Livonia Dermatology

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, record review, and interview with the Mohs Tech (MT), the laboratory failed to ensure staff protection from chemically hazardous materials by not storing hazardous chemical reagents in accordance with the laboratory's policy for 6 of 6 bottles of chemical reagents observed. Findings include: 1. During a tour of the laboratory on 08/06/2025 at 9:30 AM, the surveyor observed the following six (6) bottles of hazardous chemical reagents stored on an open shelf: a. One (1) bottle of Medical Chemical Corporation (MCC) Xylene b. One (1) bottle of Epredia Clarifier c. One (1) bottle of Medline 95% Reagent Grade Alcohol d. One (1) bottle of Epredia 100% Dehydrant e. One (1) bottle of Astral Diagnostics Eosin Y 1% Alcoholic f. One (1) bottle of Gill 3 Hematoxylin 2. A review of the laboratory's policy Standard Operating Procedures, section titled "Hazardous Materials", revealed: a. "ALL HAZARDOUS MATERIALS AND REAGENTS ARE TO BE STORED IN THE FIRE SAFETY CABINET." b. "Current hazardous materials including: 1. Xylene 2. Denatured ethanol (alcohol) 3. Hematoxylin 4. Eosin 5. Mounting medium 6. Isopropyl alcohol 7. Reagent alcohol " 3. An interview conducted with the MT on 08 /06/2025 at 1:10 PM confirmed that hazardous chemical reagents were not stored in the fire safety cabinet as required by laboratory policy. 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 record review and interview with the Mohs Technician (MT), the laboratory failed to verify the accuracy of its testing at least twice annually for Periodic Acid-Schiff (PAS) testing for 3 (of 3 biannual periods reviewed. Findings include: 1. A review of the laboratory's twice annual verification of accuracy documentation revealed lack of documentation of twice-annual verification of accuracy testing for PAS testing during the following periods: a. Second (2nd) biannual period of 2023 b. First (1st) biannual period of 2024 c. Second (2nd) biannual period of 2024 2. On 08/06/2025 at 1:00 PM, a request was made to the MT to review the PAS patient log and confirm the number of patients tested during the above periods. The MT reviewed the log and reported that 19 patients underwent PAS testing during these timeframes. 3. An interview conducted on 08/06/2025 at 1:10 PM, the Mohs Technician (MT) confirmed that verification of accuracy testing for PAS had not been performed for the above periods. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) provide a safe environment in which employees are protected from physical, chemical, and biological hazards; This STANDARD is not met as evidenced by: . Based on record review and interview with the Mohs Tech (MT), the laboratory director failed to notify the Department of Health and Human Services (HHS) and the State Agency (SA) of termination of Periodic Acid-Schiff (PAS) testing after cessation of testing for 9 of 9 months since testing ceased. Findings include: 1. A record review of the laboratory's Quality Control and Maintenance Records revealed that PAS testing was discontinued in November of 2024. 2. As of the date of survey, 08/06/2025, no documentation was available to demonstrate that HHS or the SA had been notified of the termination of PAS testing which exceeds the required six (6) month notification period by three (3) months. Notification requirements at 493.51(c) state laboratories are to notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance. 3. During an interview conducted on 08/06/2025 at 1:30 PM, the Mohs Technician (MT) confirmed that PAS testing was discontinued in November 2024 and that no notification had been made to HHS or the SA. -- 2 of 2 --

Summary Statement of Deficiencies D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to verify the accuracy of its Periodic Acid-Schiff special stain testing at least twice annually (refer to D5217), failed to establish a written procedure for its Periodic Acid-Schiff special stain testing (refer to D5401), and failed to perform and document control procedures for its Periodic Acid-Schiff special stains at least each day of use (refer to D5473). 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 record review and interview with Testing Personnel #2, the laboratory failed to follow its competency assessment policies for 1 (Testing Personnel #2) of 2 testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's personnel records revealed Testing Personnel #2, performing tissue specimen gross examinations, last had their competency assessed on 3/2/22. 2. A review of the laboratory's "Technical Supervisor" policies revealed a section stating, "The technical supervisor is responsible for the technical and scientific oversight of 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 -- the laboratory. The responsibilities are as follows: Evaluate and document performance of individuals responsible for highly complex testing at least semi- annually during the first year they test patient specimens, and then at least annually unless the test methodology and/or instrumentation change." 3. An interview on 7/25 /23 at 12:01 pm with Testing Personnel #2 confirmed their competency assessment had not been completed at least annually according to laboratory policy. 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 record review and interview with Testing Personnel #2, the laboratory failed to verify the accuracy of its Periodic Acid-Schiff special stain testing at least twice annually for 2 (July 2021 to July 2023) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Patient Test Management" policy with a section titled "Testing and Verification" stating, "Four slides (2 cancers, 1 noncancer, 1 PAS) will be sent biannually to an outside laboratory for interpretation." 2. The surveyor requested documentation of the verification of accuracy for its Periodic Acid-Schiff (PAS) special stain testing from July 2021 to July 2023 on 7/25/23 at 11:25 am and it was not made available. 3. An interview on 7/25/23 at 12:01 pm with Testing Personnel #2 confirmed the laboratory had not verified the accuracy of its PAS special stain testing at least twice annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #2, the laboratory failed to establish a written procedure for its Periodic Acid-Schiff special stain testing for 2 (July 2021 to July 2023) of 2 years. Findings include: 1. The surveyor observed Schiff's reagent in the laboratory refrigerator during a tour of the laboratory on 7/25 /23 at 9:20 am. 2. A review of the laboratory's procedure manuals revealed a lack of procedure for the performance of Periodic Acid-Schiff special stain testing. 3. An interview on 7/25/23 at 11:43 am with Testing Personnel #2 confirmed the laboratory had not established a test procedure for its Periodic Acid-Schiff special stain testing. 4. An interview on 7/25/23 at 12:01 pm with Testing Personnel #2 revealed the laboratory had performed PAS special stain testing on 9 patients from January to July 2023. 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 of 3 -- (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 record review and interviews, the laboratory failed to perform and document control procedures for its Periodic Acid-Schiff special stains at least each day of use for 9 of 9 patients tested between January to July 2023. Findings include: 1. An interview on 7/25/23 at 11:25 am with Testing Personnel #2 revealed the laboratory performed Periodic Acid-Schiff (PAS) special staining. 2. An interview on 7/25/23 at 11:40 am with the Laboratory Director revealed positive and negative controls for PAS special staining had not been recorded each day of use. 3. An interview on 7/25/23 at 12:01 pm with Testing Personnel #2 revealed the laboratory had performed PAS special stain testing on 9 patients from January to July 2023 and no positive and negative controls had been documented. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #2, the laboratory failed to issue corrected reports for 3 (Patients DP22-738, MH22-308, and MH23- 134) of 13 patient test reports reviewed. Findings include: 1. A review of patient test records revealed the following patients had errors on their test reports without a corrected report issued: a. Patient DP22-738, testing performed on 4/4/22, indicated the site of "Right Tibial" on the test report with a line drawn through it and "perinasal" handwritten next to it. b. Patient MH22-308, testing performed on 09/20/22, indicated the site of "Left Calf" on the test report with a line drawn through it and "Pretibial" handwritten next to it. c. Patient MH23-134, testing performed on 5/25/23, indicated the site of "Left Clavicle" on the test report with a line drawn through it and "Right Cheek" handwritten next to it. 2. An interview on 7/25/23 at 12:01 pm with Testing Personnel #2 revealed the sites that were changed were corrected and a corrected report had not been issued. -- 3 of 3 --

Summary Statement of Deficiencies 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 Mohs' Technician (MT), the laboratory failed to record the specimen receipt time into the laboratory for the Mohs' tissue specimens for 2 of 12 final Mohs' maps reviewed for 2 years. Findings include: 1. A record review for 2 of 12 final Mohs' maps reviewed in the patients electronic medical record (EMR) system revealed the laboratory did not record the specimen receipt time into the laboratory for the tissue specimen on the Mohs' map as follows: a. specimen MH20-225 - collected on 9/24/2020, no time on stage II b. specimen MH21-327 - collected on 10/14/2021, no time on stage I and II 2. An interview on 11 /10/2021 at 11:09 am, the MT confirmed the final Mohs' maps did not contain the time of receipt into the laboratory for the Mohs' tissue specimens. D5805 TEST REPORT CFR(s): 493.1291(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 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 -- 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 Mohs' Technician (MT), the laboratory failed to ensure the final Mohs' map contained a negative and/or clear margins documentation for 1 (MH21-106) of 12 Mohs' maps reviewed for 2 years. Findings include: 1. A record review of the final Mohs' maps revealed for 1 (MH21- 106) of 12 maps the Mohs' surgeon failed to document negative and/or clear margins on the Mohs' map. 2. An interview on 11/10/2021 at 11:09 am, the MT confirmed the Mohs' map failed to show documentation that the margins were negative and/or clear. -- 2 of 2 --

Summary Statement of Deficiencies D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director and Testing Personnel #2, the laboratory failed to document the time it receives a specimen for 4 (patients #7, #8, #11, and #12) of 12 patient charts reviewed. Findings include: 1. A review of 12 patient charts revealed the following patients had MOHS specimens collected without documentation of the time received by the laboratory for the following patients: a. Patient #7, surgery performed 8/28/19 b. Patient #8, surgery performed 3/14/19 c. Patient #11, surgery performed 4/5/18 d. Patient #12, surgery performed 11/9/17 2. An interview on 10/1/19 at 12:29 pm with the Laboratory Director and Testing Personnel #2 confirmed the above patient specimens did not have the time received by the laboratory documented. 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: 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 Testing Personnel #2, the laboratory failed to monitor humidity for 2 (October 2017 to October 2019) of 2 years. Findings include: 1. An observation on 10/1/19 at 10:05 am by the surveyor revealed the laboratory did not have a humidity monitor. 2. A record review of the Leica Cryostat CM 1850 Operator's Manual revealed a section titled "Site Requirements" stating, "Air humidity must not exceed 60%." 3. An interview on 10/1 /19 at 10:05 am with Testing Personnel #2 confirmed the laboratory was not monitoring humidity. D5805 TEST REPORT CFR(s): 493.1291(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: A. Based on record review and interview with the Laboratory Director and Testing Personnel #2, the laboratory failed to provide positive patient identification for 1 (patient #7) of 12 patient charts reviewed. Findings include: 1. A review of 12 patient charts revealed patient #7 had MOHS surgery performed on 8/28/19. 2. A review of the MOHS map from patient #7 dated 8/28/19 revealed a lack of two patient identifiers. 3. An interview on 10/1/19 at 12:30 pm with the Laboratory Director and Testing Personnel #2 confirmed patient #7 did not have two patient identifiers on the MOHS map. B. Based on record review and interview with the Laboratory Director and Testing Personnel #2, the laboratory failed to indicate the name and address of the laboratory location where testing was performed for 2 (October 2017 to October 2019) of 2 years. Findings include: 1. A review of patient charts revealed MOHS maps without the name and address of the laboratory performing testing. 2. An interview on 10/1/19 at 12:30 pm with the Laboratory Director and Testing Personnel #2 confirmed the name and address were not on the MOHS map in use by the laboratory. -- 2 of 2 --