Comparison of venipuncture and totally implantable venous access device (TIVAD) blood sampling for 38 routine hematology, chemistry, and coagulation tests: toward a standardized protocol for TIVAD sampling

Abstract Objectives Totally implantable venous access devices (TIVAD) are favored owing to their ease of management, aesthetic advantages, high patient satisfaction, and low infection rates. However, there is a notable lack of standardized protocols grounded in robust evidence to ensure the accuracy and reliability of blood test results obtained through TIVAD sampling. Hence, we aimed to develop a standardized protocol for TIVAD blood sampling and evaluate its clinical applicability by comparing venipuncture and TIVAD blood draw values. Methods We developed a 14-item preliminary protocol based on aseptic procedures, discard volume, and TIVAD flushing. The preliminary protocol was implemented in 36 patients with TIVAD to evaluate clinical applicability. Intraclass correlation coefficients (ICCs), Bland–Altman limits of agreement (LOA), and paired t-tests were employed to assess reliability and agreement. Additionally, the relative differences for each analyte were compared against the acceptance criteria based on both the 2024 Clinical Laboratory Improvement Amendments (CLIA) proficiency testing limits and biological variation (BV) standards to evaluate analytical suitability. Results ICC values ranged from 0.953 to 1.000, with 95.4 % of 1,341 paired blood specimens falling within the LOA range, confirming the protocol’s clinical applicability. Although a few blood parameters showed significant differences, nearly all laboratory values remained within clinically acceptable ranges. Conclusions The study findings indicate that our TIVAD blood sampling protocol effectively reduces patient discomfort and risk of venous thrombosis from repeated and prolonged venipuncture while ensuring accurate blood test results.