ISO/TS 20658:2017 pdf download – Medical laboratories — Requirements for collection, transport, receipt, and handling of samples.
5.2 Laboratory test is ordered The organization shall provide information on how to order tests to all users of the services. There shall be instructions provided for the completion of a test request form (see 10.1 and Clause 11). 5.3 Sample request generation process The organization shall have procedures for the handling of requests for sample collection. This will include both written and verbal requests, in routine and emergency situations, in both paper and electronic formats. (See 11.2) 5.4 Process for providing instructions to patients The organization shall have procedures describing information that is given to and obtained from patients. The type of test requested will determine the need for fulfilment of specific requirements before sample collection (see 10.2). 5.5? Patient? identification? process The organization shall have policies and procedures for patient identification for both routine sample collection and sample collection in medical emergency situations (see 12.2 and 12.3). 5.6 Preparation for sample collection process The organization shall have policies and procedures for infection prevention and control (see Clause 8), informed consent (see 14.2), patient preparation and for recording any deviations. 5.7 Primary sample collection and labelling process The organization shall have procedures for the proper collection, labelling and handling of samples (see Clause 13, 14.3, 14.5, 14.6).
5.8 Preparation for transportation process The organization shall have procedures for samples that require special handling to maintain the integrity of the sample prior to and during transportation to the laboratory (see Clause 15). 5.9 Sample transport process The organization shall have procedures for packaging and transporting of samples (see Clause 16). Transportation of samples is subject to statutory and regulatory requirements. 5.10 Sample receipt process The organization shall have procedures for the receipt, assessment, processing and storage of samples. Sample reception procedures shall cover all sample types received by the facility (see Clause 17). 5.11 Process for preparing sample for examination The organization shall have procedures for preparing samples for examination. This process may occur at the collection facility or following transportation to the testing laboratory (see Clause 18).