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Nearly all lab equipment and medical devices must have quality control and maintenance procedures to ensure safety and accuracy. Those procedures are closely regulated under the Clinical Laboratory Improvement Amendments (CLIA). Only a few devices, like HemoScreen, can be managed through alternative quality control procedures.
Due to advancements in technology, the CDC and CMS (CLIA 2019) have made possible the usage of Equivalent Quality Control options depending on the comprehensiveness of internal controls and the consistency of the test systems over time.
PixCell Medical’s revolutionary hematology analyzer is designated as a moderately complex device under CLIA, yet it is the only blood analyzer that is cleared for point-of-care use, and due to its internal electronic controls and stability, it is eligible for an individualized quality control plan (IQCP).
Here’s a breakdown of the advantages and obstacles of using an IQCP for maintenance and quality control compliance.
IQCP provides labs the opportunity to tailor a QC plan for their unique testing environment and thereby offers flexibility for meeting regulatory requirements appropriate for the testing performed. IQCPs require some forethought and resources before implementation, but there are significant benefits to consider when making the switch. ICQPs bring you standardized quality control while being customizable, adjustable, efficient, and cost-effective.
Transitioning to an IQCP from traditional quality control measures allows you more flexibility. Each IQCP is not only individualized to the instrument but also to each facility’s needs.
An IQCP is tailor-made to account for specific circumstances within your department or lab rather than being held to cookie-cutter standardized guidelines. You can design your quality control measures from start to finish, which allows you to forego guidelines that aren’t relevant or applicable to your lab.
A comprehensive IQCP will address all ongoing compliance needs for quality control and assurance–all while working within your department’s unique systems, resources, and operations.
Things don’t always go according to plan–especially in healthcare. HemoScreen is a portable device and has a variety of applications in medicine. As such, it benefits from having a quality control plan as flexible as the machine.
Due to its customizable nature, an IQCP is also continuously modifiable. Having the ability to make continual improvements and adjustments brings peace of mind to plan designers and those carrying out quality checks. Unforeseen anomalies or sources of error can be resolved without affecting department systems or patient care.
Every medical device and instrument has specific quality control requirements, and failure to comply has consequences.
Simply following the manufacturer’s instructions for quality control may not be sufficient. Some manufacturer instructions are not stringent enough to meet CLIA or CAP requirements. Non-compliance can leave you open to penalties, censure, or other disruptions to service and reimbursement.
Conversely, CAP guidelines require multiple daily quality checks for most instruments. Especially for those affected by the medical technologist shortage, this can be a significant burden on staff members, a drain on department resources, and cause delays to patient care.
An IQCP for HemoScreen reduces the QC requirements from multiple daily checks to just once every 30 days. Quality measures other than an IQCP may result in too few or too many quality checks.
Having a comprehensive IQCP in place reduces the risk of errors and inspection failures, while also reducing the overall quality control burden.
The current state of providing health care services requires many to “do more with less.” Departments face ongoing hits to their budgets, staffing, and other resources.
By itself, HemoScreen can help lower ownership costs by reducing the financial burdens associated with competency, consumables, service, and operations.
Installing HemoScreen and implementing an associated IQCP gives you a lab-grade hematology analyzer and a CLIA-compliant quality control plan with less financial strain.
This dynamic system is highly flexible, efficient, and cost-effective. With fewer quality checks and improved resource utilization, HemoScreen can further reduce your overall cost of ownership compared to traditional hematology analyzers.
Some facilities may find a few challenges when transitioning to IQCPs from traditional quality control measures.
Complex laboratory equipment, like hematology analyzers, often require particular quality control measures to maintain accuracy, safety, and quality of patient care. Most instruments, governed by CAP guidelines, are unable to qualify for an IQCP due to the frequent maintenance and calibration interventions that may affect instruments’ stability over time.
As an exception, HemoScreen is the only device of its kind to meet the criteria for an alternative quality control procedure. Implementing an IQCP gives you flexibility, reduces resource waste, and increases quality control efficiency.
The initial building and implementation of a custom IQCP takes time and resources. Quality control planners and laboratory directors must also know how to design a comprehensive IQCP.
Staff must then be trained in following the plan. Once an IQCP is in effect, it may need future monitoring and adjustment to maximize efficiency.
While an IQCP is flexible and more efficient than traditional quality control measures, it is still a method of quality control. As such, it remains subject to regulatory requirements under CLIA.
An IQCP is meant to identify potential sources of error and ensure the quality of the device and testing process. The following components must be included:
All staff must adhere to the established IQCP to maintain quality control and safety standards. A department may be subject to penalties from inspectors if staff fail to follow the plan or the IQCP is found to be insufficient.
Looking for more information on how HemoScreen can bring down lab costs and make your department more efficient? Blood collection and analysis with HemoScreen’s disposable cartridge system is quick and easy. Contact us at PixCell Medical and schedule a demo today!
Our portable POCT analyzer provides lab-quality results in just 5 minutes without regular calibration or maintenance. We’ll walk you through how an IQCP can eliminate daily quality control requirements and other ways HemoScreen is the pragmatic choice for your budget and resources.
(*) Please note: training must be defined by local, state and federal regulations. In the USA, training is defined for CLIA moderate complexity devices.
