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Keys to Getting a Good Fingerstick and Capillary Blood Sample
Doing a proper fingerstick is essential to getting good results on any device for Point-of-Care testing
MAXIMIZE GOOD BLOOD CIRCULATION
• Warm the hand by washing in warm water or holding it in a heating pad or hand warmer for a couple of minutes.
• Massage the finger with a downward motion several times before performing the fingerstick.
• Lower the hand to below the heart level when collecting the drop of blood.
USE THE RECOMMENDED LANCET DEVICE
We recommend a 21 gauge, single use lancet device. If you are still having trouble, you can try using a 19 gauge lancet.
CHOOSE THE RIGHT SPOT
Choose a spot that is on
the bottom side of the
tip of one of the center
fingers of either hand.
(You should check to be sure that the
blood will easily drop onto the Test Strip
before you perform the fingerstick)
TRY USING A MICROSAFE CAPILLARY COLLECTION TUBE
A capillary collection tube can help draw
the correct amount of blood, and can make
it easier to apply the sample to the Test Strip.
COLLECT AND APPLY AN ADEQUATE SAMPLE TO THE STRIP
Release pressure and repeat, if necessary, to collect a
Quickly express blood down toward the
large hanging drop of blood. Immediately apply one
finger by gently squeezing across the entire
drop to the sample well on the strip. Do not add a
finger, at the last joint, not the fingertip.
second drop after the first drop is applied.
Do not "milk" the finger.
• Healthcare professionals should always wear gloves.
• The meter should be on a level surface, and not moved or touched during testing.
• If you need to repeat the test, perform a new fingerstick.
HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134 1-877-436-6444 toll free (408)719-1393 tel (408)719-1184 fax www.hemosense.com
© 2005 HemoSense, Inc. All rights reserved. PN 0200189 Rev F
Training Materials
TRAINING-IN-A-BINDER
Contents
Chapter 1 – Instructor and Site Preparation…………… 2
Chapter 2 – Description of the Meter and Strip……...… 4
Chapter 3 – How to Change the Meter Setup………..… 8
Chapter 4 – How to Perform a Test…………….……..…10
Chapter 5 – Troubleshooting………………….……...… 14
Chapter 6 – Finishing the Training………………...…… 16
Chapter 7 – Forms…………………………………......…17
Chapter 8 – Your Site Specific Information………..…… 18
Contact Information
Technical Support and
Customer Service
Toll Free: 1.877.436.6444
Technical Support: 24 hours/day, 7 days/week
Customer Service: 7am-5pm pst, Monday-Friday
HemoSense Inc.
651 River Oaks Parkway
San Jose, CA 95134 USA
phone:
fax:
website:
email:
408.719.1393
408.719.1184
www.hemosense.com
service@hemosense.com
©2005 HemoSense Inc. All rights reserved. Made and printed in the USA. PN 0200263 RevC
1
Chapter 1 – Instructor and Site Preparation
Preparation for Training
Before training in person or over the telephone, ensure that the site is prepared.
This section covers setting up the class, training materials and supplies.
Call to set up an appointment for training and review the Class Guidelines below.
After setting up the appointment, FAX or email the Training Letter to the customer.
The Training Letter contains a checklist of the Class Guidelines outlined below.
Request the site have the trainees view the video and review the other training material
prior to the training.
Setting up the Class:
Training Area:
Ensure the site has sufficient space for the trainer, trainees, training materials and supplies.
There should be enough space for participants to take notes and to practice with the
INRatio meter.
A flat, stable work surface is required to run the meter. The temperature of the room
should be between 50°F and 95°F.
Scheduling:
The suggested time for the training is 1 hour. It is recommended to schedule 1.5 hours to
allow for adequate practice of the fingerstick technique and for questions. Factor in
additional time if review of site policies and procedures is required.
Class Size:
The recommended class size is four to six participants.
Training Materials:
HemoSense Training Materials:
INRatio Professional Instruction Video: The video runs approximately 10 minutes and
provides step by step instructions for setting up the meter, performing a fingerstick,
running a test and cleaning the meter.
INRatio Professional User’s Guide: The User’s Guide is provided with each INRatio Kit. It is
the primary reference for users of the device.
Inserts: Separate package inserts are provided with the strips, lancing devices and micro
capillary tubes. Note: for the Unistick®2 Extra single use lancing device, the instructions for
use are printed on the box.
INRatio Quick Reference Guide: A Quick Reference Guide is provided with every kit which
instructs the user in a number of easy steps how to obtain a test result.
Refer to the User’s Guide, Package Inserts and Quick Reference Guide frequently
throughout the training to familiarize the user with where additional information may be
found.
2
Other Training Materials:
This training binder may be customized further by adding training materials e.g.
overheads, handouts, additional information, site policies etc. Extra tabs are provided to
make this easier. Please indicate the institution’s name or logo on this extra material to
distinguish it from the HemoSense provided materials.
Check with the site being trained if they would like to review their Policies and Procedures
prior to beginning the product training.
Ordering Additional Training Materials:
To order additional copies of the training material please contact HemoSense Customer
Service at 1-877-463-6444.
Supplies:
Make sure that the site has received their system before performing the training. In
addition, if the training is being held in person at the site, take with you demo meters plus
strips and other supplies. Allow for one demo meter per two trainees. The following is the
list of supplies that should be available for the training:
- INRatio Meter
- INRatio Test Strips
- Lancing Device and Lancets
- Micro-capillary Tubes
- Gauze and Alcohol Swabs
- Latex Gloves
- Biohazard Disposal Container
- INRatio Professional User’s Guide
- Package Inserts for Strips, Lancets and Micro-capillary Tubes
- Quick Reference Guide
General Instructions
1. When performing training follow the structure of the training material in this
binder.
2. Convey the information outlined in each section and demonstrate where in the
product labeling (User’s Guide and or Package Inserts) the information can be
found. Use examples and analogies as appropriate.
3. The
N symbol indicates information that should be shown or explained to the
trainees.
4. The
symbol indicates information that should be stressed and reemphasized multiple times during the training.
5. As you complete each section ask the questions at the end of the section and
assure yourself that the trainees are familiar with the answers. Ask other questions
as appropriate.
6. Complete your copy of the check list as you go to indicate you have covered all the
relevant sections. Fill in the name of the institution and the date of the training.
Sign the checklist and keep it for your records.
i
3
Chapter 2 – Description of the Meter and Strip
Understanding the System
This section covers descriptions of the meter, strip, operating conditions and safety.
-Begin the class by viewing the video if the trainees have not already done so.
-Review the components of the kit and the features of the meter and strip.
-Review the operating and storage conditions for the meter and strip.
N Show trainees where more information can be found in the User’s Guide sections
“Principals of Operation”.
Professional Kit Components
Describe each of the components of the kit, Power Supply, Quick Reference Card, User’s
Guide, Lancets, Training Video, and Warranty Reply Card.
The Meter
1. Instruct the trainees to turn the Meter so that the back faces them.
Point out the Power Jack and the Data Port.
i Explain that the Power Jack is only to be used with the HemoSense Power Supply
provided with the kit.
2. Instruct the trainees to turn the meter upside-down. Point out the Serial Number, the
Battery Door Release, the Battery Door and the telephone number for Technical
Support. Explain how to open the Battery Door to install the batteries.
Specify the number and type of batteries to be used.
N Show trainees where information on Installing Batteries can be found in the
User’s Guide.
3. Point out the important features of the Meter, the Display, the OK, MENU and
UP/DOWN Buttons, the Cleaning Door, the Test Strip Guide and the Sample Light.
4. Point out that the meter requires no maintenance other than routine cleaning. Explain
and demonstrate how to perform cleaning. Include discussion of site cleaning policy
as required e.g. after every test, once per day, once per week.
N Show trainees where information on Maintenance and Cleaning can be found in
the User’s Guide.
i Caution that the meter should not be immersed in liquid and that abrasive
cleaner should not be used.
The menu button:
a) May be used to turn on the meter.
b) Accesses the meter menu.
c) Accesses the memory functions of the meter.
d) All of the above.
4
The Strip
1. Point out the important features of the Strip, the Electrodes, the Test Areas and the
Sample Well. Explain where the blood is applied and how it runs up the track to the
test area.
2. Point out the two QC channels and explain that each time a test is run with the
patients’ sample a normal and a therapeutic QC is automatically run at the same time.
Explain that the results can be recorded and that because of these on-strip controls
there is no need for external liquid controls. Point out that the ranges for QC for each
strip lot can be found on the HemoSense web site (See Chapter 8).
3. Explain that when QC values are displayed without an error message, the meter and
strip are working properly and the testing was done using acceptable techniques.
Explain that when a QC error is displayed the controls are out of range and a series of
Troubleshooting steps will need to be taken. Troubleshooting will be discussed in a
separate section.
N Show trainees where this information can be found in the User’s Guide section
“Principals of Operation” and “Quality Control”.
1. How many channels are on the test strip?
2. How many controls are on the test strip?
Operating and Storage Conditions
Review the proper operating and storage conditions for the meter and the strip. Point to
where these conditions may be found in the Strip Package insert and in the User’s Guide.
Explain that to ensure the accuracy of the test results, the system should be operated in
proper conditions and the strip should be stored carefully in the appropriate
environmental conditions. Review all of the operating and storage conditions in the
following sections.
i Stress the importance of this information and emphasize the fact that the results may
not be accurate if these conditions are not adhered to.
Meter Operating Conditions
Instruct trainees on the following:
Do:
• Perform testing at Room Temperature between 50°F and 95°F.
• Perform testing at a Relative Humidity between 10% and 95%, without
condensation.
• Make sure the meter is at room temperature before use.
• Test with the meter on a level surface that is free of vibration.
• Transport the meter in the original container or another secure container.
Do not:
• Do not perform testing below 50°F or above 95°F.
5
•
•
•
•
•
Do not perform testing where there is condensation e.g. a steamy bathroom
Do not bring the meter to the patient’s finger. Bring the finger to the meter. If this
is not possible use a micro-capillary tube.
Do not perform testing where the surface is uneven such as a bed or a person’s lap.
Do not perform testing on a vibrating surface such as in a car or an airplane.
Do not drop the meter or treat it roughly by carrying it around unprotected in a
briefcase or a purse.
N Show trainees where this information can be found in the User’s Guide sections
“Introduction”, “Principals of Operation” and “Operational Precautions and Limitations”.
To run a test you can hold the meter in your hand while
applying the sample as long as you set it down within 10
seconds.
True or False?
Strip Storage Conditions
Determine what the site policy is for storing strips. Depending on the policy (some sites
do not want to give the option of refrigeration) emphasize the preferred storage method.
Instruct trainees on the following:
Do:
• Store the strips at Room Temperature, below 90°F, until the expiration date.
• If desired, store the strips refrigerated, 35°F to 45°F, until the expiration date.
• If refrigerated, allow the sealed pouch to come to room temperature for 5 minutes
before opening for testing.
• Store the strips in their original container.
• Use the test strip within 10 minutes of opening the foil pouch.
Do not:
• Do not leave the strips in conditions above 90°F such as your car in the summer
time or on a window ledge in the sun.
• Do not freeze the strips
• Do not use the strips after the expiration date printed on the pouch.
Point out where the expiration date may be found on the box and on the pouch.
N Show trainees where this information can be found in the Strip Package Insert
section “Storage and Handling”.
1. How long can test strips be stored:
a) Until the expiration date on the box.
b) For six months.
c) For three months or until the expiration date
on the box, whichever comes first.
d) Indefinitely.
2. How long can the strip be out of the pouch before
performing a test?
6
Safety
N Show trainees where this information can be found in the User’s Guide section
“Hazards”.
i Important Points to Emphasize and Repeat
? Always perform testing on a flat, level surface.
? Always store and use the strips under the recommended conditions.
7
Chapter 3 – How to Change the Meter Setup
Main Menu
Instruct the trainees to turn the meter on by pressing any button. Point out the Self Test
Screen. Note this screen only appears for X seconds and is then replaced by the Insert
Strip Screen.
Explain that pressing the Menu Button at this point will take you to the main menu. Point
out that there are a number of options, Review Memory, Print Memory, Change Setup,
Turn Meter Off and Run Test.
Spend some time reviewing each of these options and explaining the choices available.
N Show the trainees where they can find this information in the User’s Guide section
“Main Menu Functions”.
Review Memory
Explain that the meter automatically saves the test results in memory and that this option
allows review of past test results. Point out that the meter can store up to 60 time and
date stamped results at any one time and that when the memory is full, the first result will
be lost when a new one is recorded.
N Explain that pages 23 and 24 of the User’s Guide show the screens that will appear in
the Review Memory menu.
Print Memory
Explain that this option allows the memory to be printed and that a printer is available for
purchase from HemoSense or their distributors. Explain also that the “Printer Operating
Instructions” should be followed for set up and operation for the printer.
Change Setup
Explain how to set the various options in the Change Setup menu, Time and Date, Units,
Target, Printer, Language.
Point out that if the site requires QC to be recorded then the units should be set to the
INR+PT+QC. Otherwise the INR option is appropriate for most situations. Ask the site
which units are required to be displayed per their policy and emphasize this screen.
i Stress the importance of recording the correct units in the log sheet. Recording a PT
seconds value of 12 as an INR value can lead to inappropriate treatment decisions.
N Explain that pages 25 to 39 of the User’s Guide show the screens that will appear in
the Review Memory menu. Explain that these pages walk through the steps to change
each of the setup options.
8
Turn Meter Off
Explain how this option allows the meter to be turned off.
Point out that the meter will automatically turn itself off after 10 minutes of inactivity in
the Main Menu in order to save batteries.
To turn off the INRatio meter:
a) Wait 10 minutes, and it will turn off by itself.
b) Press the menu key, scroll down to "TURN
METER OFF" and press the OK button.
c) Since there is no on/off button, it must be
unplugged.
d) Both a. and b.
Run Test
Explain that this option will return the user to the testing menu to the Insert Strip screen.
i Important Points to Emphasize and Repeat
? Check that the units being recorded are correct.
9
Chapter 4 – How to Perform a Test
Performing a Test
This section covers the steps for performing a test including preparations, performing a
fingerstick, applying the sample, reading and recording the results.
After walking through the steps, instruct the trainees to break into pairs and perform a
fingerstick on each other. Observe the fingerstick technique and provide instruction
throughout the process
Preparing to do a Test
Instruct the trainees on the steps necessary to prepare for the test.
1. If the strip has been refrigerated allow it to come to room temperature for 5 minutes
before opening the pouch. (Remember site policy on storage. If room temperature
storage is required, ignore this step).
2. Prepare the lancing device and set aside until ready to do the test.
Note: Instruct the trainees how to prepare the lancing device at this point.
i Stress the importance of using the recommended lancing device with 21 gauge
lancet (Unistick®2 Extra for single use or auto-Lancet™ Device for multiple use).
Point out that a lancing device/lancet for a blood glucose meter will not produce
enough blood for an INRatio test.
N Show the trainees where they can find instructions for use in the Lancing Device
Package Insert.
3. Place the meter on a flat, stable surface like a table and turn it on using any button.
Note: Inform the trainees about the self-test and software version on the Self-Test
screen.
4. Wait for the Insert Strip screen to appear.
5. Open the pouch, remove the test strip and insert it into the meter. The Strip Code
screen will appear.
Note: Instruct the trainees on how to insert the strip correctly using the strip guides
and making sure the words on the strip are readable by the user.
Point out the green sample light in the sample well.
i Stress the importance of using the strip within 10 minutes of opening the pouch.
6. Compare the strip code on the pouch with the one displayed on the screen.
Note: Instruct the trainees on how to change the strip code.
i Stress the importance of entering the correct strip code. Point out that the results
may be inaccurate if the code in the meter does not match the code assigned to the
strips.
10
7. Wait for the Apply Sample screen.
Note: Point out that the system is now ready to do a test. Explain that there is a 5
minute window from this point to do the Fingerstick and apply the sample before the
meter times out. Explain also that there is a 10 sec window at the end of the 5 minute
period within which pressing any button will reinstate the Apply Sample screen.
N Show the trainees where to find these steps in the User’s Guide in the section
“Performing a Test”.
1. If the strip code displayed on the meter DOES NOT
match the strip code number (the code in bold print on
the outside of the strip pouch), you should:
a) Discard that strip and find one that matches.
b) Use the strip anyway.
c) Correct the code on the meter display by
using the "up/down" arrow key.
d) Call HemoSense Technical Support.
2. If the test strip is inserted upside down:
a) It will break the meter.
b) The meter will not recognize that a strip has
been inserted.
c) The meter will run a test anyway, and the
results will be correct.
d) The meter will run a test anyway, but the
results may be erroneous.
Performing a Fingerstick
Review the steps necessary to obtain an adequate sample from a fingerstick. A minimum
sample size of 15uL is required in a large hanging drop. Use examples to describe a large
hanging drop or demonstrate on yourself and show them what the drop should look like.
N Show the trainees where to find these steps in the User’s Guide in the section
“Collecting a Fingerstick Sample”. Hand out the sheet “Tips for Obtaining a Good
Fingerstick Sample” and use it to walk through the steps.
1. Increase the circulation to the hand.
Note: Instruct the trainees how to increase circulation using the tip sheet and the
User’s Guide.
2. Select a site on the finger, clean with alcohol and dry thoroughly.
Note: Instruct the trainees on how to choose a site, clean and dry using the
instructions in the tip sheet and the User’s Guide.
i Stress the importance of drying the site after wiping with alcohol. Point out that if
not dried correctly, a large hanging drop will not form and the blood will smear on the
11
finger. The site may sting when the fingerstick is performed if there is still alcohol on
the finger.
i Stress the importance of using the recommended Alcohol Swabs i.e. alcohol only.
Using swabs with lanolin or other additives may interfere with the test results.
3. Puncture the finger with the lancet following the instructions for the lancet being
used.
4. Apply gentle, continuous pressure until a large hanging drop forms.
Note: Instruct the trainees on how and where to apply pressure to obtain a clean,
adequate drop of blood following the instructions in the tip sheet and the User’s
Guide.
i Instruct the trainees not to apply strong repetitive pressure i.e. not to milk the
finger. Point out that this may cause an inaccurate result.
Applying a Fingerstick Sample
Instruct the trainees on how to properly apply the large hanging drop to the sample well.
1. Apply the sample to the sample well on the strip over the green light.
i Stress the importance of applying the sample immediately after performing the
fingerstick. Point out that the PT test result is based on timing and that the blood starts
to clot as soon as it is exposed to the air. Any delay in applying the sample will lead to
an inaccurate result.
i Instruct the trainees that not hitting the target will result in the sample smearing
on top of the strip which will lead to insufficient sample in the well.
i Stress that it is very important not to move the meter after the sample has been
applied. Point out that doing so may give an inaccurate result.
2. When the meter beeps and displays the Testing Sample screen, the test has begun.
i Stress the importance of applying sufficient blood in order to get an accurate
result. A good way to check this is to look at the sample well after the test has started
to see if there is some blood left in the sample well.
i Stress that it is very important not to apply a second drop of blood. Applying a
second drop of blood may lead to an inaccurate result. If there is not enough sample,
begin the test again with a new fingerstick and a new strip.
3. When the meter beeps again the test is complete and the result is displayed in the
units chosen in the setup.
4. Remove the strip. Discard the strip and lancet in a biohazard, puncture proof
container.
5. Record the result as appropriate (depending on your institution’s policy)
12
N Show the trainees where to find these steps in the User’s Guide in the section
“Collecting a Fingerstick Sample” and “Performing a Test” and in the tip sheet “Tips for
Obtaining a Good Fingerstick Sample”.
1. The amount of blood that should be applied to a test
strip is:
a) A large "hanging" drop of blood.
b) At least 15 µL of blood.
c) Enough blood to cover the sample well.
d) All of the above.
2. If the drop of blood is not big enough you can just add
more blood. True or False?
Applying a Sample using a Micro-capillary Tube
Instruct the trainees on the use of micro-capillary tubes for applying a fingerstick sample
to the strip. Some sites may not have Micro-capillary tubes at the time of phone training.
In this case walk through the Package Insert.
Point out that this techniques should be used in situations where the sample cannot be
applied directly to the application site e.g. bed ridden patient or patient with dexterity
problems.
i Stress the importance of not squeezing the bulb on the Micro-capillary Tube while
collecting the sample. This can lead to bubbles in the sample which may lead to an
inaccurate result.
i Stress again that it is very important not to move the meter after the sample has been
applied. Point out that doing so may give an inaccurate result.
N Show the trainees where to find this information in the Micro-capillary Package
Insert.
i Important Points to Emphasize and Repeat
? The importance of good fingerstick technique
? Never move the meter once the strip is inserted
? Enter the correct calibration code
13
Chapter 5 – Troubleshooting
Troubleshooting
Walk through this section with the trainees making sure to cover all the Error Messages,
Abnormal Results and Limitations of the System
Error Messages
Walk the trainees through the Troubleshooting section of the User’s Guide. Hand out the
sheet “Error Message Troubleshooting Guide”. Explain each Error Screen and describe,
using examples what action should be taken.
N Show the trainees where to find the “Error Screen” descriptions and the suggested
“Action to Take” in the Troubleshooting section of the User’s Guide (pages 46 to 49) and
on the Error Code Summary in this training binder.
If a message "Error QC 2L", indicating that the on-board
controls are out of range, appears on the display:
a) Call HemoSense Technical Support
immediately.
b) Rerun the test. If you get a result the second
time, the system is working properly.
c) Discard the rest of the box of test strips.
Abnormal Results
Walk the trainees through the Results section of the Test Strip Package Insert.
Explain what the normal and therapeutic ranges are and what to do in the event of an
unusual result.
Point out that the HemoSense recommendation is to repeat the test if a value is unusually
low or high. If the result still does not match the clinical situation, test by another method.
i Stress the importance of responding appropriately to an unusually high or low result.
Instruct the trainees to familiarize themselves with their site policy on confirmed high and
low results and act accordingly.
Limitations of the System
Walk the trainees through the Operational Precautions and Limitations section of the
User’s Guide and the Limitations section of the Test Strip Package Insert.
Be sure to cover all of the following:
1. Use only fresh capillary whole blood. No plasma or anticoagulated whole blood.
No blood from a venous draw.
2. Minimum 15uL of blood required.
3. The system is sensitive to heparin and low molecular weight heparin.
4. Do not use outside of 30 to 55% hematocrit.
14
N Show the trainees where to find this information in the Test Strip Package Insert and
in the User’s Guide page 41.
1. The INRatio system can be used with:
a) Capillary whole blood.
b) Venous whole blood.
c) Plasma.
d) All of the above.
Warranty
Inform the trainees that the warranty period is one year from the date of purchase.
N Show the trainees where to find this information in the User’s Guide page 50.
i Important Points to Emphasize and Repeat
? Be aware of policies and procedures for an abnormally high or low result
? Be aware of the importance of the limitations of the system
Troubleshooting Tip Sheets Provided by HemoSense in this Section
1. Keys to Getting a Good Fingerstick and Capillary Blood Sample
2. Error Message Troubleshooting Guide
3. Printer Troubleshooting Guide
15
Chapter 6 – Finishing the Training
Review
The purpose of the review is to reinforce and repeat points or steps in the operation of the
system that are key to obtaining an accurate result and to interpreting that result
correctly.
Review these key points and answer any remaining questions:
1.
2.
3.
4.
Fingerstick technique
Storage of supplies
Changing the calibration code
Product limitations
Competency Quiz
The competency quiz determines whether trainees have understood the key concepts.
Use this exercise to determine if there are any remaining areas of confusion.
Training Certification
Fill out the Training Certificate, sign and give to the participants.
Retain a copy for your own records.
16
Chapter 7 – Forms
Forms Provided by HemoSense
Competency Quiz
Competency Quiz Answer Key
Training Certificate
Example Log Sheet
17
Chapter 8 – Your Site Specific Information
Feel free to insert your own site documents here.
18
Printer Trouble Shooting Guide
Problem:
Solution:
Green light is flashing
Printer is out of labels. Install a new roll of labels.
If labels are installed, look for jammed or damaged labels, and reload the labels.
The green light can also flash if the wrong labels are used.
Problem:
Solution:
Label jam
Open the cover. Cut the label roll between the back feed slot and the roll.
Push the form feed button to advance the labels through the printer.
Cut the label strip through so there will be a flat edge on the end of the strip. Reload the labels again.
Problem:
Solution:
Printer will not print
Make sure the printer cable is properly connected.
Make sure the printer is turned on. The green light will be on.
Check the power connection at the wall and at the printer.
Plug the printer into another wall outlet.
Problem:
Solution:
Self Test to verify that the printer is printing properly
Load a roll of labels.
Make sure the power cord is connected.
Turn the printer off.
Hold the form feed button down and as you are holding it down, turn the printer on.
When the printer starts printing, release both buttons simultaneously.
The printer will print out a few lines and at the bottom of it, it will say "ready".
Problem:
Solution:
Paper label roll does not fit in the printer
The right hand plate on the spindle has a triangle on one side.
This side should be facing the paper roll. Snap the plate on tightly. If the plate is not in this position the
spindle will not fit in the slot properly.
Problem:
Solution:
Print quality is poor
Print head may be temporarily misaligned. Unload and reload the labels and try printing again.
Problem:
Solution:
Printer prints gibberish
Can happen if there is a power surge. Unplug and plug the printer again.
Problem:
Solution:
Printing is faint
This is a thermal printer which does not have any ink to change. Reload the labels, clean the rollers and
reload the labels after the rollers have been allowed to air dry.
Recommended Labels:
Dymo Labelwriter White Shipping Labels, 2-1/8" x 4", 220 labels per roll
Available at office supply stores. 2-1/4" x 4" or 2-5/16" x 4" will also work.
HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134 1-877-436-6444 toll free (408)719-1393 tel (408)719-1184 fax www.hemosense.com
© 2005 HemoSense, Inc. All rights reserved. PN 5500261 Rev A
INRatio PT/INR Monitoring System: Correlations with Plasma-based Laboratory
and Whole Blood-based Point-of-Care PT Measurement Systems
Introduction
Clinical Laboratory Standards Institute (CLSI), formerly
known as NCCLS, guidelines for specimen collection,
transportation, storage and processing to minimize the
affect of pre -analytical variables on the lab sample. A
minimu m of 20 samples is recommended.
The INRatio PT/INR Monitoring System was developed
for point-of-care (POC) testing, specifically to improve
patient management for healthcare providers by using a
simple finger-stick sampling of capillary whole blood and
providing an immediate result. To facilitate a smooth
transition to a new device such as the INRatio Monitor,
comparisons to the current measurement system are
sometimes performed. This paper provides examples of
completed correlations comparing the INRatio system to
plasma based lab systems and other POC whole blood
based devices.
Factors to Consider
As described in previous INRatio Technical Bulletins
[#101–105] there are many factors to consider when
comparing PT results between different systems, including
but not limited to, factors that affect warfarin metabolism,
factors that affect the PT test itself, such as sample type,
reagent source/sensitivity, and instrument measurement
principle (Table 1). It is important to note that, as
mentioned in Table 1, the INR calculation itself explains
reasons for some differences:
ISI
INR = (Patient PT/ MNPT)
Purpose
The following correlations are provided as examples only
of previous studies between INRatio and existing PT
systems. These comparisons reinforce the strong
correlation found between INRatio and other systems,
including POC (whole blood) and lab-based (plasma
samples), as well as to reference laboratories, and
demonstrate acceptable performance of INRatio.
(MNPT= Mean Normal PT, ISI=International Sensitivity Index)
The ISI is an exponent, so any error in the ISI can magnify
errors in the calculation (hence, a low ISI due to a highly
sensitive reagent will minimize errors). In addition, results
exceeding 5.0 INR generally have reduced trueness,
precision and linearity both in POC and lab based PT
testing and should be interpreted accordingly.1
Procedure
The evaluations were performed using the HemoSense
Evaluations Guidelines, which recommend adherence to
Table 1: Factors that affect PT/INR results when comparing different systems.
Factors that affect
warfarin mechanism
or metabolism
• Illness (e.g.
congestive heart
failure, hyper- &
hypo-thyroidism,
hepatic failure)
• Drugs
• Diet (foods
containing vitamin K
and alcohol)
Factors that affect the PT test itself can
cause differences when comparing
systems
• Lack of comparability of INR between
reagents when used at onset of warfarin
therapy
• Loss of accuracy and precision when using
reagents with high ISI (low sensitivity
thromboplastin)
• Inherent variability with different
instrumentation
• Lack of reliability of ISI provided by
manufacturer
• Incorrect calculation of INR from use of
inappropriate control plasmas used to
determine the Mean Normal PT (MNPT)
Factors when comparing
capillary whole blood labbased plasma system
• Pretest variables
(especially for plasma
samples)
• Contaminated line
(Heparin)
• Antiphosp holipid
antibodies
• Hematocrit
Incorrect ISI of
thromboplastin
• Incorrect calibration
• Change in ISI over
time
• Poor distribution of
warfarin samples
• Incorrect choice of
reference
INRatio Monitor Characteristics
The INRatio Monitor determines the PT by measuring the
change in impedance of the sample as clotting occurs.
INRatio test strips use a recombinant thromboplastin
reagent with a low ISI, as re-commended by ACCP, CAP
and WHO.2 Each lot of INRatio Test Strips is calibrated to
a plasma based lab system traceable to the WHO standard.
Lot to lot variability is adjusted for by entering a test strip
calibration code with each new strip lot. In the
comparisons provided here, detailed reagent information
(source and ISI value of comparative reagent) was not
provided by the site.
1
Data Interpretation
In general terms, the “r” value may be interpreted as a
measure of scatter in the data. A factor influencing the
“r” value is the method of clot detection employed by
the system. The closer the “r” value is to 1.0 the better
the agreement between the individual points. Comparing
systems with different clot detection methods may give
rise to higher levels of scatter even when comparing lab
systems (see fig. 9).
The slope of the regression line may be interpreted as a
reflection of a systematic bias between the systems. A
factor influencing the slope is the calibration of the system.
All systems are calibrated differently, a fact reflected in the
slopes of the lab to lab comparisons (see fig. 7, 8 and 9).
The closer the slope is to 1.0, the less the bias between the
systems.
Comparisons between whole blood POC systems:
POC systems with the same sample type i.e. whole blood fingerstick show very good agreement even though the
measurement principals are quite different.
Fig. 1
Fig. 2
CoaguCheck vs. INRatio
ProTime vs. INRatio
y = 1.0141x + 0.0323, r = 0.94
y = 1.0441x - 0.0099, r = 0.94
5
7
6
4
INRatio
INRatio
5
3
4
3
2
2
1
1
0
0
0
1
2
3
4
0
5
1
2
3
4
5
6
7
ITC Protime
Coagucheck
Comparisons between whole blood POC and lab-based plasma systems:
Even with the differences in sample types added to the mix, the following comparisons between INRatio and several
laboratory-based plasma samples continue to show good correlations ranging from 0.93 to 0.99. Few (if any) clinical
discrepancies that would result in different dosing decisions are apparent. In each case the evaluating site implemented
the INRatio system due to acceptable agreement coupled with the additional features of the INRatio system.
Fig. 3
Fig. 4
AMAX vs. INRatio
MLA vs INRatio
y = 1.0457x + 0.1999, r = 0.96
6
y = 0.9759x - 0.0438, r = 0.976
5
5
4
INRatio
INRatio
4
3
3
2
2
1
1
0
0
1
2
3
4
5
0
6
0
Amax
1
2
3
MLA
2
4
5
Fig. 5
Fig. 6
Sysmex vs. INRatio
ACL vs. INRatio
y = 1.0809x + 0.104, r = 0.95
6
5
INRatio
5
4
INRatio
y = 0.9889x - 0.3382, r = 0.96
6
4
3
3
2
2
1
1
0
0
0
1
2
3
4
5
0
6
1
2
3
4
5
6
ACL 1000
Sysmex 1500
Commentary: Variability between laboratory analyzers is recognized and reported by others
To understand the variability among PT methodologies better, three comparisons are provided in Figures 7, 8 and 9
between lab systems commonly used: MLA, Sysmex, STA and AMAX. In addition, according to data provided by Dr.
Alan Jacobson, observed variation in INR can be high even between laboratory and reference laboratory analyzers (Fig
10). Plasma samples tested on 18 different instrument/reagent combinations demonstrated that as much as 2.5 INR
differences can be observed for a single sample run on multiple systems.
Fig. 7
Fig. 8
MLA vs Sysmex
MLA vs. STA
y = 0.8419x + 0.1663, r = 0.99
6
y = 0.7277x + 0.6668, r = 0.96
7
6
5
Sysmex 1500
5
STA
4
3
4
3
2
2
1
1
0
0
0
1
2
3
4
5
0
6
1
Fig. 9
4
5
6
Instrument/Reagent Combinations &
Observed Variation in INR
y = 0.7245x + 0.3779, r = 0.92
7
5.5
6
5
5
4.5
4
INR
AMAX
3
Fig. 10
MLA vs AMAX
3
4
3.5
2
3
1
2.5
0
0.00
2
MLA 1800 INR
MLA 1800 INR
2
1.00
2.00
3.00
4.00
5.00
6.00
7.00
1.5
MLA 1800 INR
Sample
3
7
Conclusions
Transitioning to a new coagulation measurement system
for PT is not difficult but has several points to consider
due to the many variables that exist across all PT/INR
testing modalities. In the context of this variability, the
correlations presented here show strong performance for
INRatio versus commonly used lab systems.
The frequently asked question “Will it match?” should
be carefully considered. However, in the end
consistency of test method is the key to the management
of patients on oral anticoagulant therapy. The INRatio
provides that consistency together with an easy to learn
and easy to use system.4
Measurement Principles of Comparison Systems
INRatio detects clot formation by a change in the
electrical impedance of the blood sample that occurs
when fibrinogen is converted to fibrin.
ProTime Microcoagulation System pumps the sample
back and forth until a clot forms. The clot is detected
optically as the motion of the blood decreases with clotting.
CoaguChek uses alternating magnetic fields in the
device which cause iron particles on the strip to move
within the sample; the endpoint is reached when the
blood clot stops the iron particles from moving.
Plasma based systems generally detect clot formation via
mechanical (AMAX) or optical means (ACL, MLA, STA,
Sysmex).
References
1
NCCLS Point of Care monitoring of anticoagulation therapy; approved guideline, NCCLS document H49-A Vol. 24 No. 23 (TSBN 1-56238540-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA, 19087-1898 USA, 2004.
2
The Seventh ACCP Conference on Anticoagulation Therapy: Evidence-Based Guidelines, Supplement to Chest, Volume 126, No. 3
(Supplement). September 2004: 2085-2095. ACCP: American College of Chest Physicians, CAP: College of American Pathologists, WHO:
World Health Organization.
3
Unpublished Abstract, Alan Jacobson, Loma Linda VA
4
Self management of oral anticoagulation with the INRatio system: impact of a structured teaching program on patient’s knowledge of medical
background and procedures; European Journal of Cardiovascular Prevention and Rehabilitation 2004, 11:000–000; Heinz Völler, Clemens
Dovifat, Johannes Glatz, Heinrich Körtke, Uwe Taborski and Karl Wegscheider.
Sysmex is manufactured by and a trademark of Sysmex Corporation. STA is manufactured by and a trademark of Diagnostica Stago Inc.
ACL is manufactured by and a trademark of Instrumentation Laboratory/Beckman Coulter Inc. AMAX is manufactured by and a trademark of
Trinity Biotech. MLA is manufactured by and a trademark of Medical Laboratory Automation, Inc. CoaguChek is manufactured by and a
trademark of Roche Diagnostics. ProTime is manufactured by and a trademark of ITC.
HemoSense, Inc.
651 River Oaks Parkway
San Jose, CA 95134 USA
1-877-436-6444 toll free
(408) 719-1393 tel
(408) 719-1184 fax
www.hemosense.com
©2005 HemoSense, Inc. All rights reserved. PN 5500285 Rev A
4
inratio professional
TrainingCertificate
Understanding the System
Meter description
Strip description
Meter operating conditions
Strip storage conditions
Safety
Main Menu
Performing a Test
Menu functions
Preparing to do a test
Performing a fingerstick
Applying a fingerstick sample
Applying a sample using a micro-capillary tube
Troubleshooting
Error messages
Abnormal results
Limitations of the system
Warranty
print name of trainer
signature of trainer
date
print name of trainee & employee id
signature of trainee
date
institution & location or unit
PN 5500265 REV A
Error Message Troubleshooting Guide
The INRatio meter can report abnormal operating conditions by displaying error or warning messages
appropriate to the condition on the meter display. The following provides a list of the error messages generated
by the INRatio meter with a description of the conditions which cause the message to be displayed. Some errors
allow the user to recover from the error condition whereas others are non-recoverable. In most cases the user
can recover from the error condition by repeating the test.
The following table describes both recoverable and non-recoverable error message. Recovery procedures are
described for each recoverable error.
Error Screen
•
What’s the problem?
What to do?
The sample was applied during
the warm up period before the
“Apply Sample” screen appeared.
•
•
A used strip was inserted.
•
Be sure to use a new strip for every
test.
•
Not enough blood reached the
test area. The possible causes for
this are:
o Not enough blood
applied to the sample
well.
o The strip channel is
blocked.
•
Begin the process again with a new
test strip and perform another
fingerstick.
Make sure to apply a large hanging
drop of blood. Consult the
Fingerstick Tip Sheet if you are
having problems obtaining a good
sample.
Do not try to add more blood from
the first fingerstick.
•
•
•
•
•
•
Only certain combinations of
numbers and letters are
recognized by the monitor. The
code entered was not recognized
by the monitor.
•
The monitor had a data
processing problem while
calculating the results from some
or all of the three channels. This
may be caused by the following:
o A problem with the
individual test.
o
Not enough blood was
applied to the sample
well.
•
The error appears as a three digit
number. Each digit represents
one of the channels on the strip
and may appear as 1, 2, 3, or 4.
Example: ERROR 411
•
•
•
•
Begin the process again with a new
test strip.
Be sure to wait until the “Apply
Sample” screen appears before
applying the sample.
Re-enter the correct code at the
“Strip Code” prompt.
If the message repeats, call
HemoSense Technical Support.
Begin the process again with a new
test strip and perform another
fingerstick.
Make sure to apply a large hanging
drop of blood. Consult the
Fingerstick Tip Sheet if you are
having problems obtaining a good
sample.
Do not try to add more blood from
the first fingerstick.
If the error message repeats, call
HemoSense Technical Support.
HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134 1-877-436-6444 toll free (408)719-1393 tel (408)719-1184 fax
www.hemosense.com
© 2005 HemoSense, Inc. All rights reserved. PN 5500264 Rev C
1
Error Screen
What’s the problem?
What to do?
•
An invalid date value was
entered.
•
Check the date and enter the correct
day, month and year.
•
The monitor was turned on with a
test strip in the strip holder.
•
If the strip was a used strip remove it
and insert a new strip when the
“Insert Strip” screen appears.
If the strip was a new strip, remove it
and reinsert it when the “Insert
Strip” screen appears.
Do not use a new strip that has been
out of the pouch for longer than 10
minutes.
If the message recurs, call
HemoSense Technical Support.
•
•
•
•
The test result is outside the
range of the monitor.
•
•
Repeat the test.
If the message repeats, contact your
physician.
•
An invalid target range has been
entered e.g. the lower end of the
target range entered is higher
than the upper range
•
Re-enter the correct upper and
lower values and continue with the
setup.
•
The temperature of the room is
less than 65oF (18oC) and the
monitor cannot heat up within
the allowed time.
•
Move the monitor to a warmer
location and wait until it has
warmed up before performing the
test.
•
The temperature of the room is
higher than 95 oF (35oC) and the
monitor cannot cool down.
•
Move the monitor to a cooler
location and wait until it has cooled
down before performing the test.
HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134 1-877-436-6444 toll free (408)719-1393 tel (408)719-1184 fax
www.hemosense.com
© 2005 HemoSense, Inc. All rights reserved. PN 5500264 Rev C
2
Error Screen
What’s the problem?
•
•
One or both of the on-board
controls are out of range due to
one of the following causes:
o The strip has been
exposed to excessive
hear or humidity.
o The user technique is
poor.
If the monitors units are set to INR
or INR+PT, the Error may look like
any of the following: QC 1H, QC
1L, QC 2H, QC 2L, QC 1+2
What to do?
•
•
•
•
•
•
No INR value is displayed because
one or both of the on-board
controls are out of range due to
one of the following reasons:
o The strip has been
exposed to excessive
hear or humidity.
o The user technique is
poor.
QC values are displayed because
the monitors units are set to
INR+PT+QC
•
•
•
•
•
•
The printer option has been
selected and one of the following
may have happened:
o There is no printer
connected to the meter.
o The printer is not
functioning properly.
There is no paper in the printer.
•
•
•
Repeat the test with a new test strip
and a fresh fingerstick paying careful
attention to proper technique.
If the message repeats, it may be an
indication that the strips have
deteriorated. Perform the following
checks before proceeding:
1) Is the strip outside the
expiration date on the
pouch?
2) Was the strip stored
outside the recommended
storage conditions e.g. in a
hot place?
3) Are the pouches of the
remaining unopened
strips damaged?
If any of these conditions occurred,
do not use the strips for further
testing.
Call HemoSense Technical Support if
the message repeats.
Repeat the test with a new test strip
and a fresh fingerstick paying careful
attention to proper technique.
If the message repeats, it may be an
indication that the strips have
deteriorated. Perform the following
checks before proceeding:
4) Is the strip outside the
expiration date on the
pouch?
5) Was the strip stored
outside the recommended
storage conditions e.g. in a
hot place?
6) Are the pouches of the
remaining unopened
strips damaged?
If any of these conditions occurred,
do not use the strips for further
testing.
Call HemoSense Technical Support if
the message repeats.
Recheck all the connections to make
sure the printer is connected.
If the error message repeats, call
HemoSense Technical Support.
Insert paper into the printer and try
to print again.
HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134 1-877-436-6444 toll free (408)719-1393 tel (408)719-1184 fax
www.hemosense.com
© 2005 HemoSense, Inc. All rights reserved. PN 5500264 Rev C
3
Error Screen
Error 01, Error 02, Error 03, Error 10,
Error 11, Error 12, Error 13, Error 14,
Error 15 and Error 20.
What’s the problem?
The batteries are running low.
•
•
Continue with the present test.
Replace the battery as soon as
possible.
•
The batteries are dead and the
meter will not operate.
•
•
Replace the batteries or
Plug the unit into a wall outlet.
•
If you see any of these errors it
means there is a problem with the
monitor
These errors cause the meter to
shut down:
o If the OK button is
pressed
o If the message has been
displayed for 60 sec.
An error has been detected
during the monitor self test
process which causes the green
light in the application area to
flash
•
If a non-recoverable error is
displayed, make note of the error
number and contact HemoSense
Technical Support.
•
If a non-recoverable error is
displayed, make note of the error
number and contact HemoSense
Technical Support.
•
These errors are non-recoverable
Flashing green light in
the application area
This is a non-recoverable error
What to do?
•
•
HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134 1-877-436-6444 toll free (408)719-1393 tel (408)719-1184 fax
www.hemosense.com
© 2005 HemoSense, Inc. All rights reserved. PN 5500264 Rev C
4
INRatio Example Log Sheet
Test Results Log • Quality Control Check • Daily Cleaning/Maintenance Log
Instrument Serial #________________
Patient/Resident
Strip Lot #_______________________
Test Results
PT
INR
QC OK?
Yes
No
Strip Code______________________
Date/Time By
QC Results
QC1
QC2
Daily Cleaning/Maintenance Log (To document cleaning, place initials in box under date)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134 1-877-436-6444 toll free (408)719-1393 tel (408)719-1184 fax
www.hemosense.com © 2005 HemoSense, Inc. All rights reserved. PN 5500263 Rev A
31
INRatio Competency Quiz Answer Key
1. (d)
2. False
3. Three
4. Two
5. (a)
6. 10 min
7. (d)
8. (c)
9. (b)
10. (d)
11. False
12. (b)
13. (a)
HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134 1-877-436-6444 toll free (408)719-1393 tel (408)719-1184 fax www.hemosense.com
© 2005 HemoSense, Inc. All rights reserved. PN 5500262 Rev B
INRatio Competency Quiz
1. The menu button:
a. May be used to turn on the meter.
b. Accesses the meter menu.
c. Accesses the memory functions of the meter.
d. All of the above
2. To run a test you can hold the meter in your hand while applying the sample as long as you set it down within 10 seconds. True or False?
3. How many channels are on the test strip? _________
4. How many controls are on the test strip? __________
5. How long can test strips be stored:
a. Until the expiration date on the box.
b. For six months.
c. For three months or until the expiration date on the box, whichever comes first.
d. Indefinitely.
6. How long can the strip be out of the pouch before performing a test? __________
7. To turn off the INRatio meter:
a. Wait 10 minutes, and it will turn off by itself.
b. Press the menu key, scroll down to "turn meter off" and press the OK button.
c. Since there is no on/off button, it must be unplugged.
d. Both a) and b).
8. If the strip code displayed on the meter DOES NOT match the strip code number (the code in bold print on the outside of the strip
pouch), you should:
a. Discard that strip and find one that matches.
b. Use the strip anyway.
c. Correct the code on the meter display by using the "up/down" arrow key.
d. Call HemoSense Technical Support
9. If the test strip is inserted upside down:
a. It will break the meter.
b. The meter will not recognize that a strip has been inserted.
c. The meter will run a test anyway, and the results will be correct.
d. The meter will run a test anyway, but the results may be erroneous
10. The amount of blood that should be applied to a test strip is:
a. A large "hanging" drop of blood.
b. At least 15 µL of blood.
c. Enough blood to cover the sample well.
d. All of the above
11. If the drop of blood is not big enough you can just add more blood. True or False?
12. If a message "Error QC 2L", indicating that the on-board controls are out of range, appears on the display:
a. Call HemoSense Technical Support immediately.
b. Rerun the test. If you get a result the second time, the system is working properly.
c. Discard the rest of the box of test strips.
13. The INRatio system can be used with:
a. Capillary whole blood.
b. Venous whole blood.
c. Plasma.
d. All of the above.
HemoSense, Inc. 651 River Oaks Parkway, San Jose, CA 95134 1-877-436-6444 toll free (408)719-1393 tel (408)719-1184 fax www.hemosense.com
© 2005 HemoSense, Inc. All rights reserved. PN 5500262 Rev B
Prothrombin Time/INR Measurement in the Physician’s Office:
Improved Quality of Care
Steven Cohen MD, Cobb Medical Group, Austell GA 30106
In today’s health care environment, both insurance
companies and Medicare are monitoring physician
performance. The cost of providing care, the
degree to which a physician’s patients achieve
certain measured outcomes (HbA1c levels in
diabetics, percentage of patients with coronary
artery disease on beta blockers, the frequency of
mammograms and PAP smears in women, etc.)
and the level of patient satisfaction with a
physician’s treatment are tracked. In some areas,1
insurance companies and employers provide
bonuses to physicians who meet defined
benchmarks (e.g., number of patients with
Hemoglobin A1c under 7.0, etc.). In an ongoing
pilot project, Medicare pays physicians and
hospitals bonuses if certain quality benchmarks are
met.2 Physicians today have to meet the challenge
of helping patients achieve a defined outcome in a
cost-effective fashion. At the same time, the
combination of increasing overhead and flat or
decreasing reimbursement from payors means that
physicians cannot simply hire more employees to
achieve these outcomes. It is necessary to “work
smarter,” not just “work harder,” to maintain a
thriving practice in today’s healthcare
environment.
The medical literature has demonstrated that
point of care testing (defined as performing a test
while the patient is present, as opposed to sending
the test to a reference lab and receiving the test
results at a later time) is helpful in treating
conditions as varied as bacterial vaginosis,3
diabetes,4 respiratory syncitial virus,5 and
anticoagulant therapy.6 The ability to perform a
PT/INR in-house and obtain results at the time of
a patient’s visit can help physicians increase patient
satisfaction while maintaining the same level of
clinical outcome (defined as the percentage of time
that a PT/INR is within the therapeutic range).7
In the United States an estimated 250,000 people
are hospitalized annually with thromboembolic
events8 and 2.2 million people are affected by atrial
fibrillation.9 The incidence of complications in
patients treated with warfarin ranges from 0.22.2/100 patient-years.10 This emphasizes the
importance of monitoring the PT/INR and
keeping it within the therapeutic range, to
minimize both the risk of complications from the
underlying condition and bleeding complications
from warfarin.
The Hemosense INRatio® system is a CLIA
waived test that can be performed by the nursing
staff to provide PT/INR results before the patient
leaves the clinic. Combining a nurse visit with the
testing gives the staff an opportunity to check
medication compliance, monitor for the presence
of complications, provide ongoing patient
education on the proper use of warfarin and
monitor the use of medications or herbal
treatments which can interact with warfarin11 (see
Appendix 1).
One valuable aspect of point of care testing is the
elimination of “phone tag” in this age of voice mail
and answering machines. If the specimen is sent to
the laboratory, the cost of notifying the patient of
the results by phone can be estimated at $4.25/test
based on the following assumptions:
1. Staff salary of $14/hour with an additional
25% cost of benefits, for a total hourly rate of
$17.50.
2. Two calls made by clinical staff before
contacting a patient with the results (5
minutes/call to pull the chart, call the patient,
leave a message or explain the results and to
refile the chart).
1
3. Five minutes of staff time for the operator to
answer the call from the patient requesting the
results, take a message, and attach it to the chart
for the clinical staff to respond to the phone call.
Providing the results to the patient at the time of
testing would eliminate all but 3 minutes of the time
above (estimated time for nurse to explain results to
patient) for a savings of $3.40/test. This translates
into an annual savings of $2448 for a physician who
performs 3 tests/day. Additionally, the patient has a
better chance of understanding and properly
following physician instructions.
A nurse or medical assistant may use a structured
questionnaire (see Appendix 1) to help monitor the
use of warfarin. This can fulfill the criteria for a
99211 visit, which are as follows:12
1. The E/M service must be provided face to face.
2. The patient must be an established patient in
the practice.
3. The visit must be medically necessary.
4. The physician must have previously seen the
patient so that the services of the staff are
incident to the treatment plan established by the
physician. The physician does not have to be in
the same room where the patient is being seen,
but must be in the suite. The documentation
should clearly indicate that the physician is
periodically participating in the care of the
patient.
5. The documentation must identify the date of
service as well as the identity of the staff
providing the care.
The American College of Physicians July/August
2000 newsletter reports that ICD-9 code v58.61,
long-term (current) use of anticoagulants should be
the primary code used for ordering the prothrombin
time. The diagnosis that prompted the use of
warfarin (e.g., atrial fibrillation 427.31, pulmonary
embolism and infarction 415.10) can be used as the
secondary diagnosis.13
An example of a structured questionnaire that may
be administered by the nurse is listed in Appendix 1.
Appendix 2 contains an example of a flow sheet for
continuing warfarin treatment.
2
References
1
Colwell J. Pay-for-performance takes off in California. ACP
Observer, Jan-Feb 2005.
http://www.acponline.org/journals/news/jan05/pfp.htm.
2 CMS Office of Public Affairs, Fact Release, Jan 31, 2005.
http://www.cms.hhs.gov/media/press/release.asp?Counte
r=1343.
3 West B, et al. Evaluation of a new rapid diagnostic kit
(FemExam) for bacterial vaginosis in patients with vaginal
discharge syndrome in The Gambia. Sex Transm Dis. 2003
Jun;30(6):483-9.
4 Feinberg WM, Blackshear J, Laupacis A, Hart RG.
Prevalence, age distribution, and gender of patients with
atrial fibrillation: analysis and implications. Arch Intern
Med 1995;155:469-73.
5 Mackie PL, McCormick EM, Williams C. Evaluation of Binax
NOW RSV as an acute point-of-care screening test in a
paedriatric accident and emergency unit. Commun Dis
Public Health 2004 Dec;7;328-30.
6 Caffee AE, Teichman PG. Improving anticoagulation
management at the point of care. Fam Pract Manag 2002
Feb;9:35-37.
7 Shiach CR, et al. Reliability of point-of-care Prothrombin
time testing in a community clinic: a randomized
crossover comparison with hospital laboratory testing. Br J
Haematol 2002 Nov;119:370-75.
8 Goldhaber SZ. Pulmonary embolism. N Engl J Med 1998
Jul;339:93-104.
9 Maisel WH. Atrial fibrillation in heart failure: epidemiology,
pathophysiology, and rationale for treatment. Am J
Cardiol. 2003 Mar 20;91(6A):2D-8D.
10 Braunwald, E. Heart Disease: A Textbook of Cardiovascular
Medicine, 6th ed, p 1699-1700, 2001.
11 Price CP. Medical and economic outcomes of point-ofcare testing. Clin Chem Lab Med 2002 Mar;40: 246-51.
12 Audit and Reimbursement Department, University of
Missouri Health Care, July 2002 Newsletter.
http://www.muhealth.org/~UPReimbursement/julynews0
2.htm
13 Baker B. ACP-ASIM Observer, July 2000.
http://www.acponline.org/journals/news/julaug00/billingguides.htm
APPENDIX 1
Patient name______________________________________ DOB________________ Date of Visit_____________
PT/INR Assessment - CLARIFY ANY YES ANSWERS
YES
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
NO
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
____
Change in meds since last visit
Recent antibiotic use?
Use of OTC pain relievers? Nsaids, aspirin, tylenol?
Use of OTC meds for stomach, Zantac, Tagamet, antacids etc?
Vitamin use?
Change in intake of green herbal teas or green leafy vegetables?
Change in alcohol intake (beer, wine, liquor)?
Alcohol intake in last 48 hours?
Any recent illness?
Any herbal medications? Specify which ones. (May circle herbs below)
Recently stopped any herbal therapy?
Any extra doses of warfarin since last visit?
Any missed doses of warfarin?
Travel plans?
Planned dental visit in near future?
Planned surgery in near future?
Prescription for warfarin needed?
Any bleeding?
Any bruising?
Chest pain/leg pain or swelling/dyspnea/headache?
Hospitalization since last visit?
Herbs reported to affect anticoagulation (grouped by mechanism)
Anticoagulants:
Coumarin constituents: Alfalfa, Angelica, Aniseed, Arnica, Asafetida, Boldo, Capsicum, Celery,
Chamomile(german), Chamomile (roman), Dandelion, Fenugreek, Focus, Horse-Chestnut,
Nettle, Passionflower, Prickly Ash (northern or southern), Quassia, Red Clover
Inhibition of platelet aggregation or activity: Bilberry, Clove, Cat’s Claw, Feverfew, Ginger,
Gingko, Liquorice
Salicylate constituents: Meadowsweet, Poplar, Willow
Peroxidase stimulates synthesis of arachidonic acid metabolites: Horseradish
Procoagulants:
Coagulant: Agrimony
Heparin antagonist: Golden Seal
Lectin agglutinating activity: Mistletoe
Coagulant in vivo: Yarrow
Barnes, J. et. Al. Herbal Medicines: A guide for healthcare professionals.
Pharmaceutical Press, London, 2nd edition, 2002.
Staff Signature______________________________________
3
APPENDIX 2
ANTICOAGULATION FLOW SHEET
Patient name______________________________________ DOB________________ MR#_____________
Diagnosis for anticoagulation________________________ ICDM code_____________
Date warfarin began_______________ Date to finish_______________ / permanent
INR Goal_____________________
Date
PT
INR
Warfarin Dose Dose Change
Next PT
______________
_______
_______
____________ ____________
___________
_____________________________
______________
_______
_______
____________ ____________
___________
_____________________________
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____________ ____________
___________
_____________________________
______________
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_______
____________ ____________
___________
_____________________________
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____________ ____________
___________
_____________________________
______________
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____________ ____________
___________
_____________________________
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_______
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____________ ____________
___________
_____________________________
_____________
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____________ ____________
___________
_____________________________
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____________ ____________
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_____________________________
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____________ ____________
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_____________________________
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____________ ____________
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_____________________________
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____________ ____________
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_____________________________
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____________ ____________
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_____________________________
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____________ ____________
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_____________________________
______________
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_______
____________ ____________
___________
_____________________________
______________
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_______
____________ ____________
___________
_____________________________
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