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) | |
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.-#p NUCLEAR REGULATORY-COMMISSION UNITED STATES
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WASHINGTON, D C. 205el ji g
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September 26, 1990
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OFFICE OF THE INSPECTOR GENERAL.
MEMORANDUM FOR:
Chairman Carr hovk C bdfwm4 FROM:
David C. Williams Inspector General STAFF HANDLING OF THE UNIVERSITY OF
SUBJECT:
CINCINNATI HOSPITAL INCIDENT Enclosed is-an Office of the Inspector General (OIG) Report of Investigation concerning an allegation of NRC staff misconduct-va, f
related to a radiopharmaceutical incident at the University 6f Cincinnati in August and September 1984.
la OIG' initiated based on information p @rovided by
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Office of the General Counsel.
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
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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
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OFFICE OF THE INSPECTOR GENERAL REPORT OF INVESTIGATION STAFF RANDLING OF UNIVERSITY OF CINCINNATI HOSPITAL INCIDENT CASE NO. :
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kny tbg 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)
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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
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STATUTES 10 CFR Part '0.7 3 5-49a ( f) - Conduct of Employees j.-
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1 5
i SYNOPSIS f
letter This nvesti tion was inigiated based-on a July 6,.1987,
,J Office of the General Counsel, armaceutical incident at the University of from concern ng a ra on August 28, 1984, a terminally ill:
Cincinnati.Hosptial.-
containing-patient was-implanted with sealed sources (seeds)After the seeds Vere remov radioactive iodine 125.the hospital determined that one of the eight
- 1984, seeds had leaked into the patient:and had irradiated'the thyroid.
September 1,
$$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 by, contacting the Hovember 28, 1986, and-j M also alleged that onthe staff reported the same inaccurate
- licensee,
,so f
December Ib, 1986, information to the Commission and Commissioners' Assistants,'
viously reported to the NRC in 1984.
which the licensee had pre The investigation revealed that the staff. failed to question the hospital regarding the specific events and actions undertaken The staff assumed that_the hospital made:a-during the incident.
medical decision based on the knowledge that a sealed source was leaking inside the patient.
Yet, the' hospital subsequently-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:
as long as it occurred'during the_ treatment _ process.
The staff subsequently-inferred that-the decision was made early-irrelevant, However, review of the incident.revealedithat in the treatment.
the decision was made just prior to the. scheduled explant of the coaled sources.
The staff did_not obtain a. legal opinion concerning whether the incident.was a misadministration.
By notidoing so, the-staff 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 The staff staff to ascertain _whether-the patient was alive.
OIG concluded that-OI=
accordingly contacted the hospital.
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_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 Because the staff failed to adequately review the decision.
incident, it incorporated inaccurate informat on which the i
hospital had provided in 1984.
f 7
DA8IS M's investication was initiated based on a letter fromE office of the Thi "43 a contaminatnon incident at the-University of Cincinnati Hospital an NRC licensee, which occurred in August and Septemberi (UCH),
1984 (Exhibit 1).
On August 27, 1984, a patient was' implanted with scaled 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 hospital subsequently advised NRC the patient's thyroid.
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 actually did_and, it made a deliberate medical decision dLrin the treatment that process to allow the exposure to continue.
lll maintained the 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 the incident w misadministration in spite of gal opinion from 6
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 nvestigation, the staff contacted the nospital t also an 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, Specifically, these documents provided an account of the 1986.
inaccurate information which the incident that repeated the same 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-into the brain of a terminally ill patient.
The 125) sources 1984.
On-sources were scheduled to be removed on September 1,
- a.
8 1984, wipe testing of containers in the brachytherapy August 28, The room was source storage room revealed I-125 contamination.
subsequently sealed and decontaminated.
On August 29, 1984, the patient's lead hat and bandage was wipe tested and did not reveal Tests of the technicians responsible for any I-125 leakage.
loading the implanted I-125 seeds were scheduled.
On August 30, thyroid counting showed that one of the technicians had
- 1984, measurable uptaxes of iodine.
Thyroid counts were ordered for all personnel at risk.
Approximately 60 persons were tested between August 30 and September 10, 1984.
Urine samples were taken from the patient on August 31, 1984.
Results of the 1984.
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 the thyroid contamination in hospital brachytherapy room, 1984 personnel and the p@atient's thyro,id on September 4, MWW4MThMIMin*di 7mmut NRC Region III requesteI @the hospital to provide a written summary of (Exhibit 2 at 3).
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.
1984.
During Egwa*% held an exit conf erence on October 12, rhis me6 ting, @j${T S and the hospital personnel discussed The hospital told whether the incident was a misadministration.
fWM that a medical decision had been made to continue the breatmentasplanned.
After discussing the misadministration issue with Region III management, NRC and hospital personnel conducted a telephone conference call to resolve the issue on October 30, 1984.
The hospital again advised that t made a medical decision to continue the treatment process.
wa E5331ESEEiTIId22E8$$1LdddM3fMM - 4
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Region III, requested the hospital to document the medical decision (Exhibit 2; 3 at 15, 19; 5 at 11, 12; 6 at 31).
1984,k f h k hhkk NMW On Novemb.er 2 V3M$1MhJE documeNTe!1 the hospital's medical decision.
@he 16tter stated 'that "When it was noted that there was iodine Tle _akage a conference was held betweenGEN7h $ff W g g y m jad It was felt that because of the sign 1ficant medical
[fCgigj]E.
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 August 29, 1984, " Wipe testing of hospital chronology reflected:
patient's hat and bandage revealed no leakage, and it was therefore decided not to remove the sources."
Also, reflected was that on August 30th the hospital conducted thyroid counting uCi found in the of the technicians and that "there was 557 patient (see Appendix B)."
According to 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) f ailure to perform an adequate survey to det et low level the letter 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),
"a 10 CFR Part 35 defines a misadministration in part as, radiopharmaceutical or radiation by route of administration other The reporting than that intended by the prescribing physician."
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 failed to report a misadministration to the NRC.
However, OI determined that the hospital's chronology contained inaccurate in f o rmation.
Specifically, it was determined that the medical decision did not occur on ust 29, 1984.
OI concluded that on
- sand, or about August 31, 1984, that the patient might be the
[gjjglhdiscussed the "possisource of the contamination prcblem and therefore a de 1984 made to continue the planned treatment until September 1, (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 (Exl.ibit 10 at 3).
regarding the incident and misled the NRC" The DPOP stated that the hospital chronology included inaccurate statements for August 29th and 30th but that the inaccuracies They further stated they could not have been were inadvertent.
used to mislead NRC because[gys3 did not rely on the chronology to reach the regulatory conclusion that no Similarly, the DPOP 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 date knowing that the patient's thyroid would be irradiated.
The
.,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 that the seeds were the source of the contamination problem.
The attached hospital chronology did not 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 an inquiry as to when a mediqal dec.}ision was made toAlthough$$$$]E continue the treatment.
when the decision was made, the NRC inspection summary stated' the decision was made af ter the vi e test was conducted on that 1984.
However, both
}and(2C3EEE$ advised that August 29, 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 and t did not become an Ey hen I did the inspection,"M5lMadvised E never issue until after the inspection. [
focused on the medical decision.
- Moreover, never thought of 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 on the defensive and made it the meeting, the hospital put @ident as a 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).
Gf;f, said that NRC conducted the October 30, 1984, conference m.-
call to resolve the misadministration issue.
During the call, 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 assumed the decision was made sometime during the "probably near the end, probably the 29th, 30th, 28th" (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$ gpgeg de that the seeds wereknew the seeds were leakin 46s interpretation of
" iodine 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 a,I 3 N $ y n= red the inspection report which was reviewed by prepa s
n,Jy &.au w m =~ &m x m m p w n - m,n m m mm
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_wmaag 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
- h E
@$]M and the enforcement boart{adv sed that t NMSS.
was not a misadministration.
- However,
, advised that it
l 12 l
was.
(Exhibit S at 13, 14).
@Ydressthemisadministrationissue.\\ advised that the original inspection
$ $ Mj After reviewing an internal NMss document on misadministrations, discussing the incident with a
the the hospital and receiving assistance from headquarters, staf f determined that a physici n could change his diagnosis 92D5ERWJstated that af ter during the treatment process.
the staff concluded in the discussing the issue with t was not a misadministration inspection report that the inc (Exhibit 11 at 4, 5,
7, 8, 10).
[k stated that although 3 ultimately made the decision that a misadministration, M mistake was in not
'El e incident y{Ey af ter receiving conflicting in ormation from as going back to the NMSS staff (E it 5 at 14; 6 at 33 (fild - istated M init lally described 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 (Exhibit 5 which described various examples of misadministrations at 13, 6 at 32).
stated,gwas con % discussions with NMSS and the h
based on Wnced there was a medical decision to
- 1TEensee, that further stated that the doctorschangedtheprescriptionfo@rthebenefitofthepatient continue the patient's treatment.
the incident did not meet the misadministration and therefore, According to (( F l } the doctors could have changed the rule.
prescription at any time during the therapy and no matter when the decision occurred (i.e., at the beginning or end of the 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 N?.
W patient.
W2EDEMi$]$$B M EW WCi?!ML&W ~.
(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).
7 i
l had been developed r1 ater&)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 which had occurred at the university (Exhibit 13 at 6).
MM stated however, that Shad trouble " buying of f" on the 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).
PofficialOGCistated % did not viewfhl conversa ion vi
~have as an infon.
However, since as a wou 6-land to seek additional OGC adv ce after obtaining
' expected rom the staff (Exhibit 14).
differing y evs 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 staff would do so because they did not the licensee's favor.
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 1987, memorandum stated that the hospital advised they.
October 9, did not know the patient was the source of contamination during I
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 medical decision based on the' knowledge or suspicion that the 1
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
} commented that alth the hosp made continued..
it was made prior to letter.
this statement,
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).
pinion,theposita did not provide contradictory In after the wipe test, the 3
information.
According to 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
[ M acknowledged that the hospital's patient.
mad fter they know that one of the seeds representatIonswe had leaked.
Yet,,
s'
. stated that thought the incident was a misadministra on from "da one" ibit 3 at 16, 19; 4 at
%W never expressed this Accor: ling to@le opportunit to do so (Exhibi t-8, 10).
llE had amp view, althou 23).
also stated that it was and who that based on HMSS criter a, do tors cou initi y told.
prescription if they found an error during the decide to chang 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
~:
did not recall the conversation, but tggl$
conference call, ected in part:
" treatment of tumor was handwritten notes re continued for the best interest of the patient; NRC requested that the hospital put this in writing.
NRC will not consider ce the medical decision was to this a misadministrat s
vaguely recalled the a
stated that i continue treate 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 that the staff acted in bad faith or with malfeasance.
However, the 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 inquiry as to the facts which supported the chronolog The aff apparentiv did not focus on the medical decision.
advisedthatl E ssue and not wath-was primarily concerned with the contam nat.on l-whether or not the incident was a misadministration.
Because the 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 opinion after receiving conflicting opinions from NRC staff.
As 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 handwritten notes of October 30, 1984, may suggesk possible -
n 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."
([$35dk letter omitted specific information concerning when the hospital initially determined that the patient was the source of the contamination and when the ho ital made the medical decision.
As previously stated, ffE5 interpretation of the letter was that gg
" iodine leakage" referred to the leaking in the patient, hirts explanation that the " iodine leakage" referred to the gen 4ral contamination in the environment, and not the patient, occurred well af ter the allegations were made.
While the staf f had no apparent motive in reaching a determination that the incident was not a misadministration, there could have been legal ramifications for the hospital.
DETAILS - ALLEGATION f 2 b
hffinvestigationconcernIngth Region III conducted the OI hos.
tal's alleged 4
stated that after receiving misrepresentations to NRC.
the request for the investig tioni EW asked @RM vhether the m subseg ently advised M that patient was still alive. T@ ding to@h3DEdMe jcontact did the patient had died.
AcF6r not compromise the investigation (Exhibit 20 at 5, 6).
determine whether or not the patient (EYMG}contactg@m... Sto$about the iodine leakage and if was 1.isiing. Guag asked 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 obtain information concerning the pat:.ent.
Therefbre, R
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 )
on November 24, 1984.
The memorandum stated that tholospital 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 the medical dgelsion1984, $$ Iand $pe 28 or 29,
" met to discuss the iodine leakage"... and that "on August 29, 1984, wipe testing cf the patient's lead hat and bandage revealed no leakage, and it was decided not to remove the sources."
James SHIEZEK, Deputy Executive Director, Nuclear Regulations, Regional operations & Research was the final approving official before the EDO's signature.
SNIEZEK stated that he did not specifically recall discussing the memorandum with staff or whether the summary of events was attached prior to his concurrence.
SNIEZEK did not know that the information concerning the medical decision was inaccurate.
SNIEZEK stated the staf f ultimately concluded that the incident should have been a misadministration.
Therefore, the timing of the medical decision would not have altered or have made a difference with respect to the regulatory conclusion (Exhibit 23).
h@gls Mh f M E b b dEE EN$I3 d 3s @d$nating theE2d MSS, was responsible for coor
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 principally involved in areparing the EDO memorandum (Exhibit 24 at 4, 5,
and essentially made the presentation to the commissichers' FLU 7 12),
Assistants (Exhibit 5 at 26).
1986 Although the EDO memorandum referenced a November 24 telephone call with the[ Z @ f M g M M 7 Q bf { E 7 M,
f recall havIng a conversadon with ti stated that $ did no) Tf2 3 stated that @ did not ca)J and (Exhibit 25 at 31). g jy J
presumed Region III made the call (Exhibit 24 at 8,bd) stated that the only conversation k;7had was with 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 with the staff. [Ed C Q Q stated that the EDO occurred after the wipe t comorandum did not focus on th issue, nor did it specifically state when it occurred. W W acknowledged that th iefing paper did state when the ecision was made.
- However, 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).
h advised that the staff tried to explain the circumstances surrounding the incident and reasoning behind their decisions.
The 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 hosgi gd the information concerning the timing of According to @$1;sion[Q A g
was a result of the October 30, 1984, the medical de or Q~3 subsequent discussion with[h.
~;
conference call with that Q may have combined Q 5 N Q acknowledged however,
[GI$er with 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 at was discussed.
fA 9 W stated that definitely called
- once, however,theinv{dWfMTfondidnot e e'rmine whether there were additional calls.
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