Transcript Document

Point of Care
Melissa Jordan, MT(ASCP)
April 16, 2008
What you need to know
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CLIA (Clinical Laboratory Improvement
Amendments)
www.hhs.gov
– The Centers for Medicare & Medicaid
Services (CMS) regulates all laboratory
testing (except research) performed on
humans in the U.S through CLIA.
– The objective of the CLIA program is to
ensure quality laboratory testing.
How does CLIA affect research?
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Typically, research is exempt from the
CLIA regulations, however, in the last
few years many researchers have been
asked for a CLIA license before being
allowed into the program.
– At Clarian, Dr. Ryder allows his CLIA
license to be used by research, if needed,
as long as the Clarian rules are followed.
Example CLIA license:
When might you need to utilize
point of care resources?
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As a basic rule, if you would make a
decision based on the lab results you
will be obtaining you need to follow
CLIA.
What rules do you need to follow?
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If using Dr. Ryder’s CLIA license, there are 4
key points.
– Point of Care needs to train you on the test you’ll
be using initially, at 6 months, and then annually
(call 274-0501).
– You can only use a kit from the Clarian supported
Point of Care test menu (slide 6).
– You need to know where to find the
polices/procedures for the POC tests (slide 7).
– You need adequate documentation of the test
results, date/time, lot numbers, etc. (slide 8).
Clarian POC Test Menu
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Point of Care (POC) Manual Index 2008
POC 01.002.07
Macroscopic Urinalysis by Chemstrip
POC 01.003.06
Fecal Occult Blood by SKD Hemoccult
POC 01.005.09
Measurement of Sodium, Potassium, Chloride, Urea Nitrogen,Glucose,
Hematocrit and Hemoglobin, Ionized Calcium, Creatinine, Activated
Clotting Time (ACT), Lactate, PT/INR, TCO2,Troponin, BNP, and Blood
Gases in Arterial and Venous Whole Blood by i-STAT and i-STAT 1 Testing Systems
POC 01.006.07
Blood Gases, Electrolytes, Glucose, BUN, Creatinine, Ionized Calcium, Hematocrit,
and Lactate by Blood Analysis Module (BAM)
POC 01.010.08
Specific Gravity by Refractometer
POC 01.015.08
Whole Blood Glucose by Accu-Chek Inform Glucose Meter
POC 01.018.02
Influenza A and B by BinaxNow
POC 01.019.02
Group A Streptococcal Antigen
POC 01.020.03
P2Y12 & Aspirin Response by Accumetrics VerifyNow
POC 01.021.02
Hemoglobin A1C by Bayer DCA 2000
POC 01.022.02
PSA by Qualigen FastPack® System
POC 01.024.03
THb and %HbO2 by ITC Avoximeter® 1000E
POC 01.025.02
Fern Test – Amniotic Crystallization Test by Microscope
POC 01.026.04
KOH Preparation and Wet Mounts for Vaginal Secretions by Microscope
POC 01.027.03
Detection of Rupture Membranes by AmniSure® ROM TEST
POC 01.028.02
Hemoglobin A1C by A1CNOW+®
POC 01.029.02
Urine Pregnancy Testing by Fisher Sure-Vue Serum/Urine hCG-STAT®
Polices/Procedures
Example log for Urine Preg
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Body
– Text
Questions?