Pinnacle Dermatology

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory records, interview with Testing Personnel 1 (TP 1), and Mohs surgery patient reports, the laboratory failed to follow written policies and procedures to ensure positive identification and optimum integrity of a patient's specimen from the time of collection of the specimen through completion of testing and reporting of results for one of seven patient cases reviewed for Mohs surgery in 2020 through 2022. Findings Include: 1. Review of seven Mohs surgery patient reports dated: PT 1 - 01/21/2021 PT 2 - 10/14/2021 PT 3 - 10/14/2021 PT 4 - 12/16 /2021 PT 5 - 01/20/2022 (Left Lateral Forehead A) PT 5 - 01/20/2022 (Left Frontal Scalp B) PT 6 - 06/18/2020 2. Review of Mohs map documentation for PT 5 indicated Mohs surgical map DTR22 - 00013 should have two slides marked, "Left Frontal Scalp B" and Mohs surgical map DTR22 - 00017 should have two slides marked, "Left Lateral Forehead A". Date - 01/20/2022 Location - Left Frontal Scalp B Mohs Op Number - DTR22 - 00013 Case Total Number Slides - 2 (4) Date - 01/20/2022 Location - Left Lateral Forehead A Mohs Op Number - DTR22 - 00017 Case Total Number Slides - 2 (5) 3. Review of the requested Mohs surgery case slides for surgical map DTR22 - 00013 (Case Total Number Slides - 2) revealed a total of three slides on file for PT 5 marked: DTR22 - 00013 PT 5 1-20-22 Lateral I U DTR22 - 00013 PT 5 1-20-22 Frontal I IL DTR22 - 00013 PT 5 1-20-22 Frontal I 4. Review of the requested Mohs surgery case slides for surgical map DTR22 - 00017 (Case Total 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 -- Number Slides - 2) revealed a total of one slide on file for PT 5 marked: DTR22 - 00017 PT 5 1-20-22 Lateral I L2 5. On 05/05/2022 at 3:17 pm, TP 1 confirmed one of the four slides for PT 5 was incorrectly labeled. D5603 HISTOPATHOLOGY CFR(s): 493.1273(b)(f) (b) The laboratory must retain stained slides, specimen blocks, and tissue remnants as specified in 493.1105. The remnants of tissue specimens must be maintained in a manner that ensures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis made by an individual qualified under 493.1449(b), (l), or (m). (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of patient documentation, lack of laboratory records, and interview with Testing Personnel (TP 1), the laboratory failed to retain all records and slide preparations for one of seven patient cases reviewed for Mohs surgery in 2020 through 2021. Findings Include: 1. Review of seven Mohs surgery patient reports dated: PT 1 - 01/21/2021 PT 2 - 10/14/2021 PT 3 - 10/14/2021 PT 4 - 12/16/2021 PT 5 - 01/20/2022 (Left Lateral Forehead A) PT 5 - 01/20/2022 (Left Frontal Scalp B) PT 6 - 06/18/2020 2. Review of Mohs map documentation for PT 2 revealed: Date - 10/14 /2021 Location - Left malar Mohs Op Number - DTR 21 104 Case Total Number Slides - 3 (9) 3. Review of the requested Mohs surgery case slides marked DTR 21 0104 revealed a total of two of three reported slides on file for PT 2. 4. On 05/05 /2022, at 2:30 pm, Testing Personnel 1 confirmed the above findings. D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory documentation, interview with Laboratory Director (LD), and Mohs surgery reports, the laboratory failed to monitor, evaluate, and correct identified problems for one of seven cases reviewed for Mohs surgery in 2020 through 2022. (See D5801). 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 -- 2 of 3 -- 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 laboratory documentation, interview with Laboratory Director (LD), and Mohs surgery reports, the laboratory failed to have an adequate system in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry to the final report for one of seven patient cases reviewed for Mohs surgery in 2020 through 2022. Findings Include: 1. Review of seven Mohs surgery patient reports dated: PT 1 - 01/21/2021 PT 2 - 10/14/2021 PT 3 - 10/14/2021 PT 4 - 12/16/2021 PT 5 - 01/20/2022 (Left Lateral Forehead A) PT 5 - 01 /20/2022 (Left Frontal Scalp B) PT 6 - 06/18/2020 2. Review of Mohs Operative Note revealed the laboratory failed to accurately and reliably report the findings of surgery results for PT 1. The Mohs map of PT 1 detailed: STAGE 3 "Superficial budding only" "Plan 5FU post healing" "# Positive 0/1" 3. Review of treatment documentation for Stage 3 Mohs Procedure Details revealed the laboratory failed to accurately relay the surgical results of the Mohs map for PT 1: "Microscopic tumor was found persisting in none of the sections of the specimens." 4. On 05/05/2022 at 3:17 pm, interview with Lab Director confirmed the above findings and no follow-up plan was initiated for PT 1. -- 3 of 3 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with a laboratory representative; the laboratory failed to attest to the routine integration of potassium hydroxide (KOH) proficiency testing (PT) samples in 2019. Findings Include: 1. Microbiology proficiency testing records were reviewed for 2019. 2. American Proficiency Institute (API) records for event 2 of 2019 found the laboratory failed to have attestation documentation to the routine integration of KOH samples by the testing personnel and laboratory director. 3. Interview with the laboratory representative on survey date 7- 23-2019, at 1:45 pm, confirmed the laboratory failed to attest to the routine integration of KOH PT samples for API PT event 2 in 2019. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: A. Based on review of laboratory records and interview with a laboratory representative; the laboratory failed to follow the laboratory's slide labeling procedure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- for Mohs histopathology testing. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure "Mohs Slide Labeling." 2. Review of the "Mohs Slide Labeling" procedure stated for the Decatur, IL office specimen slides will begin with "DT". 3. Review of 22 patient slides for 5 of 5 Mohs cases reviewed found 22 of 22 slides failed to be labeled according to the laboratory procedure. Patient Identification Test Date Slide Quantity P6 06-13-19 8 P7 04-11-19 4 P8 02-14-19 2 P9 10-18-18 4 P10 12-29-17 4 4. Interview with the laboratory representative on 7-23-2019, at 1:45 pm, confirmed the facility failed to follow the slide labeling procedure for Mohs histopathology testing. B. Based on review of laboratory records and interviews with testing personnel #2 (TP#2) and a laboratory representative; the laboratory failed to follow the Mohs histopathology specimen preparation procedure. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the procedure "Mohs Surgery and Specimen Processing Procedure." 2. Review of the "Mohs Surgery and Specimen Processing Procedure" stated Mohs excision and specimen preparation, including the grossing (specifically the inking of the specimen) is performed by the physician. 3. Interview by phone with testing personnel #2, at 12:50 pm, on 7-23-2019, confirmed that the inking of Mohs histopathology specimens is performed by TP#2 and not the Mohs surgeon. 4. Review of 5 of 5 Mohs histopathology cases identified the inking was performed by TP#2. Patient Identification Test Date P6 06-13-19 P7 04-11-19 P8 02-14-19 P9 10-18-18 P10 12-29-17 5. Interview with the laboratory representative on 7-23-2019, at 1:45 pm, confirmed the facility failed to follow the Mohs histopathology surgery and specimen processing procedure. 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: A. Based on direct observation, review of laboratory records, and interview with the laboratory representative; the laboratory failed to perform cryostat maintenance to ensure accurate and reliable test performance for histopathology testing. Findings Include: 1. Direct observation on 7-23-2019, at 11:20 AM, identified an Avantik QS11 cryostat used for Mohs histopathology testing and found it contaminated debris from the cutting of tissue samples though it was not currently in use. 2. Review of the laboratory's "Daily Routine Maintenance" log stated the following: "3. Cryostat will be wiped out with dry gauze to gather excess scrapings, then cleaned appropriately with alcohol." "7. Document that daily maintenance has been completed by initialing daily maintenance log" 3. Review of the laboratory preventative maintenance log, "Daily Routine Maintenance", found the last date of cleaning for the cryostat was on 7- 11-2019, its last date of service for Mohs histopathology testing. 4. On survey date 7- 23-2018, at 1:45 pm, the laboratory representative confirmed the cryostat had not been cleaned as described in the daily routine maintenance log. B. Based on direct observation, review of laboratory records, and interview with the laboratory representative; the laboratory failed to perform microscope maintenance as required to -- 2 of 4 -- ensure accurate and reliable test performance for mycology and pathology testing. Findings Include: 1. Direct observation on 7-23-2019, at 11:20 AM, identified an Olympus BX41 microscope used for Mohs histopathology and KOH preparation testing, which was not covered. 2. Review of the laboratory's policy and procedure manual identified the log, "Daily Microscope Maintenance". 3. The "Daily Microscope Maintenance" log stated the following: "1.The microscope should be covered at the close of every day." 4. On survey date 7-23-2018, at 1:45 pm, the laboratory representative confirmed no cover was available to cover the microscope as described in the daily routine maintenance log. D5781