Pathology laboratory management

Introduction

Management of the histopathology laboratory in today’s environment requires a balancing act of technical knowledge, business skills, fiscal responsibility, understanding of the workforce and a quality focus. Many of today’s managers have ‘risen through the ranks’ and have a solid foundation of technical skills on which to build, but may need to hone their leadership and management skills. There are excellent books available which cover management issues in depth, see further reading . The objective of this chapter is not to be a comprehensive guide to the subject, but discuss and concentrate on specific areas which are unique and significant to the operation of the laboratory, namely:

• Regulation and Accreditation.

• Quality Management in the laboratory setting.

• Safety concerns specific to Pathology.

The laboratory manager is accountable for the service provided by the laboratory and for the safety and well-being of their staff. It is imperative that the manager remains up-to-date on regulatory and technical changes as well as safety and quality requirements.

Regulation and accreditation

Governmental and national standards have been set to assure that laboratories meet minimal standards in order to protect the public.

In the USA, the Clinical Laboratory Improvement Amendments (CLIA), are federal regulatory standards which apply to all clinical laboratory testing performed on humans. The Centers for Medicare and Medicaid Services (CMS) have responsibility for the operation of the CLIA program with the objective of ensuring quality laboratory testing.

CMS, through CLIA, inspects and certifies all laboratories, either directly or through voluntary organizations with deemed status such as the College of American Pathologists (CAP) or the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Failure to pass a CLIA, CAP or JCAHO inspection can result in revocation of a laboratory’s license to practice. On-site inspections are generally conducted every two years, with self-inspections done in the intermediary years. When deficiencies are discovered, the laboratory is given the opportunity to correct the problem before any disciplinary action is taken. A full catalog of all required standards for the CLIA and CAP can be obtained on line using the websites in further reading . These extensive standards cover all aspects of laboratory operations including the facility, personnel, test performance, safety, quality assurance and quality control. The standards are updated regularly and it is wise to assure that you are working from the most recent set of regulations.

In the UK, the quality of the clinical laboratory service is certificated through accreditation to the laboratory standards pertaining to ISO15189 and previously to Clinical Pathology Accreditation (CPA) standards, rather than through licensing. This is explained further in the section below.

If a laboratory performs any of the licensable activities regulated by the Human Tissue Authority (HTA), such as the processing and storage of post mortem tissue, then an HTA license under the relevant sector is required (for website see further reading ). The HTA was established under the Human Tissue Act and inspects establishments carrying out licensable activities to ensure the requirements of the Act are being met. The establishment must demonstrate at inspection how it meets the standards laid out by the HTA, including quality and governance systems, equipment and facilities in order to retain their licence.

Accreditation

Accreditation in the American pathology laboratory is a voluntary process to confirm that the department meets specific standards for testing, staffing and quality services. Accrediting agencies often have more stringent requirements than the minimal governmental regulations, so laboratories may choose accreditation to identify themselves as a higher quality organization.

CAP is a leading organization which serves patients, pathologists and the public by promoting excellence in the practice of pathology and laboratory medicine worldwide. It provides peer-conducted inspections on a bi-annual basis. Along with accreditation, CAP also offers educational and proficiency testing programs to promote quality practice.

The Joint Commission is an independent, not-for-profit organization which accredits and certifies nearly 21,000 healthcare organizations and programs in the United States. Joint Commission accreditation and certification is recognized as a symbol of quality which reflects an organization’s commitment to meet certain performance standards.

The International Organization for Standardization (ISO) standards are being adopted by many as the standards they wish to work to and be accredited by. ISO is the world’s largest developer and publisher of international standards which cover many areas of activity; the ones which affect medical laboratories are:

• ISO 15189 – Medical laboratories – Requirements for quality and competence. This is the main standard which affects medical laboratories and to which the majority will seek to become accredited.

• ISO 17043 – Conformity assessment – General requirements for proficiency testing. This standard specifies general requirements for the competence of providers of proficiency testing schemes. This includes external quality assurance schemes.

• ISO 17011 – Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies . To assess and accredit laboratories by ISO standards within their own country. National accreditation bodies such as the CPA in the UK must themselves be accredited under this standard.

• ISO 27001 – Information Security Management Standard (ISMS). This provides a framework for information security standards. Laboratories may be expected to demonstrate how they conform to these standards when responding to tenders for external work.

In the UK, clinical laboratories are accredited by the United Kingdom Accreditation Service (UKAS) to the ISO15189 standards which cover all aspects of the laboratory, from the management structure of the organization and quality management system to competence of personnel, suitability of equipment and the validity and quality assurance of test methods. Laboratories are assessed on an annual cycle, accreditation is not as a laboratory, but at test level. A list of accredited tests for each clinical laboratory is available on the UKAS website, see further reading .

Unaccredited clinical laboratories may struggle to remain viable if they are unable to demonstrate the quality and accuracy of the test results they provide. The National Health Service (NHS) England advise commissioners to prioritize accredited diagnostic services, stating that accreditation should be seen as the ‘ baseline standard for diagnostic services across the NHS in England’ (see website in further reading ).

Laboratories must also achieve accreditation by the Institute of Biomedical Science (IBMS) if they wish to train persons to become registered Biomedical Scientists. The IBMS inspects laboratories to ensure that they demonstrate the required standard of service and training provision before granting accreditation.

Quality management

A robust quality management system is essential to provide the best possible service for the patient and clinicians. Quality is defined as a measure of how well a product or service does the job for which it is designed, i.e. conformity to specification.

Internal quality control (QC) of work processes is an important part of quality management and has been the traditional way that bench work has been checked for many years. External quality assurance (EQA) schemes provide benchmarking against other laboratories and often provide access to best practice methods and expert advice on improving techniques/specific tests. However, a full quality management system should also encompass systems to ensure consistency, quality of service, confidence, standardization and continual improvement of all laboratory processes. Quality management of a laboratory should ensure that there are systems in place to monitor and improve areas such as organization and quality management systems. This will involve liaison with users, human resources, premises, the local environment, equipment management, information systems and materials. It will address the pre-examination process, the examination process, and the post-examination phase as well as evaluation and quality assurance. Regular audit of the various components of the system will provide evidence of compliance with standards for accreditation. It should identify any trends and issues for concern, and confirm quality systems are working. Taken as a whole, all of these measures should identify areas for quality improvement and show whether any improvements are working.

Process improvement

This is the system which is used proactively to approach and identify opportunities to improve quality before problems occur. It operates through evaluation and audit of all systems and processes in the laboratory. The goal is to improve care and safety for patients and staff through recognition of potential problems and errors before they can occur. Good managers realize that failures, errors and problems are often due to the system processes, and not necessarily the fault of the employee(s).

Regular and thorough auditing of the many components of the laboratory’s quality management system and performance should be mapped against accreditation standards. This will help highlight any problem areas. Feedback from users provides useful information when evaluating the effectiveness and quality of the service. Any criticism received may prompt an unscheduled audit of that part of the system.

Continuous Quality Improvement (CQI) should include auditing of the laboratory’s procedures against, not only accreditation standards, but also those of the host organization/other services. Any audit findings which show that the laboratory’s processes are not adequate should result in corrective actions. These audit findings may also highlight opportunities for improvements in processes, documentation, staff training, or monitoring aspects of competence. Any corrective actions required should be completed as soon as possible so that services can be improved and brought up to the correct standard quickly. CQI is a continuous cycle of audit and assessment of the service. If not monitored regularly, quality standards can slip as staff, equipment and reagents change. It is useful for the manager to establish an audit calendar to ensure that all areas are audited regularly, paying particular attention to ‘problem areas’.