Federal Law Allows Pharmacy Staff to Administer COVID-19 Vaccinations, Prevents Lawsuits
The U.S. Department of Health and Human Services (HHS) has issued guidance allowing pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 vaccines when available — if certain training, recordkeeping, reporting, and other requirements are met. HHS previously used its authority under the Public Readiness and Emergency Preparedness Act (PREP Act) to prohibit lawsuits against health care providers who provide COVID-19 vaccinations.
As a reminder, the PREP Act authorizes the HHS Secretary to issue a declaration (which he has done here) that provides immunity from liability for the manufacture, distribution, administration, or use of “medical countermeasures,” except for claims involving willful misconduct. A medical countermeasure is a drug, device, or biological product that is manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic. To be a covered countermeasure, a product must be approved, cleared, or authorized for emergency use by the Food and Drug Administration or licensed under the Public Health Service Act.
Immunity covers claims under tort or contract law, as well as claims related to compliance with state/local laws. Any lawsuit alleging an exception to PREP immunity must be brought before a special three-judge court in U.S. District Court in Washington, DC. To win, the plaintiff must prove that willful misconduct was the proximate cause of death or serious injury by clear and convincing evidence. The PREP Act also establishes a program to compensate individuals for serious physical injury or death caused by a covered countermeasure.
HHS Makes Hospitals’ COVID-19 Reporting Compliance Public
In an ongoing effort to publicize data related to COVID-19, HHS has released a report on hospital reporting compliance. For most California hospitals, the compliance reports are based on data they enter daily into the CHA COVID-19 Tracking Tool, which the state then uploads on hospitals’ behalf into TeleTracking. More information and key points hospitals should be aware of are available here.
CDPH Revises Hospital Visitation Recommendations, SNF Visitation Requirements
On Oct. 23, the California Department of Public Health (CDPH) released revised recommendations for hospital visitors and support person policies in All Facilities Letter (AFL) 20-38.5. CDPH recommends that health facilities, including hospitals, in red, orange, and yellow tier counties under the Blueprint for a Safer Economy framework allow one visitor per patient at a time. These are not requirements, but rather recommendations. To learn more about hospitals’ options for visitation guidelines — including state and federal laws related to hospital visitation as well as these CDPH recommendations — register for CHA’s member webinar, COVID-19: Hospital Visitor and Support Person Laws and Guidelines Webinar, Oct. 30 from 1 to 2 p.m. (PT).
Also on Oct. 23, CDPH released AFL 20-22.5, which updates the agency’s visitation guidance for skilled-nursing facilities to align with the Centers for Medicare & Medicaid Services’ QSO-20-39-NH. This includes skilled-nursing facility requirements to facilitate visitation of residents.
New Federal Action Network to Provide Support and Resources to SNFs
Skilled-nursing facilities are encouraged to enroll in the ECHO National Nursing Home COVID-19 Action Network, an interactive community-of-practice network that aims to advance improvements in COVID-19 preparedness, safety, and infection control. Nursing facilities are eligible to receive a $6,000 payment for participation in the program, which will launch nationwide the week of Nov. 9. Health Services Advisory Group and the Stanford School of Medicine are partnering to deliver the program, which is supported by the federal Agency for Healthcare Research and Quality in collaboration with the Institute for Healthcare Improvement.
Weekly sessions will provide practical information, skills, and resources needed to protect residents and staff from COVID-19. A minimum of two staff members must participate in weekly Zoom sessions for 13 of the 16 weeks to be eligible for the $6,000 payment. Interested facilities must sign up here by Nov. 3. Additional information is available in these FAQs.
Next CDPH Call for Health Care Facilities: Nov. 3, 8-9 a.m. (PT)
Dial: (844) 721-7239
Summary of Oct. 20 CDPH Call
CDPH has provided a summary of its recent weekly call with health care facilities.