Chattanooga Skin And Cancer Clinic

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Citation Number One: Based on a review of the laboratory's Mohs Quality Assurance policy, the laboratory's Quality Assurance Meeting policy, the laboratory's alternative proficiency testing (PT) records, and staff interviews, the laboratory failed to follow the policies for performing proficiency testing (14 of 18 months in 2023 and 2024). The findings include: 1. A review of the laboratory policy titled "Mohs Quality Assurance" revealed the following procedure: "-1. Ten Mohs cases are randomly pulled by the histotech every month. - 2. Charts and slides will be submitted to the reviewing physician. - 3. Documentation that cases are reviewed is filed within the Mohs Quality Assurance Form. - 4. Any discrepancies identified are further reviewed with the dermatologist and documented on the final diagnosis form. - 5. The data obtained will be reviewed at the Mohs Quality Assurance Meeting." 2. A review of the laboratory policy titled "Mohs Quality Assurance Meeting" revealed the following procedure: "-1. The Mohs Quality Assurance Meeting will take place every 3 months. - 2. Slides are reviewed along with patient records by a pathologist independent from Chattanooga Skin & Cancer Clinic. The slides are reviewed to ensure that Mohs surgical maps are labeled correctly. (Positive margins are actually positive and negative margins are actually negative.)" 3. A review of the laboratory's 2023 and 2024 alternative PT records revealed that the laboratory had not performed PT testing from March 2023 through June 2024 (14 of 18 months reviewed). 4. An interview with the laboratory consultant and histotech on 07/23/2024 at 11:45 a.m. confirmed the survey findings. Citation Number Two: Based on a review of the laboratory's 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 -- Mohs Quality Assurance policy, the laboratory's Quality Assurance Meeting policy, lack of documentation, and staff interviews, the laboratory failed to follow the policies for monitoring proficiency testing in a quarterly Quality Assurance Meeting (6 of 6 meetings in 2023 and 2024). The findings include: 1. A review of the laboratory policy titled "Mohs Quality Assurance" revealed the following procedure: "-1. Ten Mohs cases are randomly pulled by the histotech every month. - 2. Charts and slides will be submitted to the reviewing physician. - 3. Documentation that cases are reviewed is filed within the Mohs Quality Assurance Form. - 4. Any discrepancies identified are further reviewed with the dermatologist and documented on the final diagnosis form. - 5. The data obtained will be reviewed at the Mohs Quality Assurance Meeting." 2. A review of the laboratory policy titled "Mohs Quality Assurance Meeting" revealed the following procedure: "-1. The Mohs Quality Assurance Meeting will take place every 3 months. - 2. Slides are reviewed along with patient records by a pathologist independent from Chattanooga Skin & Cancer Clinic. The slides are reviewed to ensure that Mohs surgical maps are labeled correctly. (Positive margins are actually positive and negative margins are actually negative.)" 3. There were no Quality Assurance Meeting records available for surveyor review for 2023 or 2024 on the date of the survey, 07/23/2024. 4. An interview with the laboratory consultant and histotech on 07/23/2024 at 11:45 a.m. confirmed the survey findings. -- 2 of 2 --

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 observation of the laboratory, review of the laboratory procedure manual, review of the CMS Laboratory Personnel Report (CMS 209 form) and training and competency assessment records for testing personnel, and interview with the lab processing tech, the laboratory failed to establish written policies/procedures to document testing personnel training and competency assessment for performance of Potassium Hydroxide (KOH) in 2022 through survey date of 05.16.2023. The findings include: 1. Observation of the laboratory on May 16, 2023 at approximately 9:00 a.m. revealed a microscope and KOH reagent in use for patient testing. 2. Review of the laboratory procedure manual revealed no policy/procedure for testing personnel training and competency assessment. 3. Review of CMS 209 form and personnel training and competency assessment records revealed no documentation of testing personnel training or competency assessment for 11 of 12 (Testing Persons # 2-12 on CMS 209) testing personnel performing KOH patient testing. 4. Interview with the lab processing tech on May 16, 2023 at approximately 12:45 p.m. confirmed the laboratory failed to establish written policies/procedures to document testing personnel training and competency assessment for performance of KOH patient testing in 2022 through survey date of 05.16.2023 for 11 of 12 testing personnel. 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 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 -- procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory records, and an interview with the lab processing tech, the laboratory failed to verify the accuracy of potassium hydroxide (KOH) examination twice per year in 2021 and 2022. The findings include: 1. Observation of the laboratory on May 16, 2023 at approximately 9:00 a.m. revealed a microscope and KOH reagent in use for patient testing. 2. Review of laboratory verification of accuracy records for KOH revealed verification of accuracy was not performed twice a year in 2021 and 2022. 3. Interview with the lab processing tech on May 16, 2023 at approximately 12:45 p.m. confirmed the laboratory failed to verify the accuracy of KOH testing twice a year in 2021 and 2022. 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's instructions for use manual, environmental records request, and interview with the lab processing tech, the laboratory failed to monitor and document room temperature and room humidity in the area where the cryostat was being used for processing tissue removed during MOHS procedures in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on May 16, 2023 at 9:00 a.m. revealed two Leica CM1950 Cryostats (Serial Numbers: 047742467 and 00000005623) in use for processing tissues removed during MOHS procedures. 2. Review of the manufacturer's instructions for use manual revealed the Leica CM1950 environmental specifications are as follows: -operating temperature: 18 degrees Celsius to 35 degrees Celsius -relative humidity (operation): 20% to 60% 3. Request of environmental records revealed no records for monitoring and documenting room temperature and room humidity available for surveyor review. 4. Interview with the lab processing tech on May 16, 2023 at approximately 9:10 a.m. confirmed the laboratory failed to monitor and document room temperature and room humidity for the use of the Leica CM1950 in 2021, 2022, and 2023. -- 2 of 2 --

Summary Statement of Deficiencies 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 during a tour of the histopathology work area, observing a pungent chemical odor and interview with the Medical Director, the laboratory failed to install a biohazard fume hood to protect against exposure of hazardous chemicals, for the year 2019, 2020 and 2021. Findings include: 1. On October 12, 2021 at approximately 10:00am the histopathology work area was observed and no biohazard fume hood was present in the staining area. 2. There was a also a strong pungent chemical odor, noticed while touring the histopathology area on October 12, 2021 approximately 10:00am. 3. In an interview, on October 12, 2021 at approximately 10: 00am, the Medical Director confirmed the histopathology lab was not equipped with a biohazard fume hood. 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 --