Over the past 50 years, we have witnessed a rapid evolution in the availability of point-of-care laboratory testing. Point-of-care (POC) testing is best defined as laboratory testing near the patient, which rapidly provides results for immediate patient care management. There are several reasons for growth in the near patient testing market:
- The advances in technology and informatics have enabled greater sophistication and miniaturization of testing devices.
- The growth of electronic medical records (EMRs) provides a central repository for all patient care information. This, in turn, has made the use of point-of-care technology more attractive in hospitals, offices, clinics, urgent care centers and emergency departments, because the information obtained at the various locations can be more widely available to multiple providers. In addition, today some patient devices used in the home can be downloaded into the electronic medical record.
- The ability to provide the clinician with data while the patient is being examined leads to more rapid and informed decisions for diagnosis and treatment of diseases, both acute and chronic. This, in turn, has an immediate impact on the quality of care. The tremendous growth in the number of analytes available via POC testing also has had an enabling role.
- The information provided by rapid availability of laboratory results guides the transition to a value-based reimbursement model rather than a volume-based reimbursement model of medical care delivery. Incentive reimbursement bonuses related to quality improvements are offered to offset the loss of fee for service reimbursement for laboratory testing.
- Consumerism has expanded in all areas of our lives, including medical care. Today, consumers expect answers immediately. This immediacy, partnered with the desire for one-stop shopping, highlights the value that laboratory testing at the time of medical examination can bring to the patient, as well as the clinician.
Advances in technology and instrumentation
Great change in laboratory medicine has occurred during the last 50 years. Laboratory devices available in the 1960s and 1970s were large, had limited menus, required considerable floor space and many technologists. Today, we have hand-held devices that can perform many of the same tests that are performed on larger analyzers, and there is less need to send a specimen for examination at a central laboratory. Witness the blood gas analyzers that were used in the 1970s and 1980s and compare their size with hand-held devices used today in many facilities to perform the same analyses. Today, in some emergency departments, we have multiplexed molecular testing for syndromic pathogens, and these allow accurate diagnosis in less than two hours. Point-of-service testing has come about as a result of improved technology and miniaturization of instruments.
Electronic medical records (EMRs)
Interfaces of the electronic medical record (EMR) with laboratory instruments, whether in a central laboratory or with smaller POC analyzers, enables all the laboratory testing performed on a given patient – even from multiple locations – to be complied into one record. In addition, the waived tests used every day at the point of care can be manually entered into the electronic record.
Today, patients are receiving care from multiple practitioners in diverse locations. The ability to store all the laboratory information being generated from these different facilities in one repository has the benefit of avoiding duplicate testing and associated cost. We now have available multiple wearable health-related devices. Results obtained and stored by these devices, can, in many instances, be downloaded into a central data bank for use across the whole spectrum of medical care.
Glucose testing is the most common point-of-care test performed, with the lion’s share of it being performed in the home. The ability to download these results into the electronic record enables the practitioner to evaluate the patient’s status, either in the recent past or over time, and to discuss the results and treatment plan in a more relevant timeframe.
Analytes available at the point of service
Currently, there are greater than 130 analytes that can be assayed by a waived point-of-care device and, in addition, other non-waived analytes that can be performed at the point-of-service due to the availability of smaller, robust instruments. This expansion in analyte availability via POC testing has afforded many different specialties the ability to perform testing during an office visit. So, while greater than 70 percent of CLIA certificates are issued for performance of waived tests, it is not just waived analytes that are being tested at the point of service.
It is well known that the U.S. is experiencing an opioid crisis. The ability to perform waived screening when the patient is meeting with the physician is critical to monitor patient compliance. Granted, the immunochemical testing that is available is not as definitive as mass spectrometry (MS) confirmatory testing, but it can provide useful guidance to the clinician during an office visit, particularly when the visit is for a prescription refill.
In multiple chronic illnesses, the ability to have monitoring tests performed at the time of the visit is crucial to quality patient care. I mentioned opioids, but equally important is the availability of Hemoglobin A1C for monitoring diabetics, as well as a variety of other testing performed at the point of service to monitor other chronic illnesses. With laboratory results in hand, the practitioner and the patient can have an informed dialogue. This will enhance the value of the testing, since two-way dialogue between the patient and clinician enables greater patient education and patient engagement in their own treatment plan.
When results are telephoned to the patient after an office, visit they may well be left on voice mail or, if someone other than the clinician telephones the results, the person calling may not be able to answer patient questions. Also, keep in mind some patients may not return for a follow-up visit and the results may never be communicated to the patient leading to delay in treatment.
We should not overlook the diagnosis of infectious diseases. The availability of immediate testing when the patient first presents for care potentially will lead to a shortening of recovery time because therapy can be rapidly initiated. This is witnessed in the diagnosis and treatment of group A Strep and influenza infection, among many others.
Our healthcare systems are making a gradual transition from fee-for-service to a model of value-based care. Value, in turn, mirrors population health improvement with its emphasis on timely and preventive care. A basic example is the management of patients with diabetes. If the population of diabetic patients is effectively managed, and diabetic complications decrease, there will be a decreased overall cost for treatment of the diabetic population.
When this occurs, complication rates are improved, with decreased numbers of emergency department visits, decreased hospitalizations and decreased progression to cardiac disease to name a few promising outcomes.
In the value-based model, the cost of laboratory testing in the treatment of chronic illnesses becomes less a financial issue, as financial incentives are factored into reimbursement for achieving quality goals. Value-based care is more meaningful for the patient when they experience enhanced quality of life. Society benefits from the overall reduction in cost of medical care. In the end, the quality programs with the goal of timely, appropriate testing and treatment of patients with chronic illnesses make everyone a winner: the patient, the medical practice and society.
Role of consumerism
The role that consumerism plays in medical laboratory care today cannot be overstated. With the availability of “Dr.” Google, patients seek to play a more active role in their healthcare, and prefer that testing be performed at the time of the face-to-face meeting with the provider so their questions can readily be answered and treatment plans developed based upon the most current information. Just consider the positive reception that online patient portals have received.
The experience of the American Association for Clinical Chemistry (AACC) website “Lab Tests Online” is very telling. This site provides patient information concerning the utility of several hundred laboratory tests and multiple disease conditions. Since its inception in 2001, over 325,000,000 views have been logged. Patients are consumers – they want information about their diseases, and they want one-stop shopping. There is immediacy in their desire for diagnosis and care. Online, they have access to learn best practices and to look for best practices in their providers. Point-of-care testing is certainly a best practice known to our patients.
With multiple analyzers available to perform testing of 130 different waived analytes, plus the availability of small instruments to perform moderately complex POC testing, we need to evaluate our patient populations for the commonly ordered laboratory tests currently sent to a reference laboratory. The available instrumentation and its cost, coupled with the realistic test needs of our patients, will assist in reaching a decision on the most practical approach to point-of-care testing in your facility.