Current through Register Vol. XLI, No. 36, September 6, 2024
Section 64-31-5 - State Administrative Procedures5.1. General Licensure Provisions 5.1.1. No person, partnership, association, corporation, or any local governmental unit or any division, department, board or agency thereof may operate a birthing center in the State of West Virginia without first obtaining a license under these rules.5.1.2. Neither an original nor a renewal license shall be issued under these rules for a project reviewable under Chapter 16, Article 2D of the West Virginia Code of 1931, as amended, unless the state health planning and development agency has issued a finding, after a final conformance review, that the completed project conforms to the terms of the certificate of need decision issued for the project. Evidence of compliance shall be supplied with licensure applications.5.1.3. A license shall be valid only for the premises and persons named and described in the application, shall not be transferable or assignable and shall be surrendered to the director upon written demand stating the cause for the demand.5.1.4. If the ownership of a birthing center with a valid unexpired license changes, the new owner shall apply for a new license. The application of the new owner for a license shall have the effect of a valid license for three months from the date the application is received by the director.5.1.5. A license shall state: (a) the specific name of the birthing center to which it applies; (b) the date of issuance; and (c) the expiration date. A birthing center name change shall be shown in the next license issued.5.1.6. The license shall be posted in a conspicuous and public place of the birthing center.5.1.7. Neither the name of the birthing center nor any advertising of the center's services shall suggest or claim any services other than those given on the application and for which the center is licensed.5.2. Initial License5.2.1. An applicant shall submit a completed application to the director, on a form prescribed by the director, not less than thirty days and not more than sixty days prior to the date proposed for commencement of operation. Information required may include affirmative evidence of ability to comply with these rules and regulations. A nonrefundable fee of ten dollars ($10) shall be submitted with the application for an initial license.5.2.2. An initial license shall be issued only after the director inspects the birthing center and only if he or she finds that:(a) the birthing center substantially complies with these rules and regulations; and(b) the applicant is a person responsible and suitable to operate, direct or participate in the operation of a birthing center by virtue of financial capacity and appropriate business or professional experience.5.2.3. An initial license issued after the effective date of these rules and regulations shall be valid for a period of one year from the date of issuance.5.3. Renewal License 5.3.1. An applicant for a renewal license shall submit a completed application to the director on a form prescribed by the director not less than thirty days and not more than ninety days prior to the scheduled expiration date of the current license. A nonrefundable fee of ten dollars ($10) shall be submitted with the license renewal application.5.3.2. The director shall issue a renewal license when he or she finds the facility in compliance with these regulations and the licensee submits a completed application and the correct renewal fee.5.3.3. A renewal license shall be valid for a period of one year from the date of issuance.5.4. Provisional License 5.4.1. If the director finds that an applicant for a renewal license is not in substantial compliance with the requirements of these regulations the director may, in his or her discretion, issue a provisional license.5.4.2. A provisional license may be issued only when the director finds that: (a) the care given in the birthing center is adequate to meet client needs; and (b) the birthing center has demonstrated improvement in and potential for substantial compliance within the term of the license for which renewal is requested.5.4.3. A provisional license shall not be issued for a period greater than twelve months; shall not be renewed; and shall not be issued to a facility with uncorrected violations of these regulations which would pose an imminent danger to the health and safety of any client.5.5. Inspections 5.5.1. The director shall conduct at least one unannounced inspection annually of a licensed birthing center to determine compliance with the provisions of these regulations.5.5.2. The director shall have the right to enter the premises of a facility which he or she has reason to believe is being operated or maintained as a birthing center without a license.5.5.3. If the owner or person in charge of a licensed birthing center or of an unlicensed facility which the director has reason to believe is being operated as a birthing center refuses entry pursuant to these regulations, the director shall take action to secure a lawful warrant authorizing inspection.5.5.4. If the director finds on the basis of the inspection that a facility is operating as a birthing center without a license, the facility shall apply within ten days for a license in accordance with the provisions of these regulations.5.5.5. Failure to apply for a license shall be subject to the penalties established by Chapter 16, Article 2E, Section 5 of the West Virginia Code of 1931, as amended.5.5.6. A report of any inspection made pursuant to these regulations shall be made in writing and shall be maintained on file by the director.5.5.7. Inspection reports shall specifically list each deficiency in the birthing center's compliance with statutes and rules and regulations.5.5.8. The director shall send a copy of a report of an inspection to the birthing center.5.6. Plans of Correction 5.6.1. A birthing center found on the basis of an inspection to have deficiencies in compliance with these rules and regulations shall develop a plan of correction and submit it to the director within thirty days of receipt of the inspection report.5.6.2. A plan of correction shall specify a reasonable time within which the birthing center shall correct each violation cited in the report, which time shall be the shortest possible time within which the birthing center reasonably can be expected to correct the violation.5.6.3. The time stated shall be subject to approval or modification by the director. In determining whether to approve the time submitted by the facility, the director shall consider the following factors: (a) the seriousness of the violation; (b) the availability of required equipment or personnel; (c) the estimated time required for delivery and installation of required equipment; and (d) any other relevant circumstances.5.6.4. A plan of correction submitted by a birthing center shall be approved, modified or rejected by the director. The director shall notify the birthing center within ten (10) days as to whether a plan of correction has been approved, modified or rejected. If the director rejects or modifies the plan, the reasons for the action shall be stated. When the director rejects a plan of correction, a reasonable time for submission of a revised plan may be allowed.5.6.5. Upon the failure by a birthing center with deficiencies to submit a plan of correction which is approved by the director or to correct any deficiency within the time specified in an approved plan of correction, the director may initiate legal action available to him or her in accordance with the West Virginia Code of 1931, as amended, and these rules and regulations.5.7. Complaint Investigation 5.7.1. Any person may register a complaint with the director alleging violation of applicable laws or rules and regulations by the birthing center. A complainant shall state the substance of the complaint and shall identify the birthing center involved.5.7.2. The director may conduct either an announced or an unannounced inspection of the birthing center to determine the validity of the complaint. The department shall provide the birthing center with notice of the substance of the complaint only at the time of the inspection. The director shall conduct such other investigations as may be necessary to determine the validity of the complaint.5.7.3. The director shall notify the complainant and the birthing center in writing of the results of the investigation no later than twenty (20) working days after completing an investigation of a complaint.5.7.4. Upon written request, the director will send the complainant a description of the corrective action the birthing center will be required to take and of any disciplinary action to be taken.5.7.5. The name of a complainant or of any person named in a complaint shall be safeguarded by the director and shall not be disclosed without the individual's prior written authorization. Before any complaint is disclosed to a birthing center or to the public pursuant to these regulations, any information in the complaint which could reasonably identify the complainant or a client shall be deleted. If a complaint becomes the subject of a judicial proceeding, nothing in these rules and regulations shall be construed to restrict disclosure of information which would otherwise be disclosed in a judicial proceeding.5.8. Availability of Reports and Records 5.8.1. The director shall make available for public inspection and upon written request may provide copies of the following documents: (b) reports of investigations conducted in response to complaints; and (c) any other reports filed with or issued by the director pertaining to the compliance of a facility with applicable laws, rules and regulations. A fee may be charged to cover the cost of research and copying. Applications for initial and renewal license shall be held confidential.5.8.2. The director shall treat a report of inspection of a birthing center as public information from the time a written plan of correction is submitted.5.8.3. If the birthing center does not submit a written plan of correction within the time specified by the director pursuant to Section 5.7 of these regulations, reports pertaining to the birthing center shall be made public at the expiration of the specified time.5.8.4. Other records and reports shall be treated as public information from the time they are issued by the director.5.8.5. Nothing contained in this section shall be construed to require or permit the public disclosure of confidential medical, social, personal or financial records of any client.5.8.6. Before releasing a report or record deemed public information the director shall delete any confidential information which could reasonably permit identification of clients or of complainants or of any other information required to be held confidential under these rules and regulations.