Accreditation combined with standardization, conformity assessment bodies and certain amount of regulations provides trust and conformity guarantee in compliance with desires of involved parties. Latvia as a Member State of the European Union and a country, which has achieved a certain level of development, is obliged to comply both with regulated requirements and with requirements and desires that are set by the increasing demand for qualitative service. If medical devices and pharmacy sectors are regulated for a long time already, for example, information safety (protection of patient data) is an area, which is under development yet along with informatisation and digitisation.

Each year on 9 June the World Accreditation Day is celebrated. The topic in this year is “Accreditation as support for ensuring health and social care”.  Provision of services in appropriate amount and quality is expected also in the areas of health and social care services.

Accreditation is an independent certification made by third party concerning the competence and ability of accredited body or laboratory to perform specific activities (for example, investigation in accordance with specific methods).

In Latvia, in the regulatory scope of health and social care sector, previously conformity assessment bodies and laboratories were accredited in the following areas: medical laboratories; inspectorates, which carry out functional tests of medical devices (including x-ray devices) and monitoring of work area radiation of medical and industrial x-ray devices. Certification bodies accredited in Latvia also certify management systems of health and social care institutions. Starting from 1 October 2014, amendments to the CM Regulations No. 482 “Regulations on protection against the ionizing radiation in medical exposure” come into force, which determine introduction of radiation safety and basic principles of nuclear safety for protection of people against ionizing radiation in medical exposure.

The CM Regulations No. 60 “Regulations Regarding Mandatory Requirements for Medical Treatment Institutions and Their Structural Units” of 20 January 2009 state, that all medical laboratories, if they want to continue provision of services, shall be accredited by the Latvian National Accreditation Bureau (LATAK) until 31 December 2015.

Introduction of mandatory requirements for medical laboratories to be accredited for conformity to requirements of the international standard LVS EN ISO 15189:2013 “Medical laboratories. Requirements for quality and competence” is an important and commendable step in the improvement of quality and competitiveness of medical services.

Through accreditation, a medical laboratory certifies its independence, professionalism and skills in performing laboratory examinations in accordance with requirements of international standards, external regulatory enactments and laboratory procedures. Accreditation is the highest level instrument in the entire hierarchy of quality assurance to certify conformity of provided services to safety, health and environmental protection requirements.

The overall level of operational quality of laboratories in Latvia is not assessed in the last five years since liquidation of the Latvian Health Statistics and Medical Technology State Agency in 2009. It is expensive and disadvantageous for the state to maintain infrastructure or mechanisms for ensuring reliability of medical laboratory services. Therefore, implementation of accreditation functions is entrusted to the national accreditation body – the Latvian National Accreditation Bureau (LATAK), which is a signatory of the Multilateral Agreement (MLA) of the European co-operation for Accreditation (EA).

The practice shows, that laboratories are interested in arrangement of their area of competence in order to gain trust and confidence of the state, that the risks and critical processes are well controlled and managed. There are many risks. Approximately 70% of clinical decisions are made based on results of laboratory investigation: diagnostics, monitoring of the course of disease, therapy monitoring and health status. Frequency of errors depends on how well laboratory processes are managed and supervised, including pre-investigation and post-investigation: preparation of patients, collection of samples and their delivery to the laboratory, verification and interpretation of results. Inadequate results of laboratory investigation can become a basis for erroneous clinical decisions or their delay. Possible consequences – repeated investigation, more lengthy or wrong medical treatment, litigation and damaged reputation – in general, it can be more costly than obtaining of the status of accredited laboratory.

Laboratory errors influence safety of patients (for example, hemotransfusion) and efficiency of health care:
- clinical outcome;
- efficiency of costs.

Example of analytical error:
- Cholesterol: systematic deviation + 1.0 mmol/l increases the number of “sick people” by 25%.

Errors are more significant in simple tumour tests, when a false positive result becomes a cause for unnecessary surgical intervention, whereas a false negative result may leave unnoticed deadly skin cancer.

Frequency of laboratory errors depends on how well laboratory processes are managed and supervised, including pre-investigation and post-investigation, i.e., preparation of patients, collection of samples and their delivery to the laboratory, verification and interpretation of results. Error costs range from 0.15 to 3.0% of laboratory turnover.

The standard includes requirements, which determine obligations of laboratory for cooperation with clinicians, educating on appropriate choice of tests, interpretation of results and, most important – correct preparation of patient and collection of samples, because this is the stage where most errors occur, which result in necessity to perform repeated or additional investigation.

Reduction of costs of laboratory investigation:
1. targeted investigation, samples taken/collected in standardised conditions;
2. repeated investigation in a time interval, during which clinically significant quantitative and qualitative changes of components of human body tissues and liquids can be expected.

Accreditation is based on existing and worldwide recognized standards, which include the best practice and are developed by an international team of experienced and professional experts.  Therefore, in a field, where technical requirements and investigation methods already exist, national requirements may not be developed, using standards instead. Accreditation is determined as an instrument for certifying competence and trust in more than 120 national regulatory enactments.

For example, in France, accreditation is mandatory for all areas of operation of laboratories. In Germany, Belgium, Denmark, Switzerland, Norway, Cyprus and other countries accreditation is mandatory in specific areas, for example, screening of newborns, molecular biology etc. In Germany, Denmark, Slovakia, Spain, Romania, Malta and other countries, a laboratory shall be accredited or comply with specific requirements for quality of performance of tests in order to receive state funding. In many countries accreditation is a mandatory requirement to conclude a cooperation agreement with insurance companies.

In Latvia, there are more than 100 medical laboratories, 14 of them are accredited and applications for accreditation have been received from another four medical laboratories. For comparison: In Estonia, almost 80% of medical laboratories are accredited.

The Quality and Regulations Committee of EFLM (European Federation of Clinical Chemistry and Laboratory Medicine) has prepared a proposal to the European Commission to determine mandatory accreditation of medical laboratories in the European Union.

One of the most significant benefits of accreditation is regular development of organization, implementation of improvements and professional growth. This is a result of professional attitude and long-term thinking.

The role and significance of accreditation increases each year in Europe and across the world. Since LATAK is a signatory of the Multilateral Agreement, the competence of which is regularly verified by auditors appointed by the Council of the European co-operation for Accreditation, the accreditation fact is also recognized internationally, it is increasingly used in mutual recognition of services and as an instrument for demonstration of competence to state administration bodies, which delegate specific conformity assessment activities (testing, calibration, inspection, certification).

Although the accreditation process for laboratories as for any other conformity assessment body is related to investment, it will pay off with surplus in the long-term perspective, especially in terms of the public benefits.

The article is prepared in cooperation with the Ministry of Health.

08.06.2015

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