Renal Associates, Pc

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 proficiency testing (PT) record review and interview with the laboratory supervisor, the laboratory failed to achieve successful participation for the albumin test method. Unsatisfactory results had been received in two of three PT events (American Proficiency Institute 2023 Chemistry Core 2nd Event and 2023 Chemistry Core 3rd Event) resulting in unsuccessful PT participation. Refer to D2087 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 -- 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 review of the CASPER proficiency testing (PT) reports 153D and 155D, the laboratory's American Proficiency Institute (API) PT reports and interview with the laboratory supervisor, the laboratory failed to achieve a satisfactory score of 80% or above for the albumin test method for two of three events (API 2023 Chemistry Core 2nd Event and 2023 Chemistry Core 3rd Event). Findings include: 1. Review of the 10 /27/2023 CASPER Unsuccessful PT Report 153D revealed the laboratory received unsatisfactory scores (less than 80%) for the albumin test method in each of the two events identified above. Review of the 10/27/2023 CASPER Individual Laboratory Profile PT report 155D and API PT 2023 Chemistry Core 2nd and 2023 Chemistry Core 3rd event evaluation reports revealed scores of 20% and 20% for the albumin test method for each event. Review of the individual API albumin test method scores for the two API PT events revealed: a. 2023 Chemistry Core 2nd Event albumin results: *CH-06 was 3.0, the acceptable range was 2.3-2.9 grams/deciliter (g/dL). *CH-07 was 4.7, the acceptable range was 3.6-4.5 g/dL. *CH-09 was 5.5, the acceptable range was 4.3-5.4 g/dL. *CH-10 was 4.2, the acceptable range was 3.2-4.1 g/dL. b. 2023 Chemistry Core 3rd Event albumin results: *CH-11 was 5.4, the acceptable range was 4.3-5.3 g/dL. *CH-13 was 4.9, the acceptable range was 3.7-4.7 g/dL. *CH-14 was 4.7, the acceptable range was 3.4-4.2 g/dL. *CH-15 was 3.9. the acceptable range was 2.9-3.7 g/dL. Interview on 10/27/23 with the laboratory supervisor revealed the laboratory had been aware of the failures. The initial failures had been investigated. It was determined that both failures were due to a shift after calibration of the reagent. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 12/8/21. The Renal Associates laboratory was found not in compliance with the following requirements: D2009, D2015, D5215, D6018, and D6032. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure the laboratory director and testing personnel had signed five of eight 2021 American Proficiency Institute (API) proficiency testing (PT) attestation statements (Hematology /Coagulation 1st event, Chemistry Core 1st, 2nd, and 3rd events, and Chemistry - Miscellaneous 1st event) that attested PT samples had been tested in the same manner as patient specimens. Findings include: 1. Review on 12/8/21 of 2021 API PT events revealed: *The Hematology/Coagulation 1st PT event attestation statement had not been signed by the laboratory director. *The Chemistry Core 1st PT event attestation statement had not been signed by the laboratory personnel who had performed the testing. *The Chemistry Core 2nd PT event attestation statement had not been signed by the laboratory director or the laboratory personnel who had performed the testing. *The Chemistry Core 3rd PT event attestation statement had not been signed by the laboratory director or the laboratory personnel who had performed the testing. *The Chemistry - Miscellaneous 1st event attestation statement had not been signed by the laboratory director. Review on 12/8/21 of the laboratory's Proficiency Testing policy, dated 2/1/17, revealed: *"The technical consultant/designated personnel will review the results of each proficiency test before the results are submitted." *"All PT records Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- and testing must be kept for a period of 2 years." Interview on 12/8/21 at 11:50 a.m. with testing personnel A revealed: *She was not aware the "not graded" results had not been reviewed. *The testing had been performed before her being hired by the clinic in September 2021. *The testing had been performed by an employee who was no longer employed by the clinic. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to maintain a copy of required documentation related to the processing of seven of eight 2021 American Proficiency Testing Institute (API) proficiency testing (PT) events reviewed (Hematology/Coagulation 2nd and 3rd events; Chemistry Core 1st, 2nd, and 3rd events; and Chemistry - Miscellaneous 1st and 2nd events). This documentation would ensure the the results submitted for evaluation had been the results obtained by the laboratory processing the PT samples. Findings Include: 1. Review on 12/8/21 of the laboratory's 2021 API PT event records revealed: *The laboratory subscribed to PT events through the API. *PT specimens were processed and the results submitted via the company's website upon completion of testing. a. The laboratory had not retained copies of analyzer printouts documenting the results obtained from processing the PT samples for the following events: -Hematology/Coagulation 2nd testing event -Hematology/Coagulation 3rd testing event -Chemistry Core 1st testing event -Chemistry Core 3rd testing event b. The laboratory had not retained copies of results submitted electronically for evaluation for the following events: -Hematology /Coagulation 2nd testing event -Hematology/Coagulation 3rd testing event -Chemistry Core 1st testing event -Chemistry Core 2nd testing event -Chemistry Core 3rd testing event -Chemistry - Miscellaneous 1st event -Chemistry - Miscellaneous 2nd event Review on 12/8/21 of the Proficiency Testing policy, dated 2/1/17, revealed, "All PT records and testing must be kept for a period of 2 years." Interview on 12/8/21 at 11: 50 a.m. with laboratory personnel A revealed: *She was not aware the laboratory had not maintained the necessary documentation of PT processing. *The testing had been performed before her being hired by the clinic in September 2021. *The testing had been performed by an employee who was no longer employed by the clinic. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required -- 2 of 4 -- for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to review proficiency testing (PT) results to ensure the accuracy of five of seven results not graded as acceptable 2021 American Proficiency Institute (API) PT samples reviewed (API 2021 Chemistry Core 1st and second events, Chemistry - Miscellaneous 1st event). Findings include: 1. Review on 12/8/21 of the 2021 API PT records revealed: * The evaluation and