UPMC POLICY AND PROCEDURE MANUAL POLICY: INDEX TITLE: HS-PT1200 Patient Safety SUBJECT: Reportable Patient Events DATE: December 4, 2015 I. POLICY It is the policy of UPMC to encourage and promote a philosophy of continual performance improvement and to assure that its affiliated health care facilities meet the patient safety requirements of The Joint Commission ( TJC ) and the Pennsylvania Medical Care Availability and Reduction of Error ( MCARE ) Act, 40 P.S. 1303.101, et. seq., in addition to other healthcare accrediting bodies, by: 1) identifying and categorizing all Reportable Patient Events; 2) conducting appropriate investigations and analyses of such events; 3) creating and implementing necessary and appropriate corrective actions to improve the quality of patient care; and 4) reporting Reportable Patient Events to TJC, the Pennsylvania Department of Health ( DOH ) and/or the Pennsylvania Patient Safety Authority, as appropriate. Therefore, each hospital and other designated health care facility shall establish, implement and follow a Patient Safety/Quality Peer Review Policy (or other designated policy) in substantial compliance with this Policy. Links to policies referenced within this policy can be found in Section VI. II. SCOPE This policy applies to all United States based UPMC s long-term care facilities, acute hospitals, hospital based facilities, ambulatory surgical center, birth centers, and postacute service providers. III. PURPOSE To establish criteria and guidelines for personnel to report events involving actual or threatened harm to patients. IV. DEFINITIONS The following definitions shall be used in each facility s policy: A. Corrective Action: Any action recommended or taken to promote patient safety as a result of retrospective investigations and/or analyses of Reportable Patient Events or prospective analyses of existing practices, procedures, policies or systems.
PAGE 2 B. IIER: An Initial Incident/Event Report (IIER) is used to identify and report Reportable Patient Events. This form can be prepared manually (on paper) or electronically by using Risk Master. C. Incident: An incident, as defined by MCARE, is an event, occurrence or situation involving the clinical care of a patient which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient. D. Infrastructure Failure: An Infrastructure Failure, as defined by MCARE, is an undesirable or unintended event, occurrence or situation involving the Infrastructure of a medical facility or the discontinuation or significant disruption of a service, which could seriously compromise patient safety. E. Infrastructure: Infrastructure, as defined by MCARE is a structure related to the physical plant and service delivery systems necessary for the provision of health care services in a medical facility. F. Joint Commission: G. Medical Care Availability and Reduction of Error Act: H. Medication Event: I. Patient Safety Authority: The Joint Commission (TJC) evaluates and accredits more than 15,000 health care organizations (including all UPMC hospitals) and programs in the United States. Among other things, The Medical Care Availability and Reduction of Error (MCARE) Act defines what types of patient events are reportable to the Commonwealth of Pennsylvania and to patients, establishes certain patient safety initiatives, establishes the Patient Safety Authority, and defines the parameters for which the Commonwealth of Pennsylvania will provide medical professional liability insurance for certain health care providers. Either an Incident or Serious Event involving the ordering, prescription, dispensing, administration or use of medications to a patient that results in an unanticipated injury or harm or which could, if repeated, result in unanticipated injury or harm. The Patient Safety Authority ( Authority ) is an independent state agency established under the MCARE Act. It is charged with taking steps to reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety in hospitals, ambulatory surgical facilities, birthing centers and certain abortion facilities. The Authority has implemented PA- PSRS, the mandatory statewide Pennsylvania Patient Safety Reporting System.
PAGE 3 J. MCARE Patient Safety Committee: K. Patient Safety Officer: L. Patient Safety/Peer Review Committee ( the Committee ). M. Pennsylvania Department of Health: N. Reportable Patient Event: The Patient Safety Committee, as defined by the MCARE Act, is a Committee composed of the Patient Safety Officer, at least three health care workers of the medical facility and two residents of the community served by the medical facility that carries out the obligations and functions of such Committee as defined in the MCARE Act, which include, but are not limited to, receiving reports from the patient safety officer, evaluating patient safety investigations, evaluating the quality of patient safety measures, making recommendations to eliminate future serious events and incidents, and making quarterly reports to reporting to the administrative officer and governing body of the medical facility regarding reportable patient events and recommendations for eliminating future serious events and incidents. MCARE requires every health care facility to designate a Patient Safety Officer. The Patient Safety Officer shall serve on the Patient Safety Committee, ensure the investigation of all reports of serious, events and incidents, take such action as is immediately necessary to ensure patient safety as a result of any investigation, and report to the Patient Safety Committee regarding any action taken to promote patient safety as a result of investigations commenced pursuant to this section, as specified in the MCARE Act. A committee consisting of health care providers, hospital administrators and staff who evaluate the quality and efficiency of services ordered or performed by a hospital or other health care provider and/or the compliance of a hospital or other health care facility with applicable standards, laws, rules and regulations. The Pennsylvania Department of Health ( DOH ) is the regulatory body responsible for planning and coordinating health resources throughout the Commonwealth. It also licenses and regulates a variety of health facilities, such as hospitals, nursing homes, ambulatory surgical facilities and other in-patient and out-patient facilities. Any Incident, Medication Event, Serious Event or Infrastructure Failure as defined by MCARE or Sentinel Event as defined by TJC. O. Reporters: Staff members, physicians, employees, volunteers, students or other persons who gain knowledge of a Reportable Patient Event and have an obligation to report the event.
PAGE 4 P. Risk Master: Risk Master is a database driven health and safety software system that is used by UPMC to track Reportable Patient Events under MCARE, Sentinel Events, and any other matters for which the system may have legal exposure. In addition, Risk Master is a useful tool to capture information for quality improvement purposes. Q. Root Cause Analysis: A root cause analysis (RCA) is structured method for identifying the underlying reasons of why an adverse event occurred. R. Sentinel Event: A Sentinel Event as defined by TJC 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. The subset of events deemed sentinel includes any occurrence that meets the following criteria: (1.) The event has resulted in an unanticipated death or major permanent loss of function, not related to the natural course of the patient s illness or underlying condition or (2.) The event is one of the following: (a.) suicide of a patient in a setting where the patient receives round-the-clock care; or within 72 hours of discharge (b.) unanticipated death of a full term infant; (c.) abduction of any individual receiving care, treatment or services; (d.) infant discharge to the wrong family; (e.) rape (by another patient, staff, or a visitor); (f.) Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities; (g.) surgery on the wrong patient or wrong body part; (h.) unintended retention of a foreign object in an individual after surgery or other procedure; or (i.) death and major permanent loss of function attributed to a nosocomial infection (i.e., except for the infection, the patient would probably not have died or suffered loss of function); (j.) severe neonatal hyperbilirubinemia (bilirubin >30 milligrams/deciliter); (k) prolonged fluoroscopy with cumulative dose > 1500 rads to a single field or any delivery of radiotherapy to the wrong body region or > 25% above the planned radiotherapy dose. S. Serious Event: A Serious Event, as defined by the MCARE Act is an event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an Incident.
PAGE 5 V. PATIENT SAFETY/QUALITY PEER REVIEW POLICIES Each UPMC United States based hospital, ambulatory surgical center, birth center, longterm care facility, or post-acute business entity shall develop, adopt and enforce a reportable event policy (or other designated policy) that includes the following provisions. A. Internal Reporting of Reportable Patient Events 1. Each facility s policy shall establish a system whereby Reporters can report Reportable Patient Events 24 hours per day/7 days per week. B. Initial Identification of Serious Events, Sentinel Events and Infrastructure Failures. Each facility s policy shall include a process whereby: 1. Reporters who gain knowledge of events that they believe have, or if repeated, could compromise patient safety or cause significant patient injury, are required to immediately input such information into Risk Master, or communicate the event or incident to the Risk Management Specialist or Patient Safety Officer and/or other member(s) of the Committee delegated to review such events in the facility s Patient Safety Plan. 2. The Committee shall, inter alia, receive notice of all Incidents, Serious Events, Infrastructure Failures and/or Sentinel Events. 3. The Patient Safety Officer (or his or her designee) or Risk Management on behalf of the Committee after consultation with appropriate senior/executive management, if it is determined that any delay in responding to the event could result in: (1) continuing or further harm to patients, staff or others; (2) significant disruption of a necessary hospital function, process or operation; (3) significant potential for undermining the public s confidence in the organization; or (4) the destruction, loss or unavailability of any information, thing or person that may be necessary to conduct a reasonable investigation of the event, shall be empowered to take whatever immediate steps are deemed necessary to address the situation. 4. Any retrospective review of patient care by any person, department or committee shall include a determination whether there exists or existed any potential Serious Event, Sentinel Event or Infrastructure Failure. 5. Grievances made by external parties are reviewed to determine whether they concern a Reportable Event not otherwise identified.
PAGE 6 C. Review of Initial Incident/Event Reports (IIER s). Each facility s policy shall establish an IIER policy and procedure whereby: 1. Every clinical event reported on an IIER (prepared manually or through Risk Master) shall be reviewed on behalf of the Committee to determine if the event is a potential Serious Event, Sentinel Event, Infrastructure Failure, Medication Event or Incident. D. Investigations and Analyses of Reportable Patient Events by applicable Facility Committee. Each facility s policy shall establish a procedure whereby: 1. The Committee shall receive notice of any Reportable Patient Event determined at any time to be a Serious Event, Sentinel Event or Infrastructure Failure, and the reports of further investigation and/or analysis including root cause analysis shall always be conducted of any event designated as a Sentinel Event or potential Sentinel Event ( near miss ). 2. All root cause, intensive and other analyses shall be carried out as confidential peer review activities (by a duly authorized peer review committee) in accordance with the requirements of state and federal law and TJC and other controlling regulatory bodies. Generally, any analysis shall seek to determine or establish all or some of the following, as the facts may dictate: a. the special cause of the adverse event; b. any common cause (Hospital process, procedure, policy, facility, system or personnel) deemed to have contributed in any significant way to the event; c. possible changes involving any common cause that might avoid or lessen the chances of the adverse event reoccurring; d. proposed corrective action plan(s) to implement possible changes involving common cause(s). E. Further Actions by the Committee. Each facility s policy shall establish procedures whereby: 1. The Committee shall review and act upon the results of any analyses, including overseeing the implementation of any Corrective Action plans. 2. Any designated Incident or Infrastructure Failure shall be immediately referred to the Patient Safety Officer for reporting to the appropriate regulatory body. For any designated Sentinel Event, the Patient Safety Officer shall make a determination whether and how to report to TJC and/or the Department of Health and/or the Authority after consultation with legal counsel and the Chief Quality Officer or designees.
PAGE 7 F. Outside Reporting to Regulatory/Accreditation Bodies. Each facility s policy shall establish procedures whereby: 1. As soon as possible after receipt of knowledge that an event has been determined to be a Serious Event, but no later than twenty-four (24) hours, the Patient Safety Officer or designee shall make a report of the Serious Event to the DOH and to the Patient Safety Authority in accordance with MCARE and applicable regulations of the DOH and/or the Patient Safety Authority. The report shall not include the name or other identifiable individual information. 2. As soon as possible after receipt of knowledge that an event has been determined to be an Infrastructure Failure, but no later than twenty-four (24) hours, the Patient Safety Officer or designee shall make a report of the Infrastructure Failure to the DOH and/or the Authority in accordance with MCARE and applicable regulations of the DOH. The report shall not include the name or other identifiable individual information. 3. As soon as possible after a determination (after consultation with the Chief Quality Officer and appropriate legal counsel) that a Sentinel Event will be reported to TJC, such report shall be made within the time frame and in the manner prescribed by TJC. 4. The Patient Safety Officer or designee shall report identified Incidents to the Authority in accordance with MCARE and applicable regulations of the Authority. G. Role of the MCARE Patient Safety Committee. Refer to Patient Safety Plans. Each facility s policy shall provide that: 1. The Patient Safety Officer shall prepare for presentation to the MCARE Patient Safety Committee at its regular meetings all or selected portions of the IIER s that represent reports of Serious Events and Incidents. The Patient Safety Officer may also present to the Committee reports that summarize aggregate data extracted from the IIER s concerning Serious Events and Incidents or other summary or analytical reports concerning Incidents and Serious Events. 2. The Patient Safety Officer shall prepare for presentation to the MCARE Patient Safety Committee reports regarding investigations and analyses of Serious Events and Incidents conducted by the Patient Safety Officer or his/her designees.
PAGE 8 3. The Patient Safety Officer shall prepare for presentation to the MCARE Patient Safety Committee and/or the Committee reports of any proposed or implemented corrective actions. 4. All reports prepared by the Patient Safety Officer for the MCARE Patient Safety Committee or the Committee are privileged and confidential and shall be prepared exclusively for members of those Committees and shall not be shown to any other person or used for any other purpose. 5. Any recommendations made by the MCARE Patient Safety Committee to eliminate future Serious Events or Incidents shall be referred to the Committee through the Patient Safety Officer and shall be included in the quarterly report made by the Patient Safety Officer on behalf of the MCARE Patient Safety Committee and /or the Committee to the facility s Chief Executive Officer and governing Board (or designated subcommittee of the Board). H. Confidentiality and Peer Review Protection. Each facility s policy shall provide that: 1. All actions and internal oral and written communications, of any type, created by or for any person, committee, department or body in furtherance of the facility s patient safety policy or the facility s patient grievance policy shall be kept strictly confidential and considered as protected by federal laws and the Pennsylvania Peer Review Protection Act and/or the MCARE Act. All internal written communications related to a matter covered by this policy, including emails, shall be prominently labeled Confidential Peer Review Protected Material. 2. No person, committee, department or body shall disseminate any information or written communication created as a result of the procedures set forth in any relevant facility policy or the facility s Patient Safety Plan to any person or entity (internal or external) other than a person or entity who or which is part of the peer review process with a specific and legitimate need to obtain and use such information. 3. Questions concerning the release of peer review protected information, or the creation of any reports or documents that may be entitled to peer review protection, should be directed to legal counsel. VI. POLICIES REFERENCED WITHIN THIS POLICY HS-PT1204 HS-RI1305 Preventable Serious Adverse Events Initial Incident/Event Reporting
PAGE 9 SIGNED: Richard P. Kidwell Senior Associate Counsel/Vice President of Risk Management ORIGINAL: June 16, 2003 APPROVALS: Policy Review Subcommittee: November 12, 2015 Executive Staff: December 4, 2015 PRECEDE: December 1, 2014 SPONSOR: Senior Associate Counsel/Vice President of Risk Management