The impact of ageing on adults with cerebral palsy: the results of a national online survey.

BACKGROUND: Cerebral palsy (CP) is one of the most common neurological disorders in children and results in lifelong physical impairments. Adults with CP have approximately the same life expectancy as their non-disabled peers, so helping them to stay healthy throughout the life course will have long-term cost benefits via reductions in hospital admissions, long-term care, and unemployment rates. AIM: To explore how adults with CP experience ageing. DESIGN & SETTING: National online survey given to adults with CP in the UK. METHOD: The participants were adults with CP. Items for the online survey were taken from existing self-report measures, with additional items developed for the survey. Several domains of functioning were assessed including mobility, dexterity, fatigue, pain, speech, mental health, swallowing and health maintenance/self-care as well as healthcare usage. Data were analysed using χ2 to examine the relationships between the demographic variables and the survey responses. RESULTS: The survey was completed by 395 participants, of whom 74.2% were female and approximately 59.3% aged <45 years. Responders reported having problems with mobility, pain, and fatigue with older participants reporting higher levels of pain and more mobility problems, although the correlations were fairly small. Healthcare usage was surprisingly low. CONCLUSION: The study found that age was associated with a decline in mobility and a higher level of pain, although the relationships were weak. It is possible that the low healthcare usage among the responders is owing to services not being available to respond to their needs.

Evaluating the UK's first national prescribing assessment for GPs in training using an online survey.

BACKGROUND: GP trainees may not have experienced a systematic and comprehensive education in safe prescribing. Therefore, a self-assessment prescribing review was developed. AIM: To determine whether the assessment was feasible, had face validity, and did not disadvantage particular groups of participants. DESIGN & SETTING: An online survey that evaluates the opinions of GPs in training of a prescribing assessment in the UK. All full-time UK trainees who started their final year of GP training in August 2019 undertook the prescribing assessment along with their trainers, after which they completed an online anonymous feedback questionnaire. METHOD: The questionnaire completed by trainees sought their opinions of the assessment, and collected ethnicity and disability data. The trainer questionnaire was similar but did not include any demographic information. RESULTS: The questionnaire was completed by 1741 trainees and 1576 trainers. There was no evidence that ethnic group and disability were related to aspects of the review. Most of the trainees (76.4%, n = 1330) and trainers (82.0%, n = 1293) agreed or strongly agreed that the prescribing review was helpful for assessing and learning about the trainee's prescribing. However, most participants (63.2%, n = 1092) took >4 hours to review their prescriptions. A majority of trainees (90.2%, n = 1571) reported that completing the assessment had resulted in a change in their prescribing practice. CONCLUSION: The majority of trainers and trainees reported that the prescribing assessment was helpful. The study was not able to assess whether there had been an actual change in practice that resulted in an error reduction.

Retrospective review of medication-related incidents at a major teaching hospital and the potential mitigation of these incidents with electronic prescribing and medicines administration.

OBJECTIVES: To describe the frequency of the different types of medication-related incidents that caused patient harm, or adverse consequences, in a major teaching hospital and investigate whether the likelihood of these incidents occurring would have been reduced by electronic prescribing and medicines administration (EPMA). METHODS: A retrospective review of harmful incidents (n=387) was completed for medication-related reports at the hospital between 1 September 2020 and 31 August 2021. Frequencies of different types of incidents were collated. The potential for EPMA to have prevented these incidents was assessed by reviewing DATIX reports and additional information, including results of any investigations. RESULTS: The largest proportion of harmful medication incidents were administration related (n=215, 55.6%), followed by incidents classified as 'other' and 'prescribing'. Most incidents were classified as low harm (n=321, 83.0%). EPMA could have reduced the likelihood of all incidents which caused harm by 18.6% (n=72) without configuration, and a further 7.5% (n=29) with configuration where configuration refers to adapting the software's functionality without supplier input or development. For 18.4% of the low-harm incidents (n=59) and 20.3% (n=13) of the moderate-harm incidents, EPMA could reduce the likelihood of the incident occurring without configuration. Medication errors most likely to be reduced by EPMA were due to illegibility, multiple drug charts or missing drug charts. CONCLUSION: This study found that administration incidents were the most common type of medication-related incidents. Most of the incidents (n=243, 62.8%) could not be mitigated by EPMA in any circumstance, even with connectivity between technologies. EPMA has the potential to prevent certain types of harmful medication-related incidents, and further improvements could be achieved with configuration and development.

Early COVID-19 respiratory risk stratification using machine learning.

Background: COVID-19 has strained healthcare systems globally. In this and future pandemics, providers with limited critical care experience must distinguish between moderately ill patients and those who will require aggressive care, particularly endotracheal intubation. We sought to develop a machine learning-informed Early COVID-19 Respiratory Risk Stratification (ECoRRS) score to assist in triage, by providing a prediction of intubation within the next 48 hours based on objective clinical parameters. Methods: Electronic health record data from 3447 COVID-19 hospitalizations, 20.7% including intubation, were extracted. 80% of these records were used as the derivation cohort. The validation cohort consisted of 20% of the total 3447 records. Multiple randomizations of the training and testing split were used to calculate confidence intervals. Data were binned into 4-hour blocks and labeled as cases of intubation or no intubation within the specified time frame. A LASSO (least absolute shrinkage and selection operator) regression model was tuned for sensitivity and sparsity. Results: Six highly predictive parameters were identified, the most significant being fraction of inspired oxygen. The model achieved an area under the receiver operating characteristic curve of 0.789 (95% CI 0.785 to 0.812). At 90% sensitivity, the negative predictive value was 0.997. Discussion: The ECoRRS score enables non-specialists to identify patients with COVID-19 at risk of intubation within 48 hours with minimal undertriage and enables health systems to forecast new COVID-19 ventilator needs up to 48 hours in advance. Level of evidence: IV.

The frequency and nature of prescribing problems by GPs-in-training (REVISiT): a retrospective review.

BACKGROUND: Prescribing errors can cause significant morbidity and occur in about 5% of prescriptions in English general practices. AIM: To describe the frequency and nature of prescribing problems in a cohort of GPs-in-training to determine whether they need additional prescribing support. DESIGN & SETTING: A primary care pharmacist undertook a retrospective review of prescriptions issued between 9 October 2014 and 11 March 2015 by 10 GPs in their final year of training from 10 practices in England. METHOD: Pre-existing standards and expert panel discussion were used to classify the appropriateness of prescribing. Data were imported into Stata (version 13) to perform descriptive analysis. An individualised report highlighting prescribing errors, suboptimal prescribing, and areas of good practice identified during the review was shared with the GPs-in-training and their trainers. This report was used to guide discussions during the GP-in-training's feedback session. RESULTS: A total of 1028 prescription items were reviewed from 643 consultations performed by 10 GPs-in-training. There were 92 prescribing errors (8.9%) and 360 episodes of suboptimal prescribing (35.0%). The most common types of error concerned medication dosages (n = 30, 32.6% of errors). CONCLUSION: Personalised review of prescribing revealed an error rate higher than recorded in a previous similar study mainly comprising GPs who had completed postgraduate training, and a substantially higher rate of suboptimal prescribing. A larger intervention study is now required to evaluate the effectiveness of receiving a personalised review of prescribing, and to assess its impact on patient safety.

Income dynamics in the United Kingdom and the impact of the Covid-19 recession.

In this paper, we use an employer-based survey of earnings and hours to set out the key patterns in UK earnings dynamics from 1975 to 2020, with a particular focus on the most recent recession. We demonstrate that (log) earnings changes exhibit strongly procyclical skewness and have become increasingly leptokurtic, and thus less well approximated by a log-normal distribution, over the period of study. This holds across genders and sectors. Exploiting the long duration of our panel, we then explore the responsiveness of earnings and hours to aggregate and firm-level shocks, finding ample heterogeneity in the exposure of different types of workers to aggregate shocks. Exposure is falling in age, firm size, skill level, and permanent earnings, and is lower for unionized and public sector workers. The qualitative patterns of earnings changes across workers observed in the Covid-19 recession of 2020 are broadly as predicted using the previously estimated exposures and size of the shock. Firm-specific shocks are important for wages given the variation in within-firm productivity and the patterns of heterogeneity are markedly different than for aggregate shocks.

Anticholinergic drugs and risk of dementia: Time for action?

Evidence suggests that the prescription of bladder anticholinergics is increasing. Recent studies have accentuated concerns about whether certain prescribed medications could increase risk of dementia, including anticholinergic drugs, and specifically anticholinergics used for bladder symptoms. Nevertheless, it can be difficult to draw together the evidence to review the case for possible causation. Recognising this issue in 1965, Bradford-Hill set out nine criteria to help assess whether evidence of a causal relationship could be inferred between a presumed cause and an observed effect. In this commentary, we explore the extent to which associations between anticholinergics and dementia satisfy the Bradford-Hill criteria and examine the potential implications. First, we look at studies that have examined the relationship between anticholinergic drugs with urological properties (bladder drugs) and the onset of dementia, and then present those studies which specifically focus on the cognitive effects of bladder drugs that affect muscarinic receptors in the brain versus the bladder on older people along with suggestions for future research. We also discuss the risks and benefits of these drugs for treating overactive bladder. If it can be shown that certain medications carry a specific risk of dementia, it is possible that initiatives to change prescribing could become a key tool in reducing the risk of dementia and may be easier to implement than some lifestyle changes.

The evaluation of an e-learning prescribing course for general practice.

Prescribed medication may lead to significant morbidity or mortality as a result of these medications causing adverse events, or because of a prescribing error. E-learning is a common tool used in supporting training in prescribing. This paper describes the development of an e-learning course and the subsequent evaluation undertaken by the users with the aim of obtaining an effective e-learning course for prescribing. The e-learning course was developed by general practitioners and pharmacists and focussed on the principles of good prescribing, examined the common reasons for prescribing errors, and was evaluated using self-reported quantitative and qualitative measures. Scores significantly increased on an assessment given before and after the course. The majority of respondents reported that the e-learning course had a positive impact on prescribing knowledge, skills and attitudes, with medication reviews the top area where a change in prescribing practice was reported. Over 90% of the respondents agreed that the e-learning course was easy to use and a useful part of their continuing professional education. This study shows that clinicians recognise the on-going need for training in prescribing, but the lack of training is one of the factors contributing to errors, which suggests that more education is needed, not just for GPs in training, but for qualified GPs as well.

Incidence, nature and causes of avoidable significant harm in primary care in England: retrospective case note review.

OBJECTIVE: To estimate the incidence of avoidable significant harm in primary care in England; describe and classify the associated patient safety incidents and generate suggestions to mitigate risks of ameliorable factors contributing to the incidents. DESIGN: Retrospective case note review. Patients with significant health problems were identified and clinical judgements were made on avoidability and severity of harm. Factors contributing to avoidable harm were identified and recorded. SETTING: Primary care. PARTICIPANTS: Thirteen general practitioners (GPs) undertook a retrospective case note review of a sample of 14 407 primary care patients registered with 12 randomly selected general practices from three regions in England (total list size: 92 255 patients). MAIN OUTCOME MEASURES: The incidence of significant harm considered at least 'probably avoidable' and the nature of the safety incidents. RESULTS: The rate of significant harm considered at least probably avoidable was 35.6 (95% CI 23.3 to 48.0) per 100 000 patient-years (57.9, 95% CI 42.2 to 73.7, per 100 000 based on a sensitivity analysis). Overall, 74 cases of avoidable harm were detected, involving 72 patients. Three types of incident accounted for more than 90% of the problems: problems with diagnosis accounted for 45/74 (60.8%) primary incidents, followed by medication-related problems (n=19, 25.7%) and delayed referrals (n=8, 10.8%). In 59 (79.7%) cases, the significant harm could have been identified sooner (n=48) or prevented (n=11) if the GP had taken actions aligned with evidence-based guidelines. CONCLUSION: There is likely to be a substantial burden of avoidable significant harm attributable to primary care in England with diagnostic error accounting for most harms. Based on the contributory factors we found, improvements could be made through more effective implementation of existing information technology, enhanced team coordination and communication, and greater personal and informational continuity of care.

Development of the prototype concise safe systems checklist tool for general practice.

BACKGROUND: In the course of producing a patient safety toolkit for primary care, we identified the need for a concise safe-systems checklist designed to address areas of patient safety which are under-represented in mandatory requirements and existing tools. This paper describes the development of a prototype checklist designed to be used in busy general practice environments to provide an overview of key patient safety related processes and prompt practice wide-discussion. METHODS: An extensive narrative review and a survey of world-wide general practice organisations were used to identify existing primary care patient safety issues and tools. A RAND panel of international experts rated the results, summarising the findings for importance and relevance. The checklist was created to include areas that are not part of established patient safety tools or mandatory and legal requirements. Four main themes were identified: information flow, practice safety information, prescribing, and use of IT systems from which a 13 item checklist was trialled in 16 practices resulting in a nine item prototype checklist, which was tested in eight practices. Qualitative data on the utility and usability of the prototype was collected through a series of semi-structured interviews. RESULTS: In testing the prototype four of nine items on the checklist were achieved by all eight practices. Three items were achieved by seven of eight practices and two items by six of eight practices. Participants welcomed the brevity and ease of use of the prototype, that it might be used within time scales at their discretion and its ability to engage a range of practice staff in relevant discussions on the safety of existing processes. The items relating to prescribing safety were considered particularly useful. CONCLUSIONS: As a result of this work the concise patient safety checklist tool, specifically designed for general practice, has now been made available as part of an online Patient Safety Toolkit hosted by the Royal College of General Practitioners. Senior practice staff such as practice managers and GP partners should find it a useful tool to understand the safety of less explored yet important safety processes within the practice.

A qualitative evaluation of a prescribing e-learning package for general practice.

BACKGROUND: The GMC PRACtiCe study identified a 1 in 20 error rate in prescriptions issued in general practice and identified a need for further training in prescribing. As a result, an e-Learning prescribing package was designed and launched to healthcare professionals through the Royal College of General Practitioners in January 2014. AIM: This part of the study explored the longer-term impact on prescribing knowledge, attitudes and behaviours of practitioners completing the eLearning prescribing package. METHOD: On completion of the e-Learning package, participants were asked to indicate their willingness to be contacted for a telephone interview. Semi-structured interviews were conducted which were audio recorded, transcribed verbatim and analysed using thematic analysis, aided by NVivo. Interviewees were invited to enter a prize draw to win Stockley's Drug Interaction textbook (provided courtesy of the Royal Pharmaceutical Society). RESULTS: Of the 120 participants who expressed an interest in being followed up for interview, seven prescribers were interviewed in 2014 and 2015. Reasons for completing the course were explored, and interviewees gave examples of changes made to their prescribing practice as a result of completing the e-Learning. This included the adoption of specific strategies to enhance safe practice, and enacting enhanced vigilance in key areas such as renal function monitoring. Some changes to the course content and presentation were also recommended. CONCLUSION: These interviews have highlighted the potential for using e-Learning for prescribing training and to achieve long-term changes in prescribing practice. However, further work is needed to generate substantive evidence of its impact on prescribing.

[Artificial intelligence in Danish healthcare].

Artificial intelligence (AI) and machine learning have become important in medicine as shown in this review. Automatic tools can be trained to analyse patient data and thereby be a great asset to doctors when diagnosing and treating patients. Denmark is a leading country in collecting data. Having large amounts of stored data improves the quality when building a prediction tool. Due to the potential of building AI in the Danish healthcare sector, a significant amount of money has been allocated to foster new innovations in the field. Denmark could play a critical rule utilising data and implementing AI in medicine.

A Patient Safety Toolkit for Family Practices.

OBJECTIVE: Major gaps remain in our understanding of primary care patient safety. We describe a toolkit for measuring patient safety in family practices. METHODS: Six tools were used in 46 practices. These tools were as follows: National Health Service Education for Scotland Trigger Tool, National Health Service Education for Scotland Medicines Reconciliation Tool, Primary Care Safequest, Prescribing Safety Indicators, Patient Reported Experiences and Outcomes of Safety in Primary Care, and Concise Safe Systems Checklist. RESULTS: Primary Care Safequest showed that most practices had a well-developed safety climate. However, the trigger tool revealed that a quarter of events identified were associated with moderate or substantial harm, with a third originating in primary care and avoidable. Although medicines reconciliation was undertaken within 2 days in more than 70% of cases, necessary discussions with a patient/carer did not always occur. The prescribing safety indicators identified 1435 instances of potentially hazardous prescribing or lack of recommended monitoring (from 92,649 patients). The Concise Safe Systems Checklist found that 25% of staff thought that their practice provided inadequate follow-up for vulnerable patients discharged from hospital and inadequate monitoring of noncollection of prescriptions. Most patients had a positive perception of the safety of their practice although 45% identified at least one safety problem in the past year. CONCLUSIONS: Patient safety is complex and multidimensional. The Patient Safety Toolkit is easy to use and hosted on a single platform with a collection of tools generating practical and actionable information. It enables family practices to identify safety deficits that they can review and change procedures to improve their patient safety across a key sets of patient safety issues.

Quantification of Perinodular Emphysema in High-risk Patients Offers No Benefit in Lung Nodule Risk-Stratification of Malignancy Potential.

PURPOSE: Pulmonary nodules, found either incidentally or on lung cancer screening, are common. Evaluating the benign or malignant nature of these nodules is costly in terms of patient risk and expense. The presence of both global and regional emphysema has been linked to increased lung cancer risk. We sought to determine whether the measurement of emphysema directly adjacent to a lung nodule could inform the likelihood of a nodule being malignant. MATERIALS AND METHODS: Within a population of Veterans at high risk for lung cancer, 58 subjects with malignant nodules found on computerized tomographic chest scans were matched by lobe and nodule size to 58 controls. Lung densitometry was measured via determination of the low attenuation area percentage at -950 Hounsfield units (LAA950) and the Hounsfield unit (HU) value at which 15% of lung voxels have a lower lung density (Perc15), at predefined lung volumes that encompassed the nodule to evaluate both perinodular and regional lung fields. The association between measured lung density and malignancy was investigated using conditional logistic regression models, with densitometry measurements used as the primary predictor, adjusting for age alone, or age and computerized tomographic scan characteristics. RESULTS: No significant differences in emphysema measurements between malignant and benign nodules were identified at lung volumes encompassing both perinodular and regional emphysema. Furthermore, emphysema quantification remained stable across lung volumes within individuals. CONCLUSIONS: In this study, quantifying the degree of perinodular or regional emphysema did not offer any benefit in the risk stratification of lung nodules.

A comparison of 6 osteoporosis risk assessment tools among postmenopausal women in Kuala Lumpur, Malaysia.

OBJECTIVES: To compare and assess the performance of 6 osteoporosis risk assessment tools for screening osteoporosis in Malaysian postmenopausal women. METHODS: Six osteoporosis risk assessments tools (the Simple Calculated Osteoporosis Risk Estimation [SCORE], the Osteoporosis Risk Assessment Instrument, the Age Bulk One or Never Estrogen, the body weight, the Malaysian Osteoporosis Screening Tool, and the Osteoporosis Self-Assessment Tool for Asians) were used to screen postmenopausal women who had not been previously diagnosed with osteoporosis/osteopenia. These women also underwent a dual-energy X-ray absorptiometry (DXA) scan to confirm the absence or presence of osteoporosis. RESULTS: A total of 164/224 participants were recruited (response rate, 73.2%), of which only 150/164 (91.5%) completed their DXA scan. Sixteen participants (10.7%) were found to have osteoporosis, whilst 65/150 (43.3%) were found to have osteopenia. Using precision-recall curves, the recall of the tools ranged from 0.50 to 1.00, whilst precision ranged from 0.04 to 0.14. The area under the curve (AUC) ranged from 0.027 to 0.161. The SCORE had the best balance between recall (1.00), precision (0.04-0.12), and AUC (0.072-0.161). CONCLUSIONS: We found that the SCORE had the best balance between recall, precision, and AUC among the 6 screening tools that were compared among Malaysian postmenopausal women.

Identifying 'avoidable harm' in family practice: a RAND/UCLA Appropriateness Method consensus study.

BACKGROUND: Health care-related harm is an internationally recognized threat to public health. The United Kingdom's national health services demonstrate that upwards of 90% of health care encounters can be delivered in ambulatory settings. Other countries are transitioning to more family practice-based health care systems, and efforts to understand avoidable harm in these settings is needed. METHODS: We developed 100 scenarios reflecting a range of diseases and informed by the World Health Organization definition of 'significant harm'. Scenarios included different types of patient safety incidents occurring by commission and omission, demonstrated variation in timeliness of intervention, and conditions where evidence-based guidelines are available or absent. We conducted a two-round RAND / UCLA Appropriateness Method consensus study with a panel of family practitioners in England to define "avoidable harm" within family practice. Panelists rated their perceptions of avoidability for each scenario. We ran a k-means cluster analysis of avoidability ratings. RESULTS: Panelists reached consensus for 95 out of 100 scenarios. The panel agreed avoidable harm occurs when a patient safety incident could have been probably, or totally, avoided by the timely intervention of a health care professional in family practice (e.g. investigations, treatment) and / or an administrative process (e.g. referrals, alerts in electronic health records, procedures for following up results) in accordance with accepted evidence-based practice and clinical governance. Fifty-four scenarios were deemed avoidable, whilst 31 scenarios were rated unavoidable and reflected outcomes deemed inevitable regardless of family practice intervention. Scenarios with low avoidability ratings (1 s or 2 s) were not represented by the categories that were used to generate scenarios, whereas scenarios with high avoidability ratings (7 s 8 s or 9 s) were represented by these a priori categories. DISCUSSION: The findings from this RAND/UCLA Appropriateness Method study define the characteristics and conditions that can be used to standardize measurement of outcomes for primary care patient safety. CONCLUSION: We have developed a definition of avoidable harm that has potential for researchers and practitioners to apply across primary care settings, and bolster international efforts to design interventions to target avoidable patient safety incidents that cause the most significant harm to patients.

Analyzing theory of mind impairment in patients with behavioral variant frontotemporal dementia.

OBJECTIVE: Behavioral variant frontotemporal dementia (bvFTD) and theory of mind (ToM) have common neuroanatomical aspects. This pilot study analyzed the qualitative features of ToM relatively to the site of prefrontal atrophy, aiming to identify a neurobehavioral pattern of bvFTD. METHOD: Fourteen bvFTD patients were compared with 14 healthy subjects with similar age, years of schooling, gender distribution, and social background. The faux pas task (FPT) measured the recognition and comprehension of faux pas (FP) and awareness of the factual details on 20 stories. Magnetic resonance assessed prefrontal atrophy. RESULTS: The bvFTD patients were significantly impaired in FP recognition and comprehension and in attribution of non-existent FP. Qualitative analysis revealed five types of errors: misidentification of characters, misidentification of emotions, excessive cohesiveness to the factual context, delusional interpretations, and non-responses. The FPT recognition and comprehension scores were unrelated to story factual details or other neuropsychological performance. Conversely, the FP comprehension scores related to disease duration, the delusional errors to disease duration and prefrontal orbital atrophy, and the cohesiveness errors to age and prefrontal dorsolateral atrophy. CONCLUSIONS: In bvFTD, ToM is characterized by misinterpretation of mental states and concrete thinking, which is related to disease severity and distinct areas of prefrontal atrophy. This neurobehavioral pattern may be a marker for bvFDT.

Initial results of a lung cancer screening demonstration project: a local program evaluation.

OBJECTIVES: To describe participation rates, results, and lessons learned from a lung cancer screening (LCS) demonstration project. STUDY DESIGN: Prospective observational study at 1 of 8 centers participating in a national Veterans Health Administration LCS demonstration project. METHODS: An electronic health record (EHR) algorithm and tobacco pack-year (TPY) information prompt identified patients potentially eligible for LCS. LCS invitation was planned to consist of shared decision-making materials, an invitation letter to call the LCS manager, a reminder letter, and an outreach phone call for nonresponders. The outreach call was subsequently dropped due to time constraints on the LCS manager. Lung nodules and incidental findings on LCS low-dose computed tomography (LDCT) were recorded in templated radiology reports and tracked with EHR notes. RESULTS: Of 6133 potentially eligible patients, we identified 1388 patients with eligible TPY information: 918 were invited for LCS and 178 (19%) completed LCS. LCS completion was more likely in patients in the mailing-plus-call outreach group (phase I) compared with the mail-only group (phase II) (22% vs 9%; P <.001). Among those completing an LDCT, 61% had lung nodules requiring follow-up: 43% of the nodules were less than 4 mm in diameter, 12 patients required further diagnostic evaluation, and 2 had lung malignancies. There were 179 incidental LDCT findings in 116 patients, and 20% were clinically significant. CONCLUSIONS: Important considerations in LCS are accurate identification of eligible patients, balancing invitation approaches with resource constraints, and establishing standardized methods for tracking numerous small lung nodules and incidental findings detected by LDCT.

Microbiological Control for Affinity Capture Chromatography Processing: An Industry Perspective.

The purpose of this paper is to provide a summary of a BPOG-led industry survey of the microbiological control aspects of affinity chromatography processing in the biopharmaceutical industry. The document provides a summary of historical microbiological control concerns, coupled with industry-derived best practices, for material, equipment, and storage controls required to mitigate the potential for microbial ingress and contamination of chromatography resin and equipment. These best practice guidelines, which are derived from the members of the BPOG Bioburden Working Group, are intended to assist biopharmaceutical manufacturers to enhance microbial control and monitoring strategies for chromatography systems.