Russell Family Medical Center

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 10/07/2025 and concluded on 10/07/2025. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to ensure they did not use capillary blood collection devices that were beyond the manufacturer's expiration date for Complete Blood Count (CBC) testing. This was noted for 37 out of 61 collection devices observed. Findings included: During an observation on 10/07/2025 at 9:20 AM, the phlebotomy area near the laboratory contained Microtainer EDTA (ethylenediaminetetraacetic acid) blood collection tubes used for CBC testing; 6 of 30 total tubes examined had an expiration date of 07/31/2025. The supplies also contained unidentified EDTA capillary blood collection tubes used for CBC testing; 31 of 31 tubes had expired and revealed the following expiration dates: - One tube had an expiration date of 01/31/2024. - 17 tubes had an expiration date of 01/31/2025. - Eight tubes had an expiration date of 03/31/2025. - Five tubes had an expiration date of 08/31/2025. During an interview on 10/07/2025 at 9:45 AM, the Pediatric Regional Director (PRD) stated the Microtainer EDTA blood collection tubes were on back- order and the supply found in the phlebotomy area near the laboratory was the only stock on hand. 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: Based on desk review of Hematology proficiency testing results from the American Academy of Family Physicians (AAFP) proficiency testing agency on 06/01/2020, the laboratory failed to successfully participate in the White Blood Cell Differential certified analyte in two consecutive testing events. See D2121 and D2130 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Hematology proficiency testing results from American Academy of Family Physicians (AAFP) proficiency testing agency on 06/01/2020, the laboratory failed to attain a score of at least 80 (eighty) percent for a satisfactory performance for the White Blood Cell Differential in two consecutive testing events. Findings include: 1. The laboratory scored forty (40) percent in the third testing event of 2019. 2. The laboratory scored forty-seven (47) percent in the first testing event of 2020. D2130 HEMATOLOGY CFR(s): 493.851(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 desk review of Hematology proficiency test results from the American Academy of Family Physicians (AAFP) proficiency testing agency on 06/01/2020, the laboratory failed to successfully achieve satisfactory performance for White Blood Cell Differential in two consecutive testing events. Findings include: 1. The laboratory scored forty (40) percent in the third testing event of 2019. 2. The laboratory scored forty-seven (47) percent in the first testing event of 2020. -- 2 of 2 --