ML20196E631
| ML20196E631 | |
| Person / Time | |
|---|---|
| Issue date: | 04/05/1999 |
| From: | Chamberlain D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | Bailey E CALIFORNIA, STATE OF |
| Shared Package | |
| ML20196E607 | List: |
| References | |
| FOIA-99-233 NUDOCS 9906280349 | |
| Download: ML20196E631 (4) | |
Text
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M6 UNITED STATES y
t NUCLEAR REGULATORY COMMISSION E
REGloN IV 611 RYAN PLAZA DRIVE, SUITE 400
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ARLINGTON, TEXAS 76011-8064 APR - 51999 Ed Bailey, Chief Radiologic Health Branch P.O. Box 924732, MS 178 Sacramento, CA 94234-7320
SUBJECT:
Allegation No. RIV-1998-A-0185
Dear Mr. Bailey:
This letter is in reference to our October 23,1998, letter which acknowledged receipt of the concerns that you provided t.o Richard Bangart, Director, NRC Office of State Programs on October 8,1998. Additionally, my letter advised you that we would initiate actions to review your concerns related to activities conducted by the Department of Veterans Affairs (DVA) at the Contra Costa Medical Center (CCRMC). Finally, my letter advised you that Concerns 1 and 2 would be referred to the DVA Office of Inspector General (OlG) for review, and Concerns 3 -
6 would be reviewed by the NRC.
The NRC has completed its review of Concerns 3 - 6. The enclosure to this letter documents each of your concerns and summarizes how the NRC resolved Concerns 3 - 6. Your concerns are underlined and the resolution is in bold text. In summary, the NRC concluded that the authorization of DVA activities at the CCRMC satellite facility was performed in accordance with NRC licensing requirements and policies. The requirements and controls imposed by the l
license on DVA activities, while operating at the CCRMC satellite facility, are sufficient to
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provide reasonable assurance of public health and safety and to protect employees and patients. Concerns 1 and 2 were referred to the DVA OlG and we will notify you by separate correspondence following receipt of their response.
Should you have any additional questions, please call Russell Wise, NRC Region IV Senior Allegations Coordinator, at (817) 860-8145.
Sincerely,
^
Dwig t D. Chamberlain, Director Division of Nuclear Materials Safety
Enclosure:
As stated CERTIFIED RETURN RECEIPT REQUESTED 9906290349 990624 PDR FOIA HANSEN99-233 PDR W
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RESOLUTION OF CONCERNS RIV-1998-A-0185 1.
The oatients served by the DVA at the CCRMC are not all DVA patients or DVA beneficiaries. More specifically. the patient oooulation served at the facility are primarily indiaent oatients who receive care at a county hosoital.
This concern is under review by the DVA Office of in.spector General.
2.
The DVA has exceeded its federal charter by servina a oatient oooulation which does not consist of veterans.
This concern is under review by the DVA Office of inspector General.
3.
DVA ohvsicians may be conductina nuclear medicine without a medical license issued by the state of California and that by virtue of NRC havina issued the license amendment. the NRC has authorized the oractice by physicians. not licensed by the j
state of California. in a non-federal facility. Additionally. NRC licensina policies do not reauire verification that ohysicians are licensed by the state in which they oractice i
medicine for DVA facilities.
NRC regulations do not require verification that a physician is authorized to practice medicine in the state the byproduct material license is issued. NRC regulations require that authorized users be a physician, dentist, or podiatrist who is board certified by one of the boards listed in 10 CFR 35.910 - 35.960, or is identified on an NRC or Agreement State license that authorizes medical use for byproduct material, or is identified as an authorized user on a permit issued by an 1
NRC or Agreement State specific license of broad scope that authorizes medical use of byproduct material (e.g., U.S. Air force, U.S. Navy or academic medical institutions). Physician, as indicated above, defines a medical doctor or doctor of osteopathy licensed by a state, territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico, and is authorized to prescribe j
I drugs in the practice of medicine. The NRC determined during an inspection conducted on September 29,1998, that, although the medical license status of physician authorized users was not checked, the authorized users practicing at the CCRMC satellite location were identified on the DVA byproduct material license. The NRC determined that licensed activities were directed by authorized j
users at the CCRMC satellite location. It is not necessary that the physical facilities be a federal facility for the NRC to license the activities. The CCRMC satellite location was authorized in Amendment 77 to License 04-02956-02 as an approved use location.
This concern was substantiated. However, no violation of NRC requirements was identified.
- 4.
The DVA may administer radiopharmaceuticals to oatients. release them from the nuclear medicine deoartment. and that the oatient may then return to a patient room at CCRMC. The NRC should not have authorized DVA to perform clinical studies on inoatients at CCRMC.
I 1
l RIV-1998-A-0185 l
The NRC determined that some of the patients administered radiopharmaceuticals at CCRMC were classified as inpatients. The NRC case review identified one case involving an inpatient. The patient was returned to his room at CCRMC after receiving a diagnostic dosage of a radiopharmaceutical and after the nuclear medicine examination was completed. The NRC determined that nothing in the DVA license or NRC regulations prohibits the administration of radiopharmaceuticals to inpatients at a medical facility, provided the condition of the license and NRC regulations are followed.
The NRC determined that patients are routinely administered, on an inpatient basis, diagnostic dosages of radiopharmaceuticals and are allowed to return to their room without further intervention by the nuclear medicine staff. Based on risk assessments and evaluation of potential radiation doses that might be received by members of the public or hospital workers who might care for a patient, the NRC has determined that patients who receive diagnostic dosages of radiopharmaceuticals do not need to be restricted in their activities for the purpose of radiation control. Thus, patients may return to their homes, work place, or hospital room following administration of a diagnostic radiopharmaceutical. Although medicalinstitutions may choose to take certain precautions for inpatients who have received a diagnostic dosage of a
, radiopharmaceutical (i.e., special instructions for collection of laboratory samples or special handling or urinary catheters and co!!ection bags), such precautions are taken as an institutional initiative rather than in response to a regulation.
This concern was substantiated. However, no violation of NRC requirements was identified.
5.
The DVA may not be implementina a radiation safety oroaram sufficient to protect CCRMC emolovees. the public who visit CCRMC. and oatients. Because CCRMC lacks experience in handlina bvoroduct and accelerator oroduced material. and has no commitment to implement a radiation safety proaram for these tvoes of material. the DVA commitment to imolement a radiation safety oroaram is insufficient.
The NRC determined that the DVA has committed to follow and was following an NRC-approved radiation safety program for using byproduct material. At the satellite location in the CCRMC, the DVA used both licensed and non-licensed radiopharmaceuticals. The NRC determined that both byproduct and accelerator i
materials were only handled by personnel from the DVA who had been appropriately trained in radiation safety. The NRC determined that the licensee i
l used the same approved radiation safety practices and procedures identified in its byproduct material license regardless of whether the material was byproduct I
or accelerator produced.
l This concern was not substantiated.
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6.
The DVA. in aeneral. is responsible for the maiority of release of contaminated medical waste in the state of California. You and your staff auestion whether the NRC will i
reauire this clinic to comply with reaulations relatina to the release of contaminated I
material or whether the NRC would respond if contaminated medical wastes were released from the clinic.
The NRC identified that the licensee had only used the radionuclides with half-lives of less than 60 days. The NRC determined that the licensee was following-standard NRC-approved " decay in storage" practices and had not released i
contaminated materials without holding the material for decay. The NRC would expect that if radioactive material was improperly released from the DVA satellite location, the DVA would arrange to have the material returned to the satellite location for proper disposal if the material could be recovered.
j The NRC responds to events in accordance with established policy and guidance.
The level of response provided by the NRC is based on risk of exposure for j
members of the public and the types of quantities of material released if material j
was released from the DVA satellite facility and the type and quantity of material posed a risk to public health and safety, the NRC would respond by conducting a prompt reactive inspection. If the quantity of material posed no risk of exposure and was readily recovered by the DVA, the NRC might choose to perform a prompt review of the incident and conduct a specialinspection based on the i
results of the review. The level of response and timing of an onsite inspection would be determined based on the type and quantity of material released.
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- rero UNITED STATES y
NUCLEAR REGULATORY COMMISSION
,E REGloN IV S
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611 RYAN PLAZA DRIVE, SUITE 400 ARLINGTON, TEXAS 76011-8064 APil - 51999 I
Ed Bailey, Chief Radiologic Health Branch P.O. Box 924732, MS 178 Sacramento, CA 94234-7320
SUBJECT:
Allegation No. RIV-1998-A-0185
Dear Mr. Bailey:
This letter is in reference to our October 23,1998, letter which acknowledged receipt of the concems that you provided to Richard Bangart, Director, NRC Office of State Programs on October 8,1998. Additionally, my letter advised you that we would initiate actions to review your concerns related to activities conducted by the Department of Veterans Affairs (DVA) at the Contra Costa Medical Center (CCRMC). Finally, my letter advised you that Concerns 1 and 2 would be referred to the DVA Office of Inspector General (OlG) for review, and Concerns 3 -
6 would be reviewed by the NRC.
The NRC has completed its review of Concems 3 - 6. The enclosure to this letter documents each of your concerns and summarizes how the NRC resolved Concerns 3 - 6. Your concerns are underlined and the resolution is in bold text. In summary, the NRC concluded that the authorization of DVA activities at the CCRMC satellite facility was performed in accordance with NRC licensing requirements and policies. The requirements and controls imposed by the license on DVA activities, while operating at the CCRMC satellite facility, are sufficient t'o provide reasonable assurance of public health and safety and to protect employees and patients. Concerns 1 and 2 were referred to the DVA OlG and we will notify you by separate correspondence following receipt of their response.
Should you have any additional questions, please call Russell Wise, NRC Region IV Senior Allegations Coordinator, at (817) 860-8145.
Sincerely,
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Dwig t D Chamberlain, Director Division of Nuclear Materials Safety
Enclosure:
As stated '
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STATE OF CAUFORNWTH AND HUMAN SERVICES AGENCY GRAY DAVIS. Govemor "DEPARTidENT OF HEALTH SERVICES f. RADIOLOGIC HEALTH BRANCH
. P.O. BOX M2732. Ms-178 SACAAMENTO.CA M234-7320 pies 4smat April 29,1999 Mr. Paul Lohaus Director Office ofState Programs l
Nuclear Regulatory Commission
. Washington, D.C. 20555 Lj,,,g
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Dear Mr. Lohaus:
I hereby request, under the federal Freedom ofInformation Act, a copy of all correspondence / documents regarding the use of radioactive materials by the Veterans Administration (VA) Medical Center, Martinez, Califomia, at the Contra Costa Regional Medical Center (CCRMC). Specifically requested is the response from the VA to NRC's letter to VA that resulted from the allegation filed by Califomia regarding the illegal use of radioactive
. materials by the VA at CCRMC.
This FOIA request is being made because the Regional Counsel in Region IV has refused to give a copy of the VA's response to the attomey for the Califomia Radiologic Health Branch upon his verbal request for the document. The Regional counsel for Region IV instructed our attorney to file a FOIA request. We will be discussing this lack of cooperation with you at future meetings, etc.
Sincerely,-
l 3
gar D.
iley, C. H.., hief Radiologi Health Branch cc:
Linda McLean Regional State Agreements Officer.
h Nuclear Regulatory Commission L
611 Ryan Plaza Drive, Suite 400 Arlington, TX '76011 Director Division of Freedom ofInformation and Publication Services Office of Administration Nuclear Regulatory Commission
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. Washington, D.C. 20555 ~
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