Diagnostic Pathology Services, Inc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/02/2024. The laboratory was found in compliance with standard level deficiencies cited. The findings were reviewed with the quality assurance specialist at the conclusion of the survey. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on a review of patient frozen section slides and interview with the QA (quality assurance) specialist, the laboratory failed to ensure that patient slides were available for review during the survey for two of nine patients. Findings include: (1) On 05/02 /2024 at 10:00 am, the QA specialist stated the following to the surveyor: (a) The laboratory prepared frozen sections using the Leica CM1850 Cryostat; (b) The slides were stained with H&E (Hematoxylin & Eosin), then reviewed microscopically by the pathologists. (2) A review of patient frozen section slides for nine patients with microscopic interpretations performed in 2022 and 2023 identified slides could not be retrieved for two of nine patients as follows: (a) Patient# HS-22-0001955 - results were reported on 12/27/2022 (b) Patient# HS-23-0001400) - results were reported on 07/28/2023 (3) The QA specialist stated to the surveyor on 05/02/2024 at 12:22 pm, the slides for the two patients could not be located during the survey. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 -- At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the QA (quality assurance) specialist, the laboratory failed to verify the accuracy of slide interpretations at least twice annually during the review period of August 2022 through the current date. Findings include: (1) On 05/02/2024 at 10:00 am, the QA specialist stated the laboratory performed microscopic slide interpretations of H&E (Hematoxylin and Eosin) stained slides from frozen tissues. The tissue would then be observed microscopically; (2) A review of records from August 2022 through the current date identified no evidence the accuracy of slide interpretations had been verified at least twice annually between 08/01/2022 and 02/29/2024; (3) The records were reviewed with the QA specialist who stated on 05/02/2024 at 11:05 am, the slide interpretations had not been verified for accuracy twice annually as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/30/2020. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the histology supervisor at the conclusion of the survey. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on a review of patient frozen section slides and interview with the histology supervisor, the laboratory failed to ensure that patient slides were available for review during the survey for 3 of 12 patients. Findings include: (1) On 11/30/2020 at 10:00 am, the histology supervisor stated the following to the surveyor: (a) The laboratory prepared frozen sections using the Leica CM1850 Cryostat. The slides were stained with H&E (Hematoxylin & Eosin), then reviewed microscopically by a pathologist. (2) The surveyor requested patient frozen section slides for 12 patients with microscopic interpretations performed in 2019 and 2020. Slides could not be retrieved for 3 of 12 patients. The specific dates of service were 04/30/2019, 05/06/2019, and 10 /23/2019; (3) The histology supervisor stated to the surveyor on 11/30/2020 at 11:30 am, the slides for the 3 patients could not be located. D5805 TEST REPORT CFR(s): 493.1291(c) 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 -- 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 review of records and interview with the histology supervisor, the laboratory failed to ensure patient test reports included the name and address of the laboratory location for 1 of 12 patient reports. Findings include: (1) On 11/30/2020 at 10:00 am, the histology supervisor stated the following to the surveyor: (a) The laboratory prepared frozen sections using the Leica CM1850 Cryostat. The slides were stained with H&E (Hematoxylin & Eosin), then reviewed microscopically by a pathologist. (2) The surveyor reviewed 12 patient test reports. The name and address of the laboratory location where the frozen section slide interpretation was performed was not included on the report for 1 frozen section report with a testing date of 10/05 /2020; (3) The surveyor reviewed the findings with the histology supervisor, who stated on 11/30/2020 at 11:45 the name and address of the laboratory was not included on the report. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with the regional quality manager and histology line supervisor at the conclusion of the survey. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the regional quality manager and histology line supervisor, the laboratory failed to document the reactivity of the H&E (Hematoxylin and Eosin) stain with each day of testing. Findings include: (1) At the beginning of the survey, the histology line supervisor stated the laboratory performed microscopic interpretations of histology specimens using H & E stain; (2) The surveyor reviewed 7 patient records when patient slides, stained with H & E stain, had been microscopically reviewed. For 1 of the 7 patients (test date 05/08/17), there was no evidence the reactivity of the stain had been observed for acceptability; (3) The surveyor reviewed the records with the regional quality manager and histology line supervisor, who stated the reactivity of the stain had been observed by the pathologist performing the microscopic interpretation, but had not been documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --