Summary:
Summary Statement of Deficiencies D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) (d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 (Laboratory Personnel Report) Form, patient test reports, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to ensure eight of eight tissue pathology grossing reports reviewed were signed by the laboratory's histopathology technical supervisor (TS). Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report) Form revealed the same individual functioned as both the LD and the TS. 2. Review of eight of eight patient test reports for histopathology grossing failed to be authorized/signed by the laboratory's histopathology TS. Pathology Case: Date of Service: G2024- 000706 05/24/2024 G2024-001378 10/15/2024 G2025-000210 02/19/2025 G2025- 000866 07/08/2025 G2025-001386 11/17/2025 G2026-000011 01/06/2026 G2026- 000329 03/25/2026 G2026-000366 04/07/2026 3. Interview with the LD on 05/19 /2026, at 12:02 pm, confirmed the laboratory failed to ensure eight of eight tissue pathology grossing reports reviewed were signed by the laboratory's histopathology TS. D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of 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 -- specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to maintain a record system that included the identity of the personnel who performed the histopathology specimen grossing for eight of eight patient testing dates reviewed. Findings include: 1. Review of laboratory "Daily Gross Log" sheets for the grossing of histopathology specimens revealed the laboratory failed to identify/document the testing personnel (TP) who performed the grossing on eight of eight histopathology patient testing dates reviewed. Testing/Gross Date: # of specimens grossed: 05/24/2024 19 10/15/2024 15 02/19 /2025 13 07/08/2025 13 11/17/2025 28 01/06/2026 9 03/25/2026 8 04/07/2026 7 2. Interview with the LD on 05/19/2026, at 12:43 pm, confirmed the laboratory failed to maintain a record system that included the identity of the personnel who performed the histopathology specimen grossing for eight of eight patient testing dates reviewed. 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 laboratory director (LD); the laboratory failed to include all the required components of a laboratory test report including the address of the laboratory location where the test was performed on two of eight tissue pathology grossing reports reviewed. Findings include: 1. Review of two of eight tissue pathology grossing reports revealed the laboratory failed to indicate the address of the laboratory location where the grossing was performed. Pathology Case: Date of Service: G2024-001378 10/15/2024 G2025-000210 02/19/2025 2. Interview with the LD on 05/19/2026, at 1:22 pm, confirmed the laboratory failed to include all the required components of a laboratory test report including the address of the laboratory location where the test was performed on two of eight tissue pathology grossing reports reviewed. -- 2 of 2 --