04 ACCU-CHEK INFORM II GLUCOSE METER

Transcription

1 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 1 of ACCU-CHEK INFORM II GLUCOSE METER SECTION: Point-of-Care Testing WRITTEN BY: Althea Reid TYPED BY: Althea Reid RECORD MANAGEMENT DISK ID: H:\Master_Policy_Procedure_Folder\PG\Procedures\POCT\SOP\SYS POC-04 V2 Accu-Chek Inform II Glucose Meter.doc IMPLEMENTATION DATE: 4/6/16 CHANGE CONTROL ORIGINAL DATE: 10/07/13 LAST REVISION DATE: 03/15/16 REVISIONS MADE: Clarified the process for repeating and reporting critical values on page 8 LOCATIONS OF COPIES: Master Document File, App Copy 1: PGHC, App Copy 2: LRH, App Copy 3: BHC, DHS intranet COPIES APPROVED: 5 (Original plus 4 controlled copies). APPROVAL PROCESS LABORATORY MANAGER (PGHC): DATE: LABORATORY MANAGER (LRH): DATE: RAPID RESPONSE LAB SUPERVISOR (BHC): DATE: SYSTEM DIRECTOR OF CLINCIAL LABORATORIES: DATE: MEDICAL DIRECTOR: DATE: REVIEW PROCESS REVIEWER S SIGNATURE DATE REVIEWER S SIGNATURE DATE ARCHIVE PROCESS DATE REMOVED: BY: # OF COPIES: REASON: MEDICAL DIRECTOR: DATE:

2 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 2 of 11 Purpose 04 ACCU-CHEK INFORM II GLUCOSE METER Point-of-Care Testing (POCT) is intended to provide more rapid results than can be achieved in a traditional laboratory setting. The ACCU-CHEK Inform II system is used to monitor the effectiveness of glycemic control in patients. It is intended to supplement, and not replace, clinical laboratory testing. The meter must not be used in the diagnosis or screening of diabetes mellitus, nor for the testing of cord blood samples. Capillary, venous, neonatal, and arterial whole blood specimens may be used for testing on the ACCU-CHEK Inform II blood glucose monitoring system. Principle The ACCU-CHEK Inform II glucose monitoring system is used for the in vitro testing of glucose levels using whole blood samples. The enzyme on the test strip, mutant variant of quinoprotein glucose dehydrogenase from Acinetobacter calcoaceticus, recombinant in E. coli, converts the glucose in the blood sample to gluconolactone. This reaction creates a harmless electrical DC current that the meter interprets for a glucose result. The sample and environmental conditions are also evaluated using a small AC signal. The system is calibrated with venous blood containing various glucose concentrations and is calibrated to deliver plasma-like results. The reference values are obtained using a validated test method which is referenced to the hexokinase method and is traceable to an NIST standard. Refer to the test strip package insert for complete, updated information. Equipment and Reagents ACCU-CHEK Inform II System: The meter used for testing. The barcode scanner emits a laser beam. Do not stare directly into the laser beam. Use only your fingertip to lightly tap the screen. Do not touch the screen with a pen, pencil, or any sharp-edged object. The base unit - which recharges the meter battery pack and supports wired or wireless communication with a data management system. Accessory box for storing strips, controls, and lancets.

3 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 3 of 11 ACCU-CHEK Inform II Test Strips: Strips are available from the storeroom and must be stored at temperatures between 4-30ºC in original vial with the cap tightly closed. Do not freeze. Keep away from heat and direct sunlight. Use test strips at temperatures between ºC and 10-80% relative humidity. Strips should be used immediately after being removed from the vial and the vial should be recapped immediately after removing the strip to ensure the integrity of the remaining strips. Strips do not expire until the use by date (manufacturer s expiration date), provided the vial is recapped immediately each time and all storage requirements are met. Discard unused strips if they are found outside the vial. Never transfer test strips from their original vial to a new vial, or to any other container. Each new lot number of strips is coded by the POCT staff. ACCU-CHEK Safe-T-Pro Plus Lancets: Acquire from storeroom and keep at room temperature. Lancets are for single use only. Simple two-step procedure for use after thoroughly cleaning the sampling site on the patient. Twist off protective cap Firmly place Accu-Chek Sate-T-Pro lancet against fingertip and press the blue trigger button. ACCU-CHEK Control Solutions: 2 levels Level 1 (Lo) and Level 2 (Hi). Acquire from storeroom. Store at room temperature (between 15º to 32ºC). Control solutions expire three (3) months after the bottle is opened. Upon opening, record the 3-month expiration date on the vial. Write as Exp. and the 3-month date. Do not use beyond the 3-month expiration date or the manufacturer s printed expiration date on the bottle. Discard any unused portion after 3 months or the manufacturer s expiration date, whichever comes first. Gently invert, do not shake, control solutions before use. Wipe the tip of the bottle with a lint free cloth and reseal tightly after use. Quality Control (QC) testing will be performed to verify that the system is operating within the manufacturer s specifications. Control solutions will be run, as outlined below, once every 24 hours while the meter is in use. REQUIRED will be listed beside each control that must be done prior to proceeding. The meter will give a prompt indicating when control testing is due next. Results must be within 3 SD of the mean for the low and high quality controls to PASS and proceed to patient testing. The meter features a QC lock-out feature that will not allow patient testing if there is a QC failure. Performance of QC should be rotated among the certified users to provide an additional method of user competency. Control solutions should also be tested when a patient s glucose result is not consistent with his/her symptoms, when troubleshooting, and to confirm the proper operation of an instrument if it has been dropped. Other quality testing such as linearity and correlation will be performed by POCT staff.

4 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 4 of 11 Cleaning Following the hospital infection control policy, the operator must disinfect the meter before and after each patient. Use Sani-Cloth Wipes or Clorox Germicidal Wipes to clean the display and the case of the meter, being careful to remove any traces of blood. Squeeze the excess liquid from the wipes before using. Allow the solution to remain on the meter for 3 minutes then dry the meter thoroughly with gauze. Never allow the inside of the meter to get wet as this could permanently damage the meter. Turn the meter off before cleaning. Quality Control Procedure Always touch to scan any barcode Press the power button at the bottom of the unit to turn on the meter. Performing Self Check will appear on the screen. The meter will first perform internal checks and may not be turned off during this period. On the Power Up screen, check if the date (lower left corner) and time (upper right) are correct. If not correct, notify the POCT staff. Scan your operator ID barcode when prompted for operator ID. The name of the operator will be displayed on the screen. Select Control Test from the Main Menu screen. Scan the barcode on the side of the first bottle of control you are testing. It is not necessary to run the control levels in order; either L1 or L2 can be done first. Scan the test strip barcode when prompted. The meter will confirm the lot number of the test strip. The monitor will then prompt for a test strip to be inserted into the test strip port at the top of the monitor. Remove a test strip from the test strip vial and recap the vial. Hold the test strip so the lettering ACCU-CHEK is facing upward. Insert the test strip into the test strip port as far as it will go in the direction indicated by the arrows on the test strip. The meter will beep when it detects the test strip. The meter will prompt you to apply the solution by displaying a flashing drop on the screen above the picture of the test strip. Wait until the flashing drop appears before applying the control solution. Gently invert control solution bottle 3-4 times, then apply large drop to the target area (the front edge) on the test strip. The meter will beep once it detects sufficient solution. The hourglass icon indicates that the test is running. The meter will beep when the result is ready.

5 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 5 of 11 QC result will display as PASS or FAIL. If the control reads FAIL with a flashing COMMENT, provide a reason in the comment and repeat the procedure. If the control reads FAIL a second time, take the meter to the lab/poct office, document the issue on the defective instrument log, and sign out a spare glucometer if needed. The POCT staff will troubleshoot the issue and repair or replace the meter if necessary. Remove the used test strip and discard using Standard Precautions. Repeat the procedure using the next control level. Turn the meter off. Clean the meter and place in the charging base. Patient Procedure No special patient preparation is required. All tests require a physician order. Perform testing at times specified per the physician s orders on chart. For Neonates: A heel warmer may be placed on infant s foot prior to specimen collection to facilitate blood flow. Perform testing at times specified by the neonatologist, pediatrician, or other physician. Test should only be used as a screening test to monitor the glucose of those babies who have been identified as being at risk for hypoglycemia. Critically ill: The meter has not been approved for testing in the critically ill. Results must be interpreted with caution when testing critically ill patients. If results are questionable, glucose testing for the critically ill patient (as defined below) must be sent to the laboratory. For adults: A patient with a mean arterial pressure (MAP) less than 60 and with evidence of tissue underperfusion; or with hematocrit of less than 10% or greater than 65%. For neonates: A neonate with impairment of one or more organ system to include needing respiratory support of HFNC or more, pressor supports, or sepsis with unstable vital signs. Specimen Collection: Standard Precautions must be observed when the operator is handling blood specimens. Note: For isolation patients, place the glucometer in a biohazard specimen bag before taking the meter into the patient s room. Perform testing with the strip port facing the opening of the specimen bag. See section on Infection Control. Wash hands and put on gloves. Check the patient s armband to assure positive identification of the patient before performing any blood specimen collection. Hospital policy requires the use of two identifiers. Identify patient according to the hospital policy.

6 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 6 of 11 Select the puncture site for performing the fingerstick. The puncture should be made into the lateral-medial (side) of the pulp of the fingertip. Cleanse the patient s finger with sterile alcohol prep and allow the site to air dry so the sample is not contaminated or diluted with alcohol. Using a Safe-T-Pro single use lancet with normal depth 1.8 mm, perform the fingerstick. Note: Unistix may also be used if available. Squeeze the finger gently. Avoid excessive squeezing of the patient s finger which could contaminate the blood with tissue fluids and cause inaccurate results. Use a clean gauze pad to wipe away the first drop of blood. Gently squeeze the finger again to form another drop of blood for testing. After the blood has been collected and tested, attend to the puncture site to assure bleeding has stopped. The puncture site may be covered with a bandage. Discard lancets in a sharps container. Remove gloves and wash or foam hands. For Neonates Wash your hands and put on gloves Check the baby s identification band to assure positive identification before performing any testing. Hospital policy requires the use of two identifiers. Select the puncture site for performing the heel stick and warm it to increase blood flow. If the foot is rather small or cold, place a heel warmer on the site for about 5 minutes prior to lancing the site. Note: The puncture should be made on the plantar surface of the lateral part of the heel. Cleanse the baby s heel with sterile alcohol prep and allow the site to air dry. Holding the heel gently but firmly, use the NeatNick Lancet-Full Term (bright orange in color) to perform the heel puncture for full term babies. Use Preemie Heel (bright green color) for premature infants. Holding the heel may be done in one of the two ways- place the forefinger around the ankle and the thumb over the arch of the foot; or place the forefinger over the arch of the foot and the thumb at the ankle below the puncture site. Remove the sterility cap with a simple twist and discard. Hold the lancet against the side of the heel and press the release button to initiate the spring lancet. The safety lancet will automatically retract into the protective outer shell. If blood is not flowing easily, gently use a kneading motion to encourage blood flow. After the blood has been collected and tested, attend to the puncture site to assure bleeding has stopped. The puncture site may be covered with a bandage. Discard lancets in a sharps container. Remove gloves and wash or foam hands. Patient Testing: Always touch to scan any barcode

7 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 7 of 11 Press the power button at the bottom of the unit to turn on the meter. Performing Self Check will appear on the screen. The meter will first perform internal checks and may not be turned OFF during this period. Scan your operator ID barcode when prompted for operator ID. The name of the operator will be displayed on the screen. Select Patient Test from the Main Menu screen. Scan the patient s arm band for the patient ID. The 9-digit finance (FIN) number is used as the patient ID. If the armband will not scan you may manually enter the 9-digit FIN number as the patient ID. Look at the glucometer screen to verify that the information displayed is for the correct patient and touch the to confirm. Note: If you scan or enter the medical record (MR) number as the patient ID, the patient s result will not upload to Cerner Millennium. If the patient is unregistered due to an emergency (L&D, ED, NICU, MCH) use your cost center number as the temporary patient ID. Follow the instructions in procedure POC-16 Unregistered Patients and Use of the I-Stat or Accu-Chek to document results and fax to the POCC at the end of your shift. When prompted, scan the barcode on the test strip vial. The meter will confirm the lot number of the test strip. The monitor will then prompt for a test strip to be inserted into the test strip port at the top of the monitor. Remove a test strip from the test strip vial and recap the vial. Hold the test strip so the lettering ACCU-CHEK is facing upward. Insert the test strip into the test strip port as far as it will go in the direction indicated by the arrows on the test strip. The meter will beep when it detects the test strip. The meter will prompt you to apply the patient sample by displaying a flashing drop on the screen above the picture of the test strip. Do not apply the sample until the flashing drop appears. Apply the patient sample to the front edge of the test strip by touching the strip to the puncture site. Blood is pulled into the strip by capillary action. The meter will beep once it detects sufficient sample. The hourglass icon indicates that the test is running. Remove test strip once the result is displayed and discard using Standard Precautions. Results Screen Results will display on the screen in 5 seconds. There are 3 categories: Result with Range means the result is within the normal (reference) range. Touch the range icon if you want to view the reference ranges.

8 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 8 of 11 Result with a flashing red arrow means the result is out of range. The direction of the arrow indicates if the result is above or below the reference range. Out of Normal Range will be displayed. Critical results will display with Out of Critical Range. Repeat the test to verify the value. Repeated results must be within +/- 10% of the original result to be valid. Notify the physician or nurse assigned to the patient. Enter comment to document notification. If the repeated value is greater than +/- 10% of the original value, order a stat glucose and send to the laboratory immediately. Results outside the reportable range - greater than 600 mg/dl will display as RR HI. Result less than 30 mg/dl will display as RR LO. These specimens require a repeat blood glucose check and collection of a blood specimen for STAT blood glucose to be performed by the Laboratory. For these results, order a stat glucose and send to the laboratory immediately. Touch to select a comment if necessary. For example - will repeat test, physician notified, send specimen to lab. You may also type a comment. Once a comment is entered, touch to return to the results screen Touch the button to confirm the result and wirelessly transmit results to Cerner. Placing the meter in a wired base will also transmit the results to Cerner. Turn the meter off. Clean meter after each patient. Dock meter after use to ensure timely transmission of results. Meter must be kept in the docking base when not in use. Follow nursing procedures for manually recording the glucose result on the Point of Care form in Cerner. Result Ranges Reportable Range: mg/dl; verified by in-house linearity performed prior to implementation. Reference Range: mg/dl For Neonates: mg/dl Critical Values: Notify physician of all critical values and document notification in the patient s electronic chart - Less than 60 mg/dl or greater than 400 mg/dl. - Less than or equal to 60 mg/dl or greater than or equal to 300 mg/dl for Critical Care Center and Labor & Delivery patients.

9 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 9 of 11 For neonates: Less than or equal to 40 mg/dl or greater than or equal to 150 mg/dl. Critical values and the notification of the physician MUST be documented in the patient s chart. Use caution when result is a critical value. The test should be repeated and a blood specimen collected by nursing personnel and immediately brought to the laboratory for STAT glucose testing. Limitations Whenever the glucose result obtained by the meter does not match the patient s clinical presentation as determined by trained nursing personnel or physician, draw a venous specimen and send to the laboratory for testing. Acceptable hematocrit range is %. For hematocrit values outside of these ranges, specimen must be sent to the laboratory for glucose testing. In situations of decreased peripheral blood flow, fingerstick blood testing may not be appropriate, as it may not reflect the true physiological state. Examples include, but are not limited to: severe dehydration caused by diabetic ketoacidosis or the hyperglycemic hyperosmolar nonketotic state, hypotension, shock, or peripheral vascular disease. The following compounds, when determined to be in excess of their limitation, may produce falsely elevated glucose results: Galactose >15 mg/dl. Confirm glucose values in neonates demonstrating symptoms of galactosemia by sending a specimen to the laboratory for testing. Lipemic samples (triglycerides > 1800 mg/dl) Blood concentrations of ascorbic acid >3 mg/dl Do not use any whole blood containing fluoride (gray top) for meter testing. Fluoride interferes with the test reaction. May collect specimens in sodium heparin, lithium heparin, or EDTA tubes and test within 30 minutes. Do not use plasma or serum for testing. The performance of this system has not been evaluated in the critically ill. Infection Control Guidelines Always follow standard precautions when collecting specimens, performing test procedures, and cleaning blood glucose monitoring equipment. Used personal protection equipment (PPE) should be discarded according to hospital infection control policy. The Accu-Chek Inform II meter must be disinfected before and after use for each patient. Isolation patients: Always observe the hospital infection control policy. Place meter in a biohazard specimen bag with the clear side of the bag facing upward. Ensure meter is completely covered.

10 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 10 of 11 Close the seal while making allowance for the test strip to extend through the seal of the bag. Use the touch screen on the ACCU-CHEK Inform II and follow the prompts and displays directly through the bag. Perform testing using the same procedure as described above. Operator Certification Only certified operators will be able to access the glucometer to perform patient testing. All operators will be assigned an operator identification number and barcode badge after successfully completing the competency training during new employee orientation. DO NOT share your assigned barcode with anyone. Agency nurses can be trained on the unit by a nurse educator or manager but cannot perform testing until the training documentation is received by the POCT staff. All eligible employees are recertified annually. Operators with expired certifications will be locked-out of the system. Recertification includes direct observation of patient testing and/or quality control testing, and successfully passing a written quiz. Operators who experience more than 3 discrepancies between repeat testing within a calendar year will be locked out of the system until they have been retrained. Instrument Problems If a meter is visibly damaged or fails to operate as expected, return it to the POCC or laboratory and complete the defective instrument log. A loaner meter will be issued as needed. Touch Screen Icons Barcode icon used for scanning Main menu icon returns operator to Main Menu Eraser icon used as clear button Check icon is used to confirm result or comments selected Empty speech bubble is the icon used to select a comment Speech bubble with text lines allows operator to enter free text comment

11 Point-of-Care Testing Procedure SYS: POC-04.V2 Page 11 of 11 Last attempt to send results was successful. Last attempt to send results was NOT successful Icon displayed at bottom of the meter screen confirms wireless connectivity Indicates battery status Battery with Lightning Bolt alerts that battery is charging References ACCU-CHEK Inform II Test Strip package insert, published 2013 ACCU-CHEK Inform II Blood Monitoring System Operator s Manual, published March 2013 ACCU-CHEK Inform II Controls package insert, published ACCU-CHEK Inform II Linearity Test Kit package insert, published 2012.