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Applying TG-100 Methodology to SRS / SBRT Jennifer Lynn Johnson, MS, MBA Senior Medical Physicist and Director for Safety, Radiation Physics [email protected] Patient Safety in the Treatment Process

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Applying TG-100 Methodology to SRS / SBRT

Jennifer Lynn Johnson, MS, MBASenior Medical Physicist and Director for Safety, Radiation [email protected]

Patient Safety in the Treatment Process

MD Anderson

AAPM Working Group on Prevention of Errors, Chair

Special thanks to:• Team members of the Division at Radiation Oncology• Julian R Perks, et. al.• Laura Masini, et. al.• Kelly Cooper Younge, et. al.• F Yang, et. al.• Ryan P. Manger, et. al.

Disclosures2Patient Safety in the Treatment Process

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Clearly, we want to avoid patient harm.

We typically measure and respond to specific incidents of harm.

Can we do better?

3Patient Safety in the Treatment Process

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Contents

1 RISK

2 SRS / SBRT QA PROGRAM

3 SRS / SBRT PROCESS

4 FAILURE MODES AND EFFECTS ANALYSIS

5 FAULT TREE ANALYSIS

6 SOPS FOR MAJOR STEPS

7 SAFETY CHECKLIST

8 PROGRAM MONITORING

Patient Safety in the Treatment Process 4

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Risk

5Patient Safety in the Treatment Process

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Risk is the likelihood a hazard causes harm to a patient.

What can go wrong?

How likely is it to go wrong?

What are the consequences if it goes wrong?

Defining Risk6Patient Safety in the Treatment Process

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RT is adopting incident learning system (ILS)

• Reactive: identify after the fact, control only for the future

• Difficult to monitor low occurrence incidents

High risk industries identify, control and monitor hazards

Allows active management of the environment

• Manage the hazards that give rise to risk

• Create resilience for unexpected risks

Risk Management7Patient Safety in the Treatment Process

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Prospectively analyze hazards in a process.

For the RT treatment process, AAPM TG-100 uses:

• Process Mapping

• Failure Modes and Effects Analysis

• Fault Tree Analysis

Structured ways to prioritize risk and determine where to focus resources

Risk Assessment8Patient Safety in the Treatment Process

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SRS / SBRT is typically a complete course of radiation therapy (RT) delivered in 1 to 5 sessions (fractions).

SRS / SBRT requires greater precision and accuracy than conventionally fractionated RT => follow strict protocols for quality assurance (QA).

9Patient Safety in the Treatment Process

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ACR–ASTRO Practice Parameter for the Performance of Stereotactic Body Radiation Therapy. Practice guidelines and technical standards. Reston, VA: American College of Radiology; 2014: 1-11.

ACR–ASTRO Practice Parameter for the Performance of Stereotactic Radiosurgery. Practice guidelines and technical standards. Reston, VA: American College of Radiology; 2014: 1-11.

Benedict SH, Yenice KM, Followill D, et al. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010;37(8):4078-4101.

Keall PJ, Mageras GS, Balter JM, et al. The management of respiratory motion in radiation oncology report of AAPM Task Group 76. Med Phys. 2006;33(10):3874-3900.

Klein EE, Hanley J, Bayouth J, et al. Task Group 142 report: quality assurance of medical accelerators. Med Phys. 2009;36(9):4197-4212.

Solberg TD, Balter JM, Benedict SH, Fraass BA, Kavanagh B, Miyamoto C, Pawlicki T, Potters L, Yamada Y. Quality and safety considerations in stereotactic radiosurgery and stereotactic body radiation therapy. Prac. Rad. Onc. 2012; Mar 31;2(1):2-9.

Published Guidance for Comprehensive QA10Patient Safety in the Treatment Process

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“Central goal of patient safety is to avoid potential harm rather than compliance with systems and processes.”

11Patient Safety in the Treatment Process

Vincent C, Burnett S, Carthey J. The measurement and monitoring of safety. London: The Health Foundation. 2013 May 24;2013.

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SRS / SBRT Process

12Patient Safety in the Treatment Process

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Visual illustration of the steps in a process

What is accomplished

How steps are related

Process steps may be subdivided into sub-processes, and so on.

Process Mapping13Patient Safety in the Treatment Process

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Imaging

Treatment Planning

Dose Delivery

Generic SRS / SBRT ProcedurePatient Safety in the Treatment Process 14

Adapted from Ford, E. C., et al. "Consensus recommendations for incident learning database structures in radiation oncology." Medical physics 39.12 (2012): 7272-7290.

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Delivering modern external beam radiation therapy is not so simple.

15Patient Safety in the Treatment Process

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MDACC Radiation Oncology Process - EBRT

Adapted from Ford, E. C., et al. "Consensus recommendations for incident learning database structures in radiation oncology." Medical physics 39.12 (2012): 7272-7290.

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Failure Modes and Effects Analysis

Fault Tree Analysis

17Patient Safety in the Treatment Process

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Vocabulary:

• Failure mode: how a part or process can fail

• Cause: a deficiency that results in a failure mode; source of variation

• Effect: impact on a person if the failure mode is not prevented or corrected

A multidisciplinary team (experts) generate actual and potential risks (without QC)

Especially useful for high-risk processes

Structured approach that links failure modes to an effect

Failure Modes and Effects Analysis (FMEA)18Patient Safety in the Treatment Process

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Steps:

• Identify ways a sub-process (or product) can fail, both known & potential

• Determine each failure mode’s causes & effects • Assign a number to most severe (S)

effect

• Determine likelihood each failure mode’s occurrence (O) & detection (D)

Failure Modes and Effects Analysis (FMEA)19Patient Safety in the Treatment Process

Huq MS, Fraass BA, Dunscombe PB, Gibbons JP, Ibbott GS, Mundt AJ, Mutic S, Palta JR, Rath F, Thomadsen BR, Williamson JF. The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management. Medical Physics. 2016 Jul 1;43(7):4209-62

• Calculate risk priority number (RPN) = O x S x D

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Rank the RPN values (highest to lowest)

Pick the 3 failure modes with the highest RPN values and highest S values

• RPN ≥ 100

• S ≥ 7

Propose process changes that would decrease the probability of occurrence, O

Propose QC that would decrease the probability of un-detectability, D

Failure Modes and Effects Analysis (FMEA)20Patient Safety in the Treatment Process

Huq MS, Fraass BA, Dunscombe PB, Gibbons JP, Ibbott GS, Mundt AJ, Mutic S, Palta JR, Rath F, Thomadsen BR, Williamson JF. The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management. Medical Physics. 2016 Jul 1;43(7):4209-62

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Completing FMEAMDACC Exercise (2013)

21Patient Safety in the Treatment Process

Asked a multidisciplinary team to complete a survey

• For each of the sub-process steps

• Did not ask specific causesEstimating Failure Mode ScoresIn columns 2-4 of Table 1, use Table A (provided separately) to fill in your best estimate the following scores:O = Occurrence. The likelihood the failure would occur. (1-10)D = Detectability. The likelihood the failure would go undetected. (1-10)S = Severity. The severity of the consequences of the failure. (1-10)Again, imagine the worst case scenario. Consider each failure independently

• Team reviewed results together and agreed in general the RPN rankings

• Purpose for ILS action scale

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Completing FMEATreatment Planning – O, D, S

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Completing FMEAMDACC Exercise (2013) Calculating RPN

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Completing FMEAMDACC Exercise (2013) Ranking RPN

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Completing FMEAMDACC Exercise (2013) RPN vs. S

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Divisional RPN Physics RPN

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Completing FMEAMDACC Exercise (2013) RPN ≥ 100

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Completing FMEAMDACC Exercise (2013) S ≥ 7

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Propose process changes to decrease likelihood of occurrence (O).

Propose quality control to decrease likelihood of un-detectability (D).

28Patient Safety in the Treatment Process

Huq MS, Fraass BA, Dunscombe PB, Gibbons JP, Ibbott GS, Mundt AJ, Mutic S, Palta JR, Rath F, Thomadsen BR, Williamson JF. The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management. Medical Physics. 2016 Jul 1;43(7):4209-62

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Evaluate the propagation of failures

• Gives visual representation of propagation of a failure in the process

• Helps identify intervention strategies to mitigate the FMEA identified risks

Fault Tree Analysis (FTA)29Patient Safety in the Treatment Process

Huq MS, Fraass BA, Dunscombe PB, Gibbons JP, Ibbott GS, Mundt AJ, Mutic S, Palta JR, Rath F, Thomadsen BR, Williamson JF. The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management. Medical Physics. 2016 Jul 1;43(7):4209-62

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Fault Tree Analysis (FTA)30Patient Safety in the Treatment Process

Steps

• Define the undesired event

• Understand the system

• Construct the fault tree

• Evaluate the fault tree

• Control the identified hazards

Huq MS, Fraass BA, Dunscombe PB, Gibbons JP, Ibbott GS, Mundt AJ, Mutic S, Palta JR, Rath F, Thomadsen BR, Williamson JF. The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management. Medical Physics. 2016 Jul 1;43(7):4209-62

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Fault Tree Analysis (FTA)31Patient Safety in the Treatment Process

Events in a fault tree are associated with statistical probabilities

• AND gate probability of output:• P(A and B) = P(A∩B) = P(A) P(B)

• OR gate probability of output:• P(A or B) = P(AUB) = P(A) + P(B) -

P(A∩B)

Huq MS, Fraass BA, Dunscombe PB, Gibbons JP, Ibbott GS, Mundt AJ, Mutic S, Palta JR, Rath F, Thomadsen BR, Williamson JF. The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management. Medical Physics. 2016 Jul 1;43(7):4209-62

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Utilization of Process Maps, FMEA, and FTA enable development of your Quality Management program.

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Comprehensive QA ProgramMDACC Exercise (2013) – Improvements in Progress

36Patient Safety in the Treatment Process

Immobilization and Simulation Devices

Treatment Planning System

Treatment Delivery Unit

Ancillary Systems for Imaging and Motion Management

Patient-specific Treatment Delivery Parameter Validation

Other – RO Treatment Planning

Other – Treatment Delivery

QMP, RO present

Committee review required prior release

QMP peer review QA

Improved engineering notifications

Improved SRS / SBRT treatment checklist

RTT time out process & checklist

Dosimetry checklist

RO Peer review

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Experience39Patient Safety in the Treatment Process

Perks, J. R., Stanic, S., Stern, R. L., Henk, B., Nelson, M. S., Harse, R. D., ... & Chen, A. M. (2012). Failure mode and effect analysis for delivery of lung stereotactic body radiation therapy. International Journal of Radiation Oncology* Biology* Physics, 83(4), 1324-1329.

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CBCT isocenter misalignment -> vigilent IGRT QA

Automatic setup failure -> frame agreement within 2 mm CBCT

Improper laser marking or transcription error for couch movements -> instituted dry run to test need to translate patient away from iso

Patient movements during treatment -> considering infrared surface tracking

Instituted checklists

Reviewed staffing levels

Experience40Patient Safety in the Treatment Process

Perks, J. R., Stanic, S., Stern, R. L., Henk, B., Nelson, M. S., Harse, R. D., ... & Chen, A. M. (2012). Failure mode and effect analysis for delivery of lung stereotactic body radiation therapy. International Journal of Radiation Oncology* Biology* Physics, 83(4), 1324-1329.

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Experience41Patient Safety in the Treatment Process

Masini, L., Donis, L., Loi, G., Mones, E., Molina, E., Bolchini, C., & Krengli, M. (2014). Application of failure mode and effects analysis to intracranial stereotactic radiation surgery by linear accelerator. Practical radiation oncology, 4(6), 392-397.

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Wrong collimator selection -> instituted bar code reader

Isocenter localization -> utilize infrared surface tracking for independent localization system verification

Target and OAR contours -> contour peer review

RO consults similar patients -> cross-check clinical documentation

Training, roles & responsibilities

Scheduling of treatments

Experience42Patient Safety in the Treatment Process

Masini, L., Donis, L., Loi, G., Mones, E., Molina, E., Bolchini, C., & Krengli, M. (2014). Application of failure mode and effects analysis to intracranial stereotactic radiation surgery by linear accelerator. Practical radiation oncology, 4(6), 392-397.

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Changes perceptions of risk

Experience43Patient Safety in the Treatment Process

Younge, K. C., Wang, Y., Thompson, J., Giovinazzo, J., Finlay, M., & Sankreacha, R. (2015). Practical implementation of failure mode and effects analysis for safety and efficiency in stereotactic radiosurgery. International Journal of Radiation Oncology* Biology* Physics, 91(5), 1003-1008.

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Mask fitting -> monitor pre-treatment and post-treatment imaging

Patient orientation on MRI -> additional staff checks

Contours -> additional auto comparison of approved versus final plan

Contours -> mandatory peer review prior to treatment planning

Experience44Patient Safety in the Treatment Process

Younge, K. C., Wang, Y., Thompson, J., Giovinazzo, J., Finlay, M., & Sankreacha, R. (2015). Practical implementation of failure mode and effects analysis for safety and efficiency in stereotactic radiosurgery. International Journal of Radiation Oncology* Biology* Physics, 91(5), 1003-1008.

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Criterion-based FMEA compared with incidents reported in ILS

-> 61% (20/33) identified by FMEA

->39% (13/33) not identified by FMEA ->Significantly lower RPNs

Experience45Patient Safety in the Treatment Process

Yang, F., Cao, N., Young, L., Howard, J., Logan, W., Arbuckle, T., ... & Ford, E. (2015). Validating FMEA output against incident learning data: A study in stereotactic body radiation therapy. Medical physics, 42(6), 2777-2785.

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16 / 91 steps surface imaging

25 / 167 had RPN >100-> 1 related to surface imaging

Use systematic approach to FMEA(e.g., HAZOP or SHERPA)

Experience46Patient Safety in the Treatment Process

Manger, R. P., Paxton, A. B., Pawlicki, T., & Kim, G. Y. (2015). Failure mode and effects analysis and fault tree analysis of surface image guided cranial radiosurgery. Medical physics, 42(5), 2449-2461.

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Experience47Patient Safety in the Treatment Process

Manger, R. P., Paxton, A. B., Pawlicki, T., & Kim, G. Y. (2015). Failure mode and effects analysis and fault tree analysis of surface image guided cranial radiosurgery. Medical physics, 42(5), 2449-2461.

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Experience suggests Standardized Operating Procedures (SOPs) for major steps are critical to patient safety.

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Safety ChecklistMedical Physics Practice Guideline 4.a

49Patient Safety in the Treatment Process

Role of checklists

Organizational influences on checklists: safety culture

Teamwork is essential

Development & Implementation

Revision

Maintenance

de los Santos LE, Evans S, Ford EC, Gaiser JE, Hayden SE, Huffman KE, Johnson JL, Mechalakos JG, Stern RL, Terezakis S, Thomadsen BR. Medical Physics Practice Guideline 4. a: Development, implementation, use and maintenance of safety checklists. Journal of Applied Clinical Medical Physics. 2015 May 8;16(3).

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Use of checklists

Design recommendations

• Content

• Workflow, layout & format

• Physical characteristics (e.g., font, text color, shading)

Safety ChecklistMedical Physics Practice Guideline 4.a

50Patient Safety in the Treatment Process

de los Santos LE, Evans S, Ford EC, Gaiser JE, Hayden SE, Huffman KE, Johnson JL, Mechalakos JG, Stern RL, Terezakis S, Thomadsen BR. Medical Physics Practice Guideline 4. a: Development, implementation, use and maintenance of safety checklists. Journal of Applied Clinical Medical Physics. 2015 May 8;16(3).

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Safety Checklist Samples51Patient Safety in the Treatment Process

Solberg TD, Balter JM, Benedict SH, Fraass BA, Kavanagh B, Miyamoto C, Pawlicki T, Potters L, Yamada Y. Quality and safety considerations in stereotactic radiosurgery and stereotactic body radiation therapy. Practical Radiation Oncology. 2012; Mar 31;2(1):2-9.

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Program Monitoring Patient Safety

Past harm

Reliability

Sensitivity to operations

Anticipation and preparedness

Integration and learning

Vincent, C., Burnett, S., & Carthey, J. (2013). The measurement and monitoring of safety. The Health Foundation

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Program Monitoring Patient Safety54Patient Safety in the Treatment Process

Past Harm

• SafetyLink ILS

• Outcomes

Reliability

• Improved standardized protocols and guidelines

Sensitivity to Operations

• Daily Coms

• Team operation huddles

Anticipation and Preparedness

• Checklists

• Safety culture

• Staffing indicators (absence rates)

Integration and Learning

• Walk-rounds

• Patient surveys

• Chart audits, dashboards

• ILS and RCAVincent, C., Burnett, S., & Carthey, J. (2013). The measurement and monitoring of safety. The Health Foundation