Arete Family Care, Llc

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 an off-site desk review of the laboratory's 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the laboratory director, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analytes White Blood Cell (WBC) Differential, Red Blood Cell (RBC) Count, Hematocrit (HCT), Hemoglobin, (HGB), White Blood Cell Count, Platelets, and the specialty Hematology in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. Refer to D2130 and D2131. 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 -- 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 an off-site desk review of the laboratory's 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the laboratory director, it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the analytes White Blood Cell (WBC) Differential, Red Blood Cell (RBC) Count, Hematocrit (HCT), Hemoglobin, (HGB), White Blood Cell Count, Platelets, and the specialty Hematology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2024 API PT records revealed analyte scores of less than eighty percent for the following Hematology events: a. WBC Differential: 2024-1 = 0%, 2024-3 = 0% b. RBC Count: 2024-1 = 0%, 2024-3 = 60% c. Hematocrit: 2024-1 = 0%, 2024-3 = 60% d. Hemoglobin: 2024-1 = 0%, 2024-3 = 60% e. WBC Count: 2024-1 = 0%, 2024-3 = 60% f. Platelets: 2024-1 = 0%, 2024-3 = 60% 2. In an email with the laboratory director on January 7, 2025, it was confirmed that the laboratory was unsuccessful in the PT events listed above. 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 an off-site desk review of the laboratory's 2024 American Proficiency Institute (API) proficiency testing (PT) records and a phone interview with the laboratory director, it was determined the laboratory failed to attain a score of at least eighty (80) percent of overall testing event scores for the specialty Hematology in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2024 API PT records revealed Hematology scores of less than eighty percent for the following events: a. 2024-1 Hematology = 0% b. 2024-3 Hematology = 50% 2. In an email with the laboratory director on January 7, 2025, it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a lack of documentation and an interview with the laboratory director, the laboratory failed to have a written procedure for qualitative semen analysis. Findings include: 1. A request was made to review the procedure for qualitative semen analysis and documentation could not be provided. 2. An on-site interview conducted with the laboratory director on 8/26/2024 at 13:30 PM confirmed the laboratory did not have written procedure for qualitative semen analysis. 3. The laboratory reports performing less than five qualitative semen analysis annually. 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: 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 -- Based on a lack of documentation and an interview with the laboratory director, the laboratory failed to verify the performance specifications for accuracy, precision, reportable range, and reference range for urine microalbumin on the Alere Afinion 2 analyzer received on 7/6/2023, prior to reporting patient results. Findings include: 1. A request was made to review the verification of performance specifications for urine microalbumin on the Alere Afinion 2 analyzer, and documentation could not be provided. 2. The laboratory started testing patients on 7/8/2024. 3. An on-site interview conducted with the laboratory director on 8/26/2024 at 13:30 PM confirmed the laboratory did not have the verification studies for accuracy, precision, reportable range, and reference range for urine microalbumin on the Alere Afinion 2 analyzer. 4. The laboratory reports performing approximately 1650 microalbumin test annually. -- 2 of 2 --

Summary Statement of Deficiencies 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 have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of testing personnel records and an interview with the laboratory manager, the laboratory did not ensure one laboratory testing person met the educational qualifications for performing moderate complexity testing. Findings include: 1. A review of testing personnel diplomas and transcripts revealed that 1 of the 4 testing persons listed on the CMS 209 as testing personnel (TP) did not meet the educational qualifications for performing moderate complexity testing. 2. A review of TP #2's educational records and transcript revealed TP #2 did not have a diploma or transcript from an accredited institution, and did not have an evaluation of his credentials by a nationally recognized organization to determine the equivalency of his education to an education obtained in the United States. 3. The laboratory manager confirmed these findings in an interview on 9/13/2022 at 1:15 pm. 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 --