Administrative Rules of the State of Montana

BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

In the matter of the amendment of ARM 37.57.301, 37.57.304, 37.57.305, 37.57.306, 37.57.307, 37.57.308, 37.57.315, 37.57.316, 37.57.320, and 37.57.321 pertaining to newborn screening and follow-up of failed screenings

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NOTICE OF AMENDMENT

TO: All Concerned Persons

1. On May 8, 2014, the Department of Public Health and Human Services published MAR Notice No. 37-677 pertaining to the public hearing on the proposed amendment of the above-stated rules at page 939 of the 2014 Montana Administrative Register, Issue Number 9.

2. The department has amended ARM 37.57.301, 37.57.305, 37.57.306, 37.57.307, 37.57.308, 37.57.315, 37.57.316, 37.57.320, and 37.57.321 as proposed.

3. The department has amended the following rule as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:

37.57.304 NEWBORNS HOSPITALIZED FOR NEONATAL INTENSIVE CARE (1) and (2) remain as proposed.

(3) In the event that the newborn stays in a health care facility ~~longer than~~ past 7 days ~~following birth~~ of age, an additional screening blood specimen must be taken either at the time of discharge if the stay is less than one month, or at one month of age if the stay is one month or longer.

(4) remains as proposed.

AUTH: 50-19-202, MCA

IMP: 50-19-203, MCA

4. The department has thoroughly considered the comments and testimony received. A summary of the comments received and the department's responses are as follows:

COMMENT #1: The department received multiple comments that express support for newborn pulse oximetry screening for critical congenital heart disease (CCHD) including:

1 in 100 babies are born with some form of a congenital heart defect and pulse oximetry is a low-cost, non-invasive test that can be effective at detecting some of the most critical heart defects.

The pulse oximetry test is accurate at detecting hypoxemia which can be a sign of CCHD or of another problem that requires immediate intervention and may not be apparent on physical exam.

Infants with CCHD that are not detected early have higher rates of morbidity and mortality.

Personal accounts of babies with CCHD, not tested or identified at birth, and their prolonged hospital course and even death were given.

Reporting of screening results to the department is necessary to maintain and improve a quality testing and follow-up program.

RESPONSE #1: The department agrees with these comments.

COMMENT #2: The department received four comments requesting that Severe Combined Immunodeficiency (SCID) be added to newborn screening in Montana, including the following:

SCID is an immunodeficiency disease that is a pediatric emergency. Infants with this condition lack the white blood cells that are necessary to fight off bacteria and viruses resulting in serious, life-threatening infections.

Screening for SCID through newborn bloodspots is now available and may also identify other, less severe immunodeficiencies.

When this condition is identified early, treatment with a bone marrow transplant is highly effective and morbidity and mortality are greatly reduced.

RESPONSE #2: The department is currently evaluating the program requirements for inclusion of SCIDs in the newborn screening panel. Similar to the addition of any newborn screening test, one must consider a number of resource requirements which include availability of testing/technology for both primary and confirmatory screening, the capability to provide resources for short and long-term follow-up for SCIDs newborns and those additional babies with a variety of conditions that will require follow-up after primary screening, and ultimately the resources to provide bone marrow transplantation and ongoing clinical care to those children afflicted with this inherited disorder. Financial support to develop and maintain this program capability is both practical and necessary. Currently, most of these resources are not in place or do not exist within the Montana.

COMMENT #3: This comment suggested adding wording to ARM 37.57.304(4) to include all levels of nursery care, not just neonatal intensive care, indicating that additional wording would ensure that infants in a "special care" nursery should also be screened for CCHD.

RESPONSE #3: The department agrees that infants in all levels of nursery care should be screened for CCHD; however, these infants would fall under ARM 37.57.305. Reminding providers that this includes all levels of infant nurseries will be an important part of provider education.

COMMENT #4: Two comments suggested revising the time frame in ARM 37.57.305(3) to show that CCHD screening should be completed after 24 hours of age and before 48 hours of age. 24-48 hours of age is the optimal timing for this screening to be completed so that infants with CCHD can be identified prior to becoming symptomatic.

RESPONSE #4: The department agrees that research demonstrates 24-48 hours of age is the optimal time to conduct screening. However, because there is a possibility that an infant older than 48 hours of age could have CCHD and not be symptomatic, the department does not want to limit screening only to those infants within the 24-48 hour age range. Informing providers of the optimal time frame to conduct screening and stressing the importance of early identification of CCHD will be a key part of provider education.

COMMENT #5: This comment pointed out discrepancies in language used between sections ARM 37.57.304(3) "7 days following birth" and ARM 37.57.305(2)(a) "7th day of life" indicating that they are two different time frames. This comment suggested revising the language to be consistent throughout the rules.

RESPONSE #5: The department agrees with this comment and has revised the proposed amendments to reflect consistent language.

COMMENT #6: This comment noted that the current amendments include time frames for bloodspot specimen collection and for when the specimen must be forwarded to the laboratory. However, these amendments do not address a time frame for when the specimen must arrive at the lab and when the results must be reported to the provider. If specimens do not arrive at the lab in a timely manner or if they are not reported to providers in a timely manner, treatment of the condition could be delayed, potentially leading to complications for the infant. This commenter suggested including time frames in the rules for when the specimen must arrive at the lab and when lab results must be reported to providers based on national recommendations.

RESPONSE #6: The newborn screening program is aware of the latest recommendations by the Secretary's Discretionary Advisory Committee on Heritable Disorders in Newborns and Children regarding the timeliness of newborn screening and welcomes this input from concerned citizens and groups. We are actively working with internal and external stakeholders to set and achieve similar performance standards for newborn screening in the state of Montana. Achieving these performance standards may be addressed by administrative rule change, as in the suggested modifications to the current rule, as well as by programmatic quality improvement measures.

COMMENT#7: This comment noted that the amendments proposed in this rule are likely to have a significant impact on midwives in Montana. Not all midwives currently have pulse oximeters that can be used for CCHD screening and the equipment can be expensive. This comment requested support from the department to provide midwives with the education and resources necessary to complete newborn screening.

RESPONSE #7: The department agrees with this comment and will work with midwives to implement the rules.

5. These rule amendments are effective July 1, 2014.

/s/ Shannon L. McDonald /s/ Richard H. Opper

Shannon L. McDonald Richard H. Opper, Director

Rule Reviewer Public Health and Human Services

Certified to the Secretary of State June 16, 2014