Medical physics practice guideline 4.b: Development, implementation, use and maintenance of safety checklists

Conroy, Leigh; Faught, Jacqueline T; Bowers, Erika; Ecclestone, Gillian; Santos, Luis E. Fong de los; Hsu, Annie; Johnson, Jennifer L.; Kim, Grace Gwe-Ya; Schechter, Naomi R.; Schubert, Laura; Sterling, David A.

doi:10.1002/acm2.13895

Cited by 10 publications

(11 citation statements)

References 51 publications

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“…Guidelines for the development and implementation of checklists have been recently updated. 21 It is interesting to note that the top failure modes in our analysis for ocular treatments do not entirely mirror the general risk assessment in proton therapy. AAPM Task Group Report 275 tabulated some of the failure modes most relevant to proton therapy.…”

Section: Discussionmentioning

confidence: 91%

“…Where automation or forcing measures could not be taken due to human interactions with patients, multiple intermediate actions such as time‐out cross‐checks were found effective in preventing potential errors, particularly immediately prior to treatment delivery. Guidelines for the development and implementation of checklists have been recently updated 21 …”

Section: Discussionmentioning

confidence: 99%

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Modernization of safety environment for a dedicated beamline for proton ocular therapy

Jee,

Verburg,

Ruggieri

et al. 2023

Medical Physics

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BackgroundProton therapy is an effective treatment for ocular melanoma, and other tumors of the eye. The fixed horizontal beamline dedicated to ocular treatments at Massachusetts General Hospital was originally commissioned in 2002, with much of the equipment, safety features, and practices dating back to an earlier implementation at Harvard Cyclotron in the 1970s.PurposeTo describe the experience of reevaluation and enhancement of the safety environment for one of the longest continuously operating proton therapy programs.MethodsSeveral enhancements in quality control had been introduced throughout the years of operation, as described in this manuscript, to better align the practice with the evolving standards of proton therapy and the demands of a modern hospital. We spotlight the design and results of the failure mode and effect analysis (FMEA), and subsequent actions introduced to mitigate the modes associated with elevated risk. The findings of the FMEA informed the specifications for the new software application, which facilitated the improved management of the treatment workflow and the image‐guidance aspects of ocular treatments.ResultsEleven failure modes identified as having the highest risk are described. Six of these were mitigated with the clinical roll‐out of a new application for image‐guided radiation therapy (IGRT). Others were addressed through task automation, the broader introduction of checklists, and enhancements in pre‐treatment staff‐led time‐out.ConclusionsThroughout the task of modernizing the safety system of our dedicated ocular beamline, FMEA proved to be an effective instrument in soliciting inputs from the staff about safety and workflow concerns, helping to identify steps associated with elevated failure risks. Risks were reduced with the clinical introduction of a new IGRT application, which integrates quality management tools widely recognized for their role in risk mitigation: automation of the data transfer and workflow steps, and with the introduction of checklists and redundancy cross‐checks.

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Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Modernization of safety environment for a dedicated beamline for proton ocular therapy

Jee,

Verburg,

Ruggieri

et al. 2023

Medical Physics

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“…Since this risk analysis was performed, a shorter online checklist was created. This checklist includes only the most important reminders in a concise format and better adheres to the recommendation of Medical Physics Practice Guideline 4.a for the development of checklists 4 . It is embedded with “yes”/“no” or fill‐in‐the‐blank answer prompts (see Figure 1).…”

Section: Resultsmentioning

confidence: 99%

Risk analysis of the Unity 1.5 T MR‐Linac adapt‐to‐position workflow

Liang¹,

Scripes²,

Tyagi³

et al. 2022

J Applied Clin Med Phys

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Background and Purpose: Newer technologies allow for daily treatment adaptation, providing the ability to account for setup variations and organ motion but comes at the cost of increasing the treatment workflow complexity. One such technology is the adapt-to-position (ATP) workflow on the Unity MR-Linac. Prospective risk assessment of a new workflow allows clinics to catch errors before they occur, especially for processes that include novel and unfamiliar steps. Methods: As part of a quality management program, failure modes and effects analysis was performed on the ATP treatment workflow following the recommendations of AAPM's Task Group 100. A multidisciplinary team was formed to identify and evaluate failure modes for all the steps taken during a daily treatment workflow. Failure modes of high severity and overall score were isolated and addressed. Results: Mitigations were determined for high-ranking failure modes and implemented into the clinic. High-ranking failure modes existed in all steps of the workflow. Failure modes were then rescored to evaluate the effectiveness of the mitigations. Conclusion: Failure modes and effects analysis on the Unity MR-Linac highlighted areas in the ATP workflow that could be prone to failures and allowed our clinic to change the process to be more robust.

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“…The process for infusion should be developed and tested as part of commissioning, and may benefit from the use of checklists. 26 Steps to address extravasation can also be included on the checklist, and should follow guidelines in place at the treating center. Some commonly recommended steps including pausing the infusion, elevating the injection site, and applying warm compresses on the infusion site to accelerate vasodilation and blood flow to the tissues allowing dispersion of the drug from the area.…”

Section: Generate the Written Procedures And Accompanying Formsmentioning

confidence: 99%

“…With vial or syringe, there is a need to monitor for leaks and for extravasation during the infusion. The process for infusion should be developed and tested as part of commissioning, and may benefit from the use of checklists 26 . Steps to address extravasation can also be included on the checklist, and should follow guidelines in place at the treating center.…”

Section: Generate the Written Procedures And Accompanying Formsmentioning

confidence: 99%

Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program: A case in Lutetium‐177 prostate‐specific membrane antigen (PSMA) therapy

Zoberi

Garcia-Ramirez

Luechtefeld

et al. 2023

J Applied Clin Med Phys

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Prostate‐specific membrane antigen (PSMA) is a cell surface protein highly expressed in nearly all prostate cancers, with restricted expression in some normal tissues. The differential expression of PSMA from tumor to non‐tumor tissue has resulted in the investigation of numerous targeting strategies for therapy of patients with metastatic prostate cancer. In March of 2022, the FDA granted approval for the use of lutetium‐177 PSMA‐617 (Lu‐177‐PSMA‐617) for patients with PSMA‐positive metastatic castration‐resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane‐based chemotherapy. Therefore, the use of Lu‐177‐PSMA‐617 is expected to increase and become more widespread. Herein, we describe logistical, technical, and radiation safety considerations for implementing a radiopharmaceutical therapy program, with particular focus on the development of operating procedures for therapeutic administrations. Major steps for a center in the U.S. to implement a new radiopharmaceutical therapy (RPT) program are listed below, and then demonstrated in greater detail via examples for Lu‐177‐PSMA‐617 therapy.

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Medical physics practice guideline 4.b: Development, implementation, use and maintenance of safety checklists

Cited by 10 publications

References 51 publications

Modernization of safety environment for a dedicated beamline for proton ocular therapy

Modernization of safety environment for a dedicated beamline for proton ocular therapy

Risk analysis of the Unity 1.5 T MR‐Linac adapt‐to‐position workflow

Logistical, technical, and radiation safety aspects of establishing a radiopharmaceutical therapy program: A case in Lutetium‐177 prostate‐specific membrane antigen (PSMA) therapy

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