Levine Podiatry Group Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Levine Podiatry Group LLC on 02/15/2023. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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, and interview with the Laboratory Director, the laboratory failed to document refrigerator (where the Dermatophyte Test Medium (DTM) vials were stored) temperatures from 01/01/22 to 02/16/23 for the refrigerator in use. Findings Included: Observation during the tour of the laboratory, on 02/15/23 at 09:20 a.m., revealed the DTM vials were being stored in a refrigerator. Record review of the laboratory's policy "Quality Assurance Procedures and Regulations [undated]" revealed "6. Refrigerator temperature will monitored on a daily basis and record kept of the findings. Temperatures below 36 F [sic - Fahrenheit] and above 46 F will be reported to the physician. . ." Record review of the DTM manufacturer's instructions revealed, "STORAGE For maximum shelf life, ACU-DTM should be stored at 2 [degrees] C [Celsius] - 8 [degrees] C (36 F - 46 F). DO NOT FREEZE." On 02/15/23 at 09:40 a.m., during an interview, the Laboratory Director confirmed that refrigerator temperatures had not been documented since 12/31/21. 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 -- D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, and interview with the Laboratory Director, the laboratory failed to check the positivity and negativity reactivity for new lots of Dermatophyte test medium (DTM) for two out of two years (2021 - 2023). Findings included: Record review of the laboratory's policy "Equipment Usage and Storage" (undated) revealed "2. All DTM medium to be logged in at the time of receipt with log # [sic - number], expiration date, opened date. . . 3. Visual Inspection of medium will be done." Record review of the laboratory's policy "Quality Control Monitor" (undated) revealed "Upon opening a batch of DTM vials, a random selection of a media vial will be taken and innoculated [sic] with a positive specimen. . . Negative specimens will also be done at random. The laboratory personnel will anticipate the need for opening a new batch, and assure that the pre-test will be done prior to the need for the batch." Record review of the laboratory's "DTM Inspection and Acceptance" logs revealed the laboratory had performed quality control visual checks on lot number D087 - 0818 that was opened on lot number 09/10/20, X15 - 469 - 463 that was opened on 10/20 /20, and lot number D - 451 - 0122 that was opened on 11/1/22. No documentation was provided for checking the positivity and negativity reactivity for lot numbers, D087 - 0818, X15 - 469 - 463, and D - 451 - 0122. On 02/15/2023 at 09:50 a.m., during an interview, the Laboratory Director stated the previous Office Manager had not informed him of the previous survey deficiency of not checking the positivity and negativity reactivity of new lots of the DTM. This is a repeat deficiency. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 10/22/20 at Levine Podiatry Group, a clinical laboratory in Delray Beach, Florida. The laboratory was not in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documentation to indicate that control organisms were used to check each batch of fungal culture media for its ability to support growth and to demonstrate the correct biochemical response. The findings included: Review of fungal culture quality control records for the past two years on 10/22/20 revealed that there was no documentation to show that positive and negative controls were performed on each batch of media. Physical characteristics were documented for each batch, there were package inserts for an Accuderm quality control kit, and the laboratory had a quality control form to document the reaction of positive and negative organisms, but there were none filled out for the batches of media used over the past two years. During an interview with the laboratory assistant at 10:45 a.m. on 10/22/20 she said she must have forgotten to do the quality control. 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 --