Every finding on record at Supportive Home Health Care, LLC

On October 3, 2023, through October 5, 2023, an Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs. During the survey, Supportive Home Health Care was found to be not in compliance with the requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness. The following condition level deficiency was identified: 42 CFR §484.102 Emergency Preparedness

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to develop an emergency preparedness plan (see E0004); failed to develop an emergency preparedness communication plan (see E0029); and failed to develop and maintain an emergency preparedness training and testing program (see E0036). These deficient practices have the potential to negatively affect the health and safety of the agency's 8 current patients. Findings include: The cumulative effect of these systemic problems results in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR 484.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop an emergency preparedness plan, resulting in the potential to negatively affect the health and safety of the agency's 8 current patients in the event of an actual agency or community-based emergency. Findings include: The agency's Emergency Preparedness (EP) documentation was reviewed on 10/5/23. During review it was noted that the agency has EP policies but failed to develop an EP plan based on both agency-based and community-based risk assessments. The hazard vulnerability assessment (HVA) was not dated and there was no indication as to when the form had been completed. The HVA had check marks next to various hazard events but failed to total the scores or prioritize the possible hazard events. The HVA also failed to indicate whether the form was completed with regards to hazards that could occur at the agency or within the communities the agency provides care. During an interview on 10/5/23 at 11:49 a.m., Staff A (administrator) was queried regarding the agency's EP plan. Staff A submitted for review a 77-page document titled, "Emergency Preparedness Packet for Home Health Agencies" (copyright 2008), which is an EP training document prepared by The National Association for Home Care & Hospice. The Supportive Home Health Care logo had been placed throughout the training document. All documents/forms provided within the training document were blank of information pertinent to Supportive Home Health Care. There was no evidence that the agency had developed an Emergency Preparedness plan. The findings were reviewed with and acknowledged by Staff A during a subsequent interview on 10/5/23 at 2:00 p.m.

Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop an emergency preparedness communication plan, resulting in the inability to coordinate patient care for the agency's 8 current patients in the event of an agency-based emergency or community disaster. Findings include: The agency's Emergency Preparedness (EP) documentation was reviewed on 10/5/23. During review it was noted that the agency has EP policies but failed to develop an EP communication plan that includes all elements as required in this regulation. Staff A (administrator) acknowledged the findings during an interview on 10/5/23 at 2:00 p.m.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness training and testing program, resulting in the potential to negatively affect the health and safety of the agency's 8 current patients. Findings include: The agency's Emergency Preparedness (EP) documentation was reviewed on 10/5/23. During review it was noted that there was no documented evidence of staff training or testing. During an interview on 10/5/23 at 11:49 a.m., Staff A (administrator) was queried regarding EP training and testing. Staff A replied that he has owned the company for just under 2 years. All staff are contracted through another company owned by Staff A and there has been no training of staff and no testing of the EP plan.

A Medicare recertification survey was conducted on 10/3/23 through 10/6/23 by the Michigan Department of Licensing and Regulatory Affairs at: Supportive Home Health Care, LLC. 32003 Plymouth Rd., Suite 1 Livonia, MI 48150 At the time of the survey, the agency did not operate any branch offices or subunits. Clinical records reviewed for this survey included 4 active records without a home visit; 1 active record with a home visit (due to low current census and only 1 discipline/clinician actively seeing patients at the time of the survey); and 2 discharge records for a total of 7 records. The following Condition level deficiencies were identified at: 42 CFR §484.60 Care planning, coordination of services, and quality of care. 42 CFR §484.65 Quality Assessment/Performance Improvement 42 CFR §484.70 Infection prevention and control. 42 CFR §484.80 Home health aide services 42 CFR §484.102 Emergency Preparedness 42 CFR §484.105 Organization and administration of services As a result of the Condition level noncompliance, 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).

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients were informed of the Administrator's name to receive complaints, resulting in the potential for patient complaints or concerns to go unaddressed which could negatively affect the quality of care for the agency's 8 current patients. Findings include: During review of the agency's start of care booklet on 10/3/23, it was noted that page 9 and the back page of the booklet both indicate the name of a former administrator and not the name of the current administrator (Staff A). During an interview on 10/5/23 at 2:00 p.m., Staff A explained that the former administrator left the agency on 5/8/23 and acknowledged that the booklet had not been updated to reflect the name of Staff A.

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 record review and interview, the agency failed to ensure the patient was able to participate in, be informed about, and consent or refuse care in advance of and during treatment in 3 of 7 (Patient #’s 1, 2, and 3) records reviewed potentially resulting in those patients being uninformed of the planned services and care that would be provided by the agency. Findings include: P-1: This 64-year-old patient was admitted to the agency on 8/30/23 with diagnoses which included spinal stenosis of the lumbar region (space inside back bone is too narrow and puts pressure on spinal cord); fractures of the ribs; and high blood pressure. The medical record was reviewed on 10/4/23. There were no forms signed by the patient giving consent for the agency to provide treatment to the patient found in the medical record during review. P-2: This 72-year-old patient was admitted to the agency on 8/15/23 with diagnoses which included gallstones with obstruction; Cirrhosis (scarring in the liver); and type 2 Diabetes. The medical record was reviewed on 10/5/23. There were no forms signed by the patient giving consent for the agency to provide treatment to the patient found in the medical record during review. P-3: This 93-year-old patient was admitted to the agency on 8/24/23 with diagnoses which included heart failure; chronic obstructive pulmonary disease (inflammation in lungs causing difficulty in breathing); pulmonary hypertension (high blood pressure in the arteries of the lungs); and type 2 Diabetes. The medical record was reviewed on 10/5/23.There were no forms signed by the patient giving consent for the agency to provide treatment to the patient found in the medical record during review. The Administrator (Staff A) and Clinical Manager (Staff B) were queried on 10/6/23 at 11 a.m. regarding whether the agency had obtained signed consent for treatment from P-1, P-2, or P-3. Staff A searched each of the medical records and was not able to find any signed consent forms for the above patients. Staff B stated that the signed consents were probably in the homes of each patient, but as part of the medical record, should have been uploaded into each patient’s medical record.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the initial assessment visit was conducted within 48 hours of referral for 1 of 7 (Patient #4) records reviewed, and failed to ensure a registered nurse conducted an initial assessment visit to determine immediate care needs within 48 hours of returning home in 1 of 7 (Patient #2), resulting in a delay in determining the immediate care and support needs for these patients. Findings include: P-2: This 72-year-old patient was admitted to the agency on 8/15/23 with diagnoses which included gallstones with obstruction; Cirrhosis (scarring in the liver); and type 2 Diabetes. The medical record was reviewed on 10/5/23. The physicians order for referral was dated 7/26/23 and requested home health services to include physical therapy (PT); registered nursing (RN); occupational therapy and home health aide. The patient was discharged home from an inpatient unit of 8/14/23. The start of care (SOC) comprehensive assessment was completed by the PT on 8/15/23. The first RN visit did not occur until 7 days after the SOC (on 8/22/23). This finding was reviewed and acknowledged with the Administrator (Staff A) and the Clinical Manager (Staff B) during interview on 10/6/23 at 11 a.m. Staff B stated that the RN was not available to make the SOC visit. **Policy in the Administrative Policy Manual titled "Timelines" (last revised on 8/1/20) stated on page 388, "The evaluation visit for admission to Agency is conducted within 48 hours of referral, or within 48 hours of the patient's/client's return home, or on the physician and/or non-physician practitioner start of care date. In instances where the patient/client requests a delay in start of care date, the Agency will contact the physician and/or non-physician practitioner to request a change in the start of care date and such change will be documented in the medical record." P-4: This 89-year-old patient was admitted to home care on 6/12/23 with the diagnosis of right hip strain and right hip contusion (bruise). During record review on 10/4/23, it was determined the referral to start home care was faxed to the agency on 6/7/23, however, the patient did not receive a visit for the initial assessment until 6/12/23. The Administrator (Staff A) and Clinical Manager (Staff B) were queried regarding the reason for the delay during an interview on 10/6/23 at 9:50 a.m. Staff A and Staff B were unable to provide documentation to justify the delayed start in care and acknowledged the findings.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was completed within 5 calendar days for 1 of 7 (P-6) records reviewed, resulting in a lack of information to direct and support the care needs for this patient. Findings include: P-6: This 84-year-old patient was admitted to home care on 8/31/23 with diagnoses of non-cancerous enlarged prostate gland with lower urinary tract. The physical therapist began the comprehensive assessment on 8/31/23. During record review on 10/4/23 it was noted that the comprehensive assessment was incomplete. Pages 22 thru 33 of the comprehensive assessment were blank of information. There was no documentation to indicate why the assessment was not completed and no indication the patient had declined care. The findings were reviewed with Staff A (administrator) and Staff B (clinical manager) during an interview on 10/5/23 at 2:00 p.m. Staff A explained that the patient had decided to receive care from another agency. Note, the active patient census provided by the agency indicates this patient is active and currently receiving home care services. There was no documented evidence to confirm the explanation provided by Staff A.

Eligibility for Medicare home health benefit CFR(s): 484.55(b)(2) Except as provided in paragraph (b)(3) of this section, a registered nurse must complete the comprehensive assessment and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment to determine eligibility for the Medicare home health benefit was completed by the registered nurse in 1 (Patient #4) of 7 records reviewed, resulting in the potential for a patient who is ineligible for benefits to be admitted to home care and as well as the potential for unmet care needs. Findings include: **Policy in the Administrative Policy Manual titled "Initial Patient/Client Comprehensive Assessment" (last revised 3/9/23) stated on page 223, "If nursing care is ordered, an RN must complete the initial assessment, and for Medicare patients/clients, determine eligibility for the Medicare home health benefit, including homebound status. When rehabilitation therapy service (speech-language pathology, physical therapy, or occupational therapy) is the only service ordered by the physician and/or non-physician practitioner who is responsible for the home health plan of care if the need for that service establishes program eligibility, the initial assessment may be made by the appropriate rehabilitation skilled professional." P-4: This 89-year-old patient was admitted to home care on 6/12/23 with the diagnosis of right hip strain and right hip contusion (bruise). The referral dated 6/7/23 requested services from skilled nursing, physical therapy and occupational therapy. During record review on 10/4/23, it was determined the initial assessment for the start of care was completed by the physical therapist on 6/12/23 at 2:00 p.m. and skilled nursing started later that day at 5:45 p.m. The Administrator (Staff A) and Clinical Manager (Staff B) were queried regarding the reason for the physical therapist completing the comprehensive assessment instead of the registered nurse during an interview on 10/6/23 at 9:50 a.m. Staff B reported the nurse may not have been available until later, however acknowledged that doesn't follow their own policy. Staff A also acknowledged the findings at that time.

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 record review and interview, the agency failed to ensure the comprehensive assessment included a review of all medications taken by the patient for potential adverse effects, drug reactions, and duplicative drug therapy in 7 of 7 (Patient #’s 1, 2, 3, 4, 5, 6, 7) records reviewed, resulting in the potential for undetected or harmful medication interactions and poor patient outcomes. Findings include: P-1: This 64-year-old patient was admitted to the agency on 8/30/23 with diagnoses which included spinal stenosis of the lumbar region (space inside back bone is too narrow and puts pressure on spinal cord); fractures of the ribs; and high blood pressure. The medical record was reviewed on 10/4/23. During review of the medication profile, the agency’s electronic medical record software provided a “Medication Interaction” review which revealed the patient’s medication list had 1 “Duplicative Therapy”; 1 “Review Suggested”; and 2 “Potential Interaction Risk” found. The Patient Medication Record had been signed by a contracted registered nurse (RN), who had marked that the physician had not been contacted regarding medication discrepancies or interactions because there was none noted during the medication review. This finding was reviewed and acknowledged with the Administrator (Staff A) and Clinical Manager (Staff B) on 10/6/23 at 11 a.m. P-2: This 72-year-old patient was admitted to the agency on 8/15/23 with diagnoses which included gallstones with obstruction; Cirrhosis (scarring in the liver); and type 2 Diabetes. The medical record was reviewed on 10/5/23. During review, it was noted that there were no medications listed in the comprehensive assessment, no medications listed in the medication profile, and no “Patient Medication Record” found in the medical record. The comprehensive assessment did not document that the patient was not taking medications. During review of the RN visits, it was noted on the visit dated 8/22/23, the RN gave instruction on the difference between Levemir and Humalog (both diabetes medications). On the RN visit note from 8/29/23, the RN gave instruction on Metformin and Januvia (both diabetes medications) including any possible side effects to monitor for. In the same visit, the RN also gave instruction on Furosemide (diuretic medication). On the RN visit note dated 9/7/23, the RN gave instruction on the medication Omeprazole (used to reduce acid in the stomach). These findings were reviewed and acknowledged with Staff A and Staff B during interview on 10/6/23 at 11 a.m., and when queried regarding if this patient with the stated diagnoses and multiple medication instruction sessions from the RN was taking medications, neither Staff A nor Staff B were able to determine so from the medical record. Neither Staff A nor Staff B were able to explain why this medical record did not either list the medications taken by the patient or show documentation that the patient did not take medications. P-3: This 93-year-old patient was admitted to the agency on 8/24/23 with diagnoses which included heart failure; chronic obstructive pulmonary disease (inflammation in lungs causing difficulty in breathing); pulmonary hypertension (high blood pressure in the arteries of the lungs); and type 2 Diabetes. The medical record was reviewed on 10/5/23. During review of the medication profile, the agency’s electronic medical record software provided a “Medication Interaction” review which revealed the patient’s medication list had 2 “Duplicative Therapy” found; 3 “Review Suggested” interactions; and 6 “Potential Interaction Risk” found. The Patient Medication Record had been signed by a contracted RN who had marked that the physician had not been contacted regarding medication discrepancies or interactions because there was none noted during the medication review. This finding was reviewed and acknowledged with Staff A and Staff B on 10/6/23 at 11 a.m. P-6: This 84-year-old patient was admitted to home care on 8/31/23 with diagnoses of non-cancerous enlarged prostate gland with lower urinary tract. The physical therapist began the comprehensive assessment on 8/31/23. During record review on 10/4/23 it was noted that the comprehensive assessment failed to include a review of the patient's medications. The findings were reviewed with Staff A (administrator) and Staff B (clinical manager) during an interview on 10/5/23 at 2:00 p.m. Staff A explained that the patient had decided to receive care from another agency. Note, the active patient census provided by the agency indicates this patient is active and currently receiving home care services. There was no documented evidence to confirm the explanation provided by Staff A. P-7: This patient was admitted to home care on 9/29/22 with diagnoses of hypertensive heart disease with heart failure. During record review on 10/4/23, it was noted that a skilled nursing visit note dated 10/6/22 documents the patient is taking Colace daily in the evening and that it's helping with constipation. Colace is not listed on the plan of care, the 9/29/22 med profile or the 11/21/22 med profile. There is no indication that Colace was included in the review of all the patient's medications. A medication interaction report was generated on 10/4/23 utilizing the agency's medical records software. The interaction report indicates the patient is taking several duplicate therapy medications: Carvedilol, Entresto, Hydralazine HCl + Spironolactone (vasodilators) along with several duplicate inhaler medications: Proventil, Albuterol, Wixela, Tiotropium Bromide Monohydrate, and Incruse Ellipta. The patient medication report signed by the registered nurse on 9/29/22 indicates the physician was not notified of any medication discrepancies or interactions. The findings were reviewed with Staff A and Staff B during an interview on 10/5/23 at 2:00 p.m. Staff B states the physician is to be informed of all interactions and duplicate drug therapies. **Policy in the Administrative Policy Manual titled "Medication List and Monitoring" (last revised 2/20/23) stated on page 285, "An agency registered nurse (RN) will be responsible for coordinating the efforts of monitoring the medication regimen by compiling assessment data through a collaborative effort of all agency staff involved in the patient's/client's care," and on page 286, " An adverse patient/client response, lack of patient/client response, and/or concerns about compliance, potential interactions, duplication or contraindications will be communicated to the physician, as well as documented in the medical record." P-4: This 89-year-old patient was admitted to home care on 6/12/23 with the diagnosis of right hip strain and right hip contusion (bruise). During record review on 10/4/23, it was determined a medication profile was completed by a contracted registered nurse (not a nurse employed by the agency per policy) on 6/12/23. The registered nurse signed it stating there were no discrepancies in the profile. Upon further review of the medications using the medication reconciliation located in the electronic medical record system, it was determined there were 2 duplicate therapies listed as well as 8 medication interactions with "review suggested" and 2 with "potential interaction risk" noted. P-5: This 85-year-old patient was admitted to home care on 10/25/22 with the diagnosis of hypertensive heart disease with heart failure. During record review on 10/4/23, it was determined a medication profile was completed by a contracted registered nurse (not a nurse employed by the agency per policy) on 10/6/22, more than 2 weeks prior to the actual start of care. The registered nurse signed it stating there were no discrepancies in the profile. Upon further review of the medications using the medication reconciliation located in the electronic medical record system, it was determined there were 2 duplicate therapies listed 6 medication interactions with "review suggested" and 5 with "potential interaction risk" noted. There was no updated medication review done at the start of care. Findings were reviewed with the Administrator (Staff A) and Clinical Manager (Staff B) during an interview on 10/6/23 at 9:50 a.m. Staff A and Staff B acknowledged that they are not following their own policy regarding medication review.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was updated and revised in 1 (Patient #4) of 7 records reviewed at discharge from care, resulting in the lack of updated information to determine the continuing care needs of the patient and no record of the patient's progress towards the goals established in the plan of care. Findings include: P-4: This 89-year-old patient was admitted to home health on 6/12/23 with the diagnosis of right hip strain and right hip contusion (bruise). During record review on 10/4/23, it was determined the patient was receiving services from skilled nursing and physical therapy. Upon further review of the record, it was noted skilled nursing discharged services on 7/18/23. There was a daily note located in the record for this date, however there was no discharge note to update the patient's current status and progress towards established goals. The Administrator (Staff A) and Clinical Manager (Staff B) acknowledged the findings during an interview on 10/6/23 at 9:50 a.m.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure that each patient receiving home health services had an individualized written plan of care that was established, periodically reviewed, and signed by a doctor in 2 of 7 (Patient #’s 2, and 6) records reviewed (see G572); failed to ensure the plan of care included appropriate patient-specific interventions in 2 of 7 (Patient #'s 1 and 5) records reviewed (see G574); failed to ensure all patient care orders were recorded in the plan of care for 1 of 7 (Patient # 2) records reviewed (see G576); failed to ensure conformance to the physician orders in the plan of care for 1 of 7 (Patient #5) records reviewed (see G578); and failed to ensure all services, and treatments were administered only as ordered by a physician in 1 of 7 (Patient #2) records reviewed (see G580). These deficient practices have the potential to negatively affect the health and safety of the agency's 8 current patients. The cumulative effect of these systemic problems result in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR §484.60 Care planning, coordination of services, and 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 that each patient receiving home health services had an individualized written plan of care that was established, periodically reviewed, and signed by a doctor in 2 of 7 (Patient #'s 2, and 6) records reviewed resulting in the inability of the agency to identify and facilitate which services were needed to provide health improvement for the patient. Findings include: P-6: This 84-year-old patient was admitted to home care on 8/31/23 with diagnoses of non-cancerous enlarged prostate gland with lower urinary tract. During record review on 10/4/23 it was noted that there was no individualized plan of care written for this patient. The finding was reviewed with Staff A and Staff B during an interview on 10/5/23 at 2:00 p.m. Staff A explained that the patient had decided to receive care from another agency. Note, the active patient census provided by the agency indicates this patient is active and currently receiving home care services. There was no documented evidence to confirm the explanation provided by Staff A. There was no documentation to indicate the physician was informed that a plan of care was not developed for this patient. P-2: This 72-year-old patient was admitted to the agency on 8/15/23 with diagnoses which included gallstones with obstruction; Cirrhosis (scarring in the liver); and type 2 Diabetes. The medical record was reviewed on 10/5/23. During review, no individualized plan of care (POC) was found in the medical record. This finding was reviewed with the Administrator (Staff A) and Clinical Manager (Staff B) on 10/6/23 at 11 a.m. and both acknowledged that a POC had not been written, established, or signed by the physician for this patient.

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 included appropriate patient-specific interventions in 2 (Patient #'s 1 and 5) of 7 records reviewed, resulting in the potential for the patient to not receive care specific to their needs and the inability to determine the patient's progress towards achieving goals. Findings include: P-1: This 64-year-old patient was admitted to the agency on 8/30/23 with diagnoses which included spinal stenosis of the lumbar region (space inside back bone is too narrow and puts pressure on spinal cord); fractures of the ribs; and high blood pressure. The medical record was reviewed on 10/4/23. During review of the comprehensive assessment dated 8/30/23, it was noted that the patient suffered from pain which had an intermittent intensity of 4/10 (where 0 is no pain and 10 is the worst pain ever felt) and the patient’s goal for pain was noted to be 1-2/10. The patient was also noted to suffer chronic constipation made worse by the pain medication (oxycodone, a strong narcotic). When reviewing the plan of care, it was noted the agency failed to include a patient-specific measurable outcome or goal related to chronic constipation, and failed to include a measurable goal for pain that would enable to agency staff to determine progress toward the patient’s goals of care. These findings were reviewed and acknowledged with the Administrator (Staff A) and Clinical Manager (Staff B) on 10/6/23 at 11 a.m. P-5: This 85-year-old patient was admitted to home care on 10/25/22 with the diagnosis of hypertensive heart disease with heart failure. During chart review on 10/4/23, it was noted the plan of care dated 10/25/22 included an intervention order for "SN (skilled nursing) to instruct patient when (s)he starts feeling chest pain, tightness, or squeezing in the chest to take nitroglycerin. Patient may take nitroglycerin one time every 5 minutes. If no relief after 3 doses, call 911." Under the goals and outcomes section, it was documented that "Patient will remain free from chest pain, or chest pain will be relieved with nitroglycerin, during the episode." Upon review of the patient's medication list, it was determined the patient was not prescribed nitroglycerin. Findings were reviewed with and acknowledged by the Administrator (Staff A) and Clinical Manager (Staff B) during an interview on 10/6/23 at 9:50 a.m. who confirmed there were no orders for nitroglycerin to be taken by the patient.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patient care orders were recorded in the plan of care for 1 of 7 (Patient # 2) records reviewed resulting in a lack of physician oversight and input regarding the patient's plan of care and the potential for services not provided as ordered. Findings included: P-2: This 72-year-old patient was admitted to the agency on 8/15/23 with diagnoses which included gallstones with obstruction; Cirrhosis (scarring in the liver); and type 2 Diabetes. The medical record was reviewed on 10/5/23. During review it was noted that the physician referral for home care dated 7/26/23 included orders for registered nurse (RN); physical therapy (PT); occupational therapy (OT) and home health aide (HHa). There were no additional physician orders entered for this patient including a plan of care. The RN made 4 documented visits between the dates of 8/22/23 to 9/12/23 and included an RN note stating “discharge today” on 9/12/23. PT made 15 documented visits between the dates of 8/15/23 to 10/2/23 and had upcoming visits scheduled for 10/5, 10/9, and 10/12/23. There were no notes regarding evaluation for, or scheduling of, OT or HHa services. This finding was reviewed and acknowledged with the Administrator (Staff A) and Clinical Manager (Staff B) on 10/6/23 at 11 a.m. who gave no explanation to how the agency made determination as to the frequency for RN and PT visits or why OT and HHa had not evaluated the patient for services as ordered in the referral.

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 conformance to the physician orders in the plan of care for 2 (Patient #5, 7) of 7 records reviewed, resulting in the potential for poor patient outcomes and unmet care needs. Findings include: P-5: This 85-year-old patient was admitted to home care on 10/25/22 with the diagnosis of hypertensive heart disease with heart failure. During record review on 10/4/23, it was determined the plan of care indicated skilled nursing services 1 time a week for 3 weeks, physical therapy for 1 time a week for 1 week and 2 times a week for 4 weeks, occupational therapy for 1 time a week for 1 week and 2 times a week for 2 weeks and home health aide for 1 time a week for 1 week and 2 times a week for 3 weeks. This was signed by the physician on 11/16/22. During further record review, it was noted that no visits were made by a home health aide. The Administrator (Staff A) and Clinical Manager (Staff B) were queried regarding the reason for no home health aide visits during an interview on 10/6/23 at 9:50 a.m. Staff A and Staff B reported the patient may not have needed services due to having other help at home but acknowledged there was no documentation to support that. There was also no documentation or communication with the physician to discontinue the order. Upon further review of the record, it was determined that an order was written to "Notify physician of: Weight greater than (>) 199 lbs...". It was determined the nurse did not record the patient's weight on 1 (dated 11/10/22) of 2 daily treatment visit notes, therefore did not follow the physician's orders. Staff A and Staff B acknowledged the findings during an interview on 10/6/23 at 9:50 a.m. P-7: This patient was admitted to home care on 9/29/22 with diagnoses of hypertensive heart disease with heart failure. During record review on 10/4/23, it was noted that the 9/29/22 plan of care ordered skilled nursing, physical therapy, occupational therapy, and social work services for this patient. The registered nurse created and signed an aide care plan on 10/6/22. The aide provided visits on 10/13/22, 10/15/22, and 10/18/22. There was no physician order to provide aide services to this patient. The findings were reviewed with and acknowledged by Staff A and Staff B during an interview on 10/5/23 at 2:00 p.m.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all services, and treatments were administered only as ordered by a physician in 2 of 7 (Patient #2, 7) records reviewed resulting in potential to provide ineffective or harmful care for this patient. Findings include: P-7: This patient was admitted to home care on 9/29/22 with diagnoses of hypertensive heart disease with heart failure. During record review on 10/4/23, it was noted that the plan of care ordered the nurse to provide 2 visits the first week and then 1 visit each week for 4 weeks. The nurse provided 2 visits in week one and then also documented 2 visits in week three (9/13/22 and 9/15/22). There was no indication why a second visit was provided in week 3 and no physician order to provide the extra visit. The skilled nurse failed to provide visits only as ordered by the physician. The findings were reviewed with and acknowledged by Staff A and Staff B during an interview on 10/5/23 at 2:00 p.m. P-2: This 72-year-old patient was admitted to the agency on 8/15/23 with diagnoses which included gallstones with obstruction; Cirrhosis (scarring in the liver); and type 2 Diabetes. The medical record was reviewed on 10/5/23. There was no plan of care found in the medical record. There were no other physician orders except the physician referral for home care services found in the medical record. The registered nurse (RN) made 4 documented visits between the dates of 8/22/23 to 9/12/23. Each visit included evaluation of blood sugar readings. There were no physician orders to obtain blood sugar readings and no physician ordered parameters to evaluate the blood sugar readings that were taken. The RN also documented an open wound where a biliary drainage tube had been removed prior to admission and noted in the RN visit dated 8/22/23 that the wound was 0.2cm with pink tissue and scant drainage, and a dressing was removed with a new one applied. This wound was also referred to on the RN visit dated 8/29/23 as being present and covered with an island dressing. There were no physician orders for how to clean, monitor or dress the wound. These findings were reviewed and acknowledged with the Administrator (Staff A) and Clinical Manager (Staff B) on 10/6/23 at 11 a.m. Neither Staff A or Staff B could give explanation as to how the RN made determination for the patient’s blood sugar evaluation or wound management.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients were provided written information with the correct name of the agency's clinical manager, resulting in a lack of information to enable the 8 current patients to contact the clinical manager. Findings include: During review of the agency's start of care booklet on 10/3/23, it was noted that page 9 and the back page of the booklet both indicate the name of a former clinical manager and not the name of the current clinical manager (Staff B). During an interview on 10/5/23 at 2:00 p.m., Staff A (administrator) explained that the former clinical manager left the agency on 5/8/23 and acknowledged that the booklet had not been updated to reflect the name of Staff B.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to maintain compliance with this condition of participation. The agency failed to develop a Quality Assessment and Performance Improvement program which could show measurable improvement in health outcomes, patient safety, and quality of care by collecting, measuring, analyzing, and tracking quality indicators (See G 642); failed to collect and utilize quality indicator data and other relevant agency data in the design of its quality assessment and performance improvement program (See G 644); failed to conduct performance improvement projects from 2021 through 2023 (See G 658); and the governing body failed to ensure the agency developed, implemented, and maintain an agency-wide, data driven Quality Assessment and Performance Improvement program from 2021 through 2023 (See G660). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.65, Quality Assessment and Performance Improvement.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview, the agency failed to develop a Quality Assessment and Performance Improvement (QAPI) program which could show measurable improvement in health outcomes, patient safety, and quality of care by collecting, measuring, analyzing, and tracking quality indicators resulting in a lack of evidence of the agency's efforts to monitor agency processes and improve patient outcomes for the 44 patients admitted to the agency in the past 12 months. Findings include: On 10/4/23 at 3:40 p.m., request was made to the Clinical Manager (Staff B), for the agency QAPI program and policies for review. Staff B stated that the agency’s electronic medical record software did tracking and trending, and she would look to see what they (the agency) could find for review. On 10/5/23 at 3:55 p.m., Staff B stated that no QAPI program information was available for review and that the agency had not had a QAPI program since being purchased by the Administrator (Staff A) less than 2 years ago. There was no documented evidence that the agency developed a QAPI program. This finding was confirmed with both Staff A and Staff B during interview on 10/6/23 at 11 a.m.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on interview, the agency failed to collect and utilize quality indicator data and other relevant agency data for the design of a Quality Assessment and Performance Improvement (QAPI) program, resulting in the potential for poor quality outcomes for the 44 patients admitted to the agency in the past 12 months. Findings include: On 10/5/23, the QAPI program data was requested for review. On 10/5/23 at 3:55 p.m., the Clinical Manager (Staff B) stated that no QAPI program data was available for review and that the agency had not been actively performing QAPI program tasks since the agency was purchased by the facility Administrator (Staff A) less than 2 years ago. There was no documented evidence of the agency's efforts in 2021, 2022, or 2023 to collect and utilize quality indicator data to track and trend the quality of care. This finding was confirmed with both Staff A and Staff B during interview on 10/6/23 at 11 a.m.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview, the agency failed to conduct performance improvement projects from 2021 through 2023, resulting in no coordinated efforts to improve patient outcomes for the 44 patients admitted to the agency in the past 12 months. Findings include: On 10/5/23 at 3:55 p.m., the Clinical Manager (Staff B) stated that no data for the agency Quality Assessment and Performance Improvement (QAPI) program was available for surveyor review and that the agency had not had a QAPI program since the Administrator (Staff A) had purchased the agency less than 2 years ago. No documented QAPI performance improvement project data was received for review during the survey. This finding was confirmed with both Staff A and Staff B during interview on 10/6/23 at 11 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 record review and interview, the governing body failed to ensure the agency developed, implemented, and maintained an agency-wide, data driven Quality Assessment and Performance Improvement (QAPI) program from 2021 through 2023 resulting in a lack of oversight by the governing body to ensure patient safety and quality of care improvements for the 44 patients admitted to the agency in the past 12 months. Findings include: Agency policy titled “Governing Body" was received for review on 10/6/23. The policy included "Last Reviewed: 011318". On page 7-8., under, “Responsibilities in the Quality Assessment Performance Improvement (QAPI) Program” it stated: “The Agency will strive to improve operational and patient/client health outcomes by implementing a performance improvement plan that incorporates the following essential processes: I. Designing processes, II. Monitoring performance through data collection, III. Analyzing current performance, and IV. Improving and sustaining improved performance over time.” On 10/5/23 at 3:55 p.m., the Clinical Manager (Staff B) stated that no QAPI program information was available for review and that the agency had not been actively managing the QAPI program since being purchased by the Administrator (Staff A) less than 2 years ago. On 10/6/23, the agency’s Governing Body (GB) policy and one meeting minute from 5/26/23 were reviewed. There was no documented evidence provided that the agency implemented the GB policy and ensured the development, implementation, and maintenance of the agency’s QAPI program along with performance improvement efforts. This finding was confirmed with both Staff A and Staff B during interview on 10/6/23 at 11 a.m.

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, the agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the agency's Quality Assessment Performance Improvement program (See G 684); and failed to provide infection control education to staff (See G 686). The cumulative effects of these systemic problems resulted in the agency's inability to ensure the provision of safe health care for the condition of participation of 42 CFR §484.70 Infection Prevention and Control.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview, the agency failed to coordinate an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of their Quality Assessment Performance Improvement program in 2021 through 2023, resulting in the potential development and spread of infections between staff and the 44 patients admitted to the agency in the past 12 months. Findings include: On 10/4/23 at 3:40 p.m., request was made to the Clinical Manager (Staff B), for the agency Quality Assessment and Performance Improvement (QAPI) program and policies including infection control for review. No documented evidence was given over for review during the survey for the agency's efforts from 2021 through 2023 to coordinate an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of their Quality Assessment Performance Improvement program. This finding was confirmed with both the Administrator (Staff A) and Staff B during interview on 10/6/23 at 11 a.m.

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, the agency failed to provide documented evidence that infection control education was provided to any of the 9 health care personnel contracted by the agency for patient care resulting in the potential for the development and spread of infection. Findings include: On 10/4/23 at 3:10 p.m., request was made to the Administrator (Staff A) for personnel records. During review, it was noted that no infection control training could be found for any staff member. On 10/6/23 at 9:10 a.m., Staff A stated that they would not be able to provide documentation of staff training related to infection control. Staff A stated that staff had to complete training through electronic orientation modules but was not able to provide evidence of infection control education. The Clinical Manager (Staff B) stated that there were no agency staff infection control training documents for review. This finding was again confirmed with both Staff A and the Staff B during interview on 10/6/23 at 11 a.m.

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 skilled professionals performed assessments of the patient's health status and needs in 2 of 7 (P-6, 7) records reviewed with multiple disciplines ordered, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes for these patients. Findings include: P-6: The referral dated 8/30/23 notes that the patient was discharged from the hospital and went to an assisted living facility that morning. The prescription signed by the physician on 8/23/23 orders the patient to receive physical therapy, occupational therapy (OT), speech therapy (ST), registered nurse (RN), and aide services. This 84-year-old patient was admitted to home care on 8/31/23 with diagnoses of non-cancerous enlarged prostate gland with lower urinary tract. The physical therapist began the comprehensive assessment on 8/31/23. During record review on 10/4/23 it was noted that the RN, OT, and ST assessments had not been conducted or documented in the past 33 days since the patient was admitted to home care. The findings were reviewed with Staff A (administrator) and Staff B (clinical manager) during an interview on 10/5/23 at 2:00 p.m. Staff A explained that the patient had decided to receive care from another agency. Note, the active patient census provided by the agency indicates this patient is active and currently receiving home care services. There was no documented evidence to confirm the explanation provided by Staff A. P-7: This patient was admitted to home care on 9/29/22 with diagnoses of hypertensive heart disease with heart failure. During record review on 10/4/23, it was noted that the RN documented that the patient had a stage 1 pressure ulcer on the coccyx that measured 3.2 x 4.4 (no scale indicated). The RN provided 6 additional visits from 10/1/22 thru 10/27/22, when the patient was discharged from skilled nursing services on 10/27/22. Throughout those visits the RN failed to document that the pressure ulcer of the coccyx was assessed. It was unable to be determined if the ulcer had healed or deteriorated throughout the episode of nursing care. The findings were reviewed with Staff A and Staff B during an interview on 10/5/23 at 2:00 p.m. Staff B explained that the nurse should be measuring the pressure ulcer weekly or document that the ulcer is healed.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure services of the skilled professionals were provided as indicated by the physician in the plan of care in 4 (Patient # 1, 2, 4, and 7) of 7 records reviewed, resulting in the potential for poor patient outcomes and unmet care needs. Findings include: P-1: This 64-year-old patient was admitted to the agency on 8/30/23 with diagnoses which included spinal stenosis of the lumbar region (space inside back bone is too narrow and puts pressure on spinal cord); fractures of the ribs; and high blood pressure. The medical record was reviewed on 10/4/23. The plan of care (POC) dated 8/30/23 included orders for the registered nurse (RN) to visit 1 time a week for 3 weeks and physical therapy (PT) to evaluate and treat. The RN made 1 visit (the start of care visit on 8/30/23) and did not make further visits. The PT made 3 visits between 8/30/23 (evaluation) and 9/11/23 (discharge). No physician orders were found in the medical record indicating physician approval or awareness of the frequency discrepancies found in the medical record. This finding was reviewed and acknowledged with the Administrator (Staff A) and Clinical Manager (Staff B) on 10/6/23 at 11 a.m. Staff A stated that the agency did not work with the patient’s insurance and that was why the frequency for nursing had changed but was unable to provide any additional physician orders for RN or PT frequency changes. Of note, this patient was on the current patient census list received at the time of entrance for this survey. P-2: This 72-year-old patient was admitted to the agency on 8/15/23 with diagnoses which included gallstones with obstruction; Cirrhosis (scarring in the liver); and type 2 Diabetes. The medical record was reviewed on 10/5/23. No POC was found in the medical record. The RN made 4 visits, once per week between the dates of 8/22/23 and 9/12/23. PT made a total of 15 visits, 2 times per week between the dates of 8/15/23 and 10/2/23. There were no physician orders regarding frequency of these skilled professionals in the medical record. This finding was reviewed and acknowledged with Staff A and Staff B during interview on 10/6/23 at 11 a.m. P-7: This patient was admitted to home care on 9/29/22 with diagnoses of hypertensive heart disease with heart failure. During record review on 10/4/23, it was noted that the plan of care ordered the nurse to provide 2 visits the first week and then 1 visit each week for 4 weeks. The nurse provided 2 visits in week one and then also documented 2 visits in week three (9/13/22 and 9/15/22). There was no indication why a second visit was provided in week 3 and no physician order to provide the extra visit. The skilled nurse failed to provide visits only as ordered by the physician. The findings were reviewed with and acknowledged by Staff A and Staff B during an interview on 10/5/23 at 2:00 p.m. **Policy in the Administrative Policy Manual titled "Plan of Care" (last revised 3/17/23) stated on page 269, "Each patient must receive the home health services that are written in an individualized plan of care that identifies patient/client-specific measurable outcomes and goals, and which is established and periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry or non-physician practitioner acting within the scope of his or her state license, certification, or registration." P-4: This 89-year-old patient was admitted to home care on 6/12/23 with the diagnosis of right hip strain and right hip contusion (bruise). During record review on 10/4/23, it was determined the referral from the physician dated 6/6/23 requested services from skilled nursing, physical therapy and occupational therapy. Skilled nursing was ordered for 2 times a week for 1 week and 1 time a week for 5 weeks. Physical therapy was ordered for 2 times a week for 9 weeks. During further review, it was determined occupational therapy did not evaluate the patient, therefore no frequency or duration was determined. The Administrator (Staff A) and the Clinical Manager (Staff B) were queried regarding the reason for no occupational therapy evaluation during an interview on 10/6/23 at 9:50 a.m. Staff A and Staff B were unable to provide any documentation to explain the reason the patient was not evaluated and acknowledged she should have been according to the physician's referral. Upon further review of the record, it was determined the patient only received 1 physical therapy visit and 1 skilled nursing visit the week of 7/9/23. The electronic medical record showed a visit scheduled for a progress note on 7/10/23 by both skilled nursing and physical therapy but indicated these visits did not take place. There was no documentation for a reason for a missed visit during that week or a change in the patient's frequency. Staff A and Staff B thought the patient may have been the hospital that day, but acknowledged there was no documentation stating that.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse prepared written patient care instructions that included reportable weight parameters, safety parameters, and skin care instructions for 1 of 1 (P-7) records reviewed (see G798); failed to ensure the aide provided care as instructed for 1 of 1 (P-7) records reviewed (see G800); and failed to ensure documentation of an annual on-site visit to observe and assess the aide while performing care for 1 of 1 (Staff C) aides contracted by the agency (see G812). Findings include: The cumulative effect of these systemic problems results in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR 484.80, Home Health Aide Services.

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, the agency failed to ensure the registered nurse prepared written patient care instructions that included reportable weight parameters, safety parameters, and skin care instructions for 1 of 1 (P-7) records reviewed in which aide services were provided, resulting in a lack of direction regarding the needs of this patient. Findings include: P-7: This patient was admitted to the agency on 9/29/22 with diagnoses of hypertensive heart disease with heart failure. The 9/29/22 plan of care ordered skilled nursing (RN), physical therapy, occupational therapy, and social work services for this patient. Home health aide services were added by the RN the week of 10/10/22. The aide care plan signed by the RN on 10/6/22 ordered the aide to provide 2 visits each week for 3 weeks. The aide was instructed to weigh the patient each visit but the care plan failed to include reportable parameters for the aide to report weight gain which could indicate fluid retention for this patient with heart failure. The aide care instructions failed to include safety precautions regarding oxygen use, bleeding, and use of anticoagulants. These safety measures were noted on the 9/29/22 plan of care. The start of care comprehensive assessment completed by the RN on 9/29/22 documents the patient has a 3.2 x 4.4 (no scale noted) reddened area due to pressure on the coccyx. The pressure area is described by the RN as follows: skin is not broken, but redness is present, reddened area is painful and patient/caregiver applies Calmoseptine to area to prevent wound for (sic) developing. The aide care instructions failed to note the patient's pressure area and the application of Calmoseptine. The findings were reviewed with and acknowledged by Staff A (administrator) and Staff B (clinical manager) during an interview on 10/5/23 at 2:00 p.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 record review and interview, the agency failed to ensure the aide provided care as instructed for 1 of 1 (P-7) records reviewed in which aide services were provided, resulting in the potential for poor patient outcomes. Findings include: P-7: This patient was admitted to the agency on 9/29/22 with diagnoses of hypertensive heart disease with heart failure. The aide care plan signed by the registered nurse on 10/6/22, instructed the aide to complete the following tasks each visit: vital signs (blood pressure, pulse, respiration, and temperature), weight, and range of motion. Staff C (aide) documented 3 visits were provided on 10/13/22, 10/15/22, and 10/18/22. On all 3 visits the aide failed to document vital signs, weight, and range of motion. The findings were reviewed with and acknowledged by Staff A (administrator) and Staff B (clinical manager) during an interview on 10/5/23 at 2:00 p.m.

Direct observation every 12 months CFR(s): 484.80(h)(1)(iii) A registered nurse or other appropriate skilled professional must make an annual on-site visit to the location where a patient is receiving care in order to observe and assess each aide while he or she is performing care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure documentation of an annual on-site visit to observe and assess the aide while performing care for 1 of 1 (Staff C) aides contracted by the agency, resulting in a lack of supervision and oversight of the care provided by this aide. Findings include: Staff C: Contracted aide services. Date of hire is 5/9/22. The personnel documents for Staff C were reviewed on 10/5/23. There was no documented evidence of an annual on-site visit by a registered nurse or other appropriate skilled professional to observe and assess the aide while performing patient care. The findings were reviewed with and acknowledged by Staff A (administrator) and Staff B (clinical manager) during an interview on 10/5/23 at 2:00 p.m.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the governing body assumed full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans and its quality assessment and performance improvement program (see G942); failed to ensure the Administrator was appointed by and reported to the governing body (see G946); failed to ensure the clinical manager provided oversight and coordination of patient care services and personnel for 1 of 7 (P-6) records reviewed (see G962); failed to ensure the clinical manager assured the development of plans of care for 1 of 7 (P-6) records reviewed (see G968); failed to ensure 2 of 2 contracts (Contractor-1, Contractor-2) met the requirements of section 1861(w) of the Act (42 U.S.C. 1395x(w)), (see G976); failed to ensure contracts for services indicated the agency maintains overall responsibility for the services provided under arrangement for 2 of 2 (Contractor-1, Contractor-2) contracts reviewed (see G978); failed to ensure that the primary home health agency is responsible for patient care services for 2 of 2 (Contractor-1, Contractor-2) contracts reviewed (see G980); and failed to ensure at least one qualifying service was provided directly by agency employees (see G982). Findings include: The cumulative effect of these systemic problems results in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR 484.105, Organization and Administrative Services.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the governing body assumed full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and it's operational plans and it's quality assessment and performance improvement program, resulting in a potential for poor management and administrative oversight for the agency's 8 active patients. Findings include: Agency Policy titled “Governing Body" was received for surveyor review on 10/5/23. The policy included "Last Reviewed: 011318". On page 1.(which also had another page number listed as page 1637), under “Overall Responsibilities of the Governing Body” is stated: “The Agency's Governing Body has ultimate responsibility and legal authority… for the management of the Agency and for the provision of a framework which supports all of the functions carried out by the Agency, thereby allowing the Agency to fulfill its mission.” On 10/3/23 at 12:05 p.m., the Administrator (Staff A) stated he had purchased the agency less than 2 years ago. On 10/4/23, request was made to the Administrator to provide documentation for the agency’s governing body (GB) policy and meeting minutes. One document titled “Governing Body Meeting”, dated 5/29/23 was provided for meetings. The GB policy was received for review on 10/6/23 and it was noted that there was no date indicating the GB policy had been reviewed since the agency was purchased. The policy also contained a document titled "Governing Body Members" on page 1. (which also had another page number listed as page 1635), and there were no documented members listed. There was no evidence the agency implemented the GB policy to assume full legal authority and responsibility for the agency's overall management of function and operation. During interview with the Clinical Manager (Staff B) at 3:55 p.m. on 10/5/23, Staff B was queried to whether there was any additional GB activity that could be reviewed, and Staff B stated that all GB activity had been provided.

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Administrator was appointed by and reported to the governing body, resulting in no definitive lines of authority, lack of oversight of patient care and operations of the agency, and the potential for poor patient outcomes. Findings include: Agency Policy titled “Governing Body" was received for surveyor review on 10/5/23. The policy included "Last Reviewed: 011318". On page 1., under “The Agency defines the responsibilities of the Governing Body to include:", it stated: “X11. Appointing a qualified Administrator and Alternate Administrator”. On 10/6/23 during interview with the Administrator (Staff A) and the Clinical Manager (Staff B) at 11 a.m., Staff A was queried to whether he had been appointed by the governing body (GB) to be the administrator of the agency. Staff A stated that he was not appointed. Staff A continued that he was the owner and therefore did not realize that he had to be appointed by the GB as administrator.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical manager provided oversight and coordination of patient care services and personnel for 1 of 7 (P-6) records reviewed, resulting in a potential decline in physical functioning, lack of assistance with personal care needs, and the potential for poor patient outcomes. Findings include: P-6: The prescription signed by the physician on 8/23/23 orders the agency to provide physical therapy (PT), occupational therapy (OT), speech therapy (ST), registered nurse (RN), and aide services. This 84-year-old patient was admitted to home care on 8/31/23 with diagnoses of non-cancerous enlarged prostate gland with lower urinary tract. The PT began the comprehensive assessment on 8/31/23. The clinical record was reviewed on 10/4/23 and there was no evidence that OT, ST, RN, or the aide had seen or contacted the patient since care started on 8/31/23. There was no documentation to indicate the patient or caregiver had declined these services. There was no evidence to indicate the Clinical Manager provided oversight and coordinated OT, ST, RN, or aide services for this patient. The findings were reviewed with Staff A (administrator) and Staff B (clinical manager) during an interview on 10/5/23 at 2:00 p.m. Staff A explained that the patient had decided to receive care from another agency. Note, the active patient census provided by the agency indicates this patient is active and currently receiving home care services. There was no documented evidence to confirm the explanation provided by Staff A.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical manager assured the development of plans of care for 1 of 7 (P-6) records reviewed, resulting in a potential decline in physical functioning, lack of assistance with personal care needs, and the potential for poor patient outcomes. Findings include: P-6: The prescription signed by the physician on 8/23/23 orders the patient to receive physical therapy (PT), occupational therapy (OT), speech therapy (ST), registered nurse (RN), and aide services. This 84-year-old patient was admitted to home care on 8/31/23 with diagnoses of non-cancerous enlarged prostate gland with lower urinary tract. The PT began the comprehensive assessment on 8/31/23. The clinical record was reviewed on 10/4/23 and there was no evidence that the PT had developed a plan of care. There was no evidence plans of care had been developed by the RN, OT, and ST. There was no documentation to indicate the patient or caregiver had declined PT, OT, ST, RN, or aide services. There was no evidence to indicate the Clinical Manager (Staff B) provided oversight and ensured the development and implementation of plans of care for PT, OT, ST, RN, or aide services. The findings were reviewed with Staff A (administrator) and Staff B during an interview on 10/5/23 at 2:00 p.m. Staff A explained that the patient had decided to receive care from another agency. Note, the active patient census provided by the agency indicates this patient is active and currently receiving home care services. There was no documented evidence to confirm the explanation provided by Staff A.

Services under arrangement CFR(s): 484.105(e)(1) The HHA must ensure that all services furnished under arrangement provided by other entities or individuals meet the requirements of this part and the requirements of section 1861(w) of the Act (42 U.S.C. 1395x (w)). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure 2 of 2 contracts (Contractor-1, Contractor-2) met the requirements of section 1861(w) of the Act (42 U.S.C. 1395x(w)), resulting in the potential to adversely affect the finances of all patients that receive contracted services. Findings include: Contractor-1: The contract with Contractor-1 (not dated) was reviewed on 10/5/23. Contractor-1 is a home care agency owned by Staff A (administrator of Supportive Home Health Care). Contractor-1 provides all home care services at Supportive Home Health Care. During review of the contract it was noted that the contract failed to include the regulatory language of section 1861(w) of the Act (42 U.S.C 1395x(w)), which states, "...receipt of payment by the...home health agency...with respect to services for which an individual is entitled to have payment made under this title, discharges the liability of such individual or any other person to pay for the services." The regulatory language ensures that both the contract agency and the home health agency would not simultaneously charge patients for covered services and items. Contractor-2: The contract with Contractor-2 (not dated but signed on 2/20/20) was reviewed on 10/5/23. Contractor-2 is a provider of physical therapy services per the contract. The staff list provided by Staff A indicates that Contractor-2 is providing physical therapy and registered nurse services. During review of the contract, it was noted that the contract failed to include the regulatory language of section 1861(w) of the Act (42 U.S.C 1395x(w)). The findings were reviewed with and acknowledged by Staff A and Staff B (clinical manager) during an interview on 10/5/23 at 2:00 p.m.

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure contracts for services indicated the agency maintains overall responsibility for the services provided under arrangement for 2 of 2 (Contractor-1, Contractor-2) contracts reviewed, resulting in a lack of overall responsibility by the agency for the services provided under arrangement. Findings include: Contractor-1: The contract with Contractor-1 (not dated) was reviewed on 10/5/23. Contractor-1 is a home care agency owned by Staff A (administrator of Supportive Home Health Care). Contractor-1 provides all home care services at Supportive Home Health Care: nursing, physical therapy, occupational therapy, non-skilled care staff, and administrative staff. During review of the contract, it was noted that the contract failed to indicate that the home health agency maintains the overall responsibility for the services provided under arrangement and the way in which they are furnished. Contractor-2: The contract with Contractor-2 (dated 1/1/20) was reviewed on 10/5/23. Contractor-2 is a provider of physical therapy services per the contract. The staff list provided by Staff A indicates that Contractor-2 is providing physical therapy and registered nurse services to the home health agency. During review of the contract, it was noted that the written agreement for services (contract) is between Contractor-2 and Heartland Home Health Care, not Supportive Home Health Care. The contract is not signed by a representative of Contractor-2. This contract is not legally enforceable. The contract fails to ensure the agency maintains overall responsibility for the physical therapy and nursing services provided under arrangement. The findings were reviewed with and acknowledged by Staff A and Staff B (clinical manager) during an interview on 10/5/23 at 2:00 p.m.

Primary HHA is responsible for patient care CFR(s): 484.105(e)(3) The primary HHA is responsible for patient care, and must conduct and provide, either directly or under arrangements, all services rendered to patients. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that the primary home health agency is responsible for patient care services for 2 of 2 (Contractor-1, Contractor-2) contracts reviewed, resulting in a lack of overall responsibility by the agency for patient care services. Findings include: During the entrance interview on 10/3/23 at 11:55 a.m., the Administrator (Staff A) was asked what services were provided by the home health agency. Staff A explained the agency provides skilled nursing, physical therapy, occupational therapy, speech therapy, home health aide and registered dietitian services. When asked which services were provided directly by agency staff, Staff A reported there are no employees currently on the pay roll for this agency. All services are provided through contracts with two contracting agencies. Contractor-1 provides all home care services at Supportive Home Health Care: nursing, physical therapy, occupational therapy, non-skilled care staff, and administrative staff. During review of the contract, it was noted that the contract failed to indicate that the home health agency retains overall responsibility for all services provided. A review of the agency's organizational chart indicates Staff A is in charge of all nursing services and Contractor-2. Staff A does not receive an income (W-2) from Supportive Home Health Care. All patient care services and administrative staff are contracted with either Contractor-1 or-2. The home health agency has delegated all administrative and supervisory responsibilities to contractors. Contractor-2 is a provider of physical therapy services per the contract. The staff list provided by Staff A indicates that Contractor-2 is providing physical therapy and registered nurse services to the home health agency. During review of the contract, it was noted that the written agreement for services (contract) is between Contractor-2 and Heartland Home Health Care, not Supportive Home Health Care. The contract is not signed by a representative of Contractor-2. This contract is not legally enforceable. A review of the agency's organizational chart indicates that Contractor-2 is in charge of all physical therapy, occupational therapy, speech therapy, and social work services. The contract indicates that Contractor-2 provides physical therapy services, yet the organizational chart indicates Contractor-2 is supervising all therapy and social work services that are provided by both Contractor-1 and Contractor-2. The agency is delegating its overall supervisory responsibilities to both Contractors.

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure at least one qualifying service was provided directly by agency employees, resulting in the potential for an interruption in continuity of care and unmet care needs. Findings include. During the entrance interview on 10/3/23 at 11:55 a.m., the Administrator (Staff A) was asked what services were provided by the home health agency. Staff A reported the agency provides skilled nursing, physical therapy, occupational therapy, speech therapy, home health aide and registered dietitian services. When asked which services were provided directly agency, Staff A reported there are no employees are currently on the pay roll for this agency. All services are provided through a contract with another company, which is also owned by Staff A. The agency failed to ensure that at least one qualifying service was provided directly by agency employees. Findings were reviewed and acknowledged at time of discovery.

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 clinical record contained a complete comprehensive assessment for 1 of 7 (P-6) records reviewed, resulting in a lack of information for the physician and all agency staff caring for this patient. Findings include: P-6: This 84-year-old patient was admitted to home care on 8/31/23 with diagnoses of non-cancerous enlarged prostate gland with lower urinary tract. The physical therapist began the comprehensive assessment on 8/31/23. During record review on 10/4/23 it was noted that the comprehensive assessment was incomplete. Pages 22 thru 33 of the comprehensive assessment were blank of information. There was no documentation to indicate why the assessment was not completed and no indication the patient had declined care. The findings were reviewed with Staff A (administrator) and Staff B (clinical manager) during an interview on 10/5/23 at 2:00 p.m. Staff A explained that the patient had decided to receive care from another agency. Note, the active patient census provided by the agency indicates this patient is active and currently receiving home care services. There was no documented evidence to confirm the explanation provided by Staff A. There was no documentation of a completed comprehensive assessment for this patient.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained all interventions, medication administration, treatments, services, and responses to those interventions in 2 of 7 (Patient # 1, 7) records reviewed resulting in an incomplete record and the lack of patient's health status for care needs to be met. P-7: This patient was admitted to home care on 9/29/22 with diagnoses of hypertensive heart disease with heart failure. During record review on 10/4/23, it was noted that the registered nurse (RN) documented in the comprehensive assessment on 9/29/22 that the patient had a stage 1 pressure ulcer on the coccyx that measured 3.2 x 4.4 (no scale indicated). The RN also documented these comments: Skin is not broken, but redness is present, reddened area is painful and patient/caregiver applies Calmoseptine to area to prevent wound for (sic) developing. The plan of care failed to include interventions or treatments regarding the use of Calmoseptine or any other cream(s) to reduce skin shear and friction. The findings were reviewed with Staff A and Staff B during an interview on 10/5/23 at 2:00 p.m. P-1: This 64-year-old patient was admitted to the agency on 8/30/23 with diagnoses which included spinal stenosis of the lumbar region (space inside back bone is too narrow and puts pressure on spinal cord); fractures of the ribs; and high blood pressure. The plan of care (POC) was completed by the nurse and had an episode date range of 8/30/23 through 10/28/23. The POC included physician orders for physical therapy (PT) to evaluate and treat. During record review, on 10/4/23 at 12:39 p.m., the electronic medical record was noted to have a PT Evaluation visit in the “Not Started” status with a target date of 8/30/23, and 4 additional PT visits with target dates of 9/6/23; 9/13/23; 9/20/23; 9/27/23 which all were in “Not Started” status. None of the PT notes had been entered at the time of the record review (35 days from the start of care). During interview with the Administrator (Staff A) and Clinical Manager (Staff B) on 10/6/23 at 11:38 a.m., Staff A viewed the medical record to go over the findings and 3 PT visits had been entered. A PT Evaluation was entered and in the “Completed” status with a visit date of 8/30/23. A PT visit was entered and in the "Completed” status with a visit date of 9/6/23. Finally, a PT Discharge visit was entered and in the “Submitted with Signature” status with a visit date of 9/11/23. Staff A stated that he did not know how those visits could be in the "Not Started" status when viewed on 10/4/23, did not think that they could be signed using a back date, and thought there must be an issue with the electronic medical record software. Staff B stated that a clinician was able to go and complete notes using a back date if the visit fell within the time frame of the episode. No other explanation was provided for how the PT visit notes were missing during survey record review and then in the “Completed” status during findings review.

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 send a completed discharge summary to the primary care provider within 5 business days after discharge in 1 of 7 (Patient #1) records reviewed resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: P-1: This 64-year-old patient was admitted to the agency on 8/30/23 with diagnoses which included spinal stenosis of the lumbar region (space inside back bone is too narrow and puts pressure on spinal cord); fractures of the ribs; and high blood pressure. The medical record was reviewed on 10/4/23. No discharge summary was found at the time of review. During interview with the Administrator (Staff A) and Clinical Manager (Staff B) on 10/6/23 at 11:38 a.m., Staff A found that the physical therapist completed a discharge note on 9/11/23 but was not able to show evidence that a completed discharge summary had ever been sent to the physician after discharge. Staff A and Staff B acknowledge this at the time of the finding.