California has become the Golden State for COLA. After an arduous application process that lasted for nearly two years, COLA became the first private firm in the state’s history to earn deeming authority for both federal as well as California state lab certification. COLA, which was known as the Commission on Office Laboratory Accreditation when it was founded in 1988, also holds deeming authority for both state and federal inspections in five other states where there is a complimentary state inspection, including populous ones such as Florida and Pennsylvania. But California is the most populous state by far where it operates. “This approval validates COLA’s . . . commitment to patient safety,” said Douglas Beigel, COLA’s chief executive officer. “This is particularly important in California, where laboratories face a complex set of state laws and regulations concerning quality activities, as well as the personnel who can supervise and perform testing.” California lawmakers decided to farm out deeming authority to private operators after the Laboratory Field Services Division of the California Department of Public Health (CDPH) began to fall behind in its semiannual inspection and accreditation process. Although legislation to allow private organizations to take over the process was signed into […]
California has become the Golden State for COLA. After an arduous application process that lasted for nearly two years, COLA became the first private firm in the state’s history to earn deeming authority for both federal as well as California state lab certification.
COLA, which was known as the Commission on Office Laboratory Accreditation when it was founded in 1988, also holds deeming authority for both state and federal inspections in five other states where there is a complimentary state inspection, including populous ones such as Florida and Pennsylvania. But California is the most populous state by far where it operates.
“This approval validates COLA’s . . . commitment to patient safety,” said Douglas Beigel, COLA’s chief executive officer. “This is particularly important in California, where laboratories face a complex set of state laws and regulations concerning quality activities, as well as the personnel who can supervise and perform testing.”
California lawmakers decided to farm out deeming authority to private operators after the Laboratory Field Services Division of the California Department of Public Health (CDPH) began to fall behind in its semiannual inspection and accreditation process. Although legislation to allow private organizations to take over the process was signed into law in 2009, the complexity of California’s regulations and putting together a certification process for outside firms to obtain deeming authority took years.
Beigel said the organization also had to undergo the arduous process of crosswalking every facet of its accreditation program to California’s set of existing laboratory regulations.
“It was an exhaustive list, probably the most detailed list of any state,” Beigel said. “We had to ask ourselves how to write appropriate deficiencies. We talked about surveyor guidelines.” He added that the organization’s ISO 9000 certification was a big help in getting through the process.
Moreover, Beigel noted that California officials did not want to merely accept what he termed a “global statement” of how it would go about the deeming process. “They wanted to make sure we accepted their fundamental approaches to laboratory medicine,” he said.
CDPH spokesperson Matt Conens confirmed that COLA is the first private organization in California to obtain deeming authority for labs. Applications have also been submitted by the College of American Pathologists, the Joint Commission, and the American Association of Blood Banks. Those applications remain pending.
The deeming process could prove fairly lucrative for COLA. In addition to the fees labs must pay to the CDPH to maintain their ongoing certification, COLA charges anywhere from $1,384 to certify a low test-volume lab to well over $5,950 for labs that perform more than 1 million tests annually.
A total of 432 labs in California have chosen COLA to conduct their federal accreditation inspections and reviews, and hundreds of others have the option of doing so in the future, according to a spokesperson with the organization. COLA has not yet hired any new employees to supervise the compliance process in California, Beigel said.
Under California law, COLA is also obligated to provide educational services to California’s laboratories, the only requirement of its kind in the nation, according to Beigel. As a result, COLA will offer Web-based e-learning tools on issues such as safety and compliance, as well as ongoing webinars. The organization also held a summit in San Francisco late last month on laboratory medicine and its importance in patient outcomes.
“We are just getting started on getting the word out” regarding COLA’s new role in California, Beigel said.
Takeaway: The most populous state is turning over laboratory accreditation duties to private entities, which will likely compete for this business over time.
