Unlike more traditional forms of clinical lab testing, molecular diagnostics can provide an accurate diagnosis in a matter of hours or minutes.
Miller is the lead author of the updated guide published in Clinical Infectious Diseases that's intended to help healthcare providers keep up with the latest advances in rapid molecular testing. Miller said the recommendations could help healthcare providers develop a more standardized approach for handling specimens for microbiology testing to lower the risk of a misdiagnosis or wrong treatment being delivered based on a faulty result.
"In microbiology we are dealing with organisms that are living—it's not like just drawing a tube of blood or taking a sample that goes into a machine," Miller said. "There's a lot of interpretive judgment that is required in order to provide an accurate diagnosis—the only way we can do that is to have a specimen that has been appropriately selected, collected and transported."
Mistakes made in the handling of laboratory specimens prior to testing make up 32% to 75% of all laboratory errors, according to a 2012 analysis published in the journal Lab Medicine.
Laboratory error is the cause of approximately 1 in every 330 to 1,000 preventable harmful events that happen to patients while they are in a healthcare setting.
A 2016 study published in the American Journal of Clinical Pathology found that errors in specimen labeling and collection or missing specimens at New York-based Northwell Health Labs could cost between $200 and $2,000 per incident.
Microbiology tests to detect infection have accounted for a growing proportion of costs in recent years. According to a 2016 report from HHS' Office of the Inspector General, Medicare payments for microbiology tests increased consistently from $427 million in 2014 to $570 million in 2016.
Infectious disease physicians are well-versed in properly collecting and sending off viable testing samples. But Miller said many other types of healthcare professionals may not realize the complexities involved in conducting such tests and getting an accurate result.
Miller said producing an accurate test result using molecular diagnostics requires healthcare providers to know the right types of specimens to collect, knowing the right equipment to store specimens in, and knowing the right type of transportation needed to successfully get an uncontaminated sample to the lab.
Oftentimes samples become contaminated when a healthcare provider fails to properly clean an area prior to drawing blood or scraping a wound. The guide also recommends providers specifically label where on the patient's body the specimen came from to help lab testers rule out microbes in the culture sample that are not problematic.
Miller stressed that properly managing molecular testing specimens can have a large impact on the quality of patient care. An inaccurate diagnosis caused by an improper handling of a specimen could result in poorer health outcomes or harm caused by medical error.
Some important key points on proper protocols in handling lab specimens that were highlighted in the guide included rejecting all specimens of poor quality; collecting specimens prior to administering antibiotics; and letting the laboratory, not the medical staff, set technical policy.
Miller said properly managing specimens is especially important when dealing with infections that require antibiotics in order to pinpoint which drug will be most-effective and reduce the need for multiple therapies.
"We want targeted therapy where the right test and the right time is absolutely critical," Miller said.
