Jackson L Gates Md

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 12, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 Testing Personal (TP) document review and Laboratory Director(LD), the laboratory failed to verify at least twice annually, the accuracy of testing performed for Histopathology. Findings include: 1. TP document review revealed that the LD lacked one peer review for Histopathology in 2020. 2. The LD had one peer review in January 2020, but the report did not have the matching patient slide. 3. During an interview with the LD on January 12, 2022 at 11:35 AM, in the back office, it was confirmed that the LD lacked one peer review for Histopathology in 2020. 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 25, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to establish protection from physical, chemical, and biochemical materials as required. Findings include: 1. Observation during the laboratory tour on 11/25/2019 at approximately 11:20 a.m. revealed the lack of eyewash equipment in the laboratory. 2. An interview with the laboratory director in the laboratory area at approximately 11:20 a.m. on 11/25/2019 confirmed the lack of eyewash equipment in the laboratory. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 observation and staff interview, the laboratory failed to ensure maintenance 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 -- was performed as defined by the manufacturer. Findings include: 1. Observation during the laboratory tour at approximately 11:30 a.m. on 11/25/2019 revealed the Accuscope microscope had not been professionally calibrated in 2018 and 2019 thus far. 2. An interview with the laboratory director in the lab area at approximately 11:30 a.m. on 11/25/2019 confirmed the aforementioned lack of professional microscope calibration. . -- 2 of 2 --