Curcio Dermatology, Pc

Summary Statement of Deficiencies 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 laboratory observation, patient test records, and staff interviews, the laboratory failed to ensure that it did not use four of four lots of tissue marking dyes beyond their expiration in micrographically oriented histographic surgery (MOHS) histopathology patient testing in 2023 and 2024. The findings include: 1. Observation of the laboratory on 09/16/2024 at 8:45 a.m. revealed the following opened Mercedes Scientific tissue marking dyes: - Green (lot: 21327) with an expiration date of 11/30 /2023 - Yellow (lot: 21336) with an expiration date of 12/31/2023 - Red (lot: 21334 ) with an expiration date of 11/30/2023 - Blue (lot: 21299) with an expiration date of 10 /31/2023 2. A review of the laboratory's MOHS patient case logs revealed the laboratory performed MOHS testing on 60 patient tissues after 10/31/2023- seven cases in 2023 and fifty-three in 2024. 3. An interview with the histotechnologist on 09 /16/2024 at 9:00 a.m. confirmed that the laboratory used the observed tissue marking dyes for patient testing after expiration. D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) 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. (e) The laboratory director must-- (e)(2) and provide a safe environment in which employees are 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 -- protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on laboratory observation and staff interviews, the laboratory failed to ensure appropriate safety measures were available to protect personnel from chemical and biological hazards involved in micrographically oriented histographic surgery (MOHS) tissue processing and testing when no eyewash was present in the laboratory area. The findings include: 1. Observation of the laboratory on 09/16/2024 at 8:45 a. m. revealed that the emergency eyewash station did not contain the eye saline eyewash bottles. 2. An interview with the histotechnologist on 09/16/2024 at 8:50 a. m. confirmed the laboratory did not have eyewash available. -- 2 of 2 --

Summary Statement of Deficiencies 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 observation of the laboratory, manufacturer manual review, and staff interview, the laboratory failed to monitor temperature and humidity environmental conditions where the Avantik QS11 cryostat and Linistat automated stainer were in use for patient tissue processing in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 05/08/2023 at 9:05 a.m. revealed the Avantik QS11 cryostat (serial 59500 ) and the Thermo Scientific Linistat automated stainer (serial LS1776A1404 ) in use for processing tissue patient samples removed during Mohs surgical procedures. 2. Review of the manufacturer manuals revealed the following: Avantik QS 11 Cryostat instruction manual environmental operating conditions require 5C-35C and maximum relative humidity of 60%. Linistat automated stainer environmental operating conditions require +5C-40C and maximum relative humidity 80%. 3. Interview on 05/08/2023 at 11:00 a.m. with the laboratory director and testing person two confirmed the laboratory did not monitor room temperature or humidity conditions where the Avantik QS11 and Linistat automated stainer was in use in 2021, 2022, or 2023. 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 D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of random chart audits, Mohs Case logs, Procedure Manual, and interview with the Histotechnologist determined the laboratory failed to monitor and document the maintenance for the cryostat temperature and the automated stainer when patient samples were tested in 2017. The findings include: 1. Review of a random chart audit revealed one of four patient's surgical specimens were processed using the cryostat with no documentation of acceptable temperature and no doucmentation of the H & E stain maintenance for May 23, 2017. 2. Review of a random chart audit revealed one of four patient's surgical specimens were processed using the cryostat with no documentation of the temperature within acceptable limits for October 17, 2017. 3. Review of the Mohs Case log for May 23, 2017 revealed five patient specimens tested and reported and on October 17, 2017, four patient specimens were tested and reported. 4. Review of the Procedure Manual revealed "Equipment Quality control for Cryostats 1) Temperature is checked and recorded daily and dcumented." and "Equipment Quality Control for the Linistat Stainer 1. Stain and reagent solutions are changed daily or as needed and recorded." 5. Interview with the Histotechnologist on November 6, 2018, at 10:15 AM confirmed she had 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 -- failed to document the temperature for the cryostat used to process patient specimens on May 23 and October 17, 2017, and failed to document the H & E stain maintenance for May 23, 2017. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of a random chart audit and interview with the Histotechnologist determined the laboratory failed to document the acceptability of the H & E control slide for May 23, 2017 when patient specimens were tested and reported. The findings include: 1. Review of the random chart audit revealed one of four patients in 2017 failed to have documentation of acceptability of the H & E control slide for May 23, 2017. 2. Interview with the Histotechnologist on November 6, 2018, at 10:20 AM confirmed she failed to document the control slide for the Laboratory Director to assess on May 23, 2017, when four patients were tested and reported. -- 2 of 2 --