wv-wv-18537: 64-100 — PULSE OXIMETRY NEWBORN TESTING

6/25/2026 2:28:28 PM Office of West Virginia Secretary Of State NOTICE OF PUBLIC COMMENT PERIOD AGENCY: Health TITLE-SERIES: 64-100 RULE TYPE: Legislative Amendment to Existing Rule: No Repeal of existing rule:Yes RULE NAME: PULSE OXIMETRY NEWBORN TESTING CITE STATUTORY AUTHORITY: WV Code §§16-44-1 and 16-44-2 COMMENTS LIMITED TO: Written DATE OF PUBLIC HEARING: LOCATION OF PUBLIC HEARING: DATE WRITTEN COMMENT PERIOD ENDS: 07/25/2026 5:00 PM COMMENTS MAY BE MAILED OR EMAILED TO: NAME: Virginia M Payne 321 Capitol Street ADDRESS: Charleston, WV 25301 EMAIL: virginia.m.payne@wv.gov PLEASE INDICATE IF THIS FILING INCLUDES: No RELEVANT FEDERAL STATUTES OR REGULATIONS: (IF YES, PLEASE UPLOAD IN THE SUPPORTING DOCUMENTS FIELD) INCORPORATED BY REFERENCE: No (IF YES, PLEASE UPLOAD IN THE SUPPORTING DOCUMENTS FIELD) PROVIDE A BRIEF SUMMARY OF THE CONTENT OF THE RULE: This rule which implements the Pulse Oximetry Newborn Testing Act requires testing and provides timing requirements for such testing. SUMMARIZE IN A CLEAR AND CONCISE MANNER CONTENTS OF CHANGES IN THE RULE AND A STATEMENT OF CIRCUMSTANCES REQUIRING THE RULE: This rule is being repealed in its entirety and combined with 64CSR91. SUMMARIZE IN A CLEAR AND CONCISE MANNER THE OVERALL ECONOMIC IMPACT OF THE PROPOSED RULE: A. ECONOMIC IMPACT ON REVENUES OF STATE GOVERNMENT: None B. ECONOMIC IMPACT ON SPECIAL REVENUE ACCOUNTS: None C. ECONOMIC IMPACT OF THE RULE ON THE STATE OR ITS RESIDENTS: None D. FISCAL NOTE DETAIL: Effect of Proposal Fiscal Year 2026 2027 Fiscal Year (Upon Increase/Decrease Increase/Decrease Full (use "-") (use "-") Implementation) 1. Estimated Total Cost 0 0 0 Personal Services 0 0 0 Current Expenses 0 0 0 Repairs and Alterations 0 0 0 Assets 0 0 0 Other 0 0 0 2. Estimated Total 0 0 0 Revenues E EXPLANATION OF ABOVE ESTIMATES (INCLUDING LONG-RANGE EFFECT): N/A BY CHOOSING 'YES', I ATTEST THAT THE PREVIOUS STATEMENT IS TRUE AND CORRECT. Yes Virginia M Payne-By my signature, I certify that I am the person authorized to file legislative rules, in accordance with West Virginia Code §29A-3-11 and §39A-3-2. 64CSR100 TITLE 64 LEGISLATIVE RULE BUREAU FOR PUBLIC HEALTH DEPARTMENT OF HEALTH AND HUMAN RESOURCES SERIES 100 PULSE OXIMETRY NEWBORN TESTING §64-100-1. General. 1.1. Scope -- This rule which implements the Pulse Oximetry Newborn Testing Act requires testing and provides timing requirements for such testing. This rule s hould be read in conjunction with WV Code §16-44-1 and §16-44-2. The WV Code is available in public libraries and on the Legislature’s web page, http://www.legis.state.wv.us/. 1.2. Authority -- WV Code §§16-44-1 and 16-44-2. 1.3. Filing Date -- July 12, 2013. 1.4. Effective Date -- August 12, 2013. §64-100-2. Application. 2.1. Application -- This rule applies to all birthing facilities licensed by the Department of Health and Human Resources that provide birthing services and newborn care services. §64-100-3. Definitions. 3.1. Birthing Facility – An inpatient or ambulatory health care facility licensed by the Department of Health and Human Resources that provides birthing and newborn care services. 3.2. Commissioner – The Commissioner of the Bureau for Public Health or his or her authorized representative. 3.3. Congenital Heart Defects (CHD) - Structural abnormalities of the heart that are present at birth. Some critical congenital heart defects can cause severe and life-threatening symptoms which require intervention within the first days of life. 3.4. Pulse Oximetry Testing - A noninvasive test that estimates the percentage of hemoglobin in blood that is saturated with oxygen. §64-100-4. Responsibilities of Birthing Facilities. 4.1. A birthing facility shall cause to be performed a pulse oximetry screening on every newborn in its care. 4.2. The pulse oximetry screening shall be performed when the newborn is twenty-four to forty-eight hours of age, or as late as possible if the newborn is to be discharged from the facility before he or she is twenty-four hours of age. 1 4.3. The pulse oximetry screening results shall be recorded on the newborn’s Birth Score sheet or through an alternate means of data collection that has been approved by the Commissioner. §64-100-5. Recommended Protocol for Pulse Oximetry Testing. 5.1. The following are recommendations from the United States Secretary of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children, the American Academy of Pediatrics, and the Centers for Disease Control and Prevention. 5.2. Pulse oximetry should be performed on the right hand and one foot. If the newborn’s oxygen saturation is > 95% in either extremity, with a < 3% difference between the two, he or she will be considered to have passed the screening test and no additional evaluation will be required unless signs or symptoms of CHD are present. 5.3. If the oxygen saturation is <95% in both the hand and foot or there is a >3% difference between the hand and foot on three measures, each separated by one hour, the newborn should be evaluated by his or her pediatrician and referred, if indicated, for an echocardiogram at an ultrasound facility that has experience in newborn cardiac echocardiograms. The echocardiogram shall be interpreted by a pediatric cardiologist who shall then make appropriate arrangements for follow-up when necessary. 5.4. A newborn with oxygen saturation that is <90% in either the hand or foot should be referred immediately for additional evaluation. 5.5. The pulse oximetry guidelines and supporting information may be found online at http:/www.wvdhhr.org/mcfh. §64-100-6. Confidentiality. The pulse oximetry screening results recorded on the birth score sheet or other data reporting form are confidential and shall not be released or disclosed to anyone other than the child, his or her parents, guardian or representatives for any reason other than data analysis and planning purposes by public health officials. §64-100-7. Administrative Due Process. Any persons adversely affected by the enforcement of this rule desiring a contested case hearing to determine any rights, duties, interests or privileges shall do so in a manner prescribed in the bureau for public health's rule, Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1. 2