Standard of Care: Foundations for Wound Management

Last updated on 8/24/23 | First published on 7/3/23 | Literature review current through Oct. 2024 [cite]

Authors: Tiffany Hamm BSN, RN, CWS, ACHRN, UHMSADS, Elaine Horibe Song MD, PhD, MBA, Mike White MD, UHM, MMM, CWS, Topic editors: Cathy Milne APRN, MSN, CWOCN-AP, Amy Smith JD, RN, PHN, more...

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ABSTRACT

It is understood that "standard of care" is the level of care widely accepted in the medical community.[1] Centers of Medicare and Medicaid Services' (CMS) highlights the importance of adhering to standard of care for chronic wound management to promote optimal outcomes for patients. In addition, having a comprehensive understanding of the standard of care in wound management is essential not only for delivering high-quality care and achieving favorable patient outcomes but also for reducing exposure to legal risks and improving cost-effectiveness.

These standards encompass the implementation of a comprehensive wound care management plan. While specific components, such as vascular assessment are pivotal to lower extremity wounds, and compression therapy is the mainstay for venous leg ulcer management, it is crucial to emphasize that these elements should not overshadow the importance of other components of the standard of care in wound management such as infection control, nutrition optimization and other interventions that address the underlying cause of the ulcer(s).

This topic lists the elements and documentation requirements necessary for clinicians to demonstrate adherence to the standard of care in wound management.

INTRODUCTION

Overview

Originally a legal term, "standard of care" is the benchmark that determines whether professional obligations to patients have been met.[2] Failure to meet the standard of care is negligence, which can carry significant consequences for clinicians.[2] As a result, the standard of care is what medical malpractice cases are built upon.[2]

It is understood that "standard of care" is the level of care widely accepted in the medical community.[1] Although these standards are not stored or consolidated in any specific location, they represent the widely accepted best practices embraced by healthcare professionals through diverse training and education, and they ultimately guide the implementation of protocols.[1]

In the wound care community, healthcare professionals might be familiar with the term "standard wound care", as it is clearly outlined by the Centers of Medicare and Medicaid Services' (CMS) on the National Coverage Determination for Hyperbaric Oxygen Therapy (NCD 20.29)[3] and several Local Coverage Determinations (LCDs) for wound care [4][5][6][7] (see topic " Medicare Coverage Determinations for Wound Care).

In order to achieve the standard of care, wound management interventions must also align with established guidelines for medical and surgical treatment. This topic lists the elements and documentation requirements necessary for clinicians to demonstrate adherence to the standard of care in wound management.

Background

Definitions

Standard of care: the standard of care is a legal term, not a medical term:

Basically, it refers to "a measure of the duty that practioners owe patients to make medical decisions in accordance with any other prudent practioner's treatment of the same condition in a similar patient."[8] State legislatures, administrative agencies, and courts define the legal degree of care required, so the exact legal standard varies by state.[2]
Standard of care has also been described as "…not a guideline or list of options; instead, it is a duty determined by a given set of circumstances that present in a particular patient, with a specific condition, at a definite time and place."[9]

Clinical practice guidelines (CPGs): CPGs are recommendations on how to diagnose and treat a medical condition. Guidelines summarize the current medical knowledge, weigh the benefits and harms of diagnostic procedures and treatments, and give specific recommendations based on this information. Additionally, they should incorporate information regarding the scientific evidence that underpins these recommendations. It is crucial for CPGs to undergo regular updates to ensure their ongoing relevance and accuracy. Unlike directives (i.e. orders or official notices that come from an authority), guidelines aren’t legally binding.[10]
Policies and procedures:

Policies: policies are a set of principles, rules and guidelines adopted by the healthcare organization and around which work is accomplished. Policies can be amended, changed, or superseded from time to time.[11][12]
Procedures: procedures create a roadmap showing how a policy can be implemented or how a service can be delivered. Procedures refer to the various types of tasks performed by employees, resources that are necessary, boundaries of the service, and contingency plans for executing an alternative if the policy cannot be implemented (i.e. plan B).[13]

Note: the standard of care can vary depending on factors such as time, location, and individual circumstances. CPGs, policies and procedures do not contemplate all possible clinical scenarios. Therefore, as a general rule, clinicians should be ready to exercise judgment in making decisions considering the unique circumstances of each patient, while closely adhering to the standard of care.[9]

Relevance

Having a comprehensive understanding of the standard of care in wound management is essential not only for delivering high-quality care and achieving favorable patient outcomes but also for reducing exposure to legal risks and improving cost-effectiveness.
The standard of care is a central piece in medical malpractice lawsuits.[2] To win a malpractice case, the plaintiff (e.g., a patient or representative) must prove four elements [2]:

The clinician had a duty to provide standard care
The clinician failed to meet the standard of care
The plaintiff suffered harm, and
The harm was caused by the clinician's failure to meet the standard of care.

In the context of wound management, the delivery and documentation of standard of care is also important in order to justify medical necessity for adjunctive interventions such as hyperbaric oxygen therapy for diabetic foot ulcers. It is well known that Medicare does not support continuing a plan of care or therapy that is ineffective over a 30-day period.[14] See sample CMS statements below [14]:

“Failure to respond to standard wound care occurs when there are no measurable signs of healing for at least 30 consecutive days."
"Wounds must be evaluated at least every 30 days during administration of HBO therapy."
"Continued treatment with HBO therapy is not covered if measurable signs of healing have not been demonstrated within any 30-day period of treatment.”

STANDARD OF CARE IN WOUND MANAGEMENT

This section outlines elements of standard of care in wound management. While the components outlined below are relevant across different types of wounds, it is important to note that additional elements may be applicable depending on the underlying cause of the wound.

Clinicians may opt to employ the mnemonic "BIONIC" to recall components of standard of care in wound management described by CMS' NCD 20.29 [3]:

B for Blood Flow: assessment of a patient’s vascular status and correction of any vascular problems in the affected limb, if possible
I for Infection Control: debridement to remove devitalized tissue (if no contraindications to debridement), and other interventions to resolve infection that might be present
O for Offloading: documentation of efforts for adequate offloading
N for Nutrition: optimization of nutritional status
I for Interventions: interventions to treat the cause(s) of the ulcer and provide adequate local wound care
C for Comorbidities: for instance, optimization of glucose control, smoking s, etc.

Standard of Care Summarized

Table 1 below provides a brief description and additional resources for each of the components of standard of care in wound management, as well as elements that need to be included in clinicians' documentation and related quality measures that can be reported in CMS' Quality Payment Program.

Table 1. Standard of Care in Wound Management

* Interventions should address the underlying etiology(ies) of the ulcer(s). Examples provided below do not apply to all patients. ** Comorbidities that impede healing of the ulcer should be addressed for all patients. Hyperglycemia is one of the various comorbidities that may delay healing. [4][5][6][7][15][16]

Standard of Care	Comments and Resources	Documentation (at minimum)	Related Quality Measures
B for blood flow Vascular assessment	An important part of the structured assessment of patients with leg ulcerations is vascular assessment. For more information refer to: Section 'Noninvasive arterial tests’ in topic "Arterial Ulcer - Introduction and Assessment"	Presence or absence of lower extremity pulses Blood supply to ulcer, assessed with non-invasive arterial vascular tests: For patients with arterial calcification or diabetes, consider use of audible handheld Doppler, toe pressure, transcutaneous oximetry (TcPO2). Indications for urgent imaging and revascularization: Continuous doppler wave ultrasound with monophasic flow Toe pressure < 30 mmHg TcPO2 < 25 mmHg ABI<0.5	Non-Invasive Arterial Assessment of patients with lower extremity wounds or ulcers for determination of healing potential See 'Quality Measures' in topic "Arterial Ulcers - Guidelines and Quality Measures"
I for Infection Control	Soft tissue infection should be diagnosed clinically, based on the presence of local or systemic signs or symptoms of inflammation. Tissue biopsy or quantitative, validated swab cultures, or biofluorescent scans may be used to confirm diagnosis of infection and to guide antibiotic therapy.[17] For healable chronic wounds, interventions to manage infection include topical antimicrobial agents, systemic antibiotics and debridement.[18][19] For healable wounds, debridement is indicated whenever necrotic tissue as well as cellular or proteinaceous debris are present on an open wound in order to keep the wound in an active state of healing. For more information infection and bioburden management see topics below: "How to Determine Healability of a Chronic Wound" 'Ulcer complications - Soft Tissue Infection' in topic "How to Assess a Patient with Chronic Wounds" 'Infection management' in topic "Antimicrobial Stewardship in Wound Care" "Debridement"	Assessment for infection: absence or presence of clinical signs and symptoms of infection If wound infection is suspected, wound culture (i.e. Levine technique) to confirm diagnosis and guide antibiotic therapy.[20] Measures taken to address existing infection and bioburden management
O for Offloading	Offloading is one of the cornerstones of diabetic foot ulcer (DFU) and pressure ulcer/injury (PU/PI) treatment and prevention. Other treatments besides those meant for offloading do not eliminate the underlying mechanism resulting in a DFU or PU/PI - abnormal pressure and shear stress are still present and long-term offloading is necessary. 'Offloading' in topic "Diabetic Foot Ulcers- Treatment” 'Pressure Redistribution' in topic “Pressure Ulcer/Injury Treatment”	Type of offloading device used, appropriate to the condition being treated and anatomic location. Examples include: Non-Removable: Total Contact Cast Removable: Removable walker, half shoe Other: Crutches, wheelchair Protectors (heel, elbow) Seating Support Surfaces Mattress/Bed support surfaces	Adequate Off-loading of Diabetic Foot Ulcers at each visit, appropriate to location of ulcer See 'Quality Measures' in topic "Diabetic Foot Ulcers - Clinical Guidelines and Quality Measures"
N for Nutrition Optimization of Nutritional Status	Nutrition plays an essential role in wound healing and care, and nutritional support needs to be considered a fundamental part of wound management. Standardized tools such as the "Nestlé MNA" and "Self-MNA®" by Nestlé can be used to screen for malnutrition. For details, see resources below: 'Nutritional Screening' in topic “How to Screen, Assess and Manage Nutrition in Patients with Wounds” 'Nutritional Assessment' in topic “How to Assess a patient with Chronic Wounds”	Nutrition screening and re-screening For patients who are malnourished or at risk for malnutrition, as identified during screening: referral to a registered dietitian/nutritionist Food intake by nursing staff CBC, BUN/Creatinine (serum), albumin/prealbumin (serum), glucose and hemoglobin A1C (serum) [21] Measures taken to address nutritional deficiencies For chronic wounds, oral supplementation (e.g. with arginine, glutamine, and β-hydroxy-β-methylbutyrate) may be added.[22][23][24] See section 'Documentation' in topic "How to Screen, Assess and Manage Nutrition in Patients with Wounds"	Patient Reported Nutritional Assessment and Intervention Plan in Patients with Wounds and Ulcers Preventative Care and Screening: Body Mass Index (BMI) Screening and Follow-Up See 'Quality Measures' in topic "Diabetic Foot Ulcers - Clinical Guidelines and Quality Measures"
I for Interventions*	See sample interventions below	See sample interventions below	See sample interventions below
Compression therapy	Venous hypertension and hemodynamic abnormalities lead to inflammatory alterations with microcirculatory changes that can result in venous stasis and venous leg ulcers (VLU). Compression therapy plays a crucial role in the treatment of patients with venous leg ulcers and remains the cornerstone of VLU care. For details, refer to: "Compression therapy" “Venous Ulcers - Treatment and Prevention”	Recommended venous disease classified using the Clinical class, Etiology, Anatomy, and Pathophysiology (CEAP) classification (confirmed by duplex scan) [16] Compression level: standard compression (30-40 mmHg resting pressure) or modified compression (low resting pressure, i.e., 20-30 mmHg) Type of compression device: for instance, for patients who ambulate, multi-component bandages or inelastic compression devices (i.e., short stretch, Unna boot); for patients who do not ambulate, elastic bandages Exercise Leg elevation Oral pentoxifylline if used Protection of periwound from exudate Venous Clinical Severity Score (VCSS) is recommended to assess changes in response to therapy [16]	Adequate Compression at Each Visit for Patients with Venous Leg Ulcers (VLUs) Appropriate to Arterial Supply See 'Quality Measures' in "Venous Ulcers - Overview"
Local wound care	The dressing type will change as the needs of the person and their wound change. Dressing choice needs to consider characteristics of the wound, unit costs, clinical effectiveness, ease of use, clinician's and patient's preferences, and indications and contraindications. For details see topics on each type of condition under the section 'Local Wound Care' and also refer to resources below: “Dressings Essentials” Prep and Dress Tool	Appropriate use of dressings for moisture management as indicated by wound characteristics Maintenance of a clean, moist bed of granulation tissue Control of exudate, avoiding maceration of adjacent intact skin Weekly to monthly wound evaluations of ulcer size and healing progress
C for Comorbidities*	Includes the identification and correction of systemic causes of impaired healing, as well as proper management of systemic diseases and medications. See samples below	See samples below	See samples below
Optimization of glucose control	Elevated blood sugar levels (hyperglycemia) are associated with increased stiffness of blood vessels, leading to slower circulation and microvascular dysfunction, and reduced tissue oxygenation.[25] For instance, glycemia, as measured by HbA1c, may be an important predictor of neuropathic DFU. It has been shown that for each 1.0%-point increase in HbA1c, the daily wound-area healing rate slows by 0.028 cm² per day.[26] For details, refer to: “How to Assess a Patient with Chronic Wounds” Section 'Intensive glucose control' in topic "Diabetic Foot Ulcer - Treatment"	Serial blood glucose Target HbA1c <7% with strategies to minimize hypoglycemia Measures taken by other providers to address poorly controlled blood glucose	Diabetes: Hemoglobin A1c Poor Control. See “Diabetic Foot Ulcers- Clinical Guidelines and Quality Measures”
Counseling on tobacco use	Nicotine is a vasoconstrictor that reduces nutritional blood flow to the skin, resulting in tissue ischemia and impaired healing of injured tissue.[27] "Principles of Wound Healing"	For current smokers or tobacco users: document advice to quit, including discussion of cessation medications and cessation strategies If patient refuses or is non-adherent to the interventions above, document reason	Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention

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NOTE: This is a controlled document. This document is not a substitute for proper training, experience, and exercising of professional judgment. While every effort has been made to ensure the accuracy of the contents, neither the authors nor the Wound Reference, Inc. give any guarantee as to the accuracy of the information contained in them nor accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omissions in the contents of the work.

REFERENCES

Topic 1981 Version 2.0

Standard of Care: Foundations for Wound Management

Standard of Care: Foundations for Wound Management

ABSTRACT

INTRODUCTION

Overview

Background

Definitions

Relevance

STANDARD OF CARE IN WOUND MANAGEMENT

B for blood flow

I for Infection Control

O for Offloading

N for Nutrition

I for Interventions*

C for Comorbidities*

REFERENCES

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