Initial Comments:
Based on the findings of an onsite unannounced Pediatric Extended Care Center complaint investigation survey conducted March 27, 2025 and concluded off-site April 9, 2025, Aveanna Healthcare, was found not to be in compliance with the requirements of PA Act 54 of 1999, The Prescribed Pediatric Extended Care Centers Act, 35 P.S. , Section 449.61.
Plan of Correction:
REQUIREMENT
POLICIES AND PROCEDURES
Name - Component - 00
SECTION 15. Regulations. Requirements. (b)(12)
The director of the PECC shall assure that the governing body has developed, approved and implemented policies and procedures regarding the operation of the PECC. At a minimum, the PECC shall have policies and procedures on the prevention, reporting and investigation of abuse, delivery of medical and therapeutic services, control and delivery of pharmaceutical service and prevention of incidents and accidents.
Observations:
Based on review of the facility's policies /procedures and an interview with the Location Director (EMP# 1) and Clinical Manager (EMP #2), it was determined that the facility failed to ensure direct care clinical staff followed proper restraint policy and documentation for one (1) of one (1) medical record (MR # 1)
Findings include:
Review of Aveanna Healthcare Environment of care-safety: restraints on 3/31/25 at approximately 10: 00 AM revealed: " 1. There must be a trial of less restrictive measures unless the physical restraint is necessary to provide lifesaving treatment. 2. Restraints should be employed only in situations where patients may harm themselves or remove catheters and intravenous lines. 6. Protective devices should always be applied in a manner that maintains proper body alignment and ensures the patient ' s comfort. Mitts: Used to prevent the patient from injuring self with hands. Kling gauze may be wrapped around the patient ' s hands to serve as a mitt restraint. 1. Special precautions: A. Mitts should be removed at least every four (4) hours to permit skin care and allow patient to exercise fingers. Documentation: " Documentation shall include type of restraint, frequency of release, skin condition and care, and the absence of impairment of circulation and constriction or respiratory compromise with chest restraints. Responsibilities: The responsibilities each department has in connection with this policy/procedure: Directors and clinical supervisors: ensure compliance with policy, offer assistance with policy interpretation, and ensure staff are clinically competent. Clinical staff: ensure compliance and competency with policy and procedure. "
Review of Aveanna Healthcare Discipline of children in the Pediatric day healthcare center (PDHC) on 3/31/25 at approximately 10: 00 AM revealed: Overview: " It is the policy of the company to establish guidelines to be used by the staff in disciplining children enrolled in the PDHC program. It is the company ' s policy that all children will be treated with kindness, respect and acceptance. Discipline should be age focused and depend on the developmental level of the child. Discipline is about guiding children in ways that support their development of self-control. Effective discipline enhances self-worth and self-esteem. Effective discipline is ongoing. It includes the way employees verbally respond to the child, the tone of voice we use, the way we treat the child and how employees respond to and interact with the child day to day. Punishment is hurtful. It focuses on the child rather than the act or behavior. Punishment does not teach alternative behavior and creates trust issues in the caregiver-child relationship. Process/Procedure: The following guidelines will be used in disciplining children in the PDHC program: The staff will be respectful of parental requests and cultural backgrounds when disciplining children. Parents will be given a parent information packet which outlines Aveanna ' s discipline philosophy during the preadmission conference. Physical punishment will never be used. Staff are not allowed to spank, hit or use any type of physical force when disciplining a child. Children are not allowed to be physically isolated in a dark room, closet or left in an unsupervised area as a means of discipline. The safety of all the children will be the main concern for the staff. "
Review of Aveanna Healthcare complaint and incident reporting in PDHC on 4/9/25 at 8:30 AM revealed: Overview: It is the policy of the PDHC to document and respond to all patient related incidents and complaints in a timely manner. Complaints and incidents should be handled in a professional manner and every effort made to bring a satisfactory resolution. All complaints and incidents must be reported immediately to a location administrator who has final responsibility for follow up, investigation, and resolution. " ; Process/procedure: " It is the responsibility of the organization and its employees to provide all patients and their legal guardians with the information needed to file a report. This may include the corporate contact for handling complaints ...It is the responsibility of all employees to document all patient related incidents and complaints that affect the health, safety, and welfare of the patient or employee and report those incidents/complaints to their supervisor immediately. It is the responsibility of the location management to comply with any state or federal law regarding the reporting of incidents or complaints to the appropriate agency. "
Review of MR # 1 on 3/27/25 between 1:30 PM-2:20 PM revealed:
Start of care (SOC): 3/17/25; Date of birth (DOB): 8/10/23; diagnosis: other reduction deformities of brain, congenital laryngomalacia, dependence on supplemental oxygen. Orders: continuous pulse ox monitoring, offer oral food or formula every three (3) hours.
Allegation described in complaint was that the child ' s hands were taped inside of her hoodie, the sleeves pulled down and taped shut and the child was crying while being fed by a caregiver.
Agency administrator and clinical manager both verbally acknowledged that this incident occurred, education was given to center staff about proper use of mitts but no documentation noted in MR # 1 to indicate that the event occurred, no written documentation that education was provided to center staff regarding the proper use of gloves/mitts to prevent the children from pulling at tubing and the Pennsylvania Department of Health Division of Home Health was not notified of this event occurring.
An interview conducted with agency administrator on 4/9/25 at approximately 9:40 AM confirmed the above findings.
Plan of Correction:E 0021 POLICIES AND PROCEDURES
SECTION 15. Regulations. Requirements. (b)(12)
1. The Pediatric Extended Care Center (PECC) will ensure staff members are knowledgeable of the restraint policies, procedures, and documentation requirements when restraints are used. Efforts will be made to utilize less restrictive care measures to prevent this patient from pulling oxygen tubing from their face while ensuring adequate, safe, effective delivery of oxygen. PECC Management discussed the concerns with the family and appropriately documented their complaint according to policy.
2. The PECC Management immediately confirmed that staff members were not applying restraints to any other child at the facility. Education will be provided to ensure staff members are knowledgeable of less restrictive measures to deliver safe care without the use of restraints. If restraints are utilized to prevent patient harm, staff members will follow documentation and notification requirements.
3. The PECC Management will ensure proper language is added to the Safety in the PDHC Policy for the use of loose hand coverings on infants and children. PECC Management will provide detailed training for all staff members on company policies and procedures regarding restraints, safety, and incident reporting. Staff members will be educated on the use of less restrictive care such as play activities and toys that utilize hands and provide positive distraction from tubes and medical equipment. Staff members will document understanding by signing a Training In-Service Documentation form.
4. To ensure compliance, PECC management will monitor Plan of Correction by observing each child during classroom rounds daily to ensure staff members are utilizing less restrictive measures or are implementing and documenting restraints according to policies and procedures.
5. WHO: Administrator and Director of Nursing
DATE: 04/30/2025
REQUIREMENT
UNUSUAL INCIDENT REPORTING
Name - Component - 00
SECTION 15. Regulations. Requirements. (b)(14)
The PECC shall report any unusual incidents immediately to the department. Unusual incidents include a death, abuse or suspected abuse, rape, transfer to a hospital as a result of injury or accident, child abduction or child released to wrong family, fire on the premises, a need to implement a disaster plan or receipt of a strike notice, medical errors resulting in injury or harm to the child or any knowledge of an unlicensed practice of a regulated profession.
Observations:
Based on review of center policies/procedures, documentation, medical records, and an interview with the administrator and clinical manager, the center failed to ensure one (1) of one (1) patient event was reported to the Pennsylvania Department of Health (PA DOH)/Division of Home Health. (MR # 1)
Findings include:
Review of Aveanna Healthcare complaint and incident reporting in PDHC on 4/9/25 at 8:30 AM revealed: Overview: It is the policy of the PDHC to document and respond to all patient related incidents and complaints in a timely manner. Complaints and incidents should be handled in a professional manner and every effort made to bring a satisfactory resolution. All complaints and incidents must be reported immediately to a location administrator who has final responsibility for follow up, investigation, and resolution. " ; Process/procedure: " It is the responsibility of the organization and its employees to provide all patients and their legal guardians with the information needed to file a report. This may include the corporate contact for handling complaints ...It is the responsibility of all employees to document all patient related incidents and complaints that affect the health, safety, and welfare of the patient or employee and report those incidents/complaints to their supervisor immediately. It is the responsibility of the location management to comply with any state or federal law regarding the reporting of incidents or complaints to the appropriate agency. "
Review of Aveanna Healthcare Environment of care-safety: restraints on 3/31/25 at approximately 10: 00 AM revealed: " 1. There must be a trial of less restrictive measures unless the physical restraint is necessary to provide lifesaving treatment. 2. Restraints should be employed only in situations where patients may harm themselves or remove catheters and intravenous lines. 6. Protective devices should always be applied in a manner that maintains proper body alignment and ensures the patient ' s comfort. Mitts: Used to prevent the patient from injuring self with hands. Kling gauze may be wrapped around the patient ' s hands to serve as a mitt restraint. 1. Special precautions: A. Mitts should be removed at least every four (4) hours to permit skin care and allow patient to exercise fingers. Documentation: " Documentation shall include type of restraint, frequency of release, skin condition and care, and the absence of impairment of circulation and constriction or respiratory compromise with chest restraints. Responsibilities: The responsibilities each department has in connection with this policy/procedure: Directors and clinical supervisors: ensure compliance with policy, offer assistance with policy interpretation, and ensure staff are clinically competent. Clinical staff: ensure compliance and competency with policy and procedure. "
Review of Aveanna Healthcare Discipline of children in the Pediatric day healthcare center (PDHC) on 3/31/25 at approximately 10: 00 AM revealed: Overview: " It is the policy of the company to establish guidelines to be used by the staff in disciplining children enrolled in the PDHC program. It is the company ' s policy that all children will be treated with kindness, respect and acceptance. Discipline should be age focused and depend on the developmental level of the child. Discipline is about guiding children in ways that support their development of self-control. Effective discipline enhances self-worth and self-esteem. Effective discipline is ongoing. It includes the way employees verbally respond to the child, the tone of voice we use, the way we treat the child and how employees respond to and interact with the child day to day. Punishment is hurtful. It focuses on the child rather than the act or behavior. Punishment does not teach alternative behavior and creates trust issues in the caregiver-child relationship. Process/Procedure: The following guidelines will be used in disciplining children in the PDHC program: The staff will be respectful of parental requests and cultural backgrounds when disciplining children. Parents will be given a parent information packet which outlines Aveanna ' s discipline philosophy during the preadmission conference. Physical punishment will never be used. Staff are not allowed to spank, hit or use any type of physical force when disciplining a child. Children are not allowed to be physically isolated in a dark room, closet or left in an unsupervised area as a means of discipline. The safety of all the children will be the main concern for the staff. "
Review of MR # 1 on 3/27/25 between 1:30 PM-2:20 PM revealed:
Start of care (SOC): 3/17/25; Date of birth (DOB): 8/10/23; diagnosis: other reduction deformities of brain, congenital laryngomalacia, dependence on supplemental oxygen. Orders: continuous pulse ox monitoring, offer oral food or formula every three (3) hours.
Allegation described in complaint was that the child ' s hands were taped inside of her hoodie, the sleeves pulled down and taped shut and the child was crying while being fed by a caregiver.
Agency administrator and clinical manager both verbally acknowledged that this occurred, education was given to center staff about proper use of mitts but no documentation noted in MR # 1 to indicate that the event occurred, no written documentation that education was provided to center staff regarding the proper use of gloves/mitts to prevent the children from pulling at tubing and the Pennsylvania Department of Health Division of Home Health was not notified of this event occurring.
An interview conducted with agency administrator on 4/9/25 at approximately 9:40 AM confirmed the above findings.
Plan of Correction:E 0023 UNUSUAL INCIDENT REPORTING
SECTION 15. Regulations. Requirements. (b)(14)
1. The PECC discussed the family's concerns with the method of restraint used to prevent the patient from removing the oxygen tubing from her face. The concerns were documented on the appropriate complaint form. PECC Management and staff members now understand the importance of promptly documenting the use of restraints in the clinical record, documenting complaints and investigations, and notifying PA DOH timely.
2. PECC Management will follow the Complaint and Incident Reporting in the PDHC Policy when a complaint is reported. If the nature of the complaint requires notification to PA DOH, PECC Management will send timely documentation.
3. PECC Management will provide detailed training for all staff members on company policies and procedures regarding restraints, safety, and incident reporting. Staff members will document understanding by signing a Training In-Service Documentation form.
4. To ensure compliance, PECC management will document all complaints and incidents on an Occurrence Log and review documentation to ensure investigations were complete, resolutions were met if possible, and PA DOH was notified if necessary. This process will be ongoing and documented as part of the quarterly Quality Assurance Performance Improvement (QAPI) report.
5. WHO: Administrator and Director of Nursing
DATE: 04/30/2025
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