LABORATORY REGISTRY
1997
Once a year the Health Care Financing Administration makes available
to physicians and to the general public specific information
(including information provided to HCFA by the Office of Inspector
General) that is useful in evaluating the performance of laboratories.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) and
implementing regulations at 42 CFR 493.1850 require that this listing
include the following:
(1) A list of laboratories that have been convicted,
under Federal or State laws relating to fraud and abuse, false
billing, or kickbacks.
(2) A list of laboratories that have had their CLIA
certificates suspended, limited, or revoked, and the reasons for the
adverse actions.
(3) A list of persons who have been convicted of
violating CLIA requirements, as specified in section 353(l) of the
PHS Act, together with the circumstances of each case and the
penalties imposed.
(4) A list of laboratories on which alternative sanctions
have been imposed, showing--
(I) the effective date of the sanctions;
(ii) the reasons for imposing them;
(iii) any corrective action taken by the laboratory;
(iv) if the laboratory has achieved compliance, the verified date of
compliance.
(5) A list of laboratories whose accreditation has been
withdrawn or revoked and the reasons for the withdrawal or
revocation.
(6) All appeals and hearing decisions.
(7) A list of laboratories against which HCFA has brought
suit under Section 493.1846 and the reasons for those actions.
(8) A list of laboratories that have been excluded from
participation in Medicare or Medicaid and the reasons for the
exclusion.
Civil settlements reached with clinical laboratories
are also noted.
The Laboratory Registry is compiled for the calendar year preceding
the date the information is made available and also contains corrections of any erroneous statements or information that
appeared in the previous registry.
A final section includes other specific information that
may be useful in evaluating the performance of laboratories, as
specified in 493 CFR 1850(a). It also includes information provided by
CLIA exempt states.
Contacts:
Sheila Ward, E-mail, sward@cms.hhs.gov
Jim Cometa, E-mail, jcometa@cms.hhs.gov
1997 LABORATORY REGISTRY
(as required by Section 353(n) of the Public Health Service Act)
Activity January 1, 1997 through December 31, 1997
1. LABORATORIES SUBJECT TO CLIA THAT HAVE BEEN
CONVICTED, UNDER FEDERAL OR STATE LAWS RELATING TO FRAUD AND ABUSE,
FALSE BILLING, OR KICKBACKS.
The following was supplied by the Office of Inspector General:
Allied Clinical Laboratories, Inc.
2515 Park Plaza
Nashville, Tennessee
EKG Unlimited, Inc.,
3710 Rawlins -- Suite 110
Dallas, Texas
2. LABORATORIES THAT HAVE HAD THEIR CLIA
CERTIFICATES SUSPENDED, LIMITED, OR REVOKED, AND THE REASON FOR THE
ADVERSE ACTION. (Medicare cancellation, a principal sanction, has been
included in this category.)
Eugene M. Tachuk, M.D.
1679 Main Street, Suite A
El Cajon, California 92021
CLIA #05D0566311
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certificate.
EFFECTIVE DATE: March 19, 1997 (Medicare cancellation/CLIA
suspension)
REASON: Immediate and serious threat to the health and safety of
patients found during State Agency complaint survey. Alternative
sanctions were also imposed.
STATUS: Hearing request filed May 19, 1997; hearing held December
8, 1997. The hearing request was withdrawn on the second day of the
hearing and the Administrative Law Judge dismissed case, which
resulted in sanction becoming final. Revocation of CLIA
certification pending.
Eugene R. Pocock, M.D., Director
Watson Medical Laboratories, Inc.
4835 N. Hallmark Parkway
San Bernardino, California 92407
CLIA #05D0575066
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: June 5, 1997
REASON: Immediate and serious threat to the health and safety of
patients found during State Agency complaint survey.
STATUS: Hearing request filed September 13, 1996 was withdrawn
February 27, 1997. Case was dismissed by the Administrative Law
Judge and sanction became final. Suspension of the
laboratory’s CLIA certificate and cancellation of approval to
receive Medicare payment for all laboratory services previously
effectuated September 16, 1996.
Williams Bio Medical Laboratory
Corliss Shelton, M.D., Director
500 West Willow Street
Long Beach, California 90806
CLIA #05D0642670
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: August 5, 1997
REASON: Failure to correct cited deficiencies within 12 months
after State Agency survey in August 1994.
STATUS: Hearing request was filed December 2, 1995. The
Administrative Law Judge upheld sanction in decision dated August
5, 1997. Cancellation of the laboratory’s approval to receive
Medicare payment for all laboratory services was previously
effectuated December 18, 1995.
Awad S. Anthony, M.D.
dba California Medical Associates Laboratory
2775 West Pico Boulevard
Los Angeles, California 90006
CLIA #05D0711870
SANCTION: Suspension of CLIA certification.
EFFECTIVE DATE: June 12, 1997
REASON: Condition level non-compliance, including immediate and
serious threat to the health and safety of patients.
STATUS: Hearing request filed May 14, 1996. The Administrative Law
Judge upheld sanction in decision dated May 30, 1997. Cancellation
of approval to receive Medicare payment for all laboratory services
was previously effectuated April 1, 1996.
Paul C. Boynton, M.D., Director
Clinical Laboratory of Hemet
850 East Latham Avenue, Suite A
Hemet, California 92543
CLIA #05D0863964
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services and revocation of CLIA certificate.
EFFECTIVE DATE: March 18, 1997 (Medicare cancellation)
May 2, 1997 (Revocation)
REASON: Improper referral of proficiency testing to another
laboratory found as a result of a State Agency survey.
Ahsan Qazi, M.D., Director
Qazi Medical Group
264 N. Highland Springs Avenue #2A
Banning, California 92220
CLIA #05D0865163
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services and revocation of CLIA certificate.
EFFECTIVE DATE: December 19, 1997 (Medicare cancellation)
REASON: Due to revocation effective October 31, 1997 of Draw One
Arterial Laboratory Inc. in Riverside, CA. CLIA regulations
prohibit the owner, operator or director of a laboratory from
owning, operating or directing another laboratory for a period of
two years from the date of revocation. Ahsan Qazi, M.D., was the
director of Draw One Arterial Laboratory Inc. at the time its CLIA
certification was revoked.
STATUS: Hearing filed December 10, 1997.
Ivan Serdar, M.D., Director
BCL Clinical Labs
13140 Telegraph Road, Unit A6
Santa Fe Springs, California 90670
CLIA #05D0868130
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certificate.
EFFECTIVE DATE: January 29, 1997 (Medicare cancellation/CLIA
suspension)
March 29, 1997 (Revocation)
REASON: Immediate and serious threat to the health and safety of
patients found during State Agency complaint survey of December 19,
1996. Alternative sanctions were also imposed.
Andrew T. Trapalis, M.D., Director
Metro Medical Clinic
10259 Folsom Blvd., Suite B
Rancho Cordova, California 95670
CLIA #05D0869566
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certificate.
EFFECTIVE DATE: September 7, 1997 (Medicare cancellation and
suspension)
November 1, 1997 (Revocation)
REASON: Failure to provide an acceptable plan of correction for
deficiencies found during State Agency survey, which was initiated
when it was reported that the laboratory had been performing high
complexity testing without proper CLIA certification. The survey
found that the laboratory was performing HIV testing without the
required state licensure. Alternative sanctions were also imposed.
Ahsan Qazi, M.D., Director
Draw One Arterial Laboratory Inc.
12155 Magnolia Avenue, Suite 3B
Riverside, California 92503
CLIA #05D0872676
SANCTION: Cancellation of approval to receive Medicare payment for all
laboratory services, suspension and revocation of CLIA certificate.
EFFECTIVE Date: September 19, 1997 (Medicare cancellation and
suspension)
October 31, 1997 (Revocation)
REASON: Immediate and serious threat to the health and safety of
patients found during State Agency complaint survey. Alternative
sanctions were also imposed.
STATUS: Hearing request filed.
Editha Bernardo / Ernesto Niebres, Owners
Ace Medilab Services
1110 Artesia Blvd., Suite J
Cerritos, California 90703
CLIA #05D0888693
SANCTION: Cancellation of approval to receive Medicare payment for all
laboratory services, suspension and revocation of CLIA certificate.
EFFECTIVE DATE: November 21, 1997 (Medicare cancellation and
suspension)
REASON: Immediate and serious threat to the health and safety of
patients found during State Agency complaint survey. The laboratory
was operating without a qualified director since May 1996. Alternative
sanctions were also imposed.
STATUS: CLIA certification revoked.
Joaquin Jimenez, Owner
Pulmonary Testing Services
671 South Mollison Avenue, Suite F
El Cajon, California 92020
CLIA #05D0908427
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certificate.
EFFECTIVE DATE: October 26, 1997 (Medicare cancellation and
suspension)
December 12, 1997 (Revocation)
REASON: Immediate and serious threat to the health and safety of
patients found during State Agency complaint survey. The laboratory
was operating without a director. Alternative sanctions were also
imposed.
Andrew T. Trapalis, M.D., Director
Metron Medical Group
aka Watt Avenue Medical Clinic
3428 Watt Avenue
Sacramento, California 95821
CLIA #05D0913047
SANCTION: Cancellation of approval to receive Medicare payment for
the specialty of hematology; CLIA limitation in the area of
hematology.
EFFECTIVE DATE: April 20, 1997
REASON: Failure to provide an acceptable plan of correction for
deficiencies found during State Agency survey. Alternative
sanctions were also imposed.
STATUS: Revocation of CLIA certification pending due to the
revocation effective November 1, 1997 of Metro Medical Clinic in
Rancho Cordova. CLIA regulations prohibit the owner, operator or
director of a laboratory from owning, operating or directing
another laboratory for a period of two years from the date of
revocation. Both Metron Medical Group and Metro Medical Clinic are
owned byAndrew T. Trapalis, M.D.
Andrew T. Trapalis, M.D., Director
Metron Medical Group #2
601 Court Street
Jackson, California 95642
CLIA #05D0928575
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services.
EFFECTIVE DATE: December 2, 1997 (Medicare cancellation)
REASON: Due to the revocation effective November 1, 1997 of Metro
Medical Clinic in Rancho Cordova. CLIA regulations prohibit the
owner or operator including director of a laboratory with a revoked
CLIA regulations prohibit the owner, operator or director of a
laboratory from owning, operating or directing another laboratory
for a period of two years from the date of revocation. Both Metron
Medical Group #2 and Metro Medical Clinic are owned by
Andrew T. Trapalis, M.D.
STATUS: CLIA certification revoked.
Robert C. Jacobs, M.D.
4545 E. 9th Avenue
Denver, Colorado 80220
CLIA #06D0920836
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services and limitation of certification in the area
of hematology.
EFFECTIVE DATE: October 31, 1997
REASON: Proficiency testing failure in hematology.
STATUS: Certificate limited for hematology.
Foster Ian Phillips, M.D.
40 Hart Street
New Britain, Connecticut 060652
CLIA #07D0708740
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: December 1, 1997
REASON: Condition level non-compliance.
Luis L. Ragunton, M.D.
98-1079 Moanalua Road #440
Aiea, Hawaii 96701
CLIA #12D0706947
SANCTION: Cancellation of approval to receive Medicare payment for all
laboratory services, suspension and revocation of CLIA certification.
EFFECTIVE DATE: November 10, 1997 (Medicare cancellation and
suspension)
December 26, 1997 (Revocation)
REASON: Failure to submit an acceptable plan of correction for
deficiencies cited at the May 9, 1997 survey of the laboratory.
Edward O. Leonard, Ph.D., Director
Mahendra Patel - Manager/General Supervisor
Delm Medical Laboratory
1812 Broadway
Melrose Park, Illinois 60160-2039
CLIA #14D0416374
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, limitation of CLIA certification in
cytology, limitation of Medicare approval in cytology, suspension
and revocation of CLIA certification.
EFFECTIVE DATE: May 12, 1997 through August 13, 1997 (Limitation of
CLIA certificate and limitation of Medicare approval in the
cytology subspecialty area).
August 14, 1997 (Medicare cancellation and CLIA suspension)
September 28, 1997 (Revocation)
REASON: Immediate jeopardy conditions were found in the cytology
subspecialty area, in addition to other condition level
non-compliance. The laboratory failed to submit an acceptable plan
of correction.
STATUS: Laboratory closed.
Ara M. Minasian, Director
Avenue Medical Laboratory
16234 South Louis Avenue
South Holland, Illinois 60473-2260
CLIA #14D0420452
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, and suspension of CLIA certification.
EFFECTIVE DATE: December 20, 1997
REASON: Laboratory failed to submit an acceptable plan of
correction for condition level non-compliance.
STATUS: Revocation of CLIA certification pending hearing decision.
Nafees W. Qadri, M.D., Director
Northshore Clinical Laboratories, Inc.
2353 West Birchwood Avenue
Chicago, Illinois 60645-1738
CLIA #14D0426602
SANCTION: Cancellation of approval to receive Medicare payment and
limitation of CLIA certification in cytology.
EFFECTIVE DATE: June 26, 1997
REASON: Condition level non-compliance. Conditions present cytology
subspecialty area caused immediate jeopardy to patients.
C. R. Carmichael, M.D., Director
803A Americana Drive
Troy, Illinois 62294-2037
CLIA #14D0434521
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certification.
EFFECTIVE DATE: December 10, 1997 (Medicare cancellation and CLIA
suspension)
REASON: Laboratory failed to submit a plan of correction.
STATUS: CLIA certification revoked.
K. Michael Baker, M.D., Director
Bandy’s Pharmacy, Inc.
1413 West Whittaker
P. O. Box 546
Salem, Illinois 62881-0546
CLIA #14D0894753
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certification.
EFFECTIVE DATE: September 18, 1997 (Medicare cancellation and CLIA
suspension)
November 1, 1997 (Revocation)
REASON: Condition level non-compliance. Laboratory failed to submit
a plan of correction.
Anne E. Niedenthal, M.D., Director
L G M LLC
1625 Sheridan Road
Wilmette, Illinois 60091
CLIA #14D0907974
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certification.
EFFECTIVE DATE: April 24, 1997 (Medicare cancellation and
suspension)
June 3, 1997 (Revocation of CLIA certificate).
REASON: Laboratory failed to submit a plan of correction.
Ward General Practice Clinic
10514 Jefferson Highway
River Ridge, Louisiana 70123
CLIA #19D0897371
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services.
EFFECTIVE DATE: March 2, 1997
REASON: Lab director owned another CLIA laboratory that had its
certification revoked.
STATUS: Hearing request filed.
Leon W. Berube, M.D.
97 Old Route 5
Mechanicsville, Maryland 20659
CLIA #21D0209627
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, and revocation of CLIA certification.
EFFECTIVE DATE: April 17, 1997 (Medicare cancellation of Medicare)
June 2, 1997 (Revocation)
REASON: Condition level non-compliance and failure to submit
acceptable plan of correction.
Surendra D. Morjaria, M.D.
3000 Manchester Road
Manchester, Maryland 21102
CLIA #21D0215440
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, and suspension of CLIA certification.
EFFECTIVE DATE: April 2, 1997
REASON: Condition level non-compliance and failure to submit an
acceptable plan of correction.
STATUS: Compliance with CLIA conditions achieved. Re-certification
to certificate of waiver issued at the request of laboratory.
Laurie B. Glanz, Director
35 Church
Mount Clemens, Michigan 48043-2331
CLIA #23D0363658
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certification.
EFFECTIVE DATE: January 28, 1997 (Medicare cancellation/CLIA
suspension).
March 9, 1997 (Revocation)
REASON: Failure to submit a plan of correction and to pay CLIA
fees.
Lonnie Joe Jr., M.D., Director
15901 West Nine Mile Road, Suite 400
Southfield, Michigan 48075-4883
CLIA #23D0364884
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certification.
EFFECTIVE DATE: May 13, 1997 (Medicare cancellation/CLIA
suspension)
June 27, 1997 (Revocation)
REASON: Condition level non-compliance causing immediate jeopardy
to the health and safety of the laboratory’s patients.
Ronald Hines, M.D., Director
Allied Medical Laboratory, Inc.
G-8445 South Saginaw
Grand Blanc, Michigan 48439
CLIA #23D0373014
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certification.
EFFECTIVE DATE: September 2, 1966 (Medicare cancellation)
September 2, 1996 - November 30, 1997 (Suspension)
December 1, 1997 (Revocation)
REASON: Condition level non-compliance.
STATUS: Hearing request filed October 8, 1996. On December 1, 1997,
the Administrative Law Judge dismissed the case because of the
laboratory’s failure to participate in the hearing
proceedings.
Thabet R. Abbarah, M.D., Director
4000 Highland Road, Suite 115
Waterford, Michigan 48328-2163
CLIA #23D0692131
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certification.
EFFECTIVE DATE: September 18, 1997 (Medicare cancellation/CLIA
suspension)
November 1, 1997 (Revocation)
REASON: Condition level non-compliance. Laboratory failed to submit
a plan of correction.
Burton J. Bacher, M.D., Director
Drs. Bacher, Isaacs, Tabbilos
25779 Kelly Road
Roseville, Michigan 48066-4973
CLIA #23D0700737
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services and suspension of CLIA certification.
EFFECTIVE DATE: December 30, 1996 - June 22, 1997 (Medicare
cancellation).
March 18 - June 22, 1997 (Suspension)
REASON: Condition level non-compliance.
STATUS: Agreement negotiated in lieu of a hearing determination.
As part of the agreement, the March 18, 1997 revocation, in
place before the hearing request was filed, was rescinded and
categorized as a suspension. Effective June 23, 1997, the
laboratory was authorized to perform only those tests approved
under a Provider-Performed
Microscopy Procedures certificate for at least a two year period
from the effective date of suspension.
Cesar A. Sturla, M.D., Director
Cascade Laboratory
(Formerly known as, Livonia Internal Medicine Associates)
20311 Farmington Road
Livonia, Michigan 48152-1411
CLIA #23D0860681
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services and suspension of CLIA certification.
EFFECTIVE DATE: May 15 1997 - June 9, 1997
REASON: Condition level non-compliance causing immediate jeopardy
to the health and safety of the laboratory’s patients.
Laboratory failed to submit an acceptable plan of correction.
STATUS: Cancellation of Medicare payment and suspension of CLIA
certificate lifted on June 10, 1997. Laboratory submitted an
acceptable plan of correction and supporting evidence to confirm
compliance. On June 26, 1997 a directed plan of correction was
imposed to assure compliance with applicable CLIA requirements.
Arnold J. Taft, Ph.D.
Citilab, Inc.
333 Broad Street
Elizabeth, New Jersey 07208
CLIA #31D0900247
SANCTION: Suspension of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certification.
EFFECTIVE DATE: May 2, 1997 (Medicare suspension/CLIA suspension)
July 7, 1997 (Revocation)
REASON: Condition level non-compliance causing immediate jeopardy
to the health and safety of the laboratory’s patients.
Laboratory obtained and tested blood samples from unknown and/or
unidentified sources and assigned the results obtained to real
patients.
STATUS: Laboratory closed.
Richard Gordon, M.D.
American Women’s Center
157 South Main Street
Phillipsburg, New Jersey 08865
CLIA #31D0914104
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: September 10, 1997
REASON: Failure to submit an acceptable plan of correction.
Richard Gordon, M.D.
American Women’s Center
34 East Jersey Street
Elizabeth, New Jersey 07201
CLIA #31D0914105
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: September 10, 1997
REASON: Failure to submit an acceptable plan of correction.
Richard Gordon, M.D.
American Women’s Center
1 Alpha Avenue, Suite 27
Voorhees, New Jersey 08043
CLIA #31D0914106
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: September 10, 1997
REASON: Failure to submit an acceptable plan of correction.
Hobart C. Price, M.D.
119-06 Guy R. Brewer Blvd.
Jamaica, New York 11434
CLIA # 33D0152534
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: August 1, 1997
REASON: Failure to submit an acceptable plan of correction.
Owen J. O’Neill, M.D.
311 North Street
White Plains, New York 10605
CLIA #33D0662988
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: August 15, 1997
REASON: Failure to submit an acceptable Plan of Correction
Joseph Putignano, M.D.
Gramatan Urology
26 Fondfield Road West
Bronxville, New York 10708
CLIA #33D0863122
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: August 1, 1997
REASON: Failure to submit an acceptable plan of correction.
Wilfred L. Anderson, M.D., Director
5 Severance Circle #818
Cleveland, Ohio 44118-1513
CLIA #36D0336888
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: January 23, 1997 (Revocation of CLIA certificate).
REASON: Condition level non-compliance.
STATUS: Laboratory’s certification had been suspended and
Medicare authorization cancelled effective December 14, 1996.
Charles S. Johnson, M.D., Director
2020 West 3rd Street
Dayton, Ohio 45417-2540
CLIA #36D0890424
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certification.
EFFECTIVE DATE: August 31, 1997 (Medicare cancellation/CLIA
suspension)
October 14, 1997 (Revocation)
REASON: Validation survey found condition level non-compliance.
Laboratory failed to submit a plan of correction.
Frank Abbati, M.D., Director
3100 West Central Avenue, Suite 114
Toledo, Ohio 43606
CLIA #36D033116
SANCTION: Accreditation organization imposed action of cease
testing for problem analyte(s).
EFFECTIVE DATE: November 3,1997
REASON: Repeated unsuccessful proficiency testing.
STATUS: Laboratory has failed to remit cease testing agreement to
accreditation organization.
Hunter Clinic
901 S.W. 33rd Street
Oklahoma City, Oklahoma 73109
CLIA #37D0470540
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: April 10, 1997 (Revocation)
REASON: Intentional referral of proficiency testing specimens to
another laboratory.
Laboratorio Clinico Bacteriologico Del Oeste
27 Brau Street
Cabo Rojo, Puerto Rico 00603
CLIA #40D0876005
SANCTION: Suspension of CLIA certification.
EFFECTIVE DATE: November 14, 1997
REASON: Condition level non-compliance.
STATUS: Re-certified after submission of documentation supporting
the correction of the deficiencies cited.
Warner B. Massey M.D., Pathology Services
119 E. Houston Street
Tyler, Texas 75702
CLIA #45D0659703
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: August 29, 1997
REASON: Condition level non-compliance causing immediate and
serious threat to the health and safety of patients.
Ban Laboratories
P.O. Box 150247
Dallas, Texas 75315
CLIA #45D0683772
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services, suspension and revocation of CLIA
certification.
EFFECTIVE DATE: April 15, 1997 (Medicare cancellation)
April 15, 1997 (Suspension)
REASON: Condition level non-compliance. Immediate and serious
threat to the health and safety of patients was found during a
complaint investigation. .
STATUS: Revocation of CLIA certification pending hearing.
Professional Labs
1130 Pecan, Suite 2
McAllen, Texas 78501
CLIA #45D0914232
SANCTION: Revocation of CLIA certification.
EFFECTIVE DATE: January 25, 1997
REASON: Laboratory did not adhere to alternative sanction imposed
in 1996.
IHC Health Center - Ephraim
525 N. Main
Ephraim, Utah 84627
CLIA #46D0662411
SANCTION: Cancellation of approval to receive Medicare payment and
limitation of CLIA certification for endocrinology, hematology and
sodium.
EFFECTIVE DATE: March 10, 1997 (endocrinology)
October 31, 1997 (hematology and sodium)
REASON: Proficiency testing failure in endocrinology, hematology
and sodium.
Ronald J. Payne, M.D., FACP
550 E. 1400 N #B
Logan, Utah 84321
CLIA #46D0678580
SANCTION: Suspension of approval to receive Medicare/Medicaid
payment and suspension of CLIA certification.
EFFECTIVE DATE: May 30, 1997
REASON: Failure to submit an acceptable Plan of Correction
STATUS: Reinstated October 1, 1997.
Howard Levine, Director
Women’s Health Care Center
1833 Harvard Avenue
Seattle, Washington 98122-2229
CLIA #50D0863424
SANCTION: Limitation of State license.
EFFECTIVE DATE: May 10, 1997
REASON: Condition equivalent non-compliance in proficiency testing,
quality control and quality assurance.
Clarence G. Novotny, M.D., Director
Healthcare Center
15425 North Greenway-Hayden Loop, Suite A-300
Scottsdale, Arizona 85260
CLIA #52D0395068
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services and revocation of CLIA certification.
EFFECTIVE DATE: December 31, 1996 (Medicare cancellation)
March 21, 1997 (Revocation)
REASON: Performing moderate complexity testing after CLIA
certificate had been terminated on December 31, 1996, per the
laboratory’s request; history of condition level
non-compliance; and failure to correct deficiencies cited during
past surveys.
Nina B. Vicente, M.D., Director
Vicente Office Lab
2040 West Wisconsin Avenue #419
Milwaukee, Wisconsin 53233 - 2012
CLIA #52D0865925
SANCTION: Cancellation of approval to receive Medicare payment for
all laboratory services and suspension of CLIA certification. .
EFFECTIVE DATE: February 19-April 14, 1997.
REASON: Laboratory failed to submit a plan of correction.
STATUS: An acceptable plan of correction and supporting evidence to
confirm correction of deficiencies was submitted on April 15, 1997.
3. A LIST OF PERSONS CONVICTED OF VIOLATING
CLIA REQUIREMENTS AS SPECIFIED IN SECTION 353(L) OF THE PUBLIC HEALTH
SERVICEACT, WITH THE CIRCUMSTANCES OF EACH CASE AND THE PENALTIES
IMPOSED:
None
4. A LIST OF LABORATORIES ON WHICH ALTERNATIVE
SANCTIONS HAVE BEEN IMPOSED, SHOWING--
(I) THE EFFECTIVE DATE OF THE SANCTIONS:
(iii) THE REASONS FOR IMPOSING THEM;
(iii) ANY CORRECTIVE ACTION TAKEN BY THE LABORATORY; AND
(iv) IF THE LABORATORY HAS ACHIEVED COMPLIANCE, THE VERIFIED DATE OF
THE COMPLIANCE;
Eugene M. Tachuk, M.D.
1679 Main Street, Suite A
El Cajon, California 92021
CLIA #05D0566311
SANCTION: Civil Money Penalty, $9,150
Directed Portion of a Plan of Correction
EFFECTIVE DATE: March 16, 1997 through March 18, 1997 at $3,050 per
day.
REASON: Immediate and serious threat to the health and safety of
patients found during State agency complaint survey. The
laboratory’s CLIA certificate was suspended March 19, 1997
and later revoked.
Ivan Serdar, M.D., Director
BCL Clinical Labs
13140 Telegraph Road, Unit A6
Santa Fe Springs, California 90670
CLIA #05D0868130
SANCTION: Civil Money Penalty, $20,000
Directed Portion of a Plan of Correction
EFFECTIVE DATE: January 27, 1997 through January 28, 1997 at
$10,000 per day.
REASON: Immediate and serious threat to the health and safety of
patients found during State agency complaint survey. The
laboratory’s CLIA certificate was subsequently suspended
January 29, 1997 and revoked March 29, 1997.
Andrew T. Trapalis, M.D., Director
Metro Medical Clinic
10259 Folsom Blvd., Suite B
Rancho, Cordova, California 95670
CLIA #05D0869566
SANCTION: Civil Money Penalty, $9,000
Directed Portion of a Plan of Correction
EFFECTIVE DATE: September 4 - September 6, 1997 for three days at
$3,000 per day.
REASON: Failure to provide an acceptable plan of correction for
deficiencies found during State agency survey initiated when it was
reported that the laboratory had been performing high complexity
testing without proper CLIA certification. The laboratory’s CLIA
certificate was subsequently revoked.
Ahsan Qazi, M.D., Director
Draw One Arterial Laboratory, Inc.
12155 Magnolia Avenue, Suite 3B
Riverside, California 92503
CLIA #05D0872626
SANCTION: Civil Money Penalty, $30,000
Directed Portion of a Plan of Correction
EFFECTIVE DATE: September 16 - September 18, 1997 for three days at
$10,000 per day.
REASON: Immediate and serious threat to the health and safety of
patients found during State agency complaint survey. The
laboratory’s CLIA certificate was subsequently suspended on
September 19 and revoked on October 31, 1997.
Joaquin Jimenez, Owner
Pulmonary Testing Services
671 South Mollison Avenue, Suite F
El Cajon, California 92020
CLIA #05D0908427
SANCTION: Civil Money Penalty, $30,000
Directed Portion of a Plan of Correction
EFFECTIVE DATE: October 23 - October 25, 1997 for three days at
$10,000 per day
REASON: Immediate and serious threat to the health and safety of
patients found during State agency complaint survey. The
laboratory’s CLIA certificate was subsequently suspended on
October 26 and revoked December 12, 1997.
Andrew T. Trapalis, M.D., Director
Metron Medical Group
(aka Watt Avenue Medical Clinic)
3428 Watt Avenue
Sacramento, California 95821
CLIA #05D0913047
SANCTION: Civil Money Penalty, $3,000
Directed Plan of Correction
State On-site Monitoring
EFFECTIVE DATE: April 1, 1997 for one day (Civil Money Penalty)
April 20, 1997 (Directed Plan of Correction; State On-site
Monitoring)
REASON: Failure to provide an acceptable plan of correction for
deficiencies found during State agency survey. The
laboratory’s CLIA certificate was subsequently revoked.
Edward O. Leonard, Ph.D., Director
Mahendra Patel, Manager/General Supervisor
Delm Medical Laboratory
1812 Broadway
Melrose Park, Illinois 60160-2039
CLIA #14D0416374
SANCTION: Directed Plan of Correction
Directed Portion of a Plan of Correction.
EFFECTIVE DATE: May 12, 1997
REASON: Condition level non-compliance in the cytology subspecialty
area resulting in immediate jeopardy to the laboratory’s
patients. Laboratory failed to submit a plan of correction.
STATUS: Laboratory closed without notice. CLIA certification
revoked September 28, 1997.
Dr. Nafees W. Qadri, Director
Northshore Clinical Laboratories, Inc.
2353 West Birchwood Avenue
Chicago, Illinois 60645-1738
CLIA #14D0426602
SANCTION: Directed Plan of Correction
Directed Portion of a Plan of Correction.
EFFECTIVE DATE: June 26, 1997
REASON: Condition level non-compliance in the cytology subspecialty
area resulting in immediate jeopardy to the laboratory’s
patients.
STATUS: Laboratory ceased testing in the cytology subspecialty
area. Limitation of laboratory’s CLIA certificate in the
cytology subspecialty was imposed on June 26, 1997.
Dr. John Passmann, M.D.
Doctor’s Hospital of Hyde Park, Inc.
5800 South Stony Island
Chicago, Illinois 60637
CLIA #14D0710677
SANCTION: Directed Plan of Correction
EFFECTIVE DATE: July 15, 1996 - January 7, 1997
REASON: Laboratory failed to demonstrate that it was capable of
preventing recurring deficiencies. The deficiencies impacted the
laboratory’s ability to ensure accurate and reliable test
results.
STATUS: The laboratory was found in compliance with the directed
plan of correction during follow-up survey.
Lonnie Joe Jr., M.D., Director
15901 West Nine Mile Road, Suite 400
Southfield, Michigan 48075-4883
CLIA #23D0364884
SANCTION: Directed Portion of a Plan of Correction.
EFFECTIVE DATE: May 13, 1997
REASON: Condition level non-compliance resulting in immediate
jeopardy to the health and safety of the laboratory’s
patients.
STATUS: Certification revoked June 27, 1997.
Cesar A. Sturla, M.D., Director
Cascade Laboratory
(Formerly, Livonia Internal Medicine Associates)
20311 Farmington Road
Livonia, Michigan 48152 - 1411
CLIA #23D0860681
SANCTION: Directed Plan of Correction.
EFFECTIVE DATE: June 26 - December 18, 1997
REASON: Condition level non-compliance resulting in immediate
jeopardy to the health and safety of the laboratory’s
patients. Laboratory submitted revised plan of correction and
supporting evidence to confirm compliance.
Edward Mason, M.D.
Ban Laboratories
4248 Fitzhugh, Suite A
P.O Box 150247
Dallas, Texas 75210
CLIA #45D0914232
SANCTION: Directed Portion of a Plan of Correction
EFFECTIVE DATE: April 15, 1997
REASON: Condition level non-compliance resulting in immediate
jeopardy to the health and safety of the laboratory’s
patients, discovered during a state agency complaint survey.
STATUS: Pending hearing decision.
Professional Labs
1130 Pecan, Suite 2
McAllen, Texas 78501
CLIA #45D0914232
[This listing contains additional information to the 1996 Laboratory
Registry entry for this laboratory.]
SANCTION Civil Monetary Penalty, $20,800
Directed Portion of a Plan of Correction.
EFFECTIVE DATE: May 18, 1996 (Civil Monetary Penalty)
June 19, 1996 (Directed Portion of a Plan of Correction)
REASON: Condition level non-compliance resulting in immediate
jeopardy to the health and safety of the laboratory’s
patients.
STATUS: The laboratory has withdrawn from the CLIA program. CLIA
certification subsequently revoked.
James Redd, Director
Blanding Urgent Care Center
930 N. 400 W
Blanding, Utah 84511-3418
CLIA #46D0525318
[This listing contains additional information to the 1995 Laboratory
Registry entry for this laboratory.]
SANCTION: Suspension of approval to receive Medicare payment.
EFFECTIVE DATE: August 15, 1995
REASON: Improper referral of proficiency testing samples.
(5) A LIST OF LABORATORIES WHOSE ACCREDITATION
HAS BEEN WITHDRAWN OR REVOKED AND THE REASONS FOR THE WITHDRAWAL OR
REVOCATION:
Blount Memorial Hospital
1000 Lincoln Avenue
P.O. Box 1000
Oneonta, Alabama 35121
CLIA #01D0300297
SANCTION: Denial of Accreditation
EFFECTIVE DATE: January 23, 1997
REASON: Failure to respond to Proficiency Testing Exception
Summaries, excessive number of phase II deficiencies, and an
increasing number of recurring deficiencies.
STATUS: The laboratory did not file an appeal to the denial
decision.
Eugene M. Tachuk, M.D.
Eugene M. Tachuk, M.D. & Medical Corp.
1679 East Main Street, Suite 104
El Cajon, California 92021-5212
CLIA #05D0566311
SANCTION: Denial of Accreditation
EFFECTIVE DATE: April 11, 1997
REASON: Failure to adhere to accreditation organization imposed
required improvements. Deliberate disregard for accreditation
organization’s policy. CLIA certification subsequently
revoked.
Anthony Dean, M.D.
5575 Wilas Positas Blvd. #260
Pleasanton, California 94588
CLIA #05D0655976
SANCTION: Accreditation Withdrawn
EFFECTIVE DATE: February 4, 1997
REASON: Failure to complete the survey process by not responding to a
plan of correction for cited deficiencies.
Sang K. Lee, M.D.
5150 Graves Avenue, Suite 4
San Jose, California 95129-5004
CLIA #05D0608698
SANCTION: Denial of Accreditation
EFFECTIVE DATE: April 11, 1997
REASON: Failure to meet accreditation organization requirements.
The laboratory later changed CLIA certification to waived testing
only.
Vernon G. Allport, M.D.
Allergy Diagnostic Lab
854 Farmington Avenue
W. Hartford, Connecticut 06119-2181
CLIA #07D0094939
SANCTION: Denial of Accreditation
EFFECTIVE DATE: December 3, 1997
REASON: Failure to remit "Agreement to Plan of Required
Improvement" to accreditation organization.
Kenneth Blau, M.D.
Women’s Health Associates
27 Hospital Avenue, Suite 305
Danbury, Connecticut 06810-5954
CLIA #07D0100948
SANCTION: Denial of Accreditation
EFFECTIVE DATE: July 23, 1997
REASON: Failure to remit "Agreement to Plan of Required
Improvement" to accreditation organization.
Continental Medical Laboratory, Inc.
Central Laboratory Inc.
7515 West Oakland Park Boulevard
Lauderhill, Florida 33319
CLIA #10D0645378
SANCTION: Revocation of Accreditation
EFFECTIVE DATE: November 13, 1997
REASON: Failure to enroll in required proficiency testing after
repeated requests for compliance.
STATUS: The laboratory did not file an appeal to the denial
decision.
Arnold Markowitz, M.D., Director
2112 Cass Lake Road
Keego Harbor, Michigan 48320-1272
CLIA #23D0371712
SANCTION: Denial of Accreditation
EFFECTIVE DATE: September 27, 1997
REASON: Disregard of accreditation organization’s policies,
and failure to adhere to required improvements.
STATUS: Laboratory was subsequently surveyed by State agency.
Condition level non-compliance found. Further CLIA action pending.
Accumed Diagnostic Laboratory
187 Livington Avenue
New Brunswick, New Jersey 08901
CLIA #31D0125729
ACTION: Accreditation Withdrawal
EFFECTIVE DATE: June 19, 1997
REASON: Accreditation organization recommended withdrawal from the
accreditation program after numerous deficiencies were identified
at the initial inspection.
Andrew Blank, M.D.
Sunset Road Medical Associates
911 Sunset Road
Burlington, New Jersey 08016-2250
CLIA #31D0685438
SANCTION: Denial of Accreditation
EFFECTIVE DATE: April 11, 1997
REASON: Failure to remit "Agreement to Plan of Required
Improvement" to accreditation organization.
Robert DeMartin, M.D.
Laurel Avenue & Highway 35
Sea Girt, New Jersey 08750
CLIA #31D0709295
SANCTION: Denial of Accreditation
EFFECTIVE DATE: June 17, 1997
REASON: Failure to remit "Agreement to Plan of Required
Improvement" to accreditation organization.
Michael L. Greenberg, M.D.
Hematology Associates
5 East 98th Street 10th Floor
New York, New York 10029-6501
CLIA #33D0133300
SANCTION: Denial of Accreditation
EFFECTIVE DATE: December 3, 1997
REASON: Failure to remit "Agreement to Plan of Required
Improvement" to accreditation organization.
Jay B. Adlersberg, M.D.
220 E. 69th Street
New York, New York 10021-5737
CLIA #33D0671333
SANCTION: Denial of Accreditation
EFFECTIVE DATE: December 3, 1997
REASON: Failure to adhere to accreditation organization’s
required improvements.
Robert Weiner, M.D.
Family Medical Diagnostics
2381 Ralph Avenue
Brooklyn, New York 11234-5516
CLIA #33D0714652
SANCTION: Denial of Accreditation
EFFECTIVE DATE: May 19, 1997
REASON: Failure to remit "Agreement to Plan of Required
Improvement" to accreditation organization.
Ernest J. Simak, M.D., Director
Northern Ohio Medical Services, Inc.
6803 Mayfield Road, Suite 412
Mayfield Heights, Ohio 44124-2214
CLIA #36D0664985
SANCTION: Accreditation withdrawn
EFFECTIVE DATE: May 9, 1997
REASON: Disregard of accreditation organization’s standards
and policy. The laboratory failed to respond to repeated requests
for action to correct the deficiencies in accordance with the
laboratory’s post-survey Plan of Required Improvement.
STATUS: Laboratory currently has a certificate of waiver.
Dr. Jose Ramos Lebron Hospital
P.O. Box 1283
Fajardo, Puerto Rico 00738
CLIA #40D0658081
ACTION: Non-accreditation
EFFECTIVE DATE: September 4, 1997
REASON: Due to the accreditation organization’s policy of
accrediting the organization as a whole, the laboratory services
were also non-accredited because of problems with the hospital
services only. Laboratory met requirements for accreditation under
other circumstances.
Columbia Medical Center at Terrell
1551 Highway 34 South
Terrell, Texas 75160
CLIA #45D0478792
SANCTION: Denial of Accreditation
EFFECTIVE DATE: December 16, 1997
REASON: Failure to demonstrate compliance with Standards for
Laboratory Directorship and Quality Control.
STATUS: Laboratory appealed the denial decision. Denial was upheld.
Hermann Hospital/University of Texas
Houston Fertility Lab
6431 Fannin MSB R3 512
Houston, Texas 77030
CLIA #45D0699586
ACTION: Accreditation withdrawn
EFFECTIVE DATE: November 25, 1997
REASON: Accreditation organization recommended a focused
reinspection due to a high number of deficiencies at the initial
inspection. The laboratory withdrew from accreditation program.
Sara Apsley-Ambriz, CO
4127 E. South Cross, #4
San Antonio, Texas 78222
CLIA #45D0725916
ACTION: Denial of Accreditation
EFFECTIVE DATE: April 11, 1997
REASON: Failure to remit "Agreement to Plan of Required
Improvement" to accreditation organization after repeated
requests.
Algianon M. Jeffero, M.D.
2929 Calder Street, Suite 312
Beaumont, Texas 77702
CLIA #45D0873156
ACTION: Accreditation withdrawn
EFFECTIVE DATE : January 10, 1997
Centro de Salud Familiar La Fe
700 South Ochoa
El Paso, Texas 79901
CLIA #45D0880844
ACTION: Laboratory ceased testing all analytes
EFFECTIVE DATE: November 7, 1997
REASON: Laboratory ceased all testing due to repeated failure to
perform required proficiency testing.
STATUS: After successful performance of two cycles of proficiency
testing for all analytes provided, laboratory testing was
reinstated.
James S. Cook, M.D.
Health South Medical Blg. 1
7670 E. Parnam Road Suite 100
Richmond, Virginia 23294
CLIA #49D0227487
SANCTION: Denial of Accreditation
EFFECTIVE DATE: June 17, 1997
REASON: Failure to adhere to accreditation organization’s
required improvements.
Ulysses D, Agas, M.D.
Ulysses D. Agas, M.D., Inc.
557 Main Street
Logan, West Virginia 25601-3809
CLIA #51D0234840
SANCTION: Denial of Accreditation
EFFECTIVE DATE: July 23, 1997
REASON: Deliberate disregard for accreditation organization’s
policies and failure to adhere to accreditation
organization’s required improvements.
(6) ALL APPEALS AND HEARING DECISIONS:
Eugene M. Tachuk, M.D.
1679 Main Street, Suite A
El Cajon, California 92021
CLIA #05D0566311
SANCTION: Medicare cancellation and certificate
suspension/revocation.
REASON: On May 19, 1997 hearing filed to appeal determination to
suspend and revoke the laboratory’s CLIA certificate, cancel
Medicare payments, and assess a Civil Money Penalty of $9,150, due
to failure to correct deficiencies which resulted in the finding of
immediate jeopardy to patient health and safety. The hearing was
held on December 8, 1997 but was withdrawn on the second day of the
hearing. Administrative Law Judge dismissed the case, resulting in
sanctions becoming final.
Williams Bio Medical Laboratory
500 West Willow Street
Long Beach, California 90806
CLIA #05D0642670
SANCTION: Medicare cancellation.
REASON: Hearing request filed December 2, 1995. The Administrative
Law Judge upheld sanction determination in decision dated August 5,
1997. Cancellation of the laboratory’s approval to receive
Medicare payment for all laboratory services was previously
effectuated December 18, 1995.
Awad S. Anthony, M.D.
California Medical Associates Laboratory
2775 West Pico Boulevard
Los Angeles, California 90006
CLIA #05D0711870
SANCTION: Suspension of CLIA certification.
REASON: Condition level non-compliance resulting in immediate
jeopardy to the health and safety of patients was found during
initial survey. Hearing request filed May 14, 1996. The
Administrative Law Judge upheld sanction determination in decision
dated May 30, 1997.
STATUS: CLIA certification revoked.
Ward General Practice Clinic
10541 Jefferson Hwy.
River Ridge, Louisiana 70123
CLIA #19D0897371
SANCTION: Medicare cancellation
HEARING DECISION: The laboratory withdrew appeal September 26,
1997. Administrative Law Judge dismissed the case..
STATUS: CLIA certification revoked.
Ronald Hines, M.D., Director
Alexis J. Pittman, President
Allied Medical laboratory
G-8445 Saginaw
Grand Blanc, Michigan 48439
CLIA #23D0373014
SANCTION: Medicare cancellation and certificate
suspension/revocation
HEARING DECISION: Hearing request filed on September 20, 1996.
Hearing request dismissed by the Administrative Law Judge on
December 1, 1997 because of the laboratory’s failure to
participate in the hearing proceedings. Revocation of the
laboratory’s CLIA certificate became effective on December l,
1997.
Drs. Bacher, Isaacs, Tabbilos
25779 Kelly Road
Roseville, Michigan 48066-4973
CLIA #23D0700737
SANCTION: Revocation of certification and proposed revocation of
two other laboratories owned and/or operated by owners/operators of
laboratory.
HEARING DECISION: Hearing request filed April 30, 1997. Settlement
agreement negotiated. Hearing dismissed and laboratory recertified
for Provider Performed Microscopy Procedures (PPMP) testing,
effective June 23, 1997. The March 18, 1997 revocation was
rescinded, and the sanction in place on March 18, 1997 categorized
as a suspension. The laboratory agreed not to test outside of the
PPMP certification or seek certification for more comprehensive
testing for two years, beginning March 18, 1997. The proposed
certification revocations of the two other laboratories
owned/operated by the owner/operator of the laboratory were
rescinded.
Thyroid Specialty Laboratory
2900 Lemay Ferry Road, Suite 14
Saint Louis, Missouri 63125
CLIA #26D0710182
SANCTION: Medicare cancellation and revocation of certification
HEARING DECISION: Appeal filed June 28, 1996 and hearing held
February 13, 1997. Hearing decision issued October 21, 1997 upheld
revocation due to improper referral of proficiency testing to
another laboratory.
(7) A LIST OF LABORATORIES AGAINST WHICH HCFA
HAS BROUGHT SUIT UNDER SECTION 493.1846 AND THE REASONS FOR THOSE
ACTIONS:
None
(8) A LIST OF LABORATORIES THAT HAVE BEEN
EXCLUDED FROM PARTICIPATION IN MEDICARE OR MEDICAID AND THE REASONS
FOR THE EXCLUSION. (The following listing include settlements and are
based in part on information supplied by the HHS, Office of Inspector
General.)
R & M Laboratory
1990 SW First Street
Miami, Florida 33135
CLIA #10D0670960
Permanent, beginning July 29, 1997
Doctors Clinic Laboratory
4325 Alby Road
Alton, Illinois, 62002
CLIA #14D0715183 Provider #14847
Four years beginning August 18, 1997
Finlay Medical Laboratory
4912 Bergenline Avenue
West New York, New Jersey 07093
CLIA #31D0107778
Indefinite, beginning December 18, 1997
Specialty Clinical Laboratories
40 Paterson Street
P.O. Box 480
New Brunswick, New Jersey 08903
CLIA #31D0858841
Indefinite, beginning October 5, 1997
Williams Clinical Laboratory
404 11th Street SW
Birmingham, Alabama 35211
Provider #54265
10 years, beginning November 20, 1997
Yang Laboratories
7837 10th Avenue/South Street
St. Petersburg, Florida 33707
10 years, beginning April 3, 1997
Franklin Laboratories, Inc.,
4343 W. Flagler Street
Miami, Florida
50 years, beginning July 17, 1997
C & S Laboratory, Inc.,
15801 SW 137th Avenue
Miami, Florida 33177
Provider #L8565
10 years, beginning November 20, 1997
Advanced Medical Diagnostic
135 Front Street
Indianola, Mississippi 38751
Permanent, beginning September 9, 1997
Precise Medical Laboratories
40 Paterson Street
New Brunswick, New Jersey 08903
Five years, beginning October 6, 1997
SETTLEMENTS:
Smith-Kline Beecham Clinical Laboratories
1201 South Collegeville Rd.
Collegeville, Pennsylvania 19426
(multiple-locations)
SmithKline Beecham Clinical Laboratories, Inc. (SBCL) reached a
civil settlement in February of 1997 with the United States
government in the amount of $325 million to resolve the
government’s civil and administrative claims against the
company for the filing of false claims to Medicare and other
governmental payers during a seven-year period from 1989 to 1996.
SBCL is a national chain of clinical laboratories with its
headquarters in Collegeville, PA. This settlement was a result of
four years of investigation, first by an interagency task force in
San Diego, California, and since early 1994, by a task force of law
enforcement agencies in Philadelphia. The civil settlement
addressed the following types of alleged false or fraudulent
claims: add-on test, tests not performed, code jamming, kickbacks,
dialysis testing and additional indices. The settlement requires
SBCL to undertake and maintain a comprehensive compliance program
negotiated with the Office of the Inspector General (OIG) to ensure
that the complained of practices, or other false claims, do not
recur. OIG will monitor compliance. This civil settlement resolves
claims filed by private persons, known as relators, who brought
suit under the False Claims Act against SBCL. .
Physician Clinical Laboratories
3301 "C" Street, Suite 100E
Sacramento, California 95816
(19 locations)
Physician Clinical Laboratories (PCL), located in Sacramento,
California, agreed in October of 1997 to pay the United States $2
million to settle allegations filed in a civil suit that it had
over billed Medicare and CHAMPUS for blood and urine testing. PCL
did not admit in its settlement that it had engaged in any illegal
or improper conduct. This case was handled by the U.S.
Attorney’s Office for the Eastern District of California.
The company filed for bankruptcy, reorganized and is now doing
business as Bio-Cypher Laboratories.
9. CORRECTIONS OF ANY ERRONEOUS STATEMENTS OR
INFORMATION THAT APPEARED IN THE 1996 REGISTRY:
Category 1, Laboratory Convictions
Roche Biomedical
1447 York Ct.
Burlington, NC 27215-2230
Delete
Category 1, Individual Convictions
Graham-Massey Analytical Lab
a/k/a Massey Analytical Lab
a/k/a Massey Medical Lab
2212 Main Street
Bridgeport, CT 06606
CLIA #07D0686807
Correct to read:
Massey Analytical Labs., Inc.
2212/2214 Main Street
Bridgeport, CT 06606
CLIA #07D0686807
EFFECTIVE DATE: August 3, 1996
Correct to read:
EFFECTIVE DATE: August 13, 1996
Delete
last sentence of explanation under "REASON:".
10. OTHER ACTIONS
This section includes other specific information that may be useful in
evaluating the performance of laboratories, as specified in 493 CFR
1850(a). It also includes information provided by CLIA exempt states.
Bio-Mechanics Clinic
20 South Main
Aberdeen, Idaho 83210
CLIA #13D0922898
ACTION: Withdrawal from CLIA certification when informed that their
testing was high complexity and the naturopaths involved did not
qualify as clinical consultants.
EFFECTIVE DATE: June 3, 1997
Natural Health Center
3249 Indian Springs Road
American Falls, Idaho 83211-5507
CLIA #13D0927129
ACTION: Withdrawal from CLIA certification when informed that their
testing was high complexity and the naturopaths involved did not
qualify as clinical consultants.
EFFECTIVE DATE: August 26, 1997
Bio-Logix
810 North Henry #230
Post Falls, Idaho 83854
CLIA #13D0927135
ACTION: Lab withdrawal from CLIA certification when informed that
their testing was high complexity and the naturopaths involved did
not qualify as clinical consultants.
EFFECTIVE DATE: June 3, 1997
Care Corner Laboratory
1151 May Street
Hood River, Oregon 97031-1526
CLIA #38D0622007
ACTION: Voluntary withdrawal of the specialty of hematology due to
unacceptable proficiency testing on one test. Laboratory licensure
downgraded to Provider Performed Microscopy Procedures level of
complexity.
EFFECTIVE DATE: February 28, 1997
David Spiro, M.D., Director
Coastal Pediatrics Association
775 SW 9th Annex A
Newport, Oregon 97365-4850
CLIA #38D0626212
ACTION: Voluntary downgrade from high to moderate complexity
testing level of licensure because of condition equivalent
deficiencies in quality control and proficiency test performance in
the specialty of microbiology.
EFFECTIVE DATE: November 1997
Virginia Shepard, M.D., Director
Yamhill County Public Health
412 North Ford Street
Meminnville, Oregon 97128
CLIA #38D0662712
ACTION: Voluntary downgrade from moderate to Provider Performed
Microscopy Procedures complexity testing level of licensure because
of condition equivalent deficiency for failure to meet director
qualifications.
EFFECTIVE DATE: December 1997
Steven Wells, M.D., Director
Klamath County Health Service
403 Pine Street
Klamath Falls, Oregon 97601-6035
CLIA #38D0896636
ACTION: Voluntary downgrade from moderate to waived complexity
testing level of licensure based on condition equivalent
deficiencies for failure to meet director qualification.
EFFECTIVE DATE: September 1997
Diagnos-Techs
6620 South 192nd Place #J104
Kent, Washington 98032-2102
CLIA #50D0630141
ACTION: Laboratory corrected condition equivalent deficiencies in
quality assurance, quality control and management practices.
EFFECTIVE DATE: August 5, 1997
STATUS: Verified date of compliance - October 20, 1997
Eugene Schneider, Director
Meridian Valley Clinical Laboratory
515 West Harrison Street
Kent, Washington, 98032
CLIA #50D0630590
ACTION: Discontinued serum magnesium testing based on proficiency
testing performance.
EFFECTIVE DATE: August 15, 1997
Robert L. & Laura C. Perry, D.O
12610 Des Moines Memorial Drive
Seattle, Washington 98168-2270
CLIA #50D0633420
ACTION: Discontinued automated differentials testing based on
proficiency testing performance.
EFFECTIVE DATE: December 21, 1997
Doctors Clinic/Central Pediatrics
9615 Levin Road, NW #101
Silverdale, Washington 98383-9406
CLIA #50D0860394
ACTION: Discontinued automated differentials testing based on
proficiency testing performance.
EFFECTIVE DATE: May 7, 1997
Last Modified on Thursday, September 16, 2004
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