WSR 08-22-090

PROPOSED RULES

DEPARTMENT OF HEALTH


[ Filed November 4, 2008, 4:49 p.m. ]

Supplemental Notice to WSR 08-14-143.

Preproposal statement of inquiry was filed as WSR 08-08-088.

Title of Rule and Other Identifying Information: Chapter 246-322 WAC, Private psychiatric and alcoholism hospitals, supplemental notice creating new section WAC 246-322-260 for adverse health event and incident reporting system.

Hearing Location(s): Department of Health, Point Plaza East, Room 139, 310 Israel Road S.E., Tumwater, WA 98501, on January 12, 2009, at 9:30 a.m.

Date of Intended Adoption: February 12, 2009.

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 January 12, 2009.

Assistance for Persons with Disabilities: Contact John Hilger by January 9, 2009, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: In 2006 the legislature passed 2SHB 2292 codified as chapter 70.56 RCW establishing the adverse health event and incident reporting system for "medical facilities." For the purposes of adverse event reporting, psychiatric hospitals are defined as a medical facility. The proposed rules include a list of reportable adverse events, how and when to report adverse events, the form and content of the root cause analysis and the corrective action plan. In 2008 the legislature passed SB 6457 allowing hospitals to include any contextual information about an adverse event, added a timeline for reporting confirmed events and the subsequent report within forty-five days. Also in 2008, E2SHB 3123 was passed which added elements related to staffing levels at the time an event occurred. This supplemental notice amends the original proposal to include the requirements from the 2008 legislation. The intent is to improve patient safety.

Reasons Supporting Proposal: 2SHB 2292 (chapter 70.56 RCW) requires the department to adopt in rule updates to the list of serious reportable events adopted by the national quality forums in 2002. Establishing the 2002 list in rule provides for a basis for future amendments. In addition, 2SHB 2292 requires the form and content of the root cause analysis and corrective action plan, which are required in the event of the occurrence of adverse events, to be adopted into rule. In addition, the 2008 legislation requires the rules to be amended so that they are in compliance with the statute.

Statutory Authority for Adoption: Chapter 70.56 RCW.

Statute Being Implemented: Chapter 70.56 RCW.

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

Name of Proponent: Department of health, health professions and facilities, governmental.

Name of Agency Personnel Responsible for Drafting and Implementation: Byron Plan, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-2905; and Enforcement: Steve Saxe, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-2905.

No small business economic impact statement has been prepared under chapter 19.85 RCW. None of the facilities subject to this rule fall under the definition of a small business.

A cost-benefit analysis is not required under RCW 34.05.328. This proposal is exempt from this requirement under RCW 34.05.328 (5)(b)(v). The content of the rules are explicitly and specifically dictated by statute.

November 4, 2008

Mary C. Selecky

Secretary

OTS-1594.5


NEW SECTION
WAC 246-322-260   Adverse health events and incident reporting system.   The purpose of this section is to outline each psychiatric 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.

Psychiatric 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. Patient 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.
28. Artificial insemination with the wrong donor sperm or egg.

(2) Notify the department within forty-eight hours of confirmation by the psychiatric 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 psychiatric 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 psychiatric 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 report, 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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Washington State Code Reviser's Office