25 Tex. Admin. Code § 37.28 - Hearing Screening Equipment Standards and Requirements

(a) Except as otherwise specifically provided, the sections in this subchapter apply to all persons and entities (e.g., calibration companies, facilities) who receive, possess, acquire, transfer, own, or use audiometers, audiometric testing devices, and audiometric calibration equipment, and to all audiometers used for audiometric screening and hearing threshold tests, all audiometric testing devices, and all audiometric calibration equipment used in the State of Texas.

(b) Each individual and entity using any of the equipment referenced in subsection (a) of this section must be registered with the department, in the manner prescribed by the department (see information at http://www.dshs.state.tx.us/vhs/audio.shtm). Registration information must be updated in a timely manner to keep it current.

(c) Equipment referenced in subsection (a) of this section shall meet the appropriate current ANSI standards, or the manufacturer's specifications if no ANSI standards apply, and all other applicable federal and state standard(s) and/or regulation(s) for such equipment.

(d) Individuals must be trained by or undergo training approved by the department in the proper use of this equipment, as detailed in § 37.27 of this title (relating to Standards and Requirements for Screening Certification and Instructor Training).

(e) Individuals and entities who perform calibration services on the equipment referenced in subsection (a) of this section shall register with the department, and must update that registration in a timely manner to keep it current, in a manner prescribed by the department (see information at http://www.dshs.state.tx.us/vhs/audio.shtm).

(f) Only calibration firms shall perform periodic electronic calibrations and exhaustive electronic calibrations. Calibration firms shall provide notification to the owner of the audiometer being calibrated that the audiometer has been calibrated. The notification may be in the form of a decal or sticker affixed to the audiometer, or in hard copy documentation that must be maintained by the owner and be made readily available to the department or its representative upon request.

(g) Upon reasonable notice, each individual or entity using audiometric screening equipment shall make available to the department, in a timely manner, records maintained pursuant to this subchapter. Calibration forms and records for all equipment referenced in subsection (a) of this section, including monthly biological calibration data, shall be maintained for inspection by the department for three years.

(h) Registration is not required for:

(1) equipment in storage, being shipped, or being offered for sale, if the audiometer, audiometric testing devices, and audiometric calibration equipment is not being used; and

(2) equipment limited to nonhuman use.

Notes

25 Tex. Admin. Code § 37.28

The provisions of this §37.28 adopted to be effective August 17, 2014, 39 TexReg 6055