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Individualized Quality Control Plan (IQCP) Program - iSTAT

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by

Maria Hardy, IMA (ASCP)

on 7 January 2015

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Transcript of Individualized Quality Control Plan (IQCP) Program - iSTAT

1. Does your lab perform non-waived testing?

2. Are you currently performing Equivalent Quality Control (EQC)?
As of January 1, 2016 EQC will no longer be acceptable and will be removed from the Interpretive Guidelines
Laboratories must choose between the Manufacturers required minimum of 2 levels of QC each day of testing or transition to IQCP
IQCP does not have the same requirements as EQC

Labs are already doing many of these activities, it’s just not formalized

CLIA & Individualized Quality Control Plan (IQCP)- CMS
Differences Between
EQC and IQCP
Updated Solution
Customizable
Flexible
Broader scope/More regulations
All but Pathology
Pre- through Post- Analytic
Does Not Require Internal QC
May/may not decrease QC

Components of an IQCP
Must Include the Entire Testing Process
Test System
Testing Personnel
Reagents
Specimen
Laboratory Environment
Results Reporting & Interpretation*
The IQCP program will assist you in meeting the following key objectives:

Perform a meaningful risk assessment
Customize your QC Plan according to test method, utilization, environmental factors, and personnel competency to produce a QC plan that is clinically and economically beneficial
Optimize your current QA/QC processes
Adhere to federal, state and accrediting organization requirements
Ensure continuous quality patient care, with optimal clinical outcomes
Identifying new initiatives and ongoing measures to improve the quality of patient care

Individualized Quality Control Plan (IQCP) Program
Prepare for the new
CMS/CLIA guidelines with
the software tool for
EVERY TEST IN YOUR LAB!

Transitional
Standardized
Rigid
Narrow scope/Limited regulations
Limited specialties
Analytic
Requires Internal QC
Decreases External QC
Pre-analytic - Analytic - Post-analytic
i-STAT System features single-use disposable cartridges that perform a broad menu of the most commonly performed diagnostic tests, including
cardiac markers, blood gases, chemistries and electrolytes, lactate, coagulation, and hematology
.
SPECIMEN: The
iSTAT
platform is suited for testing
waived
and
non-waived
anyaltyes.
i-STAT 1 System (300 series)
CHEM8+ Cartridge
Sample Type:
Waived
Venous whole blood samples collected in sodium or lithium heparin evacuated tubes (green top tubes) when run on the i-STAT 1 System.

Sample Type:
Moderate Complexity - IQCP Eligible
Arterial, capillary, or venous whole blood sample.

CLIA & Individualized Quality Control Plan (IQCP)- CMS
Questions:
This tool provides all laboratories a guide or roadmap on how to perform a risk assessment and develop an Individualized Quality Control Plan (IQCP)

Easy to use
Customizable
Documented records /report
Annual Subscription

Equivalent Quality Control (EQC)
EQC
IQCP
CLIA & Individualized Quality Control Plan (IQCP)- CMS
http://www.abbottpointofcare.com/Products-and-Services.aspx
How can IQCP help Abbott Customers?
PRE-ANALYTIC-
Blood Collection

ANALYTIC -
Loading the sample into the cartridge, Time to Test

POST-ANALYTIC -
Proper disposal of collection device
SPECIMEN i-STAT 1 System (300 series)
CHEM8+ Cartridge
Potential Sources of Error

Chemistry

Sodium (Na)

Potassium (K)

Chloride (Cl)

TCO2


Hematology/Coagulation

Hematocrit (Hct)

Hemoglobin* (Hgb)

Anion Gap*

Ionized Calcium (iCa)

Glucose (Glu)

Urea Nitrogen (BUN/Urea)

Creatinine (Crea)

For compliance Risk Assessments and IQCP's must be
created for each test system analyte
Full transcript