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 review of patient test reports, lack of documentation, and interview with the testing personnel one (TP1); the laboratory failed to include the name and address of the location where interpretations of slides for histopathology testing were performed for six of six patient test reports reviewed. Findings include: 1. Review of the CMS- 209 (Laboratory Personnel Report) revealed two TP (TP: A & B) performed slide interpretations for testing in the subspecialty of histopathology. 2. Interview with TP1, on 08/18/2026, at 1:51 pm, revealed histopathology slides are interpreted on-site and at an alternative location. 3. Review of six of six patient test reports reviewed found the laboratory failed to indicate the name and address of the performing laboratory on the final test reports. Accession#: Date of testing: ODH-25-1988 03/10/25 ODH-25- 0835 07/10/25 ODH-26-0824 03/09/26 ODH-26-0835 03/10/26 ODH-26-2451 06/22 /26 ODH-26-3151 07/30/26 4. Interview with TP1 on 08/18/2026, at 4:24 pm, confirmed the laboratory failed to include the address of the location where interpretations of slides for histopathology were performed for six of six patient test reports reviewed. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES 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): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, the CMS-209 (Laboratory Personnel Report), laboratory records, lack of documentation, and interview with the testing personnel one (TP1); the technical supervisor (TS) failed to evaluate competency assessments for three of five TP performing microscopic potassium hydroxide (KOH) wet mount and microscopic scabies wet mount testing in 2025. Findings include: 1. Review of laboratory policies and procedures revealed, "Lab Personnel Policy", which stated, "Technical Supervisor 1. Responsibilities viii. Evaluating the competency of all testing personnel and assuring that the staff maintained their competency to perform test procedures and report test results promptly, accurately and proficiently." and "Competency Assessment Policy", which stated, "Assess and document the performance of individuals responsible for testing semiannually during the first year and annually thereafter". 2. Review of the CMS- 209 (Laboratory Personnel Report) revealed five TP (TP3, TP4, TP5, TP6, and TP7) performed microscopic KOH and scabies wet mount testing. 3. Review of laboratory competency evaluation records revealed no competency evaluations were performed by the TS, as identified on the CMS-209, for three of five TP (TP3, TP5, and TP7) for microscopic KOH and scabies testing in 2025. 4. Interview with TP1 on 08/18/2026, at 12:29 pm, confirmed the TS failed to evaluate competency assessments for three of five TP performing microscopic KOH and scabies testing in the laboratory in the year 2025. -- 2 of 2 --