Italian Accreditation Research Articles

Accreditation and Quality in the Italian National Health Care System: a 10 years long review


 
 
 Background: Italian accreditation and OECI accreditation are recognized as tools to ensure an adequate level of quality in healthcare setting. The aim of our study was to review the scientific literature about these topics looking for original experiences of accreditation. 
 Methods: In March-April 2019 we conducted a search on original peer-reviewed papers in the electronic database PubMed (MEDLINE). The key search terms were “accreditation AND Italy”, “hospital accreditation AND Italy”. We looked for studies published between 2009 and 2019, reporting information about Accreditation experiences. 13. 
 Results: The literature search yielded 562 publications. Finally, we identified 16 manuscripts eligible for the review. The studies were published between 2010 and 2016; they were conducted from 2007 to 2015; they involved a minimum of 1 to a maximum of 183 centres located in different Italian regions and cities. They concerned different fields such as oncology, haematology, health physics, health direction, paediatrics, and surgery. Accreditation led to a general enhancement of quality, and offered suggestions for further improvement. 
 Conclusion: Each healthcare system should achieve the best possible levels of quality and safety. 
 Accreditation, combined with further strategies could ensure the highest level of quality. 
 

Progress with the work program of ISO/REMCO during 2020

The 43rd meeting of the Reference Material Committee of ISO, ISO/REMCO, that was scheduled to take place in Milan, Italy, from 30 June to 3 July 2020 with Accredia, the Italian accreditation body and INRIM, the Italian Metrology Institute as the hosts, was cancelled due to the COVID-19 pandemic. This report shares the details of the important decision that was taken by the ISO Technical Management Board (TMB) in December 2020 to transform ISO/REMCO into an ISO technical committee, ISO/TC 334, Reference materials. The background that led to the decision is provided as well as the implications of the decision for the future of the development of guidance for the production and use of reference materials. The report also gives an update on the progress with the work program of the committee during the past year and the strategy for the future work of the committee.

Validation of a Novel Commercial ELISA Test for the Detection of Antibodies against Coxiella burnetii.

Q fever is a zoonosis caused by Coxiella burnetii, a Gram-negative pathogen with a complex life cycle and a high impact on public and animal health all over the world. The symptoms are indistinguishable from those belonging to other diseases, and the disease could be symptomless. For these reasons, reliable laboratory tests are essential for an accurate diagnosis. The aim of this study was to validate a novel enzyme-linked immunosorbent assay (ELISA) test, named the Chorus Q Fever Phase II IgG and IgM Kit (DIESSE, Diagnostica Senese S.p.A), which is performed by an instrument named Chorus, a new device in medical diagnostics. This diagnostic test is employed for the detection of antibodies against C. burnetii Phase II antigens in acute disease. Our validation protocol was performed according to the Italian Accreditation Body (ACCREDIA) (Regulation UNI CEI EN ISO/IEC 17025:2018 and 17043:2010), OIE (World Organization for Animal Health), and Statement for Reporting Studies of Diagnostic Accuracy (STARD). Operator performance was evaluated along with the analytical specificity and sensitivity (ASp and ASe) and diagnostic accuracy of the kit, with parameters such as diagnostic specificity and sensitivity (DSp and DSe) and positive and negative predictive values (PPV and NPV), in addition to the repeatability. According to the evaluated parameters, the diagnostic ELISA test was shown to be suitable for validation and commercialization as a screening method in human sera and a valid support for clinical diagnostics.

Report of a Multilateral Accurate Measurement Comparison on a High-Precision Multimeter to Evaluate the Traceability Transfer from INRIM in the Field of Low-Frequency Electrical Quantities

As the calibration activity of modern electrical secondary laboratories operating in the five low-frequency quantities is carried out by means of high-precision digital multimeters (DMMs), it is of fundamental importance for their correct technical surveillance through suitable inter-laboratory comparisons (ILCs). The laboratory for calibration of multifunction electrical instruments of the National Institute of Metrology Research (INRIM-Lab) provides bilateral and multilateral ILCs involving high-precision DMMs to check the measurement capabilities of electrical laboratories. In particular, this paper deals with the last multilateral ILC that INRIM-Lab provided and carried out as reference measurements’ provider to which took part twelve Italian-accredited laboratories divided into two loops. The ILC was involved in a high-precision 8.5 digit high-precision DMM to be verified in a grid of about forty measurement points. The 2σ relative uncertainties of the INRIM-Lab calibrations ranged from 1.6 × 10−6 to 1.5 × 10−4, while those of the laboratories ranged from 2.0 × 10−6 to 2.2 × 10−3. The ILC had satisfactory results confirming the correctness of both the dissemination from INRIM and the accreditation process by the Italian accreditation body for calibration laboratories.

Validation of a one-step PCR assay for the molecular identification of Echinococcus granulosus sensu stricto G1\u2013G3 genotype

The Italian National Reference Center for Echinococcosis (CeNRE, Sassari, Italy) set up a diagnostic protocol of “one-step-PCR” useful for the detection of E. granulosus sensu stricto (E.g.s.s.) and the identification of its genotype (G1–G3). The purpose of this work was to perform the validation of the “PCR E.g.s.s.” method. The procedures were performed employing the criteria of the World Organization for Animal Health as well as of the Italian Accreditation Body (ACCREDIA) based on the Regulation UNI CEI EN ISO/IEC 17025. Positive DNA samples belonging to E. granulosus, E. ortleppi, E. multilocularis, E. canadensis species were used for the experiments. Analytical specificity evidenced primer pairs Cal (Calreticulin l gene of 1001 bp) with an specificity higher respect to Ef1 (Elongation-Factor 1 Alpha gene of 706 bp) and NAD (Dehydrogenase-subunit 1 gene of 219 bp). The analytical sensitivity presented the capability to detect a very low amount of parasite DNA corresponding to a concentration of 12.5 pg/µl; accuracy and precision related to the operator performance, along with repeatability and reproducibility, evidenced high concordance among results and demonstrated an excellent κ values of Cohen. According to the good performance related to the evaluated parameters, the method “PCR E.g.s.s.” was suitable for the validation procedure, and consequently, to be undergone to the accreditation process. In conclusion, the results demonstrated an elevated robustness and reliable features of the “PCR E.g.s.s.” able to perform a rapid diagnosis of E. granulosus in only “one step”, hence, it is likely to avoid the sequencing step.

The INRIM Role of Inter-laboratory Comparison Provider for Electrical Power and Energy at Industrial Frequency: A Two-Year Activity Report

The technical surveillance of secondary calibration laboratories accredited according to the ISO/IEC 17025 standard for electrical power and energy at industrial frequency is very important, as these measurements are the basis of the commercial relations between an electricity supplier and a user. An effective technical surveillance requires the execution of inter-laboratory comparisons (ILCs). With them, it is possible to verify the competence of the laboratories and the correctness of the dissemination process from the national standards of power and energy, usually maintained at national metrology institutes, to these laboratories. The paper deals with the ILCs that the National Institute of Metrological Research (INRIM) provided and carried out as reference measurements provider for Italian accredited laboratories for power and energy (active and reactive) at industrial frequency. The ILCs were carried out involving various instrument types and at different uncertainty levels. The 2σ relative uncertainties of the INRIM calibrations ranged from 1.0 × 10−4 to 1.5 × 10−3. The ILCs had satisfactory results confirming the correctness of both the dissemination from INRIM and the accreditation process by the Italian accreditation body for calibration laboratories.

ISO 9001 certification and corporate performance of Italian companies

PurposeThe purpose of this paper is to verify a possible relationship between quality management system certification according to ISO 9001 standard and risk of failure of Italian companies.Design/methodology/approachA synthetic index which summarize the most crucial economic/financial aspects of the studied companies is assumed as the response variable of a statistical model for studying the effects of four specific factors: certification, company size, regional development and manufacturing sub-sector. The analysis is conducted on a sample of Italian companies belonging to different manufacturing sub-sectors. The used data are obtained from the database Aida® by Bureau van Dijk and from the database of the Italian accreditation body Accredia. The study is based on analysis of variance (ANOVA) and contingency tables.FindingsPreliminary results of ANOVA show that only company size, regional development and manufacturing sub-sector can be considered fully significant. Furthermore, the major conclusion from the analysis of contingency tables is that ISO 9001 certification is connected to the legal status (active, not active) of a company only for a portion for the studied manufacturing sub-sectors. Hence, the scenario is quite variegated and a significant positive interaction between certification and corporate performance is not always confirmed.Research limitations/implicationsAlthough the research shows some interesting results, it is liable to extensions and improvements. In particular, at the current exploratory level, it is limited to a specific period of time and considers only the Italian sector, but it could be extended to a wider number of years and to European and international level.Practical implicationsThe study opens a way for a number of important questions about the meaning, usefulness and effectiveness of ISO 9001 certification. In particular, it may be time to ask whether the paradigm of certification actually needs a radical rethink.Originality/valueThis work represents a first exploratory attempt to correlate the risk of failure with the achievement of ISO 9001 certification. There are several similar works in literature which, however, focus mainly on sectorial aspects of the corporate background.

Analysis of a national comparison in the field of electrical low dc resistance

In this paper a measurements comparison between the National Institute of Metrological Research (INRIM), acting as pilot Laboratory, and nineteen Italian Secondary Calibration Laboratories in the field of low dc Electrical Resistance is presented and discussed. This comparison was carried out on commission by the Italian Accreditation Body of Calibration Laboratories ACCREDIA-DT. As traveling standards three Tinsley mod 3504C four terminal standard resistors to be calibrated in oil respectively at 5A and 20A (1mΩ), 1A and 5A (10mΩ), 0.1A and 1A (100mΩ) were involved. The temperatures at the measurements thermal regimen allowed a correction at 23°C of the results. The comparison results, shown graphically and as distribution of the normalized errors, were satisfactory, except in the case of a Laboratory whose measurements were outside its accreditation field.

Accreditation of a forensic genetics laboratory in Italy

Although in Italy DNA analysis is used since the beginnings, the introduction of a specific legislation had a very important impact for the quality of the results. Only authorized laboratories can now implement the database with genetic profiles; these labs have to follow ISO/IEC standard and according to the Council Framework Decision 2009/905/JHA of 30 November 2009 and the Recommendation 7 of ENFSI this standard is the ISO17025/2005 accreditation. Since December 22th 2009, ACCREDIA is the only appointed Italian Accreditation authority can issue the accreditation certificate. There is no rule to define the ISO test method for the study of DNA polymorphisms in forensics, thus each laboratory should build their own analytical system, reliable and reproducible, through its own internal validation. Here, we focus on some points of the accreditation process developed in our laboratory concerning internal validation protocol.

Testing the suitability of different high-performance liquid chromatographic methods to determine aflatoxin M1 in a soft fresh Italian cheese

Aflatoxin M1 (AFM1) is a toxic undesirable compound in milk. AFM1 affinity for caseins causes a concentration effect during milk process for dairy transformation. In spite of this, no official method of analysis, nor maximum tolerance level for aflatoxin M1 in cheese have been established. Thus, the aim of this work was to test the suitability of different HPLC methods for the AFM1 quantification in soft cheese samples at three different contamination levels (low, medium and high, at respectively nearly 30, 100 and 250 ng/kg). Nine participants were selected among Italian laboratories accredited by the Italian accreditation body (ACCREDIA) for HPLC toxin analysis. They were asked to analyze samples applying the method routinely used. The different applied methods were compared, and precision and accuracy parameters were evaluated. The main differences among HPLC procedures were registered at the level of extraction step. The use of an enzymatic digestion for the extraction of the toxin from cheese seemed to be particularly advantageous and the use of immunoaffinity columns seemed to be determinant for the improvement of sensitivity at low contamination levels. In general, the applied methods well discriminated the 3 levels of contamination, even though they performed better at the medium and high concentration levels (100 and 250 ng/kg) than at the low one (30 ng/kg). In fact relative standard deviation for reproducibility at low level was higher (60.1%) than the same value at medium and high levels (22.8% and 28.9%, respectively).

Laboratory accreditation in Italy for reference solution production of sucrose in water

The accreditation of Chemifarm srl laboratory for the calibration of two characteristics on the same aqueous solution has been achieved. The process has been executed by the Italian accreditation body for calibration laboratories (SIT). This is the first example of a producer of certified reference solutions in Italy. The solutions are mixtures of sucrose in water at several concentrations and are characterised for refractive index in the range of 1.33299 to 1.38115 and for mass fraction of sucrose in the range of 0 to 30 (commercially expressed in Brix degrees). Both traceability paths, obtained through refractometric and gravimetric methods, are reported. Furthermore, the paper describes the approach adopted to match the criteria based on ISO Guide 34 and ILAC-G 12, the documents with requirements for certified reference material producers, in compliance with those of ISO/IEC 17025, the norm for the laboratory accreditation.

Some considerations on handling the calibration results of capacitance membrane gauges

Capacitance diaphragm gauges (CDG) are widely used also as transfer instruments; consequently, they need to be referred frequently to primary systems mostly in the (1000–0.1) Pa range where no other accurate gauges are available. They must be characterized individually since a general rule on their metrological behaviour is not possible. Various CDGs are calibrated at IMGC for the Italian Accreditation Service. The aim of the present paper is to demonstrate that, for each gauge and after the first calibrations, it is possible to arrive at an equation which represents the calibration coefficient as a function of pressure and is based on a reduced number of experimental points; as a consequence the time for a complete calibration procedure is cut down. One of the four gauges we examined, for which many calibration curves were available, was considered for a complete evaluation; then the evaluation model was applied to other gauges.