Christus Good Shepherd Medical Center-Kilgore

Summary Statement of Deficiencies D0000 In a validation survey conducted from 7/11/2023 to 7/13/2023, the laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; D6168 - 42 C.F.R. 493.1487 Condition: Laboratories performing high complexity testing; testing personnel; D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the Casper Report 155 Individual Laboratory Profile, proficiency testing records for 2021, 2022 and 2023,policies and procedures and interview of facility personnel, the laboratory failed to participate in one of five proficiency testing events for the specialty of Hematology. The findings include: 1. Review of the Casper Report 155 Individual Laboratory Profile found the laboratory received a score of 0% in the first event of 2023 for Hematology. 2 A review of the American Proficiency Institute (API) proficiency testing records found the laboratory failed to submit the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- results in the time frame specified by the program for the 2023 1st testing event. a. Review of the 2023 API PT Schedule found the PT Results due Date defined as March 29, 2023. b. Review of the 2023 Hematology/Coagulation - 1st Event Attestation Statement found that testing personnel had tested assigned proficiency specimens between 03/07/2023 and 03/21/2023. c. Review of the 2023 Hematology 2nd event Performance Summary found scores of 0% for all analytes due to a failure to participate as defined in the column labeled Notes. 3. Review of the policy QIP2021 Proficiency Testing Procedure found under the heading PROCEDURE: "4.c. Data will be submitted on or before the due date." 4. During interview of testing person one on the CMS Report 209 Laboratory Personnel Report conducted July 11, 2023 at 11:53 AM , she confirmed that the results were not submitted to the PT agency for grading prior to the final submission date of March 29, 2023. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of laboratory policy, reagent instructions for use, laboratory documents, and confirmed in interview, the laboratory failed to analyze 6 of 19 patients with ammonia testing within 30 minutes of collection on the DxC600 chemistry analyzer in 2022. The findings included: 1. Review of the laboratory policy titled "QIP100 Laboratory Quality Improvement Plan", section "VIII Monitoring Criteria" stated the following: "As a part of the Laboratory Quality Improvement Plan, the laboratory will monitor the following functions for quality:" Bullet 11 "Timely reporting of all test results including "STAT" turnaround time." 2. Review of the reagent instructions for use for Ammonia testing stated the following: "Specimen Storage and Stability: Tubes should be filled completely, mixed gently by inversion, placed on ice, centrifuged immediately for 10 minutes at an RCF of 1500G and analyzed within 30 minutes ..." Surveyor queried on 7/12/2023 at 16:25 hours, for the QA in regards to turn around time (TAT) monitoring for ammonia for 2022 and none was provided. 3. Review of laboratory-provided documents for ammonia testing in 2022 included the following six patients with a TAT from drawn to complete greater than 30 minutes: Patient: Date/Time Drawn - Date/Time Completed - Time to Completion 22-072-006155 - 3/13/2022, 23:04 - 3/13/2022, 23:36 - 00:32 minutes 22- 094-003870 - 4/4/2022, 09:10 - 4/4/2022, 09:56 - 00:45 minutes 22-096-008395 - 4/6 /2022, 13:44 - 4/6/2022, 14:55 - 1 hour 11 minutes 22-208-007965 - 7/27/2022, 12:33 - 7/27/2022, 13:39 - 1 hour 06 minutes 22-223-002648 - 8/11/2022, 07:54 - 8/11 /2022, 08:41 - 00:47 minutes 22-339-005623 - 12/5/2022, 09:54 - 12/5/2022, 11:08 - 1 hour 14 minutes 4. In an interview on 7/13/2023 at 10:37 hours, in the laboratory, the Compliance Coordinator and the Laboratory Administrative Director confirmed that the laboratory failed to ensure that ammonia testing was performed within 30 minutes of collection for patients tested in 2022. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) -- 2 of 15 -- 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 laboratory policy, laboratory quality control (QC) instructions for use (IFU), laboratory QC documentation, and confirmed in interviews the laboratory failed to follow its policy for the establishment of means and standard deviation (SD) ranges for three of three analytes in use on the Access 2 chemistry analyzer in 2022. The findings included: 1. Review of the laboratory policy titled "CH 110 Controls", section "Quantitative Controls" had the following instructions: "B. Use of ASSAYED CONTROLS The laboratory mean is established for each new lot of controls. When appropriate the laboratory will establish its own standard deviation (SD). Prior to placing a new lot number of control into use a minimum of 60 samples are tested concurrently with the old lot number. The new control mean and SD (where applicable) is updated and entered in the LIS computer under the new lot number. The only exception is 6C controls which is managed in the DXH software. If controls cannot be tested concurrently, peer mean and SD values are used as target values until a minimum of 60 samples are tested and the laboratory mean and SD (where applicable) are calculated. Package insert ranges can be used as target values if peer data is not available. In conjunction with monthly QC review, laboratory mean and SD are adjusted if needed. Manual cell count manufacturer's control ranges are verified prior to putting a new lot in use. Once verified, the manufacturer's range is acceptable to use by the laboratory." The surveyor queried TC2, on 7/12/2023 at 10: 15 hours, as to which of the above methods they used for the laboratory's assayed controls on the Access 2 chemistry analyzer. It was stated that they establish their own means and use the QC IFU standard deviation (SD) to calculate the acceptable ranges. 2. Review of the assayed QC for Troponin (TNI), B-Type Natriuretic Peptide (BNP), and Human chorionic gonadotropin (hCG), had the following discrepancies between the IFU's SD and SD's used for the acceptability of QC: Cardiac Control 1, Lot 67661, put in use 9/2021 Analyte: TNI Mean: 0.039 IFU Range: 0.023 - 0.055 In Use Range: 0.029 - 0.049 Analyte: BNP Mean: 74.3 IFU Range: 64.6 - 84.0 In Use Range: 64.3 - 84.3 Cardiac Control 2, Lot 67662, put in use 9/2021 Analyte: TNI Mean: 0.793 IFU Range: 0.643 - 0.943 In Use Range: 0.693 - 0.893 Analyte: BNP Mean: 370.0 IFU Range: 328 - 412 In Use Range: 340.0 - 400.0 QC Cardiac 3, Lot 67663, put in use 9 /2021 Analyte: BNP Mean: 1325.0 IFU Range: 1192.34 - 1457.66 In Use Range: 1261.0 - 1389.0 Liquichek Immunoassay Plus Control 1, Lot 85321, put in use 10 /2022 Analyte: hCG Quantitative Mean: 6.00 IFU Range: 5.04 - 6.96 In Use Range: 5.00 - 7.00 Liquichek Immunoassay Plus Control 2, Lot 85322, put in use 10/2022 Analyte: hCG Quantitative Mean: 20.0 IFU Range: 17.74 - 22.26 In Use Range: 18 - 22.0 Liquichek Immunoassay Plus Control 3, lot 85323, put in use 10/2022 Analyte: hCG Quantitative Mean: 400.00 IFU Range: 358.66 - 441.34 In Use Range: 370.00 - 430.00 Surveyor queried about the discrepancies on 7/12/2023 at 12:00 hours, in the laboratory, and TC2 stated that the laboratory will occasionally use the peer SD. Surveyor queried if they recalculated the SD after 60 samples were tested, as described in the policy, and TC stated they were not. 3. In an interview on 7/12/2023 at 13:39, in the laboratory, TC2 confirmed that the laboratory failed to follow its own policy for the establishment of control SDs for new lot QC being put into use on the Beckman Coulter Access 2. -- 3 of 15 -- 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)