3701:1-66-11 Bone densitometry radiation-generating equipment.

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.

Effective: 02/01/2014
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