No. 38802 (New Rule): Rule R433-1. Very Low Birth Weight Infant Reporting

(New Rule)

DAR File No.: 38802
Filed: 08/21/2014 05:03:01 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This new rule establishes reporting requirements for certain very low birth weight (VLBW) infant morbidities and for newborn care capabilities in Utah.

Summary of the rule or change:

This rule establishes reporting and records access requirements for certain morbidities of VLBW infants and maternal risk factors of these infants' mothers, to monitor statewide trends, define the scope of the problems in Utah and provide baseline rates for improvement activities. Morbidities to be reported include Chronic Lung Disease, Late Bacterial Infection and organism, Nosocomial Infection and organism, Central Line infection and organism, Ventilator associated pneumonia and organism, 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 DuctusArteriosis (PDA), and/or PDA surgery all as defined by the Vermont Oxford Network 2014 Manual of Operations: Part 2, Data Definitions and Infant Data Forms, Release 18.0, Published November 2013. Maternal risk factors to be reported 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 and Infant Data Forms, Release 18.0, Published November 2013. These data will be submitted by any facility that admits and cares for a VLBW infant to the Utah Department of Health (UDOH) via a secure web-based reporting tool within 40 days of the infants discharge or death. This rule also establishes reporting by each hospital with a NICU or a nursery that admits or cares for newborn infants to the UDOH its capability to treat infants and their mothers. The hospital shall submit its report within 30 days of the UDOH's request. UDOH's request shall be in the form of a web-based survey created by the UDOH and based on the Guidelines for Perinatal Care published by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists Guidelines for Perinatal Care (seventh edition) 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. These data will be submitted to the UDOH via a secure web-based reporting tool.

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)

This rule or change incorporates by reference the following material:

• Adds Guidelines for Perinatal Care, published by American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, 7th edition
• Adds Vermont Oxford Network 2014 Manual of Operations: Part 2, Data Definitions and Infant Data Forms, published by Vermont Oxford Network, Release 18.0

Anticipated cost or savings to:

the state budget:

Anticipated one-time costs of $1,200 will be incurred from existing budget resources for the development of a secure web-based reporting tool. Ongoing costs for data storage are estimated to be $4,800 per year and also will be incurred from existing budget resources. The web-based tool will allow facilities to submit their reports online, to track their reports, and for UDOH staff to conduct data analysis. Analysis of the data and report out will be achieved by the Bureau of Maternal Child Health staff assigned to this program who will conduct periodic statewide analyses of infant morbidities and hospital newborn care capabilities as part of its existing duties. Efforts to improve rates of severe neonatal morbidities (once baseline has been established) and assure hospitals are self-designating LOC appropriately will in the long run benefit Utah infants and their families including Medicaid recipients and the costs associated with excess healthcare expenditures.

local governments:

If a local government owns a healthcare facility, this may have an indirect impact on the subsidy they are providing to that facility. Currently there are only six hospitals that fall in this category and they are rural. The incidence of severe infant morbidities in these smaller rural facilities tends to be low as mothers are usually transported to tertiary care centers in anticipation of such an event or infants are air transported soon after birth. In the unlikely event that they admit a VLBW infant with severe morbidities, the impact for reporting morbidities will be negligible with the web-based reporting system. The hospital LOC survey will also be web-based and is estimated to require approximately 30 to 60 minutes to complete at an average nurse's salary rate of $34 per hour and physician's salary of $100 per hour annually.

small businesses:

Two licensed hospitals in Utah, which will be required to report morbidities and newborn care capabilities have fewer than 50 employees on their payroll. Expected costs to these hospitals are anticipated to be minimal as the incidence of severe infant morbidities in these smaller rural facilities tends to be low as mothers are usually transported to tertiary care centers in anticipation of such an event or infants are air transported soon after birth. In the unlikely event that they admit an infant with severe morbidities, the impact for reporting morbidities will be negligible with the web-based reporting system. The hospital LOC survey will also be web-based and is estimated to require approximately 30 to 60 minutes to complete at an average nurse's salary rate of $34 per hour and physician's salary of $100 per hour annually.

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

Individual patients will not be directly affected by the reporting requirement, but should in the future, if statewide improvement interventions are developed and adopted, experience a drop in morbidity rates and expenses associated with severe infant morbidities.

Compliance costs for affected persons:

Actual costs will depend on the level of neonatal care the hospital provides. There were a total of 574 VLBW infants born in Utah hospitals during 2012 (see Utah Vital Statistics Birth Certificate Data, 2012). The 15 level I hospitals are expected to incur very minimal costs for reporting infant morbidities as, the number of VLBW infants born in these facilities was zero to two during 2012. The 1 Level I facilities do not have the capacity to care for VLBW infants and if at all possible mothers are transported to high level care centers in anticipation of a preterm birth or VLBW infants are air transported soon after birth and therefore not admitted. The 15 Level II hospitals expected costs may be slightly higher than Level I hospitals as zero to eight VLBW infants were born in Level II facilities during 2012. Again, Level II facilities do not have the capacity to care for VLBW infants, therefore mothers are transported to higher level care centers in anticipation of a preterm event or VLBW infants are air transported soon after birth and therefore not admitted. Rarely, a VLBW infant is born healthier than expected and admitted and cared for at a Level II facility. Estimating that the average time spent on submitting severe morbidity data on-line will be 30 to 40 minutes per infant at an average nurse's salary rate of $34 per hour, the total annual cost to Level II hospitals would range between $0 to $136. The remaining eleven Level III facilities would experience the greatest time and costs for reporting severe infant morbidities. UDOH has attempted to be sensitive to any burden placed on these facilities by requiring the minimum number of conditions to be reported. UDOH has also required that data submitted are in the same format as data that all 11 facilities currently submit to national private quality improvement systems, e.g. Vermont Oxford Network. According to Utah Vital Statistics birth certificate data the number of VLBW infants born in these facilities ranged between 15 to 145 during 2012 with only two hospitals reporting more than 100 VLBW infant births during 2012. Estimating that the average time spent on submitting severe morbidity data on-line will be 45 to 60 minutes per infant at an average nurse's salary rate of $34 per hour and that Level III facilities would care for approximately 15 to 145 VLBW infants per year, the total annual cost to Level III hospitals would range between $382.50 and $3,698. The hospital LOC survey will also be web-based and is estimated to require approximately 30 to 60 minutes to complete at an average nurse's salary rate of $34 per hour and physician's salary of $100 per hour annually.

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

The agency developed the reporting requirements in conjunction with the affected hospitals. This will have minimal effect on business due to the small number of individuals subject to this rule.

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 [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:

10/15/2014

This rule may become effective on:

10/22/2014

Authorized by:

David Patton, 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, 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), PDA surgery, 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

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

 

 

---