For the purposes of this rule, "bone densitometry equipment" means radiation-generating equipment intended for the medical purpose of quantifying bone density and mineral content by x-ray measurements through the bone and adjacent tissues. In addition to the applicable rules in Chapters 3701:1-38 and 3701:1-66 of the Administrative Code, handlers of bone densitometry equipment shall comply with the following:
(A) Handlers of bone densitometry equipment shall assure that the equipment is certified by the manufacturer in accordance with the requirements of 21 C.F.R. 1010.2, as published in the April 1, 2012, Code of Federal Regulations, and maintained in accordance with the manufacturer's specifications.
(B) In addition to other applicable radiation safety requirements in Chapters 3701:1-38 and 3701:1-66 of the Administrative Code, handlers of bone densitometry equipment shall comply with the following:
(1) The operator shall be positioned at least one meter ( 3.3 feet) from the primary beam or behind a protective barrier containing a minimum of 0.25 millimeter of lead equivalent materials.
(2) Operators of bone densitometry equipment shall possess an Ohio radiologic license in accordance with rules in Chapter 3701-72 of the Administrative Code.
(C) In addition to other applicable quality assurance requirements in rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, handlers of bone densitometry equipment shall comply with the following:
(1) The quality assurance program shall include quality control test records which shall be maintained between inspections and shall include the following:
(a) A list of the tests to be performed as specified by the manufacturer;
(b) The frequency of performance as specified by the manufacturer;
(c) The acceptability limits for each test as specified by the manufacturer; and
(d) A brief description of the procedures and test equipment to be used for each test.
(2) Maintain a readily available copy of the manufacturer's operating manual.
(3) The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.
Cite as Ohio Admin. Code 3701:1-66-11
R.C. 119.032 review dates: 10/09/2013 and 02/01/2019
Promulgated Under: 119.03
Statutory Authority: 3748.04
Rule Amplifies: 3748.01, 3748.02, 3748.04 , 3748.05, 3748.06, 3748.07, 3748.12, 3748.121, 3748.13, 3748.14, 3748.15, 3748.17, 3748.18, 3748.20, 3748.22, 3748.99
Prior Effective Dates: 2/15/2001, 2/1/05, 4/15/09