Long-Term Care Survey Alert

Published on Mon Sep 27, 2010 PDF

One option provides a way out of this tricky infection control issue.

Test yourself: Does failing to clean a blood glucose meter in between nursing home residents rise to the level of immediate jeopardy?

Based on an IJ example in the revised F441 infection control guidance that CMS released last year, the answer was yes. And, as a result, a number of facilities nationwide receive IJ citations, says attorney Paula Sanders, with Post & Schell in Harrisburg, Pa. But CMS has done an about-face of sorts on the IJ issue.

Important change: In an Aug. 27 survey & cert memo, CMS says that not cleaning and disinfecting blood glucose meters when used on more than one resident does represent a deficiency that should be corrected. But the practice "may not constitute immediate jeopardy," the memo states. Surveyors would determine the scope and severity based on further investigation by using the F441 interpretive guidelines and investigative protocol. CMS is revising the IJ example for F441 in Appendix PP in the State Operations Manual accordingly (see page 76 of this issue for the new example).

The memo clarifies a survey issue that has caused considerable concern in the industry due to lack of scientific evidence supporting IJ. For example, when Sanders represented one nursing facility that got an IJ citation for failing to clean a glucometer in between patients, she found that the "Centers for Disease Control & Prevention literature didn't appear to clearly indicate that failing to clean glucometers in between patients posed immediate jeopardy."

"CDC had published a report about transfer of hepatitis B among persons receiving blood glucose monitoring in nursing homes," says Deb Burdsall, RN, MSN, C, CIC, a spokesperson for the Association for Professionals in Infection Control and Epidemiology, and a corporate infection preventionist for Lutheran Life Communities in Arlington Heights, Ill. But in that report, nursing home providers were using a lancet pen to obtain fingerstick blood glucose samples on multiple residents, she says. And that is definitely a practicethat can spread blood-borne pathogens from patient  o patient.

Beware: "Fingerstick devices must never be used for more than one resident," CMS stresses in the survey & cert memo. That's true even if the package instructions for some devices indicate or imply that you can potentially use them for multiple patients, CMS says.

As for the potential to spread blood-borne pathogens by failing to clean a glucometer: Burdsall says "it's remotely possible" that could happen, if a person had an open area of skin that came in contact with dried blood on the device. The revised survey guidance for F441, however, combined reuse of a lancet pen and and/or failure to clean a glucometer as both posing immediate jeopardy to nursing home patients, she says. (CMS' revised IJ example at F441 still includes reuse of a fingerstick device -- see page 76 of this issue.)

The FDA weighs in: An FDA MedWatch memo that appeared to pave the way for the Aug. 27 CMS survey & cert memo has the following to say about POC blood testing devices: Whenever possible, POC blood testing devices, such as blood glucose meters and PT/INR anticoagulation meters, should be used only on one patient and not shared. If dedicating POC blood testing devices to a single patient is not possible, the devices should be properly cleaned and disinfected after every use as described in the device labeling.

CMS' survey & cert memo directs nursing home providers to clean and disinfect blood glucose meters according to the manufacturer's instructions. In a footnote, the memo defines manufacturers' instructions as those derived from "package inserts, published literature, communications between the manufacturer and the nursing home or other parties, or any other form of communication from the manufacturer that identifies cleaning agents, methods, and assurance of compatibility between agents used and the product itself."

When point-of-care devices don't have manufacturers' instructions for cleaning in between uses, CMS strongly advises nursing homes not share the devices among residents, the memo states.

Watch out: If you are using a glucometer for more than one resident -- and the device doesn't have manufacturer's instructions for cleaning -- expect surveyors to ask how you are cleaning it. In such cases, surveyors will cite the facility if the facility can't "clearly establish" that it's using safe, commonly accepted infection control measures, states the memo. That would be "authoritative references to published research, CDC recommendations, recommendations of professional societies, or similar references to commonly accepted professional practices."

Resource: A February 2010 document prepared by the American Society of Consultant Pharmacists provides helpful information on cleaning and disinfecting glucometers. It also includes a chart listing manufacturers' recommended cleaning instructions and contact information: www.ascp.com/advocacy/briefing/upload/Glucometer%20Infection%20Control-rev.pdf. (The information hasn't been updated since February, so providers should confirm the instructions with the manufacturer, an ASCP spokesperson says.)

Time-management tip: When using a cleaning and disinfectant agent, make sure to review the instructions for contact time, advises Burdsall. In her own analysis of instructions from manufacturers of cleaning/disinfecting agents, Burdsall found that the recommended contact times range from one to 10 minutes. "Shorter contact times are better," she says. "You have to be realistic. Ten minutes in between uses is going to be difficult to accomplish on busy nursing units."

Using dedicated glucometers is one way to sidestep the infection control issue and potential F tags. Some of Sanders clients have taken that tack, although it poses a storage issue, she notes. Burdsall believes, however, that weighing the cost-benefits of that option is worthwhile to do. "Sometimes you'd be surprised that the meters are not as costly as you would think."

Editor's note: You can download the CMS survey & cert memo (10-28-NH) at https://www.cms.gov/SurveyCertificationGenInfo/PMSR/list.asp#TopOfPage.