Thakkar Patel & Avalos Md's Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Thakkar Patel & Avalos M.D.'s LLC on 4/17/24 to 4/19/24. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 records and interview the test reports for 4 of 4 (#1, #2, #3, and #4) patient reports failed to indicate the name and address of the laboratory location where the testing was performed. Findings included: 1. Record review of Patients' reports #1-dated 12/2/22, #2-dated 3/22/23, #3-dated 9/22/23, and #4-dated 1/4/24 revealed all reports were electronically signed by testing personnel but did not include the name and address for the testing location of the signing. 2. Interview on 4/17/24 at 1:15 PM with the Laboratory QA (Quality Assurance) Coordinator/Compliance Officer for laboratory B, confirmed the professional component of the patient Histology testing was performed at laboratory B, which was not listed on the patients' reports. 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 D0000 An announced CLIA recertification survey was conducted at Thakkar, Patel, & Avalos MDS LLC on 02/11/22 - 02/15/22. 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 record review and interview with Testing Personnel and the new Practice Manager, the laboratory failed to follow the laboratory's policy for the temperature of the water bath for 403 days out of 403 days of testing from November 14, 2019 to February 11, 2022. Findings Included: Review of the "TPA Histology Lab" log revealed an unidentified range of 36-42. Review of policy and procedure titled "Microntomy" signed by the Laboratory Director on 02/08/22 revealed "a. Fill tissue bath with distilled water, heat to 40-45 degrees C [Celsius]." On February 11, 2022 at 11:30 am, Testing Personnel #B stated the range of 36 - 42 was the temperature range for the water bath and confirmed the temperature range did not match the laboratory's policy and procedure. Review of the "TPA Histology Lab" logs revealed the temperature of the water bath had been below the 40 - 45 degrees Celsius range found in the laboratory's policy for 403 days out of 403 days of testing from November 14, 2019 to February 11, 2022 (date of survey). On February 11, 2022 at 11:50 am, 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 3 -- new Practice Manager confirmed the water bath temperature range was incorrect and that the temperatures were recorded out of the acceptable range with no