Nieuwe rollen in nieuwe organisaties

Van bedrijven en individuen wordt verwacht dat zij zich onderscheiden van anderen. Met lethargie en apathie wordt geen genoegen meer genomen. Ook bedrijfsbibliotheken moeten vooruit. Ze moeten bijdragen aan de leer van de continue groei en tegemoetkomen aan het beeld van de nieuwe economie. Daan Boom laat zijn licht schijnen op management en strategie van de bedrijfsbibliotheek van de toekomst

Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part C:Applying risk assessment and risk control in practice

OBJECTIVES: To describe the application of the model described in part A and part B of this series of articles for risk assessment (RA) and risk control (RC) of non-sterility during aseptic handling. The model was applied in nine hospital pharmacies.METHODS: The starting point was an audit of each hospital pharmacy. The determined risk reduction and remaining risks were entered into a risk assessment model. The corresponding risk prioritisation numbers (RPNs) for each source of risk were calculated and these values were summed up to a cumulative RPN. Subsequently, all hospital pharmacies started an improvement programme, using the risk assessment as input. Results of aseptic process simulation (APS) and microbiological monitoring (MM) were also collected. The participants were informed about their progress of risk reduction and results of APS and MM during the study period. At the end of the study (about 4 years after the start), a final assessment was executed by using a checklist with risk reducing measures for each source of risk. Additional risk reduction and remaining risks were put in an RA and RC template and corresponding RPN values and a new cumulative RPN were determined.RESULTS: At the start of the study differences in cumulative RPN values were relatively small (from 630 to 825). At the end they were relatively great (from 230 to 725), which illustrates a different sense of urgency for reducing the risk of non-sterility. Of all the risk reducing measures, a yearly audit of all operators had the greatest impact on reducing the risk of non-sterility. Except for glove prints, there was no correlation between process improvement (lower cumulative RPN) and results of microbiological controls.CONCLUSION: A systematic and science-based reduction of the risks of non-sterility can be done by using a checklist with risk reducing measures and an RA &amp; RC template. Prospectively, the relevance of each risk reducing measure can be demonstrated by RPN calculations. Microbiological controls are an important part of the overall assurance of product quality. However, the results are less useful for assessing the risk of non-sterility.</p

Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part A:Risk assessment

OBJECTIVES: To determine prospectively the sources of risk of non-sterility during aseptic handling and to quantify the risks of each of these sources. METHODS: A risk assessment (RA) of non-sterility according to Failure Mode and Effect Analysis was executed by a multidisciplinary team of (hospital) pharmacists and technicians, a consultant experienced in aseptic processing and an independent facilitator. The team determined the sources of risk of non-sterility, a 5 point scale for severity, occurrence and detection, and risk acceptance levels. Input about general applied risk reduction was collected by audits in 10 hospital pharmacies. The results of these audits were used for determining the remaining risks. The results, as well as scientific information and the experience of the team members, was used to determine scores for severity, occurrence and detection. RESULTS: Multiplying the scores for severity, occurrence and detection results in the risk prioritisation number (RPN) which is a relative value of the remaining risks of non-sterility for each source. Incorrect disinfection techniques of non-sterile materials and the chances of touching critical spots were estimated as the greatest risks. The risk of non-sterility via the airborne route was low. RPN values were helpful in prioritising measures for additional risk reduction (this will be described in an accompanying article). CONCLUSION: The RA, described here, was a systematic survey related to all sources of risk of non-sterility during aseptic handling. The determined RPN values were helpful in prioritising measures for additional risk reduction

Improving the aseptic transfer procedures in hospital pharmacies. Part B:evaluation of disinfection methods for materials with a non-sterile surface

Objectives To improve the disinfection methods for materials with a non-sterile surface to be used in aseptic handling. Methods The surface bioburden on ampoules (A) and injection vials (IV) is determined by contact plates and total immersion. The occurrence of spore-forming bacteria is determined by strain colouring and matrix-assisted laser desorption ionisation-time of flight mass spectrometry. The disinfection procedures of non-sterile materials in 10 hospital pharmacies are judged by observing. Results After wiping according to local disinfection methods, the mean surface bioburden determined by contact plates in 10 hospital pharmacies is 0.36 (plastic A), 0.50 (glass A) and 0.29 colony-forming unit (cfu) (IV). The observers found great differences in accuracy of wiping and degree of wetting the sterile gauzes. After improved wiping with commercially available alcohol impregnated sterile wipes and a two-towel technique (one-step TT disinfection), the mean surface bioburden determined by contact plates is 0.03 (plastic A), 0.2 (glass A) and 0.13 cfu (IV). Further improvement can be reached by submerging A and IV in ethanol 70% followed by improved wiping (two-step TT disinfection), but still micro-organisms will remain (mean surface bioburden determined by total immersion is 0 (plastic A) and 0.3 cfu (IV); glass A not determined). Two-step TT disinfection is more labour intensive. Spilling of alcohol is another disadvantage. However, we presume one-step TT disinfection is effective enough in daily practice. Routine surface bioburden determinations have to prove this. The effectiveness of the combination of spray and wipe is not examined because we observed a quick disappearance of alcohols from vertical as well as horizontal surfaces, which shortens the contact time to far below the advised 2 min. Spore-forming bacteria disappear as quickly as other micro-organisms during disinfection by alcohols. Conclusion Local disinfection procedures can be improved. Complete removal of micro-organisms from materials with a non-sterile surface, even after two-step TT disinfection, is impossible. Routine surface bioburden determinations have to prove if one-step TT disinfection is effective enough

Nieuwe rollen in nieuwe organisaties : Een veelbelovende toekomst

Van bedrijven en individuen wordt verwacht dat zij zich onderscheiden van anderen. Met lethargie en apathie wordt geen genoegen meer genomen. Ook bedrijfsbibliotheken moeten vooruit. Ze moeten bijdragen aan de leer van de continue groei en tegemoetkomen aan het beeld van de nieuwe economie. Daan Boom laat zijn licht schijnen op management en strategie van de bedrijfsbibliotheek van de toekomst

Intranet als geïntegreerd informatiesysteem

Nieuwe technologische mogelijkheden stellen bedrijven in staat hun activiteiten anders in te richten en uit te voeren. Daarbij aansluitend worden nieuwe, aangepaste organisatievormen geïntroduceerd ter ondersteuning van het werk binnenshuis en buiten de deur: flexibele werkplekken, thuiswerk, just-in-time, work-flow management en virtuele organisaties zijn enkele van deze nieuwe begrippen. Toegepast op de bibliotheek- en documentatieafdeling kan de nieuwe technologie ook deze werkprocessen deels of geheel integreren in de interne bedrijfsapplicaties. In de meeste ondernemingen neemt de bedrijfsbibliotheek en haar applicaties vanouds een eigen plaats in, met een aparte infrastructuur en specifieke software programma’s, niet gekoppeld met andere bedrijfsapplicaties of met toeleveranciers

Informatiespecialist speelt nauwelijks rol bij ‘voorkennis-informatie’

SINDS 1 JANUARI VAN dit jaar is de wet toezicht effecten verkeer uitgebreid met betrekking tot het handelen met voorkennis. Het Financieele Dagblad van 30 januari en 9 februari jl. stelt dat analistenrapporten koersgevoelige informatie bevatten. Gebruik van dergelijke openbare informatie voor het handelen in effecten zou strafbaar zijn. Daarmee wordt in beginsel voldaan aan de kenmerken van handelen met voorwetenschap. Wie zijn de mensen die als eerste over dergelijke informatie beschikken en welke maatregelen worden er genomen tegen het misbruiken van voorkennis? Is de informatiespecialist de persoon die beschikt over koersgevoelige informatie