ML20214M135
| ML20214M135 | |
| Person / Time | |
|---|---|
| Site: | 07001389 |
| Issue date: | 05/19/1987 |
| From: | Daniher F ST. FRANCIS HOSP., EVANSTON, IL |
| To: | Axelson W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| References | |
| NUDOCS 8706010185 | |
| Download: ML20214M135 (15) | |
Text
a. COPY S o ril bc f1Ct5 % !al EFK3yOvEfUSa6nstrl!fros602CQ 3R/472-zicco May 19,1987 W.L. Axelson, Chief
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Nuclear Safety and Safeguards Branch U.S.N.R.C. Region III 799 Roosevelt Road Glen Ellyn. Illinois 60137 RE:
Dear Mr. Axelson:
This letter is in response to your letter dated May 5, 1987 concerning the special safety inspection conducted by Ms. C.C. Casey of Region III from February 24 through April 3, 1987, and region III Report No. 070-01389/87001 (DRSS).
We have responded to the six violations listed in your May 5, 1987 letter in three parts.
Immediately following this letter is a brief summary of Saint Francis Hospital's plan to avoid further violations with respect to this project.
Following the Summary is an item by item response to your letter.
Last is a Management Control Policy that defines administrative responsibility and requirements for management control of material licen-ses.
Please be assured that the management staff of Saint Francis Hospital shares your concern regarding the control of this project.
We would welcome any comments or suggestions you may have on our plan to improve our effect-iveness in this area.
Thank you for your time and cooperation in this matter.
If you have any questions, please do not hesitate to contact either Eric Zickgraf or me.
Sincerely, hCtmCLO m
Frances A. Daniher Vice President-0perations 8706010185 070519 REG 3 LIC70 SNM-1426 PDR 1
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E. Zickgraf J.C. Gizzi EIAY p s 19R1
PROJECT 238
SUMMARY
OF CORRECTIVE-ACTION TO AVOID FURTHER VIOLATIONS The Radiation Safety Officer (RS0) and the Pacemaker Clinic of Saint Francis Hospital are now taking an active part in the follow-up of the project 238 pacemaker patients. The staff of the Radiation Safety Office and the Pacemaker Clinic have copies of the Medtronic protocol and are familiar with their contents. The RS0 (or his/her designee) will contact the Pacemaker Clinic Staff at least semi-annually to insure that the patient currently in the study is being followed as per the conditions of our license and protocol.
Copies of the follow-up examinations (required at six month intervals) will be kept in the Pacemaker Clinic (a division of the Galvin Heart Center) and in the Radiation Safety Office. The surgical records of the implantations have been and will continue to be kept in the Medical Records Department.
The Medical Records Department does not maintain outpatient records on any patients.
The RSO will report on the status of the hospital's compliance with SNM-1426 pacemaker license at least semi-annually to the Radiation Safety Committee concerning routine matters, and immediately to the RSC chairman of any changes in the status of the pacemaker project, the patient, or hospital personnel involved in maintaining compliance with the license.
The RS0 will report on the status of the hospital's compliance with the SNM-1426 pacemaker license on an annual basis to the Vice-President of Operations (Clinical Services), the Executive Vice-President, and the President.
Administration will be informed immediately by the RSO or the chairman of the RSC immediately of any changes in the status of the pacemaker project, the patient, or hospital personnel involved in maintaining compliance with the license.
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o 6-4 PROJECT 238 Item-by-Item Response to Ma3 5, 1987 Letter Item 1.
4 A) Corrective action taken and the results achieved:
A copy of our current emergency telephone contact program is enclosed (seeattachment1). A draft copy of the document was circulated to the Director of Telecommunications, the administrative director of the Galvin Heart Center, the director of the Pacemaker Clinic and the director of the Cardio-Thoracic Surgery department on March 1,1987. The draft copy was approved with minor revisions and the final approved document was implemented as of March 1,1987.
B) Corrective action taken to avoid further violations:
The Radiation Safety Officer (or his/her designee) will contact the Telecommunications department on a semi-annual basis to check that the Project 238 telephone protocol is currently in effect.
C) The date when full compliance will be achieved:
Full compliance was achieved as of March 1,1987.
f*-
Telephone Contact Program PROJECT 238 March 1,1987 ANY CALL CONCERNING " PROJECT 238" INVOLVES A PATIENT WITH A NUCLEAR POWERED PACEMAKER AND REQUIRES IMMEDIATE ACTION TO INSURE THAT THERE IS NO DANGER
- 0F RADIATION EXPOSURE AND RECOVERY OF THE NUCLEAR PACEMAKER.
Instructions to Operator:
- 1) Accept any collect call with reference to Project 238
- 2) Transfer the call to:
A: Administrative Director of the Galvin Heart Center: Nancy O' Conner office: x6150 home: -470-0273 B: Cardiology Fellow on Call if Nancy O' Conner cannot be reached.
Information Needed from Caller:
- 1) Caller's Name and where he/whe may be reached.
- 2) Patient's Name and where he/she may be reached.
- 3) Attending physicians and where he/she may be reached.
Information Needed fromthe Patient's ID Card:
- 1) Patient's Social Security Number
- 2) Date of Implant
- 3) Pacemaker Serial Number Notify Immediately:
T. Murphy, M.D. Project 238 Director A. Estrada, M.D. Director of the Pacemaker Clinic E. Zickgraf, M.S., Radiation Safety Officer i
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Item 2.
A) Corrective action taken and the results achieved:
Six patients at Saint Francis Hospital had Medtronic Model 9000 isotopic powered pacemkers implanted as part of this project. Five of the patients have had their pacemakers explanted and require no further followup. The location of the sixth patient was found on March 4,1987 at 6 PM. The director of the Pacemaker Clinic, Dr. Alfonso Estrada, was given the name and address of the patient and the patient's current cardiologist in addition to followup forms and a copy of the Medtronic Project 238 protocol on March 5.
The pacemaker clinic contacted the patient, and the patient was seen by Dr. Estrada on March 13,1987.
The followup form was completed at that time, and copies were sent to Medtronic, the R50, and Region III USNRC. The patient agreed at that time to report for semi-annual checkups as per the protocol. Saint Francis Hospital will underwrite the expense of these followup visits to encourage the patient's cooperation (see attachment 2). Copies of all future examinations will be sent to Medtronic and to the RSO. The Pacemaker Clinic now has the responsibility to follow our project 238 patient.
B) Corrective action taken to avoid further violations:
The RSO (or his/her designee) will contact the Pacemaker Clinic at six month intervals to verify the status of the patient in the project 233 study. The director of the Pacemaker clinic has agreed to infonn the RSO of all changes in the status of the patient as soon as they become known.
In addition, a cardiologist is being added to the Radiation Safety Committee to enhance the cocTnunication between the Cardiology department and Radiation Safety.
C) The date when full compliance will be achieved:
We have been in full compliance with this license condition as of March 13,1987.
O santfrcmshosptd 355ndgeeenueaenstenIms6o2o2 3Y2/492-4000 May 13, 1987 Ms. Kathryn Abangan 106 Bernard Drive Buffalo Grove Illinois 60089
Dear Ms. Abangan:
I am writing on behalf of Saint Francis Hospital Pacemaker Project.
It has come to my attention that you have a pacemaker that was implanted at Saint Francis Hospital that requires follow-up two times per year.
I understand that you visited Dr. Estrada of our staff in March of this year, at which time he checked l
the pacemaker in accordance with the Nuclear Regulatory Comission requirements under which we must monitor your pacemaker until removal.
I understand from talking with Colleen Casey at the Nuclear Regulatory Commission that you had indicated that you had been billed for your March follow-up visit and that you felt that if follow-up visits were a requirement, and not voluntary on your behalf, that you did not feel it was appropriate to have to pay for these visits.
I have reviewed this policy with Dr. Estrada and we have agreed that you will not be billed for future follow-up visits.
It is of utmost importance to us that we gain your cooperation in assuring appropriate follow-up on your pacemaker.
To assure a smooth process with our billing department, I would recomend you bring a copy of this letter with you for your next follow-up visit.
I will, of course, also pass this information directly to Dr. Estrada, the Pacemaker Clinic, and the Billing Office.
I appreciate your cooperation in this project.
Please let me know if you have any other questions or comments about this process.
Sincerely, AcuvfJA 0 hv Frances A. Daniher Vice President - Clinical Services FAD /cn bbc:
Eric Zickgraf Dr. Estrada Colleen Casey
Item 3.
A) Corrective action taken and the results achieved.
The Radiation Safety Office and the Pacemaker Clinic have been designated the coordinators of the follow-up examinations and procedures as listed in the Medtronic protocol for all our project 238 pacemaker patients.
The SFH Pacemaker Clinic is currently following our single current project 238 nuclear powered pacemaker patient. The director of the pacemaker clinic has a copy of the project 238 protocol and is familiar with it. The director of the-pacemaker clinic will notify the RSO inanediately upon loss of contact with the patient, hospitalization of the patient for the removal of the pacemaker, or upon the death of the patient. The RSO and the director of the Pacemaker Clinic will make the necessary arrangements to return the pacemaker to Medtronic upon explant.
The current pacemaker patient in project 238 has a new current ID card and will receive a new current ID bracelet in May. The current ID bracelet has Dr. Shah-Mirany's telephone number on it, and Dr. Shah-Mirany's office will forward any infonnation to us sent to him by the patient.
B) Corrective action taken to avoid further violations.
The RSO (or his/her designee) will inquire about the status of the project 238 pacemaker patient on at least a semi-annual basis. The Pacemaker Clinic is aware of the protocol requirements and will inform the RSO of any changes in the status of the protocol patient.
C) The date when full compliance will be achieved.
We were in compliance with this license condition as of March 5,1987.
Item 4.
A) Corrective action taken and the results achieved:
Followup records of the current patient in the protocol are being kept I
in the Pacemaker Clinic with copies in the Radiation Safety Office.
The surgical reports of all the pacemaker implants are kept in Medical l
Records. The followup records previous to 1987 of all the patients who no longer have their nuclear powered pacemakers are being kept in the Radiation Safety Office.
The Medical Records Department of Saint Francis Hospital does not maintain follow-up records and outpatient records on patients. Outpatient records are kept in doctors' offices and in the departments that provide the services. Consistent with this hospital procedure, follow-up visit records for the one remaining patient in the pacemaker project will be kept by the Pacemaker Clinic and the RSO. Records for the March, 1987 follow-up visit by the patient are on file in these two locations.
l B) Corrective action taken to avoid further violations:
Follow-up records will be kept in two locations: The Radiation Safety Office under the control of the RSO, and the Pacemaker Clinic under the control of the director of the clinic.
I C) The date when full compliance will be achieved:
Compliance with the revised procedure as described in response to items 4A and 48 has been achieved as of March 19,1987. Saint Francis Hospital request acceptance from the USNRC of this change in procedure,
l Item 5.
j A) Corrective action taken and the results achieved:
We are currently following our single project 238 patient through the hospital's pacemaker clinic. The personnel staffing the pacemaker clinic have been instructed regarding the project 238 protocol and will report any loss of contact with the patient insnediately to the Radiation Safety Officer. The RSO will then notify the USNRC within 10 days from the time the loss of contact with the patient was known by the hospital.
B) Corrective action taken to avoid further violations:
The RSO will be in contact with the Pacemaker Clinic staff at least semi-annually to insure on-going contact with the patient and that the personnel are aware of the provisions of the project 238 protocol.
C) The date when full compliance will be ahcieved.
We were in compliance with this license condition as of March 5,1987.
Item 6.
A) Corrective action taken and the results achieved:
We are currently following our single project 238 patient through the
. hospital's Pacemaker Clinic. The personnel staffing the clinic are familiar with the project 238 protocol and are under instructions to forward any knowledge of the deapth of the pacemaker patient, or any adverse reaction and/or malfunction involving the pacemaker system, including the leads, imediately to the RSO. The RSO will notify the USilRC within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the hospital's knowledge of the above occurence. A written report will be sent by the hospital to the USilRC within 30 days detailing the adverse reaction /and or malfunctior..
Our current pacemaker patient has been supplied with a new ID card from Medtronic and will be receiving a new ID bracelet (furnished by the hospital) in May (it is currently on order for delivery in mid May).
B) Corrective action taken to avoid further violations:
The RSO will be in contact with the pacemaker clinic personnel at least semi-annually to insure on-going contact with the patient and that the personnel are aware of the provisions of the project 238 pro tocol.
C) The date when full compliance will be achieved.
I We were in compliance with this condition of our license as of March 5,1987.
Management Control Policy: Material Licenses (USNRC and IDNS)
The personnel primarily involved in insuring compliance with licensed activities are 1) Vice President of Operations (Clinical Services),
- 2) Radiation Safety Officer, 3) Authorized Users, and 4) the chairman of the Radiation Safety Committee.
The Vice President of Operations (Clinical Services) is the administrative representative on the Radiation Safety Comittee and reports to the Executive Vice President.
The Radiation Safety Officer has the duty of ensuring that all conditions of all the radioactive material licenses are being met or surpassed. The RS0's reporting relationship is to the Radiation Safety Coninittee and to the Vice President of Operations (Clinical Services)
(See attachment 3--Organizational chart). The RS0 will report at least annually on the status of the hospital's compliance with all license, State, and Federal requirements.
The Radiation Safety Committee chairman has the duty of ensuring that the Radiation Safety Program at the hospital adequately addresses all aspects of radiation safety. The RS0 will report at least semi-annually to the RS0 on the status of compliance with all license, State and Federal requirements.
The Vice President of Operatior. (Clinical Services), the Radiation Safety Officer, the Chairman of the Radiation Safety Committee, and all Authorized Users have the duty of informing their successor of all license and radiation safety requirements applicable to the position.
There will be a group meeting as soon as possible after a personnel change to insure that the person filling the vacancy has all the necessary information to perform his/her duties adequately and to meet all the conditions of State and Federal licenses, rules, and regulations.
Management ~ Control Policy:
Plutonium Pacemaker Project The personnel primarily involved in insuring compliance with the SNM-1426 license are:
- 1) Vice President of Operations (Clinical Services),
- 2) Radiation Safety Officer, 3) Project 238 Director, 4) Pacemaker Clinic Director, and 5) the chairman of the Radiation Safety Committee.
-The Vice President of Operations (Clinical Services) is the administrative representative on the Radiation Safety Committee and reports to the Executive Vice President.
The Radiation Safety Officer has the duty of ensuring that all conditions of all the radioactive material licenses are being met or surpassed. The RS0's reporting relationship is to the Radiation Safety Committee and to the Vice President of Operations (Clinical Services)
(See attachment 3--Organizational chart). The RSO will report at least annually on the status of the hospital's compliance with the SNM-1426 I
pacemaker license.
The Radiation Safety Committee chairman has the duty of ensuring that the Radiation Safety Program at the hospital adequately addresses all aspects of radiation safety. The RSO will report at least semi-annually to the RSC
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on the status of compliance with the SNM-1426 license.
l The current Project 238 director supervises patient selection, the I
surgical implantation of the nuclear powered pacemakers, and that follow-up procedures are instituted by the Pacemaker Clinic.
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O The director of the Pacemaker Clinic has the duty to supervise the continued follow-up of all the pacemaker patients in this project, to supply copies of the follow-up reports to Medtronic and the Radiation Safety Office, and to report any changes in the status of the patient or the pacemaker to the RSO immediately upon learning of the change. The RS0 will contact the Project 238 Director semi-annually to verify the status of the one remaining patient in the study.
The Vice President of Operations (Clinical Services), the Radiation Safety Officer, the Chairman of the Radiation Safety Committee, the Director of Project 238, and the Director of the Pacemaker Clinic all have the duty of informing their successor of all license and radiation safety requirements applicable to the position.
.nis gro;p will meet as soon as possible after a personnel change to insure that the person filling the vacancy has all the necessary information to perform his duties adequately and to meet all the conditions of the license.
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