1 Managing the laboratory
Management is an integral aspect of the day-to-day life of the histopathology laboratory and is a major requirement of the accreditation process required by legislation in some countries. The accreditation standards include management as part of the evaluation and it is necessary that the laboratory worker is familiar with all of the processes involved. There are excellent books available which cover management issues in depth, and it is not the objective of this chapter to be a comprehensive guide to the subject. Rather, it discusses and concentrates on specific areas which have an impact on the operation of the laboratory; namely:
A pathology service may include a histology laboratory, an autopsy service, general cytology and a cervical screening/testing service. These areas will have many common management requirements but there will be some areas such as risk management where the issues will be individual to that section.
The surgical biopsy is sent for histopathological assessment to corroborate or dispute a clinical diagnosis by providing confirmation of data provided from other diagnostic tests. It should provide the clinician with valuable information on how to proceed with the treatment of the disease. Some resection specimens are taken as part of the treatment process, being referred to confirm the diagnosis, ensure adequate resection margins, to determine the extent of lymphatic/vascular involvement, staging, likely outcome and prognosis. Aside from simply determining a cause of death, autopsies may provide definitive data for a medical audit. They may be used to determine where medical procedures have been ineffective, or may give additional data for the future treatment of other patients. They can also provide a much needed final diagnosis and resolution for relatives.
Cytology samples are used as a screening process (e.g. cervical smears) and may assist in the early diagnosis of disease prior to the development of symptoms and thereby enable effective treatment. Cytology tests can also be used to monitor the stage of disease before/after treatment. This is accomplished by using non-invasive or minimally invasive techniques, which have a low risk of complications to the patient.
Risk management is an essential and central part of all laboratory work. Organizations such as the Health and Safety Executive (HSE) and the Health Protection Agency (HPA) exist to ensure the safety of employees, patients and the general public in the United Kingdom. In the USA the Occupational Safety and Health Administration’s mission is to prevent work-related injuries, illnesses, and occupational fatality by issuing and enforcing standards for workplace safety and health, and most countries will have equivalent bodies and standards.
Regulations made under the Health and Safety at Work Act 1974 apply to all work situations, for example the Control of Substances Hazardous to Health (COSHH) Regulations and the Workplace (Health, Safety and Welfare) Regulations. The HSE enforces this act along with others, including the Health and Safety Offences Act 2008. The overall message is that that employees are entitled to work in environments where risks to their health and safety are properly controlled (i.e. minimized). Under health and safety law, the primary responsibility is owed by employers, with employees expected to ensure their own safety, and that of their colleagues and/or patient’s by adhering to policies and procedures.
To comply with legislation and maintain accreditation, a laboratory must have an effective risk management policy. Any chance of something going wrong should be either negated or minimized, and therefore a laboratory’s risk management process should have procedures in place for:
The pathology laboratory should have close links with, and feed into, the host organization’s risk management process. In most hospital laboratories, the laboratory manager will be accountable for risk management and the health and safety of the staff in their department, and often will be supported by a Risk Lead who will be responsible for the operational aspects of the system.
To function effectively and safely, all of a laboratory’s procedures and activities must be subjected to the risk management process. The risks in the laboratory are similar worldwide, albeit with a variation due to local circumstances. Health and safety and quality assurance incorporate a major aspect of risk management. All aspects of our working life incorporate a degree of risk and the risk management process allows us to prioritize, evaluate, and handle the risk appropriately. It is not possible to avoid or eliminate all risks, and in reality this may not be practical. It is important to identify and understand the risks that are involved in a laboratory’s working practices. An individual’s responsibility for risk management is dependent upon that individual’s role within the organization. The Chief Executive, for example, will be concerned mainly with risks associated with strategic issues affecting the organization as a whole and would only include histopathology within the risk assessment if it had a direct impact on these issues. Matters concerning the day-to-day running of the laboratory would not be of direct interest unless, of course, there was a significant reason for involvement such as major clinical or financial concerns or unmanaged risks or incidents, especially those likely to cause harm to patients, cause the organization to fail to achieve agreed targets or might attract adverse media publicity. A laboratory manager would be concerned with all risks associated with the department that they manage, but also how these might impact on other areas of the organization such as porters transporting samples or chemicals to the laboratory. They would also be required to alert the organization to the presence of risks which cannot be adequately controlled within or by the department.
The laboratory management team will deal with any laboratory-associated risk by ensuring that adequate resources are available to deliver the service, and by guaranteeing that the laboratory provides a service that is safe both for staff and patients. Staffing levels and competence, timeliness and quality of results, budgetary management, consumable and equipment supplies, and maintenance are some of the areas of concern. The laboratory management team must also ensure risk management procedures are in place for every aspect of a laboratory’s processes and environment.
The laboratory manager must ensure that day-to-day errors do not arise as a result of inadequacies in laboratory procedures and that quality control checks are in place to minimize the possibility of human errors: for example, a transcription error or mislabeling. Standard operating procedures (SOPs) should include COSHH data, risk assessments or equivalent, and also to include other health and safety information relevant to the procedure. This should include national legislation and guidance where available.
Scientific and support staff at the bench may be exposed to risks involving equipment malfunction due to poor maintenance or design. Poor-quality reagents may produce poor processing of tissues or inaccurate staining results. One of the most common accidents in the histopathology laboratory is the injury to fingers or hands from microtome blades or laboratory knives. It is the responsibility of each laboratory worker to reduce the risks associated with their day-to-day work by working in accordance with SOPs and associated risk and COSHH assessments. This will help ensure that everyone is working to the same standard and understands what is required to minimize risk to themselves, their colleagues and/or patients. It is importance that where risks are identified, the risk management measures which are put in place are regularly audited to assess whether they are being followed and are still appropriate and effective.
The risks within each laboratory section are best identified by the section lead and members of that team, working in conjunction with the laboratory’s health and safety lead. This ensures that the broadest possible spectrum of viewpoints is considered. During this process it is also useful to divide the risks into different categories, such as clinical, physical, chemical, infectious, etc., and even organizational, financial and political, depending on the area being risk assessed. For example a support worker unpacking the samples delivered to the laboratory might have noticed that more samples than usual have leaked. This could put both themselves and the porter at risk from infection and exposure to fixative, and if any of the contents has leaked beyond the specimen bag there could be a risk to other health workers and patients/visitors using the same route. This could just be a problem with one batch of specimen pots, but could also be a training issue for staff putting the samples in the pots. In raising the issue with their supervisor and giving them the opportunity to investigate the root cause, the support worker may have prevented harm to others and potential damage to the sample.
Analysis and evaluation of potential risks is an essential part of the process, and one that is used to identify both the likelihood and severity of these risks. By scoring the risks for likelihood and severity, it is then possible to use a matrix such as the one described below as a tool that will put a value on specific risks. This will then help prioritize them for further action.
The risk manager should put a system in place whereby all incidents and accidents are reported no matter how small. It is only by recording data that the full picture can be obtained and analysed and areas possibly overlooked initially be risk assessed and managed.