Eastern Nephrology Associates

Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, the absence of personnel competency records, interview with technical consultant (TC), and interview with testing personnel (TP #1) 04/03/24, the laboratory director (LD) failed to ensure policies and procedures were followed for performing annual competency evaluations for 1 of 2 TP (TP #1) for 2020, 2021, 2022, and 2023. Findings: Review of "Personnel Training & Competency Assessment" policy/procedure revealed "b. After the first year of employment, competency assessment will be done and documented annually." Review of "Laboratory Director Responsibilities" policy/procedure, revealed "Ensure that policies and procedures are established for monitoring individuals...verify that they maintain competency to: - process specimens, - perform test procedure, and - report test results promptly and proficiently." No competency evaluation records available to review for TP #1 for 2020, 2021, 2022 and 2023. Interview with TC at approximately 3:57 p.m. confirmed no competency evaluation records availabe for TP #1 for 2020, 2021, 2022, and 2023. TC stated she took over October 02, 2023, and she could not find competency documentation for TP #1 for 2020, 2021, 2022 and 2023. 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 -- TC stated the prior TC either didn't do it or lost the paperwork. Interview with TP #1 at approximately 3:58 p.m. confirmed prior TC did not complete her competency evaluation documentation for 2020, 2021, 2022, and 2023. During interview at approximately 4:20 pm, TP #1 provided 2020 and 2021 competency records for review by the surveyor. The records were not signed by TP #1, the TC, or the LD to indicate review and approval. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of 2020 and 2021 proficiency testing (PT) records, and interview with technical consultant (TC) 3/17/22, the laboratory failed to retain documentation of the processing, reporting and review of PT samples and results for the third hematology event in 2020. Findings: Review of 2020 PT records revealed no documentation of the third hematology PT event in 2020. Review of 2021 PT records revealed the laboratory participated and received a score for the third hematology PT event in 2020. Interview with TC at approximately 11:30 a.m. on 3/17/22, confirmed the third PT event for hematology had been completed and documentation had been reviewed online. She also confirmed the laboratory did not know where the documentation was located. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including 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 -- instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2019, 2020 and 2021 package inserts for TOSOH quality control (QC) reagent and interview with TC 3/17/22, the laboratory failed to retain documentation of lot numbers, expiration dates and assay ranges determined by the manufacturer for the TOSOH QC reagent used for parathyroid hormone (PTH) testing. Findings: Review of 2019, 2020 and 2021 TOSOH QC reagent package inserts revealed the package inserts failed to include the lot numbers, the expiration dates and the assay ranges of Level I and Level II QC determined by the manufacturer. For example: One package insert had the assay ranges written on the package insert but did not include the lot numbers or the expiration date of the QC reagent. Interview with TC at approximately 2:00 p.m. confirmed the package inserts failed to include lot numbers, expiration dates and the assay ranges determined by the manufacturer. She stated they were on the box top of the TOSOH QC reagent. She also confirmed the laboratory was not retaining the box tops of the reagents used. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API (American Proficiency Institute) proficiency testing results 9/10/20, the laboratory failed to successfully participate in proficiency testing for WBC (white blood cell) Differential in two consecutive testing events. See the deficiency cited at D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API (American Proficiency Institute) proficiency testing results 9/10/20, the laboratory failed to successfully participate in proficiency testing for WBC(white blood cell ) Differential in two consecutive events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 40% for Granulocytes and a score of 60% for Monocytes, resulting in an unsatisfactory score of 60% for WBC Differential on the 2020 Hematology 1st event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 20% for Lymphocytes, resulting in an unsatisfactory score of 67% for WBC Differential on the 2020 Hematology 2nd event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API (American Proficiency Institute) proficiency testing results 9/10/20, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 API (American Proficiency Institute) proficiency testing results 9/10/20, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 40% for Granulocytes and a score of 60% for Monocytes, resulting in an unsatisfactory score of 60% for WBC Differential on the 2020 Hematology 1st event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory received a score of 20% for -- 2 of 3 -- Lymphocytes, resulting in an unsatisfactory score of 67% for WBC Differential on the 2020 Hematology 2nd event. -- 3 of 3 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and testing personnel (TP) interview on 2/18/19, the laboratory failed to discard materials that had exceeded their expiration date and were available for use. Findings: At 3:25 p.m. the surveyor observed 1 box of BD Tiger Top Vacutainer tubes in the Phlebotomy Station that had expired, with the Lot Number: 8044832, and Exp. Dater: 2019-01-31. Upon review, 26 of 100 tubes had been used. During interview of TP, the lead tech, at 3:250 p.m. the staff acknowledged that the tubes were expired, and it was confirmed that their supplier had recently delivered the tubes within the past 30 days. The TP immediately tool possession of the tubes for disposal. 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 --