Adventhealth Durand

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with the technical consultant, the laboratory director did not approve, sign and date four of four new Stago Satellite coagulation procedures prior to patient use. Findings include: 1. Review of verification of performance specifications on the Stago Satellite showed the go-live date for the analyzer was October 23, 2023. 2. Review of Stago Satellite coagulation testing procedures showed the following procedures were approved and signed by the laboratory director on October 30, 2023. Coagulation01 Stago Satellite Protime Coagulation02 Stago Satellite APTT Coagulation03 Stago Satellite Coag N and ABN Plus Controls Coagulation04 Stago Satellite Desorb 3. Interview with the technical consultant on April 24, 2024, at 3:00 PM confirmed the laboratory director did not approve, sign and date new coagulation procedures prior to patient use. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review of procedures, quality control (QC) records, patient reports, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- U.S. Food and Drug Administration (FDA) Clinical Laboratory Improvement Amendments (CLIA) classification database and Individualized Quality Control Plans (IQCP) and interview with the technical consultant, the laboratory did not perform QC each eight hours of patient testing on the Roche c501 D-Dimer test for two of forty- one patient tests between February 1, 2024 and April 24, 2024, and had not developed an IQCP. Findings include: 1. Review of the "Chem32 Tina-quant D-Dimer" procedure stated QC was performed "every 24 hours when test is in use and following calibration". 2. Review of QC records for D-dimer testing on the Roche c501 chemistry analyzer showed QC was run one time every 24 hours of patient testing from February 1, 2024, through April 24, 2024. 3. Review of patient testing performed between February 1, 2024, and April 24, 2024, showed the following: Patient 1: D-Dimer testing performed on March 7, 2024, at 1:42 AM. QC had been performed on March 6, 2024, at 8:26 AM and March 7, 2024, at 2:46 PM. Patient 2: D-Dimer testing performed on March 9, 2024, at 10:53 PM. QC had been performed on March 9, 2024, at 10:38 AM with no additional QC performed on March 9, 2024. 4. Review of the FDA CLIA classification database showed D-dimer testing on the Roche c501 chemistry analyzer is classified as a hematology test. 5. Review of the laboratory's IQCP's showed no evidence of an IQCP for the Roche c501 D-dimer test. 6. Interview with the technical consultant on April 25, 2024, at 11:00 AM confirmed the laboratory did not perform QC each eight hours of patient testing on the Roche c501 D-dimer test and had not developed an IQCP. -- 2 of 2 --

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of procedures and interview with the laboratory manager, the laboratory did not specify the required external quality control (QC) materials in two of six procedures reviewed. Findings include: 1. Review of six test procedures revealed the ePlex RP2 (Respiratory Panel 2) and the DAT (Direct Antiglobulin Test) procedures did not specify the external control material. A. The ePlex Respiratory Pathogen 2 procedure stated, "Positive and negative external controls should be tested with each new lot of reagents or monthly, whichever occurs first. Viral transport medium can be used as the negative control. Previously characterized positive samples or viral transport medium spiked with well characterized organisms can be used as the external positive control. External controls should be run in accordance with laboratory protocols and accrediting organizations, as applicable." The Quality Control Plan of the ePlex IQCP (Individualized Quality Control Plan) included, "External Controls / Perform each month and/or on each new lot of cartridges". Neither the procedure nor the IQCP specified what controls personnel should use. B. In the Quality Control section, the Direct Antiglobulin Testing procedure stated, "To Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- confirm the specificity and reactivity of the MTS Anti-IgG, -C3d Card, it is recommended that each lot be tested each day of use with known positive and negative samples. Reactivity must be present with the positive sample only. The anti- complement reactivity of the reagent can be assessed by using complement coated cells." The procedure did not show what controls the laboratory used and did not identify how the laboratory evaluated the anti-complement reactivity of the reagent. 2. Interview with the laboratory manager (staff A) on May 24, 2022 at 3:00 PM confirmed the ePlex and DAT procedures did not specify what controls the laboratory used to monitor the accuracy and precision of the complete analytic process for these two test systems. -- 2 of 2 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of immunoassay calibration verification records from the Roche Elecsys 411 analyzer and interview with the technical consultant, the laboratory did not perform calibration verification analysis that included the minimum and maximum reportable range for five of five analytes. Finding include: 1. Review of calibration verification records on the Roche Elecysis 411 analyzer showed the laboratory did not perform calibration verifications consistent with the reportable Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- range for Beta-Human Chorionic Gonadatropin (BHCG), Procalcitonin (PCT), Brain Natriuretic Peptide (BNP), Troponin-T High Sensitive (TnT-hs) and Vitamin D (25- OH) analytes: Test:Calibration Range:Reportable Range BHCG:4.84-8070mIU/mL: 0.1-10000mIU/mL PCT:0.5-81ng/mL:0.02-100ng/mL BNP:136-2557ng/L:5-35000ng /L TnT-hs:13.54-7140ng/L:6-10000ng/L 25-OH:18.89-79.73ng/mL:5-100ng/mL 2. Interview with the technical consultant on October 27, 2020 at 3:30 PM confirmed the calibration verification range did not cover the reportable range for five of five analytes. 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 surveyor review of frozen section reports and interview with the technical consultant, the preliminary frozen section report did not include all patient information for two of two patients reviewed for 2019 and 2020. Findings include: 1. Review of Patient one and Patient two showed the preliminary frozen section reports have a space to include the time results were reported to the surgeon and the report did not include the time the preliminary results were reported. Further review of Patient two showed the preliminary frozen section report did not include the date of specimen collection. 2. Interview with the technical consultant on October 28, 2020 at 11:03 AM, confirmed the preliminary frozen section reports for Patient one and Patient two do not have all the report information present. -- 2 of 2 --