Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on February 07, 2023. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: I. Based on patient result report reviews and testing personnel (TP) interview, the laboratory failed to include the name and address of the laboratory location where the test was performed. Findings: 1. Review of 3 random patient test reports revealed the lack of the name and address of the testing site on the following reports: a. In-house hematology reports #4264 and # 91568 b. Reference report #12051946 2. Interview with TP#1 in the breakroom on 2/7/23 at 12:39 PM confirmed the findings. II. Based on patient result report review and testing personnel (TP) interview, the laboratory failed to include the the units of measurement. Findings: 1. Review of patient reference report #12051946 revealed the lack of the units of measurement. 2. Interview with TP#1 in the breakroom on 2/7/23 at 12:39 PM confirmed the findings. D5807 TEST REPORT 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 -- CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on patient result report reviews and testing personnel (TP) interview, the laboratory failed to include reference values for tests performed. Findings: 1. Review of 3 random patient test reports revealed the lack of the reference values on the following reports: a. In-house hematology reports #4264 and # 91568 b. Reference report #12051946 2. Interview with TP#1 in the breakroom on 2/7/23 at 12:39 PM confirmed the findings. -- 2 of 2 --