Comprehensive Urology Medical Group

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 05/01/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and AAB-Medical Laboratory Evaluation (AAB) and American Proficiency Institute (API) records (2024-2, 2024-3, and 2025-1), the laboratory failed 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 -- 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 analytes: RBC, HCT, HGB, WBC COUNT, and PLATELETS resulting in subsequent unsuccessful performances. Refer to D2130 and 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 desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile, API and AAB evaluation reports, the laboratory failed to achieve satisfactory performances for three consecutive events in 2024 and 2025, resulting in subsequent unsuccessful performances. The laboratory received the following scores: a. RBC, analyte: 2024-2 API 0%, 2024-3 API 0%, and 2025-1 AAB 0%; b. HCT, analyte: 2024-2 API 0%, 2024-3 API 0%, and 2025-1 AAB 0%; c. HGB, analyte: 2024-2 API 0%, 2024-3 API 0%, and 2025-1 AAB 0%; d. WBC COUNT, analyte: 2024-2 API 0%, 2024-3 API 0%, and 2025-1 AAB 0%; e. PLATELETS, analyte: 2024-2 API 0%; 2024-3 API 0%, and 2025-1 AAB 0%. A review of the 2024 and 2025 Proficiency Testing scores from API and AAB-Medical Laboratory Evaluation confirmed the above findings. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API and AAB evaluation reports, the laboratory failed to achieve overall testing event scores of satisfactory performance for consecutive events (2024-2, 2024-3, and 2025-1) resulting in subsequent unsuccessful for the specialty of Hematology. The finding include: Hematology: 2024-2 API 0%, 2024-3 API 0%, and 2025-1 AAB 0%; 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 a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report API and AAB records for 2024-2, -- 2 of 3 -- 2024-3 and 2025-1 events, the laboratory director failed to provide overall management and a direction of the laboratory services. 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 Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report API & AAB records for 2024-2, 2024- 3 and 2025-1 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing programs. Refer to D2130 and D2131. -- 3 of 3 --

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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) -0155D and AAB - American Board of Bioanalysis (AAB) records (2023- 3 and 2024-1), the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty in which the laboratory is certified under CLIA the laboratory failed to successfully participate in the subspecialty of Bacteriology resulting in subsequent unsuccessful performance. Refer to D2020. D2020 BACTERIOLOGY 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 -- CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and AAB - American Board of Bioanalysis (AAB) report, the laboratory failed to achieve satisfactory performance for two consecutive events (2023 third testing event and 2024 first testing event) for the subspecialty of Bacteriology: The finding include: 67% on the 2023 third event 65% on the 2024 first event A review of the 2023 and 2024 scores from AAB - American Board of Bioanalysis confirmed the above findings. 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 a proficiency testing desk review of the CASPER 0155 report and AAB records for 2023-3 and 2024-1events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to 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 a proficiency testing desk review of CASPER 0155 report and AAB records for 2023-3 and 2024-1 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2020. -- 2 of 2 --

Summary Statement of Deficiencies D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation of the facilities layout, observation of the of the laboratory's Precision UTI, STI, vaginitis, and yeast organisms panels for the detection of bacterial and fungal organisms using the Polymerase Chain Reaction (PCR) test, and interviews with the laboratory testing personnel (TP) on March 26, 2021 on its molecular amplification procedure; it was determined that the laboratory failed to ensure that the molecular amplification procedures which are not contained in closed systems have a unidirectional flow with separate areas for specimen preparation, reagent preparation, RNA extraction, amplification, and RNA detection. The findings included: 1. The laboratory performed PCR testing for the presumptive detection of multiple microbial agents using Precision microorganism's panels for molecular detection. 2. During the laboratory tour on 03/26/2021 at approximately 11: 30 a.m. the examiner observed that specimen preparation, reagent preparation, RNA extraction, amplification, and RNA detection were all performed in the same room- area. 3. The TS confirmed by interview on March 23, 2021 at approximately 11:40 a. m. that the laboratory's molecular PCR testing for the presumptive detection of UTI, STI, vaginitis and yeast organisms was not set up in separate rooms with unidirectional flow. 5. Based on laboratory records, the laboratory performed and reported approximately 2,546 molecular diagnostic tests since started testing by PCR on September 2020. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 3 -- 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 the lack of laboratory written policies and procedures and interview with the General supervisor (GS) and testing personnel (TP), it was determined that the laboratory failed to establish and follow written procedures for the molecular section. The findings included: 1. On the day of the survey 03/26/2021 at approximately 11:30 a.m. the laboratory failed to provide written policies and procedures for the molecular testing section. 2. For three (3) out of eight (3) random patient test results reviewed covering period from January 11/20/2019 to 02/17/2021; UTI, STI, vaginitis, and Mycology panels for molecular detection of multiple micro-organisms were ordered, analyzed, and reported for which the laboratory had no policies and procedures written. 3. The GS and TP confirmed on 03/26/2021 at approximately 1:00 p.m. that the laboratory lacked established written policies and procedures for the molecular section. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on interview with the laboratory testing personnel (TP) on March 26, 2021 and review of laboratory records; it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the pre-analytic, analytic, and post-analytic phases of clinical testing for the molecular detection of organisms. The findings included: 1. The laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in all phases of testing for the Polymerase Chain Reaction (PCR) procedure prior to reporting patient test results. 2. The laboratory staff confirmed on 03/26/2021 at approximately 12:00 p.m. that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in all phases of PCR testing. 4. Based on the declaration of test volumes for the year 2020 submitted on 03/26/2021; the laboratory processed and reported 2,546 PCR test procedures D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the lack of separate areas for specimen preparation, amplification and product detection, and reagent preparation (D3005), established policies and procedures for molecular testing (D5401), and failure to establish a Quality Assurance program for molecular testing from pre-analytic, analytic, and post-analytic phases of clinical testing (D5791); it was determined that the laboratory director failed to ensure that testing systems developed and used for each tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. -- 3 of 3 --