Baton Rouge Urology Group

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: A Follow-up survey was performed at Baton Rouge Urology Group, CLIA # 19D0982695, on July 31, 2024. Based on review of laboratory policies and proficiency testing records as well as interview with laboratory personnel, the laboratory failed to test proficiency testing (PT) samples in the same manner as patient testing for two (2) of four (4) events reviewed. Findings: 1. Review of proficiency testing (PT) records revealed multiple testing personnel attested to performing PT samples as follows: a) 2024 Microbiology - 1st Event: - Samples UR- 01, UR-02, UR-03, UR-04, and UR-05 - all samples tested by the Technical Consultant, Testing Personnel 3, and Testing Personnel 4. b) 2024 Microbiology - 2nd Event: - Samples UR-06, UR-07, UR-08, UR-09, UR-10 - all samples tested by Testing Personnel 1 and Testing Personnel 5. 2. In interview on July 31, 2024 at 11 a. m., the Technical Consultant stated the laboratory does not routinely test patient samples for microbiology testing multiple times. She stated multiple testing personnel tested the same PT samples for evaluation of competency and all testing was performed before the PT event due date passed. She confirmed the PT samples identified above were tested multiple times as identified above. 3. Further review of PT records revealed testing personnel documented the zone size and interpretation for microbiology susceptibility testing for the following events: a) 2024 Microbiology - 1st Event b) 2024 Microbiology - 2nd Event 4. In interview on July 31, 2024 at 2:41 p. m., the Technical Consultant stated the zone sizes for antibiotic disc susceptibility testing for PT samples were measured with a caliper, but the zone sizes for patient samples were not measured with a caliper and instead were measured with a template provided by the manufacturer Becton Dickinson (BD). She further stated testing 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 -- personnel do not document the zone size for patient antibiotic susceptibility testing and only document the interpretation. She confirmed PT samples and patient samples were not tested in the same way for antibiotic susceptibility testing. _______________________________________ A Certification survey was performed at Baton Rouge Urology Group, CLIA ID # 19D9462715 on October 24, 2023. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: A Follow-up survey was performed at Baton Rouge Urology Group, CLIA # 19D0982695, on July 31, 2024. Based on record review and interview with personnel, the Laboratory Director failed to ensure proficiency samples are tested as required. Refer to D2010. _______________________________________ A Certification survey was performed at Baton Rouge Urology Group, CLIA ID # 19D9462715 on October 24, 2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification survey was performed at Baton Rouge Urology Group, CLIA ID # 19D9462715. Baton Rouge Urology was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250: CONDITION: Analytic systems 42 CFR 493.1403: CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1409: CONDITION: Laboratories Performing Moderate Complexity Testing; Technical Consultant 42 CFR 493.1441: CONDITION: Laboratories Performing High Complexity Testing; Laboratory Director 42 CFR 493.1447: CONDITION: Laboratories Performing High Complexity Testing; Technical Supervisor D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: **Repeat deficiency from survey performed on February 16, 2022 ** Based on review of the laboratory's policy, proficiency testing records, and interview with personnel, the laboratory failed to document assessment for unacceptable Routine Chemistry proficiency scores for one (1) out of five (5) events reviewed. Findings: 1. Review of the laboratory's "Proficiency Testing Policy" revealed "Any result that fails to meet the expected and/or acceptable criteria (anything less than 100 %) initiates a

Summary Statement of Deficiencies D0000 A Recertification survey was performed on February 16, 2022 at Baton Rouge Urology Center, CLIA ID # 19D0462715. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of laboratory policy, proficiency testing records and interview with personnel, the laboratory failed to document remedial action for unacceptable Chemistry proficiency testing scores. Findings: 1. Review of the laboratory's "Proficiency Testing Policy" revealed "Any result that fails to meet the expected and /or acceptable criteria initiates a

Summary Statement of Deficiencies D0000 A PT Desk Review was performed on June 10, 2021. Baton Rouge Urology Group- 19D0462715 was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 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 proficiency testing results from the CMS-153, CMS-155D and American Academy of Family Physicians (AAFP), the laboratory failed to successfully participate in proficiency testing as evidence by: 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 2 -- to achieve a score of at least 80% for Alanin Aminotransferase (ALT) in two consecutive events, resulting in initial unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 a review of proficiency testing results from the CMS-153, CMS-155D and American Academy of Family Physicians (AAFP), the laboratory failed to achieve a score of at least 80% for Alanin Aminotransferase (ALT) in two consecutive events, resulting in initial unsuccessful performance. . Findings are: 1. Review of American Academy of Family Practice (AAFP) proficiency testing results and CMS Report 0153D and 0155D revealed the laboratory received unsatisfactory performance for the following two events resulting in the first unsuccessful participation for ALT, Total: Event 3 of 2020 received a score of 60% Event 1 of 2021 received a score of 60% 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. 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: The laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to achieve a score of at least 80% for Alanin Aminotransferase (ALT) in two consecutive events, resulting in initial unsuccessful performance. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on October 3, 2019 at Baton Rouge Urology Group, CLIA ID # 19D0462715. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to label opened quality controls with an expiration date. Findings: 1. Observation by surveyor during the laboratory tour on October 3, 2019 revealed open and in use Streck and Bio-Rad Multiqual quality control material in the refrigerator with no open, in use or expiration date. 2. Record review revealed the laboratory uses Streck material for Complete Blood Count (CBC) testing and Bio-Rad Multiqual for Chemistry testing. 3. Review of the Multiqual package insert revealed "Once thawed, opened, and stored tightly at 2-8 degrees C, this product is stable for 20 days." Review of the Streck package insert revealed an open vial stability of 30 days. 4. In interview on October 3, 2019, Personnel 2 confirmed the identified open controls were not labeled with an expiration date. D5783