Best Practices for Equipment Calibration and Analytical Controls in the Diagnostics Laboratory
|
|
- Wesley Hampton
- 5 years ago
- Views:
Transcription
1 Best Practices for Equipment Calibration and Analytical Controls in the Diagnostics Laboratory George Rodrigues, Artel (slides 2-16) Rebecca Butler, CareDx (slides 17-29)
2 Agenda Agenda Theory / Regulations Applications Discussion
3 Liquid handling quality assurance Metrology - the science of measuring things Documentary standards - best practices
4 Analytical Controls
5 Equipment Calibration
6 Public Laws Congress Food, Drug & Cosmetics Act Clinical Laboratory Improvement Amendments (CLIA 88)
7 Federal Regulations CFR Code of Federal Regulations 42 CFR Part 493 Clinical- CLIA 21 CFR Part 820 GMP- In vitro Also know as the QSR, Quality System Requirements.
8 Program Requirements College of American Pathologists CAP Clinical Pathology Accreditation - CPA (UK) Local Quality System Requirements
9 Consensus Standards & Guides International Organization for Standardization - ISO iso.org ISO 15189; ISO ASTM International astm.org Many equipment standards Clinical and Laboratory Standards Institute clsi.org/standards Practices, guides, etc.
10 Key Calibration Requirements for IVD Makers - 21 CFR Inspection, measuring, and test equipment (b) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device s quality. These activities shall be documented. (1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard. (2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
11 Best Practices for Pipette Quality Assurance Calibration Work Flow Record 21 CFR Schedule Calibration 21 CFR Perform As Found Calibration 21 CFR Fail Calibration Alert Remedial Action 21 CFR (4) Corrective Maintenance/ Repair Pass Preventive Maintenance Record 21 CFR Perform As Left Calibration 21 CFR Fail Adjustment/ Corrective Maintenance Pass Return to Service
12 Best Practices for Pipette Quality Assurance Why Calibrate? Ensure performance is acceptable within the required tolerance limits for intended use Comply with regulations Save time Save money Defend data integrity
13 Best Practices for Pipette Quality Assurance Interim Verification / Checks Verify Calibration to for Peace of Mind Prior to Critical Work According to a Designated Schedule After Potentially Damaging Activity Maintain Records
14 Key Calibration Requirements for IVD Makers - 21 CFR 42 CFR Enrollment and testing of samples Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria of this part and is approved by HHS. For each specialty, subspecialty and analyte or test, participate for one year before changing program. The laboratory must test the samples in the same manner as patients' specimens. The samples must be tested with the regular patient workload by personnel who routinely perform the testing. The laboratory must test samples the same number of times that it routinely tests patient samples. Laboratories must not engage in Inter-laboratory communications pertainent to the results of proficiency testing samples, prior to reporting results. What if no approved PT program is available?
15 Key Calibration Requirements for IVD Makers - 21 CFR 42 CFR Evaluation of PT performance The laboratory must verify the accuracy of Any analyte or subspecialty that is not evaluated or scored by a CMSapproved proficiency testing program. At least twice annually, the laboratory must verify the accuracy of the following: Any test or procedure it performs that is not included in (PT program)
16
Policy 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 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 informationMedicare Program; Announcement of the Reapproval of the Joint Commission as an
This document is scheduled to be published in the Federal Register on 05/25/2018 and available online at https://federalregister.gov/d/2018-11330, and on FDsys.gov [Billing Code: 4120-01-P] DEPARTMENT
More informationCLIA s New IQCP Requirements Are in Effect, or Are They?: Implementing Laboratory Risk Management Now to Ensure Success
CLIA s New IQCP Requirements Are in Effect, or Are They?: Implementing Laboratory Risk Management Now to Ensure Success Jack Zakowski, PhD, FACB Director, Scientific Affairs and Professional Relations
More informationMedicare Program; Announcement of the Approval of the American Association for
This document is scheduled to be published in the Federal Register on 03/23/2018 and available online at https://federalregister.gov/d/2018-05892, and on FDsys.gov BILLING CODE 4120-01-P DEPARTMENT OF
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 information2015 OAP Pathologist Assistant Meeting, September 19 - Niagara Falls, Ontario. EQA and the Grosslab Alan Wolff, PA, MLT. Quality in the Gross Lab
Quality in the Gross Lab Lakeridge Health, Oshawa, Ontario Describe what EQA is Describe the IQMH position and requirement Be aware of the current state of EQA for grossing Have identified good methods
More informationUS ): [42CFR ]:
GEN.53400 Section Director (Technical Supervisor) Qualifications/Responsibilities Phase II Section Directors/Technical Supervisors meet defined qualifications and fulfill the expected responsibilities.
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 informationAccreditation of Clinical Laboratories
Accreditation of Clinical Laboratories Symposium on Traceability in Laboratory Medicine 9-11 June 2002 BIPM, Sèvres, France Alan Squirrell, ILAC Executive Regina Robertson, NATA, Australia Sean Peters,
More informationCAP Companion Society Meeting at USCAP 2009 Quality Assurance, Error Reduction, and Patient Safety in Anatomic Pathology
CAP Companion Society Meeting at USCAP 2009 Quality Assurance, Error Reduction, and Patient Safety in Anatomic Pathology Core Components of a Comprehensive Quality Assurance Program in Anatomic Pathology
More informationPoint of Care Quality Management. Procedure. Approving Authority: President and CEO, Keith Dewar
Subject/Title Point of Care Quality Management Procedure Approving Authority: President and CEO, Keith Dewar Manual: Reference Number: 812-1 Effective Date: Dec 6 th, 2016 Revision Dates: Classification:
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 informationGuidance on Quality Management in Laboratories
Guidance on Quality Management in Laboratories series QULAITY IBMS 1 Institute of Biomedical Science Guidance on Quality Management in Laboratories As the UK professional body for biomedical science the
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 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 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 informationPersonnel. From RLM, COM, GEN and TLC Checklists
Personnel From RLM, COM, GEN and TLC Checklists The laboratory should have an organizational plan, personnel policies, and job descriptions that define qualifications and duties for all positions. Personnel
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 informationHeart of America POC Group Quality Management Making it Meaningful
Heart of America POC Group Quality Management Making it Meaningful Maximize Your Existing Quality Management System to Deliver Greater Value Georgine Paulus, BSMT(ASCP) Senior Staff Inspector College of
More informationRichard Haggas Blood Transfusion Quality Manager Leeds Teaching Hospitals NHS Trust
Richard Haggas Blood Transfusion Quality Manager Leeds Teaching Hospitals NHS Trust MHRA Oversees compliance with Blood safety and quality regulations Annual compliance report submitted by each transfusion
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 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 informationWhat s New and Improved for the Laboratory Program in 2013 April 23, 2013
What s New and Improved for the Laboratory Program in 2013 April 23, 2013 John Gibson MA, MT(ASCP), DLM Associate Director Standards Interpretation Group Stacy Olea MBA, MT(ASCP), FACHE Field Director
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 informationTutorial: Basic California State Laboratory Law
Tutorial: Basic California State Laboratory Law This document is meant to cover basic elements of state laboratory law and should not be relied upon in place of legal advice or the official codes of California.
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 informationEDUCATIONAL COMMENTARY KEY COMPONENTS OF AN INDIVIDUALIZED QUALITY CONTROL PLAN
Commentary provided by: E Susan Cease MT(ASCP) Laboratory Manager Three Rivers Medical Center Grants Pass, OR EDUCATIONAL COMMENTARY KEY COMPONENTS OF AN INDIVIDUALIZED QUALITY CONTROL PLAN Educational
More informationContent Sheet 11-1: Overview of Norms and Accreditation
Content Sheet 11-1: Overview of Norms and Accreditation Role in quality management system Assessment is the means of determining the effectiveness of a laboratory s quality management system. Standards,
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 informationCenters for Medicare and Medicaid Services (CMS) Survey and Certification Group (SCG) Mission:
CLIA Presentation The Committee on the Return of Results of Individual- Specific Research Results Generated in Research Laboratories The National Academies of Sciences, Engineering, and Medicine July 19,
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 informationPURPOSE: This policy provides an overview of SHANDS Jacksonville Laboratory s commitment to the care and safety of the patients we serve.
PAGE 1 of 5 TITLE: Provision of Care Regarding Laboratory Services PURPOSE: This policy provides an overview of SHANDS Jacksonville Laboratory s commitment to the care and safety of the patients we serve.
More informationSUCCESSION PLANNING: FILLING A LABORATORY DIRECTOR S SHOES PART ONE
JANUARY / FEBRUARY 09 SUCCESSION PLANNING: FILLING A LABORATORY DIRECTOR S SHOES PART ONE By Karen Appold When someone leaves a laboratory director position, or any job for that matter, it could be for
More informationPathology Quality Review : Outcomes and Update
Pathology Quality Review : Outcomes and Update Dr Ian Barnes UK NEQAS (H) 17 th Annual Meeting National Motorcycle Museum Tuesday 14 th October, 2014 The Review Launched January 28 th, 2014. (england.pathqareview@nhs.net)
More informationStandards, 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 informationQuality assurance in medical laboratories
Quality & Safety Laboratory medicine Quality assurance in medical laboratories Paths to global competence standards Prof. Dr. Egon Amann Hamm-Lippstadt University of Applied Sciences, Germany 50 www.q-more.com/en/
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 informationSOUTH EASTERN TRUST. Point of Care Testing (POCT) Policy Ellie Duly, Chair POCT Committee. Approval date: Operational Date: November 2014
Policy Code: SET/PtCtCare (186) 2014 SOUTH EASTERN TRUST Title: Author(s) Point of Care Testing (POCT) Policy Ellie Duly, Chair POCT Committee Ownership: Approval by: South Eastern Trust Ratified Directors
More informationHOSPICE CONTRACTING CHECKLIST FOR INPATIENT SERVICES, RESPITE CARE AND VENDOR AGREEMENTS
HOSPICE CONTRACTING CHECKLIST FOR INPATIENT SERVICES, RESPITE CARE AND VENDOR AGREEMENTS The following checklist can be used to verify that the regulatory requirements are addressed in hospice contracts
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 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 informationFrequently Asked Questions (FAQs) regarding ISO/IEC 17025:2017 and the transition of accreditation from the previous version of the Standard
Frequently Asked Questions (FAQs) regarding ISO/IEC 17025:2017 and the transition of accreditation from the previous version of the Standard Issue Date: 10 July 2018 General Questions 1. When was the new
More informationIN THE GENERAL COURT OF JUSTICE SUPERIOR COURT DIVISION. ORDER FOR DISCLOSURE OF SBI and NC HIGHWAY PATROL TESTING DATA
FILE NUMBERS: 09-CRS- FILM NUMBER: NORTH CAROLINA PITT COUNTY IN THE GENERAL COURT OF JUSTICE SUPERIOR COURT DIVISION STATE OF NORTH CAROLINA } } vs. } } CARLA JANE DOE } Defendant } ORDER FOR DISCLOSURE
More informationDaralyn Hassan, MS, MT(ASCP) April 3rd, 2014 CLIA
Daralyn Hassan, MS, MT(ASCP) April 3rd, 2014 General overview of Identification of types of certificates, focusing on the certificate for providerperformed microscopy (PPM) procedures Identification of
More information(i) That individual is competent to provide nursing and nursing related services; and
483.75 Administration. A facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial
More informationThe Future is Now: Global Application of CLSI and ISO:15189 Quality Management Systems
The Future is Now: Global Application of CLSI and ISO:15189 Quality Management Systems Executive War College May 5, 2009 Glen Fine, MS, MBA Executive Vice President, CLSI Key Discussion Points Upon completion
More informationQuality Laboratory Practice and its Role in Patient Safety
Quality Laboratory Practice and its Role in Patient Safety (Policy Number 06-01) Policy Statement ASCP supports the development and maintenance of high quality practice standards for laboratory testing
More informationAdministrative 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
More informationAdult Family Care Home Top Ten Health Deficiency Citations Statewide October 8, 2009 Year Date Range: January 1, 2008 through December 31, 2008
Rank Tag Count Description Adult Family Care Home 1 F0401 182 Personnel records must include verification of freedom from communicable disease for the AFCH provider, each relief person, each adult household
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 informationCollege of American Pathologists. Senior Director, Legislation and Political Action Position Profile October 2012
College of American Pathologists Senior Director, Legislation and Political Action Position Profile October 2012 This profile provides information about the College of American Pathologists (CAP) and the
More informationTITLE: POINT OF CARE TESTING
San Francisco General Hospital and Trauma Center Administrative Policy Policy Number: 16.20 TITLE: POINT OF CARE TESTING DEFINITIONS 1. Point of Care Testing (POCT) refers to laboratory testing performed
More informationCLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988: HOW TO ASSURE QUALITY LABORATORY SERVICES
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988: HOW TO ASSURE QUALITY LABORATORY SERVICES OVERVIEW In response to public health concerns over largely unregulated laboratory services, Congress enacted
More informationBureau of Clinical Laboratories Quality Assessment Plan
Bureau of Clinical Laboratories Quality Assessment Plan THE ALABAMA DEPARTMENT OF PUBLIC HEALTH BUREAU OF CLINICAL LABORATORIES Title Page I. Quality Assessment Plan... 1 II. Goals of the Quality Assessment
More informationASSEMBLY BILL No. 940
california legislature 2015 16 regular session ASSEMBLY BILL No. 940 Introduced by Assembly Member Ridley-Thomas February 26, 2015 An act to amend Sections 1209, 1260, 1261.5, 1264, and 1300 of the Business
More informationPERSONNEL REQUIREMENTS. March 9, 2018
Seema Verma Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building 200 Independence Avenue, S.W., Room 445 G Washington, DC 20201 RE:
More informationTopic: CAP s Legislative Proposal for Laboratory-Developed Tests (LDT) Date: September 14, 2015
Topic: CAP s Legislative Proposal for Laboratory-Developed Tests (LDT) Date: September 14, 2015 1. What are the CAP s views on the regulatory oversight of laboratory-developed tests (LDTs)? 2. How are
More informationDominic Cox Royal Free Hospital London Joan Pearson Leeds General Infirmary
POINT OF CARE TESTING (POCT) IN CRITICAL CARE Authors: Dominic Cox Royal Free Hospital London Joan Pearson Leeds General Infirmary In collaboration with ICS standards committee Introduction Point of Care
More informationC A L I F O R N I A L A B O R AT O RY P E R S O N N E L
C A L I F O R N I A L A B O R AT O RY P E R S O N N E L Shiu-Land Kwong, CLS Regional Director of Lab Compliance & Risk Management The Permanente Medical Group Speaker Shiu-Land Kwong, CLS, is the Regional
More informationOrganisation of a Clinical Laboratory. Peter O Loughlin SA Pathology
Organisation of a Clinical Laboratory Peter O Loughlin SA Pathology AACB Curriculum 5. Laboratory Management (a) Organisation of a Clinical Laboratory (FAACB) Hospital Management Structure and the Clinical
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 informationACCREDITATION REQUIREMENTS
ACCREDITATION REQUIREMENTS Prepared by: Technical Manager Approved by: Chief Executive Officer Approval Date: 2017-08-10 Effective Date: 2017-08-10 Table of Contents 1. PURPOSE AND SCOPE... 3 2. COMPLIANCE
More informationEPEAT Requirements of PREs
EPEAT Requirements of PREs Published 26 January 2015 By The Green Electronics Council EPEAT Requirements of PREs Page 1 Context This EPEAT Requirements of PREs document is part of a set of documents that
More informationAPPLICATION FOR HISTOCOMPATIBILITY LABORATORY MEMBERSHIP ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN)
APPLICATION FOR HISTOCOMPATIBILITY LABORATORY MEMBERSHIP ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN) UNOS 700 North 4 th Street Richmond, VA 23219 Main Phone: 804-782-4800 Name of Histocompatibility
More informationNZS/ISO 15189:2007. Medical Laboratories Particular Requirements for Quality and Competence NZS/ISO 15189:2007
Medical Laboratories Particular Requirements for Quality and Competence (A New Zealand adoption of ISO 15189:2007) NZS/ISO 15189:2007 Committee Representation Committee P 15189, Medical laboratories Quality
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 informationCenter for Medicaid and State Operations/Survey and Certification Group
DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop S2 12 25 Baltimore, Maryland 21244 1850 Center for Medicaid and State Operations/Survey
More informationFDA'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
More informationPREVENT YOUR DIETARY SUPPLEMENT LABORATORY FROM BECOMING A COMPLIANCE RISK. Marian Boardley 2013
PREVENT YOUR DIETARY SUPPLEMENT LABORATORY FROM BECOMING A COMPLIANCE RISK Marian Boardley 2013 APPLICABLE GMP S: DIETARY SUPPLEMENT LABS Subparts for laboratory operations and testing, 21 CFR 111 D Equipment
More informationMassachusetts General Hospital Point of Care Testing Program
Title: POCT Program description Cross References: POCT Program Massachusetts General Hospital - Pathology Service 55 Fruit Street, Boston, MA 02114 Massachusetts General Hospital Point of Care Testing
More informationQuality Assurance Program For Hospital Based Point of Care Testing. Presented by: Jeanne Mumford, MT(ASCP) Pathology Supervisor, QA Specialist
Quality Assurance Program For Hospital Based Point of Care Testing Presented by: Jeanne Mumford, MT(ASCP) Pathology Supervisor, QA Specialist 1 Objectives At the end of the session, participants will be
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 informationMaster. Point-of-Care-Testing Checklist. CAP Accreditation Program
Master Point-of-Care-Testing Checklist CAP Accreditation Program College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 08.17.2016 2 of 33 Disclaimer and Copyright Notice
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 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 informationTITLE 252. DEPARTMENT OF ENVIRONMENTAL QUALITY CHAPTER 302. FIELD LABORATORY ACCREDITATION
Codification through the 2014 Legislative session. Subchapter 9 Board adoption - November 13, 2013 Approved by Governor's declaration on June 19, 2014 Effective date - September 12, 2014 TITLE 252. DEPARTMENT
More informationFLSA Classification: Non-Exempt
Job Description Job Details Title: Section Head, Laboratory Version #: 1.0 Employer: Mercy Hospital Job Code: W29 FLSA Classification: Non-Exempt Pay Grade: W Basic Job Function and Responsibilities Perform
More informationhttps://e-dition.jcrinc.com/common/popups/printchapter.aspx?rwndrnd=
Page 1 of 9 Effective ate: January 9, 2017 Overview: A laboratory test is an activity that evaluates a substance(s) removed from a human body and translates that evaluation into a result. A result can
More informationThe Lab General Checklist
The Lab General Checklist Lab General 129 potential pages of fun! Customized to your lab and lab services so probably more like 50 for RLAP. The Laboratory General (GEN) Checklist applies to all sections
More informationRequest for Information: Revisions to Personnel Regulations, Proficiency Testing
This document is scheduled to be published in the Federal Register on 01/09/2018 and available online at https://federalregister.gov/d/2017-27887, and on FDsys.gov DEPARTMENT OF HEALTH AND HUMAN SERVICES
More informationHIC Standard Operating Procedure. For-Cause Audits of Human Research Studies
HIC Standard Operating Procedure For-Cause Audits of Human Research Studies Background As part of the Wayne State University (WSU) Human Investigation Committee s (HIC) Human Research Protection Program,
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 informationNZQA course. Perform urine drug screening in the workplace. UNIT STANDARD: US Urine drug screening in the workplace. Standard setting body (SSB)
NZQA course Perform urine drug screening in the workplace Susan Nolan & Associates Ltd Susan Nolan & A s s o c i a t e s L t d P r o g r a m m e s f o r S a f e r P l a c e s UNIT STANDARD: US 25511 Urine
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 informationThe CLSI Consensus Process: Making a Difference in Health Care David Sterry, MT(ASCP) Director, Standards Development, CLSI
The CLSI Consensus Process: Making a Difference in Health Care David Sterry, MT(ASCP) Director, Standards Development, CLSI Today s Topics and Goals Introduction to CLSI The consensus process: a primer
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 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 informationVALUE ANALYSIS TEAM POLICY
VALUE ANALYSIS TEAM POLICY PURPOSE The purpose of this policy is to define the structure and operation of the Value Analysis Team (VAT) process, through active participation, facilitation, and support
More informationPoint of Care Testing Clinical Practice Standard and Policy (LTR31449) Version: 2.01
Page 1 of 15 Purpose: To ensure that point-of-care (decentralized) laboratory testing is high quality and cost-effective, in order to contribute to optimal patient care within Vancouver Coastal Health
More informationWhich QMS Standard should be chosen for the structural quality of a medical laboratory? Matthias ORTH
Which QMS Standard should be chosen for the structural quality of a medical laboratory? Matthias ORTH IFCC Committee on Clinical Laboratory Management - http://www.ifcc.org/ifcc-education-division/emd-committees/c-clm/
More informationRECOMMENDATIONS FOR ON-SITE VISITS BY PEERS AND SELECTION CRITERIA FOR ON-SITE VISIT PEER REVIEWERS
RECOMMENDATIONS FOR ON-SITE VISITS BY PEERS AND SELECTION CRITERIA FOR ON-SITE VISIT PEER REVIEWERS 1 Introduction A Mutual Recognition Arrangement (CIPM MRA) was drawn up by the International Committee
More informationSupervision of Biomedical Support Staff (Assistant and Associate Practitioners)
Supervision of Biomedical Support Staff (Assistant and Associate Practitioners) series IBMS 1 Institute of Biomedical Science Supervision of Biomedical Support Staff (Assistant and Associate Practitioners)
More informationRoyal Wolverhampton Hospitals NHS Trust. Job Description Haematology
Royal Wolverhampton Hospitals NHS Trust Job Description Haematology Job Title: Grade: A4C Band 3 (Point 7) Directorate: Pathology Department: Haematology Reports to: BMS staff and section senior Professionally
More information8: : : : : : : : : : :
CHAPTER IV OF THE STATE SANITARY CODE 8:44-2.1 CHAPTER 44 CHAPTER IV OF THE STATE SANITARY CODE Authority NJ.S.A. 26: la-33 and 45:9-42.30; and Reorganization Plan No. 003-2005. Source and Effective Date
More informationClinical and Laboratory Standards Institute: Addressing POCT Needs; The Good, The Bad, and The Risky
Clinical and Laboratory Standards Institute: Addressing POCT Needs; The Good, The Bad, and The Risky Marcy Anderson MS, MT(ASCP) Director, Education 3 Rivers POCT Network June 7, 2012 Today s Presentation
More informationWhat is quality? Consistent delivery of a product or service according to expected standards.
What is quality? Consistent delivery of a product or service according to expected standards. Health care involves three main groups of people customers (patients), employees (service providers) and the
More informationStandards for the Medical Laboratory
Clinical Pathology 21-47 High Street Feltham Middlesex TW13 4UN Registered in England & Wales No. 2675095 Tel: (020) 8917 8400 Fax: (020) 8917 8500 e-mail: office@cpa-uk.co.uk www.cpa-uk.co.uk Clinical
More informationREPOSITIONING OUR CLINICAL LABORATORIES FOR EFFECTIVE AND EFFICIENT HEALTHCARE DELIVERY. By Prof. Ibironke Akinsete Chairman PathCare Nigeria
REPOSITIONING OUR CLINICAL LABORATORIES FOR EFFECTIVE AND EFFICIENT HEALTHCARE DELIVERY. By Prof. Ibironke Akinsete Chairman PathCare Nigeria Overview of Clinical Laboratories The duties of clinical laboratories
More informationLab Quality Confab Process Improvement Institute. New Orleans, LA. John Waugh 11/3/2015
Implementing a Single Quality Management System Across Multiple Hospitals of the Henry Ford Health System: Combining ISO 15189 with Lean to Deliver More Value Lab Quality Confab Process Improvement Institute
More information