Quality Management of Point of Care Testing
Management of POCT can be challenging. Testing may include multiple sites, many different POCT devices/kits, and dozens of operators that have to be managed in order to assure quality patient care. It is therefore important to have a robust POCT management system; monitor all patient data; and maintain compliance with all regulatory requirements.
I. Management Team Models for Quality POCT Operations
A. The Core Laboratory Management Team[i]
During our previous discussion about the increasing importance and demand for Point of Care Testing (POCT), the role of the core laboratory as quality manager of POCT sites was highlighted due to the direct relationship between the two operations. The mutual concerns that are the primary drivers of this direct management model include:
• All Point of Care (POC) testing personnel must be properly trained, and have their competency periodically assessed, even if all their testing is waived
• All instruments involved should be used in accordance with manufacturer’s requirements with quality control, calibration, and maintenance records monitored;
• Test results must be verified as to accuracy and (if the patient had previously been tested) consistent with a patient’s history
• Reagent storage and handling must be monitored
• Utilization of split sampling and proficiency testing is recommended for monitoring quality, even for this waived testing.
The most efficient execution of this model is to have a core laboratory technologist appointed who is responsible for monitoring POC testing, acting as both a liaison, as well as a technical resource for the POC testing staff. This is an important responsibility, as feedback from the field to the laboratory is needed to identify potential operational problems, complaints, and the needs of both patients and staff.
The bottom line is that there should be no difference in the quality of patient care provided by the laboratory, whether performed within the confines of the laboratory itself, or anywhere else. Ultimate responsibility lies with the laboratory administration and staff.
However, there is an alternate model of POCT quality management that goes well beyond utilizing only the personnel of the core laboratory. This model takes POCT outside the laboratory bubble, and includes all departments affected by off-site patient testing:
B. The Interdisciplinary POCT Management Team[ii]
This team gives consideration to the appropriateness of POCT for specific sites, tests and patients; the selection and evaluation of instruments and procedures; staff training and competency assessment; quality assurance, cost/benefit analysis, and risk management. This committee ensures that all local, state, and national regulatory requirements are met. This committee promotes communication and cooperation among different professional groups involved in the POCT program; reviews and approves protocols of POCT procedures; ensures that POCT policies are available to the users; ensures that relevant policies and procedures are followed; and monitors adverse incidents involving POCT instruments.
The membership of the interdisciplinary POCT committee should include representation from all the stakeholders, including but not limited to the following: the Laboratory Director; POCT manager, POCT coordinator, physicians (typically from emergency medicine, critical care medicine, and/or family medicine), nurses, nurse practitioners, nurse manager, infection prevention/control/public health, supply chain, risk management consultant, information technology, and clinical/biomedical engineering. The committee should meet regularly and report to corporate leadership.
The Interdisciplinary POCT committee responsibilities go beyond the scope of core laboratory management, and includes[iii]:
The appropriateness of POCT for specific sites, tests, and patients
Selects and evaluates instruments and procedures
Oversees staff training
Ensures quality assurance measures
Conducts cost/benefit analysis
Utilizes risk management
Ensures all local, provincial/state, and national regulatory requirements are met
Ensures that all POCT policies are available to the users
Monitors adverse incidents involving POCT devices
Reviews and approves protocols for all POCT procedures
However, regulatory standards hold the Laboratory Director ultimately responsible for managing and supervising POCT
II. Remote Monitoring of POCTesting through Digital Technology[iv]
Advances in Digital Technology have now enabled management teams to monitor all aspects of POCT remotely, from test requests to test results; from QC to maintenance records; from inventory control to staffing needs; from documentation of competency to documentation of corrective actions. Use remote monitoring to ensure that all quality standards are met. Here is a sampling of the capabilities of remote monitoring:
Training & Competency Assessments
· Documentation of the initial operator training, as required by CLIA and Accreditation organizations, prior to POC testing, followed by documented competency assessments at specific intervals. Document instances of retraining when needed.
Quality and Compliance
• QC limits and frequency intervals can be set for the test instrument and/or managed remotely through a data management system.
• Data systems can prevent an operator from using the instrument, once the QC interval has been exceeded, or the result is not within acceptable limits.
• QC results for each test instrument and operator can be reviewed and evaluated remotely by laboratory personnel
• Documentation of comments describing corrective action for unacceptable QC results
• Some data management systems allow incorporation of manual QC results.
· Monitor instrument use with a laboratory information system (LIS) or other network system. This communication also allows the LIS to download QC and patient results.
• POC testing can be set up and configured remotely from a single central location with software updates downloaded to the instruments.
• The data management system can serve as a repository for testing locations, instrument serial numbers, and instrument service history and software versions.
• The data management system can also monitor the status of the connected test instruments so that communication and connectivity issues can be addressed promptly.
POCT Operator Management
• Access to a POCT device can be authorized via operator name downloads when the instrument checks the data management system to determine if a particular operator is authorized.
• Any unauthorized operators attempting to use the POCT instrument will be locked out, preventing use.
• To comply with accreditation standards, POCT coordinators can monitor activities such as correlation testing, linearity and analytical measurement range verification, proficiency testing, calibration, and patient identification
• Data systems can automatically capture this data and document it for review. Data can also be entered by hand from manual tests as well.
• Reagent and control lot numbers, and established QC ranges, can be entered into the data system, and uploaded to the POCT instruments.
• Alarms can be set to alert the POCT coordinator when new lots are in use that may require validation.
• Many POCT devices include barcode scanning capabilities that allow reagents and controls to be scanned by operators to verify the current lot number, and prevent use of expired or un-validated reagents.
• Current lot numbers may reside in the data management system.
• POCT data management capability from any computers within or outside of the organization, based on how the system is configured.
III. Regulatory Compliance
CMS does not require all laboratory services to be accredited by the same organization as long as each CLIA certificate is covered by a deemed authority, and in some respects the accreditation standards of one organization may be easier to satisfy in a particular setting than those of another.
As a result, some hospital organizations may choose to have their clinical laboratories accredited by one organization, and their POCT program accredited by another.
Preparation for an accreditation survey:
The same preparation as for an accreditation survey of testing performed in the core laboratory. However, it is important to have a POCT coordinator assigned to accompany the surveyor to all POCT sites, prepared to answer questions specific to how testing is monitored from that location, the qualifications of the onsite testing personnel, the logistics of specimen handing (and splitting with the core laboratory, if needed), as well as reagent storage and data handling.
[i]Futrell, K. POCT: POCT Supports New Demands. Changes in healthcare open door for point-of-care testing to improve outcomes. December 9, 2013. http://laboratory-manager.advanceweb.com/Archives/Article-Archives/POCT-POCT-Supports-New-Demands.aspx [ii] AACC Academy. AACC Guidance Document on Management of Point-of-Care Testing. June 4, 2020. https://www.aacc.org/science-and-research/aacc-academy-guidance/management-of-point-of-care-testing [iii] Ibid. [iv] Futrell, K. Laboratory Management of POCT, Advance, November 2016. http://laboratory-manager.advanceweb.com/laboratory-management-of-poct/