Crisis Management for Biobanks.

All organizations are subject to risk and uncertainty. Adverse events may disrupt normal organizational activity and may even cause complete failure of business operations. Biorepositories are also at risk and there have been instances where multiple samples or entire collections have been destroyed. Biobank guidelines accordingly recommend the establishment of contingency plans to reduce risk to an acceptable level. In this review article, we will use general theory on risk management and illustrate how such principles can be used to establish a practical crisis management plan for any biobank organization.

Research findings with clinical implications.

BACKGROUND: Medical and health research may yield findings that are of direct clinical significance for project participants. The Council of Europe has stated that information on such findings shall be offered to participants, and that applications to research ethics committees shall include plans for managing such findings. The purpose of the study was to investigate how the management of such findings had been described in research projects that had been granted prior approval by a regional committee for medical and health research ethics (REK). MATERIAL AND METHOD: Research projects that were associated with Oslo University Hospital and had a start-up date in 2011 were identified in the database of the regional ethics committee. Copies of the application form submitted to the committee, project protocols, participant information/consent forms and letters of approval were reviewed with regard to information on the management of findings with possible clinical implications. RESULTS: Of the 87 projects found in the database, 70 were included in the study. Of these, 57 studies involved direct interaction with humans, whereof 45 with intended use of biological material. In 21 studies, the management of findings with possible clinical implications was described in one or more documents. In all of these projects, the applicant him-/herself had referred to this topic in the initial application. INTERPRETATION: The absence of written information on the management of research findings with possible clinical implications is not in conformity with the recommendations issued by the Council of Europe. By introducing a separate item for this in the form to be submitted to the regional ethics committee for application of prior approval, this issue could be made subject to better assessment.

Implementation and use of electronic synoptic cancer reporting: an explorative case study of six Norwegian pathology laboratories.

BACKGROUND: The information contained in histopathology reports on surgical resections of cancer is fundamental for both patient treatment and cancer registries. Electronic synoptic histopathology reporting is considered superior to traditional narrative reporting with respect to both completeness and feasibility of data use. An electronic template for colorectal cancer reporting was introduced in Norway in 2005, but implementation has varied greatly between different pathology departments. In 2012, four pathology departments and the Norwegian Cancer Registry started a new initiative on electronic cancer reporting. As part of this initiative, this study was undertaken to learn more about factors influencing implementation and use. METHODS: Qualitative and quantitative data were obtained from six of the 17 public pathology departments in Norway using explorative case study methodology. Methods included document studies, semi-structured interviews with key informants, and audits on actual template use. A systematic analysis of data was conducted based on theoretical models for project management, stakeholder engagement, and individual acceptance of new information technology. RESULTS: Most key informants had a positive view on synoptic reporting, and five departments had tested the electronic template. Of these, four had implemented the template while one department had decided not to implement it due to layout concerns. Of the four departments using the template in daily routine, one had compulsory use, two consensus based use, while the fourth had voluntary use. Annual average usage of the electronic template in the three departments with compulsory or consensus based use was 92% compared to 53% in the department with voluntary use. CONCLUSIONS: There was a general positive attitude towards electronic synoptic reporting. Reasons for not implementing the colorectal template were specific technical and quality issues not adequately addressed by the project organization having developed the template. A formal assessment of project outcomes with a task force handling such technical issues should accordingly have been established as part of the project. After an organizational decision on implementation, perceived job relevance and practical benefits are factors important for individual template use. Consistent high long-term usage was related to a departmental environment with a consensus based decision on use.

Structured electronic health records.

In order to succeed in realising general health-policy goals for cancer care, they must be formulated as specific and realistic objectives. An administrative organ must be provided with the authority and funding needed to establish the technical solutions required. Reporting to national registries must take place automatically in electronic form, on the basis of ongoing structured reporting in the patient records. In our opinion the Directorate of Health should enter into cooperation with the College of American Pathologists, with a view to integrating a Norwegian version of their electronic checklists for pathology reporting of cancer into the hospitals' record systems.

Learning by Erring: fire!

Biorepositories may be affected by a number of emergencies ranging from bad publicity to natural disasters, and biorepositories should have plans for handling such situations. The emergency management process includes all phases from mitigation to recovery. Fire is one disaster that may cause extensive damage to both physical structures and humans. In this article, we analyze events related to a fire in a storage facility for mechanical freezers. The analysis covers both the pre-crisis stage, the fire itself, and the post-crisis stage. Even the best intended planning cannot stop a crisis from happening. However, an open-minded analysis of the crisis with focus on learning and quality improvement can improve an organization's ability to handle the next emergency situation.

Retrospective review of diagnostic histopathology samples in research projects: transparency should be the practice with respect to diagnostic discordance.

Retrospective review of diagnostic histopathology samples in secondary research projects may generate cases with discordance in diagnosis between the pathologist originally signing out the sample and the reviewer. In this article the authors discuss ethical and legal issues involved in secondary review and propose how diagnostic discrepancies in research projects can be handled. Research participants have the right to know about and control the handling of personal data. Researchers have a duty to inform research participants about research findings of relevance to the current or future health or quality of life. Such feedback is to be provided within a healthcare framework. The authors recommend that pathology laboratories should require researchers to provide feedback on diagnostic discrepancies of potentially clinical significance in secondary research projects using retrospective review of diagnostic histopathology material. The pathology laboratory in charge of the archival material should be responsible for the follow-up on such cases.

Structured electronic template for histopathology reporting on colorectal carcinoma resections: five-year follow-up shows sustainable long-term quality improvement.

CONTEXT: To improve quality, pathology organizations have published guidelines with key parameters for histopathology reporting on cancer resections. Checklists or structured templates improve upon the presence of key parameters in histopathology reports, but data are lacking on long-term sustainability of such reporting. From 2003 to 2006, the Cancer Registry of Norway and the Norwegian Society of Pathology collaborated on the development of a structured electronic template for histopathology reporting on colorectal carcinoma resections. OBJECTIVE: To investigate use and long-term effect of this structured template in one of the first laboratories implementing the template for routine diagnostic work. DESIGN: All histopathology reports (n =123) in the 1-year period prior to implementation were evaluated with respect to presence of key parameters. Likewise, all histopathology reports (n =1186) in the 5-year period after implementation were evaluated with respect to template use and presence of key parameters. RESULTS: The electronic template had been used in 1089 (91.8%) of the 1186 cases. Template use was stable in the entire 5-year period, and had significantly improved upon the presence of data on 7 of 11 key parameters valid for both the pre-implementation and the post-implementation period. Eight hundred and twenty-two (75.5%) of the 1089 template reports contained information on all key parameters, compared to just 20 (16.3%) of the 123 free text reports in the 1-year pre-implementation period. CONCLUSION: Electronic template reporting has a significant and sustainable long-term, positive effect upon the quality of histopathology reports.

Human cells and the Norwegian Health Research Act.

The use of cells and cell lines is essential to the development of new knowledge and better medical therapies. Society is served by transparent and predictable regulations and practices on the use of human derived material. The National Committee for Medical and Health Research Ethics should publish guidelines setting out clearly how researchers should act with respect to such research.

Stakeholder analysis: a useful tool for biobank planning.

Stakeholders are individuals, groups, or organizations that are affected by or can affect a particular action undertaken by others. Biobanks relate to a number of donors, researchers, research institutions, regulatory bodies, funders, and others. These stakeholders can potentially have a strong influence upon the organization and operation of a biobank. A sound strategy for stakeholder engagement is considered essential in project management and organization theory. In this article, we review relevant stakeholder theory and demonstrate how a stakeholder analysis was undertaken in the early stage of a planned research biobank at a public hospital in Norway.

Template reporting matters--a nationwide study on histopathology reporting on colorectal carcinoma resections.

Complete and accurate histopathology reports are fundamental in providing quality cancer care. The Cancer Registry of Norway and the Norwegian Society of Pathology have previously developed a national electronic template for histopathology reporting on colorectal carcinoma resection specimens. The present study was undertaken to investigate (1) whether quality routines in Norwegian pathology laboratories might affect completeness of such histopathology reports and (2) whether the national electronic template improves completeness of histopathology reports compared with other modes of reporting. A questionnaire on quality routines was sent to the 21 pathology laboratories in Norway. All histopathology reports on colorectal cancer submitted to the Cancer Registry for a 3-month period in the autumn of 2007 were then evaluated on the mode of reporting and the presence of 11 key parameters. Of the 20 laboratories that handled resection specimens, 16 had written guidelines on histopathology reporting. Of these, 4 used the national electronic template, 5 used checklists, 3 used locally developed electronic templates, whereas the remaining 4 had neither obligatory checklists nor templates. Of the 650 histopathology reports submitted to the Cancer Registry in the 3-month period, the national template had been used in 170 cases (26.2%), checklists/locally developed templates in 112 cases (17.2%), and free text in 368 cases (56.6%). Quality routines in the pathology laboratories clearly governed reporting practice and the completeness of the histopathology reports. Use of the national electronic template significantly improved (P < .05) the presence of the 11 key parameters compared with reporting by checklists, locally developed electronic templates, or free text.

Structured electronic template for histopathology reports on colorectal carcinomas: a joint project by the Cancer Registry of Norway and the Norwegian Society for Pathology.

Both individual patient treatment and cancer registries depend on adequate histopathology reports. To ensure the quality of these reports, professional organizations have published guidelines on minimum data sets for various cancer types. Norway has a population of 4.6 million, and all individuals have a unique identification number. As required by law, relevant information on cancer is submitted to the Cancer Registry of Norway. A closed, national health data network has been established facilitating electronic transferal between various institutions. The Cancer Registry and the Norwegian Society for Pathology have jointly established a nationwide project to (i) develop standardized templates in database format for histopathology reports on cancer resection specimens and (ii) develop an Extensible Markup Language (XML) standard to facilitate future electronic transfer of cancer reports from hospitals to the Cancer Registry. A minimum data set template for reporting colorectal carcinoma resection specimens and the Extensible Markup Language standard have been established. The template is based on international guidelines and classification systems. For most key parameters, pull-down menus with predefined alternatives have been constructed. The template is fully integrated into software being used by all pathology laboratories in Norway. Since the introduction of the template in April 2005, the template had been used for reporting 430 (93%) of 462 colorectal resections at 2 pilot laboratories (Akershus University Hospital [Lørenskog, Norway] and Stavanger, University Hospital [Stavanger, Norway]), demonstrating that high and consistent quality can be ascertained. Pathologists have found the template both time saving and user friendly. The template is now gradually implemented nationwide.

Effects of long-term sensory deprivation on asymmetric synapses in the whisker barrel field of the adult rat.

Whisker trimming deprives the cortical barrel field from the patterned sensory input that derives from active touch but leaves passive tactile signals unaltered. We have studied in the rat barrel field, by stereological procedures, the effects of a sustained period of unilateral deprivation by whisker clipping during adolescence and early adulthood on (1) the surface density (SV) of asymmetric synapses, as determined from measuring the presynaptic membrane specializations, and (2) the numerical density of asymmetric synaptic profiles (NA), classified according to their postsynaptic target and their apparent curvature. Compared to control rats, the procedure did not change the overall volume of the region, the volume fraction occupied by each cortical layer, or the volume fraction occupied by unmyelinated axons and boutons. However, the deprived barrel cortex displayed an increase in SV in layers I and II, and an increase in NA in layer I and in the cortex as a whole, mainly due to an increase in profiles with a convex shape. Layer IV was the least affected by the deprivation. These results point to a net increase, rather than a decrease, of excitatory synapses in the deprived cortex, which could result from a deprivation-induced decrease in the rate of normal synapse loss. This effect occurs specifically in superficial layers, more involved in intracortical and cortico-cortical, rather than thalamo-cortical, processing.

The size of the whisker barrel field in adult rats: minimal nondirectional asymmetry and limited modifiability by chronic changes of the sensory input.

We have evaluated quantitatively the whisker barrel field (posteromedial barrel subfield, PMBSF) size in rats raised in standard cages and in rats chronically exposed to an enriched sensory environment. Some animals were subjected to either chronic trimming of the right whiskers, or permanent transection of the right infraorbital nerve. Coronal brain sections were Nissl-stained or reacted for cytochrome oxidase. All, except the IoN-transected rats, showed +/-5% variation in mean PMBSF thickness, with no consistent side bias. In the transected animals, however, the left PMBSF was a significant 3.1% shallower than the right. This denervation-dependent radial shrinkage was consistent with an 11% volume shrinkage of the deafferented PMBSF. The mean volume of the PMBSF ranged between 8.7 and 9.5 mm(3), with moderate interindividual variability (3.5% to 11%). No significant differences in PMBSF volume were found between groups in the right hemisphere, nor in the right vs. left ratios. However, the PMBSF volume was a significant 6.6% larger in the enriched animals without whisker trimming. The PMBSF volume correlated positively with neocortical volume, and with PMBSF cortex thickness, in rats exposed to enriched environment. These data show that: (1) there is a moderate interanimal and lateral variability in the PMBSF volume, with no side preference; (2) exposing young adult rats to an enriched environment induces a discrete but significant enlargement of the PMBSF; (3) the effects of whisker trimming on the contralateral PMBSF, if any, are lost in the interanimal and lateral variability; and (4) such changes reach significance, however, when studied in combination with exposure to an enriched environment.