In January 2017, the California Board of Pharmacy (BoP) established new regulatory requirements for hospitals performing sterile compounding. The California Department of Public Health (CDPH) last month released the attached All Facilities Letter 18-20, which clarifies requirements for new or remodeled pharmacy clean rooms and use of mobile sterile compounding units in general acute care hospitals. According to the letter, hospitals must obtain CDPH approval for all new or remodeled pharmacy clean rooms under the hospital’s license. Hospitals must also obtain CDPH approval — including program flexibility approval — to temporarily use mobile sterile compounding units.
CDPH reminds hospitals that, because of the multiple levels of review by state entities, they must allow sufficient time for all required approvals. CDPH advises hospitals to submit applications to the Centralized Applications Unit 120 days prior to when the new or remodeled pharmacy is anticipated to be completed, and clearly mark that the application is for sterile compounding. In addition, CDPH advises hospitals to contact the CDPH Pharmacy Consultant Unit at LNCPharmCleanRoom@cdph.ca.gov 90 days prior to anticipated completion.
The California Department of Public Health has released All Facilities Letter 18-21, attached, addressing lesbian, gay, bisexual and transgender (LGBT) training for certain staff. By Aug. 1, congregate living health facilities and skilled-nursing facilities must provide LGBT training at least once every two years, and must train new staff within six months of hire. These requirements apply to registered nurses, licensed vocational nurses, certified nurse assistants and medical directors employed by the facility. The letter also outlines training content and method requirements.
As previously reported in CHA News, a new state law requires health care providers diagnosing or treating Parkinson’s disease patients to report each case to the California Department of Public Health (CDPH) beginning July 1. To assist providers in complying with this requirement, CDPH has announced a series of free informational meetings that will detail reporting of disease information. The first meeting will be held May 23 from 9 a.m. to noon in Los Angeles. The second meeting will be held May 29 from 1 – 4 p.m. in Sacramento. Space is limited; interested participants are encouraged to register soon.
The California Department of Public Health reminds providers that it has issued specific contact instructions during an emergency or disaster-related occurrence. As outlined in All Facilities Letter 17-06, hospitals must contact the local licensing and certification district office if an event affects their facility and results in an evacuation, transfer or discharge of patients.
For after-hours reporting — or if the local licensing and certification district office is non-operational due to an emergency or disaster — facilities outside of Los Angeles County should contact the State Office of Emergency Services Warning Center at (916) 845-8911 and ask that it notify the CDPH duty officer. Facilities in Los Angeles County should contact their county operator at (213) 974-1234 and ask that the on-call Health Facilities Inspection Division supervisor be notified.
The California Department of Public Health today released a comprehensive online tool that publicly displays a comprehensive set of data related to applications for licenses and reports of change. It includes all data since the Centralized Applications Unit became operational statewide on April 1, 2017, and is searchable by application type, facility type and district office. It also includes application volume and CDPH performance metrics, a map of received applications and an application detail file.
CHA has advocated for the public release of this information and will work with CDPH to provide a members-only call to review the data. More information about the call will be provided in CHA News once it is available.
The California Department of Public Health (CDPH) has issued the attached All Facilities Letter (AFL 18-19) providing direction for hospitals requesting program flexibility for regulatory requirements found in Title 22 of the California Code of Regulations. CDPH’s Licensing and Certification Program grants program flexibility if the requesting facility demonstrates its ability to meet related statutory requirements found in the Health and Safety Code. The facility must also supply adequate supporting documentation that the proposed alternative to regulatory compliance does not compromise patient care.
When requesting flexibility, hospitals must submit CDPH form 5000 to their local CDPH district office. The AFL includes details on what must be included with the request, as well as specifics about the district offices’ responsibility and process. Approved requests for program flexibility will specify an expiration date and are subject to specific terms and conditions.
The AFL also notes that facilities seeking program flexibility to address health care emergencies or unforeseen events — such as an infectious disease outbreak, disaster or mass casualty incidents that may lead to a rapid influx or “surge” in patients — should refer to AFL 18-09 for an alternative application process.
Under AB 2325 (Chapter 354, Statutes of 2016), pathologists will be required to electronically report cancer diagnoses to the California Cancer Registry (CCR) beginning Jan. 1, 2019. To help providers meet this requirement, the CCR has released an implementation guide defining reporting requirements as well as a standardized format for reporting. Pathologists and pathology software providers will need to review the guide and register through the CCR online portal to meet reporting requirements. More information is available at www.ccrcal.org/AB2325.shtml.
The California Department of Public Health (CDPH) continues to investigate an outbreak of Burkholderia cepacia infections, previously reported in CHA News. According to CDPH, infections are linked to Medline Remedy® Essentials No-Rinse Foam, a product used for skin and perineal care. Medline has issued a voluntary recall of lots beginning with batch numbers M05703, M06691 and M07247. Health care facilities should follow the instructions for the recalled lots and consider avoiding other lots of the product while the investigation is being conducted. Facilities that use Medline Remedy® Essentials No-Rinse Foam and have at least one case of Burkholderia cepacia since Feb. 1, or that identify two or more cases of Burkholderia cepacia in non-cystic fibrosis patients since Feb. 1, should notify their local public health department and the CDPH Healthcare-Associated Infections Program at HAIprogram@cdph.ca.gov. More information is available in the attached update from CDPH.
The California Department of Public Health has released the attached All Facilities Letter 18-18 outlining the new online licensing and certification application process for certain facilities, including skilled-nursing facilities. The new online process should be used only for initial licensing approval; reports of changes and change of ownership applications must still be submitted by hard copy. More details, including instructions for registering and submitting an application, are available in the attached letter.
The Office of Statewide Health Planning and Development has released quality ratings for the 126 California-licensed hospitals that performed isolated heart bypass graft surgeries in 2015. Coronary artery disease is the leading cause of adult non-maternal admissions to California hospitals, representing nearly 9 percent of admissions. The surgery is the most common surgical procedure for treating coronary artery disease and is one of the most expensive cardiac surgeries performed in California. Hospital performance ratings are based on operative mortality, post-operative stroke and unplanned hospital readmission within 30 days; all measures are risk-adjusted. Because the surgery relies on using a vein or artery from another part of the body to create a new path for blood to flow to the heart, bypassing the blocked artery, hospitals are also rated on their utilization rates for the internal mammary artery.
A new state law requires health care providers diagnosing or treating Parkinson’s disease patients to report each case to the California Department of Public Health (CDPH) beginning July 1. The state is establishing the California Parkinson’s Disease Registry, a statewide population-based registry that will measure the incidence and prevalence of Parkinson’s disease. CDPH intends to use the information to improve the lives of those affected by the disease.
CDPH recently issued an implementation guide that includes the necessary specifications for reporting Parkinson’s disease data and outlines who is required to report, the timing of reporting and the methods for transmitting data. CHA is seeking clarification on some of the elements in the implementation guide and will share more information with members when available. CDPH will host informational meetings in May. For more information, visit the CDPH website.
Yesterday, two bills sponsored by CHA successfully passed the Assembly Health Committee.
Assembly Bill 1795 (Gipson, D-Carson), CHA’s co-sponsored bill with Los Angeles County, passed on a 12-0 vote. The bill would authorize a local emergency medical services agency to allow specially trained paramedics to transport patients who meet specific criteria to a locally designated behavioral health treatment facility or sobering center, allowing for more direct access to appropriate care and increased efficiency for local emergency response systems. The California Office of Statewide Health Planning and Development has supported a paramedic alternate destination pilot project since 2015. At the hearing, representatives from several pilot sites — Kevin Mackey, MD, medical director, Sacramento Regional Fire Department; Clayton Kazan, MD, medical director, Los Angeles County Fire Department; and Shannon Smith-Bernardin, PhD, RN, CNL, director of clinical services, Los Angeles County Department of Health Services, Housing for Health — testified about the results of their work. CHA thanks the members and partners who participated in a special lobby day on April 4, as well as those who responded to CHA’s Advocacy Alert.
Assembly Bill 2798 (Maienschein, R-San Diego), which would establish time frames for the California Department of Public Health (CDPH) to process hospital applications for new or modified services, unanimously passed the Assembly Health Committee on a 15-0 vote. If CDPH does not meet its time frames, the bill would allow hospital applications for expanding existing services — in compliance with existing requirements for that service — to be considered approved and licensed for 18 months, allowing CDPH to complete its review.
The California Department of Public Health has issued the attached All Facilities Letter 18-14 to explain the requirements of a new law that allows the Medical Board of California to impose fines of $50,000-$100,000 on individuals at health facilities if they fail to file a Health Facility/Peer Review Reporting Form. The new law, effective Jan. 1, applies to administrators of peer review bodies, health facility chief executive officers or administrators, and others required to file the form. The law does not change the requirement to submit the report within 15 days after making a final decision or recommendation to take disciplinary action, regardless of whether a hearing is held.
The AFL explains circumstances that require reporting, who is responsible for reporting and which disciplinary actions must be reported.
The California Department of Public Health has issued the attached All Facilities Letter 18-13 clarifying the scope of practice for pharmacy technicians and intern pharmacists. Senate Bill 1039 (Chapter 319, Statutes of 2014), which took effect Jan. 1, 2015, expanded the scope of practice for professionals. The letter states that facilities do not need to request program flexibility to allow pharmacy technicians and intern pharmacists to operate within their scope of practice and outlines the various duties each is authorized to perform.
The California Department of Public Health has released the attached All Facilities Letter 18-05.1, clarifying the process for referring low and medium non-immediate jeopardy entity-reported incidents (ERIs) to accrediting organizations. The department advises hospitals to continue reporting ERIs to their district office for triage and prioritization. If the district office determines that the ERI is eligible for referral to an accrediting organization, it will inform the entity that it may contact the applicable accrediting organization for further action. This letter supersedes All Facilities Letter 17.11.
This week, the California Department of Public Health (CDPH) released its 2018 Fee Report, which proposes to increase hospital fees by 5 percent (from $515.04 to $540.79 per licensed bed) and add a supplemental facility fee of $50.53 per bed for hospitals in Los Angeles County.
Historically, the department has contracted with Los Angeles County to use county employees, rather than state workers, to perform facility licensing and certification duties for facilities in that area. The budget proposal asserts that the cost of doing business is higher there than in other parts of the state, and that licensing fees are commensurate with Los Angeles County’s costs to complete the workload. This increase coincides with a proposal to extend the current Los Angeles County contract for one year, and then negotiate a three-year contract beginning in July 2019. The proposal includes a “pay-for-performance” program.
CHA is analyzing the proposal, but generally supports using performance metrics for improvement across the entire state, rather than in only one jurisdiction.
The California Department of Public Health has released the attached All Facilities Letter 18-11, clarifying a new law that increases — from a maximum of $20,000 to a maximum of $75,000 — the fine for a health facility that discriminates or retaliates against a patient, employee or other health care worker for presenting a complaint against or cooperating in an investigation of the facility. This letter supersedes All Facilities Letter 17-28 and clarifies that the new law does not apply to long-term health care facilities.
The California Department of Public Health has released the attached All Facilities Letter 18-07, informing health care facilities that Assembly Bill 1456 (Chapter 151, Statutes of 2017) extends the maximum duration of waivers issued to unlicensed psychologists gaining qualifying experience toward their license from three to four years. The law, which took effect July 31, 2017, makes no changes to waiver eligibility requirements. Questions about requesting a waiver should be directed to the department’s State Facilities Section at (855) 804-4205 or firstname.lastname@example.org.
The Medical Board of California has released guidelines for providers recommending cannabis for medical purposes. The guidelines emphasize the importance of collaboration between physicians and their patients, noting that — prior to authorizing or recommending cannabis — physicians should document an established physician-patient relationship with mutual understanding of shared responsibility for the patient’s care. The board also recommends that physicians document a medical examination of the patient, including the patient’s history of present illness, social history, past medical and surgical history, alcohol and substance use history, and diagnosis requiring the cannabis recommendation.
Importantly, the guidance notes that Business & Professions Code Section 2525.3 states that recommending cannabis to a patient without appropriate examination and medical indication constitutes misconduct. The guidance goes on to detail treatment agreements, outlines qualifying conditions, and provides information on monitoring and adapting the treatment plan. The board’s guidance is not intended to mandate the standard of care.