Palm Harbor Dermatology Pa Dba Dermatolgy

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Palm Harbor Dermatology, PA on 9/8/2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview it was determined one (Patient 3) of three patients ' (Patient 1, 2, and 3) Histopathology reports failed to indicate the name and address of the laboratory location where the test was performed. Findings included: 1. The laboratory provided MOHS map results for three patient results. (Patients 1, 2, and 3). One of three patient reports for Histopathology reports reviewed ( Patient 3) failed to indicate which of the listed nine laboratories. The Visit Notes with the testing results for Patient 3 of the three reviewed (Patient 1, 2, and 3) listed the testing address location of a different laboratory. 2. The Operational Lead, on 9/8/2026 at 1: 00 PM, confirmed Patient 3's MOHS map and Visit Notes both did not indicate the correct name and address of where the testing was performed. 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 D0000 An announced CLIA recertification survey was conducted at Dermatology of Coastal Sarasota on 05/11/22. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director, the laboratory failed to ensure quality control (QC) for hematoxylin and eosin (H&E) stains were documented and acceptable before reporting patient results from 12/19/19 - 05/11/22. Findings included: Record review of the Daily QC Worksheets for H&E stains revealed no documentation to indicate if the control slides were acceptable or not acceptable for 22 (09/29/20, 10/08/20, 10/15/20, 10/22/20, 11/05/20, 11/12/20, 11/19 /20, 12/3/20, 12/10/20, 12/17/20, 10/21/21, 01/13/22, 01/20/22, 01/27/22, 02/17/22, 02 /24/22, 03/10/22, 03/17/22, 03/24/22, 04/07/22, 04/21/22, and 05/05/22) out of 105 days from 12/19/19 through 05/11/22. Review of the laboratory procedure titled Quality Control Measure for Modified Hematoxylin & Eosin Routine Stain revealed "A quality control slide will be performed every day that the stain is placed into use. The Mohs [micrographically oriented histographic surgery] surgeon will review the slide in order to evaluate the stain quality." On 05/11/22 at 11:10 AM, the Laboratory Director stated the testing personnel were implying that the H&E QC was acceptable when approving the "Daily QC Worksheet" even though it was not documented. 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 --