Tennessee Valley Urology Center Pc

Summary Statement of Deficiencies D0000 The Tennessee Valley Urology Center P.C. laboratory was found to be in compliance with the requirements at 42 CFR, Part 493, 'Requirements for Laboratories' as a result of an onsite survey on 09.23.2024. 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 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual and interview with the laboratory's lead testing person, the laboratory failed to provide specimen labeling instructions for urine and semen specimen collection from May 2022 to February 13, 2023. The findings include: 1. Review of the laboratory's collection procedure manual for urine and semen specimen collection failed to provide specimen labeling instructions for urine and semen specimen collection. 2. Interview with the laboratory's lead testing person on 02/13/23 at 10:45 am confirmed the laboratory failed to provide specimen labeling instructions in the laboratory's collection procedure manual for urine and semen specimen collection from May 2022 (when new procedure was adopted) to February 13, 2023. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. 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 -- (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation of the laboratory, review of the laboratory's environmental logs, and interview with the laboratory's lead testing person, the laboratory failed to monitor laboratory humidity for 25 of 25 months from January 2021 through February 13, 2023. The findings include: 1. Observation of the laboratory on 2.13.2.2023 at 10:30 a.m. revealed a thermometer/hygrometer on the laboratory counter. 2. Review of the laboratory's environmental logs revealed no documentation of humidity from January 2021 through February 13, 2023. 3. Interview on 2.13.2023 at 10:45 a.m. with the laboratory's lead testing person confirmed the laboratory failed to monitor laboratory humidity for 25 of 25 months from January 2021 through February 13, 2023. -- 2 of 2 --

Summary Statement of Deficiencies 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: =================================== The laboratory director failed to ensure personnel were competent to perform test procedures (Refer to D6004) and failed to review proficiency testing records (Refer to D6018). =================================== D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: =================================== Based on review of the laboratory's competency evaluations and upon interview with the Office Manager, it was 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 -- determined that the Laboratory Director did not document annual competency for three of four testing personnel. The findings include: 1. Review of laboratory's annual competency evaluations were not documented by the Laboratory Director in 2020 or 2021 for three of four testing personnel. 2. Interview with the Office Manager at approximately 12:30 p.m. July 20, 2021 confirmed no annual competency evaluations were documented by the Laboratory Director in 2020 or 2021 for three of four testing personnel. =================================== D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: ___________________________________ Based on a review of the procedure manual, employee training/competency records for 2016 and 2017 and interview with the Clinical Coordinator, the laboratory failed to document training and competency upon hire and at the 6 months interval for new personnel. The findings include: 1. Review of the procedure manual revealed training and competenices were required for new hire lab personnel "prior to analyzing patient specimens and at least semi- annually during the first year". 2. Review of the employee training/competency records for 2016 and 2017 revealed no training documented for Clinical Coordinator hired 9/5/17 and no semi-annual competency documented for testing person # 3 hired 3/07/16. 3. Upon interview March 8, 2018 at approximately 12:00 p.m. with the Clinical Coordinator, it was confirmed the laboratory failed to document training and competency upon hire and semi-annually. _____________________________________ D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. 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 -- This STANDARD is not met as evidenced by: ____________________________________ Based on observation of laboratory centrifuge for spinning urines at approximately 9:15 a.m. March 8, 2018, review of urine sediment procedure and interview with the Clinical Coordinator, determined the testing personnel failed to ensure laboratory procedure for processing urine sediment was followed upon installation of new centrifuge 3/05/18. The findings include: 1. Observation of laboratory centrifuge at approximately 9:15 a.m. March 8, 2018, for spinning urines, revealed spin speed at 3334 RPM's (revolutions per minute) and spin time at 10 minutes. 2. Review of urine sediment procedure revealed urine sediment to be spun at 2000 RPM's for 5 minutes. 3. Interview at approximately 11:30 a.m. March 8, 2018 with the Clinical Coordinator confirmed the laboratory testing personnel failed to ensure laboratory procedure for processing urine sediment was followed when the new urine centrifuge was installed 3/5/18. _____________________________________ -- 2 of 2 --