Whether your laboratory must have ISO 15189 accreditation or chooses to because of its many benefits, the requirements are the same.
NATA accreditation requirements for all ISO 15189 medical laboratories
NATA offers ISO 15189 accreditation through the NATA/RCPA joint accreditation program only. This means that NATA will the use same requirements in every medical laboratory whether they claim Medicare benefits or not. This includes a suite of NPAAC documents that overlap with the NATA documents. The lists of requirements documents are quite overwhelming when you look at them for the first time.
So getting accredited by NATA to ISO 15189 is not as simple as getting a copy of the ISO standard and meeting the criteria. There can be 30 or more documents covering requirements that may be applied to your laboratory. Whether your laboratory is new to accreditation or wanting to extend your scope, you need to make sure you have met all of these.
You may get the impression from the sheer number of documents that you have an enormous amount of work to do to meet these requirements. However, all accreditation requirements are based around what any professional organisation should already be doing to ensure they are putting out reliable test results. Of course, the more complex the testing you are doing, the more involved your processes will be for controlling the quality, but all the requirements fall into the following main areas:
Staff & training
You employ or contract staff to run and work in your laboratory. They have suitable experience and/or qualifications and you supervise those who are still in training. There are job descriptions for each role or person. You give them training when they need it and, for critical tasks, you assess the results of that training. Staff members are ‘signed-off’ when they are ready to work unsupervised.
At regular intervals you reassess staff members to determine if they need further training and you support your staff by providing professional development opportunities.
The physical environment of the laboratory
The collection, laboratory, office and storage facilities are arranged in such a way as to avoid cross-contamination between samples, and to provide a secure and safe working environment for the staff. If methods call for any specific environmental conditions (temperature, humidity, sterility, radiation, vibration levels etc) you provide those conditions and monitor them. When using shared facilities or borrowed equipment, you put in extra effort to make sure these conditions are provided. You keep the facilities clean and uncluttered.
Access to the laboratory and to patient information is controlled. For most clinical laboratories, this means locked doors and strictly-controlled access to records and results.
Equipment & consumables
You have provided all the equipment necessary to perform the testing, and any other processes such as sample collection and preparation. The equipment is able to achieve the necessary accuracy, and complies with any specifications in the methods. You have up-to-date instructions on how to use the available equipment and you make sure that only trained people use it. You check or calibrate the equipment regularly if it has a significant effect on the test results.
Consumables are received, stored and checked to ensure that they are not damaged or invalidated in any way. Consumables not approved for use are quarantined from those in use.
Collection, transport and handling of samples
All samples are uniquely identified and they are not damaged by transport, storage or other arrangements. You record any problems with the samples before you start processing or testing.
If your organisation collects the samples, this is done by trained staff with access to current instructions for collection of various types of samples. You also provide this information to anyone else who collects samples to send to your laboratory.
You use the right methods based on client requirements and technical validity, including clinical utility. These may be commercial or in-house methods. Either way, you have made sure that the methods can accurately measure the quantity in the types of samples you receive.
In-house developed methods are validated to make sure they produce reliable test results. This validation includes estimating the measurement uncertainty for the method. (OK this last bit is a little daunting for some, but once you know how to do it, it’s do-able, if not easy.)
You have identified the critical control points in the methods.
If you use commercial methods (approved by the TGA for diagnostic purposes) you verify that the methods work properly in your hands. When you subcontract any testing, processing or interpretation of results, you have a process in place to make sure these are valid.
QC and proficiency testing
You have a system of quality control testing and/or external quality assurance programs that ensures your test results are valid and you monitor the results for trends.
Recording and reporting test results
You keep complete records of testing, including original observations, identity of the staff member, identity of any critical pieces of equipment and any other factors that can affect the test result significantly. Test reports are factual and can be understood by the client, whilst containing all required information.
Management and quality improvement
Across the top of your technical arrangements for running the laboratory well, you have a management structure that supports the effective running of the laboratory. You have considered where conflicts of interest may arise within your organisation and you make sure that there are enough staff members to do the work. Key processes such as quoting and/or accepting new work, purchasing, subcontracting and customer feedback are planned and defined. You have documented all of your key processes (including the technical areas) and have a system to make sure staff can access up-to-date versions of all procedures.
You hold regular management meetings to gain perspective on the overall operation of the business. Internal audits happen regularly to make sure your system is still running the way you intended. There is a system for dealing with complaints, improvement suggestions and other non-conformances that leads to improvements in your performance. And finally, you keep records of all management and quality activities.
Details of the criteria can be found in the following documents:
- ISO 15189 Application Document – Medical Testing – Supplementary requirements for accreditation
- General Equipment Tables
- NATA Rules
- NATA Procedures for Accreditation
- 20 – 30 policy circulars, technical circulars, annexes and information papers.
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