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Evolving World of POCT

As assays, applications evolve, competency assessment is even more crucial

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Vol. 21 • Issue 3 • Page 14

Cover Story

Although point-of-care testing (POCT) has its critics when its accuracy is compared to "traditional" laboratory testing, its value in offering expedient results in both conventional and unconventional settings often outweighs the argument. What's more, new applications for POCT continue to be explored, which makes this an area to stay abreast of from technology, personnel and regulatory standpoints.

Infectious Diseases

Infectious disease control, for example, requires accurate and rapid diagnosis so affected persons can be treated to limit the spread of infections. The detection of HIV infection, particularly in underserved populations, has been revolutionized by rapid, waived, point-of-care (POC) HIV tests. These tests allow outreach programs and emergency rooms to provisionally diagnose HIV infection and deliver results of the screening tests before the patient leaves the facility. New rapid hepatitis C virus tests may do the same for this widespread disease.

Traditionally, POCT for infectious diseases has included rapid detection of group A streptococcal infections, which allows immediate prescription and treatment so patients can return to school and work sooner and limit the transmission of strep throat. As well, rapid diagnosis of infectious mononucleosis and influenza allows providers and patients to recognize these conditions, limiting the need for expensive and time-consuming diagnostic workups. Rapid detection of Lyme antibodies also allows immediate treatment.

Current POC methods for direct detection of infections such as influenza and group A Streptococcus are, however, inferior to laboratory-based methods such as culture and molecular amplification. Emerging technologies in molecular diagnostics are beginning to generate POC infectious disease tests that perform as well as laboratory-based methods and that will have a significant impact on individual patients and public health.

Competency Assessment

To ensure your hospital's POC program is operating optimally and able to implement additional POC assays as they become available, staff must be competent and assessed accordingly. The words "competency assessment" can send shivers down the spine of even the most seasoned point-of-care coordinator (POCC); with so many regulations with which to comply, operators to observe and skills to assess, where should a POCC begin?

Competency assessment is actually several steps into the quality management system process and must be preceded by well-written, functional policies and procedures that define the laboratory's POCT program. Essential contents of these documents include:

• the names of the tests that will be performed;

• the manner in which specimens will be collected, labeled and processed;

• detailed step-by-step directions for test performance;

• explanation of control procedures and corrective action steps;

• limitations and reference intervals; and

• instructions for entering results in the patient record.

An excellent reference for use in the development of procedures is CLSI document GP02, Laboratory Documents: Development and Control.1

This document provides guidance on development, review, approval, management and use of policy, process and procedure documents. Once the policies and procedures are drafted and finalized, the POCC should implement any necessary training to ensure staff members have the knowledge to perform the indicated tests.

Adequate training is essential and must be completed before the operator can be held accountable for proper test performance. Important questions to consider when planning such training include:

• Who will be the trainer(s)?

• How will the information be presented?

• What steps are error prone and will need focused attention?

Also, the POCC should decide how to document comprehension of the training. This step can be accomplished through the use of questions on a post-training test, the testing of blind samples or direct observation of skill performance by the trainer.

CLSI document GP21, Training and Competence Assessment,2 presents a four-stage process for establishing a training program, the components of which are:

1. training needs identified,

2. training guides developed,

3. training implemented and

4. training outcomes evaluated.

Assessment Methods

To be competent is to be capable, proficient and skilled. The Joint Commission lists several options for competency assessment methods, which include performance of a test on a blind specimen, periodic observation of routine work, monitoring quality control (QC) performance and the use of a written test. 3 The College of American Pathologists (CAP) phrases its elements of competency assessment as:4

• direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;

• monitoring the recording and reporting of test results;

• review of intermediate test results or worksheets, QC records, proficiency testing results and preventive maintenance records;

• direct observation of performance of instrument maintenance and function checks;

• assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and

• evaluation of problem-solving skills.

POCCs may also consider, when possible, using the POCT tasks already in place to meet assessment needs. QC records and reports that provide the details of an operator's performance and instrument statistics are reviewed daily, weekly or monthly. Subsequently, the POCC may use the information within these records to meet competency assessment requirements, rather than impose additional activity on the POCT operators. Also, the POCC should make every effort to incorporate more than one regulatory standard into each assessment step. Consider the following options.

Direct Observation

The CAP POCT checklist requires that personnel be knowledgeable about the contents of the procedure manual. Use the step-by-step test directions from the POCT manual as the basis for designing a direct observation checklist and as a means of documenting that knowledge. List the steps in order, including pre-examination (patient preparation and specimen collection), examination (test performance) and post-examination (result reporting).

Arrange the components of each step in the form of a question. For example, if specimen collection requires a capillary fingerstick, rather than use a subjective question such as, "Was the fingerstick performed correctly?" phrase the question in the following format:

Did the operator:

a) select an appropriate site?

b) clean the site with alcohol and allow to dry?

c) wipe away the first drop of blood?

In this way, important elements of specimen collection are listed separately, allowing the observer to evaluate each criterion independently and specifically identify deviations from proper procedure. An operator who follows all steps as defined in the procedure demonstrates an understanding of the procedure manual content during his competency assessment direct observation.

The POCT setting is more susceptible to variables in the pre-examination phase of testing than the typical laboratory setting. CLSI document POCT07, Quality Management: Approaches to Reducing Errors at the Point of Care,5 includes tables addressing the most common pre-examination variables considered potential sources of errors. Potential errors include:

• nutritional status and diet of the patient,

• pharmaceuticals or food supplements taken by the patient,

• contamination or dilution of the specimen,

• hemolyzed, lipemic or icteric specimens;

• missing or incorrect patient or test personnel identification.

Performing the direct observation of a routine patient test in the setting typical for that operator (as opposed to at a skills fair) may provide a more representative indicator of the operator's usual test techniques and a better opportunity to identify the presence of these preexamination errors.

Monitoring Recording, Reporting of Test Results

Interfaced instruments have allowed for efficient and accessible monitoring of result reporting. Most data management software allows for the creation of reports and/or the use of filters to selectively review critical values and values outside the analytical measurement range (AMR). When manual POCT is ordered and resulted through the use of an electronic medical record (EMR), the POCC can monitor compliance with result reporting procedures by quickly generating a list of all patients in the hospital information system or laboratory information system for which particular tests have been ordered. By using the EMR to review those patients' records, the POCC will gain a clear picture of the operators who are incorrectly reporting results. Frequent reporting errors may also identify a process problem and lead to opportunities for improvement by changing the format of the electronic reporting system or limiting the available reporting options. For example, restricting allowed results to only those values within the AMR will prevent the error of charting values outside the AMR. This approach can invoke immediate compliance when even the best education attempts have failed.

QC, Preventive Maintenance Records

While lock-out features available on many POCT instruments make in-range QC required before patient testing, QC review should be a part of the POCT quality management plan. It is easily accomplished through the use of interfaced instruments and meets two requirements at once. Review of these records not only reveals instrument and reagent issues, but also identifies operators who repeatedly require corrective action steps, pointing out errors with sample application, instrument setup or testing techniques. Following the corrective action steps, as defined in the procedure, will demonstrate an operator's knowledge of the procedure manual content.

Operators who experience difficulty with control testing should be supervised closely to detect whether the same issues are also occurring with patient tests. Determine an acceptable control success rate (e.g., 90 percent within range) and use operator statistics reports, which are available within most data management software, to monitor an operator's performance.

Review of Proficiency Testing

In the POCT checklist, CAP states, "Proficiency testing records . can be an important part of the competency and continuing education in the personnel files of those individuals performing testing." The checklist also advises that "proficiency testing samples should be periodically rotated . among all personnel who routinely test patient specimens." For glucose testing, most proficiency test providers allow the submission of 20 results so the opportunity exists to satisfy proficiency simultaneously. Some providers of proficiency samples also allow the purchase of extra sample sets for internal use and, because these additional results are not reported or graded, the cost is reduced.

Previously Analyzed Specimens and Blind Testing Samples

While use of proficiency samples can prove efficient for small groups, it may also leave hundreds of operators without the opportunity to participate. Again, the POCC should consider using events already occurring to compensate for this disproportion.

For example, the laboratory's competency assessment program can be designed to include a report that matches all laboratory and POC tests for the same analyte performed on the same patient within 10 minutes of one another. Not only can such a report compare the operator's POCT result to its comparable laboratory value and meet the previously analyzed or blind sample criteria, but it can also be used to monitor the operator's problem-solving skills when a discrepancy in values is noted. In addition, it can serve as a means to document the correlation of the POCT instrument to the laboratory method.

Use competency assessment as a learning opportunity and remind trainers and observers to approach the assessment steps not as a means for disciplinary action, but as an educational process. Following such a process can provide an opportunity to refine the information the operator retained during initial training, correct any misunderstandings and pinpoint areas that need improvement in the training program or testing procedure. Laboratorians share the comprehensive goal of better patient care; a well-planned competency assessment program proves that POCCs and POCT operators are intent on achieving it.

Maureen R. Bush is point-of-care coordinator, Bay Medical Center, Panama City, FL. Dr. Campbell is associate professor of Laboratory Medicine, Yale School of Medicine.

References

1. CLSI. Laboratory Documents: Development and Control; Approved Guideline-Fifth Edition. CLSI document GP02-A5.Wayne, PA: Clinical Laboratory Standards; 2006.

2. CLSI. Training and Competence Assessment; Approved Guideline-Third Edition. CLSI document GP21-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.

3. The Joint Commission. Periodic Performance Review. Oakbrook Terrace, IL. 2010, http://www.jointcommission.org/assets/1/18/Periodic_Performance_Review_2010.pdf.

4. CAP. Point-of-Care Testing Checklist. Northfield, IL: College of American Pathologists; 2010.

5. CLSI. Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline. CLSI document POCT07-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2010.

Sidebar: A Need for Speed

POCTs are impacting infectious disease control.

Point-of-care testing (POCT) is rooted in an urgent need for speed, particularly where infectious diseases and public health intersect. Sheldon Campbell, MD, PhD, FCAP, Department of Laboratory Medicine, Yale University School of Medicine, says a POCT "explosion" has had a radical effect in rapid identification and treatment of people with HIV.

"It used to be when people went to a confidential HIV testing facility, they would give a blood sample then call back in a couple of days to get results," explains Campbell. That might have been OK where follow-up is a failsafe, but not in the world of HIV-up to a third of people infected in the U.S. do not know it.

"Only 70 percent who go to confidential testing sites return for the results," says Campbell. "Think about it: People have to work up courage to get the test, then they have to work up courage to get the results. It may be something they don't want to face. They could be in denial, fear." And they might never go back.

Rapid Test Means Rapid Treatment, Prevention

With rapid HIV POCT, negative or provisional positive results are immediate. Those tested are referred for treatment, or counseled about prevention. "The most critical components of the encounter happen immediately, all at once," says Campbell.

Other healthcare scenarios also have been impacted by rapid HIV POCTs. "They are being used in EDs," explains Campbell. "Not everybody who needs to be tested for HIV makes the effort. Now we often do 'opt-out testing'; people who encounter the healthcare system are tested unless they specifically tell us not to."

He says the imperative in public health is to test anyone 13 years of age and older for HIV. "Now it's a manageable disease," says Campbell. "Everybody should be tested so we don't miss anyone whose life can be extended with therapy; and treatment will also decrease transmission."

POCTs have been "somewhat revolutionary" in preventing transmission of HIV to newborns, as well. The rate of transmission from an infected mother to her infant is 30 percent without prophylactic anti-retroviral therapy prior to delivery. "But that number drops to one percent if a woman receives therapy, even at labor onset," says Campbell. "When an untested woman starts labor, you can't wait two days to get an HIV result. You end up treating a lot of people unnecessarily, and you don't want to do that with newborns. Providing that result immediately is an essential part of labor and delivery care."

Certainly laboratorians have personal reason to applaud the availability of HIV POCT in needlesticks and other exposures. "Instead of putting everyone on prophylaxis for days, we can test the source patient immediately and give prophylaxis in a more thoughtful and risk-based manner," says Campbell.

POCTs in Development

Yet the strengthening of POCTs is not all about HIV; there is a new rapid test for Hepatitis C that Campbell calls "highly significant."

Traditionally, rapid influenza testing has been markedly inferior to laboratory-based testing. "It's a challenge to get good specimens," explains Campbell. "We get specimens with hundreds-instead of thousands-of flu viral particles. To detect with a rapid antigen test we need thousands of particles. So the rapid flu test, compared to viral culture or the gold standard-molecular amplification-is only 50-70 percent effective, sometimes less."

Campbell says within the next few years ".instead of doing inferior antigen tests for flu, strep or respiratory syncytial virus at point-of-care, we'll do really good POCTs for infections using molecular diagnostics."

The tests will employ polymerase chain reaction (PCR) or some other molecular method. "There are a lot in development. A couple of instruments are simple enough to allow for rapid flu testing in a small hospital lab, a hospital ED or a physician's office laboratory and to get back a sensitive, specific result in a clinically useful time frame."

In fact, in late December, Quidel Corp. received FDA clearance for the sale of its molecular Influenze A+B assay, which, according to Quidel, provides for simple transport, storage and a short time to result.

When tools are in place for POC molecular diagnostics, ". it also will be a real game-changer in sexually-transmitted disease testing," says Campbell. "Right now tests for gonorrhea and chlamydia take two days. Those infected are often from transient populations, and may have social issues that make it hard for them to return for results. If we could test for those things in a single visit we could improve control of those diseases."

Likewise, there's an urgent need for speed in less-developed, TB-endemic parts of the world, where patients travel hours or days to reach a clinic, and may not be reachable after they return home. "There's a relatively new system, the GeneXpert, which detects TB and rifampin-resistance in TB using PCR; it's still quite expensive," says Campbell. "It's simple to use, but it's still complex as far as durability and maintenance go, so there are barriers to widespread use."

Noting there is a tremendous need for POC diagnostics for diseases like malaria, dengue, and other diseases of less-developed areas, Campbell hopes continuing developments will forge a fast track to worldwide impact.

Valerie Neff Newitt is managing editor.




     

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