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FDA Consumer magazine
March-April 1999
by Carol Lewis
A former manager of four St. Louis-area mammography facilities has become the first person to be convicted of a crime related to the Mammography Quality Standards Act (MQSA) of 1992.
Krista Jane Miller of St. Louis was convicted in the U.S. District Court for the Eastern District of Missouri Sept. 18 of making a false statement in applying for accreditation of mammography equipment operated by C.R.G. Imaging Inc., doing business as Clayton Radiology. The 42-year-old certified mammography technologist was sentenced to two years probation and fined $1,000.
Congress passed MQSA after recognizing that poor-quality mammograms posed a serious health risk for women. The primary objectives of MQSA are to ensure that mammography is safe and reliable and that breast cancer is detected in its most treatable stages. FDA has the responsibility for implementing and enforcing MQSA, which requires that all mammography facilities in the United States meet certain stringent quality standards; receive accreditation from an FDA-approved accreditation body, such as the American College of Radiology (ACR); and undergo inspection annually. (See "FDA Sets Higher Standards for Mammography" in the January-February 1999 FDA Consumer.)
According to a case agent with FDA's Office of Criminal Investigations (OCI), Miller's plot to deceive the mammography accreditation board was uncovered shortly after ACR received a letter dated March 16, 1995, from an informant stating Miller's intent to misrepresent mammography x-ray film images in an accreditation reapplication. In January 1995, ACR had denied Clayton Radiology accreditation for its Ausonics Alpha III mammography x-ray unit because of poor image quality.
The informant, a former employee of Clayton Radiology, wrote that after the company failed to receive this accreditation, Miller indicated to employees that she would reapply by substituting films taken by an already accredited mobile x-ray unit. The informant further reported that Miller said no one would ever know about the switch.
Six days later, Miller resubmitted the application for accreditation, according to OCI. The application stated that the resubmitted images were from the Ausonics Alpha III unit.
To determine the validity of the informant's information, ACR, after receiving the films, arranged a follow-up investigation to examine the equipment. MQSA allows accrediting bodies to perform periodic on-site reviews of certified mammography facilities.
On April 21, 1995, ACR sent a letter to Clayton Radiology denying accreditation. The on-site visit had confirmed that the resubmitted film images were not taken by the Ausonics Alpha III x-ray unit, as Miller represented. Patient logs and film identification numbers also did not match up, and investigators heard conflicting statements from Miller and her co-workers.
On April 25, ACR received a letter from Miller in which she responded to instructions on how to correct the x-ray machine's deficiencies. In the letter, she claimed that she had "no prior knowledge of any discrepancies in the clinical images submitted to the ACR," and she suggested that another subordinate employee was responsible for the substituted films. ACR then notified FDA's Center for Devices and Radiological Health about the suspicious activity, prompting a criminal investigation from OCI's Kansas City field office.
On May 12, 1995, ACR issued a letter to the president of Clayton Radiology ordering him to stop using the device for mammography services. When notified by ACR of its decision, FDA terminated on May 19 Clayton Radiology's certification to perform mammography services.
Between June and July 1995, OCI's Kansas City field office investigated the allegations related to the Ausonics Alpha III unit, interviewing the informant and the company's employees. Several employees implicated the office manager in wrongdoing, leading Miller to confess July 6 in writing to substituting mammography film images in her resubmission to ACR for accreditation.
Miller was indicted Feb. 12, 1998, and pleaded guilty in June 1998 to providing false information to the government. Also charged in a separate indictment was C.R.G. Imaging. However, on Sept. 12, 1998, Judge E. Richard Webber found the company not guilty of making false statements and concluded that C.R.G. Imaging was not criminally responsible for Miller's actions.
Carol Lewis is a staff writer for FDA Consumer.
by John Henkel
A San Diego food processing company received fines totaling $1.65 million for lying about the source of more than 1.7 million pounds (765,000 kilograms) of frozen strawberries that, after being sold to the federal school lunch program, were linked to a hepatitis A outbreak in at least four states.
As part of the judgment handed down last June in the U.S. District Court for the Southern District of California, Andrews & Williamson (A&W) Sales Co. Inc. also was banned from selling produce to any federal programs and was placed on three years probation. Former A&W Sales president Frederick L. Williamson was fined $13,368 and sentenced to 10 months confinement, split between jail and home. In July, Richard Kershaw, a former A&W Sales strawberry salesman, was sentenced to five years probation and 300 hours of community service for his part in the violations.
A&W Sales pleaded guilty in November 1997 to charges of fraud and making false statements and claims about strawberries that it sold in October 1996 to the U.S. Department of Agriculture's Child Nutrition Programs. The federal agency made the fruit available to schools in several states.
Federal law requires food used in the school lunch program to be grown in the United States. A&W Sales had claimed to USDA that the strawberries were harvested domestically, but an FDA investigation showed that the fruit came from Mexico.
After tracing the strawberries to remote ranch properties near Mexico's San Quentin and Baja California Norte areas, FDA investigators determined it was possible that workers harvested the fruit under unsanitary conditions. The agency found that the strawberry fields had open-pit latrines, and workers had no ready way to wash their hands.
At least 200 Michigan students and teachers were sickened by the contaminated fruit, and about 50 other cases of sickness in other states were reported. Thousands of other students in the affected states--including Louisiana, California, Maine, and Wisconsin--received gamma globulin vaccine as a preventive measure after being exposed to strawberries linked to the outbreak.
Hepatitis A is a highly infectious virus usually spread through contact with human fecal material. It is rarely fatal, but it can cause inflammation of the liver and produce flu-like symptoms, as well as fatigue, nausea, and abdominal pain.
A&W Sales also distributed about 900,000 pounds (405,000 kilograms) of suspect strawberries to commercial outlets, which used the fruit for making dessert toppings, pies, and cocktail mixes. No known sicknesses occurred as a result of this commercial use.
The adverse publicity generated by the outbreak had a devastating impact on domestic and Mexican strawberry farmers in 1997. California producers alone lost millions of dollars that year from low sales of strawberries. The industry rebounded considerably in 1998, according to market reports.
The outbreak was first noted in mid-March 1997, when Michigan state health officials noticed a cluster of hepatitis A cases in public school students and teachers. By March 21, 89 cases had been identified, and the state called in the national Centers for Disease Control and Prevention to help locate the source. Blood tests and stool samples from patients, along with other epidemiological methods, allowed CDC to link frozen strawberries processed by A&W Sales to the outbreak.
When notified of these findings on March 27, FDA began an inspection of A&W Sales' San Diego facility. The company was not processing strawberries at the time, so the agency could not observe fruit handling procedures to determine whether processing conditions would allow for contamination. However, investigators learned from plant records that the strawberries were harvested in Mexico, and a visit by FDA investigators to Mexican fields revealed contamination possibilities.
On March 28, A&W Sales, under FDA's supervision, began a voluntary recall of strawberries from the school lunch program and from commercial distribution.
"Our initial goal was to immediately identify the distribution of the suspect lots of strawberries," says Jim Kozick, director of domestic investigations for FDA's Los Angeles district office. "Then, in a matter of days, we were able to locate and remove the contaminated fruit from circulation."
In early April 1997, FDA's Office of Criminal Investigations launched a criminal investigation of A&W Sales. Agents executed search warrants on the company's processing facility in San Diego and headquarters building near the Mexican border. Of primary interest to agents was whether brokers not employed by A&W Sales who had sold strawberries to the school lunch program knew that the fruit had not been harvested in the United States. The search of A&W Sales uncovered documents showing that the company had intentionally misled brokers into believing the fruit was of domestic origin. This evidence was a key factor in the charges brought against A&W Sales.
Salesman Kershaw had pleaded guilty May 21, 1997, to charges of misbranding food, conspiring to defraud, and making false statements. On June 10, 1997, the federal district court indicted A&W Sales and Williamson on 47 counts that included fraud, false statements, and false claims. In a final plea agreement in November 1997, the court dropped 44 of the counts, and Williamson and the company pleaded guilty to three felony charges.
A commercial food processor started acquiring the recalled strawberries on March 5, 1998, for reconditioning into preserves, jams and jellies. Because these products are processed over time and at a cooking temperature sufficient to kill the hepatitis A virus, FDA permitted the reuse and is overseeing the reconditioning operation.
Many of the Mexican growers have since taken measures to improve sanitation in the fields, FDA officials say. Though it no longer deals in strawberries, A&W Sales is still in business, processing other produce. It faces numerous other civil suits on behalf of outbreak victims and A&W Sales customers.
Oregon-based Epitope Inc. rescinded its planned acquisition of A&W Sales after the company was prosecuted, releasing Epitope from liability.
John Henkel is a staff writer for FDA Consumer.
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