CSA Z316.7-12 pdf download – Primary sample collection facilities and medical laboratories — Patient safety and quality of care — Requirements for collecting, transporting, and storing samples.
Cleaning — physical removal of microscopic or visible dirt, secretions, excretions, and other organic matter. Disinfection — the process of inactivating most micro-organisms, not including spores, on inert surfaces. Facility — a medical laboratory performing pre-examination activities or a primary sample collection service. Hand hygiene — hygiene involving either hand washing with soap and water or the use of alcohol-based hand sanitizers. Patient — any individual receiving health care in an inpatient or outpatient setting. Note: This includes individuals commonly referred to as “patients”, “residents”, “clients”, etc. Pediatric patient — any individual receiving health care, ranging from newborns to children who are 1 3 years of age or younger. Personal protective equipment (PPE) — materials used to form a barrier to prevent contamination of a person by chemical or biological substances. Note: These can include, but are not limited to, lab coats, gowns, gloves, face shields, and goggles. Phlebotomy — incision of a vein or capillary to collect blood. Pre-examination activities — steps starting with a sample request, followed by preparation of the patient, collection of the primary sample, transport of the sample to and within a laboratory, accessioning of the sample, stabilization of the sample, storage of the sample, and ending when the examination activities begin. Note: The term “preanalytical phase” is often used instead of “pre-examination activities”. Primary sample (specimen) — a sample collected from or by a patient that is still in its original collection container and is to be used for examination purposes. See also Sample (aliquot). Primary sample collection service — any organization or person that collects primary samples, including, but not limited to, hospital and associated collection centres, bedside collections within hospital centres or other healthcare facilities, private and public collection service organizations, doctor’s offices, and home collections.
Sample (aliquot) — a portion removed from a primary sample that is used for examination purposes. Note: The term “sample” is used in this Standard to include both the primary sample (specimen) and sample (aliquot) in situations such as handling, transport, and storage. Sample collection — the recovery process by which a primary sample is obtained. Sample integrity — unimpaired composition of a sample submitted for analysis. Sample request (test request) — a request originating from a qualified healthcare provider for samples to be collected for medical laboratory testing. Note: The terms “test ordering” and “requisition” are also used. Stabilization — a method or steps undertaken after sample collection and before testing to limit or prevent degradation of the analyte(s) to be tested in the sample. Sterilization — elimination or destruction of most viable forms of microbial life, including bacterial or fungal spores, accomplished by physical or chemical processes. Storage — the process of maintaining samples under appropriately controlled conditions. Transport — the process of moving samples from one location to another under appropriately controlled conditions.
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 systems 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.CSA Z316.7-12 pdf download.
