Proposed Text
The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:
"Abnormal screening results" means, in 12VAC5-71-210 through 12VAC5-71-250 only, all results that indicate the newborn has not passed the CCHD screening.
"Attending physician" means the physician in charge of the infant's care.
"Board" means the State Board of Health.
"Business days" means Monday through Friday from 9 a.m. to 5 p.m., excluding federal and state holidays.
"Care Connection for Children" means a statewide network of centers of excellence for children with special health care needs (CSHCN) that provides leadership in the enhancement of specialty medical services, care coordination, medical insurance benefits evaluation and coordination, management of the CSHCN pool of funds, information and referral to CSHCN resources, family-to-family support, and training and consultation with community providers on CSHCN issues.
"Care coordination" means a process that links individuals and their families to services and resources in a coordinated effort to maximize their potential and provide them with optimal health care.
"Certified nurse midwife" means a person licensed to practice as a nurse practitioner in the Commonwealth pursuant to § 54.1-2957 of the Code of Virginia and in accordance with Part II (18VAC90-30-60 et seq.) of 18VAC90-30 and 18VAC90-30-121, subject to 18VAC90-30-160.
"Chief executive officer" means a job descriptive term used to identify the individual appointed by the governing body to act in its behalf in the overall management of the hospital. Job titles may include administrator, superintendent, director, executive director, president, vice-president, and executive vice-president.
"Child" means a person less than 18 years of age and includes a biological or an adopted child, as well as a child placed for adoption or foster care unless otherwise treated as a separate unit for the purposes of determining eligibility and charges under these regulations.
"Commissioner" means the State Health Commissioner, his duly designated officer, or agent.
"Confirmatory testing" means a test or a panel of tests performed following a screened-abnormal result to verify a diagnosis.
"Core panel conditions" means those heritable disorders and genetic diseases considered appropriate for newborn screening. The conditions in the core panel are similar in that they have (i) specific and sensitive screening tests, (iii) a sufficiently well understood natural history, and (iii) available and efficacious treatments.
"Critical congenital heart disease" or "CCHD" means a congenital heart disease that places a newborn at significant risk of disability or death if not diagnosed and treated soon after birth. The disease may include, but is not limited to, hypoplastic left heart syndrome, pulmonary atresia (with intact septum), tetralogy of fallot, total anomalous pulmonary venous return, transposition of the great arteries, tricuspid atresia, and truncus arteriosus.
"CCHD screening" means the application of screening technology to detect CCHD.
"Department" means the state Department of Health.
"Dried-blood-spot specimen" means a clinical blood sample collected from an infant by heel stick method and placed directly onto specially manufactured absorbent specimen collection (filter) paper.
"Echocardiogram" means a test that uses an ultrasound to provide an image of the heart.
"Guardian" means a parent-appointed, court-appointed, or clerk-appointed guardian of the person.
"Healthcare provider" means a person who is licensed to provide health care as part of his job responsibilities and who has the authority to order newborn dried-blood-spot screening tests.
"Heritable disorders and genetic diseases" means pathological conditions (i.e., interruption, cessation or disorder of body functions, systems, or organs) that are caused by an absent or defective gene or gene product, or by a chromosomal aberration.
"Hospital" means any facility as defined in § 32.1-123 of the Code of Virginia.
"Infant" means a child less than 12 months of age.
"Licensed practitioner" means a licensed health care provider who is permitted, within the scope of his practice pursuant to Chapter 29 (§ 54.1-2900 et seq.) or Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia, to provide care to a newborn.
"Low protein modified foods" means foods that are (i) specially formulated to have less than one gram of protein per serving, (ii) intended to be used under the direction of a physician for the dietary treatment of an inherited metabolic disease, (iii) not natural foods that are naturally low in protein, and (iv) prescribed as medically necessary for the therapeutic treatment of inherited metabolic diseases.
"Metabolic formula" means nutritional substances that are (i) prescribed by a health professional with appropriate prescriptive authority; (ii) specifically designed and formulated to be consumed or administered internally under the supervision of such health professional; (iii) specifically designed, processed, or formulated to be distinct in one or more nutrients that are present in natural food; and (iv) intended for the medical and nutritional management of patients with limited capacity to metabolize ordinary foodstuffs or limited capacity to metabolize certain nutrients contained in ordinary foodstuffs.
"Metabolic supplements" means certain dietary or nutritional substances intended to be used under the direction of a physician for the nutritional management of inherited metabolic diseases.
"Midwife" means a person licensed as a nurse practitioner in the category of certified nurse midwife by the Boards of Nursing and Medicine or licensed as a midwife by the Board of Medicine.
"Newborn" means an infant who is 28 days old or less who was born in Virginia.
"Newborn nursery" means a general level, intermediate level, or specialty level newborn service as defined in 12VAC5-410-443 B 1, B 2, and B 3.
"Nurse" means a person holding a current license as a registered nurse or licensed practical nurse by the Virginia Board of Nursing or a current multistate licensure privilege to practice in Virginia as a registered nurse or licensed practical nurse.
"Parent" means a biological parent, adoptive parent, or stepparent.
"Pediatric Comprehensive Sickle Cell Clinic Network" means a statewide network of clinics that are located in major medical centers and provide comprehensive medical and support services for newborns and children living with sickle cell disease and other genetically related hemoglobinopathies.
"Physician" means a person licensed to practice medicine or osteopathic medicine in the Commonwealth pursuant to Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia and in accordance with applicable regulations.
"Pool of funds" means funds designated for payment of direct health care services. Access to the pool is not an entitlement and is subject to availability of funds and guidelines that govern its eligibility and coverage of services. Pool of funds is a mix of federal Title V funds and state matching funds.
"Population-based" means preventive interventions and personal health services developed and available for the entire infant and child health population of the Commonwealth rather than for individuals in a one-on-one situation.
"Preterm infant" means an infant whose birth occurs by the end of the last day of the 36th week following the onset of the last menstrual period.
"Repeat specimen" means an additional newborn dried-blood-spot screening specimen submitted to the testing laboratory voluntarily or by request.
"Resident" means an individual who resides within the geographical boundaries of the Commonwealth.
"Satisfactory specimen" means a newborn dried-blood-spot screening specimen that has been determined to be acceptable for laboratory analyses by the testing laboratory.
"Screened-abnormal" means a newborn dried-blood-spot screening test result that is outside the established normal range or normal value for that test method.
"Screening technology" means pulse oximetry testing in the right hand and either foot. Screening technology shall also include alternate medically accepted tests that measure the percentage of blood oxygen saturation, follow medical guideline consensus and recommendations issued by the American Academy of Pediatrics, and are approved by the State Board of Health.
"Specialty level nursery" means the same as defined in 12VAC5-410-443 B 3 and as further defined as Level III by the Levels of Neonatal Care, written by the American Academy of Pediatrics Committee on Fetus and Newborn.
"Subspecialty level nursery" means the same as defined in 12VAC5-410-443 B 4.
"Testing laboratory" means the laboratory that has been selected by the department to perform newborn dried-blood-spot screening tests services.
"Total parenteral nutrition" or "TPN" means giving nutrients through a vein for babies who cannot be fed by mouth.
"Treatment" means appropriate management including genetic counseling, medical consultation, and pharmacological and dietary management for infants diagnosed with a disease listed in 12VAC5-71-30 D.
"Unsatisfactory specimen" means a newborn dried-blood-spot screening specimen that is inadequate for performing an accurate analysis.
"Virginia Genetics Advisory Committee" means a formal group that advises the department on issues pertaining to access to clinical genetics services across the Commonwealth and the provision of genetic awareness, quality services, and education for consumers and providers.
"Virginia Newborn Screening System" means a coordinated and comprehensive group of services, including education, screening, follow up, diagnosis, treatment and management, and program evaluation, managed by the department's Virginia Newborn Screening Program and Virginia Early Hearing Detection and Intervention Program for safeguarding the health of children born in Virginia.
"Virginia Sickle Cell Awareness Program" means a statewide program for the education and screening of individuals for the disease of sickle cell anemia or the sickle cell trait and for such other genetically related hemoglobinopathies.
A. The Care Connection for Children network shall provide the following services:
1. Care coordination services for residents of the Commonwealth who are diagnosed with selected heritable disorders , or genetic diseases , or critical congenital heart disease and are referred to the network by the Virginia Newborn Screening Program.
2. Other network services for eligible individuals in accordance with § 32.1-77 of the Code of Virginia and applicable regulations.
B. The Care Connection for Children network shall provide data as needed by the department's newborn screening program.
A. Hospitals shall develop protocols for critical congenital heart disease screening (i) in accordance with 12VAC5-71-220 through 12VAC5-71-260 and (ii) modeled after national recommendations from the American Academy of Pediatrics regarding CCHD, such as those specified in Strategies for Implementing Screening for Critical Congenital Heart Disease (Kemper et al., Pediatrics, November 2011, Volume 128, Issue 5 (2011 Nov;128(5):e1259-67) and Implementing Recommended Screening for Critical Congenital Heart Disease (Martin et al., Pediatrics, 2013, Volume 132, Issue 1 (2013 Jul;132(1):e185-92) and subsequent revisions and editions.
B. Hospitals shall develop protocols for the physical evaluation by licensed practitioners of newborns with abnormal screening results.
C. Hospitals shall develop protocols for the referral of newborns with abnormal screening results, if needed, after evaluation.
A. A licensed practitioner shall perform the CCHD screening.
B. Except as specified in subsection C of this section and 12VAC5-71-260, CCHD screening using pulse oximetry shall be performed on every newborn in the birth hospital between 24 and 48 hours of life, or if the newborn is discharged from the hospital before reaching 24 hours of life, the CCHD screening shall be performed as late as practical before discharge.
C. If CCHD screening using pulse oximetry is not performed, the reason shall be documented in the newborn's medical record. The reasons include but are not limited to:
1. The newborn's current clinical evaluation has included an echocardiogram that ruled out CCHD;
2. The newborn has confirmed CCHD;
3. The newborn is under the care of a specialty level or subspecialty level nursery, in which case the screening shall be performed in accordance with the protocols developed in subsection D of this section; or
4. The parent or guardian refuses CCHD screening on the basis of religious practices or tenets pursuant to 12VAC5-71-260.
D. Hospitals shall develop protocols for screening newborns in specialty level nurseries and subspecialty level nurseries.
A. Recording results.
1. All CCHD screening results shall be recorded in the newborn's medical record.
2. All CCHD screening results shall be entered into the electronic birth certificate system with the following information:
a. CCHD screening completed, CCHD pass or fail, and pulse oximetry values, if applicable; or
b. Not screened pursuant to 12VAC5-71-220 C 4.
B. Abnormal screening results.
1. Abnormal screening results shall be reported by the authorized health care provider who conducted the screening to the attending physician or his designee immediately.
2. A newborn shall be evaluated by an attending physician or his designee according to the timeframes within the hospital protocol developed in accordance with 12VAC5-71-210.
3. A newborn shall not be discharged from care until:
a. A cause for the abnormal screening result has been determined and a plan is in place for immediate evaluation at another medical facility; or
b. An echocardiogram has been performed and read, and an appropriate clinical plan has been developed.
4. Any diagnosis arising from abnormal screening results shall be entered into the electronic birth certificate system.
5. The attending physician or his designee shall provide notification of abnormal screening results and any diagnoses to the newborn's parent or guardian and to the primary care provider in charge of the newborn's care after the newborn leaves the hospital.
A. For any person diagnosed under 12VAC5-71-210 through 12VAC5-71-250, the chief administrative officer of every hospital, as defined in § 32.1-123 of the Code of Virginia, shall make or cause to be made a report to the commissioner in accordance with § 32.1-69.1 of the Code of Virginia.
B. Upon receiving the notification described in subsection A of this section, the Newborn Screening Program at the Virginia Department of Health shall refer the newborn's parent or guardian to the Care Connection for Children network for care coordination services.
A. The screening of newborns pursuant to this chapter is a population-based public health surveillance program as defined by the Health Insurance Portability and Accountability Act of 1996 (Public Law 104‑191; 110 Stat. 2033).
B. Upon request, a hospital shall make available to the Virginia Congenital Anomalies Reporting and Education System (VaCARES):
1. Medical records;
2. Records of laboratory tests; and
3. Any other information that VaCARES considers necessary to:
a. Determine final outcomes of abnormal CCHD screening results; or
b. Evaluate CCHD screening activities in the Commonwealth, including performance of follow-up evaluations and diagnostic tests, initiation of treatment when necessary, and surveillance of the accuracy and efficacy of the CCHD screening.
C. Information that the Virginia Department of Health receives under this section is confidential and may only be used or disclosed:
1. For research and collective statistical purposes pursuant to § 32.1-67.1 of the Code of Virginia;
2. For state or federally mandated statistical reports;
3. To ensure that the information received by the Virginia Department of Health is accurate and reliable; or
4. For reporting to the Virginia Congenital Anomalies Reporting and Education System pursuant to § 32.1-69.1 of the Code of Virginia and 12VAC5-191-280. The Newborn Screening Program shall refer the newborn's parent or guardian to the Care Connection for Children network for care coordination services.
D. The hospital administrator shall ensure that CCHD screening is included in the perinatal quality assurance program and provide the results of the quality improvement program to the Virginia Department of Health upon request.
A. In the instance of parent or guardian refusal of the CCHD screening based on religious practices or tenets, the parent or guardian refusal shall be documented on a refusal form provided by the Virginia Department of Health and made a part of the newborn's medical record.
B. The administrator of the hospital shall ensure that the Newborn Screening Program at the Virginia Department of Health is notified in writing of the parent or guardian refusal within five days of the newborn's birth.
The following words and terms when used in this regulation shall have the following meanings unless the context clearly indicates otherwise:
"Abnormal screening results" means all results that indicate the newborn has not passed the CCHD screening.
"Attending physician" means the physician in charge of the infant's care.
"Board" means the State Board of Health.
"Care Connection for Children" means a statewide network of centers of excellence for children and youth with special health care needs (CYSHCN) that provides leadership in the enhancement of specialty medical services, care coordination, medical insurance benefits evaluation and coordination, management of the CYSHCN pool of funds, information and referral to CYSHCN resources, family-to-family support, and training and consultation with community providers on CYSHCN issues.
"Care coordination" means a process that links individuals and their families to services and resources in a coordinated effort to maximize their potential and provide them with optimal health care.
"Chief administrative officer" means the individual appointed by the governing body to act in its behalf in the overall management of the hospital, or the Chief administrative officer’s designee. Job titles may include chief executive officer, administrator, superintendent, director, executive director, president, vice president, and executive vice president.
"Child" means a person less than 18 years of age and includes a biological or an adopted child, as well as a child placed for adoption or foster care unless otherwise treated as a separate unit for the purposes of determining eligibility and charges under these regulations.
"Commissioner" means the State Health Commissioner or the Commissioner’s designee.
"Critical congenital heart disease" or "CCHD" means a congenital heart disease that places a newborn at significant risk of disability or death if not diagnosed and treated soon after birth. The disease may include a defect such as hypoplastic left heart syndrome, pulmonary atresia (with intact septum), tetralogy of fallot, total anomalous pulmonary venous return, transposition of the great arteries, tricuspid atresia, or truncus arteriosus.
"CCHD Newborn Screening Program" means the Critical Congenital Heart Disease Newborn Screening Program within the Virginia Department of Health, that provides services including education, follow up, referral, and program evaluation.
"CCHD screening" means the application of screening technology to detect CCHD.
"Department" means the Virginia Department of Health.
"Echocardiogram" means a test that uses an ultrasound to provide an image of the heart.
"Guardian" means a parent-appointed, court-appointed, or clerk-appointed guardian of the person.
"Hospital" means any facility as defined in § 32.1-123 of the Code of Virginia.
"Licensed practitioner" means a licensed health care provider who is permitted, within the scope of his practice pursuant to Chapter 29 (§ 54.1-2900 et seq.) or Chapter 30 (§ 54.1-3000 et seq.) of Title 54.1 of the Code of Virginia, to provide care to a newborn.
“Negative(pass)” means a CCHD screening test result where the pulse oximetry value is 95% or more in the right hand and either foot and there is a difference of 3% or less between the pulse oximetry value in the right hand and the pulse oximetry value in a foot.
"Newborn" means an infant who is 28 days old or less who was born in Virginia.
"Parent" means a biological parent, adoptive parent, or stepparent.
"Physician" means a person licensed to practice medicine or osteopathic medicine in the Commonwealth pursuant to Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia and in accordance with applicable regulations.
“Positive(fail)” means a CCHD screening test result where the pulse oximetry value is 89% or less in either the right hand or either foot.
"Resident" means an individual who resides within the geographical boundaries of the Commonwealth.
"Screening technology" means pulse oximetry testing in the right hand and either foot. Screening technology shall also include alternate medically accepted tests that measure the percentage of blood oxygen saturation, follow medical guideline consensus and recommendations issued by the American Academy of Pediatrics, and are approved by the State Board of Health.
"Specialty level nursery" means the equivalent of the definition for Level II defined in Levels of Neonatal Care, written by the American Academy of Pediatrics Committee on Fetus and Newborn.
"Subspecialty level nursery" means the equivalent of the definitions for Levels III and IV defined in Level of Neonatal Care, written by the American Academy of Pediatrics Committee on Fetus and Newborn.
A. A hospital shall develop and implement protocols for:
1. CCHD screening in accordance with this chapter and modeled after national recommendations from the American Academy of Pediatrics regarding CCHD screening;
2. CCHD screening in specialty level nurseries and subspecialty level nurseries, modeled after national recommendations from the American Academy of Pediatrics regarding CCHD screening;
3. Physical evaluation by licensed practitioners of newborns with abnormal screening results; and
4. Referral of newborns with abnormal screening results, if needed, after evaluation.
A. Except as specified in subsection B of this section and in 12VAC5-72-70, a licensed practitioner shall perform the CCHD screening using pulse oximetry on every newborn in the birth hospital between 24 and 48 hours after birth, or if the newborn is discharged from the hospital fewer than 24 hours after birth, as late as practical before discharge.
B. If CCHD screening using pulse oximetry is not performed, the licensed practitioner shall document the reason in the newborn's medical record. The reasons include:
1. The newborn's current clinical evaluation includes an echocardiogram that ruled out CCHD;
2.The newborn has confirmed CCHD;
3.The newborn is under the care of a specialty level or subspecialty level nursery, in which case the screening shall be performed in accordance with the specific protocols developed pursuant to subdivision A 2 of 12VAC5-72-20; or
4. The parent or guardian refuses CCHD screening on the basis of religious practices or tenets.
A. A licensed practitioner shall record the CCHD screening results in the newborn's medical record.
B. The hospital shall enter the CCHD screening results into the electronic birth certificate system with the following information:
1. CCHD screening completed, CCHD negative(pass) or positive(fail), and pulse oximetry values, if applicable; or
2. Not screened pursuant to subdivision B 4 of 12VAC5-72-30.
C. If the results of the CCHD screening are abnormal:
1. The licensed practitioner who conducted the screening shall immediately report the results to the attending physician or the physician’s designee;
2. An attending physician or the physician’s designee shall evaluate the newborn according to the timeframes within the hospital protocol developed pursuant to 12VAC5-72-20; and
3. The hospital may not discharge the newborn until:
a. An attending physician has determined a cause for the abnormal screening result and a plan is in place for immediate evaluation at another medical facility; or
b. A licensed practitioner has performed, and a physician has read, an echocardiogram and an appropriate clinical plan has been developed.
4. The hospital shall enter a diagnosis arising from abnormal screening results into the electronic birth certificate system.
5. The attending physician or the physician’s designee shall provide notification of abnormal screening results and any diagnoses to the newborn's parent or guardian and to the primary care provider who is in charge of the newborn's care after the newborn leaves the hospital.
A. For any child diagnosed under 12VAC5-72-10 through 12VAC5-72-60, the chief administrative officer of every hospital shall make or cause to be made a report to the Commissioner in accordance with § 32.1-69.1 of the Code of Virginia.
B. Upon receiving the notification described in subsection A of this section, the CCHD Newborn Screening Program at the department shall refer the child to the Care Connection for Children network for care coordination services as necessary.
A. Upon request, a hospital shall make available to the CCHD Newborn Screening Program at the department:
1. Medical records;
2. Records of laboratory tests; and
3. Other information that the CCHD Newborn Screening Program at the department considers necessary to:
a. Determine final outcomes of abnormal CCHD screening results; or
b. Evaluate CCHD screening activities in the Commonwealth, including performance of follow-up evaluations and diagnostic tests, initiation of treatment when necessary, and surveillance of the accuracy and efficacy of the CCHD screening.
A. If a parent or guardian refuses the CCHD screening based on religious practices or tenets, the licensed practitioner shall document the refusal on the Notification of Parental Refusal of Dried-Blood Spot and Critical Congenital Heart Disease Screening form and document the refusal in the newborn's medical record.
B. The hospital shall ensure that the CCHD Newborn Screening Program at the department is notified in writing of the refusal within five days of the newborn's birth.
A. The Care Connection for Children network shall provide:
1. Care coordination services for residents of the Commonwealth who are diagnosed with CCHD and referred to the network by the CCHD Newborn Screening Program at the department; and
2. Other network services for eligible individuals in accordance with § 32.1-77 of the Code of Virginia and applicable regulations.
B. The Care Connection for Children network shall, upon request, provide data to the CCHD Newborn Screening Program at the department.
A. The department's employees and contractors shall maintain, store, and safeguard client records from unauthorized access as required by law.
B. Information that the CCHD Newborn Screening Program at the department receives under this section is confidential and may only be used or disclosed:
1. For research and collective statistical purposes pursuant to § 32.1-67.1 of the Code of Virginia;
2. For state or federally mandated statistical reports;
3. To ensure that the information received by the CCHD Newborn Screening Program at the department is accurate and reliable;
4. To perform quality improvement and assurance activities including ensuring hospital reporting.