Point of Care

1
Point of Care
Melissa Jordan, MT(ASCP)
April 16, 2008
2
What you need to know

• 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.

3
How does CLIA affect research?

• 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.

4
Example CLIA license
5
When might you need to utilize point of care
resources?

• As a basic rule, if you would make a decision
  based on the lab results you will be obtaining
  you need to follow CLIA.

6
What rules do you need to follow?

• If using Dr. Ryders CLIA license, there are 4
  key points.
• Point of Care needs to train you on the test
  youll 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).

7
Clarian POC Test Menu

• 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

8
Polices/Procedures

9
Example log for Urine Preg

• Body
• Text

10
Questions?