May 31, 2019Denise Bland, MHA
Instrument reliability is at the heart of accurate laboratory testing. Without the quality assurance of installation qualification/operational qualification/performance qualification (IQ/OQ/PQ), laboratory testing would be riddled with inconsistent results. Accrediting agencies such as the College of American Pathologists (CAP) and the Joint Commission require IQ/OQ/PQ documentation on all new instrumentation.
At the histopathology lab where I work, IQ/OQ/PQ records have been requested and reviewed near the start of my last three inspections. A knowledgeable inspector will look for all aspects of the expected documentation, which will be compared to your department’s standard operating procedure for new equipment, test, or method validation. Being prepared is crucial, and it all starts with following a set of best practices.
Installation qualification (IQ) is the documented collection of activities necessary to establish that an instrument is delivered as designed and specified, is properly installed in the selected environment, and that this environment is suitable for the instrument. IQ applies to an instrument that is new or pre-owned and to any instrument that exists on site but has not been previously qualified. Certain IQ documentation would also apply to a qualified instrument that has been transported to another location or is being reinstalled for other reasons, such as prolonged storage. This documentation should include system components; instrument delivery, assembly and installation; and network and data storage. For installation verification, the vendor or internal qualified personnel performs the initial diagnostics and testing of the instrument after installation.
After a successful IQ , the instrument is ready for operational qualification (OQ). OQ is the documented collection of activities necessary to demonstrate that an instrument will function according to its operational specifications in the selected environment. This documentation includes secure data storage, backup and archiving, and functional tests. The vendor or user must perform this qualification in the user’s environment.
Performance qualification (PQ) is the documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user and is appropriate for the intended use. It requires performance checks to be made through a series of tests. Those performing PQ should not choose strictly routine test material, as any minor variabilities will have increased visibility on a rare tissue or fluid type. Natural language searches in a laboratory information system (LIS) can be a useful source to guide appropriate sampling. Users should perform a minimum of 20 tests for positive and negative cases. Validation of the instrument must correlate with the manual or automated method previously used; therefore, the medical director should correlate the results with previous testing on the previous platform when completing required sign-off to document the approval of the performance qualification. When the instrument undergoes major repairs, relocation, or modifications, appropriate OQ and/or PQ tests should be repeated.
Common qualification pitfalls
One major pitfall to qualification can be vendors, as they do not always realize their responsibility for IQ/ OQ documentation. If vendors are not aware of or up to date on qualification requirements, their instrument requirements may not meet laboratory needs.
In addition, there are several potential computer-related qualification pitfalls, which users can avoid by educating themselves. It’s important to understand the difference between firmware and stand-alone software. Computerized analytical instruments have operating software, called firmware, without which they cannot function properly. Generally, firmware cannot be altered by users and is considered part of the instrument. The firmware version used while testing, and any later changes or upgrades, should be recorded; however, onsite qualification for firmware is not needed. Nonetheless, tests should still be validated under any significant change to the platform by repeating OQ/PQ as appropriate.
GLP Regulations on EquipmentThe digital age is enhancing the need to understand multiple aspects of qualification. Good Laboratory Practice (GLP) regulations are appropriate resources to provide guidance on equipment design, calibration, and maintenance. To audit vendor accountability, it is crucial to understand proper equipment design parameters. The following are equipment-related US GLP regulations (see 21 CFR part 58):
Many computerized instruments are operated via software, by connecting them to a computer. Design qualification (DQ) should be performed on the software along with validation at the vendor’s site, and the vendor should provide the user with a validation summary. For on-site validation, holistic validation, which includes the hardware and software, is typically more efficient and may be part of operational qualification. Stand-alone software is separate from software supplied by the vendor; analysts often use stand-alone software to operate analytical instruments or process recorded data. User manuals are typically supplied by the software developer, who also administers the validation process and specifies the appropriate development model for the software.
The vendor should provide the end user with the following computer-related information: system description; scope; assumptions; hardware requirements; software requirements; functional requirements; operational requirements; interface requirements; report requirements; data requirements, including integrity, utility, and environmental requirements; security requirements; and regulatory requirements associated with significant changes.
Document, document, document
When in doubt, document, document, document. Normalization of clinical testing is key for optimal repetition of accurate test results. Qualification of equipment and validation of computer systems are not one-time events. Correlation data across instruments or platforms is essential to accurate test performance. How we monitor software upgrades matters. In the time of computational pathology and as always for best outcomes for patient care, leveraging data interpretation in modern health care systems depends on us to provide the right data.
Further ReadingFDA 21 CFR part 820: Quality system requirements for medical device manufacturers
FDA 21 CFR part 11: Regulations on electronic records and signatures
FDA 42 CFR part 493: Laboratory requirements
ISO 17025: General requirements for the competence of testing and calibration laboratories
ISO 15189: Requirements for quality and competence in medical laboratories
CAP’s Laboratory Accreditation Program: An accreditation program covering the entire spectrum of laboratory test disciplines
Clinical Laboratory Improvement Amendments: Federal regulatory standards that apply to all clinical laboratory testing performed on humans in the US, except clinical trials and basic research