Leon Medical Centers, Llc

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on September 21, 2022 for Leon Medical Centers. Leon Medical Centers is not in compliance with the Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2022, the laboratory did not have successful performance in proficiency testing for analytes in the specialty of hematology. Refer to D2131. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on September 21, 2022 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analytes, white blood cell (WBC), red blood cell (RBC), hemoglobin (HGB), hematocrit (HCT), mean cell volume (MCV), red cell distribution width (RDW), platelet count (PLT), and the white blood cell differential (WBC Diff) for two consecutive testing events in 2022. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing for analytes in the specialty of hematology. Findings include: On September 21, 2022 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analytes, white blood cell (WBC), red blood cell (RBC), hemoglobin (HGB), hematocrit (HCT), mean cell volume (MCV), red cell distribution width (RDW), platelet count (PLT), and the white blood cell differential (WBC Diff), as shown below. Event #1, 2022 WBC-0% RBC-0% HGB-0% HCT-0% MCV-0% RDW-0% PLT-0% WBC diff-0% Event #2, 2022 WBC-0% RBC-0% HGB- 0% HCT-0% MCV-0% RDW-0% PLT-0% WBC diff-0% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score in proficiency testing for analytes found in the specialty of hematology. Findings include: On September 21, 2022, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analytes, white blood cell (WBC), red blood cell (RBC), hemoglobin (HGB), hematocrit (HCT), mean cell volume (MCV), red cell distribution width (RDW), platelet count (PLT), and the white blood cell differential (WBC Diff), in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2131. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for analyte(s) found in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on September 21, 2022, on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two consecutive testing events for the analytes shown below. Event #1, 2022 WBC-0% RBC-0% HGB-0% HCT-0% MCV-0% RDW-0% PLT-0% WBC diff-0% Event #2, 2022 WBC-0% RBC-0% HGB-0% HCT-0% MCV-0% RDW-0% PLT-0% WBC diff-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted 03/15/2021, found the LEON MEDICAL CENTERS LLC clinical laboratory was not compliance with 42 CFR Part 493, Requirements for Laboratories. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to label quality control vials currently in use with an open date and new expiration date. Findings include: Examination of the EIGHT-CHECK3WP XTRA control levels in use for the Sysmex poch-100i analyzer on 3/16/2021 at 9:30 AM showed the quality control vials for level 1, 2 and 3 did not have an open date and new expiration date. Review of the PocH 100i Quality Control Assessment policy # 7009 of 10/04/2016, revealed on page 2 of 6, on section D) EIGHT-CHECK3WP XTRA Control Material revealed: 1.Storage and shelf life EIGHT-CHECK3WP XTRA is to be stored as packaged at 2-8 C before and after opening. After opening the vial is stable for 14 days if returned to the refrigerator promptly after use. During an interview on 3/15 /2021 at 9:45 AM, testing personnel 1 stated the open date and new expiration date were not labeled on the control vials. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform quality control lot to lot comparisons from 6/12/2019 to 3/15/2021 for hematology controls. Finding include: Review of the PocH 100i Quality Control Assessment policy # 7009 of 10/04 /2016, on page 4 of 6 section G) Starting a New Lot of Controls revealed: Parallel test new controls by analyzing the three levels of control, a minimum of twice a day for 5 days, prior to expiration of the previous lot. After a minimum of 10 data points are accumulated, enter the new targets using the mean of the analyzed points. Review of Quality Control records showed there was no lot to comparison of the hematology controls. During an interview on 3/15/2021 at 11:00 AM, the Testing Personnel 1 stated the laboratory did not perform lot to lot comparisons of hematology controls. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Leon Medical Centers Inc on 6/11/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review of American Proficiency Institute (API) proficiency testing records and interview with Testing Person #1, the laboratory failed to score at least 80 % on White Blood cell Diferrential (WBC DIFF) for 1 (2nd event of 2018) out of 6 events for Hematology reviewed. Findings include: Review of API proficiency records revealed a score of 33 % for WBC DIFF in the 2nd event of 2018. During an interview on 06/11/2019 at 10:30 AM, the TP # 1 confirmed the failed proficiency testing score. 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 --