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he newly released survey protocol related to incontinence, urinary tract infections (UTIs), and catheter care contains more new information and guidance from the Centers for Medicare and Medicaid Services (CMS) than any of the materials released to date. In other words, this document is big—38 pages long—but the operational impact of the information is more significant than its length. Facility administrators, directors of nursing (DONs), corporate consultants, and managers must take a good look at the materials and establish processes to evaluate facilities’ compliance and steps to achieve understanding and compliance.
       The June issue of ECPN featured a continuing education (CE) activity on the definitional and clinical material in Federal Tag 315 (Tag F315). All managers should start with the definitional and clinical material in the introduction. Let us take the analysis 1 step further and look at the impact of the new Tag F315 release on operations, risk management, and compliance. It is important to focus on the intent of the materials and the current knowledge base of our building managers and clinical leadership related to the topics.

Document Review and Assessment of Risk

       The first strategy for operational success is to review the materials with the senior management team or corporate managers. This document reveals the CMS focus in this area and the structure of policies and programs it feels are foundational to compliance. The Tag release materials are very broad, containing definitions, practice guidelines, recommendations for behavioral programming and restorative programs, and standards for treatment as well as a very detailed survey protocol. This requires operational understanding and direction.
       It is important to identify the risk assessment process in the facility. The assessment of incontinence, fall, and skin issue risk is closely related to the process required in this Tag. When the facility is preparing for admission, risk assessment data in many areas need to be collected. We are aware that incontinence has an impact on resident placement. Proper identification of the type, history, and frequency of incontinence impacts the entire plan of treatment as well as the risk management issues related to the case. Admissions departments should begin the data gathering process for this area with careful interviewing of the family, the resident (when possible), and the physician (if necessary). Find out whether your facility has risk assessments for incontinence, catheter use, falls, and skin issues or pressure ulcers. Who fills them out, and from what data source? This does not involve nursing alone; it is an operational and interdisciplinary issue.

Educating All Staff

       Staff education is vital to achieve compliance with the new regulatory materials from CMS. It is necessary to find out what the staff use as working definitions and amend these to be consistent with the definition from the Minimum Data Set (MDS) 2.0 manual for incontinence (pages 3-119 and 3-120) as well as the related definitions from the introductory materials in the Survey Protocol from CMS. This will require a significant educational program that will extend into the nurse aide training programs, orientation programs, and related in-service topics for all departments. Forms and formats for documentation must have proper definitions, be included with the educational programs, and be integrated into the MDS data collection process. The shift to the new definitions is a significant change for most clinical staff as well as the documentation process for the MDS data. The educational programs should be planned strategically with senior managers and clinical staff. This is a definitional shift that will impact the documentation process, the assessment data, and the statistical reporting for the facility. The change that is currently proposed for the Quality Indicator/Quality Measure (QI/QM) database for the survey will make this data even more important as they relate to other regulatory activities for the facility. The short message is that the incontinence coding must adhere to the CMS standards. That is no small task, and it needs to be done as soon as possible. The educational programs must not only focus on the identification of incontinence but the type of incontinence and the interventions used to manage or decrease the frequency of incontinence. All members of the assessment team and the interdisciplinary planning team must use the same definitions and understand the implications from the survey protocol document. This should begin with a review of the CMS release related to Tag F315 and highlights for various members of the assessment and care planning teams. Regulatory success in this area is related to a universal understanding of the definitional and practice materials in the facility. This CMS release impacts the facility’s operational structure—not just nursing.

The Importance of Communication

       Communication with the medical director and the attending physicians is essential. The American Medical Directors Association has released practice guidelines for medical directors and attending physicians related to incontinence, UTIs, and catheter care, which should be considered when the medical director and the facility administrator establish the policy for the building. The survey protocol and the other material in the Tag F315 release contain considerable practice and procedure information as well as recommendations for indwelling catheter use and indications to treat a UTI in catheterized and noncatheterized residents. It is important for the medical director, DON or clinical managers, and the attending physicians to be aware of the standards presented by the protocol in these areas as well as the definitional materials that will impact the review of documents in the facility and will be reviewed as part of the survey. The Tag F315 document from CMS should be shared with the medical director first and then communicated with the attending physicians caring for residents in the facility. Policy and procedure documents as well as documentation formats should be available to the physicians. This will help to establish understanding about the status of the resident’s continence, catheter use or presence of a UTI, and the interventions or treatments being implemented by the team. Corporate or ownership groups should be communicating with nursing managers, consultants, and administrators to be sure that medical directors are informed and involved. It is important for the facility to identify if consultant pharmacists have made recommendations on prescriptive patterns or medication use related to these problems that have not been addressed by the physician and follow up to see that negative outcomes have not resulted. Has the physician properly identified the medical justification for continued catheter use according to the criterion in the Tag document under the “Indwelling Catheter Use” section?

Examining Policies and Procedures

       Take a look at policies and procedures related to incontinence, catheter use, prevention and treatment of UTIs, and related skin care issues. This is a significant issue for nursing managers and building administrators. Remember, the medical director has a regulatory responsibility in Tag F501 for review of care delivery policies. Make sure that catheter care policies and procedures match the definitional and procedural material in the protocol. Find out what equipment and supplies the staff members use and whether this is reflected in the procedures. Many times a facility will use new or improved supplies or products, and the procedure will not be changed. How do you train or orient new staff? What does the nurse aide training program teach? What procedures do the nurses use? These are just a few of the questions that need to be addressed. In the survey protocol, the surveyors are directed to note certain points of compliance when they observe the insertion of a catheter or incontinence care. (Remember that incontinence care includes perineal care.) How do your policies and procedures and staff competency compare with the protocol? You must be certain that your practice is up to that standard.
       Now let us examine your restorative program. How is it organized, and is it ready to assist with the assessment of incontinence and the development of toileting plans and retraining programs? The facility staff needs to understand that restorative is an important part of the care delivery process and the incontinence management programs. Incontinence is not normal for the aged population, and we need to aggressively improve the level of continence, functionality, and outcomes for residents.
       Bladder and bowel retraining and scheduled toileting programs are included in the restorative payment process as well as the core of restorative care plans. Your restorative nurse needs to have the current information in the Tag F315 document and be part of the operational team to implement programs to improve regulatory compliance and improve resident outcomes.
       Now let us look at the assessment process. First, does your MDS nurse understand the new definitions for coding in the revised MDS 2.0 manual, pages 119 and 120? Have those definitions changed the coding in your building? In other words, did your QI statistics change after the release of the new manual? If a resident is coded as incontinent, is the type of incontinence documented in the record? Are actions taken to individualize the interventions or toileting plan for this resident on the basis of his or her condition and ability to understand and restore bladder or bowel function? Is a urologist available for consultations if necessary? Is the assessment coding and voiding diary accurate so that a plan can be devised? Most facilities are just developing all these processes or organizing and improving plans that are in place. Remember, this is not just nursing. This new protocol is quite interdisciplinary in its approach—just look at the list of potential Tags for additional investigation at the end of the compliance section of the document.
       All facilities should assess what the residents and families know about incontinence and how staff members treat each individual situation. The interview in the protocol is in the second section of the survey tasks and is placed before the record review, care plan review, and staff interview. The staff need to know which questions will be asked of the residents and family members in order to prepare them for the inquiry from the surveyors. We cannot ignore this, because it can impact the extent or depth to which the survey team will review cases in this area of concern.
       Having open discussions with residents and families while protecting privacy and dignity is a must. Residents need to know that we are working to assist them to maintain or improve their continence.

Conclusion

       The strategies for success with this protocol are significant and interdisciplinary and need to be approached operationally. All members of the administrative and management team must have copies of the CMS release for Tag F315. Begin your review with a discussion of the intent of the protocol on the first page of the Tag F315 document. Your approach and focus need to return to these 5 intent statements as you implement the specifics of the protocol. All members of the team need to be involved. The medical director has a significant role in this process as well as the consultant pharmacist and any clinical consultants or managers. The goal will be to inform the front-line staff of the changes in practice and knowledge base for basic care delivery in the facility. Incontinence impacts almost every resident in the facility, and we need to raise awareness of the structure and content of these regulations.
       This is an operational, clinical, and interdisciplinary process, and the work to understand this new CMS directive has just begun.