Every finding on record at Alternative Choice Home Care Nursing LLC

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure clinical records contained current and accurate documentation of patient's clinical notes, plans of care, and orders for 4 of 5 patient records reviewed who received private duty nursing (PDN) (Patients #1, #2, #4, and #5). 3. The clinical record for Patient #2 was reviewed on 2/16/22. The POC for the certification period dated 1/14/22 to 3/14/22 revealed a start of care date of 9/16/21; diagnoses included failure to thrive, non-traumatic intracerebral hemorrhage, convulsions and gastrostomy status. POC orders included SN (skilled nurse) visits 24 hours a day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment. a) The agency failed to ensure the SN updated Patient #2s clinical record documentation after the patient’s acute illness symptoms had resolved. A review of the skilled nurse “Peds Visit PM” visit note dated 1/7/22 revealed RN #8 had documented the patient had a pain level of 6 and that the patient was sick, grimaced, cried, and had increased muscle tone when he was in pain. Further review under the narrative comment section of the same document showed RN#8 had documented the patient had no signs or symptoms of pain or infection and no communication with the patient's physician or the home health agency was required during the RN’s shift. A review of the skilled nurse “Peds Visit PM” visit note dated 1/8/22 revealed RN #8 had documented the patient had a pain level of 6 and that the patient was sick, grimaced, cried, and had increased muscle tone when he was in pain. Further review under the narrative comment section of the same document showed RN#8 had documented the patient was crying, had an increased heart rate and was congested. The RN further documented in the same comment section the patient had no signs or symptoms of pain or infection and no communication with the patient's physician or the home health agency was required during the RN’s shift. Further record review revealed the agency administrator (Employee #1) had obtained a physician's order for the patient to begin Augmentin (an antibiotic used to treat bacterial infections) to be administered through Patient #2’s feeding tube twice a day for the next 10 days. A continued review of multiple SN “Peds Visit PM” visit notes completed by RN#8 over the next four weeks, dated 1/14/22, 1/18/22, 1/22/22, 1/26/22, 1/30/22, 2/4/22, 2/722, 2/8/22, 2/11/22, 2/12/22 revealed the RN had continued to document that exact same pain assessment, a pain level of 6 and that the patient was sick, grimaced, cried, and had increased muscle tone when he was in pain, as well as the same documentation in the narrative comment section, having noted the patient had no signs or symptoms of pain or infection and no communication with the patient's physician or the home health agency was required during the RN’s shift. Record review revealed no explanation as to why the pain assessment section and the narrative comment sections of the same documents had contradicted each other. During an interview on 2/22/22 at 1:45 pm, RN#8 confirmed Patient #2 had respiratory illness symptoms that had begun on or around 1/7/22. RN#8 further stated she communicated with Patient #2s physician via text and had texted the physician on 1/8/22 regarding the patient's symptoms and that the physician had ordered the Augmentin antibiotic medication to begin at that time. RN #8 stated the patient remained ill for about a week and then the symptoms had resolved and Patient #2 had returned to his normal baseline. When asked why the RN had continued to document the contradictory assessment details in the pain assessment and narrative section comments, RN #8 stated she would scroll over the electronic “Peds PM” SN visit notes and forget to remove any prior assessment detail. RN #8 was advised to review her visit notes prior to submission for documentation inaccuracies. Similar findings were found in the clinical record for Patient #1. Findings include: 1. The clinical record for Patient #4 was reviewed on 2/17/22. The Plan of Care (POC) for the certification period 1/19/22 to 3/19/22 revealed a start of care date of 1/19/22; diagnoses included cerebral palsy, quadriplegia, dysphagia, epilepsy, lack of expected normal physiological development in childhood, retention of urine, and anemia. POC orders included registered nurse (RN)/licensed practical nurse (LPN) 16 hours a day, seven days a week, for gastrostomy tube (g-tube) feedings, medication administration, vitals, monitoring, and assessment. a) The agency failed to ensure the skilled nurse (SN) documented on interventions ordered on Patient #4's POC, specifically if the SN provided passive range of motion (PROM). Further review of Patient #4's POC showed the SN was to provide PROM to Patient #4's upper and lower extremities/joints daily as tolerated by Patient #4. Review of SN notes for Patient #4 from 1/19/22 to 2/12/22 written by LPN #5 (a total of 21 visits) failed to show documentation that LPN #5 provided Patient #4 with PROM to his arms and legs at each visit. During an interview on 2/17/22 at 3:15 p.m., LPN #5 stated she ensured Patient #4 received his daily PROM. LPN #5 acknowledged she failed to document this in her notes. b) The agency failed to ensure the SN documented Patient #4's urinary output. Further review of Patient #4's POC showed Patient #4 had a diagnosis of urinary retention and the SN was to perform straight catheterization (a procedure where a soft thin tube is inserted into a patient's bladder through their urethra to assist the patient with passing urine) as needed if Patient #4 had not had any urinary output in 12 hours. Review of SN notes from 1/19/22 to 2/16/22 for Patient #4 completed by LPN #5 (total of 21 visits) showed LPN #5 failed to document Patient #4's urinary output. During an interview on 2/17/22 at 3:15 p.m., LPN #5 stated she confirmed with family members who assist Patient #4 with changing his incontinence pads regularly to ensure that Patient #4 voided urine every 12 hours. LPN #5 stated Patient #4's issue with urinary retention had not occurred in a year or two, but LPN #5 stated she monitored Patient #4 for this issue. LPN #5 stated she recently started to use a voiding log to track Patient #4's frequency of urinary output but she was still working out the method to use this log and had not been consistent with its use. LPN #5 stated she did not document Patient #4's urinary output in her SN notes for Patient #4. c) The agency failed to ensure the SN documented administration of medications as ordered for Patient #4. Review of Patient #4's medical administration record (MAR) for February showed LPN #5 failed to document administration of the following medications ordered for Patient #4 on 2/3/22: Glycopyrrolate, Baclofen, Levetiracetam, Ipratropium-Albuterol, Diazepam. LPN #5 failed to document administration of the following medications for Patient #4 on 2/10/22: Glycopyrrolate, Ferrous Sulfate, Cholecalciferol, Baclofen, Levetiracetam, Polyethylene Glycol Ipratropium-Albuterol Famotidine, Diazepam, Cetirizine, and Probiotic Formula. LPN #5 documented she administered Patient #4 Famotidine, a medication ordered for administration one time a day at bedtime, two times on 2/6/22, 2/7/22, and 2/11/22. During an interview on 2/17/22 at 3:15 p.m., LPN #5 stated she administered medication to Patient #4 as ordered. LPN #5 stated she forgot to document on 2/3/22 and 2/10/22 and mistakenly over-documented on 2/6/22, 2/7/22 and 2/11/22. 2. The clinical record for Patient #5 was reviewed on 2/17/22. The POC for the certification period 1/19/22 to 3/19/22 revealed a start of care date of 1/19/22; diagnoses included congenital malformation of the nervous system, congenital hydrocephalus, failure to thrive (child), blindness, seizures, and hearing loss. POC orders included SN 16 hours a day, seven days a week, for gastrostomy tube feedings, medication administration, vitals, monitoring and assessment. a) The agency failed to ensure the skilled nurse (SN) documented on interventions ordered on Patient #5's POC, specifically if the SN provided passive range of motion (PROM). Further review of Patient #5's POC showed the SN was to provide PROM to Patient #5's upper and lower extremities/joints daily as tolerated by Patient #5. Review of SN notes for Patient #5 from 1/19/22 to 2/16/22 written by LPN #5 (a total of 26 visits) failed to show documentation that LPN #5 provided Patient #5 with PROM to her arms and legs at each visit. During an interview on 2/17/22 at 3:15 p.m., LPN #5 stated she ensured Patient #5 received her daily PROM. LPN #5 acknowledged she failed to document this in her notes. b) The agency failed to ensure the SN documented administration of medications as ordered for Patient #5. Review of the February MAR for Patient #5 showed LPN #5 failed to document administration of Glycopyrrolate and Levetiracetam on 2/3/22. Review of the February MAR also showed LPN #5 documented administration of Diazepam on 2/12/22 and 2/13/22- a medication to be administered rectally to Patient #5 if she suffered a seizure that lasted longer than 5 minutes. During an interview on 2/17/22 at 3:15 p.m., LPN #5 stated Patient #5 received her medications as ordered. LPN #5 stated she forgot to document the administration of the two medications on 2/3/22. LPN #5 stated she had not given Patient #5 the Diazepam on 2/12/22 and 2/13/22 and she had never given Patient #5 that medication as Patient #5 had not suffered a seizure lasting longer than 5 minutes. LPN #5 stated Patient #5's seizures last approximately 35 seconds in length and Patient #5 did not have a seizure on 2/12/22 or 2/13/22. LPN #5 stated she mistakenly documented administration of the Diazepam for Patient #5.

A complaint survey prompted by #CO2823 was completed on 11/17/21. Interview and record review revealed the agency routinely arranged for one registered nurse (RN) to furnish services to multiple pediatric patients living within the same household (separate bedrooms) and failed to provide patients with 24 hour care on an individual basis as set forth on the plan of care. The agency further failed to ensure plans of care were complete and accurately reflected the care to be provided to each patient and RN's had regularly assessed, coordinated with the physician and documented the current status of each patient. In one instance, the RN failed to assess and coordinate with the physician for three days after one patient who received peritoneal dialysis had complained of abdomen pain and subsequently was ordered a 21 day course of antibiotics. On 11/9/21 at 3:19 p.m. the agency was advised these failures created an Immediate Jeopardy situation for all patients being served by the agency.he agency was directed to compose a plan to immediately address the provision of services as ordered by the physician, coordination with the physician, routine reassessment of patients by the RN and accurate documentation of the patient's current status. The agency provided two separate proposed plans to address the circumstances surrounding the Immediate Jeopardy, however neither plan contained sufficient information, direction and approach to remove the identified concerns. No additional plans to address the Immediate Jeopardy situation were presented by the agency and on 11/17/21 the survey was concluded with the situation of Immediate Jeopardy unaddressed. The following Condition level deficiencies were cited related to the circumstances of the Immediate Jeopardy: 484.60 Care Planning, Coordination, Quality of Care 484.75 Skilled Professional Services Additionally, 5 standard deficiencies were cited. The following Condition level deficiencies were cited in addition to the Condition level citations related to the circumstances of the Immediate Jeopardy: 484.65 Quality Assessment/Performance Improvement 484.80 Home Health Aide Services 484.105 Organization and Administration of Services 4840110 Clinical Records Additionally, 3 standard deficiencies were cited. Following the above survey, the agency submitted an acceptable plan to address the circumstances of the immediate jeopardy and the state agency (SA) entered the agency on 12/09/21 to review the agency's execution of the plan. On 12/13/21, in consultation with CMS, the situation of immediate jeopardy was removed, however Condition level deficiencies and standards remained uncorrected as cited above. Refer to CFR 484.36(a)(2)(i) guidelines. An agency, which has a Condition of Participation out of compliance with any of the requirements, is precluded from conducting (if approved) or applying to conduct a Nurse Aide Training Program or Competency evaluation for two (2) years from the exit date.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on the nature and number of standard level deficiencies and a pattern of deficient practice referenced to the Condition, it was determined the Condition of Participation 484.60 CARE PLANNING, COORDINATION, QUALITY OF CARE was out of compliance. A total of 22 clinical records were reviewed for compliance with the Condition and Standards for Care Planning, Coordination and Quality of Care. Record review revealed a pattern of failures in regard to the development and implementation of patient's plans of care and coordination of care with the patient's physicians. A complaint investigation #CO initiated on 11/1/21 revealed the agency failed to ensure plans of care were complete and accurate; failed to ensure pediatric patients receiving private duty nursing (PDN) received care as ordered by the physician-approved plan of care and failed to coordinate with the physician regarding changes in a patient's condition. These failures led to the potential for harm to all patients served by the agency. Specifically: G572 - Standard: Plan of Care - The agency failed to ensure each patient received home health services in accordance with the written plan of care established and periodically reviewed by a physician for 18 of 18 pediatric patients reviewed who received private duty nursing (PDN) services. G574 - Standard: The Plan of Care must include - The agency failed to ensure each patient's Plan of Care (POC) covered the patient's status, all pertinent treatments and medications and the frequency and duration of visits for 18 of 18 pediatric patients reviewed receiving PDN.

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 observation, interview and record review, the agency failed to ensure each patient received home health services in accordance with the written plan of care established and periodically reviewed by a physician for 18 of 18 pediatric patients reviewed who received private duty nursing (PDN) services (Patients #1 through #18). C. Interview and record review revealed the agency was providing RN services 24 hours a day for five pediatric patients (Patients #1 through #5) residing in Home C. During the day there was one RN assigned every day from 8:00 a.m. to 4:00 p.m. (8 hours) for two of the patients (Patients #1 and #2) who were at home during the day, and one RN who was assigned to three of the patients (Patients #3, #4, and #5) who attended school during the day. During the nights one RN was assigned from 4:00 p.m. to 8:00 a.m. (16 hours) and provided services to all five of the pediatric patients. During a home visit on 11/2/21 at 11:30 a.m., Home C was observed to have two individual bedrooms in the basement where two of the pediatric patients slept during overnight hours, and three individual bedrooms on the second level where three of the pediatric patients slept during overnight hours. RN #9 monitored each patient every two hours during the night. 1. The clinical record for Patient #1 was reviewed on 11/1/21. The POC for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnosis included spastic quadriplegic cerebral palsy, unspecified convulsions, and obstructive sleep apnea. POC orders included SN services up to sixteen hours per day and SN services up to eight hours per day for a total of up to 24 hours per day for gastrostomy tube feedings, medication administration, monitoring, vital signs (VS), and assessments, and CNA services up to five hours per day for assistance with personal care and light housekeeping. Further review of the POC revealed Patient #1 required 24-hour nursing contact. Review of overnight (4:00p.m. through 8:00 a.m.) and day (8:00 a.m. through 4:00 p.m.) SN visits dated 10/22/21 through 11/5/21 revealed Patient #1 received nursing care 24 hours every day for this period from two RNs. Patient #1s four siblings received the same amount of care from the same RN during each shift. Specifically, the RN was unable to provide continuous care for Patient #1 when attending to four other siblings residing in the home. 2. The clinical record for Patient #2 was reviewed on 11/3/21. The POC for the certification period dated 10/10/21 to 12/8/21 revealed a start of care date of 6/17/20; diagnosis included spastic quadriplegic cerebral palsy, disorders of the lung, encephalopathy, epilepsy, hypoxemia, and feeding difficulties. POC orders included SN services up to sixteen hours per day for nine weeks and up to eight hours per day for nine weeks for tracheostomy and ventilator care, gastric tube (GT) feedings, vital signs, monitoring, and assessments, and CNA services up to seven times a day for nine weeks to assist with personal care and light housekeeping. Further review of the Plan of Care revealed Patient #2 required 24-hour nursing contact. Review of overnight (4:00p.m. through 8:00 a.m.) and day (8:00 a.m. through 4:00 p.m.) SN visits dated 8/31/21 through 11/5/21 revealed Patient #2 received nursing care 24 hours every day for this period from two RNs. Patient #2's four siblings received the same amount of care from the same RN during each shift. Specifically, the RN was unable to provide continuous care for Patient #2 when attending to four other siblings residing in the home. 3. The clinical record for Patient #3 was reviewed on 11/2/21. The POC for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnosis included post traumatic seizures, hemiplegia (paralysis of one side of the body), and a gastrostomy tube (G-tube). POC orders included SN services up to 24 hours a day for 60 days for g-tube feedings, medication administration, vital signs, monitoring, and assessments, and CNA services up to six hours a day for 60 days for assistance with personal care and light housekeeping. Further review of the POC revealed Patient #3 required 24-hour nursing contact. Review of day (8:00 a.m. through 4:00 p.m.) SN visits from 10/22/21 through 11/2/21 revealed Patient #3 received nursing care eight hours every day from one RN provided by the agency, or from his school's Individualized Education Plan (IEP) program if an agency nurse was not available to go to school with the patient. Two of Patient #3's siblings (Patient #4 and #5) were also provided the same RN during the day shift. One of Patient #3's sibling did not attend the same classroom as Patient #3 and another sibling. The RN was unable to provide continuous care to Patient #3 while moving between two classroomsReview of overnight (4:00p.m. through 8:00 a.m.) SN visits dated 10/22/21 through 11/2/21 revealed Patient #3 received nursing care 16 hours every day for this period from one RN. Patient #3's four siblings received the same amount of care from the same RN during each shift. Specifically, the RN was unable to provide continuous care for Patient #3 when attending to four other siblings residing in the home. 4. The clinical record for Patient #4 was reviewed on 11/8/21. The POC for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnosis included intracranial hemorrhage (bleeding in the brain), gastrostomy tube, autism, and developmental delays of speech and language. Plan of care orders included SN services up to 24 hours per day for 60 days for g-tube feedings, medication administration, vital signs, monitoring, and assessments, and CNA services up to five hours per day seven days a week for assistance with personal care and light housekeeping. Further review of the Plan of Care revealed Pediatric Patient #4 required 24-hour nursing contact. Review of day (8:00 a.m. through 4:00 p.m.) SN visits from 10/22/21 through 11/2/21 revealed Patient #4 received nursing care eight hours every day from one RN provided by the agency, or from his school's Individualized Education Plan (IEP) program if an agency nurse was not available to go to school with the patient. Two of Patient #4's siblings (Patient #3 and #5) were also provided the same RN during the day shift. One of Patient #4's siblings did not attend the same classroom as Patient #4 and another sibling. The RN was unable to provide continuous care to Patient #4 while moving between two classrooms. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/22/21 through 11/2/21 revealed Patient #4 received nursing care 16 hours every day for this period from one RN. Patient #4's four siblings received the same amount of care from the same RN during each shift. Specifically, the RN was unable to provide continuous care for Patient #4 when attending to four other siblings residing in the home. 5. The clinical record for Patient #5 was reviewed on 11/8/21. The POC for the certification periods dated 9/1/21 to 10/30/21 and 10/31/21 to 12/29/21 revealed a start of care date of 1/4/21; diagnosis included intestinal obstruction, gastrostomy tube, autism, attention-deficit hyperactivity disorder (ADHD), stenosis and atresia (narrowing) of the small intestine, and diarrhea. POC orders included SN services up to 24 hours per day for 60 days for g-tube feedings, medication administration, vital signs, monitoring, and assessments, and CNA services up to five hours per day seven days a week for assistance with personal care and light housekeeping. Further review of the POC revealed Patient #5 required 24-hour nursing contact. Review of day (8:00 a.m. through 4:00 p.m.) SN visits from 9/1/21 through 11/8/21 revealed Patient #5 received nursing care eight hours every day from one RN provided by the agency, or from his school's Individualized Education Plan (IEP) program if an agency nurse was not available to go to school with the patient. Two of Patient #5's siblings (Patient #3 and #4) were also provided the same RN during the day shift. Two of Patient #5's siblings did not attend the same classroom as Patient #5. The RN was unable to provide continuous care to Patient #5 while moving between two classrooms. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/22/21 through 11/2/21 revealed Patient #5 received nursing care 16 hours every day for this period from one RN. Patient #5's four siblings received the same amount of care from the same RN during each shift. Specifically, the RN was unable to provide continuous care for Patient #5 when attending to four other siblings residing in the home. During an interview on 11/2/21 at 11:30 a.m., RN #9 stated all five pediatric patients needed 24-hour care. She further stated on her shift, the 4:00 p.m. to 8:00 a.m. shift, she checked on each of the patients every two hours. Due to continuous care required for the the pediatric patients and the extensive medical needs and fragility of all the patients (Patients #1 through #5) in Home C, each was to have received 24 hour nursing contact and tasks as ordered in their POCs. The agency failed to ensure each patient received home health services and supervision in accordance with their written POC. B. Interview and record review revealed the agency was providing RN services 24 hours a day for six pediatric patients (Patient #13 through #18) residing in Home B. There was one RN assigned every day from 8:00 a.m. to 4:00 p.m. (8 hours) and another RN assigned from 4:00 p.m. to 8:00 a.m. (16 hours). The one RN for each shift provided services to all six pediatric patients. During a home visit on 11/4/21 at 9:00 a.m., Home B was observed to have three individual bedrooms in the basement where three of the pediatric patients slept during overnight hours, one shared bedroom in the basement where two patients slept during overnight hours and one bedroom on the main level where one patient slept during overnight hours. There were cameras set up in each room to monitor machine settings during the overnight as well as baby monitors in each room to listen for sound. RN #7 stated she monitored the cameras and the baby monitors through her handheld device while in the bedroom on the main level where one of the patients slept. RN #7 further stated she was the only staff residing in the home and taking care of the six pediatric patients during the 16-hour overnight shifts. RN #7 stated all other RN's lived within 15 minutes of the home and were the back-up plan in case of an emergency. 1. The clinical record for Patient #13 was reviewed on 11/5/21. The POC for the certification period dated 10/13/21 to 12/11/21 revealed a start of care date of 12/17/20; diagnoses included disorders of lung, chronic respiratory failure, myotonic muscular dystrophy, dysphagia, dependence on ventilator, tracheostomy status and gastrostomy status. POC orders included RN visits 24 hours daily for ventilator care during naps and overnight, tracheostomy care, chest physiotherapy (CPT) three times daily, g-tube feedings and associated care, vital signs, monitoring and assessment and CNA visits up to six and half hours daily for personal care, light housekeeping and continuous line of sight monitoring. Further review of the POC revealed Patient #13 required 24-hour nursing contact. Review of overnight (4:00 p.m. through 8:00 a.m.) and day (8:00 a.m. through 4:00 p.m.) SN visits dated 10/13/21 through 11/5/21 revealed Patient #13 received nursing care 24 hours every day from one RN. However, Patient #13's five siblings received the same amount of care from the same RN during each shift. Specifically, during overnight shifts, the RN was unable to provide continuous care for Patient #13 when attending to five other siblings residing in three to four separate bedrooms. 2. The clinical record forPatient #16 was reviewed on 11/8/21. The POC for the certification period dated 10/10/21 to 12/8/21 revealed a start of care date of 12/14/20; diagnoses included bronchopulmonary dysplasia, congenital malformations of respiratory system, chronic respiratory failure, dependence on ventilator, trach status and gastrostomy status. POC orders included RN to provide around the clock care to include medication administration, g-tube feedings and associated care, chest physiotherapy (CPT) three times daily, maintain ventilator during overnight only, trach care, suctioning twice daily, monitoring and assessment. Further review of the POC revealed Patient #16 required 24-hour nursing contact. Review of overnight (4:00p.m. through 8:00 a.m.) and day (8:00 a.m. through 4:00 p.m.) SN visits dated 10/13/21 through 11/5/21 revealed Patient #16 received nursing care 24 hours every day for this period from one RN. However, Patient #16's five siblings received the same amount of care from the same RN during each shift. Specifically, during overnight shifts, the RN was unable to provide continuous care for Patient #16 when attending to five other siblings residing in three to four separate bedrooms. 3. The clinical record for Patient #15 was reviewed on 11/8/21. The POC for the certification period dated 9/25/21 to 11/22/21 revealed a start of care date of 7/31/20; diagnoses included spastic quadriplegic cerebral palsy, epilepsy, neuromuscular scoliosis, chronic respiratory failure and gastrostomy status. POC orders included RN visits up to 24 hours per day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment and CNA visits up to six hours daily for personal care, light housekeeping and continuous line of sight monitoring. Further review of the POC revealed Patient #15 required 24-hour nursing contact. Review of overnight (4:00p.m. through 8:00 a.m.) and day (8:00 a.m. through 4:00 p.m.) skilled SN visits dated 10/13/21 through 11/5/21 revealed Patient #15 received nursing care 24 hours every day for this period from one RN. However, Patient #15's five siblings received the same amount of care from the same RN during each shift. Specifically, during overnight shifts, the RN was unable to provide continuous care for Patient #15 when attending to five other siblings residing in three to four separate bedrooms. 4. The clinical record for Pediatric Patient #17 was reviewed on 11/9/21. The POC for the certification period dated 10/13/21 to 12/11/21 revealed a start of care date of 12/17/20; diagnoses included anoxic brain damage, hypoxic ischemic encephalopathy, quadriplegia, scoliosis, contracture of unspecified joint and gastrostomy status. POC orders included RN visits 24 hours per day for g-tube feedings, medication administration, vital signs, monitoring and assessment and CNA visits up to seven hours daily for personal care, light housekeeping and continuous line of sight monitoring. Further review of the POC revealed Patient #17 required 24-hour nursing contact. Review of overnight (4:00p.m. through 8:00 a.m.) and day (8:00 a.m. through 4:00 p.m.)SNvisits dated 10/13/21 through 11/5/21 revealed Patient #17 received nursing care 24 hours every day for this period from one RN. However, Patient #17's five siblings received the same amount of care from the same RN during each shift. Specifically, during overnight shifts, the RN was unable to provide continuous care for Patient #17 when attending to five other siblings residing in three to four separate bedrooms. 5. The clinical record for Patient #14 was reviewed on 11/5/21. The POC for the certification period dated 10/4/21 to 12/2/21 revealed a start of care date of 10/9/20; diagnoses included pulmonary valve atresia, isomerism of atrial appendages, asplenia and gastrostomy status. POC orders included RN visits up to 24 hours per day for g-tube feedings and associated care, chest physiotherapy (CPT) twice daily, medication administration, vital signs, monitoring and assessment and CNA visits up to five hours daily for nine weeks for personal care, light housekeeping and continuous line of sight monitoring. Further review of the POC revealed Pediatric Patient #14 required 24-hour nursing contact. Review of overnight (4:00p.m. through 8:00 a.m.) and day (8:00 a.m. through 4:00 p.m.) SN visits dated10/13/21 through 11/5/21 revealed Patient #14 received nursing care 24 hours every day for this period from one RN. However, Patient #14's five siblings received the same amount of care from the same RN during each shift. Specifically, during overnight shifts, the RN was unable to provide continuous care for Patient #14 when attending to five other siblings residing in three to four separate bedrooms. 6. The clinical record for Patient #18 was reviewed on 11/3/21. The POC for the certification period dated 9/16/21 to 11/12/21 revealed a start of care date of 9/16/21; diagnoses included failure to thrive, non-traumatic intracerebral hemorrhage, convulsions and gastrostomy status. POC orders included RN visits up to 24 hours a day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment. Further review of the Plan of Care revealed Patient #18 required 24-hour nursing contact. Review of overnight (4:00p.m. through 8:00 a.m.) and day (8:00 a.m. through 4:00 p.m.) SN visits dated 10/13/21 through 11/5/21 revealed Patient #18 received nursing care 24 hours every day for this period from one RN. However, Patient #18's five siblings received the same amount of care from the same RN during each shift. Specifically, during overnight shifts, the RN was unable to provide continuous care for Patient #18 when attending to five other siblings residing in three to four separate bedrooms. Due to continuous care required for the the pediatric patients and the extensive medical needs and fragility of all the patients (Patients #13 through #18) in Home B, each was to have received 24 hour nursing contact and tasks as ordered in their POCs. The agency failed to ensure each patient received home health services and supervision in accordance with their written POC. Findings include: AGENCY POLICY According to the agency policy titled, "Physician Role in Home Care of Patients Plan of Care (POC) and Interim Orders," dated 2007, (in pertinent parts): "Patient Care follows a written POC, established and periodically reviewed by a doctor of medicine, osteopathy, or podiatric medicine." According to the agency policy titled, "Job Description Registered Nurse," dated 2007 (in pertinent parts): "Definition: Provides skilled nursing care in accordance with the patient's plan of treatment, including comprehensive health and psychosocial evaluation, monitoring of the patient's condition, health promotion and prevention, coordination of service, teaching and training activities, provision of direct nursing care and planning for patient's needs or service requests." A. Interview and record review revealed the agency was providing registered nurse (RN) services 24 hours a day for seven pediatric patients (Patients #6 through #12) residing in Home A. There were two to three RNs assigned every day from 8:00 a.m. to 4:00 p.m. (8 hours) and one RN assigned daily from 4:00 p.m. to 8:00 a.m. (16 hours) to provide services to all seven pediatric patients. During a home visit on 11/4/21 at 9:00 a.m., Home A was observed to have two bedrooms on the main floor where Patient #12 slept in one bedroom during the overnight hours and Patient #11 slept in the other main floor bedroom during the overnight hours. On the second floor of the home were two bedrooms where Patient #6, #7 and #9 slept in one of the bedrooms for the overnight hours and Patient #8 and #10 slept in the other bedroom. RN #5 stated that most of the children had alarms that would alert her if they were in need of help and she was in the other room attending to another child's needs. Additionally, RN #5 stated sound traveled in the home easily and if RN #5 was in need of assistance, if two of the children required care at the same time or during an emergency, she could call out and one of the certified nursing aides (CNA's) who resided in the home could come assist RN #5. 1. The clinical record for Patient #8 was reviewed on 11/8/21. The Plan of Care (POC) for the certification period 9/19/21 to 11/17/21 revealed a start of care date of 5/27/20; diagnoses included dependence on renal dialysis, dysphagia, anemia in chronic kidney disease, unspecified lack of expected normal physiological development in childhood and congenital hypothyroidism. Plan of care orders included RN/licensed practical nurse (LPN) up to 24 hours a day for peritoneal dialysis, g-tube feedings, medication administration, vitals, monitoring and assessment; and certified nursing aide (CNA) up to six hours a day for assistance with personal care and light housekeeping. Two skilled workers (SN and CNA) required to provide safe and efficient care with activities of daily living (ADL) related to fragility of Patient #8 and multiple environmental hazards such as oxygen tubing, peritoneal dialysis, completing daily sterile dressing changes to the peritoneal catheter site, g-tube equipment, and additional bathing and dressing due to frequent vomiting related to feedings. Further review of the POC revealed Patient #8 required 24 hour nursing contact. a. The agency failed to ensure the patient received home health services in accordance with the written POC. Specifically, the agency failed to ensure Patient #8 received 24 hour nursing contact. Review of visit notes a.m. (8:00 a.m. through 4:00 p.m.) and p.m. (4:00 p.m. to 8:00 a.m.) dated 9/19/21 to 11/9/21, revealed Patient #8 received nursing care 24 hours every day with RN #5 providing the care for the 16 hour p.m. shift. However, Patient #8's six siblings received the same amount of care from RN #5 during each shift. Specifically, during overnight shifts, RN #5 was unable to provide continuous 24 hour contact for Patient #8 while also attending to her six siblings residing in three separate bedrooms from Patient #8. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that Patient #8 required 24 hour care and so did Patient #6, #7, #9, #10, #11 and #12. b. The agency failed to ensure the patient received home health services in accordance with their written POC. Specifically, the agency failed to ensure Patient #8 received her peritoneal dialysis for 11 hours as ordered. Review of the POC for the certification period 9/19/21 to 11/17/21 revealed Patient #8 was to receive daily peritoneal dialysis with delivery system of continuous cycling peritoneal dialysis/ intermittent peritoneal dialysis, mode low fill, total dialysis volume 3400ml therapy time 11 hours, total fill 300 ml(33ml/kg/fill) last fill 100 ml, cycles 11 and final dextrose concentration 2%. Review of the visit notes p.m. (4:00 p.m. to 8:00 a.m.) dated 9/9/21 to 11/10/21 revealed evidence that RN #5 documented Patient #8 received peritoneal dialysis for 8 hours (9:00 p.m. to 5:00 a.m.) 43 times. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated she provided Patient #8 with 11 hours of dialysis as ordered and it was an error if that was not how it was charted. RN #5 stated Patient #8 had been receiving peritoneal dialysis for 11 hours for over a year now with the exception of the time increasing to 12 hours for a short period when Patient #8 was ill. c. The agency failed to ensure the patient received home health services in accordance with the written POC. Specifically, the agency failed to ensure Patient #8 received her g-tube feedings as ordered. Review of the POC dated 9/19/21 to 11/17/21 revealed g-tube enteral feeding orders of two scoops of Beneprotein with 90 grams Nutramigen and 540 ml of water, the mix 515 ml of Beneprotein/Nutramigen mixture with 432 ml Peptamen Jr 1 cal for a total of 947 ml of formula to run at 40 ml/hour continuously. Review of visit notes a.m. (8:00 a.m. to 4 p.m.) and p.m. (4:00 p.m. to 8:00 a.m.) dated 9/19/21 to 10/4/21 revealed RN #5 documented Patient #8 received a feeding flow rate of 39 ml/hour on 9/19/21 during the p.m. shift, RN #4 documented Patient #8 received a feeding flow rate of 38 ml/hour on 9/20/21 and 9/21/21 during the a.m. shift. RN #3 failed to document a feeding flow rate seven times and RN #13 failed to document a feeding flow rate one time. On 10/5/21 RN #5 wrote in the narrative section of her note that Patient #8's g-tube feeds were changed to Peptamen Junior at 38 ml/hour over 24 hours, with no other information provided. Record review failed to show evidence that a physician order was written to reflect this change to the POC. Record review revealed from 10/5/21 to 11/1/21 RN #4 documented 17 times Patient #8 was receiving a feeding flow rate of 38ml/hour., RN #5 documented 26 times Patient #8 was receiving a feeding flow rate of 38 ml/hour. RN #3 failed to document a feeding flow rate six times, RN #14 failed to document a feeding flow rate one time and RN #15 documented Patient #8 was receiving a feeding flow rate 38ml/hour one time. Documentation of all of these feeding flow rates were out of compliance with the POC order of 40ml/hour. Review of visit p.m. note on 11/1/21 revealed that RN #5 documented Patient #8 had many changes to her POC that day including an increase in her diet per the registered dietician (RD), however record review failed to show any physician orders were obtained to reflect those changes. RN #5 failed to document specifically what the increase in diet from the RD was. Review of visit notes dated 11/1/21 -11/6/21 revealed RN #4 documented Patient #8 received her feeding at a flow rate of 41ml/hr four times and RN #5 documented Patient #8 received her feeding flow rate at 38ml/hour two times and 41 ml/hour four times. All of these feeding flow rates were out of compliance with the POC order of 40ml/hour. During an interview on 11/9/21 at 11:32 p.m., RN #3 stated that the RD would make changes regarding the type of formula to use and the flow rate and Patient #8's foster mother (RN #5) would inform the RN's caring for Patient #8 of the changes made to Patient #8's g-tube feedings. RN #3 stated sometimes the changes would come after Patient #8's foster mother took Patient #8 to the doctor and the foster mother received after visit instructions from the physician. The foster mother would email the nurses caring for Patient #8 the instructions. he nurses would then alter the treatment they provided to Patient #8 based on the instructions in the most current after visit summary and the information provided by the foster mother. RN #3 stated sometimes there would be a dietary summary provided that would inform the nurses on the current rate and titration. RN #3 stated sometimes Patient #8 had orders to receive 40 ml/hour and sometimes it has been 38 ml/hour. RN #3 further stated Patient #8 struggled at times with her feeding flow rate and the nurses increased her feeding flow slowly. During an interview on 11/16/21 at 2:07 p.m., Patient #8's foster mother (RN #5) stated the feeding flow rate for Patient #8 came from the dietician and when she received a change in the feeding flow rate she forwarded the changes to the agency via an email. Patient #8's foster mother stated she followed the same process if one of Patient #8's physicians made any change to Patient #8's POC. Patient #8's foster mother stated she received after visit instructions from the doctor and she would send these instructions to agency and the other nurses caring for Patient #8, as she assumed all of these instructions were orders to be followed. During an interview on 11/9/21 at 8:32 a.m., the director of nursing (DON) stated many of the pediatric patients receiving private duty nursing from the agency had multiple changes to their POCs throughout the POC. The DON stated in regards to the pediatric patients being cared for in Home A (Patients #6 through #12), the children's mother/foster mother emailed the agency any time she took one of the children to a doctor's appointment and received instructions from the doctor that varied from the child's orders on the current POC. The DON acknowledged that the agency was not obtaining physician orders for the changes and instead felt the emails the mother/foster mother sent, containing the instructions the mother/foster mother received from the physician/dietician, were sufficient to allow the RN's caring for the child to change treatment/medications provided. 2. The clinical record for Pediatric Patient #9 was reviewed on 11/03/21. The POC for the certification period dated 10/16/21 to 12/14/2021 revealed a start of care date of 10/16/21; diagnoses included chronic respiratory failure], dependence on a respirator ventilator, tracheostomy , epilepsy , Ventriculoperitoneal Shunt , gastrostomy and hearing loss. POC orders included Registered Nurse (RN) services for up to 16 hours per day and up to 8 hours per day for tracheostomy care, gastrostomy tube (gt) feedings, vital signs, monitoring, and assessment. a. The agency failed to ensure the patient received home health services in accordance with the written POC. Specifically, the agency failed to ensure Patient #9 received 24 hour nursing contact. Review of visit notes a.m. (8:00 a.m. through 4:00 p.m.) and p.m. (4:00 p.m. to 8:00 a.m.) dated 10/16/21 to 11/9/21, revealed Patient #9 received nursing care 24 hours every day with RN #5 providing the care for the 16 hour p.m. shift. However, Patient #9's six siblings received the same amount of care from RN #5 during each shift. Specifically, during overnight shifts, RN #5 was unable to provide continuous 24 hour contact for Patient #9 while also attending to his six siblings residing in three separate bedrooms from Patient #9. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that Patient #9 required 24 hour care and so did Patient #6, #7, #8, #10, #11 and #12. b) The agency failed to ensure medications were administered as ordered by the physician per the POC. According to the POC, additional specific skilled nursing interventions include medication administration and management following the physician’s orders. Medications for Patient #9 included 9 medications to be administered at minimum, daily and 11 other medications to be administered as needed, as determined by the RN. Detailed medication orders included: Trazadone, 25 milligrams, through the Patient’s feeding tube every night at bedtime Melatonin, 3 milligrams, through the feeding tube every night at bedtime Ciprodex Otic Suspension, 4 drops applied topically, directly around tracheostomy site, 2 times daily Sildenafil Citrate, 10 milligrams, through the feeding tube, three times daily Acetaminophen, 160 milligrams, through the feeding tube, as needed for pain or increased temperature Triamcinolone, applied topically around the GT site, one time daily as needed Record review of the electronic medication administration record from Patient #9's start of care date of 10/16/21 through 10/31/21 revealed no documentation the Trazadone or Melatonin medication had ever been administered. A review of documentation completed by RN #5 showed the RN provided care for Patient #9 every night between the start of care date of 10/16/21 through 10/31/21. The RN documented meds were administered in the narrative section of the document, however, which medications were administered was never specified. Additional record review of the electronic medication administration record dated 10/16/21 and 10/31/21 also revealed the Ciprodex Otic Suspension had only been applied two of the 32 times it should have been applied by the RN. During an interview with the DON on 11/17/21 at 10:42 a.m., the DON stated it was the agency's expectation the RN would document all administered medications on the electronic medication administration record as soon as the medication was given and that this was standard nursing practice. The DON went on to state some of the staff RN’s had indicated they were unaware the agency had an electronic medication administration record. Due to the missing medication administration record documentation, the agency failed to ensure Patient #9 received his medications as ordered by the physician. b) The agency failed to ensure the RN staff performed chest physical therapy (CPT) [a type of respiratory care performed to promote coughing and the removal of lung secretions through percussion on the chest area] two times daily and may increase frequency for increased mucous secretions, as ordered by the physician per the POC for Patient #9. A review of documentation completed by RN staff dated 10/16/21 through 11/02/21 showed no record Patient #9 had ever received CPT as ordered. During an interview on 11/15/21 at 6:11 p.m., RN #14stated she was unaware CPT had been ordered for Patient #9. c) The agency failed to notify the physician when pediatric Patient #9’s vital signs were outside of the designated parameters as ordered in the POC. Specifically, The RN was to check the Patient #9's vital signs and oxygen saturation every shift and as needed and notify the physician of: Temperature greater than 101.5 or less than 96 Pulse greater than 100 or less than 50 Respirations greater than 30 or less than 20 Systolic blood pressure greater than 91 Diastolic blood pressure greater than 56, and, Oxygen saturation less than 90% A review of clinical record documentation showed the assigned registered nurses checked the Patient's vital signs 21 times between the dates of 10/21/21 and 11/02/21. The recorded results showed pediatric Patient #9’s vital signs were greater than the ordered parameters in all 21 recorded vital sign findings. During an interview on 11/09/21 at 11:34 a.m., RN#14 stated she routinely provided care for Patient #9. When RN #14 was asked about the recorded vital signs that were consistently greater than the identified parameters, the RN stated she did not notify the physician because Patient #9's vital sign findings were usually in the range of the findings recorded. RN #14 acknowledged she should have notified the physician when her findings were outside the ordered parameters. 3. The clinical record for Patient #6 was reviewed on 11/16/21. The POC for the certification periods dated 8/31/21 to 10/29/21 and 10/30/21 to 12/28/21 revealed a start of care date of 3/4/21; diagnosis included necrotizing enterocolitis, postgastric surgery syndromes, dysphagia (swallowing difficulties), sepsis, and gastrostomy tube placement. POC orders included skilled nursing (SN) services sixteen times a day for 1 hour (16 hours total) for 60 days total and SN services eight times per day for 1 hour (eight hours total) for 60 days for total parenteral nutrition, medication administration, vitals, monitoring, and assessment, and CNA services up to seven times per day for one hour (seven hours total) for 60 days for assistance with personal care and light housekeeping. Further review of the POC revealed Patient #6 required 24-hour nursing contact. Review of overnight (4:00p.m. through 8:00 a.m.) and day (8:00 a.m. through 4:00 p.m.) SN visit documentation dated 8/31/21 through 11/5/21 revealed Patient #6 received nursing care 24 hours every day for this period from two RNs. Patient #6's six siblings received the same amount of care from the same RN during each night shift. Specifically, the RN was unable to provide continuous care for Patient #6 when attending to six other siblings residing in the home. 4. The clinical record for Patient #7 was reviewed on 11/8/21. The POC for the certification period dated 10/16/21 to 12/14/21 revealed a start of care date of 10/16/21; diagnoses included hypoxic ischemic encephalopathy, anoxic brain damage, cortical blindness, gastrostomy status, congenital hypertonia, and lack of expected normal physiological development in childhood POC orders included RN visits up to 24 hours daily for gastrostomy tube (g-tube) feedings, medication administration, vitals signs, monitoring and assessment and continuous line of sight supervision and nursing interventions during a seizure and CNA visits up to 6 hours daily for assistance with personal care, light housekeeping and continuous line of sight monitoring. Further review of the POC revealed Patient #7 required 24 hour nursing contact. a. The agency failed to ensure the patient received home health services in accordance with their written POC. Specifically, the agency failed to ensure Patient #7 received 24 hour nursing contact. Review of Peds visit notes a.m. (8:00 a.m. through 4:00 p.m.) and p.m. (4:00 p.m. to 8:00 a.m.) dated10/16//21 to 11/9/21 revealed Patient #7 received nursing care 24 hours every day with RN #5 providing the care for the 16 hour p.m. shift. However, Patient #7's six siblings received the same amount of care from RN #5 during each shift. Specifically, during overnight shifts, RN #5 was unable to provide continuous 24 hour contact for Patient #7 while also attending to six siblings residing in three separate bedrooms from Patient #7. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that Patient #7 has one or more seizures a day and required 24 hour care. She further stated Patient #6, #8, #9, #10, #11 and #12 also required 24 hour care. 5. The clinical record for Patient #10 was reviewed on 11/15/21. The POC for the certification periods 9/5/21 through 11/3/21 and 11/4/21 through 1/2/22 revealed a start of care date of 1/8/21; diagnoses included seizures, gastrostomy status, esophageal reflux, atrial septal defect, patent ductus arteriosus, protein-calorie malnutrition, chronic obstructive pulmonary disease, hypoxemia, developmental delays, anisometropia and eczema. POC orders included RN up to 24 times a day for g-tube feedings, medication administration, vital signs, monitoring, assessment, and continuous line of sight supervision and nursing interventions during seizure activity and CNA up to six times a day for assistance with personal care, light housekeeping and continuous line of sight monitoring. Further review of the Plan of Care revealed Patient #10 required 24 hour nursing contact. Review of visit notes a.m. (8:00 a.m. through 4:00 p.m.) and p.m. (4:00 p.m. to 8:00 a.m.) dated 10/16//21 to 11/9/21 revealed Patient #10 received nursing care 24 hours every day with RN #5 providing the care for the 16 hour p.m. shift. However, Patient #10's six siblings received the same amount of care from RN #5 during each shift. Specifically, during overnight shifts, RN #5 was unable to provide continuous 24 hour contact for Patient #10 while also attending to six siblings residing in three separate bedrooms from Patient #10. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that Patient #10 required 24 hour care and so did Patient #6, #7, #8, #9, #11 and #12. 6. The clinical record for Patient #11 was reviewed on 11/08/2021. The POC for the certification period dated 09/05/2021 to 11/03/2021 revealed a start of care date of 01/08/2021; diagnoses included congenital malformation of the skull and face bones, tracheostomy, obstructive sleep apnea, choanal atresia [a narrowing or blockage of the nasal airway that is present from birth], feeding difficulties, gastrostomy, hearing loss, urinary and fecal incontinence. POC orders included RN services for up to 24 hours daily for tracheostomy care, gastrostomy tube (gt) feedings, medication administration, vital signs, monitoring, and assessment, as well as CNA visits up to four and a half hours daily for personal care, light housekeeping, and continuous line of sight monitoring. a) The agency failed to ensure the patient received home health services in accordance with the written POC. Specifically, the agency failed to ensure Patient #11 received 24 hour nursing contact. Review of visit notes a.m. (8:00 a.m. through 4:00 p.m.) and p.m. (4:00 p.m. to 8:00 a.m.) dated 09/05/2021 to 11/03/2021 revealed Patient #11 received nursing care 24 hours every day with RN #5 providing the care for the 16 hour p.m. shift. However, Patient #11's six siblings received the same amount of care from RN #5 during each shift. Specifically, during overnight shifts, RN #5 was unable to provide continuous 24 hour contact for Patient #11 while also attending to six siblings residing in three separate bedrooms. b) The agency failed to ensure pediatric Patient #11 received gastrostomy tube (GT) feedings as ordered by the physician per the POC. Specific skilled nursing interventions related to the GT feedings included: Daytime GT feedings consisting of Compleat Pediatric Organic mixture, 330 milliliters to be delivered over 1 hour through the GT using a feeding pump, 5 times per day at 0800, 1000, 1400, 1800, and 2100, based on the patient's tolerance and mothers discretion. A review of record documentation from 10/14/2021 and 11/03/2021 revealed RN #5 provided skilled nursing care to Patient #11 from 4:00 pm until 8:00 am. RN #5 documented the same narrative note for all 21 shifts and documented between the hours of 4:00 p.m. and 8:00 a.m., the patient received the pediatric feeding blend at 330 milliliters per hour via GT and pump. The RN also documented Patient #11 received the same pediatric feeding blend at 60 milliliters per hour, continuously for 12 hours between 9:00 p.m. to 9:00 a.m., and also received an additional 330 milliliters at 7:00 a.m. During an interview on 11/16/2021 at 1451, when asked to clarify why she was not following the physician’s orders, RN #5 stated there were two orders to choose from and that she could pick which way to run the GT feedings. Review of the clinical record revealed only one gastrostomy tube feeding order noted on the POC and in the clinical record. 7. The clinical record for Patient #12 was reviewed on 11/16/2021. The POC for the certification period dated 09/05/2021 to 11/03/2021 revealed a start of care date of 01/08/2021; diagnoses included feeding difficulties, sleep apnea, gastrostomy, hypothyroidism, supplemental oxygen dependency, developmental disorder, urinary and fecal incontinence. POC orders included RN visits up to 24 hours daily for gastrostomy tube feedings, medication administration, vital signs, monitoring, assessment, supervision at all times during ambulation and seizure activity, as well as CNA visits up to six hours daily for personal care, light housekeeping and continuous line of sight monitoring. a) The agency failed to ensure the patient received home health services in accordance with their written POC. Specifically, the agency failed to ensure Patient #12 received 24 hour nursing contact. Review of visit notes a.m. (8:00 a.m. through 4:00 p.m.) and p.m. (4:00 p.m. to 8:00 a.m.) dated 09/05/2021 to 11/03/2021 revealed Patient #12 received nursing care 24 hours every day with RN #5 providing the care for the 16 hour p.m. shift. However, Patient #12's six siblings received the same amount of care from RN #5 during each shift. Specifically, during overnight shifts, RN #5 was unable to provide continuous 24 hour contact for Patient #12 while also attending to the six siblings residing in three separate bedrooms. Due to continuous care required for the the pediatric patients and the extensive medical needs and fragility of all the patients (Patients #6 through #12) in Home A, each was to have received 24 hour nursing contact and tasks as ordered in their POCs. The agency failed to ensure each patient received home health services and supervision in accordance with their written POC.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure each patient's Plan of Care (POC) covered the patient's status, all pertinent treatments and medications and the frequency and duration of visits for 18 of 18 pediatric patients reviewed receiving private duty nursing (PDN) (Patients #1 through #18). 8. The clinical record for Patient #1 was reviewed on 11/1/21. The POC for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnosis included spastic quadriplegic cerebral palsy, unspecified convulsions, and obstructive sleep apnea. POC orders included SN services up to sixteen hours per day and SN services up to eight hours per day for a total of up to 24 hours per day for gastrostomy tube feedings, medication administration, monitoring, vital signs (VS), and assessments, and CNA services up to five hours per day for assistance with personal cares and light housekeeping. a. The agency failed to ensure Patient #1's POC covered all pertinent treatments and medications. Review of the Plan of Care dated 10/22/21 revealed an order for, "Ibuprofen 100mg/5 ml oral suspension. Give 20 mls (400mg) through g-tube for fever/pain Every 6 hours as needed." However, further review revealed no evidence of parameters for what temperature or pain levels the Ibuprofen is to be given at. Review of the POC dated 10/22/21 revealed orders for, "Give 1065 ml Complete Pediatric Reduced Calorie formula at rate approximately 100 ml/hr overnight. SN to provide daytime enteral feedings consisting [of] Complete Pediatric Reduced calorie formula 125 ml formula mixed with 150 ml water (275 ml total volume) at 8 am, 1200, and 4 pm." However, there were no parameters for checking for residual feedings to ensure the patient was digesting all of their feeding appropriately, and there were no parameters to hold or reduce feedings if the patient showed signs of not tolerating the feedings. Review of the medication list for the time period dated 10/22/21 to 11/1/21 revealed orders for, "Lidocaine Prilocaine 2.5-2.5% Apply small amount over intrathecal pump site monthly 1 hour prior to pump refill Topical," however there is no evidence in Patient #1's record that the patient had an intrathecal pump. During an interview on 11/17/21 at 10:42 a.m., the administrator stated the agency did not have a formal quality assurance (QA) program to catch inaccurate documentation on the POC or in the staff's documentation. She stated any mistakes on the medication administration record (MAR) or the POC should have been reported to the agency to be corrected. She further stated going forward the agency would have a QA nurse to review all of the POCs and staff documentation for errors and accuracy. Similar findings of failure to ensure the patient's POC covered all pertinent treatments and medications were found for Patients #2, #3, #4, and #5. 5. The clinical record for Patient #16 was reviewed on 11/8/21. The POC for the certification period dated 10/10 to 12/8/21 revealed a start of care date of 12/14/20; diagnoses included bronchopulmonary dysplasia, congenital malformations of respiratory system, chronic respiratory failure, dependence on ventilator, trach status and gastrostomy status. POC orders included RN to provide around the clock care to include medication administration, g-tube feedings and associated care, chest physiotherapy (CPT) three times daily, maintain ventilator during overnight only, trach care, suctioning twice daily, monitoring and assessment. a) The agency failed to ensure Patient #16's POC included the frequency and duration of RN visits. Review of the POC for the period dated 10/10 to 12/8/21 revealed no frequency or duration of visits to be performed by the RN, however, the RN was ordered to provide the specific interventions listed above. 6. The clinical record for Patient #15 was reviewed on 11/8/21. The POC for the certification period dated 9/24 to 11/22/21 revealed a start of care date of 7/31/20; diagnoses included spastic quadriplegic cerebral palsy, epilepsy, neuromuscular scoliosis, chronic respiratory failure and gastrostomy status. POC orders included RN visits up to 24 hours per day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment and CNA visits up to six hours daily for personal care, light housekeeping and continuous line of sight monitoring. a) The agency failed to ensure Patient #15's Plan of Care included documentation of caregiver and psychosocial statuses. Further review of the POC for the period dated 9/24 to 11/22/21 revealed the caregiver and psychosocial status sections were documented as "there is no data for this section." 7. The clinical record for Pediatric Patient #18 was reviewed on 11/3/21. The POC for the certification period dated 9/16 to 11/14/21 revealed a start of care date of 9/16/21; diagnoses included failure to thrive, non-traumatic intracerebral hemorrhage, convulsions and gastrostomy status. POC orders included RN visits up to 24 hours a day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment. a) The agency failed to ensure Patient #18's POC included documentation of advanced directives, caregiver and psychosocial statuses. Further review of the POC for the period dated 9/16 to 11/14/21 revealed the advanced directive, caregiver and psychosocial status sections were documented as "there is no data for this section." During an interview on 11/17/21 at 10:42 a.m., the DON stated plans of care had not been accurately documented to include all the pertinent information required. The DON further stated she had taken a step back in her responsibilities and the quality assurance of the plans of care had not occurred. 4. The clinical record for Patient #12 was reviewed on 11/16/2021. The POC for the certification period dated 09/05/2021 to 11/03/2021 revealed a start of care date of 01/08/2021; diagnoses included feeding difficulties, sleep apnea, gastrostomy, hypothyroidism, supplemental oxygen dependency, developmental disorder, urinary and fecal incontinence. POC orders included RN visits up to 24 hours daily for gastrostomy tube (GT) feedings, medication administration, vital signs, monitoring, assessment, supervision at all times during ambulation and seizure activity, as well as CNA visits up to six hours daily, for personal care, light housekeeping and continuous line of sight monitoring. a) The agency failed to ensure that Patient #12's POC contained all pertinent diagnoses. Specifically, The agency failed to ensure Patient #12's POC included a seizure disorder diagnosis. Review of visit notes dated from 10/04/2021 to 11/03/2021 completed by RN #5 revealed Patient #12 experienced seizures, which were almost daily. In addition, she was also on prescribed medications for her seizures that included, Vimpat, 50mg two times daily through the GT and Midazolam 5mg per 1ml, 2mls into the patients nares, as needed for seizures lasting longer than 5 minutes. During an interview on 11/04/2021 at 9:00 AM, RN #5 stated that Patient #12 had frequent seizure activity and was often home from school as a result. Findings include: AGENCY POLICY According to the agency policy titled, "Physician Role in Home Care of Patients Plan of Care (POC) and Interim Orders," dated 2007 (in pertinent parts): "Plan of Care 1. The POC is developed in consultation with staff, patient, physician and other providers involved in the patient's care. The POC includes: a) Patient's primary and secondary diagnoses b) Food or drug allergies c) Homebound status d) Goals/outcomes to be achieved e) Patient's mental status f) Functional limitations g) Activities permitted h) Safety measures to protect against injury i) Nutritional requirements j) Medications and treatments k) Specific procedures/treatments to be performed, including amount, frequency and duration l) Supplies and equipment required m) Discharge or referral plan n) Frequency and duration of visits o) Prognosis p) Rehabilitation potential q) Other appropriate items such as precautions and contraindications" 1. The clinical record for Patient #7 was reviewed on 11/8/21. The POC for the certification period dated 10/16/21 to 12/14/21 revealed a start of care date of 10/16/21; diagnoses included hypoxic ischemic encephalopathy, anoxic brain damage, cortical blindness, gastrostomy status, congenital hypertonia, and lack of expected normal physiological development in childhood, disorders of muscle, elevation of levels of lactic acid dehydrogenase, feeding difficulties, urinary incontinence, full incontinence of feces, sedative, hypnotic, anxiolytic dependence with withdrawal, need for assistance with personal care, personal history of urinary calculi, and global developmental delays POC orders included registered nurse (RN) visits up to 24 hours daily for gastrostomy tube (g-tube) feedings, medication administration, vitals signs, monitoring and assessment, continuous line of sight supervision, nursing interventions during a seizure and Certified Nursing Aide (CNA) visits up to 6 hours for assistance with personal care, light housekeeping and continuous line of sight monitoring. a. The agency failed to ensure accurate frequency of RN services to be provided was on the POC. Review of the POC dated 10/16/21 to 12/14/21 revealed Employee #1 documented under the Caregiver Status, "RN/LPN up to 24 hours/day 7 days/week". Further review of the POC revealed Employee #1 documented under Orders for Discipline and Treatment, "RN/LPN 16 x day for 60 days and RN/LPN 8 x day for 60 days." Under Hospitalization/Emergency Room Visit Risk Interventions she documented "Establish emergency plan and instructions for 24 hour contact." It was unclear whether Patient #7 required 24 hour care or if she required less than 24 hour care as stated under the Caregiver Status section (up to 24 hours/day 7 days/week). Review of the clinical record dated 10/16/21 to 11/10/21 revealed the agency nurses documented one eight hour shift during the day from 8:00 a.m. to 4:00 p.m. and one 16 hour shift during the night from 4:00 p.m. to 8:00 a.m. every day, totaling 24 hours of care every day. b. The agency failed to ensure that Patient #7's POC contained all pertinent diagnoses. Review of visit notes for Patient #7 dated 10/16/21 to 10/30/21 revealed Patient # 7 experienced intermittent seizures 14 times during the p.m. (4:00 p.m. to 8:00 a.m.) shift as documented by RN #5. The agency failed to ensure Patient #7's POC included a seizure disorder diagnosis. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that Patient #7 had one or more seizures a day and she had never had to administer Patient #7's rescue seizure medication (Midazolam to be given for seizures lasting greater than 5 minutes) as his seizures did not last that long. 2. The clinical record for Patient #8 was reviewed on 11/8/21. The POC for the certification period 9/19/21 to 11/17/21 revealed a start of care date of 5/27/20; diagnoses included dependence on renal dialysis, dysphagia, anemia in chronic kidney disease, unspecified lack of expected normal physiological development in childhood and congenital hypothyroidism. POC orders included RN/licensed practical nurse (LPN) up to 24 hours a day for peritoneal dialysis, gastrostomy tube feedings, medication administration, vitals, monitoring and assessment; and CNA up to six times a day for assistance with personal care and light housekeeping. a. The agency failed to ensure accurate frequency of RN services to be provided was listed on the POC. Review of the Plan of Care dated 9/19/21 to 11/17/21 revealed Employee #1 documented under the Caregiver Status, "RN/LPN up to 24 hours/day". Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatment, "RN/LPN 16 x day for 60 days and RN/LPN 8 x day for 60 days" and under Hospitalization/Emergency Room Visit Risk Interventions she documented "Establish emergency plan and instructions for 24 hour contact." It was unclear whether Patient #7 required 24 hour care or if she required less than 24 hour care as stated under the Caregiver Status section (up to 24 hours/day 7 days/week). Review of the clinical record dated 10/10/21 to 11/3/21 revealed the agency nurses were documenting one eight hour shift during the day from 8:00 a.m. to 4:00 p.m. and one 16 hour shift during the night from 4:00 p.m. to 8:00 a.m. totaling 24 hours of care every day. b. The agency failed to ensure all supplies required for peritoneal dialysis (PD) were listed on Patient #8's POC. Review of the POC dated 10/10/21 to 11/3/21 revealed Employee #1 documented under Genitourinary Interventions that Patient #8 was to receive daily PD with delivery system of continuous cycling peritoneal dialysis/ intermittent peritoneal dialysis, mode low fill, total dialysis volume 3400ml therapy time 11 hours, total fill 300 ml (33ml/kg/fill) last fill 100 ml, cycles 11 and final dextrose concentration 2%. Employee #1 failed to provide information on what solution bags were being used for the dialysis. c. The agency failed to ensure an accurate Levothyroxine dose and instruction was listed on Patient #8's POC. Review of the POC dated 10/10/21 to 11/3/21 completed by Employee #1 revealed Patient #8 was to receive Levothyroxine (a thyroid medication) 0.100mg (1000 mcg) daily feeding tube. Review of "After Visit Summaries" dated 10/4/21 and 11/1/21 provided by the foster mother of the child (RN #5) to the agency, revealed Patient #8 Levothyroxine dosage as 100 mcg to be given once a day by g-tube by crushing the tab and mixing it with water. Review of the medication administration record (MAR) for Patient #8 revealed RN #5 documented providing 1000 mcg of Levothyroxine every day in October and 11/1/21 to 11/9/21. During an interview on 11/16/21 at 6:12 p.m., RN #14, who completes recertifications for Patient #8, reviewed Patient #8's October and November 2021 MAR and the POC for certification period 9/19/21 to 11/17/21 and stated the dosage listed of Levothyroxine as 1000 mcg is inaccurate. RN #14 confirmed that Patient #8 was prescribed 100 mcg. RN #14 stated the dosage of 100mcg was on Patient #8's Levothyroxine bottle but acknowledge the potential was there if a fill in nurse looked at the dosage on the MAR and POC, that Patient #8 could have accidentally been administered ten times the dosage of her ordered Levothyroxine. d. The agency failed to ensure the use of a suction a machine and orders for the use of the suction machine was on Patient #8's POC. Review of the POC for Patient #8 with certification period 9/19/21 to 11/17/21 lists her durable medical equipment as follows: "pump bags, pump, clamp, charger, IV pole, 60 ml cath tip syringe, 10 ml syringe, ½ inch hy-tape, formula, back pack, 2x2 split gauze, extension sets, back up gt [gastrostomy] button, 2 foley catheters, 2 gravity bags(for emergencies), additional 15mls of formula per feed required to prime tubing, oxygen, oxygen tubing, pulse oximeter, scale, peritoneal dialysis machine, crib, O2 [oxygen] concentrator, oxygen tubing, infant car seat, stroller, blood pressure cuff, O2 concentrator, oxygen tubing, infant car seat, stroller, blood pressure cuff, bath chair, feeding chair, swing, Zflow pillow, surgical mask and gowns." The agency failed to ensure the suction machine used daily with Patient #8 was listed on her POC. Further review of the Plan of Care stated under Respiratory Interventions: "assess respiratory status and report s/s [signs/symptoms] of respiratory infection; instruct caregiver on proper care of oxygen equipment and safety measures related to; report signs of respiratory distress/oxygen deprivation; perform SPO2 [oxygen saturation measurement] 4 x daily; Instruct/perform application of 0.25 liters of oxygen for oxygen saturation Review of visit notes for Patient #8 dated for the p.m. (4:00 p.m. to 8:00 p.m.) shift revealed that Patient #8 had been provided with nasal suctioning 16 times by RN #5. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that she used a suction machine to provide nasal suction to Patient #8 as needed, and Patient #8 had a suction machine since RN#5, her foster mother, had started caring for Patient #8. 3. The clinical record for Patient #10 was reviewed on 11/15/21. The POC for the certification periods 9/5/21 through 11/3/21 and 11/4/21 through 1/2/22 revealed a start of care date of 1/8/21; diagnoses included seizures, gastrostomy status, esophageal reflux, atrial septal defect, patent ductus arteriosus, protein-calorie malnutrition, chronic obstructive pulmonary disease, hypoxemia, developmental delays, anisometropia and eczema. POC orders included RN up to 24 times a day for g-tube feedings, medication administration, vital signs, monitoring, assessment, and continuous line of sight supervision and nursing interventions during seizure activity and CNA up to six times a day for assistance with personal care, light housekeeping and continuous line of sight monitoring. a. The agency failed to ensure accurate frequency of RN services to be provided were listed on the POC. Review of the POC dated 9/5/21 to 11/3/21 and 11/4/21 to 1/2/22 revealed Employee #1 documented under the Caregiver Status, "RN up to 24 hours/day". Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatment, "RN up to 16 hours a day for 60 days and RN up to 8 hours a day for 60 days." and under Hospitalization/Emergency Room Visit Interventions she documented "Establish emergency plan and instructions for 24 hour contact." However, it was unclear whether Patient #8 required 24 hour care or if she required less care than 24 hour care as stated under the Caregiver Status section (up to 24 hours/day 7 days/week) Review of the clinical record dated 9/5/21 to 11/13/21, revealed the agency nurses were documenting one eight hour shift during the day from 8:00 a.m. to 4:00 p.m. and one 16 hour shift during the night from 4:00 p.m. to 8:00 a.m. totaling 24 hours of care every day. However, from the POC it is unclear whether Patient #8 was supposed to receive 24 hour care or whether the patient would receive 24 hour care only when it was necessary. During an interview on 11/17/21 at 10:42 a.m., the DON stated that she had taken a step back from tasks in the agency this past year due to various personal reasons and the quality assurance checks that she normally would have done were not done when she had decreased her hours. The DON stated the agency needed to improve the oversight of documentation and the DON had already begun in-servicing the staff on the importance of writing and completing an accurate note. The DON stated the agency planned to hire a quality assurance nurse to help get the agency back on track especially with documentation, POCs and assessments.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to implement a quality assessment and performance improvement (QAPI) which evaluated all agency services and complied with the requirements and standards set forth in CFR 484.65. The failure created the potential for the agency to overlook trends which affected the quality of services and care provided to its patients and put patients' safety at risk. Findings include: AGENCY POLICY According to agency policy titled, "Quality Management Part 3," undated, (in pertinent parts): “Every licensed or certified facility...shall establish a quality management program (QMP) appropriate to the size and type of facility that evaluates the quality of client or resident care and safety, and that complies with this part 3”. According to the agency policy titled, "Performance Improvement (PI)," 05/2014 (in pertinent parts); "Performance Improvement can be defined as the measurement of the output/outcomes of particulate processes and/or procedures with planned modification of the process or procedure in order to increase the output, efficiency or effectiveness... When used most effectively, it is a strategy involving all levels of an organization. All members of the organization are expected and encouraged to participate in performance improvement activities. (Including the Governing Body, Professional Advisory Committee, and clinical and office staff.) A Performance Improvement Committee will be appointed as a subcommittee of the Professional Advisory Committee. Membership will include the DCS [Director of Clinical Services] as chair and representation from all disciplines providing services to agency patients... Performance Improvement Teams will be appointed to investigate and make recommendations to resolve specific problems; Components of the PI program include… OASIS Adverse Events and OBQI/QM reports provide ideal areas of study. Written Satisfaction surveys A Quarterly clinical record reviews Risk Management Activities Staff Competency and Performance Evaluation Annual agency evaluation” During an interview on 11/01/2021 at 10:35, the agency Administrator #1 stated she was responsible for ensuring the agency maintained an active quality management program, including all QAPI elements. Upon request to review all QAPI documentation, the administrator stated the agency kept all QAPI documents in a binder, however, they did not have any QAPI documentation to reflect on agency activities because it had been removed by another governmental agency in September 2020. She went on to state she believed she would be able to locate some of the past documents online and that all of her stuff was a “little bit of everywhere”. On 11/02/21, Administrator #1 provided a binder and stated it was to represent the QMP [QAPI]. Review of the binder documentation showed details of how to establish a QAPI, however, it did not contain any documents that were specific to the agency or any agency QAPI activities. Later that afternoon on 11/02/21, Administrator #1 was able to locate previous Governing Board meeting minutes that reflected they had met on 9/1/20, 9/30/20, 10/5/20, 12/1/20, 5/11/21, and 9/10/21, however, upon review of the meeting minutes, there was no evidence any QAPI activities had ever been discussed. The administrator stated she went through everything she could, including boxes and charts sitting on shelves but was unable to locate any further documents, and stated she would continue to look to see what she could find. Throughout the course of the survey, repeated requests were made for any further documentation consisting of the required QAPI elements, however, no further evidence was presented. During a final interview with Administrator #1 and the director of nursing (DON #2) on 11/17/21 at 10:40 AM, the administrator acknowledged it was her responsibility to maintain an active QAPI program and should have had better documentation established since the other government agency had removed the material in September of 2020. She further acknowledged she should have kept a backup of all documents and will do so moving forward. In summary, the agency failed to ensure they had implemented and maintained a quality assessment and performance improvement (QAPI) which evaluated all agency services and complied with the requirements and standards set forth in CFR 484.65.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on the nature and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 484.75, SKILLED PROFESSIONAL SERVICES, was out of compliance. A total of 22 clinical records were reviewed for compliance with the Condition and Standards for Skilled Professional Services. A complaint investigation #CO28023 was initiated on 11/1/21 and revealed the agency failed to ensure registered nurses (RNs) routinely assessed a patient who received peritoneal dialysis (PD) and complained of abdominal pain. Furthermore, the agency failed to ensure RN's coordinated with the physician and documented an accurate and complete description of care provided. These failures resulted in the potential for harm to all patients served by the agency. Specifically: G706 - Standard: Interdisciplinary Assessment of the Patient - The agency failed to ensure ongoing interdisciplinary assessment occurred by the RN to re-evaluate the nursing needs for 1 of 1 pediatric patients receiving PD. G716 - Standard: Preparing Clinical Notes - The agency failed to ensure staff provided complete and accurate clinical notes for 18 of 18 PDN patient records reviewed . G718 - Standard: Communication with physicians - The agency failed to ensure nursing professional services communicated with the physician of changes in condition for 1 of 18 pediatric patients (Patient #8) and the agency failed to ensure nursing professional services communicated with the physician to obtain orders for changes to the Plan of Care for 7 of 18 pediatric patients reviewed receiving PDN.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure ongoing interdisciplinary assessment occurred by the Registered Nurse (RN) to re-evaluate the nursing needs for 1 of 1 pediatric patients receiving peritoneal dialysis (PD) (Patient #8). Findings include: The clinical record for Patient #8 was reviewed on 11/8/21. The Plan of Care (POC) for the certification period 9/19/21 to 11/17/21 revealed a start of care date of 5/27/20; diagnoses included dependence on renal dialysis, dysphagia, anemia in chronic kidney disease, unspecified lack of expected normal physiological development in childhood and congenital hypothyroidism. Plan of Care orders included RN/licensed practical nurse (LPN) up to 24 hours a day private duty nursing (PDN) for peritoneal dialysis, gastrostomy tube feedings, medication administration, vitals, monitoring and assessment; and certified nursing aide (CNA) up to six times a day for assistance with personal care and light housekeeping. Review of the POC for the certification period 9/19/21 to 11/17/21 revealed Patient #8 was to receive daily PD with a delivery system of continuous cycling peritoneal dialysis for eleven hours daily. Patient #8 was to receive a dressing change at her PD catheter site every one to two days or if it became wet, soiled or came off. The orders for the dressing change included "use a sterile technique and while masked: remove soiled dressing, cleanse the site with Exsept (a wound care cleaner), leave crusts or scabs in place to heal, apply gentamicin (an antibiotic ointment) as needed, place a new secure dressing to the site". a) The agency RNs failed to perform complete re-assessments and re-evaluation of Patient #8's symptoms and failed to communicate potential signs and symptoms of a PD site infection or peritonitis to the PD Clinic. Review of a document titled "G-tube and PD Catheter Care", dated 6/2/20 showed exit site infections at the PD catheter were possible with the symptoms including redness, swelling, pain at the exit site and/or drainage/pus from the exit site. The document then provided instructions if these symptoms were noted to call the PD nurse immediately and if it was a night, weekend, or holiday to call the dialysis nurse on call, obtain a culture, and start antibiotics and antifungal medications as directed by the nurse. Review of the "After Visit Summary" dated 10/4/21 and 11/1/21 showed RN #5 (the foster mother of the patient), documented "call the PD Nurse Line or on-call nurse with any sign of peritonitis (inflammation of the membrane lining the abdominal wall and covering the abdominal organs, usually infectious and often life-threatening) with the following examples of symptoms: fever, chills, abdominal pain, irritability, abdominal swelling, full or distended abdomen, cloudy PD drainage, lower back pain, nauseous and vomiting, fibrin (white strands) in the PD drainage, low drain alarms, or constipation." Review of a Ped visit note completed on 10/26/21 by RN # 4 for 8:00 a.m. to 4:00 p.m. shift revealed RN #4 documented Patient #8's PD catheter site was clean, dry and intact, and PD catheter site care was provided. RN # 4 documented cleaning the gastrostomy-jejunostomy (GJ) tube site, changing the dressing and the technique she used which followed the plan of care orders. At 4:00 p.m. RN #4 documented patient had no signs or symptoms of distress or discomfort at that time and that Patient #8 was observed to grab her GJ tube site several times and complained of pain. RN #4 noted she assessed the GJ tube site several times and no changes or concerns were noted. However, RN #4 failed to document if she assessed Patient #8's PD site after the patient complained of abdominal pain. RN #4 stated the mother of Patient #8 (RN #5) was notified of Patient #8's complaints of pain. Further review of Pediatric Patient #8's chart failed to show evidence that RN #4 communicated with Patient #8's medical doctor (MD) or the PD clinic to inform them of Patient #8's symptom of abdominal pain, a potential sign of peritonitis. Review of a Ped visit note completed on 10/26/21 for 4:00 p.m. to 8:00 a.m. shift by RN #5 revealed RN #5 documented Patient #8 was crying on and off and her PD catheter site was red but no discharge was noted. GT dressing clean, dry and intact. RN #5 documented Patient #8's abdomen appeared to be distended but was soft and Patient #8 was without signs or symptoms of pain with palpation. RN #5 documented that PD ran from 9:00 p.m. to 5:00 a.m. RN #5 also then documented at 8:00 a.m. that Patient #8 was free of signs or symptoms of distress or discomfort. RN #5 documented on the medical administration record (MAR) that she applied gentamicin 0.1% topical cream to the PD site at 8:00 a.m. on 10/27/21. RN #5 documented that Patient #8 received PD from 9:00 p.m. to 5:00 a.m. and RN #5 failed to document the appearance of post dialysis drainage fluid. Further review of the patient's record revealed no evidence RN #5 communicated with Patient #8's MD or the PD clinic to inform them of Patient #8's symptoms of a red PD site, a sign of a potential PD site infection, and her symptoms of irritability and distended abdomen, signs of a potential peritonitis. Review of a Ped visit note completed on 10/27/21 for the 8:00 a.m. to 4:00 p.m. shift by RN #4 revealed RN #4 documented she received report from RN #5. RN #4 documented Patient #8's PD catheter site was clean, dry and intact and GJ tube dressing was clean, dry and intact. RN #4 documented she cleaned the GJ tube site and changed the GJ tube dressing and the technique she used. RN #4 stated Patient #8 was free of signs and symptoms of distress and discomfort. Review of a Ped visit note completed on 10/27/21 for the 4:00 p.m. to 8:00 a.m. shift by RN #5 revealed RN #5 documented Patient #8 was crying on and off and her PD catheter site was red but no discharge was noted. GJ tube dressing clean, dry and intact. RN #5 documented Patient #8's abdomen appeared to be distended but was soft and Patient #8 was without signs or symptoms of pain with palpation. RN #5 also documented at 8:00 a.m. Patient #8 was free of signs of symptoms of distress or discomfort. Review of the MAR revealed RN #5 did not apply gentamicin 0.1% topical cream to the PD site on 10/28/21. RN #5 documented that Patient #8 received dialysis from 9:00 p.m. to 5:00 a.m. and RN #5 failed to document the appearance of post dialysis drainage fluid. Further review failed to show evidence RN #5 had communicated with Patient #8's MD or the PD clinic to inform them of Patient #8's symptoms of a red PD site, a sign of a potential PD site infection, and her symptoms of irritability and distended abdomen, signs of a potential peritonitis. A Ped Visit note completed on 10/28/21 for the 8:00 a.m. to 4:00 p.m. shift by RN #4 revealed RN #4 documented Patient #8's PD catheter site was clean, dry and intact. RN #4 documented under interventions that PD catheter site care was provided. At 4:00 p.m. RN #4 documented Patient #8 had no signs or symptoms of distress or discomfort at that time but in the next sentence she documented Patient #8 was observed to grab her GJ tube site several times and complained of pain when standing. RN #4 failed to assess Patient #8's PD site after the patient complained of abdominal pain. RN #4 documented RN #5 was notified of Patient #8's complaints of pain. However, further review of Patient #8's chart failed to show evidence that RN #4 communicated with Patient #8's MD or the PD clinic to inform them of Patient #8's symptom of abdominal pain, a potential sign of peritonitis. Review of a Ped Visit note completed on 10/28/21 for the 4:00 p.m. to 8:00 a.m. shift by RN #5 revealed RN #5 documented Patient #8 had abdominal pain with RN #5 documenting Patient #8's pain level as a five. RN #5 failed to provide the scale for this pain rating in her note and did not indicate what pain tool she used to determine Patient #8's pain level. RN #5 documented Patient #8 was holding her left side, was "very pale", heart rate of 150 beats per minute (bpm), and her abdomen appeared distended but was soft and Patient #8 was without signs or symptoms of pain with palpation. RN #5 documented that Patient #8's PD catheter site was "red intact" and her GJ tube dressing was clean, dry and intact. RN #5 documented that Patient #8 was afebrile and free of signs or symptoms of infection. RN #5 documented that she performed PD catheter care in the intervention section of her note. RN #5 documented on the MAR that she applied gentamicin 0.1% topical cream during a dressing change for the PD site at 8:00 a.m. on 10/29/21. RN #5 documented Patient #8 received dialysis from 9:00 p.m. to 5:00 a.m. and failed to document the post dialysis drainage fluid appearance. Further review of Patient #8 record failed to show evidence RN #5 had communicated with Pediatric Patient #8's MD or the PD clinic to inform them of Patient #8's symptoms of a red PD site, a sign of a potential PD site infection, and her symptoms of abdominal pain and distended abdomen, signs of a potential peritonitis. A Ped visit note completed on 10/29/21 for the 8:00 a.m. to 4:00 p.m. shift by RN #4 revealed RN #4 documented at 8:00 a.m. that she received a report from RN #5, completed her initial assessment of Patient #8 and had no signs or symptoms of distress or discomfort. RN #4 documented Patient #8's PD catheter site was clean, dry and intact and GJ tube dressing clean, dry and intact. RN #4 then documented that Patient #8 continued to grab at GJ tube site and complained of pain, HR was elevated to 150 bpm, and RN #4 administered as needed (PRN) Tylenol at 9:00 a.m. per the MAR. RN #4 then documented that the foster mother of the child (RN #5) was aware and MD notified, this was three days after Patient #8 began to show signs and symptoms of a potential PD site infection and/or peritonitis. Review of a Ped visit note completed on 10/29/21 by RN #5 for 4:00 p.m. to 8:00 a.m. shift revealed RN #5 documented that pictures of Patient #8's PD site and abdomen were sent to the PD clinic. RN #5 documented she informed the PD clinic of Patient #8's pain via an internet based application used by the PD clinic. In the email communication to the PD clinic, RN #5 described Patient #8's bowel movement frequency had increased and Patient #8 was gassy so RN #5 decreased the dosage of her Miralax (a laxative medicine used to treat occasional constipation) and planned to stop using the Miralax as of 10/30/21. RN #5 described Patient #8 as "dramatic" at times. The PD clinic nurse responded to RN #5 with an email on 10/29/21 at 12:09 p.m. instructing RN #5 to loop the PD catheter on top of the dressing, if RN #5 was not already using this technique, as the PD clinic RN felt Patient #8's PD catheter exit site looked enlarged and any little movement could cause enlargement of this site. Additionally the PD clinic RN stated Patient #8's pain could be coming from the slightly enlarged site or with the increased stool, perhaps from her colon. The PD clinic nurse was in agreement to decrease Miralax slowly as perhaps Patient #8 had developed a GI virus and the PD clinic RN reminded RN #5 to make sure Patient #8 had at least one soft stool a day. Additionally the PD clinic RN reminded RN #5 of the signs of peritonitis to watch for: cloudy PD drainage, abdominal pain, fever, chills, lower back pain, nausea or vomiting, fibrin, low drain alarms, full/distended abdomen, and constipation. The PD clinic MD responded to RN #5 in an email on 10/29/21 at 2:21 p.m. agreeing with the PD clinic RN's advice and reiterated to RN #5 if Patient #8 had any of the warning signs of peritonitis or if Patient #8 did not improve to inform the PD clinic. Review of a Ped visit note dated 10/30/21 completed by RN #5 for the 4:00 p.m. to 8:00 a.m. shift revealed RN #5 documented that Patient #8 had abdominal pain and RN #5 documented the pain at level five. RN #5 failed to provide the scale for this pain rating in her note and did not indicate what pain tool she used to determine Patient #8's pain level. RN #5 documented the Patient #8 complained of pain all day. RN #5 documented in the body of her note that she administered Tylenol for pain. RN #5 documented that Patient #8's abdomen was distended but soft and without signs or symptoms of pain with palpation. RN #5 documented that Patient #8's PD catheter site was red, slightly moist and intact. Further review of Patient #8's record failed to show evidence RN #5 communicated with Patient #8's MD or the PD clinic to inform them of Patient #8's symptoms of a red and moist PD site, a sign of a potential PD site infection, and her symptoms of abdominal pain and distended abdomen, signs of a potential peritonitis. A Ped visit note dated 10/31/21 completed by RN #5 for the 4:00 p.m. to 8:00 a.m. shift revealed RN #5 documented that Patient #8 heart rate was 150 bpm, that Patient #8 had abdominal pain and RN #5 documented the pain at level five. RN #5 documented Patient #8 complained of pain all day. RN #5 documented in the body of her note that she administered Tylenol for pain. RN #5 documented that Patient #8's abdomen was distended but soft and without signs or symptoms of pain with palpation. RN #5 documented that Patient #8's PD catheter site was red, slightly moist and intact. Further review of Pediatric Patient #8's record failed to show evidence RN #5 communicated with Pediatric Patient #8's MD or the PD clinic to inform them of Pediatric Patient #8's symptoms of a red and moist PD site, a sign of a potential PD site infection, and her symptoms of abdominal pain and distended abdomen, signs of a potential peritonitis. Review of a Ped visit note dated 11/1/21 completed by RN #5 for the 4:00 p.m. to 8:00 a.m. shift showed documentation Patient #8 was seen by the PD clinic for a regularly scheduled appointment and due to Patient #8 not feeling well. RN #5 documented that Patient #8's PD site dressing was changed in the PD clinic and pus was noted around the PD catheter. Cultures were taken by the PD clinic RN and Patient #8 was started on an antibiotic and nystatin (an antifungal). RN #5 documented in the infection control section of her note that Patient #8 had a new infection. Record review showed the RNs repeatedly failed to appropriately assess and address Patient #8's progressive symptoms of pain timely and failed to direct the coordination of the patient's care with the PD clinic and the physician. A Ped visit note dated 11/2/21 completed by RN #5 for the 4:00 p.m. to 8:00 a.m. shift showed RN #5 documented that Patient #8 had a PD line infection and was on antibiotics. During an interview on 11/9/21 at 11:32 a.m., RN #3 stated that she could not recall if Patient #8 had any pain during her shift on 10/31/21 but she did recall RN #5 reported to her that Patient #8 complained of pain. RN #3 stated after Patient #8 was seen by the PD clinic doctor, Patient #8 was placed on a 21 day course of antibiotics and Patient #8 had further changes in her orders which included increasing her frequency of baths from once every other day to daily and RN #5 was instructed to change the PD site dressing daily. During an interview on 11/9/21 at 12:27 p.m. RN #4 confirmed on10/26/21 she observed Patient #8 grabbing at her GJ tube site and this led RN #4 to assess the GJ tube site as Patient #8 had a granuloma (small area of inflammation) at the GJ tube site. RN #4 stated she felt the pain could be coming from that site. RN #4 stated that she informed RN #5 of Patient #8's complaints of pain and RN #4 stated RN #5 called the doctor but she could not recall the timeline on when the phone call was made. RN #4 stated she would have called the doctor if RN #5 had not called the doctor. RN #4 stated due to RN #5 also being Patient #8's foster mother, RN #5 asked the other RNs caring for Patient #8 to inform RN #5 of any changes of conditions with Patient #8. Further, RN #4 stated RN #5 normally took on the responsibility to inform the doctor about changes of condition. RN #4 stated that she did not change the PD site dressing or assess under the dressing as RN #5 would complete this task for Patient #8. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated prior to the 11/1/21 PD clinic MD visit dressing changes were being done by RN #5 once every other day. RN #5 stated she did not recall when she first notified the MD of Patient #8's red PD site or abdominal pain but RN #5 felt it was before 10/31/21. RN #5 did not recall documenting that Patient #8 had a pain level of 5 so she could not provide what scale she used to document that pain level. RN #5 stated when Patient #8 was assessed in the PD clinic Patient #8's PD site had a little bit of drainage that looked different. The PD clinic put Patient #8 on antibiotics prophylactically and asked RN #5 to change the PD site daily.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on interviews and clinical record reviews, the agency failed to ensure staff provided complete and accurate clinical notes for 18 of 18 PDN patient records reviewed (Pediatric Patients #1 through #18). 10. The clinical record for Patient #1 was reviewed on 11/1/21. The Plan of Care for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnosis included spastic quadriplegic cerebral palsy, unspecified convulsions, and obstructive sleep apnea. Plan of Care orders included skilled nursing (SN) services up to sixteen hours per day and SN services up to eight hours per day for a total of up to 24 hours per day for gastrostomy tube feedings, medication administration, monitoring, vital signs (VS), and assessments, and certified nurse aide (CNA) services up to five hours per day for assistance with personal cares and light housekeeping. a. The agency failed to ensure nursing staff prepared complete and accurate clinical notes for their patients. Review of the Plan of Care dated 10/22/21 to 12/20/21, revealed Employee #1 documented under Caregiver Status, "RN/LPN up to 24 hours/day 7 days/wk." Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatments, "RN/LPN up to 16 hours per day and RN/LPN up to 8 hours per day," and under Hospitalization/Emergency Room Visit Risk Interventions she documented, "Establish emergency plan and instructions for 24 hour contact." However, it is unclear whether Patient #1 requires 24 hour care or if they require less than 24 hours care. Review of the Plan of Care dated 10/22/21 to 12/20/21 revealed orders for, "Lidocaine Prilocaine 2.5-2.5% Apply small amount over intrathecal pump site Monthly 1 hour prior to pump refill Topical." However there was no evidence in Patient #1's record that the patient had an intrathecal pump. 11. The clinical record for Patient #2 was reviewed on 11/3/21. The Plan of Care for the certification period dated 10/10/21 to 12/8/21 revealed a start of care date of 6/17/20; diagnosis included spastic quadriplegic cerebral palsy, disorders of the lung, encephaolpathy, epilepsy, hypoxemia, and feeding difficulties. Plan of care orders included SN services up to sixteen hours per day for one hour for nine weeks and up to eight hours per day for one hour for nine weeks for tracheostomy and ventilator care, gastric tube (GT) feedings, vital signs, monitoring, and assessments, and CNA services up to seven times a day for nine weeks to assist with personal care and light housekeeping. a. The agency failed to ensure nursing staff prepared complete and accurate clinical notes for their patients. Review of the Plan of Care dated 10/10/21 to 12/8/21 revealed Employee #1 documented under Caregiver Status, "RN/LPN up to 24 hours/day 7 days/wk." Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatments, "RN up to 16 x day x 9 weeks, 1hr duration and RN up to 8 x day x 9 weeks, 1hr duration," and under Hospitalization/Emergency Room Visit Risk Interventions she documented, "Establish emergency plan and instructions for 24 hour contact." However, it is unclear whether Patient #2 requires 24 hour care or if they require less than 24 hour care. Review of the clinical record dated 10/10/21 to 11/3/21 revealed the agency nurses were documenting one eight hour shift during the day from 8:00 a.m. to 4:00 p.m. and one 16 hour shift during the night from 4:00 p.m. to 8:00 a.m. totalling 24 hours of care every day. However, from the Plan of Care it is unclear whether the patient was supposed to receive 24 hour care or whether the patient would receive 24 hour care only when it was necessary. 12. The clinical record for Patient #3 was reviewed on 11/2/21. The Plan of Care for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnosis included post traumatic seizures, hemiplegia (paralysis of one side of the body), and a gastrostomy tube (G-tube). Plan of care orders included SN services up to 24 hours a day for 60 days for g-tube feedings, medication administration, vital signs, monitoring, and assessments, and CNA services up to six hours a day for 60 days for assistance with personal care and light housekeeping. a. The agency failed to ensure nursing staff prepared complete and accurate clinical notes for their patients. Review of the Plan of Care dated 10/22/21 to 12/20/21 revealed Employee #1 documented under Caregiver Status, "RN/LPN up to 24 hours/day 7 days/wk." Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatments, "RN/LPN up to 24 hours per day x 60 days," and under Hospitalization/Emergency Room Visit Risk Interventions she documented, "Establish emergency plan and instructions for 24 hour contact." However, it is unclear whether Patient #3 requires 24 hour care or if they require less care. 13. The clinical record for Patient #4 was reviewed on 11/8/21. The Plan of Care for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnosis included intracranial hemorrhage (bleeding in the brain), gastrostomy tube, autism, and developmental delays of speech and language. Plan of Care orders included SN services up to 24 hours per day for 60 days for g-tube feedings, medication administration, vital signs, monitoring, and assessments, and CNA services up to five hours per day seven days a week for assistance with personal care and light housekeeping. a. The agency failed to ensure nursing staff prepared complete and accurate clinical notes for their patients. Review of the Plan of Care dated 10/22/21 to 12/20/21 revealed Employee #1 documented under Caregiver Status, "RN/LPN up to 24 hours/day 7 days/wk." Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatments, "RN/LPN up to 24 hours x day for 60 days," and under Hospitalization/Emergency Room Visit Risk Interventions she documented, "Establish emergency plan and instructions for 24 hour contact." However, it is unclear whether Patient #4 requires 24 hour care or if they require less care. 14. The clinical record for Patient #5 was reviewed on 11/8/21. The Plan of Care for the certification periods dated 9/1/21 to 10/30/21 and 10/31/21 to 12/29/21 revealed a start of care date of 1/4/21; diagnosis included intestinal obstruction, gastrostomy tube, autism, attention-deficit hyperactivity disorder (ADHD), stenosis and atresia (narrowing) of the small intestine, and diarrhea. Plan of Care orders included SN services up to 24 hours per day for 60 days for g-tube feedings, medication administration, vital signs, monitoring, and assessments, and CNA services up to five hours per day seven days a week for assistance with personal care and light housekeeping. a. The agency failed to ensure nursing staff prepared complete and accurate clinical notes for their patients. Review of the Plan of Care dated 10/22/21 to 12/20/21 revealed Employee #1 documented under Caregiver Status, "RN/LPN up to 24 hours/day 7 days/wk." Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatments, "RN/LPN up to 24 hours x day for 60 days," and under Hospitalization/Emergency Room Visit Risk Interventions she documented, "Establish emergency plan and instructions for 24 hour contact." However, it is unclear whether Patient #5 requires 24 hour care or if they require less care. During an interview on 11/2/21 at 3:00 p.m., the Administrator stated the agency had trouble with their frequencies in the past and it was decided the best way to cover the care the patient's needed was to write their frequencies as up to 24 hours of care for each private duty nursing (PDN) patient. She further stated that all of the PDN patients required 24 hour care. 5. The clinical record for Pediatric Patient #14 was reviewed on 11/5/21. The Plan of Care for the certification period dated 10/4/21 to 12/2/21 revealed a start of care date of 10/9/20; diagnoses included pulmonary valve atresia, isomerism of atrial appendages, asplenia and gastrostomy status. Plan of Care orders included RN visits up to 24 hours per day for g-tube feedings and associated care, chest physiotherapy (CPT) twice daily, medication administration, vital signs, monitoring and assessment and CNA visits up to five hours daily for nine weeks for personal care, light housekeeping and continuous line of sight monitoring. a) The agency failed to ensure the RN documented an authentic description of Patient #18's status each visit. Review of overnight (4:00p.m. through 8:00 a.m.) skilled nurse (SN) visits from 10/10/21 through 10/17/21 completed by RN #7 revealed RN #7 had documented the exact same activities at the same times every night. Specifically: "1600-0800 1600-Report received from MOC [mother of child] and discharge paperwork from hospital was reviewed. Pt [patient] stable at transfer of care. Assessment completed all findings. Pt appears to be comfortable. No WPB [wide pulse banking] noted. Pt vitals within ordered limits. Diminished breathe sounds noted in LLL [left lower lung]. TF [tube feeding] running at 80ml/hr. 1/2 LPM [liters per minute] O2 given via NC [nasal cannula]. 1800-Pt diaper changed. Skin and GT [g-tube] stoma is intact and free from s/sx [signs/symptoms] of infection. 2100-Oral and INH [inhaled] Meds given (see MAR). Pt tolerated well. 2130-Pt transferred to bed. Cont [continuous] pulse ox monitoring started. Overnight GT feeding started via pump at 80ml/hr. Diaper changed. Pt remains in bed with all rails up. 2200-Pt remains in bed and appears to be sleeping. Pt is stable on 1/2 LPM O2 with no increased work of breathing noted. 2300-TF running at 80ml/hr without issue. PDN added formula to feeding bag. Pt stable on 1/2 LPM with no increased work of breathing noted. Pt appears to be asleep. 0100-Pulse ox probe changed to opposite foot. TF running without issue. PDN added formula to feeding bag. Pt stable on 1/2 LPM O2 with no increased work of breathing noted. Pt appears to be asleep. 0200-Pt stable on 1/2 LPM O2. Pt appears to be sleeping. 0400-Pulse ox probe changed to opposite foot. Pt stable on 1/2 LPM O2 with no increased work of breathing noted. Pt appears to be asleep. 0600-Pt stable on 1/2 LPM O2. Pt appears to be sleeping. 0800-Care handed off to oncoming nurse. Pt stable at time of handoff." Further review of SN overnight shifts completed by RN #7 for the period 9/16/21 through 11/5/21 revealed similar findings of RN #7 documenting the exact same activities every shift. 6. The clinical record for Pediatric Patient #13 was reviewed on 11/5/21. The Plan of Care for the certification period dated 10/13/21 to 12/11/21 revealed a start of care date of 12/17/20; diagnoses included disorders of lung, chronic respiratory failure, myotonic muscular dystrophy, dysphagia, dependence on ventilator, tracheostomy status and gastrostomy status. Plan of Care orders included RN visits 24 hours daily for ventilator care during naps and overnight, tracheostomy care, CPT three times daily, g-tube feedings and associated care, vital signs, monitoring and assessment and CNA visits up to six and half hours daily for personal care, light housekeeping and continuous line of sight monitoring. a) The agency failed to ensure the RN documented an authentic description of Patient #13's status each visit. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/14/21 through 10/20/21 completed by RN #7 revealed RN #7 had documented the exact same activities at the same times every night. Specifically: "1600-0800 1600-Pt on floor playing with toys. Pt appears stable at time of hand off. Hand off completed with outgoing nurse. 1700-Pt diaper changed and perineal care provided. 1800-Pt transferred to wheelchair. Neb [Nebulizer] treatments (See MAR) and CPT completed. Pt suctioned after treatment. Pt tolerated well. Pt playing in wheelchair. PDN nurse monitoring and reconnecting vent circuit frequently during this time due to Pts movement and Pt pulling circuit apart. 1900-Med given (see MAR) Pt tolerated well. Pt transferred to bed. Pt diaper changed and perineal care given. Skin is CDI [cool, dry, intact]. No redness noted. Ventilation and humidification started in bed with 21pm O2 bled through vent. Cont pulse ox monitoring started. Overnight feeds started via pump at 82ml/hr. Pt laying on back in bed. Bed is in lowest position and all rails are up. Pt remains in bed. 2115-Pt stable. Pt appears to be sleeping. Vitals WNL [within normal limits]. 2330-Pt stable. Vitals stable. Feed running without issue. 0100-Vitals stable. Pt appears to be asleep. Lung sounds clear. 0300-Vitals stable. Feed running and vitals are stable. 0600-Feed ended. Tubing disconnected. 0730-Pt awake in bed. Pt diaper changed. Urine present. Pt suctioned via trach. Med [medium] thick white secretions present. 0800-Handoff completed with oncoming nurse. Pt stable at time of handoff." Further review of SN overnight shifts completed by RN #7 for the period 10/13/21 through 11/5/21 revealed similar findings of RN #7 documenting the exact same activities every shift. 7. The clinical record for Pediatric Patient #16 was reviewed on 11/8/21. The Plan of Care for the certification period dated 10/10/21 to 12/8/21 revealed a start of care date of 12/14/20; diagnoses included bronchopulmonary dysplasia, congenital malformations of respiratory system, chronic respiratory failure, dependence on ventilator, trach status and gastrostomy status. Plan of Care orders included RN to provide around the clock care to include medication administration, g-tube feedings and associated care, CPT three times daily, maintain ventilator during overnight only, trach care, suctioning twice daily, monitoring and assessment. a) The agency failed to ensure the RN documented an authentic description of Patient #16's status each visit. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/10/21 through 10/16/21 completed by RN #7 revealed RN #7 had documented the exact same activities at the same times every night. Specifically: "1600-0800 1600-Pt on floor playing with toys. Pt appears stable at time of hand off. Hand off completed with outgoing nurse. 1700-Pt diaper changed and perineal care provided. Urine present. Pt transferred to wheelchair. Pt suctioned. Neb treatments (See MAR) and CPT completed. Pt tolerated well. Pt suctioned after treatment. 1800-Pt playing in wheelchair. 1900-Med given (See MAR) Pt tolerated well. Pt transferred to bed. Pt diaper changed and perineal care given. Split gauze removed at trach site. Skin is CDI. No redness noted. Cont pulse ox monitoring started. Pt connected to ventilation and humidification. Overnight feed started. Pt laying on back in bed. Bed is in lowest position and all rails are up. Pt remains in bed. 2100-Pt stable. Pt appears to be sleeping. Vitals WNL. 2300-Pt stable. Pt appears to be asleep. Lung sounds clear. 0300-Vitals stable. Pt on right side. Pt appears to remain asleep. Feed running and vitals are stable. 0500-TF ended and disconnected. Pt tolerated well. 0600-Pt appears to be asleep. Pt stable. No s/so of pain or distress. 0800-Handoff completed with oncoming nurse. Pt stable at time of handoff." Further review of SN overnight shifts completed by RN #7 for the period 10/10/21 through 11/5/21 revealed similar findings of RN #7 documenting the exact same activities every shift. 8. The clinical record for Pediatric Patient #17 was reviewed on 11/9/21. The Plan of Care for the certification period dated 10/13/21 to 12/11/21 revealed a start of care date of 12/17/20; diagnoses included anoxic brain damage, hypoxic ischemic encephalopathy, quadriplegia, scoliosis, contracture of unspecified joint and gastrostomy status. Plan of Care orders included RN visits 24 hours per day for g-tube feedings, medication administration, vital signs, monitoring and assessment and CNA visits up to seven hours daily for personal care, light housekeeping and continuous line of sight monitoring. a) The agency failed to ensure the RN documented an authentic description of Patient #18's status each visit. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/13/21 through 10/18/21 completed by RN #7 revealed RN #7 had documented the exact same activities at the same times every night. Specifically: "1600-0800 1600-Pt laying in bed on left side. Pt appears stable at handoff. Handoff completed with outgoing nurse. 1700-Assessment completed. All finding WNL per orders and Pt's baseline. Started feed via pump at 500ml/hr. 1730-feed complete. Pt tolerated well. 1800-Pt repositioned. 1900-Pt repositioned. Brief changed. Urine present. 2000-Meds given (see MAR). Pt tolerated well. 2200-Pt transferred to therapy bed. Pt brief changed. Med BM [bowel movement] present. Perineal care provided. 2230-Pt transferred to bed. Overnight feed started. Continuous pulse ox monitoring started. All rails on bed up. Pt remains in bed. 0000-Pt repositioned. Pt appears to be asleep. Pt is stable. 0200-Pt repositioned. Pulse ox probe place on different finger. Pt tolerated well 0400-Pt repositioned Pt appears to be asleep. Pt is stable. Pt tolerated well. 0600-Pt repositioned Pulse ox probe placed on different finger. Pt tolerated well. Overnight feed complete and disconnected. 0700-Pt awake in bed. Meds given (see MAR). Pt tolerated well. 0800-Hand off completed with oncoming nurse. Pt is stable at time of handoff." Further review of SN overnight shifts completed by RN #7 for the period 10/13/21 through 11/5/21 revealed similar findings of RN #7 documenting the exact same activities every shift. 9. The clinical record for Pediatric Patient #18 was reviewed on 11/3/21. The Plan of Care for the certification period dated 9/16/21 to 11/12/21 revealed a start of care date of 9/16/21; diagnoses included failure to thrive, non-traumatic intracerebral hemorrhage, convulsions and gastrostomy status. Plan of Care orders included RN visits up to 24 hours a day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment. a) The agency failed to ensure the RN documented an authentic description of Patient #18's status each visit. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/10/21 through 10/16/21 completed by RN #7 revealed RN #7 had documented the exact same activities at the same times every night. Specifically: "1600-0800 1600-Pt in bed on back watching iPad at time of handoff. Pt stable. 1800-Meds given (see MAR) Pt tolerated well. Pt cont feed started at 60ml/hr. Assessment completed. All findings WNL. Perineal care provided and diaper changed. Pt in bed on back all rails up. 2000-Pt stable and repositioned. TF continues to run w/o issue. Pt appears to be asleep. 2200-Pt repositioned. Pt appears to remain asleep. TF running. 0000-Pt stable and appears to be sleeping. TF running w/o issue. Pt repositioned 0200-TF running. Pt repositioned. 0400-TF running. Pt repositioned. 0600-TF stopped. Pt awake in bed. Pt stable and smiling. 0800-Pt stable. No s/sx of pain present. Care handed off to oncoming nurse." Further review of SN overnight shifts completed by RN #7 for the period 9/16/21 through 11/5/21 revealed similar findings of RN #7 documenting the exact same activities every shift. During an interview on 11/4/21 at 9:00 a.m., RN #7 stated her documentation of each shift is the same as the patient's residing in the home have a routine and it rarely changed. RN #7 further stated that her documentation could be better and would work on it. Findings Include: AGENCY POLICY According to the agency policy titled, "Job Description Registered Nurse," dated 2007 (in pertinent parts): "13. Maintains adequate and timely records and reports of evaluation data, interventions, and patient's response to interventions." 1. The clinical record for Patient #7 was reviewed on 11/8/21. The Plan of Care for the certification period dated 10/16/21 to 12/14/21 revealed a start of care date of 10/16/21; diagnoses included hypoxic ischemic encephalopathy, anoxic brain damage, cortical blindness, gastrostomy status, congenital hypertonia, and lack of expected normal physiological development in childhood Plan of Care orders included registered nurse (RN) visits up to 24 hours daily for gastrostomy tube (g-tube) feedings, medication administration, vitals signs, monitoring and assessment and continuous line of sight supervision and nursing interventions during a seizure and certified nursing assistant (CNA) visits up to 6 hours for assistance with personal care, light housekeeping and continuous line of sight monitoring. a. The agency failed to ensure the RN documented an accurate description of Patient #7's seizures and care provided during the seizure. Review of Ped visit p.m. (4:00 p.m. to 8:00 a.m.) notes dated 10/16/21 through 11/2/21 revealed RN #5 documented Patient #7 had "Seizures intermittent." RN #5 failed to document the length of each seizure, how many seizures total he had during the shift, the interventions RN #5 used to protect Patient #7 during the seizures, if she had to administer Patient #7's rescue seizure medication (Midazolam to be given for seizures lasting greater than 5 minutes) , and if she provide Patient #7 with line of sight supervision during the seizure as ordered on his POC. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that Patient #7 had one or more seizures a day and she had never had to administer Patient #7 rescue seizure medication as his seizures did not last that long. 2.The clinical record for Patient #8 was reviewed on 11/8/21. The Plan of Care (POC) for the certification period 9/19/21 to 11/17/21 revealed a start of care date of 5/27/20; diagnoses included dependence on renal dialysis, dysphagia, anemia in chronic kidney disease, unspecified lack of expected normal physiological development in childhood and congenital hypothyroidism. Plan of Care orders included RN/licensed practical nurse (LPN) up to 24 hours a day for peritoneal dialysis, gastrostomy tube feedings, medication administration, vitals, monitoring and assessment; and CNA up to six times a day for assistance with personal care and light housekeeping. a. The agency failed to ensure the RN documented an accurate description of Patient #8's status. Review of a Ped Visit note completed on 10/28/21 for the 8:00 a.m. to 4:00 p.m. shift by RN #4 revealed at 4:00 p.m., RN #4 documented Patient #8 had no signs or symptoms of distress or discomfort at that time, but in the next sentence, she documented Patient #8 was observed to grab her GJ (gastrostomy-jejunostomy) tube site several times and complained of pain when standing. The RN failed to document an accurate assessment of Patient #8's status as it is unclear whether Patient #8 was in pain or without pain. Review of a Ped Visit note completed on 10/28/21 for the 4:00 p.m. to 8:00 a.m. shift by RN #5, revealed RN #5 documented Patient #8 had abdominal pain with a pain level of five. RN #5 failed to provide the scale for this pain rating in her note and did not indicate what pain tool she used to determine Patient #8's pain level. RN #5 documented Patient #8 was holding her left side, was "very pale", heart rate of 150 beats per minute (bpm), and her abdomen appeared distended, but was soft and Patient #8 was without signs or symptoms of pain with palpation. RN #5 documented that Patient #8's PD catheter site was "red intact" and her GJ tube dressing was clean, dry and intact. RN #5 documented that Patient #8 was afebrile and free of signs or symptoms of infection. The RN failed to document an accurate assessment of Patient #8's status, as it was unclear if the patient had signs or symptoms of an infection. b. The agency failed to ensure the RN documented an accurate and complete clinical visit note. Review of Ped visit p.m. (4:00 p.m. to 8:00 p.m.) notes dated 10/15/21 to 10/24/21, revealed RN #5 documented the same narrative note for ten nights in a row as follows, " 1600-0800 Patient tolerating her new formula well. Irregular heart sounds noted but good pulses and perfusion. VSSA [vital signs stable afebrile] PD[peritoneal dialysis] catheter site clean, dry, and intact. GT [gastrostomy tube] dressing clean, dry and intact Abdomen appears distended but is soft and child is without s/sx [sign/symptom] of pain with palpation. Eyes appear deconjugate at times. Patient running continuous enteral feed of formula mixture through j [jejunostomy] tube at 38ml/hr. Diaper dry at this time. Patient afebrile and free of s/sx of infection. GT cares and bath done prior to this RN's shift per report. Peritoneal dialysis running as ordered 2100 - 0500 Patient awoke several times coughing PD tubing and feed tubing kinked several times and patient had to be repositioned. Enteral feed running continuously via JT [jejunostomy tube] per orders. Nasal suction x 1 overnight for moderate thick cloudy secretions. Patient awake coughing several times overnight. 0600- Patient awake and alert. Diaper changed. Moderate UOP [urinary output] and medium soft BM [bowel movement] 0700- Patient awake and alert playing with toys in crib. 0800 - Patient sitting up in crib smiling and playing with toys Free of s/sx of distress or discomfort Dialysis finished this am and disconnected." RN #5's documentation failed to provide an accurate description of the cares provided during the shift. Further, RN #5 failed to identify within the body of the note, if Patient #8 has a g-tube, a j-tube or a gj-tube. Review of RN #5 notes for Patient #8 dated 9/19/21 to 11/6/21 revealed similar findings of the notes having very little variation in content. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that she tries to give a description of what happened during the shift at the beginning of her note. RN #5 stated her documentation is not perfect. 3. The clinical record for Patient #10 was reviewed on 11/15/21. The POC for the certification periods 9/5/21 through 11/3/21 and 11/4/21 through 1/2/22 revealed a start of care date of 1/8/21; diagnoses included Seizures, gastrostomy status, esophageal reflux, atrial septal defect, patent ductus arteriosus, protein-calorie malnutrition, chronic obstructive pulmonary disease, hypoxemia, developmental delays, anisometropia and eczema. POC orders included RN up to 24 times a day for g-tube feedings, medication administration, vital signs, monitoring, assessment, and continuous line of sight supervision and nursing interventions during seizure activity and CNA up to six times a day for assistance with personal care, light housekeeping and continuous line of sight monitoring. a. The agency failed to ensure staff provided complete and accurate clinical notes. Review of Peds visit p.m. (4:00 p.m. to 8:00 a.m.) notes for Patient #10 dated 9/15/21 to 10/15/21, completed by RN #5, revealed RN #5 documented 41 nights in a row the same narrative in her note as follows: "16:00-0800 Lung sounds clear and equal GT [gastrostomy tube] cares and diaper changed prior to this RN's shift per report. Continuous overnight GT feed running per orders. 2100-0600- Patient sleeping in crib free of s/sx [signs/symptoms] of distress or discomfort. Continuous GT feed running per orders. Patient repositioned self several times overnight. Patient awake several times overnight and had to be consoled by RN to fall back asleep. 0600 Overnight GT feed complete Flushed with water per orders. Patient awake and alert, smiling and playing with toys in crib Diaper changed for moderate UOP [urinary output] and medium soft BM [bowel movement]. GT site clean, dry, intact and open to air. 0700 Patient supervised playing with siblings. 0800 Patient awake and alert playing with toys in crib. Diaper changed for moderate UOP and medium soft BM. No s/sx of distress or discomfort noted at this time." RN #5's documentation failed to provide an accurate picture of cares provided and Patient #10's medical status during the shift. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that she tries to give a description of what happened during the shift at the beginning of her note. RN #5 stated her documentation is not perfect. During an interview on 11/17/21 at 10:42 a.m., the DON stated that she had taken a step back from tasks in the agency this past year due to various personal reasons and the quality assurance checks that she normally would do, were not done when she had decreased her hours. The DON stated the agency needed to improve the oversight of documentation and the DON had already begun in-servicing the staff on the importance of writing a complete and accurate note. The DON stated the agency's plan was to hire a quality assurance nurse to help get the agency back on track especially with documentation, POC and assessments/reassessments.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on interview and record review the agency failed to ensure nursing professional services communicated with the physician of changes in condition for 1 of 18 pediatric patients (Patient #8) and the agency failed to ensure nursing professional services communicated with the physician to obtain orders for changes to the Plan of Care for 7 of 18 pediatric patients reviewed receiving private duty nursing (PDN) (Patients #1, #6, #8, #9, #10, #14, and #18). 4. The clinical record for Patient #6 was reviewed on 11/16/21. The POC for the certification periods dated 8/31/21 to 10/29/21 and 10/30/21 to 12/28/21 revealed a start of care date of 3/4/21; diagnosis included necrotizing enterocolitis, postgastric surgery syndromes, dysphagia (swallowing difficulties), sepsis, and gastrostomy tube placement. POC orders included skilled nursing (SN) services sixteen times a day for 1 hour for 60 days total and SN services eight times per day for 1 hour for 60 days for total parenteral nutrition, medication administration, vitals, monitoring, and assessment, and certified nurse aide (CNA) services up to seven times per day for one hour for 60 days for assistance with personal care and light housekeeping. a. The agency failed to ensure communication with the physician to obtain orders for changes to the Plan of Care. Specifically, the agency failed to ensure the SN obtain orders for increasing Patient #6's tube feedings. Review of the Plan of Care dated 8/31/21 to 10/29/21 revealed orders for "G-tube feedings of Elacare 24 kcals 840 mls +30 mls of green bean puree +35 mls per hour over 24 hours. Increase formula every 2 days as tolerated with goal of 44 mls/hour." Review of the Peds visit AM note dated 9/7/21, RN #4 documented Patient #6's G-tube feedings were running at 43 milliliters per hour (ml/hr). Review of the Peds visit AM note dated 9/14/21, RN #4 documented Patient #6's G-tube feedings were running at 44 ml/hr. However, between 9/7/21 and 9/14/21 there was no evidence of documentation of the current G-tube rate to show when the feeding rate was increased and what rate it was running at before the nurse increased the rate. Review of the Peds visit PM note dated 9/6/21, RN #5 documented, "1600-0800 (4:00 p.m. to 8:00 a.m.) Slowly increasing feeds." There is no evidence of documentation of what the G-tube feedings were running at or what the rate was being increased to. RN #5 continued to document she was slowly increasing the G-tube feeding rate from 9/14/21 to 10/2/21, 18 days after Patient #6 reached their goal of 44 mls/hr. Further review showed RN #5 did not document what Patient #6's G-tube feeding rate was or what it was being increased to. Review of the Peds visit PM note dated 10/8/21 revealed RN #5 documented Patient #6 was receiving G-tube feedings at the ordered rate of 46 mls/hr, however, there was no evidence of a physician order to increase the rate to 46 mls/hr until the new Plan of Care was established on 10/30/21. Review of the Plan of Care dated 10/30/21 to 12/28/21 revealed orders for, "G-tube feedings of Elacare 24 kcals 1104 mls +10mls of green bean purees @ 46 mls per hour over 24 hours." Review of the Peds visit AM note dated 11/1/21 revealed RN #4 documented, "GT (G-tube) feed running continuously at 47 mL/hr." However, there was no evidence of a physician order for a G-tube feeding rate of 47 mls/hr on the Plan of Care. RN #4 documented Patient #6 was receiving a G-tube feeding rate of 47 mls/hr from 11/1/21 to 11/4/21. b. The agency failed to ensure communication with the physician to obtain orders for changes to the POC. Specifically, the agency failed to ensure the SN obtained orders for saline, heparin, and Vancomycin flushes to be provided with Patient #6's central venous catheter (CVC). Review of the POC dated 8/31/21 to 10/29/21 revealed Patient #6 had a Broviac CVC for the administration of total parenteral (intravenously infused) nutrition (TPN). Further review of the POC revealed the following CVC care orders: "Dressing Change weekly 1.Wash hands thoroughly with soap and water 2. Open packages 3. Put on gloves 4. Remove the old dressing 5. Check site for infection (i.e. redness, swelling or drainage) 6. Remove dirty gloves 7. Wash hands again or sanitize . Put on new, clean gloves. 8. Clean the exit site with chlorhexidine swabstick using a repeated back and forth motion for 30 seconds. Make sure to clean all parts of the catheter that will be under the dressing. 9. Allow to air dry for 15-30 seconds. Do not blow or fan the skin. 10. If desired, apply skin protectant to the outer edge of skin. Do not apply directly on the catheter. 11. Apply the clear dressing and bio patch" Review of the medication on the POC dated 8/31/21 to 10/29/21 revealed an order for, "ALTEPLASE (1 mg/ml) 0.33 mg via central line to clear withdrawal occlusion in the home One time and as needed in the future for withdrawal occlusion intravenous (IV)." Review of the Peds visit PM note dated 9/2/21 revealed RN #5 documented, "CVC flushed with saline and heparin/vanco [antibiotic] per orders," however, there were no orders on the Plan of Care for a saline flush, heparin flush or vancomycin instillation for the CVC. Further review of the Peds visit PM notes and the Peds visit AM notes dated 9/2/21 to 11/3/21 revealed staff RN's continued to chart intermittently they were flushing the CVC with saline, heparin, and vancomycin per orders, however, no evidence of these flushes was found on the POC or in physician's orders. During an interview on 11/16/21, RN #5 stated she received orders in the form of an after hours summary provided by the physician during physician appointments and these were conveyed to the rest of the agency staff involved in Patient #6's care primarily by email and by a social networking application (Whatsapp). She further stated that this was how all of the PDN SNs got their orders and forwarded them on to other pertinent staff members. During an interview on 11/17/21, the agency administrator stated in between certification periods, physician orders were not generated in the agency electronic medical record (EMR). She stated the SNs received a care summary after physician appointments but they were not placed into the EMR as new physician orders that were sent to the physician for approval and signature. During further interviews with the agency administrator, the administrator stated agency staff were supposed to follow the POC as ordered by the physician, and the agency thought they had been doing that by following the after care summary given to the staff by the physician. She further stated they did not realize the after care summaries were not physician orders, only a summary of what the physician appointment entailed, and she stated going forward, the SNs would be submitting the after care summaries to the administrator and director of nursing to process into physician's orders in the EMR. 5. The clinical record for Patient #18 was reviewed on 11/3/21. The POC for the certification period dated 9/16 to 11/12/21 revealed a start of care date of 9/16/21; diagnoses included failure to thrive, non-traumatic intracerebral hemorrhage, convulsions and gastrostomy status. POC orders included RN visits up to 24 hours a day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment. Review of medications listed on the POC showed Pediatric Patient #18 was to receive Baclofen 5 milligrams (mg)/milliliter (ml) oral suspension, given 1.5 mls (7.5 mg) three times daily via j-tube. Review of Patient #18's medication profile showed he was to receive a Baclofen 10 mg oral tablet to be crushed and given one tablet via j-tube three times daily. Further review showed the 7.5 mg Baclofen had been discontinued on 11/14/21. There was no evidence an order had been obtained from the physician to make this change to Patient #18's Baclofen medication. Clinical record review revealed no evidence the agency had contacted the physician to obtain a physician's order to increase Patient #18's Baclofen from 7.5 mg three times daily to 10 mg three times daily. 6. The clinical record for Patient #14 was reviewed on 11/5/21. The POC for the certification period dated 10/4 to 12/2/21 revealed a start of care date of 10/9/20; diagnoses included pulmonary valve atresia, isomerism of atrial appendages, asplenia and gastrostomy status. POC orders included RN visits up to 24 hours per day for g-tube feedings and associated care, chest physiotherapy (CPT) twice daily, medication administration, vital signs, monitoring and assessment and CNA visits up to five hours daily for nine weeks for personal care, light housekeeping and continuous line of sight monitoring. Review of medications listed on the POC showed Furosemide 10 mg/ml oral liquid, give 1.5 mls via g-tube three times daily. Review of Patient #14's medication profile showed the Furosemide 1.5 mls via g-tube three times daily had been discontinued on 11/14/21. There was no evidence an order had been obtained from the physician to make this change. Clinical record review revealed no evidence the agency had contacted the physician to obtain a physician's order to discontinue Patient #14's Furosemide. During an interview on 11/9/21 at 8:53 a.m., the director of nursing (DON) stated medication changes were tracked on the patient's medication profile and medication administration record (MAR). The DON stated nursing staff would administer medications according to the MAR. The DON further stated any changes in medications were provided by the patient's mothers according to physician appointments aftercare instructions and no physician orders had been obtained for the medication changes. 7. The clinical record for Patient #1 was reviewed on 11/1/21. The POC for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnosis included spastic quadriplegic cerebral palsy, unspecified convulsions, and obstructive sleep apnea. POC orders included SN services up to sixteen hours per day and SN services up to eight hours per day for a total of up to 24 hours per day for gastrostomy tube feedings, medication administration, monitoring, vital signs (VS), and assessments, and CNA services up to five hours per day for assistance with personal cares and light housekeeping. a. The agency failed to ensure communication with the physician with changes in the patient's condition. Specifically, the agency failed to communicate with the physician when Patient #1 had vital signs outside the physician ordered parameters. Review of the POC dated 10/22/21 to 12/20/21 revealed orders for, "VITAL SIGNS PARAMETERS Notify Physician if: Pulse is greater than 135 or less than 50, Respirations are greater than 40 or less than 10, SPO2 [oxygen saturation]: is less than 90% at rest/with exertion, Temperature is greater than 101.0 or less than 95.0." Review of the Peds visits AM note dated 10/30/21 revealed RN #17 documented Patient #1 had a heart rate of 140. Further review of the visit note revealed no evidence the RN notified the physician of Patient #1's heart rate being outside of the ordered parameters. Review of the clinical record dated 10/22/21 to 11/1/21 revealed no evidence RN #17 documented any communication with the patient's physician about the patient's heart rate. During an interview on 11/2/21 at 11:30 a.m., RN #5 stated when the SN on the day shift finds any issues with the patient they usually told her and she contacted the physician to coordinate care. However, there was no evidence in the clinical record for Patient #1 of RN #5 contacting the physician to report the patient's heart rate outside of physician parameters. 5. The clinical record for Patient #18 was reviewed on 11/3/21. The POC for the certification period dated 9/16 to 11/12/21 revealed a start of care date of 9/16/21; diagnoses included failure to thrive, non-traumatic intracerebral hemorrhage, convulsions and gastrostomy status. POC orders included RN visits up to 24 hours a day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment. Review of medications listed on the POC showed Pediatric Patient #18 was to receive Baclofen 5 milligrams (mg)/milliliter (ml) oral suspension, given 1.5 mls (7.5 mg) three times daily via j-tube. Review of Patient #18's medication profile showed he was to receive a Baclofen 10 mg oral tablet to be crushed and given one tablet via j-tube three times daily. Further review showed the 7.5 mg Baclofen had been discontinued on 11/14/21. There was no evidence an order had been obtained from the physician to make this change to Patient #18's Baclofen medication. Clinical record review revealed no evidence the agency had contacted the physician to obtain a physician's order to increase Patient #18's Baclofen from 7.5 mg three times daily to 10 mg three times daily. 6. The clinical record for Patient #14 was reviewed on 11/5/21. The POC for the certification period dated 10/4 to 12/2/21 revealed a start of care date of 10/9/20; diagnoses included pulmonary valve atresia, isomerism of atrial appendages, asplenia and gastrostomy status. POC orders included RN visits up to 24 hours per day for g-tube feedings and associated care, chest physiotherapy (CPT) twice daily, medication administration, vital signs, monitoring and assessment and CNA visits up to five hours daily for nine weeks for personal care, light housekeeping and continuous line of sight monitoring. Review of medications listed on the POC showed Furosemide 10 mg/ml oral liquid, give 1.5 mls via g-tube three times daily. Review of Patient #14's medication profile showed the Furosemide 1.5 mls via g-tube three times daily had been discontinued on 11/14/21. There was no evidence an order had been obtained from the physician to make this change. Clinical record review revealed no evidence the agency had contacted the physician to obtain a physician's order to discontinue Patient #14's Furosemide. During an interview on 11/9/21 at 8:53 a.m., the director of nursing (DON) stated medication changes were tracked on the patient's medication profile and medication administration record (MAR). The DON stated nursing staff would administer medications according to the MAR. The DON further stated any changes in medications were provided by the patient's mothers according to physician appointments aftercare instructions and no physician orders had been obtained for the medication changes. Finding include: AGENCY POLICY According to the agency policy titled, "Physician Role in Home Care of Patients Plan of Care (POC) and Interim Orders," dated 2007, (in pertinent parts): "1. Agency clinical professional staff will maintain contact with the physician or designee regarding the patient's changing condition and for clinical updates and physician requests for information." According to the agency policy titled, "Job Description Registered Nurse," dated 2007 (in pertinent parts): "6. Serves as coordinator of patient's care including referral to other services as appropriate and adherence to the plan of care. 7. Informs the physician and other personnel of changes in the patient's needs or service requests." 1. The clinical record for Patient #8 was reviewed on 11/8/21. The Plan of Care (POC) for the certification period 9/19/21 to 11/17/21 revealed a start of care date of 5/27/20; diagnoses included dependence on renal dialysis, dysphagia, anemia in chronic kidney disease, unspecified lack of expected normal physiological development in childhood and congenital hypothyroidism. POC orders included registered nurse (RN)/licensed practical nurse (LPN) up to 24 hours a day for peritoneal dialysis, gastrostomy tube feedings, medication administration, vitals, monitoring and assessment; and certified nursing aide (CNA) up to six times a day for assistance with personal care and light housekeeping. Review of the POC for the certification period 9/19/21 to 11/17/21 revealed Patient #8 was to receive daily PD with a delivery system of continuous cycling peritoneal dialysis for eleven hours daily. Patient #8 was to receive a dressing change at her PD catheter site every one to two days or if it became wet, soiled or came off. The orders for the dressing change included "use a sterile technique and while masked: remove soiled dressing, cleanse the site with Exsept (a wound care cleaner), leave crusts or scabs in place to heal, apply gentamicin (an antibiotic ointment) as needed, place a new secure dressing to the site". a. The agency failed to ensure communication with the physician with changes in the patient's condition. Specifically, the agency failed to communicate with physician who coordinated Patient #8's dialysis when she developed a PD line infection. Review of a document titled "G-tube and PD Catheter Care", dated 6/2/20 showed exit site infections at the PD catheter were possible with the symptoms including redness, swelling, pain at the exit site and/or drainage/pus from the exit site. The document then provided instructions if these symptoms were noted to call the PD nurse immediately and if it was a night, weekend, or holiday to call the dialysis nurse on call, obtain a culture, and start antibiotics and antifungal medications as directed by the nurse. Review of the "After Visit Summary" dated 10/4/21 and 11/1/21 showed RN #5 (the foster mother of the patient), documented "call the PD Nurse Line or on-call nurse with any sign of peritonitis (inflammation of the membrane lining the abdominal wall and covering the abdominal organs, usually infectious and often life-threatening) with the following examples of symptoms: fever, chills, abdominal pain, irritability, abdominal swelling, full or distended abdomen, cloudy PD drainage, lower back pain, nauseous and vomiting, fibrin (white strands) in the PD drainage, low drain alarms, or constipation." Review of a Ped visit note completed on 10/26/21 by RN #4 for 8:00 a.m. to 4:00 p.m. shift revealed RN #4 documented Patient #8's PD catheter site was clean, dry and intact, and PD catheter site care was provided. RN # 4 documented cleaning the gastrostomy-jejunostomy (GJ) tube site, changing the dressing and the technique she used which followed the plan of care orders. At 4:00 p.m. RN #4 documented patient had no signs or symptoms of distress or discomfort at that time and that Patient #8 was observed to grab her GJ tube site several times and complained of pain. RN #4 noted she assessed the GJ tube site several times and no changes or concerns were noted. RN #4 stated the mother of Patient #8 (RN #5) was notified of Patient #8's complaints of pain. However, further review of Patient #8's chart failed to show evidence that RN #4 communicated with Patient #8's medical doctor (MD) or the PD clinic to inform her of Patient #8's symptom of abdominal pain, a potential sign of peritonitis. Review of a Ped visit note completed on 10/26/21 for 4:00 p.m. to 8:00 a.m. shift by RN #5 revealed RN #5 documented Patient #8 was crying on and off and her PD catheter site was red but no discharge was noted. GT dressing clean, dry and intact. RN #5 documented Patient #8's abdomen appeared to be distended but was soft and Patient #8 was without signs or symptoms of pain with palpation. RN #5 documented that PD ran from 9:00 p.m. to 5:00 a.m. RN #5 also then documented at 8:00 a.m. that Patient #8 was free of signs or symptoms of distress or discomfort. RN #5 documented on the medical administration record (MAR) she applied gentamicin 0.1% topical cream to the PD site at 8:00 a.m. on 10/27/21. Further review of the patient's record revealed no evidence RN #5 communicated with Patient #8's MD or the PD clinic to inform her of Patient #8's symptom of a red PD site, a sign of a potential PD site infection, and her symptoms of irritability and distended abdomen, signs of a potential peritonitis. Review of a Ped visit note completed on 10/27/21 for the 4:00 p.m. to 8:00 a.m. shift by RN #5 revealed RN #5 documented Patient #8 was crying on and off and her PD catheter site was red but no discharge was noted. RN #5 documented Patient #8's abdomen appeared to be distended but was soft and Patient #8 was without signs or symptoms of pain with palpation. RN #5 also documented at 8:00 a.m. Patient #8 was free of signs of symptoms of distress or discomfort. Further review failed to show evidence RN #5 had communicated with Patient #8's PD clinic doctor to inform her of Patient #8's symptom of a red PD site, a sign of a potential PD site infection, and her symptoms of irritability and distended abdomen, signs of a potential peritonitis. A Ped Visit note completed on 10/28/21 for the 8:00 a.m. to 4:00 p.m. shift by RN #4 revealed documentation Patient #8's PD catheter site was clean, dry and intact. RN #4 documented under interventions that PD catheter site care was provided. At 4:00 p.m. RN #4 documented Patient #8 was observed to grab her GJ tube site several times and complained of pain when standing. RN #4 documented RN #5 was notified of Patient #8's complaints of pain. However, further review of Patient #8's chart failed to show evidence that RN #4 communicated with Patient #8's PD clinic doctor to inform her of Patient #8's symptom of abdominal pain, a potential sign of peritonitis. Review of a Ped Visit note completed on 10/28/21 for the 4:00 p.m. to 8:00 a.m. shift by RN #5 revealed RN #5 documented Patient #8 had abdominal pain with RN #5 documenting Patient #8's pain level as a five. RN #5 documented Patient #8 was holding her left side, was "very pale", heart rate of 150 beats per minute (bpm), and her abdomen appeared distended but was soft and Patient #8 was without signs or symptoms of pain with palpation. RN #5 documented that Patient #8's PD catheter site was "red intact" and her GJ tube dressing was clean, dry and intact. Further review of Patient #8 record failed to show evidence RN #5 had communicated with Patient #8's PD clinic physician to inform her of Patient #8's symptom of a red PD site, a sign of a potential PD site infection, and her symptoms of abdominal pain and distended abdomen, signs of a potential peritonitis. A Ped visit note completed on 10/29/21 for the 8:00 a.m. to 4:00 p.m. shift by RN #4 revealed RN #4 documented at 8:00 a.m. that she received report from RN #5, completed her initial assessment of Patient #8. RN #4 documented that Patient #8 continued to grab at GJ tube site and complained of pain, HR was elevated to 150 bpm, and RN #4 administered as needed (PRN) Tylenol at 9:00 a.m. per the MAR. RN #4 then documented that the foster mother of the child (RN #5) was aware and MD notified, this was three days after Patient #8 began to show signs and symptoms of a potential PD site infection and/or peritonitis. Review of a Ped visit note completed on 10/29/21 by RN #5 for 4:00 p.m. to 8:00 a.m.shift revealed RN #5 documented that pictures of Patient #8 PD site and abdomen were sent to the PD clinic. RN #5 documented she informed the PD clinic of Patient #8's pain via an internet based application used by the PD clinic. In the email communication to the PD clinic, RN #5 described Patient #8's bowel movement frequency had increased and Patient #8 was gassy so RN #5 decreased the dosage of her Miralax (a laxative medicine used to treat occasional constipation) and planned to stop using the Miralax as of 10/30/21. RN #5 described Patient #8 as "dramatic" at times. The PD clinic nurse responded to RN #5 with an email on 10/29/21 at 12:09 p.m. instructing RN #5 to loop the PD catheter on top of the dressing, if RN #5 was not already using this technique, as the PD clinic RN felt Patient #8's PD catheter exit site looked enlarged and any little movement could cause enlargement of this site. Additionally the PD clinic RN stated Patient #8's pain could be coming from the slightly enlarged site or with the increased stool perhaps from her colon. The PD clinic nurse was in agreement to decrease Miralax slowly as perhaps Patient #8 had developed a GI virus and the PD clinic RN reminded RN #5 to make sure Patient #8 had at least one soft stool a day. Additionally the PD clinic RN reminded RN #5 of the signs of peritonitis to watch for: cloudy PD drainage, abdominal pain, fever, chills, lower back pain, nausea or vomiting, fibrin, low drain alarms, full/distended abdomen, and constipation. The PD clinic MD responded to RN #5 in an email on 10/29/21 at 2:21 p.m. agreeing with the PD clinic RN's advice and reiterated to RN #5 if Patient #8 had any of the warning signs of peritonitis or if Patient #8 did not improve to inform the PD clinic. Review of a Ped visit note dated 10/30/21 completed by RN #5 for the 4:00 p.m. to 8:00 a.m. shift revealed RN #5 documented that Patient #8 had abdominal pain and RN #5 documented the pain at level five. RN #5 failed to provide the scale for this pain rating in her note and did not indicate what pain tool she used to determine Patient #8's pain level. RN #5 documented Patient #8 complained of pain all day. RN #5 documented in the body of her note that she administered Tylenol for pain. RN #5 documented that Patient #8's abdomen was distended but soft and without signs or symptoms of pain with palpation. RN #5 documented that Patient #8's PD catheter site was red, slightly moist and intact. However, further review of Patient #8's record failed to show evidence RN #5 communicated with Patient #8's PD clinic physician to inform her of Patient #8's symptoms of a red and moist PD site, and her symptoms of abdominal pain and distended abdomen, signs of a potential peritonitis. A Ped visit note dated 10/31/21 completed by RN #5 for the 4:00 p.m. to 8:00 a.m. shift revealed RN #5 documented that Patient #8 heart rate was 150 bpm, that Patient #8 had abdominal pain and RN #5 documented the pain at level five. RN #5 documented Patient #8 complained of pain all day. RN #5 documented in the body of her note that she administered Tylenol for pain. RN #5 documented that Patient #8's abdomen was distended but soft and without signs or symptoms of pain with palpation. RN #5 documented that Patient #8's PD catheter site was red, slightly moist and intact. Further review of Pediatric Patient #8's record failed to show evidence RN #5 communicated with Pediatric Patient #8's MD or the PD clinic to inform them of Pediatric Patient #8's symptom of a red and moist PD site, and her symptoms of abdominal pain and distended abdomen, signs of a potential peritonitis. Review of a Ped visit note dated 11/1/21 completed by RN #5 for the 4:00 p.m. to 8:00 a.m. shift showed documentation Patient #8 was seen by the PD clinic for a regularly scheduled appointment and due to Patient #8 not feeling well. RN #5 documented that Patient #8's PD site dressing was changed in the PD clinic and pus was noted around the PD catheter. Cultures were taken by the PD clinic RN and Patient #8 was started on an antibiotic and nystatin (an antifungal). RN #5 documented in the infection control section of her note that Patient #8 had a new infection. RN #5 documented that Patient #8 had many changes to her POC but further record review failed to show orders were obtained from a physician to reflect the changes to Patient #8's POC. Specifically, no orders were found for the Keflex antibiotic that was started; for the nystatin; for a change in Patient #8s feeding flow rate, an increase in the dosage of Epogen (medicine used to treat lower than normal red blood cells), to hold Patient #8's sodium bicarbonate and to stop Patient #8's potassium chloride. During an interview on 11/9/21 at 11:32 a.m., RN #3 stated that she could not recall if Patient #8 had any pain during her shift on 10/31/21 but she did recall RN #5 reported to her that Patient #8 complained of pain. RN #3 stated after Patient #8 was seen by the PD clinic doctor, Patient #8 was placed on a 21 day course of antibiotics and Patient #8 had further changes in her orders which included increasing her frequency of baths from once every other day to daily and RN #5 was instructed to change the PD site dressing daily. There was no communication note or orders noted in Patient #8's record to reflect the changes in bathing frequency and dressing changes made by Patient #8's PD clinic physician. During an interview on 11/9/21 at 12:27 p.m. RN #4 confirmed that on 10/26/21, she observed Patient #8 grabbing at her GJ tube site and this led RN #4 to assess the GJ tube site as Patient #8 had a granuloma (small area of inflammation) at the GJ tube site. RN #4 stated she felt the pain could be coming from that site. RN #4 stated that she informed RN #5 of Patient #8's complaints of pain and RN #4 stated RN #5 called the doctor but she could not recall the timeline on when the phone call was made. RN #4 stated she would have called the doctor if RN #5 had not called the doctor. RN #4 stated due to RN #5 also being Patient #8's foster mother, RN #5 asked the other RNs caring for Patient #8 to inform RN #5 of any changes of conditions with Patient #8. Further, RN #4 stated RN #5 normally took on the responsibility to inform the doctor about changes of condition. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated prior to the 11/1/21 PD clinic MD visit dressing changes were being done by RN #5 once every other day. RN #5 stated she did not recall when she first notified the MD of Patient #8's red PD site or abdominal pain but RN #5 felt it was before 10/31/21. RN #5 did not recall documenting that Patient #8 had a pain level of 5 so she could not provide what scale she used to document that pain level. RN #5 stated when Patient #8 was assessed in the PD clinic Patient #8's PD site had a little bit of drainage that looked different. The PD clinic started Patient #8 on antibiotics prophylactically and asked RN #5 to change the PD site daily. b. The agency failed to ensure communication with the physician to obtain orders for changes to the Plan of Care. Specifically, the agency failed to ensure orders were obtained for changes made to Patient #8's medications. Review of Patient #8's POC for the certification period 9/19/21 through 11/17/21 revealed Patient #8 was to receive multiple medications which included: Captopril 1/mg/ml (milligram/milliliter) 0.3 (no units were provided on the POC) through g-tube or by mouth two times daily; Miralax oral powder for reconstitution 17gm/scoop (gram/scoop), 2.833 gm by mouth every other day as need; Retacrit 4000 units/ml preservative free injectable solution administer 920 units (0.23mls) subcutaneously weekly on Mondays; Calcitriol 1 mcg/ml (microgram/ml) oral liquid 0.5 mcg(0.5ml) administer into check by mouth daily; calcium carbonate 1250 mg/5ml (100 mg/ml elemental calcium) oral suspension 2.5 ml into bag 3 time daily by mouth; oxycodone 5 mg/5ml oral solution 0.5 mg (0.5ml) by mouth or through g-tube for breakthrough pain not controlled by acetaminophen every 6 hours as needed by mouth. However, Patient #8's medication profile showed she was to receive multiple medications which included: Captopril 1mg/ml 0.4 ml through her g-tube or by mouth two times daily; Miralax oral powder for reconstitution 17 gm/scoop 2 gms into feed bag one time daily; Retacrit 4000 units/ml preservative-free injectable solution administer 880 units (0.22mls) subcutaneously two times weekly; Calcitriol 1 mcg/ml oral liquid 1mcg (1ml) administer into cheek daily by mouth; Calcium Carbonate 1250 mg/5ml (100 mg/ml elemental calcium) oral suspension 7.5 ml into bag one time daily by mouth. Further review of Patient #8 medication profile showed Patient #8's oxycodone was discontinued on 10/19/21. There was no evidence orders had been obtained by the physician to make these medication changes. Clinical record review revealed no evidence the agency had contacted the physician to obtain a physician order for any of the medication changes for Patient #8. During an interview on 11/16/21 at 2:07 p.m., Patient #8's foster mother, (RN #5), stated when she received after visit instructions from the doctor for Patient #8, she would send these instructions to the agency and the other nurses caring for Patient #8 as she assumed all of these instructions were orders to be followed. 2. The clinical record for Patient #9 was reviewed on 11/03/2021. The POC for the certification period dated 10/16/21 to 12/14/21 revealed a start of care date of 10/16/21; diagnoses included chronic respiratory failure (a condition that makes it difficult to breathe or get enough oxygen into the blood), dependence on a respirator ventilator (a machine that moves air in and out of your lungs), tracheostomy (an opening surgically created through the neck to allow direct access to the respirator breathing tube), epilepsy (a brain disorder that causes recurrent seizures), Ventriculoperitoneal Shunt (a surgically inserted drain used to drain excess fluid from the brain), gastrostomy (a surgically inserted tube into the abdominal wall used for feeding) and hearing loss. POC orders included RN visits up to 24 hours daily for tracheostomy care, gastrostomy tube (gt) feedings, vital signs, monitoring, and assessment and CNA visits up to seven hours daily for personal care, light housekeeping and continuous line of sight monitoring. a) The agency failed to ensure communication with the physician to obtain proper medication administration orders after Patient #9 had experienced a change in condition. Specifically, the agency failed to contact the physician of record to report Patient #9 had begun to experience an increase in tracheal secretions and failed to obtain medication orders for antibiotic treatment in relation to the change. Review of the ‘Peds Visit AM’ note completed by RN # 4 on 11/02/21 showed the RN noted Patient #9 had an increase in tracheal secretions from the patient's baseline. Review of the ‘Peds Visit PM’ note completed by RN #5 on 11/02/21, also showed RN #5 had contacted the patient’s pulmonologist to report Patient #9 had to be suctioned through the tracheostomy more frequently, every 1 to 2 hours, for thick yellow secretions. RN #5 also noted she had received orders to start antibiotics. Further review of the patient’s medication administration record for the month of November 2021 showed Patient #9 was receiving Amoxicillin 400 mg per 5ml and to give 5.5ml through the GT three times a day for 7 days. However, additional record review revealed no evidence that Patient #9’s physician of record was contacted regarding the change in the patient’s condition. Furthermore, there was no evidence the agency had ever obtained an order for the Amoxicillin medication that was added to the medication administration record. 3. The clinical record for Patient #10 was reviewed on 11/15/21. The POC for the certification periods 9/5/21 through 11/3/21 and 11/4/21 through 1/2/22 revealed a start of care date of 1/8/21; diagnoses included Seizures, gastrostomy status, esophageal reflux, atrial septal defect, patent ductus arteriosus, protein-calorie malnutrition, chronic obstructive pulmonary disease, hypoxemia, developmental delays, anisometropia and eczema. POC orders included RN services up to 24 hours a day for g-tube feedings, medication administration, vital signs, monitoring, assessment, and continuous line of sight supervision and nursing interventions during seizure activity and CNA up to six times a day for assistance with personal care, light housekeeping and continuous line of sight monitoring. a. The agency failed to ensure communication with the physician with changes in the patient's condition. Specifically, the agency failed to communicate with the physician Patient #10 was vomiting with her overnight g-tube feedings. Review of Ped visit notes dated 9/5/21 through 11/13/21 revealed RN #5 documented Patient #10 vomited during the 4:00 p.m. to 8:00 a.m. shift on 10/17/21, 10/18/21, 10/19/21, 10/20/21, 10/21/21, 10/22/21, 10/31/21, 11/1/21, 11/2/21, 11/3/21, 11/4/21, 11/5/21, 11/6/21, 11/7/21 and 11/8/21. RN #4 documented Patient #10 vomited on 11/11/21, on 11/12/21 and 11/13/21 and on 11/12/21 and 11/13/21 RN #4 also documented she stopped Patient #10's g-tube feeding for 30 minutes. Clinical record review revealed no evidence RN #4 or #5 documented any communication regarding Patient #10's vomiting multiple days. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated she was also the mother/foster mother of Patient's #6 through #12 and if any of these patients developed a change of condition, RN #5 would inform the physician of the child's change of condition, as the child's mother, when she was not working during the day. RN #5 stated she emailed the after-visit instructions she received from the child's physician to the agency and other nurses working with the child.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 484.80, HOME HEALTH AIDE SERVICES, was out of compliance. Specifically, the agency failed to provide physician ordered certified nurse aide (CNA) services by qualified staff. The extent of the failures showed the deficient practice had the potential to affect all patients served by the agency. The following standard level deficiencies were also cited: G786: Unqualified HH Aide Providing Services - The agency failed to ensure a CNA who was qualified through formal training, testing and certification through the Colorado State Department of Regulatory Agencies (DORA) to function as a CNA provided care and services to patients (Employees #10, #21 and #22). G800: Services Provided by Home Health Aide - The agency failed to ensure CNAs provided services as ordered by the physician, included in the plan of care and were consistent with home health aide training for 1 of 4 patients reviewed receiving intermittent care (Patient #19) and 1 of 18 private duty nursing patients (Patient #18). G808: Supervisory Visits - The agency failed to ensure CNA supervision occurred at least every 14 days for 18 of 18 patients receiving CNA services (Patients #1 through #19).

Unqualified HH aide providing services CFR(s): 484.80(f)(2) (2) Permitted an individual who does not meet the definition of a "qualified home health aide" as specified in paragraph (a) of this section to furnish home health aide services (with the exception of licensed health professionals and volunteers); or This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure a certified nurse aide (CNA) who was qualified through formal training, testing and certification through the Colorado State Department of Regulatory Agencies (DORA) to function as a CNA provided care and services to patients (Employees #10, #21 and #22). REGULATORY REFERENCE The Colorado Nurse Aide Practice Act (Article 12-38) defines the scope of practice for a nurse aide or CNA as the performance of services requiring the education, training, and skills necessary for the certification as a nurse aide (section 12-38.1-102: Definitions (5). Curriculum content for nurse aide training programs provide only an elementary level of knowledge and skills for infection control measures, safety and emergency procedures, basic nursing tasks, personal care skills and basic restorative services (section 12-38.1-108). According to CCR Title 12 Professions and Occupations, Article 38.1, Nurse Aides, 12-38.1-102. Definitions (in part): As used in this article, unless the context otherwise requires: (1) "Approved education program" means: (a) A course of training conducted by an educational or health care institution which implements the basic nurse aide curriculum prescribed and approved by the board. (2) "Board" means the state board of nursing in the division of professions and occupations in the department of regulatory agencies, created in section 12-38-104. (3) "Certified nurse aide" means a person who meets the qualifications specified in this article and who is currently certified by the board. Only a person who holds a certificate to practice as a nurse aide in this state pursuant to the provisions of this article shall have the right to use the title "Certified Nurse Aide" and its abbreviation, "C.N.A.". According 6 Colorado Code of Regulations (CCR) 1011-1 Chap. 26 (3.29) for home care "Skilled home health services" means health and medical services furnished in the consumer's temporary or permanent place of residence that include wound care services; use of medical supplies including drugs and biologicals prescribed by a physician; in-home infusion services; nursing services; or certified nurse aide services that require the supervision of a licensed or certified health care professional acting within the scope of his or her license or certificate; occupational therapy; physical therapy; respiratory care services; dietetics and nutrition counseling services; medication administration; medical social services; and speech-language pathology services. "Skilled home health services" does not include the delivery of either durable medical equipment or medical supplies. According to 6 CCR 1011-1 Chap. 26 (7.8) (A) (B) (1), for home care under "Personnel": (A) Each employee and contracted staff shall possess the education and experience to provide services in the homes of consumers in accordance with agency policy, state practice acts and professional standards of practice as set forth in this chapter. (B) Licensed, registered or certified healthcare providers shall, at a minimum, meet the following requirements: (1) Be qualified as a physician, pharmacist, physician assistant, nurse practitioner, clinical social worker, social worker, physical therapist, physical therapist assistant, occupational therapist, occupational therapist assistant, respiratory therapist, registered nurse, licensed practical nurse, massage therapist, certified nurse aide or other provider licensed, registered or certified by the Colorado Department of Regulatory Agencies (DORA)." 1. The personnel record for Employee #22 was reviewed on 11/16/21 and revealed a hire date of 7/19/21. Employee #22 signed a job description for the position of CNA on 7/19/21. a) The agency failed to ensure Employee #22 was qualified as a CNA through the completion of CNA classes and DORA prior to the provision of CNA services. Review of Employee #22's certificate of completion for nurse aide training revealed Employee #22 was to graduate on 12/13/21, five months after her hire date and one month after the completion of the survey. Review of Employee #22's personnel record revealed no evidence a DORA certification check had been completed on Employee #22 prior to the provision of services. Review of the DORA professional license verification website on 11/17/21 revealed Employee #22 had no CNA certification. During an interview on 11/16/21 at 12:50 p.m., the Director of Nursing stated Employee #22 had been providing CNA services to three patients since her hire date in July. The DON provided a weeks worth of visit notes from 11/1/21 through 11/7/21 completed by Employee #22 and stated this was the care Employee #22 had completed since her hire date. During further interview on 11/16/21, the DON stated the agency did not have a DORA check for Employee #22. The DON further stated Employee #22 should have had a temporary CNA certification until her test in December 2021. 2. The personnel record for Employee #21 was reviewed on 11/16/21 and revealed a hire date of 7/31/21. Employee #21 signed a job description for the position of CNA on 7/31/21. a) The agency failed to ensure Employee #21 was qualified as a CNA through DORA prior to the provision of CNA services. Review of Employee #21's certificate of completion for nurse aide training revealed Employee #21 graduated from a CNA training program on 7/25/21. Review of Employee #21's personnel record revealed no evidence a DORA certification check had been completed on Employee #21 prior to the provision of services. Review of the DORA professional license verification website on 11/17/21 revealed Employee #21 had no CNA certification. During an interview on 11/16/21 at 12:50 p.m., the DON stated Employee #21 had been providing CNA services to three patients since his hire date in July. The DON provided a weeks worth of visit notes from 10/27/21 through 11/3/21 completed by Employee #21 and stated Employee #21 had provided the same care every week since his hire date. During further interview on 11/16/21, the DON stated the agency did not have a DORA check for Employee #21. The DON further stated Employee #21 should have had a temporary CNA certification until his test in December 2021. 3. The personnel record for Employee #10 was reviewed on 11/16/21 and revealed a hire date of 12/30/14. Employee #10 had signed a job description for CNA on 1/20/15. a) The agency failed to ensure Employee #10 was qualified as a CNA through DORA prior to the provision of CNA services. Review of a DORA check found in Employee #10's personnel record revealed her CNA certification had expired on 1/31/21. Review of the DORA professional license verification website on 11/17/21 revealed Employee #10's CNA certification expired as of 1/31/21 and she was no longer qualified to provide CNA services. Review of Patient #19's record revealed Employee #10 had provided CNA visits three times weekly from 9/8/21 through 10/24/21 and then five times weekly from 10/25/21 through 11/1/21. During an interview on 11/16/21 at 9:40 a.m., the DON stated she was unaware that Employee #10's CNA certification expired on 1/31/21. 4. During an interview on 11/16/21 at 1:30 p.m., the administrator and DON admitted the lack of CNA certification verification was a problem and it would be addressed. The administrator and DON stated they had a process in place to address verification of certifications and licenses but the unexpected passing of the agency's human resource employee and COVID-19 led to the agency failing to verify CNA certifications prior to the provision of care.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure certified nursing aides (CNAs) provided services as ordered by the physician, included in the plan of care and were consistent with home health aide training for 1 of 4 home health care patients (Patient #19) and 1 of 18 private duty nursing patients (Patient #18). AGENCY POLICY According to the agency policy titled, "Home Health Aides Competency, Supervision, and Assignment," dated 2007 (in pertinent parts): "-The Registered Nurse or other appropriate supervisor makes the Initial Assessment visit to the patient, evaluates the care needed, develops the plan of care and assignment form and instructs the home health aide prior to the first visit. -The supervising professional obtains the patient caregiver's input into the home health aide plan of care, including all task to be performed during each scheduled time period. -The Registered Nurse or other appropriate professional visits the patient's home to evaluate the patient's care needs and the aide's performance every 14 days. The plan of care is reviewed and changed as needed. -The plan of care includes services, frequency relevant diagnoses and prognoses, functional limitations, mental status, activities, nutritional requirements, safety measures, allergies and instructions for reporting changes in condition and documentation." 1. The clinical record for Patient #19 was reviewed on 11/1/21. The Plan of Care (POC) for the certification period dated 9/8/21 to 11/6/21, revealed a start of care date of 9/8/21; diagnoses included Non-Hodgkin lymphoma, essential hypertension, atrial fibrillation, and osteoarthritis. POC orders included skilled nursing (SN) every other week for 9 weeks for medication set up and management, and patient monitoring and teaching; CNA visits three times a week for 9 weeks to assist with activities of daily living (ADL) including, showers, transfers, skin care, nail care, shaving, medication reminders, exercises, shopping, meal preparation, and light housekeeping; physical therapy (PT) visits, no frequency listed, to assess functional status, home safety, assess rehabilitation potential to determine the need for gait training, safety precautions, pain management, exercises, including a home exercise program (HEP), balance/coordination training and transfer training; and occupational therapy (OT) visits, no frequency listed, to assess functional status, home safety, ADL training, safety precautions, and exercises including a HEP. a) The agency failed to ensure the CNA provided care in accordance with the written plan of care established by the physician. Review of the CNA care plan dated 9/8/21 completed by RN #17 revealed the CNA was to assist Patient #19 with showers, skin care, nail care, shaving, dressing, medication reminders, transfers, bed making and light housekeeping three times a week and linen change one time a week. Review of CNA notes dated 9/10/21 to 11/1/21 completed by CNA #10 revealed CNA #10 documented she assisted Patient #19 with the following tasks not on the CNA care plan: shampoo hair, comb hair, range of motion (ROM), and meal set up during all 18 visits (9/10/21, 9/13/21, 9/15/21, 9/17/21, 9/20/21, 9/22/21, 9/24/21, 9/27/21, 9/29/21, 10/1/21, 10/4/21, 10/6/21, 10/8/21, 10/25/21, 10/26/21, 10/27/21, 10/28/21, 10/29/21 and 11/1/21) she provided care to Patient #19. Further review of these 18 CNA notes completed by CNA #10 revealed CNA #10 failed to document providing Patient #19 with assistance with transfers at each visit and with linen changes once a week, without explanation of why these tasks were not completed during all 18 visits she provided care to Patient #19. Review of CNA notes dated 10/12/21, 10/14/21, 10/19/21, and 10/21/21 completed by CNA #18 revealed CNA #18 documented she assisted Patient #19 with the following tasks not on the CNA care plan: shampoo hair, comb hair, ROM, and meal set up during the four visits she provided care to Patient #19. Further review of these four CNA notes revealed CNA #18 failed to document providing Patient #19 with assistance with transfers at each visit and linen changes once a week without explanation of why these tasks were not completed during the four visits she provided care to Patient #19. Further review of Patient #19's record failed to reveal any documentation of updates to Patient #19's CNA care plan to reflect Patient #19 home health aide needs. During a home visit on 11/1/21 at 10:32 a.m., Patient #19 stated the CNAs assisted him with showers, washing and combing his hair, shaving, dressing, transferring in and out of the shower, meal preparation, medication reminding, application of lotions/medicated ointments, and light housekeeping including changing the sheets as needed. During a home visit on 11/1/21 at 11:02 a.m., CNA #10 stated she followed the CNA care plan to know what tasks to assist a patient with during her visit. CNA #10 stated per the CNA care plan she had for Patient #19, she assisted Patient #19 with: showers, hair care, including shampooing and combing Patient #19's hair, dressing assistance, meal preparation, medication reminder, skin care, including applying lotions and medicated ointments, light housekeeping, including bed making and linen changing, and ROM exercises. CNA #10 explained that by helping Patient #19 with ROM exercises what she meant was she reminded Patient #19 to complete exercises as instructed on the exercises sheets provided by Patient #19's daughter. CNA #10 reviewed the CNA Care Plan dated 9/8/21 completed by RN #17 and acknowledged shampooing, hair care, ROM and meal preparation were tasks not assigned on this care plan. CNA #10 stated she had a different CNA care plan that she was following, and shampooing, hair care, ROM and meal preparation were tasks assigned on that care plan for her to assist Patient #19 with each visit. CNA #10 stated she was changing Patient #19's linens when needed and at least weekly but she must have forgotten to document completing this task. During an interview on 11/2/21 at 1:52 p.m., RN #17 stated the CNA was helping Patient #19 with showers, skin care, nail care, shaving, dressing, medication reminding, assistance with transfers, including transfers to/from a shower chair and light housekeeping. RN #17 stated due to the CNA frequency increasing from three days a week to five days a week, RN #17 was going to add a meal set up to the CNA care plan. RN #17 stated once PT/OT discharged Patient #19 from their services, she would probably add assistance with ambulation and exercises to the CNA care plan. RN #17 stated the CNA care plan and the form the CNA document on in the electronic medical record did not have a spot for exercise, thus, the best place to mark this task for the CNA to complete this task with a patient was under ROM. RN #17 stated ROM could be passive or active, and active ROM could include the patient completing exercises on their own with reminders to complete the exercises provided by the CNA. RN #17 stated she felt Patient #19's daughter had made a care plan of her own that the CNAs were possibly following the daughter's care plan which may have led to some of the discrepancies between what tasks the CNA were completing compared to assigned tasks. b. The agency failed to ensure the CNA provided care in accordance with their training. Further review of Patient #19's POC for the certification period dated 9/8/21 to 11/6/21, revealed Patient #19 received the following medications: vitamin D3, Tamsulosin, Acetaminophen, lactobacillus acidophilus, Lidoderm patch, oyster shell calcium, Voltaren arthritis pain gel, aspirin, Atorvastatin, Nitroglycerin, Lisinopril, Plavix and Metoprolol Succinate. Review of a Departments of Veterans Affairs Consult dated 10/5/21 at 7:45 a.m. for Patient #19 revealed Patient #19's active outpatient medications were as follows: Aspirin, Atorvastatin Calcium, Calcium, Clopidogrel Bisulfate, Diclofenac (Voltaren) gel, Lactobacillus Acidophilus, Lidocaine ointment, Lisinopril, Metoprolol Succinate, multivitamins with minerals, spironolactone, and Tamsulosin HCL. During a home visit on 11/1/21 at 10:32 a.m., Patient #19 stated CNA #10 applied medicated ointment to his left hip and shoulder after each shower to help reduce his pain. Patient #19 stated CNA #10 applied lidocaine ointment to his left hip (Patient #19 sustained a fall prior to his 9/8/21 admission which resulted in a left hip fracture which required a surgical repair) and Voltaren arthritis pain gel to his left shoulder. During a home visit on 11/1/21 at 11:02 a.m., CNA #10 confirmed she applied lidoderm ointment to Patient #19's left hip and Voltaren arthritis pain gel to his left shoulder after she helped Patient #19 to shower. CNA #10 stated RN #17 had not provided her with any education on the technique to use nor was she provided any education by RN #17 on how much of each cream to use. CNA #10 stated she wore gloves when she applied the lidoderm and Voltaren pain ointments and changed her gloves between applications of each type of medicated ointment. CNA #10 stated she was aware she was not allowed to administer medication to a patient but did not realize applying medicated ointment required education, delegation and oversight supervision by the RN. During an interview on 11/2/21 at 1:13 p.m., RN #17 stated she was unaware that CNA #10 was applying lidoderm ointment to Patient #19's left hip and Voltaren arthritis pain gel to Patient #19's left shoulder. RN #17 stated CNA #10 was not allowed to apply medicated ointment and RN #10 had not completed training nor competencies with CNA #10 to educate her on how to use the dosage card provided for the Voltaren arthritis pain gel to know how much of the Voltaren arthritis pain gel to apply to Patient #19's left shoulder. Further, RN #17 had not provided CNA #10 with education on how much of the lidoderm ointment to use or the application technique CNA #10 should have been used when applying both ointments to avoid absorbing the medication into her own skin. RN #17 stated Patient #19's daughter probably told CNA #10 to apply the two ointments for Patient #19. Review of CNA visits dated 9/10/21 to 11/1/21 completed by CNA #10 (total of 18 visits) failed to reveal that CNA #10 documented that she applied lidoderm ointment to Patient #19's left hip or Voltaren arthritis pain gel to Patient #19's left shoulder. During an interview on 11/17/21 at 10:42 a.m., the DON stated that she had taken a step back from tasks in the agency this past year due to various personal reasons and the quality assurance checks that she normally would do, were not done when she had decreased her hours. The DON stated the agency needed to improve the oversight of documentation and the DON had already begun inservicing the staff on the importance of writing a complete and accurate note. The DON stated the agency's plan was to hire a quality assurance nurse to help get the agency back on track, especially with documentation, POC and assessments/reassessments. 2. The clinical record for Pediatric Patient #18 was reviewed on 11/3/21. The Plan of Care for the certification period dated 9/16/21 to 11/12/21 revealed a start of care date of 9/16/21; diagnoses included failure to thrive, non-traumatic intracerebral hemorrhage, convulsions and gastrostomy status. Plan of Care orders included RN visits up to 24 hours a day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment and CNA visits up to six hours per day for assistance with activities of daily living (ADLs) and light housekeeping although CNA services were on hold from the start of services to the date of review (11/3/21). a) The agency failed to ensure CNA services followed the Plan of Care as ordered by the physician. Review of the Plan of Care for the period dated 9/16/21 to 11/14/21 revealed the physician had ordered CNA services to be on hold. Further review showed CNA services were to include bathing, dressing, hair care, skin care, nail care, oral care, incontinence care, transfer assist, mobility, laundry, light housekeeping, equipment care and continuous line of sight monitoring. Record review revealed no evidence a CNA care plan had been developed for Patient #18. Further review revealed no evidence a CNA had documented the provision of any services. Review of RN daytime visit notes from 9/16/21 to 11/3/21 revealed the RN documented a CNA (no name documented) had provided services for Patient #18. Specifically: On 9/20/21, the CNA provided transfer assistance. On 9/26/21, the CNA provided a shower and dressing assistance. On 9/27/21, the CNA provided a diaper change and dressing assistance. On 10/2/21, the CNA provided assistance to the RN with personal care. On 10/3/21, the CNA provided assistance to the RN with personal care. On 10/4/21, the CNA provided a shower. On 10/9/21, the CNA provided assistance to the RN with personal care. On 10/10/21, the CNA provided a shower. On 10/11/21, the CNA provided dressing assistance. On 10/14/21, the CNA provided assistance to the RN with personal care. On 10/16/21, the CNA provided assistance to the RN with personal care. On 10/17/21, the CNA provided a diaper change and dressing assistance. On 10/18/21, the CNA provided a shower, diaper change and dressing assistance. On 10/19/21, the CNA provided assistance to the RN with personal care. On 10/23/21, the CNA provided assistance to the RN with personal care. On 10/24/21, the CNA provided assistance to the RN with personal care. On 10/25/21, the CNA provided a diaper change and dressing assistance. On 10/26/21, the CNA provided assistance to the RN with personal care. On 10/28/21, the CNA provided assistance to the RN with personal care. On 10/30/21, the CNA provided assistance to the RN with personal care. On 10/31/21, the CNA provided assistance to the RN with personal care. On 11/1/21, the CNA provided a shower and dressing assistance. On 11/2/21, the CNA provided assistance to the RN with personal care. During an interview on 11/4/21 at 9:00 a.m., RN #7 stated Patient #18's CNA services were on hold since his start of care and was not receiving those services. RN #7 further stated there was a CNA providing service to the five patients residing in the home.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech-language pathology services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in §484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure certified nurse aides (CNA) supervision occurred at least every 14 days for 18 of 18 patients receiving CNA services (Patients #1 through #19). AGENCY POLICY According to the agency policy titled, "Home Health Aides Competency, Supervision, and Assignment," dated 2007 (in pertinent parts): "The practice of home health aides must be supervised by Registered Nurses or other appropriate professionals. 3. The Registered Nurse or other appropriate professional visits the patient's home to evaluate the patient's care needs and the aide's performance every 14 days. The plan of care is reviewed and changed as needed. Supervisory visits for patients receiving skilled services are performed every 14 days in the patient's home." 1. The clinical record for Patient #1 was reviewed on 11/1/21. The Plan of Care for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnoses included spastic quadriplegic cerebral palsy, unspecified convulsions, and obstructive sleep apnea. Plan of Care orders included skilled nurse (SN) services up to sixteen hours per day and SN services up to eight hours per day for a total of up to 24 hours per day for gastrostomy tube feedings, medication administration, monitoring, vital signs (VS), and assessments, and certified nurse aide (CNA) services up to five hours per day for assistance with personal cares and light housekeeping. a) The SN failed to supervise the CNA every 14 days. Review of the clinical record dated 10/22/21 to 12/20/21 revealed Patient #1 was receiving CNA services daily for assistance with personal care and light housekeeping. Further review revealed the CNA for Patient #1 would have been due for supervisory visits on 11/5/21, however, there was no documentation in the clinical record of CNA supervision by the SN responsible for Patient #1's care. 2. The clinical record for Patient #2 was reviewed on 11/3/21. The Plan of Care for the certification period dated 10/10/21 to 12/8/21 revealed a start of care date of 6/17/20; diagnoses included spastic quadriplegic cerebral palsy, disorders of the lung, encephaolpathy, epilepsy, hypoxemia, and feeding difficulties. Plan of care orders included SN services up to sixteen hours per day for one hour for nine weeks and up to eight hours per day for one hour for nine weeks for tracheostomy and ventilator care, gastric tube (GT) feedings, vital signs, monitoring, and assessments, and CNA services up to seven times a day for nine weeks to assist with personal care and light housekeeping. a) The SN failed to supervise the CNA every 14 days. Review of the clinical record dated 10/10/21 to 12/8/21 revealed Patient #2 was receiving CNA services daily for assistance with personal care and light housekeeping. Further review of the clinical record revealed no documented evidence the SN for Patient #2 had conducted a CNA supervisory visit between 10/10/21 and 11/3/21. 3. The clinical record for Patient #3 was reviewed on 11/2/21. The Plan of Care for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnoses included post traumatic seizures, hemiplegia (paralysis of one side of the body), and a gastrostomy tube (G-tube). Plan of care orders included SN services up to 24 hours a day for 60 days for g-tube feedings, medication administration, vital signs, monitoring, and assessments, and CNA services up to six hours a day for 60 days for assistance with personal care and light housekeeping. a) The SN failed to supervise the CNA every 14 days. Review of the clinical record dated 10/22/21 to 12/20/21 revealed Patient #3 was receiving CNA services daily for assistance with personal care and light housekeeping. Further review revealed the CNA for Patient #3 would have been due for supervisory visits on 11/5/21, however, there was no documentation in the clinical record of CNA supervision by the SN responsible for Patient #3's care. 4. The clinical record for Patient #19 was reviewed on 11/1/21. The Plan of Care for the certification period of 9/8/21 to 11/6/21 revealed a start of care date of 9/8/21; diagnoses included Non-Hodgkin's Lymphoma, hypertension, and atrial fibrillation (irregular heartbeat). Plan of Care orders included SN services every other week for nine weeks for medication set up and management, and CNA services three times a week for nine weeks for assistance with activities of daily living. a) The SN failed to supervise the CNA every 14 days. Review of the clinical record dated 9/8/21 to 11/6/21 revealed no documented evidence the SN for Patient #19 had conducted a CNA supervisory visit between 9/8/21 and 11/6/21. Similar findings of failure to provide CNA supervisory visits every 14 days for patient receiving skilled services were found for Patients #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #17, and #18. During an interview on 11/2/21 at 11:30 a.m., RN #9 stated she did not do formal supervisory visits because both she and the CNA for Patients #1 through #5 were always together in the home during their shifts and she saw everything the CNA did every day. During an interview on 11/2/21 at 1:13 p.m., RN #17 stated she was supposed to supervise the CNA providing care to Patient #19 every two weeks. She further stated she did not document her supervisory visits and did not have a reason why she didn't document her visits. During an interview on 11/1/21 at 8:50 a.m., the administrator stated the agency's expectation was to provide supervisory visits on skilled cases every two weeks. She further stated that the supervisory visits could be documented within the SN visit notes or as a stand alone note in the medical record.

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 interview and record review the Administrator of the agency failed to organize, manage, and administer the agency's resources in order to attain and maintain the highest practicable functional capacity of the agency, 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. AGENCY POLICY According to the policy titled, "Agency Information," undated (in pertinent parts): "Objectives: 1. To provide comprehensive services to our patients. 2. To provide personalized care designed according to the patient's needs. 5. To maintain adequate staffing and supervision of care and services provided within the geographic area served. 6. To comply with all appropriate state and federal standards and regulations." 1. Interview and record review showed the agency's lack of an established system for effectively ensuring and accounting for the provision of care and services for patients who had been admitted to the agency contributed to systemic failures in all aspects of patient care and services. Specifically: a) Interview and record review showed the Administrator failed to ensure all patient care was provided only as ordered by a physician as part of a comprehensive plan of care for each patient. Cross reference citation of systemic failure potentially affecting all patients served by the agency under the Condition of Participation 484.60, CARE PLANNING, COORDINATION, QUALITY OF CARE: G572 - Standard: Plan of Care - The agency failed to ensure each patient received home health services in accordance with the written plan of care established and periodically reviewed by a physician for 18 of 18 pediatric patients reviewed who received private duty nursing (PDN) services (Patients #1 through #18). G574 - Standard: Plan of Care Must Include the Following - The agency failed to ensure each patient's Plan of Care (POC) covered the patient's status, all pertinent treatments and medications and the frequency and duration of visits for 18 of 18 pediatric patients reviewed receiving private duty nursing (PDN) (Patients #1 through #18). b) Interview and record review showed the Administrator failed to ensure registered nurses (RNs) routinely assessed a patient who received peritoneal dialysis (PD) and complained of abdominal pain. Furthermore, the agency failed to ensure registered nurses (RNs) coordinated with the physician and documented an accurate and complete description of care provided. Cross reference citation of systemic failure potentially affecting all patients served by the agency under the Condition of Participation 484.75 SKILLED PROFESSIONAL SERVICES: G706: Interdisciplinary Assessment of the Patient - The agency failed to ensure ongoing interdisciplinary assessment occurred by the Registered Nurse (RN) to re-evaluate the nursing needs for 1 of 1 pediatric patients receiving PD (Patient #8). G716: Preparing Clinical Notes - The agency failed to ensure staff provided complete and accurate clinical notes for 18 of 18 PDN patient records reviewed (Pediatric Patients #1 through #18). G718: Communication with Physicians - The agency failed to ensure nursing professional services communicated with the physician of changes in condition for 1 of 18 pediatric patients (Patient #8) and the agency failed to ensure nursing professional services communicated with the physician to obtain orders for changes to the Plan of Care for 7 of 18 pediatric patients reviewed receiving PDN services (Patients #1, #6, #8, #9, #10, #14, and #18). c) Interview and record review showed the Administrator failed to ensure only qualified staff were scheduled and assigned to carry out patient care and services. Cross reference citation of systemic failure potentially affecting all patients served by the agency under the Condition of Participation 484.80, HOME HEALTH AIDE SERVICES: G786: Unqualified Home Health Aide Providing Services- The agency failed to ensure a certified nurse aide (CNA) who was qualified through formal training, testing and certification through the Colorado State Department of Regulatory Agencies (DORA) to function as a CNA provided care and services to patients. G800: Services Provided by Home Health Aide - The agency failed to ensure certified nursing aides (CNAs) provided services as ordered by the physician, included in the plan of care and were consistent with home health aide training for 1 of 4 home health care patients (Patient #19) and 1 of 18 private duty nursing patients (Patient #18). G808: Onsite Supervisory Visit Every 14 Days - The agency failed to ensure CNA supervision occurred at least every 14 days for 18 of 18 patients receiving CNA services (Patients #1 through #19).supervisory visit no less frequently than every 14 days for 18 of 18 private duty nursing (PDN) patients (Patients #1 through #18), and 1 of 5 home health agency patients (Patient #19) d) Interview and record review showed the Administrator failed to establish and maintain an accurate account of patient care and services and failed to maintain an effective method of tracking and communicating the current medical status of patients receiving care and services from the agency. Cross reference citation of systemic failure potentially affecting all patients served by the agency under the Condition of Participation 484.110, CLINICAL RECORDS. The agency failed to ensure each patient's clinical record was accurate and adhered to current clinical record documentation standards of practice for 17 of 18 patients who received private duty nursing services (Patient #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #12, #13, #14, #15, #16, #17 and #18). Clinical record review and interview revealed the agency's patient information contained in the clinical record was not accurate and did not adhere to current clinical record documentation standards of practice for 17 of 18 patients who received private duty nursing services. 2. In summary, the Administrator failed to: - Ensure each patient received home health services in accordance with the written plan of care established and periodically reviewed by a physician. - Ensure each patient's POC covered the patient's status, all pertinent treatments and medications and the frequency and duration of visits. - Ensure ongoing interdisciplinary assessment occurred by the RN to re-evaluate the nursing needs of patients. - Ensure staff provided complete and accurate clinical notes. - Ensure nursing professional services communicated with the physician with changes in patient's conditions. - Ensure only qualified staff were scheduled and assigned to carry out patient care and services - Ensure CNAs provided services as ordered by the physician, included in the plan of care and were consistent with home health aide training. - Ensure all home health aides (HHA) for patients who received skilled nursing care provided a documented onsite supervisory visit no less frequently than every 14 days. - Ensure each patient's clinical record was accurate and adhered to current clinical record documentation standards of practice. The state agency (SA) determined these systemic failures posed an immediate risk to the health, safety and welfare of all patients being served by the agency and on 11/9 /21 at 2:56 p.m. the agency was advised these failures created a situation of Immediate Jeopardy. The agency's Administrator was advised to develop a plan to immediately address the circumstances of the Immediate Jeopardy, and while two separate proposed plans were presented, neither plan contained sufficient information, direction and approach to remove the identified concerns. No additional plans to address the Immediate Jeopardy situation were presented by the agency and on 11/17/21 the survey was concluded with the situation of Immediate Jeopardy unaddressed.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on interview and record review, it was determined the Condition of Participation 484.110, CLINICAL RECORDS, was out of compliance. The agency failed to ensure each patient's clinical record was accurate and adhered to current clinical record documentation standards of practice for 17 of 18 patients who received private duty nursing (PDN) services (Patient #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #12, #13, #14, #15, #16, #17 and #18). A. Interview and record review revealed the agency failed to ensure PDN patients' records contained accurate clinical information and adhered to current clinical record documentation standards of practice. Specifically, record review revealed agency nurses often copied and pasted narratives in their daily notes, which failed to provide an accurate description of their patient's status and treatments provided to the patient during the shift. Further record review revealed the agency failed to ensure patients' clinical records did not contain conflicting information on the plan of care (POC) and in the clinical notes which made it difficult to assess the amount of nursing care a patient required and the patient's status at a given time. The agency failed to ensure patients' POC contained accurate documented information on their diagnoses, medications, psychosocial status, advanced directives, durable medical equipment and treatment interventions. The agency consistently failed to obtain and document physician orders for changes in patients' care including but not limited to medication changes, gastrostomy feeding flow rates, and durable medical equipment used by patients. The agency's failure to have an ongoing quality assurance program led to many of these failures to continue to occur. During an interview on 11/1/21 at 10:36 a.m., the administrator stated all patient records were located on the agency's electronic medical records (EMR) system. The administrator stated the initial comprehensive assessments, recertifications, certified nursing assistant (CNA) care plans, CNA supervisory visits, missed visits and verbal orders would all be found in the EMR. She also stated several people were responsible for the quality assurance (QA) process of reviewing skilled nursing (SN) and CNA notes which included the administrator, the director of nursing (DON), and two licensed practical nurses (LPN) (Employees #19 and #20). The administrator stated the EMR system would prompt the staff/QA reviewers when a patient was due for recertifications but that she also had a spreadsheet she used to track when the recertifications were due as a backup system. During an interview on 11/17/21 at 9:59 a.m., Employee #19 stated prior to the agency taking on caring for patients with PDN needs, one of her roles was to assist the agency with QA. She stated she would help advise the RNs on how to complete a specific section of the assessments, but she was aware of her scope of practice as a LPN, so she could advise but never answer a specific question. Employee #19 stated once the agency took patients who required PDN services she continued to help with QA but most of her time was focused on scheduling all employees for both the home health services and PDN services. Another responsibility Employee #19 stated she had was to fax physician orders for patients. She stated the physicians' for PDN patients rarely called the agency directly with orders for the PDN patients. Instead nurses would call or email the agency with any changes for the patient. The physician orders Employee #19 faxed were written by the DON and faxed to the physician for signature. During an interview on 11/9/21 at 8:32 a.m., the DON stated patients receiving PDN services from the agency had frequent physician visits in person and virtually with changes to their POC. The DON stated the family and/or RNs caring for the PDN patients would email copies of the patients' after visit summaries from these visits which reflected these changes and/or send pictures of prescription bottles with the new dosage and instructions for changed medications to the agency and the agency updated the medication administration record (MAR) and the patient's medication profile, however, the agency would not obtain orders for the changes. During an interview on 11/17/21 at 10:42 a.m., the DON stated that she had taken a step back in regards to her involvement with the agency which led to issues with clinical records being accurate. The DON acknowledged the clinical records of patients receiving PDN services did not reflect accurate information or adhere to clinical record documentation standards of practice. The DON stated moving forward, the agency would obtain physician orders for all changes made to a patient's POC and the agency was hiring a QA nurse to "tighten up " the documentation. 1.The clinical record for pediatric Patient #8 was reviewed on 11/8/21. The Plan of Care (POC) for the certification period 9/19/21 to 11/17/21 revealed a start of care date of 5/27/20; diagnoses included dependence on renal dialysis, dysphagia, anemia in chronic kidney disease, unspecified lack of expected normal physiological development in childhood and congenital hypothyroidism. Plan of Care orders included RN/licensed practical nurse (LPN) up to 24 hours a day for peritoneal dialysis (PD), gastrostomy tube feedings, medication administration, vitals, monitoring and assessment; and CNA up to six times a day for assistance with personal care and light housekeeping. a. The agency failed to ensure Patient #8's clinical record contained an accurate description of Patient #8's status. Review of a Ped Visit note completed on 10/28/21 for the 8:00 a.m. to 4:00 p.m shift by RN #4 revealed at 4:00 p.m., RN #4 documented Patient #8 had no signs or symptoms of distress or discomfort at that time, but in the next sentence, she documented Patient #8 was observed to grab her GJ (gastrostomy-jejunostomy) tube site several times and complained of pain when standing. The RN failed to document an accurate assessment of Patient #8's status as it was unclear whether Patient #8 was in pain or without pain. Review of a Ped Visit note completed on 10/28/21 for the 4:00 p.m. to 8:00 a.m. shift by RN #5, revealed RN #5 documented Patient #8 had abdominal pain with a pain level of five. RN #5 failed to provide the scale for this pain rating in her note and did not indicate what pain tool she used to determine Patient #8's pain level. RN #5 documented Patient #8 was holding her left side, was "very pale", heart rate of 150 beats per minute (bpm), and her abdomen appeared distended, but was soft and Patient #8 was without signs or symptoms of pain with palpation. RN #5 documented that Patient #8's PD catheter site was "red intact" and her GJ tube dressing was clean, dry and intact. RN #5 documented that Patient #8 was afebrile and free of signs or symptoms of infection. The RN failed to document an accurate assessment of Patient #8's status, as it was unclear if the patient had signs or symptoms of an infection or not. b. The agency failed to ensure Patient #8's clinical record contained an accurate and complete clinical visit note. Review of Ped visit p.m. (4:00 p.m. to 8:00 p.m.) notes dated 10/15/21 to 10/24/21, revealed RN #5 documented the same narrative note for ten nights in a row as follows, " 1600-0800 Patient tolerating her new formula well. Irregular heart sounds noted but good pulses and perfusion. VSSA [vital signs stable afebrile] PD[peritoneal dialysis] catheter site clean, dry, and intact. GT [gastrostomy tube] dressing clean, dry and intact Abdomen appears distended but is soft and child is without s/sx [sign/symptom] of pain with palpation. Eyes appear deconjugate at times. Patient running continuous enteral feed of formula mixture through j [jejunostomy] tube at 38ml/hr. Diaper dry at this time. Patient afebrile and free of s/sx of infection. GT cares and bath done prior to this RN's shift per report. Peritoneal dialysis running as ordered 2100 - 0500 Patient awoke several times coughing PD tubing and feed tubing kinked several times and patient had to be repositioned. Enteral feed running continuously via JT [jejunostomy tube] per orders. Nasal suction x 1 overnight for moderate thick cloudy secretions. Patient awake coughing several times overnight. 0600- Patient awake and alert. Diaper changed. Moderate UOP [urinary output] and medium soft BM [bowel movement] 0700- Patient awake and alert playing with toys in crib. 0800 - Patient sitting up in crib smiling and playing with toys Free of s/sx of distress or discomfort Dialysis finished this am and disconnected." RN #5's documentation failed to provide an accurate description of the cares provided during the shift. Further, RN #5 failed to identify within the body of the note, if Patient #8 had a g-tube, a j-tube or a gj-tube. Review of RN #5 notes for Patient #8 dated 9/19/21 to 11/6/21 revealed similar findings of the notes having very little variation in content. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that she tried to give a description of what happened during the shift at the beginning of her note. RN #5 stated her documentation was not perfect. c.The agency failed to ensure Patient #8's clinical record contained an accurate frequency of RN services to be provided. Review of the Plan of Care dated 9/19/21 to 11/17/21 revealed Employee #1 documented under the Caregiver Status, "RN/LPN up to 24 hours/day". Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatment, "RN/LPN 16 x day for 60 days and RN/LPN 8 x day for 60 days." and under Hospitalization/Emergency Room Visit Risk Interventions she documented "Establish emergency plan and instructions for 24 hour contact." It was unclear whether Patient #8 required 24 hour care or if she required less than 24 hour care as stated under the Caregiver Status section (up to 24 hours/day 7 days/week). Review of the clinical record dated 10/10/21 to 11/3/21 revealed the agency nurses were documenting one eight hour shift during the day from 8:00 a.m. to 4:00 p.m. and one 16 hour shift during the night from 4:00 p.m. to 8:00 a.m. totalling 24 hours of care every day. d. The agency failed to ensure Patient #8's clinical record contained accurate information on all supplies required for her peritoneal dialysis. Review of the POC dated 10/10/21 to 11/3/21 revealed Employee #1 documented under Genitourinary Interventions that Patient #8 was to receive daily PD with delivery system of continuous cycling peritoneal dialysis/ intermittent peritoneal dialysis, mode low fill, total dialysis volume 3400ml therapy time 11 hours, total fill 300 ml (33ml/kg/fill) last fill 100 ml, cycles 11 and final dextrose concentration 2%. Employee #1 failed to provide information on what solution bags were being used for the dialysis. e. The agency failed to ensure Patient #8's clinical record contained an accurate description of Patient #8's medications. Review of the POC dated 10/10/21 to 11/3/21 completed by Employee #1 revealed Patient #8 was to receive Levothyroxine (a thyroid medication) 0.100mg (1000 mcg) daily feeding tube. Review of "After Visit Summaries" dated 10/4/21 and 11/1/21 provided by the foster mother of the child (RN #5) to the agency, revealed Patient #8 Levothyroxine dosage as 100 mcg to be given once a day by g-tube by crushing the tab and mixing it with water. Review of the medication administration record (MAR) for Patient #8 revealed RN #5 documented providing 1000 mcg of Levothyroxine every day in October and 11/1/21 to 11/9/21. During an interview on 11/16/21 at 6:12 p.m., RN #14, who completes recertifications for Patient #8, reviewed Patient #8's October and November 2021 MAR and the POC for certification period 9/19/21 to 11/17/21 and stated the dosage listed of Levothyroxine as 1000 mcg is inaccurate. RN #14 confirmed that Patient #8 was prescribed 100 mcg. RN #14 stated the dosage of 100mcg was on Patient #8's Leothyroxine bottle but acknowledge the potential was there if a fill in nurse looked at the dosage on the MAR and POC, that Patient #8 could have accidentally been administered ten times the dosage of her ordered Levothyroxine. f. The agency failed to ensure Patient #8's clinical record contained an accurate list of the durable medical equipment Patient #8 was using and contained physician orders to use the equipment. Review of the POC for Patient #8 with certification period 9/19/21 to 11/17/21 lists her durable medical equipment as follows: "pump bags, pump, clamp, charger, IV pole, 60 ml [milliliter] cath tip syringe, 10 ml syringe, ½ inch hy-tape, formula, back pack, 2x2 split gauze, extension sets, back up gt [gastrostomy] button, 2 foley catheters, 2 gravity bags(for emergencies), additional 15mls of formula per feed required to prime tubing, oxygen, oxygen tubing, pulse oximeter, scale, peritoneal dialysis machine, crib, O2 [oxygen] concentrator, oxygen tubing, infant car seat, stroller, blood pressure cuff, O2 concentrator, oxygen tubing, infant car seat, stroller, blood pressure cuff, bath chair, feeding chair, swing, Zflow pillow, surgical mask and gowns." The agency failed to ensure the suction machine used daily with Patient #8 was listed on her POC. Further review of the Plan of Care stated under Respiratory Interventions: "assess respiratory status and report s/s [signs/symptoms] of respiratory infection; instruct caregiver on proper care of oxygen equipment and safety measures related to; report signs of respiratory distress/oxygen deprivation; perform SPO2 [oxygen saturation measurement] 4 x daily; Instruct/perform application of 0.25 liters of oxygen for oxygen saturation Review of visit notes for Patient #8 dated for the p.m. (4:00 p.m. to 8:00 p.m.) shift revealed that Patient #8 had been provided with nasal suctioning 16 times by RN #5. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that she used a suction machine to provide nasal suction to Patient #8 as needed, and Patient #8 had a suction machine since RN#5, her foster mother, had started caring for Patient #8. g. The agency failed to ensure Patient #8's clinical record contained physician orders obtained for changes made to Patient #8's medications. Review of Patient #8's POC for the certification period 9/19/21 through 11/17/21 revealed Patient #8 was to receive multiple medications which included: Captopril 1/mg/ml (milligram/milliliter) 0.3 (no units were provided on the POC) through g-tube or by mouth two times daily; Miralax oral powder for reconstitution 17gm/scoop (gram/scoop), 2.833 gm by mouth every other day as need; Retacrit 4000 units/ml preservative free injectable solution administer 920 units (0.23mls) subcutaneously weekly on Mondays; Calcitriol 1 mcg/ml (microgram/ml) oral liquid 0.5 mcg(0.5ml) administer into check by mouth daily; calcium carbonate 1250 mg/5ml (100 mg/ml elemental calcium) oral suspension 2.5 ml into bag 3 time daily by mouth; oxycodone 5 mg/5ml oral solution 0.5 mg (0.5ml) by mouth or through g-tube for breakthrough pain not controlled by acetaminophen every 6 hours as needed by mouth. However, Patient #8's medication profile showed she was to receive multiple medications which included: Captopril 1mg/ml 0.4 ml through her g-tube or by mouth two times daily; Miralax oral powder for reconstitution 17 gm/scoop 2 gms into feed bag one time daily; Retacrit 4000 units/ml preservative-free injectable solution administer 880 units (0.22mls) subcutaneously two times weekly; Calcitriol 1 mcg/ml oral liquid 1mcg (1ml) administer into cheek daily by mouth; Calcium Carbonate 1250 mg/5ml (100 mg/ml elemental calcium) oral suspension 7.5 ml into bag one time daily by mouth. Further review of Patient #8 medication profile showed Patient #8's oxycodone was discontinued on 10/19/21. There was no evidence orders had been obtained from the physician to make these medication changes. Clinical record review revealed no evidence the agency had contacted the physician to obtain a physician order for any of the medication changes for Patient #8. During an interview on 11/16/21 at 2:07 p.m., Patient #8's foster mother, (RN #5), stated when she received after visit instructions from the doctor for Patient #8, she would send these instructions to the agency and the other nurses caring for Patient #8 as she assumed all of these instructions were orders to be followed. 2. The clinical record for Patient #6 was reviewed on 11/16/21. The Plan of Care for the certification periods dated 8/31/21 to 10/29/21 and 10/30/21 to 12/28/21 revealed a start of care date of 3/4/21; diagnoses included necrotizing enterocolitis, postgastric surgery syndromes, dysphagia (swallowing difficulties), sepsis, and gastrostomy tube placement. Plan of Care orders included skilled nursing (SN) services sixteen times a day for 1 hour for 60 days total and SN services eight times per day for 1 hour for 60 days for total parenteral nutrition, medication administration, vitals, monitoring, and assessment, and CNA services up to seven times per day for one hour for 60 days for assistance with personal care and light housekeeping. a. The agency failed to ensure Patient #6's clinical record contained complete and accurate clinical notes. Specifically, the agency failed to ensure Patient #6 was weighed weekly on Monday and those weights were documented in the clinical record. Review of the Plan of Care dated 8/31/21 to 10/29/21 and 10/30/21 to 12/28/21 revealed orders for patient weights to be obtained weekly every Monday. Review of the Peds Visit Notes dated 8/31/21 to 11/9/21 revealed no evidence of patient weights documented on 9/6/21, 9/13/21, 9/27/21, 10/4/21, and 10/25/21. b. The agency failed to ensure Patient #6's clinical record contained complete and accurate clinical notes. Specifically, the agency failed to ensure the SN accurately documented Patient #6's tube feedings. Review of the Plan of Care dated 8/31/21 to 10/29/21 revealed orders for "G-tube feedings of Elecare 24 kcals 840 mls +30 mls of green bean puree +35 mls per hour over 24 hours. Increase formula every 2 days as tolerated with goal of 44 mls/hour." Review of the Peds visit AM note dated 9/7/21, RN #4 documented Patient #6's G-tube feedings were running at 43 milliliters per hour (ml/hr). Review of the Peds visit AM note dated 9/14/21, RN #4 documented Patient #6's G-tube feedings were running at 44 ml/hr. However, between 9/7/21 and 9/14/21 there was no evidence of documentation of the current G-tube rate to show when the feeding rate was increased and what rate it was currently running at. Review of the Peds visit PM note dated 9/6/21, RN #5 documented, "1600-0800 (4:00 p.m. to 8:00 a.m.) Slowly increasing feeds." There is no evidence of documentation of what the G-tube feedings were running at or what the rate was being increased to. RN #5 continued to document she was slowly increasing the G-tube feeding rate from 9/14/21 to 10/2/21, 18 days after Patient #6 reached their goal of 44 mls/hr. Further review showed RN #5 did not document what Patient #6's G-tube feeding rate was or what it was being increased to. Review of the Peds visit PM note dated 10/8/21 revealed RN #5 documented Patient #6 was receiving G-tube feedings at the ordered rate of 46 mls/hr, however, there was no evidence of a physician order to increase the rate to 46 mls/hr until the new Plan of Care was established on 10/30/21. Review of the Plan of Care dated 10/30/21 to 12/28/21 revealed orders for, "G-tube feedings of Elecare 24 kcals 1104 mls +10mls of green bean purees @ 46 mls per hour over 24 hours." Review of the Peds visit AM note dated 11/1/21 revealed RN #4 documented, "GT (G-tube) feed running continuously at 47 mL/hr." However, there was no evidence of a physician order for a G-tube feeding rate of 47 mls/hr on the Plan of Care. RN #4 documented Patient #6 was receiving a G-tube feeding rate of 47 mls/hr from 11/1/21 to 11/4/21. c. The agency failed to ensure Patient #6's clinical record contained complete and accurate clinical notes. Specifically, the agency failed to ensure Patient #6's clinical record contained physician orders for saline, heparin, and Vancomycin flushes to be provided with Patient #6's central venous catheter (CVC). Review of the Plan of care dated 8/31/21 to 10/29/21 revealed Patient #6 had a Broviac CVC for the administration of total parenteral (intravenously infused) nutrition (TPN). Further review of the Plan of Care revealed the following CVC care orders: "Dressing Change weekly 1.Wash hands thoroughly with soap and water 2. Open packages 3. Put on gloves 4. Remove the old dressing 5. Check site for infection (i.e. redness, swelling or drainage) 6. Remove dirty gloves 7. Wash hands again or sanitize . Put on new, clean gloves. 8. Clean the exit site with chlorhexidine swabstick using a repeated back and forth motion for 30 seconds. Make sure to clean all parts of the catheter that will be under the dressing. 9. Allow to air dry for 15-30 seconds. Do not blow or fan the skin. 10. If desired, apply skin protectant to the outer edge of skin. Do not apply directly on the catheter. 11. Apply the clear dressing and bio patch" Review of the medication on the Plan of Care dated 8/31/21 to 10/29/21 revealed an order for, "ALTEPLASE (1 mg/ml) 0.33 mg via central line to clear withdrawal occlusion in the home One time and as needed in the future for withdrawal occlusion intravenous (IV)." Review of the Peds visit PM note dated 9/2/21 revealed RN #5 documented, "CVC flushed with saline and heparin/vanco [antibiotic] per orders," however, there were no orders on the Plan of Care for a saline flush, heparin flush or vancomycin instillation for the CVC. Further review of the Peds visit PM notes and the Peds visit AM notes dated 9/2/21 to 11/3/21 revealed staff RN's continued to chart intermittently they were flushing the CVC with saline, heparin, and vancomycin per orders, however, no evidence of these flushes was found on the Plan of Care or in physician's orders. During an interview on 11/16/21, RN #5 stated she received orders in the form of an after hours summary, provided by the physician during physician appointments and these were conveyed to the rest of the agency staff involved in Patient #6's care primarily by email and by a social networking application (Whatsapp). She further stated that this was how all of the PDN SNs got their orders and forwarded them on to other pertinent staff members. During an interview on 11/17/21, the agency administrator stated, in between certification periods, physician orders were not generated in the agency electronic medical record (EMR). She stated the SNs received a care summary after physician appointments but they were not placed into the EMR as new physician orders and sent to the physician for approval and signature. During further interviews with the agency administrator, the administrator stated agency staff were supposed to follow the Plan of Care as ordered by the physician, and the agency thought they had been doing that by following the after care summary given to the staff by the physician. She further stated they did not realize the after care summaries were not physician orders, only a summary of what the physician appointment entailed, and she stated going forward the SNs would send the summary to the office to be written as verbal orders from the physician. 3. The clinical record for Patient #7 was reviewed on 11/8/21. The POC for the certification period dated 10/16/21 to 12/14/21 revealed a start of care date of 10/16/21; diagnoses included hypoxic ischemic encephalopathy, anoxic brain damage, cortical blindness, gastrostomy status, congenital hypertonia, and lack of expected normal physiological development in childhood, disorders of muscle, elevation of levels of lactic acid dehydrogenase, feeding difficulties, urinary incontinence, full incontinence of feces, sedative, hypnotic, anxiolytic dependence with withdrawal, need for assistance with personal care, personal history of urinary calculi, and global developmental delays POC orders included RN visits up to 24 hours daily for gastrostomy tube (g-tube) feedings, medication administration, vitals signs, monitoring and assessment, continuous line of sight supervision,nursing interventions during a seizure and CNA visits up to 6 hours for assistance with personal care, light housekeeping and continuous line of sight monitoring. a. The agency failed to ensure Patient #7's clinical record contained an accurate description of Patient #7's seizures and care provided during the seizure. Review of Ped visit p.m. (4:00 p.m. to 8:00 a.m.) notes dated 10/16/21 through 11/2/21 revealed RN #5 documented Patient #7 had "Seizures intermittent." RN #5 failed to document the length of each seizure, how many seizures total he had during the shift, the interventions RN #5 used to protect Patient #7 during the seizures, if she had to administer Patient #7's rescue seizure medication (Midazolam to be given for seizures lasting greater than 5 minutes) , and if she provide Patient #7 with line of sight supervision during the seizure as ordered on his POC. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that Patient #7 had one or more seizures a day and she had never had to administer Patient #7 rescue seizure medication as his seizures did not last that long. b. The agency failed to ensure Patient #7's clinical record contained an accurate frequency of RN services to be provided. Review of the POC dated 10/16/21 to 12/14/21 revealed Employee #1 documented under the Caregiver Status, "RN/LPN up to 24 hours/day 7 days/week". Further review of the POC revealed Employee #1 documented under Orders for Discipline and Treatment, "RN/LPN 16 x day for 60 days and RN/LPN 8 x day for 60 days." Under Hospitalization/Emergency Room Visit Risk Interventions she documented "Establish emergency plan and instructions for 24 hour contact." It was unclear whether Patient #7 required 24 hour care or if she required less than 24 hour care as stated under the Caregiver Status section (up to 24 hours/day 7 days/week). Review of the clinical record dated 10/16/21 to 11/10/21 revealed the agency nurses documented one eight hour shift during the day from 8:00 a.m. to 4:00 p.m. and one 16 hour shift during the night from 4:00 p.m. to 8:00 a.m. every day, totalling 24 hours of care every day. c. The agency failed to ensure that Patient #7's clinical record contained all pertinent diagnoses. Review of visit notes for Patient #7 dated 10/16/21 to 10/30/21 revealed Patient #7 experienced intermittent seizures 14 times during the p.m. (4:00 p.m. to 8:00 a.m.) shift as documented by RN #5. The agency failed to ensure Patient #7's POC included a seizure disorder diagnosis. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that Patient #7 had one or more seizures a day and she had never had to administer Patient #7's rescue seizure medication (Midazolam to be given for seizures lasting greater than 5 minutes) as his seizures did not last that long. 4. The clinical record for Patient #10 was reviewed on 11/15/21. The POC for the certification periods 9/5/21 through 11/3/21 and 11/4/21 through 1/2/22 revealed a start of care date of 1/8/21; diagnoses included Seizures, gastrostomy status, esophageal reflux, atrial septal defect, patent ductus arteriosus, protein-calorie malnutrition, chronic obstructive pulmonary disease, hypoxemia, developmental delays, anisometropia and eczema. POC orders included RN up to 24 times a day for g-tube feedings, medication administration, vital signs, monitoring, assessment, and continuous line of sight supervision and nursing interventions during seizure activity and CNA up to six times a day for assistance with personal care, light housekeeping and continuous line of sight monitoring. a. The agency failed to ensure Patient #10's clinical record contained complete and accurate clinical notes. Review of Peds visit p.m. (4:00 p.m. to 8:00 a.m.) notes for Patient #10 dated 9/15/21 to 10/15/21, completed by RN #5, revealed RN #5 documented 41 nights in a row the same narrative in her note as follows: "16:00-0800 Lung sounds clear and equal GT [gastrostomy tube] cares and diaper changed prior to this RN's shift per report. Continuous overnight GT feed running per orders. 2100-0600- Patient sleeping in crib free of s/sx [signs/symptoms] of distress or discomfort. Continuous GT feed running per orders. Patient repositioned self several times overnight. Patient awake several times overnight and had to be consoled by RN to fall back asleep. 0600 Overnight GT feed complete Flushed with water per orders. Patient awake and alert, smiling and playing with toys in crib Diaper changed for moderate UOP [urinary output] and medium soft BM [bowel movement]. GT site clean, dry, intact and open to air. 0700 Patient supervised playing with siblings. 0800 Patient awake and alert playing with toys in crib. Diaper changed for moderate UOP and medium soft BM. No s/sx of distress or discomfort noted at this time." RN #5's documentation failed to provide an accurate picture of cares provided and Patient #10's medical status during the shift. During an interview on 11/16/21 at 2:07 p.m., RN #5 stated that she tries to give a description of what happened during the shift at the beginning of her note. RN #5 stated her documentation is not perfect. b. The agency failed to ensure Patient #10's clinical record contained an accurate frequency of RN services to be provided. Review of the POC dated 9/5/21 to 11/3/21 and 11/4/21 to 1/2/22 revealed Employee #1 documented under the Caregiver Status, "RN up to 24 hours/day". Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatment, "RN up to 16 hours a day for 60 days and RN up to 8 hours a day for 60 days." and under Hospitalization/Emergency Room Visit Interventions she documented "Establish emergency plan and instructions for 24 hour contact." However, it was unclear whether Patient #10 required 24 hour care or if she required less care than 24 hour care as stated under the Caregiver Status section (up to 24 hours/day 7 days/week) Review of the ped visit notes dated 9/5/21 to 11/13/21, revealed the agency nurses were documenting one eight hour shift during the day from 8:00 a.m. to 4:00 p.m. and one 16 hour shift during the night from 4:00 p.m. to 8:00 a.m. totalling 24 hours of care every day. However, from the POC it is unclear whether Patient #8 was supposed to receive 24 hour care or whether the patient would receive 24 hour care only when it was necessary. 5. The clinical record for Pediatric Patient #14 was reviewed on 11/5/21. The Plan of Care for the certification period dated 10/4/21 to 12/2/21 revealed a start of care date of 10/9/20; diagnoses included pulmonary valve atresia, isomerism of atrial appendages, asplenia and gastrostomy status. Plan of Care orders included RN visits up to 24 hours per day for g-tube feedings and associated care, chest physiotherapy (CPT) twice daily, medication administration, vital signs, monitoring and assessment and CNA visits up to five hours daily for nine weeks for personal care, light housekeeping and continuous line of sight monitoring. a. The agency failed to ensure Patient #14's clinical record contained complete and accurate clinical notes. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/10/21 through 10/17/21 completed by RN #7 revealed RN #7 had documented the exact same activities at the same times every night. Specifically: "1600-0800 1600-Report received from MOC [mother of child] and discharge paperwork from hospital was reviewed. Pt [patient] stable at transfer of care. Assessment completed all findings. Pt appears to be comfortable. No WPB [wide pulse banking] noted. Pt vitals within ordered limits. Diminished breathe sounds noted in LLL [left lower lung]. TF [tube feeding] running at 80ml/hr. 1/2 LPM [liters per minute] O2 given via NC [nasal cannula]. 1800-Pt diaper changed. Skin and GT [g-tube] stoma is intact and free from s/sx [signs/symptoms] of infection. 2100-Oral and INH [inhaled] Meds given (see MAR). Pt tolerated well. 2130-Pt transferred to bed. Cont [continuous] pulse ox monitoring started. Overnight GT feeding started via pump at 80ml/hr. Diaper changed. Pt remains in bed with all rails up. 2200-Pt remains in bed and appears to be sleeping. Pt is stable on 1/2 LPM O2 with no increased work of breathing noted. 2300-TF running at 80ml/hr without issue. PDN added formula to feeding bag. Pt stable on 1/2 LPM with no increased work of breathing noted. Pt appears to be asleep. 0100-Pulse ox probe changed to opposite foot. TF running without issue. PDN added formula to feeding bag. Pt stable on 1/2 LPM O2 with no increased work of breathing noted. Pt appears to be asleep. 0200-Pt stable on 1/2 LPM O2. Pt appears to be sleeping. 0400-Pulse ox probe changed to opposite foot. Pt stable on 1/2 LPM O2 with no increased work of breathing noted. Pt appears to be asleep. 0600-Pt stable on 1/2 LPM O2. Pt appears to be sleeping. 0800-Care handed off to oncoming nurse. Pt stable at time of handoff." Further review of SN overnight shifts completed by RN #7 for the period 9/16/21 through 11/5/21 revealed similar findings of RN #7 documenting the exact same activities every shift. b. The agency failed to ensure Patient #14's clinical record contained physician orders for changes in Patient #14's medication. Review of the medications listed on the POC showed Furosemide 10 mg/ml oral liquid, give 1.5 mls via g-tube three times daily. Review of Patient #14's medication profile showed Furosemide 1.5 mls via g-tube three times daily had been discontinued on 11/14/21. There was no evidence an order had been obtained from the physician to make this change. Clinical record review revealed no evidence the agency had contacted the physician to obtain a physician's order to discontinue Patient #14's Furosemide. During an interview on 11/9/21 at 8:53 a.m., the DON stated medication changes were tracked on the patient's medication profile andMAR. The DON stated nursing staff would administer medications according to the MAR. The DON further stated any changes in medications were provided by the patient's mothers according to physician appointments aftercare instructions and no physician orders had been obtained for the medication changes. 6. The clinical record for Patient #12 was reviewed on 11/16/2021. The POC for the certification period dated 09/05/2021 to 11/03/2021 revealed a start of care date of 01/08/2021; diagnoses included feeding difficulties, sleep apnea, gastrostomy, hypothyroidism, supplemental oxygen dependency, developmental disorder, urinary and fecal incontinence. POC orders included RN visits up to 24 hours daily for gastrostomy tube (GT) feedings, medication administration, vital signs, monitoring, assessment, supervision at all times during ambulation and seizure activity, as well as CNA visits up to six hours daily, for personal care, light housekeeping and continuous line of sight monitoring. a) The agency failed to ensure that Patient #12's clinical record contained all pertinent diagnoses. Specifically, The agency failed to ensure Patient #12's POC included a seizure disorder diagnosis. Review of visit notes dated from 10/04/21 to 11/03/21 completed by RN #5 revealed Patient #12 experienced seizures, which were almost daily. In addition, she was also on prescribed medications for her seizures that included, Vimpat, 50mg two times daily through the GT and Midazolam 5 mg per 1ml, 2mls into the patients nares, as needed for seizures lasting longer than 5 minutes. During an interview on 11/04/21 at 9:00 AM, RN #5 stated that Patient #12 had frequent seizure activity and was often home from school as a result. 7. The clinical record for Pediatric Patient #13 was reviewed on 11/5/21. The Plan of Care for the certification period dated 10/13/21 to 12/11/21 revealed a start of care date of 12/17/20; diagnoses included disorders of lung, chronic respiratory failure, myotonic muscular dystrophy, dysphagia, dependence on ventilator, tracheostomy status and gastrostomy status. Plan of Care orders included RN visits 24 hours daily for ventilator care during naps and overnight, tracheostomy care, CPT three times daily, g-tube feedings and associated care, vital signs, monitoring and assessment and CNA visits up to six and half hours daily for personal care, light housekeeping and continuous line of sight monitoring. a. The agency failed to ensure Patient #13's clinical record contained complete and accurate clinical notes. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/14/21 through 10/20/21 completed by RN #7 revealed RN #7 had documented the exact same activities at the same times every night. Specifically: "1600-0800 1600-Pt on floor playing with toys. Pt appears stable at time of hand off. Hand off completed with outgoing nurse. 1700-Pt diaper changed and perineal care provided. 1800-Pt transferred to wheelchair. Neb [Nebulizer] treatments (See MAR) and CPT completed. Pt suctioned after treatment. Pt tolerated well. Pt playing in wheelchair. PDN nurse monitoring and reconnecting vent circuit frequently during this time due to Pts movement and Pt pulling circuit apart. 1900-Med given (see MAR) Pt tolerated well. Pt transferred to bed. Pt diaper changed and perineal care given. Skin is CDI [cool, dry, intact]. No redness noted. Ventilation and humidification started in bed with 21pm O2 bled through vent. Cont pulse ox monitoring started. Overnight feeds started via pump at 82ml/hr. Pt laying on back in bed. Bed is in lowest position and all rails are up. Pt remains in bed. 2115-Pt stable. Pt appears to be sleeping. Vitals WNL [within normal limits]. 2330-Pt stable. Vitals stable. Feed running without issue. 0100-Vitals stable. Pt appears to be asleep. Lung sounds clear. 0300-Vitals stable. Feed running and vitals are stable. 0600-Feed ended. Tubing disconnected. 0730-Pt awake in bed. Pt diaper changed. Urine present. Pt suctioned via trach. Med [medium] thick white secretions present. 0800-Handoff completed with oncoming nurse. Pt stable at time of handoff." Further review of SN overnight shifts completed by RN #7 for the period 10/13/21 through 11/5/21 revealed similar findings of RN #7 documenting the exact same activities every shift. 8. The clinical record for Pediatric Patient #16 was reviewed on 11/8/21. The Plan of Care for the certification period dated 10/10/21 to 12/8/21 revealed a start of care date of 12/14/20; diagnoses included bronchopulmonary dysplasia, congenital malformations of respiratory system, chronic respiratory failure, dependence on ventilator, trach status and gastrostomy status. Plan of Care orders included RN to provide around the clock care to include medication administration, g-tube feedings and associated care, CPT three times daily, maintain ventilator during overnight only, trach care, suctioning twice daily, monitoring and assessment. a. The agency failed to ensure Patient #16's clinical record contained complete and accurate clinical notes. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/10/21 through 10/16/21 completed by RN #7 revealed RN #7 had documented the exact same activities at the same times every night. Specifically: "1600-0800 1600-Pt on floor playing with toys. Pt appears stable at time of hand off. Hand off completed with outgoing nurse. 1700-Pt diaper changed and perineal care provided. Urine present. Pt transferred to wheelchair. Pt suctioned. Neb treatments (See MAR) and CPT completed. Pt tolerated well. Pt suctioned after treatment. 1800-Pt playing in wheelchair. 1900-Med given (See MAR) Pt tolerated well. Pt transferred to bed. Pt diaper changed and perineal care given. Split gauze removed at trach site. Skin is CDI. No redness noted. Cont pulse ox monitoring started. Pt connected to ventilation and humidification. Overnight feed started. Pt laying on back in bed. Bed is in lowest position and all rails are up. Pt remains in bed. 2100-Pt stable. Pt appears to be sleeping. Vitals WNL. 2300-Pt stable. Pt appears to be asleep. Lung sounds clear. 0300-Vitals stable. Pt on right side. Pt appears to remain asleep. Feed running and vitals are stable. 0500-TF ended and disconnected. Pt tolerated well. 0600-Pt appears to be asleep. Pt stable. No s/so of pain or distress. 0800-Handoff completed with oncoming nurse. Pt stable at time of handoff." Further review of SN overnight shifts completed by RN #7 for the period 10/10/21 through 11/5/21 revealed similar findings of RN #7 documenting the exact same activities every shift. b. The agency failed to ensure Patient #16's clinical record contained the frequency and duration of RN visits. Review of the POC for the period dated 10/10 to 12/8/21 revealed no frequency or duration of visits to be performed by the RN, however, the RN was ordered to provide the specific interventions of around the clock care to include medication administration, g-tube feedings and associated care, CPT three times daily, maintain ventilator during overnight only, trach care, suctioning twice daily, monitoring and assessment. 9. The clinical record for Pediatric Patient #17 was reviewed on 11/9/21. The Plan of Care for the certification period dated 10/13/21 to 12/11/21 revealed a start of care date of 12/17/20; diagnoses included anoxic brain damage, hypoxic ischemic encephalopathy, quadriplegia, scoliosis, contracture of unspecified joint and gastrostomy status. Plan of Care orders included RN visits 24 hours per day for g-tube feedings, medication administration, vital signs, monitoring and assessment and CNA visits up to seven hours daily for personal care, light housekeeping and continuous line of sight monitoring. a. The agency failed to ensure Patient #17's clinical record contained complete and accurate clinical notes. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/13/21 through 10/18/21 completed by RN #7 revealed RN #7 had documented the exact same activities at the same times every night. Specifically: "1600-0800 1600-Pt laying in bed on left side. Pt appears stable at handoff. Handoff completed with outgoing nurse. 1700-Assessment completed. All finding WNL per orders and Pt's baseline. Started feed via pump at 500ml/hr. 1730-feed complete. Pt tolerated well. 1800-Pt repositioned. 1900-Pt repositioned. Brief changed. Urine present. 2000-Meds given (see MAR). Pt tolerated well. 2200-Pt transferred to therapy bed. Pt brief changed. Med BM [bowel movement] present. Perineal care provided. 2230-Pt transferred to bed. Overnight feed started. Continuous pulse ox monitoring started. All rails on bed up. Pt remains in bed. 0000-Pt repositioned. Pt appears to be asleep. Pt is stable. 0200-Pt repositioned. Pulse ox probe place on different finger. Pt tolerated well 0400-Pt repositioned Pt appears to be asleep. Pt is stable. Pt tolerated well. 0600-Pt repositioned Pulse ox probe placed on different finger. Pt tolerated well. Overnight feed complete and disconnected. 0700-Pt awake in bed. Meds given (see MAR). Pt tolerated well. 0800-Hand off completed with oncoming nurse. Pt is stable at time of handoff." Further review of SN overnight shifts completed by RN #7 for the period 10/13/21 through 11/5/21 revealed similar findings of RN #7 documenting the exact same activities every shift. 10. The clinical record for Pediatric Patient #18 was reviewed on 11/3/21. The Plan of Care for the certification period dated 9/16/21 to 11/12/21 revealed a start of care date of 9/16/21; diagnoses included failure to thrive, non-traumatic intracerebral hemorrhage, convulsions and gastrostomy status. Plan of Care orders included RN visits up to 24 hours a day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment. a. The agency failed to ensure Patient #18's clinical record contained complete and accurate clinical notes. Review of overnight (4:00p.m. through 8:00 a.m.) SN visits from 10/10/21 through 10/16/21 completed by RN #7 revealed RN #7 had documented the exact same activities at the same times every night. Specifically: "1600-0800 1600-Pt in bed on back watching iPad at time of handoff. Pt stable. 1800-Meds given (see MAR) Pt tolerated well. Pt cont feed started at 60ml/hr. Assessment completed. All findings WNL. Perineal care provided and diaper changed. Pt in bed on back all rails up. 2000-Pt stable and repositioned. TF continues to run w/o issue. Pt appears to be asleep. 2200-Pt repositioned. Pt appears to remain asleep. TF running. 0000-Pt stable and appears to be sleeping. TF running w/o issue. Pt repositioned 0200-TF running. Pt repositioned. 0400-TF running. Pt repositioned. 0600-TF stopped. Pt awake in bed. Pt stable and smiling. 0800-Pt stable. No s/sx of pain present. Care handed off to oncoming nurse." Further review of SN overnight shifts completed by RN #7 for the period 9/16/21 through 11/5/21 revealed similar findings of RN #7 documenting the exact same activities every shift. During an interview on 11/4/21 at 9:00 a.m., RN #7 stated her documentation of each shift is the same as the patient's residing in the home have a routine and it rarely changed. RN #7 further stated that her documentation could be better and would work on it. b. The agency failed to ensure Patient #18's clinical record included documentation of advanced directives, caregiver and psychosocial statuses. Further review of the POC for the period dated 9/16 to 11/14/21 revealed the advanced directives, caregiver and psychosocial status sections were documented as "there is no data for this section." During an interview on 11/17/21 at 10:42 a.m., the DON stated plans of care had not been accurately documented to include all the pertinent information required. The DON further stated she had taken a step back in her responsibilities and the quality assurance of the plans of care had not occurred. c. The agency failed to ensure Patient #18's clinical record contained physician orders for a change in Patient 18's medication. Review of medications listed on the POC showed Pediatric Patient #18 was to receive Baclofen 5 milligrams (mg)/milliliter (ml) oral suspension, given 1.5 mls (7.5 mg) three times daily via j-tube. Review of Patient #18's medication profile showed he was to receive a Baclofen 10 mg oral tablet to be crushed and given one tablet via j-tube three times daily. Further review showed the 7.5 mg Baclofen had been discontinued on 11/14/21. There was no evidence an order had been obtained from the physician to make this change to Patient #18's Baclofen medication. Clinical record review revealed no evidence the agency had contacted the physician to obtain a physician's order to increase Patient #18's Baclofen from 7.5 mg three times daily to 10 mg three times daily. 11. The clinical record for Patient #1 was reviewed on 11/1/21. The Plan of Care for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnoses included spastic quadriplegic cerebral palsy, unspecified convulsions, and obstructive sleep apnea. Plan of Care orders included skilled nursing (SN) services up to sixteen hours per day and SN services up to eight hours per day for a total of up to 24 hours per day for gastrostomy tube feedings, medication administration, monitoring, vital signs (VS), and assessments, and certified nurse aide (CNA) services up to five hours per day for assistance with personal cares and light housekeeping. a. The agency failed to ensure Patient #1's clinical record contained complete and accurate clinical notes. Review of the Plan of Care dated 10/22/21 to 12/20/21, revealed Employee #1 documented under Caregiver Status, "RN/LPN up to 24 hours/day 7 days/wk." Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatments, "RN/LPN up to 16 hours per day and RN/LPN up to 8 hours per day," and under Hospitalization/Emergency Room Visit Risk Interventions she documented, "Establish emergency plan and instructions for 24 hour contact." However, it was unclear whether Patient #1 required 24 hour care or if they required less than 24 hours care. Review of the Plan of Care dated 10/22/21 to 12/20/21 revealed orders for, "Lidocaine Prilocaine 2.5-2.5% Apply small amount over intrathecal pump site Monthly 1 hour prior to pump refill Topical." However there was no evidence in Patient #11's record that the patient had an intrathecal pump. b. The agency failed to ensure Patient #1's clinical record covered all pertinent treatments and medications. Review of the Plan of Care dated 10/22/21 revealed an order for, "Ibuprofen 100mg/5 ml oral suspension. Give 20 mls (400mg) through g-tube for fever/pain Every 6 hours as needed." However, further review revealed no evidence of parameters for what temperature or pain levels the Ibuprofen is to be given at. Review of the POC dated 10/22/21 revealed orders for, "Give 1065 ml Complete Pediatric Reduced Calorie formula at rate approximately 100 ml/hr overnight. SN to provide daytime enteral feedings consisting [of] Complete Pediatric Reduced calorie formula 125 ml formula mixed with 150 ml water (275 ml total volume) at 8 am, 1200, and 4 pm." However, there were no parameters for checking for residual feedings to ensure the patient was digesting all of their feeding appropriately, and there were no parameters to hold or reduce feedings if the patient showed signs of not tolerating the feedings. Review of the medication list for the time period dated 10/22/21 to 11/1/21 revealed orders for, "Lidocaine Prilocaine 2.5-2.5% Apply small amount over intrathecal pump site monthly 1 hour prior to pump refill Topical," however there is no evidence in Patient #1's record that the patient had an intrathecal pump. During an interview on 11/17/21 at 10:42 a.m., the administrator stated the agency did not have a formal quality assurance (QA) program to catch inaccurate documentation on the POC or in the staff's documentation. She stated any mistakes on the medication administration record (MAR) or the POC should have been reported to the agency to be corrected. She further stated going forward the agency would have a QA nurse to review all of the POCs and staff documentation for errors and accuracy. 12. The clinical record for Patient #2 was reviewed on 11/3/21. The Plan of Care for the certification period dated 10/10/21 to 12/8/21 revealed a start of care date of 6/17/20; diagnosis included spastic quadriplegic cerebral palsy, disorders of the lung, encephaolpathy, epilepsy, hypoxemia, and feeding difficulties. Plan of care orders included SN services up to sixteen hours per day for one hour for nine weeks and up to eight hours per day for one hour for nine weeks for tracheostomy and ventilator care, gastric tube (GT) feedings, vital signs, monitoring, and assessments, and CNA services up to seven times a day for nine weeks to assist with personal care and light housekeeping. a. The agency failed to ensure Patient #2's clinical record contained complete and accurate clinical notes. Review of the Plan of Care dated 10/10/21 to 12/8/21 revealed Employee #1 documented under Caregiver Status, "RN/LPN up to 24 hours/day 7 days/wk." Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatments, "RN up to 16 x day x 9 weeks, 1hr duration and RN up to 8 x day x 9 weeks, 1hr duration," and under Hospitalization/Emergency Room Visit Risk Interventions she documented, "Establish emergency plan and instructions for 24 hour contact." However, it is unclear whether Patient #2 requires 24 hour care or if they require less than 24 hour care. Review of the ped visit notes dated 10/10/21 to 11/3/21 revealed the agency nurses were documenting one eight hour shift during the day from 8:00 a.m. to 4:00 p.m. and one 16 hour shift during the night from 4:00 p.m. to 8:00 a.m. totalling 24 hours of care every day. However, from the Plan of Care it is unclear whether the patient was supposed to receive 24 hour care or whether the patient would receive 24 hour care only when it was necessary. 13. The clinical record for Patient #3 was reviewed on 11/2/21. The Plan of Care for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnosis included post traumatic seizures, hemiplegia (paralysis of one side of the body), and a gastrostomy tube (G-tube). Plan of care orders included SN services up to 24 hours a day for 60 days for g-tube feedings, medication administration, vital signs, monitoring, and assessments, and CNA services up to six hours a day for 60 days for assistance with personal care and light housekeeping. a. The agency failed to ensure Patient #3's clinical record contained complete and accurate clinical notes. Review of the Plan of Care dated 10/22/21 to 12/20/21 revealed Employee #1 documented under Caregiver Status, "RN/LPN up to 24 hours/day 7 days/wk." Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatments, "RN/LPN up to 24 hours per day x 60 days," and under Hospitalization/Emergency Room Visit Risk Interventions she documented, "Establish emergency plan and instructions for 24 hour contact." However, it was unclear whether Patient #3 requires 24 hour care or if they require less care. 14. The clinical record for Patient #4 was reviewed on 11/8/21. The Plan of Care for the certification period dated 10/22/21 to 12/20/21 revealed a start of care date of 10/22/21; diagnosis included intracranial hemorrhage (bleeding in the brain), gastrostomy tube, autism, and developmental delays of speech and language. Plan of Care orders included SN services up to 24 hours per day for 60 days for g-tube feedings, medication administration, vital signs, monitoring, and assessments, and CNA services up to five hours per day seven days a week for assistance with personal care and light housekeeping. a. The agency failed to ensure Patient #4's clinical record contained complete and accurate clinical notes. Review of the Plan of Care dated 10/22/21 to 12/20/21 revealed Employee #1 documented under Caregiver Status, "RN/LPN up to 24 hours/day 7 days/wk." Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatments, "RN/LPN up to 24 hours x day for 60 days," and under Hospitalization/Emergency Room Visit Risk Interventions she documented, "Establish emergency plan and instructions for 24 hour contact." However, it was unclear whether Patient #4 requires 24 hour care or if they require less care. 15. The clinical record for Patient #5 was reviewed on 11/8/21. The Plan of Care for the certification periods dated 9/1/21 to 10/30/21 and 10/31/21 to 12/29/21 revealed a start of care date of 1/4/21; diagnosis included intestinal obstruction, gastrostomy tube, autism, attention-deficit hyperactivity disorder (ADHD), stenosis and atresia (narrowing) of the small intestine, and diarrhea. Plan of Care orders included SN services up to 24 hours per day for 60 days for g-tube feedings, medication administration, vital signs, monitoring, and assessments, and CNA services up to five hours per day seven days a week for assistance with personal care and light housekeeping. a. The agency failed to ensure Patient #5's clinical record contained complete and accurate clinical notes. Review of the Plan of Care dated 10/22/21 to 12/20/21 revealed Employee #1 documented under Caregiver Status, "RN/LPN up to 24 hours/day 7 days/wk." Further review of the Plan of Care revealed Employee #1 documented under Orders for Discipline and Treatments, "RN/LPN up to 24 hours x day for 60 days," and under Hospitalization/Emergency Room Visit Risk Interventions she documented, "Establish emergency plan and instructions for 24 hour contact." However, it was unclear whether Patient #5 requires 24 hour care or if they require less care. During an interview on 11/2/21 at 3:00 p.m., the administrator stated the agency had trouble with their frequencies in the past and it was decided the best way to cover the care the patient's needed was to write their frequencies as up to 24 hours of care for each private duty nursing (PDN) patient. She further stated that all of the PDN patients required 24 hour care. 16. The clinical record for Patient #15 was reviewed on 11/8/21. The POC for the certification period dated 9/24 to 11/22/21 revealed a start of care date of 7/31/20; diagnoses included spastic quadriplegic cerebral palsy, epilepsy, neuromuscular scoliosis, chronic respiratory failure and gastrostomy status. POC orders included RN visits up to 24 hours per day for g-tube feedings and associated care, medication administration, vital signs, monitoring and assessment and CNA visits up to six hours daily for personal care, light housekeeping and continuous line of sight monitoring. a) The agency failed to ensure Patient #15's clinical record included documentation of caregiver and psychosocial statuses. Further review of the POC for the period dated 9/24 to 11/22/21 revealed the caregiver and psychosocial status sections were documented as "there is no data for this section." 17. The clinical record for Patient #9 was reviewed on 11/03/21. The POC for the certification period dated 10/16/21 to 12/14/21 revealed a start of care date of 10/16/21; diagnoses included chronic respiratory failure (a condition that makes it difficult to breathe or get enough oxygen into the blood), dependence on a respirator ventilator (a machine that moves air in and out of your lungs), tracheostomy (an opening surgically created through the neck to allow direct access to the respirator breathing tube), epilepsy (a brain disorder that causes recurrent seizures), Ventriculoperitoneal Shunt (a surgically inserted drain used to drain excess fluid from the brain), gastrostomy (a surgically inserted tube into the abdominal wall used for feeding) and hearing loss. POC orders included RN visits up to 24 hours daily for tracheostomy care, gastrostomy tube (gt) feedings, vital signs, monitoring, and assessment and CNA visits up to seven hours daily for personal care, light housekeeping and continuous line of sight monitoring. a) The agency failed to ensure Patient #9's clinical record contained physician orders for antibiotics Patient #9 was administered by agency RNs. Review of the ‘Peds Visit AM’ note completed by RN # 4 on 11/02/21 showed the RN noted Patient #9 had an increase in tracheal secretions from the patient's baseline. Review of the ‘Peds Visit PM’ note completed by RN #5 on 11/02/21, also showed RN #5 had contacted the patient’s pulmonologist to report Patient #9 had to be suctioned through the tracheostomy more frequently, every 1 to 2 hours, for thick yellow secretions. RN #5 also noted she had received orders to start antibiotics. Further review of the patient’s medication administration record for the month of November 2021 showed Patient #9 was receiving Amoxicillin 400 mg per 5ml and to give 5.5ml through the GT three times a day for 7 days. However, there was no evidence the agency had ever obtained an order for the Amoxicillin medication that was added to the medication administration record.