Summary:
Summary Statement of Deficiencies 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: Based on surveyor observation, review of manufacturer's instructions, laboratory policy, current PT (Prothrombin Time) thromboplastin (Dade Innovin) lot roll over, patient final reports, and confirmed in interview, the laboratory failed to follow laboratory policy for determining MNPT (Mean Normal Prothrombin Time) for two of two lots put into use in January 2022 and February 2023. Findings Included: 1. During a tour of the facility on 03/12/2024 at 09:14 a.m., the surveyor observed 1 Siemens Sysmex CA-620 coagulation analyzer in the patient testing area (Serial Number: 23771). 2. Review of thromboplastin reagent manufacturer's instructions, "Siemens Dade Innovin" (Revision 2018-08) revealed the following: "The mean normal PT (MNPT) is defined as the mean value of the normal range. It must be determined specifically for each thromboplastin lot using the method used to analyze the patient samples and, where appropriate, using the coagulation analyzer used for the analysis. Follow appropriate laboratory guidelines for establishing an MNPT." Review of manufacturer's instructions, "Siemens Healthcare Diagnostics Sysmex CA- 600 System" (Revision 08/2018; Approved by the Laboratory Director on: 10/2019) revealed the following: "XIV. Lot Roll Over Procedures Verification of Reference Range: A. 20 Normal Individuals: 10 males; 10 females representing reference population. 20 is the minimum requirement for a statistically valid study. Fresh samples preferred but frozen platelet poor plasma may be used if prepared and thawed per CLSI Guidelines. Note medication history. After review, history may be used for excluding aberrant results. B. Assay samples on current and new lot number reagents Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- simultaneously or within 1 hour of each other. C. Calculate mean and 2SD range ... ... A skewed data pool is most likely the result of improper specimen type and additional samples may be required." 3. Review of laboratory policy, "Sysmex CA 620" (Reviewed by the Laboratory Director on 02/16/2023) revealed the following: "Hemostasis Reagent New Lot Number Roll-Over Verification I. Normal Range Study a. 20 Normal Individuals b. 10 males; 10 females representing reference population. c. Fresh samples preferred, frozen samples may be used if prepared and thawed per CLSI (NCCLS) Guidelines for platelet poor. d. Medication History: no Aspirin, hormones, herbal supplements e. 20 is the minimum requirement for a statistical validity." 4. Review of laboratory thromboplastin lot roll overs, "New Coag. Lot Testing" in January 2022 (Approved by the Laboratory Director on 01/18/2022) and February 2023 (Approved by the Laboratory Director on 02/14/2023) revealed the following: a. Dade Innovin Performed: 01/18/2022 New Lot Number: 564605A Expiration Date: 09/16/2024 Review of the lot rollover documentation revealed the laboratory failed to document exclusion or partition criteria for the reference individuals used in the study (i.e., sex, geographical location, medical history, etc.). The surveyor requested the above documentation, and none was provided. b. Dade Innovin Performed: 02/14/2023 New Lot Number: 564605A Expiration Date: 09/16 /2024 Review of the lot rollover documentation revealed the laboratory failed to document exclusion or partition criteria for the reference individuals used in the study (i.e., sex, geographical location, medical history, etc.). The surveyor requested the above documentation, and none was provided. 6. Review of patient final reports revealed the laboratory performed 6,050 PT patient tests from 02/2022-12/31/2023. 7. During an interview on 03/12/2024 with GS-1 at 09:14 a.m., in the laboratory, GS-1 confirmed the laboratory failed to document exclusion and partition criteria for reference individuals used in the lot roll over studies in 2022 and 2023. This confirmed the laboratory failed to follow laboratory policy for determining MNPT for two of two lots put into use in January 2022 and February 2023. Word Key: CLSI- Clinical & Laboratory Standards Institute SD- Standard Deviation Sec- Seconds N- Number of reference individuals GS- General Supervisor Coag-Coagulation NCCLS- National Committee for Clinical Laboratory Standards 49553 Based on review of laboratory policy, laboratory records and staff interview, the laboratory failed to establish a written policy/procedure for instrument comparison for the Siemens Dimension chemistry analyzer for 4 of 4 events in 2022 and 2023. Findings include: 1. Review of laboratory records for instrument comparisons "MC3 vs MC2 Lab Comparison Testing Guide" had the following chemistry analytes in which comparisons are to be performed between analyzers in use: SN: 272024 and SN: DR272014: Na (Sodium) K (Potassium) Cl (Chloride) ECO2 (Carbon Dioxide) Glucose BUN (Blood Urea Nitrogen) Creatinine Calcium Total Protein Albumin ALP (Alkaline Phosphatase) ASP (Aspartate Transaminase) ALT (Alanine Transferase) Bilirubin, Total LDH (Lactate Dehydrogenase) Magnesium GGT (Gamma Glutamyltransferase) Phosphorous Bilirubin, Direct Instrument comparisons were reviewed by the laboratory director on the following dates: 03/28/2022 01/05/2023 (performed late in lieu of September 2022) 03/22/2023 09/20/2023 2. The laboratory was asked to provide a policy/procedure for instrument comparisons and defining acceptability criteria and none was provided. 3. The technical supervisor confirmed the laboratory failed to establish a written policy/procedure for performing calibration verification and defining acceptability criteria for the Siemens Dimension EXL chemistry analyzer conducted on 03/12/2024 at 1600 hours in the conference room. Key: SN: Serial Number D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 8 -- 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)