ML20236Q171
| ML20236Q171 | |
| Person / Time | |
|---|---|
| Issue date: | 07/13/1998 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Combs F NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20236Q149 | List: |
| References | |
| SSD, NUDOCS 9807200044 | |
| Download: ML20236Q171 (23) | |
Text
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f e.
.b From Steven Baggett To: TWD2.TWP8.FCC, TWD2.TWP8.JMP1, TWD2.TWP8.KMR, TWD2...
Dates- 7/13/98 10:38r.m Subjects GAP issue Drat 7089 Our effort to do an IN regarding root causes of misadminstrations involving I-131 capsules warrants a change in direction as originally given by GAP.
Please note MSB obtained the background and files that were to be the bases l
for the IN'and have determined that a NMSS newsletter article and not an IN should be issued. I'm having the newsletter article drafted for the next edition. If GAP disagrees with the change from IN to newsletter article, please advise and I will be willing to explain further.
Thanks DR m
e lD l.
PATIENTS RECEIVED LESS THAN PRESCRIBED DOSAGE WHEN ONE OF TWO l-131 CAPSULES WERE NOT ADMINISTERED A medical misadministration occurred at the Edward Hospital in Naperville, Illinois, when a l patient was given less than the prescribed dose. A patient was to have been given 150 mci of I-131 sodium iodide in two capscles on May 21,1998. However, on June 6,1998, it was discovered that the patient was only administered one capsule. The second capsule was founr1 still in the shipping container.
Another misadministration occurred at the Rhocie Island Hospitalin Providence on June 3, 1998. A patient was administered only 7 mci of a prescribed 10 mci dose of I-131, because only one 7 mci capsule of a two capsule dose was administered. The other capsule (3 mci) was found during an inventory suntey of the hot lab on June 17,1998.
There is a concern that nuclear medicine technologists are erroneously assuming that the prescribed 1-131 dose is contained in only one capsule, when it may have been placed in multiple capsules. Based on review of ten misadministration, the U.S. Nuclear Regulatory Commission suggests licensees who administer 1-131 capsules review their protocol and training, ar.d take action appropriately.
Contact:
Eric Compton, NMSS (301) 415-5799 email : ebc@nrc. gov l
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ETS DATA ENTRY FORM Revised 6/1/1998 Assigned / Referred To: IMNS Assignment (Report) Date: 6/10/1998 Licensee / Vendor: EDWARD HOSPITAL EN Number: 34380 Event Date: ,6T67I998]
MR Number: [0 Event Type: NMS; PN Number; j-98-033 J Specialty Code: l Accession No: :0 l (80 = TAR,84 = P21 Report)
Other Report No: { ]
EVENT / CONDITION DESCRIPTION (descriptive title):
Medical Misadministration: Patient received less than two thirds of prescribed dose when one of two capsules are not administered (150 mci 1-131 prescribed, 51 mci administered)
CLOSEOUT TEXT:
Safety Significance: __, Other _EOl _, ,_SIG _AO l l Candidate for Op Events Briefing?: _No .__Yes, Briefing No.__ _(YY-MM)
Generic Follow-up Recommended: __, No __Yes
,,,IN _BUL _GL _OTHER (specify below) ;
I Generic Safety issue: No Yes (refer to RES for tracking) l Status Due Date: ,J._ f_ (TAR due date, insp. report target dats, etc.)
RC INFORMATION:
GAP MEETING NOTES:
~
Initial Screening Date: [11/T5i8 ] (Regional Coordinator Briefing) .
Final Screening Date: ,6/16/1999 j (Generic Assessment Panet Review) j Closeout Date: [/.-/l pc, ,p' ,
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q ETS DATA ENTRY FORM Revised 611/1998 LicenseeNendor: EDWARD HOSPITAL Facility: EDWARD HOSPITAL NAPERVILLE IL Event Notification Text: EN Number: 34380 Other Rep. No: 0 A MEDICAL MISADMINISTRATION OCCURRED AT THE EDWARD HOSPITAL IN NAPERVILLE, ILLINOIS, WHEN A PATIENT WAS GIVEN LESS THAN THE PRESCRIBED DOSE.
A PATIENT WAS TO HAVE BEEN GIVEN 150 mci OF l-131 SODIUM IODIDE IN TWO CAPSULES ON 05/21/98. HOWEVER, ON 06/06/98, IT WAS UlSCOVERED THAT THE PATIENT WAS ONLY ADMINISTERED ONE CAPSULE SINCE THE SECOND CAPSUL F WAS FOUND STILL IN THE SHIPPING CONTAINER. THE CAPSULE 1NAS ASSAYED AT 25.5 mCl, WHICH WOULD HAVE BEEN CLOSE TO 102 mci AT THE TIME IT SHOULD HAVE BEEN ADMINISTERED. SINCE THE VIAL WITH BOTH CAPSULES WAS ASSAYED TO BE 153 mci, THE ADMINISTERED DOSAGE WAS ONLY 51 mci, LESS THAN HALF OF THE PRESCRIBED DOSAGE.
THE REFERRING AND SUPERVISING PHYSICIANS WERE NOTIFIED. THE PATIENT WILL BE NOTIFIED.
NOTE: THIS EVENT NOTIFICATION WAS RECElVED IN THE NRC OPERATIONS CENTER FROM THE NRC OFFICE OF STATE PROGRAMS (HSUEH) WHO HAD RECEIVED IT FROM THE ILLINOIS DEPARTMENT OF NUCLEAR SAFETY VIA FACSIMILE.
Preliminary Notification Text: PN Number: 3-98-033 The lilinois Department of Nuclear Safety (IDNS) reported to NRC that a medical misadministration was identified at Edward Hospital, Naperville, IL on June 6,1998. (EN 34380) An 18 year-old female patient was prescribed to receive 150 millicuries (5.6 GBq) of iodine- 131 in two sodium iodide capsules. One of the two capsules was administered to the patient on May 21,1998. On June 6,1998, the licensee discovered the second capsule, still in the shipping container, it was determined that the administered dosage of iodine-131 was 51 millicuries (1.9 GBq) from the first capsule, less than the prescribed 150 millicurie (5.6 GBq) dosage.
The supervising and referring physicians were notified of the misadministration. A 15-day written report is required to be sent to IDNS confirming that the patient was notified and describing what follow-up medical treatment is planned. The report is also to describe the licensee's investigation results and corrective actions.
The Region til State Agreements Officer is monitoring tne State's investigation.
IDNS notified the NRO Office of State Programs of this misadministration on June 10,1998. This information is current as of 11:00 a.m. (CDT) on
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June 11, 1998 PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURF.ENCE PNO-III-98-033 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by Region III staff (Lisle, Illinois) on this date.
Facility Lipensee Emercency Classification Edward Hospital Notification of Unusual Event Edward Hospital Alert Naperville, Illinois Site Area Emergency License No: IL-01232-01 General Emergency X Not Applicable
Subject:
RADIOPHARMACEUTICAL MISADMINISTRATION (UNDERDOSE)
The Illinois Department of Nuclear Safety (IDNS) reported to NRC that a medical misadministration was identified at Edward Hospital, Naperville, IL on June 6, 1998. (EN 34380) An 18 year-old female patient was prescribed to receive 150 millicuries (5.6 GBq) of iodine- 131 in two sodium iodide capsules. One of the two capsules was administered to the patient on May 21, 1998. On June 6, 1998, the licensee discovered the second capsule, still in the shipping container. It was determined that the administered dosage of iodine-131 was 51 millicuries (1.9 GBq) from the first capsule, less than the prescribed 150 millicurie (5.6 GBq) dosage.
The supervising and referring physicians were notified of the misadministration. A 15-day written report is required to be sent to IDNS confirming that the patient was notified and describing what follow-up medical treatment is planned. The report is also to describe the licensee's investigation results and corrective actions.
The Region III State Agreements Officer is monitoring the State's investigation.
IDNS notified the NRC Office of State Programs of this misadministration on June 10, 1998. This information is current as of 11:00 a.m. (CDT) on June 11, 1998.
Contact:
JIM LYNCH ROLAND LICKUS (630)829-9661 (630)829-9660
1 4
HOSPITAL EVENT NUMBER: 34380 LICENSEE: EDWARD HOSPITAL NOTIFICATION DATE: 06/10/98 CITY: NAPERVILLE REGION: 3 NOTIFICATION TIME: 16:55 [ET)
COUNTY: STATE: IL EVENT DATE: 06/06/98 LICENSE #: IL-01232-01 AGREEMENT: Y EVENT TIME: : [CDT]
DOCKET: LAST UPDATE DATE: 06/10/98 NOTIFICATIONS JIM MCCORMICK-BARGER RDO JOE HOLONICH, NMSS EO NRC NOTIFIED BY: SANZA-IL. DEPT NUC SAFETY HQ OPS OFFICER: CHAUNCEY GOULD EMERGENCY CLASS: NOT APPLICABLE 10 CFR SECTION:
NAGR AGREEMENT STATE LADM 3 5. 3 3 (a) MED MISADMINISTRATION l
EVENT TEXT A MEDICAL MISADMINISTRATION OCCURRED AT THE EDWARD HOSPITAL IN NAPERVILLE, ILLINOIS, WHEN A PATIENT WAS GIVEN LESS THAN THE PRESCRIBED DOSE.
A PATIENT WAS TO HAVE BEEN GIVEN 150 mci OF I-131 SODIUM IODIDE IN TWO CAPSULES ON 05/21/98. HOWEVER, ON 06/06/98, IT WAS DISCOVERED THAT THE PATIENT WAS ONLY ADMINISTERED ONE CAPSULE SINCE THE SECOND CAPSULE WAS FOUND STILL IN THE SHIPPING CONTAINER. THE CAPSULE WAS ASSAYED AT 25.5 mci, WHICH WOULD HAVE BEEN CLOSE TO 102 mci AT THE TIME IT SHOULD HAVE BEEN ADMINISTERED. SINCE THE VIAL WITH BOTH CAPSULES WAS ASSAYED TO BE 153 mci, THE ADMINISTERED DOSAGE WAS ONLY 51 mci, LESS THAN HALF OF THE PRESCRIBED DOSAGE.
THE REFERRING AND SUPERVISING PHYSICIANS WERE NOTIFIED. THE PATIENT WILL BE NOTIFIED.
NOTE: THIS EVENT NOTIFICATION WAS RECEIVED IN THE NRC OPERATIONS CENTER FROM THE NRC OFFICE OF STATE PROGRAMS (HSUEH) WHO HAD RECEIVED IT FROM THE ILLINOIS DEPARTMENT OF NUCLEAR SAFETY VIA FACSIMILE.
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ETS DATA ENTRY FORM Revised 6/1/1998 Assigned / Referred To: IMNS Assignment (Report) Date: 6/18/1998 LicenseeNendor: RHODE ISLAND HOSPITAL
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EN Number: ~2414 3 Event Date: 6/3/1698 _
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MR Number: ld Event Type: NMS PN Number: 0 .
Specialty Code:
Accession No: 0 R (80 = TAR,84 = P21 Report)
Other Report No: 0 ,
j EVENT / CONDITION DESCRIPTION (descriptive title):
Medical Misadministration: Patient administered only 7 mci of a prescribed 10 mci dose of i 131, because only one capsule (7 mci) of a two capsule dose was administered CLOSEOUT TEXT:
Safety Significance: Other EOl SIG AO i Candidate for Op Events Briefing?: _No __Yes, Briefing No. _ __ (YY-MM)
Generic Follow-up Recommended: No Yes
__lN _BUL __GL __OTHER (specify below)
Generic Safety issue: __No _Yes (refer to RES for tracking)
I Status Due Date: I I (TAR due date, insp. report target date, etc.)
RC INFORMATION:
GAP MEETING NOTES:
initial Screening Date: '6] 9/1998 (Regional Coordinator Briefing)
Final Screening Date: _6/23/1998_ (Generic Assessment Panel Review)
- l. _
Closecut Date: {I]T]
I. .
a ETS DATA ENTRY FORM Revised 6/1/1998 LicenseeNendor: RHODE ISLAND HOSPITAL Facility: RHODE ISLAND HOSPITAL PROVIDENCE Ri Event Notification Text: EN Number: 34414 Other Rep. No: 0
- MEDICAL MISADMINISTRATION EVENT-CHARLES McMAHON, RHODE ISLAND DEPARTMENT OF HEALTH, OFFICE OF OCCUPATIONAL & RADIOLOGICAL HEALTH, REPORTED BY FAX THAT A PATIENT IN RHODE ISLAND HOSPITAL, PROVIDENCE, RI, WAS ADMINISTERED ONLY 7 mci OF A PRESCRIBED 10 mci DOSE OF l 131, BECAUSE ONLY ONE 7 mci CAPSULE OF A TWO CAPSULE DOSE WAS ADMINISTERED. THE OTHER CAPSULE (3 mci) WAS "FOUND" DURING AN INVENTORY OR SURVEY OF THE HOT LAB ON 06/17/98.
MR McMAHON PLANS TO PROVIDE ADDITIONAL INi ORMATION TO THE NRC WHEN MORE DETAILED INFORMATION BECOMES AVAILABLE.
Preliminary Notification Text: PN Number: 0 Morning Report Text: MR Number: 0 l
HOSPITAL EVENT NUMBER: 34414 LICENSEE: RHODE ISLAND HOSPITAL NOTIFICATION DATE: 06/18/98 CITY: PROVIDENCE REGION: 1 NOTIFICATION TIME: 16:04 [ET)
COUNTY: STATE: RI EVENT DATE: 06/03/98 )
LICENSE #: 7D-051-01 AGREEMENT: Y EVENT TIME: 12:00[EDT)
DOCKET: LAST UPDATE DATE: 06/18/98 NOTIFICATIONS HERB WILLIAMS RDO NRC NOTIFIED BY: CHARLES McMAHON (BY FAX)
HQ OPS OFFICER: DICK JOLLIFFE EMERGENCY CLASS: NOT APPLICABLE 10 CFR SECTION:
LADM 3 5. 3 3 (a) MED MISADMINISTRATION EVENT TEXT
- MEDICAL MISADMINISTRATION EVENT -
CHARLES McMAHON, RHODE ISLAND DEPARTMENT OF HEALTH, OFFICE OF OCCUPATIONAL
& RADIOLOGICAL HEALTH, REPORTED BY FAX THAT A PATIENT IN RHODE ISLAND HOSPITAL, PROVIDENCE, RI, WAS ADMINISTERED ONLY 7 mci OF A PRESCRIBED 10 mci DOSE OF I-131, BECAUSE ONLY ONE 7 mci CAPSULE OF A TWO CAPSULE DOSE WAS ADMINISTERED. THE OTHER CAPSULE (3 mci) WAS "FOUND" DURING AN INVENTORY OR SURVEY OF THE HOT LAB ON 06/17/98.
MR McMAHON PLANS TO PROVIDE ADDITIONAL INFORMATION TO THE NRC WHEN MORE DETAILED INFORMATION BECOMES AVAILABLE.
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PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO-Ill-97-090 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by the Region ill staff on this date.
Facility Licensee Emergency Classification Mclaren Regional Medical Center Notification of Unusual Event Mclaren Regional Medical Center Alert Flint, Michigan Site Area Emergency License No: 21-04171-04 General Emergency X Not Applicable
Subject:
REPORT OF RADIOPHARMACEUTICAL MISADMINISTRATION On November 11,1997, the licensee's consultant notified the NRC of a misadministration of iodine-131 (1-131) that the licensee identified as having occurred on November 10,1997. A patient was scheduled to receive 296 MBq (8 millicuries) of I-131 for treatment of a hyperthyroid condition. A vial containing two capsules of I-131 was given to the patient to be administered orally. After the patient left the medical center, it was discovered that one of the capsules was still remaining in the vial with a measured activity of 129.5 MBq (3.5 millicuries).
According to the licensee, the nuclear medicine technologist responsible for the administration stated that she had assayed the capsule twice and the indicated activity was 292.3 MBq (7.9 millicuries).
Upon further review, shipping papers indicated the total activity of the 1-131 to be 299.7 MBq (8.1 millicuries). The licensee contacted the vendor to verify the shipment. The vendor indicated that two capsules had been shipped with activities of 170.2 MBq (4.6 millicuries) and 129.5 MBq (3.5 millicuries), therefore the patient received an administration of I-131 of only 170.2 MBq (4.6 millicuries).
The licensee contacted the patient, who returned to the medical center on
~
l November 12,1997, and was administered the second capsule. The
- misadministration had no adverse affect on the patient.
NMSS and the State of Michigan were notified of the misadministration.
The information in this preliminary notification has been reviewed with the licensee.
Region lil will conduct a special inspection during the week of November 17,1997, to review the circumstances of the misadministration.
The hospital reported this event to the NRC Operations Center at 3:11
p.m. (EST) on November 11,1997. This information is current as of 1 p.m.
on November 12,1997.
Contact:
JAMNES CAMERON BOB HAYS (630)829-9833 (630)829-9819
LICENSEE: MCLAREN REGIONAL MEDICAL CENTER SITE: MCLAREN REGIONAL MEDICAL CENTE EN NUMBER:33247 DOCKET: EVENT DATE: 11-10-97 RX TYPE: EVENT TIME: 10:15 VENDORS: NOTIFY DATE: 11-11-97 EMERGENCY CLASS: N/A REGION: 3 STATE: Ml TIME: 15:11 OPS OFFICPi: JOHN MacKINNON 10 CFR SEC.:ON: LADM 35.33(a) MED MISADMINISTRATION PATIENT GIVEN 4.6 mci OF IODINE-131 INSTEAD OF 8.0 mci.
A CONSULTING MEDICAL PHYSICIST FOR THE McLAREN REGIONAL MEDICAL CENTER LOCATED IN FLINT, MICHIGAN, GAVE THE FOLLOWING REPORT:
A PATIENT WAS TO HAVE RECEIVED 8 mci OF IODINE-131 FOR A HYPERTHYROID CONDITION. A VIAL CONTAINING TWO CAPSULES WAS GIVEN TO THE PATIENT. AFTER THE PATIENT LEFT THE MEDICAL CENTER, IT WAS DISCOVERED THAT ONE CAPSULE REMAINED IN THE VIAL. THE TECHNICIAN ASSIGNED TO ADMINISTER THE LODINE-131 SAID THAT SHE HAD ASSAYED THE CAPSULE TWICE BEFORE GIVING THE PATIENT THE CAPSULE (THE MEASURED IODINE-131 ACTIVITY OF THE CAPSULE WAS 7.9 mci). THE SHIPPING PAPERS FOR THE VIAL INDICATED THAT THE TOTAL ACTIVITY OF THE TWO CAPSULES IN THE VIAL WAS 8.1 mci. THE LICENSEE CALLED THE MANUFACTURER (BRACCO DIAGNOSTIC LOCATED IN PRINCETON, NEW JERSEY)
AND ASKED THEM TO CHECK THEIR RECORDS TO FIND OUT THE ACTIVITY OF EACH CAPSULE IN THE VIAL THAT HAD BEEN SHIPPED TO THEM. BRACCO DIAGNOSTIC CHECKED THEIR SHIPPING PAPERS AND INVENTORY AND INFORMED McLAREN REGIONAL MEDICAL CENTER TODAY (11/11/97) THAT THE TOTAL ACTIVITY OF THE TWO CAPSULES WAS 8.1 mci. ONE CAPSULE CONTAINED 4.6 mci OF LODINE-131 AND THE OTHER CAPSULE IN THE VIAL CONTAINED 3.5 mci OF IODINE-131. THE LICENSEE CHECKED THE ACTIVITY OF THE REMAINING CAPSULE IN THE VIAL AND FOUND THAT IT CONTAINED 3.5 mci OF IODINE-131. THEREFORE, THE PATIENT HAD RECElVED 4.6 mci OF IODINE-13i iiGTEAD OF 8.0 mci OF IODINE-131.
THE LICENSEE HAS BEEN TRYING TO CONTACT THE PATIENT BUT AT THE PRESENT TIME THEY HAVE NOT BEEN ABLE TO REACH THE PATIENT. THE PATIENTS' PHYSICIAN HAS BEEN NOTIFIED OF THE MEDICAL MISADMINISTRATION. THE PATIENT WILL BE ASKED TO RETURN TO McLAREN REGIONAL MEDICAL CENTER TO RECEIVE THE REMAINING 3.5 mci OF IODINE-131. THIS MEDICAL MISADMINISTRATION HAS NO ADVERSE AFFECT ON THE PATIENT.
t I- - - - - --- - - - - - - - - - - - - _ - - - - _____ -
PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO-ill-97-039 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by the Region lll staff on this date.
Facility Licensee Emergency Classification Theda Clark Hospital Notification of Unusual Event Theda Clark Hospital Alert Neenah, Wisconsin Site Area Emergency License No: 48-09494-01 General Emergency X Not Applicable
Subject:
MISADMINISTRATION - UNDERDOSAGE IN IODINE-131 TREATMENT On May 1,1997, the licensee discovered that a patient being treated for a thyroid disorder received an underdosage of iodine-131 on December 20, 1996. The patient was to receive 9.4 millicuries of sodium iodide, iodine-131, in the form of two capsules, each containing 4.7 millicuries.
The licensee measured the dosage of the two capsules prior to administration, and provided them to the patient in a lead-shielded vial.
One of the capsules apparently lodged in the vial, and the patient took only one capsule.
The vial was returned to the laboratory of the licensee's Nuclear Medicine Department for storage. On May 1,1997, nuclear medicine department personnel discovered that the vial still contained a capsule while reorganizing its laboratory. The licensee concluded that the patient was administered 50 percent of the prescribed dosage because the second capsule remained in the vial.
The licensee has notified the referring physician, who plans to notify l
the patient on May 2,1997. The case is being reviewed for appropriate medical followup by the licensee.
NRC Region lli (Chicago) will perform a special inspection during the week of May 5,1997, to review the circumstances surrounding the reported misadministration.
L The State of Wisconsin has been informed. The information in this preliminary notification has been reviewed with the licensee's Radiation Safety Officer.
The licensee notified the NRC Operations Center of this event at 3:25 l p.m. (CDT) on May 1,1997. This information is current as of 12:00 p.m.
on May 2,1997.
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fi GARY SHEAR ;
Contact:
WAYNE SLAWINSKI (630)829-9820 (630)829-9876 ).
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LICENSEE: THEDA CLARK HOSPITAL SITE: THEDA CLARK HOSPITAL EN NUMBER:32254 DOCKET: EVENT DATE: 12-20-96 RX TYPE: EVENT TIME: 00:00 VENDORS: NOTIFY DATE: 05-01-97 EMERGENCY CLASS: N/A REGION: 3 STATE: WI TIME: 16:25 OPS OFFICER: JOHN MacKINNON 10 CFR SECTION: LADM 35.33(a) MED MISADMINISTRATION MEDICAL MISADMINISTRATION ON DECEMBER 20,1996, A PATIENT WAS TO HAVE RECEIVED A DOSE OF 9.4 mci OF l-131. THE DOSE VIAL CONTAINED TWO CAPSULES OF l-131.
THE PATIENT WAS TO HAVE RECEIVED BOTH CAPSULES OF THE l-131, BUT THE TECHNOLOGIST INCORRECTLY THOUGHT THAT EACH 1-131 CAPSULE CONTAINED 9.4 mci AND ONLY ADMINISTERED ONE CAPSULE TO THE PATIENT. THE REMAINING l-131 CAPSULE WAS RETURNED TO ITS LEAD CONTAINER AND PLACED IN STORAGE.
THE MISADMINISTRATION WAS DISCOVERED TODAY WHEN THE REMAINING CAPSULE WAS FOUND IN ITS LEAD CONTAINER. THE PATIENT'S DOCTOR IS SEMI-RETIRED, AND IF THE DOCTOR CANNOT BE CONTACTED BY TOMORROW MORNING, THE RADIATION SAFETY OFFICER WILL INFORM THE PATIENT THAT SHE ONLY RECEIVED 50% OF THE DOSE THAT SHE WAS PRESCRIBED.
NRC REGION 3 (MICHAEL LAFRANZO) WAS NOTIFIED OF THIS EVENT BY THE RADIATION SAFETY OFFICER.
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PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO-IV-95-042 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially J received without verification or evaluation, and is basically all that is known by the Region IV staff on this date.
Facility Licensee Emergency Classification Central Plains Clinic Notification of Unusual Event 1100 East 21st st. Alert Sioux Falls, South Dakota Site Area Emergency Dockets: 03029708 License No: 40-26865-01 General Emergency X Not Applicable
Subject:
MULTIPLE MISADMINISTRATION At approximately 11:00 a.m. (CDT) on September 28,1995, the licensee notified Region IV staff that three misadministration involving dosages of sodium iodide iodine-131 (1-131) had been identified.
The licensee reported that three patients were scheduled to receive 5 millicurie dosages of sodium iodide I-131 on September 18,1995, in preparation for whole body scans to detect metastatic thyroid carcinoma.
The licensee's vendor had shipped the radiopharmaceutical doses as two 2.5 millicurie capsules per patient (each patient's dose was in a separate vial). The technical staff assayed the doses prior to administration and administered each dose on September 18.
On the morning of September 28,1995, the staff was segregating waste material in the hot lab in order to transfer material to the waste storage area. The technologists involved in this activity detected unusual radiation levels on the surface of the three containers in which the sodium iodide I-131 doses were received, causing them to physically examine the containers. Upon examination of the containers, the staff discovered that only one capsule of each container had been administered to the patients and the second capsule remained in each container. Based on review of the vendor's records and confirmatory assays completed at the licensee's facility, the licensee has estimated that approximately 50% of the prescribed dosage was administered (the licensee assayed two capsules together for each dose) to each patient.
The licensee plans to investigate further to determine the root cause of the misadministration. The referring physicians have been notified and the licensee is currently trying to contact the affected patients.
The region plans to conduct a reactive inspection during the week of October 10,1995.
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The state of South Dakota will be informed. Region IV received notification of this occurrence by telephone at 11:00 a.m. (CDT) on September 28,1995. Region IV has informed NMSS.
This information herein has been discussed with the licensee and is current as of 2:15 p.m. on September 28.
Contact:
Linda L. Howell l (817)860-8213
LICENSEE: CENTRAL PLAINS CLINIC SITE: CENTRAL PLAINS CLINIC EN NUMBER:29387 DOCKET: EVENT DATE: 09-18-95 RX TYPE: EVENT TIME: 11:40 VENDORS: NOTIFY DATE: 09-28-95 EMERGENCY CLASS: N/A REGION: 4 STATE: SD TIME: 12:57 l OPS OFFICER: RUDY KARSCH 10 CFR SELTION: LADM 35.33(a) MED MISADMINISTRATION CENTRAL PLAINS CLINIC, SlOUX FALLS, S.D.
THREE OCCURRENCES OF MISADMINISTRATION TO THREE PATIENTS ON THE SAME DAY.
THREE PATIENTS WERE GIVEN DOSES OF IODINE 131 AT 1140,1200, AND 1345 CDT ON 9/18/95. THEY WERE SCHEDULED FOR 5 MILLl-CURIES EACH. IT WAS LATER FOUND (ON 9/28/95) THAT THEY ONLY RECEIVED HALF THE SCHEDULED DOSE, ONE CAPSULE VERSUS TWO CAPSULES. THE PATIENT RAMIFICATIONS ARE MINIMAL AS THE ACCEPTABLE DOSE RANGE IS TWO TO FIVE MILLl-CURIES. THE PATIENTS WILL BE INFORMED.
- , s-PRELIMINARY NOTIFICATION OF EVENT OR UNUSUAL OCCURRENCE PNO-Ill-94-003 This preliminary notification constitutes EARLY notice of events of POSSIBLE safety or public interest significance. The information is as initially received without verification or evaluation, and is basically all that is known by the Region ll1 staff on this date.
Facility Licensee Emergency Classification St. Rita's Medical Center Notification of Unusual Event St. Rita's Medical Center Alert Lima, Ohio Site Area Emergency License No: 34-12100-03 General Emergency X Not Applicable
Subject:
REPORTED IODINE-131 MISADMINISTRATION PN-3-94-003 -- REPORTED IODINE-131 MISADMINISTRATION - On January 20, 1994, the licensee's consultant reported that a patient was administered a sodium iodide iodine-131 capsule containing 9.1 millicuries, rather than the prescribed 15 millicuries. This represents a 39 percent underdose.
On the afternoon of January 19,1994, the licensee received two iodine-131 capsules in a vial from a radiopharmaceutical supplier for a planned hyperthyroid treatment. The vial was checked by the licensee's technologist prior to patient administration and showed a total activity of 15.8 millicuries. The vial's contents were subsequently emptied into a cup and provided to the patient for self-admir.btion. However, one of the two capsules remained in the vial and the technologist erroneously assumed the vial contained only one capsule. The vial was returned to the supplier the following day. On January 20,1994, the supplier informed the licensee that one 6.7 millicurie capsule remained in the vial.
The patient is scheduled to return to the medical center on January 21, 1994, and receive an additional 7 millicurie !odine-131 dose. The licensee does not anticipate any adverse affects to the patient as a result of the misadministration. The patient was informed of the misadministration.
Region 111 (Chicago) will conduct a special investigation to review the circumstances surrounding the misadministration.
The State of Ohio will be notified. The information on this preliminary notification has been reviewed with licensee management.
. The licensee reported this misadministration to the NRC Operations Center at 12:31 p.m. (EST) on January 20,1994. This information is current as l
of 4:00 p.m. (CST) on January 20,1994.
Contact:
B. Holt R. Caniano (708)790-5624 (708)790-5612 i
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LICENSEE: ST. RITA'S MEDICAL CENTER SITF. ST. RITA'S MEDICAL CENTER . EN NUMBER:26649 l- DOCKET: ' EVENT DATE: 01-20-94 l RX TYPE: EVENT TIME: 11:00
- VENDORS: NOTIFY DATE: 01-20-94 EMERGENCY CLASS: N/A REGION: 3 STATE: OH TIME: 12:31 OPS OFFICER: THOMAS ANDREWS 10 CFR SECTION: LADM 35.33(a) MED MISADMINISTRATION ST. RITA'S MEDICAL CENTER 730 WEST MARKET STREET LIMA, OHIO 40801 ON 01/19/94, A 41 YEAR OLD MALE PATIENT WHO WAS TO RECEIVE A PRESCRIBED SODIUM-lODIDE DOSE OF 15 MILLICURIES RECEIVED AN ACTUAL DOSE OF 9.1 MILLICURIES.
THIS IS A RESULT OF A CHANGE IN ROUTINE WHERE THE CENTRAL PHARMACY PREPARED THE DOSE IN TWO CAPSULES INSTEAD OF ONE. WHEN THE DOSE WAS ADMINISTERED, ONLY ONE CAPSULE WAS GIVEN TO THE PATIENT. THE OTHER CAPSULE WAS LODGED IN THE TRANSPORT CONTAINER AND OBSCURED FROM VIEW BY A PACKAGE OF DESICCANT TRANSPORTED WITH THE SOURCE CAPSULES. THE SECOND CAPSULE WAS DISCOVERED BY THE CENTRAL PHARMACY AND REPORTED TO THE THE RADIATION SAFETY OFFICER AT APPROXIMATELY 1100 EST ON 01/20/94.
THE PATIENT HAS BEEN INFORMED. THE PATIENTS PHYSICIAN WILL BE NOTIFIED. THE LICENSEE DOES NOT ANTICIPATE ANY ADVERSE AFFECTS TO THE PATIENT AS A RESULT OF THE EVENT. THE PATIENT HAS BEEN SCHEDULED TO RECEIVE THE REMAINING PORTION OF THE DOSE.
THE LICENSEE PLANS ON INITIATING A PROCEDURE STEP WHERE THE ADMINISTERING TECHNICIAN WILL SURVEY THE TRANSPORT CONTAINER TO ENSURE THE ENTIRE DOSE HAS BEEN GIVEN PRIOR TO RETURNING THE !
CONTAINER TO THE CENTRAL PHARMACY.
THE LICENSEE HAS NOTIFIED REGION lll.
LICENSEE: PAPASTAVROS' ASSOCIATES SITE: PAPASTAVROS' ASSOCIATES EN NUMBER:24994 DOCKET: EVENT DATE: 02-01-93 RX TYPE: EVENT TIME: 14:00 VENDORS: NOTIFY DATE: 02-01-93 EMERGENCY CLASS: N/A REGION: 1 STATE: DE TIME: 17:11 OPS OFFICER: CHAUNCEY GOULD 10 CFR SECTION: LADM 35.33(a) MED MISADMINISTRATION THE LICENSEE REPORTED THAT A PATIENT RECEIVED HALF THE DOSAGE THAT SHOULD HAVE BEEN ADMINISTERED OF IODINE 131 FOR HYPOTHYROIDISM TREATMENT.
THE TREATMENT WAS ADMINISTERED ON 01/14/93 WHEN THE PATIENT WAS GIVEN ONE CAPSULE (14.9 MILLICURIES) BY THE TECHNICIAN INSTEAD OF TWO CAPSULES (30 MILLICURIES) WHICH SHOULD HAVE BEEN ADMINISTERED.
THE SECOND CAPSULE WAS DISCOVERED IN A VIAL TODAY WHILE THEY WERE CLEANING UP THE LAB. THE PATIENT'S PHYSICIAN HAS BEEN NOTIFIED AND THERE SHOULD BE NO ADVERSE AFFECTS TO THE PATIENT.
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