3/14/2016. The Joint Commission and IQCP. Objectives. Before Getting Started
|
|
- Antony Whitehead
- 6 years ago
- Views:
Transcription
1 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 point for you own IQCP programs Use The Joint Commission standards to develop your IQCP programs Before Getting Started Check with your state for eligibility and restrictions State IQCP Acceptance Chart on Joint Commission Connect TM Check with your accreditor: The Joint Commission QSA EPs 1 8 Appendix C: IQCP: Eligible Requirements All specialties/subspecialties except tests that are only listed within pathology Update your e-app with your IQCP information 1
2 Ask Yourself Is the test moderate or high complexity? Does the test fall within an eligible specialty/subspecialty? Take into account those tests with multiple specialties. Does the manufacturer allow a QC frequency that is less than CLIA requirements AND you want to base your QC program on your individualized risk? Does the manufacturer allow a QC frequency that is less than Joint Commission standards requirements AND you want to base your QC program on your individualized risk? Not eligible for IQCP Waived Testing Testing within the specialty/subspecialty of pathology except those tests with a multiple specialty outside of pathology Will perform QC at a frequency that MEETS or EXCEEDS CLIA requirements Will perform QC at a frequency that MEETS or EXCEEDS Joint Commission standards requirements Start Here Instruments that used EQC i-stat, Alere Meter, TLI IQ System Moderate complexity kit tests Microbiology Media QC Streamlined QC for organism identification Weekly QC for antimicrobial susceptibility Blood Gases ACTs Where manufacturer QC protocol is less stringent than CLIA or Joint Commission requirements 2
3 What CAN be Delegated Establishing IQCP as part of the laboratory s overall QC program to the Technical Consultants or Technical Supervisors Specific portions of IQCP tasks to other qualified laboratory employees Delegation must be in writing! CLIA Laboratory Director Responsibilities Accurate and reliable test results that are appropriate for patient care no matter what QC method they use who is delegated QC responsibilities Signing and dating the QCPs before implementation and after changes QSA The laboratory develops an individualized quality control plan (IQCP) in an eligible specialty or subspecialty. 3
4 Eligible Specialties or Subspecialty All CLIA specialties/subspecialties will be included in IQCP, except... Pathology Histopathology Oral Pathology Cytology IQCP is an option for Laboratory Developed Tests (LDTS) See Appendix C in our CAMLAB for a list of standards that are eligible for IQCP Tests with Multiple Specialties If such a test is eligible for IQCP based on one of its specialties/subspecialties, then the lab may elect to use IQCP for that test regardless of the specialty/subspecialty listed on their CLIA certificate. Example: FISH testing may be classified as either histopathology or cytogenetics. The lab has histopathology on their CLIA certificate but not cytogenetics. Because this test may also be considered as cytogenetics, IQCP would be allowed even though it is listed as Histopathology on their CLIA certificate. Percentage IQCP by Specialties/Subspecialties Chemistry Microbiology Immunology Point-of-Care Hematology Other Immunohematology As of 02/26/16 4
5 Percentage of the number of Test Systems Implemented 5 or more As of 02/26/16 Percentage Expected to Expand Usage of IQCP Yes I'm not sure No As of 02/26/16 QSA IQCP EP 1 A complete IQCP that consists of the following three parts: Risk assessment, Quality control plan, Quality assessment 5
6 The Three Components of IQCP Risk Assessment (RA) Identify & evaluate potential failures and sources of errors in a testing process Quality Control Plan (QCP) Policies/procedures to prevent or reduce the risk and control test quality Quality Assurance (QA) Continuous quality monitoring to evaluate the effectiveness of the IQCP QSA Risk Assessment (RA) EP 2 A risk assessment that is established by the laboratory in its own environment by its own testing personnel. Note: The risk assessment may include test, method or instrument verification data; performance specifications; or historical quality control data. Published or manufacturer data may also be included, but cannot be the only data source for the risk assessment. EP 3 A risk assessment that contains the following five components: Specimen, Environment, Reagent, Test system, Testing personnel QSA Risk Assessment (RA) EP 4 A risk assessment that encompasses the following three phases of the entire testing process: Preanalytic, Analytic, Postanalytic Note: The risk assessment identifies the sources of potential failures and errors for a testing process, and evaluates the frequency and impact of those failures and sources of errors. EP 5 Laboratories that develop an individualized quality control plan (IQCP) include the following: a risk assessment that includes the manufacturer s instructions or other information needed to assess risk in all three phases of the testing process. Note: The risk assessment includes function and maintenance checks as required by, and not less than, manufacturers instructions. 6
7 Performing the Risk Assessment (RA) To conduct a Risk Assessment the lab must: Use their own staff (no manufacturer reps) Use their own data (historical or new) Use more than only published or manufacturer data Include all five components Identified the sources of potential failures and errors Evaluates the frequency and impact of those failures and errors Use the manufacturer s instructions or other information needed to assess all three phases of testing Includes function and maintenance checks as required by the manufacturer IQCP Risk Assessment (RA) Five Components: Specimen Environment Reagent Test system Testing personnel Three phases of the testing process: Pre analytic Analytic Post analytic RA: Specimen Patient preparation Specimen collection Specimen labeling Specimen storage, preservation, and stability Specimen transportation Specimen processing Specimen acceptability and rejection Specimen referral 7
8 RA: Environment Temperature Airflow/ventilation Lighting/intensity Noise and vibration Humidity Adequate Space Altitude Dust Water Static discharges Utilities (electrical failures, current variations, surges RA: Reagent Shipping/receiving conditions Storage conditions Expiration Date (may differ based on storage requirements) Preparation instructions/require ments RA: Test Systems Inadequate sampling Clot detection capabilities Capabilities for detection of interfering substances (e.g., hemolysis, lipemia, icterus, turbidity) Calibration associated issues Failure of system controls and function checks Built-in procedural and electronic controls (internal controls) External or internal liquid quality control (assayed vs. unassayed) Temperature monitors and controllers 8
9 RA: Test Systems Mechanical/electronic failure of test system optics Pipettes Barcode readers Software/hardware Data transmission RA: Testing Personnel Appropriate education and experience qualifications License requirements Orientation and Training Competency failure to follow instructions incorrect test interpretation Adequate staffing Vacancy rates and Turnover rates Tools for Conducting a RA Table or grids Fishbone diagrams Process flow diagrams Bullets or simple listing Paragraph format Highlighting/Underlining in the Manufacturer s Instructions 9
10 Example of RA Documentation Pre Analytic Analytic Post Analytic Specimen Environment Reagent Test Systems Testing Personnel Example of RA Documentation Example of RA Documentation 10
11 Example of RA Documentation QSA Quality Control Plan EP 6 Laboratories that develop an individualized quality control plan (IQCP) include the following: A quality control plan for devices at each location throughout a facility. EP 7 Laboratories that develop an individualized quality control plan (IQCP) include the following: A quality control plan (or changes in the plan) that the laboratory director signs and dates before implementation.. Quality Control Plan (QCP) A laboratory s standard operating procedure that describes the practice, resources, and procedures to control the quality of a particular test. 11
12 Quality Control Plan (QCP) Is required for each device location if you have different risks you want to mitigate If all risks are the same, 1 QCP can list all device locations Must provide for the immediate detection of errors Must monitor overtime the accuracy and precision of the test performance Must not be less stringent than the manufacturer s guidelines Quality Control Plan (QCP) Must be signed and dated by the Lab Director listed on the CLIA certificate before implementation and when changes are made Must use your own data to support the chosen QC rationale Must include: Number Type Frequency of testing Acceptability criteria of the quality control used Examples of Quality Controls External controls Electronic controls Internal controls Procedural controls Verification Data or establishment of performance specification Data Maintenance records Calibrations Temperature records Proficiency Testing results Training and competency assessments Corrective Actions taken 12
13 QSA Quality Assessment EP 8 Laboratories that develop an individualized quality control plan (IQCP) include the following: A quality assessment that includes documentation of corrective action and preventive action to monitor ongoing effectiveness. Quality Assessment (QA) An ongoing review process that encompasses all facets of the laboratory s technical and nontechnical functions and all locations/sites where testing is performed. Quality Assessment (QA) Closes the loop to your RA and QCP Activities you are already doing Should have a QA activity for each QC activity 1 QA may be sufficient for all testing locations QA is used to determine if the quality activities you have put in place are working 13
14 Quality Assessment helps you Make sure that your QCP is working as expected Monitor errors and QC failures Identify errors and failures so you can take the appropriate corrective action Investigate the cause of the error and reassess your risk assessment if needed Evaluate whether any changes need to be made in the QCP Quality Control QC vs. QA Recording the refrigerator temperature Documenting control results Documenting personnel training Documenting maintenance Documenting personnel competency Quality Assessment Reviewing the temperature records Reviewing the control results Reviewing the personnel training records Reviewing maintenance records Reviewing personnel competency records Examples of Documents to Review QC results PT performance review (scores, failures, and trends) Temperature logs Specimen rejection/qns log TAT reports Complaint reports Specimen recollection logs Communication logs Review of preventive measures, corrective actions, and follow-up Maintenance log Patient results review Training and competency documents FDA alerts Delta check logs Panic value/critical results log 14
15 Corrective Actions for Testing Process Failures Must conduct an investigation that identifies the cause and impact The investigation must include: Documentation of all corrections Corresponding corrective actions for all affected patient results Evaluation of the effectiveness of the corrective action Must implement corrections and corresponding corrective actions If necessary, must update the RA and modify the QCP Reevaluating your QCP as part of your QA Not required by our standard When changes occur in the specimen, test system, reagent, environment, and testing personnel When the Quality Assessment identifies a problem Consider within the first 6 months of a new or updated QCP Consider an annual review EP 1 Three Parts to IQCP EP 7 LD signature Percentage of IQCP Noncompliance EP 4 Three Testing Phases EP 6 QCP by locations EP 2 Lab specific data EP 8 QA EP 3 Five Components As of 02/26/
16 Watch Out! Still using EQC for blood gases performed outside the lab Forgetting about moderate complexity kit tests Not realizing you need IQCP for microbiology for: Media QC Streamlined QC for organism identification Weekly QC for antimicrobial susceptibility IQCP not implemented (completed but not signed by lab director) and performing QC at a frequency less than CLIA requirements IQCP did not take into consideration all testing locations Not understanding that the Risk Assessment is used to determine the type and frequency of quality control used Being part of a system and using the primary lab s Risk Assessment as their own Not setting aside time to work on IQCP Additional Findings Related to IQCP Standard LD EP 1 The laboratory director, technical consultant, and/or technical supervisor define the laboratory s criteria for the following: Quality control, Proficiency testing, Reporting of results QSA EP 3 The laboratory uses two quality control materials of different concentrations for each quantitative procedure on each day the procedure is performed. The quality control results are documented. QSA EP 4 The laboratory uses negative and positive control material for each qualitative procedure on each day the procedure is performed. The quality control results are documented Noncompliance Rate 2016 Noncompliance Rate as of 02/26/ % 21.49% 1.04% 5.08% 0.65% 7.56% Additional Findings Related to IQCP Standard QSA EP 2 The laboratory uses a positive and, as appropriate, a negative control material for each qualitative procedure in bacteriology, mycobacteriology, and mycology, at a frequency consistent with laboratory policy or the manufacturer s instructions, if more stringent. The quality control results are documented. QSA EP 2The laboratory performs antibacterial and antifungal susceptibility quality control testing each day the procedure is performed unless the laboratory demonstrates satisfactory performance that would qualify the laboratory to perform quality control testing on a weekly basis. The quality control results are documented Noncompliance Rate 2016 Noncompliance Rate as of 02/26/ % 10.84% 0.32% 12.5% 16
17 Additional Findings Related to IQCP Standard QSA EP 3 Either the laboratory or the preparer performs quality control testing on new batches of microbiological culture media, including sterility testing, using recommended organisms before or concurrently with the use of new batches of media. The quality control results are documented. QSA EP 1 The laboratory tests at least three levels of quality control materials (acid, normal, alkalosis) for blood gas testing each day the procedure is performed. The quality control results are documented Noncompliance Rate 2016 Noncompliance Rate as of 02/26/ % 15.66% 1.19% 16.38% Additional Findings Related to IQCP Standard QSA EP 2 The laboratory tests at least one level of quality control material for each eight hours of patient blood gas testing. The quality control results are documented. Note: The laboratory should attempt to perform quality control testing as close to 8-hour intervals as possible. A range may be specified in written policy, such as within 15 minutes before or after the 8- hour mark, providing a 30-minute window. Ranges in excess of +/- 30 minutes that produce a window of more than an hour do not meet the intent of this element of performance Noncompliance Rate 2016 Noncompliance Rate as of 02/26/ % 18.10% i-stat IQCP Example This is only an example and may not include all risks a laboratory may identify. AACC
18 RA - Specimen RA Test System RA - Reagent 18
19 RA - Environment RA Testing Personnel NICU Based upon the specific location risks the Laboratory Director determined that the NICU staff must run two levels of external quality control once every day of testing AND one level of external quality control with every patient sample. Since this QC frequency exceeds the CLIA requirements: IQCP is not applicable QCP is not required 19
20 Quality Assurance Resources Joint Commission Connect TM Perspectives Articles (March 2014, July 2015) IQCP PowerPoint & Risk Assessment Template Leading Practice Library: IQCP examples Lab Focus publications (Aug/Sept 2015; February 2016) Submit a question to Standards Interpretation CMS Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.ht ml ASM website for microbiology examples 20
21 21
22 Questions 22
CLIA 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 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 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 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 informationCLIA & Individualized Quality Control Plan (IQCP) Karen W. Dyer MT(ASCP), DLM Director (Acting) Division of Laboratory Services
& Individualized Quality Control Plan (IQCP) Karen W. Dyer MT(ASCP), DLM Director (Acting) Division of Laboratory Services Centers for Medicare & Medicaid Services Disclosure I am not receiving an honorarium
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 informationCLIA & Individualized Quality Control Plan (IQCP) Judith Yost Director Division of Laboratory Services
& Individualized Quality Control Plan (IQCP) Judith Yost Director Division of Laboratory Services 1 Objectives Provide Background & History of Quality Control Describe the Development of IQCP Present an
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 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 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 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 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 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 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 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 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 informationPro-QCP SAMPLE REPORT
Pro-QCP SAMPLE REPORT 2016 CarePoint Solutions, Inc. All rights reserved. General Hospital 123 N Main St New York, NY 12345 What is an IQCP? The Individualized Quality Control Plan (IQCP) is the Clinical
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 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 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 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 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 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 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 SCHOOL OF MEDICINE AND PUBLIC HEALTH MADISON, WI = Quality
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 informationPreanalytical Errors in Laboratory - Their Consequences and Measures to Reduce Them
Preanalytical Errors in Laboratory - Their Consequences and Measures to Reduce Them Tazeen Farooqui, Student of MBA (HM), College of Hospital Administration, TMU, Moradabad Email:-tazeenfarooqui01@gmail.com
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 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 informationReducing Risk in the Laboratory: IQCP In Action! 9/24/2015
2015 APHL ASCLS Webinar Series Reducing Risk in the Laboratory: IQCP In Action! 9/24/2015 Speaker James H. Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology, and Immunology, Medical Director,
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 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 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 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 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 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 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 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 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 informationTHE VALUE OF CAP S Q-PROBES & Q-TRACKS
THE VALUE OF CAP S Q-PROBES & Q-TRACKS Peter J. Howanitz MD Professor, Vice Chair, Laboratory Director Dept. Of Pathology SUNY Downstate Brooklyn, NY 11203, USA Peter.Howanitz@downstate.edu OVERVIEW Discuss
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 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 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 informationSUTTER MEDICAL CENTER, SACRAMENTO DEPARTMENT OF LABORATORY MEDICINE. Rules and Regulations
SUTTER MEDICAL CENTER, SACRAMENTO DEPARTMENT OF LABORATORY MEDICINE Rules and Regulations I Goals and Objectives The goals and objectives of the members of the Department shall be to provide the best possible
More informationRegulatory,Quality & Emergency Preparedness. MaryBeth Parache Director, Quality Affairs New York Blood Center
Regulatory,Quality & Emergency Preparedness MaryBeth Parache Director, Quality Affairs New York Blood Center 1 Regulatory 2 Who regulates us? Food and Drug Administration (FDA) Blood, tissue, HCT/P, medical
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 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 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 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 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 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 informationinsights INTO Preparing Your Laboratory For Its Next Survey COLA S FALL 2016 ALSO IN THIS ISSUE: Letter from the Chair... 2
COLA S FALL 2016 insights INTO Preparing Your Laboratory For Its Next Survey ALSO IN THIS ISSUE: Letter from the Chair... 2 Preparing For Your Next Laboratory Survey... 3 Survey Preparation Through Review
More informationClinical Laboratories West Virginia University Hospitals. Resident Orientation
Clinical Laboratories West Virginia University Hospitals Resident Orientation Peter L. Perrotta, MD Medical Director Clinical Laboratories pperrotta@hsc.wvu.edu Joseph A. DelTondo, DO Director of Autopsy
More informationAPPLICATION CHECKLIST
NEW YORK STATE DEPARTMENT OF HEALTH CERTIFICATE OF QUALIFICATION APPLICATION CHECKLIST All Applicants: Provide a copy of your current curriculum vitae. Include a $40 application fee, payable to New York
More informationMartin Health System Stuart, Florida Laboratory Services. Laboratory Services and Policies
Martin Health System Stuart, Florida Laboratory Services Laboratory Services and Policies Service Commitment: It is the goal of the Martin Health System s Clinical Laboratory to provide the medical community
More information: Suzanna Immanuel Place, date of birth : Jakarta, 11 th March 1953 Education : MD FMUI 1978 Profession : Clinical Pathologist (SpPK) FMUI 1984
Name : Suzanna Immanuel Place, date of birth : Jakarta, 11 th March 1953 Education : MD FMUI 1978 Profession : Clinical Pathologist (SpPK) FMUI 1984 Consultant [SpPK(K)] ISCP (PDSPatKlin) 1996 Office :
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 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 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 informationSUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE
SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE No: LAB-1 Subject: PROCEDURES FOR HANDLING Page 1 of 6 INPATIENT AND OUTPATIENT LABORATORY Prepared by: Dynesdal Wint
More informationLaboratory Accreditation Manual Edition Editor: Francis E. Sharkey, MD, FCAP
Laboratory Accreditation Manual 2012 Edition Editor: Francis E. Sharkey, MD, FCAP TABLE OF CONTENTS Topic Inspector Page Information Laboratory Information Introduction..... 8 Overview of Accreditation
More informationinsights COLA Updates Into MAY / JUNE 12 COLA s
COLA s MAY / JUNE 12 insights Into COLA Updates ALSO IN THIS ISSUE: Letter from the Chair... 2 Criteria Updates... 3 Current Credentialing Practices... 8 Competency Assessment... 10 Competency Assessment
More informationSpecimen Collection Regulations and Standards
Specimen Collection Regulations and Standards Stacy Olea, FACHE, MBA, MT(ASCP) Field Director Accreditation and Certification Operations The Joint Commission Scope Specimen collection could be occurring:
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 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 informationAllen D. Leman Swine Conference
Allen D. Leman Swine Conference Volume 39 2012 Published by: Veterinary Continuing Education Sponsors We thank the following sponsors: Platinum Bayer Animal Health Pfizer Animal Health Gold Novartis Animal
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 informationPrimary Ingredients. Primary Ingredients. Referrals. Positive cash-flow. Dedication & growth Give it some time and put effort into it
Establishing Community-Based Public Health and Screening Services Jeff Rochon, Pharm.D. Director of Pharmacy Care Services Washington State Pharmacy Association Primary Ingredients Establish the Interest
More informationCHALLENGES IN POCT. Dr. Jayesh P. Warade. Consultant Biochemistry and Quality Manager, Meenakshi Mission Hospital and Research Centre, Madurai, India
CHALLENGES IN POCT Dr. Jayesh P. Warade Consultant Biochemistry and Quality Manager, Meenakshi Mission Hospital and Research Centre, Madurai, India Abstract: Point of care testing (POCT) refers to testing
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 informationMLT 215 CLINICAL PRACTICE COURSE OUTLINE. Pre requisites: MLT 112, 200, 207, 212 & 214
MLT 215 CLINICAL PRACTICE COURSE OUTLINE Hours: Clinical lab practice 14 weeks/560 hours Pre requisites: MLT 112, 200, 207, 212 & 214 Credits: 10 Catalog description: Clinical practice takes place in an
More informationCME/SAM. Determination of Turnaround Time in the Clinical Laboratory
Clinical Chemistry / Turnaround Time in a Clinical Laboratory Determination of Turnaround Time in the Clinical Laboratory Accessioning-to-Result Time Does Not Always Accurately Reflect Laboratory Performance
More informationClinical Laboratory Science Courses
Clinical Laboratory Science Courses 1 Clinical Laboratory Science Courses Courses CLSC 2111. Molecular Diagnostics Lab. This laboratory provides the basic skills necessary for performing and applying molecular
More information4. Program Regulations
Table of Contents LAB-35 iv 04/01/10 401.401: Introduction... 4-1 401.402: Definitions... 4-1 401.403: Eligible Members... 4-2 401.404: Provider Eligibility... 4-2 401.405: Laboratory Services Provided
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 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 informationUsing the epoc Point of Care Blood Analysis System Reduces Costs, Improves Operational Efficiencies, and Enhances Patient Care
Using the epoc Point of Care Blood Analysis System Reduces Costs, Improves Operational Efficiencies, and Enhances Patient Care Clarke Woods, BS, RRT, FABC, Director, Cardiopulmonary Services, Pinnacle
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 informationScope of Service. Department Mission
Scope of Service Department Mission Scope of Services Provided The Department of Laboratory Services provides a wide array of testing and other services to Memorial Health System s patients, and to other
More informationGUIDELINE FOR HANDLING FOMEMA SPECIMEN
GLENMARIE BRANCH GUIDELINE FOR HANDLING QUALITY PROCEDURE QP2-OP02-02 MASTER COPY Prepared by Approved by Signature :... Signature :... Name : Ong Keh Seen Name : DR. Lily Manorammah A/P V.J.Samuel Designation
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 informationPOINT OF CARE TESTING POLICY Page 1 of 6 Reviewed: October 2017
Page 1 of 6 Policy Applies to: All clinical staff involved in using Point of Care Testing (POCT) equipment. Related Standards: Health & Disability Standard 4.2.3 Amenities, fixtures, equipment and furniture
More informationCarter Healthcare, Inc
PURPOSE WAIVED TESTING Policy No. 2-047 To define the organization's compliance with waived testing criteria and the need for a certificate of laboratory services. POLICY The Clinical Laboratory Improvement
More informationSurviving Katrina: How Touro Infirmary Met the Challenges of the Disaster! Paula McCreary MT(ASCP) Technical Manager Pathology Department
Surviving Katrina: How Touro Infirmary Met the Challenges of the Disaster! Paula McCreary MT(ASCP) Technical Manager Pathology Department Touro Infirmary New Orleans, LA 159 year old non-profit private
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 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 information