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Laboratory Inspections: How to ensure your lab will always meet the regulatory

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© APF and ASCP 2013

Laboratory Inspection: How to ensure your lab will always meet

the regulatory guidelines

1. Welcome

1.1 Welcome


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1.2 Title + Presenter Information


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1.3 Agenda


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1.4 Laboratory Structure


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1.5 MGUH Faculty and Staff


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1.6 Organizational Chart


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1.7 Laboratory Accreditation Agencies


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1.8 General CMS Standards for the Laboratory


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1.9 CLIA Regulations


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1.10 CLIA Regulations: Requirements


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1.11 CLIA Regulations: Quality Control


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1.12 CLIA Regulations: Proficiency Testing


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1.13 CMS Deemed Status Agencies


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1.14 Laboratory Accreditation Agencies

1.15 Knowledge Check

(Multiple Choice, 10 points, 3 attempts permitted)


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Correct Choice

Patient Confidentiality

Specimen identification & integrity

Complaint investigation

Personnel competency assessment

X All answers are general CMS standards for the laboratory.

Feedback when correct:

That's right!

Feedback when incorrect:

The correct answer is:

All are correct!


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2. Tips

2.1 Tips for working with Inspectors


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2.2 Additional Tips for working with Inspectors


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2.3 Tips for working with Inspectors: Dont's


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2.4 Tips for working with Inspectors: Documents


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2.5 Unannounced Inspections


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2.6 Responding to Laboratory Citations


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2.7 Themes for Laboratories in Trouble

2.8 Knowledge Check

(Pick One, 10 points, 3 attempts permitted)


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Correct Choice

Prepare inspection guides and instructions that several laboratory managers /

supervisors can follow in case the one true person is absent on inspection day(s)

Ensure that all material is reviewed before it is shared with the inspector

X Do not argue with inspector if you do not agree; contest the inspection finding

with the regulatory agency after the inspection has ended.


Excellent!




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Do not argue with inspector if you do not agree; contest the inspection finding with the

regulatory agency after the inspection has ended.

3. MedStar Laboratories

3.1 MedStar Health Laboratories: Mock CAP Inspection


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3.2 MedStar Health Laboratories: Proficiency Testing


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3.3 MedStar Health Laboratories: Peer Education


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3.4 MGUH'S work Practices to Comply with the Regulatory Needs:

Employees


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3.5 MGUH'S work Practices to Comply with the Regulatory Needs:

Documents


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3.6 MGUH Sharepoint Shapshot


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3.7 Proficiency Testing Requirements and Attestation


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3.8 Proficiency Survey Summary


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3.9 MGUH'S work Practices to Comply with the Regulatory Needs: CAP

Checklist Guide


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3.10 MGUH'S work Practices to Comply with the Regulatory Needs: Local

Implementations


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3.11 MGUH'S work Practices to Comply with the Regulatory Needs


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3.12 MedStar Georgetown University Hospital Laboratory: Quality

Management Coordinator

3.13 Knowledge Check

(Multiple Choice, 10 points, 3 attempts permitted)


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Correct Choice

Proficiency testing

Peer Education

Quality Control

X Mock CAP inspection is scheduled for all laboratories during their self-inspection

timeframe


That's right!



All are correct!


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4. Work Practices

4.1 Lessons Learned from Past Inspections


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4.2 Questions or comments?


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5. Conclusion

5.1 Congratulations!