Urology Group, Pc, The

Summary Statement of Deficiencies 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 observation of the laboratory, review of laboratory policy, lack of records, and staff interviews, the laboratory failed to perform function checks for the centrifuges used to process patient blood samples for chemistry testing in 2023 and 2024. The findings include: 1. Observation of the laboratory on 03/20/2024 at 10:00 am revealed three Druker Diagnostics 642E centrifuges used to centrifuge patient blood samples for serum chemistry testing on the Beckman Coulter Unicel 600 (Serial# 901338) instrument. 2. A review of the laboratory policy titled "Specimen Collection and Handling" section "Serum Samples" revealed patient blood samples would be centrifuged for 10 minutes at 3000 revolutions per minute (RPM) for chemistry testing. 3. Documentation of centrifuge timer and RPM function checks were not available on the date of the survey (03/20/2024) for 2023 or 2024. 4. An interview with the technical consultant and laboratory lead on 03/20/2024 at 11:00 am confirmed the laboratory used the Druker Diagnostics 642E centrifuges to process patient serum samples for chemistry testing on the Beckman Coulter Unicel 600 chemistry instrument and did not have documentation for centrifuge timer and RPM function checks for 2023 or 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 2 -- D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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 Aspen Web 116 database specialties, the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), lack of records, and staff interview, the laboratory director failed to ensure compliance with 493.51(c) which requires laboratories to notify the state agency of deletions or changes in test methodologies included in a specialty or subspecialty, or both, within six months of the change, when the laboratory stopped patient testing for the bacteriology and mycology sub-specialties in December 2022 and failed to notify the state agency of the change. The findings include: 1. Review of the Aspen Web 116 database revealed the laboratory's CLIA certification included the sub-specialties of bacteriology and mycology. 2. A review of the Form CMS 116 submitted for the survey on 03/20/2024 did not include bacteriology and mycology as specialties. 3. Documentation of state agency notification for the deletion of bacteriology and mycology was not available on the date of the survey (03/20/2024) 4. An interview on 03/20/2024 with the technical consultant and laboratory lead at 11:00 am confirmed the laboratory ceased testing for bacteriology and mycology in December 2022 and failed to notify the state agency of the changes. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, document request, and staff interview, the laboratory failed to follow the procedure for verification of accuracy of cytology procedures in November 2021 and May 2022 resulting in the laboratory not verifying the accuracy of cytology procedures twice a year in 2021 and 2022. The findings include: 1. Review of the laboratory procedure manual revealed that verification of the accuracy of cytology procedures would be accomplished by splitting five samples with another laboratory twice a year in May and November for case review for concurrent diagnosis. 2. Request for documentation of the twice a year verification of accuracy of cytology procedures on 06/09/2022 at 1 pm to the laboratory lead testing person revealed no records were available for the verification due in November 2021 and May 2022. 3. Interview with the laboratory lead testing person on 06.09.2022 at 1:30 pm confirmed the laboratory failed to follow the laboratory procedure for verification of accuracy of cytology procedures in November 2021 and May 2022, resulting in the laboratory not verifying the accuracy of cytology procedures twice a year in 2021 and 2022. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, patient test records and email communication, and staff interview, the laboratory director failed to approve the procedures used in the molecular laboratory prior to patient testing which began on 07.16.2021 with approximately 4,430 patient reported from 07.16.2021 until the date of the survey on 06.09.2022. The findings include: 1. Observation of the laboratory on 06.09.2022 at 9 am revealed molecular based high- complexity laboratory-developed testing being performed in suite 110 for bacterial identification and bacterial antibiotic resistance. 2. Review of the laboratory procedure manual revealed the procedures for the molecular laboratory had not been approved the laboratory director. 3. Review of patient test records revealed the first patient was reported on 07.16.2021 (patient accession #175204.07162021). Review of email communication received on 06.14.2022 from the general supervisor of the molecular laboratory revealed approximately 4,430 patients have been reported since testing began on 07.16.2021 without procedures that were approved by the lab director. 4. Interview with the general supervisor of the molecular laboratory on 06.09.2022 at 2: 30 pm confirmed the laboratory director failed to review and approve procedures used for molecular testing prior to patient testing with the first patient reported on 07.16.2021. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of quality control (QC) records, patient test records and staff interview, the laboratory failed to verify the QC limits used for Lot 125467-Level three for the p2Prostate Specific Antigen (p2PSA) resulting in the use of incorrect QC limits from 03.30.2022 to 05.27.2022 with approximately 403 patients reported during the period the incorrect ranges were in use (one of nineteen lots reviewed for QC limits). The findings include: 1. Observation of the laboratory on 06.09.2022 at 8:30 am revealed the Beckman Coulter UniCel DxI 600 Access Immunoassay System (serial #901338) instrument in use for performing p2PSA patient testing. 2. Review of the laboratory's quality control records revealed the use of incorrect QC limits for p2PSA as follows: Lot 125467 - level three - manufacturer stated assay range = 958.15 +/- 143.72, range in use = 985.15 +/- 143.72. The incorrect ranges for p2PSA level three were in use from 03.30.2022 until 05.27.2022. 3. Review of patient # 127417 revealed p2PSA reported during the period the incorrect QC ranges were use. Further review of the laboratory activity report for the p2PSA test revealed approximately 403 patients were reported during the period when -- 2 of 3 -- the incorrect ranges were in use. 4. Interview with the lead testing person on 06.09.2022 at 4:30 pm confirmed the laboratory failed to verify the QC ranges in use for p2PSA for lot 125467-level three in 2022 with approximately 403 patients reported during the period the incorrect ranges were in use (one of nineteen lots reviewed for QC limits). D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure 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 D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with the technical consultant, the laboratory failed to test proficiency testing samples in the same manner as patient specimens in 2018 and 2019. The findings include: 1) Review of the laboratory's proficiency testing records revealed the following: 2018 Event Two Chemistry-Miscellaneous: Instrument printouts -- PSA, Free PSA and Testosterone performed multiple times for all three samples. 2018 Event Three Hematology /Coagulation Urinalysis Instrument printouts - Both samples were tested in duplicate- once on each instrument. 2019 Event One Hematology/Coagulation Urinalysis Instrument printouts -- Both samples were tested multiple times, by multiple personnel, on multiple dates and on multiple instruments. 2) Interview with the technical consultant on May 1, 2019 at 12:20 pm confirmed the laboratory failed to test proficiency samples the same as it tests patient samples when it performed repeat testing of proficiency testing samples. The laboratory does not routinely repeat patient testing. ___________________________________ D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of patient test reports, laboratory records, and interview with the laboratory director, the laboratory failed to verify the accuracy of cytology and histopathology twice a year in 2017, 2018, and 2019. The findings include: 1) Review of patient numbers 17, 18, 19, 20, 22, 23, 24, 25 and 26 revealed patient testing performed for cytology and histopathology in 2017, 2018, and 2019. 2) Review of laboratory records revealed no records were available documenting accuracy twice a year in 2017, 2018, and 2019 for cytology and histopathology. 3) Interview with the laboratory director on May 1, 2019 at 12:15 pm confirmed no records were available documenting accuracy twice a year in 2017, 2018, and 2019. __________________________________ D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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: Citation number one Based on review of the laboratory procedure manual, calibration records, patient test report, quality control records and interview with the technical consultant, the laboratory failed to follow the procedure for quality control in 2019. The findings include: 1) Review of the laboratory procedure titled "QUALITY CONTROL ASSESSMENT" revealed that quality control is to be performed after "calibration of analyte." 2) Review of the calibration records revealed calibration of testosterone on 04.22.2019 at 01:12 pm. 3) Review of patient number twenty one test report revealed testosterone reported on 04.22.2019 at 4:24 pm. 4) Review of April 2019 quality control records for testosterone revealed that quality control was not performed following calibration of testosterone on 04.22.2019 with patient testing performed. 5) Interview with the technical consultant on May 1, 2019 at 4:00 pm confirmed the laboratory failed to follow the quality control procedure when it did not perform quality control after calibration in 2019. ______________________________________ Citation number two Based on observation of the laboratory, the laboratory procedure manual for urinalysis, and interview with the lead testing personnel, the laboratory failed to follow procedure for recording urine color and clarity in 2019. The findings include: 1) Observation of the laboratory on May 1, 2019 at 8:30 am revealed two Clinitek Advantus urinalysis instruments in use for patient testing. Testing personnel were observed performing urinalysis testing and did not enter color and clarity of the urine specimen into the urinalysis instrument. 2) Review of the laboratory procedure manual for urinalysis revealed "Enter the color and clarity of each specimen before dipping the urine strip." 3) Interview with testing personnel number one on May 1, 2019 at 8:45 am confirmed the laboratory personnel did not enter the color and clarity of the urine sample into the urinalysis instrument. The instrument is set to default to yellow and clear and testing personnel do not change the color and clarity to reflect the true urine color and clarity. -- 2 of 5 -- Testing personnel number one stated they are too busy to enter the observations. The testing personnel failed to follow procedure for entering color and clarity of urine specimens in 2019. ____________________________________ D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of patient test reports and laboratory records, and interview with the laboratory director, the laboratory failed to record stain quality control in 2019. The findings include: 1) Review of patient test reports for surgical pathology revealed the following: Patient number 18--prostate biopsy-reported on 4.26.19 Patient number 19-- bladder biopsy-reported on 5.1.19 Patient number 20-surgical pathology for vas deferens-reported on 5.1.19 2) Review of laboratory records revealed no stain quality control documentation on 4.26.19 or 5.1.19. 3) Interview with the laboratory director on May 1, 2019 confirmed the laboratory does not document quality control for histology stain each day of use. ___________________________________ D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of patient test report and interview with the laboratory director, the laboratory failed to document quality control for immunohistochemical (IHC) stains in 2019. The findings include: 1) Review of patient number 22 prostate biopsy test report revealed the use of IHC stains. 2) Review of laboratory records revealed no documentation of quality control for the IHC stain. 3) Interview with the laboratory director on May 1, 2019 at 12:15 pm confirmed the laboratory does not document IHC stain quality control. ____________________________________ D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on review of patient test reports, laboratory records and interview with the laboratory director the laboratory failed to maintain workload records for cytology in 2017, 2018, and 2019. The findings include: 1) Review of patient number 17 test report revealed patient reporting for urine cytology on 4.29.19. 2) Review of laboratory records revealed no workload records for the individual examining the slide were maintained. 3) Interview with the laboratory director on May 1, 2019 at 12: 15 pm confirmed the laboratory director performs patient testing for cytology and failed to maintain cytology workload records. ___________________________________ D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of instrument comparison records, and interview with the technical consultant, the laboratory failed to compare results between urinalysis instruments twice a year in 2017, 2018, and 2019. The findings include: 1) Observation of the laboratory on May 1, 2019 at 8:30 am revealed two moderately complex urinalysis instruments in use for patient testing: Clinitek Status Advantus serial numbers 85931526 and 02761628. 2) Review of instrument to instrument comparison records revealed no twice a year comparison in 2017, 2018, and 2019. 3) Interview with the technical consultant on May 1, 2019 at 1:30 pm confirmed the laboratory failed to compare results between the two moderately complex urinalysis instruments in 2017, 2018, and 2019. __________________________________ D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the Clinitek Advantus Operator's Guide, patient test reports, and interview with the technical consultant, the final patient test report for urinalysis failed to include units of measure (UOM) in 2017, 2018, and 2019. The findings include: 1) -- 4 of 5 -- Review of the Clinitek Advantus Operator's Guide and patient urinalysis test reports (#1 dated 4.29.19, #5 dated 11.6.18, #9 dated 2.14.18 and #13 dated 08.01.17) revealed the following: Glucose: Operator guide UOM = mg/dL, patient test reports=No UOM Protein: Operator guide UOM = mg/dL, patient test reports=No UOM Protein:Creatinine Ratio: Operator guide Correct UOM = mg/g, patient test reports =mg/dL 2) Interview with the technical consultant on May 1, 2019 at 4:00 pm confirmed the laboratory final patient urinalysis test report did not include UOM for glucose and protein and had incorrect UOM for protein:creatinine ratio in 2017, 2018 and 2019. ___________________________________ -- 5 of 5 --