Advanced Skin And Mohs Surgery Ctr

Summary Statement of Deficiencies 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: Mohs' . Based on document review and interview with the Office Personnel (OP), the laboratory failed to establish a system to ensure the transcribed Mohs' surgery site were accurately reported in the laboratory information system (LIS) for 3 of 14 Mohs' cases reviewed from December 2019 to December 2021. Findings include: 1. Record review revealed for 3 of 14 Mohs' cases reviewed, the Mohs' surgical site on the Mohs' map and log did not match the location on the final report in the LIS system as follows: a. MS20-137 performed on 7/02/2020 i. Mohs' map and log - left lateral zygoma ii. LIS report - left central malar cheek b. MS21-21 performed on 1/21/2021 i. Mohs' map and log - right inferior medial forehead ii. LIS report - right inferior central forehead c. MS21-55 performed on 3/08/2021 i. Mohs' map and log - right central temple ii. LIS report - right medial temple 2. An interview on 12/06/2021 at 12: 15 pm, the OP confirmed the locations on the LIS report were not consistent with the Mohs' map and log. Frozen Section . Based on record review and interview with the Office Personnel (OP), the laboratory failed to establish a system to ensure the transcribed surgical site and "H&E Permanent Diagnosis" were accurately reported in the laboratory information system (LIS) for 3 of 13 frozen section cases reviewed from December 2019 to December 2021. Findings include: 1. Record review revealed 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 -- for 3 of 13 frozen section cases reviewed, the surgical site and/or the "H&E Permanent Diagnosis" on the frozen section log did not match the location on the final report in the LIS system as follows: a. FS20-4 performed on 1/20/2020 i. frozen section log - right ankle ii. LIS report - right distal pretibial region b. FS20-44 performed on 7/30/2020 i. frozen section log postop diagnosis - Squamous Cell Carcinoma - Invasive ii. LIS report postop diagnosis - Basal Cell Carcinoma c. FS21- 18 performed on 3/08/2021 i. frozen section log - right central temple ii. LIS report - right medial temple 2. An interview on 12/06/2021 at 12:38 pm, the OP confirmed the locations on the LIS report were not consistent with the frozen section log. Potassium Hydroxide (KOH) . Based on record review and interview with the Office Personnel (OP), the laboratory failed to ensure the KOH results were manually transcribed from the "KOH-SCABIES-HAIR MORPHOLOGY" log into the laboratory information system (LIS) for 1 (#6) of 6 patients reviewed from December 2019 to December 2021. Findings include: 1. Record review for 1 of 6 KOH reports revealed the results from the "KOH-SCABIES-HAIR MORPHOLOGY" log did not match the results entered into the LIS system for patient #6 performed on 9/15/2021. The log result is negative and the LIS report is positive. 2. An interview on 12/06/2021 at 1:00 pm, the OP confirmed the results on the KOH log did not match the results entered into the LIS system. -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory failed to label histopathology inks with the identity, storage requirements, and expiration dates for 3 (red, blue, and green) of 3 ink containers observed. Findings include: 1. An observation on 11/14/19 at 10:17 am by the surveyor revealed red, blue, and green inks in small containers without the identity, storage requirements, and expirations dates on each container. 2. An interview on 11/14/19 at 10:17 am with the LD confirmed the laboratory did not have the above information on the histopathology ink containers. 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 --