Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)

Introduction

Since its introduction in 2003 ISO 15189 [1] has become the most important standard for accreditation of medical laboratories [2]. In some countries more general standards, such as ISO9001 [3] for quality systems or ISO17025 [4] for testing laboratories, are still used. In the US, medical laboratories are accredited for moderate or high-complexity laboratory testing by approved [5] organizations according to Clinical Laboratory Improvement Amendments (CLIA) rules [5]. The introduction of the latest third revision of ISO15189 in 2012, however, has given a new worldwide impulse to the use of this standard that has been particularly developed for the medical laboratories. The growing global recognition of ISO15189 also appears from the fact that some governments make it mandatory for medical laboratories or else insurance organizations (either public or private) demand it for reimbursement. In France, for instance, all medical laboratories must be accredited by Comité français d’accréditation (Cofrac) by 2020, a process that started in 2010. In Belgium it is mandatory for certain disciplines.

When a laboratory is accredited it has to be clear for all parties which particular services are part of that accreditation and which are not. This is defined as the scope of accreditation. According to regulations of the International Laboratory accreditation Cooperation (ILAC) and the European Co-operation for Accreditation (EA), laboratories must explicitly state on their reports which services are not under the scope of accreditation. Purpose of these regulations is clearly to prevent over-estimation of the accreditation of a laboratory by its customers. In accord with the multi-lateral agreement for recognition of accreditation between ILAC and EA member states, the national accreditation bodies (NAB) which are responsible for accreditation in their countries, must publish the scope of accreditation of every laboratory on their website. This allows the customers of the particular laboratories to check whether the service they seek is performed under accreditation or not.

Definition of scope

The scope of accreditation describes for which laboratory services the accreditation is granted. According to ILAC and EA regulations, the description of the scope may be either fixed or flexible. A fixed scope states every single test or service in every medical field in every type material. A flexible scope does not mention individual tests or services, but coherent groups of services within a medical field and with identical technical principle with provision of all applicable materials (or products or matrices such as serum, plasma, blood cultures etc).

Motivation for guidance

The European organization for accreditation EA has issued two relevant papers on scopes:

1. EA-2/15: EA requirements for the accreditation of flexible scopes [6].

2. EA-4/17: EA position paper on the description of scopes of accreditation of medical laboratories [7].

The EA describes that the scope can be either fixed or flexible and that “a flexible scope is preferred” [7]. EA encourages its member NABs to “provide this (flexible) service to their costumers” [6].

Although EA documents encourage flexible scopes and although laboratories as well as national societies for the different forms of laboratory medicine agree that flexible scopes are necessary for innovation, still in most countries accreditation is mostly under fixed scope (although they might refer to this as flexible). Although formally working with a fixed scope for some disciplines the scope may already have been defined in flexible terms, i.e., complete blood count (CBC) or identification and resistance testing of pathogens in feces. The reason for that seems that the NABs in spite of available EA guidance documents feel insecure about the border between flexible and too liberate.

EA regulations on scopes

Apart from the definitions on fixed and flexible scopes, the above mentioned EA documents on scopes contain some important regulations and suggestions that are important for our view on defining scopes:

• Laboratories should thrive for a scope that covers all services within each medical field of their service.

• For each medical field mentioned in the scope, the laboratory should be able to demonstrate its competence in all pre-examination, examination and post examination aspects as well as interpretation and patient/physician consultation.

• The scope should be described by the medical field, the examination type and the description of the materials associated with the service.

• Services that are not part of the scope must be specifically reported as “performed not under accreditation”.

The EA encourages that NABs consult the national scientific societies to formulate flexible scopes [7].

Choosing between fixed and flexible

To make a balanced choice between fixed or flexible it may be best to start with the purpose of the scope.

Reasons for a flexible scope

• A fixed scope puts an extra burden on intermittent innovation, as laboratories have to report every change to their list of services to the NAB, and the NAB has to weigh the need for extra audits.

• A flexible scope gives a better more readable insight into service levels that can be expected for customers of a laboratory.

Risk of flexible scopes

• When scopes are formulated too non-specific it can become unclear for the user of a laboratory service whether a particular service is either part or not of the scope of a particular laboratory.

• When scopes are formulated too non-specific, laboratories might provide services for which accreditation is suggested, but that are in fact outside its scope, without specifically mentioning this.

• NABs might select and send assessors with incomplete competence for all tests for which a laboratory seeks accreditation when the scope is formulated too non-specific.

Mitigating the risk of flexible scopes

• We propose that the scope exists in two layers: a general flexible format that is submitted to and published by the NAB together with issuing the certificates, and a detailed listing of examinations that is maintained by the accredited laboratory, intermittently communicated to the NAB and that is the subject of regular audits at a predetermined frequency.

• The general scope is then based on medical disciplines, and general test principles (we will expand on this further on in the paper at the hand of the Dutch example).

• The detailed listing is a list of all examinations with sufficient detail for the user of the results to define a test result unambiguously. The NAB will use this listing to check whether it does not contain any examinations that are not covered by the flexible listing. Thus a detailed table has to be available and kept up-to-date defining the measurand in terms of analite (e.g., sodium), sample type (e.g., whole heparinized blood), analytical matrix (e.g., plasma), analytical principle (direct potentiometry per kg solvent water, or indirect potentiometry per L volume).

• In the period between audits the laboratory shall report all changes in tests and diagnostic services that are provided by the laboratory to the NAB. This gives the NAB the opportunity to detect tests or services are performed that should be reported as outside the scope of accreditation.

• For accreditation, a laboratory is obliged to verify or validate all new or modified services according to ISO15189 (Section 5.5.1) [1]. This means that no services can be added to the scope without prior documented verification or validation and appropriate and successful IQC and EQC. As the laboratory process of validation is evaluated in every NAB audit, the risk of improper introduction of new tests is limited.

• The laboratory has to apply its standard procedures to the entire scope of activities in each of the accredited medical disciplines. If the laboratory chooses to report results as not under accreditation, than this must be unambiguously recognizable in all forms of reporting (either electronic or hard-copy, either cumulative or sample- or prescription-based reporting). Thus the NAB shall also audit the fraction of tests not under accreditation.

The Dutch approach towards flexible scopes: flexible, but not bendable

In the Netherlands traditionally medical laboratories are accredited to the CCKL guidelines for laboratory medicine. The first edition of this CCKL guideline dates from 1994 and was one of the predecessors of ISO 15189. Along with the preparation of the introduction of ISO15189 (2012) the Dutch scientific societies of the different fields worked together with Raad voor Accreditatie (RVA), the Dutch NAB to formulate a transition roadmap from CCKL towards ISO15189 accreditation. Along with the scientific societies for clinical chemistry, which includes hematology in The Netherlands (NVKC), medical microbiology (NVMM), immunology (NVVI), hospital pharmacy (NVZA), pathology (NVVP) and clinical genetic laboratory diagnostics (VGKL) also were involved: the Dutch society of laboratory technicians (NVMM), the Dutch federation of oral anticoagulant therapy (FNT), and the most important Dutch organizer for external quality assessment (SKML). As scopes in CCKL are, extremely flexible, and are not in concordance with EA-4/17, the scopes needed to be redefined for ISO15189 accreditation since concordance with EA 4-17 is essential for the NABs for their ISO 17011 accreditation as NAB.

Due to their history in extremely flexible CCKL scopes, The Netherlands seem to be the only country where flexible scopes for ISO15189 accreditation require more specificity, rather than loosening of current scopes. For that reason, the flexible scope definition for the transition from CCKL towards ISO15189 accreditation in The Netherlands holds a unique opportunity to introduce the flexible scope approach as originally intended and may be of value for other countries with no experience in flexible scopes.

At the beginning of the process, the main goals in the definition of scopes were different between the scientific societies and the NABs, and still needed to be made compatible with each other.

First it was established which criteria were important for all parties.

Important to the NAB were:

• Scopes must be specific enough to assure that services outside of the scope, cannot have the suggestion of being part of the scope.

• Scopes must be specific enough to determine the needed qualifications for an assessor to assess all possible tests/services that might be part of such scope. This is to prevent that an assessor could feel incompetent to assess the service, once at site during an audit.

It has to be clear within what limits innovation of new tests or services is allowed without the need for first establishing the competence of the laboratory on that particular combination of medical and technical field.

Important to the scientific societies were:

• Scopes must be flexible enough to allow innovation within a field that is already part of the scope without asking for scope extension.

• Scopes must be specific enough to distinguish between laboratories with different service level.

Both NAB and scientific societies immediately agreed that laboratories should not be allowed seeking accreditation for only a part of their service range. In other words; the accreditation scope of a laboratory should cover its complete service. This might not be easily achievable in countries where laboratory accreditation is at its beginning, but since in the Netherlands most medical laboratories already have a tradition in CCKL accreditation for their complete service array, this condition would add achievable customer protection against accreditation over-appreciation.

For both parties it was clear that services that are not part of the current scope of accreditation need prior notification to the NAB that then decides what inspection is required in order to broaden the scope to the new service. The discussion was about how to define what new services can be self-declared as part of the current scope, and what not. The scope needs to be flexible, without becoming bendable.

The EA-4/17 classification of medical field and type of examination may be used to specify scopes that accommodate the demands of both NAB and scientific societies, but needed extension to a more specific level. For instance, the medical field of hematology may be subdivided into hemocytometry, coagulation and transfusion medicine. When such more narrow medical fields are used in combination with technical field, then unique combinations of medical and technical field arise that meet the demands of both parties. For instance, for the field of coagulation, the technical fields of plasma coagulation, thromobocyte coagulation and qualitative DNA investigations can divide the field of coagulation in way that surely can determine whether an assessor can feel confident to assess, and is specific enough to prevent suggestion of scope for tests being clearly outside of it. For the scientific societies it is important that laboratories can have innovation within each of these combinations of medical and technical field without requesting change of scope at the NAB. As ISO15189 demand documented verification or validation of all new or modified services, a flexible scope does not endanger the quality of the provided services.

As all unique combinations of medical and technical field define the scope, new combinations have to be reported to the NAB, even when both the medical field and the technical field already exist in other combinations. For instance, when a laboratory already has endocrinology and LC-MS/MS as combination in its scope and also hemoglobinopathy research with HPLC, but not with LC-MS/MS, this laboratory cannot add hemoglobinopathy with LC-MS/MS to its scope without prior notification to the NAB.

Working out this concept of unique combinations of medical subfield and technical field.

The level of detail in technical field was decided to be at the level of technical principle, not at the level of individual techniques. For instance automated immuno-assays are considered as one technical principle. No difference is made between the different signal molecules that can be used to label antibodies or the detection techniques for those labels.

In the summer of 2013, all scientific societies active in medical laboratory services presented their translation of these principles to the RVA, the Dutch NAB as well as to each other.

Major findings of this inventory were:

• Most societies have come up with combinations of medical fields and technical principles that were comparable in their degree of specificity.

• Discussion between societies and NAB yielded quick consensus about the required level of specificity. With the different proposals on the table, discussion could be more practical and that facilitated the speed of the consensus process.

• Those societies that had formulated scopes that were more or less precise than the others, were able to rewrite their proposals to the agreed level of specificity within a very short time frame.

• Societies and NAB agreed that the established consensus outcome did both meet the EA-4/17 criteria and was practical enough for innovative medical laboratories.

• Societies and NAB decided to start using the newly defined scopes from 2014. The scopes as proposed and defined by the scientific societies function as “source scopes” since they contain all possible scope elements of the particular laboratory field. Individual laboratories can indicate whether they seek accreditation for a particular scope element.

• Where source scopes between societies had overlap discussion about mutual competence were decided by the question whether the particular scope element is in the training syllabus of the particular discipline or not. For countries with equivalence of standards the EC4 training syllabus for clinical chemistry and laboratory medicine may be used for the same purpose [8].

• It was agreed that flexible scoping is only possible for those source scopes and its elements that are covered by a staff laboratory member of the particular scientific society.

• When a laboratory seeks accreditation for an element that is not part of the flexible source scope of a discipline that is represented in the staff of the laboratory, then these elements can either be presented as fixed scope, or they have to be performed under responsibility of a special member of staff of the particular scientific society.

As an example a part of the source scope for clinical chemistry and hematology that is covered by the training syllabus of the Dutch society for clinical chemistry is depicted in Table 1 which is equivalent to that of the EC4 [8]. The complete source scope of all Dutch medical laboratory disciplines is continuously updated at the website of the RVA [9].

Lessons for other countries from the Dutch approach

The Dutch approach has showed that a practical approach based on the right intentions can yield a scope description that meets the criteria of EA-4/17 and the needs of laboratory professionals. The most important lessons are:

• Start with the formulation of the risks that should be mitigated by the outcome:

• Scopes must be specific enough to be sure that tests that are provided, but are not part of the scope, cannot have the suggestion of being part of the scope;

• Scopes must be specific enough to determine the needed qualifications for an assessor to assess all possible tests that might be part of such scope. This is to prevent that an assessor could not have the appropriate expertise;

• Scopes must be flexible enough to allow innovation within a field that is already part of the scope without asking for scope extension;

• Scopes must be specific enough to distinguish between laboratories with different service level;

• Laboratories must seek accreditation for a scopes that cover all of its services.

• The consensus process is fast and practical. Instead of bilateral “negotiations” between the NAB and the individual societies, it can be decided that the “raw” proposal of the scientific societies of all medical laboratory medicine disciplines is shared with both each other and the NAB. This will lead to mutual inspiration and allows testing of different approaches to the mutually agreed criteria. This can lead to a quick consensus on the optimal level of specificity.

EFLM recommendation

The Working Group A/ISO of the EFLM recommends that other countries follow the above mentioned risk-based approach to EA-4/17 on flexible scopes in an open dialogue between the NAB and the scientific societies of all medical laboratory disciplines along with all other parties involved. For laboratories, medical field or countries that have no or limited track record in accreditation, it may be necessary to make a gradual transition towards flexible scopes. Flexible scopes may be the privilege of those laboratories that have already demonstrated within a fixed scope that they have a validation/verification procedure that justifies the trust that comes with a flexible scope.

The risk-based approach is in line with the preventive action approach in ISO15189. Like all people, healthcare workers, including laboratory staff, do not like regulations without appreciating their purpose, but all do like to prevent risk. When quality regulations are based on an analysis to prevent risk, these regulations are much better accepted as they appeal to the intrinsic drive for doing the right things, the right way.