REVISED PROPOSED REGULATION OF THE STATE BOARD OF HEALTH

LCB File No. R088-20

July 13, 2021

EXPLANATION – Matter in italics is new; matter in brackets [omitted material] is material to be omitted.

AUTHORITY: §§ 1-8, NRS 439.200 and 442.008.

A REGULATION relating to health care; revising requirements concerning the screening of infants for preventable and inheritable disorders and the management of such disorders; and providing other matters properly relating thereto.

Legislative Counsel’s Digest:

Existing law requires the State Board of Health to adopt regulations governing examinations and tests required for the discovery of preventable or inheritable disorders in infants. Existing law requires those examinations and tests to include tests and examinations for each disorder for which screening is recommended by the Health Resources and Services Administration of the United States Department of Health and Human Services by not later than 4 years after the recommendation is published. To accomplish this testing, existing law requires any physician, midwife, nurse, obstetric center or hospital of any nature attending or assisting in any way any infant, or the mother of any infant, at childbirth to: (1) examine the infant to the extent required by regulations of the State Board of Health; and (2) collect and send to the State Public Health Laboratory any specimens needed for the examinations and tests that must be performed by a laboratory. (NRS 442.008) Section 2 of this regulation adopts by reference the Recommended Uniform Screening Panel published by the Health Resources and Services Administration and a publication of the Clinical and Laboratory Standards Institute concerning the collection of blood samples from infants. Section 3 of this regulation: (1) requires all blood samples taken from infants to be taken in accordance with that publication and sent to the State Public Health Laboratory; and (2) prescribes the information that must be provided to the State Public Health Laboratory with each blood sample. Section 4 of this regulation makes a conforming change to indicate the placement of sections 2 and 3 in the Nevada Administrative Code.

Existing regulations require a hospital or obstetric center at which an infant is born to take a blood sample from the infant at certain times and at certain stages of the infant’s life. (NAC 442.030, 442.040, 442.044) Existing regulations require that a blood sample be taken from an infant not later than the seventh day of the infant’s life and sent to the State Public Health Laboratory for screening. (NAC 442.030) Section 5 of this regulation expands the requirement that an obstetric center or hospital take a blood sample from an infant not later than the seventh day of an infant’s life to also apply to any physician, midwife or nurse attending an infant orthe

mother of an infant at childbirth. Section 5 also requires such a physician, midwife, nurse, obstetric center or hospital to ensure the performance of testing, other than testing that must be performed in a laboratory, for each disorder for which screening is recommended by the Health Resources and Services Administration. If the testing reveals the existence of such a disorder, section 5 requires the physician, midwife, nurse, obstetric center or hospital to ensure that the disorder is: (1) reported to the appropriate public health authorities; and (2) discussed with the parent or guardian of the infant. Section 6 of this regulation revises the requirement in existing regulations that one blood sample be taken from an infant who receives care in a hospital for more than 15 consecutive days to instead require three blood samples to be taken from an infant who receives extended care in a hospital. If the infant requires a blood transfusion and the transfusion must be done before the first blood sample is taken, section 6 requires a fourth sample to be taken 120 days after the transfusion instead of between the third and seventh day after the transfusion, as required under existing regulations. (NAC 442.044)

Section 7 of this regulation requires the State Public Health Laboratory, upon receiving the blood sample of an infant, to perform the laboratory tests necessary to detect each disorder for which screening is recommended by the Health Resources and Services Administration. If the testing reveals the existence of such a disorder, section 7 requires: (1) the State Public Health Laboratory to report the result to the Nevada Newborn Screening Program at the University of Nevada, Reno, and the primary provider of health care for the infant; and (2) the Program, the provider of health care and the parent or guardian of the infant to take certain actions to manage the disorder.

Existing regulations impose certain requirements related to the taking of a blood sample from an infant born in a hospital. (NAC 442.050) Section 8 of this regulation extends these requirements with respect to an infant born in an obstetric center.

Section1.    Chapter 442 of NAC is hereby amended by adding thereto the provisions set forth as sections 2 and 3 of thisregulation.

Sec.2.    1.    The Recommended Uniform Screening Panel published by theHealth

Resources and Services Administration of the United States Department of Health and Human Services is hereby adopted by reference. The publication is available, free of charge, at the Internet address https://www.hrsa.gov/advisory-committees/heritable-disorders/rusp/,or,

if that Internet website ceases to exist, from the Division.

Dried Blood Spot Specimen Collection for Newborn Screening, 7th Edition,published

by the Clinical and Laboratory Standards Institute, is hereby adopted by reference. The publication is available for $180 from the Clinical Laboratory Standards Institute at the Internet address https://clsi.org/standards/products/newborn-screening/documents/nbs01.

If the publication adopted by reference in subsection 1 or 2 is revised, the Division will review the revision to determine its suitability for this State. If the Division determines that the revision is not suitable for this State, the Division will hold a public hearing to review its determination and give notice of that hearing within 90 days after the date of the publication of the revision. If, after the hearing, the Division does not revise its determination, the Division will give notice that the revision is not suitable for this State within 90 days after the hearing. If the Division does not give such notice, the revision becomes part of the publication adopted by reference in subsection 1 or 2, asapplicable.

Sec.3.    1.    Any blood sample taken pursuant to NAC 442.030 to 442.044, inclusive, must be taken in the manner prescribed by the publication adopted by reference in subsection 2 of section 2 of thisregulation.

2.    A physician, midwife, nurse, obstetric center or hospital that takes a blood samplefrom an infant pursuant to NAC 442.030 to 442.044, inclusive, shall ensurethat:

The blood sample is placed in a newborn screening test kit obtained from the State Public Health Laboratory and provided to the State Public Health Laboratory along with at least the following information concerning thechildbirth:

The name and gender of theinfant;

The name, address and phone number of themother;

The gestational age of the infant atbirth;

The age of the infant at the time the sample wastaken;

The feeding history of theinfant;

A description of any antibiotics or hyperalimentation administered to the infant;and

Any other information requested by the State Public HealthLaboratory.

Payment for the laboratory testing required by subsection 1 of NAC 442.046 is submitted directly to the State Public Health Laboratory at the time of the testing or whenthe newborn screening test kit is obtained from the State Public HealthLaboratory.

Sec.4.    NAC 442.020 is hereby amended to read asfollows:

442.020    As used in NAC 442.020 to 442.050, inclusive[:], and sections 2 and 3 ofthis

regulation:

“Hospital” means a medical facility as defined in NRS449.0151.

“Obstetric center” has the meaning ascribed to it in NRS449.0155.

“State Public Health Laboratory” means the State Public Health Laboratory maintained by the University of Nevada School of Medicine pursuant to NRS439.240.

Sec.5.    NAC 442.030 is hereby amended to read asfollows:

442.030    1.    Except as otherwise provided in NAC 442.035,[every hospital orobstetric

center in which an infant is born must take a heel stick]any physician, midwife, nurse, obstetric

center or hospital of any nature attending or assisting in any way any infant, or the mother of any infant, at childbirth shall ensure:

That a blood sample is taken from the infant[before he or she is discharged fromthe

hospital or obstetric center. The sample must be taken]not later than the seventh day of the

infant’s life regardless of the feeding status of the infant. If an infant is discharged from a hospital or obstetric center before he or she is 48 hours of age, the hospital or obstetric center must take a [heel stick]blood sample as close as possible to the time of the infant’s discharge

from the hospital or obstetric center.

[2.    The sample must be placed in a newborn screening test kit obtained from theState

Public Health Laboratory and must be mailed to the address indicated on the kit within 24 hours

after the sample is taken.

     3.    If an infant is not born in a hospital or obstetric center, the person who islegally

responsible for registering the birth of the child must have a physician, hospital, public health

nurse or the State Public Health Laboratory take the first blood sample between the 3rd and 7th

day and the second blood sample between the 15th and 56th day of the infant’s life.

     4.    As used in this section, “heel stick blood sample” means a small amount ofblood

obtained by means of a small puncture made to the heel of an infant.]

The performance of any examinations and tests, other than tests that must be performed in a laboratory, necessary to detect the disorders described in the publication adopted by reference in subsection 1 of section 2 of thisregulation.

2.    If the examination and testing performed pursuant to paragraph (b) of subsection 1 reveals the existence of a disorder described in the publication adopted by reference in subsection 1 of section 2 of this regulation, the physician, midwife, nurse, obstetric center or hospital, as applicable, shall ensurethat:

The disorder is reported to the Chief Medical Officer or his or her designee, the local health officer of the jurisdiction in which the infant resides and the local health officer of the jurisdiction in which the infant was born;and

The disorder and options for treatment of the disorder are discussed with the parent or guardian of theinfant.

Sec.6.    NAC 442.044 is hereby amended to read asfollows:

442.044    1.    Each hospital in which an infant receives extended care[for more than15

consecutive days]shall take [a second]:

A first blood sample from the infant upon admission to that hospital and before any blood products are administered to theinfant;

A second blood sample not earlier than 48 hours but not later than 72 hours after the infant is admitted to that hospital;and

A third blood sample 28 days after the infant is admitted to that hospital or, if theinfant is discharged less than 28 days after the infant is admitted to that hospital, before the infant is discharged from thathospital.

2.    [A blood sample must be taken from any infant, regardless of age,who

requires]If an additive blood transfusion or a partial or complete exchange blood transfusion

[before the transfusion is begun. A second]is performed before a blood sample is drawn

pursuant to paragraph (a) of subsection 1, a fourth blood sample must be taken from the infant

[between the 3rd and 7th day,]120 days after the transfusion is completed.

Sec.7.    NAC 442.046 is hereby amended to read asfollows:

442.046    1.    Upon[notification by]receiving a blood sample pursuant to section 3 ofthis

regulation, the State Public Health Laboratory [that a test is abnormal or questionable, the

child’s physician or the person who is legally responsible for registering the birth of the child]

shall [cause to have taken an additional blood sample and any additional tests which are required

to evaluate the possible abnormality and shall report that action to the State Public Health

Laboratory.]perform the laboratory testing necessary to detect the disorders described in the

publication adopted by reference in subsection 1 of section 2 of this regulation.

If the testing performed pursuant to subsection 1 reveals the existence of adisorder described in the publication adopted by reference in subsection 1 of section 2 of this regulation, the State Public Health Laboratoryshall:

Report the positive test to the primary provider of health care for the infant, if any, and to the Nevada Newborn Screening Program at the University of Nevada, Reno, or its successor program. The employee of the Program who receives the reportshall:

Recommend any additional confirmatory or diagnostic testing determined by the employee to be necessary;and

Collaborate with the primary provider of health care for the infant, if any, to manage the infant until the positive test isconfirmed.

Coordinate with the Nevada Newborn Screening Program at the University ofNevada, Reno, or its successor program, to ensure the performance of the testing recommended pursuant to subparagraph (1) of paragraph (a) and the timely management of theinfant.

If the infant has a primary provider of health care, recommend that theprimary provider of health care for theinfant:

Notify the parent or guardian of the infant of the requirements of subsection 4and any follow-up testing or other actions required to confirm the presumptive diagnosis and provide any necessary referrals, including, without limitation, referrals for genetic testing or genetic counseling when necessary;and

Discuss the disorder and options for the treatment of the disorder with the parent or guardian of theinfant.

If the testing performed pursuant to subsection 1 reveals the existence of a disorder describedinthepublicationadoptedbyreferenceinsubsection1of section2ofthisregulation

and the infant does not have a primary provider of health care, the Nevada Newborn Screening Program at the University of Nevada, Reno, or its successor program, shall perform the duties described in subparagraphs (1) and (2) of paragraph (c) of subsection 2.

The parent or guardian of an infant with[an abnormal or questionable]a positivetest

result for a disorder described in the publication adopted by reference in subsection 1 of section 2 of this regulation shall , upon notification of the positive test result, promptly take the child to a [physician]provider of health care who shall ensure that a quantitative evaluation of

the problem indicated by the test result is performed.

[3.    The person taking the blood sampleshall:

     (a) Provide all available informationincluding:

          (1) The name and gender of the infant and the name and address of themother;

          (2) The feeding history of theinfant;

          (3) The gestational age of the infant atbirth;

          (4) The age of the infant at the time oftesting;

          (5) The use of antibiotics or hyperalimentation;and

          (6) Any additional information the State Public Health Laboratory mayrequire.

     (b)  Obtain a sufficient blood sample to ensure adequate diagnostic testing on theinfant.]

As used in this section, “provider of health care” means a physician or physician assistant licensed pursuant to chapter 630 or 633 of NRS or an advanced practiceregistered nurse.

Sec.8.    NAC 442.050 is hereby amended to read asfollows:

442.050    1.    [The]If an infant is born in a hospital or obstetric center, the nurse incharge

or the person legally responsible for registering the birth of the child shall:

PROPOSED REGULATION OF THE STATE BOARD OF HEALTH

LCB File No. R086-20

May 13, 2021

EXPLANATION – Matter in italics is new; matter in brackets [omitted material] is material to be omitted.

AUTHORITY: §§1-9, NRS 422A.675 and 439.200.

A REGULATION relating to child care; prescribing the procedure to apply for a grant of money from the Diapering Resources Account; requiring a grantee to enter into an operating agreement with the Division of Public and Behavioral Health of the Department of Health and Human Services and to submit certain reports; prescribing the procedure for a grantee to draw money from a grant; authorizing the Administrator of the Division to take certain actions upon a determination that a grantee no longer needs a grant or a portion thereof or is using grant money for an unauthorized purpose; and providing other matters properly relating thereto.

Legislative Counsel’s Digest:

Existing law: (1) establishes the Diapering Resources Account in the State General Fund;

requires the Administrator of the Division of Public and Behavioral Health of theDepartment of Health and Human Services to administer the Account; and (3) requires the money used in the Account to be expended to provide diapers and diapering supplies to recipients of public assistance and other low-income families in this State. Existing law requires the State Board of Health to adopt regulations prescribing the criteria for determining whether a person qualifies for assistance from the Account and the procedure for distributing money from the Account. (NRS 422A.675) Section 5 of this regulation prescribes the manner in which to apply for a grant of money from the Account and the procedure for the Division to approve or deny such applications. Section 5 also prohibits a grantee from using a grant for a purpose not authorized by law. If an application is approved, section 6 of this regulation requires the grantee to enter into an operating agreement with the Division. Section 7 of this regulation requires a grantee to submit a quarterly report to the Division concerning the success of the project funded by the grant and expected future expenditures of grant money. Section 8 of this regulation prescribes the procedure for a grantee to draw money from a grant. Section 9 of this regulation authorizes the Administrator to take certain action if the Division determines that a grantee: (1) no longer needs a grant or any portion thereof; or (2) is using a grant for an unauthorizedpurpose.

Section1.    Chapter 422A of NAC is hereby amended by adding thereto the provisions set forth as sections 2 to 9, inclusive, of thisregulation.

Sec.2.    As used in sections 2 to 9, inclusive, of this regulation, unless the context otherwise requires, the words and terms defined in sections 3 and 4 of this regulation have the meanings ascribed to them in thosesections.

Sec.3.    “Account” means the Diapering Resources Account created by NRS422A.675.

Sec.4.    “Operating agreement” means an agreement entered into pursuant to section 6 of this regulation between the Division of Public and Behavioral Health and a person or entity approved by the Division of Public and Behavioral Health to receive a grant from theAccount.

Sec.5.    1.    To receive a grant of money from the Account, a person or entity must apply to the Division of Public and Behavioral Health in the form prescribed by the Division of Public and Behavioral Health. The application must include, withoutlimitation:

The manner in which the person or entity proposes to use the grant, including,without limitation, itemized estimates of the costs of the goods and services for which the person or entity proposes to use thegrant;

A commitment to enter into an operating agreement if the application is approvedand proposed terms for the operating agreement;and

The amount of the grant for which the applicant isapplying.

The Division of Public and Behavioral Health shall determine in a public meeting whether to approve or deny an application based on the ability of the applicant to provide diapers and diapering resources to recipients of public assistance and other low-income families in thisState.

A grant of money from the Account must be used for a purpose authorized byNRS 422A.675. A grantee shall not use the grant for any otherpurpose.

Sec.6.    1.    If the Division of Public and Behavioral Health approves an application for a grant of money from the Account pursuant to section 5 of this regulation, the grantee must enter into an operating agreement with the Division of Public and Behavioral Health that specifies:

The amount of thegrant;

The manner in which the money must beused;

The date on which the application wasapproved;

The indicators of performance that the Division of Public and Behavioral Healthand the grantee will use to measure the success of the program funded by thegrant;

That the grantee must submit the report described in section 7 of thisregulation;

That the Division of Public and Behavioral Health or a designee thereof may review any document under the control of the grantee if the Division of Public and Behavioral Health or the designee determines the review to be necessary to provide financial oversight of the project;and

The date on which the grantexpires.

2.    The Administrator of the Division of Public and Behavioral Health must reviewand approve an operating agreement before the Division of Public and Behavioral Health may enter into the operatingagreement.

Sec.7.    The recipient of a grant of money from the Account shall submit to the Division of Public and Behavioral Health a quarterly report which includes, withoutlimitation:

An evaluation of the success of the project funded by the grant using each indicator of performance specified in the operatingagreement;

Projected estimates of the costs involved in the project funded by the grant for the immediately following quarter and the duration of the grant;and

The dates on which the grantee expects to draw money from the grant for theduration of the grant and the amount of money that the grantee expects to draw on eachdate.

Sec.8.    1.    To draw money from a grant from the Account, a grantee must submit a request to the Administrator of the Division of Public and Behavioral Health in the form prescribed by the Administrator of the Division of Public and Behavioral Health. Therequest must include, withoutlimitation:

The amount of money that the grantee is requesting to withdraw;and

Evidence that the grantee is meeting the indicators of performance prescribed in the operating agreement.

After receiving a request pursuant to subsection 1, the Administrator of the Division of Public and Behavioral Health shall approve or deny the request. The Administrator of the Division of Public and Behavioral Health must approve a request if the Administrator of the Division of Public and Behavioral Health determines that the grantee is in compliance with the operatingagreement.

If the Administrator of the Division of Public and Behavioral Health approves a request, the Administrator of the Division of Public and Behavioral Health must causea check to be issued to the grantee in the amount requested by thegrantee.

If the Administrator of the Division of Public and Behavioral Health denies a request, the Administrator of the Division of Public and Behavioral Health must provide to thegrantee