Presented toAspetar- Qatar Orthopaedic & Sports Medicine Hospital By Bilal Al-kadri, B.Sc., Dipl. Pharm.QA, http://kw.linkedin.com/in/balkadri OCT/2011
Outline Terms & definitions History of CAP United Labs Consulting Team Requirements common to Laboratory Standards for CAP accreditation Steps towards Accreditation Pre-Assessment Assessment Post-Assessment Benefits of CAP Accreditation Q&A
Terms & Definitions CAP “College of American Pathologists” PT “ Proficiency Testing” LAP “Laboratory Accreditation Program” QMS “Quality Management System” CMS “Centers for Medicare & Medicaid Services” QC “Quality Control” PM “Preventive Maintenance”
Terms & Definitions Discipline: Testing grouped within a major category of clinical laboratory science (e.g., Hematology, Microbiology, etc…) Deficiency: Noncompliance with a requirement of the accreditation checklist Consultant: One who provides professional advice or services on request Activity Menu: The list of all tests & non-test activities subject to inspection and accreditation
About CAP The world’s largest association composed exclusively of pathologists certified by the American Board of Pathology Serving more than 17,000 physician members today.
Every Number is a life 234 671 832 3 648 77 2398 888 999 EFFICIENCY QUALITY SAFETY GOLD EDUCATIONEXPERTISE STANDARD EFFICIENCY QUALITY SAFETY
History of CAP American Society of Clinical Pathologists (ASCP), established in 1922 American Board of Pathology (ABP), established in 1936 College of American Pathologists (CAP) formed at organizational meeting in 1946
History of CAP The College is an advocate for high-quality & cost effective medical care and is widely considered the leader in laboratory QA. ≈ 7000 laboratories are CAP accredited ≈ 23,000 labs are enrolled in PT programs
History of CAP “CAP 15189” A new program established by CAP in 2008 CAP 15189 complements CAP accreditation and other quality systems by optimizing processes to: Improve patient care Strengthen deployment of quality standards Mitigate risks & control costs
CAP Accredited Labs in Middle East: Qatar : 1 Lebanon : 1 Jordan : 2 Kuwait : 2 United Arab Emirates : 4 Kingdom of Saudi Arabia : 16
United Labs Consulting Team Mission To pilot and guide other medical labs in Kuwait and the Gulf region to participate into PT surveys provided by CAP, and therefore to seek accreditation by the College of American Pathologists.
United Labs Consulting Team Vision To educate and lead the local medical lab community on how quality should be built or embedded into work processes to ensure patient safety & care.
United Labs Consulting Team Role(s) Evaluating effectiveness of QMS to identify opportunities for improvements (OFIs) Assisting in identifying training needs and promoting a continual improvement process Advising & supporting in identifying appropriate processes needed
United Labs Consulting Team Role(s) Aiding client on QMS realization (or parts of it), giving advice or information. Assisting client to ensure QMS suitability. Illustrating the concepts concerning QM in a clear & understandable way. Communicating with all relevant personnel, involving them in QMS realization.
Requirements Common to all labsections: Proficiency Testing QM program Patient Safety Goals Quality Control Reagents Test Requirements Procedure Manuals Method Performance Specifications Instruments & Equipment
Proficiency Testing Participation is integral Alternative assessment semi-annually for tests which PT not available Investigating PT failure & Biases Corrective action following a PT failure
QM Program Must have a documented QM program to systematically ensure the quality of lab services for patient safety care & services. Concerns and complaints with respect to the quality of patient testing and safety must be a part of the QM plan.
Patient Safety Goals Improve patient & sample identification Improve verification/communication of life threatening or life altering information Improve the identification, communication, and correction of errors. Improve Integration and Coordination of Laboratory Patient Safety Role.
Quality Control QC procedures are performed in a clinical laboratory to ensure that patients results are reliable. Reliability refers both to: Accuracy (how close a test is, on average, to patients true results) & Precision (consistency of tests performed at different times).
Quality Control QC procedures may include the following: Monitoring variables within the laboratory, like water quality, glassware calibration, and instrument calibration, that may affect results Defining protocols for performing QC for each test procedure Participating in PT programs
Quality Control Graphing QC results Performing daily and periodic analysis of quality control data and charts Troubleshooting, documenting and keeping records for QC errors Performing routine maintenance of laboratory instruments
Reagents Must be properly labelled: content & quantity / conc. or titer storage requirements /expiration date date prepared or reconstituted New lots and shipments of reagent must be checked against old lots
Test Requirements Follow manufacturer instructions for: Test procedure & method validation Reagent storage, handling & validation Quality control performance Calibration verification Analytical measurement range validation Clinically reported range
Procedure Manuals Should include, as applicable: Test principle Clinical significance Specimen type(s) Required reagents Calibration Quality control Calculations Reference intervals Interpretation
Method Performance Specifications The lab must have data on each test’s accuracy, precision, analytic sensitivity, interferences, and reportable range )i.e. Analytic measurement range, or AMR) Retain data records while the method is in use (plus two years)
Instruments and Equipment Equipment should be acquired, calibrated, maintained, and used in accordance with the manufacturer’s instructions. Laboratory management should have a PM program & written procedures for calibration, maintenance, adjustments & performance monitoring.
CAP-LAP MissionTo improve patient safety by advancing the quality of pathology and laboratory services through education and standard setting, and ensuring laboratories meet or exceed regulatory requirements.” VisionTo be the world’s leader and innovator in Laboratory Accreditation
CAP-LAP Examines pre-analytical, analytical and post analytical aspects of quality management (QM) in the laboratory:Test methodologies EquipmentTest specifications Specimen handlingReagents Test reportingControls Self evaluationMedia External PT
CAP-LAP In addition it examines: Organization Personnel requirements Safety Document control & management Corrective action Preventive action Continual Improvement
Standards for CAP Accreditation Standard I – Director & Personnel Standard II – Physical Resources Standard III – Quality Management Standard IV – Administrative Requirements
1. Director & PersonnelSpecifies qualifications, responsibilities, and role of the laboratory director.Discusses which tasks & responsibilities may be assigned and the role of a consulting pathologist. Sub Clause 5.1 “Personnel” in ISO 15189:2007
2. Physical Resources Relates to space, instruments, reagents, furnishings, communication systems, supplies, ventilation, piped gases and water, public utilities and security. Sub Clause5.2 “Accommodation & environmental conditions”5.3 “Laboratory equipment” in ISO 15189:2007
3. Quality ManagementIncludes system validation, analytic QC, QM of pre- & post-analytic processes, PT, information management, communication to clinicians & patients.Sub Clause 5.4 “Pre-examination procedures” 5.5 “Examination Procedures” 5.6 “Assuring quality of examination procedures 5.7 “Post-examination procedures” 5.8 “Reporting of results” in ISO 15189:2007
4. Administrative Requirements Laboratories MUST comply with the requirements specified in the Terms of Accreditation and the CAP inspection checklists.
Standards for CAP Accreditation The specifics of how the Standards are applied to laboratories are found in the CAP Accreditation Checklists and Terms of Accreditation.
Terms of CAP Accreditation Have a written policy & procedure for investigating complaints. Effectively participate annually in a CAP- accepted PT program. Submit a completed Self-Inspection Form in the interim year.
Terms of CAP Accreditation Promptly notify CAP office: Whenever the lab is subject to investigation or inspection by federal agency. In case of changing in location, ownership, or directorship of the lab. When there is a change in the laboratory’s test menu, prior to beginning that testing.
Accreditation Process Responding to Deficiencies Accreditation Application Forms Supplemental Materials Administrative Terms of Accreditation Laboratory Disciplines PT Participation Activity Menu PT Performance Inspecting the Accreditation Checklists laboratory sections Self-Inspection Procedure Manuals Anniversary of Accreditation QC & PT records Instrument Records Test method validation studies PT Prerequisite Application
Pre-Assessment Phase Must submit: an application request form Laboratory Section pages for each Personnel forms for lab directors, pathologists, QA/QC personnel, etc… Supplemental materials: CVs, org chart Must enroll in PT program for each patient reportable-test and for affiliated labs.
Pre-Assessment Phase Must list all lab disciplines on the app: Laboratory General, Transfusion Medicine, Chemistry, Hematology, Microbiology, Immunology, Cytogenetics, etc… Must provide lab’s Activity Menu Scope of testing List of all reportable assays
Pre-Assessment Phase Info provided is CRITICAL, as it will be used to customize checklists. After processing the application, CAP will send the customized checklists to the laboratory. CAP inspector will use the same version of customized checklists during inspection.
CAP Checklists List of requirements to determine if the lab meets the standards Instrumental to guide the inspection and its interpretation Covers 3200 requirements which indicates current lab operations
CAP Checklists Laboratory General Anatomic Pathology Hematology Cytopathology Clinical Chemistry Cytogenetics Urinalysis Histocompatibility Toxicology Flow Cytometry Special Chemistry Molecular Pathology Microbiology Point of Care Transfusion Medicine Diagnostic Immunology
CAP Checklists Help paint a complete picture of lab current operations Provide guidelines for development of policies, procedures and processes Help ensure accurate, reliable test results Customize type of deficiency for each requirement
CAP Checklists Phase 0- Does not require a formal response though should be corrected by the laboratory. Phase 1- Does not seriously affect the quality of patient care or significantly endanger the welfare of a laboratory worker. Correction & a written response to the Cap are required, but not supportive documentation.
CAP Checklists GEN.41340 Phase I N/A YES NO When critical results are communicated verbally or by phone, is there a policy that laboratory personnel ask for a verification “read-back” of the results? NOTE: Transmission of critical results by electronic means (FAX or computer) is acceptable. If critical results are transmitted electronically, the laboratory should confirm receipt of the result by the intended recipient (e.g., by a phone call); however, no read- back is necessary.
CAP Checklists Phase 2- may seriously affect the quality of patient care or the health & safety of hospital or laboratory personnel. Correction requires both action plan and supportive documentation that the plan has been implemented.
CAP Checklists CHM.10466 Phase II N/A YES NO Is there a policy that prohibits referral of proficiency testing specimens to another laboratory? NOTE: Under CLIA-88 regulations, there is a strict prohibition against referring proficiency testing specimens to another laboratory. In other words, the laboratory may not refer a proficiency testing specimen to a laboratory with a different CLIA number (even if the second laboratory is in the same health care system).
CAP Checklists are NOT… A list to follow exclusively A source of “Yes” or “No” interview questions The official report of inspection findings
Assessment Phase The inspector will look at all type of documentation: QC records PT records Instrument maintenance records Procedure Manuals
Assessment Phase The inspector will ask open-ended questions as starting point to: Obtain large amounts of information Help understand the documentation Assess the laboratory’s understanding of the requirements. Eliminate the need to focus on checklist
Assessment Phase Follow the R.O.A.D Read/review documentation Observe procedures/technique Ask probing questions Discover the path of a specimen
QUALITY SAY DOWHAT WHAT PROVE IMPROVEYOU YOU IT IT DO SAY
CAP-LAP focus on Education The leading resource for information and education in the practice and science of pathology and laboratory medicine. Education in a variety of formats: Documents/Manuals Live Seminars/Webinars Scientific Resource Committees On-Site Inspections Interim Self-Assessments PT Monitoring
Benefits of CAP Accreditation Comprehensive Evaluations Test results should be always accurate Lab should maintain high level of services Expert Inspection Teams Multi-disciplinary teams of lab professionals Thorough inspection specific to section(s) Useful Inspection Tools Customized inspection checklists
Benefits of CAP Accreditation Compliance with Regulations Helps you meet & exceed CMS requirements Unparalleled Educational Opportunities Exchange of ideas & discussions Valuable inspection at the end Recognition as a top performer Leader committed to quality patient care 83% of top hospital community choose CAP
References & Contacts:www.cap.orgLaboratory Accreditation Manual, 2010 EditionISO 15189 2nd Edition, Medical LaboratoriesParticular requirements for quality &competence