Clinical laboratories: total protein test: authorization.
The bill's modifications are significant for California's healthcare framework. By allowing trained personnel without extensive credentials to conduct these tests, AB 392 aims to enhance efficiency within plasma collection centers. The changes are intended to reduce potential delays in testing, which could impact donor services and patient care. The responsibility for maintaining the integrity of test procedures is shifted towards the licensed centers, which are required to implement additional supervisory protocols as outlined in the legislation.
Assembly Bill No. 392, authored by Nazarian, amends Section 1246.7 of the Business and Professions Code to modify the authorization for performing total protein tests in licensed plasma collection centers. Previously, the law allowed such tests under certain conditions set to expire on January 1, 2023. The bill now indefinitely extends this authorization, aiming to streamline the testing process while establishing standardized procedures for those performing the tests using a digital refractometer. It focuses on ensuring compliance with both state and federal regulations, particularly the Clinical Laboratory Improvement Amendments (CLIA).
Discussion around AB 392 has generally been supportive, particularly among healthcare providers and organizations focused on improving blood and plasma donation processes. Advocates praise the bill for its potential to improve access and speed to critical healthcare testing. However, some concerns were raised regarding the adequacy of training and oversight of personnel, reflecting a tension between increasing access to services and ensuring patient safety and quality of care. Opponents emphasize that while the intent is positive, the execution must not compromise laboratory standards.
Key points of contention revolve around the qualifications and training of individuals authorized to conduct the tests. While the bill outlines specific training requirements, some stakeholders argue that these may not be sufficient to ensure quality and safety in testing procedures. Additionally, the bill's decision not to provide reimbursement to local entities for the costs associated with implementing the new measures has raised eyebrows, suggesting that local governments may be shouldering unanticipated financial burdens as they adjust to the new regulations.