Summary:
Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on lack of patient test reports for review, review of the laboratory's established procedure for i-Stat test reporting and interview with the technical consultant, the laboratory failed to retain i-Stat test reports for at least 2 years after the date of reporting. Findings include: 1. The laboratory began patient testing on the i-Stat analyzer on September 16, 2020 in the sub-specialties of Routine Chemistry and Hematology, with an approximate annual test volume of 900. The laboratory performs the Chem8+ test and the CG4+ test (for Arterial Blood Gas). 2. The laboratory's established test procedure for testing performed on the i-Stat analyzer states, "Follow handheld prompts. Enter Operator ID number as assigned to each user. Enter Patient ID number...Attach printout to Lab Report Form, verifying that patient ID numbers match. Results will be filed into patient (EMR) record under tab of labs." 3. According to the established procedure indicated above, the testing personnel must attach the i-Stat instrument printout to a form titled, "Laboratory Report Form i-Stat Point of Care" and manually fill in the remaining information on the form. The form includes the reference ranges for Chem8+ and CG4+ analytes, and an area to manually write in the following information: Patient Name, DOB, Patient ID#, Test Ordered, Order Attached (Y/N), Ordered By, Date Drawn, Time Drawn, Drawn By, Puncture Site, Modified Allen's Test (Pos/Neg), Critical Results (Y/N), Results Reported To, Reported Via (In person/phone), Time Reported, Comments, Device, Pt RR, SpO2, FIO2, Settings, and RT Signature. 4. No evidence of the 'Laboratory Report Form i-Stat Point of Care' was provided for review during the survey Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- performed on March 30, 2023 for all i-Stat test results which were performed and reported prior to March 31, 2022. 5. The technical consultant interviewed on March 30, 2023 at 10:45am stated that the 'Laboratory Report Form i-Stat Point of Care' for each patient tested prior to 3/31/2022 was thrown away by laboratory staff and not retained for at least 2 years after the date of reporting. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of i-Stat instrument printouts, i-Stat test procedures and interview with the technical consultant, the laboratory failed to follow established policies and procedures to ensure positive identification of the patient's specimen from the time of collection through completion of testing and reporting of results. Findings include: 1. The laboratory began patient testing on the i-Stat analyzer on September 16, 2020 in the sub-specialties of Routine Chemistry and Hematology, with an approximate annual test volume of 900. The laboratory performs the Chem8+ test and the CG4+ test (for Arterial Blood Gas). 2. The laboratory's established test procedure for testing performed on the i-Stat analyzer states, "Follow handheld prompts. Enter Operator ID number as assigned to each user. Enter Patient ID number...Attach printout to Lab Report Form, verifying that patient ID numbers match." 3. Instrument printouts reviewed and printed from the i-Stat analyzer during the survey for two out of two patients, Patient# 8522 from 6-25-2021 and Patient# 5056 from 10-05-2021, revealed each patient was tested for both Chem8+ and Arterial Blood Gas (ABG) testing. 4. The patient ID numbers entered into the i-Stat as indicated above (#8522 and #5056) were not valid patient ID numbers or the patient ID's were incorrect, as these patient ID numbers could not be traced back to specific patients during the survey. 5. The laboratory failed to follow established policies and procedures to maintain positive patient identification on patient specimens throughout the entire testing process on the i-Stat analyzer. 6. The technical consultant interviewed on March 30 , 2023 at 11: 00am confirmed that the laboratory failed to follow established policies and procedures related to the i-Stat analyzer to ensure positive patient identification throughout the entire testing process. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of