Hamblin Dermatology Pllc

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 Mohs testing 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 Mohs testing at least twice annually during 2023. 2. The facility personnel interviewed on 9/25/24 at 2:15 PM confirmed the laboratory failed to verify the accuracy of Mohs testing at least twice annually during 2023. 3. The laboratory's reported annual test volume in the subspecialty of Histopathology is 636. 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 lack of established quality assessment (QA) policies and procedures and interview with the facility personnel, the laboratory failed to establish policies and procedures to monitor, assess and correct problems identified in the general laboratory 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 -- systems requirements specified at 493.1231 through 493.1236. Findings include: 1. No QA documentation was provided for review during the survey conducted on 9/25 /2024 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the general laboratory system requirements specified at 493.1231 through 493.1236, including but not limited to, Proficiency Testing and/or accuracy verification policies and procedures. 2. The facility personnel interviewed on 9/25/2024 at 2:20 PM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the general laboratory systems requirements. 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 lack of humidity records for review from 2022, 2023 and 2024, review of the manufacturer's specifications for the Advantik QS12 Cryostat and interview with the facility personnel, the laboratory failed to monitor and document the ambient humidity of the room where the cryostat is utilized. Findings include: 1. The laboratory utilizes the Advantik QS12 Cryostat in conjunction with Mohs testing under the subspecialty of Histopathology with an annual test volume of 636. 2. The manufacturer's specifications for the Advantik QS12 Cryostat reviewed during the survey listed an operating relative humidity range of 0%-60%. 3. The laboratory failed to provide documention demonstrating the ambient humidity of the room where the cryostat is utilized was monitored and recorded on each day of patient testing from 2022 through 2024 (through the survey date of 9/25/2024). 4. The facility personnel interviewed on 9/25/2024 at 2:00 PM confirmed the laboratory failed to monitor and document the ambient humidity as indicated above. -- 2 of 2 --

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 review and interview with 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 November 1, 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. The facility personnel interviewed on 11 /01/22 at approximately 11:30am confirmed that the laboratory failed to verify the accuracy of the histopathology testing indicated above at least twice annually during 2020 and 2021. 3. The laboratory performs approximately 443 Mohs tests 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 the laboratory's accuracy verification records and interview with the facility personnel, the laboratory failed to identify and correct errors found within 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 -- the accuracy verification process. Findings include: 1. The laboratory performs the microscopic examination and diagnosis on tissue specimens in conjunction with Mohs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 443. 2. It is the practice of the laboratory to randomly select two completed Mohs cases each year which are reviewed by another qualified Mohs physician to verify accuracy of the testing. The review is documented on the "TC/PC Quality Assurance Peer Review Requisition" form. The form contains check boxes labeled, 'Agree' or 'Disagree', where the reviewing physician marks the findings of the review. 3. Review of the TC/PC Quality Assurance Peer Review Requisition form from 2/26 /20 for case# 010-20 failed to indicate whether or not the reviewer agreed or disagreed with the final diagnosis. 4. The laboratory failed to review the results generated from the accuracy verification process indicated above to determine if the verification results were correctly documented and to determine if

Summary Statement of Deficiencies 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 Mohs cases sent out for review for 2018 accuracy assessment and interview with the facility personnel, the laboratory failed to have accuracy assessments performed specific to Mohs surgery slide reading. Findings include: 1. The accuracy checks for two out of two cases (#075-18 and #151-18) submitted to an outside laboratory for review indicated "BCC Present" by the reviewing laboratory's pathologist. 2. The reviewing pathologist was assessing the pathology seen initially, instead of indicating the stage that the margins were clear for the Mohs surgery slide reading. 3. The facility personnel acknowledged that there was no policy or procedure that instructed the reviewing laboratory on the specifics of what to review for the accuracy assessment. 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 D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory manual presented during the survey and interview with the facility personnel, the laboratory failed to have a procedure manual that was approved, signed, and dated by the current laboratory director. Findings include: 1. The laboratory's procedure manual presented for review during the survey conducted on January 25, 2018 failed to include the approval, signature and date of the laboratory director. The laboratory began patient testing on January 5, 2017. 2. The facility personnel acknowledged that the procedure manual was not signed and dated by the laboratory director at the time 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 review of the laboratory's room temperature logs and interview with the 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 -- facility personnel, the laboratory failed to define the criteria for the room temperature. Findings include: 1. The laboratory performs Mohs surgery slide interpretation with an annual test volume of approximately 300. The laboratory began patient testing on January 5, 2017. 2. The laboratory documented the room temperature where the staining reagents are stored and utilized for Mohs slide processing, but there was no policy or indication that a room temperature range had been established. 3. The facility personnel confirmed that the laboratory had not established a room temperature range. 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 Cryostat maintenance policy and interview with the facility personnel, the laboratory failed to indicate the frequency of specific routine maintenance activities. Findings include: 1. The laboratory's established policy titled, "Equipment Quality Control for Microscopes" failed to specify the frequency of the maintenance activities listed in the procedure, including cleaning the stage and ocular eye pieces and performing a grounding check. The procedure also failed to indicate the laboratory's specific protocol for dealing with a nonfunctioning microscope. 2. The laboratory's established policy titled, "Equipment Quality Control for Cryostats" failed to specify the frequency of the maintenance activities listed in the procedure, including cleaning, defrosting, checking the thermometer and performing preventative maintenance and grounding checks. The procedure also failed to indicate the frequency of how often to check the cryostat for proper functioning in laboratory's protocol for dealing with a nonfunctioning microscope. 3. The facility personnel acknowledged that the maintenance procedures indicated above failed to include specific information regarding the frequency of maintenance activities. 4. The microscope and cryostat are used to read and process patient specimens for Mohs testing. -- 2 of 2 --