Every year, about 2 million Americans head to emergency departments (EDs) complaining of shortness of breath and chest pain that may signal acute coronary syndrome (ACS) and acute myocardial infarction (AMI). Therefore, point of care testing (POCT) has become a point of emphasis at Mercy Medical Center in Canton, Ohio.

Timing is critical. The faster an emergency team diagnoses ACS or AMI, the more of the patient’s heart muscle can be saved. As time goes by, costs go up. The faster tests are done, the sooner patients can be admitted or ACS symptoms ruled out, unnecessary testing eliminated, and treatment started.

At the core of Mercy Medical Center’s cardiac program is the Stratus® POC CS Acute Analyzer from Dade Behring. What makes the bedside analyzer test especially valuable is the support Mercy gets from Dade’s Clinical Quality Initiative (CQI) team, says Claudia Wilkins, laboratory POCT coordinator.

“Starting with the instrument itself, which is durable and reliable, we also get immediate, professional troubleshooting help from the technical hotline,” Wilkins says. “When necessary, we have quick access to field specialists who perform repairs on-site 24/7.”

The CQI team provides a high level of support, according to Wilkins. “There is a complete team of clinical specialists, sales specialists, regional managers, and customer service specialists who willingly assist us,” she says. “I find it remarkable how well this large team communicates with each other. Whatever problem we have gets addressed promptly.”

For cardiac patients, bedside testing can make the difference. It is difficult for central hospital labs to consistently meet American Heart Association (AHA) and American College of Cardiology (ACC) standards calling for treatment within 60 minutes of patients entering the ED. But Mercy’s cardiac POCT program meets the standards, with time to spare.

“About 8 years ago, our clinical laboratory reorganized and restructured in an attempt to become more efficient and do more with less,” Wilkins says. “As a result of this process, a number of full-time employees became available and new lab positions were created to better manage the changing world of laboratory medicine.” She filled one of the new positions.

As POCT coordinator, Wilkins is the only lab-staff member assigned to this area. Actual POCT is performed at, or near, bedside by nursing-unit personnel. In total, about 900 different individuals throughout Mercy perform bedside testing. Recently, the lab hired another phlebotomist to work in the ED to meet patient care needs.

It is Wilkins’ job to maintain supply inventory for all POCT; to oversee quality control, instrument care, and maintenance; and to ensure that all regulatory requirements are satisfied. She is responsible for education, in-service, and general support for all POCT staff.

Mercy Medical Center’s POCT Program
Mercy’s POCT program is extensive and growing. About 13,000 times per month, staff perform bedside glucose testing of patients. Other common POC tests are cardiovascular related and administered to 1,655 patients in a typical month. These tests include the activated clotting time (ACT), Troponin-I, D-dimer, and Thromelastograph; most are administered on ED patients.

A registered medical technologist, Wilkins joined Mercy Medical Center in 1977 after a stint with the Peace Corps in Ecuador. Nationally known for its cardiac center, Mercy also earned distinction as the first chest pain center in the country to win full accreditation from the Society of Chest Pain Centers.

“It is well known that each time something changes hands, there is potential for delay. This is even more true when it also involves changing actual hospital departments—such as between the emergency department and the laboratory,” Wilkins says. “Avoiding delays helped make cardiac POC testing a point of interest for us. It meant the blood sample would never leave the ED—the ED could perform its own cardiac testing using its own staff and its own instruments.”

The 476-bed hospital first considered cardiac POCT 9 years ago. The lab and the ED agreed on the importance of accurate Troponin results. Emergency physicians placed great emphasis on the need for rapid turnaround times (TAT), while the lab’s view was colored in large measure by the regulatory-compliance issues, Wilkins says.

After careful review, Mercy Medical Center chose the Stratus CS Acute Care ™ Diagnostic System from Dade Behring. “The only instrument that met all of these requirements was the Dade Behring Stratus CS. Because of its continual operational surveillance, the system provides quality results, rapid TAT (14 minutes), is user-friendly, and has many lockout capabilities that enforce protocol,” Wilkins says. “These electronic features, plus Telcor connectivity, enable us to maintain regulatory compliance.”

Frank Kaeberlein, MD, chairman of the ED and codirector of the Mercy Chest Pain Center, offers an insider’s perspective on using the Stratus platform. He sees a number of advantages to the bedside cardiac testing:

• The rapid TAT for cardiac markers improves patient processing, since patients spend less time in ED beds awaiting lab results.

• The improved throughput results in better length of stay; with more open ED beds, fewer patients leave without treatment (LWOT).

• Lower LWOT rates clearly translate into higher total ED charges, because more patients are being seen and treated.

“Compared to a main lab cardiac marker, we are probably saving at least 30 minutes of time with each POC Troponin-I, and that translates into a huge amount of time savings because of the total volume of patients who need cardiac-marker testing,” Kaeberlein says.

When incorporated into a well-designed ED care path for managing patients with chest pain, POC cardiac-marker testing rapidly identifies patients with AMI and allows accurate stratification of all other patients into groups at high, low, or no risk for ACS, Kaeberlein says.

“Accurate stratification enables us to precisely identify those select patients who actually need an expensive cardiac care unit bed, while the rest can be placed in a regular monitored bed or safely sent home,” he says. This accurate identification of patients at risk for ACS has resulted in Mercy reporting a record low 0.2% rate of missed AMI.

“In addition, our POC D-dimer testing, in conjunction with a set of probability rules, allows our ED staff to rapidly identify patients for whom pulmonary embolus or deep venous thrombosis can be safely ruled out with only negative D-dimer results,” Kaerberlein says.

This approach enables the hospital to safely send patients home without the time and cost associated with additional imaging studies; a single, simple blood test is far more cost- and time-efficient than a duplex study or computed tomography scan, according to Kaeberlein. “This again frees up ED beds more quickly, since our D-dimer turnaround time is less than 30 minutes.”

Dade Behring’s Support
Dade Behring’s CQI team consists of 18 consultants reflecting a variety of health care professionals directly involved in the diagnosis and treatment of patients. Included are nurses, physician assistants, emergency medical technicians, and medical technologists. Together, they provide an extensive knowledge base for directly supporting customer laboratories and EDs.

Jeff Thomas, director of the CQI team, says the initiative serves as a “go-to” resource that 5 years ago would not have been nearly as effective, because at that time, cardiac POCT had limited clinical and financial supporting data. Process integration and POCT training then were not what they are today.

“Today, our team still holds a unique position in cardiac POC testing, combining a wealth of consulting expertise with a point of care testing system that has a Troponin assay that meets the AHA/ACC guidelines for sensitivity, specificity, and turnaround time,” Thomas says. He says there is no incremental charge associated with CQI team support for the Stratus CS Acute Care™ Diagnostic System.

In the past year, the Stratus CS Troponin I assay received clearance from the US Food and Drug Administration (FDA) as a high-sensitivity Troponin method, making it the first FDA-cleared high-sensitivity Troponin I POCT/NPT method. NT-ProBNP was also cleared by the FDA and launched in 2005 on the Stratus CS platform. The full menu of Stratus CS assays also includes CKMB, Myoglobin, bHCG, and D-dimer. The CardioPhase hsCRP assay is now under development.

Registered Nurse Amy Cotner, who serves as CQI team manager, says the team offers consultations that are customized to individual facilities. “Depending on customer needs, our team may be engaged for weeks or for much longer,” Cotner says. “In every case, the consultation is based on knowing our customer and developing a long-term relationship with them.”

Once assigned, the CQI team provides support to customers on an ongoing basis. Usually, that involvement encompasses training assistance and the sharing of the latest information on trends, protocols, and technology.

Cotner says each facility with a Stratus CS system receives an annual in-service program on ACS. The CQI team helps the customer take diagnostics a step further by supporting the clinical education, process improvement, protocol assessment, and multifunctional integration that drive quality patient care and successful financial performance.

Nicholas Borgert is a contributing writer for Clinical Lab Products.