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Coagulation Corner


Wednesday, June 4, 2008

Heparin, Safety and the Laboratory's Role

With all of the attention to heparin contamination, and the amount of people in the hospital exposed to the drug, it is no wonder that the Joint Commission (JCAHO) came out with a directive this year concerning patient safety and heparin utilization. Heparin comes in as number 3 on the dangerous drug list- Insulin being number 1, and morphine number 2. This drug is widely used with a high risk of patient injury including bleeding, heparin induced thrombocytopenia (HIT) and osteopenia. Errors include the need for dose adjustments, and frequent laboratory monitoring Because of heparins poor bioavailability, there is no dose response relationship. This means that if 2 different patients are given a bolus dose of heparin, there is no correlation as to how similar the APTT results may be. Heparin is absorbed through the GI tract, has a half life of about 90 minutes and is excreted by the kidneys, additional problems such as liver disease, lupus anticoagulants and elevated factor VIII's add to the challenge of monitoring this drug.

So what did JCAHO come up with?
They defined patient safety goals- which is a system design or intervention that has demonstrated the ability to prevent or mitigate patient harm stemming from the processes of health care. Several safety goals for 2008 apply to the laboratory. However, this particular goal regarding patient safety 3E states: "Reduce the likelihood of patient harm associated with the use of anticoagulation therapy." This was directed to the following departments:

  1. Ambulatory
  2. Critical Access Hospital
  3. Home Care
  4. Hospital
  5. Long Term care
  6. Office Based Surgery


Anyone see anything glaringly missing?
Ah yes, the laboratory - anyone think of us? That is where the testing is performed that gives them the value which provides the information to allow them to decide what course of action to follow. You would think that it would be important for us to be part of that decision process. Just in case you weren't aware this directive has a one year phase in period that includes: "defined expectations for planning, development and testing (milestones) at 3 months (April 1, 2008- have you been aware of this in your institution?) 6 months (July 1, 2008) and 9 months (October 1, 2008), with full implementation by January 2009." I am sure you have nothing else on your plate, this should be a piece of cake!

There are several implementation expectations that will be much more effectively understood, utilized and effective with input from the laboratory. Either the director of coagulation, or a supervisor should sit on this committee. The directives include: (Bolded information are questions you might want to consider as part of the committee.)

  • (M) C 4. The organization uses approved protocols for the initiation and maintenance of anticoagulation therapy appropriate to the medication used, the condition being treated and to the potential for drug actions.
    • QUESTIONS TO CONSIDER:
      • ARE THE CLINICIANS PROVIDED WITH A CORRECTLY OBTAINED HEPARIN THERAPUTIC RANGE THAT REFLECTS THEINSTRUMENT/REAGENT COMBINATION USED IN THE LABORATORY? DO THEY UNDERSTAND THE VALIDITY OF THAT PROCESS OR ARE THEY STILL USING 1.5-2.5 TIMES THE MEAN OF THE NORMAL RANGE?
      • ARE DIRECT THROMBIN INHIBITORS (DTI's)USED IN THE HOSPITAL?
      • DO YOU KNOW HOW YOUR REAGENTS PERFORM - RESPONSE IS REAGENT DEPENDENT?
      • DOES YOUR REAGENT FLATTEN OUT WHEN THE DOSE IS HIGHER, THEREFORE UNABLE TO DETECT A DIFFERENCE IN THE HIGHER RANGE?
      • DO YOU HAVE A WELL DEFINED CURRENT NORMAL RANGE, AND WAS THE GEOMETRIC MEAN USED FOR THE INR?
  • (M) A 5: For patients started on warfarin, a baseline INR is available and for all patients receiving warafin therapy a current INR is available and is used to monitor and adjust therapy.
    • QUESTIONS TO CONSIDER:
      • WHERE DID THAT BASELINE INR COME FROM, WAS IT FROM A CLINIC, DOES THAT CORRELATE WITH YOUR INSTRUMENT?
      • WHEN YOU ARE TRANSISITIONING A PATIENT FROM A DTI TO WARFARIN, THE INR MAY NOT BE ACCURATE, A CHROMGENIC X ASSAY IS BETTER.
  • (M) C 8: The organization has a policy that addresses baseline and ongoing laboratory tests that are required for heparin and low molecular weight heparin therapies.
    • QUESTIONS TO CONSIDER:
    • CAN YOU PROVIDE ANTI-Xa ASSAYS ON PATIENTS THAT REQUIRE MONITORING ?
      • LUPUS
      • PREGNANCY
      • EXTREME THIN OR OBESE
      • PEDIATRIC PATIENTS
      • ORTHOPEDIC
      • SEVERE TRAUMA
  •  
    • CAN YOU TEST FOR LUPUS?
    • HIGH FACTOR VIII'S WHICH CAN SHORTEN YOUR APTT, MAKING MONITORING DIFFICULT?
    • CAN YOU PROVIDE ANY TESTING FOR DTI's? HOW DO YOU HANDLE THEM?
  • (M) C 9: The organization provides education regarding anticoagulant therapy to staff, patients and family.
    • QUESTIONS TO CONSIDER:
      • HAS ANYONE EVEN SEEN THE LABORATORY?
      • DO THEY UNDERSTAND THE ROLE THAT WE PLAY IN THIS PROCESS (AND THAT WE WERE ELIMINATED FROM INPUT BY JCAHO!)
      • DOES YOUR STAFF UNDERSTAND ABOUT THE INR?
      • AN IN REFERENCE TO PRE-ANALYTICAL VARIABLES- REMEMBER THAT AN APTT IS ONLY GOOD FOR 4 HOURS, AND IF A PATIENT IS ON HEPARIN, IT SHOULD BE SPUN WITHIN 2 HOURS. IF THE PLASMA SITS ON THE RED CELLS, THE PF4 FROM THE PLATELETS WILL NEUTRALIZE THE HEPARIN, AND FALSELY DECREASE RESULTS.
      • DO STAFF UNDERSTAND WHEN A SAMPLE SHOULD BE DRAWN AFTER A DOSE IS GIVEN?
      • THAT A THROMBIN TIME CAN BE DONE IF A PHYSICIAN IS INSISTING THAT A HEPARIN LEVEL SHOULD BE ATTAINABLE, IF THE THROMBIN TIME IS NORMAL THERE IS NO HEPARIN IN THAT SAMPLE, IT IS THE BEST TEST FOR RESIDUAL HEPARIN?

Let's hope that institutions realize how complicated this process is, but if communication between departments can be optimized, and the laboratory and the knowledge of the technologists be utilized. Patients will be assured to have safe and accurate results.

Donna Castellone

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About the Author

Donna Castellone,  MS, MT(ASCP)SH

Donna Castellone,
MS, MT(ASCP)SH

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