Mark S Block Dpm

Summary Statement of Deficiencies D0000 A recertification survey conducted on 01/20/2023 found the MARK S BLOCK DPM clinical laboratory 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 observation, record review and interview, the laboratory failed to follow manufacturer instructions for temperature storage of Dermatophyte Test Medium (DTM) Agar tube from 01/01/2021 to present. Findings include: During the laboratory tour on 01/20/2023 at 10:00 AM, the surveyor found two boxes of Remel DTM Agar with lot number 579797 and three boxes of lot number 583651 stored at room temperature in the facility storage room. -Observation of Remel DTM Agar box label revealed that displayed the sign for storage at "2 - 8 C". -Review of patient log from 01 /01/2021 to 01/20/2023 revealed that during 2021 the laboratory tested 165 patients, during 2022 tested 127 patients and in January 2023 tested six patients. During an interview on 01/20/2023 at 10:00 AM, the testing person confirmed that the laboratory failed to store the DTM Agar as per manufacturer instructions for the period 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with testing personnel (TP) B, the laboratory failed to document the annual competency assessment on 1 out of 2 testing personnel for 2017 and 2018 period. Findings include: Review of employee documentation showed that the laboratory failed to have documentation of annual competency assessment on 2017 and 2018 for TP B. During an interview on 01/08/2019 at 12:30 PM, with TP B, she confirmed that there was no competency assessment documented for the period 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 --