Thomas Dermatology

Summary Statement of Deficiencies 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 lack of accuracy verification documentation for Frozen Biopsies and interview with the facility personnel, the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2023. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of Frozen Biopsy testing at least twice annually during 2023. 2. The facility personnel interviewed on 9/26/24 at 11:45 AM confirmed the laboratory failed to verify the accuracy of Frozen Biopsy testing testing at least twice annually during 2023. 3. The laboratory's reported annual test volume for Frozen Biopsy interpretations is 84. 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 lack of temperature records for the room temperature and the cryostat from August 2022 through December 2023 and interview with the facility personnel, the laboratory failed to monitor and document the room temperature where dermatopathology reagents are utilized and stored and failed to monitor and document the temperature of the cryostat used in conjunction with Mohs and Frozen Biopsy testing. Findings include: 1. The laboratory processes specimens and interprets dermatopathology slides in conjunction with Mohs surgery and Frozen Biopsies, with an approximate annual test volume of 1,740. 2. No documentation of the room temperature was presented for review from August 2022 through December 2023, to indicate the laboratory monitored and documented the temperature of the room where dermatopathology reagents are utilized and stored each day of testing. 3. No documentation of the cryostat temperature was presented for review from August 2022 through December 2023, to indicate the laboratory monitored and documented the temperature of the cryostat used on each day of testing. 4. The facility personnel interviewed on 9/26/24 at 12:00 PM confirmed that the laboratory failed to monitor and document the cryostat temperature and the room temperature of the laboratory from August 2022 through December 2023. 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: Based on review of Mohs test reports and Frozen Biopsy test reports maintained in the Electronic Health Record (EHR) and interview with the facility personnel, one out of three Mohs test reports reviewed in the EHR failed to include the final test result and two out of two Frozen Biopsy test reports failed to include the gross description. Findings include: 1. One out of three Mohs test reports (MR# 34468 from 4/24/23) reviewed in the EHR during the survey failed to include the final test result. 2. Two out of two Frozen Biopsy test reports (MR# 53021 from 1/09/24 and #40982 from 4 /16/24) reviewed in the EHR failed to include the gross description. 3. The facility personnel interviewed on 9/26/24 at 11:35 AM confirmed the test reports indicated above failed to include the final test result for Mohs and failed to include the gross description, respectively. 4. The laboratory's reported annual test volume under the subspecialty of Histopathology is 1,740. -- 2 of 2 --

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on lack of histopathology slides for review, review of pathology test report and interview with the facility personnel, the laboratory failed to retain histopathology slides for at least 10 years from the date of examination. Findings include: 1. The laboratory performs the microscopic interpretation of frozen biopsies, with an approximate annual test volume of 48. 2. The laboratory failed to produce evidence of the histopathology slide from the frozen biopsy performed on October 6, 2020 for MR# MM0000012573. 3. During the survey conducted on August 22, 2022 at approximately 10:40am, the facility personnel stated that the slide for the frozen biopsy indicated above could not be located. 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 lack of accuracy verification documentation for review and interview with 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 facility personnel, the laboratory failed to verify the accuracy of testing performed under the sub-specialty of Histopathology at least twice annually during 2020 and 2021. Findings include: 1. No documentation was presented for review during the survey conducted on August 22, 2022 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading/diagnosis) of Mohs specimens at least twice annually during 2020 and 2021. 2. No documentation was presented for review during the survey conducted on August 22, 2022 to indicate the laboratory verified the accuracy of the microscopic interpretation (reading/diagnosis) of Frozen Biopsy specimens at least twice annually during 2020 and 2021. 3. The facility personnel interviewed on 8/22/22 at approximately 10:25am confirmed that the laboratory failed to verify the accuracy of the histopathology testing indicated above at least twice annually during 2020 and 2021. 4. The laboratory performs approximately 360 Mohs tests and 48 Frozen Biopsies annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of quality assessment (QA) policies and interview with the facility personnel, the laboratory failed to monitor, assess and correct problems identified in the general laboratory systems. Findings include: 1. The laboratory performs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 408. 2. The laboratory's established policy QA policy presented for review failed to include information to monitor, assess and when indicated, correct problems identified with the verification of accuracy process for Mohs and Frozen Biospy testing. See D5217 for specific findings. 3. No other QA documentation was presented for review during the survey to indicate the laboratory monitored the verification of accuracy process during 2020 and 2021. 4. The facility personnel confirmed that the laboratory's QA processes failed to monitor, assess and correct problems identified in the general laboratory systems, which include problems related to the performance of the verification of accuracy. 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 review of the laboratory's microscope maintenance policy and interview with the facility personnel, the laboratory failed to document the annual preventative -- 2 of 3 -- maintenance of the microscope used in patient testing under the sub-specialty of Histopathology. Findings include: 1. During the survey conducted on August 22, 2022, no documentation was presented for review from 2020 and 2021 to indicate the laboratory performed and documented annual preventative maintenance on the microscope used for reading patient slides. 2. The facility personnel acknowledged that there was no documentation of annual preventative maintenance from 2020 and 2021 for the microscope used by the laboratory to read patient slides under the sub- specialty of Histopathology 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: Based on review of the laboratory's pathology test reports for Frozen Biopsy interpretations performed in 2020 and interview with the facility personnel, the laboratory failed to include the gross description on the test report reviewed during the survey. Findings include: 1. The laboratory performs Frozen Biopsy interpretations, including the gross description, under the sub-specialty of Histopathology, with an approximate annual test volume of 48. 2. During the survey conducted on August 22, 2022, one out of one pathology test reports reviewed [MR# MM000012573, from 10 /06/20] failed to include the gross description. 3. The gross description (including weighing, measuring, describing color, specific orientation for diagnostic interpretation, and other characteristics of the tissue) must be included on the pathology test report. 4. The facility personnel confirmed that the biopsy test report reviewed during the survey failed to include the gross description as described above. -- 3 of 3 --