Clinical Laboratory TechnologyApplication of the Chapter
Section § 1240
This law section makes it clear that nothing here allows anyone to practice medicine or provide physician services. It doesn't change any existing rules about practicing medicine and still allows non-medical tests that aren't mentioned elsewhere.
Section § 1241
This law covers clinical labs in California or those working with samples from California. It sets rules for who must follow these guidelines and outlines exceptions. Labs owned by the U.S. government, public health labs, those doing forensic work, and labs focused solely on research or teaching purposes are exempt. Other exclusions include labs handling certified drug tests, places testing diabetic children's blood glucose with proper registration and guidelines, people using over-the-counter test kits on themselves or their children, certain emergency medical technicians, and chiropractors doing specific urine tests for Department of Transportation exams. Special conditions apply, like needing waivers for some tests or following strict procedures for lab processes and reporting.
Section § 1241.1
Section § 1242
If you have the proper license to conduct tests in a clinical lab, you are also allowed to perform certain medical procedures like skin tests, drawing blood through various methods, and other tests as per regulations. But you need to have specific authorization as outlined by laws related to healthcare professions.
Section § 1242.5
This law allows certain certified lab personnel to perform blood draws, like venipuncture, arterial, or skin punctures, by following regulations set by the department. This is specifically for the purpose of blood withdrawals and lab tests.
Section § 1242.6
This law explains who is allowed to perform procedures to withdraw blood, like drawing blood through veins, arteries, or skin puncture. Registered nurses can do this if approved by a doctor or dentist. Licensed vocational nurses can also do it if they're approved by a doctor, have received special training, and passed either an instructed course or demonstrated their skills. Respiratory care practitioners can withdraw blood following similar approvals by a doctor.
Section § 1243
This law allows students from approved colleges, universities, or training schools to perform certain medical procedures like drawing blood, as part of their training. These procedures must be supervised by a licensed professional or physician.
Section § 1244
This law permits programs to offer general health screenings but sets clear rules to ensure safety and proper procedure. These programs can’t diagnose diseases but can screen symptom-free individuals for chronic issues and direct them to licensed care providers. The screenings must follow specific guidelines, like only using approved devices and methods, ensuring blood and urine testing is done safely and without undue risk. There must also be clear communication with participants about the risks and limitations of these screenings. A supervisory committee must oversee the program, and certain trainings and protocols need to be in place. Additionally, only authorized personnel can perform blood collection via finger prick, and any lapse in these requirements means the program cannot operate. Clinical labs and health fairs can also conduct these assessments if they comply with the outlined regulations.
Section § 1244.1
If you're going to run a nondiagnostic general health assessment program, you need to inform the local health officer of your plans 30 days before you start. This includes telling them where and when the program will happen, what kind of health checks you'll be doing, and making sure it complies with the rules. If there are any changes to your plans, like a new location or different time, you must inform the local health officer at least 24 hours before the changes take effect.
Section § 1244.3
This law section says that local health officers or their authorized representatives, like public health lab directors, are in charge of enforcing the rules in Sections 1244 and 1244.1. Additionally, it clarifies that the department can still take any needed actions to ensure public health and safety.
Section § 1244.4
This law states that local enforcement agencies can charge up to $100 for filing documents and related work connected to certain sections of the law, unless increased by inflation, based on the California Consumer Price Index. The money collected goes into local government funds and must be used to support the specific sections mentioned.
Section § 1245
This law explains who can perform blood gas analysis. To do this, a person needs a high school diploma and must work in a clinic or hospital under the supervision of a licensed physician. They must also submit the results to the supervising physician for interpretation. If someone wants to perform high-complexity blood gas analysis after September 1, 1997, they need an associate degree related to pulmonary function. This law does not allow those not already authorized to withdraw blood, and it doesn’t apply to licensed respiratory care practitioners who have their own rules.
Section § 1246
California requires anyone working in a clinical lab, who performs certain tasks such as drawing blood, to have a certification as a phlebotomy technician. This certification involves meeting certain education and training standards, including hands-on experience with blood draws and completing continuing education. A certified phlebotomy technician can perform tasks like venipunctures under supervision, but cannot manage intravenous infusions or work with central catheters. Specific rules apply when drawing blood for forensic purposes or under insurance requirements with supervision defined as being available remotely if necessary. The state also sets regulations for approving training programs and national certification agencies, and it mandates fees for applying and renewing certifications.
Section § 1246.5
In California, anyone can request certain lab tests, which licensed or public health labs are allowed to perform. These labs must follow specific regulations and be registered if the test is considered waived under federal law. Individuals can receive their test results directly, which should be easy to understand and highlight if a doctor should be consulted. The law specifies tests like pregnancy, glucose, and cholesterol, and includes any FDA-approved test that can be bought over-the-counter, but excludes tests that are just sample collection kits.
Section § 1246.7
This law allows a person to use a digital refractometer to perform total protein tests in licensed plasma collection centers if specific conditions are met. These conditions include having a high school diploma or equivalent, sufficient training, and certification from a recognized authority. The person must work under the supervision of specific licensed professionals who are present onsite. The digital refractometer must operate within 30 feet of the donor and it needs to meet certain technical standards. The results must be recorded accurately, and the device must be used according to strict procedures without needing extensive maintenance. Evaluations of the person's competency are required every six months, and documentation must be maintained and available to authorities upon request.