3701:1-66-11. Medical bone densitometry radiation-generating equipment

(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. part1010.2, ( as effective on the effective date of this rule), 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, the operator of bone densitometry equipment 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.

(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; and

(3) The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.

Effective: 12/20/2019
Five Year Review (FYR) Dates: 9/10/2019 and 05/01/2023
Promulgated Under: 119.03
Statutory Authority: ORC 3748.04
Rule Amplifies: ORC 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, 3748.19, 3748.20, 3748.22, 3748.99
Prior Effective Dates: 02/15/2001, 02/01/2005, 04/15/2009, 02/01/2014