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Last revised: December 13, 2016 NICKLAUS CHILDREN'S HOSPITAL PATIENT SAFETY PLAN

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Last revised: December 13, 2016

NICKLAUS CHILDREN'S HOSPITAL

PATIENT SAFETY PLAN

Nicklaus Children’s Hospital Patient Safety Plan

1 of 11 Last revised: December 2016

NICKLAUS CHILDREN’S HOSPITAL

PATIENT SAFETY PLAN

Table of Contents

Executive Summary ......................................................................................................................... 2

Purpose ........................................................................................................................................... 3

Philosophy ....................................................................................................................................... 3

Goals ............................................................................................................................................... 3

Organization of the Patient Safety Program and Reporting Process ......................................... 4

Roles & Responsibilities of the Patient Safety Committee (PSC) ................................................... 4

Patient Safety Roles of Key Stakeholders ................................................................................... 6

Coordination of the Patient Safety Program .............................................................................. 7

Program Components ................................................................................................................. 7

Patient Education .................................................................................................................... 7

Patient Safety Goals ................................................................................................................ 8

Medical Staff/Staff Education ................................................................................................. 8

Patient Safety Metrics ............................................................................................................. 8

Sentinel Event Identification, Management, and Reporting ...................................................... 9

Confidentiality Statement ..................................................................................................... 10

Glossary (Selected)................................................................................................................ 11

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Nicklaus Children’s Hospital Patient Safety Plan

Executive Summary

The hospital’s Patient Safety Plan is inclusive of all healthcare providers and engages the organization in initiatives and programs that promote and support an overall milieu of safety advocacy and consciousness for patients and their families. The Patient Safety Plan is designed to promote awareness of patient safety through the encouragement of a safety-conscious culture, and to minimize complex, failure-prone processes that can lead to medical errors. The plan is governed by 2015 Florida Statute: 395.1012- Patient Safety which ensures that: (1) Each licensed facility must adopt a patient safety plan. [A plan adopted to implement the requirements of 42 C.F.R. part 482.21 shall be deemed to comply with this requirement.] (2) Each licensed facility shall appoint a Patient Safety Officer and a patient safety committee, which shall include at least one person who is neither employed by nor practicing in the facility, for the purpose of promoting the health and safety of patients, reviewing and evaluating the quality of patient safety measures used by the facility, and assisting in the implementation of the facility patient safety plan. [History.--s. 6, ch. 2003-416.] Organizational goals of the Patient Safety Program include the creation and sustainment of a safety-conscious culture; reduction of preventable adverse events through prevention and performance improvement; Interactive education throughout the organization; support of a just culture and to assess and mitigate risk factors that may threaten an environment of patient safety.

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Purpose The Patient Safety Plan is designed to promote awareness of patient safety through the encouragement of a safety-conscious culture, and to minimize complex, failure-prone processes that can lead to medical errors.

Philosophy The patient safety program at Nicklaus Children’s Hospital involves all healthcare providers in prioritizing and being champions in ensuring the overall safety of the hospital and healthcare experience. The Patient Safety Program is part of the hospital’s Integrated Safety Program. Nicklaus Children’s Hospital incorporates safety into the organization’s core values. Error-free care is a key hospital primary strategic priority.

Goals The Goals of the Patient Safety Program are to:

Ensure adherence and compliance with Patient Safety Goals Create a safety-conscious culture; Reduce preventable adverse events through prevention and targeted performance

improvement projects; Identify potential barriers to a successful patient safety program through employee

assessment and selected monitoring of patient safety; Provide an interactive and continuous educational campaign for

patients/parents/families, employees, medical staff, medical fellows and residents and individuals in training programs through open communication and the provision of educational materials;

Provide continuous, aggressive evaluation of the effectiveness of patient safety measures and proactive assessment of high risk activities and hazardous conditions, as identified through Failure Mode & Effects Analyses (FMEA) or other tools;

Improve reporting of adverse events by creating a just culture; Continuous assessment of risk factors threatening the safety of the environment and of

care delivery and initiate plans for improvement. Program Scope The scope of the Patient Safety Plan at Nicklaus Children’s Hospital incorporates the following areas:

Promoting a culture of safety; Adopting safe medical practices; Instituting safe medication-use practices; Transferring clear information through effective and efficient communication; Implementing technology that promotes patient safety and reduces errors.

The Board of Directors has the final authority and is ultimately responsible for the safety of patients.

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Organization of the Patient Safety Program and Reporting Process Patient safety information is disseminated and reported through many communication mechanisms within the organization. Information and actions related to patient safety are circulated and acted upon both from the “grassroots” at the patient care area up to the hospital’s Board of Directors. (See Figure 1)

Figure 1: Patient Safety Program Reporting

Roles & Responsibilities of the Patient Safety Committee (PSC) The Patient Safety Committee’s composition is guided by Florida Statute 395.1012 Patient Safety (2015): (1) Each licensed facility must adopt a patient safety plan. [A plan adopted to implement the requirements of 42 C.F.R. part 482.21 shall be deemed to comply with this requirement.] (2) Each licensed facility shall appoint a Patient Safety Officer and a patient safety committee, which shall include at least one person who is neither employed by nor practicing in the facility, for the purpose of promoting the health and safety of patients, reviewing and evaluating the quality of patient safety measures used by the facility, and assisting in the implementation of the facility patient safety plan. History.--s. 6, ch. 2003-416. (http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0300-0399/0395/Sections/0395.1012.html)

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Patient Safety Committee The Patient Safety Committee (PSC) reports to the Performance Improvement Council (PIC), to the Medical Executive Committee (MEC) and then to the Board of Directors (BOD) via its Quality Committee. The Patient Safety Officer is the Chief Nursing Officer/Senior Vice President. The Patient Safety Officer works jointly with the Medical Quality Leader in analyzing opportunities conducive to the safest patient care practices. The PSC shall meet at least four (4) times (quarterly) per year or as needed. The Committee will perform the following tasks:

1. Select and approve multidisciplinary patient safety projects; 2. Develop, modify, and approve the Patient Safety Plan (final approval rests with the

Board of Directors); 3. Oversee and support the Patient Safety Teams/Advocates; 4. Design and plan cross-functional and multidisciplinary patient safety systems

throughout the organization; 5. Evaluate the effectiveness of organization-wide patient safety activities; 6. Set educational/training needs for the Patient Safety Program for the Hospital; 7. Review patient safety metrics from patient satisfaction surveys, patient safety teams,

risk management reports, safety, infection control, utilization management and other dashboard indicator data that impact patient safety and ensures implementation of corrective action plans as needed

8. Communicate the status of the Patient Safety Program to the Medical and Hospital Staffs.

The composition of the Patient Safety Committee will consist of at least the following individuals or their designee:

Chief Nursing Officer/Senior Vice President, (Patient Safety Officer) Chair

Administrative Director of Inpatient Nursing and/or Director of Nursing Operations

Medical Quality Leader Chair, Medication Safety Team

President of the Medical Staff Chief Medical Information Officer

Medical Staff Representatives (2-3 members) LifeFlight® Representative

Administrative Director, Risk, Quality Safety Innovations, Infection Prevention & Control Co-chair

Nursing Representatives (Med/Surg, Critical Care & Emergency/Ambulatory)

Quality Resources Member Community Member

Chair, Pharmacy & Therapeutics Committee Administrative Director, Surgical Services

Manager, Infection Control Physician from Surgical Services

Director, Pharmacy or representative Critical Care or PACU Nurse

Family Advisory Council member Safety Officer

Clinical Engineering Member Emergency Department member

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Patient Safety Officer - The Patient Safety Officer is the Chief Nursing Officer/Senior Vice President. The Patient Safety Officer is responsible for overseeing the Patient Safety Program, including the development and modification of the Patient Safety Plan. This individual is also the spokesperson for patient safety at Nicklaus Children’s Hospital and works closely and collaboratively with the Medical Quality Leader.

Patient Safety Roles of Key Stakeholders Medical Executive Committee – The Medical Executive Committee (MEC) and its

members are responsible for the following:

Reviewing and approving patient safety activities directly or indirectly related to

the effective and safe delivery of the medical plan of care and overall clinical care

of the patient, making recommendations to prevent medical errors and ensure a

safe environment;

Review of physician compliance with the Patient Safety Goals;

Approves the Patient Safety Plan; and

Involves the Medical Staff in Departmental/Divisional patient safety

measurement, assessment, and improvement activities

Medical Staff – The Medical Staff is integral to the Patient Safety Program and responsible for the following:

Making recommendations on identified opportunities driving patient safety on issues affecting patient safety;

Overseeing mechanisms used to conduct, monitor, and evaluate patient safety activities;

Participating in Hospital-wide patient safety activities, e.g. FMEA, Root Cause Analysis (RCA), patient awareness, staff education;

Supporting multidisciplinary patient safety teams; Reporting errors for analysis; Educating patient/parents/families on patient safety as opportunities arise;

and Collaborating with the Hospital Staff to prevent errors.

Hospital Administration- The Administration will provide the support structure for the Patient Safety Program and are responsible for the following:

Allocating resources (including financial/personnel) for the assessment and improvement of patient safety;

Ensuring the continuous and systematic measurement, assessment, and improvement of internal processes/systems related to patient safety; and

Provides guidance in establishing patient safety goals and projects. Assuring full alignment with Risk, Quality, Infection Control,

Accreditation/Regulatory and other departments as they relate to the Patient Safety Program.

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Staff – The staff are integral to the Patient Safety Program and are responsible for the following:

Making recommendations to the Patient Safety Officer or the Committee on issues affecting patient safety;

Overseeing mechanisms used to conduct, monitor, and evaluate patient safety activities;

Participating in both unit-based and hospital-wide patient safety activities, e.g. FMEA, Root Cause Analysis (RCA), patient awareness education;

Participating in multidisciplinary patient safety teams; Reporting errors for analysis; Educating patient/parents/families on how they may participate in patient

safety; and Collaborating with colleagues, physicians, administration &

patient/parents/families to eliminate and prevent errors.

Patient/Parents/Families – Patient/parents/families are key to safety of self/family member and are responsible for:

Being informed about tests, procedures and medications ordered for diagnosis and treatment;

Participating in safety prevention such as, but not limited to: o Fall prevention, o Medication Error prevention, o Reducing harm from IV infiltration o Skin breakdown, o Activating Rapid Response Team (RRT) o Participating in education on safety aspects of their care; and o Reporting errors.

Coordination of the Patient Safety Program The Patient Safety Officer will coordinate the Patient Safety Program with direction from the Board of Directors Quality Committee, the Medical Executive Committee and the Performance Improvement Council with active participation and guidance from members of Administration, Medical Staff, Environment of Care and Emergency Management Committee, Quality, Safety and Innovations Department, Risk Management Department, Infection Prevention and Control Department and other areas of the Hospital as necessary to promote and maintain a culture and environment of patient safety.

Program Components

Patient Education Publications highlighting Patient Safety Falls Prevention-Humpty Dumpty Falls Assessment Program® IV Infiltrate prevention Outpatient Safety Inpatient Safety

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Medication Safety-6 Rights Food and Drug Interactions Error-proofing your home.

Patient Safety Goals

Focuses on improving patient safety and problems in health care safety and how to solve them.

Face-to-face interaction with patient/parents/families regarding patient safety initiatives Parents on the faculty of the Family Advisory Council Focus group meetings and on-line surveys of patients/families as needed CPR and first aid for family and friends Car seat safety training Hand hygiene prophylaxis and training

Medical Staff/Staff Education Publications highlighting Patient Safety

o Hospital Newsletter o Educational modules o Continuing Medical Education

Presentations o Updates at Medical Executive Committee o In-depth discussions about relevant patient safety issues at the Chiefs of

Departments/Directors or Divisional Meetings o Monthly and intermittent presentations at the Management Forum

Patient Safety Metrics The Clinical Excellence Index (CEI) is an official institutional tool designed to measure effectiveness in the delivery of safe patient care and the quality of the care experience in achieving an error-free environment. The CEI includes all metrics related to the safe delivery of care including but not limited to the Patient Safety Goals, The National Quality and Safety Forum, The Centers for Disease Control, the National Health & Safety Network and others. These metrics are monitored and reviewed on a monthly basis in order to ensure a safe environment of care through continuous improvement processes. Metrics composing the CEI include but are not limited to:

o Infection Prevention and Control measures - Hospital Acquired Infection rates - Hand Hygiene Compliance Rates (%)

o IV Therapy o Transfusions Reactions o Medication Use

- Medication errors - Adverse drug reactions

o Patient falls o Unplanned extubation

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o Skin wounds o Product/equipment injury to patient o FDA recalls/alerts o Patient/Staff satisfaction surveys as related to patient safety o Adverse Events o Patient Safety Staff/Medical Staff Opinion Survey

The hospital utilizes many benchmarking/comparative groups including but not limited to:

Children’s Hospital Association (CHA) and Pediatric Health Information System (PHIS)

Children’s Hospitals Solutions for Patient Safety (SPS)

The Healthstream® -Patient Satisfaction

Press Ganey®-Employee satisfaction and National Database of Nursing Quality Indicators

(NDNQI) measures

Florida Society Healthcare Risk Management & Patient Safety (FSHRMPS)

Cardio Systems (Cardiac Surgery)

Extracorporeal Life Support Organization (ELSO)

National Health Safety Network (formerly NNIS)

National Nosocomial Infection Surveillance Survey (NNIS)

National Pediatric Trauma Registry (TQIP)

National Surgical Quality Improvement Program (NSQIP)

Vermont Oxford Network (VON)

National Registry for Cardio Pulmonary Resuscitation (NRCPR)

Virtual Pediatric Systems (VPS)

Sentinel Event Identification, Management, and Reporting Root Cause Analysis (RCA) Near Miss Evaluation Process Development and implementation of corrective action plans

Program Evaluation Process Evaluation of the objectives, scope, and organization of the Patient Safety Plan will be performed at least annually, by Patient Safety Committee with input from the hospital and Medical Executive Committee (MEC). The Board of Directors (BOD) via its Quality Committee will review and approve changes made to the plan. The evaluation will focus on achievement of plan objectives, and the effectiveness of the safety improvement initiatives and in the inclusion of focus areas/opportunities identified after approval of the annual Safety Plan.

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Confidentiality Statement

All information related to organizational performance improvement activities including Safety activities performed by the hospital or Medical Staff in accordance with this plan are confidential. Information may be disseminated as required by law and on a “need to know” basis to agencies such as federal review agencies, National Practitioner’s Data Bank, or other individuals or agencies as approved by the Medical Executive Committee, Hospital Administration, and/or the Board of Directors. Records, data, and knowledge collected by or for the Patient Safety Committee/ Performance Improvement Council for the purpose of review shall be confidential. All information regarding incidents and sentinel events and all information documented in the incident reports is confidential. All proceedings and documents generated by the root cause analysis teams shall be afforded the highest level of confidentiality and shall be treated as peer review confidential and attorney client privileged information as appropriate.

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Glossary (Selected) Appropriateness: The degree to which the intervention provided is relevant to the patient’s clinical needs, given the current state of knowledge. Availability: The degree to which the appropriate care/intervention is accessible to meet the patient’s needs. Compliance: To act in accordance with stated requirements, such as standards. Effectiveness: The degree to which the care/intervention is provided in the correct manner, given the current state of knowledge, in order to achieve the desired outcome(s) for the patient. Failure Modes and Effects Analysis (FMEA): A proactive approach to reducing the potential for risk and adverse outcomes.

Process Improvement: Continuous efforts to identify and evaluate processes/ systems and to use this knowledge to reduce variation and complexity and improve quality. Root Cause Analysis: A retrospective, intense evaluation of an adverse event or patterns and trends that vary significantly from standards of practice or what’s expected. Safety: The degree to which the risk of an intervention and the risk in the care environment are reduced for the patient and others, including the health care provider.

Sentinel Event: A sentinel event is “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof”. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called sentinel because they signal the need for immediate investigation and response. Organizations must complete a root cause analysis (RCA), or in-depth investigation, to determine why a sentinel event occurred.