Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(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 observation, record review and interview, the laboratory failed to label seven out of seven patient (PT#1-PT#7) final reports with the laboratory name and address to reflect where the testing was performed. Findings Included: 1.) Tour of the laboratory on 11/21/2022 at 11:45am, revealed the laboratory was performing frozen section with cryostat and reading slides with a microscope. 2.) Review of Pathology Patient Information revealed the following: a. PT#1- Frozen section was performed on 3/18/2021 with a Pathology MAP (grossing), b. PT#2- Frozen section was performed on 1/11/2021 with a Pathology MAP (grossing), c. PT#3 -Frozen section was performed on 10/11/2022 with a Pathology MAP (grossing), d. PT#4- Frozen section was performed on 9/23/2022 with a Pathology MAP (grossing), e. PT#5- Frozen section was performed 7/26/2022 with a Pathology MAP (grossing), f. PT#6- Frozen section was performed 4/5/2022 with a Pathology MAP (grossing), g. PT#7- Frozen section was performed 11/09/2021 with a Pathology MAP (grossing), 3.) Review of 2021 -2022 Surgical Pathology Reports revealed the following: a. PT#1- The Surgical Pathology Report dated 3/19/2021, contained the final patient report but had the address of another laboratory. b.PT#2- The Surgical Pathology Report dated 1/13 /2021 contained the final patient report but had the address of another laboratory. 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 -- PT#3 - The Surgical Pathology Report dated 10/13/2022 contained the final patient report but had the address of another laboratory. d.PT#4- The Surgical Pathology Report dated 9/26/2022 contained the final patient report but had the address of another laboratory. e.PT#5 - The Surgical Pathology Report dated 7/27/2022 contained the final patient report but had the address of another laboratory. f. PT#6- The Surgical Pathology Report dated 4/7/2022 contained the final patient report but had the address of another laboratory. g.PT#7 - The Surgical Pathology Report dated 11/11/2021 contained the final patient report but had the address of another laboratory. 4.) Review of "2014 Laboratory /Sugicare Quality Management Program", signed by Clinical Consultant on 7/29/2021, revealed the policy did not require the laboratory performing frozen section, grossing, and slide reading to be listed on the final report. 5.) During a phone call interview with SP-3 (clinical consultant) on 11/21 /2022 at 1:30 PM, they confirmed the laboratory performs grossing, frozen sections and slide reading at this location and the location was not listed on the final report. -- 2 of 2 --