SJMHS SAFE MEDICAL DEVICE ACT (SMDA) 7/2017
|
|
|
- Brian Webb
- 5 years ago
- Views:
Transcription
1 SJMHS SAFE MEDICAL DEVICE ACT (SMDA) 7/2017
2 2 Objectives Upon completion of this course you should be able to: Describe the steps to take to report an adverse event with a medical device at your site Locate the reporting tools (VOICE for patients/visitors /students and THEIR for colleagues), to report issues State a few examples of a medical device Comply with the Safe Medical Device Act (SMDA)
3 3 What is the SMDA? Since December 13, 1984, the Federal Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. The Safe Medical Devices Act (SMDA) of 1990 provided the FDA with two additional post-marketing activities, Monitoring of products after their clearance to market and Tracking for maintaining traceability of certain devices to the user level.
4 4 What is the SMDA? Continued... The Safe Medical Devices Act (SMDA) requires healthcare professionals to report death or injuries caused or suspected to have been caused by a particular medical device to the FDA or the product's manufacturer. The goal is to quickly inform the FDA of the danger so that the issue can be tracked and/or the product recalled. The hospital must file the report within ten working days after the event is determined to be reportable. Hospitals and Physician offices are required to submit a report summary citing all device-related incidents within the last year of the previous submission.
5 5 Medical Device Defined A medical device is defined by the Safe Medical Devices Act of 1990 to include any instrument, apparatus, or other article that is used to prevent, diagnose, mitigate or treat a disease as to affect the structure or function of the body with the exception of drugs. A medical device can range from gauze sponges to implanted devices such as a pacemaker.
6 Medical Device Examples Capital Equipment cribs, bedrails, scales, wheelchairs, IV poles, infusion pumps, bathing tubs, blood pressure equipment, Radiology equipment Instruments lab equipment, surgical staplers, glucose meters, pulse oximeters Monitoring Systems cardiac, telemetry, patient call systems Reagents laboratory solutions Disposables and Accessories ventilator breathing circuits, filters needles, syringes, trocars, IV catheters, IV tubing, foley catheters, feeding tubes, gloves Implantable defibrillators, shunts, joint replacements Computerized Medical Systems hardware software versions
7 Why is reporting medical device problems important in our hospital? Reporting helps us to... Prevent future problems and protect our patients, staff, families, and visitors Achieve performance improvement goals Assist Risk Management with claims or litigation Provide information to manufacturers and/or FDA Impact the public health for the nation s patients and/or healthcare providers Effect changes in policies and procedures
8 8 What should you do if you come upon an incident that falls under the SMDA? Your role is to... Attend to the needs of the injured person. Notify your supervisor/manager and the Clinical Quality, Safety & Risk (QSR) department. Remove the device from service, put an equipment malfunction tag on it, and notify the Clinical Engineering department. Do not attempt to troubleshoot or alter any settings. Save all materials related to the incident in their original condition. If possible, save all disposables and packaging. Label items/ record serial numbers/ identification numbers. Your concerns will be investigated and the QSR department will notify the FDA via MedWatch (electronic Reporting Form 3500), if needed.
9 9 Patient / Visitor / Student Incidents Complete a VOICE file to document patient, visitor, and student incidents. From the home page of the SJMHS Intranet/Sharepoint, click on to submit a report
10 10 Colleague Incidents Complete a Trinity Health Employee Incident Report for colleagues. From the ZENworks Window Application Launcher on any TH computer click on and complete the required fields OR From the home page of the SJMHS Intranet / SharePoint click on to submit a Colleague report.
11 You have completed: SJMHS Safe Medical Device Act 11 If you have questions/feedback on this course contact: Your Manager, or SJMAA, SJMC, SJML: Connie Hall-Burke, Director Clinical Quality, Safety, and Risk SJMO: Morris Pajewski, Director Organization Quality SMML: Stephanie McMahon, Director Medical Staff Service and Quality Publisher: Kathleen Hay, MS, MT(ASCP), E-Learning Consultant, SJMAA,
Pediatric Medical Device Development and Safety. Jacqueline N. Francis, MD, MPH Medical Officer, PSRB, ODE, CDRH, FDA
Pediatric Medical Device Development and Safety Jacqueline N. Francis, MD, MPH Medical Officer, PSRB, ODE, CDRH, FDA This presentation represents the professional opinion of the speaker and is not an official
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
EMERGING TRENDS WHAT I WILL COVER INCREASED INTEREST DEVICES ARE MIGRATING SAFE AND RELIABLE DEVICES LEAD TO LIVING WELL
SAFE AND RELIABLE DEVICES LEAD TO LIVING WELL THE HOME AND MEDICAL DEVICE TECHNOLOGY Presented by Mary Weick-Brady, MSN, RN April 20, 2012 Great Lakes Biomedical Conference on Home and Mobile Health WHAT
U-M Hospitals and Health Centers Policies and Procedures
U-M Hospitals and Health Centers Policies and Procedures UMHHC Policy 05-02-006 Safe Medical Device Act Policy Issued: 4/00; Last Reviewed: 10/04; Last Revised: 10/04 Return to UMHHC Policies Table of
Texas Tech University Health Sciences Center El Paso
Texas Tech University Health Sciences Center El Paso Medical Equipment Management Plan Medical Equipment Management Plan Contents I. Objective and Purpose II. III. IV. Selection and Acquisition Equipment
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
QA offers significant economic benefits!
and Safety Systems in the USA J. Tobey Clark, MSEE, CCE, SASHE University of Vermont, USA Definitions Quality assurance Planned and systematic actions that can be demonstrated to provide confidence that
This document is NOT FOR PROMOTIONAL USE. Do not copy, distribute, or share with physicians, staff, or patients. FOR INTERNAL USE ONLY.
SIMPONI ARIA Infusion Suite Module Summary Page 1 of 5 The trademark, SIMPONI ARIA, has received provisional acceptance from the FDA. SIMPONI ARIA is an investigational agent currently under review by
DOES TECHNOLOGY KEEP PATIENTS OUT OF HOSPITALS?
DOES TECHNOLOGY KEEP PATIENTS OUT OF HOSPITALS? Jeff Shuren, MD, JD Center for Devices and Radiological Health Food and Drug Administration November 6, 2014 1 Overview Challenges Medical Devices Used in
Limitations and Guidelines Revised for Elastomeric Devices and IV Supplies and Equipment
Limitations and Guidelines Revised for Elastomeric Devices and IV Supplies and Equipment Information posted January 8, 2007 Effective for dates of service on or after March 1, 2007, benefit limitations
About the Critical Care Center
Patient and Family Education Section 2 About the Critical Care Center The 5-Southeast and 5-East units 5-Southeast and 5-East When You Arrive for a Visit Patient Services Specialist Waiting Rooms Patient
DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES Medication Administration Observation
: Make random medication observations of several staff over different shifts and units, multiple routes of administration -- oral, enteral, intravenous (IV), intramuscular (IM), subcutaneous (SQ), topical,
Equipment Technology Malfunctions
Equipment Technology Malfunctions Course Principles of Health Science Unit X Vital Signs Essential Question Why is it important to have a Medical Equipment Management Plan in place? TEKS 130.202 11(B)
Companion Animal Facility Equipment List
San Juan College Veterinary Technology Distance Learning Program 4601 College Boulevard Farmington, NM 87402 Off Campus Clinical Instruction (OCCI) Site Application for Companion Animal Facilities INSTRUCTIONS
MEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL EMERGENCY PROCEDURES FOR CLINICAL TRIAL SITES This document highlights the importance of having emergency standard operating procedures in place during the conduct of clinical
Medical Device Reporting. FD&C Act CFR Direct Final Rule 2/28/05. As amended by:
Medical Device Reporting Direct Final Rule 2/28/05 FD&C Act 519 As amended by: Safe Medical Devices Act of 1990 Medical Device Amendments of 1992 FDA Modernization Act of 1997 Authority to require manufacturers,
STATEMENT. JEFFREY SHUREN, M.D., J.D. Director, Center for Devices and Radiological Health Food and Drug Administration
STATEMENT JEFFREY SHUREN, M.D., J.D. Director, Center for Devices and Radiological Health Food and Drug Administration Institute of Medicine Committee on Patient Safety and Health Information Technology
RNSG Pre-Class Activities REQUIRED Ticket to Lab*
Week 1 January 19-24 Online course ientation in Blackboard (Bb) course site (No Lab until next week) Week 2 January 25 January 28 1: Infection Control Medical & Surgical Asepsis 28 Module 2 Basic Skills/Basic
Employed Student Nurse (ESN) Application Form
Applicant Information: Deadline for submission is November 30, 2017. Please email the application to esn@phsa.ca Last Name : Given Names: Address: Email: Contact Number(s): Nursing Program / Course Information:
Medical Devices Policy
Medical Devices Policy Reference No: Version: 8 P-CS-09 Ratified by: LCHS Trust Board Date ratified: 12 th September 2017 Name of originator/author: Medical Devices Committee Name of approving committee/responsible
Changes in the Medical Device Legislation; the day after. Jan Bart Hak 1
PPN Najaarsbijeenkomst 21 November 2017 Changes in the Medical Device Legislation; the day after. How much time do we have left? Jan Bart Hak Jan Bart Hak 1 Company Leading consultancy and project management
Course Outline and Assignments
Course Outline and Assignments WEEK ONE 10-16-12 Instructional In Class-Learning to be completed prior to class 10-17-12 Total Hours Assessment 1. proper hand washing techniques 2. donning and removing
St. Vincent s East Page 1 of 5
St. Vincent s East Page 1 of 5 TITLE: PATIENT CARE PRACTICE GUIDELINE CARE OF PATIENTS BLOOD AND BLOOD COMPONENTS - ADMINISTRATION FACILITY: FUNCTION: ORIGINATING DEPT: St. Vincent s East HOSPITAL SHARED
STANDARDIZED PROCEDURE HEPATIC ARTERY INFUSION OF CHEMOTHERAPY (Adults, Peds)
I. Definition Hepatic arterial infusion (HAI) of chemotherapy is accomplished by a small drug delivery system or pump that is implanted in a subcutaneous pocket in the lower abdomen. The pump reservoir
Nursing. Lab Name Location Person in Charge Programs Served Courses Served. M Muna Al -Tamimi Nursing Department
Central Laboratories Catalog Nursing Laboratories Nursing Lab Name Location Person in Charge Programs Served Courses Served Maternity & Child Health Nursing & Basic Life Support (BLS) Skills Lab Fundamentals
SPOK MESSENGER. Improving Staff Efficiency and Patient Care With Timely Communications and Critical Connectivity
SM SPOK MESSENGER Improving Staff Efficiency and Patient Care With Timely Communications and Critical Connectivity THE CHALLENGE OF PROVIDING PATIENT CARE WHILE MAINTAINING EFFICIENCY Many hospitals today
Guidelines on Postanaesthetic Recovery Care
Page 1 of 10 Guidelines on Postanaesthetic Recovery Care Version Effective Date 1 OCT 1992 2 FEB 2002 3 APR 2012 4 JUN 2017 Document No. HKCA P3 v4 Prepared by College Guidelines Committee Endorsed by
Administrative Policies and Procedures. Policy No.: N/A Title: Medical Equipment Management Plan
Administrative Policies and Procedures Originating Venue: Environment of Care Title: Medical Equipment Management Plan Cross Reference: Date Issued: 11/14 Date Reviewed: Date: Revised: Attachment: Page
HUSKY Health Program Member Benefits Grid. Covered Services for HUSKY A, C, and D
HUSKY Health Program Member Benefits Grid Covered Services for HUSKY A, C, and D All services must be medically necessary. For information on wellness exams, screenings and vaccines, click here. Acupuncture
EXPERIENCED TECHNICAL PARTNER/ CERTIFIED NURSING ASSISTANT Classroom Orientation Schedule. March 17, 2014
Lehigh Valley Health Network Division of Education, Clinical Staff Development EXPERIENCED TECHNICAL PARTNER/ CERTIFIED NURSING ASSISTANT Classroom Orientation Schedule March 17, 2014 LVH Program Coordinator:
HUSKY Health Program Member Benefits Grid. Covered Services for HUSKY A, C, and D
HUSKY Health Program Member Benefits Grid Covered Services for HUSKY A, C, and D HUSKY enrolled providers also include: pharmacies, hospitals, medical equipment companies and home health care agencies.
MEDWATCH CONTINUING EDUCATION
MEDWATCH CONTINUING EDUCATION Learning Objectives: IMPROVING PATIENT CARE BY REPORTING PROBLEMS WITH MEDICAL DEVICES Upon completion of this program, health professionals should be able to: Describe what
Medical Simulation Orientation
Medical Simulation Orientation Familiarization with IMSE s METI ECS Simulation Manikin Getting to know the Simulator Aims and Goals of Orientation To allow participants to familiarize themselves with the
A AIRWAY Open the Airway B BREATHING Deliver two (2) Breaths. Code Blue Policy. Indications for Calling A Code Blue
Code Blue Policy Code Blue is a term used to alert the Code Team and hospital staff of the significant deterioration in a patient s status (e.g. unresponsiveness, absence of blood pressure, status epilepticus)
Manager. 2. To establish procedures for selecting and acquiring biomedical equipment.
Page 1 of 8 CENTRAL STATE HOSPITAL POLICY SUBJECT: BIOMEDICAL EQUIPMENT MANAGEMENT ANNUAL REVIEW MONTH: RESPONSIBLE FOR REVIEW: October Regional Safety & Environmental Health Manager LAST REVISION DATE:
Skills/Experience Checklist Home Health Registered Nurse
This form is a self-assessment of your current skills and abilities. This form is also used to document skill demonstration. EMPLOYEE PROFILE Last Name First Name Middle Initial Employee Number Direct
Hospital Acquired Conditions. Tracy Blair MSN, RN
Hospital Acquired Conditions Tracy Blair MSN, RN A hospitalacquired infection (HAI), also known as a nosocomial infection, is an infection that is acquired in a hospital or other health care facility Hospital
Connie Hoy October 2013
Connie Hoy October 2013 Warning letter issued to firm for complaint handling Failure to report within 30 days Failure to implement adequate procedures Failure to establish standard review process No procedure
Equipment Cleaning Guidelines Template
Equipment Cleaning Guidelines Template All patient care equipment must be wiped down and disinfected between each patient. The recommendations for /disinfecting frequency listed below are the minimal standards
21 st Century Health Care Consultants
21 st Century Health Care Consultants Presents 1 Investing in your Infusion Specialty Program Presented by: Rhonda Surgnier RN Becky Tolson RN David Kachel CRNI INFUSION THERAPY OBJECTIVES 2 At the completion
Complaint Handling and Medical Device Reporting (MDRs)
Complaint Handling and Medical Device Reporting (MDRs) FDA Small Business Regulatory Education for Industry (REdI) Bethesda, MD September 26, 2013 Andrew Xiao Consumer Safety Officer, Postmarket and Consumer
MEDWATCH CONTINUING EDUCATION
MEDWATCH CONTINUING EDUCATION Learning Objectives: IMPROVING PATIENT CARE BY REPORTING PROBLEMS WITH MEDICAL DEVICES Upon completion of this program, health professionals should be able to: Describe what
What s in a Kit? A Supply Show and Tell to Facilitate Billing Accuracy. Speaker Disclosures. HCPCS History 3/9/2016
What s in a Kit? A Supply Show and Tell to Facilitate Billing Accuracy Renee Hunt Vice President, Revenue Cycle Management Amerita and Janice Donovan, RN, BSN Regional Director of Nursing New England Life
2016 SUMMER STUDENT NURSE EXTERNSHIP PROGRAM SKILLS CHECK LIST
2016 SUMMER STUDENT NURSE EXTERNSHIP PROGRAM SKILLS CHECK LIST STUDENT NURSE EXTERNNAME SCHOOL OF NURSING STUDENT AGREEMENT: I request the Clinical Skills Check list be released to (hospital/agency). I
Tube Feeding Status Critical Element Pathway
Use this pathway for a resident who has a feeding tube. Review the Following in Advance to Guide Observations and Interviews: Most current comprehensive and most recent quarterly (if the comprehensive
COMPANY PROFILE BARONA. PB: No.91457, CR.No Mob: , Website:
COMPANY PROFILE Introduction Barona Trading and Contracting W.L.L. established in 2014, is a privately held company operating in Doha, Qatar. What makes us different from other established contracting
Infection Prevention and Control in Ambulatory Care Settings: Minimum Expectations for Safe Care
Infection Prevention and Control in Ambulatory Care Settings: Minimum Expectations for Safe Care Melissa Schaefer, MD Division of Healthcare Quality Promotion Centers for Disease Control and Prevention
IMPROVING EFFICIENCY AND COST SAVINGS. Technology Solutions for NHS Hospitals
SM IMPROVING EFFICIENCY AND COST SAVINGS Technology Solutions for NHS Hospitals IMPROVING EFFICIENCY IN A CHANGING HEALTHCARE TECHNOLOGY ENVIRONMENT NHS hospitals and their managing trusts are challenged
ICU Nurse, 10 years experience. Major NHS hospital north of London
NAME AND CONTACT INFO WITHHELD CONTACT PASSPORT USA FOR FURTHER DETAILS. 855.531.8555 ICU Nurse, 10 years experience. Major NHS hospital north of London DATE OF BIRTH: March 1, 1977 NATIONALITY: Filipino.
Table of Contents. Nursing Skills. Page 2 of 8. Nursing School Made Simple Guaranteed 2014 SimpleNursing.com All Rights Reserved.
Table of Contents 1 Universal Competencies... 3 1.1 Universal Elements... 3 2 Critical Thinking Question... 4 3 Documentation... 4 4 Handwashing... 4 5 Moving a patient up in bed... 4 6 Applying restraints...
UPMC PASSAVANT Policy Manual. TITLE/SUBJECT: IntraOsseous Device POLICY NO:
UPMC PASSAVANT Policy Manual TITLE/SUBJECT: IntraOsseous Device POLICY NO: 240.005 DEPARTMENT: Emergency Medicine DATE: April 2015 INDEX TITLE: Dept Specific KEYWORDS: Vascular Access, IO POLICY It is
MARSHALLTOWN MEDICAL & SURGICAL CENTER Marshalltown, Iowa
MARSHALLTOWN MEDICAL & SURGICAL CENTER Marshalltown, Iowa CARE OF PATIENT POLICY & PROCEDURES Policy Number: 4.37 Subject: Implanted Venous Access Device (Infus-A-Port), Nursing Management Of (Indwelling
INFECTION CONTROL SURVEYOR WORKSHEET
Attachment 2 Exhibit 351 INFECTION CONTROL SURVEYOR WORKSHEET Instructions: The following is a list of items that must be assessed during the on-site survey, in order to determine compliance with the infection
Medical Device Recall Report FY FY 2012
Medical Device Recall Report FY 2003- FY 2012 Ann Ferriter Division of Analysis and Program Operations Office of Compliance Center for Devices and Radiological Health Questions Why did FDA draft the Medical
does staff intervene; used? If not, describe.
Use this pathway for a resident who requires or receives respiratory care services (i.e., oxygen therapy, breathing exercises, sleep apnea, nebulizers/metered-dose inhalers, tracheostomy, or ventilator)
Carter Healthcare, Inc
PURPOSE WAIVED TESTING Policy No. 2-047 To define the organization's compliance with waived testing criteria and the need for a certificate of laboratory services. POLICY The Clinical Laboratory Improvement
Guide to Become a Licensed Commercial Ambulance Service in Maryland
Maryland Institute for Emergency Medical Services Systems State Office of Commercial Ambulance Licensing & Regulation 653 West Pratt Street, Room 313 Baltimore, MD 21201-1536 Office: (410) 706-8511 - Fax:
If viewing a printed copy of this policy, please note it could be expired. Got to to view current policies.
If viewing a printed copy of this policy, please note it could be expired. Got to www.fairview.org/fhipolicies to view current policies. Department Policy Entity: Fairview Pharmacy Services Department:
FDA's OMB supporting document for QSr recordkeeping, 7/20/01, page 1 of 7
FDA's OMB supporting document for QSr recordkeeping, 7/20/01, page 1 of 7 DISCLAIMER: This document was prepared by editing the converted PDF file supporting FDA's request to OMB for continuation of record
Family/Caregiver Education Checklist Return Demonstration of Knowledge FIRST 24 HOURS
of Knowledge FIRST 24 HOURS The following checklists will be completed by a PDN RN or LPN to ensure family/caregiver s skill level is adequate to safely take care of their child independently Teaching
During pre-briefing, you will be assigned one of these roles according to the description below to participate in the simulation as a nurse.
Student Instructions for Standardized Simulation NR 452 Eric Chilton PURPOSE The following information is to be used in guiding your preparation and participation in the scenario for this course. This
ADC ED/TRAUMA POLICY AND PROCEDURE Policy 221. I. Title Trauma team Activation Protocol/Roles & Responsibilities of the Trauma Team
Section: ADC Trauma ADC ED/TRAUMA POLICY AND PROCEDURE Policy 221 Subject: Trauma Team Activation Protocol/Roles & Responsibilities of the Trauma Team Trauma Coordinator UTMB respects the diverse culture
SURVEY ON THE PRODUCTION AND PREPARATION OF CYTOSTATIC DRUGS
Please fax the complete questionnaire to: +49 (40) 79 14 36 01 SURVEY ON THE PRODUCTION AND PREPARATION OF CYTOSTATIC DRUGS Date: 1. Identification of your institution Institution: No. of departments:
Subject: Trauma Team Roles and Responsibilities for TRAUMA ACTIVATION patients
UNM Trauma & EM Operational Policies Subject: Trauma Team Roles and Responsibilities for TRAUMA ACTIVATION patients Purpose: To define the roles and responsibilities of personnel responding to trauma activations,
Policy for use of the Royal Marsden Manual of Clinical Nursing Procedures (9th Edition)
Policy for use of the Royal Marsden Manual of Clinical Nursing Procedures (9th Edition) Document Summary This Policy defines the clinical procedures for all Clinical staff (including temporary staff, contracted
DESCRIPTION/OVERVIEW This document standardizes the transfusion of packed red blood cells and/or other blood components.
Applies To: UNM Hospitals & UNMCC Responsible Department: Blood Bank Revised: 5/2017 Procedure Patient Age Group: ( ) N/A (X) All Ages ( ) Newborns ( ) Pediatric ( ) Adult DESCRIPTION/OVERVIEW This document
AGENDA FOR CHANGE NHS JOB EVALUATION SCHEME JOB DESCRIPTION
AGENDA FOR CHANGE NHS JOB EVALUATION SCHEME JOB DESCRIPTION 1. JOB IDENTIFICATION Job Title: Nursing Assistant Reports to (insert job title): Ward Manager/Charge Nurse Department, Ward or Section: Renal
UCLA Santa Monica Medical Center RESPIRATORY THERAPY STAFF MINUTES March, 2018
UCLA Santa Monica Medical Center RESPIRATORY THERAPY STAFF MINUTES March, 2018 GENERAL Ellen Wilson LGBQT TRAINING MANDATORY ETHICS TRAINING MERP Ellen engaged staff and told them of the hospitals budget
GHTF SG2 Guidance: Group work output presentation
GHTF SG2 Guidance: Group work output presentation SG2 Post-market Surveillance & Vigilance SG2 is charged with the task of developing harmonized manufacturers adverse event reporting and other forms of
Effective Traceability of Medical Devices. IMB Safety Notice: SN2010(09) Circulation Date: 13 August 2010
IRIH MDICIN BORD NOIC ffective raceability of Medical Devices NOIC IMB afety Notice: N2010(09) Circulation Date: 13 ugust 2010 MNUCURR/UPPLIR General medical device (GMD), active implantable medical devices
NEW JERSEY. Downloaded January 2011
NEW JERSEY Downloaded January 2011 SUBCHAPTER 29. MANDATORY PHARMACY 8:39 29.1 Mandatory pharmacy organization (a) A facility shall have a consultant pharmacist and either a provider pharmacist or, if
Discussions and Activity at the Federal Level Regarding Management of Electronic Medical Equipment
Discussions and Activity at the Federal Level Regarding Management of Electronic Medical Equipment Lynne Sehulster, PhD, M(ASCP) Health Scientist Best Practices in Medical Device Cleaning and Disinfection
New to Medicaid? 22 Medicaid Services You Should Know About
New to Medicaid? 22 Medicaid Services You Should Know About Here Are 22 Medicaid Services You Should Know About This year Connecticut expanded Medicaid healthcare coverage (HUSKY) by raising the maximum
Pro-QCP SAMPLE REPORT
Pro-QCP SAMPLE REPORT 2016 CarePoint Solutions, Inc. All rights reserved. General Hospital 123 N Main St New York, NY 12345 What is an IQCP? The Individualized Quality Control Plan (IQCP) is the Clinical
Approval Signature: Date of Approval: December 6, 2007 Review Date:
Personal Care Home/Long Term Care Facility Infection Prevention and Control Program Operational Directive Management of Methicillin-Resistant Staphylococcus Aureus (MRSA) Approval Signature: Supercedes:
CLINICAL SKILLS & OBSERVATION CHECKLIST
CLINICAL SKILLS & OBSERVATION CHECKLIST Employee: Please check Yes or No at time of hire and annually for Adult and/or Pediatric experience RN Supervisor: Please date and initial after observation & demonstration
Wyoming State Board of Nursing
Wyoming State Board of Nursing CNAII Training and Competency Evaluation Course Curriculum OVERALL OBJECTIVE: For the Wyoming State Board of Nursing to establish curriculum standards for Level II Certified
School of Nursing Student Laboratory Safety Packet
School of Nursing Student Laboratory Safety Packet 2017-2018 2/17 1 NURSING INTRODUCTION: The primary goal of the nursing skills laboratory is to provide an environment for you to become competent in your
Medication Administration Using the Home Pump (Eclipse)
Medication Administration Using the Home Pump (Eclipse) Phone Number: Nurse/Contact: Receiving IV Therapy in the Home Your doctor has ordered for you to receive your IV medication at home. Receiving IV
POCKET GUIDE TO THE ACCREDITATION STANDARDS (ISO 15189:2014)
(GLENMARIE BRANCH) POCKET GUIDE TO THE ACCREDITATION STANDARDS (ISO 15189:2014) Know the requirement!! Prepared by: Dr.Lily Manorammah Contents INTRODUCTION:... 3 OUR STRATEGY... 3 MANAGEMENT REQUIREMENTS...
Five Top Tips to Prevent Infections in Long-term Care Settings
Five Top Tips to Prevent Infections in Long-term Care Settings Tip No. 1 Vigilance Open Your Eyes Staff Education Reduce Risks Be Proactive Know the Signs and Symptoms of Infection Tip No. 2 Hand Hygiene
PROFESSIONAL STANDARDS OF PRACTICE
PROFESSIONAL STANDARDS OF PRACTICE Index Page Introduction.. 3 Definition.. 4 Standard One... 5 Standard Two.. 6 Standard Three... 7 Standard Four... 8-9 Appendix A: Standards on Infection Control.. 10-13
Infection Prevention Challenges in the Ambulatory Surgery Center : Strategies for a Successful CMS Survey
Infection Prevention Challenges in the Ambulatory Surgery Center : Strategies for a Successful CMS Survey Marilyn Hanchett, RN APIC Senior Director, Clinical Information 1 Program Objectives Discuss common
Healthcare Risk Control
Topics Covered 2016 Administrative Support Services Healthcare Advertising and Marketing Media Relations Social Media in Healthcare Critical Care Clinical Alarms Invasive Lines Pulse Oximetry Risk Management
STANDARDIZED PROCEDURE INTRAVENTRICULAR CHEMOTHERAPY VIA OMMAYA RESERVOIR (Adult, Peds)
I. Definition The administration of chemotherapy via Ommaya Reservoir into cerebrospinal fluid (CSF) for treatment of previously diagnosed central nervous system (CNS) involvement by leukemia and lymphoma
Encouraging pharmacy involvement in pharmacovigilance; an international perspective.
Encouraging pharmacy involvement in pharmacovigilance; an international perspective. Michael R. Cohen, RPh, MS, ScD (hon) DPS (hon) Chairperson, International Medication Safety Network and President, Institute
CENTRAL IOWA HEALTHCARE Marshalltown, Iowa
CENTRAL IOWA HEALTHCARE Marshalltown, Iowa CARE OF PATIENT POLICY & PROCEDURES Policy Number: 4.37 Subject: Implanted Venous Access Device (Infus-A-Port), Nursing Management Of (Indwelling Vascular Access
QUESTIONS PERTINENT TO PRODUCT SELECTION:
QUESTIONS PERTINENT TO PRODUCT SELECTION: Impact on patient outcomes Impact on patient/staff safety Economic considerations Use the following pages to help facilitate discussion with vendors, write your
PATIENT REGISTRATION. Street City State Zip WORK INJURY/ ACCIDENT
PATIENT REGISTRATION, Last First M.I. SEX: Male Female DOB: / _/ AGE: MARITAL STATUS: SS#: - - PHYSICIAN: ADDRESS: Street City State Zip (HOME) (WORK) TEL: - - TEL: - _- CELL: - _- EMAIL: PRIMARY INSURANCE:
Medical Devices Policy
Medical Devices Policy Who Should Read This Policy Target Audience All Clinical Staff Version 1.0 December 2015 Ref. Contents Page 1.0 Introduction 4 2.0 Purpose 4 3.0 Objectives 4 4.0 Process 5 4.1 5.0
HCA Infection Control Surveillance Survey
HCA Infection Control Surveillance Survey HCA is very interested in reducing nosocomial infections in its hospitals. A key to reducing infections is for each hospital to have a robust infection control
Endotracheal Intubation Adult (April 2013)
Endotracheal Intubation Adult (April 2013) Placement of tube into patient s trachea in order to provide pulmonary ventilation. Advanced Life Support procedure Specified in existing regulations. Not authorized
Department Policy. Code: D: MM Entity: Fairview Pharmacy Services. Department: Fairview Home Infusion. Manual: Policy and Procedure Manual
Department Policy Code: D: MM-5615 Entity: Fairview Pharmacy Services Department: Fairview Home Infusion Manual: Policy and Procedure Manual Category: Home Infusion Subject: Chemotherapy Purpose: Ensure
INFECTION CONTROL POLICY DATE: 03/01/01 REVISED: 7/15/09 STATEMENT
Of, INFECTION CONTROL POLICY DEPARTMENT OF RADIOLOGY DATE: 03/01/01 REVISED: 7/15/09 STATEMENT GENERAL The Department of Radiology adheres to the Duke Infection Control policies and the DUMC Exposure Control
Clinical Skills Validation: Alaris Pump System
Clinical Skills Validation: Alaris Pump System These documents are intended for use by CW Nurse Clinical Leadership Team. The method used to implement the validation of the Alaris Pump System is unit specific.
HOME AND COMMUNITY CARE POLICY MANUAL
CHAPTER: 4 HOME HEALTH SERVICES NUMBER: 4 SECTION: CHAPTER CONTENTS PAGE: 1 OF 1 SUBSECTION: EFFECTIVE: JUNE 19, 2018 4.A General Description and Definitions 4.B Home Support Services 4.B.1 Service Needs
CPNE. Clinical Performance in Nursing Examination Study Guide 21 st Edition SUMMARY
CPNE Clinical Performance in Nursing Examination Study Guide 21 st Edition SUMMARY Effective NOVEMBER 2014 2 CONTENTS Clinical Performance in Nursing Examination 3 Summary Description 3 Peripheral Neurovascular
Decontamination of Medical and Laboratory Equipment Prior to Maintenance or Transportation
Decontamination of Medical and Laboratory Equipment Prior to Maintenance or Transportation Version 4.0 Date to be reviewed January 2020 To be reviewed by Medical Engineering Manager Policy Title: Decontamination
Regulatory Control of Diagnostics in Tanzania. Hiiti Sillo Ag. Director General Tanzania Food and Drugs Authority
6 th Consultative Stakeholders Meeting on UN PQ of Medicines, Diagnostics and Vaccines 4-5 April, 2011, Geneva, Switzerland Regulatory Control of Diagnostics in Tanzania Hiiti Sillo Ag. Director General
Appendix A.1 SURGICAL TECHNOLOGIST WORK PROCESS SCHEDULE AND RELATED INSTRUCTION OUTLINE
WORK PROCESS SCHEDULE AND RELATED INSTRUCTION OUTLINE A.1-1 WORK PROCESS SCHEDULE O*NET-SOC CODE: 29-2055.00 RAPIDS CODE: 1051CB This schedule is attached to and a part of these Standards for the above