Improving safety in blood transfusion using failure mode and effect analysis.

BACKGROUND: One of the medical areas where errors can have more serious consequences is the process of blood transfusion. We used failure mode and effect analysis (FMEA) for evaluating potential failures and improving transfusion safety in a medium-size urban hospital with a highly complex transfusion service. STUDY DESIGN AND METHODS: Each failure mode was evaluated using the likelihood of occurrence, severity of the effect, and probability of detection. The obtained results allowed each failure to be prioritized and decisions to be made in an organized manner to determine solutions. We define measures and indicators that allow the comparison of their results in a longer time period than most of the previous studies. RESULTS: The most important failures were those regarding 1) transmitting information about the transfusion request, 2) patient identification, 3) sample identification, 4) cross-matching ordered tests, 5) transfusing blood components, 6) completing and sending the transfusion control document, and 7) reporting of transfusion reactions. The application of the FMEA methodology allowed implementation of safety measures and monitoring of the measures using indicators, including the mandatory records of the hemovigilance system. There was a 56% improvement in the risk prioritization numbers in the second stage of the FMEA. CONCLUSION: FMEA allows for identification of factors that reduce safety in this hospital, analysis of the causes and consequences of these errors, design of corrective measures, and establishment of indicators to monitor their application. The FMEA methodology can help other institutions to identify their own specific vulnerabilities.

Impact of a patient blood management program within an Orthogeriatric care service.

BACKGROUND: Patient blood management (PBM) performs multidisciplinary strategies to optimize red blood cell (RBC) transfusion. Orthogeriatric share care models (surgeon and geriatrician manage the patient together from admission) have the goal of improving outcomes in hip fracture patients. MATERIAL AND METHODS: A prospective observational study was conducted. Patients aged ≥70 years undergoing hip fracture (HF) surgery were consecutively included. When admitted on the orthogeriatric service a PBM protocol was applied based on: perioperative antithrombotic management, intravenous iron sucrose administration and restrictive transfusion criteria. Risk factors, clinical and functional effects of transfusion and its requirements were assessed to audit our model. RESULTS: A total of 383 patients participated (women, 78.8%; median age, 86 (82-90) years). 210 patients (54.8%) were transfused. Age (OR = 1.055, 95% CI 1.017-1.094; p = 0.004) and Hemoglobin (Hb) level on admission (OR = 0.497, 95% CI 0.413-0.597; p < 0.001) were found to be significant risk factors for transfusion. Transfusion increased length of stay (b = 1.37, 95% CI 0.543-2.196; p = 0.001) but did not have an effect on other variables. DISCUSSION: The PBM program established within an orthogeriatric service showed positive outcomes in terms of clinical complications, mortality, delirium or functional recovery in transfused patients, whereas it did not impact on shorter length of stay. The risk of transfusion on admission was predicted with the lower Hb levels on admission, along with the age of the patients. New measurements as homogenous restrictive transfusion criteria, a single-unit RBC transfusion and the assessment of the intravenous iron efficacy are need to be applied as a result of the high transfusion requirements.

Presence of acute and chronic renal failure in patients with paroxysmal nocturnal hemoglobinuria: results of a retrospective analysis from the Spanish PNH Registry.

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening blood disease. With the advent of eculizumab treatment, renal function has substantially improved, although no data from real-world clinical practice are available. An observational, retrospective, multicenter study was conducted in Spain on clinical data obtained from outpatient visits of patients with PNH (Spanish PNH Registry) who had experienced acute (ARF) or chronic (CRF) renal failure. Of the 128 patients registered (April 2014), 60 were diagnosed with classic PNH. Twenty-seven (45.0%) patients with a mean age of 48.5 (±16.2) years had renal failure, ARF or CRF, and were included in this study. Near half of the patients (n = 13; 48.1%) presented with ARF alone, 33.3% (n = 9) had CRF with episodes of ARF, while 18.5% (n = 5) were diagnosed with CRF alone. For patients with diagnosis of PNH and renal failure (n = 27), the median time to the first ARF episode was 6.5 (CI 95%; 2.2, 14.9) years, whereas the median to the diagnosis of CRF was 14.5 (CI 95%; 3.8, 19.2) years after the diagnosis of PNH. Patients with ARF (n = 22) were treated with eculizumab and did not experience new episodes of ARF, except for one patient with sepsis. Of the patients with CRF, two received treatment without experiencing further episodes of ARF. Sixteen patients who completed treatment (11 with ARF and 5 with ARF + CRF) recovered from the episode of ARF or from CRF. Of the remaining patients treated with eculizumab, one patient improved from stages III to II, three patients stabilized without showing disease progression, and one patient progressed from stages III to IV. Treatment with eculizumab in PNH patients has beneficial effects on renal function, preventing ARF and progression to CRF.

Hb La Coruña [beta38(C4)Thr-->Ile]: a new hemoglobin variant leading to familial polycythemia.

Hb La Coruña [beta38(C4)Thr --> Ile] is a new hemoglobin (Hb) variant that has an increased oxygen affinity. Clinically, this Hb leads to erythrocytosis. Hb La Coruña is an electrophoretically silent variant that can be detected by reversed phase high performance liquid chromatography (HPLC) and characterized by DNA sequencing. The patient was a 22-year-old Spanish male whose family lived in La Coruña, in the northwest of Spain. His mother was also a carrier.

First Spanish case of thalassemia major due to a compound heterozygosity for the IVS-II-848 (C --> A) and codon 39 (C --> T) mutations of the beta-globin gene.

This report describes the first case in Spain of a severe form of beta-thalassemia (thal) due to a compound heterozygosity for the IVS-II-848 (C --> A) and the nonsense codon 39 (C --> T) mutations. Five members of a family from Cadiz (southern Spain) were studied. The proband was an 8-year-old girl diagnosed as anemic at the age of 13 months. Her father had the codon 39 (C --> T) mutation and her mother the C --> A change at nucleotide (nt) 848 of IVS-II. Haplotype analysis showed that the proband was a compound heterozygote for haplotypes I [+ --> + +] and VII [+ --> +]. This is the first description in Spain of the IVS-II-848 (C --> A) mutation. It appears, from restriction fragment length polymorphism (RFLP) analysis, that this mutation has a different origin in the various populations, where it was found. This observation shows that in this case the association of a beta(0)- and a beta(+)-thal mutation does not lead to a thalassemia intermedia but to a severe thalassemia with very low hemoglobin (Hb) levels. From a therapeutic point of view, early introduction of a transfusion regimen may improve the clinical picture of these children, allowing for better development and growth.

Frequency of the C282Y and H63D mutations of the hemochromatosis gene (HFE) in a cohort of 1,000 neonates in Madrid (Spain).

For centuries in Europe, population movements have contributed to ethnic groups, cultures, and consequently, inheritance mixing. There are certain genetic diseases such as hereditary hemochromatosis whose distribution is directly related to the population movements. The objective of the present investigation was to determine the C282Y and H63D mutation frequency of the HFE gene in a cohort study of 1,000 neonates in the Community of Madrid (Spain), thus contributing to the HFE gene mutations distribution research in Europe and establishing the origin of the mutations in Spain. The allelic frequency of C282Y mutation was 1.7% (CI 95% 1.1-2.3) and the H63D allele was present in 16.4% of chromosomes (CI 95% 14.8-18). In Spain, the presence of C282Y mutation and its distribution could be due more to Celtic than to Viking legacy, whereas it is assumed that the one in relation to the H63D variant occurred in the Basque Country during the Paleolithic Period.