Accu-Chek® Performa and Accu-Chek® Inform II Blood Glucose Meter Training 28 November 2018 page 1 © 2009 Roche

Why Training? Medicines & Healthcare products Regulatory Agency Nursing & Midwifery Council Hospital Trust RCN Department of Health: “The use of blood glucose meters by untrained staff, without adequate management supervision of the equipment and without the use of quality control procedures, can lead to misleading results, adversely affecting the treatment of patients” MHRA 1996 28 November 2018 page 2 © 2009 Roche

Refer to strip pack insert for limitations for use Contra-indications For Use Of Blood Glucose Meters As indicated by the M.H.R.A If peripheral circulation is impaired collection of capillary blood is not advised as there is a risk that the result obtained may be unreliable. Preferably a venous sample should be sent to the lab, however it is also possible to measure glucose POCT on a venous sample. Examples of condition where peripheral circulation may be impaired include; Severe Dehydration due to Diabetic Ketoacidosis Hypotension Shock Hyperosmolar, Hyper glycaemic State (known previously as H.O.N.K ) Decompensated heart failure NHYA Class IV Refer to strip pack insert for limitations for use We acknowledge that staff are required to perform POCT capillary blood glucose determination as part of national protocol in some of the conditions listed above. In these circumstances we recommend caution in the interpretation of results obtained from capillary blood glucose instruments. Result should be reviewed in the knowledge that capillary results have the potential to be misleading in the conditions listed above. 28 November 2018 page 3 © 2009 Roche

Accu-Chek Performa Meter On/Off button Display Screen QC Buttons On/Off Button – Press and hold down to display screen contents. Check that screen is full of icons and the segments that form the “8”s are intact. Ensure all areas of the screen are clearly visible. Screen should be checked each time meter is switched on , minimum daily. (meter may have been dropped and the screen may have been damaged / not display figures clearly e.g may display a 3 but should be an 8 – this could have implications to the treatment given) Memory Buttons – Do not use memory function in clinical setting as not able to input patient identification into meter. This should NEVER be used in a professional setting. Storage – The meter and all associated consumables should be stored at room temperature. Avoid extremes of heat/cold. Replacement Meter – Ask staff where a new meter should be obtained. Test Strip Slot 28 November 2018 page 4 © 2009 Roche

CR2032 battery – Only order from Lab! Insertion of Battery CR2032 battery – Only order from Lab! Inserting a battery: Push the recessed plastic tab of the battery compartment forward (towards the arrow) to flip open the battery door. Insert the battery into the compartment with “+” side facing you. Snap battery cover into place. When a battery symbol appears on the screen or error code E-9 appears on the screen, change the battery immediately. The performa meter has a back up battery inside the meter which maintains the time & date. This enables the meter to determine the code chip expiration date, preventing the use of expired test strips. Give staff opportunity to change the battery if necessary. New battery obtained from? 28 November 2018 page 5 © 2009 Roche

How to Calibrate the Performa Meter 28 November 2018 page 6 © 2009 Roche

Accu-Chek Inform II Test Strip Golden End (electrodes) Yellow Window 28 November 2018 page 7 © 2009 Roche

Patient Testing Consent Infection Control Patient preparation Obtaining a sample 28 November 2018 page 8 © 2009 Roche

Patient test - Application of Blood to Strip Explain this is how you apply the blood to the test strip. All results must be documented in accordance with Trust policy. 28 November 2018 page 9 © 2009 Roche

Quality Control Testing Why Quality Control? How often is Quality Control performed? When are extra Quality Controls required ? 3 month shelf life once opened 20/6/16 28 November 2018 page 10 © 2009 Roche

Quality Control Testing Why Quality Control? This is the only way to ensure meter is working accurately. When to Quality Control? QC expires 3 months after opening – write 3 month expiry date on QC bottle. Mix QC before using (main reason QC fails) – wipe off any crystalising of QC solution from top of QC bottle onto tissue. If meter is used daily – QC should be performed every 24 hours. (refer to Trust Policy) The Inform II will Automatically QC lock out and no patient testing can be performed. If used infrequently – QC should be performed weekly and on day of test. QC should also be performed in the following situations: New Test Strips New QC Solution If meter is dropped New Battery Unexplained result versus clinical appearance How to QC the Inform Meter – Demonstrate how to perform QC Staff being trained must demonstrate how to do a QC test. Documentation of Results: Explain that because the staff log in into the system with User Id’s and scanning all barcodes they are effectively filling out the logbook electronically therefore there is no paper based log book to fill out or retain for the 10 / 25 years. External Quality Assurance: Explain this is a sample sent to all wards from Biochemistry, it tests the accuracy of the meter and also that the user is following procedures (result only known by lab). Explain It is processed like a patient sample, how to complete paperwork & return to laboratory. Everyone’s responsibility to perform EQA samples. Hospital is audited on numbers of tests returned and accuracy. 28 November 2018 page 11 © 2009 Roche

Good Data Recoding - N.M.C “Good record keeping is an integral part of nursing and midwifery practice, and is essential to the provision of safe and effective care. It is not an optional extra to be fitted in if circumstances allow.” To safeguard both patients and staff 10 years for adults , 25 years for children , to be kept on the ward or sometimes by the biochemistry dept. N.M.C – Record keeping – Guidance for nurses and midwives - 2010 28 November 2018 page 12 © 2009 Roche

Failed Quality Control Test What should you do? Check Expiry dates, mix solutions & repeat the test. Change Solutions & Test Strips Contact POC team, Biochemistry Laboratory Remember If the meter continues to fail – cannot use it! 28 November 2018 page 13 © 2009 Roche

Accu-Chek Inform II Inform II Blood Glucose Meter is connected to your hospital laboratory system when in the docking station. Central database within the laboratory Enables complete audit trail for each test Protects Patient Protects Hospital Protects You Patient ID Mandatory Scan or manually enter patient HC number for each test

Accu-Chek Inform II Strip Port Touch Screen Barcode Scanner On / Off Button Base Unit The base unit: The meter should always be placed in this when not in use. The Silver charging points charge the meter The IR Data transfer window allows the upload and down load of information (Not WI-FI) LED status should be Green , if RED or RED and Flashing not communicating unplug wait a few seconds and re-insert plug. If LED is Blue then the meter is Wi-Fi and it’s just a charging station. The Meter The On / Off button will turn the meter on or off. The Touch screen is a Light Sensitive touch screen and looks for changes in light. For effective use touch screen and release. The Test-strip port. The system has been ergonomically designed to encourage hygienic strip handling in the horizontal plane. The Barcode scanner is used to Scan the Patient identification and the barcodes on the Strips for Lot Verification and that of the Qc . Charging Points Data Transfer LED Status Display

Know your base unit…. Green Light – Ready Flashing Red Light – Communication Error Red Light – Power connected & starting up Blue Light – Wifi / Configuration mode

Accu-Chek Inform II (reverse side) Battery Pack: (powers the meter) Reset Button: Use this button to reset the device (reset will not alter configuration Charging Contacts: (These are used to charge the meter when it’s in the base unit 28 November 2018 page 17 © 2009 Roche

Accu-Chek Inform II Blood Glucose Meter OLD VERSION NEW VERSION No Reset button on reverse. Hold on/off button down for 15 seconds to reset Old version reset button RF Slot

General Meter Operation (Scan a barcode) 28 November 2018 page 19 © 2009 Roche

Calibration of the Accu-Chek Inform II Meter Coding is done Centrally Throw away the code chip that comes in every box of test strips The code chip information is loaded by the Point of Care Co-ordinator (POCC) Automatically downloaded into every Accu-Chek Inform II. This calibrates the meter to the strips.

Accu-Chek Inform II Test Strip Container Hinged lid Expiry Date Strip Code Number 28 November 2018 page 21 © 2009 Roche

Accu-Chek Inform II Test Strip Golden End (electrodes) Test Strip – Is robust and can be handled as long as hands are clean, dry & free from alcohol gel. They are dosed at the tip of the strip. (End dosing strip). Under Dosed – The Inform II meter will report a “Type Bad Dose” if the test strip is under filled The Inform II strip also compensates for temperature, humidity & Haematocrit – gives error messages if unable to compensate. The Inform II strip also detects sample type: blood /QC Blood or QC must be placed at the leading edge of the test strip. New strips obtained from? Yellow Window 28 November 2018 page 22 © 2009 Roche

Patient Testing Consent Infection Control Patient preparation Obtaining a sample 28 November 2018 page 23 © 2009 Roche

How To Perform A Patient Test Switch on Inform & enter your operator ID. Main Menu appears. Confirm the current strip lot is being used by scanning in the test strip barcode. Scan your unique Operator barcode. Test Processing Result displayed – Document as per trust policy. Insert a strip when prompted Touch Patient Test Type the patient ID or scan patient barcode. Apply patient blood only when prompted

Results Normal Range = 4. 1 mmol/L – 6 Results Normal Range = 4.1 mmol/L – 6.5 mmol/L Critical Range = < 2.8 mmol/L - >20.0 mmol/L – Laboratory sample MUST be sent If outside Normal/Critical Range - meter prompts “Out of Range” What does this mean? Blood Glucose lower than 0.6mmol. Potentially very high glucose – above 33.3 mmol. 28 November 2018 page 25 © 2009 Roche

Cleaning the Meter 70% Alcohol may be used Follow hospital policy for decontamination

Quality Control Testing Why Quality Control? How often is Quality Control performed? When are extra Quality Controls required ? 3 month shelf life once opened 20/6/16 28 November 2018 page 27 © 2009 Roche

How To Perform A Quality Control Test Switch on Inform & enter your operator ID. Main Menu appears. Insert a strip when prompted Touch Control Test Select Glucose Control test Select your level and scan the QC barcode on the side of the bottle Apply correct Control Solution only when prompted The Inform automatically downloads the QC result into the database Remember to add a comment if the QC fails. Confirm the current strip lot is being used, by scanning the test strip barcode

Failed Quality Control Test What should you do? Check Expiry dates, mix solutions & repeat the test. Change Solutions & Test Strips Contact POC team, Biochemistry Laboratory Remember If the meter continues to fail – cannot use it! 28 November 2018 page 29 © 2009 Roche

Review Results Only Selected Patients results displayed. Press the Review Results button in the Main Menu. Select specific results to view details (e.g. comments, flags, date & time) Scroll the list using the arrow buttons on the right side of the screen. View all results for a specific patient by pressing Patient in the main list,

poct@southerntrust.hscni.net Or Tel: 02838360651 SHSCT - Point Of Care Team Derek McKillop, Dorinda O’Neill or Garerth Prideaux, Biochemistry Laboratory, Craigavon Area Hospital. Contact via email: poct@southerntrust.hscni.net Or Tel: 02838360651 All Performa stock (Log books, batteries, replacement meters) and replacement Inform II bar codes are requested via above POC team.

Remember! Always dock the meter after use and/or on return to your base station. Always enter the correct Patient HC number Never share your barcode Never leave the lid of the strip container open

Thank you for your attention. Roche Diagnostics Ltd. Charles Avenue Burgess Hill RH15 9RY COBAS and LIFE NEEDS ANSWERS are trademarks of Roche This presentation is our intellectual property. Without our written consent, it shall neither be copied in any manner, nor used for manufacturing, nor communicated to third parties. 28 November 2018 page 33 © 2009 Roche