Southern Cancer Center Pc

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on direct observation during the laboratory tour, a review of electronic history testing records and an interview with the Technical Supervisor (TS), the laboratory failed to ensure in-date Urine test strip was utilized for the patient Urinalysis Test. The surveyor noted 16 of the 100 test strips were left in the container. The findings include: 1. Direct observation of the Consult Diagnostics 10 SG Urine Reagent Strips revealed Lot URS4040066 was utilized for six days to perform patient Urinalysis testing after it had expired on 04-24-2026. 2. During an interview with the TS, the electronic history testing records revealed 17 patients were performed after 04-24- 2026. 3. TS confirmed the above findings during the exit conference on 05-07-2026 at 10:30 AM. D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(c) (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two 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 -- proficiency testing events. This STANDARD is not met as evidenced by: Based on reviews of the API (American Proficiency Institute) Proficiency Testing (PT) records and an interview with the Technical Supervisor (TS), the laboratory failed to ensure PT results were submitted before the due date specified by API. This was noted for one of the three 2025 Immunology PT events. The findings include: 1. A review of the API PT records revealed a score of 0 percent due to "Failure to participate" on the 2025 Immunology Event. 2. TS confirmed the above findings during the exit conference on 05-07-2026 at 10:30 AM. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on reviews of the Sysmex XS-1000i Maintenance Log, the XS-1000i Hematology analyzer Quick Guide and an interview with the Technical Supervisor (TS), the laboratory failed to completely document the monthly or 1200 cycles maintenance as per manufacturer's requirements. The surveyor noted two of the 10 maintenances had no documentation from September 2024 through June 2025. The findings include: 1. A review of the 2024-2026 Sysmex XS-1000i Maintenance Logs revealed a place to document the 1200 cycles maintenance for the analyzer. 2. A further review of the Sysmex XS-1000i Maintenance Logs revealed the following months without documentation of the monthly maintenance. A) September 2024 B) June 2025 3. A review of the Sysmex XS-1000i analyzer Quick Guide revealed the manufacturer's maintenance requirement on page 24, "Monthly Rinse Sequence... Perform monthly or every 1200 samples (cycles)..." 4. TS confirmed the above findings during the exit conference on 05-07-2026 at 10:30 AM. -- 2 of 2 --

Summary Statement of Deficiencies D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Testing Personnel records, the Policy and Procedure manual, and an interview with the Technical Supervisor, the Technical Supervisor failed to evaluate the performance of personnel at least semiannually during the first year of performing testing on the BD FACSCanto II (Flow Cytometry) analyzer. This was noted for one of four Testing Personnel. The findings include: 1. A review of the competency records for Testing Personnel #3 revealed only the initial training for the BD FACSCanto II, dated 05/13/2021. 2. A review of the Policy and Procedure manual revealed the following under a section titled "Quality Assurance", "...Personnel are evaluated semiannually during the first year of employment or when new methodologies are incorporated...". 3. During an interview on 09/07/2022 at 10:30 AM, the Technical Supervisor stated, "[Testing Personnel #3] told me the previous Technical Supervisor never signed off on her six month or yearly competency". D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. 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 a review of Testing Personnel records, the Policy and Procedure manual, and an interview with the Technical Supervisor, the Technical Supervisor failed to evaluate the performance of personnel at least annually after the first year of performing testing on the BD FACSCanto II (Flow Cytometry) analyzer. This was noted for one of four Testing Personnel. The findings include: 1. A review of the competency records for Testing Personnel #3 revealed only the initial training for the BD FACSCanto II, dated 05/13/2021. 2. A review of the Policy and Procedure manual revealed the following under a section titled "Quality Assurance", "...Personnel are evaluated semiannually during the first year of employment or when new methodologies are incorporated. Thereafter, evaluations are performed yearly...". 3. During an interview on 09/07/2022 at 10:30 AM, the Technical Supervisor stated, "[Testing Personnel #3] told me the previous Technical Supervisor never signed off on her six month or yearly competency". -- 2 of 2 --