In this issue:
Number of fungal meningitis cases continues to rise nationwide
Minnesota hospitals have been vigilant about responding to the nationwide outbreak of fungal meningitis and ensuring patients at risk of infection are notified. As the number of cases in Minnesota continues to rise, we thought it would be helpful to reiterate the recommendations from the U.S. Food and Drug Administration (FDA). For the latest information, visit the FDA website.
- On Oct. 4, 2012, FDA advised medical professionals that all products produced by New England Compounding Center (NECC) should be retained, secured, and withheld from use. FDA is advising medical professionals not to use ANY products from NECC.
- A complete list of all NECC products subject to this recall can be accessed here [HTML | PDF]. The FDA made a point to say, however, that they cannot be certain this list is accurate.
- On Oct. 15, 2012, FDA further advised health care providers to follow-up with patients who were administered any NECC injectable product on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.
- FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditions are met:
- Since the May 21, 2012 date is the date the first of three lots of methylprednisolone acetate implicated in the current outbreak was produced, products produced and shipped by NECC on or after May 21, 2012 are believed at this time to be of greatest risk of contamination.
- The medication was administered to patients on or after May 21, 2012.
- The medication was shipped by NECC on or after May 21, 2012, and
- The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution,
- The FDA issued two lists of NECC customers. The first list includes customer names and addresses, organized by state. The second list is organized alphabetically by customer name and includes the specific products shipped, the quantities of product shipped, and the shipping date. Despite making corrections and reissuing the list, the FDA still says it cannot vouch for the completeness or accuracy of the lists so hospitals should verify their own records.
We know you have already been notifying patients and setting up hotlines, and here are resources from the CDC and FDA:
- The Centers for Disease Control and Prevention has posted information for patients and consumers about what to do. In addition, the Minnesota Department of Health is receiving guidance from the CDC, and MDH has set up a web page where you can subscribe to updates about the fungal meningitis outbreak in Minnesota.
- The FDA website has a Patient Notification Letter. This letter template is for health care professionals notifying patients administered a drug produced by NECC that has been recalled.
For hospital pharmacists and patient safety contacts:
- MHA’s patient safety team is developing a checklist and/or recommendations for process improvement when it comes to purchasing medications.
- In the meantime, it is good practice for hospitals to have in place a due diligence process when contracting with compounding pharmacies to ensure they are getting good, quality and safe products. Some of the steps hospitals can take include: checking the facility’s license and certificates of insurance; checking that the facility staff are licensed by federal and local agencies; and obtaining from the facility information about product problems or recalls, including state board of pharmacy investigations or enforcement actions and/or FDA warning letters and enforcement actions.
- The Minnesota Board of Pharmacy’s website allows you to verify the licensure/registration status of pharmacists, interns, technicians, pharmacies, drug wholesalers, drug manufacturers, and medical gas distributors. We recommend verifying what their license allows them to do. This service is available to anyone.
In order to help us better gauge this issue internally, it would be helpful if you could let us know if you received products from NECC and if so, how many patients you are contacting. Please send your information to Wendy Burt, MHA vice president of public relations and communications. Let us know if there is anything else we can help you do to address this issue.^top of page
MnSCU assesses future health care workforce needs
Minnesota State Colleges and Universities (MnSCU), in partnership with the Minnesota Chamber of Commerce and the Department of Employment and Economic Development, released a summary outlining their findings from nine health care workforce listening sessions held in April and May.
The listening sessions were intended to engage employers on developing projections for how many workers will be needed, for what kind of jobs, with what kinds of skills. MnSCU plans to use the information gathered at these listening sessions to align their programs with the needs of Minnesota’s business, industries and communities. Highlights include:
- Financial cuts are a prominent workforce challenge in health care, causing people to do “more with less” and positions to go unfilled because of financial challenges.
- Rapidly changing technology has created the need for increased IT skills among health care workers.
- The roles of health care professionals are changing; nurses will be asked to work to the “top of their degree” and to take on new roles as health care moves from an acute care model to a community care model.
- With an aging population, there is a greater demand for geriatric, palliative and hospice care.
The complete summary, along with regional data gathered before the meetings as a starting point for discussion, can be found here.
The health care listening sessions were held in Bemidji, Bloomington, Duluth, Fergus Falls, Mankato, Marshall, Rochester, St. Cloud and Winona. In total, MnSCU held 44 listening sessions in six industry sectors across the state.^top of page
MHA urges CMS to adopt expert panel's recommendations on physical supervision
MHA continues to challenge agency’s direct supervision policy
The Minnesota Hospital Association (MHA) submitted comments to the Centers for Medicare and Medicaid Services (CMS) challenging its preliminary decision regarding physician supervision for outpatient therapeutic services delivered in a hospital. MHA’s letter pointed to the negative impacts the policy interpretation will have for rural communities that will struggle to find the workforce necessary to meet the requirements, the unnecessary costs of complying with the agency’s approach, and the conflict between the direct supervision policy and long-standing conditions of participation for critical access hospitals.
Lawrence Massa, president and CEO of MHA, said that the Association hopes that Congress will step in with clarifying legislation to resolve what has become an ongoing dispute between the hospital community and CMS.
CMS’ policy interpretation for direct supervision for outpatient therapeutic services requires that a physician or non-physician practitioner be immediately available to address the patient’s need without any interval of time and he/she cannot be engaged in other patient care or activities.
In part because of challenges from MHA and the American Hospital Association, the agency appointed a panel of experts to recommend exceptions to this standard for certain outpatient services. The panel recommended that CMS change the requirement from direct to general supervision for 28 services. The agency agreed with the recommendations with respect to 15 of these services, but preliminarily rejected the experts’ advice for 13 services, including observation services. MHA’s comments urged CMS to follow the recommendations of its own experts.
For more information about the physician supervision policy or MHA’s comment letter, contact Matt Anderson, MHA vice president of regulatory and strategic affairs, 651-659-1421.^top of page
2012-13 Rural Hospital Grant Program application cycle begins
The Minnesota Department of Health Office of Rural Health and Primary Care awards grants to eligible hospitals under the Rural Hospital Capital Improvement Grant Program. The program helps small hospitals undertake needed modernization projects to update, remodel or replace aging hospital facilities and equipment necessary to maintain the operations of the hospital.
Eligible hospitals are non-federal, not-for-profit, general acute care hospitals with 50 or fewer beds located in a rural area or in a community with a population of less than 15,000 and outside the seven-county metropolitan area. Applicants may apply for grants of up to $125,000 and approximately $1.7 million is available. Pre-applications are due Dec. 17 and are available on the Office of Rural Health & Primary Care website. Final applications are due March 18, 2013.
For information and assistance, contact Will Wilson, Minnesota Department of Health, Office of Rural Health and Primary Care, 651-201-3842.^top of page|
Response needed on hospital community benefit survey
Survey deadline is Friday, Nov. 2
Please ensure that your hospital has completed the community benefit survey. The deadline for submitting the activities your hospital provides its community through outreach and wellness programs and economic promotion and support is Friday, Nov. 2. This data is used in the annual Community Benefit Report and helps inform legislators and other key stakeholders about the important work hospitals do beyond providing high quality care.
Your participation is critical to ensure the report accurately reflects regional and statewide trends, and that all the beneficial activities hospitals provide to improve health and to provide access to care are acknowledged. If your hospital did not receive emails regarding the survey (sent out early October), please contact Bonnie Terveer, MHA data operations assistant, 651-603-3520.
Please note that we are also requesting your hospital’s Form 990 be sent to Bonnie Terveer.^top of page
MHA honored for making significant contributions to patient safety
The Minnesota Hospital Association (MHA) received the 2012 Minnesota Alliance for Patient Safety (MAPS) Award for its significant and lasting contributions to improving patient safety, specifically helping spread patient safety best practices throughout the state.
The awards recognize innovative patient safety efforts in three categories that support MAPS’ goals to provide care that is:
- Safe from avoidable harm;
- Coordinated across transitions;
- Provided in an environment where patients are knowledgeable and active participants in their care; and
- Delivered in a transparent and safe culture.
Lakeview Hospital in Stillwater was also recognized for its efforts to engage patients and their families and Children’s Hospitals and Clinics of Minnesota stood out for their process or system improvements that made the environment of care safer. The organizations were honored in front of nearly 400 hospital representatives, health care practitioners and patient advocates during the alliance’s biennial conference Oct. 26. ^top of page