Ironing Out Inconsistencies with GCP Auditing

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As the scrutiny of pharmaceutical organisations continues to rise, the pressure to keep standards high remains greater than ever, something evidenced in the fact that 20 per cent of all clinical trials are now subject to  (GCP) regulatory audits.

As inspectors' expectations continually evolve, multinational organisations are striving to meet them but, inevitably, standards sometimes fail.

A new study looking at how hospitals identify paediatric patients who develop catheter-associated bloodstream infections, has found significant inconsistencies in the methods used to report the number of patients who develop them.

The study, led by Dr. Matthew Niedner, assistant professor of Pediatrics and Communicable Diseases at U-M CS Mott Children's Hospital, was conducted by the National Association of Children's Hospitals and Related Institutions Pediatric Intensive Care Unit Focus Group.

Dr. Niedner said that there is an "intense amount" of attention being placed on measures of quality performance that have significant implications in pay-for-performance and reimbursement.

"What you have is a desire to measure quality but a lack of perfect measures. Measures are often 'good enough' to enable quality improvement, but can leave undesirable ambiguity when used comparatively as a metric of clinical performance," he explained.

The study appears in the October issue of the American Journal of Infection Control and highlights how, with an increasing number of regulatory warnings relating to record keeping and informed consent, it is more crucial than ever to comply with GCP and be inspection ready.
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As bloodstream infections (BSIs) are the most common hospital-associated infections in paediatric intensive care units (PICUs), they are a significant source of in-hospital deaths, increased length of stay and added medical costs.

Both adult and paediatric patients who have catheters inserted into their blood vessels face an increased risk of developing an infection along the invasive plastic devices, while the infections can become deadly as they spread into the bloodstream - something the study focused on.

Altogether, 146 respondents from five professions in 16 PICUs completed surveys with a response rate of 40 per cent, with all ten infection control departments reporting inclusion or exclusion of central line types inconsistent with the Centers for Disease Control and Prevention CA-BSI definition.

In addition, they reported half calculated line-days inconsistently, and only half used a strict, written policy for classifying BSIs. Infection control departments also reported substantial variation in methods, timing and resources used to screen and adjudicate BSI cases.

All of the surveyed infection control practitioners in the study said they used the Centers for Disease Control and Prevention's definition for CA-BSI, but none actually did, according to Dr. Niedner.

He pointed out that this has "significant implications" in the era of mandatory public reporting and pay-for-performance.

As the study also showed that more aggressive surveillance efforts correlate with higher catheter-associated bloodstream infections rates, it suggests that the harder people look for CA-BSIs, the more likely they are to find them, the expert suggested.

"From an internal perspective, you want an aggressive surveillance system that is inclusive of all possible cases, but from a public reporting or pay-for-performance standpoint, you'd like to exclude as many cases as you can," Dr. Niedner said.

He added that, as there are no definitive national standards regarding CA-BSI surveillance at the clinical practice level, it leaves "wiggle room" that pits hospital economics and reputation against quality improvement teams.

According to the expert, many problems become more manageable when procedures are standardised.

"Various professional bodies have put forward recommendations for CA-BSI surveillance, but not at the level that will give it real traction. It's going to take a national entity endorsing standardised surveillance practices to improve the validity of institutional comparisons," he explained.

In the coming months, improving quality and GCP standards through understanding regulatory expectations and achieving a risk-based approach to auditing and inspection preparation will be top of the agenda for many firms.

However, as Dr. Niedner's study suggests, there is a long way to go before all clinical trials pass the ever-rigorous GCP audits.