Urological Associates, Ltd

Summary Statement of Deficiencies D0000 An off-site CLIA proficiency testing (PT) desk review was conducted for Urological Associates, LTD on November 12, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The survey concluded with an interview with the Primary Testing Personnel on November 12, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The facility was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 CFR. 493.803 Condition: Successful Participation D6000 - 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: 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 -- Based on a review of the Certification and Survey Provider Enhanced Reporting (CASPER 0155) report, the laboratory's proficiency testing (PT) records and interview, the laboratory failed to successfully participate in the Endocrinology subspecialty and Testosterone analyte for two consecutive PT testing events. The laboratory had unsatisfactory Endocrinology and Testosterone scores for the second and third events of calendar year 2025. Refer to D2107 and D2108. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (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 desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, American Proficiency Institute (API) PT records, and interview, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for Testosterone for two consecutive Endocrinology events in calendar year 2025 resulting in an initial unsuccessful PT performance as reviewed on the date of the inquiry on November 12, 2025. The findings include: 1. Review of the CASPER 0155 report revealed the following results: Chemistry 2025 - 2nd Event - unsatisfactory score of 0% for analyte 0570 Testosterone; Chemistry 2025 - 3rd Event - unsatisfactory score of 0% for analyte 0570 Testosterone. 2. Desk review of the API 2025 PT records outlined above revealed unsatisfactory Testosterone scores of less than 80% for the following 2 consecutive Endocrinology events: 2025 API 2nd Event: Testosterone scored 0% 2025 API 3rd Event: Testosterone scored 0% resulting in an initial unsuccessful PT performance noted by API. 3. In a phone interview with the Office Administrator on November 12, 2025, at 9:20 AM, they stated they have not performed Testosterone testing since November 2024 and confirmed the above findings. D2108 ENDOCRINOLOGY CFR(s): 493.843(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 a desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, American Proficiency Institute (API) PT records, and interview, the laboratory failed to achieve overall satisfactory performance of at least eighty percent (80%) for the Endocrinology subspecialty for two consecutive Endocrinology events in calendar year 2025 resulting in an initial unsuccessful PT performance as reviewed on the date of the inquiry on November 12, 2025. The findings include: 1. Review of the CASPER 0155 report revealed the following results: Chemistry 2025 - 2nd Event - unsatisfactory score of 0% for subspecialty 0525 Endocrinology; Chemistry 2025 - 3rd Event - unsatisfactory score of 0% for subspecialty 0525 Endocrinology. 2. A review of the PT testing scores from API (2025 Events 2 & 3) confirmed the above findings. 3. In a -- 2 of 3 -- phone interview with the Practice Administrator on November 12, 2025, at 9:20 AM, they stated they have not performed Testosterone testing since November 2024 and 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 an off-site desk review of the Certification and Survey Provider Enhanced Reporting (CASPER 0155) report, the laboratory's 2025 proficiency testing (PT) records and interview, the laboratory director (LD) failed to provide overall management and ensure the overall quality of the laboratory services provided. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER 0155) report, the laboratory's 2025 proficiency testing (PT) records, and interview, the laboratory director (LD) failed to ensure the overall quality of the laboratory services provided. The LD failed to ensure successful participation in their Health and Human Services (HHS) approved PT program. Refer to D2107 and D2108. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Urological Associates, LTD on July 18, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency cited is as follows: D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, the laboratory's policies and procedures, lack of documentation and interviews, the laboratory director failed to follow the laboratory's established policy to ensure two of two new TP had documented training /competency assessments prior to performing patient testing procedures utilizing the Qualigen FastPack IP System for prostatic specific antigen (PSA) and testosterone (Testo) analysis on the date of survey on July 18, 2024. The findings include: 1. Review of CLIA CMS-209 form revealed TP A and TP B listed as performing patient testing utilizing the Qualigen FastPack IP System. (See attached TP Code Sheet.) 2. Review of TP records and an interview with the primary TP on July 18, 2024 at 10:15 AM revealed TP A was hired/began patient testing utilizing the FastPack System in April 2024 and TP B was hired/began patient testing utilizing the FastPack System in 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 -- May 2024. Further review of the TP A and TP B's personnel records revealed a lack of documentation of the training/initial competency of TP A and TP B. The inspector requested to review training/initial competency assessment documents for TP A and TP B. The laboratory provided no documentation for review. 3. Review of the laboratory's policies and procedures revealed a checklist, "FastPack IP Training Checklist", with the following statement, "Complete this information for any person who will perform tests on the FastPack IP System." 4. In an exit interview with the primary TP on July 18, 2024 at 12:30 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Urological Associates, LTD on November 15, 2022 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and include one Condition under 42 CFR part 493 CLIA Regulation: D6063 -42 CFR. 493.1421 Condition Testing Personnel. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form, testing personnel records, lack of documentation, and interview, the laboratory failed to retain documentation of education qualifications for one of six testing personnel responsible for reporting moderate complexity endocrinology chemistry patient test results during the review timeframe of December 2020 to the date of the inspection on November 15, 2022. See D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in 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 -- chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), personnel records, lack of documentation, and an interview, the laboratory director (LD) failed to retain documentation of education qualifications for one (1) of six (6) chemistry testing personnel (TP) noted on the date of the inspection, November 15, 2022. Findings include: 1. Review of the CMS 209 form revealed the LD identified 6 personnel as qualified to perform moderate complexity endocrinology chemistry Prostate Specific Antigen and Testosterone patient testing on the Qualigen FastPack analyzer during the twenty-three months of review (December 2020 up to 11/15/22). 2. Review of the available laboratory personnel records for evaluation of education documentation revealed no records of education for TP A. *See Personnel Code Sheet. 3. The inspector requested to review the documentation of education for the TP outlined above. The records were not available for review. The office manager stated on 11/15/22 at approximately 1:30 PM, "This staff member has been attempting to get an official transcript from the school and we hope to have it soon." 4. An exit interview with the office manager on 11/15/22 at approximately 3:00 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Urological Associates, LTD on November 23, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 11 /02/2020 and virtual record review conducted on 11/04/2020. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: 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 a review of laboratory equipment, performance verification records for Qualigen FastPack IP System 2 analyzers, patient test logs, lack of documentation, and interviews, the laboratory director (LD) failed to document review/evaluation of the accuracy, precision, and reportable range for Prostate Specific Antigen (PSA) assays prior to reporting three hundred twenty-five (325) patient results on a newly installed instrument from May 4, 2020 to the date of the inspection record review on November 11, 2020. Findings include: 1. During an entrance interview with the laboratory's office manager and primary testing personnel (TP) on 11/2/20, the inspector was informed of and noted the following four (4) Qualigen FastPack analyzer serial numbers (SN) in use for patient immunoassay PSA and Testosterone testing: Machine 1 (SN 0894; for PSA and Testosterone), Machine 2 (SN 01181; for 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 -- PSA), Machine 3 (SN 0163; for PSA and Testosterone), Machine 4 (SN 0019; for PSA). 2. Review of all analyzer performance verification documentation records, during a virtual record review on 11/4/20, revealed that the laboratory installed two (2) new FastPack instruments in calendar year 2020 (SN 0894 installed on 5/4/20 and SN 1181 installed on 7/13/20). The review of validation documentation for analyzer SN 0894 revealed no LD evaluation or verification of PSA accuracy, precision, or reportable range. The inspector requested to review documentation that the LD verified the Qualigen FastPack validation studies for SN 0894 prior to patient PSA testing. No documentation was available. The primary TP stated: "I recall that we ran the validation samples but I do not have the completed report. The LD has not reviewed, but I can contact Qualigen to find out what happened to our submitted data". 3. Review of patient test logs revealed that the laboratory reported 325 patient PSA results from analyzer (SN 0894) from May 2020 to the date of the survey on 11/4 /20. 4. In an exit interview with the office manager and primary TP, on 11/23/20 at approximately 3:30 PM, the above findings were confirmed. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of laboratory equipment, procedures, maintenance logs, lack of documentation, and interviews, the laboratory failed to define and document function checks for centrifuge revolutions per minute (RPM) for five (5) of 5 centrifuges during the twenty-four (24) months reviewed. Findings include: 1. During an entrance interview with the laboratory's office manager and primary testing personnel (TP) on 11/2/20, the inspector was informed of and noted the following Unico Power Spin centrifuge serial numbers (SN) in use for urine microscopy specimen processing: SN L1909029, SN L0807299, SN L0807162, SN L0807187, SN L71608125. 2. Review of the laboratory's procedures revealed a Microscopic Study of the Urinary Sediment Examination protocol that stated "Centrifuge urine at 1,500 to 2,000 RPM for 5 minutes". 3. Review of the laboratory's maintenance documentation revealed no records of RPM verifications for the 5 Unico centrifuges outlined above. The inspector requested to review centrifuge RPM verification records for the timeframe of November 2018 to the date of the on-site tour on 11/23/20. No documentation was available for review. 4. In an exit interview with the primary TP and office manager, on 11/23/20 at approximately 3:30 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Urological Associates, LTD on August 9, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of