Nicola Pansini

Laboratory network of excellence: enhancing patient safety and service effectiveness

Abstract Clinical laboratories have undergone major changes due to technological progress and economic pressure. While costs of laboratory testing continue to be the dominant issue within the healthcare service worldwide, quality, effectiveness and impact on outcomes are also emerging as critical value-added features. Five Italian laboratories are therefore promoting a network of excellence by investigating markers of effectiveness of laboratory services and sharing their experience of using them in clinical practice. In the present study we report preliminary data on indicators of quality in all phases of the so-called total testing process, the key to evaluating all phases of the total testing process, including the appropriateness of test requests and data interpretation. Initial findings in evaluating pre-analytical causes of specimen rejection in three different laboratories and the effects of introducing three laboratory clinical guidelines are reported. These data should stimulate debate in the scientific community and encourage more clinical laboratories to use the same indicators to improve clinical effectiveness and clinical outcomes within the healthcare service.

Integration between the Tele-Cardiology Unit and the central laboratory: methodological and clinical evaluation of point- of-care testing cardiac marker in the ambulance

Abstract The aim of this study was to identify patients with myocardial necrosis in pre-hospital phase during transport by ambulance, without ST-segment elevation (NSTE) on the ambulance ECG. The analytical performance of the i-STAT® troponin I (cTnI) method was assessed. A total of 53 NSTE ambulance ECG patients admitted to hospital were followed. The ambulance had experimental software able to receive data from the i-STAT device and transmit it to a protected address and server. cTnI mean values from 2.0 to 34μg/L showed a total CV of 3.0–5.6%. The detection limit was 0.016μg/L. A mean cTnI concentration of 0.09μg/L was associated with a CV of 8.0% (decision limit). The i-STAT cTnI method was linear for concentrations from 0 to 35μg/L. There was no effect (p<0.05) of interfering substances. For point-of-care testing (POCT), cTnI was >0.09μg/L in 20 AMI patients (91%). The median ambulance turnaround time (TAT) was 12min and median hospital TAT was 40min, a difference of 28min. The high sensitivity of the i-STAT cTnI method integrated with tele-medicine procedures could play an important role in the management of acute coronary syndrome patients related to the pre-hospital phase (early diagnosis and treatment in the ambulance). These approaches may allow improvements in patient outcomes and continuous monitoring of the POCT network in the central laboratory, thus meeting quality requirements.

Analytical evaluation of the Dade Behring Dimension RxL automated N-Terminal proBNP (NT-proBNP) method and comparison with the Roche Elecsys 2010.

Abstract Methods to quantify B-type natriuretic peptide (BNP) and N-terminal-propeptide (NT-proBNP) in plasma or serum samples are well established. We assessed the analytical performance of the Dimension RxL NT-proBNP method (Dade-Behring). Evaluation of different sample types was carried out. Controls and heparin plasma pools were used to determine the detection limit, precision, and linearity. Sample stability and the effect of interfering substances on the NT-proBNP concentrations were evaluated. Agreement between Dimension RxL and Elecsys 2010 (Roche Diagnostics) NT-proBNP methods was assessed. The influence of age and sex on NT-proBNP concentrations was evaluated in healthy subjects. Heparin plasma should be the matrix of choice. The detection limit was 2.0ng/L. The total imprecision was 2.6–3.6% for concentrations from 231 to 9471ng/L; mean NT-proBNP concentrations of 21 and 15ng/L were associated with coefficients of variation of 9.9% and 14.7%, respectively. The method was linear up to 32,650ng/L. There was no effect of temperature, freeze-thaw cycles and interfering substances. A bias was detected when Dimension RxL and Elecsys 2010 NT-proBNP methods were compared. Age and sex were significantly and independently related to NT-proBNP concentrations. The Dimension RxL NT-proBNP method, like the Elecsys 2010, is suitable for routine use in the diagnosis of heart failure.

Appropriateness of point-of-care testing (POCT) in an emergency department

BACKGROUND Acute coronary syndrome is a major cause of death, morbidity and access in emergency departments (ED). METHODS We evaluated a point-of-care testing (POCT) for the determinations of cardiac markers in an emergency department (ED), defining the clinical efficiency (management of patient with chest pain) and economic effectiveness (rationalization of preanalytical phase) related to data of Core Lab. RESULTS The results of analytical performances showed a good correlation (cTnI r(2)=0.89, myoglobin r(2)=0.84, CK-MB r(2)=0.9) between POCT and Core Lab and a significant decrease of the turn around time (TAT): difference of medians=-54 min, 95% CI from -48 to -60 min. CONCLUSIONS Our data confirmed that the accurate utilization of POCT in the ED assumes an effective triage of patient with chest pain and the improvement of preanalytical phase out of the laboratory (delivery of specimens) and within the laboratory reception, centrifugation. However, efficiency must be linked to methodological and quality control of the Core Lab, mainly through connectivity.

Comparison of hysteroscopic and hysterectomy findings for assessing the diagnostic accuracy of office hysteroscopy

OBJECTIVE To assess the diagnostic accuracy of office hysteroscopy by comparing the hysteroscopic findings with the histologic findings on the hysterectomy specimens. DESIGN Retrospective clinical study. SETTING University-affiliated hospital. PATIENT(S) Review of the hospital records of 443 patients who underwent office hysteroscopy and, within 2 months, hysterectomy. INTERVENTION(S) We compared the hysteroscopic findings (including targeted biopsies) with the histologic findings that were obtained after hysterectomy. The results of this study were then compared with those of a previous study in which we examined the diagnostic accuracy of dilatation and curettage (D&C). MAIN OUTCOME MEASURE(S) We evaluated the diagnostic accuracy of office hysteroscopy. RESULT(S) When compared with the histologic diagnosis of the uterus, the hysteroscopic findings showed a diagnostic sensitivity of 98%, a specificity of 95%, a positive predictive value (PPV) of 96%, and a negative predictive value (NPV) of 98%. Hysteroscopy was found to have a greater diagnostic accuracy than D&C: the sensitivity and the NPV of the two diagnostic procedures were statistically different. CONCLUSION(S) Office hysteroscopy is confirmed as a powerful diagnostic tool, but targeted biopsies, performed with a small diameter operative hysteroscope, must be performed in cases of suspect endometrium to confirm the image-based diagnosis.

Diagnostic accuracy of hysteroscopy in endometrial hyperplasia

OBJECTIVES To determine the diagnostic accuracy of hysteroscopy in the diagnosis of endometrial hyperplasia in women with abnormal uterine bleeding. METHODS From 1993 through 1995, 980 women referred to our institution for abnormal uterine bleeding underwent diagnostic hysteroscopy with eye direct biopsy of the endometrium in case of macroscopic abnormalities. Hysteroscopic features were compared with pathologic findings in order to detect the reliability of the endoscopic procedure. Statistical analysis was performed with the McNemar test. RESULTS Positive predictive value of hysteroscopy in the diagnosis of endometrial hyperplasia accounted for 63%. In fact hysteroscopic diagnosis of endometrial hyperplasia was confirmed at pathologic examination in 81 out of 128 patients. Sensitivity and specificity of the endoscopic procedure accounted for 98% and 95%, respectively. Negative predictive value accounted for 99%, as only two cases of atypical hyperplasia were missed at hysteroscopy. Positive predictive value was higher in postmenopausal patients compared to women in the fertile age (72 vs. 58%). CONCLUSIONS Overall, results appear encouraging, since no case of endometrial hyperplasia was missed by hysteroscopy. The high diagnostic accuracy, associated with a minimal trauma, renders hysteroscopy the ideal procedure for both diagnosis and follow-up of conservative management of endometrial hyperplasia.

Integration between point-of-care cardiac markers in an emergency/cardiology department and the central laboratory: methodological and preliminary clinical evaluation

Abstract To achieve rapid assessment of chest pain in emergency/cardiology departments, a short turnaround time for cardiac marker testing is necessary. Nevertheless, Total Quality Management principles must be incorporated into the management of point-of-care testing (POCT); in this setting we implemented the Stratus CS ® assay as POCT for cardiac markers in our emergency/cardiology department. The analytical performance of the troponin I method was evaluated; information connectivity between the Stratus CS ® data management system and the laboratory information system was implemented and practical training of testing personnel was carried out at the POCT site. A total of 41 non-ST-segment elevation patients admitted to the hospital were followed to evaluate the appropriateness of hospital admission, formulated on the basis of the cardiac troponin-I level measured at the POCT site by clinical staff. Our preliminary clinical data suggest that the high sensitivity of the Stratus CS ® troponin method could play an important role in the early identification of patients with acute myocardial infarction in a low to intermediate-risk population for acute coronary syndrome. Our POCT model suggests that the central laboratory could ensure that the POCT program remains in compliance with quality requirements. Nevertheless, our comparison studies suggest that the implementation of POCT requires a high level of integration between cardiologists and pathologists to guarantee appropriate interpretation of the monitoring results for suspected ACS patients.

Application of a combined protocol for rational request and utilization of antibody assays improves clinical diagnostic efficacy in autoimmune rheumatic disease.

CONTEXT Because of a marked increase in the number of requests for antinuclear antibodies, anti-extractable nuclear antigen antibodies, and anti-double-stranded DNA antibodies for the diagnosis of autoimmune rheumatic disease, guidelines have been proposed for their appropriate use. OBJECTIVE To evaluate in terms of clinical efficacy and cost-benefit ratio the outcome of applying a protocol for the diagnosis of autoimmune rheumatic disease. DESIGN A diagnostic protocol for the rational utilization of second-level tests (anti-extractable nuclear antigen antibodies and anti-double-stranded DNA antibodies) was applied at Hospital Polyclinic beginning January 2004. The appropriateness of 685 consecutive requests received at the clinical pathology laboratory from January to June 2004 was assessed. Patients who underwent these laboratory tests were followed up for 12 months after blood sample drawing. RESULTS Introduction of the protocol led to a significant reduction in the number of second-level tests prescribed (27.9% vs 49.5% for anti-extractable nuclear antigen antibodies; 27.5% vs 56.6% for anti-double-stranded DNA antibodies). After the period of observation, none of the 163 patients who had negative results on the first-level test and were asymptomatic, for whom second-level tests had not therefore been performed, were found to have autoimmune rheumatic disease. In 90.5% (77/85) of patients positive for the second-level tests, clinical confirmation of autoimmune rheumatic disease was obtained. CONCLUSIONS Not only did application of the diagnostic protocol reduce the number of second-level tests performed but it also increased their specificity. Our data thus indicate that the use of shared guidelines by clinical and laboratory specialists yields satisfactory results.

Endometrial Biopsies Using Small-Diameter Hysteroscopes and 5F Instruments: How Can We Obtain Enough Material for a Correct Histologic Diagnosis?

STUDY OBJECTIVE To evaluate the quantity of biopsy tissue obtained by hysteroscopic grasp technique compared with classic punch technique. DESIGN Observational study (Canadian Task Force classification II-2). SETTING University hospital. PATIENTS One thousand two hundred seventy-six women. INTERVENTION Targeted biopsies performed in an office setting using two biopsy forceps, classic spoon and crocodile, and two methods, classic punch and grasp technique. MEASUREMENTS AND MAIN RESULTS With either biopsy forceps, the mean increase in amount of tissue obtained by grasp technique compared with punch technique was statistically significant (p <0.005). With grasp technique, the mean amount of tissue obtained was even larger with crocodile than with spoon forceps. CONCLUSION Targeted biopsy, when performed with the appropriate instrument and applying correct technique, can provide the pathologist with a large amount of tissue (mean 5.7 mm2) that is invariably adequate for histologic examination.

Hysteroscopic polypectomy in the office without anesthesia

Hysteroscopy is a reliable procedure not only for diagnosis, but also for office treatment of uterine pathologies that, until recently, required general or at least topical anesthesia. The vaginoscopic approach without a speculum and tenaculum avoids discomfort to patients and ensures complete compliance. We treated 253 endometrial and cervical polyps with 5F instruments and an office hysteroscope with operative sheath. All polyps were removed on diagnosis, and the women were able to resume their normal activity soon after the procedure. Pretreatment with danazol or gonadotropin-releasing hormone analogs was necessary only for polyps larger than 2 cm. Recurrence at follow-up was 5%.