Every finding on record at Ambi's Home Health Care, LLC

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review, policy & procedure review and staff interview, the agency failed to provide emergency preparedness training to all direct and indirect staff at least every 2 years. The agency employs 18 direct & contracted staff. Findings are: A. Review of the agency’s policy and procedure titled Inservice Education/Staff Development, revised 5/20/22, revealed: 1. Records on in-service education programs will be maintained and will be documented. 2.The policy and procedure did not include where the documentation would be maintained. B. Review of Ambi’s Emergency Plan, dated 1/28/2025, revealed: 1. The Administrator/Director of Nursing (DON) will train staff during orientation and annually during in-house training exercises, including their roles during an emergency. 2. There was no documentation to indicate direct and contracted staff received emergency preparedness training after 4/21/22. 3. Ambi’s Emergency Plan did not include where the documentation would be maintained. C. During an interview on 3/11/25 at 12:15 PM, the Administrator confirmed the agency failed to conduct emergency preparedness training with staff for the years of 2023 and 2024.

A recertification and relicensure survey was completed on 3/11/25. The agency census was 49. Three condition level deficiencies were identified during the survey which include: G570- Care planning, coordination of services, and quality of care. G750- Home health aide services. G940- Organization and administration of services.

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, policy and procedure review, and staff interview, the agency failed to complete a comprehensive assessment of the patient’s rehabilitative needs within 5 days after the start of care for 4 of 6 patients who had orders for Occupational Therapy (OT) and/ or Physical Therapy (PT) included on the plan of care (Patient 1, 3, 7, and 8). Total patient sample size was 8. Total patient census was 49. Findings are: A. Review of the agency's policy and procedure titled Comprehensive Client Assessment, updated 5/6/22, revealed the initial PT and OT comprehensive assessment was to be completed within 5 days of the start of care. B. Review of Patient 1’s clinical record revealed: 1. The Home Health Certification and Plan of Care (POC) for the certification period 12/11/24 through 2/8/25, included orders for (OT) and (PT) to evaluate. 2. The start of care (SOC) was 12/11/24. 3. An initial PT evaluation was completed on 12/20/24 (9 days after the SOC). 4. An initial OT evaluation was completed on 12/23/24 (12 days after the SOC). 5. There was no documentation in the clinical record that the patient or physician requested a delay in the PT and OT initial visit beyond the 5 days. C. Review of Patient 3’s clinical record revealed: 1. The Home Health Certification and Plan of Care (POC) for the certification period 1/24/25 through 3/24/25 included orders for Skilled Nurse (SN) one time each week for 9 weeks. No additional services were ordered at the time. 2. A referral order dated 2/26/25 included orders for (PT) home safety, transfer training, gait training, balance activities, assess fall risk, range of motion (ROM)/strengthening, wheelchair (w/c) mobility, and patient and caregiver education. 3. An initial PT evaluation had not been completed as of 3/5/25 (7 days after the order). 4. There was no documentation in the clinical record that the patient or physician requested a delay in the PT initial visit beyond the 5 days. D. Review of Patient 7’s clinical record revealed: 1. The Home Health Certification Plan of Care for the certification period 6/14/24 through 8/12/24, included orders for an OT and PT referral. 2. The SOC was 6/14/24. 3. An initial OT evaluation was completed on 7/2/24 (18 days after the SOC). 4. An initial PT evaluation was completed on 7/2/24 (18 days after the SOC). 5. There was no documentation in the clinical record that the patient or physician requested a delay in the PT and/or OT initial visit beyond the 5 days. E. Review of Patient 8's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period 2/14/25 through 4/14/25, included orders for OT and PT to eval and treat. 2. The SOC date was 2/14/25. 3. An initial OT evaluation was completed on 2/20/25 (6 days after the SOC). 4. An initial PT evaluation was completed on 2/21/25 (7 days after the SOC). 5. There was no documentation in the clinical record that the patient or physician requested a delay in the OT and/or PT initial visit beyond the 5 days. F. During an interview on 3/11/25 at 12:15 PM, the Administrator confirmed the OT and PT comprehensive assessments for Patients 1, 3, 7, and 8 was not completed within 5 days of the patient’s SOC and/or physician order, and the clinical record did not include documentation in the clinical record to request a delay in the OT and PT comprehensive assessments.

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: Deficiencies cited at G572, G576, G580 Findings are: G572 Based on record review, policy and procedure review, and staff interview, the agency failed to ensure the home health services were provided as written in the patient's physician-approved plan of care for 5 of 8 patient records reviewed (Patient 2, 3, 4, 5, and 6). The total patient census was 49. G576 Based on record review, policy and procedure review, and staff interview, the agency failed to ensure all physician orders were accurately recorded in the patient's plan of care for 1 of 1 patient who received wound care (Patient 6). Total patient sample was 8. Total patient census was 49. G580 Based on record review, policy and procedure review, and staff interview, the agency failed to ensure wound care treatments were completed as ordered for 1 of 1 patient (Patient 6) patient who received wound care treatments. Total patient sample was 8. Total patient census was 49.

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, policy and procedure review, and staff interview, the agency failed to ensure the home health services were provided as written in the patient's physician-approved plan of care for 5 of 8 patient records reviewed (Patient 2, 3, 4, 5, and 6). The total patient census was 49. Findings are: A. Review of the agency policy and procedure titled Plan of Care Policy and Procedures, updated 5/9/22, revealed: 1. The plan of care is a dynamic process that addresses the care, treatments and services to be provided. 2. Professional staff are to promptly alert the physician to any changes that suggest a need to alter the plan of care. B. Review of the agency policy and procedure titled Coordination of Client Services, undated, revealed: 1. Whenever there are significant changes made to the plan of care, the patient, the caregiver, and the patient's physician was to be informed. 2. Documentation was to address the coordination of activities, and any training and education provided to the client or caregiver. C. Review of the agency policy and procedure titled Missed Visit Policy, revised 5/20/22, revealed staff was to notify the physician of missed visits, including the reason for the missed visit. The policy also revealed staff were to attempt to reschedule the missed visits. D. Review of Patient 2's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 11/22/24 through 1/20/25 and 1/21/25 through 3/21/25 included orders for Skilled Nurse (SN) one time a week for 9 weeks and Home Health Aide (HHA) services daily. 2. There were no HHA visits documented 12/29/24 through 1/20/25 and 1/23/25 through 1/31/25. 3. Documentation revealed SN visit were completed: a. 12/1/24- 12/7/24, 2 visits. b. 12/8/24-12/14/22, 3 visits. c. 12/22/24-12/28/24, 3 visits. d. 12/29/24-1/4/25, 4 visits. e. 1/5/25-1/11/25, 3 visits. f. 1/12/25-1/18/25, 7 visits. 4. There was no documentation of the reason to justify the need to increase SN or decrease HHA visits. 5. There was no documentation in the clinical record the physician was notified to alter the frequency of SN or HHA visits. E. Review of Patient 3's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 11/25/24 through 1/23/25 and 1/24/25 through 3/24/25 included orders for SN one time each week for 9 weeks. 2. Documentation revealed missed visit notification to the patient's physician on five consecutive Mondays beginning with 1/27/25 and ending on 2/24/25 (last SN visit documented). There was no documentation that the SN attempted to reschedule the missed visits for another day during the week or attempts to resolve the reason the patient was missing the SN visits. F. Review of Patient 4's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 2/11/25 through 4/11/25 included orders for SN 2-4 times each week for 9 weeks and 6 as needed visits. 2. There was one SN visit documented the week of 2/11/25 through 2/15/25. There were no other SN visits documented after 2/15/25 through the record review period ending on 3/6/25. 3. There was no documentation in the clinical record that the physician was notified of the missed visits or to alter the plan of care. G. Review of Patient 5's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 11/20/24 through 1/18/25, and 1/19/25 through 3/19/25 included orders for SN 2 times a week for 9 weeks. 2. Documentation revealed the SN completed visits 3 times each week from 12/29/24 through 2/22/25. 3. There was no documentation of the reason to justify the need to increase SN visits. 4. There was no documentation in the clinical record the physician was notified to alter the frequency of SN visits. H. Review of Patient 6's clinical record revealed: 1. The Home Health Certification and Plan of Care (POC) for the certification period of 11/13/24 through 1/11/25, returned as signed by the patient's physician on Friday, 11/22/24 at 08:04:58 AM. The POC included updated wound orders which included SN for wound care on Monday (M), Wednesday (W), and Friday (F). 2 . An email dated 11/22/24 was sent to the patient's nurse at 8:51 AM, with the physician-signed and updated Home Health Certification and Plan of Care. 3. Only two SN visits were conducted 11/24/24- 11/30/24; one on M,11/25/24 and one on F, 11/29/24. 4. There was no documentation the physician was notified of the missed visit on W, 11/27/24, or to clarify/reduce the frequency for wound care visits for 11/24/24 through 11/27/24. I. During an interview on 3/11/25 at 12:15 PM, the Administrator confirmed for Patient's 2, 3, 4, 5, and 6 the agency staff failed to: 1. Follow the plan of care for the ordered frequency of visits. 2. Update the physician to change or clarify the frequency of visits. 3. Reschedule missed visits. 4. Resolve the cause of missed visits to ensure the services provided met the patient care needs.

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, policy and procedure review, and staff interview, the agency failed to ensure all physician orders were accurately recorded in the patient's plan of care for 1 of 1 patient who received wound care (Patient 6). Total patient sample was 8. Total patient census was 49. Findings are: A. Review of the agency policy and procedure titled Plan of Care Policy and Procedures, updated 5/9/22, revealed the plan of care is based on comprehensive assessment and information provided by the client/family and health team members and is developed to meet the individualized, specific patient needs. B. Review of the agency policy and procedure titled Wound Care/Treatment Policy and Procedures, revised 5/20/22, revealed the nurse is responsible for: 1. Reporting/consulting with patient's primary care physician or wound specialist regarding any changes to the skin and wound condition. 2. Accurately documenting the wound assessment and management plan. C. Review of Patient 6's clinical record revealed: 1. Referral document orders from Nebraska Medicine Wound and Ostomy Clinic, dated 11/11/24, to admit Patient 6 to this agency. The referral document included orders to change the Negative Pressure Wound Therapy (NPWT or Wound VAC- a type of wound treatment that uses a wound dressing and negative pressure through a machine that assists with wound closure) to the right heel on Monday (M), Wednesday (W), and Fridays (F), which included the use of: a. soap and water wash, rinse, pat dry, b. Vashe (a type of wound cleanser) irrigation or compress as needed. c. silver nitrate as needed in clinic. d. skin prep, marathon, mastisol (all types of skin protectant and/or adhesive used to secure dressings) as needed to periwound (skin surrounding a wound). e. barrier ring (used to prevent drainage from seeping onto healthy skin) to periwound. f. Prisma (a type of wound dressing) to wound depth. g. Cover with black foam, remote TRAC pad (the portion of the tubing that attaches at one end to the wound dressing and the other end to the Wound VAC) to intact fleshy area on the lower leg. h. 150 millimeters mercury (mmHg) low continuous suction. i. Tubigrip E (a type of compression sock) and small edemawear (a type of compression sock) from base of toes to just below the knee with a hole cut to wear the Wound VAC tubing through so tubing is not rubbing against the leg. 2. The Home Health Certification and Plan of Care (POC) (the plan of care document developed based on patient assessment and referral/admission orders) for the certification period of 11/13/24 through 1/11/25 included orders for Skilled Nurse (SN) 3 times a week for 9 weeks for NPWT. The following items were listed on the referral document orders dated 11/11/24, but not included on the POC: a. Vashe irrigation or compress as needed. b. silver nitrate as needed in clinic. c. skin prep, marathon, mastisol as needed to periwound. d. remote TRAC pad to intact fleshy area on the lower leg. e. Tubigrip E and small edemawear from base of toes to just below the knee with a hole cut to wear the Wound VAC tubing through so tubing is not rubbing against the leg. f. The POC included additional instructions to use aseptic (a set of procedures used to prevent contamination) technique to clean wound with normal saline, pat dry, apply Silvadene cream (used to prevent wound infections) to wound, cover with a 4 by 4 gauze, wrap with kerlix (a rolled gauze), and secure with tape. There was no order for these additional instructions in the patient's clinical record. C . During an interview on 3/11/25 at 12:15 PM, the wound care information documented on Patient 6’s Home Health Certification and Plan of Care did not match the referral document orders dated 11/11/24, which were used to admit the patient to the agency.

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, policy and procedure review, and staff interview, the agency failed to ensure wound care treatments were completed as ordered for 1 of 1 patient (Patient 6) patient who received wound care treatments. Total patient sample was 8. Total patient census was 49. Findings are: A. Review of the agency policy and procedure titled Wound Care/Treatment Policy and Procedures, revised 5/20/22, revealed the nurse is responsible for: 1. Adhering to the patient's individualized skin and wound care management plan. 2. Reporting/consulting with patient's primary care physician or wound specialist regarding any changes to the skin and wound condition. 3. Accurately documenting the wound assessment and management plan. B. Review of Patient 6's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 11/13/24 through 1/11/25 included orders for Skilled Nurse (SN) 3 times a week for 9 weeks to change Negative Pressure Wound Therapy (NPWT or Wound VAC- a type of wound treatment that uses a wound dressing and negative pressure through a machine that assists with wound closure) to the right heel on Monday (M), Wednesday (W), and Fridays (F). 2. Faxed orders received from Nebraska Medicine Wound and Ostomy Clinic, dated 11/18/24 at 11:45:52 AM, with wound care order changes. The wound care orders include- wound care 2 times a week to right heel, use soap and water wash, rinse, and pat dry. Place Hydrofera Blue (a type of antibacterial wound dressing) wicked into the wound with tail sticking out for easy removal, cover with mepilex border (a highly absorbent foam dressing). Tubigrip E (a type of compression sock) and small edemawear (a type of compression sock) from base of toes to just below the knee. 3. An email sent from the Business Office Manager (BOM) to the SN, dated 11/18/24 at 12:15 PM, to notify the SN of the wound care order change. 4. Nursing Visit Notes, dated 11/18/24 (at a 1:00 PM visit) and 11/21/24, revealed the SN did not implement the orders for wound care received on 11/18/24 at 11:45:52 AM. 5. A faxed copy of The Home Health Certification and Plan of Care (POC) for the certification period of 11/13/24 through 1/11/25, corrected, revised and signed by the ordering physician on 11/22/24. The faxed copy was received by the agency at 08:04:58 AM on 11/22/24. The POC included updated orders as follows: Wound care has been updated to normal saline moistened Hydrofera Blue to the wound, covered with a mepilex border, change M, W, F. 6. An email from the BOM to the SN, dated 11/22/24 sent at 8:51 AM, to notify the SN of the wound care order change. 7. Nursing Visit Notes dated 11/25/24 (M) and 11/29/24 (F). The SN did not complete wound care on 11/27/24 (W). 8. There was no documentation of the missed wound care treatment, the reason for the missed wound care treatment, or that the physician was notified of the missed wound care treatment on 11/27/24 (W). C . During an interview on 3/11/25 at 12:15 PM, the Administrator confirmed when an order is received in the agency office, the patient's nurse is notified via email, the SN is to read their emails throughout the day, and if an order is changed the SN is to begin following the new order. The Administrator confirmed Patient 6's SN did not follow wound care orders as received 11/18/24, 11/22/24, and 11/27/24.

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 record review, review of the agency Quality Assurance Binder, policy and procedure review, and staff interview, the agency Quality Assurance and Performance Improvement Program (QAPI) failed to identify, track, analyze, and develop measurable goals and failed to maintain data to evaluate the effectiveness of the agency identified Performance Improvement Plans (PIP) to ensure quality care, services, and agency processes are maintained, and failed to have in their policy and procedure a process for identifying and determining the need to alter their PIPs when the PIP goals were not met. These failures resulted in deficient practices. The total patient census was 49 agency. Findings are: A. Review of the agency policy and procedure titled Quality Assessment and Performance Improvement (QAPI) Policy and Procedures, revised 5/2/22, revealed: 1. The agency was to develop, implement, evaluate, and maintain an effective, ongoing, agency-wide data driven QAPI program. 2. A purpose of the program was to ensure that improvements are sustained. 3. The program will be able to show measurable improvements. 4. The program will focus on high risk, high volume, problem prone areas. 5. The policy did not have a process for identifying and determining the need to alter their PIPs, when the PIP goals were not met. B. Review of the agency QAPI binder revealed: 1. The agency identified and had a PIPs in place, updated 1/30/24, which included wound care documentation, following wound care orders, and ensuring wound care orders are available within the patient chart. 2. There was no documentation of the data utilized for analysis, tracking, and trending, and failed to have measurable goals for each PIP. 3. There was no documentation the agency conducted re-analysis to determine the need to alter their PIPs to ensure QAPI goals were met. C. Review of clinical records revealed deficient practices for wound care were cited during this recertification survey at G576 and G580. D. During an interview on 3/11/25 at 12:15 PM, the Administrator confirmed the agency's Quality Assurance and Performance Improvement Program (QAPI) failed to identify, track, analyze, and develop measurable goals and failed to maintain data to evaluate the effectiveness of the agency identified Performance Improvement Plans (PIP) to ensure quality care, services, and agency processes are maintained, and failed to have in their policy and procedure a process for identifying and determining the need to alter their PIPs when the PIP goals were not met. These failures resulted in deficient practices

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: Deficiencies cited at G774, G798, and G808 Findings are: G774 Based on record review, policy and procedure review, and staff interview, the agency failed to ensure 2 of 3 home health aides (HHA, HHA- G and HHA -H) sampled received 12 hours of in-service training during 2023 and 2024. The agency employs 7 HHAs. G798 Based on record review, policy & procedure review and staff interview the agency failed to ensure the Home Health Aide (HHA) plan of care (POC) was individualized to meet the patient specific needs for 1 of 3 (Patient 2) patients who received HHA services. Total patient sample was 8. Total patient census was 49. G808 Based on record review, policy and procedure review, and staff interview, the agency failed to conduct an on-site visit by a Registered Nurse (RN), to the patient’s home every 14 days, to ensure the Home Health Aide (HHA) followed the patient's plan of care, and to ensure the HHA services meet the patient’s needs for 2 of 3 patients who received HHA services (Patient 2 and 3). Total patient sample was 8. Total patient census was 49.

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to ensure 2 of 3 home health aides (HHA, HHA- G and HHA -H) sampled received 12 hours of in-service training during 2023 and 2024. The agency employs 7 HHAs. Findings are: A. Review of the agency policy and procedure titled, Inservice Education/Staff Development, revised 5/20/22, revealed: 1. The HHA must complete twelve hours per year from the date of hire either in lecture, video in-services, or in the patient home while providing care. 2. Staff may attend developmental programs outside the agency and must submit documentation of attendance which will be included in their employee file. 3. Records of in-service education programs will be documented and maintained. B. Review of the personnel files for HHA- G and HHA- H revealed there was no documentation of any in-service training completed during 2023 and 2024. C. During an interview on 3/10/25 at 3:00 PM, the Business Office Manager confirmed there was no documentation of in-service training completed by HHA- G and HHA -H during 2023 and 2024.

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, policy & procedure review and staff interview the agency failed to ensure the Home Health Aide (HHA) plan of care (POC) was individualized to meet the patient specific needs for 1 of 3 (Patient 2) patients who received HHA services. Total patient sample was 8. Total patient census was 49. Findings: A. The agency policy & procedure titled Home Health Aide Care Plan, updated 5/6/22, revealed: The Home Health Aide (HHA) Care Plan was to identify the duties the HHA was expected to perform such as, but not limited to: 1. Personal care; 2. Bathing; 3. Ambulation and Exercise; 4. Household services essential to healthcare at home; 5. Assistance with medication reminders, that the patient self-administers; and 6. Meal planning and preparation if this was supportive of the patient’s health maintenance and promotion. B. Review of Patient 2’s medical record revealed: 1. The Home Health Certification and Plan of Care for the period of 1/21/25 through 3/1/25 included orders for HHA every day to assist with bathing, light meal prep, and tasks of daily living with the supervision of a Registered Nurse (RN). 2. HHA Notes (developed from the HHA POC) revealed the patient assigned tasks include assist with shower and make bed/change [linens]. No other tasks were assigned to the HHA. The frequency of shower was not indicated. C. During an interview on 3/6/25 at 11:00 AM, Licensed Practical Nurse (LPN)- D, revealed that HHA services provided to Patient 2 included dressing assist, applying compression socks and pants, providing oral care, cooking, cleaning, shower 2-3 times per week, making and changing bed [linens], incontinent cares, and toileting. D. LPN-D provided HHA services to patient 2. E. During an interview on 3/11/25 at 12:15 PM, the agency Administrator confirmed the HHA POC for Patient 2 was not individualized to meet the patient's specific needs provided by the LPN.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This ELEMENT is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to conduct an on-site visit by a Registered Nurse (RN), to the patient’s home every 14 days, to ensure the Home Health Aide (HHA) followed the patient's plan of care, and to ensure the HHA services meet the patient’s needs for 2 of 3 patients who received HHA services (Patient 2 and 3). Total patient sample was 8. Total patient census was 49. Findings are: A. Review of the agency policy and procedure titled Home Health Aide Supervisory Visits, dated 5/6/22, revealed: 1. Supervisory visits, by an RN were to be conducted every 14 days to assess the relationship and determine whether patient goals are being met. 2. Supervisory visits were to be documented in the patient's chart on the Home Health Aide Supervision form per the agency policy. B. Review of Patient 2’s clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification periods of 11/22/24 through 1/20/25 and 1/21/25 through 3/21/25 included orders for HHA services daily starting 11/22/24, Skilled Nurse (SN) 1 visit per week for 9 weeks. 2. There was no documentation of an onsite supervisory visit conducted by an RN to the patient’s home from 12/29/24 through 3/1/25 (63 days) C. Review of Patient 3’s clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification periods of 11/25/24 through 1/23/25 and 1/24/25 through 3/24/25 included orders for HHA services 3 times per week starting 11/25/24, and Skilled Nurse (SN) 1 visit per week for 9 weeks. 2. There was no documentation of an onsite RN supervisory visit to the patient’s home from 12/29/24 through 3/1/25 (63 days). D. During an interview on 3/11/25 at 12:15 PM, the Administrator confirmed RN supervisory visits of the HHA were not conducted every 14 days to determine if the patient goals were being met for Patients 2 and 3.

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: Deficiencies cited at G948 and G958 Findings are: G948 Based on clinical record review, Administrator job description, Quality Assurance and Performance Improvement Review, personnel file review, and staff interview, the agency Administrator failed to ensure the regulatory and statutory requirements and agency policy and procedures were followed by the agency. Total patient census was 49. The agency employs 18 direct and contracted staff. G958 Based on record review, personnel file review, job description review, and staff interview, the clinical manager failed to provide oversight of patient care services and personnel. Total patient census was 49. The agency employs 18 direct and contracted staff.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on clinical record review, Administrator job description, Quality Assurance and Performance Improvement Review, personnel file review, and staff interview, the agency Administrator failed to ensure the regulatory and statutory requirements and agency policy and procedures were followed by the agency. Total patient census was 49. The agency employs 18 direct and contracted staff. Findings are: A. Review of the agency job description titled Position: Administrator, updated 10/18/23, revealed some of the Administrator duties include but are not limited to planning, developing, and directing the programs, services, activities and employees of the agency. The Administrator is also responsible for ensuring compliance with federal and state regulations governing home health care services and directing daily business activities of the agency. B. Review of clinical records revealed deficient practice cited at: G520 G572 G576 G580 G798 G808 G1024 M150 C. Review of agency personnel files revealed deficient practice cited at: G774 and E0037 D. Review of agency records revealed a deficient practice cited at: G642 and G958 E. During an interview on 3/11/25 at 12:15 PM, the Administrator confirmed the agency Administrator is responsible for planning, developing, and directing the programs, services, activities and employees of the agency. The Administrator is also responsible for ensuring compliance with federal and state regulations governing home health care services and directing daily business activities of the agency.The Administrator further confirmed they failed to complete these duties as evidenced by the deficient practices being cited during this survey.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on record review, personnel file review, job description review, and staff interview, the clinical manager failed to provide oversight of patient care services and personnel. Total patient census was 49. The agency employs 18 direct and contracted staff. Findings are: A. Review of the agency job description titled Position: Clinical Manager (CM), updated 10/18/23, revealed some of the CM duties include, but are not limited to: 1. Manage, supervise, coordinate, evaluate, and develop client care teams to ensure quality care delivery, and appropriate case management. 2. Ensure accuracy, completeness and timeliness of clinical documentation. 3. Monitor open and closed charts regularly. 4. Providing educational programs. B. Review of clinical records revealed deficient practice cited at: G520 G572 G576 G580 G798 G 808 G1024 M150 C. Review of agency personnel files revealed deficient practice cited at: G774 and E0037 D. Review of agency records revealed a deficient practice cited at G642. E. During an interview on 3/11/25 at 12:15 PM, the Administrator confirmed the duties of the CM include managing, supervising, coordinating, evaluating, and developing client care teams to ensure quality care delivery, and appropriate case management, ensuring accuracy, completeness and timeliness of clinical documentation, monitoring open and closed charts regularly, and providing educational programs. The Administrator also confirmed the CM did not complete these duties as evidenced by the deficient practices cited during this survey.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to ensure all clinician notes were complete, authenticated, and dated by the clinician providing the service for 6 of 8 (Patient 1, 2, 3, 4, 7 and 8) clinical records reviewed and failed to have a process in place to ensure authentication occurred when the electronic medical record system did not allow the clinician to electronically sign and date visit notes. The census was 49. Findings are: A. Review of the agency policy and procedure titled Clinical Documentation, undated, revealed: 1. All skilled services provided are to be documented in the clinical record. 2. A separate note was to be completed for each visit, signed and dated by the appropriate professional. 3. The documentation was to be completed by the direct caregiver and monitored by the skilled professional responsible for managing the patient's care. B. Review of the agency policy and procedure titled, Home Health Aide: Documentation, updated 7/22/22 revealed the home health aide (HHA) was to utilize the appropriate HHA flow sheet to document the services rendered. C. Review of Patient 1's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 12/11/24 through 2/8/25 included orders for Physical Therapy (PT) and Occupation Therapy (OT) to evaluate and treat. 2. A PT evaluation note with a visit date of 12/20/24, was not completed, signed, or dated, by the PT. 3. OT visit notes with visit dates of 12/23/24, 12/26/24, 12/30/24,1/2/25, 1/6/25 1/13/25, 1/15/25, 1/20/25, 1/22/25, 1/27/25, 1/29/25, 2/3/25, 2/5/25 were not signed, or dated by the OT completing the services. D. Review of Patient 2's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 11/22/24 to 1/20/25 and 1/21/25 through 3/24/25 included orders for Skilled Nurse (SN) 1 time a week for 9 weeks and HHA daily. 2. The record review period of 12/29/24 through 3/6/25 revealed the HHA failed to document the service provided to the patient on all HHA notes and/or failed to electronically sign the HHA notes. 3. The SN failed to sign and/or complete documentation for visits dated 12/31/24, 1/2/25, 1/6/25, 1/8/25, 1/14/25, 1/16/25, and 1/20/25. E. Review of Patient 3's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 11/25/24 through 1/23/25 and 1/24/25 through 3/24/25 included orders for SN 1 time a week for 9 weeks. 2. An order dated 2/26/25 for OT for home safety, activities of daily living, range of motion/strengthening, and functional mobility. 3. The SN failed to sign and/or complete documentation for visits dated 12/30/24, 1/6/25, 1/13/25, and 1/20/25. 4. An OT evaluation with a visit date of 3/3/25 was not signed and dated by the OT. F. Review of Patient 4's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 2/11/25 through 4/11/25 included orders for OT to evaluate and treat. 2. The OT failed to sign and date visit notes with visit occurring on 2/20/25, 2/25/25, and 2/27/25. G. Review of Patient 7's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 6/14/24 through 8/12/24 included orders for OT for referral (frequency to be determined). 2. The OT failed to sign and date visit notes with visits occurring on 7/2/24, 7/9/24, 7/11/24, 7/16/24, 7/18/24, and 7/23/24 H. Review of Patient 8's clinical record revealed: 1. Home Health Certification and Plan of Care for the certification period of 2/14/25 through 4/14/25 included orders for OT to evaluate and treat. 2. The OT failed to sign and date visit notes with visits occurring on 2/20/25, 2/26/25, and 3/3/25. I. During an interview on 3/11/25 at 12:15 PM, the Administrator confirmed the OT, PT, HHA, and/or SN failed to complete, sign and date visit notes for Patient 1, 2, 3, 4, 7, and 8. The Administrator also confirmed the electronic medical system used by the agency does not allow the OT to sign and date their visit notes and the agency does not have a writtten process to ensure visit notes are manually signed when the electronic medical record system does not allow for an electronic signature by a clinician.

Ambi's Home Health Care, LLC is in compliance with the requirements of 42 CFR 484.102 Condition of Participation for Home Health Agencies,

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, policy and procedure review, and staff interview, the agency failed to ensure all orders are included on the patient's plan of care for 1 of 7 clinical records reviewed (Patient- 1). The census was 63. Findings are: A. Review of the agency policy and procedure titled, Plan of Care Policy and Procedure, no date indicated, revealed the plan of care was to be updated at least every 60 days and was to include medications and treatments. B. Review of Patient-1's clinical record revealed: 1. A Nurse Visit Note dated 3/2/22 included documentation that the patient had a new order for omeprazole (a medication used to treat heartburn by reducing acid in the stomach). 2. The revised/updated Home Health Certification and Plan of Care for the certification period of 3/15/22 through 5/15/22 did not include the new order for omeprazole. 3. There was indication the physician was updated to add and/or discontinue the medication to ensure the plan of care contained current medication orders. C. During an interview on 4/26/22 at 9:35 AM, the Administrator confirmed Patient-1's revised/updated plan of care did not include orders for the omeprazole and staff did not follow the agency policy and procedure to include all medication orders on the patient's physician approved plan of care.

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, policy and procedure review, and staff interview, the agency failed to ensure treatments and services were completed as ordered on the plan of care for 1 of 7 clinical records reviewed (Patient-6). The census was 63. Findings are: A. Review of the agency policy and procedure titled, Plan of Care Changes Policy and Procedures, revised 5/1/21, revealed it is the agency policy to ensure the plan of care is followed and any changes are communicated to all parties. B. Review of Patient-6's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 1/27/22 through 3/27/22, included orders for Physical Therapy (PT) and Occupational Therapy (OT) 2 to 3 times per week for 9 weeks. 2. There was no documentation in the clinical record that a PT or OT visit was conducted with the patient from 1/27/22 (patient admit date) through 3/21/22 (date of discharge from agency). 3. There was no documentation in the clinical record that the patient declined (refused) PT and/or OT services. 4. There was no documentation the physician was notified the patient refused to participate with or to discontinue PT and/or OT services until 3/21/22 when an order was received to discontinue home health services due to patient's non-compliance with the plan of care (54 days after start of home health services). C. During an interview on 4/27/22 at 10:30 AM, the Administrator confirmed PT and OT services were not provided to Patient-6, there was no documentation in the clinical record that the patient refused PT and OT services, and no documentation in the clinical record the physician was notified of patient refusals to participate with or to discontinue PT and OT services.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to ensure staff followed the agency policy and procedure for the coordination of the delivery of care among all services providing care for 2 of 7 clinical records reviewed (Patient-4 and Patient-6). The census was 63. Findings are: A. Review of the agency policy and procedure titled, Coordination of Client Services, no date indicated, revealed: 1. The agency was to coordinate care with nursing, therapy, and home health aide services, whether services provided directly or under arrangement. 2. Agency was to communicate with all physicians writing orders on the patient's plan of care. 3. Documentation was to address the coordination activities. 4. Involvement of the care team must be apparent in the patient health record. B. Review of Patient-4's clinical record revealed: 1. A Nursing Visit Note by a licensed practical nurse (LPN), dated 3/25/22, documenting a hospitalization from "Saturday 7pm until Tuesday noon". 2. There was no documentation in the clinical record that once the LPN received information regarding a hospital stay the patient's clinical manager was notified of the hospitalization. 3, There was no documentation in the clinical record of coordination with the patient's physician following the patient's hospitalization. C. Review of Patient-6's clinical record revealed: 1. The Home Health Certification and Plan of Care for the certification period of 1/27/22 through 3/27/22 included orders for Physical Therapy (PT) and Occupational Therapy (OT) 2 to 3 times per week for 9 weeks. 2. There was no documentation of a PT or OT visit conducted from 1/27/22 (patient admit date) through 3/21/22 (patient discharge date). 3. A Coordination Note dated 3/27/22 by the Administrator. The note indicated contact with therapy revealed therapy services did not receive the order for PT and OT during the certification period. 4. There was no documentation in the clinical record of coordination with the patient's physician to revise the plan of care to discontinue therapy services. D. During an interview on 4/27/22 at 10:30 AM, the Administrator confirmed the agency staff did not follow the policy and procedure for the coordination of the delivery of care among all services and the physician providing care to Patient-4 and Patient-6.

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review, policy and procedure review, and staff interview, the agency failed to have a process in place to ensure the agency's Quality Assessment and Performance Improvement (QAPI) program continued to be completed during periods of time when agency staff conducted work from home to ensure improvements were sustained. This failure had the potential to affect all agency patients. The sample size was 7, the census was 63. Findings are: A. Review of the agency policy and procedure titled, Quality Assessment and Performance Improvement (QAPI) Policy and Procedure, revised 8/20/21, revealed: 1. The agency was to develop, implement, evaluate, and maintain an effective QAPI program to monitor effectiveness and safety of services, identify opportunities for improvement, and to measure agency and contractors success and ensure that improvements are sustained. 2. The agency did not have a process for continuing the QAPI process when staff worked away from the office for extended periods of time (such as during the pandemic). B. Review of clinical records revealed deficient practice identified at: 1. G576 for 1 of 7 patient records reviewed (Patient-1). 2. G580 for 1 of 7 patient records reviewed (Patient- 6). 3. G608 for 2 of 7 patient records reviewed (Patient-4 and Patient-6). 4. G798 for 3 of 4 patient records reviewed who received home health aide services (Patient- 1, 3, and 5). C. During an interview on 4/27/22 at 3:30 PM, the Health Information Maintenance Supervisor (HIMS) confirmed: 1. HIMS was working from home since November. HIMS responsible for completing QAPI chart audits. 2. QAPI Patient chart audits are used by the agency to identify potential deficient practices with care, services, and documentation, and include the deficient practices identified in B-1, 2, 3 and 4 above. 3. Chart audits had not been completed during the time HIMS was working from home from November 2021 through the survey exit date. 4. The agency did not have a process in place to ensure QAPI chart audits were completed during times when staff worked from home.

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, policy and procedure review, and staff interview, the agency failed to ensure the Home Health Aide (HHA) plan of care was reviewed and updated every 60 days according to the agency policy and procedure, for 3 of 4 patient records reviewed who received HHA services (Patient- 1, 3, and 5). The total sample size was 7. The census was 63. Findings are: A. Review of the agency policy and procedure titled, Home Health Aide Care Plan, no date indicated, revealed the HHA Care plan was to be developed by a Registered Nurse (RN) or therapist to delegate tasks to the HHA and was to be reviewed by RN at a minimum of every 60 days. B. Review of Patient-1’s clinical record revealed: 1. The Home Health Certification and Plan of Care revealed the start of care was 3/20/21. 2. The Home Health Certification and Plan of Care for the certification periods of 1/14/22 through 3/14/22 and 3/15/22 through 5/15/22 included orders for HHA 3 to 4 hours per day, 3 times per week for 9 weeks. 3. There was no documentation on the Home Health Aide Care Plan for the certification period of 1/14/22 through 3/14/22 and 3/15/22 through 5/15/22 was reviewed and updated by the RN. C. Review of Patient-3's clinical record revealed: 1. The Home Health Certification and Plan of Care revealed the start of care was 6/23/21. 2. The Home Health Certification and Plan of Care for the certification periods of 2/18/22 through 4/18/22 and 4/19/22 through 6/17/22 included orders for HHA 3 hours per day, 3 times per week for 9 weeks. 3. There was no documentation on the Home Health Aide Care Plan for the certification period of 2/18/22 through 4/18/22 and 4/19/22 through 6/17/22 was reviewed and updated by the RN. D. Review of Patient -5's clinical record revealed: 1. The Home Health Certification and Plan of Care revealed the start of care was 1/26/22. 2. The Home Health Certification and Plan of Care for the certification periods of 1/26/22 through 3/26/22 and 3/27/22 through 5/25/22 included orders for HHA 8 hours per day for 9 weeks. 3. There was no documentation on the Home Health Aide Care Plan for the certification period of 3/27/22 through 5/25/22 was reviewed and updated by the RN. E. During an interview on 4/27/22 at 10:30 AM, the Administrator confirmed there was no documentation to ensure the HHA plan of care for Patient-1, 3, and 5 was reviewed and updated by the RN every 60 days according to the agency's policy and procedure.

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, §485.625, §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 review of the agency's Emergency Preparedness Program (EPP), policies and procedures and staff interview the agency failed to review the EPP, failed to complete a community based risk assessment using an all-hazards approach, failed to include in the EPP the method to be utilized for sharing medical information regarding patients, and failed to provide initial and ongoing staff training. Agency census was 101. The deficient practices had the potential to affect all agency staff and patients in the event the emergency plan needed to be initiated. Deficiencies were cited at E004,E006, E033 and E037. Findings are: E004 Based on review of the agency's Emergency Preparedness Program, policies and procedures and staff interview the agency failed to document the risk assessment used to identify all potential hazards, failed to train staff, and failed to test the agency's emergency plan at least annually. E006 Based on policy and procedure and staff interview the agency failed to complete a facility and community based risk assessment that used an all-hazards approach to ensure the agency's Emergency Preparedness Policy and Procedures were developed to include facility and community specific risks and failed to include the assessment in the agency's Emergency Preparedness Program (EPP). E0033 Based on review of the agency's Emergency Preparedness Program (EEP), policies and procedures and staff interview the agency failed to include in the EPP the agency's means for sharing information and medical documentation for patients under the agency's care, as necessary, with other health care providers to maintain continuity of care. E0037 Based on review of the agency's Emergency Preparedness Program (EPP), policies and procedures and staff interview the agency failed to provide initial training to for 9 of 10 employees reviewed (Staff member F, G, I, J, K, M, A, C, and L).

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), §485.625(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 review of the agency's Emergency Preparedness Program, policies and procedures and staff interview the agency failed to maintain and review an Emergency Preparedness (EP) plan for the agency. The deficient practices had the potential to affect all agency staff and patients in the event the emergency plan needed to be initiated. Agency census was 101. A. Review of the agency policy and procedure, titled Emergency Preparedness Management (EPM) Policy, no date indicated, revealed the agency was to have an identified plan in place to ensure the safety and well-being of clients and employees during periods of an emergency or disaster that disrupts agency services. Review of the agency's EPM Plan dated 7/12/2019, revealed no documentation the EPM plan was reviewed and/or revised following formulation on 7/12/2019. B. The agency Administrator during interview on 4/8/2021 at 12:35 PM confirmed there was no documentation to verify the EP policy had been reviewed and/or revised following its formulation on 7/12/2019.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(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 the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[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. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on policy and procedure and staff interview the agency failed to complete a facility and community based risk assessment that used an all-hazards approach to ensure the agency's Emergency Preparedness Policy and Procedures were developed to include facility and community specific risks and failed to include the assessment in the agency's Emergency Preparedness Program (EPP). Agency census was 101. Findings are: A. Review of the agency policy and procedure titled, Emergency Preparedness Management Policy, no date indicated, revealed the agency was to conduct an analysis to identify potential emergencies and the impact on agency operations and demand for services. B. Review of the EPP revealed there was no documentation the agency conducted a facility based or community based risk assessment to identify potential emergencies. C. The Administrator during interview on 4/8/2021 at 12:35 PM, confirmed the agency failed to complete a facility and community based risk assessment that utilized an all-hazards approach to formulate the agency's EPP and failed to include the assessment in the EPP. D. This failure had the potential to affect all agency patients due to the potential of not identifying the emergency situations specific to the patient population.

Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(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]. The communication plan must include all of the following: (4) A method for sharing information and medical documentation for patients under the [facility's] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility's] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). This STANDARD is not met as evidenced by: Based on review of the agency's Emergency Preparedness Program (EPP), policies and procedures and staff interview the agency failed to include in the EPP the agency's means for sharing information and medical documentation for patients under the agency's care, with other health care providers to maintain continuity of care. Agency census was 101. Finding are: A. Review of the agency policy titled Emergency Preparedness Management Policy, no date indicated, revealed the policy did not address a method for sharing information and medical documentation for patients with other health care providers. B. Review of the agency EPP revealed, the plan did not address the agency's method for sharing information or medical documentation for patients with other health care providers. C. The Administrator during interview on 4/7/2021 from 2:00 PM to 4:00 PM confirmed the agency policy and procedure and EPP did not address a method for sharing information and medical documentation for patients with other health care providers.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on review of the agency's Emergency Preparedness Program (EPP), policies and procedures and staff interview the agency failed to provide initial training to 9 of 10 employees reviewed (Staff member F, G, I, J, K, M, A, C, and L). Census was 101. Findings are: A. Review of the policy titled Emergency Preparedness Management Policy, section titled Training, no date indicated, verified agency staff members were to participate in an annual desktop drill to determine the effectiveness and efficiency of the current plan and any forms developed for use in a disaster. The policy did not identify provision of initial or annual training in emergency preparedness policies and procedures to all new and existing staff. B. Review of the personnel files for staff members F, G, I, J, K, M, A, C, and L revealed no documentation of initial and/or annual training regarding the agency's emergency preparedness policies and procedures. C. The Administrator, during interview on 4/7/2021 from 2:00 PM to 4:00 PM, confirmed there was no documentation of initial and/or annual training regarding the emergency preparedness policies and procedures staff for members F, G, I, J, K, M, A, C or L.

An unannounced complaint investigation was completed on 4/8/2021. An allegation was verfied with related and unrelated deficiencies cited including eight (8) condition-level deficiencies at G510, G570, G640, G700, G750, G940, G1008, and E001.

Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) (i) Investigate complaints made by a patient, the patient's representative (if any), and the patient's caregivers and family, including, but not limited to, the following topics: This ELEMENT is not met as evidenced by: Based on review of clinical records, review of the grievance/complaint file, review of agency policy and procedure and staff interview, the agency failed to investigate an allegation made by a patient (Patient 1) regarding mistreatment by agency staff. Sample size was 7 and agency census was 101. Findings are: A. Review of the agency policy and procedure titled, Grievance Procedures, no date indicated, revealed any patient, patient representative, prospective patient, or any agency staff member who has reason to believe he/she has been mistreated, denied services, or discriminated against may file a grievance; staff will be temporarily removed until the investigation is resolved. Adult/Child Protective Services and/or police departments will be notified immediately by the business office manager if it is an allegation of abuse or misappropriation, . Review of documentation by Licensed Practical Nurse(LPN)-L dated 3/14/2021 at 8:00 AM, revealed during the provision of cares for Patient 1, the patient verbalized profanities, used racial slurs toward the LPN and told the LPN to leave and was" ...hitting at me ..." and threatened to hit the LPN with a grabber tool. Documentation by the LPN revealed the patient stated [gender] was going to wrap it (the grabber tool) around the LPN's neck. Documentation revealed Patient 1 told the LPN, using racial slurs [gender] was going to call the police and tell them " ... I assaulted [gender] ..." The LPN documented Patient 1 called the police and when the police officers arrived at the patient's residence they interviewed both the patient and the LPN and completed a report. The LPN documented [gender] left the patient's residence with the police officers and called the the patient's physician to inform the physician what had occurred. B. Documentation on the Grievance/ Complaint Report dated 3/15/2021 by the Administrator, revealed Patient 1 was being " ...inappropriate to employee ... derogatory verbal abuse. Police called" and "Patient was discharged due to recurring incidents with nursing staff." C. Interview with the Administrator on 3/30/2021 at approximately 3:30 PM confirmed, LPN-L had contacted the agency on 3/14/2021 when the situation with Patient 1 occurred and reported to the Health Information Manager (HIM), Patient 1's behaviors and the notification of the police department. The Administrator confirmed the HIM called the Administrator and informed the Administrator of Patient 1's behavior with LPN-L and the involvement of the police department. The Administrator confirmed, during the same interview, there was no additional investigation conducted regarding the occurrence on 3/14/2021 and Patient 1 was discharged from the agency due to a history of behaviors toward staff.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Deficiency cited at G528. Findings are: G528 Based on review of clinical records, review of policy and procedure and staff interview, the agency failed to include the assessment of the patient's current health status for 1 of 7 patients reviewed (Patient 1) as assessments of the patient did not identify the presence of pressure ulcers. Sample size was 7 and agency census was 101. This practice failed to provided the opportunity for patients to receive the cares and services needed.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on review of clinical records, review of policy and procedure and staff interview the agency failed to include the assessment of the patient's current health status for 1 of 7 patients reviewed (Patient 1) as assessments of the patient did not identify the presence of pressure ulcers. Sample size was 7 and agency census was 101. Findings are: A. Review of Patient 1's clinical record revealed the patient was admitted to the agency on 12/26/2018 with diagnoses of insulin dependent diabetes mellitus, hypertension, bilateral amputation of the legs and coronary artery disease. B. Review of Patient 1's clinical record revealed progress notes dated 2/17/2021 by a Wound and Ostomy Clinic for a wound on the buttocks. Review of the progress note revealed the patient was seen in the wound clinic 9/1/2020 and again on 9/29/2020 for an open wound on the right buttock area. The same progress note revealed the patient was referred to the wound clinic again following a physician visit on 1/27/2021 when the physician identified a new open wound on the right buttocks. The same progress note revealed the patient had a Stage 3 (Staging of pressure ulcers is a method of describing pressure ulcer depth and involvement of tissue) pressure ulcer of the perineum; a full thickness wound to the perineum area and the patient had 2 wounds: one to the right upper buttock and one to the right lower buttock C. Review of Patient 1's assessments dated 12/14/2020, 2/4/2021, and 2/9/2021 revealed the patient's skin was intact and the patient had no pressure ulcers. D. Review of Patient 1's Home Health Certification and Plan of Care for the certification periods of 12/15/2020 to 2/12/2021 and 2/13/2021 to 4/13/2021 did not address the presence of the patient's pressure ulcers as identified in the progress notes from the Wound and Ostomy clinic and there were no physician orders for the treatment of the patient's pressure ulcers. E. Review of documentation in the Nursing Visit Notes by Licensed Practical Nurse (LPN)-L from 12/15/2020 through 1/27/2021, 1/29/21 through 1/31/2021, 2/3/2021 through 2/8/2021, 2/12/2021 through 2/17/2021, 2/19/2021 through 3/14/2021 revealed the LPN conducted wound care for the patient daily. There was no documentation of the location of the wound, a description of the wound or the treatment provided by the LPN. F. Review of the agency policy and procedure titled Encoding and Reporting of OASIS data, no date indicated, revealed each patient must receive a patient specific comprehensive assessment that accurately reflects the patient's current health status and includes information that may be used to demonstrate the patient's progress toward achievement of desired outcomes, and must meet the patient's medical, nursing, rehabilitative, social and discharge planning needs. G. The agency Administrator and LPN-E on 4/7/2021 at approximately 4:30 PM confirmed during interview, Patient 1's assessments conducted on 12/14/2020, 2/4/2021 and 2/9/2021 did not identify the patient had pressure ulcers and there was no documentation in the clinical record of assessment or identification of Patient 1's pressure ulcers by the agency staff.

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: Deficiencies cited at G572, G576, G580, and G590. G572 Based on review of clinical records, review of policy and procedure and staff interview the agency failed to provide services to 7 of 7 patients ( Patients 1, 2, 3, 4, 5, 6, and 7) as written in the individualized plan of care and as outlined in physician orders. The agency failed to notify the physician caring for the patient of the need to alter the plan of care. Sample size was 7 and agency census was 101. This practice failed to allow the physician to be aware of and make potential changes to the services provided to the patients. G576 Based on review of clinical records, review of policy and procedure and staff interview the agency failed to record the physician orders for wound care on the plan of care for 3 of 3 patients reviewed with wounds (Patient 1, 3, and 5). Sample size was 7 and agency census was 101. G580 Based on review of clinical records, review of policy and procedure and staff interview the agency failed to provide drugs as ordered by the physician for 1 of 7 patients reviewed (Patient 1). Sample size was 7 and census was 101. G 590 Based on review of clinical records, review of policy and procedure and staff interviews the agency failed to promptly alert the patient's physician(s) to changes in the patient's condition or needs and failed to inform the physician of the need to alter the plan of care for 7 of 7 patients reviewed (Patients 1, 2, 3, 4, 5, 6, and 7). Sample size was 7 and agency census was 101.

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 review of clinical records, review of policy and procedure and staff interview the agency failed to provide services to 7 of 7 patients (Patients 1, 2, 3, 4, 5, 6, and 7) as written in the individualized plan of care and as outlined in physician orders. The agency failed to notify the physician caring for the patient of the need to alter the plan of care. Sample size was 7 and agency census was 101. This practice failed to allow the physician to be aware of and make potential changes to the services provided to the patients. Findings are: A. Review of the agency policy and procedure, titled Plan of Care, no date indicated, revealed home care services are to be furnished under the supervision and direction of the patient's physician and the plan of care is to address the care, treatment and services to be provided. B. Review of the policy and procedure titled Plan of Care Changes, no date indicated, revealed the policy of the agency is to ensure the plan of care is followed and any changes are communicated to all interested parties; the Director of Nursing (DON) will update the plan of care and the DON will follow procedure to notify all staff of updates to the plan of care. C. Review of Patient 1's Nursing Visit Notes for 12/15/2020 to 3/14/2021 revealed Licensed Practical Nurse (LPN)-L provided wound care for the patient on a daily basis. Review of the Home Health Certification and Plan of Care for the certification periods of 12/15/2020 to 2/12/2021 and 2/13/2021 to 4/13/2021, revealed there were no physician orders for the provision of wound care. D. Interview, with the Administrator on 3/30/2021 at 11:35 AM, confirmed Patient 1's Home Health Certification and Plan of Care for the certification periods of 12/15/2020 to 2/12/2021 and 2/13/2021 to 4/13/2021 did not include physician orders for the provision of wound cares. The Administrator confirmed during the same interview, the orders for the patient's wound care were " ...hanging on the wall in the patient's home ..." E. Review of Patient 1's clinical record revealed the patient was readmitted to the agency on 2/3/2021 following hospitalization. Review of the patient's Nursing Visit Note dated 2/3/2021 at 4:00 PM revealed the patient returned from the hospital on 2/3/2021 and the patient had a drainage tube in [gender] back. There were no physician orders regarding the cares to be provided by the agency staff to the drainage tube in the patient's back. F. Review of Patient 2's Home Health Certification and Plan of Care for the certification periods of 10/30/2020 to 12/28/2020, 12/29/2020 to 2/6/2021 and 2/7/2021 to 4/27/2021 revealed the patient was to receive skilled nurse visits 2 times per week for 9 weeks; Physical Therapy (PT) for evaluation/treatment 2-3 visits per week for 9 weeks; Occupational Therapy (OT) for evaluation and treatment 2-3 visits per week for 9 weeks; and Home Health Aide (HHA) services 5 days per week, for 2 hours per visit. Review of Patient 2's clinical record revealed there were no skilled nursing visits, HHA, PT or OT visits provided to the patient the week of 11/1/2020 through 11/7/2020. Review of Patient 2's clinical record revealed the documentation of weekly visits to the patient were conducted by agency staff as follows per week: Week of 11/8/2020 - 11/14/2020: HHA visits on 11/10/20, 11/11/20, 11/12/220, 11/13/20 and 11/14/2020; There were no PT or OT visits for evaluation or treatment; Week of 11/15/2020 - 11/21/2020: No PT or OT visits for evaluation or treatment; Week of 11/22/2020 - 11/28/2020: HHA 11/24/2020; There were no PT or OT visits; Week of 12/6/2020- 12/12/2020: HHA visits 12/8/2020, 12/9/2020 and 12/10/2020; Week of 12/13/2020 - 12/19/2020: HHA visits 12/14/2020, 12/15/2020, 12/16/2020, and 12/18/2020; Week of 12/20/2020 - 12/26/2020 HHA visits 12/23/2020 and 12/24/2020; Week of 12/27/2020 - 1/2/2021: HHA visits 12/30/2020 and 12/31/2020; OT visit 12/28/2020; Week of 1/3/2021 - 1/9/2021: HHA visits 1/4/2021, 1/6/2021 and 1/8/2021; Week of 1/10/2021 - 1/16/2021: HHA visits 1/11/2021 and 1/14/2021; Week of 1/17/2021- 1/23/23021: HHA visits 1/18/2021, 1/21/2021 and 1/22/2021; Week of 1/24/2021 - 1/30/2021: HHA visits 1/27/2021 and 1/28/2021 and 1 OT visit 1/27/2021; Week of 1/31/2021 - 2/6/2021: HHA visits 2/3/2021, and 2/5/2021, no documented OT visits; Week of 2/7/2021 - 2/13/2021: HHA visits 2/8/2021, 2/10/2021 and 2/12/2021 and 1 OT visit 2/8/2021; Week of 2/14/2021 - 2/20/2021: HHA visits 2/17/2021 and 2/19/2021 and 1 PT visit 2/17/2021; Week of 2/21/2021 - 2/27/2021: HHA visits 2/22/2021, 2/24/2021 and 2/26/2021, and a skilled nurse visit 2/23/2021; Week of 2/28/2021- 3/6/2021: HHA visits 3/1/2021, 3/3/2021 and 3/5/2021; Week of 3/7/2021 - 3/13/2021: HHA visits 3/8/2021, 3/10/2021, and 3/12/2021; Week of 3/14/2021 - 3/20/2021: HHA visits 3/15/2021 and 3/20/21; and Week of 3/21/2021 - 3/27/2021: HHA visits 3/22/2021, 3/24/2021 and 3/26/2021. G. The Administrator and Licensed Practical Nurse (LPN)-E, during interview on 4/7/2021 from 3:30 to 4:30 PM, confirmed visits by the skilled nurse, HHA, PT and OT were not conducted as ordered by the physician from 11/8/2020 to 3/27/2021 and there were no physician orders to alter Patient 2's plan of care. H. Review of Patient 3's Home Health Certification and Plan of Care for the certification period of 2/17/2021 to 4/17/2021 revealed the patient was to receive skilled nursing 7 visits per week for 9 weeks and HHA visits 7 times per week for 9 weeks. Review of Patient 3's clinical record revealed no documentation of HHA visits conducted between 2/17/2021 and 4/1/2021. I. Interview, with LPN-E on 4/1/2021 at 12:30 PM, confirmed Patient 3 did not receive the services of a HHA as ordered by the physician and the patient's physician was not notified of the need to alter the patient's plan of care. J. Review of Patient 4's Home Health Certification and Plan of Care for the certification period of 3/8/2021 to 5/6/2021 revealed the patient was to receive the services of a skilled nurse 1 time per week for 9 weeks, PT 4 visits per week for 9 weeks, OT 2 to 3 visits per week for 9 weeks and HHA 3 times per week for 9 weeks. K. Review of Patient 4's clinical record revealed no documentation of skilled nurse visits for the patient from 3/8/2021 to 3/31/2021; and there was no documentation PT or OT visits were conducted for the patient as ordered by the physician. L. The Administrator, during interview on 4/6/2021 at 11: 45 AM, confirmed Patient 4 did not receive the services of skilled nursing, PT and OT as ordered by the physician and the patient's physician was not notified of the need to alter the patient's plan of care. M. Review of Patient 5's Home Health Certification and Plan of Care for the certification period of 12/12/2020 to 2/9/2021 and 2/10/2021 to 4/10/2021, revealed the patient was to receive the services of a HHA daily for 9 weeks. N. Review of Patient 5's clinical record revealed the patient did not receive the services of a HHA on 12/28/2020, 1/2/2021, 1/11/2021 and 1/16/2021. O. The Administrator, during interview on 4/6/2021 at 3:05 PM, confirmed Patient 5 did not receive the services of a HHA daily as ordered by the physician and the patient's physician was not notified of the need to alter the patient's plan of care. P. Review of Patient 6's Home Health Certification and Plans of Care for the certification period of 12/17/2020 to 2/15/2021 revealed the patient was to receive the services of a skilled nurse (SN) 3 times per week for 9 weeks, PT 2 to 3 visits per week for 9 weeks, OT 2 to 3 visits per week for 9 weeks and Speech Therapy (ST) 2 to 3 visits per week for 9 weeks and HHA services daily. Q. Review of Patient 6's clinical record revealed the patient did not receive the services of ST as ordered by the physician and the physician was not notified of the need to alter the patient's plan of care. R. LPN-E, during interview on 4/5/2021 at 3:10 PM, confirmed ST services were not provided to Patient 6 as ordered by the physician on 12/17/2020, and the physician was not notified of the need to alter the patient's plan of care. S. Review of Patient 6's clinical record revealed visits were conducted by agency staff as follows: The week of 12/17/2020 - 12/19/2020: skilled nurse visit 12/17/2020; No PT or OT visits; The week of 12/20/2020 to 12/26/2020: No OT visits were conducted; and The week of 1/17/2021 - 1/23/2021: No PT visits. T. Review of Patient 6's clinical record revealed no physician order to alter the frequency of the SN, HHA, PT or OT visits to be conducted for the patient as outlined in the patient's plan of care. U. Review of Patient 6's Home Health Certification and Plans of Care for the certification period of 2/16/2021 to 4/15/2021 revealed the patient was to receive the services of skilled nurse 3 times per week for 9 weeks, PT 2 to 3 visits per week for 9 weeks, OT 2 to 3 visits per week for 9 weeks and daily HHA visits for 9 weeks. V. Review of Patient 6's clinical record revealed visits were conducted by agency staff as follows: The week of 2/14/2021 - 2/20/2021: SN visit 2/15/2021, OT visit 2/17/2021, and daily HHA visits; The week of 2/21/2021 - 2/27/2021: SN Visit 2/22/2021, OT visit 2/25/2021, daily HHA visits; The week of 2/28/2021 - 3/6/2021: SN Missed visit forms completed for 3/1/2021 and 3/4/2021; The week of 3/7/2021 - 3/13/2021: SN visit 3/9/2021 and 4 HHA visits 3/8/2021, 3/9/2021, 3/11/2021 and 3/12/2021; The week of 3/14/2021 - 3/20/2021: SN visit 3/15/2012 and Missed visit report for HHA 3/15/2021; HHA Visit 3/16/2021, 3/18/2021 and 3/19/2021; The week of 3/21/2021 - 3/27/2021: A Missed visit report for SN visit 3/22/2021 and 4 HHA visits 3/22/2021, 3/23/2021, 3/25/2021 and 3/26/2021 W. Review of Patient 6's clinical record revealed no physician order to alter the frequency of the SN, HHA, PT or OT visits to be conducted for the patient and as outlined in the patient's plan of care. X. LPN-E, on 4/5/2021 at 3:10 PM during interview, confirmed Patient 6's physician was not notified of the need to alter the plan of care for the patient and there was no physician order to change the frequency of the SN, HHA, PT or OT visits as outlined in the patient's plan of care. Y. Review of Patient 7's Home Health Certification and Plan of Care for the certification period of 2/18/2021 to 4/18/2021 revealed physician orders for the patient to receive the services of a SN 1 time daily for 9 weeks, and HHA 1 time daily for 9 weeks. Z. Review of Patient 7's clinical record revealed visits were conducted by agency staff as follows: The week of 2/18/2021- 2/20/2021: SN visit on 2/18/2021; The week of 2/21/2021 - 2/27/2021: SN visit 2/22/21 and 2/25/2021; The week of 2/28/2021- 3/6/2021: SN visit 3/1/2021 and 3/5/2021; The week of 3/7/2021 - 3/13/2021: SN visit 3/8/2021 and 3/11/2021; The week of 3/14/2021- 3/20/2021: SN visit 3/15/2021 and 3/19/2021; The week of 3/21/2021 - 3/27/2021: SN visit 3/21/2021, 3/22/2021, 3/23/2021, 3/24/2021, 3/25/2021 and 3/27/2021; The week of 3/28/2021- 4/3/2021: SN visit 3/28/2021, 3/29/2021, 3/30/2021, 3/31/2021, 4/1/2021 and 4/2/2021. Review of Patient 7's clinical record revealed there was no documentation the patient's physician was notified of the need to alter the patient's plan of care. AA. The Administrator during interview on 4/7/2021 from 3:00 PM to 4:30 PM confirmed Patient 7's physician was not notified of the need to alter the patient's plan of care and there was no physician's order to change the frequency of the SN visits.

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 review of clinical records, review of policy and procedure and staff interview the agency failed to record the physician orders for wound care on the plan of care for 3 of 3 patients with wounds (Patient 1, 3, and 5). Sample size was 7 and agency census was 101. Findings are A. Review of the agency policy and procedure titled Physician Orders, no date indicated, revealed all medications, treatments and services provided to patients must be ordered by a physician and all medications and treatments that are part of the patient's plan of care must be ordered by the physician. B. Review of the agency policy and procedure titled Wound Management, no date indicated, revealed the nurse is responsible for reporting and consulting with the primary care physician or wound specialist. The same policy and procedure revealed the principles of wound management include identifying the etiology of the wound per the patients physician or wound clinic orders, to reduced and eliminate factors causing a wound per the physician; to select and apply topical treatment/dressings per the physician's order and to plan, implement and evaluate an individual care plan with the patient and/or representative and other health care professionals. C. Review of the agency policy titled Plan of Care, no date indicated, revealed an individualized plan of care signed by the physician shall be required for each patient receiving home health services. The plan of care shall include type, frequency and duration of all services, medications, treatments and procedures. D. Review of the policy titled Plan of Care Changes, no date indicated, revealed the Director of Nursing was to update the plan of care and notify staff of changes in the plan of care. E. Review of Patient 1's Nursing Visit Notes for 12/15/2020 through 3/14/2021 revealed Licensed Practical Nurse (LPN)-L provided wound care for the patient on a daily basis. Review of the Home Health Certification and Plan of Care for the certification periods of 12/15/2020 to 2/12/2021 and 2/13/2021 to 4/13/2021, revealed there were no orders for the treatment to be provided to the patient's wound. F. Interview, with the Administrator on 3/30/2021 at 11:35 AM, confirmed Patient 1's Home Health Certification and Plan of Care for the certification periods of 12/15/2020 to 2/12/2021 and 2/13/2021 to 4/13/2021, did not include physician orders for the treatment of the patient's buttock wound. The Administrator confirmed during the same interview, the orders for the patient's wound care were " ...hanging on the wall in the patient's home ..." G. Review of Patient 1's clinical record revealed the patient was readmitted to the agency on 2/3/2021 following a hospitalization. Review of the patient's Nursing Visit Note dated 2/3/2021 at 4:00 PM revealed the patient returned from the hospital on 2/3/2021 and the patient had a " ...drainage tube in [gender] back..." The clinical record did not contain physician orders for the treatment of the area around the drainage tube and/or the reason for the drainage tube. The patient's plan of care was not revised to address the presence of the drainage tube or cares of the tube by the agency staff. H. Review of Patient 3's Home Health Certification and Plan of Care for the certification period of 12/5/2020 to 2/2/2021 revealed the patient was admitted to the agency on 12/5/2020 with a Stage 4 (Full-thickness skin and tissue loss wound) of the sacral region, hypertension and type 2 diabetes. The plan of care did not include the type of treatment and/ or the frequency of the treatment to be provided. There were no physician orders for the treatment of the patients sacral wound on the plan of care. Review of Patient 3's Home Health Certification and Plan of Care for the certification period of 2/17/2021 to 4/17/2021 revealed the patient's primary diagnosis was a Stage 2 pressure ulcer of sacral region. Review of the plan of care revealed a skilled nurse was to perform wound care. The plan of care did not include the type of treatment or the frequency of the treatment to be provided. I. Review of Patient 5's Home Health Certification and Plans of Care (POC) for the certification period of 12/12/2020 to 2/9/2021 and 2/10/2021 to 4/10/2021 revealed the patient was admitted to the agency with an unstageable sacral pressure ulcer and the skilled nurse was to perform wound care. The plans of care did not include physician orders for the type of treatment or frequency of the treatment to be provided to the sacral pressure ulcer. J. This agency practice provided the opportunity for patients with wounds to not receive the appropriate treatments, at the frequency required and as determined by the physician to prevent further deterioration of their wounds and failed to ensure the physician was actively involved in the treatment of the patient's wounds.

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 review of clinical records, review of policy and procedure and staff interview the agency failed to provide drugs as ordered by the physician for 1 of 7 patients reviewed (Patient 1). Sample size was 7 and census was 101. Findings are: A. Review of the agency policy and procedure titled Medication Administration, no date indicated, revealed when the agency staff are administering medications the staff are to verify the medication is being administered at the correct dose. B. Review of Patient 1's Home Health Certification and Plan of Care for the certification period dated 2/13/2021 to 4/13/2021 revealed a physician's order for the patient to receive Levemir (an injectable medication used for the treatment of insulin dependent diabetes) 100 units per milliliter injection, 20 units injection subcutaneous daily. C. Review of Patient 1's nursing visit note, dated 2/26/2021 revealed the Licensed Practical Nurse (LPN)-L administered 24 units of insulin to the patient. D. There was no documentation in Patient 1's clinical record of a physician order for change of the patient's insulin dosage. E. During interview on 4/1/2021 at 3:45 PM, the agency Administrator and LPN-E confirmed documentation revealed LPN-L administered 24 units of Levemir insulin to Patient 1 on 2/26/2021.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on review of clinical records, review of policy and procedure and staff interviews the agency failed to promptly alert the patient's physician(s) to changes in the patient's condition or needs and/or to inform the physician of the need to alter the plan of care for 7 of 7 patients reviewed (Patients 1, 2, 3, 4, 5, 6, and 7). Sample size was 7 and agency census was 101. Findings are: A. Review of the agency policy and procedure, titled Plan of Care, no date indicated, revealed home care services are to be furnished under the supervision and direction of the patient's physician and is to address the care, treatment and services to be provided. B. Review of the policy and procedure titled Plan of Care Changes, no date indicated, revealed the policy of the agency is to ensure the plan of care is followed and any changes are communicated to all interested parties; and the Director of Nursing (DON) will update the plan of care and the DON will follow procedure to notify all staff of updates to the plan of care. C. Review of Patient 1's Nursing Visit Notes for 12/15/2020 through 3/14/2021 revealed Licensed Practical Nurse (LPN)-L provided wound care for the patient on a daily basis. Review of the Home Health Certification and Plan of Care for the certification periods of 12/15/2020 to 2/12/2021 and 2/13/2021 to 4/13/2021, revealed there were no orders for the provision of wound care by the agency staff. The clinical record did not contain verification, the patient's physician was contacted for wound care orders. D. Interview with the Administrator on 3/30/2021 at 11:35 AM confirmed Patient 1's Home Health Certification and Plan of Care for the certification periods of 12/15/2020 to 2/12/2021 and 2/13/2021 to 4/13/2021, did not include physician orders for the provision of wound cares. The Administrator confirmed during the same interview, the orders for the patient's wound care were " ...hanging on the wall in the patient's home ..." E. Review of Patient 1's clinical record revealed the patient was readmitted to the agency on 2/3/2021 following hospitalization. Review of the patient's Nursing Visit Note dated 2/3/2021 at 4:00 PM revealed the patient returned from the hospital on 2/3/2021 and the patient had a " ...drainage tube in [gender] back ..." There were no physician orders regarding the cares to be provided by the agency staff to the drainage tube in the patient's back. F. The clinical record did not contain verification, Patient 1's physician was notified of the change in the patient's condition and/or needs. G. Review of Patient 2's Home Health Certification and Plan of Care for the certification periods of 10/30/2020 to 12/28/2020, 12/29/2020 to 2/6/2021 and 2/7/2021 to 4/27/2021 revealed the patient was to receive skilled nurse visits 2 times per week for 9 weeks; Physical Therapy (PT) for evaluation/treatment 2-3 visits per week for 9 weeks; Occupational Therapy (OT) for evaluation and treatment 2-3 visits per week for 9 weeks; and Home Health Aide (HHA) services 5 days per week, for 2 hours per visit. Review of Patient 2's clinical record revealed there were no skilled nursing visits, HHA, PT or OT visits provided to the patient the week of 11/1/2020 through 11/7/20202. Review of Patient 2's clinical record revealed visits were conducted by agency staff as follows: 11/8/2020 - 11/14/2020: HHA visits on 11/10/20, 11/11/20, 11/12/220, 11/13/2o and 11/14/2020; There were no PT or OT visits for evaluation or treatment; The week of 11/15/2020 - 11/21/2020: No PT or OT visits for evaluation or treatment; The week of 11/22/2020 - 11/28/2020: HHA 11/24/2020; There were no PT or OT visits; The week of 12/6/2020- 12/12/2020: HHA visits 12/8/2020, 12/9/2020 and 12/10/2020; The week of 12/13/2020 - 12/19/2020: HHA visits 12/14/2020, 12/15/2020, 12/16/2020, and 12/18/2020; The week of 12/20/2020 - 12/26/2020 HHA visits 12/23/2020 and 12/24/2020; The week of 12/27/2020 - 1/2/2021: HHA visits 12/30/2020 and 12/31/2020; OT visit 12/28/2020; The week of 1/3/2021 - 1/9/2021: HHA 1/4/2021, 1/6/2021 and 1/8/2021; The week of 1/10/2021 - 1/16/2021: HHA 1/11/2021 and 1/14/2021; The week of 1/17/2021- 1/23/23021: HHA visits 1/18/2021, 1/21/2021 and 1/22/2021; The week of 1/24/2021 - 1/30/2021: HHA visits 1/27/2021 and 1/28/2021 and 1 OT visit 1/27/2021; The week of 1/31/2021 - 2/6/2021: HHA visits 2/3/2021, and 2/5/2021, no documented OT visits; The week of 2/7/2021 - 2/13/2021: HHA visits 2/8/2021, 2/10/2021 and 2/12/2021 and 1 OT visit 2/8/2021; The week of 2/14/2021 - 2/20/2021: HHA 2/17/2021 and 2/19/2021and 1 PT visit 2/17/2021; The week of 2/21/2021 - 2/27/2021: 3 visits by a HHA 2/22/20212, 2/24/2021 and 2/26/2021, and a skilled nurse visit 2/23/2021; The week of 2/28/2021- 3/6/2021: HHA visits 3/1/2021, 3/3/2021 and 3/5/2021; The week of 3/7/2021 - 3/13/2021: HHA visits 3/8/2021, 3/10/2021, and 3/12/2021; The week of 3/14/2021 - 3/20/2021: HHA visits 3/15/2021 and 3/20/21; and The week of 3/21/2021 - 3/27/2021: HHA visits 3/22/2021, 3/24/2021 and 3/26/2021. H. The clinical record did not contain documentation Patient 2's physician was notified of the need to alter the patient's plan of care. I. Review of Patient 3's Home Health Certification and Plan of Care for the certification period of 2/17/2021 to 4/17/2021 revealed the patient was to receive skilled nursing 7 times per week for 9 weeks and HHA 7 times per week for 9 weeks. Review of Patient 3's clinical record revealed no documentation of HHA visits conducted between 2/17/2021 and 4/1/2021. J. The clinical record did not contain documentation Patient 3's physician was notified of the need to alter the patient's plan of care. K. Review of the Nurse Visit Notes dated 3/19/2021 from 9:30 AM to 11:00 AM by Licensed Practical Nurse- L revealed Patient 3's " ...wounds are healing, looks and smell bad, but wounds are getting smaller." L. The clinical record did not contain documentation the patient's physician was made aware of the odor and appearance of Patient 3's wounds. M. Review of Patient 4's Home Health Certification and Plan of Care for the certification period of 3/8/2021 to 5/6/2021 revealed the patient was to receive the services of a skilled nurse 1 time per week for 9 weeks, PT 4 visits per week for 9 weeks, OT 2 to 3 visits per week for 9 weeks and HHA 3 times per week for 9 weeks. N. Review of Patient 4's clinical record revealed no documentation of skilled nurse visits provided to the patient from the 3/8/2021 admission to 3/31/2021; and there was no documentation PT or OT visits were conducted for the patient. O. The Administrator, during interview on 4/6/2021 at 11: 45 AM confirmed Patient 4 did not receive the services of skilled nursing, PT and OT as ordered by the physician and the patient's physician was not notified of the need to alter the patient's plan of care. P. Review of Patient 5's Home Health Certification and Plan of Care for the certification period of 12/12/2020 to 2/9/2021 and 2/10/2021 to 4/10/2021 revealed the patient was to receive the services of a HHA daily for 9 weeks. Q. Review of Patient 5's clinical record revealed the patient did not receive the services of a HHA on 12/28/2020, 1/2/2021, 1/11/2021 and 1/16/2021. R. The Administrator, during interview on 4/6/2021 at 3:05 PM confirmed Patient 5 did not receive the services of a HHA daily as ordered by the physician and the patient's physician was not notified of the need to alter the patient's plan of care. S. Review of Patient 6's Home Health Certification and Plans of Care for the certification period of 12/17/2020 to 2/15/2021 revealed the patient was to receive the services of a skilled nurse (SN) 3 times per week for 9 weeks, PT 2 to 3 visits per week for 9 weeks, OT 2 to 3 visits per week for 9 weeks and Speech Therapy (ST) 2 to 3 visits per week for 9 weeks and a HHA daily. T. Review of Patient 6's clinical record revealed the patient did not receive the services of ST as ordered by the physician. The patient's clinical record did not contain documentation the patient's physician was notified of the need to alter the patient's plan of care. U. LPN-E during interview on 4/5/2021 at 3:10 PM confirmed ST services were not provided to Patient 6 as ordered by the physician on admission 12/17/2020, and the physician was not notified of the need to alter the patient's plan of care. V. Review of Patient 6's clinical record revealed visits were conducted by agency staff as follows: The week of 12/17/2020 - 12/19/2020: skilled nurse visit 12/17/2020; No PT or OT visits; The week of 12/20/2020 to 12/26/2020: No OT visits were conducted; and The week of 1/17/2021 - 1/23/2021: No PT visits. W. Review of Patient 6's clinical record revealed there was no physician order to alter the patients plan of care for the frequency of the SN, HHA, PT or OT visits to be conducted for the patient. X. Review of Patient 6's Home Health Certification and Plan of Care for the certification period of 2/16/2021 to 4/15/2021 revealed the patient was to receive skilled nurse visits 3 times per week for 9 weeks, PT 2 to 3 visits per week for 9 weeks, OT 2 to 3 visits per week for 9 weeks and daily HHA visits for 9 weeks. Y. Review of Patient 6's clinical record revealed visits were conducted by agency staff as follows: The week of 2/14/2021 - 2/20/2021: SN visit 2/15/2021, OT visit 2/17/2021, and daily HHA visits; The week of 2/21/2021 - 2/27/2021: SN Visit 2/22/2021, OT visit 2/25/2021, daily HHA visits; The week of 2/28/2021 - 3/6/2021: SN Missed visit forms completed for 3/1/2021 and 3/4/2021; The week of 3/7/2021 - 3/13/2021: SN visit 3/9/2021 and 4 HHA visits 3/8/2021, 3/9/2021, 3/11/2021 and 3/12/2021; The week of 3/14/2021 - 3/20/2021: SN visit 3/15/2012 and Missed visit report for HHA 3/15/2021; HHA Visit 3/16/2021, 3/18/2021 and 3/19/2021; The week of 3/21/2021 - 3/27/2021: Missed visit report for SN visit3/22/2021 and 4 HHA visits 3/22/2021, 3/23/2021, 3/25/2021 and 3/26/2021 Z. Review of Patient 6's clinical record revealed no physician order to alter the patient's plan of care for the frequency of visits of the SN, HHA, PT or OT. AA. LPN-E on 4/5/2021 at 3:10 PM during interview confirmed Patient 6's physician was not notified of the need to alter the plan of care for the patient and there was no physician order to change the frequency of the SN, HHA, PT or OT visits. BB. Review of Patient 7's Home Health Certification and Plan of Care for the certification period of 2/18/2021 to 4/18/2021 revealed physician orders for the patient to receive the services of a SN 1 time daily for 9 weeks, and HHA 1 time daily for 9 weeks. CC. Review of Patient 7's clinical record revealed visits were conducted by agency staff as follows: The week of 2/18/2021- 2/20/2021: SN visit on 2/18/2021; The week of 2/21/2021 - 2/27/2021: SN visit 2/22/21 and 2/25/2021; The week of 2/28/2021- 3/6/2021: SN visit 3/1/2021 and 3/5/2021; The week of 3/7/2021 - 3/13/2021: SN visit 3/8/2021 and 3/11/2021; The week of 3/14/2021- 3/20/2021: SN visit 3/15/2021 and 3/19/2021; The week of 3/21/2021 - 3/27/2021: SN visit 3/21/2021, 3/22/2021, 3/23/2021, 3/24/2021, 3/25/2021 and 3/27/2021; The week of 3/28/2021- 4/3/2021: SN visit 3/28/2021, 3/29/2021, 3/30/2021, 3/31/2021, 4/1/2021 and 4/2/2021. DD. Review of Patient 7's clinical record revealed no physician order to alter the patient's plan of care regarding the frequency of the SN visits. EE. The Administrator during interview on 4/7/2021 from 3 to 4:30 PM confirmed Patient 7's physician was not notified of the need to alter the patient's plan of care and there was no physician's order to change the frequency of the SN visits. FF. This practice provided the opportunity for the physician to not be involved in the care of the patients and for the patients to not receive the treatment and care as needed.

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: Deficiencies cited at G642 and G684 G 642 Based on review of policy and procedure, the agency's Quality Assurance and Performance Improvement (QAPI) documentation and staff interview, the agency failed to measure, analyze and track quality indicators to assess the agency's processes, services and quality of care in 2019 and the agency failed to track and implement interventions for the prevention of infections in 2020 and 2021. Agency census was 101. These failed practices provided missed opportunities for the agency to identify areas of concern, to provide opportunities for improvement and to implement interventions for the prevention of infections. G 684 Based on review of policy and procedure, review of the agency's Quality Assurance and Performance Improvement (QAPI) documentation and staff interview, the agency failed to track and implement interventions for the prevention of infections in 2020 and 2021. These failed practices provided missed opportunities for the agency to identify areas of infection control concerns, provide opportunities for improvement and to implement interventions for the prevention of infections. Agency census was 101. These failed practices provided missed opportunities for the agency to identify areas of infection control concerns, provide opportunities for improvement and to implement interventions for the prevention of infections.

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 review of policy and procedure, the agency's Quality Assurance and Performance Improvement (QAPI) documentation and staff interview, the agency failed to measure, analyze and track quality indicators to assess the agency's processes, services and quality of care and the agency failed to track and implement interventions for the prevention of infections in 2020 and 2021. Agency census was 101. These failed practices provided missed opportunities for the agency to identify areas of concern, to provide opportunities for improvement and to implement interventions for the prevention of infections. Findings are: A. Review of agency policy and procedure, titled Quality Assessment and Performance Improvement (QAPI), no date indicated, revealed the agency was to maintain documentary evidence of its QAPI program and be able to demonstrate its operation; the agency was to identify, measure, analyze, and track quality indicators that included patient adverse events and other relevant data to assess processes of care, services and operations. B. Review of the QAPI documentation for 2019 revealed documentation dated 9/20/2019 indicating the agency was monitoring infection control monthly and as needed when new infection control issues were identified. There was no documentation by the QAPI to verify the agency monitored or tracked patient infections, or to verify the agency was monitoring and tracking infection control issues or rates. There was no QAPI documentation the agency implemented interventions for the prevention of the spread of infections in 2020 or 2021. C. Review of the QAPI documentation dated 10/2/2019, 11/21/2019, 12/20/2019, 1/21/2020, and 2/24/2020 revealed the agency was to conduct chart audits for compliance with documentation of services provided. Review of chart audits conducted by the agency dated 4/2019, 8/28/2019, 3/25/2020 and 4/21/2020 revealed no follow up by the QAPI for issues of non-compliance identified during chart audits. Documentation of a QAPI review dated 3/24/2020 revealed the agency chart audits for compliance with provision of services was completed. There were no additional QAPI audits to monitor for compliance with the provisoin of services and there was no documentation to indicate the agency monitored and/or identified areas of non-compliance with regulations through the QAPI process. D. Interview with the Health Information Manager (HIM) on 4/8/2021 at approximately 2:00 PM confirmed there was no additional documentation of QAPI processes conducted by the agency. During the same interview the HIM confirmed the last QAPI meeting was held by the agency on 9/16/2020 and there was no QAPI documentation the agency implemented interventions for the prevention of the spread of infections in 2020 or 2021.

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 review of policy and procedure, review of the agency's Quality Assurance and Performance Improvement (QAPI) documentation and staff interview, the agency failed to track and implement interventions for the prevention of infections in 2020 and 2021. These failed practices provided missed opportunities for the agency to identify areas of infection control concerns, provide opportunities for improvement and to implement interventions for the prevention of infections. Agency census was 101. Findings are: A. Review of the agency's policy and procedure titled Infection Control Plan, no date indicated, revealed the agency management team, including the Director of Clinical Services, Quality Improvement Coordinator have the authority for routine identification and analysis of the incidence and cause of all infections and shall develop and implement a plan for surveillance, prevention and control of infection hazards. Infection control surveillance indicators are to be included in the activities reviewed and the data collected as part of the agency performance improvement plan. B. Review of the QAPI documentation dated 9/20/2019 indicated the agency was monitoring infection control monthly and as needed when new infection control issues were identified. C. There was no documentation the agency's QAPI had a program for surveillance, identification, prevention, control and investigation of infectious and communicable diseases. There was no documentation the agency QAPI conducted surveillance and/or implemented procedures for the prevention and control of the spread of infections in 2020. D. Review of the policy and procedure titled Ambis Home Healthcare, LLC Covid-19 Policy, dated 1/1/2021, addressed the screening of agency staff for signs and symptoms of COVID-19. The policy did not address screening of patients served by the agency and/or interventions for the prevention of the spread of COVID-19. E. There was no documentation the agency's QAPI addressed surveillance, prevention and control of COVID-19. F. The agency Administrator on 4/1/2021 at 10:00 AM confirmed the agency policy for COVID-19 screening of staff was not implemented until 1/1/2021 and the the agency QAPI had not met since 9/16/2020.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Deficiencies cited at G710 and G726 G710 Based on review of clinical records, review of policy and procedure and staff interview the agency failed to have a skilled professional evaluate the plans of care for 7 of 7 patients reviewed (Patient 1, 2, 3, 4, 5, 6, and 7) to ensure services were provided to the patients as ordered by the physician and indicated in the plan of care. This practice resulted in 7 of 7 patients reviewed not receiving the services as ordered by the patient's physician. Sample size was 7 and agency census was 101. G726 Based on review of job descriptions, personnel files and staff interview the agency failed to provide Registered Nurse (RN) supervision of the Licensed Practical Nurses (LPN) employed by the agency, to evaluate performance in providing cares, treatments, patient education, communication with the RN and data collection regarding the patient's status and health needs. The agency employed 2 LPNs at the time of the survey. This failure provided the opportunity for cares provided by LPNs not to be in compliance with agency policy and procedure.

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 review of clinical records, review of policy and procedure and staff interview the agency failed to have a skilled professional evaluate the plans of care for 7 of 7 patients reviewed (Patient 1, 2, 3, 4, 5, 6, and 7) to ensure services were provided to the patients as ordered by the physician and as indicated in the plan of care. This practice resulted in 7 of 7 patients reviewed not receiving the services as ordered by the patient's physician. Sample size was 7 and agency census was 101. Findings are: A. Review of the agency policy and procedure, titled Plan of Care, no date indicated, revealed home care services were to be furnished under the supervision and direction of the patient's physician and the plan of care is to address the care, treatment and services to be provided. B. Review of the policy and procedure titled Plan of Care Changes, no date indicated, revealed the policy of the agency is to ensure the plan of care is followed and any changes are communicated to all interested parties and the Director of Nursing (DON) was to update the plan of care and DON follow procedure to notify all staff regarding updates to the plan of care. C. Review of the clinical records and the plans of care for 7 of the 7 sampled patients reviewed identified services were not provided to the patients as ordered by the physician and as outlined below: 1. Patient 1: Review of Patient 1's Home Health Certification and Plan of Care for certification period of 12/15/2020 to 2/12/2021 and 2/13/2021 to 4/13/2021 revealed: a. The Plan of care did not include physician orders for wound care being provided by the agency; and b. The Plan of care did not include orders for the patient's drainage tube identified on 2/3/2021. 2. Patient 2: Review of Patient 2's Home Health Certification and Plan of Care for certification period of 10/30/2020 to 12/28/2020, 12/29/2020 to 2/6/2021, and 2/7/2021 to 4/27/2021 revealed the patient was to receive the following services: skilled nurse visits 2 times per week for 9 weeks; Physical Therapy (PT) for evaluation/treatment then 2-3 visits per week for 9 weeks; Occupational Therapy (OT) for evaluation and treatment then 2-3 visits per week for 9 weeks; and Home Health Aide (HHA) services 5 days per week, for 2 hours per visit. a. Home Health Aide (HHA) services were not provided as ordered by the physician and outlined in the plan of care; b. Physical Therapy (PT) services were not provided as ordered by the physician and outlined in the plan of care; and c. Occupational Therapy (OT) services were not provided as ordered by the physician and as outlined in the plan of care. 3. Patient 3: Review of Patient 3's Home Health Certification and Plan of Care for certification period of 2/17/2021 to 4/17/2021: revealed the patient was to receive skilled nursing 7 visits per week for 9 weeks and HHA visits 7 visits per week for 9 weeks. a. HHA services were not provided as ordered by the physician and as outlined in the plan of care. 4. Patient 4: Review of Patient 4's Home Health Certification and Plan of Care for certification period of 3/8/2021 to 5/6/2021 revealed the patient was to receive the services of a skilled nurse 1 time per week for 9 weeks, PT 4 times per week for 9 weeks, OT 2 to 3 times per week for 9 weeks and HHA 3 times per week for 9 weeks. a. Skilled nurse (SN) services were not provided as ordered by the physician and as outlined in the plan of care; b. PT services were not provided as ordered by the physician and as outlined in the plan of care; and OT services were not provided as ordered by the physician and as outlined in the plan of care. 5. Patient 5: Review of Patient 5's Home Health Certification and Plan of Care for certification period of 12/12/2020 to 2/9/2021 and 2/10/2021 to 4/10/2021, revealed the patient was to receive the services of a HHA daily for 9 weeks. a. HHA services were not provided as ordered by the physician and as outlined in the plan of care. 6. Patient 6: Review of Patient 6's Home Health Certification and Plans of Care for the certification period of 12/17/2020 to 2/15/2021 revealed the patient was to receive the services of a skilled nurse (SN) 3 times per week for 9 weeks, PT 2 to 3 visits per week for 9 weeks, OT 2 to 3 visits per week for 9 weeks and Speech Therapy (ST) 2 to 3 visits per week for 9 weeks and a HHA daily. a. ST services were not provided as ordered by the physician and as outlined in the plan of care; b. PT services were not provided as ordered by the physician and as outlined in the plan of care; c. OT services were not provided as ordered by the physician and as outlined in the plan of care; and d. SN visits were not provided as ordered by the physician and as outlined in the plan of care. Review of Patient 6's Home Health Certification and Plans of Care for the certification period of 2/16/2021 to 4/15/2021 revealed the patient was to receive the services of skilled nurse 3 times per week for 9 weeks, PT 2 to 3 visits per week for 9 weeks, OT 2 to 3 visits per week for 9 weeks and HHA daily for 9 weeks. a. PT services were not provided as ordered by the physician and as outlined in the plan of care; b. SN services were not provided as ordered by the physician and as outlined in the plan of care; c. HHA services were not provided as ordered by the physician and as outlined in the plan of care; and d. OT services were not provided as ordered by the physician and as outlined in the plan of care. 7. Patient 7: Review of Patient 7's Home Health Certification and Plan of Care for the certification period of 2/18/2021 to 4/18/2021 revealed physician orders for the patient to receive the services of a SN 1 time daily for 9 weeks, and HHA 1 time daily for 9 weeks. a. SN services were not provided as ordered by the physician and as outlined in the plan of care. D. There was no documentation in the clinical records of Patients 1, 2, 3, 4 ,5, 6, or 7 to confirm the patient's plans of care were reviewed by the Director of Nursing for accuracy and compliance and to ensure the plan of care was followed. E. Interview with the Administrator on 4/7/2021 from 3:00 PM to 4:30 PM confirmed the agency failed to review the plans of care to ensure services were provided as ordered by the physician and indicated in the plan of care.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on review of job descriptions, personnel files and staff interview the agency failed to provide supervision of the Licensed Practical Nurses (LPNs) employed by the agency by a Registered Nurse (RN) to evaluate performance in providing cares, treatments, patient education, communication with the RN and data collection regarding the patient's status and health needs. The agency employed 2 LPNs at the time of the survey. This failure provided the opportunity for cares provided by LPNs not to be in compliance with agency policy and procedure.. Findings are: A. Review of the LPN job description, no date indicated, revealed the LPN provides skilled nursing visits for patients and follows the patient care plan established by the RN. B. Review of LPN-L's personnel file revealed no documentation of supervisory visits by a RN. C. The Administrator on 3/30/2021 at 12:40 PM during interview, confirmed the agency was unaware of the requirement for the provision of supervision of LPNs and the Administrator confirmed the agency had not provided supervision of the 2 LPNs employed by the agency.

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: Deficiencies cited at G754 and G768 G754 Based on review of policy and procedure, review of personnel files and staff interview the agency failed to ensure Staff member-M had met the requirements for a nurse aide training and competency evaluation program approved by the State of Nebraska and was currently in good standing with the state nurse aide registry prior to be permitted to provide services to patients of the agency. The agency employed 17 Home Health Aides (HHA). Agency census was 101. G768 Based on review of policy and procedure, review of personnel files and staff interview, the agency failed to complete a written competency evaluation for 1 of 8 Home Health Aides reviewed (HHA)-I and failed to conduct a skills competency evaluation for 7 of 8 HHAs personnel records reviewed (HHA-I, J, K, A, F, G, and M). The agency employed 17 HHAs. Agency census was 101.

A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This ELEMENT is not met as evidenced by: Based on review of policy and procedure, review of personnel files and staff interview the agency failed to ensure staff member-M had met the requirements for a nurse aide training and competency evaluation program approved by the State of Nebraska and was currently in good standing with the state nurse aide registry prior to be permitted to provide services to patients of the agency. The agency employed 17 Home Health Aides (HHA). Agency census was 101. Findings are: A. Review of the policy titled, Reference Checks, no date indicated, revealed the agency was to verify and validate background factors for applicants for employment including verification of licensure and/or registration. B. Review of staff member-M's personnel file revealed a 12/21/2020 date of hire. There was no documentation in the personnel file to verify the agency had validated the staff member was listed on the state nurse aide registry. C. The Administrator during interview on 3/30/2021 at 1:50 PM confirmed staff member-M was not on the state nurse aide registry. D. Interview with the Home Health Aide Manager on 4/8/2021 at approximately 3:00 PM confirmed staff member-M began providing cares to agency patients on 12/30/2020.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on review of policy and procedure, review of personnel files and staff interview, the agency failed to complete a written competency evaluation for 1 of 8 Home Health Aides (HHA) reviewed HHA-I and failed to conduct a skills competency evaluation for 7 of 8 HHA personnel records reviewed (HHA-I, J, K, A, F, G, and M). The agency employed 17 HHAs. Agency census was 101. Findings are: A. Review of the agency policy and procedure, titled Competency Evaluation of Home Care Staff, no date indicated, revealed skills tests including written tests and direct observation of skill were to be completed as determined by the by the agency policies; HHA competency is evaluated by observing the aide with a client or "pseudo" client; and a HHA will not be permitted to provide HHA services until evidence of adequate training and/or competency has been determined by the designated professional in the agency and documentation of individual HHA training and/or competency was to be maintained in the HHA's personnel file. B. Review of the agency policy and procedure, titled Employment, no date indicated written skills tests and competency testing was to be administered to all HHAs. C. Review of HHA-I's personnel record revealed a date of hire of 11/25/2020. There was no documentation in the personnel file of a written or skills competency evaluation being completed. D. Review of HHA-J's personnel record revealed a date of hire of 10/28/2020. There was no documentation in the personnel file of a skills competency evaluation being completed. E. Review of HHA-K's personnel record revealed a date of hire of 12/9/2020. There was no documentation in the personnel file of a skills competency evaluation being completed. F. Review of HHA-A's personnel record revealed a date of hire of 3/9/2020. There was no documentation in the personnel file of a skills competency evaluation being completed. G. Review of HHA-F's personnel record revealed a date of hire of 3/19/2020. There was no documentation in the personnel file of a skills competency evaluation being completed. H. Review of HHA-G's personnel record revealed a date of hire of 5/5/2020. There was no documentation in the personnel file of a skills competency evaluation being completed. I. Review of HHA-M's personnel record revealed a date of hire of 12/21/2020. There was no documentation in the personnel file of a skills competency evaluation being completed. J. Interview with the agency Administrator on 4/6/2021 at 8:50 AM confirmed there was no documentation of a written competency evaluation in the personnel file for HHA-I, and there was no documentation of a skills competency evaluation in the personnel files for HHAs I, J, K, A, F, G, or 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: Deficiencies cited at G948, G968 and G982 G948 Based on review of clinical records, personnel files, the agency's Position (job) Description for the Home Health Administrator, policies and procedures and staff interviews the agency Administrator failed to organize and direct the day-to-day functions of the agency to ensure compliance with state and federal regulations for home health agencies as required in the agency's Home Health Administrator job description. The agency employed 29 staff and the agency contracted with 2 Registered Nurses (RN-C and O) for the provision of patient cares. Agency census was 101. This deficient practice had the potential to adversely affect all 101 patients who were provided care and treatment by the employed and contracted staff of the agency. G968 Based on review of clinical records, the agency Position (Job) description for the Clinical Supervisor, policies and procedures and staff interviews the Clinical Supervisor failed to assure patient plans of care were individualized, updated and implemented for 7 of 7 patients reviewed. Sample size was 7 and agency census was 101. This deficient practice had the potential to adversely affect all 101 patients who were provided care and treatments by the agency staff. G982 Based on review of clinical records and personnel files, review of policy and procedures and staff interview the agency failed to ensure an employee of the agency provided at least one service to 22 of the 101 patients. Agency census was 101.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on review of clinical records, personnel files, the agency's Position (job) Description for the Home Health Administrator, policies and procedures and staff interviews the agency Administrator failed to organize and direct the day-to-day functions of the agency to ensure compliance with state and federal regulations for home health agencies as required in the agency's Home Health Administrator job description. The agency employed 29 staff and the agency contracted with 2 Registered Nurses (RN-C and O) for the provision of patient cares. Agency census was 101. This deficient practice had the potential to adversely affect all 101 patients who were provided care and treatment by the employed and contracted staff of the agency. Findings are: A. Review of the Position (Job) description for the Home Health Administrator revealed the Administrator's responsibilities included: 1. Plans, develops and directs the programs, services activities and employees of the agency. 2. Plans, organizes and directs the agency's ongoing functions. 3. Assures compliance with federal/state regulations governing home health care services. 4. Provides leadership in developing and maintaining data collection, recording and reporting systems to ensure proper service, uniform accounting, data collection, and measurement of outcomes. 5. Provides direction in formulating the programs and policies. B. Review of agency clinical records revealed deficient practices at: 1. G 510 - Condition level 2. G 528 3. G 570- Condition level 4. G 572 5. G 576 6. G 580 7. G 590 8. G 1008- Condition level 9. G 1022 C. Review of agency personnel files revealed deficiencies at: 1. G 700 - Condition level 2. G 710 3. G 726 4. G 750 -Condition level 5. G 754 6. G 768 D. Review of agency policies and procedures revealed deficient practices at: 1. G 640- Condition level 2. G 642 3. G 684 4. G 940-Condition level 5. G 948 6. G 968 7. G 982 8. E 001- Condition level 9. E 004 10. E 006 11. E 033 12. E 037

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 review of clinical records, the agency Position (Job) description for the Clinical Supervisor, policies and procedures and staff interviews the Clinical Supervisor failed to assure patient plans of care were individualized, updated and implemented for 7 of 7 patients reviewed. Sample size was 7 and agency census was 101. This deficient practice had the potential to adversely affect all 101 patients who were provided care and treatments by the agency staff. Findings are: A. Review of the Position (Job) description for the Clinical Supervisor revealed the job responsibilities included: 1. Manages, supervises, coordinates, evaluates and develops client care teams to ensure quality care delivery and appropriate case management within the agency scope of services and policies; state, federal and local laws and Nurse Practice Act. 2. Manages and directs a team of Nurse Case Managers ensuring safe, effective and appropriate home care services. 3. Provides direction to teams to assure client needs are met and services are provided according to the plan. 4. Educates agency staff on clinical services, policies and procedures as needed. 5. Ensures accuracy, completeness, and timeliness of clinical documentation in accordance With agency policies and procedures, regulatory requirements and industry standards. 6. Assists quality improvement teams with data collection for the Quality Improvement Plan established by the agency. 7. Reviews OASIS data collection to assure accuracy and consistency with requirements. 8. Provides on-site supervision per agency policy and as needed to determine staff competency and respond to educational and developmental needs. B. Review of agency clinical records revealed deficient practice at: 1. G 528 2. G 572 3. G 576 4. G 580 5. G 590 6. G 710 C. Review of agency personnel files revealed deficient practice at: 2. G 726 3. G 754 4. G 768 D. Review of agency policies and procedures revealed deficient practice at: 1. G 642 2. G 684 3. G 982 4. G 1022 E. The agency Administrator, during interview on 4/8/2021 from 3:00 PM to 4:30 PM, confirmed deficient practices identified involved the job responsibilities of the agency Clinical Supervisor as identified in the job description. The Administrator confirmed the job titles and job descriptions for Clinical Supervisor and Director of Nursing were for the same staff member.

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 review of clinical records and personnel files, review of policy and procedures and staff interview the agency failed to ensure an employee of the agency provided at least one service to 22 of the 101 patients. Agency census was 101. Findings are: A. Review of the policy and procedure titled Contract Employees, no date indicated, revealed contract personnel are employees of organizations who contract with the agency, or individuals who contract directly with the agency on an hourly, per visit, or other basis to provide services to clients per a written agreement. Contract personnel or organizations shall execute a written agreement, including charges, with the agency outlining the rules governing professional services rendered by contracted personnel and a copy of the contract was to remain in the agency's administrative files. B. The administrator, during interview on 4/8/2021 between 3:30 PM and 5:00 PM confirmed Registered Nurses (RN)-C and O were not employees of the agency, and both RNs were under contract to provide services to the patients of the agency. The Administrator during the same interview confirmed the agency's by-laws did not address the provision of cares to patients by contracted staff. C. Review of the personnel files for RN-C and O revealed no documentation of a contract between the agency and the RNs. D. Interview with RN-C on 4/8/2021 at approximately 12:30 PM confirmed the RN was under contract with the agency to provide skilled nursing services for the agency. E. Interview with RN-O on 4/8/20221 at approximately 3:00 PM confirmed the RN was under contract with the agency to provide skilled nursing services for the agency. F. Interview with the Administrator 4/8/2021 from 3:00 PM to 5:00 PM confirmed the personnel files of RN-C and RN-O did not contain documentation of a contract between the agency and either of the RNs. G. Interview with the Administrator and LPN-E on 4/8/2021 from 3:00 to 5:00 PM confirmed 10 patients (Patient 5, 7, 8, 9, 10, 11, 12, 13, 14, and 15) received only the services of RN-C, a RN under contract with the agency to provide skilled nursing services and 12 patients (Patients 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, and 27) received only the services of RN-O, a RN under contract with the agency to provide skilled nursing service.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on review of clinical records, review of agency policies and procedures and staff interviews the agency failed to assure the clinical records for 7 of 7 patients reviewed contained current information for each patient. The agency failed to ensure the information included in the clinical records was accurate and included physician orders for the provision of care and the physician orders for cares for each patient were followed. This condition is not met as evidenced by deficiencies cited at G572, G576, G580 and G1022. G572 Based on review of clinical records, review of policy and procedure and staff interview the agency failed to provide services to 7 of 7 patients ( Patients 1, 2, 3, 4, 5, 6, and 7) as written in the individualized plan of care and as outlined in physician orders. The agency failed to notify the physician caring for the patient of the need to alter the plan of care. Sample size was 7 and agency census was 101. This practice failed to allow the physician to be aware of and make potential changes to the services provided to the patients. G576 Based on review of clinical records, review of policy and procedure and staff interview the agency failed to record the physician orders for wound care on the plan of care for 3 of 3 patients reviewed with wounds (Patient 1, 3, and 5). Sample size was 7 and agency census was 101. G580 Based on review of clinical records, review of policy and procedure and staff interview the agency failed to provide drugs as ordered by the physician for 1 of 7 patients reviewed (Patient 1). Sample size was 7 and census was 101. G1022 Based on review of clinical records and staff interview the agency failed to complete and provide a transfer summary to the receiving health care facility when 2 of 7 patients (Patient 1 and 7) were transferred from the agency to another health care facility. Sample size was 7 and agency census was 101. This practice provided the opportunity for the lack of continuity of care for the patients.

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 review of clinical records and staff interview the agency failed to complete and provide a transfer summary to the receiving health care facility when 2 of 7 patients (Patient 1 and 7) were transferred from the agency to another health care facility. Sample size was 7 and agency census was 101. This practice provided the opportunity for the lack of continuity of care for the patients. Findings are: A. Review of the clinical record for Patient 1 revealed the patient was transferred to another health care facility on 1/31/2021 and on 2/8/2021. There was no documentation the agency provided a transfer summary to the receiving health care facilities. B. Interview with Licensed Practical Nurse(LPN)-E on 3/30/2021 at 12:05 PM confirmed there was no documentation in Patient 1's clinical record of transfer summary information being provided to the receiving health care facilities following the patient's transfer on 1/3/12021 and/or 2/8/2021. C. Review of Patient 1's clinical record revealed the patient was discharged from the agency to another agency on 3/15/2021. There was no documentation in the patients' clinical record of a transfer summary being provided to the receiving health care facility. D. Interview with LPN-E on 4/7/2021 at 12:30 PM confirmed a transfer summary was not provided to the health care facility who had assumed the care of Patient 1's following discharge from agency on 3/15/2021. E. Review of Patient 7's clinical record revealed the patient was transferred to the hospital on 3/17/2021 and 3/19/2021. There was no documentation a transfer summary was provided to the receiving health care facility following the 3/17/2021 or the 3/19/2021 transfers. F. Interview with Registered Nurse C on 4/5/2021 at 10:45 AM confirmed transfer summaries were not provided to the receiving health care facilities following the patient transfers on 3/17/2021 and /or 3/19/2021.