One of the hardest aspects of point-of-care testing (POCT) is trying to make the diverse users of POCT devices follow written procedures and perform testing exactly as stated by manufacturers. The simplicity of POCT devices, often involving disposable kits with no maintenance or troubleshooting, tempts users to take shortcuts. The downside of this approach is that when procedures are not followed to the letter, mistakes happen. POCT devices are designed so they can be used by anyone with at least a high school diploma, hence users range from students to physicians.
Here at Temple University Hospital (TUH) and TUH Episcopal Campus, we have worked over time to successfully implement a system for ensuring and documenting compliance with labeling requirements for these POCT devices, starting with glucose meter strips and controls.
Self-monitoring of glucose using glucose meters has been shown to reduce mortality and morbidity associated with the complications of diabetes and therefore is strongly advocated by the American Diabetes Association. Tight glycemic control of hospitalized patients also has been shown to speed patients’ recovery and reduce their length of stay. Consequently, TUH, like many other organizations, follows tight glycemic protocols.
The science of glucose meters resides in their strips. These vital components house the reagents and host the reactions that spur redox reactions and generate current, which glucose meters measure and display as a quantitative value. This means that discarding a strip is like throwing away an entire laboratory instrument. Clearly, strip integrity, though easily overlooked, is an essential aspect of POCT-based glucose measurement.
Because of strips’ vital importance, regulatory bodies assess for compliance with manufacturers’ stringent strip storage recommendations. In particular, once glucose meter strips and controls have been opened, their expiration dates need to be documented, since the strips start deteriorating and can give unreliable results if used past their new expiration dates.
The Nova Biomedical glucose meter strips we use here at TUH have 180-day expiration dates, and their controls expire after 90 days. Imagine the challenge of ensuring that some 2,000 nurses comply with the strip container labeling requirement. It takes just 2-3 days to run through a container of strips, or even less on a busy nursing unit. Documenting when a container has been opened understandably is not in the forefront of a nurse’s mind, concerned as he or she is with patient care duties and knowing that the container will be finished in a few days anyway. It is an easy task to forgo. However, if we were to have an inspection in the time an unlabeled strip container was in use, we would be at risk for a citation, jeopardizing POCT at the facility. Furthermore, sloppiness in this seemingly incidental aspect of care could give the inspectors the impression of similar carelessness in other areas. Hence it is an important window into quality assurance for the entire hospital.
When I arrived at TUH 10 years ago, our compliance with glucose strip labeling was poor. POC coordinators (POCC) would verbally remind nurse managers or nurses that they needed to improve in this regard, but this was more of a ritual and follow-up was not actively pursued. We employed several approaches to improve compliance. First, we measured non-compliance data so that we could track our progress. We grouped the data by floors according to nurse director and emailed our analysis to them so that each nurse director could see how his or her floor was doing in comparison to peers (See Figure 1). Delivering this information to the nurse directors was vital, since nurse managers report to the directors—not POCCs or anyone in laboratory administration.
To ensure noncompliance was being followed up on, I met regularly with nurse directors. In addition, we circulated to the nurse directors an inspection checklist that included questions that came up in prior inspections (See Box, left). This approach, anchored in our regular interactions and feedback with the nursing leadership, changed compliance over a 10-year period from an average of 37% to 98%. We since have successfully employed this model for other POCT, and in all cases close teamwork with the nursing leadership made the difference. Their success is our success and vice versa.
Adil I. Khan, MSc, PhD, is director of point-of-care testing at Temple University Hospital (TUH) and TUH Episcopal Campus, director of clinical chemistry at TUH, TUH Episcopal Campus, and TUH Northeastern Campus, and assistant professor of pathology at the Temple University Lewis Katz School of Medicine in Philadelphia.+Email: [email protected].
Inspection Preparation Checklist
Inspectors will ask nurses about point-of-care tests performed on each floor. Nurses will need to:
- Perform each test according to procedure.
- Know the name of the instrument they use for testing.
- Have read and know:
- Storage conditions
- Specimen requirements
- Temperature (operation and storage)
- How to interpret results
- How long strips and controls are valid after opening
- Timing requirements for results
Questions From Our Last Inspection
- What should happen following a critical high (or critical low) glucose result?
- How do nurses know when a glucose meter quality control has been performed?
- Walk the inspector through the steps in performing a whole blood glucose test with a glucose meter.
- How does a nurse identify a patient?
- How are glucose results charted and critical results followed up on?
- Do patient charts have reference ranges?
- Is a manual available or a knowledgeable person accessible to help troubleshoot the instrument/procedure?
- What do you use to clean glucose meters?