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Montana Administrative Register Notice 37-677 No. 9   05/08/2014    
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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 PUBLIC HEARING ON PROPOSED AMENDMENT

 

 

TO: All Concerned Persons

 

            1. On May 28, 2014, at 11:00 a.m., the Department of Public Health and Human Services will hold a public hearing in Room 207 of the Department of Public Health and Human Services Building, 111 North Sanders, at Helena, Montana, to consider the proposed amendment of the above-stated rules.

 

2. The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice. If you require an accommodation, contact Department of Public Health and Human Services no later than 5:00 p.m. on May 21, 2014, to advise us of the nature of the accommodation that you need. Please contact Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail dphhslegal@mt.gov.

 

3. The rules as proposed to be amended provide as follows, new matter underlined, deleted matter interlined:

 

            37.57.301 DEFINITIONS As used in this subchapter, the following definitions apply:

            (1) and (2) remain the same.

            (3) "Newborn screening tests" are laboratory screening tests, procedures, or both for the following conditions:

            (a) through (b)(i) remain the same.

            (ii) Citrullinemia type 1;

            (iii) and (iv) remain the same.

            (v) Classic Phenylketonuria; and

            (vi) through (e) remain the same.

            (f) Primary Ccongenital hypothyroidism;

            (g) Cystic fibrosis; and

            (h) through (h)(ii) remain the same.

            (iii) Hb SS disease.; and

            (i) Critical congenital heart disease, including:

            (i) hypoplastic left heart syndrome;

            (ii) pulmonary atresia;

            (iii) tetralogy of Fallot;

            (iv) total anomalous pulmonary venous return;

            (v) transposition of the great arteries;

            (vi) tricuspid atresia; and

            (vii) truncus arteriosus.

 

AUTH: 50-19-202, MCA

IMP:     50-19-203, MCA

 

            37.57.304 VERY LOW BIRTH WEIGHT (UNDER 1,500 GRAMS) NEWBORNS HOSPITALIZED FOR NEONATAL INTENSIVE CARE (1) If a newborn is of very low birth weight, i.e., under 1,500 grams hospitalized for neonatal intensive care, a specimen of its blood must be taken for testing after 24 hours of age prior to nonrespiratory treatment and no later than seven days 48 hours of age, unless medically contraindicated, in which case the specimen must be taken as soon as the infant's medical condition permits.

            (2) In the event that the initial screening blood specimen is taken at less than 24 hours of age, another screening specimen must be taken after 48 hours of age, and no later than 7 days of age.

            (2) (3)  In the event that the newborn stays in a health care facility longer than 14 7 days following birth, a repeat congenital hypothyroid an additional screening blood specimen must be made 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) Hospitals providing neonatal intensive care are responsible for developing and implementing a protocol to ensure a newborn hospitalized for neonatal intensive care receives screening for critical congenital heart disease.

 

AUTH: 50-19-202, MCA

IMP:     50-19-203, MCA

 

            37.57.305 NEWBORNS OTHER THAN THOSE WITH VERY LOW BIRTH WEIGHT HOSPITALIZED FOR NEONATAL INTENSIVE CARE (1) For newborns at birth weights of 1,500 grams or more not requiring neonatal intensive care, the required blood specimen must be taken between 24 and 72 48 hours of age.

            (2) In the event the newborn is discharged from a health care facility prior to the third day of life 24 hours of age, the blood specimen must be taken immediately before discharge and, in addition, if the newborn is discharged before it is 24 hours old:

            (a) another specimen must be taken and submitted to the department's laboratory between the fourth second and 14th seventh day of the newborn's life; and

            (b) the health care facility must:

            (i) remains the same.

            (ii) ensure that the parent or legal guardian of the newborn signs a statement assuming responsibility to cause a specimen to again be taken between the fourth second and 14th seventh day of life of the newborn and to submit it to the department for testing.

            (3) If taking a specimen on any of the dates cited in (1) and (2) is medically contraindicated, the specimen must be taken as soon as possible thereafter as the medical condition of the newborn permits.

            (3) For newborns not requiring neonatal intensive care, a pulse oximetry screening for CCHD must be completed per the department's recommended protocol prior to discharge and after 24 hours of age and screening results reported to the department as required by this subchapter.

            (4) In the event the newborn is discharged from a health care facility prior to 24 hours of age, pulse oximetry screening must be completed immediately before discharge and the health care facility must:

            (a) provide education to the newborn's family on the implications of screening prior to 24 hours of age;

            (b) provide information on the optimal timing of a repeat screening and a location where repeat screening can be done; and

            (c) document (a) and (b) in the newborn's medical record.

 

AUTH: 50-19-202, MCA

IMP:     50-19-203, MCA

 

            37.57.306 TRANSFER OF NEWBORN INFANT (1) In the event of transfer of a newborn from one health care facility to another, or from a place of birth that is not a health care facility to a health care facility, the a screening blood specimen required must be taken and submitted by the receiving health care facility unless a sample was taken and submitted by the transferring health care facility or other responsible person.

            (2) remains the same.

            (3) In the event of a transfer of a newborn from one health care facility to another, or from a place of birth that is not a health care facility to a health care facility, pulse oximetry screening for CCHD must be completed after 24 hours of age by the receiving health care facility and screening results reported to the department as required by this subchapter.

 

AUTH: 50-19-202, MCA

IMP:     50-19-203, MCA

 

            37.57.307 INFANT BORN OUTSIDE HEALTH CARE FACILITY (1) When an infant is born outside of a health care facility and is not subsequently transferred to a health care facility for initial newborn care, it is the responsibility of one of the persons designated in 50-15-221(4)(a), (b), and (c), MCA, in the order of priority indicated therein, to cause the blood specimen to be taken and submitted, and to cause pulse oximetry screening to be performed as required by this subchapter.

 

AUTH: 50-19-202, MCA

IMP:     50-19-203, MCA

 

            37.57.308 NEWBORN EYE TREATMENT (1) A physician, nurse-midwife, or any other person who assists at the birth of any newborn must, within the time limit stated in (3) below, instill or have instilled into each conjunctival sac of the newborn, one of the following:

            (a) erythromycin (0.5%) ophthalmic ointment or drops from single-use tubes or ampules;

            (b) tetracycline (1%) ophthalmic ointment or drops from single-use tubes or ampules; or

            (c) silver nitrate solution (1%) in single-dose ampules.

            (2) and (3) remain the same.

 

AUTH: 50-1-202, MCA

IMP:     50-1-202, MCA

 

            37.57.315 TRANSFUSION: WHEN BLOOD SPECIMEN TAKEN (1) If a newborn needs a transfusion, blood specimens for the tests required by this subchapter must be taken before the transfusion takes place unless medically contraindicated.

            (2) If the newborn is transfused prior to collection of the initial newborn screening specimen, a screening specimen must be taken 90 to 120 days after the last transfusion to screen for classical galactosemia and hemoglobinopathies. This specimen is in addition to those required elsewhere in this chapter.

           

AUTH: 50-19-202, MCA

IMP:     50-19-203, MCA

 

            37.57.316 ABNORMAL TEST RESULT REPORTING SCREENING RESULTS (1) If an initial test screening results on an infant's blood specimen is outside are within the expected or normal range:

            (a) the department will report that fact within 24 hours of test completion to the attending physician or midwife, or, if there is none or the physician or midwife is unknown, to the person who registered the infant's birth; the results to the submitter of the specimen and, in addition, to the infant's healthcare provider(s) upon request.

            (b) the person to whom the above report is made must ensure that within 48 hours of receiving the notification of an abnormal test result, a second blood specimen will be taken and submitted to the department for a second test.

            (2) If the second test result is outside the expected or normal range: infant's blood specimen is of unsatisfactory quality for testing,

            (a) the department will provide the test results within 24 hours of test completion to the same person to whom the initial results were reported; notify the submitter of the need for collection of an additional specimen. The submitter must ensure collection of this specimen in a timely manner within three days of notification.

            (b) that person must ensure that a serum specimen from the infant is immediately sent either to the department or to another approved laboratory qualified to perform quantitative analysis for the substance in question;

            (c) if the specimen is sent to a laboratory other than the department's, the person who submits it must send the department a copy of the analysis report for the specimen within 24 hours after receiving the report.

            (3) If screening results on an infant's blood specimen are outside the expected or normal range:

            (a) the department will report results to the submitter of the specimen and to the healthcare provider(s) for the infant. Recommendations for follow-up actions contained in the report are determined by the department;

            (b) the provider(s) will ensure that all repeat screening, confirmatory testing, or both, as recommended, is collected and submitted to the department or an approved laboratory within 48 hours or as clinically appropriate;

            (c) if a referral to a contracted specialist is made by the department, the specialist will ensure that all confirmatory testing results and final diagnosis are reported to the department within one week of the determination of the final diagnosis.

            (3) (4) An approved laboratory for confirmatory testing following out-of-range blood screening results includes any state or territorial health department laboratory and any laboratory within their jurisdictions which is approved by them, a U.S. public health service laboratory, a laboratory operated by the U.S. Armed Forces or Veteran's Administration, a Canadian provincial public health laboratory, and any laboratory licensed under the provisions of the Clinical Laboratories Improvement Act of 1967, as amended.

            (5)  Each person in charge of any health care facility and each person responsible under ARM 37.57.307 for a birth occurring outside a health care facility must report to the department regarding pulse oximetry screening per department guidelines.

 

AUTH: 50-19-202, MCA

IMP:     50-19-203, MCA

 

            37.57.320 RESPONSIBILITIES OF REGISTRAR OF BIRTH: ADMINISTRATOR OF HEALTH CARE FACILITY (1) Each person in charge of any health care facility and each person responsible under ARM 37.57.307 for a birth occurring outside a health care facility must:

            (a) remains the same.

            (b) be certain, prior to the discharge of the newborn, that the specimen to be forwarded to the laboratory is adequate for testing purposes;

            (c) within 24 hours after the taking of the specimen, cause such specimen to be forwarded to the department's laboratory by either courier or first-class mail or its equivalent; and

            (d) record on the newborn's chart or file in the newborn's medical record the date of taking of the test specimen and the results of the tests performed when reported by the department.;

            (e) ensure that pulse oximetry is performed per the department's recommended protocol for the purpose of performing newborn screening for CCHD as follows:

            (i) ensure that the screening is performed on equipment that has been approved by the FDA for use on newborns and is motion tolerant;

            (ii) ensure that screening is performed by licensed staff who have been trained on the screening procedure and protocol;

            (iii) record in the newborn's medical record the date, time, and screening results;

            (iv) ensure that the pulse oximetry screening results are reported to DPHHS as required by this subchapter;

            (v)  ensure that a policy and procedure is in place for immediate follow-up of a failed CCHD screen; and

            (f) use educational materials provided by the department and must provide education to the newborn's family on the following:

            (i) the conditions that may be detected through bloodspot screening and pulse oximetry screening;

            (ii) the importance of newborn screening tests to detect potentially life- threatening conditions;

            (iii) the process for collecting bloodspot screening and conducting pulse oximetry screening; and

            (iv) after hearing all the benefits of newborn screening and the risks involved in refusing testing, a parent/legal guardian may refuse either of the above screenings. In that case, the parent/legal guardian must sign a waiver for the newborn's medical record in which they accept responsibility for adverse consequences. A copy of this waiver must be provided to the department.

 

AUTH: 50-19-202, MCA

IMP:     50-19-203, MCA

 

            37.57.321 STATE LABORATORY: RESPONSIBILITY FOR TESTS

            (1) Only those newborn screening blood tests performed by the department laboratory or, in the case described in ARM 37.57.316, a laboratory approved by the department, meet the requirements of 50-19-201, 50-19-202, 50-19-203, and 50-19-204, MCA.

            (2) Dried blood specimens remaining after newborn screening test completion are the property of the department laboratory and will be stored for one calendar year prior to destruction. Any dried blood specimens sent to a laboratory approved by the department for testing will be destroyed after one year by the approved laboratory. An exception is made for screening specimens with results that are out of range which may be kept for quality improvement and new method development within the laboratory. These specimens may be stored by the laboratory for an indefinite period of time.

 

AUTH: 50-19-202, MCA

IMP:     50-19-203, MCA

 

            4. STATEMENT OF REASONABLE NECESSITY

 

The Department of Public Health and Human Services (the department) is proposing amendments to 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 regarding newborn screening and follow-up.

 

These changes are necessary to conform to the federal Health Resources and Services Administration's (HRSA) "Recommended Uniform Screening Panel" for all newborns, to update newborn eye prophylaxis to reflect current standards of care, and to update newborn bloodspot screening procedures and protocols to reflect current standards of care.

 

ARM 37.57.301

 

The department is proposing changes to the list of definitions for infant screening tests. The definition of "newborn screening tests" has been updated so that it is more reflective of the different types of newborn screening being performed. Changes to "Citrullinemia type I," "Classic Phenylketonuria," and "Primary Congenital hypothyroidism" have been made to reflect current medical terminology. "Critical Congenital Heart Disease" (CCHD) is a new entry. These changes are necessary to keep the list of definitions current and reflective of HRSA's Recommended Uniform Screening Panel for all newborns.

 

ARM 37.57.304

 

The department is proposing changes for the screening of newborns hospitalized for neonatal intensive care. These changes update bloodspot screening protocol to reflect current standards of care and add language requiring screening for CCHD. These changes are necessary to provide the most current and accurate information to providers and to the department.

 

ARM 37.57.305

 

The department is proposing changes for the screening of newborns who are not hospitalized for neonatal intensive care. These changes update the bloodspot screening protocol to reflect current standards of care and add language requiring CCHD screening. The protocol for CCHD screening recommended by the department is the screening protocol recommended by the American Academy of Pediatrics, the American Heart Association, the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children, and The American College of Cardiology Foundation. These changes are necessary to provide the most current and accurate information to providers and to the department.

 

ARM 37.57.306

 

The department is proposing changes for the screening of newborns who are transferred to a health care facility. These changes clarify the requirement of a receiving facility for taking a blood specimen in order to eliminate confusion. Language is also added requiring the receiving facility to perform CCHD screening per the recommended protocol and to report screening results to the department. These changes are necessary to clarify who is responsible for screening in the event of a newborn transfer.

 

ARM 37.57.307

 

The department is proposing changes for the screening of an infant born outside of a health care facility. These changes add language requiring screening for CCHD and are necessary to conform to HRSA's Recommended Uniform Screening Panel for all newborns.

 

ARM 37.57.308

 

The department is proposing changes to newborn eye treatment. Language describing medications to be used has been taken out due to these preparations no longer being available in the United States for newborn eye prophylaxis. These changes are necessary to reflect current standards of care.

 

ARM 37.57.315

 

The department is proposing changes for bloodspot screening of newborns who require a transfusion. These changes are necessary to reflect current standards of care and to provide the most current and accurate information to providers.

 

ARM 37.57.316

 

The department is proposing changes for the reporting of newborn screening results. Language is added to further clarify reporting, testing, and/or specimen submission requirements when an in-range or out-of-range screening result is obtained or when a blood specimen is of unsatisfactory quality for testing.  Additionally, language is added to require reporting of CCHD screening results to the department. This information is necessary for the department to conduct quality assurance, surveillance, and technical assistance for CCHD screening.

 

ARM 37.57.320

 

The department is proposing changes to the responsibility of the registrar of birth. Language is added to clarify how bloodspot specimens are to be forwarded to the department laboratory and how bloodspot screening is to be recorded. These changes are necessary to ensure timely collection and submission of newborn blood specimens and accurate reporting of results.

 

Language is also added to include screening for CCHD with adequate equipment by trained staff. Recording of screening results in the newborn's medical record as well as reporting results to the department are also added. These additions are necessary to conform to HRSA's Recommended Uniform Screening Panel for all newborns and to ensure that screening is conducted in a manner which will reduce the potential for screening error.

 

Language is added to clarify the newborn screening education that is to be provided to families as well as the procedure for refusal of screening. These changes are necessary to provide the most complete and accurate information to families, providers, and the department.

 

ARM 37.57.321

 

The department is proposing changes to the responsibilities of the state laboratory. The proposed changes clarify the retention, use, and destruction/disposal of blood specimens submitted to the laboratory for the purpose of newborn screening. These changes are necessary to provide accurate information to families, providers, and the department.

 

Fiscal Impact

 

The adoption of the proposed amendments to the administrative rules listed above could have a fiscal impact on the following groups in Montana: newborns and their families, birthing hospitals, birthing centers, and small businesses providing direct-entry midwifery services.

 

Impact to birthing hospitals, birthing centers, and small businesses providing direct-entry midwifery services in Montana: There are currently 28 birthing hospitals in Montana. The proposed changes to newborn eye prophylaxis and to newborn bloodspot screening are not expected to have a fiscal impact on these businesses.

Estimated costs that may be incurred to perform newborn screening for critical congenital heart disease include the following items.

 

1. The purchase of adequate screening equipment equals $500-$2,000.

 

2. The cost of screening procedure and time is estimated to be about $13.50 per newborn including staff time and the screening probe. This cost is reduced if reusable screening equipment is used. The estimated time to complete the screening is ten minutes.

 

3. The cost of education and training of staff on the screening procedure and protocol includes staff wages and time. The amount of time necessary to become proficient at screening with the protocol will vary with the individual and therefore is difficult to estimate. Many free educational resources are available online and some training may also be provided by the department.

 

Other Fiscal Considerations

 

Recording of screening results and reporting to the department recording screening results in the newborn's medical record may require additional staff time depending on the business' current recording practices. Reporting screening results to the department will be in a manner consistent with newborn hearing screening reporting to minimize the staff time required for reporting.

 

Family education materials will be provided by the department.

 

Currently there is not a billable current procedural terminology (CPT) code for critical congenital heart disease screening so the cost of screening cannot be directly reimbursed by health payors like Medicaid, insurance, etc. However, Center for Disease Control (CDC) researchers found that screening for CCHD is cost-effective because of the reduction in hospitalization costs associated with late detected CCHD and the potential reduction in deaths.

 

Number of Persons Affected

 

There are approximately 12,000 babies born in Montana every year. The proposed changes to newborn eye prophylaxis and newborn bloodspot screening are not expected to have a fiscal impact on these babies. Because there is not currently a billable CPT code for critical congenital heart disease screening that can be directly reimbursed by payors, it is possible that the hospitals and providers will bill families for costs associated with this screening.

 

            5. The department intends to adopt these rule amendments effective July 1, 2014.

 

            6. Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing. Written data, views, or arguments may also be submitted to: Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; fax (406) 444-9744; or e-mail dphhslegal@mt.gov, and must be received no later than 5:00 p.m., June 5, 2014.

 

7. The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

 

8. The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency.  Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices. Notices will be sent by e-mail unless a mailing preference is noted in the request. Such written request may be mailed or delivered to the contact person in 6 above or may be made by completing a request form at any rules hearing held by the department.

 

9. An electronic copy of this proposal notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register.  The Secretary of State strives to make the electronic copy of the notice conform to the official version of the notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the notice and the electronic version of the notice, only the official printed text will be considered.  In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

 

10. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

 

11. With regard to the requirements of 2-4-111, MCA, the department has determined that the amendment of the above-referenced rules will significantly and directly impact small businesses.

 

 

/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 April 28, 2014.

 

 

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