Clinical Interdepartmental Policy and Procedure

Size: px
Start display at page:

Download "Clinical Interdepartmental Policy and Procedure"

Transcription

1 Clinical Interdepartmental Policy and Procedure Policy: Staff Response to Medical Errors/Adverse Events Policy Number: MR-006 Joseph S. Gordy, CEO Signature: Flagler Hospital Originator: President Coordinating Departments: All Departments Original Issue Date: May 13, 2002 Current Revision Date: 5/14/04 10/27/05 6/9/06 1/8/15 Last Review Date: Chapter: Regulatory References: Other References: Medical Error Reporting 2655Page 1 of 5 Flagler Hospital 400 Health Park Blvd. St. Augustine, Fl

2 POLICY: STAFF RESPONSE TO MEDICAL ERRORS/ ADVERSE EVENTS OBJECTIVE: It is a policy of this hospital to establish a procedure for the immediate response to medical/health care errors, including care of the affected patient, containment of risk to others, and preservation of factual information for subsequent analysis. RESPONSE TO ERROR Upon identification of a medical/health care error, the patient care provider will immediately: 1. Perform necessary healthcare interventions to protect and support the patient's clinical condition. 2. As appropriate to the occurrence, perform necessary healthcare interventions to contain the risk to others - example: immediate removal of contaminated IV fluids from floor stock should it be discovered a contaminated lot of fluid solutions was delivered and stocked. Also, immediately remove from service any malfunctioning equipment that was involved in a medical error refer to the P&P on Defective Equipment. P&P - DEFECTIVE EQUIPMENT JAN 2015 EOC Contact the patient's attending physician and other physicians, as appropriate, to report the error, carrying out any physician orders as necessary. 4. Preserve any information related to the error (including physical information). Examples of preservation of physical information are: Removal and preservation of blood unit for a suspected transfusion reaction; preservation of IV tubing, fluids bags and/or pumps for a patient with a severe drug reaction from IV medication; preservation of medication label for medications administered to the incorrect patient. Preservation of information includes documenting the facts regarding the error on an incident report, and in the medical record as appropriate to organizational policy and procedure. 5. Report the medical/health care error to the staff member's immediate supervisor. 6. Submit the incident report to the Risk Manager per organizational policy. 7. The physician or his designee shall be responsible for informing the patient of the error, the potential or actual impact of the error on his or her physical and/or psychological condition, and the subsequent care that will be provided. (See policy on Disclosure of Medical Errors). P&P - DISCLOSURE OF MEDICAL ERRORS JAN 2015 MR Any individual in any department identifying a potential patient safety issue will immediately notify his or her supervisor and submit an incident report within 72 hours via RL Solutions to the Risk Manager Page 2 of 5

3 9. Staff response to medical/health care errors is dependent upon the severity of the error identified: SEVERITY LEVELS: v Near Miss Errors: o Definition: Circumstances or events that have the capacity to cause error or an error occurred but the error did not reach the patient. o Reporting Tool: Staff should make every effort to report near miss errors in RL Solutions. If a more anonymous approach is necessary, then the error can be reported via the red box anonymous reporting system, or the F.H. Intranet giving the circumstances of the event. o Notification: The staff member may have the option of reporting this error to a supervisor; however, in the interest of patient safety, near misses should be quickly identified and addressed to prevent an actual error from occurring. v No Harm Errors: o Definition: These are errors that reached the patient but did not cause patient harm and may or may not have resulted in the need for increased patient monitoring. o Reporting Tool: A No Harm Error should be reported via incident report (within 72 hours of the event) in RL Solutions. These types of errors could include a medication error or patient fall where no injury to the patient was sustained. v Mild Adverse Outcome Errors: o Definition: Error that resulted in the need for treatment or intervention and caused temporary patient harm. o Reporting Tool: A Mild Adverse Outcome Error should be reported via incident v Moderate Adverse Outcome Errors: o Definition: An error occurred that resulted in initial or prolonged hospitalization and caused temporary patient harm. o Reporting Tool: A Moderate Adverse Outcome Error should be reported via incident 2655 Page 3 of 5

4 v Severe Adverse Outcome Errors: o Definition: An error that resulted in permanent patient harm, a near death event (anaphylaxis, cardiac arrest), or patient death. o Reporting Tool: A Severe Adverse Outcome Error should be reported via incident The staff member should also immediately notify the Risk Manager (within 24 hours) or the administrator on call. RESPONSE TO ADVERSE EVENTS 1. The following are categories of incidents that should be reported to Leadership through the following reporting mechanisms: TYPES OF INCIDENTS v Adverse Clinical Event: o Definition: an injury related to medical care may or may not be due to error. o Reporting Tool: Incident Report - Staff shall report these events via an incident report (RL Solutions) submitting the report to the Risk Manager per organizational policy. v Medication Error: o Definition: Inappropriate processes in drug therapy that may cause adverse drug events. These processes include errors in prescribing, distribution, and administration. o Reporting Tool: Incident Report submitted within 72 hrs via RL Solutions. v Patient Falls: o Definition: A fall is a loss of upright position that results in landing on the floor, ground or object of furniture or sudden uncontrolled, unintentional, non-purposeful, downward displacement of the body to the floor, stairs, etc. It includes an unwitnessed fall, a near fall, or an assisted fall. o Reporting Tool: Incident Report submitted within 72 hrs via RL Solutions. v Adverse Drug Reaction: o Definition: An untoward drug effect that occurs during normal and correct medical care, not related to an error. o Reporting Tool: Incident Report submitted within 72 hrs via RL Solutions or to pharmacy director the chart #, date of reaction, drug name and reaction noted; or, call the Pharmacy, or notify via the FH Intranet. v Transfusion Reaction: o Definition: An untoward blood transfusion effect that occurs during normal and correct medical care, not related to an error. o Reporting Tool: Transfusion Reaction Form. If reaction was due to an ERROR, then must ALSO complete an incident report and submit to the Risk Manager per organizational policy. o Notification: Notify the attending physician Page 4 of 5

5 v Hazardous Condition/Patient Safety Issue o Definition: any set of circumstances, exclusive of the disease or condition for which the patient is being treated, which significantly increases the likelihood of a serious physical or psychological adverse patient outcome. o Reporting Tool: Complete an Incident Report submitting the report to the Risk Manager per organizational policy. o Notification: The staff member shall notify his/her immediate supervisor. Consider notifying the Safety Director. o Containment: as appropriate, and if possible, staff will contain the hazardous condition or patient safety issue Page 5 of 5

CRAIG HOSPITAL POLICY/PROCEDURE. Revised Date: 06/03, 3/05; 06/05; A Incident Flow Chart

CRAIG HOSPITAL POLICY/PROCEDURE. Revised Date: 06/03, 3/05; 06/05; A Incident Flow Chart CRAIG HOSPITAL POLICY/PROCEDURE Approved: DD 11/06; SC, CIC, MEC, P&P Effective Date: 04/84 1/07; CC, P&P 6/07; 05/10; DD, MEC 09/11 P&P 10/11, 09/12; EOC 06/13, P&P 07/13; 10/14, 07/16 Attachments: Revised

More information

CRAIG HOSPITAL POLICY/PROCEDURE INCIDENT REPORTS AND REPORTING TO THE COLORADO DEPARTMENT OF HEALTH

CRAIG HOSPITAL POLICY/PROCEDURE INCIDENT REPORTS AND REPORTING TO THE COLORADO DEPARTMENT OF HEALTH CRAIG HOSPITAL POLICY/PROCEDURE Approved: DD 11/06; SC, CIC, MEC, P&P Effective Date: 04/84 1/07; CC, P&P 6/07; 05/10; DD, MEC 09/11 P&P 10/11, 09/12 Attachments: A Incident Flow Chart Revised Date: 06/03,

More information

National Health Regulatory Authority Kingdom of Bahrain

National Health Regulatory Authority Kingdom of Bahrain National Health Regulatory Authority Kingdom of Bahrain THE NHRA GUIDANCE ON SERIOUS ADVERSE EVENT MANAGEMENT AND REPORTING THE PURPOSE OF THIS DOCUMENT IS TO OUTLINE SERIOUS ADVERSE EVENTS THAT SHOULD

More information

BAY-ARENAC BEHAVIORAL HEALTH AUTHORITY POLICIES AND PROCEDURES MANUAL

BAY-ARENAC BEHAVIORAL HEALTH AUTHORITY POLICIES AND PROCEDURES MANUAL Page: 1 of 14 Policy It is the policy of Bay-Arenac Behavioral Health Authority (BABHA) that all adverse events, such as unusual events (including risk), critical incidents (including all deaths) and sentinel

More information

POLICY NAME POLICY # Sentinel, Adverse Event and Near Miss. CSP Reporting and Investigation

POLICY NAME POLICY # Sentinel, Adverse Event and Near Miss. CSP Reporting and Investigation Purpose To outline a reporting system that promotes client safety by learning from experiences and utilizing the results of investigations and data analysis to prepare and disseminate recommendations for

More information

POLICY/PROCEDURE PLAN GUIDELINE. SECTION: I Administrative

POLICY/PROCEDURE PLAN GUIDELINE. SECTION: I Administrative TITLE: Patient Safety Occurrence Report POLICY PTCADM100.23 SCOPE: Children's Hospital of Pittsburgh ("CHP") Main Children's Hospital of Pittsburgh Satellites Children's Hospital of Pittsburgh Ambulatory

More information

NOTE: The first appearance of terms in bold in the body of this document (except titles) are defined terms please refer to the Definitions section.

NOTE: The first appearance of terms in bold in the body of this document (except titles) are defined terms please refer to the Definitions section. TITLE IMMEDIATE MANAGEMENT OF CLINICAL ADVERSE EVENTS SCOPE Provincial APPROVAL AUTHORITY Quality Safety and Outcomes Improvement Executive Committee SPONSOR Quality and Healthcare Improvement PARENT DOCUMENT

More information

HAEMOVIGILANCE POLICY

HAEMOVIGILANCE POLICY REASON FOR ISSUE: New document describing Haemovigilance System 1. INTRODUCTION NZBS has adopted the Council of Europe definition that states that haemovigilance is: The organised surveillance procedures

More information

Walking the Tightrope with a Safety Net Blood Transfusion Process FMEA

Walking the Tightrope with a Safety Net Blood Transfusion Process FMEA Walking the Tightrope with a Safety Net Blood Transfusion Process FMEA AnMed Health AnMed Health, located in Anderson, South Carolina, is one of the largest and most technologically advanced health systems

More information

PHARMACY SERVICES/MEDICATION USE

PHARMACY SERVICES/MEDICATION USE 25.01. 10 Drug Reactions & Administration Errors & Incompatibilities. Drug administration errors, adverse drug reactions and incompatibilities must be immediately reported to the attending physician and

More information

1. PURPOSE 2. SCOPE 3. RESPONSIBILITIES

1. PURPOSE 2. SCOPE 3. RESPONSIBILITIES 1. PURPOSE The purpose of this standard operating procedure (SOP) is to inform all Alexion personnel, and applicable service providers who become aware of a Pharmacovigilance (PV) Event of their responsibility

More information

Improving the reporting of medication-related safety incidents

Improving the reporting of medication-related safety incidents Rationale Improving the reporting of medication-related safety incidents Research shows that organisations which regularly report more patient safety incidents usually have a stronger learning culture

More information

3/9/2010. Objectives. Pharmacist Role in Medication Safety and Regulatory Compliance

3/9/2010. Objectives. Pharmacist Role in Medication Safety and Regulatory Compliance Pharmacist Role in Medication Safety and Regulatory Compliance Janet Greiwe Vice President, Systems Management Cleveland County Health System Objectives By the end of this presentation, you should be able

More information

Infusion Therapy Learning Exercise: Infusion Documentation

Infusion Therapy Learning Exercise: Infusion Documentation Infusion Therapy Learning Exercise: Infusion Documentation INFUSION OF DOCUMENT IN DOCUMENT PERIPHERAL PICC LINE BLOOD TRANSFUSION SPINAL EPIDURAL CLPNA Infusion Therapy: Infusion Documentation Exercise

More information

Biomedical IRB MS #

Biomedical IRB MS # Department for Human Research Protections Institutional Review Boards Biomedical IRB MS # 1035 419-383-6796 IRB.Biomed@utoledo.edu Social, Behavioral and Educational IRB MS # 944 419-530-6167 IRB.SBE@utoledo.edu

More information

Drug Events. Adverse R EDUCING MEDICATION ERRORS. Survey Adapted from Information Developed by HealthInsight, 2000.

Drug Events. Adverse R EDUCING MEDICATION ERRORS. Survey Adapted from Information Developed by HealthInsight, 2000. Survey Adapted from Information Developed by HealthInsight, 2000. Adverse Drug Events R EDUCING MEDICATION ERRORS The Adverse Drug Events Survey will assist healthcare organizations evaluate the number

More information

Preventing Medical Errors

Preventing Medical Errors Presents Preventing Medical Errors Contact Hours: 2 First Published: March 31, 2017 This Course Expires on: March 31, 2019 Course Objectives Upon completion of this course, the nurse will be able to: 1.

More information

Ensuring our safeguarding arrangements act to help and protect adults PRACTICE GUIDANCE FOR REPORTING MEDICATION INCIDENTS INTO SAFEGUARDING

Ensuring our safeguarding arrangements act to help and protect adults PRACTICE GUIDANCE FOR REPORTING MEDICATION INCIDENTS INTO SAFEGUARDING Ensuring our safeguarding arrangements act to help and protect adults PRACTICE GUIDANCE FOR REPORTING MEDICATION INCIDENTS INTO SAFEGUARDING Contents Page 1.0 Purpose 2 2.0 Definition of medication error

More information

ED0028 Adverse event, critical incident, serious issue, and near miss procedure

ED0028 Adverse event, critical incident, serious issue, and near miss procedure ED0028 Adverse event, critical incident, serious issue, and near miss procedure 1. Full description Adverse event, critical incident, serious issue, 2. Preamble Doctors working in Australia have responsibilities

More information

PRIVACY BREACH MANAGEMENT GUIDELINES. Ministry of Justice Access and Privacy Branch

PRIVACY BREACH MANAGEMENT GUIDELINES. Ministry of Justice Access and Privacy Branch Ministry of Justice Access and Privacy Branch December 2015 Table of Contents December 2015 What is a privacy breach? 3 Preventing privacy breaches 3 Responding to privacy breaches 4 Step 1 Contain the

More information

Thanks to Anne C. Byrne, RN, Medical Monitor at Northwest Georgia Regional Hospital. This presentation was developed from one she designed for that

Thanks to Anne C. Byrne, RN, Medical Monitor at Northwest Georgia Regional Hospital. This presentation was developed from one she designed for that Thanks to Anne C. Byrne, RN, Medical Monitor at Northwest Georgia Regional Hospital. This presentation was developed from one she designed for that hospital. 1 2 3 Note that an actual variance occurs when

More information

POL:08:LP:003:03:NIBT PAGE : 1 of 5. Document Title: NIBTS POLICY FOR RETURN AND RE-ISSUE OF BLOOD AND BLOOD COMPONENTS

POL:08:LP:003:03:NIBT PAGE : 1 of 5. Document Title: NIBTS POLICY FOR RETURN AND RE-ISSUE OF BLOOD AND BLOOD COMPONENTS POL:08:LP:003:03:NIBT PAGE : 1 of 5 Northern Ireland Blood Transfusion Service POLICY DOCUMENT Document Details Document Number: POL:08:LP:003:03:NIBT Supersedes Number: 08:02:LP:003:NIBT No. of Appendices:

More information

TITLE: Reporting Adverse Events SOP #: RCO-204 Page: 1 of 5 Effective Date: 01/31/18

TITLE: Reporting Adverse Events SOP #: RCO-204 Page: 1 of 5 Effective Date: 01/31/18 SOP #: RCO-204 Page: 1 of 5 1. POLICY STATEMENT: The research team is responsible for recognizing changes in subject health that may qualify as adverse events, classifying those results as defined in the

More information

Guide to Incident Reporting for In-vitro Diagnostic Medical Devices

Guide to Incident Reporting for In-vitro Diagnostic Medical Devices Guide to Incident Reporting for In-vitro Diagnostic Medical Devices SUR-G0004-4 02 AUGUST 2012 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes

More information

WHAT are medication errors?

WHAT are medication errors? Healthcare Case Study: Errors Cause Mapping Problem Solving Incident Investigation Root Cause Analysis Errors Angela Griffith, P.E. webinars@thinkreliability.com www.thinkreliability.com Office 281-412-7766

More information

MAIMONIDES MEDICAL CENTER. SUBJECT: Medical Equipment Failures and Medical Device Reporting Program

MAIMONIDES MEDICAL CENTER. SUBJECT: Medical Equipment Failures and Medical Device Reporting Program MAIMONIDES MEDICAL CENTER CODE: AD-101 (Reissued) DATE: May 7, 2013 ORIGINALLY ISSUED: 4/19/1993 SUBJECT: Medical Equipment Failures and Medical Device Reporting Program I POLICY: It is the policy of Maimonides

More information

GENERAL ADMINISTRATIVE POLICY: ADVERSE EVENT REPORTING TO CALIFORNIA DEPARTMENT OF PUBLIC HEALTH (CDPH)

GENERAL ADMINISTRATIVE POLICY: ADVERSE EVENT REPORTING TO CALIFORNIA DEPARTMENT OF PUBLIC HEALTH (CDPH) GENERAL ADMINISTRATIVE POLICY: ADVERSE EVENT REPORTING TO CALIFORNIA DEPARTMENT OF PUBLIC HEALTH (CDPH) Effective Date: 02/12 Page No. 1 of 7 I. PURPOSE To comply with mandated reporting requirements of

More information

Human Samples in Research

Human Samples in Research Human Samples in Research Adverse Event Reporting Document Identifier HTA-11-SOP-Adverse Event Reporting AUTHOR APPROVER EFFECTIVE DATE: Name and role Signature and date Name and role Signature and date

More information

ACCOUNTABILITY: OBJECTIVES: RELATION TO MISSION: RELATION TO OPERATION: POLICY: Chief Nursing Officer

ACCOUNTABILITY: OBJECTIVES: RELATION TO MISSION: RELATION TO OPERATION: POLICY: Chief Nursing Officer Our Lady of Lourdes Health Care Services, Inc. and Affiliates including Our Lady of Lourdes Medical Center Lourdes Medical Center of Burlington County Administrative and General Policy Page number: 1 of

More information

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Safety Reporting in CTIMPs and ATMPs SOP number: TM 003 SOP category: Trial Management Version number: 03 Version date:

More information

2016 Annual Associate Safety Modules Section 7 Safe Medical Devices Act (SMDA)

2016 Annual Associate Safety Modules Section 7 Safe Medical Devices Act (SMDA) 2016 Annual Associate Safety Modules Section 7 Safe Medical Devices Act (SMDA) Reporting Defective Medical Devices WHAT IS S.M.D.A The Safe Medical Devices Act (SMDA) is a federal act designed to assure

More information

I. GENERAL INFORMATION

I. GENERAL INFORMATION I. GENERAL INFORMATION Our Mission Statement To provide quality healthcare and foster health and wellness. Our Vision Statement Vision Statement: Our Desired Future To be the preferred provider for high

More information

A Primer on Patient Safety Events Winnipeg Regional Health Authority November 2014

A Primer on Patient Safety Events Winnipeg Regional Health Authority November 2014 A Primer on Patient Safety Events Winnipeg Regional Health Authority November 2014 TABLE OF CONTENTS Each Patient Safety Event listed below includes a definition, procedures for reporting, information

More information

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Safety Reporting in CTIMPs and ATMPs SOP number: TM-003 SOP category: Trial Management Version number: 04 Version date:

More information

Blood Transfusion Policy. Version Number: 6.1 Controlled Document Sponsor: Controlled Document Lead: On: December 2014.

Blood Transfusion Policy. Version Number: 6.1 Controlled Document Sponsor: Controlled Document Lead: On: December 2014. Blood Transfusion Policy CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Policy Clinical The policy describes the framework and principles required to deliver best transfusion

More information

CHAPTER 9 PERFORMANCE IMPROVEMENT HOSPITAL

CHAPTER 9 PERFORMANCE IMPROVEMENT HOSPITAL CHAPTER 9 PERFORMANCE IMPROVEMENT HOSPITAL PERFORMANCE IMPROVEMENT Introduction to terminology and requirements Performance Improvement Required (Board of Pharmacy CQI program, The Joint Commission, CMS

More information

Medication Reconciliation with Pharmacy Technicians

Medication Reconciliation with Pharmacy Technicians Technician Education Day March 29, 2014 Jacksonville, FL Outline with Pharmacy Technicians Roma Merrick RPhT., CPhT. Pharmacy Technician Coordinator St. Vincent s Medical Center Southside Jacksonville,

More information

Board Approved: 01/05/ /08/ /01/15 01/16/15 Responsible Party: Director of Compliance/QA

Board Approved: 01/05/ /08/ /01/15 01/16/15 Responsible Party: Director of Compliance/QA POLICY & PROCEDURE TITLE: Variance Reporting Scope/Purpose: The purpose of Variance Reporting is provide a systematic method for reporting adverse events in order to improve systems and processes in an

More information

Administrative Policies and Procedures

Administrative Policies and Procedures Administrative Policies and Procedures Originating Venue: Environment of Care Policy No.: EC 2007 Title: Environment of Care Management Program Cross Reference: EC 2001 Date Issued: 04/14 Authority Environmental

More information

Adverse Events: Thorough Analysis

Adverse Events: Thorough Analysis CMS TRANSPLANT PROGRAM QUALITY WEBINAR SERIES Adverse Events: Thorough Analysis James Ballard, MBA, CPHQ, CPPS, HACP Eileen Willey, MSN, BSN, RN, CPHQ, HACP QAPI Specialist/ Quality Surveyor Educators

More information

Response to Safety Events Just Culture HR Policy 5.24 Page 1 of 10

Response to Safety Events Just Culture HR Policy 5.24 Page 1 of 10 Response to Safety Events Just Culture HR Policy 5.24 Page 1 of 10 Policy : 5.24 Subject: Supersedes: Effective: October 8, 2008 Revised: July 1, 2002, December 1, 2012 Reviewed: December 1, 2012 Response

More information

Safety Reporting in Clinical Research Policy Final Version 4.0

Safety Reporting in Clinical Research Policy Final Version 4.0 Safety Reporting in Clinical Research Policy Final Version 4.0 Category: Summary: Equality Assessment undertaken: Impact Policy The Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent

More information

Post Market Surveillance Requirements. SAMED Regulatory Conference 2 December 2015

Post Market Surveillance Requirements. SAMED Regulatory Conference 2 December 2015 Post Market Surveillance Requirements SAMED Regulatory Conference 2 December 2015 Topics Surveillance & Vigilance Adverse Events Reportable Adverse Events Reporting Adverse Events Time frames Exemptions

More information

To establish a consistent process for the activity of an independent double-check prior to medication administration, where appropriate.

To establish a consistent process for the activity of an independent double-check prior to medication administration, where appropriate. TITLE INDEPENDENT DOUBLE-CHECK SCOPE Provincial, Clinical DOCUMENT # PS-60-01 APPROVAL LEVEL Senior Operating Officer, Pharmacy Services SPONSOR Provincial Medication Management Committee CATEGORY Patient

More information

UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD REPORTING UNANTICIPATED PROBLEMS INCLUDING ADVERSE EVENTS

UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD REPORTING UNANTICIPATED PROBLEMS INCLUDING ADVERSE EVENTS UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD REPORTING UNANTICIPATED PROBLEMS INCLUDING ADVERSE EVENTS I. PURPOSE To specify the procedures for reporting unanticipated problems,

More information

PROMPTLY REPORTABLE EVENTS

PROMPTLY REPORTABLE EVENTS PROMPTLY REPORTABLE EVENTS PURPOSE AND SCOPE To define the structure and responsibility for reporting unanticipated problems that occurs during the conduct of research. APPLICABLE REGULATIONS Policy II.02

More information

Safety in the Pharmacy

Safety in the Pharmacy Safety in the Pharmacy Course Practicum in Health Science - Pharmacology Unit I Preparation for Practicum Essential Question Why is safety in the pharmacy important not only to the patient, but the pharmacy

More information

MINNESOTA. Downloaded January 2011

MINNESOTA. Downloaded January 2011 MINNESOTA Downloaded January 2011 4658.1300 MEDICATIONS AND PHARMACY SERVICES; DEFINITIONS. Subpart 1. Controlled substances. "Controlled substances" has the meaning given in Minnesota Statutes, section

More information

Principles In developing these recommendations the Consensus Panel first established the following principles for anesthesia outcomes capture:

Principles In developing these recommendations the Consensus Panel first established the following principles for anesthesia outcomes capture: Outcomes of Anesthesia: Core Measures The following Core Measures are the consensus recommendations of the Anesthesia Quality Institute (AQI) and the Multicenter Perioperative Outcomes Group (MPOG). They

More information

Harborview Medical Center

Harborview Medical Center Harborview Medical Center To improve care & patient outcomes To improve safety To prevent financial losses To reduce the impact of financial losses Harborview Medical Center 2 You are the key to successful

More information

Penticton & District Community Resources Society. Child Care & Support Services. Medication Control and Monitoring Handbook

Penticton & District Community Resources Society. Child Care & Support Services. Medication Control and Monitoring Handbook Penticton & District Community Resources Society Child Care & Support Services Medication Control and Monitoring Handbook Revised Mar 2012 Table of Contents Table of Contents MEDICATION CONTROL AND MONITORING...

More information

The Medicines Policy. Chapter 6: Standards of Practice. MISCELLANEOUS and DISCHARGE

The Medicines Policy. Chapter 6: Standards of Practice. MISCELLANEOUS and DISCHARGE Chapter 6: Standards of Practice MISCELLANEOUS and DISCHARGE V2.1 Date: October 2015 CHAPTER 6 CONTENTS 6.5. Miscellaneous... 3 6.5.1 Patients Moving Between Healthcare Trusts... 3 6.5.1.1 Transfer of

More information

Medication Safety & Electrolyte Administration. Objectives. High Alert Medications. *Med Safety Electrolyte Administration

Medication Safety & Electrolyte Administration. Objectives. High Alert Medications. *Med Safety Electrolyte Administration Medication Safety & Electrolyte Administration Jennifer Doughty, PharmD PGY2 Pharmacy Resident Emergency Medicine Stormont Vail Health, Topeka, KS Objectives Define and identify high alert medications

More information

Storage, Labeling, Controlled Medications Instructor s Guide CFR (b)(2)(3)(d)(e) F431

Storage, Labeling, Controlled Medications Instructor s Guide CFR (b)(2)(3)(d)(e) F431 Centers for Medicare & Medicaid Services (CMS) Storage, Labeling, Controlled Medications Instructor s Guide CFR 483.60(b)(2)(3)(d)(e) F431 2006 Prepared by: American Institutes for Research 1000 Thomas

More information

Adverse reactions identification and documentation

Adverse reactions identification and documentation Adverse reactions identification and documentation Contents Policy... 1 Purpose... 2 Scope... 2 Associated documents... 2 Responsibilities on admission for capture and documentation... 3 Admission Staff

More information

Risk Assessment Form HS 9 (1)

Risk Assessment Form HS 9 (1) s Full Name: Date of Birth: NHS Number 1. The fully implanted port system Sitimplant is not regularly used in the community and nursing staff may be unfamiliar with the recommended care of this system

More information

REVISED FIP BASEL STATEMENTS ON THE FUTURE OF HOSPITAL PHARMACY

REVISED FIP BASEL STATEMENTS ON THE FUTURE OF HOSPITAL PHARMACY REVISED FIP BASEL STATEMENTS ON THE FUTURE OF HOSPITAL PHARMACY Approved September 2014, Bangkok, Thailand, as revisions of the initial 2008 version. Overarching and Governance Statements 1. The overarching

More information

PROCEDURE Client Incident Response, Reporting and Investigation

PROCEDURE Client Incident Response, Reporting and Investigation PROCEDURE Client Incident Response, Reporting and Investigation 1. PURPOSE The purpose of this procedure is to ensure that incidents involving Senses Australia s clients are responded to, reported, investigated

More information

One or More Errors in 67% of the IV Infusions: Insights from a Study of IV Medication Administration

One or More Errors in 67% of the IV Infusions: Insights from a Study of IV Medication Administration One or More Errors in 67% of the IV Infusions: Insights from a Study of IV Medication Administration Presented by: Marla Husch Northwestern Memorial Hospital Northwestern Memorial Hospital Chicago, Illinois

More information

HealthStream Ambulatory Regulatory Course Descriptions

HealthStream Ambulatory Regulatory Course Descriptions This course covers three related aspects of medical care. All three are critical for the safety of patients. Avoiding Errors: Communication, Identification, and Verification These three critical issues

More information

SARASOTA MEMORIAL HOSPITAL STANDARDS OF CARE STANDARDS OF PRACTICE DEPARTMENT OF IV THERAPY (IV THERAPISTS)

SARASOTA MEMORIAL HOSPITAL STANDARDS OF CARE STANDARDS OF PRACTICE DEPARTMENT OF IV THERAPY (IV THERAPISTS) UNIT: SARASOTA MEMORIAL HOSPITAL STANDARDS OF CARE STANDARDS OF PRACTICE DEPARTMENT OF IV THERAPY (IV THERAPISTS) STANDARD #: EFFECTIVE DATE: REVISED DATE: STANDARD TYPE: 04/91 5/05, 3/08 DEPARTMENTAL

More information

Consumers Union/Safe Patient Project Page 1 of 7

Consumers Union/Safe Patient Project Page 1 of 7 Improving Hospital and Patient Safety: An overview of recently passed legislation and requirements towards improving the safety of California s hospital patients June 2009 Background Since 2006 several

More information

Transfusion Safety in Practice. Ana Lima Transfusion Safety Nurse Sunnybrook Health Sciences Centre Toronto, Ontario CANADA

Transfusion Safety in Practice. Ana Lima Transfusion Safety Nurse Sunnybrook Health Sciences Centre Toronto, Ontario CANADA Transfusion Safety in Practice Ana Lima Transfusion Safety Nurse Sunnybrook Health Sciences Centre Toronto, Ontario CANADA The Evolving Role of Nurses in Transfusion Hong Kong: 1 December 2017 Nurses and

More information

Non-Employee and Employee Incident Reporting

Non-Employee and Employee Incident Reporting Non-Employee and Employee Incident Reporting Training Objectives 1. Completing and submitting an incident form: a. for an employee (Employee Incident) b. for a patient/person involved incident (Non-Employee

More information

ACRIN ADVERSE EVENT REPORTING MANUAL. 1 March 2006 v.3

ACRIN ADVERSE EVENT REPORTING MANUAL. 1 March 2006 v.3 AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK ADVERSE EVENT REPORTING MANUAL 1 Prepared by the American College of Radiology Imaging Network Administrative Center September 2002 Revised March 2006 American

More information

POSITION DESCRIPTION COUNTY OF STEUBEN, INDIANA

POSITION DESCRIPTION COUNTY OF STEUBEN, INDIANA POSITION DESCRIPTION COUNTY OF STEUBEN, INDIANA POSITION: DEPARTMENT: Ambulance Service WORK SCHEDULE: 12 hour shifts, rotating schedule JOB CATEGORY: POLE (Protective Occupations, Law Enforcement) DATE

More information

Sponsor Responsibilities. Roles and Responsibilities. EU Directives. UK Law

Sponsor Responsibilities. Roles and Responsibilities. EU Directives. UK Law EU Directives Pharmacovigilance Legislation, SOPs and Reporting Louise Boldy, Governance & Safety Manager David Martin, Pharmacovigilance Monitor EU Legislation 2001/20/EC 2005/28/EC EudraLex Vol 10 UK

More information

C. Physician s orders for medication, treatment, care and diet shall be reviewed and reordered no less frequently than every two (2) months.

C. Physician s orders for medication, treatment, care and diet shall be reviewed and reordered no less frequently than every two (2) months. SECTION 1300 - MEDICATION MANAGEMENT 1301. General A. Medications, including controlled substances, medical supplies, and those items necessary for the rendering of first aid shall be properly managed

More information

Clinical. Medication Errors and Medicine Defect Reporting SOP. Document Control Summary. Contents

Clinical. Medication Errors and Medicine Defect Reporting SOP. Document Control Summary. Contents Clinical Medication Errors and Medicine Defect Reporting SOP Document Control Summary Status: Version: Author/Owner/Title: Approved by: Ratified: Related Trust Strategy and/or Strategic Aims Implementation

More information

Abuse and Neglect Investigation: Alaska Psychiatric Institute (API) API Violates Patients Rights in Handling Patients Grievances

Abuse and Neglect Investigation: Alaska Psychiatric Institute (API) API Violates Patients Rights in Handling Patients Grievances Abuse and Neglect Investigation: Alaska Psychiatric Institute (API) API Violates Patients Rights in Handling Patients Grievances Issued April 5, 2011 Revised and reissued July 13, 2011 1 The Disability

More information

Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices

Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices SUR-G0003-4 09 JULY 2012 This guide does not purport to be an interpretation of law and/or regulations and

More information

NOTE: The first appearance of terms in bold in the body of this document (except titles) are defined terms please refer to the Definitions section.

NOTE: The first appearance of terms in bold in the body of this document (except titles) are defined terms please refer to the Definitions section. TITLE CLINICAL ADVERSE EVENTS SCOPE Provincial APPROVAL AUTHORITY Quality Safety and Outcomes Improvement Executive Committee SPONSOR Quality and Healthcare Improvement PARENT DOCUMENT TITLE, TYPE AND

More information

IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES

IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES DOCUMENT NO.: CR012 v2.0 AUTHOR: Raymond French ISSUE DATE: 18 September 2017 EFFECTIVE DATE: 02 October

More information

Intra-operative Cell Salvage. Competency Assessment Workbook. Trainee: Hospital: Trainer/Supervisor: Date Commenced: Date Completed:

Intra-operative Cell Salvage. Competency Assessment Workbook. Trainee: Hospital: Trainer/Supervisor: Date Commenced: Date Completed: Intra-operative Cell Salvage Competency Assessment Workbook Trainee: Hospital: Trainer/Supervisor: Commenced: Completed: Contents Introduction 1-2 Record of Assessors 4 Confirmation of Required Pre-assessment

More information

ASSISTING STUDENTS WITH MEDICATIONS AND THEIR HEALTHCARE NEEDS

ASSISTING STUDENTS WITH MEDICATIONS AND THEIR HEALTHCARE NEEDS Administrative Rule ASSISTING STUDENTS WITH MEDICATIONS AND THEIR HEALTHCARE NEEDS Code JLCD-R Issued 10/07 The needs of children who require medication during school hours to maintain and support presence

More information

Standards for the Operation of Licensed Pharmacies

Standards for the Operation of Licensed Pharmacies Standards for the Operation of Licensed Pharmacies Introduction These standards are made under the authority of Section 29.1 of the Pharmacy and Drug Act. They are one component of the law that governs

More information

UPMC POLICY AND PROCEDURE MANUAL

UPMC POLICY AND PROCEDURE MANUAL 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

More information

CRAIG HOSPITAL POLICY/PROCEDURE

CRAIG HOSPITAL POLICY/PROCEDURE CRAIG HOSPITAL POLICY/PROCEDURE Approved: P&T, MEC, NPC, P&P 03/09 Effective Date: 02/95 P&T, MEC, P&P 08/09; P&P 08/10; P&T, MEC 10/10, P&T, P&P 12/10 ; MEC 01/11; P&T, MEC 02/11, 04/11 ; P&T, P&P 12/11

More information

KENT HOSPITAL POLICY/PROCEDURE SUBJECT: AUTHORS: APPROVAL DATE: POLICY NUMBER: January 2012 EFFECTIVE DATE: January January 2013 NPP600-E-6

KENT HOSPITAL POLICY/PROCEDURE SUBJECT: AUTHORS: APPROVAL DATE: POLICY NUMBER: January 2012 EFFECTIVE DATE: January January 2013 NPP600-E-6 KENT HOSPITAL POLICY/PROCEDURE SUBJECT: AUTHORS: APPROVAL DATE: POLICY NUMBER: January 2012 Fall Prevention Barbara Bird, MSN, RN-BC, CCNS EFFECTIVE DATE: 8310-0005 Falls Council/ Prevention Committee

More information

Regulatory Compliance Policy No. COMP-RCC 4.60 Title:

Regulatory Compliance Policy No. COMP-RCC 4.60 Title: I. SCOPE: Regulatory Compliance Policy No. COMP-RCC 4.60 Page: 1 of 6 This policy applies to (1) Tenet Healthcare Corporation and its wholly-owned subsidiaries and affiliates (each, an Affiliate ); (2)

More information

SARASOTA MEMORIAL HOSPITAL NURSING DEPARTMENT POLICY

SARASOTA MEMORIAL HOSPITAL NURSING DEPARTMENT POLICY PS1006 SARASOTA MEMORIAL HOSPITAL NURSING DEPARTMENT POLICY TITLE: NURSING AND PHARMACY GUIDELINES FOR THE ADMINISTRATION OF IV TREPROSTINIL (REMODULIN ) Job Title of Reviewer: Director, Pharmacy POLICY

More information

SARASOTA MEMORIAL HOSPITAL

SARASOTA MEMORIAL HOSPITAL SARASOTA MEMORIAL HOSPITAL TITLE: ISSUED FOR: NURSING PROCEDURE Nursing DATE: REVIEWED: PAGES: RESPONSIBILITY: RN, LPN I, LPN II Per Job Description 03/93 2/18 1 of 6 PURPOSE: KNOWLEDGE BASE: To provide

More information

SECTION HOSPITALS: OTHER HEALTH FACILITIES

SECTION HOSPITALS: OTHER HEALTH FACILITIES SECTION.1400 - HOSPITALS: OTHER HEALTH FACILITIES 21 NCAC 46.1401 REGISTRATION AND PERMITS (a) Registration Required. All places providing services which embrace the practice of pharmacy shall register

More information

SARASOTA MEMORIAL HEALTH CARE SYSTEM CORPORATE POLICY

SARASOTA MEMORIAL HEALTH CARE SYSTEM CORPORATE POLICY SARASOTA MEMORIAL HEALTH CARE SYSTEM CORPORATE POLICY TITLE: ADMINISTRATION OF BLOOD AND EFFECTIVE DATE: REVIEWED/REVISED DATE: POLICY TYPE: 10/15/79 08/31/17 Clinical 1 of 7 Non-Clinical Job Title of

More information

Incident Management June 2018

Incident Management June 2018 Incident Management June 2018 Table of Contents 1.0 Purpose... 1 2.0 Scope... 1 3.0 Definitions... 1 4.0 Responsibilities... 2 4.1. Senior Executives, Deans and Directors... 2 4.2. Supervisors... 3 4.3.

More information

FLORIDA DEPARTMENT OF CORRECTIONS OFFICE OF HEALTH SERVICES HEALTH SERVICES BULLETIN NO Page 1 of 8

FLORIDA DEPARTMENT OF CORRECTIONS OFFICE OF HEALTH SERVICES HEALTH SERVICES BULLETIN NO Page 1 of 8 FLORIDA DEPARTMENT OF CORRECTIONS OFFICE OF HEALTH SERVICES HEALTH SERVICES BULLETIN NO. 15.03.22 Page 1 of 8 I. PURPOSE: The purpose of this health services bulletin is to provide guidelines: A. For a

More information

CONTENTS. 8. Procedure in the event of contact with blood or other bodily fluid

CONTENTS. 8. Procedure in the event of contact with blood or other bodily fluid First Aid Policy CONTENTS 1. Roles and Responsibilities 2. First Aid Boxes 3. Information on Students 4. Policy for students with medical conditions that are known to the school 5. Managing medicines on

More information

Medication Management Policy and Procedures

Medication Management Policy and Procedures POLICY STATEMENT This policy establishes guidelines for ensuring safe and correct management of client medications in accordance with legislative and regulatory requirements and professional practice competency

More information

Healthcare Competency Skills/Evaluation (Page 1 of 5)

Healthcare Competency Skills/Evaluation (Page 1 of 5) (Page 1 of 5) COMPETENCY SKILLS 1 of 5 1 = Cannot Perform Skills Independently EVS Tech 2 = Requires Some Assistance to Perform Skills EVS OR Tech 3 = Can Perform Independently EVS Floor Tech NA = Not

More information

JOB DESCRIPTION. Specialist Practitioner of Transfusion for Shrewsbury, Telford and surrounding community hospitals. Grade:- Band 7 Line Manager:-

JOB DESCRIPTION. Specialist Practitioner of Transfusion for Shrewsbury, Telford and surrounding community hospitals. Grade:- Band 7 Line Manager:- JOB DESCRIPTION Job Title:- Specialist Practitioner of for Shrewsbury, Telford and surrounding community hospitals. Grade:- Band 7 Line Manager:- Associate Director of Patient Safety Professionally Accountability

More information

National Patient Safety Agency Root Cause Analysis (RCA) Investigation

National Patient Safety Agency Root Cause Analysis (RCA) Investigation National Patient Safety Agency Root Cause Analysis (RCA) Investigation Margaret O Donovan Assistant Director for Acute Services Types of failure Active failures - slips, lapses, fumbles, mistakes, procedural

More information

PATIENT SAFETY OVERVIEW

PATIENT SAFETY OVERVIEW PATIENT SAFETY OVERVIEW MUHAMMAD ISLAM, MBBS, MS, MCH DIRECTOR OF PATIENT SAFETY SUNY DOWNSTATE MEDICAL CENTER 1 DEFINITIONS Patient Safety is a process that guards against any adverse condition occurring

More information

Intravenous Infusion Practices and Patient Safety: Insights from ECLIPSE

Intravenous Infusion Practices and Patient Safety: Insights from ECLIPSE Intravenous Infusion Practices and Patient Safety: Insights from ECLIPSE Acknowledgement and disclaimer Funding acknowledgement: This project is funded by the National Institute for Health Research Health

More information

Stratford Board of Education

Stratford Board of Education POLICY STATEMENT FOR ADMINISTRATION OF MEDICATIONS BY SCHOOL PERSONNEL It is the policy of the Stratford Board of Education to be in conformity with Section 10 212a 1 to 10 212a 7, as revised of the General

More information

RULE RESPONSIBILITIES OF A PHYSICIAN WHO ENGAGES IN DRUG THERAPY MANAGEMENT WITH A COLORADO LICENSED PHARMACIST

RULE RESPONSIBILITIES OF A PHYSICIAN WHO ENGAGES IN DRUG THERAPY MANAGEMENT WITH A COLORADO LICENSED PHARMACIST DEPARTMENT OF REGULATORY AGENCIES Colorado Medical Board RULE 900 - RESPONSIBILITIES OF A PHYSICIAN WHO ENGAGES IN DRUG THERAPY MANAGEMENT WITH A COLORADO LICENSED PHARMACIST 3 CCR 713-32 [Editor s Notes

More information

PATIENT SAFETY KNOWLEDGEBASE. How to prepare for a Survey

PATIENT SAFETY KNOWLEDGEBASE. How to prepare for a Survey PATIENT SAFETY KNOWLEDGEBASE How to prepare for a Survey 1 DEFINITIONS Patient Safety v is a process that guards against any adverse condition occurring in a patient as a result of wrong diagnosis or treatment

More information

Unlicensed Medicines Policy Document

Unlicensed Medicines Policy Document Unlicensed Medicines Policy Document Effective: February 2002 (Intranet 2006) Review date: February 2007 A. Introduction In order to ensure that medicines are safe and effective the manufacture and sale

More information

M. Rickard, Research Governance and GCP Manager R. Fay Research Governance and GCP Manager Elizabeth Clough, Governance Operations Manager

M. Rickard, Research Governance and GCP Manager R. Fay Research Governance and GCP Manager Elizabeth Clough, Governance Operations Manager Standard Operating Procedures (SOP) for: Pharmacovigilance and Safety Reporting for Sponsored non-ctimps SOP Number: 26b Version 2.0 Number: Effective Date: 29th November 2015 Review Date: 3 rd December

More information

Administration of First Aid

Administration of First Aid SAMPLE POLICY Administration Policy Statement The First Aid Policy, strategies and practices are designed to support educators to: Ensure that ill or injured persons are stabilised and comforted until

More information

MEDICATION ADMINISTRATION POLICY POLICY, PROCEDURES, & GUIDELINES FOR MEDICATION ADMINISTRATION II. PROCEDURES FOR MEDICATION ADMINISTRATION

MEDICATION ADMINISTRATION POLICY POLICY, PROCEDURES, & GUIDELINES FOR MEDICATION ADMINISTRATION II. PROCEDURES FOR MEDICATION ADMINISTRATION Insytt-ma-procedures 08-09; 02-17 page 1 of 7 MEDICATION ADMINISTRATION POLICY POLICY, PROCEDURES, & GUIDELINES F MEDICATION ADMINISTRATION II. PROCEDURES F MEDICATION ADMINISTRATION Procedures used for

More information