Miracle Home Health Care, Inc.

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) was implemented for two of seventeen sampled patients (Patient 1 and Patient 15). This failure had the potential to result in health status decline. 1. A record review of Patient 1’s “Patient Profile” indicated a start of care date on 5/4/2024, with a primary diagnosis of encounter for change or removal of surgical wound dressing. A record review of Patient 1’s “Home Health Certification and Plan of Care”, for certification period 7/3/2024 to 8/31/2024, indicated the skilled nurse was to continue to assess wound response to treatment, signs and symptoms of wound infection. During a concurrent interview and record review on 7/19/204, at 4:08 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 1’s record titled, “LVN Wound Care Visit Note”, dated 7/8/2024. The DPCS stated the wound was due to be assessed on this visit and the record indicated it had not been assessed. The DPCS stated the record included a picture of the wound, but this was not enough to know if the wound was getting better or worse. The importance of assessing the wound was to prevent complication and further skin breakdown, wound infection, and other related complications. 2. During a record review of Patient 15’s “Patient Profile” indicated a start of care date on 7/5/2024, with a primary diagnosis of cerebral infarct, unspecified (disruption in blood flow to the brain). During a record review of Patient 15’s “Home Health Certification and Plan of Care”, for certification period 7/5/2024 to 9/2/2024, indicated the skilled nurse was to complete home visits once a week for nine weeks. During a concurrent interview and record review on 7/19/204, at 2:50 p.m., with the Director of Patient Care Services Designee (DD) of Patient 15’s medical record, DD stated Patient 15 did not have a skilled nurse visit the week of 7/7/2024. DD stated there were no communication notes to indicate the reason for the missed visit. During a record review of facility’s policy and procedure titled “Missed Visits” dated 1/28/2022, indicated “Missed visits will be communicated to the clinical supervisor and the patient’s physician. A missed visit will be rescheduled the same week if possible. Missed visit will be documented in the clinical record. During a record review of facility’s policy and procedure titled “Wound Care Policy” revised November 2020, indicated “wounds are to be measured weekly by clinician.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on observation, interview, and record review the Registered Nurse (RN) failed to conduct an initial assessment for one of seventeen sampled patients (Patient 3). This failure resulted in not identifying the complete needs of the patient to determine the interventions needed for the patient. A record review of Patient 3’s “Patient Profile” indicated a start of care date on 7/4/2024, with a primary diagnosis of gangrene (death of body tissue due to no blood flow) to the left lower leg. During an interview on 7/18/2024, at 10 a.m., Licensed Vocational Nurse 4 (LVN 4) stated the main purpose of the visit for Patient 3 was to provide wound care on the left lower leg due to an amputation (removal of a limb). During an interview at the home visit on 7/18/2024, at 10:03 a.m., Patient 3 stated he goes to dialysis (a process of removing body waste and fluid from the body when the kidneys do not work), three times a week. During a concurrent observation, and interview, during the home visit on 7/18/2024, at 10:50 a.m., LVN 3 performed a body assessment (examination). A catheter (tube) was observed on Patient 3’s right upper chest. LVN 3 stated this was the dialysis catheter. During a concurrent interview and record review on 7/19/2024, at 12:24 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 3’s record titled, “OASIS-E Start of Care”, dated 7/4/2024. The DPCS stated the nurse documented “hemodialysis”, without the location of the shunt. The DPCS stated the nurse needed to document about the dialysis catheter because it needed to be included in the plan of care, and to monitor the catheter for complications. The importance of assessing the catheter was because it can lead to life threatening conditions such as severe bleeding if it comes out. The catheter was very close to the heart, so there can be complications with the heart and lungs. The nurses needed to know about the catheter so they can assess the catheter for signs of infection too. The DPCS stated the plan of care did not have any interventions for the dialysis catheter. During a record review of facility’s policy and procedure titled “Initial and Comprehensive Assessment”, revised November 2021, indicated “The assessment will be patient-specific and comprehensive to include the patients need for home health care, rehabilitative care, social services, and discharge planning. This assessment will measure patient outcomes from data collected at the start of care and at the following defined intervals thereafter: significant change in condition per the agency’s policy and definition. Patients’ functional status, including but not limited to, the degree of self-care, and the amount and level of assistance needed in the following areas: The patients medical and psychosocial history, including pertinent diagnoses and prognosis. Any identified symptoms of pain. Past medical and surgical care including dates of onset/exacerbation.””

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to complete the comprehensive assessment for one of seventeen sample patients (Patient 3) within five days of admission. This failure had the potential to result in the delay to identify the patient’s care needs and provision of services. A record review of Patient 3’s “Patient Profile”, indicated a start of care date on 7/4/2024, with a primary diagnosis of gangrene (death of body tissue due to no blood flow) to the left lower leg. During an interview at the home visit on 7/18/2024, at 10:03 a.m., Patient 3 stated he was informed the day prior, on 7/17/2024, that Physical Therapy (PT) services would visit him today, 7/18/2024. During an interview on 7/19/2024, the Director of Patient Care Services (DPCS) stated PT services was late and resulted in a big delay of care. The DPCS stated the reason the PT evaluation was late was due to insurance processes. The DPCS stated the need for PT services was determined on the start of care visit, on 7/4/2024. The DPCS stated the PT evaluation needed to be done by 7/9/2024. Patient 3 had as a result of the delay in care was possible weakness of the leg affected, possible falls, and possible delay in gaining strength.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to evaluate and perform pain reassessment in accordance with the agency’s policies and procedure for one of seventeen sampled patients (Patient 9). This deficient practice has the potential to result in ineffective pain management. Findings: During a review of Patient 9’s Patient Profile sheet indicated a start of care date of 7/9/2024, with diagnoses including unspecified open wound, left lower leg, and cellulitis (bacterial infection of the skin) of left and right lower limb. During a review of Patient 9’s Home Health Certification and Plan of Care (POC) for the certification period starting from 7/9/2024 to 9/6/2024, included an order for the skilled nurse (SN) frequency of visits of three times a week for nine weeks. The skilled was to conduct an assessment and observation of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate) every visit, perform wound care on left lower leg, and to assess pain for location, character, intensity using the scale of 1-10 with 10 as the most intense level. The POC further indicated for the SN to report to the physician if the patient experiences pain levels greater than 6/10 or if the pain significantly impacts the patient’s ability to perform normal activities. During a concurrent interview and record review on 7/19/2024, at 11:55 a.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 9’s record titled “LVN (licensed vocational nurse) Wound Care Visit Note”, dated 7/11/2024. The DPCS stated Patient 9 had a pain level 7/10 or very intense pain on left lower leg. The DPCS stated and acknowledged there was no documented evidence Patient 9’s pain level was reassessed after a pain intervention and before the end of the SN visit. DPCS stated the agency’s SN should have reassessed patient’s pain to know if the pain intervention was effective. During a review of the agency’s policy and procedure titled, “Pain Assessment”, revised November 2020, indicated all patients will receive at least an initial pain assessment. When the patient or the clinician identifies pain, the following in-depth pain assessment information will be obtained whenever possible: pain intensity using a rating scale (on a scale of 0 – 10: 0=no pain; 10=unbearable pain), pain location, pain quality, onset, duration, alleviating and aggravating factors, and present pain management regimen and effectiveness.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to review, update, and document the patients’ currently used medications and treatments for four of seventeen sample patients (Patient 2, Patient 7, Patient 12, and Patient 15). This failure had the potential to result in placing the patients at risk of drug-to-drug interaction and harm by not knowing which medications they were taking. This failure resulted in patients not having an accurate and comprehensive medical list that could place the patients at risk for medication errors and adverse drug reactions. 2. During a review of Patient 7’s Patient Profile sheet indicated a start of care date of 6/12/2024, with diagnoses including mechanical complication of internal fixation (the method of physically reconnecting the bones) of bone of left lower leg, type 2 diabetes mellitus (a condition that results in too much sugar circulating in the bloodstream), and essential hypertension (high blood pressure). During a review of Patient 7’s Home Health Certification and Plan of Care for the certification period starting from 6/12/2024 to 8/10/2024, included an order for the skilled nurse (SN) frequency of visits of three times a week for nine weeks, for skilled assessment and observation of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate) every visit, perform wound care to left foot, and to instruct patient/caregiver on compliance to prescribed medications, frequency, refills and dosages. On 7/17/2024, at 10:45 a.m., a joint home visit was conducted at Patient 7’s residence with the licensed vocational nurse (LVN 1). Patient 7 was observed awake, alert, and oriented x 3 (to person, place, and time). On 7/17/2024, at 11:10 a.m., during a review of Patient 7’s current medication with LVN 1, a bottle of Ferosul (an iron supplement used to treat or prevent low blood levels of iron) 325 mg 1 tablet oral daily could not be found. However, the medication list provided by the HHA indicated Patient 7 was still taking the medication. During a concurrent interview, Patient 7 stated he was not taking Ferosul anymore for several weeks. During an interview on 7/19/2024, at 11:55 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated nursing staff need to review patient’s current medication on every nurse visit and update the medication list in the patient’s clinical record to prevent medication errors. During a review of the agency’s policy and procedure titled, “Medication Profile”, revised November 2020, indicated patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. 1. A record review of Patient 2’s “Patient Profile”, indicated a start of care date on 4/4/2024, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a concurrent observation, interview, and record review, at the home visit on 7/17/2024, at 2:50 p.m., Licensed Vocational Nurse 3 (LVN 3) reviewed the medications Patient 2 was taking. The following medications were not listed in Patient 2’s record titled, “Medication Profile”, printed on 7/16/2024: Meloxicam (to treat arthritis-join stiffening, causing pain) 7.5 mg (mg-milligram, unit of measurement), 1 tablet by mouth daily. Omeprazole (to treat too much stomach acid) 20 mg 1 capsule by mouth daily. LVN 3 stated the medication profile needed to be updated in the electronic medical record (EMR) every Sunday. During an interview on 7/17/2024, at 3:08 p.m., LVN 3 stated there were two different medication profile in the patients’ home, which did not have the same medications listed. LVN 3 stated this can create confusion for the patient. If the patient were to need paramedic services, the list is what the paramedics rely on. If there are two lists, paramedics do not know which list is accurate. 2. During a review of Patient 12’s medical record form title “Home Health Certification and Plan of Care” dated from 6/25/2024 – 8/23/2024, indicated a start of care date of 6/25/2024 with principal diagnosis of “encounter for change or removal of surgical wound dressing”. The form also indicated “Medications: Normal Saline… Losartan (medication to treat high blood pressure) …Metformin (medication to treat high blood sugar) … atorvastatin (medication to treat high cholesterol) … Lastly, the form indicated Patient 12 had a wound vacuum ordered.” During a record review of Patient 12’s medical record form titled “Physician Order” dated 7/13/2024, indicated “SN to discontinue the wound vac treatment”. The form also indicated Patient 12 was ordered Santyl ointment as part of his wound treatment order. During a record review of Patient 12’s medical record form titled “Medication Profile” received from HHA on 7/16/2024 as requested, the form indicated Patient 12 was ordered Atorvastatin, Losartan, Metformin, and normal saline. During a concurrent observation, interview, and record review, at the home visit on 7/17/2024 at 1 p.m., Licensed Vocational Nurse 3 (LVN 3) reviewed the medications Patient 12 was taking. The following medications were not listed in Patient 12’s record titled, “Medication Profile”, printed on 7/16/2024: Santyl – ointment medication for wounds Aspirin – blood thinner/pain medication Multivitamin Jardiance – medication for high blood sugar Patient 12 stated he has been taking Jardiance 10mg daily since 7/3/2024. LVN3 stated he reconciled Patient 12’s medication yesterday (7/16/2024) or the day before yesterday (7/15/2024). LVN3 stated he reconciles Patient 12’s medications weekly. LVN3 stated medications need to be reconciled to prevent medication errors. 3. During a review of Patient 15’s medical record form title “Home Health Certification and Plan of Care” dated from 7/5/2024 – 9/2/2024, indicated a start of care date of 7/5/2024 with principal diagnosis of “hemiplegia following cerebral infarct affecting right dominant side”. The form also indicated “Medications: Cephalexin (antibiotic), Sevelamer (medication to treat high phosphate blood level), levetiracetam (medication to treat seizures) and Carvedilol (medication to treat high blood pressure).” During a record review of Patient 15’s medical record form titled “Medication Profile” received from HHA on 7/19/2024 as requested, the form indicated “Cephalexin… Last day 7/7 by mouth (PO).” During a concurrent interview and record review on 7/19/2024 at 2:50 p.m. with the Director of Patient Care Services Designee (DD) of Patient 15’s Electronic Medical Record (EMR), DD stated Patient 15’s medication profile should have been reconciliation the week of 7/7/2024, but that week Patient 15 had a missed skilled nurse visit. DD stated it was important to reconcile Patient 15’s medication to make sure the patient finished the course of antibiotics and to prevent medication errors. During an interview on 7/18/2024 at 9:30 a.m. with DD, DD stated skilled nursing are to review and reconcile patients’ medications once a week. DD stated the visiting skilled nurse who reconciles the patients’ medications access their Electronic Medical Record (EMR) and update the patient’s medication list once the visit is complete. DD stated it was their responsibility to ensure patients take the ordered medications to prevent adverse effects from taking the wrong medication or dosage. During a record review of facility’s policy and procedure titled “Medication Profile” revised November 2020, indicated “During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen. Each patient and/or family/caregiver will receive appropriate written material for specific medication he/she is receiving. The material will contain information on actions of the medications, potential side effects, contraindications, and any special instructions when taking the specific medication.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure three of seventeen sampled patients (Patient 3, Patient 7, and Patient 12) plans of care (POC) included interventions needed to monitor the patients’ health status. This failure had the potential to result in health status decline related to the omission of the necessary interventions needed to reach the patient goals and prevent re-hospitalization. 2. During a review of Patient 7’s Patient Profile sheet indicated a start of care date of 6/12/2024, with diagnoses including mechanical complication of internal fixation (the method of physically reconnecting the bones) of bone of left lower leg, type 2 diabetes mellitus (a condition that results in too much sugar circulating in the bloodstream), and essential hypertension (high blood pressure). During a review of Patient 7’s OASIS (Outcome and Assessment Information Set - patient specific standardized data set that measures quality and outcomes) Resumption of Care assessment dated 6/25/2024, indicated Patient 7 had a PICC line (or peripherally inserted central catheter, is a thin, flexible tube that is inserted into a vein in the upper arm and guided into a large vein above the right side of the heart for long-term IV [intravenous, or into the vein] antibiotics [medicines that fight bacterial infections], nutrition, medications, and blood draws. During a review of Patient 7’s Home Health Certification and Plan of Care (POC) for the certification period starting from 6/12/2024 to 8/10/2024, included an order for the skilled nurse (SN) frequency of visits of three times a week for nine weeks, for skilled assessment and observation of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate) every visit, perform wound care to left foot, and to instruct patient/caregiver on compliance to prescribed medications, frequency, refills and dosages. However, the POC did not include the necessary care, assessment, and monitoring for complications of Patient 7’s PICC line. During an interview on 7/19/2024, at 11:55 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated and acknowledged Patient 7’s PICC line was not addressed in the POC. The DPCS stated the POC should have included catheter assessment and monitoring for complications like bleeding and signs of infection on every nurse visit. 1. A record review of Patient 3’s “Patient Profile”, indicated a start of care date on 7/4/2024, with a primary diagnosis of gangrene (death of body tissue due to no blood flow). During an interview at the home visit on 7/18/2024, at 10:03 a.m., Patient 3 stated he goes to dialysis (a process of removing body waste and fluid from the body when the kidneys do not work), three times a week. During a concurrent observation, and interview of the home visit on 7/18/2024, at 10:50 a.m., LVN 3 performed a body assessment (examination). A catheter (tube) was observed on Patient 3’s right upper chest. LVN 3 stated this was the dialysis catheter. During a concurrent interview and record review on 7/19/2024, at 12:24 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 3’s record titled, “OASIS-E Start of Care”, dated 7/4/2024. The DPCS stated the nurse documented “hemodialysis”, without the location of the shunt. The DPCS stated the nurse needed to document about the dialysis catheter because it needed to be included in the plan of care, to monitor the catheter for complications. The importance of assessing the catheter was because it can lead to life threatening conditions such as severe bleeding, if it comes out. The catheter is very close to the heart, so there can be complications with the heart and lungs. The nurses needed to know about the catheter so they can assess the catheter for signs of infection too. The DPCS stated the plan of care did not have any interventions for the dialysis catheter. During a concurrent interview and record review on 7/19/2024, at 12:25 p.m., the DPCS reviewed Patient 3’s record titled, “Home Health Certification and Plan of Care”, dated 7/4/2024 to 9/1/2024. The DPCS stated the dialysis catheter was not addressed in the POC. 2. During a review of Patient 12’s medical record form title “Home Health Certification and Plan of Care” dated from 6/25/2024 – 8/23/2024, indicated a start of care date of 6/25/2024 with principal diagnosis of “encounter for change or removal of surgical wound dressing”. The form also indicated Patient 12 had a wound vacuum ordered. During a record review of Patient 12’s medical record form titled “Physician Order” dated 7/13/2024, indicated “SN to discontinue the wound vac treatment”. The form also indicated Patient 12 was ordered Santyl ointment as part of his wound treatment order. During a record review of Patient 12’s medical record form titled “Medication Profile” received from HHA on 7/16/2024 as requested, the form indicated Patient 12 was ordered Atorvastatin, Losartan, Metformin, and normal saline. During a concurrent observation, interview, and record review, at the home visit on 7/17/2024 at 1 p.m., Licensed Vocational Nurse 3 (LVN 3) reviewed the medications Patient 12 was taking. The following medications were not listed in Patient 12’s record titled, “Medication Profile”, printed on 7/16/2024: Santyl – ointment medication for wounds. Patient 12 stated his right foot wound vacuum was discontinued on 7/11/2024 and started using Santyl at that time. During an interview on 7/18/2024 at 10:28 a.m. with DPCS, DPCS stated patients plans of care are not amended or updated when there is a new or revised doctor order. DPCS stated they used supplemented physician orders. The HHA failed to update Patient 12’s wound treatment plan. During a record review of facility’s policy and procedure titled “Care Planning Process” revised November 2021, indicated “A written individualized plan of care will be initiated… Based on the assessment and conclusions, the plan of care will include, but not be limited to…patient specific interventions and education; reasonable, measurable, and individualized goals and outcomes identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care.””

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on observation, interview, and record review, The Home Health Agency (HHA) failed to ensure all doctor’s orders were recorded in the plan of care (POC) for two of seventeen sampled patients (Patient 2 and Patient 12). This failure had the potential to result in errors in assessment or treatments due to the POC not reflecting the most recent doctor’s orders. 1. A record review of Patient 2’s “Patient Profile”, indicated a start of care date on 4/4/2024, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During an interview at the home visit on 7/17/2024, at 2:30 p.m., Licensed Vocational Nurse 3 (LVN 3) stated the wound orders was on hold because Patient 2 had a procedure done on it and the doctor did not want the HHA to do anything with the left leg. During an observation of the home visit on 7/17/2024, at 2:32 p.m., Patient 2 was sitting in a lounge chair. There was a bandage on the left leg, wrapped from ankle to just below the knee. The bandage had the words written on it, “do not remove”. During a concurrent interview and record review on 7/18/2024, at 2:07 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 2’s record titled, “Physician Order”, dated 7/1/2024. The DPCS stated this was the order to hold the wound treatment for 3 weeks. During a concurrent interview and record review on 7/18/2024, at 2:08 p.m., the DPCS reviewed Patient 2’s record titled, “Physician Order”, dated 7/11/2024. The DPCS stated the order indicated for the HHA to do an evaluation to report the necessity of home health. During a concurrent interview and record review on 7/18/2024, at 2:17 p.m., the DPCS reviewed Patient 2’s record titled, “Physician Order”, dated 7/12/2024. The DPCS stated the order indicated a change of nursing visit frequency to once a week for four weeks, and to hold the wound treatment. The DPCS stated the Plan of Care (POC) was not updated to reflect the most recent doctor’s orders. The DPCS stated the HHA used supplemental orders to update the plan of care, but those orders did not directly go into the plan of care. The DPCS stated the plan of case should be updated with the most updated doctor’s orders in case other staff take care of the patient, they know what do to. During a concurrent interview and record review on 7/18/2024, at 2:20 p.m., the DPCS reviewed Patient 2’s record titled, “Home Health Certification and Plan of Care-Recertification of Continuing Need for Care”, dated 6/3/2024 to 8/1/2024. The record indicated for the skilled nurse to do wound care three times a week for nine weeks. The DPCS stated the POC did not have the most updated skilled nurse visit frequency and wound treatment. 2. During a review of Patient 12’s medical record form title “Home Health Certification and Plan of Care” dated from 6/25/2024 – 8/23/2024, indicated a start of care date of 6/25/2024 with principal diagnosis of “encounter for change or removal of surgical wound dressing”. The form also indicated Patient 12 had a wound vacuum ordered. During a record review of Patient 12’s medical record form titled “Physician Order” dated 7/13/2024, indicated “SN to discontinue the wound vac treatment”. The form also indicated Patient 12 was ordered Santyl ointment as part of his wound treatment order. During a record review of Patient 12’s medical record form titled “Medication Profile” received from HHA on 7/16/2024 as requested, the form indicated Patient 12 was ordered Atorvastatin, Losartan, Metformin, and normal saline. During a concurrent observation, interview, and record review, at the home visit on 7/17/2024 at 1 p.m., Licensed Vocational Nurse 3 (LVN 3) reviewed the medications Patient 12 was taking. The following medications were not listed in Patient 12’s record titled, “Medication Profile”, printed on 7/16/2024: Santyl – ointment medication for wounds. Patient 12 stated his right foot wound vacuum was discontinued on 7/11/2024 and started using Santyl at that time. During an interview on 7/18/2024 at 10:28 a.m. with DPCS, DPCS stated patients plans of care are not amended or updated when there is a new or revised doctor order. DPCS stated they used supplemented physician orders. During a record review of facility’s policy and procedure titled “Care Planning Process” revised November 2021, indicated “Changes in the plan of care will be noted with the following documentation: assessment, plan of care with clinical outcome goals; care plan with specific services/actions to be taken; clinical notes; verbal orders. Clinicians will inform the patients physician or any changes that suggest a need to alter the plan of care. Changes must be written, dated, and signed by the professional making the changes. The organization shall provide the patient and caregiver with a copy of written instructions outlining: any treatment to be administered by the organization’s personnel and personnel acting on behalf of the organization, including therapy services.””

“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 interview and record review, the Home Health Agency (HHA) failed to notify the physician of a change of condition for one of seventeen sampled patients (Patient 1). This failure resulted in missed opportunity to alter the plan of care to meet the needs of the patient. A record review of Patient 1’s “Patient Profile” indicated a start of care date on 5/4/2024, with a primary diagnosis of encounter for change or removal of surgical wound dressing. A record review of Patient 1’s “Home Health Certification and Plan of Care”, for certification period 7/3/2024 to 8/31/2024, indicated the skilled nurse was to continue the doctor if there were significant clinical findings. During a concurrent interview and record review on 7/19/2024, at 1:17 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 1’s record titled, “LVN Wound Care Visit Note”, dated 7/8/2024. The DPCS stated the document did not indicate the doctor was notified of Patient 1 needing to go to the emergency room. During an interview on 7/19/2024, at 2:02 p.m., Licensed Vocational Nurse 3 (LVN 3) stated he visited Patient 1 on 7/8/2024 and instructed him to go to the emergency room (ER). LVN 3 stated the reason he instructed Patient 1 to go the ER was because LVN 3 was concerned, he had lost weight, looked dehydrated, and had not seen a doctor for over a month. LVN 3 stated he was not concerned about the wound. LVN 3 stated he did not notify any doctor because he was sure Patient 1 would go to the ER. During an interview on 7/19/2024, at 4:20 p.m., the DPCS stated LVN 3’s concerns about Patient 1 losing weight and looking dehydrated was considered a change of condition and should have been reported to the doctor. The DPCS stated the most important thing was coordination of care. The HHA needed to get a specific order on what needs to be done for the patient, to prevent re-hospitalization. During a record review of facility’s policy and procedure titled “Monitoring Patient’s Response/Reporting to Physician” revised November 2021, indicated “Clinicians will monitor, and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. The patient’s physician will be contacted on the same day when any of the following occur: changes in the patient’s condition; when a visit is missed for any reason; All conferences or attempts to communicate with the physician will be documented in the clinical record.””

“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 interview, and record review, the HHA failed to ensure the plan of care reflected current information from the updated comprehensive assessment for one of seventeen sampled patients (Patient 4). This failure resulted in the patients not receiving the care as written in the plan of care. A record review of Patient 4’s “Patient Profile”, indicated a start of care on 6/13/2024, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. A record review of Patient 4’s “Home Health Certification and Plan of Care”, dated 6/13/2024 to 8/11/2024, indicated the patient was to have Occupational Therapy (OT) and Physical Therapy (PT). During a concurrent interview and record review on 7/19/2024, at 11:25 a.m., the Director of Patient Care Services (DPCS) reviewed Patient 4’s record titled, “Occupational Therapy Evaluation and Plan of Care”, dated 7/15/2024. The DPCS stated the record indicated the OT visits were to occur twice a week for three weeks starting the week of 7/21/2024, with a re-evaluation on the 6th visit. The DPCS stated the POC did not have this information and needed to be updated to include it. During a concurrent interview and record review on 7/19/2024, at 11:28 p.m., the DPCS reviewed Patient 4’s record titled, “PT Initial Evaluation”, dated 6/18/2024. The DPCS stated the PT were to visit the patient twice a week for three weeks, then once a week for one week. The DPCS stated the POC did not have this information and needed to be updated to include it.”

“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 interview and record review, the agency’s skilled nurse (SN) failed to notify the physician of the patient’s intense pain during the home visit for one of seventeen sampled patients (Patient 9). This deficient practice has the potential to result in the delay of treatment to mitigate the patient’s pain causing more discomfort affecting the patient’s quality of life. Findings: During a review of Patient 9’s Patient Profile sheet indicated a start of care date of 7/9/2024, with diagnoses including unspecified open wound, left lower leg, and cellulitis (bacterial infection of the skin) of left and right lower limb. During a review of Patient 9’s Home Health Certification and Plan of Care (POC) for the certification period starting from 7/9/2024 to 9/6/2024, included an order for the skilled nurse (SN) frequency of visits of three times a week for nine weeks, for skilled assessment and observation of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate) every visit, perform wound care on left lower leg, and to assess pain for location, character, intensity using the scale of 1-10 with 10 as the most intense level. The POC further indicated for the SN to report to the physician if the patient experiences pain levels greater than 6/10 or if the pain significantly impacts the patient’s ability to perform normal activities. During a concurrent interview and record review on 7/19/2024, at 11:55 a.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 9’s record titled “LVN (licensed vocational nurse) Wound Care Visit Note”, dated 7/11/2024. The DPCS stated Patient 9 had a pain level 7/10 – very intense pain on left lower leg, and the visiting nurse should have notified the physician. The DPCS stated and acknowledged there was no documented evidence Patient 9’s very intense pain level was reported to the physician which had the potential for patient needs go unmet. During a review of the agency’s policy and procedure titled, “Care Planning Process” revised November 2021, indicated all clinicians including the physician (or other authorized licensed independent practitioner) involved in the patient’s care, either directly or indirectly, will contribute to the plan of care. The plan of care will be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies and services required to meet the patient’s needs. During a review of the agency’s policy and procedure titled, “Monitoring Patient’s Response/Reporting to Physician” revised November 2021, indicated clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. All conferences or attempts to communicate with the physician will be documented in the clinical record.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based interview and record review the Home Health Agency (HHA) failed to ensure clinical records reflected the care provided for two of seventeen sample patients (Patient 12 and Patient 13). This failure had the potential to result in an incomplete clinical record. 1. During a review of Patient 12’s medical record form title “Home Health Certification and Plan of Care” dated from 6/25/2024 – 8/23/2024, indicated a start of care date of 6/25/2024 with principal diagnosis of “encounter for change or removal of surgical wound dressing”. During a record review of Patient 12’s medical record form titled “LVN Wound Vac Note” dated 7/9/2024, indicated it was signed by License Vocational Nurse 3 (LVN3) on 7/9/2024. During a record review of Patient 12’s medical record form titled “Task Details – LVN/LPN Visit” undated, indicated License Vocational Nurse 3 (LVN3) “submitted with signature” visit note for 7/9/2024 on 7/16/2024. During a record review of Patient 12’s medical record form titled “LVN Wound Vac Note” dated 7/11/2024, indicated it was signed by LVN3 on 7/11/2024. During a record review of Patient 12’s medical record form titled “Task Details – LVN/LPN Visit” undated, indicated LVN3 “submitted with signature” visit note for 7/11/2024 on 7/17/2024. During a concurrent interview and record review on 7/18/2024 at 12:30 p.m. with the Director of Patient Care Services (DPCS) of Patient 12’s Electronic Medical Record (EMR), DPCS stated License Vocational Nurse 3 (LVN3) documented Patient 12’s visits conducted on 7/9/2024 and 7/11/2024 on 7/17/2024. DPCS stated LVN3 documented Patient 12’s visits late. 2. During a review of Patient 13’s medical record form title “Home Health Certification and Plan of Care” dated from 6/15/2024 – 8/33/2024, indicated a start of care date of 4/16/2024 with principal diagnosis of “encounter for change or removal of nonsurgical wound dressing”. The form also indicated “SN Frequency: 1w9”. During a record review of Patient 13’s medical record form titled “LVN Wound Vac Note” dated 7/11/2024, indicated it was signed by LVN3 on 7/11/2024. During a record review of Patient 13’s medical record form titled “Task Details – LVN/LPN Visit” undated, indicated LVN3 “submitted with signature” visit note for 7/11/2024 on 7/17/2024. During a concurrent interview and record review on 7/18/2024 at 12:30 p.m. with the DPCS of Patient 13’s EMR, DPCS stated License Vocational Nurse 3 (LVN3) documented Patient 13’s visit conducted on 7/11/2024 on 7/17/2024. DPCS stated LVN3 documented Patient 13’s visits late. During an interview on 7/18/2024 at 10:59 a.m. with the HA’s EMR representative (EMRR), EMRR stated a patients “Activity Log” indicates the username of the person who created the document, if there were changes to the document and who made the changes, the dated, and times, and a brief description or action that was made. During an interview on 7/18/2024 at 12:30 p.m. with the DPCS, DPCS stated the vising nurses have five days to complete and upload their patient visit notes. DPCS stated notes should be uploaded into their EMR system to ensure there is updated patient information.”