L
aboratory testing has been regulated rigorously for many years. The Clinical Laboratory Improvement Amendments (CLIA), adopted in 1988 and revised in 2003, provide the basis for regulatory governance of laboratories. The College of American Pathologists (CAP) and The Joint Commission (TJC) both use the CLIA standards as a basis for inspection; and, so, the stringent regulations around testing and reporting accuracy pervade all laboratory inspection systems.
Laboratory science is a highly disciplined field, with great preciseness applied to quality control (QC), quality assurance, personnel competency, and test-reporting accuracy. The number of personnel in a laboratory is a finite set, and the testing itself is performed in a highly controlled environment. When testing moves outside the laboratory, either by its performance with point-of-care (POC) tests or by entering the results of tests performed at other institutions into the local electronic medical record (EMR), the oversight of testing performance and result recording has reached a level of complexity that requires thought and structure to ensure accuracy. The regulation of point-of-care testing (POCT), however, has been slower by both regulatory bodies — CAP and TJC — and the managing hospitals. POCT was initially unregulated, and the overseeing hospitals made little effort to manage the rapidly emerging technologies.1
The purpose of this article is to describe how one children’s hospital has approached testing performed outside the laboratory, with specific emphasis on POCT and transfer of external lab results into the EMR.
Background
Children’s Medical Center (CMC) of Dallas is a private, not-for-profit hospital — and one of the largest pediatric healthcare providers in the nation (licensed for 559 beds and an additional 72 at a smaller hospital within 30 miles). CMC is affiliated with the University of Texas Southwestern Medical Center-Dallas as a primary pediatric teaching facility, with over 50 subspecialty programs.
POCT, defined as laboratory diagnostic testing performed at or near the site where clinical care is delivered, makes up a significant portion of the annual laboratory testing performed at CMC, averaging ~10,000 patient encounters and 12,000 to 15,000 billable tests performed each month (~160,000 per year). This comprises approximately 10% of total annual lab tests, which averages 1.7 million. Both the actual and proportional numbers of POC tests are increasing, congruent with the overall trend of POCT expansion at an average rate of 9% per year over the previous eight years.2
At CMC, more than 2,500 individual users have access to approximately 185 instruments from a variety of POC manufacturers in up to three different sites. Such fast-paced technology, combined with the management, compliance, and control of a large number of operators at several different sites has all the makings of a logistical nightmare for the most well-managed team. Indeed, prior to the advent of several changes, many laboratory fundamentals such as competency, compliance, training, and overall coordination (primarily between the laboratory and POC sites) were lacking at CMC. After a thorough manual overhaul of these factors, the then-manager/now-director began to formulate a plan to more effectively manage the POCT department. Two major initial roadblocks to effective control were identified: a) the sheer volume of paper required in order to maintain compliance and competency records, and b) the disorganized fashion in which the records (e.g., the expiration dates of employee competence) were maintained and kept up to date.
A search for an automated POCT-management system was initiated. Taking into account existing frameworks and, of course, finances, an appropriate automated database-management system was selected. The second organizational issue was giving hundreds of employees the tools to maintain their own competencies — instead of attempting to have one employee police the entire workforce.
Current design
CMC’s POCT team has a linear hierarchical centralized design with a supervising manager and a senior medical technician. With the support of a group of clinical educators and regional supervisors, the POCT team essentially oversees the POC duties of 2,500 people (including patient-care assistants and technicians, nurses, anesthesiologists, and surgeons.) The concept of a centralized model refers to the management of all POCT aspects (including device and reagent validation, quality control, compliance, and more) by the POCT team. Three or four people can effectively control all aspects of this 2,500+ user group on a daily basis, demonstrating the benefits of automation and technology.
Using technology to manage a POCT program
The POCT information is managed using an ID badge to access the POCT instruments. Following simple on-screen instructions, the user badge is scanned to log in to the instrument, followed by scanning the patient wristband to identify and link to the ensuing laboratory result. Once the test is complete, the result is stored in the POCT instrument until it is docked at a station connected to CMC’s network to the database that stores and releases all POCT results. These are released to the laboratory information system, or LIS, which adds the latest patient information to the test result and, in turn, releases the information to the main EMR at CMC.
Training, competency, compliance
Training and managing the competency of staff is simplified with an automated POCT management system. In accordance with CAP regulations, new full-time employees are assessed at six months and at one year of employment (and annually thereafter).
Via commonly used instruments at CMC, staff members are alerted 30 days prior to the expiration of their competencies. The middleware database also shows the expiration date. Once an employee’s competency has expired, that user is locked out of all POCT instrumentation by disallowing his badge scan. If an entire department has compliance issues, POCT instrument removal may be enacted.
CMC also has an online procedure manual for every department and procedure. Instead of using traditional paper assessments, requiring manual grading and storage, an online training system delivers online assessments and record keeping. Both applications help keep paper to a minimum and give employees the tools and responsibility to manage their own competency.
Quality control and compliance
Daily QC values are easily accessed with the use of the database and are obviously representative of the instrument on that date and time. (The data is not subject to falsification — for example, if QC has not been performed correctly.) With the increased reliability of some instruments, electronic QC can be performed on a daily basis, instead of “wet” QC (after an initial verification period), which makes the QC process easier, faster, and more reliable. If the daily QC requirement is not fulfilled with the vast majority of POCT instruments, another “lockout” feature prevents usage of the unit.
Other quality measures are also more easily assessed with automation; for example, monitoring user error rate when performing POC tests. Despite the simplicity of the technology, errors — usually related to scanning — do occur. The results of such tests are held for POC review and are not released to the EMR until verified with the POCT operator who performed the test. Statistics of such errors are easily obtained and are provided to the supervisors of each floor, including total tests, total errors, error percentage, the <2% error-rate goal and, finally, the performance of all other floors.
Additional benefits
The numbers of tests performed are readily available, providing easier and more accurate incorporation of these costs into the budget. Useful benefits to the database monitoring system include the ability to locate instruments (last location docked) and the last user (last badge scanned.) This permits management of the current unit inventory as well as finding misplaced devices.
CMC’s current POC management design gives the end-users control over many of their own operations and processes while still functioning within the control and guidelines established by the POC department. One important point should be emphasized: Despite the level of control maintained with such automation, without the strong management team and a leader committed to fostering relationships and lines of communication between the POC team and the end-users, it would be meaningless.
Richard Hopley, MD, works in the Department of Pathology at the University of Texas Southwestern Medical Center-Dallas.
Amy Sigman, MT(AMT); Kenneth Carr; and Jennifer Roberts, MT, are employed with the Children’s Medical Center of Dallas. At the time of this writing, Beverly Rogers, MD, worked in the Department of Pathology at both the University of Texas Southwestern Medical Center-Dallas and the Children’s Medical Center of Dallas.
References
- Lee-Lewandrowski E, Lewandrowski K. Point-of-care testing: an overview and a look to the future. Clin Lab Med. 2001;21:217-240.
- Cambridge Consultants. Point-of-care: the demise of high throughput screening? Cambridge, England: Cambridge Consultants; 2006;1-9.
