How to improve Self - inspection, a primary CAP accreditation requirement, in order to achieve the best outcome

1. March 23-24, 2017 | Venue: Rosewood Hotel – Abu Dhabi
Licensed by

2. Improving the Quality and Value
of the Laboratory Self-Inspection
Ola H. Elgaddar
MD, PhD, MBA, CPHQ, LSSGB,
Lecturer of Chemical Pathology
Alexandria University
Ola.elgaddar@alexu.edu.eg

3. Disclosures
In compliance with the accrediting board policies,AACC requires the following disclosure to the
participants:
Grants/Research Support: None
Consultant: None
Other Financial or Material Support: None
Stock/Shareholder: None
Ola H. Elgaddar

4. Learning Objectives
After attending this presentation, you will be able to:
• Understand the Value of self – inspection in CAP
accreditation
• Describe the steps of an effective self - inspection
• Improve the self – inspection practice of your lab using
some simple tools

5. Do you like the term “INSPECTION”
1. YES
2. NO
3. I HAVE NO CHOICE

7. The College of American Pathologists (CAP) has
established and currently directs multiple
accreditation programs. The Laboratory
Accreditation Program (LAP) was established in
1961. In 1995, it received approval as an
accrediting organization under the Clinical
Laboratory Improvement Amendments of 1988
(CLIA) by the Centers for Medicare and Medicaid
Services (CMS)

8. Mission Statement:
“The CAP Accreditation Program improves patient
safety by advancing the quality of pathology and
laboratory services through education and standard
setting, and ensuring laboratories meet or exceed
regulatory requirements.”

9. Inspection:
On-site inspection by an external team and an
interim self-inspection are the cornerstones of the
CAP requirements.
Participating laboratories also provide an
inspection team when requested

10. Detailed list of requirements that the inspector uses to
determine if the laboratory meets the Standards.
Each requirement is uniquely numbered and indicated by
a declarative statement.
Revised periodically
Customized based on the laboratory’s activity menu.

11. Provided to participants upon completion of the initial
application, at accreditation mid-cycle during the self-
inspection year and at the time of each biennial re-
application.
A laboratory will be inspected using the checklist version
sent to it at the time of application/reapplication even
though a new version may have been released, and the
inspection team must utilize the same version that was
sent to the laboratory.

12. Self – inspection ….... Why??
A CAP requirement!!
To overcome human tendency to become
“familiar” with errors or with even error prone
activities.
Identify potential non-compliances and be ready
for the next inspection
Maintain and Improve lab performance and better
patient care

13. Self – inspection ….... What??
At the beginning of the second year of the two-year
accreditation cycle, using the assigned checklists.
Return the self-inspection verification form signed by the
director within 60 calendar days after receiving the self-
inspection materials.
Correct all cited deficiencies and document corrective
actions for review by the next CAP inspection team

14. Failure to perform the self-inspection is a serious
deficiency and may result in an immediate on-site
inspection or denial of accreditation.

15. Which of the following added disciplines, by
a CAP accredited lab, requires a self –
inspection:
1. Anatomic Pathology
2. Histocompatibility
3. Flow cytometry

16. Which of the following added disciplines, by
a CAP accredited lab, requires a self –
inspection:
1. Anatomic Pathology
2. Histocompatibility
3. Flow cytometry

17. The Self-Inspection deficiency corrective
action form should be returned to the CAP
within 60 calendar days:
1. True
2. False

18. The Self-Inspection deficiency corrective
action form should be returned to the CAP
within 60 calendar days:
1. True
2. False

19. How to improve the quality
and value of self – inspection?
Before (Prepare)
During (Conduct)
After (Improve)

20. Before
=
Prepare

21. Mimic the onsite inspection; Treat a self-
inspection like a real event.
CAP inspector and former Continuous Compliance Committee chair Renee R. Ellerbroek”
Formalize it: Policy, fixed time, conducted in one
day,…....

22. In order to formalize the self – inspection,
select a fixed date few months ahead, and
announce it for everyone:
1. Incorrect practice
2. Correct practice

23. In order to formalize the self – inspection,
select a fixed date few months ahead, and
announce it for everyone:
1. Incorrect practice
2. Correct practice

24. View the lab data on e-lab solutions for accuracy
and report any change to the CAP
Diversity of the team:
Involve all staff levels; bench technologists,
supervisors, managers and admins.
• Different perspective
• Confidence
• Sense of ownership

25. Encourage your staff to have the CAP inspector
training courses
Consider using a sister facility or cross-disciplines
for fresh unbiased opinions

26. During
=
Conduct

27. Start with reviewing the deficiencies cited during
the last inspection and make sure that the
corrective actions reported to CAP are actually
being implemented, otherwise they will come up
in the next inspection.

28. Use the latest CAP checklist; not the last on-site
inspection one and it might not be the next on-site
one as well.
Always check for updates and always follow up
the updates webinars offered by CAP

29. Use the CAP inspector “R.O.A.D”;
Read – Observe – Ask – Discover
Don’t forget the medical director assessment part
and focus only on technical part
Make it a thorough inspection!!

30. Focus review on new tests and methods, low
volume tests, and tests with unacceptable PT
results
Review last inspection recommendations and
decide if they should be implemented or not

31. After
=
Improve

32. Culture: Document everything that you find!!
Summation conference attended by all lab staff
from lab director downwards

33. Develop and implement a corrective action plan
for all the deficiencies that you found, follow up
the implementation of this corrective actions.
Give your self enough time before the next
inspection to make sure that corrective actions are
fully implemented and maintained

34. During the self-inspection of Clinical Chemistry, you noted that the
competency assessments of some staff were missing. You were
informed that competency assessments have been completed for
them but the unit manager had the files at home as he was working
on the annual evaluations.
What would you do?
1. Cite a deficiency since the competency assessment documents
are not in the laboratory.
2. Recommend that competency assessment documents should
not leave the laboratory.
3. Move on since the competency assessments have been
completed.

35. During the self-inspection of Clinical Chemistry, you noted that the
competency assessments of some staff were missing. You were
informed that competency assessments have been completed for
them but the unit manager had the files at home as he was working
on the annual evaluations.
What would you do?
1. Cite a deficiency since the competency assessment documents
are not in the laboratory.
2. Recommend that competency assessment documents should
not leave the laboratory.
3. Move on since the competency assessments have been
completed.

36. A final word:
On any day of the year ask yourself:
Are we ready for an unannounced
inspection??
If the answer is no then your self –
inspection is not effective!

37. Thank you