WAC 246-329-045   Applicant or licensee rights and responsibilities.  This section describes the applicant or licensee's responsibilities in the fulfillment of the requirements of this chapter.

     (1) An applicant or licensee must:

     (a) Comply with chapter 18.46 RCW and this chapter;

     (b) Establish, implement and periodically review all policies and procedures which address the contents of this chapter;

     (c) Display the license issued by the department in an area accessible to the public;

     (d) Notify the department in writing:

     (i) Within thirty days of changes of an administrator, owner or the director of clinical services;

     (ii) Thirty or more days before ceasing operations;

     (e) Cooperate with the department during surveys which may include reviewing licensee and client records and conducting client interviews with client consent;

     (f) Respond to a statement of deficiencies by submitting to the department:

     (i) A written plan of correction, within ten working days of receipt. The applicant or licensee must complete all corrections within sixty days after the survey exit date, unless otherwise specified by the department; and

     (ii) A progress report describing corrections made and ongoing monitoring actions, within ninety days after the survey exit date, unless the department specifies another date.

     (2) An applicant or licensee may:

     (a) Discuss findings observed during a survey with the surveyor; and

     (b) Discuss the statement of deficiencies with the department's manager.

     (3) As required by chapter 70.56 RCW, the licensed childbirth center shall notify the department if any of the following events have been confirmed to have occurred in the birth center:

     (a) An infant abduction or discharge to the wrong family;

     (b) Sexual assault or rape of a patient or staff member while in the birth center;

     (c) Maternal death or serious disability with labor or delivery in a low-risk pregnancy while being cared for in a health care facility;

     (d) Patient death or serious disability associated with:

     (i) The use of contaminated drugs, devices, or biologics provided by the health care facility;

     (ii) The use or function of a device in which the device is used or functions other than as intended;

     (iii) Intravascular air embolism that occurs while being cared for in a health care facility;

     (iv) A medication error (errors involving wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation or wrong route of administration);

     (v) Hypoglycemia, the onset of which occurs while the patient is being cared for in a health care facility;

     (vi) Failure to identify and treat hyperbilirubinimia in neonates;

     (vii) An electric shock while being cared for in a health care facility; or

     (viii) A burn incurred from any source while being cared for in a health care facility.

     (e) Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by toxic substances;

     (f) Patient suicide, or attempted suicide resulting in serious disability, that occurs while the patient is receiving care in a health care facility;

     (g) Death or significant injury of a patient or staff member resulting from physical assault that occurs within or on the grounds of a health care facility;

     (h) Any instance of care ordered by someone impersonating a physician, nurse, pharmacist or other licensed health care provider;

     (i) Patient death associated with a fall while being cared for in a health care facility;

     (j) Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health care facility; and

     (k) Sexual assault on a patient within or on the grounds of a health care facility.

     (4) The licensed childbirth center must also notify the department if either of the following events have been confirmed to have occurred in the birth center:

     (a) An unanticipated death, stillbirth or major loss of function; or

     (b) Any catastrophic incident, such as fire or flood, or any incident which may cause interruption or cessation of the delivery of services, or another interruption of services which would affect the health and safety of the client.

     (5) The report required in subsection (3) and (4) of this section must be submitted in writing to the department as required by chapter 70.56 RCW. The birth center is encouraged to confirm these events through a review or assessment by the birth center's quality improvement or risk management process. Each notice to the department must include:

     (a) The licensee's name;

     (b) The name of the affected client, if applicable;

     (c) The date the event occurred;

     (d) A description of the event and a clinical summary if the event is client-related;

     (e) Root cause analysis and corrective action plans as required by chapter 70.56 RCW.

     (6) The report note in subsection (3) of this section:

     (a) Will allow the department to be informed of events which in the interest of the public will be reviewed and reported as required by chapter 70.56 RCW;

     (b) Will be confidentially maintained by the department in accordance with the protections of the Public Disclosure Act, chapter 42.17 RCW, and other applicable laws and reporting requirements; and

     (c) Does not relieve a birth center from complying with other applicable reporting or notification requirements of this chapter or those requirements relating to law enforcement or professional regulatory agencies.

     (7) An applicant or licensee has the right to respond to and contest a statement of charges according to the following provisions:

     (a) RCW 43.70.115, department of health authority for license approval, denial, restriction, conditioning, modification, suspension and revocation;

     (b) Chapter 34.05 RCW, the Administrative Procedure Act; and

     (c) Chapter 246-10 WAC, Adjudicative proceedings.



[Statutory Authority: Chapter 18.46 RCW and RCW 43.70.040. 07-07-075, § 246-329-045, filed 3/16/07, effective 4/16/07.]