Advanced Dermatology And Skin Cancer Assoc, Pllc

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, review of the Centers and Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS 209) and staff interview, the laboratory failed to have a policy/procedure for assessing testing personnel competency. The findings include: 1. The laboratory procedure manual did not have procedures for assessing testing personnel competency. 2. A review of Form CMS 209 revealed that one testing person, in addition to the laboratory director, interpreted histopathology slides. 3. The office manager confirmed the laboratory did not have procedures to assess testing personnel competency during an interview on 05/20/24 at 11:00 a.m. 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 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 observation of the laboratory, review of the manufacturer instruction manuals, review of the laboratory procedure manual, patient records, the Centers for Medicare & Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), lack of records and staff interview, the laboratory failed to monitor humidity in the area where the Advantik QS12 cryostat and Linistat stainer was in use for processing patient tissue removed during Mohs procedures in 2021, 2022, and 2023 with approximately 300 patient cases performed annually, and failed to define temperature ranges for the use of the cryostat. The findings include: 1. Observation of the laboratory on 05/15/23 at 8:10 am revealed the Advantik QS12 cryostat and Linistat stainer in use for processing patient tissue removed during Mohs surgery. 2. Review of the manufacturer's instruction manuals revealed the following operating environmental conditions: Advantik QS12 Relative Humidity Maximum of 60% up to 35C Linistat Stainer Relative Humidity Maximum of 80% up to 31C. Decreasing linearly to 50% at 40C 3. Review of the laboratory's procedure manual revealed discrepancies between the acceptable temperature for the cryostat. The cryostat maintenance procedure indicated to maintain temperature of -22 to -30C; the quality control policy indicated a 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 -- temperature range of -20 to -30C, the Mohs procedure indicated a cryostat temperature of -24 to -29C. 4. Review of randomly selected patient cases revealed testing performed on 04/26/21 - case #908, 05/09/22 - case #1211, 10/10/22 - case# 1323, and 03/27/23 - case #1471. 5. Review of the Form CMS-116 revealed the laboratory performs approximately 300 Mohs cases per year. 6. There were no records documenting monitoring of humidity for 2021, 2022, or 2023. 7. Interview with the lead histotech on 05/15/23 at 10:45 am confirmed the laboratory did not monitor humidity in the area where the Advantik QS12 cryostat and Linistat stainer were being used to process patient tissue removed during Mohs surgical procedures in 2021, 2022, and 2023 with patient testing performed. She also confirmed the laboratory did not clearly define the acceptable temperature range to use for the Advantik QS12 cryostat. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be avai and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written pr for testing or examining specimens. This STANDARD is not met as evidenced by: Citation #1 Based on review of the laboratory's procedure manual, the document titled "Quality Control Stain patient log for MOHS procedure and interview with the laboratory director, the laboratory failed to follow po documentation of daily quality control for 14 of 22 days in 2017 and 2018. The findings include: 1. Review o laboratory's Quality Assurance procedure revealed the following statement: "The first case submitted to the m which consists of NORMAL tissue will be stained for H&E, documented on the control sheet as the QA. 2. R the document titled "Quality Control Staining" revealed Quality Control Staining recorded on dates 9-25-17, 6-17, 12-4-17, 1-8-18, 2-5-18, 3-5-18 and 4-2-18. 3. Review of the patient log for MOHS procedure revealed testing on 9-25-17, 10-2-17, 10-16-17, 10-23-17, 10-30-17, 11-6-17, 11-13-17, 11-20-17, 11-27-17, 12-4-17, 12-18-17, 1-8-18, 1-15-18, 1-22-18, 1-29-18, 2-5-18, 2-12-18, 2-26-18, 3-5-18, 3-19-18, and 4-2-18. 4. Interv the laboratory director via phone on 4-9-18 at 12:15 pm confirmed the laboratory failed to follow policy for documentation of daily quality control staining for 14 of 22 days in 2017 and 2018. ________________________________________________________________________________________ Citation #2 Based on review of the laboratory's procedure titled "KOH Mount", review of the document titled patient test report numbers 1, 2, and 3, and interview with the laboratory director, the laboratory failed to foll procedure for performance of Potassium Hydroxide (KOH) when test was performed and reported by testing number two, not the laboratory director in 2017. The findings include: 1. Review of the laboratory's procedur "KOH Mount" revealed the following statement under the section titled Examination: "Slide is then examined microscopy by lab director. Lab director then confirms negative/positive results. Results documented by lab d patient's electronic medical record." 2. Review of the document titled KOH log revealed the performance of K 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 -- testing personnel number two (not the laboratory director) for 6 of 8 KOH tests performed in 2017. 3. Review patient test reports (patients #1, 2, and 3) revealed the electronic signature of testing personnel number two (n laboratory director). 4. Interview via phone on 04-09-18 at 12:15 pm with the laboratory director confirmed t laboratory failed to follow policy for KOH when KOH testing was performed by testing personnel number tw of the laboratory director in 2017. -- 2 of 2 --