Dermatology And Skin Cancer Consultants, Pllc

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 laboratory observation, a review of the manufacturer's operator's manuals, a review of laboratory environmental records, patient test reports, and staff interview, the laboratory failed to monitor laboratory humidity readings in 2024 and 2025. The findings include: 1. Laboratory observation on 09/08/25 at 8:15 a.m. revealed an Avantik cryostat, Linistat automated stainer, inks, stains, and reagents used to process tissue removed during Mohs surgery in preparation for slide interpretation. 2. A review of the manufacturer's operator's manual and environmental requirements revealed the following: For the Linistat Automated Stainer, the maximum relative humidity was up to 80%. For the Advantik cryostat, the maximum relative humidity was up to 60%. 3. A review of the laboratory's 2024 and 2025 environmental records revealed no documentation that the laboratory monitored humidity readings. 4. A review of randomly selected test records revealed the following patient case numbers performed during the period when humidity was not monitored: J24-0282 on 04/01 /24, J24-0932 on 11/06/24, J25-205 on 03/05/25, J25-543 on 06/23/25, and J25-758 on 09/04/25. 5. The lead histotech confirmed the survey findings during an interview on 09/08/25 at 10:30 a.m. 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 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 laboratory observation, staff interview, and review of an electronic mail communication, the laboratory failed to ensure expired hematoxylin and eosin stains were not used past the expiration date from 11/11/24 to the date of the survey on 09/08 /25. The findings include: 1. Laboratory observation on 09/08/25 at 8:15 a.m. revealed an Avantik cryostat, Linistat automated stainer, inks, stains, and reagents used to process tissue removed during Mohs surgery in preparation for slide interpretation. During observation, containers of stains were noted that had expired: hematoxylin lot number 2229905, expiration date of 11/10/24, and eosin lot number 2304107, expiration date of 02/21/25. 2. The lead histotech confirmed the expired stains were being used to stain patient tissue during an interview on 09/08/25 at 8:20 a.m. 3. A review of an email received on 09/15/25 at 2:48 p.m. revealed that 811 Mohs surgery patients had slides stained during the period of expired stain use. -- 2 of 2 --

Summary Statement of Deficiencies D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: The laboratory personnel performing high complexity testing did not meet the regulatory education requirement for high complexity testing personnel. (Refer to D6171) 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 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 -- 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 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 observation of the laboratory, interview with the lead histotech, review of personnel records, and interview with the laboratory director, the three personnel performing high complexity testing failed to meet the regulatory education requirements. The findings include: 1. Observation of the laboratory on 04/07/22 at approximately 8:15 am revealed reagents, stains, and inks in use for performing histopathology procedures for MOHS. 2. Interview with the lead histotech on 04/07 /22 at approximately 8:20 am revealed that tissue is brought to the lab by the MOHS surgeon and the histotechs perform inking and mapping of the tissue. 3. Review of testing personnel records revealed the three histotechs did not have the required education to perform high-complexity inking and mapping of the tissue. 4. Interview with the laboratory director on 04/07/22 at approximately 11am confirmed the histotechs did not meet the required regulatory education requirement to perform high- complexity inking and mapping of tissue removed during MOHS procedures. -- 2 of 2 --