Every finding on record at Maxim Healthcare Services

An unannounced complaint survey (Complaint #2026002503) was conducted from 3/2/26 to 3/6/26 at Maxim Healthcare Services. During the investigation of Complaint #2026002503, Immediate Jeopardy was identified on 03/05/26 for Code of Federal Regulations (CFR) 42, Part 484.22, Condition of Participation for Home Health Agencies. Conditions of Participation were found out of compliance at 484.60, Care Planning, Coordination, Quality of Care (Tag G570) and 484.105, Organization and Administration of Services (Tag G940). The Home Health Agency was notified of the Immediate Jeopardy on 3/5/26 at 1:07pm. The Immediate Jeopardy templates were provided to the Administrator on 3/5/26 at 2:20pm. Based on interviews, and record reviews, it was determined that the Home Health Agency (HHA) administration failed to ensure quality of care and services furnished in accordance with accepted standards of practice for one (Patient #1) of six sampled patients reviewed, specifically related to Patient #1 not receiving physician ordered medications for 47 days out of 47 days, starting 12/21/2025 to 02/04/2026 Patient #1's physician wasn't notified and the HHA administrative staff weren't notified about Patient #1 missing the physician ordered medications. Patient #1 had a start of care date of 07/28/2017 and was a 12-years-old patient. The patient was non-ambulatory and had diagnoses that included Cerebral Palsy [a permanent neurological disorder affecting movement, posture and muscle tone], Dyspnea [Shortness of Breath], Epilepsy [a brain condition that causes convulsions], Feeding Difficulty, Gastrostomy [a surgically placed tube that provides direct access to the stomach for nutrition, fluids and medications], Obstruction of the Duodenum [blockage in a part of the small intestines] and presence of Cerebrospinal Fluid drainage device [a device used to drain excess fluid from the brain to another part of the body]. Patient #1 was sent to the hospital Emergency Room on 02/04/2026 for Scrotal Edema and Urinary Retention. Patient #1 was discharged home on 02/05/2026. On 02/06/2026, Patient #1 was returned to Emergency Room via 911 due to a Respiratory event that required Cardiopulmonary Resuscitation (CPR) at home. The hospital Emergency Room chief complaint was status post cardiac arrest. The patient was intubated and admitted to the Pediatric Intensive Care Unit. The cumulative effect of these practices resulted in the HHAs failure to ensure Patient #1 received all their physician ordered medications, potentially resulting in a change in condition and transfer to a higher level of care. Immediate Jeopardy began on 12/21/25 when Patient #1 began missing the physician ordered medications. Immediate Jeopardy is a situation in which the provider's noncompliance with one or more requirements, and Conditions of Participation, has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient.

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 record review and interviews the Home Health Agency (HHA) failed to ensure physician ordered medications were administered, prompt notification to the physician and HHA administrative staff. The cumulative effect of these systemic practices resulted in the Home Health Agency’s inability to ensure 1 of 6 sampled patient's (Patient #1) needs would be met. Patient #1 did not receive physician ordered medications for 47 days out of 47 days starting 12/21/2025 to 02/04/2026. Patient #1's physician wasn't notified, and the HHA administrative staff weren't notified about patient #1 missing the physician ordered medications. Patient #1 had a start of care date of 07/28/2017 and was a 12-years-old patient. The patient was non-ambulatory and had diagnoses that included Cerebral Palsy [a permanent neurological disorder affecting movement, posture and muscle tone], Dyspnea [Shortness of Breath], Epilepsy [a brain condition that causes convulsions], Feeding Difficulty, Gastrostomy [a surgically placed tube that provides direct access to the stomach for nutrition, fluids and medications], Obstruction of the Duodenum [blockage in a part of the small intestines] and presence of Cerebrospinal Fluid drainage device [a device used to drain excess fluid from the brain to another part of the body]. Patient #1 was sent to the hospital Emergency Room on 02/04/2026 for Scrotal Edema and Urinary Retention. Patient #1 was discharged home on 02/05/2026. On 02/06/2026, Patient #1 was returned to Emergency Room via 911 due to a Respiratory event that required Cardiopulmonary Resuscitation (CPR) at home. The hospital Emergency Room chief complaint was status post cardiac arrest. The patient was intubated and admitted to the Pediatric Intensive Care Unit. Immediate Jeopardy was identified. Immediate Jeopardy began on 12/21/25 when Patient #1 began missing the physician ordered medications. Immediate Jeopardy is a situation in which the provider's noncompliance with one or more requirements, and Conditions of Participation, has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient. Ensure drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. (Refer to G0580).Ensure to promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered (Refer to G590).

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review, interviews and the Home Health Agency's (HHA) policy review, the HHA failed to ensure drugs, services, and treatments were administered only as ordered by the physician as evidenced by medication therapy not being administered as ordered due to lack of medication availability and lack of agency oversight to ensure administration in accordance with the physician-ordered plan of care for 1 of 6 patients reviewed (Patient #1). Specifically, Patient #1 did not consistently receive ordered medications (including diuretics and other prescribed medications) for 47 out of 47 days starting 12/21/2025 to 02/04/2026. Patient #1 had a change in condition on 02/04/2026 and was sent to the Emergency Room for scrotal edema and urinary retention. This deficient practice had the potential to affect all 33 patients on the agency's census at the time of survey. The findings included: Review of the last Home Health Certification and Plan of Care, Form 485, with a renewal date of 01/30/2026 and a certification period of 02/11/26 to 04/11/26 for Patient #1 documented the following medication orders: -Dantrolene powder 20 milligrams (mg): two times daily Gastric Tube (G tube) Review of the MayoClinic.org revealed the following medication reasons for use. [This medication is a skeletal muscle relaxer used for managing chronic spasticity from cerebral palsy] -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day G tube. [This medication is used to decrease stomach acid production] -Furosemide 40mg/4ml oral solution: 16mg every 12 hours G tube [This medication is used to treat fluid retention] -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily G tube [This medication is used constipation] -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours G tube [This medication is used to prevent or treat low blood potassium levels] -Spironolactone 25mg tablet: give 25mg every 12 hours G tube [This medication is used to treat fluid retention] -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily G tube [This medication is a vitamin supplement] -Singulair 5mg tablet: give 5mg everyday G tube [This medication is used to treat seasonal allergies and/or to prevent chronic asthma symptoms] -Sodium Chloride 1 gram tablet: give 2 grams two times daily G tube [This medication is used to treat or prevent low sodium] The Home Health Certification and Plan of Care for 02/11/2026 to 04/11/2026 documented diagnoses that included: Cerebral Palsy [a permanent neurological disorder affecting movement, posture, and muscle tone] and Dyspnea [shortness of breath], Epilepsy [a brain condition that causes convulsions], Feeding Difficulty, Gastrostomy [a surgically placed tube that provides direct access to the stomach for nutrition, fluids and medications], Obstruction of the Duodenum [blockage in a part of the small intestines] and presence of Cerebrospinal Fluid drainage device [a device used to drain excess fluid from the brain to another part of the body]. The orders for Staff Discipline/Title and treatment orders were listed as: -Skilled Nursing: Maxim Healthcare Services to provide skilled nursing services 24 hours per day, 7 days per week for 60 days and to include Family Home Health Aide services up to 40 hours per week for the 60-day certification period. -Treatments: Skilled nurse to follow Medical Doctor (MD) orders as per Plan of Care (POC) and notify MD/clinical supervisor of patient changes. -Medication Administration: Medication to be administered by Maxim nurse during Maxim shifts and medications to be administered by parents when Maxim is not present. (Employee C & F are the parents of patient #1) -Administer orders per physician. Review of Patient #1’s Care Plan interventions documented on the Home Health Certification and Plan of Care for 02/11/2026 to 04/11/2026 included: Medication regime review, Skilled Nursing: Skilled nurse to assess knowledge/instruct Primary caregiver on drug regimen including high risk medications in certification period. PCG (patient caregiver) stated goal: For (Patient #1) to continue to remain healthy with no infections or hospital visits. Care Plan interventions included: Skilled Nursing: Report significant changes to MD (Medical Doctor)/Clinical Supervisor. Review of Patient #1’s Care Summary documented the patient was seen on 01/26/26 for a routine recertification and supervisory visit in the family home with the agency’s nurse present (Employee H, Registered Nurse). "His last PCP (primary care physician) visit was in October 2025 for a sick visit by telehealth. I will follow up with dad about scheduling visits with annual visits with his providers. There were no reported changes to (Patient #1's) medications or treatment plan." The care summary report documented under Appropriateness: "(Patient #1) continues to receive skilled nursing services for enteral, oxygen management and medication administration." Review of Patient #1’s weekly medication administration record (MAR) dated from 12/21/25- 12/27/25 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 18 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 7 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 4 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 12/28/25-1/3/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 3 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24) was recorded as not administered 2 times out of 7 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 01/4/26-01/10/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 13 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24 was recorded as not administered 1 time out of 7 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 1 time out of 14 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 01/11/26-01/17/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24) was recorded as not administered 4 times out of 7 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 1 time out of 14 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 01/18/26-01/24/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 9 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 1 time out of 14 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 01/25/26-01/31/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 16 times out of 16 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 11 times out of 11 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 11 times out of 11 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 12 times out of 12 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 6 times out of 6 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 8 times out of 11 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 11 times out of 11 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 10 times out of 12 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 02/01/26-02/06/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24) was recorded as not administered 4 times out of 7 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered1 times out of 14 doses. On 03/02/26 at 2:46PM, during an interview, the Director of Nursing (DON)/Clinical Manager stated she was not aware of Patient #1 not receiving his medications as ordered. The DON/Clinical Manager stated the patient’s medication administration records (MAR) are mailed to the office weekly for filing and that the MARs are not reviewed by anyone before being filed in the patient’s records. On 03/03/26 at 1:45pm, during an interview with Employee C, a parent of patient #1/Family Home Health Aide he was asked if he was trained to administer medications to patient #1; he stated “Yes”. Employee C was asked who managed the ordering of the medications and stated, “I did”. The employee was asked if Patient #1 had ever run out of any of their medications and stated sometimes we didn't receive the medications. Employee C was asked what he would do if medications were not available and stated he would call the pharmacy and let them know. Employee C did not say, he called the pharmacy. On 03/03/36 at 3:00pm, during an interview, the Director of Nursing (DON)/Clinical Manager was asked if she was aware that Patient #1 had medications that were not administered. The DON/Clinical Manager stated “I was not aware until he went to the emergency room on 02/04/26. The DON/Clinical Manager was asked why Patient #1’s medications were not administered and stated she spoke to the nurses, and they said the child had not been to the doctor recently and was at the point where he needed to be seen to get new prescriptions. The DON/Clinical Manager was asked what the policy or protocol was for nurses and Family Home Health Aide/AMFC HHA when medications were not available; stated they should notify the agency’s office and the patient’s doctor. The DON/Clinical Manager added that the nurses, to her knowledge, did not let the office or her know that Patient #1’s medications were not available. The DON/Clinical Manager was asked if the doctor was notified that the medications were not available and stated, “I don't believe so”. On 03/03/26 at 3:10pm, during an interview, Employee B, Licensed Practical Nurse (LPN) was asked if she had cared for Patient #1 and stated “Yes”. The employee was asked what training she has received for medications not being available and stated, “We document it in the Medication Administration Record (MAR) that it's not available”. Employee B was asked if she contacts the doctor when medications are not available and stated “No, not that I'm aware of” and added “we let the parents know”. Employee B was asked about Patient #1's medications and the availability of his medications and stated “I think they had some kind of issues with the doctor being switched and they weren’t able to get the medications filled, I don’t know the full extent. He didn’t have his Furosemide for a couple weeks. He would sometimes run out of medications but then get them replenished and then run out again. I recall the Furosemide for not having it for about 3 weeks”. Employee B was asked if she calls the home health agency office if medications are not available and stated “I document daily in the chart and speak to the parents to let them know it’s not available. The Furosemide was given at 6:00am, so I work the overnight shift. I would educate the parents and document the medications that need to be refilled”. Employee B was asked if she had received any medication training regarding medications not being available since the incident, referring to the 02/06/2026 Emergency room visit with Patient #1, and stated “You mean about what happened to him? No, ma’am”. On 03/03/26 at 4:00pm, during an interview, Employee A, LPN, was asked if she had cared for Patient #1 and stated “Yes” The employee was asked what training she had received for medications not being available and stated, “If a child doesn't have the medication, we write n/a on the MAR”. Employee A was asked what n/a means and stated not available” and added “I inform the parent the medication is not available”. Employee A was asked if she contacts the doctor if a medication is not available and stated “No”, the parent will call. I would call the doctor for a change in condition, like a new cough, and I would mention the medication, but the parent would normally call the doctor if the medication needs to be refilled”. Employee A was asked if she contacts the home health agency office if medications are not available and stated, “Not directly, but I will put n/a on the MAR and that should be seen by the office”. The employee was asked if Patient #1 had instances of medications not being available and stated, “with him, the dad said the medication is coming from the pharmacy”. Employee A was asked if the medications arrived from the pharmacy and stated “not all the time”, was asked if she had received any medication training regarding medications not being available since the incident, referring to the 02/06/2026 Emergency room visit with Patient #1, and stated the DON said that if a medication is not there, next time we need to notify someone, and we would be having some training on that at some point. Employee A was asked who she was instructed to notify and stated, “just the office”. On 03/04/26 at 3:00pm, during a follow up interview, the DON/Clinical Manager was asked if she could provide any documentation to show that Patient #1’s doctor had been advised or alerted that medications were not available from 12/21/25 through 02/06/26. The DON/Clinical Manager stated she did not have any documentation to show the doctor was called or advised the medications were not available. On 03/06/26 at 12:20pm, during an interview with Employee E, a registered nurse (RN) she was asked if she had provided care for Patient #1 and stated “Yes”. The employee was asked about the availability of the patient's medications and stated, “throughout working there, a lot of the medications weren’t available, the dad was in control of the medications”. Employee E was asked if she had contacted the doctor about the medications not being available and stated “I called one time the doctor to say he was out of Furosemide, but the doctor said he couldn’t send the scripts until they saw the patient. I don’t remember when that was, maybe a month ago. I don’t recall the doctor’s name”. Employee E was asked if she had called the doctor any other time to report Furosemide or other medications not being available and stated “No”. The employee was asked if she had ever notified the home health agency office about the medications not being available and stated “Yes, I did notify and speak to the clinical manager when there were clinical issues. I think we notify the office about the missing medications, they know”. Employee E was asked if she had received any medication training regarding medications not being available since the incident, referring to the 02/06/2026 Emergency room visit with patient #1, and stated “No, I have not”. On 03/06/2026 at 10:27AM, patient #1's primary care physician was called, and a message was left for to return the phone call. A return call wasn't received. Review of the Home Health Agency’s policy titled, "Administration and Documentation of Medications" (4/11/2016, revised 10/6/2025) documents: Purpose: To provide guidelines for the safe administration of medications by licensed personnel. Procedure: -5.1 The nurse will provide instructions to the patient and/or family/caregiver regarding current medications on a continuing basis. The instructions will include medication administration... -5.4 Nurses will document medications administered on the Medication Administration Record. Only those medications that the nurse administers or oversees the administration of shall be documented on the Medication Administration Record. -5.5.2 Medications refused, removed, and/or omitted will be indicated on the Medication Administration Record, and with an explanation made in the medical record. The office clinical leader or clinical designee and attending physician will be notified. Review of the home health agency’s job description for Licensed Practical Nurse (LPN) (effective date 6/18/2012, updated 5/27/2016) documents: For clinical matters, reports to: Registered Nurse, Clinical Supervisor, and/or Director of Clinical Operations or Unit Manager. Position description: The LPN assumes responsibility and accountability for the application of the nursing process and the delivery of patient care under the supervision of a registered nurse. The LPN provides services in accordance with Maxim philosophy, standards, and policies. Essential duties and responsibilities included: Uses the nursing process to plan, implement, and evaluate patient care.Demonstrates on each assignment the provision of skilled nursing care rendered in accordance with prescribed orders.Identifies and documents changes in patient’s both physiological and psychosocial condition.Notifies Director/Supervisor if applicable of the following:Physician notification to obtain necessary orders for intervention(s) per state regulationsChanges in patient conditionAdheres to Maxim’s policies and procedures and applicable protocolsIdentifies and prioritizes actions based on patient care requirements 9. Performs interventions, treatments, and medication administration according to identified priorities, plan of care, facility policies, and patient care outcome standards as applicable. Monitors and documents effectiveness of interventions, treatments, and medications 13. Communicates observations and significant changes in patient status to Director of Clinical Services and/or Clinical Supervisor, or licensed designee. Review of the home health agency’s job description for Registered Nurse (RN) (effective date 11/9/2010, updated: 11/10/2022) documents: Reports to: Clinical Supervisor, and/or Director of Clinical Operations or Unit Manager. Position description: The RN is responsible for providing and documenting skilled nursing care on accordance with the care plan developed for each individual patient and within the physician orders. The RN provides services in accordance with Maxim philosophy, standards, and policies. Essential duties and responsibilities included: Assess and evaluates patient nursing needs regularly. Utilizes the nursing process to plan, implement, and evaluate patient care and/or services provided to patients receiving contracted services, as required. Initiates plan of care when directed and requests from prescriber and necessary revisions as patient status and needs change. Incorporates therapeutic, preventive, and rehabilitative nursing actions based on patient diagnoses and established goals. Intervenes as applicable in response to changes in patient condition and reports such changes to appropriate physician or supervisor. Administers medications and treatments as prescribed, as well as monitors and documents effectiveness of interventions. Reviews plan of care and program protocols and identifies areas for healthcare teaching/education and communicates this information as needed. Adheres to Maxim policy, procedure, and applicable protocols. Review of the home health agency’s job description for Family Home Health Aide-Florida Specific (effective date: 6/18/2012) documents: For clinical matters reports to: Registered Nurse, Clinical Supervisor and/or Clinical Manager Position description: The Family Home Health Aide (FHHA) is member of the health care team who works under the supervision of a registered nurse. The FHHA performs various personal care services, as necessary, to meet the patient’s needs. A registered nurse may delegate basic nursing skills tailored to the child’s individualized care needs as specified in the ordering providers plan of care, as applicable, to a FHHA in accordance with Florida statutes following clinical training and competency validation. The FHHA provides services in accordance with Maxim’s philosophy, standards, and policies. Essential duties and responsibilities: Observes and documents patient condition and reports and changes to the assigned supervisor. Communicates on a constant, clear, and effective way with the patient, family/caregiver, and office. Successful completion of Maxim’s Competency Program. Must follow patient’s plan of care and complete all tasks assigned. Adherence to Maxim’s policies and procedures, documentation, care procedures, and standards of personal and professional boundaries and conduct. Documents all care provided, to include patient response to treatments, and medication administration per Maxim policy. Ability to live by Maxim’s company-wide commitment to quality and competent patient care. Responsible for completing all assigned trainings in a timely manner. Performs interventions, treatments, and medication administration, according to identified priorities, plan of care, facility policies and patient care outcome standards as delegated. Monitors the safety and effectiveness of environment and equipment. Performs other duties as assigned.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and staff interviews, the Home Health Agency failed to promptly alert the physician to changes in the patient’s condition or needs that suggested outcomes were not being achieved and/or that the plan of care should be altered, as evidenced by failure to timely notify the physician/allowed practitioner when ordered medication therapy was not being administered as ordered, for 1 of 6 sampled patients (Patient #1). This deficient practice had the potential to affect all 33 patients on the agency census at the time of survey. The findings included: Review of the last Home Health Certification and Plan of Care, Form 485, with a renewal date of 01/30/2026 and a certification period of 02/11/26 to 04/11/26 for Patient #1 documented the following medication orders: -Dantrolene powder 20 milligrams (mg): two times daily Gastric Tube (G tube). Review of the MayoClinic.org revealed the following medication reasons for use. [This medication is a skeletal muscle relaxer used for managing chronic spasticity from cerebral palsy] -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day G tube. [This medication is used to decrease stomach acid production] -Furosemide 40mg/4ml oral solution: 16mg every 12 hours G tube [This medication is used to treat fluid retention] -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily G tube [This medication is used constipation] -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours G tube [This medication is used to prevent or treat low blood potassium levels] -Spironolactone 25mg tablet: give 25mg every 12 hours G tube [This medication is used to treat fluid retention] -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily G tube [This medication is a vitamin supplement] -Singulair 5mg tablet: give 5mg everyday G tube [This medication is used to treat seasonal allergies and/or to prevent chronic asthma symptoms] -Sodium Chloride 1 gram tablet: give 2 grams two times daily G tube [This medication is used to treat or prevent low sodium] The Home Health Certification and Plan of Care from 02/22/2026 to 04/11/2026 documented diagnoses that included: Cerebral Palsy [a permanent neurological disorder affecting movement, posture, and muscle tone] and Dyspnea [shortness of breath]. The orders for discipline and treatment were listed as: -Skilled Nursing: Maxim Healthcare Services to provide skilled nursing services 24 hours per day, 7 days per week for 60 days and to include Family Home Health Aide services up to 40 hours per week for the 60-day certification period. -Treatments: Skilled nurse to follow MD orders as per Plan of Care (POC) and notify MD/clinical supervisor of patient changes. -Education: Educate primary caregiver on care provided, disease process, related equipment, medications, medications, signs/symptoms reportable and emergency interventions as needed. Care Plan interventions included: Problem- Medication regime review; Skilled nurse to assess knowledge/instruct Primary caregiver on drug regimen including high risk medications in certification period, skilled nurse report significant changes to MD (Medical Doctor)/Clinical Supervisor; Problem: Increased emergency department (ED)/hospital risk due to risk of respiratory distress. PCG (patient caregiver) stated goal: to continue to remain healthy with no infections or hospital visits; skilled nurse to Instruct and educate primary caregiver in oxygen usage and precautions re: ED/hospitalization risk, Instruct and educate primary caregiver to monitor for signs and symptoms of respiratory distress to reduce ED/hospitalization risk; Problem: Impaired Respiratory Status. Treatments: Skilled Nurse-Oxygen: report signs and symptoms of decreased saturation not resolved per interventions as ordered by the physician, Pulse oximeter to be on continuously, maintain sats (saturation) equal or greater than 92%. Skilled Nurse/Care team to instruct primary caregiver in respiratory disease process and signs and symptoms of complications, specifically shortness of breath, infection, to assess/monitor availability of emergency equipment/supplies, presence of back up equipment, and knowledge/compliance with emergency protocol, Skilled nurse to assess/monitor/instruct primary caregiver in respiratory disease process, monitoring of respiratory status including signs and symptoms of complications, prescribed equipment care/management, troubleshooting, related emergency interventions, and when to notify emergency medical services (EMS) and/or Medical Doctor (MD). Review of Patient #1’s Care Summary documented the patient was seen on 01/26/26 for a routine recertification and supervisory visit in the family home with the agency’s nurse present, Employee H, Registered Nurse. "His last PCP (primary care physician) visit was in October 2025 for a sick visit by telehealth. I will follow up with dad about scheduling visits with annual visits with his providers. There were no reported changes to (Patient #1's) medications or treatment plan." The care summary report documented under Appropriateness: "(Patient #1) continues to receive skilled nursing services for enteral, oxygen management and medication administration." Review of skilled nursing note for Patient #1 dated start date/time: 02/05/26 9:50pm- end date/time: 02/06/26 6:05am, authored by Employee B, LPN documents a note dated/timed 02/06/26 3:59am: “Noted decreased sat(saturation) while on BiPap [bilevel positive airway machine that assists with breathing by delivering pressurized air through a mask] Pt (patient) repositioned, suctioned, mask adjusted, head of bed elevated, chest physical therapy [a technique involving rhythmic clapping on the chest or back to loosen mucus from the lungs] performed, deep suctioning performed by dad. 02 (oxygen) sat at present 85% on BiPap. Maxim notified but no response”. "02/06/26 4:17am: “Return call made to Maxim. Awaiting callback. Father acknowledged critical status and need for EMS but says he "will call if he doesn't get better". Risks explained and acknowledged”. "02/06/26 5:57am: “02 sat at 92% on BiPap. Educated dad if patient becomes unstable, please call Emergency Medical Services (EMS). Patient left in care of nurse/family”. Review of skilled nursing note for Patient #1 dated start/time: 02/06/26 6:03am-end date/time: 02/06/26 2:00pm, authored by Employee E, RN documents: 02/06/26 6:12am “Oxygen saturation 76%Type: 02 liters per minute: 5”. 02/06/26 6:42am: “Patient 02 84-88%. Patient has a lot of thick secretions. Patient is on 5 liters of 02”. 02/06/26 8:14am: “Patient 02 is 81”. 02/06/26 11:55am: “Patient 02 is 71. Gave patient lactulose. baclofen, spironolactone, gabapentin, patient tolerate meds”. 02/06/26 1:08pm: “Patient 02 72 Patient heartrate 126”. 02/06/26 1:09pm: “Dad held the feeding during 6am-1pm”. 02/06/26 1:12pm: “Patient did not urine 6am-2pm” 02/06/26 1:17pm: “Gave patient Keppra, Clonazepam, Hydrocortisone. Patient tolerate meds. Patient left in care of dad”. On 03/02/26 at 2:45pm, during an interview, the Director of Nursing (DON)/Clinical Manager was asked to review the events on 02/06/26 leading up to Patient #1 being transported to the hospital. The DON/Clinical Manager stated that “on Feb. 6, 2026, I received a call in the evening around 10pm from the nurse (Employee B, LPN) who was showing up for her shift. When she got to the patient’s home, no one was there, and she called the patient’s dad. He informed her they were at (local) Children’s Hospital. She stated dad told her he thought the patient had died, and that EMS had been called to the home and transported to the hospital. The patient had been put on life support, according to the dad”. The DON/Clinical Manager continues, “The next day, 02/07/26, I called the hospital to check on the patient’s status, they told me he had fevers of 39 degrees Celsius. I got an update that he was intubated, one pupil was fixed. I asked if they would keep me updated with his status. I reviewed all the nursing notes because he had been to the Emergency Room (ER) on 02/04/26, because he had not voided for 8 hours, and his scrotum was noted to be swollen by our nurse. Family took him to the hospital for that, and it transpired the child had not had his ordered furosemide for 3 weeks, and had not been to the doctors, and family had not been compliant with doctors' visits. The pharmacy wrote a short term for the Furosemide, 7 days' worth, with instructions to follow up with their doctor, the ordering physician. While he was at the hospital the first time, 2/4/26, he received intravenous furosemide and potassium, which helped to improve the swelling. He had been voiding that Thursday (2/5/26) once back home, but on Friday (2//6/26) they said he was on his BiPap was needing 5 liters of oxygen, his maximum amount, and our nurse was having trouble maintaining his sats. I recommended the nurse call 911 to transport to children’s hospital. The family declined calling 911; that RN shift ended at 2pm on 02/06/26. At that time dad’s shift for the Family Home Health Aide began. Dad went administer a breathing treatment at 8pm, he removed the mask and the patient was gasping, dad checked the pulse and there was no pulse. He called out to his wife, also a Family Home Health Aide, and she commenced cardiopulmonary resuscitation (CPR). The dad called 911, it was 5-10 minutes until EMS arrived and they transported him to the hospital”. On 03/06/26 at 11:40am, during a follow-up interview, the DON/Clinical Manager was asked to review the skilled nurse visit made by Employee E, RN, to Patient #1 that started at 6:00am. She stated she called me at around 12 noon that day and told me his sats were around 71%, I recommended they call 911 and get him transported. Obviously, she did not follow my advice, told me she recommended to the family they call 911 but the mother didn’t want to do that and the dad moved the bed from the bedroom into the living room. She finished her shift at 2pm, and I had no further communication with her. She signed off care to dad, and he started his shift as AMFC HHA at 2pm, notified of the patient’s 02 sats down to as low as 72% and no urine output for the shift. She stated only about the oxygen sats. I don’t recall if she mentioned the lack of urine output. She was asked if the patient's doctor was notified of the patient’s oxygen sats down to as low as 72% and no urine output for the shift and stated no. The DON/Clinical Manager was asked if that would be an expectation to notify the doctor of a change in condition and stated “Yes”. The DON/Clinical Manager was asked if she had advised Employee E to notify the doctor of the change in condition and stated “No, I only advised her to call 911”. The DON/Clinical Manager was asked if Employee E, RN let her know that the family declined to call 911 and stated “when I spoke to her on Monday (02/09/26) to get a clearer picture of what happened, she told me then. The DON/Clinical Manager was asked if Employee E had provided her with any update prior to 02/09/26 and stated, “no she didn’t”. The DON was asked if Employee E has received any additional training regarding patient change in condition since this incident referring to the 02/06/2026 Emergency room visit with Patient #1, and stated, “No”. On 03/06/26 at 12:29pm, during an interview, Employee E, RN was asked if she had cared for Patient #1 on 02/06/26 and stated “Yes, from 6:00am until 2:00pm. The employee was asked if she had cared for this patient previously and stated “Yes, regularly on Fridays, was asked to review what occurred on her shift 02/06/26 and stated “I came in at 6:00am, and his oxygen sat was low. Dad was in the living room, the whole day his oxygen saturation was dropping, I think in the 60s, 70s, around that. The dad really took over, so I gave the breathing treatments, and it still didn’t go up. I put him on his BiPap and still didn’t go up. I called Maxim and spoke to (DON), and she told me to encourage the dad to call 911 but the parents didn’t want to do that. I did mention it to them, but they didn’t answer me and kept providing the care to try to get the oxygen saturation back up. Employee E was asked if she called the doctor to report this change in condition and stated “No, the dad really controlled everything, it never came up to call to the doctor, he really just needed to go to the hospital, he was too far gone for a doctor's call”. The employee was asked when she ended her shift that day and stated 2:00pm, was asked who's care the patient was left in and stated the dad”. Employee E was asked if she could describe the patient's condition at that time and stated he was the same, low oxygen sats, no improvement, was asked if she called the home health agency back at that time to report on the patient's condition and the parent's refusal to call 911 and stated, “No, I didn't”. Review of Patient #1’s weekly medication administration record (MAR) dated from 12/21/25- 12/27/25 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 18 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 7 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 4 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 12/28/25-1/3/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 3 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24) was recorded as not administered 2 times out of 7 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 01/4/26-01/10/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 13 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24 was recorded as not administered 1 time out of 7 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 1 time out of 14 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 01/11/26-01/17/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24) was recorded as not administered 4 times out of 7 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 1 time out of 14 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 01/18/26-01/24/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 9 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 1 time out of 14 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 01/25/26-01/31/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 16 times out of 16 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 11 times out of 11 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 11 times out of 11 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 12 times out of 12 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 6 times out of 6 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 8 times out of 11 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 11 times out of 11 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 10 times out of 12 doses. Review of Patient #1’s weekly medication administration record (MAR) dated from 02/01/26-02/06/26 documented the following: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24) was recorded as not administered 4 times out of 7 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered1 times out of 14 doses. On 03/03/26 at 3:00pm, during an interview, the Director of Nursing (DON)/Clinical Manager was asked if she was aware that Patient #1 had medications that were not administered. The DON/Clinical Manager stated “I was not aware until he went to the emergency room on 02/04/26. The DON/Clinical Manager was asked why Patient #1’s medications were not administered and stated she spoke to the nurses, and they said the child had not been to the doctor recently and was at the point where he needed to be seen to get new prescriptions. The DON/Clinical Manager was asked what the policy or protocol was for nurses and AMFC HHA when medications were not available; stated they should notify the agency’s office and the patient’s doctor. The DON/Clinical Manager added that the nurses, to her knowledge, did not let the office or her know that Patient #1’s medications were not available. The DON/Clinical Manager was asked if the doctor was notified that the medications were not available and stated, “I don't believe so”. On 03/03/26 at 3:10pm, during an interview, Employee B, Licensed Practical Nurse (LPN) was asked if she had cared for Patient #1 and stated “Yes”. The employee was asked what training she has received for medications not being available and stated, “We document it in the MAR that it's not available”. Employee B was asked if she contacts the doctor when medications are not available and stated “No, not that I'm aware of” and added “we let the parents know”. Employee B was asked about Patient #1's medications and the availability of his medications and stated “I think they had some kind of issues with the doctor being switched and they weren’t able to get the medications filled, I don’t know the full extent. He didn’t have his Furosemide for a couple weeks. He would sometimes run out of medications but then get them replenished and then run out again. I recall the Furosemide for not having it for about 3 weeks”. Employee B was asked if she calls the home health agency office if medications are not available and stated “I document daily in the chart and speak to the parents to let them know it’s not available. The Furosemide was given at 6:00am, so I work the overnight shift. I would educate the parents and document the medications that need to be refilled”. Employee B was asked if she had received any medication training regarding medications not being available since the incident, referring to the emergency room visit on 02/06/26 with patient #1, and stated, “You mean about what happened to him? No, ma’am”. On 03/03/26 at 4:00pm, during an interview, Employee A, LPN, was asked if she had cared for Patient #1 and stated “Yes” The employee was asked what training she had received for medications not being available and stated, “If a child doesn't have the medication, we write n/a on the MAR”. Employee A was asked what n/a means and stated not available” and added “I inform the parent the medication is not available”. Employee A was asked if she contacts the doctor if a medication is not available and stated “No”, the parent will call. I would call the doctor for a change in condition, like a new cough, and I would mention the medication, but the parent would normally call the doctor if the medication needs to be refilled”. Employee A was asked if she contacts the home health agency office if medications are not available and stated, “Not directly, but I will put n/a on the MAR and that should be seen by the office”. The employee was asked if Patient #1 had instances of medications not being available and stated, “with him, the dad said the medication is coming from the pharmacy”. Employee A was asked if the medications arrived from the pharmacy and stated “not all the time”, was asked if she had received any medication training regarding medications not being available since the incident, referring to the emergency room visit on 02/06/2026 with Patient #1 and stated the DON said that if a medication is not there, next time we need to notify someone, and we would be having some training on that at some point. Employee A was asked who she was instructed to notify and stated, “just the office”. On 03/04/26 at 3:00pm, during a follow up interview, the DON/Clinical Manager was asked if she could provide any documentation to show that Patient #1’s doctor had been advised or alerted that medications were not available from 12/21/25 through 02/06/26. The DON/Clinical Manager stated she did not have any documentation to show the doctor was called or advised the medications were not available. On 03/06/26 at 12:20pm, during an interview with Employee E, a Registered Nurse (RN) she was asked if she had provided care for Patient #1 and stated, “Yes”. The employee was asked about the availability of the patient's medications and stated, “throughout working there, a lot of the medications weren’t available, the dad was in control of the medications”. Employee E was asked if she had contacted the doctor about the medications not being available and stated “I called one time the doctor to say he was out of Furosemide, but the doctor said he couldn’t send the scripts until they saw the patient. I don’t remember when that was, maybe a month ago. I don’t recall the doctor’s name”. Employee E was asked if she had called the doctor any other time to report Furosemide or other medications not being available and stated “No”. The employee was asked if she had ever notified the home health agency office about the medications not being available and stated “Yes, I did notify and speak to the clinical manager when there were clinical issues. I think we notify the office about the missing medications, they know”. Employee E was asked if she had received any medication training regarding medications not being available since the incident, referring to the emergency room visit on 02/06/26 with patient #1 and stated “No, I have not”. Review of the home health agency policy titled, "Administration and Documentation of Medications" (4/11/2016, revised 10/6/2025) documents: Purpose: To provide guidelines for the safe administration of medications by licensed personnel. Procedure: 5.5.2 Medications refused, removed, and/or omitted will be indicated on the Medication Administration Record, and with an explanation made in the medical record. The office clinical leader or clinical designee and attending physician will be notified. Review of the home health agency policy titled, “Care Coordination/Case Conference” (effective date 3/3/2011, revised 1/16/2026) documents: Purpose: To ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. To facilitate effective communication amongst the health care team. Policy: Care coordination is accomplished through communication with the members of the health care team. Procedure: Direct care staff shall communicate changes in patient status among the assigned personnel and the office clinical leader or clinical designee. Direct care staff will communicate changes in a timely manner via telephone, one-on-one meeting, case conferences, and/or home visits. Documentation of communications will be included in the medical record on a communication note, case conference note, clinical visit note, supervisory note, or in the system of record. Documentation will include: the date and time of the communication, individuals involved with the communication, information discussed, and the outcome of the communication. Review of the home health agency’s job description for Licensed Practical Nurse (LPN) (effective date 6/18/2012, updated 5/27/2016) documents: For clinical matters, reports to: Registered Nurse, Clinical Supervisor, and/or Director of Clinical Operations or Unit Manager. Position description: The LPN assumes responsibility and accountability for the application of the nursing process and the delivery of patient care under the supervision of a registered nurse. The LPN provides services in accordance with Maxim philosophy, standards, and policies. Essential duties and responsibilities included: Uses the nursing process to plan, implement, and evaluate patient care.Demonstrates on each assignment the provision of skilled nursing care rendered in accordance with prescribed orders.Identifies and documents changes in patient’s both physiological and psychosocial condition.Notifies Director/Supervisor if applicable of the following:Physician notification to obtain necessary orders for intervention(s) per state regulationsChanges in patient conditionAdheres to Maxim’s policies and procedures and applicable protocolsIdentifies and prioritizes actions based on patient care requirements 9. Performs interventions, treatments, and medication administration according to identified priorities, plan of care, facility policies, and patient care outcome standards as applicable. Monitors and documents effectiveness of interventions, treatments, and medications 13. Communicates observations and significant changes in patient status to Director of Clinical Services and/or Clinical Supervisor, or licensed designee. Review of the home health agency’s job description for Registered Nurse (RN) (effective date 11/9/2010, updated: 11/10/2022) documents: Reports to: Clinical Supervisor, and/or Director of Clinical Operations or Unit Manager. Position description: The RN is responsible for providing and documenting skilled nursing care on accordance with the care plan developed for each individual patient and within the physician orders. The RN provides services in accordance with Maxim philosophy, standards, and policies. Essential duties and responsibilities included: Assess and evaluates patient nursing needs regularly. Utilizes the nursing process to plan, implement, and evaluate patient care and/or services provided to patients receiving contracted services, as required. Initiates plan of care when directed and requests from prescriber and necessary revisions as patient status and needs change. Incorporates therapeutic, preventive, and rehabilitative nursing actions based on patient diagnoses and established goals. Intervenes as applicable in response to changes in patient condition and reports such changes to appropriate physician or supervisor. Administers medications and treatments as prescribed, as well as monitors and documents effectiveness of interventions. Reviews plan of care and program protocols and identifies areas for healthcare teaching/education and communicates this information as needed. Adheres to Maxim policy, procedure, and applicable protocols. Review of the home health agency’s job description for Family Home Health Aide-Florida Specific (effective date: 6/18/2012) documents: For clinical matters reports to: Registered Nurse, Clinical Supervisor and/or Clinical Manager Position description: The Family Home Health Aide (FHHA) is member of the health care team who works under the supervision of a registered nurse. The FHHA performs various personal care services, as necessary, to meet the patient’s needs. A registered nurse may delegate basic nursing skills tailored to the child’s individualized care needs as specified in the ordering providers plan of care, as applicable, to a FHHA in accordance with Florida statutes following clinical training and competency validation. The FHHA provides services in accordance with Maxim’s philosophy, standards, and policies. Essential duties and responsibilities included: Observes and documents patient condition and reports and changes to the assigned supervisor. Communicates on a constant, clear, and effective way with the patient, family/caregiver, and office. Successful completion of Maxim’s Competency Program. Must follow patient’s plan of care and complete all tasks assigned. Adherence to Maxim’s policies and procedures, documentation, care procedures, and standards of personal and professional boundaries and conduct. Documents all care provided, to include patient response to treatments, and medication administration per Maxim policy. Ability to live by Maxim’s company-wide commitment to quality and competent patient care. Responsible for completing all assigned trainings in a timely manner. Performs interventions, treatments, and medication administration, according to identified priorities, plan of care, facility policies and patient care outcome standards as delegated. Monitors the safety and effectiveness of environment and equipment. Performs other duties as assigned.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to provide services as per the physician's plan of care for 1 of 6 sampled patients reviewed (Patient#1). Refer G580 and G590. The findings included: Review of Patient #1’s medical record for the period 12/21/25 through 02/06/26 revealed physician ordered medications to include diuretics (Furosemide, Spironolactone), Potassium, Dantrolene, Famotidine, and Pyridoxine) were not consistently available and therefore not administered at various points during the 47-day review period. Review of Patient #1’s Care Summary documented the patient was seen on 01/26/26 for a skilled recertification and supervisory visit in the family home with the agency’s nurse present, Employee H, Registered Nurse. "His last PCP (primary care physician) visit was in October 2025 for a sick visit by telehealth. I will follow up with dad about scheduling visits with annual visits with his providers. There were no reported changes to (Patient #1's) medications or treatment plan." The care summary report documented under Appropriateness: "(Patient #1) continues to receive skilled nursing services for enteral, oxygen management and medication administration." Review of Patient #1’s weekly medication administration record (MAR) dated 12/21/25 to 12/27/25; 01/04/26 to 01/10/26; 01/11/26 to 01/17/26; 01/18/26 to 01/24/26; 01/25/26 to 01/31/26; and 02/01/26-02/06/26, documented the patient’s medications ordered by the physician were not consistently available and therefore not administered at various points during the 47-day review period. Further review revealed the record lacked written evidence that the HHA promptly notified the relevant physician(s)/allowed practitioner(s) and obtained timely plan-of-care modification when ordered medication administration was not occurring. The review revealed that Patient #1 was sent to emergency room on 02/04/26 for scrotal edema and urinary retention. On 03/02/26 at 2:46PM, during an interview, the Director of Nursing (DON)/Clinical Manager stated she was not aware of Patient #1 not receiving his medications as ordered. The DON/Clinical Manager stated the patient’s medication administration records (MAR) are mailed to the office weekly for filing and that the MARs are not reviewed by anyone before being filed in the patient’s records. Review of the Clinical Manager job description effective date 01/22/2024, read, “The Clinical Manager is responsible for the clinical oversight of business lines, including clinical personnel oversight and management.”

A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the Home Health Agency(HHA) failed to ensure a home health aide met qualification requirements prior to furnishing home health aide services, as evidenced by the HHA assigning a home health aide to provide home health aide services without documentation of a successfully completed qualifying training and competency evaluation for 1 of 3 sampled home health aide personnel files reviewed (Employee C). The findings include: Review of Employee C’s personnel files “Employee Training Transcript” documented the employee completed a total of 4 hours and 52 minutes of online home health aide training prior to providing patient care. The online training curriculum was identified by the HHA as set at 68 hours; however, the employee transcript reflected 4 hours and 52 minutes as the time captured/completed. On 03/05/26 at 11:30am, during an interview, the DON was asked to verify how many hours of training Employee C had completed prior to providing patient care according to the employee training transcript and stated she was not sure. The DON was asked if this training takes place in the employees’ home, the HHA office, or elsewhere and stated in their homes. The DON was asked how the HHA verifies the employee actually completed the required hours of training and stated, “I can’t answer that”. The DON was asked to confirm that all this training was completed online and not reviewed by the HHA for the hours spent on training and stated “Yes, it's online training, and it was not reviewed by myself”. On 03/05/26 at 11:31 am, during an interview, Employee D, Field Office Support Manager, stated corporate has told her they (home health aide) receive credit for 68 hours of training, but depending on the person, some could get through the training quicker than others, they can click through the slides faster. The employee was asked to confirm that the transcript indicated if the employee was paid 4 hours 52 minutes out of the 68 hours of training assigned and stated, “Yes”. The employee was asked if that's how long it took the employee to complete the training and stated, “Yes”.

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 record review and interviews the Home Health Agency (HHA) failed to ensure the Administrator demonstrated responsibility for all day-to-day operations and the Director of Nursing (DON) failed to provide supervision of all personnel who provided direct patient care to ensure ordered medications were consistently available/administered and failed to ensure timely escalation/physician notification when ordered medication administration was not occurring for 1 of 6 sampled record reviewed (Patient #1). (Refer to G0948 and G0958) The cumulative effect of these systemic practices resulted in the Home Health Agency’s inability to ensure 1 of 6 sampled patient's (Patient #1) needs would be met. Patient #1 did not receive physician ordered medications for 47 days out of 47 days starting 12/21/2025 to 02/04/2026. Patient #1's physician wasn't notified, and the HHA administrative staff weren't notified about patient #1 missing the physician ordered medications. Patient #1 had a start of care date of 07/28/2017 and was a 12-years-old patient. The patient was non-ambulatory and had diagnoses that included Cerebral Palsy [a permanent neurological disorder affecting movement, posture and muscle tone], Dyspnea [Shortness of Breath], Epilepsy [a brain condition that causes convulsions], Feeding Difficulty, Gastrostomy [a surgically placed tube that provides direct access to the stomach for nutrition, fluids and medications], Obstruction of the Duodenum [blockage in a part of the small intestines] and presence of Cerebrospinal Fluid drainage device [a device used to drain excess fluid from the brain to another part of the body]. Patient #1 was sent to the hospital Emergency Room on 02/04/2026 for Scrotal Edema and Urinary Retention. Patient #1 was discharged home on 02/05/2026. On 02/06/2026, Patient #1 was returned to Emergency Room via 911 due to a Respiratory event that required Cardiopulmonary Resuscitation (CPR) at home. The hospital Emergency Room chief complaint was status post cardiac arrest. The patient was intubated and admitted to the Pediatric Intensive Care Unit. Immediate Jeopardy was identified. Immediate Jeopardy began on 12/21/25 when Patient #1 began missing the physician ordered medications. Immediate Jeopardy is a situation in which the provider's noncompliance with one or more requirements, and Conditions of Participation, has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient. The findings include: The Home Health Agency Administrator failed to ensure he was responsible for the day-to-day operations. (Refer to G0948).The home health agency (HHA) Director of Nursing (DON) failed to provide supervision of all personnel who provided direct patient care to ensure ordered medications were consistently available/administered and failed to ensure timely escalation/physician notification when ordered medication administration was not occurring for 1 of 6 sampled record reviewed (Patient #1). (Refer to G0958)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on the interview and record review, the home health agency failed to ensure that the administrator was responsible for the day-to-day operations of the agency, such as being responsible for the oversight of the office quality management system and organize and direct the ongoing functions of the office. The findings included: During an interview on 03/02/26 at 3:05 PM, the Administrator stated, “the job entails operations of the agency and added he is not clinical, so he does not get involved. He leaves the clinical to the Director of Nursing (Clinical Manager) who handles anything clinical, staff scheduling, patient assignment and review of clinical operations were managed by office staff and if he was needed, they could contact him, but the Director of Nursing (Clinical Manager) is here in office and is available”. Review of the Administrator job description with an effective date of 01/01/2024 reads, “in the capacity of office administrator and is responsible for all day-to-day operations of the office and responsible for the oversight of the office quality management system

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on record review, interview, and the home health agency’s policy review, the home health agency (HHA) Clinical Manager/Director of Nursing (DON) failed to provide supervision of all personnel who provided direct patient care to ensure ordered medications were consistently available/administered and failed to ensure timely escalation/physician notification when ordered medication administration was not occurring for 1 of 6 sampled record reviewed (Patient #1). Refer to G0580 and G0590. The findings include: Review of Patient #1’s Care Summary documented the patient was seen on 01/26/26 for a skilled recertification and supervisory visit in the family home with the agency’s nurse present Employee H, Registered Nurse. "His last PCP (primary care physician) visit was in October 2025 for a sick visit by telehealth. I will follow up with dad about scheduling visits with annual visits with his providers. There were no reported changes to (Patient #1's) medications or treatment plan." The care summary report documented under Appropriateness: "(Patient #1) continues to receive skilled nursing services for enteral, oxygen management and medication administration." Review of Patient #1’s weekly medication administration record (MAR) dated 12/21/25 to 12/27/25; 01/04/26 to 01/10/26; 01/11/26 to 01/17/26; 01/18/26 to 01/24/26; 01/25/26 to 01/31/26; and 02/01/26-02/06/26, documented the patient’s medications ordered by the physician were not consistently available and therefore not administered at various points during the 47-day review period as follow: -Potassium Chloride 20 milliequivalents (meq) oral packet: give 20meq every 8 hours via G tube (started 04/04/24) was recorded as not administered 21 times out of 21 doses. -Famotidine 40mg/5 milliliters (ml) (8mg/1ml) oral suspension: give 20mg two times a day via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Sodium Chloride 1 gram tablet: give 2 grams two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Dantrolene powder 20 milligrams (mg): two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Pyridoxine (VitaminB-6) 50mg: give 50mg one-time daily via G tube (started 04/04/24) was recorded as not administered 7 times out of 7 doses. -Furosemide 40mg/4ml oral solution: 16mg every 12 hours via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Senna 8.8mg/5ml oral syrup: 8.8mg two times daily via G tube (started 04/04/24) was recorded as not administered 14 times out of 14 doses. -Singulair 5mg tablet: give 5mg every day via G tube (started 04/04/24) was recorded as not administered 4 times out of 7 doses. -Spironolactone 25mg tablet: give 25mg every 12 hours via G tube (started 04/04/24) was recorded as not administered1 times out of 14 doses. Further review revealed the record lacked written evidence that the HHA promptly notified the relevant physician(s)/allowed practitioner(s) and obtained timely plan-of-care modification when ordered medication administration was not occurring. The review revealed that Patient #1 was sent to emergency room on 02/04/26 for scrotal edema and urinary retention. On 03/02/26 at 2:46PM, during an interview, the Director of Nursing (DON)/Clinical Manager stated she was not aware of Patient #1 not receiving his medications as ordered. The DON/Clinical Manager stated the patient’s medication administration records (MAR) are mailed to the office weekly for filing and that the MARs are not reviewed by anyone before being filed in the patient’s records. Review of the Clinical Manager job description effective 01/22/2024, read “The Clinical Manager is responsible for the clinical oversight of business lines, including clinical personnel oversight and management.” Review of the Home Health Agency’s policy titled, "Administration and Documentation of Medications" (4/11/2016, revised 10/6/2025) documents: Purpose: To provide guidelines for the safe administration of medications by licensed personnel. Procedure: -5.1 The nurse will provide instructions to the patient and/or family/caregiver regarding current medications on a continuing basis. The instructions will include medication administration... -5.4 Nurses will document medications administered on the Medication Administration Record. Only those medications that the nurse administers or oversees the administration of shall be documented on the Medication Administration Record. -5.5.2 Medications refused, removed, and/or omitted will be indicated on the Medication Administration Record, and with an explanation made in the medical record. The office clinical leader or clinical designee and attending physician will be notified. Review of the home health agency policy titled, “Care Coordination/Case Conference” (effective date 3/3/2011, revised 1/16/2026) documents: Purpose: To ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. To facilitate effective communication amongst the health care team. Policy: Care coordination is accomplished through communication with the members of the health care team. Procedure: Direct care staff shall communicate changes in patient status among the assigned personnel and the office clinical leader or clinical designee. Direct care staff will communicate changes in a timely manner via telephone, one-on-one meeting, case conferences, and/or home visits. Documentation of communications will be included in the medical record on a communication note, case conference note, clinical visit note, supervisory note, or in the system of record. Documentation will include: the date and time of the communication, individuals involved with the communication, information discussed, and the outcome of the communication.

An unannounced Complaint survey, #2025004629, was conducted on 04/29/2025 at Maxim Healthcare Services, Home Health Agency provider. The provider is not in compliance with Title 42 Code Of Federal Regulations (CFR) Part 484, Subpart A-C, Conditions of Participation for Home Health Agencies.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on review of the Home Health Agency (HHA)'s Handbook, record review and interview, the HHA failed to ensure that the patient’s representative was informed and agreed to the Plan of Care changes for 1 of 3 sampled patients reviewed as evidenced by the lack of written evidence that the patient’s representative was informed, participated and agreed with the reduction of the Skilled Nursing hours ((Patient #1). The findings included: Review of the HHA’s patient rights listed on the handbook provided on admission documents, “…Receive proper written notice, in advance, of a specific service being provided…of any reduction of termination of services…receive all services outlined in the plan of care and be informed, in advance, of any changes to the plan of care…”. Review of Patient #1s clinical record revealed a lack of written evidence regarding the patient’s ... (parent) being informed of and agreed to the Plan of Care changes. On 04/29/25 at 10:15 AM, an interview was conducted with the HHA Operations Manager (OM) who stated that at one point, Patient #1’s skilled nursing hours were reduced by the patient's Insurance provider from 24 hours 7 days a week to 16 hours 7 days a week and added the patient’s ... (parent) is currently going through appealing the hours. The OM was asked if the patient’s ... (parent) was informed (of the decrease in skilled nursing hours) then and stated that an employee told him that he called the ... (parent) but did not document it. The OM stated that on 03/21/25, a Multidisciplinary Team (MDT) meeting/clinical note documents that insurance (provider)’s Case and Senior Managers, patient’s ... (parent) and HHA's Clinical Manager were present in the meeting. The OP stated that during the meeting, staffing was addressed, and the Case Managers were told that the case was staffed. The meeting note documents that the insurance 9provider's) Case Manager asked the patient’s (parent) if ... (they) wanted another provider and stated ... (they) was happy with the HHA. The OM was asked if the reduction of skilled nursing hours was discussed during the meeting and stated he did not see any documentation about it. On 04/29/25 at 1:46 PM, during an interview, the OM stated that around April 2025 he got a call from the insurance (provider), informing that Patient #1 services were not medically necessary for the patient’s condition, and that the (skilled) nursing hours were going to be reduced from 24 hours to 16 hours. The OM stated the HHA received a letter from the patient’s insurance (provider) and the patient’s ... (parent) was told that they were not able to provide 24 hours until insurance approval. The OM stated the skilled nursing hours schedule was 7:00 AM to 7:00 PM and 7:00 PM to 11:00 PM for a total of 16 hours from 04/02/25 to 04/23/25. The OM stated that on 04/23/25, he received a call from the patient’s insurance (provider) to resume the 24 hours a day for 7 days and added this is a temporary authorization until the insurance (provider) reviews the appeal and makes a decision. The OM submitted a copy of the letter received from Patient #1’s insurance titled, “Notice of Adverse Benefit Determination” dated 02/23/25. The letter documents, “…we are approving 24 hours for 7 day a week until 03/31/2025. The private duty nursing hours will then be decreased. This is to 16 hours a day for 7 days a week…if you doctor wishes to discuss this decision…he/she can call (the insurance (provider) name) …within 2 (two) business days of this notification…” Review of Patient #1’s electronic clinic note dated 04/02/25 written by the OM documents, “spoke to patient’s parent ... (name) and informed that due to the partial denial of (Patient #1)'s authorization, services would need to be reduced to 16 hours/day beginning today. ... (parent's name) was unaware of the partial denial and was upset ... (they) was not informed by (HHA) earlier… stated ... (they) did not receive anything… will keep us informed of the appeal process…”. The OM was asked if there was any written documentation notifying Patient #1’s (parent) of the insurance (provider)'s decision decreasing the (skilled) nursing hours between 02/23/25 and 04/02/25 and he replied he could not find written documentation in the patient’s file.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on review of the Home Health Agency (HHA)'s Policy, record review and interview, the HHA failed to ensure that patient’s physician was notified of the Plan of Care changes for 1 of 3 sampled patients reviewed as evidenced by the lack of a written supplemental physician's order or a communication note to the physician notifying the physician of the reduction of the skilled nursing hours (Patient #1). The findings included: Review of the HHA’s Policy titled, “Plan of Care” revised on 01/17/25 documents, “…the patient/client or legal representative will participate in the development of the initial plan of care and any changes thereto. At a minimum, there is evidence in the patient/client record that the patient/client agrees to the plan of care and any changes to the pan of care…care/services will be provided according to the agreed to plan of care…if new or revised treatment goals are indicated, these changes are documented in the record and reflected in a subsequent plan of care documents…” Review of Patient #1’s clinical record documents a start of care date on 12/06/24. Review of the patient’s Home Health Certification and Plan of Care for the period from 04/09/2025 to 05/07/2025 documents physician's orders for discipline and treatments, Skilled Nursing Services 24 hours per day, seven days a week for 60 days. The Plan of Care incudes a Care Summary that documents, “…Patient #1 was seen for a routine recertification and supervisory visit on 03/25/25… (their parent) present …” On 04/29/25 at 10:15 AM, an interview was conducted with the HHA's Operations Manager (OM) who stated that at one point that Patient #1’s (skilled) nursing hours were reduced by the Insurance (provider) from 24 hours 7 days a week to 16 hours 7 days a week and added the patient’ ... (parent) is currently going through appealing the hours. The OM stated that on 03/21/25 a Multidisciplinary Team (MDT) meeting/clinical note documents that insurance (provider)’s Case and Senior Managers, patient’s ...(parent) and HHA's Clinical Manager were present in the meeting, added that the physician was not present. The OP stated during the meeting, staffing was addressed, and the Case Managers were told that the case was staffed. The meeting note documents that the insurance (provider)'s case manager asked the patient’s ... (parent) if ... (they) wanted another provider and stated ... (they) was happy with the HHA. The OM was asked if the reduction of skilled nursing hours was discussed during the meeting and stated he did not see any documentation about it. On 04/29/25 at 1:46 PM, during an interview, the OM stated that around April 2025 he got a call from the insurance (provider), informing that Patient #1's services were not medically necessary for the patient’s condition, and that the (skilled) nursing hours were going to be reduced from 24 hours to 16 hours. The OM stated the HHA received a letter from the patient’s insurance (provider) and the patient’s ... (parent) was told that they were not able to provide 24 hours until the insurance (provider's) approval. The OM stated the skilled nursing hours schedule was 7:00 AM to 7:00 PM and 7:00 PM to 11:00 PM for a total of 16 hours from 04/02/25 to 04/23/25. The OM stated that on 04/23/25, he received a call from the patient’s insurance (provider) to resume the 24 hours a day for 7 days and added this is a temporary authorization until the insurance (provider) reviews the appeal and makes a decision. The OM submitted a copy of the letter received from Patient #1’s insurance (provider) titled, “Notice of Adverse Benefit Determination” dated 02/23/25. The letter documents, “…we are approving 24 hours for 7 day a week until 03/31/2025. The private duty nursing hours will then be decreased. This is to 16 hours a day for 7 days a week…if you doctor wishes to discuss this decision…he/she can call ... (the insurance (provider's name) within 2 (two) business days of this notification…”. The OM was asked if the physician was notified of the skilled nursing hours reduction and replied that the insurance (provider) sent a letter to the physician. On 04/29/25 at 2:35 M, an interview and a side-by-side review of Patient #1’s certification Plan of Care from 04/09/25 to 05/07/25 was conducted with the OM. The OM was apprised that the Plan of Care's physician's orders documents Skilled Nursing Services 24 hours per day, seven days a week for 60 days. The OM stated he will look for a supplemental order from the physician. On 04/29/25 at 3:25 PM, the OM stated there was no supplemental physician's orders related to Patient #1’s reduction of the skilled nursing hours.

During the Health Recertification survey conducted from 04/15/2024 to 04/17/2024 at Maxim Healthcare Services, Home Health Agency provider, Emergency Preparedness was reviewed. The provider is in compliance with Emergency Preparedness per 42 Code of Federal Regulations (CFR) Part 484.102, Condition of Participation for Home Health Agencies.

An unannounced Recertification survey was commenced on 04/15/2024 and concluded on 04/17/2024 at Maxim Healthcare Services, Home Health Agency provider, located at 6301 N.W. 5th Way Suite 5010 Fort Lauderdale, FL 33309. The provider was not in compliance with 42 Code Of Federal Regulations (CFR) Part 484 Subpart A-C, Conditions of Participation for Home Health Agencies.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on review of the Home Health Agency (HHA)'s Policy, record review and interview, the HHA failed to ensure that their patients receive services as per the Physician's Plan of Care for 2 of 7 sampled patients (Patient #2 and #5). The findings included: 1) Review of the HHA's policy titled, “Missed Shift/Visit” revised on 04/09/21 documents, “…a missed shift occurs when the patient’s scheduled shift is not completed according to the practitioner order…” Review of Patient #2’s clinical record reveals a start of care on 01/26/21 with a Home Health Certification and Plan of Care (POC) dated 01/11/24 to 03/10/24 and 03/11/24 to 05/09/24. The patient’s diagnoses require the Home Health Agency's services. Review of the POC documents “Skilled Nursing services 24 hours per day, 7 days per week for 60 days…" Review of Patient#2’s clinical record documents "missed visits" on the following dates with a documented reason of “No Qualified Caregiver Available” for 11/06/23- 7:00 PM to 7:00 AM shift, 11/07/23- 7:00 PM to 7:00 AM shift, 11/11/23- 2:00 PM to 7:00 PM shift, 11/18/23- 7:00 AM to 7:00 PM shift, 11/20/23- 7:00 PM to 7:00 AM shift, 11/23/23- 7:00 AM to 7:00 PM shift, 11/25/23- 7:00 PM to 7:00 AM shift, 12/04/23- 7:00 PM to 7:00 AM shift, 12/05/23- 7:00 PM to 7:00 AM shift, 12/06/23- 7:00 PM to 7:00 AM shift, 12/09/23- 7:00 PM to 7:00 AM shift, 12/14/23- 7:00 PM to 7:00 AM shift, 12/16/23- 7:00 AM to 7:00 PM shift, 12/18/23- 7:00 PM to 7:00 AM shift, 12/19/23- 7:00 PM to 7:00 AM shift, 12/23/23- 7:00 AM to 7:00 PM shift, 12/30/23- 7:00 AM to 7:00 PM shift, 12/31/23- 7:00 PM to 7:00 AM shift, 01/01/24- 7:00 PM to 7:00 AM shift, 01/02/24- 7:00 PM to 7:00 AM shift, 01/06/24- 7:00 AM to 7:00 PM shift, 01/06/24- 7:00 PM to 7:00 AM shift, 01/13/24- 7:00 AM to 7:00 PM shift, 01/15/24- 7:00 AM to 7:00 PM shift, 01/15/24- 7:00 PM to 7:00 AM shift, 01/16/24- 7:00 PM to 7:00 AM shift, 01/20/24- 7:00 PM to 7:00 AM shift, 01/25/24- 7:00 PM to 7:00 AM shift, 01/29/24- 7:00 PM to 7:00 AM shift, 01/30/24- 7:00 PM to 7:00 AM shift, 02/12/24- 7:00 PM to 7:00 AM shift, 02/17/24- 7:00 PM to 7:00 AM shift, 03/02/24- 7:00 PM to 7:00 AM shift, 03/16/24- 7:00 PM to 7:00 AM shift, 03/22/24- 7:00 AM to 7:00 PM shift and 03/30/24- 7:00 PM to 7:00 AM shift. On 04/16/24 at 9:45 AM, an interview was conducted with the Clinical Manager who stated that the HHA's nurses are Per-Diem status and the HHA has been hiring but the nurses are continuously looking for better pay and leave. On 04/17/24 at 3:15 PM, an interview was conducted with the Administrator who stated that some of the missed shifts were because the nurse was not available to take a shift or had an emergency; the Administration was apprised that Patient #1 had many missed shifts due to “No Qualified Caregiver Available” and that the HHA must have staff available to cover the accepted patients and his/her needed services. On 04/17/24 at 3:30 PM, during an interview regarding Patient #2’s missed shift report, the Clinical Manager stated that on 12/04/23 the patient’s nurse called in to say that she was having emergency surgery and did not return until recently; the Clinical Manager stated the HHA did not have a replacement nurse and the nurses did not want to pick up anymore shifts; the Clinical Manager stated that she was not aware that the patient had many missed shifts and the HHA did not have a Performance Improvement Plan related to missed shifts. 2) Review of Patient #5’s clinical record reveals a start of care on 06/03/21 with a Home Health Certification and Plan of Care (POC) dated 09/21/23 to 11/19/23; 11/20/23 to 01/18/24 and 01/19/24 to 03/18/24. The patient’s diagnoses require the Home Health Agency's services. The POC documents, “Skilled Nursing services 24 hours per day, 7 days per week for 60 days…” Review of Patient #5’s clinical record documents "missed visits" on the following dates with a documented reason of, “No Qualified Caregiver Available” for 11/03/23- 7:00 AM to 7:00 PM shift, 11/04/23- 7:00 PM to 7:00 AM shift, 11/07/23- 7:00 PM to 7:00 AM shift, 11/11/23- 7:00 PM to 7:00 AM shift, 11/12/23- 7:00 AM to 7:00 PM shift, 11/14/23- 7:00 PM to 7:00 AM shift, 11/16/23- 7:00 PM to 7:00 AM shift, 11/19/23- 7:00 PM to 7:00 AM shift, 11/23/23- 7:00 PM to 7:00 AM shift, 11/28/23- 7:00 PM to 7:00 AM shift, 11/30/23- 7:00 PM to 7:00 AM shift, 12/04/23- 7:00 PM to 7:00 AM shift, 12/07/23- 7:00 PM to 7:00 AM shift, 12/04/23- 7:00 PM to 7:00 AM shift, 12/04/23- 7:00 PM to 7:00 AM shift, 12/10/23- 7:00 AM to 7:00 PM shift, 12/10/23- 7:00 PM to 7:00 AM shift, 12/13/23- 7:00 PM to 7:00 AM shift, 12/19/23- 7:00 PM to 7:00 AM shift, 12/22/23- 7:00 PM to 7:00 AM shift, 12/24/23- 7:00 PM to 7:00 AM shift, 12/25/23- 7:00 PM to 7:00 AM shift, 12/29/23- 7:00 AM to 7:00 PM shift, 12/29/23- 7:00 PM to 7:00 AM shift, 12/30/23- 7:00 PM to 7:00 AM shift, 12/31/23- 7:00 PM to 7:00 AM shift, 01/04/24- 7:00 PM to 7:00 AM shift, 01/09/24- 7:00 PM to 7:00 AM shift, 01/11/24- 7:00 PM to 7:00 AM shift, 01/12/24- 7:00 AM to 7:00 PM shift, 01/14/24- 7:00 AM to 7:00 PM shift, 01/17/24- 7:00 PM to 7:00 AM shift, 01/20/24- 7:00 PM to 7:00 AM shift, 01/24/24- 7:00 PM to 7:00 AM shift, 01/25/24- 7:00 PM to 7:00 AM shift and 01/30/24- 7:00 PM to 7:00 AM shift. On 04/17/24 at 3:17 PM, a side-by-side review of Patient #5’s "missed shifts" was conducted with the Clinical Manager who stated that it is hard to get night shift nurses and the HHA are constantly hiring nurses; stated the HHA did not have a replacement nurse and the nurses did not want to pick up anymore shifts; stated that she was not aware that the patient had many missed shifts and the HHA did not have a Performance Improvement Plan related to missed shifts.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review, interview and observation, the Home Health Agency failed to follow physicians' orders for drugs and treatments for 3 of 5 sampled patients (Patient #1, #2 and #3). The findings included: 1) Review of Patient #1’s clinical record reveals a start of care on 10/31/16 with a Home Health Certification and Plan of Care (POC) dated 11/24/23 to 01/22/24 and 03/23/24 to 05/21/24. The patient’s diagnoses require the Home Health Agency's services. The POC orders documents a Skilled Nurse once a week for 60 days, Skilled Nurse to notify the physician for: “…Systolic (upper number) Blood Pressure less than 90 or greater that 160 sustained for 5 minutes, Diastolic (lower number) Blood Pressure less than 55 or greater than 95 sustained for 5 minutes”. Review of Patient #1’s Comprehensive Assessment dated 04/10/24 lacks written evidence of the patient’s Blood Pressure reading. Review of the Skilled Nurse notes for Patient #1 for 01/05/24, 01/11/24, 01/17/24, 01/24/24, 02/01/24, 02/07/24, 02/21/24, 02/28/24, 03/06/24, 03/13/24, 03/21/24, 03/27/24, 04/03/24, and 04/10/24 reveals a lack of written documentation of the patient’s Blood Pressure readings for each visit, as per the physician's order. Observation and interview, on 04/17/24 at 11:11 AM, during a home visit to Patient #1, accompanied by Staff D, Registered Nurse (RN) and the HHA's Clinical Manager reveals Staff D took Patient #1’s temperature and did not check the patient's Blood Pressure; Patient #1 stated he was taking Losartan (medication) for Blood Pressure, but their pain increased and they were not taking any medication for Blood Pressure at this time and the patient stated he did not decline to have their Blood Pressure taken. On 04/17/24 at 12:05 PM, a joint interview was conducted with Staff D, RN and the HHA Clinical Manager who were apprised that Patient #1’s clinical record lacks written documentation of the patient's Blood Pressure every visit; Staff D stated that her Blood Pressure machine was broken; the Clinical Manager stated that she was not aware of that and Staff D should have checked the patient’s Blood Pressure every visit. 2) Review of Patient #2’s clinical record reveals a start of care on 01/26/21 with a Home Health Certification and Plan of Care (POC) dated 01/11/24 to 03/10/24 and 03/11/24 to 05/09/24. The patient’s diagnoses require the Home Health Agency's services. The POC documents “Skilled Nursing services 24 hours per day, 7 days per week for 60 days…medications: Saccharomyces Boulardii (probiotic) 250 mg. (milligrams), give 500 mg. every twelve hours via Gastrostomy Tube (G-Tube)…Gabapentin (for pain) 250 mg./5 ml. (milliliter), give 50 mg. three times daily via G-Tube, ok to increase to 75 mg. if pain is not controlled, or decreased to dose if patient is too sedated, Ozobax ( 5 mg/5 ml, give 15mg every six hours via G-Tube…”. Review of Patient #2’s medication profile provided by the Clinical Manager documents Saccharomyces Boulardii 250 mg, give 500 mg every twelve hours via Gastrostomy Tube (G-Tube), Gabapentin 250 mg/5 ml, give 50 mg three times daily via G-Tube, ok to increase to 75 mg if pain is not controlled, or decreased to dose if patient is too sedated and Ozobax (decrease spasms) 5 mg./5 ml., give 15mg every six hours via G-Tube as active/current medications. Review of Patient #2’s home medication administration record from the week of 02/25/24 through 04/13/24 documents the word, “discontinued” for Gabapentin 250 mg./5 ml., give 50 mg. three times daily via G-Tube, ok to increase to 75 mg. if pain is not controlled, or decreased to dose if patient is too sedated started on 10/11/23 and the word, “unavailable” for Saccharomyces Boulardii 250 mg., give 500 mg. every twelve hours via Gastrostomy Tube (G-Tube) started on 12/12/22. During an interview, on 04/16/24 at 11:51 AM, at a home visit to Patient #2, accompanied by Staff B, Licensed Practical Nurse (LPN) and the HHA's Clinical Manager, an interview was conducted with Staff B who stated she changed the patient’s diaper and added that the patient was not doing well and was having some spams. On 04/16/24 at 12:01 PM, medication administration for Patient #2 performed by Staff B that reveals Staff B retrieved a bottle of Baclofen (Ozobax) 5 milligrams per 5 millimeters (5mg/5ml); Staff B stated Patient #2 was scheduled for Baclofen (a medication for spams) at 12 noon; observation reveals Staff B retrieved one (1) millimeter of Baclofen and stated she needed 15 millimeters for a full dose; Staff B was not able to find another bottle of Baclofen in the patient’s home and stated the outgoing nurse did not report any issues with the medication or being out of it and Patient #2 was having spams and did not have the medication to treat the spams at the time of the home visit. On 04/16/24 at 12:15 PM, a side-by-side review of Patient #2’s current week Medication Administration Record (MAR) was conducted with Staff B that reveals the patient’s medications, Saccharomyces Boulardii 250 mg., give 500 mg. every twelve hours via Gastrostomy Tube (G-Tube) and Gabapentin 250 mg./5 ml., give 50 mg. three times daily via G-Tube were not documented as administered, as per physician orders; Staff B stated Saccharomyces Boulardii 250 mg. was not available for a while and Gabapentin was discontinued long ago. A side-by-side review of Patient #2’s Plan of Care for 03/11/24 to 05/09/24 was conducted with Staff B and the Clinical Manager to reveal an active/current physician's order for both medications. On 04/17/24 at 2:31 PM, an interview was conducted Staff E, RN/ Clinical Supervisor who stated she was responsible for patient’s "recertification" and goes out to see (visit) the patients and the Skilled Nurse every 60 days; Staff E stated she goes over all medications that the patient has in the home and is taking, and added that once the visit is done, she calls the physician for approval of continuation of care; Staff E stated they do four (4) attempts and have five (5) days to complete the POC; Staff E explained she does medication reconciliation with the family, the nurse and with the medication bottle and added that if the medication and bottle does not match, she calls the physician's office; Staff E was apprised of Patient #2 not being given Gabapentin and Saccharomyces Boulardii medications "for a while," according to Staff B and Staff E stated that she was not aware of that. On 04/17/24 at 3:30 PM, during an interview, the Clinical Manager stated she was not aware that Patient #2 was not getting Saccharomyces Boulardii 250 mg. as ordered by the physician. The Clinical Manager stated that the nurse informed her that the Gabapentin medication was discontinued, and the Home Health Agency’s office had called the physician’s office and had no response; the Clinical Manager was not able to provider written documentation regarding calling the physician’s office regarding Gabapentin or Saccharomyces Boulardii not being given as ordered. Consequently, a side-by-side review of Patient #2’s Plan of Care for 01/11/24 to 03/10/24 and 03/11/24 to 05/09/24 was conducted with the Clinical Manager who confirmed that Patient #2’s had an active/current physician order during both recertification periods for Saccharomyces Boulardii 250 mg., give 500 mg. every twelve hours via Gastrostomy Tube (G-Tube) and Gabapentin 250 mg./5 ml., give 50 mg. three times daily via G-Tube, ok to increase to 75 mg. if pain is not controlled, or decrease the dose if the patient is too sedated. 3) Review of Patient #3’s clinical record reveals a start of care on 02/22/22 with a Home Health Certification and Plan of Care (POC) dated 02/12/24 to 04/11/24 and 04/12/2024 to 06/10/2024. The patient’s diagnoses require the Home Health Agency's services. The POC documents a “Skilled Nurse daily for 60 days…vital signs: …. Blood Pressure each visit and as needed for changes in patient condition. Notify the physician for: …Systolic Blood Pressure less than 90 or greater that 160 sustained for 5 minutes, Diastolic Blood Pressure less than 55 or greater than 95 sustained for 5 minutes." Review of Patients #3’s Skilled Nurse (SN) notes for 02/05/24, 02/12/24, 02/21/24, 02/28/24, 03/04/2403/12/24, 03/21/24, 03/28/4, 04/11/24 and 04/13/24 reveals a lack of written documentation of the patient’s Blood Pressure readings. Further review of the Patient #3’s Comprehensive Assessment, dated 03/30/24 reveals a lack of written documentation of the patient's Blood Pressure reading. On 04/17/24 at 10:22 AM, during a home visit to Patient #3, accompanied by Staff D, Registered Nurse (RN) and the HHA Clinical Manager observation reveals that Staff D did not check Patient #3’s Blood Pressure during the visit. On 04/17/24 at 12:05 PM, an interview was conducted with Staff D, RN who stated that her Blood Pressure machine was broken. On 04/17/24 at 4:32 PM, during an interview, the Clinical Manager was apprised of Patient #3 physician's order for Blood Pressure checks every visit was not followed as ordered.

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on record review, observation and interview, the Home Health Agency (HHA) failed to ensure the patient’s plan of care documented current information for 2 of 5 sampled patients who received home visits as evidenced by interviews with the patients during a home visit who stated they were not taking the medications listed on the revised plan of care (Patient #1 and Patient #3). The findings included: 1) Review of Patient #1’s clinical record reveals a start of care on 10/31/16 with a Home Health Certification and Plan of Care (POC) dated 03/23/24 to 05/21/24. The patient’s diagnoses require the Home Health Agency's services. The POC documents a Skilled Nurse once a week for 60 days and the following medications were included: Colchicine 0.6 milligrams (mg.) every day (a medication for Gout); Mobic 7.5 mg. every day (a medication for pain) and Pravastatin 10 mg. every day (a medication for high cholesterol). Review of Patient #1’s clinical record documents their last Skilled Nursing Comprehensive Assessment was dated 04/10/24. Review of the patient’s "medication profile," provided by the Clinical Manager documents Colchicine 0.6 mg. every day, Mobic 7.5 mg. every day and Pravastatin 10 mg. every day as "active/current medications." On 04/17/24 at 11:11 AM, a home visit to Patient #1 accompanied by Staff D, Registered Nurse (RN) and the HHA Clinical Manager was conducted; on 04/17/24 at 11:45 AM, an interview and a review with Patient #1’s medications listed on the current POC and the medication profile was conducted; the patient stated that he is not taking Colchicine, did not recall the medication called Mobic and added that Pravastatin was causing pain and is not taking it; the patient did not remember when he stopped taking those medications and stated their physician is aware. On 04/17/24 at 11:55 PM, a side-by-side review of Patient #1’s POC was conducted with Staff D who stated she did the last "Comprehensive Assessment" and "recertification" not too long ago and did not know that the patient was not taking those medications listed on the POC. On 04/17/24 at 4:15 PM, during an interview, the Clinical Manager stated she did not have a physician's order to discontinue Patient #1’s Colchicine, Mobic and Pravastatin; the Clinical Manager stated that she obtained a medication list from the physician and then it is transcribed into the POC; the Clinical Manager was asked if the medication list was reviewed with the patient and stated the nurses are supposed to do that; the Clinical Manager stated she was responsible for creating the patient’s POC before it was sent out to the physician. 2) Review of Patient #3’s clinical record reveals a start of care on 02/22/22 with a Home Health Certification and Plan of Care (POC) dated 04/12/2024 to 06/10/2024. The patient’s diagnoses require the Home Health Agency's services. The POC documents a Skilled Nurse daily for 60 days and the following medications were included: Advair Diskus (prevent respiratory symptoms) 250 mcg. (micrograms)-50 mcg. /dose powder for inhalation every day; Bentyl (antispasmodic) 20 mg. twice a day; ASA (Aspirin) 81 mg. every day; Calcitrate (Calcium) 200 mg., take 950 mg. twice a day; Cymbalta (for pain) 60 mg. every day; Fluticasone (steroid) inhaler two times a day; Folic Acid (vitamin) 1 mg. every day; Lipitor (statin) 80 mg. at bedtime; Neurontin (for pain) 300 mg. three times a day; Protonix (decreases stomach acid) 40 mg. every day; Renvela (decreases blood phosphorus) 800 mg. three times a day; Rocatrol (for low calcium) 0.5 mg. twice a day; Roxicodone (pain) 5 mg. as needed and Zoloft (antidepressant) 50 mg. every day. Review of the patient’s medication profile provided by the Clinical Manager documents the listed medications as active/current medications. Review of Patient #3’s clinical record documents the patient's last Skilled Nursing Comprehensive Assessment was dated 03/30/24. On 04/17/24 at 10:22 AM, a home visit to Patient #3 accompanied by Staff D, Registered Nurse (RN) and the HHA Clinical Manager was conducted. On 04/17/24 at 10:35 AM, an interview and a review with Patient #3’s medications listed on their current POC and the medication profile was conducted; the patient stated that she is not taking Advair Diskus 250 mcg.-50 mcg./dose powder for inhalation every day, ASA 81 mg. every day, Calcitrate 200 mg., take 950 mg. twice a day, Cymbalta 60 mg. every day, Fluticasone inhaler two times a day, Folic Acid 1 mg. every day, Lipitor 80 mg. at bedtime, Neurontin 300 mg. three times a day, Protonix 40 mg. every day, Renvela 800 mg. three times a day, Rocatrol 0.5 mg. twice a day, Roxicodone 5 mg. as needed, and Zoloft 50 mg. every day; the patient stated she is taking Bentyl 20 mg. twice a day as needed and had a new prescription for Rabeprazole (Prilosec) which was filled on 04/11/24; during the review, Patient #3 stated she feels better not taking those medications. On 04/17/24 at 10:55 AM, a joint interview was conducted with Staff D, RN and the Clinical Manager. The Clinical Manager stated that Patient #3 has many physicians and the Home Health Agency is not getting calls back from the physicians to review her medications; the Clinical Manager stated she was responsible of creating the patient’s POC before it was sent out to the physician.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on review of the Home Health Agency’s Policy, observation, record review and interview, the Home Health Agency (HHA) failed to maintain infection control measures to prevent potential cross contamination during the wound care observation for 1 of 1 sampled patients during a home visit for wound care. (Patient #1). The findings included: Review of the HHA's Policy titled, “Wound Care” revised on 04/09/21 documents, “…all wound care shall be provided using clean technique…infection control measures shall be followed…" Review of the HHA's Policy titled, “Bag Technique” revised on 04/21/11 documents, “...place a barrier...on a flat surface before setting bag down..." Review of Patient #1’s clinical record reveals a start of care on 10/31/16 with a Home Health Certification and Plan of Care (POC) dated 03/23/24 to 05/21/24. The patient’s diagnoses require the Home Health Agency's services. The POC documents a Skilled Nurse once a week for 60 days for wound care as to cleanse wounds to the Right and Left feet with soap and water, apply Silver Stat (antibacterial), cover with a foam dressing and secure with kerlix (gauze wrap) and tape, weekly. On 04/17/24 at 11:11 AM, a home visit to Patient #1 accompanied by Staff D, Registered Nurse (RN) and the HHA Clinical Manager was conducted. On 04/17/24 at 11:31 AM, observation reveals Staff D placed her nursing bag and her clipboard on top of the patient’s bed blanket without placing a barrier; Staff D performed hand hygiene, donned gloves, gathered the wound supplies, cleaned Patient #1’s right foot wound with a gauze soaked with soap and water and with her gloved hand, reached to her pocket and retrieved her cellular phone; further observation reveals Staff D, without changing gloves, proceeded to apply Silver Stat ointment to the patient’s right foot wounds; further observation reveals Staff D continued to wear the same pair of gloves and proceeded to clean Patient #1’s left wound. On 04/17/24 at 12:05 PM, a joint interview was conducted with Staff D, RN and the HHA Clinical Manager; Staff D was asked when she would change gloves during the patient's wound care and stated that she will change her gloves in between (wound care); Staff D and the Clinical Manager were apprised that she did not change gloves during Patient #1’s right foot and left foot wound care; Staff D stated she should have changed gloves and the Clinical Manager stated she should have changed gloves after cleaning the wounds. During the interview, on 04/17/24 at 12:05 PM, Staff D was asked about placing her nursing bag and her clipboard on top of the patient’s bed without a barrier; Staff D stated that she did not know she had to, and the Clinical Manager acknowledged that Staff D did not place a barrier and should have done so.

An unannounced Complaint survey, #2022009445 was commenced on 09/13/2022 and concluded on 09/30/2022 at Maxim Healthcare Services, Home Health Agency provider. The provider is not in compliance with 42 CFR Part 484, Subpart A-C, Conditions of Participation for Home Health Agencies. One Condition Level Deficiency was identified to be out of compliance: 42 CFR Part 484.60- Care Planning, Coordination of Care, Quality of Care (G0570). Six Standard Level Deficiencies were identified to be out of compliance: 42 CFR Part 484.50(e)(1)(i)(B)-Mistreatment Neglect Or Abuse (G0482): 42 CFR Part 484.60 (b)(1)- Only As Ordered By The Physician (G0580); 42 CFR Part 484.60(d)-Coordination Of Care (G0600); 42 CFR Part 484.60(d)(1)- Communication With All Physicians (G0602); 42 CFR Part 484.60(d)(2)- Integrate All Orders (G0604) and 42 CFR Part 484.60(d)(3)-Integrate All Services (G0606). The cumulative effect of these systemic practices resulted in the Home Health Agency’s inability to ensure that their patients’ nursing needs would be met.

Mistreatment, neglect or abuse CFR(s): 484.50(e)(1)(i)(B) (i)(B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on review of the Home Health Agency (HHA)'s Policies and Procedures, record review and interview, it was determined that the HHA's staff failed to provide care and services necessary for 1 of 3 patients as evidenced by the patient's Occupational Therapist, the patient's Respiratory Therapist and the HHA's staff, who were furnishing services to the patient, placed the patient, who has a tracheostomy, face down on their abdomen for approximately 54 minutes, without a physician's order, and without Oxygen Therapy and monitoring of the patient's Blood Oxygen Saturation levels, as the physician ordered (Patient #1). The findings included: Review of the HHA's Policy and Procedure, provided by the Clinical Manager titled, “Abuse, Neglect, or Exploitation” revised on 04/09/21 documented “ …definitions: …child abuse, neglect…any act of omission or commission that endangers or impairs the child’s physical…health…this includes medical care neglect…neglect: failure of a caretaker to supply the patient with the necessary…health care or supervision for a patient…”. Review of Patient #1’s record documented an initial start of care on 01/18/19, a resumption of care on 03/05/21, status post heart surgery and a transfer to the hospital on 05/05/21. The patient’s diagnoses included Acute Respiratory Failure with Hypoxia (lack of oxygen), Necrotizing Enterocolitis in newborn, Pulmonary Hypertension, Tracheostomy Status, Gastrostomy Status, Low Birth Weight Newborn, Disorders of the White Blood Cells, Acute Embolism and Thrombosis of Vein, Myotonic Muscular Dystrophy, Feeding Difficulties, Acute Infarction of Spinal Cord, and Quadriplegia. Review of Patient #1’s physician's Plan of Care (POC), with a certification period from 03/08/21 to 05/06/21 documented the following orders: -Full code (meaning patient to be resuscitated if cardiac or respiratory arrest occurs). -Skilled Nursing: 23 hours per day 7 days a week; 1 RN (Registered Nurse) visit per day. -Oxygen liter: 0-5 liters as needed ten times max (maximum) tracheal oxygen prn (as needed) to keep (Oxygen) saturation above 92%. -Skilled Nursing Assessment: Skilled Nursing to complete a head to toe and pain assessment each shift and as needed for any changes in patient condition. Report all adverse changes to the physician/RN Supervisor/Caregiver. -Skilled Nurse to instruct/perform/supervise Home Care Exercise program and adaptive/self-care techniques when indicated. -Oximeter: Obtain Oxygen saturation every shift and as needed for signs and symptoms of respiratory distress. -Pulse Oximetry to be on continuously. -Maintain Oxygen saturation greater than or equal to 92%. -Skilled Nurse to assess/monitor/instruct patient/caregiver in Pulse Oximetry and notify MD (physician) if readings are below 92%. The POC (Plan Of Care) care summary documented that Patient #1 tolerated being off the ventilator but required supplemental Oxygen due to heart defect…requires Skilled Nursing for tracheostomy/ventilator dependence…Oxygen management…has not had any ER (Emergency Room) visits or hospitalization in the last 60 days…patient’s airway will remain patent, will remain free of complications associated with respiratory treatments/equipment and will demonstrate adequate gas exchange throughout the certification period…” Review of the POC lacks documented evidence of a physician's order for Patient #1’s “Tummy Time” as treatment to be provided in the home. Review of Patient #’1's additional supplemental physician orders for certification period from 03/08/21 to 05/06/21 provided by the HHA Clinical Manager, lacks documented evidence of a physician's order for “Tummy Time." On 09/13/22 at 3:56 PM, a telephone interview was conducted with Staff A, a Licensed Practical Nurse (LPN), who stated that her shift was from 7:00 AM to 7:00 PM; Staff A stated that Patient #1 had a tracheostomy and was off the ventilator during the day; stated that the patient 's Pulse Oximeter machine was malfunctioning and she used her own personal “finger” type "pulse meter" to check Patient #1’s Oxygen Saturation; Staff A stated the patient was receiving Respiratory Therapist (RT) services, maybe 4 (four) days a week, and added she was not sure of the days; Staff A stated that from time to time she would put Patient #1 on “Tummy Time” as directed by the patient's Physical or Occupational therapist; Staff A was asked to explain what she meant by “Tummy Time” and she explained that the patient was put on their abdomen/face down for about 10-15 minutes; Staff A was asked if she had a physician's order for "Tummy Time" and stated that the therapists were in charge of that; Staff A stated that on their last visit to the patient, 05/05/21, Patient #1’s Respiratory Therapist came to the patient’s home and while he was treating the patient with CPT (Chest Physical Therapy), he told her that the patient was not responding and "was not looking good;" Staff A stated CPR (Cardiopulmonary Resuscitation) was started and EMS (Emergency Medical System) was activated, 911 was called. Staff A stated she did not recall which position Patient #1 was in when she was notified by Staff D, RT that the patient "did not look good" and added that had been a year and a half ago. On 09/14/22 at 8:49 AM, a side-by-side review of Patient #1’s record was conducted with the HHA's Clinical Manager (CM) that revealed the patient’s last Pediatric Comprehensive Assessment was completed on 04/15/21 and the patient had a tracheostomy at the time of the assessment; the CM stated that the patient’s POC certification period from 03/08/21 to 05/06/21 did not include an order from any of Patient #1’s physician for “Tummy Time;" the CM was asked if she had seen patients with tracheostomy on “Tummy Time” and replied that she honestly had not seen patients with a tracheostomy on "Tummy time;" the CM stated she had seen patients without a tracheostomy with a physician's order for "Tummy Time;" she was asked if she has seen patients with a tracheostomy having a physician's order for "Tummy Time" and replied, “No, I would be worried about that with a trach (tracheostomy) patient; the CM stated that “Tummy Time” has to be on the patient's POC;" the CM stated there was not a physician's order for "Tummy Time" for Patient #1; the CM was asked if she was aware of Oxygen equipment issues for Patient #1 and stated that was not aware of any Oxygen equipment issues in the home; the CM was asked for documentation related to Oxygen equipment malfunctioning (Pulse Oximeter) and stated she did not see any documentation related to any issues with the equipment. On 09/14/22 at 11:55 PM, a telephone interview was conducted with Staff B, who stated that she was Patient #1’s Registered Nurse/Case Manager(RN-CM); Staff B, RN stated that her role was to make sure the nurses were following the POC; Staff B was asked if there was any issues with the patients Pulse Oximetry equipment probe and stated that there was a couple of times they have to get a new probe or monitor and added that she did not recall which one; Staff B stated that Patient #1 had a Pulse Oximetry probe connected to their toe/foot at all times and the nurses were supposed to rotate it and Staff B stated the patients Oxygen equipment was accessible next to the patient. On 09/14/22 at 4:42 PM, an interview was conducted with the Home Health Agency (HHA) Clinical Manager (CM); the CM was apprised that during a telephone interview on 09/13/22 with Staff A, Staff A stated that from time to time she was placing Patient #1 on their tummy as per the patient’s Physical Therapist (PT) instructions to her and that the patient’s Pulse Oximetry was malfunctioning; the CM confirmed that there was no physician's order for Patient #1 to be put on their tummy. On 09/16/22 at 12:54 PM, a second telephone interview was conducted with Staff A, who stated that the therapist will do "Tummy Times "for Patient #1 and that the doctor (physician) was aware of that; Staff A was apprised that there was no physician's order for "Tummy Time" for Patient #1. On 09/21/22 at 2:16 PM, a telephone interview was conducted with the HHA's Clinical Manager who stated that the HHA did not have any videos in the patient's record, but that they had an understanding that there was a camera in the patient's home. Review of Patient #1’s provided camera/videos dated 05/05/21 revealed the following: At 7:06 AM, the video revealed Staff A, conversing with a female in the patient's area. The video audio revealed that Staff A said, “he gave her more” and pointed to a bag hanging a pole next to the patient with a light brownish colored liquid. The patient chest was moving up and down with short and swallow breaths. At 8:04 AM, the video revealed Staff A, placing Patient #1 in a sitting position, removing her clothes and then reaching to a machine above the patient's head of the bed and pressing on the screen. At 8:05 AM, the video revealed Staff A, was removing the patient's gown, completed, checks on the patient’s chest tubing. There was not a visible Pulse Oximeter probe on the patient's hands. Patient #1 was moving their head side-to-side fast and their chest was moving up and down with short and shallow breaths. At 8:08 AM, the video revealed Staff A, undoing Patient #1’s diaper, the diaper that had dark fecal material on it. Staff A lifted both of the patient's legs up towards the ceiling. There was no visible Pulse Oximetry probe on the patient's toes. At 8:13 AM , the video revealed Patient #1 lying in bed on their back, uncovered. The patient’s chest and abdominal muscles were noted to move up and down. At 8:17 AM, the video revealed Staff A , dressing the patient. The patient’s eyes were open and their chest was moving up and down, no distress noted. At 8:47 AM, the video revealed Patient #1 moving their head side-to-side swiftly, chest moving up and down with short and shallow breaths. The video revealed Staff A, pulling a white cord connected to the machine located above the patient's head of the bed and from underneath the patient. Staff A was not seen connecting the cord to the patient. At 9:02 AM, the video revealed Staff C, Occupational Therapist (OT) identified by Staff A, on her "Nursing Flow Sheet, enters Patient #1’s area. The patient was lying on their left side and their chest was moving up and down with short and shallow breaths. No respiratory distress noted. At 9:03 AM, the video revealed Staff C, OT, holding the patient’s face, talking to the patient. The patient’s chest was moving up and down and the patient's eyes were open directed to the OT. At 9:06 AM, the video revealed Staff C, OT picking up Patient #1 from a lying position in the middle of the bed to the foot of the bed. From 9:07 AM to 9:21 AM the video camera did not capture the patient or Staff C. At 9:22 AM, the video revealed Staff C, OT holding the patient by the neck and providing head support, patient placed in sitting position in the bed then on their back and then on their left side. At 9:23 AM, the video revealed Staff C, OT lifting Patient #1’s right arm and moving it up and down. At 9:25 AM, the video revealed Staff C, OT moving patient's right hand up to the patients face. There was not a visible Pulse Oximetry noted at the patient's right hand. At 9:39 AM, the video revealed Staff A, pushing Patient #1 over their right side. The patient's eyes and mouth were open, the patient's tongue was pink. The patient's chest was moving up and down. At 9:41 AM, the video revealed Staff C, OT lifting the patient's left arm. There was not a visible Pulse Oximetry noted at the patient's right hand. At 9:42 AM, the video revealed Staff C, OT suctioning the patient via a suction closed system. The video revealed Patient #1 mouth open and vomiting a moderate amount of light-yellow secretions. Staff C did not notice the patient vomited. At 9:43 AM, the video revealed Staff C, OT continued to perform patient's left arm exercises, then stops. Patient continues to have vomit secretions in their mouth from 9:43 to 9:46 AM. At 9:46 AM, the video revealed Staff C, OT looking over the patient's side and states, “... (Patient’s name) vomited” The video audio revealed Staff A states, “You throw up” and added “she threw up yesterday too”. At 9:50 AM, the video audio revealed Staff A, states, “that was not a spit up, that was a throw up." At 9:51 AM, the video revealed Staff C, OT suctioning the patient via a suction closed system. At 9:53 AM, the video revealed Staff A, with what it appears to be a large travel pillow, covers it with a pillowcase and then placing it at the patient's head of the bed. The video revealed then Staff C, OT placing Patient #1 on top of the travel pillow with the patient's arms over the pillow and facing down (on their stomach), patient's legs were bent at the knee level. The patient was wearing what appears to be sneaker shoes with splint like apparatus. Further review revealed that the patient did not have a Pulse Oximetry probe on their feet or hands. Staff C continues to reposition the patient's head and legs placing the patient’s knees in a bending position. At 9:54 AM, the video revealed Staff A, suctioning the patient via a closed suction system. At 9:54 AM, the video revealed Patient #1 moving their left hand and Staff C, OT repositioning the patient's head and states, “Are you comfy? Staff C then moves the patient's left arm in. The video revealed a blanket was placed under the patient's bottom. The video audio revealed Staff A, stating, “I’m gonna give you 10 minutes of these until undo the knee part”. At 9:55 AM, the video revealed Patient #1 moving their head, and back up and down. Staff C, OT video audio revealed, “... (Patients name) I like this position…she looks big…” The video audio revealed Staff A, states, “I do too, I can do her hair”. The audio revealed Staff C states, .. (patients father’s name) …you think? The video audio revealed a male voice that states ,“Look at you." At 9:55 AM, the video revealed Staff C, OT leaving the patient. Patient #1’s skin color was pink, and the patient's back was moving up and down with short shallow strokes. The video audio revealed Staff A, states, “You’re trying to get off your knees big girl, you look so good." At 9:57 AM, the video revealed Patient #1 continues facing down, knees in a bending position and audible breaths noted. At 9:58 AM, , the video revealed Patient #1 continues facing down and knees in a bending position and moving her back and her head in an up and down movement. The patient’s breathing pattern was noted to be with more effort than previously noted. At 9:59 AM, the video revealed Staff A, combing the patient’s hair. Patient #1 continues facing down and knees in a bending position. The patient’s back was moving up and down and faster than previously. At 10:08 AM, the video revealed Patient #1 continues facing down and knees in a bending position. The patient was moving her head and back in an up and down movement. The patient’s back movement expansion was less that previously. At 10:09 AM, the video revealed, Patient #1 continues facing down and the knees in a bending position. The video audio revealed Staff A, states, “…you got nothing to look at and you’re not comfortable, right?”. The video revealed Staff A attempting to place an I-Pad in front of the patient. Staff A did not assess the patient's tracheostomy for proper placement or the patient's respiratory status after the patient was placed on a face down and knees bending position at 9:53 AM. At 10:10 AM, the video revealed Patient #1 continues facing down and the knees in a bending position. The patient was moving her head up and down. The patient’s back muscles were noted with shallow movement up and down. At 10:11 AM, the video revealed Patient #1 continues facing down and the knees in a bending position. The patient was moving her head up and down and her back was barely moving up and down. The video revealed Staff A, positioning an I-Pad located in front of the patient. The video did not reveal Staff A, assessing the patient’s breathing or position. On 05/05/21 from 10:12 AM through 10:19 AM, the video revealed that Patient #1’s was barely moving her head and back. The video revealed Staff A, was in the patient's area having a conversation with Staff D, RT. At 10:19 AM, the video revealed Patient #1 continues facing down, the knees in a bending position. The patient’s back/thorax was barely moving. The video revealed Staff D, a Respiratory Therapist (RT), identified by Staff A on her "Nursing Flow Sheet, enters the patient’s area. The video revealed Staff D, RT placing a device on top of Patient #1’s bed and then leaves the patient's area. At 10:20 AM, the video revealed Patient #1 continues facing down, the knees in a bending position. The patient’s back/thorax was barely moving. The video revealed Staff D, RT returns to the patient's area, donning gloves, and without assessing the patient's respiratory status, starts to pound on the patient's back with the device. The video revealed the patient’s head of the bed been lowered. The video audio revealed Staff D states, “Put it a little lower." Patient #1 was noted hardly moving her head and thorax. On 05/05/21 from 10:20 AM through 10:25 AM, the video revealed Staff D, RT pounding Patient #1’s back. The video did not show Staff D performing any type of respiratory assessment for Patient #1 during the treatment. At 10:25 AM, the video revealed Patient #1's back/thorax not moving. The patient's head movement appears to have a gasping for air movement. Staff D, RT continues to do pounding strokes on the patient's back. At 10:27 AM, the video revealed Patient #1 back/thorax not moving. The patient's head movement continues to appear to have a gasping for air movement. The video revealed Staff D, RT briefly stops pounding strokes on the patient's back, then resumes the pounding strokes without assessing the patient’s respiratory status. At 10:28 AM, the video revealed Patient #1 back/thorax and her head not moving. Staff D, RT continues to do pounding strokes on the patient's back with brief stops. On 05/05/21 from 10:28 AM through 10:43 AM, the video revealed Patient #1 head, back/thorax was not moving and Staff D, RT continues to do pounding strokes on the patient's back with brief stops. The video revealed Staff D continues treatment without assessing the patient's respiratory status during the treatment. At 10:44 AM, the video revealed Staff D, RT looking at Patient #1 and then stops pounding on the patient’s back. The video revealed Patient #1 head, back/thorax was not moving. The video revealed Staff D moved away from the patient’s bedside. At 10:45 AM, the video revealed Staff D, RT returns to the patient's area and positions his back towards Patient #1’s bedside. The video audio revealed a conversation between Staff A and Staff D, RT. The video revealed Patient #1 head, back/thorax was not moving. At 10:46 AM, the video revealed Patient #1 head, back/thorax was not moving. The video revealed Staff D, RT at the patient’s bedside and picking up Patient #1 up from her face down, knees bent position. Staff D turns the patient around, facing him and places the patient in bed on her back. The video revealed Staff D shaking the patient's face and moving the patient’s left arm, patient did not respond. The video revealed Staff D pulling the patient’s tracheostomy gauze. The video revealed Patient #1’s eyes were closed, mouth was open, patient was not breathing. The patient’s forehead, tongue and thighs were purple in color. The video revealed Staff A, removing the patient’s blouse, bringing the patient to a sitting position. The video audio revealed Staff A shouting the patient's name out loud. The video revealed Staff A, LPN performing pounding strokes on the patient’s back with her hand. At 10:47 AM, the video revealed Staff D, RT standing next to the patient and Staff A, performing respiratory resuscitation with an "ambu bag" (a manual resuscitator) to Patient #1. Patient’s lungs were expanding with the manual resuscitator action. At 10:47 AM, the video revealed Staff D, RT next to the patient’s bedside, bending forward, a sound like a machine (an Oxygen Concentrator machine noise) that was turned on, was heard and Staff D returned to upright position. At 10:48 AM, the video revealed Staff D, RT performing manual resuscitation with the "ambu bag" and touching a machine above Patient #1’s head of the bed. The video audio revealed Staff A, states, “Pulse Oximetry not attached to her." The video audio captured another voice that states, “Is on the floor." The video revealed Staff D, RT performing manual resuscitation with the "ambu bag." Continued video revealed Patient #1’s left hand purple in color and Staff A, placing a Pulse Oximetry probe on the patient's left hand. The video audio revealed Staff A states, “Her hands are cold” and Staff A covering the patient's hands with her hands. Patient #1 was not responding to cardiopulmonary resuscitation. At 10:51 AM, the video audio revealed ,“911 what is the emergency”. The video audio revealed Staff A, stating, “the patient was on tummy time when turned over she was not responding, Staff D, RT started chest compression…"ambu (bag)" connected, chest not coming up." On 05/05/21 from 10:47 AM to 10:57 AM, the video revealed Patient #1 was given manual resuscitation until paramedics arrived at 10:57 AM.

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 record review, review of the Home Health Agency's Policies and Procedures and interview, the Home Health Agency failed to: Ensure that the physician's orders were followed (G0580); Ensure coordination of care related to the patient's Physical, Occupatinal and Respiratory Therapy services provided in the home (G0600); Ensure communication amongst all physicians involved in the patient's care (G0602); Ensure the integration of all the physicians' orders (G0604) and Ensure the integration of all services provided to the patient (G0606). The cumulative effect of these systemic practices resulted in the agency’s inability to ensure that the patients’ needs would be met.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the Home Health Agency (HHA) failed to follow the physician's orders for 1 of 3 sampled patients as evidenced by placing a patient with a tracheostomy, face down on their abdomen for approximately 54 minutes, without a physician's order, and without Oxygen Therapy and monitoring of the patient's Blood Oxygen Saturation levels, as the physician ordered (Patient #1). The findings included: Review of Patient #1’s record documentation reveals an initial start of care on 01/18/19, a resumption of care on 03/05/21 status post heart surgery and a transfer to the hospital on 05/05/21. The patient’s diagnoses included Acute Respiratory Failure with Hypoxia (lack of oxygen), Necrotizing Enterocolitis in newborn, Pulmonary Hypertension, Tracheostomy Status, Gastrostomy Status, Low birth weight newborn, Disorders of the White Blood Cells, Acute Embolism and Thrombosis of Vein, Myotonic Muscular Dystrophy, Feeding Difficulties, Acute Infarction of Spinal Cord, and Quadriplegia. Review of Patient #1’s physician Plan of Care (POC) certification period from 03/08/21 to 05/06/21 documented the following orders: -Full code (meaning patient to be resuscitated if cardiac or respiratory arrest occurs). -Skilled Nursing: 23 hours per day 7 days a week; 1 RN (Registered Nurse) visit per day. -Oxygen liter: 0-5 liters as needed ten times max (maximum) tracheal oxygen prn (as needed) to keep (Oxygen) saturation above 92%. -Skilled Nursing Assessment: Skilled Nursing to complete a head to toe and pain assessment each shift and as needed for any changes in patient condition. Report all adverse changes to the physician/RN Supervisor/Caregiver. -Skilled Nurse to instruct/perform/supervise Home Care Exercise program and adaptive/self-care techniques when indicated. -Oximeter: Obtain Oxygen saturation every shift and as needed for signs and symptoms of respiratory distress. -Pulse Oximetry to be on continuously. -Maintain Oxygen saturation greater than or equal to 92%. -Skilled Nurse to assess/monitor/instruct patient/caregiver in pulse oximetry and notify MD if readings are below 92%. MD (physician) if readings are below 92%. The POC care summary documented that Patient #1 tolerated being off the ventilator but required supplemental Oxygen due to heart defect…requires Skilled Nursing for tracheostomy/ventilator dependence…Oxygen management…has not had any ER (Emergency Room) visits or hospitalization in the last 60 days…patient’s airway will remain patent, will remain free of complications associated with respiratory treatments/equipment and will demonstrate adequate gas exchange throughout the certification period…” Review of the POC lack documented evidence of a physician order for Patient #1’s “Tummy Time” as treatment to be provided in the home. Review of Patient #’1's additional supplemental physician orders for certification period from 03/08/21 to 05/06/21 provided by the HHA Clinical Manager, lacks documented evidence of a physician's order for “Tummy Time." On 09/13/22 at 3:56 PM, a telephone interview was conducted with Staff A, a Licensed Practical Nurse (LPN), who stated that her shift was from 7:00 AM to 7:00 PM; Staff A stated that Patient #1 had a tracheostomy and was off the ventilator during the day; stated that the patient 's Pulse Oximeter machine was malfunctioning and she used her own personal “finger” type "pulse meter" to check Patient #1’s Oxygen Saturation; Staff A stated the patient was receiving Respiratory Therapist (RT) services, maybe 4 (four) days a week, and added she was not sure of the days; Staff A stated that from time to time she would put Patient #1 on “Tummy Time” as directed by the patient's Physical or Occupational therapist; Staff A was asked to explain what she meant by “Tummy Time” and she explained that the patient was put on their abdomen/face down for about 10-15 minutes; Staff A was asked if she had a physician's order for "Tummy Time" and stated that the therapists were in charge of that; Staff A stated that on their last visit to the patient, 05/05/21, Patient #1’s Respiratory Therapist came to the patient’s home and while he was treating the patient with CPT (Chest Physical Therapy), he told her that the patient was not responding and "was not looking good;" Staff A stated CPR (Cardiopulmonary Resuscitation) was started and EMS (Emergency Medical System) was activated, 911 was called. Staff A stated she did not recall which position Patient #1 was in when she was notified by Staff D, RT that the patient "did not look good" and added that had been a year and a half ago. On 09/14/22 at 8:49 AM, a side-by-side review of Patient #1’s record was conducted with the HHA's Clinical Manager (CM) that revealed the patient’s last Pediatric Comprehensive Assessment was completed on 04/15/21 and the patient had a tracheostomy at the time of the assessment; the CM stated that the patient’s POC certification period from 03/08/21 to 05/06/21 did not include an order from any of Patient #1’s physician for “Tummy Time;" the CM was asked if she had seen patients with tracheostomy on “Tummy Time” and replied that she honestly had not seen patients with a tracheostomy on "Tummy time;" the CM stated she had seen patients without a tracheostomy with a physician's order for "Tummy Time;" she was asked if she has seen patients with a tracheostomy having a physician's order for "Tummy Time" and replied, “No, I will be worried about that with a trach (tracheostomy) patient; the CM stated that “Tummy Time” has to be on the patient's POC;" the CM stated there was not a physician's order for "Tummy Time" for Patient #1; the CM was asked if she was aware of Oxygen equipment issues for Patient #1 and stated that was not aware of any Oxygen equipment issues in the home; the CM was asked for documentation related to Oxygen equipment malfunctioning (Pulse Oximeter) and stated she did not see any documentation related to any issues with the equipment. On 09/14/22 at 11:55 PM, a telephone interview was conducted with Staff B, who stated that she was Patient #1’s Registered Nurse/Case Manager(RN-CM); Staff B, RN stated that her role was to make sure the nurses were following the POC; Staff B was asked if there was any issues with the patients Pulse Oximetry equipment probe and stated that there was a couple of times they have to get a new probe or monitor and added that she did not recall which one; Staff B stated that Patient #1 had a Pulse Oximetry probe connected to their toe/foot at all times and the nurses were supposed to rotate it On 09/14/22 at 4:42 PM, an interview was conducted with the Home Health Agency (HHA) Clinical Manager (CM). The CM was apprised that during a telephone interview on 09/13/22 with Staff A, LPN, Staff A stated that from time to time she was placing Patient #1 on her tummy as per the patient’s Physical Therapist (PT) instructions to her and that the patient’s pulse oximetry was malfunctioning. The CM confirmed that there was not a physician's order for Patient #1 to be put on her tummy. On 09/16/22 at 12:54 PM, a second telephone interview was conducted with Staff A, LPN who stated that the therapist will do "Tummy Times "for Patient #1 and that the doctor (physician) was aware of that; Staff A was apprised that there was not a physician's order for "Tummy Time" for Patient #1. On 09/21/22 at 2:16 PM, a telephone interview was conducted with the HHA's Clinical Manager who stated that the HHA did not have any videos in the patient's record, but that they had an understanding that there was a camera in the patient's home. Review of Patient #1’s provided camera/videos dated 05/05/21 revealed the following: Review of Patient #’1’s home video dated 05/05/21 and timed 9:53 AM, the video revealed Staff A, LPN with what it appears to be a large travel pillow, covers it with a pillowcase and then placing it at the patient's head of the bed. The video revealed then Staff C, OT placing Patient #1 on top of the travel pillow with the patient's arms over the pillow and facing down (on their stomach), patient's legs were bent at the knee level. The patient was wearing what appears to be sneaker shoes with splint like apparatus. Further review revealed that the patient did not have a Pulse Oximetry probe on their feet or hands. Staff C continues to reposition the patient's head and legs placing the patient’s knee in a bending position. Review of Patient #’1’s home video dated 05/05/21 and timed 10:48 AM, revealed Staff D, RT performing manual resuscitation with the "ambu bag" and touching a machine above Patient #1’s head of the bed. The video audio revealed Staff A, LPN states, “pulse oximetry not attached to her”. The video audio captured another voice that states “Is on the floor”. The video revealed Staff D, RT performing manual resuscitation with the "ambu bag." Continued video revealed Patient #1’s left hand purple in color and Staff A, LPN placing a Pulse Oximetry probe on the patient's left hand. The video audio revealed Staff A states, “her hands are cold” and Staff A covering the patient's hands with her hands. Patient #1 was not responding to cardiopulmonary resuscitation and 911 was called.

Coordination of Care CFR(s): 484.60(d) Standard: Coordination of care. The HHA must: This STANDARD is not met as evidenced by: Based on review of the Home Health Agency (HHA)'s Policies and Procedures, record review and interview, it was determined that the HHA failed to coordinate the care delivery for 1 of 3 sampled patients as evidenced by the lack of coordination of care for the Occupational and Respiratory Therapy services provided to the patient (Patient #1). The findings included: Review of the HHA's Policy and Procedure provided by the HHA Clinical Manager (CM) titled, “Care Coordination/Case Conference revised on 07/01/22 documents, “To ensure the coordination of services for each patient and to minimize the potential for missed, conflicting or duplicated services…to facilitate effective communication amongst the health care team…”. Review of Patient #1’s record documented an initial start of care on 01/18/19, a resumption of care on 03/05/21, status post heart surgery and a transfer to the hospital on 05/05/21. The patient’s diagnoses included Acute Respiratory Failure with Hypoxia (lack of oxygen), Necrotizing Enterocolitis in newborn, Pulmonary Hypertension, Tracheostomy Status, Gastrostomy Status, Low Birth Weight Newborn, Disorders of the White Blood Cells, Acute Embolism and Thrombosis of Vein, Myotonic Muscular Dystrophy, Feeding Difficulties, Acute Infarction of Spinal Cord, and Quadriplegia. Review of Patient #1’s physician's Plan of Care (POC) for the certification period from 03/08/21 to 05/06/21 lacks evidence of coordination of care delivery by Respiratory, Physical Or Occupational Therapy provided in the patient's home. Review of Patient #’1 "Care Coordination Messages List," from 02/12/21 to 05/05/21 provided by the HHA's Clinical Manager, lack documented evidence of care coordination related to Respiratory, Physical and Occupational Therapy provided in the home. Review of Patient #’1 additional supplemental physician orders for certification period from 03/08/21 to 05/06/21 provided by the HHA's Clinical Manager, lacks documented evidence of a physician's order for Respiratory, Physical and Occupational Therapy to be provided in the home and lacks documented evidence of a physician's order for “Tummy Time." On 09/13/22 at 1:14 PM, during an interview, the HHA's Operations Manager stated he had been the Manager at the HHA since 2018; stated he has not had a contract with any Therapist, like Physical Therapy (PT), Occupational Therapy (OT) or Respiratory Therapy (RT) since he has been the manager; the HHA's operation Manager was asked who would arrange for Respiratory Therapy for those patients on ventilators or who have a tracheostomy and he stated that the family or the hospital Social Worker will assist with finding the Therapist for them and added that the HHA can’t recommend an "agency" to the family. On 09/13/22 at 3:56 PM, a telephone interview was conducted with Staff A, a Licensed Practical Nurse (LPN). Staff A stated that her shift was from 7:00 AM to 7:00 PM; Staff A stated that Patient #1 had a tracheostomy and was off the ventilator during the day; stated that the patient was receiving Respiratory Therapy visits maybe 4 (four) days a week and added she was not sure of the days; stated that from time to time she will put Patient #1 on “Tummy Time” as directed by the patient's Physical or Occupational Therapists; Staff A was asked to explain what she meant by “Tummy Time” and she explained that the patient was put on her abdomen/face down for about 10-15 minutes; Staff A was asked if she had a physician's order for "Tummy Time" and stated that the Therapists were in charge of that; Staff A further stated that on her last visit to the patient (05/05/21), Patient #1’s Respiratory Therapist came to the patient’s home. On 09/14/22 at 8:49 AM, a side by side review of Patient #1’s record was conducted with the HHA's Clinical Manager (CM) that revealed the patient’s last pediatric Comprehensive Assessment was completed on 04/15/21; the patient had a tracheostomy at the time of the assessment and the patient’s POC certification period from 03/08/21 to 05/06/21 documented this finding. During the review, and interview, on 09/14/22 at 8:49 AM, an inquiry was made regarding the patient’s POC and a physician's order for, “SN to refer to PT/OT/ST and RT to eval. (evaluate) and treat as needed;" the CM stated that he HHA had "nothing to do" with the PT/OT/ST and RT and added it "comes automatically" when the patient's POC is generated; the CM added that patient’s pulmonologist was probably the one who arranged RT for the patient; the CM stated that the nurses will follow the patients' pulmonologist's orders; a side-by-side with the CM of Patient #1’s pulmonologist's orders revealed orders for tracheostomy suctioning, Oxygen liter flow and Oxygen saturation dated 09/2019 and the CM stated there was no physician's order from any of Patient #1’s physicians for “Tummy Time." On 09/14/22 at 11:55 PM, a telephone interview was conducted with Staff B, who stated that she was Patient #1’s Registered Nurse/Case Manager(RN-CM); stated that she was aware that the patient was receiving Physical, Occupational and Respiratory therapy, but did not know or recall the name of their agencies and added that it has been so long (ago).

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on review of the Home Health Agency (HHA)'s Policies and Procedures, record review and interview, it was determined that the Home Health Agency (HHA) failed to communicate with all of the patient’s physicians for 1 of 3 sampled patients as evidenced by the lack of communication amongst the persons providing care and services to the HHA's patient including Occupational and Respiratory Therapists; as evidenced by the lack of communication with the patient’s Pulmonologist to inform the physician that the patient had “Tummy Time” and as evidenced by the lack of communication with the patient’s Gastroenterologist regarding the patient being fed food other than the food ordered by the patient's primary physician (Patient #1). The findings included: Review of the HHA's Policy and Procedure, provided by the Clinical Manager titled, “Care Coordination/Case Conference” revised on 07/01/22 documented, “to ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services…to facilitate communication amongst the health care team… care coordination is accomplished through communication with the members of the health care team including independent contractors where applicable…." Review of Patient #1’s record documented an initial start of care on 01/18/19, a resumption of care on 03/05/21, status post heart surgery and a transfer to the hospital on 05/05/21. The patient’s diagnoses included Acute Respiratory Failure with Hypoxia (lack of oxygen), Necrotizing Enterocolitis in newborn, Pulmonary Hypertension, Tracheostomy Status, Gastrostomy Status, Low Birth Weight Newborn, Disorders of the White Blood Cells, Acute Embolism and Thrombosis of Vein, Myotonic Muscular Dystrophy, Feeding Difficulties, Acute Infarction of Spinal Cord, and Quadriplegia. Review of Patient #1’s physician Plan of Care (POC) certification period from 03/08/21 to 05/06/21 documented the following orders: -Skilled Nursing: 23 hours per day 7 days a week; 1 RN (Registered Nurse) visit per day… -Oxygen liter: 0-5 liters as needed ten times max tracheal oxygen prn (as needed) to keep saturation above 92%. -Skilled Nursing Assessment: Skilled Nursing to complete a head to toe and pain assessment each shift and as needed for any changes in patient condition. Report all adverse changes to the physician/RN (Registered Nurse) Supervisor/Caregiver. -Skilled Nurse to refer to PT/OT/ST/RT (Physical Therapist, Occupational Therapist, Speech Therapist, Respiratory Therapist) to evaluate and treat as needed. Skilled Nurse to instruct/perform/supervise Home Care Exercise program and adaptive/self-care techniques when indicated. -Skilled Nurse to instruct/perform/supervise Home Care Exercise program and adaptive/self-care techniques when indicated. -Enteral feedings Neocate 20 kcal per ounce. Give 8 millimeters per hour. -Skilled Nurse to assess/monitor/instruct Pt (Patient)/Caregiver understanding of prescribed fluid intake….report abnormalities to the MD (Physician). Review of Patient #1’s POC and the HHA's communication messages lack documented evidence of communication with all of Patient #1’s physicians to include the Pulmonologist regarding “Tummy Time” as a treatment to be provided in the home. Review of the POC and the HHA 's "Communication Messages" lack documented evidence of communication with all of Patient #1’s physician's to include the patient's Gastroenterologist, related to patient’s family administering “Bone Broth” to the patient via tube feeding. On 09/13/22 at 3:56 PM, a telephone interview was conducted with Staff A, a Licensed Practical Nurse (LPN); Staff A stated that her shift was from 7:00 AM to 7:00 PM.; stated that Patient #1 had a tracheostomy and was off the ventilator during the day; stated that on 05/05/21, the patient's Pulse Oximeter machine was malfunctioning and she used her own personal "“finger” type pulse meter to check Patient #1’s blood Oxygen saturation level; stated that the patient was receiving Respiratory Therapist (RT) home visits maybe 4 (four) days a week, and added she was not sure of the days; stated that from time to time she will put Patient #1 on “Tummy Time” as directed by the patient's Physical or Occupational therapists; Staff A was asked to explain what she meant by “Tummy Time” and she explained that the patient was put on her abdomen/face down for about 10-15 minutes; Staff A was asked if she had a physician's order for "Tummy Time" and stated that the therapists were "in charge of that;" Staff A stated that on her last visit to the patient (05/05/21), Patient #1’s Respiratory Therapist came to the patient’s home and while he was treating the patient with CPT (Chest Physical Therapy), he told her that the patient was not responding and was "not looking good." Staff A stated CPR (Cardio-pulmonary Resuscitation) was started and EMS (Emergency Medical System) was activated, 911 was called; Staff A, stated she did not recall which position Patient #1 was in when she was notified by Staff D, RT (Respiratory Therapist) that the patient "did not look good" and added it had been over a year since this happened; Staff A stated that the patient’s father was giving bone broth to the patient via the tube feeding and Staff A added that the GI (Gastroenterologist) doctor was aware. On 09/14/22 at 8:49 AM, a side-by-side review of Patient #1’s record was conducted with the HHA Clinical Manager (CM) that revealed the patient’s last Pediatric Comprehensive Assessment was completed on 04/15/21 and the patient had a tracheostomy and a feeding tube at the time of the assessment; review of Staff A's, LPN (Licensed Practical Nurse) "Nursing Flow Sheet," dated 05/05/21 documented under comments, “dad give broth per conversation with GI…”; the CM stated there was no documented communication with the patient’s GI doctor related to the patient receiving bone broth by the family; the CM confirmed that there was no documentation related to communication with Patient’s #1’s Pulmonologist related to having “Tummy Time." On 09/14/22 at 11:55 PM, a telephone interview was conducted with Staff B, who stated that she was Patient #1’s Registered Nurse/Case Manager(RN-CM); Staff B, RN stated that her role was to make sure the nurses were following the POC; Staff B was asked if there was any issues with the patient's Pulse Oximetry equipment probe and stated that there was a couple of times they had to get a new probe or monitor and added that she did not recall which one; Staff B stated that Patient #1 had a Pulse Oximetry Probe connected to her toe/foot at all times and the nurses were supposed to rotate it. On 09/14/22 at 4:42 PM, an interview was conducted with the Home Health Agency (HHA)'s Clinical Manager (CM); the CM was apprised that during a telephone interview on 09/13/22 with Staff A, LPN, Staff A stated that from time to time she was placing Patient #1 on her tummy as per the patient’s Physical Therapist (PT) instructions to her and that the patient’s Pulse Oximetry was malfunctioning; the CM confirmed that there was no evidence of communication with the patient's physician related to the Pulse Oximetry malfunctioning. On 09/16/22 at 12:54, a telephone interview was conducted with Staff A, who stated that the therapist will do "Tummy Time" for Patient #1 and that the physician was aware of that; Staff A was apprised that there was no physician's order for "Tummy Time" for Patient #1. On 09/21/22 at 2:16 PM, a telephone interview was conducted with the HHA's Clinical Manager who stated that the HHA did not have any videos in the patient's record, but that they had an understanding that there was a camera in the patient's home. Review of Patient #1’s provided camera/videos dated 05/05/21 and timed 7:06 AM revealed Staff A, conversing with a female in the patient’s area (unable to understand them speaking). The video audio revealed that Staff A said, “he gave her more” and pointed to a bag hanging a pole next to the patient with a light brownish colored liquid. The patient chest was moving up and down with short and swallow breaths. Review of Patient #1's provided camera/videos dated 05/05/21 and timed from 9:53 AM to 10:47 AM revealed the patient was lying over a large travel pillow face down with the legs bending at the knees.

Integrate all orders CFR(s): 484.60(d)(2) Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient. This ELEMENT is not met as evidenced by: Based record review and interview, it was determined that the Home Health Agency (HHA) failed to integrate all of the physician's orders for 1of 3 sampled patients as evidenced by the lack of documentation related to the type, frequency and duration of the patient's Physical, Occupational and Respiratory Therapy services being provided in the patient's home and the HHA failed to integrate the patient's Gastroenterologist (GI)'s orders into the patient's Plan Of Care) POC as evidenced by the patient being fed food not documented the POC (Patient #1). The findings included: Review of Patient #1’s record documented an initial start of care on 01/18/19, a resumption of care on 03/05/21, status post heart surgery and a transfer to the hospital on 05/05/21. The patient’s diagnoses included Acute Respiratory Failure with Hypoxia (lack of oxygen), Necrotizing Enterocolitis in newborn, Pulmonary Hypertension, Tracheostomy Status, Gastrostomy Status, Low Birth Weight Newborn, Disorders of the White Blood Cells, Acute Embolism and Thrombosis of Vein, Myotonic Muscular Dystrophy, Feeding Difficulties, Acute Infarction of Spinal Cord, and Quadriplegia. Review of Patient #1’s physician Plan of Care (POC) for the certification period from 03/08/21 to 05/06/21 documented the following orders: -Skilled Nursing: 23 hours per day 7 days a week; 1 RN (Registered Nurse) visit per day… -Oxygen liter: 0-5 liters as needed ten times max tracheal Oxygen prn (as needed) to keep saturation above 92%. -Skilled Nursing Assessment: Skilled Nursing to complete a head to toe and pain assessment each shift and as needed for any changes in patient condition. Report all adverse changes to the physician/RN Supervisor/Caregiver. -Skilled Nurse to refer to PT/OT/ST/RT (Physical Therapist, Occupational Therapist, Speech Therapist, Respiratory Therapist) to evaluate and treat as needed. Skilled Nurse to instruct/perform/supervise Home Care Exercise program and adaptive/self-care techniques when indicated. -Enteral feedings- Neocate 20 k-calorie per ounce. Give 8 millimeters (ml) per hour continuously. Review of Patient #1’s POC lacks documented evidence of the type, frequency and duration of the patient's Physical, Occupational or Respiratory Therapy orders as part of the patient's POC; the patient's record lacks evidence of integrating the patient's GI orders and care into the patient's POC. On 09/13/22 at 3:56 PM, a telephone interview was conducted with Staff A, a Licensed Practical Nurse (LPN) who stated that her shift was from 7:00 AM to 7:00 PM; stated that Patient #1 had a tracheostomy and was off the ventilator during the day; Staff A stated the patient was receiving a Respiratory Therapist (RT) visits maybe 4 (four) days a week, and added she was not sure of the days; stated that from time to time she will put Patient #1 on “Tummy Time” as directed by the patient's Physical or Occupational therapists; Staff A was asked to explain what she meant by “Tummy Time” and she explained that the patient was put on her abdomen/face down for about 10-15 minute; Staff A was asked if she had a physician's order for "Tummy Time" and stated that the therapists were in charge of that; Staff A stated that on her last visit to the patient (05/05/21), Patient #1’s Respiratory Therapist came to the patient’s home and while he was treating the patient with CPT (Chest Physical Therapy), he told her that the patient was not responding and "was not looking good;" Staff A stated CPR (Cardiopulmonary Resuscitation) was started and EMS (Emergency Medical System) was activated, 911 was called; Staff A, stated that she did not recall which position Patient #1 was in when she was notified by Staff D, RT (Respiratory Therapist) that the patient "did not look good" and added it had been over a year since this happened; Staff A stated that the patient’s father was giving bone broth to the patient via the tube feeding; Staff A added that the patient's GI (Gastroenterologist) physician was aware. On 09/14/22 at 8:49 AM, during an interview and a side-by-side review of Patient #1’s record conducted with the HHA Clinical Manager (CM) revealed the patient’s last Pediatric Comprehensive Assessment was completed on 04/15/21 and the patient had a tracheostomy and a feeding tube at the time of the assessment; review of Staff A's "Nursing Flow Sheet," dated 05/05/21 documented under comments, “dad give broth per conversation with GI…;" the CM stated there was no documented communication with the patient’s GI physician related to patient receiving bone broth by the family; the CM confirmed that there was no evidence of documentation related to communication with Patient’s #1’s Pulmonologist related to having “Tummy Time." On 09/14/22 at 11:55 PM, a telephone interview was conducted with Staff B, who stated that she was Patient #1’s Registered Nurse/Case Manager(RN-CM); stated that she was aware that the patient was receiving Physical, Occupational and Respiratory Therapy, but did not know or recall the name of their "agencies" and added it has been so long (ago). On 09/14/22 at 4:42 PM, an interview was conducted with the HHA's Clinical Manager (CM) who was was apprised that during a telephone interview on 09/13/22 with Staff A, Staff A stated that from time to time she was placing Patient #1 on her tummy as per the patient’s Physical Therapist (PT) instructions to her and that the patient’s Pulse Oximetry was malfunctioning; the CM confirmed that there was no evidence of documentation of communication with the patient's physician or their office related to the Pulse Oximetry malfunctioning. On 09/16/22 at 12:54, a telephone interview was conducted with Staff A, who stated that the therapist will do "Tummy Times" for Patient #1 and that the physician was aware of that; Staff A was apprised that there was no physician's order for "Tummy Time" for Patient #1. On 09/21/22 at 2:16 PM, a telephone interview was conducted with the HHA's Clinical Manager who stated that the HHA did not have any videos in the patient's record, but that the HHA had an understanding that there was a camera in the home. Review of Patient #1’s provided camera/videos dated 05/05/21 and timed 7:06 AM revealed Staff A, LPN conversing with a female in the patient’s area (unable to understand them speaking). The video audio revealed that Staff A said, “he gave her more” and pointed to a bag hanging a pole next to the patient with a light brownish colored liquid. The patient's chest was moving up and down with short and swallow breaths. Review of Patient #1's provided camera/videos dated 05/05/21 and timed from 9:53 AM to 10:47 AM revealed the patient was lying over a large travel pillow face down with the legs bending at the knees.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on interview and record review, it was determined that the Home Health Agency (HHA) failed to integrate all services for 1of 3 sampled patients as evidenced by the lack of documentation of the frequency, duration and type of therapy provided by the patient's Physical, Occupational and Respiratory Therapists to the patient and the HHA failed to integrate the patient's GI (Gastroenterologist)'s orders into the patient's Plan Of Care (POC) as evidenced by Patient #1 being fed with food not documented on the POC (Patient #1) The findings included: Review of Patient #1’s record documented an initial start of care on 01/18/19, a resumption of care on 03/05/21, status post heart surgery and a transfer to the hospital on 05/05/21. The patient’s diagnoses included Acute Respiratory Failure with Hypoxia (lack of oxygen), Necrotizing Enterocolitis in newborn, Pulmonary Hypertension, Tracheostomy Status, Gastrostomy Status, Low Birth Weight Newborn, Disorders of the White Blood Cells, Acute Embolism and Thrombosis of Vein, Myotonic Muscular Dystrophy, Feeding Difficulties, Acute Infarction of Spinal Cord, and Quadriplegia. Review of Patient #1’s physician Plan of Care (POC) certification period from 03/08/21 to 05/06/21 documented the following orders: -Skilled Nursing: 23 hours per day 7 days a week; 1 RN (Registered Nurse) visit per day. -Oxygen liter: 0-5 liters as needed ten times max (maximum) tracheal oxygen prn (as needed) to keep (Oxygen) saturation above 92%. -Skilled Nursing Assessment: Skilled Nursing to complete a head to toe and pain assessment each shift and as needed for any changes in patient condition. Report all adverse changes to the physician/RN Supervisor/Caregiver. -Skilled Nurse to refer to PT/OT/ST/RT (Physical Therapist, Occupational Therapist, Speech Therapist, Respiratory Therapist) to evaluate and treat as needed. Skilled Nurse to instruct/perform/supervise home care exercise program and adaptive/self-care techniques when indicated. -Enteral feedings- Neocate 20 k-calorie per ounce. Give 8 millimeters (ml) per hour continuously. Review of Patient #1’s POC lacks documented evidence of the Physical, Occupational or Respiratory Therapy orders as part of the patient's POC. The patient's record lacks evidence of integrating the patients GI orders and care into the patients POC. On 09/13/22 at 3:56 PM, a telephone interview was conducted with Staff A, a Licensed Practical Nurse (LPN) who stated that her shift was from 7:00 AM to 7:00 PM; Staff A stated that Patient #1 had a tracheostomy and was off the ventilator during the day; stated the patient was receiving Respiratory Therapist (RT) visits may be 4 (four) days a week, and added she was not sure of the days; stated that from time to time she would put Patient #1 on “Tummy Time” as directed by the patient's Physical or Occupational therapists; Staff A was asked to explain what she meant by “Tummy Time” and she explained that the patient was put on her abdomen/face down for about 10-15 minutes; Staff A was asked if she had a physician's order for "Tummy Time" and stated that the Therapists were in charge of that; Staff A stated that on her last visit to the patient (05/05/21), Patient #1’s Respiratory Therapist came to the patient’s home and while he was treating the patient with CPT (Chest Physical Therapy), he told her that the patient was not responding and was "not looking good;" Staff A stated CPR (Cardiopulmonary Resuscitation) was started and EMS (Emergency Medical System) was activated, 911 was called; Staff A, stated she did not recall which position Patient #1 was in when she was notified by Staff D, RT that the patient "did not look good" and added it had been over a year since this happened; Staff A stated that the patient’s father was giving "bone broth" to the patient via the tube feeding and added that the GI (Gastroenterologist) was aware. On 09/14/22 at 8:49 AM, a side-by-side review of Patient #1’s record was conducted with the HHA's Clinical Manager (CM) that revealed the patient’s last Pediatric Comprehensive Assessment was completed on 04/15/21 and the patient had a tracheostomy and a feeding tube at the time of the assessment; review of Staff A's "LPN Nursing Flow Sheet," dated 05/05/21 documented under comments, “Dad gave broth per conversation with GI…;" the CM stated that this was not documented as a communication with the patient’s GI related to the patient receiving bone broth by the family; the CM confirmed that there was no documentation related to communication with Patient’s #1’s Pulmonologist related to having “Tummy Time." On 09/14/22 at 11:55 PM, a telephone interview was conducted with Staff B, who stated that she was Patient #1’s Registered Nurse/Case Manager(RN-CM); stated that she was aware that the patient was receiving Physical, Occupational and Respiratory therapy, but did not know or recall the name of their agencies and added it has been so long (ago). On 09/14/22 at 4:42 PM, an interview was conducted with the HHA Clinical Manager (CM) who was apprised that during a telephone interview on 09/13/22 with Staff A, Staff A stated that from time to time she was placing Patient #1 on her tummy as per the patient’s Physical Therapist instructions to her; the CM confirmed that there was no communication documented with the patient's physician or the HHA, related to patient having “Tummy Time." On 09/16/22 at 12:54, a telephone interview was conducted with Staff A, who stated that the therapist will do "tummy times "for Patient #1 and that the physician was aware of that; Staff A stated that she did not know if there was a physician's order for patient to have “Tummy Time.” On 09/21/22 at 2:16 PM, a telephone interview was conducted with the HHA's Clinical Manager who stated that the HHA did not have any videos in the patient's record, but that the HHA had an understanding that there was a camera in the home. Review of Patient #1’s provided camera/videos dated 05/05/21 and timed 7:06 AM revealed Staff A, conversing with a female in the patient’s area (unable to understand them speaking). The video audio revealed that Staff A said, “he gave her more” and pointed to a bag hanging on a pole next to the patient with a light brownish colored liquid. The patient's chest was moving up and down with short and swallow breaths. Review of Patient #1’s provided camera/videos dated 05/05/21 and timed 9:02 AM revealed Staff C, Occupational Therapist (OT) identified by Staff A, on her "Nursing Flow Sheet, enters Patient #1’s area. The patient was lying on her left side and her chest was moving up and down with short and shallow breaths. No respiratory distress noted. At 9:06 AM, the video revealed Staff C, OT picking up Patient #1 from a lying position in the middle of the bed to the foot of the bed. From 9:07 AM to 9:21 AM the video camera did not capture the patient or Staff C. At 9:53 AM, the video revealed Staff A, with what it appears to be a large travel pillow, covers it with a pillow case and then placing it at the patient's head of the bed. The video revealed then Staff C, OT placing Patient #1 on top of the travel pillow with the patient's arms over the pillow and facing down (on her stomach), patients legs were bent at the knee level. At 9:55 AM, the video revealed Staff C, OT leaving the patient. Patient #1’s skin color was pink, and the patient's back was moving up and down with short shallow strokes. Review of Patient #1’s provided camera/videos dated 05/05/21 and timed 10:19 AM revealed Patient #1 continues facing down, the knees bent. The patient’s back/thorax was barely moving. The video revealed Staff D, a Respiratory Therapist (RT), identified by Staff A on her "Nursing Flow Sheet, enters the patient’s area. The video revealed Staff D, RT placing a device on top of Patient #1’s bed and leaving the patient's area. At 10:20 AM, the video revealed Patient #1 continues facing down, the knees bent. The patient’s back/thorax was barely moving. The video revealed Staff D, RT returns to the patient's area, donning gloves, and without assessing the patient's respiratory status, starts to pound on the patient's back with the device. The video revealed the patient’s head of the bed had been lowered. The video audio revealed Staff D states, “Put it a little lower." Patient #1 was noted hardly moving her head and thorax.

During the Recertification survey conducted on 06/08/21 through 06/10/21 at Maxim Healthcare Services, a Home Health Agency provider, Emergency Preparedness was reviewed. Maxim Healthcare Services is in compliance with Emergency Preparedness per Code of Federal Regulations (CFR) 42, Part 484.102, Condition of Participation for Home Health Agencies.

An unannounced Recertification and Focused Infection Control survey was completed on 06/08/21 to 06/10/21 at Maxim Healthcare Services, Home Health Agency provider. The provider was not in compliance with Code of Federal Regulations (CFR) 42, Part 484, Subpart A-C, Conditions of Participation for Home Health Agencies.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the Home Health Agency failed to timely coordinate with the pharmacy and/or physician services regarding IV antibiotic dosing that required laboratory monitoring and to timely notify the physician of missed visits and missed antibiotic dosages for 1 of 8 sampled patients (Patient #1). Review of Patient #1's Hospital Discharge Summary dated 01/20/21 documents diagnoses that require Home Health Agency services. Review of the initial Plan of Care documents Patient #1 started care on 01/21/21 and required Skilled Nurse visits for wound care, IV (Intravenous) Vancomycin (antibiotic) administration twice daily and blood samples for Vancomycin "trough" (lowest level of a drug before the next dose) levels on Mondays and Thursdays. Continued review reveals that Patient #1’s Start of Care was on Thursday, 01/21/21 and the patient received 2 Skilled Nurse visits that day; however, there was no evidence of documentation that the blood Vancomycin level was drawn as ordered or that the nurse obtained clarification from the physician not to draw the blood Vancomycin level that first day. Patient #1's laboratory result with fax date and time of 01/25/21 at 2:24 PM documents the Vancomycin trough level on 01/25/21 was "high" at 19.6 ug/ml (micrograms per milliliter), (the reference range for a therapeutic level is 10.0 – 15.0 ug/ml) and the note, “Toxic: trough Vancomycin concentrations greater than 20 may be associated with the onset of nephrotoxicity (toxicity to the kidneys)" and "Patient drug level exceeds published reference range. Evaluate clinically for signs of potential toxicity." The laboratory results from 01/25/21 also document Patient #1's BUN (Blood Urea Nitrogen) level was normal at 19 mg/dL (milligrams per deciliter), (reference range is 8-27 mg/dL) and Creatinine was high at 1.56 mg/dL (reference range is 0.76-1.27 mg/dL). BUN and creatinine are indicators of kidney function. There was no evidence that these laboratory results were sent or communicated to the pharmacy or of follow up with the physician to obtain further directions until the afternoon of 01/26/21, after 2 more Vancomycin doses had been given to Patient #1 on the evening of 01/25/21 and the morning of 01/26/21. A Clinical Note Entry on 01/26/21 for 2:32 PM documents laboratory results were faxed to the pharmacy and physician's office. However, there was no evidence of documentation of further attempts to communicate with the physician or pharmacy about the high levels of Vancomycin before administering a further 4 doses of Vancomycin to Patient #1 on the evening of 01/26/21, morning and evening of 01/27/21, and the morning of 01/28/21. Patient #1's laboratory result with fax date and time of 01/28/21 at 12:10 PM documents the Vancomycin trough level on 01/28/21 was 45.2 (reference 10.0 – 15.0) with an "Alert" flag: "Trough Vancomycin concentrations greater than 20 may be associated with the onset of nephrotoxicity," and documents, "Patient drug level exceeds published reference range. Evaluate clinically for signs of potential toxicity." Continued review reveals a total of six doses had been given without evidence of physician or pharmacy clarification/direction since the initial high level of Vancomycin. A “Clinical Note Entry,” on 01/28/21 documents a physician’s “verbal order” was received on 01/28/21 at 1:21 PM to “hold Patient #1's Vancomycin, not to give it unless otherwise directed by that physician, and to draw a Vancomycin level and BMP (Basic Metabolic Panel) on Saturday morning (01/30/21). No further Vancomycin was documented as given. Continued review reveals Patient #1's laboratory results on 01/30/21 (Saturday) document the Vancomycin level was still high at 31.3 and BUN and Creatinine levels had increased above normal to 31 (reference 8-27 mg/dL) and 3.77 mg/dL (reference 0.76-1.27 mg/dL), respectively. Patient #1's laboratory results on 02/01/21 (Monday) document the Vancomycin level was 17.9 ug/mL, and the BUN and Creatinine levels had further increased to 32 and 4.06, respectively. Review of a "Care Coordination Note" for 02/01/21 documents communication with the physician's office regarding "Saturday's lab results" and requesting the Home Health Agency’s help to contact the patient to tell them to go to the hospital immediately. A Transfer Summary for 02/01/21 documents Patient #1 was transferred to the hospital for “abnormal lab results.” During interview on 06/10/21 beginning at 2:30 PM, the Director of Clinical Services (DCS) stated the nurse would ask her for the Vancomycin level and she would text her the result, "just the number." The DCS said it was frustrating when you know something should be stopped, but you need an order to stop it and cannot get one; during this interview, the DCS stated she remembered getting a call from the Infusion Company (Pharmacy) on a Friday night notifying her that they talked to the physician and wanted Patient #1 sent to the hospital, and that the doctor and Infusion Company "arranged for" Patient #1 to go to the hospital but the patient did not go. The DCS said the nurse drew and they received new laboratory results on Saturday (the next day), which were also faxed to the physician's office and, although the physician's office was closed over the weekend, they would have seen them Monday morning. The DCS said there was nothing that needed to be done since the Vancomycin was already on hold and Vancomycin levels were decreasing and did not answer whether she was aware of the rising BUN and Creatinine levels or any other abnormal laboratory values. During telephone interview with Patient #1's nurse, Staff "A" on 06/11/21 at 12:30 PM, she explained laboratory results with the Vancomycin levels are faxed by the laboratory to the Home Health Agency’s office and physician, then the office faxes them to the pharmacy and re-faxes them to the physician's office. Staff "A" stated, during the interview, on 06/11/21 at 12:30 PM that the Director of Clinical Services (DCS) calls to let her know of "changes”, but she does not receive/see the laboratory results or reference ranges and only knows what the DCS tells her. Staff "A" denied being told of the "Alert" on Patient #1's laboratory reports from 01/25/21 or 01/28/21 to monitor Patient #1 for signs of nephrotoxicity, or of the other values including the elevated BUN and Creatinine levels and said she doesn't know why they didn't stop the Vancomycin at "19." The "Resumption of Care" on 02/10/21 documents Patient #1 was discharged after hospitalization from 02/01/21 to 02/09/21 with orders for twice daily IV antibiotics. On 02/16/21, new physician orders were provided to discontinue one of 2 IV antibiotics and to start Minocycline (antibiotic) every 12 hours for 3 weeks, and that the first dose of Minocycline was to be given in the hospital on 02/17/21. However, "Skilled Nursing Notes" did not document any evidence that this medication was given by the Home Health Nurse until 02/19/21. A fax to Patient #1’s physician with date/time of 06/09/21 at 10:19 AM, pages confirmed by the DCS, documents missed visit notifications for the following: 02/12/21 client cancelled morning visit, 03/09/21 client cancelled evening visit, 04/13/21 cancelled morning visit due to patient not available, and 04/14/21 cancelled morning visit due to patient not available. The fax does not include notification of a visit not made on 4/1/21 to administer Ciprofloxacin and Minocycline. During interview on 06/10/21 at 5:15 PM, the DCS confirmed the fax notification to physician sent on 06/09/21 for missed visits 02/12/21 to 04/14/21 was accurate and should have been sent timelier. During telephone interview with Patient #1's nurse, Staff "A" on 06/11/21 at 12:30 PM, she explained the first dose of Minocycline needed to be given in the hospital for increased monitoring in case of reaction, which is something they usually do for this medication, and the patient was advised to go to the Emergency Room (ER) for the first dose on 02/17/21, but Patient #1 did not go until 02/19/21, after which she started given the medication as ordered. Staff "A" reported she did not advise the physician that Patient #1 did not go to the ER when directed and thought Patient #1 would have communicated that with the physician directly. Staff "A" also reported Patient #1 scheduled medical visits at times that interfered with morning administration of the IV antibiotics, resulting in the missed antibiotic doses she was asked about on 04/01/21 and 04/13/21, but she did not know why that occurred and assumed the physician was aware of the missed doses.