Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 05/20/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. 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 review of laboratory's patient test reports and staff interview, the laboratory failed to ensure the name and address of the testing laboratory was included on the patient's final report for four of four of final reports reviewed for the one test performed by the laboratory in 2025, grossing of histology samples. Findings included: 1. Review of four random patient test reports from January to May 2025 revealed the laboratory's final reports did not include the name or address of the testing facility where grossing of histology samples was performed. Reviewed reports included reports for the following samples: Accession: SS25-40 Patient MRN: 84497 Collected: 01/13/2025 Accession: SS25-81 Patient MRN: 84877 Collected: 02/10 /2025 Accession: SS25-146 Patient MRN: 84887 Collected: 03/22/2025 Accession: SS25-227 Patient MRN: 86331 Collected: 04/26/2025 2. In an interview on 05/20 /2025 at 1020 hours in the laboratory, the laboratory's Operations Manager (as 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 -- indicated on submitted Survey Entrance/Exit Conference document) confirmed the findings. D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) (b)(8)(vi) Assessment of problem-solving skills; and This STANDARD is not met as evidenced by: Based on review of laboratory's personnel records, policies/procedures and staff interview, the laboratory's technical supervisor failed to include assessment of problem-solving skills during competency assessment for one of two testing personnel employed by the facility in 2025, Testing Person number 2 (TP2). Findings included: 1. Review of laboratory's personnel records revealed the laboratory did not document TP2's problem-solving skills during their competency assessment conducted on 05/01 /2025. 2. Review of laboratory's policies/procedures revealed the laboratory did not have protocols in place for competency assessment of its testing personnel. 3. In an interview on 05/20/2025 at 1000 hours in the laboratory, the laboratory's Operations Manager (as indicated on submitted Survey Entrance/Exit Conference document) confirmed the findings. -- 2 of 2 --