WARNING LETTER

November 4, 2004

VIA FEDEX

Re: MQSA Inspection ID # 1975330009

John Ellis, Radiology Director
Kaiser Permanente Medical Center-Vallejo
Radiology Department
975 Sereno Drive
Vallejo, California 94589

Dear John Ellis,

On July 1, 2004, a representative of the State of California, acting in behalf of the Food and Drug Administration (FDA), inspected your facility. 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 for mammography. These requirements help protect the ‘health of women by assuring that a facility can perform quality mammography.

The inspection revealed the following violations of the MQSA at your facility:

Level 1 (Repeat): Mammograms were processed in processor 1, [redacted] room Mammo at site Kaiser Permanente Medical Center - Vallejo, when it was out of limits on 10 separate days. Specifically, December 15 and19, 2003; January 27, 2004; February 9, 25 and 27, 2004; May 6-9, 2004. [21 CFR 900.12(e)(1)(i),(ii),(iii)]

Level 2 (Repeat): 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 5, [redacted], room Mammo. [21 CFR 900.12(e)(1)(iii)]

Level 2 (Repeat): Corrective actions for process QC failures were not documented at least once for processor 2, [redacted], room Main at site Kaiser Permanente Medical Center-Vallejo. [21 CFR 900.12(e)(1)(i),(ii),(iii)]

Level 2 (Repeat): Corrective actions for processor QC failures were not documented at least once for processor 1, [redacted] room Mammo at site Kaiser Permanente Medical Center - Vallejo. [21 CFR 900.12(e)(1)(i),(ii),(iii)]

Level 2: The mammography processor equipment (by a medical physicist) for processor 2, [redacted], room Main, site Kaiser Permanente Medical Center - Vallejo was not done. [21 CFR 900.12(e)(10)]

Level 2: Processor QC records were missing at least 2 but less than 5 consecutive days for processor 1, [redacted] Other, room Mammo at site Kaiser Permanente Medical Center - Vallejo. [21 CFR 900.12(e)(1) and (2)]

Level 2: Failed to produce documents verifying that the radiologic technologist [redacted] (13 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. [21 CFR 900.12(a)(2)(i)(ii)(A)]

Level 2: Failed to produce documents verifying that the radiologic technologist [redacted] (15 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. [21 CFR 900.12(a)(2)(i)(ii)(A)]

Level 2: Failed to produce documents verifying that the radiologic technologists [redacted] (8 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. [21 CFR 900.12(a)(2)(i)(ii)(A)]

Level 2: Failed to produce documents verifying that the radiologic technologist [redacted] (5 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. [21 CFR 900.12(a)(2)(i)(ii)(A)]

Level 2: Failed to produce documents verifying that the radiologic technologist [redacted] met the continuing experience requirement of having performed 200 mammography examinations. [21 CFR 900.12(a)(2)(iv)(A)]

These violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility. FDA may take additional actions, which may include, but are 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 10,000 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; and
  
• Seeking a court injunction enjoining further mammography.

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

Please explain to this office in writing, within fifteen (15) working days after receiving this letter:

1. The specific steps you have taken 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; and

3. Sample records that demonstrate compliance for the level 2 non-compliances listed, if the findings relate to quality control or other records (Note: Patient names or identification should be deleted from any copies submitted).

The other items identified as Level 3 Noncompliance on the facility post inspection report from July 1, 2004, should also be corrected.

If your facility is unable to complete corrective action within 15 working days, you should state the reason for the delay and provide a timeframe within which corrections will be completed. Please submit your response to this letter to:

Don A. Leeseberg, Jr., Radiological Health Specialist
United States Food & Drug Administration
1431 Harbor Bay Parkway
Alameda, CA 94502

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to noncompliances related to the recent inspection 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 more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Don A. Leeseberg, Jr., Radiological Health Specialist at 510-337-6877.

Sincerely yours,

/s/

Barbara J. Cassens
District Director

cc:
Mr. Ed Gloor, MQSA Inspections Monitor
Radiological Health Branch
Div. of Food, Drug & Radiation Safety
Calif. Dept. of Health Services
PO Box 942732
Sacramento, CA 92234-7230

 Vallejo WARNING LETTER - November 4, 2004 

http://www.fda.gov/foi/warning_letters/g4343d.htm
Cincinnati, Ohio - WARNING LETTER
CIN-03-19031
October 15, 2003

Hayward WARNING LETTER - November 6, 2002

http://www.fda.gov
12/10/01
Vallejo, California

http://www.fda.gov/foi/warning_letters/g3257d.pdf
Warning Letter
June 8, 2001 -  Panorama City, California
included in this letter - Lancaster, California and Santa Clarita, California

http://www.fda.gov/foi/warning_letters/g1375d.pdf
June 8, 2001
Baldwin Park, California and Montebello, California

http://www.fda.gov/foi/warning_letters/m4200n.pdf
09/14/00
Pleasonton, California

http://www.fda.gov/foi/warning_letters/m4199n.pdf
09/14/00
Antioch, California

http://www.fda.gov/foi/warning_letters/m4246n.pdf
09/29/00
Mountain View, California

http://www.fda.gov/foi/warning_letters/m3096n.pdf
10/22/99

http://www.fda.gov/foi/warning_letters/m2981n.pdf
Atlanta, Georgia
09/02/99
Atlanta, Georgia

http://www.fda.gov/foi/warning_letters/m2130n.pdf
October 19, 1998 - Atlanta, Georgia Division
The interpreting physician did not meet the requirement of being board certified-by any of the approved boards or having two months of the approved full-time training in the interpretation of mammograms. The radiologic technologist got the same warning.

http://www.fda.gov/foi/warning_letters/d1771b.pdf
05/07/98 
San Francisco, California

http://www.fda.gov/foi/warning_letters/d1781b.pdf
05/14/98
San Francisco, California
 
 

 

Little Benefit Adding Breast Exam to Mammography
WEDNESDAY, Feb. 9 (HealthDay News) -- Women gain only a modest benefit in cancer detection by adding clinical breast examination to mammography screening, according to a new study.

"Adding clinical breast examination to screening mammography detected an additional 25 (4 percent) cancers in the study population," researcher Nina Oestreicher, of the Kaiser Permanente Division of Research in Oakland, Calif., said in a prepared statement.

The study of 61,688 women found that clinical breast exam plus mammography detected 82 percent of cancers, mammography alone detected 78 percent of cancers, and clinical breast examination alone detected 21 percent of cancers.

Oestreicher said that, given this modest benefit and studies that suggest clinical breast exams alone do little to reduce breast cancer death, adding a clinical exam to standard mammography screening probably won't lower breast cancer mortality.

Women with dense breasts were most likely to benefit from clinical breast examination, the study found, but they were also more than twice as likely to receive a false positive report -- findings that appear suspicious but turn out to be benign.

The findings appear in the February issue of the American Journal of Roentgenology.

More information

The National Cancer Institute has more about breast cancer screening (www.cancer.gov ).

-- Robert Preidt

Copyright © 2005 ScoutNews LLC. All rights reserved.

Last Updated: February 09, 2005

I wrote to the National Cancer Institute as I am sure many other people upon reading the above article.  The implication was made that this cutting back of medical examination was endorsed by the NCI.  They wrote back to me:

Thank you for your e-mail to the National Cancer Institute (NCI) regarding mammography screening and clinical breast exam in the detection of breast cancer.  The NCI, a component of the National Institutes of Health, is the Nation's principal agency for cancer research.  The Institute is committed to conducting research to improve screening methods for all types of cancer, including breast cancer.  Although the NCI gathers and disseminates scientific information on cancer screening, it does not usually set policy guidelines for screening recommendations.  The study you mentioned was conducted by Kaiser Permanente and, to our knowledge, was not funded by the NCI.  However, the NCI does have information on breast cancer screening that you may find useful.  It is important to discuss with a doctor how our information applies before making any decisions about treatment or care.  We encourage you to explore these Internet resources:

--NCI's Breast Cancer Home Page:  This Web page provides links to NCI resources about prevention, screening, treatment, clinical trials, and
supportive care for this type of cancer.  This page can be found on the NCI's Web site at http://www.cancer.gov/cancertopics/types/breast/ on the
Internet.

--"PDQ(R) Screening Summary for Patients on Breast Cancer":  This summary of information from PDQ, the NCI's comprehensive cancer information database, provides information about methods of cancer detection, including new imaging technologies, tumor markers, and biopsy procedures.  This resource can be found at
http://www.cancer.gov/cancertopics/pdq/screening/breast/patient/ on the Internet.

--"What You Need To Know About(TM) Breast Cancer":  This NCI publication is designed to help patients with breast cancer and their families and friends better understand this disease.  This resource discusses screening and early detection, symptoms, diagnosis, treatment, and rehabilitation.  It also has information to help patients cope with breast cancer.  This publication is
available at http://www.cancer.gov/cancertopics/wyntk/breast on the Internet.

--"Improving Methods for Breast Cancer Detection and Diagnosis":  This NCI fact sheet describes digital mammography, ultrasound, MRI, biopsy, and other tests used to detect and diagnose breast cancer.  This resource can be found
at http://cis.nci.nih.gov/fact/5_14.htm on the Internet.

--"Screening Mammograms:  Questions and Answers":  This NCI fact sheet defines screening mammograms and outlines their advantages and limitations. It also lists incidence rates and risk factors for breast cancer.  This
resource is available at http://cis.nci.nih.gov/fact/5_28.htm on the Internet.

--"Understanding Breast Changes:  A Health Guide for Women":  This NCI
publication provides information on breast changes and methods for detecting
breast cancer.  It is available at
http://www.cancer.gov/cancertopics/understanding-breast-changes on the
Internet.

We hope this information is helpful.
 

National Cancer Institute

Today the original news article has been modified in content and at:
http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=7606819
 By Amy Norton

NEW YORK (Reuters Health) - Having a doctor examine the breasts for potential signs of cancer may add little to the benefits of mammography screening, a large study suggests.

Researchers found that among nearly 62,000 women age 40 or older, the combination of mammography and a clinical breast exam detected only a small number of additional breast cancers compared with mammography alone.

Although the clinical exam did help catch cancers in women with dense breast tissue, in particular, it also put these women at greater risk of being told they might have cancer when they did not.

However, the findings should not be interpreted as a recommendation against clinical breast exams, according to the study's lead author.

"We're just trying to lay out the information for women," said Dr. Nina Oestreicher, a researcher at Kaiser Permanente in Oakland, California.

"It's really up to women and their doctors to make the decision," she told Reuters Health, noting that many factors, including a woman's personal risk of breast cancer and her degree of concern about the disease, could influence the choice to have regular clinical breast exams in addition to mammography.

Experts recommend that women at average risk of breast cancer have a mammogram every one to two years starting at age 40. Though mammography is imperfect, it is credited with reducing breast cancer death rates in a number of countries where the test is routinely performed.

However, the value of also having regular clinical breast exams, in which a doctor observes and feels the breasts for lumps and other abnormalities, has been unclear.

The new study, published in the American Journal of Roentgenology, suggests that much depends on the density of a woman's breasts. Oestreicher and her colleagues found that clinical breast exams carried a greater benefit for women with more dense breast tissue, compared with those with more fatty tissue.

Dense breasts contain more glandular and connective tissue than fat, making it easier for tumors to be obscured on mammograms. So in some cases, palpating the breast for lumps can catch a tumor missed on the imaging test.

On the flip side, study patients with dense breasts were also nearly twice as likely to get a false-positive result from a clinical breast exam, which can lead to unnecessary biopsies. 

According to Oestreicher, women should discuss these pros and cons of clinical breast exams with their doctors, then base their decisions on their own circumstances. For example, she noted, a woman who is particularly concerned about breast cancer may feel that the modest benefit of clinical breast exams is worth the possibility of getting a false alarm.

Since women with denser breasts benefit more from clinical exams, it might be helpful, Oestreicher said, for women to find out their breast density, which can be determined when they have a mammogram.

The current study included 61,688 women who had undergone at least one screening with mammography and a breast exam.

The researchers found that mammography detected 78 percent of the cancers in these women, while breast exams were able to catch 21 percent. The addition of a clinical exam to mammography picked up 25 cancer cases (4 percent) in addition to those detected by mammography alone.

SOURCE: American Journal of Roentgenology, February 2005.