NTCA has learned that the FDA has removed APLISOL® from its current shortage listing. APLISOL® is now listed on the CBER-Regulated Products: Resolved Shortages webpage.

In response to a call from NTCA, the manufacturer of APLISOL®, Par Pharmaceutical Companies Inc., stated that all geographic markets/wholesalers throughout the US should have adequate inventory now. In another call, Sanofi confirmed that Tubersol® is still in allocation.

The Missouri Department of Health and Senior Services (DHSS) has investigated over 100 cases of Legionnaires’ disease, a serious lung infection, across Missouri so far this year; five of those who have contracted the disease are reported to have died. Although most people exposed do not develop illness, approximately 10-25 percent of Legionnaires’ disease cases are fatal. Reports of Legionnaires’ disease are increasing in Missouri and nationally. In response, DHSS has strengthened Legionnaires’ disease detection and prevention efforts.

Recently, DHSS filed emergency rules to reduce the timeframe for reporting legionellosis from three days to one day and introduced new testing methods at the Missouri State Public Health Laboratory (MSPHL).

“The timely diagnosis of legionellosis, and the identification of the water sources from which it arises, is crucial for preventing morbidity and mortality in the larger community,” said Dr. Randall Williams, director of DHSS. “We are committed to raising awareness and continuing to work with local health departments and the CDC during outbreaks, and we are excited about the innovative testing that MSPHL has instituted to aid in timely detection of Legionella in water sources.”

The MSPHL’s Environmental Bacteriology Unit can test water samples for the presence of Legionella pneumophila using the Idexx Legiolert system. The Legiolert test method provides highly sensitive results in just seven days that can also be used for further comparison to patient samples to link individual cases with environmental sources. 89 samples have been tested at the MSPHL for Legionella pneumophila since June 19.

“The MSPHL now provides high-quality testing services to detect Legionella pneumophila in a timely manner,” said Bill Whitmar, director, MSPHL. “This service not only protects our communities but also those who visit our communities.”

DHSS and local public health partners have completed over 50 environmental assessments this year at lodging and health care facilities in Missouri. DHSS has also been working to educate management of these types of facilities on the disease and what proactive measures can be taken to prevent anyone from contracting the disease from their water systems.

Legionella can be found naturally in the environment, but generally is not present in sufficient numbers to cause disease. In human-made water systems, like the interior plumbing of large buildings, cooling towers, decorative fountains, or hot tubs, Legionella can grow and be transmitted to susceptible people by breathing in small water droplets containing the bacteria. People at higher risk for getting sick include those over age 50, former or current smokers or those with chronic lung diseases, cancer, or other underlying illnesses. It is not spread from person to person.

While public health efforts are focused on investigating cases associated with lodging and health care facilities, you can take steps to protect yourself at home. Improper CPAP machine use (commonly used to treat sleep-related breathing disorders) is a frequently reported risk factor. You can reduce your risk of exposure by proper maintenance of CPAP machines, humidifiers and other household equipment where bacteria may grow that may create water vapor.

Outbreaks of Legionnaires’ disease often occur in hotels, health care facilities and pools. Although over 800 cases have been reported in the state since 2014, this disease is not a concern isolated only to Missouri. Earlier this month, a hotel in downtown Atlanta voluntarily closed after at least nine guests contracted the disease.

Please see the most frequently cited deficiencies report from the second quarter of 2019.

The Department of Social Services (DSS) wants to alert providers to a genetic testing scheme that is currently happening in many states, including Missouri. On June 3, 2019, the U.S. Department of Health and Human Services (DHHS) Office of Inspector General (OIG) issued an alert regarding scammers offering individuals cheek swabs for genetic testing to obtain their Medicare or Medicaid information for identify theft or fraudulent billing purposes. Fraudsters are targeting beneficiaries through door-to-door visits, booths at public events, health fairs, and telemarketing calls.

DSS has received reports that genetic testing marketers have been contacting Missouri residents throughout the state. They might put on some type of game like bingo with prizes or food to get residents to come to them. Sometimes announcements are made to all senior housing residents over a building intercom system. They typically try to determine if the individual has Medicare or Medicaid coverage. They may be dressed in scrubs or white coats to give the appearance they are a health care professional. In some cases, they may indicate they represent a medical research facility.

They typically have a short questionnaire and ask whether any of the individual’s relatives have had cancer or other diseases. They indicate a genetic test can be conducted to determine if the individuals already has a disease, or if they are susceptible to acquiring the condition. In some cases, they indicate the test will tell whether the combination of prescription and over the counter medications the individual is taking are having an undesired interactions or adverse effects on their metabolism.

If the individual agrees to be tested, the representative obtains their Medicare or Medicaid numbers and uses a swab to take a saliva sample from inside their mouth. The individual might be asked to sign the questionnaire. They are typically told the test results will be sent to them in several weeks, usually somewhere between four and eight weeks. The individuals might not receive the results of a lab test later.

MO HealthNet participants who have been solicited by a genetic testing marketer to provide a saliva sample using a cheek swab, or have already provided one, please report it to the Missouri Medicaid Audit & Compliance (MMAC) by email at MMAC.ReportFraud@dss.mo.gov or by phone to the MMAC Fraud Hotline at (573) 751-3285.

On June 6, 2019, the Missouri Department of Health and Senior Services (DHSS) distributed information from the Centers for Disease Control and Prevention (CDC) that provided patient care and public health recommendations in the context of the nationwide shortage of tuberculosis skin test (TST) antigens.

This information is available on the DHSS website, health.mo.gov/emergencies/ert/alertsadvisories/pdf/cdc-advisory6-6-19.pdf.

The following SLCR recommendations provide additional guidance for long-term care providers:
The Section for Long-Term Care Regulation (SLCR) recognizes that there may be some delay in obtaining the supplies needed to do the required TST testing and will allow the following:

• Make every effort to obtain the TST testing supplies including checking with your local health department, all suppliers, etc. in a timely manner.
• Document all attempts to obtain the TST testing supplies and estimated times of delivery.
• Until you can obtain the necessary TST testing supplies:
  • Establish a written plan for the TST shortage for testing of potential new employees and new residents within the same timeframes as required for the TST testing.
  • The plan must, at a minimum, include assessing new employees for signs and symptoms of TB prior to allowing direct contact with residents.
  • The plan must include assessing any new resident upon admission for signs and symptoms of TB.
  • Upon admission of residents, complete an evaluation to rule out signs and symptoms of TB and postpone the TST until supplies are available.
  • Document this assessment.
• During the shortage, if supplies are still available, new employees should be administered the one-step TST upon hire, and then defer the second step TST until the shortage resolves. If supplies are not available, conduct a symptom screen and document. Defer the two-step until the shortage resolves.
• Defer the annual testing of current employees, but if the annual comes due during this time, assess the current employee for signs and symptoms.

If the assessment of any employee or resident results in signs and symptoms of possible TB, instruct them to see their physician or their local public health department.

Once the TST testing supplies become available all employees or residents who required testing and were not tested, must be tested. SLCR expects the testing to be completed within a reasonable time period, usually within 30 days of obtaining the supplies.

TST testing is not an annual requirement for residents. Some homes have elected to do the TST instead of an annual review of symptoms. The only requirement for residents after the admission two-step TST is an annual review of symptoms to assure no signs of TB.

OR

You may follow the CDC guidance as noted below:
CDC recommends any of three general approaches for addressing the shortages of tuberculin skin test antigens:

• Substitute IGRA blood tests for TSTs. The costs associated with using the blood tests can be greater than the cost of TSTs. The blood tests require phlebotomy, preparation of blood specimens, and specific laboratory services for analysis. Thus, these tests are not available in all practice settings. Clinicians who use the IGRA blood tests should be aware that the criteria for test interpretation are different than the criteria for interpreting TSTs.
• Allocate TSTs to priority indications, such as TB contact investigations, as determined by public health authorities. This might require deferment of testing some persons. CDC does not recommend testing persons who are not at risk of TB.
• Substitute TUBERSOL® for APLISOL® for skin testing. In cross-sectional studies, the two products give similar results for most patients.

If you have any questions, please contact the Missouri Department of Health and Senior Services (DHSS) Bureau of Communicable Disease Control and Prevention at 573-751-6113.

The Section for Long-Term Care Regulation is again seeking input from long-term care providers. We are asking for your help in identifying areas in our Section where excellent customer service is provided and areas where we need to focus on improving our customer service experience. Please take a couple minutes to complete our 2019 Provider Feedback Survey at https://www.surveymonkey.com/r/RRR9NG9 by June 30, 2019.

The DMH PASRR Level II Assessment webpage is a resource to assist Nursing Facilities with the level II process and care planning for behavioral and mental health conditions. The web page includes an overview of the preadmission screening and resident review process, reporting requirements for NF, who to contact for assistance, how to file an appeal, where to find answers to FAQ and links to crisis planning and other resources.

Please visit the website at https://dmh.mo.gov/programs.html.

Please see the most frequently cited deficiencies report from the first quarter of 2019.

In response to feedback to the original draft Nursing Facility Level of Care algorithm, revisions have been made and a revised version, Version 2.0, has been developed. Please review the draft algorithm and accompanying documents and provide feedback as directed below. Your feedback is critical to this process.

In addition to the actual revised algorithm, a level of care determination guide has been developed to serve as a summary of the DRAFT LOC Algorithm 2.0. This guide serves as a blueprint for stakeholders and participants to understand proposed LOC updates. (The DRAFT LOC Algorithm 2.0 along with the InterRAI Home Care assessment tool is specific and should be used to determine a participant’s LOC.)

InterRAI Home Care – MO Version PW
DRAFT LOC 2.0 Algorithm
Nursing Facility Level of Care (LOC) Determination Guide 4-16-2019
Participant Worksheet

Please submit feedback until May 20, 2019, by emailing your participant worksheets, determination guides and comments to LOCTransformation@health.mo.gov.

The password for the InterRAI Home Care assessment tool and any questions regarding the revised algorithm may be sent to slcr@health.mo.gov.

Due to a continued increase in the volume of complaints received by the Adult Abuse and Neglect Hotline, long term care providers have had difficulty in reaching the hotline via telephone. A reminder that you may utilize the Mandated Reporter Form and fax it to CRU at 573-751-4386 at any time, in order to fulfill your requirement to report abuse and neglect.

There are numerous cases of Legionnaire’s disease reported in Missouri each year, and the frequency of those reports is increasing. The Section for Long-Term Care Regulation (SLCR) has had several resident cases of possible and confirmed legionella infections in long-term care facilities over the past couple of months. As a partner in protecting the health of the public, please read the letter from DHSS Director, Dr. Randall Williams.

CMS guidance
On June 02, 2017, CMS issued a memo titled Requirement to Reduce Legionella Risk in Healthcare Facility Water Systems to Prevent Cases and Outbreaks of Legionnaires’ Disease. www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-17-30.pdf

As part of the recertification survey process, SLCR surveyors are required to review and ask homes about their legionella risk assessment, water management programs, and testing. Specifically, surveyors will review policies, procedures, and reports documenting water management implementation results to verify that facilities:

• Conduct a facility risk assessment to identify where Legionella and other opportunistic waterborne pathogens could grow and spread in the facility water system.
• Implement a water management program that considers the ASHRAE industry standard and the CDC toolkit, and includes control measures such as physical controls, temperature management, disinfectant level control, visual inspections, and environmental testing for pathogens.
• Specify testing protocols and acceptable ranges for control measures, and document the results of testing and corrective actions taken when control limits are not maintained.
• Maintain compliance with other applicable Federal, State and local requirements.

Did you know?

• Although most people exposed do not develop illness, approximately 25 percent of Legionnaires’ disease reported healthcare-associate cases are fatal.
• The optimal growth temperature for Legionella bacteria is between 77 degrees and 108 degrees.  Facilities should make efforts to keep water storage and delivery vessels temperatures out of the optimal Legionella bacteria growth range.
• Examples of building water systems that might grow and spread Legionella include: hot tubs, hot water tanks and heaters, large plumbing systems, cooling towers, and decorative fountains.

Water Management Programs
Adhering to an appropriate water management plan is critical for the successful control of Legionella bacteria in a health care setting. Developing and maintaining a water management program is a multi-step process that must be tailored specific to the facility and should be reflective of what the facility is actively doing. Below are seven steps to building an effective Legionella water management program.

• Establish a water management program team
• Describe the building water systems using flow diagrams and a written description
• Identify areas where Legionella could grow and spread
• Decide where you need to apply control measures and how to monitor them
• Establish ways to intervene when control limits are not met
• Make sure the program is running as designed and is effective
• Document and communicate all activities

Source: www.cdc.gov/legionella/wmp/overview/wmp-fact-sheet.html.

The CDC’s website also provides a list of factors to consider when looking to hire a Legionella consultant: www.cdc.gov/legionella/wmp/consultant-considerations.html.

FREE Online Training
The Centers for Disease Control and Prevention recently launched a free online training program on Legionella water management programs called PreventLD. This training would be helpful for any staff member at a Long Term Care Facility who would be responsible for implementing a Water Management Plan. Details and the link to register are available here: www.cdc.gov/nceh/ehs/elearn/prevent-LD-training.html.

Getting ready to transfer or discharge a resident? Please use the tip sheets below to guide you through the requirements. Please contact the Ombudsman Program or your Long-Term Care Regional Office if you have questions.

Transfer Discharge Tip Sheet- Certified 2.27.19

Transfer Discharge Tip Sheet- State Licensed 2.27.19

Please see the most frequently cited deficiencies report from the fourth quarter of 2018.

SLCR is pleased to announce that online payments for licensure fees, certification fees, and adult day care licensure fees are now accepted! To access the online payments webpage, follow the link: health.mo.gov/about/online-payment.php.

Feel free to contact the Licensure and Certification Unit with any questions at LTCapplication@health.mo.gov or (573) 526-8508.

Top Deficiencies Report – 3^rd Quarter 2018

Please see the most frequently cited deficiencies report from the third quarter of 2018.