Francisco Flores Md Llc

Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 7th, 2024. FRANCISCO FLORES MD LLC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain documentation of the Hematoxylin and Eosin stain acceptability, stain maintenance, changing and rotation of reagents, cryostat maintenance and temperature, room temperature and humidity, and microscope maintenance for 2 out of 46 testing days during 2023 and 2024. Findings included: 1-The laboratory recorded in the "DAILY QC WORKSHEET", the stain acceptability, stain maintenance, changing and rotation of reagents, cryostat temperature and maintenance, room temperature and maintenance, and microscope maintenance. 2-Review of 'MOHS SURGERY LOG" for 2023 and 2024, revealed that the laboratory performed testing in 04/11/2023 and 04/19/2023, one patient each day. 3-Review of DAILY QC RECORDS for 2023 AND 2024 revealed that the laboratory failed to have the DAILY QC WORKSHEET on 04 /11/2023 AND 04/19/2023. During an interview on 10/07/2024 at 10:30 AM, the Histology consultant confirmed that those records were missing for the days of reference. 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 D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation and the interview with the testing person, the laboratory failed to provide adequate testing space for the histopathology testing by not having storage space for flammable chemicals, reagents and stains, and the slides and blocks storage. The findings include: On August 27, 2018 at 10AM, surveyor observed: 1- Metal cabinet with flammable, hazardous chemicals, reagents and stains in the employee breakroom. 2- Slides and blocks storage boxes for year 2014 and 2015, on top of the the employee breakroom cabinets. During an interview on 8/27/18, at 2:15 PM, the testing person confirmed that laboratory stored a- Flammable metal cabinet for hazardous chemicals and reagents in employee - break room. b- Slides and blocks storage boxes for year 2014 and 2015 on top of the employee - breakroom cabinets, as there was no adequate space in the laboratory. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview with the testing person, the laboratory director failed to: 1- Sign and date the procedure manual for histopathology laboratory. 2- Failed to include the turnaround time for test results in procedure manual, to have the 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 --