Implementing the new CMS guidelines for wound care: areas for potential citations are explained by Jeffrey M. Levine, MD, AGSF, CMD; Marilyn Peterson, RNC, MSN; and Fay Savino, RN, BSN, MA.

The Centers for Medicare & Medicaid Services' (CMS) new pressure ulcer guidelines for surveyors have arrived. (1) Federal Tag 314 (F314) is replaced completely by a 40-page document that vastly expands protocols for investigating pressure ulcers (see tables 1 and 2 for F-tags applicable prior to and in the new CMS guidelines). (2) In addition, surveyors are directed to consider other F-tags during investigations for compliance. The volume of detail written into the new F314 is extraordinary and essentially amounts to a "clinical practice guideline" for wound care directed to both facility staff and surveyors. Along with the Quality Measures posted on CMS's Nursing Home Compare Web site (www.medicare.gov/nhcompare/home.asp), these guidelines increase the incentive for facilities to strengthen their wound care programs.

We suggest that facilities first become familiar with the guidelines, and then completely review their internal systems for wound care, including the policy and procedure (P & P) manual. Good wound care is dependent on many aspects of the care process, and this is reflected in the new CMS guidelines, which include emphasis on resident assessment and care planning. New citations are added for lack of physician and medical director involvement with wound care, as described below. Since emphasis is added on physician notification and the correct use of products, internal review should include the responsiveness and effectiveness of physician services. Remember that wound care is interdisciplinary and includes not only medicine and nursing but also nutrition, rehabilitative services, and social work.

Risk Assessment

Risk assessment is an important component of any wound care program. Risk assessment for pressure ulcers should be performed on every resident upon admission along with a complete body check for preexisting ulcers. The Braden Scale is a popular measure, although others are available. (3) Whatever scale is employed, it should be administered upon admission, then weekly for one month, and then quarterly. Because the risk for pressure ulcers rises with changes in medical status, the risk-assessment scale should be repeated whenever a medical illness or change in status occurs, including such events as stroke, delirium, fracture, new onset of diabetes mellitus, or any infection, such as UTI or pneumonia.

Accuracy is critical when performing a risk assessment. When the medical record is reviewed by a surveyor, each subscale should correspond accurately to the patient's condition at that time. Therefore, in-services on use of the assessment scale are important components of the wound care program. Conduct in-services for all nurse managers and other individuals delegated the task of completing the scale. Quality assurance (QA) review is recommended to ensure accurate determination of the subscales.

The system for documentation of risk requires facility-wide review, beginning with review and revision of the P & P manual and the charting system's organization. An important consideration is the construction of the medical record for ease of review. Risk-assessment results should be congregated in a separate section, thereby allowing for ease of retrospective review of documentation timeliness and accuracy by QA and survey personnel. An alternative method is to place the risk-assessment documentation within the interdisciplinary notes in a clearly marked entry.

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The Prevention Plan

The facility should maintain an armamentarium of prevention modalities for residents deemed at risk for pressure ulcers. The most basic is the turning and positioning schedule, which is supplemented by pressure-relief solutions such as heel pads, seating cushions, mattress overlays, and specialty mattresses. (4) The new CMS guidelines contain an introduction to support surfaces, including static and dynamic pressure-reduction devices. Static pressure redistribution devices simply are cushioned surfaces, while dynamic devices have intrinsic movement. An example of a dynamic pressure-reduction surface is the alternating pressure air mattress.

The basic turning and positioning schedule is every two hours, but some patients at risk require even greater frequency because of compromised tissue tolerance. (5) Whether or not the facility's P & P manual requires documentation with turning and positioning flow sheets, an auditing system must exist to enforce facility-wide compliance with turning once a resident is deemed at risk.

Several resident characteristics affect the ease of enforcing a turning schedule. Residents with feeding tubes or those on ventilators, for example, may not be turned in the same manner as those not attached to life support. Residents with contractures can be turned but may need specially positioned pillows or cushions to maintain proper pressure relief. Thus, an individualized care plan can provide a guide to pressure-relief management.

Mobilization strategies are always a component of pressure-sore prevention. These include physical therapy and occupational therapy involvement for body strength improvement, balance training, and adaptive equipment. These therapists often are able to provide suggestions for proper seat cushions and positioning devices. A speech therapy consult is helpful when determining ability to swallow and the need for special diets and therapies.

An individualized care plan should be constructed for each resident deemed at risk by the risk-assessment scale. This care plan should take into consideration factors that interfere with pressure relief, such as the life-support modalities mentioned above, and should address pressure-relief devices currently in use. Incontinence management for relief of moisture and fecal contamination is a must in any skin-management plan. In addition, the care plan should address nutrition and refer to the appropriate section of the medical record that covers this. It is important for QA efforts to review the appropriateness as well as the timeliness of care plan interventions.

Ulcer Documentation and Treatment

Pressure sore documentation should begin upon admission if a pressure ulcer is present, preferably within 24 hours of the resident's entering the facility. Once an ulcer is detected, whether the resident is admitted with one or it is facility-acquired, a physician should perform a timely examination. Residents with pressure sores usually require review of their medical problems and a nutrition consultation, and the new CMS guidelines contain revised pressure ulcer investigative protocols that specifically target physician notification for changes in the resident's condition or wound(s).

A pressure sore's location can sometimes assist in pinpointing system problems that require intervention. For example, bilateral ischial ulcers frequently result from improper seating. Ulcers on the perineum that are surrounded by dermatitis may indicate fungal infection or inadequate continence care.

The first step in proper wound documentation is determining the correct diagnosis. The new CMS guidelines specifically mention arterial/ischemic ulcers, venous insufficiency ulcers (formerly known as the stasis ulcer), and diabetic neuropathic ulcers. It is critical that the diagnosis be made as early as possible and that the diagnostic process be carried forth with all disciplines, not only for surveyors and QA, but also for risk-management purposes. We therefore advise obtaining a physician consultation for assistance with diagnosing lower extremity ulcers and for clarification of ulcer type. Noninvasive vascular studies can be of crucial assistance in documenting ulcers associated with peripheral vascular disease. Consistency of documentation is important: If an ulcer is designated a pressure ulcer in one place and an arterial/ischemic ulcer elsewhere, this may spell trouble when a surveyor investigates the resident.

For documentation purposes, simply stating the stage of the ulcer is insufficient. Description of the wound should be accompanied by measurements of length, width, and depth, as well as notation of odor and presence of drainage. The new CMS guidelines contain specific definitions of tunneling, sinus tract, undermining, eschar, slough, exudate, and granulation tissue. These definitions, as well as the staging system, need to be understood by staff entering wound documentation into the medical record. The best documentation contains not only stage and measurements, but also a narrative description of the wound, current treatment, and response to treatment. It is helpful to document the treatment in progress and the rationale for that treatment (i.e., absorbs drainage, treats infection, protects surrounding skin, debrides eschar, etc.).

Documentation in the medical record should be organized to facilitate QA and/or surveyor review. As with the risk-assessment results discussed above, we recommend congregating the wound care flow sheets and documentation in a separate section. This, however, does not eliminate the need to discuss wound prevention and care in the narrative nursing notes.

The presence of pain is an important consideration when caring for wounds, and this is indeed reflected in the new CMS guidelines. Pain can result from the wound itself or can be a consequence of prevention measures or treatment. (6) Turning and positioning a frail resident with arthritis and contractures can be painful for him/her. Dressing changes can induce pain, with positioning of the resident and removal of adhesives. Pain should be assessed and described in the wound documentation note and addressed in the care plan and physician record.

Photographs can provide excellent supplementary documentation of wounds but should never take the place of written descriptions. Each facility must decide whether photographs should be part of its wound care documentation program. This decision should not be taken lightly, as the incorporation of photographs into wound care documentation is a decision that will require new P & Ps, staff training, expenses for a camera and printing, and incorporation of the photographs into the charting system.

Physician Involvement and Wound Care Formulary

The previous CMS guidelines to surveyors were silent on the issue of physician involvement in wound care. A surveyor now is advised to investigate related F-tags for associated citations such as not notifying the physician of changes (F157), not using correct products (F281), not providing adequate physician supervision for wound care (F385), and not involving the medical director in the wound care program (F501) (table 2). Facilities therefore have ample incentive to get their medical directors on board with reviewing and implementing a stronger wound care program, and educating their physicians about wound assessment and the correct use of products.

The medical director is delegated the task of supervising the primary care physicians in their wound assessment and documentation. All too often, primary care physicians rely on the nursing staff to perform wound assessments and decide on treatment modalities. The physician assessment should reflect the presence and location of the wound, as well as treatment and response to care. The medical documentation also should discuss conditions such as diabetes mellitus, peripheral vascular disease, weight loss, and stroke, which may adversely affect response to treatment.

Primary care physicians should be familiar with advanced wound care modalities and their proper use. The new CMS guidelines state, "[N]ot all products are appropriate for all pressure ulcers. Wound characteristics should be assessed throughout the healing process to assure that the treatments and dressings being used are appropriate to the nature of the wound." The facility should review its formulary for wound care products and make sure that the products are used properly. To accomplish this goal, a restricted formulary may be advantageous, with in-services for physicians and nurses on appropriate use. Efforts should be made to keep these products in stock to avoid delays when treatments are needed.

Was the Ulcer Avoidable?

The new CMS guidelines contain new detailed wording for surveyors to define whether an ulcer was avoidable or unavoidable. In addition, the investigative protocols present detailed instructions for inquiry into wound prevention, interventions, care plan revisions, and staff interviews to determine citations. The new CMS definition for "avoidable" is as follows:

  "Avoidable" means that the resident developed a pressure ulcer and
  that the facility did not do one or more of the following: evaluate
  the resident's clinical condition and pressure ulcer risk factors;
  define and implement interventions that are consistent with resident
  needs, resident goals, and recognized standards of practice; monitor
  and evaluate the impact of the interventions; or revise the
  interventions as appropriate.

For ulcers that develop or worsen within the facility, we recommend a comprehensive narrative note that summarizes what was done to prevent the ulcer and/or what was done to stop it from getting worse. This note preferably should be written by the medical director and should incorporate information regarding the resident's underlying medical condition, nutritional status, and advance directives. To facilitate the surveyor's review, this note should refer to specific dates that interventions were performed and where the information can be found.

Reverse Staging and the PUSH Tool

"Reverse staging" and the Pressure Ulcer Scale for Healing (PUSH) Tool are discussed in the new CMS guidelines, and these items bear some clarification and discussion. Experts agree that a wound does not heal in a reverse sequence (i.e., stage IV to stage III to stage II, etc.). The National Pressure Ulcer Advisory Panel (NPUAP) has taken the position that once an ulcer has reached an advanced stage, that ulcer should not be "downstaged" as it heals; NPUAP says that in the ulcer documentation, this lesion should be referred to as a "healing stage IV" rather than downstaging to stages III, II, or I. However, this position is at odds with the requirements of the RAI User's Manual Version 2.0, which instructs staff to code ulcers using standard staging criteria. We therefore recommend that nursing facility staff describe ulcers as they appear and not employ the NPUAP recommendation to avoid downstaging. Whatever staging system is used, it should be stated clearly in the facility's P & P manual.

NPUAP has advocated the use of the PUSH Tool, which offers the advantage of calculating a single numeric value for an ulcer, combining scores for length, width, exudate, and presence of eschar. (7) This tool does not supplant regular staging, measurement, and a narrative description of the wound. The PUSH Tool is optional and will require additional flow sheets, education, and training; revision of wound care P & Ps; and QA activities to ensure that the tool is being used correctly. Facilities should carefully consider this tool and determine whether it fits with their wound care program.

Nutrition and Hydration

Nutrition and hydration comprise a substantial part of the new CMS guidelines, referencing other F-tags including F325 (Nutrition) and F327 (Hydration). The guidelines present a concise review of the importance of nutrition to skin integrity and wound care, and provide an overview of nutritional management, including recommended caloric intake and relevant laboratory tests. The new guidelines send a clear message that the nutritionist cannot take a backseat in the wound care process. Nutritional assessments for residents at risk for or having wounds should be timely, with special attention to malnutrition and weight loss, with provision of proper calories and fluids. (8) Wounds may take a long time to heal, and the nutritionist cannot wait until the next quarterly MDS assessment to reassess the resident. We recommend that the nutritionist engage directly with wound care personnel. Also, lines of communication between the nutritionist and physician should be strengthened.

Resident Choice and Advance Directives

The new CMS guidelines broaden the scope of pressure ulcer care by including issues of resident choice and advance directives. The guidelines recognize the right of the nursing home resident to make informed choices and refuse treatment. Facilities now are mandated to discuss the resident's condition, treatment, expected outcomes, and consequences of refusing treatment with either the resident or his/her legal representative. This concept is not new, as resident rights have been woven into the original Nursing Home Reform Amendments passed in 1987. What is new is the mandate to apply these concepts directly to ulcer care.

The guidelines also contain instructions that care must be delivered in accordance with residents' wishes as expressed in valid advance directives. There is a specific notation that a do not resuscitate order is limited only to resuscitative measures and is not applicable to other treatments and services. The incorporation of resident choice and advance directives into the CMS guidelines for wound care strengthen the mandate for resident and family education and inclusion in care plan meetings. Given the cognitive debility of many residents with pressure ulcers, as well as the complexity of end-of-life care decisions, the role of the social worker in wound care must be emphasized. The social worker is the team member who usually invites families to meetings and takes care of advance directives.

Summary

The new CMS guidelines to surveyors for pressure ulcers vastly expand the investigative protocols for wounds and add new F-tags for citing facilities for deficiencies in wound care. The guidelines cover risk assessment, documentation, monitoring, nutrition, advance directives, resident choice, and care planning. Areas for potential citations are expanded, including pain management, correct use of products, and physician involvement. There is now ample incentive to completely review and revise the facility's P & Ps for wound care. The medical director must be part of the team, and resources must be directed at implementing stronger oversight of the wound care program, including QA activities.

Jeffrey M. Levine, MD, AGSF, CMD, practices medicine in New York City at the Cabrini Medical Center. He is a Certified Wound Care Specialist, and he has served as a consulting expert on elder care to the U.S. Department of Justice, the New York State Office of Professional Medical Conduct, and the Centers for Medicare & Medicaid Services.

Marilyn Peterson, RNC, MSN, is certified by the American Nursing Association in gerontological nursing. As a former director of nursing and assistant director of education in long-term care, she has a reputation as a leader and clinician with expertise in wound care, specialized care for dementia, and continuous quality improvement.

Fay Savino, RN, BSN, MA, has been active in healthcare since 1965, holding positions in direct care, nursing management, and regulatory compliance as a former New York State surveyor. She has been an LTC consultant since 1992.

For more information, contact Dr. Levine at [phone]. To send comments to the authors and editors, e-mail [e-mail]. To order reprints in quantities of 100 or more, call [phone].

References

1. Centers for Medicare & Medicaid Services. Guidance to Surveyors for Long Term Care Facilities. CMS Manual System, Pub. 100-07 State Operations, Provider Certification, Transmittal 4; November 12, 2004. Available at: www.cms.gov/manuals/pm_trans/r4som.pdf.

2. American Health Care Association. Guidance to Surveyors--Long Term Care Facilities. The Long Term Care Survey. Washington D.C.: American Health Care Association, 2002.

3. Seongsook J, Ihnsook J, Younghee L. Validity of pressure ulcer risk assessment scales; Cubbin and Jackson, Braden, and Douglas scale. International Journal of Nursing Studies 2004;41:199-204.

4. Sprigle S. The NPUAP Support Surface Standards Initiative. Ostomy/Wound Management 2004;50:6-8.

5. Agency for Health Care Policy and Research. Pressure ulcers in adults: Prediction and Prevention. AHCPR Publication No. 92-0047. Rockville, Md.: U.S. Department of Health and Human Services, 1992.

6. Popescu A, Salcido RS. Wound pain: A challenge for the patient and the wound care specialist. Advances in Skin & Wound Care 2004;17:14-20.

7. Pompeo M. Implementing the push tool in clinical practice: Revisions and results. Ostomy/Wound Management 2003;49:32-6,38,40 passim.

8. Schols JM, de Jager-v d Ende MA. Nutritional intervention in pressure ulcer guidelines: An inventory. Nutrition 2004;20:548-53.

Table 1. F-tags applicable to wound care in the prior CMS guidelines

F314  Pressure sores                       CFR [section]483.25(c)(1)
F314  Pressure sore treatment              CFR [section]483.25(c)(2)
F272  Comprehensive assessments            CFR [section]483.20(b)(1)
F279  Comprehensive care plans             CFR [section]483.20(k)(1)
F282  Provision of care in accordance      CFR [section]483.20(k)(3)(ii)
        with the care plan

Table 2. F-tags applicable to wound care in the new CMS guidelines

F314  Pressure sores              CFR [section]483.25(c)(1)
F314  Pressure sore treatment     CFR [section]483.25(c)(2)
F272  Comprehensive assessments   CFR [section]483.20(b)(1)
F279  Comprehensive care plans    CFR [section]483.20(k)(1)
F282  Provision of care in        CFR [section]483.20(k)(3)(ii)
        accordance with the care
        plan
F157  Notification of changes     CFR [section]483.10(b)(11)(i)(B) & (C)
F280  Comprehensive care plan     CFR [section]483.20(k)(2)(iii)
        revisions
F281  Services provided meet      CFR [section]483.20(k)(3)(i)
        professional standards
F309  Quality of care             CFR [section]483.25
F353  Sufficient staff            CFR [section]482.30(a)
F385  Physician supervision       CFR [section]483.40(a)(1)
F501  Medical director            CFR [section]483.75(i)(2)