Woodlands Dermatology Associates, The

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 03/19/2026. The laboratory was found in substantial compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. However, the laboratory failed to notify State Agency of address/location change (form Suite 310 to Suite 100) within the required 30 days as per requirement 493.39(b). STANDARD LEVEL DEFICIENCIES were also cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, twice-annual test accuracy verification records and staff interview, the laboratory failed to document twice- annual test accuracy verification for two of two events in 2025. Findings included: 1. Review of laboratory's policy "Proficiency Testing" (last revised 04/30/2024) revealed: "Semi-annually in January and July the tech or Risk Manager will send ten cases from the prior semester containing the original slides, label it with only the surgical case number, and send it out for microscopic examination by a Board Certified Dermatopathologist." 2. Review of laboratory's twice-annual test accuracy verification records revealed facility's "Proficiency Testing 2025 I" and "Proficiency Testing 2025 II" events were both signed by an external Board-Certified Dermatopathologist on 03/04/2026. It was unclear when the slides were sent for review, and there were no other 2025 twice-annual test accuracy verification records available for review. 3. In an interview on 03/19/2026 at 0925 hours at an empty nurses' station in the hallway, the Laboratory Director (as indicated on submitted Form CMS -209) confirmed the findings. 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 -- D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures and twice-annual test accuracy verification records, the laboratory failed to document evaluation of twice-annual test accuracy verification results for two of two events in 2025. Findings included: 1. Review of laboratory's policy "Proficiency Testing" (last revised 04/30/2024) revealed: "Upon receipt of pathology report from the pathologist, diagnosis of the slide specimen will be matched to the in-house diagnosis by the physician." The policy did not address the necessity for documentation of evaluation for result acceptability of the twice-annual test accuracy verification by laboratory director of designee. 2. Review of laboratory's twice-annual test accuracy verification records after survey exit revealed facility's "Proficiency Testing 2025 I" and "Proficiency Testing 2025 II" events did not have documentation of whether the laboratory's twice- annual test accuracy verification results were acceptable, nor any documentation that the laboratory director or designee evaluated the overall performance of the laboratory's participation in twice-annual test accuracy verification. 3. The Laboratory Director (as indicated on submitted Form CMS -209) was notified of this finding on 03 /23/2026 at 1000 hours via email. 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 review of a random laboratory's final patient report and staff interview, the laboratory failed to ensure correct address was included on patient's final report for one of one random patient report reviewed from March 2026. Findings included: 1. In an interview on 03/19/2026 at 0900 hours in the building's entryway, the Laboratory Director stated that the laboratory moved to Suite 100, the current location, in January of 2026. 2. Review of a random laboratory's final patient report from March 2026 for case accession number WD26-2377 revealed the performing laboratory's address contained the old suite number, "Suite 310", instead of the current "Suite 100". 3. In an interview on 03/19/2026 at 1050 hours at an empty nurses' station in the hallway, the Laboratory Director (as indicated on submitted Form CMS -209), after reviewing the report, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 04/30/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). STANDARD LEVEL DEFICIENCIES were cited. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on surveyor's observations, review of laboratory's temperature/humidity logs, policies/procedures and staff interview, the laboratory failed to define and monitor slides/tissue blocks storage conditions to ensure proper preservation for one of one room with slide/block storage. Findings included: 1. Surveyor's observations on 04/30 /2024 at 0930 hours in the facility revealed tissue blocks and slides were stored in the office. 2. Review of laboratory's temperature/humidity logs revealed the laboratory did not have documentation of monitoring slide storage conditions in the office. 3. Review of laboratory's policies/procedures revealed the laboratory did not have a protocol in place defining the storage conditions (temperature/humidity) for tissue blocks/slides. 4. In an interview on 04/30/2024 at 0930 hours in the office, the Laboratory Director (as indicated on submitted form CMS 209) confirmed the findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory's twice annual test accuracy verification records, policies/procedures and staff interview, the laboratory failed to document two of two twice annual test accuracy verifications for 2023. Findings included: 1. Review of laboratory's twice annual test accuracy verification records for 2022, 2023 and 2024 revealed there were no test accuracy verification events documented in 2023. 2. Review of laboratory's policy/procedure "Proficiency Testing" (last modified 05/01 /2023) revealed: "... annually, the tech or Risk Manager will send ten cases containing the original slides, label it (sic) with only the surgical case number, and send it out for a microscopic examination by a Board Certified Pathologists." 3. In an interview on 04 /30/2024 at 0830 hours in the office, the Laboratory Director (as indicated on submitted form CMS 209) confirmed the findings. 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: Based on review of laboratory's microscope maintenance records from January 2023 through April 2024, manufacturer instructions for use and staff interview, the laboratory failed to document microscope maintenance for four of four months in 2024, January through April. Findings included: 1. Review of laboratory's microscope maintenance records revealed the following microscope maintenance was required by the laboratory: "1. The microscope should be covered at the close of every day 2. Take extra care to keep stage of the microscope clean 3. Wipe eye pieces and lenses with lens cloth 4. Change bulbs as needed and have regular service contracts performed 5. Document daily, monthly care." 2. Review of laboratory's microscope maintenance records from January 2023 through April 2024 revealed there was no documentation of microscope maintenance for the following four months: January 2024 February 2024 March 2024 April 2024 3. The laboratory was asked to provide manufacturer instructions for use for its Olympus BH-2 microscope, and no such document was available for review prior to survey exit. 4. In an interview on 04/30 /2024 at 0915 hours in the office, the Laboratory Director (as indicated on submitted form CMS 209) confirmed the findings. Key: CMS - Centers for Medicare and Medicaid -- 2 of 2 --