The explosive growth of point-of-care (POC) testing menus—and the need for POC teams to oversee testing across many settings—requires rapid adaptability and a dynamic quality management system (QMS). When applied to a person, the word dynamic describes someone who is spirited, energetic, positive, and equipped with new ideas. Not surprisingly, this adjective captures the attributes of our POC coordinators. When applied to a system, dynamic describes one that is flexible during constant change. So, how could you design your POC QMS to provide standardized, stable, and reliable services in the environment of change? Essentially, you apply proven models for designing a QMS for the clinical laboratory and remember the aspects of continuous quality improvement (CQI) to embrace the need for change.
Let’s start with an overview of the quality system essentials (QSE) of the QMS model, following guidelines from the Clinical Laboratory and Standards Institute (CLSI), listed in Table 1 (1).
QSE 1: Organization and Leadership
An organization should identify qualified people who will be responsible for all phases of POC testing (POCT): patient or client preparation, test performance, and reporting of test results. The QMS should charge the POCT committee with determining appropriateness for each offering. The POCT committee also should use key performance indicators (KPI) to assess the effectiveness of each test. This helps the committee make informed decisions in a dynamic fashion to support continued services, implement changes, or discontinue service offerings.
QSE 2: Customer Focus
Customers of the POCT program may include the healthcare providers who receive POCT results, as well as users—even patients—who interact with POCT equipment. A dynamic POCT program seeks customer feedback, assesses the adequacy of customer education, and evaluates timeliness of communications.
Design a mechanism for seeking feedback from your customers and directly addressing shortcomings of the POCT services provided and managed, including education, training, addressing technical issues, and timeliness of communication.
QSE 3: Facilities and Safety Management
The POC QMS needs to assure the safe use of POCT devices, reduce risks of contamination and exposure, and review the reported and potential injuries to customers. Safety also includes assuring the security of protected health information throughout the network and with all interfaces.
QSE 4: Personnel Management
Establishing bidirectional communication between managers and users is essential. This helps ensure that test personnel are adequately trained to maintain and operate equipment, assess the adequacy and quality of specimens, perform patient and quality control testing, and determine whether obtained results can be released and reported. Feedback from testing personnel, or their preceptors and assigned leads, should enable your POC coordinators to adapt the training and assessment of competency.
QSE 5: Supply and Inventory Management
The POC QMS needs to designate responsibilities for communicating with manufacturers and suppliers, and define roles with purchasing, management of supply chain disruptions, and determining provisions for alternate testing. Managers must carefully weigh the decision to maintain a decentralized inventory at the POC versus centralizing a shared inventory.
QSE 6: Equipment Management
The selection of equipment vendors should include providing desired operating specifications in requests for proposals (RFP) and assessing the suitability of equipment. A dynamic POC QMS will solicit feedback and participation of key clients in this process. Other aspects of equipment management include determining maintenance schedules, calibration and calibration verification frequency, and establishing operating procedures related to instrumentation.
QSE 7: Process Management
Although individualized quality control plans (IQCP) may have been based on the premise of reducing the frequency of quality control testing, it is the manager’s assessment of risks in each step of the total test process that guides the QSE of process management.
For each POC service provided, POC coordinators should carefully map workflow diagrams to include processes of preexamination, examination, and postexamination phases of testing. They also must identify potential bottlenecks and risks, and assemble a team to implement processes to overcome them. The goal is to ensure the timeliness of accurate and actionable results to facilitate informed decisions for patient care.
QSE 8–9: Document and Records Management—Information Management
The POC QMS needs to define the systems for assuring secure and confidential records and the flow of information. A dynamic system will always test the integration of results from different measurement procedures, test connectivity, define backup procedures for disruptions to connectivity, and incorporate billing practices to capture all aspects of POCT.
QSE 10: Nonconforming Event Management
A dynamic POC QMS must include processes for detecting and documenting nonconformities. The way nonconforming events are received by the POC management team may include a formal process for receiving customer complaints and staff comments.
Nonconformities also may arise from quality control reviews, proficiency testing or external quality assessment failures, and patient chart reviews. Be certain to define your mechanism for performing a thorough root cause analysis (RCA) process.
Failures are part of all systems, regardless of their design, and how we respond to failures defines our legacy as managers and directors. Failures are opportunities to improve, and those readers who by now have embraced the mantra of being dynamic recognize that one cannot implement effective changes unless a thorough RCA is performed.
QSE 11: Assessments
A POC QMS needs to define a system to audit POCT locations regularly and describe the audit’s methods. The POC QMS should also define the type and reason for the audit and include an initial or new site audit, scheduled audits—quarterly and biennial—and audits targeted as effectiveness checks for implemented corrective actions after nonconforming events.
Equip your POC auditors with an audit checklist to guide the process, and train your POC coordinators to perform thorough audits. Being transparent with customers fosters these relationships and turns the auditing process into one that is perceived as mutually beneficial and not blaming or punitive.
Informally, regular check-ins from your POC coordinators with each testing site convey visibility and facilitate communication about issues related to QC, inventory, and personnel changes. Develop a succinct checklist to document these interactions as well, whether by telephone, in-person, or virtual.
QSE 12: Continual Improvement
Herein lies the QSE that reminds us of the need to embrace change and be dynamic. Importantly, an effective CQI process requires that the POCT committee have a presence in organization-wide continual improvement initiatives.
The CQI process includes incorporating feedback from customers. However, assessing improvements cannot be subjective; they must be measurable. Tie your KPI to the need for operational improvements, and use data analytics to demonstrate advancements resulting from your implementations. Use the audit and assessment process to monitor the effectiveness of CQI.
The POC laboratory director needs to assess whether delegated duties are being performed in accordance with CLIA regularly, and if changes are required to ensure better oversight of the management and delivery of services. The laboratory director also needs to assess the effectiveness of each IQCP, and whether identified risks are adequately mitigated for each method’s total testing process.
POC professionals are known to share best practices and report challenges in the delivery of their services. The recognized leaders in this field are those who identify and anticipate the need for changes in their program-those who embrace the need to be dynamic.
- CLSI. Essential Tools for Implementation and Management of a Point-of-Care Testing Program, 3rd Edition. CLSI guideline POCT04. Wayne, PA Clinical and Laboratory Standards Institute; 2016.
Jack A. Maggiore, PhD, MT(ASCP), DABCC, FAACC, is regional director of point-of-care testing and medical director of the regional core laboratory at Loyola University Medical Center, and assistant professor in the Department of Pathology and Laboratory Medicine at Loyola University at Chicago's Stritch School of Medicine. +Email: [email protected]