ML20055C936
| ML20055C936 | |
| Person / Time | |
|---|---|
| Issue date: | 06/21/1990 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Eckart D HOUSE OF REP. |
| Shared Package | |
| ML19327C523 | List: |
| References | |
| CCS, NUDOCS 9007020064 | |
| Download: ML20055C936 (7) | |
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UNITED STATES eq 7,
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June 21, 1990 The Honorable Dennis E. Eckart itember, United States House of Representatives 5870 Heisley Road #20 l
fientor, OH 44080-1872 l
Dear Congressman Eckart:
I am responding to your flay 23, 1990 letter to Mr. Dennis Rathbun, Director, i
Congressional Affairs, Nuclear Regulatory Commission (NRC) in which you
.i requested information regarding the status of the NRC license issued to Advanced Medical Systems, Inc. (AMS).
The NRC first issued a license to AMS in November 1979. The license authorizes AMS to manufacture sealed sources containing significant amounts (thousands of curies) of radioactive cobalt to be placed in teletherapy units.
The teletherapy units are used in medical facilities to treat patients.
The i
license also authorizes AMS to service and repair the teletherapy units.
The AMS license has continued, uninterrupted, through the present except for the l
period October 10 -1986 through February 2, 1987. During this period, a portion of the license which authorized servicing of teletherapy units, was suspended for. safety reason 3.
In the case of teletherapy service companies, such as AMS, the NRC license is based upon NRC's determination that the licensee'.s procedures, equipment, facilities and staff experience and qualifications are adequate to protect health and minimize danger to licensee workers, medical staff using teletherapy units, and the public.- Once the initial license is issued, the NRC reviews any proposed changes to the licensee's program and makes a determination as to whether these will be incorporated into the license. The NRC also requires licensees to evaluate their programs and resubmit any necessary changes as part of a license renewal process every 5 years. AMS submitted a timely request for renewal of its license in 1984 and, as a result, was allowed to continue to operate in accordance with procedures approved-as part of the initial licensing process, as provided for in NRC regulations.
However, the actual license L
renewal was issued in December 1989 after a determination that the licensee's I
revised procedures, facilities (including decontamination as ordered by the L
NRC), and new personnel were adequate. Because of the significant amounts of l
materials authorized by this license, the AMS' submissions to show adequacy are extensive and these documents are all referenced in the license.
The AflS program is inspected, as a minimum, on an annual basis and in response to events in accordance with flRC normal procedures for licensees of this type.
The inspections of AMS licensed activities have identified a number of safety i
problems since 1983 which the NRC has required to be corrected through normal FULL TEXT ASCil SCAN F
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The Honorable Dennis E. Eckart 2
procedures. Many of the issues raised by AMS in the letter submitted with your letter to Mr. Rathbun are connected with these inspections and NRC actions.
AMS has raised many of these in correspondence with the NRC Region III steff.
A summary of inspection and enforcement issues and a more detailed response to the specific concerns raised by AMS to you are enclosed for your information.
Regarding lis. Stein's allegation that Region III officials have taken action in retaliation for'AMS' refusal to dismiss its administrative claims, the flRC Inspector General has been in contact with fis. Stein and currently has an open investigation into the matter.
I trust this reply responds to your request.
Sincerely,
/
(.aor, Executive es Director for Operations
Enclosures:
1.
AMS Enforcement History 2.
Issues in AM 05/02/90 ltr s
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i AMS - Enforcement History r
I.
During a March 1-3, 1983 inspection of an overexposure event, inspectors I
identified violations concerning exceeding exposure limits in 10 CFR l
Part 20, improper reading of personal dosimeters, not using wrist film j
badges, not evaluating dose to hands, and not leak testing a source.
Region.III. held an enforcement conference on March 14, 1983 concerning the above inspection with the licensee.
A Notice of Violation.(NOV) and Proposed Civil Penalty (CP) in the amount of S4,000 were issued to the licencee on-May 5, 1983. The licensee adequately responded to the NOV and paid the l
CP.
i II. The licensee was inspected on July 16-17, 1984 and was issued an NOV on-August 29, 1984.
Violations included radiation levels in unrestricted areas exceeding regulatory limits and failure to post a high radiation area on the roof. The NRC also expressed concern regarding the licensee's-hot cell window, which was cracked.
A Confirmatory Action Letter (CAL) was issued to the licensee on September 14, 1984, regarding shielding techniques necessary for repair of the-licensee's hot cell window.
III. Region III conducted a special inspection on February 21-22, 1985 in response to a reported overexposure during a hot cell entry. On March 13, 1985, Region III held an enforcement conference with the licensee p
regarding the overexposure. On March 15, 1985, Region III issued a CAL to the licensee regarding procedures for hot cell entry.
l In regard to the overexposure during hot cell entry, the NRC issued an NOV and proposed a $6,250 CP-to the licensee on June 28, 1985, for exceeding 1
exposure limits, failure to perform adequate hot cell entry surveys, l
failure to read-personal dosimeters and inadequate calibration of L
dosimeters. The licensee protested this action on July 31, 1985, aut l
modified its response on May 24, 1988 to state it agreed that a violation for exceeding Part 20 limits had occurred. The Office of Investigations (01) also reviewed possible falsification of information provided in the licensee's original response to certain violations. After evaluation of the 01 investigation results and review of the licensee's response, the proposed CP in the amount of $6,250 was imposed by Order on May 30, 1989.
The licensee requested a hearing on this matter on June 20, 1989, and the hearing is pending.
IV.
During a September 17 - November 12, 1986 special inspection regarding allegations of the licensee's use of unlicensed service engineers, inspectors identified several violations concerning the use of unauthorized / unqualified users; failure to wear personnel dosimeters, audible radiation monitors and/or have operable survey meters present
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manuals present during licensed teletherapy service activities; failure to perform required safety checks following licensed teletherapy service; L
failure to conduct basic training program; and the failure to conduct semiannual refresher training.
As a result of the inspection findings, the NRC issued an Order to the licensee on October 10, 1986 which suspended authorization to perform service operations on teletherapy and radiography units. The licensee requested a hearing on this Order on October 29, 1986.
As a result-of the licensee resubmitting sufficient procedures and individual qualifica-tions, the Order was relaxed on February 2, 1987 and rescinded on December 3, 1987. 01 investigated the allegation of the use of unlicensed service engineers and the 01 report supported the violation. The hearing was terminated by the Atomic Safety and Licensing Board (ASLB) on the basis of a favorable ruling on the NRC's January 10, 1990 Motion for Summary Disposition.
V.
On October 10, 1986, the Mississippi Dept. of Health (an NRC Agreement State agency) issued an NOV to the licensee with violations for failure to properly label a source exchange container; improper exchange of a source; an improperly labeled shipping cask; an inoperable survey meter; and failure to check necessary items on a 5-year maintenance check.
VI. The NRC issued an Order to the licensee on July 23, 1987 to implement decontamination of the'AMS London Road facility in accordance with the decontamination plan in the AMS license.
A Confirmatory Order modifying the July 23, Order was issued on October 30, 1987 in accordance with a request from the licensee. The licensee requested a hearing on the July 23-Order on August-ll, 1987 and on the October 30 Confirmatory Order on November 19, 1987.
The hearing is pending.
VII. Region III conducted an inspection on November 14-18, 1988 of the safety program and organization at AMS and identified violations for failure to have outside audits of service engineer's performance and lack.of authorized individuals in key management positions. An NOV was issued to the licensee on December 12, 1988.
VIII.An inspection regarding Sodeco timers used in conjunction with the teletherapy units was conducted by Region III from September 17 -
November 12, 1986 and October 10, 1986 through March 4, 1987. An OI investigation regarding Sodeco timers was conducted from October 15, 1986 through March 10, 1989. An enforcement conference was held in Region III on September 18, 1989 to discuss the results of the inspection and investigation.
An NOV was issued to the licensee on December 27, 1989 for failure to establish and implement adequate procedures required by 10 CFR Part 21.
IX. Durino a January 22-26, 1990 routine inspection, nine apparent violations of NRC requirements were identified which collectively represent deficiencies in management control over licensed activities. An enforcement conferener: was held in Cleveland, Ohio near the licensee's facilities to discuss the results nf this inspection.
Final action in this case is pending.
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1 1ssues in AMS May 2, 1990 Letter i
1.
AMS Issue:
Region Ill suspanded AMS' license to service cobalt units without warning.
AMS was successful in having that order revoked in its entirety in 1987.
The NRC has never been able to substantiate its claim.
NRC Response:
As a result of inspection findings, the NRC issued an Order to AMS on October 10, 1986 which suspended authority to service teletherapy units.
The Order was issued for safety reasons including the use of unqualified individuals to service teletherapy units.
On February 2, 1987, the Order was relaxed, only after AMS submitted sufficient procedures and staff qualifications. The Order was rescinded in Decenber 1987 after the NRC was satisfied AMS had developed sufficient procedures and had qualified staff to operate its activities in a safe. manner and in accordance with NRC requirements.
In terminating the related-proceeding, the Atomic Safety and Licensing Board determined that there was no generic issue of material fact related to the basis for issuance of the order.
2.
AMS Issue:
AMS had to wait several years for its license renewal because the NRC had indicated that AMS' license would not be renewed until AMS dismissed all actions against the NRC.
NRC Response:
The license was not renewed due to both insufficient information provided by AMS and the incomplete resolution of safety issues (principally decon-tamination) at the facility. The NRC has issued letters to AMS explaining NRC reasons for not renewing and the NRC actions. AMS' dismissal of all actions against the NRC was not a reason for the delay in renewal.
3.
AMS Issue:
When the license was finally renewed, the license, as put together by Region III, was so cumbersone that even the individual who compiled the license confessed it was unusually obscure.
NRC Response:
The AMS license document is only a few pages long and not atypical for an NRC license nf this type. The license incorporates by reference numerous documents required to be submitted by AMS to satisfy the NRC that AMS has adequate procedures, equipment, facilities and staff to use the significant amounts nf radioactive material authorized on the license.
The ANS license was issued based upon submissions by AMS.
The NRC advised
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f.,1 AMS by letter dated March 14, 1990, that if AMS wished to simplify its f
license, AMS should submit revised and consolidated procedures.
4.
AMS Issue:
Although Region III Administrator, A. Bert Davis, finally agreed that Region III would assist in the license's streamlining, revisions sent to Region III have been returned refused.
NRC Responst.:
Mr. Davis did agree to expedite review of any AMS submittals for license revision if AMS felt they were needed to streamline the license. -This was agreed to during a March 27, 1990 enforcement conference with AMS representatives. Following receipt of a reauest from AMS to modify its license, the NRC responded to AMS in a May 23, 1990 letter and clarified that, as part of its normal practice, the AliS submissions were being returned, unreviewed, since they did not include a fee for the license amendment. This practice is applied to amendment requests from all 8000 NRC licensees.
5.
AMS Issue:
Although the Washington offices of NRC have represented that Region III's actions would be investigated, we have seen no results.
NRC Response:
Region III advised AMS, in a December 19, 1989 letter, that its allegations of negligence and incompeteace of NRC employees and of threats and harassment directed to AMS by NRC employees, were being referred to the Inspector General's Office for such action as that office deemed appropriate. The Inspector General has been in contact with AMS and currently has an open investigation into the matter.
6.
AMS Issue:
Region III has responded to our years of requesting settlement by reactivating allegations previously demonstreted as unsubstantiated.
NRC Response:
We believe AMS is referring to the issue recently-raised in AMS letters dated April 17, May 2, and May 18, 1990, to the NRC. The NRC responded to this issue in a May 23, 1990 letter which indicates the NRC is not reactivating allegations previously demonstrated as unsubstantiated.
7.
AMS Issue:
Through the yeo. legion III has persisted in bringing addittnal actions against AMS in i<.4.liation for AMS' refusal to dismiss its administrative claims. Region
.i has persisted in adoptirg an unreasonable litigous stance in the e aministrative actions.
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e-NRC Response:
-NRC has taken actions aaainst AMS for safety issues in accordance with
'the NRC enforcement policy and not in retaliation for AMS' refusal to dismiss its administrative claims. The chronology in Enclosure 1 indicates the basis for actions taken by the NP,C.
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