19 CSR 40-9.020 - Screening Methodologies and Procedures

PURPOSE: This rule establishes the screening methodologies and procedures that a facility, audiologist, and/or other person that performs hearing screenings outside of a facility must use to operate a newborn hearing screening program and/or perform diagnostic audiological assessments.

(1) Each facility shall designate a person responsible for carrying out the newborn hearing screening program at their facility, referred to as the program manager.

(2) By February 1, 2002, each facility shall notify the department, electronically or in writing, of the name, business address and telephone number of the program manager. Changes to the facility's program manager and/or changes in the business contact information shall be reported to the department within thirty (30) calendar days.

(3) Each facility operating a newborn hearing screening program shall establish written policies and procedures. These policies and procedures shall include, but are not limited to:

(A) The type of newborn hearing screening program (one or two stage) to be operated;

(B) The type of Food and Drug Administration (FDA)-approved hearing screening equipment being used, and screening methods, including the facility location(s) where the screenings will be completed;

(C) Specific duties for all persons participating in the newborn hearing screening program, including minimum training/experience requirements for persons performing the screenings;

(D) A written plan for initial training for all persons participating in the newborn hearing screening program;

(E) A method of evaluating and documenting the competency of each newborn hearing screener's performance upon completion of the initial training and at least annually thereafter;

(F) A plan for ensuring accuracy of newborn hearing screening results. The plan shall address the importance of attaining and maintaining acceptable referral rates;

(G) A plan to notify the parent(s) and primary care provider of the hearing screening results;

(H) Designation of facility personnel responsible for reporting newborn hearing screening results to the department;

(I) Distribution of the prescreening pamphlet to all families of newborns;

(J) Distribution of the audiologist resource guide;

(K) A method of referral for newborns who "missed" the birth admission hearing screening, or require rescreening and/or diagnostic audiological assessment; and

(L) Documentation of screenings refused by the family.

(4) A facility using non-audiologic personnel to perform the newborn hearing screening shall use FDA-approved screening equipment that provides automated pass/refer criteria.

(5) A facility shall provide to the department or department-designee, a copy of their written policies and procedures upon request.

(6) The facility shall provide each newborn's parent(s) with information about newborn hearing screening in English or other language or alternate method as appropriate. The department shall provide information to facilities in other languages upon request.

(7) A facility or person(s) performing hearing screenings outside a facility shall notify parent(s) and the primary care provider of the hearing screening results within seven (7) calendar days of the screening.

(8) A facility or person that performs a hearing screening outside a facility, shall give the parent(s) of a newborn receiving unilateral or bilateral "refer" result(s), a list (developed by the department) of audiological services. Parent(s) shall be instructed to contact the primary care provider and any third-party payers to determine the appropriate referral process prior to obtaining audiological services.

(9) Rescreening shall be performed by an audiologist, physician, and/or facility personnel trained in the newborn hearing screening program.

(10) Rescreening shall be completed within thirty (30) calendar days of the initial newborn hearing screening. Infants requiring continuous acute care following birth shall have their rescreening completed within thirty (30) calendar days of the acute care discharge.

(11) Diagnostic audiological assessments shall be performed by audiologists.

(12) Diagnostic audiological assessments shall be completed within thirty (30) calendar days of the rescreening, or initial screening if applicable. Infants requiring continuous acute care following birth shall have their diagnostic audiological assessment completed within three (3) months of the acute care discharge.

(13) The audiologist shall notify the parent(s) and primary care provider of the diagnostic audiological assessment results no later than seven (7) calendar days following the completion of the assessment.

(14) The department shall make reasonable efforts to assure that all newborns have a hearing screening by three (3) months of age (or within three (3) months of discharge from an acute facility for infants requiring continuous acute care following birth).

(15) The department shall make reasonable efforts to assure that all newborns with a confirmed hearing loss are referred to the appropriate point of contact for the Part C of the Individuals with Disabilities Education Act (IDEA) system of early intervention services (First Steps) by six (6) months of age (or within six (6) months of discharge from an acute care facility for infants requiring continuous acute care following birth).

Notes

19 CSR 40-9.020

AUTHORITY: section 191.937, RSMo 2000.* Original rule filed Aug. 1, 2001, effective Jan. 31, 2002. Amended: Filed Jan. 31, 2003, effective July 30, 2003.

*Original authority: 191.937, RSMo 1999.