ML20151L620
| ML20151L620 | |
| Person / Time | |
|---|---|
| Site: | 07001718 |
| Issue date: | 07/19/1988 |
| From: | Glenn J, Lester Tripp NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | |
| Shared Package | |
| ML20151L603 | List: |
| References | |
| 70-1718-87-01, 70-1718-87-1, NUDOCS 8808040096 | |
| Download: ML20151L620 (8) | |
Text
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U.S. NUCLEAR REGULATORY COMMISSION REGION I Report No.
070-01718/87-001 Docket No. 070-01718 License No. SNM-1531 Priority 7
Category K
Licensee: Shadyside Hospital 5230 Centre Avenue PTttsburgh, Pennsylvania 15232 Facility Name: Shadyside Hospital Inspection At:
Pittsburgh, Pennsylvania Inspection Conducted: April 15,1987 Inspectors:
dik m%d k/9 LesterM.Tripp,Healtyf;hysicist date s1gned 7 f /f [
Approved by
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bhn E. Glenn, Chief date signed uclear Materials Safety Section B Inspection Summary: Special, announced inspection on April 15, 1987 (Inspection No. 070-01718/87-001).
Areas Inspected:
Special announced inspection to review circumstances associated EtE the failure to remove and properly dispose of a plutonium-238 powered pacemaker from a deceased patient.
l Results: Three apparent violations were identified: failure to notify the NRC, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, of the death of a nuclear pacemaker patient; failure to recover a nuclear pacemaker from an expired patient and properly dispose of the pacemaker; and failure to perform weekly telephone monitoring of l
a patient implanted with a nuclear pacemaker.
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DETAILS 1.
Persons Contacted
- David Martin, Hospital Administrator
- Ralph M. Caputo, Chairman, Radiation Safety Committee
- Ronald Scala, Consultant Physicist
- Peggy Gavenda, Head Nurse, Heart Station David Rigo, Funeral Director, McCabe Brothers Funeral Home Dave Allias, Senior Deputy Coroner, Allegheny County Coroner's Office Jerry McCabe, McCabe Brothers Funeral Home Linda Whigham, former Cardiovascular Technologist at Shadyside Hospital Dr. William B. Tuttle, Cardiologist
- indicates those present at exit interview
===2.
Background===
On October 16, 1986, Region I received telephone notification from Ronald Scala, Consultant Physicist to Shadyside Hospital, that a plutonium-238 powered pacemaker apparently had been disposed in the nomal trash. Mr. Scala was informed that a written report should be filed with Region I.
The events surrounding the disposal of the pacemaker were summarized in the licensee's letter to Region I dated November 18, 1986 signed by Ralph Caputo Chairman, Shadyside Hospital Radiation Safety Committee. This letter states:
The plutonium powered pacemaker was manufactured by Arco Medical Products and was implanted at Shadyside Hospital on March 4, 1976.
The patient expired on December 18, 1985 and the hospital was made aware of his death on December 20, 1985 when they attempted to set up a routine transtelephonic pacer analysis.
1/_
An employee of the hospital called the Coroner's Office requesting that the pacemaker be removed. The employee also called Arco Medical Products, Philadelphia, Pennsylvania the manufceturer of the pacemaker, and informed them that the pacemaker was at McCabe Brothers Funeral Home, Pittsburgh, Pennsylvania and confirmed with McCabe Brothers Funeral Home that they would return the pacemaker when they received a package from ARCO.
In January 1986, David Rigo, Funeral Director of McCabe Brothers Funeral Home called a physician associated with the hospital, and requested that he accept the pacemaker. His request was refused.
1/_ The "transtelephone pacer analysis" is described in Paragraph 5.c.
3 The plutonium pacemaker was thrawn in the normal trash on August 31, 1907 by the Funeral Home. The trash from the Funeral Home is taken to a local landfill.
3.
Allegheny County Coroner's Office The inspector visited Dave A111as, Senior Deputy Coroner of the Allegheny County Coroner's Office, on April 14, 1987.
Review of the coroner's report revealed that the deceased had gone to a local restaurant for breakfast shortly after 6:00 a.m. on December 21, 1985. He expired about 6:15 a.m.
and was pronounced dead at 6:30 a.m. at the restaurant. A supplemental coroner's (autopsy) report stated that on December 21, 1985 at 10:20 a.m.
Shadyside Hospital was contacted and asked to provide information on the deceased, but the Hospital provided none.
The report does not state what infomation was requested or who made or answered the call, nor does it mention a nuclear pacemaker.
The supplemental autopsy report states that the autopsy consisted of an external examination of the deceased and notes the presence of a permanent subcutaneous pacemaker below the lateral portion of the right clavicle.
The cause of death was deemed to be atherosclerotic cardiovascular disease and carotid atherosclerosis. The Senior Deputy Coroner stated that the pacemaker was not removed from the deceased. The coroner's report contained no mention of the pacemaker being nuclear powered.
4.
Shadyside Hospital On April 15, 1987 the inspector interviewed the Chaiman of the Shadyside Hospital Radiation Safety Committee, the Consultant Physicist and the Head i
Nurse of the Heart Station, and reviewed records associated with the pacemaker program. The infomation wtained during these interviews is l
sumarized in Paragraph 5.
Dr. William B. Tuttle, Cardiologist, was responsible for follow-up of nuclear pacemaker patients.
In April,1987 Ralph Caputo was responsible for Radiation Safety at Shadyside Hospital.
5.
Interviews a.
Chairman, Radiation Safety Comittee (RSC) l The Chaiman of the Radiation Scfety Comittee stated that there had been several personnel changes involving persons who were involved with the nuclear pacemaker program at the time of the incident under review. Two Assistant Administrators and the Cardiovascular te.chnolo-i gist who were involved in the program are no longer with the Hospital, l
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4 b.
Consultant Physicist The Consultant Physicist stated that he was not involved with the pacemaker program in December of 1985. He stated that the Chainnan of the RSC, the Head Nurse of the Heart Station, and himself pieced together the sequence of events surrounding the disposal of the nuclear pacemaker from various notes in the patient's file. They approximated the date of death, resulting in an error in the report to the NRC.
(The report places the date of death as December 18, 1985; the coroner's report states December 21, 1985 as the date of
-death). The physicist determined that the pacemaker had been disposed to the nonnal trash through his discussions with personnel at McCabe Brothers Funeral Home, c.
Head Nurse, Heart Station The Head Nurse of the Heart Station stated that the procedure for following nuclear pacemaker patients is to contact the patient once per month.
In addition she stated that every six months the hospital sets up a transtelephonic pacer analysis. The transtelephonic pacer analysis is a procedure through which the hospital receives information about the functioning of the pacemaker and an electrocardiogram of the patient through impulses transmitted via the telephone.
The Head Nurse further stated that an attempt was made about December 20, 1985 to set up the routine semi-annual transtelephonic pacer analysis with the pacemaker patient. She stated it was at this time that the hospital became aware of the death of the patient.
She was unsure exactly who at the telephone contact number infonned the hospital of the patient's death, because she was not present and notes are incomplete.
Further she stated that if more information were needed, to contact the Cardiovascular Technologist who was present at the time, d.
Cardiovascular Technologist (C.V.T)
The C.V.T., a former employee of the licensee, was contacted on April 21,1987.
She stated that the mortuary had contacted the hospital at the time the deceased was brought in and asked her what sho.1d be done with the pacemaker.
She stated that she told the mortuary employee that the manufacturer of the cardiac pacemaker, Arco Medical Products, would be contacted and would forward special packaging and instructions to the mortuary for transport of the cardiac pacemaker to Arco. According to the fonner C.V.T., Arco was contacted at that time and reque5ted to send, to the mortuary, packaging and instructions for transport of the cardiac pacemaker back to Arco. She stated that, to the best of her knowledge, no follow-up had been done to assure that the package was sent from Arco to the mortuary.
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e.
Cardiologist The Cardiologist who was assigned to follow the progress of the patient was interviewed by telephone on April 21, 1987. He stated that he did not recall being contacted by the Allegheny County Coroner's Office or the Funeral Home concerning the nuclear pacemaker patient. However he did recall being contacted by Arco Medical Products many months after the death of the patient, but he did not recall the exact date of the contact.
f.
Funeral Home Director McCabe Brothers Funeral Home is located at 5300 Penn Avenue, Pittsburgh, Pennsylvania. The inspector interviewed Jerry McCabe of McCabe Brothers Funeral Home on April 14, 1987. He was unable to provide any informa-tion relative to the matter and deferred to David Rigo, the Director.
Mr. Rigo was interviewed by telephone on April 20, 1987. He stated that he had personally handled the disposition of the deceased in December of 1985. He also stated that they received the individual's remains, his personal effects and (in a plastic bag) the explanted pacemaker from the coroner's office on or about December 21, 1985.
He recalls contacting Shadyside Hospital on or about December 21, 1985 and was told that the hospital would contact Arco and tell Arco to send special packaging so that the funeral home could return the pacemaker to Arco. The pacemaker was placed in a cabinet in the embalming room of the mortuary until late August or early September 1986, when Mr. Rigo personally placed it in the normal trash. Further, he stated that he never had any contact with Arco nor did he ever receive a package from Arco or the hospital.
7.
Licensee Action on Previous Inspection Finding Inspection No.85-001 on February 19, 1985:
(0 pen) Failure to notify NRC of loss of contact with a nuclear pacemaker patient.
In response to the Notice of Violation enclosed in NRC letter dated March 14, 1985, the licensee stated that they had made arrangements to continuously monitor the nuclear pacemaker patient with whom they had lost contact. However, the licensee did not describe actions taken to assure that the NRC would be notified within ten days of loss of contact with a patient in the future.
8.
Program Requirements The licensee is required to notify the NRC, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, of the death of any patient in which a nuclear pacemaker has been implanted.
However, the death of a nuclear pacemaker patient which occurred on December 21, 1985 was not reported to the Comission until October 16, 1986.
6 The failure to report to the NRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after notification the occurrence of the death of patient implanted with a nuclear pacemaker is an apparent violation of Condition 13 of License No. SNM-1531.
The licensee is further responsible for recovery of the nuclear pacemaker and return to the manufacturer for authorized disposal. However, the nuclear pacemaker was apparently removed by the Allegheny County Coroner's office.
Subsequently, the explanted nuclear pacemaker was forwarded to a mortuary with the remains of the deceased. The pacemaker was then placed in a cabinet in the embalming room and in late August or early September, 1986, the mortuary disposed of the pacemaker to the nonnal trash.
The failure to dispose of licensed material in an authorized manner is an apparent violation of 10 CFR 20.301 and Condition 15 of License No. SNM-1531.
The licensee is required by Condition 16 of its license to monitor the functioning of the pacemaker weekly by telephone after the nineteenth week of implantation. The inspector determined that the periods between monitoring, after the nineteenth week of implantation, was greater than one week.
At the time of the inspection, patients were being monitored at six month intervals.
The failure to monitor nuclear pacemakers by telephone at least once a week after the nineteenth week of implantation is an apparent violation of Condition 16 of License No. SNM-1531.
9.
E :it Interview The inspector met with the licensee representatives identified in paragraph I at the close of the inspection. The inspector sunwarized the purpose and scope of ti;e inspection and the findings. The licensee representatives expressed a desire to bring the program into full compliance.
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SYNOPSIS This investigation was initiated upon the written request,"dated July 17, 19P.7, from the Regional Administrator, Region I.
The Office of Investigations (01) was asked to determine the circumstances which led to an apparent material false statement made to the NRC by Shadyside Hospital (SSH), Pittsburgh, Pennsylvania, in a 1985 license renewal aoplication.
On October 4, 1985, as a part of the review of the application for renewal of SSH's License No. SNM-1531, Region I made a written request to SSH for information pertaining to the status of their nuclear pacemaker patients.
SSH's license requires that they' continually maintain patient follow-up during the life of the patient and follow procedures for recovery of and authorized disposal of the pacemaker upon death of the patient.
On January 2, 1986, the NRC received an undated letter, signed by the Assistant Administrator of SSH.
The letter stated that one of the two implanted patients continued to have a nuclear pacemaker, however, the other patient had recently died. The letter indicated that the pacemaker of the deceased patient had been explanted and returned to the manufacturer as required. Based on these statements, the NRC took no further action and the license was renewed for a five-year period.
On October 16, 1986, Region I received telephonic notification from SSH that the pacemaker from the deceased patient had not been returned to the manufacturer, but instead had been disposed of in the normal trash.
In a letter dated November 18, 1986, SSH stated that the explanted pacemaker had remained at the funeral home awaiting the arrival from the manufacturer of the prop; container required to return the pacemaker. However, after several months had clapsed and the funeral home still had not received the container, they (fur.eral home) disposed of the pacemaker in the normal trash. The letter also sumarized the sequence of events from the time SSH learned of the patient's death to the time of the disposal of the pacemaker.
On April 14 and 15, 1987, an NRC Inspector commenced an inspection at SSH to determine the circumstances surrounding the handling of the pacemaker.
However, due to a number of inconsistent points in the November 18, 1986, letter and information being given to the Inspector, the inspection was suspenced.
When questioned, personnel from the Coroner's Office stated that the deceased body was transported to their office and only a non-invasive (external) examination of the body was performed prior to releasing it to the funeral home.
Personnel from the funeral home stated that when the body arrived at their establishment from the Coroner's Office, it was accompanied by a plastic bag containing the pacemaker. They further stated that SSH asked them to retain the pacemaker until suitable packaging was received by them (funeral home) for its return to the manufacturer. After several months elapsed and the container did not arrive, they threw the pacemaker in the trash.
SSH personnel responsible for the letter dated November 18, 1986, stated that they were either not involved originally or were not on duty at the time of the Case No. 1-87-012 1
ENCLOSURE 2
1 patient's death. They indicated that the letter was composed primarily from notes made by the former Non-invasive Cardiovascular Technician (CVT), who is no longer employed by SSH. They further indicated that SSH's Administrative Policy and Procedure memorandum, dated April 25, 1975, pertaining to the death l
of a nuclear pacemaker recipient, was not followed. This memorandum sets forth the procedures to follow upon notification of emergency for, or death 1
of, a nuclear pacemaker recipient.
The former CVT stated that she had called the home of the subject patient cr.
December 20, 1985, and after receiving no answer, assumed that the patient w8s not at home. She added that on her next scheduled workday, she learned that the patient was deceased. She said that she called the funeral home and was informed that the pacemaker was there and they were seeking instructions for its disposition. After contacting the NRC and the pacemaker manufacturer, she again called the funeral home and informed them that the manufacturer would send them (funeral home) a container so that the pacemaker could be returned to the manufacturer.
The staff surgeon who witnessed the implanting of the pacemaker stated that he vaguely recalls the implantation and he never saw the petient after the implantation.
The referring cardiologist stated that he normally saw the patient every six months after he was implanted with the pacemaker.
He added that he was aware that the patient was deceased, but was not aware that there was a problem with the disposition of the explanted pacemaker until he received a call from the manufacturer several months after the patient's death.
Due to conflicting testimony, this investigation did not disclose who explanted the pacemaker, or its final disposition.
This investigation revealed that SSH made a false statement to the NRC, in an undated letter received by the NRC on Jaruary 2, 1986, by failing to ascertain the disposition of a nuclear pacemaker in careiss disregard of the licensing conditions. The investigation established that SSH had made appropriate arragements to have the pacemaker returned to the manufacturer, but failed to determine whether this had been accomplished when the letter was submitted.
The former SSH official who signed and presumably prepared the letter is no longer employed by SSH and could not be located for interview purposes. No other SSH personnel acknowledged being aware of or reading the letter at the time it was sent to the NRC.
Case No. 1-87-012 2