2. Quality System Essentials (QSE) Organization and Leadership

Organization of a Quality Management System requires the support of a number of people and/or groups in order to operate effectively. According to the CLSI (2019), the following policies, processes and procedures are needed to support the QSE Organization and Leadership.

Policies of the organization state the intent and direction for

• Commitment to quality and good professional practice
• Designing the organizational structure to ensure quality practices
• Effective implementation of the QMS
• Planning for quality
• Allocating resources for both the QMS and service operations
• Periodically reviewing the status of the QMS (Management)
• Communication

Processes are activities that transform the intent of the policies into action

• To develop and maintain the organization’s quality policy, as well as the quality goals and objectives needed to carry out that policy
• To define, implement, and maintain the scope of practice required to meet customer needs
• define the roles and responsibilities required to carry out the work processes and activities of the QMS
• To design and implement the QMS
• To develop and maintain the quality manual and to integrate it into the laboratory and the overall organization
• Allocating the resources for facility, human, equipment, and materials required to support the QMS and to provide the ongoing laboratory services
• To prepare the quality report
• To review performance data and information to evaluate the effectiveness and efficiency of the QMS
• To support and guide continual improvement in the organization
• To communicate essential information to external customers and to receive communication from staff regarding quality, safety, or ethics

Procedures

• For defining the scope of the QMS
• For maintaining the organization’s legal entity
• To review and revise the quality goals and objectives, as well as creating the quality report
• For conducting quality management reviews, defining and prioritizing tasks
• For the creation and maintenance of a communication plan that addresses staff and customer concerns

Management Involvement

In order for the implementation of a QMS to succeed, there must be support from higher management. As you will remember from our discussion last week about the costs of quality, the development and implementation of the system requires resources – both financial and human – so there has to be designated funding available. Time is needed to provide education and training on the use of the QMS as well so that’s also an added cost. In order to get “buy-in” from staff to use the system, Management must lead the implementation. Staff needs to be educated to the benefits of using a QMS and they must be trained on how to use it. If they don’t understand the value of using it, the QMS will likely never be utilized effectively. Finally, a Management review must be scheduled regularly to ensure that the QMS is operating as intended and that it is still meeting the needs of the customers it serves.

Quality Planning

Management plans for the development and implementation of the QMS, start with a quality policy. Decisions must be made on the scope of the laboratory services to be provided, a vision and mission for the QMS must be developed, and decisions have to be made about which individuals will be responsible for the development and implementation of the policy statements for each QSE. In most labs, Management would also have to collaborate with other areas of the organization to put quality practices in place with regard to QSEs such as Purchasing, Finance, and Human Resources since those functions would typically be operating outside the laboratory division.

Quality goals and objectives are the outcomes of quality planning. The goals are the broad statements of what the program hopes to achieve and they make the vision become more real to staff. The objectives are the specific short-term conditions or achievements of the goal. There can be several objectives related to any one quality goal.

Quality Manager

Management must appoint a person to perform the functions of a Quality Manager. That person would be responsible for, and have the authority for, overseeing compliance with the policies, processes and procedures of the QMS. The Quality Manager usually reports directly to the Senior Management of the lab. Some of the required knowledge and skills that a Quality Manager needs to possess to succeed in this role include the following:

• formal training in QMS
• training and experience in medical laboratory science
• training and experience in auditing techniques
• good communication skills, both verbal and written
• good negotiation skills

Some of the responsibilities of the Quality Manager include:

Review and approval of SOPs and training programs

1. Review and approval of validation plans for equipment
2. Review and approval of document control and record keeping functions
3. Auditing operations
4. Develop criteria for evaluating systems
5. Review and approval of suppliers, products and service agreements
6. Review of reports of non-conforming events and corrective action plans
7. Review of data to identify trends and potential problems
8. Preparation of Quality reports (Roback, 2011, p.5-6)

Quality Steering Committee

The Quality Steering Committee (Quality Oversight group) is generally made up of a broad representation of staff and management from all areas of the lab. They are responsible to oversee the implementation of the QMS in their particular sections of the lab. They also act as the Change Agents for the implementation. It is these people who promote the benefits of using a QMS and who continue to work with the Quality Manager to provide ongoing support for the system.

Allocation of Resources

It is the responsibility of the Management Team to ensure that resources are distributed in such a way as to ensure that sufficient resources are available to conduct the laboratory’s business. The budgeting process must include the quality activities that are deemed necessary to carry out the work of the QMS. Included in the work are such activities as performing ongoing quality activities, carrying out the laboratory’s operations, supporting continual improvement initiatives, and allotting the resources needed to carry out the quality goals and objectives. Resources that would be needed for these activities include:

• facility operation, maintenance and upkeep
• human resources to effectively staff the laboratory with the appropriate skills and expertise
• dedicated time to allow staff to work on the goals and objectives built into their schedules so that the implementation is recognized as a priority of the organization
• capital funding for new equipment
• material resources to allow for procedures and activities to be completed
• resources for both planned and unplanned operational changes that may be required throughout the year

Underlying all of these resources lay the three fundamental resources of Time, People and Money. Without all three of these resources committed to the implementation, it cannot possibly be successful.

Communication

Communication takes place between staff who work on different shifts. Testing may have to be repeated at regular intervals on a particular patient, an analyzer may be acting up, or another staff member may have called in sick. When the person relieves the evening staff at 11pm, how do they know what important pieces of information may be needed to carry out the night’s work? Having a communication log is one method that could be used, or having a change of shift meeting between the 2 shifts could be another.

Communication may also be required to pass information from staff to supervisors, or from supervisors to staff, so that everyone on the laboratory team is kept up to date on current happenings. Email, bulletin board notices and staff meetings are all ways that may be used for these types of communication. Sometimes, there is a need to arrange a more formal meeting between a staff member and the supervisor, or even with a small group of staff.

Communication also occurs between the laboratory and the patients/customers it serves. Perhaps the instructions for collecting a timed urine sample have to be given out, or a phlebotomist has to help a patient prepare to have blood drawn. It may be necessary to announce a change to blood collection clinic hours or to explain to an elderly patient what the process is for dropping off a specimen in the Receiving area. Each of these situations may require a different type of communication to make sure that the message is delivered and received.

Finally, communication that laboratory staff may have to participate in is communication between themselves and other healthcare workers.

What are some examples of these types of communications and how can they be used effectively?

Keeping all these various types of communication needs in mind, there are several different considerations that should be taken into account:

• What is the key message or content to be communicated?
• Who is the readership?
• How often will this communication be shared?
• How urgent is the communication?
• What mode of communication will be used?
• Whose responsibility is it to communicate this information?

Having a documented communication plan in place helps to ensure the effective, timely communication of essential information to both internal and external stakeholders.

Consistency in communication is vital. It is very important to make sure that information is being communicated consistently so everyone receiving a particular message receives the same information.

The final important point is that staff must be comfortable communicating concerns to the supervisor/manager. Many organizations have a process for staff to communicate quality concerns safely and confidentially.