Cleveland Family Health Care Center

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 laboratory observation, review of final patient test report, review of test system records, and staff interview, the laboratory failed to establish reference ranges for patient population type "U" for complete blood count (CBC) patient testing on the date of the survey (07.01.2026). The findings include: 1. Observation of the laboratory on 07.01.2026 at 8:30 a.m. revealed a Sysmex XP300 (serial number C6323) analyzer used for CBC patient testing. 2. Review of a final patient test report (patient 94346) revealed that the laboratory included this patient in the population "U." 3. Review of test system records for CBC testing revealed no established reference ranges (normal values) for CBC for the patient population titled "U," on the date of the survey (07.01.2026). 4. An interview on 07.01.2026 at 11:45 a.m. with the Chief Financial Officer and the Quality Manager confirmed the above survey findings. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. 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 -- This STANDARD is not met as evidenced by: Based on laboratory observation, a review of final patient test reports, and staff interviews, the laboratory failed to include reference ranges for one of six final patient test reports for complete blood count (CBC) patient testing on the date of the survey (07.01.2026). The findings include: 1. Observation of the laboratory on 07.01.2026 at 8:30 a.m. revealed a Sysmex XP300 (serial number C6323) analyzer used for CBC patient testing. 2. A review of final patient test reports for CBC revealed that one (patient 94346, population type "U," reported on 06.30.2026) of six final test reports reviewed did not include reference ranges for CBC. 3. An interview on 07.01.2026 at 11:45 a.m. with the Chief Financial Officer and the Quality Manager confirmed the above survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D5783

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: ================================== Hematology: The laboratory failed to maintain satisfactory participation in two out of two events for the automated white blood cell (WBC) differential, resulting in the first unsuccessful proficiency testing (PT) occurrence for the automated WBC differential analyte (Refer to D2128). ================================== 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 -- 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 a desk review of the CMS CASPER Report 0155D and the laboratory's 2018 Proficiency Testing (PT) records, the laboratory failed to maintain satisfactory performance for the automated WBC (White Blood Cell) Differential in the 2nd and 3rd events of 2018, resulting in the first unsuccessful occurrence. The findings include: 1. Review of the CMS 0155D report revealed the 2018 automated WBC Diff event two score was 67% and event three score was 47%. 2. Review of the laboratory's 2018 PT records revealed event two had unacceptable scores for Lymphocytes, resulting in a 0% grade and event score of 67%. 3. Review of the laboratory's 2018 PT records revealed event three had unacceptable scores for Granulocytes resulting in a grade of 20% and unacceptable scores for Lymphocytes resulting in a grade of 40% for a total event score of 47% for the WBC Differential, resulting in the first unsuccessful PT occurrence. ==================================== -- 2 of 2 --