Quiz 1

Question 1

Pre examination phase -
Test selection,
sample collection,
Sample transport

Laboratory analysis examination phase

Post examination phase-
report creation,
report transport

Question 2

It is important to develop safety procedures that describe what to do in case of

Answer 2

accidents, injuries or contamination.

Question 3

laboratory design may be needed in order to prevent or reduce risks of cross-contamination

The laboratory must be designed to ensure proper ventilation throughout, with an active ventilation system and adequate space for circulation of people, laboratory carts and trolleys.

When designing a laboratory or organizing workf l ow, ensure that patients and patient samples do not have common pathways. Circulation paths should be designed in such a way that contact between the public and biological materials can occur only in the rooms where patient samples are collected. The reception desk where incoming patients register should be located as close as possible to the entry door.

Question 4

As a quality manager (or designated safety off i cer), it is necessary to:

** develop a complete and thorough description of basic safety rules** and organization, and ensure that personnel are trained in their specific duties when new activities or techniques are introduced into the laboratory;

know the basics of safety and biosafety management issues when working with chemicals and pathogens of moderate or low level of risk;

know how to perform an extensive risk assessment when developing new activities in the laboratory;

conduct laboratory safety audits.

The overall responsibility of managing the QC programme is usually assigned to the quality manager, who monitors and reviews all QC data on a regular basis. The recording of the QC data must be complete and easy to access.

Responsibilities will include assigning authority for the programme (usually to the quality manager) and supporting the corrective action measures that are indicated. It is essential that the laboratory director be fully informed about the results of all internal audits.
The quality manager is responsible for organizing and managing the laboratory internal audit programme. This includes setting a timeframe for the audits, choosing and training the auditors, and coordinating the process. The follow-up activities will also usually be the responsibility of the quality manager, and these include managing all corrective action efforts. The quality manager must be sure that laboratory management and the laboratory staff are fully informed about outcomes of the audit.
The commitment of laboratory management and the quality manager will be key to successfully establishing a process for internal audits.

Quality managers must convey to the laboratory staff the need for compliance with standards, whether international or national. The quality off i cer will explain the process for meeting standards, and will organize and prepare the laboratory for assessments.

Provide employees with orientation and training.
Keep track of employee records and make sure they are conf i dential.
Include policies relevant to personnel in the quality manual.

The quality manager is responsible for measuring the degree of customer satisfaction, using surveys, indicators and audits to take preventive and corrective action.

Quality managers assist in developing policies, planning and implementing the quality management system. They are usually responsible for many of the implementing and monitoring processes, and must communicate all aspects of the quality management system processes to the laboratory director or head of the laboratory.

The quality manager is the person most directly responsible for ensuring that the quality policies and procedures are carried out.

monitoring all aspects of the quality system;

ensuring staff are following quality policies and procedures;

regularly reviewing all records; for example, quality control and external quality assessment that are part of the quality system;

organizing internal audits and coordinating external audits;

investigating any def i ciencies identif i ed in the audit process;

informing management on all aspects of the quality system monitoring.