Calvin S. Rosenfeld, M.D., P.A., DAB CR5736 (2020)

DECISION

Petitioner, Calvin S. Rosenfeld, M.D., P.A., is a Florida clinical laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a.  It performs moderate complexity hematology tests, including tests for the analyte red blood cells (RBC).1   The Centers for Medicare and Medicaid Services (CMS) determined that the laboratory failed to meet two condition-level requirements for CLIA certification and has imposed sanctions.

Petitioner appeals.

For the reasons set forth below, I find that, until December 20, 2018, Petitioner Rosenfeld violated statutory and regulatory proficiency testing requirements:  42 U.S.C. §§ 263a(d), 263a(f)(3); 42 C.F.R. §§ 493.803(a), 493.851(a), 493.1403.  CMS may therefore impose sanctions.  42 U.S.C. §§ 263a(h), 263a(i)(1); 42 C.F.R. §§ 493.803(b); 493.1804(b)(1)(ii).  However, effective December 20, 2018, Petitioner brought itself back into compliance, so Medicare payments should resume as of that date.  42 C.F.R. § 493.1826(c)(1).

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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 (1988), amending section 353 of the Public Health Service Act, codified at 42 U.S.C. § 263a; see H.R. Rep. No. 100-899 at 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. § 263a(f); 42 C.F.R. part 493.  A condition represents a major division of laboratory services or required environmental protections; each condition is broken down into more detailed standards that laboratories must meet to be compliant with the overall condition.  42 C.F.R. § 493.2; Victor Valley Community Hospital/ Clinical Laboratory and Tomasz Pawlowski, M.D., DAB No. 2340 at 4 (2010); White Lake Family Medicine, P.C., DAB No. 1951 at 2-3 (2004); RNA Laboratories, Inc. and Ter-Zakarian Medical Clinic, DAB No. 1820 at 3 (2002).

A laboratory that holds a CLIA certificate may perform moderate and high complexity tests, but must participate in a proficiency testing program, as outlined in 42 C.F.R. part 493, subpart H.  Part 493 mandates that each laboratory enroll in an approved program that meets the specific criteria set out in subpart I of part 493.  42 C.F.R. § 493.801.  A laboratory performing "nonwaived" testing (which includes the moderate complexity test that Petitioner performed) "must successfully participate" in an approved proficiency testing program for each "specialty, subspecialty, and analyte or test in which [it] is certified under CLIA."  42 C.F.R. § 493.803(a).

Three times a year, the proficiency testing program, in which the laboratory is enrolled, sends to the laboratory samples to be tested; these are referred to as Event 1, Event 2, and Event 3.  Each shipment has five samples for each of the regulated analytes.  CMS Ex. 10 at 2 (Bowers Decl. ¶ 6).  For laboratories certified in the specialty of hematology (as Petitioner was), the following constitute unsatisfactory performance:

• failing to attain a score of at least 80% of acceptable response for each analyte in each testing event.  42 C.F.R. § 493.851(a);
• failing to attain an overall testing event score of at least 80%.  42 C.F.R. § 498.851(b);
• failing to achieve satisfactory performance for the same analyte in two consecutive events or in two out of three consecutive testing events.  42 C.F.R. § 493.851(f);

and

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• failing to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events.  42 C.F.R. § 493.851(g).

The statute gives the Secretary of Health and Human Services broad enforcement authority, which the Secretary has delegated to CMS.  CMS or its designee conducts periodic inspections to determine a laboratory's compliance with CLIA requirements.  42 C.F.R. § 493.1777.  If it determines that a lab does not comply with one or more CLIA conditions, CMS may suspend or revoke its CLIA certificate, and it may impose alternative sanctions (directed plan of correction, state monitoring, civil money penalty).  42 U.S.C. § 263a(h)(2), (i)(1)(C); 42 C.F.R. §§ 493.1804(b)(1)(ii), 493.1806, 493.1807; The Malaria & Rheumatic Disease Research Institute, Inc., DAB No. 2872 at 4 (2018), citing Ward Gen. Practice Clinic, DAB No. 1624 at 2 (1997).

Here, CMS has determined that Petitioner did not two meet condition-level requirements for CLIA certification:  42 C.F.R. § 493.803(a), which requires the lab to participate successfully in a proficiency testing program; and 42 C.F.R. § 493.1403, which sets forth requirements for the lab director for labs performing moderate complexity testing.  CMS Ex. 2.  Based on these findings, CMS has imposed sanctions:  1) it limited, for six months (effective sixty days from October 9, 2018), the lab's CLIA certificate in the specialty of hematology for the analyte red blood cell count (RBC) (principal sanction); 2) it suspended, for six months, the lab's approval to receive Medicare payments for hematology for the analyte, red blood cells (alternative sanction); and 3) it directed a plan of correction.  CMS Ex. 2 at 1-2.

Petitioner appeals.  CMS has moved for summary judgment.  However, an in-person hearing would serve no purpose.  In my initial order, I directed the parties to list all proposed witnesses and to provide each witness's written direct testimony in the form of an affidavit or written declaration.  Acknowledgment and Pre‑hearing Order at 3, 5-6 (¶¶ 3(c)(iv), 7) (September 7, 2018).  I also directed them to indicate, affirmatively, which, if any, witnesses they wished to cross-examine.  Pre-hearing Order at 6 (¶ 8).  CMS listed one witness and provided her written declaration.  CMS Ex. 10.  Petitioner listed no witnesses and did not ask to cross-examine CMS's witness.  A hearing would therefore serve no purpose, and I may decide the case based on the written record, without considering whether the standards for summary judgment are met.  See Pre‑hearing Order at 6 (¶ 9) ("A hearing to cross-examine witnesses will be necessary only if a party files admissible, written direct testimony, and the opposing party asks to cross-examine.").

With its motion and brief (CMS MSJ), CMS submits ten exhibits (CMS Exs. 1-10).  In response, Petitioner submits a letter (P. Response) with two exhibits (P. Exs. 1-2).  In the absence of any objections, I admit CMS Exs. 1-10 and P. Exs. 1-2.

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Issues

On the merits, the sole issue before me is:  Did Petitioner comply with CLIA conditions of certification, specifically 42 C.F.R. § 493.803(a) and 42 C.F.R. § 493.1403?

I have no authority to review which sanction CMS imposed.  42 C.F.R. § 493.1844(c)(4).

Discussion

1. Until December 20, 2018, Petitioner did not comply with two CLIA conditions of certification, 42 C.F.R. §§ 493.803(a) and 493.1403:  1) it did not successfully participate in the testing program in the specialty of hematology for the analyte RBC; and 2) its lab director did not assure that the lab complied with proficiency testing requirements.2

Proficiency testing results.  On September 6, 2017, Anne Bowers, a surveyor for the Florida Agency for Health Care Administration (state agency), reviewed Petitioner's proficiency testing results and found that, for the analyte RBC, the lab had failed three of its five prior testing events (2016-1, 2016-3, 2017-2).  CMS Ex. 4; CMS Ex. 8 at 1, 12‑20; CMS Ex. 10 at 3 (Bowers Decl. ¶ 13).  The lab submitted a plan of correction and remedial test scores, which CMS accepted.  CMS did not then impose sanctions, although it cautioned the laboratory "to maintain compliance with CLIA requirements for successful proficiency testing" and warned that "[a]ny future repeat proficiency testing failures would be basis for immediate sanction action to limit, suspend, or revoke the laboratory's CLIA certificate."  CMS Ex. 8 at 11.

On June 22, 2018, Surveyor Bowers again reviewed Petitioner's recent proficiency testing scores for the analyte, red blood cell count in the specialty of hematology, adding the first event of 2018.  The lab's scores were:

• 2016 Event 1 – 0% (unacceptable)  (CMS Ex. 3 at 8; CMS Ex. 7)
• 2016 Event 2 – 100% (acceptable)  (CMS Ex. 7 at 1) 
• 2016 Event 3 – 60%  (unacceptable)  (CMS Ex. 3 at 8; CMS Ex. 7 at 1)
• 2017 Event 1 – 100% (acceptable)  (CMS Ex. 4)
• 2017 Event 2 – 60% (unacceptable)  (CMS Ex. 3 at 8; CMS Ex. 6 at 6)

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• 2017 Event 3 – 100% (acceptable)  (CMS Ex. 3 at 12; CMS Ex. 4)
• 2018 Event 1 – 60% (unacceptable)  (CMS Ex. 3 at 8, 13; CMS Ex. 4; CMS Ex. 5 at 3)

See CMS Ex. 10 at 3, 4 (Bowers Decl. ¶¶ 16, 18, 19).

Thus, the laboratory did not achieve satisfactory performance (80%) in two consecutive testing events, as required under the standard for hematology.  42 C.F.R. § 493.851(f).  It therefore did not participate successfully in its proficiency testing program, as required by section 493.803(a).  This is a condition-level deficiency.

Laboratory director.  A laboratory must also have a qualified director (see 42 C.F.R. § 493.1405), who provides overall management and direction, in accordance with 42 C.F.R. § 493.1407.  42 C.F.R. § 493.1403.  Among the director's specific responsibilities, he/she must ensure that the laboratory is enrolled in an approved proficiency testing program, that the samples are tested as required, and that the laboratory establishes and maintains acceptable levels of analytical performance for each test system. 42 C.F.R. § 493.1407(e)(4), (6).  Because the laboratory director did not fulfill these responsibilities, the laboratory was out of compliance with the condition governing laboratory director.

Petitioner's defense.  For its part, Petitioner does not challenge any of this, including CMS's conclusion that the lab didn't meet two conditions of certification.  Instead, it blames its poor performance on old equipment and asserts that the new equipment "will obviate any future proficiency inadequacies."  P. Response.  Petitioner submits a rental agreement, signed August 27 and September 11, 2018, for new equipment (P. Ex. 1), along with testing results for the two remaining testing events of 2018.  P. Ex. 2.  They show acceptable performances on all samples for the analyte RBC:

• 2018 Event 2 (100%) (acceptable)  P. Ex. 2 at 2
• 2018 Event 3 (100%) (acceptable)  P. Ex. 2 at 2, 4

P. Ex. 2 at 4.   CMS has not challenged this evidence.

Thus, the undisputed evidence establishes that the lab returned to compliance on December 20, 2018, the date it achieved satisfactory performance in two consecutive testing events.  It therefore corrected the deficiency cited under section 493.803(a) (successful participation in proficiency testing).  Because the deficiency cited under section 493.1403 (lab director) derived from the lab's proficiency testing failures, it also achieved compliance with that requirement as of December 20, 2018.

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Conclusion

The undisputed evidence establishes that, until December 20, 2018, Petitioner Rosenfeld violated statutory and regulatory proficiency testing requirements:  42 U.S.C. § 263a(d), (f)(3); 42 C.F.R. §§ 493.803(a), 493.851(a), 493.1403.  CMS may therefore impose sanctions.  42 U.S.C. § 263a(h), (i)(1); 42 C.F.R. §§ 493.803(b), 493.1804(b)(1)(ii).  As of December 20, 2018, it returned to compliance.

1. An analyte is a substance whose chemical constituents are being identified and measured.
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2. My findings of fact and conclusions of law are set forth, in bold and italics, as captions in the discussion sections of this decision.
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