How should a lab design a fail-safe system for point-of-care testing?

Q: We recently had a serious problem with point-of-care testing. A temporary agency nurse was in charge of testing blood sugars on a hospitalized patient. She tested and found a blood sugar in the severely hypoglycemic range, but she did not record the information in the proper place in the chart. Instead of writing it in the diabetic flow sheet, she recorded it in the notes. As a result, the nurse in charge of giving the patient his insulin shortly thereafter did not hold the dose. This happened three times over the course of the weekend. The patient had advanced cancer, and his fading consciousness was attributed to progression of his disease by the attending physician, who also did not see the bedside glucose values. Fortunately, the morning shift nurse who took over the following Monday caught the problem, held the insulin, and the patient recovered. Obviously, we did a complete investigation of the incident, but it is still troublesome that such an event could occur in our institution, and I am concerned that other such disasters are waiting to happen with our increasingly decentralized, point-of-care testing. What is the responsibility of the lab in designing and implementing fail-safe systems for decentralized testing.

A: Aside from some questions about the responsibility of the nurse and the physician to investigate blood sugar results in a diabetic patient, your situation which is obviously extreme points out several of the pitfalls of point-of-care testing. At the very least, it illustrates just how vigilant a laboratory staff must be to ensure that decentralized testing is as accurate, as well controlled, and as efficiently reported as testing that is run in the main lab.
As is the case with your hospital, decentralized testing often relies on nursing staff to perform tasks that have historically belonged to the lab. Because nurses are not always well trained in laboratory methods and the culture of laboratory medicine, particular care must be taken to ensure that they learn the rules of reporting and recording information in the same way that the laboratory does. This means ensuring that some system is in place to guarantee that a specimen is properly tested, the test result is accurate, and that the information gets back to the medical record and the responsible physician in a clinically reasonable time and manner.

A good point-of-care program will involve both nursing staff and lab staff in designing procedures. Laboratory input is imperative to ensure that proper quality control and proficiency testing programs are implemented, and to ensure that the recording and reporting of results are in line with laboratory standards. In this case, the nurse who did the testing failed to meet laboratory standards for management of information in two ways: She did not record the data in the proper place, and she failed to notify the physician or other responsible caregiver of a critical value, as would be expected in a laboratory setting. You should review your policies to ensure that they are clear about where to record information and the need to follow notification procedures for panic values.

Some institutions also require that bedside glucose levels in the extremely high or extremely low range be confirmed by testing in the main laboratory. This provides a check on the accuracy of handheld instruments, which can be less reliable at extremes of measurements. It also involves the central lab in the process, and can help ensure that proper notification is made if critical values are confirmed.

Your situation also illustrates the problem with part-time and temporary personnel. Orientation procedures sometimes fail to cover all the differences in procedures and policies from institution to institution, and an overworked supervisor may not think to check to make sure that follow through has been done correctly. As a result, its a good idea to include in your point-of-care policy the caveat that temporary or supply staff should not perform point-of-care testing until and unless they have been thoroughly acquainted with the process, including how to record values and when notification must be made, in addition to recording values in the chart.

When our hospital instituted bedside glucose testing many years ago, we encountered another unexpected difficulty. Nurses charged with performing bedside tests were performing the required controls, but did nothing when a control value was out-of-range. Not being trained in the QC mindset of the laboratory, the fact that the control was not accurate did not indicate to them that there was a systematic problem with the instrument, and they proceeded with testing anyway. It took a detailed in-service from laboratory staff to educate the nursing staff about the need for controls and the necessity for seeking help when control values were out of range. Your policies should provide for regular review of nursing compliance with such laboratory requirements as running controls, calibration and validation of instruments (particularly when introducing a new instrument into service), and management of problems encountered.

Although most instruments are designed for ease of use, no staff member should be performing bedside testing without proper training, and competency checks should be incorporated in the regular review process for all employees performing decentralized tests. In our institution, after proficiency testing has been done for CLIA purposes, we use the remaining test sample to check the proficiency of the nurses who perform bedside glucose testing. This provides an avenue for regular proficiency testing as well as permitting us to compare competencies among peers given the same sample. The laboratory should oversee such competency testing to ensure that training and proficiency standards are clearly stated and consistently met.

Keeping untrained personnel from performing bedside testing can be problematic, though technological advances have helped enforcement. Some instruments require the operator to enter a unique personal code in order to be able to use the instrument for testing. The laboratory should issue codes only upon completion of training and demonstration of competency, and should delete codes from the active list if the operator fails later competency reviews. Additionally, any staff sharing codes with another, untrained operator should be subject to discipline. 

If bedside instruments do not have automatic lockout features, then a log of tests performed and the operators performing them should be reviewed by the lab regularly to ensure that only trained personnel are involved in bedside testing. Nursing staff cooperation is essential to ensure that operator requirements are enforced. Training and in-services on a regular basis will help to provide sufficient nursing staff to handle point-of-care testing.

Properly run, decentralized testing can be a great boon to patient care and can function as an effective, efficient, and accurate extension of the laboratory. As you have seen, poorly planned and executed bedside testing can compromise patient care precisely because of the lack of safeguards that otherwise make laboratory medicine so effective in disease management.

Barbara Harty-Golder is a pathologist-attorney in Sarasota, FL. She directs the clinical laboratory at Health South Rehabilitation Hospital in Sarasota, as well as maintaining a law practice with a special interest in medical law. She writes and lectures extensively on healthcare law, risk management, and human resources management.

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