Skinpath Solutions

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 14, 2025. 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: 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 review of the manufacturer's manual, daily log sheets, and interview with the technical supervisor (TS), the lab failed to follow the reference range for Relative humidity (RH%) per the manufacturer's manual. Findings include: 1. Review of the 2023 processing room RH log sheets revealed the lab failed to ensure the recorded RH% was within acceptable limits of 30-85% for 36 of 255 days the lab was in operation. 2. Review of the 2024 processing room RH log sheets revealed the lab failed to ensure the recorded RH% was within acceptable limits of 30 - 85% for 72 of 255 days the lab was in operation. 2. Interview with TS #2 (CMS 209 form) on 1/14 /25 in the conference room at 2:00 PM, confirmed the aforementioned findings. D5785

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 11, 2021. 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: D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on testing personnel (TP) competency document review and laboratory manager's interview, the laboratory director (LD) failed to ensure TP annual competencies were performed by qualified staff as required. Findings include: 1. TP document review revealed annual competencies for TPs# 5 - 8 (CMS 209) were not performed by the Technical Supervisor(TS) who is also the laboratory director (LD) in 2019 and 2020. The competencies were instead performed by non-technical staff. 2. An interview with the laboratory Manager on 03/11/2021 in a conference room at approximately 1:30 p.m. confirmed the aforementioned annual competencies were not performed in 2019 and 2020 by the (TS) who is also the laboratory director. 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 --