Draft Guidelines Research Articles

Development of Fire Safety Guidelines (Draft) on Finishing Materials for Nuclear Power Plants

In general, finishing materials used in nuclear power plants and auxiliary buildings are designed in accordance with NRC documents, in terms of their design, construction, and fire safety. However, only a few finishing materials produced in Korea have been certified relative to their fire-retardant performance, based on fire laboratory testing in the USA. In this study, to establish fire safety guidelines on finishing materials, designed in Korea, for nuclear power plants, related building regulations have been compared with codes, fire testing has been performed in Korea and the USA on the same specimens, and the fire safety guidelines have been established for the finishing materials.

The works done by the UN International Law Commission during the 72nd session(2021) and the discussion done at the 6th Committee of the UN General Assembly(76th session, 2021)

Amid the Covid-19 pandemic, the 72nd session of the ILC was convened in Geneva in 2021 after a year-long suspension based on the UNGA Decision 74/566 (2020). During the 72nd session, the ILC concluded the second reading of two topics, namely “the Protection of the atmosphere” that consists of 12 draft guidelines together with commentaries and “Provisional application of treaties” comprising 12 draft guidelines and a draft annex, containing examples of provisions on provisional application of treaties, together with commentaries thereto. The ILC continued its deliberations on the other topics: the topic of “Immunity of State officials from foreign criminal jurisdiction”, the ILC adopted 6 draft articles on procedural aspects and safeguards. The ILC made also a progress on the topic of “Succession of States in relation to international law” and “General principles of law”. The ILC established a Study Group to deal with the topic of “Sea-level rise in relation to international law” that was included in the Commission’s programme in 2019. During the session, the Study Group focused on the subject of sea-level rise in relation to the law of the sea, based on the first issue paper. The Study Group next year will fous on issues related to statehood, as well as those related to the protection of persons affected by sea-level rise. The ILC decided to include the topic of “Subsidiary means for the determination of rules of international law” in its long-term programme of work. During the 72nd session, the ILC took two memorial meetings for two former ILC members: Judge Alexander Yankov and Judge James Crawford.

Draft of Russian Clinical Practice Guidelines «Male hypogonadism»

Hypogonadism in males, defined as a decrease in serum testosterone levels in combination with characteristic symptoms and/or signs, can be observed with pathological changes in the testicles and/or pituitary gland, such as Klinefelter’s syndrome, Kallman’s syndrome, as well as in men with metabolic (obesity, diabetes mellitus) or iatrogenic disorders leading to a decrease in androgen production. The draft guidelines cover the extensive range of pathologies that cause hypogonadism development (testosterone deficiency) and focus on its clinical variants, which make up the majority of cases of hypogonadism observed in men. The authors and reviewers are an interdisciplinary group of experts, consisting of endocrinologists, andrologists, urologists - members of the «Russian Association of Endocrinologists» and «Men’s and Reproductive Health» public organizations.Clinical guidelines contain the most reliable evidence available to experts at the time of writing. Nevertheless, recommendations cannot replace clinical experience, and deciding on the start of treatment, choosing a method of therapy, or a drug should always consider the individual characteristics of a specific patient.

Substantial health benefits of strengthening guidelines on indoor fine particulate matter in China.

In 2020, China for the first time developed guidelines for indoor fine particulate matter (PM2.5) in the draft document of indoor air standards, while the associated health implication remains unclear. Here, we first estimated the PM2.5 associated premature deaths was 965 thousand in 2019, with the indoor PM2.5 of outdoor origin accounting for 72.9%. Then, we examined the dynamic mortalities under a scenario matrix of 36 conditions, by incorporating various shared socioeconomic pathways in 2035, the draft guidelines and the contributions of ambient PM2.5 to indoor exposure. Although it may be improbable, the averages of premature deaths associated with ambient PM2.5 will be 1018-1361 thousand in 2035 when the worst-case scenario of guidelines mandating a yearly (rather than daily) indoor PM2.5 concentration of 75 µg/m3, compared to the averages of estimation were 816-1304 thousand for better-case scenario of 35 µg/m3. Under these scenarios, the increase in the number of premature deaths was mainly driven by population aging. In 2035, an ambitious target of yearly indoor PM2.5 concentrations of 15 µg/m3 is anticipated to reduce the number of deaths associated with ambient PM2.5 by approximately 25% of the 2019 baseline. Stricter guidelines to restrict the indoor PM2.5 concentrations are recommended to mitigate the mortality risk in the future.

Development of Identification Instruments for Children with Specific Learning Disability in Elementary School

This study aims to facilitate the identification of students in elementary school who have specific learning dissability. This study employs a qualitative approach to the literature review process. The study collected data from books and articles that discuss identifying specific learning dissability. The data collection technique is based on a literature review of scientific books and journals and interviews with professional practitioners and academics, subsequently validated. The findings of this study are presented in the form of a draft identification guide for elementary school-aged children with specific learning dissability. Teachers and parents can easily use the draft guidelines for identifying children with specific learning dissability because they are presented concisely and clearly that refers to the theory and validated by four validators, including psychologists, special education lecturers, and inclusive school and special education teachers. The identification guideline draft for children with specific learning dissability in elementary school-age includes procedures for identifying children with specific learning dissability in general and instruments for identifying children with dyslexia, dyscalculia, and dysgraphia. This procedure was proposed to assist teachers and parents in identifying children with specific learning dissability in elementary school.

Efficacy and Safety of Different Immunosuppressive Therapies in Patients With Membranous Nephropathy and High PLA2R Antibody Titer.

Background: This study aimed to evaluate clinical features and prognosis and therapy option of patients with different risk ranks based on antibody against the M-type phospholipase-A2-receptor (PLA2Rab) level in seropositive M-type phospholipase-A2-receptor (PLA2R)-associated membranous nephropathy (MN) in a large sample size, multi-center study. Method: Based on the unvalidated cut-off value of PLA2Rab above 150 RU/ml as one of the clinical criteria for high risk of progressive kidney function loss in MN according to 2020 Kidney Disease: Improving Global Outcomes (KDIGO) draft guidelines recommendation, a total of 447 patients who received cyclophosphamide (CTX) or tacrolimus (TAC) combined with corticosteroids treatment for 12 months were divided into high titer (>150 RU/ml) group and non-high titer (20–150 RU/ml) group, which were subdivided into CTX subgroup and TAC subgroup. The overall cohort was classified into CTX group and TAC group as well. Clinical parameters levels and remission rates were recorded at 3, 6, and 12 months follow-up. PLA2Rab was tested by enzyme-linked immunosorbent assay. Results: Patients with high titer PLA2Rab were associated with more severe proteinuria and hypoalbuminemia compared to those with non-high titer antibody, accompanied by lower complete remission (CR) and total remission (TR) rates at 3, 6, and 12 months, which even took longer to remission. Similar remission rates differences between the two titer groups were observed in the CTX and TAC groups, respectively. PLA2Rab level at baseline was an independent predictive factor for CR and TR. In the high titer group, CR and TR rates in the CTX subgroup were significantly higher than those in the TAC subgroup at 12 months, although serious adverse events were more frequent in the former. Conclusion: High-risk rank patients with PLA2Rab level above 150 RU/ml have higher disease activity and worse prognosis among patients with seropositive PLA2R-associated MN, even under different immunosuppressive therapeutic models; moreover, CTX combined with corticosteroids was preferred compared to TAC plus corticosteroids, although serious adverse events were more frequent in the former. Additionally, baseline PLA2Rab level was an independent predictive factor for clinical remission.

A validated and discriminatory in vitro release test for evaluation of marketed Clotrimazole cream formulations

In vitro surrogate tests are broadly used for evaluation of the critical release characteristics of semi-solid dosage forms. In general, these tests are limited to assess the effect of crucial manufacturing process related steps on the physicochemical characteristics and overall drug product performance. In vitro release tests (IVRT) do not directly anticipate in vivo performance, but may detect in vitro changes that may correlate with in vivo performance. The objective of this work was to develop a suitable in vitro release test for evaluation of the similarity between two marketed Clotrimazole 1% Cream formulations. A systematic approach was used to address some essential qualification parameters and validation concepts described in EMA`s draft guideline on quality and equivalence of topical products. The procedure included suitable evaluation of the receptor medium, membrane qualification, followed by evaluation of method precision and method robustness. For evaluation of data, the comparison of Clotrimazole release profile met the relevant acceptance criteria for the 90% Confidence Interval for the ratio of means of the pairwise comparisons falling inside the limits of 90–111%. The linearity of the IVRT method as function of the drug concentration in the formulation was evaluated with 50% and 200% API formulations. In addition, the discriminatory power of the method was confirmed with formulation with altered viscosity as critical quality attribute. After validation of the method, the Clotrimazole 1% cream formulations were compared and their similarity was assessed. The approach was found to be useful and comprehensive in performing validation activities. Key words: IVRT, Clotrimazole cream formulation, method validation, discriminatory power

Development of Guidelines for Spouses Engaged in Home-Based Care of Persons With Motor Neuron Disease From Indian Context.

Background: The caregivers of persons with motor neuron disease (MND) have several needs that are usually not voiced on any platform. Aim: To explore the lived experience of spouses of persons with MND, identify their needs and develop guidelines for better home-based care. Method: An exploratory study with 3-point in-depth interviews among 13 participants was conducted. Participants were the spouses of persons with MND under treatment at a national quaternary referral center. The interpretative phenomenological analysis identified participants’ needs. These needs, with literature review synthesis, guided the drafting of guidelines, which was validated by experts. Results: The needs were emotional, social, care systems, and skills. The guidelines developed contained 2 sections (1) Information for the spouses: understanding MND, communication, symptom management, marital relationship, palliative care, and everyday life made easier. (2) Well-being of the spouse caregivers: well-being of the spouse caregivers, self-care, mental health, supporting carers in palliative care, where to find help. Conclusion: The guidelines can be developed as a manual for the caregivers and for training healthcare professionals working with neurodegenerative conditions.

POSC424 Registry-Based Studies in Practice: Enhancing Real-World Evidence Generation in Rare Disease and Personalized Medicine

Objective : The European Medicines Agency (EMA) issued a draft guideline on registry-based studies (RBS) in September 2020. We present our experience designing observational RBS and integrating feed-back received from regulatory authorities.

육군 사단 건강증진사업 가이드라인 개발: ‘CLEAR Toolkit’을 기반으로

Purpose: The purpose of this study was to develop a health promotion project guideline for the workers in charge of the Army Division''s health promotion project. The study was based on the CLEAR Toolkit’s four steps named as ‘Treat, Ask, Refer, Advocate’. Methods: This methodological study was performed by two phase. First, focus group interview of fifteen workers in charge of the Army Division''s health promotion project was carried out to make-up a guideline draft. Second, a validity test was done by five experts of military health promotion project, then the authors finalized the guideline based on their opinions. Results: The guideline was consisted of 11 theme clusters and four clusters called ‘Check the health problems’, ‘Ask about health promotion needs’, ‘Refer to in and out of military system’, ‘Advocate for consistent health promotion activities’. Conclusion: So, this guideline will be used to more effectively improve the health statues of army soldiers when offering health promotion project.

Indian Academy of Pediatrics Revised (2021) Guidelines on Prevention and Treatment of Vitamin D Deficiency and Rickets

The emerging literature on prevalence of vitamin D deficiency in India, prevention and treatment strategies of rickets, and extra-skeletal benefits of vitamin D suggest the need for revising the existing guidelines for prevention and treatment of vitamin D deficiency in India. To review the emerging literature on vitamin D prevalence and need for universal vitamin D supplementation. To suggest optimum vitamin D therapy for treatment of asymptomatic and symptomatic vitamin D deficiency, and rickets. To evaluate the extra-skeletal health benefits of vitamin D in children. A National consultative committee was formed that comprised of clinicians, epidemiologists, endocrinologists, and nutritionists. The Committee conducted deliberations on different aspects of vitamin D deficiency and rickets through ten online meetings between March and September, 2021. A draft guideline was formulated, which was reviewed and approved by all Committee members. The group reiterates the serum 25-hydroxy vitamin D cutoffs proposed for vitamin D deficiency, insufficiency, and sufficiency as <12 ng/mL, 12-20 ng/mL and >20 ng/mL, respectively. Vitamin D toxicity is defined as serum 25OHD >100 ng/mL with hypercalcemia and/or hypercalciuria. Vitamin D supplementation in doses of 400 IU/day is recommended during infancy; however, the estimated average requirement in older children and adolescents (400-600 IU/day, respectively) should be met from diet and natural sources like sunlight. Rickets and vitamin D deficiency should be treated with oral cholecalciferol, preferably in a daily dosing schedule (2000 IU below 1 year of age and 3000 IU in older children) for 12 weeks. If compliance to daily dosing cannot be ensured, intermittent regimens may be prescribed for children above 6 months of age. Universal vitamin D supplementation is not recommended in childhood pneumonia, diarrhea, tuberculosis, HIV and non-infectious conditions like asthma, atopic dermatitis, and developmental disorders. Serum 25-hydroxy vitamin D level of >20 ng/mL should be maintained in children with conditions at high-risk for vitamin deficiency, like nephrotic syndrome, chronic liver disease, chronic renal failure, and intake of anticonvulsants or glucocorticoids.

Evaluation of the quality of state programs: the outcomes of testing of a multi-criteria model (results, problems, opportunities)

Decree of the President of the Russian Federation № 633 dated November 8, 2021 «On approval of the Fundamentals of State Policy in the field of strategic planning in the Russian Federation» among the main directions of state policy in this area, scientific and methodological support for strategic planning of socio-economic development and ensuring national security is defined [3]. Within the framework of this direction, a multi-criteria model for assessing the quality of state programs of the Russian Federation has been developed and passed initial testing. New methodological approaches have been transformed into an algorithm and assessment tools, brought to the level of draft Guidelines and tested on the example of several government programs of various formats and areas of implementation. The model includes the author's conceptual apparatus, parameters and evaluation criteria, a regulated sequence of evaluation procedures (algorithm), specific tools, a specially developed tabular format for obtaining and issuing evaluation results. The principal features of the multicriteria model were described earlier [11]. This article presents the first practical results of assessing the quality of individual state programs of the Russian Federation based on the developed model. The obtained results, in turn, can be used for further improvement of the model.

Pilot Equivalence Study Comparing Different Batches of Topical 0.025% Capsaicin Emulsion: Product Microstructure, Release, and Permeation Evaluation.

The European Medical Agency (EMA) has issued a draft guideline on the quality and equivalence of topical products. The equivalence for complex semisolid formulations involves several steps: the same quantitative content, the same microstructure, the same release, and permeation profile. In this paper, several batches of a low strength topical product, which we used as a reference/comparator product, were evaluated according to the recommendations of the EMA draft guideline. The batches were 0.025% capsaicin emulsions from the same manufacturer that were evaluated in terms of droplet size, X-ray diffraction patterns, rheology, release, and permeation profile. The generated data revealed a large batch-to-batch variability, and if the EMA guideline was applied, these batches would not be considered equivalent, although they were produced by the same manufacturer. The result of this work illustrates the difficulties in obtaining equivalence according to the current draft guidelines. It also highlights that the equivalence guidelines should consider the variability of the comparator product, and in our opinion, the guidelines should allow for claiming equivalence by comparing the limits in the variability of the data generated for the comparator product with the limits in the variability of the data generated for the intended equivalence product.

1. International Transfer of Restricted or Prohibited Substances

The number of parties to the Basel Convention has been gradually increasing over the years. This year, one new state—Tuvalu—joined the Basel Convention, bringing its number of parties to 188. The Amendments to Annexes II, VIII, and IX to the Basel Convention entered into force on 24 March. In the case of the Basel Protocol on Liability and Compensation for Damage Resulting from Transboundary Movements of Hazardous Wastes and Their Disposal, its number of parties remains at twelve, which means that the protocol has not yet entered into force. Sierra Leone ratified the 1995 Amendment to the Basel Convention, bringing its number of parties to ninety-nine (see Status of Ratifications <http://www.basel.int/Countries/StatusofRatifications/tabid/1341/Default.aspx>). The twelfth meeting of the Open-Ended Working Group (OEWG-12) was postponed and held according to two components, consisting of an online segment and a face-to-face segment, due to the global COVID-19 pandemic. The online segment was held on 1–3 September. Representatives of 120 countries took part in the virtual meeting of the OEWG-12. A total of more than six hundred people attended the meeting, including representatives of state parties and observers. Various technical, policy, and legal documents were briefly reviewed, including draft reports, guidelines, technical guidelines, and recommendations. Final versions of these documents will be considered at the face-to-face segment of the OEWG-12 in 2022 and at the fifteenth Conference of the Parties (COP-15) to the Basel Convention, scheduled to be held in July 2021.

Changes in Prostate-Specific Antigen Testing Relative to the Revised US Preventive Services Task Force Recommendation on Prostate Cancer Screening

In April 2017, the US Preventive Services Task Force (USPSTF) published a draft guideline that reversed its 2012 guidance advising against prostate-specific antigen (PSA)-based screening for prostate cancer in all men (grade D), instead endorsing individual decision-making for men aged 55 to 69 years (grade C). To evaluate changes in rates of PSA testing after revisions in the USPSTF guideline on prostate cancer screening. This retrospective cohort study used deidentified claims data from Blue Cross Blue Shield beneficiaries aged 40 to 89 years from January 1, 2013, through December 31, 2019. Publication of the USPSTF's draft (April 2017) and final (May 2018) recommendation on prostate cancer screening. Age-adjusted rates of PSA testing in bimonthly periods were calculated, and PSA testing rates from calendar years before (January 1 to December 31, 2016) and after (January 1 to December 31, 2019) the guideline change were compared. Interrupted time series analyses were used to evaluate the association of the draft (April 2017) and published (May 2018) USPSTF guideline with rates of PSA testing. Changes in rates of PSA testing were further evaluated among beneficiaries within the age categories reflected in the guideline: 40 to 54 years, 55 to 69 years, and 70 to 89 years. The median number of eligible beneficiaries for each bimonthly period was 8 087 565 (range, 6 407 602-8 747 308), and the median age of all included eligible beneficiaries was 53 years (IQR, 47-59 years). Between 2016 and 2019, the mean (SD) rate of PSA testing increased from 32.5 (1.1) to 36.5 (1.1) tests per 100 person-years, a relative increase of 12.5% (95% CI, 1.1%-24.4%). During the same period, mean (SD) rates of PSA testing increased from 20.6 (0.8) to 22.7 (0.9) tests per 100 person-years among men aged 40 to 54 years (relative increase, 10.1%; 95% CI, -2.8% to 23.7%), from 49.8 (1.9) to 55.8 (1.8) tests per 100 person-years among men aged 55 to 69 years (relative increase, 12.1%; 95% CI, -0.2% to 25.2%), and from 38.0 (1.4) to 44.2 (1.4) tests per 100 person-years among men aged 70 to 89 years (relative increase, 16.2%; 95% CI, 4.2%-29.0%). Interrupted time series analysis revealed a significantly increasing trend of PSA testing after April 2017 among all beneficiaries (0.30 tests per 100 person-years for each bimonthly period; P < .001). This large national cohort study found that rates of PSA testing increased after the USPSTF's draft statement in 2017, reversing trends seen after earlier guidance against PSA testing for all patients. Increased testing was also observed among older men, who may be less likely to benefit from prostate cancer screening.

European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults

ScopeIn 2009, the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) published the first treatment guidance document for Clostridioides difficile infection (CDI). This document was updated in 2014. The growing literature on CDI antimicrobial treatment and novel treatment approaches, such as faecal microbiota transplantation (FMT) and toxin-binding monoclonal antibodies, prompted the ESCMID study group on C. difficile (ESGCD) to update the 2014 treatment guidance document for CDI in adults. Methods and questionsKey questions on CDI treatment were formulated by the guideline committee and included: What is the best treatment for initial, severe, severe-complicated, refractory, recurrent and multiple recurrent CDI? What is the best treatment when no oral therapy is possible? Can prognostic factors identify patients at risk for severe and recurrent CDI and is there a place for CDI prophylaxis? Outcome measures for treatment strategy were: clinical cure, recurrence and sustained cure. For studies on surgical interventions and severe-complicated CDI the outcome was mortality. Appraisal of available literature and drafting of recommendations was performed by the guideline drafting group. The total body of evidence for the recommendations on CDI treatment consists of the literature described in the previous guidelines, supplemented with a systematic literature search on randomized clinical trials and observational studies from 2012 and onwards. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) system was used to grade the strength of our recommendations and the quality of the evidence. The guideline committee was invited to comment on the recommendations. The guideline draft was sent to external experts and a patients' representative for review. Full ESCMID endorsement was obtained after a public consultation procedure. RecommendationsImportant changes compared with previous guideline include but are not limited to: metronidazole is no longer recommended for treatment of CDI when fidaxomicin or vancomycin are available, fidaxomicin is the preferred agent for treatment of initial CDI and the first recurrence of CDI when available and feasible, FMT or bezlotoxumab in addition to standard of care antibiotics (SoC) are preferred for treatment of a second or further recurrence of CDI, bezlotoxumab in addition to SoC is recommended for the first recurrence of CDI when fidaxomicin was used to manage the initial CDI episode, and bezlotoxumab is considered as an ancillary treatment to vancomycin for a CDI episode with high risk of recurrence when fidaxomicin is not available. Contrary to the previous guideline, in the current guideline emphasis is placed on risk for recurrence as a factor that determines treatment strategy for the individual patient, rather than the disease severity.

Letter to the article “Sepsis in children: federal clinical guidelines (draft)”

In the letter, the author relies on data from the foreign and domestic literature and his own experience and confirms the relevant creation of clinical guidelines, Sepsis in children. The letter summarizes the main advantages of domestic recommendations and notes the provisions requiring critical assessment. In general, the author of the letter highly appreciated the work done by the authors of the recommendation.

Reply to the Commentary on the article “Sepsis in children: federal guidelines (draft)” I.А. Savin

The authors of the Clinical Guidelines are grateful to Professor I.A. Savin for his comments and provide answers to the comments made regarding the appointment of antibacterial drugs and immunoglobulins for sepsis in children.

1262 Audit of MRI IAM (Internal Auditory Meatus) Requests at Darlington Memorial Hospital and Review of The Literature

Abstract Aim To assess if the MRI IAM scans are being requested as suggested in NICE guidelines Draft 2017 for consultations. Educate and implement any changes if needed to minimise unnecessary investigations. Method Retrospective data collection of 1000 data. Variables included hearing loss (HL), tinnitus (T), dizziness (D) and other lateralized symptoms. Audiograms assessed for asymmetrical HL at decibel level ≥20 Db at a frequency of 0.5 kHz, 1.0 kHz, 2.0 kHz. MRI of IAM assessed if a cerebellar pontine angle (CPA) lesion was presented. Results 853 (85.3%) met criteria. 16/1000 (1.6%) MRI showed CPA lesion. All 16 cases had unilateral sensorineural hearing loss (SNHL) and met NICE guidelines criteria. Discussion Limited value in the scanning of asymptomatic patients, those who do not fit audiometric guidelines, those bilateral symptoms or those with unilateral tinnitus without audiometric asymmetry. Very few studies were found in the literature in relation to symptoms associated with positive findings of CPA lesion. Our results indicate unilateral SNHL were linked with positive findings of MRI and it is similar findings in the literature. We recommend that patients who present with asymmetrical SNHL with this audiometric asymmetrical characteristic of 20Db or more will need an urgent MRI IAM as part of their diagnostic workup.

Biological Risk in Italian Prisons: From the COVID-19 Management to the Development of a Standardized Model for Emergency Response.

Within the confinements of critical infrastructures, the COVID-19 pandemic is posing a series of challenges to Health Management. In the spotlight of highly contagious and quick spreading diseases within such enclosed facilities, whether it be a detention facility or otherwise, the health and safety of those living within its internment is paramount. This paper aims to highlight the specific challenges and the possible solutions to counteract this problem, starting from the lessons learnt from the Italian prison system case study. Following the general description of the available resources within the Italian prisons, the study aimed at specifically describing the first counteracting measures deployed by the Italian prison authorities during the first phase of the COVID-19 outbreak (February–July 2020). The aim was to propose an integrated plan capable of responding to a biological threat within the prisons. In particular, the study describes the actions and technical features that, in accordance with national and international legal frameworks and the relevant organisational bodies that run the Italian Prison Service, had been adopted in managing, right from the start, the COVID-19 pandemic until Summer 2020. Available information and data showed the ability of the prison administration to comply almost completely with WHO’s technical and human rights recommendations and also, in successfully handling prison emergencies both in terms of the sick and the deceased in line with the epidemiological framework of the general population. In addition, the paper proposes a draft of guidelines that should involve the National Health Service and the Prison Service that are aimed at supporting the local prison facilities with drawing up their own biological incident contingency plans. An approved, legal, standardised plan could increase the awareness of prison managers. It could even increase their self-confidence, in particular, with regard to cases of dispute and their ability to respond to them. In fact, it is valuable and forward-thinking to be able to demonstrate that every endeavour has been taken and that ‘certified’ best practices have been put in place in accordance with the national standards.