SUBJECT:

Open Faith Medical Laboratory,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

The certificate of registration issued to Open Faith Medical Laboratory (the Petitioner) to engage in the testing of human specimens pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) ⁽¹⁾ is revoked. Pursuant to 42 C.F.R. � 493.1844(d)(4)(ii), ⁽²⁾ the revocation of Petitioner's CLIA certificate is effective the date of this decision. By operation of law, the owners and operators of Petitioner are prohibited from owning or operating a CLIA laboratory for two years pursuant to 42 U.S.C. � 263a(i)(3) due to the revocation of Petitioner's CLIA certificate. The two-year prohibition runs from the date of the revocation of the laboratory's certificate pursuant to 42 U.S.C. � 263a(i)(3) - the date of this decision.

I. PROCEDURAL HISTORY

The Centers for Medicare & Medicaid Services (CMS) notified Petitioner and its laboratory director, Richard O'Pere, by letter dated July 19, 2004, that a complaint survey completed on May 17, 2004, by the Illinois Department of Public Health (the state agency) determined that Petitioner was not in compliance with CLIA requirements. CMS advised Petitioner that it was found to be in violation of condition-level requirements established by 42 C.F.R. �� 493.1215 (related to hematology) and 493.1441 (related to qualifications and responsibilities of the laboratory director). CMS further advised Petitioner that it had determined that continuing violation of these CLIA provisions constituted immediate jeopardy, i.e., the violations were likely to cause serious harm to patients served by Petitioner and/or the health of the general public. CMS gave Petitioner until July 27, 2004, to remove the immediate jeopardy or CMS would suspend Petitioner's CLIA certificate and Petitioner would have to cease all testing of human specimens. CMS also warned Petitioner that its authorization to receive Medicare payments for its services would be cancelled. CMS advised Petitioner that it could submit written evidence and information showing why sanctions should not be imposed within ten days. CMS also advised Petitioner that it could request a hearing by an administrative law judge (ALJ). CMS exhibit (Ex.) 14.

CMS sent Petitioner and its laboratory director another notice dated August 17, 2004, in which it advised that a plan of correction submitted by Petitioner dated July 20, 2004, did not remedy the alleged violations. CMS further advised that, based upon Petitioner's July 20 submission, CMS found that Petitioner was also in violation of 42 C.F.R. �� 493.1447 (related to qualification of Petitioner's technical supervisor), 493.1453 (related to qualification of Petitioner's clinical consultant), 493.1459 (related to qualification of Petitioner's general supervisor), and 493.1409 (related to qualification of Petitioner's technical consultant). CMS advised Petitioner that continued operation in violation of CLIA is subject to criminal prosecution and civil action and CMS demanded that Petitioner immediately stop all testing, solicitation and acceptance of human specimens for testing. CMS also advised Petitioner that its CLIA certificate would be revoked effective September 20, 2004, if no request for hearing by an ALJ was timely filed. CMS Ex. 26.

By letter dated September 16, 2004, Robert L. Miller, President of The Chico One Company, requested a hearing on behalf of Open Faith Medical Laboratory. On October 27, 2004, Reba M. O'Pere, Senior Executive Vice-President/Owner of Open Faith Medical Laboratory, filed two documents appointing Richard L. Miller the non-attorney representative of Petitioner, in accordance with 42 C.F.R. � 498.10(b).

This case was assigned to me for hearing and decision on October 5, 2004, and a Notice of Case Assignment and Prehearing Case Development Order (Prehearing Order) was issued at my direction on that date. An amended Prehearing Order was issued on October 12, 2004.

On December 13, 2004, the parties filed a joint status report in which they stated that settlement is unlikely; CMS stated that it intended to move for summary judgment but noted that if the motion is denied a hearing might be required; Petitioner stated that a hearing is not necessary and requested judgment on the parties' briefs. On December 27, 2004, the parties filed their joint statement of issues presented and their joint stipulation of facts (Jt. Stip.). CMS also filed its motion for summary judgment with supporting briefs and exhibits on December 27, 2004. Petitioner filed its response in opposition to the CMS motion for summary judgment on January 4, 2005. CMS filed a prehearing brief on January 10, 2005, as required by the Prehearing Order, but no prehearing brief has been received from Petitioner. CMS filed exhibits 1 through 37. Petitioner has made no objection to my consideration of the CMS exhibits and, because this case may be resolved on summary judgment, all the CMS exhibits are admitted. Petitioner filed exhibits (P. Exs.) 1 through 16. By letter dated January 11, 2005, CMS objected to ten of Petitioner's exhibits on grounds that they were not timely exchanged and CMS allegedly suffered prejudice. I am resolving this case by summary judgment against Petitioner and I am obliged to consider facts in a light most favorable to Petitioner. Thus, I will admit all Petitioner's exhibits as evidence for my consideration. Furthermore, because this case is resolved favorably to CMS, I see no undue prejudice to CMS by virtue of any late filing of exhibits.

On January 4, 2005, I set the case for hearing for February 23 through 25, 2005, in Chicago, Illinois. On January 21, 2005, I stayed all proceedings pending my ruling on the CMS motion for summary judgment.

II. FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. Findings of Fact

The following findings of fact are based on the evidence admitted at hearing and the testimony of the witnesses. Specific citations to the evidence may be found in the discussion if not included here.

1. Petitioner is located in Chicago, Illinois. Jt. Stip. at 1.

2. Petitioner began operations in November 1999 under a CLIA certificate of accreditation issued by COLA, a private non-profit CLIA accreditation organization authorized to accredit laboratories under CLIA. Overview Statement and Opinion, dated December 4, 2004, signed by Petitioner's Representative; Jt. Stip. at 2.

3. Petitioner performed tests of moderate and high complexity. Jt. Stip. at 1.

4. Petitioner is owned by Richard O'Pere and his wife, Reba O'Pere. Jt. Stip. at 1.

5. Richard O'Pere has been acting as laboratory director of Petitioner at all relevant times. Jt. Stip. at 1.

6. Richard O'Pere was conferred a degree entitled "Doctor en Medicina" (Doctor of Medicine) from the Universidad Tecnologica de Santiago-UTESA, Santo Domingo, Dominican Republic. Jt. Stip. at 1.

7. Richard O'Pere does not have a license to practice medicine in the State of Illinois. Jt. Stip. at 1.

8. Prior to November 18, 2003, Petitioner possessed a certificate of accreditation from COLA that permitted Petitioner to operate as a clinical laboratory testing human specimens and receiving reimbursement from Medicare for eligible claims. Jt. Stip. at 2.

9. On November 18, 2003, the COLA Board of Directors Appeals Committee affirmed the Accreditation Committee's decision to deny accreditation to Petitioner. Jt. Stip. at 2; CMS Ex. 2; CMS Ex. 3.

10. On November 20, 2003, COLA reported to CMS that Petitioner was denied accreditation. Jt. Stip. at 2; CMS Ex. 2.

11. After losing its accreditation from COLA, Petitioner operated temporarily under a certificate of registration pending survey by CMS or its agent and issuance of a certificate of compliance. Jt. Stip. at 2.

12. The state agency completed a complaint survey of Petitioner on May 17, 2004, and alleged that Petitioner was not in compliance with condition-level requirements of 42 C.F.R. �� 493.1215, 493.1441. Jt. Stip. at 2; CMS Ex. 1.

13. CMS notified Petitioner by letter dated July 19, 2004, of the findings of the May 17, 2004 survey; that the condition-level violations presented immediate jeopardy to Petitioner's clients and/or the general public; that if jeopardy was not abated and the violations corrected, the sanctions of suspension of Petitioner's CLIA certificate and Medicare payments would be imposed on July 27, 2004. CMS Ex. 14.

14. CMS notified Petitioner by letter dated August 17, 2004, that its plan of correction was rejected; additional condition-level deficiencies were identified and alleged; and that Petitioner's CLIA certificate would be revoked effective September 20, 2004, if no request for hearing was filed. CMS Ex. 26.

15. All plans of correction submitted by Petitioner were rejected by CMS. Jt. Stip. at 2-3.

16. CMS suspended Petitioner's certificate of registration and cancelled approval of Medicare payments to Petitioner effective July 27, 2004. Jt. Stip. at 3.

17. Petitioner requested a hearing before an ALJ by letter from its representative dated September 16, 2004.

B. Conclusions of Law

1. Petitioner's request for hearing was timely and I have jurisdiction.

2. Summary judgment is appropriate.

3. Richard O'Pere does not have the qualifications required by 42 C.F.R. � 1443(b) to be a laboratory director under CLIA.

4. No qualified laboratory director provided overall management and direction of Petitioner during the relevant time, a clear violation of the condition-level requirement of 42 C.F.R. � 493.1441, and that deficiency has not been corrected.

5. There is a basis for the revocation of Petitioner's CLIA certificate.

6. Revocation is effective the date of this decision.

III. ANALYSIS

A. Issues

1. Whether summary judgment is appropriate.

2. Whether one or more condition-level deficiencies existed at Petitioner.

3. Whether there is a basis for the revocation of Petitioners' CLIA certificate.

B. Applicable Law

CLIA establishes requirements for all laboratories that perform clinical diagnostic tests on human specimens and provides for federal certification of such laboratories. Pub. L. No. 100-578, amending � 353 of the Public Health Service Act, codified at 42 U.S.C. �� 263a, 1302, 1395x(e) (1988). The purpose of CLIA is to ensure the accuracy and reliability of laboratory tests, and, hence, the public health of all Americans. See H.R. Rep. No. 100-899, at 8, 18 (1988), reprinted in 1988 U.S.C.C.A.N. 3828, 3839. CLIA grants the Secretary of Health and Human Services (the Secretary) broad enforcement authority, including the ability to suspend, limit, or revoke the CLIA certificate of a laboratory that is out of compliance with one or more requirements for certification. The Secretary has exercised his authority under 42 U.S.C. � 263a(f) and issued regulations implementing CLIA. See 42 C.F.R. Part 493.

The Secretary's regulations delegate to CMS broad authority to ensure that laboratories perform as Congress intended, including authority to inspect and sanction laboratories that fail to comply with the regulatory requirements. 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(f)(1); 42 C.F.R. � 493.1 et seq. Pursuant to the enforcement provisions of the regulations, CMS may impose principal or alternative sanctions when it finds that a laboratory has a "condition-level" deficiency. 42 C.F.R. � 493.1804(b)(2). Principal sanctions are suspension, limitation, or revocation of a CLIA certificate. 42 C.F.R. � 493.1806(b). Alternative sanctions are a directed plan of correction, state on-site monitoring, and a civil money penalty. 42 C.F.R. � 493.1806(c). 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)). Standard-level deficiencies are not an adequate basis for the imposition of a sanction, except when the laboratory fails to correct such deficiencies within 12 months after the last day of inspection. 42 C.F.R. � 493.1816(b).

Each condition-level requirement of the regulations represents a major division of laboratory services to be offered by the laboratory or establishes an important environmental protection for the laboratory. Since each "condition" represents a major division of laboratory services to be offered by the laboratory or an important safety requirement, it has been held that a failure by a laboratory to comply with even a single applicable condition can represent a critical breakdown in one of the major health care delivery or safety systems of the laboratory. Ward General Practice Clinic, DAB No. 1624, at 2 (1997). Therefore, violation of just one condition-level deficiency can be grounds for a principal sanction, including revocation of a laboratory's CLIA certificate. 42 C.F.R. � 493.1804(b); Edison Medical Laboratories, Inc., DAB No. 1713 (1999).

If, on inspection, a laboratory is found to have condition-level deficiencies that pose immediate jeopardy, CMS requires the laboratory to take immediate action to remove the jeopardy and may impose alternative sanctions to assist. If immediate jeopardy is not removed, CMS may suspend or limit and later revoke the laboratory's CLIA certificate. CMS is also delegated authority to bring a civil suit for an injunction against a laboratory in specified circumstances where there is immediate jeopardy. 42 C.F.R. � 493.1812. Condition-level deficiencies that do not constitute immediate jeopardy, and standard-level deficiencies that do not rise to condition-level, are treated differently, and a laboratory is generally accorded 12 months to correct such deficiencies before action is taken to suspend, limit, or revoke the laboratory's CLIA certificate. 42 C.F.R. �� 493.1814 and 493.1816.

CLIA provides at 42 U.S.C. � 263a(i)(1) 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." The implementing 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 ALJ. 42 C.F.R. � 493.1844(a). The hearing procedures found in subpart D of Title 42, Part 498, are incorporated by reference. 42 C.F.R. � 493.1844(a)(2). The "suspension, limitation, or revocation of the laboratory's CLIA certificate . . . because of noncompliance . . ." is the first listed initial determination subject to hearing before an ALJ. 42 C.F.R. � 493.1844(b)(1). The imposition of alternative sanctions is also an initial determination subject to appeal (42 C.F.R. � 493.1844(b)(3)), but the determination as to which alternative sanctions to impose and the amount of the CMP to be imposed are not. 42 C.F.R. �� 493.1844(b)(3) and (c)(4). The general rule is that suspension, limitation, or revocation of a CLIA certificate does not go into effect if appealed, and is not imposed until the ALJ issues a decision, unless CMS declares immediate jeopardy, and then there is no delay in the suspension or limitation of the offending laboratory's CLIA certificate. 42 C.F.R. � 493.1844(d)(2). Section 498.74 of 42 C.F.R. provides that, absent appeals to the DAB or the U.S. District or Circuit Courts, my decision is final.

In addition to sanctions directed against laboratories, CLIA provides the following with respect to the owners and operators of non-compliant laboratories:

No 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).

The implementing regulations do not include any express provision implementing or imposing this two-year prohibition against an offending owner or operator. However, the regulations provide that CMS may suspend, limit, or revoke a laboratory's CLIA certificate if it finds that the owner or operator has -

[w]ithin the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked. (This provision applies only to the owner or operator, not to all of the laboratory's employees.)

42 C.F.R. � 493.1840(a)(8).

CLIA does not include a definition of the term operator. However, the regulations define an "operator" as:

the individual or group of individuals who oversee all facets of the operation of a laboratory and who bear primary responsibility for the safety and reliability of the results of all specimen testing performed in that laboratory. The term includes -

(1) A director of the laboratory if he or she meets the stated criteria . . . .

42 C.F.R. � 493.2. The "stated criteria" for a laboratory director to be considered an operator are those criteria described in the introductory sentence of the above-quoted section, i.e., whether a person oversaw all facets of the operation of the laboratory and bore primary responsibility for the safety and reliability of the results of specimen testing performed in the laboratory. Sentinel Medical Laboratories, Inc., DAB No. 1762, at 13 (2001), aff'd, Teitelbaum v. Health Care Financing Admin., No. 01-70236 (9th Cir. Mar. 15, 2002), reh'g denied, No. 01-70236 (9th Cir. May 22, 2002); Sol Teitelbaum, M.D., DAB No. 1849, at 8 n.7 (2002). It is a condition-level requirement that a CLIA-certified laboratory have a qualified laboratory director who is required to assume oversight and responsibility for the laboratory and the results of its testing. See 42 C.F.R. �� 493.1403, 493.1405, 493.1407, 493.1441, 493.1443, and 493.1445. Thus, the regulation creates a rebuttable presumption that a laboratory director is an operator of the laboratory within the meaning of the regulations and CLIA.

The allocation of the burden of proof in an appeal of CMS's sanctions is set forth in Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB) (D.N.J. May 13, 1999). Edison Medical Laboratories, Inc., DAB No. 1713 (Hillman burden of proof applicable in CLIA appeals). At a hearing, CMS has the burden of coming forward with 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 that it was not out of compliance with the conditions placed at issue by CMS in its prima facie case. 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. Cf. Emerald Oaks, DAB No. 1800 (2001).

C. Discussion

1. Summary judgment is appropriate.

Pursuant to 42 C.F.R. � 498.66, an affected party may waive its right to appear and present evidence at an oral hearing. An affected party's waiver must be in writing. In this case, Petitioner has waived its right to appear and present evidence at an oral hearing and requests that a decision be made on the briefs and documentary evidence. Joint Status Report, December 13, 2004. CMS has indicated that it does not waive oral hearing if its motion for summary judgment is denied. However, because summary judgment is granted, it is not necessary to determine whether CMS has shown or could show good cause to proceed with an oral hearing in the face of Petitioner's waiver. 42 C.F.R. � 498.66(b)(2).

There is a presumption, pursuant to 42 C.F.R. � 493.1844(f), that a Petitioner has a right to a hearing. See Garden City Medical Clinic, DAB No. 1763 (2001), citing 42 U.S.C. � 263a(i)(1) and 42 C.F.R. � 493.1844(a). However, summary judgment is appropriate and no hearing is required where either: there are no disputed issues of material fact and the only questions that must be decided involve application of law to the undisputed facts; or, the moving party must prevail as a matter of law even if all disputed facts are resolved in favor of the party against whom the motion is made. In order to grant a summary judgment, I must find that there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986). A party opposing summary judgment 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; 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). In opposing Respondent's motion for summary judgment, Petitioner bears the burden of showing that there are genuine issues of material fact that are disputed. Everett Rehabilitation and Medical Center, DAB No. 1628. It is not sufficient for Petitioner to rely upon mere allegations or denials to defeat the motion and proceed to hearing. Petitioner must, by affidavits or other evidence which set forth specific facts, show that there is a genuine issue for trial. A test for whether an issue is regarded as genuine is "if the evidence [as to that issue] is such that a reasonable jury could return a verdict for the nonmoving party." Anderson, 477 U.S. 242, at 248. In evaluating whether there is a genuine issue as to a material fact, the ALJ must view the facts and the inferences to be drawn from the facts in the light most favorable to the nonmoving party. Pollock v. American Tel. & Tel. Long Lines, 794 F.2d 860, 864 (3^rd Cir. 1986). If Petitioner cannot show by some credible evidence that there exists some genuine issue for trial, then summary judgment is appropriate and Respondent must prevail as a matter of law.

There are no genuine issues of material fact in dispute in this case and CMS is entitled to judgment as a matter of law. Accordingly, summary judgment is appropriate.

2. Petitioner violated the condition-level requirement established by 42 C.F.R. � 498.1441 to have a qualified laboratory director.

It is a condition-level requirement that a CLIA certified laboratory have a qualified laboratory director who is required to assume oversight and responsibility for the laboratory and the results of its testing. See 42 C.F.R. �� 493.1441, 493.1443, 493.1445. The condition-level requirement of 42 C.F.R. � 493.1441 provides:

The laboratory must have a director who meets the qualification requirements of � 493.1443 of this subpart and provides overall management and direction in accordance with � 493.1445 of this subpart.

Section 493.1443 sets forth the following required qualifications:

The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R.

(a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and

(b) The laboratory director must--

(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or

(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and

(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or

(ii) Have at least 2 years of experience directing or supervising high complexity testing; or

(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and--

(i) Be certified and continue to be certified by a board approved by HHS; or

(ii) Before February 24, 2003, must have served or be serving as a director of a laboratory performing high complexity testing and must have at least--

(A) Two years of laboratory training or experience, or both; and

(B) Two years of laboratory experience directing or supervising high complexity testing.

(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or

(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or

(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification.

Section 493.1445 provides that the laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures and record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. Specific responsibilities assigned to the director are set out in the remainder of section 493.1445.

CMS alleges that Richard O'Pere did not have the qualifications required to be laboratory director of Petitioner and that this alone is sufficient grounds for finding a condition-level violation. CMS Brief at 42. I agree.

It is undisputed that Richard O'Pere is not licensed to practice medicine in the State of Illinois and he fails to satisfy the qualification requirements of 42 C.F.R. � 1443(b)(1) or (2). Petitioner has not presented evidence that he holds an earned doctoral degree in chemical, physical, biological, or clinical laboratory science from an accredited institution as defined at 42 C.F.R. � 493.2. Thus, he does not satisfy the qualification requirements of 42 C.F.R. � 1443(b)(3). Petitioner does not allege and has not submitted any evidence that Richard O'Pere might satisfy the qualification requirements of 42 C.F.R. � 1443(b)(4), (5), or (6). ⁽³⁾

In a statement dated December 4, 2004, Petitioner's representative acknowledged that Richard O'Pere does not have the qualifications specified by the regulations for a laboratory director, and so Petitioner attempted to "secure a licensed physician of the State of Illinois" to become laboratory director (Petitioner asserted that as of December 4, 2004, one physician had declined the position, but two were giving the possibility "deep consideration"). In its opposition to the CMS motion for summary judgment, Petitioner alleges that it now has an agreement with a laboratory director (P. Ex. 12). This exhibit purports to be a "contract agreement" executed December 27, 2004, between Petitioner and Francis Thuo Kangethe, M.D., by which Dr. Kangethe agrees to be laboratory director of Petitioner. I assume for purposes of summary judgment that what is represented by this document is true, i.e., that Francis Thuo Kangethe is a medical doctor licensed in the State of Illinois (P. Ex. 11, at 2) and that he has agreed to be laboratory director of Petitioner. Thus, I conclude for purposes of summary judgment that Frances Thuo Kangethe would meet the first qualification requirement of either 42 C.F.R. � 493.1443(b)(1) or (2). However, Petitioner has not presented me any evidence from which I might infer that Frances Thuo Kangethe satisfies the qualification requirements of the second prong of either 42 C.F.R. � 493.1443(b)(1) or (2).

Based on the foregoing, I conclude that Petitioner's laboratory director was not qualified within the meaning of 42 C.F.R. � 493.1443. Therefore, Petitioner did not have a director who met the qualification requirements of section 493.1443, a violation of the condition-level requirement established by section 493.1441. Petitioner's eleventh-hour attempt to contract with Frances Thuo Kangethe, M.D., does not remedy the violation. Because Richard O'Pere was not a qualified laboratory director, at the relevant times Petitioner had no laboratory director ensuring: the quality of laboratory services; that the laboratory environment was appropriate and safe; that results reported were accurate and reliable; that proficiency testing was being done; that quality control and assessment programs were being maintained; that appropriate remedial actions were undertaken; that reports included required information; that qualified consultation was available for clients; that sufficient numbers of trained and qualified people were employed; or ensuring that any of the other duties specified by section 493.1407 were being fulfilled. ⁽⁴⁾ The evidence here is clear that no qualified laboratory director provided overall management and direction of the laboratory, a clear violation of the condition-level requirement of 42 C.F.R. � 493.1441, and that deficiency has not been corrected.

3. There is a basis for the revocation of Petitioner's CLIA certificate.

CMS may impose a principal sanction of suspension, limitation, or revocation of a laboratory's CLIA certificate when, on examination, the laboratory is found to be out of compliance with one or more CLIA conditions. 42 C.F.R. � 493.1806; Edison Medical Laboratories, Inc., DAB No. 1712. I have concluded that Petitioner violated the condition-level requirement of 42 C.F.R. � 493.1441. Accordingly, there is a basis for the revocation of Petitioner's CLIA certificate.

IV. CONCLUSION

For the foregoing reasons, Petitioner's CLIA certificate is revoked effective the date of this decision.

Keith W. Sickendick

Administrative Law Judge

1. Codified as 42 U.S.C. �� 263a, 1302, 1395x(e) (1988). "CLIA" when used in this decision refers to both statutory and regulatory provisions governing the program, unless otherwise indicated.

2. All citations are to the October 1, 2003 version of the Code of Federal Regulations, which was in effect at the time of the May 17, 2004 survey of Petitioner, unless otherwise indicated.

3. Richard O'Pere, in his declaration dated January 4, 2005, indicates in paragraph 11 that he has been certified to take the United States Medical Licensing Examination by the Educational Commission for Foreign Medical Graduates (ECFMG). P. Ex. 6, at 2. I note, however, that Mr. O'Pere never asserts that he has taken such examination to become eligible for licensing as a medical doctor in the United States. Mr. O'Pere also does not assert that such certification by ECFMG amounts to a certification of educational equivalency. See P. Ex. 9.

4. CMS cited nine separate standard-level violations of 42 C.F.R. � 493.1445(e). CMS Ex. 1, at 7-14. Because there was no qualified laboratory director of Petitioner, those deficiencies exist as a matter of law and further analysis is not necessary.