Introduction

One of the cornerstones in the Iranian health system policy is providing equitable access to quality and timely laboratory services all around the country. The Reference Health Laboratory (RHL) is a directorate general in Ministry of Health (MoH), responsible for making policies and plans for strengthening the health laboratory system in Iran.

According to International Health Regulation (IHR) 2007, all WHO members are required to develop policies to strengthen the capabilities of clinical laboratories in their own country [1]. To this purpose and in accordance with national health policies, RHL devised a long-term strategy to implement quality management system in all clinical laboratories across the country and to establish a national laboratory accreditation system.

At the first step in 2007, a “National Laboratory Standard” was composed by RHL’s expert committees based on the international standard ISO 15189:2007, the latest edition at that time, which had been recognized and widely used by many countries as the main standard for clinical laboratories. However, RHL committees substantially modified the international standard based on the situation and limitations in the Iranian laboratory system, yielded by a comprehensive situation analysis performed on more than 5000 laboratories in different provinces, working in different public and private sectors with different ranges of activities and capabilities and different levels of quality performance [2]. Considering our laboratories’ weak points, some important technical details as well as safety requirements were added from WHO documents and CLSI guidelines. On the other hand, some unfamiliar management requirements of the international standard were omitted, knowing that this might compromise the credibility of the laboratory data in an international perspective. This national standard mainly focused on seven essential sections that covered almost 60 % of the requirements of the international standard [3]. These sections included Laboratory environment and facilities; Personnel management and training, Laboratory Equipment management, Documentation, Examination by referral laboratories and requirements of referring specimen, Biosafety requirements in medical laboratories and Waste management.

Finally, a completely modified version of ISO 15189 was compiled in September 2007, as the first edition of Iranian National Laboratory Standard. It was officially announced as the minimum quality requirements mandatory for all clinical laboratories to follow; yet, the ultimate goal was to upgrade the national standard and make it more compatible with the international one.

It is noteworthy to mention that shortly after the standard was decreed, RHL devised and launched a comprehensive plan to build the required capacities for implementing the laboratory standard. To do that, a lot of effort was made but there were many challenges on the way. These challenges are completely described in an article titled “Challenges of Implementing Iranian National Laboratory Standards” by Safadel et al. [4]. Establishing a national accreditation system for clinical laboratories was the next step. Therefore, after a short while a related checklist was compiled as a tool for assessing the implementation of the standard requirements, and a pool of trained laboratory assessors were organized to inspect the laboratories. Concurrently, the laboratories had the option to implement a set of more stringent requirements quite close to ISO 15189 voluntarily and receive a “Quality Award.”

For the first time in June 2011, and also 5 years later in June 2016, the renewal of laboratory licenses was conditioned on the compliance of the laboratories performance with the national standard requirements, which was assessed through on-site inspection. The information gathered from countrywide laboratories’ license renewal reports in 2016 revealed that more than 70 % of the laboratories had successfully implemented almost 75 % of the requirements of the national standard. The remaining 30 % who failed to comply with at least three-fourths of the requirements were mostly district health laboratories with limited range of activities, basic facilities and few staff without strong motives to improve their performance. Of course, a deadline was set for them and the legal licenses of those who didn’t manage to implement the minimum requirements was canceled. With regard to this progress and considering the fact that standards are to be reviewed and revised periodically, in 2017, ten years after publishing the first edition, RHL decided to compile the second edition of the Iranian national laboratory standard and make it more compatible with the ISO 15189:2012, the latest edition of the international standard. It took more than one year for RHL expert committees to compile the second edition of Iranian national laboratory standard. This new edition was officially decreed by the Ministry of Health as mandatory requirements to be followed by all clinical laboratories.

We believe describing the steps that were taken for development of our national standard based on an international standard might inspire policy makers in other countries to try this approach to compile their own national laboratory standards. Moreover, comparing the context of the ISO 15189 to Iranian national laboratory standard and defining the modifications that were made to make it more apprehensible would give a rough guide as to which parts of the ISO 15189 might need more explanation and the references the laboratory staff could use for further information.

Methods

To upgrade the Iranian national laboratory standard, initially RHL considered publishing the translated version of the international standard ISO 15189:2012 as Iranian mandatory laboratory standard. But, taking into account the sophistication and intricacy of the text of the international standard, we were concerned that laboratories might have trouble understanding and implementing it properly. Some clauses and subclauses needed clarification or giving examples to be more comprehensible for the laboratorians. Furthermore, we believed that it would be beneficial to add some explanation on how to implement the requirements in the laboratories. For these reasons, the final decision was not to introduce the translated ISO 15189:2012 as mandatory laboratory standard; instead, we planned to compose a more comprehensive, detail oriented and easily understandable national standard that fully complies with the structure and content of the ISO 15189:2012. To put emphasis on necessity of compliance with the national laboratory regulations, we also decided to include some essential regulatory requirements and bylaws to the relevant sections.

First, several specialized committees were organized by RHL. The committees were assigned to review the international standard ISO 15189:2012 thoroughly. Each and every clause and subclause was meticulously evaluated and discussed by committee members and some sections were highlighted as parts of the international standard which needed more explanations. In the next step, the committees did a comprehensive literature review for each section. Many credible references such as WHO documents and CLSI standards were studied carefully, and some details or examples were added to certain parts of the international standard to clarify the context; while the structure and format of the ISO 15189 (encompassing fifteen management requirements as well as ten technical requirements) were carefully maintained. Afterward, some important points from national guidelines, regulations and bylaws were added to the related clauses where necessary. In this manner, the first draft of the new edition of Iranian national laboratory standard was developed.

In the next step, the draft was shared with all clinical laboratory scientific societies to be reviewed by laboratory quality experts. The feedbacks were gathered, analyzed and applied. Then the revised draft was sent to a broader spectrum of laboratory stakeholders consisting of experts in more than 90 organizations including medical universities, referral laboratories, selected laboratories in public and private sectors, related authorities in MoH, health insurance companies and laboratory equipment providers. Then again, the recommendations and comments were gathered, assessed and discussed by RHL expert committee. Some were rejected while some were accepted and applied.

All in all, after more than a year the second edition of the Iranian national laboratory standard was compiled and officially decreed by health deputy minister in late May 2018 as the minimum quality requirements mandatory for clinical laboratories all around the country.

Results

The content of the revised national standard is quite close to the international standard as well, except for some parts where a few explanations, additional details, examples and regulatory requirements are added.

Table 1 shows the clauses that have been completed or undergone some changes.

Table 1 Comparing the Iranian national laboratory standard with ISO 15189:2012
Full size table

Discussions

The initiatives to strengthen laboratories in low- and middle-income countries (LMIC) have evolved rapidly since 2008 especially in the clinical diagnostic laboratory sector. While the efforts to improve health in LMIC initially focused on treatment and care, the focus has now broadened to the quality of laboratory diagnosis. Stakeholders encourage countries to develop standards, guidelines and regulations to improve the quality of laboratory testing and meet the Millennium Development Goals to achieve better health [5,6,7,8]. Standards define the requirements for quality performance and are used as criteria for assessing and auditing organizations. National authority for standardization can either develop national standards or adopt international standards with or without modifications [9].

The ISO 9001 standard addresses general quality management system requirements that apply to laboratories as well as other organizations. Two ISO standards, ISO 15189 and ISO/IEC 17025, are specific to laboratories. Also, there is ISO 15195 which refers to specific aspects of calibration laboratories in the field of laboratory medicine. These laboratories are usually denoted as “reference measurement laboratories.” There are also some other standards organizations and many examples of national and international laboratory standards [10].

Establishing an internationally recognized clinical laboratory standard such as ISO 15189 has many advantages. This standard was developed by a large group of experts from different countries and covers almost all essential aspects of laboratory activities that affect quality laboratory performance. Moreover, many regional and international accreditation organizations, such as the International Laboratory Accreditation Cooperation (ILAC), the Inter-American Accreditation Cooperation (IAAC), the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the European Cooperation for Accreditation (EA), recommend that ISO 15189:2012 be used for accreditation of clinical laboratories [5]. So, there are many cases where an ISO standard is adopted by national bodies without any changes, or a translation of an international standard such as ISO 15189 is used and wherever necessary just refers to complementary documents. In some instances, a regional standard such as CEN in Europe is adopted to a national standard without changes. Therefore, endorsing a well-known international or regional standard would be very plausible.

However, there are some setbacks in establishing an international standard at national level. Firstly, generality is inevitable in international standards so as to fit in different situations. The international standards are almost a general list of requirements for quality laboratory practice. These standards do not contain explanations on how to implement the requirements or comply with them. Secondly, international standards naturally do not consider local condition in different countries. In case that the standard requirements are to be mandatory and enforced by authorities to be implemented in clinical laboratories in a country, it should be adjusted and tailored to the laboratories’ needs, situations and other related regulations in that country. Therefore, countries are encouraged to develop their own national standards [5].

Many countries have the experience of developing their national laboratory standards that optimally adapted to their condition. Some of these quality documents are very comprehensive and detail oriented while others are brief. For example, the national guideline for clinical laboratories in the Netherlands is broader in scope than the international standard ISO 15189 [11]. The 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 [12].

In the last decade, several middle-income countries, for example, Thailand, Mexico and Argentina, have developed simplified national accreditation schemes based on international standards [13,14,15,16]. Kusum and Silva argued that international standards are quite extensive and often very resource-intensive and in Thailand, only a few leading laboratories could conform to these standards, while a majority get discouraged to even attempt to meet the exhaustive list of requirements which could lead to an “all or none” situation [17]. In India, the Quality Council of India has created “Essential Standards for Medical Laboratories.” The national Indian standards were created by using a multi-stakeholder approach and balanced the needs of rural and urban settings [18, 19] so it could be applied to all medical testing facilities, regardless of size, capacity, sophistication, or location. The Indian standards reflect internationally accepted processes and procedures for clinical laboratories to consistently produce accurate results [20].

In Iran, we decided to develop our own national standard based on the international standard ISO 15189, i.e., instead of using word-for-word translation of the international standard, we used it as a base or template for compiling the national standard. To become more applicable, we believe that there should be more information, explanations, justification and interpretation describing why and how to implement the standard requirements. As for the first edition of the National Iranian Laboratory standard in 2007, we had to make substantial changes to the international standard because it was not feasible to enforce all the requirements of the ISO 15189 in clinical laboratories in the country, taking into account the situation and limitations at that time. So, the first edition of the national standard was mostly focused on certain clauses of the “Technical Requirements” and only composed of seven main chapters: “Laboratory environment and facilities,” “Personnel management and training,” “Laboratory Equipment management,” “Documentation,” “Examination by referral laboratories and requirements of referring specimen,” “Biosafety requirements in medical laboratories” and “Waste management” and encompassed only 60 % of the ISO 15189:2007 the latest version at that time [2].

In 2017 when we decided to develop the second edition of the National Iranian Laboratory standard, the situation was different because in a ten-year period of time we managed to establish a stepwise plan to build the required capacities for implementation of the standard requirements and evaluation of the clinical laboratories’ performances nationwide. Considering the progresses the laboratories made in implementing the first edition, we decided to upgrade the national standard to become much more compatible with the international standard. Therefore, the second edition of our national standard, despite the previous version, contained all 25 clauses of the ISO 15189:2012. However, we added some explanations and interpretations to make it more user friendly and facilitate its application, e.g., under “Quality Management System,” “Documentation” and “Control of Records,” the concept of quality management system and the reasons why developing and keeping documents and records are beneficial are explained. The clause; “Accommodation and environmental conditions” needed a lot of details to guide the laboratories on how to establish an optimal environment for various laboratory activities. In “Examination Processes,” and “Ensuring Quality of Examination Results,” general principles of validation and verification of laboratory methods as well as quality control essentials for quantitative and qualitative methods were described comprehensively.

Requirements regarding “Pre-examination Processes,” specimen management, “Examination by Referral Laboratories” and “Service agreements,” are of significant importance for us since access to many laboratory services throughout the country is provided by various laboratory networks; hence, the requirements of these clauses were meticulously defined.

Furthermore, as RHL is responsible for making policies and determining the minimum quality requirements mandatory to be followed by all clinical laboratories, some related regulatory requirements were added to the relevant clauses. For instance, under the “Organization and Management Responsibility” the responsibilities of laboratory directors that listed in “Governmental Laboratory Regulations” were inserted and under “Personnel” training requirements and criteria for competence assessment were mentioned. Some regulatory requirements were also added to “Reporting and Release of results” and “Evaluation and Audit” sections.

To assist the laboratories to settle the requirements, many practical points were included in “External Services and Supplies” and “Laboratory Equipment, Reagents and Consumables.”

“Identification and Control of Nonconformities” was also one of those clauses that needed further explanation. We also clarified the concept of “Quality Indicators” by giving some examples and justified the importance of determining and measuring the indicators to assess the effectiveness of the activities.

It should be mentioned that since ISO 15189:2012 does not contain safety requirements and only refers to national or regional regulations, we decided to upgrade the guidelines on safety and waste management that had been already developed and added many details from WHO and enclose it to the national standard as an annex [21,22,23]. Needless to mention, safety requirements will be included in our assessment checklist.

Conclusions

It is feasible to develop a national laboratory standard with the same structure and content of an internationally recognized standard such as ISO 15189 while adapting the subjects to become more comprehensible and applicable for national purposes. As discussed earlier, there are advantages in compiling and establishing national standard. However, there are still some drawbacks in implementing the same standard in laboratories in different sectors throughout the country with various ranges of activities and capabilities and different kinds of limitations in different provinces of the country. It takes a definite strategy and detailed action plan to implement national standard in a stepwise manner. In some circumstances, the laboratories should be allowed or even required to adapt the national standard to their local realities. Yet, in RHL we have been planning to overcome our challenges but still could not manage to conquer all the setbacks.

The next step ahead us is compiling a related checklist to evaluate the extent of compliance to the national standard by on-site assessment of the laboratories. Taking into account the probable risks of failures in fulfilling different requirements, we believe that the importance of the requirements in different sections are not the same so we are planning to prioritize the requirements in this checklist by giving different scores to the requirements. The further step is to determine a certain score as minimum acceptable level to extend laboratory licenses. Concurrently, RHL is going to arrange cascading training courses throughout the country for laboratory assessors who are responsible for inspection of laboratories as well as laboratory directors and technical staff. Considering the experience, we gained during this past ten years and since the first author of this article became a member of the ISO/TC 212/WG1 e-committee, another step would be to try to influence the development of the next edition of ISO 15189 standard.

It is noteworthy that there is always this opportunity for laboratories to voluntarily seek accreditation for ISO 15189:2012. Having considered that the requirements of ISO 15189:2012 are entirely covered in our national standard; undoubtedly, those laboratories which implement all the national requirements would have no problem being officially accredited for ISO 15189:2012.