T. Yvette Forrest Division of Emergency Preparedness

and Community Support Bureau of Radiation Control Florida Department of Health

Medical Errors in Radiation Therapy 2014-2015

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Reportable Medical Events

State of Florida Radiation Therapy Use of Radioactive Materials The Joint Commission Fluoroscopy- Sentinel Event Prolonged fluoroscopy with cumulative dose >1500

rads to a single field or any delivery of radiotherapy to the wrong region or >25% above the planned dose

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Medical Events

Facilities delivering radiation therapy are required to report medical events: • Dose delivered by wrong mode of treatment,

wrong treatment, or wrong treatment site; or • Dose of radiation that differs greater than a

total of 30% of the prescribed dose in a week or 20% of the total prescribed dose.

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Where to Report

Facilities are required to report medical events within 24 hours of determination to: Radiation Machine Program 705 Wells Rd., Suite 300 Orange Park, FL 32073 904-278-5730

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Reported Medical Events 2014 -2015

11 medical events were investigated: 7 - delivered to the wrong body part/field 1 - delivered by wrong treatment 3 - delivered to the wrong patient

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Event 1 Whole Brain / Wrong Treatment

• Prescribed treatment = 3750 cGy in 15 fractions of 250 cGy daily using IMRT;

• Delivered dose = 10 fractions of 375 cGy; • Error discovered after 7th fraction; and • Treatment reviewed and approved by dosimetrist,

oncologist, physicist and therapists before delivery. Corrective Action: New policy regarding verification of physician prescription.

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Event 2 - Reportable Event Trigeminal Nerve / Wrong

Treatment Site

• Original referral = Left side 60 Gy gamma radiation using Cyberknife;

• Prescribed/Delivered treatment = Right side 60Gy Cyberknife; and

• The oncologist and neurosurgeon developed and approved the treatment plan in error.

Corrective Action: Laterality signed/verified by radiation oncologist and attending physician on all new trigeminal neuralgia patients.

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Event 3 Left Posterior Arm / Wrong

Treatment Site

• Prescribed treatment = 19.8 Gy in 11 fractions of 1.8 Gy each using EBR;

• Prescription did not clearly identify the anatomic location of the treatment site;

• Treatment site outline washed off; • Therapist used old treatment setup photo; and • Third fraction delivered to previously treated site. Corrective Action: Anatomic site names repeated in prescriptions only for re-treatment. 8

Event 4 Right Breast / Wrong

Treatment Site

• Prescribed treatment = Total 6640 cGy: – 5040 cGy in EBR with 1600 cGy boost HDR in 8

fractions of Iridium 192; • Spot function button disengaged, displaying

inaccurate values; • Therapists, physicist, and oncologist attribute

increased separation measurements to variation in patient thickness and positioning; and

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• Physicist did not verify plate separations before

continuing treatment. Corrective Action: Setup photos in two planes (CC & ML) taken with ruler to document plate separations then compared to display on unit.

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Event 5 Posterior Fifth Rib / Wrong

Treatment Site

• Prescribed treatment = Total 3750 cGy in 15 fractions of 250 cGy daily using IGRT;

• Delivered dose = One fraction 250 cGy to one half the target volume and 4 cm. inferior to the intended site;

• 4 therapists on 5 days used incorrect tattoos as reference point for treatment target;

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• Oncologist approved IGRT imaging, which did not indicate tattoo positioning;

• Therapists failed to document or communicate to other therapists the large couch shifts used to adjust after IGRT imaging;

• Ribs appeared aligned in IGRT images due to magnification, hiding adjacent peripheral anatomy;

• On treatments 7-10 different therapists setup to a tattoo from a previous treatment, after IGRT imaging, requiring a couch positioning shift 4 cm superiorly and 2 cm laterally to adjust; and

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Event 5

• On treatment 11 original therapist returns, also uses incorrect tattoo, IGRT images, and applies only a 2 cm lateral shift.

Corrective Action: Therapist applying shifts greater than 1 cm require approval from physician, physicist or dosimetrist (ASTRO guidelines). A triple-point tattoo is applied when new tattoo is within 15 cm of prior tattoo. The IGRT matching verified by second therapist, physician, physicist or dosimetrist. Setup notes are updated when parameters change.

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Event 6 Left Lower Leg / Wrong

Treatment Site

• Prescribed Treatment = 5500 cGy of EBR in 22 fractions of 250 cGy;

• Delivered = 1 fraction of 250 cGy to area 3 cm anterior to intended site on left leg;

• Patient had multiple lesions on same body part; • Setup photos were taken at a distance and angle

inadequately demonstrating landmark structures adjacent to treatment site; and

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• The Vacloc immobilization device, transparent template, and set up sheet, all lacked adequate labeling to prevent incorrect positioning of patient.

Corrective Action: Detailed labeling information on transparent template and set up sheet will identify at least 3 structures. Vacloc indexed and labeled for fixed location on table for simulation. Multiple setup photos at multiple angles and distances will document patient position.

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Event 7 Mid Lobe Lung T1bNO / Wrong

Treatment Site

• Prescribed Treatment = 5926.3 cGy of SBRT in 5 fractions of 11.85.26 cGy;

• Delivered = 1 fraction of 97.66 cGy to area 7 cm medial to intended site of left lung;

• Positioning couch lateral shift was made to allow for the gantry rotation between arcs to the next position;

• The table was not returned to the correct position following the lateral shift; and

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• Therapist or oncologist did not verify couch positioning parameters before proceeding with treatment.

Corrective Action: A timeout is required prior to treatment of the first field, after imaging shifts are made. Separate check sheet will document vertical, longitudinal, and lateral table values. Fraction shifts greater than 3 mm require further examination. Setup adjustments will now require 2 therapists in the room. Four infrared localization spheres are required.

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Event 8 Prostate / Wrong Treatment /

Wrong Patient

• Prescribed Treatment = 79.20 Gy of IMRT in 44

fractions of 1.80 Gy; • Delivered = 1 fraction of 1.32 cGy to area within 10

mm of prescribed site of prostate; • Administrative personnel identified the patient as

“completed” in error; • Therapists did not verify patient identification prior to

treatment; 18

• Therapist did not verify accuracy of the treatment field by use of fiducials, or patient anatomy prior to treatment; and

• Therapist selected, and administered treatment intended for another patient.

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Corrective Action: Positive patient identification is obtained before patients enter treatment room. A timeout is required prior to treatment to verify treatment plan and corresponding patient. Name alerts are used for patients with similar names. A monitor will be installed in treatment room with patient photo and treatment plan. Setup notes will include number of fiducials. Staff has been instructed in “manual completion reversal.” A product software change has been initiated, separating the “complete” and “check in” icons.

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Event 9 Spine T11-L5 / Wrong

Treatment / Wrong Patient

• Prescribed Treatment = 3200 cGy of EBRT in 8 daily fractions of 400 cGy;

• Delivered = 1 daily fraction of 400 cGy EBRT to an area outside of the prescribed spinal site, including liver and kidneys;

• Patient scheduled for treatment became ill, next patient on schedule was brought into treatment room without identification validation at treatment console;

• Patient was positioned using tattoos;

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• Therapist did not verify accuracy of the treatment field prior to treatment; and

• Therapist did not verify accuracy of the treatment plan, and administered treatment intended for the first patient.

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Corrective Action: Positive patient identification is obtained upon arrival at facility, and before patients enter treatment room, via identification armband, and photo badge. At treatment console patient I.D. is confirmed with badge, treatment chart photo and face sheet. Prior to patient treatment setup on table, a timeout is performed using “Patient and Procedure Confirmation” check sheet.

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Event 10 Urinary Bladder / Wrong

Treatment / Wrong Patient

• Prescribed Treatment = 63 Gy of IMRT in 25 and 10 daily fractions of 1.8 Gy to small pelvis;

• Delivered = 1 fraction of .9 Gy to small pelvis; • Therapist set up room and treatment plan for first

patient on schedule; • Patient that entered treatment room was the

second patient on schedule; • Positive patient identification was not obtained by

therapist prior to patient entering treatment room;

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• Therapist used vac-loc immobilization device label to confirm patient identification prior to positioning and setup of patient;

• Patient incorrectly identified themself using vac-loc immobilization device label; and

• Therapist did not verify accuracy of the treatment plan, and administered treatment intended for the first patient. 25

Corrective Action: Current policy and procedure for patient identification and timeout will be reinforced with retraining of the therapy staff.

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Event 11 Left Lower Leg / Wrong

Treatment Site

• Prescribed Treatment = 6000 cGy of EBRT in 20 fractions of 300 cGy;

• Delivered = 1 fraction of 300cGy to an area with negative biopsy results, not intended for treatment;

• The patient had multiple lesions in the area of treatment;

• The simulation setup photos were taken at a distance and angle that inadequately demonstrated landmark structures surrounding the treatment site;

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• A transparent template or “skin map” was not created at the time of simulation;

• Treatment field outlines were not visible at the time of the patient’s first treatment;

• The therapist delivered treatment to the patient without verification of the treatment site; and

• The facility lacked policy and procedure for treatment simulation and verification of treatment site.

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Corrective Action: Policy and procedure for treatment simulation has been implemented, requiring simulation photos that will include larger anatomical reference points. A clear plastic “skin map” of the treatment field and any other reference points, scars, tattoos, etc., and containing anatomical orientation labels, will be created. Upon the patient’s first treatment, the skin map will confirm the treatment area. Prior to the first treatment, the radiation oncologist will be called into the treatment room to verify the field.

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Event Commonalities

• Failure to follow or recognize deficiencies in policy and procedure;

• Inadequate transfer of information to all staff members;

• Staff relied on minimal methods of verification for treatment setup; and

• Staff counterintuitively resisted the need to verify patient identification, treatment plans, or review with radiation oncologist.

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Summary

• Medical events occur following a breakdown of 2 or more control elements. Every facility is vulnerable to these events.

• Facilities who have clear, well-developed procedures and who train to those procedures minimize the risk.

• Event reporting is mandatory, and should ultimately aid a facility in the revision or development of good policy and procedures, following an investigation.

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Contact Information

Amy Carlson, Environmental Specialist Medical Event Coordinator

X-Ray Machine Section Bureau of Radiation Control

705 Wells Road Orange Park, FL 32073

904-278-5730 Amy.Carlson@FLHealth.gov

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T. Yvette Forrest Division of Emergency Preparedness

and Community Support Bureau of Radiation Control Florida Department of Health

Medical Events What are you required to do?

1

Medical Events

Facilities delivering radiation therapy are required to report medical events: • Dose delivered by wrong mode of treatment,

wrong treatment, or wrong treatment site; or • Dose of radiation that differs greater than a

total of 30% of the prescribed dose in a week or 20% of the total prescribed dose.

2

Where to Report

Facilities are required to report medical events within 24 hours of determination by telephone: Radiation Machine Program 4052 Bald Cypress Way Tallahassee, Florida 850-245-4888

3

Phone Report

During the phone report you will be asked to provide a brief summary of the event. Additionally, written statements from all therapists who are involved will be requested. A site visit will be scheduled for the formal medical event investigation.

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What Happens Next?

The registrant shall also notify the referring physician and the affected individual. These notifications shall be made within 24 hours after discovery of medical event.

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Written Report

Within 15 days of the Medical Event the registrant shall provide the BRC with a written report. The report shall include: • Registrants name • Prescribing Physicians name • Referring Physicians name • Brief description of the event • Action taken to prevent reoccurrence.

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Written Report Continued

• Whether registrant informed individual and if not

provide written medical justification • The report shall not include information that could

lead to identification of the individual

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Site Visit

The site visit will cover the following areas: • Entrance interview and overview of investigation

process • Results of facilities investigation and corrective

actions • Interviews with physicists, chief therapist, and

dosimetrist or therapist involved • Interview with Oncologist if necessary or requested

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Site Visit Continued

• Review of 15-day reporting and patient notification

requirements • Documentation of existing or recommended

procedures and training • Exit interview with management • Overview of administrative fine process

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Day of Site Visit

• Staff may conduct their usual duties but should be

available to the inspector during the interview and records review portion to answer any questions regarding your facility’s procedures.

• PLEASE OBTAIN WRITTEN STATEMENTS FROM ALL INVOLVED PERSONNEL.

• Average on site inspection time is 4 hours.

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Event Commonalities

• Failure to follow or recognize deficiencies in policy and procedure;

• Inadequate transfer of information to all staff members;

• Staff reliance on minimal methods of verification for treatment setup; and

• Staff counterintuitively resisted the need to verify patient identification, treatment plans, or review with radiation oncologist.

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Summary

• Medical events occur following a breakdown of 2 or more control elements. Every facility is vulnerable to these events.

• Facilities who have clear, well-developed procedures and who train to those procedures minimize the risk.

• Event reporting is mandatory, and should ultimately aid a facility in the revision or development of good policy and procedures, following an investigation.

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Reported Medical Events 2014 -2015

11 medical events were investigated: 7 - delivered to the wrong body part/field 1 - delivered by wrong treatment 3 - delivered to the wrong patient

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Contact Information

Yvette Forrest, Environmental Specialist Medical Event Coordinator

X-Ray Machine Section Bureau of Radiation Control

4052 Bald Cypress Way, BIN 21 Tallahassee, Florida 32399

850-210-5036 Yvette.Forrest@FLHealth.gov

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