POLICY/PROCEDURE PLAN GUIDELINE. SECTION: I Administrative

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1 TITLE: Patient Safety Occurrence Report POLICY PTCADM SCOPE: Children's Hospital of Pittsburgh ("CHP") Main Children's Hospital of Pittsburgh Satellites Children's Hospital of Pittsburgh Ambulatory Clinics Children s Hospital of Pittsburgh Ancillary Service CHP North Surgery Center ORIGINATION DATE: 07/01/1991 I. POLICY: REVIEW/REVISION DATE: 12/1996, 11/2000, 02/2001, 06/2001, 01/2002, 03/2003, 11/2005, 03/2007, 04/2008, 05/2009, 10,2010, 09/2012, 07/2013, 08/2013; 06/2015 POLICY/PROCEDURE PLAN GUIDELINE SECTION: I Administrative Approval Committee Informational Review Medical Executive Committee Patient Care Leadership Practice Council Executive Management Group Approval Committee Final Approval Medical Executive Committee Patient Care Leadership Practice Council Patient Safety Oversight Committee Executive Management Group Department Approval Only It is the policy of Children s Hospital of Pittsburgh of UPMC (CHP) to provide a mechanism for hospital employees/physicians to report occurrences that may involve medical errors, bodily injuries, adverse drug events, unanticipated occurrences or outcomes, events that may impact patient safety, delays or potential delays in treatment/diagnosis or administrative errors. This reporting process is initiated with the filing of a Patient Safety Occurrence Report (PSOR) through direct entry into the Riskmaster reporting system or verbal notification to the Patient Safety Staff II. DEFINITION: A patient safety occurrence is defined as any happening which is not consistent with the routine care of a particular patient 1. The event includes, but is not solely limited to: (1) any potential or actual error, (2) any unusual or unexpected result of treatment, (3) any event that is inconsistent with the routine operation of the hospital or care of a patient, or (4) any irregular or improper deviation from standard procedure. Other Definitions: Incident: As defined by Mcare: 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. IIER: Initial Incident/Event Report abbreviation used to identify and report Reportable Patient Events and Other Reportable Events as they appear in the Supervisor diaries in Risk Master. Infrastructure: Structures related to the physical plant and service delivery systems necessary for the provision of health care services in a medical facility. Infrastructure Failure: As defined by Mcare: 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. Mcare: Pennsylvania s Medical Care Availability and Reduction of Error Act. Medication Event: Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer. Such events may be related to professional practice, health care products, procedures and systems, including prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing, distribution, administration, education, monitoring or use.

2 Page 2 of 6 Never Events: According to the National Quality Forum (NQF), never events are errors in medical care that are clearly identifiable, preventable ad serious in their consequences for patients, and that indicate a real problem in the safety and credibility of a health care facility. Preventable Serious Adverse Event (PSAE): an event that occurs in a health care facility that is within the health care provider s control to avoid, but that occurs because of an error or other system failure and results in a patient s death, loss of body part, disfigurement, disability or loss of bodily function lasting more than seven days or still present at the time of discharge from a health care facility. (See system policy HS-PT1204 for details.) Reportable Patient Event: Any Incident, Medication Event, Never Event, Sentinel Event, Serious Event or Infrastructure Failure. Reportable Staff Event: Any injury, illness, or infectious disease exposure that results as a consequence of a UPMC employee s job related duties. These are to be reported directly to UPMC Work Partners. (See system policy HSHR0730 for details.) Other Reportable Event: Any unexpected event or disruption of normal routine not involving the clinical care of a patient (i.e. environmental health and safety issues, missing, damaged or stolen hospital or patient/visitor property, visitor injury) Patient Safety Officer: The person designated to carry out the obligations and functions of Patient Safety Officer as defined in Mcare. Peer Review Committee: A committee consisting of health care providers and/or hospital administrators 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 standards set by an association of health care providers and with applicable laws, rules and regulations. PSOR: The Patient Safety Occurrence Report form is a peer review protected document. The PSOR has been replaced by direct entry into the RiskMaster reporting system. In the event that a form is utilized, it should be forwarded to the Quality Services Department immediately. Reporters: Staff members, physicians, employees, volunteers, students, or other persons who gain knowledge of a Reportable Patient Event, Reportable Staff Event or Other Reportable Event. Sentinel Event: An Incident or Serious Event defined by The Joint Commission as 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 following specific events are always considered Sentinel Events: infant abduction, infant discharge to the wrong family, unanticipated death of a full born infant, rape (by another patient or staff), hemolytic transfusion reaction, surgery on the wrong patient or wrong body part, suicide of a patient in a setting where the patient receives round-the clock care, health care acquired infections associated with unanticipated death or major permanent loss of function, unintended retention of a foreign object in an individual after surgery or other procedure,severe neonatal hyperbilirubinemia greater than 30 mg/dl, prolonged fluoroscopy with cumulative dose greater than 1500 rads to a single field or any delivered radiotherapy to the wrong body region or greater than 25% above the planned radiotherapy dose and tubing misconnections.

3 Page 3 of 6 Serious Event: As defined by Mcare: 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. III. PURPOSE: The purpose for immediate and mandatory verbal notification regarding a patient safety occurrence is to determine if the event is a reportable event as defined by the Pennsylvania Department of Health and to comply with the CHP Patient Safety Plan. The purpose of completing direct entry into RiskMaster IIER is to record the occurrence. All reported events are reviewed by the Patient Safety Specialists to determine if further investigation or review by Patient Safety Officer is necessary as part of a continuing Peer Review Process. Data provided by the occurrences reported through RiskMaster/PA-PSRS is used to identify trends, pinpoint systems or process issues, help assess the need for policy or procedural changes, identify areas in need of facility repairs and to help highlight changes needed in educational programs, any or all of which will improve the quality, safety and/or efficiency of patient care. IV. PROCEDURE: PROCEDURE FOR REPORTING A PATIENT SAFETY OCCURRENCE: Upon discovery of a patient safety occurrence, patient care and safety is the overall first priority. It shall be reported to the Patient Safety Officer, Coordinator, Specialist or the Administrator on Duty no later than 24 hours after the discovery. A brief description of the occurrence or the event, any actual or potential injury to the patient, any immediate treatment rendered or ordered and any follow-up that is necessary shall be documented in the RiskMaster entry. The Unit Director or Administrator on Duty will contact the Patient Safety Officer or Specialists on call. The Patient Safety Officer and /or Specialists are available 24/7 and can be reached through the hospital operator. After discussion with the Patient Safety Officer and/or Vice President of Medical Affairs and/or the Chief Nursing Officer, a decision will be made whether the event is a reportable event. The Patient Safety Officer or Specialists or the Administrator on Duty will then report the event to the Patient Safety Authority/Department of Health in accordance with their procedures. All related documentation shall be hand-delivered to Patient Safety in the Quality Services Department. No copies of these reports are permitted to be maintained. In the event of an infrastructure incident, the appropriate facilities manager or designee, as well as Patient safety staff, are to be contacted. A discussion will take place to determine whether the event is reportable to the DOH or not.

4 Page 4 of 6 PROCEDURE FOR COMPLETING THE PATIENT SAFETY OCCURRENCE REPORT (PSOR): After care is rendered to the patient, the event should be entered into The report should include: 1) Identification of the patient involved in the occurrence. 2) Medical record number of the patient. 3) Diagnosis/principle procedure and the condition for which the patient was being treated. 4) Date, time and location of the occurrence. 5) Brief, factual description of the occurrence. 6) Identity of any witnesses to the occurrence. (This may include other staff, roommates or visitors.) 7) If applicable, any injuries to the patient. 8) Any specific complaint by the patient or others on behalf of the patient. 9) If applicable, date, time and name of physician who was notified. 10) If applicable, the name of the examining physician and date and time of any examination. The Reporter should only provide the minimum amount of facts known by the Reporter to accurately describe the event. The Reporter should not include conclusions, opinions, conjectures or extraneous information. Further details involving the event can be provided through subsequent investigations by a Peer Review Organization, the Patient Safety staff or others. Physician Notification. The attending physician and/or other physician(s) involved in the care of the patient should be notified of any Reportable Patient Event that has or could affect clinical care. The patient s medical record and PSOR/Risk Master should indicate notification of the physician(s). Documentation in Patient Record. The relevant clinical facts surrounding the Patient Event should be recorded in the patient s medical record. Conclusions, conjectures, administrative grievances or other extraneous matters should not be noted. Reports to Supervisors. A Reporter should notify his or her immediate supervisor about the Reportable Patient Event as soon as practical. No Retaliation for Reporting. No Reporter shall be discharged, demoted or otherwise discriminated or retaliated against regarding his or her compensation, terms, conditions, location or privileges of employment solely for reporting in good faith a Serious Event or Incident. However, a Reporter may be subject to disciplinary or corrective action for knowingly making a false report. Consequences of Not Reporting Serious Events. Under Pennsylvania law, the Hospital has an obligation to notify the appropriate State licensing board if a licensed health care provider providing services in the Hospital fails to report a Serious Event in accordance with this policy. An employee who knowingly fails to report a Serious Event may be subject to disciplinary or corrective action. Confidentiality. The facts and circumstances surrounding a reportable Patient Event should be kept confidential and only discussed with 1) other health care providers with a need to know for treatment purposes, 2) the Reporter s supervisor, and 3) internal members or representatives investigating the event (specifically legal counsel, VPMA, CNO, PSO, or PSS). No written documents concerning the event should be created by the Reporter other than the IIER unless requested by or on behalf of the representative investigating the event.

5 Page 5 of 6 Any staff member with factual information about an event can enter the information into RiskMaster. Staff may verbally report an occurrence to the confidential Quality Care Line (ext 4999) and then shall follow-up with RiskMaster entry. The physician should include his/her assessment of the patient and a description of any treatment rendered as a result of the specific occurrence. If further follow-up is necessary, this should be indicated as well. The manager receives an automatic notification via that an event has been entered. After the event is reviewed by the Patient Safety Specialist, the manager may receive a request for additional follow-up via RiskMaster diary notification. Follow-up can be entered directly into the RiskMaster system. A summary of the events are then reviewed by the Clinical Quality Oversight Committee (CQOC) and the Patient Safety Oversight Committee (PSOC.) If the event is deemed significant or sentinel, the Process for Analyzing Significant Serious and/or Sentinel Event Policy (#100.41) is then evoked. CONFIDENTIALITY: The PSOR is a confidential internal peer review document. The original paper PSOR or Risk Master entry: Must not be copied or printed. Is not part of the medical record. Must not be included or referred to in the patient s chart; however, the facts surrounding an occurrence that are necessary for patient care should be noted separately in the record. Must not be given to patients, their families or their representatives. Unauthorized use or copying of PSOR or printing from RiskMaster can be grounds for disciplinary action. Events Involving Medical Devices and Disposable Equipment 1. Immediate Report to Patient Safety Specialist. If a medical device or piece of equipment is suspected of contributing to or causing serious illness or injury to or death of a patient or staff member, the event should be immediately reported to a Patient Safety Specialist or to the Patient Safety Officer on call, via phone. The Patient Safety Specialist or Officer shall report the event to Legal Services when it involves patient injury. a) Equipment should be removed from service, tagged and should not be repaired or altered until authorized by the Patient Safety Staff of the Quality Services Department. b) b. For equipment capable of storing information in memory, the information should be printed out in hard copy before turning the equipment off or doing anything that could lose or erase the data. All reasonable efforts should be taken to preserve all stored data. 2. Recovery and Preservation of Disposables. All efforts should be made to recover and save disposable equipment. Appropriate biohazard packaging should be used when indicated. 3. Use of Product Issue Notification Form. This form, which is linked below to this policy, is to be completed when there is a known issue/problem with a product. This is a 3 page form. The first page is to be completed by the person that identified the problem. It is then to be sent to the Manager, Materials Management, along with the packaging and product Page 2 is to be

6 Page 6 of 6 completed by Materials Management. Upon completion of this page, it then is to be sent to the Value Analysis Program Manager for completion of page 3 and maintenance in their file. They are also to enter this into their Product Issues Notification log. REPORTING OF OCCURRENCES/CONCERNS BY PATIENT AND/OR FAMILY Patients and/or family members can report occurrences/concerns per the following: Contact the Patient Representatives office ( ) Call the Quality Care Line ( ) ANONYMOUS REPORTING OF SERIOUS EVENTS TO THE PATIENT SAFETY AUTHORITY: Act 13 requires all Pennsylvania-licensed hospitals, birthing centers and ambulatory surgical facilities to report "serious events" and "incidents" to the Patient Safety Authority. An important component of Act 13 is the ability of healthcare workers to submit an Anonymous report to the Patient Safety Authority of a "serious event". The definition of a "serious event" 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. Anonymous reporting applies only to "serious events". The healthcare worker must have first reported the "serious event" through CHP of UPMC s reporting process (i.e. enter into RiskMaster, notify a Patient Safety Specialist, or call the Quality Care Line). Whistle Blower Protection applies to anonymous reporting. The Serious Event Anonymous Report Form can be found by accessing the following website and clicking on the Anonymous Report link The form includes instructions for completing the report as well as the mailing address and fax number for submitting the form. Only CHP of UPMC and CHP of UPMC North employees/physicians shall conduct peer review relating to the patient occurrence. If an employee or physician is contacted by anyone else concerning an event, please call the Quality Department. Any questions regarding this policy should be directed to the Quality Services Department. FORMS RELEVANT TO THIS POLICY Form # TBD Name of Form Product Issue Notification Form OTHER POLICIES RELEVANT TO THIS POLICY Policy # Name of Policy Patient Safety Plan Process for Analyzing Significant Serious and/or Sentinel Events