PAGE #: 1 of 8 CROSS REFERENCES: Administrative Policy PI-01: Unanticipated Adverse Patient Events Administrative Policy PI-04: Patient Safety Plan Administrative Policy PI-07: Incident Reporting System INTRODUCTION Risk reduction, loss prevention, risk mitigation, and improving patient safety are long-established risk management concepts. The hospital patient safety initiatives provide additional resources to reduce medical error and improve patient outcomes. This document will describe our Risk Management Program and how we work together with Patient Safety to identify and address patient safety issues. BACKGROUND Maryland Medicine Comprehensive Insurance Program Self Insurance Trust (the Trust) is a joint venture established by the University of Maryland Medical System Corporation (UMMS) and Faculty Physicians, Inc. (FPI) to provide self insurance, risk financing, and risk management services. The plan of insurance (the Plan) covers virtually all professional employees engaged in rendering health care services at Shore Health System. AUTHORITY The Board of Directors of the University of Maryland Medical System and the Board of Directors of Shore Health System support the Risk Management Program of Shore Health System and shall retain overall responsibility and authority for the Risk Management Program. The Risk Management Program is a collaborative effort between the Administration and the Shore Health System Board of Directors as part of the University of Maryland Medical System. The MMCIP Board of Directors requires establishment of a program to manage its professional liability risks and the general review of the quality of care rendered. PURPOSE The program provides a vehicle to self-insure primary losses resulting from certain liability (including but not limited to professional and general) of Shore Health System and covered persons as specified in the Insurance Plan; arranges for reinsurance above its self-insured retention; and develops, implements and maintains a system-wide comprehensive risk management program consisting of: Incident and claims data analysis to identify system issues Initiatives to improve patient outcomes and reduce medical errors Education programs and literature on risk management and patient safety for medical, nursing and other staff providing care to patients Evaluation process to measure effectiveness of risk management/patient safety initiatives to improve patient outcomes Aggressive claims management Protection of financial assets Implementation of loss prevention methodologies 1
PAGE #: 2 of 8 1.0 ORGANIZATIONAL STRUCTURE OF RISK MANAGEMENT 1.1 Board of Directors The Board of Directors for the Trust and the Board of Directors for the Terrapin Insurance Co., Ltd, have fiduciary and administrative responsibility for the entire Plan of Insurance provided throughout MMCIP. The Board consists of twelve (12) voting members, of which UMMS appoints six (6) and FPI appoints six (6). Historically, the Chairman of the Board rotates every two (2) years between the President of the University of Maryland Medical System and the Dean of the School of Medicine. Each Board meets periodically during the year. 1.2 Finance Committee The Finance Committee is a subcommittee of the Board that provides financial oversight and underwriting approval. The committee meets on a monthly basis. 1.3 Claims Risk Management Committee 1.3.1 The Claims Risk Management Committee (CRMC) provides on-going internal review of potential and active claims and settlements and recommends resolutions as applicable. Its responsibilities include, but are not limited to: 1.3.1.1 Providing expert clinical and administrative advice in claims and suits as requested. 1.3.1.2 Participating in identification of risk management issues/system issues and recommending appropriate actions. 1.3.1.3 Assessing for barriers and/or deficits to provide safe patient care. 1.3.1.4 Identifying loss prevention strategies and promotion of improving patient outcomes. 1.3.1.5 Exploring strategies to assist legal counsel in the defense of matters in litigation and pre-litigation. 1.3.2 The committee meets monthly and is comprised of senior administration and clinical/departmental chair or designee (physicians), the Director of Claims and Litigation, the Vice President of Claims, Litigation, and Risk Management, and the Chief Executive Officer of the MMCIP. 1.3.3 Additionally, the committee may request a department representative (physician or nurse manager) from a specific clinical area to attend for review of a specific case. Risk Managers assigned to the department or facility for a particular case will also be in 2
PAGE #: 3 of 8 attendance. Recommendations of the CRMC may be brought to the Finance Committee as needed. 1.4 Office of Risk Management 1.4.1 The Office of Risk Management (ORM), reports directly to the MMCIP Board of Directors and serves as the central area of accountability and responsibility for risk management, loss prevention, claims management and insurance activities. In this capacity, the ORM works closely with department heads and key administrators, especially with Quality Improvement. 1.4.2 Responsibilities of the Office of Risk Management include, but are not limited to: 2.0 INCIDENT REPORTING PROCESS 1.4.2.1 Identify and assess loss potential throughout the Medical System. 1.4.2.2 Develop, implement and monitor the effectiveness of loss control and loss prevention programs targeted to improve patient safety and reduce liability. 1.4.2.3 Actively participate on multiple hospital committees related to improving patient and employee safety. 1.4.2.4 Develop and maintain cost effective funding and risk financing programs. 1.4.2.5 Contain losses through the establishment of an effective in-house claims and litigation management program. New employees of Shore Health System are introduced to the importance of all types of incident reporting in their orientation programs by the Risk Manager and risk management education coordinator. 2.1 Purpose 2.1.1 Incident Reporting provides a mechanism to identify and address actual and potential risks (near misses) as well as to obtain information to promote patient safety, improve delivery of patient care and minimize injury and loss. Reports are designed to capture deviations from established standards and guidelines whether they result in an injury or not. The purpose of reporting is to be proactive and improve systems to minimize harm. Prompt reporting is essential to gather the facts about the incident and support staff with information on documentation and communication. (See Administrative Policy PI-07: Incident Reporting System) 3
PAGE #: 4 of 8 2.1.2 Incident reporting includes incidents, adverse events, near misses and sentinel events. 1 Reporting of incidents is the first step to identifying issues and trends requiring resolution to minimize future injury and loss and are to be reported as soon as possible after an event. 2.1.3 All efforts are taken to encourage active reporting of incidents including: 2.1.3.1 Blameless reporting. 2.1.3.2 Reporting via telephone, in person, via email, via the online incident reporting system. 2.1.4 Telephone reports should include patient (or visitor) name, medical record number, unit/department, date and time, brief description of incident, patient outcome and the incident reporter s name and phone number, in case there are additional questions. The online incident report form is to be completed in a factual and objective manner without personal opinion or speculation. All incident reports are confidential and made pursuant to the evaluation and improvement of quality health care functions set forth in Section 1-401 of the Health Occupations Article of the Annotated Code of Maryland and is intended as a record of a medical review committee as defined in that statute. 2.1.5 All employees and medical staff are expected to participate in incident reporting. Incidents that must be reported include, but are not limited to, the incident/adverse events that: 2.1.5.1 Result in death or serious disability (Level 1). 2.1.5.2 Require medical intervention to prevent death or serious disability (Level 2). 2.1.5.3 Meet the definition of serious adverse events as defined by the UMMS Serious Adverse Events Committee. 2.1.5.4 All other adverse events (Level 3). 1 Incident: Any event or complication which is not consistent with the routine care of patients or injury to a visitor. It includes environmental conditions, or equipment problems which might be hazardous to the safety of patients or visitors. Adverse Event: An unexpected occurrence related to an individual s medical treatment and not related to the natural course of the patient s illness or underlying disease condition. Near Miss: A situation that could have resulted in an adverse event but did not, either by chance or through timely intervention. Sentinel Event: 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. (TJC) 4
PAGE #: 5 of 8 2.1.5.5 Was prevented and does not reach the patient (near miss). 2.1.5.6 Are related to delays in diagnostic or therapeutic treatment. 2.1.5.7 Involve medical equipment which could have malfunctioned causing harm or potential harm to a patient. 2.1.5.8 Is a patient complaint involving the quality of care. 2 2.1.5.9 Patient may have experienced at another Maryland hospital before transfer to Shore Health System. 2.1.5.10 Any event that may adversely affect patient safety 2.1.6 Document the event in the medical record in a factual, objective manner without personal opinion or speculation. The physician s findings of the patient condition should be documented. Do not mention risk management or incident report in the medical record. 2.2 Response to an Adverse Event or Negative Change in Patient s Condition Whenever a patient s condition deteriorates, immediate medical and nursing interventions are provided. A change in the patient s condition could be the result of the patient s illness, known complication of a treatment or procedure, an error in treatment/procedure or an unknown etiology. Any immediate interventions to prevent a reoccurrence of the event should be initiated and communicated to other appropriate healthcare providers. For example, if medical equipment is known or suspected of a malfunction, it should be labeled as such, sequestered and BioMedical called to analyze the equipment. Serious incidents with significant injury or obvious adverse changes in the patient s condition must be reported to risk management as soon as possible (after the patient care is provided) by telephone. If serious incidents occur during non-business hours, risk management staff is available 24/7. Department managers, nurse managers and the attending/treating physician should also be notified. Prompt reporting is essential for risk management to gather the facts about the incident and support staff with information on documentation, communication, and disclosure. 3.0 OVERVIEW OF INCIDENT EVALUATION PROCESS 3.1 Evaluation of Incidents 3.1.1 All reported incidents involving patients or visitors are reviewed in the Office of Risk Management. 2 Patient complaints are channeled to the Director of Patient/Family Advocacy and analyzed to identify and address patient safety issues via the Quality Improvement structure. Only those complaints involving potential litigation need to be specifically reported to risk management. 5
PAGE #: 6 of 8 3.1.2 An initial review of the incident indicates the severity of the event and whether an in-depth investigation is required. All incident reports are entered into a database. Issues, patterns and trends are identified via data analysis and from general review of reported incidents and with an information management system. Loss control methods and patient safety initiatives are identified and forwarded to quality improvement and other administrative leadership, as appropriate. Implementation of loss prevention includes recommendations to change policies or procedures, the design and delivery of risk management education initiatives or recommendations for system change. Issues, patterns and trends identified and recommendations to improve patient safety are also presented to the MMCIP Board at scheduled meetings and to SHS leadership. 3.1.3 Risk Managers complete the investigation which may include interviews with individuals involved in the incident, review of the medical record, uninvolved expert s review of the case and other sources of information. When the investigation is complete, the risk manager will assign a response level, (i.e. Level 1-6) 3. The Risk Manager discusses the Level 1, Level 2 or near miss events that require a root cause analysis with the Chief Medical Officer. The root cause analysis and action plan are completed as a collaborative effort within 60 days. The root cause analysis is led by the Director of Performance Measurement and Improvement. Additionally, based on the findings of the investigation a decision to reserve funds and the amount of funds is determined by risk management. 3.2 Inter-hospital Events Incidents involving transferred patients from other Maryland hospitals that may have experienced an adverse event at originating hospital will be investigated. If confirmed, the information obtained will be shared with the originating hospital risk management or medical review committee. 3.3 Communication of Claims and Incident Data Analysis 3.3.1 Many different reports are generated from the incident and claims management database to evaluate trends, issues and opportunities to improve patient safety in the medical system and in individual departments or divisions. This includes quality forums, chief of departments, nursing management and supervisors. As issues are identified, they are passed on to the appropriate leadership person along with loss prevention/patient safety recommendations based on the investigation and analysis. 3.3.2 Information related to incident report data or claims management data is confidential and discussed in the interest of reducing adverse events and improving patient outcomes. This data originates on the incident report (Medical Review Committee Report) that is 3 Level 1 An adverse event that results in death or serious disability Level 2 - An adverse event that requires a medical intervention to prevent death or serious disability Level 3 - All other adverse events Level 4 Near miss adverse event prevented; it does not reach the patient Level 5 - Occurrences that are a known complication Level 6 Occurrences that do not meet the definition of an incident 6
PAGE #: 7 of 8 made pursuant to the evaluation and improvement of quality health care functions set forth in Section 1-401 of the Health Occupations Article of the Annotated Code of Maryland and is intended as a record of a medical review committee as defined in that statute. 3.4 Communicating Unanticipated Outcomes to Patients and Families Patients are entitled to information about the potential or unexpected outcomes of diagnostic tests, medical treatments, and surgical intervention. 4 The Office of Risk Management has a process and guidelines in place to encourage and assist practitioners in the discussion of unanticipated outcomes with patients and families. 3.5 Education MMCIP provides an array of educational opportunities on risk management/ patient safety topics to attending physicians, residents, nursing and hospital staff. Education programs are based on a needs assessment and analysis of claims data. Orientation programs emphasize the importance of reporting, introductory concepts of systems analysis, risk management and patient safety principles. Communication among health care providers of various disciplines, documentation of the care provided, application of good clinical judgment, using the chain of command and disclosure are among the major issues emphasized in orientation and other education programs. Risk management education programs include, but are not limited to staff meetings, conferences, general medical staff meetings, continuing education programs, departmental or unit based programs. Programs are individualized to specific departmental risk management and patient safety issues. 3.6 Visitor Incidents Visitor incidents including, but not limited to, falls, assaults or misconduct occurring in the nursing or clinical areas are reported to the Office of Risk Management. Visitors alleging injury should be encouraged to visit an emergency room. Under no circumstances should any guarantee of bill abatement be given. 4.0 INTEGRATION OF RISK MANAGEMENT WITH PATIENT SAFETY 4.1 The Risk Manager works closely with Patient Safety via monthly committee meetings. 4.2 Reports to the Office of the Chief Medical Officer On an ongoing basis, the Office of Risk Management participates in the appointment / reappointment process by: 4 TJC patient safety standard RI 1.2.2: Responsible licensed independent practitioner or his/her designee clearly explains the outcome of any treatments or procedures to the patient and when appropriate, the family, whenever those outcomes differ significantly from anticipated outcomes. 7
PAGE #: 8 of 8 4.2.1 Reviewing for approval/disapproval application for professional liability coverage through MMCIP submitted by members of the professional staff. 4.2.2 Verifying dates of MMCIP coverage for professional staff. 4.2.3 Notifying all insureds of the terms and conditions of their coverage. 4.2.4 Providing claims histories/loss histories to authorized parties upon request. 4.2.5 Reporting settled claims/suits to the National Practitioner Data Bank, if applicable. Effective 01/01 Revised 05/02 Approved SHS Board of Directors (05/22/02) Revised 08/03 Approved SHS Board of Directors (08/03) Revised 02/06 Approved SHS Board of Directors (02/22/06) Revised 07/13 Submitted Kim Billingslea, Director Patient / Family Advocacy MMCIP Program Risk Management Plan Appendix I: Flow Diagram of Incident Evaluation Process 8