Ou Health Partners Dermatology

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/18/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the clinic manager, regulatory compliance manager, regulatory compliance program manager, and registered nurse at the conclusion of the survey. 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 a review of records, written policies and procedures, and interview with the clinic manager, the laboratory failed to have a written policy to assess the competency of the technical supervisor and technical consultant, based on the position responsibilities as listed in Subpart M, for one of one person. Findings include: (1) A review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the technical supervisor and technical consultant, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of September 2023 through the current date identified competencies, based on job responsibilities, had not been performed as follows: (a) One of one person listed as the technical supervisor (not performed after 09/14/2023); (b) One of one person listed as the technical consultant (not performed after 09/14/2023). (3) The findings were reviewed with the clinic manager who stated on 06/18/2025 at 02:00 pm, a policy had not been written, and competencies had not been performed for the positions as stated above. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- 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 a review of records and interview with the clinic manager, regulatory compliance manager, regulatory compliance program manager, and registered nurse, the laboratory failed to verify the accuracy of two of four test systems at least twice annually during the review period of August 2023 through the current date. Findings include: (1) On 06/18/2025 at 09:20 am, clinic manager, regulatory compliance manager, regulatory compliance program manager, and registered nurse stated the laboratory performed the following: (a) KOH test on skin scraping; (b) Ectoparasites testing. (2) A review of records from August 2023 through the current date identified the testing had not been verified for accuracy at least twice annually; (3) The records were reviewed with the clinic manager, regulatory compliance manager, regulatory compliance program manager, and registered nurse who stated on 06/18/2025 at 03:15 pm, the laboratory had not verified the accuracy of the testing twice annually during the review period. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 a review of written policies and procedures and interview with the clinic manager, registered nurse, and histotechnician, the laboratory failed to have a written procedure for the Mart-1 staining procedure. Findings include: (1) On 06/18/2025 at 09:39 am, the clinic manager, registered nurse and histotechnician stated the laboratory performed Mohs surgical procedures which included Mart-1/Melan-A Immunohistochemical staining for patients with previously diagnosed melanoma; (2) A review of the laboratory policies and procedures identified no evidence of a written procedure for the Mart-1 staining procedure; (3) The findings were reviewed with the clinic manager and registered nurse who stated on 06/19/2025 at 3:08 pm, the laboratory did not have a written procedure. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the clinic manager, regulatory compliance manager, regulatory compliance program manager, and registered nurse, the laboratory failed to ensure patient test reports included the name, as stated on the CLIA certificate and address of the laboratory location where the testing was performed for nine of nine reports reviewed. Findings include: (1) On 06/18/2025 at 09:25 am, the clinic manager, regulatory compliance manager, regulatory compliance program manager, and registered nurse stated the laboratory performed microscopic interpretations of H&E (Hematoxylin and Eosin) stained slides from frozen section of tissues removed during Mohs surgery. The tissue would then be observed microscopically; (2) A review of the following patient reports identified the laboratory name, as stated on the CLIA certificate and address of the laboratory location where testing was performed were not included: (a) Patient # M25-029 testing performed on 01/07/2025 (b) Patient # M25-086 testing performed on 01/20/2025 (c) Patient # M25- 143 testing performed on 01/29/2025 (d) Patient # M25-173 testing performed on 02 /03/2025 (e) Patient # M25-230 testing performed on 02/12/2025 (f) Patient # M25- 286 testing performed on 02/27/2025 (g) Patient # M25-342 testing performed on 03 /10/2025 (h) Patient # M25-426 testing performed on 03/27/2025 (i) Patient # M25- 454 testing performed on 04/02/2025 (3) The findings were reviewed with the clinic manager, regulatory compliance manager, regulatory compliance program manager, and registered nurse, who stated on 06/18/2025 at 04:00 pm, the laboratory name and address had not been included on the patient test reports. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of records and interview with the clinic manager, regulatory compliance manager, regulatory compliance program manager, and registered nurse, the technical consultant failed to ensure personnel performing moderate complexity testing had been evaluated at least annually for six of six testing persons during the review period of 01/01/2024 through the current date. Findings include: (1) A review of personnel records for six persons (testing person #2, testing person #3, testing person #4, testing person #5, testing person #6, and testing person #8) performing moderate complexity testing from 2024 through the current date identified no evidence annual competency evaluations had been performed during the review period; (2) The records were reviewed with the clinic manager, regulatory compliance manager, regulatory compliance program manager, and registered nurse, who stated on 06/18/2025 at 12:24 pm, the annual competency evaluations had not been performed as stated above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/29/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the senior clinical manager, ethics and compliance officer, and Mohs histology technician during an exit conference performed at the conclusion of the survey. 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 a review of records, written policies and procedures, and interview with the Mohs histology technician, the laboratory failed to have a written policy to assess the competencies of the technical consultants, technical supervisors, and general supervisor, based on the position responsibilities as listed in Subpart M, for two of two persons. Findings include: (1) A review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the technical consultants, technical supervisors, and general supervisor, based on position responsibilities, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of August 2021 through the current date identified competencies, based on job responsibilities, had not been performed for two of two persons listed as technical consultants and technical supervisors; and one of two persons listed as general supervisor; (3) The findings were reviewed with the Mohs histology technician who stated on 08/29/2023 at 11:10 am, a policy had not been written and competencies had not been performed as shown above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 records and interview with the Mohs histology technician, the laboratory failed to ensure the temperatures for two of two Leica CM-1850 cryostats were documented three of seven days of patient testing reviewed from 07/15/2022 through 07/27/2023. Findings include: (1) On 08/29/2023 at 09:35 am the Mohs histology technician stated the laboratory performed slide interpretation of frozen sections of tissues obtained during Mohs surgical procedures using two Leica CM- 1850 cryostats (denoted by the laboratory as Cryostat #1 and Cryostat #2) to prepare the specimens; (2) A review of temperature records for patient testing performed from 07/15/2022 through 07/27/2023 identified the temperatures of the cryostats had not been documented three of seven days of patient testing (07/15/2022, 07/19/2022, and 07/22/2022); (3) The records were reviewed with the Mohs histology technician who stated on 08/29/2023 at 12:40 pm, the temperatures had not been documented as shown above. 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 observation and interview with the Mohs histology technician, the laboratory failed to ensure that one of one expired Chlorazol Black E reagent and one of five expired tissue marking dyes were not available for use. Findings include: CHLORAZOL BLACK E (1) On 08/29/2023 at 09:20 am the Mohs histology technician stated KOH (potassium hydroxide) analysis was performed as a PPM (provider performed microscopy) procedure using Chlorazol Black E or KOH reagent; (2) Observation of room 1936, where the testing was performed, identified one bottle of EDM3 Solutions HealthLink Chlorazol Black E reagent, lot #1120 with an expiration date of 04/20/2023 that appeared to be available for use; (3) The findings were reviewed with the Mohs histology technician who stated on 08/29/2023 at 09:30 am, the expired Chlorazol Black E reagent was available for use. GREEN TISSUE MARKING DYE (1) On 08/29/2023 at 09:35 am the Mohs histology technician stated the laboratory performed slide interpretation of frozen sections of tissues obtained during Mohs surgical procedures; (2) Observation of the Mohs laboratory on 09/29 /2023 at 09:37 am identified one bottle of Stat Lab Medical Products Green Tissue Marking Dye, lot #123468 with an expiration date of 06/30/2023 that appeared to be -- 2 of 3 -- available for use; (3) The findings were reviewed with the Mohs histology technician who stated on 08/29/2023 at 09:40 am, the expired Green Tissue Marking Dye was available for use. 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 a review of records, manufacturer's maintenance instructions, and interview with the Mohs histology technician, the laboratory failed to perform the manufacturer's required weekly maintenance procedures for two of two cryostats during the review period of December 2022 through July 2023. Findings include: (1) On 08/29/2023 at 09:35 am the Mohs histology technician stated the laboratory performed slide interpretation of frozen sections of tissues obtained during Mohs surgical procedures using two Leica CM-1850 cryostats (denoted by the laboratory as Cryostat #1 and Cryostat #2) to prepare the specimens; (2) A review of the operator's manuals for the cryostats identified the following: (a) Cryostat #1 - Section 10.31 under "General Maintenance" stated, "Once a Week - Apply a drop of oil to the plastic coupling"; (b) Cryostat #2 - Section 9.31 under "General Maintenance" stated, "Once a Week - Apply a drop of oil to the plastic coupling". (3) A review of maintenance logs for Cryostat #1 and Cryostat #2 from December 2022 through the July 2023 identified the weekly maintenance had not been documented as performed between: (a) 12/02/2022 and 01/04/2023 (b) 01/04/2023 and 02/03/2023 (c) 02/03/2023 and 03 /03/2023 (d) 03/03/2023 and 04/07/2023 (e) 04/07/2023 and 05/05/2023 (f) 05/05 /2023 and 06/02/2023 (g) 06/02/2023 and 07/07/2023 (4) The findings were reviewed with the Mohs histology technician who stated on 08/29/2023 at 11:40 am, the laboratory had been performing the oiling procedure for both cryostats monthly instead of weekly. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/26/2021. The findings were reviewed with the Mohs technician at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records and interview with the Mohs technician, the laboratory failed to verify the accuracy of KOH (Potassium Hydroxide) analysis and Ectoparasite examinations at least twice annually. Findings include: (1) On 07/26/2021 at 09:45 am, the Mohs technician stated to surveyor #1 the laboratory performed KOH analysis and Ectoparasite examinations; (2) Surveyor #2 reviewed records between 05/23/2019 through 07/26/2021, which showed the testing had not been verified for accuracy at least twice annually in 2019, 2020, and 2021; (3) Surveyor #2 reviewed the records with the Mohs technician who stated on 07/26/2022 at 2:25 pm, KOH analysis and Ectoparasite examinations had not been verified for accuracy at least twice annually as indicated above. 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. 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 -- (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 records, manufacturer's instructions, observation, and interview with the laboratory manager, the laboratory failed to ensure materials were stored as required for 5 of 5 months. Findings include: (1) On 07/26/2021 at 10:25 am, the Mohs technician stated to the surveyors the MART-1/Mean-A (Melanoma Marker) Ab-3 (Cocktail) stain was performed in the laboratory beginning 06/19/2020; (2) On 07/26/2021 at 10:40 am, surveyor #2 observed the following stored in the laboratory refrigerator: (a) MART-1/Melan-A Ab-3 stain (3) The Mohs technician stated to surveyor #2 on 07/26/2021 at 10:25 am, MART-1/Mean-A Ab-3 is used as a melanocyte differentiation antigen to recognize cells of melanocytic differentiation and the diagnosis of melanoma; (4) Surveyor #2 reviewed the manufacturer's package insert for the stain. Under "Storage and Stability", the manufacturer stated, "Ab with sodium azide is stable for 24 months when stored at 2-8 C."; (5) Surveyor #2 then reviewed the temperature records from 07/28/2020 through 12/17/2020 and identified the materials were being stored at temperatures colder than 2 degrees C (Celsius) or warmer than 10 degrees C for 8 of 86 days reviewed as follows: (a) July - Days 28,29,30 were documented at temperatures that were colder than 2 degrees C (b) August -Day 18 was documented at a temperature warmer than 10 degrees C (c) October- Day 7 was documented at a temperature colder than 2 degrees C (d) November - Days 21, 23 were documented at temperatures that were colder than 2 degrees C (e) December 0 Day 17 was documented at a temperature colder than 2 degrees C (6) Surveyor #2 reviewed the records with the Mohs technician who stated on 07/26/2021 at 02:40 pm, the refrigerator temperatures were unacceptable for the materials as shown above. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the Mohs technician, the technical consultant failed to ensure evaluations included all moderate complexity testing performed for 6 of 6 testing persons. Findings include: (1) On 07/26/2021 at 09:45 am, the Mohs technician stated to surveyor #1 KOH analysis and Ectoparasite examinations were performed in the laboratory; (2) Surveyor #2 then reviewed personnel records for 6 persons performing KOH examinations and Ectoparasite examinations in the laboratory between 05/23/2019 through 07/26/2021; (3) There was no evidence annual evaluations, performed for the 6 persons, included an assessment of KOH analysis and Ectoparasite examinations; (4) Surveyor #1 reviewed the findings with the Mohs technician, who stated on 07/26/2021 at 02:26 pm the above persons did not have an assessment of KOH analysis and Ectoparasite examinations as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 05/23/19. The laboratory was found to be in compliance with a standard-level deficiency cited. The findings were reviewed with the senior clinic manager and the Mohs histology technician at the conclusion of the survey. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the Mohs histology technician, the laboratory failed to follow the manufacturer's instructions. Findings include: (1) At the beginning of the survey, the Mohs histology technician stated to the surveyor the laboratory performed microscopic examination of frozen sections from tissues obtained during Mohs surgery. The tissue was frozen and cut using two Leica CM1850 Cryostats, then the sections were mounted on slides, dried, stained with H&E (Hematoxylin and Eosin), and interpreted for diagnosis; (2) The surveyor reviewed the laboratory's humidity records from 09/01/17 through 05/23 /19. The laboratory's acceptable humidity range listed on the logs was "20-85%;" (3) The surveyor then reviewed the manufacturer's storage requirements for the cryostats. The manufacturer required a humidity that did not exceed 60%. The surveyor identified the laboratory's acceptable range would allow for humidity to be higher than the manufacturer's specification; (4) The surveyor reviewed the findings with the Mohs histology technician, who stated to the surveyor the laboratory's acceptable humidity range did not meet the manufacturer's specification for humidity. 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 --