Document ID: chunk:federal_register_of_legislation:F2022C00276:clause:1_12
Version: federal_register_of_legislation:F2022C00276
Segment Type: clause
Provision Reference: sch 1 cl 12
Character Range: 25912–27184

12  Physical assessment
 (1) A physical assessment must be conducted in relation to a donor of HCT materials (other than a donor of HCT materials used exclusively for plasma fractionation in the manufacture of an export only medicine) as follows:
 (a) in the case of a living donor (other than a living donor of human musculoskeletal tissue only)—at the time of the collection of the HCT materials; or
 (b) in the case of a living donor of human musculoskeletal tissue only—within 30 days before or 30 days after the collection of the tissue; or
 (c) in the case of a deceased donor—before the collection of the HCT materials.
 (2) A physical assessment must:
 (a) include a clinical inspection of any physical features or characteristics of a donor (such as an abrasion, laceration, bruise, haematoma, fracture, tattoo, piercing, scar, skin lesion, or surgical incision) that may indicate that the donor poses a risk of infectious disease transmission; and
 (b) be conducted by a person who is:
 (i) appropriately qualified and trained; and
 (ii) an employee of, or under a contract with, a person engaged in the collection of HCT materials or the manufacture of HCT products; and
 (c) demonstrate that the donor does not pose a risk of infectious disease transmission.