Renal Consultants Pllc

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Renal Consultants PLLC on May 14, 2025, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific noncompliance, cited as deficiencies, are explained below. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 A proficiency testing (PT) desk review was performed for Renal Consultants PLLC on September 8, 2023, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations with the American Proficiency Institute (API) were reviewed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. 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 review of the proficiency testing (PT) records from the American 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 -- Proficiency Institute (API) and the CMS CASPER 153D Unsuccessful PT Report, the laboratory failed to successfully participate in PT for the analyte #0765 CELL ID or WBC DIFF for two of three consecutive events. Findings: 1. CMS CASPER 153D report revealed the following unsuccessful participation in two of three consecutive events for analyte #0765 CELL ID or WBC DIFF: 28% Event 3 2022 40% Event 2 2023 2. API evaluation summary confirmed the unsatisfactory scores of 28% and 40% in two of three consecutive events for the analyte #0765 WBC DIFF and the unsuccessful performance of the laboratory. D2131 HEMATOLOGY CFR(s): 493.851(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 review of the proficiency testing (PT) records from the American Proficiency Institute (API) and CMS CASPER 155D Individual Laboratory Profile (PT Report), the laboratory produced unsatisfactory results for analyte #0765 WBC DIFF for two of three consecutive testing events. Findings: 1. Review of API evaluation scores and CASPER 155D identified the following unsatisfactory scores for analyte #0765 WBC DIFF: 28% Event 3 2022 40% Event 2 2023 -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted for Renal Consultants PLLC on June 7, 2023, by the West Virginia Office of Laboratory Services. The laboratory was surveyed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. 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: Based on record review, written policies and procedures (P&P), and interview the laboratory failed to document the (ii) verification of normal value ranges for all 31 analytes on the Vitros 5600 analyzer before being put into use for patient testing. Findings: 1. Review of the verification of performance standards records for the Vitros 5600 analyzer (PIU 4/1/23) revealed a lack of documentation for the evaluation of the manufacturer's normal values or the modification of normal value ranges for laboratory patient population based on published data. 2. Review of P&P identified "Reference Ranges- Normal Values" which states evaluation of normal ranges must take place when a change of analytic methodology occurs and describes the process 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 -- required. 3. No documentation of the evaluation of normal ranges for the 31 analytes on the Vitros 5600 could be located. 4. An interview with the laboratory manager, 6/7 /23 at approximately 9:00 AM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Renal Consultants PLLC on April 26, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to achieve a satisfactory score for analyte 0585 TSH in 1 of 3 American Proficiency Institute (API) 2020 testing events. Findings: 1. API record review identified a score of 60% for analyte 0585 TSH in the 2nd testing event of 2020. 2. CASPER 155D Report confirmed the API score of 60%. 3. The laboratory manager confirmed the finding 4/26/2021 at approximately 11:10 AM. 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 --