DEPARTMENT OF HEALTH

(Pharmacy Quality Assurance Commission)

For the purposes of this chapter, the following words and phrases shall have the following meanings unless the content clearly indicates otherwise.

(1) "Authorized contractor" means any person or persons:

• Registered under chapter 18.27 RCW; and

• Certified by the department to decontaminate, demolish, or dispose of contaminated property as required by chapter 64.44 RCW and this chapter.

(2) "Basic course" means a training course which has been sponsored or approved by the department for workers and supervisors who perform or supervise decontamination on illegal drug manufacturing or storage sites.

(3) "Certificate" means a department issued written approval under this chapter.

(4) "Certified" means a person who has department issued written approval under this chapter.

(5) "Contaminated" or "contamination" means polluted by hazardous chemicals so that the property is unfit for human habitation or use due to immediate or long-term hazards. Property that at one time was contaminated, but has been satisfactorily decontaminated according to procedures established by the state board of health is not "contaminated."

(6) "Decontamination" means the process of reducing levels of known contaminants to the lowest practical level using currently available methods and processes.

(7) "Department" means the Washington state department of health.

(8) "Disposal of contaminated property" means the disposition of contaminated property under the provisions of chapter 70.105 RCW.

(9) "Hazardous chemicals" means the following substances used in the manufacture of illegal drugs:

• Hazardous substances as defined in RCW 70.105D.020; and

• Precursor substances as defined in RCW 69.43.010 which the state board of health, in consultation with the ((state board of)) pharmacy quality assurance commission, has determined present an immediate or long-term health hazard to humans.

(10) "Illegal drug manufacturing or storage site" means any property where a person illegally manufactures or stores a controlled substance or a law enforcement agency or the property owner believes a person illegally manufactured or stored a controlled substance.

(11) "Initial site assessment" means the first evaluation of a property to determine the nature and extent of observable damage and contamination.

(12) "List of contaminated properties" means a list of properties contaminated by illegal drug manufacturing or the storage of hazardous chemicals.

(13) "Local department" means the jurisdictional local health department or district.

(14) "Local health officer" means a health officer or authorized representative as defined under chapters 70.05, 70.08, and 70.46 RCW.

(15) "Person" means an individual, firm, association, copartnership, political subdivision, government agency, municipality, industry, public or private corporation, or other entity.

(16) "Posting" means attaching a written or printed announcement conspicuously on property which may be, or is determined to be, contaminated by illegal drug manufacturing or the storage of a hazardous chemical.

(17) "Property" means any site, lot, parcel of land, structure, or part of a structure involved in the illegal manufacture of a drug or storage of a hazardous chemical including, but not limited to:

• Single-family residences;

• Units or multiplexes;

• Condominiums;

• Apartment buildings;

• Motels and hotels;

• Boats;

• Motor vehicles;

• Trailers;

• Manufactured housing;

• Any ship, booth, or garden; or

• Any site, lot, parcel of land, structure, or part of a structure that may be contaminated by previous use.

(18) "Property owner" means a person with a lawful right of possession of the property by reason of obtaining it by purchase, exchange, gift, lease, inheritance, or legal action.

(19) "Refresher course" means a department sponsored or approved biennial training course for decontamination workers and supervisors. An approved refresher course:

• Reviews the subjects taught in the initial training course; and

• Includes updated information on emerging decontamination technology.

(20) "Storage site" means any property used for the storage of hazardous chemicals or illegally manufactured controlled substances.

(21) "Supervisor" means a person certified by the department and employed by an authorized contractor who is on site during the decontamination of an illegal drug manufacturing or storage site and who is responsible for the activities performed.

(23) "Worker" means a person certified by the department and employed by an authorized contractor who performs decontamination of an illegal drug manufacturing or storage site.

For the purposes of this chapter and chapter 70.41 RCW, the following words and phrases will have the following meanings unless the context clearly indicates otherwise:

(1) "Abuse" means injury or sexual abuse of a patient indicating the health, welfare, and safety of the patient is harmed:

(a) "Physical abuse" means acts or incidents which may result in bodily injury or death.

(b) "Emotional abuse" means verbal behavior, harassment, or other actions which may result in emotional or behavioral stress or injury.

(2) "Agent," when referring to a medical order or procedure, means any power, principle, or substance, whether physical, chemical, or biological, capable of producing an effect upon the human body.

(3) "Alcoholism" means a disease, characterized by a dependency on alcoholic beverages, loss of control over the amount and circumstances of use, symptoms of tolerance, physiological or psychological withdrawal, or both, if use is reduced or discontinued, and impairment of health or disruption of social or economic functioning.

(4) "Alteration" means any change, addition, or modification to an existing hospital or a portion of an existing hospital.

"Minor alteration" means renovation that does not require an increase in capacity to structural, mechanical or electrical systems, which does not affect fire and life safety, and which does not add beds or facilities in addition to that for which the hospital is currently licensed.

(5) "Assessment" means the:

(a) Systematic collection and review of patient-specific data;

(b) A process for obtaining appropriate and necessary information about individuals seeking entry into a health care setting or service; and

(c) Information used to match an individual with an appropriate setting or intervention. The assessment is based on the patient's diagnosis, care setting, desire for care, response to any previous treatment, consent to treatment, and education needs.

(6) "Authentication" means the process used to verify an entry is complete, accurate, and final.

(7) "Bed, bed space or bassinet" means the physical environment and equipment (both movable and stationary) designed and used for twenty-four hour or more care of a patient including level 2 and 3 bassinets. This does not include stretchers, exam tables, operating tables, well baby bassinets, labor bed, and labor-delivery-recovery beds.

(8) "Child" means an individual under the age of eighteen years.

(9) "Clinical evidence" means the same as original clinical evidence used in diagnosing a patient's condition or assessing a clinical course and includes, but is not limited to:

(a) X-ray films;

(b) Digital records;

(c) Laboratory slides;

(d) Tissue specimens; and

(e) Medical photographs.

(10) "Critical care unit or service" means the specialized medical and nursing care provided to patients facing an immediate life-threatening illness or injury. Care is provided by multidisciplinary teams of highly skilled physicians, nurses, pharmacists or other health professionals who interpret complex therapeutic and diagnostic information and have access to sophisticated equipment.

(11) "Department" means the Washington state department of health.

(12) "Dietitian" means an individual meeting the eligibility requirements for active membership in the American Dietetic Association described in Directory of Dietetic Programs Accredited and Approved, American Dietetic Association, edition 100, 1980.

(13) "Double-checking" means verifying patient identity, agent to be administered, route, quantity, rate, time, and interval of administration by two persons.

(14) "Drugs" as defined in RCW 18.64.011(3) means:

(a) Articles recognized in the official U.S. Pharmacopoeia or the official Homeopathic Pharmacopoeia of the United States;

(b) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;

(c) Substances (other than food) intended to affect the structure or any function of the body of man or other animals; or

(d) Substances intended for use as a component of any substances specified in (a), (b), or (c) of this subsection but not including devices or component parts or accessories.

(15) "Electrical receptacle outlet" means an outlet where one or more electrical receptacles are installed.

(16) "Emergency care to victims of sexual assault" means medical examinations, procedures, and services provided by a hospital emergency room to a victim of sexual assault following an alleged sexual assault.

(17) "Emergency contraception" means any health care treatment approved by the Food and Drug Administration that prevents pregnancy, including, but not limited to, administering two increased doses of certain oral contraceptive pills within seventy-two hours of sexual contact.

(18) "Emergency department" means the area of a hospital where unscheduled medical or surgical care is provided to patients who need care.

(19) "Emergency room" means a space where emergency services are delivered and set apart by floor-to-ceiling partitions on all sides with proper access to an exit access and with all openings provided with doors or windows.

(20) "Emergency medical condition" means a condition manifesting itself by acute symptoms of severity (including severe pain, symptoms of mental disorder, or symptoms of substance abuse) that absent immediate medical attention could result in:

(a) Placing the health of an individual in serious jeopardy;

(b) Serious impairment to bodily functions;

(c) Serious dysfunction of a bodily organ or part; or

(d) With respect to a pregnant woman who is having contractions:

(i) That there is inadequate time to effect a safe transfer to another hospital before delivery; or

(ii) That the transfer may pose a threat to the health or safety of the woman or the unborn child.

(21) "Emergency services" means health care services medically necessary to evaluate and treat a medical condition that manifests itself by the acute onset of a symptom or symptoms, including severe pain, that would lead a prudent layperson acting reasonably to believe that a health condition exists that requires immediate medical attention, and that the absence of immediate medical attention could reasonably be expected to result in serious impairment to bodily functions or serious dysfunction of an organ or part of the body, or would place the person's health, or in the case of a pregnant woman, the health of the woman or her unborn child, in serious jeopardy.

(22) "Emergency triage" means the immediate patient assessment by a registered nurse, physician, or physician assistant to determine the nature and urgency of the person's medical need for treatment.

(23) "Family" means individuals designated by a patient who need not be relatives.

(24) "General hospital" means a hospital that provides general acute care services, including emergency services.

(25) "Governing authority/body" means the person or persons responsible for establishing the purposes and policies of the hospital.

(26) "High-risk infant" means an infant, regardless of age, whose existence is compromised, prenatal, natal, or postnatal factors needing special medical or nursing care.

(27) "Hospital" means any institution, place, building, or agency providing accommodations, facilities, and services over a continuous period of twenty-four hours or more, for observation, diagnosis, or care of two or more individuals not related to the operator who are suffering from illness, injury, deformity, or abnormality, or from any other condition for which obstetrical, medical, or surgical services would be appropriate for care or diagnosis. "Hospital" as used in this chapter does not include:

(a) Hospice care centers which come within the scope of chapter 70.127 RCW;

(b) Hotels, or similar places, furnishing only food and lodging, or simply domiciliary care;

(c) Clinics or physicians' offices, where patients are not regularly kept as bed patients for twenty-four hours or more;

(d) Nursing homes, as defined in and which come within the scope of chapter 18.51 RCW;

(e) Birthing centers, which come within the scope of chapter 18.46 RCW;

(f) Psychiatric or alcoholism hospitals, which come within the scope of chapter 71.12 RCW; nor

(g) Any other hospital or institution specifically intended for use in the diagnosis and care of those suffering from mental illness, mental retardation, convulsive disorders, or other abnormal mental conditions.

Furthermore, nothing in this chapter will be construed as authorizing the supervision, regulation, or control of the remedial care or treatment of residents or patients in any hospital conducted for those who rely primarily upon treatment by prayer or spiritual means in accordance with the creed or tenets of any well-recognized church or religious denominations.

(28) "Individualized treatment plan" means a written and/or electronically recorded statement of care planned for a patient based upon assessment of the patient's developmental, biological, psychological, and social strengths and problems, and including:

(a) Treatment goals, with stipulated time frames;

(b) Specific services to be utilized;

(c) Designation of individuals responsible for specific service to be provided;

(d) Discharge criteria with estimated time frames; and

(e) Participation of the patient and the patient's designee as appropriate.

(29) "Infant" means an individual not more than twelve months old.

(30) "Invasive procedure" means a procedure involving puncture or incision of the skin or insertion of an instrument or foreign material into the body including, but not limited to, percutaneous aspirations, biopsies, cardiac and vascular catheterizations, endoscopies, angioplasties, and implantations. Excluded are venipuncture and intravenous therapy.

(31) "Licensed practical nurse" means an individual licensed under provisions of chapter 18.79 RCW.

(32) "Maintenance" means the work of keeping something in safe, workable or suitable condition.

(33) "Medical equipment" means equipment used in a patient care environment to support patient treatment and diagnosis.

(34) "Medical staff" means physicians and other practitioners appointed by the governing authority.

(35) "Medication" means any substance, other than food or devices, intended for use in diagnosing, curing, mitigating, treating, or preventing disease.

(36) "Multidisciplinary treatment team" means a group of individuals from various disciplines and clinical services who assess, plan, implement, and evaluate treatment for patients.

(37) "Neglect" means mistreatment or maltreatment; a disregard of consequences or magnitude constituting a clear and present danger to an individual patient's health, welfare, and safety.

(a) "Physical neglect" means physical or material deprivation, such as lack of medical care, lack of supervision, inadequate food, clothing, or cleanliness.

(b) "Emotional neglect" means acts such as rejection, lack of stimulation, or other acts which may result in emotional or behavioral problems, physical manifestations, and disorders.

(38) "Neonate" means a newly born infant under twenty-eight days of age.

(39) "Neonatologist" means a pediatrician who is board certified in neonatal-perinatal medicine or board eligible in neonatal-perinatal medicine, provided the period of eligibility does not exceed three years, as defined and described in Directory of Residency Training Programs by the Accreditation Council for Graduate Medical Education, American Medical Association, 1998 or the American Osteopathic Association Yearbook and Directory, 1998.

(40) "New construction" means any of the following:

(a) New facilities to be licensed as a hospital;

(b) Renovation; or

(c) Alteration.

(41) "Nonambulatory" means an individual physically or mentally unable to walk or traverse a normal path to safety without the physical assistance of another.

(42) "Nursing personnel" means registered nurses, licensed practical nurses, and unlicensed assistive nursing personnel providing direct patient care.

(43) "Operating room (OR)" means a room intended for invasive and noninvasive surgical procedures.

(44) "Patient" means an individual receiving (or having received) preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative health services.

(a) "Inpatient" means services that require admission to a hospital for twenty-four hours or more.

(b) "Outpatient" means services that do not require admission to a hospital for twenty-four hours or more.

(45) "Patient care areas" means all areas of the hospital where direct patient care is delivered and where patient diagnostic or treatment procedures are performed.

(46) "Patient care unit or area" means a physical space of the hospital including rooms or areas containing beds or bed spaces, with available support ancillary, administrative, and services for patient.

(47) "Person" means any individual, firm, partnership, corporation, company, association, or joint stock association, and the legal successor thereof.

(48) "Pharmacist" means an individual licensed by the ((state board of)) pharmacy quality assurance commission under chapter 18.64 RCW.

(49) "Pharmacy" means every place properly licensed by the ((board of)) pharmacy quality assurance commission where the practice of pharmacy is conducted.

(50) "Physician" means an individual licensed under chapter 18.71 RCW, Physicians, chapter 18.22 RCW, Podiatric medicine and surgery, or chapter 18.57 RCW, Osteopathy—Osteopathic medicine and surgery.

(51) "Prescription" means an order for drugs or devices issued by a practitioner authorized by law or rule in the state of Washington for a legitimate medical purpose.

(52) "Procedure" means a particular course of action to relieve pain, diagnose, cure, improve, or treat a patient's condition.

(53) "Protocols" and "standing order" mean written or electronically recorded descriptions of actions and interventions for implementation by designated hospital staff under defined circumstances under hospital policy and procedure.

(54) "Psychiatric service" means the treatment of patients pertinent to a psychiatric diagnosis.

(55) "Recovery unit" means a physical area for the segregation, concentration, and close or continuous nursing observation of patients for less than twenty-four hours immediately following anesthesia, obstetrical delivery, surgery, or other diagnostic or treatment procedures.

(56) "Registered nurse" means an individual licensed under chapter 18.79 RCW.

(57) "Restraint" means any method used to prevent or limit free body movement including, but not limited to, involuntary confinement, a physical or mechanical device, or a drug given not required to treat a patient's symptoms.

(58) "Room" means a space set apart by floor-to-ceiling partitions on all sides with proper access to a corridor and with all openings provided with doors or windows.

(59) "Seclusion" means the involuntary confinement of a patient in a room or area where the patient is physically prevented from leaving.

(60) "Seclusion room" means a secure room designed and organized for temporary placement, care, and observation of one patient with minimal sensory stimuli, maximum security and protection, and visual and auditory observation by authorized personnel and staff. Doors of seclusion rooms have staff-controlled locks.

(61) "Sexual assault" means one or more of the following:

(a) Rape or rape of a child;

(b) Assault with intent to commit rape or rape of a child;

(c) Incest or indecent liberties;

(d) Child molestation;

(e) Sexual misconduct with a minor;

(f) Custodial sexual misconduct;

(g) Crimes with a sexual motivation; or

(h) An attempt to commit any of the items in (a) through (g) of this subsection.

(62) "Severe pain" means a level of pain reported by a patient of 8 or higher based on a 10 point scale with 1 being the least and 10 being the most pain.

(63) "Specialty hospital" means a subclass of hospital that is primarily or exclusively engaged in the care and treatment of one of the following categories:

(a) Patients with a cardiac condition;

(b) Patients with an orthopedic condition;

(c) Patients receiving a surgical procedure; and

(d) Any other specialized category of services that the secretary of health and human services designates as a specialty hospital.

(64) "Staff" means paid employees, leased or contracted persons, students, and volunteers.

(65) "Surgical procedure" means any manual or operative procedure performed upon the body of a living human being for the purpose of preserving health, diagnosing or curing disease, repairing injury, correcting deformity or defect, prolonging life or relieving suffering, and involving any of the following:

(a) Incision, excision, or curettage of tissue;

(b) Suture or repair of tissue including a closed as well as an open reduction of a fracture;

(c) Extraction of tissue including the premature extraction of the products of conception from the uterus; or

(d) An endoscopic examination.

(66) "Surrogate decision-maker" means an individual appointed to act on behalf of another when an individual is without capacity as defined in RCW 7.70.065 or has given permission.

(67) "Transfer agreement" means a written agreement providing an effective process for the transfer of a patient requiring emergency services to a general hospital providing emergency services and for continuity of care for that patient.

(68) "Treatment" means the care and management of a patient to combat, improve, or prevent a disease, disorder, or injury, and may be:

(a) Pharmacologic, surgical, or supportive;

(b) Specific for a disorder; or

(c) Symptomatic to relieve symptoms without effecting a cure.

(69) "Unlicensed assistive personnel (UAP)" means individuals trained to function in an assistive role to nurses in the provision of patient care, as delegated by and under the supervision of the registered nurse. Typical activities performed by unlicensed assistive personnel include, but are not limited to: Taking vital signs; bathing, feeding, or dressing patients; assisting patient with transfer, ambulation, or toileting. Definition includes: Nursing assistants; orderlies; patient care technicians/assistants; and graduate nurses (not yet licensed) who have completed unit orientation. Definition excludes: Unit secretaries or clerks; monitor technicians; therapy assistants; student nurses fulfilling educational requirements; and sitters who are not providing typical UAP activities.

(70) "Victim of sexual assault" means a person is alleged to have been sexually assaulted and who presents as a patient.

(71) "Vulnerable adult" means, as defined in chapter 74.34 RCW, a person sixty years of age or older who lacks the functional, physical, or mental ability to care for him or herself; an adult with a developmental disability under RCW 71A.10.020; an adult with a legal guardian under chapter 11.88 RCW; an adult living in a long-term care facility (an adult family home, assisted living facility or nursing home); an adult living in their own or a family's home receiving services from an agency or contracted individual provider; or an adult self-directing their care under RCW 74.39.050. For the purposes of requesting background checks pursuant to RCW 43.43.832, it shall also include adults of any age who lack the functional, mental, or physical ability to care for themselves. For the purposes of this chapter, it shall also include hospitalized adults.

(72) "Well-being" means free from actual or potential harm, abuse, neglect, unintended injury, death, serious disability or illness.

This section outlines the department's on-site survey and complaint investigation activities and roles.

(1) Surveys. The department will:

(a) Conduct on-site surveys of each hospital on average at least every eighteen months or more often using the health and safety standards in this chapter and chapter 70.41 RCW;

(b) Coordinate the on-site survey with other agencies, including local fire jurisdictions, state fire marshal, ((state)) and the pharmacy ((board)) quality assurance commission, and report the survey findings to those agencies;

(c) Notify the hospital in writing of the survey findings following each on-site survey;

(d) Require each hospital to submit a corrective action plan addressing each deficient practice identified in the survey findings;

(e) Notify the hospital when the hospital submitted plan of correction adequately addresses the survey findings; and

(f) Accept on-site surveys conducted by the Joint Commission or American Osteopathic Association as meeting the eighteen-month survey requirement in accordance with RCW 70.41.122.

(2) Complaint investigations. The department will:

(a) Conduct an investigation of every complaint against a hospital that concerns patient well being;

(b) Notify the hospital in writing of state complaint investigation findings following each complaint investigation;

(c) Require each hospital to submit a corrective action plan addressing each deficient practice identified in the complaint investigation findings; and

(d) Notify the hospital when the hospital submitted plan of correction adequately addresses the complaint investigation findings.

(3) The department may:

(a) Direct a hospital on how to implement a corrective action plan based on the findings from an on-site survey or complaint investigation; or

(b) Contact a hospital to discuss the findings of the Joint Commission or American Osteopathic Association on-site accreditation survey.

The licensee shall:

(1) Maintain the pharmacy in the hospital in a safe, clean, and sanitary condition;

(2) Provide evidence of current approval of pharmacy services by the ((Washington state board of)) pharmacy quality assurance commission under chapter 18.64 RCW;

(3) Develop and implement procedures for prescribing, storing, and administering medications according to state and federal laws and rules, including:

(a) Assuring professional staff who prescribe are authorized to prescribe under chapter 69.41 RCW;

(b) Assuring orders and prescriptions for medications administered and self-administered include:

(i) Date and time;

(ii) Type and amount of drug;

(iii) Route of administration;

(iv) Frequency of administration; and

(v) Authentication by professional staff;

(c) Administering drugs;

(d) Self-administering drugs;

(e) Receiving and recording or transcribing verbal or telephone drug orders by authorized staff;

(f) Authenticating verbal and telephone orders by prescriber in a timely manner, not to exceed forty-eight hours for inpatients;

(g) Use of medications and drugs owned by the patient but not dispensed by the hospital pharmacy, including:

(i) Specific written orders;

(ii) Identification and administration of drug;

(iii) Handling, storage and control;

(iv) Disposition; and

(v) Pharmacist and physician inspection and approval prior to patient use to ensure proper identification, lack of deterioration, and consistency with current medication profile;

(h) Maintaining drugs in patient care areas of the hospital including:

(i) Hospital pharmacist or consulting pharmacist responsibility;

(ii) Legible labeling with generic and/or trade name and strength as required by federal and state laws;

(iii) Access only by staff authorized access under hospital policy;

(iv) Storage under appropriate conditions specified by the hospital pharmacist or consulting pharmacist, including provisions for:

(A) Storing medicines, poisons, and other drugs in a specifically designated, well-illuminated, secure space;

(B) Separating internal and external stock drugs; and

(C) Storing Schedule II drugs in a separate locked drawer, compartment, cabinet, or safe;

(i) Preparing drugs in designated rooms with ample light, ventilation, sink or lavatory, and sufficient work area;

(j) Prohibiting the administration of outdated or deteriorated drugs, as indicated by label;

(k) Restricting access to pharmacy stock of drugs to:

(i) Legally authorized pharmacy staff; and

(ii) Except for Schedule II drugs, to a registered nurse designated by the hospital when all of the following conditions are met:

(A) The pharmacist is absent from the hospital;

(B) Drugs are needed in an emergency, and are not available in floor supplies; and

(C) The registered nurse, not the pharmacist, is accountable for the registered nurse's actions;

(4) The appropriate professional staff committee shall approve all policies and procedures on drugs, after documented consultation with:

(a) The pharmacist or pharmacist consultant directing hospital pharmacy services; and

(b) An advisory group comprised of representatives from the professional staff, hospital administration, and nursing services;

(5) When planning new construction of a pharmacy:

(a) Follow the general design requirements for architectural components, electrical service, lighting, call systems, hardware, interior finishes, heating, plumbing, sewerage, ventilation/air conditioning, and signage in WAC 246-318-540;

(b) Provide housekeeping facilities within or easily accessible to the pharmacy;

(c) Locate pharmacy in a clean, separate, secure room with:

(i) Storage, including locked storage for Schedule II controlled substances;

(ii) All entrances equipped with closers;

(iii) Automatic locking mechanisms on all entrance doors to preclude entrance without a key or combination;

(iv) Perimeter walls of the pharmacy and vault, if used, constructed full height from floor to ceiling;

(v) Security devices or alarm systems for perimeter windows and relites;

(vi) An emergency signal device to signal at a location where twenty-four-hour assistance is available;

(vii) Space for files and clerical functions;

(viii) Break-out area separate from clean areas; and

(ix) Electrical service including emergency power to critical pharmacy areas and equipment;

(d) Provide a general compounding and dispensing unit, room, or area with:

(i) A work counter with impermeable surface;

(ii) A corrosion-resistant sink, suitable for handwashing, mounted in counter or integral with counter;

(iii) Storage space;

(iv) A refrigeration and freezing unit; and

(v) Space for mobile equipment;

(e) If planning a manufacturing and unit dose packaging area or room, provide with:

(i) Work counter with impermeable surface;

(ii) Corrosion-resistant sink, suitable for handwashing, mounted in counter or integral with counter; and

(iii) Storage space;

(f) Locate admixture, radiopharmaceuticals, and other sterile compounding room, if planned, in a low traffic, clean area with:

(i) A preparation area;

(ii) A work counter with impermeable surface;

(iii) A corrosion-resistant sink, suitable for handwashing, mounted in counter or integral with counter;

(iv) Space for mobile equipment;

(v) Storage space;

(vi) A laminar flow hood in admixture area; and

(vii) Shielding and appropriate ventilation according to WAC 246-318-540 (3)(m) for storage and preparation of radiopharmaceuticals;

(g) If a satellite pharmacy is planned, comply with the provisions of:

(i) Subsection (5)(a), (5)(c)(i), (ii), (iii), (iv), (v), and (vi) of this section when drugs will be stored;

(ii) Subsection (5)(c)(vii), (viii), and (ix) of this section, if appropriate; and

(iii) Subsections (5)(d) and (f) of this section if planned;

(h) If a separate outpatient pharmacy is planned, comply with the requirements for a satellite pharmacy including:

(i) Easy access;

(ii) A conveniently located toilet meeting accessibility requirements in WAC 51-20-3100; and

(iii) A private counseling area.

The definitions in this section apply throughout this chapter unless the context clearly requires otherwise:

(1) "Abuse" means injury or sexual abuse of a patient indicating the health, welfare, and safety of the patient is harmed:

(a) "Physical abuse" means acts or incidents which may result in bodily injury or death.

(b) "Emotional abuse" means to impose willful or reckless mental or emotional anguish by threat, verbal behavior, harassment, or other verbal or nonverbal actions which may result in emotional or behavioral stress or injury.

(2) "Advanced registered nurse practitioner" means an individual licensed under chapter 18.79 RCW.

(3) "Agent," when referring to a medical order or procedure, means any power, principle, or substance, whether physical, chemical, or biological, capable of producing an effect upon the human body.

(4) "Alteration" means any change, addition, functional change, or modification to an existing ambulatory surgical facility or a portion of an existing ambulatory surgical facility.

"Minor alteration" means renovation that does not require an increase in capacity to structural, mechanical or electrical systems, does not affect fire and life safety, and does not add facilities in addition to that for which the ambulatory surgical facility is currently licensed. Minor alterations do not require prior review and approval by the department.

(5) "Ambulatory surgical facility" means any distinct entity that operates for the primary purpose of providing specialty or multispecialty outpatient surgical services in which patients are admitted to and discharged from the facility within twenty-four hours and do not require inpatient hospitalization, whether or not the facility is certified under Title XVIII of the federal Social Security Act. An ambulatory surgical facility includes one or more surgical suites that are adjacent to and within the same building as, but not in, the office of a practitioner in an individual or group practice, if the primary purpose of the one or more surgical suites is to provide specialty or multispecialty outpatient surgical services, irrespective of the types of anesthesia administered in the one or more surgical suites. An ambulatory surgical facility that is adjacent to and within the same building as the office of a practitioner in an individual or group practice may include a surgical suite that shares a reception area, restroom, waiting room, or wall with the office of the practitioner in an individual or group practice.

(6) "Assessment" means the:

(a) Systematic collection and review of patient-specific data;

(b) A process for obtaining appropriate and necessary information about individuals seeking entry into the ambulatory surgical facility or service; and

(c) Information used to match an individual with an appropriate setting or intervention. The assessment is based on the patient's diagnosis, care setting, desire for care, response to any previous treatment, consent to treatment, and education needs.

(7) "Authentication" means the process used to verify an entry is complete, accurate, and final.

(8) "Change of ownership" means:

(a) A sole proprietor who transfers all or part of the ambulatory surgical facility's ownership to another person or persons;

(b) The addition, removal, or substitution of a person as a general, managing, or controlling partner in an ambulatory surgical facility owned by a partnership where the tax identification number of that ownership changes; or

(c) A corporation that transfers all or part of the corporate stock which represents the ambulatory surgical facility's ownership to another person where the tax identification number of that ownership changes.

(9) "Clinical evidence" means evidence used in diagnosing a patient's condition or assessing a clinical course and includes, but is not limited to:

(a) X-ray films;

(b) Digital records;

(c) Laboratory slides;

(d) Tissue specimens; or

(e) Medical photographs.

(10) "Department" means the Washington state department of health.

(11) "Double-checking" means verifying patient identity, agent to be administered, route, quantity, rate, time, and interval of administration by two persons.

(12) "Drugs" as defined in RCW 18.64.011(3) means:

(a) Articles recognized in the official United States pharmacopoeia or the official homeopathic pharmacopoeia of the United States;

(b) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;

(c) Substances (other than food) intended to affect the structure or any function of the body of man or other animals; or

(d) Substances intended for use as a component of any substances specified in (a), (b), or (c) of this subsection but not including devices or component parts or accessories.

(13) "Emergency medical condition" means a condition manifesting itself by acute symptoms of severity (including severe pain, symptoms of mental disorder, or symptoms of substance abuse) that absent of immediate medical attention could result in:

(a) Placing the health of an individual in serious jeopardy;

(b) Serious impairment to bodily functions;

(c) Serious dysfunction of a bodily organ or part; or

(d) With respect to a pregnant woman who is having contractions:

(i) That there is inadequate time to provide a safe transfer to a hospital before delivery; or

(ii) That the transfer may pose a threat to the health or safety of the woman or the unborn child.

(14) "Emergency services" means health care services medically necessary to evaluate and treat a medical condition that manifests itself by the acute onset of a symptom or symptoms, including severe pain, that would lead a prudent layperson acting reasonably to believe that a health condition exists that requires immediate medical attention, and that the absence of immediate medical attention could reasonably be expected to result in serious impairment to bodily functions or serious dysfunction of an organ or part of the body, or would place the person's health, or in the case of a pregnant woman, the health of the woman or her unborn child, in serious jeopardy.

(15) "Family" means individuals designated by a patient who need not be relatives.

(16) "General anesthesia" means a state of unconsciousness intentionally produced by anesthetic agents, with absence of pain sensation over the entire body, in which the patient is without protective reflexes and is unable to maintain an airway. Lower levels of sedation that unintentionally progress to the point at which the patient is without protective reflexes and is unable to maintain an airway is not considered general anesthesia.

(17) "Governing authority/body" means the person or persons responsible for establishing the purposes and policies of the ambulatory surgical facility.

(18) "Hospital" means any institution, place, building, or agency providing accommodations, facilities, and services as defined in chapter 70.41 RCW.

(19) "Individualized treatment plan" means a written and/or electronically recorded statement of care planned for a patient based upon assessment of the patient's developmental, biological, psychological, and social strengths and problems, and including:

(a) Treatment goals, with stipulated time frames;

(b) Specific services to be utilized;

(c) Designation of individuals responsible for specific service to be provided;

(d) Discharge criteria with estimated time frames; and

(e) Participation of the patient and the patient's designee as appropriate.

(20) "Invasive medical procedure" means a procedure involving puncture or incision of the skin or insertion of an instrument or foreign material into the body including, but not limited to, percutaneous aspirations, biopsies, cardiac and vascular catheterizations, endoscopies, angioplasties, and implantations. Excluded are venipuncture and intravenous therapy.

(21) "Maintenance" means the work of keeping something in safe, workable or suitable condition.

(22) "Medical equipment" means equipment used in a patient care environment to support patient treatment and diagnosis.

(23) "Medical staff" means practitioners and advanced registered nurse practitioners appointed by the governing authority.

(24) "Medication" means any substance, other than food or devices, intended for use in diagnosing, curing, mitigating, treating, or preventing disease.

(25) "Near miss" means an event which had the potential to cause serious injury, death, or harm but did not happen due to chance, corrective action or timely intervention.

(26) "Neglect" means mistreatment or maltreatment, a disregard of consequences constituting a clear and present danger to an individual patient's health, welfare, and safety.

(a) "Physical neglect" means physical or material deprivation, such as lack of medical care, lack of supervision, inadequate food, clothing, or cleanliness.

(b) "Emotional neglect" means acts such as rejection, lack of stimulation, or other acts that may result in emotional or behavioral problems, physical manifestations, and disorders.

(27) "New construction" means any renovation, alteration or new facility to be licensed as an ambulatory surgical facility.

(28) "Nonambulatory" means an individual physically or mentally unable to walk or traverse a normal path to safety without the physical assistance of another.

(29) "Operating room" means a room intended for invasive procedures.

(30) "Patient" means an individual receiving (or having received) preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative health services.

(31) "Patient care areas" means all areas of the ambulatory surgical facility where direct patient care is delivered and where patient diagnostic or treatment procedures are performed.

(32) "Person" means any individual, firm, partnership, corporation, company, association, joint stock association, and the legal successor thereof.

(33) "Pharmacist" means an individual licensed by the ((state board of)) pharmacy quality assurance commission under chapter 18.64 RCW.

(34) "Pharmacy" means every place properly licensed by the ((board of)) pharmacy quality assurance commission where the practice of pharmacy is conducted.

(35) "Physician" means an individual licensed under chapter 18.71 RCW, Physicians, chapter 18.22 RCW, Podiatric medicine and surgery, or chapter 18.57 RCW, Osteopathy—Osteopathic medicine and surgery.

(36) "Practitioner" means any physician or surgeon licensed under chapter 18.71 RCW, an osteopathic physician or surgeon licensed under chapter 18.57 RCW, or a podiatric physician or surgeon licensed under chapter 18.22 RCW.

(37) "Prescription" means an order for drugs or devices issued by a practitioner authorized by law or rule in the state of Washington for a legitimate medical purpose.

(38) "Protocols" and "standing order" mean written or electronically recorded descriptions of actions and interventions for implementation by designated ambulatory surgical facility staff under defined circumstances recorded in policy and procedure.

(39) "Recovery unit" means a physical area for the segregation, concentration, and close or continuous nursing observation of patients for less than twenty-four hours immediately following anesthesia, surgery, or other diagnostic or treatment procedures.

(40) "Registered nurse" means an individual licensed under chapter 18.79 RCW.

(41) "Restraint" means any method used to prevent or limit free body movement including, but not limited to, involuntary confinement, a physical or mechanical device, or a drug given not required to treat a patient's symptoms.

(42) "Room" means a space set apart by floor-to-ceiling partitions on all sides with proper access to a corridor and with all openings provided with doors or windows.

(43) "Sedation" means the administration of drugs to obtund, dull, reduce the intensity of pain or awareness, allay patient anxiety and control pain during a diagnostic or therapeutic procedure where the administration of those drugs by any route carries the risk of loss of protective reflexes to include any of the following:

(a) "Minimal sedation or anxiolysis" is a state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected;

(b) "Moderate or conscious sedation" is a depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained; and

(c) "Deep sedation" is a depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.

(44) "Sexual assault" means, according to RCW 70.125.030, one or more of the following:

(a) Rape or rape of a child;

(b) Assault with intent to commit rape or rape of a child;

(c) Incest or indecent liberties;

(d) Child molestation;

(e) Sexual misconduct with a minor;

(f) Custodial sexual misconduct;

(g) Crimes with a sexual motivation; or

(h) An attempt to commit any of the offenses in (a) through (h) of this subsection.

(45) "Severe pain" means a level of pain reported by a patient of 8 or higher based on a 10-point scale with 1 being the least and 10 being the most pain.

(46) "Staff" means paid employees, leased or contracted persons, students, and volunteers.

(47) "Surgical services" means invasive medical procedures that:

(a) Utilize a knife, laser, cautery, cytogenics, or chemicals; and

(b) Remove, correct, or facilitate the diagnosis or cure of disease, process or injury through that branch of medicine that treats diseases, injuries and deformities by manual or operative methods by a practitioner.

(48) "Surrogate decision-maker" means an individual appointed to act on behalf of another when an individual is without capacity or has given permission.

(49) "Transfer agreement" means a written agreement providing an effective process for the transfer of a patient requiring emergency services to a hospital providing emergency services and for continuity of care for that patient.

(50) "Treatment" means the care and management of a patient to combat, improve, or prevent a disease, disorder, or injury, and may be:

(a) Pharmacologic, surgical, or supportive;

(b) Specific for a disorder; or

(c) Symptomatic to relieve symptoms without effecting a cure.

(51) "Vulnerable adult" means:

(a) As defined in chapter 74.34 RCW, a person sixty years of age or older who lacks the functional, physical, or mental ability to care for him or herself;

(b) An adult with a developmental disability per RCW 71A.10.020;

(c) An adult with a legal guardian per chapter 11.88 RCW;

(d) An adult living in a long-term care facility (an adult family home, boarding home or nursing home);

(e) An adult living in their own or a family's home receiving services from an agency or contracted individual provider; or

(f) An adult self-directing their care per RCW 74.39.050;

(g) For the purposes of requesting background checks pursuant to RCW 43.43.832, it shall also include adults of any age who lack the functional, mental, or physical ability to care for themselves.

(52) "Well-being" means free from actual or potential harm, abuse, neglect, unintended injury, death, serious disability or illness.

For the purposes of this chapter, the following words and phrases will have the following meanings unless the context clearly indicates otherwise:

(1) "AAA" means the area agency on aging designated by the aging and adult services administration to contract for home care services with the department of social and health services.

(2) "Acute care" means care provided by an in-home services agency licensed to provide home health services for patients who are not medically stable or have not attained a satisfactory level of rehabilitation. These patients require frequent monitoring by a licensed nurse, therapist, dietician, or social worker to assess health status and progress.

(3) "Administrator" means an individual responsible for managing the operation of an in-home services agency.

(4) "Agency" means an in-home services agency licensed to provide home health, home care, hospice or hospice care center services.

(5) "Assessment" means:

(a) For home health and hospice agencies and hospice care centers, an evaluation of patient needs by an appropriate health care professional; or

(b) For home care agencies, an on-site visit by appropriate agency personnel to determine services requested or recommended to meet client needs.

(6) "Authenticated" means a written signature or unique identifier verifying accuracy of information.

(7) "Authorizing practitioner" means an individual authorized to approve a home health, hospice or hospice care center plan of care.

(a) For home health services:

(i) A physician licensed under chapter 18.57 or 18.71 RCW;

(ii) A podiatric physician and surgeon licensed under chapter 18.22 RCW; or

(iii) An advanced registered nurse practitioner (ARNP), as authorized under chapter 18.79 RCW;

(b) For hospice and hospice care center services:

(i) A physician licensed under chapter 18.57 or 18.71 RCW; or

(ii) An advanced registered nurse practitioner (ARNP), as authorized under chapter 18.79 RCW;

(8) "Bereavement" means care provided to the patient's family with the goal of alleviating the emotional and spiritual discomfort associated with the patient's death.

(9) "Client" means an individual receiving home care services.

(10) "Construction" for the purposes of hospice care centers means:

(a) New building(s) to be used as a hospice care center;

(b) Addition(s) to or conversion(s), either in whole or in part, of an existing building or buildings to be used as a hospice care center or a portion thereof; or

(c) Alteration or modification to a hospice care center.

(11) "Contractor" means an individual, person, or licensee who has a written contract with a licensee to provide patient or client care services or equipment.

(12) "Deemed status" means a designation assigned by the department for an in-home services agency licensed to provide home health, home care, or hospice services meeting the provisions of WAC 246-335-050, certified or accredited by organizations recognized by RCW 70.127.085, or monitored under contract with the department of social and health services under RCW 70.127.085 to provide home care services.

(13) "Department" means the Washington state department of health.

(14) "Dietician" means a person certified under chapter 18.138 RCW or registered by the American Dietetic Association.

(15) "Director of clinical services" means an individual responsible for nursing, therapy, nutritional, social, or related services that support the plan of care provided by in-home services agencies licensed to provide home health, hospice or hospice care center services.

(16) "Document" means the process of recording information relating to patient or client care verified by signature or unique identifier, title, and date.

(17) "Family" means an individual or individuals who are important to, and designated in writing by, the patient or client and need not be relatives, or who are legally authorized to represent the patient or client.

(18) "Health care professional" means an individual who provides health or health-related services within the individual's authorized scope of practice and who is licensed, registered or certified under Title 18 RCW, Business and professions.

(19) "Home care agency" or "in-home services agency licensed to provide home care services" means a person administering or providing home care services directly or through a contract arrangement to clients in places of permanent or temporary residence. A home care agency that provides delegated tasks of nursing under RCW 18.79.260 (3)(e) and rules adopted thereunder is not considered a home health agency for purposes of this chapter.

(20) "Home care aide" means an individual providing home care services.

(21) "Home care services" means nonmedical services and assistance provided to ill, disabled, or vulnerable clients that enables them to remain in their residences. Home care services include, but are not limited to: Personal care such as assistance with dressing, feeding and personal hygiene to facilitate self-care; homemaker assistance with household tasks, such as housekeeping, shopping, meal planning and preparation, and transportation; respite care assistance and support provided to the family; or other nonmedical tasks, as defined in this section or delegated tasks of nursing under RCW 18.79.260 (3)(e) and rules adopted thereunder.

(22) "Home health agency" or "in-home services agency licensed to provide home health services" means a person administering or providing two or more home health services directly or through a contract arrangement to patients in places of permanent or temporary residence. A person administering or providing only nursing services may elect to be an in-home services agency licensed to provide home health services.

(23) "Home health aide" means an individual registered or certified as a nursing assistant under chapter 18.88A RCW.

(24) "Home health aide services" means services provided by home health aides in an in-home services agency licensed to provide home health, hospice, or hospice care center services under the supervision of a registered nurse, physical therapist, occupational therapist, or speech therapist. Such care may include ambulation and exercise, medication assistance level 1 and level 2, reporting changes in patients' conditions and needs, completing appropriate records, and personal care or homemaker services, and other nonmedical tasks, as defined in this section.

(25) "Home health services" means services provided to ill, disabled, or vulnerable patients. These services include, but are not limited to, nursing services, home health aide services, physical therapy services, occupational therapy services, speech therapy services, respiratory therapy services, nutritional services, medical social services, home medical supplies or equipment services, and professional medical equipment assessment services.

(26) "Home medical supplies or equipment services" means providing diagnostic, treatment, and monitoring equipment and supplies used in the direct care of patients or clients as stated in a plan of care.

(27) "Homelike" for the purposes of a hospice care center means an environment having the qualities of a home, including privacy, comfortable surroundings, opportunities for patient self-expression, and supporting interaction with the family, friends, and community.

(28) "Hospice agency" or "in-home services agency licensed to provide hospice services" means a person administering or providing hospice services directly or through a contract arrangement to patients in places of permanent or temporary residence under the direction of an interdisciplinary team.

(29) "Hospice care center" or "in-home services agency licensed to provide hospice care center services" means a homelike, noninstitutional facility where hospice services are provided, and that meet the requirements for operation under RCW 70.127.280 and applicable rules.

(30) "Hospice care center service category" means the different levels of care provided in a hospice care center, including continuous care, general inpatient care, inpatient respite care, and routine home care.

(a) "Continuous care" means care for patients requiring a minimum of eight hours of one-to-one services in a calendar day, with assessment and supervision by an RN. An RN, LPN or home health aide may provide the care or treatment, according to practice acts and the rules adopted thereunder, of acute or chronic symptoms, including a crisis in their caregiving.

(b) "General inpatient care" means care for patients requiring an RN on-site twenty-four hours a day, for assessment and supervision. An RN, LPN or home health aide may provide the care or treatment, according to practice acts and the rules adopted thereunder, of acute or chronic symptoms, including a crisis in their caregiving.

(c) "Inpatient respite care" means care for patients whose caregivers require short-term relief of their caregiving duties.

(d) "Routine home care" means the core level of service for patients not receiving continuous care, general inpatient care, or inpatient respite care.

(31) "Hospice care center services" means hospice services provided in a hospice care center and may include any of the levels of care defined as hospice care center service categories.

(32) "Hospice services" means symptom and pain management provided to a terminally ill patient, and emotional, spiritual and bereavement support for the patient and family in a place of temporary or permanent residence, including hospice care centers, and may include the provision of home health and home care services for the terminally ill patient through an in-home services agency licensed to provide hospice or hospice care center services.

(33) "In-home services agency" or "in-home services licensee" means a person licensed to administer or provide home health, home care, hospice or hospice care center services directly or through a contract arrangement to patients or clients in a place of temporary or permanent residence.

(34) "In-home services category" means home health, home care, hospice, or hospice care center services.

(35) "Interdisciplinary team" means the group of individuals involved in patient care providing hospice services or hospice care center services including, at a minimum, a physician, registered nurse, social worker, spiritual counselor and volunteer.

(36) "Licensed practical nurse" or "LPN" means an individual licensed as a practical nurse under chapter 18.79 RCW.

(37) "Licensed nurse" means a licensed practical nurse or registered nurse.

(38) "Licensee" means the person to whom the department issues the in-home services license.

(39) "Maintenance care" means care provided by in-home services agencies licensed to provide home health services that are necessary to support an existing level of health, to preserve a patient from further failure or decline, or to manage expected deterioration of disease. These patients require periodic monitoring by a licensed nurse, therapist, dietician, or social worker to assess health status and progress.

(40) "Managed care plan" means a plan controlled by the terms of the reimbursement source.

(41) "Medical director" means a physician licensed under chapter 18.57 or 18.71 RCW responsible for the medical component of patient care provided in an in-home services agency licensed to provide hospice and hospice care center services according to WAC 246-335-055 (4)(a).

(42) "Medication assistance level 1" means home health aide assistance with medications, that includes the application, instillation or insertion of medications under a plan of care, for patients of an in-home services agency licensed to provide home health, hospice or hospice care center services and are under the direction of appropriate agency health care personnel. The assistance must be provided in accordance with the Nurse Practice Act as defined in chapter 18.79 RCW and rules adopted thereunder and the nursing assistant scope of practice as defined in chapter 18.88A RCW and the rules adopted thereunder.

(43) "Medication assistance level 2" means assistance with medications as defined by the ((board of)) pharmacy quality assurance commission in chapter 246-888 WAC.

(44) "Nonmedical tasks" means those tasks which do not require clinical judgment and which can be performed by unlicensed individuals. These tasks are ordinarily performed by the patient or client, which if not for the patient or client's cognitive or physical limitation(s), would be completed independently by the patient, client, or family. These tasks may be completed by home health aides or home care aides. These nonmedical tasks include, but are not limited to:

(a) "Ambulation" which means assisting the patient or client to move around. Ambulation includes supervising or guiding the patient or client when walking alone or with the help of a mechanical device such as a walker, assisting with difficult parts of walking such as climbing stairs, supervising or guiding the patient or client if the patient or client is able to propel a wheelchair, pushing of the wheelchair, and providing constant or standby physical assistance to the patient or client if totally unable to walk alone or with a mechanical device.

(b) "Bathing" which means assisting the patient or client to wash. Bathing includes supervising or guiding the patient or client to bathe, assisting the patient or client with difficult tasks such as getting in or out of the tub or washing the back, and completely bathing the patient or client if totally unable to wash self.

(c) "Body care" which means skin care including the application of over the counter ointments or lotions. "Body care" excludes foot care for patients or clients who are diabetic or have poor circulation.

(d) "Feeding" which means assistance with eating. Feeding includes supervising or guiding the patient or client when able to feed self, assisting with difficult tasks such as cutting food or buttering bread, and orally feeding the patient or client when unable to feed self.

(e) "Medication assistance level 2" which means assistance with medications as defined in the ((board of)) pharmacy quality assurance commission rules, chapter 246-888 WAC, and consistent with nursing assistant rules under chapter 18.88A RCW.

(f) "Positioning" which means assisting the patient or client to assume a desired position, and with turning and exercises to prevent complications, such as contractures and pressure sores. Range of motion ordered as part of a physical therapy treatment is not included, unless such activity is authorized in agency policies and procedures and is supervised by a licensed physical therapist in a home health or hospice agency or hospice care center.

(g) "Protective supervision" which means being available to provide safety guidance protection to the patient or client who cannot be left alone due to impaired judgment.

(h) "Toileting" which means helping the patient or client to and from the bathroom, assisting with bedpan routines, using incontinent briefs, cleaning the patient or client after elimination, and assisting the patient or client on and off the toilet.

(i) "Transfer" which means assistance with getting in and out of a bed or wheelchair or on and off the toilet or in and out of the bathtub. Transfer includes supervising or guiding the patient or client when able to transfer, providing steadying, and helping the patient or client when the patient or client assists in own transfer. This does not include transfers when the patient or client is unable to assist in their own transfer or needs assistive devices unless specific training or skills verification has occurred consistent with agency policies and procedures.

(45) "One-time visit" means a single visit by one individual to provide home health, hospice or home care services with no predictable need for continuing visits, not to exceed twenty-four hours.

(46) "On-site" means the location where services are provided.

(47) "Patient" means an individual receiving home health, hospice, or hospice care center services.

(48) "Person" means any individual, business, firm, partnership, corporation, company, association, joint stock association, public or private organization, or the legal successor thereof that employs or contracts with two or more individuals.

(49) "Personnel" means individuals employed and compensated by the licensee.

(50) "Plan of care" means a written document based on assessment of patient or client needs that identifies services to meet these needs.

(51) "Pressure relationships" of air to adjacent areas means:

(a) Positive (P) pressure is present in a room when the:

(i) Room sustains a minimum of 0.001 inches of H2O pressure differential with the adjacent area, the room doors are closed, and air is flowing out of the room; or

(ii) Sum of the air flow at the supply air outlets (in CFM) exceeds the sum of the air flow at the exhaust/return air outlets by at least 70 CFM with the room doors and windows closed;

(b) Negative (N) pressure is present in a room when the:

(i) Room sustains a minimum of 0.001 inches of H2O pressure differential with the adjacent area, the room doors are closed, and air is flowing into the room; or

(ii) Sum of the air flow at the exhaust/return air outlets (in CFM) exceeds the sum of the air flow at the supply air outlets by at least 70 CFM with the room doors and windows closed;

(c) Equal (E) pressure is present in a room when the:

(i) Room sustains a pressure differential range of plus or minus 0.0002 inches of H2O with the adjacent area, and the room doors are closed; or

(ii) Sum of the air flow at the supply air outlets (in CFM) is within ten percent of the sum of the air flow at the exhaust/return air outlets with the room doors and windows closed.

(52) "Professional medical equipment assessment services" means periodic care provided by a licensed nurse, therapist or dietician, within their scope of practice, for patients who are medically stable, for the purpose of assessing the patient's medical response to prescribed professional medical equipment, including, but not limited to, measurement of vital signs, oximetry testing, and assessment of breath sounds and lung function (spirometry).

(53) "Quality improvement" means reviewing and evaluating appropriateness and effectiveness of services provided under this chapter.

(54) "Registered nurse" or "RN" means an individual licensed under chapter 18.79 RCW.

(55) "Service area" means the geographic area in which the department has given approval to a licensee to provide in-home services based on criteria in WAC 246-335-055 (1)(a)(vi). Service areas do not apply to hospice care centers.

(56) "Sink" means one of the following:

(a) "Clinic service sink (siphon jet)" means a plumbing fixture of adequate size and proper design for waste disposal with siphon jet or similar action sufficient to flush solid matter of at least two and one-eighth inch diameter.

(b) "Service sink" means a plumbing fixture of adequate size and proper design for filling and emptying mop buckets.

(c) "Handwash sink" means a plumbing fixture of adequate size and proper design to minimize splash and splatter and permit handwashing without touching fixtures with hands, with adjacent soap dispenser with foot control or equivalent and single service hand drying device.

(57) "Social worker" means an individual regulated under chapter 18.19 or 18.225 RCW.

(58) "Spiritual counseling" means services provided or coordinated by an individual with knowledge of theology, pastoral counseling or an allied field.

(59) "Statement of deficiencies" means a written notice of any violation of chapter 70.127 RCW or the rules adopted thereunder which describes the reasons for noncompliance.

(60) "Statement of charges" means a document which initiates enforcement action against a licensee or applicant and which creates the right to an adjudicative proceeding. The department shall prepare a statement of charges in accordance with WAC 246-10-201.

(61) "Supervisor of direct care services" means an individual responsible for services that support the plan of care provided by an in-home services agency licensed to provide home care services.

(62) "Survey" means an inspection or investigation, announced or unannounced, conducted by the department to evaluate and monitor a licensee's compliance with this chapter.

(63) "Therapist" means an individual who is:

(a) A physical therapist, licensed under chapter 18.74 RCW;

(b) A respiratory therapist, licensed under chapter 18.89 RCW;

(c) An occupational therapist, licensed under chapter 18.59 RCW; or

(d) A speech therapist licensed under chapter 18.35 RCW.

(64) "Therapy assistant" means a licensed occupational therapy assistant defined under chapter 18.59 RCW or physical therapist assistant defined under chapter 18.74 RCW.

(65) "Volunteer" means an individual who provides direct care to a patient or client and who:

(a) Is not compensated by the in-home services licensee; and

(b) May be reimbursed for personal mileage incurred to deliver services.

(66) "WISHA" means the Washington Industrial Safety and Health Act, chapter 49.17 RCW.

The licensee must assure that all pharmaceutical services are provided consistent with chapter 246-865 WAC and the following requirements:

(1) Pharmaceutical services must be available twenty-four hours per day to provide medications and supplies through a licensed pharmacy;

(2) A pharmacist must provide sufficient on-site consultation to ensure that medications are ordered, prepared, disposed, secured, stored, accounted for and administered in accordance with the policies of the center and chapter 246-865 WAC;

(3) Medications must be administered only by individuals authorized to administer medications;

(4) Medications may be self-administered or administered by a designated family member in accordance with WAC 246-865-060 (7)(f);

(5) Drugs for external use must be stored apart from drugs for internal use;

(6) Poisonous or caustic medications and materials including housekeeping and personal grooming supplies must show proper warning or poison labels and must be stored safely and separately from other medications and food supplies;

(7) The hospice care center must maintain an emergency medication kit appropriate to the needs of the center;

(8) Medications brought into the hospice care center by patients to be administered by an appropriate health care professional while in the center must be specifically ordered by an authorizing practitioner and must be identified by a pharmacist or licensed nurse with pharmacist consultation prior to administration;

(9) Drugs requiring refrigeration must be kept in a separate refrigeration unit;

(10) Schedule II - IV controlled substances must be:

(a) Kept in a separate keyed storage unit; and

(b) When heat sensitive, be kept in a locked refrigeration unit;

(11) Schedule II - IV controlled substances no longer needed by the patient must be disposed in compliance with chapter 246-865 WAC;

(12) The hospice care center must provide for continuation of drug therapy for patients when temporarily leaving the center in accordance with WAC 246-865-070;

(13) If planning to use an automated drug distribution device, the hospice care center must first receive ((board of)) pharmacy quality assurance commission approval; and

(14) If planning to provide pharmacy services beyond the scope of services defined in this section, the hospice care center must comply with the requirements for a licensed pharmacy in chapter 246-869 WAC.

The licensee is responsible for the control and use of all medications within the RTF, including:

(1) Ensuring policies and procedures and medication protocols are developed, approved, reviewed and implemented by licensed health care providers, administration and pharmacist (as needed). The policies and procedures must be consistent with the rules of the department and the ((department's board of)) pharmacy quality assurance commission and address all aspects of medication administration, including the following:

(a) Timely procurement;

(b) Medication administration;

(c) Prescribing;

(d) Proper storage conditions addressing security, safety, sanitation, temperature, light, moisture and ventilation;

(e) Use of nonprescription drugs:

(i) List of drugs available;

(ii) Parameters of use;

(f) Receipt;

(g) Proper labeling;

(h) Disposal;

(i) Medication brought into RTF by a resident;

(j) Accountability;

(k) Starter supply of psychotropic, detoxification and emergency drugs not for a specific resident;

(l) Emergency allergy response kit of prepackaged medications and supplies for the treatment of anaphylactic shock; and

(m) Medications for short term authorized absence (pass) from the RTF, where applicable.

(2) Establishing and maintaining of an organized system that ensures accuracy in receiving, transcribing and implementing policies and procedures for medication administration, including ensuring residents receive the correct medication, dosage, route, time, and reason.

(3) Documentation of all medications administered or self-administered, including the following data:

(a) Name and dosage of medication;

(b) Start/stop date;

(c) Time;

(d) Route;

(e) Staff or resident initials indicating medication was administered, self-administered or issued;

(f) Notation if medication was refused, held, wasted or not administered or self-administered;

(g) Allergies;

(h) Resident response to medication when given as necessary or as needed (PRN);

(i) Medical staff notification of errors, adverse effects, side effects; and

(j) Within established parameters for nonprescription drugs.

(4) Ensuring written orders are signed by an authorized health care provider with prescriptive authority for all legend drugs and vaccines. Verbal orders for legend drugs and vaccines must be signed by the prescriber as soon as possible, but no later than seven days after the verbal order.

(5) Ensuring use of nonprescription drugs that are self-administered are:

(a) Within parameters established for nonprescription drugs; and

(b) According to established list.

(6) Having a current established drug reference resource available for use by RTF staff.