Point of Care Quality Management. Procedure. Approving Authority: President and CEO, Keith Dewar
|
|
- Crystal Williamson
- 6 years ago
- Views:
Transcription
1 Subject/Title Point of Care Quality Management Procedure Approving Authority: President and CEO, Keith Dewar Manual: Reference Number: Effective Date: Dec 6 th, 2016 Revision Dates: Classification: Quality Health Services Contact for Interpretation: Laboratory Services - Point of Care Supervisor Source: Clinical Support Services See Policy See Form Procedure The purpose of this procedure is to describe the Regional Point of Care Testing Program. Point of Care Testing (POCT) refers to analytical patient testing activities performed outside the physical facilities of a clinical laboratory by personnel whose primary training is not in the clinical laboratory sciences. This bedside or near-patient testing must produce accurate and reproducible results comparable to that of a licensed laboratory. RQHR Laboratory Services uses a Quality Management System for its organizational structure. The Twelve Quality System Essentials (QSE) are the functional units. The QSE provides a systemic process-oriented approach so all aspects of quality are taken into account. The POCT Regional Testing Program is described using the 12 Quality System Essentials. 1.0 Organization 1.1 Medical Department Head of Laboratory Services is responsible for all aspects of the POCT Program 1.2 Laboratory Interdisciplinary POCT Committee will include the Medical Director, Director Operations, Medical Section Heads, Point of Care Supervisor and Manager Regulatory Affairs 1.3 Regional POCT Advisory Group includes representation from outside of Laboratory Services 1.4 Centrally coordinated system with daily operations under the POCT Supervisor 1.5 POCT supervisor may delegate some responsibilities for quality management to the various stakeholders (i.e. Nurse educators, unit supervisors) 1.6 Ensure all Standards and Regulations for POCT are met 1.7 POCT Quality Management System principles are followed Page 1 of 6 January 17, 2017
2 1.8 There are records that the test(s) is approved for use by the Medical Department Head of Laboratory Services, or Medical Section Head designate meeting CAP director qualifications, prior to use in patient testing. 2.0 Documents and Records 2.1 Document control system - Procedure review will follow RQHR Laboratory practices 2.2 Reporting of test results - Procedures will define reporting guidelines 2.3 Record retention guidelines 2.4 Procedure Manuals - Procedures will be written for all POCT systems 2.5 Discipline specific procedures will be written for testing as applicable (i.e. Nursing procedure for glucose testing) 3.0 Facilities and Safety 3.1 Standard precautions will be followed for specimen collection procedures 3.2 All RQHR safety guidelines apply, including the reporting of any safety incidents 3.3 POCT devices will be appropriately situated in designated areas 3.4 Disinfection and cleaning of instruments will follow manufacturer guidelines and be in compliance with regional policies 4.0 Personnel 4.1 Lists of testing personnel will be kept including which tests they are authorized to perform 4.2 Initial training will be provided by qualified personnel based on testing being performed (i.e. fetal fibronectin training is part of orientation to the Labor and Birth unit) 4.3 Training protocol will be stated in the individual test procedure 4.4 Competency assessment requirements will be stated in the test procedure using the CAP guidelines (waived vs. non-waived requirements) 4.5 Testing personnel will be traceable to reported control and patient results (i.e. unique identification number, operator initials in chart) 4.6 Ongoing competency assessment will be performed 4.7 Documentation of training and competency will be kept 4.8 All regional human resource policies will apply 5.0 Purchasing and Inventory 5.1 All reagents, controls and calibrators, supplies and equipment will be stored following manufacturer s instructions 5.2 Expiration dates will be noted as appropriate 5.3 Expired reagents, controls and calibrators will not be used for patient testing 5.4 New lot evaluations will be performed 5.5 Inventory and purchasing management will be handled by the RQHR Materials Management department 6.0 Equipment
3 6.1 All equipment used must be approved by the Medical Department Head of Laboratory Services or designee 6.2 All new systems must be evaluated before implementation using approved validation processes 6.3 General maintenance and function checks will be performed following manufacturer s instructions 6.4 Repair or replacement will be handled by individual contractual agreements 6.5 Temperature logs will be kept as appropriate 6.6 Room temperature supplies that are stored in a central supply area or on nursing units will be under the facility s temperature monitoring system 7.0 Process Control 7.1 Requests for new POCT implementation will follow a standardized process 7.2 Procedures will be in place for all POCT systems and will be available on the Intranet and/or in the unit 7.3 Collection procedure will be part of training and will be either included in procedure or be a separate procedure (i.e. fetal fibronectin specimen collection is part of nursing procedure) 7.4 Training will include pre analytical, analytical and post analytical considerations as well as technique of operation 7.5 Results will be legible and initialed by person performing the test 7.6 Quality Control requirements will be stated in each procedure 7.7 External liquid controls will be tested with each new lot or shipment of reagents, monthly or as stated in the manufacturer s requirements 7.8 Internal controls will be run on day of use 7.9 Individualized Quality Control Plans will be maintained for non-waived testing that meet eligibility for IQCP Control results must be validated before patient testing is done (i.e. Glucose meters can be locked if control testing has not been done in the last 24 hours) 7.11 Quality Control will be reviewed by the Medical Biochemist or alternate monthly 7.12 Linearity and precision testing will be performed with each new lot #, when indicated by quality control, after major maintenance and service, as recommended by manufacturer and at least every six months - as applicable 7.13 Troubleshooting, test limitations and instructions for handling of unusual results will be part of each procedure 7.14 Troubleshooting support is available from key user, POCT supervisor, and vendor technical support as applicable 7.15 Standard Laboratory Quality Assurance procedures must be followed to meet regulatory requirements 8.0 Information Management 8.1 Reference ranges, critical results and standard reporting procedures will be established 8.2 Testing personnel will be traceable to reported control and patient results
4 8.3 Results will be transcribed onto patient record following standard RQHR charting procedures with specification that it is a point of care test, and/or entered into specific programs for patient management 8.4 Establish electronic reporting mechanisms whenever possible that clearly distinguish point of care test results. 8.5 Roche Inform II meters and authorized testing personnel are managed through the Roche Cobas IT system 9.0 Occurrence Management 9.1 Non-conforming events when identified must be documented and reported following standard RQHR and Laboratory Services procedures 9.2 All occurrences will be assessed and followed up 9.3 Recall, Device Alert and other Product Information letters from vendors will be documented and recommended actions will be taken 10.0 Assessments 10.1 POCT is licensed under the Laboratory Licensing Program, Ministry of Health. Accreditation is administered by Laboratory Quality Assurance Program (LQAP), College of Physicians and Surgeons of Saskatchewan All General and Pasqua laboratories are College of American Pathologist (CAP) accredited College of American Pathologists (CAP) or other recognized program will be used for external proficiency testing 10.3 Proficiency testing will be done by a rotation of authorized users of the test and will follow the same guidelines as those used by the Laboratory Services 10.4 Proficiency testing and Quality control will be monitored by the POCT supervisor and Medical Biochemist 10.5 Assessments of Analytical Measurement Range, analyzer to analyzer, POCT device to main analyzer will be performed as required and will be stated in the individual procedure 10.6 Quality Indicators such as critical result audits and clerical audits will be performed 10.7 POCT Quality Management quarterly and annual reports will be prepared and presented at the Laboratory Services Continuous Quality Improvement committee meetings 11.0 Process Improvement 11.1 POCT will be part of the RQHR Laboratory Services Quality Management annual review 11.2 Process improvement will be initiated when data and assessments indicate a need for change Literature review of new methodologies and technologies will aid in keeping current with advances and changes in POCT 12.0 Service and Satisfaction
5 12.1 POCT is a rapidly evolving discipline with new technologies constantly becoming available. New processes and changing client needs will be assessed by the Laboratory Interdisciplinary POCT Committee in collaboration with the stakeholders 12.2 Develop a positive working relationship with all stakeholders in POCT (i.e. Nursing, Materials Management, vendors) 12.3 The POCT Device Request Form will facilitate and standardize POCT requests 12.4 Customer feedback will be encouraged to build a strong quality program References 1. Point of Care, General and All Common Checklists, College of American Pathologists 2. Laboratory Quality Assurance Program, College of Physicians and Surgeons of Saskatchewan 3. CLSI. Quality Management System: A Model for Laboratory Services; Approved Guideline Fourth Edition. CLSI document QMS01-A4. Wayne, PA: Clinical and Laboratory Standards Institute; CLSI. Essential Tools for Implementation and Management of a Point-of- Care Testing Program. 3rd ed. CLSI guideline POCT04. Wayne, PA: Clinical and Laboratory Standards Institute; CLSI. Glucose Monitoring in Settings Without Laboratory Support. 3rd ed. CLSI guideline POCT13. Wayne, PA: Clinical and Laboratory Standards Institute; CLSI. Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline Third Edition. CLSI document POCT12-A3. Wayne, PA: Clinical and Laboratory Standards Institute; The Medical Laboratory Licensing Act, The Medical Laboratory Licensing Regulations, College of American Pathologists, All Common Checklist, , COM Waived Test Implementation and Approval and COM Method Validation and Verification Approval Non-waived Tests Related Documents 1. LABPocOP1001 POCT Regional Policy 2. LABPocOP1001C1 POCT Organizational Chart 3. LABRegOP Proficiency Testing Program
6 Appendixes 1. LABPocOP1000F1 RQHR POCT Device Request Form Revision History Found in SoftTech Health Lab QMS Document Management System Author Tammy Ottenbreit, MLT, ART Geraldine Webb-Young, ART, MLT, C. Admin Revised by: Susan Askin, MLT Revised by: Virginia Marsh, MLT, DBA, CCE
CAP 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 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 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 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 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 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 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 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 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 informationVUMC Office of Research Research Core Facilities/Shared Resources 2015 Professional Development Track. Core Research Assistant I
Core Research Assistant I Minimum Qualifications: Bachelor s degree and 0 months experience Perform intake functions for the core laboratory. Receive and log sample or request for services Provide core
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 informationSubject: Quality Management for Origin date: 3/06 Point of Care and Waived Testing Reviewed: 2009 /2010 Revised: 2/2009
LOURDES HOSPITAL 169 Riverside Drive Binghamton, New York 13905 Subject: Quality Management for Origin date: 3/06 Point of Care and Waived Testing Reviewed: 2009 /2010 Revised: 2/2009 Introduction: This
More informationPoint of Care Testing
Office of Origin: Medical Center Clinical Laboratories I. PURPOSE II. III. To ensure that point-of-care (decentralized) laboratory testing is high quality and cost-effective, in order to contribute to
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 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 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 informationIQCP January Is Coming Fast What Do I Do?!? Jean Ball Bold, MBA, MT(HHS), MLT(ASCP
IQCP January Is Coming Fast What Do I Do?!? Jean Ball Bold, MBA, MT(HHS), MLT(ASCP December 3, 2015 Objectives Define what IQCP is Explain what the requirements are Learn the steps to formulate an IQCP
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 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 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 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 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 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 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 informationFulton County Medical Center. Position Description. Pathologist, Laboratory Manager, and Medical Technologist
Fulton County Medical Center Position Description Position Title: Reports To: Medical Laboratory Technician Pathologist, Laboratory Manager, and Medical Technologist Date: September 2004 I Position Summary:
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 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 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 informationHannah Poczter, AVP, Laboratories, Cari Gusman, Administrative Director, Ed Giugliano, PhD, Project Manager, Certified Six Sigma Black Belt
Using Ongoing Risk Assessments in All Labs to Yield Big Dividends: Why Northwell Health Now Provides Risk Assessments to Hospital Labs in Other Systems Hannah Poczter, AVP, Laboratories, Cari Gusman, Administrative
More informationSAMPLE. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
4th Edition C24 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions This guideline provides definitions, principles, and approaches to laboratory quality control
More informationBest Practices for Equipment Calibration and Analytical Controls in the Diagnostics Laboratory
Best Practices for Equipment Calibration and Analytical Controls in the Diagnostics Laboratory George Rodrigues, Artel (slides 2-16) Rebecca Butler, CareDx (slides 17-29) Agenda Agenda Theory / Regulations
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 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 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 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 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 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 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 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 08.21.2017 2 of 33 Disclaimer and Copyright Notice
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 informationINSERT ORGANIZATION NAME
INSERT ORGANIZATION NAME Quality Management Program Description Insert Year SAMPLE-QMProgramDescriptionTemplate Page 1 of 13 Table of Contents I. Overview... Purpose Values Guiding Principles II. III.
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 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 informationQC Explained Quality Control for Point of Care Testing
QC Explained 1.0 - Quality Control for Point of Care Testing Kee, Sarah., Adams, Lynsey., Whyte, Carla J., McVicker, Louise. Background Point of care testing (POCT) refers to testing that is performed
More informationCollege of Physicians and Surgeons of Saskatchewan Laboratory Quality Assurance Program. Policy Manual Edition
College of Physicians and Surgeons of Saskatchewan Laboratory Quality Assurance Program Policy Manual 2014 Edition LABORATORY QUALITY ASSURANCE POLICY MANUAL SUMMARY OF POLICY MANUAL CHANGES The following
More informationPlan for Quality to Improve Patient Safety at the POC
Plan for Quality to Improve Patient Safety at the POC SHARON S. EHRMEYER, PH.D., MT(ASCP) PROFESSOR, DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE DIRECTOR OF MEDICAL TECHNOLOGY PROGRAM UNIVERSITY OF
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 informationPOSITION DESCRIPTION
State of Michigan Civil Service Commission Capitol Commons Center, P.O. Box 30002 Lansing, MI 48909 Position Code 1. LABSCIA POSITIO DESCRIPTIO This position description serves as the official classification
More informationRapid Specimen Testing In the Medical Office (POCT)
Rapid Specimen Testing In the Medical Office (POCT) Over the past few years, the new health care system and managed care have affected patients by restricting many of their health decisions and physicians
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 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 informationCollege of American Pathologists 325 Waukegan Road, Northfield, Illinois Advancing Excellence
Attachment A College of American Pathologists 325 Waukegan Road, Northfield, Illinois 60093-2750 800-323-4040 http://www.cap.org Advancing Excellence August 31, 20XX Reference Number: 2365 CAP Number:
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 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 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 informationMaster. Point-of-Care-Testing Checklist. Every patient deserves the GOLD STANDARD... CAP Accreditation Program
Master Every patient deserves the GOLD STANDARD... Point-of-Care-Testing Checklist CAP Accreditation Program College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 07.28.2015
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 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 informationQUALITY POLICY MANUAL. Revision: 05 Author: T. Joseph Issue Date: 6/6/2010 Approved By: Dr S. King
This document together with the procedures specified in this manual, represent the quality management system of Laboratory Services & Consultations Ltd. It has been complied to meet the requirement of
More informationPoint of Care Testing. BOPCC May 31, 2011 Beatrice O Keefe, Chief Laboratory Field Services California Department of Public Health
Point of Care Testing BOPCC May 31, 2011 Beatrice O Keefe, Chief Laboratory Field Services California Department of Public Health Objectives Describe Direct patient Care in California law Describe Point
More informationSAMPLE. Essential Tools for Implementation and Management of a Point-of-Care Testing Program
3rd Edition POCT04 Essential Tools for Implementation and Management of a Point-of-Care Testing Program This guideline provides direction to users of in vitro diagnostic devices outside the medical laboratory
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 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 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 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 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 informationDisclosures. Relevant Financial Relationship(s): Nothing to Disclose. Off Label Usage: Nothing to Disclose 6/1/2017. Quality Indicators
Laurie Griesmann, Quality Specialist May 17, 2017 Disclosures Relevant Financial Relationship(s): Nothing to Disclose Off Label Usage: Nothing to Disclose 1 Objectives Define a quality indicator. Recognize
More informationAdministrative Policies and Procedures
Administrative Policies and Procedures Originating Venue: Environment of Care Policy No.: EC 2007 Title: Environment of Care Management Program Cross Reference: EC 2001 Date Issued: 04/14 Authority Environmental
More information5. returning the medication container to proper secured storage; and
111-8-63-.20 Medications. (1) Self-Administration of Medications. Residents who have the cognitive and functional capacities to engage in the self-administration of medications safely and independently
More informationKaren W. Dyer MT(ASCP), DLM Director, Division of Laboratory Services Centers for Medicare & Medicaid Services CLIA
Karen W. Dyer MT(ASCP), DLM Director, Division of Laboratory Services Centers for Medicare & Medicaid Services Objectives Basics Certificate of Waiver (CoW) laboratories Triagency responsibilities FDA
More information5/8/2015. Individualized Quality Control Plans (IQCP) Changes to the CMS Quality Requirements. CLIA Quality Control Evolution of the Process
Individualized Quality Control Plans (IQCP) Changes to the CMS Quality Requirements John Shalkham, MA, SCT(ASCP) Office of Quality Assurance Wisconsin State Laboratory of Hygiene Clinical Assistant Professor,
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 informationinsights INTO Quality Control MAY/JUNE 2013 COLA S
MAY/JUNE 2013 COLA S insights INTO Quality Control ALSO IN THIS ISSUE: Letter from the Chair.............................. 2 Evolution of QC....................................... 3 What is IQCP?..................................................
More informationSAMPLE. Use of Delta Checks in the Medical Laboratory
1st Edition EP33 Use of Delta Checks in the Medical Laboratory This guideline provides approaches for selecting measurands for which delta checks are useful, establishing delta check limits and rules for
More informationFast Focus on Compliance
12 Inspector Tools To Make Your Inspection Go More Smoothly 325 Waukegan Rd. Northfield, IL 60093 t: 800-323-4040 cap.org Version no. 12 Inspector Tools to Make Your Inspection Go More Smoothly Purpose
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 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 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 informationPRACTICAL APPLICATION OF ISO BY ACCREDITATION BODIES - A comparison with ISO/IEC Page 128. ejifcc2004vol15no4pp
PRACTICAL APPLICATION OF ISO 15189 BY ACCREDITATION BODIES - A comparison with ISO/IEC 17025 Bella Ho, Hong Kong Accreditation Service Introduction ISO 15189:2003 is an international standard developed
More informationPrescriptive Authority & Protocol Agreement
Physician Information Name: License Number: Address of Primary Practice Address of Other Practice Address of Other Practice Prescriptive Authority & Protocol Agreement Advanced Practice Registered Nurse
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 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 informationPOINT OF CARE TESTING MED Laboratory Branch Kim DeGroat, RMLS - Frankfurt Region Wilfred Lovelock, RMLS - Dakar Region
POINT OF CARE TESTING MED Laboratory Branch Kim DeGroat, RMLS - Frankfurt Region Wilfred Lovelock, RMLS - Dakar Region 1 Learning Objectives Define Point of Care Testing Discuss advantages & disadvantages
More informationPresentation Outline
Management Responsibility in Good Laboratory Practice Praveen Sharma IFCC Committee on Clinical Laboratory Management http://www.ifcc.org/ifcc-education-division/emd-committees/c-clm/ Symposium on Improvement
More informationJoint Commission Laboratory Accreditation: Why It Is Right For Your Organization
Joint Commission Laboratory Accreditation: Why It Is Right For Your Organization Jennifer Rhamy MBA, MA, MT(ASCP)SBB, HP Executive Director, Laboratory Accreditation Program 1 Objectives 1. Define the
More informationTHE CALIFORNIA STATE UNIVERSITY Office of the Chancellor 400 Golden Shore Long Beach, CA (562)
THE CALIFORNIA STATE UNIVERSITY Office of the Chancellor 400 Golden Shore Long Beach, CA 90802-4210 (562) 951-4411 Date: June 20, 2006 Code: HR 2006-15 To: From: CSU Presidents Jackie R. McClain Vice Chancellor
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 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 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 informationHow to Improve the Laboratory Experience CLS and MLT Working Together
How to Improve the Laboratory Experience CLS and MLT Working Together Dora W. Goto, MS, CLS, MLS(ASCP) CM California Association for Medical Laboratory Technology Immediate Past President Fremont, CA September
More informationDEPARTMENT OF CLINICAL LABORATORY SCIENCES SCHOOL OF HEALTH TECHNOLOGY AND MANAGEMENT THE UNIVERSITY AT STONY BROOK STONY BROOK, NEW YORK
DEPARTMENT OF CLINICAL LABORATORY SCIENCES SCHOOL OF HEALTH TECHNOLOGY AND MANAGEMENT THE UNIVERSITY AT STONY BROOK STONY BROOK, NEW YORK 11794-8205 CHEMISTRY COMPETENCY EVALUATION FORM STUDENT NAME: CLINICAL
More informationQMP-LS: A Canadian Regional EQA Program How Labs Get In and Out of Trouble in Ontario
QMP-LS: A Canadian Regional EQA Program How Labs Get In and Out of Trouble in Ontario Anne Raby Mayo/NASCOLA Coagulation Testing Quality Conference April 14 th, 2009 2 Disclosure Relevant Financial Relationship(s)
More informationLearner s Guide. Public Health Laboratory Core Competency Seminar E-modules
Learner s Guide Public Health Laboratory Core Competency Seminar E-modules Acknowledgements and Disclaimers These e-learning courses and Learner s Guide were made possible through support provided by the
More informationThe Manitoba Quality Assurance Program (MANQAP) ANNUAL REPORT April 1, 2008 to March 31, 2009 Manitoba Quality Assurance Program (MANQAP)
The Manitoba Quality Assurance Program (MANQAP) ANNUAL REPORT April 1, 2008 to March 31, 2009 Manitoba Quality Assurance Program (MANQAP) I. INTRODUCTION The objective of the Manitoba Quality Assurance
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 informationSTANDARD / ELEMENT EXPLANATION SCORING PROCEDURE SCORE
31.00.00 Condition of Participation: Outpatient Services If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with 482.54 The Medicare Hospital Conditions
More informationCITY OF REEDLEY WWTP OPERATOR-IN-TRAINING/LAB TECHNICIAN TRAINEE WWTP OPERATOR/LAB TECHNICIAN WWTP OPERA TOR II/SENIOR LAB TECHNICIAN
ORIGINAL CITY OF REEDLEY WWTP OPERATOR-IN-TRAINING/LAB TECHNICIAN TRAINEE WWTP OPERATOR/LAB TECHNICIAN WWTP OPERA TOR II/SENIOR LAB TECHNICIAN DEFINITION Under immediate superv1s1on 0/VWTP Operator-In-Training/Lab
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 informationArizona Department of Health Services Licensing and CMS Deficient Practices
Arizona Department of Health Services Licensing and CMS Deficient Practices Connie Belden, RN., Bureau of Medical Facility Licensing August 8, 2013 General Comments Deficient Practices per visit Trend
More information