Standard 1 — Staffing and supervision

S1.1 There shall be sufficient professional and support staff with adequate training and experience to supervise and conduct the work of the laboratory.

S1.2 The designated person in charge, under whose direction and control the accredited pathology laboratory operates must:

a) determine the range of tests provided, their methods and procedures
b) approve and be responsible for operational practices and staffing of the laboratory (including staff training)
c) ensure regular review of the laboratory’s quality systems, proficiency testing data, laboratory reports and discussion of all aspects of the laboratory’s performance with the scientific staff
d) ensure appropriate consultation on medical and scientific issues (see Standard 2 for further information)
e) ensure that the procedures used and the tests performed are within the scope of the education, training, continuing professional development and experience of the individual staff, and be able to demonstrate (by appropriate documentation) that this is the case
f) ensure that there is continuity of overall supervision in situations where the supervision is provided by more than one person
g) ensure that work performed at the laboratory outside normal working hours is carried out only by scientific or technical staff with appropriate training and experience, approved by the supervising pathologist or senior scientist.

S1.3 In a Category GX or GY laboratory the supervising pathologist(s) or senior scientist(s) must be present during normal working hours of the laboratory. Where a Category GX or GY laboratory is supervised by a senior scientist there must also be a pathologist present during normal working hours of the laboratory.

Commentary on staffing and supervision

C1.1 The following commentary discusses staffing and supervision for each of the five laboratory categories. Further information on consultation can be found in Standard 2.

Categories GX and GY

C1.2 The supervising pathologist(s) or senior scientist(s) must be present during normal working hours of the laboratory. For the purposes of this document, "must be present" includes being contactable for consultation but not being in physical attendance at the Category GX/GY laboratory:
(a) to provide supervisory visits to related Category B laboratories within the same organisation as the Category GX/GY laboratory
(b) for bona fide absences for professional purposes or due to illness or personal necessity for up to seven consecutive work days.Top of page

Category B

C1.3 The designated supervising pathologist or senior scientist from the Category GX or GY laboratory, under whose direction and control the Category B laboratory operates, shall:
a) be responsible for ensuring control over the monitoring and rendering of services, including oversight of supervision
b) be responsible for ensuring that the laboratory computer system fulfils its function in monitoring and rendering of services.
c) review and countersign proficiency testing results
d) be available for telephone consultation or equivalent when not personally in attendance at the laboratory.

C1.4 Onsite staff at a Category B laboratory shall include a supervising scientist with appropriate qualifications and a minimum of 2 years supervised experience relevant to the laboratory’s operation. The onsite supervising scientist* must be present at the laboratory during normal working hours.

C1.5 The Category B laboratory shall be an integral part of, or maintain operational systems that are consistent with, the quality system of the Category GX or GY laboratory.

C1.6 Where the Category B laboratory computer system is an integral part of, or sufficiently compatible with, the Category GX or GY laboratory computer system to allow control over the monitoring and rendering of services, the following conditions apply for the purposes of electronic supervision:
a) supervising pathologists, pathologists or scientists from the Category GX or GY laboratory must spend at least 10 full-time-equivalent (FTE) days per year at the branch laboratory
b) at least one day of these FTE visits must be from a supervising pathologist or pathologist
c) time that scientists or technicians from the Category B laboratory spend in supervised training or professional development in the Category GX or GY laboratory (or at an appropriate training location) may be offset against the aforementioned supervisory requirements, up to a maximum of 5 days per year
d) where there is documented teleconferencing and videoconferencing management of the Category B laboratory, time spent in such activities may be offset against the aforementioned supervisory requirements, up to a maximum of 2 days per year

C1.7 Where the Category B laboratory computer system is not an integral part of, or is not sufficiently compatible with, the Category GX or GY laboratory computer system to allow control over the monitoring and rendering of services, the following conditions apply for the purposes of electronic supervision:
a) supervising pathologists, pathologists or scientists from the Category GX or GY laboratory must spend no less than 50 FTE days per year at the branch laboratory
b) time that scientists from the Category B laboratory spend in supervised training or professional development in the Category GX or GY laboratory (or at an appropriate training location) may be offset against the aforementioned supervisory requirements, up to a maximum of 20 days per year.

C1.8 Whilst recruiting a supervising scientist, in the event of exceptional circumstances, a person who is a scientific officer of more than 1 but less than 2 years experience or a technical officer with at least 10 years experience relevant to the work of the specified laboratory, may be deemed to supervise a category B laboratory, provided:
a) the supervising pathologists, pathologists or scientists from the GX or GY laboratory must spend no less than 50 FTE days per year and
b) the officer must spend at least 10 FTE days per year in supervised training or professional development in the Category GX or GY laboratory.Top of page

Category M

C1.9 The medical practitioner shall:
a) be responsible for the proper performance of tests
b) have a working knowledge of each test procedure
c) review and countersign proficiency testing results
d) be involved in the resolution of problems encountered with the laboratory work
e) be responsible for the implementation of the test results.

C1.10 The medical practitioner will usually be present while the testing is being carried out.

Category S

C1.11 The supervisor of a Category S laboratory must be present at all times that tests are performed unless there are medical, scientific or technical support staff, approved by the supervisor, whose qualifications and experience are adequate for the work performed at the laboratory. Where such support staff are available, the supervisor shall maintain regular contact with the laboratory and be available for consultation at all times.

C1.12 The supervisor of a Category S laboratory shall review and countersign proficiency testing results.

* Where more than one scientist provides the supervision, a designated scientist must ensure the continuity of overall onsite scientific supervision