DAR File No. 38802

This rule was published in the January 1, 2015, issue (Vol. 2015, No. 1) of the Utah State Bulletin.


Health, Family Health and Preparedness, Maternal and Child Health

Rule R433-1

Very Low Birth Weight Infant Reporting

Change in Proposed Rule

DAR File No.: 38802
Filed: 12/11/2014 12:37:52 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this change is to fine tune required morbidities to be reported since the original rule filing.

Summary of the rule or change:

Neonatologist stakeholders requested that the division delete the following morbidities required by the rule: PDA, Late Bacterial Infection and organism, Ventilator associated pneumonia and organism, any late bacterial infection and organism and Central line Infection and organism. All of these various infections will be captured in the Nosocomial Infection and organism. They also requested that the site for the Nosocomial Infection be added to differentiate. Lastly, they also requested the division add the Major Birth Defect and type. (DAR NOTE: This change in proposed rule has been filed to make additional changes to a proposed new rule that was published in the September 15, 2014, issue of the Utah State Bulletin, on page 20. Underlining in the rule below indicates text that has been added since the publication of the proposed rule mentioned above; strike-out indicates text that has been deleted. You must view the change in proposed rule and the proposed new rule together to understand all of the changes that will be enforceable should the agency make this rule effective.)

State statutory or constitutional authorization for this rule:

  • Subsections 26-1-30(2)(c), (d), (e), and (p)
  • Subsections 26-10-1(a) and (b)

Anticipated cost or savings to:

the state budget:

No difference from the original proposed new rule.

local governments:

No difference from the original proposed new rule.

small businesses:

No difference from the original proposed new rule.

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

No difference from the original proposed new rule.

Compliance costs for affected persons:

No difference from the original proposed new rule.

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

No difference from the original proposed new rule. These changes are for clarification.

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, Maternal and Child Health
,

Direct questions regarding this rule to:

  • Lois Bloebaum at the above address, by phone at 801-538-6792, by FAX at , or by Internet E-mail at lbloebaum@utah.gov

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:

02/02/2015

This rule may become effective on:

02/12/2015

Authorized by:

Lois Bloebaum, Executive Director

RULE TEXT

R433. Health, Family Health and Preparedness, Maternal and Child Health.

R433-1. Very Low Birth Weight Infant Reporting.

R433-1-1. Purpose and Authority.

This rule establishes reporting and records access requirements for certain morbidities of Very Low Birth Weight infants. It establishes reporting of newborn care capabilities by Utah hospitals. Sections 26-1-30 (2)(b), (c), (d), (e), and (p) provide authority for this rule.

 

R433-1-2. Definitions.

As used in this rule:

(1) "Very Low Birth Weight" (VLBW) means the birth weight of an infant born weighing greater than 400 grams and less than 1500 grams.

(2) "Neonatal Intensive Care Unit" (NICU) is a designated unit within a hospital, which specializes in the care of ill or premature newborn infants.

(3) "Nursery" means a designated unit within a hospital, which unit specializes in the care of newborn infants.

(4) "Health care provider" means an individual or group of individuals who provide care for women and/or infants during the prenatal, perinatal and/or neonatal period.

(5) "Vermont Oxford Network" (VON) is a non-profit voluntary collaboration of health care professionals dedicated to improving the quality and safety of medical care for newborn infants and their families.

(6) "Hospital" is a general acute hospital licensed under Title 26, Chapter 21 that cares for a VLBW infant.

(7) "Department" means Utah Department of Health (UDOH), UDOH employed staff, or UDOH designated contractor.

(8) "Major morbidities" include: Chronic Lung Disease, [Late Bacterial Infection and organism, ]Nosocomial Infection and organism and site, [Any Late Infection and organism, ]Grade III or IV Intraventricular Hemorrhage, Cystic Periventricular Leukomalacia, Grade III, IV or V Retinopathy of Prematurity (ROP), ROP surgery, Avastin following ROP surgery, Necrotizing Enterocolitis, [Patent Ductus Arteriosis (PDA)]Patent Ductus Arteriosis (PDA) surgery, PDA [surgery]medication, Major Birth Defect and type[and Central Line infection and organism], [Ventilator associated pneumonia and organism, ]all as defined by the Vermont Oxford Network 2014 Manual of Operations: Part 2, Data Definitions & Infant Data Forms, Release 18.0, Published November 2013, which is adopted and incorporated by reference.

(9) "Maternal risk factors" include: Ethnicity of Mother, Race of Mother, Prenatal Care, Antenatal Steroids, Antenatal Magnesium Sulfate, Chorioamnionitis, Maternal Hypertension, Chronic or Pregnancy-Induced, Multiple Gestation, all as defined by the Vermont Oxford Network 2014 Manual of Operations: Part 2, Data Definitions & Infant Data Forms, Release 18.0, Published November 2013.

(10) "Guidelines for Perinatal Care" means the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care (7th ed.), October 2012 (ISBN-13: 9781581107340, ISBN: 158110734X), which are adopted and incorporated by reference.

 

R433-1-3. Reporting of VLBW Maternal and Infant Data by Hospital Facilities.

Each hospital that admits a VLBW infant shall report to the Department within 40 days of discharge or death, if the infant dies in the hospital, the following:

(1) child's name;

(2) child's date of birth;

(3) mother's name;

(4) mother's date of birth;

(5) mother's zip code

(6) delivery hospital;

(7) maternal risk factors;

(8) major morbidities for the child;

(9) age of infant at admission; in hours if the infant is less than 24 hours old and in days if the child is older than 24 hours;

(10) infant's discharge status (e.g., transported to other facility, discharged to home, death)

(11) age of child at discharge; in hours if the infant is less than 24 hours old and in days if the child is older than 24 hours;

(12) if transported to another hospital, the name of the hospital.

 

R433-1-4. Reporting of Capacity to Care for VLBW Infants, as Outlined by the 7th Edition of the Guidelines for Perinatal Care, to the Department.

Each hospital with a NICU or a Nursery that admits or cares for VLBW infants shall report as requested by the Department its capability to treat VLBW infants. The hospital shall submit its report within 30 days of the Department request. The Department's request shall be in the form of a survey based on the Guidelines for Perinatal Care and may be made no more than once in a calendar year. The medical director and nursing director of the NICU or nursery shall jointly complete the survey. Medical directors and nursing directors are encouraged to report significant changes in capability more frequently.

 

R433-1-5. Record Abstraction.

A hospital or health care provider that treats an infant born VLBW shall, as provided in Utah Code, Title 26, Chapter 25, allow personnel from the Department or its agents to abstract information from the hospital's or health care provider's files on the mother and infant regarding issues related to the care and treatment of the VLBW infant.

 

R433-1-6. Confidentiality.

(1) Information that the Department holds under this rule is confidential under the provisions of Title 26, Chapter 3. Because of the public interest needs to foster health care systems improvements, the Department exercises its discretion under Section 26-3-8 and shall not release information collected under this rule to any person pursuant to the provisions of Subsections 26-3-7(1) or (8).

(2) Information produced or collected by a facility is confidential and privileged under the provisions of Title 26, Chapter 25.

 

R433-1-8. Liability.

As provided in 26-25-1, facilities that report, and those individuals submitting the report, as required by this rule, information covered by this rule may not be held liable for reporting the information to the Department.

 

R433-1-9. Penalties.

Pursuant to Section 26-23-6, a person that willfully violates any provision of this rule may be assessed an administrative civil money penalty not to exceed $10,000 per violation.

 

KEY: very low birth weight infant, very low birth weight infant reporting, very low birth weight infant treatment capability

Date of Enactment or Last Substantive Amendment: [2014]2015

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

 


Additional Information

More information about a Notice of Change in Proposed Rule is available online.

The Portable Document Format (PDF) version of the Bulletin is the official version. The PDF version of this issue is available at https://rules.utah.gov/publicat/bull-pdf/2015/b20150101.pdf. The HTML edition of the Bulletin is a convenience copy. Any discrepancy between the PDF version and HTML version is resolved in favor of the PDF version.

Text to be deleted is struck through and surrounded by brackets ([example]). Text to be added is underlined (example).  Older browsers may not depict some or any of these attributes on the screen or when the document is printed.

For questions regarding the content or application of this rule, please contact Lois Bloebaum at the above address, by phone at 801-538-6792, by FAX at , or by Internet E-mail at lbloebaum@utah.gov.  For questions about the rulemaking process, please contact the Division of Administrative Rules.