ML20045D009
| ML20045D009 | |
| Person / Time | |
|---|---|
| Issue date: | 08/04/1989 |
| From: | Bolt B NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Joseph Kelly IOWA, STATE OF |
| Shared Package | |
| ML20042C965 | List: |
| References | |
| NUDOCS 9306250229 | |
| Download: ML20045D009 (11) | |
Text
.
QUESTION 33 11NITED STATES
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NUCLEAR REGULATORY COMMisslON 9
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S atosos m t,
f n.anocevetrmean cLtw totvw. LL Nois.our August 4,1939 lewa Department of Public Health All N: John R. Kelly, Director r
Division cf Disease Prevention Lucas State Office Building Des Moines, IA 50319-0075
Dear Mr. Kelly:
As discussed in our meeting on June 14, 1989, enclosed is the report of my findings during the recent visit to your State's Radiation Control Program fer agreement materials. Your staff will be provided with reference materials and other information requested under separate cover. Please contact ne if you have questions or require further clarification on any of the findings.
I appreciate the courtesy and cooperation extended to me by your si aff during the visit.
Mr. Davis and I are also appreciative of the opportuni1y to discuss with you our respective regulatory roles and the evaluation of the current status of the State's program for reculation of agreement materials.
It was especially pleasing to hear your comments supporting the Bureau ofIRadiological Health and the necessity for continuous cooperation between the NRC and the State. We lock forward to a long and fruitful relationship with yc u as partners under the Agreement States Program.
Sincerely
-0 O' B. J. Holt States Agreement Program Ofiicer
Enclosure:
As stated cc w/cnclosure:
V. Miller, SLI1P 5
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10WA REVIEW VISIT DETAILS 1.
Persons Contacted Iowa Department of Public Health John R. Kelly, Director, Division of Disease Prevention Don Flater, Chief, Bureau of Radiation Control Bruce Hokel, Supervisor, Radioactive Materials Program Charlene Rogers Environmental Specialist II. General A review visit was conducted June 12-14, 1989 at the Iowa Depa rtment of Public Health in Des Moines, Iowa. The purpose of the visit w as to assess the current status of the State's program for regulation of ag reement materials and to assist the radiation control program (RCP) st aff in its preparatian for a full review scheduled for the spring of 1990.
In addition to discussions with program management and staff, the visit included evaluations of the RCP's administrative procedures, (mergency procedures for responding to radiological incidents, incident file, regulations, and selected license and compliance files. The r esults were discussed with Messrs. Kelly, Flater and Hokel in an exi1 meeting on June 14.
Mr. A. Bert Davis, Regional Administrator, NRC Re gion Ill participated in the exit meeting.
III. Status of Findings During Previous Program Review Conducted May'24-27, 13BH for the Period June 6, 1986 to May 27,1988 The previous program review indicated that the Iowa radiation control program was adequate to protect the public health and safety a nd was l
rnmpatible with that of the NRC. Two comments and recommendai ions were made, however, on administrative and technical aspects of the program.
These are summarized below:
t Staffing Level: The radiation control program was found'to b4 l
understaTTed. During the period from June 1986 to May 1986,i he l
professional staffing level ~ decreased from apprnvimately.1.81 o 1.2 FTE.
l The NRC-staff recommended that at least one full-tine profess < onal be j
added to the program to work in both licensing and inspection areas.
j The Stata responded by budgeting funds fnr nne professional pi sition
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and for one' secretarial position. -The RCP staff is currently interviewing prospective candidates for an Environmental Specialist II pos-tion. This-individual will work full-time in the agreement materials prog ram. The staff hopes to extend an offer to the successful. candidate by August 1, 1989. A full-time secretary for the Bureau of Radiation Control was hired on June 9, 1989. 'Approximately 50% of her time will ha devnted f is in to the agreement materials program.
In addition, the RCP sta o the process of training an Environmental Specialist I to hand e licensing and inspection cacework of a less complicated nature.
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inspection Procedures: A review of selected compliance files and accompaniments during two facility inspections indicated the n 2ed for interviews of workers and ancillary staff.
The NRC staff reca amended
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that inspection forms be revised to include worker interviews.
The RCP staff agreed in a letter dated September 26, 1988 to incorporate this change. According to Mr. Hokel, interviews of workers and ancillary l
personnel during inspections are being conducted whenever possible.
i However, at the time of the review visit, only the inspection form for medical facilities had been revised to include this element.
IV.
Current findings and Recommendations A.
Status and Compatibility of Regulations:
1.
The State will need to adopt the following three regJlations deemed by the NRC to be matters of compatibility:
a.
Bankruptcy notification, due February, 1990.
b.
NAVLAP certification of dosimetry processors, d Je Februa ry. 1991.
General requirements for decommissioning, due J fly, 1991.
c.
2.
In order to maintain a high degree of uniformity wit i NRC regulations, the State may wish to consider adopting the following two additional regulations:
e.
Exemption for use of aerosols, NRC effective da te March, 1087.
b.
Revision for medical use of radioactive materia s, NRC ef fective dato April 1987.
(NOTE:
The regulation invo'lving bankruptcy notification vill need to be adopted prior to the 1990 program review.)
B.
Quality of Emergency Planning:
The State has developed an emergency plan for non-power reactor radiological incidents.
This plan is an augnentation to he Iowa Emergency Multi-Hazard Plan.
It identifies the approprie.e State agencies to be notified and their responsibilities, and provides guidance on response actions. The Bureau of Radiological Health has also developcc an in-house incident response plan and a clxt kl is t for first responders to an incident.
The following recomnendations were made relative to the State's overall emergency plann-ng activities:
1.
Conduct periodic drills to test emergency response p1 ocedures.
The RCP may wish to contact the Disaster Services Dii ision about coordinating the drills,
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2.
Revise the In-house incident Response Plan (Administrative Precedure 89-0001) to include appropriate NRC phone numbers.
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Revise the Incident Report Form to indicate the status of an incident--whether the incident is closed or whether
- here are still concerns to be resolved (open status).
3.
Distribute the checklist for first responders to an ncident to appropriate personnel at the University of Iowa Hygienic Lab, Iowa State University. Iowa Department of Transportanion. and to other groups who may be called on by the RCP to assist in emergency response.
The following additional recommendation was made relative to the RCP's incident file:
Organize the incident file, starting from either the begi1 ning of the Agreement State Program (January 1986) or the beginning of the current program review period (May 14R8). The RCP ma; wish to categorize the file according to incidents, allegation misadministrations, etc.
Include a sungnary fonn (e.g. Incident Panort Record) for each occurrence and the report if appl' cable.
If the report is filed in another location, this should be indicated on the sunnary form.
C.
Administrative Procedures:
The kCp has developed written procedures for addressing certain acministrative functions such as tracking license applica
- ions, collecting fees, etc.
Now that the RCP staff 1s expandin!
additional procedures need to be developed and/or documen1 ed to insure consistency in training of new personnel and unifoi mity of regulatory practices by the entire staff.
These procet ures include the following:
1.
Responding to requests, complaints, and allegations < rom licentcca and the general public.
2.
Comnunicating with the media.
3.
Conflict of interest policy for RCP employees.
4 Interpretations of State reculations.
5.
File maintenance.
D.
Technical Quality of Licensing Actions:
Nine license files were reviewed during the interim review with an emphasis on requests for license terminaticn.
(See Enclosure 1 for listing.) The reviews indicated that the RCP needs to deselop procedures for reviewing requests for license termination.
The procedur es should contain the criterion the RCP will use to perform j
a tennination inspection and guidelines the reviewers will use for 3
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evaluating requests from licensees authorized to use sealt d and/or unsealed material.
As a minimum, license reviewers shoul:
consider the following prior to terminating a license:
1.
Where unsealed material is authorized, the licensee ! hould submit i
radiation survey method (s) and measurements to show ' hat the facility can be released for unrestricted use.
I 2.
For transfer of radioactive material, the license rei iewer must verify that the intended recipient is authorized to i eceive the material.
3.
The licensee's statements must clearly indicate that all radioactive material has been removed from all locat' ons listed on the license as authorized places of use.
4 A termination inspection may need to be conducted, pa rticularly if unsealed material is authorized.
Licenses authorizing use of plutonium in pacemakers shoul<
not be terminated if the pacemakers are still implanted in pa1 1ents.
The RCP should not send out the standard renewal notice tc these licensees.
Bruce Hotel was given a sample renewal notice used by the NRC reminding pacemaker licensees of their long-tenn c bligation.
The pacemaker license issued to Mercy Hospital Medical Cer ter in Des Moines which was terminated in April 1988 needs to be reissued.
The RCP was commended on its turn-around time for licensir g requests.
At the time of the review visit there were no overdue lice nsing actinns.
All requests-applications for new licenseos, ar* ndments and renewals-had been in-house less tnan 30 days.
f Iiconsing Procedures:
The RCP needs to develop technical procedures addressing certain licensing functions. Again, this becomes particularly ict ortant since the RCP staff is expanding. Procedures need to be ceveloped for:
1.
Performing license reviews (preparations, guides, checklists, etc.).
1 2.
Conducting pre-licensing visits.
3.
Handling deficient applications.
4.
Reviewing requests for license termination.
5.
Supervisory review of licensing action.
It was also recommended that the Supervisor of the Radioac Live Materials Program develop a licensing notebook (s) for eact license type, e.g. medical, industrial radiography, academic, well logging, portable gauges, etc.
The notebook should contain inforue Lion m
pertinent to the review of applications for a given license type, 4
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including the regulatery guide, standard review plan, cht:k li st, model license and sarrple a nendments, information notices, bulletins, internal policies, etc. The notebook (s) should be distributed to all reviewers.
In June 1989, the RCP issued ERH Bulletin 89-06:
Policy Statement-Eyemption of Sealed Sources of Radium-226 and Thorium-228 Less Than 0.1 Microcurie.
It was recommended that this tulletin be revised to delete any reference to thorium-228. Thorium is source material regulated by the State under an agreement entercd into by the State and the NRC pursuant to the provisions of the Atomic Energy Act, as amended. The NRC does not have an equivalent standard in 10 CFR Part 40 exempting thorium sealed sources of low activity.
The RCP staff was informed that implementation of this pc licy for thorium-228 will cause significant concerns regardinc the compatibility cf the State's regulatory program relative to that of the NRC.
F.
Status of Inspection Program:
At the time of the review visit. approximately 16% of the State's licenses were due for inspecticn. Approximately 3% were overdue by more than 50% of their respective inspection frequency.
Although there did nnt appear to be a significant inspection backlog. it was recommended that inspections be given a higher priority.
The RCP staff was informed that the NRC recognizes the dilemma ary regulatory agonry faces in trying to implement its mission with limited personnel resources. However, the inspection of licensed operatior s is essential to assuring that activities are being conductec in arccrriance with regulatory requirements and good safety tractices.
This has a direct bearing on the goal of any radiation ccntrol
- program, i.e., protection of the public health and safet)
G.
Inspection Precedures:
T h r. RCP needs to document precedures for:
1.
Assigning inspections.
2.
Conducting inspectior,s.
4 3.
Itcuing notices of violations and findings of healtt and safety problems.
4.
Tracking enforcement correcpondence.
5.
Supervisory review of inspection reports.
If NRC procedures are used, they should be assembled in a n inspection manual and supplemented by in-house policy meroranda, bulletins, etc.
This will fccilitate training of new personnel and help to insure consistency of staff performance.
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Inspection Heports:
Four files were reviewed to determine if inspection repor1 s adequately documented tne results of the inspections and substantiat<d all items of noncompliance.
(See Enclosure 2 for listing.) Some of the reports appeared to have been hastily written.
In general, there was no documentation of interviews with workers and anc111ary pei sonnel, and no adequate documentation of the results of confirmatory r.casurements.
The staff needs to devote more effort and time to the prel aration of inspection reports.
There should be clear docunentat1on ( t entrance /
exit discussions, follow-up on previous citations of violations, worker interviews, confirmatory measurements, observations of operations, items of noncompl1ance, and other concerns anc recommendations.
1.
Confinnatory Measurements:
Certain RCP survey instrumentation used for conducting cor firmatory measurements at licensee facilities is not being calibrate d at the required frequency. The reason appears to be lack of sta1 f resources and time. The RCP may need to make other arrangements for instrument calibration service to insure that instruments are calibreted at intervals not greater than that required for licensees be ng inspected.
The RCP was infunned thet Illinois Depdrtment of Nucleer l afety operates a regional calibration facility. The charge to !
tate and local governments for calibration service is minimal.
V.
State init1atives
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The RCP is considering a radiography testing program and ney er ter into the rulemaking process for such a program as early as January J 990.
The program will be implemented in conjunction with the CRCPD.
Within the next two years, the RCP plans to develop and implemt nt a certification program for nuclear medicine and radiation therary technningists.
The State's budget for FY90 includes REACTS training and other relevant radiation safety-related courses sponsored by Oak Ridge Associa ted Universities for the RCP staff.
The Iowa Departroent of Natural Resources sent a questionnaire 10 all lowa licensees who generate radioactive waste. Only four licensees indicated that t. hey will have difficulty storing waste during the period 1993-1997.
These four were small research and development laboratories.
The State may establish an MOU with Dak Ridge Associated Univer sities for limited sample analyses.
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Inspection Reports:
Four files were rev1ewed to determine if inspection repor1 s adequately
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documented the results of the inspections and substantiattd all items of noncompliance.
(See Enclosure 2 for listing.) Some 01 the reports appeared to have been hastily written.
In general, there was no documentation of interviews with workers and anc111ary pel sonnel, and no adequate documentation of the results of confirmatory r,easurements.
The staff needs to devote more effort and time to the prel aration of inspection reports.
There should be clear documentation ct entrance /
exit discussions, follow-up on previous citations of violi
- tions, worker interviews, confirmatory measurements, observ,ations of operations, items of noncompliance, and other concerns anc recommendations.
1.
Confinnatory Measurements:
Certain RCP survey instrunentation used '
conducting cor firmatory measurements at licensee facilities is
..vt being calibrated at the required frequency.
The reason appears to be lack of sta1 f resources and time. The RCP may need to make other arrangements for instrument calibration service to insure that instruments are calibri ted at intervals not greater than that required for licensees be~ng inspected.
The RCP was intonned that Illinoi; Department of Nucleer l afety cperates a regional calibration facility. The charge to S tate and local governments for calibration service is minimal.
V.
State Initiatives The RCP is considering a radiography testi g program and ney er ter into the rulemaking process for such a program ds early as January 1990. The program will be implemented in conjunction with the CRCPD.
Within the next two years, the RCP plans to develop and impleme nt a certification program for nuclear medicine and radiation therat y forhnningists.
The State's budget for FY90 includes REACTS training and other relevant radiation safety-related courses sponsored by Oak Ridge Associatod Universities for the RCP staf f.
T he Iowa Departrnont of Na tural Resources sent a questionnaire to all lowa licensees who generate radioactive waste. Only four licensees indicated that they will have difficulty storing waste during the period 1993-1997.
These four were small research and covelopment laboratories.
The State may establish an MOU with Dak Ridge Associated Univer sities for limited sample analyses, 80*d COICrOslCC l6 Cd HD94 ?ll3Gd 30 id31 01 1033 IC:90 c661-02.'Sil
VI.
Conclusion This review visit identified problems or poter,tial problems ir several program areas.
1hese will need to be addressed and/or resolved prior to the next full program review in order to avoid a finding that the Icwa program for regulation of agreement materials is not adequate to protect public health and safety and/or is not compatible with 51milar programs of the NRC. The problems appear to have accumulated as a result of a shortage of personnel, particularly technical personnel, devoted to the agreement materials program.
The State is taking positive action to overcome the staffing shortage. The State may find, hcwever, that the problems identified during this visit may be temporarily compcunded as a result of having to expend additional statt effort and time in tne training of new personnel. The NRC should provide technical assistance and support to the State as needed. The State should make every effort to hire personnel experienced in health physics and in the regulatory aspects cf radioactive material litersing and inspection.
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ENCLOSURE 1 LISTING OF LICENSE FILES REVIEWED 1.
Licensee: Davenport Medical Center Address: Davenport, Iowa License No.: 0118-1-82-MI License Type: Group Medical License Action:
Renewal, issued 1/27/89 Reviewer: Bruce Hokel 2.
Licensee:
Scott County Health Department Address: Davenport, Iowa License No.-
0139-1-82-PG License Type:
X-Ray Fluorescence Analyzer License Action: Amendment, issued S/19/89 Reviewer:
Charlene Rogers 3.
Licensee: Geotechnical Services Address:
Ames, Iowa License No.:
0084-1-85-PG L1 cense Type: Moisture-Density Gauge l
License Action: Amendment, issued 3/24/89 Reviewer:
Bruce Hokel 4
Licensee:
1.I.W. Engineers end Surveyors, P.C.
1 Address: Dubuque, Icwa i
License No.:
0168-01-31-PG License Type:
Mnisture-Density Gauge License Action: Renewal, issued 5/19/89 Reviewer: Bruce Hokel i
5.
Licensee: Marshalltown Community College Acdress: Marshalltown, Iowa License No.:
SNM-969 License Type:
PuBe Source
[
License Action: Termination, 1ssued 11/12/86 6.
Licensee: Mercy Hospital Medical Center Address:
Des Moines, Iowa l
License No.:
SNM-1793 License Type:
Pacemaker License Action:
Termination, issued 4/18/88 i
7.
Licensee: Norland Research Address: Cedar Rapids, Iowa l
License No.:
License Type:
Research & Development License Action: Termination, issued 12/31/86 j
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) : Listing of License Files Reviewed (continued) i I
8.
Licensee: Cepex Midwest Address:
Fort Madison, Iowa
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License No.: 0070-1-56 License Type:
Fixed Gauge License Action:
Tennination, issued 5/11/88 9.
Licensee:
Pathology Laboratory, P.C.
Address: Des Moines Iowa License No.:
License Type:
Invitro Testing License Action: Tennination. issued 6/24/88 t
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ENCLOSURE 2 i
LISTING OF COMPLIANCE FILES REVIEWED 1.
Licensee: Davenport Medical Center Address: Davenport, Iowa License No.:
License Type:
Group Hedical Inspection Date:
1/17/89 Inspection Type: Routine, Unannounced Inspector:
Bruce Hokel 2.
Licensee:
Hydrostorage, Inc.
Address: Ops Mninos, inwa License No..
0055-1-77-IR1 License Type:
Industrial Radiography Inspect. inn Date:
11/29/R8 Inspection Type:
Routine, Unannounced 1
Inspector: Bruce Hokel 3.
Licensee:
Clarinda Municipal Hospital Address: Clarinda, Iowa Licence No.
14-18869-01 License Type:
Group Medical Inspection Date:
4/21/89 Inspection Typa:
Routine, Unannounced Inspector:
Bruce Hokel 4.
Licentaa:
.lannia Edmondson Hospital B
Address:
Council Bluffs, Icwa e
license No.-
0085-1-78-M1 License Type:
Group Medical Inspection Date: 4/19/89 Inspection Type:
Routine, Unannounced Inspector: Bruce Hokel 1
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QllESTION 35.
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h UNITED STATES
.I NUCLEAR REGULATORY COMM!SSION k
WASHIN GToN. D.C. 23Eli6
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October 22, 1992 The Honorable Terry Branstad Governor of Iowa State Capitol Des Moines, Iowa 50319
Dear Governor Branstad:
This letter refers to the discussion Mr. A. Bert Davis, Region III Administrator, Ms. B. J. Holt, Chief, Nuclear Materials Safety Section 1, Mr. James Lynch, State Agreements Officer and Mr. Carlton Kammerer, Director, Office of State Programs, held with Mr. Christopher G. Atchison, Director, Iowa Department of Public Health, Mr. Jack Kelly, Director, Division of Health Protection, Mr. Donald Flater, Chief, Bureau of Environmental Health and Mr. David Fries, Director, Division of Administration and Planning, on September 4, 1992. As a result of our follow-up review of the State's radiation control program, our view is that the Iowa program has serious management and programmatic deficiencies which, unless addressed expeditiously, could put your 274b Agreement in jeopardy. The NRC will i
provide the State with short-term assistance as described in more detail in this letter, to assist in your prompt correction of the program deficiencies.
In 1985, you and the NRC Chairman signed an Agreement pursuant to Section 274b of the Atomic Energy Act, whereby the State of Iowa assumed the regulatory authority for byproduct material (as defined in Section lle.(1) of the Atomic Energy Act), source and special nuclear material in quantities not sufficient to form a critical mass. The Agreement provided that the State will use its best efforts to maintain continuing compatibility with the NRC's program. The past two reviews, in July 1990 and October 1991, resulted in the withholding of a finding of adequacy and compatibility due to significant programmatic deficiencies. The current review found the radioactive materials program continuing to decline to the point where immediate measures need to be taken to reestablish the State's ability to conduct basic materials inspection and licensing functions. We believe that immediate, decisive actions must be taken by the State of Iowa to restore the radioactive materials program to a level of adequacy that will provide protection of public health and safety.
In order for the State to continue with the 274b program, strong management involvement and control must be instituted and the staffing shortage, which has plagued the program for years, must be alleviated. These elements, quality management and qualified staffing, are essential to bring the program back to an adequate and compatible standing and to provide a lona-term i
solution to program deficiencies. We would appreciate receiving from you, within thirty days of this letter, an action plan for responding to the i
recommendations in the enclosure.
,Mo^LToI o
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The Honorable Terry Branstad 2
l Your staff stated during the September 4, 1992 meeting that Iowa was making an j
effort to increase management involvement and control over the materials program by a restructuring which would allow managers increased interaction time with the radioactive materials program. The NRC believes that active and consistent management of the materials program is essential to improve and to add stability to Iowa's program. Management must be involved on a daily basis in program oversight, personnel development and quality control.
Mr. David Roederer of your staff informed me that two technical staff positions were released for recruitment and hiring for the radioactive materials program. Mr. Flater has also informed us that negotiations are underway with a consultant to provide inspection training, to write procedures and to develop inspection and licensing tracking systems. The NRC will provide short-term assistance to the State of Iowa to achieve our common goal of public health and safety by providing licensing and inspection training and technical assistance. Region III license reviewers and inspectors will provide training and assistance to your staff in the Des Moines office, the Region III office and at your licensee facilities. Mr. Lynch, the Regional State Agreements Officer, will work out the details of this effort with Mr. Atchison in the near future.
Enclosure I contains an explanation of our policies and practices for reviewing Agreement State programs. is a summary of our assessments and comments which were discussed with your staff at the conclusion of the review. As stated earlier, we request specific responses from the State on the current review comments and recommendations in Enclosure 2 and in this letter within thirty days of this letter date. As discussed in this summary, we are concerned that several commitments made in response to our October 1991 review were not factual. Specifically, the January 6,1992 letter to Mr. Kammerer which was signed by Mr. Flater and Mr. Hokel stated:
(1) that certain information notices had been sent to licensees when they had not; (2) that licensing audit checklists would be used in casework audits henceforth and they were not; and (3) that licensing notebooks had been developed when they had not. This information was partially addressed in Mr. Flater's letter of September 16, 1992. These misrepresentations question the credibility and the effectiveness of management oversight of the program.
Iowa's upper management should address this concern in the resporse to this letter.
When received, we will provide Mr. Atchison with our thoughts on the action plan, and in any event, we will review the progress of the Iowa program in three months to determine if necessary progress has been made to justify continuation of the 274b Agreement.
In accordance with NRC practice, I am also enclosing a copy of this letter for placement in the State's Public Document Room or otherwise to be made available for public review.
1 Y
The Honorable Terry Branstad 3
(
I appreciate the courtesy and cooperation extended the NRC staff during the l
review.
I am looking forward to your response.
Sincerely,
/
L6 I
>es M.
a or ecutive D rector for Operations
Enclosures:
As stated l
cc w/encis-Christopher G. Atchison, Director Iowa Department of Public Health j
John R. Kelly, Director i
Division of Health Protection i
Donald A. Flater, Chief Bureau of Environmental Health Carlton Kammerer, Director Office of State Programs A. Bert Davis, Regional Administrator NRC Region III
(
State Public Document Room NRC Public Document Room State Liaison Officer i
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ADolication of
- Guidelines for NRC Review
~
of Aareement State Radiation Control Procrams" The
- Guidelines for NRC Review of Agreement State Radiation Control Programs,"
were published in the Federal Egoister on May 28, 1992, as an NRC Policy t
Statement. The Guidelines provide 30 indicators for evaluating Agreement State program areas. Guidance as to their relative importance to an Agreement State program is provided by categorizing the indicators into two categories.
Category I indicators address program functions which directly relate to the State's ability to protect the public health and safety.
If significant problems exist in several Category I indicator areas, then the need for improvements may be critical.
Category II indicators address program functions which provide essential technical and administrative support for the primary program functions. Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or niore of the principal program areas, i.e., those that fall under Category I indicators. Category II indicators frequently can be used to identify underlying problems that are causing, or contributing to, difficulties in Category I indicators.
It is the NRC's intention to use these categories in the following manner.
In reporting findings to State management, the NRC will indicate the category of each comment made.
If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety and is compatible with the NRC's program.
If one or more significant Category I comments are provided, the State will be notified that the program deficiencies may seriously affect the State's ability to protect the public health and safety and that the need of improvement in particular program areas is critical.
If, following receipt and evaluation, the State's response appears satisfactory in addressing the significant Category I comments, the staff may offer findings of adequacy and compatibility as appropriate or defer such offering until the State's actions are examined and their effectiveness confirmed in a subsequent review.
If additional information is needed to evaluate the State's actions, the staff may request the information through follow-up correspondence or perform a follow-up or special, limited review.
NRC staff may hold a special meeting with appropriate State representatives.
No significant items will be left unresolved over a prolonged period. The Commission will be informed of the results of the reviews of the individual Agreement State programs and copies of the review correspondence to the States will be placed in the NRC Public Document Room.
If the State program does not improve or if additional significant Category I deficiencies have developed, a staff finding that the program is not adequate will be considered and the NRC may institute proceedings to suspend or revoke all or part of the Agreement in accordance with Section 274j of the Act, as amended.
ENCLOSURE I i
l
SUMMARY
OF ASSESSMENTS AND COMMENTS FOR THE IOWA RADIATION CONTROL PROGRAM OCTOBER 12, 1991 TO SEPTEMBER 4, 1992 SCOPE OF REVIEW This follow-up program review was conducted in accordance with the Commission's Policy Statement for reviewing Agreement State Programs published in the Federal Reaister on May 28, 1992, and the internal procedures established by the Office of State Programs. The State's program was reviewed against the 30 program indicators provided in the guidelines. The review included inspector accompaniments, discussions with program management and staff and technical evaluation of selected license and compliance files.
The follow-up program review meeting with Iowa representatives was held during the period August 31, 1992 through September 4, 1992 in Des Moines. The State was represented by John R. Kelly, Director, Division of Health Protection, Daniel K. McGhee, Environmental Specialist and Thomas H. Wuehr, Environmental Specialist. The NRC was represented by James L. Lynch, Region III State Agreements Officer and B. J. Holt, Chief, Nuclear Materials Safety Section 1.
Mr. Lynch and Ms. Holt interviewed program staff, reviewed incident files and reviewed selected license and compliance files in the Radioactive Materials Program. Mr. Lynch also accompanied Mr. McGhee on a September 2, 1992 inspection of an industrial radiography license and Mr. Wuehr on September 3, 1992 portable and fixed gauge inspections.
CONCLUSION At this time, due to the continual degradation of the program, the staff is unable to offer a finding that the Iowa program for the regulation of agreement materials is adequate to protect public health and safety and compatible with NRC's program for regulation of similar materials. The management of the program has not provided sufficient support to the radioactive materials program over the past several years which leaves it in a condition which threatens to jeopardize the Agreement.
In order for the State to continue with the 274b program, the State will need to take quick and decisive action to address these problems. The NRC will support the State's efforts to upgrade the radioactive materials program to one that is both adequate and compati_ble. NRC intends to provide training and assistance to Iowa inspection and licensing staff. NRC will also provide copies of NRC procedures and regulatory guides as may be useful. NRC is requesting that Iows provide a detailed action plan to Region III within 30 days of the date of this letter so that NRC may provide timely and appropriate assistance. Also, as Mr. Flater and Mr. Lynch agreed, monthly status reports will be provided to Mr. Lynch so that NRC staff may monitor the progress of the program recovery.
STATUS OF PROGRAM RELATED TO PREVIOUS NRC FINDINGS The results of the previous follow-up review were reported to the State in a letter to Mr. Atchison dated December 27, 1991. Of the ten program indicators addressed during that review, only two were satisfactorily resolved and closed out prior to this meeting. The remaining eight areas remain as o en items, i
and are detailed in the following section of this enclosure.
ENCLOSURE 2 m
2 s
Several commitments were made in the January 6,1992 response letter which s
were not factual. These items are addressed in the transmittal letter and
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elsewhere in this enclosure.
CURRENT REVIEW COMMENTS AND RECOMMENDATIONS All 30 program indicators were reviewed and the State fully satisfies 18 of these indicators. Specific coments and recommendations for the remaining 12 indicators (including eight repeated from the previous fcllow-up review) are as follows:
1.
Inspector's Performance and Caoability is a Cateaory I Indicator. We consider the followina comment to be sionificant.
Comment Inspectors should be qualified to evaluate health and safety issues and be able to determine compliance with State regulations.
It was determined through accompaniments and interviews with the two inspectors that they had neither the training nor knowledge to perform many of the categories of inspections required in the Iowa program. The types of licenses which they are not yet qualified to inspect include: nuclear medicine, radiation therapy, teletherapy, nuclear pharmacies, broadscope research and development, well logging and large irradiators.
With the resignation of the Radioactive Materials Program Supervisor, a formal system of approval by supervision prior to the performance of inspections in new license categories has not been established.
Recomendation We recommend that the State take immediate action to train inspection personnel for all types of license programs and/or hire additional inspectors who are qualified to perform those types of inspections.
We recommend that a consultant be contracted to perform inspector training and to assist Iowa staff in the preparation of inspection and -
related administrative procedures.
We recommend that State personnel accompany NRC and other Agreement State inspectors for purposes of training when opportunities arise.
We recommend that inspectors demonstrate to supervisors, in a formal manner, an appropriate level of understanding with regard to regulations, guidance and policies prior to independently performing various types of inspections.
2.
Status of Inspection Procram is a Cateaory I Indicator.
We consider the followino comment to be sianificant.
Comment
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The inspection program should be adequate to assess licensee compliance with State regulations and license conditions. The State does not ENCLOSURE 2
3 currently have an inspection program capable of assessing license
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compliance for numerous licensee categories. This situation is due to
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the loss of inspection personnel and the fact that the program has not obtained technical expertise to assess licensee compliance.
The inspection staff was unable to provide an accurate accounting of licenses that were due (or overdue) for inspection. The inspection tracking system was last audited in October 1991. Updates to the tracking system since then are incomplete and, in some cases, inaccurate. The evaluation of the tracking system was complicated by the fact that numerous inspection reports were missing from the license files.
Recomendation We recommend that the State immediately obtain qualified technical support to allow the assessment of licensee compliance for all licenses.
We recommend that the inspection tracking system be evaluated and maintained in an accurate, updated fashion.
3.
Technical Ouality of Licensino Actions is a Cateoory I Indicator. We consider the followino comment to be sionificant.
Coment i
The technical quality of licensing actions appears to have been slightly
~
improved since the last follow-up review until the recent resignation of-the two senior staff members. The current licensing staff has very little experience and is not qualified, at this time, to review complex licensing actions. The casework review performed by the NRC identified several errors which were discussed with Iowa licensing staff.
At the time of the 1991 follow-up review, licensing audit checklists were provided to the State to help with casework audits as errors in licensing actions were noted which should have been detected during the management review of the completed actions. The State's January 6, 1992 response letter stated that the checklists would be used in casework audits, henceforth. The current review identified that the checklists have not been used since the last follow-up review, contrary to the January 6,1992 response letter.
The last follow-up review identified a number of licensing action submittals from the University of Iowa which had not been evaluated by Iowa staff. The response letter stated that the University submittals had been evaluated and incorporated into the license by amendment. The current review was unable to confirm whether the submittals were actually incorporated into the license. The current license does not reflect the appropriate changes with regard to the University's waste storage and incineration program.
Previous license amendments were missing from the license file which may have incorporated the changes, g
which may have later been removed. Current licensing staff personnel were unable to provide any explanation for the situation and were not s
able to locate the missing amendments.
ENCLOSURE 2
4 Becommendation
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We recomend that the State correct the licensing errors that were identified by NRC personnel and use audit checklists in the future to help identify errors and inconsistencies in licensing actions.
We recommend that personnel be given extensive training in licensing and that licensing training plans be drawn up for each reviewer to assess progress and to provide direction to the reviewers.
We recommend that the State search for the missing University of Iowa license documents, conferring with former licensing personnel, if necessary, to resolve this issue. The license should be modified, if appropriate.
4.
Staffino level is a Cateaory II Indicator. We consider the followina comment to be sianificant.
Comment A continuing staffing problem has existed in the Iowa radioactive materials program for years. At the time of the 1991 follow-up review, the State had a technical staffing level of 0.76 person-year per 100 licenses. That level was significantly less than the 1.0 to 1.5 level recommended by the NRC and was also less than the staffing level noted during the 1990 review.
As a result of the recent resignations of the two senior technical staff, the program is currently staffed by 1.75 working technical staff (junior grade) persons detailed to the program.
Considering the State's 227 licenses, the staffing level is 0.77 person-year per 100 licenses.
The lack of sufficient staff, and particularly senior staff, leaves the program in a very vulnerable position as the personnel have a heavy workload to maintain the program and are not sufficiently trained to perform basic functions such as the licensing and inspection of medical programs.
The NRC was notified by Governor Branstad's office on September 21, 1992 that two staff positions had been approved for the program. A technical staff of 2.3 to 3.4 is required to meet the recommended staffing levels.
At least one of the technical staff hired should be an individual with considerable experience in health physics.
Recommendation We recommend that, considering the current state of the program, that the State maintain the staffing level at the upper end of the suggested range so as to enable the program to develop beyond a borderline adequate and compatible program.
I ENCLOSURE 2
5 5.
Staff Supervision is a Cateaory II Indicator.
We consider the followina comment to be sianificant.
Comment The 1991 follow-up review identified a problem with staff supervision due to lack of staffing and the assignment of additional responsibilities to the program Director and Supervisor. The Supervisor has since left the Iowa program and has not yet been replaced. The Director still has a large number of programs under his authority which limits his involvement in the operations of the Radioactive Materials program. The lack of staffing, in particular senior technical staff, also contributes to the supervision problem.
Recommendation We recommend that the Radioactive Materials program appoint an individual to a Supervisor or Manager position for oversight of day-to-day activities in the program. We also recommend that the program Director spend increased time in the program for purposes of program oversight, personnel development and long-term planning.
6.
Office Eouipment and Succort Services is a Cateoory II Indicator.
Comment
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Prior to the last follow-up review, the program lost the secretary who
\\
developed and maintained the computerized tracking system.
The system provides program management with readily available information on the licensing backlog, due and overdue inspections, inspection history, licensees categorized by type, county, fees, etc.
The current secretary who is assigned half time to the radioactive materials program, has not been trained on the use of the. system. One of the technical staff has limited knowledge of the system.
Since the last review, technical staff has reverted back to a handwritten tracking system. The manual system takes additional technical staff effort which could be better used conducting inspections or perforuing license reviews and the system limits management's ability to review program parameters.
Recommendation We recommend that the State provide full-time secretarial support to the program. The individual (s) should have adequate training and experience j
with computers and software packages to use and maintain the program's computerized tracking system.
j i
7.
Licensina Procedures is a Cateaory 11 Indicator.
@ ent The licensing backlog is currently about 20%.
Licensing staff is I
limited as to their current ability to evaluate complex licensing actions due to recent staff turnover.
ENCLOSURE 2
~ - - +
--r s
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6 The January 6,1992 response letter to the 1991 follow-up review stated
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that licensing notebooks have been developed. This review identified that only one licensing notebook had been prepared and that was done prior to the 1991 review. Many of the omissions and errors found during our casework review may not have occurred if the licensing staff had access to a good set of documented procedures, guidance and licensing examples (licensing notebooks).
The January 6,1992 response letter also stated that pertinent NRC Information Notices provided to the State had been sent out. This review identified that the Information Notices, which warn licensees of safety concerns, had not been sent out to licensees as stated.
Subsequent to this review, on September 15, 1992, the Notices were sent to Iowa licensees.
Licensing files should be maintained in an orderly fashion to allow expedient, accurate retrieval of information. The casework review identified that approximately 25% of the licensing files reviewed had missing or misfiled documents, including 8 inspection reports missing from 26 files reviewed.
Recommendation We recommend that a plan be developed for reducing the licensing backlog. The plan should include milestones for assessing progress.
The State may wish to confer with Region III for assistance with complex license actions.
I We recommend that licensing notebooks be prepared for all types of licenses which are reviewed.
We recommend that a system be developed to maintain the license files in an orderly fashion and that the files be audited periodically to ensure that filing errors are corrected. We also recommend that inspection reports be tracked to insure that they are placed in the licensing files.
8.
Inspection procedures is a Cateoory II Indicator.
Comment Written inspection procedures have not been issued to the Radioactive Materials program technical staff. Procedures have not been provided to the staff to establish policies for conducting unannounced inspections, follow-up and closecut of previous violations, performing exit interviews with licensee management, interviewing workers and writing inspection reports and notices of violation. Since the senior inspection personnel have left the program, the current inspectors do not have the benefit of their knowledge and have no written procedures to help them understand the techniques for performing an inspection.
Due to the staffing shortage and personnel turnover, the writing of
[
inspection procedures has been assigned a low priority. Only two draft procedures have been prepared, both relating to the radon program.
ENCLOSURE 2
7 c
RecommendatiRD
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implementation of inspection procedures to benefit the personnel who are We recommend that the State place priority on the development and presently learning to perform inspections as well as those personnel who are to be hired in the near future. We think that the State's proposal to hire a consultant to draw up the procedures and train personnel in their use is a viable option.
9.
Administrative Procedures is a Catecory II Indicator.
Comment The State does not have a set of written procedures describing the administrative aspects of the Radioactive Materials program.
Procedures have not been documented for handling incoming mail from licensees, filing license documents, maintaining license files, processing fees, assigning license numbers, entering new licenses into the inspection system, tracking expired licenses, tracking licenses due for inspection, etc. The program secretary, assigned to the program for a few months, was unable to explain how many of the above procedures were performed and did not have access to written procedures to help her learn the systems.
Pecomendation
/
We recommend that the State prepare written procedures for 1
administrative functions in the program. The procedures should be taught to the secretarial / administrative staff so that the technical staff is not burdened performing administrative functions and can concentrate on technical issues.
10.
Confirmatory Measurements is a Cateaory 11 Indicator.
Comment Survey instruments used to perform confirmatory measurements during inspections should be calibrated within the same time interval as required for the licensee being inspected (e.g., radiography licensees must calibrate instruments at three-month intervals). No calibration reports for any of the program's instruments were dated after November 1991. At least one radiography inspection, with confirmatory measurements, has been performed by the Iowa inspectors three months after the last calibration of the program's survey instruments.
Recommendation We recommend that a " tickler file" system be established for survey instrument calibrations and that prior to performing confirmatory measurements, the survey instrument's last calibration date be verified.
k ENCLOSURE 2
8 II.
Manacement is a CateQorY II Indicator.
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Comment Supervisory review of inspection reports should be performed so that program management may ensure appropriate and consistent inspection and enforcement actions.
Eight of 26 inspection reports reviewed during the casework audit did not have approval signatures. A similar supervisory review of complex licensing actions should be performed.
In June 1992, the University of Iowa license (Type A broadscope) was renewed and there is no evidence of a supervisory review.
Recommendation We recommend that program management perform reviews of all inspection ~
reports and of significant licensing actions.
12.
Trainino is a Cateoory II Indicator.
Comment The Radioactive Materials program staff should be afforded opportunities for training that are consistent with the needs of the program.
In early 1992, the Agreement States Officer offered to arrange licensing training in Region III for Mr. McGhee. He was unable to attend what would have been valuable training due to a temporary prohibition on out-of-state travel.
Recomendation We recommend that future training courses which are important for the development of key program personnel be given priority authorization.
SUMMARY
OF DISCUSSIONS WITH STATE REPRESENTATIVES Ms. Holt and Mr. Lynch presented the results of this follow-up program review' to Messrs. Atchison, Kelly, Fries and Flater during a summary meeting held on September 4, 1992. Mr. Kammerer, Director, Office of State Programs and l
Mr. Davis, Regional Administrator, Region III, also, participated in the j
meeting.
1 The State was informed that the Radioactive Materials program was in critical shape and that significant actions must be taken immediately to improve the program or the NRC would consider initiating the reassertion of authority over Iowa licensees.
4 The staffing problem was. discussed in detail, which is more serious now than 1
at the time of the last review due to the resignation of the two experienced i
I licensing / inspection people. The NRC expressed concern that trained personnel are not currently available to license or inspect complex license ~e programs, including medical and broadscope licenses.
i ENCLOSURE 2 l
9 Mr. Kelly discussed a planned reorganization which would allow the program i-Director more' time to manage the Radioactive Materials program. This move was
(
applauded by the NRC as the lack of management supervision was. identified as a program weakness during the past three reviews.
Mr. Kamerer stated that he intended, in the near future, to call the Iowa governor's office to discuss problems identified during the review, particularly the staffing issue.
Noting the coments made about administration deficiencies in the program, Mr. Atchison imediately comitted to obtain contractual support to solve some of those problems.
The NRC comitted to providing short-term support to the Iowa program. Region III arranged to have a Section Chief provide licensing training to the license reviewers and encouraged the State to cross-train other Bureau personnel in this type of specialized training so that additional support is available in the event of another staffing shortage. Region III also informed the State that Mr. Lynch would be available on a continuing basis to assist and train employees. The State was also encouraged to accompany Region III inspectors on materials inspections and to contact other Agreement State programs for similar assistance.
Mr. Atchison was informed that the results of the review would be reported in a letter to him from Mr. Kamerer and that a written response would be-requested.
j Mr. Atchison and Mr. Kelly then thanked the NRC for their past and anticipated i
future assistance in our mutual goal of public health and safety.
i h
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ENCLOSURE 2 I
QUESTION 36 q'
f UNITED STATES 3
j NUCLEAR REGULATORY COMMISSION r
WASHINGTON, D.C. 3DIEH001 g,.....j April 26, 1993
(
MEMORANDUM FOR:
The Chairman Comissioner Rogers Comissioner Curtiss Comissioner Remick Comissioner de Planque FROM:
James M. Taylor Executive Director for Operations
SUBJECT:
PROPOSED REVIEW LETTER FOR THE 1993 IOWA AGREEMENT STATE PROGRAM FOLLOW-UP REVIEW In SECY-92-360, "Results of the 1992 Follow-up Review of the Iowa Agreement Program," dated October 22, 1992, I informed the Comission of the status of the Iowa Agreement State program and the additional actions to be taken by the NRC staff.
I indicated that I would be receiving monthly status reports from the Office of State Programs and Region III on the progress in the Iowa program and if insufficient progress was made that the staff would recomend that the Commission find the Iowa program inadequate and comence to take back the 274b program. These status reports have documented Iowa's actions.
In a follow-up review of the Iowa program on February 26, 1993, the staff found that the program has made continuing progress to correct serious ranagement and programmatic deficiencies identified during the last review.
Eight of the twelve indicators identified during the last review as deficient have been closed out. The four remaining indicators open are two Category I and two Category 11 indicators. A finding of adequacy and compatibility cannot be made pending the retolution of the Category I indicators.
Two of the Category I coments and one of the Category II coments deal with the securing of an adequate number of trained staff. The State has informed us,that since the follow-up review was conducted, a recently hired health physicist has resigned. The staffing problems in Iowa have been a continuous concern. The State informed us that they are taking measures to fill the vacant position and we are encouraging the State to expedite the hiring process. However, this will impact upon the time it takes the State to resolve the remaining deficiencies and return to a level that is adequate and compatible.
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The Commission 2
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We plan to make a routine review of the Iowa program in December 1993. At that time, we will make a final assessment in terms of the adequacy and compatibility of the Iowa program. Attached is the proposed 1993 review i
letter on the State of Iowa's Agreement State program.
I plan to transmit the review letter to Iowa five working days from the date of this memorandum.
i OriginalsignN!by James M. Taylor James M. Taylor Executive Director
~
for Operations
Attachment:
As stated cc: SECY OGC OCA OPA
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UNITED STATES p
M1 E NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2006540(n
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Mr. Christopher G. Atchison, Director Iowa Department of public Health Des Moines, IA 50319
Dear Mr. Atchison:
This letter refers to the discussion Mr. Hubert Miller, Region III Deputy Administrator and Mr. James Lynch, State Agreements Officer held with you, Mr. David Fries, Director, Division of Administration and planning, Mr. Donald Flater, Chief, Bureau of Radiological Health, and Mr. Daniel McGhee, Environmental Specialist, on February 26, 1993.
As a result of our follow-up review of the State's radiation control program, our view is that the Iowa program has made continuing progress to correct serious management and programmatic deficiencies identified during the last review, however, a finding of adequate and compatible cannot be made at this time.
The past three reviews, in July 1990, October 1991 and September 1992, resulted in the withholding of a finding of adeguate and I
compatible due to significant programmatic deficiencies.
The current review found the radioactive materials program has shown progress.
Eight of the 22 indicatucs identified during the last review as deficient have been closed out.
We commend the Iowa Department of Health on the development of the radioactive materials computerized tracking system.
This system is well designed and automates many administrative functions which allow program staff to concentrate on technical issues.
The system also provides an excellent management tool for the program.
While these efforts are encouraging, additional effort by the Department is needed to reestablish an adequate radioactive materials program.
Our review identified the need for additional attention in the following areas:
maintenance of adequate staffing levels; completion of technical training for inspectors / reviewers; and quality assurance reviews of licensees and reports by management.
In this regard, the recent restructuring of the Bureau of Environmental Health which is allowing Mr. Flater increased interaction time with the radioactive materials program is important.
Active and consistent management of the materials program is essential to f
4 f
i i
Christopher G. Atchison 2
improvement and stability of Iowa's program.
Also, as we discussed in our exit meeting, we recommend that you develop a program plan outlining program goals, strategies and priorities.
In addition to ongoing efforts to resolve previously identified deficiencies, the program faces numerous other tasks such as development of regulations, regulatory guides and internal procedures.
A plan should help you deal most effectively with these numerous competing demands.
In addition, the notification that the recently hired health physicist will be resigning is of concern.
We understand that you are taking measures to fill this position and we encourage the expediting of the hiring process.
As the State has not yet reestablished an adequate and compatible program, the NRC offers continued short-term assistance to you to achieve our common goal of public health and safety by providing licensing and inspection training and technical assistance.
Region III licensee reviewers and Mr. Lynch will provide the training and assistance to your staff.
We plan to conduct a full review of your radioactive materials l
program December 6-10, 1993.
At that time, we will determine whether the program is adequate and compatible with NRC programs.
In the meantime, we request that monthly status reports continue to be provided to Mr. Lynch so that NRC staff may monitor the progress of the program recovery. contains an explanation of our policies and practices for reviewing Agreement State programs. is a summary of our assessments and comments which were discussed with you and your staff at the conclusion of the review.
As stated t
earlier, we request specific responses from the State on the current review comments and recommendations in Enclosure 2 and in this letter within 45 days of this letter date.
J In accordance with NRC practice, I an also enclosing a copy of this letter for placement in the State's public Document Room or otherwise to be made available for public review.
i 1
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,(
Christopher G. Atchison 3
1 I appreciate the courtesy and cooperation extended the NRC staff during the review.
I am looking forward to your response.
l Sincerely, i
Carlton Kammerer, Director l
Office of State Programs Inclosures:
As stated
'l ec w/encis-John R.
Kelly, Director Division of Health Protection i
Donald A. Flater, Chief Bureau of Radiological Health A. Bert Davis, Regional Administrator NRC Region III Hubert J. Miller, Deputy Regional Administrator NRC Region III 8
State Public Document Room
{
NRC Public Document Room
'l Stephen Brown, State Liaison Officer t
5
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Aeolication of aGuidelines for NRC Review of Aareement State Radiation Control Procrams" The " Guidelines for NRC Review of Agreement State Radiation Control Programs," were published in the Federal Reaister on May I
28, 1992, as an NRC Policy Statement.
The Guidelines provide 30 indicators for evaluating Agreement State program areas.
Guidance as to their relative importance to an Agreement State program is provided by categorizing the indicarors into two categories.
Category I indicators address program functions which directly relate to the State's ability to protect the public health and safety.
If significant problems exist in several Category I indicator areas, then the need for improvements may be critical.
Category II indicators address program functions which provide essential technical and administrative support for the primary program functions.
Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or more of the principal program
- areas, i.e.,
those that fall under Category I indicators.
Category II indicators frequently can be used to identify underlying problems that are causing, or contributing to, difficulties in Category I indicators.
It is the NRC's intention to use these categories in the following manner.
In reporting findings to State management, the NRC will indicate the category of each comment made.
If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety and is compatible with the NRC's program.
If one or more significant Category I comments are provided, the State will be notified that the program deficiencies may seriously affect the State's ability to protect the public health and safety and that the need of improvement in par.ticular program areas is critical.
If, following receipt and evaluation, the State's response appears satisfactory in addressing the significant Category I comments, the staff may offer findings of adequacy and compatibility as appropriate or defer such offering until the State's actions are examined and their effectiveness confirmed in a subsequent review.
If additional information is needed to evaluate the State's actions, the staff may request the information through follow-up correspondence or perform a follow-up or special, limited review.
NRC staff may hold a special meeting with appropriate State representatives.
No significant items will be left unresolved over a prolonged period.
The Commission will be informed of the results of the reviews of the individual Agreement State programs and copies of the review correspondence to the States will be placed in the NRC Public Document Room.
If the State program does not improve or if additional significant Category I deficiencies have developed, a
staff finding that the program is not adequate will be considered and the NRC may institute proceedings to suspend or revoke all or part of the Agreement in accordance with Section 274j of the Act, as amended.
ENCLOSURE 1
SUMMARY
OF ASSESSMENTS AND COMMENTS FOR THE IOWA RADIATION CONTROL PROGRAM SEPTEMBER 5, 1992 TO FEBRUARY 21, 1993
{
SCOPE OF REVIEW This follow-up program review was conducted in accordance with the Commission's Policy Statement for reviewing Agreement State Programs published in the Federal Reaister on May 28, 1992, and the internal procedures established by the Office of State Programs.
The State's program was reviewed against the 30 program indicators provided in the guidelines.
The review included inspector accompaniments, discussions with program management and staff and technical evaluation of selected license and compliance files.
The follow-up program review meeting with Iowa representatives was held during the period February 22-26, 1993 in Des Moines.
The State was represented by Donald A. Flater, Chief, Bureau of Radiological Protection, Daniel K. McGhee, Environmental Specialist, Thomas H. Wuehr, Environmental Specialist and Reginald F. Glick, Environmental Specialist.
The NRC was represented by Hubert J. Miller, Region III Deputy Administrator and James L. Lynch, Region III State Agreements Officer (RSAO).
Mr. Lynch interviewed program staff, reviewed procedures and selected license and compliance files in the Radioactive Materials Program.
He also accompanied Mr. McGhee on a February 23, 1993 inspection of an academic licensee and g
Mr. Wuehr on a February 24, 1993 portable gauge inspection.
Mr. Miller participated in several interviews and represented NRC management at the exit meeting.
CONCLUSION At this time, due to several unresolved issues, the staff is unable to offer a finding that the program is adequate and compatible.
Although much progress has been made, further concentrated efforts are needed to upgrade the radioactive materials program to one that is both adequate and compatible.
NRC intends to continue to provide training and assistance to Iowa inspection and licensing staff to assist with this goal.
As we discussed during the follow-up review exit meeting on February 26, 1993, it is our view that development of a program plan would likely help you significantly as you continue efforts to resolve past deficiencies and otherwise carry out the various aspects of the Radioactive Materials Program.
We provided you with an example of such a plan in our March 9, 1993 letter to Mr. Flater.
We stand ready to provide assistance to you in the development of this plan.
STATUS OF PROGRAM RELATED TO PREVIOUS NRC FINDINGS The results of the previous follow-up review were reported to the State in a letter to Governor Branstad dated October 22, 1992.
g Of the thirty program indicators, 12 were determined to be deficient at that time, 5 of those comments were considered to be significant.
The NRC was unable to offer a finding that the Iowa program was adequate and co=patible.
The Iowa Department of
2 Public Health (IDPH) has taken actions to satisfy 8 of the indicators since the October 1992 follow-up review.
The i
remaining 4 indicators are currently being addressed by the State but are not yet resolved.
The unresolved specific comments and recommendations from the 1992 follow-up review along with current i
findings and recommendations are detailed in the following I
section.
FOLLOW-UP ASSESSMENTS TO THE OCTOBER 1992 COMMENTS AND RECOMMENDATIONS 1.
Inspector's Performance and canability (catecorv I Indicator) sienificant comment comrent Inspectors should be qualified to evaluate health and safety issues and be able to determine compliance with State regulations.
It was determined through accompaniments and interviews with the two inspectors that they had neither the training nor knowledge to perform many of the categories of inspections required in the Iowa program.
The types of licenses which they are not yet qualified to inspect include:
nuclear medicine, radiation therapy, teletherapy, nuclear pharmacies, broad scope research and development, well logging and large irradiators.
With the resignation of the Radioactive Materials Program Supervisor, a formal system of approval by supervision prior to the performance of inspections in new license categories has not been established.
Recommendation We recommended that the State take immediate action to train inspection personnel for all types of license programs and/or hire additional inspectors who are qualified to perform those types of inspections.
1 We recommended that a consultant be contracted to perform i
inspector training and to assist Iowa staff in the preparation of inspection and related administrative j
procedures.
We recommended that State personnel accompany NRC and other Agreement State inspectors for purposes of training when opportunities arise.
We recommended that inspectors demonstrate to supervisors, in a formal manner, an appropriate level of understanding with regard to regulations, guidance and policies prior to j
independently performing various types of inspections.
j i
3 Current Status An inspection training program is ongoing.
Inspection f
procedures and improved field notes with regulatory references have been developed by a consultant and all three inspectors have been instructed in their use.
The RSAO and the IDPH consultant have accompanied the inspectors on inspections providing training and auditing performance.
Inspectors routinely communicate with the RSAO regarding inspection issues and training in materials licensing provided by the NRC.
This contributes directly to a better understanding of licensee programs by the IDPH staff.
IDPH staff have been scheduled for attendance at NRC-sponsored training courses in various regulatory program areas.
A consultant was hired and has provided several training sessions on inspection issues and has performed inspector accompaniments.
He has been retained on contract for ongoing consultation and training.
Periodic inspection refresher training is planned.
An Inspection Manual was prepared by the consultant which includes inspection procedures, inspection priorities, narrative report guidance and updated field note reports.
He is currently preparing an Enforcement Manual which includes the enforcement policy, procedures, boilerplated letters and citations.
All three inspectors accompanied an NRC inspector during routine inspections of NRC licenses in Iowa.
Agreements have been made with other States for accompaniments, t
however, none have been performed to date.
Iowa personnel have been concentrating on completion of Iowa inspections.
A qualification journal is being developed by the consultant for inspectors and reviewers.
At present, NRC qualification checklists are used.
Comments resulting from inspection accompaniments are used to judge inspectors' level of knowledge.
Follow-up Recommendations We recommend that IDPH inspectors be provided additional training and experience for all types of licensee programs, including complex programs such as radiation therapy, broad scope research and development and nuclear laundries.
We recommend that qualification journals continue to be developed for assessment of staff progress and employee guidance.
I i
o.
4 2.
Status of Inspection Procram (Catecorv I Indicator) sienificant Comment t
Comment The inspection program should be adequate to assess licensee compliance with State regulations and license conditions.
The State does not currently have an inspection program capable of assessing license compliance for numerous licensee categories.
This situation is due to the loss of inspection personnel and the fact that the program has not obtained technical expertise to assess licensee compliance.
The inspection staff was unable to provide an accurate accounting of licenses that were due (or overdue) for inspection.
The inspection tracking system was last audited in October 1991.
Updates to the tracking system since then are incomplete and, in some cases, inaccurate.
The evaluation of the tracking system was complicated by the fact that numerous inspection reports were missing from the license files.
Recommendation We recommended that the State immediately obtain qualified technical support to allow the assessment of licensee compliance for all licenses.
We recommended that the inspection tracking system be evaluated and maintained in an accurate, updated fashion.
Current Statug The two inspectors with the program at the time of the last review have received considerable amounts of training to increase their inspection skills and competence.
The training has been given by the consultant and by the RSAO.
These inspectors have performed inspections on a regular basis, and along with licensing training, have added to their knowledge and experience.
The new inspector, with a Masters degree in Health Physics, was hired to provide health physics expertise to the program.
He is currently being trained in the inspection program which includes the accompaniment of other inspectors.
A new tracking system capable of tracking inspections, licensing actions, fees, reciprocity authorizations and expirations was developed.
The system is also used to print notices, letters and reports.
An arrangement was made with the Bureau of Information Management to have a programmer / analyst devote approximately 80% of her time to g
develop the system.
The result is an excellent product which allows for better management of the program.
4 a
5 Follow-uo Recommendation We recommend that inspectors be provided additional training g-and be given the opportunity to inspect or accompany qualified inspectors for the various types of programs which are licensed in the State.
3.
staffine Level (catecory II Indicator) sienificant comment Comment A continuing staffing problem has existed in the Iowa radioactive materials program for years.
At the time of the 1991 follow-up review, the State had a technical staffing level of 0.76 person-year per 100 licenses.
That level was significantly less than the 1.0 to 1.5 level recommended by the NRC and was also less tr.m. the staffing level noted during the 1990 review.
As a result of the recent resignations of the two senior technical staff, the program is currently staffed by 1.75 working technical staff (junior grade) persons detailed to the program.
Considering the State's 227 licenses, the staffing level is 0.77 person-year per 100 licenses.
The lack of sufficient staff, and particularly senior staff, leaves the program in a very vulnerable position as the personnel have a heavy workload to maintain the program and are not sufficiently trained to perform basic functions such as the licensing and inspection of medical programs.
The NRC was notified by Governor Branstad's office on September 21, 1992 that two staff positions had been approved for the program.
A technical staff of 2.3 to 3.4 is required to meet the recommended staffing levels.
At least one of the technical staff hired should be an individual with considerable experience in health physics.
Recommendation We recommended that, considering the current state of the program, that the State maintain the staffing level at the upper end of the suggested range so as to enable the program 1
to develop beyond a borderline adequate and compatible program.
Current Status The technical staffing level is currently at 3.4 FTE which is at the upper end of the suggested range as recommended by the NRC.
IDPH plans to reduce the technical staffing level to about 2.5 FTE when the licensing and inspection backlogs are completely eliminated.
The current projection for the reduction is June 1, 1993.
After that time, the workload will be closely monitored by the Environmental Specialist III who, as the need arises, can request from the Bureau Chief, the detailing of the other O.9 FTE to assist the radioactive materials program.
IDPH also projects that the
F I
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6 k
tracking system, as it becomes more sophisticated, will further reduce the technical staff workload..The State has informed us that since this follow-up review was conducted, the recently hired junior health physicist has submitted-his resignation.
However, the State also informed us that they are taking active measures to fill this position and are currently considering several applicants.
Follow-un Recommendation We recommend that the State maintain the radioactive materials staffing level at the upper and of the suggested range (i.e., 1.5 FTE per 100 licenses).
The NRC stressed in this, and in previous reviews, that a small program such as j
Iowa's is vulnerable to problems resulting from the loss of staff.
Pending the staff gaining considerable experience, a higher staffing ratio should be maintained.
l 4.
Manacement (Catecory II Indicator).
~ '
Comment Supervisory review of inspection reports should be performed l
so that program management may ensure appropriate and consistent inspection and enforcement actions.. Eight of 26 inspection reports reviewed during the casework audit did not have approval signatures.
A similar supervisory review.
of complex licensing actions should-be performed.
In June 1992, the University of Iowa license (Type A broad scope) was renewed and there is no evidence of a supervisory review.
I Recommendation We recommended that program management perform reviews of all inspection reports and of significant licensing actions.
Current Status The Bureau Chief is currently reviewing and concurring on all inspection reports and license actions.
His reviews are performed after another independent review by one of the u
technical staff.
The NRC file audits during the last review identified numerous errors and omissions in documents which are sent to licensees.
This review by the.NRC detected 1
fewer errors but found some minor problems, such as omissions of names of persons _ accompanying inspectors, j
misspelled words, and the omission of sufficient detail on violations discussed in inspection reports.
i
1 e
7 I
Follow-un Recommendation We recommend that additional efforts be made by program management to assure that inspection and licensing documentation is sound.
The recent reorganization should allow additional time to be devoted to this area.
SUMMARY
OF DISCUSSIONS W.TTH STATE REPRESENTATIVEE Mr. Miller and Mr. Lynch presented the results of this follow-up program review to Messrs. Atchison, Fries, Flater and McGhee during a summary meeting held on February 26, 1993.
The State was informed that the radioactive materials program was improving but had not reached a point where the NRC could consider the program adequate and compatible.
The staffing situation was discussed in detail, with concerns noted by the NRC that with a proposed 2.5 FTE technical staff, the program is vulnerable and in danger of failing if one or more key personnel should leave the program.
Mr. Atchison discussed the recent reorganization which would allows the Bureau Chief more time to manage the Radioactive Materials program.
This move was applauded by the NRC as the lack of management supervision has been consistently identified as a program weakness in past reviews.
Mr. Atchison and Mr. Fries committed to the continuation of contractual support for the radioactive materials program in training and administrative areas.
The NRC committed to continue providing short-term support to the Iowa program.
These licensing and inspection training efforts will be coordinated by Mr. Lynch.
Mr. Miller suggested that a program (operating) plan might be beneficial to the Radioactive Materials program.
The plan would discuss the program's goals, strategies and priorities.
Special attention should be given to the staffing needed to accomplish each goal.
He promised to send Mr. Flater a copy of a plan in use by the NRC for guidance.
Mr. Atchison was informed that the resulte af the review would be reported in a letter to him from Mr. Carlton Kammerer, Director, office of State Programs and that a written response would be requested.
k
[.uy\\o QUESTION 36.
UNITED $TATES P
NUCLEAR REGULATORY COMMISSION e
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Hay 6, 1993 Mr. Christopher G. Atchison, Director Iowa Department of Public Health Des Moines, IA 50319
Dear Mr. Atchison:
This letter refers to the discussion Mr. Hubert Miller, Region III Deputy Administrator and Mr. James Lynch, State Agreements officer held with you, Mr. David Fries, Director, Division of Administration and Planning, Mr. Donald Flater, Chief, Bureau of Radiological Health, and Mr. Daniel McGhee, Environmental Specialist, on February 26, 1993.
As a result of our follow-up review of the State's radiation control program, our view is that the Iowa program has made continuing progress to correct serious management and programmatic deficiencies identified during the last review, however, a finding of adequate and compatible cannot be made at this time.
The past three reviews, in July 1990, October 1991 and September 1992, resulted in the withholding of a finding of adequate and compatible due to significant programmatic deficiencies.
The current review found the radioactive materials program has shown progress.
Eight of the 12 indicators identified during the last review as deficient have been closed out.
We commend the Iowa Department of Health on the development of the radioactive materials computerized tracking system.
This system is well designed and automates many administrative functions which allow program staff to concentrate on technical issues.
The system also provides an excellent management tool for the program.
While these efforts are encouraging, additional effort by the Department is needed to reestablish an adequate radioactive materials program.
Our review identified the need for additional attention in the following areas:, maintenance of adequate staffing levels; completion of technical training for inspectors / reviewers; and quality assurance reviews of licensees and reports by management.
In this regard, the recent restructuring of the* Bureau of Environmental Health which is allowing Mr. Flater increased interaction time with the radioactive materials program is important.
Active and consistent management of the materials program is essential to i
p@r i
4
e Christopher G. Atchison 2
improvement and stability of Iowa's program.
Also, as we discussed in our exit meeting, we recommend that you develop a program plan outlining program goals, strategies and priorities.
In addition to ongoing efforts to resolve previously identified deficiencies, the program faces numerous other tasks such as development of regulations, regulatory guides and internal procedures.
A plan should help you deal most effectively with these competing demands.
The notification that the recently hired health physicist has resigned is of serious' concern.
Staffing is a key element in the steps that must be addressed for the program to obtain compatibility and adequacy.
We understand that you are taking measures to fill this position 'nd we consider the expediting of hiring to be important.
As the State has not yet reestablished an adequate and compatible program, the NRC offers continued short-term assistance to you to achieve our common goal of public health and safety by providing licensing and inspection training and technical assistance.
Region III licensee reviewers and Mr. Lynch will provide the training and assistance to your staff.
We plan to conduct a full review of your radioactive materials program December 6-10, 1993.
At that time, we will determine whether the program is adequate and compatible with NRC programs.
Based on the progress to date, and the nature of the additional improvements that need to be made, we anticipate that you will make every effort to obtain a finding of adequacy and compatibility at that time.
In the meantime, we request that monthly status reports continue to be provided to Mr. Lynch so that NRC staff may monitor the progress of the program recovery.
a contains an explanation of our policies and practices for reviewing Agreement State programs. is a summary of our assessments and comments which were discussed with you and your staff at the conclusion of the review.
As stated earlier, we request specific responses from the State on the current review comments and recommendations in Enclosure 2 and in this letter within 45 days of this letter date.
In accordance with NRC practice, I an also enclosing a copy of this letter for placement in the State's Public Document Room or otherwise to be made available for public review.
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' . k Christopher G. Atchison 3
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I appreciate the courtesy and cooperation extended the NRC staff during the review.
I am looking forward to your response.
Sincerely, original signed by Carlton Kammerer Carlton Kammerer, Director Office of State Programs
Enclosures:
As stated cc w/encls:
John R. Kelly, Director -
Division of Health Protection j
Donald A.
Flater, Chief Bureau of Radiological Health A. Bert Davis, Regional Administrator F
i NRC Region III Hubert J. Miller, Deputy Regional Administrator NRC Region III State Public Document Room NRC Public Document Room Stephen Brown, State Liaison Officer Distribution:
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ADD 11 cation of " Guidelines for NRC Review of Acreement State Radiation Control Procrams"
I The " Guidelines for NRC Review of Agreement State Radiation j
Control Programs," were published in the Federal Recister on May j
28, 1992, as an NRC Policy Statement.
The Guidelines provide 30 indicators for evaluating Agreement State program areas.
Guidance as to their relative importance to an Agreement State program is provided by categorizing the indicators into two categories.
Category I indicators address program functions which directly.
relate to the State's ability to protect the public health and safety.
If significant problems exist in several Category I indicator areas, then the need for improvements may be critical.
Category II indicators address program functions which provide essential technical and administrative support for the primary progran functions.
Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or more of the principal progrhm
- areas, i.e.,
those that fall under Category I indicators.
Category II indicators frequently can be used to identify underlying problems that are causing, or contributing to, difficulties in Category I indicators.
It is the NRC's intention to use these categories in the following manner.
In reporting findings to State management, the NRC will indicate the category of each comment made.
If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety and is compatible with the NRC's program.
If one or more significant Category I comments are provided, the State will be notified that the program deficiencies may seriously affect the State's ability to protect the public health and safety and that the need of improvement in particular program areas is critical.
If, following receipt and evaluation, the State's response appears satisfactory in addressing the significant Category I comments, the staff may offer findings of adequacy and compatibility as appropriate or defer such offering until the State'8 BCtlons are examined and their effectiveness confirmed in a subsequent review.
If additional information is needed to evaluate the State's actions, the staff may request the information through follow-up correspondence or perform a follow-up or special, limited review.
NRC staff may hold a special meeting with appropriate State representatives.
No significant items will be left unresolved over a prolonged period.
The Commission will be informed of the results of the reviews of the individual Agreement State programs and copies of the review correspondence to the States will be placed in the NRC public Document Room.
If the State program does not improve or if additional significant Category I deficiencies have developed, a staff finding that the program is not adequate will be considered and the NRC may institute proceedings to suspend or revoke all or part of the Agreement in accordance with Section 274j of the Act, as amended.
ENCLOSURE 1
SUMMARY
OF ASSESSMENTS AND COMMENTS FOR THE IOWA RADIATION CONTROL PROGRAM SEPTEMBER 5,1992 TO FEBRUARY.-21, 1993
.'?
SCOPE OF REVIEW This follow-up program review was conducted in accordance with the Commission's Policy Statement for reviewing Agreement State Programs published in the Federal Reaister on May 28, 1992, and the internal procedures established by the Office of State Programs.
The State's program was reviewed against the 30 program indicators provided in the guidelines.
The review included inspector accompaniments, discussions with program management and staff and technical evaluation of selected license and compliance files.
The follow-up program review neeting with Iown representatives was held during the period February 22-26, 1993 in Des Moines.
The State was represented by Donald A. Flater, Chief, Bureau of Radiological Protection, Daniel K. McGhee, Environmental specialist, Thomas H. Wuehr, Environmental Specialist and Reginald F. Glick, Environmental Specialist.
The NRC was represented by Hubert J. Miller, Region III Deputy Administrator and James L. Lynch, Region III State Agreements Officer (RSAO).
Mr. Lynch interviewed program staff, reviewed procedures and selected license and compliance files in the Radioactive Materials Program.
He also accompanied Mr. McGhee on a February 23, 1993 inspection of an academic licensee and Mr. Wuehr on a February 24, 1993 portable gauge inspection.
Mr. Miller participated in several interviews and represented NRC management at the exit meeting.
CONCLUSION At this time, due to several unresolved issues, the staff is unable to offer a finding that the program is adequate and compatible.
Although much progress has been made, further concentrated efforts are needed to upgrade the radioactive materials program to one that is both adequate and compatible.
NRC intends to continue to provide training and assistance to Iowa inspection and licensing staff to assist with this goal.
As we discussed during the follow-up review exit meeting on February 26, 1993, it is our view that development of a program plan would likely help you significantly as you continue efforts to resolve past deficiencies and otherwise carry out the various aspects of the Radioactive Materials Program.
We provided you with an example of such a plan in our March 9, 1993 letter to Mr. Flater.
We stand ready to provide assistance to you in the development of this plan.
STATUS OF PROGRAM RELATED TO PREVIOUS NRC FINDINGS The results of the previous follow-up review were reported to the State in a letter to Governor Branstad dated October 22, 1992.
Of the thirty program indicators, 12 were determined to be deficient at that time, 5 of those comments were considered to be significant.
The NRC was unable to offer a finding that the Iowa program was adequate and compatible.
The Iowa Department of
2 Public Health (IDPH).has taken actions to satisfy 8 of the indicators since the October 1992 follow-up review.
The remaining 4 indicators are currently being addressed by the State but are not yet resolved.
The unresolved specific comments and recommendations from the 1992 follow-up review along with current findings and recommendations are detailed in the following section.
FOLLOW-UP ASSESSMENTS TO THE OCTOBER 1992 COMMENTS AND RECOMMENDATIONS 1.
Inspector's Performance and Capability (catecory I Indicator)
Sicnificant Comment Comment Inspectors should be qualified to evaluate health and safety issues and be able to determine compliance with State regulations.
It was determined through accompaniments and interviews with the two inspectors that they had neither the training nor knowledge to perform many of the categories of inspections required in the Iowa program.
The types of licenses which they are not yet qualified to inspect include:
nuclear medicine, radiation therapy, teletherapy, nuclear pharmacien, broad scope research and development, well logging and large irradiators.
i With the resignation of the Radioactive Materials Program Supervisor, a formal system of approval by supervision prior to the performance of inspections in new license categories has not been established.
Recommendation We recommended that the State take immediate action to train inspection personnel for all types of license programs and/or hire additional inspectors who are qualified to perform those types of inspections.
We recommended that a consultant be contracted to perform inspector training and to assist Iowa staff in the preparation of inspection and.related administrative procedures.
We recommended that State personnel accompany NRC and other Agreement State inspectors for purposes of training when opportunities arise.
We recommended that inspectors demonstrate to supervisors, in a formal manner, an appropriate level of understanding with regard to regulations, guidance and policies prior to
(
independently performing various types of inspections.
3 Current Status
.-f An inspection training program is ongoing.
Inspection procedures and improved field notes with regulatory references have been developed by a consultant and all three inspectors have been instructed in their use.
The RSAO and the IDPH consultant have accompanied the inspectors on inspections providing training and auditing performance.
Inspectors routinely communicate with the RSAO regarding inspection issues and training in materials licensing provided by the NRC.
This contributes directly to a better understanding of licensee programs by the IDPH staff.
IDPH staff have been scheduled for attendance at NRC-sponsored training courses in various regulatory program areas.
A consultant was hired and has provided several training sessions on inspection issues and has performed inspector accompaniments.
He has been retained on contract for ongoing consultation and training.
Periodic inspection refresher training is planned.
Ah Inspection Manual was prepared by the consultant which includes inspection procedures, inspection priorities, narrative report guidance and updated field note reports.
He is currently preparing an Enforcement Manual which
(
includes the enforcement policy, procedures, boilerplated letters and citations.
All three inspectors accompanied an NRC inspector during routine inspections of NRC licenses in Iowa.
Agreements have been made with other States for accompaniments, however, none have been performed to date.
Iowa personnel have been concentrating on completion of Iowa inspections.
A qualification journal is being developed by the consultant for inspectors and reviewers.
At present,RNRC qualification checklists are used.
Comments resulting from inspection accompaniments are used to judge inspectors' level of knowledge.
Follow-up Recommendations We recommend that IDPH inspectors be provided additional training and experience for all types of licensee programs, including complex programs such as radiation therapy, broad scope research and development and nuclear laundries.
We recommend that qualification journals continue to be developed for assessment of staff progress and employee guidance.
I
4 2.
status of Insoec' tion Procram (Catecory I Indicator)
((
Eienificant comment comment The inspection program should be adequate to assess licensee compliance with State regulations and license conditions.
The State does not currently have an inspection program capable of assessing license compliance for numerous licensee categories.
This situation is due to the loss of inspection personnel and the fact that the program has not obtained technical expertise to assess licensee compliance.
The inspection staff was unable to provide an accurate accounting of licenses that were due (or overdue) for inspection.
The inspection tracking system was last audited in October 1991.
Updates to the tracking system since then are incomplete and, in some cases, inaccurate.
The evaluation of the tracking system was complicated by the fact that numerous inspection reports were missing from the license files.
Recornendation We recommended that the State immediately obtain qualified technical support to allow the assessment of licensee co=pliance for all licenses.
We recommended that the inspection tracking system be evaluated and maintained in an accurate, updated fashion.
Current Status The two inspectors with the program at the time of the last review have received considerable amounts of training to increase their inspection skills and competence.
The training has been given by the consultant and by the RSAO.
These inspectors have performed inspections on a regular basis, and along with licensing training, have added to their knowledge and experience.
The new inspector, with a Masters degree in Health Physics, was hired to provide health physics expertise to the program.
He is currently being trained in the inspection program which includes the accompaniment of other inspectors.
A new tracking system capable of tracking inspections, licensing actions, fees, reciprocity authorizations and expirations was developed.
The system is also used to print notices, letters and reports.
An arrangement was made with the Bureau of Information Management to have a j
programmer / analyst devote approximately 80% of her time to develop the system.
The result is an excellent product which allows for better management of the program.
5 Follow-uo Recommendation f
We recommend that inspectors be provided additional training and be given the opportunity to inspect or accompany qualified inspectors for the various types of programs which are licensed in the State.
3.
Staffino Level (Catecory II Indicator)
Sicnificant Comment Comment A continuing staffing problem has existed in the Iowa radioactive materials program for years.
At the time of the 1991 follow-up review, the State had a technical staffing level of 0.76 person-year per 100 licenses.
That level was significantly less than the 1.0 to 1.5 level recommended by the NRC and was also less than the staffing level noted during the 1990 review.
As a result of the recent resignations of the two senior technical staff, the program is currently staffed by 1.75 working technical staff (junior grade) persons detailed to the program.
Considering the State's 227 licenses, the staffing level is 0.77 person-year per 100 licenses.
The lack of sufficient staff, and particularly senior staff, leaves the program in a very vulnerable position as the personnel have a heavy workload to maintain the program and are not sufficiently trained to perform basic functions such as the licensing and inspection of medical programs.
The NRC was notified by Governor Branstad's office on September 21, 1992 that two staff positions had been approved for the program.
A technical staff of 2.3 to 3.4 is required to meet the recommended staffing levels.
At least one of the technical staff hired should be an individual with considerable experience in health physics.
Pecommandation We recommended that, considering the current state of the program, that the State maintain the staffing level at the upper end of the suggested range so as to enable the program to develop beyond a borderline adequate and compatible program.
Current status The technical staffing level is currently at 3.4 FTE which is at the upper end of the suggested range as recommended by the NRC.
IDPH plans to reduce the technical staffing level to about 2.5 FTE when the licensing and inspection backlogs are completely eliminated.
The current projection for the reduction is June 1, 1993.
After that time, the workload i
vill be closely monitored by the Environmental Specialist III who, as the need arises, can request from the Bureau Chief, the detailing of the other 0.9 FTE to assist the radioactive materials program.
IDPH also projects that the
a 6
.o {
s tracking system, as it becomes more sophisticated, will further reduce the technical staff workload.
The State has informed us that since this follow-up review was conducted, the recently hired junior health physicist has submitted his resignation.
However, the State also informed us that they are taking active measures to fill this position and are currently considering several applicants.
Follow-uo Recommendation We recommend that the State maintain the radioactive materials staffing level at the upper end of the suggested a
range (i.e., 1.5 FTE per 100 licenses).
The NRC stressed in this, and in previous reviews, that a small program such as Iowa's is vulnerable to problems resulting from the loss of staff.
Pending the staff gaining considerable experience, a higher staffing ratio should be maintained.
4.
Manacement (Catecory II Indicator).
Comment supervisory review of inspection reports should be performed so that program management may ensure appropriate and consistent inspection and enforcement actions.
Eight of 26 inspection reports reviewed during the casework audit did not have approval signatures.
A similar supervisory review of complex licensing actions should be performed.
In June 1992, the University of Iowa license (Type A broad scope) was renewed and there is no evidence of a supervisory review.
Recommendation We recommended that program management perform reviews of '
all inspection reports and of significant licensing actions.
Current Status The Bureau Chief is currently reviewing and concurring on all inspection reports and license actions.
His reviews are performed after another independent review by one of the technical staff.
The NRC file audits during the last review identified numerous errors and omissions in documents which are sent to licensees.
This review by the NRC detected fewer errors but found some minor problems, such as omissions of names of persons accompanying inspectors, misspelled words, and the omission of sufficient detail on violations discussed in inspection reports.
- (
7 Follow-un Recommendation We recommend that additional efforts be made by program management to assure that inspection and licensing documentation is sound.
The recent reorganization should allow additional time to be devoted to this area.
SUMMARY
OF DISCUSSIONS WITH STATE REPRESENTATIVES Mr. Miller and Mr. Lynch presented the results of this follow-up program review to Messrs. Atchison, Fries, Flater and McGhee during a summary meeting held on February 26, 1993.
The State was informed that the radioactive materials program was improving but had not reached a point where the NRC could consider the program adequate and compatible.
The staffing situation was discussed in detail, with concerns noted by the NRC that with a proposed 2.5 FTE technical staff, the program is vulnerable and in danger of failing if one or more key personnel should leave the program.
Mr. Atchison discussed the recent reorganization which would allows the Bureau Chief more time to manage the Radioactive Materials program.
This move was applauded by the NRC as the lack of management supervision has been consistently identified as a program weakness in past reviews.
Mr. Atchison and Mr. Fries committed to the continuation of contractual support for the radioactive materials program in training and administrative areas.
The NRC committed to continue providing short-term support to the Iowa program.
These licensing and inspection training efforts will be coordinated by Mr. Lynch.
Mr. Miller suggested that a program (operating) plan might be beneficial to the Radioactive Materials program.
The plan would discuss the program's goals, strategies and priorities.
Special attention should be given to the staffing needed to accomplish each goal.
He promised to send Mr. Flater a copy of a plan in use by the NRC for guidance.
Mr. Atchison was informed that the results of the review would be reported in a letter to him from Mr. Carlton Kammerer, Director, Office of State Programs and that a written response would be requested.
i