March 23-24, 2017 | Venue: Rosewood Hotel – Abu Dhabi

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Improving the Quality and Value of the Laboratory Self-Inspection

Ola H. ElgaddarMD, PhD, MBA, CPHQ, LSSGB,Lecturer of Chemical Pathology

Alexandria UniversityOla.elgaddar@alexu.edu.eg

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

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 usingsome simple tools

Do you like the term “INSPECTION”1. YES2. NO3. I HAVE NO CHOICE

The College of American Pathologists (CAP) hasestablished and currently directs multipleaccreditation programs. The LaboratoryAccreditation Program (LAP) was established in1961. In 1995, it received approval as anaccrediting organization under the ClinicalLaboratory Improvement Amendments of 1988(CLIA) by the Centers for Medicare and MedicaidServices (CMS)

Mission Statement:

“The CAP Accreditation Program improves patientsafety by advancing the quality of pathology andlaboratory services through education and standardsetting, and ensuring laboratories meet or exceedregulatory requirements.”

Inspection:

On-site inspection by an external team and aninterim self-inspection are the cornerstones of theCAP requirements.

Participating laboratories also provide aninspection team when requested

Detailed list of requirements that the inspector uses todetermine if the laboratory meets the Standards.

Each requirement is uniquely numbered and indicated bya declarative statement.

Revised periodically

Customized based on the laboratory’s activity menu.

Provided to participants upon completion of the initialapplication, 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 versionsent to it at the time of application/reapplication eventhough a new version may have been released, and theinspection team must utilize the same version that wassent to the laboratory.

Self – inspection ….... Why??A CAP requirement!!

To overcome human tendency to become“familiar” with errors or with even error proneactivities.

Identify potential non-compliances and be readyfor the next inspection

Maintain and Improve lab performance and betterpatient care

Self – inspection ….... What??

At the beginning of the second year of the two-yearaccreditation cycle, using the assigned checklists.

Return the self-inspection verification form signed by thedirector within 60 calendar days after receiving the self-inspection materials.

Correct all cited deficiencies and document correctiveactions for review by the next CAP inspection team

Failure to perform the self-inspection is a seriousdeficiency and may result in an immediate on-siteinspection or denial of accreditation.

Which of the following added disciplines, bya CAP accredited lab, requires a self –inspection:

1. Anatomic Pathology2. Histocompatibility3. Flow cytometry

Which of the following added disciplines, bya CAP accredited lab, requires a self –inspection:

1. Anatomic Pathology2. Histocompatibility3. Flow cytometry

The Self-Inspection deficiency correctiveaction form should be returned to the CAPwithin 60 calendar days:

1. True2. False

The Self-Inspection deficiency correctiveaction form should be returned to the CAPwithin 60 calendar days:

1. True2. False

How to improve the quality and value of self – inspection?

Before (Prepare)During (Conduct)After (Improve)

Before=

Prepare

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,…....

In order to formalize the self – inspection,select a fixed date few months ahead, andannounce it for everyone:

1. Incorrect practice2. Correct practice

In order to formalize the self – inspection,select a fixed date few months ahead, andannounce it for everyone:

1. Incorrect practice2. Correct practice

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

Encourage your staff to have the CAP inspector training courses

Consider using a sister facility or cross-disciplinesfor fresh unbiased opinions

During=

Conduct

Start with reviewing the deficiencies cited duringthe last inspection and make sure that thecorrective actions reported to CAP are actuallybeing implemented, otherwise they will come upin the next inspection.

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

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!!

Focus review on new tests and methods, lowvolume tests, and tests with unacceptable PTresults

Review last inspection recommendations anddecide if they should be implemented or not

After=

Improve

Culture: Document everything that you find!!

Summation conference attended by all lab staff from lab director downwards

Develop and implement a corrective action planfor all the deficiencies that you found, follow upthe implementation of this corrective actions.Give your self enough time before the nextinspection to make sure that corrective actions arefully implemented and maintained

During the self-inspection of Clinical Chemistry, you noted that thecompetency assessments of some staff were missing. You wereinformed that competency assessments have been completed forthem but the unit manager had the files at home as he was workingon the annual evaluations.What would you do?

1. Cite a deficiency since the competency assessment documentsare not in the laboratory.

2. Recommend that competency assessment documents shouldnot leave the laboratory.

3. Move on since the competency assessments have beencompleted.

During the self-inspection of Clinical Chemistry, you noted that thecompetency assessments of some staff were missing. You wereinformed that competency assessments have been completed forthem but the unit manager had the files at home as he was workingon the annual evaluations.What would you do?

1. Cite a deficiency since the competency assessment documentsare not in the laboratory.

2. Recommend that competency assessment documents shouldnot leave the laboratory.

3. Move on since the competency assessments have beencompleted.

A final word:

On any day of the year ask yourself:Are we ready for an unannouncedinspection??If the answer is no then your self –inspection is not effective!

Thank you