Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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IN THE CASE OF | |
Garden City Medical Clinic, |
DATE: September 11, 2000 |
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Health Care Financing Administration
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Docket No.C-99-766
Decision No. CR698 |
DECISION | |
I enter summary judgment in favor of the Health Care Financing
Administration (HCFA) sustaining its determination to impose remedies
against Petitioner, Garden City Medical Clinic, under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA). HCFA properly revoked Petitioner's
CLIA certificate for a period of one year. HCFA also properly canceled
Petitioner's approval to receive Medicare/Medicaid payment for its services,
effective September 11, 1999. I. Applicable Law and Regulations CLIA was designed to promote accurate medical tests by
clinical laboratories. Congress' goal was to establish a single set of
standards applicable to all laboratory services, including those provided
to Medicare beneficiaries. See H.R. Rep. No. 899, 100th
Cong., 2nd Sess. 8 (1988), reprinted in 1998 U.S.C.C.A.N.
3828. Under CLIA, the Secretary of the United States Department
of Health and Human Services (Secretary) is authorized to inspect clinical
laboratories and, in effect, license them to perform tests. The Social
Security Act (Act) prohibits a clinical laboratory from soliciting or
accepting specimens for testing unless it has first received from the
Secretary a certificate authorizing it to perform the specific category
of tests which the laboratory intends to perform. 42 U.S.C. 263a(b). The
Act directs the Secretary to establish standards to assure that clinical
laboratories certified by the Secretary perform tests that are valid and
reliable. 42 U.S.C. 263a(f)(1). The standards for the operation of clinical laboratories
promulgated by the Secretary pursuant to the enabling legislation are
found at 42 C.F.R. Part 493. 42 C.F.R. � 493.801 sets forth requirements
for performance of proficiency tests. A clinical laboratory must enroll
in an approved (PT) program. It must notify the Department of Health and
Human Services (DHHS) of each program or programs in which it chooses
to participate to meet proficiency testing standards. HCFA approves certain
companies to administer proficiency tests under CLIA. Sections 931 and
933 of Title 42 of the Code of Federal Regulations require that for routine
chemistry and endocrinology, three times each year at approximately equal
intervals, these approved testing companies send out proficiency test
samples to be analyzed by each laboratory. A minimum set of five samples
are sent for each testing event. The participating laboratories then perform
the tests and submit their results on forms provided by the testing services.
The testing services grade the results and report them to HCFA. To determine
the accuracy of a laboratory's response for qualitative and quantitative
chemistry tests or analytes, the program must compare the laboratory's
response for each analyte with the response that reflects agreement of
either 90 per cent of 10 or more referee laboratories or 90 per cent or
more of all participating laboratories.(1)
A laboratory is required to examine or test each PT sample that it receives
in the same manner that it tests patient specimens. 42 C.F.R. � 493.801(b). Any laboratory that the Secretary determines intentionally
refers its PT samples to another laboratory for analysis shall have its
certificate revoked for at least one year. 42 U.S.C. 263a(I)(4), 42 C.F.R.
� 493.801(b)(4). Additionally, the regulations provide that when HCFA
revokes a laboratory's CLIA certificate, it will also cancel that laboratory's
approval to receive Medicare reimbursement for services rendered. 42 C.F.R.
� 493.1842(a). A participating laboratory is required to test PT samples
in the same manner as patient specimens, as well as appoint a director
who provides overall management and direction in accordance with 42 C.F.R.
�� 493.801, 493.1441, and 493.1445. A laboratory that does not treat PT
samples in the same manner as patient samples or whose director fails
to provide overall management and direction may have its certificate of
accreditation revoked. 42 C.F.R. �� 493.61(b)(1) and 493.61(c)(3). It is also a violation of the regulations to engage in
any inter-laboratory communications pertaining to the results of proficiency
testing samples until after the date by which the facility must report
PT results to the proficiency testing service. 42 C.F.R. � 493.801(b)(3). The CLIA condition of participation at 42 C.F.R. � 493.803(a),
requires that a laboratory performing tests of moderate and/or high complexity
must successfully participate in a proficiency testing program. Reagents, solutions, culture media, control materials,
calibration materials, and other supplies must be prepared, stored, and
handled in a manner to ensure that they are not used beyond their expiration
date, have not deteriorated, nor are of substandard quality. 42 C.F.R.
� 493.1205(e)(1). 42 C.F.R. Part 493, Subpart E, requires HCFA or its agent
to conduct, on a representative sample basis or in response to substantial
allegations of non-compliance, surveys of an accredited laboratory as
a means of validating its performance. The regulations set forth "conditions" as well as "standards"
for participation under CLIA. While conditions are expressed as broad,
general requirements, standards are set forth as more specific requirements
of participation. A participating laboratory's failure to comply with
one or more standards may be so egregious as to constitute a failure to
comply with a condition of participation. If HCFA determines that a facility
has not complied with a condition of participation, it may impose principal
sanctions which include revocation and/or suspension of the laboratory's
CLIA certificate. 42 C.F.R. � 493.1806(a), (b). In lieu of, or in addition
to, principal sanctions HCFA may impose alternative sanctions. HCFA may
allow a non-compliant laboratory the opportunity to remove alternative
sanctions, but the regulations do not provide a laboratory the same opportunity
for removing principal sanctions. A laboratory that is not satisfied with the imposition
of remedies by HCFA may request a hearing before an administrative law
judge. 42 C.F.R. � 493.1844. II. Background HCFA filed a motion and memorandum of law accompanied
by documentation and written declarations in support of its motion for
summary judgment on January 12, 2000. Petitioner countered with an opposing
memorandum on February 21, 2000. It offered no supporting affidavits or
other documentation. HCFA submitted a reply brief on March 9, 2000. I
admit into evidence HCFA's Exhibits 1-18 (HCFA Exs. 1-18) which accompanied
its brief dated January 12, 2000. On June 27, 2000, Petitioner filed a
supplemental brief and four proposed exhibits. These have been admitted
into evidence as Petitioner's Exhibits 1-4 (P. Exs. 1-4). Petitioner is a physician office laboratory located in
Garden City, Michigan, that holds a CLIA certificate of accreditation.
(Identification Number 23D0367601.) HCFA Ex. 6. The laboratory engages
in high-complexity testing for routine chemistry. HCFA Ex. 7. Nazar Sarafa,
M.D. is Petitioner's laboratory director. HCFA Ex. 7. Deborah Sabo was
part of the testing personnel of Garden City's laboratory as well as other
laboratories in the Detroit Metro area. HCFA Ex. 7. She performed high
complexity routine chemistry testing for Petitioner as well as proficiency
testing. HCFA Exs. 7-10. Garden City Medical Clinic (Nazar Sarafa, M.D.); Oakland
(also known as Moretsky/Trager/Flor); John Dunn, M.D.; Mark Hertzberg,
M.D.; Rochester Rd. Clinic; Liptawat Family PC; Lakeland Medical; Ecorse
Med Center; and Stanley Boykansky, M.D. are some of the laboratories in
the Detroit Metro area participating in a PT program operated by the American
Association of Bioanalysts (AAB). HCFA Ex. 2. As participants in this
program, AAB would mail each laboratory for PT the same group of five
specimens three times a year. The laboratories were required to test these
specimens for analytes for which they did patient testing and mail their
results to AAB by a date certain, approximately 10 days after receiving
the samples. Testing samples for Garden City, among others, included cholesterol,
HDL cholesterol, triglycerides, glucose, thyroid-stimulating hormone (TSH),
total thyroxine (T4), triiodothyronine (T3), and free thyroxine (FT4). By letter dated January 4, 1999, Dennis W. Jay, Ph.D.,
Technical Director of the Proficiency Testing Service of the AAB sent
the Michigan Department of Consumer and Industry Services (MDCIS) some
proficiency testing results for a group of Detroit area laboratories that
he deemed to be suspect. HCFA Ex. 1 at 3-8. Specifically, the cover letter
suggested that the same PT results were being submitted by several laboratories.
There where five facilities that submitted identical PT results for cholesterol,
HDL cholesterol, triglycerides, and glucose with respect to five different
specimens.(2) The five facilities were:
(1) Oakland Medical Group (ID 23D036505); 2) John Dunn, M.D. (23D0367266);
3) Mark Hertzberg (23D0671668); 4) Rochester Road Clinic (23D0363051);
and 5) Nazar Sarafa, M.D. (23D0367601). On January14, 1999, AAB notified MDCIS that they had discovered
another four facilities reporting duplicate results and included their
1998 third quarter summaries and attestation sheets.(3)
These four facilities were: (1) Liptawat Family, P.C. (23D0363230); 2)
Lakeland Medical (23D0371925); 3) Ecorse Med Center (23D06733353); and
4) Stanley Boykansky, M.D. (23D0372207). On March 2, 1999, Ms. Lucy Estes, Laboratory Evaluation
Specialist, MDCIS, performed a complaint survey of Petitioner's facilities.
Based on her review of the testing records she received from Petitioner,
and information from AAB concerning the similarity of PT results between
Petitioner and others in the Detroit area, Ms. Estes found that Petitioner
was not in compliance with the CLIA requirements under 42 C.F.R. � 493.801(b)(1),
Testing Proficiency Samples; 42 C.F.R. � 493.1205(e)(1), and 42 C. F.
R. � 493.1451(b)(4), Technical Supervisor Responsibilities. She completed
and submitted HCFA Form 2567 to her supervisor, Richard J. Benson, along
with the aforementioned documents. See HCFA Ex 3 at 6-10. By letter dated July 9, 1999, HCFA served notice of cancellation,
suspension, and revocation of CLIA certificate of accreditation to Petitioner,
pursuant to MDCIS referral of its case for imposition of enforcement action.
Specifically, it was found that Petitioner was not in compliance with
the following CLIA statutory and regulatory requirements: (1) The laboratory
must not send PT samples or portions of samples to another laboratory
for any analysis which it is certified to perform in its own laboratory.
42 C.F.R. � 493.801(b)(4). (2) The laboratory agrees to treat proficiency
testing samples in the same manner as it treats materials derived from
the human body referred to it for laboratory examinations or other procedures.
42 U.S.C. � 263a(d)(E); 42 C.F.R. � 493.61(b)(1); 42 C.F.R. � 493.801.(b)(1),
(2), (3). Because of the improper referral of laboratory and PT
samples to another laboratory for analysis and other serious deficient
test practices found during the survey, HCFA imposed the principal sanctions
of cancellation of Petitioner's approval to receive Medicare payment for
its laboratory services and revocation of Petitioner's CLIA certificate
of accreditation. HCFA Ex. 3. A final and more complete notice of adverse action was
served on Petitioner by letter dated October 15, 1999. HCFA Ex. 3. The
letter addressed to Petitioner's director, Dr. Nazar N. Sarafa, where
pertinent here, states as follows:
By letter dated August 18, 1999, Petitioner requested a hearing before an administrative law judge. The case was assigned to me for hearing and decision. Petitioner argues that an evidentiary hearing is essential to explore certain factual issues in dispute. I disagree. For the reasons set forth below, I find that summary judgment is appropriate. There are no material issues of fact in dispute that require an evidentiary hearing. Based on the documentary evidence, written declarations, arguments of the parties, and applicable law and regulations, I find that there are no genuine issues of fact in dispute, and HCFA is entitled to judgment as a matter of law. I further find that Petitioner failed to meet the CLIA conditions of PT under 42 C.F.R. Part 493, Subpart H, generally. Specifically, Petitioner did not satisfy the conditions for testing of samples pursuant to 42 C.F.R. �� 493.801 and 493.803 and for laboratory director under 42 C.F.R. � 493.1441. Petitioner also failed to satisfy the standard for test methods under 42 C.F.R. � 493.1205(e)(1). Pursuant to 42 C.F.R. � 493.61, Petitioner failed to satisfy the requirements for a certificate of accreditation. Thus, I order the revocation of Petitioner's certification under the Clinical Laboratory Improvement Act of 1988, 42 U.S.C. � 263a, for a period of one year as proposed by HCFA. I also direct cancellation of approval to receive Medicare payment for services. Summary judgment is appropriate when there is no genuine
issue as to any material fact and the proponent is entitled to judgement
as a matter of law. If the moving party meets this burden, the onus shifts
to the opposing party to establish that a genuine issue does exist. The
opposing party will have shown that genuine issues of fact are present
"if the evidence is such that a reasonable jury could return a verdict
for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 248, 249 (1986). To accomplish this, the opposing party must
go beyond mere allegations, and come forward with actual evidence that
creates a genuine issue of material fact. All reasonable inferences are
to be drawn in the opposing party's favor. Pollock v. American Telephone
& Telegraph Long Lines, 794 F.2d 860, 864 (3rd Cir.
1986). I have considered all the evidence set forth in the papers submitted
and conclude that all inferences drawn from such evidence, casts no doubt
as to the propriety of granting HCFA's motion for summary judgment inasmuch
as there is no issue of material fact to be tried. HCFA's motion is properly
supported by affidavits and documentary evidence. Petitioner has relied
on mere allegations and denials, thus falling short of showing that there
is a genuine issue for hearing. More significantly, the facts upon which
summary judgment rests are facts conceded or not disputed by Petitioner. III. HCFA's Contentions HCFA contends that the documentary evidence from Petitioner's
own records and the PT results submitted to AAB for the three testing
events in 1998 leave no doubt that Oakland's PT results were obtained
either in collaboration with, or referral to, other Michigan laboratories
in violation of 42 U.S.C. � 263a(i)(4), 42 C.F.R. � 493.61 and 42 C.F.R.
Part 493, Subpart H. HCFA also argues that Petitioner failed to test PT
samples with patient regular workload and that it was in violation of
the condition for laboratory director and standard for test methods. HCFA
further argues that summary judgment is appropriate as a matter of law
given the absence of a genuine or material issue of fact and the overwhelming
evidence that Petitioner did not meet the requirements of the statute,
particularly the CLIA conditions for PT and the laboratory director. Accordingly,
HCFA asks that I sustain the revocation of Petitioner's CLIA certificate
for one year and withdrawal of approval to receive Medicare payment for
laboratory services. IV. Petitioner's Contentions In opposition to HCFA's motion for summary judgment, Petitioner
advances the following arguments: (1) there was no intentional referral
of proficiency samples; (2) the laboratory acted in good faith by terminating
the employee who created the problem; (3) the Government has not shown
that the proficiency testing was not performed in the ordinary course
of business; and (4) the statistical analysis offered by HCFA is not statistically
significant.
VI. Findings of Fact and Conclusions of law I hereby make the following findings of fact and conclusions of law: 1. Petitioner is a laboratory located in Garden City,
Michigan, engaging in high complexity testing for routine chemistry and
endocrinology and operating by virtue of a certificate of accreditation
under CLIA. HCFA Ex. 6. 2. Nazar Sarafa, M.D. is Petitioner's laboratory director.
HCFA Ex. 7. 3. Deborah Sabo performed high routine chemistry and endocrinology
and PT for Petitioner and for other laboratories in the Detroit Metro
area. HCFA Exs. 7, 11-13. 4. Some of the laboratories in the Detroit metro area
participating in a PT program operated by AAB are: Garden City Medical
Clinic; Oakland Medical Group; John Dunn, M.D.; Mark Hertzberg, M.D.;
Rochester Rd. Clinic; Liptawat Family, PC; Lakeland Medical; Ecorse Med.
Center; and Stanley Boykansky, M.D. HCFA Ex. 2. 5. AAB mails each laboratory participating in the PT program
the same group of five specimens three times per year. The laboratories
are required to test these specimens for analytes for which they did patient
testing and mail their results to the AAB. 6. Testing samples for Petitioner included cholesterol,
HDL cholesterol, triglycerides, glucose, TSH, T4, T3, FT4. 7. The affidavits and documentary evidence submitted by
HCFA in support of its motion for summary judgment show that Petitioner
reported PT results to the AAB in 1998 that were identical to the results
of eight other Detroit area laboratories for cholesterol, HDL cholesterol,
triglycerides, and glucose with respect to five different specimens. 8. From the multitude of identical results, as well as
Petitioner's own admission, I find that Petitioner engaged in collaboration
and inter-laboratory communications with other Detroit Metro area facilities
in violation of 42 C.F.R. � 493.801(b)(3). 9. Petitioner did not arrive at identical results to that
of eight other laboratories through human error or coincidence but by
manipulation of PT results. 10. The PT scores reported by Petitioner to AAB in the
testing events for 1998 were not obtained through onsite testing of specimens. 11. Petitioner did not treat PT samples in the routine
manner in which it treated patient specimens. 42 C.F.R. � 493.801(b)(1). 12. Petitioner did not successfully participate in a PT
program. 42 C.F.R. � 493.803. 13. Dr. Nazar Sarafa, as laboratory director, was responsible
for Petitioner's overall operation and administration. His responsibilities
included the employment of competent personnel to perform test procedures,
record and report test results promptly, accurately and proficiently,
and assuring compliance with applicable regulations. 14. Petitioner was in violation of the condition for laboratory
director in failing to provide proper overall management and direction
to the facility. 15. Petitioner did not meet the CLIA standards for test
methods pursuant to 42 C.F.R. � 493.1205(e)(1). 16. Petitioner has submitted no affidavits or other documentary
evidence that if taken as true would create a genuine issue of material
fact that would require a hearing. 17. Pursuant to 42 U.S.C. � 263a(f), the Secretary is
directed to ensure that certified clinical laboratories perform tests
that are valid and reliable. 18. A laboratory that is issued a certificate of accreditation
under CLIA must enroll in a PT program and comply with the requirements
of 42 C.F.R. Part 493, Subpart H. 19. The facts on which I base this summary judgment are
either not in dispute or uncontroverted. Thus, summary judgment is appropriate
as a matter of law. 20. HCFA is authorized to revoke Petitioner's CLIA certificate
for at least one year and cancel its approval to receive Medicare payment
for its services. VII. Discussion
Petitioner contends that a finding of intentional referral
is not appropriate inasmuch as HCFA made its finding based on a mere inference
of collaboration. In this respect, it claims that no finding of referral
is possible in the absence of evidence of a physical transfer from one
laboratory to another. HCFA, on the other hand, contends that an inference
of referral may be drawn from Petitioner's submission to AAB of proficiency
testing results that demonstrably were not arrived at through testing
samples on site. I need not determine here, however, whether evidence
of physical transport is essential for a finding of referral in light
of HCFA's own uncontradicted showing that referral did not occur. The documentary evidence submitted by HCFA establishes
that through an investigation conducted by Petitioner it was determined
that an employee of Garden City Medical Clinic, whom also did testing
for various other laboratories in the Detroit Metro area, used the data
from tests done at one of the laboratories for all of her employers' proficiency
examinations. See HCFA Ex. 17 at 2; HCFA Ex. 18 at 11-13. There is no dispute that nine laboratories in the Detroit
Metro area submitted identical or near identical PT results to AAB in
the three testing events for 1998. HCFA Ex. 16, Attachment C. From the
facts of this case, I am unable to determine which of the nine facilities
provided the results that the others followed. The affidavit of Richard
A. Benson, nonetheless, clearly demonstrates that the PT results obtained
by Petitioner were at variance with the results reported to AAB. See
HCFA Ex. 16. See also HCFA Ex. 3 at 7. Thus, Petitioner's
claim that it did not refer PT samples to another laboratory, but rather,
that Ms. Sabo relied on the testing performed at one of the other laboratories
is credible.
Although there is no evidence of referral of PT samples,
the facts, as presented by Petitioner do establish collaboration with
other participating laboratories in the Detroit Metro area. An affidavit
prepared by William E. Robertson, an investigator hired by Petitioner
(HCFA Ex. 18), states that Deborah Sabo worked at approximately 11 laboratories
and had the responsibility of performing PT at each of these. Furthermore,
in a letter addressed to HCFA on July 22, 1999, counsel for Petitioner
stated the following:
This manipulation of PT results by Petitioner's employee
explains the identical and near identical scores produced by at least
nine participating laboratories in the Detroit, Michigan area during the
1998 testing events.(4) Such actions by
Petitioner are plainly collaboration within the meaning of 42 C.F.R. �
493.801(b)(3). Richard J. Benson, Chief, Laboratory Improvement Section,
MDCIS, compiled a spread sheet from the PT testing results reported by
nine laboratories for the three testing events in 1998 in the Detroit
Metro area. See HCFA Ex. 16 at 23-25. Mr. Benson highlighted in
bold the reported scores for those laboratories where Ms. Sabo was entrusted
with the PT. The identical results in the reported analytes is inescapable.
Moreover, the identical results reported by Petitioner and other laboratories
where Ms. Sabo was not the person in charge of proficiency testing further
magnifies the collusion with other participating facilities. These scores
were reported to AAB even where they were known to be at variance from
the results of local testing, and thus, incorrect. Again, the unequivocal
conclusion is that Petitioner engaged in collaboration within the meaning
of 42 C.F.R. � 493.801(b)(3). The affidavit of Dr. Dennis W. Jay (HCFA Ex. 15), lends
additional support for the finding of improper collaboration in light
of the lack of variability in results submitted for triglycerides and
total cholesterol. This was particularly unusual, stated Dr. Jay, because
these assays typically show poor reproducibility from laboratory to laboratory
when manually performed, as opposed to automated testing methods. Based
upon his education and experience, given the imprecision on manual testing
methodology and the range of acceptable results, Dr. Jay expected to see
variations in results on the order of 10-20 percent for cholesterol and
triglycerides. Instead identical values were reported by Petitioner and
eight other Detroit area laboratories. Dr. Jay further opined that the
chances of nine laboratories independently arriving at the same values
by happenstance for all five specimens for even two different tests are
close to nil. See HCFA Ex. 15 at 3-4. Dr. Jay's opinion is based not only on his expertise,
but also on his personal examination and analysis of the data obtained
from Petitioner's own records. Although some of his findings may be laced
with statistical implications, the thrust of his declaration is more associated
with the manner in which certain chemical properties will behave given
specific testing conditions.
Deviation from the standard practice of routine testing,
handling and reporting of PT samples is a violation of the requirements
at 42 C.F.R. � 403.801(b)(1) and (5). Petitioner concedes that its employee
manipulated PT scores to agree with those obtained at another facility,
and the results reported to the PT facility were not the product of testing
performed at Garden City Medical Clinic. Consequently, the results of
PT samples reported to AAB were not obtained through testing performed
with the laboratory's regular patient workload. Petitioner does not deny that Ms. Sabo engaged in improprieties
in the handling and reporting of PT results. It claims, however, that
she acted on her own, without the knowledge of her employer. Additionally,
Petitioner alleges to have taken corrective action by terminating Ms.
Sabo's employment and requesting an independent examination by AAB. This
defense is not acceptable.
A participating laboratory must have a director who provides
overall direction and proper management for a laboratory pursuant to 42
C.F.R. �� 493.1441 and 1445. The evidence of record, and Petitioner's
own admissions, confirm that proficiency samples were not processed using
the laboratory's regular testing procedures. In this regard, it is noted
that the PT results reported to AAB, the PT agency, were not obtained
through onsite testing, following the facility's routine methods. Dr.
Sarafa's failure to ensure that the PT scores reported to AAB were the
result of onsite testing, and not those obtained through testing at other
participating laboratories are a clear indication that he was out of touch
with the everyday operations of his laboratory. It was his ultimate responsibility
to ascertain that proficiency testing and reporting was carried out in
accordance with the requirements set forth at 42 C.F.R. � 493.801. It
is noteworthy that Dr. Sarafa signed attestation sheets for the three
testing events of 1998, documenting that the PT samples were tested in
the same manner as patient specimens, without the necessary corroboration
in order to ascertain that the reported results were consistent with onsite
testing that complied with CLIA requirements. This is a clear violation
of 42 C.F.R. � 493.801(b)(5). It is also the laboratory director's duty to ensure that
stored controls and reagents do not exceed their expiration dates. As
will be more particularly discussed in the following section, a review
of records from 1997 to 1999 by the surveyor on March 3, 1999 revealed
that Petitioner continued to store reagents and control materials beyond
their expiration date. HCFA Ex. at 8. Petitioner did not have a technical supervisor. It was,
therefore, incumbent upon the laboratory director to establish a quality
control program. Dr. Sarafa failed to do this. Such is evident from the
surveyor's finding that the accuracy of testing could not be confirmed
because the control materials were not available for review. See
HCFA Ex. 3 at 9. Petitioner argues that these control materials were present
and could have been shown to the surveyor had she asked for them. It fails
to explain, however, why the surveyor was unable to find them or why assistance
was not made available without the asking. Be that as it may, if the materials
in question were in fact present at the time of the survey, the cooperative
presence of the laboratory director would have made them available for
review. Petitioner's argument at this juncture appears to be concoction
in the aftermath. Needless to say, even without this additional deficiency,
Dr. Sarafa did not meet the condition for laboratory director. The regulations promulgated by the Secretary make the laboratory director responsible for assuring that a laboratory satisfies CLIA requirements. Petitioner's failure to meet those requirements points to the laboratory director's failure to properly discharge his duties. Moreover, Petitioner's laboratory director failed to meet his obligations under the standard at 42 C.F.R. � 493.1445 to such an extent that it constitutes a failure on the part of Petitioner to comply with the condition for laboratory director.
42 C.F.R. � 493.1205(e)(1) requires that solutions, culture
media, control materials, calibration materials and other supplies must
be stored and handled in a manner to ensure that they are not used when
they have exceeded their expiration date, have deteriorated, or are of
substandard quality. Based on a review of 1997 to 1999 records and observations,
the surveyor (Lucy Estes) found that Petitioner continued to store three
controls and reagents that had exceeded their expiration date.
Petitioner contends that the sanctions imposed and proposed
are not appropriate according to the enforcement procedures set forth
in the CLIA regulations. It points out that the deficiencies alleged on
the HCFA 2567 Statement of Deficiencies are not condition level. Consequently,
Petitioner suggests that revocation of its CLIA certificate is not the
proper remedy, but the requirement that it submit a plan of correction
acceptable to HCFA. See HCFA Ex. 17. The uncontroverted facts of this case leave no room for
doubt that Petitioner failed to comply with the conditions of participation
at 42 C.F.R. � 493.61(b), 42 C.F.R. Part 493, Subpart H, and 42 C.F.R.
� 1441. HCFA relied on 42 C.F.R. � 493.61(b) to establish that by not
treating proficiency samples in the same manner as patient samples, Petitioner
could be subject to suspension or revocation of its certificate of accreditation
or other alternative sanctions. By relying on, and reporting to AAB, PT
results that were not obtained through the integration of proficiency
specimens with its regular patient workload, Petitioner was in violation
of the requirement for a certificate of accreditation. Petitioner's failure to satisfy the requirements under
42 C.F.R. � 493.801(b)(1), (3), and (5) is so egregious that it amounts
to a violation of the condition for treatment of PT specimens and the
condition requiring successful participation in an approved PT program
under 42 C.F.R. � 493.803. The failure to meet the condition regarding laboratory
director is of such magnitude that this violation alone would suffice
to support revocation of Petitioner's certificate for one year. Petitioner
does not perceive the enormity of the deficiencies and thus suggests that
a minor remedy, that includes a plan of correction, would be more appropriate.
The thrust of Petitioner's argument is rooted in the lack of evidence
pointing to referral of PT samples. However, even absent a finding that
referral took place, there is a more than ample basis for revocation of
its certificate of accreditation. Thus, HCFA has properly exercised its
authority to impose principal sanctions, and Petitioner has no standing
to claim that imposition of alternative sanctions is the appropriate remedy
in this case. VIII. Conclusion Petitioner failed to comply with more than one laboratory condition of participation under CLIA. The presence of at least one condition level deficiency in Petitioner's operations authorizes HCFA to impose the remedies of suspension and revocation of Petitioner's CLIA certificate for at least one year, and cancel its approval to receive Medicare payment for its services, effective September 11, 1999. I hereby grant HCFA's motion for summary judgment.
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JUDGE | |
Jose A. Anglada Administrative Law Judge
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FOOTNOTES | |
1. The score for a sample in routine chemistry is the score determined under either paragraph (c)(2) or (c)(3) of 42 C.F.R. � 493.931. The score for endocrinology is determined under paragraph (c)(2) or (c)(3) of 42 C.F.R. � 493.933. 2. These results were for the third quarter PT for 1998. 3. HCFA Ex. 2. 4. The identity of the PT scores cannot be explained by a mere unorthodox practice of rounding. This is exemplified by the illustration at HCFA Ex. 3 at 7. | |