Health, Family Health and Preparedness, Children with Special Health Care Needs

Rule R398-5

Birth Defects Reporting

Notice of Proposed Rule

(Amendment)

DAR File No.: 36109
Filed: 04/30/2012 09:08:08 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The changes, mostly additions, in Sections R398-5 and R398-5-3 would allow for additional information to be sent to the Utah Birth Defect Network (UBDN) to improve identification and monitoring of congenital heart defects. The addition under Section R398-5-5 is somewhat broader as it pertains to all of the identified birth defects collected and would greatly improve the potential to address the issues of transition into young adulthood, an area which is a large and growing problem. Lastly the removal of an obsolete reference to criminal penalties for violating a rule that is no longer supported by statutory delegation of this authority by the Legislature (see H.B. 32, 2009 General Session).

Summary of the rule or change:

The changes add language to the rule that will allow for additional information to be sent to the UBDN to better monitor congenital heart defects; and add language which will allow the UBDN to address issues of quality of life for those identified with a birth defect. A reference to criminal penalties for violating this rule is removed.

State statutory or constitutional authorization for this rule:

• Subsection 26-10-1(d)
• Subsections 26-1-30(2)(c), (d), (e), (g), (p), (t)

Anticipated cost or savings to:

the state budget:

It is possible that increased focus on use of civil money penalties could have a positive impact on the state's budget, but any impact is expected to be minimal.

local governments:

This rule does not affect local governments because they do not report birth defects to the Department of Health. Therefore, this change has no fiscal impact on them.

small businesses:

The Division is unaware of any small businesses that may be affected by this rule amendment, although in the unlikely event that there is a birthing center that qualifies as a small business the impact of these changes would only require that a few additional fields be added to the current monthly report that they would already be reporting. Therefore, no fiscal impact is anticipated for these groups.

persons other than small businesses, businesses, or local governmental entities:

This rule amendment imposes no new costs on businesses, individuals, local governments, or persons that are not small businesses. These facilities already send monthly reports to the UBDN and this amendment would only require that a few additional fields be added to the current report. Therefore, no fiscal impact is anticipated for these groups.

Compliance costs for affected persons:

It is possible that increased focus on use of civil money penalties could have a minimal impact on small and large business. No significant change to current enforcement practices is predicted and compliance costs are not expected to change.

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

Regulated entities have been consulted on this rule change. This additional data will serve an important public health function and their support for the rule change is expected. Fiscal impact is expected to be minimal.

David Patton, PhD, Executive Director

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

Health
Family Health and Preparedness, Children with Special Health Care Needs
44 N MARIO CAPECCHI DR
SALT LAKE CITY, UT 84113

Direct questions regarding this rule to:

• Amy Nance at the above address, by phone at 801-883-4661, by FAX at 801-323-1578, or by Internet E-mail at [email protected]

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:

06/14/2012

This rule may become effective on:

06/22/2012

Authorized by:

David Patton, Executive Director

R398. Health, Family Health and Preparedness, 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 in Utah and for 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 any medical disorder of organ structure, function or biochemistry which is of possible genetic or prenatal origin. This includes any congenital anomaly , indication of hypoxia 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[,]; and from 768.0 to 768.9; 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, J96.00 to J96.91, P09, 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 or screens for 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 and hypoxia/hypoxemia diagnoses;

(7) pulse oximetry results for all initial and repeat screenings, including limb location;

([7]8) mother's state of residency at delivery;

([8]9) child's sex; and

([9]10) mother's zip code.

 

R398-5-4. Reporting by Laboratories.

Each laboratory operating in the state that identifies a human chromosomal or genetic abnormality or other evidence of a birth defect shall report the following on a calendar quarterly basis to the department within 40 days of the end of the preceding calendar quarter:

(1) if live born, child's name and date of birth;

(2) mother's name;

(3) mother's date of birth;

(4) date the sample is accepted by the laboratory;

(5) test conducted;

(6) test result; and

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

 

R398-5-5. Record Abstraction.

Hospitals, birthing centers, and clinics as well as community health care providers 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 and postnatal procedures or treatments (including diagnostics) related to the birth defect or stillbirth, and outcomes of that and other pregnancies by that mother. Hospitals, birthing centers, and clinics as well as community health care providers shall allow personnel from the department or its contractors to abstract information from the affected child's files, throughout their lifespan.

 

R398-5-6. Liability.

As provided in Title 26, Chapter 25, persons who report, either voluntarily or as required by this rule, information covered by this rule may not be held liable for reporting the information to the Department of Health.

 

R398-5-7. Penalties.

Pursuant to Section 26-23-6, any person that willfully violates any provision of this rule may be assessed an administrative civil money penalty not to exceed $1,000 upon an administrative finding of a first violation and up to $3,000 for a subsequent similar violation within two years. A person may also be subject to penalties imposed by a civil or criminal court .[, which may not exceed $5,000 or a class B misdemeanor for the first violation and a class A misdemeanor for any subsequent similar violation within two years.]

 

KEY: birth defects, birth defect reporting

Date of Enactment or Last Substantive Amendment: [July 3, 2008]2012

Notice of Continuation: September 28, 2009

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