Regulatory,Quality & Emergency Preparedness. MaryBeth Parache Director, Quality Affairs New York Blood Center
|
|
- Susanna Wilcox
- 6 years ago
- Views:
Transcription
1 Regulatory,Quality & Emergency Preparedness MaryBeth Parache Director, Quality Affairs New York Blood Center 1
2 Regulatory 2
3 Who regulates us? Food and Drug Administration (FDA) Blood, tissue, HCT/P, medical devices Donor recruitment to crossmatch/issue Centers for Medicare and Medicaid Services (CMS) Clinical laboratories (CLIA) 3
4 Who else regulates us? DOT - hazmat transportation and shipping OSHA - blood borne pathogens, chemical safety, workplace safety NRC - irradiators EPA - biohazardous waste disposal State and local - building codes, waste management, other areas depending on state (NYS regulates labs under exemption from CLIA) AABB ** ( accreditation agency) 4
5 FDA Center for Biologics Evaluation & Review CBER regulates a variety of biological products, including blood and blood components blood grouping reagents human tissue and cellular products used in transplantation gene therapy products immune globulins, coagulation factors drugs and devices related to blood banking, HIV test kits 5
6 Why is CBER in the Drugs & Device Business? CBER has delegated authority to regulate: drugs closely related to biologics, such as anticoagulants used in blood collection bags medical devices used in blood banks to produce biologics such as automated cell separators, empty blood bags and transfer sets, blood storage refrigerators and freezers, and laboratory test systems and kits used in blood donor screening 6
7 How does CBER regulate? Reviews & monitors Investigational New Drug Applications Reviews & approves Biologics License Applications (BLAs) and supplements Also responsible for post marketing activities, surveillance, compliance and enforcement 7
8 How does CBER regulate? Pre-Marketing Drugs: IND NDA ANDA Biologics: IND BLA Devices: IDE 510(k) PMA (BLA) Drug Master Files Post-Marketing BLA updates: Annual Reports Supplements: CBE, CBE-30, PAS Required Reporting: BPDR Fatalities Compliance Inspections: 483s Warning Letters Consent Decrees Suspension Revocation Fines and Jail 8
9 FDA Registration All owners or operators of establishments that manufacture blood products, unless exempt under 21 CFR List every blood product manufactured, prepared, or processed for commercial distribution. Register and list products within 5 days of beginning operation, and annually thereafter. Blood product listings must be updated every June and December. That includes most TRANSFUSION SERVICES! 9
10 regulated manufacturing activities versus the practice of medicine 10
11 FDA GxPs and Blood Regs What Where Title cgmps 21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals cgmps 21 CFR 606 Current Good Manufacturing Practice for Blood and Blood Components cgtps 21 CFR 1271 Subpart D Current Good Tissue Practice GLPs 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies GCP ICH-E6 Good Clinical Practice: Consolidated Guidance 11
12 FDA GxPs and Blood Regs What Where Title Establishment Standards Biologics Standards Blood Standards Blood Standards Tissue Standards HCT/P Standards HCT/P Standards HCT/P Standards 21 CFR 600 Biological Products: General 21 CFR 610 General Biological Products Standards 21 CFR 630 General Requirements for Blood, Blood Components, and Blood Derivatives 21 CFR 640 Additional Standards for Human Blood and Blood Components 21 CFR 1270 Human Tissue Intended for Transplantation 21 CFR 1271 Subpart A 21 CFR 1271 Subpart C 21 CFR 1271 Subpart E General Provisions Donor Eligibility Additional Requirements for Establishments Described in
13 FDA Focus on Blood Safety 1. Donor selection (Donor history questionnaire, Mini-physical) 2. Donor deferral registries 3. Testing for infectious agents 4. Quarantine of blood pending lot release 5. Deviation management and corrective actions 6. Change Control 13
14 FDA Inspections Pre-license for BLAs; pre-approval for some supplements GMP inspections usually every 1 or 2 years for registered facilities depending on risk and inspection history Walk in with a Form 482 and walk out with a Form 483 No findings? No
15 FDA Inspection Tips Be cordial and cooperative, but not too friendly Don t offer information or records that weren t asked for Explain and clarify No arguments or stand-offs just take the hit (you ll do better in the 483 response) Redact any records (copies) they want to take and make a note of what they are 15
16 FDA 483 Response Tips Acknowledge the observation if correct Clarify the situation if incorrect don t say the inspector was wrong If the situation did not represent a risk to donor or patient safety, state this If the situation did not represent lack of control over operational or quality systems, state this Don t give excuses Provide corrective action plan and timeline Describe any corrective action taken so far and plans to monitor for effectiveness 16
17 CLIA 42 CFR Test categorization by complexity - Proficiency testing - Quality system - General laboratory systems (patient confidentiality, specimen identity and integrity, complaints, communications, personnel competency) - Personnel qualifications & responsibilities 17
18 CLIA 42 CFR 493 (continued) Pre-analytical Systems Analytic Systems Post-analytic Systems test request, specimen submission and suitability SOPs, test systems, equipment, reagents, supplies, calibration, validation controls, test records test report 18
19 Where to find it U.S. Code Code of Federal Regulations Federal Register back to 1994 Really OLD Federal Registers and CFRs back to 1930s CBER Guidance Documents Information/default.htm 19
20 Where to find it CLIA stuff CMS Guidance/Legislation/CLIA/index.html?redirect=/clia/ CDC FDA ryassistance/ucm htm New York State Clinical Laboratory Evaluation Program 20
21 Quality 21
22 Quality Quality Control Process Control Quality Assurance Quality Management System 22
23 Elements of a Quality Management System AABB Stds. 29/30 Ed. Organization Resources- HR Equipment Supplier and Customer Issues Assessments : Internal /External Process Improvement through Corrective and Preventive Action Facilities and Safety Process Control Documents and Records Deviations,Nonconformances and Adverse Events 23
24 Elements of a Quality Management System Clinical Laboratory Standards of Practice- Part 1 -General Standards System Quality Management System Human Resources Facility Design /Resource Management Highlights : adequate training, qualifications, compliance program, investigation of non- conformance, quality manual etc. : Lab director/ assistant director time on site, involement roles and responsibilities, education and activities performed, Quality Systems Manager delegated by the Lab Director Adequate space, lighting, backup power for critical systems are controlled and can be recovered, temperature monitoring and environmental monitoring ( as appropriate) sharps, work surface decontamination, LIMS- validation 24
25 Elements of a Quality Management System cont d System SOP and Compliance Clinical Laboratory Standards of Practice- Part 1 -General Standards Pre- Examination Procedures Highlights Standardized format, available at all times to staff at bench. Archiving process for earlier editions, signed and dated prior to implementation by lab director Proper protocol for specimen identification, rejection and retention, disposal protocol, specimen packaging requirements, request form protocol Examination Procedures System in place to evaluate and define relationship between test results every six months ( if perform the same test in multiple sites ), Validation practice plan, summary available ( for after 2 years after method d cd) 25
26 Elements of a Quality Management System cont d System Post Examination Procedures Quality Assessment and Improvement Highlights Interpretation of results, process for errors and inaccuracies in patient reports On going monitors for performance, proficiency testing, referral notification, record retention 26
27 QA: Inputs Process Outputs Select and Qualify SOPs Facilities People Equipment Supplies Reagents Computer Systems 27
28 QA: Inputs Process Outputs Validate & Control QC CAPA SPC Automation Error Proofing CPI Feedback Loop 28
29 QA: Inputs Process Outputs Measure/Inspect Review Records Ask Customer Verify data, Information Inspect Product, Service Review Reports Monitor complaints, failures 29
30 How do we get to high quality products and services? Know what you want Know what your customers want Do it by design Don t skimp when you implement Monitor to make sure Approach improvement like a science experiment 30
31 Emergency Preparedness 31
32 Emergency Preparedness 1. Plan Hazard Identification Mitigation Preparedness Response Recovery Continuity of Operations 2. Coordinate, cooperate, communicate 3. Train, test, and practice 4. Incorporate lessons learned into plan 32
33 Emergency Preparedness Requirements Entity AABB OSHA Regulation /Standard Std 1.4 BB/TS shall have emergency operation policies, processes and procedures to respond to the effects of the internal and external disasters Std the emergency management plan, including emergency communication systems, shall be tested at defined intervals Written plans must be in place for facilities with more than 10 people. 33
34 Emergency Preparedness Lessons Learned - Evacuation Learn how to transfer phones. Keep a doc on hand for patient care issues. Keep an admin support person close by too. 34
35 Emergency Preparedness Lessons Learned - Evacuation Blood irradiators don't have wheels. You may know where you are, but the hospital staff don t unless you tell them. If you ask nicely, not all patients need to be transfused right away. 35
36 Emergency Preparedness Lessons Learned - Evacuation Be clear about what areas need to evacuate large hospitals may be zoned. Find out who s in charge and how you will communicate with that person. 36
37 Emergency Preparedness Lessons Learned - Evacuation What s really useful? Defined emergency team critical players Defined areas of refuge, alternate work sites Reliable communication devices 2-way radios batteries charged know how to use them 37
38 What s really useful to have? Phone numbers key staff, key suppliers (office, cell, text or instant messaging) Land line that doesn t need electricity Shopping list what to take with you Things to consider checklist or decision tree diagram NOT too detailed! 38
39 Emergency Plan in Action What worked Had a plan Emergency response team Rapid notification to hospital staff Designated refuge area What didn t Too much detail Extra people in the way No evening and night shift notification No communications with refuge area 39
40 Emergency Plan in Action What worked Continuation of services plan Alternate work space identified Remote access to major computer systems Emergency contact list for hospital What didn t Ongoing hospital interactions Some critical supplies not available No access to local computer applications Contacts for suppliers 40
41 What about regional events? 9-11 The east coast earthquake Sandy Your plan has to address how to respond if you are in the middle of the disaster, or on the outside and trying to support another blood center or hospital. Transportation and communication will ALWAYS be a challenge. Effective messaging to the PUBLIC and your STAFF is really important. 41
42 Keep asking yourself: Do we still have control? Are we opening the door to errors? Are we taking too many risks? What s in the best interest of our patients? 42
43 Emergency Preparedness Useful websites CDC Emergency Preparedness and Response AABB Disaster Response FEMA 43
Standards, Guidelines, and Regulations
Standards, Guidelines, and Regulations Theresa C. Stec BA, MT(ASCP) Biovigilance Program Manager Surgical System Administrator Perioperative Services Baystate Medical Center Springfield, MA Standards,
More information7 th Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration
7 th Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration Summary of Changes This document summarizes the major changes made
More informationTESTIMONY OF THOMAS HAMILTON DIRECTOR SURVEY & CERTIFICATION GROUP CENTER FOR MEDICAID AND STATE OPERATIONS CENTERS FOR MEDICARE & MEDICAID SERVICES
TESTIMONY OF THOMAS HAMILTON DIRECTOR SURVEY & CERTIFICATION GROUP CENTER FOR MEDICAID AND STATE OPERATIONS CENTERS FOR MEDICARE & MEDICAID SERVICES ON CLIA AND GENETIC TESTING BEFORE THE SENATE SPECIAL
More informationFDA Inspectional Process in Clinical Research An FDA Perspective. Annette Melendez, MPHsN Investigator Office of Biological Products Operations
FDA Inspectional Process in Clinical Research An FDA Perspective Annette Melendez, MPHsN Investigator Office of Biological Products Operations Outline BIMO PROGRAM OVERVIEW PROGRAM COVERED AREAS INSPECTIONAL
More informationList of Policies and Standard Operational Procedures (SOPs) for cell collection, processing and transplantation programmes
Format of SOPs (SOPs) for cell collection, processing and transplantation programmes There must be an SOP covering the procedure of preparing, implementing and revising all procedures and an SOP for document
More informationCertified Healthcare Safety Environmental Services (CHS-EVS) Examination Blueprint/Outline
Certified Healthcare Safety Environmental Services (CHS-EVS) Examination Blueprint/Outline Exam Domains 100-130 1. Safety Management 38-50 (38%) 2. Hazard Control 38-50 (38%) 3. Compliance & Voluntary
More informationThe GCP Perspective on Study Monitoring
The GCP Perspective on Study Monitoring Heidi Judge, CCRP Sr. Clinical Trials Project Manager Clinical Trials Network and Institute Massachusetts General Hospital 1 Overview Monitoring Basics Who, What,
More informationCAP Forensic Drug Testing Accreditation Program Standards for Accreditation
CAP Forensic Drug Testing Accreditation Program Standards for Accreditation Preamble Forensic drug testing is a laboratory specialty concerned with the testing of urine, oral fluid, hair, and other specimens
More informationIQCP. Ensuring Your Laboratory s Compliance With Individualized Quality Control Plans. November/December 2016
IQCP Ensuring Your Laboratory s Compliance With Individualized Quality Control Plans November/December 2016 Objectives Describe the different components of an IQCP Review new CAP checklist requirements
More informationAbout PACT. PACT Members. Production Assistance for Cellular Therapies. October 11, :00 Noon - 1:00 PM ET
Production Assistance for Cellular Therapies Welcome to the PACT Educational Web Seminar October 11, 2007 12:00 Noon - 1:00 PM ET About PACT An NHLBI-funded initiative committed to the advancement of effective
More informationStandards for Laboratory Accreditation
Standards for Laboratory Accreditation 2017 Edition cap.org 2017 College of American Pathologists. All rights reserved. [ T y p e t h e c o m p a n y a d d r e s s ] CAP Laboratory Accreditation Program
More informationCertified Healthcare Safety Long Term Care (CHS-LTC) Examination Blueprint/Outline
Certified Healthcare Safety Long Term Care (CHS-LTC) Examination Blueprint/Outline Exam Domains 100-130 1. Safety Management Principles 31-40 (31%) 2. Hazard Control Concepts 46-60 (46%) 3. Compliance
More informationGOOD LABORATORY PRACTICES (GLP) OVERVIEW
GOOD LABORATORY PRACTICES (GLP) OVERVIEW MN ASQ MEETING - 4/11/17 TERRY RICKE COMPLIANCE / AUDIT SPECIALIST MEDTRONIC PHYSIOLOGICAL RESEARCH LABS TERRY.RICKE@MEDTRONIC.COM WHAT IS GLP? Good Laboratory
More informationPROGRAM GUIDE - UNIVERSITY CLIA REGISTERED LABORATORIES COMPLIANCE COMMITTEE
PROGRAM GUIDE - UNIVERSITY CLIA REGISTERED LABORATORIES COMPLIANCE COMMITTEE 1 P age GUIDELINES - UNIVERSITY CLIA REGISTERED LABORATORIES COMPLIANCE COMMITTEE AND PROGRAM I. Introduction II. Committee
More informationGuide 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:
More informationNational Association of Rural Health Clinics
National Association of Rural Health Clinics A Virtual Walk Through of a Rural Health Clinic October 17, 2017 Kate Hill, RN VP Clinical Services Inc. Tom Terranova Chief Operating Officer Who Is In The
More informationCompounded Sterile Preparations Pharmacy Content Outline May 2018
Compounded Sterile Preparations Pharmacy Content Outline May 2018 The following domains, tasks, and knowledge statements were identified and validated through a role delineation study. The proportion of
More informationRHC COMPLIANCE AND REGULATIONS
RHC COMPLIANCE AND REGULATIONS ROBIN VELTKAMP HEALTH SERVICES ASSOCIATES OBJECTIVES Participants will gain an understanding of the basic Federal RHC Regulations. Participants will gain an understanding
More informationStandards for Forensic Drug Testing Accreditation
Standards for Forensic Drug Testing Accreditation 2013 Edition cap.org Forensic Drug Testing Accreditation Program Standards for Accreditation 2013 Edition Preamble Forensic drug testing is a laboratory
More informationAMERICAN BOARD OF HISTOCOMPATIBILITY AND IMMUNOGENETICS Laboratory Director. Content Outline
1. Administration and Management (40 Items) A. Quality Assurance (16 items) 1. Determine if technical staff has received training and continuing education 2. Select external laboratory proficiency testing
More informationTo: Prefectural Governors From: Director General, Pharmaceutical and Food Affairs Bureau, Ministry of Health, Labour and Welfare
This draft English translation of notification on GLP has been made by JSQA. JSQA translated them with particular care to accuracy, but does not guarantee that there are no differences in the delicate
More informationTRAINING. A. Hazard Communication/Right-to-Know Training
XIII. TRAINING A multitude of training requirements are addressed by OSHA and other safety, health and environmental regulations. A summary of these requirements are presented. A. Hazard Communication/Right-to-Know
More informationPolicy Subject Index Number Section Subsection Category Contact Last Revised References Applicable To Detail MISSION STATEMENT: OVERVIEW:
Subject Objectives and Organization Pathology and Laboratory Medicine Index Number Lab-0175 Section Laboratory Subsection General Category Departmental Contact Ekern, Nancy L Last Revised 10/25/2016 References
More informationEMA Inspection Site perspective
EMA Inspection Site perspective Hermien Gous Wits RHI Shandukani Research Centre 27.09.2016 Cape Town Why were we inspected times? Pharmaceutical company applied for registration of the study drug in a
More informationTake a Course of Action.
Take a Course of Action. When you choose RAPS Online University, you ll be on track to expand your regulatory knowledge and advance your career. Our comprehensive learning provides an immersive experience
More informationSOP WP6-QUAL-04, Version 1.0, 23 February 2014 Page 1 of 8. SOP Title: Laboratory (GCLP) supervision visits
SOP WP6-QUAL-04, Version 1.0, 23 February 2014 Page 1 of 8 SOP Title: Laboratory (GCLP) supervision visits Project/study: NIDIAG: this SOP applies to all NIDIAG clinical studies (WP2). 1. Scope and application
More informationCLIA S NEW IQCP SEABB. March 19, Linda Sigg, MT(ASCP)SBB,CQA(ASQ) Staff Lead Assessor, Accreditation, AABB
CLIA S NEW IQCP SEABB March 19, 2014 Linda Sigg, MT(ASCP)SBB,CQA(ASQ) Staff Lead Assessor, Accreditation, AABB OBJECTIVES Clinical Laboratory Improvement Amendment What is IQCP? What are the parts of IQCP.
More informationPOCKET 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...
More informationThe Safety Audit. Safety Audits Why Bother? Oh no.. 4/26/2017. I need some help but where can I get it????? Does it really matter? I hate metrics!
Safety Audits Why Bother? TriState Histology Symposium 2017 Double Tree Hotel, Rochester, MN May 5, 2017 10:30 am 12:00 pm Patricia J. Hlavka, MS, CSP Oh no.. I ve never done this before! Does it really
More informationStudy Start-Up SS STANDARD OPERATING PROCEDURE FOR PRE-STUDY SITE VISIT (PSSV)
Replaces previous version 203.01: 01 July 2014 Study Start-Up SS 203.01 STANDARD OPERATING PROCEDURE FOR PRE-STUDY SITE VISIT (PSSV) Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature
More informationIs Your Company in Compliance with OSHA Standards for First Aid Training and Emergency Preparedness?
Is Your Company in Compliance with OSHA Standards for First Aid Training and Emergency Preparedness? Find Out How the American Red Cross Can Help. See inside for tips on meeting OSHA Guidelines... www.redcross.org
More informationGuidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA
Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this
More informationNational Marrow Donor Program /Be the Match 23rd Edition Standards And Glossary January 1, 2016 Notice and Disclaimer NMDP/Be the Match Standards
National Marrow Donor Program /Be the Match 23rd Edition Standards And Glossary January 1, 2016 Notice and Disclaimer NMDP/Be the Match Standards These standards apply to activities performed by National
More informationNANCI A. HAYWARD North Springs Drive Dunwoody, Georgia
1595 North Springs Drive Dunwoody, Georgia 30338 404-502-2823 nancihayward@thedragonflysolution.com Summary Over 25 years of team building, goal oriented management, and direct industrial experience using
More informationCAP Most Frequent Deficiencies and How to Avoid Them. March 11, 2015
CAP 2015 Most Frequent Deficiencies and How to Avoid Them Jean Ball MBA,MT(HHS),MLT(ASCP) Inspection Services Team Lead Laboratory Accreditation Program March 11, 2015 Objectives: Participants will be
More informationOrdinance on Good Laboratory Practice (OGLP)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force. Ordinance on Good Laboratory Practice (OGLP) 813.112.1
More informationCLOSE OUT VISIT REPORT (NO CRF TO MONITOR)
Date: Page: 1 of 8 CLOSE OUT VISIT REPORT (NO CRF TO MONITOR) Protocol: PI Name: PI Address: Date of Visit: Monitor(s): Other Sponsor Personnel Present: Site Personnel Present at Visit (include names and
More informationLearning Objectives. Individualized Quality Control Plans. Agenda. Another Way To Determine QC? Hooray!!!! What is QC?
Learning Objectives State when an IQCP is required Individualized Quality Control Plans Andy Quintenz Scientific / Professional Affairs Compare / Contrast Traditional QC approach with Risk Based QC List
More informationPerformance of Point-of-Care Testing in Unaccredited Settings:
Performance of Point-of-Care Testing in Unaccredited Settings: A Guideline for Non-Laboratorians Prepared by the Advisory Committee on Laboratory Medicine College of Physicians & Surgeons of Alberta You
More informationDr. R. Sathianathan. Role & Responsibilities of Principal Investigators in Clinical Trials. 18 August 2015
18 August 2015 Role & Responsibilities of Principal Dr. R. Sathianathan Professor of Psychiatry, SRMC, Porur & Former Director, Institute of Mental Health, Chennai Principal Investigators & GOOD CLINICAL
More informationQuality Medical and Laboratory Practice in Cellular Therapy
Quality Plans: Development and Implementation ISCT Annual Meeting May 24, 2010 Lizette Caballero, B.S., M.T.(ASCP) Laboratory Manager Florida Hospital Cellular Therapy Laboratory Quality Plan: Development
More informationCertified Hazard Control Manager (CHCM) Certified Hazard Control Manager Security (CHCM-SEC) Examination Blueprint/Outline
Certified Hazard Control Manager (CHCM) Certified Hazard Control Manager Security (CHCM-SEC) Examination Blueprint/Outline (Effective October 1, 2017) Exam Domains 145 Items 1. Safety Management 43 Items/30%
More informationClinical Laboratory Standards of Practice
Wadsworth Center Clinical Laboratory Evaluation Program Part 1 General Systems TABLE OF CONTENTS Quality Management System 3 Human Resources 9 Facility Design and Resource Management 23 General Facilities...
More informationUnofficial copy not valid
Page 2 (9) CONTENTS 1. PURPOSE... 3 2. DEFINITIONS... 3 3. RESPONSIBILITY... 3 4. INVESTIGATOR SELECTION... 3 4.1 Identification of Investigator s... 3 4.2 Initial Contacts... 4 4.3 Distribution of Pre-Study
More informationCAP Accreditation and Checklists Update. Lyn Wielgos, MT(ASCP) Checklist Editor, CAP Accreditation Programs
CAP Accreditation and Checklists Update Lyn Wielgos, MT(ASCP) Checklist Editor, CAP Accreditation Programs November 3, 2017 Objectives Discuss CAP Checklists and highlight changes in the 2017 checklist
More informationGeneral Administration GA STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility
General Administration GA 102.01 STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility Approval: Nancy Paris, MS, FACHE President and CEO (17 July 2014) (Signature and
More informationInternal Lab Inspections: Are You Inspection Ready? Presented by: Jeanne Mumford, MT(ASCP) Manager, Point of Care Testing, JHM
Internal Lab Inspections: Are You Inspection Ready? Presented by: Jeanne Mumford, MT(ASCP) Manager, Point of Care Testing, JHM Speaker Introductions Jeanne Mumford, MT(ASCP) Manager, Point of Care Testing
More information3/14/2016. The Joint Commission and IQCP. Objectives. Before Getting Started
The Joint Commission and IQCP Stacy Olea, MBA, MT(ASCP), FACHE Executive Director Laboratory Accreditation The Joint Commission AACC 2015 Objectives Identify the three components of IQCP Determine a starting
More informationLaboratory Assessment Tool
WHO/HSE/GCR/LYO/2012.2 Laboratory Assessment Tool Annex 1: Laboratory Assessment Tool / System Questionnaire April 2012 World Health Organization 2012 All rights reserved. The designations employed and
More informationTomoko OSAWA, Ph.D. Director for GCP Inspection Office of Conformity Audit PMDA, Japan
Tomoko OSAWA, Ph.D. Director for GCP Inspection Office of Conformity Audit PMDA, Japan The views presented in this presentation are those of the author and should not be understood or quoted as being made
More informationEmergency Preparedness
Emergency Preparedness Emergency Preparedness On September 16, 2016 the final rule on Emergency Preparedness requirements for Medicare and Medicaid participating providers and suppliers was published.
More informationCLIA Regulations Update 2015
Regulations Update 2015 1 KAREN DYER MT(ASCP), DLM ACTING DIRECTOR DIVISION OF LABORATORY SERVICES CENTERS FOR MEDICARE&MEDICAID SERVICES Learning Objectives Understand the impact of the Patient Access
More informationIndividualized Quality Control Plan (IQCP) Frequently Asked Questions Date: May 5, 2015 (last updated 08/21/2017)
Topic: Individualized Quality Control Plan (IQCP) Frequently Asked Questions Date: May 5, 2015 (last updated 08/21/2017) Click on the links below to be taken to a specific section of the FAQs. General
More informationCE Update [generalist compliance/regulation management/administration and training] COLA Accreditation An Educational Experience
your lab focus 284 CE Update [generalist compliance/regulation management/administration and training] COLA Accreditation An Educational Experience Jennifer L. Rivers, Catherine M. Johnson, MT(ASCP) COLA,
More informationStandards for Biorepository Accreditation
Standards for Biorepository Accreditation 2013 Edition cap.org Biorepository Accreditation Program Standards for Accreditation 2013 Edition Preamble A biorepository is an entity that receives, stores,
More informationPRE-INSPECTION QUESTIONNAIRE INSTRUCTIONS
PRE-INSPECTION QUESTIONNAIRE INSTRUCTIONS! Submit copies of all documents or records outlined below. If you do not have the required information, indicate whether or not you expect to have it at the time
More informationASHE Resource: Implications of the CMS emergency preparedness rule
CMS EMERGENCY PREPAREDNESS RULE TEXT 482.15 Condition of participation: Emergency preparedness. The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements.
More informationSTANDARDS Point-of-Care Testing
STANDARDS Point-of-Care Testing For Surveys Starting After: January 1, 2018 Date Generated: January 12, 2017 Point-of-Care Testing Published by Accreditation Canada. All rights reserved. No part of this
More informationEmergency Preparedness: Preserving Your Life s Work
Emergency Preparedness: Preserving Your Life s Work University of Miami Miller School of Medicine & UHealth Department of Public Safety www.publicsafety.med.miami.edu Office of Research, Research Education
More informationCertified Healthcare Safety Professional (CHSP) Examination Blueprint/Outline
Certified Healthcare Safety Professional (CHSP) Examination Blueprint/Outline (Effective October 1, 2017) Exam Domains 150 Items 1. Safety Management A. Leadership & Management (14 Items/9%) B. Safety
More informationBIMO Program Update an operational perspective
BIMO Program Update an operational perspective Clinical Trials Summit San Juan, Puerto Rico May 9, 2018 Anne E. Johnson Program Division Director FDA/ORA/OBIMO Division I (East) 1 Objectives Program Alignment
More informationEMA & FDA Inspections: Site perspective. Shandukani Research Centre
EMA & FDA Inspections: Site perspective Shandukani Research Centre Why were we inspected? Pharmaceutical company applied for registration of the study drug (Phase I/II dosing studies in paediatrics) Large
More informationThe CAP Inspection Process
The CAP Inspection Process So you ve accepted an inspection assignment Inspector s Inspection Packet sent from CAP 3 6 months prior to lab s anniversary date Inspection must occur within 3 month window
More informationChanges to QSR. The table below provides a history of changes to FDA s Quality System Regulation (QSR)
Changes to QSR The table below provides a history of changes to FDA s Quality System Regulation (QSR) The citation is to the Federal R: the first number is the volume, FR indicates the Federal Register,
More informationCrosswalk of Regulations And Guidance Affecting Laboratories Sorted by QSE. May 2017
Crosswalk of Regulations And Guidance Affecting Laboratories Sorted by QSE May 2017 Introduction This crosswalk of regulatory references is arranged by Quality System Essentials (QSEs), the fundamental
More informationEMERGENCY PREPAREDNESS ACUTE CARE
Medicare and Medicaid Programs; Emergency Preparedness; Requirements for Medicare and Medicaid Participating Providers and Suppliers 42 CFR 482.15 Published September 16, 2016; Effective November 15, 2016;
More informationA COLA White Paper: FEDERAL GOVERNMENT QUESTIONS QUALITY IN WAIVED TESTING.
A COLA White Paper: FEDERAL GOVERNMENT QUESTIONS QUALITY IN WAIVED TESTING. Executive Summary Laboratory testing plays a critical role in the healthcare system, impacting about 70 percent of all diagnostic
More informationNLTC-9. Supporting Your Sentinel Laboratories
NLTC-9 Supporting Your Sentinel Laboratories Rob Nickla, BT/CT LRN Coordinator, STC, RO Oregon State Public Health Laboratory Outline Communication & Relationships State Specifics Sentinel Laboratory Site
More informationEffective Date: April 2014 Revision: September 29, Executive Chair, Co-Chairs, NSHA REB Members, REB Office Personnel, Researchers.
TITLE: Standard Operating Procedure (SOP) External Inspections or Audits NUMBER: NSHA REB-SOP-9-002 Effective Date: April 2014 Revision: September 29, 2017 Applies To: Executive Chair, Co-Chairs, NSHA
More informationGCP INSPECTION CHECKLIST
(This list is not all inclusive; item may be added &/or deleted as per the Study/Site/Sponsor/Lab) I. General. Name and address of the clinical trial site Tel. No. & e- mail:. Date of Inspection. Inspection
More informationmanaging or activities.
STANDARD OPERATING PROCEDURE Clinical Research Monitoring TITLE: Site Initiation Visit TITLE: Site Initiation Visit 1. PURPOSE SOP Number: Version: 1.0 MICHR CRM MON 002 Effective Date: 19Dec2013 1.1 This
More informationGuidance for MRC units on HTA licence applications for storage of human samples for research purposes
Guidance for MRC units on HTA licence applications for storage of human samples for research purposes Summary In England, Wales and Northern Ireland the Human Tissue Authority (HTA) is licensing premises
More informationClinical Research Professionals
Training & Resources for Clinical Research Professionals Course & Publications Catalog January July 2016 In-Person and Web-Based Training Courses, Customized Training, elearning and Publications for Clinical
More informationHome Health Agency Requirements CMS Emergency Preparedness Final Rule
Home Health Agency Requirements CMS Emergency Preparedness Final Rule The Centers for Medicare & Medicaid Services (CMS) issued the Emergency Preparedness Requirements for Medicare and Medicaid Participating
More informationMODULE 22: Contingency Planning and Emergency Response to Healthcare Waste Spills
MODULE 22: Contingency Planning and Emergency Response to Healthcare Waste Spills Module Overview Present examples of contingencies related to HCWM Describe steps in developing a contingency plan Describe
More informationSolutions for GCP Compliance Challenges. September 23, 2015 Northwestern University IRB Brown Bag Session
Solutions for GCP Compliance Challenges September 23, 2015 Northwestern University IRB Brown Bag Session PAMELA MASON, MPH Vice President, Mason Professional Services, LLC Adjunct Faculty, Northwestern
More informationSolutions for GCP Compliance Challenges
Solutions for GCP Compliance Challenges September 23, 2015 Northwestern University IRB Brown Bag Session PAMELA MASON, MPH Vice President, Mason Professional Services, LLC Adjunct Faculty, Northwestern
More informationSANTA RITA CARE CENTER Notice of Information Practices
SANTA RITA CARE CENTER Notice of Information Practices THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT
More informationCatholic Health Initiatives
Lessons Learned Implementing a Laboratory Compliance Program in a National Healthcare System March 2014 Tim Murray MS, MT(ASCP) CHC Director of Laboratory Compliance Catholic Health Initiatives Denver,
More informationShawnee State University
Shawnee State University AREA: ACADEMIC AFFAIRS POLICY NO.: 5.21 ADMIN. CODE: 3362-5-22 PAGE NO.: 1 OF 13 EFFECTIVE DATE: 6 / 1 8 / 9 3 RECOMMENDED BY: A.L. Addington SUBJECT: BLOODBORNE PATHOGENS APPROVED
More informationCOMMISSION ON LABORATORY ACCREDITATION. Laboratory Accreditation Program TEAM LEADER ASSESSMENT OF DIRECTOR & QUALITY CHECKLIST
Revised: 09/27/2007 COMMISSION ON LABORATORY ACCREDITATION Laboratory Accreditation Program TEAM LEADER ASSESSMENT OF DIRECTOR & QUALITY CHECKLIST Disclaimer and Copyright Notice The College of American
More information2016 APHL BIOSAFETY AND BIOSECURITY SURVEY
2014 APHL All Hazards Laboratory Preparedness Survey 2016 APHL BIOSAFETY AND BIOSECURITY SURVEY February 2016 Introduction 2016 APHL Biosafety and Biosecurity Survey Welcome to the 2016 APHL Biosafety
More informationDocumenting the Story of a Clinical Trial: Concept to CAPA. Lori T. Gilmartin Gilmartin Consulting LLC
Documenting the Story of a Clinical Trial: Concept to CAPA Lori T. Gilmartin Gilmartin Consulting LLC The regulations represent the floor while ethical thinking is the sky. Dr. Thomas Moore Boston University
More informationImproving Your POC Program: An Upside Down Map. Sheila K. Coffman MT(ASCP)
Improving Your POC Program: An Upside Down Map Sheila K. Coffman MT(ASCP) If you have seen ONE Point of Care program You have seen ONE Point of Care Program. If only there was a MapQuest for POC... Or
More informationOrganization for Economic Co-operation and Development
IGLP document -IRAQ- BAGHDAD English - Or. Arabic Unclassified Organization for Economic Co-operation and Development (2015) 21-Dec-2015 According to criteria of OECD ON TESTING AND CALIBRATION Number
More informationCELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION DOCUMENT SUBMISSION REQUIREMENTS
CELLULAR THERAPY PRODUCT COLLECTION, PROCESSING, AND ADMINISTRATION DOCUMENT SUBMISSION REQUIREMENTS FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration,
More informationJob Description. TDL Laboratory Staff, Clients and Customers, Group Blood Transfusion Manager
Job Description Job Title: Location: Reporting to: Accountable to: Liaises with: Senior Biomedical Scientist (Blood Transfusion) BMI London Independent Pathology Lead Group Laboratory Director Regional
More informationAuthorized Personnel to Review
October 31, 2017 Page 1 of 7 All documents developed or maintained for the Manufactured Food Regulatory Program Standards ( MFRPS ) are listed below. For each document, the following information is included:
More informationContact Hours FL (CE version ONLY) Suggested Target Audience. staff that provide care to patients. Page 1 of 8 Updated: 10/30/2017
PA CE 1 Active Shooter Response in Healthcare Settings - An HCCS Regulatory 1/8/2016 1 1 N/A 20 N/A N/A all staff 2 Advance Directives - An HCCS Regulatory 10/15/2015 1 1 N/A 54 N/A N/A all staff 3 Annual
More informationREGULATORY & ACCREDITING AGENCIES
REGULATORY & ACCREDITING AGENCIES OBJECTIVES Describe the differences between an accrediting agency and a regulatory agency Articulate the differences in standards, regulations, guidelines, and their impact
More informationBLOODBORNE PATHOGENS
BLOODBORNE PATHOGENS Supplement to Standard Training Module TRAINING REQUIREMENTS OVERVIEW This standard Vivid training module provides a general overview of Bloodborne Pathogens (BBP). It is important
More informationNN SS 401 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR SITE SELECTION AND QUALIFICATION
NN SS 401 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR SITE SELECTION AND QUALIFICATION SOP: NN SS 401 Version No.: 2.0 Effective Date: 21Oct2016 SITE SELECTION AND QUALIFICATION Supercedes Document:
More informationClinical Trial Quality Assurance Common Findings
Clinical Trial Quality Assurance Common Findings Objectives Identify common findings found in research study reviews conducted by the CTQA Program Understand what findings require an action plan vs. a
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Routine Project Audit SOP Number: 6 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August
More informationCreating An Effective OSHA Compliance Program
Presents Creating An Effective OSHA Compliance Program Bloodborne Pathogens and Your Course Faculty R. Thomas (Tom) Loughrey, MBA, CCS-P Chairman, CEO & Co-Founder of Economedix Certified Coding Specialist
More informationMAHONING COUNTY PUBLIC HEALTH EMERGENCY RESPONSE PLAN DISTRICT BOARD OF HEALTH MAHONING COUNTY YOUNGSTOWN CITY HEALTH DISTRICT
MAHONING COUNTY PUBLIC HEALTH EMERGENCY RESPONSE PLAN MAHONING COUNTY EMERGENCY OPERATIONS PLAN: ANNEX H DISTRICT BOARD OF HEALTH MAHONING COUNTY YOUNGSTOWN CITY HEALTH DISTRICT PUBLIC HEALTH PREPAREDNESS
More informationLaboratory Risk Assessment: IQCP and Beyond. Ron S. Quicho, MS Associate Project Director Standards and Survey Methods, Laboratory July 18, 2017
Laboratory Risk Assessment: IQCP and Beyond Ron S. Quicho, MS Associate Project Director Standards and Survey Methods, Laboratory July 18, 2017 Objectives Explain the importance of risk assessment in the
More informationNational Blood Transfusion Service Policy
Swaziland Government National Blood Transfusion Service Policy A Draft November 30, 2010 Ministry of Health P.O. Box 5 Mbabane, Swaziland Page 1 of 21 Table of Contents List of Acronyms Foreword Chapter
More information6/28/2016. Questions? Workshop 6 CAP Inspection Preparation Thursday, June 23, 2016
Workshop 6 CAP Inspection Preparation Thursday, June 23, 2016 Allan W. Fraser Jr., CG(ASCP)CM, CCS, CQA(ASQ) Quality Assurance Manager, Quest Diagnostics at Nichols Institute Questions? Have you been inspected
More informationThe CLIA regulations..
Julia H. Appleton MT(ASCP), MBA Centers for Medicare & Medicaid Services (CMS) Center for Clinical Standards and Quality (CCSQ) Division of Laboratory Services (DLS) April 13, 2017 Objectives Explain an
More information