CSA Z316 7-2012 Primary sample collection facilities and medical laboratories - Patient safety and quality of care - Requirements for collecting transporting and storing samples (F.pdf

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1、Z316.7-12Primary sample collection facilities and medical laboratories Patient safety and quality of care Requirements for collecting, transporting, and storing samplesLegal Notice for StandardsCanadian Standards Association (operating as “CSA Group”) develops standards through a consensus standards

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16、ation des chantillons dans le domaine de la biologie mdicale, 4th ed. (2010).This Standard was prepared by the Subcommittee on Specimen Procurement, under the jurisdiction of the Technical Committee on Medical Laboratory Quality Systems and the Strategic Steering Committee on Health Care Technology,

17、 and has been formally approved by the Technical Committee.Notes: (1) Use of the singular does not exclude the plural (and vice versa) when the sense allows.(2) Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibili

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22、ardsactivities.csa.ca.(5) This Standard is subject to periodic review, and suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following information to inquiriescsagroup.org and include “Proposal for change” in the subject l

23、ine:(a) Standard designation (number);(b) relevant clause, table, and/or figure number;(c) wording of the proposed change; and(d) rationale for the change. 2012 CSA GroupPrimary sample collection facilities and medical laboratories Patient safety and quality of care Requirements forcollecting, trans

24、porting, and storing samplesDecember 2012 1Z316.7-12Primary sample collection facilities and medical laboratories Patient safety and quality of care Requirements for collecting, transporting, and storing samples0Introduction0.1The pre-examination phase in clinical laboratory testing is of utmost imp

25、ortance and needs to be well understood as it includes the initial stages of producing test results that drive relevant and informed clinical decisions. The pre-examination phase consists of all of the steps performed from the moment a healthcare provider generates a test request to the time that th

26、e sample is ready to be tested. Errors can occur in any of the numerous steps in this process, including collecting blood from the wrong patient, mislabelling the sample, or inappropriately storing the sample, which can lead to erroneous diagnosis and treatment of the patient. These types of errors

27、can go unrecognized if pre-examination policies and procedures are not properly established, standardized, and followed. This Standard specifies quality requirements for sample collection, transport, and storage to ensure that a high level of patient safety and quality of care is achieved and to aid

28、 in the prevention of these errors.0.2This Standard may be used as a stand-alone document for facilities performing pre-examination activities or with ISO 15189 (see Clause 5) for facilities that also perform examination and post-examination activities.0.3The requirements of this Standard apply to f

29、acilities performing pre-examination activities. Facilities include, but are not limited to, medical laboratories performing pre-examination activities and primary sample collection services. Primary sample collection services include, but are not limited to, any organization or person that collects

30、 primary samples, e.g., hospitals and associated collection centres, bedside collections within hospital centres or other healthcare facilities, private and public collection service organizations, doctors offices, and home collections. When the term “facility” is used to designate a medical laborat

31、ory, only pre-examination activities are included in the scope of the requirements of this Standard.Note: It is possible that national, provincial/territorial, or local requirements will apply.1Scope1.1This Standard establishes quality requirements for sample collection, transport, and storage to en

32、sure that patient safety and quality of care are at the forefront of the pre-examination process of laboratory testing.Z316.7-12 2012 CSA Group2 December 20121.2Specific procedures for each step of the pre-examination process of laboratory testing are beyond the scope of this Standard and should be

33、performed in accordance with recognized standards.1.3Although the requirements of this Standard also apply to point-of-care sample collection, point-of-care testing itself is beyond the scope of this Standard. CAN/CSA-Z22870 specifies requirements for such testing.1.4In this Standard, “shall” is use

34、d to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the

35、 standard.Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.Notes to tables and figures are considered part of the table or figure and may be written as requ

36、irements.Annexes are designated normative (mandatory) or informative (nonmandatory) to define their application.2 Reference publicationsThis Standard refers to the following publications, and where such reference is made, it shall be to the edition listed below, including all amendments published th

37、ereto.Note: See also Annex K.CSA GroupCAN/CSA-ISO 9001-08Quality management systems RequirementsCAN/CSA-Z902-10Blood and blood componentsCAN/CSA-Z22870-07Point-of-care testing (POCT) Requirements for quality and competenceCLSI (Clinical and Laboratory Standards Institute)GP26-A4 (2011)Quality Manage

38、ment System: A Model for Laboratory Services; Approved GuidelineMM13-A (2006)Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved GuidelineISO (International Organization for Standardization)15189:2007Medical laboratories Particular requirements for quality an

39、d competence3 DefinitionsThe following definitions shall apply in this Standard:Capillary puncture a procedure that involves collection of blood from capillaries following puncture of the skin. 2012 CSA GroupPrimary sample collection facilities and medical laboratories Patient safety and quality of

40、care Requirements forcollecting, transporting, and storing samplesDecember 2012 3Cleaning 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

41、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. Not

42、e: 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 13 years of age or younger.Personal protective equipment (PPE) materials used to form a barrier to prevent co

43、ntamination 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

44、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 instea

45、d 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 prim

46、ary 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, doctors offices, and home collections.Sample (aliquot) a portion removed from a pri

47、mary 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.Sa

48、mple 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

49、 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 maintai