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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Raytel Medical Imaging 23-Jan-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

300 Pearl Street, Suite 100
Buffalo, NY 14202



WARNING LETTER

NYK 2006-05

January 23, 2006

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Re: Raytel Medical Imaging - Bronx, NY
MQSA Inspection ID 2267570005
FEI 3003469592

Jeffrey Flanegin, President
Raytel Medical Imaging
Park Professional Suites
430 Park Avenue, Suite 102
Collegeville, PA 19426

Dear Mr. Flanegin

On November 29, 2005, a representative of the Food and Drug Administration (FDA) inspected your facility located at Raytel Medical Imaging - Bronx, 1180 Morris Park Avenue, Bronx, NY. This inspection revealed a serious problem involving the conduct of mammography at your facility. Under the Mammography Quality Standards Act of 1992 ("MQSA") which is codified in Section 263b of Title 42 of the United States Code (USC), your facility must meet specific requirements to practice mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography.

The inspection revealed violations of the MQSA at your facility. These violations were noted on the MQSA Facility Inspection Report that our investigator left along with the document "Important Information about Your MQSA Inspection " with Kathleen Burmel and [redacted] of your facility at the close of the inspection and also mailed to your facility on December 6, 2005. The violations that the Bronx facility was required to respond in writing to are again identified below:

Level 1: Processor QC records in the month of 11/2005 were missing for at least 30% of operating days, for processor MAIN, [redacted], Other, room Dark Room at site Raytel Medical Imaging - Bronx [see 21CFR 900:12(e)(1)]

Level 1: Processor QC records were missing at least 5 consecutive days for processor MAIN, [redacted], Other, room Dark Room at site Raytel Medical Imaging-Bronx [see 21 CFR 900.12(e)(1)]

Level 1: Phantom QC records were missing for at least 4 weeks for unit 1, [redacted] 800, room Mammography Room [see 21 CFR 900.12(d)(2)]

Level 2: Medical audit and outcome analysis was not done for the facility as a whole at site Raytel Medical Imaging - Bronx (REPEAT) [see 21 CFR 900.12(f)(1)]

Level 2: Medical audit and outcome analysis was not performed annually at site Raytel Medical Imaging - Bronx (REPEAT) [see 21 CFR 900.12(f)(2)]

Level 2: Medical audit and outcome analysis was not done separately for each individual at site Raytel medical Imaging - Bronx (REPEAT) [see 21 CFR 900.12(f)(1)]

Level 2: There were no examples of, not attempts, to get biopsy results for site Raytel Medical Imaging - Bronx (REPEAT) [see 21 CFR 900.12(f)(1)]

Level 2: The medical physicist's survey for x-ray unit 1,[redacted], room Mammography Room is incomplete because the following tests were inadequate or not done:

- No AEC performance - Reproducibility [see 21 CFR 900.12(e)(5)(v)]
- Numerical results were not given [see 21 CFR 900.12(e)(9)(ii)
- No AEC performance capability [see 21 CFR 900.12(e)(5)(i)]
- Numerical results were not given [see 21 CFR 900.12(e)(9)(ii)]

Level 2 : Failed to produce documents verifying* that the radiologic technologist [redacted] (12 CEU's in 36 months) met the continuing education requirement of having taught or completed at least 15 continuing education units in mammography in 36 months [see 21 CFR 900.12(a)(2)(ili)(A) and (C)]

Level 2: 5 of 10 random reports reviewed did not contain an acceptable assessment category for site Raytel Medical Imaging - Bronx [see 21 CFR 900.12(c)(1)(iv)]

Level 2: Not all positive mammograms were entered in the tracking system for site Raytel Medical Imaging - Bronx [see 21 CFR 900.12(f)(1)]

Level 2: There is no designated audit (reviewing) interpreting physician for site Raytel Medical Imaging - Bronx [see 21 CFR 900.12(f)(3)]

Level 3: The QA program is inadequate for site Raytel Medical Imaging - Bronx the missing or incomplete items are listed below (REPEAT)

- Personnel responsibilities [see 21 CFR 900.12(d)(2)]
- Current technique tables/charts [see 21 CFR 900.12(d)(2)]

Level 3: The required personnel qualification documents were not available during the inspection (REPEAT) [see 21 CFR 900.12(a)(4)

Additionally, five initial Level 3 noncompliances, not listed here, were also noted on the MQSA Facility Inspection Report sent to you. While the facility is also responsible for correction of those noncompliances, because they are initial (rather than repeat) Level 3 noncompliances, the facility is not required to address them in writing to FDA at this time.

Our November 29, 2005 inspection was performed as a follow-up inspection to the facility's June 1, 2005 annual inspection. The facility initially failed to respond to the noncompliances noted during the June 1, 2005 inspection. We contacted the facility and subsequently received an incomplete response on July 11, 2005. The November 29, 2005 follow-up inspection revealed the facility failed to correct the six noncompliances listed above identified as (REPEAT) and additionally noted new (initial) noncompliances listed above.

On December 19, 2005 we-received a response to the November 29, 2005 MQSA Facility Inspection Report. The response was inadequate in that it either does not adequately respond to or failed to address corrective action for the following noncompliances:

Level 2: The medical physicist's survey for x-ray unit 1, [redacted] room Mammography Room is incomplete because the following tests were inadequate or not done:

- No AEC performance - Reproducibility [see 21 CFR 900.12(e)(5)(v)]
- Numerical results were not given [see 21 CFR 900.12(e)(9)(ii)
- No AEC performance capability [see 21 CFR 900.12(e)(5)(i)]
- Numerical results were not given [see 21 CFR 900.12(e)(9)(ii)]

Level 2: There is no designated audit (reviewing) interpreting physician for site Raytel Medical Imaging - Bronx [see 21 CFR 900.12(f)(3)]

Level 3: The required personnel qualification documents were not available during the inspection (REPEAT) [see 21 CFR 900.12(a)(4)

Because the continued failure to resolve violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions, including, but not limited to, the following:

  • requiring your facility to undergo an Additional Mammography Review

  • placing your facility under a Directed Plan of Correction

  • charging your facility for the cost of on-site monitoring

  • seeking civil money penalties up to $11,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA standards

  • seeking to suspend or revoke your facility's FDA certificate

  • seeking a court injunction against your facility

See 42 USC 263b(h)-(j) and 21 CFR 900.12(j).

FDA may need to perform a Compliance Follow-up Inspection to determine that each problem at your facility has been corrected.

You should respond in writing to FDA within fifteen (15) working days from the date you received this letter. Your response should address the findings listed above and include:

1. the specific steps you have taken, or will take, to correct all of the violations noted in this letter, including projected timeframes for implementing those steps;

2. the specific steps you have taken, or will take, to prevent the recurrence of similar violations, including projected timeframes for implementing those steps;

3. sample records that demonstrate proper record keeping and procedures.

Please submit your response to this letter to:

Patricia A. Clark, Compliance Officer
U.S. Food and Drug Administration
300 Pearl Street, Suite 100
Buffalo, New York 14202

Please send a copy of your response to:

Dorothy Pender
New York City Department of Health
Bureau of Radiological Health
2 Lafayette Street, 11th Floor
New York, New York 10007

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection(s) of your facility 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, MD 21045-6057 (1- 800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/index.html.

If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Patricia A. Clark, Compliance Officer at 716-551- 4461, extension 3168.

Sincerely yours,

/S/

Edward W. Thomas
Acting District Director