Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Review of final patient reports and interview of facility personnel found that the laboratory failed to ensure the name and address of the laboratory performing testing appeared on seven of seven final reports received between May 5, 2023 and May 17, 2023. The findings included: 1. Review of six of seven final test reports found the laboratory failed to include the name and address of the reference laboratory performing the testing as follows: MRN 1921572 - Alpha-1-Antitrypsin and Phenotype (collected: 05/01/2023 1144 verified: 05/05/2023 1609) Comments: Performed at 01: [laboratory name and address omitted] Performed at 02: [laboratory name and address omitted] Resulting Labs: [laboratory name and address omitted] MRN 385520 - Hepatitis C Antibody (collected: 05/15/2023 0904 verified: 05/16 /2023 1014) Comments: Performed at 01: [laboratory name and address omitted] Resulting Labs: [laboratory name and address omitted] MRN 279540 - SCL 70 Antibody (collected: 05/15/2023 1049 verified: 05/16/2023 0912 Comments: Performed at 01: [laboratory name and address omitted] Resulting Labs: [laboratory name and address omitted] MRN 1672308 - Hepatitis B Surface Ab (collected: 05/15 /2023 1150 verified: 05/16/2023 0718 Comments: Performed at 01: [laboratory name and address omitted] Resulting Labs: [laboratory name and address omitted] MRN 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 -- 5853308 - IgM and IgG (collected: 05/15/2023 1640 verified:05/17/2023 0814) Comments: Performed at 01: [laboratory name and address omitted] Resulting Labs: [laboratory name and address omitted] MRN 277777 - T-SPOT, TB (collected: 05/15 /2023 0924 verified: 05/17/2023 1647) Comments: [laboratory name and address omitted] Resulting Labs: [(laboratory name only) omitted] MRN 4654518 - T-SPOT, TB (collected: 05/15/2023 0906 verified: 05/17/2023 1651) Comments: [laboratory name and address omitted] Resulting Labs: [(laboratory name only) omitted] 2. During interview of the laboratory director conducted May 18, 2023 at 12:35 PM, she confirmed that the name and address of the reference laboratory performing each of the tests listed was not clearly defined on the final report. -- 2 of 2 --