As clinical laboratorians we are taught the importance of the information we provide for clinical decision making. Technology has made it possible to use small sample sizes to generate "numbers" in a very short period of time. Sometimes physicians (and laboratorians) get so seduced by the speed that we forget that numbers are only desirable if they make a positive difference to patient care.
Raw data must be converted into understandable, usable information that is accurate and reflective of the patient it purports to represent.
The Centers for Medicare and Medicare Services (CMS) recently announced that it was immediately removing the requirement that hospitals ensure troponin results be available within 60 minutes of arrival in the ED for acute myocardial infarction patients or chest pain patients.
The requirement dubbed OP-16 is part of the Hospital Outpatient Quality Reporting (OQR) and was slated to be put into effect in 2013. The measure was well intentioned: diagnose chest pain patients as quickly as possible. Rule in or rule out MI. Either admit and treat or discharge the patient. It was a measure designed to improve patient care, free up valuable ED space and save money.
CMS wants to use OQR measures like OP-16 to determine payment for hospitals in 2013, with hospitals that measure up receiving extra payments under a new CMS value-based purchasing scheme. This is a pay for performance model.
The problem in this case is that in July the FDA issued a Class 1 recall on several point of care (POC) troponin kits. They were found to produce inaccurate, unreliable results that could negatively impact patient care and in some cases endanger patient safety.
In an effort to beat the clock many organizations had adopted POC testing for troponin. In some case devices and kits had been sold as "much faster than the lab", or "testing can be performed by anyone."
This is a stark reminder that speed is not everything. Accuracy and validation by trained professionals do count.