[Federal Register Volume 59, Number 3 (Wednesday, January 5, 1994)] [Notices] [Pages 610-615] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-125] [[Page Unknown]] [Federal Register: January 5, 1994] ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION [Docket No. 030-01244, License No. 06-00819-03, EAs 92-241 and 93-016] Yale-New Haven Hospital, New Haven, Connecticut; Order Imposing Civil Monetary Penalties I Yale-New Haven Hospital (Licensee), New Haven, Connecticut, is the holder of Byproduct Material License No. 06-00819-03 (License), issued by the U.S. Nuclear Regulatory Commission (NRC or Commission). The License was most recently amended on September 15, 1993. The License authorizes the Licensee to perform diagnostic and therapeutic procedures with radioactive material as well as research in accordance with the conditions specified therein. This is a broad scope license. The License was most recently renewed on August 13, 1985, and was due to expire on August 31, 1990 but was extended by the NRC pending staff action on the Licensee's renewal request. Based on the Licensee's application to renew the License dated June 17, 1990, and pursuant to 10 CFR 30.37(b), the existing License has not expired and continues in effect. II Between December 3, 1992, and January 27, 1993, the NRC performed two inspections of licensed activities at the Licensee's facility. The inspections were conducted to review two incidents involving therapeutic misadministrations and a failure to control licensed material that occurred between November 30 and December 1, 1992, and on January 21, 1993. During the inspections, five violations of NRC requirements were identified. A written Notice of Violation and Proposed Imposition of Civil Penalties (Notice) was served upon the Licensee by letter dated April 26, 1993. The Notice states the nature of the violations, the provisions of the NRC's requirements that the Licensee had violated, and the amount of the civil penalties proposed for the violations. The Licensee responded to the Notice on June 10, 1993. In its response, the Licensee denies Violations II.A and II.B set forth in the Notice; questions the Severity Level classification for Violations I.A, I.B, and I.C; and requests reduction of the civil penalties. III After consideration of the Licensee's response and the statements of fact, explanation, and argument for mitigation contained therein, the NRC staff has determined, as set forth in the Appendix to this Order, that the violations did occur, the Severity Level classifications were appropriate, and the penalties proposed for the violations designated in the Notice should be imposed. IV In view of the foregoing and pursuant to section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205, It is hereby ordered that: The Licensee pay civil penalties in the amount of $10,000 within 30 days of the date of this Order, by check, draft, money order, or electronic transfer, payable to the Treasurer of the United States and mailed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555. V The Licensee may request a hearing within 30 days of the date of this Order. A request for a hearing should be clearly marked as a ``Request for an Enforcement Hearing'' and shall be addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, with a copy to the Commission's Document Control Desk, Washington, DC 20555. Copies also shall be sent to the Assistant General Counsel for Hearings and Enforcement at the same address and to the Regional Administrator, NRC Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406. If a hearing is requested, the Commission will issue an Order designating the time and place of the hearing. If the Licensee fails to request a hearing within 30 days of the date of this Order, the provisions of this order shall be effective without further proceedings. If payment has not been made by that time, the matter may be referred to the Attorney General for collection. In the event the Licensee requests a hearing as provided above, the issues to be considered at such hearing shall be: (a) Whether the Licensee was in violation of the Commission's requirements as set forth in Violations II.A and II.B in the Notice referenced in section II above, and (b) Whether, on the basis of such violations and the other violations set forth in the Notice of Violation that the Licensee admitted, this Order should be sustained. Dated at Rockville, Maryland, this 27th day of December 1993. For the Nuclear Regulatory Commission. James Lieberman, Director, Office of Enforcement. Appendix--Evaluations and Conclusion On April 26, 1993, a Notice of Violation and Proposed Imposition of Civil Penalties (Notice) was issued for violations identified during two NRC inspections. The Licensee responded to the Notice on June 10, 1993. The Licensee denied Violations II.A and II.B; questioned the Severity Level classification of Violations I.A, I.B, and I.C; and requested reduction of the civil penalties. The NRC's evaluations and conclusions regarding the Licensee's requests are as follows: Restatement of Violations--Section I I.A. Condition 23 of License No. 06-00819-03 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in an application dated December 13, 1984. Item 7 of that application, dated December 13, 1984, states that the Hospital Radioisotope Committee has the responsibility of establishing and enforcing the Hospital's Radiation Safety Program to ensure the safety and welfare of hospital personnel and property as well as protecting the surrounding community from the potential hazards of sources of ionizing radiation used at the hospital. A procedure of the Hospital's Radiation Safety Program entitled, ``Procedure for Nursing Care of Patients Containing Radioactive Sources for Therapy'', requires, in part, that ``during nursing care procedures, the nurse must check all materials used by the patient . . . for radioactive sources that may have become dislodged,'' and that ``everything used by the patient (except dishes) must be saved and monitored before disposal.'' Contrary to the above, the Hospital Radioisotope Committee did not enforce the Hospital's Radiation Safety Program to ensure safety and welfare of hospital personnel and property as well as protecting the surrounding community from the potential hazards of all sources of ionizing radiation used at the hospital. Specifically, on November 30 and December 1, 1992, nurses on the ninth floor of Yale- New Haven Hospital removed linen pads from a brachytherapy patient's room without first checking the pads for radioactive sources which may have become dislodged and failed to survey the linen pads before disposal. B. 10 CFR 20.207(a) requires that licensed materials stored in an unrestricted area be secured against unauthorized removal from the place of storage. 10 CFR 20.207(b) requires that licensed materials in an unrestricted area and not in storage be tended under constant surveillance and immediate control of the licensee. As defined in 10 CFR 20.3(a)(17), an unrestricted area is any area access to which is not controlled by the licensee for purposes of protection of individuals from exposure to radiation and radioactive materials. Contrary to the above, on December 1 and 2, 1992, licensed material consisting of a 35 millicurie cesium-137 brachytherapy source was located, at various times, in unrestricted areas, namely, a hallway on the ninth floor of the hospital, the laundry collection area of the hospital, and a contractor's laundry facility; and at those times, the brachytherapy source was not under the constant surveillance and immediate control of the licensee. C. 10 CFR 20.105(b) requires, in part, that except as authorized by the Commission in 10 CFR 20.105(a), no licensee allow the creation of radiation levels in unrestricted areas which, if an individual were continuously present in the area, could result in his receiving a dose in excess of 2 millirems in any one hour or 100 millirems in any seven consecutive days. Contrary to the above, on December 1 and 2, 1992, the licensee allowed the creation of radiation levels, at various times, in unrestricted areas, namely, in a hallway on the ninth floor of the hospital, in the laundry collection area of the hospital, and a contractor's laundry facility, such that if an individual were continuously present in the area, he could have received a dose in excess of 2 millirems in any one hour or 100 millirems in any seven consecutive days. These violations are classified in the aggregate as a Severity Level III problem. (Supplements IV and VI) Civil Penalty--$2,500 Summary of Licensee Response to the Violations in Section I The Licensee, in its response, states that the safety significance of the loss of the source was minimal, noting that the potential absorbed dose to any member of the general public as a result of this incident was well below regulatory limits. Further, the Licensee argues that the possibility of public exposure was minimized by the hospital's prompt search for and discovery of the source. The Licensee believes that personnel and members of the public who may have been exposed to the source received only a minimal dose as a result of this incident, noting that its calculations indicate that the maximum dose to any exposed individual was unlikely to have exceeded a total of 30 millirems. While the Licensee recognizes that, under postulated worst case conditions, the exposure rate at distances less than 2.4 meters could have exceeded the NRC's applicable limits for the general public, the Licensee argues that this exposure condition would only have existed for very short periods of time, on the order of several minutes, and with the bulk of the postulated exposure at a dose rate well below NRC's standards for the general public. The Licensee also notes that the source was located in linen that was removed from a patient's room, and that since the linen is treated as a biologically hazardous waste, it is highly unlikely that a person would have any extended contact with the source once it had left the patient's room. The Licensee states that immediately upon discovery that a source was missing, the Radiation Safety Officer, and the resident physician who misplaced the source, conducted a search that promptly located and safely recovered the missing source. The Licensee further contends that despite this corrective action, the NRC chose to treat the sequential consequences which flowed from the initial failure as separate violations which could be treated in the aggregate and escalated to a Severity Level III problem. In addition, while the Licensee recognizes the NRC's authority to cite for each separate violation, the Licensee believes that the circumstances of the violations do not represent a programmatic breakdown in its radiation safety program, and even when aggregated, do not have the safety or regulatory significance to be considered a Severity Level III problem. The Licensee argues that the 100 percent escalation of the civil penalty was not warranted since the Notice makes reference to an incident that occurred in 1989. The NRC's enforcement policy states that a licensee's prior performance normally refers to a period within the last two years of the inspection at issue, or the period within the last two inspections; whichever is longer. The Licensee concludes by requesting that the NRC exercise its discretion to reduce the civil penalty associated with the violations in Section I of the Notice. NRC Evaluation of the Licensee Response to Violations in Section I While the NRC agrees that the doses to members of the general public resulting from the loss of the source were small, the source was, nonetheless, missing for a period of time in excess of twenty- three hours. During that time, the source was in the hallway outside the patient's room for at least seventeen hours, in a basement laundry closet and in a laundry service truck for at least an hour each, and on the floor of the laundry facility or in the laundry washing machine for at least four and one half hours. None of these locations was controlled by the Licensee for the purposes of radiation protection. Therefore, since the radiation levels were in excess of applicable levels for unrestricted areas for periods of hours, this created a significant potential for an exposure in excess of regulatory limits to personnel or members of the public, and the NRC maintains that this is a significant lack of control of licensed material. As noted in Section C.1 of Supplement VI of the Enforcement Policy, violations involving a failure to control access to licensed materials for radiation purposes (as specified in the NRC requirements) constitute Severity Level III violations. Therefore, Violation I.B could have been individually classified at Severity Level III. However, the NRC chose to aggregate the Licensee's violation in failing to control licensed material with its root cause (failure to survey--Violation I.A) as well as the effect of the violation (the creation of radiation levels in excess of that allowed in NRC regulations--Violation I.C) since the three violations were all related to the one incident. In view of the above, the assertion that Violations I.A, I.B, and I.C were classified in the aggregate at Severity Level III because they represent a programmatic breakdown is incorrect. In addition, the Licensee's contention regarding corrective action, involving the prompt location and recovery of the source are not controlling in determining the severity level of the violation. The severity level is determined by the safety or regulatory significance of the violation. The Licensee's request for mitigation of the civil penalty is discussed below. In conclusion, the violations were properly classified in the aggregate as a Severity Level III problem. Restatement of Violations--Section II II.A. 10 CFR 35.32(a) requires, in part, that each licensee shall establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. Pursuant to 10 CFR 35.32(a)(4), the quality management program must include written policies and procedures to meet the objective that each administration is in accordance with the written directive. Contrary to the above, as of November 30, 1992, the licensee's quality management program did not include written policies and procedures to meet the objective that each administration was in accordance with the written directive. In particular, the licensee did not establish written procedures to identify if a brachytherapy source was not properly implanted or inadequately secured against accidental removal. As a result, on November 30, 1992, during a therapy procedure that involved a gynecological implant of four cesium-137 sources, one source was either not implanted as required or it was implanted properly but inadequately secured because the source came out of the applicator and lay undetected in the patient's bed. As a result, the dose administered to the patient was less than that prescribed by the physician and the patient received a radiation dose to the leg, an area not intended to receive radiation. B. 10 CFR 35.32(a)(4) requires, in part, that each licensee shall establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The quality management program must include written policies and procedures to meet the specific objective that each administration is in accordance with the written directive. On January 27, 1992, the licensee implemented a quality management program for the use of byproduct material. Section 3 of the quality management program entitled ``Policies and Procedures for Brachytherapy'', paragraph 3.1.3 of the ``High Dose Rate Remote Afterloading Devices'', requires, in part, that the treatment site be confirmed with the written directive and treatment plan by the administering person before administration of the treatment dose. Contrary to the above, on January 21, 1993, the authorized user physician failed to follow the quality management program in that during a brachytherapy patient treatment with a high dose rate remote afterloader, the treatment site was not confirmed by the authorized user physician, causing the patient to receive 700 rads to the rectum, instead of the vagina, as prescribed in the written directive. These violations are classified in the aggregate as a Severity Level III problem (Supplement VI). Civil Penalty--$7,500 Summary of Licensee Response to Violations in Section II In its response, the Licensee denies that it violated the requirement to establish and maintain a written QMP, noting that it established a written QMP based upon the NRC's own guidance published in Regulatory Guide 8.33 on January 27, 1992, and as required by 10 CFR 35.32(a)(4). The Licensee further states that the written quality management policy and procedures were distributed to all authorized users for comment on January 21, 1992, and no comments were received from the authorized users on this final version, and the same version was presented to NRC Region I in a letter dated January 27, 1992. The Licensee also notes that in addition to giving each authorized user a copy of the written quality management policy and procedures, the radiation safety officer conducted formal training for the members of the radiation therapy staff on March 5, 1992, detailing the requirements of the QMP, and both physicians involved in the alleged violations attended this presentation. The Licensee further states that both physicians understood that the written directive needed to be verified during the application process. Nonetheless, despite the existence of a comprehensive QMP and related training, these events occurred. With respect to the first incident, the Licensee also states that the resident physician followed the established procedures and, therefore, reasonably concluded that he had successfully placed the sources in the applicator during the loading process, and he and the dosimetrist identified the correct sources as they were moved from the transportation shield. The Licensee stated that in the process of moving one of the four sources and its applicator to the patient, the source inadvertently slipped unnoticed from the applicator, and that since the resident missed the source in its fall under the patient, he had no opportunity to identify the error once the applicator was placed into the Fletcher Suit Device (FSD). Since the resident wholly believed he had fulfilled the written directive, the Licensee submits that he had satisfied the requirements of the QMP regardless of his error. With respect to the second incident involving the High Dose Rate Afterloading (HDR) device, the Licensee states that the physician who prepared the written directive was the same physician who placed the applicator in error. Since he was the prescribing physician, the Licensee contends that there is no doubt that he understood the intent of the written directive. The Licensee states that while the physician did not visually confirm or verify the placement, he fully believed that he had correctly placed the applicator, based on his sense of touch during the physical examination, knowledge of anatomy, the feel and depth of the applicator insertion, and by asking the patient if she felt comfortable after the placement. Since the physician fully believed that he had carried out the written directive, the Licensee submits that it had fulfilled the requirements of the QMP notwithstanding his error. NRC Evaluation of Licensee Response to Violations in Section II The NRC does not dispute, in general, that the Licensee established and maintained a QMP, or that it provided training to authorized users. However, with respect to the first incident, the NRC maintains that the Licensee's QMP did not include written policies and procedures to provide high confidence that the QMP would meet the objective that each brachytherapy administration is in accordance with the written directive. 10 CFR 35.32(a) requires, in part, that each licensee shall establish and maintain these written policies and procedures to provide high confidence that the radiation from byproduct material will be administered as directed by the authorized user. Therefore, it is incumbent upon the Licensee to establish written procedures that provide high confidence in the delivery process of therapeutic radiation and the accurate administration of the prescribed dose. In this case, the Licensee did not establish adequate written procedures, as required, to effectively implement their QMP and procedures to verify whether brachytherapy sources were properly inserted in accordance with the written directive. In particular, the QMP was inadequate in that it did not require visual or other verification of proper insertion of the sources while they were being inserted. The Licensee stated that it established a QMP based on requirements in 10 CFR 35.32. 10 CFR 35.32(a)(4) requires that each administration be in accordance with the written directive. The licensee's QMP did require that a means be employed of verifying sources are positioned properly. However, the licensee had not established such a procedure to meet this objective by directing the physician to verify proper insertion of the source or sources (e.g., by visual inspection). In this instance, visual verification of the sources in the applicator would have been an acceptable means. The QMP did not have any procedure to ensure, nor did the physician confirm, that the administration of the dose was in accordance with the written directive. Therefore, the QMP did not provide high confidence that radiation from byproduct material would be administered as directed pursuant to 10 CFR 35.32(a). With respect to the second incident, although the authorized user fully understood the intent of the written directive, the individual did not confirm or verify the proper placement of the applicator, which had not been placed into the correct organ, with the treatment site specified in the written directive and treatment plan. The Licensee stated that it established a QMP based on requirements in 10 CFR 35.32. 10 CFR 35.32(a)(4) requires that each administration be in accordance with the written directive but did not describe how this should be done. The licensee's QMP did require the treatment site be confirmed with the written directive. Visual verification of the source insertion into the proper organ would have been an acceptable means. As in violation IIA, the QMP appears inadequate in that it did not require visual or another specific procedure for verification of proper insertion of the sources while they were being inserted. The QMP did not have any specific procedure to ensure, nor did the physician confirm, that the administration of the dose was in accordance with the written directive. Therefore, the QMP did not provide high confidence that radiation from byproduct material would be administered as directed pursuant to 10 CFR 35.32(a). The NRC realizes that confirmation of a treatment site by the Licensee may be accomplished in a number of ways. However, it is the responsibility of the Licensee to establish effective procedures to meet the performance-based objective of the QMP required by 10 CFR 35.32(a)(4), and provide high confidence that the intended therapeutic radiation is administered to the designated treatment site as prescribed by the physician authorized user. In this case, simple visual confirmation could have prevented the error and would have provided higher confidence than the physician's method of feeling to locate the treatment site. As demonstrated by the authorized user's failure to treat the prescribed treatment site, the Licensee did not meet the objective in 10 CFR 35.32(a)(4). The NRC agrees that the Licensee had a QMP and that the physician understood the intent of the written directive. The NRC has determined, however, that the procedures may have been inadequate in that the physician did not adequately confirm (or verify) the placement of the applicator and that the QMP procedure for confirmation (or verification) is vague and does not provide high confidence that the objective will be met. Accordingly, the NRC maintains that with regard to both incidents, violations of the QMP occurred. Summary of Licensee Response Requesting Mitigation of the Civil Penalties As a general comment to violations identified in Sections I and II of the Notice, the Licensee contends that the civil penalties should be reduced, noting that it has voluntarily conducted an independent, formal, and comprehensive review of the hospital's radiation safety program, and a panel of four experts conducted the review on May 10 and 11, 1993. The Licensee also notes, as evidenced by this formal review program, and other comprehensive measures detailed in its incident reports dated December 22, 1992, January 4, 1993, and February 5, 1993, that it is committing significant management and fiscal resources to address the concerns expressed in the enforcement action. The Licensee believes that the remedial actions that the NRC seeks to encourage will be realized without the need for stringent enforcement in the form of proposed civil penalties, and that this is consistent with the Enforcement Policy. With respect to the violations in Section I, as stated above, the Licensee notes that the NRC letter stated that 100 percent escalation of the civil penalty was warranted based upon the hospital's past enforcement history. Since the letter makes reference to an incident which occurred in 1989, the Licensee questions consideration of that action since the NRC's Enforcement Policy indicates that a licensee's prior performance normally refers to a period within the last two years of the inspection at issue, or the period within the last two inspections, whichever is longer. Since this license is a broad scope license that is inspected on a yearly interval, the Licensee believes it is contrary to established NRC practice to cite an incident occurring more than three and a half years ago as a basis for escalation of the civil penalty. Further, since the NRC's current Enforcement Policy has been modified to provide for maximum flexibility and consideration of all mitigating circumstances, the Licensee requests that the NRC exercise its discretion to reduce the civil penalty associated with the violations in Section I of the NOV. With respect to the violations in Section II, the Licensee states that the NRC's cover letter to the NOV indicates that all of the adjustment factors set forth in 10 CFR Part 2, Appendix C, were considered. Although the NRC increased the base civil penalty by 200 percent for ``past enforcement history and multiple examples,'' and concluded that the remaining factors warranted no further adjustment, the Licensee believes that, upon closer examination of the circumstances, mitigation is warranted. Regarding the ``multiple examples'' adjustment factor, the Licensee notes that the NRC's Enforcement Policy makes it explicitly clear that for this factor to be applicable, the multiple occurrences should have the ``same root causes.'' The Licensee contends that while the NRC indicated that the root cause of the two incidents was inattention to detail by the treating physicians, this is not the root cause of the cited violations. The Licensee notes that the NOV states that the root cause of Violation II.A was failure to have an adequate procedure in place consistent with the program requirements in 10 CFR 35.32, whereas the second violation, II.B, is stated by the NRC to arise from a different root cause, namely, failure to follow an existing procedure established in conformance with the program requirements of 10 CFR 35.32. The Licensee further states that the fact that these violations derive from different root causes is reinforced by the fact that the specific corrective action for one violation would not necessarily have prevented the other. Based on this information, the Licensee believes that escalation of the base civil penalty under the ``multiple examples'' factor is inappropriate. Regarding the ``prior enforcement history'' adjustment factor, the Licensee believes that the application of this factor was inappropriate in this case, noting that the Quality Management rule has become effective only recently, and there has been no opportunity to develop an enforcement history for compliance with this rule. Just as the Enforcement Policy recognizes that this factor should not be applied where the Licensee has not been in existence long enough to establish a performance history, the Licensee contends that so too should this logic be applied in establishing performance history for quality management violations. On this basis, the Licensee contends that escalation of the base civil penalty is unwarranted. Regarding the other factors, the Licensee believes that, on balance, the remaining adjustment factors warrant mitigation even though none was applied. Regarding the ``identification'' factor, the Licensee notes that the current Enforcement Policy streamlines the applicability of this factor to situations where the Licensee identified the violations and promptly reported them to the NRC. The Licensee argues that, in both cases, following identification of the violation, the hospital thoroughly evaluated the events and promptly provided the NRC with the results in letters to the NRC Region I office, dated December 22, 1992, January 4, 1993, and February 5, 1993. Based on this information, the Licensee believes that full mitigation on this factor is warranted. Regarding the ``corrective action'' factor, once the violations were identified, the Licensee maintains it took prompt action to bring the situations into compliance. Immediate corrective actions were implemented to assure that fully safe conditions were restored and that further noncompliance with the NRC's requirements was halted. In addition, as evidenced by the NRC's inspection report dated December 30, 1992, the Licensee maintains that it had already developed proposed long-term corrective actions, ``at the time of the inspection,'' which was the day after the incident was reported. Given this information, the Licensee believes that further mitigation due to this factor is warranted. Finally, the Licensee maintains it had no prior opportunity to identify the two specific violations, neither misadministration resulted in doses to the patients that exceeded the prescribed doses by more than 20 percent of the total prescribed doses, nor are they believed to result in any significant detriment, and therefore, no escalation is warranted for these factors. In summary, when the circumstances surrounding the violations are fully considered, the Licensee submits that significant mitigation of the proposed civil penalty for Violation II is warranted. NRC Evaluation of Licensee Response Requesting Mitigation of the Civil Penalties The NRC has evaluated the Licensee response and has determined, as set forth below, that the Licensee has not provided an adequate basis for any mitigation of the civil penalty. In determining the amount of the civil penalty, the NRC considered the escalation and mitigation factors set forth in the NRC Enforcement Policy. With respect to the issues provided in the Licensee's response as a basis for mitigation of the penalty, the NRC acknowledges that the Licensee performed an independent assessment on May 10 and 11, 1993, to improve implementation of the radiation safety program. However, this commitment was made only after these violations were identified by the NRC as a result of inspections conducted on December 3 and 4, 1992, and January 26 and 27, 1993, at the Licensee's facility. Nevertheless, the NRC mitigated the base civil penalty for corrective action for Violations I.A, I.B, and I.C by 50 percent, the maximum recommended under the enforcement policy. No further mitigation is warranted under this factor. With respect to the violations in Section I, the Licensee states that the NRC, contrary to established practice in Section VI.B.2.(c) of the Enforcement Policy, used an enforcement action which occurred in 1989 as part of its inspection history to establish a basis for the 100 percent escalation of the civil penalty for licensee performance. The NRC agrees that prior performance normally refers to the licensee's performance within the last two years of the inspection at issue, or the period within the last two inspections, whichever is longer. However, Section VI.B.2.(c) also states that the base civil penalty may be escalated by as much as 100 percent if the current violation is reflective of the licensee's poor or declining prior performance. While the NRC did mention the escalated action issued in 1989 in its April 26, 1993, cover letter to the Notice of Violation, it also referred to an escalated action that was issued in 1992, which is within the two year/two inspection period. Viewed collectively, the past enforcement actions demonstrate a declining trend in performance at the Licensee's facility. Additionally, the escalated enforcement action issued in 1989 involved the Licensee's loss of control of a cesium-137 sealed source and subsequent improper disposal. The Licensee's corrective action for this incident was not broad and lasting, and did not prevent recurrence of a similar violation described in Section I of the Notice issued April 26, 1993, involving the loss of a cesium-137 brachytherapy sealed source. Based on the above, the NRC believes that the 100 percent escalation for Licensee performances, was a proper application of the Enforcement Policy in determining the civil penalty amount of $2500 for the violations in Section I. As for the Licensee's contention regarding identification of Violations I.A, I.B, and I.C, the NRC in the Notice proposed 50 percent mitigation, which is the maximum recommended under the enforcement policy. The escalation/mitigation factors for the violations in Section II were applied consistent with the Policy. Regarding the ``multiple examples'' factor, the violations both involved the failure to meet the specific objective that each administration is in accordance with the written directive. The QMP was inadequate in that it did not contain procedures that provide high confidence in the delivery process of therapeutic radiation and the accurate administration of the prescribed dose. The administering physician's inattention to detail was the root cause and primary contributing reason for the occurrence of both misadministrations at the facility within a short period. In violation II.A, the physician failed to observe that one of four sources fell into the patient's bed, while in violation II.B, the physician failed to use any visual means to verify correct insertion of the sources. Had either physician paid adequate attention while inserting the sources, or if the Licensee's QMP had provided specific procedures to verify correct source insertion, these violations would likely have been averted. Therefore, based on the fact that both events were due to the same root cause, escalation on this factor was warranted. With respect to the ``prior performance'' factor, while there is no history in the quality management area given its recent implementation, the Licensee's poor and declining overall performance in the radiation safety area of the medical program warrants escalation of the penalty on this factor, as set forth above. Regarding the ``identification'' factor, the NRC maintains that, while the two misadministrations were self disclosing, the associated quality management violations were identified by the NRC. In both events, the Licensee did not identify the failure of the QMP to include written policies and procedures to meet the objective that each brachytherapy administration is verified to be to the proper treatment site in accordance with the respective written directive. In each case, the NRC identified the failure to establish adequate written procedures to ensure the Licensee's proper placement of brachytherapy source(s) at the prescribed treatment site. Therefore, on balance, no adjustment by the NRC on this factor was warranted. With respect to the ``corrective action'' factor, the actions taken in response to these violations were not considered sufficiently prompt and comprehensive to warrant mitigation because they were initially narrowly focused on the specific events, rather than on root causes, the QMP and improvements necessary to increase management oversight. The Licensee did implement additional training and instruction in the loading and placement of brachytherapy sources and applicators. However, the Licensee did not perform an extensive and comprehensive root cause analysis of the two misadministrations. The corrective actions were narrowly focused and primarily directed at the performance of visual checks and examinations of the sources and applicators before implantation. The corrective actions did not include a comprehensive review of the QMP procedures to determine what written modifications might be necessary to ensure compliance with the failed objective and program areas of concern. Additionally, the corrective actions failed to address what changes in management oversight and involvement would be incorporated into the Licensee's QMP to prevent recurrence of similar events and improve supervision of brachytherapy activities. Following the second event and discussions with NRC, a more comprehensive approach was adopted. However, on balance, no adjustment on this factor is warranted. NRC Conclusion The NRC concludes that the Licensee has not provided an adequate basis for mitigating any portion of the civil penalties. Accordingly, the NRC has determined that monetary civil penalties in the amount of $10,000 should be imposed. [FR Doc. 94-125 Filed 1-4-94; 8:45 am] BILLING CODE 7590-01-M