No. 43472 (Amendment): Rule R398-5. Birth Defects Reporting

(Amendment)

DAR File No.: 43472
Filed: 01/10/2019 10:14:44 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The reason for these changes is to update wording to more accurately establish the Critical Congenital Heart Disease (CCHD) reporting requirements, and to update and add reportable birth defect diagnosis codes including Zika Virus, Cytomegalovirus, hearing loss, and neonatal withdrawal symptoms.

Summary of the rule or change:

These changes update wording to more accurately establish the CCHD reporting requirements, and update and add reportable birth defect diagnosis codes including Zika Virus, Cytomegalovirus, hearing loss, and neonatal withdrawal symptoms.

Statutory or constitutional authorization for this rule:

• Subsection 26-1-30(5)
• Subsection 26-10-1(2)
• Subsection 26-1-30(6)
• Subsection 26-1-30(7)
• Subsection 26-1-30(9)
• Subsection 26-1-30(18)
• Subsection 26-1-30(22)

Anticipated cost or savings to:

the state budget:

May have a minimal cost if reprinting of rule is needed.

local governments:

No cost to local governments as the reporting requirements has been standard practice for the past several years.

small businesses:

No cost to small businesses as the reporting requirements has been standard practice for the past several years.

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

No cost to businesses, individuals, local governments, and persons that are not small businesses as the reporting requirements has been standard practice for the past several years.

Compliance costs for affected persons:

No costs for affected persons as the reporting requirements has been standard practice for the past several years.

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

There are no costs to business because the reporting requirements have been standard practice for the past several years.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office 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:

• Joyce McStotts at the above address, by phone at 801-584-8239, by FAX at 801-584-8488, 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:

03/04/2019

This rule may become effective on:

03/11/2019

Authorized by:

Joseph Miner, Executive Director

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs

FY 2019

FY 2020

FY 2021

State Government

$0

$0

$0

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$0

$0

$0

Other Person

$0

$0

$0

Total Fiscal Costs:

$0

$0

$0

Fiscal Benefits

State Government

$0

$0

$0

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$0

$0

$0

Other Persons

$0

$0

$0

Total Fiscal Benefits:

$0

$0

$0

Net Fiscal Benefits:

$0

$0

$0

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non-Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non-Small Businesses

These rule changes update terminology, create consistency within CCHD reporting, diagnosis codes and reporting timelines.

 

These rule changes are not expected to have any fiscal impact on hospitals, clinics, alternate birthing facility, midwifes, or primary care providers as this has been the standard of practice for the past several years. These rule changes will update terminology to be consistent with reporting requirements, create consistency with word usage, update diagnosis codes, and update reporting timelines.

 

The Executive Director of Department of health, Joseph Miner, MD, has reviewed and approved this fiscal analysis.

 

 

R398. Health, Family Health and Preparedness, Children with Special Health Care Needs.

R398-5. Birth Defects and Critical Congenital Heart Disease 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(5), (6), (7), (9), (18), (22), 26-10-1(2), 26-10-2, and 26-10-6(1)(d) authorize this rule.]

R398-5-1. Authority and Purpose.

(1) This rule is authorized by sections 26-1-30(5), (6), (7), (9), (18), (22), 26-10-1(2), 26-10-2, and 26-10-6(1)(d).

(2) This rule establishes reporting requirements for birth defects, critical congenital heart disease, and stillbirths in Utah and for related test results.

 

R398-5-2. Definitions.

As used in this rule:

[(2)](1) "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, from 740.0 to 759.9[;], 760.72,[and] from 768.0 to 768.9[;], and 779.5 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: A92.5, E03, E25, from E70 to E90, from D55 to D58, H90.0 to H90.8, H90.A, H91.0 to H91.9, J96.00 to J96.91, P09, P35.1, P35.4, P96.1 to P96.2 and from Q00[-] to Q99.

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

(3) "CCHD" means Critical Congenital Heart Disease.

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

(5) "Critical Congenital Heart Disease (CCHD) Screening" is a non-invasive test using pulse oximetry measuring how much oxygen is in the blood and can help to identify newborns affected with CCHD. Screening should begin after 24 hours of age or shortly before discharge if the baby is less than 24 hours of age.

(6) "Department" means the Utah Department of Health, Utah Birth Defect Network and Critical Congenital Heart Disease programs.

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

(8) "Institution" means a hospital, alternate birthing facility, or midwife service providing maternity or nursery services or both.

(9) "SpO2" stands for peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood.

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

 

R398-5-3. [Reporting by Hospitals and Birthing Centers.]Birth Defects Reporting.

Each hospital, clinic, institution, or birthing center [that]which 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;

(a) last name;

(b first name;

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

(3) child's medical record number;

[(9)](4) child's [sex]gender;[and]

[(3)](5) mother's name;

(a) last name;

(b) first name;

(c) maiden name;

[(4)](6) mother's date of birth;

(7) mother's medical record number;

[(5)](8) delivery [hospital]institution;

[(6)](9) ICD - 9 - CM or ICD - 10 birth defect[s] codes[and hypoxia/hypoxemia diagnoses];

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

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

[(10)](11) mother's zip code of residency at delivery.

 

R398-5-4. Birth Defects Reporting by Laboratories.

Each laboratory operating in the state [that]which 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];

(a) last name;

(b) first name;

(2) child's date of birth;

[(2)](3) mother's name;

(a) last name;

(b) first name;

[(3)](4) mother's date of birth;

[(4)](5) date the sample is accepted by the laboratory;

[(5)](6) test conducted;

[(6)](7) test result; and

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

 

R398-5-5. Critical Congenital Heart Disease (CCHD) Screening Reporting.

CCHD Screening results shall report or cause to report to the department within 40 days of discharge the following:

(1) newborn's name;

(a) last name;

(b) first name;

(2) newborn's date of birth;

(3) newborn's gender;

(4) newborn's gestational age;

(5) newborn's birth weight;

(6) newborn's medical record number;

(7) newborn's newborn screening kit number;

(8) newborn's delivery institution;

(9) newborn's discharge unit (if applicable);

(10) newborn's CCHD Screening result for each attempt:

(a) date;

(b) time;

(c) probe location;

(d) SpO2 result; and

(e) outcome of attempt.

(11) Newborn's first echocardiogram (if indicated):

(a) date; and

(b) time.

(12) mother's name;

(a) last name;

(b) first name;

(c) maiden name;

(13) mother's date of birth; and

(14) mother's medical record number.

 

R398-5-[5]6. Record Abstraction.

Hospitals, birthing centers, institutions, 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]this and other pregnancies [by that]of the mother. Hospitals, birthing centers, institutions, 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]7. 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]8. 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.

 

KEY: birth defects, birth defect reporting , critical congenital heart disease (CCHD), CCHD screening

Date of Enactment or Last Substantive Amendment: [July 31, 2012]2019

Notice of Continuation: September 2, 2014

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

---