RMB - Regulations Governing Class VI, VII & IX Consultants


Regulations Governing Registered Experts and Health Physics Consultants
.0205	.0213	.0214	Return to Consultant "Home Page"

Applicable Regulations
.0205 APPLICATION FOR REGISTRATION OF SERVICES
(a)	Each person who is engaged in the business of installing or offering to install radiation machines and machine components or is engaged in the business of furnishing or offering to furnish any equipment services listed in Paragraph (d) of this Rule in this state, to any agency licensee or registrant, shall apply for registration of such services with the agency prior to furnishing or offering to furnish any of these services.
(b)	Application for registration shall be completed on appropriate form(s) provided by the agency and shall contain all information required by the agency as indicated on the form and accompanying instructions. This information shall include:
	(1)	the name, address and telephone number of:
		(A)	the individual or the company to be registered;
		(B)	the owner(s) of the company;
	(2)	the description of the services to be provided;
	(3)	the name, training and experience of each person who provides services specified in Paragraph (d) of this Rule;
	(4)	the date of the application and the signature of the person responsible for the company; and
	(5)	any additional information the agency determines to be necessary for evaluation of the application for registration.
(c)	Each person applying for registration under Paragraph (a) of this Rule shall certify that he has read and understands the requirements of the rules in this Chapter.
(d)	For the purpose of this Section, equipment services include:
	(1)	direct sale and transfer of radiation machines and machine components to end users;
	(2)	installation or servicing of radiation machines and associated radiation machine components;
	(3)	diagnostic radiographic facility and shielding design;
	(4)	diagnostic fluoroscopic facility and shielding design;
	(5)	diagnostic area radiation survey, e.g., shielding evaluation;
	(6)	radiation instrument calibration;
	(7)	therapeutic facility and shielding design, area radiation survey or calibration;
	(8)	personnel dosimetry services; and
	(9)	general health physics consulting, e.g., independent diagnostic radiation output measurements, dose analysis, design of safety programs and radiation safety training programs, non-healing arts facility and shielding design and area radiation surveys.
(e)	Applicants for registration of services are subject to the applicable requirements of Rules .0213 and .0214 of this Section.
History Note:			Authority G.S. 104E-7; Eff. February 1, 1980; Amended Eff. June 1, 1993; May 1, 1992; June 1, 1989.
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.0213 ADDITIONAL REQUIREMENTS: REGISTERED SERVICES
(a)	An applicant for registration of diagnostic area radiation survey, diagnostic radiation output measurements or therapeutic calibration services pursuant to Rule .0205 of this Section shall meet the following additional requirements:
	(1)	The applicant shall have adequate radiation survey and radiation measurement equipment appropriate to the services requested for authorization.
	(2)	The applicant shall ensure that the equipment in Subparagraph (a)(1) of this Rule is calibrated at least every 12 months by persons registered to provide such services pursuant to Rule .0205 of this Section, except as provided in Subparagraph (a)(3) of this Rule. The agency may approve less frequent calibration of equipment used for therapy calibration, provided the applicant satisfies the agency that the proposed frequency and procedures will provide equivalent or better assurance of proper calibration.
	(3)	The applicant may perform the equipment calibrations required in Subparagraph (a)(2) of this Rule provided that:
		(A)	such calibrations are currently traceable to the National Institute of Standards and Technology;
		(B)	the calibration procedures are approved by the agency;
		(C)	the radiation sources used for such calibration are licensed or registered as required by the rules in this Chapter; and
		(D)	the equipment is labeled to indicate the date of calibration and records of the calibration are maintained.
	(4)	The applicant shall submit:
		(A)	a description of the procedures that will be used in performing area radiation surveys including a list of all guides and references to the employed;
		(B)	a copy of all forms, reports and documents that will be supplied to customers;
		(C)	samples of three different types of surveys;
		(D)	samples of three reports of diagnostic radiation output measurements; and
		(E)	samples of three therapeutic calibration reports.
(b)	An applicant for registration of services pursuant to Rule .0205 of this Section who proposes to provide diagnostic radiographic, fluoroscopic and therapeutic facility and shielding design services shall meet the following additional requirements:
	(1)	The applicant shall submit examples of the facility and shielding design which will be provided to clients.
	(2)	The applicant shall submit examples of the calculations which will be performed as part of the facility and shielding design along with any guides, occupancy factor rationales, and workload estimation rationales which will be used.
	(3)	The applicant shall ensure that the facility and shielding design services provided to licensees and registrants of the agency satisfy the applicable requirements in this Chapter.
History Note:			Authority G.S. 104E-7; Eff. June 1, 1989; Amended Eff. June 1, 1993
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.0214 TRAINING AND EDUCATIONAL REQUIREMENTS FOR EQUIPMENT SERVICES
(a)	Each person registered pursuant to Rule .0205 of this Section shall be qualified by reason of education, training and experience to provide the services for which registration is requested. The following are minimum qualifications for specific types of services:
	(1)	Class I - sales of radiation machines and machine components to end users: The applicant must certify knowledge of familiarity with the rules which govern the possession, installation and use of radiation machines in North Carolina.
	(2)	Class II - installation and service of radiation machines and machine components including the making of diagnostic radiation output measurements to verify performance associated with the installation or service:
		(A)	manufacturer's equipment school for service, maintenance and installation for the type of machine use (e.g. dental intraoral, medical diagnostic or medical fluoroscopic) or equivalent training;
		(B)	training in principles of radiation protection; and
		(C)	three months of experience in installation and service of radiation machines and machine components.
	(3)	Class III - diagnostic radiographic facility and shielding design:
		(A)	training in principles of radiation protection;
		(B)	training in shielding design; and
		(C)	one year of experience in diagnostic radiographic facility and shielding design for the specific type of machine application.
	(4)	Class IV - diagnostic fluoroscopic facility and shielding design:
		(A)	training in principles of radiation protection;
		(B)	training in shielding design; and
		(C)	one year of experience in diagnostic fluoroscopic facility and shielding design for the specific type of machine application.
	(5)	Class V - diagnostic area radiation survey, e.g., shielding evaluation:
		(A)	training in basic radiological health;
		(B)	training in shielding evaluation; and
		(C)	one year of experience performing area radiation surveys.
	(6)	Class VI - radiation instrument calibration: The applicant must possess a current radioactive materials license or registration authorizing radiation instrument calibration.
	(7)	Class VII - therapeutic facility and shielding design, area radiation survey, or calibration:
		(A)	certification by the American Board of Radiology in therapeutic radiological physics, radiological physics, roentgen-ray and gamma ray physics, or x-ray and radium physics; or certification by the American Board of Medical Physics; or
		(B)	having the following minimum training and experience:
			(i)	a master's degree in physics, biophysics, radiological physics or health physics;
			(ii)	one year of full-time training in therapeutic radiological physics
			(iii)	one year of full-time experience in a therapeutic facility including personal calibration and spot-check of at least one machine;
		(C)	shall submit a description of the procedures that will be utilized in performing therapeutic calibrations including a list of all guides and references to be employed;
		(D)	shall submit a copy of all forms, reports and documents that will be supplied to customers; and
		(E)	shall submit one sample of each specific type, e.g., teletherapy, accelerator.
	(8)	Class VIII - personnel dosimetry service: The applicant must hold current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology or use NVLAP accredited dosimetry.
	(9)	Class IX - general health physics consulting, e.g., independent diagnostic radiation output measurements, dose analysis, design of safety programs, and radiation safety training programs, non-healing arts facility and shielding design, and area radiation surveys:
		(A)	baccalaureate degree in a physical science (e.g. physics, chemistry or radiologic science), engineering or related field and two years of progressive experience in medical or health physics; graduate training in medical or health physics may be substituted on a year for year basis; or
		(B)	certification by the American Board of Radiology in therapeutic radiological physics, radiological physics, roentgen-ray and gamma ray physics, or x-ray and radium physics; certification by the American Board of Health Physics in health physics or certification by the American Board of Medical Physics.
(b)	Any person not meeting the requirements in Paragraph (a) of this Rule may apply to the agency for registration, provided such person demonstrates education, training and experience which is equivalent to that required in Paragraph (a) of this Rule.
(c)	Any person registered prior to the effective date of this Rule to provide equipment services pursuant to Rule .0205 of this Section shall meet the education, training and experience requirements in Paragraph (a) or (b) of this Rule no later than 24 months after the effective date of this Rule.
(d)	The agency shall initiate action to terminate the registration of any person who fails to comply with the requirements of Paragraph (c) of this Rule.
History Note:			Authority G.S. 104E-7; 104E-13; Eff. June 1, 1989; Amended Eff. June 1, 1993

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