How widely has ANTT been adopted in NHS hospitals and community care organisations in England and Scotland?

BACKGROUND: To the detriment of patient safety, the important clinical competency of aseptic technique has been notoriously variable in practice, and described ambiguously in the literature, internationally. From a UK perspective, attempts have been made to improve patient safety by reducing variability and improving education and practice through standardisation. The Welsh Government mandated Aseptic Non Touch Technique (ANTT®) as a specific national standard in 2015. All healthcare organisations in England are required by the Health and Social Care Act 2008 to have a single standard aseptic technique, demonstrable by the clinical governance indicators of education, training, competency assessment and compliance audit. In Scotland, an education-based initiative was launched by NHS Education for Scotland in 2012. To review the impact of these and other initiatives on the current status of aseptic technique, all NHS trusts in England and NHS health boards in Scotland were assessed under the Freedom of Information procedure. FINDINGS: 93% of NHS trusts in England use a single standard for aseptic technique. In 88% of these trusts the single standard was stipulated as being ANTT. In Scotland, 62% of NHS acute and community care hospitals within health boards use a single standard. In 56% of these, the single standard was ANTT. When including those that use ANTT in combination with other techniques ANTT usage is 73%. CONCLUSION: These data demonstrate significant progress in standardising aseptic technique education, assessment and governance, and confirms ANTT as the de facto aseptic technique used in NHS trusts in England and health boards in Scotland.

Microbiological validation of a robot for the sterile compounding of injectable non-hazardous medications in a hospital environment.

Objectives: To design and execute a comprehensive microbiological validation protocol to assess a brand-new sterile compounding robot in a hospital pharmacy environment, according to ISO and EU GMP standards. Methods: Qualification of the Class-A inner environment of the robot was performed through microbial air and surface quality assessment utilising contact plates, swabs and particulate matter monitoring. To evaluate the effectiveness of the microbial decontamination process (UV rays) challenge test against Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis spores and Candida albicans was used. The challenge Media Fill test was used to validate the aseptic processing. Results: After 3 hours, no microorganisms retained viability. Monitoring inside the equipment evidenced complete absence of microorganisms. The Media Fill test was always negative. Conclusions: According to our results, the APOTECAunit meets the requirements for advanced aseptic processing in the hospital pharmacies and the pharmaceutical industry in general, providing advantages in terms of safety for patients compared with conventional procedures of parenteral preparation production. The protocol has demonstrated to be a comprehensive and valuable tool in validating, from a microbial point of view, a sterile-compounding technology. This study might represent an important benchmark in developing a contamination control strategy, as required, for example, in the Performance Qualification of the GMP in the case of drug manufacturing.

Practising asepsis during dressing changes in community settings.

Community nurses often face challenges when going into a patient's home to change a dressing, particularly if the surroundings are likely to be contaminated by multiple strains of bacteria or viruses. For housebound patients, cleaning the house can be an extremely difficult task due to physical or mental illness. They may also experience a large amount of exudate as a result of possibly debilitating painful wounds, for example, leg ulcers, and may be prone to infection as a result of the difficulties posed in keeping a dressing covering a heavily exuding wound in a possibly unclean environment. Therefore, it is of the utmost importance that a community nurse or healthcare worker be able to change the wound dressing in the cleanest and most supportive manner. This article covers the most recent guidance and research relevant to the practice of aseptic or clean technique when changing dressings in the community.

Acute surgical wound-dressing procedure: Description of the steps involved in the development and validation of an observational metric.

The aim of this study was to develop an observational metric that could be used to assess the performance of a practitioner in completing an acute surgical wound-dressing procedure using aseptic non-touch technique (ANTT). A team of clinicians, academics, and researchers came together to develop an observational metric using an iterative six-stage process, culminating in a Delphi panel meeting. A scoping review of the literature provided a background empirical perspective relating to wound-dressing procedure performance. Video recordings of acute surgical wound-dressing procedures performed by nurses in clinical (n = 11) and simulated (n = 3) settings were viewed repeatedly and were iteratively deconstructed by the metric development group. This facilitated the identification of the discrete component steps, potential errors, and sentinel (serious) errors, which characterise a wound dressing procedure and formed part of the observational metric. The ANTT wound-dressing observational metric was stress tested for clarity, the ability to be scored, and interrater reliability, calculated during a further phase of video analysis. The metric was then subjected to a process of cyclical evaluation by a Delphi panel (n = 21) to obtain face and content validity of the metric. The Delphi panel deliberation verified the face and content validity of the metric. The final metric has three phases, 31 individual steps, 18 errors, and 27 sentinel errors. The metric is a tool that identifies the standard to be attained in the performance of acute surgical wound dressings. It can be used as both an adjunct to an educational programme and as a tool to assess a practitioner's performance of a wound-dressing procedure in both simulated and clinical practice contexts.

Survey to explore understanding of the principles of aseptic technique: Qualitative content analysis with descriptive analysis of confidence and training.

BACKGROUND: In many countries, aseptic procedures are undertaken by nurses in the general ward setting, but variation in practice has been reported, and evidence indicates that the principles underpinning aseptic technique are not well understood. METHODS: A survey was conducted, employing a brief, purpose-designed, self-reported questionnaire. RESULTS: The response rate was 72%. Of those responding, 65% of nurses described aseptic technique in terms of the procedure used to undertake it, and 46% understood the principles of asepsis. The related concepts of cleanliness and sterilization were frequently confused with one another. Additionally, 72% reported that they not had received training for at least 5 years; 92% were confident of their ability to apply aseptic technique; and 90% reported that they had not been reassessed since their initial training. Qualitative analysis confirmed a lack of clarity about the meaning of aseptic technique. CONCLUSION: Nurses' understanding of aseptic technique and the concepts of sterility and cleanliness is inadequate, a finding in line with results of previous studies. This knowledge gap potentially places patients at risk. Nurses' understanding of the principles of asepsis could be improved. Further studies should establish the generalizability of the study findings. Possible improvements include renewed emphasis during initial nurse education, greater opportunity for updating knowledge and skills post-qualification, and audit of practice.

U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies.

The reasons for which pharmaceutical compounding is the focus of intense state and federal scrutiny are now well known. Compounders are faced with an ever-increasing need to prove, by objective standards, the safety, purity, and potency of the formulations they dispense. They must also demonstrate their compliance with regulations often based on current good compounding practices designed for the pharmaceutical industry. In the U.S. today, rigorous unannounced state and federal inspections of compounding facilities are occurring more and more frequently. To achieve a successful outcome, communicating clearly and effectively with inspectors and having ready access to the information they request are as critical as proving compliance. This article describes the author's experience with an unannounced United States Food and Drug Administration inspection of his 503A compounding facility and his response to the findings. Readers will learn what to expect during such an inspection, how to prepare for that event, and how to achieve an excellent outcome. Those who would like more information about any of the topics presented are invited to contact the author at the address provided at the close of this article.

Aseptic technique for accessing central venous catheters: applying a standardised tool to audit 'scrub the hub' practices.

BACKGROUND: To reduce the risk of infections associated with indwelling central venous catheters (CVCs), practices for hub disinfection have been widely promoted. The objective of this study was to design and implement a standardised tool to monitor compliance with 'scrub the hub' practices at an Australian centre. METHODS: Review of existing literature and recommendations regarding scrub the hub practices was performed to identify nine key components that could be audited by direct observation of staff in clinical areas. The tool was reviewed by stakeholders in infection prevention, infectious diseases and senior nursing roles prior to pilot evaluation. RESULTS: Twenty attempts to access a CVC were audited. In all instances, scrub the hub practices were commenced. However, a 15-second scrub was performed in only 60% of cases, and the hub was permitted to dry in only 65% of instances. With respect to maintaining an aseptic field, the overall compliance was 40%, and compliance was lowest for maintenance of a non-touch technique for key parts and sites, and hand hygiene practices following CVC access. CONCLUSIONS: A standardised clinical audit tool for monitoring aseptic access of CVCs enabled identification of practices amendable to targeted intervention and education, such as duration of hub disinfection. This tool would be readily utilised to facilitate quality improvement initiatives in a range of healthcare contexts, including high-risk inpatient and ambulatory care settings.

Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes.

OBJECTIVE: The purpose of this study was to evaluate the contamination rate of media-fill products either prepared automated with a robotic system (APOTECAchemo™) or prepared manually at cytotoxic workbenches in the same cleanroom environment and by experienced operators. Media fills were completed by microbiological environmental control in the critical zones and used to validate the cleaning and disinfection procedures of the robotic system. METHODS: The aseptic preparation of patient individual ready-to-use injection solutions was simulated by using double concentrated tryptic soy broth as growth medium, water for injection and plastic syringes as primary packaging materials. Media fills were either prepared automated (500 units) in the robot or manually (500 units) in cytotoxic workbenches in the same cleanroom over a period of 18 working days. The test solutions were incubated at room temperature (22℃) over 4 weeks. Products were visually inspected for turbidity after a 2-week and 4-week period. Following incubation, growth promotion tests were performed with Staphylococcus epidermidis. During the media-fill procedures, passive air monitoring was performed with settle plates and surface monitoring with contact plates on predefined locations as well as fingerprints. The plates got incubated for 5-7 days at room temperature, followed by 2-3 days at 30-35℃ and the colony forming units (cfu) counted after both periods. The robot was cleaned and disinfected according to the established standard operating procedure on two working days prior to the media-fill session, while on six other working days only six critical components were sanitized at the end of the media-fill sessions. Every day UV irradiation was operated for 4 h after finishing work. RESULTS: None of the 1000 media-fill products prepared in the two different settings showed turbidity after the incubation period thereby indicating no contamination with microorganisms. All products remained uniform, clear, and light-amber solutions. In addition, the reliability of the nutrient medium and the process was demonstrated by positive growth promotion tests with S. epidermidis. During automated preparation the recommended limits < 1 cfu per settle/contact plate set for cleanroom Grade A zones were not succeeded in the carousel and working area, but in the loading area of the robot. During manual preparation, the number of cfus detected on settle/contact plates inside the workbenches lay far below the limits. The number of cfus detected on fingertips succeeded several times the limit during manual preparation but not during automated preparation. There was no difference in the microbial contamination rate depending on the extent of cleaning and disinfection of the robot. CONCLUSION: Extensive media-fill tests simulating manual and automated preparation of ready-to-use cytotoxic injection solutions revealed the same level of sterility for both procedures. The results of supplemental environmental controls confirmed that the aseptic procedures are well controlled. As there was no difference in the microbial contamination rates of the media preparations depending on the extent of cleaning and disinfection of the robot, the results were used to adapt the respective standard operating procedures.

Choosing a Vial Processing Line for Aseptic Compounding: Part 1.

Equipment systems that enable compliance with stringent state and federal compounding requirements are a topic of increasing interest to U.S. pharmacists. Of those equipment types, an aseptic vial processing line offers unique benefits (especially to 503B compounding pharmacies and small contract manufacturers of aseptic pilot-size batches) if the volume of sterile preparations dispensed offsets the cost of purchase, installation, and maintenance. In this article, the reasons for and the process of selecting an aseptic vial processing line for use in 2 independent 503B compounding pharmacies are presented, the operation of our choice of equipment is described, and specifications for the components of that line are listed. In part 2 of this series, the success of our choice and its effect on sterile compounding in our facilities will be reported.

Basics of Sterile Compounding: Personnel Requirements for Sterile Compounding.

The risk of microbial contamination during sterile product preparation would be practically non-existent were people not involved in the preparatory process. This article discusses why people are the main source of microbial contamination and what safeguards need to be present to minimize this source.

Quality Assurance and Quality Control, Part 2.

The tragedy surrounding the New England Compounding Center and contaminated steroid syringe preparations clearly points out what can happen if quality-assurance and quality-control procedures are not strictly practiced in the compounding of sterile preparations. This article is part 2 of a two-part article on requirements to comply with United States Pharmacopeia general chapters <797> and <1163> with respect to quality assurance of compounded sterile preparations. Part 1 covered documentation requirements, inspection procedures, compounding accuracy checks, and part of a discussion on bacterial endotoxin testing. Part 2 covers sterility testing, the completion from part 1 on bacterial endotoxin testing, a brief dicussion of United States Pharmacopeia <1163>, and advances in pharmaceutical quality systems.

How we make cell therapy in Italy.

In the 21st century scenario, new therapeutic tools are needed to take up the social and medical challenge posed by the more and more frequent degenerative disorders and by the aging of population. The recent category of advanced therapy medicinal products has been created to comprise cellular, gene therapy, and tissue engineered products, as a new class of drugs. Their manufacture requires the same pharmaceutical framework as for conventional drugs and this means that industrial, large-scale manufacturing process has to be adapted to the peculiar characteristics of cell-containing products. Our hospital took up the challenge of this new path in the early 2000s; and herein we describe the approach we followed to set up a pharmaceutical-grade facility in a public hospital context, with the aim to share the solutions we found to make cell therapy compliant with the requirements for the production and the quality control of a high-standard medicinal product.

Quality Control Testing for Tracking Endotoxin-Producing Gram-Negative Bacteria during the Preparation of Polyvalent Snake Antivenom Immunoglobulin.

UNLABELLED: Snake bites represent a serious public health problem, particularly in rural areas worldwide. Antitoxic sera preparations are antibodies from immunized animals and are considered to be the only treatment option. The purification of antivenom antibodies should aim at obtaining products of consistent quality, safety, efficacy, and adherence to good manufacturing practice principles. Endotoxins are an integral component of the outer cell surface of Gram-negative bacteria. They are common contaminates of the raw materials and processing equipment used in the manufacturing of antivenoms. In this work, and as a part of quality control testing, we establish and examine an environmental monitoring program for identification of potential sources of endotoxin-producing Gram-negative bacteria throughout the whole steps of antivenom preparation. In addition, we follow all the steps of preparation starting from crude plasma till finished product using a validated sterility and endotoxin testing.Samples from air, surface, and personnel were collected and examined through various stages of manufacturing for the potential presence of Gram-negative bacteria. A validated sterility and endotoxin test was carried out in parallel at the different production steps. The results showed that air contributed to the majority of bacterial isolates detected (48.43%), followed by surfaces (37.5%) and then personnel (14%). The most common bacterial isolates detected were Achromobacter xylosoxidans, Ochrobactrum anthropi, and Pseudomonas aeruginosa, which together with Burkholderia cepacia were both also detected in cleaning water and certain equipment parts. A heavy bacterial growth with no fungal contamination was observed in all stages of antivenom manufacturing excluding the formulation stage. All samples were positive for endotoxin including the finished product.Implementation and continued evaluation of quality assurance and quality improvement programs in aseptic preparation is essential in ensuring the safety and quality of these products. LAY ABSTRACT: Antitoxic sera preparations are the only treatment option for snake bites worldwide. They are prepared by immunizing animals, usually horses, with snake venom and collecting horse plasma, which is then subjected to several purification steps in order to finally prepare the purified immunoglobulins. Components of the bacterial cell wall known as endotoxins can constitute a potential hazardous contamination known as pyrogen in antisera, which can lead to fever and many other adverse reactions to the person subjected to it.In this work, we monitored the environment associated with the different steps of production and purification of snake antivenom prepared from immunized horses. We examined the air quality, surface, and personnel for possible sources of contamination, particularly the presence of Gram-negative bacteria, which is the major source of endotoxin presence. We also monitored all stages of preparation by sterility and endotoxin testing. Our results showed that air contributed to the majority of bacterial isolates. Sterility testing revealed the presence of bacterial contamination in all the intermediate steps, as only the final preparation after filtration was sterile. Endotoxin was present in all tested samples and the final product. Good manufacturing practice procedures are essential in any facility involved in antisera production.

Sterile Product Packaging and Delivery Systems.

Both conventional and more advanced product container and delivery systems are the focus of this brief article. Six different product container systems will be discussed, plus advances in primary packaging for special delivery systems and needle technology.

Absceso post-inyección en personas que asistieron a la Unidad de Salud La Joya. Tegucigalpa, Honduras / Post-Injection Abscess in patients attending health Unit La Joya, Tegucigalpa, Honduras

La presente investigación es sobre absceso post-inyección en el centro de salud La Joya. Objetivo: Establecerlos factores de riesgo deabscesopost-inyección en pacientesque asistieron ala unidad de salud. Material y Métodos: Tipo de estudio retrospectivo transversal. Se revisó un total de 3,256 expedientes de personas que acudieron a la unidad de salud La Joya, Tegucigalpa, de enero a octubre de 2012, se elaboró una hoja de registro para recolectar información de los expedientes clínicos, los formularios de atención ambulatoria, y entrevistas telefónicas con los pacientes que presentaron absceso post inyección. Así mismo, se elaboró una encuesta de 12 preguntas cerradas aplicada al personal de la unidad de salud. Para determinar el grado de contaminación y agentes existentes en el área de tratamiento de la unidad de salud, se tomó muestras para cultivo microbiológico del personal de salud, del ambiente y del material y equipo. Resultados: 15 pacientes resultaron con absceso en la región glútea, el 93% fueron del sexo femenino, en su mayoría obesas (60%), de 4-59 años de edad (80%), con higiene personal diaria deficiente. La mayor parte del personal afirmó utilizar las normas de asepsia en la aplicación de inyecciones y mantener los principios básicos de desinfección de superficies en el área de tratamiento. En el análisis microbiológico se reportó crecimiento bacteriano en todas las muestras tomadas, incluyendo las muestras de manos del personal de salud. Conclusión: Son diversos los factores de riesgo para la formación de abscesos glúteos post inyección, se señalan factores particulares del paciente, factores relacionados con el personal y los propios del área de inyecciones del centro de salud La Joya; las medidas de asepsia y de aseo en el área, reduce la incidencia de abscesos glúteos post-inyección y de sus complicaciones...(AU)

End-preparation assessments and tests for compounded sterile preparations.

Outsourcing has become a necessity to obtain sterile products that are currently on backorder. Because of the expense of outsourcing sterile compounding, pharmacy leadership in health systems are now considering the option of insourcing and batch preparing compounded sterile preparations, which can be a viable option for a health system. It can significantly decrease drug-spending costs, and the pharmacy has a complete record of the compounding process. The key to preparing high-quality, safe, sterile preparations and meeting United States Pharmacopeia standards is end-preparation assessments and tests.