State of Wyoming

 

 

 

 

 

 

 

 

 

 

Department of Health

 

 

 

Rules and Regulations for

Healthcare Facility Safety Event Reporting

 

 

 

 

Brent D. Sherard, M.D., M.P.H., Director

 

 

 

 

 

October 2008

State of Wyoming

Department of Health

 

 

 

 

 

 

Rules and Regulations for

Healthcare Facility Safety Event Reporting

 

 

 

 

 

Rules and Regulations for

Healthcare Facility Safety Event Program

is published by the Department of Health

Brent D. Sherard, M.D., M.P.H., Director and State Health Officer

 

 

 

 

 

 

Additional information and copies may be obtained from:

Linda Chasson, Administrator

Preventive Health and Safety Division

6101 Yellowstone, Suite 510

Cheyenne, WY 82002

Phone:  (307) 777-7172

Fax:  (307) 777-5402

Email:  lchass@state.wy.us

 

 

 

 

 

 

This document is available in alternative format upon request.

 

Statement of Reasons

Healthcare Facility Safety Event Reporting

Chapter 2

 

            The Wyoming Department of Health proposes the following amended rules to comply with the provisions of the Healthcare Facility Safety Event Act, as amended in the 2008 General Session, House Enrolled Act No. 104 (codified at W.S. 35-2-912), and the Wyoming Administrative Procedures Act at W.S. 16-3-101, et seq., which authorizes the Department of Health to promulgate rules to establish the Healthcare Facility Safety Event Program.  The proposed amended rules address changes in the national Health and Human Services Agency for Healthcare Research and Quality standardized list of patient safety events. 

 

           

 

 

            Any act authorized or required herein is subject to confidentiality, immunity and whistle blowing provisions of W.S. 35-2-910(a) and (b).  Healthcare information may be disclosed to the department of health without the patient’s authorization, if pursuant to this act.

 

            As required by W.S. 16-3-103(a)(i)(G), the Healthcare Facility Safety Event reporting rule meets the minimum substantive state statutory requirements.

 

DEPARTMENT OF HEALTH

 

HEALTHCARE FACILITY SAFETY EVENT PROGRAM

 

 

CHAPTER 2

 

TABLE OF CONTENTS

 

 

Section No.

Subject

Page No.

 

 

 

1

Authority

2-1

2

Purpose and Applicability

2-1

3

General Provisions

2-1

4

Definitions

2-1

5

Safety Events to be Reported

2-3

6

Designation of Patient Safety Officers

2-5

7

Reporting Procedures for Healthcare Facility Safety Event

2-5

8

Statewide Annual Safety Event Report

2-6

9

Confidentiality, Immunity and Whistle Blowing

2-6

10

Disclosure without Patient’s Authorization

2-7

11

Interpretation of Chapter

2-7

12

Superseding Effect

2-7

13

Severability

2-7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chapter 2

Healthcare Facility Safety Event Program

 

Section 1.        Authority.

 

This Chapter is promulgated by the Department of Health pursuant to the provisions of the Healthcare Facility Safety Event Act, codified at W.S. 35-2-912, and the Wyoming Administrative Procedures Act at W.S. 16-3-101, et seq., which authorizes the Department of Health to promulgate rules to establish the Healthcare Facility Safety Event Program.

 

Section 2.        Purpose and Applicability.

 

(a)        These rules shall apply to and govern the Healthcare Facility Safety Event Program.  They shall become effective upon adoption for all healthcare facilities to report any safety event occurring after June 30, 2005.

 

(b)        The Department may issue manuals, bulletins, or both, to interpret the provisions of these rules and regulations.  Such manuals and bulletins shall be consistent with and reflect the policies contained in these rules and regulations.  The provisions contained in manuals or bulletins shall be subordinate to the provisions of these rules and regulations.

 

Section 3.        General Provisions. 

 

(a)        This Chapter is intended to be read in conjunction with the Healthcare Facility Safety Event Act, codified at W.S. 35-2-912.

 

(b)        The incorporation by reference of any external standard is intended to be the incorporation of that standard as it is in effect on the effective date of this Chapter of these rules and regulations.

 

Section 4.        Definitions. 

 

The following definitions shall apply in the interpretation and enforcement of these rules.  Where the context in which words are used in these rules indicates that such is the intent, words in the singular shall include the plural and vice versa.  Throughout these rules gender pronouns are used interchangeably, except where the context dictates otherwise.  The drafters have attempted to utilize each gender pronoun in equal numbers, in random distribution.  Words in each gender shall include individuals of the other gender.  Except as otherwise specified in this section, the terminology used in this Chapter is the standard terminology and has the standard meaning used in health care, health insurance, Medicare and Medicaid.

For the purpose of these rules, the following definitions shall apply:

 

(a)        "Act" means the Healthcare Facility Safety Event Act, codified at W.S. 35-2-912.

(b)        “Department” means the Wyoming Department of Health, Preventive Health and Safety Division, its agent, designee, or successor;

 

(c)               “Device” includes, but is not limited to, catheters, drains, and other specialized tubes, infusion pumps, and ventilators;

 

(d)        “Director” means the director of the Department, the director’s agent, designee, or successor;

 

(e)               “Documentation” means written evidence, in the form specified by the Department, to support an assertion or position;

 

(f)                 “Health care facility” means any licensed health care facility in the State of Wyoming;

 

(g)        “Hospital” means a health care facility where the sick or injured are given medical or surgical care;

 

(h)        “Hyperbilirubinemia” means billirubin levels greater than thirty (30) milligrams per deciliter;

 

(i)         “Patient” means an individual under medical care, treatment or medical

services;

 

(j)         “Patient safety officer” is an employee of a licensed health care facility

located within this state that is designated to receive and pass on reports of patient safety events to the department of health;

 

(k)        “Program” means the Health Care Facility Safety Event Program created by the Act and implemented by this Chapter;

 

(l)         “Public records” means “Public records” as defined in W.S. 16-4-201(a)(v), which is incorporated by this reference; and

 

            (m)      “Safety event” means an unexpected occurrence involving death or serious physical or psychological injury or the risk thereof, including:

 

(i)                 Surgical events;

(ii)               Product or device events;

(iii)             Patient protection events;

(iv)              Care management events;

(v)                Environmental events; and

(vi)              Criminal events.

 

            Section 5.        Safety Events to be Reported.

 

(a)        The following “safety” events or unexpected occurrences involving death or serious physical or psychological injury or the risk thereof are required to be reported to the Department of Health in the specified report format:

 

(i)                  Surgical events such as:

 

(A)               Surgery performed on a wrong body part that is not consistent with the documented informed consent for that patient.  Reportable events do not include situations requiring prompt action that occur in the course of surgery or situation whose urgency precludes obtaining informed consent;

 

(B)              Surgery performed on the wrong patient;

 

(C)              The wrong surgical procedure performed on a patient that is not consistent with the documented informed consent for that patient.  Reportable events do not include situations requiring prompt action that occur in the course of surgery or situations whose urgency precludes obtaining informed consent;

 

(D)       Retention of a foreign object in a patient after surgery or other procedure, excluding objects intentionally implanted as part of a planned intervention and objects prior to surgery that are intentionally retained; and

 

(E)       Death during or immediately after surgery of a normal, healthy patient who has no organic, physiologic, biochemical, or psychiatric disturbance, and for whom the pathologic processes for which the operation is to be performed are localized and do not entail a systemic disturbance.

 

(ii)                Product or device events resulting in patient death or serious disability associated with:

 

(A)       The use of contaminated drugs, devices or biologics provided by the facility when the contamination is the result of generally detectable contaminants in drugs, devices or biologics regardless of the source of the contamination or the product;

 

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

(C)       Intravascular air embolism that occurs while being cared for in a facility, excluding deaths associated with neurosurgical procedures known to present a high risk of intravascular air embolism.

 

(iii)               Patient protection events, including:

 

(A)              An infant discharged to the wrong person;

 

(B)              Patient death or serious disability associated with patient disappearance for more than four (4) hours, excluding events involving adults who have decision making capacity; and

 

(C)              Patient suicide or attempted suicide resulting in serious disability while being cared for in a facility due to patient actions after admission to this facility, excluding deaths resulting from self-inflicted injuries that were the reason for admission to the facility.

 

(iv)              Care management events, including:

 

(A)               Patient death or serious disability associated with a medication error including, but not limited to, errors involving the wrong drug, the wrong dose, the wrong patient, the wrong time, the wrong rate, the wrong preparation, or the wrong route of administration, excluding reasonable differences in clinical judgment on drug selection and dose;

 

(B)       Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO-incompatible blood or blood products;

 

(C)       Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a facility, including events that occur within forty-two (42) days of post-delivery and excluding deaths from pulmonary or amniotic fluid embolism, acute fatty liver or pregnancy, or cardiomyopathy;

 

(D)       Patient death or serious disability directly related to hypoglycemia, the onset of which occurs while the patient is being cared for in a facility;

 

(E)       Death or serious disability, including kernicterus, associated with failure to identify and treat hyperbilirubinemia in neonates during the first twenty-eight (28) days of life;

 

(F)       State three (3) or four (4) pressure ulcers acquired after admission to a facility, excluding progression from stage two (2) to stage three (3), if stage two (2) was recognized upon admission; and

 

(G)       Patient death or serious disability due to spinal manipulative therapy.

 

(H)       Artificial insemination with the wrong donor sperm or egg.

 

(v)                Environmental events include:

 

(A)       Patient death or serious disability associated with an electric shock while being cared for in a facility, excluding events involving planned treatments such as electric counter shock;

 

(B)       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;

 

(C)       Patient death or serious disability associated with a burn incurred from any source while being cared for in a facility;

 

(D)       Patient death or serious injury associated with a fall while being cared for in a facility; and

 

(E)       Patient death or serious disability associated with the use or lack of restraints or bedrails while being cared for in a facility.

 

(vi)       Criminal events are:

 

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

 

(B)              Abduction of a patient of any age;

 

(C)       Sexual assault on a patient within or on the grounds of a facility; and

 

(D)       Death or significant injury of a patient or staff member resulting from a physical assault that occurs within or in the grounds of a facility.

 

Section 6.        Designation of Patient Safety Officers.

 

(a)        Each licensed healthcare facility located within this state shall designate a patient safety officer and shall provide the Department with the officer’s name and contact information.

 

(b)        Through the patient safety officer, each facility shall report to the department the occurrence of any safety event happening after June 30, 2005, as described in Section 5.

Section 7.        Procedures for Healthcare Facility Safety Event Reporting.

 

(a)               The healthcare facility shall submit a report to the Department upon forms approved by the Department.

 

(b)               A person who is employed  by a healthcare facility shall, within twenty-four (24) hours after becoming aware of a safety event at the healthcare facility, notify the patient safety officer of the facility of the safety event. The patient safety officer shall, within fifteen (15) days after receiving notification, report the safety event.

 

(c)               If the patient safety officer of a healthcare facility personally discovers or becomes aware of, in the absence of notification by another employee, a safety event at the healthcare facility, the patient safety officer shall, within fifteen (15) days after discovering or becoming aware of the safety event, report the safety event to the department of health.

 

(d)               Safety event reports shall be filed in a format specified by the Department and shall identify the facility but shall not include any identifying information for any of the healthcare professionals, facility employees or patients involved.

 

Section 8.        Annual Healthcare Facility Safety Event Report Prepared by the Department.

 

(a)        Information will be collected and maintained by the Department of Health in the Preventive Health and Safety Division.

 

(b)        On or before December 31 of each year beginning in 2006, the department shall prepare and publish:

 

(i)                  A report and analysis of all reported safety events for the previous  year; and

 

(ii)        A trend analysis and recommendations for systemic improvements that is likely to enhance patient safety and healthcare.

 

(c)        The Department will ensure all referenced information is aggregated so as not to reveal the identity of any specific person or healthcare facility.

 

(d)        The report shall be made available to the public and copies forwarded to

the governor, the healthcare commission and the Joint Labor, Health and Social Services Interim Committee.

 

Section 9.        Confidentiality, Immunity and Whistle Blowing

 

(a)        Any notice, report, document and any other information compiled or disseminated pursuant to the provisions of this Chapter is confidential, is not discoverable or admissible in evidence in any administrative or legal proceeding conducted in this state, and is not a public record.

 

(b)        No contractor, employee or other member of the department who receives any notice, report, document or any other information compiled or disseminated pursuant to the provisions of this Chapter shall be permitted or required to testify in any civil action as to any evidence or any other matters presented to the Department or as to any findings, recommendations, evaluations, opinions or other actions of the department or any contractors, employees or other members thereof.

 

(c)        Information, documents or other records otherwise available from original sources are not to be construed as immune from discovery or use in any civil action merely because they were submitted to the Department, nor shall any person who provides information to the department under this Chapter be prevented from testifying as to matters within his knowledge, but that person shall not be asked about his testimony or communications with the Department.           

 

(d)        Any action authorized or required by this Chapter shall be subject to the confidentiality, immunity and whistle blowing provisions of W.S. 35-2-910 (a) and (b).

 

(e)        The State of Wyoming elects to be covered as of April 1, 2005, by the immunity granted by the Healthcare Quality Improvement Act of 1986, P.L.99-660, Title IV adopted by Congress in 1986, as authorized, for the department with respect to its duties and responsibilities under this Chapter.

 

Section 10.      Disclosure without Patient’s Authorization. 

 

A hospital may disclose healthcare information about a patient without the patient’s authorization if the disclosure is pursuant to W.S. 35-2-912.

 

Section 11.      Interpretation of Chapter.

(a)        The order in which the provisions of this Chapter appear is not to be construed to mean that any one provision is more or less important than any other provision.

 

(b)        The text of this Chapter shall control the titles of its various provisions.

Section 12.      Superseding Effect.

 

When promulgated, this Chapter supersedes all prior rules or policy statements issued by the Department, including Manuals or Bulletins, which are inconsistent with this Chapter.

 

Section 13.      Severability.

 

If any portion of this Chapter is found to be invalid or unenforceable, the remainder shall continue in full force and effect.