Skin Cancer Specialists Pc - Cartersville (Dba)

Summary Statement of Deficiencies D0000 A recertification survey was performed on June 18, 2024. An entrance conference was held with the laboratory representatives. The survey process was discussed, along with review of the survey forms that was sent to the facility, previous to the survey. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficencies, but none were provided. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. 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 the testing personnel (TP) competency records for the period of 2022 - 2024, and TP interview, the technical supervisor failed to ensure all TP had annual competency performed. Findings: 1. Review of TP competency records revealed 4 out of 7 personnel annual competency assessments were incomplete. Review of competency records revealed: - TP1 (CMS 209) incomplete KOH competencies for 2023 and 2024 - TP3 (CMS 209) incomplete KOH competencies for 2023 and 2024 - TP6 (CMS 209) incomplete KOH competencies for 2023 and 2024 - TP7 (CMS 209) incomplete KOH competencies for 2023 and 2024 2. Interview with a Laboratory Histology Technologist on June 18, 2024 at 11:30 am in the breakroom, confirmed the aforementioned 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 D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 06, 2020. 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 an interview with the laboratory manager (TP #8 CMS 209), the laboratory failed to implement and established safety procedure to ensure protection from physical, biochemical, and biohazardous materials. Findings include: 1. During the laboratory tour it was observed that the two fire extinguishers in and around the laboratory area were not inspected annually. Last inspection was July of 2017. 2. An interview with the laboratory manager (TP#8 CMS 209), during the laboratory tour, on 01/06/2020, at approximately 10:25 a.m. confirmed that the fire extinguishers have not been inspected for two and a half (2.5) years. 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. 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: A review of the procedure manual and an interview with the laboratory manager (PT#8 CMS 209), revealed that the laboratory failed to have an adequate Quality Assurance (QA) policy specific to the specialty of Histopathology in 2018 and 2019. Findings include: 1.) Procedure manual review revealed that the clinic does not have an adequate (QA) policy specific to the specialty of Histopathology. 2.) An interview with the laboratory manager (TP #8 CMS209), at approximately at 12:30 pm, on 01/06 /2020 in the break room, confirmed that the clinic did not have an adequate written QA policy specific to Histopathology in 2018 and 2019. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's maintenance, Quality Assurance(QA) records and an interview with the laboratory manager(TP#8 CMS 209), the General Supervisor (GS) and the laboratory director failed to ensure that Monthly (QA) reports and maintenance logs were reviewed and signed in 2018 and 2019. Findings include: 1. Maintenance and Quality Assurance report review revealed QA and maintenance logs were not reviewed and signed in 2018 and 2019 by the Technical Supervisor(TS) or the laboratory director. 2. An interview with the laboratory manager (TP#8 CMS 209) on 01/06/ 2020, at approximately 12:40 pm, in the break room confirmed that maintenance logs and QA reports were not reviewed and signed by the (TS) or the laboratory director. -- 2 of 2 --