WSR 08-20-139

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed October 1, 2008, 11:43 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 07-17-173.

Title of Rule and Other Identifying Information: Chapter 246-320 WAC, Hospital licensing rules (operation standards only).

The following sections of the Washington Administrative Code are repealed: WAC 246-320-025 On-site licensing survey, 246-320-045 Application for license -- License expiration dates -- Notice of decision -- Adjudicative proceeding, 246-320-065 Exemptions, alternative methods, and interpretations, 246-320-085 Single license to cover two or more buildings--When permissible, 246-320-105 Criminal history, disclosure, and background inquiries, 246-320-125 Governance, 246-320-145 Leadership, 246-320-165 Management of human resources, 246-320-185 Medical staff, 246-320-205 Management of information, 246-320-225 Improving organizational performance, 246-320-245 Patient rights and organizational ethics, 246-320-265 Infection control program, 246-320-285 Pharmacy services, 246-320-305 Food and nutrition services, 246-320-325 Laboratory, imaging, and other diagnostic, treatment or therapeutic services, 246-320-345 Inpatient care services, 246-320-365 Specialized patient care services, 246-320-370 Emergency contraception, 246-320-385 Outpatient care services, 246-320-405 Management of environment for care, 246-320-615 Pharmacy, and 246-320-990 Fees.

The following sections of the Washington Administrative Code are revised: WAC 246-320-001 Purpose and applicability of chapter and 246-320-010 Definitions.

The following sections of the Washington Administrative Code are added: WAC 246-320-011 Department responsibilities -- Licensing -- Adjudicative proceeding, 246-320-016 Department responsibilities -- On-site survey and complaint investigation, 246-320-021 Department responsibilities -- General, 246-320-026 Department role -- Exemptions, interpretations, alternative methods, 246-320-031 Criminal history, disclosure, and background inquiries -- Department responsibility, 246-320-036 Department responsibility, refund initial license fee, 246-320-101 Application for license -- Annual update of hospital information -- License renewal -- Right to contest a license decision, 246-320-106 Application for license, specialty hospital -- Annual update of hospital information -- License renewal -- Right to contest a license decision, 246-320-111 Hospital responsibilities, 246-320-116 Specialty hospital responsibilities, 246-320-121 Requests for exemptions, interpretations, alternative methods, 246-320-126 Criminal history, disclosure, and background inquiries -- Hospital responsibility, 246-320-131 Governance, 246-320-136 Leadership, 246-320-141 Patient rights and organizational ethics, 246-320-146 Adverse events, 246-320-151 Reportable events, 246-320-156 Management of human resources, 246-320-161 Medical staff, 246-320-166 Management of information, 246-320-171 Improving organizational performance, 246-320-176 Infection control program, 246-320-199 Fees, 246-320-201 Food and nutrition services, 246-320-206 Linen and laundry services, 246-320-211 Pharmaceutical services, 246-320-216 Laboratory, imaging, and other diagnostic, treatment or therapeutic services, 246-320-221 Safe patient handling, 246-320-226 Patient care services, 246-320-231 Patient care unit or area, 246-320-236 Surgical services, 246-320-241 Anesthesia services, 246-320-246 Recovery care, 246-320-251 Obstetrical services, 246-320-256 Neonatal and pediatric services, 246-320-261 Critical or intensive care services, 246-320-266 Alcohol and chemical dependency services, 246-320-271 Psychiatric services, 246-320-276 Long-term care services, 246-320-281 Emergency services, 246-320-286 Emergency contraception, 246-320-291 Dialysis services, and 246-320-296 Management of environment for care.

Hearing Location(s): Department of Health, Point Plaza East, 310 Israel Road S.E., Rooms 152 and 153, Tumwater, WA 98501, on November 17, 2008, at 9:30 a.m.

Date of Intended Adoption: December 10, 2008.

Submit Written Comments to: John Hilger, Department of Health, P.O. Box 47852, Olympia, WA 98504-7852, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-2901, by November 17, 2008.

Assistance for Persons with Disabilities: Contact John Hilger by November 10, 2008, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of the proposal is to amend, repeal, and add new sections to chapter 246-320 WAC to promote safe and adequate care of individuals in hospitals. The proposal is in response to 2005 passed legislation (SSB 5492, HB 1533, and SB 5065) which amended chapter 70.41 RCW and directed the department to ensure hospitals provide notification of unanticipated outcomes, report restrictions or termination of health care provider's licenses, and required the department to inspect hospitals at least every eighteen months. In addition, the proposal updates language and terminology to represent current standards and practices, as some sections of chapter 246-320 WAC have not been revised since 1998. The anticipated effects will be quality improvement and assurance of statewide hospitals, and thereby increase patient safety and positive health outcomes.

Reasons Supporting Proposal: Reasons supporting the proposal are (1) increased quality improvement/assurance of Washington hospitals by the department; (2) assuring information is provided to the public pursuant to RCW 7.70.065 to inform the public of unanticipated outcomes; (3) ensuring the reporting by hospitals of any adverse actions taken against clinical privileges of health care providers in order to inform and protect the public; (4) updating rule language to reflect current standards and practices; and (5) clarifying and organizing sections of WAC for better readability by hospitals and the general public.

Statutory Authority for Adoption: Chapter 70.41 RCW and RCW 43.70.040.

Statute Being Implemented: Chapter 70.41 RCW.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Department of health, governmental.

Name of Agency Personnel Responsible for Drafting and Implementation: Byron Plan, Tumwater, Washington, (360) 236-2916; and Enforcement: Steven M. Saxe, Tumwater, Washington, (360) 236-2902.

No small business economic impact statement has been prepared under chapter 19.85 RCW. Per chapter 19.85 RCW no small business economic impact statement is required for rules that do not impose more than minor costs on small businesses within an industry affected by the rule. The proposed rules do not impact small businesses.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting John Hilger, Department of Health, P.O. Box 47852, Olympia, WA 98504, phone (360) 236-2929, fax (360) 236-2901, e-mail john.hilger@doh.wa.gov.

September 30, 2008

Mary C. Selecky

Secretary

OTS-1533.4


AMENDATORY SECTION(Amending WSR 99-04-052, filed 1/28/99, effective 3/10/99)

WAC 246-320-001   Purpose and applicability of chapter.   ((This chapter is adopted by the Washington state department of health to implement the provisions of chapter 70.41 RCW and establish minimum health and safety requirements for the operation, maintenance, and construction of acute care hospitals.

(1) Compliance with the regulations in this chapter does not constitute release from the requirements of applicable state and local codes and ordinances. Where regulations in this chapter exceed other codes and ordinances, the regulations in this chapter will apply:

(2) The department will review references to codes and regulations in this chapter, and:

(a) Update as necessary; and

(b) Adopt a revised list of referenced standards, if required.)) This chapter is adopted by the Washington state department of health to implement chapter 70.41 RCW and establish minimum health and safety requirements for the licensing, inspection, operation, maintenance, and construction of hospitals.

(1) Compliance with the regulations in this chapter does not constitute release from the requirements of applicable federal, state and local codes and ordinances. Where regulations in this chapter exceed other codes and ordinances, the regulations in this chapter will apply.

(2) The department will update or adopt references to codes and regulations in this chapter as necessary.

[Statutory Authority: RCW 70.41.030 and 43.70.040. 99-04-052, 246-320-001, filed 1/28/99, effective 3/10/99.]


AMENDATORY SECTION(Amending WSR 08-14-023, filed 6/20/08, effective 7/21/08)

WAC 246-320-010   Definitions.   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 under circumstances indicating the health, welfare, and safety of the patient is harmed. Person "legally responsible" will include a parent, guardian, or an individual to whom parental or guardian responsibility is delegated (e.g., teachers, providers of residential care and treatment, and providers of day care):

(a) "Physical abuse" means damaging or potentially damaging nonaccidental 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 problems, physical manifestations, disordered or delayed development.

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

(3) "Alcoholism" means an illness characterized by lack of control as to the consumption of alcoholic beverages, or the consumption of alcoholic beverages to the extent an individual's health is substantially impaired or endangered, or his or her social or economic function is substantially disrupted.

(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) process established by a hospital for obtaining appropriate and necessary information about each individual seeking entry into a health care setting or service; and (c) information to match an individual's need with the appropriate setting and intervention.

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

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

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

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

(10) "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.

(11) "Double-checking" means verification of patient identity, agent to be administered, route, quantity, rate, time, and interval of administration by two persons legally qualified to administer such agent prior to administration of the agent.

(12) "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.

(13) "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.

(14) "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.

(15) "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 and the time and place care and treatment is to be given.

(16) "Family" means individuals important to and designated by a patient who need not be relatives.

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

(18) "High-risk infant" means an infant, regardless of gestational age or birth weight, whose extrauterine existence is compromised by a number of factors, prenatal, natal, or postnatal needing special medical or nursing care.

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

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

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

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

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

(f) 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.

(g) 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.

(20) "Individualized treatment plan" means a written 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.

(21) "Infant" means a baby or very young child up to one year of age.

(22) "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.

(23) "Licensed practical nurse," abbreviated LPN, means an individual licensed under provisions of chapter 18.78 RCW.

(24) "Maintenance" means the work of keeping something in suitable condition.

(25) "Medical staff" means physicians and may include other practitioners appointed by the governing authority to practice within the parameters of the governing authority and medical staff bylaws.

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

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

(28) "Neglect" means mistreatment or maltreatment; an act or omission evincing; a serious disregard of consequences of a 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 necessary for patient level of development, inadequate food, clothing, or cleanliness.

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

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

(30) "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.

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

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

(b) Alterations.

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

(33) "Operating room (OR)" means a room within the surgical department intended for invasive and noninvasive procedures requiring anesthesia.

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

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

(36) "Pharmacist" means an individual licensed by the state board of pharmacy to engage in the practice of pharmacy under the provisions of chapter 18.64 RCW as now or hereafter amended.

(37) "Pharmacy" means the central area in a hospital where drugs are stored and are issued to hospital departments or where prescriptions are filled.

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

(39) "Prescription" means an order for drugs or devices issued by a practitioner duly authorized by law or rule in the state of Washington to prescribe drugs or devices in the course of his or her professional practice for a legitimate medical purpose.

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

(41) "Protocols" and "standing order" mean written descriptions of actions and interventions for implementation by designated hospital personnel under defined circumstances and authenticated by a legally authorized person under hospital policy and procedure.

(42) "Psychiatric service" means the treatment of patients pertinent to the psychiatric diagnosis whether or not the hospital maintains a psychiatric unit.

(43) "Recovery unit" means a special physical and functional area for the segregation, concentration, and close or continuous nursing observation and care of patients for a period of less than twenty-four hours immediately following anesthesia, obstetrical delivery, surgery, or other diagnostic or treatment procedures which may produce shock, respiratory obstruction or depression, or other serious states.

(44) "Registered nurse" means an individual licensed under the provisions of chapter 18.79 RCW and practicing in accordance with the rules and regulations promulgated thereunder.

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

(46) "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.

(47) "Seclusion room" means a small, secure room specifically designed and organized for temporary placement, care, and observation of one patient and for an environment with minimal sensory stimuli, maximum security and protection, and visual observation of the patient by authorized personnel and staff. Doors of seclusion rooms are provided with staff-controlled locks.

(48) "Sexual assault" has the same meaning as in RCW 70.125.030.

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

(50) "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 or an organ;

(b) Suture or other repair of tissue or an organ 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 with use of anesthetizing agents.

(51) "Surrogate decision-maker" means an individual appointed to act on behalf of another. Surrogates make decisions only when an individual is without capacity or has given permission to involve others.

(52) "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.

(53) "Victim of sexual assault" means a person who alleges or is alleged to have been sexually assaulted and who presents as a patient.)) (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) "Adverse health event" or "adverse event" means the list of Serious Reportable Events adopted by the National Quality Forum in 2002 (and updates in 2006), in its consensus report on serious reportable events in health care.

(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) "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.

(5) "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.

(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 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.

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

(8) "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. This does not include stretchers, exam tables, operating tables, well baby bassinets, labor bed, and labor-delivery-recovery beds.

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

(10) "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.

(11) "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.

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

(13) "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.

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

(15) "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.

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

(17) "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.

(18) "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.

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

(20) "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.

(21) "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.

(22) "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.

(23) "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.

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

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

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

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

(28) "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;

(h) 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.

(29) "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.

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

(31) "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.

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

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

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

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

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

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

(38) "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.

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

(40) "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.

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

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

(b) Renovation; or

(c) Alteration.

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

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

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

(45) "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.

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

(47) "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.

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

(49) "Pharmacist" means an individual licensed by the state board of pharmacy chapter 18.64 RCW.

(50) "Pharmacy" means every place properly licensed by the board of pharmacy where the practice of pharmacy is conducted.

(51) "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.

(52) "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.

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

(54) "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.

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

(56) "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.

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

(58) "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.

(59) "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.

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

(61) "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.

(62) "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.

(63) "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.

(64) "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.

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

(66) "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.

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

(68) "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.

(69) "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.

(70) "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.

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

(72) "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, boarding home 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.

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

[Statutory Authority: Chapter 70.41 RCW. 08-14-023, 246-320-010, filed 6/20/08, effective 7/21/08. Statutory Authority: RCW 70.41.350 and 70.41.030. 04-11-057, 246-320-010, filed 5/17/04, effective 6/17/04. Statutory Authority: RCW 70.41.030 and 43.70.040. 99-04-052, 246-320-010, filed 1/28/99, effective 3/10/99.]


NEW SECTION
WAC 246-320-011   Department responsibilities -- Licensing -- Adjudicative proceeding.   This section identifies the actions and responsibilities of the department for licensing hospitals.

(1) Before issuing an initial license, the department will verify compliance with chapter 70.41 RCW and this chapter which includes, but is not limited to:

(a) Approval of construction documents;

(b) Receipt of a certificate of need as provided in chapter 70.38 RCW;

(c) Approval by the local jurisdiction of all local codes and ordinances and the permit to occupy;

(d) Approval of the initial license application;

(e) Receipt of the correct license fee;

(f) Compliance with the on-site survey conducted by the state fire marshal required in RCW 70.41.080; and

(g) Conduct an on-site licensing survey in accordance with WAC 246-320-016.

(2) The department may issue a license to include two or more buildings, if the applicant:

(a) Meets the requirements listed in subsection (1) of this section;

(b) Operates the buildings as an integrated system with:

(i) Governance by a single authority over all buildings or portions of buildings;

(ii) A single medical staff for all hospital facilities; and

(iii) Use all policies and procedures for all facilities and departments.

(c) Arranges for safe and appropriate transport of patients between all facilities and buildings.

(3) Before reissuing a license, the department will:

(a) Verify compliance with the on-site survey conducted by the state fire marshal required in RCW 70.41.080;

(b) Review and accept the annual hospital update information documentation;

(c) Assure receipt of the correct annual fee; and

(d) Reissue licenses as often as necessary each calendar year so that approximately one-third of the hospital licenses expire on the last day of the calendar year.

(4) The department may issue a provisional license to allow the operation of a hospital, if the department determines that the applicant or licensed hospital failed to comply with chapter 70.41 RCW or this chapter.

(5) The department may deny, suspend, modify, or revoke a license when it finds an applicant or hospital has failed or refused to comply with chapter 70.41 RCW or this chapter. The department's notice of a license denial, suspension, modification, or revocation will be consistent with RCW 43.70.115. The proceeding is governed by the Administrative Procedure Act chapter 34.05 RCW, this chapter, and chapters 246-08 and 246-10 WAC. If this chapter conflicts with chapter 246-08 or 246-10 WAC, this chapter governs.

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NEW SECTION
WAC 246-320-016   Department responsibilities -- On-site survey and complaint investigation.   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) Notify the hospital at least four weeks prior to the scheduled date of the on-site survey;

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

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

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

(f) Notify the hospital when the hospital submitted plan of correction adequately addresses the survey findings.

(g) 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.

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NEW SECTION
WAC 246-320-021   Department responsibilities -- General.   This section outlines the department's responsibility to post information to the agency web site and time frames to respond to interpretations, exemptions and alternative methods.

The department will:

(1) Post to the agency web site a list of the most frequent problems identified during hospital surveys and complaint investigations in accordance with RCW 70.41.045.

(2) Respond within thirty calendar days to a hospital's request for an exemption or use of an alternative as provided for in WAC 246-320-026.

(3) Respond within thirty calendar days to a hospital's request for an interpretation as provided for in WAC 246-320-026.

(4) Maintain hospital provided information confidentially according to the Public Disclosure Act, chapters 42.17 and 42.56 RCW, RCW 70.41.150, 70.41.200, and 70.41.210.

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NEW SECTION
WAC 246-320-026   Department role -- Exemptions, interpretations, alternative methods.   This section outlines the department's responsibilities and actions in response to requests for interpretations, exemptions and alternative methods.

(1) The department may exempt a hospital from complying with portions of this chapter when:

(a) The exemption will not change the purpose and intent of chapter 70.41 RCW or this chapter;

(b) Patient safety, health or well being is not threatened;

(c) Fire and life safety regulations, infection control standards or other codes or regulations would not be reduced; and

(d) Any structural integrity of the building would not occur.

(2) The department will write an interpretation of a rule after receiving complete information relevant to the interpretation.

(3) The department may approve a hospital to use alternative materials, designs, and methods if the documentation and supporting information:

(a) Meets the intent and purpose of these rules; and

(b) Is equivalent to the methods prescribed in this chapter.

(4) The department will keep copies of each exemption, alternative, or interpretation issued.

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NEW SECTION
WAC 246-320-031   Criminal history, disclosure, and background inquiries -- Department responsibility.   This section outlines the department's responsibilities to review and use criminal history, disclosure and background information.

(1) The department will:

(a) Review hospital records required under WAC 246-320-126;

(b) Investigate allegations of noncompliance by hospitals with RCW 43.43.830 through 43.43.842; and

(c) Use information collected under this section only to determine hospital licensure or relicensure eligibility under RCW 43.43.842.

(2) The department may require the hospital to complete additional disclosure statements or background inquiries, if the department believes offenses specified under RCW 43.43.830 have occurred since the previous disclosure statement or background inquiry, for any person having unsupervised access to children, vulnerable adults, and developmentally disabled adults.

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NEW SECTION
WAC 246-320-036   Department responsibility, refund initial license fee.   This section outlines the department's actions regarding a request for refund of an initial licensing fee.

The department will, upon request of an applicant:

(1) Refund two-thirds of the initial fee, less a fifty dollar processing charge provided the department did not conduct an on-site survey or give technical assistance.

(2) Refund one-third of the initial fee, less a fifty dollar processing charge when the department conducted an on-site survey or gave technical assistance and did not issue a license.

(3) The department will not refund an initial license fee if:

(a) The department conducted more than one on-site visit;

(b) One year has passed since the department received an initial licensure application;

(c) One year has passed since the department received an initial application and the department has not issued the license because the applicant failed to complete requirements for licensure; or

(d) The amount to be refunded is one hundred dollars or less.

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LICENSING
NEW SECTION
WAC 246-320-101   Application for license -- Annual update of hospital information -- License renewal -- Right to contest a license decision.   This section identifies the applicant or hospital actions and responsibilities for obtaining a license.

(1) Initial license. An applicant must submit an application packet and fee to the department at least sixty days before the intended opening date of the new hospital.

(2) Annual update. Before November 30 of each calendar year, a licensed hospital must submit to the department the hospital update documentation and fee.

(3) License renewal. Before November 30 of the year the license expires, a licensed hospital must submit to the department the hospital update documentation, fee and the results of the most recent on-site survey conducted by the state fire marshal.

(4) An applicant or hospital has the right to contest a license decision by:

(a) Sending a written request for an adjudicative proceeding within twenty-eight days of receipt of the department's licensing decision showing proof of receipt with the office of the Adjudicative Service Unit, Department of Health, P.O. Box 47879, Olympia, WA 98504-7879; and

(b) Including as part of the written request:

(i) A specific statement of the issues and law involved;

(ii) The grounds for contesting the department decision; and

(iii) A copy of the contested department decision.

(c) The adjudicative proceeding is governed by the Administrative Procedure Act chapter 34.05 RCW, this chapter, and chapters 246-08 and 246-10 WAC. If this chapter conflicts with chapter 246-08 or 246-10 WAC, this chapter governs.

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NEW SECTION
WAC 246-320-106   Application for license, specialty hospital -- Annual update of hospital information -- License renewal -- Right to contest a license decision.   This section identifies the applicant or specialty hospital actions and responsibilities for obtaining a license.

(1) Initial license. An applicant must submit an application packet and fee to the department at least sixty days before the intended opening date of the specialty hospital.

(2) Annual update. Before November 30 of each calendar year, a licensed specialty hospital must submit to the hospital the specialty hospital update information and fee.

(3) License renewal. Before November 30 of the year the license expires, a licensed specialty hospital must submit to the department the hospital update documentation, fee and the results of the most recent on-site survey conducted by the state fire marshal.

(4) An applicant or specialty hospital has the right to contest a license decision by:

(a) Sending a written request for an adjudicative proceeding within twenty-eight days of receipt of the department's licensing decision showing proof of receipt with the office of the Adjudicative Service Unit, Department of Health, P.O. Box 47879, Olympia, WA 98504-7879; and

(b) Including as part of the written request:

(i) A specific statement of the issues and law involved;

(ii) The grounds for contesting the department decision; and

(iii) A copy of the contested department decision.

(c) The adjudicative proceeding is governed by the Administrative Procedure Act chapter 34.05 RCW, this chapter, and chapters 246-08 and 246-10 WAC. If this chapter conflicts with chapter 246-08 and 246-10 WAC, this chapter governs.

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NEW SECTION
WAC 246-320-111   Hospital responsibilities.   This section identifies a hospital obligation, actions and responsibilities to comply with the hospital law and rules.

(1) Hospitals must:

(a) Comply with chapter 70.41 RCW and this chapter;

(b) Only set up inpatient beds within the licensed bed capacity approved by the department or the Medicare provider agreement; and

(c) Receive approval for additional inpatient beds as required in chapter 70.38 RCW before exceeding department approved bed capacity.

(2) A hospital accredited by the Joint Commission or American Osteopathic Association must:

(a) Notify the department of an accreditation survey within two business days following completion of the survey; and

(b) Notify the department in writing of the accreditation decision and any changes in accreditation status within thirty calendar days of receiving the accreditation report.

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NEW SECTION
WAC 246-320-116   Specialty hospital responsibilities.   This section identifies a specialty hospital obligation, actions and responsibilities to comply with the hospital law and rules.

Specialty hospitals must:

(1) Comply with chapter 70.41 RCW and this chapter;

(2) Only set up inpatient beds within the licensed bed capacity approved by the department or the Medicare provider agreement;

(3) Receive approval for additional inpatient beds as required in chapter 70.38 RCW before exceeding department approved bed capacity;

(4) Provide appropriate discharge planning;

(5) Provide staff proficient in resuscitation and respiration maintenance twenty-four hours per day, seven days per week;

(6) Participate in the Medicare and Medicaid programs and provide at least the same percentage of services to Medicare and Medicaid beneficiaries, as a percent of gross revenues, as the lowest percentage of services provided to Medicare and Medicaid beneficiaries by a general hospital in the same health service area. The lowest percentage of services provided to Medicare and Medicaid beneficiaries shall be determined by the department in consultation with the general hospitals in the health service area but shall not be the percentage of Medicare and Medicaid services of a hospital that serves primarily members of a particular health plan or government sponsor;

(7) Provide at least the same percentage of charity care, as a percent of gross revenues, as the lowest percentage of charity care provided by a general hospital in the same health service area. The lowest percentage of charity care shall be determined by the department in consultation with the general hospitals in the health service area but shall not be the percentage of charity care of a hospital that serves primarily members of a particular health plan or government sponsor;

(8) Require any physician owner to:

(a) In accordance with chapter 19.68 RCW, disclose a financial interest in the specialty hospital and provide a list of alternative hospitals before referring a patient to the specialty hospital; and

(b) If the specialty hospital does not have an intensive care unit, notify the patient that if intensive care services are required, the patient must be transferred to another hospital;

(9) Provide emergency services twenty-four hours per day, seven days per week, in a designated area of the hospital, and comply with requirements for emergency facilities that are established by the department;

(10) Establish procedures to stabilize a patient with an emergency medical condition until the patient is transported or transferred to another hospital if emergency services cannot be provided at the specialty hospital to meet the needs of the patient in an emergency;

(11) Maintain a transfer agreement with a general hospital in the same health service area that establishes a process for patient transfers in a situation in which the specialty hospital cannot provide continuing care for a patient because of the specialty hospital's scope of services and for the transfer of patients; and

(12) Accept the transfer of patients from general hospitals when the patients require the category of care or treatment provided by the specialty hospital.

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NEW SECTION
WAC 246-320-121   Requests for exemptions, interpretations, alternative methods.   This section outlines a process to request an exemption, interpretation, or approval to use an alternative method. This section is not intended to prevent use of systems, materials, alternate design, or methods of construction as alternatives to those prescribed by this chapter.

(1) A hospital requesting exemption from this chapter must:

(a) Send a written request to the department;

(b) Include in the request:

(i) The specific section of this chapter to be exempted;

(ii) Explain the reasons for requesting the exemption; and

(iii) When appropriate, provide documentation to support the request.

(2) A hospital or person requesting an interpretation of a rule in this chapter must:

(a) Send a written request to the department;

(b) Include in the request:

(i) The specific section of this chapter to be interpreted;

(ii) Explain the reason or circumstances for requesting the interpretation; and

(iii) Where or how the rule is being applied.

(c) Provide additional information when required by the department.

(3) A hospital requesting use of alternative materials, design, and methods must:

(a) Send a written request to the department; and

(b) Explain and support with technical documentation the reasons the department should consider the request.

(4) The hospital must keep and make available copies of each exemption, alternative, or interpretation received from the department.

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NEW SECTION
WAC 246-320-126   Criminal history, disclosure, and background inquiries -- Hospital responsibility.   This section outlines the requirements for hospitals to conduct criminal history background inquiries for all medical staff, employees or prospective employees who have or may have unsupervised access to children, vulnerable adults, and developmentally disabled adults.

Hospitals must:

(1) Require a disclosure statement according to RCW 43.43.834 for each prospective employee, volunteer, contractor, student, and any other person associated with the licensed hospital with unsupervised access to:

(a) Children under sixteen years of age;

(b) Vulnerable adults as defined under RCW 43.43.830; and

(c) Developmentally disabled individuals;

(2) Require a Washington state patrol background inquiry according to RCW 43.43.834 for each prospective employee, volunteer, contractor, student, and any other person applying for association with the licensed hospital before allowing unsupervised access to:

(a) Children under sixteen years of age;

(b) Vulnerable adults as defined under RCW 43.43.830; and

(c) Developmentally disabled individuals.

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NEW SECTION
WAC 246-320-131   Governance.   This section provides organizational guidance and oversight responsibilities of hospital resources and staff to support safe patient care.

For the purposes of this section "practitioner" means pharmacists as defined in chapter 18.64 RCW; advanced registered nurse practitioners as defined in chapter 18.79 RCW; dentists as defined in chapter 18.32 RCW; naturopaths as defined in chapter 18.36A RCW; optometrists as defined in chapter 18.53 RCW; osteopathic physicians and surgeons as defined in chapter 18.57 RCW; osteopathic physicians' assistants as defined in chapter 18.57A RCW; physicians as defined in chapter 18.71 RCW; physician assistants as defined in chapter 18.71A RCW; podiatric physicians and surgeons as defined in chapter 18.22 RCW; and psychologists as defined in chapter 18.83 RCW.

The governing authority must:

(1) Establish and review governing authority policies including requirements for:

(a) Reporting practitioners according to RCW 70.41.210;

(b) Informing patients of any unanticipated outcomes according to RCW 70.41.380;

(c) Establishing and approving a performance improvement plan;

(d) Providing organizational management and planning;

(e) Reporting adverse events and conducting root cause analyses according to RCW 70.56.020;

(f) Providing a patient and family grievance process including a time frame for resolving each grievance;

(g) Defining who can give and receive patient care orders that are consistent with professional licensing laws; and

(h) Providing communication and conflict resolution between the medical staff and the governing authority;

(2) Establish a process for selecting and periodically evaluating a chief executive officer or administrator;

(3) Appoint and approve a medical staff;

(4) Require written or electronic orders, authenticated by a legally authorized practitioner, for all drugs, intravenous solutions, blood, medical treatments, and nutrition; and

(5) Approve and periodically review bylaws, rules, and regulations adopted by the medical staff before they become effective.

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NEW SECTION
WAC 246-320-136   Leadership.   This section describes leadership's role in assuring care is provided consistently throughout the hospital and according to patient and community needs.

The hospital leaders must:

(1) Appoint or assign a nurse at the executive level to:

(a) Direct the nursing services; and

(b) Approve patient care policies, nursing practices and procedures;

(2) Establish hospital-wide patient care services appropriate for the patients served and available resources which includes:

(a) Approving department specific scope of services;

(b) Integrating and coordinating patient care services;

(c) Standardizing the uniform performance of patient care processes;

(d) Establishing a hospital-approved procedure for double checking certain drugs, biologicals, and agents by appropriately licensed personnel; and

(e) Ensuring immediate access and appropriate dosages for emergency drugs;

(3) Adopt and implement policies and procedures which define standards of care for each specialty service;

(4) Provide practitioner oversight for each specialty service with experience in those specialized services. Specialized services include, but are not limited to:

(a) Surgery;

(b) Anesthesia;

(c) Obstetrics;

(d) Neonatal;

(e) Pediatrics;

(f) Critical or intensive care;

(g) Alcohol or substance abuse;

(h) Psychiatric;

(i) Emergency; and

(j) Dialysis;

(5) Provide all patients access to safe and appropriate care;

(6) Adopt and implement policies and procedures addressing patient care and nursing practices;

(7) Require that individuals conducting business in the hospital comply with hospital policies and procedures;

(8) Establish and implement processes for:

(a) Gathering, assessing and acting on information regarding patient and family satisfaction with the services provided;

(b) Posting the complaint hotline notice according to RCW 70.41.330; and

(c) Providing patients written billing statements according to RCW 70.41.400;

(9) Plan, promote, and conduct organization-wide performance-improvement activities according to WAC 246-320-171;

(10) Adopt and implement policies and procedures concerning abandoned babies and hospitals as a safe haven according to RCW 13.34.360;

(11) Adopt and implement policies and procedures to require that suspected abuse, assault, sexual assault or other possible crime is reported within forty-eight hours to local police or the appropriate law enforcement agency according to RCW 26.44.030.

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NEW SECTION
WAC 246-320-141   Patient rights and organizational ethics.   The purpose of this section is to improve patient care and outcomes by respecting every patient and maintaining ethical relationships with the public.

Hospitals must:

(1) Adopt and implement policies and procedures that define each patient's right to:

(a) Be treated and cared for with dignity and respect;

(b) Confidentiality, privacy, security, complaint resolution, spiritual care, and communication. If communication restrictions are necessary for patient care and safety, the hospital must document and explain the restrictions to the patient and family;

(c) Be protected from abuse and neglect;

(d) Access protective services;

(e) Complain about their care and treatment without fear of retribution or denial of care;

(f) Timely complaint resolution;

(g) Be involved in all aspects of their care including:

(i) Refusing care and treatment; and

(ii) Resolving problems with care decisions;

(h) Be informed of unanticipated outcomes according to RCW 70.41.380;

(i) Be informed and agree to their care;

(j) Family input in care decisions;

(k) Have advance directives and for the hospital to respect and follow those directives;

(l) Request no resuscitation or life-sustaining treatment;

(m) End of life care;

(n) Donate organs and other tissues according to RCW 68.50.500 and 68.50.560 including:

(i) Medical staff input; and

(ii) Direction by family or surrogate decision makers;

(2) Provide each patient a written statement of patient rights from subsection (1) of this section;

(3) Adopt and implement policies and procedures to identify patients who are potential organ and tissue donors;

(4) Adopt and implement policies and procedures to address research, investigation, and clinical trials including:

(a) How to authorize research;

(b) Require staff to follow informed consent laws; and

(c) Not hindering a patient's access to care if a patient refuses to participate.

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NEW SECTION
WAC 246-320-146   Adverse health events and incident reporting system.   The purpose of this section is to outline each hospital's responsibilities for reporting and addressing adverse events. In this section, "serious disability" means a physical or mental impairment that substantially limits the major life activities of a patient.

Hospitals must:

(1) Notify the department whenever any of the following adverse events as defined by the National Quality Forum, Serious Reportable Events in Health Care occur:


1. Surgery performed on the wrong body part;
2. Surgery performed on the wrong patient;
3. Wrong surgical procedure performed on a patient;
4. Unintended retention of a foreign object in a patient after surgery or other procedure;
5. Intraoperative or immediately postoperative death in an ASA Class 1 patient;
6. Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the health care facility;
7. Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended;
8. Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a health care facility;
9. Infant discharged to wrong person;
10. Patient death or serious disability associated with patient elopement (disappearance);
11. Patient suicide, or attempted suicide resulting in serious disability, while being cared for in a health care facility;
12. Patient death or serious disability associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration);
13. Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products;
14. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in the health care facility;
15. Patient death or serious disability associated with hypoglycemia, the onset of which occurs while the patient is being cared for in a health care facility;
16. Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinimia neonates;
17. Stage 3 or 4 pressure ulcers acquired after admission to a health care facility;
18. Patient death or serious disability due to spinal manipulative therapy;
19. Patient death or serious disability associated with electric shock or electric cardioversion while being cared for in a health care facility;
20. Any incident in which a line designed for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances;
21. Patient death or serious disability associated with a burn incurred from any source while being cared for in a health care facility;
22. Patient death or serious disability associated with a fall while being cared for in a health care facility;
23. Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health care facility;
24. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider;
25. Abduction of a patient of any age;
26. Sexual assault on a patient within or on the grounds of a health care facility;
27. Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a health care facility; and
28. Artificial insemination with the wrong donor sperm or egg;

(2) Notify the department within forty-eight hours of confirmation by the hospital when any adverse event has occurred. Until the internet-based reporting system is developed and available, notify the department using established procedures. The notice must include:

(a) The hospital's name;

(b) The type of event identified in subsection (1) of this section;

(c) The date the event was confirmed; and

(d) Any additional contextual information the hospital chooses to provide;

(3) Conduct a root cause analysis of each adverse event following the procedures and methods of:

(a) The joint commission;

(b) The department of Veterans Affairs National Center for Patient Safety; or

(c) Another nationally recognized root cause analysis methodology found acceptable by the department;

(4) As part of the root cause analysis, include the following information in the report submitted to the contract entity referenced in RCW 70.56.040:

(a) The number of patients, registered nurses, licensed practical nurses, and unlicensed assistive personnel present in the relevant patient care unit at the time the reported adverse event occurred;

(b) The number of nursing personnel present at the time of the adverse event who have been supplied by temporary staffing agencies, including traveling nurses; and

(c) The number of nursing personnel, if any, on the patient care unit working beyond their regularly scheduled number of hours or shifts at the time of the event and the number of consecutive hours worked by each such nursing personnel at the time of the adverse event;

(5) Create and implement a corrective action plan for each adverse event consistent with the findings of the root cause analysis. Each corrective action plan must include:

(a) How each finding will be addressed and corrected;

(b) When each correction will be completed;

(c) Who is responsible to make the corrections;

(d) What action will be taken to prevent each finding from reoccurring; and

(e) A monitoring schedule for assessing the effectiveness of the corrective action plan including who is responsible for the monitoring schedule;

(6) If a hospital determines there is no need to create a corrective action plan for a particular adverse event, provide a written explanation of the reasons for not creating a corrective action plan;

(7) Complete and submit a root cause analysis within forty-five days, after confirming an adverse health event has occurred, to the department until the internet-based reporting system is developed and available.

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NEW SECTION
WAC 246-320-151   Reportable events.   The purpose of this section is to outline each hospital's responsibility for reporting serious events that affect the operation and maintenance of the facility.

(1) Hospitals must notify the department within forty-eight hours whenever any of the following events have occurred:

(a) A failure or facility system malfunction such as the heating, ventilation, fire alarm, fire sprinkler, electrical, electronic information management, or water supply affecting patient diagnosis, treatment, or care within the facility; or

(b) A fire affecting patient diagnosis, treatment, or care within the facility.

(2) Each notice to the department must include:

(a) The hospital's name;

(b) The event type from subsection (1) of this section; and

(c) The date the event occurred.

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NEW SECTION
WAC 246-320-156   Management of human resources.   This section ensures that hospitals provide competent staff consistent with scope of services.

Hospitals must:

(1) Establish, review, and update written job descriptions for each job classification;

(2) Conduct periodic staff performance reviews;

(3) Assure qualified staff available to operate each department including a process for competency, skill assessment and development;

(4) Assure supervision of staff;

(5) Document verification of staff licensure, certification, or registration;

(6) Complete tuberculosis screening for new and current employees consistent with the Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Healthcare Facilities, 2005. Morbidity Mortality Weekly Report (MMWR) Volume 54, December 30, 2005;

(7) Orient staff to their assigned work environment;

(8) Give infection control information to staff upon hire and annually which includes:

(a) Education on general infection control according to chapter 296-823 WAC bloodborne pathogens exposure control;

(b) Education specific to infection control for multidrug-resistant organisms; and

(c) General and specific infection control measures related to the patient care areas where staff work;

(9) Establish and implement an education plan that verifies or arranges for the training of staff on prevention, transmission, and treatment of human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) consistent with RCW 70.24.310.

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NEW SECTION
WAC 246-320-161   Medical staff.   The purpose of this section is to establish the development of a medical staff structure, consistent with clinical competence, to ensure a safe patient care environment.

The medical staff must:

(1) Adopt bylaws, rules, regulations, and organizational structure that address:

(a) Qualifications for membership;

(b) Verification of application data;

(c) Appointment and reappointment process;

(d) Length of appointment and reappointment;

(e) Granting of delineated clinical privileges;

(f) Provision for continuous patient care;

(g) Assessment of credentialed practitioner's performance;

(h) Due process;

(i) Reporting practitioners according to RCW 70.41.210; and

(j) Provide for medical staff communication and conflict resolution with the governing authority;

(2) Forward medical staff recommendations for membership and clinical privileges to the governing authority for action.

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NEW SECTION
WAC 246-320-166   Management of information.   The purpose of this section is to improve patient outcomes and hospital performance through obtaining, managing, and using information.

Hospitals must:

(1) Provide medical staff, employees and other authorized persons with access to patient information systems, resources, and services;

(2) Maintain confidentiality, security, and integrity of information;

(3) Initiate and maintain a medical record for every patient assessed or treated including a process to review records for completeness, accuracy, and timeliness;

(4) Create medical records that:

(a) Identify the patient;

(b) Have clinical data to support the diagnosis, course and results of treatment for the patient;

(c) Have signed consent documents;

(d) Promote continuity of care;

(e) Have accurately written, signed, dated, and timed entries;

(f) Indicate authentication after the record is transcribed;

(g) Are promptly filed, accessible, and retained according to RCW 70.41.190 and chapter 5.46 RCW; and

(h) Include verbal orders that are accepted and transcribed by qualified personnel;

(5) Establish a systematic method for identifying each medical record, identification of service area, filing, and retrieval of all patient's records; and

(6) Adopt and implement policies and procedures that address:

(a) Who has access to and release of confidential medical records according to chapter 70.02 RCW;

(b) Retention and preservation of medical records according to RCW 70.41.190;

(c) Transmittal of medical data to ensure continuity of care; and

(d) Exclusion of clinical evidence from the medical record.

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NEW SECTION
WAC 246-320-171   Improving organizational performance.   The purpose of this section is to ensure that performance improvement activities of staff, medical staff, and outside contractors result in continuous improvement of patient health outcomes. In this section "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.

Hospitals must:

(1) Have a hospital-wide approach to process design and performance measurement, assessment, and improving patient care services according to RCW 70.41.200 and include, but not be limited to:

(a) A written performance improvement plan that is periodically evaluated;

(b) Performance improvement activities which are interdisciplinary and include at least one member of the governing authority;

(c) Prioritize performance improvement activities;

(d) Implement and monitor actions taken to improve performance;

(e) Education programs dealing with performance improvement, patient safety, medication errors, injury prevention; and

(f) Review serious or unanticipated patient outcomes in a timely manner;

(2) Systematically collect, measure and assess data on processes and outcomes related to patient care and organization functions;

(3) Collect, measure and assess data including, but not limited to:

(a) Operative, other invasive, and noninvasive procedures that place patients at risk;

(b) Infection rates, pathogen distributions and antimicrobial susceptibility profiles;

(c) Death;

(d) Medication use;

(e) Medication management or administration related to wrong medication, wrong dose, wrong time, near misses and any other medication errors and incidents;

(f) Injuries, falls; restraint use; negative health outcomes and incidents injurious to patients in the hospital;

(g) Adverse events listed in WAC 246-320-146;

(h) Discrepancies or patterns between preoperative and postoperative (including pathologic) diagnosis, including pathologic review of specimens removed during surgical or invasive procedures;

(i) Adverse drug reactions (as defined by the hospital);

(j) Confirmed transfusion reactions;

(k) Patient grievances, needs, expectations, and satisfaction; and

(l) Quality control and risk management activities.

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NEW SECTION
WAC 246-320-176   Infection control program.   The purpose of this section is to identify and reduce the risk of acquiring and transmitting infections and communicable diseases between patients, employees, medical staff, volunteers, and visitors.

Hospitals must:

(1) Develop, implement and maintain a written infection control and surveillance program;

(2) Designate staff to:

(a) Manage the activities of the infection control program;

(b) Assure the infection control program conforms with patient care and safety policies and procedures; and

(c) Provide consultation on the infection control program, policies and procedures throughout the entire facility;

(3) Ensure staff managing the infection control program have:

(a) A minimum of two years experience in a health related field; and

(b) Training in the principles and practices of infection control;

(4) Develop and implement infection control policies and procedures consistent with the guidelines of the Centers for Disease Control and Prevention (CDC) and other nationally recognized professional bodies or organizations;

(5) Assure the infection control policies and procedures address, but are not limited to the following:

(a) Routine surveillance, outbreak investigations and interventions including pathogen distributions and antimicrobial susceptibility profiles consistent with the 2006 CDC Healthcare Infection Control Practices Advisory Committee Guideline, Management of Multidrug-Resistant Organisms in Healthcare Settings;

(b) Patient care practices in all clinical care areas;

(c) Receipt, use, disposal, processing, or reuse of equipment to prevent disease transmission;

(d) Preventing cross contamination of soiled and clean items during sorting, processing, transporting, and storage;

(e) Environmental management and housekeeping functions;

(f) Approving and properly using disinfectants, equipment, and sanitation procedures;

(g) Cleaning areas used for surgical procedures before, between, and after use;

(h) Hospital-wide daily and periodic cleaning;

(i) Occupational health consistent with current practice;

(j) Attire;

(k) Traffic patterns;

(l) Antisepsis;

(m) Handwashing;

(n) Scrub technique and surgical preparation;

(o) Biohazardous waste management according to applicable federal, state, and local regulations;

(p) Barrier and transmission precautions; and

(q) Pharmacy and therapeutics;

(6) Establish and implement a plan for:

(a) Reporting communicable diseases according to chapter 246-100 WAC; and

(b) Surveying and investigating communicable disease occurrences in the hospital consistent with WAC 246-320-XXX;

(7) Hospitals may develop and implement infection control policies and procedures specific to a patient care area.

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NEW SECTION
WAC 246-320-199   Fees.   This section establishes the license and annual use fees for hospitals.

(1) Applicants must:

(a) Send the department an initial license fee of one hundred thirteen dollars for each bed space within the authorized bed capacity for the hospital;

(b) Include all bed spaces in rooms complying with physical plant and movable equipment requirements of this chapter for twenty-four-hour assigned patient care;

(c) Include level 2 and 3 bassinet spaces;

(d) Include bed spaces assigned for less than twenty-four-hour patient use as part of the licensed bed capacity when:

(i) Physical plant requirements of this chapter are met without movable equipment; and

(ii) The hospital currently possesses the required movable equipment and certifies this fact to the department;

(e) Exclude all normal infant bassinets.

(2) Licensees shall:

(a) Send the department by November 30 of each year an annual use fee of one hundred thirteen dollars for each bed space within the authorized bed capacity of the hospital;

(b) Include all bed spaces in rooms complying with physical plant and movable equipment requirements of this chapter for twenty-four-hour assigned patient rooms;

(c) Include level 2 and 3 bassinet spaces;

(d) Include bed spaces assigned for less than twenty-four-hour patient use as part of the licensed bed capacity when:

(i) Physical plant requirements of this chapter are met without movable equipment; and

(ii) The hospital currently possesses the required movable equipment and certifies this fact to the department;

(e) Exclude all normal infant bassinets; and

(f) Exclude beds banked as authorized by certificate of need under chapter 70.38 RCW.

(3) A licensee shall send a late fee in the amount of one hundred dollars per day whenever the annual use fee is not paid by November 30. The total late fee will not exceed twelve hundred dollars.

(4) An applicant may request a refund for initial licensure as follows:

(a) Two-thirds of the initial fee paid after the department has received an application and not conducted an on-site survey or provided technical assistance; or

(b) One-third of the initial fee paid after the department has received an application and conducted either an on-site survey or provided technical assistance but not issued a license.

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PATIENT CARE
NEW SECTION
WAC 246-320-201   Food and nutrition services.   The purpose of this section is to assure patient nutritional needs are met in a planned and organized manner.

Hospitals must:

(1) Designate an individual qualified by experience, education, or training to be responsible for managing the food and nutrition services;

(2) Designate a registered dietitian responsible to develop and implement policies and procedures addressing nutritional care for patients;

(3) Have a registered dietitian available to assess nutritional needs, based on patients' individual nutritional risk screen;

(4) Develop and regularly update an interdisciplinary plan for nutritional therapy based on current standards for patients at nutritional risk. Monitor and document each patient's response to the nutritional therapy in the medical record;

(5) Implement, document and monitor a system for providing nutritionally balanced meals that are planned in advance, and respect cultural diversity; and

(6) Adopt and implement policies and procedures for food service according to chapter 246-215 WAC.

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NEW SECTION
WAC 246-320-206   Linen and laundry services.   The purpose of this section is to prevent the use of dirty or contaminated laundry or linens.

Hospitals must develop and implement a laundry and linen system that:

(1) Meets the needs of the hospital and patients;

(2) Assures linens and laundry are clean and free from contaminants and toxic residues;

(3) Processes within industry standard pH ranges; and

(4) Processes and stores according to the Guidelines for Design and Construction of Health Care Facilities, 2.1-6.4.

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NEW SECTION
WAC 246-320-211   Pharmaceutical services.   This section assures patient pharmaceutical needs are met in a planned and organized manner.

Hospitals must:

(1) Meet the requirements in chapter 246-873 WAC; and

(2) Establish and use a process for selecting medications based on evaluating their relative therapeutic merits, safety, and cost.

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NEW SECTION
WAC 246-320-216   Laboratory, imaging, and other diagnostic, treatment or therapeutic services.   The purpose of this section is to assure patients' diagnostic, treatment or therapy services are met in a planned and organized manner.

Hospitals must adopt and implement policies and procedures that:

(1) Require pathology and clinical laboratory services on a timely basis;

(2) Assure the laboratory services meet the requirements in chapter 246-338 WAC;

(3) Assure imaging services are directed by an individual qualified by experience, education, or training and meet the requirements in chapter 246-220 WAC.

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NEW SECTION
WAC 246-320-221   Safe patient handling.   RCW 70.41.390 mandates hospitals establish and implement a safe patient handling program. The purpose of this section is to guide hospital management in developing and implementing that program.

The hospital must:

(1) Develop and implement a safe patient handling policy that includes:

(a) A patient handling hazard assessment;

(b) An annual performance evaluation of the program;

(c) Procedures for hospital staff to follow who refuse to perform or be involved in patient handling or movement based upon exposing the staff or patient to an unacceptable risk of injury; and

(d) The types of equipment and devices used as part of the program;

(2) Conduct annual staff training on all safe patient handling policies, procedures, equipment and devices; and

(3) Not discipline a hospital employee who in good faith follows the procedure for refusing to perform or be involved in the patient handling.

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NEW SECTION
WAC 246-320-226   Patient care services.   This section guides the development of a plan for patient care. This is accomplished by supervising staff, establishing, monitoring, and enforcing policies and procedures that define and outline the use of materials, resources, and promote the delivery of care.

Hospitals must:

(1) Provide personnel, space, equipment, reference materials, training, and supplies for the appropriate care and treatment of patients;

(2) Have a registered nurse available for consultation in the hospital at all times;

(3) Adopt, implement, review and revise patient care policies and procedures designed to guide staff that address:

(a) Criteria for patient admission to general and specialized service areas;

(b) Reliable method for personal identification of each patient;

(c) Conditions that require patient transfer within the facility, to specialized care areas and outside facilities;

(d) Patient safety measures;

(e) Staff access to patient care areas;

(f) Use of physical and chemical restraints or seclusion consistent with CFR 42.482;

(g) Use of preestablished patient care guidelines or protocols. When used, these must be documented in the medical record and be preapproved or authenticated by an authorized practitioner;

(h) Care and handling of patients whose condition require special medical or medical-legal consideration;

(i) Preparation and administration of blood and blood products; and

(j) Discharge planning;

(4) Have a system to plan and document care in an interdisciplinary manner, including:

(a) Development of an individualized patient plan of care, based on an initial assessment;

(b) Periodic review and revision of individualized plan of care based on patient reassessment; and

(c) Periodic assessment for risk of falls, skin condition, pressure ulcers, pain, medication use, therapeutic effects and side or adverse effects;

(5) Complete and document an initial assessment of each patient's physical condition, emotional, and social needs in the medical record. Initial assessment includes:

(a) Patient history and physical assessment including but not limited to falls, mental status and skin condition;

(b) Current needs;

(c) Need for discharge planning;

(d) Immunization status for pediatric patients;

(e) Physical examination, if within thirty days prior to admission, and updated as needed if patient status has changed;

(f) Ongoing specialized assessments depending on the patient's condition or needs, including:

(i) Nutritional status;

(ii) Functional status; and

(iii) Social, psychological, and physiological status;

(g) Reassessments according to plan of care and patient's condition; and

(h) Discharge plans when appropriate, coordinated with:

(i) Patient, family or caregiver; and

(ii) Receiving agency, when necessary.

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NEW SECTION
WAC 246-320-231   Patient care unit or area.   The purpose of this section is to guide the management of a patient area.

Hospitals must assure:

(1) Each patient room contains:

(a) A bed;

(b) Patient privacy; and

(c) A means to call for help or assistance;

(2) Each patient care unit has:

(a) A means for staff to clean their hands before giving care to a patient;

(b) Staff available at all times to provide care to patients; and

(c) A means for staff to record and maintain individual patient records;

(3) Staff respond to calls for help or assistance.

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NEW SECTION
WAC 246-320-236   Surgical services.   The purpose of this section is to guide the development and management of surgical services. Hospitals are not required to provide surgery and interventional care in order to be licensed.

If providing surgical services, hospitals must:

(1) Adopt and implement policies and procedures that:

(a) Identify areas where surgery and invasive procedures may be performed;

(b) Define staff access to areas where surgery and invasive procedures are performed;

(c) Identify practitioner's privileges for operating room staff; and

(d) Define staff qualifications and oversight;

(2) Use hospital policies and procedures which define standards of care;

(3) Implement a system to identify and indicate the correct surgical site prior to beginning a surgical procedure;

(4) Timely provide emergency equipment, supplies, and services to surgical and invasive areas;

(5) Provide separate refrigerated storage equipment with temperature alarms, when blood is stored in the surgical department; and

(6) Assure that a registered nurse qualified by training and experience functions as the circulating nurse in every operating room during surgical procedures.

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NEW SECTION
WAC 246-320-241   Anesthesia services.   The purpose of this section is to guide the management and care of patients receiving anesthesia. Hospitals are not required to provide anesthesia services in order to be licensed.

If providing anesthesia services, hospitals must:

(1) Adopt and implement policies and procedures that:

(a) Identify the types of anesthesia that may be used;

(b) Identify areas where each type of anesthesia may be used; and

(c) Define the staff qualifications and oversight for administering each type of anesthesia used in the hospital;

(2) Use hospital policies and procedures which define standards of care;

(3) Assure emergency equipment, supplies and services are immediately available in all areas where anesthesia is used.

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NEW SECTION
WAC 246-320-246   Recovery care.   The purpose of this section is to guide the management of patients recovering from anesthesia and sedation. Hospitals are not required to provide anesthesia recovery services in order to be licensed.

If providing recovery services, hospitals must:

(1) Adopt and implement policies and procedures that define the qualifications and oversight of staff delivering recovery services;

(2) Assure a physician or licensed independent practitioner capable of managing complications and providing cardiopulmonary resuscitation is immediately available for patients recovering from anesthesia; and

(3) Assure a registered nurse trained and current in advanced cardiac life support measures is immediately available for patients recovering from anesthesia.

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NEW SECTION
WAC 246-320-251   Obstetrical services.   The purpose of this section is to guide the management and care of patients receiving obstetrical care services. Hospitals are not required to provide obstetrical services in order to be licensed.

If providing obstetrical services hospitals must:

(1) Have the capability to perform cesarean sections twenty-four hours per day, or meet the following criteria when the hospital does not have twenty-four hour cesarean capability:

(a) Limit planned obstetrical admissions to "low risk" patients as defined in WAC 246-329-010(18) childbirth centers;

(b) Inform each obstetrical patient in writing, prior to the planned admission, of the limited obstetrical services as well as transportation and transfer agreements;

(c) Maintain current written agreements for staffed ambulance or air transport available twenty-four hours per day; and

(d) Maintain current written agreements with another hospital to admit transferred obstetrical patients;

(2) Define qualifications and oversight of staff delivering obstetrical care;

(3) Use hospital policies and procedures which define standards of care; and

(4) Ensure one registered nurse trained in neonatal resuscitation is in the hospital when infants are present.

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NEW SECTION
WAC 246-320-256   Neonatal and pediatric services.   The purpose of this section is to guide the management and care of patients receiving neonatal or pediatric care services. Hospitals are not required to provide these services in order to be licensed.

If providing neonatal or pediatric care, hospitals must:

(1) Adopt and implement policies and procedures that:

(a) Identify the types of patients and level of care that may be used; and

(b) Define the qualifications and oversight of staff delivering neonatal or pediatric services;

(2) Use hospital policies and procedures which define standards of care;

(3) Assure one registered nurse or physician trained in infant and pediatric resuscitation is present in the hospital when infants or pediatric patients are receiving care;

(4) Assure laboratory, pharmacy, radiology, and respiratory care services appropriate for neonates, infants and pediatric patients are:

(a) Provided in a timely manner; and

(b) Available in the hospital at all times during assisted ventilation;

(5) When providing a level 2 or level 3 nursery service assure:

(a) Laboratory, pharmacy, radiology, and respiratory care services appropriate for neonates are available in the hospital at all times;

(b) An anesthesia practitioner, neonatologist, and a pharmacist available twenty-four hours a day; and

(c) One registered nurse or physician trained in neonate resuscitation is present in the hospital when a neonate is receiving care.

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NEW SECTION
WAC 246-320-261   Critical or intensive care services.   The purpose of this section is to guide the management and care of patients receiving critical or intensive care services. Hospitals are not required to provide these services in order to be licensed.

If providing a critical care unit or services, hospitals must:

(1) Define the qualifications and oversight of staff delivering critical or intensive care services;

(2) Assure at least two licensed nurses skilled and trained in critical care, on duty and in the hospital at all times, when patients are present, and:

(a) Immediately available to provide care to admitted patients; and

(b) All registered nurses trained and current in cardiopulmonary resuscitation with:

(i) Training for the safe and effective use of specialized equipment and procedures in the particular area; and

(ii) At least one registered nurse having successfully completed an advanced cardiac life support training program;

(3) Assure laboratory, radiology, and respiratory care services available in a timely manner; and

(4) Use hospital policies and procedures which define standards of care.

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NEW SECTION
WAC 246-320-266   Alcohol and chemical dependency services.   The purpose of this section is to guide the management and care of patients receiving alcohol and chemical dependency services. Hospitals are not required to provide these services in order to be licensed.

If providing alcoholism or chemical dependency services hospitals must:

(1) Adopt and implement policies and procedures on the development, use, and review of the individualized treatment plan, including participation by:

(a) Multidisciplinary treatment team;

(b) Patient; and

(c) Family as appropriate;

(2) Define the qualifications and oversight of staff delivering alcohol and chemical dependency care services;

(3) Use hospital policies and procedures which define standards of practice;

(4) Assure patient privacy during interviewing, group and individual counseling, physical examinations, and social activities; and

(5) Provide services according to WAC 246-324-170.

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NEW SECTION
WAC 246-320-271   Psychiatric services.   The purpose of this section is to guide the management and care of patients receiving psychiatric services. Hospitals are not required to provide these services in order to be licensed.

If providing a psychiatric services, hospitals must:

(1) Adopt and implement policies and procedures on the development, use, and review of the individualized treatment plan, including participation by:

(a) Multidisciplinary treatment team;

(b) Patient; and

(c) Family as appropriate;

(2) Define the qualifications and oversight of staff delivering psychiatric services;

(3) Use hospital policies and procedures which define standards of practice;

(4) Assure patient privacy during interviewing, group and individual counseling, physical examinations, and social activities;

(5) Provide services according to WAC 246-322-170;

(6) Designate and use separate sleeping rooms for children and adults;

(7) Provide or have access to at least one seclusion room; and

(8) Assure close observation of patients.

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NEW SECTION
WAC 246-320-276   Long-term care services.   The purpose of this section is to guide the management and care of patients receiving long-term care services. Hospitals are not required to provide these services in order to be licensed.

If providing long-term care services, hospitals must:

(1) Define the qualifications and oversight of staff delivering long-term care services;

(2) Develop and implement policies and procedures specific to the care and needs of patients receiving the long-term services;

(3) Use hospital policies and procedures which define standards of practice; and

(4) Provide an activities program designed to encourage each patient to maintain or attain normal activity and an optimal level of independence.

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NEW SECTION
WAC 246-320-281   Emergency services.   The purpose of this section is to guide the management and care of patients receiving emergency services. Hospitals are not required to provide these services in order to be licensed.

If providing emergency services, hospitals must:

(1) Adopt and implement policies and procedures, consistent with RCW 70.170.060, for every patient presenting to the emergency department with an emergency medical condition to include:

Transfer of a patient with an emergency medical condition or who is in active labor based on:

(a) Patient request;

(b) Inability to treat the patient due to facility capability;

(c) Staff availability or bed availability; and

(d) The ability of the receiving hospital to accept and care for the patient;

(2) Maintain the capacity to perform emergency triage and medical screening exam twenty-four hours per day;

(3) Define the qualifications and oversight of staff delivering emergency care services;

(4) Use hospital policies and procedures which define standards of care;

(5) Assure at least one registered nurse skilled and trained in emergency care services on duty and in the hospital at all times, who is:

(a) Immediately available to provide care; and

(b) Trained and current in advanced cardiac life support;

(6) Post names and telephone numbers of medical and other staff on call;

(7) Assure communication with agencies and health care providers as indicated by patient condition; and

(8) Assure emergency equipment, supplies and services necessary to meet the needs of presenting patients are immediately available.

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NEW SECTION
WAC 246-320-286   Emergency contraception.   The purpose of this section is to ensure that all hospitals with emergency rooms provide emergency contraception as a treatment option to any woman who seeks treatment as a result of a sexual assault.

Every hospital that provides emergency care must:

(1) Develop and implement policies and procedures regarding the provision of twenty-four-hour/seven-days per week emergency care to victims of sexual assault;

(2) Provide the victim of sexual assault with medically and factually accurate and unbiased written and oral information about emergency contraception;

(3) Orally inform each victim in a language she understands of her option to be provided emergency contraception at the hospital; and

(4) Immediately provide emergency contraception, as defined in WAC 246-320-010, to each victim of sexual assault if the victim requests it, and if the emergency contraception is not medically contraindicated.

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NEW SECTION
WAC 246-320-291   Dialysis services.   The purpose of this section is to guide the management and care of patients receiving dialysis services. Hospitals are not required to provide these services in order to be licensed.

If providing renal dialysis care, hospitals must:

(1) Adopt and implement policies and procedures consistent with CFR 42.405, End Stage Renal Disease Facilities for:

(a) Cleaning and sterilization procedures when dialyzers are reused;

(b) Water treatment, to ensure water quality; and

(c) Bacterial contamination and chemical purity water testing;

(2) Test each dialysis machine for bacterial contamination monthly or demonstrate a program establishing the effectiveness of disinfection methods at other intervals;

(3) Take measures to prevent contamination, including backflow prevention in accordance with the state plumbing code;

(4) Keep available any special dialyzing solutions required by a patient;

(5) Define the qualifications and oversight of staff delivering dialysis care;

(6) Require a contractor to meet the requirements in this section, whenever dialysis service is provided through a contract.

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NEW SECTION
WAC 246-320-296   Management of environment for care.   The purpose of this section is to manage environmental hazards and risks, prevent accidents and injuries, and maintain safe conditions for patients, visitors, and staff.

(1) Hospitals must have an environment of care management plan that addresses safety, security, hazardous materials and waste, emergency preparedness, fire safety, medical equipment, utility systems and physical environment.

(2) The hospital must designate a person responsible to develop, implement, monitor, and follow-up on all aspects of the management plan.

(3) Safety. The hospital must establish and implement a plan to:

(a) Maintain a physical environment free of hazards;

(b) Reduce the risk of injury to patients, staff, and visitors;

(c) Investigate and report safety related incidents;

(d) Correct or take steps to avoid reoccurrence of the incidents in the future;

(e) Develop and implement policies and procedures on safety related issues such as but not limited to physical hazards and injury prevention; and

(f) Educate and periodically review with staff, policies and procedures relating to safety and job-related hazards.

(4) Security. The hospital must:

(a) Establish and implement a plan to maintain a secure environment for patients, visitors, and staff, to include preventing abduction of patients;

(b) Educate staff on security procedures; and

(c) Train security staff to a level of skill and competency for their assigned responsibility.

(5) Hazardous materials and waste. The hospital must:

(a) Establish and implement a program to safely control hazardous materials and waste according to federal, state, and local regulations;

(b) Provide space and equipment for safe handling and storage of hazardous materials and waste;

(c) Investigate all hazardous material or waste spills, exposures, and other incidents, and report as required to appropriate authority; and

(d) Educate staff on policies and procedures relating to safe handling and control of hazardous materials and waste.

(6) Emergency preparedness. The hospital must:

(a) Establish and implement a disaster plan designed to address both internal and external disasters. The plan must be:

(i) Specific to the hospital;

(ii) Relevant to the geographic area;

(iii) Readily put into action, twenty-four hours a day, seven days a week; and

(iv) Reviewed and revised periodically;

(b) Ensure the disaster plan identifies:

(i) Who is responsible for each aspect of the plan; and

(ii) Essential and key personnel responding to a disaster;

(c) Include in the plan:

(i) A staff education and training component;

(ii) A process for testing each aspect of the plan; and

(iii) A component for debriefing and evaluation after each disaster, incident or drill.

(7) Fire safety. The hospital must:

(a) Establish and implement a plan to maintain a fire-safe environment that meets fire protection requirements established by the Washington state patrol, fire protection bureau;

(b) Investigate fire protection deficiencies, failures, and user errors; and

(c) Orient, educate, and conduct drills with staff on policies and procedures relating to fire prevention and emergencies.

(8) Medical equipment. The hospital must establish and implement a plan to:

(a) Complete a technical and engineering review to verify medical equipment will function safely within building support systems;

(b) Inventory all patient equipment and related technologies that require preventive maintenance;

(c) Perform and document preventive maintenance;

(d) Develop and implement a quality control program;

(e) Assure consistent service of equipment, independent of service vendors or methodology;

(f) Investigate, report, and evaluate procedures in response to equipment failures; and

(g) Educate staff on the proper and safe use of medical equipment.

(9) Utility systems. The hospital must establish and implement policies, procedures and a plan to:

(a) Maintain a safe and comfortable environment;

(b) Assess and minimize risks of utility system failures;

(c) Ensure operational reliability of utility systems;

(d) Investigate and evaluate utility systems problems, failures, or user errors and report incidents and corrective actions;

(e) Perform and document preventive maintenance; and

(f) Educate staff on utility management policies and procedures.

(10) Physical environment. The hospital must provide:

(a) Storage;

(b) Plumbing with:

(i) A water supply providing hot and cold water under pressure which conforms to chapter 246-290 WAC;

(ii) Hot water supplied for bathing and handwashing not exceeding 120F;

(iii) Cross connection controls meeting requirements of the state plumbing code;

(c) Ventilation to:

(i) Prevent objectionable odors and/or excessive condensation; and

(ii) With air pressure relationships as designed and approved by the department when constructed and maintained within industry standard tolerances;

(d) Clean interior surfaces and finishes; and

(e) Functional patient call system.

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REPEALER

     The following sections of the Washington Administrative Code are repealed:
WAC 246-320-025 On-site licensing survey.
WAC 246-320-045 Application for license -- License expiration dates -- Notice of decision -- Adjudicative proceeding.
WAC 246-320-065 Exemptions, alternative methods, and interpretations.
WAC 246-320-085 Single license to cover two or more buildings--When permissible.
WAC 246-320-105 Criminal history, disclosure, and background inquiries.
WAC 246-320-125 Governance.
WAC 246-320-145 Leadership.
WAC 246-320-165 Management of human resources.
WAC 246-320-185 Medical staff.
WAC 246-320-205 Management of information.
WAC 246-320-225 Improving organizational performance.
WAC 246-320-245 Patient rights and organizational ethics.
WAC 246-320-265 Infection control program.
WAC 246-320-285 Pharmacy services.
WAC 246-320-305 Food and nutrition services.
WAC 246-320-325 Laboratory, imaging, and other diagnostic, treatment or therapeutic services.
WAC 246-320-345 Inpatient care services.
WAC 246-320-365 Specialized patient care services.
WAC 246-320-370 Emergency contraception.
WAC 246-320-385 Outpatient care services.
WAC 246-320-405 Management of environment for care.
WAC 246-320-615 Pharmacy.
WAC 246-320-990 Fees.

Washington State Code Reviser's Office