Kayal Dermatology And Skin Cancer

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 25, 2024. 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: 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) document review and staff interview, the laboratory failed to document quality assessment activities on a monthly basis as stated in their QA policy manual in 2022 and 2023. Findings: 1. A review of the laboratory QA documents revealed the technical supervisor (TS) did not review and sign monthly quality activity checklists from May 2022 thru December 2023 in the Specialty of Histopathology. 2. A review of daily maintenance logs including: Room Temperature, Humidity, Cryostat, Eye Wash and Refrigerator logs were not reviewed and signed by the Laboratory Director (LD) or General Supervisor (GS) from May 2022 thru December 2023. 3. Interviews with the GS (TP#2 CMS 209) and office manager on 01/25/2024, at approximately 12:35 pm in the review room confirmed the above laboratory logs and QA checklists were not reviewed and signed by the GS or LD from May 2022 thru December 2023. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) 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 -- (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 and interview with the technical supervisor, the laboratory failed to ensure the performance of training, semi-annual and annual competency assessments were completed for testing personnel (TPs) performing Potassium Hydroxide (PPM - KOH) testing in 2022 and 2023. Finding: 1. A review of laboratory training and competency records failed to identify the training/competency assessments for Provider Performance Microscopy (PPM) (KOH) prep for skin fungal identification for (TPs #s 3 - 6 CMS 209) in 2022 or 2023. 2.There was no peer review performed twice annually or proficiency testing (PT) from a CMS approved agency to test the competency of PPM testing personnel. 3. An interview with the General Supervisor (GS) and office manager, in the review room, at approximately 1: 00 PM, on 01/25/2024 confirmed the abscence of training records and competencies for (TPs #s 3 - 6 CMS 209) in 2022 or 2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 28, 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 staff interview, the laboratory failed to observe safety procedures to ensure protection from physical, chemical, and electrical hazards as required. Findings include: 1. Observation during the laboratory tour and subsequent office tour on 2/28/2020 at approximately 11:30 a.m. revealed all three fire extinguishers in the facility were last inspected on 9/06/2017. 2. An interview with the lead histotech in the laboratory on 2/28/2020 at approximately 11:45 a.m. confirmed al three fire extinguishers in the facility were last inspected on 9/06/2017. 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 personnel (TP) document review and staff interview, the laboratory 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 -- failed to verify twice annually the accuracy of any unregulated test or procedure it performs as required. Findings include: 1. Based on TP document review, the laboratory failed to have available at the time of survey 2018 twice annual peer review documents for Staff #5 (CMS 209). 2. An interview with the lead histotech in the laboratory on 2/28/2020 at approximately 11:45 a.m. confirmed the lack of 2018 twice annual peer reviews for Staff #5 (CMS 209). -- 2 of 2 --