ML20198L863

Training & Experience

ML20198L863
Person / Time
Issue date:	09/30/1997
From:	NRC
To:
Shared Package
ML20198L846	List: IA-97-358, Notice of Workshop Re 10CFR35, Medical Use of Byproduct Matl ML20198L841 ML20198L863 ML20198L872 ML20198M223
References
FOIA-97-358 NUDOCS 9710270196
Download: ML20198L863 (23)

Text

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t September 30,1997 TRAINING AND EXPERIENCE NOTE l

l l

l Following Commission approval of the staff's program to revise 10 CFR Part 35 and asso :iated guidance documents, the NRC staff initiated development of draft rule langt age, using a modality-based approach. As directed by the Commission, the staff has developed alternatives, with draft rule text, for the more significant issues associated with the regulation of the medical use of byproduct material. These alternatives 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 allinterested 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 alternatives which might be proposed that are consistent with the guidance provided by the Commission, w,

9710270196 971022 PDR FOIA ROSE 97-358 PDR t li v c7 l-we r ,

9/29/97 PART 35.TitAINING AND EXPERIENCE Summary.of Alternatives - Authorized User

1. Status quo (i e., M.D. + Board certification or specified number of hours of training and experience).

2. M.D. + Board certification or specified number of hours of training and experience (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience). Note, the specific board certifications will not be listed in the ,

rule, but instead will be a certification that is approved by the NRC.

3. M.D. + Board certification or specified number of hours of training (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience) + exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

4. M.D. only.

5. M.D. + exam.

L 6. M.D. + exam + clinical experience.

I NOTES The Altematives represent various combinations of training and experience criteria that could be used to demonstrate that an authorized user can receive, possess, use, and transfer radioactive material consistent with radiation safety practices and in accordance with the regulations.

These key elements are listed below with a reference to the Attemative that incorporates the element.

1. Is it necessary to state the need for clinical experience in the training and experience requirement? If yes, ang Alternatives 1,2,3, and 6.

2. How should a potential authorized user demonstrate that they have obtained knowledge about the safe handling of radioactive material?

a. If by industry certification (e.g., American Board of Nuclear Medicine, American Board of Radiology, etc.), see Alternatives 1,2, and 3.

b. If by radiation safety exam, seg Alternatives 3,5, and 6.

1

ALTERNATIVES AVAILABLE FOR EACH MODALITY Attemative 1 Altemative 2 Altemative 3 Attemative 4 Altemative 5 Afternative 6 Low Dose / / / / / /

Unsealed Diagnostic High Dose / / / No / /

Unsealed Low Dose / / / No / /

Sealed Brachy-therapy Low Dose / / / / / /

Sealed Diagnostic Teletherapy / / / No / /

HDR / / / No / /

Gamma Knife / / / No / /

Emerging / / / / / /

Technology 2

ALTERNATIVE 1: Status quo (i.e., M.D. + Board certification or specified number of hours of training and experience).

PLQ1 .

1. More than one means to meet authorized user criteria.

2. Modality specific.

3. Easy to use if board certified by a board listed or if have completed a training program.

4. Assures that user has radiation safety training if training hour option is pursued.

5. Has a clinical experience component, C211 l

l 1. Reference to a training program that is not in existence [e.g ,35.910(c) - six month training program).

2. Limits approval to boards specifically listed and must amend regulations to add or delete a board.

3. Training hours required may not accurately reflect the risk of the modality (i.e., not risk based).

4 No process developed for periodic review and assurance of certifying board standing.

5. NRC must review / accept any certifying boards not listed.

6. Requiring hours in radiation safety training does not assure understanding of radiation safety.

Current Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:

(a) is certified by:

(1) The American Board of Nuclear Medicine; (2) The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; (3) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or (4) The American Osteopathic Board of Radiology after 1984; or l 3

(b) Has had classroom and laboratory training in basic radioisotope handling techniques

- applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows:

(1) 80 hourb of classroom and laboratory training that includes:

(1) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measuremont of radioactivity; and (iv) Radiation biology; and (2) Supervised clinical experience under the supervision of an authorized user at a medical

institution that includes: ,

(1) Use of iodir.e-131 for d;agnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and (ii) Use of iodine-131 for treatment of thyroid carcinoma in 3 individuals.

4

6LTERNATlyE2. M.D. + Board certification or specified number of hours of training and experience (with a change in the number of hours to focus on radiates safety, with minimal

quirements for clinical experience). Nots, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

I ELDA

1. More than one mt;ns to meet authorized user criteria.

2. Modality specific.

3. Easy to use if board certified or if have completed a training program.

4. Emphasis on Ndiation safety for the number of hours of training required (i.e., risk based if

. the number of hcurs required increases as the risk of the modality increases). '

S. Board changes do not require rulemaking.

6. Assures that user has radiation safety training if training hour option is pursued.

7. Clinical experience component is included.

G

1. NRC must review / accept certifying board

2. A mechanism must be developed to notify the public of the NRC accepted boards.

3. No process developed for periodic review and assurance of certifying board standing.

4. Requiring hours in radiation safety training does not assure understanding of radiation safety.

Draft Rule Text The licenses shall require the authorized user of radiopharmaceuticals in Section 35.300 tc, be a physician who:

(a) is certified by a medical specialty board whose certification process includes all r,f the training and experience requirements in Section 35.930(b) and whose certification has been accepted by the NRC; or (b) Has completed hours of training (e.g., QC hours) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals; and has had supervised radiopharmaceutical administration experience.

(1) The classroom and laboratory training shall include:

5

(l) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology.

(2) The supervised work experience under the supervision of an authorized user shall include:

(l) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instrumente t.1d performing checks for proper operation of survey meters; (lii) Calculating and safely preparing patient or human research subject dosages; (iv) Using administrative controls to prevent the misadtninistration of byproduct material; (v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures.

(3) The supervised radiopharmaceutical administration expedence under the supervislor of an authorized user at a medica' institution shall include:

(l) Oral administration in 10 individuals of iodine 131 or diagnostic studies (involving -

dosages of sodium lodide 1 131 in quantities greater than 30 microcuries) or for treatment of hyperthyroidism or cardiac dysfunction; or (ii) Parenteral administration in 3 individuals of: phosphorus 32 for treatment of myeloproliferative disorders or intracavitary cancer; or strontium 8g or samarium 153 for treatment of bone metastasis; and (iii) Oral administration in 3 individuals of lodine 131 for treatment of thyroid carcinoma.

6

ALTERNATIVE 3: M D. + Board certification or specified number of hours of training (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience) + exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

P19.a

1. More than one means to meet authorized user enteria.

2. Modality specific.

3. Easy to use if board certified.

4. Emphasis on radiation safety for the number of hours of training required (i.e., risk based if the number of hours required increases as the risk of the modality increases).

5. Board changes do not require rulemaking.

6. Standardized method for testing a baseline of awareness / knowledge.

7. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).

8. Clinical experience component is included.

C_Qnt

1. NRC must review / accept certifying board.

2. A mechanism must be developed to notify the public of the NRC accepted boards.

3. Process required for periodic review and assurance of certifying board requirements.

4. Resource intensive to develop and administer exam and maintain testing program.

5. Added expense to person taking exam (e.g., cost to travel to exam location).

Draft Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:

(a) is certified by examination by a medical specialty board whose certification process includes all of the training and experience requirements in Section 35.930(b) and whose certification has been accepted by the NRC; or (b) Has completed hours of training (e.g.,120 liours) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable 7

to the une of theraoeutic radiopharmaceuticals; has had supervised radiopbmaceutical adminimatiori experience; and has demonstrated sufficient knowledge !n radiation safety commt Ourate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission. ,

(1) The classroom and laboratory training shallinclude:

(l) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology.

(2) The supervised work experience under the supervision of an authorized user shall include:

(l) Oruering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performinp checks for proper operation of survey meters;

('i) Calculating and safely preparing patient or human research subj6d dostges; (iv) Using administrative controls to prevent the misadministration of byproduct material; and (v) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures.

(3) The supervised radiopharmaceutical administration experience under the supervision of an authorized user at a medical institution shall include:

(1) Oral administration in 10 individuals of iodine 131 or diagnostic studies (involving dosages of sodium iodide 1131 in quantities greater than 30 microcuries) or for treatment of hyperthyroidism or cardiac dysfunction; or (ii) Parenteral administration in 3 individuals of: phosphorus 32 for treatment of myeloproliferative disorders or intracavitary cancer; or strontium-89 or samarium 153 for treatment of bone metastasis; and (iii) Oral administration in 3 individuals of iodine 131 for treatment of thyroid carcinoma.

8

?.

l ALTERNATIVE 4: M.D. only.

Pas i

1. No NRC specified training required to practice medicine using radioactive material.

2. Easier to approve authorized users.

3. Licensee is given complete latitude to review and determine the radiation safety and .

l modality specific qualifications of a practitioner.

4. Supports a highly performance based approach.  ;

CQDA

1. May not accurately reflect rish of modality (i.e., not risk based).

2. No assurance that user has received radiation safety training.

3. No specific clinical experience required. This may not accurateiy reflect the r4k of the modality (i.e., not risk based).

Draft Rule Text:

The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician.

9

ALTERNATIVE 5: M.D. + exam, ELDA

1. Modality specific if tailor test to each modality.

2. Standardized method for testi S) a baseline of awareness / knowledge.

3. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).

4. No NRC specified training required to practice medicine using radioactive material.

t CDDI

1. Resource intensive to develop and administer exam and maintain testing program.

I

' 2. Added expense to person taking exam (e.g., cost to travel to exam location),

3. No specific clinical experience required. This may not accurately reflect the risk of the modality (i.e., not risk based).

4. Relies on exam results to show that individual has received appropriate radiation safety training.

QtafLBule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician and has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

10

r__ . _ - _ _ _ _ _ _ _ _ _ _ - _ - _ _ _ _ _ _ _

l5 l

ALTERNATIVE 6: M.D. + exam + clinical experience.

D

1. Modality specific if tailor fest and experience to each modality.

2. Standardized method for testing a baseline of awareness / knowledge, 1

3. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).

4. Clinical experience component is included.

CQal (

1. Resource intensive to develop and administer exam and maintain testing program.

2. Added expense to person taking exam (e.g., cost to travel to exam location).

3. Relies on exam results to show that individual has received appropriate radiation safety training.

Draft Rule Text l

The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:

(a) Has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission; and (b) Has had supervised radiopharmaceutical administration experience. The supervised radiopharmaceutical administration experience under the supervision of an authorized user at a medical institution shallinclude:

(1) Oral administration in 10 individuals of iodine 131 or diagnostic studies (involving dosages of sodium iodide 1131 in quantities greater than 30 microcuries) or for treatment of hyperthyroidism or cardiac dysfunction; or (2) Parenteral administration in 3 individuals of; phosphorus 32 for treatment of myeloproliferative disorders or intracavitary cancer; or strontium 89 or samarium 153 for treatment of bone metastasis; and (3) Oral administration in 3 individuals of iodine 131 for treatment of thyroid carcinoma, 11

l .:

AUTHORIZED USER OVERVIEW ALTERNATIVES KEY ITEMS FOR CONSIDERATION 1 2 3 4 5 6 More than one means to meet training and experience X X X criteria.

Modality specific. X X X X X Easy to use if board certified. X X X Emphasis on radiation safety training when training and X X experience required. (i.e., risk based)

Board changes do not require rulemaking. X X _

Standardized method for testing a baseline of training and X X X experienco.

Licensee given complete latitude to review and approve X users.

Resource intensive to develop and administer exam. X X X Added expense to person taking exam. X X X Added assurance that tested individualis aware of radiation X X X safety issues.

Clinical experience component included. X X X X 12

Summarv of Alternatives Radiation Safety Officer

1. Status quo (i.e., Board certification or specified number of training hours along with one year of training under an RSO or identified as an authorized user on a license).

2. Board certification by a board approved by the NRC or specified number of training h urs to -

include experience with the types and forms of radioactive material to be used at the facility.

Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

3. Board certification by a board approved by the NRC or specified number of training hours to irclude experience with the types and forms of radioactive material to be used at the facility

+ exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

4. Exam only.

5. One year of full tirre experience at a medicalinstitution under the supervision of a radiation safety officer + exam.

i l

13

ALTERNATIVE 1: Status quo (i.e., Board certification or specified number of training hours along with one year of training under an RSO or identified as an authorized user on a license).

P.ma

1. More than one means to meet RSO criteria.  ;

2. Easy to use if board certified oy a board listed or if named as an authorized user on a license.

3. Assures that RSO has radiation safety training if training hour option is pursued.

CD118 1, Not risk based. Same training requirement regardless of level of use.

2. Assumes that an authorized user has sufficient radiation safety training.

3. Limits to specific boards listed in the rule and must amend regulations to add or delete boards.

4. Number of hours specified may not accurately reflect the risk of each modality.

5. NRC must raview/ accept any certifying boards not listed.

6. Requiring hours in radiation safety training does not assure understanding of radiation safety.

Current Rule Text:

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in Section 35.32 to be an individual who:

(a)is certified by:

(1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology; (3) American Board of Nuclear Medicine; (4) American Board of Science in Nuclear Medicine; (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy; (6) American Board of Medical Physics in radiation oncology physics; (7) Royal College of Physicians and Surgeons of Canada in nuclear medicine; (8) American Osteopathic Board of Radiology; or (9) American Osteopathic Board of Nuclear Medicine; or 14

(b) Has had classroom and laboratory training and experience as follows:

(1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includes:

(1) Radiation physics and instrumentation; (ii) Radiation protection;

- (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology; and (v) Radiopharmaceutical chemistry; and (2) One year of full time experience as a radiation safety technologist at a medical institution under the supervision of the individualidentified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material; or-(c) Be nn authorized user identified on the licensee's license.

15

ALTERNATIVE 2; Board certification by a board approved by the NRC or specified number of training hours to include experience with the types and forms of radioactive material to be used at the facility. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

Pms

1. More than one means to meet RSO cnteria.

2. Modality specific if experience ed training hours are tailored for each modality.

3. Easy to use if board certified.

I

4. Board changes do not require rulemaking.

5. Assures that RSO has radiation safety training if training hour option is pursued.

l l D

1. NRC must review / accept certifying board.

2. A mechanism must be developed for notifying the public of NRC accepted boards.

3. To approve an authorized user to be RSO, the AU must meet the specified RSO criteria.

4. Requiring hours in radiation safety training does not assure understanding of radiation safety.

Draft Rule Text:

The censes shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in Section 35.32 to be an individual who:

(a) is certified by a specialty board whose certification process includes all of the training and experience requirements in Section 35.900(b) and whose certification has been accepted by the NRC; or (b) Has completed hours of training (e.g.,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) that includes classroom and laboratory training and supervised vrork experience, in basic radioisotope haridling techniques applicable to the type and forms of radioactive material to be used. .

(1) The classroom and laboratory training shall include:

(1) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology; (v) Radiopharmaceutical chemistry.

16

\

i

- (2) Tne supervised work experience, under the supervision of a Radiation Safety Officer on a Commission or Agreement State license that authorizes the use of byproduct material similar to the use requested shallinclude:

l (1) Authorizing the purchase of radioactive material; (ii) Receiving and opening packages of radioactive material; (iii) Storing radioactive material; (iv) Keeping an inventory record of radioactive material; (v) Using radioactive material safely; (vi) Taking emergency action if control of radioactive materialis lost; (vii) Performing periodic radiation surveys; l (viii) Performing checks of survey instruments and other safety equipment;

- (ix) Disposing of radioactive material; and (x) Training personnel who work in or frequent areas where radioactive mate ialis used or stored.-

17

9 6LTERNATIVE 3: Board certification by a board approved by the NRC or specified number of training hours to include experience with the types and forms of radioactive material to be used at the facility + exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

i P_LOS

1. More than one means to meet RSO criteria.

2. Modality specific if experience and training hours are tailored for each modality.

3. Easy to use if board certified.

4. Board changes do not require rulemaking.

5. Standardized method for testing a baseline of awareness / knowledge.

l l

6. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).

C.QDS

1. NRC must review / accept certifying board.

2. A mechanism must be developed for notifying the public of NRL accepted boards.

3. To approve an authorized user to be RSO, the AU must meet the specified RSO criteria.

4. Resource intensive to develop and administer exam and maintair. testing program.

5. Added expense to Mrson taking exam (e g., cost to travel to exam location).

Draft Rule Text:

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who:

(a) Is certified by examination by a specialty board whose certification process includes all of the training and experience requirements in Section 35.000(b) and whose certification has been accepted by the NRC; or (b) Has completed hours of training (e.g.,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable to the type and forms of radioactive material to be used; and has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

(1) The classroom and laboratory training shallinclude:

18 i

(1) Radiation physics and instrumentation; (ii) Radiation prot 3ction; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology; (v) Radiopharmaceutical chemistry.

(2) The supervised work experience, under the supervision of a Radiation Safety Officer on a Commission or Agreement State license that authorizes the use of byproduct material similar to the use requested shallinclude:

(i) Authorizing the purchase of radioactive material; (ii) Receiving and opening packages of radioactive material,  !

(iii) Storing radioactive material; j (iv) Keeping an inventory record of radioactive (nattrial; l (v) Using radioactive material safely; (vi) Taking emergency action if control of radioactive materialis lost; (vil) Performing periodic radiation surveys; (viii) Performing checks of survey instruments Lnd other safety equipment; '

(ix) Disposing of radioactive material; and (x) Training personnel who work in or frequent areas where radioactive material is used or stored.

l 19

e ALTERNATIVE 4: Exam only.

PRA l 1. Modality specific if tailor test to each modality.

2. Standardized method for testing a baseline of awareness / knowledge.

3. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).

CDDt

1. Resource intensive to develop and administer exam and maintain testing program.

2. Added expense to person taking exam (e.g., cost to travel to exam location).

3. Relies on exam results to show that individual has received appropriate radiation safety training.

4. To approve an authot; zed user to be RSO, the AU must meet the specified RSO enteria.

Draft Rule Text:

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

20

ALTERNATIVE 5. One year of fa# time experience at a medicalinstitution under the supervision of a radiation safety officer + exam.

Ef28

1. Assures that RSO has radiation safety training at a medicalinstitution.

2. Standardized method for testing a baseline of awareness / knowledge.

3. Added assurance that tested individualis aware of radiation safety issues.

CDDE

1. Not risk based. Same training requirement regardless of level of use.

2. Amount of time specified may not accurately reflect the risk of each modality, i

3. Resource intensive to develop and administer exam and maintain testing program.

4. Added expense to person taking the exam.

Draft Rule Text:

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who:

(a) Has completed one year of full time experience at a medical institution under the supervision of the individualidentified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material and, (b) Has demonstrated sufficient knowledge in the radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

21

__9

Summarv of Alternatives Authorized Phvalcist and Authorized Nuclear Pharmacla!

Altematives for training and experience are t imilar to the alternatives provided for the radiation safety officer, except for the text discussing an authorized user requesting to be listed as a radiation safety officer. However, care must be taken to ensure that the training and experience for physicists is commensurate with the type of physics performed.

f 22

September 30,1997 i

QUALITY MANAGEMENT PROGRAM  ;

1 NOTE Following Commission approval of the staff's program to revise in 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 alternatives, with draft rule text, for the more significant issues associated with the regulation of the medical use of byproduct material. These '

alternatives 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 ptoposed 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 i 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 alternatives which might be proposed that are consistent with the guidance provided by the Commission.

m l'

[ d D f C 2,V p

9/29/97 I PART 35. QUALITY MANAGEMENT PROGRAM  ;

Summarv of Alternatives

1. Maintain current requirements in S35.32.

2. Only require a written quality management program.

3. Require written quality management program, retain each written directive and a record of each dosage requiring a wntten directive, a,1d perform audits.

4. Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and maintain a record of recordable events.

NOTE: Section 6 of the SRM dated, March 20,1997, states:

[ Staff should consider...)

The Quality Management Program provisions (10 CFR Part 35.32) should be re.

evaluated and revised to focus on those requirements that are essential for patient safety, e.g. confirming patient identity, requiring written prescriptions and verifying dose.

To the maximum extent possible, the requirements should be revised to be risk informed. Given this objective, a mixed approach of performance based rules and otherwise prescriptive regulations should be pursued.

Section 4 of the SRM dated, March 20,1997, states:

[ Staff should consider...)

Changing the nomenclature from " misadministration" to " medical event" or comparable terminology.

1

.- _ _ _ ~ _ _.. _ -.. . - _ _ . . ..

ALTERNATJV.L1 t'

Mainto;n current requirements in $35.32.

EIM

1. No additional regulatory burden to licensees.

2. No additional NRC resources would be needed for modifications to licensing or inspection procedures.

3. $35.32(a) would continue to require licensee to establish and maintain a wntten quality management program (QMP) to provide confidence that byproduct material or radiation therefrom will be administered as directed by the authorized user.

4. $35.32(b) would continue to require that licensees audit their QMP's to deterrnine the effectiveness of their program and retain records of the audit.

5. $35.32(c) would continue the concept of " recordable event" to be used to identify precursor events.

6. $35.32(d) would continue to require licensees to retain each written directive and record each administered dose or dosage requiring a written directive.

CD.01

1. Does not reduce regulatory burden to licensees.

2. Does not make the regulation more performance based.

3. 635.32(e) would continue to require licensees to submit modifications of their QMP's to NRC, whicli continues regulatory burden.

4 $35.32(f) would continue to require licensees to submit their QMP's to the NRC, which continues regulatory burden.

5. Rule is inconsistent with Commission direction (SRM on DSI 7) to focus on those requirements that are essential for patient ufety e.g., confirming patient identity, requinng wntteri prescriptions, and verifying .iose.

2

1:

Current Rule Text Section 35.32 Quality management program.

(a) Each applicant or licensee under this part, as applicable, shall establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The quality management program must include written policies and procedures to meet the following specific objectives:

(1) That, prior to administration, a wntten directive ' is prepared for; (l) Any teletherapy radiation dose; (ii) Any gamma stereotactic radiosurgery radiation dose; (iii) Any brachytherapy radiation dose; (iv) Any administration of quantities greater than 30 microcuries of either sodium iodide 1125 or 1131; or (v) Any therapeutic administration of a radiopharmaceutical, other than sodium iodide 1 125 or 1131; (2) That, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the wntien directive; (3) That final plans of treatment and related calculations for brachytherapy, teletherapy, and gamma stereotactic radiosurgery are in accordance with the respective written directives; (4) That each administration is in accordance with the wntten directive; and (5) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

(b) The licensee shall:

(1) Develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of:

(1) A representative sample of patient and human research subject administrations, (ii) M recordable events, and (iii) All misadministrations to verify compliance with all aspects of the quality management program; these reviews shall be j conducted at intervals no greater than 12 months; (2) Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the objectives of paragraph (a) of this section; and (3) Retain records of each review, including the evaluations and findings of the review, in an auditable form for three years.

(c) The licensee shall evaluate and respond, within 30 days after discovery of the recordable event, to each recordable event by:

(1) Assembling the relevant facts including the cause; (2) Identifying wnat, if any, corrective action is required to prevent recurrence; and (3) Retaining a record, in an auditable form, for three years, of the relevant facts and whht corrective action, if any, was taken.

3

(d) The licensee shall retain:

(1) Each wntten directive; and (2) A record of each administered radiation dose or radiopharmaceutical dosage where a wntten directive is required in paragraph (a)(1) above, in an auditable form, for three years

, after the date of administration.

(e) The licensee may make modifications to the quality management program to

, increase the program's efficiency provided the program's ef4ctivaness is not decreased. The licensee shall furnish the modification to the approprim NRC Regional Office within 30 days after the modification has been made.

(f)(1) Each applicant for a new license, as applicable, shall submit to the appropriate NRC Regional Office in accordance with 10 CFR 30.6 a quality management program as part of the application for a license and implement the program upon issuance of the license by the

! NRC.

(2) Each existing licensee, as applicable, shall submit to the appropriate NRC Regional Office in accordance with 10 CFR 30.6 by January 27,1992 a written certification that the quality management program has been implemented along with a copy of the program.

' If, because of the patient's condition, a delay in order to provide a written revision to an existing wntten directive would jeopardize the patient's health, an oral revision to cn Usting written directive will be acceptable, provided that the oral revision is documenud immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.

Also, a written revision to an existing wntten directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dore, the gamma sterectactic radicsurgery dose, the teletherapy dose, or the next teletherapy fractional dose.

If, because of the emergent nature of the patient's condition, a delay in order to provbe a wntien directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the ,

patient's record and a written oirective is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.

[56 FR 34121, July 25,1991, as amended at 59 FR 61783, Dec. 2,1994) 4'

ALTERNATIVE 2 Only require a wntten qual ty management program.

ELQA

1. Reduces regulatory burden to licensees (no audits or records).

2. Makes the regulation performance based.

3. $35.32(a) would coni.nue to require licensee to establish and maintain a written quality management program (QMP) to provide confidence that byproduct material or radiation therefrom will be administered as directed by the authorized user.

4. $35.32(e) would be deleted, discontinuing the requirement for licensees to submit modifications of their QMPs to the NRC which would decrease regulatory burden.

5. 935.32(f) would be deleted, discontinuing of the requirement for licensees to submit their QMPs to the NRC which would decrease regulatory burden.

6. Dose based rule.

7. Requirements in draft rule language is consistent with Commission direction (SRM on DSI 7) to focus on those requirements that are essential for patient safety, e.g.,

confirming patient identity, requineg written prescriptions, and verifying done D

1. Additional NRC resources would be needed for modifications to licensing or inspection procedures.

2. May increase on site inspection time (no audits or records of recordable events are available for inspector review).

l 3. No requirement ($35.32(b)) for licensees to audit their QMPs to determine the j effectiveness of their program and retain records of the audit.

4. $35.32(c) would be deleted, discontinuing of the concept of " recordable event" which is used to identify precursor events.

5. - No requirement ($35.32(d)) for licensees to retain each written directive and record each ,

administered dose or dosage requiring a written direc'.;ve, thus these records would not l be available for inspection, g 6. Guidance would need to be developed to assist licensees in determining when a QMP/ written directive is necessary 5

(

~.- - - - .

e l

l

\

Dfaft Rule Text Section 35.32 Quality management program.

(a) Each applicant or licensee under this part, as applicable, shall establish and maintain a wntten quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The quality management program mus' include written policies and procedures to. meet the i following specific objectives. l (1) That, prior to administration, a wntten directive $ is prepared when the dose to any organ or tissue exceeds 50.em:

(2) That, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the wntten directive; '

(3)'.* hat each administration is in accordance with the written directive; and (4) That any unintended deviation from the writion directive is identified and evaluated, and appropriate action is taken.

' If, because of the pat ent's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.

Also, a wntten revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision hi dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose.

if, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a wntten directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.

i .

6

4 i

1 ALTERNATIVE 3 l

Require written quality management program, retain each written directive and a record of each dosage requiring a wntten directive, and perform audits.

EID.1

1. - Reduces regulatory burden to licensees.

2. .Makes the regulation more performance based.

-3. $35.32(a) would continue to require licensee to establish and maintain a written quality management prograrn (QMP) to provide confidence that byproduct material or radiation therefrom will be administered as directed by the authorized user.

4 Retain a requirement ($35.32(b)) for licensees to audit their QMP to determine the effectiveness of their program and retain records of the audit.

5. Retains requirements ($35.32(d)) for licensees to retdin each written directive and record of each administered dose or dosage requiring a written directive.

6. $35.32(e) would be deleted, discontinuing the requirement for licensees to submit modifications oltheir QMP to the NRC.

7. $35.32(f) would be deleted, discontinuing of the requirement for licensees to submit their QMP's to the NRC.

8, Requirements in draft rule language is consistent with Commission direction (SRM on

-- DSI 7) to focus on those requirements that are essential for patient safety, e.g.,- _

confirming patient identity, requiring written prescriptions, and verifying dose, with the exception of the requirement for an audit.

C9M

1. Additional NRC resources would be needed for modifications to licensing and inspection-procedures.

2. $35.32(c) would be deleted, discontinuing of the concept of " recordable event" to be used to identify precursor event.

3. Guidance would need to be developed to assist licensees in determining when a QMP/ written directive is necessary 7

a Draft Rule Text Section 35.32 Quality nianagement program.

(a) Each applicant or licensee under this part, as applicable, shall establish and maintain a written quality management program to provide high confidence tht the byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The quality management program must include written policies and procedures to meet the following specific objectives:

(1) That, prior to administration, a wntt6n directive ' is prepared when the dose to any organ or tissue exceeds 50 rem:

(2) That, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive; (3) That each administration is in accordance with the written directive; and l

(4) That any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

(b) The licensee shall:

(1) Develop procedures for and conduct a review of the quality management program at intervals no greater than 12 months.;

and (2) Retain records of each review, including the evaluations and findings of the review, in an auditable form for three years, (c) The licensee shall retain:

(1) Each wntten airective; and (2) A record of each administered radiation dose or radiopharmaceutical dosage where a wntten directive is required in paragraph (a)(1) above, in an auditable form, for three years after the date of administration.

' If, because of the patient's condition, a delay in order to provide a written revision to an existing wntten directive would jeopardize the patient's health, an oral revision to an existing wntten directive will be acceptable, provi63d that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.

Also, a wntten revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dost.,, the gamma stereotactic radiosurgery dose, the teletherar y dose, or the next teletherapy fractional dose.

If, because of the emergent nature o the patient's condition, a delay in order to provide a written directive would jeopardize the pativnt's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.

8 ,

ALTERNATIVE 4 Require written quality management program, retain each written directive and a record of each dosage requiring a written directive, and maintain a record of recordable events.

i Etc.a

1. Reduces regulatory burden to licensees (I o required audit l 2. Makes the regulation more performance based.

1-

3. $35.32(a) would continue to require licensee to establish and maintain a written quality

- management program (QMP) to provide confidence that byproduct material or radiation l therefam will be administered as directed by the authorized user.

1

4. $35.32(c) would continue the concept of " recordable event" to be used to identify l precursor events.

5. Retains requirements ($35.32(d)) for licensees to retain each written directive and records of each administered dose or dosage requiring a written directive.

6. $35.32(e) would be deleted, discontinuing the requirement for licensees to submit modifications of their QMP to the NRC.

7. 635.32(f) would be deleted, discontinuing of the requirement for licensees to submit their QMP's to the NRC.

8. Requirements in draft rule language is consistent with Commission direction (SRM on DSI 7) to focus on those requirements that are essential for patient safety, e.g.. .

confirming patient identity, requiring written prescriptions, and verifying dose.

Conn -

1. Additional NRC resources would be needed for modifications to licansing and inspection '

procedures.

2. May increase on site inspection time.

3. $35.32(b) would be deleted, thus there would be no requirements for licensees to audit their QMP to determine the effectiveness of their program and retain records of the audit.

4. Guidance would need to be developeri to assist licensees in determining when a QMP/ written directive is necessary.

9

~

L.,

.w Draft Rule Text Section 35.32 Quality management program.

(a) Each applicant or licensee under this part, as applicable, shall establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user The quality management program must include written policies and procedures to meet the following specific objectives:

(1) That, prior to administration, a written directive ' is prepared when the dose to any organ or tissue exceeds 50 rem:

(2) That, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive; (3) That each administration is in accordance with the written directive; and l (4) That any unintended deviation from the written directive is identified and 6 valuated, f

.and appropriate action is taken.

(b) The licensee

• hall evaluate and respond, within 30 days after discovery of the recordable event, to each recordable event by:

(1) Assembling the relevant facts including the cause; (2; lderfifying what, if any, corrective action is required to prevent recurrence; and (3) Retaining a record, in an auditable form, for three years, of the relevant facts and what corrective action, if any, was taken.

m (c) The licensee shall retain:

(1) Each written directive; and

- (2) A record of each administered radiation dose or radiopharmaceutical dosage where a written directive k required in paragraph (a)(1) above, in an auditable form, for three years after the date of administration.

' If, because of the patient't. condition, a delay in order to provide a written revision to an existing wntten directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, prev;&c that the oral revision is documented immediately in the patient's record and ra revised wntien directive is signed by thd authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.

Also, a wntten revision to an existing written directive may be made for any diagnostic or therapeutic procedure providsd that the revision is dated and signed by an authorized user prior -

to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teleth cpy fractional dose.

If, because of the emergent nature of the pctient's condition, a delay in order to provide a written directive would jeopardize the patient's heahh, en oral directive will be acceptable, y l

provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive, 10

e QUALITY MANAGEMENT OVERVIEWS ALTERNATIVES KEY ITEMS FOR CONSIDERATION 1 2 3 4 Licensee establish and maintain QMP X X X X

[ objectives identified in regulation)

Licensee required to perform audits X X and record results Licensee required to retain written X X X directives and records of administered doses Licensee required to submit OMP X l

modifications to NRC Li:ensee required to maintain X X recordable events l

l l

l 11 1

__A

September 30,1997 THRESHOLD FOR REPORTABLE EVENT NOTE Following Commission approval of tr staffs program to revise 10 CFR Part 35 and associated guidance documents, the NRC staff . atiated 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 attematives to regulation in specific areas are intended to help focus the discussion during the NRC's public meetings and the meetings with nedical 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 attemative at this time, and is open to additional altematives which might be proposed that are consistent with the guidance provided by the Commission.

i m

ji.

yom s ' m%im u y _

9/29/97 PART 35 -THRESHOLD FOR REPORTABLE EVENT Summarv of Alternatives 1

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

" misadministration."

2. Threshold for reportable event is raised to the level of the NRC abnormal 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

" misadministration."

3. Threshold for reportable event is raised to the level of the NRC abnormal occurrence reporting cnteria, 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." (No requirement for recordable event.)

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 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.)

5. Thresholds for reportable event and recordable event, if applicable, would be set according to the outcome of discussions on Alternatives 1,2,3, and 4. Licensees would voluntanly report precursor events that are outside of the area currently defined by the term ' misadministration."

tLOTE 1 The term " misadministration' 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 precursor 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 resiitting from mechanical, structural or electrical malfunction of a system, as well as events resulting from procedural errors or human error. Examples of 1

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.

NOTE 3: Several of the afternatives presented in this document would base the reportable level on the NRC abnormal occurrence (AO) reporting criteria. The AO statement of pelicy contains criteria that are set at a level required to keep Congress and the public informed of unscheduled inadents or events which the Commission considers significant from the standpoint of 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 2

CURRENT DEFINITIONS / REQUIREMENTS Status Quo Recordable Status Quo Reportable (Recordable Event 635.2) (Misadministration 635.2)

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

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

Sodium iodide radio . Admin. dosage differs by $10% . Wrong patient.

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

Nal 125 or 1-131). . W/o written directive. . Admin. dosage differs by >20% .

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

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

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

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

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

prescr. dow;1e.

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

l- prescr. dose. . Wrong mode of treatment.

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

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

prescr. dose.

. Calculated total dose differs by

>20% total prescr. dose. 4

. If <3 fractions, calc. total done  !

differs by >10% total prescr.

dose.

Brachytharapy. . Calc. dose differs by >10% prescr. . Wrong patient.

dose. . Wrong radioisotope.

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

.W/o daily dose record. . Leaking source.

. Failure to remove source for a temporary implant.

. Calculated admin. dose differs by

>20% prescr. dose.

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

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

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

dose.

Abnormal occurrence event criteria - Misadministration (Management Directive 8.1):

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, of to the gonads, gI(2) equal to or greater than 10 Gy (1000 rad) to any other organ; AND

b. Represents either (1) a dose or dosage that is at least 50 percent greater than that presenbed in a written directive at (2) a prescrit ad dose or dosage that is (i) the wrong pharmaceutical, (ii) delivered by the wrong route of administra on. (iii) delivered to the wrong treatment site. (iv) delivered by the wrong treatment mode, or (v) from a leaking source (s).

3

e 4

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."

ELQS

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 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 Reorganization Act of 1974) to report abnormal occurrences (AOs) to Congress.

5. Licensees are familiar with current definition, therefore 4 would only be necessary to change current operating procedures to identify and report precursor events.

l CDDS l

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 resuk 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

4 Suaoested Rule Text Status Quo Recordable Status Quo Reportable

-(Recordable Event S35.2) (Misadministration $35.2)

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

pharmaceuticals (including < 30pC route. or dosage; and Nal.1-125 or 1 131). . Dose >5 rerr EDE or 50 rem to -

organ.

Sodium iodide radio . Admin. dosage differs by >10% . Wrong patient.

pharmaceuticals (where >30 pCi prescr. dosage and >15pCL , Wrong radiopharmaceutical.

Nal-125 or 1-131). . W/o wntien directNo. . Admin. dosage differs by >20%

. W/o daily dosage record. prescr. dosage and >30 pCL Therapeutic radio . Admin. dosage differs by >10% . Wrong patient.

l pharmaceutica!s. prescr. dosage . . Wrong mode of transport.

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

. W/o daily dosage record. . Adme n. 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% >

prescr. dose.

. Calculated total dose differs by

>20% total prescr dose.

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

dose.

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

dose. . Wrong racioisotope.

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

. W/o daily dose record. . Leaking source.

. Failure to remove source for a temporary implant.

. Calculated admin. dose differs by

>20% prescr. dose.

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

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

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

dose.

Additional requirement for reportable events:

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

5

ALTERNATIVE 2: Threshold for reportable event is raised to the level of the NRC abnormal 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

misadministration."

Ems

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 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 Reorganization Act of 1974) to report abnormal occurrences (AOs) to Congress.

5. Abnormal occurrence event reporting criteria are risk based.

C9BS

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

1 Suaoested Rule Text Recordable Event:

All diagnostic radio . Wrong pctient, radiopharm., route, or pham.aceuticals (including < 30pC dosage; and Nat,1-125 or 1131). . Dose >5 rem EDE or 50 rem to organ.

Sodium todide radio , Wrong patient.

pharmaceuticals (where >30 pCI . Wrong radiopharmaceutical.

Nal-125 or 1-131). . Administered dosage differs by >20%-

pre.cribed dosage and >30 pCl.

Therapeutic radio . Wrong patient.

pharmaceuticals. . Wrong mode of transport.

. Wrong route of admin.

. Administered dosage differs by >20%

presenbod dosage.

Teletherapy. . Wrong patient.

. . Wrong mode of treatment.

[ . Wrong treatment site.

l . Calculated weekly dose 30% > prescribed dose.

.Ce 'tated total dose differs by >20% total prose.nbod dose.

, if <3 fractions, calculated total dose differs by

>10% total presenbed dose.'

Brachytherapy. , Wrong patient.

b . Wrong radioisotope.

. Wrong treatment site.

. Leaking source.

. Failure to remove source for a temporary implant.

. Calculated administered dose differs by -

>20% prescribed dose.

Gamma stereotactic radiosurgery, . Wrong patient.

. Wrong treatment site.

. Calculated total administered dose differs by >10% total presenbed dose. __

Reportable Event;

a. Results in a dos 6 that is (1) equal to or greater than 1 gray (Gy) (100 rad) to a major pertion of the bone marrow, to the lens of the eye, or to the gonads, gt (2) equal to or greater than 10 Gy (1000 rad) 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 I 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).

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

7 m ~

ALTERNATIVE 3: 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 defined by the term

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

P.Los

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.

2. 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).

3. - Enables NRC to fulfill its 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.

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

C.Qat

1. Requirement may be considered as intruding into the area of patient confidentiality if the patient's name or identification is includert 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 voluma of reports, requiring a significant expenditure of NRC recources 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.

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.

8

Succested Rule Text:

- Reportable Event:

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, QI(2) equal to or greater than 10 Gy (1000 rad) 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 wntten directive gi (2) a prescr. bed dose or dosage that (l) is the wrong pharmaceutical, or (ii) is delivered by the wrong route of administration, or (iii) is delivered 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 ).

9

ALTERNATIVE 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 currently not covered by the current

• recordable event" definition. In addition, the definition for reportable event willinclude a statement to address precursor events. (No r3quirement for recordable event.)

ELOS

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.

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

CQD1

1. Requirement may be considere,d 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 with the potential for exposure and may result in an undue l 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 nave to change current operating procedures to identify and report precursor events.

10

Sugaested Rule Text Reportable Event:

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

(including < 30pC Nal,1-125 or 1-131).

Sodium iodide radiopharm (where . Wrong patient.

>30 pCl Nal.125 or 1-131. . Wrong radiopharmaceutical.

. Admin dosage differs by >10% prescr. dosage and $15pCl.

. W/o written directive.

. W/o daily dosage record.

Therapeutic radioparm. . Wrong patient.

. Wrong mode of transport.'

. Wrong route of administration.

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

. W/o written directive.

.W/o daily dosage record.

4 Teletherapy. . Wrong patient.

. Wrong mode of treatment.

. Wrong treatment site.

. Calculated total dose differs by $20% total prescribed dose.

. If <3 fractions, calculated total dose differs by >10% total presenbed dose.

l . Calculated weekly dose 15% > prescribed dose.

. W/c written directive.

. W/o daily dose record.

Brachytherapy. . Wrong patient.

. Wrong radioisotope.

. Wrong treatment site.

. Leaking source.

. Failure to remove source for a temporary implant.

. Calc. dose differs by >10% prescribed dose,

. W/o written directive.

. W/o daily dose record.

Gamma stereotactic radiosurgery. . Wrong patient.

. Wrong treatment site.

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

. W/o written directive.

. W/o daily dose record.

Additional requirement for reportable events:

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

11

4 4

ALTERNATIVE 5: Thresholds for reportable event and recordable event, if applicable, would be set according to the outcome of discussions on Alternatives 1,2,3, and 4.- Licensees would voluntarily report precursor events that are outside of the area currently defined by the term

" misadministration."

ECQA

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

2. - Voluntary reporting system may permit NRC to capture precursor events reported to other agencies or organizations and thus reduce duplicative reporting by licensees.

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

CADA

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.

Suaaested 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 EVENT i

Key items for Consideration Alt. Alt. Alt. Alt.

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 identify 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 can reveal a generic problem when compared nationally).

Enables NRC to fulfill its 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 prescriptive.

l .. -

l Requirement may oe considered as intruding into the area of x x x x l patient confidentiality if the patient's name or identification is l 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 Alternative 5 because the exact pros & cons will depend on which Alternative is used with the voluntary reporting of precursor events.

13

4 September 30,1997 PATIENT NOTIFICATION OF REPORTABLE EVENT NOTE 1

- 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 alternatives, with draft tule text, for the more significant issues associated with the regulation of the medical use of byproduct material. These alternatives 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 p: ased 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 alternatives which might be proposed that are consistent with the guidance provided by the Commission.

1i Ol0090%lLM

4 9/30/97 PART 35. PATIENT NOTIFICATION OF REPORTABLE EVENT Summarv of Alternatives

1. Status Quo: Licensee to notify NRC, referring physician, and patient or responsible i relative, unless referring physician personally informs the licensee that he or she will Infor.n the patient or that, based on medical judgment, telling the patient or a responsible relative would be harmful.

2. - Licensee to notify NRC only, but not referring physician or patient.

3. Licensee to notify NRC and referring physician, but not patient.

4. Licensee to always notify NRC, referring physician, and patient or guardian.

5. Licensee to notify NRC and referring physician, but not patient or guardian (or responsible relative) unless based on medical judgment there would be detrimental effects on patient due to the reportable event.

NOTE. Item 4 of the SRM, March 20,1997, states:

(Staff should consider...)

Changing the nomenclature from " misadministration" to

• medical event" or comparable terminology.

Use of term " guardian"in Attemative 4 & 5 is intended to encompass guardian, individual having " medical power of attorney" or "next-of-kin" but not all individuals who have been considered to be " responsible relative."

1

. . .l

a ALTERNATIVE 1: Status Quo: Licensee to notify NRC, referring physician, and patient or responsible relative, unless referring physician personally informs the licensee that he or she will inform the patient or that, based on medical judgment, telling the patient or a responsible relative would be harmful.

Pma -

1. Is consistent with other NRC requirements (e.g.,10 CFR $$ 19.13(d) and 20.2205) requiring licensees to provide reports to individuals receiving radiation exposure when licensees are required to report such exposure to NRC.

2, is consistent with other Federal legislation (e.g., Privacy Act) recognizing the right of individuals to know information about themselves which is contained in records both inside and outside the Federal sector See Statements of Consideration for misadministration rule at 45 Fed. Reg. 31701 (35-SC-10) and 55 Fed. Reg.1439, at 1444 (January 16,1990) p

3. Enables patients, in consultation with their personal physicians, to make timely decisions regarding remedial and prospective medical care. _56 Fed. Reg. 23360.

4. Enables NRC to identify the causes of misadministrations 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) add preserves patients right to know.

5. Enables NRC to fulfill its statutory obligation (in Section 208 uf The Energy Reorganization Act of 1974) to report Abnormal Occurrences (AOs) to Congress.

6. . ls consistent with present NRC guidance regarding medical events (e.g., Management Directive 8.10 Handbook regarding medical event reporting).

1. Current rule language lacks definition of " responsible relative," which may not be well '

understood by the medical community. Also, there appears to be multiple and -

sometimes conflicting interpretations of the extent to which and circumstances in which the " responsible relative" must be notified.

- 2. Patient notification requirement could be viewed as an unnecessary intrusion into the '

practice of medicine.

2

Current Rule Text (a) For a misadministration:

(1) The licensee shall notify by telephone the NRC Operations Center' no later than the next calendar day after discovery of the misadministration.

(2) The licensee shall submit a wntten report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the misadminisi,? tion. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual who received the misadministration;.

what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the individual (or the individual's responsible relative or guardian),

and if not, why not; and if there was notification, what information was provided. The report must not contain the individual's name or any other information that could lead to identification of the individual. To meet the requirements of this section, the notification of the individual receiving the misadministration may be made instead to that individual's responsible relative or guardian, when appropriate.

(3) The licensee shall notify the referring physician and also notify the individual receiving the misadministration of the misadministration no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, unless the referrir.g physician personally informs the licensee either that he will inform the individual or that, based on medical judgement, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring l physician, if the referring physician or the individual receiving the misadministration cannot be I

reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the individual as soon as possible thereafter.

The licensee may not delay any appropriate medical care for the individual, including any necessary remedial c,are as a result of the misadministration, because of any delay in notification.

(4) If the individual was notified, the licensee shall also furnish, within 15 days after discovery of the misadministration, a written report to the individual by sending either:

(i) A copy of the report that was submitted to the NRC; or (ii) A brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.

(b) Each licensee shall retain a record of each misadministration for 5 years. The record must contain the names of allindividuals involved (including the prescribing physician, allied health personnel, the individual who received the misadministration, and that individuars referring physician, if applicable), the individual's social security number or other identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence.

' The commercial telephone number of the NRC Operations Center is (301) 816-5100.

3 1

---_J

(c) Aside from the notification requirement, nothing in this section affects any rights or

. duties of licensees and physicians in relation to each other, to individuals receiving misadministrations, or to that individual's responsible relatives or guardians.

b

'g.

4

-l

~

4

ALTERNATIVE 2: Licensee to notify NRC only but not referring physician or patient.

PLQS

1. Would not directly result in what some view as NRC intrusion into the practice of medicine.

2. Enables NRC to identify the causes of reportable 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).

3. Continues to enable NRC to fulfill statutory obligation to report AOs to Congress.

4. Relies on ethical standard of care to present medical facts to patients. (SRM DSI-7)

5. May support more consistent compliance with the rule.

C.QDa

1. Is not consistent with other NRC requirements in Parts 19 and 20 regarding reporting radiation exposures to individuals when such reports are made to NRC. -

2. NRC and licensee potentially aware of patient information (e.g., potential consequences to patient health) when referring physician and patient are not aware for future informed decisions and medical histories by other physicians.

3. Does not effectuate specific Commission determination that patients have a right to know when they have been involved in a misadministration. 55 Fed. Reg.1444 (January 16,1990).

4. Recognizes inconsistent application of ethical standard of care.

5. If patients are not notified and need follow-up care, NRC may have, at minimum, an ethical obligation to either notify patients itself or find another entity (such as a state) to do so.

6. In order for NRC to comply with Section 208 of Energy Reorganization Act requirement to include " nature and probable consequences" in AO reports, NRC's action to obtain such information may inject NRC into patient-physician relationship and result in patient notification without explicit notification requirement in regulations.

5

4 Draft Rule Text

- (a) For a reportable event:

(1)The licensee shall notify by telephone the NRC Operations Center8 no later than -

the next calendar day after discovery of the reportable event.

. (2) The licensee shall submit a written report to the appropriate NRC Regional Office'-

- listed in 10 CFR 30.6 within 15 days after discovery of the reportable event. The written report must include the licensee's name; the prescribing physician's name; a brief description of.the event; why the event occurred; the effect on the individual; what improvements are needed to prevent recurrence; actions taken to prevent recurrence. The report must not contain the individual's name or any other information that could lead to identification of the individual.

_(b) Each . licensee shall retain a record of each reportable event for 5 years. The record must contain the names of all individuals involved (including the prescribing physician, allied health personnel, the individual, and that individual's referring physician, if applicable), the individual's social security number or other identification number if one has been assigned,- a brief description of the reportable event, why it occurred,- the effect on the individual, -

improvements needed to prevent recurrence, and the actions taken to prevent recurrence.

(c) Aside from the notification requirement, nothing in this section affects any. rights or.

- duties of licensees and physicians in relation to each other, to individuals involved in the reportable event, or to that individual's responsible relatives or guardians.

' The commercial telephone number of the NRC Operations Center is (301) 816-5100 6

ALTERNATIVE 3: Licensee to notify NRC and referring physician.

Pton

1. Does not involve NRC in what some view as intrusion into the practice of medicine.

2. Enables NRC to identify the causes of reportable 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) and preserves patient's right to know.

3. Continues to enable NRC to fulfill statutory obligation to report AOs to Congress.

4, Less prescriptive than current rule by relying on ethical standard of care to present ,

medical facts to patients. i

5. May support more consistent compliance with the rule.

6. Relies on ethical standard of care to present medical facts to patients. (SRM DSI-7)

CQat

1. Is not consistent with other NRC requirements in Parts 19 and 20 regarding reporting radiation exposures to individuals when such reports are made to NRC.

2. - Unless referring physician follows ethical standard to inform patients of medical facts, does not effectuate specific Commission determination that patients have a right to know when they have been involved in a misadministration. 55 Fed. Reg.1444 (January 16,1990).

3. NRC actions to obtain information to comply with Section 208 of Energy Reorganization Act of 1974, requirement to include " nature and probable consequences" in AO reports, could result in patient notification without explicit notification requirement in regulations.

4. Recognizes inconsistent application of ethical standard of care.

5. If patients are not notified and need follow-up care, NRC may have, at minimum, an ethical obligation to either notify patients itself or find another entity (such as a state) to do so, s

7 l

9 Draft Rule Text (a) For a reportable eve at:

(1) The licensee shall notify by telephone the NRC Operations Center8 no later than the next calendar day after discovery of the reportable event.

(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the reportable event. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the individual; what improvements are needed to prevent recurrence; actions taken to prevent recurrence. The report must not contain the individual's name or any other information that could lead to identification of the individual.

(3) The licensee shall notify the referring physician of the reportable event no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, if the referring physician cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the referring physician as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, Mcluding any necessary remedial care as a result of the reportable event, because of any delay in notification.

(4) If the referring physician was notified, the licensee shall also fumish, within 15 days after discovery of the reportable event, a written report to the referring physician by sending either:

(i) A copy of the report that was submitted to the NRC; or

(ii) A brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.

(b) Each licensee shall retain a record of each reportable event for 5 years. The record must contain the names of allindividuals involved (including the prescribing physician, allied health personnel, the individual, and that individual's referring physician, if applicable), the-individual's social security number or other identification number if one has been assigned, a brief description of the reportable event, why it occurred, thc effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence.

(c) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and hysicians in relation to each other, to individuals involved in the reportable event, or to that individual's responsible relatives or guardians.

The commercial telephone number of the NRC Operations Center is (301) 816-5100.

8

(

I

_ _ _ _ _ _ _ J

A ALTERNATIVE 4: Same as status quo but licensee must always notify patient or guardian -

0 f(does not provide for licensee reliance on referring physician to do so, or no notification based on medicaljudgment).

~P.Los

1. f is consistent with other NRC requirements (e.g.,' 10 CFR $$ 19.13(d) and 20.2205) requiring licensees to provide reports to individuals receiving radiation exposure when licensees are required to report such exposure to NRC.

2. Is consistent with other Federal legislation (e.g., Privacy Act) recognizing the right of individuals to know information about themse!ves which is contained in records both :

inside and outside the Federal sector. See Statements of Consideration for j misadministration rule at 45 Fed. Reg. 31701 (35-SC-10) and 55 Fed. Reg.1439, at 1444 (January 16,1990).-

-3/ Enables patients or guardian in consultation with their personal physician, to make -

timely decisions regarding remedial and prospective medical care. 56 Fed. Reg. 23360.

4. Enables NRC to identify the causes_ of reportable event 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) .

5. Enables NRC to fulfill its statutory obligation (in Section 208 of The Energy -

Reorganization Act of 1974) to report Abnormal Occurrences (AOs) to Congress.-

6; Patient or guardian would always be required to be notified because there is no provision for referring physician to inform patient in lieu of licensee doing so or for withholding notification based on medical judgment of harm to patient.

1 D 1

1. -- ' Determining who is " guardian" may be difficult without a definition, g

' 2. Not consistent with " therapeutic privilege

• of physician to withhold certain information .

from the patient which could adversely affect the patient's condition.

- 3. - Not consistent with Medical Policy Statement to minimize intrusion into the practice of medicine.

e

4. May not require notification of individual (responsible relative) who under current rule would have been notified.

4

( 9 L

Draft Rule Text (a) For a reportable event:

(1) The licensee shall notify by telephone the NRC Operations Centerd no later than the ncxt calendar day after discovery of the reportable event.

(2) The licensee shall submit a written report to the appropriate NRC Regional Office listed in 10 CFR 30.6 within 15 days after discovery of the reportable event. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the indivdual; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the individual (or guardian), and if not, why not; and if there was notification, what information was provided. The report must not contain the individual's name or any other information that could lead to identification of the individual. To meet the requirements of this section, the notification -

of the individual may be made instaad to that individual's guardian, when appropriate.

(3) The licensee shall notify the referring physician and also notify the individual (or guardian) of the reportable event no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery. If the referring l

physician or the individual cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the reportable event, because of any delay in notification.

(4) The licensee shall fumish, within 15 days after discovery of the reportable event, a written report to the individual by sending either:

(i) A copy of the report that was submitted to the NRC; or (ii) A brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.

(b) Each licensee shall retain a record of each reportable event for 5 years. The record must contain the names of allindividuals involved (including the prescribing physician, allied health personnel, the individual, and that individual's referring physician, if applicable), the individual's social security number or other identification number if one has been assigned, a brief description of the reportable event, why it occurred, the effect on the individual, improvements needed to prevent recurrence, and the actions taken to prevent recurrence.

(c) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals involved in the reportable event , or to that individual's guardian.

• The commercial telephone number of the NRC Operations Center is (301) 816-5100.

10

_____--_J

ALTERNATIVE 5: Licensee to notify NRC and referring physician, but not patient or guardian (or responsible relative) unless, based on meo; cal judgement, there would be detrimental effects on patient due to the reportable event.

Eto:i

1. Enables NRC to identify the causes of reportable 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) .

2. Continues to enable NRC to fulfill statutory obligation to report AOs to Congress.

3. Is consistent with Medical Policy statement to minimize intrusion into the practice of medicine, ,

4. Is consistent with SRM direction to revise Part 35 to be risk-based.

5. Is consistent with SRM direction to rely on industry standard [here, ethical standard of care), except for required notification of reportable events causing " detrimental' effects.

i CQRS l

1. Not consistent with Parts 19 and 20 regarding reporting to individuals radiation cxposure information fumished to NRC, which do not require threshold of " detrimental

• effects.

2. Determining what is " detrimental" may be difficult without definition of this term (e.g.,

some effects may be delayed in time).

3. NRC has previously rejected threshold of " clinically detectable adverse effect" (for reporting misadministrations) as not well understood by the medical community and a

" moving target" for patient notification of misadministration. 45 Fed. Reg. 31701.

4. NRC and referring physician may possess information regarding patient's medical treatment and consequences of misadministration without patient being aware of that information, which is not consistent with patient's 'right to know" (55 Fed. Reg.1444, January 16,1990).

5. Recognizes inconsistent application of ethical standard of care for reportable events not having detrimental effects.

6. May not require notification of all patient's (or guardians) who under current rule would have been notified.

7. Determining who is " guardian' may be difficult without a definition.

I1

__ .. _ _ _ . . ~ _ _

s Draft Rule Text (a) For a reportable event *

(1) The licensee shall notify by telephone the NRC Operations Center5 no later than the next calendar day after discovery of the reportable event.

(2) The licensee shall submit a written report to the appropriate NRC Regional Office j listed in 10 CFR 30.6 within 15 days after discovery of the reportable event. The wntten report '

must include the licencee's name; the prescnbing physician's name; a brief description of the event; why the event occurred; the effect on the individual; who improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the individual (or guardian), and if not, why not; and if there was notification, what information was provided. The report must not contain the individual's name or any other information that could i lead to identification of the individual. To meet the requirements of this section, the notification of the individual may be made instead to that individual's guardian, when appropriate.

(3) The licensee sha:l notify the referring physician and also notify the individual (or guardian) of the reportable event no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 2"ter its discovery if, based on medical judgment, there are or would be detrimental effects on the individual due to the reportable event. The licensee is not required to notif/the individual without first consulting the referring physician, if the referring physician or the individual (s) cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the reportable event, because of any delay in notification. ,

(4) If the individual was notified, the licensee shall also furnish, within 15 days after discovery of the reportable event,8: written report to the individual by sending either; (i) A copy of the report that was submitted to the NRC; or (ii) A brief description of both the event and the consequences as they may affect the individual, provided a statement is included that the report submitted to the NRC can be obtained from the licensee.

(b) Each licensee shall retain a record of each reportable event for 5 years. The record must contain the names of allindividuals involved (including the prescribing physician, allied health personnel, the individual, and that individual's referring physician, if applicable), the individual's sccial security number or other identification number if one has been assigned, a brief description of the, why it occurred, the effect on the individual, improwments needed to prevent recurrence, and the actions taken to prevent recurrence.

(c) Aside from the notification rcquirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals involved in the reportable event, or to that individual's guardian.

5 The commercial telephone number of the NRC Operations Center is (301) 816 5100.

12

l? PATIENT NOTIFICATION OVERVIEW

,' Al.TERNATIVES l

l- KEY ITEMS FOR CONSIDERATION 1 2 3 4 5 Consistent with other NRC requiremente (e.g.,10 CFR $$

l 19.13(d) and 20.2205) requiring licensees to provide reports to individuals receiving radiation exposure when licensees are X X required to report such exposure to NRC.

Consistent with other Federallegislation (e g., Privacy Act) recognizing the right of individuals to know information about themselves which is contained in records both inside X X and outside the Federal sector. See Statements of Consideration for misadministration rule at 45 Fed. Reg. I 31701 (35-SC 10) and 55 Fed. Reg.1439, at 1444 (1/16/90). ,

Rule clearly defines who must be informed. X X X Requirement minimizes intrusion into medical judgements X X X X affecting patients.

Notification requirement enables patients, in consultation with their personal physicians, to make timely decisions regarding X X X remedial and prospective medical care. 56 Fed. Reg. 23360.

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

Enables NRC to fulfill its statutory obligation (in Section 208 of X X X X X The Energy Reorganization Act of 1974) to report Abnormal Occurrences (AOs) to Congress.

Consistent with present NRC guidance regarding medical events (e.g., Management Directive 8.10 Handbook regarding X medical event reporting).

Relies solely on physician ethical standard of care to present X medical facts to patients. X Consistent with Commission SRM directive to rely on X X voluntary standards if such meets NRC needs.

Requires definition of " detrimental" effects. X Allows physician discretion, based on .nedical judgerrent, in X X X X deciding whether to inform patient of medical event.

Preserves patient right to know. X X Requires defin) tion of ' guardian

• or " responsible relative' X X X 13

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