This document provides an overview of CAP accreditation for laboratories. It defines key terms, outlines the history of CAP, and describes the United Labs Consulting Team. It reviews common laboratory requirements and CAP standards. The steps for accreditation include pre-assessment, assessment, and post-assessment phases. Benefits of CAP accreditation include comprehensive evaluations, expert inspection teams, useful inspection tools, and compliance with regulations. CAP focuses on continuous education to improve laboratory quality and patient safety.
Clinical laboratory total quality management (TQM) systemTapeshwar Yadav
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Quality system essential elements
The history of development of quality principles
Discuss relationship of this quality model to ISO and CLSI standards
Recently ISO 15189:2022 have become available. This would help laboratories set up processes which would yield reproducible results and improve the quality of work.
Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
Clinical laboratory total quality management (TQM) systemTapeshwar Yadav
Generally, management can be defined as “an ongoing process that seeks to achieve the objectives of an organization in the most efficient ways possible”.
Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency.
Medical laboratory work is composed of the technical activities that produce laboratory results for patient care and the management activities that support the technical work.
It is the job of the laboratory technical staff to perform pre-analytic activities, analytic activities and post analytic activities that transforms a clinician’s order for a laboratory test.
What is quality?
Importance of a quality management system in the laboratory
Quality system essential elements
The history of development of quality principles
Discuss relationship of this quality model to ISO and CLSI standards
Recently ISO 15189:2022 have become available. This would help laboratories set up processes which would yield reproducible results and improve the quality of work.
Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
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This is a series of notes on clinical pathology, useful for postgraduate students and practising pathologists. It covers all internal and external quality control techniques. The topics are presented point wise for easy reproduction.
Global Manager Group has prepared presentation to provide information about Medical Laboratory Accreditation Standard - ISO 15189 and about Documentation kit. All the documents like quality manual, procedures, SOPs, audit checklist, etc that required for the ISO 15189 Certification process. are described in details in this presentation.
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1. Presented to
Aspetar- Qatar Orthopaedic & Sports
Medicine Hospital
By
Bilal Al-kadri, B.Sc., Dipl. Pharm.QA,
http://kw.linkedin.com/in/balkadri
OCT/2011
2. 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
3. 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”
4. 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
5. 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.
6. Every Number is a life
234 671 832 3 648 77 2398 888 999
EFFICIENCY QUALITY SAFETY
GOLD EDUCATION
EXPERTISE
STANDARD
EFFICIENCY QUALITY SAFETY
7. 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
8. 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
9. 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
10.
11. CAP Accredited Labs in Middle East:
Qatar : 1
Lebanon : 1
Jordan : 2
Kuwait : 2
United Arab Emirates : 4
Kingdom of Saudi Arabia : 16
12. 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.
13. 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.
14. 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
15. 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.
17. Requirements Common to all lab
sections:
Proficiency Testing
QM program
Patient Safety Goals
Quality Control
Reagents
Test Requirements
Procedure Manuals
Method Performance Specifications
Instruments & Equipment
18. 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
19. 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.
20. 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.
21.
22. 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).
23. 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
24. 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
25.
26. 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
27. 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
28. Procedure Manuals
Should include, as applicable:
Test principle
Clinical significance
Specimen type(s)
Required reagents
Calibration
Quality control
Calculations
Reference intervals
Interpretation
29. 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)
30. 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.
31.
32. CAP-LAP
Mission
To 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.”
Vision
To be the world’s leader and innovator in
Laboratory Accreditation
33. CAP-LAP
Examines pre-analytical, analytical and post
analytical aspects of quality management
(QM) in the laboratory:
Test methodologies Equipment
Test specifications Specimen handling
Reagents Test reporting
Controls Self evaluation
Media External PT
34. CAP-LAP
In addition it examines:
Organization
Personnel requirements
Safety
Document control & management
Corrective action
Preventive action
Continual Improvement
35.
36. Standards for CAP Accreditation
Standard I – Director & Personnel
Standard II – Physical Resources
Standard III – Quality Management
Standard IV – Administrative Requirements
37. 1. Director & Personnel
Specifies 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
38. 2. Physical Resources
Relates to space, instruments, reagents,
furnishings, communication systems,
supplies, ventilation, piped gases and
water, public utilities and security.
Sub Clause
5.2 “Accommodation & environmental conditions”
5.3 “Laboratory equipment” in ISO 15189:2007
39. 3. Quality Management
Includes 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
40. 4. Administrative Requirements
Laboratories MUST comply with the
requirements specified in the Terms of
Accreditation and the CAP inspection
checklists.
41.
42. 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.
43. 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.
44. 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.
45. 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
46.
47. 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.
48. 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
49. 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.
50. 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
51. 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
52.
53. 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
54. 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.
55. 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.
56. 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.
57. 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).
58. CAP Checklists
are NOT…
A list to follow exclusively
A source of “Yes” or “No” interview
questions
The official report of inspection findings
59.
60. Assessment Phase
The inspector will look at all type of
documentation:
QC records
PT records
Instrument maintenance records
Procedure Manuals
61. 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
62. Assessment Phase
Follow the R.O.A.D
Read/review documentation
Observe procedures/technique
Ask probing questions
Discover the path of a specimen
64. QUALITY
SAY DO
WHAT WHAT PROVE IMPROVE
YOU YOU IT IT
DO SAY
65. 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
66. 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
67. 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