ML20202D159
| ML20202D159 | |
| Person / Time | |
|---|---|
| Issue date: | 05/16/1972 |
| From: | Mccool W NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| SECY-R-460, SECY-R-460-R, NUDOCS 9902010321 | |
| Download: ML20202D159 (11) | |
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SECY-R 460
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pol' ICY SESSION ITEM DETROIT OSTEOPATHIC HOSPITAL CORPORATION- AEC LICENSE NO.
21-04062-01-MIS ADMINISTRATION OF A RAD 10 PHARMACEUTIC AL TO A PATIENT Note by the Secretary Tle Director of Regulation has requested his attached memorandum of May 15, 1972, with enclosure, be circulated for consideration at the Policy Session on Thursday, May 18, 1972 and has provided the following digest:
The Acting Director of Regulatory Operations plans to sign the attached letter to the Detroit Osteopathic Hospital Corporation (AEC license !:o. 21-04082-01).
This case involves the misadministration of a radio-pharmaceutical to a patient who died one month after receiving the treatment and the AEC staff has concluded there is a high probability that the radiation dose resulting from the misadministration was lethal. Among l other things, the letter requests the licensee to infonn the patient's family of our conclusion. The letter, i and a copy of our investigation findings attached thereto, will be placed in the Public Document Room when the reply is received from the licensee.
W. B. McCool l Secretary of the Commission NO. OF 140. OF DISTRIBUTION COPIES DISTRIBUTION CO PIES _
Secretary 6 Inspection 1 Chairman Schlesinger . 1 Off.of Planning & Analysis 2 Commissioner Ramey s Asst. GM for Admin. 1 Commissioner Johnson 2 Asst. GM for Research 1
ommi ssioner Larson 9 Biology and 14edicine 1 !
Commissioner Doub 2 Director of Regulation 1 General Manger 1 Deputy Dir. of Regulation 1 Deputy Gen. M r. 1 Dir., Off, of Adsin. 3 Exec . Asst. to GM 2 Dir., 0 10ay,!t &iaison 1 General Counsel 4 D f- Rbg.' Ope ra t ions 1 Cont rolle r Information Servic
} {3 of Reg.Standands ty Dir.for Fu is & Mat.
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SECY-R 460
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POL _ ICY SESSION ITEM DETROIT OSTEOPATHIC HOSPITAL CORPORATION- AEC LICENSE NO.
21-04062-01-MISADMINISTRATION OF A RAD 10 PHARMACEUTIC AL TO A PATIENT Note by the Secretary l tie Director of Regulation has requested his attached memorandum i of May 15, 1972, with enclosure, be circulated for consideration at the Policy Session on Thursday, May 18, 1972 and has provided the following digest:
The Acting Director of Regulatory Operations plans to sign the attached letter to the Detroit Osteopathic Hospital Corporation ( AEC license !!o. 21-04082-01).
This case involves the misadministration of a radio-pharmaceutical to a patient who died one month after ;
receiving the treatment and the AEC staff has concluded l there is a high probability that the radiation done .
resulting from the misadministration was lethal. Among l other things, the letter requests the licensee to inform the patient's family of our conclusion. The letter, and a copy of our investigation findings attached thereto, will be placed in the Public Document Room when the reply is received from the licensee.
W. B. McCool Secretary of the Commission fl0. OF 110. OF DISTRIBUTION COPIES DISTRIBUTIOli COPIES Sec retary 6 Inspection 1 Chairman Schlesinger '
off.of Planning & Analysis 2 Commissioner Ramey Asst. GM for Admin. 1 Commissioner Johnson 2 Asst. GM for Research 1
ommi .a s t one r La rs on 9 Biology and Medicine 1 Commissioner Doub 2 Director of Regulation 1 General Man er 1 Deputy Dir. of Re ulation 1 Deputy Gen. r. 1 Dir., Off. of Ada n. 3 Exec . As s t . to GM 2 Dir., 0 S.0c5r,8. t &iaison 1 General Counsel 4 D inf- Rb g.' rations 1 Cont rolle r . of Reg. andards 1 Infonnation Servic } y Dir.for Fu ls & Mat. 1
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OFFICIAL USE ONLY M 9902010321 720516 PDR SECY R-460 R PDR
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- UNITED STATES i ,,}. ATOMIC ENERGY COMMISSION l l WASHINGTON. D.C. 2054 1, .. IE W i 5 W2 Chaiman Schlecinger l Cocniscioner Bamey Cocaniosioner Johnson Cocnissioner Larson Comissioner Doub DETROIT OSTEOPATHIC HOSPITAL CORPORATION AEC LICENSE No. 21-0!+082-01 MISADMINIS7.BATION OF A PADIOPRARMACElfrICAL TO A PATIE!TI The Acting Director of Regulatory Operations plans to aign the ottsched letter to the subject hospital. This case involves the clicadminictration of a radiophamaccutical to a patient who died one cionth af ter receivira the treatment. Based on infomation obtained during our investigation und subocquent evaluation of this infomation, ve have concluded that there is a high probability that the radiation dose resulting from the misadministration van a lethal dose.
Tne issuance of the attached letter conetituten a significant change from the manner in which cases like this have been handled in the past in that our investigation findings and conclusions with respect to the micad=inistration (i.e., o lethal dose) vill be placed in the Public Document Room. Specifically, I understand that in the past such findir.cn nnd conclusionc vere not placed in the Public Document Room becauce necurrer.ces of thic type vere not considered reportable, nor verc :hty considered violations of AEC rulco and regulations. Reconsideriry: thi:;
policy in li ht J of the specific findin6s in thic cace, vc believe it it:
in the public interest to make results of our investication available to the public.
It should be r.oted that GAO, in their recent review of Regulatory in::pce-tion and licensing functions, has recommended that medical licensees be required to report all misudministrationc of radioactive materials to patientc. Appropriate cections of the rules and current practices in our licencin6 Procedures in this arco are presently under study.
Folloving our invectication of the above occurrence, ve cor. ducted c cor. .rchensive and thorough inspection of all activitics thic corporotice.
conducts at its three hospitals under AEC license. Seven items of
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noncompliance vere found of which .sne vere particularly significant.
Four of the items related to records and posting.
I would like to discuss this matter with the Commiss on at on corly date.
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. Js s L. Hanning Muntzi .
Director of Regulation
Enclosure:
As Stated
Contact:
Gen W. Roy - X7347 R. H. Engelken - X7356
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%, 7 21-04082-01, S Ralph F. Lindberg, D. O.
Executive Vice President Detroit Osteopathic Hospital Corporation 21700 Creenfield Road Oak Park, Michigan 48237 .
Dear Sir:
This refers to the investigation of the activities of Detroit Osteopathic Hospital Corporation (D0 llc) under AEC License No. 21-04082-01 which was conducted by Mr. G. A. Phillip and others of our Regional Office, Glen Ellyn, Illiaois, during the period March 30 through April 19, 1972.
Specifically, the investigatien concerned the administration to a patient of 30 mil 11 curies of phosphorus 32 as sodium phosphate instead of col-loidal chromic phosphate as intended. This occurrence was reported to AEC by Dolic by eclephone on March 29, 1972. This letter also refers to the subsequent inspection condreted by Mr. E. C. Ashley of our Regional Office from April 17 through 20, 1972, of the activities of DOHC under License Nos. 21-04082-01 and 21-04082-03, and to the discussion of our findings held with you, Arthur E. Levine, D.O., and Mr. Ross V. Bunting at the conclusion of the inspection.
Based on our investigation findings, a copy of which is enclosed as Appendix A, we have reached the following conclusions with respect to the intraperitoneal administration of 30 mil 11 curies of phosphorus 32 as sodium phosphate to a patient on January 12, 1972:
Considering (i) the calculated dose in rads to the bone marrow to be in the range of 585 to 655, (ii) the radiosensitivity of the bone marrow to increase the effect of the dose, and (iii) the protraction of the dose over 30 days with its tendency to decrease the effect of the dose; there is a high probability that the dose would be lethal. The patient's symp-coms and blood data at the time of death were terminal conditions compatible with acute bone marrow damage which would be observed 30 days after such an administration.
CdRTIFIc'D MAIL RETURN RECEIPT REOUdSTED
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Detroit Ostcopathic j, Hoapital Corporation Uc believe that the patient's family should be informed of the facts concerning this administration and of AEC's conclusions. You are hereby requested to confirm, by letter to this office within twenty (20) days of your receipt of this letter, that the family has bean informed. Also, since this 1cteer will be made a matter of public record upon our receipt of your reply, you may wish to consider making a public announcement.
Uc understand that as a result of a meeting of the DOHC Isotope Committee on March 29, 1972, the Corporation removed the physician involved from all further therapies with phosphorus 32. We a;so understand that DOHC subsc-quently suspended the physician from any further diagnostic or therapeutic .
uses of radioisotopes at DOHC hospitals and has removed the Nuclear Medicine Technologist from all further duties involving the administration 4
of racioisotopes to patients. We have amended AdC License No. 21-04032-01, i deleting the physician's name from the license. That license amendment is I
enclosed herewith as Appendix B. The Ccamission has found that the public interest requires that the /.mondment bo immediately effective. You may, pursuant to 62.204 of 10 CFR Part 2, request a hearing with respect to the Amendment within twenty (20) days af ter receipt of this letter.
The April 17-20, 1972 inspection was an examinstion of the activitics conducted under your licenses as they relate to radiation safety and to compliance with the Commission's rules and regulations and conditions of your licenses. The inspection consisted of examinations of pertinent procedures and records for the period from January 1.1970 through March 31,1972, interviews with personnel, measurements by the inspector, and observations by the inspector.
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3ased on the results of the inspection, it appears that certain of your activities were not conducted in full compliance with conditions of your Lict:nse Nov . 21-04062-01 and 21-04062-03 and the requirements of the A4C's
" Standards for Protection Against Radiation," Parr 20, " Rules of Cencral applicability to Licensing of Byproduct Material," Part 30, and " Human Uses of Byproduct Material," Part 35, Title 10, Code of Federal Regula-tions, as set forth in the enclosed Appendix C. The items designated in the Appendix as Nos. 5 and 7 are similar to those found during the pre-vious inspection and brought to your attention in our letter dated November 7, 1966.
{ Lith respect to the inspection and Appendix C cnclused herewith, this
- ictter constitutes a Notice of Violation. This notice is sent to you purs uant to the provisions of Section 2.201 of the AEC's " Rules of I
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Detroit Osteopathic Hospital Corporation Practice," Part 2, Title 10, Code of Federal Regulations. Section 2.201 requires you to submit to this office within twenty (20) days of your receipt of this notice, a written statement or explanation
, in reply including: (1) corrective steps which have been taken by you,
. and the renults achieved; (2) corrective steps which vill be taken to
-jl avoid further violations; and (3) the date when f all compliance vill i be achieved.
The findings of the investigation and subsequent sospection indicate a need for DOHC to strengthen its management controit concerning the ad-ministration of radioisotopes to patients. Accordingly, you are hereby requested to include in your reply to this letter a description of the steps taken or planned by DOHC to prevent further erroneous administra-tion of radioisotopes to patients and to assure compliance with AEC requirements.
We plan to conduct unannounced inspections to ascertain whether appro-priate management action has been taken to assure an adequate level of safety of operations. Our inspection findings and your reply to this letter will provide a basis for us to determine whether any further enforcement action vill be tdcen by this office.
Very truly yours, Lawrence D. Low Acting Director of Regulatory Operations
Enclosures:
- 1. Appendix A - Investigation Findings
- 2. Appendix B - Ldcense /.mendment
- 3. Appendix C - Itema of Noncompliance
- 4. 10 CFR Part 2 6-
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l APP 2NDIX A INVESTICl. TION FINDINGS i on March 29, 1972, the Detroit Osteopathic' Hospital .voration, k Detroit, Michigan, an AEC licensee, informed the ~ by tc1cphone that on January 12, 1972, a patient who was schedu'.a to receive a 30 milli- .
curie intracavitary dose of radioactive phosphorus 32 (P-32) in the form of colloidal chromic phosphate had been administered 30 millicuries of soluble sodium phosphate P-32. The patient had died 30 days after the administration of the radioactive material.
l An AEC investigation of this matter was conducted during the period March 30 through April 19, 1972, with the assistance of an AdC medical i consultant. A representative of the State of Michigan Department of l I
Health accompanied the N C investigators. During the investigation it was ascertained that the patient had been admitted to a hospital oper- l ated by the licensee on December 29, 1971, f or evaluation of a large abdominsi mass. On January 3,1972, the patient was explored by a surgeon who removed a large ovarian cyst, with socio spillage of fluid l from the cyst into the abdominal cavity. According to the surgeon, no cbvious stans of ictra-abdominal metastasis were noted at that time.
Subsequently, the pathological diagnosis of the cyst was mucinous
- cystadenocarcinoma of the lef t ovary.
Following receipt of the pathological report of malignancy, the sur- j geen conferrad with the licensec's Chief of tha Nucicar Medicine Department and with the Oncology Department. The decision was made to administer 30 millicuries of radioactive colloidal chromic phosphate P-32 intraperitoneally to destroy any cancer cells that might have been present in the spilled fluid from the cyst to prevent sceding in the peritoncum and metastasis. A written requisition from the surgeon for "P-32 therapy" vas sent to a physician at the hospital, uho is authorized by the hospital's AEC license to perform such an i I
administration. Based on the written requisition and on oral instruc-tions from the physician, the Nuc1 car Medicine Technologist placed an order with a radiopharmaceutieni supplier by telephone for 30 milli-curies of P-32. t!o record of the telephone order was made at the hospital and the technoloS i st only recalled specifying " intracavitary )
P-32." The order was recorded by the order taker at the radio- l l
pharmaceutical supplier as 30 mil 11 curies of "P-32 Sod Phos IV," but the order taker had no specific reco11cetion concerning that particular phone order. .
On January 12, 1972, the hospital received a package properly labeled as sodium phosphate P-32, injection, for intravenous administration, total activity 30 mil 11 curies as of January 12, 1972, volume 31.50 milliliters. The innar container, a glass vial, bore two labels identical to that appearing on the outer container. The technician received the shipment, opened the outer contatter, removed the extra label f rom the bottle and placed it in the material receipt and use record book.
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- i Appendix A -
i On the samn dr- che physician withdrew the solution from the bottle into a 30-m'iiiliter syringe, proceeded to the patient's room and ad-( ministered the material into the patient's peritoneal cavity. Neither the technician nor the administering physician recognized that the P-32 administered was not in the desired chemical form for this use.
NOTE: This volume of solution is five or six times greater than the volume of chromic phosphate normally used in an intracavitary adminictration. Sodium phosphate solution is colorless or alpale yellow, l vhereas colloidal chromic phosphate is foggy or turbid and is blue-gray or green.
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The patient was discharged from the hospital on January 14 in apparent good condition. The patient subsequently was seen by the surgeon in his private officca on two occasions. On the first occasion, about two weeks af ter discharge, the patient complained of general malaise which the surgeon attributed to post-operative depression, possibly some effect of P-32 therapy, and anxiety from the knowledge that further surgery to scrape the pelvic area was planned. During the second visit, the patient appeared to be moribund, was experiencing some rectal bleeding and was jaundiced. The patient was immediately readmitted to the hospital by the surgeon on February 10 and died on February 11. The surgeon requested permission to have an autopsy performed, but was refused by the patient's family. The surgeon re-corded the cause of death as respiratory failure with renal failure, carcinematosis and mu,cinous cystadenocarcinoma of the left ovary.
On March 10, 1972, the licensce's radiation physicist, during a routine review of the hospital's radioactive material roccipt and use records, observed the 30-millicurie sodium phosphate label and the log entry indicating the administration to a patient as a singic dose. Through subsequent discussions between the radiation physicist, che adininistering physician, and the Chief of the Nuc1 car !!edicine Departmont, it was realized the patient had received an intracavitary dose of sodium phosphate instead of the intended chromic phosphate, and the decision was made to suspend the administering physician from further isotope administrations and to inform the t.2C.
The resultant radiation dose to the patient's bonc compartment, in-cluding spleen and liver, was calculated by the licensee to be about 625 rads. AEC calculations indicate the dose to be in the range of 585 to 655 rade. ,
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" L. ATOMIC ENERGY COMMISSION
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"*" BYPRODUCT MATERIAL LICENSE Supplementary Sheet i 21 04032-01 1 License Number Amendment No. 32 Dotroit Osteopathic !!ospital Corporation 12523 Third Avenue HiGhland Park, Michtsan 48203 ,
Liecnco Number' 21-04032-01 is amended as follows:
Condition 10. is amended to road:
- 10. Oyproduce material chall be used by, or under tho supervision of, Arthur E. Levino, D.O. . Byproduct material, except Iodino 131 for :
treatment of thyroid carcinoma, may also bo used by, or under the supervision of, S. H. Roberto, D.O., or Thomas Griffith, D.O.
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4 DETROIT OSTEOPATHIC HOSPITAL CO3PORATION_
APPENDIX C INSPECTION CONDUCTED APRIL 17 - 20, 1972 i
License No. 21-04082-01_
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- 1. 10 CTR 35.2, "1deense requirements," states, "No person shall re-ceive, possess, use, or transfer byproduct material for any human use except in accordance with a specific or general license issuco pursuant to the regulations in this part and Parts 30 and 32 or 33 --
of this chapter."
Condition No. 9(A) of this license authorizes the husan use of -
byproduct material only for those diagnostic procedures listed in Section 35.100,10 CFR 35. Condition Nos. 9(B) through 9(0) authorize the use of byproduct material for additional specifi-cally designated procedures. _
Contrary to the above, a, technetium 99m pertechnetate was used on at least 14 occasions during the period January 1,1970 through March 31,1972 for kidney flow studies;
- b. technetium 99m pertechnetate was used on at least 7 occasions during the period January 1,1970 through March 31, 1972, for placenta localization studies; and
- c. iodine 131 as iodinated human serum albumin was used on at least 10 occasions during the period January 1,1970, through March 31,1972, for placenta localization studies.
- 2. 10 CFR 30.51, " Records," requires that each person who received byproduct material pursuant to a license issued pursuant to the regulations in this part and Parts 31-36 shall keep records showing, among other things, the disposal of such byproduct material.
Contrary to the above, no records were maintained showing the dis-position of 30 mil 11 curies of phosphorus 32 as colloidal chromic phosphate received in January 1971 at Riverside Hospital, Trenton, Michigan.
- 3. 10 CFR 20.203(b), " Caution signs, labels, signals , and controls ,"
requires that each radiation area be conspicuously posted with a sign or signs bearing the radiation caution symbol and the words:
" Caution - Radiation Area."
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Appendix C Contrary to the above, the area in which a nominal ." millicurie molybdenum 99-technetium 99m generator was used ar.. stored at ths Detroit Osteopathic Hospital was not posted as required. During the inspection the inspector measured radiation levels of up to 10 milliroentgens per hour at eighteen inches from this generator.
. This deficiency was corrected during the inspection by the posting of an appropriate sign.
License No. 21-04082-03 K
- 4. Condition No. 13 of this license requires that your teletherapy facility be provided with a system permitting continuous obscr-
. vation of the patient from outside the treatment room, during ,
patient irradiation.
Contrary to this requirement, the viewing vindow installed in
- the teletherapy facility at the Detroit Osteopathic Hospital does not permit continuous observation of the patient from cut- !
side the treatment' room in all modes of patient irradiation. l l
S. Condition No. 14 (A) of the license requires that teletherapy sealed sources be leak tested at intervals not to exceed six months.
S Contrary to this requirement, the cobalt 60 teletherapy sealed source was not 1 tk tested during the period from July 23, 1970 to March 16, 1971, a period in excess of six months.
- 6. Condition No.17(C) of this license requires 'that records of the ,
results of tests made of the electrical interlocks on the entrance doors to the teletherapy treatment room be maintained for inspection by the Consnission. ,
Contrary to this requirement, no records were maintained of the results of interlock tests which were stated by the licenses to have been performed.
- 7. 10 CFR 20.203(e)(1), " Caution signs, labels, signals, and controls,"
requ'.res that each area or room in which licensed material is used or stored and which contains any radioactive material in an amount exceeding 10 times the quantity of such material specified in Appendix C of this part shall be conspicuously posted with a sign or signs bearing the radiation caution symbol and the words:
Caution - Radioactive Materials."
i Contrary to the abwe, the teletherapy treatment room which contains a nominal 4000-curie cobalt 60 sou ce was not posted as required.
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