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

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.

16. TEAMWORK

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.

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

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.

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

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.

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

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

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

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

63. Post-Assessment Phase
 Responding to Deficiencies
 Accreditation
 Maintaining Accreditation:
 PT participation
 Monitoring PT scores
 Self-inspection
 Anniversary of Accreditation

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

69. References & Contacts:
www.cap.org
Laboratory Accreditation Manual, 2010 Edition
ISO 15189 2nd Edition, Medical Laboratories
Particular requirements for quality &
competence