Previously, sites that collect medical specimens but do not perform clinical tests, known as 'Specimen Collection Sites,' lacked oversight from federal Centers for Medicare and Medicaid Services (CMS) or the California Department of Public Health (CDPH).

The ordinance mandates specimen collection sites to partner with a government entity, licensed health care provider, or educational institution, establish hygiene, sanitation and privacy standards, and comply with the Health Insurance Portability and Accountability Act (HIPAA).

Violation of these new specimen collection standards will be considered a public health nuisance and subject to administrative penalties by the Department of Public Health.

The purpose of these changes is to ensure the protection of privacy and compliance with health and safety protocols for individuals' health information at Specimen Collection Sites, which have become increasingly common since the COVID-19 emergency.

The text does not provide explicit details on the approval process for this ordinance within the provided excerpts.

The Department of Public Health is responsible for imposing administrative penalties for violations of the new standards.