West Virginia Code of State Rules
Agency 69 - Health And Human Resources
Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES
Series 69-09 - Neonatal Abstinence Centers
Section 69-9-4 - STATE OVERSIGHT AGENCY AUTHORITY; POWERS AND DUTIES
Universal Citation: 69 WV Code of State Rules 69-9-4
Current through Register Vol. XLI, No. 38, September 20, 2024
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.
Disclaimer: These regulations may not be the most recent version. West Virginia may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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