Every finding on record at Prestige Home Care Agency

Based on the findings of an onsite unannounced complaint investigation survey conducted December 8, 2022, and December 12, 2022, and concluded offsite on December 13, 2022, Prestige Home Care Agency, was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies. The investigation resulted in the identification one (1) condition level and four (4) standard level deficiencies.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on review of agency policy, clinical record (CR) reviews, and interview with agency staff, the agency failed to obtain a physician's signature on the Home Health Certification and Plan of Care (POC) in accordance with agency policy for three (3) of three (3) CR reviewed. (CR #1, 2, & 3) and the agency failed to ensure all services the patient receives are listed on the Home Health Certification and Plan of Care for one (1) of three (3) CR reviewed. (CR #3). Findings include: On 12/10/22 at approximately 10:00AM review of policies and job descriptions revealed the following: Review of agency policy "HCFA Plan of Care Certification" on 12/12/22, at approximately 10:00 AM states, "Prestige will attempt to contact and communicate with a physician should the plan of care not be signed and returned to the agency within seven (7) days of a verbal order. For all orders not containing physician counter signature within seven (7) days will exercise due diligence with clarifying follow-up in order to obtain the counter signature...All plans of care are to be reviewed at least every sixty (60) days..." Policy titled "Plan of Care" stated, "In developing the plan of care the following will occur: The patient's plan of care will be developed and discussed with the RN supervisor. This will cover...type of services and equipment required...medications and treatments...and any other appropriate items...All supervisory visits are performed at the patient's residence and a supervisory visit report is complete and signed...Drugs and treatments are administered by agency staff only as ordered by the physician." Job description for "Administrator" stated, "Responsibilities: ensure employment of qualified personnel" Job description for "Registered Nurse" stated, "Clinical Responsibilities: Communicate verbally with the physician and other health care team members regarding the client's needs or progress and obtain physician orders as needed in accordance with agency policies... Reevaluate the client's progress and revise/update the POC (Plan of Care) ..." Job description for "Licensed Practical Nurse" stated, "Main function: to provide nursing services in accordance with current applicable Federal, State and Local standards, guidelines and regulations, to assure that the highest degree of quality continuity of patient care can be maintained ...Clinical Responsibilities: assist physician and registered nurse in performing specialized procedure, prepare equipment and materials for treatments...ensure patient care coordinated with RN supervisor." Policy titled, "Staff Competency" stated, "Purpose: to appropriately assess the performance of all clinical staff members and ensure those serviced by Prestige receive the highest level of care... Procedure: Prestige maintains a skilled checklist for each job position...Upon hire all staff will complete the appropriate skills checklist for his or her position... after hire all staff will be subject to ongoing competency evaluation no less frequently than annually. In addition to standard annual competency, clinical supervision will be utilized when the staff is performing a new procedure for the first time, the staff is using a piece of equipment for the first time, the staff has shown or made known areas in which retraining is needed or in which he or she has little or no knowledge or lacks experience, the first time staff provides care in specialized area...A staff member is not considered competent in a skill until satisfactory level performance is met. Staff may not perform any task if which they are unsatisfactory in until he or she received training and has successfully completed a subsequent evaluation..." On 12/13/22 at approximately 11:00 AM review of Fresenius Kidney Care Website titled, "What is Home Hemodialysis" stated, "What do you need to succeed at Home Hemodialysis... anywhere from 4 to 6 weeks of training along with your care partner (a family member or friend) if you need one. If you have a care partner, he or she needs to be dependable- to commit to either participating in your home hemodialysis treatments or staying with you to monitor them." On 12/13/22 at approximately 11:15 AM review of "ESRD. Part 494. Conditions for Coverage for End-Stage Renal Disease Facilities Interpretive Guidance V582" states, "§494.10 Definitions, "Home dialysis" means dialysis performed at home by an ESRD patient or "caregiver" (also called a "helper") who has completed an appropriate course of training as described in §494.100(a) of this part.... 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. Home dialysis training must be provided, and the patient and/or helper verified as competent to perform home dialysis before they are allowed to function independently ..." Review of clinical records (CR) occurred on 12/8/22 from approximately 10:00 AM to 2:00 PM, 12/10/22 and 12/13/22 at approximately 9:00AM and revealed the following: CR #1: Start of Care (SOC): 6/28/21. File contained Home Health Certification and Plan of Care for certification period 10/21/22-12/19/22 that was signed by the ordering physician on 11/22/22 (32 days later), plan of care for the certification period 8/22/22-10/20/22 was signed by the ordering physician on 10/20/22 (59 days later), certification period 12/25/21-2/22/22 was signed by the ordering physician on 2/15/22 (59 days later). CR #2: Start of Care (SOC): 3/11/19. File contained Home Health Certification and Plan of Care for the following certification periods that have not been signed by the ordering physician: 10/21/22-12/19/22, 8/22/22-10/20/22, 6/23/22-8/21/22. CR #3: Start of Care (SOC): 6/22/21. File contained Home Health Certification and Plan of Care for certification period 10/15/22-12/13/22 that was signed by the ordering physician on 11/18/22 (34 days later), plan of care for certification period 8/18/22-10/14/22 was signed by the ordering physician on 10/28/22 (71 days later). The diagnoses include Chronic Kidney Disease Stage 5 (kidneys are failing or close to failing) and acquired absence of kidney. The "Home Health Certification and Plan of Care" for certification period 10/15/22 through 12/13/22 states skilled nursing is for "skilled observation and assessment of renal status...SN to provide skilled support while patient is on hemodialysis at home..." Skilled Nursing (SN) orders for one (1) supervisory visit per month for nine (9) weeks, and skilled nursing 4-8 hours per day for five (5) days per week for nine (9) weeks. Review of "Nurse Visit Notes" revealed the following notes by LPN (PF #1). Note dated 11/23/22 states, “Alarm #2/Yellow #3, decreased BFR (blood flow rate) to 190 for now.” Note dated 11/15/22 states “Alarm #21 resolved with ease, 2.5 heparin, 0.9 given at 4:30 PM via filter system on NxStage hemodialysis machine, 5:30 PM 0.3 ML heparin via filter line.” Note dated 11/16/22 states “Alarm #21, lowered UFR (ultrafiltration) 0.30, BFR to 190, alarm stopped…Alarm #11 x 2, Alarm 10 x 4, Alarm #22, #10, #22 lowered UFR 0.20, lowered BFR 170...” Review of RN re-assessment conducted on 10/14/22 stated, "Equipment used: Hemodialysis Machine. Notes: Patient continues with hemodialysis treatments, tolerating well ..." Review of RN re-assessment conducted on 8/12/22 stated, ""Equipment used: Hemodialysis Machine. Continues with hemodialysis treatments, tolerating treatments well..." Review of RN-LPN supervision documentation from 11/15/22, 10/14/22 and 9/16/22 stated, "services are delivered consistent with the plan of care and authorization, yes...patient's needs are met, yes" Letter from Nephologist (Kidney specialist physician) dated 11/18/22 states, “Mom has received training which enables her to manage emergencies should they arise, and she will be present as she sets up the dialysis machine and connects and disconnects CR #3. However, having skilled nursing present to monitor CR#3’s dialysis will allow Mom to take care of her other child…” Interview with LPN (PF#1) was conducted on 12/9/22 at approximately 11:00 AM and again at 11:30 AM pertaining to the care of CR#3. LPN stated that the patient’s mother is responsible for the patient’s dialysis. When asked specifics, LPN stated that the patient’s mother sets up the machine and inputs the treatment goals. She stated then the mother goes and takes care of another one of her children while the LPN is there. When asked if she knew what the machine alarm are, or what she does when the NxStage (dialysis machine) alarms, she stated she refers to the manual. She stated that she does not get the patient’s mother unless it is a major issue. She stated that she completes the agency’s daily flowsheets and the Dialysis unit’s flowsheets as well. She stated the dialysis unit is aware of the Home Health Nurse completing the flowsheets and that she is the one monitoring the patient’s care during treatment. She stated the agency does not have any dialysis training documentation from the dialysis unit. She stated the mother went through six weeks of training and that the home hemodialysis nurse will occasionally provide on the spot training to herself and the mother on things such as new filter system (LPN did state that the mother is the one who changes the machine filter). She stated these infrequent trainings are only documented in her own notes and nothing officially from prestige or the dialysis unit. She stated she has been the patient’s nurse since June 2021. She stated when she is not there the patient’s mother will complete the entire treatment. The nurse also stated that either she or the patient's mother will communicate any issues with Children's Hospital of Philadelphia (CHOP Dialysis) directly and or/she will call NxStage (dialysis machine) directly if any machine issues. CR#3’s Home Health Certification and Plan of cares from the above certification periods reviewed above did not specify who is responsible for the patient's home dialysis. The plan of care also did not specify that the patient is under care of a nephologist, including the dialysis orders. In addition, the plan of care did not define as per the nephrologist's letter dated 11/18/22 what "monitoring by the skilled nurse " involves during the patient's home dialysis treatment. The skilled nurse's role is not defined well as evidenced by the above nursing documentation and LPN interview. On 12/12/22 between the approximate times of 10:00 AM and 2:00PM, review of ten (10) personnel files revealed the following: PF#1- Date of Original Hire: 10/8/18. (LPN left agency from 6/21/19- 1/30/20 and then left agency again from 2/19/20-6/29/21) Resumed most recent hire on 6/30/21. File revealed no documented training, skilled checklist or competency related to the specialized nursing care required for individuals receiving home hemodialysis (CR #3). An interview with Administrator was conducted on 12/8/22 at approximately 10:00 AM and stated that PF#1 has not received any documented training from the dialysis facility and showed the surveyor that the care plan states they are only there to monitor vital signs during home hemodialysis treatment. Interview with the Alternate Director of Nursing was conducted on 12/8/22 at approximately 2:00 PM and stated that for CR#3- the nurse is there to monitor vital signs, and check if tolerating treatment and monitor hydration status. They stated that the patient’s mother starts and stops the treatment and was trained by the dialysis facility. They stated that they believed if their agency nurse had any issues that they would go to the patient's mother. The Alternate DON also stated she believed that their agency nurse (PF#1) was also filling out separate specific dialysis treatment records for the home hemodialysis unit as well. Interview with the Administrator on 12/12/22 at approximately 2:00 PM confirmed the above findings.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on review of home hemodialysis training best practice guidelines, agency job descriptions, agency policies, three (3) clinical records and ten (10) personnel files (PF), and based on interview with the Administrator (PF #9), Alternate Director of Nursing (PF #6) and Licensed Practical Nurse (PF #1), the administrator/clinical manager failed to ensure specialized training for use of Home Hemodialysis machine was completed prior to the assignment of LPN (PF#1) to provide skilled nursing (SN) care to or oversight of patient (CR#3) receiving Home Hemodialysis treatment during LPN assigned hours (G0952) and the clinical manager failed to provide oversight to ensure that patient needs are continually assessed (G0966) and assure the development, implementation and updates of the individualized plan of care (G0968) Cross Reference Tags: §484.105(b)(1)(iv): Ensure that HHA Employs Qualified Personnel (G0952) §484.105(c) (4) Standard: Clinical manager. (G0966) §484.105(c) (5) Standard: Clinical manager. (G0968)

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on review of home hemodialysis training best practice guidelines, agency job descriptions, agency policies, three (3) clinical records and ten (10) personnel files (PF), and based on interview with the Administrator (PF #9), Alternate Director of Nursing (PF #6) and Licensed Practical Nurse (PF #1), the administrator/clinical manager failed to ensure documentation of specialized training for use of Home Hemodialysis machine was in personnel file prior to the assignment of LPN (PF#1) to provide skilled nursing (SN) care to or oversight of patient (CR#3) receiving Home Hemodialysis treatment during LPN assigned hours for one (1) of three (3) clinical records reviewed (CR#3) and one (1) of ten (10) personnel files reviewed (PF #1). Findings include: On 12/10/22 at approximately 10:00AM review of policies and job descriptions revealed the following: Policy titled "Plan of Care" stated, "In developing the plan of care the following will occur: The patient's plan of care will be developed and discussed with the RN supervisor. This will cover...type of services and equipment required...medications and treatments...and any other appropriate items...All supervisory visits are performed at the patient's residence and a supervisory visit report is complete and signed...Drugs and treatments are administered by agency staff only as ordered by the physician." Job description for "Administrator" stated, "Responsibilities: ensure employment of qualified personnel" Job description for "Registered Nurse" stated, "Clinical Responsibilities: Communicate verbally with the physician and other health care team members regarding the client's needs or progress and obtain physician orders as needed in accordance with agency policies... Reevaluate the client's progress and revise/update the POC (Plan of Care) ..." Job description for "Licensed Practical Nurse" stated, "Main function: to provide nursing services in accordance with current applicable Federal, State and Local standards, guidelines and regulations, to assure that the highest degree of quality continuity of patient care can be maintained ...Clinical Responsibilities: assist physician and registered nurse in performing specialized procedure, prepare equipment and materials for treatments...ensure patient care coordinated with RN supervisor." Policy titled, "Staff Competency" stated, "Purpose: to appropriately assess the performance of all clinical staff members and ensure those serviced by Prestige receive the highest level of care... Procedure: Prestige maintains a skilled checklist for each job position...Upon hire all staff will complete the appropriate skills checklist for his or her position... after hire all staff will be subject to ongoing competency evaluation no less frequently than annually. In addition to standard annual competency, clinical supervision will be utilized when the staff is performing a new procedure for the first time, the staff is using a piece of equipment for the first time, the staff has shown or made known areas in which retraining is needed or in which he or she has little or no knowledge or lacks experience, the first time staff provides care in specialized area...A staff member is not considered competent in a skill until satisfactory level performance is met. Staff may not perform any task if which they are unsatisfactory in until he or she received training and has successfully completed a subsequent evaluation..." On 12/13/22 at approximately 11:00 AM review of Fresenius Kidney Care Website titled, "What is Home Hemodialysis" stated, "What do you need to succeed at Home Hemodialysis... anywhere from 4 to 6 weeks of training along with your care partner (a family member or friend) if you need one. If you have a care partner, he or she needs to be dependable- to commit to either participating in your home hemodialysis treatments or staying with you to monitor them." On 12/13/22 at approximately 11:15 AM review of "ESRD. Part 494. Conditions for Coverage for End-Stage Renal Disease Facilities Interpretive Guidance V582" states, "§494.10 Definitions, "Home dialysis" means dialysis performed at home by an ESRD patient or "caregiver" (also called a "helper") who has completed an appropriate course of training as described in §494.100(a) of this part.... 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. Home dialysis training must be provided, and the patient and/or helper verified as competent to perform home dialysis before they are allowed to function independently ..." Review of clinical records (CR) occurred on 12/8/22 from approximately 10:00 AM to 2:00 PM, 12/10/22 and 12/13/22 at approximately 9:00AM and revealed the following: CR #3: the start of care date was 6/22/21, the patient/client is a minor. The diagnoses include Chronic Kidney Disease Stage 5 (kidneys are failing or close to failing) and acquired absence of kidney. The "Home Health Certification and Plan of Care" for certification period 10/15/22 through 12/13/22 states skilled nursing is for "skilled observation and assessment of renal status...SN to provide skilled support while patient is on hemodialysis at home..." Skilled Nursing (SN) orders for one (1) supervisory visit per month for nine (9) weeks, and skilled nursing 4-8 hours per day for five (5) days per week for nine (9) weeks. Review of "Nurse Visit Notes" revealed the following notes by LPN (PF #1). Note dated 11/23/22 states, “Alarm #2/Yellow #3, decreased BFR (blood flow rate) to 190 for now.” Note dated 11/15/22 states “Alarm #21 resolved with ease, 2.5 heparin, 0.9 given at 4:30 PM via filter system on NxStage hemodialysis machine, 5:30 PM 0.3 ML heparin via filter line.” Note dated 11/16/22 states “Alarm #21, lowered UFR (ultrafiltration) 0.30, BFR to 190, alarm stopped…Alarm #11 x 2, Alarm 10 x 4, Alarm #22, #10, #22 lowered UFR 0.20, lowered BFR 170...” Letter from Nephologist (Kidney specialist physician) dated 11/18/22 states, “Mom has received training which enables her to manage emergencies should they arise, and she will be present as she sets up the dialysis machine and connects and disconnects CR #3. However, having skilled nursing present to monitor CR#3’s dialysis will allow Mom to take care of her other child…” On 12/12/22 between the approximate times of 10:00 AM and 2:00PM, review of ten (10) personnel files revealed the following: PF#1- Date of Original Hire: 10/8/18. (LPN left agency from 6/21/19- 1/30/20 and then left agency again from 2/19/20-6/29/21) Resumed most recent hire on 6/30/21. File revealed no documented training, skilled checklist or competency related to the specialized nursing care required for individuals receiving home hemodialysis (CR #3). An interview with Administrator was conducted on 12/8/22 at approximately 10:00 AM and stated that PF#1 has not received any documented training from the dialysis facility and showed the surveyor that the care plan states they are only there to monitor vital signs during home hemodialysis treatment. Interview with the Alternate Director of Nursing was conducted on 12/8/22 at approximately 2:00 PM and stated that for CR#3- the nurse is there to monitor vital signs, and check if tolerating treatment and monitor hydration status. They stated that the patient’s mother starts and stops the treatment and was trained by the dialysis facility. They stated that they believed if their agency nurse had any issues that they would go to the patient's mother. The Alternate DON also stated she believed that their agency nurse (PF#1) was also filling out separate specific dialysis treatment records for the home hemodialysis unit as well. Interview with LPN (PF#1) was conducted on 12/9/22 at approximately 11:00 AM and again at 11:30 AM pertaining to the care of CR#3. LPN stated that the patient’s mother is responsible for the patient’s dialysis. When asked specifics, LPN stated that the patient’s mother sets up the machine and inputs the treatment goals. She stated then the mother goes and takes care of another one of her children while the LPN is there. When asked if she knew what the machine alarm are, or what she does when the NxStage (dialysis machine) alarms, she stated she refers to the manual. She stated that she does not get the patient’s mother unless it is a major issue. She stated that she completes the agency’s daily flowsheets and the Dialysis unit’s flowsheets as well. She stated the dialysis unit is aware of the Home Health Nurse completing the flowsheets and that she is the one monitoring the patient’s care during treatment. She stated the agency does not have any dialysis training documentation from the dialysis unit. She stated the mother went through six weeks of training and that the home hemodialysis nurse will occasionally provide on the spot training to herself and the mother on things such as new filter system (LPN did state that the mother is the one who changes the machine filter). She stated these infrequent trainings are only documented in her own notes and nothing officially from prestige or the dialysis unit. She stated she has been the patient’s nurse since June 2021. She stated when she is not there the patient’s mother will complete the entire treatment. The nurse also stated that either she or the patient's mother will communicate any issues with Children's Hospital of Philadelphia (CHOP Dialysis) directly and or/she will call NxStage (dialysis machine) directly if any machine issues. Interview with the Administrator on 12/12/22 at approximately 2:00 PM confirmed the above findings.

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on review of home hemodialysis training best practice guidelines, agency job descriptions, agency policies, three (3) clinical records and ten (10) personnel files (PF), and based on interview with the Administrator (PF #9), Alternate Director of Nursing (PF #6) and Licensed Practical Nurse (PF #1), the administrator/clinical manager failed to recognize the patient's needs were not being met by LPN without dialysis training documentation for one (1) of three (3) clinical records reviewed (CR#3) and one (1) of ten (10) personnel files reviewed (PF #1). Findings include: On 12/10/22 at approximately 10:00AM review of policies and job descriptions revealed the following: Policy titled "Plan of Care" stated, "In developing the plan of care the following will occur: The patient's plan of care will be developed and discussed with the RN supervisor. This will cover...type of services and equipment required...medications and treatments...and any other appropriate items...All supervisory visits are performed at the patient's residence and a supervisory visit report is complete and signed...Drugs and treatments are administered by agency staff only as ordered by the physician." Job description for "Administrator" stated, "Responsibilities: ensure employment of qualified personnel" Job description for "Registered Nurse" stated, "Clinical Responsibilities: Communicate verbally with the physician and other health care team members regarding the client's needs or progress and obtain physician orders as needed in accordance with agency policies... Reevaluate the client's progress and revise/update the POC (Plan of Care) ..." Job description for "Licensed Practical Nurse" stated, "Main function: to provide nursing services in accordance with current applicable Federal, State and Local standards, guidelines and regulations, to assure that the highest degree of quality continuity of patient care can be maintained ...Clinical Responsibilities: assist physician and registered nurse in performing specialized procedure, prepare equipment and materials for treatments...ensure patient care coordinated with RN supervisor." Policy titled, "Staff Competency" stated, "Purpose: to appropriately assess the performance of all clinical staff members and ensure those serviced by Prestige receive the highest level of care... Procedure: Prestige maintains a skilled checklist for each job position...Upon hire all staff will complete the appropriate skills checklist for his or her position... after hire all staff will be subject to ongoing competency evaluation no less frequently than annually. In addition to standard annual competency, clinical supervision will be utilized when the staff is performing a new procedure for the first time, the staff is using a piece of equipment for the first time, the staff has shown or made known areas in which retraining is needed or in which he or she has little or no knowledge or lacks experience, the first time staff provides care in specialized area...A staff member is not considered competent in a skill until satisfactory level performance is met. Staff may not perform any task if which they are unsatisfactory in until he or she received training and has successfully completed a subsequent evaluation..." On 12/13/22 at approximately 11:00 AM review of Fresenius Kidney Care Website titled, "What is Home Hemodialysis" stated, "What do you need to succeed at Home Hemodialysis... anywhere from 4 to 6 weeks of training along with your care partner (a family member or friend) if you need one. If you have a care partner, he or she needs to be dependable- to commit to either participating in your home hemodialysis treatments or staying with you to monitor them." On 12/13/22 at approximately 11:15 AM review of "ESRD. Part 494. Conditions for Coverage for End-Stage Renal Disease Facilities Interpretive Guidance V582 " states, "§494.10 Definitions, "Home dialysis" means dialysis performed at home by an ESRD patient or "caregiver" (also called a "helper") who has completed an appropriate course of training as described in §494.100(a) of this part.... 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. Home dialysis training must be provided, and the patient and/or helper verified as competent to perform home dialysis before they are allowed to function independently ..." Review of clinical records (CR) occurred on 12/8/22 from approximately 10:00 AM to 2:00 PM, 12/10/22 and 12/13/22 at approximately 9:00AM and revealed the following: CR #3: the start of care date was 6/22/21, the patient/client is a minor. The diagnoses include Chronic Kidney Disease Stage 5 (kidneys are failing or close to failing) and acquired absence of kidney. The "Home Health Certification and Plan of Care" for certification period 10/15/22 through 12/13/22 states skilled nursing is for "skilled observation and assessment of renal status...SN to provide skilled support while patient is on hemodialysis at home..." Skilled Nursing (SN) orders for one (1) supervisory visit per month for nine (9) weeks, and skilled nursing 4-8 hours per day for five (5) days per week for nine (9) weeks. Review of "Nurse Visit Notes" revealed the following notes by LPN (PF #1). Note dated 11/23/22 states, “Alarm #2/Yellow #3, decreased BFR (blood flow rate) to 190 for now.” Note dated 11/15/22 states “Alarm #21 resolved with ease, 2.5 heparin, 0.9 given at 4:30 PM via filter system on NxStage hemodialysis machine, 5:30 PM 0.3 ML heparin via filter line.” Note dated 11/16/22 states “Alarm #21, lowered UFR (ultrafiltration) 0.30, BFR to 190, alarm stopped…Alarm #11 x 2, Alarm 10 x 4, Alarm #22, #10, #22 lowered UFR 0.20, lowered BFR 170...” Review of RN re-assessment conducted on 10/14/22 stated, "Equipment used: Hemodialysis Machine. Notes: Patient continues with hemodialysis treatments, tolerating well ..." Review of RN re-assessment conducted on 8/12/22 stated, ""Equipment used: Hemodialysis Machine. Continues with hemodialysis treatments, tolerating treatments well..." Review of RN-LPN supervision documentation from 11/15/22, 10/14/22 and 9/16/22 stated, "services are delivered consistent with the plan of care and authorization, yes...patient's needs are met, yes" Letter from Nephologist (Kidney specialist physician) dated 11/18/22 states, “Mom has received training which enables her to manage emergencies should they arise, and she will be present as she sets up the dialysis machine and connects and disconnects CR #3. However, having skilled nursing present to monitor CR#3’s dialysis will allow Mom to take care of her other child…” CR#3’s Home Health Certification and Plan of cares from the above certification periods reviewed above did not specify who is responsible for the patient's home dialysis. The plan of care also did not specify that the patient is under care of a nephologist, including the dialysis orders. In addition, the plan of care did not define as per the nephrologist's letter dated 11/18/22 what "monitoring by the skilled nurse " involves during the patient's home dialysis treatment. The skilled nurse's role is not defined well as evidenced by the above nursing documentation and LPN interview. On 12/12/22 between the approximate times of 10:00 AM and 2:00PM, review of ten (10) personnel files revealed the following: PF#1- Date of Original Hire: 10/8/18. (LPN left agency from 6/21/19- 1/30/20 and then left agency again from 2/19/20-6/29/21) Resumed most recent hire on 6/30/21. File revealed no documented training, skilled checklist or competency related to the specialized nursing care required for individuals receiving home hemodialysis (CR #3). An interview with Administrator was conducted on 12/8/22 at approximately 10:00 AM and stated that PF#1 has not received any documented training from the dialysis facility and showed the surveyor that the care plan states they are only there to monitor vital signs during home hemodialysis treatment. Interview with the Alternate Director of Nursing was conducted on 12/8/22 at approximately 2:00 PM and stated that for CR#3- the nurse is there to monitor vital signs, and check if tolerating treatment and monitor hydration status. They stated that the patient’s mother starts and stops the treatment and was trained by the dialysis facility. They stated that they believed if their agency nurse had any issues that they would go to the patient's mother. The Alternate DON also stated she believed that their agency nurse (PF#1) was also filling out separate specific dialysis treatment records for the home hemodialysis unit as well. Interview with LPN (PF#1) was conducted on 12/9/22 at approximately 11:00 AM and again at 11:30 AM pertaining to the care of CR#3. LPN stated that the patient’s mother is responsible for the patient’s dialysis. When asked specifics, LPN stated that the patient’s mother sets up the machine and inputs the treatment goals. She stated then the mother goes and takes care of another one of her children while the LPN is there. When asked if she knew what the machine alarm are, or what she does when the NxStage (dialysis machine) alarms, she stated she refers to the manual. She stated that she does not get the patient’s mother unless it is a major issue. She stated that she completes the agency’s daily flowsheets and the Dialysis unit’s flowsheets as well. She stated the dialysis unit is aware of the Home Health Nurse completing the flowsheets and that she is the one monitoring the patient’s care during treatment. She stated the agency does not have any dialysis training documentation from the dialysis unit. She stated the mother went through six weeks of training and that the home hemodialysis nurse will occasionally provide on the spot training to herself and the mother on things such as new filter system (LPN did state that the mother is the one who changes the machine filter). She stated these infrequent trainings are only documented in her own notes and nothing officially from prestige or the dialysis unit. She stated she has been the patient’s nurse since June 2021. She stated when she is not there the patient’s mother will complete the entire treatment. The nurse also stated that either she or the patient's mother will communicate any issues with Children's Hospital of Philadelphia (CHOP Dialysis) directly and or/she will call NxStage (dialysis machine) directly if any machine issues. Interview with the Administrator on 12/12/22 at approximately 2:00 PM confirmed the above findings.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on review of home hemodialysis training best practice guidelines, agency job descriptions, agency policies, three (3) clinical records and ten (10) personnel files (PF), and based on interview with the Administrator (PF #9), Alternate Director of Nursing (PF #6) and Licensed Practical Nurse (PF #1), the clinical manager failed to the assure the plan of care accurately reflected the care provided by LPN (PF#1) for one (1) of three (3) clinical records reviewed (CR#3) and one (1) of ten (10) personnel files reviewed (PF #1). Findings include: On 12/10/22 at approximately 10:00AM review of policies and job descriptions revealed the following: Policy titled "Plan of Care" stated, "In developing the plan of care the following will occur: The patient's plan of care will be developed and discussed with the RN supervisor. This will cover...type of services and equipment required...medications and treatments...and any other appropriate items...All supervisory visits are performed at the patient's residence and a supervisory visit report is complete and signed...Drugs and treatments are administered by agency staff only as ordered by the physician." Job description for "Administrator" stated, "Responsibilities: ensure employment of qualified personnel" Job description for "Registered Nurse" stated, "Clinical Responsibilities: Communicate verbally with the physician and other health care team members regarding the client's needs or progress and obtain physician orders as needed in accordance with agency policies... Reevaluate the client's progress and revise/update the POC (Plan of Care) ..." Job description for "Licensed Practical Nurse" stated, "Main function: to provide nursing services in accordance with current applicable Federal, State and Local standards, guidelines and regulations, to assure that the highest degree of quality continuity of patient care can be maintained ...Clinical Responsibilities: assist physician and registered nurse in performing specialized procedure, prepare equipment and materials for treatments...ensure patient care coordinated with RN supervisor." Policy titled, "Staff Competency" stated, "Purpose: to appropriately assess the performance of all clinical staff members and ensure those serviced by Prestige receive the highest level of care... Procedure: Prestige maintains a skilled checklist for each job position...Upon hire all staff will complete the appropriate skills checklist for his or her position... after hire all staff will be subject to ongoing competency evaluation no less frequently than annually. In addition to standard annual competency, clinical supervision will be utilized when the staff is performing a new procedure for the first time, the staff is using a piece of equipment for the first time, the staff has shown or made known areas in which retraining is needed or in which he or she has little or no knowledge or lacks experience, the first time staff provides care in specialized area...A staff member is not considered competent in a skill until satisfactory level performance is met. Staff may not perform any task if which they are unsatisfactory in until he or she received training and has successfully completed a subsequent evaluation..." On 12/13/22 at approximately 11:00 AM review of Fresenius Kidney Care Website titled, "What is Home Hemodialysis" stated, "What do you need to succeed at Home Hemodialysis... anywhere from 4 to 6 weeks of training along with your care partner (a family member or friend) if you need one. If you have a care partner, he or she needs to be dependable- to commit to either participating in your home hemodialysis treatments or staying with you to monitor them." On 12/13/22 at approximately 11:15 AM review of "ESRD. Part 494. Conditions for Coverage for End-Stage Renal Disease Facilities Interpretive Guidance V582" states, "§494.10 Definitions, "Home dialysis" means dialysis performed at home by an ESRD patient or "caregiver" (also called a "helper") who has completed an appropriate course of training as described in §494.100(a) of this part.... 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. Home dialysis training must be provided, and the patient and/or helper verified as competent to perform home dialysis before they are allowed to function independently ..." Review of clinical records (CR) occurred on 12/8/22 from approximately 10:00 AM to 2:00 PM, 12/10/22 and 12/13/22 at approximately 9:00AM and revealed the following: CR #3: the start of care date was 6/22/21, the patient/client is a minor. The diagnoses include Chronic Kidney Disease Stage 5 (kidneys are failing or close to failing) and acquired absence of kidney. The "Home Health Certification and Plan of Care" for certification period 10/15/22 through 12/13/22 states skilled nursing is for "skilled observation and assessment of renal status...SN to provide skilled support while patient is on hemodialysis at home..." Skilled Nursing (SN) orders for one (1) supervisory visit per month for nine (9) weeks, and skilled nursing 4-8 hours per day for five (5) days per week for nine (9) weeks. Review of "Nurse Visit Notes" revealed the following notes by LPN (PF #1). Note dated 11/23/22 states, “Alarm #2/Yellow #3, decreased BFR (blood flow rate) to 190 for now.” Note dated 11/15/22 states “Alarm #21 resolved with ease, 2.5 heparin, 0.9 given at 4:30 PM via filter system on NxStage hemodialysis machine, 5:30 PM 0.3 ML heparin via filter line.” Note dated 11/16/22 states “Alarm #21, lowered UFR (ultrafiltration) 0.30, BFR to 190, alarm stopped…Alarm #11 x 2, Alarm 10 x 4, Alarm #22, #10, #22 lowered UFR 0.20, lowered BFR 170...” Review of RN re-assessment visit conducted on 10/14/22 stated, "Equipment used: Hemodialysis Machine. Notes: Patient continues with hemodialysis treatments, tolerating well ..." Review of RN re-assessment conducted on 8/12/22 stated, ""Equipment used: Hemodialysis Machine. Continues with hemodialysis treatments, tolerating treatments well..." Review of RN-LPN supervision documentation from 11/15/22, 10/14/22 and 9/16/22 stated, "services are delivered consistent with the plan of care and authorization, yes...patient's needs are met, yes" Letter from Nephologist (Kidney specialist physician) dated 11/18/22 states, “Mom has received training which enables her to manage emergencies should they arise, and she will be present as she sets up the dialysis machine and connects and disconnects CR #3. However, having skilled nursing present to monitor CR#3’s dialysis will allow Mom to take care of her other child…” CR#3’s Home Health Certification and Plan of cares from the above certification periods reviewed above did not specify who is responsible for the patient's home dialysis. The plan of care also did not specify that the patient is under care of a nephologist, including the dialysis orders. In addition, the plan of care did not define as per the nephrologist's letter dated 11/18/22 what "monitoring by the skilled nurse " involves during the patient's home dialysis treatment. The skilled nurse's role is not defined well as evidenced by the above nursing documentation and LPN interview. On 12/12/22 between the approximate times of 10:00 AM and 2:00PM, review of ten (10) personnel files revealed the following: PF#1- Date of Original Hire: 10/8/18. (LPN left agency from 6/21/19- 1/30/20 and then left agency again from 2/19/20-6/29/21) Resumed most recent hire on 6/30/21. File revealed no documented training, skilled checklist or competency related to the specialized nursing care required for individuals receiving home hemodialysis (CR #3). An interview with Administrator was conducted on 12/8/22 at approximately 10:00 AM and stated that PF#1 has not received any documented training from the dialysis facility and showed the surveyor that the care plan states they are only there to monitor vital signs during home hemodialysis treatment. Interview with the Alternate Director of Nursing was conducted on 12/8/22 at approximately 2:00 PM and stated that for CR#3- the nurse is there to monitor vital signs, and check if tolerating treatment and monitor hydration status. They stated that the patient’s mother starts and stops the treatment and was trained by the dialysis facility. They stated that they believed if their agency nurse had any issues that they would go to the patient's mother. The Alternate DON also stated she believed that their agency nurse (PF#1) was also filling out separate specific dialysis treatment records for the home hemodialysis unit as well. Interview with LPN (PF#1) was conducted on 12/9/22 at approximately 11:00 AM and again at 11:30 AM pertaining to the care of CR#3. LPN stated that the patient’s mother is responsible for the patient’s dialysis. When asked specifics, LPN stated that the patient’s mother sets up the machine and inputs the treatment goals. She stated then the mother goes and takes care of another one of her children while the LPN is there. When asked if she knew what the machine alarm are, or what she does when the NxStage (dialysis machine) alarms, she stated she refers to the manual. She stated that she does not get the patient’s mother unless it is a major issue. She stated that she completes the agency’s daily flowsheets and the Dialysis unit’s flowsheets as well. She stated the dialysis unit is aware of the Home Health Nurse completing the flowsheets and that she is the one monitoring the patient’s care during treatment. She stated the agency does not have any dialysis training documentation from the dialysis unit. She stated the mother went through six weeks of training and that the home hemodialysis nurse will occasionally provide on the spot training to herself and the mother on things such as new filter system (LPN did state that the mother is the one who changes the machine filter). She stated these infrequent trainings are only documented in her own notes and nothing officially from prestige or the dialysis unit. She stated she has been the patient’s nurse since June 2021. She stated when she is not there the patient’s mother will complete the entire treatment. The nurse also stated that either she or the patient's mother will communicate any issues with Children's Hospital of Philadelphia (CHOP Dialysis) directly and or/she will call NxStage (dialysis machine) directly if any machine issues. Interview with the Administrator on 12/12/22 at approximately 2:00 PM confirmed the above findings.