IR 05000401/2005030

Notice of Violation from Insp on 870903.Violation Noted: Medical Isotopes Committee Did Not Meet Between 850401-0530, Failure to Maintain Written Records of Medical Isotopes Committee Meeting & Failure to Record Surveys

ML20236C068
Person / Time
Site:	Harris, 03003332
Issue date:	10/15/1987
From:	Stohr J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II)
To:
Shared Package
ML20236C065	List: IR 05000401/2005030
References
30-03332-87-01, 30-3332-87-1, NUDOCS 8710260494
Download: ML20236C068 (5)

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! ENCLOSUR NOTICE OF VIOLATION- l L

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Portsmouth General Hospital Docket No. 030-03332 Portsmouth, VA ' License No. 45-09102-02 j During the Nuclear Regulatory Commission (NRC)Linspection ; conducted on September 3, 1987, violations .of NRC ' requirements were identified; Also,.

subsequent to the inspection, information submi.tted to o'ur ' office in .a , letter ' ,

dated September 15, 1987, from J. B. Frith, Administrator, was evaluated. . The '

violations involve failure of the Medical Isotopes . Committee to ' meet ,on. a calendar quarter basis; failure to' maintain written records of Medical Isotope

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Committee meetings; failure to identify the personJperforming daily surveys'on: )

the survey record; failure to determine the geometricalcyariation of the dose ,

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calibrator; failure- to- determine the linearity of the dose calibrator on' a quarterly basis; failure to perform a weekly. wipe test'of the Nuclear Medicine Department; failure to maintain records of negative - survey .results and Lthe

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survey instrument used on a weekly basis;' failure to record daily and weekly-surveys in appropriate units; failure to record the model and. serial numbers of-

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the dose calibrator on various dose calibrator tests; . failure to conduct radiation measurements upon receipt of packages containing radioactive.-

material; failure to monitor packing material,of radioactive material shipments'

prior to discarding; and failure to record the instrur,ent and initials of I individual who performed the weekly surveys. .In accordance with the " General l Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C (1986), the violations'are listed below: ~ License Condition 17 requires the licensee to. possess; and use licensed '

material described in Items 6, 7, and 8 of this' license in accordance with statements, representations, and procedures contained in application dated May 30, 1984, and ALARA program submitted 'with application dated May' 30, 198 . Item 7 of the license application dated May '30,1984, . requires:the Medical Isotopes Committee to meet not less than once' in each calendar' quarte Contrary to the above, the Medical Isotopes Committee d'id 'not meet during the second calendar quarter of 1985 (between April l'.and -

June 30, 1985).

This is a Severity Level IV violation (' Supplement'VI). Item 7 of the license application. dated.May. 30, 1984, requires the licensee to maintain written records of all Medical Isotope Committee meeting REG 2 LIC30 PDR 45-09102-02

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Portsmouth General Hospital 2 Docket No. 030-03332 Portsmouth, VA Licenso No. 45-09102-02 Contrary to the above, the licensee did not maintain written records of a Medical Isotope Ccmmittee meeting conducted.in the third quarter of 198 This is a Severity Level V violation (Supplement VI). Item 10 of the license application dated May 30, 1984, requires the licensee to. test for geometrical variation in accordance with Appendix D, Section 2, Item F. , of the NRC Medical Licensing. Guide, unless certified data is supplied by the dose calibrator manufacturer. Appendix D, Section 2,- Item F. , of the NRC Medical Licensing Guide requires the licensee to test for geometrical i

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variation at installation, or after repair or adjustment of the dose l calibrato Contrary to the above, the licensee did not determine the geometrical variation of the Rad Cal Dose Calibrator Model- 4050 at installation, or af ter repair or adjustmen ,

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l This is a Severity Level IV violation (Supplement VI). j Item 17 of the license application dated May 30, 1984, requires

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the licensee to determine the linearity of the dose calibrator on a l quarterly basi ]

l Contrary to the above, the licensee did not determine the linearity of the Rad Cal Dose Calibrator Model 4050 between April 30, 1986 and j October 17, 1986, an interval in excess of a quarte j This is a Severity Level IV violation (Supplement VI).

.i Item 17 of the licensee application dated March 28, 1978, requires l the licensee to perform a weekly survey of the laboratory area where  !

radioactive material is used or stored. The weekly survey will j consist of a measurement of radiation levels with a survey meter and I I

a series of wipe test Contrary to the above, the licensee did not perform weekly wipe tests of the Nuclear Medicine Department between February 10, 1984 and February 24, 1984.

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

l Item 17 of the licensee application dated May 30, 1984, ' requires l l

the licensee to maintain permanent records of all weekly surveys, including negative result The record will include the type of instrument use i i

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Portsmouth General-Hospital 3 Docket No, 030-03332 Portsmouth, VA License No,' 45-09102-02 Contrary to the above, the licensee did not record on the licensee's

" Wipe Test Survey" form the negative results of weekly surveys performed on June 26, July 3, July.17, July 31, and August 17, 1987, of the Nuclear Medicine Department. Also the-licensee did not record the type of instrument used to perform the weekly . surveys of the Nuclear Medicine Department between Janucry 6,1984 and December 12, 1986, and on June 26,'198 This is a Severity Level V violation (Supplement VI). Item 17 of the license application dated May 30, 1984, requires l the licensee to record the identification of the' person performing the daily surveys.

l Contrary to the above, the licensee did not record the person performing the daily surveys of the Nuclear Medicine Department between January 2. 1987 and August 31, 198 This is a Severity Level V violation (Supplement VI). Item 17 of the license application dated May 30, 1984, requires the licensee to perform daily and weekly surveys of each area where radioactive materials are used or store The daily . surveys are performed by using a low range G-M survey meter. The weekly surveys are performed by using a survey meter and taking a series of' wipe test CFR 35.70(h) requires the licensee to retain a record of each survey for two years. The record must include the detected dose rate at several points in each area expressed in millirem per hour or the removable contamination in each area expressed in disintegrations per minute per 100 square centimeter Contrary to the above, the licensee did not record the results of daily and weekly surveys (Daily Department Survey Form: Areas 1-10)

in units of millirem per hour performed. between January 2~,1987 and August 31, 1987 in the Nuclear Medicine Department. Nor did the licensee record the results of weekly surveys (Wipe Test Survey Form) ,

l in units of disintegrations per minute per 100 square. centimeters  !

performed on June 26, July 3, and July 17, 1987.

l This is a Severity Level V violation (Supplement VI). Item 14 of the license application dated May 30, 1984 requires the licensee to measure the exposure rate at three feet from the package surface and at the package surface before opening packages containing radioactive material.

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. e (Portsmouth General Hospital ~ 4 Docket-No. 030-03332

Portsmouth, V License No. 45-09102-02.

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Contrary.to the'above, the licensee'did not measure exposure ra'tes~at.

i three feet and <at the usurface1 of. nine- (9). packages containing radioactive material . received. by the main Elaborators L between September ~19, 1985 and July. 23, 198 This is a Severity' Level IV violation'(Supplement IV).

1 Item 14 of the : license' application dated May 30, .1984 F req'uires-the licensee ~ to monitor othe packing material ~and packages;u off '

radioactive material shipments for contamination before discarding; Contrary to the. abo've, the . licensee did not monito'r the : packing a materials and packages of eighteen (18) radioactive' material-shipments, received by the ' main laboratory, before discarding. in; normal-trash disposals.between July'27, 1985 and July.28, 1987.

( This is a Severity Level.IV violation'(Supplement VI). CFR 35.50(e). requires the l licensee .to - retain a record of each dose .

( calibrator check and test. required by1this section for 'two years unless .

directed otherwise. ' The . records required in' paragraph -(b)(1) of' this

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section must. include the model'and serial numberof the dose. calibrator.

j Contrary to the above, the licensee did not record' the model and serial number of the dose calibrator-(Rad -Cal Model'4050) when performing . daily constancy checks between April 1 and September 2, 198 This is a Severity Level V violation (Supplement'VI). CFR 35.70(a) requires the licensee to survey, with a radiation detection survey instrument at the .end. of each . day of use, all areas where radiopharmaceuticals are routinely prepared for use or administratio CFR 37.70(h) requires the licensee to record the. instrument: usedito make the survey and the initials of the individual 1 who performed the I

surve Contrary to the above, the licensee did not record the instrument used to make the weekly survey nor did the ' licensee- record the initials' of the individual who performed the surveys in the main-laboratory.:between May 17-and May 29, 1987,. and between June 4 and' June 29,.198 This 'is a Severity Level V violation (Supplement VI).

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Portsmouth General Hospital 5 Docket No. 030-03332

'Portsmouth, VA License No. 45-09102-02 .;

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Pursuant to 10 CFR 2.201, Portsmouth General -Hospital is hereby required to submit to this Office within 30 days of .the date of this lette transmitting this Notice a written. statement or explanation in reply, including: (1) admission or denial of the alleged . violations;-(2) the y reasons for the violations if admitted; (3) the corrective steps which l have been taken and the results achieved; (4) corrective steps which will {

be taken to avoid further violations; and (5) the date when ful I compliance will be achieved. Where good cause is shown, consideration' :

will be given to extending the response time, FOR THE NUCLEAR REGULATORY COMMISSION I i

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. Philip tohr, Director Division of. Radiation Safety and Safeguards .

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Dated at Atlanta, Georgia this/5NdayofOctober1987 l

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