Marion Diagnostic Center L L C

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, lack of documentation, and interview with the laboratory representative; the laboratory failed to ensure attestation statements were completed for six of six PT events for Chem 8+ testing on the i- STAT analyzer in 2022 and 2023. Findings Include: 1. Review of the American Proficiency Institute (API) PT records for 2022 and 2023 revealed a lack of attestation statements for six of six routine chemistry events in 2022 and 2023, including the eight regulated analytes listed below. Regulated Chem 8+ analytes: Chloride, Creatinine, Glucose, Potassium, Sodium, Urea Nitrogen (BUN), Hematocrit, and Hemoglobin 2. On survey date 11/29/2023, at 12:59 pm, an interview with the laboratory representative confirmed these findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory records, lack of documentation, and interview with the laboratory representative; the laboratory failed to have a competency policy Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- /procedure in place to assess employee competency on the i-STAT analyzer used for Chem 8+ cartridges (testing Sodium, Potassium, Chloride, Glucose, Calcium, Total Carbon Dioxide, BUN, Creatinine, Hematocrit, and calculated Anion Gap and Hemoglobin) as required per 493.1235. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the lack of a competency assessment policy/procedure in place as required per 493.1235. 2. On survey date 11- 29-2023, at 9:42 am, the laboratory representative confirmed the laboratory failed to have a competency policy/procedure in place to assess employee competency. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with testing personnel (TP) #2; the laboratory failed to ensure accuracy of hematology analytes not evaluated by the proficiency testing (PT) provider for 3 of 3 PT events in 2019. Findings Include: 1. Hematology proficiency testing records were reviewed for 2019. 2. Review of American Proficiency Institute (API) comparative evaluation summaries for PT events 1 through 3 of 2019 revealed the following un-graded proficiency testing samples: PT Event Analyte Sample Performance 2019 Event 1 Platelet Count QBC- 04 Not Graded 2019 Event 1 White Cell Count QBC-01 Not Graded 2019 Event 1 White Cell Count QBC-02 Not Graded 2019 Event 1 White Cell Count QBC-03 Not Graded 2019 Event 1 White Cell Count QBC-04 Not Graded 2019 Event 1 White Cell Count QBC-05 Not Graded 2019 Event 2 White Cell Count QBC-06 Not Graded 2019 Event 2 White Cell Count QBC-07 Not Graded 2019 Event 2 White Cell Count QBC-08 Not Graded 2019 Event 2 White Cell Count QBC-09 Not Graded 2019 Event 2 White Cell Count QBC-10 Not Graded 2019 Event 3 White Cell Count QBC-11 Not Graded 2019 Event 3 White Cell Count QBC-13 Not Graded 2019 Event 3 White Cell Count QBC-14 Not Graded 2019 Event 3 White Cell Count QBC-15 Not Graded 3. Review of API PT records found no documented review of the ungraded proficiency testing analytes which resulted in the inaccurate reporting of PT performance for white blood cell counts in events 1 through 3 of 2019 and platelet counts in event 1 of 2019. 4. On survey date 2-25-2020, at 5:30 pm, TP#2 confirmed the above findings. 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 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --