Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted from May 16, 2024 to May 31, 2024. PEDIATRIC ASSOCIATES INC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. Cited the following Condition: D6168 - Testing Personnel 493.1487 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to retain records for Quality Control (QC) for one out 25 days reviewed during November 2023. Findings included: 1-Review of Quality Control/Quality Assurance (QA) logs for November 2023 revealed that the high control was repeated on 11/17/2023 and the testing personnel documented the identified problem as "High Control out of range" with