House committee substitute to the 2nd edition makes the following changes.
Makes the following changes to proposed Part 4A to Article 6 of GS Chapter 131E, Birth Center Licensure Act (Act).
Changes the effective date of the offense created by the Part making it unlawful for any person to resist proper entry by DHHS representatives upon any premises other than a private dwelling. Makes the offense effective December 1, 2019 (was, July 1, 2019), and applicable to offenses committed on or after that date.
Modifies the appointment provisions of NC Birth Center Commission (Commission) members, clarifying the appointment of members by the General Assembly upon the respective recommendations of the Speaker and the President Pro Tempore from among those elected by the NC Obstetrical and Gynecological Society and by the North Carolina Affiliate of the American College of Nurse-Midwives. Provides for vacancies to be filled in the same manner as the original appointment, except that unexpired terms that were legislatively appointed must be filled in accordance with GS 120-122 (previously, provided for the executive committee of specified organizations to fill vacancies until the organization nominates a member to fill the vacancy at its next meeting).
Eliminates the provisions requiring the Commission to notify a licensee within 60 days after confidential information is transmitted and include a summary of the information transmitted; requiring the Commission to allow the licensee to request a copy of the information transmitted within 30 days of notification; and prohibiting the provision of notice of copies pending ongoing criminal investigation by any law enforcement agency or Department of Health and Human Service (DHHS) personnel with enforcement or investigative responsibility.
Changes the effective date of the licensure requirements, adverse action provisions, and service limitations from July 1, 2019, to one year after the rules promulgated by the Commission are adopted. Concerning licensure requirements, raises the nonrefundable annual license fee to $400 (was, $100) and adds a nonrefundable annual pre-birthing room fee of $17.50. Adds new provisions to allow currently operating and accredited birthing centers to continue operations as the Commission is constituted and promulgates permanent rules. Requires those operating birth centers to submit completed applications and requisite fees to the Division of Health Service Regulation within 90 days of the effective date of the Commission's permanent rules regarding licensure applications. Requires the application and fee to be received or postmarked no later than 90 days after the rules are adopted. Concerning adverse actions on a license, authorizes the DHHS Secretary or a designee (previously, only the Secretary) to suspend the admission of any new patients to a birth center if the birth center conditions are detrimental to the health or safety of any patient (was, for substantial noncompliance with the provisions of new Part 4A or related rule and dangerous to any patient; also, previously authorized the Secretary to suspend services of the birth center). Eliminates the factors the Secretary was required to consider before suspending admissions. Establishes that the suspension is effective until the Secretary or a designee is satisfied that the conditions or circumstances merit its removal. Further, clarifies that this authority is in addition to the authority to suspend or revoke the license of the birth center.
Adds a new statute to the Part to make it a Class 3 misdemeanor to operate a birth center without a license, punishable by a fine of up to $50 for the first offense and up to $500 for each subsequent offense. Specifies that each day of continuing violation after conviction is considered a separate offense. Effective one year after the rules promulgated by the Commission are adopted.
Adds a directive for DHHS to develop a birth center licensure application consistent with the Part's requirements and make it available upon the adoption of the rules by the Commission.
Makes further clarifying and technical changes. Changes the act's effective date to the date the act becomes law (was, July 1, 2019), except as otherwise provided.
Summary date: Jun 26 2019 - More information
Summary date: Apr 30 2019 - More information
House committee substitute to the 1st edition makes the following changes.
Makes the following changes to proposed Part 4A to Article 6 of GS Chapter 131E, Birth Center Licensure Act (Act).
Excludes ambulatory surgical facilities from the definition of birth center.
Modifies the appointment provisions of NC Birth Center Commission (Commission) members, providing for appointment of six members by the Governor, and the Speaker or the President Pro Tempore from among those elected by the NC Obstetrical and Gynecological Society and the NC Affiliate of the American College of Nurse-Midwives, as specified. Specifies that the seventh member appointed by the Governor must be ineligible for appointment under the other appointment provisions and must have professional experience and familiarity with the administrative aspects of obstetrical care practices and facilities, including birth centers. Establishes four-year terms for members and prohibits serving for more than two consecutive terms. Requires initial appointments be made no later than 60 days after the effective date of the act. Provides for staggered terms. Specifies that partial terms of initial members for staggering member terms do not count as full terms for purposes of the term limitations.
Concerning the Commission's duty to adopt rules establishing birth center licensure requirements, requires the rules to require each licensed birth center to report certain unexpected occurrences and adverse outcomes to the Commission for the Accreditation of Birth Centers and the Department of Health and Human Services (Department) within a timeframe established by the Commission, rather than within 15 days after the occurrence.
Adds a new statute to the proposed Part to authorize the Commission, its members, and staff to release confidential or nonpublic information to any health care licensure board or DHHS personnel with relevant enforcement or investigative responsibilities. Requires the Commission to notify a licensee within 60 days after the information is transmitted and include a summary of the information transmitted. Allows the licensee to request a copy of the information transmitted within 30 days of notification. Prohibits the provision of notice of copies pending ongoing criminal investigation by any law enforcement agency or DHHS personnel with enforcement or investigative responsibility.
Specifies that the act applies to licenses granted one year after the rules promulgated by the Commission are adopted. Directs the Codifier of Rules to notify the Revisor of the effective date of the rules.
Summary date: Apr 3 2019 - More information
Enacts new Part 4A to Article 6 of GS Chapter 131E, titled the Birth Center Licensure Act (Act).
Sets out the purpose of the Act and defines terms. Prohibits the establishment or operation of a birth center in the state without first obtaining a license from the Department of Health and Human Services (DHHS) pursuant to new Part 4A. Defines birth center as a facility licensed for the primary purpose of performing normal, uncomplicated deliveries that is not a hospital, and where births are planned to occur away from the mother's usual residence following a low-risk pregnancy, as that term is defined. Requires DHHS to provide applications for licensure and details the information required to be included in applications. Directs DHHS to issue a license upon the recommendation of the NC Birth Center Commission (Commission) if it finds the applicant is in compliance with the provisions of Part 4A and any rules adopted by the Commission. Provides that the license is valid for one year and is required to designate the number of beds and the number of rooms on the licensed premises. Establishes a $100 nonrefundable annual license fee to be credited to DHHS as a departmental receipt and applied to offset costs for licensing and inspecting birth centers. Provides for license renewal by DHHS pursuant to rules adopted by the Commission. Establishes that a license is not transferable or assignable except with written approval of DHHS. Requires operators to post the license on the licensed premises in an area accessible to the public.
Authorizes the denial, suspension, or revocation of a license for substantial failure to comply with the provisions of Part 4A or rules adopted by the Commission. Provides five factors the DHHS Secretary must consider in determining whether to suspend admissions or services when the birth center's conditions are dangerous to the health or safety of the patients, including whether all other reasonable means of correcting the problem have been exhausted and no less restrictive alternative to suspension of admissions or services exists. Provides for a birth center to contest any adverse action on its license in accordance with GS Chapter 150B (APA).
Prohibits a licensed birth center from representing or providing services outside of the scope the license. Sets the following limitations on services at a licensed birth center: (1) surgical procedures must be limited to those normally accomplished during an uncomplicated birth, (2) no abortions can be performed, (3) no general or conduction anesthesia can be performed, and (4) no vaginal birth after cesarean or trial of labor after cesarean can be performed.
Requires DHHS to review and, as necessary, revise the Freestanding Birth Center Fee Schedule every three years to ensure that the fees are sufficient to cover the costs of services and that the cost for any State-mandated newborn screening is reimbursed at least at cost.
Directs DHHS to inspect birth centers as it deems necessary to investigate unexpected occurrences involving death or serious physical injury and reportable adverse outcomes identified in the rules adopted by the Commission. Requires all licensed birth centers be subject to DHHS inspections at all times. Provides for access to licensed premises by authorized DHHS representatives. Makes it unlawful for any person to resist proper entry by authorized DHHS representatives upon premises other than a private dwelling. Prohibits those representatives from endangering the health or well-being of any patient being treated in the birth center by his or her entry onto the premises. Grants DHHS the authority to investigate birth centers in the same manner as it investigates hospitals under GS 131E-80(d). Permits public disclosure of information received by the Commission or DHHS through filed reports, license applications, or inspection required or authorized by new Part 4 except where disclosure would violate applicable laws concerning patient records and confidentiality. Prohibits disclosure from identifying the patient involved without permission of the patient or court order.
Creates the seven-member NC Birth Center Commission of DHHS. Specifies the powers and duties of the Commission, including adopting rules establishing standards for licensure, operation, and regulation of birth centers in the State. Details the Commission membership. Provides parameters for vacancies, removal, and member expenses, as well as Commission quorum and the provision of clerical services.
Requires the Commission to adopt rules establishing seven licensure requirements, including: (1) a requirement that the birth center obtain and maintain accreditation with the Commission for the Accreditation of Birth Centers (CABC), and including several documentation and reporting requirements; (2) a requirement that the birth center establish procedures specifying the criteria by which each person's risk status will be evaluated at admission and during labor, pursuant to CABC standards; and (3) a requirement that the birth center develop and submit a plan for complying with the standards of CABC with respect to transfer of care procedures. Requires DHHS to enforce the provisions of new Part 4 and any rules adopted by the Commission.
Directs DHHS to, by October 1, 2019, review, and as necessary, revise, its current Freestanding Birth Center Fee Schedule to ensure that the fees are sufficient to cover the costs of services and that the cost for any State-mandated newborn screening is reimbursed at least at cost.
Effective July 1, 2019.
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