Regulatory Profiles

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October 2013 Clinical Laboratory News: Volume 39, Number 10


In This Issue...

COLA Sounds Alarm Over Waived Testing Quality

COLA, a lab accrediting organization, is warning the lab community about growing quality problems at waived testing sites. The organization addressed the Clinical Laboratory Improvement Advisory Committee (CLIAC) at its August 21–22 meeting in Atlanta along with other accreditors, The Joint Commission (TJC), and the College of Pathologists (CAP).

Verlin Janzen, MD, a member of COLA's board of directors, presented COLA's observations about the growing role of waived testing and COLA's evidence of mounting quality problems. According to Janzen, these quality problems exist largely in unregulated labs that rely on waived tests, and have the potential to cause errors and even patient harm. He cited research showing that the number of waived tests has increased from just nine in 1993 to more than 5,400 tests and 110 analytes today. What's more, the quality problems have been exacerbated by technology advances that enable many tests to now be performed on mobile devices by personnel with limited experience and training, Janzen added.

The most common quality challenges that COLA reported included: high staff turnover, failure to adequately train personnel and maintain competency, failure to monitor and respond to quality control, lack of knowledgeable lab directors, failure to document lot numbers and expirations, failure to follow current instrument or kit instructions, pre- and post-analytic errors, waived sites performing non-waived testing, and failure to enter results into electronic medical records.

Janzen recommended more education for Certificate of Waiver site directors and testing personnel. More information about COLA's report is available online.

Report Calls for Better Oversight of RACs

After 3 years of complaints about Medicare's controversial Recovery Audit Contractor (RAC) program, a new report from the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) has found that RACs may not be working as intended.

RACs are supposed to protect Medicare by identifying improper payments and referring potential fraud to the Centers for Medicare and Medicaid Services (CMS). OIG noted in its report that previous Government Accountability Office reports have found problems with CMS's actions to deal with improper payment vulnerabilities. Similarly, prior OIG investigations discovered problems with CMS's response to referrals of potential fraud from RACs, and OIG has in several other cases identified vulnerabilities in CMS's oversight of contractors.

Hospitals have been particularly vocal in their criticism of RACs, which they see as a burdensome and flawed government program. Last year the American Hospital Association asked for an OIG review of RACs, while the association simultaneously joined with four health systems in suing HHS for denying payments.

Hospitals complain that RACs overreach in their demands for large numbers of records from providers, through which they scrutinize for past overpayments. If successful in finding overpayments, RACs get to keep up to 10% of the money they force healthcare providers to give back to the government. But according to hospitals, RACs have been consistently inaccurate and aggressive in their audits.

However, the OIG report does less to bolster the claims of hospitals than it does undermine CMS's credibility with RACs. The OIG report found that in fiscal years 2010 and 2011, RACs identified half of all claims they reviewed as having resulted in improper payments totaling $1.3 billion. CMS took corrective actions to address the majority of these vulnerabilities, but it did not evaluate the effectiveness of these actions, according to OIG. "As a result, high amounts of improper payments may continue," OIG warned. Additionally, CMS did not address referrals of potential fraud that it received from RACs, nor did the agency's performance evaluations include metrics to evaluate RACs' performance on all contract requirements.

More information on the OIG report is available online.

NIH Project Tackles Clinical, Ethical Questions on Sequencing Newborn's Genomes

With genome sequencing speed increasing and cost plummeting, NIH announced a new plan to deal with the medical and ethical quandaries that arise in sequencing babies' genomes. Pilot projects to examine these questions are being funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Human Genome Research Institute (NHGRI), both parts of the National Institutes of Health. Awards of $5 million to four grantees have been made in fiscal year 2013 under the Genomic Sequencing and Newborn Screening Disorders research program. The program will be funded at $25 million over 5 years.

"Genomic sequencing has potential to diagnose a vast array of disorders and conditions at the very start of life," said Alan Guttmacher, MD, director of NICHD. "But the ability to decipher an individual's genetic code rapidly also brings with it a host of clinical and ethical issues, which is why it is important that this program explores the trio of technical, clinical, and ethical aspects of genomics research in the newborn period."

The awards will fund studies on the potential for genome and exome sequencing to expand and improve newborn healthcare, especially in how to use the massive amount of information produced through sequencing, according to NHGRI director Eric Green, MD, PhD. "We are at a point now where powerful new genome sequencing technologies are making it faster and more affordable than ever to access genomic information about patients," he said. "This initiative will help us better understand how we can appropriately use this information to improve health and prevent disease in infants and children."

Programs currently screen almost all of the more than 4 million infants born in the United States each year. Until now, the testing of DNA has not been a first-line newborn screening method, but has been used to confirm the screening results of some disorders, such as cystic fibrosis.

Each of the new awards will consist of three parts: genomic sequencing and analysis; research related to patient care; and the ethical, legal, and social implications of using genomic information in the newborn period.

More information about the project is available online.

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