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 -1-