EA-99-153 - North Country Hospital and Health Center, Inc.
July 20, 1999
Sidney Toll, President
North Country Hospital and Health Center, Inc.
Newport, VT 05855
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-17817/99-01)
Dear Mr. Toll:
This refers to the NRC inspection conducted on June 3, 1999, at your facility in Newport, Vermont. The inspection was performed to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements. During the inspection, the NRC learned that there was a misadministration of iodine-131 to a patient at your facility in February 1999. The problem was initially identified to you by the medical institution where the patient received follow up treatment. Despite having this information, your staff apparently did not conclude that a misadministration occurred, and did not inform the NRC, the patient's physician, nor the patient, as required by NRC requirements. In addition, other apparent violations of NRC requirements were identified including violations that contributed to the misadministration. On July 1, 1999, a predecisional enforcement conference was held with you and other members of your staff to discuss the apparent violations, their causes, and your corrective actions. A copy of the enforcement conference report will be sent to you by separate correspondence.
Based on the information developed during the inspection and the information provided during the predecisional enforcement conference, five violations of NRC requirements are being cited. The violations are described in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The first three violations, all of which contributed to the misadministration, involved the failures to: (1) instruct the nuclear medicine technologist who administered the dose of approximately 305 microcuries of iodine-131 to the patient for a thyroid uptake study in accordance with your Quality Management Program; (2) supervise the technologist even though he had not been involved in an iodine-131 administration since 1990; and (3) establish, maintain, and implement the QMP for the facility in that the dose was administered without the preparation of a written directive beforehand. The remaining two violations involve (1) the failure of the Radiation Safety Officer to investigate the misadministration; and (2) the failure to notify the NRC, the patient' physician, or the patient of the misadministration.
During the conference, you noted that the technologist lacked familiarity with the study, not having been involved in such an administration since 1990, and your facility had not performed such an administration since 1993. Nonetheless, you are responsible, through your QMP, for assuring that licensed material is administered as directed by an authorized user. In this case, your QMP failed to provide this assurance, and this failure resulted in a patient receiving a significant amount of unnecessary exposure from this diagnostic procedure. Further, you failed to conclude that a misadministration occurred. As a result, this occurrence was not investigated and neither the NRC nor the patient's physician was informed. Collectively, these violations represent weaknesses in your QMP that resulted in a misadministration. Therefore, these violations are categorized as a Severity Level III problem in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation or problem. Because your facility has not been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions, at the time of the predecisional enforcement conference, were considered prompt and comprehensive. These actions include, but are not limited to: (1) development of a new form and new procedures for the handling and approval for use of iodine-131; (2) revision to the nuclear imaging policy and procedures manual for ease of form and information retrieval; (3) an increase in the time allotted for reviews of the program by a consultant and the Radiation Safety Committee; and (4) plans to obtain an additional radiologist on a part-time basis to assist at the facility.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.
The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence, were already described adequately during the enforcement conference and are adequately addressed on the docket in this letter. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosure, will be placed in the NRC Public Document Room (PDR).
James T. Wiggins for
Docket No. 030-17817
License No. 44-19518-01
Enclosure: Notice of Violation
State of Vermont
NOTICE OF VIOLATION
|North Country Hospital and Health Center, Inc.
|Docket No. 030-17817
License No. 44-19518-01
During an NRC inspection conducted on June 3, 1999, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG -1600, the violations are listed below:
|A.||10 CFR 35.25(a)(1) requires,
in part, that a licensee that permits the use of byproduct material
under the supervision of an authorized user will instruct the supervised
individual in the licensee's written quality management program.
Contrary to the above, as of June
3, 1999, the licensee did not instruct a nuclear medicine technologist
in the licensee's written quality management program. (01013)
|B.||10 CFR 35.25(a)(2) requires, in part,
that a licensee that permits the use of byproduct material by an individual
under the supervision of an authorized user shall require the supervised
individual to follow the instructions of the supervising authorized
The instructions of the supervising authorized user, entitled "Thyroid Uptake" requires, in part, that 8-16 microcuries of iodine-131 be administered for thyroid uptake studies.
Contrary to the above, on February
4, 1999, the technologist, an individual under the supervision of
the licensee's authorized user, administered 305 microcuries of
iodine-131 for a thyroid uptake study, an amount not in accordance
with the instructions of the supervising authorized user. (01023)
|C.||10 CFR 35.32(a)(1) requires, in part,
that the licensee establish and maintain a quality management program
which must include written policies and procedures to meet the objective
that, prior to administration, a written directive is prepared for
any administration of quantities greater than 30 microcuries of iodine-131.
10 CFR 35.2 defines a written directive as an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation and containing certain information including, for greater than 30 microcuries of iodine-131, the dosage.
Contrary to the above, as of June
3, 1999, the licensee's quality management program did not include
a written procedure to meet the objective that a written directive
be prepared prior to administering quantities greater than 30 microcuries
of iodine-131. Specifically, the licensee's quality management program
only addressed the use of greater than 30 microcuries of iodine-131
for therapy and not for thyroid uptake studies. (01033)
|D.||10 CFR 35.21(b)(1) requires, in part,
that the Radiation Safety Officer investigate misadministrations.
10 CFR 35.32(b)(1)(iii) requires, in part, that the licensee shall develop procedures and conduct a review of the quality management program, including evaluation of all misadministrations, to verify compliance with all aspects of the quality management program.
10 CFR 35.2 defines, in part, "misadministration," to mean when both the administered dosage differs from the prescribed dosage by more than 20 percent of the prescribed dosage and the difference between the administered dosage and the prescribed dosage exceeds 30 microcuries.
Contrary to the above, as of June
3, 1999, the licensee's Radiation Safety Officer had not investigated
a misadministration that occurred on February 4, 1999, and had not
evaluated the event to verify compliance with all aspects of the
quality management program. (01043)
|E.||10 CFR 35.33(a) requires, in part,
that, for a misadministration, the licensee shall (1) notify by telephone
the NRC Operations Center not later than the next calendar day after
discovery of the misadministration; (2) submit a written report to
the appropriate NRC Regional Office within 15 days after discovery
of the misadministration; (3) notify the1 referring physician and
also notify the individual receiving the misadministration of the
misadministration no later than 24 hours after its discovery; and
(4) furnish a written report to the individual within 15 days.
Contrary to the above, in February 1999, the licensee became aware of an event that they should have known was a misadministration and as of June 3, 1999, the licensee did not notify and report the event to the NRC, the referring physician, or the individual as required. The misadministration involved the administration of a dosage of 305 microcuries of iodine 131 when the prescribed dose was 8-16 microcuries. (01053)
These violations are categorized in the aggregate as a Severity Level III problem (Supplement VI).
The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violation and prevent recurrence were adequately described during the enforcement conference on July 1, 1999, and are already adequately addressed on the docket in the NRC letter. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).
If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
If you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction.
Dated this 20th day of July 1999