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DHS 157.55(2)(f) (f) Records of quarterly inventories under s. DHS 157.52 (8).
DHS 157.55(2)(g) (g) Utilization records under s. DHS 157.52 (9).
DHS 157.55(2)(h) (h) Records of inspection and maintenance under s. DHS 157.52 (12).
DHS 157.55(2)(i) (i) Survey records under sub. (1).
DHS 157.55(2)(j) (j) Training records under s. DHS 157.53 (1).
DHS 157.55(3) (3) Documents and records required at temporary job sites. A licensee or registrant conducting operations at a temporary jobsite shall have all the following documents and records available at the temporary jobsite for inspection by the department:
DHS 157.55(3)(a) (a) Operating and emergency procedures.
DHS 157.55(3)(b) (b) Survey records required under sub. (1) for the period of operation at the jobsite.
DHS 157.55(3)(c) (c) Evidence of current calibration for the radiation survey instruments in use at the jobsite.
DHS 157.55(3)(d) (d) During operation in the state under reciprocity, a copy of the appropriate license, certificate of registration or equivalent documents.
DHS 157.55(3)(e) (e) Shipping papers for the transportation of radioactive material.
DHS 157.55 History History: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 06-021: am. (1) (d) Register October 2006 No. 610, eff. 11-1-06.
DHS 157.56 DHS 157.56Notification of incidents, abandonment and lost sources.
DHS 157.56(1)(1)Provisions. Notification of incidents, and sources of radiation lost in other than well logging operations, shall be made under appropriate provisions of subch. III.
DHS 157.56(2) (2) Initial actions. Whenever a sealed source or device containing radioactive material is lodged in the well-bore or may have ruptured and caused contamination, a licensee shall do all the following:
DHS 157.56(2)(a) (a) Monitor at the surface for the presence of radioactive contamination with a radiation survey instrument or well logging tool during recovery operations.
DHS 157.56(2)(b) (b) Notify the department immediately by telephone and subsequently, within 30 days, by confirmatory letter if the licensee knows or has reason to believe that a sealed source has been ruptured. The confirmatory letter shall identify the well or other location, describe the magnitude and extent of the escape of radioactive material, assess the consequences of the rupture and explain efforts planned or being taken to mitigate these consequences.
DHS 157.56 Note Note: The department may be contacted at: 608-267-4797 during normal business hours of 7:45 am to 4:30 pm, Monday through Friday, except state holidays, and other times at 608-258-0099.
DHS 157.56(3) (3) Unsuccessful recovery. When it becomes apparent that efforts to recover the radioactive source will not be successful, a licensee shall do all the following within 30 days of making the determination that source recovery is not possible or request an extension from the department:
DHS 157.56(3)(a) (a) Advise the well operator of the requirements contained in this section and an appropriate method of abandonment, which shall include all the following:
DHS 157.56(3)(a)1. 1. Immobilization and sealing in place of the radioactive source with a cement plug.
DHS 157.56(3)(a)2. 2. Setting of a deflection device.
DHS 157.56(3)(a)3. 3. Mounting of a permanent identification plaque at the surface of the well, containing the information required by sub. (4).
DHS 157.56(3)(b) (b) Notify the department by telephone within 24 hours, giving the circumstances of the loss and request approval of the proposed abandonment procedures.
DHS 157.56(3)(c) (c) File a written report with the department within 30 working days of the abandonment. A licensee shall send a copy of the report to the department of natural resources bureau that issued permits or otherwise approved of the drilling operation. The report shall contain all the following information:
DHS 157.56(3)(c)1. 1. Date of occurrence.
DHS 157.56(3)(c)2. 2. A description of the well logging source involved, including the radionuclide and its quantity, chemical and physical form.
DHS 157.56(3)(c)3. 3. Surface location and identification of the well.
DHS 157.56(3)(c)4. 4. Results of efforts to immobilize and seal the source in place.
DHS 157.56(3)(c)5. 5. A brief description of the attempted recovery effort.
DHS 157.56(3)(c)6. 6. Depth of the source.
DHS 157.56(3)(c)7. 7. Depth of the top of the cement plug.
DHS 157.56(3)(c)8. 8. Depth of the well.
DHS 157.56(3)(c)9. 9. Any other information, such as a warning statement, contained on the permanent identification plaque.
DHS 157.56(3)(c)10. 10. The names of state agencies receiving a copy of the report.
DHS 157.56 Note Note: Written reports and requests for extensions may be mailed to the department at the following address: Department of Health Services, Radiation Protection Section, PO Box 2659, Madison, WI, 53701-2659. The telephone contact number is: 608-267-4797 during normal business hours and 608-258-0099 after hours.
DHS 157.56(4) (4) Posting. Whenever a sealed source containing radioactive material is abandoned in a well a licensee shall post a permanent plaque, as described in ch. DHS 157 Appendix K, at the surface of the well. The plaque shall be constructed of long-lasting material, such as stainless steel or monel, and contain all the following information engraved on its face:
DHS 157.56(4)(a) (a) The word “CAUTION".
DHS 157.56(4)(b) (b) The radiation symbol without the conventional color requirement.
DHS 157.56(4)(c) (c) The date of abandonment.
DHS 157.56(4)(d) (d) The name of the well operator or well owner.
DHS 157.56(4)(e) (e) The well name and well identification number or numbers or other designation.
DHS 157.56(4)(f) (f) The sealed source or sources by radionuclide and activity.
DHS 157.56(4)(g) (g) The source depth and the depth to the top of the plug.
DHS 157.56(4)(h) (h) An appropriate warning, depending on the specific circumstances of each abandonment.
DHS 157.56 Note Note: Appropriate warnings may include: (a) “Do not drill below plug-back depth;" (b) “Do not enlarge casing;" or (c) “Do not re-enter the hole," followed by the words, “before contacting the Department of Health Services, Radiation Protection Section".
DHS 157.56(5) (5) Loss in potable fresh water aquifer. A licensee shall immediately notify the department by telephone and within 24 hours by confirming letter if the licensee knows or has reason to believe that radioactive material has been lost in or to an underground potable fresh water aquifer. The notice shall designate the well location, describe the magnitude and extent of loss of radioactive material, assess the consequences of such loss and explain efforts planned or being taken to mitigate these consequences.
DHS 157.56 Note Note: The department may be contacted at: Department of Health Family Services, Radiation Protection Section, P.O. Box 2659, Madison, WI, 53701-2659. Telephone contact is: 608-267-4797 during normal business hours or 608-258-0099 after hours.
DHS 157.56 History History: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 06-021: am. (4) (intro.) and (5) Register October 2006 No. 610, eff. 11-1-06; correction in (4) (intro.) made under s. 35.17, Stats., Register January 2018 No. 745.
subch. VI of ch. DHS 157 Subchapter VI — Medical Use of Radioactive Material
DHS 157.59 DHS 157.59General requirements.
DHS 157.59(1)(1)Maintenance of records. A record required by this subchapter shall be legible throughout the specified retention period. The record may be the original, a reproduced copy or a microform, provided the copy or microform is authenticated by authorized personnel and the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored electronically with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings and specifications, shall include all pertinent information such as stamps, initials and signatures. A licensee shall maintain adequate safeguards against tampering with and loss of records.
DHS 157.59(2) (2) Provisions for research involving human subjects. A licensee may conduct research involving human subjects using radioactive material provided all of the following requirements are met:
DHS 157.59(2)(a) (a) A licensee shall apply for and receive approval of a specific amendment to its radioactive materials license before conducting the research. A licensee shall obtain informed consent from the human subjects and obtain prior review and approval of the research activities by an “Institutional Review Board" or equivalent under the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.
DHS 157.59 Note Note: The definition and responsibilities of an Institutional Review Board are described on 45 CFR Part 46 which may be downloaded from the following website: http://www.access.gpo.gov/nara/cfr/waisidx_00/45cfr46_00.html.
DHS 157.59(2)(b) (b) The research involving human subjects authorized in par. (a) shall be conducted using radioactive material authorized for medical use in the license.
DHS 157.59(2)(c) (c) Nothing in this subsection relieves a licensee from complying with the other requirements in this subchapter or from complying with applicable FDA or other federal requirements governing radioactive drugs or devices.
DHS 157.59(3) (3) Implementation.
DHS 157.59(3)(a)(a) If the requirements of this subchapter are more restrictive than the existing license condition, a licensee shall comply with this subchapter unless exempted by par. (c).
DHS 157.59(3)(b) (b) Any existing license condition that is not affected by a requirement in this subchapter remains in effect until there is a license amendment or license renewal.
DHS 157.59(3)(c) (c) If a license condition exempted a licensee from a provision of this subchapter on the effective date of August 1, 2002, the exemption shall continue until the department amends, suspends or revokes the license.
DHS 157.59(3)(d) (d) If a license condition cites provisions in this subchapter that are later deleted, the license condition remains in effect until a license amendment or renewal modifies or removes the license condition.
DHS 157.59 History History: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter.
DHS 157.61 DHS 157.61Administrative requirements.
DHS 157.61(1)(1)Authority and responsibilities for the radiation protection program.
DHS 157.61(1)(a)(a) In addition to the radiation protection program requirements of s. DHS 157.21, a licensee's management shall approve in writing any of the following:
DHS 157.61(1)(a)1. 1. A request for license application, renewal or amendment before submittal to the department.
DHS 157.61(1)(a)2. 2. Authorization prior to using licensed materials for any individual to work as an authorized user, authorized nuclear pharmacist or authorized medical physicist.
DHS 157.61(1)(a)3. 3. A radiation protection program change that does not require a license amendment and is permitted under sub. (2).
DHS 157.61(1)(b) (b) A licensee's management shall appoint a radiation safety officer who agrees in writing to be responsible for implementing the radiation protection program. A licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed under licensee-approved procedures and regulatory requirements. A licensee's management may appoint, in writing, one or more associate radiation safety officers to support the radiation safety officer. The radiation safety officer, with written agreement of the licensee's management, must assign the specific duties and tasks to each associate radiation safety officer. These duties and tasks are restricted to the types of use for which the associate radiation safety officer is listed on a license. The radiation safety officer may delegate duties and tasks to the associate radiation safety officer but shall not delegate the authority or responsibilities for implementing the radiation protection program.
DHS 157.61(1)(c) (c) For up to 60 days each year, a licensee may permit an individual qualified to be a radiation safety officer to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer, as provided in par. (f), provided the licensee takes the actions required in pars. (b), (d), (f), and (g) and notifies the department in accordance with s. DHS 157.13 (5) (c) 2. e. A licensee may simultaneously appoint more than one temporary radiation safety officer if needed to ensure that the licensee has a temporary radiation safety officer that satisfies the requirements to be a radiation safety officer for each of the different uses of radioactive material permitted by the license.
DHS 157.61(1)(d) (d) A licensee shall establish in writing the authority, duties and responsibilities of the radiation safety officer.
DHS 157.61(1)(e) (e) A licensee that is authorized for 2 or more different types of uses of radioactive material under ss. DHS 157.64, 157.65 and 157.67 or 2 or more types of units under s. DHS 157.67 shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license. The committee shall include an authorized user of each type of use permitted by the license, the radiation safety officer, a representative of the nursing service and a representative of management who is neither an authorized user nor a radiation safety officer, and may include other members as the licensee deems appropriate.
DHS 157.61(1)(f) (f) A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources and management prerogative to perform all the following functions:
DHS 157.61(1)(f)1. 1. Identify radiation safety problems.
DHS 157.61(1)(f)2. 2. Initiate, recommend or provide corrective actions.
DHS 157.61(1)(f)3. 3. Stop unsafe operations.
DHS 157.61(1)(f)4. 4. Verify implementation of corrective actions.
DHS 157.61(1)(g) (g) A licensee shall retain a record of actions taken under pars. (a), (b) and (d) according to the record retention requirements of s. DHS 157.71 (1).
DHS 157.61(2) (2) Radiation protection program changes.
DHS 157.61(2)(a) (a) A licensee may revise its radiation protection program without department approval if the revision meets all the following criteria:
DHS 157.61(2)(a)1. 1. The revision does not require a license amendment.
DHS 157.61(2)(a)2. 2. The revision complies with the requirements of this chapter and the license.
DHS 157.61(2)(a)3. 3. The revision has been reviewed and approved by the radiation safety officer and licensee management.
DHS 157.61(2)(a)4. 4. The affected individuals are instructed on the revised program before the changes are implemented.
DHS 157.61(2)(b) (b) A licensee shall retain a record of each change under s. DHS 157.71 (2).
DHS 157.61(3) (3) Supervision.
DHS 157.61(3)(a)(a) A licensee who permits the receipt, possession, use or transfer of radioactive material by an individual under the supervision of an authorized user shall do all the following:
DHS 157.61(3)(a)1. 1. Instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, requirements of this chapter and license conditions regarding the use of radioactive material.
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.