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Medical Events FY24 ACMUI Presentation
	ML25162A113
Person / Time
Issue date:	04/07/2025
From:	Dimarco D; NRC/NMSS/DMSST/MSEB
To:	;
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	Download: ML25162A113 (1)
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Status of Medical Events FY 2024 Daniel DiMarco Medical Radiation Safety Team April 7, 2025

Purpose of Medical Event Reporting Medical event reporting helps to identify deficiencies in the safe use of radioactive material and ensures that corrective actions are taken to prevent recurrence.

A medical event may indicate a potential problem in a medical facility's use of radioactive materials.

It does not necessarily result in harm to the patient.

Medical event reporting allows the NRC to determine if other licensees might be experiencing the same or similar challenges.

The NRC assesses trends or patterns, identifies generic issues or concerns, and recognizes any inadequacy or unreliability of specific equipment or procedures.

2

Immediate Reporting Requirements A written report must be submitted within 15 days after discovery and must include Licensees name Name of prescribing physician Brief description of event Why the event occurred The effect, if any, on the individual(s) who received the administration What actions, if any, have been taken or are planned to prevent recurrence Certification that the licensee notified the individual (or the individuals responsible relative or guardian), and if not, why not.

Report should not include patient's name. Separate annotated copy of the report should be provided with patient name, identifying number, and copy of annotated report to referring physician.

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Reporting Best Practices The NRC uses medical event reports to look for trends and generic issues.

Provide enough detail that an uninvolved individual would have a full understanding of the event.

Do not assume the reader knows all associated regulations or current standard protocols.

Helpful details include:

Manufacturer, model, or specifications of supporting equipment associated with the event such as IV pump or gauge size.

Relevant information that preceded the event.

What staff was present.

How the event was identified.

Include short and long term corrective actions and how they are linked to the event.

Clearly highlight if the event or corrective actions involve a common industry-wide practice or procedure.

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Medical Events FY 2019 - 2024

The total number of patients involved if greater than the number of reports 5

FY19 FY20 FY21 FY22 FY23 FY24 35.200 1 (8*)

0 4

0 1

0 35.300 9

2 10 10 11 7

35.400 5

6 4

1 3

1 35.600 9 (10*)

13 5

11 (40*)

8 6

35.1000 32 27 41 34 36 34 Total 56 48 64 56 59 48

Medical Events 2024 35.300 Medical events 7

Ra-223 2

Lutetium-177 3

I-131 2

6

7

Patient Underdose [240289]

- Prescribed 3.3 MBq (89.2 µCi), administered 1.68 MBQ (45.53

µCi)

- Medical physicist deviated from written directive procedure to measure the activity in the dose calibrator and then deliver the dose

- MP delivered the dose after adjusting using an outdated and incorrect formula

- State initiated an investigation 35.300 Ra-223

8

Patient Underdose [240289]

- Prescribed 3.37 MBq (91.2 µCi), administered 2.68 MBq (72.46

µCi)

- Medical physicist deviated from written directive procedure to measure the activity in the dose calibrator and then deliver the dose

- MP delivered the dose after adjusting using an outdated and incorrect formula

- State initiated an investigation

- Same patient as previous event (2 doses with 2 separate WDs one month apart) 35.300 Ra-223

9

Patient Overdose [240075]

Patient prescribed 3.7 GBq (100 mCi), received 7.4 GBq (200mCi)

Original WD called for 7.4 GBq but oncologist had signed a dose alteration plan for 3.7 GBq Alteration was not captured in the WD modification, and the full dose was delivered Multiple root causes were identified, including changes in dose not being seen, not all employees having access to the patient electronic medical records, unavailability of reduced dosage ordering and a lack of dual sign off by Infusion Nurse and Nuclear Medicine staff No adverse effects are expected Corrective actions included WD completion closer to the actual therapy, creation of a reduced dose order in electronic records, inclusion of dual verification of dose, and discussion of reduced dose directly with the AU 35.300 Lu-177

10

Patient Overdose [230483]

- Patient prescribed 5.55 GBq (150 mCi), received 7.4 GBq (200 mCi)

- Patient was unintentionally administered the full dose, rather than the reduced dose

- Root cause was determined to be lack of WD review and lack of timeout use before the procedure

- No adverse effects are expected

- Corrective actions included a review of the WD format and improvement of the two-technologist pre-treatment timeout procedure

- Additional actions included reeducation stressing the importance of the pre-treatment timeout and attention to detail 35.300 Lu-177

11

Patient Underdose [240041]

- Prescribed 7.4 GBq (200 mCi), administered 5.54 GBq (149.7 mCi)

- Treatment went as planned; a survey meter positioned to monitor the vial determined that activity had been delivered to the patient

- Post-treatment survey noted a residual activity of 1.62 GBq (43.7 mCi)

- Investigation determined that due to changes in the licensee supply chain, a new IV set was being used

- This new set did not have a clip to prevent backflow into the pump, which resulted in a visual constriction of the IV line

- Technologist attempted to open up the tubing, which seemed successful after manipulation

- Corrective actions included changing the procedure for infusion and repositioning the survey meter to more directly measure the activity in the vial 35.300 Lu-177

12

Patient Overdose [230491]

- Patient prescribed 3.7 GBq (100 mCi), received 5.92 GBq (160 mCi)

- Root cause was determined to be human error

- NMT misinterpreted sloppy handwriting by the AU on the WD and the AU failed to confirm the dose during the pre-treatment phase of the administration

- Additionally, more minor discrepancies on the WD indicated a lack of oversight by the RSO

- Adverse effects included an increased cancer risk due to an additional whole body dose of approx. 62 rem

- Corrective actions included procedure updates for WD (including typing of prescribed dose), additional training for Aus on WDs, and more frequent RSO audits of WDs 35.300 I-131

13

Patient Underdose [240143]

Prescribed 3.7 GBq (100 mCi), administered 0.148 GBq (4 mCi)

When performing routine radiation surveys at the end of the day the licensee found the 3.7 GBq capsule in its original packaging Determined that the patient had only been given the diagnostic capsule Root cause was determined to be a lack of dose confirmation on the written directive prior to administration Corrective actions included education of NMTs on proper patient and activity processing Additionally, procedures were revised to provide clarity on NMT responsibilities 35.300 I-131

Medical Events 2024 35.400 Medical events 1

Cs-131 (GammaTile) 1 14

15

Patient Underdose [240198]

- Prescribed 6,000 cGy (rad), received 3,600 cGy (rad)

- 40 seeds successfully implanted in the brain for treatment

- Patient returned due to medical complications and had the seeds removed over two procedures

- Seven seeds were lost post-explantation, state conducted an on-site investigation

- Corrective actions included additional training for neurosurgery staff 35.400 GammaTile

Medical Events 2024 35.600 Medical events 6

HDR 6

16

35.600 HDR

Patient Overdose [230454]

- 218.49 GBq (5.905 Ci) Ir-192 HDR unit

- Prescribed 3,400 cGy (rad) over 10 fractions, received 4,420 cGy (rad)

- Dwell times were not verified between planning and delivery systems for 8 fractions before being identified

- Delivery system was on a Windows XP based personal computer that could not be on the licensee network due to security reasons

- This configuration prevented communication between the planning and delivery systems, resulting in incorrect dwell times

- No effects were noted to the patient, treatment was considered completed 17

35.600 HDR

Patient Overdose [230436]

- Expected dose to non-target organ was 200 cGy (rad),

delivered 340 cGy (rad)

- First fraction of treatment was delivered for management of cervical cancer when the error occurred

- Follow-up determined that HDR channel assignments had been reassigned during setup mistakenly, followed by a failure to confirm proper channel assignment during the pre-procedure timeout 18

35.600 HDR

Patient Overdose [230436] (cont.)

- Patient proceeded with the rest of the treatment successfully, with no additional effects from the overdose

- Corrective actions included retraining HDR staff on applicator configuration and verification of channel connection

- Additionally, the licensee considered the use of different lengths of transfer tubes for different channels to physically distinguish it from other channels 19

35.600 HDR

Patient Overdose [230517]

- Patient was prescribed 236.8 cGy (rad), received 362 cGy (rad)

- Patient was scheduled to receive treatment but was mistakenly administered the first fraction of a previous patients treatment

- Physicist set up the new patient in the HDR vault and confirmed that the patient was correct, without closing the previous treatment plan

- Physicist closed the previous treatment plan after exiting the vault

- Physicist then inadvertently re-opened the previous treatment plan and delivered the first fraction to the wrong patient 20

35.600 HDR

Patient Overdose [230517] (cont.)

- Physicist caught the error once they tried to upload the post-treatment summary and noticed there was one already completed

- Dose evaluation was completed, and the remaining 9 fractions were changed to compensate for the overdose, resulting in a final dose only 2% below the original treatment plan

- Corrective actions included modifications to the patient check in procedure, additional sign offs on the console treatment plans, and another verification to ensure the computer treatment plan and the prescribing computer plan match regarding the active patient 21

35.600 HDR

Wrong Site [230461]

- Patient prescribed three treatments of 550 cGy, total of 1,650 cGy (rad) to the uterus

- During the third fraction, treatment was interrupted due to fluid in the transfer tubing

- Replacement tubing was not the correct length, resulting in the source being outside of the patient for 10 seconds

- Localized skin dose to the patients thigh was estimated to be 300 cGy (rad) in a worst-case, direct contact scenario and 50 cGy (rad) for a more realistic, 8mm distance scenario

- Physician noted that the dose was below the level likely to cause injury 22

35.600 HDR

Wrong Site [230461] (cont.)

- Delivered dose during this fraction was within 20% of the expected dose to the uterus

- Corrective actions included leak testing tubing and revision of procedures to verify tubing length before starting treatment

- Additionally, new procedures were developed for interruption of treatment to adjust patient setup 23

35.600 HDR

Patient Underdose [240081]

- 438.82 GBq (11.86 Ci) I-192 HDR Unit

- Prescribed 600 cGy (rad) fractions, received 100 cGy (rad) for the third treatment

- Dwell positions with two ovoid applicators was successful, but was obstructed with the tandem applicator

- Repeated checks and attempts were unsuccessful, leading to the underdose

- Investigation of the applicator found microfractures in the tandem

- Licensee noted the matter seemed to be related to the autoclaving process for the applicators

- Corrective actions included applicator replacement and development of additional precautionary safety procedures

- Patient treatment was revised and successfully completed 24

35.600 HDR

Patient Underdose [240044]

- 236.06 GBq (6.38 Ci) Ir-192 HDR unit

- Patient prescribed 550 cGy (rad) per fraction, received 60.5 cGy (rad)

- Treatment time was determined to be six minutes and 15 seconds over nine dwell positions

- After starting treatment, timer froze at six minute and seven seconds

- Physician stopped the treatment once the freeze was noticed, estimating the treatment time to be around 30-40 seconds

- Investigation found that the device was functioning normally, and the timer freeze was unable to be replicated or verified

- Licensee paused their HDR program until more troubleshooting could be performed 25

Medical Events 2024 35.1000 Medical events 34 GSR 1

Y-90 Microspheres

- Unknown 3

- TheraSphere 27

- SIR-Spheres 3

26

35.1000 Gamma Stereotactic Radiosurgery

Wrong Site [240018]

- Patient was prescribed 80 Gy (8000 rad) to the left trigeminal nerve, delivered full dose to the right trigeminal nerve

- MP misidentified the nerves during pre-treatment and the reviewing neurosurgeon and oncologist did not notice the error during the plan review

- No adverse effects are expected

- Corrective actions included implementation of new procedures for GSR procedures, additional peer reviews by a gamma knife trained oncologist, and a verbal timeout before all cases.

- The state conducted a follow-up investigation and had no adverse findings from the inspection, closing the investigation 27

35.1000 Y-90 Microspheres

Patient Overdose [240113]

- Patient prescribed 2.6 GBq (70 mCi), delivered 3.13 GBq (84.5 mCi)

- Technologist drew up 3.17 GBq (85.8 mCi)

- Treatment was delivered within 30 minutes of the dose being drawn

- Incident was discovered during a quarterly review a month later

- Both AU and patient referring physician were satisfied with the activity delivered 28

35.1000 Y-90 Microspheres

Patient Underdose [240351]

- Prescribed 14,700 cGy (rad), received 5,880 cGy (rad)

- Licensee suspected stasis 29

35.1000 Y-90 Microspheres

Patient Underdose [240092]

- Patient received 30% of prescribed dose

- When inserting the catheter, vein contusions caused the underdose to occur

- Licensee noted the incident did not cause stasis 30

ML25162A113

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