A California hospital where a 2-year-old child received a massive overdose of radiation during a series of CT scans has been hit with a $25,000 fine by state regulatory authorities, who found that the facility did not follow its own written policies and procedures regarding radiation safety.
The California Department of Public Health (CDPH) in Sacramento assessed Mad River Community Hospital in Arcata with a $25,000 administrative penalty for what the agency said was the hospital's failure to follow its own written policies and procedures regarding radiation safety and use of the lowest possible radiation dose.
The administrative penalty was issued after a state investigation determined that the hospital was not compliant with state licensing requirements that caused, or were likely to cause, serious injury or death to patients, according to a CDPH press release issued March 3, 2009.
The penalty was issued as a result of an improperly performed CT scan of the cervical spine on 23-month-old Jacoby Roth on January 23, 2008. A CT technologist acquired 151 CT scans over a 65-minute period, according to Roth's parents, who were present in the CT suite
Roth received an estimated radiation dose of 2.8-11 Gy, according to a report prepared by the medical physicist of the hospital, an amount that has increased his risk of developing a fatal cancer during his lifetime. The dose Roth received compares to a range of 1.5-4.0 mSv for a "normal" pediatric CT study of the entire spine, according to pediatric imaging experts.
A report issued by the CDPH provides a number of details regarding the incident. The report was based on an investigation conducted on May 27 and 28, 2008, by Beverly VandeWeg, a CDPH health facilities evaluator nurse.
According to the report, Roth had been admitted to the emergency department for a possible neck injury resulting from a fall out of bed the previous night. The attending emergency physician ordered an x-ray of his spine, which revealed that the patient had a C2-C3 subluxation. The physician then ordered a CT exam to rule out any injury to the cervical spine.
The CT exam was initiated at 8:32 a.m. and completed at 9:37 a.m., according to radiology department documentation. Roth received 151 scans in the same section of the midmaxillary sinuses, midclivus, and posterior fossa. The CT technologist notified the emergency department physician that the images were unclear. A second CT scan was performed by a different CT technologist, starting at 10:55 a.m. and ending at 10:56 a.m.
Photographs of the child provided by the hospital to VandeWeg showed redness on the patient's left and right cheeks. The photographs of the left side of the patient's face showed a clear line that extended from the infraorbital ridge backward through the ear and nape of the neck. A similar line extended from the infraorbital ridge through the ear on the right side. The lines were consistent with the anatomical region that received excessive radiation, representing a plane approximately 3-mm thick, according to VandeWeg.
The written report of the hospital's medical physicist stated that he calculated the absorbed dose to be 2.8 Gy and possibly as high as 11 Gy. Using relevant material from the article "Estimated Risks of Radiation-Induced Fatal Cancer from Pediatric CT," published in the American Journal of Roentgenology (February 2001, Vol. 176:2, pp. 289-296), the physicist indicated that Roth had a lifetime increased risk of a fatal cancer of 39%.
In her investigation, VandeWeg interviewed Raven Knickerbocker, the CT technologist who performed the initial scan, the unnamed CT technologist who performed the second scan, the former imaging department manager, and the interim imaging department manager.
Knickerbocker said she programmed the CT scanner to C-spine level C1 through C4 and acquired two images, after which an error number for the exam table position became visible on the computer screen. After readjusting the table and noting that a parent was leaning on it to keep the patient from moving, she reset the program, noticed an error number for the table, and again reset the table, asking the parent not to lean on it.
Knickerbocker manually programmed the CT console with the appropriate protocol and pushed the exposure button a total of four times. She then put the program into helical series and continued the CT scan, but saw only two images. At that point, she said she called another CT technologist for assistance and asked that the department manager be telephoned.
VandeWeg notes in her report that the statement provided by Knickerbocker in the interview was inconsistent with a written statement she prepared on January 30, 2008. In that statement, she said she saw an error on the control panel, and the CT scanner would only allow her to scan axial slices. As a result, she stated she had to scan each slice, waiting each time for the image to be reconstructed and the x-ray tube to cool. She stated that the CT scanner would not allow her to change the protocol parameters or override them.
Medical record documentation prepared by a hospital radiologist also contradicts Knickerbocker's statements. The radiologist reported that "it appeared likely that the technologist involved did initiate each of the 151 scans with a separate push of the scan button." A similar statement was prepared by the individual who was the manager of the imaging department at the time.
Knickerbocker asked the other CT technologist to redo the CT scan, saying that she could not get good images because the child moved during the procedure, according to a statement made by the second technologist during her interview. She said she was able to persuade the child to remain still and acquired 25 slices in approximately 60 seconds. She told VandeWeg that she was "horrified" after seeing the images of Knickerbocker's exam and immediately notified the imaging department manager.
The manager of the imaging department in January 2008 told VandeWeg that he had interviewed Knickerbocker and that she did not have an explanation of her actions. He stated that he believed the case was an incident of operator error and documented it on February 4, 2008, noting that the hospital's ALARA (as low as reasonably achievable) radiation dose policies for acceptable levels of radiation had been violated.
He stated -- and preventive maintenance records confirmed -- that the CT scanner was working properly and had a maintenance check on December 6, 2007. This individual was not employed by the hospital when he was interviewed by VandeWeg.
Plan of correction
In addition to administering the fine, the CDPH required that a plan of correction including the following items be implemented by January 9, 2009:
- Development of an ALARA educational in-service and competency validation tool, administered to each radiology technologist on staff and to newly hired technologists
- Specific ALARA recommendations for pediatric patients
- Reminders to technologists that expert resources are available to assist with CT exams
- Yearly review of ALARA philosophy with staff, and documented revalidation of competency as part of annual evaluation
- Maintenance of records about ALARA competency validation for all clinical staff
Knickerbocker has appealed the suspension of her license to practice as a radiologic technologist in any capacity in California. The case is awaiting a hearing while she retains a new attorney to represent her, said Ralph Montano, an information officer with the CDPH. The suspension will continue indefinitely unless rescinded by a state administrative law judge.
Don Stockett, the attorney for the patient, told AuntMinnie.com that Mad River Community Hospital has not approached him to discuss negotiating an out-of-court settlement. He is in the process of taking depositions and said that no court date for a trial has been set.
Mad River Community Hospital contends that it did not violate the conditions of its state licensure, and it plans to appeal the $25,000 fine, according to a statement issued by the hospital.
By Cynthia E. Keen
AuntMinnie.com staff writer
March 24, 2009
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