Dermatology & Laser Center Of Oklahoma

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/27/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director and the testing person during an exit conference performed at the conclusion of the survey. 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 testing person #2, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 10/27/2023 at 09:17 am, identified the following expired supplies that appeared to be available for use: (a) Three bottles of CoverSeal-T Toluene Mounting Medium - lot # 96431 with an expiration date of 06/2022; (b) One bottle of CDI Tissue Marking Dye - Violet - lot # 20325 with an expiration date of 11/30/2022. (2) Interview with testing person #2 on 10/25/2023 at 10:02 am confirmed the expired supplies were available for use. 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 D0000 The recertification survey was performed on 10/14/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director at the conclusion of the survey. 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 histotechnologist and laboratory director, the laboratory failed to verify the accuracy of slide interpretations at least twice annually. Findings include: (1) On 10/14/2021 at 09:40 am, the histotechnologist stated to the surveyor, the laboratory performed microscopic interpretations of H&E (Hematoxylin and Eosin) stained slides from procedures on dermatologic biopsies and tissues removed during Mohs surgery. The tissue would then be observed microscopically; (2) The surveyor reviewed records for testing performed from July 2019 through the day of the survey (10/14/2021) and identified the accuracy of the slide interpretations had not been verified twice annually. The interpretations had not been verified for accuracy between 07/30/2019 and 11/10 /2020; (3) The surveyor reviewed the records with the laboratory director who stated on 10/14/2021 at 11:25 am the slide interpretations had not been verified for accuracy twice annually as shown above. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate 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 -- training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the billing and credentialing specialist and histotechnologist, the laboratory director failed to ensure a testing person had the appropriate training for performing grossing for Mohs surgical procedures. Findings include: (1) On 10/14/2021 at 09:40 am, the histotechnologist stated the following to the surveyor: (a) The laboratory performed microscopic interpretations of H&E (Hematoxylin and Eosin) stained slides from procedures on dermatologic biopsies and tissues removed during Mohs surgery. The tissue would then be observed microscopically; (b) The grossing portion of the procedure (measurement, inking, mapping) was performed by the histotechnologist, who was hired to perform the testing in July 2021. (2) The surveyor reviewed personnel records for the histotechnologist and could not locate documented training; (3) The surveyor reviewed the findings with the billing and credentialing specialist and histotechnologist. Both stated on 10/14/2021 at 09:50 am, that although training had been performed for the histotechnologist, it had not been documented. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 08/20/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, office manager, and the histotechnician at the conclusion of the survey. 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 records and interview with the histotechnician, the laboratory failed to ensure the cryostat was maintained at an acceptable temperature. Findings include: (1) At the beginning of the survey, the histotechnician stated to the surveyor the laboratory performed microscopic interpretation of H&E (Hematoxylin and Eosin) slides from frozen sections from tissues obtained during Mohs surgeries and biopsies. The sections were cut using the Avantik QS11 and the Avantik QS12 cryostats; (2) The surveyor reviewed temperature records from 10/30/17 through 08/20/19. The defined acceptable cryostat temperature range, as stated on the monthly record, was -18 to -30 degrees C (Centigrade). The surveyor identified cryostat temperatures which were colder than the acceptable range. The findings follow: (a) Avantik QS11: The temperature was -31 degrees C on 3 of the 69 days of patient testing: (i) 12/18/17 (ii) 03/06/18 (iii) 12/04/18 (b) Avantik QS12: The temperature was -31 degrees C on 7 of the 164 days of patient testing: (i) 01/23/18 (ii) 02/05/18 (iii) 08/20/18 (iv) 12/13 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- /18 (v) 02/33/19 (vi) 04/30/19 (vii) 07/25/19 (3) The surveyor reviewed the findings with the histotechnician who stated to the surveyor the laboratory failed to ensure the cryostat temperatures were acceptable, as listed above. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of records, written policy, manufacturer's instructions, and interview with the histotechnician, the laboratory failed to perform the manufacturer's required maintenance procedures. Findings include: (1) At the beginning of the survey, the histotechnician stated to the surveyor the laboratory performed microscopic interpretation of H&E (Hematoxylin and Eosin) slides of frozen sections from tissues obtained during Mohs surgeries and biopsies. The sections were cut using the Avantik QS11 and the Avantik QS12 cryostats; (2) The surveyor reviewed the manufacturer's maintenance instructions for the cryostats. The manufacturer required the following maintenance procedures be performed at "regular intervals" but did not define the frequency at which they were to be performed: (a) Avantik QS11: (i) Clean the cooling lamella (b) Avantik QS12: (i) Clean the cooling lamella (ii) Clean the touch screen (iii) Disinfect the blade carrier (3) The surveyor then reviewed the laboratory's written policy. The policy stated, "On the day of equipment use, proper functioning of the cryostat will be evaluated and recorded in the the 'Cryostat Routine Maintenance Record Log'." The policy did not define the frequency at which the cleaning and disinfecting procedures were to be performed on the cryostats; (4) The surveyor reviewed the maintenance records for the cryostats from 10/30/17 through 08 /20/19. There was no documentation the maintenance procedures listed above had been performed on days of patient testing during the review period. The findings follow: (a) Avantik QS11: On 69 days of use: (i) October 2017 - On 1 of 1 day used: Day 31 (ii) November 2017 - On 2 of 2 days used: Days 6,27 (iii) December 2017 - On 3 of 3 days used: Days 12,18,19 (iv) January 2018 - On 4 of 4 days used: Days 4,5,8,9 (v) April 2018 - On 2 of 2 days used: Days 24,30 (vi) May 2018 - On 8 of 8 days used: Days 8,14,15,21,22,23,29,31 (vii) June 2018 - On 5 of 5 days used: Days 4,5,11,12,19 (viii) July 2018 - On 3 of 3 days used: Days 2,9,10 (ix) August 2018 - On 2 of 2 days used: Days 7,13 (x) September 2018 - On 2 of 2 days used: Days 20,24 (xi) October 2018 - On 1 of 1 day used: Day 22 (xii) January 2019 - On 4 of 4 days used: Days 4,7,22,29 (xiii) March 2019 - On 1 of 1 day used: Day 12 (xiv) April 2019 - On 1 of 1 day used: Day 2 (xv) May 2019 - On 7 of 7 days used: Days 7,13,14,20,21,28,30 (xvi) June 2019 - On 6 of 6 days used: Days 3,4,5,10,11,18 (xvii) July 2019 - On 11 of 11 days used: Days 8,9,10,12,15,16,18,23,25,29,30 (xviii) August 2019 - On 6 of 6 days used: Days 6,8,12,13,19,20 (b) Avantik QS12: On 164 days of use: (i) October 2017 - On 2 of 2 days used: Days 30,31 (ii) November 2017 - On 8 of 8 days used: Days 6.7,13,14,20,21,27,28 (iii) December 2017 - On 6 of 6 days used: Days 4,5,11,12,18,19 (iv) January 2018 - On 9 of 9 days used: Days 4,5,8,9,16,18,19,22,23 (v) February 2018 - On 7 of 7 days used: Days -- 2 of 4 -- 5,6,12,13,19,27,28 (vi) March 2018 - On 8 of 8 days used: Days 2,5,6,12,13,16,26,27 (vii) April 2018 - On 10 of 10 days used: Days 2,3,9,10,16,17,20,23,24,30 (viii) May 2018 - On 11 of 11 days used: Days 1,7,8,14,15,21,22,23,24,29,31 (ix) June 2018 - On 8 of 8 days used: Days 4,5,11,12,18,19,25,26 (x) July 2018 - On 7 of 7 days used: Days 2,9,10,16,17,23,24 (xi) August 2018 - On 9 of 9 days used: Days 7,8,13,14,20,21,22,27,28 (xii) September 2018 - On 9 of 9 days used: Days 4,6,10,11,17,18,20,24,25 (xiii) October 2018 - On 9 of 9 days used: Days 1,2,15,16,22,23,29,30,31 (xiv) November 2018 - On 10 of 10 days used: Days 5,6,12,13,15,19,20,26,27,29 (xv) December 2018 - On 7 of 7 days used: Days 3,4,10,11,13,17,18 (xvi) January 2019 - On 12 of 12 days used: Days 3,4,7,8,14,15,17,22,24,28,29,30 (xvii) February 2019 - On 8 of 8 days used: Days 4,5,7,11,12,25,26,27 (xviii) March 2019 - On 8 of 8 days used: Days 4,5,7,11,12,25,26,29 (xix) April 2019 - On 11 of 11 days used: Days 1,2,8,9,15,16,22,23,24,29,30 (xx) May 2019 - On 4 of 4 days used: Days 6,7,21,28 (xxi) July 2019 - On 1 of 1 day used: Day 8 (5) The surveyor asked the histotechnician how often the cryostat maintenance listed above was performed. The histotechnician stated to the surveyor cleaning was performed daily and the cooling lamellas were cleaned as needed but performance of the maintenance procedures had not been documented; (6) The surveyor reviewed the findings with the histotechnician and explained the frequency at which the cleaning and disinfecting procedures were to be performed must be defined in the laboratory's written policy, and the performance of the maintenance procedures must be documented. D5781