SUBJECT:

Preferred Family Clinic,

Petitioner,

Centers for Medicare & Medicaid Services

DECISION

Preferred Family Clinic (Petitioner) is a Michigan-based clinical laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a et seq. Petitioner appeals the decision of the Centers for Medicare & Medicaid Services (CMS) ⁽¹⁾ to impose sanctions against it. Those sanctions include revoking Petitioner's CLIA certificate for at least one year and cancelling its approval to receive Medicare payments. For the reasons discussed below, I sustain CMS's determinations.

I. Background

In a letter dated March 3, 2000, the Commission on Office Laboratory Accreditation (COLA) advised CMS that it had denied Petitioner accreditation because Petitioner had knowingly compared the results of proficiency tests (PT) with another laboratory. CMS exhibit (CMS Ex.) 3. In response, CMS directed the Michigan Department of Consumer and Industry Services (State Agency) to conduct an unannounced investigation survey at Petitioner's facility to determine whether the improper PT referral had occurred and to identify the laboratory with which Petitioner purportedly compared results. CMS Ex. 10.

On April 17, 2000, the State Agency conducted its survey and reported its findings to CMS. CMS Ex. 2, at 7 et seq. Based on the survey results, CMS found COLA's allegations credible; improper referral, collaboration, and non-integration of PT samples occurred during 1998 and 1999 testing events. In a notice dated October 27, 2000, CMS advised Petitioner that it was out of compliance with two condition-level CLIA requirements: 42 C.F.R. § 493.801 (Enrollment and Testing of Samples) and 42 C.F.R. § 493.1441 (Laboratory Director). Specifically: 1) Petitioner did not routinely integrate PT samples into its regular workload, in violation of the standard at 42 C.F.R. § 493.801(b)(1); 2) Petitioner referred some PT samples to another laboratory for analysis, in violation of the standard at 42 C.F.R. § 493.801(b)(4); 3) Petitioner collaborated in the administration of the PT samples for specific test events of 1998 and 1999, a violation of the standard at 42 C.F.R. § 493.801(b)(3); 4) Petitioner did not maintain a copy of all PT documentation for 1998 and 1999 PT results, as required by the standard at 42 C.F.R. § 493.801(b)(5); 5) no documentation confirmed that PT was performed after 1998, as required by the standard at 42 C.F.R. § 493.801(b)(5); and 6) Petitioner was not enrolled in a PT program for the first testing event of 1999, in violation of 42 C.F.R. § 493.801. CMS Ex. 2, at 1 - 2.

CMS also determined that Petitioner's laboratory director had not fulfilled his responsibility for assuring that PT samples were tested as required under 42 C.F.R. § 493, subpart H. The laboratory's deficiencies demonstrated that the director had failed to fulfill his responsibility for its overall operation and administration. Thus, CMS found Petitioner out of compliance on the condition-level requirement for laboratory director. 42 C.F.R. § 493.1441. CMS Ex. 2. CMS concluded that Petitioner's noncompliance substantially limited Petitioner's capacity to render accurate and reliable services and to protect the health and safety of Petitioner's laboratory patients. Based on the state survey findings, CMS proposed to revoke Petitioner's CLIA certificate and to cancel its approval to receive Medicare payment for its laboratory services. CMS Ex. 2, at 3.

Petitioner timely requested a hearing. CMS seeks summary affirmance (CMS Br.), which Petitioner opposes (P. Br.). With its motion for summary affirmance, CMS filed 14 exhibits (CMS Exs. 1 - 14). With its brief, Petitioner filed five exhibits (P. Exs. 1 - 5) and a copy of CMS Ex. 8 and a copy of page 1 of CMS Ex. 4. In the absence of objection, I admit CMS Exs. 1 - 14 and P. Exs. 1 - 5 into evidence. I am not marking Petitioner's copies of CMS Ex. 8 and page 1 of CMS Ex. 4 as separate exhibits, as they are already in the record.

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 the revocation of Petitioner's CLIA certificate and the cancellation of Petitioner's approval to receive Medicare payments.

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. Public Law No. 100-578, amending section 353 of the Public Health Service Act, codified at 42 U.S.C. § 263a et seq.; see H.R. Rep. No. 899, 100^th Cong. 2d Sess. 8 (1988), reprinted in 1988 U.S.C.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. § 263(a)(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, Inc., DAB No. 1820, at 3 (2002).

A laboratory that holds a CLIA certificate of accreditation is permitted to perform moderate and high complexity tests and 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 moderate or 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 treat and analyze PT samples in the same manner as patient samples. 42 C.F.R. § 493.801(b); 42 C.F.R. § 493.61(b)(1); 42 U.S.C. § 263a(d)(1)(E). 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 here) conducts validation inspections to determine a laboratory's 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 state monitoring. 42 C.F.R. § 493.1806.

A laboratory is entitled to a hearing before an 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 conditions. The laboratory has the ultimate burden of rebutting, by a preponderance of the evidence, CMS's prima facie case. Emil S. Sitto, M.D., DAB CR935, at 4 (2002), citing Edison Medical Laboratories, Inc., DAB No. 1713 (1999); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd. Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEV), slip op. at 25 (D.N.J. May 13, 1999).

IV. Discussion

I make findings of fact and conclusions of law (Findings) to support my decision. I set forth each finding, below, in bold and italics, as a separately numbered heading.

1. Summary disposition is appropriate where, as here, Petitioner has not demonstrated any dispute regarding 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. 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 Clinic, DAB No. 1763, at 12 (2001), citing 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). A party may not simply state that it disputes allegations of fact in order to avoid the entry of summary disposition; it must describe the asserted facts credibly in order to establish a dispute.

CMS is requesting summary affirmance here as a matter of law because it asserts that no material facts are in dispute. Petitioner argues generally from the undisputed material facts that CMS's evidence does not prove its allegations (P. Br. at 6), but it offers no affidavit, declaration, or other documentary evidence to rebut CMS's case. Instead, the parties look at the same evidence and argue different conclusions. Under these circumstances, summary judgment is appropriate. Sitto, at 4 - 5.

2. During 1998 and 1999, Petitioner violated 42 C.F.R. § 493.801 by colluding with other laboratories in the testing of proficiency samples, and by failing to test the samples in the same manner as it tested patient specimens.

As noted above, clinical laboratories must enroll in a PT program that meets 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. During 1998 and 1999, Petitioner participated in a PT program offered by the American College of Physicians-American Society of Internal Medicine, known as Medical Laboratory Evaluation (MLE). CMS Ex. 5, at 4. MLE mailed samples to its participating laboratories three times per year (each such transmission is known as a testing event). The participating laboratories were required to test those samples and send the results to MLE. See Id. at 2. To determine whether the laboratory had properly analyzed its samples, MLE compared the results it received from all the laboratories that had, using the same equipment and reagent combination, analyzed samples from the same specimen pool. MLE then provided each laboratory with a PT evaluation report which included graded results and details of the laboratory's performance in that testing event. The laboratory could use the report to review its own performance, and make any necessary corrections. The accrediting organization, such as COLA, would also consider the report in evaluating the laboratory's performance. Id.

COLA's June 1999 Inspection

COLA performs a biannual onsite inspection for each laboratory enrolled in its accreditation program, and on June 29, 1999, COLA inspected Petitioner's facility. Id. at 3. The inspector found significant irregularities in MLE test result forms. For two of the three 1998 testing events - testing event B-1 (form MLE 98-1) and B-2 (form MLE 98-2) - the forms reflected test results for Endocrinology: Triodothyronine Uptake (T3UP). Yet, Petitioner did not perform that test. Id. at 4. ⁽²⁾

The inspector found other irregularities. Petitioner's form MLE 98-1 contained an attestation statement, signed by Marilyn Nichols, MT, and another individual whose signature is illegible, certifying that the analyses of the PT specimens were performed, as closely as possible, in the same manner as regular patient samples. Id. at 4 - 5, 19. On the form is a preprinted identification number that MLE assigned to Petitioner, MLE ID 008180. Id. at 5, 19. The laboratory is required to enter manually the last four digits of that number in boxes at the top of each page of the MLE test result form. On two of the pages it appeared that Petitioner's MLE number was written over the top of other numbers. Id. at 5, 20, 21.

In the identification number box of Petitioner's form MLE 98-2, the digits "8045" are discernable. But this was not Petitioner's number. Id. at 5, 25, 28. COLA and MLE had assigned this number to another laboratory - Lab A - also enrolled in their accreditation program. The inspector visited Lab A on August 18, 1999. Marilyn Nichols, MT, was one of Lab A's employees. On August 11, 1999, the inspector visited a third laboratory enrolled in COLA - Lab B. Its PT records contained Lab A's MLE number, rather than the number it had been assigned. Marilyn Nichols was also employed at Lab B. Id. at 5. ⁽³⁾

COLA staff then reviewed PT reports for 1998 testing events for the three laboratories. Id. at 5 - 6, 29. They found that the three laboratories all performed tests in Endocrinology (four separate tests) and Routine Chemistry (four separate tests) after each laboratory received samples from the same MLE specimen pool. The three laboratories, in total, performed 106 analyses in common. Each laboratory reported to MLE exactly the same PT results for all eight tests performed by each of them in 1998 (see Id. at 29). Id. at 6 - 7, 29. According to the unchallenged opinion of CMS's expert, Ms. Betty Kathryn Connolly, BS, MT, three laboratories independently obtaining identical results on eight different tests strongly suggests collusion. Even if a laboratory ran the same test multiple times, the results would be expected to vary at least slightly ⁽⁴⁾. Id. at 7; accord RNA Laboratories, at 6; Sitto, at 8.

Petitioner had no records or procedures showing how it prepared, processed, and reported PT samples. It had no testing logs or instrument tapes to substantiate that it performed the 1998 tests on the premises. It had no copies of the attestation forms sent to MLE for the second and third events of 1998. Id. at 7 - 8. The laboratory had no records or other evidence showing that it tested T3UP, even though its MLE test result forms for testing events 98-1 and 98-2 contained results for this test. Id. at 4, 8, 23, 27. In reviewing findings from the COLA survey, Ms. Connolly reasonably inferred that the test result forms did not reflect testing actually performed by Petitioner, but reflected testing performed by some other laboratory. Id. at 8.

Following the June 1999 inspection, COLA's staff accreditation (STAT) team ⁽⁵⁾ reviewed the inspector's findings and determined that Petitioner had either compared PT results or submitted PT samples to another laboratory prior to the PT program end-date for reporting results, a violation of COLA standards. The team recommended denial of accreditation. COLA notified Petitioner by letter dated October 19, 1999, that it had been denied accreditation and could seek reconsideration. Petitioner instead notified COLA that it no longer was performing moderate or high complexity testing and asked to withdraw from the program - an action permitted by COLA policy - which COLA allowed "with notice." When a laboratory withdraws "with notice," COLA informs CMS that the laboratory has withdrawn subject to denial proceedings and apprises CMS as to the reason for the denial and withdrawal. Id. at 8 - 9.

The State Agency Surveys

COLA notified CMS that it had initially denied Petitioner's accreditation because Petitioner had either knowingly compared PT results or had referred its PT samples to another laboratory. In response, CMS asked the State Agency to conduct an unannounced CLIA complaint investigation survey. The State Agency conducted its survey on April 17, 2000. The state surveyor reviewed Petitioner's documentation (CMS Ex. 11) and concluded that Petitioner had not kept PT records required to substantiate that it performed its 1998 and 1999 testing on the premises in the same manner as patient testing. CMS Ex. 6, at 3 - 4.

Moreover, although sparse, the records Petitioner produced suggest multiple testing of the PT samples, but only single tests for the patient specimens. A work sheet for MLE 98-1, for example, shows multiple test results for several of the tests (chol, HDL, Trig, and LDL) of samples 1, 2, 3, 4, and 5. CMS Ex. 11, at 4. Records of the tests on patient specimens, on the other hand, contain only one result per specimen. See, e.g., Id. at 13.

The records suggest other significant irregularities. For the 1998-2 testing event, the test score indicated on the work sheet (Id. at 3) was not the score recorded on the MLE 98-2 (Id. at 2):

The documents confirm that Marilyn Nichols was responsible for Petitioner's PT in 1998 and 1999. Id. at 1; CMS Ex. 4, at 3, 9; CMS Exs. 7, 8. The State Agency was aware that Ms. Nichols also performed PT for Oakland Family Practice (Oakland) (which COLA referred to as Lab A), and on May 10, 2000, conducted an unannounced survey of the Oakland lab. There, the surveyor found a chart prepared by COLA's STAT team comparing test results from Petitioner, Oakland, and Preferred Family Medicine (which COLA referred to as Lab B). CMS Ex. 9; CMS Ex. 6, at 5. Inasmuch as COLA's data showed identical results on eight different tests, State Agency staff undertook their own comparison of the three laboratories' PT results.

Mr. Richard J. Benson, CLS, MT, is the State Agency's Chief of Hospital, Laboratory & Medical Facilities Section, Bureau of Health Systems. He compared the 1998 and 1999 MLE PT data for Petitioner and Oakland. CMS Ex. 12; CMS Ex. 6, at 6. Both laboratories tested for the following seven analytes: Total Cholesterol, Triglycerides, Thyroid Stimulating Hormone (TSH), Thyroxine (T4), Free T4, High Density Lipoprotein (HDL) and Triiodothyronine (T3). The laboratory was given five samples to test for each of the analytes, so each laboratory recorded 35 test results for each testing event. In 1998, there were 3 testing events so each lab performed a total of 105 tests that year. ⁽⁷⁾ Petitioner and Oakland reported identical results for all 105 tests.

Petitioner participated in only one testing event in 1999, and reported results identical to Oakland's in 33 of the 35 tests performed. CMS Ex. 6, at 6 - 7.

Both laboratories used manual techniques to measure and compare the samples. Reagents and samples were measured and introduced into test tubes by hand, incubated, then individually analyzed. In an unchallenged opinion, Mr. Benson explained that such manual procedures are difficult to reproduce exactly; therefore, results are rarely duplicated exactly, even when one person performs the same test twice on the same sample in the same laboratory. For this reason, laboratory monitoring agencies accept a broad range of "correct results" for manual tests for Cholesterol, HDL Cholesterol, Triglycerides, T4, and TSH. According to Mr. Benson,

Exact reproduction of results of all five samples of an analyte series would be astounding. Exact reproduction of results for seven analytes (with five samples per analyte) would defy belief . . . Based on my professional training and experience such identity of reported results is absurd unless explained by some sort of collaborative process between the two laboratories.

CMS Ex. 6, at 7. Accord, RNA Laboratories, at 6; Sitto, at 7 - 8.

Petitioner does not challenge the factual evidence, but asserts, incorrectly, that CMS has the burden of proof and has failed to satisfy that burden because its evidence creates only "strong inferences" that its PT samples were tested elsewhere. P. Br. at 6 ⁽⁸⁾. As noted above, CMS's burden is to establish a prima facie case of the laboratory's noncompliance. The laboratory has the ultimate burden of rebutting, by a preponderance of evidence, the prima facie case of noncompliance. CMS's showing of identical test results certainly satisfies its prima facie burden. Indeed, in RNA Laboratories, Judge 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. RNA Laboratories, Inc., DAB CR829, at 7 - 8 (2001). 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, DAB No. 1820, at 7.

Other uncontested evidence bolsters CMS's case. First, that Ms. Nichols performed the testing for all three laboratories certainly creates a better-than-ordinary opportunity for collusion. Petitioner concedes that she engaged in a "waive of misconducts (sic)" while in Petitioner's employ and that she "may have compared proficiency testing results" with Oakland or other laboratories. CMS Ex. 7. Second, Petitioner has not explained how test results for T3UP appeared on Petitioner's MLE test result forms, even though Petitioner does not test for T3UP. Third, Petitioner has offered no satisfactory explanation as to why its MLE identification number was entered over the last four digits of Oakland's MLE identification number on Petitioner's 1998-1 MLE test form. And, finally, Petitioner failed to produce records establishing that it integrated the PT samples with its regular patient samples, and actually tested the PT samples in its own laboratory. In the absence of any other credible explanation, I can reasonably infer that Petitioner and Oakland colluded to manipulate their PT results.

Nor does the unfortunate death in February 2000, of Petitioner's then laboratory director relieve Petitioner of its responsibility to demonstrate compliance with CLIA requirements. I note first that Petitioner's serious irregularities were pointed out as early as the June 1999 COLA inspection. I find it incredible that Petitioner's owner and operator, Mr. Ndubisi G. Igwe, would not then have been aware of the allegations against its testing practices. Moreover, the regulations specifically require that laboratories maintain careful PT records. Petitioner's inability to respond to CMS's findings must be attributed to its own sloppy record-keeping practices, not the death of its medical director.

3. During 1998 and 1999, Petitioner did not comply with the requirements of 42 C.F.R. § 493.1441 (laboratory director) .

42 C.F.R. § 493.1441 requires that a laboratory have a qualified laboratory director who provides overall management and direction to the laboratory 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 the regulations. Among the director's specific responsibilities, he/she must ensure that the laboratory is enrolled in an approved PT program, that the PT samples are tested as required, and that PT results are reviewed in order to identify problems. See Oakland Medical Group, P.C., DAB No. 1755, at 21 - 22 (2000) ("Adopting procedures to assure that required documentation is produced, maintained, and checked for accuracy is certainly within the responsibilities of a laboratory director.").

Inasmuch as the laboratory director did not insure that PT samples were tested in accordance with regulatory requirements, Petitioner did not comply with the regulation governing laboratory director. Given the egregiousness of its conduct, these are condition-level deficiencies.

Petitioner argues that neither the laboratory owner nor the director knew about the irregularities in testing the PT samples, attributing the problems to a rogue employee. Under the statute and the regulations, the laboratory's owners and operators are responsible for the actions of "all individuals it authorizes to perform chemistry testing at its facility on its behalf." Oakland Medical Group, P.C., at 10, 20 - 22; Stanley Boykansky, M.D., DAB No. 1756, at 17 (2000). 42 C.F.R. § 493.1445 establishes the director's responsibility for the overall operation and administration of the laboratory, including the employment of competent testing personnel. The regulation specifically provides that delegation of those duties does not relieve the director of responsibility. 42 C.F.R. § 493.1445(b). See also Melvin C. Murphy, M.D., DAB CR590, at 7 (1999); 42 C.F.R. § § 493.2, 493.801, 493.1840(b).

4. CMS is authorized to revoke Petitioner's CLIA certificate and cancel its approval to receive Medicare payments.

Petitioner contends that it should be allowed to participate in and be reimbursed by the Medicare program because it withdrew from the COLA accreditation program, is limiting its testing to waived testing, and has a new laboratory director. Petitioner cites no authority for its contention and I must reject it. Having determined that Petitioner failed to comply with conditions of participation, CMS is authorized to impose principal sanctions, including revocation of the laboratory's CLIA certificate. 42 C.F.R. § 493.1806(a),(b). CMS may also cancel the laboratory's approval to receive Medicare payment for its services. 42 C.F.R. § 493.1807. Where - as here - a laboratory intentionally refers its PT samples to another laboratory, the regulations require that its CLIA certificate be revoked for at least one year. 42 C.F.R. § 493.801(b)(4); 42 U.S.C. § 263(a)(i)(4). Petitioner may not avoid a sanction for deficiencies that affect the overall safety of its testing program by withdrawing its certification for some of its testing. See Ward General Practice Clinic, DAB CR451 (1996), aff'd. DAB No. 1624 (1997).

V. Conclusion

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

Carolyn Cozad Hughes

Administrative Law Judge

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. Petitioner performed the following tests: Endocrinology: Triodothyronine (T3), Thyroxine (T4), Free Thyroxine (FT4), and Thyroid Stimulating Hormone (TSH); Routine Chemistry: Cholesterol (Chol), Low Density Lipoprotein (LDL), High

Density Lipoprotein (HDL), Triglycerides (TRIG). Id.

3. Lab A's MLE identification number is 8045 and Lab B's identification number is 9015. Id. at 6. Lab A is Oakland Family Practice and Lab B is Preferred Family Medicine. CMS Ex. 6, at 4 - 5.

4. Ms Connolly is the Surveys Division Assistant Manager at COLA. In that capacity, she supervises COLA's onsite inspection process, and trains COLA surveyors and team leaders. She has 17 years experience as a clinical laboratory technologist and laboratory manager. CMS Ex. 5, at 1.

5. The STAT team is a technical review team, composed of COLA's senior staff, which reviews laboratory inspection findings for issues affecting accreditation.

6. The work sheet's T3 figures, at roughly one hundred times greater, seem totally out of line with the expected (and reported) range for Triodothyronine testing. Neither party ventured any explanation for the extreme discrepency.

7. COLA's count of the total number of test results differs from Mr. Benson's because the scope of their comparisons differed slightly. As CMS explains, Mr. Benson compared only two, rather than three laboratory results, and did not compare results for all of the analytes tested. CMS Br. at 3 - 4, n.2.

8. I note also that the statute does not require evidence of actual physical transport of samples. The intentional referral language of 42 C.F.R. § 493.801(b)(4) applies to constructive referral as well as physical transfer. Sitto, at 9 - 10.