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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Hemet Valley MedicalCenter 28-Jan-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

Certified Mail

Return Receipt Requested

January 28, 2002

WARNING LETTER

W/L Number: 25 - 02

Inspection ID: 1530150007

CFN: 2029787

FEI: 1000519501

Lawrence DiCapua, M.D.

Medical Director

Hemet Valley Medical Center

1117 East Devonshire Avenue

Hemet, California 92543-3084

Dear Dr. DiCapua:

We are writing to you because on January 8, 2002, 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 specific problem, noted below, 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.

- Level 2: Corrective action before further exams (for a failing image score, or a

phantom background optical density, or density difference outside the allowable

regulatory limits) was not documented for unit #2 (a Lorad Medical Systems Inc.

machine, model MIV, serial number 19403991434) which is located in the

mammography room. Specifically, on May 22nd and November 26th of 2001, the X-ray

unit was out of compliance with no corrective action documented for May 22, 2001.

Additionally, on May 28, 2001 it was determined that a phantom check was missed, and

on June 4, 200l a phantom check was performed with no corrective action documented

for that May 28, 2001 problem omission. This is a REPEAT violation.

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 finding that was listed on the

inspection report provided to you at the close of the inspection. This Level 2 finding is:

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

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; 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),

Further, on January 30, 2001, your facility was MQSA inspected (Inspection ID number

1530150006) and a similar like problem, as cited under REPEAT Level 2 herein, was

observed. On February 8, 2001, MS Helen J. King (Lead Mammography Technologist),

of your medical facility, wrote us. The proposed corrective action, in her letter, reads in

****It was found*** I had not documented the corrective actions taken and had not

documented the retesting of the phantom * * * . To avoid this in the future, I will highlight the +/- limits on my graphs and will document the retesting of the phantom and the corrective actions taken** * . Because of her willingness to correct the problem in the

2001 inspection, we closed out the inspection with a letter to her dated February 20, 2001.

We are concerned that the problem has recurred and, additionally, your facility?s corrective action plan has been, presumably, ineffective. Therefore, your response

should specifically explain why the proposed corrective action, in January 2001, did not

solve the problem noted in the January 2002 inspection Also, how has your quality

assurance procedure(s) been revised and validated to permanently correct this recurring

event.

Please submit your response to:

Thomas L. Sawyer

Director, Compliance Branch

U.S. Food & Drug Administration

I9900 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 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 (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 yours,

Alonza E. Cruse

District Director