The Journal of Healthcare Contracting

Front Lines
POC in the ER? As point-of-care technology expands, more hospitals adopt rapid testing programs
by Laura Thill

Editor’s Note: The participation of those in the following article does not constitute an endorsement of the sponsor’s products or services.

Taking their cue from physician practices, hospital-based physicians, lab directors and clinicians are increasingly recognizing the value of point-of-care testing in hospital settings. Although patient population and cost continue to influence which hospitals are likely to purchase which tests, overall acceptance appears to be on the upswing.

In the last three years, administrators have seen an increase in point-of-care testing at hospitals, according to Fred Halvach, senior vice president of pharmacy services at Broadlane (Dallas, Texas) and Martin McBride, senior director of pharmacy services. "However, the type of testing and location of performing the tests is highly variable due to the differences in patient conditions and disease states," says Halvach. "Hospitals must evaluate the various point-of-care (POC) devices for their patient population. This requires a multidisciplinary approach with laboratory technologists, physicians, nurses and hospital administrators." Particularly as organizations such as the Centers for Disease Control and Prevention and the National Institutes of Health work to increase public awareness of preventing the spread of infection, more hospitals "seek value in defining the severity of patient disease states," he adds.

"Hospitals are trying to get a greater understanding of patients as they come in the door," says Ed Gravell, vice president of marketing management at Cardinal Health (Dublin, Ohio). "They are looking to screen patients, and either isolate or treat them immediately, and this is driving point-of-care testing. [And while] it’s important to get testing closer to the patient, we must also consider the cost, relevancy, turnaround time and complexity of a test."

The increasing accuracy of rapid tests has also helped to drive the hospital market, according to Barbara M. Maillet, senior director, laboratory services, Premier (Charlotte, N.C.). "I think point-of-care testing is certainly becoming more prevalent in hospital settings, because it correlates so well with lab testing and [because of] the increased specificity and sensitivity of test results as compared with lab results."

The emergence of hospital rapid testing began with bedside glucose testing and pregnancy testing in the ER (to confirm that patients are not pregnant prior to being exposed to radiation), according to Gravell. Today, the list has expanded to include cardiac markers to evaluate heart function and, in some cases, testing for Methicillin Resistant Staphylococcus Aureus (MRSA). Examples of hospital-based rapid tests include:

Blood Urea Nitrogen (BUN)
Serum Creatinine (SCR)
Electrolytes
Hemoglobin and Hematocrit
Cardiac markers (e.g., Creatine Kinase, Creatine Kinase-MB and troponin)
B-type Natriuretic Peptide (BNP)
Hemoglobin
Albumin
White blood count
Prothrombin time.

Gastrointestinal rapid tests also are becoming more widely used in hospitals, according to Corey Case, senior product manager, Cardinal Health. "And, flu and strep testing are becoming more prevalent as well," he says. "Rapid flu testing [accounts for] a huge volume for us from a distributor perspective.

"Of course, cost is always an issue [with regard to] point-of-care testing," he continues. "But, so is ease-of-use." So, tests such as flu and strep, which can be completed by a nurse or nurse aid are becoming increasingly prevalent in hospitals, he adds.

MRSA testing is becoming more prevalent, too, especially as concerns about it have grown among both clinicians and the public at large. Still, the most rapid test currently available is a two-hour molecular test or a manual microbiology test with 24-hour turnaround. "If there becomes a future test for MRSA with [more] rapid turnaround, there very well may be increased use among hospitals," says Maillet. But, the cost of the test would be a big factor in how quickly it catches on, she adds. She also anticipates expanded use of cardiac markers in the hospital setting. "As more cardiac markers are identified, they probably will be used in hospitals," she says. "Premier is looking to expand its current offering of test kits."

One hospital joins bandwagon
At Doctor’s Medical Center (Modesto, Calif.), Terrell Chambers, MBA, CLS, MT (ASCP), director, lab services, and his supervisor, Nav Sharma, CLS, MT (ASCP), are exploring opportunities in point-of-care testing. However, they are selective in their choice of tests. "We have added more testing capability, [including] Rotavirus and coagulation," says Chambers. "We have also expanded our waived metabolic panel and added it to our rapid response team." In addition, the hospital has added a device, which enables open-heart surgeons to titrate heparin.

Chambers acknowledges his hospital’s need for more cardiac testing, but is hesitant to add this due to the lack of standardization between point-of-care and lab cardiac tests. "Particularly in the case of BNP and troponin [which are used to diagnose heart failure], the rapid tests run on different platforms from our lab tests," he points out. Other rapid tests, such as glucose, don’t present this issue, he adds.

In other cases, Doctor’s Medical Center’s decision to add a test boils down to its cost-effectiveness. For instance, the state of California requires hospitals to screen certain populations for MRSA, Chambers explains. "We investigated the two-hour test, but it was too expensive and we opted to add the 24-hour test. If a more rapid test that is cost-effective becomes available in the future, we may explore it. But, we are pleased with our current system for testing MRSA."

Lab accountability
While cost is an issue that sometimes prevents hospitals from adding new tests, it is not the only issue. Hospital labs are responsible for quality assurance and training of users of point-of-care devices. "Hospital lab directors are responsible for all lab results, including point-of-care testing [that is not CLIA-waived]," says Maillet. "So, if [complex] point-of-care testing is being done in the ER or intensive care unit, and no one in those units has their CLIA certificate, then that particular testing is completed under the lab’s CLIA certificate, [making] the lab director ultimately responsible for the end test result."

When the lab director lacks oversight over the staff or clinicians who may be running a particular test, he or she is placed in a compromising position, Maillet continues. However, hospitals often have protocols in place for ensuring the competency of staff running complex point-of-care tests, she adds. "And, there are many hospitals capable of providing excellent care without implementing point-of-care testing," she says. "[We are aware of] hospitals that have been recognized for their excellent care of cardiac patients without implementing point-of-care programs."

The future of POC
While not all hospitals have bought into the benefits of point-of-care testing programs, they may feel some pressure to come on board in the future. "Hospitals are challenged with competitors marketing shorter emergency department wait times," says Halvach. "The use of point-of-care devices could lead to decreases in the turn-around time of test results and [help ensure] prompt treatment of patients. As public awareness grows, it is likely our clients will request to have more of these products on contract."

Advances in technology should lead to a broader menu of point-of-care tests in hospitals, note Gravell and Case. They point to advances in molecular technology and biomarkers, as well as research around blood thinners. "As the technology expands, it’s safe to say we should see more point-of-care testing in hospitals," says Gravell.

Sidebar:
Talk the talk

Show your colleagues in the lab you know a thing or two about their business. Here are a few terms and tests you and your staff should be aware of, as described in the pages of Repertoire, a sister publication of the Journal of Healthcare Contracting, read by medical products distributors.

CLIA, or the Clinical Laboratory Improvement Amendments, are federal regulations controlling healthcare labs. The CLIA regulations divide testing into two categories: waived and non-waived. Waived tests are the simplest and can be performed by virtually anyone who can follow manufacturers’ instructions. Non-waived tests (called "moderately complex" and "highly complex") are more complex and require that the lab be inspected every two years.

Immunoassays are biochemical tests that measure the level of a substance in a biological liquid, such as serum or urine. An immunoassay relies on the reaction of an antibody to its antigen. Most rapid diagnostic test kits available today use a lateral-flow immunoassay test device, which includes a plastic housing for sample collection and at least one immunoassay test strip. Samples either are pre-treated with one or more reagents prior to contact with the test strip, or they are whole blood.

Helicobacter pylori, or H. pylori, is a spiral-shaped bacterium found in the gastric mucous layer or adherent to the epithelial lining of the stomach. It is the real culprit behind more than 90 percent of duodenal ulcers and from 50 to 80 percent of gastric ulcers. Today, antibiotic regimens can successfully eradicate H. pylori infection in most patients.

Infectious mononucleosis, or glandular fever, is caused by the Epstein-Barr virus, a member of the herpes virus family, and is found full-blown most commonly in adolescents and young adults. Tests for mononucleosis may not be positive until the patient has been infected for one week after onset. (It peaks at two to four weeks.)

Influenza, or flu, is a respiratory infection caused by a variety of viruses. The Centers for Disease Control and Prevention estimates that 10 to 20 percent of Americans contract the flu during each flu season, resulting in about 36,000 deaths. Rapid tests are available that can detect the presence of influenza A and B virus in a patient nasal wash or nasal swab sample within 10 minutes.

Strep throat is caused by Streptococcus pyogenes bacteria, which are most often spread through airborne droplets when someone with the infection sneezes or coughs. Most doctors order a rapid test to check for the presence of streptococcal bacteria. In addition, the doctor may choose to have the patient’s throat swab further tested at a laboratory, especially if the results of the rapid test are negative.

Lipid panel. Lipids are fat and fat-like substances used by the body as a source of fuel. They include cholesterol, triglycerides, high-density lipoprotein (HDL) and low-density lipoprotein (LDL). Lipid disorders are problems that affect the way cholesterol is produced, used, carried in the blood, or disposed of by the body. People who have lipid disorders are at risk of developing coronary artery disease, often at an early age. That’s why early detection is important.

Hemoglobin A1c. While blood glucose testing monitors day-to-day levels, the hemoglobin A1c test offers a longer-term view – anywhere from two to four months. The test measures the amount of blood glucose attached to one specific place on the hemoglobin molecule inside red blood cells. The higher the patient’s blood glucose, the more glucose the red blood cells accumulate.

Prothrombin time. When the body sustains a wound, the blood clots. Under normal circumstances, this is a healthy response, because clotting helps the body heal itself. But under certain circumstances (e.g., atrial fibrillation, deep vein thrombosis, pulmonary embolism, mechanical heart valves, etc.), this same mechanism can cause an unwanted and life-threatening clot or "thrombus" to form. Patients with these conditions must take oral anticoagulants, which decrease the clotting ability of the blood. Changes in patient health, lifestyle or diet can adversely affect the action of anticoagulants. That’s why patients taking them must be tested frequently to make sure they are taking the proper level of anticoagulants. This is the purpose of the prothrombin time test.

Trichomonas vaginalis is a microscopic parasite responsible for Trichomoniasis, the most common sexually transmitted disease. Five million new cases are diagnosed each year, but because symptoms are not always apparent, the true infection rate is estimated to be as high as 8 million each year. Trichomoniasis is associated with pre-term birth, low birth weight, increased risk of HIV transmission and cervical cancer. A rapid point-of-care test for Trichomonas is simple to run and provides results within 10 minutes.

Aspirin assay. An estimated 20 million people in the United States take aspirin to help prevent heart attacks and stroke. Of these individuals, up to 30 percent fail to receive adequate inhibition of platelet aggregation and hence remain at an increased risk of heart attack and stroke. A CLIA-waived aspirin assay allows the provider to determine on the spot whether patients are responding to aspirin or if they require an increased dose of aspirin or an additional drug therapy.

B-type natriuretic peptide (BNP). The BNP test is a rapid point-of-care immunoassay used to help diagnose and assess the severity of heart failure and risk for patients with acute coronary syndromes. The test is CLIA-waived for use with whole blood samples and produces a quantitative result within 15 minutes. Patients can be tested every three or four months to monitor how the disease is progressing.

Albumin-to-creatinine ratio (urinalysis). One in seven Americans has, or is at risk for, kidney disease. Early detection can result in more timely treatment as well as potential avoidance of costly dialysis treatment. A test for albumin-to-creatine ratio aids in the early detection of kidney disease.

Blood urea nitrogen (BUN); creatinine. BUN and creatinine are waste products that are filtered out of the blood by the kidneys. Increased concentrations in the blood may indicate temporary or chronic kidney disease, with decreased kidney function.

Human immunodeficiency virus, or HIV, is a retrovirus that leads to Acquired Immunodeficiency Syndrome (AIDS). The HIV infection is transmitted from one person to the next through bodily fluids. When HIV enters the body, it moves within white blood cells called CD4 lymphocytes. HIV takes over the CD4 cells and replicates itself over a billion times each day. The new viruses then spread through the body, which tries to defend itself by producing antibodies and macrophages (special cells) and T-cells. A rapid HIV test to detect antibodies to HIV can produce results in up to 20 or 30 minutes.

Basic metabolic panel (BMP) is often ordered in hospital settings and generally includes eight tests designed to monitor the status of a patient’s kidneys, electrolytes and acid/base balance, blood sugar and calcium levels. Significant changes in test results may indicate kidney failure, insulin shock, diabetic coma, respiratory distress or changes in heart rhythm. The BMP also is used to monitor hospitalized patients with hypertension or hypokalemia.

Comprehensive metabolic panels (CMP) generally include 14 tests, which help evaluate a patient’s organ function and check for conditions such as diabetes, liver disease and kidney disease. The CMP also may help monitor conditions such as hypertension, or kidney- or liver-related side effects to certain medications.