Summary:
Summary Statement of Deficiencies 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 record review and staff interview, the laboratory's (lab) test report for histopathology slide interpretation failed to include the lab's name and address for 2 of 3 reports in 2024 and 2025. Findings include: 1. Review on 9/18/2025 of 3 lab test reports for histopathology slide interpretation completed on 5/3/2024, 8/27/2024, and 7 /24/2025 revealed 2 of 3 reports documented the wrong lab and address where the slides were read. 2. Interview on 9/18/2025 at 10:40 a.m. with the Laboratory Director (LD) confirmed the above finding. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on record review and staff interview, the Technical Consultant (TC) failed to perform competency assessments semiannually in the first year for 1 of 1 new testing personnel in 2024 and 2025. Findings include: 1. Review on 9/17/2025 of personnel records revealed 1 new testing personnel (TP1) completed training in October 2024. Further review revealed semiannual competency assessments had not been performed for routine chemistry, urinalysis, endocrinology, toxicology, and serology test systems in 2024 or 2025. 2. Interview on 9/17/2025 2:15 p.m. with the TC confirmed competency assessments had not been performed semiannually for TP1 in 2024 and 2025. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Consultant (TC) failed to perform competency assessments annually for 3 of 4 testing personnel in 2025. Findings include: 1. Review on 9/17/2025 of 4 personnel records revealed 3 (TP2, TP3, TP4) of the 4 personnel were past due for annual competency assessments in 2025 and personnel records for TP2, TP3, and TP4 failed to include the annual competency assessments for routine chemistry, urinalysis, endocrinology, toxicology, and serology test systems in 2025. 2. Interview on 9/17/2025 2:15 p.m. with the TC confirmed competency assessments had not been performed semiannually for TP2, TP3, and TP4 in 2025. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor (TS) failed to perform competency assessments semiannually in the first year for 1 of 1 new testing personnel in 2024 and 2025. Findings include: 1. Review on 9/17/2025 of personnel records revealed 1 new testing personnel (TP1) completed training October 2024. Further review revealed semiannual competency assessments had not been performed for hematology and microbiology tests systems in 2024 or 2025. 2. Interview on 9/17 /2025 2:15 p.m. with the TS confirmed competency assessments had not been performed semiannually for TP1 in 2024 and 2025. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Supervisor (TS) failed to perform competency assessments annually for 3 of 4 testing personnel in 2025. Findings include: 1. Review on 9/17/2025 of 4 personnel records revealed 3 (TP2, TP3, TP4) of the 4 personnel were past due for annual competency assessments in 2025 and personnel records for TP2, TP3, and TP4 failed to include the annual competency assessments for hematology and microbacteriology tests systems in 2025. 2. Interview on 9/17/2025 2:15 p.m. with the TS confirmed competency assessments had not been performed semiannually for TP2, TP3, and TP4 in 2025. -- 3 of 3 --