Every finding on record at L. Woerner, Inc., D/B/A Hcr

The following Statement of Deficiencies is the result of an onsite complaint investigation survey of complaints 111495 and 113631 conducted 03/05/2025 through 03/10/2025. The survey consisted of a review of three (3) patient records. The active patient census on 03/05/2025 was 961. Interviews were conducted with the Chief Nursing Officer, Administrator, Director of Patient Services, President, Director of Compliance and additional clinical staff. Complaints 111495 and 113631 are substantiated. From 10/21/2024 to 11/05/2024 a recertification survey of the agency was conducted. During the recertification survey deficiencies were cited. In response to the identified deficiencies, the agency submitted an acceptable plan of correction with implementation date of full compliance as 12/30/2024. As a result, any deficient practices that were identified in the review of the patient records for this survey that were cited in the recertification survey, will not be recited for the timeframe the agency was implementing its corrective actions. The following deficiencies have been identified as a result of the survey: G- 0544, G- 0546, G- 0580, G- 0588, G- 0592, G- 0984, and G- 1030.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on clinical record reviews and staff interview for three (3) of three (3) patients (Patient #’s 1, 2, and 3), the agency failed to ensure the comprehensive assessment was updated and revised to reflect changes in the patient's health status. Failure to ensure comprehensive assessments are updated and revised, has the potential for negative patient outcomes. The agency failed to ensure comprehensive assessments are updated and revised as evidenced by the following: Patient #1 – This 80-year-old patient with diagnoses that include varicose veins of left lower extremity with ulcer, non-pressure chronic ulcer to other part of left lower leg and hypertensive chronic kidney disease was admitted to the home health agency on 07/17/2024 and discharged on 01/24/2025. Review of the Home Health Certification and Plan of Care from 09/15/2024 to 11/13/2024 revealed orders for wound care to left mid calf until healed: cleanse wound with soap and water or wound cleanser, apply hydrofera blue as the primary dressing, apply abd (abdominal) pad and tubigrip as the secondary dressing, tubigrips bilaterally, change three times weekly and as needed for strikethrough drainage or dressing dislodgement using clean technique. Review of the Registered Nurse Wound Care Revisit Note dated 09/16/2024 revealed the Registered Nurse documented performing a wound assessment to the left mid calf non pressure ulcer and wound care was completed per orders. The assessment fails to specify the wound care treatment that was provided to the patient. During interview on 03/06/2025 at 03:24 PM, the Interim Clinical Operations Manager stated the Registered Nurse that performed the identified assessment no longer works for the agency. The Interim Clinical Operations Manager stated the Registered Nurse failed to associate the wound care ordered from the plan of care to her individual assessment. Patient #2 – This 69-year-old patient with diagnoses that include unstageable pressure ulcer of right hip, encephalopathy and benign neoplasm of brain was admitted to the home health agency on 05/13/2024 and discharged on 07/30/2024. Review of the undated agency policy and procedure entitled “Wound Care Standards of Practice” revealed “A pressure ulcer/injury can be restaged…Periodically review the stage to ensure it is accurate.” Review of the Registered Nurse Wound Care Revisit Note dated 06/04/2024 revealed the Registered Nurse documented the eschar that was covering the right greater trochanter unstageable pressure ulcer has come off the wound bed. Review of the clinical record lacks documentation the Registered Nurse assessed and restaged the pressure ulcer upon the eschar being removed from the wound bed. During interview on 03/06/2025 at 04:47 PM, the Director of Patient Services stated the Registered Nurse no longer works for the agency and the clinician failed to restage the wound once the eschar was removed and the wound bed was able to be visualized. Patient #3 – This 87-year-old patient with diagnoses that include pressure ulcer of left buttock, stage 2, type 2 diabetes mellitus without complications and chronic pain was admitted to the home health agency on 02/01/2025. Review of the Home Health Certification and Plan of Care from 02/01/2025 to 04/01/2025 revealed orders for the licensed professional to report a fasting blood sugar of less than seventy (70) or greater than three hundred (300) to the authorized provider. Review of the Registered Nurse Wound Care Revisit Note dated 02/04/2024 lacks documentation of a fasting blood sugar being obtained or recorded. During interview on 03:16 PM, the Registered Nurse stated it was an oversight that the patient’s fasting blood sugar result was not documented.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with agency staff for two (2) of three (3) patients (Patient #’s 1 and 2) requiring a recertification assessment, the agency failed to ensure a comprehensive assessment was completed within the last five (5) days of the sixty (60) day certification period. Failure to update the comprehensive assessment in a timely manner has the potential for unmet patient needs. The agency failed to ensure a comprehensive assessment was completed within the last five (5) days of the sixty (60) day certification period as evidenced by the following: Patient #1 – This 80-year-old patient with diagnoses that include varicose veins of left lower extremity with ulcer, non-pressure chronic ulcer to other part of left lower leg and hypertensive chronic kidney disease was admitted to the home health agency on 07/17/2024 and discharged on 01/24/2025. Review of the Home Health Certification and Plan of Care revealed the certification period is from 01/13/2025 to 03/13/2025. Review of the Registered Nurse Recert With Skill Visit Note dated 01/15/2025 revealed the comprehensive assessment for the recertification was completed on 01/15/2025, which is not within the last five (5) days of the prior certification period. During interview on 03/06/2025 at 03:55 PM, the Director of Patient Services stated there was insufficient staffing to conduct the comprehensive assessment within the required time frame. Patient #2 – This 69-year-old patient with diagnoses that include unstageable pressure ulcer of right hip, encephalopathy and benign neoplasm of brain was admitted to the home health agency on 05/13/2024 and discharged on 07/30/2024. Review of the Home Health Certification and Plan of Care revealed the certification period is from 07/12/2024 to 09/09/2024. Review of the clinical record lacks documented evidence an assessment was completed by the Registered Nurse from 07/03/2024 through 07/21/2024. Review of the Registered Nurse Recert With Skill Visit Note dated 07/22/2024 revealed the comprehensive assessment for the recertification was completed on 07/22/2024, which is not within the last five (5) days of the prior certification period. During interview on 03/07/2024 at 09:32 AM, the Chief Nursing Officer, Administrator stated the Registered Nurse that was assigned to the patient no longer works for the agency. The Chief Nursing Officer stated the agency conducted their own investigation and determined there is no documentation of the care the patient received by the former Registered Nurse on 06/20/2024, 06/27/2024, and 07/02/2024 and there is no documentation of any nursing visits being made from 07/03/2024 through 07/21/2024. During interview on 03/07/2025 at 09:43 AM, the Chief Nursing Officer, Administrator stated the agency planned to make a visit on 07/09/2024 but the patient’s sister refused to allow the visit to occur.

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 and interviews with agency staff, for one (1) of three (3) patients (Patient #1), the agency failed to ensure services and treatments are administered in accordance with physician orders. Failure to ensure services and treatments are provided in accordance with physician’s orders has the potential to result in poor quality of care. The agency failed to ensure services and treatments were provided as ordered as evidenced by the following: Patient #1 – This 80-year-old patient with diagnoses that include varicose veins of left lower extremity with ulcer, non-pressure chronic ulcer to other part of left lower leg and hypertensive chronic kidney disease was admitted to the home health agency on 07/17/2024 and discharged on 01/24/2025. A.) Review of the Verbal Order dated 12/30/2024 revealed a new order for wound care to the left lower extremity to include cleansing with soap and water, pat dry, apply hydrofera blue to surface of wound, cover with optilock and two (2) layer compression wrap. Rest of leg to be covered with calmoseptine. Right leg to be washed with soap and water, rinsed, pat dry, apply calmoseptine and tubigrip. Review of the Skilled Nurse Wound Care Revisit Notes dated 01/01/2025, 01/03/2025, 01/06/2025, 01/08/2025, and 01/12/2025 revealed the Licensed Practical Nurse documented performing left posterior lower leg wound care during the visit to include cleansing with soap and water, applying hydrofera blue as the primary dressing, applying abdominal (ABD) pad and tubigrip as secondary dressing. Bilateral lower extremities skin cleansed with soap and water, dried and calmoseptine applied followed by tubigrips to both lower extremities. The wound care provided does not match the physician's orders. During interview on 03/06/2025 at 03:40 PM, the Interim Clinical Operations Manager stated the Licensed Practical Nurse was unavailable for interview. The Interim Clinical Operations Manager stated the Licensed Practical Nurse failed to associate the updated wound care orders to the identified visits documentation thus documenting on the incorrect wound care. B.) Review of the Home Health Certification and Plan of Care from 11/14/2024 to 01/12/2025 revealed orders for Skilled Nurse one (1) time weekly for one (1) week, three (3) times weekly for four (4) weeks, two (2) times weekly for one (1) week, and three times weekly for three (3) weeks. Review of the clinical record for the week of 01/05/2025 to 01/11/2025 revealed the patient was provided Skilled Nursing services on 01/06/2025 and 01/08/2025. The agency failed to ensure there were three (3) Skilled Nursing Visits, as ordered, during the week of 01/05/2025 to 01/11/2025. Review of the clinical record lacks documentation that the patient refused a visit during identified week. During interview on 03/06/2025 at 03:46 PM, the Director of Patient Services stated that the Licensed Practical Nurse that provided the patient's care was unable to be interviewed. The Director of Patient Services stated the record lacks documentation of why the Skilled Nurse did not provide three (3) visits for the week.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on clinical record review, agency policy and procedure and staff interviews, the agency failed to ensure for two (2) of two (2) recertified patients (Patient #'s 1 and 2) that staff are reviewing and revising the individualized plan of care at least every sixty (60) days. Failure to review and revise the plan of care at lease every sixty (60) days has the potential to result in unmet patient needs and places patients at risk for receiving incorrect and/or inappropriate care. The agency failed to ensure staff are reviewing and revising the individualized plan of care at least every sixty (60) days as evidenced by the following: Review of agency policy and procedure entitled “Care Planning” revised 01/2018 revealed “the total plan of care is reviewed by the attending physician and personnel as often as the severity of the patient’s condition requires, but at least once every sixty (60) days.” Patient #1 – This 80-year-old patient with diagnoses that include varicose veins of left lower extremity with ulcer, non-pressure chronic ulcer to other part of left lower leg and hypertensive chronic kidney disease was admitted to the home health agency on 07/17/2024 and discharged on 01/24/2025. Review of the Home Health Certification and Plan of Care (plan of care) revealed a plan of care was in effect for certification period 11/13/2024 to 01/12/2025. The subsequent certification period was to begin on 01/13/2025 and remain in effect until 03/13/2025. Review of the plan of care for certification period 01/13/2025 to 03/13/2025 revealed the plan of care is dated 01/15/2025, two days after the certification began. The plan of care was not reviewed and revised within the 60-day timeframe. Review of the Registered Nurse Recert With Skill dated 01/15/2025 revealed the Registered Nurse completed the comprehensive assessment to develop the 01/13/2025 to 03/13/2025 plan of care on 01/15/2025. During interview on 03/06/2025 at 03:56 PM, the Interim Clinical Operations Manager stated the orders on the identified plan of care were generated from the 01/15/2025 comprehensive assessment visit. Patient #2 – This 69-year-old patient with diagnoses that include unstageable pressure ulcer of right hip, encephalopathy and benign neoplasm of brain was admitted to the home health agency on 05/13/2024 and discharged on 07/30/2024. Review of the Home Health Certification and Plan of Care revealed a plan of care was in effect from 05/13/2024 to 07/11/2024. The subsequent certification period was to begin on 07/12/2024 and end on 09/09/2024. Review of the plan of care for certification period 07/12/2024 to 09/09/2024 revealed the plan of care is dated 07/22/2024. The plan of care was not reviewed and revised within the 60-day timeframe. Review of the Registered Nurse Recert With Skill Visit Note dated 07/22/2024 revealed the Registered Nurse completed the comprehensive assessment to develop the 07/12/2024 to 09/09/2024 plan of care on 07/22/2024. During interview on 03/07/2024 at 09:32 AM, the Chief Nursing Officer, Administrator stated the Registered Nurse that was assigned to the patient no longer works for the agency. The Chief Nursing Officer stated the agency conducted their own investigation and determined there is no documentation of the care the patient received by the former Registered Nurse on 06/20/2024, 06/27/2024, and 07/02/2024 and there is no documentation of any nursing visits being made from 07/03/2024 through 07/21/2024. During interview on 03/07/2025 at 09:44 AM, the Interim Clinical Operations Manager stated the orders on the identified plan of care were generated from the comprehensive assessment performed on 07/22/2024.

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on clinical record reviews and staff interview for two (2) of three (3) patients (Patient #’s 1 and 2), the agency failed to ensure revised plans of care reflect the patient's needs. Failure to ensure revised plans of care reflect the patient's needs has the potential to result in negative patient outcomes. The agency failed to ensure revised plans of care reflect the patient’s needs as evidenced by the following: Patient #1 – This 80-year-old patient with diagnoses that include varicose veins of left lower extremity with ulcer, non-pressure chronic ulcer to other part of left lower leg and hypertensive chronic kidney disease was admitted to the home health agency on 07/17/2024 and discharged on 01/24/2025. Review of the Verbal Order dated 12/30/2024 revealed the order for “Nurse to perform wound care to left lower extremity by cleansing with soap and water, pat dry, apply hydrofera blue to surface of wound, cover with optilock and 2 (two) layer compression wrap. Rest of leg to be covered with calmoseptine. Right leg to be washed with soap and water, rinsed, pat dry, apply ABD (abdominal pad) to open area, apply calmoseptine and tubigrip. ABI’s (ankle brachial index) have been done.” The order does not state how frequently wound care is to be provided. During interview on 03/06/2025 at 03:30 PM, the Clinical Manager that wrote the Verbal Order stated that the wound care was to be performed three (3) times weekly and the wound care frequency was left off in error. Patient #2 – This 69-year-old patient with diagnoses that include unstageable pressure ulcer of right hip, encephalopathy and benign neoplasm of brain was admitted to the home health agency on 05/13/2024 and discharged on 07/30/2024. A.) Review of the Physician Order dated 06/20/2024 revealed an order for cephalexin 500 milligram capsule, one (1) capsule every six (6) hours by oral route. The order lacks the duration the antibiotic is to be administered. During interview on 03/07/2025 at 09:21 AM, the Chief Nursing Officer, Administrator stated the Registered Nurse who wrote the order is no longer employed by the agency. The Chief Nursing Officer, Administrator stated the order does not to include the end date or how long the antibiotic is to be administered. B.) Review of the Physician Order dated 06/11/2024 revealed an order for wound care to unstageable right hip pressure ulcer- cleanse wound with soap and water or wound cleanser, pack with aquacel AG and cover with foam dressing three (3) times weekly, once a week by Skilled Nurse and twice a week and as needed for strikethrough drainage by caregiver. Review of the Interdisciplinary Coordination Note dated 07/03/2024, revealed a wound consult was completed based on previous wound photos/measurements obtained. The following recommendations were made: obtain a wound culture swab of viable tissue if possible, in-home imaging, switch the current treatment from aquacel to hydrofera blue rope with allevyn life foam dressing changes. Review of the clinical record lacks documented evidence the Skilled Nurse followed up with the recommendations or notified the physician about the recommendations of the wound consultant so that the plan of care could be updated to reflect the patient's needs. Review of the clinical record lacks documented evidence of Skilled Nursing visit documentation from 06/21/2024 through 07/21/2024. Review of the Home Health Certification and Plan of Care from 07/12/2024 to 09/09/2024 revealed an order dated 07/22/2024 for wound to the right greater trochanter wound as follows: cleanse wound with soap and water, apply Santyl as the primary dressing, apply foam dressing as the secondary dressing. Change one (1) time daily and as needed for strikethrough drainage or dressing dislodgement using clean technique (this is the initial wound care order when the patient was initially admitted to services and the patient's wound was unstageable and covered in eschar.) The 07/22/2024 wound care order does not reflect the patient's wound care needs at the time the plan of care was updated. During interview on 03/07/2024 at 09:32 AM, the Chief Nursing Officer, Administrator stated the Registered Nurse that was assigned to the patient no longer works for the agency. The Chief Nursing Officer stated the agency conducted their own investigation and determined there is no documentation of the care the patient received by the former Registered Nurse on 06/20/2024, 06/27/2024, and 07/02/2024 and there is no documentation of any nursing visits being made from 07/03/2024 through 07/21/2024. During interview on 03/07/2024 at 09:50 AM, the Interim Clinical Operations Manager stated the Registered Nurse that conducted the recertification assessment and updated the plan of care on 07/22/2024 for the period of 07/12/2024 to 09/09/2024 failed to associate the most current wound care orders into the updated plan of care.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and staff interview for one (1) of three (3) patients (Patient #1), the agency failed to follow current clinical practice guidelines and agency policy and procedure. Failure to follow agency policies and procedures and ensure compliance with accepted professional standards has the potential to result in unmet patient needs and inadequate care. The agency failed to ensure policies and procedures are followed as evidenced by the following: Review of the undated agency policy and procedure entitled “Wound Care Standards of Practice” revealed “Wounds should be measured a minimum of once per week or if there is a significant change in wound status.” Patient #1 – This 80-year-old patient with diagnoses that include varicose veins of left lower extremity with ulcer, non-pressure chronic ulcer to other part of left lower leg and hypertensive chronic kidney disease was admitted to the home health agency on 07/17/2024 and discharged on 01/24/2025. Review of the clinical record revealed the patient received Skilled Nurse visits for the week of 09/15/2024 to 09/21/2024 on: 09/16/2024, 09/18/2024 and 09/20/2024. Review of the Registered Nurse Wound Care Revisit Notes dated 09/16/2024, 09/18/2024 and 09/20/2024 lack documented evidence of wound measurements being obtained. During interview on 03/06/2025 at 03:28 PM, the Director of Patient Services stated the Registered Nurse that conducted the identified visits no longer works for the agency. The Director of Patient Services acknowledged the wound was not measured during the identified week and stated there is no documentation of an explanation of why the wound was not measured.

Retrieval of records CFR(s): 484.110(e) Standard: Retrieval of clinical records. A patient's clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first). This STANDARD is not met as evidenced by: Based on clinical record reviews and staff interview for one (1) of three (3) patients (Patient #2), the agency failed to ensure the patient received a copy of the patient's complete clinical record (hard copy or electronic form) upon request at the next home visit or within four (4) business days (whichever comes first). Failure to ensure the patient receives a copy of the patient care record within the required time frames has the potential for the patient to be unable to exercise his/her patient rights. The agency failed to ensure the patient received a complete copy of the clinical record when requested as evidenced by the following: Patient #2 – This 69-year-old patient with diagnoses that include unstageable pressure ulcer of right hip, encephalopathy and benign neoplasm of brain was admitted to the home health agency on 05/13/2024 and discharged on 07/30/2024. Review of letter dated 08/26/2024 from the patient to the agency revealed the patient requested a copy of their clinical record for the period from 04/29/2024 to 08/09/2024. Review of an attachment to a letter dated 10/10/2024 from the patient’s sister to the agency revealed a copy of the patient’s Registered Nurse Wound Care Revisit Note dated 07/02/2024 with a handwritten request from the sister requesting the wound photos and measurements from the identified visit. Review of the clinical record lacks documented evidence the agency sent the patient photographs of the patient’s wounds containing wound measurements once the agency was made aware that the record provided to the patient was incomplete. During interview on 03/05/2025 at 12:35 PM, the Interim Clinical Operations Manager stated all wound measurements are included in each wound care photo attachment taken by the clinician and are not contained in the clinician’s visit note documentation. During interview on 03/07/2025 at 10:47 AM, the Director of Compliance stated wound photos were not provided to the patient upon the patient’s 08/26/2024 request to receive a copy of the medical record as it was not part of the clinical record printing process per agency policy and procedure at that time. Additionally, the Director of Compliance stated the policy and procedure entitled “Medical Records” was revised 10/2024 to include provision of wound photos as part of the medical record when requested. During interview on 03/07/2024 at 10:30 AM, the Chief Nursing Officer, Administrator stated no wound photos were provided to the patient after the agency received the 10/10/2024 letter from the patient's sister requesting a wound photo and wound measurements from the 07/02/2024 visit note, because the sister was not authorized to receive patient record documentation.

The following statement of deficiencies represents the results of a partial extended re-certification survey of HCR Certified Home Health Agency and Long-Term Home Health Care Program conducted on 10/21/2024 to 11/05/2024 which included complaint investigations # NY0097425 and NY00104662. The allegations in complaints # NY0097425 and NY00104662 were determined substantiated. A standard re-certification survey was initiated on 10/21/2024. Deficient practices were identified within Level 1 standards in G- 536 (review of all current medications) on 10/23/2024 resulting in a partial extended survey. The survey consisted of a review of seventeen (17) clinical records including five (5) discharged records, eight (8) personnel records of professional personnel and seven (7) observational visits. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past twelve (12) months, agency’s Admission Packet, Infection control policies and protocols, contract, the Emergency Preparedness Plan, and Complaint Log. The current patient census is 1022. Pre-survey activities consisted of review on 10/08/2024 of the agency’s Health Commerce System account, Home Care Registry, Potentially Avoidable Report for 10/03/2023 -10/03/2024, the Home Health Agency Error Summary Report for 09/04/2023 to 09/06/2024, and the agency’s compliance with submission of statistical reports and emergency drills. The Chief Nursing Office/Administrator, Director of Patient Services Home Care of Central New York, Director of Patient Services Western New York, Clinical Information Analyst/ Occupational Therapist, and various professional staff were interviewed. Findings were reviewed at the exit conference on 11/05/2024. The following deficiencies are identified as a result of the survey: G0372, G0418, G0434, G0442, G0514, G0536, G0538, G0574, G0580, G0590, G0610, G0716, G01022, J1136, J1168, W0614.

The following statement of deficiencies represents the results of a partial extended re-certification survey of HCR Certified Home Health Agency and Long Term Home Health Care Program conducted on 10/21/2024 to 11/05/2024 which included complaint investigations # NY0097425 and NY00104662. The allegations in complaints # NY0097425 and NY00104662 were determined substantiated. A standard re-certification survey was initiated on 10/21/2024. Deficient practices were identified within Level 1 standards in G- 536 (review of all current medications) on 10/23/2024 resulting in a partial extended survey. The survey consisted of a review of seventeen (17) clinical records including five (5) discharged records, eight (8) personnel records of professional personnel and seven (7) observational visits. The survey included a review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past twelve (12) months, agency’s Admission Packet, Infection control policies and protocols, contract, the Emergency Preparedness Plan, and Complaint Log. The current patient census is 1022. Pre-survey activities consisted of review on 10/08/2024 of the agency’s Health Commerce System account, Home Care Registry, Potentially Avoidable Report for 10/03/2023 -10/03/2024, the Home Health Agency Error Summary Report for 09/04/2023 to 09/06/2024, and the agency’s compliance with submission of statistical reports and emergency drills. The Chief Nursing Office/Administrator, Director of Patient Services Home Care of Central New York, Director of Patient Services Western New York, Clinical Information Analyst/ Occupational Therapist, and various professional staff were interviewed. Findings were reviewed at the exit conference on 11/05/2024. The following deficiencies are identified as a result of the survey: G0372, G0418, G0434, G0442, G0514, G0536, G0538, G0574, G0580, G0590, G0610, G0716, G01022, J1136, J1168, W0614.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on record reviews and staff interviews, the agency failed to ensure that all completed Outcome and Assessment Information Set assessments (M0090) were transmitted to the State/Centers for Medicare and Medicaid Services within thirty (30) days of completion. This is evident for one (1) of one (1) clinical records reviewed that required transmission (Patient #9). Failure to ensure that all completed Outcome and Assessment Information Set assessments are transmitted to the Centers for Medicare and Medicaid Services contractor or state within 30 (thirty) days has the potential for negative patient outcomes. The agency failed to ensure that all completed Outcome and Assessment Information Set assessments (M0090) are transmitted to the Centers for Medicare and Medicaid Services contractor or state within 30 (thirty) days as evidenced by: Pre-survey the "Home Health Agency Error Summary Report" on 10/07/2024 revealed the agency has 1631 (one thousand six hundred and thirty-one) late submissions of the Outcome and Assessment Information Set assessments (M0090) from 09/04/2023 to 09/04/2024. Patient #9- This 62-year-old patient with diagnoses that include infection following procedure of other surgical site, paroxysmal atrial fibrillation and chronic systolic heart failure was admitted to the home care agency on 01/21/2024 and discharged on 04/26/2024. Review of the Registered Nurse Outcome and Assessment Information Set Start of Care completed by the Registered Nurse revealed the Outcome and Assessment Information Set Assessment (M0090) was completed on 01/21/2024. Review of the Home Health Agency Error Submission Report provided by the agency on 10/23/2024 at 11:14 AM revealed the patient’s Outcome and Assessment Information Set Assessment (M0090) was submitted on 04/23`/2024 (93 (ninety-three)) days after the assessment was complete. During interview on 10/23/2024 at 11:14 AM, the Chief Nursing Office/Administrator stated that due to their process of reviewing charts prior to submission, this can cause delays. They added that there have also been staff constraints, but the agency is working on fixing the issue.

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interviews for one (1) of seventeen (17) patients (Patient #: 14), the agency failed to obtain either the patient's or the patient's legal representative's signature confirming the patient received a copy of the patient rights and responsibilities at start of care (SOC). Failure to ensure patients have received notice of their rights and responsibilities has the potential for negative outcomes. The agency failed to obtain either the patient’s or the patient’s legal representative’s signature confirming the patient received a copy of the patient rights and responsibilities as evidenced by the following: Review of the agency policy entitled “Authorization for Services” last revised 04/2023 revealed the following: - “A patient’s Authorization and Acknowledgement (A&A) Form will be signed by the patient, patient’s legal representative or other self-selected representative, prior to the initiation of services. - If the clinician is unable to obtain the Authorization and Acknowledgement form at the time of Start of Care (i.e., patient lacks the capacity to sign the form/representative not present), the form may be mailed to the legal representative or other self-selected representative for signature.” Patient #14- This 93-year-old patient with diagnoses that include pressure ulcer of right buttock, stage two (2), pressure ulcer of the left buttock, stage two (2), and hypertensive heart disease with heart failure was admitted to the home health care agency on 09/29/2024. Review of the Patient Authorization and Acknowledgement (A&A_R3) form dated 09/29/2024 revealed that the “Patient unable to sign due to cognitive deficit and POA not available.” Additionally, there is no documentation to explain who signed the form on behalf of the patient and who is the authorized representative to make health care decisions on behalf of the patient. During an interview on 10/30/2024 at 11:19 AM, the Registered Nurse stated “I can’t recall who signed” the form. During an interview on 10/30/2024 at 11:20 AM, the Clinical Information Analyst stated there should be a copy of the POA and HCP and will look for it. As of exit, no additional information was provided to refute the findings.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on an observational home visit, agency policy, clinical record and interview with staff for one (1) of seventeen (17) patients (Patient #2), the agency failed to obtain patient consent for wound photography. Failure to include patient participation in, be informed about and consent or refuse care in advance of and during treatment has the potential to result in negative patient outcomes. The agency failed to obtain patient consent for wound photography as evidenced by the following: Review of the agency policy entitled “Wound Photography” last revised on 01/2022 revealed “Informed written consent for wound photography will be obtained from the patient, or the patient’s legal representative, electronically updated prior to taking pictures. The signed consent…only needs to be obtained once per admission. The patient or legal representative has the right to revoke consent anytime.” HV Patient #2- This 66-year-old patient with diagnoses that include skin graft (allograft) (autograft) infection, encounter for surgical aftercare following surgery on circulatory system, and squamous cell carcinoma of skin of scalp and neck was admitted to the home care agency on 10/05/2024. Review of the clinical record from 10/05/2024 to 10/29/2024 revealed wound photos were taken on 10/11/2024, 10/16/2024, 10/22/2024 and 10/23/2024. The clinical record lacks documented evidence that a consent for photograph of the patient’s wound was obtained prior to wound photo being taken. The agency failed to include the patient participation in, be informed about and consent or refuse care in advance of wound photography. During an interview on 11/01/2024 at 12:27 PM, the Director of Patient Services Finger Lakes/WNY Region stated that consent for wound photography was not located in the patient’s clinical record at this time.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on clinical record review and interview with agency staff, for one (1) of five (5) clinical records (Patient #: 10) lack documented evidence that the Notice of Medicare Non-Coverage (NOMNC) was provided to the patient before being discharged from the agency. Failure to complete the NOMNC form with the patient prior to discharge has the potential to result in negative patient outcomes. The agency failed to provide the patient with a NOMNC form prior to discharge as evidenced by the following: Patient #10- This 41-year-old patient with diagnoses that include pressure ulcer of sacral region, stage 3, multiple sclerosis, and neuromuscular dysfunction of bladder, unspecified was admitted to the home care agency on 04/24/2022 and discharged from the home care agency on 04/18/2023. Review of the Discharge-Transfer Summary Report dated 04/18/2023 revealed the following: - Status: Discharged - Date: 04/18/2023 The clinical record lacked documented evidence that the Notice of Medicare Non-Coverage (NOMNC) was discussed and provided to the patient before the patient was discharged from the agency. During interview on 11/01/2024 at 01:25 PM, the Clinical Information Analyst stated was unable to locate the NOMNC in the clinical record and would not have access to the form if the form was completed on paper and not submitted.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure, and interviews with staff, for one (1) of seventeen (17) patients (Patient #14), the agency failed to ensure the Registered Nurse (RN) completed an initial assessment of the patient within forty-eight (48) hours of referral, the patient’s return home, or on the physician-ordered start of care date. Failure to conduct an initial assessment within the required timeframe has the potential to result in unmet patient needs and negative patient outcomes. The agency failed to ensure the Registered Nurse (RN)/Physical Therapist (PT) conducted an initial assessment of the patient within forty-eight (48) hours of the referral as evidenced by the following: Patient #14- This 93-year-old patient with diagnoses that include pressure ulcer of right buttock, stage two (2), pressure ulcer of left buttock, stage two (2), and hypertensive heart disease with heart failure was admitted to the home care agency on 09/29/2024. Review of the Referral Completed Client Coordination Note dated 09/26/2024 revealed the following: - Is there a physician ordered SOC date (M0102): 09/28 The clinical record lacked documented evidence of the ordering provider ordered the SOC date on 09/28/2024. During interview on 10/30/2024 at 11:18 AM, the Director of Patient Services Finger Lakes/Western New York stated was not sure why the start of care was late and will look for additional information. As of exit, no additional evidence provided to refute the findings.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on clinical record review and interview with agency staff, for three (3) of seventeen (17) clinical records (Patient #'s: 2, 4, and 15) lack documented evidence of a complete review of all medications the patient currently uses to identify any potential adverse effects, drug reactions, or concerns including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. The agency failed to complete a comprehensive medication reconciliation as evidenced by the following: Review of the HCR Home Care “Medication Reconciliation Protocol dated 1.2022 revealed “Medication reconciliation is required at every in-home patient visit. The medication reconciliation process should include the following:… 3. Compare the current medication orders, discharge/transfer information, medication labels in the home and patient report how medications are taken a. Make note of any allergies, omissions, ineffective drug therapy, adverse events, side effects, drug interactions or contraindicated medications b. Notify the physician of discrepancies and medication issues and obtain updated orders as necessary c. Clinically significant medication issues need to be rectified by midnight of the following calendar day d. Communicate with the pharmacy, other ordering physicians, and the interdisciplinary team regarding medication discrepancies and changes as appropriate 4. Enter all ordered medications into the medical record a. If medications are missing from the home, notify the physician and document plan of how/when patient will obtain these medications 5. Communicate the reconciled medications list to the patient and caregiver a. Utilize teach back methods to ensure patient/caregiver understanding of understand the medication regiment b. Provide medications specific education and document patient’s understanding in HCHB c. Instruct patient/caregiver to inform HCR of any medication changes when they occur.” Patient #2- This 66-year-old patient with diagnoses that include skin graft (allograft) (autograft) infection, encounter for surgical aftercare following surgery on circulatory system, and squamous cell carcinoma of skin of scalp and neck was admitted to the home care agency on 10/05/2024. Review of the Registered Nurse Outcome and Assessment Information Set Note dated 10/05/2024 revealed the Registered Nurse documented no issues found with the medication reconciliation…(CC)(M2001) Drug Regimen Review: did a complete drug regimen review identify potential clinically significant medication issues? 0-no-no issues found during review. Review of the After Visit Summary dated 09/27/2024 revealed orders for: - acetaminophen 500 mg tablet take 1 tablet (500 mg total) by mouth every 6 hours as needed for fever, pain; - fluticasone 50 mcg/act nasal spray spray 2 sprays into nostril daily; - ibuprofen 200 mg tablet take 1 tablet (200 mg total) by mouth every 6 hours as needed for pain, fever; - nifedipine 90 mg 24 hr tablet take 1 tablet (90 mg total) by mouth daily. Swallow whole. Do not crush, break, or chew. Review of the Home Health Certification and Plan of Care for 10/05/2024 to 12/03/2024 revealed orders for: - tylenol 8 hr 650 mg tablet, extended release 1 tablet every 6 hours as needed for pain. Maximum daily dose of 4 tabs; - flonase allergy relief 50 mcg/actuation nasal spray, suspension 2 spray daily, one spray into each nostril daily; - ibuprofen 200 mg tablet 1 tablet oral every 6 hours as needed for pain, maximum daily dose of 4 tabs; - nifedipine ER 90 mg tablet, extended release, 1 tablet oral daily. The clinical record lacks documented evidence that the medication discrepancies for acetaminophen/tylenol, fluticasone/flonase, ibuprofen, and nifedipine were discussed/clarified with the provider or that a drug regimen review was completed. During interview on 10/31/2024 at 12:20 PM, the Registered Nurse stated medications are reconciled with a faxed note that is sent to the provider. During interview on 10/31/2024 at 12:23 PM, the Clinical Information Analyst/Occupational Therapist stated would look for the response from the provider to the faxed note submitted by the registered nurse. As of exit, no additional information provided to refute the findings. During interview on 10/31/2024 at 02:04 PM, the Director of Patient Services Finger Lakes/Western New York stated a drug regimen review is required, do not see that the medications were discussed. Patient #4- This 93-year-old (Therapy Only) patient with diagnoses that include age related osteoporosis with current pathological fracture right humerus, polyosetoarthritis unspecified, and polymyalgia rheumatica was admitted to the home care agency on 09/13/2024. Review of the agency protocol entitled “HCR Home Care Drug Regimen Review for Therapy Only Cases” dated December 11, 2012 revealed time points for completing DRR [at] SOC: must be completed within 5 days of the therapy SOC...CFSS ensures a “DRR Request” coordination note is in the record... - “DRR Request” coordination note routes to CFSS Coordination Notes - Drug Regimen Reviewer must be an RN (Registered Nurse). Review of the DRR Request Client Coordination Note dated 10/10/2024 revealed the Occupational Therapist documented the following: - Reason for DRR request (i.e. PT SOC, med change, new issue identified): PT only SOC - Date of visit note to review: 09/13/2024 - Indicate who should be contacted for the drug regimen review: Patient - Follow-up comment entered by Registered Nurse on 10/25/2024 - Nursing added into the case Review of the Physical Therapy Outcome and Assessment Information Set Note dated 09/13/2024 revealed the Physical Therapist documented the following: - Indicate results of the medication reconciliation (select all that apply): None of the above. No issues identified during medication reconciliation process. No issues found with the medication reconciliation… - …(N0415) High-risk drug classes use and indication: check if the patient is taking any medications by pharmacological classification. Not how it is used, in the following classes: E1. Anticoagulant… - …(CC) (M2001) Drug Regimen Review: Did a complete drug regimen review identify potential clinically significant medication issues? 0- No- No issues found during review. Review of the Home Health Certification and Plan of Care for 09/13/2024 to 11/11/2024 revealed the Physical Therapist documented the following orders: - alendronate 35 mg tablet oral 1 tablet weekly on Sunday; - aspirin 81 mg tablet, delayed release, oral 1 tablet daily; - calcium 600 +D(3) 600 mg-10 mcg (400 unit) tablet oral 2 tablet daily; - carvedilol 6.25 mg tablet oral 1 tablet 2 times daily; - docusate sodium 100 mg capsule oral 1 capsule 2 times daily; - duloxetine 20 mg capsules, delayed release oral 1 mg daily - furosemide 20 mg tablet oral 3 tablet daily - gabapentin 100 mg capsule oral 1 capsule daily - lidocaine pain relief 4% topical patch topical 1 adhesive patch, medicated daily, place patch over painful joints but not directly over open areas. Leave patch on for 12 hours and then off for 12 hours; - miconazole nitrate 2% topical powder topical per instructions 2 times daily apply thin layer to affected skin for fungal infection; - mineral oil topical per instructions 2 times daily 4 drops in each ear; - polyethylene glycol 3350 17 gram/dose oral powder 17 g daily, mix into 8 oz. drink of choice; - pramipexole 0.5 mg tablet oral 1 tablet daily; - pravastatin 10 mg tablet oral 1 tablet daily; - spironolactone 25 mg tablet oral 1 tablet daily. The clinical record lacks documented evidence that a medication review and drug regimen review was completed during the physical therapy start of care. During interview on 10/31/2024 at 11:25 AM, the Director of Patient Services Finger Lakes/Western New York stated would not be able to answer what was used by the Physical Therapist to reconcile medications. During interview on 10/31/2024 at 11:36 AM, the Director of Patient Services Finger Lakes/Western New York stated the physical therapist would have identified potentially clinically significant medication issues by looking if the medication in the system matched discharge instructions. Additionally, when the physical therapist signs off on the device, it would trigger a coordination note. Furthermore, there is no record because the system’s drug regimen review does not allow the clinician to sign out if it’s not done. However, there is no record generated in the medical record of the drug regimen review. During interview on 10/31/2024 at 11:49 AM, the Director of Patient Services Finger Lakes/Western New York stated the nurse should have followed-up with patient sooner than 10/10/2024 on medication understanding changes and instructions. Patient #5- This 82-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of right artificial knee joint, and supraventricular tachycardia unspecified was admitted to the home care agency on 10/08/2024. Review of the Physical Therapy Outcome and Assessment Information Set Note dated 10/08/2024 revealed the Physical Therapist documented the following: - Indicate results of medication reconciliation (select all that apply): Patient is not taking medications(s) listed on the referral - Indicate medications patient is not taking and reason why: Miralax… - (N0415) High-risk drug classes use and indication: check if the patient is taking any medication by pharmacological classification. Not how it is used. In the following classes: H1. opioid and l1. Antiplatelet… - …(CC)(M2001) Drug Regimen Review: did a complete drug regimen review identify potential clinically significant medication issues? Not assessed/no information. Review of the After Visit Summary dated 10/05/2024 revealed an order for the following medications: - amoxicillin 500 mg tablet 2,000 mg oral prn, 1 hour prior to dental procedures; - fluticasone furoate 200 mcg/actuation diskus inhaler 1 puff inhalation daily may thru september; - tizanidine 4 mg tablet 4 mg oral every 6 hours prn; - pregabalin 25 mg capsule 25 mg oral daily prn; - rosuvastatin 10 mg tablet 10 mg oral bedtime taking every other day - systane (PF) opht 1 drop ophthalmic daily Review of the Home Health Certification and Plan of Care for 10/08/2024 to 12/06/2024 revealed an order for the following medications: - amoxicillin 500 mg capsule oral 4 capsule daily as needed for dental procedures, max daily dose four capsules; - arnuity ellipta 200 mcg/actuation powder for inhalation by mouth 1 inhalation daily inhale one puff by mouth daily - tizanidine 4 mg tablet oral 1 tablet every 6 hours as needed for pain, maximum daily dose four tablets; - pregabalin 25 mg capsule oral 1 capsule daily as needed for pain, maximum daily dose one tablet - rosuvastatin 10 mg tablet oral 1 tablet every other day - systane balance 0.6% ophthalmic (EYE) eye drops 1 drop daily both eyes The clinical record lacks documented evidence that the medication discrepancies for amoxicillin, fluticasone furoate (arnuity ellipta), tizanidine, pregabalin, rosuvastatin, and systane were discussed/clarified with the provider and a drug regimen review was completed during the Physical Therapy admission. During interview on 10/29/2024 at 10:53 AM, the Physical Therapist stated did not document each medication discussed with the patient or discrepancies with discussed/clarified with provider and should have. Patient #6- This 87-year-old patient with diagnoses that include chronic diastolic (congestive) heart failure, longstanding persistent atrial fibrillation, and history of falling was admitted to the home care agency on 10/06/2024. Review of the Home Health Certification and Plan of Care for 08/15/2024 to 10/13/2024 revealed the following orders: - Skilled Nursing to reconcile medications every visit and provide education as necessary for knowledge deficit and medication changes. Facility manages/administers all meds for patient… - …Clopidogrel 75 mg oral tablet take 1 tablet by mouth daily; - Vitamin B12, 1,000 mcg oral tablet take 1 tablet by mouth daily; - Furosemide (Lasix) 20 mg oral tablet take 1 tablet by mouth every am; - Levothyroxine 25 mcg oral tablet take 1 tablet by mouth every am; - Fish oil- omega 3 fatty acids 1 gram oral capsule take 2 capsules by mouth daily; - Pantoprazole 40 mg tablet, delayed release, oral tablet take 1 tablet by mouth daily; - Tamsulosin 0.4 mg oral 24 hr capsule take 1 capsule by mouth daily Review of the Registered Nurse Outcome and Assessment Information Set Note dated 10/06/2024 revealed the Registered Nurse documented: - Indicate results of medication reconciliation (select) all that apply: No issues found with the medication reconciliation - Does the patient take any oral medications (includes OTC/Herbals)? Yes - Does the patient require mobility assistance/supervision/verbal cues to safely to access a beverage and their oral medications where they are routinely stored at the time of the SOC/ROC visit? (consider M1860 response) Yes - Indicate how the patient is managing their oral medications at SOC/ROC prior to the intervention from the Home Health Agency: Resides in a facility where staff administer medications… - …Indicate the anticipated discharge plan for medication management: Facility will administer medications… - …(N0415) High-risk drug classes use and indication: Check if the patient is taking any medications by pharmacological classification. Not how it is used. In the following classes: l1. Antiplatelet - M2001 Addresses if there were any clinically significant medication issues identified and if they were resolved by midnight of the next calendar day. - Clinically significant medication issues are potential nor actual medication issues that place the patient at risk for serious harm/death/hospitalization and require immediate communication and resolution with the physician - (CC) (M2001) Drug regimen review: did a complete drug regimen review identify potential clinically significant medication issues? ) No- no issues found during review - (QM) (M2010) patient/caregiver high risk drug education. Has the patient/caregiver instruction on special precautions for all high-risk medications (such as hypoglycemics, anticoagulants,, etc.) and how and when to report problems that may occur? 1- Yes The clinical record lacks documented evidence that the medication reconciliation, drug interaction was completed and discrepancies were discussed with the provider for the plan of care orders. During interview on 10/30/2024 at 10:44 AM, the Registered Nurse stated that the facility MAR would have been used for the medication reconciliation and any discrepancies discussed should have been documented in the medical record. During interview on 10/30/2024 at 10:44 AM, the Clinical Information Analyst/Occupational Therapist stated was unable to confirm what the facility MAR was that was used for the medication reconciliation. During interview on 10/31/2024 at 01:47 PM, the Clinical Information Analyst/Occupational Therapist stated the clinician is required to run the drug interaction because the clinician receives a “pop up note”. Additionally, there is a software limitation that affects all of the patients and is not aware of how the interaction can be included in the medical record once it is cleared by the clinician. Patient #10- This 41-year-old patient with diagnoses that include pressure ulcer of sacral region, stage 3, multiple sclerosis, and neuromuscular dysfunction of bladder, unspecified was admitted to the home care agency on 04/24/2022 and discharged from the home care agency on 04/18/2023. Review of the Registered Nurse Recertification with Skill Visit Note dated 02/17/2023 revealed the Registered Nurse documented the following: - Is the patient taking prescribed prescription or over the counter medications? Yes - Is the patient and/or caregiver able to participate in medication teaching as a part of this skilled nursing visit? Yes - Is the patient currently prescribed an injectable or intravenous medication? No - Indicate which medications were educated on during this visit (mark all that apply) oral medication(s) - Indicate details of oral medication teaching provided: (mark all that apply) name/description of medication, dosage, route, duration, intended use/expected actions, precautions/complications, procedures for a missed dose, refills, self-monitoring effectiveness and storage and expiration - ***Required***Indicate medication(s) educated on and/or update the prn medication understanding: All Meds discussed - Did the visit identify any issues or concerns related to the medications? - (New/changed medications. Side effects. Dosage concerns. Medication non-adherence etc) No concerns/issues identified related to the patient’s medications. Review of the Home Health Certification and Plan of Care for 02/18/2023 to 04/18/2023 revealed orders for the following medications: - allergy relief (fluticasone) 50 mcg/actuation nasal spray suspension 2 spray daily in each nostril; - baclofen 10 mg tablet oral 1 tablet 2 times daily - baclofen 5 mg tablet oral 1 tablet daily; - clonazepam 0.5 mg tablet oral 0.5 tablet 2 times a day as needed for anxiety, maximum daily dose 1 tablet; - cranberry capsule by mouth 1 capsule daily; - dulcolax (bisacodyl) 10 mg rectal suppository 1 suppository rectal daily as needed for constipation, maximum daily dose 1 suppository; - eliquis 5 mg tablet oral 1 tablet 2 times daily; - epinephrine 0.3 mg/0.3 ml injection syringe injection 0.3 mg as needed for food allergies; - famotidine 20 mg tablet oral 1 tablet 2 times daily - gilenya 0.5 mg capsule oral 1 capsule daily; - lamotrigine 25 mg tablet oral 2 tablet bedtime; - lyrica 50 mg capsule oral 1 capsule every am; - lyrica 75 mg capsule oral 1 capsule every pm; - multiple vitamins tablet oral 1 tablet daily; - norethindrone acetate 5 mg tablet oral 1 tablet daily; - ondansetron 4 mg disintegrating tablet oral 1 tablet 3 times a day as needed for nausea, maximum daily dose 3 tabs; - pantoprazole 40 mg tablet delayed release oral 1 tablet daily; - probiotic 10 billion cell capsule oral 1 capsule daily; - Zyrtec 10 mg tablet oral 1 tablet daily as needed for allergies, maximum daily dose 1 tab. Review of the clinical record lacks documented evidence that the medication reconciliation was completed, including but, not limited to the names/description, storage, expiration, and education on the oral, nasal, rectal and injected medications. During interview on 10/31/2024 at 04:22 PM, the Director of Patient Services Finger Lakes/Western New York stated a complete medication reconciliation was not done. Patient #12- This 66-year-old patient with diagnoses that include hypertensive heart disease with heart failure, unspecified diastolic (congestive) heart failure, and type two (2) diabetes mellitus without complications was admitted to the home care agency on 11/28/2023 and discharged from the home care agency on 01/26/2024. Review of the agency protocol entitled “HCR Home Care Drug Regimen Review for Therapy Only Cases” dated December 11, 2012 revealed time points for completing drug regimen review…anytime a therapist identifies a medication change. Review of the Physical Therapy Visit Note dated 12/13/2023 revealed the Physical Therapist documented: - Did the visit identify any issues or concerns related to medications(s)? - (New/changed medications. Side effects. Dosage concerns. Medication non-adherence etc) No concerns/issues identified related to the patient’s medications. Review of the Physician Order dated 12/13/2023 revealed the Physical Therapist spoke with Registered Nurse at MDs office to inform of BG readings in 20s-30s with no other symptoms. Per MD: patient is safe at home, stop taking glipizide and pioglitazone. Eat before bed and take BG in the night. Review of the “DRR Request” Client Coordination Note revealed the Physical Therapist documented the following: - Reason for DRR request (i.e. PT SOC, med change, new issue identified): med changed due to BG concerns - Date of visit note to review: 12/13 - Indicate who should be contacted for the drug regimen review: Patient - If someone other than the patient, ensure they are listed as contact in the demographic screen Review of the Other Additional Information Client Coordination Note dated 12/14/2024 revealed the Registered Nurse documented late entry: writer spoke with [Natalie] from PCP office to inform about BG readings and that patient refused 911 to be called. Waiting for further orders. Review of the Hospital Hold Client Coordination Note dated 12/15/2023 revealed the licensed practical nurse documented the following: - Hospital name: Highland Inpatient. HCC id following - PT DOB: [3/01/1958] - Situation/reason patient went hospital: - Barriers to returning home? (Y/N) - Case Manager(s) notified: (Y/N) - Hospitalization tracking details (entered by HCC and intake only) - Inpatient date: 12/14/2023 or observation date: - Hospital dx: Hypoglycemia - Facility MRN [E2147898] - Follow-up comment entered by Registered Nurse on 12/15/2023 TIF plotted. The clinical record lacks documented evidence that the medication reconciliation and drug regimen were completed. During interview on 10/30/2024 at 09:51 AM, the Physical Therapist stated medications were changed during this visit and a DRR request was completed for the Registered Nurse and Clinical Field Staff Supervisor (CFSS) to follow-up but the patient was admitted to the hospital before follow-up education could be provided to the patient. Patient #14- This 93-year-old patient with diagnoses that include pressure ulcer of right buttock, stage two (2), pressure ulcer of left buttock, stage two (2), and hypertensive heart disease with heart failure was admitted to the home care agency on 09/29/2024. Review of the SOC/ROC Client Coordination Note dated 09/29/2024 revealed the Registered Nurse documented “PT rest in ch upon arrival. Is alert, oriented to self, confused w/ dementia hx. Is HOH and has poor vision. PT’s med records are all locked up in main office and unobtainable during SOC per [Tanya]. PT poor historian.” Review of the Registered Nurse Outcome and Assessment Information Set Admission Note dated 09/29/2024 revealed the Registered Nurse documented the following: - Indicate results of medication reconciliation (select all that apply): No issues found with the medication reconciliation… - …High-risk drug classes… - …High-risk drug classes use and indication: check if the patient is taking any medications by pharmacological classification, Not how it is used, In the following classes: l1. Antiplatelet and J1. Hypoglycemic (including insulin)… - …(CC)(M2010) Drug Regimen Review: Did a complete drug regimen review identify any potential clinically significant medication issues? 0- No-No issues found during review. Review of the Home Health Certification and Plan of Care for 09/29/2024 to 11/27/2024 revealed the following medication orders: - acetaminophen 500 mg tablet oral 2 tablet every 4 hours as needed for pain, maximum daily dose 3-4 grams; - albuterol sulfate 2.5 mg/3 ml (0.083%) solution for inhalation nebulization 3 ml every 4 hours as needed for wheezing or shortness of breath via SAN, maximum daily dose 18 ml; - alprazolam 0.25 mg tablet oral 2 tablet 2 times a day as needed for anxiety, maximum daily dose 4 tabs; - aricept 10 mg tablet oral 1 tablet bedtime; - aspirin 81 mg tablet delayed release oral 1 tablet daily; - calmoseptine 0.44%-20.6% topical ointment topical 2 times daily buttocks wound care; - clotrimazole 1% topical cream topical per instructions daily to itching areas bilat legs; - fenofibrate 160 mg tablet oral 1 tablet daily; - glipizide 5 mg tablet oral 1 tablet daily; - perservision AREDS 2 plus multivitamin 200 mcg- 15 mcg- 5 mg- 1 mg capsule oral 1 capsule 2 times daily; - quetiapine 25 mg tablet oral 1 tablet at bedtime; - rybelsus 7 mg tablet oral 1 tablet daily; - silvadene 1% topical cream topical per instructions 2 times daily buttocks wound care; - spironolactone 25 mg- hydrochlorothiazide 25 mg tablet oral 1 tablet every other day - vitamin D3 125 mcg (5,000 unit) tablet oral 1 tablet weekly on Thursdays The clinical record lacks documented evidence that a medication reconciliation for the Registered Nurse Outcome and Assessment Information Set Admission was completed. During interview on 10/30/2024 at 11:23 AM, the Registered Nurse stated has trouble on the weekends with medication reconciliation because the facility staff is not present to allow access to the MAR. Patient #16- This 100-year-old patient with diagnoses that include hypertensive heart disease with heart failure, hypothyroidism, unspecified, and dementia in other diseases classified elsewhere, unspecified severity without behavioral disturbance, psychotic disturbance, mood disturbance and anxiety was admitted to the home care agency on 08/15/2024. Review of the Home Health Certification and Plan of Care for 08/15/2024 to 10/13/2024 revealed the following orders: - Acetaminophen 500 mg tablet oral two (2) tablet three (3) times daily as needed for pain, maximum daily dose three (3) tabs; - Amoxicillin 500 mg capsule four (4) capsule oral daily for pre-dental work; - Aripiprazole 2 mg tablet one (1) tablet oral one (1) tablet every am; - Aripiprazole 2 mg tablet two (2) tablet oral two (2) tablet at bedtime; - Cephalexin 500 mg capsule one (1) capsule oral daily start/end date 08/17/2024; - Dok 100 mg tablet one (1) tablet oral two (2) times daily; - Eliquis 2.5 mg tablet one (1) tablet oral two (2) times daily; - Furosemide 20 mg tablet one (1) tablet oral daily; - Guaifenesin 100 mg/ml 10 ml oral every four (4) hours as needed for cough, maximum daily dose x six (6); - Levothyroxine 112 mcg capsule one (1) capsule oral daily; - Maalox advanced 200 mg-200 mg- 20 mg/5 ml oral suspension 30 ml oral every four (4) as needed for constipation, maximum daily dose x 6; - Milk of Magnesia 400 mg/5 ml oral suspension 30 ml oral daily as needed for constipation, maximum daily dose x 1; - Miralax 17 gram/dose oral powder 17 gram oral daily as needed for constipation, maximum daily dose 17 gram; - Senexon-S 8.6-50 mg tablet one (1) tablet oral two (2) times daily; - Trazadone 50 mg tablet 0.5 tablet (1/2) oral three (3) times daily; - Vitamin D3 50 mcg (2,000 unit) capsule one (1) capsule oral daily. Review of the Registered Nurse Recertification with Skill Visit dated 10/09/2024 revealed the Registered Nurse documented the following: - Did the medication reconciliation process identify any discrepancies or concerns? No - Is the patient and/or caregiver able to participate in medication teaching as a part of this skilled nursing visit? No - Indicate the reason the patient and/or caregiver is unable to participate in medication teaching at this time: Dementia. The clinical record lacks documented evidence the medications were reconciled for the Registered Nurse recertification visit. During interview on 10/30/2024 at 02:36 PM, the Registered Nurse stated patient resides in an Assisted Living. Additionally, uses the facility medication list and speaks with the staff at the facility for changes to medication, etc. as the patient is very confused. Furthermore, the discussion with the provider for the medication reconciliation should have been documented and will be in the future. As of exit, no additional evidence provided to refute the findings. HV Patient #3- This 78-year-old patient with diagnoses that include left ankle external fixation, hypertensive chronic kidney disease and type 2 diabetes was admitted to the home care agency on 09/26/2024. Review of the referral to the home care agency dated 02/06/2024 revealed the following medication orders: - calcium citrate-vitamin D 315-250 milligrams- unit one (1) tablet, twice daily oral - cholecalciferol 1,000-unit tablet, two (2) tablets, daily oral - free style lancets for testing sugar daily - free style lite strips test strips for testing blood glucose daily - polyethylene glycol powder 17 grams daily oral - senna 8.6 milligram tablets, two (2) tablets, daily oral Review of the Home Health Certification and Plan of Care for 09/26/2024 to 11/24/2024 lacks orders for the identified medications. Review of the clinical record lacks documented evidence the Registered Nurse clarified the discrepancies between the referral and plan of care with the ordering physician. During interview on 10/31/2024 at 01:25 PM, the Registered Nurse stated of being unable to recall if the physician’s office was notified of the discrepancies between the referral and plan of care. Patient #8- This 66-year-old patient with diagnoses that include hyperglycemia, type 2 diabetes and chronic kidney disease was admitted to the home care agency on 08/01/2024 and discharged on 08/29/2024. Review of the Home Health Certification and Plan of Care for certification period 08/01/2024 to 09/29/2024 revealed an order for gabapentin 300 milligrams one (1) capsule at bedtime. The order is duplicate on the plan of care. Review of the clinical record lacks documentation of clarification of the identified medication discrepancy on the plan of care with the ordering physician. During interview on 11/01/2024 at 03:45 PM, the Registered Nurse was unavailable for interview. The Director of Patient Services acknowledged the order was duplicate on the plan of care. Patient #11- This 61-year-old patient with diagnoses that include brittle type 1 diabetes, Addison’s disease, hypothyroidism, and hypertensive chronic kidney disease was admitted to the home care agency on 01/23/2024 and discharged on 02/14/2024.This patient was identified on the Potentially Avoidable Event Patient Listing Report dated 10/03/2023 to 10/03/2024 for discharge to the community with Emergent Care for Hypo/Hyperglycemia. Review of the Home Health Certification and Plan of Care for certification period 01/23/2024 to 03/22/2024 revealed the patient was taking the following medications: - magnesium oxide 400 milligrams (24.3mg), 1 (one) tablet, 2 times oral daily; and - vraylar 1.5 milligram 1(one) capsule oral daily; The order is duplicate on the plan of care. Review of the clinical record lacks documentation of clarification of the identified medication discrepancies on the plan of care with the ordering physician. During interview on 10/30/2024 at 01:50 PM, the Registered Nurse was unavailable for interview. The Director of Patient Services acknowledged the order was duplicate on the plan of care. The Director of Patient Services added there was no documentation the discrepancies were clarified with the ordering physician. Patient #15- This 88-year-old patient with diagnoses that include Parkinson’s disease, coronary artery disease and right acetabulum and right inferior pubic ramus fracture was admitted to the home care agency on 09/30/2024. Review of the referral to the home care agency dated 09/24/2024 revealed the order for acetaminophen 500 mg milligrams take three tablets by mouth three times a day. Review of the Home Health Certification and Plan of Care for the certification period 09/30/2024 to 11/28/2024 lacks an order for the identified medication. Review of the clinical record lacks documented evidence that either the Physical Therapist or Registered Nurse contacted the physician regarding the discrepancies between the referral to the agency and the plan of care. During interview on 10/28/2024 at 04:32 PM, the Physical Therapist acknowledged being unaware of the identified discrepancy, therefore the physician was not notified. The Physical Therapist added that the medication should have been added to the plan of care.

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on observational home visits, clinical records and interview with staff for two (2) of seventeen (17) patients (Patient #’s: 2 and 5), the agency failed to determine the patient’s primary caregiver(s) willingness and ability to provide care and availability and schedules. Failure to determine the patient’s primary caregiver(s) willingness and ability to provide care and availability and schedule has the potential to result in negative patient outcomes. The agency failed to determine the willingness and availability of the patient’s primary caregiver(s) to provide care to the patient as evidenced by the following: HV Patient #2- This 66-year-old patient with diagnoses that include skin graft (allograft) (autograft) infection, encounter for surgical aftercare following surgery on circulatory system, and squamous cell carcinoma of skin of scalp and neck was admitted to the home care agency on 10/05/2024. Review of the Home Health Certification and Plan of Care for 10/05/2024 to 12/03/2024 revealed the order for the Skilled Nurse to provide wound care to scalp and left side of neck until healed: cleanse wound with wound cleanser or normal saline. Apply Dakin’s soaked gauze to scalp and neck. Cover with Tefla and tape to neck. Surgical net over head to keep dressing in place. Change daily and as needed for strikethrough drainage or dressing dislodgement using clean technique.- responsible parties for completing wound care: Skilled nurse/physician/patient- frequency of wound care to be performed by:- HCR Nurse two (2) times a week- caregiver and/or provider (specify): changed at otolaryngology weekly. Review of the Registered Nurse Outcome and Assessment Information Set Admission Visit Note dated 10/05/2024 revealed the Registered Nurse documented the following: Observed the patient with mock demonstration of wound care. Patient is independent with difficulty at times. During an observational home visit on 10/22/2024 at 11:30 AM, the patient stated was not able to do wound care on scalp due to the location and does not have someone else to provide wound care when the agency’s nurse or doctor’s office does not provide the wound care. The clinical record lacked documented evidence that a caregiver was able, available and willing to provide wound care when the agency and/or doctor’s office was not providing wound care to the patient. During interview on 10/30/2024 at 12:32 PM, the Registered Nurse stated the patient’s son was not available during the home visit to determine availability, ability and willingness to provide wound care to the patient on the days when the agency nurse and the doctor do not provide the wound care to the patient. HV Patient #5- This 82-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of right artificial knee joint, and supraventricular tachycardia unspecified was admitted to the home care agency on 10/08/2024. Review of the Home Health Certification and Plan of Care for 10/08/2024 to 12/06/2024 revealed the order for the Skilled Nurse to provide wound care to right posterior knee traumatic skin abrasion until healed: cleanse with soap and water, wound cleanser, or normal saline. Apply foam dressing as the primary dressing. Change three times weekly and as needed for strikethrough drainage or dressing dislodgement using clean technique.- Responsible parties for completing wound care: Skilled Nurse (patient unable to perform due to location) – frequency of wound care to be performed by:- HCR nurse: three (3) times weekly – caregiver and/or provider (specify): one (1) time weekly first week. Two (2) times second and third week. Review of the Registered Nurse Add-On Evaluation Note dated 10/10/2024 revealed the following: - Indicate client living arrangements: 0- lives alone… - …Indicate the concerns related to the patient’s willingness, competence, or compliance with providing the services/care needs per the plan of care: “Patient unable to care for wound on her own due to the position of the wound.” During an observational home visit on 10/23/2024 at 11:20 AM, the patient stated inability to do wound care on back of the leg and does not have a caregiver to help with wound care. The clinical record lacked documented evidence that a caregiver was able, available and willing to provide wound care when the agency was not providing the wound care to the patient. During interview on 10/30/2024 at 09:01 AM, the Registered Nurse stated a caregiver was not present during the visit and was unable to assess the ability, willingness, and availability of a caregiver to provide wound care to the patient when the agency does not.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on review of observational home visit, clinical records and staff interviews for one (1) of seventeen (17) patients (Patient #: 1) the agency failed to develop individualized plans of care that are complete and accurate and address the total needs of the patients. Failure to ensure that a comprehensive individualized plan of care is developed has the potential for unmet patient needs. HV Patient #1- This 73-year-old therapy only patient with diagnoses that include traumatic subarachnoid hemorrhage without loss of consciousness, fracture of sacrum, type 2 diabetes and atrial fibrillation was admitted to the home care agency on 10/03/2024. Review of the Referral for Services dated 09/25/2024 revealed the patient needed a shower chair for discharge. Review of the Home Health Plan of Care dated 10/03/2024 to 12/01/2024 lacks an order for a shower chair. During interview on 06/17/2021 at 12:45 PM, the Physical Therapist stated the shower chair should have been included on the plan of care but was not. The agency failed to develop individualized plans of care that are complete and accurate and address the total needs of the patients as evidenced by: Patient #12- This 66-year-old patient with diagnoses that include hypertensive heart disease with heart failure, unspecified diastolic (congestive) heart failure, and type two (2) diabetes mellitus without complications was admitted to the home care agency on 11/28/2023 and discharged from the home care agency on 01/26/2024. This patient was identified on the Potentially Avoidable Event Patient Listing Report dated 10/03/2023 to 10/03/2024 for discharge to the community with Emergent Care for Hypo/Hyperglycemia. A. Review of the Home Health Certification and Plan of Care for 11/28/2023 to 01/26/2024 revealed the order for the Skilled Nurse for instruction/reinforcement of diabetes management including: Diet, skin care, foot care, and medications to manage blood sugar. Patient/Caregiver to complete blood glucose testing as ordered by the physician. The patient independent with BG checks at ordered frequency of: Daily. Review of the Registered Nurse Outcome and Assessment Information Set Admission Visit Note dated 11/28/2023 revealed the Registered Nurse documented the following: - Does the patient have diabetes: Yes - Indicate how blood glucose levels are monitored: Patient/Caregiver via blood glucose meter - Was blood glucose history reviewed? Yes - Indicate the source of blood glucose readings: review of glucose log - Enter the highest and lowest blood sugar readings since the last nursing visit: 120-150 - Do the current readings suggest that the client’s blood sugar readings have been stable? Yes - Indicate how the blood glucose levels are maintained? Oral antidiabetic agent - Does the patient present with any signs and/or symptoms today that may be consistent with uncontrolled diabetes? No Review of the Home Health Certification and Plan of Care for 11/28/2023 to 01/26/2024 lacks an order for diabetic testing supplies. B. Review of the Home Health Certification and Plan of Care for 11/28/2023 to 01/26/2024 revealed the order for the Medical Social Services for evaluation to assess social and emotional factors related to the client’s illness, need for care, response to treatment and adjustment to care: to be followed by collaboration with the physician and nurse to develop plan of care. Reason for medical social work referral is: community resources, aide service, and ramp. Review of the undated HCR Home Care “Aide Service Request Protocol 2023” revealed instructions for requesting aide service during skilled CHHA episode: 1. Field Clinician- enter an Aide Service CHHA Request note to initiate request to staff aide services in the CHHA. *Do not enter orders/aide care plan added at this time as request must be reviewed. 2. CHHA PSC/CFSS- view the Aide Service CHHA Request note, keep workflow awaiting a LHCSA response via an Aide Service Request Follow Up Note. *Follow-up with LHCSA if response is not provided within 48-72 hours based upon requested start date. 3. LHCSA Team- review the Aide Service CHHA Request note. Reach out to the LHCSA representative to determine if the LHCSA can staff the request. LHCSA staff will respond within 48 hours. Enter Aide Service Request Follow Up Note to indicating if the request can be staffed. Clear the Aide Service CHHA Request note in LHCSA Intake workflow. Should the LHCSA be unable to staff the request immediately, the request will be held in the event that availability opens up…if request is declined: (*Leave/complete the template for the declined referral). Aide Service Request Follow Up Note. The request for CHHA aide services is declined: Aide service cannot be staffed at this time. Please follow up with the clinician/manager… 6. …If services are unable to be staffed: a. CFSS- Clear the aide Service CHHA Request note workflow; leave the Aide Service Follow Up Note. Contact the Clinical Manager and clinician to provide notification that service request cannot be fulfilled. b. CFSS/DON/Clinician: Determine follow-up plan to meet the patient needs, notify the patient and document accordingly. CFSS clears the Aide Service Request Follow Up Note. Review of the Aide Service Request Client Coordination Note dated 11/29/2023 revealed the Registered Nurse documented the following: - Requested service start date (MM/DD/YY): 12/4/23 - Requested day(s) and number of hour(s) per day: 1-2 hrs x 3 per week - Preferred time of day: Flexible (if there is a clinical need for a specific visit time, please explain in detail) - Special Skills (Hoyer Lift/Foley): - Special considerations (smoking/language/pets): 1 cat - Follow-up comment entered by [Debbie Rose], on 11/29/2023 Denied. See aide service follow up request coordination note. - Follow-up comment entered by Registered Nurse on 11/29/2023 Noted. Review of the Aide Service Request Follow Up Note dated 11/29/2023 revealed the request for CHHA aide services is declined: Aide service cannot be staffed at this time. Please follow up with the clinician/manager. Follow-up comment entered by Registered Nurse on 11/29/2023 Team notified. Review of the Master Social Work (MSW) Add-On Evaluation Visit Note dated 12/07/2023 revealed the MSW documented the following: - Indicate the client’s living arrangements: lives alone - Indicate the client’s caregiver status (mark all that apply): limited caregiver support to assist patient - Indicate findings related to the client’s social supports (mark all that apply): the client is isolated with limited to no social supports - Indicate client’s current functional mobility ability: independently ambulates with or without assistive devices - Indicate client’s current ability with personal care: needs assistance with personal care - Indicate client’s current ability without household management: needs assistance with household management The clinical record lacks documented evidence that the impact of available supports/assistance to the patient’s health management was fully assessed/addressed by the home care agency. Specifically, aide services determined to be appropriate during the initial Registered Nurse Admission on 11/28/2023 were not included on the plan of care orders and short term aide services were denied by the agency without additional follow-up for short term services. During interview on 10/29/2024 at 12:03 PM, the Registered Nurse stated the patient required aide services. Additionally, the Registered Nurse stated that the agency policy is that the Registered Nurse is not allowed to include the aide services on the Home Health Certification and Plan of Care. Furthermore, the need is determined by a submitted referral, the agency will then call the physician for the orders, if able to staff. During interview on 10/29/2024 at 12:04 PM, the Director of Patient Services Finger Lakes/Western New York stated was unaware of the request and will look into it further to see why short term aide services were not provided. As of exit, no additional information provided to refute the findings. During interview on 10/30/2024 at 10:14 AM, the Medical Social Worker stated that the patient lived alone with a cat, did not have an agreeable caregiver on a regular basis and was receiving personal care services before Medicaid coverage lapsed. Additionally, patient would have benefited from having aide services. Furthermore, patient was not seen again because of a hospitalization before the next scheduled visit. C. Review of the Home Health Certification and Plan of Care for 11/28/2024 to 01/26/2024 revealed the order for the Skilled Nurse to provide skilled teaching related to heart failure disease process including…check weight every day, call MD for weight gain greater than/equal to three (3) pounds/day or greater than/equal to five (5) pounds/week. The plan of care lacks documented evidence that the patient has a scale to weigh self-daily to report changes to the medical doctor as ordered. During interview on 10/29/2024 at 12:00 PM, the Registered Nurse stated was unable to recall if the patient had a scale which, should have been included on the plan of care. D. Review of the Home Health Certification and Plan of Care for 11/28/2024 to 01/26/2024 revealed the order for MSW effective 12/03/2023 one (1) week one (1), one (1) every two (2) weeks two(2). Review of the Missed Visit Notification Client Care Coordination Note dated 12/01/2024 revealed: - Reason for missed visit: SW visit moved to week of 12/4 - MD office was notified on: 12/1 - Spoke with: medical rep Samantha - Interdisciplinary communication provided to: - Additional questions for ASCS only: - Visit date (MM/DD/YY): - CM notified via e-mail (Name of CM): Review of the Physician Order dated 12/01/2023 revealed social work visit moved to the week of 12/3/2023. Spoke with medical rep Samantha at MD office and informed of change to order. Review of the Interdisciplinary Communication Client Coordination Note dated 12/04/2024 revealed the social worker documented that social work left voicemail for patient asking for a return call to schedule sw assessment. The clinical record lacks documented evidence that the patient requested the date change for the initial social work visit. During interview on 10/30/2024 at 10:08 AM, the social worker stated was unable to recall why the date for the social work visit was changed. As of exit, no additional evidence provided to refute the findings. E. Review of the Home Health Certification and Plan of Care for 11/28/2024 to 01/26/2024 revealed the diagnosis of Type two (2) diabetes mellitus without complications. Review of the Registered Nurse Visit dated 12/13/2023 revealed the Registered Nurse documented interventions provided: - Diabetes is classified as: Type 1 (your body does not produce insulin) or type 2 (your body doesn’t make enough insulin or does not use it well). - Gestational diabetes can occur during pregnancy due to increased insulin resistance. This may return to normal after the baby is born. During interview on 10/28/2024 at 04:59 PM, the Registered Nurse stated that the client does not have gestational diabetes and that the interventions should have been individualized to the patient. Patient #14- This 93-year-old patient with diagnoses that include pressure ulcer of right buttock, stage two (2), pressure ulcer of left buttock, stage two (2), and hypertensive heart disease with heart failure was admitted to the home care agency on 09/29/2024. A. Review of the Registered Nurse Outcome and Assessment Information Set Admission Visit Note dated 09/29/2023 revealed the Registered Nurse documented the following: - Does the patient have diabetes: Yes - Indicate how blood glucose levels are monitored: Physcian orders do not include blood glucose testing - Indicate how the blood glucose levels are maintained? Diet controlled and oral diabetic agent - Does the patient present with any signs and/or symptoms today that may be consistent with uncontrolled diabetes? No Review of the Home Health Certification and Plan of Care for 09/29/2024 to 11/27/2024 revealed the order for the Skilled Nurse for instruction/reinforcement of diabetes management including: Diabetic foot care and monitoring diabetic control. Skilled nurse will assess skin integrity as needed. Patient/caregiver are not required to monitor BG’s in the facility. Review of the Home Health Certification and Plan of Care for 09/29/2024 to 11/27/2024 lacks an order for who manages blood sugar testing and how the patient’s blood sugar is monitored. During an interview on 10/30/2024 at 11:29 AM, the Registered Nurse stated the patient is diabetic. Additionally, it is unclear how the patient’s blood sugar is managed by the facility. B. Review of the Home Health Certification and Plan of Care for 09/29/2024 to 11/27/2024 revealed the order for the Skilled Nurse to provide skilled teaching related to the signs and symptoms of heart failure exacerbation and associated self-monitoring techniques. -check weight every day, call MD for weight gain greater than/equal to three (3) pounds/day or greater than/equal to five (5) pounds/week. Review of the Home Health Certification and Plan of Care for 09/29/2024 to 11/27/2024 lacks an order for a scale to weigh. During interview on 10/30/2024 at 11:59 AM, the Registered Nurse stated unable to recall if the patient has a scale to weigh self. C. Review of the SOC/ROC Client Coordination Note dated 09/29/2024 revealed the Registered Nurse documented SOC on patient today who is a resident at the Willows Assisted Living. Writer assisted by PCA. The clinical record lacks documented evidence that the Registered Nurse verified the name of the aide service provider, type of aide services and frequency of aide services to the patient. During interview on 10/30/2024 at 11:51 AM, the Registered Nurse stated PCA is from the facility. D. Review of the Registered Nurse Outcome and Assessment Information Set Admission Note dated 09/29/2024 revealed the Registered Nurse documented incontinence protection pads and/or garments observed in the home. Review of the Home Health Certification and Plan of Care for 09/29/2024 to 11/27/2024 lacks an order for the incontinence supplies. During interview on 10/30/2024 at 12:02 PM, the Registered Nurse stated incontinence supplies should have been included and may have been overlooked. Patient #2- This 66-year-old patient with diagnoses that include skin graft (allograft) (autograft) infection, encounter for surgical aftercare following surgery on circulatory system, and squamous cell carcinoma of skin of scalp and neck was admitted to the home care agency on 10/05/2024. A. Review of the Registered Nurse Visit Note dated 10/11/2024 revealed the Registered Nurse documented that the patient “refused blood work last two appts states she would prefer not having it done through the agency and to continue getting it checked while at appts.” Review of the Home Health Certification and Plan of Care for 10/05/2024 to 12/03/2024 revealed the order for lab to perform venipuncture for CBC and CMP weekly results to physician, [Dr. Ellis], [Dr. Doerr], [Dr. Schuyler], [Dr. Thinzar] The plan of care revealed that there is no documentation in the plan of care to show what lab is responsible to perform the weekly CBC and CMP venipuncture. Specifically, whether the agency, doctor’s office, or an outpatient lab is to perform weekly venipuncture. During interview on 10/30/2024 at 12:36 PM, the Registered Nurse stated unable to recall the lab that was to perform the weekly venipuncture or when the last lab was drawn. Additionally, the Registered Nurse stated, “I just opened the patient and don’t have anything to do with the patient after the opening.” During interview on 10/30/2024 at 12:38 PM, the Clinical Information Analyst/Occupational Therapist stated that there should be clearer information in the patient’s medical record for the weekly venipuncture and will look. As of exit, no additional evidence provided to dispute the findings. During interview on 10/31/2024 at 02:30 PM, the Chief Nursing Officer/Administrator stated the ordering physician would make the decision on the lab that is responsible to perform weekly CBC and CMP venipuncture. Additionally, it is not the responsibility of the agency to follow up on lab orders. B. Review of the Home Health Certification and Plan of Care for 10/05/2024 to 12/03/2023 revealed the order for the Skilled Nurse to provide teaching related to wound healing principles, nutritional/hydration requirements and signs and symptoms of infection/wound complications to report to the home health agency. – wound care to scalp and l side of neck until healed: cleanse wound with wound cleanser or ns. Apply Dakins soaked gauze to scalp and neck. Cover with telfa and tape to neck. Surgical net over head to keep dsg in place. Change daily and PRN for strikethrough drainage or dressing dislodgement using clean technique. – Responsible parties for completing wound care: skilled nurse/physician/patient- frequency of wound care to be performed by HCR Nurse: two (2) times a week – caregiver and/or provider (specify): changed at otolaryngology weekly. Review of the Home Health Certification and Plan of Care for 10/05/2024 to 12/03/2024 lacks an order for Dakins to include strength and form of the medication to be applied to the patient’s wounds. During interview on 10/30/2024 at 12:35 PM, the Director of Patient Services Finger Lakes/Western New York stated that the strength and form of Dakins was not included on the plan of care and should have been. C. Review of the After Visit Summary dated 09/27/2024 revealed an order for mupirocin 2% ointment apply topically 2 times daily for infection of ears, nose, or throat to the following areas: scalp. Review of the HCR Home Care protocol entitled “Medication Reconciliation Protocol” dated 1.2022 revealed “4. Enter all ordered medications into the medical record a. if medications are missing from the home, notify the physician and document plan of how/when patient will obtain these medications.” Review of the Home Health Certification and Plan of Care for 10/05/2024 to 12/03/2024 lacks an order for Mupirocin 2% ointment. During interview on 10/30/202 at 12:46 PM, the Registered Nurse stated that only the medications observed in the home were included on the plan of care orders. Additionally, the medication was missing because it was left at the daughter’s home. HV Patient #6- This 87-year-old patient with diagnoses that include chronic diastolic (congestive) heart failure, longstanding persistent atrial fibrillation, and history of falling was admitted to the home care agency on 10/06/2024. A. During a home visit observation to observe the Skilled Nurse on 10/22/2024 at 09:15 AM, the patient stated didn’t feel therapy (Physical or Occupational) was needed but, was told it would be only once. Additionally, patient states is doing exercises that are in an exercise book and there are services provided at the facility if additional exercises are needed. Review of the Patient Authorization and Acknowledgement (A&A_R3) form dated 10/06/2024 revealed the Registered Nurse documented every attempt will be made to bill your insurance as follows…Service Type: Skilled Nursing. Review of the Home Health Certification and Plan of Care for 10/06/2024 to 12/04/2024 revealed the order for the Skilled Nurse two (2) times a week for one (1) week, one (1) time a week for four (4) weeks; Physical Therapist one (1) time a week for one (1) week; and Occupational Therapist one (1) time a week for one (1) week. Review of the Physical Therapy Add-On Evaluation Visit Note dated 10/07/2024 revealed the Physical Therapist documented patient declined need for further PT visits. Review of the Occupational Therapy Add-On Evaluation Visit Note dated 10/08/2024 revealed the Occupational Therapist documented the following: - Indicate therapy subjective “I’m fine. Don’t need any of this”… - …No further occupational therapy needs. Review of the clinical record lacks documented evidence that the patient was offered and agreeable to physical therapy and occupational therapy services. During interview on 10/30/2024 at 10:53 AM, the Registered Nurse stated that the patient was not agreeable to physical therapy or occupational therapy when the Patient Authorization and Acknowledgement (A&A_R3) form was signed. During interview on 10/30/2024 at 09:32 AM, the Physical Therapist stated that the patient did not want physical therapy services. During interview on 10/30/2024 at 01:02 PM, the Occupational Therapist stated that the patient did not want more than an evaluation from the occupational therapist. During interview on 10/30/2024 at 09:36 AM, the Director of Patient Services Finger Lakes/Western New York stated the patient should have been agreeable to occupational and physical therapy and will look for additional information. As of exit, no additional information provided to refute the findings. B. Review of the Home Health Certification and Plan of Care for 10/06/2024 to 12/04/2024 revealed the order for the Skilled Nurse to educate on use of compression garments: on during the day/off at HS. The plan of care lacks an order for compression stockings, including the compression level and length of stockings. During interview on 10/30/2024 at 11:02 AM, the Director of Patient Services Finger Lakes/Western New York stated that the order for compression stockings is incomplete and should include additional information. C. Review of the Home Health Certification and Plan of Care for 10/06/2024 to 12/04/2024 revealed the order for the Skilled Nurse to observe and assess patient to identify heart failure symptoms and intervene to minimize complications…check weight every day, call MD for weight gain greater than/equal to three (3) pounds/day or greater than equal to five (5) pounds/week. The plan of care lacks documented evidence that the patient has a scale to weigh self-daily to report changes to the medical doctor as ordered. During interview on 10/30/2024 at 11:10 AM, the Registered Nurse stated was unable to recall if the patient had a scale. Patient #16- This 100-year-old patient with diagnoses that include hypertensive heart disease with heart failure, hypothyroidism, unspecified, and dementia in other diseases classified elsewhere, unspecified severity without behavioral disturbance, psychotic disturbance, mood disturbance and anxiety was admitted to the home care agency on 08/15/2024. A. Review of the Registered Nurse Recertification with Skill Visit Note dated 10/09/2024 revealed the Registered Nurse documented the following: - Indicate genitourinary assessment findings (mark all that apply): incontinence protection pads and/or garments observed in home, family/caregiver report recent episode(s) of urinary incontinence, distance to bathroom/toilet affects episodes of urinary incontinence, and urgency/frequency. - Indicate details about incontinence (mark all that apply): wears briefs/pads, occasional dribbling, and difficulty accessing toilet. Review of the Home Health Certification and Plan of Care for 10/14/2024 to 12/12/2024 lacks an order for the urinary incontinence supplies. During interview on 10/30/2024 at 02:45 PM, the Registered Nurse stated the incontinence supplies should have been updated on the plan of care. B. Review of the Registered Nurse Recertification with Skill Visit Note dated 10/09/2024 revealed the Registered Nurse documented the following: - Was nutrition assessed? Yes - Indicate nutritional assessment findings (mark all that apply): 1- patient eats fewer than 2 meals per day, 7- patient takes 3 or more prescribed or over the counter drugs per day, 8- without wanting to, the patient has lost or gained over 10 pounds in the past 6 months, and 10- patient drinks less than four glasses of water per day…patient is…eating better, staff assisting with eating and patient using boost. Review of the Home Health Certification and Plan of Care for 10/14/2024 to 12/12/2024 lacks an order for the boost. During interview on 10/30/2024 at 02:50 PM, the Registered Nurse stated that the boost was omitted in error and should have been included on the plan of care. C. Review of the Registered Nurse Recertification with Skill Visit Note dated 10/09/2024 revealed the Registered Nurse documented DME/Supplies are recommended: rolling walker, wheelchair, elevated toilet seat, tub chair, hospital bed, lift recliner, reacher, and grab bars. Review of the Home Health Certification and Plan of Care for 10/14/2024 to 12/12/2024 lacks an order for the elevated toilet seat, tub chair, hospital bed, lift recliner, reacher, and grab bars. During interview on 10/30/2024 at 02:53 PM, the Registered Nurse stated the patient has been observed with the durable medical equipment and it should have been included on the plan of care. HV Patient #4- This 93-year-old (Therapy Only) patient with diagnoses that include age related osteoporosis with current pathological fracture right humerus, polyosetoarthritis unspecified, and polymyalgia rheumatica was admitted to the home care agency on 09/13/2024. A. Review of the Physical Therapy SOC Client Coordination note dated 09/16/2024 revealed the Physical Therapist documented caregiver availability/living situation: Daughter is returning home Wednesday, attempting to get other siblings to help, all 4 out of state. Also wish to set up aide services. Review of the Physical Therapy Outcome and Assessment Information Set Admission Note dated 09/13/2024 revealed the Physical Therapist documented “PT is currently receiving 24 hour care from her daughter whos from out of state who is returning home wednesday. She is hoping her siblings will help out when she returns home and that MSW can assist with finding long term aide. The clinical record lacks evidence that the Physical Therapist obtained an order for short term aide services to support the patient while healing from a right humerus fracture. During interview on 10/31/2024 at 11:39 AM, the Director of Patient Services Finger Lakes/Western New York stated the clinician should have discussed with the provider short term aide services for the patient and then deferred to long term care for long term aide services. B. During an observational home visit to observe the Occupational Therapist, on 10/22/2024 at 10:15 AM, the patient stated all children live out of town and that two daughters assist periodically when able. Additionally, patient stated is unhappy with aide services receives daily for one (1) hour in the morning and one (1) hour in the evening. Furthermore, prefers that daughter helps to resolve the aide issue with the agency that provides the service. Review of the Physical Therapist Visit Note dated 10/15/2024 revealed the Physical Therapist documented that the patient slept in a recliner. Review of the Physical Therapy Outcome and Assessment Information Set Admission Note dated 09/13/2024 revealed the Physical Therapist documented the following: - (QM)(M1100) Patient living situation: which of the following best describes the patient’s residential circumstance and availability of assistance? (check one box only) C- patient lives in congregate situation (For example, assisted living, residential care home) - (C1)(QM)(PRA)(M100C) Patient lives in congregate situation (for example assisted living, residential care home) 11- around the clock - Is the client receiving assistance from persons other than home care staff? 1- yes - Indicate the name/relationship of the person who provides assistance (other than home care staff): Occasionally daughters Heidi and Marcie and son Rick The clinical record lacks documented evidence that the Physical Therapist verified the name and type of congregate living situation, the name of the aide service provider, type of aide services and frequency of aide services to the patient. During interview on 10/30/2024 at 09:24 AM, the Physical Therapist stated that the patient resides at Legacy at Park Crescent and receives aide services two times daily. Additionally, the aide in the evening did not show up to provide patient with evening services. Furthermore, without evening services, the patient decided to sleep in the recliner. Patient #10- This 41-year-old patient with diagnoses that include pressure ulcer of sacral region, stage 3, multiple sclerosis, and neuromuscular dysfunction of bladder, unspecified was admitted to the home care agency on 04/24/2022 and discharged from the home care agency on 04/18/2023. A. Review of the Registered Nurse Recertification with Skill Visit Note dated 02/17/2023 revealed the Registered Nurse documented that the patient has an urostomy and the following supplies were delivered: 2- ABD pad 5x9 ST (BX) Mckesson (70592000)- Box; 1- promogran prisma ag 4x4 (BX) MA028; 2- Eakin seals convactec 839002 Barr ring 2 opn XW (BX)- box; 2- Barr strips brava OST Crescent (BX)- box coloplast 120700- box; 1- adhesive remover wipes Hollister 7760 (BX)- box; 2- coloplast 16840 1pc URO (BX)- box. Review of the Home Health Certification and Plan of Care for 02/18/2023 to 04/18/2023 revealed the Registered Nurse documented the following DME and supplies: hospital bed, lift, rails/grab bars, shower/tub equipment, wheelchair, ABD pad, briefs/bladder control pads, catheter- supplies, cotton tipped applicators, dressing-antimicrobial, dressing foam, dressing honey, dressing transparent film, gauze, ostomy supplies, respiratory supplies and wound cleanser. Review of the Home Health Certification and Plan of Care for 02/18/2023 to 04/18/2023 lacks an order that includes who manages the urostomy, including stoma management and supplies. During an interview on 10/31/2023 at 04:33 PM, the Director of Patient Services Central New York stated it is unclear who manages the urostomy. During interview on 11/01/2024 at 10:55 AM, the Chief Nursing Officer/Administrator stated that the agency has to provide supplies needed to the patient, even if the agency does not manage what the supplies are used for, for example an urostomy. B. Review of the Registered Nurse Recertification with Skill Visit Note dated 02/17/2023 revealed the Registered Nurse documented the following: - Indicate any health-related/psychosocial needs identified: (mark all that apply) Mental health/coping concerns reported or suspected (anxiety, depression, self-harm) cognitive or physical impairment(s) that potentially impacts coping/recovery independence in the home and in the community… - Indicate prior hospitalization pattern and health status: (mark all that apply) History of non-compliance adhering to disease management recommendations… -Activity: chairbound… - Indicate musculoskeletal assessment findings: (mark all that apply) decreased strength, limited range of motion, and contractures…In what extremities does decreased strength exist? (mark all that apply) 5- lower bilat - In what extremities does limited range of motion exist? (Mark all that apply) 5- lower bilat -In what extremities do contractures exist? (mark all that apply) 5- lower bilat… -(E)(GG0130C4) Self-care toileting hygiene follow-up performance: The ability to maintain perineal hygiene. Adjust clothes before and after voiding or having a bowel movement. If managing an ostomy, include wiping the opening but not managing equipment. Code the patient’s usual performance at follow-up for each activity using the 6-point scale if activity was not attempted at follow-up, code the reason. Coding: safety and quality of performance- if helper assistance is required because patient’s performance is unsafe or of poor quality, score according to amount of assistance provided. 01. Dependent- Helper does all of the effort. Patient does none of the effort to complete the activity. Or, the assistance of 2 or more helpers is required for the patient to complete the activity… -(E)(GG0170F4) Mobility toilet transfer follow-up performance: The ability to get on and off a toilet or commode, code the patient’s usual performance at follow-up for each activity using the 6-point scale if activity was not attempted at follow-up, code the reason. Coding: safety and quality of performance- if helper assistance is required because patient’s performance is unsafe or of poor quality, score according to amount of assistance provided. 01. Dependent- Helper does all of the effort. Patient does none of the effort to complete the activity. Or, the assistance of 2 or more helpers is required for the patient to complete the activity… -(QM)(M1840) Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. 4- is totally dependent in toileting. Review of the Home Health Certification and Plan of Care for 02/18/2023 to 04/18/2023 lacks documented evidence of who assists patient with ADLs. During an interview on 10/31/2024 at 04:37 PM, the Clinical Information Analyst/Occupational Therapist stated that the patient has been on services since 2021 and receives aide services. Patient #5- This 82-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of right artificial knee joint, and supraventricular tachycardia unspecified was admitted to the home care agency on 10/08/2024. Review of the After Visit Summary (used as the patient discharge summary) printed on 10/05/2024 revealed an order for polyethylene glycol 17 gram packet 17 gram oral daily in the morning. Review of the Home Health Certification and Plan of Care for 10/08/2024 to 12/06/2024 lacks an order for polyethylene glycol. During interview on 10/29/2024 at 10:57 AM, the Physical Therapist stated if the medication was included on the discharge summary, it should have been included on the plan of care and must have been omitted in error.

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 clinical record review and interview with agency staff, for one (1) of seventeen (17) patients (Patient #: 8), the agency failed to ensure services and treatments are administered in accordance with physician orders. The agency failed to ensure services and treatments are administered in accordance with physician orders as evidenced by the following: Patient #8- This 66-year-old patient with diagnoses that include hyperglycemia, type 2 diabetes and chronic kidney disease was admitted to the home care agency on 08/01/2024 and discharged on 08/29/2024. Review of the Home Health Certification and Plan of Care dated 08/01/2024 revealed the following orders for Skilled Nursing: 1 (one) visit every week for 4 (four) weeks. Review of the clinical record from 08/18/2024 to 08/24/2024 lacks documented evidence that Skilled Nurse visits occurred or documentation that the physician was notified of the missed visits. During interview on 10/30/2024 at 03:37 PM, the Registered Nurse stated the patient was contacted, but is unsure why there is no documentation to show contact was made.

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 agency protocol, clinical records and interview with agency staff for two (2) of seventeen (17) patients (Patient #'s: 2 and 4), the agency staff failed to promptly alert the physician to any changes in the patient's condition that suggests the need to alter the plan of care (POC). Failure to promptly notify the physician to any changes in the patient's condition that suggests the plan of care should be altered has the potential to result in unmet patient needs and negative patient outcomes. The agency failed to notify the physician to changes in the patient’s condition as evidenced by the following: Patient #17- This 77-year-old patient with diagnoses that include atrial fibrillation, bradycardia, left hip arthroplasty and essential hypertension was admitted to the home care agency on 10/06/2024. Review of the Physical Therapy Routine Visit Note dated 10/21/2024 revealed the PTA documented the patient reported vertigo, chills headache nausea and chest pains during the ortho appointment today. The physical therapist stated the patient was advised by ortho physician to call the primary care physician. Review of the clinical record lacks documented evidence the Physical Therapist notified the physician promptly of the patient’s report of vertigo, chills, headache, nausea, and chest pains reported at the 10/21/2024 visit. During interview on 10/30/2024 at 2:25 PM, the Physical Therapist Assistant stated the physician should have been notified of the symptoms reported on the 10/21/2024 visit. The agency failed to notify the physician to changes in the patient’s condition as evidenced by the following: Review of the HCR Home Care Protocol entitled “Standards of Care Documentation Protocol” revised on 3.2022 revealed Section 7: Changes in patient’s condition “Any changes in patient’s condition (even a slight change, such as increased rales heard upon lung auscultation) must be reported same day to the physician.” Patient #2- This 66-year-old patient with diagnoses that include skin graft (allograft) (autograft) infection, encounter for surgical aftercare following surgery on circulatory system, and squamous cell carcinoma of skin of scalp and neck was admitted to the home care agency on 10/05/2024. Review of the Registered Nurse Visit Note dated 10/08/2024 revealed the Registered Nurse documented the following for blood pressure: - Reading: 168/90 - Physician contacted: no - Comments: Sys notified provider Review of the Home Health Certification and Plan of Care for 10/05/2024 to 12/03/2024 revealed the order for the licensed professional to report vital signs falling outside of the following established parameters: Temp 101, Pulse 110, Resp 28, Systolic BP 160, Diastolic BP 90, Pain 6, and O2 Sat 100. The clinical record lacks documented evidence including, the date, time, and name of the physician who was notified of the patient’s increased blood pressure reading. During interview on 10/31/2024 at 01:51 PM, the Director of Patient Services Finger Lakes/Western New York stated that the vital signs were out of the parameters and there should have been communication with the provider. During interview on 10/31/2024 at 01:53 PM, the Director of Patient Services Central New York stated that there should be communication with the physician documented and will look for it. As of exit, no additional information provided to refute the findings. Patient #4- This 93-year-old (Therapy Only) patient with diagnoses that include age related osteoporosis with current pathological fracture right humerus, polyosetoarthritis unspecified, and polymyalgia rheumatica was admitted to the home care agency on 09/13/2024. Review of the Physical Therapist Visit Note dated 10/04/2024 revealed the Physical Therapist documented the following: - Does the patient have edema or swelling? (May be cardiac or non-cardiac in nature) Yes. - Indicate location of the edema swelling: - ***see reference*** Lower right and lower left - Indicate characteristics of edema (lower right): 1+ (mild pitting, slight indentation that disappears rapidly) - Indicate characteristics of edema (lower left): 1+ (mild pitting, slight indentation that disappears rapidly) - Does the patient have a diagnosis of heart failure? Yes - Is the edema being monitored as a symptom related to the diagnosis of heart failure? Yes - Indicate the clinical impression of the patient’s observed or reported edema? Baseline- not new or worsened; and Review of the Physical Therapist Visit Note dated 10/11/2024 revealed the Physical Therapist documented the following: - Does the patient have edema or swelling? (May be cardiac or non-cardiac in nature) Yes. - Indicate location of the edema swelling: - ***see reference*** Lower right and lower left - Indicate characteristics of edema (lower right): 1+ (mild pitting, slight indentation that disappears rapidly) - Indicate characteristics of edema (lower left): 2+ (moderate pitting, indentation disappears in 10-15 seconds) - Does the patient have a diagnosis of heart failure? Yes - Is the edema being monitored as a symptom related to the diagnosis of heart failure? Yes - Indicate the clinical impression of the patient’s observed or reported edema? Worsening Review of the Physical Therapy Outcome and Assessment Information Set Admission Note dated 09/13/2024 revealed the Physical Therapist documented that the patient does not have edema. Review of the Home Health Certification and Plan of Care for 09/13/2024 to 11/11/2024 revealed the order for the Physical Therapist to provide skilled teaching related to the signs and symptoms of heart failure exacerbation and associated self-monitoring techniques. Check weight every day. Call MD for weight gain greater than/equal to 3 pounds/day or greater than 5 pounds/week. The clinical record lacks documented evidence that the physician was notified of the patient’s increased edema. During interview on 10/30/2024 at 09:20 AM, the Physical Therapist stated that the physician was not notified of the patient’s increased edema and should have been. Patient #5- This 82-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of right artificial knee joint, and supraventricular tachycardia unspecified was admitted to the home care agency on 10/08/2024. Review of the untitled wound photo [right posterior knee] revealed the following wound measurements: On 10/8/2024: - Width: 3.9 cm - Length: 3.6 cm - Area: 14.0 cm2 - Depth: 0.0 cm On 10/10/2024: - Width: 2.8 cm - Length: 1.5 cm - Area: 4.2 cm2 - Depth: 0.1 cm On 10/17/2024: - Width: 1.7 cm - Length: 1.2 cm - Area 2.0 cm2 - Depth: 0.1 cm On 10/23/2024: - Width: 1.9 cm - Length: 1.4 cm - Area: 2.7 cm2 - Depth: 0.0 cm; and Review of the right posterior knee wound photo revealed the following wound measurements: On 10/25/2024: - Width: 2.1 cm - Length: 1.6 cm - Area: 3.4 cm2 - Depth: 0.1 cm The clinical record lacks documented evidence that the physician was notified of the changes in patient’s wound measurements. During interview on 10/31/2024 at 10:50 AM, the Director of Patient Services Finger Lakes/Western New York stated the changes in wounds should have been reported to the physician and were not. Patient #10- This 41-year-old patient with diagnoses that include pressure ulcer of sacral region, stage 3, multiple sclerosis, and neuromuscular dysfunction of bladder, unspecified was admitted to the home care agency on 04/24/2022 and discharged from the home care agency on 04/18/2023. Review of the coccyx wound photo revealed the following wound measurements: On 03/03/2023: - Width: 1.6 cm - Length: 2.1 cm - Area: 3.4 cm2 - Depth: 1.5 cm On 03/10/2023: - Width: 1.8 cm - Length: 2.2 cm - Area: 4.0 cm2 - Depth: 1.5 cm On 03/16/2023: - Width: 1.5 cm - Length: 1.9 cm - Area 2.8 cm2 - Depth: 2.1 cm On 03/30/2023: - Width: 1.7 cm - Length: 1.8 cm - Area: 3.1 cm2 - Depth: 1.5 cm; and Review of the untitled wound photo[coccyx] revealed the following wound measurements: On 3/24/2023: - Width: 2.6 cm - Length: 2.0 cm - Area: 5.2 cm2 - Depth: 1.0 cm The clinical record lacks documented evidence that the physician was contacted for changes in the measurements of the wounds. During interview on 11/01/2024 at 01:47 PM, the Director of Patient Services Finger Lakes/Western New York stated that it would be expected that the physician would be contacted for changes, according to agency policy. Patient #14- This 93-year-old patient with diagnoses that include pressure ulcer of right buttock, stage two (2), pressure ulcer of left buttock, stage two (2), and hypertensive heart disease with heart failure was admitted to the home care agency on 09/29/2024. Review of the untitled wound photo [bilateral buttock] revealed the following wound measurements: On 09/29/2024: - Width: 0.0 cm - Length: 0.0 cm - Area: 0.0 cm2 - Depth: 0.0 cm On 10/21/2024: - Width: 0.8 cm - Length: 1.6 cm - Area: 1.3 cm2 - Depth: 0.0 cm; and Review of the buttock wound photo revealed the following wound measurements: On 10/04/2024: - Width: 0.0 cm - Length: 0.0 cm - Area: 0.0 cm2 - Depth: 0.0 cm; and Review of the right buttock wound photo revealed the following wound measurements: On 10/10/2024: - Width: 1.0 cm - Length: 1.3 cm - Area: 1.3 cm2 - Depth: 0.2 cm On 10/15/2024: - Width: 0.8 cm - Length: 1.6 cm - Area: 1.3 cm2 - Depth: 0.2 cm; and Review of the left buttock wound photo revealed the following wound measurements: On 10/10/2024: - Width: 0.9 cm - Length: 1.0 cm - Area: 0.9 cm2 - Depth: 0.4 cm On 10/15/2024: - Width: 2.0 - Length: 2.0 cm - Area: 4.0 cm2 - Depth: 0.0 cm The clinical record lacks documented evidence that the physician was contacted for changes in the measurements of the wounds. During interview on 10/29/2024 at 10:32 AM, the Registered Nurse stated the physician was notified of the changes but, it was not documented and should have been.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interview for five (5) of seventeen (17) patients (Patient #'s: 2, 4, 5, 9, 10), the agency failed to ensure the patient/caregiver receives appropriate education regarding the care and services identified in the plan of care (POC). Failure to provide appropriate education has the potential to result in the patient receiving inadequate care and could result in patient harm. Patient #9- This 62-year-old patient with diagnoses that include infection of right thoracotomy wound infection, paroxysmal atrial fibrillation and chronic systolic heart failure was admitted to the home care agency on 01/21/2024 and discharged on 0426/2024. Review of the Registered Nurse OASIS (Outcome and Assessment Information Set) Admission Note dated 01/21/2024 revealed the Registered Nurse documented the following: -Indicate what services/care needs are provided by the caregiver as part of the plan of care: IV ATBX (intravenous antibiotic). -Are there any concerns with the caregiver willingness, competence, or compliance with providing the services/care needs per the orders (including frequency): Yes. -Indicate the concerns related to caregiver willingness, competence, or compliance with providing the services/care needs per the plan of care: Needs further teaching for IV ATBX. -Indicate the follow up plan to ensure that the patient receives services/care needs at the required frequency: Skilled Nurse Visit tomorrow to observe patient/caregiver administer IV push antibiotic (Daptomycin IV q 24 hrs.). Review of the Skilled Nurse Visit Note Report dated 01/22/2024 revealed the Skilled Nurse documented the following: Does this patient receive IV therapy? N/A, not within License Practical Nurse (LPN) scope of practice. Review of the clinical record lacks documented evidence the patient received education and training/redemonstration regarding administering of the IV antibiotic. It is unclear when education was provided to the patient, and if there is evidence that the patient/caregiver was able to administer the Intravenous medication. During interview on 11/01/2024 at 02:37 PM, the Clinical Information Analyst stated the visit made on 01/22/2024 should have been made by the Registered and is unsure why this did not occur. The Clinical Information Specialist added that there is no documented evidence the Registered Nurse observe the patient/caregiver demonstrate administering the medication. The agency failed to ensure the patient/caregiver received appropriate education regarding the care and services identified in the plan of care (POC) as evidenced by: Patient #5- This 82-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of right artificial knee joint, and supraventricular tachycardia unspecified was admitted to the home care agency on 10/08/2024. A. Review of the Registered Nurse Add-On Evaluation Visit Note dated 10/10/2024 revealed the Registered Nurse documented the following interventions were provided during the visit: 1. Instruct client/caregiver on disease state management including actions to prevent decline to current status…4. Instruct the client/caregiver on infection prevention/control recommendations…infections can happen by touching a surface/object that has the virus on it and then touching your own eyes, mouth or nose. The clinical record lacks documentation of the patient’s response to the instructions provided by the Registered Nurse during the visit. During interview on 10/30/2024 at 09:02 AM, the Registered Nurse stated the patient’s response to the education should have been documented clearer. B. During an observational home visit on 10/23/2024 at 11:20 AM, the patient stated inability to do wound care on back of the leg and does not have a caregiver to help with wound care. Review of the Narrative Client Coordination Note dated 10/15/2024 revealed the Registered Nurse documented the following: - the patient reports the dressing falls off and will not stay on it that area due to the bend in the knee - skilled services/education provided: wound healing, signs of infection, diet for wound healing, elevating and when to use ice to the incision, steristrips to fall off on their own The clinical record lacks documentation of the patient’s response to the education provided by the Registered Nurse during the visit. During interview on 10/29/2024 at 04:13 PM, the Registered Nurse stated wound care was not taught to the patient because it “fell off” and responses to education were not documented. C. Review of the Occupational Therapy Add-On Evaluation Visit Note dated revealed the Occupational Therapist documented the following interventions were provided during the visit: 1. Instruct client/caregiver actions to prevent decline to current status, (such as: edema management, pressure relief and management of shortness of breath and pain)…5. Provide skilled therapy (related to upper extremity ROM and strengthening, functional activity and cognitive/visual function, with change in number cues provided and progression in level of assistance provided). Indicate reps, sets, frequency and resistance. -OT Details/Comments: instructed patient on sts in armless chair. The clinical record lacks documentation of the patient’s response to the education provided by the Occupational Therapist during the visit. During interview on 10/29/2024 at 11:25 AM, the Occupational Therapist stated patient’s response was not documented and should have been. Additionally, will update the patient’s responses for future visits. D. Review of the Skilled Nurse Registered Nurse Wound Care Revisit Note dated 10/17/2024 revealed the Licensed Practical Nurse documented the following: - Skilled Services/education Provided: VSS Cardio and Pulmonary Assessment completed no concerns wound care provided per orders. Pictures taken - Patient/Caregiver response: Patient tolerated well voiced no concerns - Interventions provided: 1. Instruct on environmental safety issues to resolve immediate safety threats…3. Instruct client/caregiver on care of wound and provide wound assessment and wound care as ordered by the physician…Instructed on S/S of infection to wound (redness, swelling, odor). The clinical record lacks documentation of the patient’s response to the education provided by the Licensed Practical Nurse during the visit. During interview on 10/29/2024 at 12:15 PM, the Licensed Practical Nurse stated the patient’s response to education provided during the visit was not documented and should have been. E. Review of the Physical Therapist Visit Note dated 10/17/2024 revealed the Physical Therapist documented the following intervention was completed during the visit: 14. Instruct the client/caregiver on infection prevention/control recommendations. Details/Comments: Reinforced prior instructions. The clinical record lacks documentation of the patient’s response to the education provided by the Physical Therapist during the visit. During interview on 10/29/2024 at 09:23 AM, the Physical Therapist stated the education was taught to the patient and response should have been documented. HV Patient #2- This 66-year-old patient with diagnoses that include skin graft (allograft) (autograft) infection, encounter for surgical aftercare following surgery on circulatory system, and squamous cell carcinoma of skin of scalp and neck was admitted to the home care agency on 10/05/2024. A. Review of the Registered Nurse Outcome and Assessment Information Set Admission Visit Note dated 10/05/2024 revealed the Registered Nurse documented the following: 2. Review patient/caregiver competency in providing treatment as ordered by the MD. (ex. Wound care...) …Details/Comments: Observed the patient with mock demonstration of wound care. Patient is independent with difficulty at times. Review of the Home Health Certification and Plan of Care for 10/05/2024 to 12/03/2024 revealed the order for the Skilled Nurse to provide teaching related to wound healing principles, nutritional/hydration requirements and signs and symptoms of infection/wound complications to report to the home health agency. -wound care to scalp and left side of neck until healed: cleanse wound with wound cleanser or normal saline. Apply Dakin’s soaked gauze to scalp and neck. Cover with Tefla and tape to neck. Surgical net over head to keep dressing in place. Change daily and as needed for strikethrough drainage or dressing dislodgement using clean technique.- responsible parties for completing wound care: Skilled nurse/physician/patient- frequency of wound care to be performed by:- HCR Nurse two (2) times a week- caregiver and/or provider (specify): changed at otolaryngology weekly. During an observational home visit on 10/22/2024 at 11:30 AM, the patient stated was not able to do wound care on scalp due to the location and shrugged shoulders when asked if someone else can do it on the days when the agency or provider are not providing wound care. Additionally, patient stated does not have someone else to provide wound care when the agency’s nurse or doctor’s office does not provide the wound care. The clinical record lacks documented evidence that the patient was able to demonstrate wound care proficiently to complete on the days that the HCR nurse and otolaryngology office does not. During interview on 10/31/2024 at 12:42 PM, the Registered Nurse stated that the patient has a daughter and son but, they were not available for wound care teaching. B. Review of the Registered Nurse Visit Note dated 10/08/2024 revealed the Registered Nurse documented the following: - blood pressure reading of 168/90… - …patient experiencing diarrhea… - …patient stated that she had not yet taken today’s dose of BP meds due to stomach upset related to abx Review of the Home Health Certification and Plan of Care for 10/05/2024 to 12/03/2024 revealed the following orders: - Skilled Nurse may instruct and reinforce medication teaching related to the use of medications to treat disease processes. Skilled nurse to monitor the effectiveness of drug therapy, adverse drug reactions, and significant side effects and how and when to report problems that may occur… - …Skilled Nurse for medication management teaching: patient/caregiver needs further education on management of medications. Would like a mediset… - …Skilled Nurse to instruct on hypertension to include the disease process, signs and symptoms, complications, and management… - …Skilled Nurse to instruct on Diarrhea including: signs and symptoms of diarrhea, risk factors and measures to prevent/manage diarrhea. The clinical record lacks documented evidence that the Registered Nurse instructed the patient on medications, such as the name, dose, route, quantity, frequency, any special instructions and/or side effects, during the visit. Additionally, the clinical record lacks documented evidence that the patient was instructed on hypertension and/or diarrhea. During interview on 10/31/2024 at 01:51 PM, the Director of Patient Services Finger Lakes/Western New York stated that it is expected that the nurse provides education on medications related to blood pressure and upset stomach/diarrhea. Additionally, the nurse should document the patient’s response to any education provided. Patient #4- This 93-year-old (Therapy Only) patient with diagnoses that include age related osteoporosis with current pathological fracture right humerus, polyosetoarthritis unspecified, and polymyalgia rheumatica was admitted to the home care agency on 09/13/2024. A. Review of the Occupational Therapist Visit Note dated 09/18/2024 revealed the Occupational Therapist documented that the following interventions were provided during the visit: 1. Instruct client/caregiver actions to prevent decline to current status, (such as edema, management, pressure relief and management of shortness of breath and pain…10. Instruct patient/caregiver on the signs and symptoms of heart failure exacerbation and associated self-monitoring techniques…Symptoms of heart failure that should be reported include: increased shortness of breath, weakness, fatigue, increased swelling in legs, feet or ankles, weight gain, abdominal bloating/discomfort, loss of appetite, cold clammy, skin, chest pressure, coughing white sputum production, walking suddenly with shortness of breath, need for increased number of pillows to sleep, inability to lay flat, anxiety and mental status changes. The clinical record lacks documentation of the patient’s response to the instructions provided by the Occupational Therapist during the visit. During interview on 10/30/2024 at 01:27 PM, the Occupational Therapist stated the patient’s response to the education provided during the visit was not documented and should have been. B. Review of the Physical Therapist Visit Note dated 10/17/2024 revealed the Physical Therapist documented the following interventions were provided during the visit: 1. Instruct patient/caregiver in proper techniques to facilitate safe bed mobility…5. Instruct client in balance training activities to reduce fall risk…overhead reaching. The clinical record lacks documentation of the patient’s response to the instructions provided by the Physical Therapist during the visit. During interview on 10/30/2024 at 09:28 AM, the Physical Therapist stated the patient’s response to the education provided during the visit was not documented. Additionally, the patient did fine with the exercises. Patient #10- This 41-year-old patient with diagnoses that include pressure ulcer of sacral region, stage 3, multiple sclerosis, and neuromuscular dysfunction of bladder, unspecified was admitted to the home care agency on 04/24/2022 and discharged from the home care agency on 04/18/2023. A. Review of the Registered Nurse Recertification with Skill Visit Note dated 02/17/2024 revealed the Registered Nurse documented the following interventions were provided during the visit: 1. Instruct the patient/caregiver on the definition of multiple sclerosis, disease process, signs/symptoms of exacerbation, and disease progression…2. Instruct the patient/caregiver on self-management techniques for multiple sclerosis including preventing exacerbation, managing symptoms, and energy conservation techniques…engage community resources such as support groups and exercise groups in the area. The clinical record lacks documentation of the patient’s response to the education provided by the Registered Nurse during the visit. During interview on 11/01/2024 at 10:44 AM, the Clinical Information Analyst/Occupational Therapist stated the narrative note includes the patient/caregiver response was reverbalized understanding and should have included what the patient verbalized. B. Review of the Skilled Nurse Visit Note dated 03/16/2024 revealed the Licensed Practical Nurse documented the following interventions were provided during the visit: 1. Instruct the client/caregiver on risk factors for pressure ulcers and preventative measures to prevent skin breakdown…6. Instruct client/caregiver on care of wound and provide wound assessment and wound care as ordered by the physician…instructed on S/S of infection to wound (redness, drainage, odor). The clinical record lacks documentation of the patient’s response to the education provided by the Licensed Practical Nurse during the visit. During interview on 10/29/2024 at 02:16 PM, the Licensed Practical Nurse stated the patient’s response to the education provided during the visit was not documented and should have been. Patient #12- This 66-year-old patient with diagnoses that include hypertensive heart disease with heart failure, unspecified diastolic (congestive) heart failure, and type two (2) diabetes mellitus without complications was admitted to the home care agency on 11/28/2023 and discharged from the home care agency on 01/26/2024. A. Review of the Registered Nurse Visit Note dated 12/13/2023 revealed the Registered Nurse instructed the client/caregiver on the disease process and management of diabetes…diabetes is classified as: type 1 (your body does not produce insulin) or type 2 (your body doesn’t make enough insulin or doesn’t use it well …wear a medical alert bracelet…annual eye exam…test before you eat and two hours after…nutritional diet…blood glucose testing…keep a blood sugar log…observed patient test blood sugar…observed caregiver test blood sugar. Review of the Home Health Certification and Plan of Care for 11/28/2023 to 01/26/2024 revealed the diagnosis of type two (2) diabetes mellitus without complications. The clinical record lacks the documented responses of the client/caregiver to the diabetic education provided by the Registered Nurse to the client/caregiver. During interview on 10/28/2024 at 05:13 PM, the Registered Nurse stated that the response of the client should have been included when the education was provided. B. Review of the DRR Request Client Coordination Note dated 12/13/2023 revealed the physical therapist documented the following: - Reason for DRR request (i.e. PT SOC, Med Change, New issue identified): Med change due to bg concerns - Date of visit note: 12/13 - Indicate who should be contacted for the drug regimen review: Patient Review of the Home Health Certification and Plan of Care for 11/28/2023 to 01/26/2024 revealed the diagnosis of type two (2) diabetes mellitus without complications. Review of the Home Health Certification and Plan of Care for 11/28/2023 to 01/26/2024 revealed the following orders: - Skilled Nurse to review medication profile and reconcile medications. Skilled Nurse may instruct and reinforce medication teaching related to the use of medications to treat disease processes. Skilled nurse to monitor the effectiveness of drug therapy, adverse drug reactions, and significant side effects, and how and when to report problems that may occur… - Glipizide 10 mg tablet 0.5 (1/2) tablet (5mg) oral daily - Metformin 500 mg tablet one (1) tablet oral two (2) times daily - Pioglitazone 15 mg tablet one (1) tablet oral daily. Review of the Registered Nurse Visit Note dated 12/13/2023 revealed the Registered Nurse documented: - Is the patient and/or caregiver able to participate in medical teaching as part of the skilled nursing visit? Yes - Indicate who was taught on medications during the skilled nursing visit: Patient - ***Required***Document medication(s) educated in the PRN understanding section or free text here*** Hypoglycemics - Is the patient currently prescribed an injectable or intravenous medication? No - Did the patient identify any issues or concerns related to medication(s)? - (New/changed medications. Side Effects. Dosage Concerns. Medication non-adherence etc): No concerns/issues identified related to the medications. Review of the Physician Order dated 12/13/2024 revealed the Physical Therapist spoke with Registered Nurse at MDs office to inform of bg readings in 20s-30s with no other symptoms. Per MD: patient is safe at home, stop taking glipizide and pioglitazone. Eat before bed and take bg in the night. Review of the Hospital Hold Client Coordination Report dated 12/15/2023 revealed the following: - Hospital Name: Highland Inpatient. HCC is following - PT DOB: [3/1/1958] - Situation/Reason patient went to the hospital: - Barriers to returning home (Y/N) - Case Manager(s) notified: Y/N? - Hospitalization tracking details (entered by HCC and intake only) - Inpatient Date: 12/14/2023… - Hospital Dx: Hypoglycemia - Facility MRN: E2147898 - Follow-up comment entered by Registered Nurse on 12/15/2023 - TIF plotted. The clinical record lacks documented evidence that the patient was educated on hypoglycemics. Specifically, Glipizide, Metformin and Pioglitazone. During interview on 10/28/2024 at 05:02 PM, the Registered Nurse stated was unable to recall what hypoglycemic medications were discussed with the patient. Patient #16- This 100-year-old patient with diagnoses that include hypertensive heart disease with heart failure, hypothyroidism, unspecified, and dementia in other diseases classified elsewhere, unspecified severity without behavioral disturbance, psychotic disturbance, mood disturbance and anxiety was admitted to the home care agency on 08/15/2024. Review of the Registered Nurse Recertification with Skill Visit Note dated 10/09/2024 revealed the Registered Nurse documented instructed on importance of daily weight monitoring including…maintain a daily weight log…reviewed a local list of local urgent care centers, etc. Review of the clinical record lacks documented evidence of patient’s response to the education provided by the Registered Nurse. During interview on 10/30/2024 at 03:15 PM, the Registered Nurse stated the education provided to the patient should include a response and be individualized. Additionally, the education should include that the facility monitors the patient’s weight. Furthermore, a local list of urgent care centers was not provided, the patient was instructed to contact emergency services.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for eight (8) of seventeen (17) patients (Patient #'s 2, 4, 5, 8, 10, 13, 14, and 16), the agency failed to prepare and document complete clinical progress notes. Failure to prepare or document complete and accurate clinical and progress notes has the potential for unmet patient needs. The agency failed to prepare and document complete clinical progress notes as evidenced by: Patient #8- This 66-year-old patient with diagnoses that include hyperglycemia, type 2 diabetes and chronic kidney disease was admitted to the home care agency on 08/01/2024. Review of the Skilled Nursing Visit Note dated 08/02/20204 revealed the Skilled Nurse documented that the patient’s blood glucose levels are monitored via blood glucose meter. Review of Skilled Nurse Visit Note dated 08/15/20204 revealed the Skilled Nurse documented the Physician is monitoring A1C via lab testing. Review of the Home Health Certification and Plan of Care for the certification period from 08/01/2024 to 09/29/2024 revealed the patient was ordered to monitor blood glucose at home. The documentation is inconsistent. It is unclear if the patient is monitoring blood glucose via blood glucose monitor or via A1C lab testing. During interview on 10/30/2024 at 3:25 PM, the Director of Patient Care Services stated the clinician was unavailable for interview. The Director of Patient Services acknowledged that the documentation is unclear. Patient #13- This 82-year-old patient with diagnoses that include unspecified fracture of left calcaneus, essential hypertension and type 2 diabetes mellitus with diabetic neuropathy was admitted to the home care agency on 09/23/2024. Review of the Visit Note Reports for visit dates 10/08/2024, 10/14/2024, and 10/22/2024 revealed the Physical Therapist documented the following: Does the patient have diabetes? No. During interview on 10/28/2024 at 11:47 AM, the Physical Therapist stated that the documentation was an error. The Physical Therapist stated they are aware the patient has diabetes. The agency failed to prepare and document complete clinical progress notes as evidenced by: Patient #5- This 82-year-old patient with diagnoses that include aftercare following joint replacement surgery, presence of right artificial knee joint, and supraventricular tachycardia unspecified was admitted to the home care agency on 10/08/2024. A. Review of the Registered Nurse Add-On Evaluation Visit Note dated 10/10/2024 revealed the Registered Nurse documented the skin color surrounding the skin was normal. During interview on 10/30/2024 at 08:55 AM, the Registered Nurse stated that the wound color around the wound was red and normal was selected in error. B. Review of the Skilled Nurse registered Nurse Wound Care Revisit Note dated 10/17/2024 revealed the Licensed Practical Nurse documented no necrotic tissue type and normal skin color surrounding the wound. During interview on 10/29/2024 at 12:14 PM, Director of Patient Services Finger Lakes/Western New York stated that the wound assessment was documented incorrectly. Additionally, the wound base looks 100% yellow and skin color around the wound is red in the wound photo. C. Review of the Skilled Nurse registered Nurse Wound Care Revisit Note dated 10/19/2024 revealed the Licensed Practical Nurse documented pain level of 0 in Vital Signs and pain level of 4 in the pain assessment. During interview on 10/31/2024 at 10:08 AM, the Director of Patient Services Finger Lakes/Western New York stated that there is a discrepancy and is unable to clarify the discrepancy on behalf of the unavailable clinician. D. Review of the Skilled Nurse registered Nurse Wound Care Revisit Note dated 10/19/2024 revealed the Licensed Practical Nurse documented does this patient receive IV therapy? N/A- not within LPN scope of practice. During an interview on 10/31/2024 at 10:19 AM, Director of Patient Services Finger Lakes/Western New York stated that the patient does not have an IV and that the clinician documented the answer in error. Patient #10- This 41-year-old patient with diagnoses that include pressure ulcer of sacral region, stage 3, multiple sclerosis, and neuromuscular dysfunction of bladder, unspecified was admitted to the home care agency on 04/24/2022 and discharged from the home care agency on 04/18/2023. A. Review of the Registered Nurse Recertification with Skill Visit Note dated 02/17/2023 revealed the Registered Nurse documented for the #2- mid- coccyx, pressure ulcer stage III- HCBS wound a depth description of partial thickness. During interview on 11/01/2024 at 10:40 AM, the Director of Patient Services Finger Lakes/Western New York stated the wound depth is not documented correctly and should have been documented as full thickness for the stage III wound. B. Review of the Physical Therapist Visit Note dated 03/23/2024 revealed the Physical Therapist documented indicate if a report of visit findings was provided to other HCR staff? N/A- no other disciplines involved, visit completed by case manager. During interview on 10/29/2024 at 02:51 PM, the Physical Therapist nursing is involved and that the answer was selected in error. C. Review of the Skilled Nurse registered Nurse Wound Care Revisit Note dated 10/19/2024 revealed the Licensed Practical Nurse documented does this patient receive IV therapy? N/A- not within LPN scope of practice. During interview on 10/31/2024 at 10:19 AM, the Director of Patient Services Finger Lakes/Western New York stated that the patient does not have an IV and it was documented in error by the licensed practical nurse. Patient #14- This 93-year-old patient with diagnoses that include pressure ulcer of right buttock, stage two (2), pressure ulcer of left buttock, stage two (2), and hypertensive heart disease with heart failure was admitted to the home care agency on 09/29/2024. A. Review of the Registered Nurse Visit Note dated 10/04/2024 revealed the Registered Nurse documented for wound #5- multi-low buttock- left- pressure ulcer stage II- HCHB a depth description of full thickness and for wound #6- multi-low buttock- right- pressure ulcer stage II- HCHB a depth description of full thickness. During interview on 10/29/2024 at 09:59 AM, the Registered Nurse stated the wound depth was documented in error for the stage II pressure ulcer and should have been documented as partial thickness. B. Review of the Registered Nurse Visit Note dated 10/10/2024 revealed the Registered Nurse documented wound #5- multi-low buttock- left- pressure ulcer stage II- HCHB skin color surrounding wound was normal and for wound #6- multi-low buttock- right- pressure ulcer stage II- HCHB skin color surrounding wound was normal. During interview on 10/29/2024 at 10:23 AM, the Registered Nurse stated the wound color surrounding the wounds was a little bluish in color and normal was documented in error. C. A. Review of the Skilled Nurse Registered Nurse Wound Care Revisit Note dated 10/21/2024 revealed the Licensed Practical Nurse documented does the patient receive IV therapy? N/A- not within the LPN scope of practice. During interview on 10/31/2024 at 03:43 PM, the Director of Patient Services Finger Lakes/Western New York stated that the patient does not have an IV. Patient #16- This 100-year-old patient with diagnoses that include hypertensive heart disease with heart failure, hypothyroidism, unspecified, and dementia in other diseases classified elsewhere, unspecified severity without behavioral disturbance, psychotic disturbance, mood disturbance and anxiety was admitted to the home care agency on 08/15/2024. A. Review of the Home Health Certification and Plan of Care for 10/14/2024 to 12/12/2024 revealed orders for the walker, wheelchair, dressing- xeroform and gauze. Review of the Registered Nurse Recertification with Skill Visit Note dated 10/09/2024 revealed the Registered Nurse documented integumentary ICC…no problems identified...patient wound has healed. During interview on 10/30/2024 at 03:03 PM, the Registered Nurse stated that the patient did not have a wound and the wound supplies were documented in error. B. Review of the Registered Nurse Recertification with Skill Visit Note dated 10/09/2024 revealed the Registered Nurse documented instruct on use of compression garments as ordered by the physician. Review of the Home Health Certification and Plan of Care for 10/14/2024 to 12/12/2024 lacks an order for compression stockings. During interview on 10/30/2024 at 03:14 PM, the Registered Nurse stated that the compression stockings were documented in error and that the patient does not wear compression stockings. Patient #2- This 66-year-old patient with diagnoses that include skin graft (allograft) (autograft) infection, encounter for surgical aftercare following surgery on circulatory system, and squamous cell carcinoma of skin of scalp and neck was admitted to the home care agency on 10/05/2024. Review of the Registered Nurse Outcome and Assessment Information Set Admission Note dated 10/05/2024 revealed the Registered Nurse documented that the wound measurements for wound #2- cervical left surgical incision- HCBS length, width, depth (CM) were 2.5 x 1 x 0, respectively. Review of the undated HCR Home Care agency policy entitled “Wound Care Standards of Practice” revealed “Measure the length, width, and depth in centimeters, with the length defined as the longest measurement along the head-to-toe (12 to 6) axis, and the width being perpendicular from length along the body’s horizontal axis (3-9). The greatest depth is noted and recorded with a cotton-tipped applicator. -Note: the depth of the wound may be “0” for a closed surgical wound or if it’s filled with necrotic tissue, but if there is an open wound with minimal depth, the wound should at least be documented as 0.1 cm.” During interview on 10/30/2024 at 12:39 PM, the Registered Nurse stated that the wound was open and there should have been some depth documented. Patient #4- This 93-year-old (Therapy Only) patient with diagnoses that include age related osteoporosis with current pathological fracture right humerus, polyosetoarthritis unspecified, and polymyalgia rheumatica was admitted to the home care agency on 09/13/2024. A. Review of the Occupational Therapist Visit Note dated 09/18/2024 revealed the Occupational Therapist documented pain level of 3 in the vital signs and a pain level of 2 in the pain assessment. During interview on 10/30/2024 at 01:23 PM, the Occupational Therapist stated that there was a discrepancy in the documentation of pain level for the visit. Additionally, was unable to recall which pain level was documented in error.

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 interview with staff for one (1) of five (5) discharged patient records (Patient #: 10), the agency failed to document a complete agency discharge summary, discipline discharge (Outcome and Assessment Information Set discharge assessment), and failed to communicate the discharge from services and the agency with the physician, and all other disciplines involved in the plan of care. Failure to document a complete discharge summary, discharge from discipline and communicate the discharge with other disciplines including the physician has the potential for negative patient outcomes. The agency failed to document a complete agency discharge summary and communicate with all disciplines involved in the patient’s care including the physician as evidenced by the following: Patient #10- This 41-year-old patient with diagnoses that include pressure ulcer of sacral region, stage 3, multiple sclerosis, and neuromuscular dysfunction of bladder, unspecified was admitted to the home care agency on 04/24/2022 and discharged from the home care agency on 04/18/2023. Review of the Interdisciplinary Communication Client Coordination Note dated 04/14/2023 revealed the following: - “Upon arrival grandma leaving for cardiologist apt [appointment] - PT [patient] noted to bed in bed. Bed noted to have stool on sheets, in pts pants, up pts back, and on pts hands. Per pt, her aide is in the hospital and she has no back up aide services. This writer questioned pt if grandma is able to help. Per pt grandma throws up and is unable to help clean up pt. Per pt she has no back up outside of HCR nurses. - Pt laying on bed on back. Phone at bedside. Writer informed pt she would take a moment to call supervisor. Writer will be back momentarily. Pt agreed to POC. - This writer took a moment to call HCR supervisor due to concerns of unsafe living conditions supervisor agreed. - Called MD office. Spoke with... - Called 911. Pt refused to go to hospital. EMS called hospital to encourage pt to go. EMS promised pt she would be back home tomorrow to get her to go.” Review of the Interdisciplinary Communication Client Coordination Note dated 04/14/2023 revealed the Registered Nurse documented Spoke with person from Adult Protective Services who stated case cannot be opened at this time due to pt in hospital. Once pt discharged from hospital her request is HCR call Adult Protective then.” Review of the Physician Order dated 04/17/2023 revealed the patient was being discharged from the agency without a visit per patient request. A phone call to the doctor's office was made to inform. "SN effective 04/09/2023- no visits requested/scheduled." Review of the Registered Nurse Discharge- Data Collection Only dated 04/14/2023 revealed the Registered Nurse documented the following: - (QM) (M2410) To which inpatient facility has the patient been admitted? N/A- no inpatient facility admission… - ... (QM) (M2420) Discharge Disposition: Where is the patient after discharge from your agency? (choose only one answer) 1- Patient remained in the community (without formal assistive services) During interview on 11/01/2024 at 01:22 PM, the Chief Nursing Officer/Administrator stated that the patient went into the hospital because the patient's aide was in the hospital and the patient's grandmother was not able to provide care. Additionally, the agency for the aide was not contacted to discuss the situation and inquire if another aide was available. During interview on 11/01/2024 at 01:58 PM, the Director of Patient Services Finger Lakes/Western New York stated that there is no requirement for discharge from physical therapy because nurse went out and deemed the living situation unsafe. Additionally, Outcome and Assessment Information Set (Discharge from Agency) Note was not required because of patient request for discharge. During interview on 11/01/2024 at 02:12 PM, the Clinical Information Analyst stated was unable to print the fax submission to provider with the discharge summary that included authenticated date and time of submission.

The following statement of deficiencies represents the results of a partial extended re-certification and focused COVID-19 infection control survey of HCR Certified Home Health Agency conducted on 10/12/2021 through 11/10/2021 which included complaint investigation # NY00283755. The allegations in complaint # NY00283755 were determined substantiated. A standard re-certification survey was initiated on 10/12/2021. Deficient practices were identified within Level 1 standards in G-574 (incomplete Plan of Care) resulting in a partial extended survey. The survey consisted of a review of 17 (seventeen) clinical records including five (5) discharge records, eight (8) personnel records for personnel, one (1) contract, and six (6) observational home visits. The survey included a review of the Long-Term Home Health Care Program (LTHHCP), review of pertinent policies and procedures, Quality Improvement Meeting minutes for the past 12 months, agency’s Admission Packet, the Emergency Preparedness Plan, and Complaint Log. Pre-survey activities consisted of review on 10/04/2021of the agency’s Health Commerce System account, iQIES Reports for the period 07/2020 - 06/2021, and the agency’s compliance with submission of statistical reports and emergency drills. The survey also consisted of a review of the agency's implementation of the New York State Department of Health (NYS DOH) Guidance as it pertains to COVID-19, of policies and procedures, records of infection of infection control training, and the agency's staffing plan for COVID-19 positive or suspected patients. The agency reported five (5) patients with COVID-19. The Executive Director, Regional Director, Clinical Managers, and staff were interviewed. Findings were reviewed at the exit conference on 11/10/2021. The home health agency census was 1,037. The following deficiencies are identified as a result of the survey: G-0440, G-0520, G-0536, G-0574, G-0576, G-0578, G-0610, G-0984, J-1260, J-1412, J-1512, J-1428, J-1440, and J-1456.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on review of the agency's Outcome Assessment Information Set (OASIS) submissions, clinical records, and interviews with agency staff, for one (1) of seventeen (17) patients (Patient #13), the agency failed to ensure the OASIS data accurately reflects the patient's status at the time of the assessment. Failure to ensure accurate documentation of OASIS data has the potential for negative outcomes. Findings are: Patient #13 – This 52-year-old patient with diagnoses that include pneumonitis, adjustment and management of vascular access device and atherosclerotic heart disease was admitted to the home care agency on 09/30/2021. Review of the physician referral dated 09/23/2021 revealed the patient has a vascular access device (VAD) and requires assistance with VAD catheter care. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Visit Note Report dated 09/30/2021 revealed the RN documented the patient did not have a pressure ulcer, stasis ulcer or surgical wound and the integumentary assessment identified no issues. Review of the Client Coordination Note dated 09/30/2021 revealed the RN documented the patient was admitted for intravenous port care, the VAD currently had a huber needle access and dressing in place that the patient reported had been last changed on 09/29/2021. The agency failed to ensure the RN OASIS accurately reflected the patient's status at the time of the assessment. During interview on 10/15/2021 at 09:45 AM, the RN stated the VAD was a surgical wound and she documented incorrectly in her OASIS assessment.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on clinical record review and staff interview, agency staff did not inform five (5) of seventeen (17) patients (Patient #'s: 2, 7, 13, 15, and 16) of the extent of insurance coverage for various services available through home care. Failure to inform a patient about current fees for services violates patients' rights. Patient #13 – This 52-year-old patient with diagnoses that include pneumonitis, adjustment and management of vascular access device and atherosclerotic heart disease was admitted to the home care agency on 09/30/2021. Review of the A&A Form dated 09/30/2021 revealed the following regarding the Skilled Nursing services copay or deductibles: left blank. Review of the clinical record lacked documented evidence the patient was informed of the extent of insurance coverage. During interview on 10/15/2021 at 09:30 AM, the RN stated she was unaware she was required to fill in the copay or deductible on the identified form. Patient #16 – This 61-year-old patient with diagnoses that include idiopathic normal pressure hydrocephalus, unspecified lumbar vertebra fracture and unspecified thoracic vertebra fracture was admitted to the home care agency on 09/27/2021. Review of the A&A Form dated 09/27/2021 revealed the following regarding the Skilled Nursing services copay or deductibles: left blank. Review of the clinical record lacked documented evidence the patient was informed of the extent of insurance coverage. During interview on 10/15/2021 at 11:17 AM, Executive Director stated it was expected that all patients be notified verbally and in writing of financial coverage and the form had not been completed correctly by the RN. Patient #2 – This 65-year-old patient with diagnoses that include aftercare following joint replacement, intervertebral disc degeneration, and lumbosacral region was admitted to the home care agency on 07/03/2021. Review of the Authorization and Acknowledgement (A&A) Form (financial liability form) dated 07/03/2021 revealed the following: copay or deductibles: left blank. Review of the clinical record lacked documented evidence the patient was informed of the extent of insurance coverage. During interview on 10/15/2021 at 03:55 PM, the RN stated the patient does not have a copay or deductible, but she left that part blank. Patient #7 – This 78-year-old patient with diagnoses that include pressure ulcer of the sacral region, stage 3, pressure ulcer of right heel, unstageable, and dementia with lewy bodies was admitted to the home care agency on 10/01/2019. Review of the A&A Form dated 10/01/2019 revealed the following: copay or deductibles: left blank. Review of the clinical record lacked documented evidence the patient was informed of the extent of insurance coverage. During interview on 10/15/2021 at 11:42 AM, the Executive Director stated the form should be fully completed but this one was left blank. Patient #15 – This 75-year-old patient with the diagnosis idiopathic acute pancreatitis without necrosis or infection was admitted to the home care agency on 09/28/2021. Review of the A&A Form dated 09/28/2021 revealed the following: copay or deductibles: left blank. Review of the clinical record lacked documented evidence the patient was informed of the extent of insurance coverage. During interview on 10/15/2021 at 09:18 AM, the RN stated the patient did not have a copay, but she failed to document a zero.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policy and procedure and staff interview for one (1) of seventeen (17) patients (Patient #16), the agency failed to ensure the Registered Nurse (RN) conducted an initial assessment of the patient within forty-eight (48) hours of referral, the patient's return home, or on the physician-ordered start of care date. Failure to conduct the initial assessment within the required time frame has the potential to result in unmet patient needs and negative patient outcomes. Findings are: Review of the agency policy entitled “Assessment For CHHA (Certified Home Health Agency)” revised 02/2014 revealed “the initial patient assessment shall be made by a RN/Therapist within 24 (twenty-four) hours of receipt and acceptance of a community referral or return home from institutional placement, unless: - The patient’s authorized practitioner orders otherwise; or - There is written documentation that the patient or family/caregiver refuses such a visit.” Patient #16 – This 61-year-old patient with diagnoses that include idiopathic normal pressure hydrocephalus, unspecified lumbar vertebra fracture and unspecified thoracic vertebra fracture was admitted to the home care agency on 09/27/2021. Review of the physician office referral dated 09/24/2021 revealed the following: - The patient was referred to home care on 09/24/2021 and the referral did not specify a start of care date. - The referral requested the following services: Nursing, Physical Therapy, Occupational Therapy and a Registered Dietician. - The agency received the referral by FAX on 09/24/2021. Review of the RN OASIS (Outcome and Assessment Information Set) Admission Visit Note Report dated 09/27/2021 revealed the initial assessment for services occurred on 09/27/2021 (greater than forty-eight hours after receipt of the referral). Review of the clinical record lacked documented evidence of a physician order to delay the start of care until 09/27/2021. During interview on 10/15/2021 at 10:43, the Clinical Nurse Manager stated the physician was not notified of the delay in starting home care services and should have been.

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 review of clinical records and interviews with staff, for two (2) of seventeen (17) patients (Patient #s: 4 and 16), the agency failed to ensure that a comprehensive assessment consistent with the patient's needs was performed within five (5) calendar days after the Start of Care (SOC). The issues are: - Physical Therapy (PT) failed to complete a comprehensive assessment within five (5) days of the SOC (Patient #s: 4). - Occupational Therapy (OT) failed to complete a comprehensive assessment within five (5) days of the SOC (Patient #16). Failure to ensure a comprehensive assessment is complete and accurate has the potential for unmet patient needs and possible negative outcomes. Findings are: Patient #16 – This 61-year-old patient with diagnoses that include idiopathic normal pressure hydrocephalus, unspecified lumbar vertebra fracture and unspecified thoracic vertebra fracture was admitted to the home care agency on 09/27/2021. Review of the physician office referral dated 09/24/2021 revealed the agency was requested to provide the following services: Nursing, Physical Therapy, Occupational Therapy and a Registered Dietician. Review of the Home Health Certification and Plan of Care for the certification period from 09/27/2021 to 11/25/2021 revealed an order for OT to conduct one visit the week of 10/10/2021 (thirteen days after the start of care). Review of the Client Coordination Note dated 10/04/2021 (seven days after the start of care) revealed the patient notified the agency on 10/04/2021 that she would be staying with family out of town for the week and requested to resume home care services the following week. Review of the clinical record lacked documented evidence of OT attempts to evaluate the client within five (5) days of the start of care visit and physician notification of the delay for the OT evaluation. The agency failed to ensure that a comprehensive assessment consistent with the patient's needs was performed within five (5) calendar days after the SOC. During interview on 10/15/2021 at 11:15 AM, the OT stated she was assigned the patient evaluation but was out on maternity leave until 10/11/2021. Patient #4 – This 91-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic diastolic (congestive) heart failure, and sick sinus syndrome was admitted to the home care agency on 09/10/2021. Review of the referral to the home care agency dated 09/08/2021 revealed the patient was referred to the agency for acute diastolic heart failure/weakness monitoring and PT evaluation. Review of the Home Health Certification and Plan of Care for certification period 09/10/2021 to 11/08/2021 revealed the order for PT to conduct one visit the week of 09/19/2021 (nine (9) days after the start of care). Review of the clinical record from 09/10/2021 to 10/12/2021 (date of survey) lacked documented evidence the physician was contacted regarding the delay in the PT evaluation, or a reason why it was delayed. The agency failed to ensure that a comprehensive assessment consistent with the patient's needs was performed within five (5) calendar days after the SOC. During interview on 10/15/2021 at 01:28 PM, the Clinical Nurse Manager stated there were no PT available until the week of 09/19/2021.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on review of clinical records and interview with agency staff for three (3)) of seventeen (17) patients (Patient #'s: 9,12 and 13), the agency failed to ensure the comprehensive assessment is consistent and accurately reflects the patient's status and needs. The issues are: - The Registered Nurse (RN) failed to assess the patient’s ability to administer aerosolized (in the form of a fine spray) medications ordered (Patient #9). - The RN failed to assess the patient’s blood glucose (Patient #’s 9,12 and 13). - The RN failed to assess the patient’s arteriovenous (AV) fistula (Patient #12). Failure to ensure comprehensive assessments accurately reflect the patient status and needs has the potential for unmet patient needs and the potential for negative patient outcomes. Findings are: Patient #9 – This 60-year-old patient with diagnoses that include type II diabetes mellitus, essential hypertension and chronic obstructive pulmonary disease was admitted to the home care agency on 09/30/2021. A.) Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed orders for instruction/reinforcement of diabetes management including: diet, skin care, foot care, diabetic medications and patient/caregiver blood glucose testing before each meal. There is an order for the physician to be notified of a FBS (fasting blood sugar) less than 70 or greater than 300. Review of the RN OASIS (Outcome and Assessment Information Set) Admission Visit Note Report dated 09/30/2021 revealed the RN observed the patient with demonstration of blood sugar testing but failed to document the patient’s blood sugar obtained during the assessment. The RN failed to assess the patient’s blood glucose. During interview on 10/15/2021 at 12:13 PM, the RN stated she mistakenly did not document the blood sugar obtained on her assessment. B.) Review of the Home Health Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed medication orders for: - Albuterol to be administered via nebulizer (machine that delivers medication in mist form into lungs) as needed for shortness of breath; - Fluticasone nasal spray daily; - Proair inhaler as needed for shortness of breath; and - Symbicort inhaler twice daily. Review of the RN OASIS (Outcome and Assessment Information Set) Admission Visit Note Report dated 09/30/2021 revealed the RN documented the following regarding the patient’s medication administration: - Requires mediset be filled by agency staff; - Patient takes medications from mediset; - Patient has a lack of capable caregiver for assistance; - Limited health literacy and/or medication understanding; and - Disorganized medication routine. The 09/30/2021 RN assessment lacks documented evidence of the patient being assessed for the ability to administer ordered medications by nebulizer and inhaler. The RN failed to assess the patient’s ability to administer aerosolized medications. During interview on 10/15/2021 at 12:05 PM, the RN stated the patient was able to self-administer his medications when he was not having severe shortness of breath via both the nebulizer and inhalers but failed to document this. Patient #12 – This 78-year-old patient with diagnoses that include paroxysmal atrial fibrillation, nonrheumatic aortic stenosis and end stage renal disease was admitted to the home care agency on 10/02/2021. A.) Review of the Home Health Certification and Plan of Care for the certification period from 10/02/2021 to 11/30/2021 revealed orders for Skilled Nurse for instruction/reinforcement of diabetes management including diabetic foot care and monitoring diabetic control. Skilled Nurse will assess skin integrity as needed. “Patient independent with checks. Blood Sugar checks at random.” There is also an order for the physician to be notified of FBS less than 70 or greater than 300. Review of the RN OASIS Admission Visit Note Report dated 10/02/2021 revealed the RN documented Endocrine/Hematopoietic- no issues identified and lacked documented evidence of a blood glucose being obtained or reported. The RN failed to assess the patient’s blood glucose. During interview on 10/15/2021 at 02:10 PM, the RN stated he did not obtain or record a blood glucose during the assessment and should have. B.) Review of the facility discharge summary dated 10/01/2021 revealed the patient has end stage renal disease, receives hemodialysis three times weekly and has an AV fistula/graft in place. Review of the RN OASIS Admission Visit Note Report dated 10/02/2021 lacks documented evidence of an assessment of the AV fistula. The RN failed to assess the patient’s AV fistula. During interview on 10/15/2021 at 02:05 PM, the RN stated the patient had a AV fistula in her left arm that he assessed but he made a mistake and did not include it in his assessment. Patient #13 – This 52-year-old patient with diagnoses that include pneumonitis, adjustment and management of vascular access device and atherosclerotic heart disease was admitted to the home care agency on 09/30/2021. Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed orders for Skilled Nurse for instruction/reinforcement of diabetes management including diabetic foot care and monitoring diabetic control. Skilled Nurse will assess skin integrity as needed. Patient/ Caregiver checks blood sugars independently QID (four times daily). There is also an order to notify the physician of a FBS less than 70 or greater than 300. Review of the RN OASIS Admission Visit Note Report dated 09/30/2021 lacked documented evidence of a blood sugar being obtained or reported. The RN failed to assess the patient’s blood glucose. During interview on 10/15/2021 at 09:45 AM, the RN stated the patient reported her blood sugar reading but it was not documented in the assessment.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on clinical record review and interviews with agency staff, for seven (7) of seventeen (17) clinical records (Patient #'s: 2, 5, 6, 11, 12, 13, 14, and 17) lacked documented evidence of a complete review of all medications the patient currently uses to identify any potential adverse effects, drug reactions, or concerns. The issues are: - The Registered Nurse (RN) failed to identify and reconcile all medication discrepancies identified in the referral for services and the Plan of Care (POC) (Patient #'s: 5, 6, 11, 12, 13, 14, 17). - The RN failed to include an end date for a controlled drug order (Patient #2). - The RN failed to include an end date for a short-term medication (Patient #12). - The RN failed to communicate with the physician regarding a medication on the patient's medication list that is also currently on the patient's allergy list (Patient #13). Failure to conduct a complete medication review and to ensure the medication regime is appropriate has the potential for the patient harm. Patient #17 – This 78-year-old patient with diagnoses that include hemiplegia following cerebral infarction affecting right dominant side, type II diabetic mellitus with diabetic neuropathy, and chronic combined systolic and diastolic heart failure was admitted to the home care agency on 09/28/2021. A.) Review of the Continuity of Care Document dated 09/24/2021 (referral to the home care agency) revealed the order for Pantoprazole Sodium (Protonix) 40 mg (milligrams) 1 tablet by mouth twice a day. Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 revealed the order for Protonix 40 mg (milligrams) 1 tablet by mouth daily. Review of the clinical record lacked documented evidence that the physician was contacted regarding the discrepancies during medication reconciliation. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/15/2021 at 02:42 PM, the RN stated the patient takes the mediation differently than what was prescribed. She did contact the physician but did not clearly document it in the record. B.) Review of the Continuity of Care Document dated 09/24/2021 (referral to the home care agency) revealed the following orders: - Flonase allergy relief 50 mcg (micrograms)/actuation 2 spray each nostril once daily - Diabetic Tussin 100 mg/5 ml (milligrams per milliliter) 5 – 10 ml four times a day as needed - Sucralfate 1 gm (gram) tablets in the morning and at bedtime Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 lacks orders for Flonase, Diabetic Tussin, and Sucralfate. Review of the clinical record lacked documented evidence that the physician was contacted regarding the discrepancies during medication reconciliation. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/15/2021 at 02:42 PM, the RN stated the patient chooses to no longer take these medications. She did contact the physician but did not clearly document it in the record. C.) Review of the Continuity of Care Document dated 09/24/2021 (referral to the home care agency) revealed the following orders: - Diclofenac Sodium four times as needed - Hydroxyzine HCL (Hydrochloride) 10 mg (milligram) tablet once by mouth at night - Basaglar Kwikpen 100 unit/ml (milliliters) pen-inject use 25 units under skin once daily Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 revealed the following orders: - Diclofenac 1% topical gel 2 times a day as needed apply thin layer to ribs as needed for pain - Hydroxyzine HCL (hydrochloride) 25 mg (milligram) tablet once by mouth at bedtime - Basaglar Kwikpen U-100 insulin 100 unit/ml (milliliters) subcutaneous 30 units daily Review of the clinical record lacked documented evidence that the physician was contacted regarding the discrepancies during medication reconciliation. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/15/2021 at 02:45 PM, the RN stated the patient chooses to take the medications differently than what was ordered. The RN did contact the physician but did not clearly document it in the record. D.) Review of the Continuity of Care Document dated 09/24/2021 (referral to the home care agency) revealed the following orders: - Cholestyramine 4 gm (grams) packet mix the contents of 1 packet in liquid and drink daily - medical compression stockings on the in morning, off in the evening - splint wrist brace, right splint for tendinitis wrist Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 lacks orders for Cholestyramine, compression stockings, and a wrist splint. Review of the clinical record lacked documented evidence that the physician was contacted regarding the discrepancies during medication/durable medical equipment reconciliation. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/15/2021 at 02:51 PM, the RN stated the patient does use the medication and durable medical equipment from the referral, but orders were not obtained, it was missed. E.) Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 revealed the orders for the following: - Gemtesa 75 mg (milligrams) tablet by mouth at bedtime - Probiotic 10 billion cell capsule, delayed release one capsule by mouth daily Review of the Continuity of Care Document dated 09/24/2021 (referral to the home care agency) lacks orders for Gemtesa and the probiotic. Review of the clinical record lacked documented evidence that the physician was contacted regarding the discrepancies during medication reconciliation. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/15/2021 at 02:51 PM, the RN stated these medications were in the home and orders were obtained, however she did not document her conversation with the physician regarding the addition of these medications. Patient #14 – This 76-year-old patient with diagnoses that include urinary tract infection, acute kidney failure, and type II diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 10/01/2021. A.) Review of the Discharge Summary dated 09/27/2021 (referral to home care agency) revealed the patient is ordered the following: - Nystatin ointment - CPAP (continuous positive airway pressure) machine to operate at bedtime – 5 cm H20 (settings), duration: lifetime - Wrist brace to wear on right wrist Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 lacks orders for Nystatin, a CPAP machine, and a wrist brace. Review of the clinical record lacked documented evidence that the physician was contacted regarding the discrepancies during medication/durable medical equipment reconciliation. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/15/2021 at 09:15 AM, the RN stated she did not clarify the nystatin or CPAP orders with the physician. She did not remember the patient having a wrist brace and did not notice it was on the discharge paperwork. B.) Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 revealed the patient is ordered to take the following medications: - Allopurinol 100 mg (milligrams) tablet by mouth daily - Meclizine 12.5 mg tablet by mouth every eight (8) hours as needed Review of the Discharge Summary dated 09/27/2021 (referral to home care agency) lacks orders for Allopurinol and Meclizine. Review of the clinical record lacked documented evidence that the physician was contacted regarding the discrepancies during medication reconciliation. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/15/2021 at 09:15 AM, the RN stated she spoke with the physician regarding the medications but did not document it in the record. Patient #2 – This 65-year-old patient with diagnoses that include aftercare following joint replacement, intervertebral disc degeneration, and lumbosacral region was admitted to the home care agency on 07/03/2021. Review of the discharge summary dated 07/01/2021 revealed the order for Oxycodone 5 mg oral immediate release tablet take 1 (one) by mouth every 4 (four) hours as needed for pain for up to 7 (seven) days. Review of the Home Health Certification and Plan of Care for certification period 07/03/2021 to 08/31/2021 revealed the order Oxycodone 5 mg tablet by mouth every 4 (four) hours as needed for pain. The RN failed to include an end date for a controlled drug order. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/15/2021 at 01:22 PM, the RN stated there should be an end date on the order, but she failed to document one. Patient #6 – This 51-year-old patient with diagnoses that include fracture of upper end of right humerus, asthma, and anxiety disorder was admitted to the home care agency on 10/01/2021. Review of the referral to home care dated 09/30/2021 revealed the patient is ordered to take the following medications: - Lidocaine 5% (percent) ointment use a small amount on vulva and vestibule twice daily as needed for pain - Lidocaine 1% solution injection self-instill 20 ml (milliliters) into bladder daily PRN (as needed) Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 lacks orders for the Lidocaine ointment and solution. Review of the clinical record lacked documented evidence that the physician was contacted regarding the discrepancies during medication reconciliation. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/15/2021 at 01:31 PM, the RN stated she did follow-up with the physician regarding the medications but did not document that. Patient #13 – This 52-year-old patient with diagnoses that include pneumonitis, adjustment and management of vascular access device and atherosclerotic heart disease was admitted to the home care agency on 09/30/2021. A.) Review of the physician referral dated 09/23/2021 revealed the patient was currently taking the following medications: - Nystatin ointment apply to the angles of the mouth two times daily; - Insulin lispro (100 unit/ml injection pen, inject into the skin 3 (three) times daily (before meals) subcutaneous; - Insulin aspart 100 unit/ ml inject into the skin 3 (three) times daily (before meals) maximum ***units/day (the dose of insulin was not specified). Review of the Home Health Certification and Plan of Care for the certification period from 09/302021 to 11/28/2021 lacks orders for Nystatin, insulin lispro and insulin aspart. Review of the clinical record lacks documented evidence that the physician was contacted regarding the discrepancies identified between the referral and POC. During interview on 10/15/2021 at 09:28 AM, the RN stated the patient was taking Nystatin but she failed to add it to the POC. The RN also stated the patient was not taking either lispro or aspart insulin and she failed to address this with the physician. B.) Review of the physician referral dated 09/23/2021 revealed the patient was currently taking the medication Alteplase, 1 mg (milligram)/ ml (milliliter) 0.5- 2 mg by intracatheter route once. Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed the order Alteplase 1mg/ ml instill 2 mg intravenous as directed/ prn (as needed) every 3 (three) months. Review of the clinical record lacks documented evidence that the physician was contacted regarding the discrepancy identified between the referral and POC. During interview on 10/15/2021 at 09:33 AM, the RN stated she wrote the order incorrectly on the POC as it was administered every three months and she did not communicate the medication discrepancy with the physician. C.) Review of the physician referral dated 09/23/2021 revealed the patient had the following allergies: Latex, Amoxicillin, Celecoxib, Demerol, Doxycycline Hyclate, Erythromycin, Mercaptopurine, Metoclopramide, Metoclopramide HCL, Midazolam HCL, Prednisone, Pregabalin, Promethazine, Sulfa Antibiotics, Tetracycline, mango, Barium Sulfate, Metronidazole, Nuvigil, Ofloxacin, Penicillins, Vancomycin, blueberry, Budesonide, contrast dye, Doxycycline, Fluticasone- Salmeterol, Gentamicin, Gentamicin Sulfate, Ondansetron, Triamcinolone Hexacetonide, Solriamfetol, COVID-19 Vaccine, adhesives and iodinated contrast media. Review of the physician referral dated 09/23/2021 revealed the patient was currently taking the following medications: - Metronidazole 0.75% 45 g (gram) apply topically daily to face; and - Ondansetrom 4 mg disintegrating tablet take 1 (one) tablet by mouth 3 (three) times daily as needed for vomiting, place on top of tongue. Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed the patient had the following allergies: Mercaptopurine, adhesives, Amoxicillin, Barium, blueberries, Budesonide, Celecoxib, contrast dye, Demerol, Doxycycline, Erythromycin, Fluticasone-Salmeterol, Gentamicin, iodinated diagnostic agents, Latex, mango, Metocloperamide, Metronidazole, Midazolam, Nuvigil, Ofloxacin, Ondansetron, Penicillins, Prednisone, Pregabalin, Promethazine. Sulfa antibiotics, sulfate, Tetracycline, Triamcinolone Hexacetonide and Vancomycin. Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed the following medication orders: - Metronidazole 0.75% lotion apply topically daily; - Ondansetron 4 mg disintegrating tablet oral 3 (three) times daily/ prn, as needed for nausea; and - Ondansetron HCL (PF) 4 mg/ 2 ml injection solution 4 (four) times daily/ PRN as needed for nausea. Review of the clinical record lacks documented evidence the physician was contacted regarding the allergies to Metronidazole and Ondansetron and the patient taking Metronidazole and Ondansetron. During interview on 10/13/2021 at 03:45 PM, the Clinical Nurse Manager stated she would follow-up and confirm the physician was notified and agreeable to the patient taking the Metronidazole and Ondansetron. On 10/14/2021 at 12:00 PM the agency provided a Client Coordination Note dated 10/13/2021 that revealed the RN spoke with the physician on 10/13/2021 and confirmed the patient could continue to take Ondansetron and Metronidazole as the patient had low severity reactions to both identified allergies. During interview on 10/15/2021 at 09:23 AM, the RN stated during the medication reconciliation, the patient reported she had only mild reactions to both identified medications. The RN stated she left a message for the physicians office but did not document this specifically and the physician did not call her back with any concerns. Patient #11 – This 60-year-old patient with diagnoses that include osteoarthritis, right shoulder complete rotator cuff tear and type II diabetes mellitus was admitted to the home care agency on 10/01/2021. A.) Review of the After Visit Summary for the hospitalization from 09/09/2021 to 09/13/2021 included in the physician referral dated 09/30/2021 revealed the patient is to stop taking Ibuprofen 800 mg. Review of the Home Health Certification and Plan of Care for the certification period from 10/01/2021 to 11/29/2021 revealed an order for Ibuprofen 800 mg oral tablet 3 (three) times daily/ PRN as needed for pain. Review of the clinical record lacks documented evidence that the physician was contacted regarding the discrepancy identified between the referral and POC. During interview on 10/15/2021 at 08:55 AM, the RN stated she did not follow up with the physician regarding the identified issue. B.) Review of the After Visit Summary for the hospitalization from 09/09/2021 to 09/13/2021 included in the physician referral dated 09/30/2021 revealed the patient is to take Acetaminophen Extra Strength 500 mg take 2 (two) tablets (1,000 mg) by mouth 3 (three) times daily. Review of the Home Health Certification and Plan of Care for the certification period from 10/01/2021 to 11/29/2021 revealed the order Acetaminophen Extra Strength 500 mg oral tablet, take 1 (one) tablet every 6 (six) hours/PRN as needed for pain. Review of the clinical record lacks documented evidence that the physician was contacted regarding the discrepancy identified between the referral and POC. During interview on 10/15/2021 at 08:57 AM, the RN stated she did not follow-up with the physician regarding the discrepancy. C.) Review of the Home Health Certification and Plan of Care for the certification period from 10/01/2021 to 11/29/2021 revealed medication orders for: - Sertraline 100 mg oral tablet, 1.5 tablets daily; and - Vitamin D3 25 mcg (micrograms) (1,000 unit) oral tablet 1 (one) tablet daily. Review of the After Visit Summary for the hospitalization from 09/09/2021 to 09/13/2021 included in the physician referral dated 09/30/2021 lacks orders for Sertraline and Vitamin D3. Review of the clinical record lacks documented evidence that the physician was contacted regarding the discrepancy identified between the referral and POC. During interview on 10/15/2021 at 09:05 AM, the RN stated she verified the identified medications by the bottles in the home but did not document it. Patient #12 – This 78-year-old patient with diagnoses that include paroxysmal atrial fibrillation, nonrheumatic aortic stenosis and end stage renal disease was admitted to the home care agency on 10/02/2021. A.) Review of the facility discharge summary dated 10/01/2021 revealed the patient was discharged on Metoprolol 100 mg oral tablet 2 (two) times daily. Review of the Home Health Certification and Plan of Care for the certification period from 10/02/2021 to 11/30/2021 revealed the medication order for Metoprolol 100 mg, extended release, oral, take 1 (one) tablet by mouth daily. Review of the clinical record lacks documented evidence that the physician was contacted regarding the discrepancy identified between the referral and POC. During interview on 10/15/2021 at 01:55 PM, the RN stated he made a mistake and the patient was supposed to take the med twice daily. B.) Review of the facility discharge summary dated 10/01/2021 revealed the patient was discharged on Aspirin 81 mg tablet oral daily and the Aspirin was to be stopped on 10/08/2021. Review of the Home Health Certification and Plan of Care for the certification period from 10/02/2021 to 11/30/2021 revealed the medication order for Aspirin Childrens 81 mg chewable tablet take 1 (one) tab by mouth daily (there is no end date for this order). Review of the clinical record lacks documented evidence that the physician was contacted regarding the discrepancy identified between the referral and POC. During interview on 10/15/2021 at 02:00 PM, the RN stated he made a mistake and left out the end date on the order. Patient #5 – This 76-year-old patient with diagnoses that include thoracic vertebra fracture T11- T12, paraplegia and urinary tract infection was admitted to the home care agency on 08/04/2021. Review of the Facility To Field Info (Information) Form dated 08/03/2021 revealed the patient was discharged from a rehabilitation facility on 08/03/2021. The form also specified the following regarding the patient’s congestive heart failure, “Furosemide dose has been adjusted due to fluctuating renal function. Discharged home on 20 mg daily. (Dose) decreased on 08/02/2021.” Review of the Home Health Certification and Plan of Care for the certification period from 08/04/2021 to 10/02/2021 revealed the medication order for Furosemide 40 mg oral tablet, 1 (one) tablet daily. Review of the clinical record lacks documented evidence that the physician was contacted regarding the discrepancy identified between the referral and POC. During interview on 10/15/2021 at 03:03 PM, the RN stated she did not document following-up with the physician regarding the discrepancy and cannot recall the visit as it occurred in August.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interviews for eleven (11) of seventeen (17) patients (Patient #'s: 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, and 16) the agency failed to ensure a comprehensive Plan of Care (POC), based on clinical assessments, was developed to meet the individualized needs of the patients. The issues are: - The POC lacks indicators for PRN (as needed) medications (Patient #’s: 5, 6, 7, 8, 11, 14 and 16). - The POC lacks an order for blood glucose testing (Patient #8). - The POC lacks parameters for blood glucose testing (Patient #8). - The POC lacks an order for leg braces (Patient #8). - The POC lacks an order for bleeding precautions for a patient on a blood-thinning agent (Patient #’s 6 and 12). - The POC lacks a route for oxygen use (Patient #’s: 7 and 14). - The POC lists a duplicate order (Patient #14). - The POC lacks all pertinent diagnoses (Patient #’s 10 and 15). - The POC lacks instruction for where to place a topical medication (Patient #15). - The POC lacks an order for a nebulizer (Patient #’s 9 and 12). - The POC lacks an order for obtaining weights (Patient #12). - The POC lacks an order for Telehealth monitoring (Patient #5). Failure to ensure the POC is comprehensive to meet the patient's needs has the potential for staff to provide inappropriate care. Patient #8 – This therapy-only 81-year-old patient with diagnoses that include diffuse large B-cell lymphoma, hypothyroidism, and type II diabetes mellitus with diabetic neuropathy was admitted to the home care agency on 09/20/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 09/20/2021 to 11/18/2021 revealed the order “Naprelan CR 375 mg tablet extended release 24 hours daily as needed/prn max daily dose is 2 (two) tabs (tablets).” The POC lacks an indicator for a PRN (as needed) medication. During interview on 10/14/2021 at 03:15 PM, the PT (Physical Therapy) Clinical Manager stated she did not document an indicator for the medication. Review of the Home Health Certification and Plan of Care for certification period 09/20/2021 to 11/18/2021 revealed “the patient/caregiver ensures diabetes management via BG (blood glucose) checks.” B.) Review of the Home Health Certification and Plan of Care for certification period 09/20/2021 to 11/18/2021 lacks documented evidence of an order for blood glucose testing. The POC lacks an order for blood glucose testing. C.) Review of the Home Health Certification and Plan of Care for certification period 09/20/2021 to 11/18/2021 lacks documented evidence of parameters for blood glucose testing. The POC lacks parameters for blood glucose testing. During interview on 10/14/2021 at 03:20 PM the PT Clinical Manager stated she failed to write an order with parameters for the patient’s daily blood glucose checks. D.) On 10/12/2021 the surveyor conducted a home visit. During the visit, the patient was wearing leg braces. Review of the Home Health Certification and Plan of Care for certification period 09/20/2021 to 11/18/2021 lacks an order for leg braces to include who is responsible and frequency for use. The POC lacks an order for leg braces. During interview on 10/14/2021 at 03:20 PM the PT Clinical Manager stated the patient did have those leg braces at the start of care, but she forgot to include them on the POC. Patient #14 – This 76-year-old patient with diagnoses that include urinary tract infection, acute kidney failure, and type II diabetes mellitus with diabetic chronic kidney disease was admitted to the home care agency on 10/01/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 revealed the order for oxygen at 2 (two) liters continuous. Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 lacks a route for oxygen administration. The POC lacks a route for oxygen administration. During interview on 10/15/2021 at 09:12 AM, the RN stated she did not include a route on the order for oxygen. B.) Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 revealed the orders for the following medications: - Acetaminophen extra strength 500 mg tablet every 6 (six) hours as needed - Albuterol Sulfate HFA 90 mcg (micrograms)/actuation aerosol inhaler every 4 (four) hours as needed - Meclizine 12.5 mg tablet every 8 (eight) hours as needed Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 lacks indications for use for the medications. The POC lacks indications for use for PRN (as needed) medication. During interview on 10/15/2021 at 09:13 AM, the RN stated she did not document reasons for use for the PRN medications. C.) Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 revealed the following duplicate orders for melatonin: - Melatonin 3 mg tablet by mouth at bedtime as needed - Melatonin 3 mg tablet by mouth at bedtime/PRN (as need) for insomnia The RN failed to identify a duplicate order on the POC. The RN failed to identify and reconcile all medication discrepancies identified in the referral for services and the POC. During interview on 10/15/2021 at 09:15 AM, the RN stated the duplication is an error. Patient #6 – This 51-year-old patient with diagnoses that include fracture of upper end of right humerus, asthma, and anxiety disorder was admitted to the home care agency on 10/01/2021. A.) Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 revealed the order for warfarin (blood-thinning agent) 5 mg tablet daily. Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 lacks documented evidence the patient is on bleeding precautions. The POC lacks an order for bleeding precautions for a patient on a blood-thinning agent. During interview on 10/15/2021 at 01:31 PM, the RN stated the patient should be ordered bleeding precautions, but she left it off the POC in error. B.) Review of the Home Health Certification and Plan of Care for certification period 10/01/2021 to 11/29/2021 revealed the following orders: - Bisacodyl 10 mg rectal suppository daily as needed/prn (as needed) - Dihydroergotamine 0.5 mg/pump act (actuation) (4mg/ml) nasal spray as directed/prn no more than 4 sprays in 1 (one) hour limit 2 (two) days a week - Fentanyl 12mcg/hr (microgram per hour) transdermal patch as directed/prn every 48 (forty-eight) hours - Gaviscon 95 mg – 358 mg/15 ml oral suspension daily as needed/prn The POC lacks indicators for PRN (as needed) medication. During interview on 10/15/2021 at 01:32 PM, the RN stated she did not include indicators for use on the medication orders. Patient #7 – This 78-year-old patient with diagnoses that include pressure ulcer of the sacral region, stage 3, pressure ulcer of right heel, unstageable, and dementia with lewy bodies was admitted to the home care agency on 10/01/2019. A.) Review of the Home Health Certification and Plan of Care for certification period 09/20/2021 to 11/18/2021 revealed the following orders: - Metamucil (sugar) oral powder 17 grams daily as needed - Oxazepam 10 mg (milligrams) capsule 3 times daily/prn (as needed) - Tussin 100mg/5 ml (milliliters) oral liquid 2 times daily/prn - Tylenol 325 mg capsule 2 (two) times daily/prn The POC lacks indicators for PRN (as needed) medications. During interview on 10/15/2021 at 12:45 PM, the RN stated she did not include indicators for use on the medication orders. B.) Review of the Home Health Certification and Plan of Care for certification period 09/20/2021 to 11/18/2021 revealed the order “oxygen 2 liters prn (as needed) for shortness of breath, low oxygen levels.” The POC lacks a route for oxygen use. During interview on 10/15/2021 at 12:47 PM, the RN stated she did not include a route in the order. Patient #15 – This 75-year-old patient with the diagnosis idiopathic acute pancreatitis without necrosis or infection was admitted to the home care agency on 09/28/2021. A.) Review of the RN OASIS (Outcomes and Assessment Information Set) dated 09/28/2021 revealed the RN documented the patient has hypertension and hypothyroidism. Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 revealed the patient is taking Amlodipine (treats hypertension) and Levothyroxine (treats hypothyroidism). Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 revealed the diagnosis idiopathic acute pancreatitis without necrosis or infection. The POC lacks all pertinent diagnoses. During interview on 10/15/2021 at 09:18 AM, the RN stated she documented the diagnoses that were on the referral. The office staff are to add the other diagnoses and send back to her for approval. The other pertinent diagnoses were not added to the POC in error. B.) Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 revealed the order for Lidocaine 5% (percent) topical patch daily. The POC lacks instruction for where to place a topical medication. During interview on 10/15/2021 at 09:20 AM, the RN stated she did not document instructions on where to put the lidocaine patch. Patient #10 – This 94-year-old patient with diagnoses that include acute embolism and thrombosis deep veins of left lower extremity, pressure-induced deep tissue damage of right heel, and urinary tract infection was admitted to the home care agency on 09/28/2021. Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 revealed the order “SN (Skilled Nurse) to perform wound care to stage II pressure injury to sacral until healed… change 2 times weekly.” Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 lacks a diagnosis for the stage II pressure ulcer at the sacrum. The POC lacks all pertinent diagnoses. During interview on 10/18/2021 at 11:33 AM, the Regional Director stated the diagnosis is not listed on the POC. Findings are: Patient #12 – This 78-year-old patient with diagnoses that include paroxysmal atrial fibrillation, nonrheumatic aortic stenosis and end stage renal disease was admitted to the home care agency on 10/02/2021. A.) Review of the Home Health Certification and Plan of Care for the certification period from 10/02/2021 to 11/30/2021 revealed medication orders for: - Clopidogrel (blood-thinning agent) 75 mg tablet take 1 (one) tab by mouth daily; and - Eliquis (blood-thinning agent) 2.5 mg tablet take 1 (one) tab by mouth 2 (two) times daily. Review of the Home Health Certification and Plan of Care for certification period from 10/02/2021 to 11/30/2021 lacks documented evidence the patient is on bleeding precautions. The POC lacks an order for bleeding precautions for a patient on blood-thinning agents. During interview on 10/15/2021 at 02:04 PM, the RN stated he mistakenly left off bleeding precautions on the POC. B.) Review of the Home Health Certification and Plan of Care for the certification period from 10/02/2021 to 11/30/2021 revealed a medication order for Albuterol Sulfate 2.5 mg/3 ml (0.083%) solution, take 3 (three) ml’s by nebulization every 6 (six) hours as needed for wheezing. Review of the Home Health Certification and Plan of Care for the certification period from 10/02/2021 to 11/30/2021 lacks an order for a nebulizer machine. The POC lacks an order for a nebulizer. During interview on 10/15/2021 at 02:15 PM, the RN stated he mistakenly left the nebulizer off the POC. C.) Review of the Home Health Certification and Plan of Care for the certification period from 10/02/2021 to 11/30/2021 revealed the following: - Diagnoses of congestive heart failure and end stage renal disease; - An order for Telehealth (remote monitoring system) effective 10/03/2021; and - Identification of an increased risk of hospitalization due to diagnoses that include congestive heart failure and chronic obstructive pulmonary disease. Review of the Home Health Certification and Plan of Care for the certification period from 10/02/2021 to 11/30/2021 lacks an order for obtaining weights. During interview on 10/15/2021 at 10:03 AM, the RN stated a weight order with parameters to call the physician for should have been on the POC and was left off by mistake. Patient #5 – This 76-year-old patient with diagnoses that include thoracic vertebra fracture T11- T12, paraplegia and urinary tract infection was admitted to the home care agency on 08/04/2021. Review of the Home Health Certification and Plan of Care for the certification period from 08/04/2021 to 10/02/2021 revealed a medication order for Senna- S 8.6 mg- 50 mg oral tablet 2 (two) tablets daily as needed/ PRN. The POC lacks the as needed/PRN indicator for the medication. During interview on 10/15/2021 at 02:55 PM, the RN stated she made a mistake and left the indicator off the order. B.) Review of the Coordination Note dated 08/04/2021 revealed the RN documented the patient already had telehealth set up in the home at the time of the start of care. Review of the Home Health Certification and Plan of Care for the certification period from 08/04/2021 to 10/02/2021 lacks an order for Telehealth monitoring. The POC lacks an order for Telehealth. During interview on 10/15/2021 at 03:05 PM, the Clinical Nurse Manager stated the patient had been active with the agency receiving Telehealth prior to his admission on 08/04/2021. She stated when the RN admitted the patient on 08/04/2021 she should have obtained another order for Telehealth and did not. Patient #9 – This 60-year-old patient with diagnoses that include type II diabetes mellitus, essential hypertension and chronic obstructive pulmonary disease was admitted to the home care agency on 09/30/2021. Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed a medication order for Albuterol Sulfate 2.5 mg/3 ml (0.083%) solution, 1 (one) vial by nebulizer every 4 (four) hours as needed for shortness of breath or wheezing. Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 lacks an order for a nebulizer machine. The POC lacks an order for a nebulizer. During interview on 10/15/2021 at 12:00 PM, the RN stated she should have included the nebulizer on the POC. Patient #11 – This 60-year-old patient with diagnoses that include osteoarthritis, right shoulder complete rotator cuff tear and type II diabetes mellitus was admitted to the home care agency on 10/01/2021. Review of the Home Health Certification and Plan of Care for the certification period from 10/01/2021 to 11/29/2021 revealed a medication order for Oxycodone 5 mg tablet oral, 0.5-2 tablets every 4 (four) hours as needed/PRN. The POC lacks the as needed/PRN indicator for the medication. During interview on 10/15/2021 at 09:03 AM, the RN stated she forgot to add the PRN qualifier to the med order. Patient #16 – This 61-year-old patient with diagnoses that include idiopathic normal pressure hydrocephalus, unspecified lumbar vertebra fracture and unspecified thoracic vertebra fracture was admitted to the home care agency on 09/27/2021. Review of the Home Health Certification and Plan of Care for the certification period from 09/27/2021 to 11/25/2021 revealed medication orders for: - Acetaminophen 300 mg- Codeine 30 mg tablet, 1 (one) tablet 3 (three) times a day as needed/PRN. - Colace 100 mg capsule- 1 (one) capsule daily as needed/PRN. - Ondansetron 4 mg disintegrating tablet, 1 (one) tablet every 6 (six) hours as needed/PRN. The POC lacks the as needed/PRN indicators for the medications. During interview on 10/13/2021 at 09:25 AM, the RN stated she thought if she put the PRN indicators on the Medication Record it would carry over onto the POC.

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 clinical record review and staff interview, three (3) of seventeen (17) patient records (Patient #’s: 4, 5, and 10) lacked evidence an order was obtained to update the Plan of Care (POC) to reflect the patient's status. The issues are: - The Registered Nurse (RN) failed to obtain an order for compression stockings (Patient #’s 4 and 5). - The RN failed to obtain an order for a foley catheter (Patient #10). Failure to obtain an order to update the POC has the potential for agency staff to act on inaccurate and incomplete information, and places patient health and welfare at risk. Patient #5 – This 76-year-old patient with diagnoses that include thoracic vertebra fracture T11- T12, paraplegia and urinary tract infection was admitted to the home care agency on 08/04/2021. Review of the RN Visit Note dated 08/09/2021 revealed the RN documented “bilateral lower extremity edema, compression stockings on.” Review of the clinical record from 08/04/2021 to 08/17/2021, when the patient transferred to an in-patient facility, lacks documented evidence of an order for compression stockings. The RN failed to obtain an order for compression stockings. During interview on 10/18/2021 at 11:30 AM, the RN stated she did not think an order for compression stockings was needed because the agency staff were not applying or removing the stockings. Patient #4 – This 91-year-old patient with diagnoses that include hypertensive heart disease with heart failure, acute on chronic diastolic (congestive) heart failure, and sick sinus syndrome was admitted to the home care agency on 09/10/2021. Review of the RN Visit Note dated 09/18/2021 revealed the RN documented “reviewed need to wear compression stockings to help manage the swelling in the lower extremities. Patient verbalized understanding and showed RN a pair of compression stockings that he has.” Review of the clinical record from 09/18/2021 to 09/21/2021 (discharge) lacks documented evidence of an order for compression stockings. During interview on 10/15/2021 at 01:28 PM, the RN stated she called the doctor and left a voicemail, but the documentation did not specify she discussed the compression stockings. Additionally, no order was obtained. Patient #10 – This 94-year-old patient with diagnoses that include acute embolism and thrombosis deep veins of left lower extremity, pressure-induced deep tissue damage of right heel, and urinary tract infection was admitted to the home care agency on 09/28/2021. Review of the After Visit Summary dated 10/04/2021 revealed the patient had a foley catheter placed in an ambulatory care center on 10/04/2021. Review of the RN Visit Note dated 10/05/2021 revealed the RN documented the patient has an indwelling/suprapubic catheter in place. Review of the clinical record from 10/04/2021 to 10/12/2021 (date of survey) lacks an order for the foley catheter to include frequency of changes, size, and who is responsible. The RN failed to obtain an order for a foley catheter. During interview on 10/15/2021 at 11:44 AM, the RN stated she did not obtain an order for the new foley.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of clinical records and interviews with agency staff for five (5) of seventeen (17) patients (Patient #'s: 5, 10, 11, 13, and 16), the agency failed to provide services in accordance with physician orders and the Plan of Care (POC). The issues are: - The Skilled Nurse (SN) failed to provide wound care as ordered (Patient #10). - The Physical Therapist (PT) failed to obtain weights as ordered (Patient #5). - The agency failed to provide Home Health Aide (HHA) services as ordered (Patient #’s 11 and 16). - The SN failed to assess the blood glucose as ordered (Patient #13). - The SN failed to perform mediport care as ordered (Patient #13). Failure to ensure patient care is provided in accordance with physician orders and the POC has the potential for patients to receive poor care and for health care needs to go unmet. Findings are: Patient #13 – This 52-year-old patient with diagnoses that include pneumonitis, adjustment and management of vascular access device and atherosclerotic heart disease was admitted to the home care agency on 09/30/2021. A.) Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed the following orders for the implanted vascular access device/ mediport: SN to change needle, dressing, caps and intravenous tubing every 7 (seven) days using sterile technique. Review of the Coordination Note Report dated 09/30/2021 revealed the RN documented the patient reported last accessing the port and changing the huber needle and dressing on 09/29/2021. The RN documented offering to change the IV (intravenous) port dressing during the visit and the patient declined the dressing change. The patient agreed to demonstrate the dressing change for the SN when the next dressing change is due. Review of the RN Visit Note dated 10/06/2021 revealed the RN documented the right chest wall port site is clean, dry and intact. The patient is declining a port dressing change at today’s visit (seven days after the port was documented to have last been accessed and the dressing changed). The agency failed to provide services in accordance with physician orders and the POC. During interview on 10/15/2021 at 12:55 PM, the RN stated the patient refused to demonstrate the port care or allow the port care to be completed during the visit. The RN stated she did not document this and should have. B.) Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed the following orders: - SN for instruction/ reinforcement of diabetes management including: diabetic foot care and monitoring diabetic control. Patient/ Caregiver checks blood sugars independently QID (four times a day). - Notify physician of FBS (fasting blood sugar) less than 70 or greater than 300. Review of the RN Visit Note dated 10/06/2021 lacks documented evidence of a blood sugar reading being obtained or reported. Review of the SN Visit Note dated 10/08/2021 lacks documented evidence of a blood sugar reading being obtained or reported. The agency failed to provide services in accordance with physician orders and the POC. During interview on 10/15/2021 at 01:00 PM, the RN stated the patient reported she had not checked her blood sugar yet for the day but the RN did not document this. During interview on 10/15/2021 at 01:10 PM, the Licensed Practical Nurse (LPN) stated the patient refused to check the blood sugar during the visit but the LPN did not document the refusal. Patient #5 – This 76-year-old patient with diagnoses that include thoracic vertebra fracture T11- T12, paraplegia and urinary tract infection was admitted to the home care agency on 08/04/2021. Review of the Add ON Discipline for Physical Therapy (PT) dated 08/05/2021 revealed orders for PT to monitor the patient’s weight PRN (as needed) and notify physician for measures that fall outside of physician- ordered parameters at rest. PT to provide skilled teaching related to the signs and symptoms of heart failure exacerbation and associated self- monitoring techniques. Review of the PT (Physical Therapy) Add- On Evaluation Visit dated 08/05/2021 revealed the PT documented the patient has 1 plus right lower edema and 2-3 plus left lower edema. The visit lacks documented evidence of a weight being obtained or recorded. Review of the PT Visit Note dated 08/16/2021 revealed the PT documented the patient has 2 to 3 plus pitting edema to the right lower extremity and 2 plus pitting edema to the left lower extremity. The visit lacks documented evidence of a weight being obtained or recorded. The agency failed to provide services in accordance with physician orders and the POC. During interview on 10/15/2021 at 03:45 PM, the PT stated he did not obtain and document the patient’s weight on the identified visits and should have. Patient #11 – This 60-year-old patient with diagnoses that include osteoarthritis, right shoulder complete rotator cuff tear and type II diabetes mellitus was admitted to the home care agency on 10/01/2021. Review of the Home Health Certification and Plan of Care for the certification period from 10/01/2021 to 11/29/2021 revealed orders for HHA (Home Health Aide) effective 10/03/2021 2wk4 (two times per week for four weeks). Review of the clinical record from lacks documented evidence the patient is receiving HHA services. The agency failed to provide services in accordance with physician orders and the POC. During interview on 10/15/2021 at 01:50 PM, the RN stated the patient has not received HHA services yet but the date on the POC reflects the date the aide POC is developed and the process started in setting up HHA services. Patient #16 – This 61-year-old patient with diagnoses that include idiopathic normal pressure hydrocephalus, unspecified lumbar vertebra fracture and unspecified thoracic vertebra fracture was admitted to the home care agency on 09/27/2021. Review of the Home Health Certification and Plan of Care for the certification period from 09/27/2021 to 11/25/2021 revealed orders for HHA 3wk3 (three times per week for three weeks. Review of the Coordination Note dated 09/30/2021 revealed the RN completed an aide service request on 09/30/2021 and requested service start 10/04/2021. Review of the clinical record lacks documented evidence the patient is receiving HHA services. The agency failed to provide services in accordance with physician orders and the POC. During interview on 10/15/2021 at 09:30 AM, the RN stated the aide POC was developed on 09/30/2021 but the patient has not received any aide services yet. Patient #10 – This 94-year-old patient with diagnoses that include acute embolism and thrombosis deep veins of left lower extremity, pressure-induced deep tissue damage of right heel, and urinary tract infection was admitted to the home care agency on 09/28/2021. Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 revealed the following orders: - SN to perform wound care to stage II pressure injury to sacral until healed: cleanse wound with soap and water or normal saline, apply skin prep around periwound then xeroform to wound bed as the primary dressing. Cover with foam/dry dressing as the secondary dressing. Change 2 (two) times weekly and PRN (as needed) for strikethrough drainage or dressing dislodgement using clean technique. - SN to perform wound care to unstageable pressure injury to heel. Cleanse with soap and water or normal saline. Apply xeroform to wound bed then foam dressing 2 (two) times a week and PRN (as needed) for strikethrough drainage and dislodgement. - No caregiver in the home. Patient niece able to do wound care only in emergency. She doesn’t live with patient and can’t be reliable for wound care routinely. She demonstrates independence. Review of the clinical record revealed from 09/28/2021 to 10/02/2021 revealed the patient received SN skilled nursing on 09/28/2021 and 09/30/2021. Review of the RN (Registered Nurse) Visit Note dated 09/30/2021 revealed the RN documented the following wound assessments for the stage II sacral wound and the unstageable ulcer on the right heel: “wound care not provided, not ordered this visit.” The agency failed to provide services in accordance with physician orders and the POC. During interview on 10/15/2021 at 08:41 AM, the RN stated that because of the way the visit was coded, she was unaware the patient was due for wound care. Additionally, she states the RN who did the start of care told her she would be out again that week to do the wound care, however she did not.

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on review of clinical records and interviews with agency staff for two (2) of seventeen (17) patients (Patient #’s 11 and 12), the agency failed to ensure the Plan of Care (POC) was reviewed and revised to reflect the patient's current status. Specifically, the POC was not updated regarding medication changes. Failure to ensure the POC is updated and revised to reflect patient needs, has the potential to result in negative patient outcomes. Findings are: Patient #11 – This 60-year-old patient with diagnoses that include osteoarthritis, right shoulder complete rotator cuff tear and type II diabetes mellitus was admitted to the home care agency on 10/01/2021. Review of the Home Health Certification and Plan of Care for the certification period from 10/01/2021 to 11/29/2021 revealed an order for Paroxetine 40 mg (milligrams) oral tablet daily. Review of the SN (Skilled Nurse) Visit Note dated 10/12/2021 revealed the following: patient medication was changed from Paroxetine 40 mg to Bupropion 150 mg effective 10/04/2021. The SN Visit Note lacks documented evidence of how the medication change was verified and that the care manager and physician were notified of the medication change. Review of the clinical record lacks documented evidence of an order reflecting the medication change. The agency failed to ensure the Plan of Care (POC) is reviewed and revised to reflect the patient's current status. During interview on 10/18/2021 at 09:55 AM, the SN stated she did not notify the physician and care manager of the medication changes or complete a supplemental order. HV Patient #12 – This 78-year-old patient with diagnoses that include paroxysmal atrial fibrillation, nonrheumatic aortic stenosis and end stage renal disease was admitted to the home care agency on 10/02/2021. Review of the Home Health Certification and Plan of Care for the certification period from 10/02/2021 to 11/30/2021 revealed an order for Nitroglycerin 0.4 mg (milligrams)/ hour transdermal patch, 1 (one) patch onto the skin daily. During observational home visit on 10/13/2021 at 11:10 AM, this Surveyor observed the Registered Nurse (RN) complete medication reconciliation with the patient’s son. The son verbalized the patient receives the Nitroglycerin patch every other day. Review of the RN Visit Note dated 10/13/2021 revealed the RN documented the patient is using the Nitroglycerin Patch every other day. The Visit Note lacks documented evidence the physician was notified of the patient using the Nitroglycerin Patch every other day. The agency failed to ensure the Plan of Care (POC) is reviewed and revised to reflect the patient's current status. During interview on 10/15/2021 at 10:05 AM, the RN stated the physician was notified of the discrepancy with the Nitroglycerin Patch order but she did not document this.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on a review of clinical records and interview with agency staff, for two (2) of seventeen (17) patients (Patient #’s 9 and 16), the agency failed to effectively coordinate services to support the objectives of the plan of care. Failure to ensure that adequate coordination occurs has the potential to result in poor quality of care. Findings are: Patient #9 – This 60-year-old patient with diagnoses that include type II diabetes mellitus, essential hypertension and chronic obstructive pulmonary disease was admitted to the home care agency on 09/30/2021. Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed the following orders: - SN (Skilled Nursing): 1wk1 (one time per week for one week), 1every2wk8, (one visit every two weeks for eight weeks). - SN may fill medi-planner per current medication orders/ profile biweekly. Review of the Client Coordination Note Report dated 09/30/2021 revealed the RN documented the patient’s mediset was filled for two weeks, but, medications Melatonin and Trazodone are missing for all weeks and the RN requested refills from the patient’s pharmacy. Review of the RN (Registered Nurse) OASIS (Outcome and Assessment Information Set) Admission Visit Note dated 09/30/2021 revealed the RN documented she did not communicate with other disciplines or Home Health Agency Staff involved in this case. Review of the RN Visit Note dated 10/13/2021 revealed the RN documented prefilling the mediset for two weeks and it was 100 percent completed. Review of the clinical record from 09/30/2021 to 10/13/2021 lacks documented evidence of follow-up regarding the incomplete mediset fill on 09/30/2021 and the need for follow-up to complete the mediset fill. The RN failed to ensure effective coordination with the case manager regarding the incomplete mediset prefill. During interview on 10/15/2021 at 12:15 PM, the RN stated she did not notify the case manager of the missing medications and incomplete mediset fill and should have done so. Patient #16 – This 61-year-old patient with diagnoses that include idiopathic normal pressure hydrocephalus, unspecified lumbar vertebra fracture and unspecified thoracic vertebra fracture was admitted to the home care agency on 09/27/2021. Review of the Home Health Certification and Plan of Care for the certification period from 09/27/2021 to 11/25/2021 revealed an order for Ondansetron 4 mg (milligrams) oral tablet, one tablet every 6 (six) hours as needed/PRN. Review of the Coordination Notes Report dated 09/27/2021 revealed the RN completed a one visit only (OVO) on 09/27/2021, documented the patient was prescribed Ondansetron for nausea and had not picked the medication up from the pharmacy at the time of the RN visit. Review of the RN OASIS Admission Visit Note dated 09/27/2021 lacks documented evidence the RN communicated with the agency staff that the patient did not have Ondansetron in the home. Review of the PT (Physical Therapy) Add- On Evaluation Visit Note dated 09/28/2021 lacks documented evidence that the PT confirmed if the Ondansetron was in the patient’s home. The RN failed to ensure effective coordination with the agency staff regarding the patient not having Ondansetron in the home. During interview on 10/13/2021 at 09:40 AM, the RN stated she followed up with the patient later that day and confirmed the Ondansetron was in the patient’s home but she did not document this.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interview for five (5) of seventeen (17) patients (Patient #'s: 3, 8, 9, 12, and 13), the agency failed to ensure the patient/caregiver receives appropriate education regarding the care and services identified in the plan of care (POC). Failure to provide appropriate education has the potential to result in the patient receiving inadequate care and could result in patient harm. Patient #3 – This 88-year-old patient with diagnoses that include fracture shaft of right fibula, type II diabetes mellitus without complications, and hypertension was admitted to the home care agency on 07/07/2021. Review of the Home Health Certification and Plan of Care for certification period 07/07/2021 to 09/04/2021 revealed “the patient/caregiver ensures diabetic management via A1C testing” and the following orders for diabetic injectable medications: - Tresiba U-100 insulin 100 unit/ml (milliliters) 50 units subcutaneous solution twice a day - Trulicity 3 mg/0.5 ml 0.5 ml subcutaneous pen injector weekly Review of the RN (Registered Nurse) OASIS (Outcomes and Assessment Information Set) dated 07/07/2021 lacks documented evidence the RN observed a demonstration of the patient/caregiver administrating insulin. Review of the clinical record lacks documented evidence the patient received appropriate education regarding the administration of insulin. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently administer a subcutaneous diabetic medication. During interview on 10/15/2021 at 10:00 AM, the RN stated the patient’s wife is responsible, and she did not observe her doing it because it was not due. Patient #8 – This therapy-only 81-year-old patient with diagnoses that include diffuse large B-cell lymphoma, hypothyroidism, and type II diabetes mellitus with diabetic neuropathy was admitted to the home care agency on 09/20/2021. Review of the Home Health Certification and Plan of Care for certification period 09/20/2021 to 11/18/2021 revealed “the patient/caregiver ensures diabetic management via BG (blood glucose) checks.” Review of the PT (Physical Therapy) OASIS dated 09/20/2021 lacks documented evidence the PT observed a demonstration of the patient/caregiver obtaining a blood glucose. Review of the clinical record lacks documented evidence the patient received appropriate education regarding obtaining a blood glucose. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently obtain a blood glucose. During interview on 10/15/2021 at 10:00 AM, the PT stated she did observe the patient demonstrating obtaining a blood glucose but did not document it. Findings are: Patient #9 – This 60-year-old patient with diagnoses that include type II diabetes mellitus, essential hypertension and chronic obstructive pulmonary disease was admitted to the home care agency on 09/30/2021. Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed orders for instruction/reinforcement of diabetes management including: diet, skin care, foot care, diabetic medications and patient/caregiver blood glucose testing before each meal. Review of the RN OASIS (Outcome and Assessment Information Set) Admission Visit Note Report dated 09/30/2021 revealed the RN documented the following: - The patient lives alone and has no assistance available at the home; - The patient is diabetic and is unable to complete blood glucose testing due to physical/cognitive limitations; - The physician is aware of the patient’s limitations regarding blood glucose testing; - Interventions provided: “observed patient with demonstration of blood sugar testing. Patient is independent/needs more education.” The 09/30/2021 RN assessment is unclear if the patient was assessed and if able to independently perform blood glucose testing. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently obtain a blood glucose. During interview on 10/15/2021 at 12:10 PM, the RN stated when the patient had an intermittent “schizophrenic” attack he was unable to test his blood glucoses independently, but was observed, when feeling better, and was independent with testing. The RN stated she should have included this in her assessment. Patient #12 – This 78-year-old patient with diagnoses that include paroxysmal atrial fibrillation, nonrheumatic aortic stenosis and end stage renal disease was admitted to the home care agency on 10/02/2021. Review of the Home Health Certification and Plan of Care for the certification period from 10/02/2021 to 11/30/2021 revealed orders for Skilled Nurse for instruction/reinforcement of diabetes management including diabetic foot care and monitoring diabetic control. Skilled Nurse will assess skin integrity as needed. “Patient independent with checks. Blood Sugar checks at random.” Review of the RN OASIS Admission Visit Note Report date 10/02/2021 lacked documented evidence of an assessment of the patient/caregiver’s ability to test blood glucoses. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently obtain a blood glucose. During interview on 10/15/2021 at 02:13 PM, the RN stated the patient’s caregiver reported he could test the blood glucose independently but he did not observe this. Patient #13 – This 52-year-old patient with diagnoses that include pneumonitis, adjustment and management of vascular access device and atherosclerotic heart disease was admitted to the home care agency on 09/30/2021. A.) Review of the Home Health Certification and Plan of Care for the certification period from 09/30/2021 to 11/28/2021 revealed orders for Skilled Nurse for instruction/reinforcement of diabetes management including diabetic foot care and monitoring diabetic control. Patient/caregiver checks blood sugars independently QID (four times daily). Review of the RN OASIS Admission Visit Note Report dated 09/30/2021 lacks documented evidence the RN observed a demonstration of the patient/caregiver performing a blood glucose test. Review of the clinical record lacks documented evidence the patient received appropriate education regarding obtaining a blood glucose. The agency failed to ensure the patient/caregiver was able to successfully re-demonstrate the ability to independently obtain a blood glucose. During interview on 10/15/2021 at 09:45 AM, the RN stated the patient verbalized independence with checking her blood glucose but she did not observe this.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on review of clinical records and interviews with staff, for one (1) of seventeen (17) patients (Patient #11), the agency failed to prepare and document complete clinical progress notes. Failure to prepare or document complete and accurate clinical and progress notes has the potential for unmet patient needs. Patient #11 – This 60-year-old patient with diagnoses that include osteoarthritis, right shoulder complete rotator cuff tear and type II diabetes mellitus was admitted to the home care agency on 10/01/2021. Findings are: A.) Review of the SN (Skilled Nursing) Visit Note dated 10/05/2021 revealed the SN documented that the patient’s blood glucose levels are maintained with prescribed antidiabetic agent (s). Review of the SN Visit Note dated 10/12/2021 revealed the SN documented that the patient’s blood glucose levels are maintained with prescribed antidiabetic agent (s). Review of the Home Health Certification and Plan of Care for the certification period from 10/01/2021 to 11/29/2021 revealed the patient was not ordered to take antidiabetic medications. The documentation is inconsistent. It is unclear if the patient is taking antidiabetic medications to control blood glucose levels. During interview on 10/15/2021 at 3:08 PM, the Licensed Practical Nurse (LPN) stated she made an error in her documentation and the patient was not taking any antidiabetic medications. During interview on 10/18/2021 at 09:55 AM, the LPN stated the patient told her she is prescribed medication to control diabetes but she does not take it. Additionally, the LPN stated she did not follow up regarding this and should have. B.) Review of the SN Visit Note dated 10/05/2021 revealed the SN documented the following: - Under the vital signs section, the patient’s pain was rated a 5 on a 0 to10 scale, with 10 being the worst pain imaginable, site not specified. - Under the pain assessment, the pain scale rating was 4 on a 0 to 10 scale to the right shoulder. - Under the narrative section, the SN documents the patient complains of pain 3 out of 10 to the right shoulder. The documentation is inconsistent. It is unclear what the actual numeric pain rating is during the 10/05/2021 SN Visit. During interview on 10/15/2021 at 03:10 PM, the LPN stated the pain ratings varied due to the patient being assessed at different times during visit but she did not specify this and should have. C.) Review of the SN Visit Note dated 10/05/2021 revealed the SN documented the following: - Has the patient recently utilized any pain control methods? No; - Indicate what interventions were provided as part of this comprehensive pain assessment: Other - Indicate what other pain intervention was provided: Both. The documentation is inconsistent. It is unclear what pain intervention was provided. During interview on 10/15/2021 at 03:13 PM, the LPN stated she made an error when she documented “both” and meant to document “rest” as the pain intervention provided.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on review of clinical records, agency policies and procedures, and staff interview, for three (3) of seventeen (17) patients (Patient #’s: 1, 7 and 10), the agency failed to follow agency policies and procedures, current clinical practice guidelines and accepted professional standards when providing services. The issues are: - The Registered Nurse (RN) failed to follow agency policy and procedure for wound assessments (Patient #’s 1, 7, and 10). - The RN failed to follow agency policy and procedure for Case Management Scheduling (Patient #1). Failure to follow agency policies and procedures and ensure compliance with accepted professional standards has the potential to result in unmet patient needs and inadequate care. Review of the agency’s policy entitled “Wound Care Standards of Practice” effective 06/2015 revealed “Wounds should be measured a minimum of once per week or if there is a significant change in wound status.” Patient #10 – This 94-year-old patient with diagnoses that include acute embolism and thrombosis deep veins of left lower extremity, pressure-induced deep tissue damage of right heel, and urinary tract infection was admitted to the home care agency on 09/28/2021. Review of the Home Health Certification and Plan of Care for certification period 09/28/2021 to 11/26/2021 revealed the orders: - SN to perform wound care to stage II pressure injury to sacral until healed: cleanse wound with soap and water or normal saline, apply skin prep around periwound then xeroform to wound bed as the primary dressing. Cover with foam/dry dressing as the secondary dressing. Change 2 (two) times weekly and PRN (as needed) for strikethrough drainage or dressing dislodgement using clean technique. - SN to perform wound care to unstageable pressure injury to heel. Cleanse with soap and water or normal saline. Apply xeroform to wound bed then foam dressing 2 (two) times a week and PRN (as needed) for strikethrough drainage and dislodgement. - No caregiver in the home. Patient niece able to do wound care only in emergency. She doesn’t live with patient and can’t be reliable for wound care routinely. She demonstrates independence. Review of the clinical record from 10/03/2021 to 10/09/2021 revealed the patient received nursing services on 10/05/2021 and 10/07/2021. A.) Review of the RN Visit Note dated 10/05/2021 revealed the RN documented the following wound assessments for the sacrum and the right heel: - Measurements taken: no - Reason measurements not taken: not due The RN failed to follow agency policy and procedure for wound assessments. During interview on 10/15/2021 at 11:46 AM, the RN stated the visits are usually coded to prompt her when to obtain measurements, but this one was incorrectly coded, and she forgot. B.) Review of the RN Visit Note dated 10/07/2021 revealed the RN documented the following wound assessments for the stage II sacral ulcer and the unstageable ulcer on the right heel: - Measurements taken: no - Reason measurements not taken: not due The RN failed to follow agency policy and procedure for wound assessments. During interview on 10/15/2021 at 08:42 AM, the RN stated she forgot to obtain wound measurements. Patient #7 – This 78-year-old patient with diagnoses that include pressure ulcer of the sacral region, stage 3, pressure ulcer of right heel, unstageable, and dementia with lewy bodies was admitted to the home care agency on 10/01/2019. Review of the Home Health Certification and Plan of Care for certification period 09/20/2021 to 11/18/2021 revealed the following wound care order: “SN to perform wound care to sacral area until healed. Cleanse wound with vashe, apply endoform and hydrofera blue as the primary dressing. Apply foam as the secondary dressing. Change 3 (three) times weekly and PRN (as needed) for strikethrough drainage or dressing dislodgement.” Review of the clinical record from 09/19/2021 to 09/25/2021 revealed the patient received nursing services on 09/22/2021. Review of the RN Visit Note dated 09/22/2021 revealed the RN documented “wound on heal almost complete healed.” Review of the RN Visit Note dated 09/22/2021 revealed the RN documented the following wound assessments for the stage III sacral ulcer: - Measurements taken: no - Reason measurements not taken: wound care completed The RN failed to follow agency policy and procedure for wound assessments. During interview on 10/15/2021 at 12:46 PM, the RN stated she forgot to document wounds measurements. Findings are: Patient #1 – This 37-year-old patient with diagnoses that include aftercare following surgery to skin, stage II pressure ulcer to sacrum and sepsis was admitted to the home care agency on 03/31/2021. Review of the Home Health Certification and Plan of Care from 03/31/2021 to 05/29/2021 revealed wound care orders to a pubic incision and stage 2 pressure ulcer on buttock until healed. SN to cleanse wound with soap and water, apply triad cream to buttock, Saline dampened gauze pack to surgical wound as the primary dressing. Apply dry dressing over surgical wound as the secondary dressing. Dressing to buttock apply twice a day, change dressing to pubic incision every other day and as needed for strikethrough drainage or dressing dislodgement using clean technique. Patient/ Caregiver may be taught to perform wound care. Review of the Client Coordination Note dated 04/14/2021 revealed the patient’s coccyx (stage 2 pressure ulcer) healed and wound care was to continue to pubic incision. Review of the Physician Order dated 05/09/2021 revealed new wound care orders to the superior pubic region surgical incision to include cleansing with normal saline, patting dry, packing with hydrofiber (absorbent material) rope dressing and covering with dry dressing. SN to change dressing every other day and as needed for soiling or dislodgement until healed. Review of the clinical record for the week of 05/09/2021 through 05/15/2021 revealed the patient received SN visits on the following dates: 05/09/2021, 05/11/2021. 05/13/2021 and 05/15/2021. Review of the SN Visit Notes for the week of 05/09/2021 through 05/15/2021 lacks documented evidence of a wound assessment being performed to include obtaining wound measurements. Review of the clinical record for the week of 05/16/2021 through 05/22/2021 revealed the patient received SN visits on 05/17/2021, 05/19/2021 and 05/22/2021. Review of the SN Visit Notes for the week of 05/16/2021 through 05/22/2021 lacks documented evidence of a wound assessment being performed to include obtaining wound measurements. The RN failed to follow agency policy and procedure for performing wound assessments. During interview on 10/15/2021 at 11:00 AM, the Clinical Nurse Manager stated the patient’s Care Management Nurse no longer works for the agency. The Clinical Nurse Manager stated it was the agency expectation that wounds get measured weekly and she acknowledged the wound was not measured on any of the identified visits. B.) Review of the agency policy entitled “Scheduling Protocol, Case Manager’s” dated 02/28/2012 revealed “Case Manager (CM) Responsibilities…Expectation: CM will see their patients a minimum of weekly, but as often as possible.” Review of the SN Visit Notes for the week of 04/25/2021 through 04/29/2021 revealed the Case Manager performed a SN Visit on 04/29/2021. Review of the SN Visit Notes for the week of 05/02/2021 through 05/08/2021 lacks documented evidence the Case Manager performed a visit. Review of the SN Visit Notes for the week of 05/09/2021 through 05/15/2021 lacks documented evidence the Case Manager performed a visit. Review of the SN Visit Notes for the week of 05/16/2021 through 05/22/2021 lacks documented evidence the Case Manager performed a visit. The Case Manager RN failed to follow agency policy and procedure for assessing the patient weekly. During interview on 10/15/2021 at 11:05 AM, the Clinical Nurse Manager stated the patient’s Case Manager no longer works for the agency. The Clinical Nurse Manager acknowledged the patient’s Case Manager did not make a home visit during the identified weeks and stated it was expectation that Case Managers see their patients weekly, at minimum.