Summary of clause 4 General requirements

Requirements

Carry out laboratory activities impartially

Structure and manage laboratory to safeguard impartiality

Commit to carrying out activities impartially

Assume responsibility for its activities

Prevent pressures from compromising the impartiality of laboratory activities

Monitor activities and relationships

Include relationships with personnel

Eliminate or minimize the effect of any threat

Be able to demonstrate how a threat is mitigated

Assume responsibility for managing all patient-related information

Ensure that patient information management includes respect for privacy

Inform the patient (or user) in advance of the information

Treat all information as confidential

Inform the patient of the confidential information that will be disclosed

Maintain the confidentiality of patient information obtained from sources other than the patient

Do not disclose the identity of the information source

Do not disclose the identity of the information source to the patient

Maintain the confidentiality of all information obtained through laboratory activities

Ensure that patient well-being, safety, and respect for patient rights are prioritized

Establish and implement the process seize opportunities

Establish and implement the process make public information available

Establish and implement the process review periodically examinations offered by the laboratory

Establish and implement the process communicate incidents to stakeholders

Establish and implement the process handle patients, samples, and anatomical specimens

Establish and implement the process obtain formal consent

Establish and implement the process maintain the availability of all patient samples

Establish and implement the process for communicating information to the patient or a healthcare provider

Establish and implement the process respect patient rights

Manage patient rights

Declartion of no conflict of interest

Confidentiality agreement

Patient needs and expactations