Summary:
Summary Statement of Deficiencies D0000 Based on an announced validation inspection, the laboratory was found NOT to be in compliance with the CLIA regulations found at 42 CFR 493 CLIA requirements. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; 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. 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 nursing and laboratory's policies and procedures, transfusion records, and interview, the facility failed to follow its policy and procedure for recording vital signs used to identify blood and blood product transfusion reactions for one out of four units reviewed. Findings follow. A. Review of the nursing policy and procedure titled "PC.3500 Administration of Blood and Blood Products," revised 06 /01/2021, under Procedure stated, "...11. Take baseline vitals before starting transfusion and record in Transfusion Record. After blood has started infusing, stay with the patient for at least 15 minutes to check for a transfusion reaction. Repeat vital signs at 15 minutes and at one hour after the start of transfusion, and then at the end of the transfusion. Document all vitals in the Transfusion Record...." The policy does not define what constitutes a vital sign. B. Review of the Emergency Blood Release Forms showed 4 units were transfused from March 2023 - June 2024. C. One transfusion was missing vital signs: 1. Medical Record Number (MR#) 5266288 Unit # W140923041288 packed red blood cells Started 12/09/2023 at 0431 Transferred 12 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 -- /09/2023 at 0459 Vitals taken at: 0429 (prior), 0506 (35 minute) Per policy, missing 15-minute vital signs D. Interview with Technical Supervisor #1 (as listed on the CMS form 209) on September 4, 2024 at 1650 hours confirmed the findings. 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: I. Based on review of manufacturer's instructions, quality control (QC) records, and interview, the laboratory failed to retain the Complete Blood Count (CBC) monthly QC reports from the Sysmex XS-1000i for two of two years reviewed. Findings follow. A. Review of the Sysmex XS-1000i Instructions for Use manual, 06/2013, under Chapter 6 Operation at 6.8 QC stated, "Quality control assures the reliability of the instrument and reagents system. Quality control allows log-term monitoring of the stability of analysis value. It can also identify problems at an earlier stage and prevent them... Quality control is analyzed using x-bar Control or the L-J Control program. The data is saved in the quality control file...." At Chapter 7 Quality Control under 15. QC Chart Screen stated, "The QC Chart screen shows the chart for the QC file selected on the QC File screen. One QC file can record and display up to 300 plots. If more are displayed, the excess points are automatically deleted, starting with the oldest.... Sysmex Insight Important! The Sysmex Insight screen is only intended for downloading QC data that will be sent to the Interlaboratory Quality Assurance Program. This program should not be used by the laboratory as a method to backup QC for their own records...." B. Review of the Sysmex XS-1000i quality control records showed the QC from the analyzer was not printed and retained. The laboratory retained the Insight reports, Insight reports did not show what analyte was out of range and the value, along with the QC ranges used to evaluate the QC runs. C. Surveyor requested QC records from the analyzer for March 2024 - June 2024 on September 3, 2024 at 1630 hours. No documentation was provided. D. Interview with Technical Consultant #1 (as listed on the CMS form 209), on September 3, 2024 at 1605 hours confirmed the findings, and confirmed they didn't retain the QC reports for the last two years. Continued interview at 1645 hours confirmed she was unable to access the QC files from March 2024 - June 2024 because the new QC files replaced the old files. II. Based on review of the laboratory's QC records, and interview, the laboratory failed to retain the control package inserts for the Radiometer Qualicheck 5+ lots in use for two of two years reviewed. Findings follow. A. The Radiometer Qualicheck 5+ control package inserts were requested on September 4, 2024 at 1520 hours but not provided. B. Interview with Technical Consultant #1 on September 4, 2024 at 1520 hours stated they did not keep prior package inserts, just for the current lot in use, for all platforms. III. Based on review of the laboratory's QC records, and interview, the laboratory failed to retain the control package inserts for the Immunoassay Plus Control lots in use for two of two years reviewed. Findings follow. A. The Immunoassay Plus Control package insert for Lot 85320 was requested on September 5, 2024 at 1215 hours but not provided. B. Interview with Technical Consultant #1 on September 5, 2024 at 1215 hours confirmed the package insert was not retained. D5400 ANALYTIC SYSTEMS -- 2 of 14 -- CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer instructions, quality control (QC) records, LIS report, interview, and pre-survey paperwork, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems in Chemistry for two of two years. Findings follow. 1. The laboratory failed to have control procedures that detected immediate errors for Alanine Transaminase (ALT), Amylase (Amy), Aspartate Transaminase (AST), Chloride (Cl), Cholesterol (Chol), Creatine Kinase (CK), Iron (Fe), Phosphorus (Phos), Potassium (K), Sodium (Na), Blood Urea Nitrogen (BUN), and Uric Acid (UA) (refer to D5441). KEY: LIS = Laboratory Information System 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 review of laboratory policy and procedure, quality control (QC) records, LIS report, presurvey paperwork, and interview, the laboratory failed to follow its own procedures for evaluating QC on the Siemens Sysmex CA 600 series for activated Partial Thromboplastin Time (APTT) for three out of three out of range values obtained from March 2024. Findings follow. A. Review of the laboratory's policy and procedure titled Lab.8545 Quality Control Program for Coagulation, revised 12/01 /2017, under Policy, stated, "4. At least 2 levels of control must be run on a daily basis. In Coagulation Section, ensure reliability and accuracy of testing process. 5. Document the results of the controls for each test and