Pinnacle Dermatology

Summary Statement of Deficiencies 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 the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), the laboratory procedure manual, Mohs data logs, review of testing personnel records and a lack of records, and review of an electronic mail communication, the laboratory failed to follow the policy for performing initial, six-month, and annual competency assessments for two of three testing personnel who performed inking of tissue removed during Mohs micrographic surgical procedures. The findings include: 1. A review of the FORM CMS-209 revealed three testing personnel who inked tissue removed during Mohs micrographic surgery. 2. A review of the procedure titled "POLICY FOR PERSONNEL COMPETENCY" revealed the following: "Personnel must not report test results for patient specimens until training is complete and competency is verified for each test procedure they perform. Competency assessments should occur every six months for the first year and annually thereafter for all testing personnel." 3. A review of Mohs data logs revealed the initials of testing persons three and four (TP3, TP4) as follows: TP3 and TP4 in January 2023, TP4 in February 2023, TP3 in April 2023, and TP3 in July 2023. 4. A review of testing personnel records revealed no documented initial training or six-month competency for TP3 in 2023 and no annual competency assessment for TP4 in 2023. 5. A review of an electronic mail communication with testing person two on 04/19/24 at 12:51 p.m. revealed that competency assessments are not usually performed for the Mohs histotechs that fill in for the full-time histotechs. This confirmed the survey findings. 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 -- D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's twice a year verification of accuracy (alternative proficiency testing) reports and staff interview, the laboratory failed to document review for four of four alternative proficiency testing reports from 2022 and 2023. The findings include: 1. Review of the laboratory's twice a year verification of accuracy (alternative proficiency testing) reports revealed no documented review after the results were received for the following events: January-June 2022, July-December 2022, January-June 2023, July-December 2023. 2. Testing person number two confirmed the findings during interview on 04/12/24 at 10:45 a.m. 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 observation of the laboratory, review of patient Mohs's surgical report, laboratory quality records, and staff interview, the laboratory failed to document the quality assessment of hematoxylin and eosin stain for one of four dates selected from 2022, 2023, and 2024. The findings include: 1. Observation of the laboratory on 04/12 /24 at 8:25 a.m. revealed reagents and equipment used for processing and staining of tissue removed during Mohs micrographic surgery. Stains observed were hematoxylin and eosin (H&E). 2. Review of patient identification number A9236737 revealed Mohs surgical procedure performed on 11/10/2022. 3. Review of the H&E stain quality log revealed no documentation that stain quality was evaluated on 11/10/22. 4. Testing person number two confirmed the survey findings during interview on 04/12 /24 at 10:45 a.m. -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory records and interview with the histotech, the laboratory failed to verify the accuracy of the cryostat temperature recording device in 2020, 2021, and 2022. The finding include: 1. Observation of the laboratory on 05/18/2022 at 9 am revealed a cryostat in use for processing tissue for histopathology procedures, and a thermometer on the counter for monitoring room temperature and humidity. 2. Review of laboratory records revealed an acceptable temperature range of -21 to -30 degrees Celsius for the cryostat, and a room temperature range of 10-30 degrees Celsius. Further review revealed no records were available verifying the accuracy of the cryostat temperature or room temperature recording devices. 3. Interview with the histotech on 05/18/2022 at 11:00 am confirmed the laboratory was recording room temperature using a department store thermometer and recording the temperature of the cryostat with no records verifying the accuracy of the temperature readings in 2020, 2021, and 2022. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) 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 -- (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Citation number one Based on observation of the laboratory, review of patient data log, document request, and interview with the histotech, the laboratory failed to document reagent lot numbers, dates in use, and expiration dates for chemicals, stains and reagents used for performing histopathology procedures from 08/27/2020 to 05/18 /2022. The findings include: 1. Observation of the laboratory on 05/18/2022 at 9:15 am revealed multiple reagents, chemicals, inks, and stains in use for performing histopathology procedures on tissue removed during MOHS procedures. 2. Review of the patient data log revealed the first patient was reported on 08/27/2020. 3. Request on 05/18/2022 at 11 am for reagent records revealed the laboratory did not retain a reagent log to include all reagents in use from the time patient testing began on 08/27 /2020 until the date of the survey (05/18/2022). 4. Interview with the histotech on 05 /18/2022 at 11:30 am confirmed the laboratory failed to document and retain reagent lot numbers, dates of use, and expiration dates of chemicals, stains, inks and reagents in use for performing histopathology procedures from 08/27/2020 until 05/18/2022. Citation number two Based on observation of the laboratory, review of patient data log, document request, and interview with the histotech, the laboratory failed to document hematoxylin and eosin (H&E) stain quality from 02/25/2021 until 12/16 /2021 with approximately 253 patients tested. The findings include: 1. Observation of the laboratory on 05/18/2022 at 9:15 am revealed multiple reagents and stains in use for performing histopathology procedures on tissue removed during MOHS procedures. 2. Request on 05/18/2022 at 11 am for H&E stain quality assessment records revealed the following: No H&E stain quality assessment records were retained for two of four patients selected (CTP21-0016-date tested 03/11/2021) and (CTP21-0164B-tested 10/07/2021). Further review revealed no documentation of H&E stain quality assessment from 02/25/2021 to 12/16/2021 with approximately 253 patients tested. 4. Interview with the histotech on 05/18/2022 at 11:30 am confirmed the laboratory failed to document H&E stain quality from 02/25/2021 until 12/16 /2021 with approximately 253 patients tested. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, review of laboratory records, and interview with the histotech, the laboratory failed to follow the procedure for quarterly quality assessment activities in 2021. The findings include: 1. Review of the laboratory's procedure titled "Quality Assurance Protocol" revealed that quality assessment activities would be performed quarterly using a quality assurance checklist for documentation. 2. Review of the laboratory's quality assessment documentation revealed no quality assessment activities were documented for 2021. 3. Interview with the histotech on 05/18/2022 at 11 am confirmed there was no quarterly quality -- 2 of 3 -- assessment documentation for the calendar year 2021. She further confirmed patient testing was performed on multiple dates in 2021. -- 3 of 3 --