W. Va. Code R. § 69-9-4

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 69-9-4 - STATE OVERSIGHT AGENCY AUTHORITY; POWERS AND DUTIES

4.1. The Secretary has designated the Office of Health Facility Licensure and Certification within the Department of Health and Human Resources to act as the state oversight agency, as defined in this rule.

4.2. The Office of Health Facility Licensure and Certification shall provide regulatory oversight, licensing and inspection of neonatal abstinence syndrome centers.

4.3. The duties and powers of the state oversight agency include, but are not limited to, the following:

4.3.a. Develop and implement rules, standards, and best practice guidelines regarding the licensure and oversight of neonatal abstinence syndrome centers;

4.3.b. Accept applications and fees for the licensure of neonatal abstinence syndrome centers;

4.3.c. Conduct all necessary reviews, inspections or investigations in order to determine whether a license should be issued or renewed;

4.3.d. Issue initial, amended and renewed licenses to neonatal abstinence syndrome centers upon a determination that the program is qualified;

4.3.e. Deny initial, amended and renewed licenses to neonatal abstinence centers upon the determination that the program is not qualified;

4.3.f. Perform annual inspections, revisits and complaint investigations as unannounced surveys when necessary and appropriate;

4.3.g. Monitor activities of all neonatal abstinence syndrome centers to ensure compliance with all state requirements;

4.3.h. Receive and act upon patient complaints, appeals and grievances;

4.3.i. Inspect all allegations of misconduct, rule or regulation violations, unauthorized activities or other conduct that may affect the health, safety or well-being of patients or employees of a neonatal abstinence syndrome center;

4.3.j. Issue a directed plan of correction when a neonatal abstinence facility fails to develop an acceptable plan of correction;

4.3.k. Revoke or suspend the license of a neonatal abstinence syndrome center in accordance with the applicable administrative proceedings; and

4.3.l. Perform all other necessary actions related to the licensing, monitoring, investigatory and oversight of neonatal abstinence syndrome centers.

4.4. Annual Inspections.

4.4.a. Each neonatal abstinence syndrome center shall be inspected annually by the oversight state agency. Inspections shall include, but are not limited to:

4.4.a.1. Observations of service delivery;

4.4.a.2. Review of life safety and environmental conditions;

4.4.a.3. Review of clinical and administrative records;

4.4.a.4. Review of policies and procedures;

4.4.a.5. Review of employee and volunteer personnel files, criminal background checks, qualifications, staff education and staff training; and

4.4.a.6. Interviews with staff, administrators, volunteers, families, and legal representatives.

4.4.b. The neonatal abstinence syndrome center shall comply with any reasonable requirements from the state oversight agency with access, in a timely manner, to the facility, personnel, records, patients, and/or family/legal representatives to conduct annual inspection activities.

4.4.c. Within 10 working days of the completion of the inspection, the state oversight agency shall issue a written report to the center. The written report or statement of deficiencies will detail the findings of the annual inspection, and a determination of compliance.

4.4.d. The state oversight agency may permit the neonatal abstinence syndrome center to develop a plan of correction based on the finding of the statement of deficiencies.

4.4.e. Based upon the neonatal abstinence center's previous substantial compliance with this rule, and the current inspection report, the state oversight agency may waive the requirement for an onsite inspection for issuance of an amended license.

4.5. For Cause Inspections and Complaints.

4.5.a. The state oversight agency may at any time inspect a neonatal abstinence syndrome center for cause upon a complaint or a reasonable suspicion the facility is operating in violation of this rule.

4.5.b. Any person may file a complaint with the state oversight agency alleging a violation of applicable laws, rules, or policies by a neonatal abstinence center.

4.5.c. The state oversight agency may conduct unannounced inspections of a neonatal abstinence center named in a complaint and any other inquiries deemed necessary to determine the validity of a complaint.

4.5.d. At the time of any on-site investigation activities, the state oversight agency shall notify the program sponsor or administrator of the general reason for the investigation.

4.5.e. Within 10 working days of the completion of the investigation, the state oversight agency shall provide the program sponsor or administrator a written report of the results of the investigation. The report shall specify any deficiency found and the provisions of this rule that forms the basis for the violation.

4.5.f. The state oversight agency may permit the neonatal abstinence center to develop a plan of correction to address any cited violations or deficiencies.

4.5.g. The state oversight agency may issue a directed plan of correction to the center for implementation by the neonatal abstinence center to correct any violations or deficiencies.

4.5.h. The state oversight agency shall keep confidential any information that could reasonably lead to the identification of a complainant and of any patient involved in the complaint or investigation. The state oversight agency shall not disclose such information without the written consent of the complainant. Any identifying information shall be deleted before disclosure of the investigative information to the public.

4.6. Plans of Correction.

4.6.a. Within 10 working days of the completion of the inspection, the state oversight agency shall issue a written report to the center. The written report or statement of deficiencies will detail the findings of the annual inspection, and a determination of compliance.

4.6.b. The state oversight agency may permit the neonatal abstinence syndrome center to develop a plan of correction based on the finding of the statement of deficiencies.

4.6.c. The state oversight agency may issue a directed plan of correction for implementation by the neonatal abstinence syndrome center to correct any violations or deficiencies.

4.6.d. Within 10 working days after receipt of the inspection report, program sponsor or administrator shall submit to the state oversight agency for approval a written plan of correction for all deficiencies cited in an initial, provisional, renewal, complaint, or revisit survey. The plan of correction shall specify:

4.6.d.1.Any action taken or procedures proposed to correct the deficiencies and prevent their reoccurrence;

4.6.d.2. The date of completion of each action taken or to be taken; and

4.6.d.3. The signature of the head of the governing body or his or her designee.

4.6.e. The neonatal abstinence center shall correct all deficient practices cited during a survey.

4.6.e.1. The facility must take immediate steps to correct a deficient practice that poses an immediate jeopardy to the health or safety of a patient or other person.

4.6.e.2. The facility must identify a completion date for each correction. This completion date shall be within a time period that allows for the correction of the deficient practice.

4.6.f. The proposed plan of correction shall be approved, modified or rejected by the state oversight agency in writing.

4.6.f.1. The state oversight agency shall determine if the satisfactory corrections have been made and advise the program sponsor in writing of any compliance or continued deficiencies.

4.6.f.2. The state oversight agency shall state the reasons for rejection or modification of any plan of correction.

4.6.g. The neonatal abstinence center shall submit a revised plan of correction to the state oversight agency within 10 working days of receipt of a rejection by the state oversight agency.

4.6.h. The state oversight agency may conduct an onsite revisit to determine compliance with the plan of correction.

4.7. Penalties.

4.7.a. The state oversight agency may impose a fine, suspend or revoke a license or take other action as deemed appropriate to address any violations or deficiencies.

4.7.b. The state oversight agency may suspend or revoke a license of any neonatal abstinence center for violating the prohibition of this rule.

4.7.c. The state oversight agency may deny any application for licensure or licensure renewal as a neonatal abstinence syndrome center; revoke or suspend a license; and/or order an admissions ban or reduction in patient census for one or more of the following reasons:

4.7.c.1. The state oversight agency makes a determination that fraud or other illegal action has been committed;

4.7.c.2. The state oversight agency has violated federal, state or local law relating to building, health, fire protection, safety, sanitation or zoning;

4.7.c.3. The neonatal abstinence syndrome center conducts practices that jeopardize the health, safety, welfare or clinical treatment of a patient;

4.7.c.4. The neonatal abstinence center has failed or refused to submit reports or make records available as requested by the state oversight agency; or

4.7.c.5. The neonatal abstinence center has refused to provide access to its facility or records as requested by the state oversight agency.

4.7.d. If a license for a neonatal abstinence center has been revoked, the state oversight agency may stay the effective date of the revocation if the program can show that the stay is necessary to ensure appropriate referral and placement of patients.

4.8. Informal Dispute Resolution.

4.8.a. The Director shall offer a neonatal abstinence syndrome center an opportunity for an informal dispute resolution process to contest a cited deficiency.

4.8.b. The neonatal abstinence syndrome center shall submit a request for an informal dispute resolution to the state oversight agency with the plan of correction.

4.8.c. The request for an informal dispute resolution must be received within 10 working days of receipt of the inspection or investigation report.

4.8.d. The state oversight agency will maintain policies and procedures for conducting informal dispute resolutions.

4.8.e. If the neonatal abstinence syndrome center is successful in demonstrating the disputed deficiencies should not have been cited, the Director shall remove the deficiencies from the inspection or investigation report, and rescind any penalties imposed solely as a result of those disputed deficiencies.

4.8.f. All communications during an informal dispute resolution are confidential and cannot be used by or against the licensee or the state oversight agency in the event a formal hearing takes place.

4.8.g. Neither party is entitled to representation during the informal dispute resolution process.

4.9. Inspection Reports and Records.

4.9.a. Neonatal Abstinence Center Responsibilities.

4.9.a.1. The center shall make the results of the surveys and inspections, as well as plans of correction, available for examination in a place readily accessible.

4.9.a.2. The center shall post a notice of the availability of the survey and inspection reports in a place readily accessible to patients and visitors.

4.9.a.3. Any person shall have the right to review the most recent and past state inspection and complaint reports with the plan of correction.

4.9.b. State Oversight Agency Responsibilities.

4.9.b.1. The state oversight agency shall keep on file a report of any inspection, survey, investigation of any neonatal abstinence syndrome center or any program sponsor, owner, employee, volunteer or patient thereof in accordance with the Department's record retention policy.

4.9.b.2. The information in reports or records shall be available to the public except for the following:

4.9.b.2.A. Information regarding complaints and subsequent investigations that is deemed confidential by any provision of this rule or applicable state or federal laws;

4.9.b.2.B. Information of a personal nature from a patient or personnel file; or

4.9.b.2.C. Information required to be kept confidential by state or federal law.

4.9.b.3. The Director shall make available for public inspection and, upon request, provide hard copies at a cost of $0.25 per page or electronically at a nominal cost, of the following documents:

4.9.b.3.A. Applications and exhibits;

4.9.b.3.B. Inspection reports;

4.9.b.3.C. Reports of investigations conducted in response to complaints; and

4.9.b.3.D. Any other report filed with or issued by the Director pertaining to the compliance of a neonatal abstinence center with applicable laws and rules.

4.9.b.4. If the Director determines it is in the best interest of the public, the Director may provide copies of records and reports free of charge to nonprofit community organizations upon written request.

4.9.b.5. The Director shall treat a report of inspection of a center as public information from the time an acceptable plan of correction is submitted.

4.9.b.6. If the center does not submit a written plan of correction, or a written plan of correction is not required within the time specified by the Director pursuant to this rule, reports pertaining to the center shall be made public at the expiration of the specified time.

4.9.b.7. Other records and reports shall be treated as public information from the time they are submitted to or issued by the Director.

4.9.b.8. 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 patient.

4.10. Interpretive Guidelines. The state oversight agency may issue interpretive guidelines related to this rule and prior to the adoption and implementation of the guidelines, shall provide notice of a public comment period to all affected parties.

W. Va. Code R. § 69-9-4