Cpg Urology

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted by the Pennsylvania State Agency for CPG Urology on 11/20/2025. The laboratory was found out of compliance with the following conditions: 493.1230 Condition: General laboratory systems. 493.1250 Condition: Analytic systems. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on lack of documentation, review of laboratory policy, and interview with the Laboratory Manager (LM), the laboratory failed to ensure Quality Control (QC) was performed as required per manufacturers (Siemens Multistix) and laboratory requirements when dipstick urinalysis examinations were performed for 2 of 2 years from 01/12/2024 to 11/20/2025.for the Siemens Multistix Reagent Strips from 01/12 /2024 to 11/20/2025. Findings include: 1. The Siemens Multistix Reagent Strips packet insert document stated, "Test positive and negative quality control with new lot, new shipments of reagents, and when you open new bottle of reagent strips. Test reagents monthly that are stored for more than 30 days. Run QC tests to ensure reagent integrity; train new users; confirm test performance; and when patients' clinical conditions or symptoms do not match. Also run QC tests per your laboratory procedures." 2. The laboratory's procedure manual stated;" Urine Controls: Will be performed weekly every Thursday. Normal and abnormal urine tested. The lot number of the urine sticks is also recorded." 3. On the day of survey, 11/20/2025, the LM failed to provide documentation for QC performed for 2 of 2 years when dipstick urinalysis examainations were performed from 01/12/2024 to 11/20/2025. 4. The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- laboratory performed 7000 urine dipstick examinations in 2024 (CMS 116, estimated annual volume, dated 11/20/2025). 5. The LM confirmed the findings above on 11/20 /2025 at 9:30 a.m. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of documentation, record review of the laboratory's procedure manual and interview with the Laboratory Manager, (LM), the laboratory failed to meet applicable general laboratory systems requirements in 493.1231 through 493.1236 for 2 of 2 years from 01/12/2024 to date of survey. Refer to D5217 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 lack of documentation, review of the laboratory's procedure manual, and interview with the Laboratory Manager (LM) ,the laboratory failed to verify twice annually the accuracy of Post-Vasectomy Semen Analysis (PV), examinations performed 2 of 2 years from 01/12/2024 through the date of the survey. Findings include: 1. Review of the laboratory's Post Vasectomy Qualitative Semen Analysis Procedural Guidelines revealed "every six months a peer comparison semen analysis is done". 2. On the day of survey, 11/20/2024 at 08:45 am, the laboratory could not provide documentation of verification of accuracy for PV (presence or absence) examinations performed from 01/12/2024 through the date of the survey. 3. The laboratory performed 501 PV examinations in 2024 (CMS 116, estimated annual volume, dated 11/20/2025). 4. The LM confirmed the findings above on 11/20/2025 at 09:30 a.m. ** Repeat Deficiency** D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. -- 2 of 4 -- This CONDITION is not met as evidenced by: Based on lack of documentation, record review of laboratory procedure, and interview with Laboratory Manager (LM), the laboratory failed to meet applicable analytic systems requirements in 493.1251 through 493.1283 for 2 of 2 years from 01/12/2024 to date of survey. Refer to D5449 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 lack of documentation and interview with the Laboratory Manager (LM), the laboratory failed to monitor and document room humidity to ensure operating conditions were met for 1 of 1 Accu-Scope microscope used to perform Post Vasectomy Semen Analysis (PV) examinations from 01/12/2024 to 11/20/2025. Findings include: 1. The manufacturers operating environment specifications stated the following: -Accu-Scope microscope: maximum 80 % relative humidity 2. On the day of the survey, 11/20/2025, the laboratory failed to provide documentation for the monitoring of room humidity to ensure operating conditions were met for the following instruments used to perform PV examinations from 01/12/2024 to 11/20 /2025: - 1 of 1 Accu-Scope microscope 3. The laboratory performed 501 PV examinations in 2024 (CMS 116, estimated annual volume, dated 11/20/2025). 4. The LM the above findings on 11/20/2025 at 09:30am. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure for Post Vasectomy Semen Analysis, Semen Analysis Logs, and interview with the Laboratory Manager (LM), the laboratory failed to ensure a positive an negative control material was included each day patient specimens for pst-vasectomy semen analysis (PV) were examined for 2 of 2 years from 01/12/2024 to 11/20/2025. Findings include: 1. The laboratory's Policy and Procedure for Post Vasectomy Semen Analysis stated, "The physician will compare the slide with the QC visuals to determine the presence of sperm. The physician will complete and initial the Semen Analysis log as well as initial the QC portion of the log." 2. On the day of survey , 11/20/2025 at 9:00 am, review of the laboratory's Semen Analysis Logs revelaed a negative and positive visual control was not documented each day PV (presence or absence) testing was performed for 2 of 2 years from from 01/12/2024 to 11/20/2025. 3. The laboratory reported a total volume of 501 PV examinations were performed annually (CMS 116, estimated annual -- 3 of 4 -- volume, dated 11/12/2025). 4. The LM confirmed the above findings on 11/20/2025 at 9:00 am. ** Repeat Deficiency** -- 4 of 4 --

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 lack of documentation, review of the laboratory's procedure manual and interview with the Laboratory Manager (LM) ,the laboratory failed to verify twice annually the accuracy of Post-Vasectomy examinations performed from 01/11/2022 through the date of the survey. Findings include: 1. On the day of survey, 01/12/2024 at 08:29 am, the laboratory could not provide documentation of verification of accuracy for Post-Vasectomy examinations (semen analysis for presence or absence) performed from 01/11/2022 through the date of the survey. 2. According to the laboratory's Post-Vasectomy Qualitative Semen Analysis Procedural Guidelines, every six months a peer comparison semen analysis is done. 3. The laboratory reported a total of 500 semen analysis examinations were performed annually (CMS116). 4. The LM confirmed the findings above on 01/12/2024 at 09:45 a.m. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD 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 2 -- Based on review of the laboratory's policy and procedure for Post Vasectomy Semen Analysis, Semen Analysis Logs and interview with the Laboratory Manager (LM), the laboratory failed to document a positive and negative control each day patient specimens were examined for post-vasectomy semen analysis from 01/11/2022 to 01 /12/2024. Findings include: 1. The laboratory's Policy and Procedure for Post Vasectomy Semen Analysis states, "The physician will compare the slide with the QC visuals to determine the presence of sperm. The physician will complete and initial the Semen Analysis log as well as initial the QC portion of the log." 2. Semen Analysis Logs reviewed at the time of survey on 01/12/2024 at 08:12 am, revealed no documentation of a negative and positive visual control, each day patient testing (semen analysis for presence or absence) was performed from 01/11/2022 to 01/12 /2024. 3. The laboratory reported a total volume of 500 semen analysis examinations were performed annually (CMS116). 4. The LM confirmed the above findings on 01 /12/2024 at 9:45 am. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on personnel interview of the Practice Manager and the Surgical Technician and review of the laboratory procedure manual in use on the date of the survey (01/11 /2022), the laboratory personnel failed to follow the written procedure for post vasectomy semen analysis, from (04/27/2021) through (01/06/2022}. Findings include: 1. Post vasectomy semen analysis was performed on 28 specimens, from (04 /27/2021) through (01/06/2022}. 2. The procedure requires the physician to complete the QC portion of the semen analysis log. 3. 0 of 28 specimens had the QC portion of the semen analysis log completed. 2. During the survey (11:30 01/11/2022), the Practice Manager confirmed the above findings. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory policies and interview with the practice manager and a certified surgical technologist, the laboratory failed to establish a quality assessment (QA) policy for post vasectomy examinations analyzed from 12/20/2017 to the date of survey. Findings Include: 1. On the day of survey, 09/10/2019, the laboratory failed to provide a QA policy to assess the laboratory's pre-analytic, analytic and post-analytic systems from 12/20/2017 to 09/09/2019. 2. The practice manager and a certified surgical technologist confirmed the finding above from 09/10/2019 around 12:25 pm D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory quality control (QC) records and interview with the practice manager and a certified surgical technologist, the laboratory failed to 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 -- document QC procedures each day of patient testing on 81 of 96 post vasectomy examinations analyzed from 12/20/2017 to the date of survey. Findings Include: 1. On the day of survey, 09/10/2019, review of QC records revealed, the laboratory director did not document QC procedures each day of patent testing on 81 of 96 post vasectomy examination analyzed from 12/21/2017 to 09/10/2019. 2. In 2018, 72 post vasectomy examination were analyzed. 3. In 2019 (01/01/2019 to 09/10/2019) 9 post vasectomy examination were analyzed. 4. The practice manager and a certified surgical technologist confirmed the findings above from 09/10/2019 around 12:15 pm. ***Repeat Deficiency*** -- 2 of 2 --