CLINICAL PATHOLOGY LABORATORY MANAGEMENT AND ADMINISTRATION I

E.A. ASIAMAHUniversity of Health and Allied Sciences, Ho Ghana

INTRODUCTION Management is an integral aspect of the day-to-day life of the pathology laboratory and is a major requirement of the accreditation process required by legislation in some countries. This seeks to streamline the operations of the lab and to produce the best outcomes in fulfilment of the principle of value for money.

THEMATIC AREAS OF LAB MANAGEMENT & ADMINISTRATION: GOVERNANCE

Risk management Quality management Personnel management Financial management Relationship management

OPERATIONAL / SERVICE UNITS Histology service Autopsy service General cytology Cervical Cancer Screening / Testing service

ORGANIZATIONAL STRUCTURE:GOVERNANCE

RISK MANAGEMENT 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.

WHAT RISK MANAGEMENT SEEKS TO ACHIEVE

Issuing and enforcing standards for workplace safety and health. Implementing regulations that apply to all work situations. Examples: 1.Health and Safety at Work Act 1974.2.Control of Substances Hazardous to Health (COSHH) Regulations.3.Workplace (Health, Safety and Welfare) Regulations. 4.Health and Safety Offences Act 2008.

WHAT RISK MANAGEMENT SEEKS TO ACHIEVE CONTD… The overall goal is to ensure that employees are entitled to work in environments where risks to their health and safety are properly controlled (i.e. minimized).

RISK MANAGEMENT CONTD… 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.

RISK MANAGEMENT CONTD…

To comply with legislation and maintain accreditation, a laboratory must have an effective risk management policy.

BENCHMARKS FOR 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:• Identifying all risks that exist within the environment.• Assessing those risks for likelihood and severity.• Eliminating those risks that can be removed.• Reducing the effect of risks that cannot be eliminated.

RISK MANAGEMENT EXECUTION The laboratory manager would be concerned with all risks associated with the department that they manage. He/she must also be familiar with how these might impact on other areas of the organization such as porters transporting samples or chemicals to the laboratory.

RISK MANAGEMENT EXECUTION CONTD… They would also be required to alert the organization to the presence of risks which cannot be adequately controlled within or by the department.

RISK MANAGEMENT EXECUTION CONTD… 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.

RISK MANAGEMENT EXECUTION CONTD…

The team must also ensure risk management procedures are in place for every aspect of a laboratory’s processes and environment.

RISK MANAGEMENT EXECUTION CONTD… The laboratory manager must ensure that day-today 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.

KEY AREAS OF CONCERN Staffing levels and competence. Timeliness and quality of results. Budgetary management. Consumables and equipment supplies. Maintenance and infrastructural improvement.

SYSTEMATIC APPROACH TO STRATEGIC RISK ASSESSMENT. Risk identification Risk analysis/evaluation Risk management Risk funding

RISK IDENTIFICATION 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.

RISK IDENTIFICATION (CATEGORIZATION) CONTD… It is also useful to divide the risks into different categories, such as: clinical physical chemical infectious organizational financial political

RISK ANALYSIS / EVALUATION

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.

RISK SCORING

By scoring the risks for likelihood and severity, it is then possible to use a matrix to place a value on specific risks in order to help prioritize them for further action.

EXIGENCIES DOCUMENTATION 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 analyzed and areas possibly overlooked initially be risk assessed and managed.

SEVERITY AND LIKELIHOOD VALUESThe following is are examples of a severity scoring scale for incidents:1. LOW• Minor injury or harm• Minor loss of non-critical service• Minor non-compliance with standards• Minor out-of-court settlement• Publicity mostly contained within organization. Local press coverage of not more than one day.

SEVERITY AND LIKELIHOOD VALUES CONTD…2. SLIGHT

• Injury or harm requiring less than 3 days absence from work or less than 2 days hospital stay.• Loss of service for less than 2 hours in a number of non-critical areas or less than 6 hours in one area. Single failure to meet internal standards• Civil action with or without defense, improvement notice• Regulatory concern / local media coverage of less than 7 days

SEVERITY AND LIKELIHOOD VALUES CONTD…3. MODERATE

Medical treatment required and more than 3 days’ absence from work or more than 2 days’ extended hospital stay.• Loss of services in any critical area.• Repeated failures to meet internal standards or follow protocols.• Criminal prosecution or prohibition notice served.

SEVERITY AND LIKELIHOOD VALUES CONTD…4. SEVERE

• Fatality, permanent disability or multiple injuries.• Extended loss of essential service in more than one critical area.• Failure to meet national standards.• Executive officer fined or imprisoned, criminal prosecution no defense.• Political concern, questions in parliament, national media coverage greater than 3 days.

SEVERITY AND LIKELIHOOD VALUES CONTD…5. CATASTROPHIC

• Multiple fatalities.• Loss of multiple essential services in critical areas.• Failure to meet professional standards.• Imprisonment of executive from organization.• Full public enquiry.

EVALUATION OF LIKELIHOOD BY INCIDENTS SCORESIncidents may also be scored 1–5 for likelihood:

1. Incident unlikely to occur.

2. Incident likely to occur once in a 5-year period.

3. Incident likely to occur yearly.

4. Incident likely to occur once in a 6-month period.

5. Incident likely to occur once every 4 weeks or more frequently.

THE RISK FACTOR IS THE SEVERITY MULTIPLIED BY THE LIKELIHOOD OF OCCURRENCE:

Very Low Risk– The majority of control measures in place or harm/severity small. Action may be long term.

Low Risk– Moderate probability of major harm or high probability of minor harm if control measures are not implemented. Action in the medium term.

Moderate Risk –Urgent action to remove or reduce the risk.

High Risk– Immediate action to remove/reduce the risk.

RISK FUNDING May include insuring individual members of staff and the laboratory facility.

All staff must carry medical liability insurance, which covers them in the event of any negligence claims.

Similarly, professional indemnity insurance is commonly available today for non-medical laboratory staff who are much more at risk in today’s litigation-conscious society.

The decision regarding whether or not to insure should be based on the risk assessment and the severity and likelihood of the risk.

Some risks will not be appropriate for insurance cover for whatever reason, and in these instances the risk must be accepted by the organization.

QUALITY MANAGEMENT A quality management system is essential in order 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).

TYPES OF QUALITY MANAGEMENT SYSTEMS (QMS) Internal QMS

Internal quality control (IQC) systems are utilized to check work processes as an important part of quality management, and has been the traditional way that bench work has been checked for many years. It also includes processes utilized in the laboratory to recognize and eliminate errors.

TYPES OF QUALITY MANAGEMENT SYSTEMS (QMS) External QMS Utilizes External quality assurance (EQA) schemes which provide benchmarks against other laboratories and often provide access to best practice methods and expert advice on improving techniques / specific tests.

FACTORS THAT INFORM AN EFFECTIVE INTERNAL QMS

Organization and liaison with users. Premises, equipment and materials. Examination procedures (SOPs) Continuous quality improvement (CQI).

KEY FEATURES OF A ROBUST QMS A full quality management system should

also encompass systems to ensure: consistency quality of service confidence standardization continual improvement of all laboratory processes through monitoring and evaluation.

STAKEHOLDERS (FACTORS) THAT INFLUENCE IMPLEMENTATION OF QMS Patients / Clinicians Human resources Work premises Local environment Equipment resources Information and Technology systems Materials

PHASES OF APPLICATION OF QMS

Pre-examination phase Examination phase Post-examination phase

QMS APPLICATIONS: EXPECTED OUTCOMES A proper application of the QMS throughout the production cycle will ensure regular auditing of the various components of the systems. Will provide evidence of compliance with standards for accreditation. It will also identify any trends and issues for concern, and confirm quality systems are working. Overall, all these measures will identify areas for quality improvement and show whether any improvements are working.

ACCREDITATION : INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO).

ISO 15189 – Medical laboratories – Particular requirements for quality and competence. This is the main standard that affects medical laboratories and that the majority will seek to become accredited to.

ISO 17043 – Conformity assessment – General requirements for proficiency testing. This standard specifies general requirements for the competence of providers of proficiency testing schemes, which would include external quality assurance schemes.

ISO 17011– Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies.