Radiant Complexions Dermatology Clinic

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 review of the Laboratory Test List and Annual volume form and confirmed by the Chief Operating Officer at approximately 11:10 am on 05/24/2022, the laboratory failed to verify the accuracy for performing potassium hydroxide (KOH) examinations twice annually for five out of five time periods from 01/01/2020 - 05/24 /2022. At the time of the survey, the laboratory did not enroll in proficiency testing for KOH examinations and did not verify the accuracy of the testing by another method from 01/01/2020 - 05/24/2022. THIS IS A REPEAT DEFICIENCY. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient test logs, patient electronic health records (EHR), and 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 -- confirmed by the laboratory's Chief Operating Officer at approximately 11:10 am on 05/24/2022, the laboratory failed to have a system in place to ensure the accurate and reliable transcription of manual test results into the laboratory's EHR for two out of two patients (patient identifier A & B) having potassium hydroxide (KOH) examination testing performed in October 2021. The findings include: 1. Review of the laboratory's KOH log indicated that patient A had a KOH examination performed on 10/01/2021 with a negative result. 2. Patient A's EHR chart showed a result of "positive/negative" for the KOH performed on 10/01/2021. 3. Review of the laboratory's KOH log indicated that patient B had a KOH examination performed on 10/14/2021 with a negative result. 2. Patient B's EHR chart did not include a record of the KOH examination performed on 10/14/2021. 4. At the time of the survey, the laboratory's Chief Operating Officer confirmed that the laboratory did not have a system in place to ensure the accurate and reliable transcription of KOH testing into the EHR. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assurance (QA) policy, lack of QA records, and confirmed by the Chief Operating Officer at approximately 11:30 am on 05/24/2022, the laboratory director failed to ensure that the laboratory established and followed a QA policy that describes the system or process for monitoring the general, pre-analytic, analytic, and post-analytic quality systems as well as define the frequency of QA monitoring. At the time of the survey, the Chief Operating Officer confirmed that the QA policy did not include the process for monitoring the quality systems or the frequency with which they would be monitored. -- 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 review of the Laboratory Test List and Annual volume form, the Quality Assurance procedure and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Form) at approximately 10:45 am on 9/9/2020, the laboratory failed to verify the accuracy for performing potassium hydroxide (KOH) examination and reading Mohs slides twice annually for two out of three time periods from 1/1 /2019 - 9/9/2020. The findings include: 1. The Quality Assurance procedure stated, "Any test performed in the laboratory for which proficiency testing is not available will be verified at least twice a year and results reviewed by laboratory director." 2. On 11/15/2019, the laboratory documented the verification of accuracy for reading Mohs slides. 3. On 5/4/2020, the laboratory documented the verification of accuracy for performing KOH examinations. 4. At the time of the survey, laboratory personnel identifier #3 confirmed the laboratory only verified the accuracy for KOH examinations and reading Mohs slides on the above dates for the time periods between 1/1/2019 - 9/9/2020. 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 3 -- (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 laboratory temperature records and confirmed by laboratory personnel identifier #3 (refer to Laboratory Personnel Report) at approximately 11:00 am on 09/9/2020, the laboratory failed to document the cryostat temperature for one out of two days of patient testing (3/11/2020) in March 2020. The findings include: 1. On 3/11/2020, the laboratory performed Mohs surgery using a cryostat for cutting tissue on Patient identifiers A & B. 2. The laboratory did not document the temperature of the cryostat used for cutting tissue on 3/11/2020. 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) 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 review of quality control records, and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) on 9/9/2020 at approximately 11:00 am, the laboratory failed to document the Hematoxylin and Eosin stain quality each day of patient testing for one out of two days (3/11/2020) in March 2020. The findings include: 1. On 3/11/2020, the laboratory performed Mohs surgery on Patient identifiers A & B. 2. The laboratory did not document the Hematoxylin and Eosin stain quality on 3/11/2020. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate 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 review of personnel records and confirmed by laboratory personnel identifier #3 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 09/09/2020, the laboratory director failed to ensure that prior to testing patient specimens, all testing personnel performing moderate complexity testing received the appropriate training for two out of two testing personnel (identifiers #1 and #2) who perform potassium hydroxide (KOH) examinations. The findings include: 1. Laboratory personnel identifier #1, started performing KOH examinations in May of -- 2 of 3 -- 2020. 2. Laboratory personnel identifier #2, started performing KOH examinations in August of 2020. 3. At the time of the survey, the laboratory did not have documentation of training for either testing personnel. -- 3 of 3 --