Search Frequenty Asked Questions

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.

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.