NOTICES
PATIENT SAFETY AUTHORITY
DEPARTMENT OF HEALTH
Final Guidance for Acute Health Care Facility Determinations of Reporting Requirements for Pressure Injuries under the Medical Care Availability and Reduction of Error (MCARE) Act
[47 Pa.B. 2163]
[Saturday, April 8, 2017]This document outlines final guidance to help acute health care facilities in this Commonwealth make determinations about whether occurrences of pressure injuries meet the statutory definitions of incidents or serious events as defined in section 302 of the Medical Care Availability and Reduction of Error (MCARE) Act (MCARE Act) (40 P.S. § 1303.302). These recommendations were developed by a multidisciplinary work group consisting of staff from the Patient Safety Authority (Authority), two physician members of the Authority's Board of Directors, and the Department of Health (Department); representatives of the Hospital and Healthsystem Association of Pennsylvania, the Healthcare Council of Western Pennsylvania, the Pennsylvania Ambulatory Surgery Association and the Health Care Improvement Foundation; a patient representative; and a panel of wound care experts. The work group included individuals with backgrounds in medicine (including wound care), nursing (including wound, ostomy and continence nurses (WOCN)), administration and facility operations, regulation, and patient safety and health care quality. Draft guidance was issued for public comment at 46 Pa.B. 6198 (October 1, 2016). This document includes the responses by the Authority and the Department to the 15 correspondences (for example, comments and e-mails) received.
This guidance was developed to provide consistent and clear standards for the MCARE Act's reporting requirements for pressure injuries so that the Authority, the Department and health care facility staff have a shared understanding of the requirements. The subjects of these requirements were identified based on inconsistencies that are evident in the data collected by the Authority and the Department.
Implementation
The following principles have been approved by the Authority and the Department. The agencies will modify the Authority's Pennsylvania Patient Safety Reporting System (PA-PSRS) to support implementation of these standards and develop an education program to inform patient safety officers and other stakeholders of these changes. Education will be made available before the changes take effect in PA-PSRS. These principles will be effective January 1, 2018.
Concept of Harm
Patient safety event reporting in this Commonwealth was designed to be nonpunitive and does not include the concepts of preventability. The concepts of human error and preventability are not included in the 2014 Final Guidance for Acute Healthcare Facility Determinations of Reporting Requirements under MCARE Act. It is not necessary for an error to have occurred, or for harm to be preventable, for an event to be considered reportable.
Statutory Definitions of Reportable Events
Serious Event: An event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient.
Incident: An event, occurrence or situation involving the clinical care of a patient in a medical facility, which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient.
Pressure Injury Definition
The definition for pressure injuries used to develop the guidance is adopted from the National Pressure Ulcer Advisory Panel (NPUAP). The panel released an update on April 13, 2016, announcing changes in terminology from pressure ulcer to pressure injury and updating the stages of pressure injury.
A pressure injury is defined as localized damage to the skin or underlying soft tissue, or both, usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a result of intense or prolonged pressure, or both, or pressure in combination with shear. The tolerance of soft tissue for pressure and shear may also be affected by microclimate, nutrition, perfusion, comorbidities and condition of the soft tissue.
Final Guidance for Reporting Pressure Injuries
The Authority and Department achieved consensus on the following principles and decision tree for reporting pressure injury events. Some of these standards have been revised in response to feedback the Authority and the Department received during the public comment period. Descriptions of all comments received and responses to those comments are outlined in the next section.
1. Report all unanticipated pressure injuries, both those that are hospital-acquired and those that are present on admission and progress (worsen) during the hospitalization, as either Incidents or Serious Events.
a. Not reportable:
1) Deep tissue injuries present on admission
2) All pressure injuries present on admission that remain stable (that is, unchanged) or improve during hospitalization
b. Incidents:
1) All hospital-acquired pressure injuries that do not require additional health care services
2) All pressure injuries present on admission that progress during the hospitalization but do not require additional health care services
c. Serious Events:
1) All hospital-acquired pressure injuries that require additional health care services
2) All pressure injuries present on admission that progress or worsen during the hospitalization and require additional health care services
2. Report the deepest stage pressure injury when multiple pressure injuries are present.
Acute health care facilities should submit a single report that represents the deepest stage pressure injury for each patient with multiple pressure injuries, rather than submitting a report for each pressure injury.
3. Report changes (that is, worsening) in pressure injuries.
Whether a pressure injury was present on admission or was hospital-acquired, if the injury progresses or worsens during hospitalization, acute health care facilities should report a Serious Event or Incident based on the deepest stage of any pressure injuries that progress.
4. Report medical device-related pressure injuries as either Incidents or Serious Events.
Medical device-related pressure injuries may result from devices used for diagnostic or therapeutic purposes. The resultant pressure injury generally conforms to the pattern or shape of the device. These injuries should be staged using the staging system described by NPUAP and reported as either Incidents or Serious Events.
5. Report mucosal ulcers as Incidents or Serious Events.
Mucosal membrane pressure injuries are found on mucous membranes (for example, oral cavity and nares). These injuries cannot be staged in the same manner as other pressure injuries but should be reported as either Incidents or Serious Events.
Decision Tree for Reporting Pressure Injuries
The following decision tree is provided to support decision making for reporting pressure injuries that meet the statutory definitions of Incidents or Serious Events as defined under the MCARE Act
Decision Tree for Reporting Pressure Injuries
Responses to Comments on Draft Guidance on Reporting Standards
Fifteen organizations submitted comments or questions to the Authority in response to the Draft Guidance Document during the 30-day public comment period October 1 through October 30, 2016. Of the 15 comments received, 19 questions/suggestions were identified. Responses to these questions were drafted by the Authority and Department and follow. Note that the reporting guidelines should be used to help facilities implement patient safety reporting requirements in this Commonwealth. They are not intended to guide clinical diagnosis or treatment options.
1. The Authority received seven comments requesting clarification of additional health care services, including the meaning of ''first-aid care'' with respect to specific and nonspecific instances of pressure injuries.
Response: For reporting, additional health care services do not include services that could be provided by someone other than a licensed health care professional. Services that could be provided by someone other than a licensed health care practitioner outside the clinical setting—essentially, first-aid care—do not constitute additional health care services. The provision of professional services requires both knowledge and skill, and licensure ensures that the provision of some services is restricted to certain individuals who have demonstrated the required knowledge and skill. This definition encompasses a broad spectrum of services that should be individualized to each patient and each pressure injury. There is no ''one size fits all'' approach to defining the actual services that might be included in the definition. Each service provided by the facility must be evaluated independently against the definition to determine whether it meets the definition. For example, enzymatic debridement may be considered an additional health care service because it requires the prescription of a licensed health care professional. Repositioning, on the other hand, may be considered basic care that could be provided by someone other than a licensed health care professional. However, even repositioning could be considered an additional health care service when provided to a critically ill patient who cannot maintain oxygen saturation when repositioned on his left side and subsequently requires assessment by an experienced licensed professional to choose an alternative position.
2. The Authority received a single comment inquiring whether transferring to an outpatient service qualifies as additional health care services.
Response: Additional health care services constitute therapeutic care that can be provided only by a licensed professional health care worker. The facility is responsible for any services it provides, including any services provided on a contract basis. For example, if a patient is transferred to an outpatient wound clinic for services the hospital cannot provide during his admission, the facility is responsible for those services for which it has contracted and must evaluate those services for reporting requirements. Services, such as home care, that the patient receives outside of the admission to the reporter's facility would not be included in the determination of additional health care services. However, contracted services the facility is unable to provide directly during the patient's admission would be considered in this determination.
3. The Authority received a single comment inquiring whether changes in treatment from home care to acute care qualifies as additional health care services.
Response: If a patient has a pressure injury that is present on admission and that requires continued treatment in the acute care setting, this is not a reportable event if the pressure injury remains stable or improves. If the pressure injury progresses (that is, worsens) during hospitalization, the event is reportable, depending on whether additional health care services are required to treat the wound's progression.
4. The Authority received a single comment inquiring whether home care for dressing changes qualifies as additional health care services.
Response: Additional healthcare services are associated with an event, occurrence or situation involving the clinical care of a patient in a medical facility. Services such as home care, which the patient receives outside of a medical facility, would not be included in the determination of additional health care services. However, if the pressure injury is hospital-acquired, the event is reportable during the patient's hospital admission, depending on whether additional health care services are required to treat the injury. In the event the facility contracts with services outside the facility because it is unable to provide treatment of the pressure injury during the patient's admission, the contracted services would meet the definition of additional health care services.
5. The Authority received a single comment inquiring whether consultation with a WOCN or specialist for pressure injuries that are present on admission or hospital-acquired qualify as additional health care services.
Response: A wound care consultation in and of itself may not constitute additional health care services, because the services provided may not constitute additional health care services in all situations. Rather, the determination depends on the treatment recommended by the professional. For example, facilities may order consultations on all patients with low Braden scores,1 and this service would be considered preventive care rather than additional health care services.
6. The Authority received seven comments inquiring whether preventive care (for example, use of alternate bed surfaces and topical ointments) qualify as additional health care services. The Final Guidance for Acute Health care Facility Determinations of Reporting Requirements under MCARE Act indicates that health care services provided to prevent an injury are excluded from this term for the purpose of Serious Event determinations.
Response: Care provided to prevent injuries does not meet the Serious Event determination.
7. The Authority received a single comment inquiring whether pressure injuries that develop in patients who refuse preventive care are reportable.
Response: Although a health care professional is trained to know that some patients will have an increased risk of pressure injury development due to their clinical condition or refusal of interventions, this knowledge may not be anticipated by the patient, and event reporting in this Commonwealth does not depend on the patient's ability or willingness to participate in care. The unanticipated nature of an injury is from the perspective of a reasonably prudent patient, and an unanticipated injury requiring additional health care services would be reportable as a Serious Event. Complications and injuries from clinical care may be considered anticipated (that is, not reportable as a Serious Event) when they occur frequently or the risk of the complication is considered high for a particular patient and the high probability of this complication was: (1) disclosed to the patient or the patient's representative, or both; and (2) documented in the medical record, including the patient's understanding and the probable location of the pressure injury that is expected to develop if preventive measures are not implemented.
8. The Authority received a single comment expressing concern that individual patient risk factors and patient/family education provided before pressure-injury development are not taken into account in the draft guidance document.
Response: The guidance takes into account individual factors by requiring each patient, each pressure injury and each health care service to be evaluated to determine whether an event is reportable. The definition of additional health care services alone encompasses a broad spectrum of services that does not provide a ''one size fits all'' approach to defining the actual services that would be required for any single patient. Each service provided by the facility must be evaluated independently against the definition to determine whether it meets the definition. The unanticipated nature of an injury is from the perspective of a reasonably prudent patient, and an unanticipated injury requiring additional health care services would be reportable as a Serious Event.
9. The Authority received seven comments that requested clarification of reporting requirements for pressure injuries that are: (1) present on admission (that is, transferred to a hospital with existing pressure injuries) and progress during hospitalization; and (2) hospital-acquired that progress during hospitalization. These facilities contend that pressure injuries present on admission that do not arise from clinical care of the patient at the admitting facility do not meet the definition of a Serious Event.
Response: A pressure injury that is present on admission and remains stable throughout admission is not reportable. A pressure injury present on admission that progresses and involves the clinical care of a patient in a facility and results in a situation that could further injure the patient, requiring additional health care services, is reportable as either an Incident or Serious Event. The concepts of human error and preventability are not included in the Final Guidance for Acute Healthcare Facility Determinations of Reporting Requirements under MCARE Act. It is not necessary for an error to have occurred, or for harm to be preventable, for an event to be considered reportable. The requirement for reporting an event, situation or occurrence in this Commonwealth is based on the actual or potential injury to the patient, not the relationship of the actual or potential event to the facility's culpability. A pressure injury present on admission that worsens has a direct effect on the patient regardless of the role of the admitting facility. The progression (worsening) of a present-on-admission or a hospital-acquired pressure injury should be reported as an Incident or Serious Event because the worsening is an occurrence involving the clinical care of a patient in a facility. Although the worsening of the injury and the need for additional health care services may be anticipated by the provider, it may not be anticipated by the patient. The unanticipated nature of an injury is applied from the perspective of a reasonably prudent patient.
10. The Authority received a single comment requesting that the term ''worsening'' be clarified as it relates to pressure injuries reporting.
Response: Any skin changes in a patient should be evaluated by a licensed professional health care worker who possesses the required knowledge and skill to determine whether a pressure injury has changed for the worse. These changes will be individualized for each patient and each injury, and there is no ''one size fits all'' definition of worsening. Additionally, reporting in this Commonwealth is not based on the NPUAP staging system, so the worsening, or progression, of an injury will not necessarily be tied to the stage.
Although all of the individual situations that would require clinical judgement cannot be anticipated, an example might be a patient who is admitted with a stage 2 pressure injury that later progresses to stage 4 and requires mechanical debridement—this would be considered as worsening and is reportable as a Serious Event. Additionally, a stage 4 pressure injury present on admission that later becomes infected also demonstrates injury progression, or worsening, and is reportable.
11. The Authority received two comments expressing concern about reporting stage 2 pressure injuries as Serious Events and that these events are inconsistent with NPUAP, Centers for Medicare & Medicaid Services (CMS) and the Agency for Healthcare Research and Quality classifications. These comments suggest that Serious Events should be limited to full-thickness wounds that require interventions beyond a dressing.
Response: The requirement for reporting an event, situation or occurrence in this Commonwealth is based on the actual or potential injury to the patient. The pressure injury staging system developed by NPUAP is a clinical tool designed specifically for identifying and classifying pressure injuries according to the amount of tissue loss only. The NPUAP defines all stages as an injury. The reporting of any event, situation or occurrence involving the clinical care of a patient in this Commonwealth, including pressure injuries, is based on the event definitions provided in the MCARE Act, not on pressure injury stage. Therefore, pressure injury staging alone cannot be used to report patient safety events in this Commonwealth. The Commonwealth reporting requirements are internally consistent by treating pressure injuries like any other situation, event or occurrence requiring reporting. Patient safety event reporting in this Commonwealth was designed to be nonpunitive and does not include the concepts of preventability. Human error does not have to be present, and an injury does not have to be preventable, to meet the definitions of a reportable event.
Section 304(a)(7) of the MCARE Act (40 P.S. § 1303.304(a)(7) specifies that the Authority and the Department collect Serious Event and Incident reports to issue recommendations to medical facilities on a facility-specific or Statewide basis regarding changes, trends and improvements in health care practices and procedures, to reduce the number and severity of Serious Events and Incidents. Because patient safety reporting in this Commonwealth was designed to be nonpunitive, it may or may not align with the reporting requirements of other agencies, such as CMS. CMS has adopted the NPUAP staging system to classify preventable events for reimbursement and payment.
12. The Authority received five comments concerned about reporting deep tissue injury (DTI) present on admission and recommended exclusion from reporting.
Response: NPUAP defines a DTI as ''a pressure related injury to subcutaneous tissue under intact skin. . .these lesions may herald the subsequent development of a Stage III-IV pressure injury even with optimal treatment.'' A DTI present on admission is not reportable because the injury already existed even though it was invisible under intact skin. When the injury declares itself naturally, it is still considered ''stable'' because the injury was present but not visible. However, any changes to the injury after it declares itself, such as an infection or stage progression, would meet the definition of an Incident or Serious Event and is reportable.
Facilities are not required to report events that occurred in another health care setting, and staff who discover that an event occurred in another facility are strongly encouraged to notify the other facility. Although an injury may have originated in another facility, any situations, events or occurrences involving the clinical care of a patient while in the reporter's facility should be evaluated to determine whether it meets the definition of an Incident or Serious Event.
13. The Authority received six comments about reporting pressure injuries in critically or terminally ill patients (for example, use of medical devices required to sustain life and extracorporeal life support) and requested that these be excluded from reporting because most patients on life-saving devices are critically ill and compromised and are at higher risk for developing pressure injuries.
Response: The concept of preventability is not included in the Final Guidance for Acute Healthcare Facility Determinations of Reporting Requirements under MCARE Act. It is not necessary for harm or for the precise cause of an event to be known to constitute a reportable event. The requirement for reporting an event, situation or occurrence in this Commonwealth is based on the actual or potential injury to the patient, not the relationship of the actual or potential event to the facility's culpability. The event definitions for an Incident and Serious Event require the event, occurrence or situation to ''involve the clinical care of a patient'' not specifically to be caused by the clinical care provided by the facility. Although a health care professional is trained to know that a hemodynamically unstable or critically ill patient will have an increased risk of pressure injury development, this does not imply that the patient would anticipate the injury. The unanticipated nature of an injury is applied from the perspective of a reasonably prudent patient. An occurrence or situation does not have to include error or be preventable for an unanticipated injury to constitute a Serious Event. An unanticipated injury requiring additional health care services would not be excluded from reporting because a patient is actively dying. Any skin changes in a patient require evaluation by a licensed professional health care worker who possesses the required knowledge and skill to determine whether a skin change is a pressure injury. A pressure injury that develops in a dying patient may be an unanticipated injury from the patient's perspective and would require additional health care services, which is reportable as a Serious Event. Complications and injuries from clinical care may be considered anticipated (that is, not reportable as a Serious Event) when they occur frequently or the risk of the complication is considered high for a particular patient and the high probability of this complication was: (1) disclosed to the patient or the patient's representative, or both; and (2) documented in the medical record, including the patient's understanding and the probable location of the pressure injury that is expected to develop.
14. The Authority received a single comment suggesting that DTI and unstageable pressure injuries be excluded from reporting, because WOCNs or physicians are unable to stage pressure injuries until evidence presents more accurate staging of the injury.
Response: The reporting of any event, situation or occurrence involving the clinical care of a patient in this Commonwealth, including pressure injuries, is based on the event definitions provided in the MCARE Act, not on pressure injury staging. A DTI present on admission is not reportable because the injury has already occurred even though it may be invisible under intact skin. When the injury declares itself naturally, it is still considered ''stable'' because the injury was present but not visible. However, any changes to the injury after it declares itself, such as an infection or stage progression, would meet the definition of an Incident or Serious Event and is reportable. An unstageable pressure injury is full-thickness skin and tissue loss in which the extent of damage is not visible because the wound bed is obscured by slough or eschar. According to the pressure injury algorithm, an unstageable pressure injury present on admission would not be reportable if it remains stable or improves. An unstageable pressure injury that develops or progresses during admission is reportable as a Serious Event.
15. The Authority received a single comment suggesting mucosal injuries be excluded from reporting because WOCNs or physicians are unable to stage pressure injuries until evidence presents more accurate staging of the injury.
Response: The reporting of any event, situation or occurrence involving the clinical care of a patient in this Commonwealth, including pressure injuries, is based on the event definitions provided in the MCARE Act, not on pressure injury stage. Mucosal pressure injuries are found on mucous membranes with a history of a medical device in place at the location of the injury. A mucosal injury is an unanticipated injury from the patient's perspective and may require additional health care services, which would meet the definition of an Incident or Serious Event and is reportable.
16. The Authority received a single comment concerned that determining whether to report a pressure injury as a Serious Event or Incident would detract from care to prevent and heal wounds.
Response: The purpose of collecting reports is to analyze and disseminate the information to facilities to improve patient safety in this Commonwealth. Reporting pressure injuries in PA-PSRS provides data that the Authority can trend over time and helps hospitals assess the effectiveness of quality improvement efforts. A detailed analysis of pressure injuries is currently limited by a lack of information collected through PA-PSRS. This Final Guidance for Acute Health Care Facility Determinations of Reporting Requirements for Pressure Injuries is intended to address this issue. The Authority's patient safety liaisons can assist facilities' patient safety officers (section 309 of the MCARE Act (40 P.S. § 1303.309)) with reporting determinations.
17. The Authority received a single comment requesting clarification on reporting pressure injuries when patients with pressure injuries are received from other facilities. The Draft Guidance for Acute Health Care Facility Determinations of Reporting Requirements for Pressure Injuries is in direct conflict with the Final Guidance for Acute Healthcare Facility Determinations of Reporting Requirements under MCARE Act (that is, it is not necessary to report a Serious Events that occurred in another health care setting); it also conflicts with CMS' requirement and does not account for the NPUAP position. Submission of a letter (to the patient) may be perceived as suboptimal care and may increase malpractice risk.
Response: Following the pressure injury algorithm, a pressure injury present on admission would not be reportable if it remains stable or improves during the admission. Pressure injuries that are present on admission only become reportable if changes to the injury cause actual or potential injury to the patient, requiring additional health care services. These changes involve the clinical care of a patient and are reportable.
The intent of the MCARE Act is for nonpunitive patient safety reporting in this Commonwealth. Section 304(a)(7) of the MCARE Act specifies that the Authority and the Department collect Serious Event and Incident reports to issue recommendations to medical facilities on a facility-specific or Statewide basis regarding changes, trends and improvements in health care practices and procedures, to reduce the number and severity of Serious Events and Incidents. Punitive actions are written into section 313(f) of the MCARE Act (40 P.S. § 1303.313(f)) only for failure to report a Serious Event or Infrastructure Failure or failure to notify a patient of a Serious Event. Section 308(b) of the MCARE Act (40 P.S. § 1303.308(b)) specifically states that notifications to the patient of a Serious Event do not constitute an acknowledgment or admission of liability. Refer to response No. 11 about inconsistency of reporting.
18. The Authority received a single comment requesting clarification of when to report progression of the pressure injury (that is, at the time of discharge or at the time it is identified during hospitalization).
Response: The requirements for reporting an event are based on the actual or potential harm to the patient and not based on the pressure injury stage. The time frame for reporting an event depends on whether the event meets the definition of Incident or Serious Event. A Serious Event must be reported within 24 hours of confirmation. An Incident is reportable to the Authority within 90 days. A pressure injury identified as a Serious Event would be reported at the time it is identified and not held until discharge. The determination of whether a pressure injury is reportable as a Serious Event is not based on the stage of the injury alone.
19. The Authority received a single comment suggesting that facilities be given more than 24 hours for a wound care expert to determine whether a pressure injury meets the definition of a Serious Event.
Response: Any skin changes in a patient should be evaluated by a licensed professional health care worker who possesses the required knowledge and skill to determine whether a skin change is a pressure injury. A facility should use its usual process in the determination of Incidents or Serious Events. Serious Event reports must be submitted within 24 hours of confirmation. It is expected that confirmation should occur as close to the event as possible. Incident reports are received by the Authority and should be reported in a timely manner. The Authority's expectation is that all Incidents be reported within 90 days of occurrence.
REGINA M. HOFFMAN, RN, BSN, MBA, CPPS,
Executive Director
Patient Safety AuthorityKAREN M. MURPHY, PhD, RN,
Secretary
Department of Health
[Pa.B. Doc. No. 17-599. Filed for public inspection April 7, 2017, 9:00 a.m.] _______
1 The Braden Scale for Predicting Pressure Sore Risk®, http://www.bradenscale.com/, cited February 1, 2017.
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