ML20134H012

Discusses Conversation W/H Billingsley Re Advanced Medical Sys Case

ML20134H012
Person / Time
Issue date:	11/23/1994
From:	Berson B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:	Cordes J, Crockett S, Fliegel M NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF THE GENERAL COUNSEL (OGC)
Shared Package
ML20127A948	List: IA-94-494, Discusses Handling of FOIA-94-494 from Lenhart ML20134G275 ML20134G283 ML20134G616 ML20134G659 ML20134G670 ML20134G676 ML20134G752 ML20134G878 ML20134G896 ML20134G939 ML20134G980 ML20134H012 ML20134H043 ML20134H198 ML20134H237 ML20134H247 ML20134H271
References
FOIA-96-444 NUDOCS 9702110118
Download: ML20134H012 (1)

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! From: Bruce A. Berson (BAB1)

To: JFC, SFC, leiF Date: Wednesday, November N.r 0 6 C [(/2o f

3, 1994 8:57 am g

Subject:

AMS 4

I heard from the AMS attorney Henry Billingsley late yesterday afternioon. He will be filing a Touhy request with Karen. Attn John for live testimony or at 4

least an affidavit from NRC to the effect that NRC has the authority to shut drwn a licensee if NRC concludes there is an immediate threat to public health and safety from radiological discharges and that based on the Information NRC l has to date that it has no cause to do so. As you know, the hearing is scheduled for December 9. I also gave him him your phone and fax numbers, John.

i I told him that I thought it would be doubtful that we would provide a 1ive witness but that an affidavit of some type might be possible. I sudgested that

' he include in his Touhy request a draft of something that he would like to see and told him that should we grant the request we would obviously feel free to  ;{

modify it to reflect the agency position. Until we see the actual request it i 1

will be hard to determine who the appropriate NRC person to execute the affidavit would be, but my initial reaction is that it should be from a regional or HDs NMSS division director.

John, he will also be sending copies of the pleadings to you and me. He stated that he views the TTIO and the underlying state court trespass proceeding for damages as preempted and referred to decisions in the 3rd and 7th circuit whIch he said hoId that the Price Anderson Act Amendments bar any state damage g proceedings for federally regulated radioactive releases. He has filed a I motion to dismiss the underlying trespass proceeding on this basis, but the judge has not ruled. He also expressed the view that that NRC should be concerned that if the sewer district prevails in this case, any sewer district in the country could shut down hospitals etc, all of which make discharges to the sewers.

CC: CJP1, RfE1, RJC1, JAG, WLA I

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g i 9702110118 970129 E PDR FOIA E ENGLISH96-444 PDR j

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a l November 29, 1994 Advanced Medical Systems, Inc.

ATTN: David Cesar

. Treasurer 121 North Eagle Street l Geneva,.OH 44041 I

Dear Mr. Cesar:

This refers to the routine safety inspection conducted by Mr. Wayne Slawinski of the NRC Region III office and Mr. Robert Shewmaker of our headquarters

office on October 11-12, 1994, to review certain aspects of your NRC licensed activities uthorized by NRC Byproduct Material License No. 34-19089-01. This

also refers to the discussion of our findings with Robert Meschter at the j conclusion of the site inspection on October 12, 1994 and to the telecon with you on October 21, 1994.

The inspection was limited in scope and included a review of: (1) the

implementation of your Radiologickl Emergency Contingency Plan; 4

(2) information relative to assessing the Waste Holdup Tank (WHUT) room's structural integrity; and (3) recent facility water usage practices. The inspectors also met with Cleveland Firo Departent representatives at your

facility to discuss their readiness to responc to an event at your facility.

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' The eh,:losed copy of our inspection re) ort identifies areas examined during the inspection. Within these areas, tie inspection consisted of a selective ,

e:tamination of procedures and representative records, observations, and '

4 interviews with personnel. Our assessment of the WHUT room's structural j integrity is continuing. Assessment results will be provided under separate j cover upon completion of our review.

1 During this inspection, certain of your activities were found to be in i violation of NRC requirements, as specified in the enclosed Notice. In ,

addition to the violations, we also identified the following other concerns during the inspection.

(1) The only available emergency contact person listed in your Radiological

, Contingency plan who provides backup to the IT is not sufficiently familiar with the plan.

l (2) The Director of Regulatory Affairs has key responsibilities in the implementation of the Radiological Contingency Plan, including being listed as a backup emergency contact; however, this individual has been on leave for more than one year and no other individual has fulfilled the director's role under this plan.  ;

(3) Your staff has not interfaced sufficiently with the Cleve' land Fire Department and other response organizations, to ensure they have an th adequate understanu~ lng of your Rulological Contingency Plan and the facility. I i

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(4) While routine radiation and contamination surveys are conducted in the i,

vicinity of the WHUT room area, the specific WHUT room surveillances and

radiation surveys described in your February 8,1988 letter to the NRC j have not been conducted. ,

l In addition to your response to the violations, please also respond to the '

four concerns noted above, indicating your corrective action and actions to prev nt recurrence. Of particular concern is the status of your readiness to l respond to an emergency. While we believe that your RS0 is competent to '

respond to and support emergency response activities, the available backup for j the RS0 listed in your contingency plan is not fully cognizant of the plan.

1 It appears that your management oversight of this important aspect of your i program has been ineffective. This area requires your prompt attention to l ensure you have: (1) a properly trained staff in emergency response i positions; (2) appropriate equipment and supplies available; (3) effective ,

audits and exercises to assess emergency response readiness; and (4) a

} productive relationship with offsite emergency response organizations. -

Please ensure your response addresses these areas.

l I In accordance with 10 CFR 2.790 of the Commission's regulations, a copy of this letter, the enclosures, and your response to this letter will be placed  ;

i in the HRC Public Document Room.  :

The response directed by this letter and the accompanying Notice are not i subject to the clearance procedures of the Office of Management and Budget as  ;

! required by the Paperwsrk Reduction Act of 1980, PL 96-511.  :

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j We will gladly discuss any questions you have concerning this inspection.  :

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Sincerely, '

l Original signed by John A. Grobe )

John A. Grobe, Chief Nuclear Materials Inspection Section 2 License No. 34-19089-01 Docket No. 030-16055

Enclosures:

1. Notice of Violation

2. Inspection Report No. 030-16055/94004 bec w/encls: Robert Meschter, AMS Capt. Thomas Root, Fire Marsh]alte d W.$~d .T. C&-.*"

b 0 % . *6 Cleveland Fire Department va.A* h ,eg.

PUBLIC IE07

• OCUMENT NAME: G: 03 .

<. . n.em..i \lNSPRPTS\.MTLS\030\.n.016055.941

.i i. w c .c ,.n u a r - c n .e .u.a e.ncio... w . w. n, OFFICE MGSS/RIII l6 DRSS/RIII 8 DRSS/RIIL 3 &

NAME /R WSLAWINSKI: jaw- JMADE W h JAGROBE(# T DATE F11/f\/94 ll/A1/54 II/M/94 I ~

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NOTICE OF VIOLATION Advanced Medical Systems, Inc.

Cleveland, Ohio License No. 34-19089-01 Docket No. 030-16055

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During an NRC inspection conducted on October 11-12, 1994, violations of NRC requirements were identified.

In accordance with the " General Statement of Policy and Procedure for Hilt Enforcement Actions," 10 CFR Part 2, Appendix C (1994), the violations a listed below:

License Condition 18 re ires that the licensee maintain and execute the response measures of theli Emergency Plan dated October 25, 1991 and revised January 1992, May 27, 1992 and April 26, 1993.

A.

Item 7.3 of the "Onsite Radiological Contingency Plan For The Cleveland,  !

Ohio Facility," revised May 27, 1992 and April 26, 1993, requires that the licensee conduct a full scale biennial exercise with offsite emergency response personnel.  !

Contrary to the ebove, f.wm inception of this requirement in July 1992 to the date of this inspection on October 12 1994 no full scale exercise involving offsite emergency response, perso,nnel has been conducted.

This is a Severity Level IV violation (Supplement VI).

B.

Item 7.5 of the "Onsite Radiological Coritingency Plan For The Cleveland, Ohio Facility," revised May 27, 1992 and April 26, 1993, requires that the licensee conduct an annual audit to review the emergency response program, emergency plan procedures, training, equipment and supplies.

Contrary to the above, from inception of this requirement in July 1992 to the date of this inspection on October 12 1994, no licensee audits of the emergency response program, emergency, plan procedures or training has been performed.

This is a Severity Level IV violation (Supplement VI).

C. Items 6.3 and 6.4 of the "Onsite Radiological Contingency Plan For The Cleveland, Ohio Facility," revised May 27, 1992 and April 26, 1993, list the emergency response equipment and supplies located in the fire pumphouse. Item 7.6 requires that fire pumphouse emergency equipment and supplies be inventoried and checked quarterly, and that inoperable or missing equipment be repaired / replaced as soon as possible.

Contrary to the above, on October 12, 1994, certain emergency response supplies required to be located in the fire pumphouse were not avail able. Specifically, supplies absent included building keys,.a current listing of emergency response personnel and corresponding telephone numbers, and $3.00 in quarters for pay phone use.ge.

This is a Severity Level IV violation (Supplement VI).

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Notice of Violation 2 l

Pursuant to the provisions of 10 CFR 2.201, Advanced Medical Systems, Inc. 1 is hereby required to submit a written statement or explanation to the U.S.  ;

Nuclear Regulatory Commission, Region III, 801 Warrenville Road, Lisle, '

Illinois, 60532-4351, within 30 days of the date of the letter transmitting {

this Notice of Violation (Notice). This reply should be clearly marked as a j

' Reply to a Notice of Violation" and should include for each violation:

(1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results i achieved, (3) the corrective steps that u111 be taken to avoid further violations, and (4) the date when full compliance will be achieved. If an )

4 adequate reply is not received within the time specified in this Notice, an order or a demand for information say be issued as to why the license should I

not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time. l

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Dated at kisle, Illinois I this 796 day of November 1994 O

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UNITED STATES NUCLEAR REGULATORY COMMISSION REGION III Report No. 030-16055/94004(DRSS)

License No. 34-19089-01 Priority I Category B Docket No. 030-16055 Licensee: Advanced Medical Systems, Inc. (AMS) 1020 London Road Cleveland, OH 44110 Inspection At: Advanced Medical Systems, Inc. (AMS) 1020 London Road i' Cleveland, OH 44110

- Site Inspection Conducted: October 11-12, 1994 Inspectors: beus*> - b-Wayne $lawinski, Senior

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Date' Radiation Spec alist, Region III WD rt Shewmaker, Senior Structural i,1u/As-Dath /

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ngineer, Office of Nuclear Material Safety I and Safe uards i Reviewed By:

' d-# B[g!N John Madera, Chief Datfe Ma rials Licensing Section, Region III Approved By: 4 79 M n A. Grobe, Chief Date' /

clear Materials Inspection Section 2 Region III -

Inspection Summary Inspection on October 11-12. 1994 (Report No. 030-16055/94004(DRSS))

Areas Inspected: Routine, announced inspection to evaluate certain limited aspects of the licensee's NRC-licensed program including a review of: (1) the implementation of the facility Radiological Contingency Plan; (2) information relative to assessing the WHUT room's structural integrity; and (3) recent facility water usage practices. One of the inspectors also met with representatives from the Cleveland Fire Department at the London. Road facility to discuss.its radiological hazards and the licensee's Radiological Contingency Plan.

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Results: Three violations of Radiological Contingency Plan (RCP) requirements were identified as described in section 4(b). In addition, several RCP related concerns were notwi including licensee personnel familiarity with the plan and a lack of management oversight in the plan's implementation.

Similarly, the licensee has not adequately interfaced with local emergency ,

response officials to ensure they are fully cognizant of the facility's hazards and its RCP. The inspection also disclosed that a WHUT room surveillance and radiation survey program has not been implemented in accordance with licensee commitments.

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t DETAILS ,

1. Persons Contacted licensee Reoresentatives

+ David Cesar, Treasurer, AMS i

• Robert Meschter, Radiation Safety Officer, AMS

!. Vincent Rocco, Technician, ANS

! ++Seymour Stein, Ph.D., President, AMS

++ Edward Svigel, Engineering Manager, AMS l William Muniak, Attorney, Arter & Hadden Cleveland Fire Department Representatives i Rginald Keith, Lieutenant, Pre-Plan Office l William Little, Captain, Pre-Plan Office

• Thomas Root, Captain & Fire Marshal-T The inspectors also met with other members of the Cleveland Fire Department during a meeting with Captain Root at the AMS facility on October 12, 1994.

• Denotes presence at site exit meeting on October 12, 1994. .

+ Denotes participation in the exit meeting teleconference on

. October 21, 1994.

++ Denotes telephone contacts only.

2. Purpose and Scope of Inspection This was a limited scope safety inspection conducted primarily to gather information and visually examine accessible areas of the London Road facility relative to assessing the Waste Holdup Tank (WHUT) room's structural integrity. Also reviewed, in part, was the implementation of the licensee's RCP for the London Road facility, including discussions with the Cleveland Fire Department regarding the licensee's plan and related matters. Additionally, the inspectors reviewed the London Road ,

facility's recent water usage and sanitary sewer discharge practices.

3. WHUT Room Structural Assessment As noted above, the primary purpose of this inspection was to assess the structural integrity of the London Road facility's WHUT room. The WHUT room is a poured concrete structure located in the basement of the  ;

facility beneath the hot cell, housing two liquid radwaste holdup tanks. '

The holdup tanks contain unknown quantities of cobalt-60 contaminated liquids and/or sediment. The WHUT room was isolated by the licensee 3 .

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beginning in 1988 in lieu of its decontamination, as described in the licensee's letter to the NRC dated February 8,1988. The room's l temporary isolation was approved by the NRC in a letter dated

.0ctober 20, 1988. ,

To assess the structural integrity of the WHUT room, the inspectors reviewed information relative to the room's design and construction, and visually examined accessible exterior portions of the room and adjacent ,

structures. Original facility blueprints and construction photographs i taken in approximately 1960 were also reviewed. Personnel entry into the WHUT room is currently prohibited due to the room's existing radiological condition, j

The NRC's arsessment of the WHUT room's integrity is continuing. The licensee will be provided the results of the assessment when they become available.

Licensee letter dated February 8,1988 describes the remedial actions for the WHUT room, including a description of the isolation methods proposed for the room and plans for monitoring the area after its isolation. Section H of the attachment to the February 8,1988 letter, entitled " Maintenance of the Isolated State," describes a monitoring and surveillance program to ensure the room remains properly isolated. The monitoring program is to include weekly radiological surveys of the accessible exterior surfaces of the room. - Specifically, the monitoring program is to consist of radiation level measurements and smears taken -

in reproducible locations on the exterior walls, and smears of all

- accessible penetration blocks. Section H further states that procedures addressing the room, its status and other specified information will be included in facility ISP procedures.

The inspection disclosed, however, that the commitments in Section H of the. attachment to the February 8, 1988 letter have not been met. For example, as of October 12, 1994, ISP procedures do not address methods for verifying the integrity of WHUT room isolation. In addition, a radiation level measurement and contamination smear survey program has not been implemented for the exterior walls of the WHUT room. Although no deliberate changes to the WHUT room and its contents have been made since the rooms isolation in 1988/89, a monitoring and surveillance program is necessary to ensure its continued proper isolation.

Subsequent to the inspection, the licensee performed radiation measurements on exterior portions of the WHUT room's walls. No evidence of WHUT room integrity problems were identified.

No violation of regulatory requirements was identified; however, one concern was noted.

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4. Radiological Continaency Plan (RCP)

a. Backaround Information In 1991, the licensee developed a RCP for its London Road Cleveland, Ohio facility, pursuant to 10 CFR 30.32(1). A RCP dated October 5,1991, was submitted by the licensee for NRC review, reportedly after. incorporating comments / suggestions from the Cleveland Fire Department, Police Department and Emergency i Medical Services Agency. The RCP outlines licensee and certain offsite response organization responsibilities and describes its i emergency plan for responding to fire, explosion or other events j that could result in a release of radioactive material.

I The RCP developed by the licensee was reviewed and approved by the i NRC and incorporated into License No. 34-19089-01 via Amendment l No. 25, dated July 30, 1992. License Condition No. 18 currently

requires that the licensee maintain and execute the response l measures of their Emergency Plan dated October 25, 1991*and i revised January 1992, May 27, 1992 and April 26, 1993.

} b. Plan Imolementation Portions of the RCPs implementation were evaluated during this inspection. Additionally, the plan and the London Road facility's l radiological hazards were discussed.with Cleveland Fire Department u i representatives during a meeting at the facility on October 12, l

1994.

J j The inspection showed that the RCP has not been implemented as

' required. The inspection also disclosed licensee management involvement and oversight of the plan s implementation to be weak, j particularly within the last year since the licensee's Regulatory

Affairs Director has been on leave. Problems have been compounded i

by continued turnover in radiation safety officer staff. The

inspection identified several RCP implementation violations and related concerns, as described below.

Item 7.3 of the "Onsite Radiological Contingency Plan For The Cleveland, Ohio Facility," revised May 27, 1992 and April 26, 1993, requires that the li:ensee conduct a' full scale biennial exercise with offsite emergency response personnel. As described above, the RCP was incorporated into License No. 34-19089-01 on July 30,1992.,

As of October 12, 1994, no full scale exercise involving offsite emergency response personnel has been conducted by the licensee.

Failure to conduct a full scale exercise is a violation of License Condition 18 which references the RCP.

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In a letter to the NRC dated September 22, 1993, the licensee infomed the Commission of its intent to conduct the reouf red exercise.in December 1993. However, according to licensee

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representatives, the exercise was not conducted.

Item 7.5 of the RCP requires that the licensee conduct an annual audit to review the emergency response program, and emergency plan procedures, training, equipment and supplies.

As of October 12, 1994, no licensee audits of the emergency response program, emergency plan procedures or training have been conducted.

Items 6.3 and 6.4 of the RCP list the licensee's emergency response equipment and supplies located in the fire pumphouse located approximately 300 feet west of the London Road facility.

Item 7.6 of the RCP requires that fire pumphouse emergency equipment and supplies be inventoried and checked quarterly, and that inoperable or missing equipment be repaired / replaced as soon as possible. -

During the inspection on October 12, 1994, certain emergency response supplies required to be located in the fire pumphouse were not available. Specifically,' supplies absent included London Road facility building-keys, a current listing of emergency response personnel.and ccrresponding telephone numbers, and $3.00 .

in quarters.

In addition to the violations described above, other concerns related to RCP implementation were identified. These concerns are described below, l l

(1) Appendix A of tta RCP includes a list of licensee " Emergency l Contact Personnel." The list was revised in Septe'nber 1994  ;

and includes the name of the RSO, Engineering Manager and Director of Regulatory Affairs. Inspector conversation with i the Engineering Manager revealed only a cursory familiarity '

with the RCP. Also, the revised emergency contact list failed to include the correct telephone number for the NRC Operations Center and Region III office.

(2) The Regulatory Affairs Director has several responsibilities in the RCPs implementation. However, the director has been on leave for over one year and no other individual (s) has fulfilled the director's RCP responsibilities.

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5 O (3) An October 12, 1994 meeting with Cleveland Fire Department representatives revealed that the licensee has not interfaced sufficiently with fire department personnel, to develop a thorough familiarity with the RCP and the licensee's facility. Subsequent to the inspection, the NRC learned that the fire department has classified the AMS facility as an Extremely Hazardous Substances (EHS) facility. According to the Cleveland Fire Department, EHS facilities warrant an emergency pre-plan, detailing fire department procedures and planned actions for responding to facility emergencies.

As of November 18, 1994, the fire department's first response units have toured the facility and been instructed by the licensee in its radiological hazards. The department's hazardous materials unit plans to tour the facility in the near future. The fire department anticipates development of its emergency pre-plan by the end of 1994.

Three violations of regulatory requirements and several concerns were identified.

5. Water Usaae and Disposal Practices

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The inspectors reviewed City of Cleveland water billing records for the London Road facility and discussed recent water usage practices with the ..

j licensee.

I According to the current AMS facility RSO, no liquid radwaste has been -

j discharged into the sanitary sewer system since his employment initiated in July 1994. The RSO further stated that no liquid radwaste has been generated, other than on_ August 22, 1994, when an employee showered to.

i remove a small quar.tity' of facial contamination. The facial i contamination occurred during the decontamination of lead blankets in the isotope shop. Approximately 2-3 gallons of water was reportedly used by the employee while showering in one of the facility's designated decontamination showers. The decontamination showers drain to a 200-gallon plastic tank located in the front basement of the facility. The liquid generated during the shower remained in the tank and has since evaporated.

The licensee receives water billing and consumption information on a quarterly basis. Quarterly records for the London Road facility were reviewed by the inspectors for the period July 1992 through June 1994.

The records show, with one exception, quarterly water usage to range from about 45,000 ft* during the fourth quarter of 1992 to 83,000 ft' 7 .

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, I for the first quarter of 1994. This equates to a volume range of 3740 i

- to 6900 gallons per day. Theexceptionoccurredduringthesecond quarter of 1993, when only 6000 ft (500 gallons / day) was used. Billing ,

records show total water usage for the 12-month period July 1993 through  !

June 1994, to be nearly twice that used during a corresponding peHod in l 1992-1993. The licensee attributes the increased usage in mid-1993 to mid-1994 to escalating plumbing problems in the facility. The reason i for the relatively small volume of water used during the second quarter '

of 1993 is unknown.

According to the licensee, facility water usage is primarily limited to general use of toilets, sinks and urinals for sanitary and consumption

> purposes. Since the facility is normally occupied by only two or three individuals for a single shift, typical daily water usage is expected to .'

be only about 100-200 gallons. As noted above, the licensee's water usage over the last two years has been significantly greater than expected. According to the licensee, plumbing problems have plagued the facility for several years and have been allowed to continue unrepaired.

According to the licensee, the plumbing problems were continuous, l however, their severity could fluctuate day-to-day. The problems have worsened over the last 6-10 months. NRC inspectors have been aware of i some of these plumbing problems for over one year, including a continually flushing toilet and leaking urinal flush mechanism in the  ;

men's lavatory. l During an NRC inspector London Road facility site visit on July 7, 1994, .

the inspector observed unexpectedly large quantities of water discharging into the sewer system, when viewed from the manhole area  !

just outside the facility. The July 1994 discharges were, at the time,  !

attributed by the licensee to the aforementioned plumbing problems. j This explanation was plausible since a stuck flush mechanism on the men's toilet was known to be a continuing problem.

A standard toilet continuously flushing at about 50% of its normal i capacity can use roughly three gallons of water per minute or 4300 gallons per day. Therefore, the London Road facility's unusually large water usage since 1992 appears to correlate with the plumbing problems.

On or about September 29, 1994 and continuing the week of October 3, 1994, a contractor repaired the plumbing problems known to exist at the facility. The work included installation of two new urinals to existing flush valves, and repair of a toilet flush valve. As a result of the repairs, facility water usage beginning the fourth quarter of 1994 should be significantly reduced. During the inspection on October 12, 1994, the inspectors removed the manhole cover where discharges to the sanitary sewer system exit the London Road facility, and verified that discharges had ceased. The inspectors also observed the new plumbing fixtures and plumbing contractors billing record.  !

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6. Exit Heetino The inspectors met with the licensee's RSO at the conclusion of the site inspection on October 12, 1994, and summarized the scope and findings of the inspection. On October 21, 1994, a teleconference was conducted between Mr. Roy Caniano and other NRC Region III staff and Mr. David Cesar of AMS. The inspection findings, NRCs planned enforcement action and the licensees corrective action options were discussed during the teleconference.

The licensee did not indicate that any of the information reviewed {

during the inspection was considered proprietary.

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