Effective January 2017, hospitals that perform sterile compounding must meet new regulatory requirements from the California State Board of Pharmacy. Beyond updating processes and procedures, hospitals will be required to improve or reconfigure facilities for ventilation, install new equipment for sterility and ensure employee protections.
The California Department of Public Health Center for Health Care Quality has released quarterly performance metrics on long-term care facilities and — for the first time — non-long-term care facilities, including general acute hospitals. The reports provide data through Sept. 30, 2016, on facility complaints, entity-reported incidents and relicensure surveys.
The California Department of Public Health (CDPH) is now accepting applications for state funding to assist with implementing the Regional Perinatal Programs of California (RPPC). Under CDPH’s direction, grant recipients will develop and maintain a network of providers and facilities within specific geographic areas and match the needs of high-risk perinatal patients with the appropriate type and level of care. Applications will be accepted through March 23; eligible entities include public or private nonprofit health agencies, hospitals, nonprofit community-based organizations and community clinics classified as 501 (c)(3) tax exempt. Total funding for the program is estimated to be $3.9 million for two years, and will be allocated from the state general fund. For more information and to apply, visit the CDPH website.
The Centers for Medicare & Medicaid Services (CMS) has posted frequently asked questions about the Medicare Outpatient Observation Notice (MOON), which went into effect March 8. The FAQs provide more information about how to complete the MOON’s “free text field,” which is intended to address the reason patients are in outpatient observation care rather than inpatient care. The FAQs also address alternate languages, modifying the form, and whether the form should be provided to Medicare Advantage enrollees.
As a reminder, CMS requires hospitals, acute psychiatric hospitals and critical access hospitals to provide all Medicare-eligible patients who receive outpatient observation services for more than 24 hours with a written MOON and oral notification. In addition, as of Jan. 1, state law requires hospitals to provide a written notice to a patient on observation status who is cared for in a hospital’s inpatient unit or in an observation unit, or following a change in a patient’s status from inpatient to observation. The notification must be provided as soon as practicable. A CHA webinar on the notification requirements of state and federal law is available at www.calhospital.org/observation-services-webinar-recording.
As of Jan. 1, SB 1076 requires hospitals to provide a written notice to certain patients receiving observation services. Beginning March 8, CMS will require hospitals to provide the Medicare Outpatient Observation Notice (MOON) and verbal notification to Medicare beneficiaries receiving outpatient observation services.
The California Department of Public Health has released the attached All Facilities Letter reminding facilities not to use a new facility name until the Centralized Applications Unit (CAU) completes all related approvals. State law requires a facility to submit a new licensing application for any change of ownership. If a facility is requesting a name change when submitting the change of ownership application, the facility may not use the new name until CAU has approved it, Licensing and Certification has conducted the survey, and CAU has issued the license.
CDPH has updated its previous All Facilities Letter (AFL) clarifying the process by which hospitals may apply for an observation services unit, and addressing notification of patients receiving observation services. SB 1076 (Chapter 723, Statutes of 2016), which took effect Jan. 1, requires hospitals to provide a written notice to a patient on observation status who is cared for in a hospital’s inpatient unit or in an observation unit, or following a change in a patient’s status from inpatient to observation.
The law requires the notice to state that while on observation status, the patient’s care is being provided on an outpatient basis, which may affect his or her health care coverage reimbursement. In addition to the notification requirement, SB 1076 allows for the designation and use of observation units for the first time. Many hospitals have developed clinical decision units or emergency department-adjacent units to care for patients on observation status; this was not specifically permitted by state law until now.
As previously reported in CHA News, a significant number of registered nurses (RNs) do not have complete fingerprints on file with the Board of Registered Nursing (BRN). Last December, the BRN notified these RNs that their information was incomplete, but many did not respond, according to the BRN. A second notice was sent Jan. 30, with a deadline of Feb. 8. CHA urges RNs to review their fingerprint requirements, particularly the section on determining whether to submit new fingerprints. Failure to submit fingerprints by the Feb. 8 deadline could result in a citation and fine of up to $2,500, or referral to the Attorney General’s office for possible disciplinary action.
A new multisociety guideline published in Gastrointestinal Endoscopy has updated information on critical reprocessing steps for certain endoscope models, including those with movable elevators at the distal tips such as duodenoscopes and linear U.S. endoscopes. Based on 2011 guidelines, the update offers expanded details and more information on issues for which incomplete data exists to guide practice. Health care providers are encouraged to visit www.giejournal.org to obtain the article, available in 2017 volume 85, issue 2. In light of the updated guidelines, providers should review their current endoscopic reprocessing policies.
The California Department of Public Health has released the attached All-Facilities Letter outlining compliance requirements for licensed primary care clinics (PCCs) under AB 2053 (Chapter 639, Statutes of 2016), which took effect Jan. 1. AB 2053 established consolidated licensure for PCCs, allowing eligible clinics to add additional physical plants to their current license maintained and operated on separate premises. A PCC or affiliate clinic may add additional locations that are no more than one-half mile from the licensed clinic adding the additional physical plant. A licensing fee is required for each additional physical plant approved on the license. For more information, see the attached letter.
On Nov. 18, the Centers for Medicare & Medicaid Services (CMS) released a memorandum providing an update on its three-year pilot to improve assessment of infection control and prevention regulations in hospitals and long-term care facilities, as well as during transitions of care. Now in its second year, the pilot seeks to identify new surveyor infection control tools and develop survey processes that can be used to optimize future assessment of new and proposed infection control regulations.
In 2017, CMS will select 40 hospitals nationwide to receive a draft survey, using updated surveyor infection control worksheets that are based on the new long-term care regulation. CMS does not indicate how it will choose hospitals for participation in the pilot. Surveys will be conducted by contractors, who should have appropriate credentials and proper identification. No citations will be issued unless an immediate jeopardy deficiency is identified, which would then be reported to the California Department of Public Health. Surveys are intended to educate hospitals and pilot the survey tools, which address areas not included in the existing CMS survey process, including drug diversion, water quality outbreaks and infection prevention during transitions of care. The worksheets to be used for the pilot survey are attached to CMS’ memo.
The Board of Registered Nursing (BRN) has determined that certain registered nurses do not have both Department of Justice (DOJ) and Federal Bureau of Investigation (FBI) fingerprint results on file with the BRN. LiveScan testing incorporates both DOJ and FBI requirements; however, if the LiveScan technology did not produce clear results or an outdated method of fingerprinting was used, the RN may not have acceptable fingerprints on file.
The BRN is working to contact all affected RNs via mail and/or email with instructions. To avoid potential delays in license renewal or other action, RNs should read the information carefully and respond accordingly. In most cases, RNs will be required to submit fingerprints within 60 days of notification or risk citation, fines or referral to the Attorney General’s office for possible disciplinary action.
Senate Finance Committee Chairman Orrin Hatch (R-Utah) and Ranking Member Ron Wyden (D-Ore.) this week issued a report detailing the practices of concurrent and overlapping surgeries where lead doctors at teaching hospitals perform multiple surgeries at the same time. The report, titled “Concurrent and Overlapping Surgeries: Additional Measures Warranted,” outlines a number of shortfalls at the federal level in monitoring and auditing teaching hospitals to ensure they comply with Medicare billing restrictions. It also makes a number of recommendations for hospitals and regulators to ensure patient safety and improve transparency. The report’s findings stem from a letter the committee sent 20 teaching hospitals in February, questioning them about these practices in their institutions. Report findings include:
The Centers for Medicare & Medicaid Services (CMS) has posted its updated version of the Medicare Outpatient Observation Notice (MOON), a standard notice that all hospitals and critical access hospitals must provide to Medicare beneficiaries who receive outpatient observation services for more than 24 hours. The federal Notice of Observation Treatment and Implication for Care Eligibility Act requires that hospitals provide oral and written notice to beneficiaries within 36 hours after observation services are initiated, or sooner if the individual is transferred, discharged or admitted as an inpatient. The notice informs patients that they are an outpatient receiving observation services, not an inpatient, and outlines the associated implications for cost-sharing and eligibility for Medicare coverage of skilled-nursing facility services.
Medicare administrative contractor Noridian has updated its website with important information about patient order authentication requirements. With input from CHA, the site now reflects the current medical records condition of participation, which allows physician authentication orders to be signed by another practitioner who has responsibility for a patient, rather than only by the ordering physician.
Noridian previously published a response in one of its FAQ documents stating, “Orders may be accepted and put in writing by personnel authorized to do so by applicable State and Federal laws and regulations. The order must be countersigned and dated by the ordering physician within an acceptable timeframe.”
The statement now correctly reiterates, “All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.”
The Centers for Disease Control and Prevention (CDC) has released guidance for improving antibiotic prescribing in outpatient settings, focusing on commitment, action for policy and practice, tracking and reporting, and education and expertise. The guidance supplements previously released guidance and is intended for clinicians in primary care, outpatient specialty and subspecialty clinics, as well as emergency departments, nurse practitioners, physician assistants and health care systems. The CDC recommends implementing at least one policy aimed at improving antibiotic prescribing and encourages clinicians to educate patients on appropriate antibiotic use.
The California Public Protection and Physician Health, Inc. (CPPPH), in collaboration with several other stakeholder groups, is seeking review and comment on recently published draft guidelines for medical staff and groups. Titled Behaviors that Undermine a Culture of Safety — Policies and Procedures for Medical Staffs and Medical Groups, the guidelines are intended to assist in identifying policies and procedures that support professional behavior, as well as maintaining a culture of safety and professionalism within medical staff and the medical centers. CPPPH asks that those interested in reviewing the document send their comments by Dec. 5 to email@example.com.
Last month, the National Quality Forum (NQF) launched the Medicaid Innovation Accelerator Project, which will identify and recommend a set of Medicaid-relevant performance measures, measure concepts, or measures under development to the Medicaid Innovation Accelerator Program (IAP). The IAP targets four main program areas: reducing substance use disorders; improving care for Medicaid beneficiaries with complex care needs and high costs; promoting community integration for beneficiaries using long-term services and supports; and integration of physical and mental health.
The Centers for Disease Control and Prevention (CDC) today announced that Stӧckert 3T Heater-Cooler devices manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) may have been contaminated with Mycobacterium chimaera (M. chimaera) in the manufacturing process, and that patients for whom these devices were used during cardiac surgery may be at risk of developing infections. As reported previously in CHA News, M. chimaerahas been the subject of an ongoing investigation by the California Department of Public Health.
CDC advises providers to alert patients who have had open heart surgery involving one of these devices, and has released a toolkit to assist hospitals in their outreach, including a sample notification letter, a letter for clinicians and a questions-and-answers document. Also today, the Food and Drug Administration issued a Safety Communication providing further recommendations for providers.
The California State Board of Pharmacy has finalized regulations governing the preparation of compounded drugs by pharmacies, culminating a major effort to strengthen the oversight and enforcement of pharmacies that produce or ship compounded drug products. The new regulations have been approved by the Office of Administrative Law and will take effect on Jan. 1, 2017.
The comprehensive changes to regulations cover a broad range of topics related to general drug compounding, including requirements for recordkeeping, labeling, policies and procedures, maintaining facilities and equipment, staff training and quality assurance. The regulations have also been amended to expand sterile compounding requirements to drug products that are produced for administration by inhalation or into the eye as well as by injection. CHA’s sterile compounding web page includes several tools that hospitals might find helpful in planning to comply with the new regulations. The full text of the final requirements is available on the Board of Pharmacy website.