Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and (re)certification is recommended. Standard level deficiencies were cited. D5805 TEST REPORT CFR(s): 493.1291(c) (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: Based on a random review of patient's test reports from January to May 2025 and staff interview, the laboratory failed to include the address of the testing facility on six of six patient's test reports reviewed. Findings include: 1. A random review of patient's test reports from January to May 2025 revealed the laboratory failed to include the address of the testing facility on the following 6 patient's test reports: Accession #: BA24-104 Reported: 1/21/25 Accession #: MW25-11 Reported: 2/11/25 Accession #: JE25-17 Reported: 3/21/25 Accession #: BA25-145 Reported: 4/10/25 Accession #: SA25-33 Reported: 4/23/25 Accession #: BA25-195 Reported: 5/8/25 2. In an interview on 5/20/25 at 10:23 a.m. in the laboratory, after review of the records, the Operations Manager confirmed the above findings. D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) 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 -- (b)(8)(vi) Assessment of problem-solving skills; and This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 209 form, the laboratory's Employee Competency Forms from December 2024, and staff interview, the technical supervisor failed to document the assessment of problem-solving skills for the initial competency assessment for two of two testing personnel performing high complexity testing. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory identified 2 testing personnel performing high complexity testing in the specialty of Histopathology. 2. A review of the laboratory's Employee Competency Forms revealed that the technical supervisor failed to document the assessment of problem-solving skills for the initial competency assessment for the following testing personnel: - Testing person #1 competency assessment performed December 2024 - Testing person #2 competency assessment performed December 2024 3. In an interview on 5/20/25 at 9:40 a.m. in the laboratory, after review of the records, the Operations Manager confirmed the above findings. -- 2 of 2 --