1697 Draft guidance for acute healthcare facility determinations of reporting requirements for pressure injuries under the Medical Care Availability and Reduction of Error (MCARE) Act

PATIENT SAFETY AUTHORITY
DEPARTMENT OF HEALTH

Draft Guidance for Acute Healthcare Facility Determinations of Reporting Requirements for Pressure Injuries under the Medical Care Availability and Reduction of Error (MCARE) Act

[46 Pa.B. 6198]
[Saturday, October 1, 2016]

 This document outlines draft guidance to help acute healthcare facilities in this Commonwealth make determinations about whether occurrences of pressure injuries meet the statutory definitions of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 Health- System Association of Pennsylvania, the Healthcare Council of Western Pennsylvania, the Pennsylvania Ambulatory Surgery Association and the Healthcare 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), administration and facility operations, regulation, and patient safety and healthcare quality.

 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 healthcare 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.

 See the instructions for submitting comments at the end of this notice.

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 NPUAP released an update on April 13, 2016, announcing changes in terminology from pressure ulcer to pressure injury and updating the stages of pressure injury.

 Definition: 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 and/or prolonged pressure 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.

Principles for Reporting Pressure Injuries

 The Authority and the Department achieved consensus on the following principles and decision tree for reporting pressure injury events as follows: (1) not reportable; (2) reportable as Incidents; and (3) reportable as Serious Events.

 1. Report all hospital-acquired pressure injuries, and all pressure injuries present on admission that progress during the hospitalization, as either Incidents or Serious Events.

 a. Not reportable:

 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 healthcare services.

 2) All pressure injuries present on admission that progress during the hospitalization, but do not require additional healthcare services.

 c. Serious Events:

 1) All hospital-acquired pressure injuries that require additional healthcare services.

 2) All pressure injuries present on admission that did not initially require additional healthcare services that progressed (that is, worsened) during the hospitalization, and now require additional healthcare services.

 2. Report the deepest stage pressure injury when multiple pressure injuries are present.

 Acute healthcare 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 (that is, worsens) during hospitalization, acute healthcare facilities should report a Serious Event or Incident based on the deepest stage of any pressure injuries that progressed.

 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 the 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, 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.

 

Instructions for Submitting Comments

 Comments will be accepted for 30 days after the publication of this document. Comments may be submitted in writing to Patient Safety Authority, Attention: Bulletin Response, 333 Market Street, Lobby Level, Harrisburg, PA 17101, [e-mail], fax [phone], Attention: Bulletin Response.

 The Authority, the Department and the other members of the work group have a common goal of reviewing the public comments to this document, making selected changes in response to those comments and issuing a final guidance document to guide interpretations about whether occurrences of pressure injuries meet the statutory definitions of Incidents or Serious Events as defined under the MCARE Act.

 The Authority expects that final guidance will be published jointly by the Authority and the Department in the Pennsylvania Bulletin. Healthcare facilities may rely upon the final guidance as a standard to which they will be held by their Department surveyors. Final guidance will require approval from the Authority Board of Directors and the Secretary of the Department.

 Assuming the Authority and the Department approve the final guidance document, the agencies will need to modify the Pennsylvania Patient Safety Reporting System to support implementation of these standards and develop an education program for staff of both agencies as well as affected healthcare facilities. The final guidance document resulting from this process will include a timeline that accounts for these steps in implementation.

REGINA M. HOFFMAN, RN, BSN, MBA, CPPS, 
Executive Director
Patient Safety Authority

KAREN M. MURPHY, PhD, RN, 
Secretary
Department of Health

[Pa.B. Doc. No. 16-1697. Filed for public inspection September 30, 2016, 9:00 a.m.]