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Tag No.: A1026
Based on review of the facility's policy, medical record review and interviews, the facility failed to safely administer a radiopharmaceutical isotope (safe radioactive drug healthcare providers use for special imaging tests) for 1 patient (Patient B) of 4 patients reviewed for outpatient nuclear medicine testing.
The findings include:
Review of the facility's policy titled, "Handling of Radioactive Materials," dated 1/2023, revealed "...All radiopharmaceuticals are delivered as unit doses with appropriate labels...Receive isotopes in the Imaging Department by a Nuclear Medicine Technologist...Patient identified by armband or date of birth and name...Orders checked with chart or against doctor's prescription with patient...Patient is questioned on history pertinent to the examination and recorded on the requisition...Isotope Comparison with Patient...Isotope is checked...for accuracy prior to injection..."
Review of the medical record for Patient B, dated 3/1/2024, revealed the patient was scheduled for an outpatient bone scan for Primary Malignant Neoplasm of Prostate. The scan was not performed and the medical record did not indicate why the scan was discontinued.
Review of the medical record for Patient J, dated 3/1/2024, revealed the patient was scheduled for an outpatient Hepatobiliary Iminodiacetic Acid (HIDA) scan (an imaging procedure used to diagnose problems of the liver, gallbladder, and bile ducts). The scan was not performed and the medical record did not indicate why the scan was discontinued.
Review of the Unit Dose Prescription Records, dated 3/1/2024, did not show Patient B had received a radioactive isotope. There is a label for Patient J, dated 3/1/2024, which read "...Product...Mebrofenin [radioactive isotope agent, which may be used to find and treat certain diseases or to study the function of the body's organs]...4.97 mCi [millicurie-unit of measure]...Indication: Hepatobiliary Imag. [imaging]..."
During an interview on 7/16/2024, at 2:29 PM, the Director of Radiology recalled an incident when a patient (Patient B) received another patient's isotope for a nuclear scan. The Nuclear Technician (NT) reported the incident to the Director of Radiology. The Director of Radiology was unable to recall if an internal facility incident report had been completed and the Director of Radiology stated the NT was counseled after the incident and there were no negative outcomes. The interview revealed the NT reported Patient B received another patient's isotope; it was explained to the patient the scheduled test could not be performed and would need to be rescheduled. When asked if the NT had identified the Patient B by name, date of birth, and verified the physician's order for the test, could the administration of the incorrect isotope have been avoided, the Director of Radiology replied, "possibly...yes..."
During an interview on 7/17/2024 at 10:34 AM, the NT recalled the incident involving Patient B which occurred on 3/1/2024. He stated Patient J had been scheduled for a HIDA scan and once in the procedure room, decided to cancel the scan (unsure exact reasons for cancellation). The NT stated Patient J was escorted back to the registration desk. The NT then called for Patient B in the waiting area and stated he asked for Patient B's name and date of birth while they were walking to the nuclear medicine procedure room. Patient J's radiopharmacologic isotope was still set up and had not been removed from the procedure room. The NT stated, "...I did not look...administered the wrong isotope...realized immediately once the syringe came back down what I had done..." Patient B received 5 mCi of Mebrofenin and should have gotten 20 mCi's for the scheduled bone scan. The NT confirmed he did not follow the "5 rights of medication administration" and Patient B received the wrong dose of medication.
During a telephone interview on 7/17/2024 at 1:39 PM, Patient B had the bone scan at another facility and had no negative outcomes from receiving the incorrect isotope.