Holland Dermatology

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Registered Nurse (RN), the laboratory failed to monitor room temperature and humidity for specimen processing and histopathology tissue examination for 23 (May 2024 through March 2026) of 23 months reviewed. Findings include: 1. On 03/11/2026 at 9:18 am, during a tour of the laboratory, the surveyor observed that there was no thermo-hygrometer in use to monitor room temperature and humidity in areas where specimen processing and slide examination were performed. 2. On 03/11/2026 at 9:21 am, an interview with the RN confirmed that a thermo-hygrometer was not present in the laboratory and that room temperature and humidity were not monitored in areas where specimen processing and histopathology tissue slide examination were performed since the last survey (May 2024 through March 2026). 3. On 03/11/2026 at 9:22 am, the surveyor requested the manufacturer's instructions for the microscope used for histopathology tissue slide examination; however, no documentation was provided. 4. A review of manufacturer's instructions for the Seiler Clinical Microscope, Model Microlux III, obtained from the manufacturer's website, revealed the following environmental operating requirements: a. Operating Temperature: 50F - 70F (10C - 25C) b. Operating Relative Humidity: 30% - 75% 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 D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: . Based on record review and interview with the Office Manager, the Laboratory Director failed to ensure testing personnel demonstrated the ability to perform histopathology microscopic tissue examinations reliably prior to testing patient specimens for 1 (Testing Personnel #2) of 2 testing personnel listed on Form CMS- 209. Findings include: 1. A review of the laboratory's personnel records on 6/22/22 revealed a lack of documentation that Testing Personnel #2 listed on Form CMS-209 had demonstrated that they can perform all testing operations reliably to provide and report accurate results. 2. A review of 10 patient test records revealed 2 patients (HD22-525 on 5/9/22 and HD22-234A on 2/28/22) had histopathology microscopic tissue examination testing performed by Testing Personnel #2. 3. The surveyor requested documentation showing Testing Personnel #2 had demonstrated they can perform all testing operations reliably to provide and report accurate results on 6/22 /22 at 9:56 am and it was not made available. 4. An interview on 6/22/22 at 10:15 am with the Office Manager confirmed documentation showing Testing Personnel #2 demonstrated that the ability to perform histopathology microscopic tissue examinations reliably prior to patient testing was not available. 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 D5805 TEST REPORT CFR(s): 493.1291(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, the laboratory failed to identify the name and address of the facility performing part of the histopathology gross examination of the tissue slides for nine (#1 - #9) of nine patient charts reviewed in 2016 to 2018. Findings include: 1. On June 27, 2018 at 11:30 AM, record review of the final patient results for nine ( #1 - #9) of nine patient charts audited in 2016 to 2018 did not include the name and address of the facility where the measurements of the gross examination of the microscopic tissue reading was performed. 2. During the interview on June 27, 2018 at 11:30 AM, the laboratory director as listed on the CMS-209 confirmed the final reports did not include the name and address of the testing site where the measurements of the gross examination were 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 --