Point-of-care testing (POCT) has become an important part of patient care at many health care facilities. Some institutions, however, simply maintain a POCT program and do not develop it to its fullest potential. 

Mark Barglowski, MBA, CLT, MT(ASCP), director, Laboratory and Respiratory Care Services, Providence Saint Joseph Medical Center, Burbank, CA, began the presentation by discussing the challenging approach his lab took to promote the highest level of impact for patient care and the 420-bed hospital with POCT. He outlined the lab’s strategic approach, which involves active communication for POCT users and other key hospital individuals to allow for growth in a lab-based POCT program outside of lab boundaries.  For the rest or this article, click here.

Cap Today, September 2003 Feature Story
In Two Settings, Plusses Pile  Up for POC Coag Testing

By Karen Lusky

In the real world, point-of-care coagulation testing and treatment algorithms are as close as it gets to that imaginary ideal, though everyone agrees the POC devices are far from perfect. Yet a growing number of studies show that the point-of-care approach appears to produce impressive clinical and cost outcomes in cardiac surgery and outpatient anticoagulation clinics.

“Rapid turnaround time for coagulation tests guides surgeons in controlling surgical bleeding and in avoiding unnecessary blood transfusion,” says Haifeng Mark Wu, MD, assistant professor of pathology and director of the clinical coagulation laboratory at Ohio State University, Columbus. 

Dr. Wu’s laboratory is considering using POC coagulation testing for cardiac surgery and organ transplantation in its new Ross Heart Hospital. “Without POC values, over-transfusion tends to occur in surgery,” he adds. “And everyone understands the importance of saving blood. Not only are blood components invaluable products that cost our hospital alone $10 million a year, it’s best for patients to avoid unnecessary transfusions.” For the rest or this article, click here.

With autumn’s approach, it seems time to shake off the frivolities of summer and get back down to business. And it looks like blood gas analyzer manufacturers are following suit: With a host of features, manufacturers aim to demonstrate that their commitment to streamlining the analytical process is serious business indeed.

Since Medica has a strong presence in the international market, he points out, “we can’t have people flying to Russia to service a machine. We try to keep things very simple, very intuitive. We think the future is eliminating on-site service.”

This minimalist approach is also behind the company’s decision to limit the number of analytes in its menus. “I think the trend is towards putting more and more analytes in a single array,” Moe says. “The downside to that is, the cost per test is higher because of the technology required to make those arrays. We’ll add analytes, but we won’t do it at the expense of cost per test."

For the rest of this article, click here.

Advance for MLP - POCT Series Part 1:
Instrumentation Selection

Today’s POC technology promises to deliver quick, simple, portable, user-friendly and reliable test results, but proper instrumentation selection goes a long way in delivering on that promise. 

This series is running in Advance for Medical Laboratory Professionals.  To subscribe to this publication, click here.

CAP Today, June 2003
Feature Story
POC in Motion-the Changing Face of Mobile Testing
By Karen Southwick

The future of point-of-care testing could yield a wide array of options for consumers, clinicians, and labs, including one possibility that could drive out the central laboratory almost entirely. Widespread POC testing “would be the final triumph of consumerism,” says Larry Kricka, DPhil, professor of pathology and laboratory medicine and director of general chemistry, University of Pennsylvania Medical Center, Philadelphia. “This vision would perhaps see the demise of the central lab.” Thanks to microchip technology, he says, we might all carry a “personal laboratory” in our pockets that can monitor clinical indicators.

Dr. Kricka and other experts participated in a March and April audioconference series presented by the American Association for Clinical Chemistry, which covered subjects ranging from the future of POC testing to using brain natriuretic peptide and troponin at the point of care. Widespread POC testing would require social, technological, and regulatory changes, Dr. Kricka says. POC testing is already expanding beyond the hospital, into physicians’ offices and the home. 

As micro technologies shrink the instruments needed for tests, consumers will do more of the tests themselves, and the results will be transmitted to physicians. Further into the future are implantable microlab devices.  Personal laboratories, however, will not become commonplace unless they are convenient to store and to use. In particular, “people won’t want to stick themselves to provide specimens,” Dr. Kricka says, so less-invasive technology will be needed. In addition, consumers want “all-in-one tests,” for which they simply add a substance to produce a result.

For the rest of this article, click here.

CLN’S LAB 2003
Connecting to the Future
POCT: Challenges of the
Post Connectivity Era
By Jay Jones, PHD

The growth in point-of-care testing (POCT) continues to be fueled by the expectation that future devices will be connected to POCT data managers, laboratory information systems (LIS), and electronic medical records (EMR), improving both patient management and reimbursement for tests. 

Moreover, since the National Committee for Clinical Laboratory Standards (NCCLS) published point-of-care testing (POCT) connectivity standards in 2001, vendors and users of POCT devices have increasingly partnered to integrate these devices into the information systems of health care systems, creating a wealth of POCT data.  

These standards, developed by the POCT Connectivity Industry Consortium, form the foundation for a set of "plug-and-play" POC communication standards that allow seamless information exchange between POCT devices, EMRs, and LISs.

The question that many laboratorians may be asking today is: 

Where does all of the data go?

The short answer is to data-bases in numerous existing information systems. However, not all databases are created equal and interfaces to multiple existing information systems can be quite complex. It is important for laboratorians to understand what benefits and burdens come with POCT connectivity.

For the rest of this article, click here.

Error Prevention Systems

Implementing combinations of security, validation and performance systems (based on the U.S. survey) helps prevent errors. For example, a nurse assigned an intermediate access level performs testing (validation system) after accessing instrument operation with a PIN and password (security system), but also must follow QC protocols (performance system) before testing patient samples (overlap in the Venn diagram center). In contrast, a validated assistant who only reviews results enters a PIN for access, but omits QC testing since no patient testing is performed (overlap of two systems toward the top).

System options allow the POCT coordinator to select and set criteria for operator lockout, such as nonvalidated operator (NVO), noncertified operator (NCO), no QC performed (NQC), no data transferred (NDT) and no patient identified (NPT):

• NVO–Protects the POCT program from unauthorized and inappropriate use of POC instruments.

• NCO–Prevents testing if the operator lacks education, experience or current skills appropriate for the setting.

• NQC–Prevents testing if the QC protocol for the instrument is not followed or if QC is not performed in a timely fashion.

• NDT–Assures the integrity of the medical record and facilitates several other functions, such as monitoring patient data, checking QC compliance and tracking instrument errors.

• NPI–Prevents testing if the patient has not been positively identified and avoids patient misidentification.

Recommendations

The minimization and elimination of the sources of error listed in the The minimization and elimination of the sources of error call for appropriate professional knowledge. Manufacturers must make the "human factors" systems available on POC instruments so that POC directors and coordinators can manage programs properly. The use of these safety options will help implement the total quality principle and will decrease the costs of preventing, detecting, tracking, reducing and correcting medical errors in POCT.

Dr. Kost is director of Point of Care Testing Center for Teaching and Research; professor of Medical Pathology, School of Medicine; director of Clinical Chemistry, UCD Health System; and on the faculty, Biomedical Engineering, at the University of California, Davis. He also is an ADVANCE editorial advisory board member.

References

1. Kost GJ. Preventing medical errors in point-of-care testing: Security, validation, performance, safeguards, and connectivity. Arch Pathol Lab Med 2001;125:1307-1315.

2. Kost GJ. Controlling economics, preventing errors, and optimizing outcomes in point-of-care testing. In: Kost, GJ., Ed., Principles and Practice of Point-of-Care Testing, Philadelphia: Lippincott Williams & Wilkins, Chapter 40, 2002.

3. Kost GJ. Understanding and preventing medical errors in point-of-care testing (and the use of FAST-QC). In: Nichols, JH. Point-of-Care Testing: Performance Improvement and Evidence Based Outcomes, New York: Marcel Dekker, Chapter 4, In Press.

When to require compliance with health care information technology (IT) standards is one of the more vexing but important problems that hospitals and laboratories face today. For vendors, the dilemma of what standards to support with which products is scarcely less daunting.

A wise choice of standards can reduce total product, integration and support costs and can provide a platform on which higher level value-added functionality (e.g., clinical outcomes or disease management services) can be developed and deployed. Unfortunately, choosing appropriate standards often is not straightforward. As has been observed, the beauty of standards is that there are so many.

The subject of health care IT standards could be debated forever, but a few simple observations and rules can help to simplify the landscape and provide a basis for evaluating how (and which) standards fit into product and purchase decisions.

When Standards Can Help

From a vendor's perspective, standards are most frequently of benefit when they reduce the cost of integration. If a vendor's product is used as part of a customer's complete solution, communication standards can lower the product's integration cost. This situation is often the case in the medical instrumentation marketplace, where vendors are rarely principal suppliers of both instruments and comprehensive information systems.

Consider how vendors of laboratory instruments and information systems have employed ASTM and HL7 standards to greatly lower the interoperability barrier. Although none of these standards provide a "plug-and-play" experience (all require some setup and pre-installation configuration), they have simplified the historical problem of connecting laboratory systems that used vendor-specific protocols.

Similarly, the imaging and radiology marketplace has benefited from the multi-vendor interoperability provided by the DICOM standard. Also, the IEEE 1073 and NCCLS POCT 1-A standards now enable multi-vendor interoperability at the point of care.

Indirectly, customers realize benefits from successful standardization through lower product, integration and maintenance costs. More directly, customers benefit from the additional effort and resources vendors can now devote to value-added functionality once the issues of cables, wires and protocols are standardized.

The Ethernet standard provides a great example of these industry-wide benefits. Once computer system vendors chose to standardize on Ethernet over the many different proprietary cables and protocols, they were freed to concentrate on higher-level networking functions, which led to client-server computing, the Internet and the Web.

When Standards Don't Help

Not all standards have succeeded in the marketplace, and standards are not the best option in all situations. Understanding the relationship between standards and interoperability is key to recognizing why some fail.

Although standards are often the key to enabling multi-vendor interoperability, standards do not guarantee interoperability, and interoperability does not require standards. This proposition appears counterintuitive, since standards are usually developed to enable interoperability.

Several phenomena can contribute to the first argument–that standards don't guarantee interoperability. A standard may not address all of the technical issues that are the true impediments to interoperability. For example, a standard that defines message content but doesn't address lower-level physical protocols will not address customers' needs for plug-and-play interoperability.

In other cases, there may be too many standards for vendors to build interoperable solutions. Ironically, most vendors may be "standard compliant" in this case, but their solutions may not interoperate because they support different standards. Health care IT standards bodies have become more aware of this danger over the last five years, and several have formed alliances (e.g., HL7-IEEE 1073 Joint Working Group) or industry consortia (e.g., Integrating the Healthcare Enterprise) to define and demonstrate inter-standard interoperability frameworks.

The second half of the proposition–that interoperability doesn't require standards–may be true when a single vendor holds a dominant position or market share. Vendors may be able to build components that interoperate with the dominant "de facto standard" solution. This situation is not generally the case in health care IT, as few vendors can supply complete device and information management solutions. However, in cases where there is a de facto standard, the best option may be to aim for interoperability with the dominant platform, then advocate for vendor-neutral standards as the market matures.

Standard(s) Misconceptions

It is worthwhile to note two common misconceptions that are sometimes used as arguments against standardization. One argument is that standards will eliminate competitive advantage. The root of this misconception lies in the fact that companies often perceive all areas where they compete as areas of competitive advantage.

In particular, the proliferation of vendor-specific integration protocols often slows down the development of industries as a whole. The computer industry has clearly learned this lesson; witness the near universal adoption of the TCP/IP, WiFi and Bluetooth wireless networking standards. Similarly, the development of radiologic picture archiving and cataloging systems (PACS) owes much to the emergence of DICOM as a vendor-independent means to retrieve image data from imaging devices. Finally, laboratory medicine has benefited from the ASTM and HL7 standards, and is poised to take advantage of the IEEE 1073 and POCT1 standards in the evolving point-of-care testing environment.

The other common misconception is that if a vendor supports a standard, they will lose the ability to provide proprietary functionality. In fact, most health care informatics standards contain explicit means for vendors to extend the standard protocol for vendor-specific communication. For example, the HL7 messaging scheme provides a means to extend standard messages with vendor and local customization information. Also, the POCT1 standard contains specific extension mechanisms that vendors can employ to conduct entirely proprietary exchanges within the standard communication link.

How To Choose

When evaluating a vendor's support for standards, customers should inquire not just about whether a particular product or model complies, but also to what extent the vendor's entire product line is standards compliant. This test can help differentiate between vendors who have made a strategic commitment to a standard from those who might be more opportunistic and less dedicated..Vendors will respond to this commercial pressure and, in turn, will develop and support standards that benefit the entire industry.

Jeff Perry is principal, Walker Informatics, Palo Alto, CA.

Advance for Administrators of the Lab Vol. 11 • Issue 8
Expanding, Exceeding POCT Boundaries
By Stephanie De Ritis 

The POCT universe is getting larger. New-and-improved technologies are upon us, so it is important to know what coordinators need to make the best possible health care available.    Anxiety builds as the young woman waits. She paces until she realizes that it is time to inspect the small dipstick for a plus or minus sign. Negative. Relief sweeps over her face. The puzzle that could have cost this woman weeks to solve has been uncovered in less than a few minutes. Not surprisingly, she is unaware that she is one of many that are contributing to the boost in point-of-care testing (POCT).

It was more than 15 years ago that POCT technologies swept the medical industry starting with the glucose meter.¹ The industry has grown considerably since then. In fact, POCT is expected to grow rapidly in the next 10 years. Why is this? Just like the woman waiting for her pregnancy test results, there is a growing need for fast results to provide appropriate treatment.

Connectivity

New technologies are the result of the demands of the industry. For example, one advance that point-of-care coordinators (POCC) are looking to implement in their facilities is "plug and play" connectivity options, says Kent B. Lewandrowski, MD, PhD, associate director, Clinical Laboratories, Massachusetts General Hospital, Boston; associate professor, Harvard Medical School; and editor of Point of Care: The Journal of Near-Patient Testing. Connectivity is extremely important, not only to make life easier for the operator, but also to help meet regulatory measures.

"The most important thing that connectivity would do is [help connect all of the different instruments that are scattered throughout the facility]," says Dr. Lewandrowski.  He explains that to interface just one family of instruments throughout a hospital would cost the facility too much. Also, to have it all connected to the laboratory information system (LIS) as well as other management systems would be very expensive. This is the reason that Dr. Lewandrowski recommends the plug and play scenario. With this, there would be no need for information technology personnel to hook up all of the instruments.  "It should be as simple as taking a telephone out of my wall and plugging it into yours and it would still work," Dr. Lewandrowski describes.

With the help of the Connectivity Industry Consortium standard that was developed in 2000 and approved in November 2001 by NCCLS, devices will need to be compatible with all connectivity packages. The POCT 1-A provides engineers specifications to create standardized interfaces for devices, workstations and clinical information systems that will allow multiple types and brands of POC devices to communicate with access points, data concentrators and LISs.²

According to Christopher Fetters, founder and president of Nextivity, Spring Grove, PA, the purpose of the standard is so that you can take a device into any hospital, plug it into the wall and it will self-identify itself onto the network and send its data to whatever data manager you have. He admits that this may take some time for the concept to become a reality, but the standard is bringing facilities closer to it.

Not having a full connectivity package can hinder some of the daily activities that need to be performed. Duties may not be implemented effectively. For example, it is difficult to adhere to regulatory compliance when you do not have full connectivity.

According to Dr. Lewandrowski, connectivity will allow you to assemble the necessary data that has to be documented for regulatory compliance, such as who did the test; when it was completed; whether quality control (QC) was done; whether a trained operator performed the test and, if not, if there is lockout; and what types of strips for reagents were used.

"As of right now, in some places, all of these issues are being maintained manually, which results in a large amount of paperwork," Dr. Lewandrowski says. "If you have all of this paper, you are not going to implement successfully POCT technologies because you won't be able to oversee all of the regulatory information."

Fetters agrees that not having the proper connectivity is slowing down the entire marketplace. He says that people are holding out on purchasing a data management system because they are not sure to what products a certain company's system will connect.

Diana DeHoyos, BSMT(ASCP), POCC, University of Texas Medical Branch, says there have been advances in "vendor-neutral" connectivity packages as well as devices that can perform multiple duties. She says POCT technology is expanding to incorporate features such as the availability of platforms to result manual tests–patient and quality control. Although these vendor-neutral packages are ideal for facilities, some of them are not fully vendor-neutral, Fetters explains. They may connect to more than one system; however, they may not connect to all systems.

Additional Advances

Non-Invasive Methodologies

For patients suffering from diabetes, non-invasive methodologies would be more than a godsend. There is presently a minimally invasive product available to measure glucose–the GlucoWatch (Cyngus Inc., Redwood City, CA). The instrument attaches to the wrist of the patient and performs glucose measurements every 20 minutes on fluid collected by iontophoresis.^3,4

With this advancement, there would be no need to take a blood sample from the patient. According to Dr. Lewandrowski, some of these instruments can take the measurement by contact of the device with the skin's surface. He believes that a non-invasive methodology for glucose will be developed in the near future.

For those that need to test for bilirubin, however, the device already exists. The BiliChek Noninvasive Bilirubin Analyzer is manufactured by SpectRx, Norcross, GA, and sold in the United States by Respironics, Murrysville, PA.⁵ To perform the operation on an infant, the user needs to place the tip of the unit near the infant's forehead. This causes no pain for the infant and eliminates the use of blood sample products."The problem with these instruments is with the accuracy," Fetters notes. "The CVs from blood as opposed to CVs with electrical impulses on the skin can vary. [It will take some time before this is fully developed]."

Menu Expansion

Another inevitable advance, says Dr. Lewandrowski, is the expansion of the POCT menu. There are many new items on the rise, including influenza testing, BNP and D-Dimer testing, and also the use of creatinine as part of the basic metabolic panel.  "It is really a technology issue," says Dr. Lewandrowski. "Five years from now there will be many more broad technologies that are capable of effectively and efficiently performing a number of different lab tests."

Home Tests

Consumers have the ability to perform laboratory tests in their own homes with the explosion of home tests that include urine pregnancy, drugs of abuse, occult blood, ovulation and cholesterol. 

Clinical Laboratory News
Urinalysis -How to Create an Effective POC Program
By Elizabeth E. Porter, MT, ASCP

One could argue that urinalysis is the oldest of all point-of-care tests (POCT).  According to medical history books, ancient physicians such as Hippocrates recorded observations of urine to diagnose disease in the fifth century B.C., long before the existence of clinical laboratories. 

It wasn’t until the twentieth century that the scientists developed the first reagent strips for urine testing, making POC urinalysis the first modern day test of this kind.

Today, POC urinalysis testing is performed in many settings outside the clinical lab—on nursing floors, in clinics, and in physician offices.  As laboratorians work to develop institutional POCT programs, it is clear that many non-laboratorians who rou-tinely conduct this test are not aware of the important regulatory compliance or quality issues. In fact, the old adage, "a little bit of knowledge is a dangerous thing,"frequently applies. 

In order to produce relevant, high-quality patient results while main-taining compliance with applicable regulations, numerous factors should be considered. Here we describe how laboratorians can accomplish these goals while facilitating a win/win situation for everyone involved.

Click here for the rest of this article.

Clinical Lab Products, Vol. 31 • Number  6
POC Connectivity Driven by Customers
By Louise Lazear

The use of point-of-care laboratory instruments has grown largely due to the drive to improve patient care: faster results mean faster treatment decisions, particularly in critical care situations. 

Innovations in instrument technology have propelled the market as well, creating the acceptance of and need for testing at the point of care in a variety of settings. According to some estimates, the portion of IVD testing performed outside of the central lab will grow to 45 percent by the year 2008 worldwide. But with this opportunity comes challenge: how to control and maintain the quality of central lab testing at remote sites and meet regulatory requirements, and how to incorporate results into the patient record. 

Faced with a myriad of instruments with proprietary communications standards and the expense of designing multiple interfaces to existing LIS and HIS systems, POC device users spearheaded the push to POC connectivity.

According to a 1999 survey of 510 hospitals conducted by Enterprise Analysis Corporation (EAC), satisfaction scores for data management and connectivity were the lowest of all categories polled, including accuracy and ease of use of POC devices. Incorporation of POC testing into the LIS and HIS has become a front-burner issue.

New standards
Recognizing the need for and value of POC connectivity, the AACC’s POC Testing Division sought to define the problem and bring together stakeholders to develop a solution. In 1998, the division’s Industrial Liaison Committee called an open meeting of POC manufacturers, LIS companies, and POC users, eventually culminating in the formation of the Connectivity Industry Consortium (CIC) in February 2000. Composed of a group of vendors including Roche Diagnostics, Radiometer, i-STAT and Instrumentation Laboratories, as well as healthcare providers and professional organizations, the CIC was charged with developing open industry-wide connectivity standards for POC devices following protocols successfully utilized in the development of hospital software integration standards.

In a remarkable effort, the CIC finalized the standards and placed them under the under the purview of NCCLS, a standards development organization with extensive expertise in issues regarding the clinical laboratory. In December 2001, NCCLS released the approved standard as document POCT1-A, providing the framework for design of POC devices, workstations and interfaces to communicate bidirectionally with LIS and other systems in a vendor-neutral environment.

“The goal of the standard is to make every POC device ‘plug and play’,” said James Nichols, Ph.D., medical director of clinical chemistry at Baystate Health System (BHS), and founding member of the AACC POC Division. “From a consumer’s standpoint, one would like to have all (POC) device results integrated into the central laboratory information system and into the HIS. The problem is that many of these devices were developed for outpatient settings, and then were found to have applications in the hospital. And in finding those applications, they became subject to CLIA, which developed into a drive to collect the total cycle of data required to meet regulatory guidelines,” he said. 

According to Nichols, the NCCLS standards will allow hospitals to streamline current POC operations as well permit easier integration of new or additional POC devices, including those vendors pursuing web-based and wireless connectivity. Additionally, connectivity serves to capture billing as well consistency in documentation, which is important in monitoring trends in patient care liability protection. “Although regulatory issues drove the need for connectivity, billing capture is an added advantage that justifies the expense. Much of POC testing is performed for acute management of inpatients, and many of these tests are reimbursed as part of a DRG, a flat fee for a single patient admission. Despite the lower potential for recovery, it is important from a resource management aspect to monitor what tests are being done, and how many.”

This complete article can be found in the June 2002 
issue of Clinical Lab Products, or currently at http://www.clpmag.com/departments.ASP?Dept=C0206IA.

Cap Today, June 2002
How Top-Notch POC Programs Earn High Marks
by Karen Southwick

When point-of-care testing first surfaced more than a decade ago, laboratories figured if they ignored it, it might go away.

How times have changed. Today, laboratories are not only learning to live with point-of-care testing but also taking charge of it. "We found that we need to be actively involved no matter where testing is performed," says Peter J. Howanitz, MD, director of laboratories and vice chair, Department of Pathology, State University of New York Health Science Center. He also chairs the CAP's Point-of-Care Testing Committee.

POC testing has been good for labs, in fact, because its growth has forced them to build bridges with nursing and other units, says Kent Lewandrowski, MD, associate director of clinical laboratories at Massachusetts General Hospital and editor of Point of Care: The Journal of Near Patient Testing Technology.

"We have to form teams and get to know each other," he says. In the process, "we're beginning to get the hang of how to manage POC well." In fact, he says, the best labs now embrace POCT as an opportunity to improve patient care.

Other departments that do point-of-care testing have gained an appreciation for what the laboratory does, Dr. Howanitz says. "One of the most difficult aspects is to train the nursing staff or other operators to do all the things that will be required," he says. "It has made them realize just what is involved in doing a lab test."

CAP TODAY talked with a handful of hospital labs whose POC testing programs are considered to be a cut above the average. We wanted to know what they're doing and what works and what doesn't.

Capturing the data

At many hospitals, POC test results never make it to the lab information system. Nurses record them on the patient's paper chart—that's as far as they go. In some cases, the lab may get weekly reports, but there's no way to verify whether all the results are there.

At the hospitals CAPTODAY surveyed, by and large results are automatically uploaded into the LIS and from there into the hospital information system for use in an electronic medical record and for billing. But even the most highly automated hospitals don't yet capture all their test results electronically. The latest glucose monitors can be docked with a computer and their information can be transferred electronically, but other types of test results—such as activated clotting times or microscopy—are still recorded manually. Therefore, results typically remain within the unit where the test is performed.

"Without good data management, you can't have good control over the POC program," says Christopher Fetters, president of Nextivity, a POC consulting firm in York, Pa.

And bar-coded patient armbands, which nurses use to scan patient information when they're running the test, do a lot to shore up data handling, he notes. "Nurses are human and they're going to make mistakes," Fetters says. "How can you be sure the results will make it onto the right chart if you depend on a nurse to correctly enter a long patient number every time?"

Mercy Health System in Philadelphia is a three-hospital complex with about 800 beds and a core laboratory that coordinates POC testing, including 21,000 bedside glucose tests each month. The automated glucose and coagulation results are transmitted into the LIS, which generates the permanent electronic medical record. Urinalysis results are documented manually on a POC report form, as is glucose even though it's duplicative, says Bette Seamonds, PhD, clinical chemist and director of the point-of-care testing service. "The physician is not going to check two places for this information," the lab computer and the chart. "So the nurses are still putting them on paper because that's where the doctors are going to look," Dr. Seamonds says.

At the same time, the electronic results are uploaded into the LIS so they become part of the permanent record. Urinalysis results will be available once that connectivity is added to the system. "We simply don't have the manpower to put manual results into the computer retrospectively," Dr. Seamonds says.

Click here for more of the story, or check out the June 2002 issue
of Cap Today.

Advance for the Administrators of the Lab, Vol. 11 • Issue 6
The Dos & Don'ts of POCT
By Stephanie De Ritis

Point-of-care testing has become a familiar phrase. Now, it is important to make sure that the proper procedures are also familiar to those administering these tests.

The point-of-care testing (POCT) industry has been expanding steadily in health care. The current market value is about $4.9 billion, and this is expected to double in the next 10 years. The desire for this type of testing has been increasing because of all the benefits that can be derived from testing patients at the bedside.  Moving testing near the patient allows for immediate care and results. Also, with technology advancing the way that it has, more handheld devices are being created that are more accurate and reliable.  For all to go well, however, certain practices need to be followed while others need to be avoided. Reviewing what POCT departments should—and shouldn't—be doing will help identify problems within the processes.

One thing to do: Conduct a review of the procedures and tactics that should be followed within a POCT program. The purpose is to define that those actions contrary to the correct procedures would qualify as "don'ts."

To have a successful POCT program, some elements should be reviewed.

Training

Because the essence of POCT is its location outside of the central laboratory, there are many non-laboratorians conducting these tests, including nurses, physicians, emergency medical personnel and even the patients themselves. Monitoring each of these people would be impossible; therefore, training is essential to make certain that all of the tests are being performed correctly.

Choosing Devices

The buzz these days is which POCT device can provide everything that a facility is looking for. Selecting a device is important and, therefore, caution should be exercised to avoid making a hasty decision. Dolega believes that the first step is to consult the end user. Some may have used an instrument before and can provide valuable information as to how reliable it is. She believes, "There is no reason to spend time evaluating a product if an end user already has a strong negative opinion toward it."

Connectivity

Connectivity capabilities of the instrument are also important to consider when purchasing a POCT device.

"If possible, perform an information technology evaluation of the new POC device/data management system before signing any contracts or purchase orders," Dolega advises. "Determine the appropriateness of your current hardware, network configuration and/or phone system."

Compliance

Just like any lab, the POC department must be in compliance, along with all of the devices. Dolega recommends developing a plan to share compliance data with administrative managers, etc.

"Inspectors like to see that you have closed the loop–identified a problem, notified the responsible people, planned corrective action, implemented it and continued or pulled testing based on improvement or lack of improvement," Dolega comments.

She also feels it's important to develop a policy that states the consequences for a continued lack of compliance and/or improvement and set up a POCT advisory committee consisting of pathology personnel, clinicians and nursing leadership.

This complete article can be found in the June 2002 issue of Advance for the Administrators of the Lab.

Back to top

For years, laboratory testing was performed primarily in a central lab due to the complexity of the testing. However, "with computer chip technology, testing has emerged from the lab to the patient's bedside, the pharmacy, physician office, patient's home and other non-lab sites."¹

Patients are entitled to quality laboratory results regardless of who performs the tests and where or when the tests are performed. As a result, all sites performing lab testing are regulated under the Clinical Laboratory Improvement Act of 1988 (CLIA '88). Regardless of their location, all laboratories must be licensed to perform any testing. CLIA '88 identifies three levels of tests based on complexity. These categories include waived tests, tests of moderate complexity, which includes the subcategory of provider performed microscopy (PPM), and tests of high complexity.

CLIA '88 defines waived tests as "tests cleared by the FDA for home use." Waived tests use such "simple and accurate methodologies that the likelihood of erroneous results is negligible."² A site performing only waived tests must have a "certificate of waiver" license and must adhere to the manufacturers' instructions for performing the test. The most common waived point-of-care testing (POCT) procedures include glucose monitors, occult blood (fecal/gastric), urine dipstick, Group A Strep Antigen and spun hematocrits.^3,4

Considering POCT?

If you are thinking of increasing your revenue, this may not be a good reason. POCT, in many instances, is more expensive than a centralized laboratory test and revenues do not cover the costs. Costs may not be an issue for your practice or laboratory if performing the test at the point of care adds value and may benefit the entire delivery of health care services.

The value added by POCT includes improved compliance and follow up; better management of therapy; improved patient satisfaction and convenience; reduced repeat-care visits; smaller sample sizes; faster testing and reduced overall cost of care (Table 1). There are many published cases in which POCT has been demonstrated to reduce the overall cost of care.^5-7 For example, if a glucose level for a diabetic patient cannot be performed quickly in a physician office laboratory, it may lead to an emergency room admission and hospitalization at an estimated cost of $6,000 to $8,000. Early detection and intervention based on POCT results could have prevented the need for critical care and avoided this expense.

For more on this story, visit http://www.advanceformlp.com/MTcover.html 

Cap Today, April 2002
Bedside Bull's-Eye?

POC Cardiac Tests Gaining Acceptance
By Anne Paxton

Dramatic confirmation of the diagnostic value of POC cardiac markers has emerged within the past year. Yet how and where such testing is done is determined by the complex relationships between hospital laboratories and POC testing programs.

The need to rapidly triage chest pain patients is widely recognized, and device manufacturers—Dade Behring, Biosite Diagnostics, Spectral Diagnostics, and others—have produced multiple-marker test systems to address this need. 

"There are several instruments varying from qualitative to semi-quantitative to fully quantitative that are available now for near-patient marker testing," says Kristin Newby, MD, associate professor of medicine in the division of cardiology at Duke University School of Medicine, Durham, NC.  

The value of POC cardiac markers has been known since at least 1997.  And, during the past year, three significant trials that involved thousands of patients were reported in Circulation and the American Journal of Cardiology. Dr. Newby was director of one of the largest studies, the CHECKMATE trial. All three studies have confirmed that using combinations of troponin I, myoglobin, and creatine kinase at the point of care sharply increases the ability to identify patients with myocardial infarction.

This research adds credence to September 2000 guidelines from the American College of Cardiology and American Hospital Association, which recommended POC testing for cardiac markers. To be clinically useful, the guidelines say, the marker turnaround time should be within 30 minutes—a goal difficult to achieve without using bedside testing.

"These data are all just starting to come to fruition," says Scott Mader, director of professional education and development for Biosite Diagnostics, manufacturer of the Triage Cardiac Panel. "In fact, the maturity of the literature and these clinical guidelines studies, combined with the evolution of technology, has really been driving POC adoption of cardiac markers."

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Advance for Administrators of the Lab • April 2002 
Blood Glucose Testing in Acute, Chronic Care Facilities 

By James H. Nichols, PhD, DABCC, FACB 

While technology improves several aspects of diabetes management, there are still areas where caution must be exercised.

The advent of glucose meters has revolutionized the management of patients with diabetes by providing a means of rapidly determining blood glucose levels. Prior to the development of portable glucose meters, clinicians had to rely on dipstick technologies to estimate a patient's blood glucose.

The Diabetes Control and Complications Trial (DCCT) proved the potential of self-management with home glucose meters to control a type 1 patient's levels in the normal range, delaying the progress and eventual complications of diabetes. Normalization of glucose levels also improves the outcome and progression of microvascular complications in type 2 diabetics. Inpatient use of glucose meters has further become a standard of practice in managing therapeutic decisions for diabetics in acute and chronic health care facilities.

Yet, the potential benefit of glucose meters can only be realized if the device generates a quality result that can be relied on for patient management. Not long after widespread hospital use did the limitations of glucose meters become evident. Non-laboratory staff performing the testing often fail to acknowledge the need for quality assurance or realize the consequences of control failure on patient results. The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) further force the documentation of operator training and competency, the need for ongoing quality control and tracking of patient results.

Information Management

Manufacturers have responded to these meter quality issues through the addition of information management. Operator identification, control and patient results with a date/time stamp can be stored in the device memory, and the results can be downloaded to a computer system for tracking. Glucose meters adopted features that prevented patient testing when quality control failed and could track the operator (providing a means of linking an operator to training/competency records for regulatory compliance). However, clinicians faced with the need to perform a glucose test utilize whatever device manipulation will allow them to get a result. If the device is locked due to control failure, they discovered that they could still get a patient result by analyzing the patient sample in the control mode (identifying the patient as a control solution).

The rest of this story can be found in the April issue of Advance for Administrators of the Lab or by visiting the Advance for AL web site and subscribing to the journal for access to on-line articles.

Cap Today, February 2002
New Tools for Netting 
POC Connectivity
By Anne Paxton

If it were easy, anyone could do it.  Perhaps point-of-care testing coordinators who are trying to implement POC connectivity can take comfort in that thought. For despite the rampant enthusiasm about linking instruments with data-management systems, even the vendors concede that the course to connectivity runs anything but smoothly. Glitches, kinks, snafus, and snags go with the territory.

A much-anticipated step to ease the way was taken last November, when NCCLS approved an industry-wide, vendor-neutral standard, including standard messages, protocols, and technologies, that will permit POC instruments made by different manufacturers to talk to laboratory and hospital information systems. Under the standard, "new devices should seamlessly link into your existing data management system without additional expense" for wiring, computers, or software, if the vendor is CIC- or NCCLS POCT1-A-compliant, according to the Connectivity Industry Consortium, which formed, hammered out the standard, and dissolved itself all within 14 months.

Christopher Fetters, president and founder of point-of-care consulting firm Nextivity, in York, Pa., served as secretary to the CIC, and is pleased that the consortium was able to accomplish so much. "We never intended to have a 100 percent solution—but I never thought we'd get this close."

"I think it will move the whole industry," says Jay B. Jones, PhD, director of regional laboratories for Geisinger Medical Center, part of a large rural health maintenance organization in Danville, Pa. Some software vendors, in fact, are already advertising their products as "CIC-compliant."

Why was the connectivity consortium important? Until it was set up, the companies invested in POC data-management systems, and their customers, could only assume that their separate proprietary standards would continue to compete, and continue to be essentially incompatible.

Abbott Laboratories, Roche Diagnostics, and Johnson & Johnson all developed proprietary connectivity platforms that would communicate their own glucose instruments' data to an LIS, but in the last year Abbott and Roche began offering "open architecture" that would handle non-glucose POC tests as well as other vendors' devices. Two smaller vendors, Medical Automation Systems and Telcor Inc., do not sell devices or disposables for testing and advertise their platform as completely vendor-neutral.

In CAP TODAY interviews, customers of these five POC connectivity companies discussed the benefits they gained and pitfalls they encountered in implementing a data-management system for their POC instruments.

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Advance for MLP, Vol. 14 •Issue 4 • Page 13
Learning to Manage POC Data
By Daniella King 

Point-of-care technology has exploded in the clinical setting, but laboratorians must know the proper way to manage data collected by these miniature marvels. Even though hospitals and clinical laboratories are more technologically advanced than ever before, the convenience and speed of the high-tech instrumentation can be overshadowed when attempting to find connectivity and easy ways to manage all the data collected. As point-of-care (POC) technologies become more mainstream in clinical facilities, many laboratories may find themselves wondering how to manage the clinical information they provide.

"One of the most important drivers for data management has become the actual POC device," said Christine Ciaverelli, MBA, MT, H(ASCP), director of sales at Medical Automation Systems (MAS), Charlottesville, VA.  "Hospitals need a system that is going to enhance the functionality of POC devices. These data management solutions must be able to communicate bi-directionality between the device and the data management system. There are many systems that don't do this very well."

Data Management Hurdles

One major roadblock in finding the solution Ciaverelli describes is that few companies will interface more than one brand of device. Christopher Fetters, president and founder of Nextivity, a POC consulting firm based in York, PA, noted that this problem has caused hospitals difficulties on many different levels.  "Interfacing is a multi-staged problem. There are devices that are not interfaceable at all, for example. This is a burden for any hospital," he said. "They want to be able to do this testing, but capturing the data in the patient's chart for the lab for regulatory purposes becomes extremely difficult and is a huge waste of time and resources. The vendor has not produced a data management solution or a way of getting the data off the instrument."

Fortunately, steps have been taken to solve this interfacing dilemma.

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Point of Care & Critical Care

Blood Gas and Electrolyte Testing Continue to Grow

By Jan Hodnett, MS, MT(ASCP), Clinical Lab Products, January 2002

Labs love it or live with it, but point-of-care testing for critical care is among the fastest growing segments in the laboratory. Today, point-of-care blood gas and electrolyte testing is the standard of care. Two-thirds of all blood gas/electrolyte testing is performed outside the main lab — in satellite labs or by handheld analyzers, according to Irving, Texas-based CaseBauer, a research and consulting firm.

The more significant fact, according to the EAC survey, is that the total number of sites using point-of-care cardiac marker testing increased from 4 in 1999 to 25 in 2001, representing more than a six fold increase. Market share leaders in point-of-care cardiac testing, according to EAC, are Biosite Diagnostics, Dade Behring, Spectral Diagnostics and Roche Diagnostics.

For more of this story, click here.

*Source: 2001, EAC, Stamford, CT

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Measu ring Glucose from Alternative Sites on the Body  
How Does AST Compare to the Traditional Fingerstick Methods?  
By Sue Auxter, Clinical Laboratory News, Jan. 2002, Volume 28, No. 1  

Alternative site testing (AST) for glucose has become available to diabetics over the course of the last two years.  AST provides a less painful method of monitoring glucose levels than the traditional fingerstick method. However, recent studies indicate that there may be a significant difference between the two measurements during the time that the glucose is rapidly rising or falling.  The FDA’s Clinical Chemistry and Toxicology Devices Panel discussed this at an October meeting.  Manufacturers and scientists presented their findings.   This article provides discussion as to whether this phenomenon is device-specific or site-specific and what the manufacturer’s responsibility may be to make their users aware of it.  

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At the Bedside
Molecular Diagnostics at the Point of Care
Advance for Administrators of the Laboratory, November, 2001, Vol 10, No 11, Page 10 , 
By: Ronald C McGlennen, MD  

Genetics is becoming an important part of every lab discipline. Patients expect the availability of services like gene testing, a subject most practicing physicians know little about.  This consumer-driven mandate may bring genetic testing into the mainstream lab faster than many medical practitioners are willing to take on. 

For this reason, molecular diagnostics at the point of care may not move fast toward the bedside as it will to the local drugstore or retail outlet.  The challenge to distribute these tests first to the clinic and then to the consumer interface will require some fast action to accommodate what is likely to be a big demand.

POC Connectivity Concepts 
Data Communication Standardization 
Advance for Administrators of the Laboratory, November, 2001, Vol 10, No 11, Page 19,20 , 
By: Ellis Jacobs, PhD, DABCC, FACB  

Connectivity Industry Consortium (CIC) initially determined five technical areas to examine: device interface, electronic data interchange (EDI) interface, quality assurance (QA/QC) reporting interface, security and information model. Three specification documents were developed and approved by the CIC membership in May 2001 and handed over to NCCLS for publication.  Since this time, a subcommittee has been formed, the document has been revised and voting for the final publication is to end in December.  This document will provide the framework for engineers to design devices, workstations and interfaces that allow multiple types and brands of POCT devices to communicate directionally with access points, data managers and LISs from a variety of vendors.  It is our responsibility as customers/ users to require that all POC testing vendors make their products compliant with these standards.

Serum Markers of Risk for Coronary Artery Disease
Advance for Administrators of the Laboratory, November, 2001, Vol 10, No 11, Page 41-44 , By: David Plaut

Coronary artery disease (CAD) is the leading cause of death in the United States. A number of markers have been proposed as indicators of risk for CAD:

• Cholesterol- 35% of MI patients have total cholesterol levels below 200mg/dL

• HDL: antiatherogenic effects as a result of its reverse cholesterol transport (HDL move cholesterol to the liver)

• LDL: composed of two types of particles; more common is the larger, less dense (phenotype A) and the small dense (B) which is more commonly associated with increased levels of triglycerides, fibrinogen and reduced levels of HDL.

• Apolipoprotein A and Apo B: assays are not common as standards have not been agreed upon and there is more than one Apo A and several Apo Bs.

Triglycerides:

• Lipoprotein(a): is a highly heterogeneous lipoprotein that may be influenced by environmental factors and events relating to oxidative processes, and the action of some enzymes.

• Homocysteine(HC): relation between serum levels of HC and CAD may be related to the cytoxic effects of HC on endothelial cells. A 5mg/dL rise in HC raises the risk of CAD by about 20%.

• CRP: CRP and inflammation may be more involved with plaque stability and rupture than in plaque formation.

• Fibrinogen: an increase of about 1SD of plasma fibrinogen (75mg/dL) was found to increase risk of CHD and all-cause mortality 29% and 31% respectively.

• Troponin I and T: proposed as gold standards for cardiac damage.

Betting on Chips
Advance for Administrators of the Laboratory, November, 2001, Vol 10, No 11, Page 53-56 , By Victor Walter Weedn, MD,JD

Where there’s a Bill, There’s a Way to Make Clients Pay 
CAP Today, September, 2001, pg 1,58-64 By: Mark Uehling

“Health Care people have a mental attitude that their responsibility is patient care, and that the functional aspect is just a necessary evil,” says Degrote.  As a result, some experts say more than half of all debt in the United States is related to health care.  A staggering $20million is written off by the medical industry annually. Laboratories must assure the accuracy of client billing information on the front end of data entry.

It’s not just that people are avoiding their bills, one hospital claims that 20% of its address problems are just bad typing.  Take a different approach: train the billing staff to know when requisitions are complete, not just from a medical standpoint but from a financial one.  

“When you’re looking at the requisition, the one piece of information that should be on your mind should be: Am I going to get paid or not?”

CPT Code Deliberations Come out of the Dark

CAP Today, September, 2001, pg 5

By: Coulson Duerksen

For the first time, laboratory groups had a say in how new tests will be coded and reimbursed in the next year’s clinical laboratory fee schedule.  Stakeholders agreed in large part on whether codes should be cross-walked or gap-filled. The only real difference of opinion  centered on which code to cross-walk to.

Moderating Menu to Lighten Load
CAP Today, September, 2001, pg 34 , 
By: Raymond D. Aller, MD

Dr Aller urges vendors to move toward critical chemistry instruments that could be teamed with one or perhaps two other devices to encompass the range of analytes. Pages 36-58 profile 23 in-vitro blood gas analyzers from 8 vendors.  Before purchasing an analyzer, talk to end-users about vendor’s performance claims, instrument reliability, and quality of customer support.

Point-of-Care Lactate Testing in the Intensive Care Unit

CAP Today, September, 2001, pg 70 , By: Michael Bissell, MD,PhD

There are two types of lactic acidosis: type A lactic acidosis, resulting from poor tissue perfusion and type B, in which there is no clinical evidence of poor perfusion. While blood lactate has been reported to be a good correlate to clinical outcomes, the reliability of a single value as a marker of successful resuscitation or as a predictor of patient outcomes has been questioned.  

Two different point-of-care analyzers: Accusport hand-held and the bench-top blood gas analyzer were used in a 40-patient study and compared to the laboratory reference method.  The authors concluded that blood lactate could be rapidly, easily, accurately measured at the bedside using both tested methods.

At the Bedside 
Professional Connections
advance For Administrators of the Laboratory, October, 2001,Vol 10,No. 10, Pg10 , By Robyn Medeiros

In March of 1997, the Bay Area Point-of-Care Coordinators’ (POCCs) group was formed. The primary focus of the group is to discuss what does and doesn’t work from their respective POCT programs.  Each meeting has a main topic and they invite technical representatives from different companies to display their product line. By coming together this group has established a huge resource group of 70 members representing 35 hospitals over a 150- mile radius.  Medical Automation Systems (MAS) sponsored the Bay Area POCC and provides a sub link to web site: www.PointofCare.net.  MAS has since sponsored 6 additional POCC groups around the country.

Clinical Laboratory Science, Vol 14, NO 3, Summer 2001, p. 155-159

Sweat Chloride: Quantitative Patch for Collection and Measurement

Warren J. Warwick, Leland G. Hansen, Ione V. Brown, Wendy C. Lane,

Kathleen L. Hansen

The objective of this study is to compare the Gibson/Cooke Sweat test and the CF quantum test.  The measurement of sweat chloride is the standard for the diagnosis of cystic fibrosis.  However the quantitative pilocarpine iontophoresis technique has many problems the most common of which is the inablility to collect enough sample, especially from infants.  The CF quantum test uses a much smaller sample size and compared well with the classic Gibson/Cooke test.

Clinical Laboratory News, Oct. 2001

Industry Profiles: page 30

Abaxis Supplies Medical Service:  Princess Cruises has chosen Abaxis’ Piccolo blood analysis systems to replace it’s slide based analyzer technology.  Princess hopes the switch will save on labor by providing medical staff with test results in 15 minutes.

Washington Profiles: page 26

JCAHO Announces Laboratory Proficiency Testing Requirements for 2002:

JCAHO recently announced that effective January 2002, JCAHO accredited laboratories must submit verification to JCAHO that they are enrolled in proficiency testing.

Clinical Chemistry, October 2001 , 2001;47:1845-18 47 

Total Bilirubin Measurement by Photometry on a Blood Gas Analyzer: Potential for Use in Neonatal Testing at the Point of Care

Boris Rolinski^1a, Helmut Küster², Bernhard Ugele¹, Rudolf Gruber¹ and Klaus Horn¹

For monitoring hyperbilirubinemia in the newborn, methods are desirable that provide fast but reliable results from very small volumes of whole blood, enabling bilirubin measurements at the point of care. The authors of this article evaluated a new method that uses a blood gas analyzer with multiple-wavelength photometry to determine total bilirubin concentrations in whole blood from jaundiced and nonjaundiced neonates and compared the results with a standard clinical chemistry procedure for total bilirubin measurement in plasma.