Laboratory Corporation Of America Holdings

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Laboratory Corporation of America Holdings, CLIA ID 19D0462635, on July 24, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation by surveyor, review of the laboratory's policies, manufacturer's instructions, patient instrument printouts, patient final test reports, and interview with personnel, the laboratory failed to follow their policy for complete blood count (CBC) instrument flags for four (4) of six (6) patients reviewed. Findings: 1. Observation by surveyor during the laboratory tour on July 24, 2024 at 9:01 am revealed the laboratory utilizes the Sysmex XS-1000 i for CBC testing. 2. Review of the laboratory's "Hematology Specimen Confirmation" policy revealed the following: a) "All CBC/diff parameters will be reviewed for flags." b) " Any parameters with flags will be repeated. Note results were repeated on the report. If flags remain after repeat, the the entire CBC will be sent to the reference laboratory for testing. Do not report any CBC results. Notify client in the event testing needs to be sent out to let them know that the results will be delayed." 3. Review of the manufacturer's "Flagging Interpretation Guide" revealed the "asterisk (*) indicates these results may be unreliable and should be confirmed according to your laboratory protocol prior to reporting. This may include scanning a peripheral smear or performing a manual differential." 4. Review of random selection of patient instrument printouts and final Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- test reports revealed the following patients' repeated results had instrument flags and were not sent to a reference laboratory for further testing: a) June 28, 2023: Patient 3725127; Flags: "Atypical Lympho?" and "HGB Defect?"; asterisk (*) next to the results for neutrophils, lymphocytes, and monocytes b) April 12, 2024: Patient 4341082; Flags: "Blasts?;" asterisk (*) next to the results for neutrophils, lymphocytes, and monocytes c) April 19, 2024: Patient 4151450; Flags: "Atypical Lympho?" and "HGB Defect?;" asterisk (*) next to the results for neutrophils, lymphocytes, and monocytes d) April 30, 2024: Patient 4206787; Flags: "Immature Gran?" and "Atypical Lympho? ;" asterisk (*) next to the results for neutrophils, lymphocytes, monocytes, eosinophils, and basophils 5. In interview on July 24, 2024 at 12:21 pm, the Laboratory Director stated the identified patient samples were not sent out to a reference lab for further testing. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Refer to D5401. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification survey was performed on April 19,2023 at Laboratory Corporation of America Holdings, CLIA ID # 19D0462635. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 the laboratory's policies and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following: a) Written quality control procedure for blood culture bottles that included visual inspections b) Complete Blood Count (CBC) instrument flag policy, to include, but not limited to, criteria for blood smear examination and manual differentials 2. In interview on April 19, 2023 at 3:01 pm, Technical Consultant 1 confirmed the laboratory's policies did not include the identified information. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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)

Summary Statement of Deficiencies D0000 An Initial survey was performed on March 23, 2021 at Laboratory Corporation of America Holdings, CLIA ID # 19D0462635. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and personnel records, the laboratory failed to ensure written policies and procedures to assess competency for the Clinical Consultant were followed. Findings: 1. Review of the laboratory's "Competency Assessment Policy" revealed "Employees who fulfill the following roles as outlined by CLIA must have competency assessed based upon their regulatory responsibilities in addition to any testing responsibilities they may have such as: Clinical Consultant (CC), Technical Consultant (TC), Technical Supervisor (TS), General Supervisor (GS), Testing personnel. Competency for non-waived tests is assessed at the following times: a) after training, b)semi-annually during the first year, c) Annually after the first year." 2. Review of personnel records for the Clinical Consultant revealed no documentation of a competency assessment for his duties as Clinical Consultant. 3. In interview on March 23, 2021 at 11:47 am, the Laboratory Director confirmed she did not perform a competency assessment for the Clinical Consultant. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 the laboratory's policies, manufacturer's instructions, and interview with personnel, the laboratory failed to establish complete written policies for Complete Blood Counts (CBC) flags. Findings: 1. Review of the laboratory's "Cell-Dyn Emerald Action" and manufacturer instructions revealed the laboratory did not include the following: a) Complete Blood Counts (CBC) flagging issues that may occur on the Emerald, to include what alternate methods/actions are required per the manufacturer 2. In interview on March 23. 2021 at 12:34 pm, Testing Personnel 1 confirmed the laboratory's policies did not include actions for flags per manufacturer requirements. 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)