Riverview Family Medicine And Urgent Care

Summary Statement of Deficiencies D0000 An announced onsite CLIA recertification survey was conducted on April 7, 2026, at the laboratory of Riverview Family Medicine and Urgent Care of Rock Hill by the South Carolina Department Public Health (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with Medicare condition 42 CFR Part 493, CLIA requirements for laboratories. The following is a list of deficiencies cited as a result of the April 7, 2026, recertification survey. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on records review, lack of documentation, and staff interview, the laboraory failed to have documentation of high school diploma or equivalent for 13 of 20 testing personnel (TP) listed on the CMS 209 form for the two years reviewed (2024 and 2025) Findings included: 1. Records review of CMS 209 form reveals 20 testing personnel (TP) 2. Surveyor requested and the laboratory failed to provde high school 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 -- graduate or equivalent documentation for 13 out of 20 TPs. a. TP1 h. TP9 b. TP3 i. TP10 c. TP4 j. TP14 d. TP5 k. TP16 e. TP6 l. TP19 f. TP7 m. TP20 g. TP8 No TP qualification information was available on the day of the inspection. 3. In an interview on April 7, 2026 at 12:30pm in the laboratory office with TP2, the findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An offsite Proficiency Testing Desk Review survey was conducted for Riverview Family Medicine and Urgent Care on October 8, 2025. The facility was found to be out of compliance with the conditions of 42 CFR Part 493, CLIA Laboratory Requirements. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 desk review of proficiency testing (PT) records from the Certification and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Survey Provider Enhanced Reporting (CASPER) 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the analyte Red Blood Cells (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell Count (WBC), Mean Corpuscular Volume (MCV), Platelets (PLT). Refer D2130, D2131 D2130 HEMATOLOGY 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 desk review of CASPER 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) 2024 and 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events in the subspecialty of Hematology for the analyte Red Blood Cells (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell Count (WBC), Mean Corpuscular Volume (MCV), Platelets (PLT). Findings included: 1. A review of the CASPER 0155 report revealed the following results: Hematology 2024-3rd Event the laboratory received unsatisfactory score of 0% for: Hematology Red Blood Cells (RBC) Hematocrit (HCT) Hemoglobin (HGB) White Blood Cells (WBC) Mean Corpuscular Volume (MCV) Platelets (PLT) Hematology 2025-2nd Event the laboratory received unsatisfactory score of 0% for: Hematology Red Blood Cells (RBC) Hematocrit (HCT) Hemoglobin (HGB) White Blood Cells (WBC) Mean Corpuscular Volume (MCV) Platelets (PLT) 2. A review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records confirmed the laboratory received the above results. D2131 HEMATOLOGY CFR(s): 493.851(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing 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 desk review of CASPER 0155 report and WSLH proficiency testing 2024 and 2025 records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the specialty of Hematology for two out of three consecutive testing events. Findings included: 1. A review of the CASPER 0155 report revealed the following results: Hematology 2024-3rd Event the laboratory received an unsatisfactory score of 0% for overall Hematology. Hematology 2025-2nd Event the laboratory received an unsatisfactory score of 0% for overall Hematology. 2. A review of the WSLH proficiency testing records confirmed the laboratory received the above results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR -- 2 of 3 -- CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) 2024 and 2025 records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130 and D2131. -- 3 of 3 --