Safety and QualSafety and QualTher

Indrin J ChIndrin J. Ch

Henry Ford Hy

lity in Radiationlity in Radiation rapypy

hetty PhDhetty, PhD

Health Systemy

DiscloDisclo

My department receives r

• NIH/NCI

• Varian Medical Systems• Varian Medical Systems

• Philips HealthCare

osureosure

research support from:

ss

Learning ObjeLearning Obje

T d t d l itTo understand complexity

To review causes of errorsTo review causes of errorsfactors

To discuss the role of the fsafety

What should we be doing

ctives/Outlinectives/Outline

i di thy in radiotherapy

s emphasis on humans – emphasis on human

physician in the culture of

to improve safety in RT?

Pre Test Q

Research studies haveResearch studies have can be attributed to ___incidents in radiation thincidents in radiation th

A 0 20A. 0-20 B. 20-40 C 40 60C. 40-60 D. 60-80 E 80 100E. 80-100

Question

shown that human factorsshown that human factors __% of safety-related erapyerapy.

n 2010 a series of articlesn 2010 a series of articles safety in Radiation Oncolog

December 28, 2010: The New Yortitl d "A Pi i t B St Ititled "A Pinpoint Beam Strays InHealing." ASTRO submitted a Leta more comprehensive responsea more comprehensive response from Dr. Zietman (ASTRO Chair),

“All available evidence indicates described in this article are extredescribed in this article are extreflying a plane, even a single errospecialty is working to eliminatespecialty is working to eliminate

in the NY times challengedin the NY times challengedgy

rk Times published an article i ibl H i I t d fnvisibly, Harming Instead of

tter to the Editor and developed to the article in an ASTROgramto the article in an ASTROgram sent to the membership

that errors like the ones emely rare. However, as withemely rare. However, as with r is one too many and our them.” them.

Letter from Dr. Zietman (ASTRO

Interconn

In 2004, ASTRO established IHE-RO (In)Radiation Oncology) in recognition of

advanced technologies unless “there between software and hardware regbetween software and hardware, regmanufacturer.”…Significant resourcesthat medical technologies from differgtransfer information, though the “lackstill a problem.”

O Chair)…Safety Initiatives

nectivity

ntegrating the Healthcare Enterprise-f the risks associated with new and was perfect communication ardless of theardless of the

s have been committed to ensure ent manufacturers can seamlessly yk of connectivity among systems is

Letter from Dr. Zietman (ASTRO

Error Re

“In January 2010, ASTRO launched its comprehensive plan to help to ratchetASTRO has proposed federal legislatioerror reporting system and a patient s

l E d i tioncology. Error and near-miss reportinproblems and find patterns but will aldissemination of alerts when problemdissemination of alerts when problem

O Chair)…Safety Initiatives

eporting

Target Safely campaign, a t patient safety up even further.”

on to develop a national medical safety database for radiation

ill t l d t t ding will not only detect sporadic llow for the rapid and wide

ms occur ”ms occur….

Response letter from Dr. Zietma

A culture

“ Every individual on the radiation onthe culture of quality assurance and qhave fortified our educational programto maintain their physician certificatioto maintain their physician certificatioconsensus-based white papers on safon newer technologies such as stereogIMRT and SRS/SBRT are now on-line o

an (ASTRO Chair)…….

of safety

cology team has to be immersed in quality improvement. To this end, we m for radiation oncologists wishing on We are producing a series ofon... We are producing a series of fety and quality, with a specific focus otactic radiosurgery.” Reports on g y pout for public comment.

Response letter from Dr. Zietma

Patient A

“ What is a patient to do? How can thel f ili i i honcology facility is operating at the sa

patient supports groups, cancer survivo create a list of questions patients sho create a list of questions patients shenters when considering radiation th

questions available for download on oqo view as videos posted on YouTube.

an (ASTRO Chair)…….

Advocacy

ey know whether their radiation f l l? h k d i hfest level? ASTRO has worked with

vors and other medical organizations hould ask their physicians and cancerhould ask their physicians and cancererapy ….We have made these

our patient website rtanswers.org andp g

Other ASTRO/AAPM spon

une 2010, ASTRO and AAPM c“Safety in Radiation Therapy“Safety in Radiation Therapy –by Dr. Williams (ASTRO preside

id t) d D H d (AAPpresident) and Dr. Hendee (AAP

STRO (Dr. Zietman) leading a mhe Bluebook (May 2011) – recohe luebook (May 0 ) recond quality standards in RT, incl

sored safety initiatives

o-sponsored a symposium: A call to action” co chairedA call to action” – co-chaired

ent), Dr. Herman (AAPM PM)PM)

multi-society initiative to updatommendations on basic safety ommendations on basic safetyuding staffing levels

ASTRO/AAPM Safety Sy

• Complexity in RT

• What can go wrong in RTWhat can go wrong in RT

• Errors in RT – perspective o

• Errors in RT - perspective o

Th f ti f th RT t• The function of the RT team

• The culture of patient safe

• Education, Experience and

• What are we doing to addr

• Complex Systems and the• Complex Systems and the

• Accreditation, Regulation a

ymposium: June 2010

of the manufacturers

of the regulators

m

ety

d MOC – what is needed?

ress patient safety?

Human Interface Human Interface

and Event Reporting

RT: A Simple Goal: Optimiz

In a Highly CompleIn a Highly Comple

Differen• Physic

• Different types of cancer• Different Tx techniques

• Physic• Therap

iMulti- vs. single-vendor

• Dosim• IT/IS S• Admin• Clinical

environments

• Admin• Research

ze the Therapeutic Ratio

ex Environmentex Environment

nt users:cians

TechnologicalInnovations:

cistspists

i

• EPID• kV localize

CBCTmetristsStaffnistrative Staff

• CBCT• Other IGRT• Off line/on-linenistrative Staff • Off line/on-line

Adapted from M. Herma

IMRT: AAPM TG-(failure mode effec(failure mode effec

-100 (Huq et al.) cts analysis FMEA)cts analysis FMEA)

Courtesy: M. Herma

Complex TxDual energy phmode), 6 e’ ene

6D-robotic hcouch MV-EPID

http://www.novalistxradiosurgery

x Devices: hoton + 6X (SRS ergies + HD-MLC

Two entirely independent Tx planning s stems

KV -OBI

planning systems

6D Couch isKV OBI 6D Couch is controlled by one control system andthe standard couchby the other

d t lvendors control system

X-Ray

D INTERCONNECTIVIT

y.com/technology/delivery-system/

What causes erIncident Learning System

(Calgary) InfStandards/Procedures/Practices (~67%)

StaPra

Communication (~17%) PlaJudgment (~11%) CoMaterials/Tools/Equipment (~9%)

MaEq

Knowledge/Skill (~7%) KnPlanning (~4%) Jug ( )Design (~3%) DeCapabilities (~2%) CaCapabilities (~2%) Ca

rrors to occur?Radiation Oncology Safety

formation System (ROSIS, Europe)andards/Procedures/actices (~54%)anning (~16%)ommunication (~13%)aterials/Tools/quipment (~12%)nowledge/Skill (~12%)dgment (~6%)g ( )

esign (<1%)apabilities (0)

Courtesy: P. Dunscomb

apabilities (0)

Causes o

Research studies have shownResearch studies have showncan be attributed to human fcan be attributed to human fcan be attributed to human fcan be attributed to human fpolicies/procedurespolicies/procedures

What can we do tffactors

A lot! Human Factors EngineA lot! Human Factors EngineA lot! Human Factors EngineA lot! Human Factors Engine

Minimize human interaction Minimize human interaction

Improve behavior, attitude, eImprove behavior, attitude, ei f ti t i hi f ti t i hinformation to improve humainformation to improve huma

of Errors

n that n that 60 60 –– 80% of incidents 80% of incidents factorsfactors related primarily torelated primarily tofactorsfactors, related primarily to , related primarily to

to address human issues?

eeringeeringeering…eering…

in complex processesin complex processes

enhance education and enhance education and ffan performancean performance

From P. Dunscom

Human Factors Engin

Princess Margaret Hospital [Cg p [factors to identify and mitigattherapy: Radiotherapy Oncolotherapy: Radiotherapy Oncolo

Objective: to determine whetdesigning technology to improdesigning technology to improenvironment can have a posit

hi i t ti d dmachine interaction, and redu

neering: Example

Chan et al.: “The use of human te safety issues in radiation ogy, 97 2010]ogy, 97 2010]

ther evaluating and re-ove workflow and workove workflow and work tive influence on human-uce errors.

Human Factors Engine

Field observations - observe how ush d h f lover a 3-month period at the Tx facil

Workflow analysis – identify areas aWorkflow analysis – identify areas aincidents

Existing system was redesigned usin

16 RT students participated in usabiand redesigned interfaces. Three errimportant note (2) shifting the treatimportant note, (2) shifting the treatoverlooking a change of approval da

eering: Example

sers interact with the delivery systemllities

associated with a high likelihood ofassociated with a high likelihood of

ng a user-centered approach

ility testing to compare the current rors were evaluated: (1) overlooking antment couch incorrectly and (3)tment couch incorrectly, and (3) tes.

Human Factors EngineeWorkflow analysis - particular conceby therapists prior to TX delivery. Due(workflow) and the environment clut(workflow) and the environment clutprocess) pre-Tx checking process fouNew system redesigned to include efNew system redesigned to include efworkflow environment improved: red

73%

433%

4

ering: Example: Resultsrn was the checking process performee to the multiple Tx checks required tter (multiple screens in the R/V TXtter (multiple screens in the R/V, TX nd to be inefficient and inconvenient.

fficient structure with fewer steps; fficient structure with fewer steps; duce clutter, highlight important info…

44%56%

44%

Chan et al.: Radioth OncRadioth. Onc97, 2010

How do we develop and fp

We must first Admit tWe must first Admit t

“Hardware breaks, softbugs, processes mutabugs, processes mutapeople make mistake

Clinics everywhere are k d f (kinds of errors (i.e., in

foster a culture of safety?y

there is a Problem!there is a Problem!

tware always has ate and devolve, andate and devolve, and es !”

susceptible to many l d b ) !ncluding big ones) !

Adapted from B Fraas

A Culture of Safety: Th

Patient safety and quality musth h i i d th ithe physicians and other senio

The Physician’s roThe Physician’s ro

•• Societal RespSocietal Resp

•• Clinical PerspClinical PerspClinical PerspClinical Persp

•• Role as a leadRole as a lead

Physician is in a unique role toPhysician is in a unique role to

e role of the Physician

st be driven from the TOP, i.e. i tit ti l l dor institutional leaders

ole is Uniqueole is Unique

ponsibilityponsibility

pectivepectivepectivepective

derder

champion for a culture change champion for a culture change

Adapted from L Mark

Approaches for champio–– Acknowledge the risksAcknowledge the risks

–– Speak openly: staff, adSpeak openly: staff, adSpeak openly: staff, adSpeak openly: staff, ad

–– Foster a nonFoster a non--punitive epunitive e

–– Empower and support Empower and support

–– Celebrate other’s accomCelebrate other’s accom

Enhance EducationEnhance Education: M&M con: M&M conti d t t l f tti d t t l f tmeetings, departmental safetmeetings, departmental safet

Incorporate safety into all dIncorporate safety into all d

Change is hard Change is hard SucceSucce

Incorporate safety into all dIncorporate safety into all d

oning a culture of safety

ministrators, patientsministrators, patientsministrators, patientsministrators, patients

environmentenvironment

othersothers

mplishments in QA arenamplishments in QA arenapp

nferences, nferences, Safety Rounds, Safety Rounds, QA QA t t t tt t t tty engagement retreatsty engagement retreats

departmental activitiesdepartmental activities

ess = ess = ff (leadership)(leadership)

departmental activitiesdepartmental activities

Adapted from L Mar

Physician’s Role: Trendsettting examples from UNC

Courtesy: L Marks

Physician’s Role: Trendset

Suggestion boxes for feedback on improving processes

tting examples from UNC

Courtesy: L Marks

Daily morning conferenplanning

Respectful questioRespectful questioplanning

a teaa tea

ce to review cases in TX g queueoning, building oning, building g queue

amam

C tCourtesL Marks

HFHS Radiation Oncology V

Available on the HFHS Radonc I

Variance Reporting Database

Intranet at all TX workstations

HF Hospital Radiation Oncologyy Variance Reporting Database

How should we initiate/ree

Refer to national guidelines/consreports, white papers for the basf ifi i l t ti

ASTRO QA/Safety Sub-comm

for specific implementation

ASTRO QA/Safety Sub comm

IMRT J Moran SRS/SBRT

HDRT Solberg

B ThomadsHDRIGRT

B ThomadsD Jaffray

Peer Review . . .

L Marks

Effort supervised by Fra

evaluate safety programs?

sensus documents, committee sic needs – tailor the program

mittee: Safety White Papersmittee: Safety White Papers

PhD Published PROg PhDsen PhD

Published PROto expert reviewsen PhD

y PhDto expert reviewto public review

fs MD final edits

aass, Pawlicki, MarksAdapted:B Fraass

Recommendations to guard againFrom: “Safety considerations forFrom: Safety considerations for

nst catastrophic failures for IMRTr IMRT”, Moran et al. PRO 1:2011r IMRT , Moran et al. PRO : 0

Recommendations to guard againFrom: ASTRO IMRT white paper Mo

nst catastrophic failures for IMRToran et al. Moran et al. PRO 1:2011

The Value of

Two Remark

1. “The Check-List Manifei h ” (A l G dright” (Atul Gawande,

School))

2. “Safe Patients, Smart HD t h k li tDoctors check-list can healthcare from the inPronovost, MD, PhD anHopkins University)Hopkins University)

f Check-Lists

kable Books:

esto – How to get things MD H d M di lMD, Harvard Medical

Hospitals – How one h l hhelp us change

nside out” (Peter nd Eric Vohr, John’s

The Value of

Check-lists should be developeto ensure a given process to ensure a given processand consistently

Must be precise, to the point fcomprehensive to encompass

M i l d “bi i ” hMust include “big-picture” cheManifesto”) Example check-list

“FLY THE AI

A l l i RT “LOOK AT TAnalogously in RT: “LOOK AT T

f Check-Lists

ed from detailed procedures is implemented accurately is implemented accurately

for efficient implementation ball aspects of the procedure

k (f “ h kliecks: (from “Checklist on a single engine Cessna RPLANE”

THE MLC d i B ”THE MLCs during Beam on”

Check-lists in the electronic environment

Summ

atient safety and quality is the renvolved in treating patients withnvolved in treating patients with

A culture of safety should be devepen communication, reporting onvironment), with the goal of pr

Detailed procedures must be devconsensus based documents andconsensus-based documents andfoundation: empower your phys

mary

esponsibility of every individual RTRT

eloped and fostered to ensure of errors (in a non-punitive rocess improvement

veloped and followed, using d national standards as ad national standards as a icists to initiate this

Summ

Develop check-lists to ensure prp pimplemented accurately, consist

Improvement is an on-going procevaluation of procedures, and tra

mary

rocedures are being gtently and efficiently

cess and involves education, ansparent error-reporting

Acknowle

Larry MarksPeter Dunscombe, PhD (Univ. of C

Michael Herman, Dick Fraass, PhD (Un

ASTRO and AAPM leadership inASTRO and AAPM leadership inproviding guidance

Dr. Akila Viswanathan (Chair) anCristin Watson and oCristin Watson and o

ThankThank

dgements

s, MD (UNC)Calgary, Alberta Health SciencesPhD (Mayo Clinic)iversity of Michigan)

n taking proactive steps towardn taking proactive steps toward e on safe practices

nd Dr. Ramesh Rengan (Co-chair)other ASTRO HQ staffother ASTRO HQ staff

k You!k You!

Post Test

Research studies haveResearch studies have can be attributed to ___incidents in radiation thincidents in radiation th

A 0 20A. 0-20 B. 20-40 C 40 60C. 40-60 D. 60-80 E 80 100E. 80-100

Question

shown that human factorsshown that human factors __% of safety-related erapyerapy.

Test Questi

D: Safety incidents are errors; research shows can be attributed to huma Reference: P. Duscombe: “What catreatment?”, proceedingSymposium on Safety y p yMiami, June 2010.

ion Answer

heavily related to humanthat 60-80% of incidentsan factors.

an go wrong in radiationg ggs of the ASTRO/AAPM

in Radiation Therapy,py,