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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

OBGYN Associates of the Southern Tier 05-Jul-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

 

New York District
Food & Drug Administration
300 Pearl Street Suite 100
Buffalo, NY 14202

July 5, 2001
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
NYK 2001-92
RE: Facility ID Number 214288

Bai Lee, M. D., CEO
OBGYN Associates of the Southern Tier
41 Arch Street
Johnson City, New York 13790

Dear Dr. Lee:

Your facility was inspected on June 27, 2001 by a representative of the New York State Department of Health, acting on behalf of the Food and Drug Administration (FDA). This inspection revealed serious regulatory problems involving the mammography at your facility.

Under a United States Federal law, the Mammography Quality Standards Act of 1992, your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography. The inspection revealed the following repeat Level 2 findings at your facility:

  • Failure to produce documents verifying the interpreting physician [redacted] M.D. met the initial experience requirement of having interpreted or multi-read 240 mammograms in six (6) months
  • Failure to produce documents verifying the interpreting physician [redacted] M.D. met the initial requirement of having 60 hours of category I medical education in mammography.

The specific problems noted above appeared on your MQSA Facility Inspection Report which was issued to your facility at the close of the inspection. These problems are identified as repeat Level 2 because they identify a failure to meet significant MQSA requirements and indicate failure by your facility to implement permanent correction of problems found during your previous inspection.

Because these conditions may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, they represent violations of the law which may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, placing your facility under a Directed Plan of Correction, charging your facility for the cost of on-site monitoring, assessing civil money penalties up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with MQSA standards; suspension or revocation of your facility?s FDA certificate, obtaining a court injunction against further mammography.

It is necessary for you to act on this matter immediately. Please explain to this office in writing within fifteen (15) working days from the date that you receive this letter each step your facility is taking to correct these violations and to prevent the recurrence of similar violations.

In addition, your response should address the Level 2 findings that were listed on the inspection report provided at the close of the inspection. The Level 2 findings are:

  • Failure to establish and comply with a written and documented system for collecting and resolving consumer complaints.
  • Failure to produce documents verifying the interpreting physician [redacted] M.D. met the continuing education requirement of having taught or completed at least 15 category 1 continuing medical education units in mammography in 36 months.
  • Failure to produce documents verifying the interpreting physician [redacted] continuing experience requirement of having interpreted or multi-read 960 mammograms in 24 months.
  • Failure to produce documents verifying the interpreting physician [redacted] M.D. met the continuing education requirement of having taught or completed at least 15 category 1 continuing medical education units in mammography in 36 months.
  • Failure to produce documents verifying the interpreting physician [redacted] M.D. met the continuing education requirement of having taught or completed at least 15 category 1 continuing medical education units in mammography in 36 months.
  • Failure to produce documents verifying the interpreting physician [redacted] M.D. met continuing experience requirement of having interpreted or multi-read 960 mammograms in 24 months.
  • Failure to perform the annual medical audit and outcome analysis.

Finally, you should understand there are many FDA requirements pertaining to mammography. This letter pertains only to findings of your inspection and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA?s requirements for mammography facilities by contacting the Mammography Quality Assurance Program Food and Drug Administration, P.O. Box 6057, Columbia, Maryland 21045-6057 (1-800-838-7715), or through the Internet at http://www.fda.gov.

Sincerely,

/s/
Timothy E. Hansen
Acting District Director