U.S. and Worldwide Quality Management System Models for Quality POCT Results SHARON S. EHRMEYER, PH.D., MT(ASCP), PROFESSOR, DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH, MADISON WI, USA
= Quality Meeting the requirements or needs of the testing site s customers -- doctors and patients and satisfying their expectations 2
Characteristics of Quality POCT Results Useful Accurate Precise Reliable Timely 3
Under the best of circumstances Things happen! 4
We need Quality Results and Quality Practices! 5
Criteria for Quality POCT in 2012: Correct test ordered Correct patient Correct time for collection Correct specimen and processing Correct (accurate) test result Correct patient record Correct clinical interpretation (leading to the) Correct and timely clinical response Wrongs instead of Corrects jeopardize quality and patients safety
Quality in POCT Requires: Planning Planning Planning 7
Quality Management System Addresses all aspects that can impact testing to assure quality 8
* ISO 9000:2005 -- Quality management systems -- Fundamentals and vocabulary Quality Management System Coordinated activities to direct and control an organization with regard to quality* Provides the basic structure for testing with a focus on quality Describes, documents, implements, measures, and monitors the effectiveness throughout the path of workflow
Path of Workflow Preanalytical Analytical Postanalytical Quality Management System: A Model for Laboratory Services (GP26), CLSI, Wayne, PA
Clinician Patient Testing -- Link CLINICIAN CLINICIAN PATIENT PATIENT REQUEST clinical request input Testing process Pre-analytical Analytical Post-analytical REPORT clinical information output Mario Plebani, MD, Depart Lab Medicine, University Hospital, Padova,Italy
QMS Building blocks -- Quality System Elements (QSE) Interrelated elements Direct and control how quality policies are implemented and quality objectives are achieved Ensure that processes fulfill quality objectives Meet customer, organizational and regulatory/accreditation requirements www.praxiom.com/iso-definition.htm; CLSI Quality Management System: A Model for Laboratory Services (GP-26-A4) 2011 www.clsi.org; ISO 9001
Quality Essential Elements in QMS 1. Documents and records 2. Organization 3. Personnel 4. Equipment 5. Purchasing and inventory 6. Process control 7. Information management 8. Occurrence management 9. Internal and external assessment 10. Process improvement 11. Customer service/ satisfaction 12. Facilities and safety
QSE and Path of Workflow Preanalytical Analytical Postanalytical QSE apply to all operations in the path of workflow Quality Management System: A Model for Laboratory Services (GP26), CLSI, Wayne, PA
Quality Management System Quality Management System: A Model for Laboratory Services (GP26), CLSI, Wayne, PA
ISO s and CLIA s Quality Management System Models The Devil is in the Details
ISO15189 (2007) and ISO 22870 (2006) Medical Laboratories Particular requirements for quality and competence POCT Requirements for quality and competence
ISO 15189/22870 Incorporates Quality System Essentials into: Management and Technical Requirements
ISO 15189/22870 4. Management requirements 4.1 Organisation and management responsibility 4.2 Quality management system 4.3 Document control 4.4 Service agreements 4.5 Examination by referral laboratories 4.6 External services and supplies 4.7 Advisory services 4.8 Resolution of complaints 4.9 Identification and control of non - conformities 4.10 Corrective action 4.11 Preventive action 4.12 Continual improvement 4.13 Control of records 4.14 Evaluation and internal audits 4.15 Management review 5. Technical requirements 5.1 Personnel 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment, reagents and consumables 5.4 Pre-examination processes 5.5 Examination processes 5.6 Ensuring quality of examination results 5.7 Post examination processes 5.8 Reporting results 5.9 Information systems Management requirements provide the strength and support for the technical requirements
U.S. CLIA Regulations: CLIA (Clinical Laboratory Improvement Amendments) In U.S. ALL clinical testing must be under CLIA (www.cms.gov/clia/) U.S. POCT Sites This means you too!
CLIA (2003): QMS Requirements and QSEs A: General Provisions H: Participation in proficiency testing (EQA) K: Quality Systems Specialties/subspecialties General laboratory systems Pre-analytic Analytic Post-analytic M: Personnel Q: Inspection
CLIA s Quality System section focuses only on technical requirements Transmit result Record Result Patient Doctor Prepare request form Phlebotomy Report result Transport Time Validate result Quality control Analyze sample Prepare sample Register sample Preanalytical Analytical Postanalytical 22
493.1241-493.1249: Pre-analytical requirements Electronic or written request Oral requests must be followed by above Test request information Patient identifier, gender and age, test ordered, specimen source (if appropriate) and date and time (if appropriate) of collection, and required additional information Specimen submission, handling and referral policies Assessment of processes Follow policies to monitor, assess and correct problems
493.1251-493.1289: Analytical requirements Procedure Manual Test systems, equipment, instruments, reagents, materials, supplies Establishment and verification of performance specifications Maintenance and function checks Calibration and calibration verification Control procedures Comparison of test results Corrective actions Test records Assessment and correction of problems
493.1290-493.1299: Post-analytical requirements Test report System in place to ensure test results and patient data are accurately sent from the point of data entry to final report Appropriate reference intervals available to those who ordered the test and using test results Assessment Follow policies to monitor, assess and correct problems
U.S. CLIA Regulations A: General Provisions H: Participation in proficiency testing (EQA) K: Quality Systems Specialties/subspecialties General laboratory systems Pre-analytic Analytic Post-analytic M: Personnel Q: Inspection U.S. Government (CLIA) assumes: Testing sites complying with ALL CLIA requirements have a QMS in place
The ISO and CLIA QMS Models You say "either" and I say "either" You say "neither" I say "neither" "Either" "either", "neither" "neither" You say "potato," I say "patattah" You say "tomato", I say tomata Oh, let's call the whole thing off! Both CLIA and ISO mandate a QMS
QMS Model: ISO 15189 vs CLIA QMS ISO 15189 CLIA QSE Clauses Sections Organization 4.1 Organization and Management 4.2 Quality management system 4.15 Management review 493.1200-493.1299 Subpart K Quality System for Non-Waived Testing Personnel 5.1 Personnel 493.1351 493.1495 Subpart M Personnel for Non-Waived Testing Equipment 5.3 Laboratory Equipment 493.1252 493.1255 Equipment, performance verification, maintenance and function checks, calibration Purchasing & Inventory 4.4 Contract review 4.5 Referral Laboratories 4.6 External Services and Supplies 493.1242(8)(c) Specimen referral 493.1252 Test systems, equipment, instruments, reagents, materials, and supplies D. Howerton, Division of Laboratory Systems, CDC, CLIAC 09/06/07: Beyond CLIA Regulation: QMS International Guidelines & Standards
QMS Model: ISO 15189 vs CLIA Process Control QMS ISO 15189 CLIA QSE Clauses Sections 5.4 Pre-examination procedures 5.5 Examination procedures 5.6 Assuring quality examination 5.7 Post-examination procedures 493.1240-493.1249 Preanalytic systems 493.1250-493.1289 Analytic systems 493.1290-493.1299 Postanalytic systems Documents and Records Information management Occurrence management 4.3 Document Control 4.13 Quality and Technical Records 5.8 Reporting of results Annex B: LIS Annex C: Ethics 4.8 Resolution of complaints 4.9 Identification and control of nonconformities 4.10 Corrective action 493.1101(e) Facilities 493.1105 Retention Requirements 493.1290 493.1291 Post analytic Systems 493.1299 Post-analytic systems quality assessment 493.1256 493.1282 Control procedures D. Howerton, Division of Laboratory Systems, CDC, CLIAC 09/06/07: Beyond CLIA Regulation: QMS International Guidelines & Standards
QMS Model: ISO 15189 vs CLIA QMS ISO 15189 CLIA QSE Clauses Sections Assessments: Internal & External 4.11 Preventive action 4.14 Internal audits 5.6.4 External quality assessment 493.1250-493.1289 Analytical Systems 493.801 493.865 Participation in Proficiency Testing Subpart Q Inspection Process improvement 4.12 Continual improvement 493.1200, 493.1239, 493.1249, 493.1289, 493.1299 Quality Systems assessments Customer service 4.7 Advisory services 4.8 Resolution of complaints Annex C: ethics 493.1407, 493.1419 Consultation 493.1233 Complaint investigation 493.1234 Communication Facilities and Safety 4.6 External services and supplies 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment 493.1100 493.1101 Facility Administration for Nonwaived Testing 493.1252 Standard: Test systems, equipment, etc., D. Howerton, Division of Laboratory Systems, CDC, CLIAC 09/06/07: Beyond CLIA Regulation: QMS International Guidelines & Standards
10 Key Factors for Quality POCT* Start with a plan, e.g., Quality Management System Establish a framework, e.g., Quality System Essentials Train Make procedures easy to follow Make any needed tools understandable and available Automate where possible Assess for overall quality feedback from quality indicators Track events/occurances for continuous quality improvement Have a very visible POCT coordinator Nurture a quality and patient safety culture Santrach P. Mayo Clinic s 10 key factors for creating and maintaining a quality POC Program, October 2006, http://acutecaretesting.org/journalscanner?tid=61290154281
Quality Is Never An Accident! it is always the result of intelligent effort QMS for doing things right throughout the testing process
Merci beaucoup