Pinnacle Dermatology - Plymouth

Summary Statement of Deficiencies D0000 The Pinnacle Dermatology laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on January 10, 2024. The following standard-level deficiencies were cited: 493.1105 Retention requirements 493.1252 Test systems, equipment, instruments, reagents, materials, and supplies . D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain Histopathology equipment maintenance and quality control records for at least two years for the single Histopathology test performed by the laboratory between November 2021 and August 2022. Findings are as follows: 1. The laboratory performed tissue gross and slide interpretation for Mohs Micrographic surgery under the subspecialty of Histopathology as confirmed by the Histotechnician (HT)) during a tour of the laboratory at 1:05 p.m. on 01/10/24. 2. The previous laboratory director and Mohs surgeon left the practice in August 2022. 3. The retired CLIA Manual, left by the previous laboratory director, did not include the following documentation from November 2021 through August 2022: -Cryostat maintenance records -Microscope maintenance records -Reagent and stain records -Quality control records 4. The laboratory wad unable to locate the missing documentation upon request. 5. In an interview at 2:45 p.m. on 01/10/24, the Laboratory Director confirmed the above finding. . 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 -- 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, document review, and interview with laboratory personnel, the laboratory failed to ensure one of two Histopathology stains were not used after the expiration date had been exceeded in 2024. Findings are as follows: 1. The laboratory performed tissue gross and slide interpretation for Mohs Micrographic surgery under the subspecialty of Histopathology as confirmed by the Histotechnician (HT)) during a tour of the laboratory at 1:05 p.m. on 01/10/24. 2. A Thermo Scientific Linistat slide stainer was observed as in use during the tour. 3. One of two stain bottles stored in the flammable storage cabinet was expired. See below. Vintage Hematoxylin Lot 153142 Expiration date 12/31/23 4. The HT indicated the Hematoxylin stain loaded on the slide stainer was obtained from the expired bottle. 5. The expired Hematoxylin was used to stain slides for eight Mohs patients on 01/03/24 and for nine Mohs patients on 01/10/24 as indicated in the Mohs Lab Case Log and by the HT. 6. In interviews at 1:10 p.m. and 2:35 p.m. on 01/10/24, the HT confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: . Based on observation and interview with laboratory personnel, the laboratory failed to dispose excess Histopathology tissue in accordance with applicable Federal, State, and local requirements from 12/04/19 through 11/16/21. Findings are as follows: 1. The laboratory performed Histopathology testing for Mohs micrographic surgery as confirmed by the Mohs Technician (MT) during a tour of the laboratory at 1:05 p.m. on 11/16/21. 2. Instruction to dispose excess tissue as biohazardous waste according to Federal, State, and local laws was not found in the CLIA Manual procedure book. 3. A biohazard container for excess tissue disposal was not observed in the laboratory during the tour. 4. The laboratory performed an estimated 620 Mohs cases annually as indicated on the CLIA application Form CMS-116 completed on date of survey, 11/16 /21. 5. In an interview at 2:50 p.m. on 11/16/21, the MT confirmed the above finding. 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 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, document review and interview with laboratory personnel, the laboratory failed to document function checks on an integrated digital thermometer. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery under the subspecialty Histopathology as confirmed by the Mohs Technician (MT) during a tour of the laboratory on 12/03/19 at 1:05 p.m. 2. An integrated digital thermometer was observed within the Thermo Scientific Microm HM 520 cryostat. The MT indicated this digital thermometer was used to monitor cryostat temperature each day of use. 3. Function check requirements to verify the accuracy of the digital thermometer were established in the CLIA Laboratory Manual; section 1) Quality Control; part a) Cryostat. 4. Digital thermometer function check documents for 2018 were not found during review of laboratory records. 5. In an interview on 12/03/19 at 3:00 p.m., the MT confirmed the above findings. NOTE: This is a repeat citation from the previous survey 12/5/17. . 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 2 -- (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: . Based on document review and interview with laboratory personnel, the laboratory failed to document all information required for Histopathology quality control records. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery under the subspecialty Histopathology as confirmed by the Mohs Technician (MT) during a tour of the laboratory on 12/03/19 at 1:05 p.m. 2. Requirements for documentation of reagent lot numbers and expiration dates on the Receipt Log was established in the CLIA Laboratory Manual; section 1) Quality Control; part d) Reagents. 3. A reagent Receipt Log was found during review of laboratory records. Reagent lot number and expiration dates were not recorded since December, 2017. 4. In an interview on 12/03/19 at 3:20 p.m., the MT confirmed the above findings. NOTE: This is a repeat citation from the previous survey, 12/5/17. . -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --