Medical Center Hospital Laboratory

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a validation survey conducted June 24 through June 26, 2025. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on review of laboratory policy, laboratory transfusion reaction workups, and confirmed in interview, the laboratory failed to ensure a culture work up for blood units transfused for six of six patients who met the work up criteria for records reviewed from February 2023 through May 2025. The findings included: 1. Review of the laboratory blood bank policy titled "Transfusion Reaction Investigation" included the following instructions: "II. Immediate blood bank workup on all investigations: ... B. Evaluate signs and symptoms: a. If the ONLY signs and symptoms noted include urticaria, hives, itching and/or local erythema (allergic reaction at infusion site) then no serologic testing is required. Stop the investigation here, call pathologist with findings, and report the transfusion reaction as "No evidence of hemolytic transfusion reaction". b. Presence of ANY other sign or symptom with or without the symptoms listed in "1" [sic] above will require serologic evaluation of the reaction. Call the findings to pathologist and continue with "C" below. III. Extended blood bank workup (when indicated): A. Evaluate type of component transfused: a. Red Blood Cells: An adverse reaction to a transfusion containing red cells is regarded as serious and steps will be taken to verify that a hemolytic reaction has not occurred. Continue with "F" below. ... F. Document all findings on transfusion reaction investigation worksheet. ... Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- J. If the patient experienced a rise in temperature (greater that or equal to) 2 (degrees) F (1 (degrees) C) then order and set up culture (see Processing Culture on Blood Components policy)." Review of the laboratory blood bank policy titled "Processing Cultures on Blood Components" included the following statement: "Bacterial contamination remains a significant cause of transfusion morbidity and mortality. The blood/component unit will be cultured when the patient's transfusion reaction investigation shows a (greater than or equal to) 1 (degree) C increase in temperature or upon pathologist's request. " 2. Review of laboratory transfusion reaction workups included six patients with a temperature increase greater than or equal to 2 (degrees) F during transfusion initiating a transfusion reaction workup: 01/24/2025: MRN 000457549 Component Transfused: RBC Symptom Reported: Fever Temperature pre- transfusion: 98.1 (degrees)F Temperature post-transfusion: 100.6 (degrees)F Temperature increase: 2.5(degrees) F 02/08/2023: MRN 645877626 Component Transfused: RBC Symptom Reported: Chills, Fever Temperature pre-transfusion 99.3 (degrees)F Temperature post-transfusion: 102.0(degrees)F Temperature increase: 2.7 (degrees) F 05/18/2023: MRN 645835169 Component Transfused: RBC Symptom Reported: Fever, Dyspnea Temperature pre-transfusion: 100.5 (degrees)F Temperature post-transfusion: 102.9 (degrees)F Temperature increase: 2.4 (degrees) F 08/15/2023: MRN000494086 Component Transfused: RBC Symptom Reported: Chills, Fever Temperature pre-transfusion: 98.3 (degrees)F Temperature post- transfusion: 100.5 (degrees) Temperature increase: 2.2 (degrees) F 05/07/2025: MRN 646329001 Component Transfused: RBC Symptom Reported: Fever Temperature pre- transfusion: 98.2 (degrees)F Temperature post-transfusion: 101.2 (degrees) F Temperature increase: 3.0 (degrees) F 05/21/2025: MRN 646277851 Component Transfused: RBC Symptom Reported: Fever Temperature pre-transfusion: 97.8 (degrees)F Temperature post-transfusion: 99.8 (degrees) F Temperature increase: 2.0 (degrees) F Surveyor asked for documentation that the laboratory proceeded with a culture workup on the transfused blood component, to rule in or out bacterial contamination, and none could be provided. 3. In an interview on 6/25/2025 at 11:38 hours, in the office, the blood bank technical supervisor confirmed that a culture workup on the transfused RBC units for the patients whose transfusion reaction investigation showed a greater than or equal to 2 (degree) F increase in temperature. KEY F: Fahrenheit C: Celsius D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: A. Based on a review of the laboratory's policy, surveyor observation, review of the manufacturer's instructions, patient test records, and staff interview, the laboratory failed to ensure the temperature for two of two patient's blood specimens used for Prothrombin time (PT) testing were maintained during transport on June 26, 2025. Findings include: 1. A review of the laboratory's policy titled 'Specimen Transport' revealed the following: "MCH Laboratory's goal is to ensure that all medical specimens arrive at the testing facility: - At the correct temperature for testing - Intact -- 2 of 14 -- in the container, without breakage or leakage - In the shortest possible time - In compliance with all applicable regulations" 2. Surveyor observation of the laboratory on 6/26/25 at 10:40 a.m. revealed a hospital courier arrived carrying a soft sided cooler with ice packs in the bottom. Four small biohazard bags were removed from the cooler, all containing patient's blood specimens. Two blue top (sodium citrate) tubes were at the bottom of one of the biohazard bags. When the surveyor grabbed the tubes to retrieve the patient's names, both tubes were cold to the touch. 3. An interview with the hospital courier on 6/26/25 at 10:43 a.m. revealed there were no temperature monitors in use to ensure proper temperatures for the specimens were being maintained. 4. A review of the STA- Neoplastine CI Plus Instructions for Use (REF 00606, December 2017) revealed the following: "Specimen Collection and Treatment Blood is collected in 0.109 M (3.2%) trisodium citrate anticoagulant. Centrifugation: 15 minutes at 2000 - 2500 g. Plasma storage: 8 hours at 20 +/- 5 degrees Celsius. Do not store plasma at 2 -8 degrees Celsius." 5. A review of patient test records revealed the following 2 specimens from the above listed shipment were tested for Prothrombin time and resulted on 6/26/25 and the laboratory failed to ensure the temperature of the specimens were maintained during transport: Patient ID: 000516898 Patient ID: 000035531 6. In an interview on 6/26/25 at 12:05 p.m. in the office, after review of the records, technical consultant #2 (as indicated on the CMS 209 form) confirmed the above findings. 49553 B. Based on review of the laboratory's policy, review of the manufacturer's package insert, review, review of the laboratory's instrument records, and confirmed in interview, the laboratory failed to ensure specimen stability for five of six lactic acid tests in 2025 (random review). Findings include: 1. Review of the laboratory's policy titled "Collection, Preservation, and Storage of Chemistry Samples" stated: "PROCEDURE: ...B. Lactic Acid (Lactate) a. To assure the integrity of lactic acid testing, collection must occur in a gray top tube and transported on ice to the lab, where it must be centrifuged within 15 minutes of collection." 2. Review of the manufacturer's package insert titled "cobas LACT2", version 2024-08, V4.0 English stated: "Specimen collection and preparation ... Centrifuge within 15 minutes of collecting the specimen." 3. Review of the laboratory's records determined the laboratory failed to ensure specimen stability for five of six lactic acid tests in 2025 (random review): a. Accession #: 25-175-0456 Collect date/time: 06/24/2025 09:00 AM Centrifuge date/time: 06/24/2025 09:18 AM Time elapsed: 18 minutes Result: 10.8 mmol/L b. Accession #: 25-175-0373 Collect date/time: 06/24/2025 03:10 AM Centrifuge date/time: 06/24/2025 03:58 AM Time elapsed: 48 minutes Result: 10.0 mmol/L c. Accession #: 25-175-0219 Collect date /time: 06/24/2025 02:31 AM Centrifuge date/time: 06/24/2025 03:21 AM Time elapsed: 50 minutes Result: 11.9 mmol/L d. Accession #: 25-175-1872 Collect date /time: 06/24/2025 07:40 PM Centrifuge date/time: 06/24/2025 08:20 PM Time elapsed: 40 minutes Result: 4.1 mmol/L e. Accession #: 25-175-0255 Collect date /time: 06/24/2025 12:29 AM Centrifuge date/time: 06/24/2025 12:54 AM Time elapsed: 25 minutes Result: 11.3 mmol/L 4. Technical consultant-2 (as listed on the CMS-209 form) confirmed the findings in an interview conducted on 06/25/2025 at 1612 hours in the office. Key: mmol/L - millimoles per liter CMS - Centers for Medicare and Medicaid Services D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) (d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. -- 3 of 14 -- This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions for use, surveyor observation, the laboratory's records, and staff interview, the laboratory failed to ensure the instructions for outside clients included specimen storage and preservation procedures for prothrombin time (PT) testing for five of five patient specimens received in pour over tubes and tested in June 2025. Findings include: 1. A review of the STA- Neoplastine CI Plus Instructions for Use (REF 00606, December 2017) revealed the following: "Specimen Collection and Treatment Blood is collected in 0.109 M (3.2%) trisodium citrate anticoagulant. Centrifugation: 15 minutes at 2000 - 2500 g. Plasma storage: 8 hours at 20 +/- 5 degrees Celsius. Do not store plasma at 2 -8 degrees Celsius." 2. Surveyor observation of the laboratory on 6/25/25 at 4:00 p.m. revealed 5 patient's plasma specimens in pour over tubes in the Coagulation specimen storage racks. 3. A review of the laboratory's records revealed no documentation that the samples were properly centrifuged per the manufacturer's requirements and platelet poor plasma was produced. 4. Further review of the laboratory's records revealed the patient's specimens were run for PT testing and the results were reported: Patient ID: 000240272 Resulted: 6/23/25 Patient ID: 646332865 Resulted: 6/23/25 Patient ID: 645879886 Resulted: 6/24/25 Patient ID: 646334844 Resulted: 6/24/25 Patient ID: 645821218 Resulted: 6/24/25 5. In an interview on 6/25/25 at 4:07 p.m. in the office, after review of the records, technical consultant #2 (as indicated on the CMS 209 form) confirmed that the laboratory failed to provided instructions to outside clients that included the proper specimen storage and preservation as described by the manufacturer. 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 review of laboratory policy, laboratory quality control records, and confirmed in interview, the laboratory failed to ensure the documentation and expiration of external quality control (QC) used in for the detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) testing on the Cephied GeneXpert RT-PCR system for records 16 of 16 QC records reviewed from January through March 2024 and October through January 2024. The findings included: 1. Review of the laboratory microbiology policy titled "Cepheid Xpert CT/NG Assay Procedure", section "Quality Control" included the following instructions: "Quality Control: A. Test appropriate manufacture recommended QC strains on each new lot /shipment of cartridges before or concurrently with placing materials into use for testing patient specimens using the Xpert CTNG Assay. B. Follow the Microbiologic External control procedure described below: ... f. See the following example for logging in the control into the computer: Sample ID: CTNG POSITIVE CONTROL or CTNG NEGATIVE CONTROL Notes: LOT # (Control Lot #), EXP. (Control Expiration Date)." 2. Review of the Cepheid Xpert CT/NG instrument print outs for 2024 quality control did not include the QC lot number and expiration date for the positive and negative QC reviewed from January 2024 through March 2024 and October 2024 through December 2024: January 2024: QC performed two times. 01/04 -- 4 of 14 -- /2024 01/12/2024 February 2024: QC performed three times. 02/07/2024 02/12/2024 02/20/2024 March 2024: QC performed three times. 03/05/2024 03/24/2024 03/25 /2024 October 2024: QC performed three times. 10/03/2024 10/18/2024 10/18/2024 November 2024: QC performed two times. 11/18/2024 11/25/2024 December 2024: QC Performed three times. 12/10/2024 12/17/2024 12/30/2024 Surveyor asked if the QC lot numbers, and expiration dates, were documented elsewhere and none could be provided. 3. In an interview on 6/26/2024 at 11:30 hours, in microbiology, the microbiology technical supervisor and microbiology lead tech confirmed the lot number and expiration date for the QC had not been documented for the records reviewed. 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)