Diagnostic Dermatopathology Associates, Llc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on August 19, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D3003 FACILITIES CFR(s): 493.1101(a)(2) (a)(2) Contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: A tour of the laboratory confirmed that the laboratory failed to minimize the risk of cross contamination for patient specimens, equipment, instruments, reagents, materials, and personnel. THE FINDINGS INCLUDE: 1. A tour of the laboratory revealed that a separate clean sink was not available in the clinical laboratory on the date of inspection. 2. A tour of the laboratory revealed that the sink-mounted eyewash station was mounted on the faucet of the dirty sink used for the disposal of biohazard waste. 3. An exit interview, with the LD and the HT, on August 19, 2025, at 11:30am confirmed that the laboratory failed to minimize the risk of cross contamination for patient specimens, equipment, instruments, reagents, materials, and personnel. 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 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 -- 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: A review of 2023 - 2025 Temperature and Humidity Records and a tour of the laboratory confirmed that the laboratory personnel failed to monitor the temperature and humidity in the laboratory to ensure that the manufacturers' required operating environment for the equipment were met. THE FINDINGS INCLUDE: 1. A tour of the laboratory revealed that the there was no thermometer available to monitor the temperature and the humidity in the testing area. 2. A review of the 2023 - 2025 Temperature and Humidity Records confirmed that there were no logs that documented the room temperature or room humidity levels in the testing area. 3. A review of the Leica Bond-Max Stainer, the Tissue-Tek VIP5A Tissue Processor, the Tissue-Tek TEC Embedding Console, Leica AutoStainer XL Stainer revealed an operating temperature requirement of 10C - 35C (50F - 95F) and an operating humidity requirement of 30% - 80%. 4. An exit interview, with the Laboratory Team, on August 19, 2025 , at 11:30am confirmed that laboratory personnel failed to monitor the temperature and humidity in the laboratory to ensure manufacturers' required operating environment for the equipment were met. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Records revealed that the required manufacturer maintenance was not documented and/ or not performed for the Nikon Eclipse microscope, Leica Autostainer XL, Tissue-Tek TEC, Airflotronix Air System, and Captive Aire System. THE FINDINGS INCLUDE: 1. A review of the 2023 - 2025 Maintenance Records confirmed that maintenance records for the Nikon Eclipse microscope, Leica Autostainer XL, Tissue-Tek TEC, Airflotronix Air System, and Captive Aire System were not available at the time of survey. 2. A review of the 2023 - 2025 Maintenance Records and equipment during the tour of the laboratory confirmed that the annual preventive maintenance, required by the manufacturers, were not performed for the following analyzers: a. Nikon Eclipse Microscope required annual maintenance was last performed on July 19, 2023. b. Leica Autostainer XL stainer required annual maintenance was last performed on July 19, 2023. c. Tissue- Tek TEC Embedding Console required annual maintenance was last performed on July 19,2023. d. Tissue-Tek VIP5A Tissue Processor required annual maintenance was last performed on July 19, 2023. e. Captive Aire Air Sysytems required semiannual maintenance was not performed per interview with the Laboratory Director (LD) and Histology Technician (HT). f. The Airflotronix Air System required annual recertification was not performed per interview with LD and HT. 3. An exit interview, with the LD and HT, on August 19, 2025, at 11:30am confirmed that the manufacturer required maintenance was not documented and/ or not performed for the Nikon Eclispe microscope, Leica Autostainer XL, Tissue-Tek TEC, Airflotronix Air System, and Captive Aire System. -- 2 of 3 -- D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Records, 2023 - 2025 Quality Control Records, 2023 - 2025 Temperature Records, and a tour of the laboratory confirmed that Laboratory Director (LD) failed to provide oversight of the administration of the laboratory operations. Refer to D3003, D5413, D5429, D6020 D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Records, 2023 - 2025 Quality Control Records and 2023 - 2025 Temperature Records, confirmed that the Laboratory Director (LD) failed to ensure that the quality control and quality assessment programs were established and maintained to assure the quality of laboratory services provided. THE FINDINGS INCLUDE: 1. A review of the aforementioned 2023 - 2025 records confirmed that the maintenance, quality control, and temperature documentation was not reviewed by the LD to assure the quality services of the laboratory. 2. An exit interview, with the LD and HT, on August 19, 2025, at 11:30am, confirmed that the LD failed to ensure that quality control and quality assessment programs were established and maintained. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 18, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6078 LABORATORY DIRECTOR QUALIFICATIONS CFR(s): 493.1443 The laboratory director must be qualified to manage and direct the laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory director must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b) (1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and (b)(2)(i) Have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (b)(2)(ii) Have at least 2 years of experience directing or supervising high complexity testing; or (b)(3) Hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and-- (b)(3)(i) Be certified and continue to be certified by a board approved by HHS; or (b)(3)(ii) Before February 24, 2003, must have served or be serving as director of a laboratory performing high complexity testing and must have at least-- (b)(3)(ii)(A) Two years of laboratory training or experience, or both; and (b)(3)(ii)(B) Two years of laboratory experience 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 -- directing or supervising high complexity testing. (b)(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or (b)(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or (b)(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification. This STANDARD is not met as evidenced by: Based on review of the Laboratory Director's(LD) License and staff interview, it was determined that the current Laboratory Director's License had expired 12/30/2018. The findings include: 1. Review of the Laboratory State Director's License showed that the license had expired on December 30, 2018. 2. Interview with the LD, on April 18 2019, at approximately 1:50 pm in the reception area of the facility, confirmed that the LD license that he currently had expired on December 30, 2018. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for -- 2 of 3 -- proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on staff interview, during laboratory tour, the histotech stated that she performed gross examination of tissue specimens received in the laboratory for processing, and diagnostic determinations by the Pathologist/Laboratory Director (LD).. Findings: 1. During the laboratory tour, the histotech stated that she performed gross examination of tissue specimens received in the laboratory. 2. Review of the CLIA regulations, and the qualifications of the histotech, it was determined that the histotech does not qualify to perform gross examination of tissue specimens. The laboratory Director was notified by email on April 18, 2019 at 10:21 pm. , that the histotech was not qualified to perform gross examination. 3. The Laboratory Director responded with an email me, on April 30, 2019 at 12:42 pm, to me stating that the histotech, only performed gross examination on tissue shavings, and punch biopsies. The LD attached documentation of the Histotech's qualifications, educations, and training. -- 3 of 3 --