The Importance of Meeting ISO 15189 Requirements

The Importance of Meeting ISO 15189 Requirements

Laboratory accreditation provides formal recognition to competent laboratories, providing a means for customers to identify and select reliable services (CALA, n.d.). Use of accreditation standards by clinical laboratories enables them to drive gains in quality, customer satisfaction, and financial performance. This is essential at a time when laboratory budgets are shrinking.

Some key benefits include:

  • Recognition of testing competence – as mentioned above, customers can recognise the competence of a lab with an internationally recognised standard.
  • Marketing advantage – accreditation can be an effective marketing tool as labs can demonstrate their quality and overall competence.
  • Benchmark for performance – laboratories can determine whether they are performing to the appropriate standards and provides them with a benchmark to maintain that standard.

To maintain the global recognition gained from accreditation, labs are evaluated regularly by an accreditation body to ensure their continued compliance with requirements, and to check that standards are being maintained. (CALA, n.d.).

[mpc_divider preset=”preset_0″ content_type=”title” content_padding_divider=”true” content_padding_css=”padding-top:0px;padding-right:10px;padding-bottom:0px;padding-left:10px;” font_preset=”mpc_preset_17″ font_color=”#646363″ font_size=”20″ font_line_height=”1″ font_transform=”uppercase” font_align=”center” title=”Impact on healthcare” icon_type=”character” icon_character=”P” icon_color=”#98c96a” icon_size=”30″ lines_color=”#646363″]

In a comprehensive study conducted by Rohr et al. (2016) it was found that, while accounting for as little as 2% of total healthcare expenditure, in vitro diagnostics (IVD) account for 66% (two thirds) of clinical decisions. Despite such a small percentage of budget dedicated to it, IVD plays a huge role in patient care so it is vital that there is guidance in place to ensure quality standards are met. Poor performance of tests at any stage of care and treatment can reduce the effectiveness of treatment and deny appropriate care to patients in need (Peter et al., 2010).

[mpc_divider preset=”preset_0″ content_type=”title” content_padding_divider=”true” content_padding_css=”padding-top:0px;padding-right:10px;padding-bottom:0px;padding-left:10px;” font_preset=”mpc_preset_17″ font_color=”#646363″ font_size=”20″ font_line_height=”1″ font_transform=”uppercase” font_align=”center” title=”ISO 15189″ icon_type=”character” icon_character=”P” icon_color=”#98c96a” icon_size=”30″ lines_color=”#646363″]

ISO 15189 is an international accreditation standard that specifies the quality management system requirements particular to medical laboratories and exists to encourage interlaboratory standardisation, it is recognised globally.

Meeting ISO Requirements

Scroll through below to learn how ISO 15189 regulates aspects of a clinical laboratory and how Randox can help you meet these suggestions.

The Importance of Meeting ISO 15189 Requirements
[mpc_carousel_anything single_scroll=”true” loop=”true” rows=”1″ cols=”1″ gap=”0″ start_at=”1″ item_border_css=”border-width:1px;border-color:#f9d6ae;border-style:dashed;border-radius:10px;” item_odd_background_color=”#fafafa” item_even_background_color=”#fafafa” mpc_navigation__preset=”mpc_preset_29″ mpc_navigation__prev_margin_divider=”true” mpc_navigation__next_margin_divider=”true” mpc_navigation__padding_divider=”true”]

Review of QC data

“The laboratory shall have a procedure to prevent the release of patient results in the event of quality control failure. When the QC rules are violated and indicate that examination results are likely to contain clinically significant errors, the results shall be rejected…QC data shall be reviewed at regular intervals to detect trends in examination performance

 – ISO 15189:2012

Acusera 24∙7 will automatically apply QC multi-rules, alert you to or reject any results that violate the QC multi-rules or performance limits, generate a variety of charts allowing visual identification of trends and provide access to real-time peer group data to assist with the troubleshooting process.

Calculation of MU

The laboratory shall determine measurement uncertainty for each measurement procedure in the examination phases used to report measured quantity values on patients’ samples. The laboratory shall define the performance requirements for the measurement uncertainty of each measurement procedure and regularly review estimates of measurement uncertainty.”

– ISO 15189:2012

Acusera 24∙7 is the only QC data management platform that incorporates the automatic calculation of Measurement Uncertainty (MU) as well as other performance metrics, including Total Error.

More about Measurement Uncertainty and how Acusera 24∙7 can help

Commutability

“The laboratory shall use quality control materials that react to the examining system in a manner as close as possible to patient samples”

– ISO 15189:2012

Acusera True Third Party Controls are fully commutable, behaving like a real patient sample, reducing the need to re-assign QC target values when the reagent batch is changed, reducing labour and costs.

Medical decision levels

“The laboratory should choose concentrations of control materials, wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made”

– ISO 15189:2012

Acusera True Third Party Controls are designed to challenge instruments across the entire clinical reporting range.

Comparison of results across instruments

“Laboratories with two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers

– ISO 15189:2012

Acusera 24∙7 is capable of combining multiple data sets on a single Levey-Jennings, Histogram of Performance Summary chart, enabling at-a-glance performance review and comparative performance assessment. A unique multi-instrument report is also available via our RIQAS EQA programme allowing performance of each instrument to be compared.

Third Party Control

“Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer”

– ISO 15189:2012

Acusera True Third Party Controls are manufactured completely independently of and calibrators and assigned values through a pool of instruments across the world, making them true third party controls.

[/mpc_carousel_anything]

At a conference in Belgium in 2016, data, which highlighted the most common areas of non-conformance in laboratories, showed that nonconformities were most prevalent in sections 5.5 and 5.6 of ISO 15189. This data is visualised in fig. A below. Furthermore, a study by Munene et al. (2017) has had similar findings, as visualised in fig. B. The greatest number of nonconformities occur in the sections that are concerned with insufficient assay validation and quality of examination procedures. These studies specifically identified the lack of independent controls, QC not at clinically relevant levels, commutability issues, and a lack of interlaboratory comparison as major issues.

Randox Quality Control products are designed to target these areas, making it easier to conform to ISO 15189 standards.

[mpc_textblock content_width=”100″ font_size=”12″ margin_divider=”true” margin_css=”margin-bottom:2px;”]Fig. A[/mpc_textblock]
ISO 15189 requirements - non-conformances
[mpc_textblock content_width=”100″ font_size=”12″ margin_divider=”true” margin_css=”margin-bottom:2px;”]Fig. B[/mpc_textblock]
ISO 15189 requirements - non-conformances
[mpc_divider preset=”preset_0″ content_type=”title” content_padding_divider=”true” content_padding_css=”padding-top:0px;padding-right:10px;padding-bottom:0px;padding-left:10px;” font_preset=”mpc_preset_17″ font_color=”#646363″ font_size=”20″ font_line_height=”1″ font_transform=”uppercase” font_align=”center” title=”Continue Reading” icon_type=”character” icon_character=”P” icon_color=”#98c96a” icon_size=”30″ lines_color=”#646363″]
[mpc_callout preset=”preset_1″ layout=”style_3″ title_font_preset=”mpc_preset_17″ title_font_color=”#6b6b6b” title_font_size=”15″ title_font_line_height=”1.5″ title_font_transform=”uppercase” title_font_align=”center” title=”Acusera Third Party Controls” content_width=”100″ content_font_preset=”mpc_preset_44″ content_font_color=”#848484″ content_font_size=”17″ content_font_line_height=”1.75″ content_font_align=”center” content_margin_divider=”true” content_margin_css=”margin-top:-10px;” icon=”etl etl-browser” icon_color=”#646363″ icon_size=”30″ icon_padding_divider=”true” icon_padding_css=”padding-bottom:10px;” icon_margin_divider=”true” icon_margin_css=”margin-bottom:0px;” background_color=”rgba(239,239,239,0.5)” padding_divider=”true” padding_css=”padding-top:37px;padding-right:30px;padding-bottom:37px;padding-left:30px;” mpc_button__preset=”preset_1″ mpc_button__block=”true” mpc_button__url=”url:https%3A%2F%2Fdev.randox.com%2Facusera-laboratory-quality-control%2F|||” mpc_button__font_preset=”mpc_preset_20″ mpc_button__font_color=”#ee7402″ mpc_button__font_size=”14″ mpc_button__font_transform=”capitalize” mpc_button__font_align=”center” mpc_button__title=”Visit” mpc_button__icon=”etl etl-browser” mpc_button__border_divider=”true” mpc_button__border_css=”border-top:2px;border-right:2px;border-bottom:2px;border-left:2px;border-color:#ee7402;border-style:solid;” mpc_button__padding_divider=”true” mpc_button__padding_css=”padding-top:12px;padding-right:30px;padding-bottom:12px;padding-left:30px;” mpc_button__margin_divider=”true” mpc_button__margin_css=”margin-top:11px;” mpc_button__hover_font_color=”#ffffff” mpc_button__hover_background_color=”#ee7402″ mpc_button__hover_background_effect=”expand-horizontal” mpc_button__hover_background_offset=”0″ mpc_button__hover_border_divider=”true” mpc_divider__disable=”true” mpc_divider__width=”10″ mpc_divider__lines_color=”#dddddd” mpc_divider__lines_weight=”2″ mpc_divider__margin_divider=”true” mpc_divider__margin_css=”margin-bottom:13px;”][/mpc_callout]
[mpc_callout preset=”preset_1″ layout=”style_3″ title_font_preset=”mpc_preset_17″ title_font_color=”#6b6b6b” title_font_size=”15″ title_font_line_height=”1.5″ title_font_transform=”uppercase” title_font_align=”center” title=”Interlaboratory Data Management” content_width=”100″ content_font_preset=”mpc_preset_44″ content_font_color=”#848484″ content_font_size=”17″ content_font_line_height=”1.75″ content_font_align=”center” content_margin_divider=”true” content_margin_css=”margin-top:-10px;” icon=”etl etl-browser” icon_color=”#646363″ icon_size=”30″ icon_padding_divider=”true” icon_padding_css=”padding-bottom:10px;” icon_margin_divider=”true” icon_margin_css=”margin-bottom:0px;” background_color=”rgba(239,239,239,0.5)” padding_divider=”true” padding_css=”padding-top:37px;padding-right:30px;padding-bottom:37px;padding-left:30px;” mpc_button__preset=”preset_1″ mpc_button__block=”true” mpc_button__url=”url:https%3A%2F%2Fdev.randox.com%2Facusera-24-7-interlaboratory-data-management%2F|||” mpc_button__font_preset=”mpc_preset_20″ mpc_button__font_color=”#ee7402″ mpc_button__font_size=”14″ mpc_button__font_transform=”capitalize” mpc_button__font_align=”center” mpc_button__title=”Visit” mpc_button__icon=”etl etl-browser” mpc_button__border_divider=”true” mpc_button__border_css=”border-top:2px;border-right:2px;border-bottom:2px;border-left:2px;border-color:#ee7402;border-style:solid;” mpc_button__padding_divider=”true” mpc_button__padding_css=”padding-top:12px;padding-right:30px;padding-bottom:12px;padding-left:30px;” mpc_button__margin_divider=”true” mpc_button__margin_css=”margin-top:11px;” mpc_button__hover_font_color=”#ffffff” mpc_button__hover_background_color=”#ee7402″ mpc_button__hover_background_effect=”expand-horizontal” mpc_button__hover_background_offset=”0″ mpc_button__hover_border_divider=”true” mpc_divider__disable=”true” mpc_divider__width=”10″ mpc_divider__lines_color=”#dddddd” mpc_divider__lines_weight=”2″ mpc_divider__margin_divider=”true” mpc_divider__margin_css=”margin-bottom:13px;”][/mpc_callout]
[mpc_divider preset=”preset_0″ content_type=”title” content_padding_divider=”true” content_padding_css=”padding-top:0px;padding-right:10px;padding-bottom:0px;padding-left:10px;” font_preset=”mpc_preset_17″ font_color=”#646363″ font_size=”20″ font_line_height=”1″ font_transform=”uppercase” font_align=”center” title=”Contact Us” icon_type=”character” icon_character=”P” icon_color=”#98c96a” icon_size=”30″ lines_color=”#646363″][gravityform id=”11″ title=”false” description=”false” ajax=”false”]
[mpc_divider preset=”preset_0″ content_type=”title” content_padding_divider=”true” content_padding_css=”padding-top:0px;padding-right:10px;padding-bottom:0px;padding-left:10px;” font_preset=”mpc_preset_17″ font_color=”#646363″ font_size=”20″ font_line_height=”1″ font_transform=”uppercase” font_align=”center” title=”References” icon_type=”character” icon_character=”P” icon_color=”#98c96a” icon_size=”30″ lines_color=”#646363″]

CALA. The Advantages of Being an Accredited Laboratory. Canadian Association for Laboratory Accreditation. Retrieved from http://www.cala.ca/ilac_the_advantages_of_being.pdf

Munene, S., Songok, J., Munene, D., & Carter, J. (2017). Implementing a regional integrated laboratory proficiency testing scheme for peripheral health facilities in East Africa. Biochemia Medica, 110-113. http://dx.doi.org/10.11613/bm.2017.014

Peter, T., Rotz, P., Blair, D., Khine, A., Freeman, R., & Murtagh, M. (2010). Impact of Laboratory Accreditation on Patient Care and the Health System. American Journal Of Clinical Pathology134(4), 550-555. http://dx.doi.org/10.1309/ajcph1skq1hnwghf

Rohr, U., Binder, C., Dieterle, T., Giusti, F., Messina, C., & Toerien, E. et al. (2016). The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLOS ONE11(3), e0149856. http://dx.doi.org/10.1371/journal.pone.0149856


Clinical Laboratory Survey