Flores Dermatology Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at FLORES DERMATOLOGY on July 17, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to have documentation of the acceptability of the Quality Control (QC) slide for Hematoxylin & Eosin (H&E) stain for one out of five testing dates in March 2025. Findings included: 1-The laboratory used the "MOHS DAILY QC WORKSHEET" to record the acceptability of the daily H&E stain. Review of the QC log for March 2025 revealed that on March 10, 2025, there was no record of QC approval. 2-Review of patient Log for the day of reference revealed that 8 patients were tested on that day. 3- During an interview on 07/17/2025 at 12:00 PM the Office Consultant confirmed that the Mohs surgeon failed to document the acceptability of the Daily QC slide for H& E Stain for March 10, 2025. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory Quality Assessment (QA) failed to identify and correct the deficiency of missing record in Hematoxylin and Eosin (H&E) stain maintenance log in one out of four testing dates in August 2023. Based on record review and staff interview, the laboratory Quality Assessment (QA) failed to identify and correct the deficiency of missing record in the Mohs Daily Quality Control (QC) log and Hematoxylin and Eosin (H&E) stain maintenance log in one out of five testing dates in March 2025. Findings included: 1-Review of the "QUALITY ASSURANCE PROGRAM" Policy in the Procedure Manual signed by the Laboratory Director on 01/06/2025, revealed that in section "VI Specimen Collection and Slide preparation" listed the parameters to consider in the slide preparation, temperature for Cryostat, staining solutions for Frozen sections must be filtered or changed at least weekly depending in usage, instrument maintenance. 2- The Laboratory implemented a Quarterly Checklist to monitor the QA activity. This QA checklist included different sections in "Analytical "listed the following parameters: "1. Overall assessment of laboratory testing. 2. Overall assessment of diagnostic procedure. 3. Overall assessment of processing. 4. Overall adequacy of stain line. 5. Monitoring Chemicals quality." 3-The laboratory used "MOHS DAILY QC WORKSHEET" log (Log #1) to record Daily H&E QC stain, Microscope verification, Cryostat Maintenance, Room Temperature and Humidity and log "HEMATOXYLIN AND EOSIN STAINING MAINTENANCE LOG MOHS" (Log #2) to document the actions performed by the technical to the maintenance of the reagents used for the H&E stain. 4-Review of the Log 1 for August 2023 revealed that the laboratory performed five testing days (08/07/2023, 08/17/2023, 08/21/2023 and 08/28/2023). Review of Log #2 revealed that the laboratory missed recording the H&E stain maintenance for 08/28/2023. Review of the Quarterly QA checklist for August 2023 revealed no reference to the missing record in point "4. Overall adequacy of stain line" and the Laboratory Director graded with an "Outstanding" qualification. The laboratory tested six patients on 08/28/2025. 5-Review of Patient log, Log1 and Log 2 for March 2025, revealed that the laboratory performed five testing days: 03/03/2025, 03/10/2025, 03/17/2025, 03/24/2025 and 03/31/2025. Reviews of Log #1 and Log #2 revealed that the laboratory failed to record all the data for 03/10/2025, the laboratory tested 8 patients that day. The Quarterly QA checklist report for April 2025 was signed by the Laboratory Director but failed to have an evaluation of the activity and did not mention any

Summary Statement of Deficiencies D0000 A recertification survey conducted on 10/16/2019 found that Javier Flores MD PA clinical laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and staff interview, the laboratory failed to document the room humidity for 9 out of 35 testing days in 2019. Findings include: Review of the cryostat manual Leica CM1510S indicated a requirement for room humidity at or below 60 %. Quality control records review revealed that there was no documentation of the room humidity for the following testing dates: 4/29/2019, 5/6/2019, 5/20/2019, 6/3/2019, 6/10/2019, 6/17/2019, 6/24/2019, 7/1/2019, 7/8/2019. During an interview on 10/16/19 at 12:00 p.m., the testing personnel # A confirmed that there was no record of room humidity for the days of reference. 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 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 -- 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 patient reports review and interview with testing personnel (TP) #A, the laboratory failed to include the correct address in the final reports for 3 out of 3 patients reports reviewed. Findings include: Review of the following 3 patient reports: FD18-0461 (2018), FD19-488, FD19-483 (2019), revealed that the reports had incorrect laboratory name listed. During an interview on 10/16/19 at 11:00 a.m., the TP#A confirmed that the final report did not include the correct laboratory name. -- 2 of 2 --