Rules went into effect August 1, 2004
Texas Health and Safety Code, Chapter 36
VISION AND HEARING SCREENING PROGRAM and AUDIOMETRIC LABORATORY
Department of State Health Services
Vision and Hearing Screening
1100 West 49th Street
Austin, Texas 78756-3199
Relay Texas: Dial 7-1-1
Title 25. Health Services
Part 1. Department of State Health Services
Chapter 37. Maternal and Infant Health Services
Subchapter C. Vision and Hearing Screening
§§37.21-37.39 §37.21. Purpose. The purpose of these rules is to implement Health and Safety Code, Chapter 36, concerning the early identification of individuals from birth through 20 years of age who have special senses and communication disorders and who need remedial vision, hearing, speech, or language services. The rules also implement Health and Safety Code, Chapter 401, concerning radioactive materials and other sources of radiation by providing guidance for the safe and effective use of audiometers, audiometric testing devices, and audiometric calibration equipment.
§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 Department of State Health Servicestrains 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 Department of State Health Services.
- (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 Department of State Health Services 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.
(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.
- (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.
§37.24. Required Record of Proof of Screening.
§37.25. Authorized Signatures.
- (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) The required proof of vision screening may be signed by a licensed professional whose licensure qualifies him or her to evaluate visual acuity if he or she performed the vision examinations or personally supervised the screening tests.
- (b) The required proof of hearing screening may be signed by a licensed professional whose licensure qualifies him or her to evaluate hearing acuity if he or she performed the hearing examinations or personally supervised the screening tests.
- (c) The required proofs of vision and hearing screening may also be signed by designated personnel certified as screeners under §37.29 of this title (relating to Standards for Screening Tests and Screener Training Courses in Vision and Hearing).
§37.27. Inspection of Facility Screening Records.
- (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.
As authorized by Health and Safety Code, Chapter 36, department personnel may enter a facility and inspect screening records maintained by the facility. The department also may authorize local health department personnel to enter a facility and inspect records maintained by the facility. §37.28. Transfer of Individual Records or Proofs of Screenings Between Facilities.
§37.29. Standards for Screening Tests and Screener Training Courses in Vision and Hearing.
- (a) A facility shall honor an original or true copy of the proofs of screening upon the transfer of a student from another Texas facility.
- (b) When a facility's official record for a child contains entries of vision or hearing examinations or screening test results, the original or true and correct copy of the record may be transferred between facilities.
§37.30. Recertification of Screeners.
- (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) A screener certified by the department may renew his or her certification by attending a department-approved training course prior to December 31 of the fifth year of certification.
- (b) A certified screener who fails to attend the recertification training course before December 31 of the fifth year of certification must attend the basic certification training course.
§37.32. Hearing Screening Equipment Standards.
- (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.
(l) A calibration firm found to be in noncompliance with the requirements in subsection (k) of this section shall:
- (a) All audiometers, audiometric testing devices, and audiometric calibration equipment shall meet the appropriate current American National Standards Institute (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, or as otherwise approved by the department.
- (b) Equipment found to be defective upon inspection by department personnel or which constitutes an emergency as a threat to the public health or safety will be tagged with a "DO NOT USE" tag. Tagged equipment may not be used until repaired and recalibrated by a registered repair and calibration firm, and must be repaired and recalibrated within 30 days after being tagged. Only registered firms may remove the tag, and must forward the tag along with a copy of the calibration form to the department. The owner of equipment tagged "DO NOT USE" under an emergency order may request a hearing, which will be conducted in accordance with §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).
- (c) Each individual using audiometric screening or testing equipment, as well as the equipment, must be registered with the department in accordance with the Act.
- (d) Each individual using audiometric screening or testing equipment shall afford the department, at all reasonable times, opportunity to inspect each installation or use of the equipment.
- (e) Upon reasonable notice, each individual using audiometric screening or testing equipment shall make available to the department records maintained pursuant to this subchapter.
- (f) Upon instruction from the department, each individual using audiometric screening or testing equipment shall perform, or shall permit the department to perform such tests as are necessary to assure compliance with this subchapter.
- (g) Each individual using audiometric screening or testing equipment shall perform a biological calibration on the equipment during each month of use.
- (h) All audiometric screening or testing equipment shall comply with calibration requirements in §37.38 of this title (relating to Calibration of Audiometers and Audiometric Testing Devices).
- (i) Only calibration firms registered with the department shall perform periodic electronic calibrations and exhaustive electronic calibrations, and the audiometric equipment shall bear dated decals or stickers as evidence of the calibrations.
- (j) The department shall base registration of calibration firms upon their ability to perform audiometric repairs and/or calibrations consistent with appropriate current ANSI standards or the manufacturer's specifications if no ANSI standards apply, and shall follow department-approved procedures.
- (k) In addition to complying with §289.3 of this title (relating to the Control of Infrasonic, Sonic, and Ultrasonic Radiation), calibration firms shall:
(1) register with the department;
- (2) maintain calibration equipment within manufacturer's allowable limits;
- (3) calibrate their own audiometric calibration equipment annually;
- (4) maintain a staff of technicians who are trained in repairs and calibrations meeting appropriate ANSI standards, or the manufacturer's specifications if no ANSI standards apply, and who follow department-approved procedures; and
- (5) maintain and calibrate audiometric equipment so that among a minimum of 25 units of the equipment checked by department staff prior to use by the owners of the equipment, no more than 15% fail to meet standards.
- (1) be subject to the penalties as set out in the Act and in §289.3 of this title;
- (2) receive notice of noncompliance the first time the calibration firm commits a violation; and
- (3) be subject to registration revocation by the department for repeated noncompliance or failure to correct a violation(s) and shall not be eligible for reinstatement for a period of one year.
(m) Before the department revokes registration of a calibration firm, the department shall provide the calibration firm the opportunity for a hearing in accordance with §§1.21, 1.23, 1.25, and 1.27 of this title. (n) The calibration firm's registration may be reinstated after one year upon application to the department and demonstration of satisfactory performance in the interim according to the applicable requirements in this subchapter.
§37.33. Scope of Radiation Control Requirements Related to Audiometers, Audiometric Testing Devices, and Audiometric Calibration Equipment. Except as otherwise specifically provided, the sections in this subchapter apply to:
§37.34. Registration of Equipment and Individuals Using the Equipment.
- (1) all persons who receive, possess, acquire, transfer, own, or use audiometers, audiometric testing devices, and audiometric calibration equipment; and
- (2) all audiometers used for audiometric screening and hearing threshold tests, audiometric testing devices, and audiometric calibration equipment used in the State of Texas.
(b) As part of the registration process, individuals must also:
- (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.
(c) Registration is not required for:
- (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.
(d) Registration of nonexempt audiometers, audiometric testing devices and audiometric calibration equipment shall include the following procedures.
- (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.
- (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.
The department may, upon application by persons or upon its own initiative, grant such exemptions or exceptions from the department's requirements for such periods of time as it determines are authorized by law and will not result in undue hazard to public health and safety, or property. §37.36. Violations.
The department may seek an injunction or other court order prohibiting a violation of the Act, or any rules adopted pursuant to the Act. A person who violates the Act also may be guilty of a misdemeanor and shall, upon conviction, be subject to fine or imprisonment, as provided by law. §37.37. Inspections and Tests.
§37.38. Calibration of Audiometers and Audiometric Testing Devices.
- (a) Each registrant shall afford the department at all reasonable times opportunity to inspect each installation of an audiometer, audiometric testing device, or audiometric calibration equipment.
- (b) Each registrant shall make available to the department for inspection, upon reasonable notice, records maintained pursuant to this subchapter.
- (c) Each registrant shall perform, upon instructions from the department, or shall permit the department to perform, such reasonable tests as the department deems appropriate or necessary to assure compliance with the requirements of this subchapter.
- (a) Audiometers and audiometric testing devices shall be maintained in calibration to meet the required standard(s) by use of the following procedures.
- (1) A biological calibration shall be performed at least once each month when the audiometer is in use.
- (2) A calibration shall be performed at least annually or if the results of the biological calibration indicate:
- (A) hearing level differences greater than 5 dB at any frequency;
- (B) the signal is distorted; or
- (C) there are attenuator or tone switch transients.
- (3) An exhaustive electronic calibration shall be performed at least every five years.
- (b) Calibration records and monthly biological calibration data for audiometers or audiometric testing devices shall be maintained for inspection by the department for three years.
§37.39. Audiometric Calibration Equipment.
- (a) The accuracy of the calibration equipment shall be sufficient to prove that each audiometer or audiometric testing device calibrated is within the tolerances permitted by current ANSI standards.
- (b) Calibration forms and records for audiometers or audiometric testing devices, as well as audiometric standards calibration records shall be maintained for inspection by the department for three years.