A medical mistake by CoxHealth put dozens of cancer patients at risk. Doctors gave many of them too much radiation. We're learning more about what went wrong. CoxHealth's president says the patients at risk had difficult to treat cancerous or non cancerous brain tumors that needed a radiation beam. They say the first time they set up the equipment at the in 2004, the physicist didn't do it right. The families of 76 people are questioning if a physicist's error negatively impacted theirs. "Many patients had very serious tumors and had poor prognosis when they began treatment," Dr. John Duff, Senior Vice President of CoxHealth’s Hospital Services said at Wednesday’s news conference. Duff says a new physicist hired by CoxHealth put their treatment from a BrainLAB stereotactic radiation therapy under the microscope. He says the first physicist who calibrated the system in 2004 chose the wrong measurement that sent up to 50% more radiation into patients. Forty-eight of the 76 patients overexposed are dead. An investigation is underway to see what impact the overexposure had on each person. The physicist no longer works for the hospital. "He was board certified, he was well trained and had about 30 plus years of experience," CoxHealth President and CEO Robert Bezanson said. KSPR spoke to a physicist not connected to CoxHealth about radiation safety and risks. At competing hospital St. John's cancer center, they say they run quality assurance checks every day. They send radiation into a “phantom skull,” a plastic skull similar to human tissue, they check film inside the skull to see how accurately the radiation hit the target. They use a different technology than CoxHealth called CyberKnife. "With CyberKnife a robotic arm targets an area through the arm,” St. John’s Chief Physicist Dr. Dennis Frieda said. “The BrainLAB system is based on the conventional linear acceleration that rotates around a fixed axis." St. John's medical physics team says in house checks aren't enough. Each year they send their radiation calibrations to the M.D. Anderson Cancer Center for an outside test. "We expose and treat to a set dose. We send them how much we think we gave and they tell us what they think," Frieda said. CoxHealth says only the first physicist checked his calibration. After discovering the problem and an internal investigation, an outside group is monitoring all critical equipment. "It's totally unacceptable an error occurred,” Duff said. “We intend that it will not occur in the future." Symptoms of over radiation include headaches, slurred speech and memory loss. Doctors say reactions depend on how close the radiation was dosed to critical parts of the brain including the brain stem or optic nerves. KSPR called BrainLAB. Its marketing and communications manager issued this statement: "Our sympathies go out to all of the patients involved at CoxHealth. BrainLAB assisted CoxHealth immediately upon being informed. Reviews determined that BrainLAB equipment performed as designed and did not malfunction. We will continue to closely monitor this situation and provide any technical assistance necessary." KSPR asked if any other hospitals had similar issues or if other patients have received increased radiation. As of 6:30 Wednesday night, we have not heard back. Here is the statement CoxHealth issued: Springfield, MO - CoxHealth today announced that it has discovered that 76 patients who had received a very specific type of treatment for brain tumors and other difficult-to-treat conditions using its BrainLAB stereotactic radiation therapy system, were accidentally exposed to radiation in amounts that exceeded the intended, therapeutic dose. The average variation of all the treatments of the 76 patients exceeded the prescribed dose by approximately 50 percent. A variation on the delivered dose of up to 10 percent is not significantly different than the prescribed dose and is considered no more risky than the prescribed treatment. The BrainLAB stereotactic system utilizes a high dose of precisely targeted radiation to be delivered to smaller areas within the brain and other organs in the body, minimizing damage to surrounding tissues. This treatment is called stereotactic radiation therapy. "In the simplest of terms, when the BrainLAB stereotactic system was put into service in 2004, we believe that the CoxHealth chief physicist responsible for initially measuring the strength of the radiation beam and gathering the data used to calibrate the equipment, chose the wrong measurement device - called a chamber," said John Duff, MD, senior vice president of hospital operations. "The area radiated is called the 'field size.' For these small tumors, the area radiated is referred to as a 'small field size.' The calibration error affected those patients who had treatment of very small field sizes." "This is a very complex process, and unfortunately in spite of this physicist's experience and training, an error was made," said Duff. "We are deeply sorry for our error and how it has affected these patients and their families. CoxHealth takes full responsibility and is doing all we can to care for and support our patients and their families," said Robert Bezanson, president and CEO of CoxHealth. The chief physicist who made the initial calibration error is no longer working for CoxHealth. "Because no patients during this time period were observed to have symptoms of increased radiation exposure, there was no prompt for CoxHealth to investigate any possible problems. It was only when a second CoxHealth physicist received training on BrainLAB stereotactic treatment in September 2009, did it enable us to question if the initial programming calibration was calculated correctly. At that point, we stopped accepting new patients into the BrainLAB stereotactic program, and began an internal investigation," said Duff. "We knew we needed to re-measure the strength of the radiation beam in order to ensure that the radiation doses given to future patients were correct, and to calculate the actual doses previously received by our patients. We re-measured and recalibrated the BrainLAB stereotactic equipment and confirmed that the machine was recalibrated correctly for all treatment field sizes, with the exception of the very small treatment field sizes - 1.1 cm and smaller, or about the size of a pea. Because of these findings, we were comfortable resuming BrainLAB stereotactic treatments with the larger treatment field sizes," Duff continued. "Therefore, we resumed treatments for larger field sizes in November 2009. However, because of our desire to err on the side of caution, we hired an outside physics group to confirm our internal measurements and recalibration of the BrainLAB stereotactic equipment. This group agreed with our calibrations and helped us examine and resolve our questions about the small field treatment sizes. This gave us the verified calibration data to begin our recalculation of past patients' doses. It was at this time that we found several cases where the variance between the radiation dose received, and that prescribed, had exceeded the amount we considered to be in the therapeutic range." "We immediately suspended the BrainLAB stereotactic program for all patients, and to determine the actual amount of radiation received, we hired an outside physics expert to begin an independent re-analyses of all 152 patient cases treated in the BrainLAB stereotactic program since its start in 2004. We received the majority of the results on Feb. 16, and immediately began calling patients to request in-person meetings to notify them of their results. Again, we did not accept any new patients requiring small field size treatments, after our first suspicions in September 2009," said Duff. In addition to the 76 BrainLAB stereotactic patients who received treatment that exceeded the prescribed dose by 10 percent or more, CoxHealth believes that the remaining 76 received exposure that was considered to be within the therapeutic range. These 152 patients are the sum total of all patients treated by the BrainLAB stereotactic equipment since its start in 2004, and they constitute only about one half of one percent of the total radiation oncology treatments performed by CoxHealth. "It is important that our patients and the community understand that our error was isolated to only our BrainLAB stereotactic treatments. The vast majority of our patients in radiation oncology receive external beam radiation treatments, which are different than BrainLAB stereotactic treatments. The BrainLAB stereotactic system error also has no relation to the routine diagnostic tests we perform every day that use radiation, such as X-rays and computed axial tomography (CT) scans, nor does it affect any other cancer or related treatments involving radiation. Many patients receive other types of radiation treatment at CoxHealth; the BrainLAB stereotactic equipment calibration error is isolated to one very specific type of radiation treatment for a small category of brain tumors," said Bezanson. What CoxHealth has done as a result: • Since it received the results of the independent expert's analysis, CoxHealth has attempted to contact by phone or letter (if phone contact has been unsuccessful) all patients to notify them of the error and explain its plan for taking full responsibility. CoxHealth has attempted (and is attempting) to have in-person meetings with as many patients and families as possible. It is also in the process of contacting the families of deceased patients to provide them with the same information. "We were unable to complete our notifications to all patients and families before the media inquiry we received, although that was our plan," said Duff. "It's simply the right thing to do. Our intent was to always do a public announcement after speaking to and assisting our first priorities - our patients. " • CoxHealth has also communicated with the patients who received radiation within what is considered the therapeutic range. • In the cases of patients who have died, CoxHealth has attempted (or is in the process of attempting) to meet with or communicate with their family members. In many of the cases, the tumors these patients had were very serious, and many of the patients had a poor prognosis when they began this treatment. CoxHealth's review of patient records is ongoing and not yet complete, so they indicate that it is premature to say if the overexposure had any impact on their current health condition, or if deceased, if it had any contributing factor to their deaths. • CoxHealth has also dedicated a special team of nurse coordinators to assist patients and families of patients who have received the BrainLAB stereotactic therapy and who may have questions or need assistance. They have established a call center line for them at 417-269-5363 or an e-mail contact at firstname.lastname@example.org. • CoxHealth will pay for all additional follow-up exams, testing, support and treatment recommended by the affected patients' radiation oncology physicians, as a result of the overexposure they've received. • CoxHealth has implemented a special Safety Assurance Technology initiative as a result of this situation and has reached out to agencies interested in improving radiation safety and reporting. "Our BrainLAB stereotactic system remains suspended indefinitely while we are auditing the entire program. We have also taken this situation to heart. It's unacceptable to us that an error like this occurred and we are taking steps to make sure that an error like this doesn't happen again," said Bezanson. "Therefore we have implemented a system-wide "Safety Assurance Technology" initiative, in which we are checking - and double-checking - ALL of the technology and equipment used in not only the radiation oncology department, but also our radiology and surgical services. These three areas are where most of our life-saving technology is concentrated, and we want to assure our patients and ourselves that an inadvertent human error won't impact people in this manner again." "We also have reported this incident to the national hospital accreditation agency, the Joint Commission. There is no federal agency, nor is there any agency in the state of Missouri that requires reporting of radiation overexposure. Some states have reporting agencies and others do not. Missouri does not," he said. Duff said, "This is a very complex area of technology. We are going to reach out to the Food and Drug Administration, even though there is no one there to disclose to, offering our support of their initiatives to strengthen radiation reporting and safety. We also will attempt to work with our lawmakers and other hospitals that have been faced with similar situations to see how we can be a part of the solution to prevent this from happening to other hospitals and patients in the future." Bezanson concluded, "In closing, we know that our radiation oncology service provides life-saving treatments to hundreds and hundreds of patients each year, and there are many who can say, 'CoxHealth saved my life.' We are committed to ensuring beyond a doubt, that this program, and our many other services that use the most complex of life-saving technology, are safe, and will continue to be, in the future." 1. How could this have happened? Don't you have someone double checking radiation therapy doses? The chief physicist who did the data collection and initially programmed the equipment did so after receiving BrainLAB stereotactic radiation training. The BrainLAB representative was present with the chief physicist during the commissioning of the equipment, which gave us a sense of confidence that we had set up the system correctly. The chief physicist used his training, experience and judgment to choose a measurement device to measure the strength of the radiation beam. Unfortunately, he chose the wrong device. It doesn't excuse what happened, but it might make it easier to understand. It was only after a second physicist was trained on BrainLAB that it gave us collectively a second viewpoint and the prompt to check the initial measurement device used. Also, because no patients during this time period were observed to have unexpected symptoms of increased radiation exposure, there was no prompt for CoxHealth to investigate any possible problems. 2. How come this took so long to discover? Why didn't you know sooner? Once the wrong chamber was selected to initially calibrate the machine, the same wrong chamber would have been used to check the equipment that delivered the radiation. This caused the results of our checks to show that the equipment was properly calibrated. It was an initial error, which, unfortunately, for some time continued to impact a group of patients who required treatment of a small area (or "field size"). We began communicating with affected patients and families as soon as we knew for certain that we had a problem and had confirmed which patients and to what extent. And it was always our intent to announce this publicly after we had talked our patients and families. 3. Was the equipment double checked and how can people be assured that every other machine and procedure that uses radiation is checked and double-checked for safety? What are CoxHealth's procedures to double check for human and mechanical errors? CoxHealth has processes in place to monitor total quality assurance for equipment as recommended by the manufacturer. However, this error occurred not because of a problem we had with the operation of our equipment, it occurred because the chief physicist chose the wrong measurement device. We did conduct routine checks on the equipment that delivered the radiation, and we did follow the standard requirements. Again, the problem was in the chief physicist's selection of the wrong measurement device. Because that same measurement device would have been used to conduct checks of the equipment, we always got the same answer. We are implementing additional safeguards to go beyond the standard requirements. We are applying the lessons learned from this incident to all high risk equipment/procedures to be certain additional safeguards - including double-checks - are in place. We have taken this isolated incident to heart: CoxHealth has implemented a special Safety Assurance Technology initiative as a result of this situation and has reached out to agencies interested in improving radiation safety and reporting. We are checking - and double-checking - ALL of the technology and equipment used in not only the radiation oncology department, but also our radiology and surgical services. These three areas are where most of our life-saving technology is concentrated, and we want to assure our patients and ourselves that an inadvertent human error won't impact people in this manner again. All higher-risk equipment is being examined to be certain appropriate safeguards - including double-checks - are in place. 4. Are you bringing in an outside authority on these machines and procedures to double-check that they are working properly? Yes, during our investigation outside firms were brought in to review the operation and calibration of our equipment, and to confirm that it is safe for our patients. We will continue this practice as a future safeguard. In the case of diagnostic radiology equipment, this routine outside review is already in place (for example X-rays and CT scanners). 5. Are people being trained/retrained on the BrainLAB stereotactic radiation equipment? Yes, as part of our plan, individuals will be receiving additional training in a range of areas. We have already provided additional training to a dosemitrist (the person that assists the physicist and radiation oncologist in planning a patient's radiation treatment) in the radiation oncology department, who will be assisting with future BrainLAB treatment plans. We are also in the process of recruiting additional physicists who will receive specific BrainLAB training. We are writing more definitive policies and procedures around the BrainLAB operation, and we will ensure that equipment checks are continued and double-checks will be conducted by an outside, independent group. 6. What about the scenario of under-dosing? For example, are there patients who didn't receive enough radiation as a result of the error? No. 7. How did you tell the patients? How are you handling these cases? We made a commitment to try to tell as many of the patients and their families in person, or if they didn't want to or couldn't come in, by telephone. We felt that this was the right way to handle this communication. Most of the patients have expressed their gratitude that they heard the news from us first rather than from a second-hand source. For those people we couldn't reach by phone, we have sent letters explaining their situations briefly and encouraging them to contact us. 8. Explain which types of cases are typical candidates for this kind of radiation treatment. If radiation is complex and dangerous, is it the only option in all of these cases? In the case of the BrainLAB treatments, the candidates were typically patients with cancerous and non-cancerous brain tumors that were more difficult to treat and needed the type of radiation "beam" created in stereotactic radiation treatment. Many of their tumors were surrounded by delicate brain tissue and so this type of treatment was considered ideal since the pinpoint beam had a lesser chance of damaging surrounding tissue. Other treatments may have included surgical intervention, and in some cases, patients did have surgery. 9. What are the symptoms of over-radiation for these types of tumors? Side effects of radiation delivered to patients with brain tumors can include headaches, slurred speech and memory loss. Typically, it can take several months to a year for these symptoms to emerge. 10. How will you work with patients to pay for any care necessitated by this situation? Patients start the review of their case and assessment of their health with their radiation oncologist. We have also involved their referring physicians, in most cases, a neurosurgeon, and we are paying for all of these services. In short, we will pay for all exams, testing or treatment recommended by the patient's radiation oncologist. 11. When will the program be up and running again? Where are patients who need treatment going now? We are undertaking a very thorough analysis, and our BrainLAB stereotactic system remains suspended indefinitely while we are auditing the entire program. We want to be able to assure physicians and patients, when we bring it back into service, that it is absolutely and totally safe for use. 12. How many people receive radiation treatment at Cox every year? In total, approximately 1000 people received radiation oncology treatments in 2009. So again, the 152 patients who had received BrainLAB stereotactic radiation therapy between late 2004 and late 2009 were, by contrast, a very small percentage. Only about one half of one percent. 13. If people have questions or concerns, what can they do? CoxHealth has dedicated a special team of nurse coordinators to assist patients and families of patients who received the BrainLAB stereotactic therapy and who may have questions or need assistance. They have established a call center line for them at (417) 269-5363 or an e-mail contact at email@example.com.