LABORATORY REGISTRY
1996
The Laboratory Registry is a list and status of laboratories that have failed to comply with the Clinical Laboratory Improvement Amendments (CLIA) requirements during the previous calendar year making it necessary for the Health Care Financing Administration (HCFA) to take an adverse action against them. These adverse actions may include certificate revocation (cessation of testing), certificate suspension (temporary cessation of testing), certificate limitation (cessation of testing in a particular laboratory specialty, such as hematology), termination and suspension of Medicare payments and directed plans of correction.
The Laboratory Registry also contains the names of laboratories that have been convicted under Federal of State laws relating to fraud and abuse, false billing, or kickbacks, as well as any persons who have been convicted of violating CLIA requirements. Any laboratory against which HCFA has brought suit will appear on the registry, as will any appeals and hearing decisions. Civil settlements reached with clinical laboratories are also noted.
Note:The Office of Inspector General (OIG), Health and Human Services, imposes exclusions and sanctions on laboratories based on authority contained in sections 1128 and 1156 of the Social Security Act. The complete OIG listing is available via the Internet at: www.sbaonline.sba.gov/ignet/internal/hhs/invlist.html.
To help you navigate, we have listed the main headings of the 1996 Laboratory Registry below:
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.)
3.PERSONS WHO HAVE BEEN CONVICTED OF VIOLATING CLIA REQUIREMENTS, AS SPECIFIED IN SECTION 353 (1) OF THE PUBLIC HEALTH SERVICE ACT, TOGETHER WITH THE CIRCUMSTANCES OF EACH CASE AND PENALTIES IMPOSED.
4.LABORATORIES ON WHICH ALTERNATIVE SANCTIONS HAVE BEEN IMPOSED, SHOWING: (I) effective date of sanction; (ii) reason for imposing them; (iii) corrective action taken by laboratory; and (iv) if laboratory has achieved compliance, the verified date of compliance.
6. APPEALS AND HEARING DECISIONS
Contacts:
Sheila Ward, E-mail, sward@cms.hhs.gov;
Jim Cometa, E-mail: jcometa@cms.hhs.gov
1996 LABORATORY REGISTRY
(as required by Section 353(n) of the Public Health Service Act)
Activity January 1, 1996 through December 31, 1996
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 listing is based in part on information supplied by HHS, Office of Inspector General.)
Laboratory Convictions
Eastern Laboratories, Inc.
95 Seaview Boulevard
Port Washington, NY 11050
[Listing supplied by State of New York]
SANCTION: Convicted under state laws related to fraud and ordered to pay restitution of $1,464,556.
EFFECTIVE DATE: February 16, 1996
REASON: False billings to Medicaid.
STATUS: Laboratory no longer in operation.
Balorac Inc.
200 Crescent Ct, #1500
Dallas, TX 75201
SANCTION: Fraud conviction.
EFFECTIVE: February 12, 1996
REASON:Convicted of a crime related to the delivery of an item or service under the Medicare program.
STATUS:Excluded form Medicare and state health care programs for a minimum period of 5 years.
Allied Clinical Laboratories*
San Diego Regional Laboratory
2970 5th Ave.
San Diego, CA 92103
SANCTION: Medicare fraud conviction.
EFFECTIVE DATE: November 21, 1996
REASON: Filing false claims.
Damon Clinical Laboratories, Inc.
(Acquired by Corning, Inc., in August, 1993)
Needham Heights, MA 02194
SANCTION: Medicare fraud conviction.
EFFECTIVE DATE:October 10, 1996
REASON: Filing false claims
STATUS:Permanent exclusion from Medicare and all federal and state health care programs.
* This is a corrected listing. The previous entry listing
Roche Biomedical was incorrect and erroneously reported to
HCFA.
Individual Convictions
Vernon Pugh
Advanced Medical Diagnostic, Inc.
1486 Canal Avenue
Greenville, MS 38701
SANCTION: Medicare fraud conviction.
EFFECTIVE DATE: July 1, 1996
REASON: Filing false claims.
Charles M. Parrot, M.D.
Nameaug Medical Centers
21 Montauk Avenue
New London, CT 06320
CLIA No. 07D0095335
SANCTION: Indicted on 185 counts of Medicare fraud.
EFFECTIVE DATE:October 29, 1996
REASON:Guilty plea to charges of submitting false claims.
STATUS: An on-site visit to the laboratory on September 9, 1996 confirmed closure and the laboratory was terminated from the CLIA program.
Massey Analytical Labs, Inc.
2212/2214 Main Street
Bridgeport, CT 06606
(This is a corrected entry.)
SANCTION:Exclusion from Medicare and state health care programs for a minimum period of 5 years.
EFFECTIVE DATE:August 13, 1996
REASON:Charged in Boston Municipal Court with four counts of Welfare fraud; arraigned June 30, 1995, found guilty and ordered to pay $15,000 in restitution, $2,000 in fines, $500 in surfines, and $30 victim/witness fee. Lab also entered into a civil settlement agreement with the Attorney General’s (AG) office and the Division of Medical Assistance (DMA), paying $82,470 to the DMA, returned its Medicaid provider number, permanently resigned its provider status and agreed to never apply for provider status with the DMA.
Fred L. Reed, Jr., M.D.
dba One Stop Medical Clinic
109 Hood Street
Lake Providence, LA 71254
CLIA No. 19D0705719
SANCTION:Fraud conviction.
EFFECTIVE DATE:June 6, 1996
REASON:Convicted of seven counts of Medicaid fraud relating to laboratory tests and office visits.
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.)
Angela Y. Ross-Johnson, M.D.
105 West Dublin Drive, Suite A
Madison, AL 35758
CLIA No. 01D0708360
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, and revocation of CLIA certificate.
EFFECTIVE DATE:November 5, 1996 (Medicare cancellation)
December 30, 1996 (Revocation)
REASON: No response to request for a plan of correction for non-compliances. No response received to the revocation sanction letter.
Jon Eylands, M.D., Director
Bullhead Community Hospital
Bullhead City, AZ 86442-7924
CLIA No. 03D0534417
SANCTION: Limitation of certificate in the specialty of cytology.
EFFECTIVE DATE: November 18, 1996
REASON: Immediate and serious threat to the health and safety of patients found during State Agency survey in response to a complaint. The survey found the laboratory out of compliance with several CLIA conditions.
George W. Ma, M.D.
711 West College Street, Suite 210
Los Angeles, CA 90012
CLIA No. 05D0541216
SANCTION:Revocation of CLIA certificate.
EFFECTIVE DATE: February 2, 1996
REASON:Failure to submit plan of correction for non-compliance.
Victor A. Kevorkian, M.D.
14111 Van Ness Avenue
Gardena, CA 90249
CLIA No. 05D0547816
SANCTION: Revocation of CLIA certificate.
EFFECTIVE DATE:February 16, 1996
REASON:Failure to submit an acceptable plan of correction for non-compliance.
Krishna Manvi, M.D. &
Parvataneni Arun, M.D., Inc.
2777 Pacific Avenue #D
Long Beach, CA 90806
CLIA No. 05D0554235
SANCTION: Revocation of CLIA certificate.
EFFECTIVE DATE: February 14, 1996
REASON: Failure to submit plan of correction for non-compliance.
Charles J. Jaffe, M.D.
dba Allergy & Immunology Medical Group
2067 West Vista Way, Suite 140
Vista, CA 92083
CLIA No. 05D0568925
SANCTION:Revocation of CLIA certificate.
EFFECTIVE DATE:February 8, 1996
REASON:Failure to submit plan of correction for non-compliance.
Joanne M. Benzor, M.D., Director
dba Family Medical Clinic of Perris
2055 N. Perris Boulevard, Suite E4
Perris, CA92571
CLIA No. 05D0573935
SANCTION:Revocation of CLIA certificate.
EFFECTIVE DATE: February 10, 1996
REASON: Failure to submit plan of correction for non-compliance.
Watson Medical Laboratories, Inc.
4835 N. Hallmark Parkway
San Bernardino, CA 92407
CLIA No. 05D0575026
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate. Proposed revocation pending hearing decision.
EFFECTIVE DATE:September 16, 1996 (Medicare cancellation/CLIA suspension)
November 15, 1996 (Proposed revocation)
REASON:Immediate and serious threat to the health and safety of patients found during State Agency survey in response to a complaint. The survey found the laboratory out of compliance with ten CLIA Conditions.
STATUS: Revocation hearing pending.
Roy I. Sugasawara, M.D.
dba Channel Islands Urology
2438 N. Ponderosa Drive, Suite C217
Camarillo, CA 93010
CLIA No. 05D0583360
SANCTION: Revocation of CLIA certificate.
EFFECTIVE DATE:February 10, 1996
REASON:Failure to submit an acceptable plan of correction for non-compliance.
Ochsner Cavins Urological Medical Group, Inc.
504 W. Pueblo #102
Santa Barbara, CA 93105
CLIA No. 05D0584720
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate.
Revocation of CLIA certificate.
EFFECTIVE DATE: January 1, 1996 (Medicare cancellation/CLIA suspension.)
February 15, 1996 (Revocation)
REASON: Failure to submit plan of correction for non-compliance.
Theodore R. Johnstone, M.D.
dba Primary Care Medical Group
509 South I Street, Suite A
Madera, CA 93637
CLIA No. 05D0588599
SANCTION: Revocation of CLIA certificate.
EFFECTIVE DATE:October 23, 1996
REASON: Improper referral of proficiency testing to another laboratory. Hearing held October 25, 1995 and in decision dated October 9, 1996, Administrative Law Judge upheld HCFA's determination to revoke CLIA certificate.
Doctors on Duty
1137 N. Main Street
Salinas, CA 93906
CLIA No. 05D0590338
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate.
EFFECTIVE DATE:March 19, 1996 (Medicare cancellation)
November 15, 1996 (Suspension)
REASON:Due to the revocation effective February 10, 1996 of Doctors on Duty, Santa Cruz, California. CLIA regulations prohibit the owner or operator with a revoked CLIA certificate to own, operate, or direct another laboratory for a period of two years from the date of revocation. The Doctors on Duty chain was owned by Robert D. Morris, M.D.
STATUS:Suspension was effectuated November 15, 1996 and lifted November 18, 1996 when laboratory changed ownership. Medicare cancellation lifted November 18, 1996.
Doctors on Duty Medical Clinic
389 Lighthouse Avenue
Monterey, CA 93940
CLIA No. 05D0590710
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate.
EFFECTIVE DATE:March 19, 1996 (Medicare cancellation)
November 15, 1996 (Suspension)
REASON:Due to the revocation effective February 10, 1996 of Doctors on Duty, Santa Cruz, California. CLIA regulations prohibit the owner or operator with a revoked CLIA certificate to own, operate or direct another laboratory for a period of two years from the date of revocation. The Doctors on Duty chain was owned by Robert D. Morris, M.D.
STATUS: Suspension was effectuated November 15, 1996 and lifted November 18, 1996 when laboratory changed ownership. Medicare cancellation lifted November 18, 1996.
Richard L. Keefe. M.D.
20396 Town Center Lane
Cupertino, CA 95014
CLIA No. 05D0605489
SANCTION:Revocation of CLIA certificate.
EFFECTIVE DATE: February 14, 1996
REASON:Failure to submit plan of correction for non-compliance.
Doctors on Duty Medical Clinic
615 Ocean Street
Santa Cruz, CA 95060
CLIA No. 05D0606591
SANCTION:Revocation of CLIA certificate.
EFFECTIVE DATE:February 10, 1996
REASON:Failure to submit plan of correction for survey which found laboratory to be out of compliance with three CLIA conditions.
Doctors on Duty
40 Penny Lane
Watsonville, CA 95076
CLIA No. 05D0607075
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate.
EFFECTIVE DATE: March 19, 1996 (Medicare cancellation)
November 15, 1996 (Suspension)
REASON: Due to the revocation effective February 10, 1996 of Doctors on Duty, Santa Cruz, California. CLIA regulations prohibit the owner or operator with a revoked CLIA certificate to own, operate or direct another laboratory for a period of two years from the date of revocation. The Doctors on Duty chain was owned by Robert D. Morris, M.D.
STATUS: Suspension was effectuated November 15, 1996 and lifted November 18, 1996 when laboratory changed ownership. Medicare cancellation lifted November 18, 1996.
Carliss R. Shelton, M.D.
Williams Bio Medical Laboratory
500 West Willow Street
Long Beach, CA 90806
CLIA No. 05D0642670
SANCTION: Revocation of CLIA certificate.
EFFECTIVE DATE:March 21, 1996
REASON:Non-payment of fees for compliance survey.
STATUS:Pending hearing on prior revocation due to deficiencies uncorrected 12 months after State Agency survey of August 1994.
Forrest O. Beaty, M.D.
dba Call Doctor/North Bay
7750 Martinelli Road
Forestville, CA 95436
CLIA No. 05D0669124
SANCTION: Revocation of CLIA certificate.
EFFECTIVE DATE:February 2, 1996
REASON: Failure to submit plan of correction for non-compliance
F. Jack Warner, M.D.
1023 E. Chapman Avenue
Fullerton, CA 92631
CLIA No. 05D0674379
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate.
EFFECTIVE DATE:May 5, 1996 - July 2, 1996
REASON:Failure to submit an acceptable plan ofcorrection for non-compliance. Acceptable plan was subsequently received and sanctions lifted July 3, 1996.
Celia Englander, M.D.
2222 Santa Monica Boulevard #405
Santa Monica, CA 90404
CLIA No. 05D0692166
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services, and revocation of CLIA certificate.
EFFECTIVE DATE: April 29, 1996 (Medicare cancellation)
June 6, 1996 (Revocation)
REASON:Failure to pay for compliance survey fee.
Paul L. Gottlieb, M.D.
6403 Coyle Avenue, Suite 280
Carmichael, CA 95608
CLIA No. 05D0693945
SANCTION:Revocation of CLIA certificate.
EFFECTIVE DATE: February 11, 1996
REASON:Failure to submit plan of correction for non-compliance
H.G. Greg Rainwater, M.D.
dba Fresno Urological Medical Group, Inc.
6191 North Fresno Street #101
Fresno, CA 93710
CLIA No. 05D0700464
SANCTION: Revocation of CLIA certificate.
EFFECTIVE DATE: April 30, 1996
REASON:Improper referral of proficiency testing samples.
Awad S. Anthony, M.D.
dba California Medical Associates Laboratory
2775 West Pico Boulevard
Los Angeles, CA 90006
CLIA No. 05D0711870
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, and suspension of CLIA certificate.
EFFECTIVE DATE:April 1, 1996 (Medicare cancellation)
May 16, 1996 (Suspension)
REASON:Failure to correct deficiencies resulting from State Agency follow-up survey which found laboratory to be out of compliance with three CLIA Conditions. Immediate and serious condition found during initial survey.
STATUS:Hearing request filed May 14, 1996.
Mitchell A. Pokrassa, M.D.
321 North Larchmont Boulevard #617
Los Angeles, CA 90004
CLIA No. 05D0713231
SANCTION: Revocation of CLIA certificate.
EFFECTIVE DATE: February 2, 1996
REASON:Failure to submit plan of correction for non-compliance.
Feliciano Rios, M.D.
1079-C Third Avenue
Chula Vista, CA 91911
CLIA No. 05D0717374
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services, suspension and proposed revocation of CLIA certificate.
EFFECTIVE DATE: January 1, 1996 - April 22, 1996
REASON: Failure to submit an acceptable plan of correction for non-compliance.
STATUS:Hearing filed February 14, 1996. Laboratory subsequently submitted evidence of correction and sanctions lifted effective April 23, 1996.
Bernard D. Gelled, M.D.
dba Allergy & Clinical Immunology Medical Group, Inc.
1301 20th Street, Suite 220
Santa Monica, CA 90404
CLIA No. 05D0861458
SANCTION:Revocation of CLIA certificate.
EFFECTIVE DATE:February 2, 1996
REASON: Failure to submit plan of correction for non-compliance.
Randall V. Rickets, D.O.
26302 La Paz Road, Suite 101
Mission Viejo, CA 92691
CLIA No. 05D0862791
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services, and suspension of CLIA certificate
EFFECTIVE DATE:January 1, 1996 - June 19, 1996
REASON:Failure to submit plan of correction for non-compliance. Acceptable plan of correction was subsequently submitted and sanctions lifted effective June 20, 1996.
Mallinckrodt Medical, Inc.
1145 West 6th Street
Los Angeles, CA 90017-1828
CLIA No. 05D0863186
SANCTION:Revocation of CLIA certificate.
EFFECTIVE DATE: February 2, 1996
REASON: Failure to submit plan of correction for non-compliance.
David C. Seltzer, M.D.
18399 Ventura Boulevard #241
Tarzana, CA 91356
CLIA No. 05D0865398
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services, and suspension of CLIA certificate.
Revocation of CLIA certificate.
EFFECTIVE DATE:January 1, 1996 (Medicare cancellation and suspension)
February 15, 1996 (Revocation)
REASON: Failure to submit plan of correction for non-compliance.
Donald E. Elvander, M.D.
1800 Sullivan Avenue, Suite 106
Daly City, CA 94015
CLIA No. 05D0868879
SANCTION:Revocation of CLIA certificate.
EFFECTIVE DATE:February 2, 1996
REASON:Failure to submit plan of correction for non-compliance.
Doctors on Duty
223 Mt. Hermon Road
Scotts Valley, CA 95066
CLIA No. 05D0871350
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, and suspension of CLIA certificate.
EFFECTIVE DATE:March 19, 1996 (Medicare cancellation)
November 15, 1996 (Suspension)
REASON:Due to the revocation effective February 10, 1996 of Doctors on Duty, Santa Cruz, California. CLIA regulations prohibit the owner, operator with a revoked CLIA certificate to own or operate or direct another laboratory for a period of two years from the date of revocation. The Doctors on Duty chain was owned by Robert D. Morris, M.D.
STATUS:Suspension was effectuated November 15, 1996 and lifted November 18, 1996 when laboratory changed ownership. Medicare cancellation lifted November 18, 1996.
Doctors on Duty
1910 N. Capitol Avenue
San Jose, CA 95132
CLIA No. 05D0871367
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services, and suspension of CLIA certificate.
EFFECTIVE DATE:March 19, 1996 (Medicare cancellation)
November 15, 1996 (Suspension)
REASON:Due to the revocation effective February 10, 1996 of Doctors on Duty, Santa Cruz, California. CLIA regulations prohibit the owner or operator with a revoked CLIA certificate to own, operate or direct another laboratory for a period of two years from the date of revocation. The Doctors on Duty chain was owned by Robert D. Morris, M.D.
STATUS:Suspension was effectuated November 15, 1996 and lifted November 18, 1996 when laboratory changed ownership. Medicare cancellation lifted November 18, 1996.
Doctors on Duty
1212 S. Main Street
Salinas, CA 93901
CLIA No. 05D0871370
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services, and suspension of CLIA certificate.
EFFECTIVE DATE:March 19, 1996 (Medicare cancellation)
November 15, 1996 (Suspension)
REASON:Due to the revocation effective February 10, 1996 of Doctors on Duty , Santa Cruz, California. CLIA regulations prohibit the owner or operator with arevoked CLIA certificate to own, operate or direct another laboratory for a period of two years from the date of revocation. The Doctors on Duty chain was owned by Robert D. Morris, M.D.
STATUS: Suspension was effectuated November 15, 1996 and lifted November 18, 1996 when laboratory changed ownership. Medicare cancellation lifted November 18, 1996.
Miriam Bahreini, M.D.
3500 Lomita Boulevard, Suite 203
Torrance, CA 90505
CLIA No. 05D0879741
SANCTION: Revocation of CLIA certificate.
EFFECTIVE DATE: February 10, 1996
REASON: Failure to submit an acceptable plan of correction for non-compliance.
Robert D. Morris, M.D., Director
Doctors on Duty
6800 Soquel Drive
Aptos, CA 95003
CLIA No. 05D0912015
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services, and revocation of CLIA certificate.
EFFECTIVE DATE:March 19, 1996 (Medicare cancellation)
November 15, 1996 (Revocation)
REASON:Due to the revocation effective February 10, 1996 of Doctors on Duty, Santa Cruz, California. CLIA regulations prohibit the owner or operator with a revoked CLIA certificate to own, operate or direct another laboratory for a period of 2 years from the date of revocation. The Doctors on Duty chain was owned by Robert D. Morris, M.D.
STATUS: Suspension was effectuated November 15, 1996 and lifted November 18, 1996 when laboratory changed ownership. Medicare cancellation lifted November 18, 1996.
Robert D. Morris, M.D., Director
Doctors on Duty
2260 N. Fremont Street
Monterey, CA 93940
CLIA No. 05D0912018
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, and revocation of CLIA certificate.
EFFECTIVE DATE:March 19, 1996 (Medicare cancellation)
November 15, 1996 (Revocation)
REASON:Due to the revocation effective February 10, 1996 of Doctors on Duty, Santa Cruz, California. CLIA regulations prohibit the owner or operator with a revoked CLIA certificate to own, operate or direct another laboratory for a period of two years from the date of revocation. The Doctors on Duty chain was owned by Robert D. Morris, M.D.
STATUS: Suspension was effectuated November 15, 1996 and lifted November 18, 1996 when laboratory changed ownership. Medicare cancellation lifted November 18, 1996.
Kevin J. Luck, Director
Complete Care Health Services, Inc
2768 S Wadsworth # D
Denver, CO 80227
CLIA No. 06D0902938
SANCTION: Cancellation of approval to receive Medicarepayment for all laboratory services and revocation of CLIA certificate.
EFFECTIVE DATE:December 5, 1995 (Cancellation of Medicare)
January 21, 1996 (Revocation)
REASON: Laboratory failed to submit a plan of correction for deficiencies cited during onsite survey. Two conditions were found out of compliance.
Marie Erickson
8309 NW 68th Street
Miami, FL 33166
CLIA No. 10D0698832
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services and revocation of CLIA certificate.
EFFECTIVE DATE: December 11, 1996 (Medicare cancellation)
January 29, 1997 (Revocation)
REASON: No response to request for a plan of correction for non-compliance found on April 22, 1996 survey. No response received to the revocation sanction letter.
Victor G. Polizos, M.D.
427 Moreland Avenue #400
Atlanta, GA 30307
CLIA No. 11D0901909
SANCTION: Cancellation of approval to receive Medicare payments for all laboratory services and revocation of CLIA certificate.
EFFECTIVE DATE: December 11, 1996 (Medicare cancellation)
February 4, 1997 (Revocation)
REASON:No response to request for a plan of correction for non-compliance found on June 28, 1996 survey. No response received to the revocation sanction letter.
Dr. David J. Benditzson, Director
55 East Washington, Suite 2903
Chicago, IL 60602 - 2205
CLIA No. 14D0422716
SANCTION:Cancellation of Medicare payment, suspension of CLIA certificate and revocation of CLIA certificate.
EFFECTIVE DATE:November 23, 1995 (Cancellation of Medicare payment)
November 23, 1995 (Suspension of CLIA certificate)
January 8, 1996 (Revocation of CLIA certificate)
REASON:Failure to submit an acceptable plan of correction for seven standard level deficiencies found out of compliance during the initial certification survey. The deficiencies had been out of compliance for 12 months.
Martha A. Dickerson, RN, MS
Laboratory Director
Care Med Chicago
(New Name: The Visiting Nursing Association of Chicago)
322 South Green Street, #300
Chicago, IL 60607
CLIA No. 14D0423363
SANCTION:Cancellation of approval to receive Medicare payment for its laboratory services, suspension of CLIA certificate, and revocation of CLIA certificate.
EFFECTIVE DATE:October 22, 1996 (Cancellation of Medicare payment)
October 22, 1996 (Suspension of CLIA certification)
December 1, 1996 (Revocation of CLIA certificate)
REASON:Laboratory was found out of compliance with five condition level requirements during the initial certification survey. Laboratory director, who also served as technical consultant, did not meet the qualification requirements for either position. The deficiencies substantially limited the laboratory’s capacity to ensure accurate and reliable test results. Laboratory failed to submit a plan of correction.
Dr. Pierangelo Taschini & Dr. Elizabeth Alenghat,
Directors
Doctors Hospital of Hyde Park
5800 South Stony Island
Chicago, IL 60637
CLIA No. 14D0710677
SANCTION:Cancellation of approval to receive Medicare payment for its laboratory services.
EFFECTIVE DATE:April 3, 1996 - June 11, 1996 (Cancellation of approval to receive Medicare payment for its laboratory services)
REASON:Repeat condition level noncompliance was found during three complaint surveys and two follow-up surveys. The deficiencies substantially limited the laboratory’s capacity to ensure accurate and reliable test results.
STATUS: The laboratory was found in compliance during the follow-up survey.
Dr. Thomas E. Dolan, Director
Gynecologic Oncology
8780 Golf Road, Suite 304
Niles, IL 60714
CLIA No. 14D0714612
SANCTION:Cancellation of approval to receive Medicare payment for its laboratory services.
EFFECTIVE DATE:May 5, 1996 - November 18, 1996
REASON:Two condition level requirements were found out of compliance during the initial certification survey. Laboratory was not timely in providing an acceptable plan of correction and correcting the deficiencies.
STATUS: Laboratory was found in compliance during follow-up survey of November 19, 1996.
Frederick Cahan, MD
Laboratory Director
1535 Lake Cook Road, Suite 603
Northbrook, IL 60062
CLIA No. 14D0721369
SANCTION:Cancellation of Medicare payment for its laboratory services.
EFFECTIVE DATE:October 8, 1996 - November 29, 1996 (Cancellation of Medicare payment)
REASON:Laboratory failed to submit an acceptable plan of correction for condition level requirements found out of compliance during the initial certification survey.
STATUS: Revised plan of correction, and supporting documentation to confirm correction of deficiencies, received and found acceptable on November 30, 1996.
Clarence E. Ward, Director
Ward General Practice Clinic
3221 Canal Street
New Orleans, LA 70119
CLIA No. 19D0459072
SANCTION: Cancellation of approval for Medicare payments for all laboratory services, suspension of CLIA certificate, and revocation of CLIA certificate.
EFFECTIVE DATE:August 10, 1996 (Medicare cancellation/CLIA suspension)
December 27, 1996 (Revocation)
REASON: Immediate and serious threat to the health and safety of patients, non-compliance with nine CLIA conditions.
Frank T. Ruggins, Director
Quality Care
3501 Fifth Ave., Suite A
Lake Charles, LA 70605
CLIA No. 19D0461903
SANCTION: Cancellation of approval for Medicare payments for all laboratory services, and revocation of CLIA certificate
EFFECTIVE DATE:February 26, 1996 Medicare (cancellation)
April 2, 1996 (Revocation)
REASON:Immediate and serious threat to the health and safety of patients. The laboratory removed the immediate jeopardy on revisit but continued to have non-compliance.
Mario Belledonne, M.D.
Biolab Medical
121 Congressional Lane, #205
Rockville, MD 20852-1542
CLIA No. 21D0867040
SANCTION: Limitation of approval to receive Medicare payment for laboratory services (the limitation prohibits testing in the subspecialty of cytology).
Limitation of CLIA certificate.
EFFECTIVE DATE: December 31, 1996
REASON:Laboratory not in compliance with three CLIA conditions. The plan of correction was not acceptable.
William L. Wilson
(Mario Golle, Director)
Bio-Analytical Laboratories, Inc.
405 Frederick Road, Suite 158
Catonsville, MD 21228-4647
CLIA No. 21D0873119
SANCTION:Cancellation of approval to receive Medicare payment for laboratory services, suspension of CLIA certificate, and proposed revocation of CLIA certificate pending hearing decision.
EFFECTIVE DATE:November 28, 1996 (Medicare cancellation and CLIA suspension)
REASON: Previously-imposed sanction was violated. On July 5, 1995, laboratory's certificate was limited, prohibiting testing in specialty of Chemistry. Laboratory was paid by Medicaid for various chemistry procedures with dates of service after July 5, 1995.
STATUS: Proposed revocation pending hearing decision. Violation referred to the Regional Office ofInspector General. Laboratory required to reimburse Maryland Medical Assistance Program.
Ronald Hines, MD, Director
Alexis J. Pittman, President
Allied Medical Laboratory, Inc.
G-8445 South Saginaw
Grand Blanc, MI 48439
CLIA No. 23D0373014
SANCTION:Cancellation of approval to receive Medicare payment for its laboratory services, suspension of CLIA certificate, and proposed revocation of CLIA certificate pending hearing decision..
EFFECTIVE DATE:September 2, 1996 (Cancellation of Medicare payment and suspension of CLIA certificate)
REASON:Laboratory found out of compliance with standard level requirements for more than 12 months. In response to the regional office sanction letter, the laboratory submitted documentation alleging compliance. However, a follow-up survey found conditions level non-compliance. The deficiencies substantially limited the laboratory’s capacity to ensure accurate and reliable test results.
STATUS:Hearing request filed on October 8, 1996. Revocation pending hearing decision.
Dr. Pramod Raval, Director
Pramod Raval Physician's Office
24661 Coolidge
Oak Park, MI 48237
CLIA No. 23D0667207
SANCTION:Cancellation of approval to receive Medicare payment for its services, suspension of CLIA certificate, and revocation of CLIA certificate.
EFFECTIVE DATE:May 9, 1996 (Cancellation of approval to receiveMedicare payment for its services)
May 9, 1996 (Suspension of CLIA certificate)
July 8, 1996 (Revocation of CLIA certificate)
REASON:The laboratory was found out of compliance with six condition level requirements during the initial certification survey. The deficiencies substantially limited the laboratory’s capacity to ensure accurate and reliable test results. The laboratory failed to submit an acceptable plan of correction.
Bahram Khodadadeh, MD, Director
4400 Orchard Lake Road
West Bloomfield, MI 48323
CLIA No. 23D0678422
SANCTION:Cancellation of approval to receive Medicare payments, suspension of CLIA certificate, and revocation or CLIA certificate.
EFFECTIVE DATE:August 7, 1996 (Cancellation of approval to receive Medicare payment for laboratory services)
August 7, 1996 (Suspension of CLIA certificate)
September 16, 1996 (Revocation of CLIA certificate)
REASON:The laboratory was found out of compliance with five standard level requirements during the initial certification survey. The standards had been out of compliance for more than 12 months. Laboratory failed to submit a plan of correction.
Alok Shukla, MD, Director
24025 Greater Mack
St. Clair Shores, MI 48080-1484
CLIA No. 23D0885249
SANCTION:Cancellation of approval to receive Medicare payment for laboratory services, suspension of CLIA certificate, revocation of CLIA certificate.
EFFECTIVE DATE:February 9, 1996 (Cancellation of approval to receive Medicare payment for laboratory services)
February 9, 1996 (Suspension of CLIA certificate)
April 10, 1996 (Revocation of CLIA certificate)
REASON:Laboratory was found out of compliance with five condition level requirements during the initial certification survey. Laboratory failed to submit a plan of correction.
Thyroid Specialty Laboratory
2900 Lemay Ferry Road, Suite 114
St. Louis, MO 63125
CLIA No. 26D0710182
SANCTION: Cancellation of approval to receive Medicare and Medicaid payments for all services, suspension of CLIA certification and revocation of CLIA certificate pending hearing decision.
EFFECTIVE DATE: May 15, 1996 (Cancellation of approval to receive Medicare/Medicaid payment and suspension of CLIA certificate)
REASON: Improper referral of proficiency testing samples. Samples sent to another laboratory for analysis.
STATUS:Proposed revocation of CLIA certificate pending hearing decision.
Algis A. Martell, M.D.
A Lady's Needs
3625 S. Mojave Road #14
Las Vegas, NV 89121
CLIA No. 29D0709312
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, and revocation of CLIA certificate.
EFFECTIVE DATE: March 5, 1996 (Medicare cancellation)
September 24, 1996 (Revocation)
REASON:Failure to correct condition-level deficiencies cited by the State Agency during a survey to investigate a complaint that laboratory was giving incorrect negative readings on urine pregnancy tests.
STATUS:Request for hearing filed February 28, 1996. Hearing subsequently dismissed September 24, 1996 due to laboratory's failure to pursue appeal.
Artemas J.W. Packard, M.D.
75 Main Street
Plaistow, NH 03865
CLIA No. 30D0087424
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services, and revocation of CLIA certificate.
EFFECTIVE DATE:August 9, 1996 (Medicare cancellation)
September 20, 1996 (Revocation)
REASON:Three CLIA conditions were found out of compliance during the State Health Department certification survey.
Bharati Penupatruni, M.D.
Laboratory Director
Medical Clinical Laboratory
373 Livingston Avenue
New Brunswick, NJ 08901
CLIA No. 31D0125763
SANCTION: Suspension of CLIA certificate.
EFFECTIVE DATE:July 31, 1996
REASON:Immediate and serious threat to the health and safety of the patients found during State Health Department survey conducted in January 1996. Laboratory was out of compliance with five condition level requirements. In addition, the State survey found that the laboratory routinely altered analytical data and reported fabricated test results.
Wilfred L. Anderson, MD
Laboratory Director
5 Severance Circle #818
Cleveland, OH 44118 - 1513
CLIA No. 36D0336888
SANCTION:Cancellation of approval to receive Medicare payment for its laboratory services, suspension of CLIA certificate, and proposed revocation CLIA certificate.
EFFECTIVE DATE:December 14, 1996 (Cancellation of Medicare payment)
December 14, 1996 (Suspension of CLIA certificate)
REASON:Laboratory was found out of compliance with condition level requirements during the initial certification survey. The deficiencies substantially limited the laboratory's capacity to ensure accurate and reliable test results. Laboratory failed to submit an acceptable plan of correction.
STATUS: Revocation pending hearing decision.
Willie L. Posey II, DO, Director
First Choice Medical Clinical Laboratory
RT 60 Devola Medical Clinic Building
Marietta, OH 45750
CLIA No. 36D0902626
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services.
EFFECTIVE DATE:December 26, 1995 - October 21, 1996
REASON: Laboratory failed to submit documentation to confirm its enrollment into a HCFA approved proficiency testing program.
STATUS: Proficiency testing enrollment effective on October 22, 1996.
Thomas A. Thomas & Louis Laverde
Girard Hematology Laboratory
1751 Squaw Creek Drive
(208 West Liberty Street - New Address)
Girard, OH 44420
CLIA No. 36D0906547
SANCTION: Cancellation of approval to receive Medicare payment for its laboratory services, suspension of CLIA certificate, and revocation of CLIA certificate.
EFFECTIVE DATE:July 3, 1996 (Cancellation of approval to receive payment for its laboratory services)
July 3, 1996 (Suspension of CLIA certificate)
August 12, 1996 (Revocation of CLIA certificate)
REASON: The laboratory was found out of compliance with two condition level requirements during the initial certification survey. The laboratory’s director did not meet the requirements for performing highcomplexity testing. The deficiencies substantially limited the laboratory’s capacity to ensure accurate and reliable test results. The laboratory failed to submit a plan of correction.
Robert E. Hunter, Director
Hunter Clinic
901 S.W. 33rd Street
Oklahoma City, OK 73109
CLIA No. 37D0470540
SANCTION: Cancellation of approval to receive Medicare payments for all laboratory services, and proposed revocation of CLIA certificate.
EFFECTIVE DATE:December 31, 1996 (Medicare cancellation)
REASON:Intentional improper referral of proficiency testing specimens to another laboratory.
STATUS:Revocation pending hearing decision.
Douglas S. Tsuchida, M.D.
4544 N. Hwy 6
Houston, TX 77084
CLIA No. 45D0493846
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services, suspension of CLIA certification and revocation of CLIA certificate.
EFFECTIVE DATE:March 7, 1996 (Medicare cancellation/CLIA suspension)
April 7, 1996 (Revocation)
REASON: Failure to correct standard level deficiencies within 12 months.
Warner B. Massey M.D., Pathology Services
119 E. Houston Street
Tyler, TX 75702
CLIA No. 45D0659703
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension of CLIA certification and proposed revocation of CLIA certificate.
EFFECTIVE DATE:June 11, 1996 (Medicare cancellation/CLIA suspension)
REASON:Immediate and serious threat to the health and safety of patients, non-compliance with four CLIA conditions.
STATUS:Revocation pending hearing decision.
L.R. Hsu, M.D. & S.Y. Turng, M.D.
315 South Cockrell Hill Road, Suite 100
Duncanville, TX 75116
CLIA No. 45D0691921
SANCTION:Cancellation of approval to receive Medicare payment for all laboratory services, suspension of CLIA certification and revocation of CLIA certificate.
EFFECTIVE DATE:February 23, 1996 (Medicare cancellation/CLIA suspension)
March 25, 1996 (Revocation)
REASON: Failure to correct standard level deficiencies within 12 months.
Professional Labs
1130 Pecan, Suite 2
McAllen, TX 78501
CLIA No. 45D0914232
SANCTION:Cancellation of approval to receive Medicare payment for all laboratories services, and suspension of CLIA certification.
EFFECTIVE DATE:May 22, 1996 (Medicare cancellation/CLIA suspension)
REASON: Immediate and serious threat to the health and safety of patients. Non-compliance with six CLIA conditions.
Parkview Medical Laboratories
1141 East 3900 SO #128A
Holladay, Utah 84124-1215
CLIA No. 46D0524667
SANCTION: Cancellation of approval to receive Medicare payment and revocation of CLIA certificate.
EFFECTIVE DATE:December 26, 1995 (Cancellation of Medicare payment)
February 11, 1996 (Revocation of CLIA certificate)
REASON:Laboratory failed to meet Laboratory Director requirements.
James Redd, Director
Blanding Urgent Care Center
930 N 400 W
Blanding, UT 84511-3418
CLIA No. 46D0525318
SANCTION:Cancellation of approval to receive Medicare payment and revocation of CLIA certificate.
EFFECTIVE DATE:September 30, 1996 (Medicare cancellation/CLIA revocation)
REASON: Improper referral of proficiency testing samples.
Ronald Burr, Director
Parowan Medical Clinic
450 East Clinic Way
Parowan, UT 84761
CLIA No. 46D0718140
SANCTION:Cancellation of approval to receive Medicare payments and revocation of CLIA certificate.
EFFECTIVE DATE:August 17, 1996 (Medicare cancellation/CLIA revocation)
REASON: Improper referral of proficiency testing specimens to another laboratory.
David W. Roycroft, M.D.
Northside Drive
Martinsville, VA 24112
CLIA No. 49D0231810
SANCTIONS:Cancellation of approved to receive Medicare payment for laboratory services, suspension of CLIA certificate, and proposed revocation of CLIA certificate.
EFFECTIVE DATE:September 20, 1996 (Medicare cancellation and CLIA suspension)
REASON:Laboratory not in compliance with CLIA conditions: Cytology, Laboratory Director, Laboratory Technical Supervisor and Quality Assurance. A plan of correction was not submitted.
STATUS:Revocation pending hearing decision.
Michael S. Creef, M.D.
South Norfolk Family Practice
1201 Jackson Street
Chesapeake, VA 23324-2307
CLIA No. 49D0895763
SANCTION: Cancellation of approval to receive Medicare payment for laboratory services, and limitation of CLIA certificate.
EFFECTIVE DATE:March 26, 1996 (Medicare cancellation)
April 17, 1996 (Limitation of certificate)
REASON:Laboratory not enrolled in proficiency testing program for bacteriology and general immunology. In addition, laboratory failed to submit plan of correction and other necessary documentation.
3.PERSONS WHO HAVE BEEN CONVICTED OF VIOLATING CLIA REQUIREMENTS, AS SPECIFIED IN SECTION 353 (1) OF THE PUBLIC HEALTH SERVICE ACT, TOGETHER WITH THE CIRCUMSTANCES OF EACH CASE AND PENALTIES IMPOSED.
4.LABORATORIES ON WHICH ALTERNATIVE SANCTIONS HAVE BEEN IMPOSED, SHOWING: (I) effective date of sanction; (ii) reason for imposing them; (iii) corrective action taken by laboratory; and (iv) if laboratory has achieved compliance, the verified date of compliance.
Dr. John Passmann, M.D.
Doctor’s Hospital of Hyde Park, Inc.
5800 South Stony Island
Chicago, IL 60637
CLIA No. 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 deficiencies from recurring over the course of three complaint surveys and two follow-up surveys. The recurring deficiencies impacted negatively upon the laboratory’s capacity to ensure accurate and reliable test results.
STATUS:The laboratory was found in compliance with the directed plan of correction during follow-up survey.
Warner B. Massey M.D., Pathology Services
119 E. Houston Street
Tyler, TX 75702
CLIA No. 45D0659703
SANCTION:Civil monetary penalty and directed portion of a plan of correction.
EFFECTIVE DATE: June 13, 1996 (civil monetary penalty)
July 1, 1996 (directed portion of a plan of correction)
REASON: Immediate and serious threat to health and safety of patients. Non-compliance with four CLIA conditions.
STATUS:The laboratory filed an appeal and a hearing is pending.
Professional Labs
1130 Pecan, Suite 2
McAllen, TX 78501
CLIA No. 45D0914232
SANCTION: Civil monetary penalty and 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: Immediate and serious threat to health and safety of patients due to non-compliance with six CLIA conditions.
STATUS:The laboratory has withdrawn from the CLIA program. (CLIA certificate subsequently revoked.)
James Redd, Director
Blanding Urgent Care Center
930 N 400 W
Blanding, UT 84511-3418
CLIA No. 46D0525318
SANCTION:Suspension of approval to receive Medicare payment.
EFFECTIVE DATE:August 15, 1995
REASON: Improper referral of proficiency testing samples.
(Note: This listing was inadvertently excluded from the 1995 Registry.)
5.LABORATORIES WHOSE ACCREDITATION HAS BEEN WITHDRAWN OR REVOKED AND THE REASONS FOR THE WITHDRAWAL OR REVOCATION.
Ketchikan General Hospital Laboratory
3100 Tongass Avenue
Ketchikan, AK 99901
CLIA No. 02D0641454
SANCTION: Denial of accreditation (College of American Pathologists)
EFFECTIVE DATE: November 8, 1996
REASON: Inability of the laboratory to provide adequate and timely corrective action to deficiencies noted at June 3, 1996 onsite inspection.
STATUS:Laboratory has reapplied for accreditation and re-inspection is pending.
Central Medical Laboratory
10554 Progress Way, Suite J
Cypress, CA 90630
CLIA No. 05D0664072
SANCTION:Revocation of accreditation (College of American Pathologists)
EFFECTIVE DATE: June 17, 1996
REASON:CAP non-compliance found during onsite inspection of cytopathology conducted June 3-4, 1996.
STATUS:Laboratory corrected deficiencies prior to HCFA imposition of alternative sanctions. Condition-level compliance verified during onsite visit of September 6, 1996.
Family Medicine Center Laboratory
Medical College of Georgia
1120 15th Street
Augusta, GA 90213
CLIA No. 11D0263314
SANCTION: Denial of accreditation (College of American Pathologists)
EFFECTIVE DATE:April 30, 1996
REASON:Failure to demonstrate appropriate corrective action to deficiencies noted at initial onsite inspection.
STATUS:Laboratory filed an appeal to the denial decision. The denial was upheld.
Respiratory Laboratory
Middlesex Hospital
775 Trapelo Road
Waltham, MA 02154
CLIA No. 22D0717994
SANCTION: Revocation of accreditation (College of American Pathologists)
EFFECTIVE DATE: July 19, 1996
REASON:Failure to demonstrate appropriate corrective action to deficiencies noted at focused reinspection on May 22, 1996.
Detroit Medical Center Clinical Laboratories
3750 Woodward, Suite 26
Detroit, MI 48201
CLIA No. 23D0369514
SANCTION: Denial of accreditation (College of American Pathologists)
EFFECTIVE DATE: April 30, 1996
REASON: Failure to demonstrate appropriate corrective action to the deficiencies noted at March 13, 1996 onsite inspection.
STATUS:Laboratory filed an appeal to the denial decision. The denial was upheld.
Algianon M. Jeffery, M.D.
2929 Calder Street, Suite 312
Beaumont, TX 77702
CLIA No. 45D0873156
SANCTION: Denial of accreditation (Commission on Office Laboratory Accreditation)
EFFECTIVE DATE: September 15, 1996
REASON: Failure to provide documentary evidence of enrollment in proficiency testing for Rapid Antigen Detection of Group A Streptocossus and Serum Human Chorionic Gonadotropin testing.
6. APPEALS AND HEARING DECISIONS
Primary Care Medical Group
509 South I Street Suite A
Madera, CA 93637
CLIA No. 05D0588599
SANCTION: Medicare cancellation and certificate revocation.
HEARING DECISION:The Departmental Appeals Board ruled on October 9, 1996 that the laboratory is subject to revocation of its CLIA certificate for a one-year minimum mandatory period, and to cancellation of Medicare payments for laboratory services due to intentional improper referral of proficiency testing samples to another laboratory.
Theodore R. Johnstone, M.D.
dba Primary Care Medical Group
509 South I Street, Suite A
Madera, CA 93637
CLIA No. 05D0588599
SANCTION: Medicare cancellation and certificate revocation.
HEARING DECISION:Appeal filed July 19, 1995 and hearing held October 25, 1995. Hearing decision issued October 9, 1996 upheld revocation due to improper referral of proficiency testing to another laboratory.
Williams Bio Medical Laboratory
500 West Willow Street
Long Beach, CA 90806
CLIA No. 05D0642670
SANCTION: Medicare cancellation and certificate revocation.
HEARING DECISION:Hearing request filed December 2, 1995 to appeal revocation of CLIA certificate and Medicare cancellation due to uncorrected deficiencies 12months after survey of August 4, 1994. HCFA moved to have the appeal dismissed as certification was subsequently revoked effective March 21, 1996 due to non-payment of fees, this latter separate and distinct sanction took effect without the laboratory filing an appeal. The administrative law judge (ALJ) did not grant dismissal, but did grant partial summary judgment to narrow the issue for hearing. Hearing date set. Laboratory has waived in-person hearing and has opted to have ALJ make decision based on briefs.
Feliciano R. Rios, M.D., Inc.
1079-C Third Avenue
Chula Vista, CA 91911
CLIA No. 05D0717374
SANCTION:Medicare cancellation and certificate suspension/revocation.
HEARING DECISION:Hearing filed February 14, 1996 to appeal revocation and suspension of CLIA certificate and cancellation of approval to receive Medicare payment due to failure to submit an acceptable plan of correction for non-compliance. Laboratory subsequently submitted credible evidence of correction. Based on this, HCFA rescinded revocation and on April 23, 1996 lifted suspension and Medicare cancellation which had taken effect on January 1, 1996.
Clarence E. Ward, Director
Ward General Practice Clinic
3221 Canal Street
New Orleans, LA 70119
CLIA No. 19D0459072
SANCTION:Medicare cancellation and certificate suspension/revocation.
HEARING DECISION:The Departmental Appeals Board on December 27,1996 sustained the decision of HCFA to impose sanctions. The board also directed that the laboratory’s certificate be revoked effective December 27, 1996.
Algis A. Martell, M.D.
A Lady's Needs
3625 S. Mojave Road #14
Las Vegas, NV 89121
CLIA No. 29D0709312
SANCTION:Medicare cancellation and certificate suspension/revocation.
HEARING DECISION:Request for hearing filed February 28, 1996 to appeal HCFA's determination to revoke CLIA certificate and cancel Medicare payments due to non-compliance. Hearing subsequently dismissed September 24, 1996 because lab failed to pursue appeal. Medicare cancellation took effect March 5, 1996 and CLIA revocation took effect September 24, 1996.
Center Clinical Laboratory
4900 Bergenline Avenue
Union City, NJ 07087
CLIA No. 31D0107410
SANCTION: Certificate suspension and revocation.
HEARING DECISION:Due to serious condition-level noncompliance posing immediate jeopardy to patient health and safety. Hearing filed and on February 15, 1996 an administrative law judge (ALJ) reversed HCFA on the basis that the sanctions were not authorized by law. No decision was made as to whether the reported deficiencies existed or posed danger to public health. HCFA appealed, and on July 31, 1995, the Departmental Appeals Board reversed and remanded the case to the ALJ for a decision on the substantive merits of the sanctions. On February 15,1996, the remanded decision was released, and the ALJ upheld condition-level deficiencies and the sanctions imposed. The laboratory did not file an appeal.
Blanding Urgent Care Center Laboratory
900 N 400W
Blanding, UT 84511-3418
CLIA No. 46D0525318
SANCTION:Medicare cancellation and certificate revocation
HEARING DECISION:The Departmental Appeals Board ruled on September 30, 1996 that the laboratory is subject to revocation of its CLIA certificate for a one-year minimum mandatory period, and to cancellation of Medicare payments for laboratory services due to intentional improper referral of proficiency testing samples to another laboratory.
7.LABORATORIES AGAINST WHICH HCFA HAS BROUGHT SUIT UNDER 42 C.F.R SECTION 493.1846 AND THE REASONS FOR THOSE ACTIONS.
8.LABORATORIES THAT HAVE BEEN EXCLUDED FROM PARTICIPATION IN THE MEDICARE AND MEDICAID PROGRAMS AND REASONS FOR THE EXCLUSION.
[The following listings include settlements and are based in part on information supplied by the HHS, Office of Inspector General.]
Balorac, Inc.
200 Crescent Ct #1500
Dallas, TX 75201
SANCTION:Excluded from Medicare and State health care programs for a minimum period of 5 years.
EFFECTIVE DATE:February 12, 1996
REASON:Convicted of a crime related to the delivery of an item or service under the Medicare or a state health care program.
Damon Clinical Laboratories, Inc.
(Acquired by Corning, Inc. in August 1993)
Needham Heights, MA 02194
SANCTION: Permanent exclusion from Medicare and all federal and state heath care programs.
EFFECTIVE DATE:October 10, 1996
REASON: Medicare fraud.
Charles M. Parrot, M.D.
Nameaug Medical Centers
21 Montauk Avenue
New London, CT 06320
CLIA No. 07D0095335
SANCTION: Medicare exclusion.
EFFECTIVE DATE:October 29, 1996
REASON: Submitting false claims.
Graham-Massey Analytical Labs, Inc.
a/k/a Massey Analytical Labs
a/k/a Massey Medical Labs
2214 Main Street
Bridgeport, CT 06606
CLIA No. 07D0686807
SANCTION: Excluded from Medicare and state health care programs for a minimum period of 5 years.
EFFECTIVE DATE:August 3, 1996
REASON:Convicted of a crime related to the delivery of an item or service under the Medicare or a state health care program.
Fred L. Reed, Jr., M.D.
dba One Stop Medical Clinic
109 Hood Street
Lake Providence, LA 71254
CLIA No. 19D0705719
SANCTION:Excluded from Medicare and state health care programs for a minimum period of 5 years.
EFFECTIVE DATE:June 6, 1996
REASON:Medicare fraud. The doctor was convicted of seven counts of fraud relating to laboratory tests and office visits.
Clinical Laboratory Settlements
Corning Clinical Laboratory, Inc.
a/k/a Metpath, Inc., Teterboro, N.J.
1350 I Street, NW
Washington, D.C. 02005-3505
SANCTION: Civil Settlement [$6.9 million].
EFFECTIVE DATE:September 19, 1996
REASON: Filing false claims.
Corning Clinical Laboratory, Inc.
[formerly known as Damon Laboratories, Needham, MA]
1350 I Street NW
Washington, D.C. 02005-3505
SANCTION: Civil Settlement [$119 million].
EFFECTIVE DATE:October 10, 1996
REASON: Filing false claims.
Labcorp of America
358 South Main Street
Burlington, NC 27215
SANCTION: Civil Settlement [$137 million].
EFFECTIVE DATE:November 21, 1996
REASON: Billed for services not ordered by a physician.
Smith-Kline Beecham Clinical Laboratories
1201 South Collegeville Rd.
Collegeville, PA 19426
SANCTION: Civil Settlement [$325 million].
EFFECTIVE DATE:September 27, 1996
REASON:Billed for services not ordered by a physician.
Spectra Laboratories
48848 Kao Road
Fremont, CA 94538
SANCTION: Civil Settlement [$10.1 million].
EFFECTIVE DATE:December 12, 1996
REASON: Providing services that were medically unnecessary.
MetWest, Inc.
[formerly known as Unilab Corp.]
18408 Oxnard Street
Tarzana, CA 91356
SANCTION: Civil Settlement [$4.1 million].
EFFECTIVE DATE: September 19, 1996
REASON: Improper claims submission.
Corning Clinical Laboratory, Inc.
[formerly known as Bioran Medical Laboratories, Inc., Cambridge, MA]
1350 I Street NW
Washington, D.C. 02005-3505
CLIA No. 22D0076229
SANCTION: Civil Settlement [$6.7 million].
EFFECTIVE DATE:February 20, 1996
REASON: Filing false claims.
