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 69-9-2 - DEFINITIONS

2.1. Abuse - means the threat to a patient's health or welfare by a person who knowingly or intentionally inflicts, attempts to inflict or knowingly allows another person to inflict physical injury or mental or emotional injury upon the patient; or sexual abuse or sexual exploitation.

2.2. Addiction - means a disease characterized by an individual pursuing reward and/or relief with substance use and/or other behaviors. Addiction is characterized by impairment in behavioral control, craving, inability to consistently abstain, and diminished recognition of significant problems with one's behaviors and interpersonal relationships; likely to involve cycles of relapse and remission.

2.3. Administrator - means an individual designated by the governing body of the neonatal abstinence center to be responsible for the day-to-day operation of the neonatal abstinence syndrome center.

2.4. Adult Protective Services/Child Protective Services (APS/GPS) Background Check - means an authorized disclosure of an individual's history with the Department as an identified adult or child abuse maltreator.

2.5. Annual Inspection - means a recurring inspection by the Department that will take place once every nine to 15 months.

2.6. Applicant - means the person or entity who submits an application for a license or renewal of a license to operate a neonatal abstinence syndrome center.

2.7. Bed Capacity - means the maximum number of beds a neonatal abstinence syndrome center is licensed to offer for residential care and occupancy.

2.8. Care Plan - means a document, based on a comprehensive assessment and prepared by the interdisciplinary team in conjunction with the patient's parent, family and/or legal representative that identifies measurable goals and objectives for the highest level of functioning the patient is expected to attain or maintain.

2.9. Change of Ownership - means any transaction that results in the change of control over the capital assets of a neonatal abstinence syndrome center including, but not limited to, a conditional sale, a sale, a lease or a transfer of title or controlling stock.

2.10. Complaint - means a verbal or written statement made by a patient, family member, legal representative and/or community member and filed with the program administrator or a state oversight agency alleging inadequate or inappropriate service on the part of a neonatal abstinence syndrome center.

2.11. Conflict of Interest - means any action that results in, or has the appearance of resulting in, personal, organizational, or professional gain.

2.12. Critical Incident or Adverse Event - means an incident resulting in or the potential for significant harm or death to a patient; an immediate threat to care or safety of an individual, either staff or patient; the possibility of serious operational or personnel problems within the center; or the potential to undermine public confidence in the neonatal abstinence syndrome center.

2.13. Deficiency - means a neonatal abstinence center's failure to meet a specific requirement under the provisions of this rule. A deficiency cited by the Department shall explicitly state which requirement was not met, and include evidence to support the Department's decision of noncompliance.

2.14. Department - means the West Virginia Department of Health and Human Resources.

2.15. Director - means the Director of the Office of Health Facility Licensure and Certification.

2.16. Diversion Control Plan - means a required plan developed by the neonatal abstinence syndrome center to minimize the diversion of methadone or other medications to illicit use.

2.17. Employee - means any person who performs personal services for the neonatal abstinence syndrome center in exchange for monetary compensation. Such personal services that include the results to be accomplished, as well as the details and the means by which the results are accomplished, are controlled and directed by the neonatal abstinence center. Monetary compensation is effected through the neonatal abstinence center's payroll system.

2.18. Experimental Research - means development and testing of clinical treatments, such as an investigational drug or therapy, involving treatment or control groups or both. For example, a clinical trial of an investigational drug is experimental research.

2.19. Facility - means the physical building in which a neonatal abstinence syndrome center services are provided.

2.20. Family - means a group of two or more persons related by blood, marriage, foster relationship, or adoption.

2.21. For-Cause Inspection - means an inspection by the state oversight agency that may be operating in violation of state neonatal abstinence syndrome center standards, may be providing substandard treatment or may be serving as a possible source of diverted medications.

2.22. Governing Body - means the person or persons identified as being legally responsible for the operation of the neonatal abstinence syndrome center. A governing body may be a board, a single entity or ownership or a partnership.

2.23. Grievance - means a written or oral complaint filed with the program administrator or the state operating agency alleging inadequate or inappropriate treatment by the neonatal abstinence syndrome center.

2.24. Harm - means noncompliance with this rule that has negatively affected the patient so that the patient's physical, mental or psychosocial well-being has been compromise, and is not temporary in nature.

2.25. Immediate Jeopardy - means a situation in which the neonatal abstinence syndrome center's noncompliance with one or more requirements of this rule has caused, or is likely to cause, serious injury, harm, impairment, or death of a patient.

2.26. Individualized Plan of Care - means a plan of treatment and care developed by the patient's interdisciplinary team that outlines the attainable short term and long term treatment goals, the services to be provided, the frequency of services, and the responsible party for each goal and service.

2.27. Informed Consent - means written acknowledgment and verification by the patient's legal representative stating that information on the advantages and disadvantages of all aspects of the treatment provided to the patient and that the patient's legal representative agrees to the treatment.

2.28. Interdisciplinary Team - means a group of professionals and paraprofessionals responsible to develop, approve, and coordinate the individualized treatment plan of care and services for the patient.

2.29. Legal Representative - means the parent or parents of a minor patient, or a person appointed as guardian pursuant to the West Virginia Guardianship and Conservatorship Act, W. Va. Code § 44A-1-1 et seq., within the limits set by the appointing order, or the legal custodian as identified by the person appointed as guardian.

2.30. License - means the document issued by the state oversight agency that constitutes the neonatal abstinence syndrome center's authority to receive patients and perform services within the scope of this rule.

2.31. Licensed or Registered - means the person licensed or registered to follow a profession by the proper authority within the state of West Virginia. When applied to a neonatal abstinence syndrome center, it means the facility is licensed by the state oversight agency.

2.32. Licensee - means a person, persons or entity holding a license to operate a neonatal abstinence syndrome center, and who is responsible for compliance with all rules and minimum standards.

2.33. Medical Director - means the physician licensed within the state of West Virginia who assumes responsibility for administering all medical services performed by the neonatal abstinence syndrome center, either by performing them directly or by delegating specific responsibility to authorized program physicians and health care professionals functioning under the medical director's supervision.

2.34. Medication Error - means any preventable event where a dose of medication received, or not received by a patient differs from what the prescriber has prescribed.

2.35. Misappropriation - means the deliberate misplacement, exploitation or wrongful use of a patient's belongings or money.

2.36. Neglect - means the failure to provide goods and services, including but not limited to, adequate nutrition, clothing, shelter, supervision, medical care or education, or abandonment.

2.37. Neonatal - means the period of time covering the first 28 days after birth.

2.38. Neonatal Abstinence Center - means any center or facility, however named, within the state of West Virginia, which is advertised, offered, maintained or operated by the ownership or management, whether for consideration or not, for the express or implied purpose of providing accommodations and care, for a period of more than 24 hours but not to exceed 30 days, unless the physician recommends a longer length of stay based on documented evidence-based practices and the infant's individual response to treatment.

2.39. Neonatal Abstinence Syndrome (NAS) - means a group of symptoms that occur in a newborn who was exposed to addictive drugs while in the mother's womb, and includes prenatal exposure to a neuroactive substance and exhibits clinical signs and symptoms of withdrawal, regardless of whether pharmacological treatment is required.

2.40. Noncompliance - means any deficient practice or non-conformity that causes a neonatal abstinence syndrome center to not be in substantial compliance with this rule.

2.41. Non-Pharmacological Intervention - means evidence-based treatment, excluding the use of pharmacological interventions, for neonatal abstinence syndrome that is recognized by the American Academy of Pediatrics, or a nationally recognized organization with expertise in neonatal abstinence syndrome.

2.42. Office of Health Facility Licensure and Certification - means the state oversight agency responsible to enforce this rule.

2.43. Orientation - means the introduction of the legal representative, parents, and/or family to the policies and procedures of the neonatal abstinence syndrome center.

2.44. Patient - means an individual under six months old receiving treatment from a neonatal abstinence syndrome center.

2.45. Pharmacological Treatment - means the use of prescribed medications indicated to relieve moderate to severe signs of NAS and to prevent complications such as fever, weight loss, and seizures that is recognized by the American Academy of Pediatrics, or a nationally recognized organization with expertise in neonatal abstinence syndrome.

2.46. Physician - means an individual licensed to practice allopathic medicine by the West Virginia Board of Medicine pursuant to W. Va. Code § 30-3-1 et. seq., or osteopathic medicine by the West Virginia Board of Osteopathy pursuant to W. Va. Code § 30-14-1 et seq.

2.47. Plan of Care - means the overall profile of services and expected outcomes of care that may include plans to meet the person's needs after discharge. This includes all care and services outlined in the medical record.

2.48. Plan of Correction - means a written description of the actions the neonatal abstinence syndrome center intends to take to correct and prevent the reoccurrence of violations of a rule or policy identified by the designated state oversight agency during an investigation or survey.

2.49. Program Sponsor - means the person named in the application for certification and licensure of a neonatal abstinence syndrome center who is responsible for the operation of the neonatal abstinence syndrome center, and who assumes responsibility for all of its employees, and contractors. The program sponsor is not required to be a licensed physician, but shall employ a licensed physician for the position of medical director.

2.50. Protective Services - means Child or Adult Protective Services operating under the West Virginia Department of Health and Human Resources.

2.51. Repeat Deficiency - means a deficiency that meets all of the following conditions: is cited on the current inspection; was cited on the previous inspection or any intervening inspection between the current inspection and the previous inspection; has had a plan of correction submitted for the previous inspection or any intervening inspection that was accepted by the Director; and is cited based on the same regulatory grouping.

2.52. Secretary - means the Secretary of the West Virginia Department of Health and Human Resources, or his or her designee.

2.53. Scoring System - means a formal, validated method for assessing NAS severity that is recognized by the American Academy of Pediatrics, or a nationally recognized organization with expertise in neonatal abstinence syndrome.

2.54. State Oversight Agency - means the Office of Health Facility Licensure and Certification.

2.55. Variance - means a formal agreement between state oversight agency and the neonatal abstinence center that allows the program to comply with the intent of the regulatory rule, policy or standard in a manner not otherwise permitted by this rule, policy or standard. A variance may not be obtained based solely on the inability to achieve compliance.

2.56. Volunteer - means individuals who perform services without pay.