ML20211K214

Threshold for Reportable Event

ML20211K214
Person / Time
Issue date:	09/30/1997
From:	NRC
To:
References
RULE-PR-35-MISC NUDOCS 9710090177
Download: ML20211K214 (14)

Text

I;

\

September 30,1997 THRESHOLD FOR REPORTABLE EVENT NOTE Following Commission approval of the staffs program to revise 10 CFR Part 35 and associated guidance documents, the NRC staff initiated development of draft rule language, using a modality based approach. As directed by the Commission, the staff has developed attematives, with draft rule text, for the more significant issues associated with the regulation of the medical use of byproduct material. These altematives to regulation in specific areas are intended to help focus the discussion during the NRC's public meetings and the meetings with medical professional societies during the Fall of 1997 and to assist the staff in developing the proposed rule language. The alternatives represent a broad range of possibilities and are being

, provided to stimulate input from members of,the public in an effort to encourage all interested parties to provide input into the development of the' revised regulation. The NRC staff has not selected any alternative at this time, and is open to additional altematives which might be proposed that are consistent with the guidance provided by the Commission.

L - H-1 VT4 th e p hA /j.. b,, e l

9710090177 970930 ['

PDR PR PDR l 3S MISC ..

i i' i 1

4_ ). -

c

e' 4

l.

9/29/97 PART 35 - THRESHOLD FOR REPORTABLE EVENT Summarv of Alternatives l

1. Thresholds for reportable event (misadministration) and recordable event remain as

. listed in the current $35.2, with the addition of a statement in the reportable definition to address precursor events that are outside the area defined by the term

. misedministration."

2. Threshold for reportable event is raised to the level of the NRC abnormal occurrence reporting criteria in addition, the definition for reportable event will include a statement to address precursor events that are outside the area currently defined by the term

" misadministration." Threshold for recordable event is raised to the current threshold for

" misadministration."

l

3. Threshold for reportable event is raised to the level of the NRC abnormal occurrence - i reporting criteria, in addition, the definition for reportable event will include a statement l to addrets precursor events that are outside the area currently defined by the term l "misedministration." (No requirement for recordable event.) 1

4. Threshold for reportable event is lowered to the current level of recordable event, with the inclusion of items such as wrong patient, route, or dosage that are not coverso by ,

the current ' recordable event" definition. In addition, the definition for reportable event will include a statement to address precursor events. (No requirement for recordable event.)

5. Thresholds for reportable event and recordable event, if applicable, would be set

, according to the outcome of discussions on Altematives 1,2,3, and 4. Licensees would voluntarily report procursor events that are outside of the area currently defined by the term " misadministration.'

NOTE 1: The term 'misedministration" has been replaced with " reportable event

• in this document.

NOTE 2: In the Staff Requirements Memorandum dated March 20,1997, the Commission

. directed the staff to address how to capture not only relevant safety-significant events, but also procursor events. Staff is considering the development of a regulatory requirement designed to capture precursor events having programmatic implications for radiation safety. This requirement would be intended to identify events, incidents, and situations which have

~

implications for that facility or implications for similar facilities (generic incidents) that may adversely affect the dose to the patient or the public. The objective of this requirement is to identify information that would be useful to avoid potentially significant problems and to improve the radiation safety program at licensed facilities. This requirement should include, but not necessarily be limited to, incidents resulting from mechanical, structural or electrical malfunction of a system, as well as events resulting from procedural errors or human error. Examples of 1

l o precursor events might include failure of an interlock system, malfunction of a timer system, failure of a brachytherapy treatment device to contain a source, or mislabelling of a radiopharmaceutical.

i NOTE 3: Several of the alternatives presented in this document would base the reportable )

i level on the NRC abnormal occurrence (AO) reporting criteria. The AO statement of policy

contains criteria that are set at a level required to keep Congress and the public informed of

)

unscheduled incidents or events which the Commission consisers significant from the standpoint c' public health and safety. Therefore, AO levels are set above the normallevel of reporting to NRC to exclude those events that involve some variance from regulatory limits, but are not significant from the standpoint of public health and safety, if the AO criteria are used as a basis for the reportable threshold, the actual reportable threshold would have to be some percentage of the AO criteria, i l

l l

l 4

2

l' i CURRENT DEFINITIONS / REQUIREMENTS Status Quo Recordable Status Quo Reportable (Recordable Event $35.2) (Misadministration 635.2)

All diagnostic radio . . . . . . . . . . . . . . . . . . . . . . . . Wrong patient, radiopharm..

pharmaceuticals (including < 30pC route, or dosage; and Nal,1125 or 1131). . Dose >5 tom EDE or 50 rem to organ.

Sodium lod 6de radio . Admin. dosage differs by $10% . Wrong patient.

pharmaceuticals (where $30 pCl prescr. dosage and >15pCl. . Wrong radiopharmaceutical.

Nal.125 or 1131). . W/o wntten directive. . Admin. dosage differs by >20% 1

. W/o daily dosage record. prescr. dosage and >30 pCl. )

l Therapeutic radio . Admin. dosage differs by >10% . Wrong patient.

pharmaceuticals, prescr. dosage. . Wrong mode of transport. .

. W/o written directive.... .. ..... .. .. . . Wrong route of admin.

. W/o daily dosage record..... . ..... . . Admin. dosage differs by >20%

prescr. dosage.

Teletherapy. . Calculated weekly dose 15% > . Wrong patient.

prescr. dose. . Wrong mode of treatment.

. W/o written directive. . Wrong treatment site.

. W/o daily dose record. . Calculated weekly dose 30% >

l preset, dose.

. Calculated total dose differ 9 t'y

>20% total prescr. dose.

. If <3 fractions, calc. total dose differs by >10% total prescr. ,I dose.

Brachytherapy. . Calc. dose differs by >10% prescr. . Wrong patient, dose. . Wrong radioisotope.

. Wlo written directive. . Wrong treatrnent site.

. W/o daily dose record. . l.eaking source.

. Failure to remove source for a temporary implar,t.

, , Calculated admin. dose differs by

>20% prescr. dose.

Gamma stereotactic radiosurgery. . W/o written directive. . Wrong patient.

. W/o daily dose record. . Wron; treatment site.

. Calculated total admin, dose deffers by >10% total prescr.

dose.

Abnormal occurrence event criteria Misadministration (Management Directive 0.1):

a. Results in a dose that is (1) equal to or greater than 1 gray (Gy) (100 rad) to a major portion of the bone marrow, to the lens of the eye. or to the gonads, gt (2) equal to or greater than 10 Gy (1000 red) to any other organ; AND

b. Represents either (1) a dose or dosage that is at least 50 percent greater than that prescribed in a written directrve og (2) a prescribed dose or dosage that is (I) the wrong pharmaceutical, (ii) delivered by the wrong route of administration, (iii) delivered to the wrong treatment site, (iv) delivered by the wrong treatment mode, or (v) from a leaking source (s).

3

Q ALTERNATIVE 1: Thresholds for reportable event (misadministration) and recordable event remain as listed in the current 35.2, with the addition of a statement in the reportable definition to address precursor events that are outside the area defined by the term " misadministration."

Pms

1. Regulatory requirement for licensee to identify and/or report or record, as appropriate, events. This information may be used to increase the overall effectiveness of the radiation safety program.

2. Provides licensee with tiered approach to event reporting or recording depending on the nature of the event.

3. Enables NRC to identify the causes of events and help identify precursor events (SRM DSl 7) in order to correct them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally).

4. Enables NRC to fulfill its statutory obligation (in Section 208 of The Energy Reorganization Act of 1974) to report abnormal occurrences (AOs) to Congress.

5. Licensees are familiar with current definition, therefore it would only be :,0cessary to change current operating procedures to identify and report precursor events.

CQna

1. Requirement for multiple action points (reportable and recordable) may be considered prescriptive.

2. Requirement may be considered as intruding into thri area of patient confidentiality if the patient's name or identification is included in the report or record.

3. Reporting of precursor events may not be justified by risk associated with the potential for exposure and may result in an increased burden on licensees.

4. Reporting of precursor events may result in a large volume of reports, requiring a significant expenditure of NRC resources for evaluation of low risk events.

5. Specific rule language and guidance (examples) will need to be developed to identify precursor events.

4

s' l

L Suggested Rule Text Status Quo Recordable Status Quo Reportable (Recordable Event $35.2) (Misadministration $35.2)

All diagnostic radio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Wrong patent, radiopharm.,

pharmaceuticals (including < 30pC route, or dosage; and Nal,1125 or 1131). . Dose >5 rom EDE or 50 rem to organ.

Sodiumlodido radio . Admin. dosage differs by >10% . Wrong patient.

pharmaceuticals (where >30 pCl prescr. dosage and >15pCl.- . Wrong red 60pharmaceut6 cal.

Nal 125 or 1131). .W/o written directive. . Adm6n. dosage differs by >20% -!

.W/o delly dosage record. prescr. dosage and >30 pCl.

. Therapeutic radio . Admin. dosage differs by >10% . Wrong patient.

piermaceuticals, prescr. dosage . . . Wrong mode of transport.

. W/o written directive.- . Wrong route of admin.

. W/o daily dosage record. . Admin. dosage differs by >20%

prescr. dosage Telethorapy. . Calculated weekly dose 15% > . Wrong pahent.

prescr. dose. . Wrong mode of treatment.

. W/o written directive. . Wrong treatment site.

. W/o daily does record. . Calculated weekly dose 30% >

prescr. done.

. Calculated total dono differs by

>20% total prescr. done.

. If <3 fractions, calc. total dose differs by >10% total prescr.

dose.

Brachytherapy. . Calc. dose differs by >10% prescr. . Wrong patient dose. . Wrong radioisotope

. W/o written dirochve. . Wrong treatment sitec

.W/o daily dose record . l.eeking source.

. Failure to remove source for a temporary impiant

. Calculated admin. dose ddfors by

>20% prescr.- dose.

Gamma storeotactic radiosurgery. .W/o written directive. . Wrong patient

. W/o daily does record . Wrong treatment site.

. Calculated total admin dose differs by >10% total prescr.

dose.

Additional requirement for reportable events:

Statement to address procursor events (reference NOTE 2, page 1).

5

l ALTERNATIVE 2: Threshold for reportable event is raised to the level of the NRC abnormal l occurrence reporting criteria. In addition, the definition for reportable event willinclude a statement to address precursor events that are outside the area currently defined by the term

" misadministration." Threshold for recordable event is raised to the current threshold for "misadmireistration."

P. Inn i

1. Regulatory requirement for licensee to identify and/or report or record, as appropriate, l events. This information may be used to increase the overall effectiveness of the radiation safety program.

2. Provides licensee with tiered approach to event reporting and recording, depending on the nature of the event.

3. Enables NRC to identify the causes of events and help identify precursor events (SRM DSI 7) in order to correct them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally).

4. Enables NRC to fulfillits statutory obligation (in Section 208 of The Energy I Reorganization Act of 1974) to report abnormal occurrences (AOs) to Congress.

5. Abnormal occunence event reporting criteria are risk based.

CDDS

1. Requirement for multiple action points (reportable and recordable) may be considered prescriptive.

2. Requirement may be considered as intruding into the area of patient confidentiality if the patient's name or identification is included in the report or record.

3. Reporting of precursor events may not be justified by risk associated with the potential for exposure and may result in an increased burden on licensees.

4. Reporting of precursor events may result in a large volume of reports, requiring a significant expenditure of NRC resources for evaluation of low risk events.

5. Specific rule language and guidance (examples) will need to be developed to identify precursor events.

6. Licensees would have to change current operating procedures to identify and report precursor events.

6

O t

Suggested Rule Text

! Recordable Event:

All diagnostic radio . Wrong patient, radiopharm.. route, or pharmaceu cals (including < 30pC dosage; and Nal,1125 or 1131). . Dose >5 rem EDE or 50 rem to organ.

I Sodium iodide radio . Wrong patient.

l pharmaceuticals (where $30 pCl . Wrong radiopharmaceutical.

l Nel-125 or 1131). . Administered dosage drflers by >20%

l prescribed dosage and >30 pCl.

l l Therapeutic radio . Wrong patient.

l pharmaceuticals. . Wrong mode of transport.

. Wrong route of admin.

. Administered dosage differs by >20%

prescribed dosage.

Telethorapy. . Wrong patient. l t

l

.Wrorn mode of treatment.

. Wrong ,'roatment site,

. Calculate t weekly dose 30% > prescribed dose. l

. Calculated total dose detfers by >20% total prescribed dose.

. If <3 fractions, calculated total dose differs by

>10% total prescribed dose.

Brachytherapy, . Wrong patient.

. Wrong radioisotope

. Wrong treatment site.

. Leaking source.

. Failure to remove source for a temporary _

implant.

. Calculated administered done differs by

>20% prescribed done, Gamma stereotactic radiosurgery. . Wrong patient, l *

. Wrong treatment site,

. Calculated total administered dose differs by >10% total prescribed dose.

Reportable Event:

a. Results in a dose that is (1) equal to or greater than i gray (Gy) (100 red) to a major port 6on of the bone marrow, to ths lens of the eye, or to the gonads, gg (2) equal to or greater than 10 Gy (1000 red) to any other organ; AND b, Represents either (1) a dose or dosage that is at least 50 percent greater than that prescribed in a written directive et (2) a prescribed dose or dosage that is (i) the wrong pharmaceutical, (ii) delivered by the wrong route of administration, (iii) delivered to the wrong treatment site, (iv) delivered by the wrong treatment modo, or (v) from a leaking source (s),

c. Statement to address precursor events (reference NOTE 2, page 1),

7

ALTERNATIVE 3: Threshold for reportable event is raised to the level of the NRC obnormal occurrence reporting criteria. In addition, the definition for reportable event willinclude a statement to address precursor events that are outside the area defined by the term

" misadministration." (No requirement for racordable event.)

P_tos

1. Regulatory requirement for licensee to identify and/or report, as appropriate, events.

This information may be used to increase the overall effectiveness of the radiation

safety program.

l 2. Enables NRC to identify the causes of events and help identify precursor events (SRM DSI 7) in ordor to correct them and prevent recurrence (isolated incidents can reveal a generic problem when compared nationally).

3. Enables NRC to fulfillits statutory obligation (in Section 208 of The Energy Reorganization Act of 1974) to report abnormal occurrences (AOs) to Congress.

4. Abnormal occurrence event reporting criteria are risk based.

S. The regulation would be simplified because there would be only one paperwork requirement, i.e., only reportable events.

C0118

1. Requirement may be considered as intruding into the area of patient confidentiality if the patient's namo or identification is included in the report.

2. Reporting of precursor events may not be justified by risk associated with the potential for exposure and may result in an increased burden on licensees.

3. Reporting of precursor events may result in a large volume of reports, requiring a

' significant expenditure of NRC resources for evaluation of low risk events.

4. Misadministrations that do not meet the reporting criteria or the criteria for a precursor event will no longer be reported to NRC, S. Specific rule language and guidance (examples) will need to be developed to identify precursor events.

6. Licensees would have to change current operating procedures to identify and report precursor events.

8

e,- .  ;

Suggested Rule Text:  ;

i Reportable Event:

a. Results in e dose that is (1) equal to or greater than i gray (Gy) (100 red) to a major portion of the  ;

bone rnarrow,is the lens of the eye, or to the gonads, gg (2) equal to or greater than 10 Gy (1000 red) to any other organ; AND  ;

f,

b. Represents either (1) a dose or dosage that is at least 60 percent greater than that prescribed in a l written drective og (2) a prescribed dose or dosage that (l) la the wrong pharmaceutical, or (ii) is delivered by the wrong route of administration, or (iii) is d6isy9tpd to the wrong treatment site, or (iv) is ,

delivered by the wrong treatment mode, or (v) is from a leaking source (s),

c. Statement to address precursor events (reference Note 2, page 1 ).

.. j i

i 9

0 0 9

'-<..--e- ,r -~,-.ie - , - , .wo-,-,m--u-- -,e,:~,3 --. . , -.--.. ,,,.w-.. -,.7--.-w,,w., m , - , . , -., -. , 1,..m,, e m. . -- or,-.mm---- ww-e-,

ALTERNATIVE 4: Threshold for reportable event is lowered to the current level of recordable evsnt, with the inclusion of items such as wrong patient, route, or dosage that are currently not covered by the current ' recordable event

• definition. In addition, the definition for reportable event willinclude a statement to address precursor events. (No requirement for recordable event.)

Er.Qs

1. The regulation would be simplified because there would be only one paperwork requirement i.e., only reportable events.

2. Regulatory requirement for licensee to identify and/or report events. This information may be used to increase the overall effectiveness of the radiation safety program.

l 3. Enables NRC te. Identify the causes of events and help identify precursor bents (SRM DSI 7) in or6r to correct them and prevent recurrence (isolated incidents can reveal a generic r :oblem when compared nationally).

4. Enables NRC to fulfillits statutory obligation (in Section 208 of The Energy Reorganization Act of 1974) to report abnormal occurrences (AOs) to Congress.

CQna

1. Requirement may be considered as intruding into the area of patient confidentiality if the patient's name or identification is included in the report.

2. Lowering the threshold for reporting events and reporting of precursor events may not be justified by risk associated witn the potential for exposure and may result in an undue burden on licensees.

3. Lowering the threshold for reporting events and reporting of precursor events may result in a large volume of reports, requiring a significant expenditure of NRC resources for evaluation of low risk events. .

4. Specific rule language and guidance (examples) will need to be developed to identify precursor events,

5. Licensees would have to change current operating procedures to identify end report precursor evente.

10 2 -

l L.;

Suggested Rule Text 1

- Reportable Event:

All diagnostic radiopharm . Wrong patient, radiopharm.. toute, or dosage.

(6ncluding < 30pC Nat.1126 or

.1131).

Sodium lodido radiopharm (where . Wrong patent.

>30 pCI Nal.126 or 1131. . Wrong radghermaceutical.

. Admin. dosage deffers by >10% prescr. dosage and >15pCl.

. W/o written directive.

. W/o daily dosage record.

Therapeutic radioparm. . Wrong patient.

. Wrong inode of transport.

. Wrong route of administration.

. Admin. dosage differs by >10% prescribed dosage.

. W/o written directive. ,

. W/o daily dosage record. l 1

Telethorapy. . Wrong patient. -l

. Wrong mode of treatment  !

. Wrong treatment ette. . i

. Calculated total dose differs by >20% total prescribed done, ,

. If <3 fractions, calculated total dose deffers by >10% total j prescribed dose. '

. Calculated wookh dose 16% > prescribed dose.  ;

.W/o written directive, i

.W/o daily does record Brachytherapy. . Wrong patient.

. Wrong radiomotope,

. Wrong treatment ette.

. Leaking source.

. Failure to remove source for a temporary implant.

. Calc. does differs by >10% prescribed dose. -

.W/o written dwoctive .

. W/o daily does record.

Gamma etereotactic radiosurgery. . Wrong patient.

.- Wrong treatment site.

~. Calculated total admin. done differs by >10% total prescribed dose.

. W/o written directive.

. W/o daily done record.

Additior.cl requirement for reportable events:

Statement to address procursor events (reference NOTE 2, page 1),

11

Q*

l-ALIERNArlVE 5; Thresholds for reportable event and recordable event,if applicable, would I be a tt according to the outcome of discussions on Alternatives 1,2,3, and 4. Licensees would voluntarlty report precursor events that are outside of the area currently defined by the term

%lsadministration.'

P.IDA

1. Relies on voluntary standard 1:.r reporting of precursor events that do not meet the dose threshold for reportable or recordable events.

2. Voluntary reporting system may perrait NRC to capture precursor events reported to other agencies or organizations anJ thus reduce duplicative reporting by licensees. ,

3 Consistent with SRM on DSI 7 to rely on voluntary standards when ...... appropriate.

CODA

1. NRC and licensee resources would be required to develop a mechanism to capture precursor events.

2. Inconsistent application of voluntary standard may result in NRC not being informed of some precursor events.

Suggested Rule Text The rule text would either be the suggested text in alternative 1,2, 3, or 4, but with a statement to address voluntary reporting of precursor events.

12

OVERVIEW OF THRESHOLD FOR REPORTABLE EVF J Key items for Consideration I, Alt. Alt. /ft.

1 2 3 4 Regulatory requirement for licensee to identify and/or report or x x x x record, as appropriate, events.

Enables NRC to ident:fy the causes of events and help identify x x x x precursor events (SRM DSI 7) in order to correct them and prevent recurrence (isolated incidents cati reveal a generic problem when compared nationally).

Enables NRC to fulfillits statutory obligation (in Section 208 of x x x x The Energy Reorganization Act of 1974) to report abnormal occurrences (AOs) to Congress.

Requirement for multiple action points (reportable and x x recordable) may be considered presc,iptive.

Requirement may be considered as intruding into the area of x x x x patient confidentiality if the patient's name or identification is included in the report or record.

Reporting of precursor events may not be justified by risk x x x x associated with the potential for exposure and may result in an increased burden on licensees.

Reporting of precursor events may result in a large volume of. x x x x reports, requiring a significant expenditure of NRC resources for evaluation of low risk events.

Specific rule language and guidance (examples) will need to x x x x be developed to identify precursor events.

• Key items are not identified for Altemative 5 because the exact pros & cons will depend on which Alternative is used with the voluntary reporting of precursor events.

13

.