Every finding on record at Amber Home Health Care, Inc

A recertification survey for Emergency Preparedness was conducted by the Michigan Department of Licensing and Regulatory Affairs, Bureau of Community and Health Systems on 4/21/22 at: Amber Home Health Care 29792 Telegraph Rd., Suite 130 Southfield, MI 48034 At the time of the survey, the agency did not operate any branch offices or subunits. At the survey's conclusion, the agency was found to be in substantial compliance with standard citations with the requirements for participation in Medicare/Medicaid at 42 CFR §484.102, Emergency Preparedness.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency (HHA), failed to provide initial training in Emergency Preparedness (EP) policies and procedures to all contracted employees, and failed to maintain documentation of training, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: On 4/21/22 at 2:30 p.m., the Chief Operations Officer/Clinical Manager (COO#1) was asked to provide evidence of initial EP training for all contracted staff employed by the agency, but was unable to do so. When asked who provides EP training for contracted staff, COO#1 stated, "The staffing agency provides the training to the contracted staff." There was no documented evidence that initial EP training had been provided to contracted staff as required. During an interview on 4/21/22 at 3:15 p.m., COO#1 acknowledged the above findings.

The following Immediate Jeopardy was identified during an authorized onsite Medicare recertification survey conducted by the Michigan Department of Licensing and Regulatory Affairs on 4/18/22 through 4/21/22 at: Amber Home Health Care 29792 Telegraph Rd., Suite 130 (unapproved) Southfield, MI 48034 At the time of the survey, the Agency did not operate any branch locations. The services the Agency provides are: Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW), Home Health Aide (HHa) and Speech Therapy (ST). Clinical records reviewed for this survey included: 7 active records with home visits, 5 active records without home visits, and 5 discharged records, for a total of 17 records reviewed. On 4/21/22 at 9:15 AM, Immediate Jeopardy was approved due to the Agency's failure to perform baseline assessments and re-assessments, promptly alert physician of significant changes in patient condition, and failed to deliver care as ordered, resulting in hospitalizations, cardiac arrest, and death. The following Immediate Jeopardy Condition Level Citations were out of compliance as follows: 42 CFR §484.60: Care Planning, Coordination, Quality of Care. 42 CFR §484.75: Skilled Professional Services. The Agency's Administrator and Chief Operations Officer were notified of the Immediate Jeopardy at 10:00 AM and 10:46 a.m. on 4/21/22. The Immediate Jeopardy's were removed at 2:18 p.m. and 3:35 PM on 4/21/22 after the review and approval of the Agency's immediacy Plan of Correction. The Agency was found to be in compliance with staff vaccination requirements. As a result of the Condition level noncompliance on 4/21/22, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

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 observation, interview and record review, the agency failed to ensure that 2 (MR's #1, 4 ) of 2 patient's observed during home visits, from a total of 17 sampled records reviewed, were included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided, the disciplines that would be furnishing care and when services would be interrupted, resulting in a lack of inclusion in planning, lack of informed consent, the potential for physical decline, missed visits and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 4/3/22 with diagnoses that included Left Hip Replacement. On 4/18/22 at 3:10 p.m., a joint survey home visit was conducted with the Licensed Practical Nurse (LPN #1). During the visit, the patient's admission packet was reviewed. The calendar that would include the patient's schedule of proposed visits was noted to be blank. Additionally, during the visit, the patient expressed concerns that the Physical Therapist (PT #1) had not conducted any further visits and stated, "I saw him twice and I haven't heard from him or the Agency since." Upon review of the clinical record on 4/19/22 at 8:30 a.m., it was noted that PT #1 was schedule to see the patient 2x/wk. x 2 wks., 1x/wk. x 2 wks. The record revealed that PT #1 saw the patient on 4/10/22 and 4/9/22. There were no further visits made after 4/9/22. These findings were reviewed with and acknowledged by the Chief Operations Officer (COO #1) during an interview on 4/20/22 at 3:24 p.m. Regarding the PT visits, COO #1 reported, "I see a PT note dated 4/9/22 saying visits would be held. I don't understand. Why wasn't this information relayed to the patient?" The Agency failed to ensure that the patient was included in the overall planning of her care. MR #4: The patient's SOC was 12/4/21. The period of review was 4/3/22 through 4/21/22 with diagnoses that included Cellulitis Left Lower leg and Acute on Chronic Congestive Heart Failure. A joint home visit was conducted with the Home Health Aide on 4/20/22 at 8:30 a.m. During the home visit, the patient was queried as to how he stays abreast of his scheduled visits and reported, "They (disciplines) either call me or text me and tell me what day they will be out, and they ask me if that time is okay with me." There was no completed calendar of proposed visits available for review. Additionally, during the visit, the patient expressed concerns about the Physical Therapist (PT) no longer making visits to his home. Upon review of the clinical record, PT services had not been renewed for this certification period. The Agency failed to ensure the patient was included in the overall planning of his care. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/21/22 at 9:50 a.m. When queried about PT services, COO #1 reported, "I see 2 missed visits in February due to weather but I'm not sure what happened here. I thought he (patient) was still receiving PT services. I'm going to have to do some research. No one informed the patient."

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on interview, the Agency failed to provide documented evidence of the existence of complaints received, details of the investigation and the resolution of the complaints, as per this requirement, resulting in the potential for unaddressed patient/family concerns, inability to exercise one's rights and unmet care needs. Findings include: On 4/21/22 at 2:45 p.m., the Chief Operations Officer (COO #1) was asked for permission to review the agency's complaint log. Shortly after, COO #1 acknowledged having received complaints and reported that she was unable to locate any documentation of the Agency's complaints. The Agency failed to ensure that all complaints, investigative measures and the resolutions, as appropriate, were documented as per this requirement. These findings were reviewed with and acknowledged by COO #1 at the time of discovery.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status for 10 (MR#'s 1, 2, 5, 6, 7, 8, 9, 10, 11, and 13) of 17 records reviewed, resulting in the potential for unmet care needs and a poor outcome (See G528); failed to ensure a registered nurse performed a follow-up medication reconciliation in 2 of 2 records reviewed in which therapy services performed the initial comprehensive assessment (MR's #11 and #15), failed to notify the physician of major drug interactions and duplicative drug therapies in 11 (MR#'s 1, 2, 3, 5, 6, 8, 9, 11, 12, 13, and 15) of 17 records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency (See G536); and failed to ensure the transfer summary was complete, detailed, and provided the patient's current health status at the time of transfer, progress toward goals, and forwarded to the receiving facility in 1 (MR# 11) of 2 records reviewed with transfer summaries (See G564). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR §484.55 Comprehensive Assessment of Patients.

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 observation, record review, and interview, the Agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, measurable data to use as a baseline for future assessments, and history of events leading to current home care needs for 10 (MR#s 1, 2, 5, 6, 7, 8, 9, 10, 11, and 13) of 17 sampled records reviewed, resulting in incomplete clinical information to aid in determining the current and future care needs of the patient. Findings included: MR #1: The patient's start of care (SOC) was 4/3/22 with diagnoses that included Left Hip Replacement. On 4/19/22 at 8:30 a.m., during the clinical record review, it was noted that the Initial comprehensive Assessment dated 4/3/22 completed by the Registered Nurse (RN) revealed the following: There were no dates of onset or exacerbation for the listed diagnoses under section M1021 and M1023 and no documentation of the events that lead to the need for home care referral. Additionally, the assessment failed to include information regarding the patient's left hip surgery or incision. These findings were reviewed with and acknowledged by the Chief Operations Officer (COO #1) during an interview on 4/20/22 at 3:24 p.m. MR #2: The patient's SOC was 1/28/22 with diagnoses that included Hypertensive Heart and Chronic Kidney Disease with Heart Failure, Congestive Heart Failure (CHF), Acute Respiratory Failure and Pressure Ulcer right buttock. During the record review on 4/19/22 at 10:30 a.m., it was noted that the Initial Comprehensive Assessment dated 1/28/22 completed by the RN revealed: No dates of onset/exacerbation for the listed diagnoses. The section that assessed the patient's baseline weight was left blank. Additionally, section M1060 (Height and Weight) documented that the patient's height and weight was "Not assessed." The section titled "Cardiovascular" documented the patient had "Bilateral LE (lower extremity) edema, however there was no documented measurements. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/20/22 at 3:40 p.m. who reported, "If they (patients) don’t have a scale they should go to the initial referral and record the most recent height and weight they have and indicate that is the most recent and it’s not an actual. At least we would have a baseline.” No response was given regarding the additional identified concerns. MR #5: The patient's SOC was 4/7/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Atrial fibrillation and Diabetes Mellitus. During the record review on 4/20/22 at 12:55 p.m., the Initial Comprehensive Assessment dated 4/7/22 completed by the Occupational Therapist (OT) revealed: There were no dates of onset or exacerbation for the listed diagnoses in section M1021/M1023 and no documentation of the status of those diagnoses. Additionally, there was no documentation of the events that lead for the need for home care referral. The section that addressed the patient's weight was left blank. Section M1060 documented that the patient's Height/Weight was "Not assessed." The Cardiovascular section was left blank. The above findings were reviewed with and acknowledged by COO #1 during an interview on 4/21/22 at 10:06 a.m. Agency Policy: "Initial Assessments/Comprehensive Assessments" 9.6.1 (Revised March 2018) stated, "Each patient admitted will receive a comprehensive assessment. The assessment will reflect the patient's current health status and include information to demonstrate the patient's progress toward achievement of desired outcomes. The comprehensive assessment will identify the patient's need for home care and meet the patient's need for Medical, Rehabilitative, Nursing, Social, and Discharge planning." MR#11: This patient was admitted to the Agency on 3/9/22 with diagnoses of heart failure, shortness of breath, and pressure ulcer of left buttock-stage 2. During record review on 4/20/22, it was noted that the start of care (SOC) comprehensive assessment completed by Physical Therapy (PT) on 3/9/22, failed to document dates of onset, prior treatments, outcomes, or history of how the primary diagnoses (above) and three additional secondary diagnoses led to the need for home care. Review of the physician referral (3/7/22) for home care noted the patient's weight as 139 lbs. and the need for daily weights due to fluid overload from acute congestive heart failure. In addition, during the referral visit the patient was positive for shortness of breath and stated, "I feel fluid overloaded." The SOC assessment failed to incorporate this pertinent information and failed to take notice when the patient's SOC weight was documented as "190" (documentation is unclear if actual or stated). Subsequently, the SOC assessment failed to propagate needed interventions to monitor for fluid overload on the patient's Plan of Care. On the fifth week after admission (4/10/22), the patient was admitted to the hospital due to fluid overload with no evidence of the patient's weight being assessed from 3/11/22 through the last home visit on 4/6/22. The Agency failed to ensure the SOC comprehensive assessment included vital information from the referral needed to address the patient's current health care needs and potentially avoid the poor outcome of hospitalization. MR #13: The patient's start of care was 11/11/21 with diagnoses that included left tibia and patella fracture, anemia, heart disease, and hypertension. During the record review on 4/20/22, the Initial Comprehensive Assessment dated 11/11/21 completed by the Registered Nurse (RN), failed to document any dates of onset or exacerbation for the 10 listed diagnoses in sections M1021 and M1023. The Cardiovascular section was void of past medical history that detailed potential contributory factors leading up to the need for home care admission. These findings were reviewed and acknowledged by the Chief Operations Officer (COO#1) during an interview on 4/21/22 at 1:06 PM. COO#1 stated, "Obviously they (clinicians) need training to look at the whole history of the patient and get the needed interventions to prevent this from happening again." MR#6: The Start of Care (SOC) was dated 4/12/2022. The Plan of Care for the Certification Period 4/12/2022 to 6/10/2022 identified diagnoses of Fracture of Femur (FX Femur), Left artificial hip joint, Diabetes type 2 (DM2), Hypertension (HTN), and Atrial Fibrillation (A-Fib). Upon review of the SOC Comprehensive Assessment under the category of "Past Medical History," the following conditions were identified by checkmarks: "Skin tear right dorsal forearm, diabetes, urinary incontinence, Atrial fibrillation, macular degeneration, osteoporosis, Right hip surgery, and Hip surgery for fracture." It was noted the Skilled Nurse failed to document the patient's past medical history that included the unique dates of onset, exacerbations, treatments and outcomes that contributed to the need for the current admission. There were 12 different diagnoses listed under the Category of "M1021: Primary Diagnoses and M1023: Other Diagnoses." All the diagnoses were identified to have the same date of onset of 4/12/2022 with no further history or information provided such as the unique dates of onset, treatments, exacerbations, or current status for each of the above identified diagnoses. MR#7: The (SOC) was dated 3/16/2022. The Plan of Care for the certification period of 3/16/22 to 5/14/2022 identified a primary diagnosis of Unilateral primary osteoarthritis of the right knee and secondary diagnoses of mild cognitive impairment, history of Transient Ischemic Attack (TIA), and hypotension. Upon review of the SOC Comprehensive Assessment under the category of "Past Medical History," the following conditions were identified by checkmarks, "Osteoarthritis of lower extremity, Falls, Urinary Incontinence." It was noted upon review of the "Past Medical History," that the Skilled Nurse failed to document the patient's past medical history that included the unique dates of onset, exacerbations, treatments and outcomes that contributed to the need for the current admission. MR#8: The Start of Care was dated 3/24/2022, The POC for the certification period 3/24/2022 to 5/22/2022 identified diagnoses of Hemiplegia following CVA (Cerebral Infarction) affecting left non-dominant side, dysarthria, mild cognitive impairment, neoplasm of cerebral meninges, iron deficiency anemia, hypothyroidism, hyperhidrosis, Diabetes type (2), Hypertension (HTN), Coronary Artery Disease (CAD), and wheelchair dependence. Upon review of the SOC Comprehensive Assessment under the category of "Past Medical History," the following conditions were identified by checkmarks: Coronary Artery Disease, Hypertension, Cerebral Vascular Accident, Diabetes, Thyroid Problems, Asthma, Abdominal pain, Arthritis, Gastroesophageal Reflux Disease, Brain Tumor, hyperlipidemia, and sleep apnea. There were 20 different diagnoses listed under the Category of "M1021: Primary Diagnoses and M1023: Other Diagnoses." These diagnoses failed to include any further history or information such as the unique dates of onset, treatments, exacerbations, or current status for each diagnosis. MR#9: The SOC was dated 12/12/2021. The POC for the certification period 12/12/2021 to 2/09/2022 identified diagnoses of Hypertensive Heart Disease with Heart Failure (HF), Chronic systolic and diastolic heart failure (CHF), ventricular tachycardia (V-tach), Chronic atrial fibrillation (A-fib), hyperglycemia, and Coronary Artery Disease (CAD). Upon review of the SOC Comprehensive Assessment under the category of "Past Medical History," the following conditions were identified with checkmarks: "Congestive Heart Failure (CHF), Arrhythmia, Hypertension, and Depression. There were15 different diagnoses listed under the Category of "M1021: Primary Diagnoses and M1023: Other Diagnoses." These diagnoses failed to include any further history or information such as the unique dates of onset, treatments, exacerbations, or current status for each diagnosis. MR#10: The SOC was dated 3-17-2022. The POC for the certification period 3/17/2022 to 5/15/2022 identified diagnoses of Parkinson's Disease, History of falling, Alcohol abuse, Obstructive Sleep apnea, and Personal History of Nicotine dependence. Upon review of the SOC Comprehensive Assessment under the category of "Past Medical History," the following two diagnoses were identified with checkmarks: Alcoholic Substance Abuse, Upper Lobe Lung Surgery. There were 5 different diagnoses listed under the Category of "M1021: Primary Diagnoses and M1023: Other Diagnoses" as follows: "Parkinson's Disease, History of Falling, Alcohol abuse, in remission, Obstructive Sleep Apnea, and Personal history of nicotine dependence. These diagnoses failed to include any further history or information such as the unique dates of onset, treatments, exacerbations, or current status for each diagnosis. These findings were reviewed and confirmed by the Chief Operations Officer/Clinical Manager/COO#1 on 4/21/2022 at 2:00 p.m.

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, record review and interview, it was determined the Agency failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required, and failed to ensure the physician was notified of potential severe drug interactions and duplicative drug therapies in 12 (MR#'s 1, 2, 3, 5, 6, 8, 9, 11, 12, 13, 15, and 17) of 17 sampled records reviewed, and failed to have skilled nursing perform a comprehensive drug review in 4 (MR#'s 3, 5, 11 and 15) of 4 records which therapy only cases were assigned, resulting in the potential for harmful medication effects for all 264 patients currently serviced by this Agency. Findings include: Policy: "Medication Reconciliation" 8.15.1 (Revised March 2018) stated, "The Agency will reconcile patient's medications at time of admission and on an ongoing basis in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy... Any concerns or discrepancies will be reconciled by a RN with the patient's physician... In therapy only cases, the therapist submits a list of medications collected during the comprehensive assessment to RN for review, who contacts the physician if indicated." MR#11: This patient was admitted to the Agency on 3/9/22 with diagnoses of heart failure, shortness of breath, and pressure ulcer of left buttock-stage 2. On 4/20/22, review of the start of care (SOC) assessment noted that Physical Therapy (PT) opened the case despite having a Registered Nurse (RN) also being ordered on Plan of Care dated 3/9/22. During a review of the clinical record, section M2001 of the Initial Comprehensive Assessment/Oasis dated 3/9/22, completed by PT documented, "No issues found during review." However, no evidence was found that a subsequent drug review had been performed by a RN as stipulated by the policy referenced above. MR#12: The patient's SOC date was 12/23/21 with diagnoses that included pressure ulcer of right buttock-stage2, pressure ulcer of left buttock-stage 2, and Parkinson's disease. On 4/20/22, during a review of the clinical record, section M2001 of the Initial Comprehensive Assessment/Oasis dated 12/23/21, completed by the RN indicated "No issues found during review." The patient's 15 prescribed medications were entered in "Drugs.com (online drug interaction checker) and revealed 6 major (most severe) drug interactions and 3 duplicative drug therapies (including a daily Tylenol dosage of up to 7500 mg.-maximum recommended is 4000 mg. to avoid liver damage). There was no documented evidence that a drug review had been conducted or the physician was notified of the 3 major drug interactions and clarification needed concerning the excessive Tylenol dosage. MR#13: The patient's SOC date was 11/11/21 with diagnoses that included left tibia fracture, left patella fracture, heart disease, and history of falling. On 4/20/22, during a review of the clinical record, section M2001 of the Initial Comprehensive Assessment/Oasis dated 11/11/21, completed by the RN indicated "No issues found during review." The patient's 11 prescribed medications were entered in "Drugs.com" which revealed 3 major drug interactions. There was no documented evidence that a drug review had been conducted, or the physician was notified concerning the major drug interactions. MR#15: This patient was admitted to the Agency on 2/13/22 with diagnoses of Parkinson's disease, chronic kidney disease, and peripheral neuropathy. On 4/20/22, review of the SOC assessment noted that PT opened the case despite having an RN also being ordered on the referral dated 2/11/22. During a review of the clinical record, section M2001 of the Initial Comprehensive Assessment/Oasis dated 2/13/22, completed by PT documented, "No issues found during review." with no physician follow-up noted. However, no evidence was found that a subsequent drug review had been performed by a RN as required. In addition, the patient had a resumption of care (ROC) with subsequent medication reconciliation by the RN dated 3/18/22. No medication changes were noted between the SOC medication reconciliation performed by PT and the ROC medication reconciliation performed by the RN. However, the RN documented physician notification due to "severe medication interactions" with "action taken". These findings were reviewed and acknowledged by the Chief Operations Officer (COO#1) during an interview on 4/21/22 at 2:11 PM. COO#1 stated, "I was trusting the clinicians that they were doing the med review, I can't show you interactions that were ran between PT and nursing, so I don't know why they had different results with the same medication profile. This needs to be looked at much more closely." The Agency failed to provide evidence that a comprehensive drug review was performed, and failed to ensure that an RN had reviewed the SOC patient medication list when performed by therapy disciplines. MR #1: The patient's start of care (SOC) was 4/3/22 with diagnoses that included Left Hip Replacement. During the clinical record review on 4/19/22 at 8:30 a.m. it was noted that section M2001 of the Initial comprehensive Assessment (ICA) dated 4/3/22 completed by the Registered Nurse (RN) documented, "Not Assessed/No Information." The RN failed to conduct a comprehensive review of all the patient's medications in order to determine the presence of any untoward reactions. The patient's 14 prescribed medications were entered in "Drugs.com" (online drug interaction checker) and revealed 2 major drug to drug interactions, 1 major drug to food interaction, 14 moderate drug to drug interactions, 4 moderate drug to food interactions and 8 duplicate drugs. No comprehensive drug review had been conducted as per this requirement. These findings were reviewed with the Chief Operations Officer (COO #1) during an interview on 4/20/22 at 3:24 p.m. who responded, "That just can't be." MR #2: The patient's SOC was 1/28/22 with diagnoses that included Hypertensive Heart & Chronic Kidney Disease with Heart Failure, Congestive Heart Failure (CHF) and Pressure Ulcer right buttock. During the record review on 4/19/22 at 10:30 a.m., it was noted that section M2001 of the ICA dated 1/28/22 completed by the RN documented "No issues found during review. Upon further review, there was no documented evidence that a drug review had been conducted. The patient’s 12 prescribed medications, including oxygen, were entered in Drugs.com and revealed: 8 moderate drug to drug interactions and 3 drug to food interactions. Additionally, there was no documented evidence that the Physician had been notified of the findings. On 4/20/22 at 3:40 p.m., during an interview, COO #1 was made aware of the findings and reported, "All Severe and Moderate findings are to be reported to the Physician. We’ve (staff) been talking about that. I asked that staff report moderate interactions as well to the Physician.” MR #3: The patient's SOC was 9/30/21 with a diagnosis of Displaced Fracture Cervical Vertebrae. During the record review on 4/19/22 at 1:30 p.m., it was noted that section M2001 of the ICA dated 9/30/21 completed by the Physical Therapist (PT) documented, "No issues found during review." Upon further review, there was no documented evidence that a drug review had been conducted. The section of the patient's "Medication Profile" dated 9/30/21 that was to be signed by the Registered Nurse, was signed by the Physical Therapist. There was no evidence that the RN provided oversight of the drug review process. The patient's 11 prescribed medications were entered in Drugs.com and revealed: 2 major drug to drug interactions, 8 moderate drug to drug interactions, 4 moderate drug to food interactions and 1 duplicate drug. The Agency failed to ensure the Comprehensive Assessment included a review of all the patient's medication in order to identify any untoward reactions and failed to notify the Physician of the findings. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/21/22 at 9:40 a.m. MR #5: The patient's SOC was 4/7/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Atrial Fibrillation and Diabetes Mellitus. During the record review it was noted that section M2001 of the ICA dated 4/7/22 completed by the Occupational Therapist (OT) documented, "No issues found during review." The patient's Medication Profile dated 4/7/22 completed by the OT documented, "No Discrepancies, No Interactions. The section titled "Nurse Signature and Title" was signed by the Occupational Therapist. The patient’s 16 prescribed medications were entered in Drugs.com and revealed 15 moderate drug to drug interactions, 7 moderate drug to food interactions and 2 duplicate drugs. Upon further review, there was no evidence that the RN provided oversight of the drug review process, or the Physician had been notified of the findings. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/21/22 at 10:06 a.m. MR#17: This patient was admitted to the agency on 12/28/21 with diagnoses of acidosis and altered mental status. The patient was then recertified for care on 2/25/22. The patient resides in an assisted living facility. During record review on 4/19/22, it was noted the 2/26/22 plan of care (POC) included a list of 12 different medications for this patient. A joint surveyor home visit was conducted with RN #3 (registered nurse) on 4/20/22 at 10:00 a.m. RN #3 was asked to review the patient's current medications. RN #3 utilized the computer and electronic medical record system used by the facility. While reviewing the patient's current medications with RN #3 at 10:45 a.m., it was observed that nine additional medications were included that were not listed on the POC. The medications included the following: Metformin, Calmoseptine ointment, Nystatin cream, Coreg, Zofran, Levetiracetam, Afrin, Allopurinol, and Ferrous sulfate. The patient had been on Metformin since 2/18/20, Coreg since 3/25/20, and Levetiracetam since 12/24/21. Rn #3 acknowledged at the time of the findings that the additional medications had not been reviewed for any potential adverse effects or significant drug interactions. MR#6: The Start of Care (SOC) was dated 4/12/2022. The Plan of Care for the Certification Period 4/12/2022 to 6/10/2022 identified diagnoses of Fracture of Femur (FX Femur), Left artificial hip joint, Diabetes type 2 (DM2), Hypertension (HTN), and Atrial Fibrillation (A-Fib). The patient was currently prescribed 14 medications including amiodarone, simvastatin, and tramadol. During a review of the patient's medications via drugs.com, there were 2 major interactions identified between the patient's currently prescribed medications as follows: 1) the concurrent use of simvastatin and amiodarone may significantly increase blood levels of simvastatin increasing the risk of side effects such as liver damage and rhabdomyolysis (breakdown of skeletal muscle tissue). Upon review of the comprehensive assessment on 4/20/2022 under the category of "M2001: Drug Regimen Review," the Registered Nurse who conducted the Start of Care Assessment documented "No issues found during review." MR#8: The Start of Care was dated 3/24/2022, The POC for the certification period 3/24/2022 to 5/22/2022 identified diagnoses of Hemiplegia following CVA (Cerebral Infarction) affecting left non-dominant side, dysarthria, mild cognitive impairment, neoplasm of cerebral meninges, iron deficiency anemia, hypothyroidism, hyperhidrosis, Diabetes type (2), Hypertension (HTN), coronary artery disease (CAD), and wheelchair dependence. The patient was currently prescribed 21 medications including the following 11 medications: hydrocodone, tramadol, codeine, gabapentin, donepezil, morphine, dexamethasone, erythromycin, azithromycin, valsartan, and gemfibrozil. During a review of the patient's medications via drugs.com, there were 15 major interactions identified between the patient's currently prescribed medications. Upon review of the comprehensive assessment on 4/20/2022 under the category of "M2001: Drug Regimen Review," the Registered Nurse who conducted the Start of Care Assessment documented "No issues found during review." MR#9: The SOC was dated 12/12/2021. The POC for the certification period 12/12/2021 to 2/09/2022 identified diagnoses of Hypertensive Heart Disease with Heart Failure (HF), Chronic systolic and diastolic heart failure (CHF), ventricular tachycardia (V-tach), Chronic atrial fibrillation (A-fib), hyperglycemia, and coronary artery disease (CAD). The patient was currently prescribed 23 medications, including Potassium Chloride, Losartan, allopurinol, azathioprine, naproxen, and apixaban. Upon review of the comprehensive assessment on 4/20/2022 under the category of "M2001: Drug Regimen Review,", the Physical Therapist who conducted the Start of Care Assessment documented "No issues found during review." However, a drug review via drugs.com identified 3 major drug interactions. There were no indications that the Physical Therapist had contacted the physician to report the above major interactions that could negatively affect the outcome for this patient diagnosed with congestive heart failure, atrial fibrillation, ventricular tachycardia, hyperglycemia, and coronary artery disease.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the transfer summaries were complete, detailed, and provided the patient's current health status at the time of transfer/discharge, progress toward goals, and forwarded to the receiving facility and the Physician in 1 (MR#'s 11 and 15) of 2 records in which the patient was transferred from the Agency's services, from a total of 17 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: Policy: "Transfer/Referral Criteria" 9.29.1 (Revised March 2018) stated, "A written Transfer Summary concerning the Agency's involvement with the patient, e.g., patient condition at transfer, lab data, patient outcomes in meeting goals in the plan of care, instructions/referrals provided to patient... any continuing symptom management needs, e.g., pain, nausea or dyspnea, and reasons for transfer or referral will be completed." MR#11: This patient was admitted to the agency on 3/9/22 with diagnoses of heart failure, shortness of breath, and pressure ulcer of left buttock-stage 2. On 4/20/22, review of the clinical record noted the patient went from no edema (swelling) in the lower legs on 3/28/22, to 2+ (moderate) edema with shortness of breath with minimal activity on 3/30/22 while taking 40 mg. of lasix (diuretic medication). The patient was transferred to the hospital on 4/10/22 for a 6-day in-patient admission due to fluid overload. Subsequent review of the "Transfer Summary" (dated 4/10/22), which was completed by the Physical Therapist (PT) documented the following under the section titled "Summary of Care"; "Patient during this PT episode improved in areas of LE strength, balance, and gait indep. Patient had PT and SN during this episode." (sic) There were no diagnoses, vital signs, current change in health status, or any information that detailed what the patient's symptoms were that required the transfer with resultant hospitalization. Further, the Transfer Summary failed to document where and when it was sent. These findings were reviewed and acknowledged by the Chief Operations Officer (COO#1) during an interview on 4/21/22 at 1:18 PM. COO#1 stated, "This transfer summary doesn't tell me what the patient's health status was prior to transfer, especially given the recent changes in edema. It's incomplete."

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 document review and interview, it was determined that the agency failed to ensure the plan of care included patient specific objectively measurable goals and outcomes in 4 of a total of 17 sampled records reviewed (MR#s 6, 7, 8, and 10), resulting in difficulty determining the patient's progress toward the achievement of goals (See G572); failed to ensure the Plan of Care covered all pertinent interventions with reportable parameters and measurable goals for 9 (MR#'s 1, 2, 4, 6, 9,11,12, 16, and 17 ) of 16 records reviewed with skilled nursing ordered (See G574); failed to ensure home health aide services were provided as ordered by the physician for 1 (MR#15) of 7 records reviewed with home health aide services, and failed to ensure wound care was provided as ordered by the physician for 1 (MR # 16) of 2 records reviewed in which the primary diagnoses included pressure ulcers (SeeG578); failed to ensure the physician was notified of significant changes in the patient's condition in 1 (MR #11) of 5 records reviewed with congestive heart failure, 1 (MR #1) of 1 record of a patient with elevated blood pressure readings, 1 (MR #2) of 1 record of a patient with a newly opened wound, and for 1 (MR #16) of 1 records reviewed with significant changes in wound status and patient weight (See G590); failed to ensure care was coordinated to meet the patient's needs in 1 (MR# 11) of 16 records reviewed with multiples disciplines assigned (See G608); and failed in 2 (MR#'s 1 and 4) of 2 patients observed during home visits, with a Medication Profile that included the names, dosages and frequencies of the patient's prescribed medications, in plain language (See G616). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.60 Care Planning, Coordination, Quality of Care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included patient specific objectively measurable goals and outcomes in 4 of a total of 17 sampled records reviewed (MR#s: 6, 7, 8, and 10), resulting in difficulty determining the patient's progress toward the achievement of goals. Findings included: **Agency policy: The Plan of Care policy did not address measurability of goals. MR#6: The Start of Care (SOC) was dated 4/12/2022. The Plan of Care (POC) for the Certification Period 4/12/2022 to 6/10/2022 identified diagnoses of Fracture of Femur (FX Femur), Left artificial hip joint, Diabetes type 2 (DM2), Hypertension (HTN), and Atrial Fibrillation (A-Fib). Upon review of the POC, the goals on the POC were not objectively measurable to determine the patient's progress towards goals. Examples include: "Skin tear to right dorsal forearm will heal in 4 weeks; the patient will have no hospitalizations during the certification period; patient will be free from signs and symptoms of hypo/hyperglycemia during the episode." These goals are not objectively measurable to determine the patient's progress towards goals. MR#7: The (SOC) was dated 3/16/2022. The Plan of Care for the certification period of 3/16/22 to 5/14/2022 identified a primary diagnosis of Unilateral primary osteoarthritis of the right knee and secondary diagnoses of mild cognitive impairment, history of Transient Ischemic Attack (TIA), and hypotension. Upon review of the POC, the goals on the POC were not objectively measurable to determine the patient's progress towards goals. Examples include: "Patient will be free of complications of hypotension during episode; Patient/Caregiver will verbalize understanding of individualized emergency plan by end of visit; Patient will verbalize understanding of individualized emergency plan by end of visit." These goals are not individualized or objectively measurable to determine the patient's progress towards goals. MR#8: The Start of Care was dated 3/24/2022, The POC for the certification period 3/24/2022 to 5/22/2022 identified diagnoses of Hemiplegia following CVA (Cerebral Infarction) affecting left non-dominant side, dysarthria, mild cognitive impairment, neoplasm of cerebral meninges, iron deficiency anemia, hypothyroidism, hyperhidrosis, Diabetes type (2), Hypertension (HTN), coronary artery disease (CAD), and wheelchair dependence. Upon review of the POC, the goals on the POC were not objectively measurable to determine the patient's progress towards goals. Examples include: "Patient will be free from signs and symptoms of hypo/hyperglycemia during the episode; patient will be free from injury during the cert period; the caregiver will verbalize understanding of proper diabetic foot care. Physical Therapist will evaluate the need for assistive device/adaptive equipment and recommend appropriate DME (durable medical equipment." These goals are not individualized or objectively measurable to determine the patient's progress towards goals. MR#10: The SOC was dated 3-17-2022. The POC for the certification period 3/17/2022 to 5/15/2022 identified diagnoses of Parkinson's Disease, History of falling, Alcohol abuse, Obstructive Sleep apnea, and Personal History of Nicotine dependence. Upon review of the POC, the goals on the POC were not objectively measurable to determine the patient's progress towards goals. Examples include: "Patient will improve ability to safely transfer from shower to shower with SBA (stand by assist) to allow patient to improve functional mobility and ADLs; To decrease pain to enable patient to perform ADLs (activities of daily living) and IADLs (instrumental activities of daily living) pain free and efficiently." These goals are not individualized or objectively measurable to determine the patient's progress towards goals.

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 record review and interview, the agency failed to ensure the plan of care covered all pertinent interventions with reportable parameters and measurable goals for 9 (MR's #1, 2, 4, 6, 9, 11, 12, 16, and 17) records, from a total of 17 sampled records reviewed, resulting in patients not receiving care specific to their individual needs and poor patient outcomes. Findings include: MR #1: The patient's start of care (SOC) was 4/3/22 with diagnoses that included Left Hip Replacement and Osteoarthritis. During the record review on 4/19/22 at 8:30 a.m., it was noted that the Plan of Care (POC) was void of Skilled Nursing (SN) interventions to monitor and assess pain, reportable pain parameters, interventions to monitor the patient's left hip incision site. Additionally, there were no associated SN measurable goals to address the identified diagnoses. These findings were reviewed with and acknowledged by the Chief Operations Officer (COO #1) during an interview on 4/20/22 at 3:24 p.m. MR #2: The patient's SOC was 1/28/22 with diagnoses that included Hypertensive Heart & Chronic Kidney disease with Heart Failure, Congestive Heart Failure and acute Respiratory Failure with Hypoxia. During the record review on 4/19/22 at 10:30 a.m. it was noted that the POC was void of interventions, reasonable reportable parameters and goals to address the identified diagnoses. The patient expressed a pain level of 3/10 at the SOC. However, the POC gave instructions to notify the Physician when pain levels reached 9/10. This is an unreasonable parameter that doesn't not meet the needs of the patient. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/20/22 at 3:40 p.m. who reported, "We need to do more training." MR #4: The patient's SOC was 12/4/21. The period of review was 4/3/22 through 4/21/22 with diagnoses that included Cellulitis Bilateral lower legs and Acute on Chronic Congestive Heart Failure. During the record review on 4/19/22 at 2:40 p.m., it was noted that the POC failed to include interventions, reportable parameters and measurable goal to address the above diagnoses. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/21/22 at 9:50 a.m. MR#11: This patient was admitted to the agency on 3/9/22 with diagnoses of heart failure, shortness of breath, and pressure ulcer of left buttock-stage 2. On 4/20/22, review of the referral for home care (dated 3/7/22) noted under "Physical Exam" the following: "Trace edema (swelling) in right lower extremity, 2+ edema in the left lower extremity" Under the referral's "Visit Diagnoses" the following was documented: "Acute chronic congestive heart failure... Daily weights." Review of the Plan of Care (POC) performed by Physical Therapy, noted on 3/9/22 for skilled nursing (SN) to evaluate and treat. The POC on 3/9/22 failed to document any treatments, interventions or goals concerning the patient's congestive heart failure (CHF). On 3/11/22, SN performed an evaluation noting the patient's CHF. However, further review of the clinical record found no evidence that the patient's POC had been updated to incorporate SN's findings during the evaluation. In addition, no evidence was found that the POC had been updated to include any treatments, interventions or goals concerning the patient's CHF primary diagnosis up to when the patient was transferred to the hospital on 4/10/22 due to fluid overload. These findings were reviewed with COO#1 (Chief Operations Officer) during an interview on 4/21/22 at 1:10 PM. COO#1 stated, "There are so many things wrong with this plan of care, I don't know what to say." The Agency failed to ensure the POC met the patient's needs with a resultant poor outcome. MR#12: The patient's SOC date was 12/23/21 with diagnoses that included pressure ulcer of right buttock-stage2, pressure ulcer of left buttock-stage 2, and Parkinson's disease. The 12/23/21 Plan of Care (POC) ordered skilled nursing (SN) at a frequency of 2W4 (twice weekly times four weeks). During clinical record review on 4/20/22, it was noted that the nurse documented the patient's wounds both improved and deteriorated during the episode from 12/23/21 through1/31/22. For example, on 12/23/21, SN documented the right buttock pressure ulcer was 4x2x.2 cm. (length x width x depth) and the left buttock pressure ulcer was 5x2.5x.2 cm. The next 5 SN visits, all wounds were documented as having no open areas. On 1/12/22 and 1/17/22, open wounds were noted again. However, the POC failed to have updates and goals which reflected the ongoing changes concerning the patient's primary diagnosis: pressure ulcers. These findings were reviewed and acknowledged by COO#1 during an interview on 4/21/22 at 1:25 PM. COO#1 stated, "You would think she (registered nurse) would include some goals concerning the main diagnosis, more training is needed on this." MR#16: This 70-year-old patient was admitted to home care on 1/23/22 with a primary diagnosis of diabetes with pressure ulcers on the right heel. During record review on 4/18/22, it was noted that the 1/23/22 plan of care (POC) failed to include measurable nursing goals related to the patient's diagnoses of diabetes and pressure ulcers on the right heel. The POC included the following generic goals for this patient: patient will be free from complications related to high blood pressure, congestive heart failure, and atrial fibrillation during episode; and patient will be free from signs and symptoms of low/high blood sugars during the episode. There was no indication as to how these nursing goals would be objectively measured to determine the patient's progress towards discharge. There were no measurable goals related to the patient's pressure ulcers. The findings were reviewed with and confirmed by the clinical manager (COO#1) during an interview on 4/20/22 at 2:00 p.m. MR#17: This patient was admitted to home care on 12/28/21 with diagnoses of acidosis and altered mental status. During record review on 4/19/22, it was noted that the 12/8/21 POC failed to include measurable goals including goals that were relevant for this patient. The POC included a nursing goal that the patient will be able to identify the correct dose, route, and frequency of each medication by the end of the visit. This patient is 90 years old and resides in an assisted living facility. The medications are passed by facility staff and a patient with a diagnosis of altered mental status is not likely to identify the correct dose, route, and frequency of the 12 medications listed on the plan of care by the end of the visit. The patient was recertified for care on 2/25/22. The 2/26/22 plan of care ordered weekly skilled nursing services for 6 weeks. The recertification POC failed to include skilled nursing interventions and goals. The findings were reviewed with and confirmed by COO#1 during an interview on 4/20/22 at 2:45 p.m. MR#6: The Start of Care (SOC) was dated 4/12/2022. The Plan of Care (POC) for the Certification Period 4/12/2022 to 6/10/2022 identified diagnoses of Fracture of Femur (FX Femur), Left artificial hip joint, Diabetes type 2 (DM2), Hypertension (HTN), and Atrial Fibrillation (A-Fib). This patient was currently prescribed Levemir insulin injections 18 units subcutaneous every morning, along with metformin 1000 mg by mouth every 12 hours. Upon review of the POC, it was noted that there were no reportable parameters to address the patient's diabetic needs. MR#9: The SOC was dated 12/12/2021. The POC for the certification period 2/10/2022 to 4/102022 identified diagnoses of Hypertensive Heart Disease with Heart Failure, Acute on Chronic combined systolic and diastolic heart failure (CHF), ventricular tachycardia (V-tach), and Chronic Atrial Fibrillation (A-Fib). The patient was ordered to receive Physical Therapy (PT) services once a week times 8 weeks. Upon review of the Plan of Care, it was noted there were no interventions to address the patients CHF such as daily weights, or measurement of lower extremity edema. The outcome for this patient was an inpatient hospital admission on 3/15/2022. The reason for the hospitalization was not documented by the Physical Therapist (PT#3). These findings were reviewed with and confirmed by the Chief Operations Officer (COO#1) on 4/21/2022 at 2:00 p.m. After reviewing the record, the COO#1 stated, "we should have had a skilled nurse assigned to the case to monitor the patient's CHF."

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure home health aide services were provided as ordered by the physician for 1 (MR#15) of 7 records reviewed with home health aide services ordered, resulting in a lack of services and the potential for unmet patient needs; and failed to ensure the skilled nurse followed the visit frequency ordered by the physician for 1 of 2 (MR#16) records reviewed in which the primary diagnoses included pressure ulcer. Resulting in wound deterioration and transfer to the hospital for this patient. Findings include: MR#15: This patient was admitted to the Agency on 2/13/22 with diagnoses of Parkinson's disease, chronic kidney disease, and peripheral neuropathy. During the clinical record review on 4/20/22, the physician referral for home care ordered on 1/20/22, the following disciplines to care for the patient: PT (physical therapy), OT (occupational therapy), RN (registered nurse), and HHa (home health aide). It was noted that there was no documented evidence that aide services had been provided to this patient and no documentation that the patient or caregiver had declined aide services. There was no documentation that the physician was informed that aide services were not provided as ordered on the referral. These findings were reviewed and acknowledged by the Chief Operations Officer (COO#1) during an interview on 4/21/22 at 2:10 PM. COO#1 stated, "There needs to be an explanation documented why we didn't follow this order and provide aide services, and I don't see one." MR#16: This 70-year-old patient was admitted to home care on 1/23/22 with a primary diagnosis of diabetes with pressure ulcers on the right heel. The comprehensive assessment on 1/23/22 indicates the patient had an unstageable 3cm x 3 cm (length x width) pressure ulcer on the right heel. The patient's past medical history included a left below the knee amputation. The patient wore a prosthetic leg. The 1/23/22 plan of care ordered the skilled nurse (SN) to provide wound care twice each week for 4 weeks. On 1/27/22, the LPN (licensed practical nurse) visit note indicates that the original wound was closed, and the patient had developed a second wound on the right heel that was unstageable that measures 3 cm x 3 cm x 0 cm (length x width x depth). On 1/31/22, the LPN visit note indicates the second wound was closed and the patient had developed two additional pressure ulcers on the right heel. The third wound was unstageable that measures 3 cm x 3 cm x 0.1 and wound four was not measured and was described as a stage 2 (partial thickness skin loss) pressure ulcer with scant purulent drainage. On 2/4/22, the LPN documents that the third wound had closed and that wound four remained a stage 2 with a depth of 0 cm and scant purulent drainage. On 2/7/22, the LPN notes that wound four remains a stage 2 and measures 0 cm x 0 cm x 0 cm with scant purulent drainage. On 2/11/22, the LPN documents that wound four remains a stage 2 and now measures 2.5 cm x 3.5 cm x 0 cm with scant purulent drainage and a strong odor. The increase in wound size and the strong odor are indications of wound deterioration. On 2/17/22, a physician visits the patient and writes the following orders: "wound care on right heal, cleanse with soap and water or wound cleanser, apply Hydro gel dressing to wound bed, cover heel with nonadherent dressing, secure with Kerlix, change 2 to 3 times a week or PRN per looser (sic) dislodged dressing". On 2/17/22, the registered nurse (RN #3) visits the patient and notes that wound four is stage 2 and measures 4 cm x 4 cm x 0.1 cm with scant serous drainage. RN #3 also notes that Hydrogel is applied to the wound. This indicates that RN #3 is aware of the physician orders that same day, however no additional nursing visits for wound care were documented the week of 2/17/22 as ordered by the physician. On 2/22/22, RN #3 documents wound four is stage 2 and measures 3.5 cm x 3.5 cm x 0.1 cm with scant serous drainage. There are no additional nursing visits documented this week as ordered by the physician. On 3/1/22, RN #3 notes that wound four is unstageable (tissue loss covered by necrotic tissue or eschar and depth cannot be determined, the base of the pressure injury is not visible) and measures 3.5 cm x 3.5 cm x 0.1 cm with scant serous drainage. There are no additional nursing visits documented this week as ordered by the physician. That same day, on 3/1/22 a discharge summary notes that the patient was admitted to the hospital for unknown reasons. On 3/8/22, a transfer summary indicates the patient was hospitalized. On 3/8/22, the physical therapist (PT) documents the patient is transferred to an inpatient facility for wound infection or deterioration. For a three-week period, from 2/17/22 through the day the patient was transferred to the hospital (3/1/22 or 3/8/22) the nurse documents that one visit was provided each week. The agency failed to ensure the nurse followed the visit frequency as ordered by the physician on 2/17/22, which had increased the dressing changes to 2-3 times per week. The lack of additional dressing changes for three weeks most likely contributed to the patient's wound deterioration resulting in a transfer to the hospital. The findings were reviewed with and confirmed by the clinical manager (COO#1) during an interview on 4/20/22 at 2:00 p.m. COO#1 reviewed the medical record and confirmed that the agency had missed the 2/17/22 physician orders and failed to ensure that dressing changes were done 2-3 times per week as ordered by the physician.

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 observation, record review and interview, the agency failed to ensure the physician was notified of significant changes in the patient's condition in 1 (MR #11) of 5 records reviewed with congestive heart failure, 1 (MR #1) of 1 record of a patient with elevated blood pressure readings, 1 (MR #2) of 1 record of a patient with a newly opened wound, and for 1 (MR #16) of 1 records reviewed with significant changes in wound status and patient weight, from a total sample of 17 records reviewed, resulting in poor patient outcomes. Findings include: MR #1: The patient's start of care (SOC) was 4/3/22 with diagnoses that included Left Hip Replacement and Osteoarthritis. On 4/18/22 at 3:10 p.m. during a scheduled home visit was conducted with the Licensed Practical Nurse (LPN #1). Prior to the visit, LPN #1 reported that the patient's blood pressure has been elevated since her surgery (3/14/22). During the visit, the patient's admission pack was reviewed and revealed a blood pressure reading of 158/88 from the initial start of care visit. there were no other entries on the sheet. LPN #1 checked the patient's blood pressure and got a reading of 141/105 (outside/above the reportable parameters). LPN #1 then stated, "I'll check it again before I leave." During the visit, the patient stated that her blood pressure was also elevated on 4/15/22 with a reading of 149/118, again, outside the reportable parameters in which to notify the Physician. On 4/19/22 at 8:30 a.m., during the record review, it was noted that the Plan of Care (POC) listed the following reportable blood pressure parameters: Notify physician of: Systolic BP greater than (>) 160 or less than ()90 or less than (There was no evidence the LPN communicated this significant change in wound status to the physician, or the registered nurse, or to the agency. The patient was transferred to the hospital on 3/1/22 due to wound due to wound infection or deterioration. The findings were reviewed with and confirmed by the clinical manager (COO#1) during an interview on 4/20/22 at 2:00 p.m. COO#1 reviewed the medical record and confirmed that the LPN had not reported the weight gain or the changes in wound status to the physician. MR#11: This patient was admitted to the agency on 3/9/22 with diagnoses of heart failure, shortness of breath, and pressure ulcer of left buttock-stage 2. On 4/20/22, review of the referral for home care (dated 3/7/22) noted under "Physical Exam" the following: "Trace edema (swelling) in right lower extremity, 2+ edema in the left lower extremity" Under the referral's "Visit Diagnoses" the following was documented: "Acute chronic congestive heart failure... Daily weights." In addition, the patient's weight was documented (in the face to face assessment?) as 139 lbs. Review of initial comprehensive assessment (3/9/22) performed by the physical therapist (PT), noted the patient's weight was 190 lbs. along with 2+ pitting edema in both lower legs. PT further noted the patient had shortness of breath (SOB) with moderate activity. The Plan of Care (POC) ordered on 3/9/22 for Skilled Nursing (SN) to evaluate and treat the patient. On 3/11/22, SN performed the evaluation with an accompanying visit frequency order of 1W2 (once a week times 2 weeks) and 2W4. In addition, SN was to assess the patient's weight every visit. The SN evaluation had documented the patient had no edema but was SOB with minimal exertion. No patient weight was found within the SN evaluation. Further review of the medical record noted SN performed 8 visits from 3/11/22 through 4/6/22, with no evidence of any documented patient weights. The first five visits (3/11/22 through 3/28/22) documented the patient had no edema. However, SN documented on 3/30/22, the patient had bilateral lower leg edema of 2+ and was SOB with minimal exertion. The next two visits on 4/4/22 and 4/6/22 documented 2+ and 1+ bilateral lower leg edema respectively with SOB with minimal exertion. The patient was transferred to the hospital on 4/10/22 for a 6 day in-patient admission due to fluid overload. No evidence was found that SN had notified the physician concerning the significant changes in the patient’s condition on 3/30/22 through 4/6/22, or had coordinated care with other skilled team members on the case. These findings were reviewed with COO#1 (Chief Operations Officer) during an interview on 4/21/22 at 1:06 PM. COO#1 stated, "This is inexcusable, this should have been prevented." The Agency failed to alert the physician when SN's failure to recognize the deterioration of the signs and symptoms associated with the patient’s primary diagnosis resulted in a 6-day hospital admission.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to coordinate the delivery care concerning skilled nursing (SN), physical therapy (PT), and physician in 1 (MR#11) of 16 records reviewed in which more than one discipline was ordered to provide care out of a total of 17 records reviewed, resulting in unmet clinical care needs and a poor outcome for this patient. Findings include: MR#11: This patient was admitted to the agency on 3/9/22 with diagnoses of heart failure, shortness of breath, and pressure ulcer of left buttock-stage 2. On 4/20/22, review of the referral for home care (dated 3/7/22) noted under "Physical Exam" the following: "Trace edema (swelling) in right lower extremity, 2+ edema in the left lower extremity. Pea sized open stage 2 pressure injury, left buttock near gluteal fold..." Under the referral's "Visit Diagnoses" the following was documented: "Primary: Acute chronic congestive heart failure... Daily weights." In addition, the patient's weight was documented as 139 lbs. The referral ordered Physical Therapy (PT) for gait abnormality. Review of the clinical record found no explanation why the patient who had significant acute medical care needs had PT open the case instead of skilled nursing (SN). Review of initial comprehensive assessment (3/9/22) performed by the physical therapist (PT), noted the patient's weight was 190 lbs. (51 lbs. weight gain since referral visit) along with 2+ pitting edema in both lower legs. PT further noted the patient had shortness of breath (SOB) with moderate activity. No documentation was found in the clinical record of the PT and SN discussing and coordinating patient care needs/concerns identified from the referral and the start of care assessment. The Plan of Care (POC) ordered on 3/9/22 for Skilled Nursing (SN) to evaluate and treat the patient. On 3/11/22, SN performed the evaluation with an accompanying visit frequency order of 1W2 (once a week for 2 weeks) and 2W4. In addition, SN was to assess the patient's weight every visit. The SN evaluation had documented the patient had no edema but was SOB with minimal exertion. No patient weight was found within the SN evaluation. Further review of the medical record noted SN performed 8 visits from 3/11/22 through 4/6/22, with no evidence of any documented patient weights. The first five visits (3/11/22 through 3/28/22) documented the patient had no edema. However, SN documented on 3/30/22, the patient had bilateral lower leg edema of 2+ and was SOB with minimal exertion. The next two visits on 4/4/22 and 4/6/22 documented 2+ and 1+ bilateral lower leg edema respectively with SOB with minimal exertion. The patient was transferred to the hospital on 4/10/22 for a 6-day in-patient admission due to fluid overload. No evidence was found that SN had coordinated care with the physician concerning the significant changes in the patient’s condition on 3/30/22 through 4/6/22 or had coordinated care with other skilled team members on the case. These findings were reviewed with COO#1 (Chief Operations Officer) during an interview on 4/21/22 at 1:06 PM. COO#1 stated, "This is inexcusable, this should have been prevented." The Agency's intake coordinator, PT, SN, and administrative oversight failed to coordinate efforts to ensure the patient's clinical needs were appropriately met, resulting in a 6-day hospital admission.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined that the agency failed to provide 2 (MR#'s 1, 4) of 2 patients observed during home visits, with a Medication Profile that included the names, dosages and frequencies of the patient's prescribed medications, in plain language, from a total of 17 sampled records reviewed, resulting in lack of direction for medication administration and the potential for improper use of medications. Findings include: MR #1: The patient's start of care (SOC) was 4/3/22 with diagnoses that included Left Hip Replacement. On 4/18/22 at 3:10 p.m., a joint survey home visit was conducted with the Licensed Practical Nurse (LPN #1). During a review of the patient's admission packet, it was noted that there was no Medication Profile that listed the patient's prescribed medications, dosages and side effects. These findings were reviewed with and acknowledged by the Chief Operations Officer (COO #1) during an interview on 4/20/22 at 3:24 p.m. MR #4: The patient's SOC was 12/4/21. The period of review was 4/3/22 through 4/21/22 with diagnoses that included Cellulitis Left Lower leg and Acute on Chronic Congestive Heart Failure. A joint home visit was conducted with the Home Health Aide on 4/20/22 at 8:30 a.m. During a review of the patient's admission packet, it was noted that there was no Medication Profile in the patient's folder that listed the patient's prescribed medications, dosages and side effects. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/21/22 at 9:50 a.m.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the Governing Body failed to ensure the agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section, that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all patients receiving services. Findings include: During review of the agency's QAPI program on 4/21/22 at 1:00 p.m., it was discovered that no annual program evaluation was documented for 2019, 2020 or 2021. During an interview on 4/21/22 at 3:15 p.m., the Chief Operations Officer/Clinical Manager (COO#1) acknowledged the above findings.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined that the agency (HHA) failed to ensure its disciplines utilized Infection Control standards of practice during the provision of care (G-682), and failed to provide documented evidence that infection control education was provided to all staff (G-686), in 3 of 8 employee files (MSW #1, LPN #2 and RN #2) reviewed, from a total of 8 employee files reviewed, resulting in the potential for the spread of infection. Findings include: 1. G-682: Infection control prevention. 2. G-686: Infection control education.

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 observation, interview and record review, the Agency failed to ensure its disciplines utilized Infection Control standards of practice during the provision of care and services for 2 (MR's 1,4) of 2 patients observed during home visits from a total of 17 sampled records reviewed, resulting in the potential for the development and spread of infection. Findings include: MR #1: The patient's start of care (SOC) was 4/3/22 with diagnoses that included Left Hip Replacement. On 4/18/22 at 3:10 p.m., a joint survey home visit was conducted with the Licensed Practical Nurse (LPN #1). During the visit, LPN #1 assessed the vital signs (blood pressure, temperature, oxygen saturation). After checking the patient's blood pressure, LPN #1 placed her stethoscope around her neck. LPN #1 did not clean her equipment prior to placing it around her neck. LPN #1 then placed the unit used to check the patient's oxygen level in her back without sanitizing it first. Additionally, prior to leaving, LPN #1 dropped her digital thermometer on the floor, picked it up and placed it in her work back. LPN #1 did not sanitize the thermometer prior to placing it in her bag. LPN #1 failed to utilize Infection Control standards of practice. These findings were reviewed with and acknowledged by the Chief Operations Officer (COO #1) during an interview on 4/20/22 at 3:24 p.m. MR #4: The patient's SOC was 12/4/21. The period of review was 4/3/22 through 4/21/22 with diagnoses that included Cellulitis Left Lower leg and Acute on Chronic Congestive Heart Failure. A joint home visit was conducted with the Home Health Aide (HHa #1) on 4/20/22 at 8:30 a.m. During the home visit, HHa #1 retrieved 2 basins (One for soapy water and one to rinse the soap from the patient's body) in order to give the patient a bed bath. During the bath, it was note that HHa #1 never changed/refreshed the dirty water used to bathe the patient. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/21/22 at 9:50 a.m. who reported, "I've given this man (patient) a bath before myself. There should be 2 basins of water. One is clean and one is dirty. The water has to be changed out." The Agency personnel failed to utilize Infection Control standards of practice during the provision of care.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency (HHA) failed to provide documented evidence that infection control education was provided to all staff employed by the agency and who were granted clinical privileges, resulting in the potential for the development and spread of infection. Findings include: During review of the agency's employee files on 4/21/22 at 11:00 a.m., it was discovered that 3 employee files (MSW#1, LPN#2, and RN#2), from a total of 8 files reviewed, failed to document initial infection control training. During an interview on 4/21/22 at 3:15 p.m., the Chief Operations Officer/Clinical Manager (COO#1) acknowledged the above findings.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: The Immediate Jeopardy (IJ) began on 2/16/22 The IJ was identified on 4/19/22 The Chief Executive Officer (CEO #1) and Chief Operations Officer (COO #1) were notified of the IJ in person and by email on 4/21/22 at 10:46 a.m. A Plan to remove the immediacy was requested. The Immediacy/IJ was removed on 4/21/22 at 2:18 p.m., based on an acceptable plan of removal which was approved by the State Agency. Although the IJ was removed on 4/21/22, the cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR §484.75 Skilled Professional Services. Based on record review and interview, the Agency failed to ensure the Skilled Nurse performed baseline assessments and reassessments, including monitoring patient's weight and measurable assessments of edema for 2 (MR #2, 4) of 5 patients with diagnoses that included Congestive Heart Failure, from a total of 17 sampled records reviewed. This resulted in Immediate Jeopardy (IJ) to the health and safety of MR #2 as a result of failure to provide initial and ongoing assessments of the patient's weight, measurable edema and declining oxygen status resulting in the patient experiencing difficulty breathing with resultant hospitalization due to cardiac arrest. This deficient practice resulted in MR #5's subsequent death (G706); failed to ensure the clinical record was complete and included detailed Skilled Nursing and Occupational Therapy notes for 1 (MR #2) of 1 record where the ordered disciplines communicated the status of the patient's declining health utilizing a Text messaging system, from a total of 17 sampled records reviewed, resulting in lack of continuity of care, undocumented health concerns, and unmet urgent patient care needs (G716); and failed to ensure the registered nurse supervised the care of the licensed practical nurse for 1 of 17 (MR #17) records reviewed (G724). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.75 Skilled Professional Services.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Skilled Nurse performed baseline assessments and reassessments, including monitoring patient's weight and measurable assessments of edema for 2 (MR #2, 4) of 5 patients with diagnoses that included Congestive Heart Failure, from a total of 17 sampled records reviewed. This resulted in Immediate Jeopardy (IJ) to the health and safety of MR #2 as a result of failure to provide initial and ongoing assessments of the patient's weight, measurable edema and declining oxygen status resulting in the patient experiencing difficulty breathing with resultant hospitalization due to cardiac arrest. This deficient practice resulted in MR #5's subsequent death. Findings Include: Policy: "Initial Assessments/Comprehensive Assessments" March 2018, 9.6.1 stated, "Each patient admitted will receive a comprehensive assessment. The assessment will reflect the patient's current health status and include information to demonstrate the patient's progress toward achievement of desired goals..., Physical assessment/review of systems and pertinent physical findings..." Policy: "Nursing Services" March 2018 9.16.1 stated, "Patients receiving nursing services will have appropriate assessments, reassessments, care planning and established outcomes performed." On 4/18/22 at 10:32 a.m. during the Entrance Conference, the Chief Operations Officer (COO #1) was queried about the protocol for management of the patient with Congestive Heart Failure and responded, "We use the patient’s scales to obtain the patient's weight. We do Calf, ankles and arch measurements. I'm an old school Nurse so I do a lot of teaching on dyspnea (shortness of breath) and edema. Information is also provided to the patient and caregiver." MR #2: The patient's start of care (SOC) was 1/28/22 with diagnoses that included Congestive Heart Failure, Hypertensive Heart & Chronic Kidney Disease with Heart Failure, Acute Respiratory Failure and Pressure Ulcer right buttock. The clinical record review was conducted on 4/19/22 at 10;30 a.m. and revealed the following: The referral for home care dated 1/27/22 ordered Skilled Nursing and Therapy services to be provided and documented that the patient "presented to the hospital on 1/20/22 with shortness of breath, bilateral lower extremity edema, elevated Troponin (cardiac enzyme indicative of heart damage) suspect a component of heart failure..." The Plan of Care (POC) listed diagnoses Congestive Heart Failure, Hypertensive Heart & Chronic Kidney Disease with Heart Failure, Acute Respiratory Failure with Hypoxia and Pressure Ulcer right buttock and documented "Skilled observation/evaluation/assessment of disease process and/or progression. Instruct and supervise on disease process and/or complications, assessment of patient with hypertensive & chronic kidney disease with heart failure, congestive heart failure..." The POC was void of any interventions to monitor/assess the patient's weight or edema. The Initial Comprehensive Assessment dated 1/28/22, completed by the Registered Nurse (RN #1) failed to include a baseline measurement of edema. The section that the addressed the patient's weight was left blank. Section M1060 "Height and Weight" documented, "Not assessed." The section titled "Cardiovascular" documented, "Edema: - Bilateral LE (lower extremity) Edema 1+, however RN #1 documented, "Patient denies LE edema measurement..." A review of the Skilled Nurse (SN) visit notes revealed the following: 1/28/22 - No baseline weight, No measurement of edema. 2/2/22 - "Unable to obtain vital signs. Telehealth Visit." However, the nurse documented Bilateral LE 1+. 2/4/22 - No weight obtained, No objective measurement of edema. The nurse documented 1+ edema. 2/9/22 - No weight obtained, No objective measurement of edema. The nurse documented 2+ edema. 2/11/22 - No weight obtained, No objective measurement of edema. The nurse documented 1+ edema. An Occupational Therapy (OT #1) note dated 2/14/22 documented, "...oxygen level was at 80% at rest earlier and wife increased oxygen to 2.5L..." An OT "Patient Communication" note dated 2/14/22 documented, "Pt's oxygen levels dropping below 90 and going back up since 9/11/22 [sic]. Wife increased oxygen from 2L-2.5L..." There was no documented evidence that a Nurse followed up to assess the patient's oxygen status. Further, there was no documented evidence that OT #1 followed up with the patient to assess his reported decreased oxygen levels. A "Transfer Summary" documented by OT #1 dated 2/16/22 revealed that the patient was subsequently transferred to the hospital due to cardiac arrest (The heart stops beating). No onsite visit had been made to the patient's home to assess his cardiac status or oxygen levels since the reported decline in oxygen saturation on 2/14/22. A document titled, "30-Day Summary" dated 2/20/22, completed by the Registered Nurse (RN #1) documented, "Patient ended up passing away in the hospital." An interview was conducted with COO #1 on 4/20/22 at 3:40 p.m. During the interview, when queried about the findings in the SN notes, COO #1 reported, "The patient should have been weighed on admission and continuous monitoring as this patient is a cardiac case. There should have been measurements for edema. I ordered these tape measurers (COO #1) produced a pocket tape measure as example of what disciplines were provided) for the disciplines. Increased weight and edema could be a sign of exacerbation of the patient's health condition. I teach this all the time." When queried about the OT Communication note dated 2/14/22 regarding the patient's reported oxygen levels, COO #1 stated, "She (OT #1) should have made it a priority to get a nurse involved to assess the patient for cardiac and respiratory exacerbation. When you have kidney and cardiac disease, one of the systems will show signs of distress. You’ll see it in the heart or the lungs. This patient needed to be assessed. He needed help. Oxygen, cardiac meds or something. We as nurses had a responsibility to see the patient. The OT communicated via Tiger Connect (Text messaging system). In these circumstances, OT #1 should have called someone instead of using Tiger Connect. On the 16th the patient was transferred to the hospital by the OT and at this point, I don’t know that the sense of urgency was relayed. The patient needed to be assessed. I personally feel like we dropped the ball." On 4/21/22 at 10:18 a.m., an interview was conducted with the assigned Registered Nurse (RN #1). When queried about the care of the patient and the patient's status at the time of transfer to the hospital RN #1 reported, "I admitted the patient. I'm a new nurse. My family was going through a lot and getting over Covid, so I was backed up with paperwork. It was an honest mistake not to get the baseline data. It just slipped my mind." When asked if he followed up with the patient once notified by OT #1 of decreased oxygen levels, RN #1 responded, "I don't recall. If OT #1 contacted me, she would have used Tiger Text or phone. Unfortunately, Tiger Text gets deleted every 30 to 45 days. It’s an auto-delete thing.” The Agency failed to ensure the patient was adequately assessed and reassessed as his condition warranted. MR #4: The patient's SOC was 12/4/21. The period of review was 4/3/22 through 4/21/22 with diagnoses that included Cellulitis Bilateral lower legs and Acute on Chronic Congestive Heart Failure. During the record review on 4/19/22 at 2:40 p.m., it was noted that the POC order the patient to receive Skilled Nursing (SN) services at a frequency of 1x/wk. x 4 wks., 4 prn (as needed) visits and documented, "Assessment of patient with Cellulitis right/left lower limb, Acute on chronic diastolic (Congestive) heart failure." Further review of the clinical record revealed that the SN visit notes dated 4/5/22 and 4/12/22 were void of the patient's weight or any measurement in accordance with acceptable standards of practice. Additionally, the SN failed to measure the patient's extremity circumference as a measurable assessment of edema. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/21/22 at 9:50 a.m.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the clinical record was complete and included detailed Skilled Nursing and Occupational Therapy notes for 1 (MR #2) of 1 record where the ordered disciplines communicated the status of the patient's declining health utilizing a Text messaging system, from a total of 17 sampled records reviewed, resulting in lack of continuity of care, undocumented health concerns, and unmet urgent patient care needs. Findings include: Policy: "Reassessments/Update of the Comprehensive Assessment" March 2018, 9.7.2 stated, "Each patient will have appropriate reassessments performed and documented." Policy: "Medical Record Content" March 2018 11.1.1 stated, "The Agency will initiate and maintain an individual and accurate medical record for each patient receiving care in compliance with all federal/state laws and regulations. The Agency will use a standardized format for medical records." MR #2: The patient's start of care (SOC) was 1/28/22 with diagnoses that included Hypertensive Heart & Chronic Kidney Disease with Heart Failure, Congestive Heart Failure (CHF), Acute Respiratory Failure and Pressure Ulcer right buttock. On 4/19/22 at 10:30 a.m. the clinical record review revealed the following: A "Patient Communication" note dated 2/14/22 documented, "Pt's oxygen levels dropping below 90 and going back up since 9/11/22 [sic]. Pt's wife increased oxygen from 2L-2.5L. PCP, supervisor, SN, and PT notified on this date. PCP reported no new orders." There was no documentation of the patient's actual oxygen levels. On 4/20/22 at 3:40 p.m. during an interview, the Chief Operations Officer (COO #1) was queried about the above note. When asked of this was an onsite visit conducted by the Occupational Therapist (OT #1), COO #1 reported, "I'm not sure and I don't know how she (OT #1) even got this information as there is no visit note attached to it. She was communicating via "Tiger Text" (form of text messaging)." Further review revealed a Transfer Summary dated 2/16/22 authored by OT #1 which documented that the patient was transferred to the hospital for Cardiac Arrest." The next correspondence would be a document titled, "30-Day Summary" dated 2/20/22 which documented, "Patient ended up passing away in the hospital." The clinical record was unclear as to the events that transpired leading to the patient's hospitalization and subsequent death. On 4/21/22 at 10:15 a.m., COO #1 stated that the Registered Nurse (RN #1) involved in the case was present and available for interview. At 10:18 a.m., during an interview, RN #1 was queried about documentation of the events leading to the patient's hospitalization and subsequent death and reported, "I admitted the patient. I'm a new nurse and my family was getting over Covid, so I was backed up with paperwork. It was an honest mistake..." When asked if he (RN #1) had been made aware of the patient's oxygen levels dropping, as stated in the previous communication by OT #1, RN #1 reported, "I don't recall. If OT #1 contacted me, she would have used Tiger Text or telephone. Unfortunately, Tiger Text gets deleted every 30 days. It's an auto-delete thing. I don't think I documented that conversation." The Chief Executive Officer (CEO #1), who was present during the interview interjected and stated, "RN #1 was quite backed up at the time. He had past due documents. As for Tiger Text, it does disappear. Unfortunately, the OT (OT #1) had issues with documentation early on." When asked for an opportunity to interview OT #1, COO #1 stated, "She is declining to speak with the State." The Occupational Therapist and Registered Nurse failed to ensure the clinical record was complete and included documentation of the events that lead to the patient's hospitalization with resultant death. These findings were reviewed with and acknowledged by the Chief Executive Officer/Administrator (CEO #1) and COO #1 who were both present during the interview.

Supervise skilled professional assistants CFR(s): 484.75(c) Standard: Supervision of skilled professional assistants. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse supervised the care of the licensed practical nurse for 1 of 17 (MR #17) records reviewed, resulting in a lack of oversight regarding the services provided by the licensed practical nurse. Findings include: During the entrance conference on 4/18/22 at 10:00 a.m., COO #1 (clinical manager) stated that licensed practical nurses (LPN) are supervised by a registered nurse (RN) and this is documented in the skilled nursing visit notes every 30 days. MR#17: This patient was admitted to home care on 12/28/21 with diagnoses of acidosis and altered mental status. The patient was recertified for care on 2/25/22. The 2/26/22 plan of care ordered once weekly skilled nursing care for six weeks. The patient developed a pressure ulcer on the left buttock on 2/28/22.On 3/4/22, the physician ordered twice weekly skilled nursing visits for five weeks. On 4/5/22,a physician order continued the twice weekly skilled nursing care for an additional 3 weeks. During record review on 4/19/22, it was noted that the LPN provided nursing care for a 49-day period (from 2/28/22 through 4/18/22) without any documented evidence of supervision or oversight by the RN. The finding was reviewed with and confirmed by COO#1 during an interview on 4/20/22 at 2:45 p.m.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure the Registered Nurse (RN) prepared clear written patient care instructions for the Home Health Aide regarding safety precautions and client needs, prior to providing care in 3 (MR's #1, 2, 4) of 7 records in which Home Health Aide services were provided, from a total of 17 sampled records reviewed, resulting in the potential for the provision of unsafe care and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 4/3/22 with a diagnosis of Left Hip Replacement. The Plan of Care (POC) ordered Home Health Aide (HHa) services at a frequency of 2x/wk. x 6 wks. and listed the following: Safety Measures: slow position change, support during transfer and ambulation, seizure precautions, proper position during meals, Fall Precautions. During the clinical record review on 4/19/22 at 8:30 a.m., it was noted that the "Aide Care Plan" dated 4/8/22 was void of the above noted precautions. These findings were reviewed with and acknowledged by the Chief Operations Officer (COO #1) during an interview on 4/20/22 at 3:24 p.m. MR #2: The patient's SOC was 1/28/22 with diagnoses that included Hypertensive Heart Disease with Heart Failure and Congestive Heart Failure and Pressure Ulcer right buttock. During the record review on 4/19/22 at 10:30 a.m., it was noted that the POC order HHa services at a frequency of 1x/wk. x 4 wks. The POC listed: Safety Measures Slow position change, O2 (oxygen) precautions, support during transfer and ambulation, Anticoagulant (bleeding) precautions, proper position during meals, Fall precautions..." The Aide Care Plan was void of the aforementioned safety precautions. These findings were reviewed with COO #1 during an interview on 4/20/22 at 3:40 p.m. MR #4: The patient's SOC was12/4/21. The period of review was 4/3/22 through 4/21/22 with diagnoses that included Cellulitis Left/Right Lower Leg, Acute on Chronic Congestive Heart Failure (CHF), Diabetes Mellitus and Obesity. During the record review on 4/19/22 at 2:40 p.m., it was noted that a Physician's order dated 4/6/22 ordered HHa services at a frequency of 2x/wk. x 4 wks. The POC listed: Safety Measures: Keep side rails up, Slow position change, O2 (oxygen) precautions, support during transfer and ambulation, proper position during meals, Fall precautions..." The Aide Care Plan was void of the aforementioned safety precautions. On 4/20/22 at 8:30 a.m., a schedule home visit was conducted with the Home Health Aide (HHa #1). During the visit, the patient was observed to have an overhead Trapeze, (used for mobility), Reacher, and a continuous breathing apparatus (Respironics (name brand) non-invasive ventilator. These items had not been included on the Aide Care Plan. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/21/22 at 9:50 a.m.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the Agency failed to ensure the Home Health Aide provided care in accordance with the written plan of care for 1 (MR #4) of 1 patient observed during a Home Health Aide home visit, from a total of 17 sampled records resulting in the patient not receiving care and services as ordered and unmet care needs. Findings include: MR #4: The patient's start of care (SOC) was 12/4/21. The period of care reviewed was 4/3/22 through 4/21/22 with diagnoses that included Cellulitis bilateral lower extremities, Acute on Chronic Congestive Heart Failure, Diabetes Mellitus and Obesity. On 4/19/22 at 2:40 p.m., during a review of the clinical record, it was noted that the "Aide Care Plan" dated 12/4/21 ordered the following tasks to be performed each visit: shampoo hair, shave, comb hair, oral hygiene - denture care. On 4/20/22 at 8:30 a.m., during a scheduled home visit with the Home Health Aide (HHa #1) the following was observed: HHa #1 checked the patient's vital signs, gave the patient a bed bath, assisted with toileting, repositioning and a partial linen change. HHa #1 failed to provide the additional aforementioned tasks as ordered in the Aide Care Plan. Further, HHa #1 did not offer to provide the ordered services, nor did the patient decline to receive the ordered services. The Aide failed to provide care and services in accordance with the plan of care. These findings were reviewed with and acknowledged by the Chief Operations Officer (COO #1) during an interview on 4/21/22 at 9:50 a.m.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency (HHA) failed to ensure employee qualifications were documented in the employee's files for 4 of 8 employee files (MSW #1, OT #2, LPN #2 and RN #2) reviewed, from a total of 8 employee files reviewed, resulting in the potential for care being provided by unqualified personnel. Findings include: During review of employee files on 4/21/22 at 11:00 a.m., it was discovered that the medical social worker (MSW #1) had no orientation or in-services documented in their employee file. The occupational therapist (OT#2) had no in-services documented in their employee file. The licensed practical nurse (LPN #2) had no orientation or in-services documented in their employee file. The registered nurse (RN #2) had no orientation documented in their employee file. During an interview on 4/21/22 at 3:15 p.m., the Chief Operations Officer/Clinical Manager (COO#1) acknowledged the above findings.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the speech therapist documented clinical notes for 1 of 3 (MR#17) records reviewed with speech therapy services, resulting in a lack of information regarding the care provided by speech therapy and the patients progress towards therapy goals. Findings include: MR#17: This patient was admitted to home care on 12/28/21 with diagnoses of acidosis and altered mental status. The patient was recertified for care on 2/25/22. The speech therapist (ST) evaluated the patient on 3/25/22. The evaluation notes that the patient requires additional ST services twice a week for two weeks. During record review on 4/19/22, it was noted that the clinical record contained only the ST evaluation, there were no additional ST visit notes for review. During the entrance conference on 4/18/22 at 10:00 a.m., COO #1 (clinical manager) stated that the agency expects visit notes to be completed within 48 hours of the visit, however staff have up to 7 days to complete their visit notes. The ST visit notes were not completed within the agency's expected timeframes. The ST notes were not available for review during record review on 4/19/22.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to insure a detailed discharge summary was sent to the physician within 5 business days of discharge for 3 of 5 (MR# 3, 9,16) discharge records reviewed; and failed to ensure a detailed transfer summary was sent to the receiving health care facility within 2 business of becoming aware of the transfer for 4 of 4 (MR# 2, 9,15,16) records reviewed with transfers to other health care facilities, resulting in a lack of information to ensure continuity of care for these patients. Findings include: MR #2: The patient's start of care (SOC) was 1/28/22 with diagnoses that included Hypertensive Heart & Chronic Kidney disease with Heart Failure, Congestive Heart Failure (CHF) and Pressure Ulcer right buttock. During the clinical record review on 4/19/22 at 10:30 a.m., it was noted that the patient was transferred to the hospital on 2/16/22. The "Transfer Summary" dated 2/16/22 was vague in nature and gave no details of the reason for transfer to the hospital, summary of care or health status at the time of transfer. The summary stated, "Admitted to Crittenton Hospital for cardiac arrest, Reason for Transfer: Hospitalized, Summary of Care: Patient instructed in strengthening exercises, therapeutic activities..., Care Coordination: Physician notified of discharge summary availability." The Transfer Summary failed to detail the course of care, health status at the time of transfer, reason for transfer and evidence that the Transfer Summary had been sent to the Physician. These findings were reviewed with and acknowledged by the Chief Operations Officer (COO #1) during an interview on 4/20/22 at 3:40 p.m. MR #3: The patient's SOC was 9/30/21. The period of care reviewed was 1/28/22 through 3/26/22 with diagnoses that included Displaced Fracture second cervical vertebrae. The patient was ordered to receive Physical Therapy (PT) services at a frequency of 1x/wk. x 1wk., 2x/wk. x 2wks., 1x/wk. x 6wks. During the record review on 4/19/22 at 1:30 p.m., it was noted that the patient was discharged from PT services on 3/26/22. The Discharge Summary dated 3/26/22 documented, "Physician notified of discharge summary availability." There was no documented evidence that the discharge summary was sent to the Physician within 5 days of the date of discharge as per this requirement. These findings were reviewed with and acknowledged by COO #1 during an interview on 4/21/22 at 9:40 a.m. MR#16: This 70-year-old patient was admitted to home care on 1/23/22 with a primary diagnosis of diabetes with pressure ulcers on the right heel. During record review on 4/18/22, it was noted that the patient was discharged from the agency on 3/1/22. The 3/1/22 discharge summary indicates the reason for discharge was because the patient was hospitalized and notes that the "Patient was admitted to the hospital for unknown reasons." The discharge summary indicates the physician was notified of the availability of the discharge summary. There was no evidence that the discharge summary was sent to the physician within 5 business days of discharge. On 3/8/22, the physical therapist (PT #2) documents a transfer summary that notes the patient was transferred to the hospital with hospital admission on 3/8/22 due to wound infection or deterioration. There was no indication of which hospital the patient was sent and no evidence that a transfer summary had been sent to the receiving hospital within 2 business days of becoming aware of the transfer. The findings were reviewed with and confirmed by the clinical manager (COO#1) during an interview on 4/20/22 at 2:00 p.m. COO#1 reviewed the medical record and could provide no evidence that the discharge summary had been sent to the physician and the transfer summary had been sent to the receiving hospital. MR#15: This patient was admitted to the Agency on 2/13/22 with diagnoses of Parkinson's disease, chronic kidney disease, and peripheral neuropathy. During the clinical record review on 4/20/22, it was revealed the patient was transferred to the hospital due to a fall. Subsequent review of the transfer summary noted that on 3/2/22, the occupational therapist (OT#3) documented the following under section "Summary of Care": "Patient case opened for start of care- SN, OT, and PT. However, shortly after starting services patient experienced a fall in ALF resulting in being admitted to the hospital.” No documentation was found within the transfer summary detailing the summary of care provided among ordered disciplines or the health status at the time of transfer. In addition, OT#3 documented the physician had been notified of the discharge summary availability upon request, but there was no indication the physician had been sent a copy. The Transfer Summary failed to detail the course of care, health status at the time of transfer, and evidence that the Transfer Summary had been sent to the Physician. These findings were reviewed and acknowledged by the Chief Operations Officer (COO#1) during an interview on 4/21/22 at 2:05 PM. MR#9: The Start of Care for this patient was dated 2/10/2022. The Plan of Care for the certification period 2/10/2022 to 4/10/2022 included a primary diagnosis of Hypertensive Heart Disease with Heart Failure (CHF) and secondary diagnoses of Acute on Chronic combined systolic and diastolic heart failure, ventricular tachycardia, and chronic atrial fibrillation. During record review on 4/21/2022, a transfer summary dated 3/15/2022 was noted in the patient's record and signed by the physical therapist (PT#3). The PT documented, "patient was transferred to the hospital with hospital admission, however the Transfer Summary failed to detail the reason for the transfer, or the name of the hospital receiving the patient. PT#3 documented the reason for transfer as "hospitalized". There was no evidence that a transfer summary had been sent to the receiving hospital within 2 business days of becoming aware of the transfer. In addition, PT#3 documented the physician had been notified of the discharge summary availability, but there was no indication the physician had been sent a copy These findings were reviewed and confirmed by the clinical manager (COO#1) during an interview on 4/21/22 at 2:00 p.m. COO#1 reviewed the medical record and could provide no evidence that the discharge summary had been sent to the physician and the transfer summary had been sent to the receiving hospital.