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LABORATORY REGISTRY 1998 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 the 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: (4) A list of laboratories on which alternative sanctions have been imposed, showing-- (i) the effective date of the sanctions; (ii) the reason for imposing them; (iii) any corrective action taken by the laboratory; (iv) if the laboratory has achieved compliance, the verified date of compliance. (6) All appeals and hearing decisions. 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 of 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
1998 LABORATORY REGISTRY (As required by Section 353(n) of the Public Health Service Act) Activity January 1,1998 through December 31, 1998 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 the Inspector General:
Express Lab and Center for Allergy
Laboratory convicted under Federal and/or State laws relating to fraud and abuse, false billings, or kickbacks.
Clin Path Laboratory
Laboratory convicted under Federal and/or State laws relating to fraud and abuse, false billing, or kickbacks.
Clinitec Laboratory
Laboratory convicted under Federal and/or State laws relating to fraud and abuse, false billing, or kickbacks.
Omar M. Amin, Ph.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services. Revocation of CLIA certificate. EFFECTIVE DATE: January 6, 1998 (Medicare cancellation) REASON: Cancellation of Medicare payments and revocation of CLIA certificate due to failure to correct standard-level deficiencies within 12 months of the survey date. STATUS: Revocation hearing pending.
Eugene A. Shaneyfelt, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services. Revocation of CLIA certificate. EFFECTIVE DATE: June 6, 1998 REASON: The owner of this facility was the laboratory director of another facility which had its CLIA certification 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.)
Dr. Carlton Newsome, Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: June 30, 1998 (Medicare cancellation/CLIA suspension) August 20, 1998 (Revocation) REASON: Immediate and serious threat to the health and safety of patients. Condition level non-compliance.
Eugene A. Shaneyfelt, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: February 14, 1998 (Medicare cancellation/CLIA suspension) April 11, 1998 (Revocation) REASON: Condition level non-compliance and intentional referral of its proficiency testing samples to another laboratory for analysis.
Sen B. Lai, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: November 20, 1998 (Medicare cancellation and suspension) REASON: Failure to respond to numerous request to provide specialty and test volume information necessary to determine continued eligibility for CLIA certification. STATUS: Revocation pending hearing.
Eugene M. Tachuk, M.D
SANCTION: Revocation of CLIA certificate. EFFECTIVE DATE: January 13, 1998 REASON: Immediate and serious threat to the health and safety of patients found during State Agency complaint survey of February 14, 1997. Condition level non-compliance.
Wynn M. Matsumura, D.D.S.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: January 6, 1998 (Medicare cancellation and suspension) March 7, 1998 (Revocation) REASON: Failure to provide evidence of method validation of a non-FDA approved test method (Oratec Bioscan System) within 12 months from the date of survey of November 5, 1996, during which the deficiency was cited.
Ahsan Qazi, M.D. Director
SANCTION: Revocation of CLIA certificate. EFFECTIVE DATE: January 28, 1998 REASON: Due to the revocation effective October 31, 1997 of Draw One Arterial Laboratory Inc., 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: Revocation pending hearing.
K. M. Ikram, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services. Revocation of CLIA certificate. EFFECTIVE DATE: December 5, 1998 (Medicare cancellation) January 19, 1999 (Revocation) REASON: Due to the revocation of CLIA certification effective August 22, 1998 of Med-Stat Clinical Laboratory Inc., Glendale, 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.
Soheil Hekmat, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for the specialty of Chemistry. Limitation of CLIA certificate for the specialty of Chemistry. EFFECTIVE DATE: March 31, 1998 (Medicare cancellation) May 15, 1998 (Limitation) REASON: Repeated failure in proficiency testing for chemistry analytes.
Edith Bernardo, Owner
SANCTION: Revocation of CLIA certificate. EFFECTIVE DATE: January 17, 1998 REASON: Condition level non-compliance causing immediate and serious threat to the health and safety of patients.
Excel Medical Diagnostics, Inc.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: April 23, 1998 (Medicare cancellation and suspension) May 13, 1998 (Revocation) REASON: Failure to comply with reasonable request for information necessary to determine the laboratory's continued compliance with CLIA requirements and failure to correct previous deficiencies.
K. M. Ikram, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: July 1, 1998 (Medicare cancellation and suspension) August 22, 1998 (Revocation) REASON: Immediate and serious threat to the health and safety of patients found during State Agency survey. Failure of owner to cooperate with the survey process.
Sol Teitelbaum, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: February 28, 1998(Medicare cancellation and suspension) April 14, 1998 (Revocation) REASON: Immediate and serious threat to the health and safety of patients found during State Agency survey.
Andrew T. Trapalis, M.D. Director
SANCTION: Revocation of CLIA certificate. EFFECTIVE DATE: January 16, 1998 REASON: Due to the revocation effective November 1, 1997 of Metro Medical Clinic, Rancho Cordova, 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. Both Metron Medical Group and Metro Medical Clinic owned by Andrew T. Trapalis, M.D.
Ahsan Quzi M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services. Revocation of CLIA certificate. EFFECTIVE DATE: July 11, 1998 (Medicare cancellation) REASON: Due to the revocation effective October 31, 1997 of Draw One Arterial Laboratory Inc., 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. STATUS: Revocation pending hearing.
Ahsan Qazi, M.D. Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services. Revocation of CLIA certificate. EFFECTIVE DATE: March 9, 1998 (Medicare cancellation) REASON: Due to the revocation effective October 31, 1997 of Draw One Arterial Laboratory Inc., 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. STATUS: Revocation pending hearing
Qazi Medical Group
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services. Revocation of CLIA certificate. EFFECTIVE DATE: March 9, 1998 (Medicare cancellation) REASON: Due to the revocation effective October 31, 1997 of Draw One Arterial Laboratory Inc., 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. STATUS: Revocation pending hearing
Lawrence C. Madsen, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: November 20, 1998 (Medicare cancellation and suspension) REASON: Failure to respond to numerous request to provide specialty and test volume information necessary to determine continued eligibility for CLIA certification. STATUS: Revocation pending hearing.
Rosendo Reyes, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payments for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: November 20, 1998 (Medicare cancellation and suspension) REASON: Failure to respond to numerous request to provide specialty and test volume information necessary to determine continued eligibility for CLIA certification. STATUS: Revocation pending hearing.
Andrew T. Trapalis, M.D., Director
SANCTION: Revocation of CLIA certificate. EFFECTIVE DATE: January 16, 1998 REASON: Due to the revocation effective November 1, 1997 of Metro Medical Clinic, Rancho Cordova, 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. Both Metron Medical Group and Metro Medical Clinic owned by Andrew T. Trapalis, M.D.
Panteleon De Jesus, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: December 31, 1998 (Medicare cancellation and suspension) REASON: A complaint survey completed November 12, 1998 found immediate and serious threat to the health and safety of patients. STATUS: Revocation pending hearing.
Keith G. Cook, M.D., and
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and revocation of CLIA certificate. EFFECTIVE DATE: November 28, 1998 REASON: Failure to submit a plan of correction for deficiencies cited during an onsite survey. STATUS: CLIA certificate revoked.
Abdul Rauf, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: September 11, 1998 REASON: Condition level non-compliance and failure to submit an acceptable plan of correction.
Peter R. Lewy, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all test in the bacteriology subspecialty area, and limitation of CLIA certificate in bacteriology subspecialty area. EFFECTIVE DATE: September 15, 1998 REASON: Failure to submit a plan of correction. STATUS: CLIA certificate expired because of failure to pay CLIA fees.
Ara M. Minasian, Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension, and revocation of CLIA certificate. EFFECTIVE DATE: December 20, 1997 (Medicare cancellation) December 20,1997 (Suspension) February 3, 1998 (Revocation) REASON: Failure to submit an acceptable plan of correction for condition level non-compliance. STATUS: Laboratory requested a hearing on February 3, 1998. A settlement agreement was negotiated: revocation of the laboratory's CLIA certificate and permanently closure following the two-year revocation period.
C. R. Carmichael, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: December 10, 1997 (Medicare) December 10, 1997 (Suspension) January 24, 1998 (Revocation) REASON: Failure to submit a plan of correction for noncompliance found during a previous recertification survey.
Woo J. Yoon, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: October 3, 1998 (Medicare cancellation), October 3, 1998 (Suspension) November 17, 1998 (Revocation) REASON: Condition level non-compliance and failure to provide information necessary to determine compliance.
Veena K. Gupta, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: October 17, 1998 - November 11, 1998 STATUS: Cancellation of Medicare payment and suspension of CLIA certificate were lifted on November 12, 1998 following receipt of evidence necessary to confirm compliance.
Clarence Ward, M.D.
SANCTION: Revocation of CLIA certificate. EFFECTIVE DATE: February 3, 1998 REASON: The owners of this facility were owners of another facility which had its certificate revoked on December 27, 1996. 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.
Pradeep Garg, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: September 5, 1998 (Medicare cancellation and suspension) October 20, 1998 (Revocation) REASON: Condition level non-compliance and failure to submit a plan of correction.
Alberto C. Seiguer, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: September 3, 1998 REASON: Failure to submit a plan of correction. STATUS: Revocation pending hearing.
Arnold Markowitz, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and proposed revocation of CLIA certificate. EFFECTIVE DATE: June 10, 1998 - July 7,1998 ( Medicare cancellation) REASON: Laboratory was denied accreditation organization. A complaint investigation survey found condition level non-compliance. STATUS: Laboratory submitted documentary evidence supporting correction of the noncompliance found. Proposed revocation rescinded.
Gurcharan L. Gagneja, Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and proposed revocation of CLIA certificate. EFFECTIVE DATE: September 2, 1998 (Medicare cancellation) REASON: Intentional referral of proficiency testing samples to another laboratory for analysis and unsuccessful participation in proficiency testing program. STATUS: Revocation pending hearing.
Lida H. Mattman, Ph.D., Director
SANCTION: Suspension and revocation of CLIA certificate. EFFECTIVE DATE: August 12, 1998 (Suspension of CLIA certificate) October 6, 1998 (Revocation of CLIA certificate) REASON: A complaint investigation survey found five condition level requirements out of compliance that caused immediate jeopardy to the health and safety of patients.
Khai Van Vo, M.D., Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: February 17, 1998 - June 21, 1998 (Medicare cancellation and suspension) REASON: Condition level non-compliance STATUS: Settlement agreement negotiated. The suspension and Medicare cancellation sanction lifted June 21, 1998. Certification status changed from certificate of compliance to certificate of waiver on June 22, 1998 and cannot be changed before February 16, 2000.
Bijoy Kundu, M.D.
SANCTION: Suspension of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: December 23, 1997 REASON: Condition level non-compliance STATUS: Compliance achieved January 14, 1998.
Saiyid S.H. Rizvi, Ph.D.
SANCTION: Suspension of approval to receive Medicare payments for all laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: January 15, 1998 REASON: Condition level non-compliance causing immediate jeopardy to the health and safety of the laboratory's patients. STATUS: Laboratory closed.
Randhir S. Sandhu, Ph.D.
SANCTION: Suspension of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: January 23, 1998 REASON: State Agency unable to verify correction of condition level non-compliance. STATUS: Hearing request filed.
Thirumalai V. Madhavan
SANCTION: Suspension of approval to receive Medicare payment for all services and suspension of CLIA certificate. EFFECTIVE DATE: December 11, 1998 REASON: Condition level non-compliance causing immediate and serious threat to the health and safety of the laboratory's patients. STATUS: Hearing request filed.
Rasik B. Gohil, Ph.D.
SANCTION: Suspension of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: December 29, 1998 REASON: Conditional level non-compliance causing immediate jeopardy to the health and safety of the laboratory's patients. STATUS: CLIA certificate revoked and approval to receive Medicare payments canceled.
Ann S Mercer, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: March 5, 1998 REASON: Conditional level non-compliance causing immediate jeopardy to the health and safety of the laboratory's patients.
Hugo Gruendel, M.D.
SANCTION: Suspension of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: July 9, 1998 REASON: Failed to submit an acceptable plan of correction. STATUS: Laboratory closed.
Eric J. Shefin, M.D.
SANCTION: Suspension or approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: September 9, 1998 REASON: Failure to submit an acceptable plan of correction. STATUS: Laboratory closed.
Hylton Lightman, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: May 26, 1998 REASON: Failure to submit an acceptable plan of correction.
Benifn R. Sales, Jr., M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: November 17, 1998 REASON: Failure to submit as acceptable plan of correction.
Mian N. Ahmad, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: July 3, 1998 REASON: Failure to submit an acceptable plan of correction.
Joseph Sherman, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: October 3, 1998 REASON: Failure to submit an acceptable plan of correction.
Robert Urbanek, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension and revocation of CLIA certificate. EFFECTIVE DATE: December 23, 1998 REASON: Failure to submit an acceptable plan of correction.
Kanu Patel, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension and revocation of CLIA certificate. EFFECTIVE DATE: May 20, 1998 REASON: Failure to submit an acceptable plan of correction.
Santo Basileo, M.D.
SANCTION: Cancellation of Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: October 1, 1998 REASON: Failure to submit an acceptable plan of correction.
Brij Mittal, M.D.
SANCTION: Suspension of approval to receive Medicare payment for all services and suspension of CLIA certificate. EFFECTIVE DATE: August 3, 1998 REASON: Failure to submit an acceptable plan of correction.
Abdul Naji, Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certificate. EFFECTIVE DATE: December 23, 1998 (Medicare cancellation) REASON: Condition level non-compliance. STATUS: CLIA certificate revoked.
Steven Brigham, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory service, suspension and revocation of CLIA certificate. EFFECTIVE DATE: March 7, 1998 REASON: 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. STATUS: Revocation pending hearing.
Rosaura Rivera, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services, suspension and revocation of CLIA certification. EFFECTIVE DATE: June 10, 1998 REASON: Failure to submit an acceptable plan of correction.
Joseph Kass, M.D.
SANCTION: Limitation of CLIA certificate and Medicare payment canceled for the specialty area. EFFECTIVE DATE: August 12, 1998 REASON: Proficiency testing failure for the analyte of Prothrombin Time testing.
Davill Armstrong, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services. EFFECTIVE DATE: March 13, 1998 REASON: Condition level non-compliance.
Robert L. Gillett, Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: December 21, 1998 REASON: Condition level non-compliance causing immediate and serious threat to the health and safety of the laboratory's patients.
Dr. Joseph Roell, Director
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and revocation of CLIA certificate. EFFECTIVE DATE: July 5,1998 (Medicare cancellation) August 15, 1998 (Revocation) REASON: Condition level non-compliance and unsuccessful participation in proficiency testing.
McKay Christian, M.D., Director
SANCTION: CLIA certificate limited for Endocrinology, Toxicology and Prothrombin Time testing. Medicare payment canceled for the areas limited. EFFECTIVE DATE: March 18, 1998 REASON: Proficiency Testing failure for the subspecialties of Endocrinology, Toxicology and Prothrombin Time.
Isaac J. Osborne, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: March 23, 1998 REASON: Failure to submit an acceptable plan of correction.
N. Abbulgani, M.D.
SANCTION: Cancellation of approval to receive Medicare payment for all laboratory services and suspension of CLIA certificate. EFFECTIVE DATE: March 23, 1998 REASON: Failure to submit an acceptable Plan of Correction. NONE 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; and (iv) If the laboratory has achieved compliance, the verified date of the compliance.
Michael Lacey, M.D., Director
SANCTION: Directed Plan of Correction, State Onsite Monitoring EFFECTIVE DATE: March 10, 1998 REASON: To assist the laboratory in achieving compliance and to identify patients having potentially incorrect diagnosis for gynecologic cytology.
ACE Medilab Services
SANCTION: Directed Portion of a Plan of Correction, Civil Money Penalty ($30,000) EFFECTIVE DATE: January 17, 1998 REASON: Immediate and serious threat to the health and safety of patients found during a State Agency complaint survey. Condition level non-compliance. STATUS: Revocation of CLIA certificate.
K. M. Ikram, M.D., Director
SANCTION: Directed Portion of a Plan of Correction, Civil Money Penalty ($30,000) EFFECTIVE DATE: July 1, 1998 REASON: Immediate and serious threat to the health and safety of patients found during State Agency survey. STATUS: Revocation of CLIA certificate.
Sol Teitelbaum, M.D., Director
SANCTION: Directed Portion of a Plan of Correction, Civil Money Penalty ($30,000) EFFECTIVE DATE: February 28, 1998 REASON: Immediate and serious threat to the health and safety of patients found during State Agency survey. STATUS: Revocation of CLIA certificate.
Jay Allen, M.D., Director
SANCTION: Civil Money Penalty ($40,000) EFFECTIVE DATE: May 26, 1998 REASON: Immediate and serious threat to the health and safety of patients found during State Agency survey. Failure to comply with reasonable request for information necessary to determine continued CLIA compliance resulted in Civil Money Penalty.
Penteleon De Jesus, M.D., Director
SANCTION: Directed Portion of a Plan of Correction, Civil Money Penalty ($30,000) EFFECTIVE DATE: December 31, 1998 REASON: Immediate and serious threat to the health and safety of patients found during State Agency complaint survey. STATUS: Revocation pending hearing.
Grand River Hospital District
SANCTION: Directed Plan of Correction, State Onsite Monitoring EFFECTIVE DATE: November 10, 1998 - April 13, 1999 REASON: The laboratory had not corrected all condition level deficiencies prior to the onsite revisit.
Lida H. Mattman, Ph.D., Director
SANCTION: Directed Portion of a Plan of Correction. EFFECTIVE DATE: August 12, 1998 REASON: Condition level non-compliance causing immediate jeopardy to the health and safety of the laboratory's patients STATUS: CLIA certificate was revoked on October 6, 1998.
Chariton Laboratory Services, Inc.
SANCTION: Directed Plan of Correction. EFFECTIVE DATE: February 1, 1998 REASON: Improper interpretation of gynecologic testing. STATUS: Compliance achieved May 21, 1998.
Metro Laboratory, PA
SANCTION: Directed Plan of Correction, State Onsite Monitoring. EFFECTIVE DATE: May 8, 1998 REASON: Improper gynecologic testing procedures and diagnoses. STATUS: The facility subsequently withdrew certification for the subspecialty of Cytology. 5. A LIST OF LABORATORIES WHOSE ACCREDITATION HAS BEEN WITHDRAWN OR REVOKED AND THE REASON FOR THE WITHDRAWAL OR REVOCATION. (Suspensions are included in this section.)
Long Beach Doctor's Hospital
SANCTION: Non-accreditation (JCAHO). EFFECTIVE DATE: June 18, 1998 REASON: The laboratory was part of a hospital given a preliminary non-accreditation decision based on hospital (not laboratory) issues. Because JCAHO accredits the organization as a whole, a laboratory in an organization that is denied accreditation automatically is denied laboratory accreditation. Facility ceased operations June 23, 1998.
Eric Felt, M.D., Ph.D.
SANCTION: Denial of Accreditation (COLA). EFFECTIVE DATE: July 24, 1998 REASON: Failure to enroll in proficiency testing program. Deliberate disregard for COLA policy. STATUS: Readmission September 24, 1998 after satisfactory correction of deficiencies.
K. Melahoures, M.D.
SANCTION: Denial of accreditation (COLA). EFFECTIVE DATE: January 31, 1998 REASON: Failure of laboratory to meet the deadlines for providing information and documentation as stipulated by COLA's Accreditation Committee regarding appropriate quality control for gram stain and antibacterial susceptibility testing and obtaining the services of laboratory consultant in microbiology.
South Coast Internal Medicine
SANCTION: Denial of Accreditation (COLA). EFFECTIVE DATE: July 24, 1998 REASON: Deliberate disregard of policy. Continuing to test an analyte, specialty, subspecialty after failing to meet proficiency test performance criteria.
George W. Kindschi, M.D., Director
SANCTION: Denial of Accreditation (College of American Pathologists). EFFECTIVE DATE: April 29, 1998 REASON: A high number of deficiencies were found during the October 1997 survey, and a significantly high number of recurring deficiencies were found from the 1995 survey. STATUS: Laboratory was subsequently surveyed by State Agency. Condition level noncompliance found. The noncompliance was corrected and the laboratory's certificate status changed to certificate of compliance.
Henry Roztoczynski, M.D., Director
SANCTION: Denial of Accreditation (COLA). EFFECTIVE DATE: May 4, 1998 REASON: Failure to adhere to COLA-imposed required improvements, deliberate disregard for COLA standards and policies, and failure to enroll in a COLA-approved proficiency testing program.
Clinigen Incorporated
SANCTION: Denial of Accreditation (College of American Pathologists). EFFECTIVE DATE: June 15, 1998 REASON: Due to the deficiencies identified at the laboratory's September 1997 initial inspection and April 1998 reinspection. The laboratory was not in compliance with the CAP standard for quality control and performance improvement.
Laboratory Corporation of America Holdings
SANCTION: Suspension of Accreditation (American Society for Histocompatibility and Immunogenetics) EFFECTIVE DATE: October 11,1998 REASON: Deficiencies in standards which resulted in incorrect typing results. STATUS: Reinstatement.
Miro Diagnostics, Inc.
SANCTION: Suspension of Accreditation (American Society for Histocompatibility and Immunogenetics). EFFECTIVE DATE: February 23, 1998 REASON: Unsuccessful proficiency testing. STATUS: Reinstatement of Accreditation April 16, 1998. 6. ALL APPEALS AND HEARING DECISIONS.
Eugene R. Pocock, M.D., Director
SANCTION: Medicare cancellation and revocation of CLIA certificate. HEARING DECISION: Hearing filed September 13, 1996 was withdrawn February 27, 1997 and sanctions to suspend and revoke CLIA certification, and cancel Medicare/Medicaid payments, became final. The director requested hearing to appeal the prohibition against his owning, operating or directing another laboratory for a period of two years from the date of revocation of the CLIA certificate of Watson Medical Laboratories, Inc. The administrative law judge rendered his decision on March 31, 1998 upholding HCFA's determination to prohibit Dr. Pocock from owning, operating or directing a laboratory for a two year period, from April 9, 1998 through April 8, 2000.
Ara M. Minasian, Director
SANCTION: Medicare cancellation, suspension and revocation of CLIA certificate. HEARING DECISION: Dismissal due to settlement agreement. Laboratory withdrew hearing request and will not contest any findings of noncompliance and resulting remedies to the surveys conducted on July 24, 1997 and January 20, 1998, either administratively, or in any State or Federal court. The laboratory director/owner agreed to cease clinical testing.
Ward General Practice Clinic
SANCTION: Medicare cancellation, suspension and revocation of CLIA certificate. HEARING DECISION: The laboratory withdrew hearing request and on February 3, 1998 administrative law judge dismissed the case. CLIA certification revoked effective February 3, 1998.
Khai Van Vo, M.D., Director
SANCTION: Medicare cancellation, suspension and proposed revocation of CLIA certificate. HEARING DECISION: Dismissal due to settlement agreement. The suspension and Medical cancellation sanctions imposed on February 17, 1998 were lifted on June 21, 1998. The laboratory certificate status was changed from a certificate of compliance to a certificate of waiver on June 22, 1998, and cannot be changed before February 16, 2000.
Davill Armstrong, M.D.
SANCTION: Revocation of CLIA certificate. HEARING DECISION: On November 12, 1998, an administrative law judge dismissed the case based on a settlement agreement. The laboratory certificate status was changed from certificate of compliance to certificate of waiver and cannot be changed before November 13, 2000. 7. A LIST OF LABORATORIES AGAINST WHICH HCFA HAS BROUGHT SUIT UNDER SECTION 493.1846 AND THE REASON 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 ALSO INCLUDES SETTLEMENTS AND ARE BASED IN PART ON INFORMATION SUPPLIED BY HHS AND THE OFFICE OF INSPECTOR GENERAL.)
Corning Life Sciences
STATUS: Entered into a civil settlement with the U.S. Department of Justice and HHS-OIG in the amount of $6.8 million to resolve issues relating to false claims to the government for laboratory services. 9. CORRECTION OF ANY ERRONEOUS STATEMENTS OR INFORMATION THAT APPEARED IN THE 1997 REGISTRY. NONE 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.
Jirald Federman, M.D.
SANCTION: Laboratory was directed by accreditation organization to cease testing for problem analyte. EFFECTIVE DATE: July 29, 1998 REASON: Laboratory failed to remit "Cease Testing Agreement" for repeated unsuccessful proficiency testing.
Eastern Idaho Medical Consultants
ACTION: Discontinue testing of serum glutomine pyrovate transaminase (SGPT) based on proficiency testing performance. EFFECTIVE DATE: December 11, 1998 STATUS: Laboratory has subsequently passed PT and has been reinstated for the testing of SGPT.
John M. Gevurtz, M.D., Laboratory
ACTION: Discontinue testing in bacteriology due to proficiency testing performance. EFFECTIVE DATE: August 26, 1998 STATUS: Laboratory ceased bacteriology testing.
Dunes Family Health Care Laboratory
ACTION: Discontinue testing of urine colony count and serum pregnancy testing due to non-enrollment in proficiency testing and personnel competency. EFFECTIVE DATE: June 5, 1998 STATUS: Laboratory subsequently passed proficiency testing. Testing of urine colony count and serum pregnancy reinstated effective September 3, 1998.
Pioneer Memorial Hospital Laboratory
ACTION: Discontinue testing in bacteriology due to proficiency testing performance. EFFECTIVE DATE: May 7, 1998 STATUS: Laboratory is limited to performing only gram stain and rapid streps test in bacteriology.
Okanogan-Douglas Hospital
ACTION: Condition equivalent deficiencies in proficiency testing, personnel, record keeping, quality assurance and quality control. EFFECTIVE DATE: October 5, 1998 STATUS: Laboratory has corrected deficiencies and is currently being monitored for continued compliance.
Perry, Robert & Perry, Laura C, DO.
ACTION: Discontinue testing in hemotology due to proficiency testing performance. EFFECTIVE DATE: April 22, 1998 STATUS: Laboratory subsequently passed proficiency testing and has been reinstated for the testing in hematology on November 13, 1998.
Medalia Women's Care
ACTION: Condition equivalent deficiencies in record keeping, quality assurance and quality control. EFFECTIVE DATE: July 16, 1998 STATUS: State is monitoring laboratory's progress in correcting deficiencies.
Gene E. Smith M.D., Director
ACTION: Discontinue auto differential testing due to proficiency testing performance. EFFECTIVE DATE: September 6, 1998 STATUS: Laboratory has not resumed testing of auto differentials.
Steven Silverstein, M.D.
ACTION: Discontinue bacteriology testing due to deficiencies cited in proficiency testing personnel, record keeping, quality assurance and quality control. EFFECTIVE DATE: October 12, 1998 STATUS: Laboratory no longer performs bacteriology testing.
Island Family Medicine
ACTION: Condition equivalent deficiencies in proficiency testing personnel, record keeping, quality assurance and quality control. EFFECTIVE DATE: August 14, 1998 STATUS: State is monitoring laboratory's progress in correcting deficiencies.
Women's Healthcare Center
ACTION: Discontinue Rh testing due to proficiency testing performance. EFFECTIVE DATE: March 30, 1998 STATUS: Laboratory has subsequently passed proficiency testing, but has not resumed Rh testing.
Calumet Medical Center
ACTION: Laboratory was directed by accrediting organization (JCAHO) to cease testing for Phenobarbital and Cholesterol following unsuccessful PT results. EFFECTIVE DATE: March 20, 1998 STATUS: After corrective action and two acceptable successive PT results, the sanction was lifted. Last Modified on Thursday, September 16, 2004
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Centers for Medicare & Medicaid Services
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