House Amendment 8335
PAG LIN
1 1 Amend the amendment, H=8309, to House File 2716, as
1 2 follows:
1 3 #1. Page 1, by inserting after line 1 the
1 4 following:
1 5 <# . Page 1, by inserting before line 1 the
1 6 following:
1 7 <Section 1. NEW SECTION. 135N.1 TITLE.
1 8 This chapter shall be known and may be cited as the
1 9 "Patient Safety and Quality Assurance Act".
1 10 Sec. 2. NEW SECTION. 135N.2 DEFINITIONS.
1 11 As used in this chapter:
1 12 1. "Action plan" means a written plan prepared
1 13 after a root cause analysis that identifies strategies
1 14 that a health care provider intends to implement to
1 15 reduce the risk and reoccurrence of actual and
1 16 potential risks to patient safety. The plan shall
1 17 address health care provider responsibility for
1 18 implementation, oversight, pilot testing as
1 19 appropriate, timelines, and strategies for measuring
1 20 the effectiveness of the actions.
1 21 2. "Health care provider" means a physician or
1 22 surgeon, osteopath, osteopathic physician or surgeon,
1 23 dentist, podiatric physician, optometrist, pharmacist,
1 24 chiropractor, or nurse licensed in this state, a
1 25 hospital licensed pursuant to chapter 135B, or a
1 26 health care facility licensed pursuant to chapter
1 27 135C.
1 28 3. "Health care provider leaders" means a health
1 29 care provider, executive, physician as defined in
1 30 section 135C.1, registered or licensed practical nurse
1 31 or nurse practitioner, or health care provider
1 32 administrator.
1 33 4. "Quality assessment and assurance activities"
1 34 means the procedure by which a quality assessment and
1 35 assurance committee monitors, evaluates, recommends,
1 36 and implements actions to improve and assure the
1 37 delivery and quality of services and patient safety
1 38 through identification, correction, and prevention of
1 39 sentinel events.
1 40 5. "Quality assessment and assurance committee"
1 41 means a committee of a health care provider consisting
1 42 of individuals responsible for the identification of
1 43 sentinel events that may adversely impact the health
1 44 and safety of patients, and for the development of
1 45 root cause analyses, action plans, and other plans to
1 46 correct identified quality of care issues. The
1 47 quality assessment and assurance committee shall
1 48 include health care provider leaders, including but
1 49 not limited to the health care provider administrator
1 50 and the director of nursing.
2 1 6. "Quality assessment and assurance committee
2 2 records" means complaint files, investigation files,
2 3 reports, and other investigative information relating
2 4 to licensee discipline or professional competence in
2 5 the possession of a quality assessment and assurance
2 6 committee or an employee of the committee.
2 7 7. "Risk of death or serious injury" means any
2 8 variation in a process related to quality of care or
2 9 patient safety which may result in a serious adverse
2 10 outcome.
2 11 8. "Root cause analysis" means the process for
2 12 identifying causal factors that relate to any
2 13 variation in the delivery and quality of services and
2 14 patient safety, including the occurrence or possible
2 15 occurrence of a sentinel event. A root cause analysis
2 16 focuses primarily on systems and processes, and not on
2 17 individual performances.
2 18 9. "Sentinel event" means an unexpected occurrence
2 19 resulting in the death or serious physical or
2 20 psychological injury of a patient of a health care
2 21 provider, or a risk of death or serious physical or
2 22 psychological injury to a patient of a health care
2 23 provider.
2 24 10. "Unanticipated outcome" means a result that
2 25 differs significantly from what was anticipated to be
2 26 the result of a treatment or procedure, including an
2 27 outcome caused by an error of an employee of a health
2 28 care provider or an independent practitioner who
2 29 provides medical services at a health care provider's
2 30 facility.
2 31 Sec. 3. NEW SECTION. 135N.3 ACCOUNTABILITY OF
2 32 HEALTH CARE PROVIDER LEADERS.
2 33 The health care provider leaders, including the
2 34 health care provider administrator and director of
2 35 nursing, and the quality assessment and assurance
2 36 committee, are responsible for all of the following:
2 37 1. Assuring the implementation of an integrated
2 38 patient safety program throughout the health care
2 39 provider facility. The patient safety program shall
2 40 include, at a minimum, all of the following:
2 41 a. A designation of one or more qualified
2 42 individuals or an interdisciplinary group to manage
2 43 the health care provider safety program.
2 44 b. A definition of the scope of the program
2 45 activities, including the types of occurrences to be
2 46 addressed.
2 47 c. A procedure for immediate response to medical
2 48 or health care errors or patient abuse, including care
2 49 of an affected patient, containment of risk to others,
2 50 and the preservation of factual information for
3 1 subsequent analysis.
3 2 d. A system for internal and external reporting of
3 3 information relating to medical and health care errors
3 4 or patient abuse.
3 5 e. A defined mechanism for support of staff
3 6 involved in a sentinel event.
3 7 f. An annual report to the department of
3 8 inspections and appeals concerning medical or health
3 9 care errors and patient neglect or abuse, and actions
3 10 taken to improve patient safety, both proactively and
3 11 in response to actual occurrences.
3 12 2. Defining and implementing processes for
3 13 identifying and managing sentinel events, including
3 14 establishing processes for the identification,
3 15 reporting, analysis, and prevention of sentinel events
3 16 and assuring the consistent and effective
3 17 implementation of a mechanism to accomplish those
3 18 activities.
3 19 3. Establishing a continuous proactive program for
3 20 identifying risks to patient safety and reducing
3 21 medical and health care errors and patient neglect or
3 22 abuse.
3 23 4. Allocating adequate resources for measuring,
3 24 assessing, and improving patient safety.
3 25 5. Assigning personnel to participate in
3 26 activities to improve patient safety and providing
3 27 adequate time for personnel to participate in such
3 28 activities.
3 29 6. Providing staff training on the improvement of
3 30 patient safety.
3 31 7. Allocating physical and financial resources to
3 32 support safety improvement.
3 33 8. Analyzing undesirable patterns or trends in
3 34 staff performance and sentinel events.
3 35 9. Assuring the health care provider identifies
3 36 changes for improved patient safety.
3 37 Sec. 4. NEW SECTION. 135N.4 PATIENT RIGHTS AND
3 38 DUTY OF DISCLOSURE.
3 39 1. Patients and their immediate families have a
3 40 right to know about the quality of care outcomes
3 41 involved in patient care, including unanticipated
3 42 outcomes and sentinel events.
3 43 2. The health care provider leaders shall fully
3 44 disclose all of the facts and circumstances relating
3 45 to a sentinel event or an unanticipated outcome.
3 46 Sec. 5. NEW SECTION. 135N.5 SENTINEL EVENT
3 47 REPORTING.
3 48 1. A health care provider involved in a sentinel
3 49 event shall submit a root cause analysis and an action
3 50 plan that describes the health care provider's risk
4 1 reduction strategy and a strategy for evaluating the
4 2 effectiveness of the risk reduction strategy to the
4 3 department of inspections and appeals.
4 4 2. A root cause analysis shall contain an analysis
4 5 focusing primarily on systems and processes involved
4 6 in quality of care and patient safety which includes
4 7 changes that may be made to such systems and
4 8 processes, and shall be thorough, credible, and
4 9 acceptable as defined by industry standards.
4 10 Sec. 6. NEW SECTION. 135N.6 CONFIDENTIALITY OF
4 11 RECORDS.
4 12 1. Quality assessment and assurance committee
4 13 records shall be confidential and privileged and shall
4 14 not be subject to discovery or subpoena.
4 15 2. Information or documents discoverable from
4 16 sources other than a quality assessment and assurance
4 17 committee, a health care provider, or the department
4 18 of inspections and appeals do not become
4 19 nondiscoverable from the other sources because they
4 20 are subject to a claim of confidentiality under this
4 21 section.>>
4 22 #2. By renumbering as necessary.
4 23
4 24
4 25
4 26 R. OLSON of Polk
4 27 HF 2716.503 81
4 28 rh/je/1392
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