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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 157.59 General 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 157.61 Administrative 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.
DHS 157.61(1)(c) (c) For up to 60 days each year, a licensee may permit an authorized user or 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). 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 an 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.
DHS 157.61(3)(a)2. 2. Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, requirements of this chapter and license conditions regarding the medical use of radioactive material.
DHS 157.61(3)(b) (b) A licensee who permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user shall do all of the following:
DHS 157.61(3)(b)1. 1. Instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material.
DHS 157.61(3)(b)2. 2. Require the supervised person to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, the written radiation protection procedures established by the licensee and the regulations of this chapter, and license conditions.
DHS 157.61(3)(c) (c) A licensee who permits supervised activities under pars. (a) and (b) is responsible for the acts and omissions of the supervised individual.
DHS 157.61(4) (4)Written directives.
DHS 157.61(4)(a)1.1. A written directive must be dated and signed by an authorized user prior to administration of I-131 sodium iodide greater than 1.11 Megabequerels (30 microcuries), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material.
DHS 157.61(4)(a)2. 2. If, because of the emergent nature of the patient's condition, a delay in providing a written directive would jeopardize the patient's health, an oral directive from an authorized user is acceptable provided the information contained in the oral directive is documented immediately in writing in the patient's record and a written directive is prepared within 48 hours of the oral directive.
DHS 157.61(4)(a)3. 3. A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the dosage of radioactive drug containing radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose or the next fractional dose.
DHS 157.61(4)(a)4. 4. If, because of the patient's condition, a delay to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision.
DHS 157.61(4)(b) (b) The written directive shall contain the patient or human research subject's name and all of the following information:
DHS 157.61(4)(b)1. 1. For the administration of a dosage of a radioactive drug, the name, dosage and administration route of the radioactive drug.
DHS 157.61(4)(b)2. 2. For each anatomically distinct treatment site exposed to gamma stereotactic radiosurgery, total dose, treatment site and number of target settings per treatment.
DHS 157.61(4)(b)3. 3. For teletherapy, the total dose, dose per fraction, number of fractions, treatment site and overall treatment period.
DHS 157.61(4)(b)4. 4. For high dose rate remote afterloading brachytherapy, the radionuclide, treatment site, dose per fraction, number of fractions and total dose.
DHS 157.61(4)(b)5. 5. For all other brachytherapy including low dose rate, medium dose rate and pulsed dose rate afterloading, both of the following:
DHS 157.61(4)(b)5.a. a. Prior to implantation, treatment site, the radionuclide and dose.
DHS 157.61(4)(b)5.b. b. After temporary implantation, but prior to completion of the procedure, the radioisotope, treatment site, number of sources, and total source strength and exposure time or, instead of total source strength and exposure time, the total dose.
DHS 157.61(4)(b)5.c. c. For permanent implantation, the radioisotope, treatment site, number of sources, total source strength, total dose and method of implantation.
DHS 157.61(4)(c) (c) A licensee shall retain the written directive under s. DHS 157.71 (3).
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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.