1Overview of analysed quality documents with their most important characteristics. http://ajlmonline.org/index.php/ajlm/article/downloadSuppFile/3/9
2aAnalysis of contents of national quality documents using the Quality System Essentials framework. http://ajlmonline.org/index.php/ajlm/article/downloadSuppFile/3/10
2a Analysis of contents of international quality documents using the Quality System Essentials framework. http://ajlmonline.org/index.php/ajlm/article/downloadSuppFile/3/11
Discussion There are a number of quality documents specific for clinical laboratories and for non-clinical laboratories. We compared the characteristics, suitability and applicability of these quality documents in view of the increasing efforts to introduce QM in laboratories. Clinical quality documents focus on both protecting the process, and the safety of the customer and the laboratory staff, whereas non-clinical documents aim primarily at protecting the safety and integrity of the analyses performed. Moreover, non-clinical quality documents are generally not focused on continuous improvement, an aspect that could be regarded as one of the major goals of a QMS. Clinical laboratory quality documents The fact that ISO 15189 includes a complete annex on ethics is exceptional when compared to all other quality documents. In clinical laboratory practice patient confidentiality and proper behaviour towards the patient are obvious ethical requirements. However, regulations regarding financial arrangements of the laboratory staff with external organisations or persons, or protection of the environment through correct waste-management are also ethical requirements. Therefore, we recommend including a paragraph containing specific ethical norms with regard to laboratory practice in every quality document. It was observed that the CLIA is highly comprehensive when compared to other clinical quality documents. This may be related to the fact that the CLIA is adapted to a national situation (with laboratories in the USA generally having abundant resources to facilitate good quality practice), whilst ISO 15189, as an international standard, has to maintain a certain level of generality to make it applicable in multiple countries that may have different standards of practice that are often determined by resource availability. The CLIA is more focused on protecting the process rather than the customers and personnel, making it different compared to other clinical quality documents. This may be a typical characteristic of a regulation that can have a narrower focus because other national regulations cover, for example, occupational safety (e.g. the USA 29 CFR part 1910 25): clinical laboratories in the USA following the CLIA need to comply with multiple other national regulations, whereas international standards and guidelines have to provide complete sets of requirements covering all aspects of laboratory practice. Non-clinical laboratory quality documents Most non-clinical laboratory quality documents are primarily process-focused. This may be the reason for the total absence of personnel safety requirements: the paragraphs of non-clinical quality documents shown in Table 2 in the QSE Facilities and Safety are all related to proper facilities and actions enabling safety of the process, not directed at the safety of personnel. This is illustrated by the requirement of the FDA-GLP in sub-part B, 58.29 (d): ‘personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems’.A characteristic found to be specific for non-clinical quality documents is the requirement to have a study plan or validated protocol in place besides SOPs. Often, non-clinical laboratories perform research in addition to routine procedures. This research cannot be standardised in SOPs. Notable, and probably related to the nature of test and calibration laboratories, is the low number of requirements aiming at the QSE Process Improvement. In clinical laboratories, processes consist mainly of routinely performed procedures. Continuous improvement is necessary to keep the performance of these procedures as efficient and effective as possible. In calibration laboratories, techniques should be performed with as little variance as possible, whereas variation in activities is inherent to the work of testing laboratories. Incorporating continuous improvement is therefore complicated, if not impossible. QSEs that are left uncovered in all but one of the non-clinical quality documents are Occurrence Management and Customer Service. Establishing procedures on customer service and occurrence management may be advisable in any environment. Only ISO 17025 contains requirements related to both QSEs, probably due to the incorporation of the highly customer-focused ISO 9001 standard during its development. 13, 26National versus international laboratory quality documents In many countries, international quality documents serve as the basis for national quality documents. Such adaption leads to documents that vary by country with regard to comprehensiveness. For example, the national guideline for clinical laboratories in the Netherlands is more extensive than the ISO 15189 standard. 27The same applies to the USA CLIA and FDA-GLP regulations. In contrast, the Chinese standard is less extensive than the ISO 15189, which makes it more feasible for laboratories in China to attain the standard. 28The required level of ISO 15189 was considered to be too high in relation to the resources available, with the consequence that few laboratories in China tried to become accredited. By making the national standards easier to achieve, Chinese laboratories were encouraged to implement QM leading to a substantial increase in accredited laboratories. 28On one hand some efforts on QM are better than no efforts at all, the concern however is the question in how far such simplified national standards can maintain adequate quality. This should be a topic of further research. Nevertheless, it is recommended to use national quality regulations, if available, as they are often more detailed and optimally adapted to the national situation, and take into account the available resources. The problem is that national standards are currently almost exclusively available in high-income countries. In the last decade, several middle-income countries, for example Thailand, Mexico and Argentina, have developed simplified national accreditation schemes based on international standards. 29,30,31,32 Recently, WHO-AFRO together with, among others, the USA Centers for Disease Control and Prevention (CDC) has launched an accreditation checklist based on CLSI GP26 and ISO 15189, which is tailor-made for implementation in clinical laboratories in LMIC, and has started the roll-out in sub-Saharan Africa. 7A strong point is that the absence of national regulations is taken into account in this initiative: the WHO-AFRO accreditation checklist contains lots of questions regarding laboratory safety that would otherwise need to be covered by national regulations on occupational safety. 11ISO 15189 only refers to national or regional regulations for safety requirements in such instances; these are absent in many countries. Study limitations A potential weakness of this study is that the framework for analysis was adapted from a clinical laboratory quality document. This means that this framework was tailor-made for clinical laboratory quality documents and thus biased towards a clinical laboratory QMS. Although we therefore were able to correctly identify gaps in non-clinical quality documents compared to clinical quality documents, we were not able to identify gaps in clinical laboratory quality documents as compared to non-clinical quality documents. Recommendations The type of laboratory and the resources available determine which document suits the practice of the laboratory best. National regulations are generally more detailed and tailor-made to the national laboratory system. International guidelines may be less detailed in order to remain applicable in multiple countries. Laboratories planning to establish a QMS need both a standard and a guideline. A standard provides no information on the reasons for implementation of the requirements, and standards are generally not measurable. The JCI document illustrates the need for more than a standard: in this document the requirements (standard) are supplemented with a description of the intent of the requirements to prevent misinterpretation (guideline). In addition, measurable elements help the laboratory to determine whether each requirement is complied with. It is important that documents are chosen which suit the practice of a laboratory best. Hence, clinical laboratories should choose a clinical laboratory standard, not the FDA-GLP, OECD-GLP, ISO 17025 or any other non-clinical laboratory document. Several suggestions and recommendations remain to developers of quality documents. It was observed that non-clinical quality documents generally lack provisions on occurrence management, customer service and process improvement; we recommend including requirements on these aspects. Ethics is also an element that applies to all types of organisations. Increasing attention to ethical behaviour is highly recommended. Acknowledgements We would like to thank Mirjam Engelberts for useful suggestions. Competing interests The authors declare that they have no financial or personal relationship(s), which may have inappropriately influenced them in writing this article. Authors’ contributions T.A.M.D. (Royal Tropical Institute) Datema was involved in designing the study, analysing the documents and writing of the article. L.O. (Royal Tropical Institute) was involved in designing and supervising the study and writing of the article. P.R.K. (Royal Tropical Institute) was involved in designing the study and writing of the article. 1.The W. 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