Getting to the Root Causes ofGetting to the Root Causes of Non-Compliance:Non-Compliance:

A Prescription for PreventionA Prescription for Prevention

Robert Emery, Dr.P.H., CHP, CIH, CSP, RBPRobert Emery, Dr.P.H., CHP, CIH, CSP, RBP University of Texas-Houston Health Science CenterUniversity of Texas-Houston Health Science Center

Michael Charlton, MS, MPH, CHP, CHMMMichael Charlton, MS, MPH, CHP, CHMM University of Texas Health Science Center-San AntonioUniversity of Texas Health Science Center-San Antonio

AmyAmy Orders, MS, RTOrders, MS, RT University of Texas-Houston Health Science CenterUniversity of Texas-Houston Health Science Center

Mike Hernandez, Graduate Biometry StudentMike Hernandez, Graduate Biometry Student University of Texas-Houston School of Public HealthUniversity of Texas-Houston School of Public Health

ObjectivesObjectives

�� To emphasize how stakeholdersTo emphasize how stakeholders reallyreally evaluate radiation safety programs and theevaluate radiation safety programs and the important role compliance plays in thisimportant role compliance plays in this assessmentassessment

�� ToTo objectivelyobjectively identify the commonidentify the common violations issued to permit holders in Texasviolations issued to permit holders in Texas

�� Show how this data can be put to use forShow how this data can be put to use for preventionprevention by identifying the root causes ofby identifying the root causes of non-compliancenon-compliance

�� Make you an offer youMake you an offer you can’tcan’t refuse!refuse!

Health and Safety OutcomeHealth and Safety Outcome MeasuresMeasures

�� SystemicSystemic: ultimate program outcomes: ultimate program outcomes �� number of injuries, illnesses, fatalitiesnumber of injuries, illnesses, fatalities �� OSHA 200 log or equivalentOSHA 200 log or equivalent

�� OrganicOrganic: indicators of program design and: indicators of program design and implementationimplementation �� numbers of unsafe conditions, practices,numbers of unsafe conditions, practices,

behaviors, attitudesbehaviors, attitudes �� regulatory complianceregulatory compliance

A Word About InspectionsA Word About Inspections (to the regulated community)(to the regulated community)

�� The public and the radiation safetyThe public and the radiation safety profession benefit from the complianceprofession benefit from the compliance inspection process.inspection process.

�� These works are intended to make permitThese works are intended to make permit holders aware of the common deficiencies,holders aware of the common deficiencies, so they can be avoided.so they can be avoided.

�� This should not be done to the exclusion ofThis should not be done to the exclusion of other important safety tasks!other important safety tasks!

��

��

��

Licensees:Licensees: Top Ten ViolationsTop Ten Violations 1988-19971988-1997

��

��

ProceduresProcedures 11%11% �� InventoriesInventories 6%6% Absent surveysAbsent surveys 10%10% �� Transfer recordsTransfer records 6%6% Leak testingLeak testing 8%8% �� Disposal recordsDisposal records 4%4% Personnel monitoringPersonnel monitoring 7%7% �� Main programMain program 4%4% Instrument calibration 7%Instrument calibration 7% �� TrainingTraining 2%2%

TotalTotal†† 65%65%

††Annual Top Ten Varied from 55% to 75% of all NOVsAnnual Top Ten Varied from 55% to 75% of all NOVs

Licensee:Licensee: Top Ten Violations By YearTop Ten Violations By Year 1988-19971988-1997

Pro

cedu

res

Sur

veys

Not

Don

e

Leak

Tes

ts N

ot D

one

Mon

itorin

g R

ecor

ds

Cal

ibra

tion

Exc

eede

d

Inve

ntor

y/U

se L

og

Tra

nsfe

r Rec

ords

Sur

veys

/Dis

posa

l Rec

ords

Insp

./Mai

n. N

ot D

one

Tra

inin

g

25.0%

20.0%

Percent of All Violations Issued

15.0%

10.0% 1988

5.0% 1991

0.0% 1994 Year

1997

��

��

Licensee NOV’s by RegulatoryLicensee NOV’s by Regulatory Citation: 25 TAC 289Citation: 25 TAC 289

202(e)202(e) Radiation protection programRadiation protection program 17%17%

201(g)201(g) Sealed source leak testSealed source leak test 16%16%

�� 202(p)202(p) Surveys and monitoringSurveys and monitoring 11%11% �� 201(o)201(o) General public dose limitsGeneral public dose limits 8%8% �� 201(d)201(d) Receipt, transfer,disposal recordsReceipt, transfer,disposal records 8%8%

�� Top five account for 60% of total, based onTop five account for 60% of total, based on 1999 data.1999 data.

Licensee ViolationsLicensee Violations Severity Level DistributionSeverity Level Distribution

1988-19971988-1997

Severity Level I Severity Level II 1%

Severity Level V 2% 4%

Severity Level III

Severity Level

21%

IV 72%

Educational ValueEducational Value

Figure 2: Summary of overexposure and total incidents reported to the Texas Department of Health, Bureau of Radiation Control from 1988 to 1997.

73

100

78

101 83 78

39

16 10 15

201

264

206

279

256 267

190

168

131

164

0

50

100

150

200

250

300

1986 1988 1990 1992 1994 1996 1998

Year

Num

ber

of E

vent

s

Overexposure Total Incidents

1994 - Revision of regulations (10CFR20).

Educational ValueEducational Value

Educational ValueEducational Value

Educational ValueEducational Value

What Does All This Cost?What Does All This Cost?

�� Estimating the administrative cost to theEstimating the administrative cost to the BRC associated with the issuance ofBRC associated with the issuance of violations:violations: �� baseline cost of inspection processbaseline cost of inspection process �� some added cost to issue and resolve NOV’ssome added cost to issue and resolve NOV’s �� if this added cost could be estimated, thenif this added cost could be estimated, then

reductions through education could bereductions through education could be quantifiedquantified

�� Cost to the permit holders not included, butCost to the permit holders not included, but equally importantequally important

Estimating the CostEstimating the Cost

$100,000.00

$90,000.00

$80,000.00

$70,000.00

$60,000.00

$50,000.00

$40,000.00

$30,000.00

$20,000.00

$10,000.00

$0.00

Licensees

R2 = 0.8014

Registrants

0 2000 4000 6000 8000 10000 12000 14000 16000

Number of Violations

Der

ived

Adm

inis

trat

ive

Cos

ts

The EU (Emery Unit)!The EU (Emery Unit)! Administrative dollars per NOV saved, at STPAdministrative dollars per NOV saved, at STP

��

The Next Step: Root Cause AnalysisThe Next Step: Root Cause Analysis Ex: Sealed Source Leak Test NOVEx: Sealed Source Leak Test NOV

ProblemProblem �� Root CauseRoot Cause �� Done or not doneDone or not done �� Failure to executeFailure to execute �� Ever? Or not atEver? Or not at

proscribed frequency?proscribed frequency? �� FrequencyFrequency �� Time frame based onTime frame based on �� Violation of regulationViolation of regulation

permit condition orpermit condition or or permit conditionor permit conditionregulation?regulation?

�� DocumentationDocumentation �� CompletenessCompleteness

incomplete?incomplete? �� Found leaking, but notFound leaking, but not

�� Inappropriate actionsInappropriate actionsreported?reported?

Fault Tree Analysis:Fault Tree Analysis: Sealed Source Leak Test NOVSealed Source Leak Test NOV

SEALED SOURCE LEAK TEST NOTICE OF

VIOLATION

VIOLATION OF PERMIT CONDITION

FAILURE TO EXECUTE DOCUMENTATION ACTIONSFREQUENCY

TASK NOT PERFORMED

PERFORMED BUT NOT

DOCUMENTED

PERFORMED BUT NOT FULLY DOCUMENTED/ INCORRECTLY DOCUMENTED

PERFORMED BUT NOT AT REQUIRED

FREQUENCY

FOUND LEAKING:NOT POSTED OR

TAKEN OUT OF SERVICE

FOUND LEAKING:

AUTHORITIES NOT NOTIFIED

VIOLATION OF REGULATION

FAILURE TO EXECUTE DOCUMENTATION ACTIONSFREQUENCY

TASK NOT PERFORMED

PERFORMED BUT NOT

DOCUMENTED

PERFORMED BUT NOT FULLY DOCUMENTED/ INCORRECTLY DOCUMENTED

PERFORMED BUT NOT AT REQUIRED

FREQUENCY

FOUND LEAKING:NOT POSTED OR

TAKEN OUT OF SERVICE

FOUND LEAKING:

AUTHORITIES NOT NOTIFIED

OROR

OR OR

OR OR

OR

Fault Tree Analysis:Fault Tree Analysis: Sealed Source Leak Test NOVSealed Source Leak Test NOV

VIOLATION OF REGULATION

FAILURE TO EXECUTE FREQUENCY ACTIONSDOCUMENTATION

OR

TASK NOT PERFORMED

PERFORMED BUT NOT

DOCUMENTED

BUT NOT FULLY BUT NOT AT

PERFORMED

DOCUMENTED/ INCORRECTLY DOCUMENTED

PERFORMED

REQUIRED FREQUENCY

OR

FOUND LEAKING:NOT POSTED OR

TAKEN OUT OF SERVICE

FOUND LEAKING:

AUTHORITIES NOT NOTIFIED

OR

Results of AnalysisResults of Analysis

INAPPROPRIATE OTHER ONLY ACTIONS ONLY

2% 5%

FAILURE TO EXECUTE

FAILURE TO EXECUTE FAILURE TO AND INAPPROPRIATE

EXECUTE AND ACTIONS OTHER 7%

FAILURE TO EXECUTE AND

COMPLETENESS 7%

34%

FAILURE TOFAILURE TO EXECUTE AND FREQUENCY EXECUTE

43% TOTAL 93%TOTAL 93%

ImplicationsImplications

�� Consider the findings within the context ofConsider the findings within the context of the regulator’s common plea: read yourthe regulator’s common plea: read your permit!permit! �� Do the permit holders really know what theyDo the permit holders really know what they

are supposed to do?are supposed to do?

�� What can be done to improve compliance?What can be done to improve compliance? �� create summaries of requirements inherent tocreate summaries of requirements inherent to

permits and their identified regulations?permits and their identified regulations? �� modify the way RSO’s are trained?modify the way RSO’s are trained? �� re-structure permit inspection process?re-structure permit inspection process?

What About Other States?What About Other States?

�� Are the trends shown here consistent?Are the trends shown here consistent? �� Are the root causes consistent?Are the root causes consistent? �� Could there be some basic, simpleCould there be some basic, simple

interventions?interventions?

Proposal to OASProposal to OAS

�� To facilitate comparisons,To facilitate comparisons, here’s the dealhere’s the deal:: �� identify number of licensees and averageidentify number of licensees and average

number of NOV’s per permit inspectionnumber of NOV’s per permit inspection �� we’ll calculate an appropriate sample size andwe’ll calculate an appropriate sample size and

sampling strategysampling strategy �� you get the coding forms completedyou get the coding forms completed �� “we” (grad student) will summarize and“we” (grad student) will summarize and

analyze as their research projectanalyze as their research project �� findings provided to you and OASfindings provided to you and OAS

We Need to Stress That We’re AllWe Need to Stress That We’re All in the Same Pool!in the Same Pool!

�� By any measure, theBy any measure, the radiation safety record isradiation safety record is excellent!excellent!

�� This success is due in partThis success is due in part to the inspection process:to the inspection process: hate it or love it, it benefitshate it or love it, it benefits all.all.

�� NOV outcome data can beNOV outcome data can be valuable for preventionvaluable for prevention

�� Emphasize theEmphasize the commoncommon goal and work together togoal and work together to achieve it!achieve it!

��

ReferencesReferences

Emery, R.J., Johnston, T.P., Sprau, D.D., "Simple Physical, Chemical, andEmery, R.J., Johnston, T.P., Sprau, D.D., "Simple Physical, Chemical, and Biological Safety Assessments as Part of a Routine Institutional RadiationBiological Safety Assessments as Part of a Routine Institutional Radiation Safety Survey Program"Safety Survey Program" Health PhysicsHealth Physics , Vol. 69, No. 2, pp. 278-280, 1995., Vol. 69, No. 2, pp. 278-280, 1995.

�� Emery, R.J., Sawyer, R.L., Sprau, D.D., "Assessing the Service ProvidedEmery, R.J., Sawyer, R.L., Sprau, D.D., "Assessing the Service Provided by an Institutional Radiation Safety Survey Program"by an Institutional Radiation Safety Survey Program" Health PhysicsHealth Physics , Vol., Vol. 70, No. 5, pp. 741-743, 1996.70, No. 5, pp. 741-743, 1996.

�� Emery, R.J., Savely, S., "The Benefits of Actively Soliciting WorkerEmery, R.J., Savely, S., "The Benefits of Actively Soliciting Worker Concerns During Routine Safety Inspections"Concerns During Routine Safety Inspections" Professional SafetyProfessional Safety, Vol. 42,, Vol. 42, No. 7, 36-38, 1997.No. 7, 36-38, 1997.

�� Emery, R.J., Pollock, J., Charlton, M., "Notices of Violation Issued toEmery, R.J., Pollock, J., Charlton, M., "Notices of Violation Issued to Texas Radioactive Material Licensees Inspected in 1995",Texas Radioactive Material Licensees Inspected in 1995", Health PhysicsHealth Physics,, Vol. 73, No. 4, 706-709, 1997.Vol. 73, No. 4, 706-709, 1997.

��

References (con’t)References (con’t)

Emery, R.J., "Adding Value to Your Radiation Protection Program", chapterEmery, R.J., "Adding Value to Your Radiation Protection Program", chapter inin Management and Administration of Radiation Safety ProgramsManagement and Administration of Radiation Safety Programs, Medical, Medical Physics Publishing, Madison, WI. 1998.Physics Publishing, Madison, WI. 1998.

�� Emery, R.J., Charlton, M.A., “Assessing the Results of Receipt MonitoringEmery, R.J., Charlton, M.A., “Assessing the Results of Receipt Monitoring Programs for Packages Containing Radioactive Materials”Programs for Packages Containing Radioactive Materials” OperationalOperational Radiation SafetyRadiation Safety, Vol. 77, (, Vol. 77, (Health PhysicsHealth Physics Supplement 1) S5-S9, 1999.Supplement 1) S5-S9, 1999.

�� Emery, R.J., Charlton, M.A., Goodman, G.R., “Texas Radiation SafetyEmery, R.J., Charlton, M.A., Goodman, G.R., “Texas Radiation Safety Program Outcomes as Indicated by Regulatory Compliance Activities fromProgram Outcomes as Indicated by Regulatory Compliance Activities from 1988 to 1997”1988 to 1997” Health PhysicsHealth Physics, Vol. 78, No. 3, 335-342, 2000., Vol. 78, No. 3, 335-342, 2000.

�� Emery, R.J., Charlton, M.A., Mathis, J.L, "Estimating the AdministrativeEmery, R.J., Charlton, M.A., Mathis, J.L, "Estimating the Administrative Cost of Regulatory Noncompliance: A Pilot Method for Quantifying theCost of Regulatory Noncompliance: A Pilot Method for Quantifying the Value of Prevention",Value of Prevention", Operational Radiation SafetyOperational Radiation Safety , Vol. 78 (, Vol. 78 (HealthHealth PhysicsPhysics Supplement 2)S40-S47; 2000.Supplement 2)S40-S47; 2000.