Summary:
Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review and an interview with the Testing Personnel (TP) #1, the laboratory failed to establish and follow written policies and procedures and document all assessment activities of an ongoing mechanism to monitor, assess, and correct problems identified in the post analytic systems. This deficient practice had the potential to affect 11,300 out of 11,300 patients tested in the specialty of Hematology, and the subspecialties of Routine Chemistry and Endocrinology from 01/08/2025 through 04/29/2025. Findings Include: 1. Review of the laboratory's policy and procedure titled "Quality Management Plan", approved via signature and date by the Laboratory Director on 07/01/2024, found the following statement: "4.12 Quality Indicators The laboratory tracks quality indicators in the pre-analytical, analytical, and post-analytical phases of testing." 2. The inspector requested detailed documentation of post analytic assessment activities which included the quality indicators for pre- analytical, analytical, and post-analytical phases of testing from the TP#1. The TP#1 was unable to provide the requested documents on the date of inspection. The interview occurred on 04/29/2025 at 12:40 PM. 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 --