point of care (poc) blood glucose monitoring

Point of Care (POC) Blood Glucose Monitoring

1

Accu-Chek Inform II Operator Training

Presentation Objectives

• User certification

• Meter interferences

• Patient testing exclusion criteria

• Introduction to the Accu-Chek Inform II meter

• How to run QC

• Meter maintenance

• Patient testing

• Critical Values

• Results review

2

Certification

• Certification of all personnel and yearly recertification (demonstrating on-going competency)

• Lab accreditation requirement

• treatment decisions are made based on these results

• Professional responsibility

3

Dr. M.E.Lyon

Glucose Meter

User Error

Exogenous

Interferences

Endogenous

Interferences

Environmental

Factors

ie. hand washing,

expired strips

ie. Hematocrit, renal

failure

ie. Altitude, temperature,

humidity

ie. Galactose,

ascorbate, tylenol

Factors Affecting Glucose Meter Performance

Boston Biomedical Consultants, 2010

Glucose Meter

User Error

Exogenous

Interferences

Endogenous

Interferences

Environmental

Factors

ie. hand washing,

expired strips

ie. Hematocrit, renal

failure

ie. Altitude, temperature,

humidity

4

The Enigma of Glucose Measurement

Glucose meter:

2.3 mmol/L

Blood Gas Analyzer:

2.9 mmol/L

Clinical Lab (plasma hexokinase):

1.5 mmol/L

Which one is right?

5 Dr. M. E. Lyon

Patient Specific Factors That Could Influence Glucose Meter Performance

The Patient

Medications/Treatments

Clinical Laboratory Parameters

Hematocrit?

Plasma Water Concentration?

RBC Water Concentration?

Ascorbate?

Peritoneal Dialysis?

Infant formula? Galactose

Patient Characteristics

Metabolic?

Ambulatory?

Intensive Care?

Burn Patient?

Renal Disease?

6 Dr. M. E. Lyon

Accu-Chek Inform II Operator Training 7

Highlights of the Inform II System

Sample size – 0.6 microliters and applied to FRONT EDGE TIP of strip

Testing time – 5 seconds

Linear range for meter is 0.6mmol/L-33.3mmol/L

Use of second blood drop for testing

Cleaning site with soap and water

Strip must be in meter BEFORE testing.


Operator ID lockout – Will need to enter Operator ID to test

Operator ID will be given to certified users only

Your operator ID will be tied to the result for which you are then accountable

Meter must be docked for recharging-and remain in Base Unit when not in use.

More Highlights of the Inform II System

8


Accu-Chek Inform II Introduction

Tote Box -NOT for

storage of meter only

storage of strips, controls,

lancets, ref guide

Accu-Chek Inform II

(wireless available)

Base Unit for automatic data

transfer and charging battery

Blue light on when

communicating, green when

charging

Red is when you first plug in

Base Unit to power outlet until

meter gets put in it



Barcode Scanner (Laser)

Test Strip Port

Touchscreen-

Main menu

with 3 options

On/Off Button


Back of Meter

• Meter re-set button

(for meter freeze situation, only to be accessed upon

recommendation of key operator or vendor)

•Re-Chargeable Battery Pack

•Charging Contacts

(To Base Unit)

•Infra-red contact to upload lot information only to be accessed

by key operator or vendor

11


Accu-Chek Inform II Test Strips – 50/vial

(replace cap immediately!)

Strips are good until manufacturer expiry

date. Replace lid when strips are not in use.

Accu-Chek Performa Control Solutions

Control 1 and Control 2

Good for 3 months at Room Temp after

opening - write open date on vial.



When To Run QC

13

QC is to be run:

1)Every 24 hours

2)If the meter is dropped or potentially damaged

3)If you suspect that the result is incorrect

4)If a new lot # strips or QC


Cleaning the Meter and Accessories

• Remove the meter from the docking station • Always clean meter between patient use • Wipe with Percept RTU wipe that has been wrung out so it is not

too damp.

• If visibly soiled-wipe to remove soil-wipe again for disinfection

• Gently wipe exposed areas, carefully avoiding the connectors

and openings on meter and docking station.

• meter has only one opening – strip port entry

• Always allow the meter and base unit to thoroughly air dry

before putting it back into use.

• Refer to cleaning procedure for more in depth cleaning

instruction

14


Cleaning Meter after testing when Patient is on Precautions:

1. Leave the meter in the room on a flat surface near the door

2. Remove PPE in the usual manner

3. Do Hand hygiene

4. Donn clean gloves and take an approved pre-moistened disinfectant wipe

5. Go back into room, get meter and wipe it down

6. Take the clean meter out of the room and place it on a clean surface

7. Remove gloves and do Hand Hygiene

8. Place meter into the base

15


Hands On with meter!

Remove meter from base unit.

1. Press and release the On/Off button

2. ‘Power Up’ screen appears after meter performs self-

checks

3. Note battery life symbol in bottom right corner will

be fully black if fully charged

4. Manually proceed to the next screen by touching

symbol (happens automatically after 5 seconds)


Entering an Operator ID - Manual Entry – Hands On

• Touch the symbol to backspace and delete a

character entered incorrectly

• Touch symbol to confirm

Once entry is complete, the main menu appears

Picture

with

operator

ID

screen-

not QC


Entering an Operator ID – Barcode Scanner Hands On

Operator ID may be scanned from the barcode reader:

1. Touch and release the ‘Scan’ symbol in top right corner of

screen (black background=scan mode)

2. Hold meter so window of scanner is 4-8 inches above

barcode you wish to read.

Meter beeps once the barcode has been read successfully

and info scanned appears on screen. Scanner turns off

after 5 seconds.


Accu-Chek Inform II Perform Quality Control (QC) Hands On – Run 1 level QC

QC testing is required every 24 hours and if

not done, meter will be locked out until

QC testing is completed

1. Touch Control Test

2. Press barcode icon and scan the barcode on a

Quality Control Vial.

3. Choose or scan lot number of strips you will be

using

4. Press √ to continue

Both level 1 and 2 must be run every 24

hours

• NOTE: lot numbers cannot be manually entered


Accu-Chek Inform II Perform a QC – Hands On

4. When “Flashing Arrow” symbol appears, insert test strip into test strip port at top of

meter. “Flashing Drop” symbol appears when meter is ready for QC sample

5. Mix the control vials by gently inverting 5 times

6. Remove cap and wipe vial with tissue

7. Discard first drop and apply 2nd drop to FRONT EDGE TIP of strip (not Top)

Result will appear within 5 seconds

Note: Test strip must ALWAYS be in meter BEFORE application of Quality Control

sample!!


Accu-Chek Inform II Perform a QC – Hands On

1. Quality Control result will display as PASS or FAIL

2. If you see quality control has PASS then chose √ and move on the barcode scan of the other level of quality control

3. If the quality control FAILS the comment icon in the lower left of the screen will flash. Press on it and chose the appropriate comment from the drop down list and then press √ to confirm. Confirm once again on the FAIL screen and then repeat control. Once both QC levels have PASSED you can proceed with patient testing.

Comment is required if result is “Out Of Range” or an error.

Touch symbol in lower left corner of screen, pre-programmed comments will appear. (Up to 3 comments can be selected)

Touch in lower right to confirm selection.

Note: Once exited from QC result/comment screen, new comment cannot be added later.

21


Accu-Chek Inform II Perform a Patient Test – Hands On

1. Touch ‘Patient Test’.

2. Confirm selection by touching in

lower right corner of screen.


Accu-Chek Inform II Perform a Patient Test- Hands On

confirm the test strip lot:

3. Touch barcode symbol top right corner of screen

4. Scan barcode on strip vial holding scanner 4-8 inches in front of

vial barcode

5. When “Flashing Arrow” symbol appears, insert test strip (close cap

asap)

Note: Test strip must ALWAYS

be in meter BEFORE

application of patient blood

sample!!


Accu-Chek Inform II Perform a Patient Test – Hands On – Simulate with Level 2 Control

6. For actual patient testing - make sure site is cleaned with soap

and water and thoroughly air dried

*Scan the patient’s barcode or manually enter the patient PHN or

MRN*

7. When “Flashing Drop” symbol appears, pierce site

8. Wipe away first drop and apply second drop to front edge tip of

test strip (not top). You have up to 5 minutes to apply the sample.

(note: Can re-dose within 5 seconds, if needed)

Result appears after 5 seconds


Accu-Chek Inform II Entering comment for Critical Result – Hands On

Required if result is a “Critical Value” or an error

10. Touch comment symbol in lower left corner of the screen

11. Touch up to three pre-programmed comments. A comment is required for all critical value results

12. Touch in lower right to confirm selection.

13. To confirm, touch again if satisfied with comment and to exit from screen.

Note: Once exited from result comment screen, new comment cannot be added later.

*If no comment was required, press in lower right corner of result screen.

25


Neonatal Heel Puncture Provide comfort measures (swaddling, suckling, sucrose)

Choose site avoiding calcaneum and plantar surfaces Squeezing heel increases pain and cell lysis and decreases blood yield Contraindications include edema, injuries or anomalies, poor perfusion, or infection. These could lead to erroneous results.


Accu-Chek Inform II Results Review Patient or Quality Control – Hands On

From main menu screen touch ‘Review Results’. Stored test results are

displayed in a sequential list.

Touch or to scroll up or down in the list. Results are grouped by date.


Accu-Chek Inform II Results Review- Hands On

•Touch an entry in list to display related details.

• When the details are displayed touching the ‘Patient’ symbol to display all results

remaining in the meter for that specific patient only.


a) Observed testing/certification is needed

Software Overview and Features OTS (1/2)*

Roche Diagnostics, ACI II Softw are Overview and Features 6_8.ppt March-2017

b) Operator performs a test under observation:

* Example screenshots, not necessarily an exact match when instrument is connected to cobas IT 1000


Software Overview and Features OTS (2/2)* in mg/dl

c) Observer rates and comments the observed test execution:

Roche Diagnostics, ACI II Softw are Overview and Features 6_8.ppt March-2017

* Example screenshots, not necessarily an exact match when instrument is connected to cobas IT 1000


Accu-Chek Inform II Ranges

Action Values:

Result on meter less than 4.0 mmol/L follow hypoglycemia protocol.

Results greater than 22.0 mmol/L follow protocol & call MD

Critical Action Values:

Less than 2.8 mmol/L follow hypoglycemia protocol

Linearity Range of Meter 0.6 – 33.3 mmol/L

Hematocrit operating range: 23%-58% for neonates, and 10%-65% for adults

Sample Types- results may vary depending on the source of the blood sample

Venous

Arterial

Capillary

point of care (poc) blood glucose monitoring

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