Inform II Glucose Meter

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1 Inform II Glucose Meter Copy of version 1.5 (approved and current) Last Approval or Periodic Review Completed Next Periodic Review Needed On or Before 2/9/2015 2/9/2017 Effective Date 2/9/2015 Uncontrolled Copy printed on 2/10/2015 Printed By Organization Teri Kroll St. Mary's Hospital -- Madison Author Brenda Warren/Rachel Peters Comments for version 1.5 Substitute Level 1 and Level 2 control for Low and High control. Clarified use of PPE when using disinfectant wipes per Infection Control. Approval and Periodic Review Signatures Type Description Date Version Performed By Notes Periodic review Designated Reviewer 2/9/ Brenda Warren Periodic review Periodic review Designated Reviewer Designated Reviewer 2/6/ Brenda Warren 1/16/ Brenda Warren No changes required Approval Lab Director 9/19/ Joel Mendelin, MD Recorded when document uploaded to MediaLab Approvals and periodic reviews that occured before this document was added to the MediaLab Document Control system may not be listed. Prior History Reviewed/Revised:(bold) BLW/RP/KS 5/13/13 Updated procedure from pre-go-live version. Reviewed/Revised:(bold) BLW 7/16/13 Clarified Pre-Analytical patient ID. Version History Version Status Type Date Added Date Effective Date Retired 1.5 Approved and Current Minor revision 2/9/2015 2/9/2015 Indefinite 1.4 Retired Minor revision 2/6/2015 2/6/2015 2/9/ Retired Minor revision 10/24/ /24/2014 2/6/ Retired Minor revision 10/7/ /7/ /24/ Retired Minor revision 9/15/2014 9/15/ /7/ Retired First version in Document Control 11/22/2013 3/26/2013 9/15/2014 Linked Documents

2 Exchanging an Inform Meter for a Defective One Inform II Glucose Meter New QC Lot Check Log Inform II Glucose Meter New Strip Lot Check Log To Exchange An Inform II Meter Inform II Meter Replacements Log

3 Title: Inform II Glucose Meter Manual: POC Clinical POCT Old Procedure Number: Medical Director: Administrative Director: Distribution: Joel Mendelin, MD Mike Baron St Mary s-madison SharePoint Sun Prairie Emergency Center Other: Staff Distribution: All Lab Staff Other: All departments with Inform II Meters Procedure Owner: Procedure Author: Prerequisite / Concurrent Procedures: Attachments: Related Documents: Brenda Warren Brenda Warren, Rachel Peters Inform II Glucose Meter New Strip Lot Check Form Inform II Glucose Meter New QC Lot Check Form Accu-Chek Inform II Troubleshooting and Replacement Instructions Laboratory Technical Procedure PURPOSE: This procedure describes all steps required for operation, quality assurance, and maintenance of the wireless Inform II glucose meters by trained staff following the regulations of the accreditation agencies College of American Pathologists (CAP) and Joint Commission (JC). All patient glucose testing will be performed on hospital meters and hospital meters are only for patient glucose testing. All glucose tests must have a corresponding physician request. Results will be documented in the Electronic Health Record. PRINCIPLE: The Accu-Chek Inform II system quantitatively measures glucose in whole blood. 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. This test method is referenced to the hexokinase method and is traceable to an NIST standard. Uncontrolled copy printed by Teri Kroll on 2/10/2015. Page 1 of 12

4 Cleaning: 1. After each patient test: a. Meter/case must be cleaned with a wrung-out, hospital approved, disinfectant wipe after each patient test, prior to placing in case or taking into a clean area. b. Two-step process required when equipment has visible contamination i. 1st step to remove contamination or bio burden ii. 2 nd step to disinfect (using second disinfectant wipe) according to label of product used (for CaviWipes 1, required wet-time is 1 minute; Dispatch for c- diff, wet time is 5 minutes) c. Use appropriate PPE to protect yourself from Chemical and Blood and Body Fluids 2. Daily cleaning: a. Meter must be cleaned with a wrung-out disinfectant wipe just prior to the required every 24 hour QC checks 3. Gloves required 4. Eyewear if risk of splashing 5. Wipe off the screen and the laser with a soft cloth as needed to prevent residue buildup. 6. Enter meter cleaned option when doing the daily QC check after cleaning the meter. CALIBRATION PERFORMED BY LAB: Each box of test strips contains a code key. Each code key belongs to a single lot and provides important information about the lot-specific properties of the Accu-Chek Inform II test strip. The properties of each lot number of test strips are downloaded (as a code file) from the code key into the Accu-Chek Inform II system by means of the code key reader. A code file is uploaded into the Accu-Chek Inform II system for every test strip lot that is received by the Point of Care (POC) area of the Laboratory. The code file for each in-use test strip lot resides in all meters so that end users on nursing units are able to access and select the correct test strip lot for testing. New test strip codes are uploaded into the system by the POCC when the new lot of strips are validated for use. The nursing units can discard the code chip that is packaged with each vial of strips. QUALITY CONTROL - EXTERNAL: Quality control testing is performed as a primary means of ensuring on-going proper performance of the Inform II system. Level 1 and Level 2 liquid quality control testing is performed routinely on a daily basis. Other times when quality control is performed: 1. When a new test strip vial is opened and placed into service. 2. When opening a new box of quality control solutions. 3. If the meter is dropped. 4. If the patient results are in question. 5. Acceptable quality control results are defined as those results that PASS. Quality control testing results must PASS prior to performing patient testing. Quality Control lockout feature prevents patient testing if quality control fails. Uncontrolled copy printed by Teri Kroll on 2/10/2015. Page 4 of 12

5 QUALITY CONTROL PROCEDURE: 1. Turn on Inform II meter 2. Scan your operator ID (barcode on your employee badge) or manually enter ID number. 3. From the Inform II Main Menu touch Control Test 4. Barcode scan the level of control that you wish to test. 5. Barcode scan the strip vial. 6. Remove a test strip from the vial and immediately recap the vial. 7. Insert a test strip into the meter following the icon on the screen. 8. Wait until flashing drop appears (5 second delay), then touch and hold control solution to the front tip of the strip. a. Once sufficient sample has been detected, the measurement begins. An hourglass icon indicates that the measurement is in progress. 9. The measurement is complete when the result is displayed on the meter screen. 10. Remove the test strip and dispose of it in the trash. 11. Touch the comment button to enter an appropriate comment(s). 12. Touch the check button to confirm the result. 13. Interpretation of Quality Control Results: a. Results are displayed on the screen as PASS or FAIL. Any Fail is an indication that the system may not be performing correctly for patient testing or the control solution may be contaminated/dehydrated. b. QC lockout will prevent patient testing if either or both control solutions FAIL. LINEARITY TESTING EXTERNAL: Linearity testing is performed by the Laboratory as a means of validating the reportable range for all new or reconditioned glucose meters. Levels 1, 3, and 6 are run in duplicate and the results graphed through RALS. Linearity testing is performed on all new or replacement meters during check-in and when checking in a new lot of glucose strips. PROCEDURE PERFORMING A PATIENT TEST: 1. Assemble supplies (Inform II meter, test strip vial, lancet, gauze, antiseptic wipe, gloves.) 2. Assess the patient for any indication that bedside glucose testing may not be appropriate. 3. Take the meter and testing supplies to the patient location. 4. Wash hands and don gloves and PPE as required by infection control and isolation policies and procedures. 5. Greet and identify the patient using 2 identifiers. 6. Explain the procedure to the patient. 7. Turn on the Inform II meter. 8. Scan your operator ID by scanning your employee badge or enter 8-digit employee ID manually. 9. From the Main Menu, touch Patient Test. 10. Scan the patient wristband barcode with the Inform II meter. 11. Scan the barcode on the vial of strips. 12. Remove a test strip from the vial and immediately recap the vial. 13. Insert the test strip into the meter in the direction of the arrows with lettering facing upward. 14. Prepare the finger for lancing following the procedure above. Uncontrolled copy printed by Teri Kroll on 2/10/2015. Page 5 of 12

6 TROUBLESHOOTING: 1. If the error message, Strip Defect Error appears on the display, the test strip may be defective or the blood glucose result may be below the meter s measurement range. Repeat test with a new test strip. 2. If the meter displays Type Bad Dose, there may be insufficient amount of blood on the test strip. Repeat the test using a new test strip, ensuring proper sample application. 3. If you dose the strip before the drop appears (5 seconds after putting the strip in the port) it will give the error code E Repeat the test. 4. Out of range Quality Control will show FAIL a. Repeat the QC solution verifying the correct level of QC is run. If the repeat passes, proceed with patient testing. b. If the repeat fails, run the other level of QC. If that level also fails, obtain a new vial of strips from PYXIS and repeat both levels of QC. c. If QC fails with the new strips: i. Obtain a new box of QC solutions from PYXIS. ii. Run both levels of QC on the old strips. If these controls pass, discard the old QC solutions. iii. Run both levels of QC on the new vial of strips and if those pass, leave both vials of strips in the accessory box. 5. A soft reset should be performed*: a. Will not turn on b. If the screen is unresponsive *Hold ON/OFF button for at least 12 seconds for soft reset. **After a soft reset both levels of quality control should be performed. 6. In case of a malfunction of the wireless transmission, there is a base unit wired to the network to download the meters on each nursing unit. These base units will be labeled Network. Some units have 2 wired base units. a. If the Network base has a flashing red light, this indicates it is not connecting to the network. Check all connections between the base unit and the wall. 7. If you are unable to get your meter to work after following these suggestions: a. Call ext and leave a message with meter number and description of the problem. b. If you do not get a response from the 5331 ext. and you need your meter replaced quickly, call the Point of Care Coordinator (POCC) of the lab at ext If the POCC is not available, try the DNE s at ext The DNE s will be able to re-direct your call to the appropriate person if they are unable to take care of it themselves. c. After hours, on weekends or when you are not able to get a quick response, you may exchange your meter for a different one in the lab. i. Call 6908 and let them know that you need to get a different glucose meter. They may not be able to answer all questions but will be able to exchange your meter. ii. Clean your meter with a hospital approved wrung-out disinfectant wipe. iii. Place a note on your meter explaining the problem and anything you have done to try and correct it. iv. Take the meter to the lab and get a replacement. Make sure to run QC prior to doing patient testing. Uncontrolled copy printed by Teri Kroll on 2/10/2015. Page 7 of 12

7 QUALITY ASSURANCE PROGRAM: v. The meter will have Training come up as the location until the Point of Care Coordinator is able to change it in lab computer. Call the Point of Care Coordinator at ext if you notice a meter is showing Training as its location for more than 48 hours after exchange. 1. Orientation, training, and competency assessment of Inform meter operators: a. Orientation and initial training for glucose meter operation/policies/procedures is conducted by the Diabetes Nurse Educators (DNE s)/lab POCC. Initial training consists of, with observation by the DNE s/lab POCC, running two levels of control, running one patient test, and passing a written exam. Records of this initial training will be kept in the Laboratory, and the RALS-Plus computer system, and hospital LMS (Learning Management System). b. Inform II meter operators consist of staff that have been trained by the DNE s/lab POCC and documented in the RALS-Plus computer as proficient to perform patient glucose testing c. Only DNE s/lab POC-trained staff are certified to perform patient glucose testing. The trained glucose operator MUST use only their own Operator ID, never share their ID with another operator, and never use another operator s ID. Failure to follow this process is in violation of CAP Checklist number CAP POC Records indicate (by initials, signature, etc.) who performed each test. d. Recertification of the POC Reps from each of the nursing units performing Inform II glucose testing is performed annually by the DNE s/lab POCC. Recertification consists of passing the online quiz, running two levels of QC that pass, and being observed correctly performing a fingerstick glucose test e. Recertification of the staff on the nursing units is performed annually by the POC Reps, utilizing the same process as indicated in e above. The POC Reps act as liaisons between their area and Laboratory POCC/DNE s to maintain all staff current with policies/procedures and update staff with new information as needed. 2. Pre-Analytical QA Components: a. Positive patient identification is accomplished by using two patient identifiers which include scanning the barcode on the patient s wristband (as one identifier) with the Inform II meter and one or more of the following (per nursing policy): i. Patient s statement of his/her first and last name. ii. Patient s statement of his/her date of birth (month/day/year). iii. Account Number iv. Medical Record Number v. Identification number from Blood Bank red band. b. In cases when the armband will not scan, print a new armband or request one from admissions. If it is an emergency and you cannot wait for a new armband, manually enter the CSN number from the armband (including the leading SMH). Uncontrolled copy printed by Teri Kroll on 2/10/2015. Page 8 of 12

8 i. In areas where patients may not yet have an armband or CSN number, enter the last name, first initial of first name and the date of birth. (ER, Birthsuites, NICU, MICU) ii. In case of an emergency situation (code) involving a non-patient, enter (eleven 7 s). The glucose meter operator will call ext with the person s identifying information (first and last name, date of birth, and CSN iii. number if available) and date and time of test as soon as it is available. All glucose testing needs a physician s order. Therefore, self-testing or testing visitors (other than an emergency situation) is not permitted. c. Inform II operators receive information during training about patient conditions such as DKA, shock, dehydration and heart failure which affect peripheral circulation and can render a fingerstick glucose value inaccurate. For more detailed information, refer to the strip insert. d. The patient s finger/heel will be appropriately cleaned and dried prior to performing the fingerstick/heelstick. The first drop of blood will ALWAYS be wiped off before collecting a drop for testing. 3. Analytical QA Components: a. The glucose test strip must have the yellow window completely filled with blood or the meter will not complete the test, and the test will need to be repeated. b. In cases when a patient consistently has a glucose value above 500 mg/dl (or below 40mg/dL) for an extended period of time, it is recommended that a lab draw for verification should be performed and documented once per 24-hour period. c. Quality Control (QC) results for the Inform II glucose meter are recorded electronically by the meter. d. All control bottles, Level 1 and Level 2, are dated 3 months from the date opened. (Ex: Opened 02/15/13, discard date would be 05/15/13). e. All controls and test strips are discarded upon reaching their manufacturer expiration or written discard date, whichever comes first. f. For the glucose strips to be valid for use until the expiration date on the vial, the cap must be tightly closed immediately after removing a strip. g. Level 1 and Level 2 controls are run each 24 hours that patient testing is performed. h. The Inform II glucose meters are programmed so that patient testing cannot be performed unless Level 1 and Level2 controls have been successfully performed in the previous 24 hours. i. Other times when QC might be warranted: i. When opening a new vial of strips. ii. When opening a new set of control solutions. iii. If the meter is dropped. iv. If the meter requires a soft reset. j. Whenever a QC FAIL s, the test must be repeated and a comment entered to document corrective actions taken. The meter cannot be used for patient testing until both levels of QC have passed. k. Meters are cleaned after each patient, once every 24 hours, and as needed. l. Meters are to be docked in the base unit at all times that patient testing is not being performed. This procedure recharges the battery in the meter. Uncontrolled copy printed by Teri Kroll on 2/10/2015. Page 9 of 12

9 f. Generate monthly and quarterly statistics, as needed. g. Review flagged glucose results and sends to nursing units for a return call with the correct patient ID. h. Check out new lots of glucose strips and controls. 2. Nursing POC Liaison a. Provide regular communication with Nursing POC Reps and report to appropriate Councils as needed. b. Keep reports, training and recertification documents on file for 2 years in the POC area of the Laboratory. c. Take PT samples to nursing units three times/year and have a variety of nurses perform the PT testing samples for glucose. d. Troubleshoot Inform meters as needed. e. Train or has DNE s train new CNA classes and RN classes. 3. DNE s a. Teach RN orientation classes on the Inform II glucose meters. Assist with CNA training when necessary. b. Enter new trainees information into RALS-Plus. c. Assist with Proficiency Testing Samples. 4. POC Reps a. Maintain POC Rep Certification for POC Tests performed on their nursing unit. Schedule istat, Urine Dipstix, Breathalyzer, and HemoCue recertifications with the laboratory POC Coordinator as appropriate for your unit. b. Attend scheduled POC Rep meetings (2-4 per year). c. All POC Reps must attend the Recertifying Meeting (first meeting of the year). d. POC Reps that are recertified can recertify the other staff on their unit and are responsible for directly observing a correctly performed patient test and meter cleaning by each staff person who is being recertified. e. Check a minimum of every 2 weeks for new information regarding POC testing. f. Update staff on any changes regarding POC Testing through staff meetings, posting notices, etc. g. Notify Nursing Liaison or POC Coordinator of staff changes to allow updating of unit operator logs. h. Perform troubleshooting of POC equipment/tests prior to calling the 5331 line for assistance. i. Verify that new staff have been trained by the DNE s on POC tests prior to performing these tests. j. Communicate CLIA, CAP, or JC regulations to staff as it pertains to the POC testing on the nursing unit. k. Review POC procedures/policies and suggest changes to POC Nursing Liaison or Laboratory Point of Care Coordinator. l. Be available during unannounced CAP inspections to answer questions by the Inspectors. m. Keep POC Binder up-to-date in case of downtime. Uncontrolled copy printed by Teri Kroll on 2/10/2015. Page 11 of 12

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