El Dorado Clinic

Summary Statement of Deficiencies 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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system and the Wisconsin State Laboratory of Hygiene (WSLH) PT summary reports, the laboratory failed to successfully participate in the CMS approved PT 2026 program under the specialty of Routine Hematology, for two consecutive testing events. Refer D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of PT scores from the provider WSLH for Hematology, and phone interview, the laboratory failed to achieve an acceptable score of 80% or higher for two consecutive testing events for the regulated analyte 0770 - WBC Differential Findings: 1. Review of WSLH PT scores for 2026 revealed the following performance scores for 0770 - WBC Differential a. First testing event 2026 revealed a score of 0%. b. Second testing event 2026 revealed a score of 0%. 2. Phone interview with testing personnel on 9/8/26 at 2:30 p.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two consecutive testing events for the regulated analyte 0770 - WBC Differential -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from Wisconsin State Laboratory of Hygiene (WSLH), lack of evaluation documentation, and interview with the technical consultant (TC), the laboratory failed to evaluate proficiency testing results for three of six testing events in 2023. Findings: 1. The surveyor requested evaluation documentation for PT results from WSLH. No evaluation documentation was provided at the time of survey for the following events: a. 2023 Hematology 2 b. 2023 Misc QA POC 2 c. 2023 Chem/Endo/Tx 3 2. Interview with the TC on 2/15/24 at 3 p.m. confirmed, the laboratory failed to evaluate proficiency testing results for three of six testing events in 2023. 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 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: A review of calibration verification records for the Abbott Cell-Dyn Emerald analyzer, and interview with staff revealed that the laboratory failed to perform calibration verification once every six months. One of two calibration verifications were performed in 2019 on the Cell-Dyn Emerald analyzer. Finding were as follows 1. Review of the Abbott Cell-Dyn Emerald verification documentation revealed the laboratory failed to perform calibration verification at least once every six months. 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 -- The laboratory performed a calibration verification on May 2, 2019 but failed to perform the calibration verification that was due in November 2019. A calibration verification for March 11,2020 was performed. 2. Interview with the technical consultant #2 confirmed that only one of the two required calibration verification was performed in 2019 for the Abbott Cell-Dyn Emerald analyzer. -- 2 of 2 --