18Standards of direction, control, etc, of premises required

18 Standards of direction, control, etc, of premises required

Arrangements for categories GX and GY (1) For a category GX or GY pathology laboratory, a supervising pathologist or senior scientist must usually be present during normal working hours and available for telephone (or other electronic) consultation at other times. Arrangements for category B (2) For a category B pathology laboratory, the pathologist or senior scientist under whose direction and control pathology services are performed must: (a) be employed in the related category GX or GY laboratory; and (b) have qualifications and experience relevant to the laboratory’s operations; and (c) attend the laboratory, in accordance with subsections (3) and (4) (or arrange for the attendance of a scientist under his or her direction and control); and (d) be available for telephone (or other electronic) consultation when not personally attending the laboratory; and (e) monitor a system of electronic supervision of the quality of services performed. (3) The attendance requirement for paragraph (2) (c) is time amounting to, in a year: (a) if the electronic supervision is effected by way of online reports from the supervised laboratory to the related category GX or GY pathology laboratory—the equivalent of 10 full‑time days; or (b) otherwise—the equivalent of 50 full‑time days. (4) However, attendance at supervised training, or professional development, that is conducted in the related category GX or GY laboratory and is relevant to the supervision of the laboratory is taken to satisfy the laboratory attendance requirement: (a) if paragraph (3) (a) applies—to the extent of the time so spent, up to the equivalent of 5 full‑time days; and (b) if paragraph (3) (b) applies—to the extent of the time so spent, up to the equivalent of 20 full‑time days. (5) In addition: (a) externally administered quality assurance programs must be monitored by a pathologist or senior scientist employed at the related category GX or GY pathology laboratory who must endorse, in writing, the reports generated by the programs; and (b) an internal quality assurance system integrated between the laboratory and the related category GX or GY laboratory must be in place. Arrangements for category M (6) For a category M pathology laboratory, the supervising medical practitioner must: (a) usually be present when a pathology service is performed; and (b) be available for telephone (or other electronic) consultation when not present; and (c) have a working knowledge of the procedures for the pathology services performed and an involvement in the resolution of any problem encountered in performing those services; and (d) ensure that the only services performed are services appropriate for a category M laboratory. Arrangements for category S (7) For a category S pathology laboratory, the supervisor must: (a) usually be present when a pathology test is performed, unless, because of the training and experience of medical, scientific or technical support staff present, he or she need not be present; and (b) be available for telephone (or other electronic) consultation when not present; and (c) ensure that the only tests performed are tests appropriate for a category S laboratory.