Alex City Internal Medicine

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 Beckman Coulter AcT Diff Operator's Manual, Testing Personnel (TP) #1's review of the patient test records, and an interview with TP #1, the laboratory failed to follow the manufacturer's instructions to perform quality controls after the calibrations, and before running patient samples. This was noted on two of five 2018-2020 calibrations reviewed. The findings include: 1. A review of Hematology records revealed the Beckman Coulter AcT Diff was calibrated on 09/04/2019 at 12:09 PM. However, quality control was not performed until 09/05/2019 at 8:23 AM. The instrument was also calibrated on 11/12/2020 at 11:44 PM without quality control being performed until 11/13/2020 at 8:13 AM . 2. A review of the Beckman Coulter AcT Diff Operator's Guide revealed in Chapter 5 Calibration (Page 5-18) "...17 Verify calibration by running 4C Plus cell control. See coulter 4C Plus Cell Control under Heading 2.2, Running Controls for instructions." 3. During an interview on 12/16 /2020 at 12:15 PM, Testing Personnel #1 confirmed the above noted findings, stating 6 patient CBC's (Complete Blood Counts) were performed on 09/04/2019 and 8 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 -- patient CBC's performed on 11/12/2020 after the calibrations were run and before the quality controls were performed the following day. -- 2 of 2 --

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of the installation records for the Hematology analyzer, Beckman Coulter Act diff 2, and an interview with Testing Personnel #1 (TP #1), the surveyor determined the laboratory director failed to ensure the verification procedures, performed during installation of the analyzer, were adequate to verify the manufacturer's specifications and claims of instrument performance. This failure was evident by lack of the director's signature on the installation records. This affected one of one instrument installation, which occurred during the survey review period, 3/01 /2016 - 3/27/2018. The findings include: 1. During the initial tour of the laboratory, TP #1 identified the Act Diff 2 as a new Hematology analyzer, installed in December of 2017. 2. A review of the installation records, which included accuracy, precision and reportable range studies, failed to include the laboratory director's signature as an indication of review of the verification studies and approval of use of the instrument in the laboratory. 3. In an interview on 3/27/18 at 12:54 PM, TP #1 confirmed the director had not signed the installation and verification records; though he had reviewed the documents. Patricia Watson, BS, MT (ASCP) Licensure and Certification Supervisor 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 --