Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and (re)certification is recommended. Standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's quality control records, and staff interview, the laboratory failed to follow its policy three of three times when verifying new quality control (QC) ranges from December 2024 to January 2025. Findings include: 1. A review of the laboratory's policy titled 'Quality Control Program' revealed the following: "Procedure for Verification of New Lot Number of Assayed Controls Perform this verification before the current control lot number is depleted. Before putting a new lot of control in use, verify that the new control performs as expected by parallel testing with the current lot number. - Run new control lot numbers concurrently with samples of known values, e.g. current QC - Run all levels of controls a minimum of 5 times per level." 2. A review of the laboratory's quality control records from December 2024 to January 2025 revealed the laboratory started the following quality control lot numbers and failed to have documentation of following its policy of verifying the new ranges: - Sysmex XN-L Check hematology controls Lot numbers: 43491401, 43491402, 43491403 Started on: 1/4/25 - Bio-Rad Liquid Assayed Multiqual chemistry controls Lot numbers: 46021, 46023 Started on: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 12/19/24 - Triage Total 5 Controls Lot numbers: C4079AN, C4045AN Started on: 1/1 /25 3. In an interview on 2/18/25 at 10:45 a.m. in the office, after review of the records, the laboratory director confirmed the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)