Lexington Regional Health Center

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on surveyor review of quality control records and interview with the laboratory manager the laboratory failed to perform quality control (QC) each day of patient testing on the following tests: I. chlamydia/gonorrhea testing from 10/18/2023 - 4/17 /2025 II. group B strep testing from 5/24/2021 - 4/17/2025 III. clostridium difficile testing from 11/6/2024 - 4/17/2025 IV. clostridium difficile toxin testing from 11/6 /2024 - 4/17/2025 1. Review of quality control records for chlamydia/gonorrhea testing, group B strep testing, clostridium difficile testing, and clostridium difficile toxin testing revealed QC was performed monthly. 2. Interview with the laboratory manager on 4/17/2025 at 11:15 AM, confirmed the laboratory did not perform QC each day of patient testing for chlamydia/gonorrhea testing, group B strep testing, clostridium difficile testing, and clostridium difficile toxin testing. 3. Interview with the laboratory director on 4/17/2025 at 11:15 AM, confirmed the laboratory did not have an Individualized Quality Control Plan (IQCP) in place for chlamydia/gonorrhea testing, group B strep testing, clostridium difficile testing, and clostridium difficile toxin testing. 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 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of new instrumentation logs, lack of documentation, and interview with the laboratory supervisor the laboratory failed to verify precision for a new sedimentation rate instrument. 1. Review of new instrumentation revealed the laboratory started patient testing on January 2021 with a new sedimentation rate instrument. The laboratory performed two hundred and twenty seven sedimentation rate tests to date with the new instrument. 2. Review of the validation of performance specifications for the new sedimentation rate instrument revealed no run to run precision studies had been performed. 3. Interview with the laboratory supervisor on 7 /15/2021 at 3:37 PM confirmed run to run precision was not performed prior to patient testing. 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 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: The laboratory failed to achieve satisfactory scores for the endocrinology analyte, HCG, for the second event 2019 and third event 2019. See D2107. This results in the unsuccessful performance in proficiency testing for this analyte. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2019, this laboratory had unsatisfactory performance for the analyte HCG for the second event 2019 (score 60%) and the third event 2019 (score 60%). -- 2 of 2 --