Skin Cancer & Dermatology Institute-Sparks

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on August 27, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of the laboratory refrigerator and freezer logs from March 2024 through July 2024, observation of the refrigerators used for reagent storage and an interview with the Clinical Research Manager, the laboratory failed to correctly indicate that two refrigerators were utilized by the laboratory so that the devices could be used according to the manufacturer's instructions. Findings include: 1. A review of the laboratory refrigerator and freezer logs from March 2024 through July 2024 found that the log contained a "refrig" column and a "freezer" column. Both columns had documented temperature recordings on the log. The temperatures documented in the freezer column were outside of the acceptable temperature range for a freezer. 2. Observation of the reagent storage area on August 27, 2024, found that there were two mini-refrigerators stacked on each other and available for use. 3. In an interview at approximately 10:00 AM, on August 27, 2024, one of the laboratory personnel indicated that the upper refrigerator was recorded in the "freezer" column and was used for laboratory supplies, including stains for histopathology. The lower Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- refrigerator (with temperatures recorded in the "refrig" column) was used for pharmaceuticals. 4. The manufacturer did not indicate that either mini-refrigerator could be used as a freezer. The documented acceptable temperature range for the freezer was 5 degrees Fahrenheit or 15 degrees Celsius or colder. The mini- refrigerator for laboratory supplies was unable to reach these temperatures. The recorded temperature range was between approximately 28 and 40 degrees Fahrenheit. 5. An interview with the Clinical Research Manager on August 27, 2024, at approximately 10:30 AM confirmed these findings. The laboratory performs approximately 1,000 histopathology tests annually. 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 random review of six Moh's patient files and the associated laboratory logs from April 2023 through July 2024, a review of the temperature logs for the reagent storage refrigerator, and an interview with the Clinical Research Manager found the laboratory failed to define acceptable room temperatures for the Mohs laboratory from May 2024 through July 2024 and failed to define consistent acceptable temperature ranges for the freezer. Findings include: 1. A random review of six Moh's patient files and the associated laboratory logs from April 2023 through July 2024 found that there was no acceptable room temperature documented on the "Mohs Lab Daily/Weekly Maintenance" logs from May 2024 through July 2024, making it impossible to determine if the room temperatures were acceptable for testing. 2. A review of the laboratory refrigerator and freezer logs from March 2024 through July 2024 found that the acceptable temperature ranges were inconsistent between Fahrenheit and Celsius for the freezer. The acceptable range in Fahrenheit was "less than 5 degrees." The range is Celsius was "less than 15 degrees". Five degrees Fahrenheit is equivalent to -15 degrees Celsius. 3. An interview with the Clinical Research Manager on August 27, 2024, at approximately 10:30 AM confirmed these findings. The laboratory performs approximately 1,000 histopathology tests annually. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the testing supplies available during a walk-through of the facility on August 27, 2024, at approximately 11:00 AM, and an interview with the Clinical Research Manager, the laboratory failed to ensure that testing supplies -- 2 of 5 -- available for use were not expired. Findings include: 1. During a walk-through of the facility on August 27, 2024 at approximately 11:00 AM, it was observed that the bottle of potassium hydroxide (KOH) available for testing (lot number: 2131) had expired on May 11, 2024. 2. An interview with the Clinical Research Manager on August 27, 2024, at approximately 11:00 AM confirmed these findings. The laboratory performs approximately 25 mycology tests annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a random review of six Moh's patient files and the associated laboratory logs from April 2023 through July 2024, and an interview with the Clinical Research Manager, the laboratory failed to document monthly maintenance for the cryostat as defined by the manufacturer. Findings include: 1. A random review of six Moh's patient files and the associated laboratory logs from April 2023 through July 2024, found the laboratory failed to document defrosting and cleaning the cryostat during the month of April 2023 on the "Mohs Lab Daily/Weekly Maintenance" logs. 2. The manufacturer's instructions for the cryostat indicate that the cryostat should be defrosted and cleaned at least once per month if the machine receives less than daily use. 3. A review of the April 2023 "Mohs Lab Daily/Weekly Maintenance" logs found that Mohs testing had been performed on 12 out of 20 business days. 4. An interview with the Clinical Research Manager on August 27, 2024, at approximately 11:00 AM confirmed these findings. The laboratory performs approximately 1,000 histopathology tests annually. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random review of six Moh's patient files and the associated laboratory logs from April 2023 through July 2024, and an interview with the Clinical Research Manager, the laboratory failed to document quality controls for the Mohs slides on April 14, 2023. Findings include: 1. A random review of six Moh's patient files and the associated laboratory logs from April 2023 through July 2024, found the laboratory failed to document quality controls for the Mohs slides on the "Q.C. MOHS H&E Quality Documentation Chart" for April 14, 2023. 2. A review of the accession logs found that testing for a patient with the Mohs case number MS23-265 had been performed on April 14, 2023. 3. An interview with the Clinical Research Manager on August 27, 2024, at approximately 11:00 AM confirmed these findings. The laboratory performs approximately 1,000 histopathology tests annually. -- 3 of 5 -- D5785

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA initial certification survey conducted at your facility on February 25, 2019. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the Mohs accession log, Mohs maps, slides and the electronic medical records, and interview with the laboratory manager, the laboratory failed to follow policies and procedures to ensure positive identification of a patient's specimen from collection to final report. Findings include: 1. A sample survey of six random Mohs cases from 12/19/18 to 2/06/19 revealed that for case, #MS19-01, one of two slides was labeled with the wrong date of service. The case information on the Mohs accession log and Mohs map matched the information in the patient's electronic medical record. 2. The laboratory manager interviewed during the on-site survey on 2 /25/19 at approximately 2:15 PM confirmed the finding and stated that the Mohs technician performs an internal audit of the case to ensure that the identifiers are accurate before filing the case. The laboratory performs approximately 180 histopathology tests annually. 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 --