIA conditions and other statutory and regulatory requirements with which it asserted Petitioner had not complied, which are stated at 42 C.F.R.§§ 493.801 (proficiency testing), 493.1441 (laboratory director), and 493.1447 (laboratory technical supervisor). CMS advised Petitioner that it had determined to impose remedies against Petitioner which included cancellation of Petitioner's approval to receive Medicare payment for its services and revocation of Petitioner's CLIA certificate.
Petitioner timely requested a hearing, and the case was assigned to me for a hearing and a decision. CMS moved for summary disposition. CMS's motion was accompanied by ten exhibits marked as CMS Exs. 1 - 10 plus two declarations which I now label as CMS Exs. 11 and 12. Petitioner filed a brief in response. Attached to Petitioner's brief were three exhibits marked as P. Exs. 1 - 3. CMS filed a reply brief. In addition, the parties filed a stipulation of facts (SOF). Attached to the SOF were thirteen exhibits labeled A - 1, A - 2, and B - L which I have renamed Administrative Law Judge Exhibits (ALJ Exs.) 1 - 13. No objections were made to any of the exhibits. I am receiving into evidence CMS Exs. 1 - 12, P. Exs. 1 - 3, and ALJ Exs. 1 - 13
The parties filed a stipulation of facts that I relate below. At all relevant times Howard Wright, D.O. was designated Petitioner's
laboratory director. SOF 2. During the first, second, and third PT events
of 1999, Petitioner retained Robin L. Mills in the capacity of an independent
contractor as a part-time laboratory technician. SOF 3. Ms. Mills was
identified on the Laboratory Personnel Report as Petitioner's technical
supervisor. SOF 4. Both Petitioner and the Sitto laboratory used AAB as
a testing service. SOF 5. In 1999, AAB sent endocrinology and chemistry
PT samples to Petitioner on three occasions. On each of these occasions
AAB sent five samples of each substance, including samples for cholesterol,
HDL cholesterol, Thyroid Stimulation Hormone (TSH), and Free Thyroxine
(Free T4). SOF 7. Ms. Mills performed the PT at Petitioner during the
first, second, and third PT events for 1999 for TSH and Free T4. SOF 8.
Ms. Mills recorded the results of these tests on laboratory log sheets.
SOF 9; ALJ Exs. 2 - 4. Susan Rosenberg, a laboratory technologist, performed
the PT at Petitioner during the first, second, and third PT events for
1999 for, among other things, cholesterol and HDL cholesterol. SOF 10.
Ms. Rosenberg recorded the results of these tests on laboratory log sheets.
SOF 11; ALJ Ex. 5. In 1999, Petitioner did not normally test patient samples
for TSH and Free T4 twice except in circumstances in which there was a
concern regarding a test result. SOF 12. In those cases, Petitioner would
normally run such patient samples more than once. Id.
It was Petitioner's practice to report results of patient tests as they
were recorded in the laboratory log. SOF 13. Ms. Mills wrote a letter to the Laboratory Improvement Section of the State of Michigan dated February 17, 2000, in which she stated that:
SOF 14; ALJ Ex. 6.
On or about March 18, 1999, Ms. Mills tested five PT samples for TSH.
SOF 15. Ms. Mills reported the results of the tests of the five samples
of TSH in a laboratory log. SOF 16; ALJ Ex. 2. Petitioner reported PT
results for the five samples of TSH to AAB. SOF 17; ALJ Ex. 7. Ms. Mills
signed the report in the area designated for the technical supervisor.
SOF 17. The results (SOF 18) shown on the laboratory log and the results
(SOF 18) reported to AAB are as follows:
The TSH results for vial nos. 1, 3, 4,
and 5 that Petitioner reported to AAB were different from the results
Ms. Mills reported in her laboratory log at Petitioner. SOF 19. The results of 21 out of 25 endocrinology and chemistry tests in the first PT event of 1999 reported to AAB by Petitioner were identical to the results reported to AAB by Sitto. ALJ Exs. 6 - 8; SOF 20.
On or about June 15, 1999, Susan Rosenberg,
an employee at Petitioner, tested five PT samples for cholesterol. SOF
21. Ms. Rosenberg reported the results of the tests for the five samples
of cholesterol in a laboratory log. SOF 22; ALJ Ex. 5. Petitioner reported
PT results for five samples of cholesterol to AAB. SOF 23; ALJ Ex. 10.
Ms. Mills signed the report in the area designated for the technical supervisor.
SOF 23. The results (SOF 24) shown on the laboratory log and the results
(SOF 24) reported to AAB are as follows:
The cholesterol results for vial nos. 1 through 5 that Petitioner reported to AAB were different from the results Ms. Rosenberg reported in her laboratory log at Petitioner. SOF 25.
On or about June 17, 1999, Ms. Mills tested five PT samples for TSH.
SOF 26. Ms. Mills reported the results of the tests of the five samples
of TSH in a laboratory log. SOF 27; ALJ Ex. 3. Petitioner reported PT
results for the five samples of TSH to AAB. SOF 28; ALJ Ex. 10. Ms. Mills
signed the report in the area designated for the technical supervisor.
SOF 28. The results (SOF 29) shown on the laboratory log and the results
(SOF 29) reported to AAB are as follows:
The TSH results for vial nos. 1, 2, 3, 4, and 5 that Petitioner reported to AAB were different from the results Ms. Mills reported in her laboratory log at Petitioner. (2) SOF 30.
On or about June 17, 1999, Ms. Mills tested five PT samples for Free
T4. SOF 31. Ms. Mills reported the results of the tests of the five samples
of Free T4 in a laboratory log. SOF 32; ALJ Ex. 3. Petitioner reported
PT results for the five samples of Free T4 to AAB. SOF 33; ALJ Ex. 10.
Ms. Mills signed the report in the area designated for the technical supervisor.
SOF 33. The results (SOF 34) shown on the laboratory log and the results
(SOF 34) reported to AAB are as follows:
The Free T4 results for vial nos. 1, 2, 3, 4, and 5 that Petitioner reported
to AAB were different from the results Ms. Mills reported in her laboratory
log at Petitioner. (3) SOF 35. The results of 25 out of 25 endocrinology and chemistry tests in the second PT event of 1999 reported to AAB by Petitioner were identical to the results reported to AAB by Sitto. ALJ Exs. 9 -11; SOF 36.
On or about October 19, 1999, Ms. Mills tested five PT samples for TSH. SOF 37. Ms. Mills reported the results of the tests of the five samples of TSH in a laboratory log. SOF 38; ALJ Ex. 4. Petitioner reported PT results for the five samples of TSH to AAB. ALJ Ex. 12. Ms. Mills signed the report in the area designated for the technical supervisor. SOF 39. The results (SOF 39) shown on the laboratory log and the results (SOF 39) reported to AAB are as follows:
The TSH results for vial no. 4 that Petitioner reported to AAB was different from the results Ms. Mills reported in her laboratory log at Petitioner. SOF 41.
On or about October 19, 1999, Ms. Mills tested five PT samples for Free
T4. SOF 42. Ms. Mills reported the results of the tests of the five samples
of Free T4 in a laboratory log. SOF 43; ALJ Ex. 4. Petitioner reported
PT results for the five samples of Free T4 to AAB. SOF 44; ALJ Ex. 12.
Ms. Mills signed the report in the area designated for the technical supervisor.
SOF 44. The results (SOF 45) shown on the laboratory log and the results
(SOF 45) reported to AAB are as follows:
The Free T4 result for vial no. 2 that Petitioner reported to AAB was
different from the result Ms. Mills reported in her laboratory log at
Petitioner. SOF 46. The parties stipulated that in the first PT event of 1999 the
results of 21 of the 25 endocrinology and chemistry tests reported to
AAB by Petitioner were identical to the results reported to AAB by the
Sitto laboratory. ALJ Exs. 9, 12, 13; SOF 47. (4) II. Governing law CLIA requires, among other things, that the Secretary of the United States
Department of Health and Human Services (Secretary) establish certification
requirements for any laboratory that performs tests on human specimens
and certify, through the issuance of a certificate, that a laboratory
meets certification requirements. 42 U.S.C. § 263a. The Secretary published
regulations designed to implement the requirements of CLIA. These regulations
are contained in 42 C.F.R. Part 493. The CLIA regulations set forth the
conditions that all laboratories must meet in order to perform clinical
testing. The regulations also set forth enforcement procedures and hearings
and appeals procedures for those laboratories that are found to be noncompliant
with CLIA requirements. The regulations establish both conditions and standards
for participation under CLIA. Conditions of participation are set
forth as broadly stated general requirements which must be met in order
for a laboratory to qualify under CLIA. Standards of participation are
set forth as specific quality requirements which must be met by a laboratory
in order to meet the more general requirements of conditions of participation.
Standards are subparts of the more broadly stated conditions. A failure
by a laboratory to comply with one or more standards may be so serious
as to constitute failure to comply with the condition of which the standards
are subparts. The CLIA regulations authorize CMS or its designee (such as the Michigan
State survey agency) to conduct validation inspections of any accredited
or CLIA-exempt laboratory in order to determine whether the laboratory
is in compliance with CLIA requirements. 42 C.F.R. § 493.1780(a). The
regulations confer enforcement authority on CMS in order to assure that
laboratories comply with CLIA. 42 C.F.R. § 493.1800. Where CMS determines
that a laboratory is not complying with one or more CLIA conditions, CMS
may impose as remedies principal sanctions against the laboratory
which may include suspension and/or revocation of the laboratory's CLIA
certificate. 42 C.F.R. § 493.1806(a), (b). CMS may also impose alternative
sanctions against a noncompliant laboratory in lieu of or in addition
to principal sanctions. 42 C.F.R. § 493.1806(c). Additionally, CMS may
cancel a laboratory's approval to receive Medicare payments for its services
where the laboratory is found not to be complying with one or more CLIA
conditions. 42 C.F.R. § 493.1807(a). The regulations provide a noncompliant laboratory with the opportunity
to correct its deficiencies so that CMS may remove alternative sanctions
that have been imposed against that laboratory. 42 C.F.R. § 493.1810(e).
However, the regulations do not afford a laboratory the same opportunity
to have principal, as opposed to alternative, sanctions lifted. The regulation at 42 C.F.R. § 493.801 provides that laboratories cannot engage in inter-laboratory communications pertaining to PT results until after the due date by which a laboratory must report its results to the PT program. 42 C.F.R. § 493.801(b)(3). In addition, a laboratory must not refer PT samples or portions of PT samples to another laboratory for any analysis that it is certified to perform in its own laboratory. 42 C.F.R. § 493.801(b)(4); 42 U.S.C. § 263(a)(i). If a laboratory intentionally refers PT samples to another laboratory for analysis, its CLIA certificate must be revoked for at least one year. 42 C.F.R. § 493.801(b)(4); 42 U.S.C. § 263(a)(i)(4).
Further, 42 C.F.R. § 493.801(b) provides that a laboratory is to analyze
PT samples in the same manner as patient samples. Thus, PT samples must
be integrated with the laboratory's regular patient workload and the tests
must be performed by personnel who routinely do the testing using the
laboratory's routine testing method. 42 C.F.R. § 493.801(b)(1). The integration
of PT samples must be attested to by the laboratory director and the individual
who performs the testing. PT samples must be tested the same number of
times as routine patient samples are tested. 42 C.F.R. § 493.801(b)(2).
Records documenting each step taken in the testing of PT samples are required.
42 C.F.R. § 493.801(b)(5). The regulation at 42 C.F.R. § 493.1447 provides that a laboratory performing
high complexity testing have a technical supervisor meeting the qualifications
set out in 42 C.F.R. § 493.1449. Specifically, a technical supervisor
must have a bachelor of science degree and four years of experience. The
regulation at 42 C.F.R. § 493.1441 provides that a laboratory have a laboratory
director who provides management and direction in accordance with 42 C.F.R.
§ 493.1445. One of the responsibilities of a laboratory director is the
hiring of staff with appropriate education and experience or training. A laboratory that is dissatisfied with a determination by CMS to impose
sanctions against it may request a hearing before an administrative law
judge to contest CMS's determination. 42 C.F.R. § 493.1844. The standard
of proof that is employed at a hearing concerning CMS's determination
that a laboratory is not in compliance with CLIA conditions is preponderance
of the evidence. CMS has the burden of coming forward with sufficient
evidence to prove a prima facie case that the laboratory is not complying
with one or more CLIA conditions. The laboratory has the ultimate burden
of rebutting, by a preponderance of the evidence, any prima facie case
of noncompliance that is established by CMS. Edison
Medical Laboratories, Inc., DAB No. 1713 (1999); Hillman
Rehabilitation Center, DAB No. 1611 (1997). III. Issue, findings of fact and conclusions of law
The issue in this case is whether Petitioner failed to comply with one or more CLIA conditions of participation, thereby giving CMS the authority to impose remedies against Petitioner, including canceling Petitioner's approval to receive Medicare payments and revoking Petitioner's CLIA certificate.
I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each Finding below as a separate heading. I discuss each Finding in detail.
A threshold question in this case is whether summary disposition is appropriate.
Summary disposition is appropriate 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 Medical Center,
DAB No. 1763 (2001); 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 require testimony). Respondent 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 was no actual referral of PT samples to another laboratory
in that the vials containing the proficiency samples were not sent by
Petitioner to any other facility. However, CMS does not premise its arguments
on a physical transfer of the proficiency samples and never so alleges.
Petitioner bears the burden of showing that there are material facts that
are disputed. Id. 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. I have looked closely at the parties' arguments to decide whether there are disputed issues of material fact. There are no disputed material facts in this case. Essentially, the parties are relying on the same facts and are making legal arguments based on those facts.
The condition of participation that is stated at 42 C.F.R. § 493.801
requires that a clinical laboratory must enroll in a proficiency testing
program that meets defined criteria and which is approved by the United
States Department of Health and Human Services. Petitioner enrolled in
an approved proficiency testing program that is operated by AAB. Petitioner
received a group of proficiency testing samples from the AAB at regular
intervals each year. Other clinical laboratories who were enrolled in
the AAB proficiency testing program received the same samples at the same
time as Petitioner. I take notice of the fact that the AAB refers to each
mailing of samples to laboratories for proficiency testing as an "event."
Under the AAB program there are three testing events per year. The object of the proficiency testing exercise is for each participating
laboratory to test its samples independently as if they are patient specimens
and to report the results of its tests to the AAB Proficiency Testing
Service. The AAB scores the results for the tests that are performed for
each event and rates each laboratory's testing competency for that event
based on the scores that the laboratory obtains. There was no such thing as a single "correct" score on many of the proficiency
tests that Petitioner and other laboratories were asked to perform in
1999. The AAB accepts as "correct" many test scores that fall within a
range of possible scores because of the wide range of variables that are
involved in the testing process. Indeed, it is highly unlikely that two
laboratories performing proficiency tests would obtain identical test
results on multiple samples, given the wide range of variables that are
involved in the testing process. During all three PT events in 1999, Howard Wright, D.O., was laboratory
director and Robin L. Mills was the technical supervisor and additional
testing was performed by Susan Rosenberg. SOF 2 - 4. In 1999, Petitioner
and Sitto both participated in the AAB's testing program. SOF 5. Both
Petitioner and Sitto were to test the proficiency samples for total cholesterol,
triglycerides, TSH, Free T4, and HDL cholesterol. Both laboratories were
to test the five samples for each analyte. The evidence which supports my conclusion that Petitioner and Sitto colluded
with each other to produce nearly identical proficiency testing results
in 1999 includes the opinions of two experts whose declarations were supplied
as evidence by CMS. CMS Ex. 11; CMS Ex. 12. These experts are Dennis W.
Jay, Ph.D., DABCC, Technical Director of the AAB Proficiency Testing Service
(CMS Ex. 11) and Richard J. Benson, CLS, MT, who is employed as Chief,
Laboratory Improvement Section, Bureau of Health Systems, of the Michigan
State survey agency (CMS Ex. 12). I find these experts to be well-qualified
and their opinions to be persuasive. Their conclusions were based on their
training in their respective fields, their experience in those fields,
and on the evidence which pertained to the specific proficiency tests
that are at issue in this case. The likelihood of more than one laboratory arriving at the same value
for a proficiency test result is low due to the variables that are involved
in the testing process. In this case, for example, both facilities used
manual techniques for measuring and diluting both samples and reagents.
CMS Ex. 12 at 5. Reagents and samples were introduced into test tubes
by hand and timed by the individual performing the test. Id.
Therefore, test results are rarely reproduced exactly even when one person
performs the same test twice on the same sample in the same laboratory
with the same equipment. Id. Therefore, the acceptable range
of results for each sample has a broad range. Id.; CMS Ex. 11
at 3. Yet, Petitioner and Sitto reported identical scores for all five
samples of four analytes. Petitioner and Sitto submitted identical results
for 60 out of 60 tests - four analytes tested five times each, on three
different testing events in 1999. (5) CMS
Ex. 3; SOF 20, 36, 47. This gives rise to the inference that Petitioner
and Sitto colluded together to report these results. Dr. Jay stated in his declaration:
CMS Ex. 11 at 3. Dr. Jay concluded:
CMS Ex. 11 at 3. Mr. Benson came to the same conclusion in his declaration and emphasized
how particularly unlikely such an identity in results would be coming
from two different laboratories using manual testing methods. CMS Ex.
12. The evidence which I have discussed so far, in and of itself, is sufficient
to support the conclusion that Petitioner and Sitto colluded in 1999 to
produce nearly identical proficiency testing results. However, there exists
additional evidence which supports this conclusion. That additional evidence consists in part of evidence showing that the
PT results that Petitioner submitted to AAB were not consistent with Petitioner's
own records of its proficiency tests. Such evidence strongly supports
a conclusion that Petitioner manipulated its proficiency testing results
in order to submit results that conformed to those which were submitted
by Sitto. The SOF that the parties submitted to me clearly shows many
instances where the PT values shown on Petitioner's laboratory logs and
the PT values reported to AAB were different. For example in SOF 24, the
difference between Petitioner's laboratory logs and the PT results reported
to AAB can be seen in the cholesterol results of the second PT event of
1999. The value for the first vial on the laboratory log was 99 while
the result reported to AAB was 109. The value for the second vial on the
laboratory log was 212 while the result reported to AAB was 222. The value
for the third vial on the laboratory log was 145 while the result reported
to AAB was 155. The value for the fourth vial on the laboratory log was
193 while the result reported to AAB was 202. The value for the fifth
vial on the laboratory log was 109 while the result reported to AAB was
120. Further, the evidence establishes that the opportunity for collusion
existed. Both Petitioner and Sitto employed the same individual, Ms. Robin
L. Mills. Ms. Mills was identified as Petitioner's technical supervisor.
SOF 4. Ms. Mills also worked at Sitto, another laboratory that used the
AAB as a PT service during 1999. P. Br. at 6. As the SOF shows, Ms. Mills
reported the results of the PT samples in the laboratory logs in most
cases. SOF 16, 27, 32, 38, 43. However, in all cases in 1999, Ms. Mills
signed the report in the area designated as technical supervisor which
was sent to AAB containing the PT values. SOF 17, 23, 28, 33, 39, 44.
Finally, Ms. Mills admitted her wrongdoing in her letter to the State
of Michigan dated February 17, 2000 that I mentioned previously as part
of the recitation of the SOF the parties submitted to me. SOF 14; ALJ
Ex. 6. Petitioner does not deny any of the facts already discussed, however,
it blames the entire situation on Ms. Mills and numerous times calls her
a renegade lab technician, a liar and dishonest. Petitioner claims that
Dr. Wright was completely unaware of Ms. Mills' actions and characterizes
this entire situation as "minor deficiencies related to PT." P. Br. at
4. This argument is unavailing because a laboratory is responsible for
the acts of its employees, even when it is unaware of the employees' actions.
Melvin C. Murphy, M.D.,
P.C., DAB CR590 (1999); Thyroid Specialty Laboratory,
DAB CR501 (1997); Oakland Medical Group, P.C., DAB No.
1755 (2000). In addition, Dr. Wright, as laboratory director, was required
to attest to the propriety of the PT. 42 C.F.R. § 493.801(b)(5). It was
his responsibility to make sure that the PT was properly done. He failed
to do so. Had he simply compared the laboratory logs to the PT values
reported out to AAB, he would have been aware of this problem before the
results were reported out to the AAB. Here, Petitioner was guilty of a wholesale failure to comply with PT
requirements for all three events of 1999. Identical PT results of 60
out of 60 test results submitted by both Petitioner and Sitto coupled
with discrepancies between laboratory worksheets and PT results reported
to AAB, the opportunity for collusion and Ms. Mills' letter admitting
her wrongdoing, are persuasive evidence of collaboration/collusion between
Petitioner and Sitto. Petitioner has offered no evidence at all that rebuts
this showing of collusion. Thus, Petitioner was out of compliance with
the overall condition for participation in PT set forth in § 493.801.
CMS is therefore authorized to impose a principal sanction on the laboratory
because it is compliance with one or more CLIA conditions. Petitioner also argues that it is a victim of a flawed PT system because AAB sent out identical samples to each laboratory and did not scramble the method for identifying the PT samples. I am without authority to address Petitioner's argument regarding the established procedures for testing in this forum; however, by Dr. Wright's attestation to the propriety of the PT, required by 42 C.F.R. § 493.801(b)(5), it was his responsibility to make sure that the PT were properly done and reported out.
The standards for the CLIA condition of participation regarding testing
of proficiency testing samples set forth at 42 C.F.R. § 493.801 require
that a clinical laboratory must test proficiency test samples in the same
manner as it tests patients' specimens; must not engage in inter-laboratory
communications pertaining to the results of proficiency testing; and must
not refer proficiency testing samples to other laboratories for analysis.
42 C.F.R. § 493.801(b)(1), (3), and (4). Petitioner did not comply with
these standards during 1999. Documentary evidence establishes that Petitioner did not integrate the
testing of the PT samples with its regular workload and did not test the
PT samples the same number of times as patient samples. On February 8,
2000, Barbara Alspaugh, a surveyor employed by the Michigan State survey
agency, conducted a complaint survey of Petitioner. CMS Ex. 5. Ms. Alspaugh
photocopied pertinent laboratory records and determined that Petitioner
failed to test the PT samples the same number of times as it tested patient
samples. Mr. Benson also agreed with this conclusion. CMS Ex. 12. In 1999,
Petitioner did not normally test patient samples for TSH and Free T4 twice
except in circumstances in which there was a concern regarding a test
result. SOF 12. In those cases, Petitioner would normally run such patient
samples more than once. SOF 12. However, the PT samples for both TSH and
Free T4 were each run twice. ALJ Ex. 3. Therefore, Petitioner did not
test the PT samples the same number of times as it did the patient samples
in violation of 42 C.F.R. § 493.801(b)(2). The manner in which Petitioner performed proficiency testing - by performing
TSH and Free T4 tests twice, a practice it did not normally engage in,
and by colluding with an other laboratory to obtain a collectively determined
result - clearly was a departure from standard procedures for testing
patients' specimens and involved communicating with another laboratory
about the results of proficiency testing. This behavior was a violation
of 42 C.F.R. § 493.801(b)(1) and (3). I also find that Petitioner's conduct constitutes a violation of 42 C.F.R.
§ 493.801(b)(4) which prohibits intentional referral of testing samples
to another laboratory. In doing so, I reject Petitioner's argument that
§ 493.801(b)(4) is limited to cases where physical transfer of the testing
sample is established. The question of physical transport was addressed by an appellate panel in Oakland, DAB No. 1755 (2000). It concluded that, while use of the word "send" in the first sentence of 42 C.F.R. § 493.801(b)(4) indicates a physical transfer, that sentence was not presented as a definition of "intentional referral" but could be read as a separate prohibition. The appellate panel noted that the second sentence of that section states: "[a]ny laboratory that HCFA determines intentionally referred its proficiency testing samples to another laboratory for analysis will have its certification revoked for at least one year." Therefore, the appellate panel concluded as follows:
Oakland , DAB No. 1755, at 21 - 22. Consequently, I conclude that Petitioner violated 42 C.F.R. § 493.801(b)(4). That provision codifies a statutory provision, found at 42 U.S.C. § 263(a)(i)(4), requiring CMS to revoke Petitioner's CLIA certificate for at least one year.
If standard level deficiencies are sufficiently egregious, they will
constitute a failure by a laboratory to comply with the overall condition
of which the standards are subparts. Boykansky, DAB No. 1756,
at 18 - 19. That is certainly the case here. I conclude that Petitioner's violation of the standards for testing of samples in a proficiency testing program set forth in 42 C.F.R. § 493.801(b) constitutes failure to comply with the condition of participation stated at 42 C.F.R. § 493.801. Petitioner's collusion in the performance of proficiency testing was a deliberate effort to frustrate the purpose of proficiency testing, which is to assure that a clinical laboratory establishes its competence through an impartial proficiency testing process. Petitioner's collusion was so egregious as to make its participation in a proficiency testing program meaningless. Petitioner's collusion undermined the integrity of the proficiency testing process for other laboratories. (6) Furthermore, such collusion by Petitioner meant that Petitioner was not performing its proficiency tests in the manner that it normally tested patients' specimens, was engaging in inter-laboratory communication about proficiency testing samples, and was referring proficiency testing samples to another laboratory. Because of these reasons, I reject as meritless Petitioner argument that CMS should impose a less onerous sanction than revocation of its CLIA certificate.
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). According to 42 C.F.R. § 493.1449, the minimum qualifications for a technical supervisor performing high complexity testing are a bachelor of science degree and four years of experience. A review of the personnel records showed that Ms. Mills, who was designated as the technical supervisor, had only an associate degree in applied science in violation of 42 C.F.R. § 493.1449. CMS Ex. 6 at 3; CMS Ex. 10.
42 C.F.R. § 493.1441 requires that a laboratory have a laboratory director who provides management and direction in accord with 42 C.F.R. § 493.1445. One of the responsibilities charged to the laboratory director under that section is the hiring of staff with the appropriate education and experience or training. As mentioned at Finding 5, Ms. Mills did not have the minimum educational requirements for being a technical supervisor. Therefore, the laboratory director failed in discharging the responsibility required of him under 42 C.F.R. § 493.1445.
CMS is authorized to impose principal sanctions, including revocation of a laboratory's CLIA certificate, as remedies for a laboratory's failure to comply with one or more CLIA conditions. 42 C.F.R. § 493.1806(a), (b). CMS may impose the additional remedy of cancellation of a laboratory's approval to receive Medicare payment for its services where the laboratory has not complied with one or more CLIA conditions. 42 C.F.R. § 493.1807. |
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Marion T. Silva Chief Administrative Law Judge
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1. The Health Care Financing Administration (HCFA) has been renamed the Centers for Medicare and Medicaid Services. Reference to either name shall apply to both names. 2. Although the parties stipulated that the TSH results reported to AAB in all five vials were different from those results reported on the laboratory log, I note that the TSH result reported to AAB in vial 3 was the same as the results on the laboratory log. In addition, the TSH result in vial 5 reported to AAB was different from the first result reported on the laboratory log but the same as the second result reported on the laboratory log. 3. Although the parties stipulated that the Free T4 results reported to AAB in all five vials were different from those results reported on the laboratory log, I note that the Free T4 result in vial 4 reported to AAB was different from the first result reported on the laboratory log but the same as the second result reported on the laboratory log. 4. I note that this last stipulation was at the very end of the SOF after the parties related the facts concerning the Free T4 results in the third PT event of 1999. Further, although the parties stipulated this, I note that the exhibits 9, 12, and 13 referred to by the parties are in actuality referring to the third PT event of 1999 not the first PT event of 1999. In addition, when these exhibits are examined as to the third PT event of 1999, it is obvious that 22 not 21 results out of 25 endocrinology and chemistry tests reported to AAB by Petitioner were identical to the results reported to AAB by Sitto. I, therefore, believe that the parties mistakenly repeated SOF 20 that referred to the first PT event in this portion of the stipulation of facts that should have referred to the third PT event. 5. CMS Ex. 3 shows a comparison of results submitted to the AAB by both Petitioner and Sitto for all three events in 1999. Both laboratories submitted results for each of five samples for cholesterol, triglycerides, TSH, Free T4 and HDL cholesterol for each event. This totals 75 results submitted from each laboratory. Out of the 75 results submitted to AAB, 68 were identical. However, when the results for HDL cholesterol are not included in this calculation, then 60 out of 60 results that were submitted to AAB by Petitioner and Sitto were identical. 6. As Dr. Jay states: When, as occurred here, multiple laboratories
reports [sic] PT results that were not obtained as required, i.e.,
through independent testing of samples in the same manner as patient samples
are tested, the integrity of the entire proficiency testing program is
undermined. This is because proficiency testing is graded on a "curve." To determine what constitutes a "passing
grade" for a particular analyte, results from laboratories using the same
methodology and equipment are grouped together. The average value reported
determines the range of "correct" responses. Because any collaboration
among laboratories necessarily skews the calculation of the average, collaboration
or referral corrupts the grading range against which all laboratories
in the given group are evaluated. Consequently, referral and collaboration
not only helps insure those who engage in this improper activity obtain
a passing grade, regardless of the quality of their proficiency testing;
but also may so disrupt the average values against which
all other similarly situated laboratories are rated. In addition, false
information concerning the reproducibility of the method is displayed
to the public who might want to use the information to evaluate the laboratory
testing materials that were used. CMS Ex. 11 at 3 - 4. |
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