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A quirk in insurance reimbursement made drug testing by mass spectrometry a lucrative business. The opioid crisis increased the need for urine drug tests, and the financial incentive was so strong that many pain doctors set up their own in-house physician office laboratories to claim their share of the profits.

Ask the Expert

As miRNA-based diagnostics start to enter the clinic, labs should be aware of the range of challenges these tests pose, such as results that are difficult to interpret and the susceptibility of miRNA levels to pre- and post-processing factors.

Bench Matters

Federal Insider

In a speech to state Medicaid directors, CMS Secretary Verma said the Trump administration views Medicaid as a program that should help able-bodied adults "move on and move out." Verma also announced that CMS will create the first-ever scorecards that will track state and federal Medicaid spending.

Focus on Mass Spectrometry

As the use of liquid chromatography-mass spectrometry has increased, clinical labs have sought to improve efficiency by employing alternative calibration strategies to reduce the number of calibration standards. While CLIA guidelines require biannual calibration at a minimum, no regulation requires that labs generate a calibration curve with every assay. This…
While MALDI-TOF MS is a robust system for microorganism identification, it is not infallible. For example, it cannot discriminate reliably between closely related microorganisms, and incorrect identifications can occur from user error, analysis of mixed cultures, and other reasons.

Industry Playbook

Dell Medical School at The University of Texas in Austin has created a new Department of Diagnostic Medicine, which is developing partnerships with local clinical practices and community physicians to improve accuracy in diagnoses, make testing more convenient and efficient, lower costs, and broadly integrate patient health data with electronic…

Mini Review

Multiple independent and highly powered studies suggest that non-fasting lipids are similar (or better) than fasting measures for predicting risk of cardiovascular disease. Furthermore, routine non-fasting lipid panels can accommodate a majority of patients without the need for separate fasting visits.

Patient Safety Focus

The practice of multi-strip vial use has come into focus as yet another potential source of contamination for patients undergoing blood glucose testing, along with the well-documented risks of sharing blood glucose meters and capillary puncture devices.
Rarely do conflicts between patient safety and patient satisfaction have easy answers. However, both care providers and laboratory staff can find a way forward by empathizing with patients and explaining that their healthcare facility is patient-centered, but not patient-directed when it comes to the lab.

Regulatory Roundup

Special Supplement

A 55-year-old man's laboratory results didn't make sense. Biochemically he had a clear case of severe Graves' disease, an immune disease that causes overproduction of thyroid hormones, but he had no clinical symptoms. On further questioning, the man revealed he had taken very high doses of biotin--about 5,000 to 10,000…

The Sample

Repeat quantitative, reverse transcription polymerase chain reaction testing in pregnant women with confirmed Zika virus infection showed that in some, the viral load in their urine disappeared and later returned. These findings suggest a single negative test may not be sufficient to reassure women about their Zika status.