Fort Payne Care Plus Llc

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Hematology calibration records, a review of the Medonic M- series User's Manual, and an interview with Testing Personnel #2, the laboratory failed to follow the manufacturer's instructions to perform quality controls after calibration, and before running patient samples. This was noted on one of four 2019 - 2021 calibrations reviewed. The findings include: 1. A review of Hematology records revealed the Medonic was calibrated on 07/09/2020 at 2:21 PM. However, quality control was not performed following the calibration and two patient samples were tested on 07/09/2020 at 2:32 PM and 2:35 PM. 2. A review of the Medonic M-series User's Manual revealed in Section 7 Calibration(Page 62) "...18. It is recommended to run controls after calibration to verify that all parameters have been calibrated correctly. See section 1.6 to perform QC." 3. During an interview on 11/16/2021 at 2: 15 PM, Testing Personnel #2 confirmed the above findings. 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 D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the CMS form (#209), Laboratory Personnel Report for CLIA, a review of the personnel records, and an interview with the laboratory supervisor, the laboratory failed to ensure the position of Technical Consultant was filled with someone who met the required clinical qualifications. This deficient practice began on December 17, 2018, when patient testing started. The findings include: 1. On the initial of the laboratory, on September 4, 2019 at 11:30 AM, the laboratory supervisor stated CBC (Complete Blood Count) testing was included in the test menu. On the CMS Laboratory Personnel Report for CLIA, the laboratory staff listed the Laboratory Director, who is a licensed physician, as also serving as the Technical Consultant. 2. The personnel record for the physician revealed no evidence of laboratory training and experience necessary to qualify the individual as a Technical Consultant. Please refer to Interpretative Guidelines 493.1411: "The type of experience required under this regulation is clinical in nature. This means, examination and test performance on human specimens for purposes of obtaining information for the diagnosis, treatment, and monitoring of patients..." 3. In an interview on September 4, 2019 at 2:15 PM, the surveyor inquired of the physician's clinical and technical qualifications, and laboratory experience. The laboratory supervisor stated the staff thought the physician's resume would serve as evidence he has clinical laboratory experience. The surveyor discussed the CLIA regulations at 493.1411 with the laboratory supervisor, who made a copy of the interpretative guidelines pertaining to the technical consultant qualifications. 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 --