ML20035E990

Forwards Summary of Misadministration & Therapeutic Misadministration Data for CY90-92.Analysis Based on Review of Insp Findings,Licensee Repts & Direct Communication W/ Licensee Detailed Breakdown of Data for Individual Incident

ML20035E990
Person / Time
Issue date:	04/14/1993
From:	Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Rogers, Selin, The Chairman NRC COMMISSION (OCM)
References
NUDOCS 9304200149
Download: ML20035E990 (13)

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Jg UNITED STATES

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E NUCLEAR REGULATORY COMMISSION Is WASHINGTON, D.C. 201154001 i

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April 14, 1993 MEMORANDUM FOR:

The Chairman Comissioner Rogers Commissioner Curtiss l

Comissioner Remick Comissioner de Planque FROM:

James M. Taylor Executive Director for Operations

SUBJECT:

EVALUATION OF THERAPEUTIC MISADMINISTRATION DATA FOR 1990-1992 l

l During a briefing to the Commission on January 22, 1993, the staff described i

the current practice for followup of patients subject to a therapeutic misadministration. The Commission questioned:

1) the extent of the Nuclear Regulatory Commission's confirmation of notification of the patient and/or i

referring physician of a misadministration; 2) the frequency of use of medical consultants for misadministrations; and 3) the underlying root causes of each misadministration.

Information responding to these questions has been obtained from the NRC regional offices and analyzed for therapeutic i

misadministrations involving NRC-licensed material for calendar years (CY) 1990 through 1992. A summary of the analysis is provided in Enclosure 1.

l A detailed breakdown of the data for individual incidents may be found in

{.

This analysis is based on a review of inspection findings, i

licensee reports, and in some cases, direct communication with the licensee if the report did not contain sufficient information. There was a change in the definition of misadministrations and notification requirements with the implementation of the " Quality Management Program and Misadministrations" (0M)

Rule, effective January 27, 1992. Regional personnel contacted licensees ac subsequently indicated that there was some confusion regarding the licensee's i

responsibility to send written notification to the patient, especially before implementation of the QM rule. The staff notes that many reasons given for not notifying the patient do not meet the criteria in 10 CFR 35.33(a)(3),

i.e., that in the medical judgment of the referring physician, telling the.

l patient would be harmful.

The data show that invalid reasons include:

" dose within acceptable limits;" "no adverse effects were expected;" "no medical benefit to the patient;" "not in the patient's best interest;" or that "the patient has died."

It should be noted that providing written notification has l

significantly improved, from 46 percent before January 27, 1992, to 76 percent j

after that date, which may reflect a change in the rule language regarding the requirement for the licensee to provide a written report to the patient.

l The root cause analysis was based primarily on a review of the licensee's written report and inspection findings. The four categories used are those described in the statements of consideration for the QM rule. Specifically, the root causes of misadministrations could be characterized primarily as 9304200149 930414 PDR COMMS NRCC CORRESPONDENCE PDR 1)Foa.

J11

I l

!:.4 The Commissioners 2

l deficient procedures or failure to follow procedures, inattention to detail, and inadequate training. Some misadministrations were a result of more than one of these causes. Although the regions did not identify insufficient supervision as a root cause of any misadministration, inadequate supervision was a likely contributing cause in many instances where failure to follow procedures or inadequate training were involved.

The staff is currently preparing an Information Notice for all NRC medical licensees, reemphasizing the importance of the requirements for notifications, reports, and records of misadministrations in 10 CFR 35.33. This notice will point out that many reasons given for not notifying the patient do not meet i

the criteria in 10 CFR 35.33, i.e., that, based on the medical judgment of the referring physician, telling the patient would be harmful.

In addition, the notice emphasizes that there is no basis for the belief that the misadministration notification requirements cease upon the death of a patient.

Licensees are advised that if there is any confusion as to the identity of the i

patient's " responsible relative," licensees have the responsibility to identify that person. A memorandum was sent to all NRC regions on April 5, 1993, addressing the importance of ensuring that the licensee has complied with all requirements in 10 CFR 35.33, including patient notification after a misadministration.

Furthermore, the staff is currently reviewing the cases wherein the patient was not provided with a written notification to determine if enforcement action is warranted.

g)gned by p g.TWC' James M. Taylor Executive Director for Operations

Enclosures:

cc:

1.

Summary of Misadministration SECY data fr CY90-92 OGC 2.

Therapeutic Misadministration OPA data fr CY90-92 OCA DISTRIBUTION:

IMAB1232 NRC File Ctr IMNS Central File NMSS Dir0f r/f IMAB r/f EJordan, AEOD JMPiccone PRathbun BHayes, 01

( ), [ p,3 TechEd EDO R/F JLieberman, OE

,'i EKraus Taylor M

02/25/93 Thompson O

• See previous concurrence OFC IMAB E

IMAB*

t IMAB*

N D/IMNS*

NAME PKHolahan LWCamper JEGlenn RECunningham DATE 03/ /93 03/05/93 03/05/93 03/08/93 DD NMSS,

D/NMSN DEDS

/

EDO 0FC

• 0GC

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NAME STreby GArktko RMB h o HThompIon M or DATE 04/08/93

/0k6/93 h//993 OJ/ l f/93 h//93 f

0FFICIAL RECORD COPY /G:\\lMAB1232 C= COVER E=C& ENCL. N=NO COPY

SUMMARY

OF THERAPEUTIC MISADMINISTRATION DATA FOR NRC LICENSEES DURING 1990 - 1992 Number of Percentage occurrences Notification of referring physician 70'/72 97 within 24 hr Verbal notification of patient or 52,s/72 72 2

relative Written notification provided to 29'/52 56 5

patient (if informed verbally)

Medical consultant used 23/72 32 Root cause analysis':

1.

Insufficient supervision 0/72 0

2.

Deficient procedures or failure 29/72 40 to follow procedures 3.

Inattention to detail 31/72 43 4.

Inadeguatetraining 11/72 15 5.

Other 9/72 12 4

' In two of these cases, notification was not within 24 hr; notification is unknown in one of two cases; in one other of the two where the referring physician was not notified, the patient was notified verbally.

2 In 50/52 cases, notification was made within 24 hr; in 7/20 cases, the referring physician made a medical judgment that informing the patient would be harmful.

In 2/20 cases when the patient was not informed, the patient died prior to determination that a misadministration occurred; in 4/20 cases, no i

reason was provided; and in the remaining 7/20 cases, the reasons included:

no adurse effects expected; not in patient's best interest; or the dose was within acceptable clinical limits.

3 In 1/52 risadministrations, 12 patients were involved. Only one of these patients was not notified because the physician believed it would result in undue patient stress.

l

' In 2 of the remaining 23 cases, it is unknown if the patient received a written report.

For the 21 cases in which the patient did not receive written notification, the primary reason provided by the licensee was a lack of undentanding of the requirement.

5 It should be noted that after January 27, 1992, 76 percent of the patients that were informed verbally also received written notification.

' Some misadministrations may have been attributed to more than one root cause so that the summed percentage exceeds 100 percent.

7 Other reasons included lack of management oversight, recordkeeping, technical problems, and patient intervention.

THERAPEUTIC NISADMINISTRATION DATA FOR NRC LICENSEES DURIM 1990 - 1992 FACILITY TYPE' ROOT CAUSE NOTIFICATION' WITTEN MEDICAL CONSULTANT FIMIMS COMENTS I

(DATE)

PHYSICIAN PATIENT NOTIFICATION CONSULTANT Ball Memorial B

5-Kink in Y

Y N

Hospital Catheter -

hse to any (2-6-90) significant structure not of clinical significance Berkshire Medical T

3 y

Y N

N Cent:r (11-91)

Beth Israel B

5-Lack of N

N' N

Hospital Ngat,RSC,RSO NRC identified during (8-23-90) oversight 92' inspection

• Itcensee did not consider a misadmin.

- patient died before NRC identified Bothwell Regional T

2 Y

Y Y

M Hospital (3-18-92)

Brigham & Women's R

3 y

y V

N Hospital (7-19-90)

Carlisle Hospital T

4 y

V N

N (1-13-92)

Christ Hospital B

5-difficulty Y

Y N

Y low probability of (5-29-92) with new technology damage to rectal tissues-greater risk of tumor recurrence i

e i

4

(

FACILITY TYPE' ROOT CAUSE NOTIFICATION

• WITTEN NEDICAL CONSULTANT FININGS COM 0fTS 2

l (DATE)

PHYSICIAN PATIENT NOTIFICATION CONSULTANT Clara Maass R

2 Y

Y N

Y

-No significant Medical Center (3-28-91) effect - rapid clearance Cleveland Clinic T

2 Y

N N

b 6

Foundation

-misadmin. only in (2-6-90) technical sense - not relevant to pt. care C1 veland Clinic 8

3 Y

Y Y

N Foundition (4-24-91)

Cisveland Clinic-8 2

Y Y

N Y

No evidence of acute Foundation (1-17-92) adverse reactions Cooper Hosp / Univ.

8 3

Y M*

N Medical Center

• dose within (1-24-92) acceptable clinical Ilmits Cooper Hosp / Univ.

8 2

Y N

Y No adverse effects d

~

Medical Center

-no adverse effects, (9-17-90) did not want extra patient stress Frankferd Hospital R

3 Y

Y N

N (8-1-90)

Geisinger Medical T

2 Y

Y (not N (7)

Y Some risk of Center in 24 radiation myelitis 6-(2-19-90) hr) 24 mos.; possible 5

spinal cord leston.

Gelsinger Medical R

5 (dose was N (?)*

N' N

Hospital off)

• Questionable (7-25-91) misadministration 2

4 4

1 4

i

FACILITY TYPE' ROOT CAUSE NOTIFICATION' WRITTEN NEDICAL CONSULTANT FINDINGS CONNENTS 2

(DATE)

PHYSICIAN PATIENT NOTIFICATION CONSULTANT Greenwich Hospital T

3 Y

N' N

' based on medical (10-22-92) judgement Hahnemann B

3 Y

N' N

'-medical judgement Univ!rsity that administration (2-22-91) within clinical parameters - no adverse effects Harper Hospital T

2 Y

N" N

• may cause patient (2-24-92) unhealthy increase in anxiety Hospital B

, 2, 3 Y

Y Y

Y(INEL)

Metrtpolitano

, 5-(3-24-92) recordkeeping Indiana Univ T

3 Y

Y Y

Y no significant School of Medicine deleterious medical (5-14-90) effects expected Indiana Univ T

2 Y

Y Y

Y School cf Medicine (11-13-92)

Jane Phillips T

3, 4 Y

Y Y

N Episccp:1-Memorial Medical Center (10-29-92) 3

FACILITY TYPE' ROOT CAUSE NOTIFICATION' WRITTEN MEDICAL CONSULTANT FINDINGS COMMENTS 2

(DATE)

PHYSICIAN PATIENT NOTIFICATION CONSULTANT J;rs:y Shore T

2 Y

N' H

' not in patient's Hospital (11-3-92) best interest John F. Kennedy 8

4 Y

Y Y

Y Kerato-conjunctivitis Memorial Hospital (3-16-90)

(may have been viral-induced)

L:h y Clinic B

3 Y

Y (not N

N F;undation in 24 (10-14-92) hrs)

Massachusetts T

2 Y

N3 N

Gen:ral Hospital 3-not in patient's (7-15-92) best interest Medical Center of T

2 Y

Y Y

N Delaware (8-11-92)

Medical Center T

3 Y

Y Y

N Hospital Vermont (1-31-92)

Memorial Hospital B

2, 4 Y

N' cf Laramie County Y (INEL)

• based on medical (10-22-92) judgement, telling patient would be harmful Monog: hela Valley B

2 Y

Y N

Y No adverse effects Hospital (1-17-90) expected 4

FACILITY TYPE' ROOT CAUSE NOTIFICATION

• NRITTEN NEDICAL CONSULTANT FilWINGS CONNDITS 3

(DATE)

PHYSICIAN PATIENT NOTIFICATION CONSULTANT Muskogee Regional T

3 Y

N' Medical Center N

' based on medical (3-12-90) judgement, telling patient would be harmful.

Ohio State B

4 Y

Y Y

N Univ:rsity (11-13-91)

Oncology Services B

4 Y

Y Y

Y Radiation was a Ctrporation (11-18-92) contributing cause of death i

Parkview Memorial 8

5 - patient Y

?

N Hospital intervention (3-21-90)

Que:n's Medical B

5-bend in Y

Y Y

N Ccntcr catheter (2-12-92)

Radiology-T 3

Y Y

Y N

Ultrasound-Nuclear Consultants (2-28-92)

Riv:rside R

3 Y

Y N

N Methodist Hospital (8-2-91)

Rivtrside Regional T

4 Y

Y Y

N Nedical Center (3-16-90) i 5

1

FACILITY TYPE' ROOT CAUSE NOTIFICATION' WRITTEN MEDICAL CONSULTANT FINDINGS CONMENTS 2

(DATE)

PHYSICIAN PATIENT NOTIFICATION CONSULTANT St. Clares 8

4 Y

Y N

Y RivIrside Medical Center (10-2-92)

St. Francis R

3 Y

Y N

N Medical Center (4-17-90)

St. John Medical T

4 Y

Y Y

Y (INEL)

C:ntcr (1-13-92)

St. John's T

3 Y

Y" N

N Regi nal Medical 5 - wedge

- 12 patients

" l patient not Ccnter factor not (4-11-91) used notified because of undue patient anxiety St. John's Medical T

2 Y

Y Y

Y (2)"

5% risk of radiation

" reevaluation by Centar (11-6-92) neurosis in 4-12 second consultant months St. J:seph's B

2 Y

Y N

N Hospital / Medical Center (10-25-91)

St. Jos:ph's 2

Y Y

N N

' Hospital / Medical C nttr (7-16-92)

St. J s:ph's B

2 Y

Y Y

N Hospital (9-19-91) 4 6

i

FACILITY TYPE' ROOT CAUSE' NOTIFICATION NRITTEN NEDICAL CONSULTANT FINDINGS CONNENTS S

(OATE)

PHYSICIAN PATIENT NOTIFICATION CONSULTANT St. Lukes Hospital T.

3 Y

Y N

N (5-7-90)

St. Lukes Hospital T

3 Y

Y N

N (6-22-90)

St. Nary's Medical T

2 Y

Y Y

Y low probability of Ctnter (3-19-90) radiation necrosis of thoracic spine in 6 mos. - 4 yrs.

St. Vincent Health R

2 Y

Y N'

N

• physician received Ccnter

_(7-10-90) written report Sc:tt AFB, USAF R

3 Y

Y Y

N (7-18-91)

Sharlin Radiology T

3 Y

Y Y

N Associates-(11-13-92)

Triplcr Army B

2,3,4 Y (10 N'

N Medical Center days

-identified during QA (10-16-87) late) audit on 4/24/91

-unaware of reporting requirements

'-patient died 2/11/90 Univ;rsity Hosp B

5-patient' Y

Y Y

N cf Cleveland intervention (5-31-91)

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l FACILITY TYPE' ROOT CAUSE*

NOTIFICATION WRITTEN NEDICAL CONSULTANT FININGS CONNENTS 3

(DATE)

PHYSICIAN PATIENT NOTIFICATION-CONSULTANT Univ rsity of 3

5-difficulty V

Y Y

N Cincinnati with new (8-30-90) technology Univ rsity of T

2 Y

Y Y

N CT Hesith Center (8-4-92)

Univ Pittsburgh T

3 Y

Y Y

N Prssbyterian Hospital (9-14-90)

Univ Pittsburgh T

3 Y

Y N

N Prosbyterian Hospital (11-21-91)

Univ Pittsburgh B

3 Y

Y N

N Presbyterian Hospital (6-26-91)'

Univsrsity of 8

3 Y

Y Y

Y

-no significant Wiscensin-Madison medical (2-7-90) consequences Univ:rsity of 8

3 Y

Y

? - patient Y

-no significant Wisconsin-Nadison deceased

.(3-15-90) medical consequences Univ rsity of 8

2 Y

Y Y

Y

-no s19nificant Wiscensin (11-27-91) reaction expected 1

l i

i 1

l

FACILITY TYPE' ROOT CAUSE NOTIFICATION' WRITTEN NEDICAL CONSULTANT FIleINGS CONNDITS 3

(DATE)

PHYSICIAN PATIENT NOTIFICATION CONSULTANT VA Loma Linda R

(authorized Y

N' N

-0GC determined (12-9-90) user)

(11/92) misadministration -

referring physician notifed 11/92

"- no adverse effects observed in 5/92 Valley Hospital R

2 Y

A - N' Y

-no adverse effects

-2 patients-involved (6-4-90) 8-?

expected

' not notified b/c no

-1 patient had adverse effects - no decreased WBC, medical benefit to platelets inform Washington T

2 Y

N' N

• physician did not Hospital Ce.i;er feel appropriate (1-16-9)n Washington T

2 Y

Y N

N Hospital Center (2-5-91)

West Virginia B

2 Y

N' N

' knowledge of lower Univ. Hospital dose might decrease (5-28-91) palliative effect William Beaumont R

3 Y

Y Y

Y

-no adverse medical Hospital effects expected (10-10-90)

William Beaumont R

3 Y-N" N

"-based on medical Army Ned Center judgement, telling (8 30-91) patient would be harmful 9

4 6

.0

.,_-....._...m.

FACILITY TYPE' ROOT CAUSE NOTIFICATION WRITTEM MEDICAL CONSULTANT FINDINGS COMMENTS 3

3 (DATE)

PHYSICIAN PATIENT NOTIFICATION CONSULTANT Yalo New Haven B

2 Y

Y Y

Y

-no report yet.

Hospital (12-2-92)

Yalo New Haven B

3 Y

N' N

' not in patient's Hospital best interest (7-5-91) 1.

Type of misadministration: T - teletherapy; B - brachytherapy; R - radiopharmaceutical therapy 2.

Root cause was attributed to 5 general categories: 1) insufficient supervision; 2) deficient procedures or failure to follow procedures;

3) inattention to detail; 4) Inadequate training; and/or 5) other.

3.

Y - yes; N - no.

In those instances where the licensee provided a reason for not informing the patient, the licensee's reason is indicated under Comments. This does not infer that these reasons meet the criteria in 10 CFR 35.33, i.e., 62.t based on the medical judgment of the ref;rring physician, telling the patient would be harmful.

10

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