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 Respiratory Therapy Manager, (RTM), the laboratory failed to 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 646 out of 646 patients tested in the subspecialty of Routine Chemistry from 01/01/2024 through 12/31/2024. Findings Include: 1. Review of the laboratory's policy and procedure titled "Blood Gases" approved 01/01/2024 by the Laboratory Director via signature and date and provided on the date of inspection found the following statements: "b. Orders written as "stat" should be obtained and reported within 30 minutes and follow the reporting process for critical results" "2. Laboratory personnel shall report results of all critical values received to the physician within 30 minutes; only licensed personnel may accept critical values." 2. Review of the laboratory's 2024 Quality Assessment sheets revealed the following: ID# Time for critical value reporting 19309 154 minutes 19318 640 minutes 19522 646 minutes 19663 1191 minutes ID# Time for STAT test completion 19318 52 minutes 19364 31 minutes 19391 76 minutes 19514 54 minutes 19750 37 minutes 19818 67 minutes 3. Review of the laboratory's policy and procedure titled "Quality Assessment Plan" approved 11/01/2024 by the Laboratory Director via signature and date and provided on the date of inspection found the following statements: " Standards 7. Turnaround time is acceptable for each test." "