As they are in most corners of the health care industry in this era of reform, changes are coming to medical laboratories. The way lab tests are ordered, the way results are released, the way labs are accredited and ultimately the way tests are administered are all changing.
California will be — pardon the expression — the testing ground for many of these changes.
For the first time, California has approved a private organization to help oversee medical laboratories. The state Department of Public Health granted “deeming status” to COLA, a 26-year-old not-for-profit based in Maryland. Known as the Commission on Official Laboratory Assessment when it was formed in 1988, COLA will work with state officials to determine if some California laboratories are meeting federal and state requirements in conducting lab tests. Deeming authority is tantamount to accrediting lab facilities.
California’s partnership with COLA is believed to be the first of its kind in the country.
“We are in a very unique position in California, the way we’re able to work with labs to make sure they’re meeting state and federal regulations,” said Doug Beigel, CEO at COLA.
“In this new era with electronic health records and some 30 million more people insured under the ACA, laboratory medicine will become much more apparent than it is now. Somewhere between 70% and 80% of medical decisions are based on lab tests and that number is only going to grow. We’re very excited about our new role in California, which has been considered a leader in this area,” Beigel said.
Three other accrediting organizations — the College of American Pathologists, the Joint Commission on Accreditation of Hospitals and the American Association of Blood Banks — also applied for deeming authority in California. Those applications are reportedly still under consideration.
In a written response to questions for this story, DPH spokesperson Ronald Owens said the new partnership “will ensure that COLA’s accredited laboratories are inspected every two years and that the laboratories comply with state and federal regulations that ensure that laboratory test results are accurate and reliable.”
“Prior to the approval of COLA, the state was responsible for inspecting the COLA laboratories every two years,” Owens said.
Laboratory Accreditation Changes Years in Making
In 2008, the Laboratory Field Services division of California’s DPH was falling behind in its job of surveying and overseeing clinical labs. The independent Bureau of State Audits issued a report criticizing the state’s licensing and inspection of clinical labs and lab personnel. The Legislature passed a bill redesigning state oversight of clinical labs and opening the doors for independent contractors to help with accreditation.
Then-Gov. Arnold Schwarzenegger (R) signed SB 744 by then-state Sen. Tony Strickland (R-Thousand Oaks) in October 2009. COLA and other accreditation organizations began working with California officials when the law took effect.
“California has a generally high bar in laboratory regulations,” said Richard Cross, government and external manager for COLA. “From a process and oversight perspective many parts of the country look to California for leadership.”
California is “the only state in the union that has required COLA to provide education to laboratories and we’re overjoyed at that,” Beigel said. “We see education as a very big part of our mission and the fact that California sees it that way as well is great for us.”
Clinical laboratories, like other parts of the health care industry, are facing a shortage of workers. Some estimate as many as 40,000 medical technician jobs are vacant across the U.S. because of a scarcity of trained applicants.
Some state legislatures — including California’s — are working on broadening scope-of-practice parameters for some health providers such as optometrists and nurse practitioners to help take pressure off the understaffed workforce. Those changes could also have an impact on how clinical lab tests are ordered and carried out.
Medical laboratory accreditation experts will convene in San Francisco next week for a leadership summit hosted by COLA.
New Federal Rules for Getting Lab Results
Two months ago, HHS issued new regulations governing the release of laboratory test results. Patients are now allowed direct access to their test results without having to go through a physician. Laboratories are now required to release test results to patients upon request. Patients can get results by phone, through the Internet and with smartphone applications.
The change amends the privacy rules under the Health Insurance Portability and Accountability Act and the Clinical Laboratory Improvement Amendments of 1988, which required patients to get lab results through a physician.
“We think that’s a good thing, generally,” Beigel said. “Any time you have patients engaged in the conversation about their health it’s a good thing. Generally, the more engagement the better.”
The new regulations “will shine a light on the importance of laboratory medicine,” Beigel said.
State law in California already allowed Californians direct online access to some lab results with approval from physicians. The new federal rules will supersede state law.
More Changes Likely
In addition to changes in how laboratory tests are regulated and how the results are delivered, fundamental changes in how some tests are administered may also be on the horizon.
Generally, clinical lab tests are divided into two categories — simple ones like pregnancy tests and strep throat swabs and moderate-to-complex ones like blood tests and urinalysis. Because of changes in technology, the line dividing simple and complex is blurring.
“We believe in the not-too-distant future FDA will approve a testing device for CBCs (combined blood count) that could change the landscape significantly,” Beigel said.
A portable, do-it-yourself blood testing kit “has been talked about for some time,” Beigel said.
Moving blood tests out of clinical laboratories and into patents’ hands would “eliminate about 85% of what we do,” Beigel said.