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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Century City Hospital 07-Mar-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

19900 MacArthur Blvd., Ste 300

Irvine, California 92612-2445

Telephone (949) 798-7600

WARNING LETTER

Certified Mail

Return Receipt Requested

March 7, 2002

W/L Number: 27 - 02

Inspection ID: 2190140005

CFN: 20-30,334

FEI: 1000519450

Gory Alpert

Administrative Director - Clinical Services

Century City Hospital

2080 Century Park East; Suite #f 04

Los Angeles, CA 90067-2096

Dear Mr. Alpert:

We are writing to you because on November 26, 2001, your facility was inspected by a

representative of the State of California acting in behalf of the U. S. Food and Drug

Administration (FDA). This inspection revealed a serious regulatory problem involving

the mammography at your facility.

Under a United States Federal law, the Mammography Quality Standards Act of 1992

(MQSA), 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 finding

at your facility:

- Level 2: The measured fog density is equal to 0.35 for mammography darkroom. This

is a REPEAT violation.

The specific problem noted above appeared on your MQSA Facility Inspection Report

which was issued to your facility at the close of the inspection. This problem is identified

as repeat Level 2 because it identifies a failure to meet a significant MQSA requirement

in Title 2 1 Code of Federal Regulations section 900.12(e)(4)(i).

The background on this situation involves a trend of MQSA noncompliance. On

November 20, 2000, your facility was inspected (Inspection ID number 2190140004)

with a partial finding of "***The measured fog density is equal to 0.2 in the

mammography darkroom. ** *". On January 30, 2001, you wrote us a letter and stated

? Lower watt bulbs have been ordered and installed for the Mammo darkroom. Also we

are using more filters over the light to maintain acceptable limits for the fog test. We will

continue to use the lower watt bulbs, and keep the filters over the darkroom light.***".

Based upon your willingness to correct this problem, we wrote your facility on February

15, 2001 that your voluntary corrective action was adequate, but subject to evaluation

during your next regularly scheduled MQSA inspection, For your 2001 MQSA

inspection, the same problem has been detected again only now at a higher level (0.35).

As you should be aware, extraneous light and/or improper light bulbs, during developing

of mammographic X-ray films, can decrease the quality of the mammogram presented to

your radiologist(s) for medical interpretation.

Because this condition may be symptomatic of serious underlying problems that could

compromise the quality of mammography at your facility, it represents a serious violation

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 (DPC), 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, or obtaining a court injunction against

further mammography.

In addition, your response should address the Level 2 findings that were listed on the

inspection report provided to you at the close of the inspection. These Level 2 findings

are:

- Level 2: Medical audit and outcome analysis was not performed annually. This is a

violation of Title 21 Code of Federal Regulations section 900.12(f)(l).

- Level 2: Medical audit and outcome analysis was not done separately for each

individual. This is a violation of Title 21 Code of Federal Regulations section

900.12(f)( 1).

- Level 2: Medical audit and outcome analysis was not done for the fGlity as a whole.

This is a violation of Title 21 Code of Federal Regulations section 900.12(f)(l).

- Level 2: Phantom quality control (QC) records were missing for the weeks of

November 20th through the 24th of the year 2000 plus February 12th through the 16th and

February 26th through March 2nd of the year 2001 unit #3 (a [redacted] machine, model [redacted], serial number [redacted] which is located in the mammography room. This is a violation of Title 21 Code of Federal Regulations section 900.22(e)(2).

- Level 2: The time period between the previous and current surveys for x-ray unit #3 (a

[redacted] machine, model [redacted], serial number [redacted]) exceeds fourteen (14) months. This is a violation of Title 21 Code of Federal Regulations section 900,12(e)(9).

- Level 2: Not all positive mammograms were entered in the tracking system. This is a

violation of Title 21 Code of Federal Regulations section 900.12(f)(1).

Your response should also include specifically why your proposed corrective action was

not implemented or improperly implemented in January 2001. Who (by name and title)

had the authority, capability, and responsibility to carryout that corrective action and why

that individual did not. Finally, please submit not only your applicable revised quality

assurance section(s) in reference to correcting this problem, but additionally your

validation process to verify that the change procedure is, in fact, being carried out

correctly this time.

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 you received this letter:

- the specific steps you have taken to correct all of the violations noted in this letter;

- each step your facility is taking to prevent the recurrence of similar violations;

- equipment settings (including technique factors), raw test data, and calculated final

results, where appropriate; and

- please provide sample records that demonstrate proper record keeping procedures, if the

findings relate to quality control or other records (Note: Patient names or identification

should be deleted from any copies submitted).

Please submit your response to:

Thomas L. Sawyer

Director, Compliance Branch

U.S. Food & Drug Administration

19900 MacArthur Blvd.; Suite #300

Irvine, CA 92612-2445

Phone: (949) 798-7600

Finally, you should understand that 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 ah 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 (telephone number: l-800-838-7715) or through

the Internet at http://www.fda.gov.

If you have more specific questions about mammography facility requirements, or about

the content of this letter, please feel free to contact Scott Goff (the Compliance Officer

assigned to this case) at telephone number 949-798-7644.

Sincerely,

Alonza E. Cruse

District Director