Department of Pathology and Laboratory Medicine Quality Assurance
Department of Pathology and Laboratory Medicine
Quality Assurance and Compliance Department
Recipe For Success- Key Ingredients
Hospitals and Laboratories supported by the Quality and Compliance
Quality is the best business plan. Our team is here
to help you succeed.
Quality and Compliance Team
Dr. Julietta Fiscella
What is Compliance?
Compliance is to the business side of
laboratories what the Clinical
Laboratory Improvement Amendments
(CLIA) of 1988 is to the analytical and
The Quality Assurance Team is responsible and
works with all labs to :
Continuously monitor data on a periodic,
Provide ongoing training to personnel
Perform investigations if a problem is
Notify providers/clients and reissues reports
if data/results are negatively impacted
QC vs. QA
QC refers to the procedures for the measures
that must be included during each assay run
to verify that the test is working properly.
This is a laboratory function.
QA refers to the overall program that ensures the
final results reported by the laboratory are
correct. QA activities are performed by staff
who are not directly involved with the analysis
of clinical samples.
Compliance is all about doing the right
thing: Pay the right amount to the right
provider for the right beneficiary for
the right reason for the right test.
Compliance and Regulatory
All served with
a side of
External CT audit types:
pre-qualification, qualification, study specific & forcause
Promote an environment of audit preparedness
Ongoing monitoring of CT study documents
Perform laboratory tracer audits
Perform mock- audits of study
Facilitate external audits
Encourage an information sharing approach with
Provide response to audit findings
Support resolution of audit finding resolution.
Clinical Trials sample is a one time opportunity
to capture specific information contained in the
specimen only at that specific time period.
ICH E6 GCP
The team performed approximately 65
The team participated and prepared for 5
NYS Inspections and 3 CAP inspections.
The team participated and prepared for 6
external client audits for clinical trials.
Tips for Successful Audit:
Respond to the question asked with simple,
honest, and complete answers.
Listen actively and ask for clarification if you
are unsure of what is being asked.
Dont rely on memory alone review the
Deferring to and locating the correct person
to answer the question asked within a
time window is acceptable.
It takes a villageAssemble and rely on a
NYS Department of Health
College of American Pathologists
American Association for Blood
US Food and Drug Administration
Foundation for Accreditation
of Cellular Therapy
American Society of
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