Point of Care Testing - Clinitek Status Data Definition Tool This audit is to be completed by the manager or designee on a monthly basis. POCT audits are due by the last day of the month. following the review. Instructions: Indicate Yes, No, NA (Not Applicable) for each question below. Updated 11-10-14 Submit 1 POCT audit per month using the Point of Care Testing - Clinitek Status audit tool. QUESTION STANDARD Has all testing performed in this patient care area been approved by the Diagnostic Laboratories? NOTE: All POCT Testing must be approved prior to implementation. If WT.01.01.01, EP 4 WT.02.01.01, EP 1 & 2 1 unsure of area approval, contact Point of Care personnel. Is there a designated trained trainer with documented current 2 competency? Has the patient care area notified the Laboratory (POC) of changes in 3 the list of testing personnel? WT.03.01.01, EP 2, 3, 4, & 6 YES Yes means you are NOT doing any lab tests that you have not been approved for. Approval comes from the POCT committee. Manager/Educators Person trained by POCT in the office training records last year to train other staff. Emails WT.02.01.01, EP 1 Are current documentation records for training and competency 4 records readily accessible? Can staff produce a copy of the current procedure (hard copy or 5 online)? Has the manager performed a documented review of patient chart documentation to verify that patient results are properly documented 6 per procedure? (Review of Manager log) WT.02.01.01, EP's 1 & 2 WT.03.01.01, EP 3 7 Are all reagents, controls, and kits stored at proper temperature? WT.01.01.01, EP 2 & 6 Are all reagents, controls, and kit boxes labeled with an appropriate 8 expiration date and initials? WT.01.01.01, EP 2 Have QC documentation logs been completed as required by 9 procedure? 10 Have corrective actions been documented? 11 Are all QC records kept for a minimum of 2 years? LOCATION POCT testing book WT.01.01.01, EP 5 Have sent POCT updates when someone leaves work area or new staff comes to work area. Manager/Educators Orientation records must be kept office training records permanently, annual recertifications must be kept for 2 years. Computer/POCT Can find procedure manual POCT testing book Manager has done quarterly chart audits. WT.05.01.01, EP 4 Where supplies are kept Where supplies are kept Controls are refrigerated until needed. Strips at RT Strips are labeled with open date, controls with 31 day altered expiration date and initials QC Log Book Package insert matches control lot in use, and QC is done daily when patients are tested. Problem log QC Log Book If had problem it is noted Yes, if you have your records WT.04.01.01, EP 1 & 2 WT.05.01.01, EP 1 WT.01.01.01, EP 2 WT.05.01.01, EP 5 Has the manager or designee performed a weekly review and sign off of 12 quality control and other test specific required documentation? Is all original documentation of patient results retained for a minimum 13 of 2 years? 14 Are maintenance records available and complete? WT.01.01.01, EP 2 WT.04.01.01, EP 1 & 2 WT.05.01.01, EP 1 WT.05.01.01, EP 5 WT.05.01.01 EP 4 & 5 QC Log Book There is a signature to indicate reviewed weekely. Instrument printouts/Log book On QC Log Are they accessible for last 2 years Records are complete