Tukhs Cardiovascular Medicine - Switzer

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on the review of the CMS116 test lists, Individualized Quality Control Plan (IQCP) for the Abbott i-STAT chemistry analyzer S/N 424269, i-STAT quality control (QC) records from 10/7/22 to 3/12/24, lack of documentation for the failure to perform QC as required, the "POC IQCP Annual Assessment" for 2022, and interview with technical consultant (TC) #1, the laboratory failed to re-evaluate the IQCP after the QC interval was not met and implement correct actions (CA) as needed for nine of nine analytes reported. Findings: 1. Review of the CMS 116 application revealed the Abbott i-STAT chemistry analyzer is used to perform the following analytes: sodium (Na), potassium (K), chloride (Cl), total CO2 (tCO2) ionized calcium (iCa), glucose (Glu), blood urea nitrogen (BUN), creatinine (Creat), and B-type natriuretic peptide (BNP). 2. Review of the IQCP for the Abbott i-STAT chemistry analyzers S/N 424269 revealed QC was to be performed monthly, with each new lot, and with each new shipment. Monthly QC interval is considered to be not more than 31 days. 3. Review of the i-STAT QC from 10/7/22 to 3/12/24 revealed QC interval was not met when QC was performed on 11/22/22 when the previous QC was performed on 10/7 /22. The interval between these two test dates was 46 days. a. No documentation of the failed QC interval or CA were noted on the "QML" report. The document was reviewed by TC #1 12/21/22 for the 11/22/22 QC test date and noted as "QC ok, reviewed." 3. Review of the "POC IQCP Annual Assessment" for 2022 revealed: a. The document is dated 3/5/24. b. On page 1, Under Quality Control-Issues Identified- the entry is "None",

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with technical consultant #2, the laboratory failed to include the correct name and address of the laboratory where the professional component of the test was performed on the patient report at time of survey. Findings: 1. Review of selected patient test reports showed that the laboratory's correct name where the professional component of the test was performed was not present on the report. 2. Review of selected patient test reports showed that the laboratory's address where the professional component of the test was performed was not present on the report. 3. Interview with technical consultant #2 on 10/13/22 at 11:24 a.m. confirmed the laboratory failed to include the correct name and address of the laboratory where the professional component of the test was performed on the patient report. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --