Lighthouse Dermatology & Skin Cancer Specialists

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 record review and interview with the laboratory director (LD), the laboratory failed to implement the competency assessment policy for 15 (May 2025 - September 2026) of 15 months. Findings include: 1. A review of the laboratory's policies and procedures revealed that a competency assessment policy was not included. 2. During an interview on September 11, 2026, at 12:45 PM, the surveyor requested the competency assessment policy and none was provided. The LD confirmed that the competency assessment policy was not available. ***This is a repeat deficiency from 5/29/2025.*** D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: . Based on record review and interview with the laboratory director (LD), the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess general laboratory systems for 15 (May 2025 - 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 -- September 2026) of 15 months reviewed. Findings include: 1. A review of the laboratory's quality assessment documentation revealed that written policies and procedures describing the ongoing mechanism used to monitor, assess, and, when indicated, correct problems identified through the laboratory's general laboratory systems quality monitors were not available. 2. A review of the Laboratory Director Quarterly Checklist for QA revealed that the laboratory had not established written procedures describing how identified quality problems would be evaluated, corrected, and reassessed for effectiveness. 3. During an interview on September 11, 2026, at 12: 45 PM, the surveyor requested the laboratory's written Quality Assessment policy and procedures. The LD confirmed that the requested documentation was not available. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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 record review and interview with the laboratory director (LD), the laboratory failed to establish a competency assessment policy for personnel (LD) for 2 (April 2025 to May 2025) of 2 months reviewed. Findings include: 1. A review of the laboratory policies and procedures revealed a lack of a competency assessment policy. 2. An interview with the LD on May 29, 2025, at 1:15 pm confirmed that a competency assessment policy had not been developed. 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 with the Laboratory Director (LD), the 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 -- laboratory failed to indicate the required demographic information on the patient test report for 9 (1-9) of 9 patients reviewed. Findings include: 1. A record review of 9 patient test reports revealed the following demographic information was missing from the patient test report: a. Patient name or unique identifier b. Name and address of the laboratory location c. Test report date d. Test performed e. Specimen Source f. Test Result g. Laboratory Director signature 2. A record review of patient reports missing the above demographic information are as follows: a. Patient 1: 04/01/2025 b. Patient 2: 04/04/2025 c. Patient 3: 04/30/2025 d. Patient 4: 05/07/2025 e. Patient 5: 05/12 /2025 f. Patient 6: 05/14/2025 g. Patient 7: 05/16/2025 h. Patient 8: 05/19/2025 i. Patient 9: 05/22/2025 3. An interview on 05/29/2025 at 1:15 pm with the LD confirmed the demographics were missing on the patient test reports. -- 2 of 2 --