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RETURN CONCURRENCE COPY TO NMCELROY, 396-SS RA13-/
07 M 05 f)DG M.32 The Honorable Morris K. Udall, Chairman Subcommittee on Energy and the Environmant Committee on Interior and Insular Affairs United States House of Representati,ves ilashington, D. C.
20515
Dear Mr. Chairman:
The Nuclear Regulatory Commission (NRC) is proposing to revise its regulations that apply to the medical uses of radioisotopes.
The NRC has licensed about 2200 medical facilities and 300 physicians in private practice to use radioactive materials to diagnose and to treat pati ^ents. The NRC receives about 100 new applications, 500 renewal requests, and 1800 license amendment requests each year.
Due to the evolution in the cedical use of radioisotopes over the last thirty years, radiation safety requirements that apply to medical use are fouad throughout the regulations, regulatory guides, standard license conditions and other sources. Therefore, license applicants must submit a substantial amount of information,to show that all radiation safety requirements will be met, including a description of the radiation safety procedures used in neeting the requirements, available facilities and equipment, and key. users' training and experience. The Agency reviews the applicant's prograa bafore issuing a license. The Agency nust approve any cilange in a licensee's radiation safety program.
The primary purpose of the proposed revision is to consolidate the requirements. Under the proposal, all requirements would be clarified and published in one placa,10 CFR Part 35 of HRC regulations. The revised regulation would give both licensees and NRC staff a clearer basis for licensing, operation, and inspection activities. This will make regulation simpler and more efficient for both licensees and the Agency.
8509230'473 85o906 PDR PR 35 50FR30616 PDR
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The Honorable Forris K. Udall The tiRC staff will continue to review the applicant's radiation safety procedures to deternine whether they are adequate to meet the requirements of the regulations, liovever, to perait licensees to nake prompt use of new safety metnods and to adjust their radioactive aaterials programs to meet n:.nt needs caused by changes in demand for patient care services or patient load, licensees would be able to make minor changas in their radiation safety programs without iiRC review provided the regulations are nat.
Changes would require approval of the licensee's Radiation Safety Officer, and at a hospital, its Radiation Safety Connittee.
Some types of program changes that would still require a formal IRC reviea and license amendnent include adding new physician users, new medical uses, and new locations of use.
The proposed revision of 10 CFR Part 35 of l!RC regulations will be published for public comnent in the Federal Register. The proposed regulation and a draft regulatory guide will oe uailed to current licensees and other interested individuals for coment.
Sincerely, (Signed) John G. Davis John G. Davis, Director Office of t'uclear l'aterial Safety and Safeguards
Enclosures:
Identical letters sent to:
1.
Proposed revision of 10 CFR The Honorable Edward J. Markey, Chairman Part 35, " Medical Use of Subcommittee on Energy Conservation and Power Byproduct flateriala Committee on Energy and Commerce 2.
Oraft Public Announcement United States House of Representatives Washington, D. C.
20515 cc: Rep. Manual lujan cc:
Rep. Carlos Moorhead DISTRIBUTION FCML r/f The Honorable Alan K. Simpson, Chairman FC' Central File Subcommittee on Nuclear Regulation NMSS r/f Committee on Environment and Public Works NLMcEl roy United States Senate JHickey Washington, D. C.
20510 VLMiller DRChapell cc:
Senator Gary Hart RECunningham DBMausshardt JGDavis f
JDelmedico-0CA
- See previod's concurrence omce >
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8.l s;, Led Source Documents.for the Revision of Part 35 The following list identifies specific sections of source documents that were used in the revision of 10CFR Part 35 " Human Use of Byproduct Material."
The list is not complete because it only identifies principle sources.
Informal contacts with recognized experts, the regulated industry, and NRC staff are not identified. There is no inference to be drawn from the order of appearance.
Source Documents 10CFR Part 35 United States Pharmacopeia XX FRN's, NRC letters NMSS Mobile Service checklist AAPM petition Teletherapy Calibration Meeting Code of Practice for x-ray therapy ANSI Guidelines for maintaining Cobalt-60 ANSI Procedures for periodic inspection ANSI Dose Calibrators ANSI Instrumentation test and calibration Regulatory Guide 8.18 ALARA at Medical Institutions Material Licensing Branch Standard Conditions Draft Regulatory Guide for Teletherapy Regulatory Guide 10.8 Medical Programs nlm 3-15-83
t Source Documents for Revision of Part 35 Source Disposition
-35 1 Purpose and Scope 35 1 35 2 License Required 35 2 35 3 ~ Definitions 35 15; human use and physician redefined; others words added 35.A Application form 35 16 35 11 Specific licenses... institutions a meet 30 33 351 requires compliance with Part 30' b Medical Isotopes Committee 35 31 c Adequate facilities deleted; not radiation safety d AU has T&E Subpart J e Previous exper;tence Subpart J 35 12 Specific licenses... individuals al meet 30 33 351 requires c.ompliance with Part 30 2 outside a medical institution 35 16 3 access to a hospital deleted; not radia, tion safety 4 AU has T&E Subpart J bl use at a medical institution is limited 35 35; 35 80 2. bring in and take out 35 80; 20 301 3 medical institution has no license deleted; would interfere with medical care at an '
institution with no AU 35.13 Specific license... Sealed Source a meet 30 33 351 requires compliance with Part 30 b AU has T&E Subpart.J 3514 Specific license for groups al meet 35 11, 35 12, or 35 13 see discussion above 2 AU has T&E Subpart J
-3 AU has T&E Subpart J 4 _ adequate instruments implicit by requiring certain. measurements 5 adequate procedures 35 33; guidar :e given in new RG10.8 b1 to 3 limits authorized suppliers 35 49 41 follow generator and kit instructions 35 200 11 measure Mo-99 ' concentration 35 204 l-111 dont use if contaminat'ed 35 204; limit changed l-iv recordkeeping 25 204a 51 leak te'st sealed sources 35 59b 11 MDA.005uCi 35 59c3 and d iii report leakers 35 59e iv follow instructions 35 400; 35 500
~
v.
quarterly inventory 35 598 vi don'_t open Co260 cells deleted; not allowed by 8
instructions vii-count sources and survey implant patients 35 404a 1
3514b6 -if for diagnostic procedure other than in 35100b and 35 200b; labeling, comply with chemical, physical chemical deleted because form, route, dosage it would be a new,-
unlisted pharmaceutical c allows in-vitro general license without must request on new filing NRC-483 application application form
.d may receive; sources for calibration and reference 35 58; sealed sources only; 6 mci el leak test 35 59b exceptions 35 59f 2 MDA.005uCi 35 59c 3 report leakers 35 59e fl follow instructions 35 59a 2 quarterly inventory 35 59g 35 21 ' Teletherapy full calibration a when 35.632a b what 35 632b c how 35.632d d decay each month 35.632e qualifibd expert 35 632f e
35 22 Teletherapy spoc checks a each month 35.633a b what 35.633b c qualified expert 35.633d and e 35 23 calibrate instruments a' full calibration 35.630a b spot check 35 630b 35 24_ qualified expert a certified 35 961a b T&E 35 961b; changed c footnote 35 29 35 25 Records a full calibration and instruments 35.630c and 35.632g b spct check and instruments 35.630c and 35.633j c qualified expert T&E 35 33bsii 35 31 General License deleted; pharmaceuticals into 35100a t
- 35 41 Definitions of, misadministration 35 15 35 42 Reports of therapy misadministration 35 37a and b i
35 43 Reports of diagnostic misadministration 35 37c 35 44 Records of all misadministrations 35 37d 35 45 Rights and duties of licensees 35 45e 35.100 Groups of medical uses a Group I 35100a; I-125 as oleic acid and sodium iothal-amate deleted b Group II 35 200a; Hg-203 as chlor-merodrin deleted c Group III 35 200a; added generators for extraction, Tc-99m as' disofenin or succimer d Group IV 35 300a e Group V 35 300a
.f-Group VI 35 400 and 35 500; added iridium and tantalum as wire R
United States Pharmacopeia XXp765 recommends 35 204
.15uci99Mo/mCiTc-99m FRN February 9,1979 Policy Statement Followed 1.
Continue to regulate for radiation safety of workers and public 2.
Regulate safety of patients where justified by risk to patient and voluntary compliance is inadequate 3
Minimize intrusion into medical judgment FCMS ltr May 3, 1979 Approved suppliers 35 49 FCMS ltr June 4,1981 Decay in storage 35 92 OSD ltr August 4, 1980 Mo-99 breakthrough 35 204 IE bulletin September 15, 1980 Teletherapy timer accuracy 35.632b4 and 5 FRN December 2, 1982 AU T&E Subpart J FRN May 27, 1982 Regionalization 35 16 FRN September 13, 1982 Radiation Safety Committee 35 31 at institutions FRN January 18, 1983 Teletherapy room monitor and 35.621, 35.645 inspection and servicing NMSS May 10, 1979 checklist "Information to be submitted for a Mobile Nuclear Medicine License" 3
Client management authorization 35 35b 5
Check of transported instruments 35 80d 6.
Closecut survey 35.80e; deleted wipe test 7
Secure the material 35 80c FRN September 1,1981 Measurement of dosage 35 53 IE ltr April 16, 1979 Syringe and vial shields 35.60, 35 61
~
AAPM petition docketed November 13, 1981 para 1 35 630a1 para 2 35.630a2 para 3 deleted; check sources may indicate need for calibra-tion when no't needed para 4 35 630 Meeting J anuary 21, 1982 re AAPM petition (Rodenbeck) several experts said intercomparison is a good check 3
Code of practice for x-ray therapy linear accelerators (Medical Physics v2 n3 pl10, May 1975)
IIB reserve one dosimeter to use as primary local standard 35.632c IIIA safety' survey 35 642a IIIB2 head survey
-35.641al IIIC area survey 35.641a2 IVC coincidenceofphoton/lightfield 35.632b2 IVG verification of beam flatness 35 632b3 VII routine checks 35.633 ANSI N449-1974 Guidelines for Maintaining Cobalt-60...
Teletherapy equipment 3 General considerations (training of service personnel) 35.645b 4.1.1' Source condition indicator check 35 633g3 4 1.2 Door interlock 35.633gl 414 Source surface distance 35 633b4 415 Spot check and full calibration 35 632, 35 633 4.1.6 Timer 35.632b4 and 5, 35.633bl and 2 417 Congruence of light and radiation field 35.632b2 and 35 633b3 4 1.11 Beam orientation interlocks 35.633g2 4.1.12 Central axis indicators 35.632b6 and 35.633b4 4.1.14 Source leakage 35 59e; reduced to.005uCi 4.1.19 Source housing leakage 35.641al ANSI N449 1-1978 Procedures for periodic inspection consulted ANSI N42.13-1978 Calibration and Usage of Dose Cakibrator Ionization Chambers 4.2.1 Geometry 35 50a4 4.2.2 Activity ranges 35 50a3 451 Reference, source chqcks 35 50a1 35 50a3 452 Linearity check 455 Frequency of calibration 35 50a and b 4.6.1 Accuracy 35 50c 4.6.3 Corrective action 35 50c ANSI N323-1978 Radiation protection instrumentation test and calibration 4 2.2.1 Accuracy 35 51c 4'.5' Records 35 51e 471 Primary calibration frequency 35 51a 4 7 3-Performance test frequency 35 51d ilegulatory Guide 8.18 ALARA at medical institutions general guidance; not incorporated Material Licensing Branch Standard Conditions Sept.1979 SLC-lO leak test 35 59 4
SLC-52 count and survey implant patients 35 404 i
SLC-53 30 mci felease limit 35 75 SLC visiting physician 35 345 added AgState AU's SLC-63 Ma-99 contamination 35 204 l
SLC64 Teletherapy servicing restriction 35.605 l
SLC-65. Patient observation 35.622 1
i SLC-66 Leak testing for teletherapy 35 59; reduced to.005uCi SLC,68 Emergency instructions for users 35.610 SLC-69 Teletherapy room interlocks 35.620, 35.633g l
4
r=
e SLC-70 Teletherapy surveys 35.641; 35.642 SLC-71 No changes in teletherapy facility 35.606 SLC-72 Inspection and servicing 35.645 SLC-94 Teletherapy room monitor 35.621 SLC-95 Decay in Storage 35 92 Draft Regulatory Guide for teletherapy March 1982 414 Facilities and equipment 35 604 5.
Amendments 3517 and 35.606
-A Medical Isotope _Sommittee 35 31 and 35 32 B AU T&E 35 960 D Calibration of Instruments 35 51 F Teletherapy Survey Reports 35.641 and 35 642 G Operating and Emergency Procedures 35 33, 35.610, 35.633, i
35 59 H Instruction of Personnel 35 33 I_ ALARA Program 35 30 Je 4==ndments 3517 and 35.606 Regulatory Guide 10.8 Medical Programs October 1980 4.4 footnote Supervision 35 38
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35 2 47 Medical Isotopes Committee 35 31; 35 33 4.8 Training and Experience Subpart J 49 Instrumentation 35 50; 35 51 4 11 Xenon 35 90; 35 205 4.12 Personnel Training 35 33 4 13 Ordering and Receiving Material 35 33 4.14 Opening Packages 35 33 4.15 General Rules 35 33 4.16 Emergency Procedures 35 33; 35 610 4 17 Area Survey Procedures 35 70 4 19 Pharmaceutical Therapy 35 304 4.20 Sealed Source Therapy 35 405 4.21 Gases and Aerosols 35 90; 35 205-4 26 Signature 35 16 5.
Amendments 35 17; 35 606 A (FRN December 2,1982) T&E Subpart J B Me41 cal Isotopes Committee 35 31; 35 33-D Survey Meters 35 51 D Dose Calibiator 35 50 E Procedures for Ordering 35 33 G. General Rules 35 33 H Emerge'ncy Procedures -
35 33 I Arek Survey Procedures 35 33; 35 70 J Waste Disposal 35 33; 35 92 K Pharmaceutical Therapy 35 33; 35 304 L Sealed Source Therapy 35 33; 35 304 M Gases 35 90; 35 205 N Amendments 35 17 0 ALARA 35 30 i-5
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1983 Medical
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seao 62386 Month No. of' Applications Reev'd New Licenses Other Amend.
Renewals Terminations January 193 13 136 39 5
February 220 6
166 44 4
Phrch 251 13 177 56 5
. April 220 12 136 66 6
May 225 6
140 74 5
Juna 213 7
141 61 4
. July 210 17 135 53 5
August 223 7
147 59 10 aptember 240 18 147 66 9
'tober 207 10 147 45 5
Novrmber 210 15 148 35 12 Dectmber 223 19 152 49 3
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' Analysis of Compliance Cost for Part 35 (9-23-82 draft)
General Notes:
Section: describes where the requirement is defined DEFGHI: describes which class of licensee must comply; cf Subparts D through I in proposed Part 35; M refers to mobile service Required / Option: R denotes a requirement; O denotes a privelege (with concomitant burdens if the privelege is exercised) contained in proposed Part 35 Frequency: 5-5 years; a-annually; cont-continuously; d-daily (250 days per year);
w-weekly (52 weeks per year); m-monthly; g-quarterly; bi-e-biennially; bi-a-biannually; /adm-per administration Recordkeeping: an estimate of hours spent generating records, reports, logs; cost of paper, forms, filing space are considered trivial and are not included Equipment and supplies:
an estimate of cost of capital equipment and consumable supplies needed; unless indicated otherwise, capital equipment is amortized over 5 years Contract cost: an estimate of the fee charged for a service by an outside V
contractor; based on informal surveys
'$/yr: total cost of compliance per year New or RG, LC, Reg: N-a new requirement imposed by the proposed Part 35 RG-a recommended procedure, contained in a regulatory guide, that is frequently adopted by applicants LC-a frequently imposed license condition, I&E order, or licensing branch policy R-a current regulation Note: RG, LC, and R imply similar, not verbatim, procedures or requirements The final column is an abbreviation of the section title.
After the cost of complying with each individual section has been determined, six model licensees that are representative of the medical industry are described.
For each of the six model licensees, the total regulatory compliance cost is estimated by adding up the cost of each section with which the model licensee would have to comply. Compliance costs for the six model licensees appear on the last page.
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Footnotes 1 Assume $60/ hour (ef $58 37/ hour in Enc 13 p 9)
-2 Assume $20/ hour (cf $18 37/ hour in Enc 13 p 9) 3 Filing fee required in Part 170 4 Assume one each two years based on current amendment load of 1303 requests in 1981 from an industry with 2631 licensees 5 Formal written ALARA program only required for institutions; cost of drafting the program is included in cost of preparing application 6 Radiation Safety Committee is only required at institutions; assume five members meeting for one hour 7 Assume about four investigations each year 8 Development of procedure is included in preparation of application 9 Required by Part 19; included in proposed Part 35 for clarity and completeness 10 Currently submitted for reviet by NRC i l 11 Cost of filing is considered trivial my a %
12 Based on 15 studies /da (Encl 3 p 9) x 250 days / year x.01%
.375/ year 13 Instruction and supervision are required by Part 19; included in proposed Part 35 for clarity and completeness 14 200 uCi Cs-137 calibrated source cost from APC Cat No 45 p 19*
15 Assume one instrument; mst licensees contract this work to a consultant 16 Based on 15 studies / day x 250 days / year - 3750 adm/ year; dose calibrator cost is $1750 from APC Cat No 45 p 61*
18 Calibrated check sources @ $75 each; NEN Cat Nov 1980 p 10 19 The cost of additional recordkeeping required in case of a leaking source
,m has not been added because they are very rare
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20 GM meter + detector + check source; APC Cat No 45 p 56*
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21 NIH model from APC Cat No 45 p 9*
22 s5 vial shields @ $90 from APC Cat No 45 p 90*
23 3750 labels / year @ $10/500 from APC Cat No 45 p 11*
24 Supplied by manufacturer gratis 25 Assume two clients per day, 250 days per year 26 Almost all hospitals have fume hoods installed in all laboratory areas 27 Xenon administration and trapping system from APC Cat No 45 p 22*
28 Assume one patient per month 29 Install one switch and run cable to console; guesstimate 30 Cost for monitor, battery pack, and check source from APC Cat No 45 p 109+
31 Suspended mirror; guesstimate 32 Victoreen condenser R-meter model 570 $1500, model 621 chamber $475, model 74-374 water phantom $500, $2475 + 5 - $495; NBS calibration $400, 2-4 calibrations in five years, $1000 + 5 - $200; Victoreen quotes by phone 11-23-82, calibration cost effective November 1981 33 Assumetwodays@$100/ hour 34 Cost of training professional staff has not been considered because these individuals would need this training for JCAH review and to avoid malpractice suits 35 Group H (diagnostic devices) receives about four new sources each year; Group I (teletherapy) receives one source each five years 36 Assume one patient r month; for each patient two additional days in a private room @ $500 day h)
- APC Cat No 45: Atomic Products Corporation, catalogue was received from
/
supplier October 1982
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Model Licensees 1 Nuclear medicine diagnostic clinic not based in a hospital,15 studies / day, 250 days / year 2-Nuclear medicine diagnostic clinic based in a hospital,15 studies / day, 250 days / year 3 Case 2 plus twelve radiopharmaceutical therapies each year 4 Mobile service not bwed in a hospital, 7 5 studies per day are conducted at two. client locations, 250 days / year,eno xenon studies 5 Teletherapy based in a hospital that also has a nuclear medicine diagnostic clinic 6 Brachytherapy based in a hospital that also has a nuclear medicine diagnostic Oi clinic, assume one brachytherapy patient each month b
Model Licensees
&dion 1
2 3
4 5
6 35 2 318 318 318 580 35 17 60 60 60
-60 35 18 20 20 20 20 35 31a2 1200 35 31a4 80 35 32 480 480 480 35 33b1 1000 1000 1000 35 37 70 70 70 l
35 50 137 137 137 35 50 41 41 41.
35 50 80 80 80 35 50 8
8 8
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35 51~-
75 75 75:
35 53 1850 1850 925 35 59b 55 55 55 95 35 59gh 109 109 109 109 35.60 26 26 26 1
35 61 90 90 90 35.62 75 75
,J 38 35 70ab 1000 1000 500 35 70c 208 20 8 104 35 75 12000 35 80e 2000 35 92 144 144
.144
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35 204 200 200 200 N
35 205 400 400 35 404
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48 35 610 8
35.620 40 35 621 219 35.622 40 35.630 695 35 632 960 35 633a 720 35 633r 120 35.641a1 12 35.641a2 96 35.642 2
35 644 16 35.645 320 l
subtotal 12000 3908 252 2
. carryover 7726 7726 7726 total cost
$6446
$7726
$19726
$6480
$11634
$7978 total of entries in this colunn regulatory costs associated with having just a nuclear medicine imaging clinic
4A 73-/
9D March 10,1983
/3, Dobbio, r*ll:
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ro doso en1hator, A!G/I N42.13-1978 "... Calibration and usage of dose calibrator..." is the latost odition available as of today (I called their sales departent).
ro Vacca item 4 1.
S 4 3 says " Suitable standard scureos...shall be used for routino calibration..."; it makes no cention of the suitable activity of those sources.
2.
S 4 51 augmats use cf 100 to 200 uci 137cs and 1 to 5 cci 5700 for " regular testing" (road " daily check"). The S would require a cheek on each. cork shift.
3 S 4.6.1 says, for a scurce hotter than 100 uCi, the instrue nt should be accurate within 10%. " Accuracy of ceasurecents...bolow 100 uCi may not fall within the $10% limits and should be determined for each instruent..." This 3 recognizes that the instrument may not parform well below 100 uC1. The S does not require the use of a 100 u0i source for the accuracy test. Mia x xam1= x"=
tTyrimorTYnwvxxTunTnxTrnyvxmmmarnnF/ If the instrucent is accurate below 100 uCi and is linear over the range of uso (cost do and are, at least overy one I have scen), there is no casssuremnt problem.
L.
3 6.2 recognicos that non-linear:ty p:cblems may be encounterad above 100 uC1. A discussion of non-linearity below 100 uCi is conspicuous in its abcence.
5 I think the coupling of the limerity test in G 35 93 vith the accuracy tect theroin is sufficient to show accurato masurecents.
6.
I think the cocmonter has misinterpretted the standard.
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION
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M t-NOTE FOR:
Jim Lieberman, ELD A
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. FROM:
John Klucsik, ELD j
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SUBJECT:
REGUIATION AND CENSING OF TECHNOLOGISTS IN W:-
NUCLEAR MEDICINE E.
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In our recent phone conversation we discussed portions of
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the proposed Part 35 which deal with the act'ivities of unlicensed medical technologists and the supervising' physicians who would be identified on a hospital license.
I understand your concern to be over the proposed rule's-recognition of the technologist's activities and the imposition of regulatory requirements upon the technologist and the authorized (physician) user of byproduct material,
, rather than.upon the (hospital) licensee.
Proposed section 35.2(a) includes the standard prohibition against handling material except in accordance with a license.
If nothing further were said, several choices would be available 1.
The unlicensed technologist could be precluded from handling material; N3 2.
Each license could expressly authorize material-
.44 handling by identified technologists;
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Each license could be interpreted to authorize or could fil expressly authorize material-handling by any agent of
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the licensee;
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The regulations could expre ssly authorize
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material-handling by any agent of the licensee; or
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The segulations could exp2.essly authorize MR m=
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(physician) user under his supervision.
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Q-Option 5 is the approach embodied in the proposed revision E:6 of Part 35.
I understand option 3 to be the one you favor.
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September 16, 1982
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Option 1 would disrupt the delivery of nuclear medicine pi services.
Option 2 would be administratively cumbersome and
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as a practical matter would not work (although this is the 1_.
system which.is and would continue to be used for l
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physicians).
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Optio'ns 3 and.4 tould follow the model used in reactor
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licensing.
The licensee would be responsible for the acts
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of his agents.m This approach will work in the medical.
setting if.the agency relationships there are the same as
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Often they are not.
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t, Frequently, the hospital is the licensee.
Physicians who
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are not on the hospital staff (are not agents of the licensee) may have practice privileges at th'e hospital and may be identified on the hospital's license as persons i
authorized to_ perform nuclear medicine procedures there.
1 The technologist may be on the hospital staff but will take direction from the independent physician.
(The technologist may be a borrowed servant when carrying out the independent physician's orders).
Options 3 an'd 4 would place civil liability upon the licensee hospital for actions of its borrowed servant, taken
. under the direction of a physician who was performing no service for the hospital and whom the hospital could control only by denial of his practice privileges.
The principal drafters of the proposed revision of Part 35 believe that fixing liability upon a licensee who may have little practical control over how byproduct material is (fC'".-
A administered to' patients will not result in the desired patient and worker safety regardless of the level of 61--
enforcement activity or the magnitude of the penalty
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imposed..
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y I believe that relying on an agency. relationship between the L5 M-.
violator and the licensee may present substantial a@q fp -
evidentiary' problems.
One would have to establish the
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agency relationship between the licensee hospital and the
,77 authorized user physician (which may not exist); and between i4 m;..t the licensee hospital and the technologist (which may not 1-Ft A..
exist.if the technologist is a borrowed servant or if the
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These problems are compounded if the licensee is M
such?_an independant service.
Such a service would have jg...,
absolutely no control over the authorized user (physician) g ;
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regardless of whether he was on hospital staff or was an Ip W.'
independent practitioner.
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Op 16h 5 av' ids at least some of these problems by placing o
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1pability at the point of control.
The authorized user
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September 16, 1982 '
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directs the technologist when the technologist is is,
administering material.
(See S 35.38).
Where the licensee W
is more likely to have direct control, the duty of Ql compliance is upon the licensee (see SS 35.53, 35.70).
"30 y
I understand you to have some reluctance to impose civil
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You have noted J.:-
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that radiographers are in a similar position and that we g,'. ~
' there impose the penalty upon the licensee employer or
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principal.
There are two differences.
One is in.the agency
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relationship discussed above.
The other is in the effect of 6.
noncompliance.
A radiographer's noncompliance may result in
'3 overexposure of. himself~ and a piece of pipe.' A medical technologist's or authorized user's noncompliance may result in overexposure of himself and the patient.
The prihcipal drafters believe it appropriate to place liability squarely upon those who have direct control over administration of material to patients.
You should note that the duties f
placed directly upon authorized user physicians and supervised technologists relate only to the actual administration of material to patients.
See SS 35.200, l
35.300, 35.400, 35.500.
Other duties relating to surveys, calibrations,.etc., are generally imposed upon the licensee.
After you have had a chance to review the attached portions of the proposed Part 35, please give Bill Walker, FCML, a call to schedule a conference among the three of us, Led Higgenbotham, IE, and members of Bill's task force as appropriate.
Bill can be reached at X-74232.
Atitachment:
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Portions of Proposed
- M Part.,35
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W. Walker, FCML Nr 1-%.-
N. McElroy, ORPBR N
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L. Higgenbotham, IE
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T. Dorian, ELD
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