CSA Z316.7-12:2017 pdf download.Primary sample collection facilities and medical laboratories
4.1 The pre-examination phase in clinical laboratory testing (shown in Figure 1) consists of all of the steps performed from the moment that a healthcare provider generates a test request to the time that the sample is ready to be tested.
The facility shall have documented procedures for its pre-examination activities to ensure the validity of examination results and to ensure patient safety. The documented procedures shall be available to all those performing pre-examination activities.
4.2 When changes (deviations, exclusions, or additions) to the documented procedures are required, these shall be recorded and included in all applicable documents and communicated to the appropriate personnel. The names of all personnel performing pre-examination activities (and other relevant information for identifying such personnel) shall be recorded in the appropriate records.
5 Quality management system
A quality management system is a systematic approach that allows the facility to describe, document,measure, and monitor the effectiveness of its work operations in order to meet the needs of its patients,healthcare providers, and other users as well as regulatory or accreditation requirements. A primary sample collection service facility shall have in place a quality management system that includes a quality manual and covers, but is not limited to, the following:
(a) management and personnel responsibilities;
(b) policies and/or procedures for all activities performed;
(C) document control (including control of quality and technical records);
(d) identification and management of non-conformities;
(e) handling of complaints;
(f) continual improvement;
(g) handling of corrective and preventive actions;
(h) internal audits;
(i) management review;
(j) quality indicators; and
(k) evaluation of suppliers.
Note: Quality management systerms are presented in, e.g., CAN/CSA-ISO 9001, ISO 15189, and CLSI GP26-A4. Annex A provides an adapted version of Iso 15189 quality management requirements suitable for use by facilities.
6.2.1 Patients shall be given clear and consistent information to enable them to understand the risks, benefits,and possible outcomes of collection procedures. Personnel shall properly introduce themselves to the patient and obtain consent before proceeding with the collection.
Note: Consent may be implied. See Clause 11.6 for consent-related requirements.
6.2.2 Jargon-free (plain) language shall be used to convey information at a level that the patient can understand in order to facilitate informed consent. When possible, language barriers shall be resolved to ensure that the information is clearly understood by the patient. Written instructions (as well as graphic educational materials designed for patients) shall be used to complement patient communication when deemed necessary. Consideration should also be made for translation, depending on local population needs.CSA Z316.7-12 pdf download.