TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 37. MATERNAL AND INFANT HEALTH SERVICES

The Texas Department of Health (department) adopts the repeal of §§37.21 - 37.32 and new §§37.21 - 37.39, concerning the Vision and Hearing Screening Program and the Audiometric Lab Program. New §§37.22 - 37.24, 37.26, 37.29, 37.31, and 37.34 are adopted with changes to the proposed text as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10036). The repeal of §§37.21 - 37.32 and new §§37.21, 37.25, 37.27, 37.28, 37.30, 37.32, 37.33, and 37.35 - 37.39 are adopted without changes and, therefore, the sections will not be republished.

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by the agency pursuant to the Government Code, Chapter 2001, Administrative Procedure Act. The sections have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed. However, the existing sections are repealed and new sections adopted to enhance their clarity and accessibility, and to reflect current procedures and practices.

The department published a Notice of Intention to Review for the sections as required by Government Code, §2001.039, in the Texas Register on April 28, 2000 (25 TexReg 3799). No comments were received as a result of the notice.

Specifically, the new sections concern purpose; definitions; vision and hearing screening requirements; required record of proof of screening; authorized signatures; dates for submitting proofs of screening and reports of screening results; inspection of facility screening records; transfer of individual records or proofs of screenings between facilities; standards for screening tests and screener training courses in vision and hearing; recertification of screeners; modification, suspension, or termination of screener or instructor certification; hearing screening equipment standards; scope of radiation control requirements related to audiometers, audiometric testing devices, and audiometric calibration equipment; registration of equipment and individuals using the equipment; exemptions; violations; inspections and tests; calibration of audiometers and audiometric testing devices; and audiometric calibration equipment.

New §37.21 restates the purpose of the subchapter.

New §37.22, concerning definitions, eliminates unnecessary and confusing definitions and adds new definitions that reflect current practices and procedures, including updated language regarding the type of facilities that are required to screen enrolled children for the Vision and Hearing Screening Program. New §37.22 also clarifies terms used in the regulation of hearing equipment through the Audiometric Lab Program.

New §37.23 articulates the requirements of the Vision and Hearing Screening Program, including persons who are authorized to conduct screenings, the standards for screening children, the children who must be screened, and authorized exemptions from required screening. Specifically, the schedule adopted for conducting screening examinations in §37.23(d), as amended, is consistent with the recommendations of the department's consultant. Required screening in pre-kindergarten, kindergarten, and first, third, fifth, and seventh grades reflects the importance of early detection and referral for diagnosis and treatment of vision and hearing difficulties before they adversely affect a child's ability to learn. The screening schedule also recognizes that conducting vision and hearing screening requires time and scarce resources for many facilities.

New §37.24 restates the procedures by which compliance with screening requirements may be demonstrated, including specific entries in the child's official record.

New §37.25, concerning authorized signatures, includes new language to enhance its clarity.

New §37.26, concerning due dates for submitting proof of screening and reports, simplifies the language and adds new entities required to comply with the subchapter.

New §37.27, concerning inspection of records by the department, and new §37.28, concerning transfer of individual records or proofs of screenings between facilities, now include all entities subject to this rule.

New §37.29, concerning standards for screening tests and screener training courses, clarifies the individuals who may conduct the screenings or train screeners and removes redundant language.

New §37.30, concerning termination of screener or instructor participation, includes grammatical changes.

The language of new §37.31, concerning standards for equipment, improves the clarity of the section.

Current §37.32 is repealed because the department no longer provides speech/language screenings.

New §§37.32 - 37.39 expand and clarify the provisions currently included in new §37.31, concerning the use of audiometers, audiometric testing devices, and audiometric calibration equipment monitored by the Audiometric Lab Program for compliance with radiation control requirements in Health and Safety Code, Chapter 401.

The department is making the following minor changes due to staff comments to clarify the intent and improve the accuracy of the sections.

Change: Concerning §37.22(7), the definition of "board" has been deleted. Because the phrase "this subchapter" has been substituted for "board" in §37.24(a), no definition of "board" is required. The remaining definitions have been renumbered.

Change: Concerning §37.22(12) and (24), as amended, the term "sweep check" has been changed to "sweep-check," as well as in §§37.24(a) and (b), 37.23(c)(4), and 37.29(e) for consistency throughout the subchapters.

Change: Concerning §37.22(13)(B) and (C), as amended, the Department of Family and Protective Services became operational on February 1, 2004, with a new name, and the paragraphs have been amended for consistency.

Change: Concerning §37.23(c)(3), the paragraph has been amended to clarify that children whose test results indicate failure to respond to any of the three frequencies in either ear should be rescreened not sooner than three weeks but not more than four weeks after the initial screening was performed.

Change: Concerning §37.23(c)(4), the paragraph has been amended to clarify its original intent that an extended recheck should be performed or a referral for a professional examination should be initiated for a child if test results indicate failure to respond to any of the three frequencies tested in either ear on the second sweep-check screen.

Change: Concerning §37.23(c)(6), the paragraph has been amended to clarify the procedures for conducting an extended recheck.

Change: Concerning §37.23(d), §37.23(e) as proposed has been relettered as §37.23(d), and §37.23(d) as proposed has been designated §37.23(e) to improve the clarity and logical progression of the subsection.

Change: Concerning §37.23(e)(1), as amended, the paragraph clarifies when children who enroll in a facility within 60 days of the date the facility closes for the summer must be screened.

Change: Concerning §37.23(g), the subsection has been amended to clarify that a child may be admitted to a facility on a provisional basis without having been screened at the facility, or may be denied admission until the results of a screening conducted by another person selected by the child's parent, or other person legally responsible for the child's support, is provided.

Change: Concerning §37.23(h), the subsection has been amended to correct an omission in the proposed rule, adding that screening should not take place if the child's parent or person legally responsible for the child's support submits an affidavit stating that screening conflicts with the affiant's religious principles.

Change: Concerning §37.24(a), the subsection has been amended to clarify that the standards for vision and hearing screening adopted by the Texas Board of Health are those found in this subchapter.

Change: Concerning §37.26(a), the subsection has been amended to clarify when proof of screening for children who enroll in a facility within 60 days of the date the facility closes for the summer must be submitted to the facility.

Change: Concerning §37.29(e), the subsection has been reworded to improve its readability and clarity.

Change: Concerning §37.31(a)(1), the word "using" has been deleted to correct a syntax error.

Change: Concerning §37.31(c), the subsection has been omitted because Health and Safety Code, Chapter 36, does not require that screeners and/or instructors shall receive a formal hearing before the department modifies, suspends, or terminates their certifications. Retention of access by persons who are providing this service to a formal hearing without a statutory mandate contradicts department policy.

Change: Concerning §37.34(d)(2), the requirement that registrants retain a copy of the registration form with the equipment was inadvertently omitted, and has been added.

The following comments were received concerning the proposed repeal and new sections. Following each comment is the department's response and any resulting change(s).

Comment: Concerning §37.23(b)(3) and (c)(2), one commenter stated that the new sections appear to require that vision and hearing screening results must be recorded on separate forms.

Response: The department disagrees. The rules do not require use of separate forms. Child care facilities and schools may develop their own forms for recording purposes. No changes were made as a result of this comment.

Comment: Concerning §37.23(b)(5) and (6) and §37.23(c)(4) and (5), one commenter stated that the department should assume more enforcement authority when parents ignore referrals from vision and/or hearing screeners for professional examinations.

Response: The department disagrees. The department has no statutory authority to require a parent or other person responsible for a child's welfare to act on a screener's recommendation that the child should receive a professional examination. No changes were made as a result of this comment.

Comment: Concerning §37.23(c)(2), several commenters stated that the department should continue to authorize screeners to conduct sweep-check screens at an intensity of less than or equal to 25 dB for all age/grade levels, as provided by the current rules.

Response: The department agrees and has amended the section accordingly.

Comment: Concerning §37.23(d)(1) and (2), one commenter stated that the §37.23(d)(2) should be deleted and the second sentence of §37.23(d)(1) should be amended as follows to clarify the intent of subsection (d): "If a child is enrolled within 60 days of the date a facility closes for the summer, the child's vision and hearing may be tested the following year before December 31."

Response: The department disagrees because the commenter's suggested changes would then be applied to two different populations. The second sentence of §37.23(d)(1) applies to children four years of age or older who are enrolled within 60 days of the date a facility closes for the summer, and §37.23(d)(2) applies to children who are already four years of age on September 1. No changes were made as a result of this comment.

Comment: Concerning §37.23(d)(3), one commenter suggested that the paragraph should be amended by adding a clarifying phrase such as "...in order to be exempted from that year's screening requirements."

Response: The department agrees that the circumstances under which a child whose vision and hearing has been screened in the prior reporting year may be exempted from screening should be clarified, and has amended the section accordingly.

Comment: Concerning §37.23(e), one commenter stated on behalf of other state-certified screeners that students in grade 9 should continue to be screened because that would be the last opportunity to identify vision and/or hearing deficiencies through the public health system.

Response: The department believes that most children who have vision and/or hearing problems have been identified prior to grade 9, and therefore screening in grade 9 should no longer be required. However, individual child care facilities and schools may choose to continue screening children in grade 9. No changes were made as a result of this comment.

Comment: Concerning §37.23(e), several commenters supported the department's decision to eliminate the mandatory screening requirements for children in grade 9.

Response: The department acknowledges the commenters' support. No changes were made as a result of these comments.

Comment: Concerning §37.23(e), one commenter asked, if the proposed changes are adopted, whether facilities would still be required to screen children in grade 9 for vision and hearing problems.

Response: The department confirms that adoption of §37.23(e) as proposed would eliminate the requirement for vision and hearing screening in grade 9. No changes were made as a result of this comment.

Comment: Concerning §37.23(f), one commenter stated that the subsection should be amended to clarify its meaning because schools conduct vision and hearing screening in alternate years under the current rules. The commenter also asked whether the proposed rule would authorize schools not to screen students in kindergarten because that is the only grade that has no alternative year.

Response: The department agrees that the intent of the proposed section may not have been clearly stated, and has amended the section accordingly.

Comment: Concerning §37.23(g), one commenter asked whether the subsection is intended to prevent admission of a child to a facility unless the screening is done or the affidavit is signed.

Response: According to Health and Safety Code, §36.005(c), the chief administrator of each preschool or school shall ensure that each individual admitted complies with the screening requirements in this chapter. The department believes each facility is therefore authorized to implement an admission policy/procedure that either allows only provisional admission or denies admission for each child until screening records are received by the facility. No changes were made as a result of this comment.

The department received comments on 22 issues concerning the proposed rules from six school nurses, three school district coordinators or health services, and one pediatric nurse practitioners. The comments received were generally favorable of the rules as proposed. However, many of the commenters had questions or specific concerns, and/or offered suggestions for change.

Subchapter C. SPECIAL SENSES AND COMMUNICATION DISORDERS

25 TAC §§37.21 - 37.32

The repeals are adopted under the Health and Safety Code, §36.004, which directs the Texas Board of Health (board) to require by rule screening of individuals who attend public or private preschools or schools to detect vision and hearing disorders; Health and Safety Code, §401.051, which authorizes the board to adopt rules and guidelines relating to control of sources of radiation; and §12.001, which provides the board with the authority to adopt rules for its procedure and for the performance of each duty imposed by law on the board, the department, or the commissioner of health. The review of the rules implements Government Code, §2001.039.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 2, 2004.

TRD-200402291

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 1, 2004

Proposal publication date: November 14, 2003

For further information, please call: (512) 458-7236


Subchapter C. VISION AND HEARING SCREENING

25 TAC §§37.21 - 37.39

The new sections are adopted under the Health and Safety Code, §36.004, which directs the Texas Board of Health (board) to require by rule screening of individuals who attend public or private preschools or schools to detect vision and hearing disorders; Health and Safety Code, §401.051, which authorizes the board to adopt rules and guidelines relating to control of sources of radiation; and §12.001, which provides the board with the authority to adopt rules for its procedure and for the performance of each duty imposed by law on the board, the department, or the commissioner of health. The review of the rules implements Government Code, §2001.039.

§37.22.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise:

(1) Act--The Texas Radiation Control Act, Health and Safety Code, Chapter 401.

(2) American National Standards Institute, Inc. (ANSI)--The national coordinator of voluntary standards development and the United States clearinghouse for information on national and international standards.

(3) Audiometer--An electrical device for testing hearing, and for measuring bone and air conduction of sound.

(4) Audiometric calibration equipment--Electro-acoustical equipment used to calibrate audiometers and audiometric testing devices. It also includes frequency counters, voltmeters, and distortion measuring equipment used to calibrate audiometers and audiometric testing devices.

(5) Audiometric testing device--An electro-acoustical generator that provides acoustic energy of a calibrated output.

(6) Biological calibration check--The process of testing a person having a known, stable audiometric curve that does not exceed 25 dB hearing level at any frequency between 250 and 6000 hertz, and comparing the test results with the subject's known baseline audiogram.

(7) Calibration--The process of comparing an instrument or device with a standard to determine its accuracy and to make the necessary repairs or adjustments to assure that the operating characteristics are within the allowable limits established by a national standard or the manufacturer's specifications.

(8) Certification--The process by which the Texas Department of Health trains screeners and instructors of screeners to use the currently approved screening procedure for conducting vision and hearing screening.

(9) Decibel (dB)--A unit for expressing the relative intensity of sounds on a scale from zero for the average least perceptible sound to approximately 130 for the average pain level.

(10) Department--The Texas Department of Health.

(11) Exhaustive calibration--A calibration that tests all settings for both earphones.

(12) Extended recheck--An optional screen to be used after the student has failed two sweep-check screens. The screen may be conducted immediately after the second sweep-check screen.

(13) Facility--Includes the following public, private, parochial, or denominational entities:

(A) schools;

(B) child care centers licensed by the Department of Family and Protective Services; and

(C) child care homes licensed by the Department of Family and Protective Services.

(14) Hertz (Hz)--A unit of frequency equal to one cycle per second.

(15) Licensed professional--An individual:

(A) whose legally defined scope of practice includes the area for which the screening is conducted; and

(B) who uses department-approved techniques or professional practice standards for the screening.

(16) Professional examination (also referred to as examination)--A diagnostic evaluation performed by an appropriately licensed professional or, if no license exists in this state, by a certified or sanctioned individual whose expertise addresses the diagnostic needs of the individual identified as having a possible special senses or communication disorder.

(17) Program--The Texas Department of Health's Vision and Hearing Screening Program.

(18) Radiation--One or more of the following:

(A) gamma and x rays, alpha and beta particles, and other atomic or nuclear particles or rays;

(B) stimulated emission of radiation from any electronic device to such energy density levels as to reasonably cause bodily harm; or

(C) any sonic, ultrasonic, or infrasonic waves (acoustic radiation) emitted from an electronic device or resulting from the operation of an electronic circuit in an electronic device in the energy range to reasonably cause detectable bodily harm.

(19) Reporting year--A 12-month period beginning June 1 of each year and ending May 31 of the following year.

(20) School--An educational institution that admits children who are five years of age or older but less than 21 years of age.

(21) Screeners--Licensed professionals or individuals certified by the department to conduct vision and/or hearing screening.

(22) Screening--A test or battery of tests for the determination of the need for a professional examination.

(23) Screening equipment--An instrument or device used to perform a measurement or measurements for the assessment of sensory abilities.

(24) Sweep-check hearing screening test (sweep-check)--A quick test using a pure-tone audiometer to determine whether a person can hear the following frequencies: 1000 hertz, 2000 hertz, and 4000 hertz at less than or equal to 25 decibels.

(25) Testing equipment--An instrument or device used to perform a measurement or measurements to substantiate or verify the presence or absence of sensory impairment(s).

(26) Tests--Procedures to measure special senses and communication functions.

(27) Visual acuity--The relative ability of the visual organ to resolve detail that is measured and recorded using an internationally recognized, two-figured indicator, such as 20/20.

§37.23.Vision and Hearing Screening Requirements.

(a) Screening for vision and hearing shall be performed by:

(1) a licensed professional; or

(2) an individual trained to conduct vision or hearing screening that is certified by the department.

(b) A vision screener shall use the following standards and procedures.

(1) A vision screener shall test distance acuity for both eyes with one of the following charts or a telebinocular instrument with a distance acuity test capability:

(A) Sloan Letter chart;

(B) Snellen Letter chart;

(C) Snellen "Tumbling E" chart; or

(D) HOTV Crowded Test Set.

(2) If a vision screener uses a telebinocular instrument to screen initially for distance acuity, any rescreens shall be conducted with one of the charts listed in paragraph (1) of this subsection.

(3) A vision screener shall record visual acuity results using the "20/20" format.

(4) A vision screener may use the following optional muscle-balance tests:

(A) Hirschberg corneal light reflex test; or

(B) cover and uncover test.

(5) A vision screener shall refer for professional examination all children less than five years of age whose test results indicate visual acuity of less than 20/40 in either eye or a difference of two or more lines between passing acuities in either eye.

(6) A vision screener shall refer for professional examination all children five years of age or older whose test results indicate less than 20/30 acuity in either eye.

(c) A hearing screener shall use the following standards and procedures:

(1) a pure-tone audiometer with a sweep-check screen;

(2) record screening results for both ears at less than or equal to 25 dB for 1000 Hz, 2000 Hz, and 4000 Hz;

(3) recommend or perform a rescreen with another sweep-check if test results indicate failure to respond to any of the three frequencies in either ear, no sooner than three weeks but not more than four weeks after the initial screening was performed;

(4) recommend or perform an extended recheck or initiate a referral for a professional examination for all children whose test results indicate failure to respond to any of the three frequencies in either ear on the second sweep-check;

(5) recommend a professional examination if the extended recheck results in a failure to respond to any frequency; and

(6) conduct an extended recheck according to the following procedures.

(A) Beginning with the right ear, present the tone at 40 dB hearing level (HL) and at 1000 Hz for two to three seconds. If no response is obtained, record " > 40 dB".

(B) If the child responds at 40 dB, lower the intensity to 30 dB HL and present the tone again.

(C) Lower the HL in 10 dB increments until no response is obtained, or until 20 dB is reached. If a response is obtained at 20 dB, record "20 dB".

(D) When no response is obtained, increase the HL dial in 5 dB increments until a response is obtained. Record the dB results obtained at 1000 Hz for the right ear.

(E) Repeat steps in subparagraphs (A) - (D) of this paragraph at 40 dB HL for 2000 Hz and 4000 Hz.

(F) Repeat steps in subparagraphs (A) - (E) of this paragraph for the left ear.

(d) All children enrolled in a facility shall be screened for vision and hearing problems in pre-kindergarten, kindergarten, first, third, fifth, and seventh grades before May 31 of each year.

(e) All children enrolled in a facility must be screened according to the following schedule.

(1) Children four years of age or older, who are enrolled in any facility for the first time, must be screened for possible vision and hearing problems within 120 calendar days of enrollment. If a child is enrolled within 60 days of the date a facility closes for the summer, the child's vision and hearing must be tested by December 31 of that year.

(2) Children previously enrolled in a facility who are four years of age on or before September 1, must be screened for possible vision and hearing problems by December 31.

(3) Except for children enrolled in kindergarten or first grade, a facility shall exempt any child from screening as required by subsection (d) of this section if the child's parent or legal guardian submits proof to the facility that the child's vision and/or hearing has been screened within the prior reporting year.

(f) Upon written request approved by the department, the screening of vision and hearing in a school may occur in pre-kindergarten, kindergarten, and first, second, fourth, and sixth grades instead of pre-kindergarten, kindergarten, and first, third, fifth, and seventh grades.

(g) The parent(s), guardian(s), managing conservator(s), or person(s) having legal responsibility for the child's support may execute an affidavit stating that a person other than the screener used by the facility shall conduct the screening as soon as is feasible. The child may be admitted into the facility on a provisional basis, or the child may be denied admission, until the screening results are provided to the facility.

(h) A facility shall not require a child to be screened if the parent(s), guardian(s), managing conservator(s), or person(s) having a legal responsibility for the child's support submits to the facility, on or before the date vision or hearing screening is scheduled, an affidavit in lieu of the record of screening stating that the vision or hearing screening conflicts with the tenets or practices of a church or religious denomination of which the affiant is an adherent or member.

§37.24.Required Record of Proof of Screening.

(a) A facility may comply with §37.23 of this title (relating to Vision and Hearing Screening Requirements) by including a statement in the child's official facility record that the child has undergone screening tests that meet the standards set by this subchapter and were administered by persons authorized to sign the required proof of screening. The statement shall include the child's visual acuity, sweep-check results, and any other screening results.

(b) A facility also may comply with §37.23 of this title by including in the child's official facility record documentation of the child's visual acuity, sweep-check results, and any other screening results from vision and hearing screens performed within the immediately preceding year.

§37.26.Dates for Submitting Proofs of Screening and Reports of Screening Results.

(a) Proof of vision and hearing screening must be submitted to a facility no later than 120 calendar days after the date of the child's initial enrollment. If a child is enrolled within 60 days of the date a facility is scheduled to close for the summer, the child's proof of vision and hearing screening must be submitted to the facility by December 31 of that year.

(b) Proof of vision and hearing screening must be submitted to a facility for all other children by May 31.

(c) On or before June 30 of each year, each facility shall submit to the department a report on the screening status of its aggregate population screened during the reporting year.

(1) The results of required professional examinations or screening tests shall be reported by each facility as specified on a form(s) approved by the department.

(2) The department may revise vision and hearing screening forms as necessary.

§37.29.Standards for Screening Tests and Screener Training Courses in Vision and Hearing.

(a) The basic screening tests and referral criteria shall be approved by the department and incorporated into the screener training manuals provided by the department.

(b) Screeners shall utilize the basic screening tests and referral criteria.

(c) Individuals who have completed high school and who have successfully completed the department's vision or hearing screening course are eligible to be certified as screeners.

(d) Department staff or department-approved instructors of screening shall issue a certificate to individuals who successfully complete the department's vision or hearing screening course. Certified screeners may screen children for vision or hearing problems for a period of five years.

(e) Persons other than licensed professionals who conduct hearing screening as authorized by Health and Safety Code, Chapter 36, shall utilize only the sweep-check and extended recheck techniques and shall refer children unable to respond reliably to these screening techniques to an appropriately licensed professional for further evaluation.

(f) Certified screeners may utilize only individuals who have completed high school as volunteer assistants.

(g) Individuals other than department personnel eligible to become instructors in hearing screening techniques must have experience as a screener, must have experience conducting workshops, and must have successfully completed any department-required training course.

(h) Individuals other than department personnel eligible to become instructors in vision screening techniques must have experience as a screener, must have experience conducting workshops, and must have successfully completed any department-required training course.

(i) Individuals other than department personnel who are certified as instructors may maintain their certification by successfully completing each updated continuing education course provided by the department upon notification of its availability.

(j) All training sessions for screeners must be approved by the department at least 15 working days prior to the training sessions.

§37.31.Modification, Suspension, or Termination of Screener or Instructor Certification.

(a) Certification of a screener may be modified, suspended, or terminated for the following reasons:

(1) repeated failure to conduct screens according to procedures and referral criteria approved by the department;

(2) repeated failure to report screening results according to the department's standards;

(3) making repeated referrals for professional examinations that indicate a conflict of interest; or

(4) repeated violations of the Family Educational Rights and Privacy Act of 1974, 20 United States Code §1232g, et seq.

(b) Certification of an instructor may be modified, suspended, or terminated on the following grounds:

(1) repeated failure to conduct training workshops for screeners utilizing the curriculum and/or procedures approved by the department;

(2) repeated failure to notify the department at least 15 working days prior to a scheduled workshop; or

(3) repeated failure to participate in the continuing education courses provided by the department.

§37.34.Registration of Equipment and Individuals Using the Equipment.

(a) Registration is required for:

(1) audiometers, audiometric testing devices and audiometric calibration equipment, unless exempted by subsection (c) of this section; and

(2) individuals who possess and use audiometers, audiometric testing devices, and audiometric calibration equipment.

(b) As part of the registration process, individuals must also:

(1) be trained by or undergo training approved by the department in the proper use of this equipment; and

(2) file reports as required by the department.

(c) Registration is not required for:

(1) agencies of the United States government;

(2) equipment owned by agencies of the United States government;

(3) 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

(4) equipment intended exclusively for nonhuman use.

(d) Registration of nonexempt audiometers, audiometric testing devices and audiometric calibration equipment shall include the following procedures.

(1) Each person having possession of or using audiometers, audiometric testing devices, or audiometric calibration equipment not exempted by these regulations shall register such equipment within 30 days following the commencement of an activity involving the operation of an audiometer, audiometric testing device, or audiometric calibration equipment.

(2) Each registrant shall complete and file a current department form, and shall retain a copy of the form with the equipment.

(3) Each registrant shall notify the department within 30 days of any change in the information required in paragraph (1) of this subsection.

(4) The department shall terminate a registration upon notification from the registrant that the registered audiometer, audiometric testing device, or audiometric calibration equipment has been transferred to another person or destroyed.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on April 2, 2004.

TRD-200402292

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 1, 2004

Proposal publication date: November 14, 2003

For further information, please call: (512) 458-7236