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.

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.

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.

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.

Applying the Bookmark method to medical education: standard setting for an aseptic technique station.

INTRODUCTION: The purpose was to evaluate the Bookmark standard-setting method for use on a performance-based assessment in medical education. METHODS: We compared cutscores for Aseptic performance assessment using the modified Angoff, Hofstee and modified Bookmark methods. RESULTS: The Angoff produced a cutscore of 62%, SD=18 and a percent passing (pp)= 64%. The Hofstee cutscore was 71%, SD=7 and pp=46%. Bookmark mean cutscores were 65.9% SD=10.7 and pp=42% for advanced beginners; 83.6%, SD=9.2 and pp=17% for competent and the proficient category resulted in a cutscore of 96.4% SD=3.9 and pp=1%. Faculty judges found the Bookmark method to be an easy and acceptable method. CONCLUSIONS: The Bookmark method was acceptable to faculty, has reasonable quality metrics when compared to other methods and can be a practical tool for establishing standards in performance-based examinations. The Bookmark method could be useful for establishing multiple levels of competency using the Dreyfus criteria.

Teaching aseptic technique for central venous access under ultrasound guidance: a randomized trial comparing didactic training alone to didactic plus simulation-based training.

BACKGROUND: Our goal was to determine whether simulation combined with didactic training improves sterile technique during ultrasound (US)-guided central venous catheter (CVC) insertion compared with didactic training alone among novices. We hypothesized that novices who receive combined didactic and simulation-based training would perform similarly to experienced residents in aseptic technique, knowledge, and perception of comfort during US-guided CVC insertion on a simulator. METHODS: Seventy-two subjects were enrolled in a randomized, controlled trial of an educational intervention. Fifty-four novices were randomized into either the didactic group or the simulation combined with didactic group. Both groups received didactic training but the simulation combined with didactic group also received simulation-based CVC insertion training. Both groups were tested by demonstrating US-guided CVC insertion on a simulator. Aseptic technique was scored on 8 steps as "yes/no" and also using a 7-point Likert scale with 7 being "excellent technique" by a rater blinded to subject randomization. After initial testing, the didactic group was offered simulation-based training and retesting. Both groups also took a pre- and posttraining test of knowledge and rated their comfort with US and CVC insertion pre- and posttraining on a 5-point Likert scale. Subsequently, 18 experienced residents also took the test of knowledge, rated their comfort level, and were scored while performing aseptic US-guided CVC insertion using a simulator. RESULTS: The simulation combined with didactic group achieved a 167% (95% confidence interval [CI] 133%-167%) incremental increase in yes/no scores and 115% (CI 112%-127%) incremental increase in Likert scale ratings on aseptic technique compared with novices in the didactic group. Compared with experienced residents, simulation combined with didactic trained novices achieved an increase in aseptic scores with a 33.3% (CI 16.7%-50%) increase in yes/no ratings and a 20% (CI 13.3%-40%) increase in Likert scaled ratings, and scored 2.5-fold higher on the test of knowledge. There was a 3-fold increase in knowledge and 2-fold increase in comfort level among all novices (P < 0.001) after combined didactic and simulation-based training. CONCLUSION: Simulation combined with didactic training is superior to didactic training alone for acquisition of clinical skills such as US-guided CVC insertion. After combined didactic and simulation-based training, novices can outperform experienced residents in aseptic technique as well as in measurements of knowledge.

A national survey of prevention of infection in obstetric central neuraxial blockade in the UK.

We conducted a postal survey of all consultant-led UK obstetric anaesthetic units in August 2009, to assess the standard of aseptic technique used for neuraxial blocks. One hundred and sixty-four units responded giving a response rate of 76%; 93% of units (149/160) follow recommended precautions and attach a bacterial micropore filter to the epidural catheter. Epidural top-ups are provided by 72% (116/162) of units, with about two thirds using premixed solutions (of local anaesthetic with opioid) in a variety of ways: 51% (57/111) via a continuous infusion pump; 47% (52/111) by a prefilled syringe; and 23% (25/111) by multiple use of a premixed bag of solution. For spinals, 91% of units (149/164) add diamorphine: of these 85% (126/149) draw the diamorphine from non-sterile-wrapped ampoules. If required to draw opioid from a non-sterile-wrapped ampoule, 86% (119/138) of units use a micropore filter and 21% (29/138) wipe the ampoule neck with an alcohol swab. Although sepsis secondary to neuraxial block in obstetric practice is uncommon (declared by 8.5% of units over an unspecified period of time), there is scope for further improvement.

Cytotoxics compounded sterile preparation control by HPLC during a 16-month assessment in a French university hospital: importance of the mixing bags step.

The Centralized Chemotherapy Reconstitution Unit (CCRU) of Paul Brousse Hospital Pharmacy Department assessed the reliability of its Cytotoxics Compounded Sterile Products (CCSP) preparation method in order to improve its CCSP quality assurance system. Five cytotoxic drugs - gemcitabine, 5-fluorouracil, docetaxel, paclitaxel, and oxaliplatin - were assayed by high performance liquid chromatography (HPLC) to determine CCSP concentration. During the observation period, 23,892 CCSP were prepared. Overall, 12,964 preparations contained one of the five analyzed drugs; 7382 (56.9%) out of 12,964 CCSP were analyzed by HPLC; 646 (8.8%) out of 7382 concentrations were outside ± 20% of the prescribed dose; 544 (84.2%) out of 646 were post-administration results and could not be verified. Out of 102 (15.8%) pre-administration results that were re-tested after re-shaking, 94 (92.2%) were found to be acceptable upon re-testing, and 8 (7.8%) were confirmed to be unacceptable and needed to be re-compounded. The 8.8% of tested CCSP were outside ± 20% of the prescribed dose, but extrapolating the results on re-tested CCSP, we can say that our CCSP preparation is reliable with an estimation of only 0.7% of 7382 CCSP analyzed, confirmed as being ± 20% outside the prescribed dose. Nevertheless, this ± 20% magnitude of error should be reduced. Based on pre-administration results, the primary cause of concentration errors appeared to be insufficient mixing of the finished product. Most CCSP dosages occurred after it had been administered, the organization should, therefore, be improved to include testing all CCSP prior to administration. Pharmaceutical companies should endeavor to manufacture compounded injectible drugs in a 'ready to use' form and provide vehicles in accurate volumes in order to improve compounding precision.

District nurses' and aseptic technique: where did it all go wrong?

Concerns have been raised about whether it is possible to perform aseptic procedures within a community setting. Hallett (2000) has described how community nurses often have a fatalistic view about whether such procedures can really be performed at home. At the same time there has been an increase in the number of patients being cared for at home who need interventions which must adhere to the principles of asepsis. While it has been acknowledged for some time that community nurses must be resourceful and adapt the procedure, the view that community nurses cannot really perform aseptic procedures is a fairly new phenomenon. This article explores the reasons why concerns about the performance of aseptic procedures in the community may have arisen and what steps can be taken to address these concerns to ensure that care at home is both safe and effective.

ANTT: an essential tool for effective blood culture collection.

Blood culture collection is an important and topical intravenous procedure for the management of suspected infection. Contaminated samples can lead to 'false positive' results, and inappropriate clinical interventions, which can compromise patient outcome and incur significant expense to healthcare organizations. The contamination of blood culture samples by ineffective aseptic technique has been estimated to be as high as 10% (Department of Health (DH), 2007a). Aseptic Non Touch Technique (ANTT) is a ground-breaking global initiative designed to improve outcomes of aseptic technique through the rationalization and standardization of practice. The ANTT blood culture collection guideline provides nationally peer-reviewed guidance on safe and efficient blood sampling for laboratory culture. The guideline complements the DH's (2007a) Saving Lives summary of best practice for taking blood cultures, providing health professionals with a standardized method of complying with best practice guidance from the epic project (Pratt et al, 2007).

ANTT: a standard approach to aseptic technique.

Aseptic technique is the most commonly performed infection prevention procedure in healthcare; it is also probably the most critical. This article looks at the aseptic non touch technique (ANTT) model for reducing healthcare-associated infections (HCAI). It outlines the principles of ANTT and the approach to practice, and discusses the challenges health professionals still face in reducing HCAIs.

Common breaks in sterile technique: clinical perspectives and perioperative implications.

Prevention of health care-associated infections, specifically surgical site infections, is a fundamental responsibility of the perioperative team. Breaks in sterile technique can and do occur, even for the most conscientious perioperative practitioners. Surgical site infections are associated with unnecessary patient pain and suffering and increased lengths of hospital stay and health care costs. Prevention of surgical site infections, therefore, takes on great significance in today's dynamic health care environment. Key responsibilities of perioperative nurses are to recognize and correct common breaks in sterile technique that are made in preparation for and during a surgical procedure and to implement methods to prevent future occurrences.

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.

Variations in aseptic technique and implications for infection control.

Healthcare-acquired infections (HAIs) are a serious concern, costing the NHS 1 billion pounds a year and causing 5000 deaths annually despite increased funding. A contributing factor is the variety of aseptic techniques in use in different hospitals and even within a single hospital. These cause problems for healthcare workers as well as increasing the risk of HAI. This article examines a number of traditional approaches to aseptic technique, highlighting their differences and the implications for infection control. It concludes that improvement in aseptic technique could be achieved by implementation of a single unified approach to aseptic technique that can be standardized and audited annually, such as the aseptic non-touch technique (ANTT), which has been recommended for adoption throughout the UK. It ends with suggestions for measures that could be introduced and strengthened to improve aseptic technique, and ultimately reduce the rate of HAI.

Infection associated with central venous or epidural catheters: how to reduce it?

PURPOSE OF REVIEW: Central venous catheters are a leading source of nosocomial bloodstream infection with an estimated 10% mortality. Infection associated with epidural catheterization is an uncommon but devastating complication. Diagnosis of spinal epidural abscess requires a high index of suspicion and imaging techniques such as MRI. Early diagnosis and treatment will minimize permanent damage, but primary prevention should be the aim, which depends on proper patient evaluation and use of full aseptic precautions. RECENT FINDINGS: Recent studies suggest that epidural infection is no longer as rare a complication as once thought and may be increasing. It is not clear whether this increase is related to an increase in reporting, an overall increase in the total number of epidurals (especially extended use) being performed, or a true increase in infection rate. Implementation of multistep prevention programs has been shown to decrease central venous catheter-related bloodstream infection rate. Antiseptic or antibiotic-impregnated central venous catheters are effective in decreasing central venous catheter-related bloodstream infections. SUMMARY: Healthcare worker education and training are essential to create standardization of aseptic care. Continuous surveillance is necessary for identifying lapses in infection-control practices.

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.

Microbial diversity in pharmaceutical product recalls and environments.

Identification of microbial contaminants in product recalls and environmental samples provides important information on the possible contamination sources and distribution of microbial species in pharmaceutical environments. Analysis of FDA product recall data for 134 non-sterile pharmaceutical products from 1998 to September 2006 demonstrated that 48% of recalls were due to contamination by either Burkholderia cepacia, Pseudomonas spp., or Ralstonia picketti, while yeast and mold contamination were found in 23% of recalls. Gram-negative bacteria accounted for 60% of recalls, but only 4% were associated with Gram-positive bacteria. Of the 193 recalls of sterile products, 78% were due to the lack of sterility assurance and 7% for yeast and mold contamination. For sterile products, Gram-negative bacteria accounted for 6% of recalls, with only 1% due to Gram-positive bacteria. For non-sterile and sterile products, B. cepacia was the most frequently isolated microbial species with 22% and 2.5% of recalls, respectively. Based upon the review of the scientific literature, B. cepacia, Pseudomonas spp., or Ralstonia picketti may be associated with water contamination, while yeast and mold and Gram-positive bacteria may have indicated deficient environmental controls. The presence of unculturable microbial populations in pharmaceutical waters and clean rooms was reported, but no evidence has been published that product quality was negatively affected.

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.

Infection control in a hernia clinic: 24 year results of aseptic and antiseptic measure implementation in 4,620 "clean cases".

Post Mesh Herniorrhaphy Infection [PMHI] occurs between 3 to 4% of inguinal and 8 to 14% of ventral herniorrhaphies producing an unacceptably high morbidity. Before opening a Hernia Clinic, our infection rate was around 5% for "clean" inguinals and 8% for "clean" ventral herniorrhaphies. Starting in 1982 we implemented a stricter operative aseptic protocol plus the per-operative administration of 1 g of intravenous Cefazolin. In addition, wounds were irrigated with a solution containing 80 mgs of Gentamycin Sulphate dissolved in 250 ml of Normal Saline Solution. During a period of 25 years these measures were used in 4300 consecutive "clean "Inguinal and 320 "clean" Ventral herniorrhaphies. Since the implementation of the above-mentioned aseptic and antiseptic steps no further wound infections were encountered. In our hands, the combination of rigorous aseptic operating room routine plus intravenous and topical antibiotics have, up to now, effectively eliminated wound infections in "clean" herniorrhaphy cases.