ML20127C258
| ML20127C258 | |
| Person / Time | |
|---|---|
| Issue date: | 09/26/1990 |
| From: | David Williams NRC OFFICE OF THE INSPECTOR GENERAL (OIG) |
| To: | Carr NRC COMMISSION (OCM) |
| Shared Package | |
| ML20127C175 | List: |
| References | |
| FOIA-92-277 NUDOCS 9301140096 | |
| Download: ML20127C258 (19) | |
Text
- .. r.
.-#p .%<h UNITED STATES NUCLEAR REGULATORY-COMMISSION
= *!' ca a WASHINGTON, D C. 205el
}
ji g September 26, 1990
%mcv/ *...*
OFFICE OF THE INSPECTOR GENERAL.
MEMORANDUM FOR: Chairman Carr .
hovk C bdfwm4 FROM: David C. Williams Inspector General
SUBJECT:
STAFF HANDLING OF THE UNIVERSITY OF CINCINNATI HOSPITAL INCIDENT Enclosed is-an Office of the Inspector General (OIG) Report of va, Investigation concerning an allegation of NRC staff misconduct- f related to a radiopharmaceutical incident at the University 6f Cincinnati in August and September 1984. la OIG' initiated }
Office ofbased on information the General Counsel.p @rovided by jallege es acted improperly by-accepting the hospital's representations concerning the_ incident and by concluding that the. incident-did not meet the requirements of the NRC misadministration rule.
The OIG investigation did not substantiate the allegation that the staff acted in bad faith or with malfeasance. However, the investigation determined that the staf f made an error in
~
accepting the hospital's representations--without having-sufficient information to make a determination as to whether the tisadministration reporting requirement had been violated.-
Th',s report is furnished for whatever action you deem hppropriate. please contact this office if further assistance is required.
Enclosuret Report of Investigation cc: W. Parler, OGC J. Taylor, EDO FREEDOM OF INFORMATION/ PRIVACY ACT EXEMPTION (b) (f) (6 information in this re:Ord was da!eted A ,e p . .O '
F01A-n M ~/ ~7 _
Fod @- ZD 9301140096.920827 -- (
hot -277 PDR
, 4
OFFICE OF THE INSPECTOR GENERAL REPORT OF INVESTIGATION STAFF RANDLING OF UNIVERSITY OF CINCINNATI HOSPITAL INCIDENT CASE NO. : 87-24 D
, , , . . ~ 3m
. nf <.4,.f g _% &v ..,. .m"-[./ % ,.
i f?W.f*
gsyg . .;. +n, b.4;Q?.
, f...~ c .g.. < %_,. . :-n.:)4. g: .. .. Wa;~. ', t f Yf I. . .
'f- .+' ,. .+ .
n g? ....:Wc .3 y k g ' 7' . ;[.
~Jh!'; .x$h
' 'G
~: :. . ,
R l4l&l% ;' '[2'
?.
& f, ;xe
. II.? . .
(f Igg .hk;,,.. ~
.. Y[.; .
- 1 .. $l$
-l
). ' . , - . :
7 : .
ff ^ y\. .- ..
);
n ,
. e'T v.
.J ' .-
y i
.s_; g . .
'...;s,...
.,? .
c,
"'I n ._ .r
.~ 5;.
ql$.. y. p .yt . ;?,; - .. c .t; Q
- r . ., .
- ;
Q, ? . ; . _ _; n ; ' E..
! i ' . .g '. .)
,s -w r.
%. ' .. y','Q . :.g.;..:i . .' g '$ys+..
< c.t
/.
- s. .
.3f ... .,;.... aj. f. u h ::
... g.$ k ny[ikf tbgf;bi hf a s Al{,., g,;;{Sy, y[.
Y, J p.
THIS REPORT IS THE PROPERTY OF THE OFFICE OF THE INSPECTOR GENERAL. IT MAY NOT BE PLACED IN THE PUBLIC DOCUMENT ROOM WITHOUT WRITTEN PERMISSION.
FREEDOM OF-INFORMATION/ PRIVACY ACT EXEMPTION (b) M) (6) (7)
P
INDEX Pace 3
SUBJ ECTS ...............................................
4 STATUTES ...............................................
5 SYNOPSIS ...............................................
7 BASIS ..................................................
DETAI LS 10 ALLEGATION 1 ......................................
15 ALLEGATION 2 ......................................
16 ALLEGATION 3 ......................................
FINDINGS 14 ALLEGATION 1.......................................
16 ALLEGATION 2.......................................
17 ALLEGATION 3.......................................
18 LIST OF EXHIBITS .......................................
3 SUBJECTS 1
a; h
1Jy -
gn nw 2
-7 . )g,4hb 7 'Yh$h1 ryg 9
-,. ,; . $Qig 34; ;
? 'a~#u. #
- {;
..'g
's e. ,, [
v
') %()
6 e m~
3?1 )~:jf: W + WT .
y at M .k'
- %.
- e:: s .e ; v a s a
~
- ~ro'(I.*
. ,. Aymyrsa m _.
r
y 4
STATUTES 10 CFR Part '0.7 3 5-49a ( f) - Conduct of Employees j .-
\
l
1 5
i SYNOPSIS f letter This nvesti tion was inigiated based- on a July 6, .1987, from ,J Office of the General Counsel, concern ng a ra armaceutical incident at the University of '
Cincinnati.Hosptial.- on August 28, 1984, a terminally containing-ill:
patient was-implanted with sealed sources (seeds)After the seeds Vere remov radioactive iodine 125.the hospital determined that one of the eight September 1, 1984, seeds had leaked into the patient:and had irradiated'the thyroid.
$$3lllallegedthatthestaffactedimproperlybyacceptingthe '
Hospital's representations concerning.the incident and byt meet the requirements concluding that the incident id alleged that 'af ter the NRC misadministration rule. _ on from.the office of-Commission requested a determconcerning whether NRC rules had been Investigations (OI) violated, staff compromised the investigation Hovember by,28, contacting 1986, and-the licensee, ,so j M1986, also alleged that onthe staff reported the same inaccurate December Ib, '
f information to the Commission and Commissioners' Assistants,'
which the licensee had pre viously reported to the NRC in 1984.
The investigation revealed that the staff. failed to question the hospital regarding the The specific staff events assumed and actionshospital that_the undertaken made:a-during the incident.
medical decision based on the Yet, knowledge the' hospital that a subsequently-sealed source was leaking inside the patient. --
maintained that they did not definitely know, but' rather only.
suspected *he seeds -were leaking insida -the patient. b The staff deferred to the hospital's' argument.that the incident they- hadi made- aL medical .
was not a_ misadministration becauseHowever, the staf f did not decision to continue treatment. _
question when the hospital _made the decision and_why the.The staff main determination was made.
decision was made; on the first . cur last -day of -treatment was:
irrelevant, as long as it occurred'during the_ treatment _ process.
The staff subsequently-inferred that-the decision was made early-in the treatment. However, review of the incident.revealedithat the decision was made just prior to the. scheduled explant of the coaled sources.
The staff did_not obtain a. legal opinion By concerning notidoing so, whether the-staff the incident.was a misadministration. ,
reached-an erroneous conclusion that the misadministration rule did notiapply.
The investigation disclosed that shortlyLafter the office of- -
Investigations initiated-its investigation,-OI requested The staff the staff to ascertain _whether-the patientOIG was alive.
concluded that-OI=
accordingly contacted the hospital.
, ,, w . . - ,..4- -
u - , . _ , . _y. , - -
h .-
9 6
authorized the contact and in OI's opinion this action did not compromise the investigation.
The investigation also disclosed that the November 1986 memorandum to Chairman ZECH and the December 1986 briefing paper to the Comnissioners' Assistants did not identify the correct data and circumstances surrounding the hospital's medical decision. Because the staff failed to adequately review the incident, it incorporated inaccurate informat on i
which the hospital had provided in 1984.
f 7
DA8IS Thi M's "43 ationincident investic a contaminatnon was initiated based on a letter fromE office of the at the- University of Cincinnati Hospital (UCH), an NRC licensee, which occurred in August and Septemberi On August 27, 1984, a patient was' implanted 1984scaled with (Exhibit 1).
sources containing radioactive iodine 125 (I-125) to-After the sources were removed on treat a malignant brain tumor.the university determined that one of the September 1, 1984, was inadvertently punctured and had irradiated sources (seeds) the patient's thyroid. The hospital subsequently advised NRC that they made a medical decision to continue the patient's treatment af ter it had discovered a contamination problem in the brachytherapy source storage room.
alleged that it was malfeasance on the part of the staff to e a sled by the licensee into believing that the university knew of the inadvertent I-125 exposure before it actuallythe did_and, treatment that it made a deliberate medical decision dLrin maintained the process to allow the exposure to continue. lll university did not know that the seed was i;akang until af ter the treatment process. Therefore, the hospital could not have made a medicaldecisionto.allowaleakingseedtoremainin.thellllll As evidence of the staff's acting in bad faith, patient. not-a maintained the staff concluded that gal theopinion incident w from 6 misadministration in spite of it was. alleged possible co usnon
[; Q & % W 2 thatbetween the staff and the 1 consee because the staff : accepted t hospital's representations notwithstanding-that during a '
telephone conference call, the licensee told NRC that they would.
have left the seeds in the patient "even if they had known the seeds were leaking during the treatment." <
! alleged that after the commission authorized 01=to conduct ss the an nvestigation, the staff contacted the nospital t also incident and thereby compromised the investigation. he alleged that the staff provided inaccurate information to Commission in an EDO memorandum, dated November 28, 1986, and in a commissioners' Assistants briefing paper, dated December 15, 1986. Specifically, these documents provided an account of the incident that repeated the same inaccurate information which the licensee had reported in 1984.
DACKGROUND University of Cincinnati Incident On August 27, 1984, physicians at the University of Cincinnati Medical Center temporarily implanted eight sealed iodine -125 (I-125) sources into the brain of a terminally ill patient.
The sources were scheduled to be removed on September 1, 1984. On-
- , _. _ . . _ _ _ _. .- -_ _ ,_ a. _ . -.
8 August 28, 1984, wipe testing of containers in the brachytherapy The room was source storage room revealed I-125 contamination. On August 29, 1984, the subsequently sealed and decontaminated.
patient's lead hat andTests bandage of was the wipe tested technicians and did notfor responsible reveal any I-125 leakage.
loading the implanted I-125 seeds were scheduled. On August 30, 1984, thyroid counting showed that one of the technicians had measurable uptaxes of iodine. Thyroid counts were ordered for all personnel at risk. Approximately 60 persons Urine were tested samples were between August 30 and September 10, 1984.
taken from the patient on August 31, 1984. Results of1984. the patient's urine sample were obtained on September 4, After the concluaion of the prescribed therapy, the seeds were removed on September 1, 1984. Survey of the patient's thyroid revealed that the thyroid had been irradiated. It was subsequently determined that one of tho seeds was punctured prior to being implanted in the patient. On September 4, 1984, the patient returned to the university for further tests (Exhibit 2).
NRC Region III Inspection NRC Region III was initially notified of the contamination in the brachytherapy room, the thyroid contamination in hospital 1984 ,
personnel and the (ExhibitIII2 requesteI at 3). p@atient's thyro,id on September MWW4MThMIMin*di 7mmut NRC 4, Region @the hospital to provide a written summary of the incident (Exhibit 3 at 5; 4 at 19).
On October 10-12 and October 30, 1984, [ D M conducted a special announced inspection to review the facts surrounding the
. damaged _I-125 source that was removed from the patient.
Egwa*% held an exit conf erence on October 12, 1984. During rhis me6 ting, @j${T S and the hospital personnel discussed whether the incident was a misadministration. The hospital told fWM that a medical decision breatmentasplanned. had been the After discussing made to continue the misadministration issue with Region III management, NRC and hospital personnel conducted a telephone conference call to resolve the issue on made a October 30, 1984. The hospital again advised that t medical decision to continue the treatment process. wa E5331ESEEiTIId22E8$$1LdddM3fMM Region III, requested the hospital to document the medical
-4 _ _ .}
decision (Exhibit 2; 3 at 15, 19; 5 at 11, 12; 6 at 31).
On Novemb.er 2 1984,k f h k hhkk NMW V3M$1MhJE documeNTe!1 the hospital's medical decision.
@he T 16tter stated 'that "When it was noted that there was iodine le _akage a conference was held betweenGEN7h $ff W g g y m jad
[fCgigj]E. It was felt that because of the sign 1ficant medical problem, recurrent malignant brain tumor, the patient's implant should be continued to achieve full dose" (Exhibit 7).
4 9
On December 17, 1984, Region III released an inspection report which summarized the inspection and findings and included aThe summary of the events leading. to the leaking I-125 seed.
inspection summary stated "on August 29th, a wipe test of the patients lead and bandage revealed no contamination"; the attached narrative stated "on August 29, 1984, a wipe test was performed on the lead shield covering the patient's head and When the wios tests revealed no bandage covering the implant.it was decided to continue with the treatment" contamination, (Exhibit 2).
Attachments to the NRC inspection report included the hospital's incident. The chronology and documentation concerning the hospital chronology reflected: August 29, 1984, " Wipe testing of patient's hat and bandage revealed no leakage, and Also,it reflected was therefore decided not to remove the sources."
was that on August 30th the hospital conducted thyroid counting of the technicians and that "there was to 557 uCi found in the patient (see Appendix B)." According Appendix B, thyroid counting of the patient occurred on September 5 (Exhibit a).
The NRC inspection report identified two violations: (1) the unauthorized opening of a sealed source (the I-125 seed); and (2) the f ailure to perform an adequate survey to det et lowletter level the contamination. The report stated that based on nce a NRC determined that no misadministration occurrs medical decision and evaluation was achieved and the patient's implant was continued to achieve treatment" (Exhibit 2),
10 CFR Part 35 defines a misadministration in part as, "a radiopharmaceutical or radiation by route of administration other than that intended by the prescribing physician." The reporting requirements of 10 CFR 35.42, now incorporated in 35.33, requires notification to the NRC within a prescribed period following the discovery of a misadministration.
Investigation by the Office of Investigations, Region III The Of fice of Investigations was requested to review whether the licensee misrepresented f acts surrounding the contamination incident to the NRC. On October 27, 1988, OI concluded that the evidence did not support a finding that the hospital willfully However, OI failed to report a misadministration to the NRC.
determined that the hospital's chronology contained inaccurate in f o rmation. Specifically, it wasust determined that the medical 29, 1984. OI concluded that on decision did not occur on sand, or about August 31, 1984, that the patient might be the
[gjjglhdiscussed the "possisource of the contamination prcblem and therefore a de made to continue the planned treatment until September 1, 1984 (Exhibit 9 at 2, 19).
10 Differing Professional opinion Panel .
On May 21, 1990, a Diff Professional Opinion Panel (DPOP) disagreed with OI's conclusion. On was established because ded that the contamination incident July 12, 1990, .the DPOP conc They also concluded that there was was a misadministration.
insuf ficient evidence the licensee "significantly misstated facts regarding the incident and misled the NRC" (Exl.ibit 10 at 3).
The DPOP stated that the hospital chronology included inaccurate statements for August 29th and 30th but that the inaccuracies were inadvertent. They further stated they could not have been used to mislead NRC because[gys3 did not rely on the chronology to reach the regulatory conclusion Similarly, the that DPOP no stated that misadministration had occurred.
the information concerning the wipe test could not have been used to mislead NRC to believe that the hospital know the seeds were leaking on August 29, or that a medical decision was made on this The date knowing that the patient's thyroid would be irradiated. . ,5 r
DPOP commented that it was not convinced that the hospital "ever claimed having actual knowledge of a leaking source in the .
patient" (Exhibit 10 at 38, 36, 35, 43).
DETAILS - ALLEGATION f 1 i Medical Decision Issue Review of the NRC inspection report did not indicate when the hospital determined thatThe the seeds attachedwere the source hospital of the did not chronology contamination problem.
identify when the hospital knew the seeds were leaking in the patient. Both the NRC inspection report and the hospital's chronology reflected that af ter the seeds were removed on September 1, 1984, testing of the patient's thyroid revealed that the thyroid was contaminated (Exhibit 2).
The NRC inspection report also did not indicate whether there had '
been continuean inquiry as to when a mediqal dec.}ision was made toAlthough$$$$]E the treatment.
when the decision was made, the NRC inspection summary stated' that the decision was made af ter the vi e test was conducted on August 29, 1984. However, both }and(2C3EEE$ advised that they never asked the hospital v en the medical decision was made (Exhibit 2; 4 at 34; 5 at 15, 36).
1 stated that llll concern during the inspection was to eterm ne the extent of the contamination event and whether procedures were violated. The hospital chronology was accepted without question although it was not intended to be a final document. l[ understanding of the chronology was that the hospital aely suspected a leaking seed on August 29th
11 and therefore a wipe test was performed, k$[f(( assumed that the medical decision was made based on the reiUIfEs of the wipe test (Exhibit 4 at 34, 25, 26, 27, 33),
myV tated that a misadministration was the "last thing on Z 4'mD hen I did the inspection,"M5lMadvised Ey and t did not become an issue until after the inspection. [ E never never thought of focused on the medical decision. Moreover, asking when the decision was made and probab y never asked who made the decision. The misadminis ation isque was initially discussed at the exit conference. % E Q stated that during the meeting, the hospital put @ident on astheadefensive and made it misadministration.
clear they did not view the inc The hospital advised [!jid that regardless of whether the seed was leaking, the patient was going to receive the full therapy (Exhibit 4 at 34, 3 at 12, 16; 4 at 28, 29, 30).
m.-
Gf;f , said that NRC conducted the October 30, During 1984, conference the call, call to resolve the misadministration issue.
the hospital advised that af ter they determined there was a leakage problem, they decided .to co tinue the treatment because of the patient's condition. [ 2 3 7 stated that the wipe test was a useless test and was not the basis for making the decision to leav the seeds in or to take them out of the patient.
{t]rea tme nt,P said Q near "probably assumed the decision the end, probably was made30th, the 29th, sometime28th" during the (Exhibit 5 at 11; 6 at 30, 31; 5 at 30, 27 15),
[ d stated that [ M . November 2, 1984, letter convinced @
h'that the hospital made a deliberate medical decision to continue treatment. L2Ec.T3 advised that the doctors made the decision regognizing that th'e thyroid would be irradiated. Further, in
[ f3 opinion, the hospital had enough " preponderance of evidence" to leaking in the patient.
61$46s gpgeg de that the seeds wereknew interpretation of
" iodine the seeds were leakin leakage" referred to the leaking in the patient's head (Exhibit 5 at 12, 17, 45; 6 at 24, 26, 33; 5 at 34, 36).
Hisadministration Issue prepa a,I 3 N $& y.au n= red w mthe=~inspection x mawreportp w~which was reviewed by s
n,Jy mm .&m msug m sm n -_wmaag m,n m m Region III and approved jy (Exhibit 11 at 5, 6). efore finalizingthereport,[- ""
consulted NRC Region III and the Of fice of Nuclear Mater al Safety and Safeguards (NMSS) headquarters staff concer ng whether the incident was a misadministration. ((@ ld_iscussed the issue withf @ g
- E h NMSS.
@$]M and the enforcement was not a misadministration. However, boart{adv sed that t
, advised that it
l 12 l
was. (Exhibit S at 13, 14).
$ $ Mj
@Ydressthemisadministrationissue.\ advised After that reviewing an the original inspection internal a
NMss document on misadministrations, discussing the incident with the hospital and receiving assistance from headquarters, the staf f determined that a physici n could change his diagnosis during the treatment process. 92D5ERWJstated that af ter discussing the issue with the staff concluded in the inspection report that the inc t was not a misadministration (Exhibit 11 at 4, 5, 7, 8, 10).
stated that although 3 ultimately made the decision that
[k as a misadministration, M mistake was in not
'El going e incident back to y{Ey af ter receiving conflicting in ormation from it 5 at 14; 6 at 33 (fild - istated M the init NMSS lally described staff (E the incident to GM), but id not tell
@ffMthatthehospitalmadeamedicaldecisiontocontinue treatment (Exhibit 5 at 13 14). $ @ subsequently discussed the incident with E[% M an,d reviewed ~th4 NMSS policy document which described various examples of misadministrations (Exhibit 5 at 13, 6 at 32).
h1TEensee,stated,gwas that based on con % discussions Wnced there was awith NMSS medical andtothe decision continue the patient's treatment. further stated that the doctorschangedtheprescriptionfo@rthebenefitofthepatient and therefore, the incident did not meet the misadministration rule. According to (( F l } the doctors could have changed the prescription at any time duringatthe thetherapy andor beginning noend matter when of the the decision occurred (i.e.,
treatment process), it would not have affected NRC's regulatory decision (Exhibit 5 at 13, 14, 43; 6 at 13).
According to h [ $ 5 M El advised that the attending physicians made a conscious decision to continue the treatment had knowledge that there was some leaking in the even thoug@h theE R discussed the incident with W patient.
W2EDEMi$]$$B M EW WCi?!ML&W ~. N?.
(NMSS, who advised that it was not a misadmin stration. _
stated $ essentially went along with M b andfik who was the expert on the misadministration rule (Exhibit 12'at 12, 7).
r1 '
i l had been developed 7ater&)statedthatthemisadministratonrueclear history of mistakes were documented in c procedures that were best characterized as human error. @Q advised that the rule was not intended to apply to the type of
@.incideat MM stated which however, had that occurred at the "university Shad trouble buying of f"(Exhibit on the 13 at 6) .
theory that the incident was not a misadministration because of a physician's decision to leave the seeds in during the treatment
13 process. According to a doctor's decision after the .'
fact, should not be "use as a basis for determining whether this was a misadministration-reportable event" (Exhibit 13 at 13).
conversa ion vi as an PofficialOGCistated infon. % since However, did notasviewfhla wou ~have 6-land
' expected to seek additional OGC adv ce after obtaining differing y evs rom the staff (Exhibit 14).
ll!llladvisedthatalthoughtherewasstrongdisagreementamong llthe staf f concerning he hospital incident, the staff knew the rules. According to 23dh as long as the licensee gave NRC a reasonable explanation, the staff would " bend over" to find in-the licensee's favor. The staff would do so because they did not want to interfere with medical decisions and had " strenuously" disagreod with the rule when it was originally proposed.
Possible Collusion Concerning Staf f's Determination That Incident was Not A Hisadministration Region III did not document the October 30, 1984, conference call, however, the staff reported that the hospital advised "even if they had known the seeds were leaking during treatment, therapy would have continued" (Exhibit 15 at 8).
f f' . documented the hospital's medical decision and the statt'( conclusion that the incident was not a misadministration in a memorandum-dated December 11, 1984. -The memorandum reflected that "the physicians stated that even had they known if the seeds were leaking, at the time of treatment, therapy would have continued" (Exhibit 16).
As a result of .the OI investigation, doc umented
- October 12, 1984 exit conference with the licensee. 3 October 9, 1987, memorandum stated that the hospital advised they.
I did not know the patient was the source of contamination during treatment. However, they had not ruled out the possibility.
Further, even if they had that evidence during the treatment process, treatment would have continued (Exhibit 17) .
hhd andhhMB,were questioned concerning the apparent discrephncy between NRC's conclusion that the hospital made a 1 medical decision based on the' knowledge or suspicion that the seeds were leaking, and their memorandums reflecting that the hospital had dvised NRC that they did not know the seeds were leaking. In opinion, the statements were not contradictory. nterpretation was that the hospital probably meant if the wipe test had shown contamination or if they had.
known with "a hi h degree of certainty," treatment would have the hosp made
! continued. . } commented that alth letter.
this statement, it was made prior to
. i e
14 reiterated that the letter convinced Y .that the hospital made a medical decision, regardless of the leaking (Exhibit 5 at 33, 3 4, _
37; 6 at 25,- 32, 33).
In pinion,theposita did not provide contradictory According to after the wipe test, the 3 information.
hospital probably did not know with "100% certainty" where the iodine was coming from. But the hospital had consistently 7
maintained they made a conscious decision prior to explant that whether the seeds were leaking or not,-they were remaining in the patient. [ M acknowledged that the hospital's representatIonswe mad fter they know that one of the seeds s' . stated one" that thought the incident had leaked. Yet,, ibit 3 at 16, 19; 4 at was a misadministra on from "da never expressed this 8, 10).
Accor:llEling %W hadto@le amp opportunit to do so (Exhibi t-view, althou and who 23). also stated that it was initi y told . that based on HMSS criter a, do tors cou decide to chang prescription if they found an error during the treatment process, and in light of a medical decision that was in the best interest of the patient, it would not be a 5 at 8, 9, 6 at-5).
mpsadministration(Exhibit
. Hos ' a staff members, 1984,
~: participated in the Oc er ,
conference call, did not recall the conversation, but tggl$
handwritten notes re ected in part: " treatment of tumor was continued for the best interest of the patient; NRC requested that the hospital put this in writing. NRC will not consider this a misadministrat s ce the medical decision was to continue treate a stated that i vaguely recalled the conversation. -
. notes re lected in par : " provide in. writing
-no difference n treatment if leakage found earlier (8-29-84)--
medical decision made" (Exhibit 18 at 36, 18a; 19 at 6; 19a).
FINDING - ALLEGATION fl The investigation failed to substantiate the allegation However, the that the staff acted in bad faith or with malfeasance.
investigation determined that staff did not adequately review the incident and made an error in accepting the hospital's representations.
The staff incorporated the hospital's chronology into NRC documents without, in:some cases,.an appropriate aff inquiry as to apparentiv the facts which supported the chronolog The did not focus on the medical decision. advisedthatl E was primarily concerned with the contam nat .on ssue and not wath-whether or not the incident was a misadministration. Because the l-i staf f did not determine when the decision occurred, they later inferred that it was made after the wipe test.
j 15 The staf f accepted the hospital's representations concerning the medical decision without having suf ficient information to make an appropriate determination as to whether the misadministration reporting requirement had been violated. The staff assumed that the physicians could make a decision to change a prescription during the treatment. They also assumed that the doctors could make the decision on the first or last day of treatment, as long as it occurred during the treatment process. Accordingly, the staf f maintained that the timing of the medical decision was irrelevant. The staf f f ailed to question the plausibility of a medical decision that occurred the night before the scheduled removal of the seeds. The staff did not seek an official OGC As opinion after receiving conflicting opinions from NRC staff.
a result, the staff erroneously concluded that the incident was -
not a misadministration.
The investigation f ailed to disclose any evidence of collusion between the staf f and the hospital concerning the staf f's predecisional representations that the HRC would,d4gggine the incident was not a misadministration. Althoughlyjai1J ,sq n
handwritten notes of October 30, 1984, may suggesk possible -
collusion. they are not conclusive proof. The staff was correct in requesting the hospital to document the medical decision.
However, the staf f may have inappropriately advised the hospital of what NRC's conclusion would be as a result of t.he ospital's documented medical decision. The DPop noted that i was "not naive about the purpose of the letter when he prepared it."
([$35dk letter omitted specific information concerning when the hospital initially determined that the patient was the source of the contamination and when the ho ital made the medical decision. As previously stated, ffE5 interpretation of the letter was that gg " iodine leakage" referred to the leaking in the patient, hirts explanation that the " iodine leakage" referred to the gen 4ral contamination in the environment, and not the patient, occurred well af ter the allegations were made.
While the staf f had no apparent motive in reaching a determination that the incident was not a misadministration, there could have been legal ramifications for the hospital.
DETAILS - ALLEGATION f 2 b
hffinvestigationconcernIngth hos.
Region III conducted the OI tal's alleged misrepresentations to NRC. ; . 4 stated that after receiving the request for the investig tioni EW asked @RM vhether the m subseg ently advised M that patient was still the patient had died. alive. T@
AcF6r ding to@h3DEdMe jcontact did not compromise the investigation (Exhibit 20 at 5, 6).
determine whether or not the patient (EYMG}contactg@m..
was 1.isiing. Guag asked . Sto$about the iodine leakage and if and (({}[had a discV'ssion regarding continuation of treatment I
(
16 did not view the contact as improper because k[f had 9 '
equested the information (Exhibit 5 at 41, 42).
FINDING - ALLEGATION f 2 The investigation concluded that h N requestedf5 to R
obtain information concerning the pat:.ent. Therefbre, .
contact with the licensee was authorized by oI and in ol's opinion did not compromise the investigation.
DETAILS - ALLEGATION f 3 S M allegations, Chairman ZECH requested the Asaresultof(Eoseveralquestionsconcerningthecontamination EDO to respond incident. The November 28, 1986, EDO memorandum concluded that after further staff and OGC review, the incident "would be more appropriately classified as a misadministration" (Exhibit 21).
The memorandum recounted the medical decision and stated that the incident had been thoroughly discussed with the licensee. It referenced a discussion with the Q M 8 M 9 E?f E M M W )
The memorandum stated that tholospital on November 24, 1984.
suspected leaking .soeds on August 28 or 29, 1984; and the attached summary of the incident reflected that on August 29, 1984, a medical decision was made to continue treatment knowing that the patient's thyroid would be irradiated. The statement concerning the medical decision was not included in an earlier draf t of the attachment (Exhibit 21 at 2; 22).
The briefing paper for the commissioners' Assistants, dated December 15, 1986, documented the chronology of events leading to the ruptured I-125 seeds; the licensees' actions and corrective measures; and NRC enforcement actions (Exhibit 15). With respect the docu t reflected that: on August to 28 the medical dgelsion1984, $$ Iand; $pe or 29, " met to discuss the iodine leakage" ... and that "on August 29, 1984, wipe testing cf the patient's lead hat and bandage revealed no leakage, and it was decided not to remove the sources."
James SHIEZEK, Deputy Executive Director, Nuclear Regulations, Regional operations & Research was the final approving official before the EDO's signature. SNIEZEK stated that he did not specifically recall discussing the memorandum with staff or whether the summary of events was attached prior to his concurrence. SNIEZEK did not know that the information concerning the medical decision was inaccurate. SNIEZEK stated the staf f ultimately concluded that the incident should have been a misadministration. Therefore, the timing of the medical decision would not have altered or have made a difference with respect to the regulatory conclusion (Exhibit 23).
h@gls Mh MSS,-
f Mwas E bresponsible b dEE EN$I3 for coor d 3s @d$nating theE2d
17 preparation of the November 28, 1986, EDO memorandum and the December 15, 1986, briefing paper. E { @ was not involved in the initial determination of the contamination incident. NMSS headquarters, OGC, OE and Region III staf f were principally5, involved in areparing the EDO memorandum (Exhibit 24 at 4, 12),
and essentially made the presentation to the commissichers' FLU 7 '
Assistants (Exhibit 5 at 26).
Although the EDO memorandum referenced a November 24 1986 telephone call with the[ Z @ f M g M M 7 Q bf { Ef 7 M ,
recall havIng a conversadon with ti and stated (Exhibit that 25 $atdid no)g Tf2 3J stated that @ did not ca)J 31).
jy presumed stated that Region the only III made the call conversation (Exhibit k;7had was 24withat 8 ,bd) concerning whether the patient was still alive (Ex ibit 6 at 38).
mpm; stated that h did not discuss when the medical decision m;g; L #f 4 assumed that the decision Tas made occurred afterwith the the wipestaff.
t [Ed issue, C Q Qnorstated did itthat the EDO specifically comorandum did not focus on th iefing state when it occurred. W W acknowledgedHowever, that th paper did state when the ecision was made.
stated that the timing of the decision was immaterial o e staff's determination that the irpjdent should have been a misadministration. According to Q 1 % the staff's documentation of when the incident occurred did not make any dif f erence because a misadministrattion was not " tied" to a medical decision. Further, {;T E @ dvised that the important issue was when the doctors had positive indication that the thyroid had been irradiated and therefore the hospital should have known that a misadministration had occurred (Exhibit 24 at 23, 37, 34, 20, 23, 24, 30, 37).
advised that the staff tried to explain the circumstances hThe surrounding the incident and reasoning behind their decisions.
staff relied on existing documentation z.ad memory to prepare the information provided to the Commission. The staff did not because of the potential OI investigation.
contact the hosgig gd the information concerning the timing of was a result of the October 30, 1984, According conference callto the medical de with@$1;sion[Q A or Q~3 subsequent discussion with[h.
~
5 N Q with acknowledged however, that Q may have combined Q
[GI$er the hospital chronology"and assumed that the physicians' discussion and decision occurred on August 28th or 29th (Exhibit 6 at 40; 5 at 68, 72).
FINDING - ALLEGATION #3 The EDO memorandum and the briefing paper for the Commissioners' Assistants did not identify the correct date or circumstances surrounding the medical decision. However, the investigation
9 4 18 failed to substantiate that the staff knew the information was inaccurate. The staf f never determined when the hospital initially suspected that the patient was the source of the contamination problem or the timing of the medical decision.
Although the EDO memorandum implied that the staff verified the information during a telephone conversation with the hospital, the investigation did _not determine who made the call and w once, at was discussed. fA 9 W stated that e e'rmine definitely called however,theinv{dWfMTfondidnot whether there were additional calls.
Ohi ar
%qW y,b1ts **N W e.r-m-k'- *yew 's >rc 7"w&
tn 1 -ta$"*c:"
%Uiy O 6 Pjm wW^a Ch:?;;;
WO%mOmQF W f JVV N kuk a
MM $[I6N a@fh.@y Ng hlkd _g,$ 5ha[Dw n {?@h 3. Y) % L...L %p::b ,
w q ,x T QN.C 'w Y 8 6 ;'w -
^ 9 jt}h.-tfi+ N(
f p:w}3 ; h, Q
[w^:h rQR;;MT-: bt ::#%t W@? g n ff :t g m , yA g p
'u: g 4;';,
7-e G .3 p3y 4r 3qn.mm y;{&>:alP^ ;;; c y(
p8 4 .: ~p s y, . q 4 MaV C x 6.g 4p:e Ti1%g;ys c .:J
- W &gbg+a 'Q t % nm(yfp
- '.
WO WW o -UN er 77f n @un?k';.i f
r ura NZTS hj $y;f.h$y$ Sk ' $Q"[y;
-: t
! %y 4 . NP .s;[ .;
. fW&:l W g; )%f. ,3 n A}! W h di! hQ gm y an. LM) ' )l..
$q$g% R N M Q py&p&N,'vswpMx m y sw'tfgyj
% Wp$ GWnp@;%hf g tig 2 a r u% ?y } %@ Q l.- y fQ %p % w .
[ l 9
}, eh l. y
,.I y %;f:% yf
<. y mq
~ ysd3 QQ R
%; } Q e{
y y
m: ,
1 tg w ye s y a r G m
~
h:> a e p k i
f[
e w g f w lggdy an ,
y s 2eg w%ad;#Vp &nu xm vw m m u @yky@:w. q (6}v
%w %gms;:oNM:q
? d fn f k aq eyk,n s
3u:q%~ 4%y, py m '
s.
[Qxn c: g(>mm%g,gemv.y' w
j yt I@" i s _%J l." g. $h ' ' h . [d nm'a y-og ym m #W. s; h '_x nac n m%gl }lt -
1 :s
> y u;;Lb3: h j 5
_ Qy[. .) 'Y
' {Q l l $ggj&yWlfMy{*&_ #:f
&Q k$[ .
, R:X$
. nw f &lSs M , QWun ww.
L. C:Q. % 4 V ,.
fhff jQigz
- a HQ$&w.??? 4 lTi ' $.
att a.
i kgjp$$ %m ;
e m w %e w%qsdp gNhMM g p g#UM 4 @N N Y$ 3Qp,"MWfMfdlEinh mw " k 4A %@Q e i l
e QQ: yyqw :N.h n%sa&m$ER7TM%%n%R$A W sp :;J@m ;3Q:k
?Q k%w[g.,fi \ p*
j t
& _llly f $ $?$ $yy y @ D ; g $ b W b l0 W W ;W $ 4 ' W M S O k; th -
l l
l I
I l
l l
l
,