CASE | DECISION | JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

Emil S. Sitto, M.D., & Associates, PLLC,

Petitioner,

DATE: July 29, 2002
                                          
             - v -

 

Centers for Medicare & Medicaid Services

 

Docket No.C-01-064
Decision No. CR935
DECISION
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DECISION

Emil S. Sitto, M.D., & Associates, PLLC (Petitioner), is a Michigan-based, physician-owned clinical laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a et seq. In this action, Petitioner appeals the Centers for Medicare & Medicaid Services' (CMS) (1) decision to impose sanctions against it. Those sanctions include suspending Petitioner's CLIA certificate, canceling its approval to receive Medicare payment for its services, and revoking its CLIA certificate for at least one year. For the reasons discussed below, I sustain CMS's determination.

I. Background

In November 1999, the American Association of Bioanalysts Proficiency Testing Service (AAB) notified the Michigan Department of Consumer and Industry Services (State Agency) that Petitioner and another Detroit area laboratory, the Dearborn Family Clinic (Dearborn), had submitted duplicate proficiency testing (PT) results. (2) CMS Ex. 2. In response, the State Agency asked CMS for authorization to conduct an unannounced complaint survey to determine whether improper PT had occurred. CMS Ex. 6. CMS authorized the survey, and on February 8, 2000, the State Agency conducted its onsite survey. CMS Exs. 7, 8.

Based on the survey findings and its comparative analysis of the PT results submitted by Petitioner and Dearborn, the State Agency concluded that Petitioner was not in compliance with CLIA requirements, including the condition-level requirement set forth at 42 C.F.R. § 493.801, which covers PT. CMS Exs. 9, 10. It submitted its findings to CMS, with the recommendation that Petitioner's CLIA certificate be revoked for one year. CMS Ex. 15. CMS agreed, and, by letter dated September 1, 2000, advised Petitioner that it was not in compliance with CLIA requirements because improper referral, collaboration, and non-integration occurred during the first, second, and third PT events of 1999. (3) Specifically, the letter advised, the laboratory was out of compliance with 42 C.F.R. §§ 493.801 (proficiency testing), 493.1441 (laboratory director), and 493.1447 (laboratory technical supervisor). The letter also cited statutory and regulatory "Requirements for Certificate," 42 U.S.C. § 263a(d)(1)(E), 42 C.F.R. § 493.61(b)(1), and 42 C.F.R. § 493.801(b)(1)(2)(3), under which the laboratory agrees to treat PT samples in the same manner as materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business. The letter advised that because of the laboratory's failure to meet CLIA conditions, and because of its referral of PT samples to another laboratory for analysis, CMS would suspend Petitioner's CLIA certificate, effective September 24, 2000, cancel its approval to receive Medicare payments for its services, and revoke its CLIA certificate for at least one year. CMS Ex. 19.

Petitioner timely requested a hearing, and the case was assigned to me. CMS has moved for summary disposition, which Petitioner opposes. CMS has filed 29 exhibits, marked as CMS Exs. 1 - 29, plus two declarations with attachments (Jay Declaration and Benson Declaration). In addition to its Response to CMS's Motion for Summary Affirmance

(P. Br.), Petitioner has filed seven exhibits marked P. Exs. 1 - 7. CMS filed a reply brief. In the absence of objection, I admit CMS Exs. 1 - 29, CMS's Declarations, and P. Exs. 1 - 7.

II. Issue

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, including canceling Petitioner's approval to receive Medicare payments and revoking Petitioner's CLIA certificate.

III. Statutory and Regulatory Background

In order to ensure the accuracy and reliability of laboratory tests, and thus the health and safety of those tested, CLIA creates a federal certification process for laboratories that perform clinical diagnostic tests on human specimens. Pub. L. No. 100-578, amending § 353 of the Public Health Service Act, codified at 42 U.S.C. § 263a et seq.;

See H.R. Rep. No. 899, 100th Cong., 2d Sess. 8 (1988), reprinted in 1988 U.S.C.A.N. 3828, 3829. To be certified, a laboratory must meet the conditions of certification set out in the statute and regulations. 42 U.S.C. § 263a(f)(1)(E); 42 C.F.R. § 493.1 et seq. The statute gives the Secretary of Health and Human Services (Secretary) broad enforcement authority, including the authority to suspend, limit, or revoke the certificate of a laboratory that is out of compliance with one or more conditions. Each condition represents a major division of laboratory services or required environmental protections. Standards are specific components of the conditions. RNA Laboratories, DAB No. 1820, at 3 (2002).

Laboratories holding CLIA certificates must participate in the PT program outlined in 42 C.F.R. Part 493, Subpart H. Under its provisions, each laboratory must enroll in an approved PT program that meets specific criteria set out at Subpart I of Part 493. 42 C.F.R. § 493.801. A laboratory performing high complexity testing "must successfully participate" in an approved PT program for each "specialty, subspecialty, and analyte or test in which it is certified under CLIA." 42 C.F.R. § 493.803(a).

A laboratory must analyze PT samples in the same manner as patient samples. 42 C.F.R. § 493.801(b). The PT samples must be integrated with the laboratory's regular patient workload and the tests must be performed by the same 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. 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).

A laboratory may not 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). It 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).

CMS or its designee (such as the State Agency) conducts validation inspections to determine compliance with CLIA requirements. 42 C.F.R. § 493.1780(a). A laboratory's failure to comply with even a single condition in an area of testing offered by that laboratory may be grounds for suspension or revocation of its CLIA certificate. RNA Laboratories, at 3; Ward General Practice Clinic, DAB No. 1624, at 2 (1997). CMS may 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. § 493.1806.

A laboratory is entitled to a hearing before an administrative law judge (ALJ) to contest the imposition of CLIA remedies. The CLIA regulations incorporate by reference the hearing procedures and the request for review provisions in 42 C.F.R. Part 498, Subparts D and E. 42 C.F.R. § 493.1844(A)(2) and (3). 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 condition. 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, aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEV), slip op. At 25 (D.N.J. May 13, 1999) (1997).

IV. Discussion

1. Summary judgment is appropriate where, as here, Petitioner has not demonstrated any dispute over genuine issues of material fact.

Summary disposition is appropriate where there are no disputed issues of material fact and where the only questions that must be decided involve either questions of law or the application of the law to the undisputed facts. Edison Medical Laboratories, Inc., at 19. A party opposing summary disposition 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 (1997) (in-person hearing required where non-movant shows there are material facts in dispute that require testimony). The party may not simply state that it disputes the allegations of fact in order to avoid the entry of summary judgment; it must describe the asserted facts credibly in order to establish a dispute.

CMS argues that it is entitled to judgment as a matter of law because no material facts are in dispute. Although Petitioner alludes generally to the "testimony of the laboratory technician who actually performed the tests," it provides no declarations from any laboratory employees to challenge CMS's evidence, nor offers-of-proof suggesting what that testimony might be. See Oakland Medical Group, P.C., DAB No. 1755 at 9 (2000) (Summary judgment deemed appropriate where Petitioner did not supply documents or affidavits to support its defense). Indeed, Petitioner does not specifically challenge the factual underpinnings of CMS's case, but argues that CMS's evidence (the Jay and Benson Declarations and the Mills letter (CMS Ex. 14)) "does not support the conclusion" that the proficiency testing samples were not integrated into regular patient testing and that patient samples were not tested the same number of times as PT samples. Petitioner Brief (P. Br.) at 2. Petitioner asserts that "it is not altogether unreasonable to determine from [the Mills letter, CMS Ex. 14] that Ms. Mills was indeed properly performing PT at any laboratory at which she worked," (4) and, "the reasonable assumption," based on the worksheets, "is that the proficiency testing and patient sampling were done in the same manner." P. Br. at 4. The parties thus look at the same evidence and argue different conclusions. Under those circumstances, summary judgment is appropriate.

2. During 1999, Petitioner colluded with another laboratory in the testing of proficiency samples in violation of 42 CFR § 493.801.

As noted above, clinical laboratories must enroll in PT programs that meet defined criteria. 42 C.F.R. § 493.801. Each participating laboratory must test its samples independently, as if they were patient specimens, and must report the results of its tests to an approved testing service. In 1999, Petitioner and Dearborn participated in the AAB's PT program. CMS Exs. 3 - 6, 27 - 29. AAB mailed samples to participating laboratories three times per year, and the laboratories were required to test the samples for analytes for which they did patient testing. Both Petitioner and Dearborn tested for cholesterol, triglycerides, thyroid stimulating hormone (TSH), and free thyroxine (FT4). CMS Exs. 3 - 5, 27 - 29. They were required to test five samples for each analyte. Id. For the three 1999 PT events (March, June, and October), Petitioner and Dearborn reported identical scores for all five samples of four analytes. CMS Ex. 6. The undisputed evidence thus establishes that the two laboratories submitted identical results for 60 out of 60 tests (4 analytes tested 5 times each, on 3 occasions).

During the time of the three 1999 PT events, Emil S. Sitto, M.D., was the laboratory director, Robin L. Mills was the technical supervisor, and Pattye Korbal was employed by Petitioner to perform additional testing. CMS Exs. 1, 3 - 5. Robin Mills was also employed at Dearborn as a technical supervisor (high complexity). The same person was thus responsible for performing or supervising high complexity routine chemistry and endocrinology testing for both laboratories. CMS Exs. 3 - 5, 22, 25, 27 - 29.

Both laboratories used manual techniques to measure and compare the samples. Reagents and samples were diluted, measured, and introduced into test tubes by hand, incubated for periods timed by the individual performing the test, and individually analyzed. According to the unchallenged opinions of CMS's experts, the likelihood of two laboratories using these techniques arriving at the same value for a proficiency test result is very low because of the variables involved in the testing processes. In fact, even if one person twice performed the same test on the same sample in the same laboratory with the same equipment, the test results would not be duplicated. Benson Declaration at 4 - 5. According to Dr. Dennis W. Jay, Ph.D., Technical Director of the AAB Proficiency Testing Service, if the same technician repeated the test, one "would expect to see variation on the order of 10-20%." Jay Declaration, at 3. (5)

Petitioner's worksheets more than bear this out. For example, for the first testing event (March 1999), the worksheets show that Petitioner tested each sample twice, and, with one exception, obtained two different test results for each sample:

Test Results
Sample 1 cholesterol

HDL

triglycerides

152 and 150

26 and 28

166 and 178

Sample 2 cholesterol

HDL

triglycerides

144 and 141

34 and 34

121 and 122

Sample 3 cholesterol

HDL

triglycerides

150 and 154

44 and 28

118 and 116

Sample 4 cholesterol

HDL

triglycerides

197 and 208

30 and 32

143 and 132

Sample 5 cholesterol

HDL

triglycerides

185 and 191

40 and 50

132 and 133


CMS Ex. 11, at 1. (6)

Yet, Petitioner and Dearborn reported identical scores for all five samples of four analytes. CMS's experts, Dennis W. Jay, Ph.D., and Richard J. Benson, CLS, MT, Chief, Laboratory Improvement Section, Bureau of Health Systems, of the State Agency, are well-versed in the areas of clinical laboratory testing and PT, and the Departmental Appeals Board has repeatedly recognized Dr. Jay's expertise. See RNA Laboratories, at 7; Oakland at 14-15; Boykansky, at 10. (7) I find these experts to be well-qualified and their opinions to be persuasive. Their conclusions were based on their training and experience in their respective fields and on the evidence that pertained to the specific proficiency tests at issue in this case. According to Dr. Jay, the chances of two laboratories independently arriving at the same values by happenstance for all five specimens for two tests (triglycerides and total cholesterol) "are close to nil."

The complete identity of Petitioner's reported results for four analytes, fifteen specimens each, with every result reported by another laboratory in the same geographic area leads to the inescapable conclusion that the results that were reported to AAB were arrived at through referral, collaboration, or both.

Jay Declaration, at 3. Mr. Benson came to the same "inescapable" conclusion - that the results reported to AAB "were arrived at through some sort of collaborative process." Benson Declaration, at 4.

In RNA Laboratories, ALJ Kessel characterized as "powerful circumstantial proof that Petitioners engaged in prohibited communications," evidence that for one testing event, the petitioner and another laboratory reported identical results for the nine analytes in five samples provided by AAB. RNA Laboratories, at 6. An appellate panel of the Board agreed, ruling "that the logical inference to be drawn from the evidence [of identical results] was that Petitioners had collaborated in obtaining or reporting the results." RNA Laboratories at 8. I agree, and, based on this evidence, I conclude that CMS has met its initial burden of establishing a prima facie case that Petitioner and Dearborn colluded.

Other uncontested evidence bolsters CMS's case. That Ms. Mills was the technical supervisor for both laboratories, certainly creates a better-than-ordinary opportunity for collusion. She signed the reports submitted to AAB, containing the alleged PT results. CMS Exs. 3 - 5. Nor does she deny her improper conduct. In a letter dated February 17, 2000, she concedes that, as a consultant for the Sitto and Dearborn laboratories, she "used improper procedures for the proficiency results." CMS Ex. 14.

Further, Petitioner compounded its violation by not even reporting to AAB many of the PT scores it actually obtained, but instead submitting an average of its two scores. In explaining that she "used improper procedures," Ms. Mills admits to "using an average." CMS Ex. 14. The written record supports her statement. For example, the chart below compares the PT results shown in Ms. Mills' March 1999 worksheets (CMS Ex. 11) with the scores submitted to AAB. Only occasionally does the submitted score coincide with any of the test results. By examining the scores recorded in the Dearborn laboratory log (CMS Ex. 26), one can see the pattern of "averaging" the scores.

Test Results Submitted to AAB Dearborn Log
Sample 1 cholesterol

HDL

triglycerides

TSH (8)

152 and 150

26 and 28

166 and 178

3.54 and 3.7

147

24

166

3.7

144

22

145

3.4

Sample 2 cholesterol

HDL

triglycerides

TSH

144 and 141

34 and 34

121 and 122

2.6 and 3.1

132

31

121

3.2

126

27

99

3.2

Sample 3 cholesterol

HDL

triglycerides

TSH

150 and 154

44 and 28

118 and 116

2.2 and 2.1

143

39

110

2.8

143

34

92

3.4

Sample 4 cholesterol

HDL

triglycerides

TSH

197 and 208

30 and 32

143 and 132

5.4 and 5.6

196

27

141

7.0

187

23

112

6.2

Sample 5 cholesterol

HDL

triglycerides

185 and 191

40 and 50

132 and 133

185

35

117

167

30

94


Compare CMS Ex. 3 with CMS Ex. 11. Absent any other credible explanation, such evidence leads to the inescapable conclusion that Petitioner and Dearborn colluded to manipulate their PT results.

Petitioner points out, accurately, that CMS has not demonstrated the actual physical transport of the PT samples from one laboratory to another. According to Petitioner, the statute is not violated absent the actual physical transport of a sample from one laboratory to another for analysis. P. Br. at 6-8, citing the ALJ decision in Southfield Medical Clinic, DAB CR667 (2000). This argument was fully addressed and rejected in Oakland and Boykansky, where the Board reasonably inferred that the "intentional referral" language of 42 C.F.R. § 493.801(b)(4) applies to constructive referral as well as an actual physical transfer, particularly where the facts render physical transfer unnecessary for the outside analysis to take place.

Limiting the concept of a referral to a physical referral is inconsistent with the underlying purposes of the condition for certification. Adopting the values achieved in another laboratory (either with or without having done the tests in one's own laboratory) clearly undercuts the general concept that the PT sample be tested in the same way as regular patient specimens in the laboratory are tested so that the results truly measure the proficiency of the laboratory in reporting the PT results.

Boykansky, at 14, quoting Oakland, at 17-18.

Thus, the statute does not require evidence of actual physical transport. CMS has met its burden of establishing a prima facie case of collusion, and Petitioner has provided essentially no evidence to refute CMS's compelling case.

3. Petitioner failed to test the PT samples in the same manner as it tested patients' specimens, as required by 42 C.F.R. §§ 493.801 and 493.61.

Petitioner asserts that the worksheets available from Petitioner's laboratory indicate that PT was "done with the regular patient workload and it is impossible to determine whether patient samples were tested the same number of times as proficiency samples." P. Br. at 2. I do not see how the worksheets show that the PT was performed "with the regular patient workload." The PT results are recorded together as a group, and the patient samples are recorded together as a group, separate from the PT results, although sometimes on the same sheet.

Even if I accept that Petitioner performed the PT "with the regular patient workload," that fact does not, by itself, satisfy the regulatory requirement that the samples be tested "in the same manner" as patient specimens. CMS correctly asserts that testing the PT samples twice, but patient specimens only once, violates the "same manner" requirement. Because the regulations require record-keeping, it should not be impossible to determine how many times a sample is tested. 42 C.F.R. § 493.801(b)(5). The worksheets confirm the surveyor finding that Petitioner ran tests of the PT samples more than once. As discussed above, they demonstrate two scores for each. See, e.g., CMS Ex. 11, at 1. I see no evidence that patient samples were tested twice. For each patient sample, the worksheet indicates only one value per type of test. See CMS Exs. 9, at 1-3; 11, at 4.

Petitioner seemingly acknowledges that it tested the PT samples twice, but claims that "many laboratories test proficiency samples twice because they generally provide abnormal results," and that "[l]aboratories almost without exception perform a second test on a patient specimen if the result is abnormal." P. Br. at 2-3. I agree with CMS that the regulations simply do not allow a laboratory to test its PT samples twice if it routinely tests its patient samples only once. 42 C.F.R. § 493.801(b)(2). Moreover, comparing the PT sample results with the patient specimen test results belies Petitioner's claim. For example, a PT sample for cholesterol yielded a finding of 152. The test was re-run, yielding a finding of 150. However, when a patient specimen yielded the same cholesterol level of 152, no evidence suggests that the test was repeated. Compare CMS Ex. 11, at 1(specimen 1) with CMS Ex. 11, at 4 (patient line 5). Similarly, an HDL PT result of 34 was repeated, again yielding 34. CMS Ex. 11, at 1 (sample 2). But patient specimens yielding the same result (34) were not repeated. See CMS Ex. 11, at 4. And when PT specimen 4 yielded an HDL score of 30, the test was repeated, but patient specimen scores of 30 were not repeated. Compare CMS Ex. 11, at 1 with CMS Ex. 11, at 4.

Finally, Petitioner did not even submit to AAB any of the PT scores it actually obtained, but instead relied on an average of its and Dearborn's test results (see above). Thus, each proficiency sample was tested multiple times in two different laboratories, and a composite score was arrived at and submitted. Such procedures could not be considered testing "in the same manner" as the patients' specimen testing in the ordinary course of business.

4. Petitioner's deficiencies were condition-level.

Petitioner argues that, under 42 C.F.R. § 493.801(b)(3) and (4), an inter-laboratory communication, as opposed to the physical transfer of samples, is, at most, a standard-level deficiency not sanctionable by revocation. As discussed above, Petitioner's conduct falls within the "intentional referral" language of 42 C.F.R. § 493.801(b)(4). The statute and regulations therefore mandate revocation of its CLIA certificate for at least one year. 42 U.S.C. § 263(a)(i)(4).

Moreover, as the Board ruled in Oakland and Boykansky, cases involving laboratories which submitted identical PT results, "[i]t is indisputable that a laboratory can be so pervasively noncompliant with standards as to have failed to have complied with the overall condition." Where Petitioner's collusion was "so egregious as to make its participation in proficiency testing meaningless," CMS may appropriately find it out of compliance with conditions of participation, and may impose principal sanctions. Boykansky, at 18 - 19, citing Oakland, at 23.

Here, in an apparent effort to frustrate the purpose of PT, Petitioner colluded with another laboratory, and submitted essentially fabricated PT results, rendering meaningless its participation in the PT program. CMS therefore appropriately determined the Petitioner failed to comply with the condition of participation stated at 42 C.F.R. § 493.801. (9) 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.

5. Petitioner did not comply with the requirements of 42 C.F.R. §§ 493.1441 (laboratory director) or 493.1447 (technical supervisor).

Section 493.1441 of 42 C.F.R. requires that a laboratory have a qualified laboratory director who provides management and direction in accordance with 42 C.F.R. § 493.1445. Section 493.1445 sets out the director's specific responsibilities, which encompass the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures and report test results promptly, accurately, and proficiently, and for assuring compliance with regulations. As part of his specific responsibilities, the director must ensure that the laboratory is enrolled in an approved PT program, and that the testing samples are tested as required, and he must attest to the propriety of the PT. 42 C.F.R. §§ 493.801(b)(5), 493.1445(e)(4). Similarly, the regulations require that a qualified laboratory supervisor provide technical supervision in accordance with 42 C.F.R. § 493.1451. The laboratory supervisor is also responsible for the laboratory's participation in an approved PT program. 42 C.F.R. § 493.1451(b)(3).

Inasmuch as neither the laboratory director nor the supervisor ensured that the PT samples were tested in accordance with regulatory requirements, Petitioner did not comply with the regulations governing laboratory director and supervisor, and, given the egregiousness of its conduct, these are also condition-level deficiencies.

Without specifically denying his responsibility, Petitioner nonetheless notes that no evidence suggests Dr. Sitto "had any knowledge whatsoever" of the alleged irregularities, that he terminated his relationship with the responsible parties when he became aware of the irregularities, and that he subsequently sought to change his laboratory's CLIA certificate to a CLIA certificate of waiver, which does not require PT. P. Br. at 5. It is well-settled that the laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of testing personnel. 42 C.F.R. § 493.1445; Boykansky, at 17; Oakland, at 20-22.

V. Conclusion

For the reasons discussed above, I sustain CMS's determination to suspend Petitioner's CLIA certificate, cancel its approval to receive Medicare payment for its services, and revoke its CLIA certificate for at least one year.

JUDGE
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Carolyn Cozad Hughes

  Administrative Law Judge

FOOTNOTES
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1. The Health Care Financing Administration (HCFA) has been renamed the Centers for Medicare & Medicaid Services. Reference to either name shall apply to both names.

2. CMS also imposed sanctions against Dearborn, which appealed, and a decision in that matter, consistent with my decision here, was recently issued. Dearborn Family Clinic, DAB CR919 (2002).

3. AAB refers to each mailing of samples to laboratories for PT as an "event." Under the AAB program, there are three testing events per year. See Discussion, Infra.

4. As discussed infra, Ms. Mills served as technical supervisor for both Petitioner and Dearborn. In stark contrast to Petitioner's assertion here, Dearborn characterized Ms. Mills as "a renegade laboratory technician, a liar, and dishonest." Dearborn at 13.

5. For this reason, AAB accepts results for each sample from within a broad range. Benson Declaration at 5; Jay Declaration, at 3. The acceptable range is determined by applying a formula that includes averaging the results reported by all participating laboratories that use the same type of equipment and the same methodology. Jay Declaration, at 4. As a result, any collusion among participating laboratories that involves reporting similar or identical values would tend to narrow the overall range of acceptable results for that testing event. Id.

6. Further, as discussed below, these specific test results were not the numbers reported to AAB. See CMS Ex. 3.

7. Dr. Jay is a Board-certified clinical chemist. He has a Ph.D. in clinical chemistry, and completed a two-year postdoctoral fellowship in clinical chemistry at the Medical College of Virginia. He has held his current position since 1998. Prior to that, he was a clinical chemist with the Central Texas Veterans Health Care System, and held various academic posts, including assistant professor with the Department of Pathology and Laboratory Medicine at Texas A&M University College of Medicine. Jay Declaration. Mr. Benson has a B.S. degree, with a major in medical technology, and is a certified medical technologist and certified clinical laboratory scientist. He is a former president of the Michigan Society for Clinical Laboratory Science. Benson Declaration.

8. CMS Ex. 11 at 2

9. I note that Petitioner's collusion also undermines the integrity of the PT process for other laboratories. As Dr. Jay noted, PT is "graded on a 'curve.'" Results from laboratories using the same methodology and equipment are grouped together, and the average value reported determines the range of "correct" responses. Collaboration among laboratories necessarily skews the calculation of the average. So, when multiple laboratories report erroneous results, the integrity of the entire PT program is undermined. Jay Declaration, at 3-4.

CASE | DECISION | JUDGE | FOOTNOTES