Public HealthPH2FDevelop protocols for inspecting laboratories undertaking regulatory compliance analyses, in conjunction with respective accreditation bodies
Regulators support systematic audits or inspections of accredited laboratories on behalf of national health authorities.
If delegated to regulators, this action is performed in accordance to transparent inspection protocols, predefined and accessible to accredited laboratories.
These protocols must present how inspections are conducted, approved, and reported. Regulators must also transparently outline laboratories’ obligations and rights during inspection procedures, along with the time sequence of audits.
Expected outcomes
The European Council adopted Directive 2004/10/EC and Directive 2004/9/EC relating to the application of the good laboratory practice (GLP) principles. These Directives lay down the obligation of Member States to designate the authorities responsible for GLP inspections in their territory.
In Ireland, the National Standards Authority (NSAI) provides requirements for reporting and for the internal market (i.e., mutual acceptance of data), and procedures for inspection and verification of good laboratory practice (GLP). The standard which details criteria in relation to GLP and quality assurance is ISO 17025. Although accreditation to an NSAI standard is not a license requirement, all laboratories conducting analysis should have in place a robust quality system to demonstrate compliance with license conditions.
In determining the performance characteristic of a method, and determining its suitability for test matrix data, the following must be obtained through evaluation and testing:
- Limit of quantification: the lowest concentration that can be determined with acceptable laboratory reproducibility and trueness.
- Accuracy: how close the measurement is to the true value expressed as the mean.
- Precision: how close the measurement is to the mean value expressed as the standard deviation.
- Uncertainty of measurement: uncertainty in the measured value.
To determine the suitability of a method and investigate for known interference, ‘spiking’ should be conducted. This is the adding of a predetermined sample to a concentration in the range of interest or at least a minimum of 50% of this value.
Recovery of the added spike should not be significantly less than 90 percent or greater than 110 percent. When testing organic methods, recovery of the added spike should not be significantly less than 80 percent or greater than 120 percent.
Examples
In Costa Rica, the Regulation on Drinking Water Quality stipulates that any laboratory performing physical, chemical and microbiological analyses must have a sanitary operating license granted by the Ministry of Health, in accordance with Executive Decree No. 34728-S, ‘General Regulation for the Granting of Operating Licenses by the Ministry of Health.’ This framework stipulates a verification inspection system according to which all establishments and activities that have received a sanitary operating license shall be subject to the inspection or auditing of their services, whether it is programmed, conducted in response to a report, if required, or conducted as part of a selective testing initiative aiming to verify conditions that were stated under oath. If the establishment is proven to be in breach of established requirements, the health authority shall proceed to order the revocation of the granted license and the closure of the Laboratory.
In Colombia, Decree No. 1575/2007 establishes the need for laboratories that analyze water for human consumption to be previously authorized by the Ministry of Social Protection, and for sanitary authorities at department, district and municipal levels to supervise the quality of water for human consumption. To this end, among other actions, such authorities may inspect, supervise and monitor laboratories that perform physical, chemical and microbiological analyses of water for human consumption.
Links
Costa Rica: Executive Decree No. 38924-S and General Regulation for the Granting of Operating Licenses by the Ministry of Health
http://www.agq.com.es/documentos/DE_289_Decreto_No_38924_S_Reglamento_para_calidad_agua_potable.pdf
Colombia: Decree 1575 of 2007
https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=30007
Irish Environmental Protection Agency
National Standards Authority of Ireland (NSAI)
OECD Guidance on principles of Good Laboratory Practice (GLP):
Internal capacities needed and the role of partners
Developing protocols for inspecting laboratories undertaking regulatory compliance analyses, in conjunction with respective accreditation bodies, requires prior capacity in terms of an understanding of laboratory testing capacities and limitations, so as to set realistic inspection targets.
Protocols will also need to factor in the capacity of inspecting institutions. Development partners can support ministries of helath in providing targeted technical assistance for developing protocols, and in capacity training to conduct inspection activities.