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Health Care Facility Safety Event Reporting
The Wyoming Department of Health proposes the following rules to comply with the provisions of 2005 General Session, Enrolled Act No. 104 [PDF] (to be codified at W.S. §35-2-912), which authorizes the Department of Health to promulgate rules to establish Healthcare Facility Safety Event Reporting, and the Wyoming Administrative Procedures Act at W.S. 16-3-101 et seq. We are promulgating this rule due to the immediately-upon-passage effective date of this Legislation. The proposed rules:
Establish health care facility safety event reporting relating to health care facilities; providing for mandatory reporting of safety events by health care facilities to the Department as specified; requiring an annual report of safety events by the Department; providing for confidentiality; providing for immunity; providing definitions; providing a sunset date; providing an appropriation; and providing for an effective date.
Establish general requirements for health care facilities to designate a patient safety officer and report to the Department of Health, Preventive Health and Safety Division the occurrence of any safety event occurring after June 30, 2005. The Department will develop and implement a reporting system for a health facility to submit timely reports of safety events. Outline Department authority to require submission of health care facility safety event reports and related information to the Department of Health and to comply with all provisions of the Act.
Establish general requirements for the Department to collect and maintain information on health care facility safety events in this state. The Department will prepare and publish an annual report on or before December 31 of each year all reported safety events for the previous year and provide a trend analysis for systemic improvements to enhance patient safety and health care. Referenced information is to be aggregated so as not to reveal the identity of individuals or health care facilities. Any act authorized or required herein is subject to the confidentiality, immunity and whistle blowing provisions of W.S. §35-2-910 (a) and (b). Health care information may be disclosed to the Department of Health without the patient's authorization if disclosed pursuant to this Act.
Regulations for Health Care Facility
Safety Events to be Reported
Designation of Patient Safety Officers
Reporting Procedures for Health Care Facility Safety Event
Statewide Annual Safety Event Report
Confidentiality, Immunity and Whistle Blowing
Disclosure without Patient's Authorization
Section 1. – Authority.
This Chapter is promulgated by the Department pursuant to the provisions of 2005 General Session, Enrolled Act No. 104 [PDF] (to be codified at W.S. §35-2-912), which authorizes the Department to promulgate rules to establish Health Care Facility Safety Event Reporting, and the Wyoming Administrative Procedures Act at W.S. 16-3-101 et seq.
Section 2. – Purpose and Applicability.
(a) These rules shall apply to and govern Health Care Facility Safety Event Reporting. They shall become effective upon adoption for all health care 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 2005 General Session, Enrolled Act No. 104 [PDF] (to be codified as 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.
(a) "Act" means 2005 General Session, Enrolled Act No. 104 [PDF] (to be 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) "Disability" means restriction or limitation resulting from an impairment of ability to perform an activity in a manner or with the range considered normal for a human being, according to the International Classification of Impairments, Disabilities, and Handicaps first published in 1908 by the World Health Organization. The term disability reflects the consequences of impairment.
(f) "Documentation" means written evidence, in the form specified by the Department, to support an assertion or position.
(g) "Health care facility" means any licensed health care facility in the State of Wyoming.
(h) "Hospital" means a health care facility where the sick or injured are given medical or surgical care.
(i) "Hyperbilirubinemia" means billirubin levels greater than thirty (30) milligrams per deciliter.
(j) "Injury" means damage, harm, hurt, or impairment; trauma.
(k) "Patient" means an individual under medical care, treatment or medical Services.
(l) "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.
(m) "Reporting" means Health Care Facility Safety Event Reporting created by the Act and implemented by this Chapter.
(n) "Public records" means "Public records" as defined in W.S. 16-4-201(a)(v), which is incorporated by this reference.
(o) "Safety event" means an unexpected occurrence involving death or serious physical or psychological injury or the risk there of, including:
( i ) Surgical events as defined at W.S. §35-2-912;
(ii) Product or device events as defined at W.S. §35-2-912;
(iii) Patient protection events as defined at W.S. §35-2-912;
(iv) Care management events as defined at W.S. §35-2-912;
(v) Environmental events as defined at W.S. §35-2-912; and
(vi) Criminal events as defined at W.S. §35-2-912.
(p) "Sexual assault" means in law, indecent conduct of a man toward another man, a woman, or a child or of a woman toward a child, accompanied by the threat or danger of physical suffering or injury or inducing fear, shame, humiliation, and mental anguish.
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 in the specified report format:
(i) Surgical events including:
(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 present 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 including:
(A) The use of contaminated drugs, devices or biologics provided by the facility when the contamination is the result of generally detectable 2-3 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 of 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.
(v) Environmental events including:
(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 including:
(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 on the grounds of a facility.
Section 6. – Designation of Patient Safety Officers.
(a) Each licensed health care 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 Health Care Facility Safety Event Reporting.
(a) The health care facility shall submit a report to the Department upon forms approved by the Department.
(b) A person who is employed by a health care facility shall, within twenty- four (24) hours after becoming aware of a safety event at the health care 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 health care facility personally discovers or becomes aware, in the absence of notification by another employee, of a safety event at the health care 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.
(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 health care professionals, facility employees or patients involved.
Section 8. – Annual Health Care Facility Safety Event Report Prepared by the Department.
(a) Information will be collected and maintained by the Department 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 are likely to enhance patient safety and health care.`
(c) The Department will ensure all referenced information is aggregated so as not to reveal the identity of any specific person or health care facility.
(d) The report shall be made available to the public and copies forwarded to the governor, the health care 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 Health Care 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 health care 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.
Section 14. – Penalty for violations.
According to Title 35 Public Health and Safety, Chapter 1 Administration, Article 1 In General, 36-1-106, any person who shall violate any of the provisions of this act, or any lawful rule or regulation made by the state department of health pursuant to the authority herein granted, or who shall fail or refuse to obey any lawful order issued by any state, county or municipal health officer pursuant to the authority granted in this act shall be deemed guilty of misdemeanor, and shall be punished except as otherwise provided therein by a fine or not more than one thousand dollars ($1,000.00), or by imprisonment for not more than one (1) year or by both such fine and imprisonment.