ML25084A168
| ML25084A168 | |
| Person / Time | |
|---|---|
| Issue date: | 02/12/2025 |
| From: | Advisory Committee on the Medical Uses of Isotopes, NRC/NMSS/DMSST |
| To: | |
| References | |
| Download: ML25084A168 (3) | |
Text
U.S. Nuclear Regulatory Commission (NRC)
Advisory Commiee on the Medical Uses of Isotopes (ACMUI)
Subcommiee on Development of a Generic Process Checklist to Help Reduce Medical Events Dra Report Submied: Feb 12, 2025 Subcommiee Members Richard Green, BS Pharm (chair)
Rebecca Allen, MS Richard Harvey, DrPH Hossein Jadvar, MD, PhD Melissa Marn, MS Zoubir Ouhib, MS NRC Sta Resource: Daniel Dimarco Charge On Dec 6, 2022, Dr. Darlene Meer, the ACMUI Chair, created a subcommiee on the development of a generic process checklist to help reduce medical events.
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Background===
Due to the increased number of medical events in 2021, a suggeson was made for the ACMUI to develop generic process checklists for all user procedures. It was noted that it may be appropriate to have the professional licensing boards take the lead on developing, communicang, and standardizing the checklists.
Development Process:
On 6 January 2025 the subcommiee met and discussed what items should be on a generic process checklist ulized to help avoid medical events in the clinical use of radioacve materials /
radiaon. It is understood that this generic process checklist would be focused on radiopharmaceucal but could be easily adapted by users to focus on other modalies of the use of radiaon in medical care such as brachytherapy or external beam radiaon therapy.
Generic Process Checklist Elements (using radiopharmaceucals as an example)
- Establish paent identy (2 methods ulized) o Determine pregnancy status if applicable
- Verify elements of the prescripon o Is it the correct radiopharmaceucal?
o Is it the correct dose?
Do laboratory results support the dose?
Do imaging results support therapy, if being performed?
o Is it the correct route of administraon?
- Are all professionals working within their scope of pracce?
- Conduct paent / family support educaon prior to administraon (consultaon) and is understood
- Verify that the dose matches the wrien direcve if applicable o If wrien direcve, comply with requirements of 10 CFR 35.41
- Is the route of administraon patent?
- Measure or calculate the radiopharmaceucal acvity
- Administer the dosage
- Check for possible extravasaon of injecon
- Record keeping is conducted (residual acvity?)
- Paent release - dose to the public (Reg guide 8.39) - verbal, with interpreter if required and in wring, documentaon
- Contact informaon of Nuclear Medicine (or other applicable) department Local Customizaon is Required Each licensee / department shall develop a process (checklist) that is speci"c to their pracce and processes. This development should oen start by reviewing approved procedure documents and accreding organizaon requirements and any naonal paent safety goals that have been established. All process checklists / processes should work together to assure the Five Rights of Medicaon Administraon
- the right paent
- the right drug
- the right route
- the right dose
- at the right me
A Checklist does not mean it must be paper based While a paper checklist could be ulized, it is understood that modern means ulizing soware plaorms and barcodes could be extremely bene"cial in prevenng medicaon errors / medical events. These could include the following.
- CPOE - computerized prescripon order entry
- IVWMS-IV Work"ow Management Systems
- eMAR - electronic medicaon administraon records
- BCMA - barcode medicaon administraon E-prescribing has been shown to reduce medicaon errors in the ambulatory seng by as much as sevenfold.1 It was found that aer implementaon of BCMA, nonming errors had a relave risk reducon (RRR) of 41.4%, wrong medicaon errors had a RRR of 57.4%, wrong dose errors had a RRR of 41.9%, wrong route of administraon errors had a RRR of 68%, and administraon documentaon errors had a RRR of 80.3%.2
- 1.
Porter"eld, A., Engelbert, K., & Coustasse, A. (2014). Electronic prescribing: Improving the eciency and accuracy of prescribing in the ambulatory care seng. Perspecves in Health Informaon Management, 11(Spring), 1-13.
- 2.
Shah, K., et al (2016), Bar Code Medicaon Administraon Technology: A Systemac Review of Impact on Paent Safety When Used with Computerized Prescriber Order Entry and Automated Dispensing Devices. Canadian Journal of Hospital Pharmacy, 69 (No 5), 394-402.
Summary The subcommiee developed a generic process checklist that could be adapted by licensees to help avoid medical events in the clinical use of radioacve materials / radiaon. Each licensee /
department should develop a process (checklist) that is speci"c to their pracce and processes.
Checklists to help prevent medical events would be most eecve if they incorporated soware plaorms and barcoding.
Recommendaons The subcommiee recommends the following.
Each licensee / department should develop a process (checklist) that is speci"c to their pracce and processes.
NRC sta should consider the best means to communicate this process (checklist) recommendaon to licensees, either by informaon noce or guidance document.
Respecully submied on February 12, 2025, Subcommiee on Development of a Generic Process Checklist to Help Reduce Medical Events Advisory Commiee on the Medical Uses of Isotopes (ACMUI)
U.S. Nuclear Regulatory Commission (NRC)