If you are even somewhat familiar with clinical laboratory issues, chances are that you know about the CDPH Laboratory Field Services. If not, don’t fret. The LFS is made up of 5 sections, including Laboratory Licensing and Registration, Personnel Licensing, Clinical Laboratory Improvement Amendment, On-Site Licensing, and Blood and Tissue Bank Licensing and Cytology Surveillance. Let’s take a look at these divisions and the LFS organization as a whole.
What is the CDPH Laboratory Field Services?
In a nutshell, the LFS branch of the CDPH is a provider of oversight for clinical and public laboratories, and the testing personnel within. They are in charge of clinical laboratory issues in California—LFS inspects, audits, and investigates all kinds of licensed laboratories on a regular basis. The organization’s overall purpose is to provide equality in California laboratories in terms of protecting individuals being tested on. This is done through providing enforceable certification and registration, along with an effective renewal and review process. Interested in general registration and license fees? The CDPH Laboratory Field Services provides a useful fee schedule here:
Laboratory Licensing and Registration
This section of the LFS is in charge of reviewing clinical laboratory license and registration applications. The LFS is tasked with ensuring California law compliance is upheld. The Laboratory Licensing and Registration section also issues licenses and registration, while reviewing and upholding satisfactory levels of proficiency testing.
Why is this LFS section important? Any facility that performs moderate to high testing in terms of complexity, is required to have state licensure. If a medical facility is merely performing waived and provider-performed microscopy procedure testing, a State registration is acceptable. The Laboratory Licensing and Registration division is also responsible for administering fees for these initial certifications, along with license and registration renewal expenses.
This division of the CDPH Laboratory Field Services is tasked with overseeing standards regarding mandated education, training, examination, licensing, certification, and competency for California laboratory personnel. Currently, more than 65,000 licensed personnel are involved with the LFS in California. Initial and renewal licensure and certification is handled by the Personnel Licensing section. This includes licensing and certifying phlebotomy technicians. The division oversees approximately 600 training programs. Random audits of licensees occur, with the purpose of ensuring continuing education requirements are being completed. As with the Laboratory Licensing and Registration section, the Personnel Licensing section is in charge of any fees related to licensing, certifying, and renewing individual’s qualifications.
Clinical Laboratory Improvement Amendment
The Clinical Laboratory Improvement Amendment (CLIA) section of the LFS takes a lead role in establishing quality standards for clinical laboratory testing in order to ensure that the most effective testing methods are being performed. Accuracy, reliability, and timeliness are three key factors the CLIA takes into account when measuring test quality—they have the goal of maintaining high standards so that a test site does not have a negative effect on any particular results. The CLIA section maintains a partnership with the federal Centers for Medicare and Medicaid Services. Inspections are conducted by the CLIA in order to ensure federal guidelines are being followed in California laboratories. More than 800 laboratories are inspected each year.
This section is in charge of overseeing clinical laboratories through on-site inspections. The On-Site Licensing division also constantly monitors proficiency testing performance. Facilities affected include physician offices, clinics, hospitals, independent laboratories, and public health laboratories. While conducting initial and routine inspections, the On-Site Licensing division also investigates complaints made by outside parties. This is certainly the most “hands-on” section of CDPH laboratory field services.
Blood and Tissue Bank Licensing
This division is made up of three components. They include the Blood Bank Program, the Tissue Bank program, and the Cytology program. First, the Blood Bank program provides licensure and monitoring to about 350 facilities. Blood donors and recipients of blood are protected by this program, as they can be assured that their corresponding facilities are in compliance with California’s Health and Safety Codes.
The Tissue Bank program oversees surveillance of facilities associated with collecting, processing, storing and distributing human tissue from living and deceased donors into other human beings. Approximately 850 tissue banks are licensed in California. Finally, the Cytology program surveys cytotechnology laboratories. It makes sure that cytology slides are collected, stained, and screened in a proper fashion. 300 laboratories that specialize in cytotechnology are licensed by this program.
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