No. 31070 (Amendment): R398-5. Birth Defects Reporting

DAR File No.: 31070
Filed: 03/21/2008, 12:15
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of the proposed rule change is to expand the birth defect reporting rule to allow the Utah Birth Defect Network (UBDN) to collect information on stillbirths and genetic metabolic disorders. Adding these conditions, for which there is no current population-based surveillance mechanism, will allow the UBDN to track prevalence rates over time, assess and identify maternal risk factors, as well as design and evaluate prevention activities. The proposed change also strengthens the language regarding community health care providers and clinics as the UBDN has had trouble securing prenatal records from these sources. The prenatal records provide key information regarding potential risk factors, as well as diagnostic methods and timing.

Summary of the rule or change:

This rule change expands the definition of "birth defect" to include genetic metabolic disorders and adds stillbirth as a reportable condition. This change also strengthens the language regarding community health care providers and clinics allowing UBDN staff to abstract information from the prenatal records of mothers of affected children.

State statutory or constitutional authorization for this rule:

Subsections 26-1-30(2)(c), (d), (e), (g), (p), (t), and 26-10-1(2), and Sections 26-10-2 and 26-25-1

Anticipated cost or savings to:

the state budget:

The proposed changes would slightly increase the workload of existing UBDN staff. This slight increase in workload would not warrant additional FTEs. Any increase in cost could be absorbed in the current UBDN budget allocation.

local governments:

The proposed changes would only affect those local governments that operate hospitals. Under the proposed changes, hospitals would be required to slightly modify their current birth defect report to include still births. Under the current rule, hospitals are required to allow UBDN staff to abstract the medical records of affected children and their mothers. This would not change. However, the number of records requested would increase slightly. The UBDN anticipates that these changes would add an additional 300 new cases per year state-wide. According to a survey of 8 hospitals, it costs approximately $1.10 to pull each record for UBDN review, meaning the total cost for all local government-operated hospitals is less than $40 annually.

small businesses and persons other than businesses:

There are only three types of people or businesses in this category that would be affected by the proposed changes. They are birthing centers with less than 50 employees, medical practices with less than 50 employees, and private health care providers not practicing in a group or clinic. The birthing centers would be affected in the same manner as the hospitals as documented above with an estimated cost of less than $10 per year per facility (a maximum aggregate cost of $20 statewide as there are only 2 birthing centers licensed in the state). The only medical practices or private care providers that would be affected are those providing obstetrical care. It is current standard of practice for an obstetric care provider to send a copy of the prenatal record to the hospital where their patients will deliver. Information within the prenatal record is vital to birth defect surveillance. Therefore, if the prenatal record is not found in the medical record at the delivery hospital, then the UBDN accesses those records through the obstetrical care provider. Each year approximately 300 of the birth hospital records reviewed by the UBDN do not contain the prenatal records. Maintaining the estimate of $1.10 to access a record, the aggregate cost of reviewing these records would be $330. Combined with the cost for the birthing centers, the total aggregate cost to small businesses and persons other than businesses would be $350.

Compliance costs for affected persons:

Compliance costs for affected persons, as detailed above, are estimated to be less than $10 per affected person per year.

Comments by the department head on the fiscal impact the rule may have on businesses:

A very minor cost to business is expected, while the benefit of gathering this information is important to public health. David N. Sundwall, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Community and Family Health Services, Children with Special Health Care Needs
44 N MEDICAL DR
SALT LAKE CITY UT 84113

Direct questions regarding this rule to:

Lyle Odendahl at the above address, by phone at 801-538-6878, by FAX at 801-538-6306, or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

05/15/2008

This rule may become effective on:

05/22/2008

Authorized by:

David N. Sundwall, Executive Director

RULE TEXT

R398. Health, Community and Family Health Services, Children with Special Health Care Needs.

R398-5. Birth Defects Reporting.

R398-5-1. Purpose and Authority.

This rule establishes reporting requirements for birth defects and stillbirths[for births] in Utah and for [birth-defect ]related test results. Sections 26-1-30(2)(c), (d), (e), (g), (p), (t), 26-10-1(2), and 26-10-2 authorize this rule.

 

R398-5-2. Definitions.

As used in this rule:

(1) "Birthing center" means a birthing center licensed under Title 26, Chapter 21.

(2) "Birth defect" means [a]any medical disorder of organ structure, function or biochemistry which is of possible genetic or prenatal origin. This includes any congenital anomaly or genetic metabolic disorder listed in the ICD-9-CM (International Classification of Diseases, 9th Revision, Clinical Modification, established by the United States Center for Health Statistics) with any of the following diagnostic codes: 243, 255.2, 255.4, from 269.2 to 279.9, and from 740.0 to 759.9; or listed in the ICD-10 (International Classification of Diseases, 10th Revision, established by the World Health Organization) with any of the following diagnostic codes: E03, E25, from E70 to E90, from D55 to D58, and from Q00-Q99.

(3) "Hospital" means general acute hospital, children's specialty hospital, remote-rural hospital licensed under Title 26, Chapter 21.

(4) "Stillbirth" means a pregnancy resulting in a fetal death at 20 weeks gestation or later.

(5) "Clinic" means physician-owned or operated clinic that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services.

 

R398-5-3. Reporting by Hospitals and Birthing Centers.

Each hospital or birthing center that admits a patient and detects a birth defect as a result of any outcome of pregnancy, or admits a child under 24 months of age with a birth defect, or is presented with the event of a stillbirth shall report or cause to report to the department within 40 days of discharge the following:

(1) if live born, child's name;

(2) child's date of birth (or date of delivery);

(3) mother's name;

(4) mother's date of birth;

(5) delivery hospital;

(6) birth defects diagnoses;

(7) mother's state of residency at delivery;

(8) child's sex; and

(9) mother's zip code.

 

R398-5-5. Record Abstraction.

Hospitals, [and ]birthing centers, and clinics [required to report pursuant to this rule ]as well as community health care providers [who participate voluntarily ]shall allow personnel from the department or its contractors to abstract information from the mother's and child's files on their demographic characteristics, family history of birth defects, prenatal [information]and postnatal procedures or treatments (including diagnostics) related to the birth defect or stillbirth, and outcomes of that and other pregnancies by that mother.

 

KEY: birth defects, birth defect reporting

Date of Enactment or Last Substantive Amendment: [September 17, 2002]2008

Notice of Continuation: September 22, 2004

Authorizing, and Implemented or Interpreted Law: 26-1-30(2)(c), (d), (e), (g), (p), (t); 26-10-1(2); 26-10-2; 26-25-1