QA Investigation Results

Pennsylvania Department of Health
CHILDREN'S HOSPITAL OF PHILADELPHIA (THE)
Health Inspection Results
CHILDREN'S HOSPITAL OF PHILADELPHIA (THE)
Health Inspection Results For:


There are  12 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:

Based on the findings of an on site unannounced complaint investigation started on December 16, 2022 and completed on December 21, 2022, The Children's Hospital of Philadelphia End Stage Renal Dialysis Facility was found not to be in compliance with the following requirement of 42 CFR, Part 494.100, Subpart C, Conditions for Coverage - Care At Home. As a result of the survey, one (1) Condition level deficiency was cited, and resulted in Immediate Jeopardy. The Immediate Jeopardy was abated during the survey on December 21, 2022 at 10:13 AM.
















Plan of Correction:




494.100 CONDITION
CFC-CARE AT HOME

Name - Component - 00


Observations:

Based on a review of medical records (MR), facility policies and procedures, personnel files, interviews with the home hemodialysis training nurse, a review of a home health agency's documents, and an interview with a home health agency nurse, the facility failed to assure that personnel who are monitoring and managing the home hemodialysis treatments, and patient response to such treatments, are oriented and trained regarding the hemodialysis machine, patient monitoring, detecting, reporting and managing complications and measures to undertake should an emergency arise (V582 and V585), and failed to assure documentation of training for personnel who are providing home hemodialysis treatments (V586).

This condition was not met as evidenced by the above non-compliance and resulted in immediate jeopardy.

Immediate Jeopardy was identified on December 16 at 2:35 PM related to the above findings. The dialysis unit manager and home hemodialysis nurse were notified and preliminary findings were provided in writing at 2:45 PM.

A plan to remove the Immediate Jeopardy was received on December 19, 2022 at 1:16 PM. and rejected on December 19, 2022 at 2:34 PM.

Another plan to remove the Immediate Jeopardy was received on December 19, 2022 at 3:24 PM and accepted on December 19, 2022 at 3:29 PM.

The Immediate Jeopardy was abated during the survey on December 21, 2022 at 10:13 AM as evidenced by full implementation of the facility's plan to include the immediate removal of the untrained home health nurse who was providing care to the patient.








Plan of Correction:

Children's Hospital of Philadelphia (CHOP) provides extensive training to family members and identified care givers to operate and monitor the home hemodialysis machine. The training includes very specific instructions that only trained persons are permitted to operate the equipment. The home health agency nurse was not authorized by CHOP to operate this equipment as the nurse was not trained or competent to do so. The family did not disclose that this nurse was performing any of the monitoring of this equipment to the CHOP staff at the monthly office visits with the Nephrologist or any of the Dialysis team.
Immediately upon learning of the activities of the Licensed Practical Nurse (LPN) from Prestige Home Care Agency, CHOP's Medical Director for its Division of Nephrology spoke to the patient's mother. This occurred on December 16, 2022 at 4:30 pm. The Medical Director explained that the LPN must immediately cease activities involving the patient as the LPN had not been trained or demonstrated competence to use the patient's hemodialysis equipment. The Medical Director further explained that CHOP would contact Prestige to notify it of the LPN's activities, which had not been authorized by CHOP, and to require that the LPN removed from the care of the patient. The patient's mother agreed and stated she understood that the LPN would be discharged from care for her son.

CHOP's Nurse Manager for its Dialysis Unit called Prestige Home Care Agency on December 16, 2022 at 4:25pm and spoke to the Care Coordinator regarding the LPN's unauthorized activities. The Nurse Manager requested that the LPN be removed from caring for the patient immediately. Prestige's Care Coordinator stated that she would communicate this internally and a supervisor from Prestige would return a call to CHOP to learn more about the issues raised. The Nurse Manager confirmed that the LPN was removed in her follow up telephone call December 19, 2022 with the Care Coordinator. In addition, the Nurse Manager sent a letter to the Supervisor of Prestige on December 19,2022 requesting to remove the LPN from the care of this patient and to cease and desist the LPN from performing any dialysis activities .

The Medical Director will be responsible for monitoring the POC and ensuring caregivers clearly understand expectations at the conclusion of their training and at all followup visits.

Currently the home HD program only has one other patient and the Nurse Manager has confirmed with the caregiver that only the caregiver is providing and monitoring care on this equipment. The patient does not have external caregivers. The Nurse Manager spoke with the patient caregiver on 12-19-22.




494.100(a) STANDARD
H-IDT OVERSEES HOME TRAINING

Name - Component - 00
The interdisciplinary team must oversee training of the home dialysis patient, the designated caregiver, or self-dialysis patient before the initiation of home dialysis or self-dialysis (as defined in 494.10) and when the home dialysis caregiver or home dialysis modality changes.




Observations:

Based on a review of medical records (MR), facility policies and procedures, personnel files, interviews with the home hemodialysis training nurse, a review of a home health agency's documents, and an interview with a home health agency nurse, the facility failed to assure that personnel who are providing home hemodialysis service are appropriately trained. One (1) of one (1) MR did not meet the requirement (MR#1).

Findings include:

A review of medical record documents (MR#1) noted below was conducted on December 16, 2022 starting at approximatley 09:30 AM. The start of care for home hemodialysis for MR#1 was April 2, 2021.

A Review of MR#1 (Medical Record) included:

Home Dialysis Therapy Flowsheets from October 1, 2022 to December 14, 2022 encompassing fifty (50) treatments over the above time frame. The flowsheet consisted of a Pre-Dialysis Assessment, Treatment Section, and Post Dialysis Assessment. Some of the parameters monitored on the Treatment Section of the flowsheet include: blood pressure, pulse, ultrafiltration rate (UFR), blood flow rate (BFR), venous pressure, effluent pressure, arterial pressure, and comments/alarms. Over the above time frame, various types of alarms (documented as numbers) were recorded on the home HD flowsheet on 28 different days: 10/1, 10/2, 10/6, 10/9, 10/11, 10/15, 10/15, 10/17, 10/22, 10/24, 10/28, 10/30, 11/4, 11/5, 11/7, 11/8, 11/11, 11/13, 11/20, 11/23, 11/26, 11/29, 11/30, 12/3, 12/8, 12/9, 12/10, and 12/14, and interventions for the alarms, such as BFR decreased, UFR decreased, and/or fluid bolus administered, were recorded on 10/1, 10/2, 10/28, 10/30, 11/4, 11/5, 11/7, 11/23, 11/26, 11/30, 12/9, 12/10. The flowsheets did not contain a signature line nor any means of identifying the recorder/individual monitoring the home HD treatment.

Home HD Monthly Outpatient Visit Notes for 10/21/2022 and 11/18/2022 which contained documentation noting (under Psychosocial Section), "Any in home services (early intervention, home nursing, DME): Yes. Home nursing, 5 days per week during home hemodialysis."

A letter from the Division of Nephrology, dated November 18, 2022. It was unclear as to whom the letter was intended as the salutation was to "To Whom It May Concern." The letter stated, "Parent has received training which enables him/her to manage emergencies should they arise, and s/he will be present as s/he sets up the dialysis machine and connects and disconnects MR#1. However, having skilled nursing present to monitor MR#1' s dialysis will allow parent to take care of his/her other child and tend to household needs. We are requesting these skilled nursing services for a duration of 6 months." There is no further description in the letter as to the expections regarding monitoring of MR#1 by the home health nurse. MR#1 had been receiving skilled nursing services from the home health agency since 06/22/2021.

A review of documents from Prestige Home Care Agency, the home health agency that was providing skilled nursing services to MR#1, took place on December 15, 2022 from 1:00 PM to 2:00 PM and included the following:

Random Home Health Agency "Progress" (Nurses') notes for MR#1 for 10/4, 10/5, 10/8, 10/9, 10/14, 10/15, 10/16, 10/17, 10/24, 11/15, 11/16, 11/20, 11/22 and 11/23, written by the home health agency nurse, revealed that home health nurse was recording UFR, BFR, notations regarding arterial, venous, effluent pressures, and interventions such as decreasing BFR and UFR on the home health agency's progress note/procedure form and on the home health agency's nurses' notes. The above referenced notes were signed by the home health nurse and MR#1 's trained caregiver, who was MR#1's mother.

A review of home hemodialysis training records took place on December 16, 2022 from 1:45 PM to 2:00 PM.

The Training Records for the caregiver parent of MR#1 found that the training for home hemodialysis via the NxStage Cycler started on 03/11/2021 and ended on 04/03/2021. Training took place In-Center from 03/11/2021 to 03/30/2021, and was completed with 2 home observations on 04/02/2021, and 04/03/2021. There were no other training records provided nor documented for any other caregivers, including the home health agency nurse providing care to MR#1, located in the file.

A review of two (2) dialysis facility policies took place on December 16 2022 from 2:00 PM to 2:15 PM.

Dialysis Policy: Home Hemodialysis Training Criteria states, "Individualized home hemodialysis program that provides specialized training to the Care Partner in order to perform hemodialysis treatments in the home setting. Care Partner must meet all required competencies in order to deliver therapy independently in the home setting. Competencies ... ...trouble shooting alarms, managing medical complications. Documentation - document home hemodialysis regimen via written flowsheet and upload media to MYCHOP account. "Dialysis Procedure: Initiation of the CAR-125-B for Home Hemodialysis states " Home hemodialysis can be set up and performed only by trained staff or a family member that has met all requirements of the NxStage/CHOP training program. Launch and Monitor Treatment - performed by hemodialysis staff or trained family member." There was no evidence or documentation that the Home Health agency nurse had received training from the dialysis facility regarding the provision of home hemodialysis.

An interview was conducted with PF#1 on December 16, 2022 starting at 9:10 AM.

PF#1 stated that MR#1 was the first patient in the home hemodialysis (HD) program, starting in April 2021. Home HD Treatments for MR#1 are provided every day except Monday and Thursday, with a treatment duration of 3.5 to 4.0 hours. Once per month, MR#1 receives an incenter treatment. PF#1 is aware that MR#1 has a home health nurse. PF#1 states that the home health nurse monitors vital signs and documents "flows" on the flowsheet. PF#1 stated that the home health nurse is intended to support the trained caregiver (MR#1's mother), read "numbers" from the dialysis machine, and document for the trained caregiver (MR#1's mother). PF#1 stated that the trained caregiver (MR#1's mother) is to make all changes on the HD machine and respond to alarms when notified by the home health nurse. When reviewing the HD flowsheet, surveyor inquired as to how PF#1 knows that the trained caregiver (MR#1's mother) is actually making the changes since the HD flowsheet does not contain any signatures or initials. PF#1 stated that the format of the flowsheet does not allow for the identity of the individual making changes on the flowsheet due to absence of a signature.

An interview was conducted with the Prestige Home Care Agency home health nurse (PHHN), by an alternate surveyor, on December 9, 2022 at approximately 11:00 AM as part of a different complaint investigation associated with another facility. The PHHN is unaffiliated with the dialysis facility.

The PHHN stated that MR#1's trained caregiver (MR#!'s mother) sets up the hemodialysis machine and inputs the treatment goals. The PHHN stated that the trained caregiver (MR#1's mother) then proceeds to take care of another child while the PHHN is present during the home hemodialysis treatment. When the alternate surveyor asked the PHHN if s/he knew what the machine alarms are or what s/he does when the NxStage HD machine alarms, s/he stated that s/he refers to the NxStage manual. The PHHN stated that s/he does not notify the trained caregiver (MR#1's mother) about the alarms unless there is a major issue. The PHHN stated that s/he completes the home health agency's daily flowsheets and the dialysis facility's flowsheets. The PHHN stated that the dialysis facility is aware of the PHHN completing the HHD flowsheets, and that the dialysis facility is aware that home health nurse is the individual monitoring MR#1's care during treatment. PHHN stated that the home health agency does not have any dialysis training documentation from the dialysis facility. PHHN stated that the home hemodialysis training nurse will occasionally provide on the spot training to the trained caregiver and the PHHN, such as the new filter system. The PHHN stated that the trained caregiver is responsible for changing the HD machine's filter. The PHHN stated that these infrequent trainings are only documented in the PHHN's notes and s/he has no documentation from the home health agency or the dialysis facility regarding training. PHHN stated that s/he has been assigned as MR#1's home health nurse since June 2021. The PHHN stated that either s/he or the trained caregiver (MR#1's mother) will communicate any issues to the dialysis facility directly, and/or the PHHN will call NxStage directly for any HD machine issues. The alternate surveyor also reviewed the personnel file of the PHHN on 12/9/22 at 12:00 PM and found no documentation of dialysis training in PHHN's personnel file.

An interview with the dialysis unit manager and home hemodialysis training nurse on December 16, 2022. at 2:45 PM confirmed that the facility failed to assure that personnel who are providing home hemodialysis service are appropriately trained.











Plan of Correction:

CHOP was not aware that the PHHN was completing the CHOP HHD flowsheets as the documentation did not include initials or signature of the person documenting activities. CHOP updated the daily flowsheet where daily monitoring and vital signs are captured on December 16, 2022, to include initials and signature of the in-home care provider to ensure that CHOP can monitor that a trained caregiver is performing the monitoring. Additionally, CHOP's policy, "Home Hemodialysis Training Criteria" has been updated to reflect that caregiver must be trained regarding the potential danger of a non-trained person using the hemodialysis equipment, that such activities are prohibited by CHOP, and that noncompliance by patient families could result in the discontinuation of home hemodialysis. CHOP has updated its competency assessment document for in-home caregivers to expressly state that untrained caregivers are prohibited from using hemodialysis equipment.
CHOP does not have access to the PHHN Home Health Agency "Progress" (Nurses') notes.

New patients will be provided a newly created CHOP Home Hemodialysis Care Partner Agreement Checklist to sign prior to initiation of home dialysis which includes the statement "Only the CHOP trained care partner can manage machine therapy and patient access." In addition, at each follow-up visit to the Dialysis the caretaker will be reminded that only trained caregivers can manage the patient's therapy.

The letter from the Division of Nephrology, dated November 18, 2022, was requested by the mother to extend the homecare services for the patient and was intended to provide support for the family in providing respite services for the caregiver. The Medical Director acknowledges that the letter should have been more specific to the requested activities of the PHHN to clearly state that the PHHN was not permitted to operate the home hemodialysis equipment and that the PHHN is present during the home hemodialysis treatment to monitor the patient only and to request the trained caregiver to immediately respond to alarms and to make all changes on the HD machine when notified by the home health nurse.
All future requests for home care services for patients receiving HHD will include clear instructions and expectations of the PHHN role and will specifically state that the PHHN is not permitted to operate the home hemodialysis equipment.

The Medical Director will be responsible for monitoring the POC and ensuring caregivers clearly understand expectations at the conclusion of their training and at all follow-up visits.

Currently the home HD program only has one other patient and the Nurse Manager has confirmed with the caregiver that only the caregiver is providing and monitoring care on this equipment. The patient does not have external caregivers. The Nurse Manager spoke with the patient caregiver on 12-19-22.





494.100(a)(3) STANDARD
H-TRAIN CONTENT INCLUDES ER PREP HOME PTS

Name - Component - 00
The training must-
(3) Be conducted for each home dialysis patient and address the specific needs of the patient, in the following areas:
(i) The nature and management of ESRD.
(ii) The full range of techniques associated with the treatment modality selected, including effective use of dialysis supplies and equipment in achieving and delivering the physician's prescription of Kt/V or URR, and effective administration of erythropoiesis-stimulating agent(s) (if prescribed) to achieve and maintain a target level hemoglobin or hematocrit as written in patient's plan of care.
(iii) How to detect, report, and manage potential dialysis complications, including water treatment problems.
(iv) Availability of support resources and how to access and use resources.
(v) How to self-monitor health status and record and report health status information.
(vi) How to handle medical and non-medical emergencies.
(vii) Infection control precautions.
(viii) Proper waste storage and disposal procedures.





Observations:

Based on a review of medical records (MR), facility policies and procedures, personnel files, interviews with the home hemodialysis training nurse, a review of a home health agency's documents, and an interview with a home health agency nurse, the facility failed to assure that personnel who are monitoring and managing the home hemodialysis treatments, and patient response to such treatments, are oriented and trained regarding the hemodialysis machine, patient monitoring, detecting, reporting and managing complications, and measures to undertake should an emergency arise (V585).
One (1) of one (1) MR (MR#1) did not meet the requirement.

Findings include:

A review of medical record documents (MR#1) noted below was conducted on December 16, 2022 starting at approximatley 09:30 AM. The start of care for home hemodialysis for MR#1 was April 2, 2021.

A Review of MR#1 (Medical Record) included:

Home Dialysis Therapy Flowsheets from October 1, 2022 to December 14, 2022 encompassing fifty (50) treatments over the above time frame. The flowsheet consisted of a Pre-Dialysis Assessment, Treatment Section, and Post Dialysis Assessment. Some of the parameters monitored on the Treatment Section of the flowsheet include: blood pressure, pulse, ultrafiltration rate (UFR), blood flow rate (BFR), venous pressure, effluent pressure, arterial pressure, and comments/alarms. Over the above time frame, various types of alarms (documented as numbers) were recorded on the home HD flowsheet on 28 different days: 10/1, 10/2, 10/6, 10/9, 10/11, 10/15, 10/15, 10/17, 10/22, 10/24, 10/28, 10/30, 11/4, 11/5, 11/7, 11/8, 11/11, 11/13, 11/20, 11/23, 11/26, 11/29, 11/30, 12/3, 12/8, 12/9, 12/10, and 12/14, and interventions for the alarms, such as BFR decreased, UFR decreased, and/or fluid bolus administered, were recorded on 10/1, 10/2, 10/28, 10/30, 11/4, 11/5, 11/7, 11/23, 11/26, 11/30, 12/9, 12/10. The flowsheets did not contain a signature line nor any means of identifying the recorder/individual monitoring the home HD treatment.

Home HD Monthly Outpatient Visit Notes for 10/21/2022 and 11/18/2022 which contained documentation noting (under Psychosocial Section), "Any in home services (early intervention, home nursing, DME): Yes. Home nursing, 5 days per week during home hemodialysis."

A letter from the Division of Nephrology, dated November 18, 2022. It was unclear as to whom the letter was intended as the salutation was to "To Whom It May Concern." The letter stated, "Parent has received training which enables him/her to manage emergencies should they arise, and s/he will be present as s/he sets up the dialysis machine and connects and disconnects MR#1. However, having skilled nursing present to monitor MR#1' s dialysis will allow parent to take care of his/her other child and tend to household needs. We are requesting these skilled nursing services for a duration of 6 months." There is no further description in the letter as to the expections regarding monitoring of MR#1 by the home health nurse. MR#1 had been receiving skilled nursing services from the home health agency since 06/22/2021.

A review of documents from Prestige Home Care Agency, the home health agency that was providing skilled nursing services to MR#1, took place on December 15, 2022 from 1:00 PM to 2:00 PM and included the following:

A "To Whom It May Concern" letter written by MR#1's pediatrician stating, "due to MR#1's medical needs, the patient will require skilled nursing services 4-8 hours a day and 5 days a week. These days and hours will be interchangeable specific to the patient's needs."

The Home Health Certification and Plan of Care for Prestige Home Health Agency revealed that home health services/skilled nursing services were started on 06/22/2021 with the most recent re-certification period from 10/15/2022 to 12/13/2022. The services were ordered by MR#1's pediatrician.

Random Home Health Agency "Progress" (Nurses') notes for MR#1 for 10/4, 10/5, 10/8, 10/9, 10/14, 10/15, 10/16, 10/17, 10/24, 11/15, 11/16, 11/20, 11/22 and 11/23, written by the home health agency nurse, revealed that home health nurse was recording UFR, BFR, notations regarding arterial, venous, effluent pressures, and interventions such as decreasing BFR and UFR on the home health agency's progress note/procedure form and on the home health agency's nurses' notes. The above referenced notes were signed by the home health nurse and MR#1 's trained caregiver, who was MR#1's mother.

A review of two (2) dialysis facility policies took place on December 16 2022 from 2:00 PM to 2:15 PM.

Dialysis Policy: Home Hemodialysis Training Criteria states, "Individualized home hemodialysis program that provides specialized training to the Care Partner in order to perform hemodialysis treatments in the home setting. Care Partner must meet all required competencies in order to deliver therapy independently in the home setting. Competencies ... ...trouble shooting alarms, managing medical complications. Documentation - document home hemodialysis regimen via written flowsheet and upload media to MYCHOP account. "Dialysis Procedure: Initiation of the CAR-125-B for Home Hemodialysis states " Home hemodialysis can be set up and performed only by trained staff or a family member that has met all requirements of the NxStage/CHOP training program. Launch and Monitor Treatment - performed by hemodialysis staff or trained family member."

An interview was conducted with PF#1 on December 16, 2022 starting at 9:10 AM.

PF#1 stated that MR#1 was the first patient in the home hemodialysis (HD) program, starting in April 2021. Home HD Treatments for MR#1 are provided every day except Monday and Thursday, with a treatment duration of 3.5 to 4.0 hours. Once per month, MR#1 receives an incenter treatment. PF#1 is aware that MR#1 has a home health nurse. PF#1 states that the home health nurse monitors vital signs and documents "flows" on the flowsheet. PF#1 stated that the home health nurse is intended to support the trained caregiver (MR#1's mother), read "numbers" from the dialysis machine, and document for the trained caregiver (MR#1's mother). PF#1 stated that the trained caregiver (MR#1's mother) is to make all changes on the HD machine and respond to alarms when notified by the home health nurse. When reviewing the HD flowsheet, surveyor inquired as to how PF#1 knows that the trained caregiver (MR#1's mother) is actually making the changes since the HD flowsheet does not contain any signatures or initials. PF#1 stated that the format of the flowsheet does not allow for the identity of the individual making changes on the flowsheet due to absence of a signature.

An interview was conducted with the Prestige Home Care Agency home health nurse (PHHN), by an alternate surveyor, on December 9, 2022 at approximately 11:00 AM as part of a different complaint investigation associated with another facility. The PHHN is unaffiliated with the dialysis facility.

The PHHN stated that MR#1's trained caregiver (MR#!'s mother) sets up the hemodialysis machine and inputs the treatment goals. The PHHN stated that the trained caregiver (MR#1's mother) then proceeds to take care of another child while the PHHN is present during the home hemodialysis treatment. When the alternate surveyor asked the PHHN if s/he knew what the machine alarms are or what s/he does when the NxStage HD machine alarms, s/he stated that s/he refers to the NxStage manual. The PHHN stated that s/he does not notify the trained caregiver (MR#1's mother) about the alarms unless there is a major issue. The PHHN stated that s/he completes the home health agency's daily flowsheets and the dialysis facility's flowsheets. The PHHN stated that the dialysis facility is aware of the PHHN completing the HHD flowsheets, and that the dialysis facility is aware that home health nurse is the individual monitoring MR#1's care during treatment. PHHN stated that the home health agency does not have any dialysis training documentation from the dialysis facility. PHHN stated that the home hemodialysis training nurse will occasionally provide on the spot training to the trained caregiver and the PHHN, such as the new filter system. The PHHN stated that the trained caregiver is responsible for changing the HD machine's filter. The PHHN stated that these infrequent trainings are only documented in the PHHN's notes and s/he has no documentation from the home health agency or the dialysis facility regarding training. PHHN stated that s/he has been assigned as MR#1's home health nurse since June 2021. The PHHN stated that either s/he or the trained caregiver (MR#1's mother) will communicate any issues to the dialysis facility directly, and/or the PHHN will call NxStage directly for any HD machine issues. The alternate surveyor also reviewed the personnel file of the PHHN on 12/9/22 at 12:00 PM and found no documentation of dialysis training in PHHN's personnel file.

An interview with the dialysis unit manager and the home hemodialysis training nurse on December 16, 2022 at 2:45 PM confirmed that the that the dialysis facility failed to assure that personnel who are monitoring and managing the home hemodialysis treatments, and patient response to such treatments, are oriented and trained regarding the hemodialysis machine, patient monitoring, detecting, reporting and managing complications, and measures to undertake should an emergency arise.











Plan of Correction:

CHOP was not aware that the PHHN was completing the CHOP HHD flowsheets as the documentation did not include initials or signature of the person documenting activities. CHOP updated the daily flowsheet where daily monitoring and vital signs are captured on December 16, 2022 to include initials and signature of the in-home care provider to ensure that CHOP can monitor that a trained caregiver is performing the monitoring. Additionally, CHOP's policy, "Home Hemodialysis Training Criteria" has been updated to reflect that caregivers must be trained regarding the potential danger of a non-trained person using the hemodialysis equipment, that such activities are prohibited by CHOP, and that noncompliance by patient families could result in the discontinuation of home hemodialysis. CHOP has updated its competency assessment document for in-home caregivers to expressly state that untrained caregivers are prohibited from using hemodialysis equipment.
The letter from the Division of Nephrology, dated November 18, 2022 was requested by the mother to extend the homecare services for the patient and was intended to provide support for the family in providing respite services for the caregiver. The Medical Director acknowledges that the letter should have been more specific to the requested activities of the PHHN to clearly state that the PHHN was not permitted to operate the home hemodialysis equipment and that the PHHN is present during the home hemodialysis treatment to monitor the patient only and to request the trained caregiver to immediately respond to alarms and to make all changes on the HD machine when notified by the home health nurse.
All future requests for home care services for patients receiving HHD will include clear instructions and expectations of the PHHN role and will specifically state that the PHHN is not permitted to operate the home hemodialysis equipment.
New patients will be provided a newly created CHOP Home Hemodialysis Care Partner Agreement Checklist to sign prior to initiation of home dialysis which includes the statement "Only the CHOP trained care partner can manage machine therapy and patient access." In addition, at each follow-up visit to the Dialysis the caretaker will be reminded that only trained caregivers can manage the patient's therapy.

The Medical Director will be responsible for monitoring the POC and ensuring caregivers clearly understand expectations at the conclusion of their training and at all followup visits.

Currently the home HD program only has one other patient and the Nurse Manager has confirmed with the caregiver that only the caregiver is providing and monitoring care on this equipment. The patient does not have external caregivers. The Nurse Manager spoke with the patient caregiver on 12-19-22.





494.100(b)(1) STANDARD
H-PT/CAREGIVER DEMO COMPREHEND TRAINING

Name - Component - 00
The dialysis facility must -
(1) Document in the medical record that the patient, the caregiver, or both received and demonstrated adequate comprehension of the training;


Observations:

Based on a review of medical records (MR), facility policies and procedures, personnel files, interviews with the home hemodialysis training nurse, a review of a home health agency's documents, and an interview with a home health agency nurse, the facility failed to assure that personnel who are monitoring and managing the home hemodialysis treatments have documented training. One (1) of one (1) MR did not meet the requirement (MR#1).

Findings Include:

A review of medical record documents (MR#1) noted below was conducted on December 16, 2022 starting at approximatley 09:30 AM. The start of care for home hemodialysis for MR#1 was April 2, 2021.

A Review of MR#1 (Medical Record) included:

Home Dialysis Therapy Flowsheets from October 1, 2022 to December 14, 2022 encompassing fifty (50) treatments over the above time frame. The flowsheet consisted of a Pre-Dialysis Assessment, Treatment Section, and Post Dialysis Assessment. Some of the parameters monitored on the Treatment Section of the flowsheet include: blood pressure, pulse, ultrafiltration rate (UFR), blood flow rate (BFR), venous pressure, effluent pressure, arterial pressure, and comments/alarms. Over the above time frame, various types of alarms (documented as numbers) were recorded on the home HD flowsheet on 28 different days: 10/1, 10/2, 10/6, 10/9, 10/11, 10/15, 10/15, 10/17, 10/22, 10/24, 10/28, 10/30, 11/4, 11/5, 11/7, 11/8, 11/11, 11/13, 11/20, 11/23, 11/26, 11/29, 11/30, 12/3, 12/8, 12/9, 12/10, and 12/14, and interventions for the alarms, such as BFR decreased, UFR decreased, and/or fluid bolus administered, were recorded on 10/1, 10/2, 10/28, 10/30, 11/4, 11/5, 11/7, 11/23, 11/26, 11/30, 12/9, 12/10. The flowsheets did not contain a signature line nor any means of identifying the recorder/individual monitoring the home HD treatment.

A letter from the Division of Nephrology, dated November 18, 2022. It was unclear as to whom the letter was intended as the salutation was to "To Whom It May Concern." The letter stated, "Parent has received training which enables him/her to manage emergencies should they arise, and s/he will be present as s/he sets up the dialysis machine and connects and disconnects MR#1. However, having skilled nursing present to monitor MR#1' s dialysis will allow parent to take care of his/her other child and tend to household needs. We are requesting these skilled nursing services for a duration of 6 months." There is no further description in the letter as to the expections regarding monitoring of MR#1 by the home health nurse. MR#1 had been receiving skilled nursing services from the home health agency since 06/22/2021.

A review of documents from Prestige Home Care Agency, the home health agency that was providing skilled nursing services to MR#1, took place on December 15, 2022 from 1:00 PM to 2:00 PM and included the following:

Random Home Health Agency "Progress" (Nurses') notes for MR#1 for 10/4, 10/5, 10/8, 10/9, 10/14, 10/15, 10/16, 10/17, 10/24, 11/15, 11/16, 11/20, 11/22 and 11/23, written by the home health agency nurse, revealed that home health nurse was recording UFR, BFR, notations regarding arterial, venous, effluent pressures, and interventions such as decreasing BFR and UFR on the home health agency's progress note/procedure form and on the home health agency's nurses' notes. The above referenced notes were signed by the home health nurse and MR#1 's trained caregiver, who was MR#1's mother.

A review of two (2) dialysis facility policies took place on December 16 2022 from 2:00 PM to 2:15 PM.

Dialysis Policy: Home Hemodialysis Training Criteria states, "Individualized home hemodialysis program that provides specialized training to the Care Partner in order to perform hemodialysis treatments in the home setting. Care Partner must meet all required competencies in order to deliver therapy independently in the home setting. Competencies ... ...trouble shooting alarms, managing medical complications. Documentation - document home hemodialysis regimen via written flowsheet and upload media to MYCHOP account. "Dialysis Procedure: Initiation of the CAR-125-B for Home Hemodialysis states " Home hemodialysis can be set up and performed only by trained staff or a family member that has met all requirements of the NxStage/CHOP training program. Launch and Monitor Treatment - performed by hemodialysis staff or trained family member." There was no evidence or documentation that the Home Health agency nurse had received training from the dialysis facility regarding the provision of home hemodialysis.

An interview was conducted with PF#1 on December 16, 2022 starting at 9:10 AM.

PF#1 stated that MR#1 was the first patient in the home hemodialysis (HD) program, starting in April 2021. Home HD Treatments for MR#1 are provided every day except Monday and Thursday, with a treatment duration of 3.5 to 4.0 hours. Once per month, MR#1 receives an incenter treatment. PF#1 is aware that MR#1 has a home health nurse. PF#1 states that the home health nurse monitors vital signs and documents "flows" on the flowsheet. PF#1 stated that the home health nurse is intended to support the trained caregiver (MR#1's mother), read "numbers" from the dialysis machine, and document for the trained caregiver (MR#1's mother). PF#1 stated that the trained caregiver (MR#1's mother) is to make all changes on the HD machine and respond to alarms when notified by the home health nurse. When reviewing the HD flowsheet, surveyor inquired as to how PF#1 knows that the trained caregiver (MR#1's mother) is actually making the changes since the HD flowsheet does not contain any signatures or initials. PF#1 stated that the format of the flowsheet does not allow for the identity of the individual making changes on the flowsheet due to absence of a signature.

An interview was conducted with the Prestige Home Care Agency home health nurse (PHHN), by an alternate surveyor, on December 9, 2022 at approximately 11:00 AM as part of a different complaint investigation associated with another facility. The PHHN is unaffiliated with the dialysis facility.

The PHHN stated that MR#1's trained caregiver (MR#!'s mother) sets up the hemodialysis machine and inputs the treatment goals. The PHHN stated that the trained caregiver (MR#1's mother) then proceeds to take care of another child while the PHHN is present during the home hemodialysis treatment. When the alternate surveyor asked the PHHN if s/he knew what the machine alarms are or what s/he does when the NxStage HD machine alarms, s/he stated that s/he refers to the NxStage manual. The PHHN stated that s/he does not notify the trained caregiver (MR#1's mother) about the alarms unless there is a major issue. The PHHN stated that s/he completes the home health agency's daily flowsheets and the dialysis facility's flowsheets. The PHHN stated that the dialysis facility is aware of the PHHN completing the HHD flowsheets, and that the dialysis facility is aware that home health nurse is the individual monitoring MR#1's care during treatment. PHHN stated that the home health agency does not have any dialysis training documentation from the dialysis facility. PHHN stated that the home hemodialysis training nurse will occasionally provide on the spot training to the trained caregiver and the PHHN, such as the new filter system. The PHHN stated that the trained caregiver is responsible for changing the HD machine's filter. The PHHN stated that these infrequent trainings are only documented in the PHHN's notes and s/he has no documentation from the home health agency or the dialysis facility regarding training. PHHN stated that s/he has been assigned as MR#1's home health nurse since June 2021. The PHHN stated that either s/he or the trained caregiver (MR#1's mother) will communicate any issues to the dialysis facility directly, and/or the PHHN will call NxStage directly for any HD machine issues. The alternate surveyor also reviewed the personnel file of the PHHN on 12/9/22 at 12:00 PM and found no documentation of dialysis training in PHHN's personnel file.

An interview with the dialysis unit manager and home hemodialysis training nurse on December 16, 2022. at 2:45 PM confirmed that the facility failed to assure that personnel who are monitoring and managing the home hemodialysis treatments have documented training.










Plan of Correction:

CHOP was not aware that the PHHN was completing the CHOP HHD flowsheets as the documentation did not include initials or signature of the person documenting activities. CHOP updated the daily flowsheet where daily monitoring and vital signs are captured on December 16, 2022 to include initials and signature of the in-home trained care provider to ensure that CHOP can monitor that a trained caregiver is performing the monitoring. Additionally, CHOP's policy, "Home Hemodialysis Training Criteria" has been updated to reflect those caregivers must be trained regarding the potential danger of a non-trained person using the hemodialysis equipment, that such activities are prohibited by CHOP, and that noncompliance by patient families could result in the discontinuation of home hemodialysis. CHOP has updated its competency assessment document for in-home caregivers to expressly state that untrained caregivers are prohibited from using hemodialysis equipment.
The letter from the Division of Nephrology, dated November 18, 2022 was requested by the mother to extend the homecare services for the patient and was intended to provide support for the family in providing respite services for the caregiver. The Medical Director acknowledges that the letter should have been more specific to the requested activities of the PHHN to clearly state that the PHHN was not permitted to operate the home hemodialysis equipment and that the PHHN is present during the home hemodialysis treatment to monitor the patient only and to request the trained caregiver to immediately respond to alarms and to make all changes on the HD machine when notified by the home health nurse.
All future requests for home care services for patients receiving HHD will include clear instructions and expectations of the PHHN role and will specifically state that the PHHN is not permitted to operate the home hemodialysis equipment.
New patients will be provided a newly created CHOP Home Hemodialysis Care Partner Agreement Checklist to sign prior to initiation of home dialysis which includes the statement "Only the CHOP trained care partner can manage machine therapy and patient access." In addition, at each follow-up visit to the Dialysis the caretaker will be reminded that only trained caregivers can manage the patient's therapy.

The Medical Director will be responsible for monitoring the POC and ensuring caregivers clearly understand expectations at the conclusion of their training and at all follow-up visits.

Currently the home HD program only has one other patient, and the Nurse Manager has confirmed with the caregiver that only the caregiver is providing and monitoring care on this equipment. The patient does not have external caregivers. The Nurse Manager spoke with the patient caregiver on 12-19-22.