Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/15/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the histotechnician during an exit conference performed at the conclusion of the survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 a review of records, manufacturer's instructions, and interview with the histotechnician, the laboratory failed to ensure the room temperature had been documented as observed for 12 of 15 months reviewed from October 2022 through the current date. Findings include: (1) On 12/15/2023 at 10:00 am the histotechnician stated the laboratory performed slide interpretation of frozen sections of tissues obtained during Mohs surgical procedures using Leica cryostat and Tissue-Tek Coverslipper; (2) A review of manufacture's instruction manuals identified the following operating environmental requirements: (a) Leica CM 1860 cryostat: i. Temperature range of 18 to 35 degrees C (Centigrade)/64.4 to 95 degrees F (Fahrenheit) (b) Tissue-Tek Coverslipper Model 4764: i. Temperature range of 10 to 30 degrees C )/50 to 86 degrees F (3) A review of the room temperature log from10/24 /2022 through 12/12/2023 identified the following: (a) The acceptable temperature range was defined as 68 to 80 degrees F (b) Although temperatures had been observed 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 -- (denoted by the histotechnician's initials), the actual reading had not been recorded. (4) The records were reviewed with the histotechnician who stated on 12/15/2023 at 11:00 am, the temperatures had not been documented as shown above. 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 a review of records and interview with the histotechnician, the laboratory failed to ensure a patient test report included the address of the laboratory location where the testing was performed for two of two reports reviewed. Findings include: (1) On 12/15/2023 at 10:00 am, the histotechnologist stated the laboratory performed Mohs frozen section and skin biopsies staining using Haematoxylin and Eosin. (2) A review of patient reports identified they did not include the address of the laboratory location where testing was performed for the following: (a) Patient ID # SPL23-226 testing performed on 06/08/2023 (b) Patient ID # SPL23-290 testing performed on 11 /14/2023 (3) The findings were reviewed with the histotechnician who stated on 12/15 /2023 12:00 am, the laboratory address had not been included in the patient test reports. -- 2 of 2 --