Shands Jacksonville Medical Ctr Dba

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at UF Health Oncology Orange Park on 6/28/2021. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. . D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and interview, the facility failed to test proficiency samples the same number of times that it routinely tests patient samples for the 1st and 2nd Hematology/Coagulation testing events in 2020 and the 1st Hematology/ Coagulation testing event of 2021. Findings include: Record review revealed American Proficiency Institute samples were run twice for tests: Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, White Cell Count, Mean Corpuscular Volume, Mean Corpuscular Hemoglobin, Mean Corpuscular Hemoglobin Concentration, Red Cell Distribution Width, Neutrophil, Lymphocyte, Monocyte, Eosinophil, and Basophil. For the 1st testing event of 2020, samples were run on 3/17/2020 as follows: XE-01 was run at 07:28 and 07:36 XE-02 was run at 07:29 and 07:37 XE-03 was run at 07: 30 and 07:38 XE-04 was run at 07:31 and 07:39 XE-05 was run at 07:32 and 07:40 For the 2nd testing event of 2020, samples were run on 7/10/2020 as follows: XE-06 was run at 14:31 and 14:39 XE-07 was run at 14:32 and 14:40 XE-08 was run at 14: 33 and 14:41 XE-09 was run at 14:34 and 14:42 XE-10 was run at 14:36 and 14:43 For the 1st testing event of 2021, samples were run on 3/11/2021 as follows: XE-01 was run at 11:18 and 15:48 XE-02 was run at 11:20 and 15:49 XE-03 was run at 11: 21 and 15:50 XE-04 was run at 11:22 and 15:51 XE-05 was run at 11:23 and 15:53 Interview with the Technical Consultant on 6/28/2021 at 12:15 confirmed testing personnel had run proficiency samples multiple times for the 1st Hematology/ 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 -- Coagulation testing event of 2021, and the 1st and 2nd Hematology/ Coagulation testing events in 2020. . D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview, the facility failed to sign and date proficiency testing attestation forms for two out of five events reviewed (2019 - 2021). Findings include: Record review revealed the American Proficiency Institute, 2020 Hematology /Coagulation 1st and 2nd testing events, attestation forms were not signed and dated by testing personnel and the lab director. Interview with the Technical Consultant on 6 /28/2021 at 12:15 confirmed attestation forms were not signed and dated by testing personnel and the lab director. -- 2 of 2 --

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, UF Health Oncology Orange Park was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. 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 record review and staff interview, the facility failed to perform the calibration verification at least once every 6 months for the Sysmex XS-1000 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 -- hematology analyzer. Findings include: The record review on 7/30/19 of the calibration documentation for the Sysmex XS-1000 hematology analyzer showed calibration was performed 1/12/17, 9/13/17, 6/25/18, 12/19/18, and 2/21/19. The interview with the Technical Consultant on 7/30/19 at 9:26am confirmed calibration had not been performed every 6 months as manufacturer instructions require due to the service contract expiring. -- 2 of 2 --