ML20141A345

Informs That Listed Rules Have Been Compatable W/Nrc Requirements.Rule 1200-2-5-.75, Quality Mgt Program for Human Use, Did Not Get Reviewed

ML20141A345
Person / Time
Issue date:	04/25/1997
From:	Bangart R NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Scharber W TENNESSEE, STATE OF
References
NUDOCS 9705140237
Download: ML20141A345 (8)

Text

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April 25, 1997 a

Mr. Wayne K. Scharber Deputy Commissioner Tennessee Department of Environment and Conservation L&C Tower,21st Floor 401 Church Street Nashville, TN 37243-1532

Dear Mr. Scharber:

In December 1996, during the Tennessee review, the Integrated Materials Performance Evaluation Program (IMPEP) team found five rules that NRC had not reviewed for compatibility. While some differences exist in the Tennessee regulations that were reviewed, we have reviewed the following rules and find them to be compatible with NRC's requirements.

e Rule 1200-2-11.03: "Licensino Reauirements for Land Disposal of Radioactive Waste," Paraaraoh (15) and Definition of Land Disoosal Facilitv. This rule is equivalent to NRC's " Definition of Land Disposal and Waste Site QA Program,"

10 CFR Part 61198 FR 39628) thct became effective on July 22,1993.

e Rule 1200-2-5.14: " Notification of incidents" Paraaraohs (1) and (2). TN made changes to this regulation to conform with NRC's requirement. This rule is equivalent to NRC's " Notification of incidents," 10 CFR Parts 20,30,31,34,39, 40,70 amendments (56 FR 64980) which became effective on October 15,1991.

o Rule 12-2-8: " Radiation Safety Reauirements for Industrial Radioaraohv Operations."

TN amended Section 1200-8.03 to include definitions for radiographer, i

radiographer's assistant, radiographic exposure device, source changer, storage area, and storage container. These definitions are equivalent to those found at 10 CFR Part 34.2.

Rule 12-2-8; " Radiation' Safety Reauirements for Industrial Radioaraohv Ooerations "

o TN amended Section 1200-8.04 "Eauioment Control," Paragraphs (1) (a) and (b) to include these requirements. These changes are equivalent to NRC's 10 CFR Part 34.21(a) and (b) amendments (55 FR 843) which became effective on January 10, 1991.

OSP did not review the following rule.

e Rule 1200-2-5.75: " Quality Manaaement Prooram for Human Use." TN has completed this rule. The Tennessee Department of Environment and Conservation had not approved it at the time of the IMPEP review. NRC has planned to significantly change NRC's present rule. The outcome of this activity remains uncertain. Therefore, OSP has not reviewed this rule, consistent with the position

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i Wayne K. Scharber APR 2 51997 Statements and Implementing Procedures for: ' Statement of Principles and Policy for the Agreement State Program' and ' Policy Statement on Adequacy and Compatibility of Agreement State Programs.'" We will conduct a review in acco' dance with compatibility guidance that will be developed for the revisicm, of j

Part 35.

.j If you have any questions, please contact me at 301 415-3340.

Sincerely, 1

At h

Richard L. Bangart, Directpr Office of State Programs

cc:

Kenneth W. Bunting, Director Division of Superfund Michael H. Mobley, Director Division of Radiological Health I

Lawrence E. Nanney, Deputy Director Division of Radiological Health l

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Wayna K. Scharb:r APR 2 51397

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Statements and Implementing Procedures for: ' Statement of Principles and Policy for the Agreement State Program' and ' Policy Statement on Adequacy and 1

Compatibility of Agreement State Programs.'" We will conduct a review in accordance with compatibility guidance that will be developed for the revisions of Part 35.

if you have any questions, please contact me at 301-415 3340.

4 Sincerely, Odginalsigned By 4

RICHARD L BANGART Richard L. Bangart, Director Office of State Programs cc:

Kenneth W. Bunting, Director i

Division of Superfund Michael H. Mobley, Director i

Division of Radiological Health Lawrence E. Nanney, Deputy Director Division of Radiological Health i

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Distribution:

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Tennessee File DOCUMENT NAME: G:\\JHM\\TNREGREV.JHM

• See Previous Concurrence, j

Ta recalve a copy of this document, ind6cate in the box:

'C' - Copy without ettschment/ enclosure

'E" = Copy with attachment /enclosge "N* = No copy

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OFFICE OSP l

OSP OSP:DD OGC OSP:[/(l[p

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NAME JHMyers:gd/nb KSchneider PHLohaus FXCameron RLBangbrt' U j

DATE 04/07/97*

04/07/97*

04/08/97*

04/22/97*

04)f/97 1

OSP FILE CODE:SP-AG-20 i

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W yp K., Sch rber 9 e

Statements and Implementing Procedure $ for: ' Statement of Principles and Policy for the Agreement State Program' and ' Policy Statement on Adequacy and i

Compatibility of Agreement State Programs.'" We will conduct a review in accordance with compatibility guidance that will be developed for the revisions of Part 35.

If you have any questions, please contact me at 301-415-3340.

Sincerely, Richard L. Bangart, Director Office of State Programs

/

- cc:

Kenneth W. Bunting, Administrator Land and Radiation Programs Michael H. Mobley, Director Division of Radiological Health Lawrence E. Nanney, Deputy Director Division of Radiological Health l

l 1

Distribution:

l DIR RF DCD (SP08)

SDroggitis PDR (YESf)

Tennessee File DOCUMENT NAME: G:\\JHM\\TNREGREV.JHM

• See Previous Concurrence N

'C' = Copy without attachrnent/ enclosure $'N % M tM.

l T: receive e copy of this document. Indicate in the bos:

E'.= Copy with ettschment/ enclosure

'N' = No copy OFFICE OSP l

OSP l

OSP:DD l 70GC l

OSP:D l NAME JHMyers:gd/nb KSchneider 1 PHLohaus FXCameron RLBangart DATE 04/07/97*

04/07/97*,

04/08/97*

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UNITED STATES g

NUCLEAR REGULATORY COMMISSION f

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ono, Mr. Wayne K. Scharber l-1 Deputy Commissioner Tennessee Department of Environment and Conservation ch'rb O L&C Tower, 21st Floor (6Lwa 401 Church Street

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Nashville, TN 37243-1532f-7 b#

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Dear Mr. Scharbe.:

In December 19d6, during the Tennessee review, the Integrated Materials Performance Evaluation Profram (IMPEP) team found five rules that NRC had not reviewed for compatibility.6We have reviewed the following rules and find them to be compatiole with NRC's requirements.

e Rule 1200-2-11.03: "Licensino Reauirements for Land Disoosal of Radioactive Waste." Paraaraoh (15) and Definition of Land Disposal Facilitv. This rule is equivalent to NRC's " Definition of Land Disposal and Waste Site QA Program,"

10 CFR Part 61 (58 FR 39628) that became effective on July 22,1993.

Rule 1200-2-5.14: " Notification of incidents" Paraaraohs (1) and (2). TN made changes to this regulation to conform with NRC's requirement. This rule is equivalent to NRC's " Notification of incidents," 10 CFR Parts 20,30,31,34,39, 40,70 amendments (56 FR 64980) which became effective on October 15,1991.

Rule 12-2-8: " Radiation Safety Reauirements for Industrial Radioaraohv Operations."

TN amended Section 1200-8.03 to include definitions for radiographer, radiographer's assistant, radiographic exposure device, source changer, storage area, and storage container. These definitions are equivalent to those found at 10 CFR Part 34.2.

Rule 12-2-8: " Radiation Safety Reauirements for Industrial Radioaraohv Operations."

TN amended Section 1200-8.04 "Eauioment Control." Paragraphs (1) (a) and (b) to include these requirements. These changes are equivalent to NRC's 10 CFR Part 34.21(a) and (b) amendments (55 FR 843) which became effective on January 10, 1991.

OSP did not review the following rule.

Rule 1200-2-5.75: " Quality Manacement Procram for Human Use." TN has completed this rule. The Tennessee Department of Environment and Conservation had not approved it at the time of the IMPEP review. NRC has planned to significantly change NRC's present rule. The outcome of this activity remains uncertain. Therefore, OSP has not reviewed this rule, consistent with the position described for the Commission in SECY-97-054, " Final Recommendations on Policy

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is completed and the State has had time to make changes, if required, to the i

uality Management Program.

3340 if you have any questions, please contact me at 301-415-332(

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Sincerely f'

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i Richard L'.'Bangart, Director Officeif State Programs

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cc:

Kenneth W. Bunting, Administrator

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Land and Radiation Programs

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Michael H. Mobley, Director

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Division of Radiological Health

/

Lawrence E. Nanney, Deputy Dir'ector Division of Radiological Health'

/

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Dis ribution:

DIR RF DCD (SP08)

SDroggitis PDR (YESf)

Tennessee File i

DOCUMENT NAME: G:\\JHM\\TNREGREV.JHM Ta receive e copy of this document, indicate in the boa: 'C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure

'N' = No copy OFFICE OSP g OSP g)

Opp OGC OSP:D l

NAME JHMyers:g5 KSchneider PH(6J!!B FXCameron RLBangart DATE 04r) /97 04r] /97 04/]/97 04/ /97 04/ /97 OSP FILE CODE:SP-AG-26

FAX INFORMATION U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF STATE PROGRAMS i

2 OFFICE OF STATF "- ' GRAMS FAX: (301) 415-3502 i

i NUMBER OF PAGES: 3 including this page DATE:

APRIL 28,1997 i

TO:

MICHAEL H. MOBLEY

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FROM:

RICHARD L. BANGART, DIRECTOR i

OFFICE OF STATE PROGRAMS i

(301) 415-3340 i

SUBJECT:

TENNESSEE REGULATIONS i

VERIFICATION - 415-3340 4

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04-28-1997(MON) 16:30 E

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DATE TIME DESTINATlON STATION PO.

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MEMORANDUM TO:

Francis X. Cameron, Special Counsel for Public Liaison and Agreement State Programs 4

Office of General Counsel FROM:

Richard L. Bangart, Director

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SUBJECT:

REVIEW OF TENNESSEE REGULATIONS FOR COMPATI ITY In December 1996, the Tennessee (TN) IMPEP team discovered five regulations had not been reviewed by NRC for compatibility. OSP has reviewed these regulations and have found them to be compatible with NRC requirements. We are submittireg them to you for a final compatibility determination.

OSP provides comments on the regulations in question below:

o Rule 1200 2-11.03: "Licensino Reauirements for Land Disposal of Radioactive Waste." Paraoraph (15) and Definition of Land Disposal Facility (Attachment 1).

The equivalent NRC requirement is found at 10 CFR Part 61.2 and is a Division 1 matter of compatibility. The TN definition is identical to NRC's.

e Rule 1200-2-5 14: " Notification of incidents." Paraaraohs (1) and (2)

(Attachment 2). TN made changes to this regulation to conform with NRC's requirement. NRC's equivalent rule is found at 10 CFR Part 20.2202, Notification of incidents. NRC requires immediate notification about certain incidents and the rule is a Division 2 matter of compatibility.

The paragraph (1) of the TN rule states that licensees "shall notify the Division as soon as possible but not later than four (4) hours after discovery...." Although they word this requirement differently, the intent of the TN requirement is the same or more restrictive than NRC's requirement.

The paragraph (2) of the TN rule does not contain some wording found in NRC's requirement. TN did not include the phrase " involving loss of control of licensed material" in their regulation. TN's regulations refer to a " source of radiation." This substitution makes the TN rule consistent with Suggested State Regulations that apply to non-AEA material and other radiation producing devices, e

Rule 12-2-8; " Radiation Safety Reauirements for Industrial Radioaraohv Operations" (Attachment 3). TN made several modifications to the regulations govern:ng radiography operations.

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3 Francis X. Cameron

-2 APR 1 o ggg7 TN amended Section 1200-8.03 Definitions to include definitions for radiographer, radiographer's assistant, radiographic exposure device, source changer, storage area, and storage container. The definitions are a matter of Division 1 compatibility are found in 10 CFR Part 34.2. The State's definitions gr4similar by NRC.

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TN also amended Section 1200-8.04 "Eauipment Control," Paragraphs (1) (a) and (b). These sections are Division 2 level of compatibility. The TN equivalent nde::

are identical to the requirements found in NRC's 10 CFR Part 34.21(a) and (b).

e Rule 1200-2-5.75: " Quality Manaaement Proaram for Human Use" (Attachment 4).

TN completed this rule but it was not approved by the Tennessee Department of Environment and Conservation. NRC has planned to significantly change NRC's present rule. The outcome of this activity remains uncertain. Therefore, OSP has not reviewed this rule, consistent with the position described for the Commission in SECY-97-054. We will conduct a review in accordance with compatibility guidance that will be developed for the revision of Part 35.

3 Also for your comment and concurrence is a letter we propose to send to the State of Tennessee reporting NRC's findings on their rules.

If you have questions about the regulation review or this correspondence please contact me or Jim Myers at 415 2328 or JHM.

Attachments:

As stated

l Page 1 of 8 Pages V

lno bwL Proposed Rules i

of j

Tennessee Department of Environment and Conservation Division of Radiological Health j

Chapter 1200-2-11 Licensing Requirements for Imd Disposal of Radioactive Waste Presented herein are proposed amendments of the Department of Environment and Conservation, submitted pursuant to T.C.A. Section 4-6-202 in lieu of a rulemaking hearing. It is the intent of the Department d Environment and Conservation to promulgate these amendments without a rulemaking hearing unless a petition requesting such hearing is filed within thirty (80) days of the publication date of the issue of the Tennessee Administrative Resister in which the proposed amendments are published. Such petition to be effective must be filed at the Division of Radiological Health, hird Floor of the L & C Annex Building located at 401 Church Street, Nashville, TN 87243-1532, and in the i

Department of State, Fifth Floor, James K. Polk State OfBee Building, Sixth and Deaderick, Nashville, TN 37243-0310, and must be signed by twenty-6ve (25) persons who will be affected by the rule, or submitted by a municipality which will be affected by the rule, or an association of twenty-five (25) or more members, or any standing committee of the General i

f Assembly.

e For a copy of this proposed rule contact: Barbara A. Davis, Division of Radiological Health, Third Floor, L & C Annex, 401 Church Street, Nashville, TN 37243-1532, and 615 532-0364.

De text of the proposed amendmenta is as follows:

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Amendments Paragraph (15) of Rule 1200-2-11.03 Definitions is amended by adding the word

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" structures, " and substituting the word "are" for 'is", so that as amended the paragraph

. fy shall read:

ty (15)

Imd disposal facility - Means the land,Ibuildingsl structures $ and equipment which

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are intended to be used for the &sposal of radioactive wastes. /

N Part 10 of Subparagraph (a) of Paragraph (

ley 2 P.08 Content of Application T

is amended by substituting the word "assuran for " control" by adding the words ",

developed and applied by the applicant,

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--us "for the determination of 4

natural &sposal site characteristics" and substituting the words "to the determination of the b

natural characteristics of the disposal site", and by deleting the words "for quality assurance l

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during", no that as amended the part shall read:

10.

A description of the quality assurance prograd, developed and applied by the 1

applicant to:

(i) The determination of the natural characteristics of the disposal site, (ii) ne design, construction, operation and closure of the land disposal facility, and (iii)The receipt, handling, and emplacement of waste.

Audits and managerial controls must be included.

Authority: T.C.A. l68-202-206 and 4-5-202.

1 ATTACHMENT 1

l[,

Page 2 of 8 Pag;s i1 Party who will approve final copy for 14

Contact:

publication and contact for disk acquisition:

Greer C. Tidwell, Jr.

Barbara A Davis TDEC OfBee of General Counsel TDEC Dmaion of Radiological Health 30th Floor. L & C Towet Srd Floor, L & C Annex 401 Church Street 401 Church Street Nashville, TN 87248-1548 Nashville, TN 87248-1582 (615) 583-4181 (615) 582-0864 Signature of the agency of5cer or ofncers directly responsible for proposing and/or draftmg these rules.

Michael H. Mobley, Director Barbara A. Davis Division of Radiological Health Division of RadiologicalHealth I certify that this is an accurate and complete copy of proposed rules lawfully promulgated and adopted by the Tennenee Department of Environment and Conservation on the day of 19 The Secretary of Stata is hereby instructed that,in the absence of a petition for rulemaking hearing being filed under the conditions set out herein and in the locations described, he is to treat thw proposed rules as being placed on file in his of5ce as rules at the expiration of thirty (80) days after the publication date of the issue of the Tennessee Administrative i

Register in which these proposed rules are published.

Justin P. Wilson, Commissioner Tennessee Department of Environment and Conservation Subscribed and sworn to before me this the day of 19 Notary Public My commission expires on the day of 19 All proposed rules provided for herein have been examined by the Attorney General and Reporter of the State of Tennessee and are approved as to legality pursuant to the provisions of the Administrative Procedures Act, Tennessee Code Annotated, Title 4, Chapter 5.

Charles W. Burson l

Attorney General and Reporter I

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

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Page 8 d3 Pages The proposed rules set out herein were properly filed in the Department d State on the day d 19

. and pursuant to the instructions set out above, and in the absence d the filing d an appropriate petition calling for a rulemaking headn;f, will become effective on the day d 19 i

l Riley C. Darnell

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Secretary MState t

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Page 1 of 5 Pag:s At3 sSU(,*

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Rulemaking Hearing Rules

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d Tennessee Department of Environment and Conservation 1

Division of Radioloswal Health CBapter 1200-2-6 Standards for Protection Against Radiation

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i Amendments Rule 1200-2-6.141 Notincation of Incidents is amended by deleting the Rule and substituting new wording, so that as amended Rule 1200-2-6.141 shall read:

I 1900-3-6.141 Notiscation ofIncidents (1)

Immediste noti 6 cation Notwithstan er requirements for nota $ cation the requirements of this Rule am controlhng. Licensees and registrants shall notify the Division as soon as possible but not later than four (4) hours after discovery that a source f radiation possessed by the licensee or egistrant has caused, may have j

caused or threatens to cause any of the folkming An individual to receive:/

3 (a)

/

T A total effective dose equivalent of 25 rems (0.25 Sv) or more, /

j 1.

2.

An eye dose equivalent of 75 rems (0.75 Sv) or more, or 3.

A shallow-dosyivalent to the skin or extremities of 250 rads (2.5 Gy) or more; (b) ne release of radioactive material that could cause an individual present for 24 houg to receive Sve times or more the annual occupational limit on intake. His does not apply to locations where personnel are not normally stationed dpg routine operations, such as hot-cells or specific process enclosures; or (c)

Prevention ofimmediate protactive actions necessary to avoid exposure to radiation or releases that could exceed regulatory limits (events may include fires, explosions, toxic gas releases, etc.).

(2)

Twenty--(our hour noti 6 cation. Licensees and registrants shall notify the Division within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery that a source af radiation possessed by the licensee

= reguirant may Fave causea o,r threatens to cause any of the followmg: /

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7 dwvMeI.

l. meas /p (a)

An individual to receive, in a period of 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />s:

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L 1.

A total effective dose equivalent exceedmg 5 rems (0.05 Sv),

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2.

An eye dose equivalent exceeding 15 rems (0.15 Sv), or 3.

A shallow-dosgeuivalent to the skin or extremities exceeding 50 rems (0.5 Sv);

ATTACHMENT 2

_ _ _. _... _ _ _ _ _ _. _ _ _. ~,

Page 2 of 5 Pages

,l-l (b)

De role of radioactive material that could cause an individual present for i

24 h to receive an intake exceedmg one annual occupational limit on intake.

' does not apply to locations where personnel are not normally i

stationed dyhng routine operations, Vouch as hot-cells #or speci6c process enclosures %, r l

(c)

Any of the following events involving licen le material:

1.

An unplanned contamination event that: -

(i)

Requires restricted access to the contaminated area for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Restriction may be by imposing additional l

radiological controls or by prohibiting entry into the area, i

(ii)

Involves a quantity of material greater than Sve times the lowest annual limit on intake specined for the material in i

2 Schedule RHS B-30 of 1200-2-5, and l

(iii)

Restricta access to the area for a reason other than to allow l

isotopes with a half-life ofless than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> to decay prior l

to decontamination.

2.

An event in which equipment is disabled or fails to function as designed when:

(i)

De equipment is required by regulation or license condition to:

1 3

1 i

(I)

Prevent releases exceeding regulatory limita, (II)

Prevent exposures to radiation exceedmg regulatory limita, or h

(III)

Mitigate the consequences of an accident; (ii) ne equipment is required to be available and operable when it is disabled or fails to function; and (iii)

No equipment meeting the same performance standards is immediately available, operable and capable of performing the required safety function.

l 8.

An event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body.

4.

An unplanned fire or explosion damaging any licensable material or any device, container or equipment containing licensable material when:

(i)

De quantity of material involved exceeds Sve times the lowest annual limit on intake specified for the material in Schedule RHS 8-30 of 1200-2-5, and

Page 3 of 5 Pages s.

l (ii)

De damage affects the integrity of the licensable material or any device, container or equipment containing licensable material.

l (8)

Preparation and submission of reports Licensees and registrants shall make i

reports in response to the requirements of this sectaan as follows:

(a)

Licensees and registrants shall make reports required by paragraphs (1) and j

(2) of this Rule by telephone to the Division.

i q

1.

De telephone number for the Dwision is:

(615) 582-0884 7:00 a.m. Central Time to 4:80 p.m. Central Time i

except weekends and holidays (615) 741-0001 Tennessee Emergency Management Agency at all l

other times.

l 2.

To the extent that the information is available at the time of notification, the information prwided in these reporta shall include:

i (i) ne caber's name and call back telephone number; i

j (ii)

A description of the event, including date and time; (iii)

The exact location of the event:

4 1

i l

(iv) ne isotopes, quantities, and chemical and physical form of s

the licensable material involved; and i

4 (v)

Any personnel radiation exposure data available.

4 i

(b)

Written report. Licensees and registrants who make a report required by i

paragraph (1) or (2) of this Rule shall submit a written follow-up report within 30 days of the initial report. His requirement may be antisfied by submitting written reports prepared under other regulations that contain all necessary information and are appropriately distributed. Licensees and registranta shall send these written reports to the Division at the address given in 1200-24.07. De reports shall include the foBowmg:

1 1.

A description of the event, including the probable cause and the manufacturer and model number (if applicable) of any equipment that failed or malfunctioned; 2.

De exact location of the event; 3.

De isotopes, quantities, and chemical and physical forms of the licensable materialinvolved; 4.

Date and time of the event; 5.

Corrective actions taken or planned and the results of any evaluations or assessments; and

i,-

Page 4 of 5 Pages 4

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i.-

6.

For each individual exposed.

(i) l De name, Social Security number and date of birth. De report i

shall be prepared so that this information is stated in a separate and detachable part, and (ii) j

%e extent of exposure of each individual without identification of individuals by name.

e

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(4) his Rule does not include doses that result from, and are within the limits for, planned special exposures reported under 13-S4.144.

Authority: T.C.A 4-6-201 ei seq.; T.C.A 68-202-203 and 206.

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1 Party who will approve final copy /

j 14 gal

Contact:

Contact for disk acquisition:

Greer C. Tidwell, Jr.

Barbara A Davis TDEC OfDee of General Counsel TDEC Division of Radiological Health

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20th Floor L & C Tower 3rd Floor, L & C Annex 2

401 Church Street 401 Church Street i

Nashville,TN 3724S-1548 Nashville, TN 37243-1532 (615) 532 4 131 (615) 532-0364 n

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Page 5 of 5 Pages J.

l Signature of the agency officer or afBeers directly responsible for proposing and/or drafting these rules:

l Michael H. Mobley, Director Barbara A. Davis Division of Radiological Health Division of Radiala-ieal Health i

I certify that this is an securate and complete copy of rulemaking hearing rules, lawfully promulgated and adopted by the Department of Environment and Conservation on the i

day of 19 1

i 4

Further, I certify that the prwisions of T.C.A. 544-222 have been fully complied with, that I

these rules are properly presented for Bling, a notice of rulemakmg hearing has been filed in the Department of State on the day of 19 and such notice of rulemaking hearing having been published in the 19

. issue of the Tennessee Administrosive Register, and such rulemaking hearing having been conducted pursuant thereto on the day of 19 Justin P. Wilson, Commissioner Tennessee Department of Environment and Conservation Subscribed and sworn to before me the day of 19 i

Notary Public My commission expires on the day of 19 All rulemaking hearing rules provided for herein have been examired by the Attorney General and Reporter of the State of Tennessee and are approved as to legality pursuant to the provisions of the Administrative Procedures Act, Tennessee Code Annotated, Title 4, Chapter 5.

Charles W. Burson Attorney General and Reporter De rulemaking hearing rules set out herein were properly filed in the Depa rtsoent of State on the day of 19 and will become ethtive on the day of 19 Riley C. Darnell Secretary of State By

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RULES 4,]h, OF

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DEPARTMENT OF ENVIRONMENT AND CONSERVATION 4

DIVISION OF RADIOLOGICAL HEALTH g,N

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CHAPTER 1206-3-8 RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHY OPERATIONS d

TABLE OF CONTENTS 2204-2-8.01 Purpose 1200-2-8.07 Muumum Subjects To &

1200-2-8.02 Scope Covered in Training 1200-2-8.03 Definitions Radiographers 1200-2-8.04 Equipment Control 1200-2-8.08 Cabinet Radiography 1200-2-8.05 Personal bdistion Safety 1200.-2-8.09 Fluoroscopic Radiography bquirements for 1200-2-8.10 bquimd Administrative Radiographers and Procedures for Industrial Radiographer's Assistants Radiography Program 1200-2-4.06 Precautionary Procedures in 1200-2-8.11 Shielded Room X-Ray Radiographie Operations Radiography 1200-2-8.12 kporting bquirements 1206-2-8.01 Purpose

'this Chapter establishes requirements for the use of sourecs of radiation for industrial radiography operations. Except for the requirements of this Chapter clearly applicable only to devices employing sealed radioactive sources, e.g., 1200-2-6.04(1) and (5), both radiation machines and sealed radioactive sources are covered by this Chapter. The provisions of this Chapter are in addition to and not in substitution for other applicable provisions of these regulations.

Authority:

T.C.A. l14-5-201 et seq., 68-202-203 and 68-202-206. Administrative History: Origino! rule certi6ed June 7,1974. Amendment (ded August is,1978; effective October 2,1978. Amendment Bled April 3,1986; effective May 31,1986. Repeal and new rule fled October 27,1993; effective January 10,1994.

1200-2-8.02 Scope The regulations in this Chapter apply to all licensees or registrants who use sources of radiation for industrial radiography. Nothing in this Chapter shall apply to the use of sources of radiation in the healing arta.

Authority:

T.C.A. ll4-5-201 et seq., 68-202-203 and 68-202-206. Administrative History: Original rule certifed June 7,1974. Amendment Bled August 15,1978; effective October 2,1978. Amendment Bled April 3,1986; effective May 31,1986. Repeal and new rule (ded October 27,1993; effective January 10,1994.

1200-2-8.03 Dennitions (1)

Cabinet radiography means industrial radiography using radiation machines in an enclosed interlocked cabinet in which:

ATTACHMENT 3 8-1

3 i.-

n (a) he radiation machine will not operate unless all openings are closed with

[

interlocks activated; i

i (b) ne cabinet is so shielded that every location on the exterior meets the conditions for an unrestricted area as defined in Chapter 1200-2-4; and 1

(c) ne cabinet is no constructed or arranged as to emelude the entrance of any

.l part of the body of an individual during irradiation.

i (d)

Baggage entrance and exit openings of airport baggage systems need not be 1

interlocked. All other openings in these systems shall be interlocked. De i

operator shall be present during operation to ensure no individual enters the

)

device through the baggage entrance or exit opening (s).

(2)

Direct Surveillance means direct physical observation of a source of radiation, i

source changer or storage container.

l (3)

Permanent radiographic inssallatian means a shielded installation or structure designed or intended for radiography and in which radiography is regularly performed.

l (4)

Personal supervision means supervision with the radiographer:

1 (a)

Physically present at the site where sources of radiation ;and associated equipment are being used; (b)

Observing the radiographer's assistant's pedormance; and (c)

In such proximity that immediate assistance can be given if required.

(5)

Radiographer means any individual who performs or personally supervises industrial radiographic operations and is responsible to the licensee or registrant for assuring compliance with these regulations and alllicense or registration conditions.

(6)

Radiographer's assistant means any in#vidual who, under the personal supervision of a radiographer, uses sources of rataation, related handling tools or radiation survey instrumenta in industrial radiogrGphy.

(7)

Radiogrqphic emosure device means:

(a)

Any instrument having a sealed source in which the sealed source or abielding thereof may be moved or otherwise changed from a shielded to unshielded position; or (b)

Any apparatus that may produce, when the associated controls are operated, one or more forms of radiation used for making a radiographic exposure.

(8)

Shielded room x-ray rodaagraphy means industrial radiography utilizing radiation machines that is conducted in an enclosed room-l (a)

Which is not occupied during radiographic operations; 8-2 j

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6)

Which is shielded so that every location on the exterior meets the conditions for an unrestncted area as de6ned in Chapter 1200-2-5; and (c) he only access to which is through openings that are interlocked so that the i

radiation machine will not operate un!-es all openings are closed with a

interlocks actwated.

W)

Source changer raeans a device designed and used for replacement of sealed sources in redirgraphie exposure devices, including those also used for transportation and storan of sealed sources.

(10)

Storage area means any location, facility or vehicle that is used to store, to transport or to secure a redsgraphic exposure device, a storage container, or a sealed source when it is not in use and that is locked or has a physical barrier to prevent accidental exposure, tampering with or unauthorised removal of the device, container or source.

I (11)

Storage container m.ans a device in which sealed sources are transported or stored.

l (12)

Temporaryjob site means any location where industrial radagraphy is pedormed other than the location (s) listed in the specific license or registration.

Authority:

T.C.A. ll4-5-M1 et seq., 68-N2-N3 and 68-N2-MG.

Administrative History: Original rule certified June 7,1974. Amendment filed August is,1978; effectite October 2,1978. Amendment filed April 3,1986; effectise May 31,1986. Amendment filed June 19,1989; effectite September 27,1989. Repeal and new rule filed October 27,1993; effectite January 10,1994.

l IS00-S-8.04 Equipment Control (1)

Limits on levels of radiation for radiographic exposure devices and storage containers:

'(a)

Radiographic exposure devices measuring less than 4 inches (10 centimeters) from the sealed source storage position to any exterior surface of the device shall have no radiation level in excess of 50 milbroentgens per hour at 6 inches (15 centimeters) from any exterior surface of the device.

Radiographic exposure devices measuring a minimum of 4 inches (10 centimeters) from the sealed source storage position to any exterior surface of the device, and all storage containers for sealed sources or for radiographic exposure devices, shall have no radiation level in excess of 200 milliroentgens per hour at any exterior surface, and 10 milhroentgens per hour at I meter from any exterior surface. De radiation levels specified are with the sealed source in the shielded (i.e., "off") position.

b)

Subparagraph (1)(a) of this Rule applies to all equipment manufactured prior to January 10,1992. AAer January 10,1996, radiographic equipment other than storage containers and source changers shall meet the requirements of 1200-2-8.04(10), and paragraph (1) of this Rule applies only to storage containers and source changers.

(2)

Imking of sources of radiation and storage containers:

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(a)

Each source of radiation shall have a lock or outer locked container designed j

to prevent unauthorised or accidental production of radiation, or removal or exposure of a sealed source. Each source of radiation shall be kept locked at i

all times except when under the direct surveillance of a radiographer or a radiographer's assistant who is under the personal supervision of a radiographer, or as may be'otherwise authorised pursuant to Chapter 1200-3-6. Each source changer and storage container shall have a lock and be kept locked when containing sealed sources except when the container or l

l source changer is under the direct surveillance of a radiographer or a j

radaagrapher's assistant under the personal supervision of a radiographer.

(b)

Radaagraphic exposure devices, source changers, and storage containers, shall be locked and surveyed to assure that the sealed source is in the shielded position:

j 1.

Before being moved from one location to another; and i

2.

Before being secured at a given location.

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(3)

Storage precautions: 1.ceked radiographic exposure devices, source changers and i

storage containers shall be physically secured to prevent tampering with or removal j

by unauthorised persons.

j (4)

Radiation survey instruments:

l (a) he licensee or registrant shall maintain calibrated and operable radiation survey instruments to make physical radiation surveys as required by this Chapter and Chapter 1200-2-5 of these regulations.

Instrumentation required by this paragraph shall have a range such that 2 milhroentgens per j

hour through I roentgen per hour can be measured.

(b)

Each radiation survey instrument shall be calibrated:

1.

At energies appropriate for use and at intervals not to exceed three (3) months and after each instrumeat servicing; 2.

Such that accuracy within plus or minus 20 percent can be demonstrated; and 3.

At two or more widely separated points, other than sero, on each scale.

(c)

Records of calibrations, dates and results thereof shall be maintained for inspection by the Division for three (3) years after the date of calibration.

(5)

Leak testing, repairing, taggmg, opening, modifying and replacing of sealed sources:

(a)

De replacement of any sealed source fastened to or contained in a radiographic exposure device and bak testing, repair, taggmg, opening or any other modacation of any sealed source shall be performed only by persons specifically authorised to do so by the Division, the U.S. Nuclear Regulatory Commission, or any Agreement State.

(b)

Each sealed source shall be tested for leakage at intervals not to exceed six 8-4

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(6) months. In the absence of a certificate from a transferor that a test has J

been made within the six (6) months prior to the transfer, the sealed source ehall not be put into use until tested.

i (c)

N leak test shall be capable of detecting the presence of 0.005 microcurie of i

j removable contamination on the asaled source. An acceptable leak test for sealed sources in the possession of a radiography licensee would be to test at the nearest accessible point to the sealed source storage position, or other appropriate measuring point, by a procedure to be approved pursuant to i

1300-3-10.18(6)(e). Records ofleak test resulta shallidentify each sealed j

aource and its container by serial number and shall be kept in units of 1

microcuries or disintegrations per minute (dpm) and maintained for i

inspecten by the Division for three years after the test is made.

4 i

(d)

Any test conducted pursuant to (b) and (c) of this paragraph that reveals the presence of 0.005 microcurie or more of removable radioactive material shall 3

l be considered evidence that the sealed source is leaking. ne licensee shall immediately withdraw the equipment involved from use and shall cause it to j

be decontaminated and repaired or to be disposed of in accordance with Division regulations. Two copies of a report shall be filed within frve (5) days after obtaining results of the test with the Division at its office located at L &

j C Annex,3rd Floor,401 Church Street, Nashville, Tennessee 37243-1532, a

describing the equipment involvsd, the test results and the corrective action j

taken.

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(e)

A sealed source that is not fastened to or contained in a radiographic l

exposure device shall have permanently attached to it a durable tag at least one (1) inch (2.54 centimeters) square bearing the conventional radiation j

caution symbol, as described in Chapter ' 1200-2-6, and at least the l

instructions:

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" DANGER - RADIOACTIVE MATERIAL - DO NOT HANDLE -

NOTIFY CIVIL AUTHORITIES IF FOUND"

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(6)

Quarterly inventory. Each licensee or registrant shall conduct a quarterly physical inventory to account for all sources of radiation received and possessed by him. The records of the inventories shall be maintained for three (3) years from the date of the inventory for inspection by the Division. De records shall include the quantities and kinds of radioactive material, location of all sources of radiation, and the date of inventory. Each sealed source and its radiographic exposure device shall be identiGed by serial number.

(7)

Utilisation logs. Each licensee or registrant shall maintain current logs at the address specified in the license or registration. nose logs shall be kept available for i-three (3) years from the date of the recorded event for inspection by the Division.

l ne logs shall show for each source of radiation the following information:

(a)

A descriptica (make, model and serial number) of each radiographic j

exposure device and, if appropriate, sealed source (s) contained therein; f

(b) ne identity of the radiographer to whom assigned; and i

(c)

Locations (plant or site) where used and dates of use.

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j-4 Inspection and maintenance of redsgraphic exposure devices, source changers, and storage containers.

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(a) he licensee shall check for obvious defects in radsgraphic exposure devices, j

j storage containers and source changers prior to use each day the equipment 1

is used.

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De licensee shall conduct a program of inspectaan and maintenance of i

radiographic exposure devices, source changers, and storage containers at j

intervals not to exceed three (8) months, or prior to the first use thereafter, j-to assure proper functioning of components important to safety. Records of these inspections and maintenance shall be retamed for three (8) years for l

anspection by the Division.

1 (9)

Permanent redsgraphic installations.

(a)

Permanent radsgraphic installations having high radiation area entrance controls of the types described in Chapter 1200-2-4 shall also meet the special requirements in (b) and (c) of this paragraph.

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(b)

Each entrance that is used for personnel access to the high radiation area in l

i a permanent radiographic installation shall have both visible and audible i

warning signals to warn of the presence of radiation. De visible signal shall

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be actuated by radiation whenever the source is exposed or a radiation area 4

is generated. De audible signal shall be actuated when an attempt is made to enter the installation while the source is exposed or a radiation area is generated.

4 (c)

De alarm system shall be tested at intervals not to exceed three (8) months, j

or prior to the first use thereafter of the source of radiation in the i-installation. De licensee or registrant shall retain records of these tests for l

three (8) years for inspectaan by the Division.

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Performance requirements for redsgraphy equipment.

Equipment utilizing radioactive material used in industrial radiographic operations shall meet the

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following minimum criteria:

4 (a)

Each radiographic exposure device and all associated equipment shall meet the requirements speciGed in American National Standard N482-1980

" Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," (published as NBS Handbook 186, issued January i

1981) American National Standards Institute, Inc.,1480 Broadway, New l

York, NY 10018 (ANSI N482). ~

t (b)

In addition to the requirements specified in subparagraph (a) of this j

paragraph, the following requirements apply to radiographic exposure j

devices and associated equipment:

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1 1.

Each radegraphic exposure device shall have attached to it by the j'

user a durable, legible, clearly visible label bearing the:

4 (i)

Chemical symbol and mass number of the radionuclide in the i

device; 1

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Radioactivity and the date on which this radioactivity was l

last measured; i

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Model number and serial number of the sealed source; i

Ov)

Manufacturer of the sealed source; and (v)

IJeensee's name, address and telephone number.

2.

Any radiographic exposure device intended for use as a Type B transport container shall be currently apprwed by the U.S. Nuclear Regulatory Commission as a Type B package accordmg to the j

requirements of 10 CFR Part 71.

j 8.

Mod Seation of any exposure devices and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, controls or guide tubes would not compromise the design safety features of the system.

(c)

In addition to the requirements speci6ed in subparagraphs (a) and (b) of this paragraph, the following requirements apply to radiographic exposure devices and associated equipment that allow the source to be moved out of the device for routine operation:

1.

De coupling between the source assembly and the source control cable shall be designed in such a manner that the source assembly shall not become disconnected if cranked outside the guide tube. De coupling shall be such that it cannot he unintentionally disconnected under normal and reasonably foreseeable abnormal conditions.

2.

De device shall automatically secure the source sesembly when it is I

cranked back into the fully shielded position within the device. This securing system shall only be released by means of a deliberate operation on the exposure device.

8.

De outlet Gttings, lock box and drive cable 6ttings on each radiographic exposure device shall be equipped with safety plugs or covers that shall be installed during storage and transportation to 4

protect the source assembly from water, mud, sand or other foreign matter.

4.

Each sealed source or source assembly shall have attached to it or engraved in it, a durable, legible, visible label with the words:

" DANGER - RADIOACTNE " De label shall not interfere with the safe operation of the exposure device or associated equipment.

5.

He guide tube shall have passed the crushing testa for the control tube as speci6ed in ANSI N482 and a kinking resistance test that closely approximates the kinking forces likely to be encountered during use.

8.

Guide tubes shall be used when moving the source out of the device.

~7.

An exposure head or similar device designed to prevent'the source 8-7

8lp 1

i assembly from passms out of the end of the guide tube shall be attached to the outermost end d the guide tube during redsgraphie operations.

8.

De guide tube exposure head connection shall be able to withstand the tensile test for control units specified in ANSI N482.

9.

Source changers shall prwide a system for assuring that the source i

shall not be accidentally withdrawn from the changer when 1

connecting or %aW the drive cable to or from a source l

assembly.

(d)

All newly manufactured radiographie exposure devices and associated equipment acquired by licensees after January 10,1992, shall comply with the requirements d this paragraph (10).

4 1

(e)

All radiographic exposure devices and associated equipment in use after January 10,1996, shall comply with the requirements of this paragraph (10).

Authority:

T.C.A. ll4-5-M1 et seq., 68-N2-N3 and 68-N2-MG.

Administrative l

Ristory: Original rule certified June 7,1974. Amendment filed August is,1978; effectite October 2,1978. Amendment $ led April 3,1986; effectite May 31,1986. Repeal and nett 1

l rule filed October 27,1993; effectite Jarwary 10,1994.

4 1800-3-8.05 Personal Radiation histy Requirements for Radiographers and Radiographer's Assistants (1)

Traming.

(a)

The licensee or registrant shall not permit any individual to act as a radiographer as defined in this Chapter until such individual:

1.

Has been instructed in the subjects outlined in 1200-2-8.07 and has demonstrated understanding thereof by successful completion of a written test and a field examination on the subjects covered that has been apprwed by the Division; 2.

Has received copies of and instruction in:

(i)

De regulations contained in this Chapter; (ii) ne applicable rules of Chapters 1200-2-5 and 1200-2-9; (iii)

License or registration conditions; and (iv)

De licensee's or registrant's operating and emergency procedures and shall have been tested in a manner approved by the Division to demonstrate understanding thereof; and 3.

Has physically demonstrated competence to use the sources of 8-6

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radiation, nlated handling toole, an i survey instruments that will be j

employed in his assignamt.

c (b) ne licensee or registrant shall as permit any individual to act as a redsgrapher's assistant as $efined in this Chapter until such individual:

i 1.

Has received copies of and instruction in the licensee's or registrant's operating and emergency procedures and shall have been tasted in a i

manner approved by the Division to demonstrate understanding thereof; and 2.

Has physically demonstrated competence to use, under the personal supervision of the radiographer, the sources of radiation, related handling tools, and survey instruments that will be employed in his assignment.

(c)

Records of the above training and testing, including copies of the written tests and dates of oral tests and field examinations, shall be maintained for l

three (8) years for inspection by the Divisica.

i (d)

Whenever a radiographer's assistant uses sour:es of radiation or related handling tools or conducts radiation surveys reg. aired by 1200-24.06(3)(b) i to determine that the sealed source has ruurned to the shielded position after an exposum, he shall be under. the personal supervision of a radiographer.

(2)

Operating and emergency procedures. De licensee or registrant shall submit to the Division a copy of current operating and emergency procedures prior to the issuance i

or renewal of a license or registration. The licensee or registrant shall retain a copy

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of the operating and emergency procedures until the Division terminates the license or registration that authorises the activity for which the procedures were developed.

If the operating and emergency procedures aire superseded, the superseded procedures shall be retained by the licensee or registrant for three (8) years after each change. Dese procedures shall include specific instructions in at least the following:

(a) ne handling and use of sources of radiation to be employed such that no individual shall be exposed to radiation doses in excess' of the limits established in Chapter 1200-2-6 of these regulations; (b)

Methexis and accesions fur conducting radiation surveys; (c)

Methods for controlling access to redegraphic areas; (d)

Methods and occasions for locking and securing sources of radiation; (e)

Personnel monitoring and the use of personnel monitoring equipment;

)

(f)

Transportation to field locations, including packing of sources of radiation in the vehicles, posting of vehicles and control of sources of radiation during transportstion; (g)

Minimizing exposure ofindividuals in the event of an accident; B-9

l (h)

De procedure for notifying proper persons in the event of an accident; i

(i)

Maintenance of records; 6)

De inspection and maingenance of radiographic exposure device and storage containers; and (k)

Steps that shall be taken immediately by radaosrephic personnel in the event a pocket dosimeter is found to be off ecale.

l (8).

Personnel monitoring control.

(a) he licenom or registrant shall not permit any individual to act as a radiographer or as a radiographer's assistant unless, at all times during radiographic operations, each such individual wears a direct-reading pocket dosimeter, an alarm ratemeter, and either a film badge or a j

thermoluminseeent dosimeter (TLD). An alarm ratemeter is not required to be worn in permanent radiography facilities where other appropriate i

alarming or warning devices are in mutine use. Pocket dosimeters shall j

have a range from zero to at least 200 milbroentgens but not greater than 1 roentgen and shall be recharged at the start of each shift. Each film badge and TLD shall be assigned to and worn by only one individual.

(b)

Pocket dosimeters shall be read and exposures recorded daily. The licensee or registrant shall retain each record of these exposures for three (8) years after the record is made.

(c)

Pocket dosimeters shall be checked at periods not to exceed one (1) year for correct response to radiation. Acceptable dosimeters shall read within plus or minus 30 percent of the true radiation exposure.

(d)

If an individual's pocket dosimeter is discharged beyond its range, industrial radiographic operations by that individual shall cease. De individual's film badge or TLD shall be sent for processing immediately. De individual shall not return to work with sources of radiation until a determination of the radiation exposure has been made. Radiation exposures shall be maintained below the dose limita in Chapter 1200-2-6.

(e)

Reports received from the film badge or TLD processor shall be kept for inspection by the Division until the Division authorises disposition.

(f)

If a film badge or TLD is lost or damaged, the worker shall cease work immediately until a replacement film badge or TLD is prwided and the exposure is calculated for the time period from issuance to loss or damage of the film badge or TLD.

(g)

Each alarm ratemeter shall:

1.

Be checked to ensure that the alarm functions properly (sounds) prior to use at the start of each shift; 2.

- Be set to give an alarm signal at a preset dose rate of 500 mR/hr; 3.

Require special means to change the preset alarm function; and 8-10

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Be calibrated at periods not to exceed one year for correct response to i

i radiation. Acceptable retameters shall alarm within plus or minus 20 percent of the true radiation dose rate.

4 Authority:

T.C.A. ll4-5-N1 et esq., 68-N3-N3 and 68-N2-NG. Administrative Ristory: Orismal rule certified June 1,1914. Amendment filed August 15,1918; elfactive October 2,1978. Amendment filed April 3,1986; affective May 31,1986. Repeo! and new j

rule filed October 21,1993; offective January 10,1994.

e 1300-S-8.06 Precautionary Procedures la Radiographic Operations (1)

Security. During each radiographic operation the radiographer or radaagrapher's assistant shall maintain a direct survedlance of the operation to protect against unauthonzed entry into a high radiation area as defined in Chapter 1200-2-6 except:

(a)

Where the high radiation area is equipped with a control device or alarm system as required in Chapter 120G-2-6 of these regulations; or (b)

Where the high radiation area is locked to protect against unauthorized or accidental entry.

(2)

Posting. Areas in whh:h radiography is being performed shall be conspicuously posted according to the standards set out in Chapter 1200-2-6, without exceptions.

(3)

Radiation surveys and survey records.

i (a) ne licensee or registrant shall ensure that at least one calibrated and j

operable radiation survey instrument is available:

1.

At the location ofits radiographic operations; and i

2.

At the storage area, as defined in 1200-2-8.08, whenever a radiographic exposure device, a storage container or source is being placed in storage.

(b)

After each exposure, the licensee or registrant shall ensure that a survey with a calibrated and operable radiation survey instrument is made to determine that the sealed source has been returned to its shielded position or that the radiation from the radiation machine has been terminated. De entire circumference of the radiographic exposure device shall be surveyed.

If the radiographic exposure device has a source guide tube, the survey shall include the guide tube.

(c)

Any time a radiographic exposure device is placed in a storage area, the licensee shall ensure that a survey with a calibrated and operable radiation survey instrument is made to determine that the sealed source is in its shielded position. De entire circumference of the radiographic exposure device shall be surveyed. He results of the last storage survey of the workday, required by this subparagraph (c), shall be recorded and retained for three (S) years.

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(d)

Records shall be kept of the duration of each radiographic exposure and the number of exposures made. In addition, for each radiographic exposure i

employing a radiation machine the voltage and current used shall be noted.

j

'Ihese records shall be maintained for three (3) years for inspection by the Division and for field work pay be kept on the area survey form.

2 (e)

Each licensee or registrant conducting industrial redsgraphy at a temporary jobsite shall have the folkming documents available at that site for inspection by the Division:

1.

Appropriate license or registration;

2. -

Operating and emergency procedures; 8.

Applicable regulations; 4.

Survey records required pursuant to 1200-2-6.06 and Chapter 1200-2-6 for the period of operation at the site; l

5.

Daily pocket dosimeter records for the period of operation at the site:

ud E

6.

The latest instrument calibration and leak test records for specific devices in use at the site. Acceptable records include tags or labels j.

that are affixed to the device or survey meter.

Authority:

T.C.A. Il4-5-M1 et seq., 68-N2-N3 and 68-N2-MG.

Adminletrative History: Original rule certi6ed June 7,1974. Amendment fEled August 15,1978; effective October 2,1978. Amendment filed April 3,1986; effective May 31,1986. Amendment filed June 19,1989; effective September 27,1989. Repeal and new rule filed October 27,1993; i

effective January 10,1994.

1200-3-8.07 Minimum Subjects To Be Covered in Training Radiographers (1)

Fundamentals of radiation safety.

(a)

Characteristics of

• and gamma radiation.

I (b)

Units of radiation dose and quantity of radioactivity.

(c)

Hazards of exposure to radiation.

(d) levels of radiation from sources of radiation to be used.

(e)

Methods of controlling radiation dose and exposure.

1.

Working time.

2.

Working distance.

3.

Shielding.

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(2)

Radiation detection instrumentation to be used.

4 (a)

Use ot radiation survey instruments.

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1.

Operation.

2.

Cahbration.

8.

Limitations.

(b)

Survey techniques.

1 (c)

Use of personnel monitoring equipment.

1.

Film badges and thermoluminescent dosimeters (TLDs).

2.

Pocket dosimeters.

3.

Alarm ratemeters.

(3)

Radiographic equipment to be used.

(a)

Remote handling equipment.

(b)

Radiographic exposure devices and sealed sources.

(c)

Storage containers.

(4)

The requirements of pertinent state regulations.

(5)

The licensee's or registrant's written operating and emergency procedures.

(6)

Case histories of radiography accidents.

Authority:

T.C.A. Eft-5-N1 et seq., 68-N2-N3 and 68-N2-MG. Administrative History: Ongmal rule certi6ed June 7,1974. Amendment (ded August is,1978; etlective October 2,1978. Amendment fded April 3,1986; effective May 31,1986. Repeal and new rule (ded October 27,1993; effectitt January 10,1994.

1200-S-8.08 Cabinet Radiography

'Ihe only requirement of this Chapter which applies to cabinet radiography as defined in this Chapter is that no registrant shall permit any individual to operate a cabinet radiography unit until such individual has:

(1)

Received a copy of the operating procedures for the unit; (2)

Received instruction in the operating procedures; (3)

Demonstrated an understanding of the operating procedures; and (4)

Demonstrated competence in the use of the unit.

8-13

1 i Authority:

T.C.A. Il4-6-Mi et seq., 68-N2-N3 and 68-MS-MG.

Administrative l

Bistory: Origmal rule certified June 7,1974. Amendment Bled August is,1978; elfective i

October 2,1978. Amendment filed April 3,1986; affecuve May 31,1986. Repeal and new rule filed October 27,1993; affective January 10,1994.

1900-s-4.00 Muoroscopic Radiography i

Radiography utilizing Guoroscopy should be done only by remote observation; however, if direct viewing of the screen by personnel is used, the registrant shall demonstrate that radiadon expoeure limita are not exceeded.

Authority:

T.C.A. Il4-5-M1 et seq., 68-N2-M3 and 68-N2-206. Administrative History: Original rule certilled June 7,1974. Amendment filed August 15,1978; affective i

October 2,1978. Amendment filed April 3,1986; etfactive May 31,1986. Repeal and new rule fEled October 27,1993; effective January IC,1994.

t 4

j 130bS-8.10 Required Administrative Procedures for Industrial Radiography

]

Program (1)

Licensees and registrants shall have a program for training radiographers and radiographer's assistants and submit to the Division for approval a schedule or description of such program that includes the:

(a)

Initial training:

1.

This initial training shall consist of a complete training program as outlined in 1200-2-8.07 or 2.

Resumes of prior training and experience of individuals that show fulfdlment of the requirements of 1200-2-8.07(1) and (2) and the initial training of such individuals in the licensee's or registrant's specific radiography program as outlined in 1200-2-8.07(3), (4) and (5);

(b)

Periodic training (shall be at least annual);

(c)

On-the-job training; (d)

Means to be used by the licensee or registrant to determine the radiographer's knowledge and understanding of and ability to comply with:

1.

Division regulations and licensing or registration requirements; and 2.

'!he licensee's or registrant's operating and emergency procedures; and (e)

Means to be used by the licensee or registrant to determine the radiographer's assistant's knowledge and understanding of and ability to comply with the licensee's or registrant's operating and emergency procedures; l

8-14 i

.~.

)8

! E j

(2)

He licensee or regstrant shall establish and submit to the Division for approval written operating and emergency procedures as described in 1200-2-8.05(2);

i (3)

De licensee or registrant shall establish and submit to the Division a description of j

its inspectaon program adequate tosneure that its radiographers and radiographer's i

assistants follow the Division's regulatory requirements and the licensee's or registrant's operating and emergency procedures. De inspection program shall:

1 (a)

Include observation of the performance of each radaagrapher and.

}

radiographer's assistant during an actual radiographic operation at intervals 1

)

not to exceed three (8) months; (b)

Provide that if a radiographer or a radiographer's assistant has not participated in a radaagraphic operation for more than three (8) months since the last inspection, that individual's performance shall be observed and recorded the next time the individual participates in a radaographic operation; and (c) laclude the retention of inspection records on the performance of radiographers or radiographer's assistants for three (8) years; (4)

He licensee or registrant shall submit to the Division a description of his overall organizational structure pertaining to the radiography program, including specified 3

delegations of authority and responsibility for operation of the program; and (5)

The licensee who desires to conduct his own leak testa shall establish procedures to be followed in testing sealed sources for possible leakage and/or contamination and shall submit to the Division for approval a description of such procedures including:

(a)

Instrumentation to be used; (b)

Method of performing testa, e.g., points on equipment to be smeared and method of taking the smear; and (c)

Pertinent experience of the person who will perform the test.

Authority:

T.C.A. If4-5-Ni et seq., 66-N2-N3 and 68-NR-MG.

Administrative History: Orivnal rule certilled June 7,1974. Amendment JUed August 15,1978; elfective October 2,1978. Amendment fUed April 3,1986; effective May 31,1986. Amendment filed June 19,1989; effective September 27,1989. Repeal and new rule filed October 27,1993; effective January 10,1994.

)

1800-S-6.11 Shielded Roosa X-Ray Radiography De only requirements of this Chapter applying to shielded room x-ray radiography are as follows:

I (1)

All entrances into the shielded race shall be provided with interlocks. After an interlock has been interrupted, broken, or tripped, it shall be possible to cause x-rays to be produced again only from the control panel. Interlocks shall not be used to shut off the x-ray equipment except in an emergency or during testing.

B-15

i t,.

(I)

Emergency shut-eff switches shah be located within the high radiation areas so as to be whle to individuals therein within the warning period in subparagraph 3

(1)(e). Dese switches and their mode of operation shall be identiGod by a j

conspicuously posted sign a4acent to the switch. De emergency shutadf switches j

shall include a manual reset that must be reset at the switch before x-rays can again be produced from the control' panel. AAer an emergency shut-cir switch has been activated, it shall be possible to produce x-rays again only from the control panel.

i (3) he interlock system and the emergency shutadisystem shall be separate electneal and/or mechanical systems.

(4) he interior of the shielded room shaU be prwided with flashing or rotating warning lights that operate when, and only when, radiation is being produced. Rose lights

~

shall be so positioned that they can be observed from any position or orientation within the room.

l l

(5)

An audible warning signal within the room shall be actuated for at least ten (10) i seconds immediately prior to the first initiation c(radiation after the closing of any opening that can admit personnel.

(6) ne x-ray equipment control panel shall be prwided with a locking device to prevent unauthorized use. Such locking device shall, when locked, prevent the production of x-ray radiation by the equipment.

(7)

All entrances into the shielded room shall be prwided with a conspicuously visible I

warning device, which need not be flashing or rotating but which operates only j

when radiation is being produced.

(8)

Surveys shall be made as required in 1200-2-6.06(3)(b).

Personnel devres prwiding an audible signal when activated by radiation will be acceptable for this survey. Proper operation of this device shall be checked daily and a record maintained of this check. AU personnel working with the x-ray equipment shall be prwided with such a device. His device shall be designed so as to clearly indicate entry into a 2 milhroentgen per hour x-ray radiation 6 eld.

(9)

All personnel associated with the x-ray equipment shall be prwided with personnel monitoring devices that shall be calibrated for the x-esy energies being utilized.

Records of personnel exposure shall be maintained as required in Chapter 1200-2-5.

(10)

No registrant shall permit any individual to operate a radiation machine for shielded room x-ray radiography until such individual has received a copy of, instruction in, and demonstrated an understanding of operating and emergency procedures for the unit, and competence in its use. (See 1200-2-4.06(2)(a), (c), (d),

(e), (g), (h), (i), G) and (k)). Dese operating and emergency procedures shall be submitted to the Division for apprwal prior to their adoption.

(11)

All safety and warning devices, including interlocks and emergency shutwdf switches, shall be tested at intervals not to exceed three (3) months to determine that they are functioning properly. Records shall be maintained of all tests.

(12)

If a safety or warning device malfunctions, the x-ray control panel shall be locked in the "off' position. It shall not be used, except as may be necessary for repair or

• replacement of the malfunctioning safety or warning device, until the safety or 8-16

.. ~ -

i.

j j

j warning device is functioning properly.

I Antherity: T.CA. Il4-5-N1 et seq., 66-N2-N3 and 68-M2-MG.

Administrative 1

Eistory: Original rule certified June 7,1974. Amendment filed August 15,1978; affective 1

October 2,1978. Amendment JEled April 3,1986; effective May 31,1986. Repeal and new rule filed October 21,1993; elfective January 10,1994.

i i

u-n m.,oru n,

nir

.ta i

(1)

In addition to the reporting requirements specified in other chaptere of these i

regulations, each licensee or registrant shall provide a written report to the Direision i

af Radiological Health, L & C Annen, 3rd Floor, 401 Chumh Street, Nashville, l

Tennessee 87348-1682, within 80 days of the occurrence of any of the followmg f

incidents involving radiographic equipment:

i (a)

Unintentional disconnectaan of the source assembly from the control cable.

i i

(b)

Inability to retract the source assembly to its fully shielded position and i

secure it in this position.

l J

(c)

Failure of any component (critical to safe operation of the device) to prop erly perfonn its intended function.

i i

(I)

'!he licensee or registrant shall include the following information in each report l

submitted under (1) of this Rule-i f

(a)

A description of the equipment problem.

4

}

(b)

Cause of each incident,if known.

(c)

Manufacturer and model number of equipment involved in the incident.

(d)

Place, time and date of the incident.

i (e)

Actions taken to establish normal operations.

t (f)

Corrective actions taken or planned to prevent recurrence.

4 (g)

Qualifications of personnel involved in the incident.

t (3)

Reports of overexposure submitted under Chapter 1200.-2-6 that involve failure of safety components of radiography equipment shall also include the information speci6ed in (2) of this Rule.

8-17

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1-N Page 1 of 11 Pages OM RULEMAKING HEARING RULES l

OF l

TENNESSEE DEPARTMENT OF ENVIRONMENT AND CONSERVATION DIVISION OF RADIOLOGICAL HEALTH CHAPTER 1300-8-8 STANDARDS FOR PROTECTION AGAINST RADIATION AMENDMENTS 2

Rule 1200-3-6.32 DEFINITIONS is amended by adding the following definitions in alphabetical order:

(1)

Auditable form of records means records that comply with the forms desenbed in l

1200-2-5.139 and that are maintained accessible for review by the Division's j

mspectors.

l (2)

Authorised user means:

(a)

A licensed physician, dentist, or po&atrist who is identified as an authorized j

user for human use on:

l 1.

A Nuclear Regulatory Commission or Agreement State license, or i

2.

A permit issued by a Nuclear Regulatory Commission or Agreement State specific licensee of broad scope; or i

(b)

A licensed physician who is authorized to administer therapeutic radiation g

machine therapy.

i (3)

Diagnostic clinical procedures manual means a collection of written radiopharmaceutical diagnostic procedures approved by the authorized user that:

1 1

(a)

Describes each method (and other instructions and precautions) by which a

the licensee performs radiopharmaceutical & agnostic clinical procedures; and (b)

Includes the radiopharmaceutical, dosage, and route of administration.

(4)

Misodministration means the administration of:

(a)

A radiopharmaceutical dosage greater than 30 microcuries of either modium iodide I-125 or I-181:

1.

Involving the wrong patient, wrong human research subject, or wrong radiopharmaceutical, or 2.

When both:

(i)

The administered dosage differs from the prescribed dosage by more than 20 percent of the prescribed dosage, and (ii)

'Ite administered dosage differs from the prescribed dosage ATTACHMENT 4

('-

/+

Pag) 2 of 11 Pages v

by more than 80 microcuries; (b)

A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-181:

1.

Involving the wrong patient, wrong human research subject, wrong radiopharmaceutical, or wrong route of administration, or 2.

When the administered dosage differs from the preferibed dosage by more than 20 percent of the prescribed dosage; (c)

A stereotacts: radiosurgery radiation dose:

1.

Involving the wrong patient, wrong human research subject, or wrong treatment site, or 2.

When the calculated total administered dose differs from the total prescribed dose by more than 10 percent of the total prescribed dose; (d)

A teletherapy radiation dose:

1.

Involving the wrong patient, wrong human research subject, wrong mode of treatment, or wrong treatment site, 2.

When the treatment consists of three (3) or fewer fractions and the calculated total administered dose differs from the total prescribed -

dose by more than 10 percent of the total prescribed dose, 3.

When the calculated weekly administered dose exceeds the weekly prescribed dose by 30 percent or more of the weekly prescribed dose, or 4.

When the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose; (e)

A brachytherapy radiation dose:

1.

Involving the wrong patient, wrong human research subject, wrong radioisotope, or wrong treatment site (excluding, for permanent j

implanta, seeds that were implanted in the correct site but migrated 4

outside the treatment site),

2.

Involving a sealed source that is leaking, 8.

When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure, or 4.

When the calculated administered dose differs from the prescribed dose by more than 20 percent of the prescribed dose; (f)

A diagnostic radiopharmaceutical dosage, other than quantities greater than 30 microcuries of either sodium iodide I-125 or I-131, both:

1.

Involving the wrong patient, wrong human research subject, wrong

.l*^

f.

Page 3 of11 Pages 4

radiopharmaceutical, wrong route d administration, or when the administered dosage di5ers from the preecribed dosage; and

)

2.

When the dose to the patient exceeds 5 roms (50 millisieverts) j

?

effective dose equivalent or 50 rem (500 millisieverta) dose equivalent i

i to any individualorgan;or (g)

A therapeutic radiation machine dose:

3.

Involving the wrong patient, wrong human research subject, wrong i

mode of treatment, or wrong treatment site, l

2.

When the treatment consists of three (8) or fewer fractans and the calculated total administered dose differs from the total prescribed

]

dose by more than 10 percent of the total prescribed done, 3.

When the calculated weekly administered dose exceeds the weekly l

prescribed dose by 30 percent or more of the weekly prescribed dose, 3

or j

4.

When the calculated total administered dose differs from the total j

prescribed dose by more than 20 percent of the total prescribed dose.

(5)

Prescribed dosage means the quantity of radiopharmaceutical activity as documented in:

(a)

A written directive; or (b) ne diagnostic clinical procedures manual.

(6)

Prescribed dose means:

(a)

For stereotactic radiocurgery, the total dose as documented in the written directive; (b)

For teletherapy, the total dose and dose per fraction as documented in the written directive; (c)

For brachytherapy, either the total source strength and exposure time or the total done, as documented in the written directive; or (d)

For therapeutic radiation machine therapy, the total dose and dose per fraction as documented in the written directive.

(7)

Recordo63e comt means the administration of:

(a)

A radiopharmaceutical or radiation without a written direetwe where a written directue is required; j

(b)

A radiopharmaceutical or radiation where a written directwe is required without daily recording of each administered radiopharmaceutical dosage or radiation dose in the appropriate rooord; (c)

A radiopharmaceutical dosage greater than 30 microcuries of either sodium i

)

• 4 I'

Page 4 of 11 Pages 7;.

}

iodide I-136 orI-181 when both:

1.

He administered dosage difers from the prescribed dosage by more than 10 percent of the preecnbed dosage, and -

2.

De administered d5 ease diners fran the prescribed dosage by more than 15 microcuries; J

l (d)

A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or 1-131, when the administered dosage diners from the presenbed dosage j

by more than 10 percent of the prescribed dosage; k

(e)

A teletherapy radiation dose when the calculated weekly administered dose saceeds the weekly presenbod done by 15 percent or more of the weekly prescribed dose; (f)

A brachytherapy radiation dose when'the calculated administered dose l

difers from the presenbed dose by more than 10 percent of the prescribed done; or i

(g)

A therapeutic radiation machine dose when the calculated weekly administered dose exceeds the weekly prescribed dose by 15 percent or mora of the weekly prescribed dose.

t j

(8)

Therapeutic radmilan machine means x-ray or electron-producing equipment designed and used for external beam radiation therapy.

j l

(9)

Written directive means an order in writing for the administration of radiation to a epecific patient or human research subject, dated and signed by an authorized user.

j Specific requirements for written directives are covered in 1200-2-5.75.

Statutory Authority: T.C.A. 4-5-201 et seg.; T.C.A. 68-202-203 and 206.

Rule 1200-2-6.75 RESERVED is amended by deleting the word " RESERVED" and adding the following language so that, as amended, Rule 1200-24.75 shall read:

1200-S 4.76 Quality Management Program for Human Use (1)

Licensees and appbeants for licensure involving human use, and registrants and applicants for registration involving human use for therapy or research, shall establish and maintain a written quality management program. De purpose of the quality management program is to assure that radioactive material or radiation shall be administered as directed by the authonsed user. De quality management program shallinclude written policies and procedures to meet the following specific objectives:

-(a) hat, prior to the administration of a radiopharmaceutical or radiation, except as specified in subparagraph (1)(b)6 of this Rule, a written directive is prepared containing information as folkms:

w r

1

.~

1 Page 5 of11 Pages l

1.

For any administration of quantities gnater than 80 microcuries of either sodium iodide I-125 or I-181: the dosage, l

2.

For a therapeutic administration of a radiopharmaceutical other i

than sodium iodide 1-125 or I-181: the radiopharmaceutical, dosage, j

and route of administration, j

8.

For stereotactic radiosurgery: target coordmates, collimator sise, i.

total done, and, if appropriate, plus pattern, t

For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period, 5.

For highwlose-rate remote afterloading brachytherapy:

the radioisotope, treatment site, and total dose, 6.

For all other brachytherapy:

(i)

Prior to implantation: the radioisotope, number of sources.

l and source strengths, and I

a (ii)

After implantation but prior to completion of the procedure:

the niioisotope, treatment site, and total source strength l

and exposure time (or, equivalently, the total dose), or 2

7.

For therapeutic radiation machine therapy: the total dose, dose per 1

fraction, treatment site, and overall treatment period; (b)

That oral directives or misions to written directives may be made as follows:

1.

If a written revision to an existing written directive would delay 3

administration and thmby jeopardize the patient's health, an oral mision to an existing written directive is acceptable, provided:

i (i) ne oral mision is documented immediately in the patient's record, and i

(ii) ne authorized user issues a mised written directive within l

24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral revision.

2.

A written mision to a written directive may be made if the mision i

is signed and dated by an authorized user prior to the administration.

s (c)

Dat each facility that pedorms radiopharmaceutical dugnostic procedures shall have a diagnostic clinical procedures manual; (d) nat, prior to each administration, the patient's or human research subject's identity is verified by two or more independent methods or persons as the individual named in the written directive; (e) nat final treatment plans and related calculations for brachytherapy, teletherapy, stereotactic radiosurgery, and therapeutic radiation machine

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

i i

t, e

Page 6 of11 Pages j

therapy agree with the respective written daractives;

()

hat each administration is in accordance with the written directive or the diagnostic clinical procedures manual; and (g) hat any unintended devistaan from the written directive or the diagnostic

]

clinical procedures manual is identified and waluated, and appropriate action is taken pursuant to these rules.

1 (2)

Licensees and registranta shall:

(a)

Develop procedures for and conduct a rwiew of the quality management i

program Mese reviews shall:

1.

Include, since the last review, an evaluation of:

(i)

A representative sample of patient and human research subject administrations,

)

(ii)

All recordable events, and (iii)

All misadministrations; and 2.

Be conducted at intervals no greater than 12 months to verify compliance with all aspects of the quality management program; (b)

Evaluate each review to determins the effectiveness of the quality management program in meeting the objectives of paragraph (1) of this Rule.

he quality management program shall be modified if needed to assure the objectives are met; and (c)

Retain records of each review, including the evaluations and findings of the review, in an auditable form for three (3) years.

J (3)

Licensees and registranta shall evaluate and respond to each recordable event within 30 days after discovery by:

(a)

Assembling the relevant facts including the cause; (b)

Identifying what, if any, corrective action is required to prevent recurrence; and (c)

Retaining a record, in an auditable form, for three (3) years, of the relevant facts and what corrective action, if any, was taken.

i i

(4)

Licensees and registrants shall evaluate and respond to each misadministration in accordance with Rule 1200-2-6.146.

l (5)

Licensees and registrants shall retain in an auditable form for three (3) years:

i (a)

Each written directive; and (b)

A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in paragraph (1)(a) above.

I

tI t,

Page 7 of11 Pages 4'

(S)

Licensees or registrants may modify the quality management program to increase i

the program's ofBeiency provided the program's effectiveness is not decreased.

licensees or registrants shall furnish modiGeations to the Division within 30 days l

after modancations have been made.

l

\\

t j

(8)

Implementation of the quality man'agement program-(a)

Each applicant for a new license involving human use shall submit to the Division a quality management program as part of the application for a j

license. Applicants shall implement the program upon issuance of the heense by the Division.

(b)

Each applicant for a new registration involving human use for therapy or research shali submit to the Division a quality management program as part 3

of the application for a registration.

Applicants shall implement the pmgram upon issuance of the registration by the Division.

(c)

On or before October 1,1996, any licensee authorized for human use and any registrant authorized for human use for therapy or research, shpU j

{

submit to the Division, a copy of the quality management program and a written certincation that it has been implemented.

l Statutory Authority: T.C.A. 4-5-201 et seq.; T.C.A. 68-202-203 and 206.

i Rule 1200-2-5.76 RESERVED is amended by deleting the word

• RESERVED" and adding the following language so that, as amended, Rule 1200-2-5.76 ehall read' 1800-S-5.76 Supervision Required by Licenses and Registrations Involving Human Use (1)

Licensees and registrants authorised for human use who permit an individual supervised by an authorized user to receive, possess, prepare, use, or transfer sources of radiation shall:

(a)

Require an authorized user to be immediately available to communicate with the supervised individual; (b)

Allow human use only by speci6cally trained individuals, permitted under state and local regulations, and designated by the authorized user; (c)

Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of sources of radiation and in the licensee's or registrant's written quality management program; and (d)

At intervals not greater than 12 months:

1.

Review the supervised individuars use of sources of radiation, 2.

Provide re-instruction as needed, and

Page 8 of 11 Pages j

8.

Review the records kept to reDeet this use.

CE)

Licensees or registranta shall require the supervised individual to:

i (a)

Fonow the instructions of the supervising authorised user; (b)

Fonow the written radiation safety and quality management procedures established by the licensee or registrant; and i

(c)

Comply with these regulations and the license or registration conditions governing the use of sources of radiation.

a I

(8)

Licensees and registrants authorised for human use that supervise an individual are j

responsible fo-the acts and omissions of the supervised individual.

Statutory Authority: T.C.A. 4-6--201 et seq.; T.C.A 68-202-203 and 206.

4 i

l Rule 1200-2-5.146 RESERVED is amended by deleting the word " RESERVED" and adding the folkming language so that, as amended, Rule 1200-2-6.146 shall read:

I 1300-8 4.146 Notl8 cations, Records, and Reports SpeciSc to Misadministrations (1)

The licensee or registrant shall notify the Division by telephone no later than the next working day after discovery of a misadministration. The telephone number of the Division is (615) 532-0364.

(2) ne licensee or registrant shall submit a written report to the Division at the address given in Rule 1200-2-4.07 within 15 days after discovery of a misadministration.

(a)

The written report shallinclude:

1.

The licensee's or registrant's name; 2.

The prescribing physician's name; 3.

A brief description of the event; including the prescribed dose or dosage and the administered dose or dosage; 4.

Why the event occurred; 5.

Corrective actions taken; 6.

De effect or possible effect on the patient or human research subject; 7.

What improvements are needed to prevent recurrence; 8.

Actions taken to prevent recurrence; and

h#

~' '*

Page 9 of 11 Pages L.,

i 9.

Whether the licensee or regatrant notified the patient or human i

research subject, or the person having lawful authority to make medical decisions for the patient or human remarch subject. [Unless j

otherwise indicated, the patient or human research subject or the person having lawful authority to make medical decisions for the patient or human research subject, shall be subuquently referred to 1

as the human subject in this Rule.)

(i)

If the human subject was not noti 6ed, indicate why not, or (ii)

If the human subject was noti 6ed, indicate what information was provided to that individual.

}

(b)

De report shall not include the human subject's name or other information that could lead to identi6 cation of the patient or human remarch subject.

(3)

The licensee or registrant shall notify the referring physician and the human subject of the misadministration within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery.

(a)

Noti $ cation to the human subject is not required if the referring physician personally informs the licensee or registrant either that:

1.

De referring physician willinform the human subject, or 2.

Based on his medical judgment, telling the human subject would be harmful to the human subject.

(b)

De licensee or registrant is not required to notify the human subject without first consulting the referring physician. If the referring physician or the human subject 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 or registrant shall notify the human subject as soon as possible thereafter.

(c)

De licensee or registrant may not delay any appropriate medical care for the patient or human research subject because of any delay in noti $ cation.

S-e. 7e includes care necessitated by the misadministration.

(4)

If the human subject was notified, the licensee or registrant shall furnish, within 15 days after decovery of the misadministration, a written report to the human subject.

This shall be done by sending either:

(a)

A copy of the report that was submitted to the Division; or (b)

A brief description of the event and the conuquences to the patient or human ruearch subject, provided a statement is included that the report submitted to the Division can be obtained from the licensee or registrant.

(5)

Licensees and registrants shall retain a record of each misadministration in an auditable form for Sve (5) years. De record shall contain:

(a)

De names of all individuals involved in the misadministration (including the prescribing physician, allied health personnel, the patient or human ruearch subject, and the patient's or human remarch subject's referring h

P ysician);

. 4. 3 J4 I-Page 10 of 11 Pages (b) ne patient's or human research subject's social security number, or other identiBcation number if one has been assigned by the licensee or registrant:

ud 5

(c)

A brief description of the miandministration,induding:

1.

De prescribed dose or dosage and the administered dose or dosage, 2.

Why it occurred, 1

8.

He effect or possible effect on the patient or human research

subject, 4.

Corrective actions taken, 1

5.

What improvements are needed to prevent recurrence, and 6.

De actions taken to prevent recurrence.

l (6)

Aside from the notification requirement, nothing in this section affects any rights or duties of heensees, registrants and physicians in relation to each other or human subjects.

Statutory Authority: T.C.A. 4-5-201 et seq.; T.C.A. 68-202-203 and 206.

j d

d legal

Contact:

Party who will approve finalcopy:

Greer C. Tidwell, Jr.

Barbara A. Davis TDEC Office of General Counsel TDEC Division of Radiological Health 20th Door L&C Tower 3rd Door LAC Annex 401 Church Street 401 Church Street Nashville,TN 3724bl548 Nashville,TN 37243-1532 (615) 532-0131 (615) 532-0364

Ai se Page 11 of 11 Pages o

e Signature of the agency officer or officers riirectly responsible for proposing and/or draftmg these rules:

Michael H. Mobley, Director Barbara A. Davis Division of Radiological Health Division of Radiological Health I certify that this is an accurate and complete copy of rulemaking hearing rules lawfully promulgated and adopted by the Department of Environment and Conservation, Division of Radiological Health, on the day of 19 Further, I certify that these ruim are properly presented for fihng, a notice of rulemaking hearing has been filed in the Department of State on the day of 19 and such notice of rulemaking hearing having been published in the l

19

. issue of the Tennessee Administrative Resister, and such rulemaking hearing having been conducted pursuant thereto on the day of 19 Justin P. Wilson, Commissioner Tennessee Department of Environment and Conservation Subscribed and sworn to before me the day of 19 Notary Public My commission expires on the day of 19 All rulemaking hearing rules provided for herein have been examined by the Attorney General and Reporter of the State of Tennessee and are approved as to legality pursuant to the provisions of the Administrative Procedures Act, Tennessee Code Annotated. Title 4, Chapter 5.

Charles W. Burson Attorney General and Reporter ne rulemaking hearing rules set out herein were properly filed in the Department of State on the day of 19 and will become effective on the day of 19 Riley C. Darnell Secretary of State By