EA-96-099 - South Haven Community Hospital
Mr. Craig J. Marks, President
South Haven Community Hospital
955 South Bailey Avenue
South Haven, Michigan 49090-0489
SUBJECT: NOTICE OF VIOLATION (NRC Investigation Report No. 3-95-025)
Dear Mr. Marks:
This refers to the investigation conducted by the NRC Office of Investigations (OI) to review possible willful violations of NRC requirements involving South Haven Community Hospital (SHCH), South Haven, Michigan. The investigation concerned the improper receipt of NRC licensed material by a nuclear medicine technologist (NMT). The investigation concluded that deliberate violations of NRC requirements occurred. The investigation report synopsis was sent to you on April 16, 1996. Additionally, a transcribed predecisional enforcement conference was held with the NMT on May 6, 1996, at which time the NMT admitted to causing each of the deliberate violations.
Based on the information developed during the investigation, the information in a May 13, 1996, SHCH letter in response to NRC's April 16, 1996, letter, and the information provided by the NMT at the May 6, 1996, conference, the NRC has determined that significant violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice). In summary: NRC-licensed material (technetium-99m) was received at locations other than SHCH; dosages of technetium-99m were not measured prior to being administered to patients; records were inaccurate in that calculated dosage activity was recorded in place of measured activity, and a dosage measurement record for February 14, 1995, was annotated to indicate that a measurement had been made at SHCH when, in fact, the measurement had not been made. NRC acknowledges that each dosage was measured at the nuclear pharmacy prior to dispensing the radiopharmaceutical to SHCH; however, it was your responsibility to verify that the proper material and dosage were being administered.
As the holder of an NRC license, SHCH is responsible for radiation safety at the hospital and is expected to provide effective management and oversight of its licensed programs. Incumbent upon each NRC licensee is the responsibility to protect the public health and safety by assuring that all requirements of the NRC license are met and any potential violations of NRC requirements are identified and expeditiously corrected. To the credit of SHCH, a "Self Identified Regulatory Violation" was issued by SHCH to the NMT on April 7, 1994, documenting the receipt of licensed materials at an unauthorized location. However, this action did not prevent the NMT from again receiving licensed materials at an unauthorized location on February 7, 9, and 14, 1995. The NRC recognizes that SHCH took immediate corrective actions once it became aware of the February 1995 violations. Nevertheless, the recurrence of deliberate violations of NRC requirements indicates that SHCH did not maintain sufficient oversight of licensed activities performed by the NMT which is of significant regulatory concern. The willful violations are categorized in the aggregate in accordance with the "Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III problem.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is normally considered for a Severity Level III problem. Because the violations were willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit was warranted for the identification factor because SHCH identified the violations. Credit was also warranted for the prompt corrective actions taken following the February 1995 incidents, which included: removing the NMT from NRC-licensed activities at SHCH; ceasing to transport radioactive materials to remote sites; and instructing the remaining NMT about adherence to NRC license conditions.
Therefore, to encourage the prompt identification and correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty.
In addition to this enforcement action, a Notice of Violation is being issued to the NMT involved in the deliberate violations. You will receive a copy of this communication under separate cover.
The NRC has concluded that information regarding the reasons for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in the letter from SHCH dated May 13, 1996. 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 respond, you should follow the directions specified in the enclosed Notice.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response (should SHCH choose to respond) will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.
Sincerely, Hubert J. Miller Regional Administrator
Enclosure: Notice of Violation
Chairman, Board of Trustees
South Haven Community Hospital
South Haven Community Hospital Docket No. 030-32015 South Haven, Michigan License No. 21-26266-01 EA 96-099
During an NRC investigation concluded on February 12, 1996, violations of NRC requirements were identified. In accordance with the "Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, the violations are listed below:
A. Condition 10.A of NRC License No. 21-26266-01 requires that licensed material be received, stored and used at 955 South Bailey Avenue, South Haven, Michigan.
Contrary to the above, licensed material was received at locations other than 955 South Bailey Avenue, South Haven, Michigan. Specifically, on April 7, 1994, licensed material, technetium-99m, was received at the Syncor pharmacy, Grand Rapids, Michigan, and on February 7, 9, and 14, 1995, licensed materials, technetium-99m, were received in a parking lot at Bronson Methodist Hospital, Kalamazoo, Michigan. (01013)
B. 10 CFR 35.53(a) requires, in part, that a licensee measure the activity of each radiopharmaceutical dosage that contains more than 10 microcuries of a photon-emitting radionuclide before medical use.
Contrary to the above, on April 7, 1994, and February 7, 9, and 14, 1995, the licensee did not measure radiopharmaceutical dosages containing technetium-99m, a photon-emitting radionuclide, before they were administered to patients for medical use at Three Rivers Area Hospital, Three Rivers, Michigan. Specifically, dosages of 9.27, 4.7, 5.49, and 6.68 millicuries of technetium-99m were not measured prior to administering the dosages to patients on April 7, 1994, February 7, 9, and 14, 1995, respectively. (02013)
C. 10 CFR 30.9(a) requires, in part, that information required by the Commission's regulations to be maintained by the licensee shall be complete and accurate in all material respects.
10 CFR 35.53(a) requires, in part, that a licensee measure the activity of each radiopharmaceutical dosage that contains more than 10 microcuries of a photon-emitting radionuclide before medical use. 10 CFR 35.53(c) requires that a licensee retain a record of measurements required by section 35.53 for three years.
Contrary to the above, on April 7, 1994, and February 7, 9, and 14, 1995, information required by the Commission's regulations to be maintained by the licensee was not complete and accurate in all material respects. Specifically, the licensee's radiopharmaceutical dosage measurement records recorded calculated rather than measured values for millicurie dosages of technetium-99m, a photon-emitting radionuclide. In addition, the record of the February 14, 1995 dosage measurement of technetium-99m was inaccurate in that the record stated that the dosage was specifically measured at South Haven Hospital, South Haven, Michigan when, in fact, no measurement was made. This information was material because NRC relies on records required by 10 CFR 35.53(c) to determine the licensee's compliance with section 35.53(a). (03013)
This is a Severity Level III problem. (Supplements VI and VII).
The NRC has concluded that information regarding the reasons for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in the SHCH letter dated May 13, 1996. 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, D.C. 20555 with a copy to the Regional Administrator, NRC Region III, 801 Warrenville Road, Lisle, Illinois 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation.
Dated at Lisle, Illinois
the 17th day of July 1996