Department of Pathology and Laboratory Medicine
Quality Assurance and Compliance Department
Recipe For Success- Key Ingredients
9 pins
Hospitals and Laboratories supported by the Quality and Compliance
Program:
Quality is the best business plan. Our team is here
to help you succeed.
Quality and Compliance Team
Members:
Dr. Julietta Fiscella
Fran Gersonia
Maimoona Ramaswamy
Lois Thom
Debbie Congdon
Heather Cote
Ross Petersen
Related Pins:
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
regulatory side.
The Quality Assurance Team is responsible and
works with all labs to :
Continuously monitor data on a periodic,
random basis
Provide ongoing training to personnel
Perform investigations if a problem is
detected
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
Soup
Ingredients:
Coding
Documentation
Medical
Necessity
Internal
Auditing &
Monitoring
All served with
a side of
alphabet soup:
External CT audit types:
pre-qualification, qualification, study specific & forcause
Our Role:
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
client auditor
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.
CLIA
CAP
ICH E6 GCP
GxP
In 2015:
The team performed approximately 65
internal audits
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
documents yourself.
Deferring to and locating the correct person
to answer the question asked within a
specified
time window is acceptable.
It takes a villageAssemble and rely on a
Team
ABN
MCD
CPI
NPI
HEAT
RAC
CMS
AKS
MCFU
CPT
OIG
HER
SCR
NGS
ALJ
MCR
CSP
OMIG
HHS
SMP
HCPCS
AO
MLN
DOJ
OPPS
ICD
SNF
PTAN
APG
NGS
DRG
PAO
IPPS
TOB
CERT
MPFS
EMR
PCS
LCD
UPIN
CLFS
NCCI
FCA
PQRS
LCSC
ZPIC
CMP
NCD
FI
PSC
MAC
NCCI
Clinical Laboratory
Evaluation
CAP Inspection
AABB inspection
FDA Inspection
(Blood Bank)
FACT Inspection
(Stem Cell/Blood
Bank)
ASHI inspection
(HLA Lab)
NYS Department of Health
(NYSDH)
College of American Pathologists
American Association for Blood
Banks (BB)
US Food and Drug Administration
Foundation for Accreditation
of Cellular Therapy
American Society of
Histocompatibility
& Immunogenetics
