The following is a list of hearing decisions, in hearing decision date
order, related to the CLIA program with informational guidance for each case.
It is current through 12/31/2003. To view the actual text of the hearing
decision click on the case name link under the "Decision Date and Case
Name" column. To view a brief synopsis of each case, click on the
highlighted area under the "Outcome" column. To view the regulatory
authority for the primary issues involved in each case, click on the
highlighted area under the "Regulatory References" column. The Case Citation Reference Guide (PDF 37KB) lists cases and issues most often referenced in the decisions.
Note: The links on this page are to
large PDF documents.
Decision Date and Case Name |
Issues |
Outcome |
Regulatory References |
9/23/1994 [CR334]
Long Medical
Laboratory v. HCFA (PDF 4.7 MB)
|
- Improper PT
- Intentional PT referral
- State laws vs. CLIA
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another
laboratory.
42 CFR
493.1840(b)
Adverse action based on improper referrals in proficiency testing.
|
9/28/1994 [CR335]
Central
Valley Medical Laboratory v. HCFA (PDF 4.7 MB)
|
- Client list
- Directed Plan of Correction
- Immediate Jeopardy
--Pattern of deficiencies
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1832
Directed plan of correction and directed portion of a plan of
correction.
42 CFR
493.1840(a)(7)
Failed to comply with an alternative sanction imposed.
42 CFR
493.1804(d)
Choice of sanction [relationship of deficiencies]
42 CFR
493.1844(c)(6)
The determination that a laboratory's deficiencies pose immediate
jeopardy.
|
2/15/1995 [CR358]
Center
Clinical Laboratory v. HCFA (PDF 4.7 MB)
|
- Effective date
- Immediate Jeopardy
|
For
Petitioner (PDF 1 MB)
|
42 CFR
493.1810(c)(2)(i)
HCFA provides notice at least 5 days before the effective date of
alternative sanctions.
42 CFR
493.1844(c)(6)
The determination that a laboratory's deficiencies pose immediate
jeopardy.
|
7/31/1995 [DAB1526]
Center
Clinical Laboratory v. HCFA (PDF 4.7 MB)
|
- Effective date
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1844(h)(1)
Effective date of adverse action (5 days after notice).
|
2/15/1996 [CR411]
Center
Clinical Laboratory v. HCFA (PDF 4.7 MB)
|
- Immediate Jeopardy (not subject to appeal)
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1844(c)(6)
The determination that a laboratory's deficiencies pose immediate
jeopardy.
42 CFR
493 Subpart H (Participation in Proficiency Testing)
42 CFR 493 Subpart J (Patient Test Management)
42 CFR 493 Subpart K (Quality Control)
42 CFR 493 Subpart P (Quality Assurance)
42 CFR 493 Subpart M (Personnel)
|
9/30/1996 [CR438]
Blanding
Urgent Care Center Laboratory v. HCFA (PDF 4.7
MB)
|
- Improper PT
- Intentional PT referral
- Motive
- Physical transport
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.2
Intentional violation.
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another
laboratory for any analysis which it is certified to perform.
42 CFR
493.1840(b)
Adverse action based on improper referrals in proficiency testing.
|
10/9/1996 [CR439]
Primary
Care Medical Group v. HCFA (PDF 4.7 MB)
|
- Improper PT
- Intentional PT referral
- Lab Director
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another
laboratory for any analysis which it is certified to perform.
42 CFR
493.1441
The laboratory director 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.
|
12/27/1996 [CR451]
Ward
General Practice Clinic v. HCFA (PDF 4.7 MB)
|
- Acceptable Plan of
Correction
- Certificate change
- Immediate jeopardy
|
For HCFA
(PDF 4.7 MB)
|
42 CFR
493.1800
Basis and scope of enforcement procedures.
42 CFR
493.1806(a)
Applicability. HFCA may impose one or more sanctions specified in this
section on a laboratory that is out of compliance with one or more CLIA
conditions.
42 CFR
493.1806(b)
Principal sanction. HCFA may impose any of the three principal CLIA
sanctions.
|
5/30/1997 [CR476]
California
Medical Associates Laboratory v. HCFA (PDF 4.7
MB)
|
- Choice of sanctions
- Lab closure
- Voluntary cessation
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1800
Basis and scope of enforcement procedures.
42 CFR
493.1806(a)
Applicability. HFCA may impose one or more sanctions specified in this
section on a laboratory that is out of compliance with one or more CLIA
conditions.
42 CFR
493.1806(b)
Principal sanction. HCFA may impose any of the three principal CLIA
sanctions.
42 CFR
493.1804(d)
Choice of sanction: Factors considered.
|
7/24/1997 [DAB1624]
Ward
General Practice Clinic v. HCFA (PDF 4.7 MB)
|
- Certificate change
- History of non-compliance
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1800
Basis and scope of enforcement procedures.
42 CFR
493.1804
General considerations of enforcement.
|
8/5/1997 [CR487]
Williams
Bio Medical Laboratory v. HCFA (PDF 4.7 MB)
|
- Burden of proof
- Directed Plan of
Correction
- Standard deficiencies
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1816(b)
Action when deficiencies are not at the condition level. Failure to correct
deficiencies.
42 CFR
493.1820
Ensuring timely correction of deficiencies.
42 CFR
493.1832(c)
Duration of a directed plan of correction.
42 CFR
493.1840(a)(7)
Failed to comply with an alternative sanction imposed under this
subpart.
|
10/21/1997 [CR501]
Thyroid
Specialty Laboratory v. HCFA (PDF 4.7 MB)
|
- Intentional PT referral
- Lab Director
- Motive
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another
laboratory for any analysis which it is certified to perform.
42 CFR
493.1840(b)
Adverse action based on improper referrals in proficiency testing.
|
3/31/1998 [CR527]
Eugene R.
Pocock, M.D. v. HCFA (PDF 4.7 MB)
|
- Affected party (right to hearing)
- Lab Director
- Operator
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.2
Definitions. Operator.
42 CFR
498.2
Definitions. [Affected party].
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that
had its CLIA certificate revoked.
42 CFR
498.40
Request for Hearing. An affected party entitled to a hearing.
|
2/16/1999 [CR576]
BAN
Laboratories v. HCFA (PDF 4.7 MB)
|
- Due process
- Exit Conference
- Immediate Jeopardy
- Re-survey
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1773
Basic inspection requirements for all laboratories issued a CLIA
certificate.
42 CFR
493.1806
Available sanctions.
42 CFR
493.1844(c)(6)
The determination that a laboratory's deficiencies pose immediate
jeopardy.
|
4/30/1999 [CR590]
Melvin C.
Murphy, M.D. v. HCFA (PDF 4.7 MB)
|
- Director/Owner responsibilities
- Intentional PT referral
- State Law vs CLIA
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.801(b)(5)
The laboratory must document and maintain a copy of all proficiency testing
results.
42 CFR
493.1840(b)
Adverse action based on improper referrals in proficiency testing.
|
5/27/1999 [CR597]
Eugene A.
Shaneyfelt, M.D. v. HCFA (PDF 4.7 MB)
|
- Certificate of Waiver
- Director/Operator
- Operator
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.2
Definitions: Operator.
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that
had its CLIA certificate revoked.
|
6/7/1999 [CR599]
Edison Medical Laboratories, Inc. v. HCFA (PDF
4.7 MB)
|
- Accreditation
- Immediate Jeopardy
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1780(a)
Validation inspection.
42 CFR
493.1800
Basis and scope of enforcement procedures.
42 CFR
493.1806
Available sanctions.
42 CFR
493.1844(c)(6)
The determination that a laboratory's deficiencies pose immediate
jeopardy.
|
6/9/1999 [CR600]
Diagnostic
and Educational Laboratory v. HCFA (PDF 4.7 MB)
|
- Choice of sanctions
- Lab Director
- Standard deficiencies
- Written documentation
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1804(d)
Choice of sanction: Factors considered.
42 CFR
493.1816(b)
Action when deficiencies are not at the condition level [i.e., standard
level]. Failure to correct deficiencies.
|
10/6/1999 [C-99-309]
Allstate
Medical Laboratory, Inc. v. HCFA (PDF 4.7 MB)
|
- Affected party
|
HCFA
motion denied (PDF 1 MB)
|
42 CFR
498.2
Definitions. [Affected party]
|
12/7/1999 [CR632]
US
Bio-Chem Medical Laboratories v. HCFA (PDF 4.7
MB)
|
- Certificate of Waiver Lab
- Complainant disclosure
- Duty to cooperate
- Failure to permit inspection
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1771
Condition: Inspection requirements applicable to all CLIA-certified
laboratories.
42 CFR
493.1773
Basic inspection requirements for all laboratories issued a CLIA
certificate.
|
12/21/1999 [C-99-797]
Carlos
A. Cervera, M.D., Director, San Fernando Diagnostic Laboratory, Inc. v.
HCFA (PDF 4.7 MB)
|
- Affected party
|
HCFA
motion denied (PDF 1 MB)
|
42 CFR
498.2
Definitions. [Affected party]
|
12/23/1999
[DAB1713] (PDF 4.7 MB)
Edison Medical Laboratories, Inc. v. HCFA
|
- Burden of proof
- Due process
- Immediate Jeopardy
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1804(a)
Purpose. The enforcement mechanisms.
42 CFR
493.1806
Available sanctions.
42 CFR
493.1844(c)(6)
The determination that a laboratory's deficiencies pose immediate
jeopardy.
|
1/21/2000 [CR642]
Kaulson
Labs v. HCFA (PDF 4.7 MB)
|
- Clerical errors
|
For
HCFA (PDF 1 MB)
|
42 CFR
4931806(a)
Applicability. HFCA may impose one or more sanctions specified in this
section on a laboratory that is out of compliance with one or more CLIA
conditions.
42 CFR
493.1806(b)
Principal sanction. HCFA may impose any of the three principal CLIA
sanctions.
|
5/9/2000 [CR667]
Southfield
Medical Clinic v. HCFA (PDF 4.7 MB)
|
- Acts of employees
- Improper PT
- Unlawful collaboration
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another
laboratory for any analysis which it is certified to perform.
42 CFR
493.803
Condition: Successful participation.
|
6/21/2000 [DAB1731]
US
Bio-Chem Medical Laboratories v. HCFA (PDF 4.7
MB)
|
- Complainant disclosure
- Right to inspect
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1
This part sets forth the conditions that all laboratories must meet to be
certified to perform testing on human specimens under the Clinical Laboratory
Improvement Amendments of 1998 (CLIA).
42 CFR
493.3
Applicability.
42 CFR
493.1773
Basic inspection requirements for all laboratories issued a CLIA
certificate.
|
6/27/2000 [CR679]
Sentinel
Medical Laboratories, Inc. v. HCFA (PDF 4.7 MB)
|
- Affected party
- Due process
- Effective date of prohibition
- Exit Conference
- Lab Director (2 year prohibition)
- Lab Director responsibilities
- Right to hearing
- Voluntary cessation
|
For
HCFA (PDF 1 MB)
|
42 CFR
498.2
Definitions. [Affected party].
42 CFR
493.49(e)
In the event of a noncompliance determination resulting in an HHS
action.
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that
had its CLIA certificate revoked.
42 CFR
493.1884(d)(2)
Suspension, limitation, or revocation of a laboratory's CLIA
certificate.
|
7/18/2000 [CR688]
Oakland
Medical Group, P.C. v. HCFA (PDF 4.7 MB)
|
- Accreditation
- Independent contractor
- Intentional PT referral
- Owner/Operator
- PT collaboration
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.61(b)(1)
Laboratories issued a certificate of accreditation must treat proficiency
testing samples in the same manner as patient samples.
42 CFR
493.6(c)(3)
A laboratory failing to meet the requirements of this section may be subject
to suspension, revocation.
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another
laboratory for any analysis which it is certified to perform.
42 CFR
493.1441
The laboratory director 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.
42 CFR
493.1840(a)
Adverse action based on actions of the laboratory's owner, operator or
employees.
42 CFR
493.1840(b)
Adverse action based on improper referrals in proficiency testing.
|
7/28/2000 [CR690]
Stanley
Boykansky, M.D. v. HCFA (PDF 4.7 MB)
|
- Acceptable Plan of
Correction
- CMS modifying state agency findings
- Intentional PT referral
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.801(b)(1)
The samples must be examined or tested with the laboratory's regular
patient workload.
42 CFR
493.801(b)(3)
Laboratories that perform tests on proficiency testing samples must not
engage in any inter-laboratory communications.
42 CFR
493.801(b)(5)
The laboratory must document and maintain a copy of all proficiency testing
results.
42 CFR
493.1806(a)
Applicability. HFCA may impose one or more sanctions specified in this
section on a laboratory that is out of compliance with one or more CLIA
conditions.
|
9/11/2000 [CR698]
Garden
City Medical Clinic v. HCFA (PDF 4.7 MB)
|
- Employee termination
- Intentional PT referral
- PT collaboration
- Statistics
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.801(b)(3)
Laboratories that perform tests on proficiency testing samples must not
engage in any inter-laboratory communications.
42 CFR
493.1840(a)
Adverse action based on actions of the laboratory's owner, operator or
employees.
|
9/20/2000 [DAB1747]
Kaulson
Labs v. HCFA (PDF 4.7 MB)
|
- Remand
|
For
Petitioner (PDF 1 MB)
|
42 CFR
493.1844
Appeals procedures.
|
12/5/2000 [DAB1755]
Oakland
Medical Group, P.C. v. HCFA (PDF 4.7 MB)
|
- Accreditation
- Improper PT
- Physical transfer
- Standard/Condition level Deficiencies
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.61
Requirements for a certificate of accreditation.
[See 7/18/2000 Oakland Medical Group, P.C. v. HCFA]
|
12/21/2000 [DAB1756]
Stanley
Boykansky, M.D. v. HCFA (PDF 4.7 MB)
|
- Intentional PT referral
- Physical transfer
- Single condition out
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.801(b)(1)
The samples must be examined or tested with the laboratory's regular
patient workload.
42 CFR
493.801(b)(3)
Laboratories that perform tests on proficiency testing samples must not
engage in any inter-laboratory communications.
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another
laboratory for any analysis which it is certified to perform.
42 CFR
493.801(b)(5)
The laboratory must document and maintain a copy of all proficiency testing results.
42 CFR
493.1806(a)
Applicability. HFCA may impose one or more sanctions specified in this
section on a laboratory that is out of compliance with one or more CLIA
conditions.
|
1/24/2001 [CV 00-12209 SVW (CWx)]
Physicians
Independent Laboratory Inc. v. Donna Shalala, DHHS, [et.al.]
(PDF 4.7 MB)
|
- Administrative remedies
- Suspension before hearing
- TRO
|
For DHHS (PDF 1 MB)
|
42 CFR
493.1840(d)
Procedures for suspension or limitation.
|
1/26/2001 [DAB1762]
Sentinel
Medical Laboratories, Inc. v. HCFA (PDF 4.7 MB)
|
- Administrative remedies
- Constitutionality
- Director responsibilities
- 2 year prohibition
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.49(e)
In the event of a noncompliance determination resulting in an HHS
action.
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that
had its CLIA certificate revoked.
42 CFR
493.1844(d)(2)
Suspension, limitation, or revocation of a laboratory's CLIA
certificate.
|
1/30/2001 [DAB1763]
Garden
City Medical Clinic v. HCFA (PDF 4.7 MB)
|
- Accreditation
- Remand
- Summary Judgment
- Witness cross-examination
|
For
Petitioner (PDF 1 MB)
|
42 CFR
493.1844(a)
Appeals procedures. General rules.
42 CFR
493.61(b)(1)
Laboratories issued a certificate of accreditation must treat proficiency
testing samples in the same manner as patient samples.
|
2/15/2001 [No. 00-3138]
Edison
Medical Lab. Inc. v. HCFA (PDF 4.7 MB)
|
- Accreditation
|
For
HCFA (PDF 1 MB)
|
|
3/6/2001 [CR749]
Union City
Diagnostic Laboratory v. HCFA (PDF 4.7 MB)
|
- Immediate Jeopardy
- Quality Control
- Single condition out
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.1701
Condition: Quality assurance. The laboratory's quality assurance
program must evaluate the effectiveness of its policies and procedures.
42 CFR
493.1806(a)
Applicability. HFCA may impose one or more sanctions specified in this
section on a laboratory that is out of compliance with one or more CLIA
conditions.
42 CFR
493.1844(c)(6)
The determination that a laboratory's deficiencies pose immediate
jeopardy.
|
5/10/2001 [CV 00-12209 SVW (CWx)]
Physicians
Independent Laboratory Inc. v. Donna Shalala, DHHS, [et. al.]
(PDF 4.7 MB)
|
- Administrative remedies
- District Court jurisdiction
|
For DHHS (PDF 1 MB)
|
42 CFR
493.1840(d)
Procedures for suspension or limitation.
|
5/14/2001 [CR773]
American
Women's Center v. HCFA (PDF 4.7 MB)
|
- Cease and desist
- Due process (notice receipt)
- Good cause for late filing
- Remand
|
For
HCFA (PDF 1 MB)
[Partial remand]
|
42 CFR
493.1810
Imposition and lifting of alternative sanctions. Notice of noncompliance
and of proposed sanction.
42 CFR
493.1812(b)
Opportunity to respond.
42 CFR
493.1844
Appeals procedures.
|
6/12/2001 [CR779]
Evette
Elsenety, M.D. v. HCFA (PDF 4.7 MB)
|
- Accreditation
- Person (definition)
- Summary Disposition
- 2 year prohibition
|
For
HCFA (PDF 1 MB)
|
42 CFR
493.61(b)(1)
Laboratories issued a certificate of accreditation must treat proficiency
testing samples in the same manner as patient samples.
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that
had its CLIA certificate revoked.
|
6/18/2001 [No. 01-2872 (KSH)]
U.S.A
v. Edison Medical Laboratory Service Corporation (PDF 4.7
MB)
|
- TRO
|
For
USA (PDF 1 MB)
|
42 CFR
493.1846
Civil action.
|
7/31/2001 [Case No. 01-72447]
Preferred
Family Medicine, P.C. [et al.] v. CMS (PDF 4.7
MB)
|
- Accreditation
- TRO
|
For
CMS (PDF 1 MB)
|
42 CFR
493.61(b)(1)
Laboratories issued a certificate of accreditation must treat proficiency
testing samples in the same manner as patient samples.
|
8/3/2001 [CR805]
Mark Gary
Hertzberg, M.D., P.C. v. CMS (PDF 4.7 MB)
|
- Accreditation
- Due process
- Physical transfer
- PT collaboration
- Single condition out
|
For
CMS (PDF 1 MB)
|
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another
laboratory.
42 CFR
493.1806(a)
Applicability. HFCA may impose one or more sanctions specified in this
section on a laboratory that is out of compliance with one or more CLIA
conditions.
|
8/28/2001 [Case No. 01-72447]
Preferred
Family Medicine, P.C. [et. al.] v. Tommy G. Thomson, DHHS, [et. al.]
(PDF 4.7 MB)
|
- District Court jurisdiction
|
For
DHHS (PDF 1 MB)
|
|
10/10/2001 [DAB1790]
Premium Diagnostic Laboratory Inc. v. CMS (PDF 4.7 MB)
|
- Appeal of ALJ dismissal
|
For
CMS (PDF 1 MB)
|
42 CFR
493.1773
Dismissal for cause. (No right to hearing.)
42 CFR
493.1844(b)
Actions that are initial determinations.
|
10/23/2001 [CR829]
RNA
Laboratories, Inc. and Ter-Zakarian Medical Clinic v. CMS (PDF
4.7 MB)
|
- Affected parties
- Director/Owner
- Improper PT referral
- PT collaboration
- PT records
- Statistics
|
For
CMS (PDF 1 MB)
|
42 CFR
498.2
Definitions. [Affected party].
42 CFR
493.801(b)(5)
The laboratory must document and maintain a copy of all proficiency testing
results.
42 CFR
493.1407
Laboratory director responsibilities.
|
11/08/2001 [DAB1796]
Evette
Elsenety, M.D., et. al. v. HCFA (PDF 4.7 MB)
|
- Person (definition)
- 2-year prohibition
|
For
CMS (PDF 1 MB)
|
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that
had its CLIA certificate revoked.
|
12/14/2001 [DAB1805]
Mark Gary Herzberg, M.D., P.C. v. CMS (PDF 4.7 MB)
|
- Improper PT referral
|
For
CMS (PDF 1 MB)
|
42 CFR
493.801
Enrollment and testing of samples
|
12/17/2001 [CR848]
Edward
Ming-Che Lai, M.D. v. CMS (PDF 4.7 MB)
|
- Lab Director
|
For
Petitioner (PDF 1 MB)
|
42 CFR
493.51
Notification requirements for laboratories issued a certificate of
compliance.
42 CFR
493.1773
Basic inspection requirements for all laboratories issued a CLIA
certificate.
|
01/28/2002 [CR863]
Sol Teitelbaum, M.D. v. CMS (PDF 4.7 MB)
|
- Effective date of prohibition
- Lab Director
- Operator
- Right to hearing
- 2-year prohibition
|
For
CMS (PDF 1 MB)
|
42 CFR
493.2
Definitions. (Operator).
42 CFR
493.1407
Laboratory Director responsibilities.
42 CFR
493.1806
Available sanctions.
57 Fed. Reg. 7226 (1992)
(Lab director is an operator; legislative purpose of CLIA.)
|
02/25/2002 [CR875]
Millenium Medical Group v. CMS (PDF 4.7 MB)
|
- Affected party
- Ownership
- 2-year prohibition
|
For
CMS (PDF 1 MB)
|
42 CFR
498.40(c)(1)
Affected party.
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked.
|
03/12/2002 [CR879]
Caroline D. Zohoury, D.O. v. CMS (PDF 4.7 MB)
|
- Denial CLIA application
- Owner/Operator
- 2-year prohibition
|
For
CMS (PDF 1 MB)
|
42 CFR
493.2
Definitions (owner/operator)
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked.
|
03/18/2002 [DAB1820]
RNA Laboratories, Inc., and Ter-Zakarin Medical Clinic v. CMS (PDF 4.7 MB)
|
- Improper PT referral
- Lab Director
|
For
CMS (PDF 1 MB)
|
42 CFR
493.801(a)
Enrollment and testing of samples.
42 CFR
493.1403
Laboratory Director condition of participation.
|
04/15/2002 [CR889]
Gen Sys Incorporated v. CMS (PDF 4.7 MB)
|
- Immediate Jeopardy
- Lab Director qualifications
- Summary Judgment
- Technical Supervisor qualifications
|
For
CMS (PDF 1 MB)
|
42 CFR
493.2
Definitions (Immediate Jeopardy).
42 CFR
493.1441
Laboratory Director.
42 CFR
493.1447
Technical Supervisor.
|
06/19/2002 [CR919]
Dearborn Family Clinic v. CMS (PDF 4.7 MB)
|
- Improper PT referral
- Lab Director responsibilities
- Technical Supervisor qualifications
|
For
CMS (PDF 1 MB)
|
42 CFR
493.801
Enrollment and testing of samples.
42 CFR
493.1441
Laboratory Director.
42 CFR
493.1447
Technical Supervisor.
42 CFR
493.1806(a)
Available sanctions (Applicability).
|
07/29/2002 [CR935]
Emil S. Sitto, M.D., & Associates, PLLC v. CMS (PDF 4.7 MB)
|
- Improper PT referral
- Lab Director responsibilities
- Technical Supervisor qualifications
|
For
CMS (PDF 1 MB)
|
42 CFR
493.61
Requirements for a certificate of accreditation.
42 CFR
493.801
Enrollment and testing of samples.
42 CFR
493.1441
Laboratory Director.
42 CFR
493.1447
Technical Supervisor.
|
07/30/2002 [CR936]
Medical Service Laboratories v. CMS (PDF 4.7 MB)
|
- Immediate Jeopardy
- PT enrollment
|
For
CMS (PDF 1 MB)
|
42 CFR
493.801
Enrollment and testing of samples.
42 CFR
493.1844(c)(6)
Appeals procedures (Immediate jeopardy not subject to appeal)
42 CFR
493.1844(d)(4)(ii)
If an ALJ decision upholds the suspension imposed because of immediate jeopardy, that suspension becomes a revocation.
|
08/01/2002 [CR939]
Carlos A. Cervera, M.D. v. CMS (PDF 4.7 MB)
|
- Constitutional issue
- Lab Director
- Misrepresentation on CLIA application
- 2-year prohibition
|
For
CMS (PDF 1 MB)
|
42 CFR
493.2
Definitions (Owner/operator)
42 CFR
493.643
Fee for determination of program compliance.
42 CFR
493.1840(a)(1)
Misrepresentation in obtaining certificate
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked.
|
08/30/2002 [CR946]
Alaa Ahmed, M.Sc., Ph.D., (Global Esoteric Reference Labs, Inc.) v. CMS (PDF 4.7 MB)
|
- Improper proficiency testing
- Lab Director
- 2-year prohibition
|
For
CMS (PDF 1 MB)
|
42 CFR
493.801
Enrollment and testing of samples
42 CFR
493.1205(e)(1)
Supplies exceeding expiration date
42 CFR
493.1441
Laboratory Director
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked.
|
09/27/2002 [CR957]
Lackawanna Medical Group Laboratory v. CMS (PDF 4.7 MB)
|
- Improper proficiency testing
- 2-year prohibition
|
For
CMS (PDF 1 MB)
|
42 CFR
493.801(b)(4)
Intentional referral of proficiency testing samples.
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked.
|
10/04/2002 [DAB1849]
Sol Teitelbaum v. CMS
|
- Deficiencies during a Lab Director's tenure
- Lab Director
- Summary Judgment
- 2-year prohibition
|
For
CMS (PDF 1 MB)
|
42 CFR
93.2
Definitions (owner/operator)
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked.
|
11/18/2002 [CR975]
Preferred Family Clinic v. CMS (PDF 4.7 MB)
|
- Improper proficiency testing
- Laboratory Director
|
For
CMS (PDF 1 MB)
|
42 CFR
493.801(b)
Testing of proficiency testing samples
42 CFR
493.1441
Laboratory Director
42 CFR
493.1806(a)(b)
Available sanctions (Applicability, Principal sanction)
|
11/27/2002 [CR981]
St. Charles Health Care v. CMS
|
- Standard-level deficiencies not corrected in 12 months
- Unacceptable AOC
- Unsuccessful PT
|
For
CMS (PDF 1 MB)
|
42 CFR
493.2
Definitions (credible allegation of compliance; unsuccessful proficiency testing performance).
42 CFR
493.1816(b)
Failure to correct standard-level deficiencies within 12 months.
42 CFR
493.1840(a)(4)
Failure to comply with reasonable request by HCFA for any information necessary to determine compliance.
|
02/03/2003 [CR999]
Preferred Family Medicine v. CMS
|
- Improper PT
- Physical transport
- PT collaboration
|
For
CMS (PDF 1 MB)
|
42 CFR
493.563
Validation inspections - basis and focus.
42 CFR
493.569(a)
Validation inspection of an accredited laboratory out of compliance with Condition-level requirements.
42 CFR
493.801(b)(3)
Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications.
42 CFR
493.801(b)(4)
Intentional referral of proficiency testing samples.
42 CFR
493.1804(d)
Choice of sanction: Factors considered.
|
03/21/2003 [DAB1870]
Lackawanna Medcial Group Laboratory v. CMS
|
- Improper PT
- Relationship of 42 CFR 493.801(b)(1) and 42 CFR 493.801(b)(4)
- Summary Judgment
|
For
CMS (PDF 1 MB)
|
42 CFR
493.801(b)(1)
The samples must be examined or tested with the laboratory's regular patient workload.
42 CFR
493.801(b)(4)
Intentional referral of proficiency testing samples.
|
04/14/2003 [CR1025]
Medimex Clinical Laboratory v. CMS
|
- Doctrine of Laches
- Immediate Jeopardy
- Lab Director responsibilities
|
For
CMS (PDF 1 MB)
|
42 CFR
493.1403 and 493.1441
Laboratory Director provides overall management and direction.
|
05/01/2003 [DAB1878]
Alaa Ahmed, M.Sc., Ph.D. (Global Esoteric Reference Labs, Inc.) v. CMS
|
- Improper PT
- Lab Director responsibilities
- State licensure issue (lab name)
|
For
CMS (PDF 1 MB)
|
42 CFR
493.801
Enrollment and testing of samples.
42 CFR
493.1441
Lab Director.
|
06/12/2003 [CR1055]
Roy Hollins/Western Reference Laboratory v. CMS
|
- Due process
- Owner
- Untimely filing of request for hearing
- 2-year prohibition
|
For
CMS (PDF 1 MB)
|
42 CFR
498.70(c)
Dismissal of a late filed request.
42 CFR
493.1844(b)
Hearings are conducted in accordance with procedures set forth at 42 CFR Part 498.
42 CFR
493.1844(d)(4)
Effect of ALJ decision.
|
06/16/2003 [Docket No. C-03-203]
Alani Medical Management Corp., d.b.a. Advanced Diagnostic Services Laboratory v. CMS (PDF 4.7 MB)
|
- Affected party (right to hearing)
- Alternative sanction (civil money penalties)
|
Denial of CMS' motion to dismiss and Petitioner's motion for summary judgment (PDF 1 MB)
|
42 CFR
493.1806
Available sanctions.
|
08/26/2003 [CR1079]
Bolsa Medical Group Laboratory, Sheldon Barasch, M.D. v. CMS
|
- Delegation of responsibilities
- Intentional PT referral
- Physical transport of PT sample
- Relationship of 42 CFR 493.801(b)(3) and 42 CFR 493.801(b)(4)
|
For CMS (PDF 1 MB)
|
42 CFR
493.801(b)(3)
Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications.
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another laboratory.
42 CFR
493.1840(a)(8)
Adverse action.
|
08/28/2003 [CR1080]
James Bryant, M.D. v. CMS
|
- Affected party (right to hearing)
- Owner/operator
- 2-year prohibition
|
Dismissal (PDF 1 MB)
|
42 CFR
493.1844
Appeals procedures.
42 CFR
493.2
Definitions (owner/operator)
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked.
|
09/17/2003 [CR1083]
Immuno Biogene, Inc., Charles T. Black, M.D. v. CMS
|
- Improper PT
- Immediate Jeopardy
- Failure to notify CMS of receipt of PT samples from another laboratory
- Lab Director responsibilities
|
For CMS (PDF 1 MB)
|
42 CFR
493.801(b)
Testing of proficiency testing samples.
42 CFR
493.801(b)(3)
Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications.
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another laboratory.
Any laboratory that receives proficiency testing samples from another laboratory for testing must notify CMS of the receipt of those samples.
42 CFR
493.1407
Laboratory director responsibilities.
|
11/14/2003 [CR1109]
White Lake Family Medicine, P.C. v. CMS
|
- Intentional PT referral
- Physical transport
|
For CMS (PDF 1 MB)
|
42 CFR
493.801(b)(3)
Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications.
42 CFR
493.801(b)(4)
The laboratory must not send PT samples or portions of samples to another laboratory.
|
11/18/2003 [CR1111]
William Komaiko, M.D. v. CMS
|
- Affected party (right to hearing)
- Owner/operator
- 2-year prohibition
|
Dismissal (PDF 1 MB)
|
42 CFR
493.1844
Appeals procedures.
42 CFR
493.2
Definitions (owner/operator)
42 CFR
493.1840(a)(8)
Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked.
|