UNEVX, Inc. d/b/a R.E.D. Laboratories, DAB CR5723 (2020)

DECISION

The Centers for Medicare & Medicaid Services (CMS) proposed to revoke the certificate of Petitioner, UNEVX, Inc., d/b/a R.E.D. Laboratories, to operate as a clinical laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  I conclude there was a basis to revoke Petitioner’s CLIA certificate due to its failure to have a technical supervisor, which placed Petitioner out of compliance with a condition required for CLIA certification and Medicare coverage pursuant to 42 C.F.R. § 493.1447.

For the reasons discussed below, I find there is no dispute as to any material fact, and CMS is entitled to judgment as a matter of law.  Petitioner’s CLIA certificate is revoked effective the date of this decision.  42 C.F.R. § 493.1840(e)(1).  Further, Petitioner’s owners and operators are prohibited from owning, operating, or directing a laboratory subject to CLIA for two years due to the revocation of its CLIA certificate.  42 U.S.C. § 263a(i)(3).  Finally, I have no authority to review CMS’s exercise of its discretion to impose a per-day civil monetary penalty (CMP) of $6,033.  42 C.F.R. §§ 493.1844(b), (c); 493.1806(b), (c).

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I.  Background

CLIA establishes requirements for all laboratories that perform clinical diagnostic tests on human specimens and provides for federal certification of such laboratories.1   The purpose of CLIA is to “to strengthen federal oversight of clinical laboratories to ensure that [laboratory] tests are accurate and reliable.”2  H.R. Rep. No. 100-899 at 8 (1988), reprinted in 1988 U.S.C.C.A.N. 3828-29.  CMS certification of a laboratory under CLIA is dependent upon whether the laboratory meets the conditions for certification set out in the statute and regulations.  42 U.S.C. § 263a(d), (f); 42 C.F.R. pt. 493.  Pursuant to CLIA, the Secretary of the Department of Health and Human Services (Secretary) has broad enforcement authority, including the ability to suspend, limit, or revoke the certificate of a laboratory that is out of compliance with one or more requirements for certification.  42 U.S.C. § 263a(h), (i).

The Secretary has exercised the authority granted by 42 U.S.C. § 263a(f) and issued regulations implementing CLIA that are codified at 42 C.F.R. pt. 493.  The regulations specify conditions and standards for certification that a laboratory must meet and maintain in order to be certified to test human specimens and participate in the Medicare program.  The regulations confer broad authority on CMS to ensure that laboratories perform as Congress intended, including the authority to inspect and sanction laboratories that fail to comply with the regulatory requirements.  CMS has the delegated authority to suspend, limit, or revoke the CLIA certificate of a laboratory that is out of compliance with one or more CLIA conditions, and CMS may also impose alternative sanctions, such as a directed plan of correction, monitoring by the state, and a CMP.  42 C.F.R. §§ 493.1806‑.1844.  Cancellation of Medicare payments is also authorized as a principal sanction when condition-level deficiencies are found (42 C.F.R. §§ 493.1807(a) and 493.1842(a)(2)) and required when CMS suspends or revokes a laboratory’s certificate (42 C.F.R. § 493.1842(a)(1)).  Under the regulations, a single condition-level deficiency is an adequate basis for principal and alternative sanctions.  42 C.F.R. § 493.1806(a); see White Lake Family Med., P.C., DAB No. 1951 at 2 (2004). 

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Subject to an exception not applicable to this case, CLIA provides that a laboratory’s certificate may be suspended, revoked, or limited only after reasonable notice and opportunity for hearing to “the owner or operator of the laboratory . . . .”  42 U.S.C. § 263a(i)(1).  The Secretary’s regulations provide that a laboratory or prospective laboratory dissatisfied with an initial determination listed in 42 C.F.R. § 493.1844(b) is entitled to a hearing before an administrative law judge (ALJ).  42 C.F.R. § 493.1844(a), (f).  The hearing procedures of 42 C.F.R. pt. 498, subpt. D are applicable pursuant to 42 C.F.R. § 493.1844(a)(2).  The “suspension, limitation or revocation of the laboratory’s CLIA certificate . . . because of noncompliance” is an initial determination that triggers a right to a hearing before an ALJ.  42 C.F.R. § 493.1844(b)(1).  The imposition of an alternative sanction, such as a CMP, is also an initial determination that triggers a right to request a hearing.  42 C.F.R. § 493.1844(b)(3), (f)(1).  A CMS determination to impose a particular alternative sanction, including the amount of a per-day or per-violation CMP and that deficiencies pose immediate jeopardy, is not subject to ALJ review.  42 C.F.R. § 493.1844(c)(4), (6) and (7).  Generally, when a hearing is requested, revocation of a CLIA certificate is not effective until after a hearing decision is issued by the ALJ.  42 C.F.R. §§ 493.1840(d)(1), (e), 493.1844(d)(2).  This decision is final unless a party requests and receives review by the Departmental Appeals Board (DAB).  42 C.F.R. § 493.1844(d)(4).  

The allocation of the burden of proof in an appeal of CMS’s sanctions is discussed in Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. Dep’t of Health & Human Servs., No. 98-3789 (GEB), slip. Op. (D.N.J. 1999); Edison Med. Labs., Inc.,DAB No. 1713 (1999) (applying Hillman burden of proof to CLIA appeals), aff’d, Edison Med. Lab., Inc. v. Health Care Financing Admin., 250 F.3d 735 (Table) (3rd Cir. 2001).  CMS has the burden of presenting sufficient evidence to prove a prima facie case of noncompliance with one or more CLIA conditions.  The petitioner then has the ultimate burden of showing by a preponderance of the evidence (i.e., more likely than not) that it was in compliance with CLIA conditions.  Regarding the imposition of sanctions, the issue to be resolved by the ALJ is not whether CMS properly exercised discretion in imposing either principal or alternative sanctions, but rather, whether a basis existed for the imposition of sanctions under governing statutory and regulatory authorities based upon the evidence before the ALJ, i.e.,the ALJ resolves these issues de novo.  Rustom Ali, Jahan Ferdous, & Scottsdale Med. Lab., DAB No. 2016 at 21 (2006) (citing Emerald Oaks, DAB No. 1800 at 16 (2001)).

Petitioner is a clinical laboratory located in Reno, Nevada.  CMS Ex. 2 at 1.  Petitioner had a CLIA certificate to perform non-waived, high complexity testing.  See CMS Ex. 2 at 1.  Surveyors from the Nevada Division of Public and Behavioral Health (state agency) and CMS conducted a recertification survey of Petitioner’s facility that was completed on March 14, 2018.  CMS Exs. 2, 4.  The state agency determined that Petitioner was out of compliance with five conditions required for CLIA certification and Medicare coverage of its services:  42 C.F.R. §§ 493.1230 (general laboratory systems, Tag D5200),

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493.1250 (analytic systems, Tag D5400), 493.1290 (post-analytic systems, Tag D5800), 493.1441 (laboratory director, Tag D6076), and 493.1447 (technical supervisor, Tag D6108).  CMS Ex. 1 at 1; see CMS Ex. 2.  The state agency instructed Petitioner to submit a credible allegation of compliance and acceptable evidence of correction for the cited deficiencies.  CMS Ex. 1 at 2-3.  Petitioner submitted a plan of correction, signed by its laboratory director, dated April 2, 2018, in which it alleged that it would correct all of the cited deficiencies on or before April 30, 2018.  CMS Ex. 2.  In a letter dated April 6, 2018, the state agency found Petitioner’s allegation of compliance not credible and evidence of correction unacceptable and gave Petitioner another opportunity to submit a credible allegation of compliance with acceptable evidence of correction.  CMS Ex. 3.  Petitioner submitted another plan of correction on April 16, 2018, that the state agency again rejected on April 20, 2018.  CMS Exs. 4, 5.

In a letter dated June 19, 2018, CMS notified Petitioner that it concurred with the state agency, including the determination that Petitioner’s deficiencies posed immediate jeopardy, and proposed principal and alternative sanctions against Petitioner.  CMS Ex. 6 at 1-2.  After Petitioner submitted several responses to the notice of proposed sanctions (CMS Exs. 7-9), CMS issued a revised notice of proposed sanctions and again afforded Petitioner an opportunity to “submit in writing any evidence or information as to why the sanctions . . . should not be imposed.”  CMS Ex. 10 at 5 (emphasis omitted).3  

On August 28, 2018, CMS issued a notice informing Petitioner that it would impose several principal and alternative sanctions, to include the principal sanction of revocation of its CLIA certificate4 and the alternative sanction of a per-day CMP of $6,033, effective September 12, 2018, and continuing until either CMS verified correction of all cited deficiencies or Petitioner’s laboratory certificate was revoked.5  CMS Ex. 12 at 2.

Petitioner, through counsel, timely requested a hearing before an ALJ on October 25, 2018.  See 42 U.S.C. § 263a(i); 42 C.F.R. § 493.1844(f)(1).  Judge Bill Thomas issued an Acknowledgment and Pre-Hearing Order (Pre-Hearing Order) directing the parties to file

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their respective pre-hearing exchanges.6   Judge Thomas also granted CMS’s unopposed motion to stay briefing on four deficiencies pending a ruling on the instant motion for summary judgment (CMS Motion).  CMS also filed 17 proposed exhibits (CMS Exs. 1-17).7  Petitioner filed a response to CMS’s motion for summary judgment (P. Response).  CMS filed a reply that was accompanied by a motion for leave to file a reply; Petitioner did not file an opposition to that motion, and therefore, I accept CMS’s reply.

II.  Issues

The issues are:

1. Whether CMS is entitled to summary judgment because undisputed evidence supports CMS’s citation of the condition-level deficiency that Petitioner failed to have a technical supervisor, as required by 42 C.F.R. § 493.1447;
2. Whether CMS had a legitimate basis to revoke Petitioner’s CLIA certificate; and
3. Whether Petitioner is entitled to a hearing to challenge the imposition of a CMP.

III. Discussion8

 A. Summary judgment is appropriate because material facts are not in dispute.

Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law.  Senior Rehab. & Skilled Nursing Ctr.,DAB No. 2300 at 3 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs.,405 F. App’x 820 (5th Cir. 2010); see Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).  The moving party must show that there are no genuine disputes of material fact requiring an evidentiary hearing and that it is entitled to judgment as a matter of law.  Anderson,477 U.S. at 248.  If the moving party meets its initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial.’”  Matsushita Elec.

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Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (emphasis omitted).  “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact -- a fact that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab., DAB No. 2300 at 3.  In determining whether there are genuine issues of material fact for hearing, an ALJ must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor.  Id.

It is well established that an ALJ is empowered to decide a case on a motion for summary judgment, without an evidentiary hearing.  Shah v. Azar, 920 F.3d 987, 996 n.25 (5th Cir. 2019) (citing Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010)); see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 449 (7th Cir. 2010) (“All it means for a decision to be based on a grant of summary judgment is that there are no issues that would benefit from being resolved in an evidentiary hearing.”) (emphasis added); Crestview Parke Care Ctr., 373 F.3d 743, 748-50 (6th Cir. 2004) (explaining that [t]he statute authorizing the imposition of penalties requires a hearing ‘on the record,’ and that the use of summary judgment is “valid” and “provides an alternative to in-person, oral hearings.”); see, e.g., Liberty Lab., Inc., DAB No. 2562 at 5 (2014) (upholding summary judgment in a CLIA appeal).

The material facts establishing Petitioner’s noncompliance with 42 C.F.R. § 493.1447 are not disputed.  Although Petitioner generally disputes the sanctions imposed, it has not, at any point, challenged the determination that it was not compliant with the requirement that it have a technical supervisor.  There is no genuine dispute as to any material fact that requires a hearing, and summary judgment in CMS’s favor is warranted.

B. Petitioner has not submitted evidence to refute undisputed material facts presented by CMS that it was not in compliance with 42 C.F.R. § 493.1447 when it did not have a technical supervisor at the time of the March 2018 survey.

For a laboratory to hold a CLIA certificate to perform testing on human specimens, it must comply with the conditions of CLIA.  42 C.F.R. § 493.1.  Laboratories that perform “high complexity” testing must obtain a CLIA certificate for high complexity testing and meet the requirements 42 C.F.R. pt. 493, subpt. M, among others.  42 C.F.R. § 493.25(a)-(b); see 42 C.F.R. § 493.17(a).  One of the condition-level requirements for a laboratory that performs high complexity testing is that the laboratory “must have a technical

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supervisor who meets the qualification requirements of § 493.14499 . . .  and provides technical supervision in accordance with § 493.1451.”10   42 C.F.R. § 493.1447.

CMS has submitted prima facie evidence that Petitioner did not comply with the condition-level requirement that it have a technical supervisor.  Specifically, the March 14, 2018 statement of deficiencies stated the following:

This CONDITION is not met as evidenced by:  Based on interview with the laboratory manager and the laboratory director, the position of technical supervisor was not filled from 6/09/17 to 3/14/18.

Findings include:
Interview with the laboratory manager during the on-site survey on 3/12/18 revealed that the technical supervisor position was not filled from 6/09/17 when his Nevada State General Supervisor certificate expired on 6/09/17.  The laboratory director learned of this vacancy from the laboratory manager during the on-site survey on 3/12/18.

CMS Ex. 2 at 42.  Petitioner’s April 2, 2018 plan of correction provided the following one-sentence statement regarding this condition-level deficiency:  “The laboratory has replaced the technical supervisor.”  CMS Ex. 2 at 42.  Petitioner reported that it had completed the corrective action on March 14, 2018.  CMS Ex. 2 at 41. 

After the state agency informed Petitioner that it had not provided a credible allegation of compliance and acceptable evidence of correction (CMS Ex. 3), Petitioner submitted a second plan of correction, dated April 16, 2018, in which it stated the following:

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The laboratory has replaced the technical supervisor.  The laboratory has corrected the issue of the laboratory technical supervisor and a new technical supervisor has been put in place.  The new technical supervisor is reviewing the work of the previous technical supervisor for completeness and acceptance.[11 ]

The laboratory director will review the licensure of the laboratory personnel during visitation and record approval in the director visitation log.  This will prevent the loss of certified personnel and stated deficiency from recurring.

This process is currently being performed and the laboratory has placed all affected testing on hold until investigations and corrective actions, including corrected reports can be issued, reviewed, and resolved.[12 ]

CMS Ex. 4 at 43-44. 

In several responses to a June 19, 2018 letter informing Petitioner of proposed sanctions based on its condition-level noncompliance with, inter alia, 42 C.F.R. § 493.1447, Petitioner again did not allege compliance with section 493.1447 at the time of the survey.  CMS Exs. 7-9; see CMS Ex. 6 at 2-4.  In fact, Petitioner explained that it “sincerely wishes to come into compliance with the requirements that apply to it and cooperate with the appropriate regulatory agencies in so doing.”  CMS Ex. 9 at 2.  Petitioner offered that it “would welcome the opportunity to be assisted in returning to full compliance.”  CMS Ex. 9 at 2. 

In its motion for summary judgment, CMS argued that it is an undisputed fact that “[a]t the time of the March 14 survey, Petitioner had no Technical Supervisor.”13   CMS Motion at 7.  CMS further stated that it was an undisputed material fact that “[b]y the time of the March 14 survey, Petitioner had not had a Technical Supervisor for

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approximately eight months.”  CMS Motion at 7.  CMS summarized its argument in support of summary judgment, stating:

As there is no question that Petitioner failed to have a Technical Supervisor; that failure to have a Technical Supervisor is a condition-level violation; and that CMS may impose the full range of sanctions based on condition-level non-compliance, CMS respectfully submits that summary judgment is proper here.

CMS Motion at 3.

In a cursory response to CMS’s motion for summary judgment, Petitioner did not dispute any of the undisputed facts presented by CMS in its motion for summary judgment.  In fact, Petitioner limited its arguments to CMS’s imposition of the principal sanction of revocation.  P. Response at 2 (arguing that a hearing is necessary to determine “whether or not the sanction of revocation of its CLIA certificate was supported by the facts in this case”).  Although Petitioner recognized that it cannot challenge the amount of a CMP in this forum, it nonetheless contended that “the amount of CMPs that would be levied against it . . . are excessive in that they were originally based on multiple condition-level violations and not just the one condition-level violation that is the basis for the Motion.”).  P. Response at 2-3.

It is undisputed that Petitioner conducted non-waived, high complexity testing.  CMS Motion at 7; P. Motion; see CMS Ex. 1 at 1 (identifying deficiencies for “[l]aboratories performing high complexity testing”).  It is also undisputed that Petitioner did not have a technical supervisor from June 2017 through March 14, 2018.  CMS Motion at 7; P. Motion; see CMS Ex. 2 at 41-42.  Petitioner has not offered any argument, much less evidence, to refute the factual determination that it did not have a technical supervisor, as required by 42 C.F.R. § 493.1447.  Therefore, the undisputed evidence supports CMS’s citation of a condition-level deficiency pursuant to 42 C.F.R. § 493.1447 for Petitioner’s failure to have a technical supervisor.

C. Because Petitioner was not compliant with a condition-level requirement at the time of the March 2018 survey, CMS had a legitimate basis to revoke Petitioner’s CLIA certificate.

As previously stated, if a laboratory is out of compliance with even a single CLIA condition, CMS may revoke the laboratory’s CLIA certificate.  42 C.F.R. §§ 493.1806(a), (b); 493.1814(a)(2).  Specifically, CMS may revoke a laboratory’s CLIA certificate if the laboratory has any condition-level deficiencies “at the time of the survey.”  HRT Lab., Inc., DAB No. 2118 at 10 (2007); Rustom Ali, Jahan Ferdous, & Scottsdale Med. Lab., DAB No. 2016 at 8-9 (“Even if [post-survey corrective action] met the regulatory standard, however, it is irrelevant since the salient question here is whether [the

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laboratory] had the requisite record system at the time of the survey.”).  Because Petitioner was noncompliant with a CLIA condition at the time of the March 2018 survey, CMS was authorized, based on this condition-level deficiency alone, to revoke its CLIA certificate.  42 C.F.R. §§ 493.1806(a), (b), 493.1814(a)(2); see also HRT Lab., Inc., DAB No. 2118 at 10.  Therefore, CMS had a legitimate basis to revoke Petitioner’s CLIA certificate.

D. Petitioner’s CLIA certificate is revoked effective the date of this decision granting CMS’s motion for summary judgment.

CMS must notify a laboratory if it takes action to revoke the laboratory’s CLIA certificate, and the notice must inform the laboratory of the effective date of the revocation.  42 C.F.R. § 493.1844(g)(2)(i).  Pursuant to 42 C.F.R. § 493.1844(h)(2) the effective date of the revocation is the date given in the CMS notice, which must be “at least 15 days after the date of the notice” if the laboratory’s deficiencies do not pose immediate jeopardy.  However, pursuant to 42 C.F.R. § 493.1840(e)(1), CMS does not actually revoke a CLIA certificate until after an “ALJ hearing” upholds the revocation.  After an ALJ decision, CMS may decide to revoke a CLIA certificate even if CMS did not previously suspend or limit the CLIA certificate.  42 C.F.R. § 493.1840(e)(1).  Pursuant to 42 C.F.R. § 493.1844(d)(2), absent a determination of immediate jeopardy, “suspension, limitation, or revocation of a CLIA certificate is not effective until after a hearing decision by an ALJ is issued.”  Accordingly, the effective date of the revocation of Petitioner’s CLIA certificate is the date of this decision.14  

E. The amount of the CMP imposed by CMS is not an initial determination that is subject to review by an ALJ, therefore Petitioner is not entitled to a hearing to challenge it.

CMS’s August 28, 2018 notice imposing sanctions informed Petitioner that a per-day CMP of $6,033 would be imposed.  CMS Ex. 12 at 3.  Petitioner correctly recognizes that it cannot challenge the CMP in this forum but has expressed disagreement with the CMP in an apparent effort to preserve this issue for appeal.  P. Response at 2-3.  Petitioner argues that the per-day CMP is “excessive,” in that it was based on multiple condition-level deficiencies, whereas CMS’s motion for summary judgment is supported by only one condition-level deficiency.  P. Response at 3.  CMS, in response, argued that it is

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authorized to impose the full range of CMPs for each violation.  CMS Reply at 2, citing 42 U.S.C. § 263a(h)(2).

Pursuant to 42 C.F.R. § 493.1844(c)(4), the determination as to which alternative sanction to impose, to include the amount of the CMP and whether the CMP is per instance or per day, is “not [an] initial determination[] and therefore [is] not subject to appeal.”  Likewise, “[t]he amount of the civil monetary penalty assessed per day or for each violation of Federal requirements” is not an initial determination that is subject to appeal.  42 C.F.R. § 493.1844(c)(7); see, e.g., Kensington Diagnostics LLC, DAB No. 2992 at 12 (2020) (DAB’s explanation that it “has no authority to overturn or modify a legally valid agency action (such as the imposition of a CMP)” and that it “cannot entertain . . . argument[s] that the penalty amount imposed by CMS in this case (which was within the authorized range) is excessive or unduly burdensome.”).

The per-day CMP of $6,033 falls within the authorized CMP range of $101 to $6,033 that was in effect at that time.  42 C.F.R. § 493.1834(d)(2)(ii); 42 C.F.R. § 102.3 (Oct. 1, 2017).  I am not authorized to reduce a CMP that is within the range of permissible CMPs because the imposition of a CMP is not an initial determination that is subject to ALJ review.  42 C.F.R. § 493.1844(c)(4), (7).

V.  Conclusion

Because CMS has presented undisputed evidence of the condition-level deficiency that Petitioner failed to have a technical supervisor at the time of the survey, CMS had a legitimate basis to revoke its CLIA certificate.

1. Pub. L. No. 100-578, § 2, 102 Stat. 2903, 2903-15 (1988) (amending sec. 353 of the Public Health Service Act, Pub. L. No. 78-410, 58 Stat. 682 (1944) (as added by the Clinical Laboratory Improvement Act of 1967, Pub. L. No. 90-174, § 5, 81 Stat. 533, 536-39 (1967))) (codified at 42 U.S.C. § 263a).
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2. The Secretary has explained that CLIA’s enforcement mechanisms are intended to  “protect all individuals served by laboratories against substandard testing of specimens,” “[t]o safeguard the general public against health and safety hazards that might result from laboratory activities,” and “[t]o motivate laboratories to comply with CLIA requirements so that they can provide accurate and reliable test results.”  42 C.F.R. § 493.1804(a).
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3. In its July 31, 2018 notice revising the proposed sanctions, CMS removed the finding of immediate jeopardy and reduced the per-day CMP.  CMS Ex. 10 at 3-4.
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4. The letter explained that Petitioner’s revocation would become effective in 60 days, unless Petitioner timely requested a hearing.  CMS Ex. 12 at 3.  
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5. CMS also imposed the alternative sanction of a directed portion of a plan of correction, and the principal sanction of cancellation of Petitioner’s approval to receive payments from Medicare for services performed on or after October 27, 2018.  CMS Ex. 12 at 4.
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6. The Civil Remedies Division transferred this case to me on March 8, 2019.
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7. CMS also filed written declarations of both surveyors in support of its motion for summary judgment which it did not label as exhibits.  Because Petitioner did not dispute any of the material facts outlined in CMS’s motion for summary judgment, I do not further address these declarations or rely on them in granting summary judgment.
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8. Findings of fact and conclusions of law are in bold and italics.
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9. Technical supervisor qualifications are enumerated in 42 C.F.R. § 493.1449.  As relevant here, a technical supervisor “must possess a current license issued by the State in which the laboratory is located, if such licensing is required.”  42 C.F.R. § 493.1449(a).
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10. “The technical supervisor is responsible for the technical and scientific oversight of the laboratory.”  42 C.F.R. § 493.1451.  The numerous responsibilities of a technical supervisor are enumerated in 42 C.F.R. § 493.1451(b).  Although not dispositive of the issues before me, I recognize CMS’s allegation that “[a]t the time Petitioner was found to have no Technical Supervisor, staff from CMS and the State Survey Agency also observed that the laboratory’s validation studies of laboratory-developed tests were missing required sections, that the laboratory had failed to properly evaluate and respond to repeated poor Proficiency Testing results, and that the laboratory could not even locate many patient test results.”  CMS Motion at 14.
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11. Petitioner reported that it had taken this corrective action on March 14, 2018.  CMS Ex. 4 at 43.
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12. Petitioner reported that it had completed this corrective action on April 16, 2018.  CMS Ex. 4 at 43-44.
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13. CMS also argued that it is an undisputed material fact that Petitioner conducts high complexity testing.  CMS Motion at 7; see 42 C.F.R. § 493.1447 (applicability of condition-level requirement of having a technical supervisor to laboratories that perform high complexity testing).  Petitioner did not dispute this factual allegation.
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14. I note that CLIA provides that “[n]o person who has owned or operated a laboratory which has had its certificate revoked may, within 2 years of the revocation of the certificate, own or operate a laboratory for which a certificate has been issued under this section.”  42 U.S.C. § 263a(i)(3).
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