GUIDELINES FOR INTERLABORATORY QUALITY CONTROL IN ACCREDITED MEDICAL LABORATORIES

Transcription

1 GUIDELINES FOR INTERLABORATORY QUALITY CONTROL IN ACCREDITED MEDICAL LABORATORIES Approved By: Chief Executive Office: Mike Peet Senior Manager: Christinah Leballo Date of Approval: Date of Implementation: SANAS Page 1 of 6

2 CONTENTS: 1. Purpose and Scope 2. Definitions and References 3. Requirements for laboratories participating in Interlaboratory Quality Control 3.1 Types of Interlaboratory Proficiency Testing 3.2 Supplier Requirements 3.3 Material Transport 3.4 Organisation and Management 3.5 General Requirements ADDENDUM 1: Amendment Record SANAS Page 2 of 6

3 1. Purpose and Scope This document is to be used as a guideline for medical laboratories implementing interlaboratory proficiency testing (IPT), also referred to as Internal Quality Assessment (IQA), or Interlab Quality Control. All assessments are to be conducted according to the applicable ISO Standard, i.e. either ISO/IEC 17025:2005 or ISO Definitions and References SANAS PM SANAS A01 SANAS F29 SANAS F88 SANAS Policy Manual References, Acronyms and Definitions Generic Checklist for Accreditation of Medical Laboratories Accreditation Requirements for Medical Laboratories 3. Requirements for Laboratories Participating in IPT Any laboratory implementing an Interlab QC should conform to the relevant sections of ISO Guide 43, as well as the relevant sections of the ILAC document Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes ILAC-G13:2000. IPT is not intended to replace conventional EQA, which is considered an essential component of a laboratory s quality system. Rather, an IPT such as described in this guideline should only be used for tests where an appropriate EQA is not available. In addition, there may be instances where certain tests are analysed in such low volumes in laboratory that a formal EQA is not cost effective, and an IPT is more appropriate. Where it is not possible to perform an IPT, perhaps due to the lack of another laboratory performing the particular tests, then the laboratory should demonstrate traceability to a reference preparation or reference measurement procedure where possible; or if that is not possible, then acceptable repeatability should be well documented. 3.1 Types of Interlaboratory Proficiency Testing (IPT) The following types of IPT are defined by this guide : Secondary IQA (2-IQA). This refers to interlaboratory testing of randomly selected fresh or prepared in-house samples, or alternatively, assayed or unassayed manufactured samples or reference samples between two or more laboratories. The preparation methods for the 2-IQA samples should have been thoroughly validated and documented to demonstrate that stability is maintained throughout preparation, transport and storage Interlaboratory random sample exchange between two or more laboratories, of which one may be a reference laboratory, where no EQA program is available or otherwise affordable due to low-volume testing of specific tests. 3.2 Supplier Requirements If the material used is supplied by a manufacturer, the manufacturer should follow or conform to : i) ISO 9000; ii) DIN standards; iii) ANSI standards; iv) GMP; or v) be of proven international repute If the material used is manufactured or processed in-house, the laboratory should follow or conform to; i) standards as per ISO guide 43; or SANAS Page 3 of 6

4 ii) ILAC-G13: The material should be deemed suitable for testing with regard to: 3.3 Material Transport i) Each IPT sample should be uniquely identifiable; ii) There should be no patient identification on the sample container or in accompanying documentation; iii) Each sample should be stored and handled according to test-specific prescribed conditions; iv) Possible matrix effects should be documented for the participating laboratory's information and should be taken into account; v) Stability of the material is a pre-requisite for conducting IPT, and it should not be assumed that material sufficiently stable for internal QC will be suitable for use in an IPT scheme When the material is transported to the laboratory/ies the following should apply: i) The material should reach the laboratory within the stated time-frame; ii) The material should be transported within the specific temperature range; iii) The material should be transported in a manner which is safe to handlers and the general public; iv) There should be documented instructions for storage of the IPT material Specifications should be made on accompanying documentation of the analytical investigation/s to be undertaken on the IPT sample/s The accompanying documentation should specify whether a diagnostic opinion is required based on the specified investigation/s (where applicable). 3.4 Organisation and Management The laboratory undertaking the management of an IPT program should have demonstrable competence in the operation, management and control of Proficiency Tests All aspects of the operation of the IPT must be documented, including but not restricted to achievable standards of performance and suitable statistical analysis, taking cognizance of the different instruments and methods that may be used for the tests covered by the IPT The IPT program should be undertaken at a frequency that allows poor performance to be identified timeously so that such poor performance does not affect patient sample analysis The stated frequency should be validated and sustained throughout the period of running the IPT There should be a documented procedure in each participating laboratory for material processing and analysis of the IPT material There should be a secure procedure for capturing the IPT analyte results, whether manual or electronic The results should be archived and retrievable There should be an independent site available in or outside the laboratory for the IPT data analysis The individuals responsible for the data analysis should be competent to undertake the task, and be experienced in handling statistical data. SANAS Page 4 of 6

5 There should be a secure procedure for relaying these results to the independent site for data analysis Timelines should be set for the receipt of results by the independent site prior to data analysis The laboratory independent site should have a documented system detailing the process for data analysis The data analysis system should discriminate between laboratory instruments and methodologies (where applicable) The data analyses should be based on appropriate statistical methods and assumptions The data analysis system should report on levels of accuracy and precision based on consensus data or specific target values supplied by the manufacturer Access to the data analysis system should be secure The data should be archived for a specified time period Access to the data should be controlled Documented procedures should be available for the following: i) Report generation. ii) Appropriate action for poor performance in the IPT program There should be a documented instruction detailing the individual/s designated responsible for receiving and acting on the report. 3.5 General Requirements IPTs should conform to guidelines contained in ISO guide 43 and ILAC-G13:2000 for operating Proficiency Tests (PTs) (also known as External Quality Assessment (EQA) schemes) These requirements include,but are not restricted to the following: i) Sample matrix and stability requirements, especially with regard to stability during transportation ii) Turn-around times of reports should be stipulated and adhered to. iii) Documentation and management of the IPT system iv) Selection of an appropriate model for statistical evaluation of the laboratory results, taking the different instruments and methods into consideration. v) Stipulated and validated standards of performance for laboratories taking part in the IPT. vi) Competence and training in the set-up and operation of IPTs All materials used for IPTs should be deemed potentially infectious and treated accordingly. SANAS Page 5 of 6

6 ADDENDUM 1. AMENDMENT RECORD Proposed By: Section Change CEO Section 2 Changed QM to PM CEO Page 1 Changed to new logo & Front page QM Changed from R 74 (Requirement) to TG 74 (Technical Guidance) document. SANAS Page 6 of 6