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.
The Centers for Medicare & Medicaid Services (CMS) issued the attached survey and certification memo in May, clarifying requirements for providing services to justice-involved individuals in skilled-nursing facilities, nursing facilities, hospitals, psychiatric hospitals, critical access hospitals and intermediate care facilities for individuals with intellectual disabilities. CHA has reviewed the memo and is seeking information on how these changes might affect member organizations, as well as non-compliance citations that might be issued. More information, when available, will be shared with members through CHA News.
In response to the 2012 New England Compounding Center tragedy — where contaminated injections led to 64 deaths and hundreds of illnesses nationwide — federal and state laws have been reexamined to provide increased oversight and better safeguards for compounded pharmaceuticals. To meet the new federal and state requirements, CHA urges hospital leaders and pharmacists in charge (PICs) to review the new regulations immediately, perform a gap analysis and develop a plan to meet federal and state requirements.
The California Department of Public Health — in consultation with the California Conference of Local Health Officers — has updated the list of diseases that health care professionals and laboratories must report to their local health departments within a specified time frame, as required by the California Code of Regulations Title 17, Division 1, Chapter 4, Subchapter 1, Article 1, Section 2500 (reporting from providers to local health departments) and Section 2505 (reporting from laboratories to local health departments). The changes, effective May 24, are summarized below.
On May 13, the Centers for Disease Control and Prevention (CDC) issued interim guidance that recommends diagnosing Zika virus via real-time reverse transcription–polymerase chain reaction, a highly specific method that can be performed rapidly. Based on new data, CDC recommends testing urine collected less than 14 days after symptom onset, along with patient-matched serum samples collected less than seven days after symptom onset. CDC will continue to review and update guidance for Zika virus testing as new data becomes available.
The Clinical Infectious Disease journal has published guidelines for implementing an antibiotic stewardship program, authored by the Infectious Disease Association of America and the Society for Healthcare Epidemiology of America. Developed by a multidisciplinary expert panel including clinicians and investigators representing internal medicine, emergency medicine, microbiology, critical care, surgery, epidemiology, pharmacy, and adult and pediatric infectious diseases specialties, the guidelines address the best approaches for antibiotic stewardship programs to influence the optimal use of antibiotics.
The U.S. Food and Drug Administration (FDA) last week issued an emergency use authorization for a Zika virus diagnostic tool that will be distributed to qualified laboratories. The Centers for Disease Control and Prevention (CDC) will begin distributing the test during the next two weeks to qualified laboratories in the Laboratory Response Network; the test will not be available in U.S. hospitals or other primary care settings. The tool — Trioplex Real-time RT-PCR Assay — allows doctors to tell if an individual is currently infected with chikungunya, dengue, or Zika using one test, instead of having to perform three separate tests to determine which infection a patient might have. More information is available on the CDC website.
The Center for Disease Control and Prevention (CDC) this week issued guidance recommending standard health care precautions – including the use of personal protective equipment (PPE) – in all health care settings to prevent potential spreading of Zika virus. The guidance notes the precautions should be in place at all times, regardless of whether infection has been confirmed, because individuals infected with the virus are often asymptomatic. The guidance also details standard precautions and other prevention strategies specific to labor and delivery settings. Based on the premise that all body fluids might contain transmissible infectious agents, the standard precautions include hand hygiene, use of PPE, respiratory hygiene and cough etiquette, safe injection practices and safe handling of potentially contaminated equipment or surfaces. Additionally, CDC directs health care providers to use soap and water or alcohol-based products before and after a patient contact and after removing PPE, including gloves.
The Centers for Medicare & Medicaid services will host a Dec. 14 webinar on the Hospital Value-Based Purchasing (VBP) program, addressing surgical site infection rates for colon surgeries and abdominal hysterectomies within the Hospital VBP program. The webinar will include health care-associated infection standard population updates from the Centers for Disease Control & Prevention and methods to improve surgical site infection standardized infection ratios. Webinar slides will be available for download from www.qualityreportingcenter.com under “Upcoming Events” the day before the presentation. Registration is available online.
The California Department of Public Health’s (CDPH) Healthcare Associated Infection (HAI) program has implemented a voluntary surgical site infection (SSI) validation program. The program aims to help hospitals better assess the quality and accuracy of their SSI data.
All hospitals are eligible to participate; CDPH will identify hospitals as participating or non-participating in the next HAI report, published in the fall of 2016. When the report is published, CDPH will request a site visit at each hospital that did not participate in validation, as well as at each hospital in need of surveillance and reporting assistance, as indicated by the validation findings. The deadline to sign up and submit validation reports is Dec. 4. For information about the 2015 SSI validation process, visit www.cdph.ca.gov/programs/hai/Pages/2015SSIvalidation.aspx. For questions, contact HAIProgram@cdph.ca.gov.
Gov. Brown has signed into law AB 679 (Allen, Chapter 778, Statutes of 2015), extending the deadline for registering with the Controlled Substance Utilization Review and Evaluation System (CURES). Previous law required that all pharmacists and health care practitioners who are authorized to prescribe, order, administer, furnish or dispense Schedule II, III or IV controlled substances register with CURES by Jan. 1, 2016. Practitioners now have until July 1, 2016 to register. More information is available on the California Prescription Drug Monitoring Program website.
California Public Protection & Physician Health, Inc. (CPPPH), in collaboration with the UC San Diego Physician Assessment and Clinical Education (PACE) program, has announced its 2015 project on evaluations of physicians. The project includes a workshop that will be offered in both northern California (Nov. 21) and southern California (Dec. 5), as well as a certificate of completion for those who prepare evaluations and wish to show that they have completed all steps of the CPPPH project. CHA is a joint founder of CPPPH, along with the California Medical Association, the California Society of Addiction Medicine and the California Psychiatric Association. The organization was founded to address the need for focused education, technical advice and consultation for medical staff and medical groups in support of physician health activities. For more information on the workshops and CPPPH, see the attached brochure.
The Food and Drug Administration (FDA) has notified providers that it has resolved technical problems with the Clozapine Risk Evaluation and Mitigation Strategy Program, and that prescribers and pharmacies should now be able to complete their online certification for the program. Clozapine is a medication for schizophrenia, and last month the FDA issued new monitoring, prescribing, dispensing and receiving requirements, attempting to address concerns about a serious blood condition called neutropenia that is sometimes associated with the medication. If prescribers or pharmacists encounter additional problems with the program, they should contact the FDA at (844) 267-8678.
An HVAC task force, whose members include the American Hospital Association’s American Society for Healthcare Engineering (ASHE), has issued the attached interim guidance to help health care facilities maintain appropriate temperature and humidity control in operating rooms and sterile processing departments while it works to achieve consensus on conflicting standards. Among other actions, the task force said it plans to explain the conflicting standards to accreditors and state licensing agencies and ask them to work with health care organizations to establish a plan for resolving variance.
In addition to ASHE, task force members include the American Society of Heating, Refrigerating and Air-Conditioning Engineers; Association for the Advancement of Medical Instrumentation; Association for Professionals in Infection Control and Epidemiology; Association of periOperative Registered Nurses; and the Facility Guidelines Institute.
The Joint Commission yesterday released a Sentinel Event Alert examining the contributing factors to patient falls and offering suggested solutions health care organizations can implement to help reduce them. The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm or severe temporary harm where intervention is required to sustain life.
You’ve received a licensing violation. You may have been expecting it from a recent survey, or it may have come as a complete surprise. One thing is for certain, survey activity — and subsequent violations — will be more common now that California Department of Public Health (CDPH) has issued new regulations for hospital penalties, including non-immediate jeopardy violations.
The CHA Joint Committee on Accreditation & Licensing is currently accepting new member applications. The committee, which meets quarterly in Sacramento, addresses hospital accreditation, regulatory and licensing issues and makes policy recommendations to the CHA Board of Trustees. To be eligible to serve on the committee, individuals must be employed with a CHA member hospital and serve as liaison for accreditation and licensing issues at their facility. To apply, send a biography to Lori Woolsey at email@example.com by April 4.