Kevin A Fuciarelli Md Pc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of accuracy verification documentation for Frozen Biopsy testing and interview with the laboratory director (LD), the laboratory failed to verify the accuracy of testing performed under the subspecialty of Histopathology at least twice annually during 2022 and 2023. Findings include: 1. No documentation was presented for review to indicate the laboratory verified the accuracy of Frozen Biopsy testing at least twice annually during 2022 and 2023. 2. The LD interviewed on 4/12/2024 at 10: 15 AM confirmed the laboratory failed to verify the accuracy of Frozen Biopsy testing at least twice annually during 2022 and 2023. 3. The laboratory's reported annual test volume is 1500 in the subspecialty of Histopathology. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of established quality assessment (QA) policies and procedures and interview with the laboratory director (LD), the laboratory failed to establish policies and procedures to monitor, assess and correct problems identified in the general 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 -- laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. No QA documentation was provided for review during the survey conducted on 4/12/2024 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the general laboratory system requirements specified at 493.1231 through 493.1236, including but not limited to, Proficiency Testing and/or accuracy verification policies and procedures. 2. The LD interviewed on 4/12/2024 at 10:35 AM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the general laboratory systems requirements. 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 lack of humidity records for review from 2022, 2023 and 2024, review of the manufacturer's specifications for the Leica CM1510 Cryostat, and interview with the laboratory director (LD), the laboratory failed to monitor and document the humidity of the room where the above instrumentation is utilized. Findings include: 1. The laboratory utilizes the Leica CM1510 Cryostat in conjunction with Mohs testing under the subspecialty of Histopathology with a reported annual test volume of 1500. 2. The manufacturer's specifications for the Leica CM1510 Cryostat reviewed during the survey listed an operating relative humidity range of 10%-60%. 3. On the survey date of 4/12/2024, no documentation was provided for review to indicate the laboratory monitored and documented the humidity of the room where the above instrumentation is utilized on each day of patient testing during 2022, 2023 and 2024 through the date of the survey. 4. The LD interviewed on 4/12/2024 at 10:25 AM confirmed the laboratory failed to monitor and document the ambient humidity as indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on lack of quality assessment (QA) policies and procedures and interview with the laboratory director (LD), the laboratory failed to establish QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. Findings include: 1. No QA -- 2 of 3 -- documentation was provided for review during the survey conducted on 4/12/2024 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the analytic systems specified at 493. 1231 through 493.1236. 2. The LD interviewed on 4/12/2024 at 10:35 AM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the analytic systems. **This is a repeat deficiency from the previous survey conducted on 10/21/2021.** -- 3 of 3 --

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 lack of temperature records for review and interview with the facility personnel, the laboratory failed to monitor and document the room temperature where dermatopathology reagents are utilized and stored and failed to monitor and document the temperature of the cryostat used in conjunction with Mohs testing during February 2021. Findings include: 1. The laboratory processes and interprets dermatopathology slides in conjunction with Mohs surgery, with an approximate annual test volume of 2,356. 2. No room temperature documentation was presented for review from February 2021 to indicate the laboratory monitored and documented the temperature of the room each day of patient testing, where dermatopathology reagents are utilized and stored. 3. No documentation was presented for review to indicate the laboratory monitored and documented the cryostat temperature each day of patient testing during February 2021. 4. The laboratory performed testing on approximately 67 patients during February 2021. 5. The facility personnel confirmed that the laboratory failed to monitor and document the cryostat temperature and the room temperature of the laboratory where reagents are stored and used for patient testing during February 2021. D5433 MAINTENANCE AND FUNCTION CHECKS 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 -- 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 microscope maintenance logs and interview with the facility personnel, the laboratory failed to perform and document the microscope maintenance as defined by policy during February 2021. Findings include: 1. The laboratory log titled, "Lab Maintenance" indicates the Microscope is cleaned once a month and evidence of the cleaning is documented on each monthly log. 2. No documentation was presented for review to indicate the laboratory performed the microscope maintenance as indicated above during February 2021. Approximately 67 patients were tested during that time period. 3. The facility personnel confirmed that the laboratory failed to perform and document maintenance on the microscope as indicated in policy during the timeframe indicated above. 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 lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to document the acceptability of staining materials used for patient testing performed in the sub-specialty of histopathology. Findings include: 1. The laboratory performs testing in the sub-specialty of Histopathology, with an approximate annual test volume of 2,356. 2. No documentation of the Hematoxylin & Eosin (H & E) stain acceptability was presented for review for testing that occurred during February 2021. Approximately 67 patients were tested during that time period. 3. The facility personnel confirmed that the laboratory failed to document the stain acceptability during February 2021, as indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's established quality assessment (QA) policies and procedures and interview with the facility personnel, the laboratory failed to establish a mechanism in their QA processes to monitor the analytic portion of histopathology testing that is performed by the laboratory. Findings include: 1. The laboratory processes and interprets histopathology slides from patient specimens during the Mohs process. The laboratory's approximate annual test volume is 2,356. 2. No documentation was submitted for review during the survey to indicate the laboratory established QA policies and procedures to monitor, assess, and when inicated, correct problems identified in the analytic systems. See D5413, D5433 and D5473 for specific findings. 3. The facility personnel confirmed that the laboratory's established QA process did not monitor the analytic systems for errors or missing records. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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: Based on lack of Quality Control records for review, the laboratory director failed to ensure that quality control programs are maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5473 for findings. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the laboratory's test reports and interview with the facility personnel, the Mohs test reports failed to include the name and address of the laboratory where the reading of the dermatopathology slides was performed . Findings include: 1. The laboratory performs the Mohs procedure on patient specimens, with an approximate annual test volume of 1,632. 2. Four out of four Mohs test reports reviewed during the survey (#17-244, 17-694, 18-517 and 18-856) were missing the name and address of the laboratory where the reading of the dermatopathology slides was performed. 3. The facility personnel confirmed that the laboratory name and address were missing from the Mohs test reports indicated above. 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 --