The Nevada State Health Division has fined Desert Springs Hospital and Medical Center $1.14 million for more than 200 violations in its mammography department, including failing to document whether its mammogram system was operating as it should prior to some patient exams in 2007, health officials announced Wednesday.
As a result of the violations, 92 patient records were missing and the patients had to undergo additional screenings, the health division said.
The records in question, which Desert Springs officials say were misplaced, would have shown whether tests had been conducted to ensure the mammogram system was operating properly before those patients underwent mammograms, said Ed Sweeten, supervisor of the Health Division’s Bureau of Health Quality and Compliance Radiological Health Section.
The section is responsible for conducting annual inspections of Nevada’s 60 to 70 radiology programs. The inspections are conducted for the state and the federal Food and Drug Administration, Sweeten said.
Sweeten said the violations stemmed from an annual inspection conducted by his department in February, although the health division was notified by Desert Springs in late January that it “had some issues” with its records.
During the inspection, inspectors documented 228 violations that fell under seven Nevada administrative codes. The violations centered on problems in quality assurance and control as well as maintenance of records. Quality assurance and quality control documentation is used to verify the mammography department checks the X-ray machine, processing agents, darkroom, image quality and chemicals on a periodic basis.
“We’re not saying they (Desert Springs) didn’t conduct the pre-tests, but they do not have the records showing proof that they did,’’ said Sweeten, a radiation physicist. “In health care, if it’s not documented you can’t say it was done. It is a violation if you don’t show proof.’’
During the inspection, and after reviewing patient records, it was determined the mammography department did not have documentation for its pre-testing of the X-ray machine between April 30 and Sept. 21, state health officials said.
One of the checks involves producing an image of a “phantom” breast • a square block that mimics a breast. This test is conducted to ensure there are no photographic issues with the X-ray such as problems with density or contrast, he said.
“If the test isn’t conducted and, let’s say there is a speck of dust in the machine, it could impact the diagnostic interpretation of a patient’s film,” Sweeten said. ”Something as small as a speck of dust can look like a micro calcification which is the beginning of cancer. That speck of dust could lead to someone having further work-up, such as a biopsy, when possibly this shouldn’t be happening.’’
After the inspection, a sampling of the patients’ films were sent to the federal agency for review. About half of the samples had issues with contrast, technique and positioning, Sweeten said.
Also, documentation that would verify daily cleaning of the darkroom and the area where mammograms are conducted had not been done “at the desired frequency.” Check lists were blank in a four-month period.
The hospital was then notified that the state would be issuing a Notice of Intent to deny renewal of the hospital’s certificate to conduct mammograms. The settlement was agreed upon, which allowed the program to continue.
Hospital officials wouldn’t say how the records ended up missing but noted in a press statement that, based on an internal investigation as well as a review by the American College of Radiology, it is believed the quality assurance checks were indeed conducted.
The statement went on to say that the hospital believed the “mammography equipment was functioning properly, and all studies were of appropriate diagnostic quality from an equipment perspective.’’
Although state officials said 92 patients had to be re-tested, the hospital arrived at a different number. It said
Sweeten said in reviewing the hospital records, the lack of records “just stopped’’ going back to April 30, 2007, which is how the health division determined the number of patients who needed re-testing.
The fine, the largest ever handed down by the section, comes to $5,000 for each of the 228 violations, Sweeten said.
Under the agreement, Desert Springs agreed to pay the state’s Health Division $228,000. The remaining portion of the fine, $912,000, will be settled over time. To do so, the hospital has agreed to provide community services such as:
• Provide free mammograms for one year to male and female patients age 40 and 50 and who require financial assistance and lack health insurance. Patients who qualify for the Women’s Health Connection are also eligible.
• Provide mammograms at no charge to patients in May “in honor of Mother’s Day and in October in honor of Breast Cancer Awareness month.”
• Provide free seminars and education on the importance of annual mammography screenings and have a presence at community health fairs to increase breast cancer and mammography awareness.
• Provide a list of physicians who may accept Medicaid or offer charitable care in cases where follow-up care is needed beyond screenings.
According to the health division, Desert Springs also must outline and detail the duties of a mammographer that adheres to state and federal regulations, submit quarterly quality control and quality assurance records, and prepare and maintain a self-reporting policy that notifies the Radiological Health Section within 10 days of any violations.
Desert Springs is also subject to monitoring by the health division the upcoming year to ensure corrective actions have been implemented, officials said.
Sweeten said this is the first time a facility that provides radiology services has been slapped with such a fine.
However, he said, “it doesn’t make anyone bad.’’
“In all honesty, Desert Springs has an excellent program,’’ he said. “There was a lapse there and the staff has changed.’’
Contact reporter Annette Wells at email@example.com or 702-383-0283.