Lux Dermatology

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on September 24, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedures, a random review of the biannual quality assessment reports from January 2023 through August 2024, and an interview with the office manager, the laboratory failed to follow the director approved policy to ensure positive patient identification and specimen integrity. Findings include: 1. A review of the director approved policy titled "Mohs Surgery Procedure," states that "Date, accession number, patient name, date of birth, site of tissue removal, total number of slides/levels processed, Mohs surgeon, and Mohs technician initials are written on the Mohs Surgery Patient Log." 2. A review of the Mohs Surgery Patient Log from May 16, 2024 through July 11, 2024 found that eight out of 13 date of birth were not documented. 3. A review of the Mohs Surgery Patient Log from May 16, 2024 through July 11, 2024 found that two out 13 initials for the Mohs technician were not documented. 4. A review of the director approved policy titled "Mohs Surgery Procedure," states that "Slides are labeled with the accession number, patient name and second patient identifier, stage and level, site/location, and date of surgery." Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 5. A review of the slides included in the "Quality Assessment Checklist" from April 2023, patients with the accession numbers 23-20, 23-22, and 23-23, were only labeled with the stage. The laboratory failed to include the level per the laboratory's policy. 6. A review of the slides included in the "Quality Assessment Checklist" from January 2024 through June 2024, patients with the accession numbers 24-048 and 24-053, were only labeled with the stage. The laboratory failed to include the level per the laboratory's policy. 7. A review of the slides included in the "Quality Assessment Checklist" from April 2023, found that the patient with the accession number 23-19, had a date of birth recorded on the slide as 2/22/1965. The patient's correct date of birth is 4/19/1954. 8. An interview with the office manager confirmed these findings on September 24, 2024 at approximately 10:00 AM. The laboratory performs approximately 300 histopathology tests annually. 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 a review of laboratory records from January 2023 through August 2024 and an interview with the office manager, the laboratory failed to correctly document the temperature and humidity on Mohs surgery days. Findings include: 1. A review of the "Mohs Surgery Patient Log" indicated that Mohs surgery was performed on May 16, 2024. 2. A review of the "Room Temperature and Humidity Log," found that the laboratory failed to document the room temperature and humidity on May 16, 2024. 3. A review of the "Room Temperature and Humidity Log," found that the laboratory documented the room temperature and humidity on May 18, 2024 when no Mohs surgery was performed. 4. An interview with the office manager confirmed these findings on September 24, 2024 at approximately 10:00 AM. The laboratory performs 300 histopatholoy tests annually. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory records from January 2023 through August 2024 and an interview with the office manager, the laboratory failed to document reagent checks and quality controls (QC) for all dates of Mohs surgery. Findings include: 1. A review of the "Mohs Surgery Patient Log" indicated that Mohs surgery was performed -- 2 of 3 -- on May 16, 2024. 2. A review of the "Mohs Quality Control Log," found that the laboratory failed to document the QC on May 16, 2024. 3. A review of the "Mohs Reagent Log," found that the laboratory failed to document the reagent check on May 16, 2024. 4. An interview with the office manager confirmed these findings on September 24, 2024 at approximately 10:00 AM. The laboratory performs 300 histopatholoy tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on 1/10/2023. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on review of the Reagent Log, observation, and an interview with the laboratory manager, the laboratory failed to document the reagent check for the hematoxylin and eosin stains each day of patient testing. Findings include: 1. Review of the Reagent Log revealed that there was no documentation of the reagent lot numbers and expiration dates for the hematoxylin and eosin stains during 2021 and 2022. 2. No hematoxylin or eosin stains were available in the lab to verify expiration dates. 3. The laboratory manager indicated the Mohs technician brought the stains when they were on site and verified that the reagent lot numbers and expiration dates were to be recorded each day of Mohs procedures in an interview on 1/10/2021 at approximately 11:45 PM. The laboratory performs approximately 300 histopathology tests per year. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) 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 -- (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the patient testing records, Staining Reagent Procedure and Log, and an interview with the laboratory manager, the laboratory failed to document the reagent check for the hematoxylin and eosin stains each day of patient testing. Findings include: 1. Review of patient testing records revealed that Mohs procedures were performed on 3/18/2021, 4/24/2021, 7/2/2021, 9/17/2021, 10/15/2021, and 12/22 /2021. 2. Review of the Staining Reagent Procedure and Log revealed that there was no documentation of the quality control for the hematoxylin and eosin stains on 7/2 /2021, 9/17/2021, and 10/15/2021. 3. The laboratory manager confirmed these findings in an interview on 1/10/2021 at approximately 11:45 PM. The laboratory performs approximately 300 histopathology tests per year. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA initial certification survey conducted at your facility on 6/22/2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 laboratory's Cryostat Temperature and Maintenance Procedure and Log and interview with the Regional Director, the laboratory failed to document the cryostat temperature each day of use as required by the procedure. Findings include: 1. A review of the Cryostat Temperature and Maintenance Procedure and Log from March to June 2021 revealed that the laboratory did not record the cryostat temperatures for the days Mohs procedures were performed in the laboratory on 3/19 /2021 and 4/24/2021. 2. A cryostat temperature record was dated for 3/18/2021 and no temperature was recorded for 4/21/2021. 3. The Regional Director confirmed the finding during the on-site survey on 6/22/2021 at approximately 10:30 AM. The laboratory performs approximately 300 histopathology tests annually. 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 -- D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's Mohs Quality Control Log and interview with the Regional Director, the laboratory failed to document the quality control results. Findings include: 1. A review of the Mohs Quality Control Log from March to June 2021 revealed that the laboratory failed to document the hematoxylin and eosin (H&E) stain results on the two days Mohs surgeries were performed, on 3/19/2021 and 4/24/2021. The columns to indicate "Pass/Fail" were left blank on the quality control log sheet. 2. The Regional Director confirmed the finding during the on-site survey on 6/22/2021 at approximately 10:45 AM. The laboratory performs approximately 300 histopathology tests annually. 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 temperature, maintenance, and quality control logs and interview with the Regional Director, the laboratory director failed to ensure that the quality assessment program was maintained to ensure the quality of the laboratory services. Findings include: 1. Review of the laboratory's Cryostat Temperature and Maintenance Procedure and Log and Mohs Quality Control Log from March to June 2021 revealed that temperature, maintenance and H&E stain records were not documented each day that Mohs surgeries were performed on 3/19 /2021 and 4/24/2021. 2. The laboratory director signed off on the log sheets on 12/14 /2020 and there was no indication of further review of the log sheets by the laboratory director. 3. The Regional Director confirmed the findings during the on-site survey on 6/22/2021 at approximately 10:45 AM. The laboratory performs approximately 300 histopathology tests annually. -- 2 of 2 --