|
Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
|
| IN THE CASE OF | |
|
Union City Diagnostic Laboratory, |
DATE: March 6, 2001 |
|
- v - |
|
|
Health Care Financing Administration
|
Docket No.C-99-831 Decision No. CR749 |
| DECISION | |
I sustain the determination of the Health
Care Financing Administration (HCFA) to impose principal administrative
remedies against Petitioner, Union City Diagnostic Laboratory, based on
Petitioner's failure to comply with the Clinical Laboratory Improvement
Amendments of 1988, section 353 of the Public Health Services Act, 42 U.S.C.
� 263(a) (CLIA), and with implementing regulations published at 42 C.F.R.
Part 493. The remedies which I sustain are as follows:
I. Background
Petitioner is a clinical laboratory that is located in
Union City, New Jersey. On August 5, 1999, HCFA notified Petitioner that
it had determined to impose principal remedies against Petitioner based
on findings that were made at a survey of Petitioner that was conducted
by the New Jersey Department of Health and Senior Services (NJDHSS). The
NJDHSS survey was completed on June 14, 1999 (June 1999 survey). HCFA
determined, based on the findings that were made at this survey, that
Petitioner had failed to comply with six CLIA conditions of participation.
HCFA determined additionally that Petitioner's noncompliance was of so
serious a nature as to constitute immediate jeopardy to patient health
and safety. Petitioner requested a hearing to contest HCFA's findings and remedy determinations. The case was assigned at first to other administrative law judges, but, eventually, was transferred to me. I conducted a hearing in Newark, New Jersey, on September 19 and 20, 1999. At the hearing, HCFA presented testimony from the following witnesses:
All of HCFA's witnesses participated as surveyors in the
June 1999 survey of Petitioner's facility. Petitioner presented testimony from the following witnesses:
At the hearing I received into evidence from HCFA exhibits consisting of HCFA Ex. 1 - HCFA Ex. 57. I received into evidence from Petitioner exhibits consisting of P. Ex. 1 - P. Ex. 65.
CLIA requires, among other things, that the Secretary
of the United States Department of Health and Human Services (Secretary)
establish certification requirements for any laboratory that performs
tests on human specimens, and certify through the issuance of a certificate,
that a laboratory meets those requirements. 42 U.S.C. � 263a. The Secretary
published regulations designed to implement the requirements of CLIA.
These regulations are contained in 42 C.F.R. Part 493. The CLIA regulations
set forth the conditions that all laboratories must meet in order to perform
clinical testing. The regulations also set forth enforcement procedures
and hearings and appeals procedures for those laboratories that are found
to be noncompliant with CLIA requirements. The regulations establish both conditions and
standards for participation under CLIA. Conditions of participation
are set forth as general requirements which must be met in order that
a laboratory qualify under CLIA. For example, under 42 C.F.R. � 493.1201
(general quality control for tests of moderate or high complexity), the
condition of participation is stated to include the requirement that a
laboratory must establish and follow written quality control procedures
for monitoring and evaluating the quality of the analytical testing process
of each testing method to assure the accuracy and reliability of patient
test results and reports. Standards of participation are set forth as specific quality
requirements which must be met by a laboratory in order to meet the more
general requirements of conditions of participation. For example, under
42 C.F.R. � 493.1202 (standards for moderate or high complexity testing
or both), specific requirements are set forth which govern the way such
moderate or high complexity tests must be performed by a laboratory. The CLIA regulations authorize HCFA or its designee (such
as NJDHSS) to conduct validation inspections of any accredited or CLIA-exempt
laboratory in order to determine whether the laboratory is in compliance
with CLIA requirements. 42 C.F.R. � 493.1780(a). The regulations confer
enforcement authority on HCFA in order to assure that laboratories comply
with CLIA. 42 C.F.R. � 493.1800. Where HCFA determines that a laboratory
is not complying with one or more CLIA conditions, HCFA may impose principal
remedies against the laboratory which include suspension and/or revocation
of the laboratory's CLIA certificate. 42 C.F.R. � 493.1806(a) and (b).
HCFA may also impose alternative remedies against a noncompliant
laboratory in lieu of or in addition to principal remedies. 42 C.F.R.
� 493.1806(c). Additionally, HCFA may cancel a laboratory's approval to
receive Medicare payments for its services, where the laboratory is found
not to be complying with one or more CLIA conditions. 42 C.F.R. � 493.1807(a). The regulations provide a noncompliant laboratory with
the opportunity to correct its deficiencies so that HCFA may remove alternative
remedies that have been imposed against the laboratory. 42 C.F.R. � 493.1810(e).
A laboratory may make an allegation of compliance once it believes it
has corrected the deficiencies. HCFA will verify whether the deficiencies
have been corrected if it finds the allegation of compliance to be credible
and will lift alternative sanctions effective as of the correction date.
Id. However, the regulations do not afford a laboratory the same
opportunity to have principal, as opposed to alternative, remedies lifted
based on self-correction of deficiencies and an allegation of compliance
by the laboratory. Nor is HCFA obligated to accept as credible a laboratory's
allegation of compliance. The determination to accept or not accept a
noncompliant laboratory's allegation of compliance is a matter of discretion
for HCFA to exercise. A laboratory that is dissatisfied with a determination
by HCFA to impose sanctions against it may request a hearing before an
administrative law judge to contest HCFA's determination. 42 C.F.R. �
493.1844. In most circumstances, a determination to suspend, limit, or
revoke a CLIA certificate will not become effective until after a decision
by an administrative law judge that upholds HCFA's determination to impose
such a remedy. 42 C.F.R. � 493.1844(d)(2)(i). However, if HCFA determines
that a laboratory's failure to comply with CLIA requirements poses immediate
jeopardy to patients, then HCFA's determination to suspend or limit a
laboratory's CLIA certificate will become effective after HCFA gives notice
of its determination and in advance of a hearing and decision by an administrative
law judge. 42 C.F.R. � 493.1844(d)(2)(ii). A suspension automatically
becomes a revocation of the laboratory's CLIA certificate in a case where
an administrative law judge upholds a determination by HCFA to suspend
a laboratory's CLIA certificate based on a finding that the failure by
the laboratory to comply with CLIA requirements poses immediate jeopardy
to the health and safety of patients. 42 C.F.R. � 493.1844(d)(4)(ii). A laboratory that has been found to be posing immediate
jeopardy to patients may appeal the finding or findings of condition-level
deficiencies which are the basis for the imposition of remedies against
that laboratory. But, the laboratory may not appeal HCFA's determination
that the deficiencies pose immediate jeopardy to patients. 42 C.F.R. �
493.1844(c)(6). Nor may a laboratory appeal a determination by HCFA not
to rescind a suspension of that laboratory based on the laboratory's allegations
of compliance where HCFA has concluded that the reason for the suspension
has not been removed or that there is insufficient assurance that the
reason for the suspension will not recur. 42 C.F.R. � 493.1844(c)(3). The standard of proof that is employed at a hearing concerning
HCFA's determination that a laboratory is not in compliance with CLIA
conditions is preponderance of the evidence. HCFA 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,
any prima facie case of noncompliance that is established by HCFA. Hillman
Rehabilitation Center, DAB No. 1611 (1997). II. ISSUES, FINDINGS OF FACT AND CONCLUSIONS OF LAW
The issue in this case is whether Petitioner failed to
comply with one or more CLIA conditions of participation, thereby giving
HCFA the authority to impose principal remedies. In this decision I do not address the question of whether Petitioner's deficiencies - to the extent that it had deficiencies - were at an immediate jeopardy level of noncompliance. As I discuss above, at Part I.B. of this decision, a finding by HCFA that a laboratory manifests immediate jeopardy level deficiencies may not be appealed by the laboratory. Nor do I address the question of whether HCFA should have accepted any of the several plans of correction that Petitioner submitted to address the deficiencies that were identified by NJDHSS at the June 1999 survey. HCFA based its remedy determination in this case on findings by NJDHSS that Petitioner had condition level deficiencies as of the June 1999 survey. As I explain at Part I.B., a laboratory is not entitled to submit a plan of correction to address condition level deficiencies. Moreover, HCFA has discretion to accept or reject any plan of correction that a laboratory submits. I do not have authority to hear and decide whether HCFA used its discretion appropriately to reject a plan of correction.
I make Findings to support my decision in this case. I set forth each Finding below as a separate heading. I discuss each Finding in detail.
The CLIA condition that is stated at 42 C.F.R. � 493.1101
requires a clinical laboratory that performs moderate or high complexity
testing, or both, to employ and maintain a system that provides for: proper
patient preparation; proper specimen collection, identification, preservation,
transportation, and processing; and, accurate result reporting. This system
must assure optimum patient specimen integrity and positive identification
throughout the pre-analytic, analytic, and post-analytic process and it
must satisfy the specific compliance standards that are set forth as part
of the overall condition of participation. Petitioner failed to comply with the condition governing
patient test management of moderate or high complexity testing. Specifically,
Petitioner failed to maintain systems for accurate processing and reporting
of test results. This is made evident by Petitioner's systematic altering
of hematology test results and its reporting of these altered results
to patients' physicians. Physicians depended on Petitioner to produce
accurate hematology test results as an aid in diagnosing patients' medical
conditions and illnesses. Petitioner's systematic reporting of altered
results rendered the results it produced useless, or worse, misleading. Hematology is the study of blood. Tr. at 27. It includes the study of the different cells that are components of blood and their function and structure. Blood cells consist of red and white blood cells. There are several different types of white blood cells. Id. at 28. White blood cells include a group of cells known as "mid cells." Mid cells include a combination of less common varieties of white blood cells. Id. at 31. Increases and decreases in various types of mid cells may signal to a physician the presence of a variety of diseases, including heart disease, tuberculosis, allergies, parasitic diseases and colitis. Tr. at 29; 36 - 38. Hematology testing mainly consists of the counting of quantities of cells in blood, the analysis of different cell types, and the determination of whether observed cells are normal or abnormal. Tr. at 27. Commonly conducted blood tests include a complete blood count (CBC) in which the numbers of major types of blood cells in a known quantity of blood are counted. Id. at 29. A differential test is often done in conjunction with a CBC. Id. at 30. A differential test is designed to break down categories of white blood cells into subgroups of designated cell types. Id. A partial leukocyte differential test examines a specific subgroup of white blood cells. Id. A CBC with a partial leukocyte differential test are among the most commonly performed medical laboratory hematology tests. Id. at 31.A CBC test is almost always an automated test, meaning that the test is performed by an instrument which mechanically analyzes a sample of blood. Tr. at 31. A partial leukocyte differential test may be done via an automated procedure. Alternatively, the test may be done by hand counting cells in a prepared slide of a specimen of blood observed through a microscope. Id. at 31 - 32. Petitioner utilized a blood analyzer machine known as a Cell-Dyn 1600 analyzer. Tr. at 32. This machine enabled Petitioner to do both an automated CBC and an automated partial leukocyte differential. Id. at 32 - 33. The machine uses a method for counting blood cells known as the electrical impedance method. Tr. at 35. The machine operates by sending an electrical pulse through a sample of blood. Different types of blood cells produce changes in the electrical field depending on their size. Id. at 34. The machine aggregates blood cells by size and counts them electrically. Id. at 34 - 35. HCFA offered persuasive evidence to show that Petitioner systematically and inexplicably altered the printout of test results it obtained from the Cell-Dyn 1600 analyzer to produce fictitious test results. Tr. at 40; HCFA Ex. 2 at 2 - 3. The surveyors selected at random from Petitioner's records for review 82 patient test records that Petitioner generated between January 1998 and May 1999. Of those results, 96.3% of lymphocyte results, 100% of mid cell results, and 80.5% of granulocyte results that Petitioner reported to patients' physicians did not reflect the results generated by the analyzer. HCFA Ex. 2 at 2. These inaccuracies became apparent when surveyors compared the printouts generated by Petitioner's Cell-Dyn 1600 analyzer for individual patient tests with the reports that Petitioner generated and sent to patients' physicians. Tr. at 41 - 42. There were systematic discrepancies between the results that the Cell-Dyn 1600 analyzer produced and the test results reports that Petitioner generated and sent to physicians. For example, in the 82 patient records that the surveyors reviewed Petitioner always reported mid cell test results as comprising either one or two percent of the cells counted regardless of the results that were generated by the Cell-Dyn 1600 analyzer. Tr. at 47. The mid cell results that Petitioner reported to physicians were at best meaningless and at worst misleading. Of the 82 records reviewed, Petitioner reported mid cells as comprising one percent of total cells counted in 67 of them and as comprising two percent of total cells counted in 15 of them. HCFA Ex. 2 at 3; HCFA Ex. 5. The percentages of mid cells reported by Petitioner had no relationship to the percentages that were counted by Petitioner's Cell-Dyn 1600 analyzer. Petitioner was unable to produce documentation to show that the percentages of mid cells that it reported had been determined based on accurate manual cell counts. Petitioner could not explain why it disregarded the results obtained from the Cell-Dyn 1600 analyzer and replaced them with what appeared to be arbitrary results. Nor could Petitioner explain rationally why it always found that specimens contained either one percent or two percent mid cells when the normal range of mid cells in a patient exceed one or two percent. HCFA offered additional persuasive evidence of Petitioner's failure to employ a system for proper processing and reporting of hematology test results. The manufacturer's operating manual for the Cell-Dyn 1600 analyzer states that, in order to obtain the most accurate hematology test results, specimens must be processed within eight hours of their collection. Tr. at 65; HCFA Ex. 40 at 33. However, Petitioner on at least one occasion held specimens for as long as 48 hours before processing them. Tr. at 64 - 65; HCFA Ex. 2 at 4. Finally, HCFA offered evidence which showed that Petitioner employed a flawed methodology for assuring the accuracy of its hematology tests. Under CLIA regulations, a laboratory is required to establish a pertinent reference range for tests as an accuracy check for its test results. 42 C.F.R. � 493.1109(d). Petitioner employed an incorrect reference range for mid cell testing utilizing the Cell-Dyn 1600 analyzer. HCFA Ex. 2 at 4. Petitioner's use of an incorrect reference range for mid cell testing is a standard level deficiency. In and of itself, the deficiency does not show that Petitioner failed to comply with the overall condition that is stated under 42 C.F.R. � 493.1101. However, Petitioner's failure to comply with the standard underscores the overall failure by Petitioner to employ a system which assured accurate hematology testing. The evidence offered by HCFA establishes, in sum, that Petitioner simply was not performing hematology tests accurately, nor was it reporting accurate hematology test results. Petitioner did not respond directly to nor deny the evidence that HCFA offered. Indeed, in conversations with the NJDHSS surveyors, Mr. Patel, who is Petitioner's owner and proprietor, essentially admitted to some of the practices that the surveyors discovered. For example, Mr. Patel admitted to the surveyors that he had altered the Cell-Dyn 1600 analyzer counts of mid cells to show results of one or two percent of total cells counted. HCFA Ex. 2 at 3. The explanation that Mr. Patel offered to the surveyors for making this systematic alteration in test results was that all mid cells looked to him like lymphocytes. Tr. at 122. Therefore, he apparently altered the machine test results to account for his own observations. Petitioner offered a variety of additional explanations for its practices. These explanations are contained in the written plans of correction that Petitioner filed in response to the surveyors' findings and in Mr. Patel's testimony at the hearing. I find these explanations to be confusing, contradictory, and, ultimately, unpersuasive. For example, Mr. Patel testified that his manual counts of mid cells were of superior accuracy to those that were generated by the Cell-Dyn 1600 analyzer. Tr. at 194 and 196. He asserted also that some doctors insisted that manual counts of cells be performed. But, he did not explain why he would always make manual partial differentials of mid cells despite the fact that the analyzer was capable of performing the differentials automatically. Furthermore, Mr. Patel not only failed to persuade me that his manual counts were more accurate than those that were performed by the Cell-Dyn 1600 analyzer, he failed to persuade me that his manual counts were objective and reliable. He did not offer any rational explanation as to how Petitioner's manual counts of mid cells always tallied at one or two percent of total cells when the standard range of mid cells allowed for the possibility that, in individual cases, counts of mid cells would greatly exceed two percent. See Tr. at 249 - 250. The explanation that Mr. Patel offered to the surveyors (that all mid cells looked to him like lymphocytes) not only shows a lack of training and understanding of hematology testing by Mr. Patel, but it demonstrates an inadequate understanding on his part of cell appearance and anatomy. Moreover, I do not understand from Mr. Patel's explanations why he would insist on overriding the results that were produced by the Cell-Dyn 1600 analyzer without at least discussing with the machine's manufacturer his discomfort with the results that the analyzer was producing. Yet, Petitioner produced no evidence that Mr. Patel ever participated in such a discussion. Mr. Patel suggested, at one point in his testimony, that some of the test reports that the surveyors had not reviewed showed mid cell counts of three or four percent. But, Petitioner failed to produce any of these alleged test results as evidence. See Id.
The CLIA condition that is stated at 42 C.F.R. � 493.1201
requires a laboratory to establish and follow written quality control
procedures for monitoring and evaluating the accuracy and reliability
of patient test results and reports. Petitioner failed to comply with
this condition. Petitioner failed to follow established quality control
procedures in operating laboratory testing machinery, thereby, producing
and reporting test results that were inaccurate or misleading. In particular,
Petitioner failed to ensure that its Cell-Dyn 1600 analyzer was operated
according to the quality control procedures established by the machine's
manufacturer. Additionally, Petitioner failed to properly calibrate testing
equipment and failed to check test results that suggested inaccuracies
in the testing processes. The Cell-Dyn 1600 analyzer is programmed to "flag" test
results that are suspect. Tr. at 77 - 78. A flag is recorded by the analyzer
as a marginal notation on a test results printout which tells the operator
that there is something wrong with the test result that may require some
intervention or further action by the laboratory. Id. The Cell-Dyn
1600 operator's manual tells the operator what a particular flag potentially
may mean. HCFA Ex. 2 at 7 - 9. The manual gives instructions for further
action to be taken depending on the specific flag or flags that are present
in the test results report. HCFA Ex. 40 at 27 - 31. Typically, the manual
directs that slides of specimens be examined manually to resolve the problem
that is indicated by a flag. Petitioner failed systematically to perform the manual
reviews that were indicated by flags as being necessary. Tr. at 78 - 79.
HCFA identified numerous instances where Petitioner and its staff ignored
flags. For example, on February 19, 1999, a test performed on patient
specimen # 90216619 produced test results with a flag designation of "R3".
HCFA Ex. 5 at 3. The operator's manual for the Cell-Dyn 1600 analyzer
tells the operator that, in the case of an R3 flag, a manual differential
must be performed. HCFA Ex. 40 at 30; Tr. at 82. However, in this instance,
Petitioner failed to perform the indicated manual differential. In another instance, on April 14, 1998, a test performed
on patient # 180 produced a flag designation of "URI." The Cell-Dyn 1600
analyzer operator's manual tells the operator that, in the instance of
a URI flag, the test result is suspect. HCFA Ex. 40 at 28 - 29. Yet, in
this instance, Petitioner reported the flagged result to the patient's
physician without determining the cause of the URI flag. Tr. at 84 - 86. Petitioner offered several explanations of the way in
which it dealt with flagged test results. As with other explanations that
Petitioner offered for its actions, I find these explanations to be confusing,
contradictory, and ultimately, unpersuasive. For example, Mr. Patel told
the surveyors that it is not his usual practice to do many manual differentials.
Tr. at 122 - 123. But, in a plan of correction, Petitioner stated that
it performed manual differentials to confirm automated results, suggesting
that it performed these differentials in all instances. HCFA Ex. 9 at
2. Then, in another statement in the same document, Petitioner asserts
that it performed manual differentials to check flagged results. Id. These contradictory statements were contradicted or confused
even further by Mr. Patel's testimony at the hearing. He testified that
he performed manual differentials with all patient test results
regardless whether the automated results were flagged. Tr. at 188 - 189.
I find this testimony contradicts Mr. Patel's prior statement to the surveyors
that he seldom performed manual differentials. Moreover, his testimony
that he always performed manual differentials is self-serving and without
any corroboration in the record. Petitioner did not produce any corroborating
evidence to show that it had performed manual differentials in all cases.
See Tr. at 194. Petitioner's failures to deal appropriately with flagged test results is not the only evidence to show that Petitioner failed to follow prescribed quality control procedures. As another example, Petitioner failed to properly calibrate its Cell-Dyn 1600 analyzer. HCFA Ex. 2 at 10; Tr. at 137. The manufacturer's specifications require an operator to check the accuracy of the Cell-Dyn 1600 analyzer by first performing a precision test and then by running the calibrators 11 times. Tr. at 130. Petitioner failed to do precision testing. And, in calibrating the analyzer, it ran the calibrators only three times. Id. Petitioner also failed to perform basic maintenance checks on its analyzers. HCFA Ex. 2 at 11; Tr. at 132. It failed to calibrate properly another instrument known as the Technicon RA 1000. Tr. at 144 - 147. And, it failed to check results that were produced by the Technicon RA 1000 that were biased. Tr. at 150 - 152.
The CLIA condition that is stated at 42 C.F.R. � 493.1253 requires that a clinical laboratory performing hematology testing meet the quality control requirements of 42 C.F.R. �� 493.1201 through 493.1221 along with the specific requirements that are set forth at subparts (a) through (d) of 42 C.F.R. � 493.1253. Petitioner failed to comply with the requirements of this condition inasmuch as Petitioner failed to comply with the requirements of the conditions that are stated at 42 C.F.R. � 493.1201. Finding 2.
The CLIA condition that is stated at 42 C.F.R. � 493.1441 requires, among other things, that a laboratory must have a director that provides overall management and direction in accordance with the requirements of 42 C.F.R. � 493.1445. Section 493.1445 provides, in general, that the laboratory director is responsible for the laboratory's overall operation and administration including employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with applicable regulations. Petitioner failed to comply with these requirements. The evidence in this case establishes a generalized failure by Petitioner to perform competently hematology testing. The inescapable inference that is created by the evidence of incompetent testing at Petitioner's laboratory is that its laboratory director failed to provide the direction that is required by 42 C.F.R. �� 493.1441 and 493.1445. As I discuss above, at Findings 1 and 2, Petitioner provided no meaningful rebuttal to overcome this inference.
The CLIA condition that is stated at 42 C.F.R. �
493.1447 requires, among other things, that a clinical laboratory
have a technical supervisor who provides technical supervision in accordance
with the requirements of 42 C.F.R. � 493.1451. Section 493.1451 requires,
generally, that a laboratory's technical supervisor is responsible for
the technical and scientific oversight of the laboratory. It provides
that the supervisor is not required to be on a laboratory's premises at
all times. However, a technical supervisor must be available to provide
necessary supervision of a laboratory's operations. The regulation requires
that a technical supervisor be responsible for resolving a laboratory's
technical problems and ensuring that remedial actions are taken whenever
test systems deviate from the laboratory's established performance specifications.
42 C.F.R. � 493.1451(b)(5). Petitioner failed to comply with this condition. There was a manifest failure by Petitioner to provide adequate supervision of the performance of hematology testing. Indeed, the evidence in this case shows that what supervision that may have been provided resulted in gross mismanagement of hematology tests. As I discuss at Finding 1, Petitioner apparently had a policy of altering its automated hematology test results to produce mid cell counts that were inaccurate and misleading. The reasons Petitioner adhered to this policy are inexplicable. Petitioner has offered no cogent explanation for its policy.
The CLIA condition that is stated at 42 C.F.R. � 493.1701
requires a clinical laboratory performing moderate or high complexity
testing to establish and follow written policies and procedures for a
comprehensive quality assurance program that is designed to monitor and
evaluate the ongoing and overall quality of the laboratory's total testing
process. The quality assurance program must: evaluate the effectiveness
of a laboratory's policies and procedures; identify and correct problems;
assure the accurate, reliable and prompt reporting of test results, and;
assure the adequacy and competency of staff. A laboratory must revise
policies and procedures, as may be necessary, based on the results of
its evaluations. Petitioner failed to comply with this condition. That is apparent from the systematic failures in the conduct of hematology testing by Petitioner. Finding 1. What is apparent from these failures, which extended over a period of at least several months, is that Petitioner was deficient in applying any quality control policies that it may have had to identify and correct erroneous testing practices. At the hearing of this case, Petitioner asserted that it had quality control policies and manuals which the NJDHSS surveyors had failed to obtain or review. I pointed out then, and I reiterate now, that the issue is not whether Petitioner had quality control policies, but whether it implemented them.
HCFA is authorized to impose principal remedies against a laboratory where that laboratory fails to comply with one or more CLIA conditions. 42 C.F.R. � 493.1806(a). In this case, Petitioner failed to comply with six CLIA conditions. Therefore, HCFA was authorized to impose principal remedies against Petitioner. The principal remedies that HCFA determined to impose in this case - cancellation of Petitioner's approval to receive Medicare reimbursement for its services, suspension of Petitioner's CLIA certificate pending a decision in this case, and revocation of Petitioner's CLIA certificate - are specifically authorized by regulation. 42 C.F.R. �� 493.1806(b); 493.1807(a); see 493.1812(b). |
|
| JUDGE | |
|
Steven T. Kessel Administrative Law Judge
|
|