Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the General Supervisor (GS), the laboratory failed to maintain the patient raw data print-outs from the Cobas integra 400 used for chemistry testing. The findings include 1. The raw data print-outs containing results and data alarm flags were not maintained. 2. The GS confirmed on 9/13/23 at 11:00 am that raw data print-outs containing results and data alarm flags were not maintained D5401 PROCEDURE MANUAL CFR(s): 493.1251(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: A) Based on surveyor review of the Procedure Manual (PM) and interview with the General Supervisor (GS), the laboratory failed to have a complete Quality Assessment procedure from 10/12/22 to the date of survey. The findings include: 1. The PM under QA procedures did not provide the calculation that verified estimated Glomerular Filtration Rate (eGFR) as accurate. 2. The GS confirmed on 9/12/23 at 12:30 pm that Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- the laboratory failed to have the aforementioned procedure. B) Based on surveyor review of the PM, Quality Control Assay Sheet (QCAS), Cobas Integra 400 analyzer and interview with the GS, the laboratory failed to follow their policy for "Establishing a Working Mean an 2SD Range:" from 10/12/22 to the date of survey. The findings include: 1. The PM stated under "Establishing a Working Mean an 2SD Range:" "2. Collect a minimum of twenty data points for each level of control material.". "6. Calculate acceptable limits for the control" 2. Bio-Rad Liquid Assayed Multiqual Lot #45930 QCAS stated as follows. a) Level 1 Chloride 74.60-83.20 mmol /L b) Level 1 Carbon Dioxide 11.80-20.20 mmol/L c) Level 1 Lipase 16.60-28-60 16.60-124.0 U/L 3. Control values in the Cobas Itergra 400 analyzer was as follows. a) Level 1 Chloride 74.60-83.20 mmol/L b) Level 1 Carbon Dioxide 11.80-20.20 mmol/L c) Level 1 Lipase 16.60-28-60 16.60-124.0 U/L 4. The laboratory did not use the control values calculated as per the PM 5. The GS confirmed on 9/13/23 at 12:30 pm that the laboratory failed to follow the aforementioned procedures. 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)