Academic Dermatology & Cosmetic Surgery Center

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation and interview with histology technician (HT), the laboratory failed to ensure histopathology reagents were not used beyond expiration date for 1 (red) of 3 reagents observed. Findings include: 1. During a tour of the laboratory on 06 /02/2025 at 10:40 am, the surveyor observed three MOHS tissue stains (1 red, 1 blue, 1 green) dispensed in unlabeled containers. 2. During an interview with the HT on 06 /02/2025 at 10:41 am, when asked to confirm the supply source of the dispensed stains, the HT stated that the red stain bottle had been discarded earlier that morning during setup, as the final portion was used and stated the red stain expired on May 31, 2025. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: 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 -- . Based on observation, record review and interview with the Office Manager (OM), the laboratory failed to establish and follow a preventative maintenance protocol for laboratory equipment for 24 (April 2023 to May 2025) of 24 months reviewed. Findings include: 1. The surveyor conducted a tour of the laboratory at 9:30 am on 6/2 /2025 and observed the following equipment did not have a service tag: a. Microscope: Leicia DM E b. Cryostat: Lecia CM1900 c. Tissue Embedder: Leicia EG1160 2. A review of laboratory records revealed that annual preventative maintenance records were not present for the Microscope, Cryostat and Tissue Embedder. 3. A review of the laboratory's policies and procedures revealed that a maintenance procedure for annual preventative maintenance of laboratory equipment had not been established. 4. An interview with the OM at 11:25 am on 6/2/2025 confirmed that annual preventative maintenance had not been conducted on instruments listed above. 5. A record review of user manuals for the equipment confirmed that annual preventative maintenance was to be performed as follows: a. Microscope: "...professional maintenance every 1-2 years"... b. Cryostat: "...the instrument inspected by a qualified service engineer...once a year." c. Tissue Embedder: "...annual maintenance is recommended..." D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview with the Medical Assistant (MA), the laboratory failed to indicate the laboratory name and address on the patient test report for 3 (10,11,12) of 3 MOHS patient test reports reviewed. Findings include: 1. A record review of MOHS patient test reports revealed the name and address of the laboratory was not listed for the following reports: a. Patient 10: 05/06/2023 b. Patient 11: 04/07/2024 c. Patient 12: 03/13/2025 2. An interview on 06/02/2025 at 11:40am with the MA confirmed the location of the laboratory was not listed on the patient test reports. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, lack of documentation, and interview with the Office Manager and a staff member, the laboratory failed to perform and document the thermometer calibration checks as required by the manufacturer before the expiration for 2 (Digi- Sense) of 2 thermometers in use. Findings include: 1. During a tour of the laboratory on 3/15/2023 at 9:17 am, the surveyor observed a thermometer in the histopathology processing laboratory and another by the microscope in the Laboratory Director's office in use past their expiration dates as follows: a. histopathology lab - S/N 192161185 expired 5/07/2021. b. Laboratory Directors office - S/N 192161221 expired 5/07/2021. 2. A record review of the procedure manual revealed no maintenance procedure for the frequency of thermometer calibrations and/or replacement prior to expiration dates noted on the thermometer. 3. A record reviewed revealed a lack of documentation for the calibration of the 2 thermometers and/or replacement by the expiration dates noted on the serial tags. 4. A interview on 3/15 /2023 at 9:28 am, the Office Manager and a staff member confirmed the 2 thermometers were not calibrated and/or replaced before their expiration. 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 D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: . Based on record review and interview with an Office Staff (OS) member, the laboratory failed to have a written request for patient testing from an authorized person for 1 (#3) of 26 patient charts audited. Findings include: 1. Record review revealed for 1 (#3) of 26 patient charts audited the laboratory did not have a written request for laboratory testing by an authorized person for the potassium hydroxide (KOH) testing completed on 8/21/2020. 2. An interview on 8/19/2021 at 11:07 am, the OS member confirmed the patients paper chart did not contain an order for the KOH testing. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review and interview with an Office Staff (OS) member, the laboratory failed to have the final potassium hydroxide (KOH) testing results maintained as part of the patient's paper chart for 1 (#3) of 26 patient charts reviewed. Findings include: 1. A record review for 1 (#3) of 26 patient charts reviewed revealed 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 -- a lack of documentation in the patient's paper chart for the KOH testing performed on 8/21/2020. 2. An interview on 8/19/2021 at 11:07 am, the OS member confirmed the patient's final KOH test results was not maintained in the patient's paper chart. -- 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 procedure review, record review, and interview with the office manager and a staff member, the laboratory failed to ensure written competency policies were established and implemented that included the six procedural requirements from subpart M for two (August 2017 to August 2019) of two years of mycology testing. Findings include: 1. Procedure review of the "CLIA/Lab Book" revealed the laboratory did not have a competency policy that included the six procedural requirements from subpart M as follows: a. "Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; b. Monitoring the recording and reporting of test results; c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; d. Direct observations of performance of instrument maintenance and function checks; e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and f. Assessment of problem solving skills." 2. Record review of competency assessments revealed a lack of documentation for two (August 2017 to August 2019) of two years for the assessments of the mycology potassium hydroxide (KOH) testing as follows: a. annual testing (2017 - 2019) for testing personnel #1 and #2. b. six month and 12 month (2018) for testing personnel #3. 3. During the interview on August 13, 2019 at 10:35 am, the office manager and office staff member confirmed the "CLIA/Lab Book" lacked a competency policy and a lack of documentation for the assessments for two years for testing personnel #1 - #3. 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 -- D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager and office staff member, the laboratory failed to document the onsite professional interpretation of the hematoxylin & eosin (H&E) differential stain quality for nine (K-65027, K-36235, K- 10455, I-89595, I-41951, I-72703, I-26751, I-09164, and H-96472) of nine dermatopathology cases reviewed. Findings include: 1. Record review from the off- site processing facility revealed the stain quality for positive and negative reactivity of the H & E stain was observed and documented for the dates of the nine random cases reviewed. 2. On August 13, 2019 at 11:10 a.m., the surveyor requested documentation for the on-site H & E stain interpretation for the professional component of the slide review. The lab was unable to provide the surveyor the documentation requested for nine of nine cases reviewed as follows: a. K-65027 b. K-36235 c. K-10455 d. I-89595 e. I-41951 f. I-72703 g. I-26751 h. I-09164 i. H-96472 3. During the interview on August 13, 2019 at 11:10 a.m., the office manager and office staff member confirmed the professional component of the stain quality interpretation was not documented. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager and office staff member, the laboratory failed to maintain a record system that 1) included the case number recorded on the final Mohs' map for ten (17-54, 17-77, 18-05, 18-29, 18-61, 18-96, 19-01, 19-20, 19-37, and 19-58) of ten Mohs' cases and 2) include the specimen receipt time into the laboratory for each stage level of testing for six (17-54, 18-05, 18-29, 18-61, 19-01, and 19-20) of ten Mohs' cases reviewed. Findings include: 1. Record review for ten of ten Mohs' cases reviewed the laboratory failed to include the case identification (ID) number on the final Mohs' map as follows: a. 17- 54 b. 17-77 c. 18-05 d. 18-29 e. 18-61 f. 18-96 g. 19-01 h. 19-20 i. 19-37 j. 19-58 2. Record review for six of ten Mohs' cases reviewed the laboratory failed to include the time of receipt into the laboratory for processing on each stage level on the final Mohs' map as follows: a. 17-54 - no time for levels #1-#3 b. 18-05 - no time for level #2 c. 18-29 - no time for level #2 d. 18-61 - no time for level #2 e. 19-01 - no time for levels #1-#4 f. 19-20 - no time for levels #1-#2 3. During the interview on August 13, -- 2 of 3 -- 2019 at approximately 11:00 a.m., the office manager and office staff member confirmed the final Mohs' map in the patients chart did not contain the Mohs' case ID and stage level receipt times. -- 3 of 3 --