Keeping track of heath care regulations is a daunting task. However, INCompliance can help your organization plan and prepare for future demands for health care services. We offer practical options to identify your health service areas and address health needs in your community. Our areas of expertise include:
Community Health Needs Assessment (CHNA)
Health Care Planning
Long-Term Care and Assisted Living
All of our services consider the timing of each component to ensure your goals are met according to internal and external deadlines.
The 2010 Affordable Care Act requires that all 501(c)(3) hospitals conduct a community health needs assessment (CHNA) to maintain tax-exempt status. INCompliance provides the support you need to develop a CHNA report and implementation strategy that complies with this requirement. Specifically, we can help address the following frequently asked questions.
The IRS rules allow some flexibility. In most cases, it should be defined geographically (zip codes, counties, MSAs, etc.), but in special circumstances (e.g., children’s hospitals, cancer hospitals, specialty units) may also be described by patient populations. Should include not only those the hospital would like to serve, but those available to serve (including through emergency department). Often, this will be the hospital’s service area which is generally a geographic area comprising 75 percent of the admissions.
Data for the CHNA should include federal, state and local sources and identify the following:
Data can be obtained from a variety of sources, including the following:
The following organizations or groups may be considered for community input:
One way to gather, assess and use community input is to form a group of interested stakeholders from both within and outside of the hospital (could be called an “Advisory Council”) to assist with considering the data and input and identifying and prioritizing needs.
The hospital should review each significant need and consider the following:
For each significant need addressed in a CHNA, the implementation strategy should include the following:
While those may be a resource considered as a part of the CHNA, it is extremely unlikely that those activities followed the steps and included the level of external input required for CHNAs.
All significant needs are not required to be addressed. The implementation strategy must address each significant health need, indicating whether the need is one the hospital will address or not. If the need is not being addressed by the hospital, indicate the reason (e.g., limited resources, lacking expertise, etc.).
With changes in reimbursement and more stringent regulations, providing long-term care and assisted living services is more challenging than ever. Our consultants can help you meet those challenges. We provide expert assistance to long-term care and assisted living providers in many areas including those described below.
We assist in the conversion of space for nursing home and assisted living use. We can advise on space requirements, timing of notifications and notice requirements, and survey process.
We assist you in meeting licensure requirements and waiver regulations for participation in an assisted living waiver program. We can help with conversion of space and prepare notification filings to initiate licensure, certification under a waiver program and, if necessary, survey processes.
Our Certificate of Need expert was director of Ohio’s Certificate of Need program before joining our team. She will prepare and submit your Certificate of Need application and support you throughout the process, including support for administrative hearings.
We assist you in meeting licensure and certification requirements throughout the planning and implementation of bed sales and acquisitions, ensuring that the beds remain “valid” throughout the process. Serving as your liaison with Ohio Department of Health (ODH), we will prepare notification filings to initiate licensure, certification and survey processes.
Do you need additional long-term care beds? Are you struggling with low occupancy rates? We bring providers together to relocate beds to areas where they can be better utilized to enhance operations. We assist you by negotiating terms for bed transaction agreements and ensuring your interests are met throughout the process. Specifically, we provide:
Our nursing home consultant will ensure that your interests are met during negotiations for allocation of the franchise permit fee associated with bed sales and acquisitions. We also advise on the optimal time for de-licensure of beds being relocated and the licensure of beds at the receiving facility to minimize your franchise permit fee liability.
State regulations for acute care services can change without providers having any knowledge of, or input on, the change. We can monitor regulations, advise you on proposed changes and provide public comment where appropriate. We can help ensure that your interests are addressed and that your service is in compliance. In addition, we can prepare your request for a waiver or variance and work with the Ohio Department of Health (ODH) to address specific concerns, such as:
Our director of regulatory services has worked with experts to develop rules for the Health Care Services (HCS) program, covering cardiac catheterization, open heart surgery, radiation therapy and pediatric intensive care unit services.
She developed and implemented the HCS program for the ODH and was the program’s administrator from its inception in 1997 through 2009. We can assist with the following:
Our director of regulatory services has 28 years of involvement with hospital registration as a program administrator with the ODH. Additionally, our director has provided consultation to the ODH regarding registration policy and rules and can help ensure that your registration is accurate. If you are having registration issues, we can work with the ODH to resolve problems and correct mistakes.
Cardiac catheterization programs are required to have at least two licensed physicians on staff who are knowledgeable about the laboratory’s protocols and equipment. These physicians must be credentialed to provide cardiac catheterization services, however, guidance from the Ohio Department of Health (ODH) suggests that these physicians do not have to be credentialed to perform all procedures within the program’s scope of service.
For example, a level 1 service may have one physician credentialed to perform all diagnostic cardiac catheterization procedures and one physician only credentialed to perform device implantation.
For a level II or level III service, individual physicians do not have to provide all therapeutic cardiac catheterization procedures within the service’s scope of service. However, because a level II and level III service must operate on a 24/7 basis to perform primary percutaneous coronary intervention (PCI), at least two physicians should be credentialed to perform primary PCI to ensure adequate coverage.
Cardiac catheterization programs are required to have at least two licensed physicians on staff who have been credentialed to provide cardiac catheterization services by meeting all of the following criteria:
In addition, physicians performing percutaneous coronary intervention (PCI) who have not performed PCI prior to March 20, 1997, must have completed a fellowship training program in interventional cardiology.
It’s likely time to review your credentialing criteria to ensure that your physicians performing cardiac catheterization procedures meet these requirements.
If a level I or level II cardiac catheterization service provides emergency care outside the designated scope of services, it must provide written notice to ODH within 48 hours of the incident. While maintaining patient confidentiality, the notification must include the following:
Be sure to incorporate this notification requirement into your service’s policies and procedures and ensure that timely notification is provided.
Cardiac catheterization services are required to obtain a signed informed consent form from each patient or patient designee prior to the procedure. For a level I or level II service, the informed consent must include an acknowledgment that the procedure is being performed in a cardiac catheterization service without on-site open heart surgery and that, if necessary as the result of an adverse event, the patient may be transferred to a receiving service for medical/surgical management.
While a general hospital informed consent may be used for a level III service, a level I or level II service must use an informed consent that includes this language.
A cardiac catheterization service specific rule from the Ohio Department of Health (ODH) provides that major complications and emergency transfers should be reviewed at least once every 90 days by the quality assessment review process. However, the ODH general quality assessment and performance improvement rule requires the program to hold regular meetings, chaired by the medical director of the health care service or designee, at least within 60 days after a death or complication to review all deaths and complications and to report findings. To be compliant, providers must meet the 60-day requirement for review of any death or complication.
The Ohio Department of Health requires an appropriate number of scrub nurses or technicians and a circulating nurse for each open heart surgery procedure. The number of staff present at each procedure should be based on the needs of the surgeons and the patient. At a minimum, there must be two staff present for each procedure, including a circulating nurse and one scrub nurse or technician.
Be sure to include these requirements in your open heart surgery service’s policies and procedures and document compliance.
Effective August 1, 2017, the Ohio Department of Health requires a provider of an adult open heart surgery service to utilize a multidisciplinary approach to patient care. This approach is to include meetings between cardiologists and cardiovascular surgeons as necessary to address the needs of patients with complex cardiovascular disease. In addition, as part of the service’s quality assessment and performance improvement process, there must be a periodic review and evaluation of the multidisciplinary meetings.
Be sure to include these requirements in your open heart surgery service policies and procedures. Also, document the meetings, reviews and evaluations.
An Ohio Department of Health (ODH) rule requires that providers of adult open heart surgery services conduct a thorough internal review of any surgeon with a combination of high risk adjusted mortality and low individual surgeon volume. ODH also requires providers to have a written policy requiring the documentation of the internal review of surgeons with this combination. Rules further specify that a volume goal of at least 25 open heart procedures per surgeon per year is recommended.
Be sure to include this requirement in your open heart surgery service’s policies and procedures and also document the surgeon review process.
The Ohio Department of Health recently added a new requirement for all Chapter 84 health care services listed below:
• Adult cardiac catheterization
• Adult open heart surgery
• Solid organ transplantation
• Bone marrow transplantation
• Pediatric intensive care unit
• Radiation therapy
• Pediatric cardiac catheterization
• Pediatric cardiovascular surgery
Beginning August 1, 2017, each service must have an ongoing process for ensuring the competence of “staff members,” defined as the administrator and individuals providing direct care to patients on a full-time, part-time, temporary, contract, or voluntary basis. This process must include a periodic assessment and re-determination of necessary skill levels for each staff position practicing within the health care service. Note that this requirement cannot be met by providing training – there must be an assessment of skill level for each staff member. At least every 36 months, a performance evaluation must be conducted stating whether each staff member has achieved the skill levels for the position.
Be sure to include this requirement in your policies and procedures and document the assessment in each individual’s personnel file, explicitly stating whether the staff member has achieved the skill levels for the position.