Lowcountry Urology Clinics Pa

Summary Statement of Deficiencies D0000 An onsite announced CLIA recertification survey was conducted at Lowcountry Urology Clinics PA on June 9, 2026, by the South Carolina Department of Public Health (SC DPH), Bureau of Nursing Homes and Medical Services. The facility was found to be out of compliance with the Medicare Condition 42 CFR Part 493, CLIA laboratory requirements. The following STANDARD LEVEL DEFICINCIES were found to be out of compliance as a result of the recertification survey on June 9, 2026: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on direct observation, lack of documentation, and staff interview, the laboratory failed to establish and/or follow written policies and procedures that ensure optimum integrity of a patient's specimen form the time of collection or receipt of the specimen through completion of testing and reporting of results. Findings included: 1. During a tour of the laboratory on June 9, 2026, at 3:36 pm the surveyor directly observed urines on the counter next to the Clarity urine analyzer. 2. Review of the urine labels reveals no time of collection was written on any of the urine containers. 3. In an interview on June 9, 2026, at 4 pm in the conference room with office manager and assistant office manager the above findings were confirmed. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, lack of documentation for urological sediments and semen analysis testing, and staff interview, the laboratory failed to document twice annually the accuracy of all testing personnel performing microscopic examination for moderately complex testing for 4 out of 4 testing personnel (Providers Performing microscopic examination). Findings included: 1. Review of American Proficiency Institute (API) records reveal the following: a. 2024 Hematology/Coagulation-3rd Event: Andrology Sperm (presence/absence) (PMO) score 100% Sperm Motility (pres /abs)(PMO) score 100% Microscopy Urine Sediment score 100% b. 2025 Hematology /Coagulation-2nd Event: Andrology Sperm (presence/absence) (PMO) No score documented Sperm Motility (pres/abs)(PMO) No score documented Microscopy Urine Sediment score 0% c. 2025 Hematology/Coagulation-3rd Event: Andrology Sperm (presence/absence) (PMO) score 50% Sperm Motility (pres/abs)(PMO) 100% Microscopy Urine Sediment score 100% d. 2026 Hematology/Coagulation-3rd Event: Andrology Sperm (presence/absence) (PMO) score 0% Sperm Motility (pres/abs) (PMO) score 0% Microscopy Urine Sediment score 0% The laboratory lacked twice annual verification of accuracy for 3 out of 3 years reviewed (2024, 2025, and 2026). 2. The surveyor requested and the laboratory failed to provide documentation of urine sedimentation and qualitative semen analysis accuracy verification on the day of inspection for the following testing personnel: a. TP1 b. TP2 c. TP3 d. TP4 3. In an interview on June 9, 2026, at 4 pm in the conference room with office manager and assistant office manager the above findings were confirmed. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation, lack of documentation, and staff interviews, the laboratory failed to ensure thermometers (equipment) did not exceed their expiration date. Manufacturers require specific storage and operating temperatures to operate efficiently. Findings included: 1. During a tour on June 9, 2026, at 3:36 pm the surveyor directly observed thermometers used to record room and refrigerator temperatures. 2. The surveyor requested and the laboratory failed to provide the verification of thermometers calibrations and/or documentation of the calibration expiration date. a. ThermPro thermometer expired April 31, 2024 b. Refrigerator thermometer no calibration information available. 3. In an interview on June 9, 2026, at 4 pm in the conference room with office manager and assistant office manager the above findings were confirmed. D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of -- 2 of 6 -- patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and staff interview, the laboratory failed to document all test result comparison activities for 3 out of 3 years reviewed (2024, 2025, and 2026). Findings included: 1. Review of policy and procedure titled "Quality Assurance Plan", section D. Comparison of Test Results: Reference 493.1709, Method: States "In an office with more than 1 physician or physician extender, those personnel reading urine macroscopics, wet preps and KOH preps should, twice annually, read the same specimen in order to determine if the practitioners are reporting the results in the same manner. 2. The surveyor request and the laboratory failed to provide documentation of urine microscopy sediment comparison count between the following testing personnel: a. TP1 b. TP2 c. TP3 d. TP4 3. In an interview on June 9, 2026, at 4 pm in the conference room with office manager and assistant office manager the above findings were confirmed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and staff interview, the laboratory failed to follow written policies and procedures for an ongoing assessment and or correct problems identified in the analytic systems for 3 out of 3 years reviewed (2024, 2025, and 2026). Findings included: 1. Review of CMS 116 application reveals moderately complex test qualitative semen analysis are performed by 4 out of 4 testing personnel: a. TP1 b. TP2 c. TP3 d. TP4 2. The surveyor requested and the laboratory failed to provide the established and /or communicated revised policies and procedures to prevent recurrence of the identified problem. The laboratory lacks documentation of the procedure used to prevent proficiency test failures. 3. In an interview on June 9, 2026, at 4 pm in the conference room with office manager and assistant office manager the above findings were confirmed. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted on 8/27/2024. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 record review and interview with staff the laboratory failed to twice annually verify the accuracy of two of two moderately complex tests in 2022 and 2023. a. A review of the CMS-116 revealed the laboratory performed the following moderately complex testing: urine sediments and qualitative semen analysis. b. The laboratory was asked to provide documentation of verification of accuracy. No documentation was provided. c. An interview with the office manager on 8/27/2024 at 12:25 PM in their office confirmed these findings. 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 record review, the laboratory's procedures, and interview with staff 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 3 -- laboratory failed to establish written policies and procedures for the performance of two of two moderately complex test. a. A review of the CMS-116 revealed the laboratory performed the following moderately complex testing: urine sediments and qualitative semen analysis. b. The laboratory was asked to provide written procedures for the performance of urine sediments and qualitative semen analysis. No documentation was provided. c. An interview with the office manager on 8/27/2024 at 12:25 PM in their office confirmed these findings. 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. (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 record review, direct observations, and interview with staff the laboratory failed to establish an acceptable room temperature since 1/1/2022 to 8/27/2024. a. A review of the Daily Temperature Log revealed "Room Temperature should be between 64.4 F and 77 F".(18 degrees to 25 degrees Celsius). Room Temperature was not documented 8/1-8/13 and 8/16-8/22. b. On 8/27/2024 at 10:30 AM the surveyor observed (sampling): BD Vacutainer K2 EDTA: 1 half full pack of 100 lot number 316452, Expiration date 8/31/2024, Storage Temperature 4-25 [degrees Celsius]; 2 full packs of 100 lot number 3318816, Expiration date 3/31/2025, Storage Temperature 4-25 [degrees Celsius]. BD Vacutainer SST: 2 packs of 100 lot number 4130218, Expiration Date 4/30/2025, Storage Temperature 4-25 [degrees Celsius]; 1 pack of 11 lot number 4010734, Expiration Date 12/31/2024, Storage Temperature 4- 25 [degrees Celsius]. c. An interview with the office manager on 8/27/204 at 10:30 AM in the laboratory revealed the laboratory began documenting room temperature in August 2024. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on record review, the laboratory's procedures, and interview with staff the laboratory failed to establish written policies and procedures for the performance of two of two moderately complex test. a. A review of the CMS-116 revealed the laboratory performed the following moderately complex testing: urine sediments and -- 2 of 3 -- qualitative semen analysis. b. The laboratory was asked to provide written procedures for the performance of urine sediments and qualitative semen analysis. No documentation was provided. c. An interview with the office manager on 8/27/2024 at 12:25 PM in their office confirmed these findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review, the laboratory's policy, and interview with staff the Technical Consultant failed to document competency of 3 of 3 testing personnel in 2022 and 2023. a. A review of the CMS-116 revealed the laboratory performed the following moderately complex testing: urine sediments and qualitative semen analysis. b. A review of the laboratory's Quality Assurance Plan provided by the office manager revealed "PERSONNEL ASSESSMENT ...At least annually the laboratory director and/or technical consultant will review the performance of each employee working in the laboratory to assure employee competency. The written result of the review will be filed in the individual's personnel file. Opportunities will be made available to laboratory personnel for continuing education and noted in the record at the time of this review." c. The laboratory was asked to provide competency assessment for testing personnel that perform moderately complex testing. No documentation was provided. d. An interview with the office manager on 8/27/2024 at 9:41 AM in their office confirmed the laboratory did not perform competency on testing personnel that performed moderately complex testing. -- 3 of 3 --