Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted from 08/21/2024 to 08/28/2024 found the ANCILLARY PATHWAYS, LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and staff interview, the laboratory failed to ensure that the patient report included the name and address of the laboratory that performed the Technical Component (TC) for 8 out of 8 reports reviewed (P#1, P#2, P#3, P#4, P#5, P#6, P#7 and P#8) in 2023-2024, and failed to identify the laboratory name and address of the laboratory that performed the Professional Component (PC) for 1 out of 8 reports reviewed for the period listed above. Findings Included: 1-Review of the 8 patient reports revealed the following: -Report for patients: P#1 (dated 12/22/2023, P#2 (dated 02/12/2024), P#3 (dated 02/19/2024, P#4 (dated 03/01/2024, P#5 (dated 03 /25/2024). P#6 (dated 03/27/2024, P#7 (dated 04/23/2024), P#8 (dated 05/15/2024) failed to include the name and address of the laboratory that performed the TC. - P#1 Report failed to include the name and address of the laboratory that performed the Professional Component (PC). During an interview on 08/21/2024 at 11:30 am, with Chief Executive Officer, she confirmed that the reports of reference failed to include 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 name and address of the laboratory that performed the TC and failed to list the name and adress of the laboratory that performed PC for P#1. -- 2 of 2 --