Exclusive Services, Inc.

“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 record review, interview and observation, the provider failed to have a complete plan of care for 1 of 5 sampled patients (Patient #2). The provider’s policy and procedure titled Care Planning, Coordination of Services, and Quality of Care (Coordination of Care), undated, documents under Purpose, “The individualized plan of care will be specific to the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment…” and under Plan of Care, “The individualized plan of care must include the following: … The types of services, supplies, and equipment required … All medications and treatments” and under Conformance with physician orders, “Drugs, services, and treatments are administered only as ordered by a physician” and under Review and revision of the plan of care, “… our HHA will promptly alert the relevant physician(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered.” Review of the record reveals Patient #2 started care on 12/09/24. Patient #2’s Home Health Certification and Plan of Care for the certification period of 02/07/25 until 04/07/25 documents his diagnoses include respiratory failure, sleep apnea, and encounter for respirator dependence during power failure and his Orders for Discipline and Treatments include, “skilled nurse to monitor vital signs during each visit, monitor home ventilator management, tracheostomy and peg tube care also restart with respiratory services CPT” and “SN [Skilled Nurse] to perform all skills related to caring for ventilator as follows: suction, trach care, equipment management/cleaning” but does not include the ventilator mode or settings and alarm parameters to be used or whether the ventilator is required at all times or can be disconnected during the day. During a home visit and observation of care on 03/05/25 at 2:45 PM, Patient #2 was observed to have a tracheostomy in place with inline suctioning device but to be disconnected from both the ventilator machine and oxygen. During an interview on 03/05/25 at 2:45 PM at the bedside Registered Nurse, Staff A stated Patient #2 only uses the ventilator at night to sleep because his oxygen level drops in his sleep and he does not need it during the day while he is awake; Staff A explained Patient #2 is always on the ventilator when she arrives in the morning at 7 AM and the first thing she does is give him his breathing treatment before disconnecting him from the ventilator, and every night at 10 PM she reconnects him to the ventilator and administers his breathing treatment before she leaves him on the ventilator for the night. During interview on 03/06/25 at 3:55 PM, the Quality Assurance Nurse and Clinical Manager provided a copy of a Modified Order dated 07/26/16 that documents, “the nurse informed changes in parameters of the mechanical ventilator ordered by [name redacted], pulmonary physician: continue with the same treatment, same meds, nebulizers, off vent during the daytime without oxygen therapy, vent only at night time,” but they were unable to explain why this was not part of the current care plan or if they had any way of knowing if this order had been discontinued since 2016.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on interview and record review, the provider failed to ensure staff follow physician orders for 1 of 5 sampled patients (Patient #2). The provider’s policy and procedure titled Feeding-Enteric, undated, documents, “Enteric feeding is completed to meet nutrition and hydration requirements by delivery through nasogastric, gastric or intestinal routes. All care will be provided in accordance with physician’s orders which specify the amount and type of feeding as well as the rate.” Review of the record reveals Patient #2 started care on 12/09/24. Patient #2’s Home Health Certification and Plan of Care for the certification period of 12/09/24 until 02/06/25 documents his diagnoses included dysphagia (trouble swallowing) and encounter for attention to gastrostomy (tube in the stomach that can be used for feeding, medications, and/or fluids). Patient #2’s Physician Order dated 12/09/24 at 7:00 PM documents a correction to the POC (Plan of Care) that the “Nutritional Requirements box should read: Enteral Nutrition- Nutren 1.5 cal (formula) 60 ml/hr [milliliters per hour] via pump and puree via oral.” Patient #2’s Home Health Certification and Plan of Care for the certification period of 02/07/25 until 04/07/25, signed by the physician, documents “Nutritional Requirements Enteral Nutrition Je. Enteral Nutrition Nutren 1.5 cal (formula) 60 ml/hr per PEG [tube in the stomach] via pump and puree via oral [by mouth].” A Communication Note dated 02/07/25 documented a call to the physician’s office to inform the pump was not working properly and a new order was needed for bolus feeding through the PEG and an order on prescription pad dated 02/08/25 documents “Please feed through PEG by bolus” but does not specify amount or frequency. A Communication Note dated 02/08/25 documents “New Order Physician Ordered- Enteral Nutrition- Nutren 1.5 cal (formula) 60 ml/hr per PEG via bolus and puree via oral.” During a home visit on 03/05/25 at 2:45 PM, Staff A explained that she gives one container of 240 ml Nutren 3 times daily as bolus feedings through Patient #2’s PEG tube using a syringe and Patient #2 confirmed this by nodding his head and giving a thumbs up sign. Review of Skilled Nurse Visit Notes reveals no evidence Patient #2 ever received Nutren 1.5 cal formula at the rate or frequency of 60 ml/hr between 12/09/24 and 03/04/25 (the beginning date of survey). Further review of the Skilled Nurse Visit Notes between these dates reveals there were 4 nurses who provided care to Patient #2 and they each documented his diet and tube feeding differently, as follows. Staff A’s Skilled Nurse Visit Notes for care of Patient #2 on 12/09/24, 12/11/24, 12/13/24, 12/18/24, 12/20/24, 12/23/24, 01/01/25, 01/03/25, 01/06/25, 01/07/25, 01/08/25, 01/10/25, 01/15/25, 01/17/25, 01/20/25, 01/22/25, 01/24/25, 01/29/25, 02/03/25, 02/05/25, 02/07/25, 02/11/25, 02/12/25, 02/14/25, 01/17/25, 02/19/25, 02/21/25, 02/26/25, 02/28/25, and 03/03/25 document he was on a puree diet on 12/09/25 but “regular soft diet” thereafter and, although she documented “he also gets enteral supplement nutrition, Nutren 1.5 caloric dense 250 ml every 8 hours via G-tube [stomach tube],” only one entry for “250 ml of complete dense parenteral nutrition supplement administration via peg tube” each of these days she worked and not 60 ml/hr as ordered. Of these dates, Staff A worked 3 PM to 11 PM (8 hours) on 12/09/24, 12/23/24, 01/06/25, 01/20/25, 02/03/25, 02/17/25, 02/24/25, and 03/03/25 and documented one feeding of Nutren 250 ml at 3 PM. Furthermore, whenever Staff A came in at 3 PM, she followed Staff C who had worked 7 AM to 3 PM and Staff C did not document administering any Nutren formula. Staff A worked 7 AM to 11 PM [16 hours] on all other dates listed, during which she documented only one feeding of Nutren 250 ml in the morning and no other tube feedings. Staff B’s Skilled Nurse Visit Notes for care of Patient #2 on 12/10/24, 12/12/24, 12/18/24, 12/19/24, 12/26/24, 01/14/25, 01/16/25, 01/21/25, 01/23/25, 01/28/25, 01/30/25, 02/04/25, 02/06/25, 02/13/25, 02/18/25, 02/20/25, 02/25/25, 02/27/25, and 03/04/25 document she administered “One can supplemental nutrition (Nutren 1.5 cal) via PEG tube” 3 times a day each time she worked and not 60 ml/hr as ordered; “3 cookies” by mouth with breakfast until 02/04/24; “breakfast cereal” by mouth in the mornings [not described as pureed], and “lunch (Puree)” “plus 1 chocolate cake” [cake not specified as pureed] by mouth at 3 PM each afternoon. Staff C’s Skilled Nurse Visit Notes for care of Patient #2 on 12/09/24, 12/14/25, 12/15/24, 12/16/24, 12/21/24, 12/22/24, 01/04/25, 01/05/25, 01/06/25, 01/11/25, 01/12/25, 01/13/25, 01/18/25, 01/19/25, 01/20/25, 01/25/25, 01/26/25, 01/27/25, 02/01/25, 02/02/25, 02/03/25, 02/09/25, 02/10/25, 02/15/25, 02/16/25, 02/17/25, 02/22/25, 02/23/25, 02/24/25, 03/01/25, 03/02/25, and 03/03/25 document no administrations of Nutren, although there was an “X” in the box for “enteral feedings”; that each day for breakfast he had “cereal” and a “piece of chocolate cake” [not indicated as pureed] and at 3 PM he had “lunch (puree)” and a “brownie.” Staff D’s Skilled Nurse Visit Notes for care of Patient #2 on 12/27/24, 12/28/24, 12/29/24, 12/30/24, 12/31/24, 01/02/25, 01/09/25, document she administered “One can supplemental nutrition (Nutren 1.5 cal) via PEG tube” at 9 AM and 3 PM each time she worked and not 60 ml/hr as ordered; “breakfast cereal” and “3 cookies” [not described as pureed] by mouth for breakfast; and “lunch (Puree)” “plus 1 chocolate cake” [cake not specified as pureed] by mouth at 3 PM each afternoon. During interview on 03/06/25 at 11:00 AM, the Clinical Manager stated the tube feeding pump was not working so they got an order to change to bolus feedings of 60 ml every hour; when told this is not what was described by Staff A, the Clinical Manager said we could call Staff A and the surveyor requested to call Staff A together. The Clinical Manager returned with Staff A already on the phone on 03/06/25 at 11:15 AM and Staff A then said she gives 60 ml of Nutren to Patient #2 by peg tube every hour and that he gets this around the clock, 24 hours a day. When informed that this would not be 3 containers as she described during the home visit yesterday, she insisted this adds up to 3 containers; when told 3 containers would only be 750 ml and if she gave 60 ml every hour for 16 hours, that would be 960 ml and not just 3 containers, she said she was using her calculator, then said she would call back. During further telephonic interview with Staff A on 03/06/25 at 11:30 AM she persisted that she gives 60 ml/hr from 3 containers during the day and the wife gives the 4th container at night but was unable to explain how they would maintain aspiration precautions to do this since Staff A lays him down to sleep before she leaves at 11 PM, and when told that 60 ml/hr for 24 hours 1440 ml per day he should be getting, not 1000 ml, so this still doesn’t add up, Staff A said she had to go and ended the call.”

“Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This Element is not met as evidenced by: Based on record review and interview, the provider failed to ensure staff documented all interventions, including ventilator settings for 1 of 1 sampled patient on a ventilator (Patient #1). The provider’s policy and procedure titled Management of Home Ventilators Policy, undated, obtained 03/06/25, documents the purpose, “Provide guidelines for home health nurses and other caregivers who care for ventilator dependants clients. Promote safety and management of high tech care in the home setting. Promote self-care in the home” and under Documentation Guidelines, “Document in clinical record: a. Ventilator settings or any changes made. Note pressures and pressure limit settings…” Review of the record reveals Patient #2 started care on 12/09/24. Patient #2’s Home Health Certification and Plan of Care for the certification period of 02/07/25 until 04/07/25 documents his diagnoses include respiratory failure, sleep apnea, and encounter for respirator dependence during power failure and his Orders for Discipline and Treatments include, “skilled nurse to monitor vital signs during each visit, monitor home ventilator management, tracheostomy and peg tube care also restart with respiratory services CPT” and “SN [Skilled Nurse] to perform all skills related to caring for ventilator as follows: suction, trach care, equipment management/cleaning” but does not include the ventilator mode or settings and alarm parameters to be used or whether the ventilator is required at all times or can be disconnected during the day. During a home visit and observation of care on 03/05/25 at 2:45 PM, Patient #2 was observed to have a tracheostomy in place with inline suctioning device but to be disconnected from both the ventilator machine and oxygen. During an interview on 03/05/25 at 2:45 PM at the bedside Registered Nurse, Staff A stated Patient #2 only uses the ventilator at night to sleep because his oxygen level drops in his sleep and he does not need it during the day while he is awake; Staff A explained Patient #2 is always on the ventilator when she arrives in the morning at 7 AM and the first thing she does is give him his breathing treatment before disconnecting him from the ventilator, and every night at 10 PM she reconnects him to the ventilator and administers his breathing treatment before she leaves him on the ventilator for the night. During interview on 03/06/25 at 3:55 PM, the Quality Assurance Nurse and Clinical Manager provided a copy of a Modified Order dated 07/26/16 that documents, “the nurse informed changes in parameters of the mechanical ventilator ordered by [name redacted], pulmonary physician: continue with the same treatment, same meds, nebulizers, off vent during the daytime without oxygen therapy, vent only at night time,” but they were unable to explain why this was not part of the current care plan or if they had any way of knowing if this order had been discontinued since 2016. The Clinical Manager also provided a Communication Note dated 03/06/25 with ventilator settings that does not indicate it is a physician order and could provide no orders for ventilator settings before this date. Review of Patient #2’s Skilled Nurse Visit Notes between 12/09/24 and 03/04/25 reveals no documentation of ventilator mode, settings or alarms being verified when he was placed on the ventilator before staff left at 11:00 PM.”