Rigby Community Care

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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded results from the American Proficiency Institute (API), and a telephone interview with the laboratory supervisor on 02/17/2026 the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2025 in the specialty of hematology for automated white blood cell (WBC) differentiation examination. See D2130. D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) (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 a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Proficiency Institute (API) and a telephone interview with the laboratory supervisor on 02/17/2026, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2025 in the specialty of hematology for the automated white blood cell (WBC) differential consisting of failures in the analyte components: basophils, eosinophils, monocytes and neutrophils. The findings include: 1. A PT desk review of Report 155D and graded PT results from API identified that the laboratory failed to achieve overall satisfactory scores for event two (2) and event three (3) in 2025 for the specialty of hematology for the analyte automated WBC differential consisting of failures in analyte components, basophils, eosinophils, monocytes and neutrophils. . Analyte Event Score WBC Differential 2025-2 20% Basophils 2025-2 20% Eosinophils 2025-2 0% Monocytes 2025-2 60% Neutrophils 2025-2 0% WBC Differential 2025-3 28% Basophils 2025-3 0% Eosinophils 2025-3 0% Monocytes 2025-3 60% Neutrophils 2025-3 0% 2. A telephone interview with the laboratory supervisor on 02/17/2026 at 4:19 pm confirmed the above findings. 3. The laboratory reports performing 3,000 Automated WBC Differentials annually. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of training and competency records, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with testing personnel 1 (TP1) on 12/03/2020, the laboratory failed to follow written policies and procedures to assess employee competency. The findings include: 1. The CMS-209 identifies six (6) testing personnel performing moderate complexity testing. A training and competency record review revealed that two (2) of the six (6) testing personnel were hired since the previous inspection, 6/27/2018, and did not have documentation of initial training and competency for complete blood count testing (CBC). Testing person start date TP2 8/2018 TP3 5/2020 2. An interview with testing personnel (TP1) on 12/03/2020 at 9:10 am, confirmed that initial training and competency for two (2) of the six (6) testing personnel for CBC testing had not been documented. 3. The laboratory reports performing 2200 CBC tests annually. 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 --