Diagnostic labs are a valuable part of the health care marketplace. These labs can offer a variety of services within hospitals and as stand-alone facilities. Those who are interested in joining this marketplace, or who are relatively new to the health care industry, can benefit from a basic understanding of the accreditation process.
Why is accreditation important?
The Texas Department of Health and Human Services requires laboratories comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). It is important to note that labs are not licensed by the state in which they operate. Instead, the Secretary of the DHHS directs state agencies to determine if health care entities meet federal standards.
What organizations are responsible for accreditation of labs?
The Joint Commission for the American Association of Blood Banks, College of American Pathologists, Accreditation of Healthcare Organizations, American Osteopathic Organization, Commission on Office Laboratory Accreditation and American Society of Histocompatibility and Immunogenetics are organizations which offer accrediting programs.
In some cases, the process for accreditation within these programs is more stringent than the federal government’s inspection program. In a recent example, the Texas Health Hospital Rockwall laboratory received accreditation through the College of American Pathologists. This program is recognized by the feds as one with “equal-to or more-stringent-than” inspections compared to its own. As such, the facility likely meets or exceeds federal standards.
What are the applicable federal standards?
The exact standards may vary depending on the organization. Federal regulations generally require labs to abide by standards from the CLIA and FDA as well as OSHA. It is also important to note that state licensure requirements may also apply. These requirements are often present for labs as well as ambulatory surgical centers, psychiatric hospitals, narcotic treatment centers, rural health clinics and special care facilities, to name a few.
How can I better ensure my lab follows federal and state regulations?
You can take proactive actions to help better ensure compliance. Internal audits are one option. This can help leadership to recognize and address any potential issues before they become a serious concern.