Every finding on record at Comfort Care Medicare Inc

The Department of Inspections, Appeals and Licensing conducted a complaint survey for complaint # 2727726-C from 2/2/26 to 2/4/26. The complaint survey identified the following: Condition of Participation 42 CFR 484.50 Patient Rights, was investigated and one condition level deficiency was identified and one standard level deficiency; and Condition of Participation 42 CFR 484.60 Care Planning, Coordination of Services and Quality of Care, was investigated and no condition level deficiency was identified and three standard level deficiencies were identified. The agency reported a census of 216 patients at the time of the survey including 52 patients in the parent office in Cedar Rapids, 42 patients in the Cedar Falls branch, 64 patients in the Davenport branch, 17 patients in the Dubuque branch and 41 patients in the Irving Point branch. As a result of the agency's noncompliance with the Medicare Conditions of Participation for home health agencies, the home health agency and its registered nurses are prohibited from providing basic skills competency training, and prohibited from providing evaluation of home health aide written basic skills testing and evaluation of demonstrated competency of the hands on basic skills for the agency's home health aides for 2 years, beginning on 2/4/26 and ending on 2/4/28.

Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on clinical record review, home visit observation, agency policy review and agency staff interview, the agency failed to ensure the patient had the right to participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to completion of all assessments, care to be furnished, establishing and revising the plan of care, disciplines that will furnish the care, frequency of visits, expected outcomes of care, factors that could impact treatment effectiveness, and any changes in the care to be furnished. (G434) The cumulative and egregious effects of these systemic practices resulted in the failure to ensure the organizational framework of the agency promoted and supported the coordination of safe and effective delivery of care to the agency’s 216 patients.

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 staff interview, agency policy review, and clinic record review, the agency failed to ensure the patient participated in, was informed about, and gave consent or refused care in advance of and during treatment for 6 of 6 sampled patients (Patients #1, #2, #3, #4, #5, and #6). Failure to ensure agency staff ensured the patient participated in, was informed about, and gave consent or refused care in advance of and during treatment before the agency initiated care or during care placed agency patient at risk for the patient's rights being violated and services provided without consent. Findings include: 5. Patient #1 had a start of care date of 1/5/26. Clinical record review revealed: a. Plan of Care, dated 1/5/26 to 3/5/26, included primary diagnosis of cardiomyopathy and physician orders for skilled nursing, home health aide, physical therapy and occupational therapy services. During an interview on 2/3/26 at 2:52 PM, Staff F, Office Manager, surveyor requested to review copies of admission consents, Staff F reported the consents should have been scanned into the electronic medical record by now, she would look for them and provide to surveyor. During an interview on 2/4/26 at 8:35 AM, Staff F, reported agency was unable to locate the admission consents. 6. Patient #3 had a start of care date of 3/23/22. Clinical record review revealed: a. Plan of Care, dated 1/1/26 to 3/1/26, included primary diagnosis of COPD and physician orders for skilled nursing and home health aide services. b. Admission consents, signed by patient and dated 3/23/22. Clinical record lacked documentation of annual consent forms completed for years 2023, 2024 or 2025. Findings were reviewed with Staff B, Director of Human Resources and Staff F, Office Manager. According to the agency policy titled Admission Documents, updated August 2024, annual admission consents and releases of information will be reviewed and signed by the patient and clinician. According to the agency policy titled Admission Criteria and Process, updated August 2024, the patient or his/her representative will sign the required forms indicating acceptance of services and receipt of patient rights and privacy information. 1.Patient #2 had a start of care date of 5/22/24. Clinical record review revealed: The Plan of Care (POC) dated 1/12/26 to 3/12/26 included orders for skilled nursing and home health aide services. The patient had a diagnosis of chronic obstructive pulmonary disease (COPD). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 2.Patient #4 had a start of care date of 3/6/24. Clinical record review revealed: The Plan of Care (POC) dated 12/26/25 to 2/23/26 included orders for skilled nursing, home health aide, and physical therapy. The patient had a diagnosis of encephalopathy (disease of the brain that alters brain function or structure). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. In an interview on 2/3/26 at 9:43 AM, Staff F, Office Manager, reported that she and Staff B, Director of Human Resources, were not able to locate Patient #4's annual consents. Staff F reported that the patient should have annual paperwork in the chart. 3. Patient #6 had a start of care date of 8/15/24. Clinical record review revealed: The Plan of Care (POC) dated 12/8/25 to 2/5/26 included orders for skilled nursing and home health aide. The patient had a diagnosis of chronic obstructive pulmonary disease (COPD). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 4.Patient #5 had a start of care date of 8/17/23. Clinical record review revealed: a.The Plan of Care (POC), dated 12/4/25 to 2/1/26, included orders for skilled nursing. The Plan of Care (POC) did not include a diagnosis. b.Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 1. Patient #1 had a start of care date of 1/5/26. Clinical record review revealed: a. Plan of Care, dated 1/5/26 to 3/5/26, included primary diagnosis of cardiomyopathy and physician orders for skilled nursing, home health aide, physical therapy and occupational therapy services. During an interview on 2/3/26 at 2:52 PM, Staff F, Office Manager, surveyor requested to review copies of admission consents, Staff F reported the consents should have been scanned into the electronic medical record by now, she would look for them and provide to surveyor. During an interview on 2/4/26 at 8:35 AM, Staff F, confirmed the agency was unable to locate Patient #1's admission consents. Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. According to the agency policy titled Admission Documents, updated August 2024, annual admission consents and releases of information will be reviewed and signed by the patient and clinician. 2.Patient #2 had a start of care date of 5/22/24. Clinical record review revealed: The Plan of Care (POC) dated 1/12/26 to 3/12/26 included orders for skilled nursing and home health aide services. The patient had a diagnosis of chronic obstructive pulmonary disease (COPD). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 2.Patient #4 had a start of care date of 3/6/24. Clinical record review revealed: The Plan of Care (POC) dated 12/26/25 to 2/23/26 included orders for skilled nursing, home health aide, and physical therapy. The patient had a diagnosis of encephalopathy (disease of the brain that alters brain function or structure). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. In an interview on 2/3/26 at 9:43 AM, Staff F, Office Manager, reported that she and Staff B, Director of Human Resources, were not able to locate Patient #4's annual consents. Staff F reported that the patient should have annual paperwork in the chart. 3. Patient #6 had a start of care date of 8/15/24. Clinical record review revealed: The Plan of Care (POC) dated 12/8/25 to 2/5/26 included orders for skilled nursing and home health aide. The patient had a diagnosis of chronic obstructive pulmonary disease (COPD). Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 4.Patient #5 had a start of care date of 8/17/23. Clinical record review revealed: a.The Plan of Care (POC), dated 12/4/25 to 2/1/26, included orders for skilled nursing. The Plan of Care (POC) did not include a diagnosis. b.Review of the clinical record failed to include an annual admission consent signed by the patient and clinician. 5. Patient #1 had a start of care date of 1/5/26. Clinical record review revealed: a. Plan of Care, dated 1/5/26 to 3/5/26, included primary diagnosis of cardiomyopathy and physician orders for skilled nursing, home health aide, physical therapy and occupational therapy services. During an interview on 2/3/26 at 2:52 PM, Staff F, Office Manager, surveyor requested to review copies of admission consents, Staff F reported the consents should have been scanned into the electronic medical record by now, she would look for them and provide to surveyor. During an interview on 2/4/26 at 8:35 AM, Staff F, reported agency was unable to locate the admission consents. 6. Patient #3 had a start of care date of 3/23/22. Clinical record review revealed: a. Plan of Care, dated 1/1/26 to 3/1/26, included primary diagnosis of COPD and physician orders for skilled nursing and home health aide services. b. Admission consents, signed by patient and dated 3/23/22. Clinical record lacked documentation of annual consent forms completed for years 2023, 2024 or 2025. Findings were reviewed with Staff B, Director of Human Resources and Staff F, Office Manager.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on staff interviews, agency policy, and clinical record review and the agency failed to follow a Plan of Care (POC) established and periodically reviewed by a physician or notify the physician of the need to vary frequency of visits or inability to perform treatments/services as originally ordered on the Plan of Care (POC) for 3 of 6 sampled patients (Patients #2, #3, and #5). Failure to follow a Plan of Care (POC) established by home health clinical associates in collaboration with the patient's physician, placed patients at risk of not receiving safe, individualized and consistent care designed to meet each patient's health care needs. Findings include: 3. Patient #3 had a start of care date of 3/23/22. Clinical record review revealed: a. Plans of Care, dated 11/2/25 to 12/31/25 and 1/1/26 to 3/1/26, included primary diagnosis of chronic obstructive pulmonary disease and physician orders for skilled nursing services once a week and home health aide services twice a week. b. Unsigned Occupational Therapy (OT) orders, dated 12/4/25, signed by Staff I, OT included services to be provided twice a week. c. Occupational therapy visit notes, dated 12/10/25 and 12/15/25, signed by Staff K, COTA (certified occupational therapy assistant) identified visits were completed. The clinical record failed to identify a second occupational therapy visit for the weeks of 12/7/25 and 12/14/25, a reason why the visits were not made or documentation the physician was notified. d. Home health aide visit note, dated 12/22/25, signed by Staff J, Home Health Aide, identified visit was completed. The clinical record failed to identify a second home health aide visit for the week of 12/21/25, a reason why the visit was not made or documentation the physician was notified. The agency failed to provide occupational therapy and home health aide services as ordered or notify the physician of the missed visits. Findings were reviewed with Staff B, Director of Human Resources and Staff F, Office Manager. According to agency policy titled Care Planning Process, updated August 2025, on the occasion of a missed visit for all disciplines, due to a change in frequency, a missed visit report is filled and faxed to the doctor. In an interview on 2/4/26 at 9:12 AM, Staff, Office Manager, reported that she was not able to find missed visit notification to the doctor for missed visits from Patients #2 and Patient #5. Staff F reported that home health aides inform her when they miss a visit and then Staff F sends missed visit notification to the doctor. Staff F reported nurses send missed visit notification to the doctor when they miss a nursing visit. 1.Patient #2 had a start of care date of 5/22/24. Clinical record review revealed: a.The Plan of Care (POC) dated 11/13/25 to 1/11/26 included orders for 1 skilled nursing visit per week and 2 home health aide visits per week. The patient had a diagnosis of chronic obstructive pulmonary disease (COPD). b. The clinical record lacked documentation of skilled nurse services for the week of 1/4/26, and lacked physician notification of the missed visit. c. The Clinical record lacked documentation of a second home health aide visit the week of 12/28/25 and lacked physician notification of the missed visit. The agency failed to provide skilled nursing services or home health aide services as ordered or notify the physician of the missed visits. 2.Patient #5 had a start of care date of 8/17/23. Clinical record review revealed: a.The Plan of Care (POC) dated 12/4/25 to 2/1/26 included orders for 1 skilled nursing visit per week. The Plan of Care (POC) did not include the patient's diagnosis. b. The clinical record lacked documentation of skilled nurse services the week of 12/28/25 and the week of 1/25/26, and lacked physician notification of the missed visits. The agency failed to provide skilled nursing services as ordered or notify the physician of the missed visits.

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 staff interview, agency policy, and clinical record, the agency failed to include the patient's diagnosis on the Plan of care (POC) for 1 of 6 patient reviewed (Patient #5). Failure to maintain complete and accurate POCs with current orders placed patients at risk to not receive services, supplies, medications, and/or treatment according to assessed needs and physician orders. Findings include: According to the agency policy titled Care Planning Process, updated August 2025, the clinical POC includes pertinent primary and secondary diagnoses. Patient #5 had a start of care date of 8/17/23. Clinical record review revealed: The POC, dated 12/4/25 to 2/1/26 did not include the patient's diagnosis. The agency failed to include all required components of the POC, to include diagnosis. In an interview on 2/3/26 at 11:33 AM, Staff F, Office Manager, reviewed the patient's POC and confirmed that the diagnosis was not included. The above findings were reviewed with the Director of Human Resources and Office Manager.

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 agency policy review, clinical record review and agency staff interview, the agency failed to provide medications, treatments or services only as ordered by the physician for 3 of 4 sampled patients with therapy services (Patients #1, #2, and #3). Failure to ensure staff obtain physician orders for administration of medications, treatments or services provided by agency staff placed agency patients at risk for inconsistent care/treatment and possible harm. Findings include: 2. Patient #1 had a start of care date of 1/5/26. Clinical record review revealed: a. Plan of Care, dated 1/5/26 to 3/5/26, included primary diagnosis of cardiomyopathy and physician orders for physical therapy and occupational therapy services to evaluate and treat. b. Physical Therapy (PT) evaluation and plan of treatment, dated 1/9/26, signed by Staff L, PT, included orders for physical therapy one time a week for one week and then two times a week for 60 days. The document was unsigned by a physician. c. Physical Therapy visit notes, dated 1/14/26, 1/16/26, 1/19/26, 1/21/26, 1/26/26 and 1/30/26, signed by Staff M, PTA (physical therapy assistant) included documentation services were provided. d. Occupational Therapy evaluation and plan of treatment, dated 1/9/26, signed by Staff I, OT, included orders for occupational therapy one time a week for one week and then two times a week for 60 days. The document was unsigned by a physician. e. Occupational Therapy visit notes, dated 1/13/26, 1/16/26, 1/19/26, 1/23/26, 1/27/26 and 1/29/26, signed by Staff K, COTA (certified occupational therapy assistant), included documentation services were provided. During an interview on 2/3/26 at 4:00PM, Staff B, Director of Human Resources, reported therapy evaluations are not getting printed out and sent to the physician for signature. This was identified when printing documents for surveyor. All orders were printed out today and faxed to physician. The agency provided Physical Therapy and Occupational Therapy services without a physician order. 3. Patient #3 had a start of care date of 3/23/22. Clinical record review revealed: a. Plans of Care, dated 11/2/25 to 12/31/25, included primary diagnosis of chronic obstructive pulmonary disease and physician orders for occupational therapy services to evaluate and treat. b. Plans of Care, dated 1/1/26 to 3/1/26, included primary diagnosis of chronic obstructive pulmonary disease and physician orders for skilled nursing and home health aide services. c. Occupational Therapy reassessment notes, dated 12/4/25 and 1/2/26, signed by Staff I, OT, included orders for occupational therapy two times a week for up to 60 days. The documents were unsigned by a physician. d. Occupational Therapy visit notes, dated 12/10/25, 12/15/25, 12/23/25, 12/30/25, 1/6/26, 1/14/26 and 1/15/26, signed by Staff K, COTA, included documentation services were provided. e. Occupational Therapy visit notes, dated 12/24/25, 1/2/26 and 1/9/26, signed by Staff I, OT, included documentation services were provided. The agency provided Occupational Therapy services without a physician order. Findings were reviewed with Staff B, Director of Human Resources and Staff F, Office Manager. 1.Patient #2 had a start of care date of 5/22/4. Clinical record revealed: a.The Plan of Care (POC) dated 11/13/25 to 1/11/26 included a diagnosis of chronic obstructive pulmonary disease (COPD) and order for Occupational Therapy (OT) to evaluate and treat the patient. b.The OT evaluation, dated 11/13/25, signed by Staff I, Occupational Therapist (OT), included orders for OT services 1 visit for 1 week and then 2 visits per week for 60 days. The order was not signed by the physician. c.OT visit notes, dated 11/26/25 and 12/4/25, signed by Staff K, PTA (physical therapy assistant) included documentation services were provided. OT visit note, dated 12/11/25, signed by Staff N, OT, included documentation services were provided. The agency provided OT services to the patient without a physician's order.

A recertification survey was conducted by the Department of Inspections and Appeals and Licensing from 8/12/24 through 8/15/24. The recertification survey found the agency operating out of compliance with the following standard level regulatory requirements for Emergency Preparedness:

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on review of the agency's emergency preparedness plan, related policies and procedures and staff interview, the agency failed to ensure the emergency preparedness plan reviewed every 2 years. Failure to ensure the integrated health emergency preparedness plan reviewed every 2 years placed patients at risk for the agency failing to have resources and/or the means to provide services to agency patients during a time of disaster or emergency. Findings include: Review of the agency's emergency preparedness plan identified the plan last reviewed on 7/1/2021. The plan identified how the agencies involved in the plan would respond to various disasters and emergencies. During an interview on 8/14/24 at 8:55 AM Staff B, Human Resources Manager stated the agency did not have an updated emergency plan. The findings were reviewed with the Administrator, Human Resource Manager, Corporate Liaison, Staff C, Nursing Supervisor and Staff D, Nursing Supervisor.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on review of agency's emergency preparedness plan/policies, review of the agency's admission packet, clinical record review, home visit observation and agency staff interview, the home health agency failed to complete an individualized emergency plan developed as part of the comprehensive assessment, maintaining documentation of the plan in the patient's chart and in the patient's home setting, for 1 of 3 sampled patients with home visits (Patient #3). Failure to ensure the agency completed an individualized emergency plans developed as part of the comprehensive assessment and failure to ensure the patient has knowledge of the identified Plan placed patients at risk for staff being unaware and unprepared to respond in a timely and effective manner to potential health and safety hazards the patient may encounter. Findings include: According to the agency's policy titled Emergency Preparedness Plan, dated July 1, 2021, detailed written instructions will be given to patients and/or family members to ensure an appropriate and timely response in the event of an emergency event that may cause interruptions of services. Information provided may include: emergency contact telephone numbers, names of contact persons, local resources, evacuation routes, availability of local shelters and other community resources, methods to obtain needed medications, supplies, and equipment and necessity of having a plan for obtaining food/water, caring for pets and obtaining important documents. Patient #3 had a start of care date of 8/2/24. Clinical record review revealed the following: a. The Plan of Care (POC), dated 8/2/24 to 9/30/24, included the diagnosis of Type II diabetes mellitus with diabetic neuropathy. b. The POC, dated 8/2/24 to 9/30/24, identified an emergency preparedness assessment of Level 3. The assessment identified the plan was reviewed with the patient but lacked documentation the emergency plan was provided to the patient. c. During a home visit observation on 8/13/24 with Staff F, Physical Therapy Assistant (PTA), review of the agency's admission packet provided to the patient included a blank emergency care plan form but did not include an individualized emergency plan. The agency failed to provide the patient with a written completed individualized emergency plan. The findings were reviewed with the Administrator, Human Resource Manager, Corporate Liaison, Staff C, Nursing Supervisor and Staff D, Nursing Supervisor.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on agency staff interview, agency policy review and review of emergency preparedness testing documentation, the agency failed to ensure participation an emergency preparedness exercises annually. Failure to conduct or participate in emergency preparedness exercises placed patients at risk for not having trained and prepared staff to assist them in the event of an emergency. Findings include: According to the agency policy, titled Emergency Preparedness Policy and dated 7/1/21, the emergency preparedness testing requirement exercises will be conducted at least bi-annually and will focus on the organization's response to an emergency that is likely to affect continuation of care, treatment or services. Exercise scenarios will allow the organization to evaluate its handling of communication, resources and assets, staff and patients One drill will be agency wide and one will be a full-scale. Emergency preparedness training documentation included an emergency preparedness exercise, dated 9/15/23. The agency lacked any documentation of an additional training exercise in 2022. During an interview on 8/14/24 at 8:55 AM, Staff B, Human Resources Manager reported that the agency did not participate in an additional exercise in 2022. The findings were reviewed with the Administrator, Human Resource Manager, Corporate Liaison, Staff C, Nursing Supervisor and Staff D, Nursing Supervisor.

A Recertification Survey was conducted by the Department of Inspections, Appeals and Licensing from 8/12/24 through 8/15/24. The recertification survey found the agency operating out of compliance with the following standard level regulatory requirements: The agency identified a census of 217 current patients included 37 in the Cedar Rapids parent office, 58 in the Cedar Falls branch, 21 in the Coralville branch, 53 in the Davenport branch, 19 in the Dubuque branch and 29 in the Cedar Rapids branch.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on clinical record review, agency policy review, and agency staff interview, the agency failed to comprehensively provide wound assessments for 1 of 3 sampled patients with wounds (Patients #7) and failed to provide a comprehensive patient assessment with recertification assessments 1 of 2 patients with wounds (Patient #7). Failure to accurately and thoroughly complete wound assessments or provide a comprehensive assessment placed patients at an increased risk of unidentified condition changes. Findings include: Patient #7 had a Start of Care date of 8/30/23 and a Discharge date of 12/15/23. Clinical record review revealed the following: a. The Plans of Care, dated 8/30/23 to 10/28/24 and 10/29/24 to 12/27/2023, included orders for skilled nursing services weekly. b. Start of care comprehensive assessment, dated 8/30/23, included documentation the patient had a Stage 2 pressure ulcer but lacked wound location or measurements. c. Discharge comprehensive assessment, dated 12/15/23, included documentation the patient had Stage1 pressure ulcer, Stage 2 pressure ulcer and 1 deep tissue injury but lacked wound location or measurements. d. Skilled nursing visit note, dated 10/20/23, included documentation of left outer ankle wound and left lateral below knee high calf burn but lacked documentation of wound measurements. e. Skilled nursing visit note, dated 11/10/23, lacked documentation of wounds. f. Skilled nursing visit note, dated 11/17/23, included documentation of left outer ankle wound, right outer ankle wound and left lateral below knee high calf burn but lacked documentation of wound measurements. g. Skilled nursing visit note, dated 11/24/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. h. Wound Care Flow Sheet, dated 11/24/23, included documentation of left below knee high calf wound scab, 6 centimeters (cm) x 1.5 cm; right outer ankle wound 1.5 cm x 1.5 cm; left outer ankle wound 1 cm x 1 cm; right sole area 3 cm x 2 cm; multiple high hamstring low buttocks that lacked wound measurements and multiple coccyx bone area that lacked wound measurements. The wound measurements for right outer ankle, left outer ankle and right sole area wounds lacked wound depth. i. Skilled nursing visit note, dated 12/1/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. j. Wound Care Flow Sheet, dated 12/1/23, included documentation of left below knee high calf wound scab, 5 cm x 1.5 cm; right outer ankle wound 0.5 cm x 0.5 cm; left outer ankle wound 0.5 cm x 0.5 cm; right sole area 3 cm x 2 cm; multiple high hamstring low buttocks that lacked wound measurements and multiple coccyx bone area that lacked wound measurements. The wound measurements for right outer ankle, left outer ankle and right sole area wounds lacked wound depth. k. Skilled nursing visit note, dated 12/8/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. l. Wound Care Flow Sheet, dated 12/8/23, included documentation of left below knee high calf wound scab, 4 cm x 1 cm; right outer ankle wound healed; left outer ankle wound healed; right sole area blister 3 cm x 2 cm; multiple high hamstring low buttocks 1 cm x 1 cm and multiple coccyx bone left of 3.5 cm x 2.5 cm x 1.5 cm. The wound measurements for multiple high hamstring low buttocks lacked wound depth. The nurse failed to obtain complete wound measurements weekly per agency policy. The agency provided no additional information prior to the end of the survey. According to the agency policy titled Wound Care Standards, dated 1/2021, at a minimum all wounds must be assessed weekly by the Registered Nurse (RN) Case Manager or designated RN. This includes measurements of length, width, and depth (when applicable). During an interview on 8/12/24 at 3:30 PM, Staff C, RN supervisor stated staff document measurements weekly on the adobe fill and sign document. The document reviewed by the RN supervisor and uploaded everyday into the electronic medical record. According to the agency policy titled Wound Care Standards, dated 1/2021, at a minimum all wounds must be assessed weekly by the Registered Nurse (RN) Case Manager or designated RN. This includes measurements of length, width, and depth (when applicable). During an interview on 8/12/24 at 3:30 PM, Staff C, RN supervisor stated staff document wound measurements weekly on the adobe fill and sign document. The document is reviewed by the RN supervisor and uploaded everyday into the electronic medical record. 1. Patient #7 had a Start of Care date of 8/30/23 and a Discharge date of 12/15/23. Clinical record review revealed the following: a. The Plans of Care, dated 8/30/23 to 10/28/24 and 10/29/24 to 12/27/2023, included orders for skilled nursing services weekly. b. Start of care comprehensive assessment, dated 8/30/23, included documentation the patient had a Stage 2 pressure ulcer but lacked wound location or measurements. c. Discharge comprehensive assessment, dated 12/15/23, included documentation the patient had Stage1 pressure ulcer, Stage 2 pressure ulcer and 1 deep tissue injury but lacked wound location or measurements. d. Skilled nursing visit note, dated 10/20/23, included documentation of left outer ankle wound and left lateral below knee high calf burn but lacked documentation of wound measurements. e. Skilled nursing visit note, dated 11/10/23, lacked documentation of wounds. f. Skilled nursing visit note, dated 11/17/23, included documentation of left outer ankle wound, right outer ankle wound and left lateral below knee high calf burn but lacked documentation of wound measurements. g. Skilled nursing visit note, dated 11/24/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. h. Wound Care Flow Sheet, dated 11/24/23, included documentation of: left below knee high calf wound scab, 6 centimeters (cm) x 1.5 cm; 2. right outer ankle wound 1.5 cm x 1.5 cm; 3. left outer ankle wound 1 cm x 1 cm; right sole area 3 cm x 2 cm; 4. multiple high hamstring low buttocks that lacked wound measurements and 5. multiple coccyx bone area that lacked wound measurements. The wound measurements for right outer ankle, left outer ankle and right sole area wounds lacked wound depth. i. Skilled nursing visit note, dated 12/1/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. j. Wound Care Flow Sheet, dated 12/1/23, included documentation of left below knee high calf wound scab, 5 cm x 1.5 cm; right outer ankle wound 0.5 cm x 0.5 cm; left outer ankle wound 0.5 cm x 0.5 cm; right sole area 3 cm x 2 cm; multiple high hamstring low buttocks that lacked wound measurements and multiple coccyx bone area that lacked wound measurements. The wound measurements for right outer ankle, left outer ankle and right sole area wounds lacked wound depth. k. Skilled nursing visit note, dated 12/8/23, included documentation of multiple wounds but lacked documentation of wound location or measurements. l. Wound Care Flow Sheet, dated 12/8/23, included documentation of left below knee high calf wound scab, 4 cm x 1 cm; right outer ankle wound healed; left outer ankle wound healed; right sole area blister 3 cm x 2 cm; multiple high hamstring low buttocks 1 cm x 1 cm and multiple coccyx bone left of 3.5 cm x 2.5 cm x 1.5 cm. The wound measurements for multiple high hamstring low buttocks lacked wound depth. The nurse failed to obtain complete wound measurements weekly per agency policy. The agency provided no additional information prior to the end of the survey.

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 observations, agency staff interviews, record reviews, and policy review, the home health agency failed to ensure the drug regimen review identified at a minimum the effectiveness of drug therapy, drug side effects, actual or potential drug interactions, duplicate drug therapy, and/or patient compliance with medications for 7 of 8 sampled patients (Patients #1, #2, #3, #5, #6, #7 and #8). Failure to ensure medications reviewed at the time of each drug regimen review are current and accurate and failure to identify actual/ potential concerns increased the potential for unidentified medication interactions and side effect risks to the patient at the time of each comprehensive assessment. 6.Patient #1 had a start of care date of 2/23/21. Clinical record review revealed the following: a. Plans of Care, dated 4/8/24 to 6/6/24, 6/7/24 to 8/5/24 and 8/6/24 to 10/4/24, included medication orders for biofreeze gel and cool heat gel, pain medications. b. The Drug Regimen Review forms, dated 4/3/24, 6/3/24 and 8/5/24, identified no duplicate drug therapy. The drug regimen review failed to identify the duplicate pain medications. 7. Patient #7 had a start of care date of 8/30/23 and a discharge date of 12/15/23. Clinical record review revealed the following: a. The Plans of Care, dated 8/30/23 to 10/28/24 and 10/29/24 to 12/27/2023, included orders temazepam, zolpidem and trazodone (sleeping medications); escitalopram and mirtazapine (antidepressants); polyethylene glycol and fleet enema (bowel medications) and ben gay and lyrica (pain medications). b. The Drug Regimen Review forms, dated 8/30/23, 10/30/23 and 12/18/23, identified no duplicate drug therapy. The drug regimen review failed to identify the duplicate pain medications. The agency provided no additional information prior to the end of the survey. 4. Patient #5 had a start of care date of 7/10/24. Clinical record revealed the following: a. The POC, dated 7/10/24 to 9/7/24, included medication orders for Acetaminophen, Tylenol 8 hour and Hydrocodone (pain medications), Docusate sodium and Miralax (bowel medications), Calcium, Ferrous Sulfate, Vitamin B complex, Vitamin D and Vitamin D3 (supplements), Clopidogrel, Aspirin and Eliquis (coagulation agents) and Clonazepam, Quetiapine, Quviviq and Ropinirole (central nervous system agents). b. The Drug Regimen Review form, dated 7/10/24, identified no duplicate drug therapy. The agency failed to identify duplicate bowel medications, supplements, coagulation agents and central nervous system medications. 5. Patient #8 had a start of care date of 7/16/24. Clinical record revealed the following: a. The POC, dated 7/16/24 to 9/13/24, included medication orders for Acetaminophen and oxycodone (pain medications), Docusate sodium and Miralax (bowel medications), and Bupropion, Buspirone, Gabapentin, Hydroxyzine, Lamictal, Rexulti and Venlafaxine (central nervous system agents). b. The Drug Regimen Review form, dated 7/16/24, identified no duplicate drug therapy. The agency failed to identify duplicate bowel medications and central nervous system medications. 3. Patient #3 had a start of care date of 8/2/24. Clinical record revealed the following: a. The Plan of Care, dated 8/2/24 to 9/30/24, included medication orders for metoprolol succinate and valsartan (blood pressure medications); and protonix and famotidine (stomach acid reducers). b. The Drug Regimen Review form, dated 8/5/24, identified no duplicate drug therapy. Findings Include: According to the agency policy titled Medication Profile, dated January 2023, A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication. The review will be performed by qualified personnel and will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy, and noncompliance with drug therapy. During agency staff interview on 8/12/24 at 1:00pm, Staff E, Registered Nurse, stated that she looks at the medication profile for any issues at admission, recertification and with any major changes with medications and let the physician know if there is any issues noted. 1. Patient #2 had a start of care date of 9/29/23. Clinical record review revealed the following: a. Plans of Care, dated 9/29/23 to 11/27/23, 11/28/23 to 1/26/24, 1/27/24 to 3/26/23, 3/27/24 to 5/25/24, and 5/26/24 to 7/24/24 included medication orders for Keppra, Tizanidine, Baclofen and Dantrolene sodium, (medications used to treat muscle spasms) b. The Drug Regimen Review forms, dated 9/29/23, 1/22/24, 5/23/24, 7/20/24 and 7/26/24, identified no duplicate drug therapy. The drug regimen review failed to identify the duplicate medications for muscle spasms. 2. Patient #6 had a start of care of 5/15/2019. Clinical record revealed the following. a. The plans of care dated,12/20/23 to 2/17/24, 2/18/24 to 4/17/24, 4/18/24 to 6/15/24 included medication orders for Atenolol, (blood pressure), Cetirizine, (antihistamine) , Sertraline (antidepressant) and Insulin (medication injected for diabetes control) b. The Drug Regimen Review forms dated, 12/18/23, 2/15/24, 3/14/24 and 5/3/24 identified no potential medication interactions. c. Patient #6 was discharged from the agency on 5/24/24, the clinical record lacked completion of a Drug Regimen Review at the time of discharge. The agency failed to complete the Drug Regimen Review at discharge and failed to identify potential medication interaction with the Drug Regimen Reviews completed in the clinical record.

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 home visit observations, patient interviews, clinical record reviews, and agency policy reviews, the agency failed to ensure the accurate completion of all components comprising the Plan of Care, including all supplies/equipment and medications used by the patient for 2 of 3 home visit observations (Patients #2 and #3). Failure to maintain complete and accurate Plans of Care with current orders placed the patients at risk to not receive services, medications, supplies, and/or treatments according to assessed needs and physician orders. Findings include: 2. Patient #2 had a start of care date of 9/29/23. Clinical review revealed the following. a. The Plan of Care (POC) dated, 9/29/23 to 11/27/23, included the following durable medical equipment (DME) used by the patient: a bedside commode, cane, dressing supplies, grab bars, hospital bed, respiratory equipment, slider board, tub/shower bench, wheelchair, diabetic supplies, dressing supplies and exam gloves. b. During a home visit observation on 8/12/24 at 12:20 PM, with Staff E, Registered Nurse (RN), the surveyor identified the following additional DME in the home: reacher. During this same visit, the patient was observed using the reacher throughout the visit and during a patient interview indicated he is not able to move his legs without using the reacher. The agency failed to include all of the DME required by the patient on the plan of care. The agency provided no additional information prior to the end of the survey. According to the agency policy titled Care Planning Process, dated January 2021, a written plan of care will be initiated within five days of the start of care and updated at least every 60 days or as patient's condition warrants. The clinical plan of care includes but is not limited to the following: medications including dose/frequency/route, supplies and equipment required, frequency and duration of visits, prognosis, rehabilitation potential and nutritional requirements. 1.Patient #3 had a start of care date of 8/2/24. Clinical record review revealed the following: a. The Plan of Care (POC), dated 8/2/24 to 9/30/24 included the following medications: Voltaren Gel apply topical cream to painful area, Systane-solution one drop in each eye twice a day, Hydroxyzine 20 milligrams (mg) take one tablet twice a day as needed, Meclizine 25mg take one tablet two times a day as needed, Famotidine 20mg take one tablet at bedtime as needed, Ezetimibe 10mg take one tablet at bedtime, Furosemide 20mg take one tablet at 8:00 AM, Metformin 500mg take one tablet at 8:00 AM and 8:00 PM, Eliquis 5mg take one tablet at 8:00 AM and one tablet at 8:00 PM, Valsartan 80mg take one tablet at 8:00 PM, Protonix 40mg take one tablet at 8:00 AM, Metoprolol Succinate 50mg take one tablet at bedtime and Metoprolol Succinate 100mg take one tablet at 8:00 AM. b. During a home visit observation on 8/13/24 at 3:15 PM, with Staff F, Physical Therapy Assistant (PTA), an interview with the patient revealed the patient is taking Tylenol 500mg as needed, metamucil fiber gummies twice a day and Vitamin D3 50 micrograms (mcg) three tablets every morning. The surveyor observed the patient's hydroxyzine was last refilled on 1/29/24 and the dose is 25mg with instructions to take one tablet by mouth three times a day. c. The POC included the following durable medical equipment (DME) used by the patient: Eye glasses, dentures, medtronic pacer, life alert, diabetic supplies, wheeled pushcart and grab bars. d. During a home visit observation on 8/13/24 at 3:15 PM, with Staff F, PTA, the surveyor identified the following additional DME in the home: blood pressure cuff. During this same visit, an interview with the patient revealed the blood pressure cuff has been utilized by the patient for a long time due to the patient's fluctuating blood pressures. The POC failed to include correct medications and all DME the patient required for use.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on agency staff interview, home visit observation, patient/ caregiver interview and admission packet review, the agency failed to provide agency patients with written medication schedule/instructions, including: medication name, dosage and frequency. The agency failed to provide this information for 1 of 3 sampled patients with home visits (Patient #3). The agency reported a census of 58 patients at the time of the survey. Failure to provide the medication schedule/instructions left the patients without the needed information to administer the correct dosage at the correct times and put the patient at risk for medication administration errors. Findings include: According to the agency policy titled Medication Profile, dated January 2021, each patient will receive appropriate written material for specific medications he/she is receiving. The material will contain information on actions of the medication, potential side effects, contraindications the patient should be aware of and any special instructions when taking the medication. Patient #3 had a start of care date of 8/2/24 and received skilled nursing, home health aide, physical therapy, and occupational therapy services from the agency. On 8/13/24 at 3:15 PM, during a home visit observation with Staff F, Physical Therapy Assistant (PTA), the patient revealed the patient did not have a current medication list in her home. The pharmacy fills the patient's medication box and has a list taped to the bottom of the box that only included scheduled medications. The agency failed to provide the patient and caregiver with a copy of written instructions outlining the patient's medication schedule and instructions. The findings were reviewed with the Administrator, Human Resource Manager, Corporate Liaison, Staff C, Nursing Supervisor and Staff D, Nursing Supervisor.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on agency staff interview, home visit observation, patient/ caregiver interview and admission packet review, the agency failed to provide agency patients with written information on any treatments to be administered by agency personnel acting on behalf of the agency, including therapy services. The agency failed to provide this information for 1 of 3 sampled patients with home visits (Patient #3). Failure to provide the patient with written information on treatments administered by the agency put the patient at risk for not receiving the ordered treatments including therapy services. Findings include: Patient #3 had a start of care date of 8/2/24 and received skilled nursing, home health aide, physical therapy, and occupational therapy services from the agency. On 8/13/24 at 3:15 PM, during a home visit observation with Staff F, Physical Therapy Assistant (PTA), Staff F performed her visit. The patient identified the only information provided by the agency was in the admission folder. Review of the admission folder revealed the patient was not given any written instructions outlining the treatments and therapy services being provided. The agency failed to ensure the patient had written instructions outlining the treatments and services being provided. The above findings were reviewed with the Administrator, Human Resource Manager, Corporate Liaison, Staff C, Nursing Supervisor and Staff D, Nursing Supervisor.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review, staff and patient interview, the agency failed to ensure home health aides provided care to agency patients only as ordered by the physician, permitted under state law and/or as directed by the skilled professional assigning the home health aide to the patient for 1 of 3 sampled patients receiving home health aide services (Patients #7). Failure to ensure that home health aide services are provided only as ordered by the physician, permitted under state law and/or as directed by the skilled professional assigning the home health aide to the patient and according to the home health aide care plan increased the risk that patients' personal care needs were not adequately met. Findings include: Patient #7 had a start of care date of 8/30/23 and a discharge date of 12/15/23. Clinical record review revealed the following: a. The Plans of Care, dated 8/30/23 to 10/28/23 and 10/29/23 to 12/27/23, included physician orders for skilled nursing visits once a week and home health aide visits twice a week. b. The home health aide assignment, dated 8/31/23, directed the aides to assist the patient with personal care including shower, partial sponge bath, complete sponge bath, shampoo, lotion and passive range of motion. Instructions included patient is capable of making own decisions in regards to cares. c. The home health aide assignment, dated 10/30/24, directed the aides to assist the patient with personal care including shower, partial sponge bath, complete sponge bath, shampoo, lotion, passive range of motion, and standby assist in and out of shower. Instructions included patient is capable of making own decisions in regards to cares. d. The home health aide visit notes, dated 10/16/23 and 10/19/23, included documentation partial sponge bath was completed but lacked documentation regarding the tasks of shower, complete sponge bath and shampoo hair. e. The home health aide visit notes, dated 11/3/23, 11/7/23 and 11/14/23, included documentation partial sponge bath was completed but lacked documentation regarding the tasks of shower, complete sponge bath, shampoo hair and standby assist in and out of shower. f. The home health aide visit note, dated 11/10/23, included documentation shower and shampoo hair was completed but lacked documentation regarding the tasks of partial sponge bath, complete sponge bath and lotion. g. The home health aide visit note, dated 11/21/23, included documentation partial sponge bath was completed but lacked documentation regarding the tasks of shower, complete sponge bath, shampoo hair, lotion and standby assist in and out of shower. The home health aide failed to follow the aide care plan as directed or document why the care plan was not followed. The agency provided no additional information prior to the end of the survey. According to the agency policy titled Home Health Aide Plan of Care, dated 1/2021, the patient's Case Manager, upon initialization of aide services, will develop the home health aide plan of care, consistent with the comprehensive plan of care and physician (or other authorized licensed independent practitioner) orders. The Case Manager or other appropriate clinician will supervise the home health aide at least every 14 days or every 60 days(depending on services of the client) to ensure care is provided according to plan. During an interview on 8/12/24 at 3:30 PM, Staff C, Nurse Supervisor stated the home health aide to notify the nurse if unable to complete a task. If a task requested not on the care plan, the aide to call the nurse so they can add the task to the care plan.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review and staff interview, the agency failed to ensure the clinical record included the patient's current documentation and a complete chart for 3 of 8 sampled patients (Patients #1, #5 and #8). Failure of the agency to ensure the clinical record included current documentation placed agency patients at risk to receive care or not receive care meeting the needs of the patient. Findings include: 3. Patient #1 had a start of care date of 2/23/21. Clinical record review revealed the following: a. The recertification comprehensive assessments, dated 6/3/24 and 8/5/24, were completed but lacked documentation of a drug regimen review. b. The document section of the electronic medical record lacked documentation of scanned drug regimen review forms for the dates of 6/3/24 and 8/5/24. During an interview on 8/13/24 at 9:30 AM, Staff B, Human Resource Manager, reported talking with Staff C, RN Supervisor, who was able to find the drug regimen review forms dated 6/3/24 and 8/5/24 in her email. Staff C unsure why the forms had not been uploaded into the electronic medical record. Paper copies of the forms were provided to the surveyor for review. The agency failed to upload all clinical documentation timely as required per agency expectation. The agency provided no additional information prior to the end of the survey. According to the agency policy titled Clinical/Service Data Collection, dated 1/2021, entries into the clinical/service record will be made on the day care/service is provided to the patient. All documentation will be turned into the office or electronically submitted within 72 hours of the date of the visit. Filing of visit must be done within 10 days from the date of the visit. 1. Patient #5 had a start of care date of 7/10/24. Clinical record review revealed the following: a. The start of care comprehensive assessment, dated 7/10/24, completed but lacked documentation of a drug regimen review. b. The document section of the electronic medical record lacked documentation of scanned drug regimen review forms for the dates of 7/10/24. During an interview on 8/13/24 at 9:30 AM, Staff B, Human Resource Manager, reported talking with Staff C, RN Supervisor, who was able to find the drug regimen review forms dated 8/13/24 in her email. Paper copies of the forms were provided to the surveyor for review. The agency failed to upload all clinical documentation timely as required per agency expectation. 2. Patient #8 had a start of care date of 7/16/24. Clinical record review revealed the following: a. The plan of care, dated 7/16/24 to 9/13/24, included orders for skilled nursing, physical therapy and occupational therapy. b. The document section of the electronic medical record lacked documentation of physical therapy or occupational therapy visit notes. c. During an interview on 8/13/24 at 1:20 PM, Staff B, Human Resource Manager, reported the agency office manager responsible to log into the contracted therapy system and upload the visit notes into the agency electronic medical record. She further stated the office manager failed to complete the task. The physical therapy and occupational therapy documents retrieved and handed to the surveyor for review. The agency failed to upload all clinical documentation timely as required per agency expectation.

The recertification survey, dated 8/9/21 to 8/12/21, identified the home health agency was found to be in substantial compliance in relation to emergency preparedness regulations.

The Department of Inspections and Appeals conducted a COVID-19 Focused Infection Control Survey in conjunction with with a recertification survey, from 8/9/21 through 8/12/21. The survey found the agency was operating out of compliance with the following Home Health Conditions of Participation: 1) Condition of Participation 42 CFR 484.60: Care Planning, Coordination and Quality of Care (see G0572, G574 and G580); 2) Condition of Participation 42 CFR 484.65: Quality Assessment and Performance Improvement (see G0640, G0642, G0644, G0648, G0650, G0652, G0654, G0656, G0658 and G0660). The agency was found to be in compliance with CMS and Centers for Disease Control and Prevention (CDC) recommended practices to prepare for COVID-19. As a result of the agency's noncompliance with the Medicare Conditions of Participation for home health agencies, the home health agency and its registered nurses are prohibited from providing basic skills competency training, and prohibited from providing evaluation of home health aide written basic skills testing and evaluation of demonstrated competency of the hands on basic skills for the agency's home health aides for 2 years, beginning on 8/12/21 and ending on 8/12/23.

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 clinical record review and staff interview, the agency failed to ensure agency staff ensured the patient participated in, informed about and had consent or refused care in advance of and during treatment before the agency initiated care for 1 of 11 sampled patients (Patients 3). The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Failure to ensure agency staff ensured the patient participated in, informed about and had consent or refused care in advance of and during treatment before the agency initiated care before the agency initiated care placed agency patients at risk for the patient's rights being violated and services provided without consent. Findings include: According to the agency policy titled Admission Criteria and Process, dated January 2018, the patient or his/her representative will sign the required forms indicating acceptance of services and receipt of patient rights and privacy information. Patient #3 had a start of care date of 6/23/21 and received services out of the Cedar Rapids office. The Plan of Care (POC), dated 6/23/21 to 8/21/21, included orders for skilled nursing services. Review of the clinical record lacked documentation of completed consent forms. During an observational home visit on 8/11/21 at 10:00 AM with Staff O, RN (Registered Nurse) the surveyor reviewed the agency folder and identified consent forms in the folder without patient or caregiver signatures. The Administrator, Clinical Manager and Office Manager received the above findings for patient #3 and agency staff provided no further information prior to the end of the survey.

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 clinical record review, agency policy review the agency failed to provide an initial assessment visit within 48 hours of receipt of referral and/or return home, for 1 of 11 sampled patients (Patients #3). The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Failure to provide an initial assessment visit within 48 hours put agency patients at risk for not having immediate care needs met. Findings include: According to the agency Policy titled Initial and Comprehensive Assessment, dated January 2018, and initial patient assessment will be performed and documented in the patient's clinical record by a registered nurse, physical therapist or speech therapist. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient's return home, on the start of care date ordered by the physician. Review of the clinical records indicated the following: Patient #3 had a start of care date of 6/23/21 and received services out of the Cedar Rapids office. The Plan of Care (POC), dated 6/23/21 to 8/21/21, included orders for skilled nursing services. Patient #2's initial assessment, dated 6/23/21, had been completed 3 days after their referral date of 6/18/21, exceeding the required time allowed by 3 calendar days. The agency staff failed to complete an initial assessment on the patients within 48 hours of referral. The Administrator, the Clinical Manager and the Office Manager received the above findings for patient #3 and agency staff provided no further information prior to the end of the survey.

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, agency policy review and agency staff interview, the agency failed to complete a drug regimen review, including all required components, with each comprehensive assessment within the allowed timeframe for 5 of 10 sampled patients (Patients #4, #5, #6, #8 and #9). The agency reported a current census of 273 patients at the time of the survey, including 52 patients who received services from the Cedar Rapids parent office, 56 patients who received services from the Cedar Falls branch office, 31 patients who received services from the Coralville branch office, 55 patients who received services from the Davenport branch office, 54 patients who received services from the Dubuque branch office, and 26 patients who received services from the Irving Point branch office. The deficient practice was identified at Cedar Falls, Coralville, Davenport and Dubuque branch offices. Failure to ensure medications reviewed at the time of each drug regimen review are current and accurate increased the potential for unidentified medication interactions and side effect risks to the patient. Findings include: The agency policy, titled Medication Profile, dated 01/2018, included a Drug Regimen Review will be performed at the time of admission, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication. 1. Patient #9 had a start of care date of 4/25/17, a discharge date of 2/8/21, and received services from the Cedar Falls branch office. Clinical record review revealed the Recertification of care comprehensive assessment, dated 1/29/21, lacked documentation a drug regimen review (DRR) had been completed. During an interview on 8/11/21 at 2:00 PM, the Director of Human Resources reported she would contact the branch office for documentation of missing DRRs. On 8/11/21 at approximately 3:00 PM, the surveyor was presented with a list of completed DRRs, the list failed to include the DRR for 1/29/21. 2. Patient #4 had a start of care date of 10/15/2020. The Plans of Care (POC), dated 4/13/21 to 6/11/21 and 6/12/21 to 8/10/21, included orders for skilled nursing services. The comprehensive assessment, completed at recertification of care, dated 6/8/21, documented the medication profile was reviewed and no issues found during review.. The Drug Regimen Review, dated 10/15/20, 2/11/21 and 4/8/21, revealed no documentation of drug regimen review completed. 3. Patient #5 had a start of care date of 7/27/21 and received home health services from the Davenport branch office. On 8/9/21 at 2:10 PM, during a home visit observation with Staff H, RN from the Davenport office, the surveyor observed the patient had a container of Biofreeze, an over the counter topical pain relief medication. In an interview, during the same home visit observation the patient reported use of Biofreeze daily as needed for the last couple years. b. The clinical record lacked documentation of a physician's order for the Biofreeze. c. The DRR completed with the comprehensive assessment, dated 7/27/21, failed to include the Biofreeze medication. 4. Patient #6 had a start of care date of 7/24/17 and received home health services from the Coralville branch office. On 8/10/21 at 2:06 PM, during a home visit observation with Staff I, Physical Therapy Assistant, the surveyor observed a half used bottle of Tums, an over the counter medication used to treat stomach upset. In an interview during the same home visit observation, the patient reported using Tums 2 tablets as needed daily for several years. The patient also reported use of Biofreeze for the last couple months as needed for pain. Review of the clinical record revealed the following: a. The POC, dated 7/3/21 to 8/31/21, included physician orders for medications, but lacked an order for Tums and Biofreeze. b. The clinical record lacked documentation of an order for Tums and Biofreeze. c. A skilled nursing visit note, dated 7/30/21, included documentation the patient reported using a topical over the counter pain medication (Biofreeze). d. The DRR completed with the update to the comprehensive assessment (recertification), dated 6/30/21, lacked the inclusion of Tums and Biofreeze. 5. Patient #8 had a start of care date of 7/10/2020 and received home health services from the Dubuque branch office. Review of the clinical record revealed the following: a. The POCs, dated 3/7/21 to 5/5/21 and 5/6/21 to 7/4/21, included physician orders for medications. b. The update to the comprehensive assessment completed at the time of recertification, dated 5/4/21, indicated the nurse had completed a DRR. The clinical record included documentation of a DRR on 3/2/21 and then the next subsequent DRR on 5/21/21. The nurse completed the DRR 16 days late. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

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 clinical record review, agency staff interview, review of the agency's Outcome and Assessment Information Set (OASIS) Validation Reports and agency policy review, agency clinicians failed to complete updates to the comprehensive assessment at recertification in the last 5 days of each certification period for 2 of 7 sampled patients requiring a recertification assessment (Patients #1 and #2). The agency reported a current census of 273 patients, including 52 patients served through the parent office in Cedar Rapids, 56 patients served through the Cedar Falls branch office, 31 patients served through the Coralville branch office, 54 patients served through the Dubuque office, 55 patients served through the Davenport branch office and 26 patients served through the Irving Point branch office. The survey identified the deficient practice occurred at the Dubuque and Irving Point branch offices. Failure to complete the updates to the comprehensive assessment at recertification in a timely manner increased the potential that patients might not receive services in a timely manner according to assessed needs. Findings include: Review of the agency policy, titled Reassessment/Recertification, dated 1/2018, clinicians must complete the update to the comprehensive assessment at recertification no earlier than five days before and no later than one day before the calendar day on which the new episode of care will begin. The completion of the update of the comprehensive assessment at the time of recertification must include all follow up data items of the OASIS. On 8/11/21 at 11:28 AM, during an interview, the Clinical Supervisor for the Dubuque and Iving Point office reported she competes audits and tracks the completion of assessments to ensure timeliness. On 8/12/21, review of the agency's OASIS Validation Reports from May 2021 through 8/10/21 (last submission reported on 7/27/21) revealed 20 agency patients receiving the following error message: "Record timing invalid: CMS guidelines require recertification follow up records at least every 60 days, but no earlier than day 56 of the follow up cycle." 1. Patient #2 had a start of care date of 5/7/19 and received home health services from the Dubuque branch office. Review of the clinical record revealed the following: a. The Plan of Care (POC), dated 12/27/2020 to 2/24/2021, included orders for home health services and medications. b. The update to the comprehensive assessment, dated 2/24/21, included documentation of a signature of completion, dated 2/25/21. The nurse completed the assessment 1 day late. 2. Patient #1 had a start of care date of 5/15/2019 and received services from the Irving Point branch office. Clinical record review revealed: a. The POC, dated 5/3/2021 to 7/1/2021, included orders for home health services, medications and incorrect recertification dates. The correct dates should have read, 5/4/2021 to 7/2/2021. Day 56 of the certification period was 6/28/21. b. The update to the comprehensive assessment, dated 6/27/21, included documentation of a signature of completion, dated 6/27/21. The nurse completed the assessment 1 day early. The above findings for Patients #1 and #2 were reviewed with agency Director of Human Resources, Office Manager for Cedar Rapids parent office and the Clinical Supervisor for Irving Point and Dubuque branch offices. Agency staff provided no further information prior to the end of the survey.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on clinical record review, agency policy review, patient interview and agency staff interview, the agency: 1) failed to ensure agency staff followed the plan of care in the delivery of services and alerted the physician to changes in the plan of care (G0572); 2) failed to ensure the Plan of Care accurately reflected recertification dates, care, treatment and services provided to the patient (G0574); and, 3) failed to ensure agency staff administered drugs, services, and treatments only as ordered by a physician (G0580). The cumulative systemic practices resulted in the failure to ensure the organizational framework of the agency promoted and supported the coordination of safe and effective delivery of care to the agency's 273 patients.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on clinical record review, agency policy review and agency staff interview, the agency failed to follow a Plan of Care established and periodically reviewed by a doctor of medicine, osteopathy or podiatry or notify the physician of the need to vary from the physician ordered Plan for Care for 3 of 10 sampled patients (Patients #4, #5 and #6). The agency reported a current census of 273 patients, including 52 patients served through the parent office in Cedar Rapids, 56 patients served through the Cedar Falls branch office, 31 patients served through the Coralville branch office, 54 patients served through the Dubuque office, 55 patients served through the Davenport branch office and 26 patients served through the Irving Point branch office. The survey identified the deficient practice occurred at the Davenport, Coralville and Cedar Falls branch offices. Failure to follow a Plan of Care established by a physician placed patients at risk of not receiving safe, individualized and consistent care designed to meet each patient's health care needs. Findings include: Review of the agency's policy, titled Care Planning Process, dated 1/2018, revealed clinical staff will develop the Plan of Care (POC) within 5 days of the start of care and updated at least every 60 days. The POC will include orders for specific home health services and disciplines including amount, frequency and duration. Agency staff will provide services based on a physician approved POC. The frequency of the review of the POC will be based on changes in the patient's needs, health status and environmental changes. Any changes to the POC will include a physician's order. The clinician will notify the patient's physician of any changes that suggest a need to alter the POC. If a missed visit occurs for any discipline, agency staff must complete a missed visit report and fax the report to the patient's physician. On 8/9/21 at 10:06 AM, during an interview, Staff G, Clinical Supervisor for the Davenport office reported the expectation agency staff will document all verbal orders on the same day they occur. On 8/11/21 at 11:28 AM, during an interview, Staff F, Clinical Supervisor for the Irving Point branch offices reported the expectation staff document verbal orders right away. 1. Patient #5 had a start of care date of 7/27/21 and received home health services from the Davenport branch office. Review of the clinical record on 8/9/21 revealed the following: The POC, dated 7/27/21 to 9/24/21, included orders for skilled nursing services 3 times per week and home health aide services 2 times per week. a. The week of 7/27/21 included documentation of 4 skilled nursing visits, dated 7/27, 7/28, 7/30 and 7/31/21. The clinical record lacked documentation of a physician's order for 4 skilled nursing visits the week of 7/27/21. b. The week of 8/1/21 included documentation of 3 home health aide visits, dated 8/2, 8/5 and 8/6/21. The clinical record lacked documentation of a physician's order for 3 home health aide visits the week of 8/1/21. On 8/9/21 at 12:39 PM, during an interview, the Clinical Supervisor for the Davenport office and interim Clinical Supervisor for the Coralville office reported she would have to ask the nurse, Staff H, Registered Nurse (RN) for the Davenport office, about the extra nursing visit. She reported she would look into the extra aide visit the week of 8/1/21. On 8/9/21 at 12:51 PM, during an interview, Staff G reported agency staff made a mistake and provided an extra home health aide visit the week of 8/1/21. On 8/9/21 at 1:13 PM, during an interview, Staff H, RN for the Davenport office, explained she got an order for the extra skilled nursing visit on 7/31/21 to provide wound care. She forgot to put the order in the system, but explained the physician's order was in the patient's record now. Review of the physician's order, dated 8/9/21 as a late entry, included documentation of an order to perform wound care on a new skin tear on the patient's right forearm. The order lacked a date and time the nurse took the order and lacked any mention of providing an extra skilled nursing visit to complete the wound care. 2. Patient #6 had a start of care date of 7/24/17 and received home health services from the Coralville branch office. Review of the clinical record on 8/10/21 revealed the following: a. The POC, dated 5/4/21 to 7/2/21, included orders for skilled nursing services 2 times per week. b. An interim physician order, dated 5/12/21, included order to decrease skilled nursing visits to 1 time per week. c. Review of the clinical record revealed a lack of documentation of skilled nursing visit the week of 6/13/21. The clinical record lacked documentation of a missed visit report or notification of the patient's physician of a missed visit. On 8/10/21 at 10:50 AM, during an interview, the surveyor notified Staff G, of an inability to find a skilled nursing visit in the record or a missed visit report for the week of 6/13/21. On 8/10/21 at 11:20 AM, during an interview, Staff G, the Clinical Supervisor for the Davenport office reported agency staff had not completed a missed visit report and sent this to the patient's physician until after the surveyor notified her of the missed visit today. 3. Patient #4 had a start of care date of 10/15/2020. Clinical record review revealed: a. A Plan of Care, dated 6/12/21 to 8/10/21, included physician orders for skilled nursing services 1 time a week for 9 weeks. b. The clinical record lacked documentation of a skilled nurse visit for the week of 7/18/21 through 7/24/21. c. A Canceled/Missed Visits Report, dated 7/22/21, included physician notification of a missed home health aide visit but failed to identify a skilled nurse visit. The above stated findings were reviewed with the agency Administrator, Clinical Manager and Office Manager. The agency provided no additional information prior to the end of the survey.

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 clinical record review, agency policy review, home visit observation, patient interview and agency staff interview, the agency failed to ensure the accurate completion of all components comprising the Plan of Care, including all supplies/equipment used by the patient and accurate recertification dates for 3 of 10 sampled patients (Patients #1, #5 and #6). The agency reported a current census of 273 patients at the time of the survey, including 52 patients who received services from the Cedar Rapids parent office, 56 patients who received services from the Cedar Falls branch office, 31 patients who received services from the Coralville branch office, 55 patients who received services from the Davenport branch office, 54 patients who received services from the Dubuque branch office, and 26 patients who received services from the Irving Point branch office. The deficient practice was identified at Davenport and Irving Point branch offices. Failure to maintain complete and accurate Plans of Care with current orders placed the patients at risk to not receive services, medications and/or treatments according to assessed needs and physician orders. Findings include: According to agency policy, titled Care Planning Process, dated 1/2018, the clinical plan of care includes certification period, supplies and equipment required. 1. Patient #1 had a start of care date of 5/15/2019 and received services from the Irving Point branch office. Clinical record review revealed: a. The Plan of Care, dated 9/6/2020 to 11/4/2020, included physician orders for skilled nursing and home health aide services. b. The Plan of Care, dated 11/4/2020 to 1/2/2021, included incorrect recertification dates. The correct dates should have read, 11/5/2020 to 1/3/2021. c. The Plan of Care, dated 1/3/2021 to 3/3/2021, included incorrect recertification dates. The correct dates should have read, 1/4/2021 to 3/4/2021. d. The Plan of Care, dated 3/4/2021 to 5/2/2021, included incorrect recertification dates. The correct dates should have read, 3/5/2021 to 5/3/2021. e. The Plan of Care, dated 5/3/2021 to 7/1/2021, included incorrect recertification dates. The correct dates should have read, 5/4/2021 to 7/2/2021. f. The Plan of Care, dated 7/2/2021 to 8/30/2021, included incorrect recertification dates. The correct dates should have read, 7/3/2020 to 8/31/2021. The agency failed to include accurate information on the individualized plan of care per regulation.2. Patient #5 had a start of care date of 7/27/21 and received home health services from the Davenport branch office. On 8/9/21 at 2:10 PM, during a home visit observation with Staff H, RN from the Davenport office, the surveyor observed the patient had a container of Biofreeze, an over the counter topical pain relief medication. The surveyor also observed the patient had a personal emergency response button and wheelchair cushion. In an interview, during the same home visit observation the patient reported use of Biofreeze daily as needed for the last couple years. The patient reported the patient had been using the personal emergency response button and wheelchair cushion for the last couple years. Review of the clinical record revealed the following: The Plan of Care (POC), dated 7/27/21 to 9/24/21, failed to include Biofreeze in the listed medications used by the patient and failed to identify the patient used a wheelchair cushion and personal emergency response button. 3. Patient #6 had a start of care date of 7/24/17 and received home health services from the Coralville branch office. On 8/10/21 at 2:06 PM, during a home visit observation with Staff I, Physical Therapy Assistant, the surveyor observed a half used bottle of Tums, an over the counter medication used to treat stomach upset. In an interview during the same home visit observation, the patient reported using Tums 2 tablets as needed daily for several years. The patient also reported use of Biofreeze for the last couple months as needed for pain. Review of the clinical record revealed the following: The POC, dated 7/3/21 to 8/31/21, failed to include Biofreeze and Tums in the listed medications used by the patient. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

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, agency policy review and agency staff interview, the agency staff failed to provide medications and treatments only as ordered by the physician for 6 of 10 sampled patients (Patients #1, #3, #4, #5, #6 and #7). The agency reported a current census of 273 patients, including 52 patients served through the parent office in Cedar Rapids, 56 patients served through the Cedar Falls branch office, 31 patients served through the Coralville branch office, 54 patients served through the Dubuque office, 55 patients served through the Davenport branch office and 26 patients served through the Irving Point branch office. The survey identified the deficient practice occurred at the Cedar Rapids parent office and Davenport, Coralville, Irving Point and Cedar Falls branch offices. Failure to ensure staff obtain/follow physician orders for administration of medications and treatments placed agency patients at risk for inconsistent care/treatment and possible harm. Findings include: Review of the agency's policy, titled Care Planning Process, dated 1/2018, revealed clinical staff will develop the Plan of Care (POC) within 5 days of the start of care and updated at least every 60 days. The POC will include orders for specific home health services and disciplines including patient specific treatments and procedures. Agency staff will provide services based on a physician approved POC. The frequency of the review of the POC will be based on changes in the patient's needs, health status and environmental changes. Any changes to the POC will include a physician's order. The clinician will notify the patient's physician of any changes that suggest a need to alter the POC. On 8/9/21 at 10:06 AM, during an interview, the Clinical Supervisor for the Davenport office reported the expectation agency staff will document all verbal orders on the same day they occur. 1. Patient #7, a pediatric patient, had a start of care date of 7/19/21 and received home health services from the Coralville branch office. Review of the clinical record revealed the following: a. The POC, dated 7/19/21 to 9/16/21, identified the patient had a diagnosis of a brain tumor and included orders for weekly skilled nursing visits for the nurse to change the patient's central line intravenous (IV) dressing. The POC included an order for a Heparin flush 10 Units daily via IV and no the other flush orders. b. The summary to the physician on the POC completed with comprehensive assessment at the start of care, dated 7/19/21, included documentation the nurse had changed the patient's central line dressing and the line "flushed without concern". c. The skilled nursing visit, dated 7/26/21, included documentation the nurse, Staff G, Clinical Supervisor for the Davenport office/Interim Clinical Supervisor for the Coralville office, completed a 5 milliliter (ml) flush with a dressing change on the central line to verify patency. d. The clinical record lacked documentation of an order to flush the patient's central line with Normal Saline. On 8/10/21 at 11:42 AM, during an interview, the Clinical Supervisor for the Davenport office/Interim Clinical Supervisor for the Coralville office reported she flushed the patient's central line with 5 ml of Normal Saline at both the visit at the start of care, dated 7/19/26, and again on 7/26/21. She explained the patient had 10 ml pre-filled syringes of Normal Saline in the home, but she only used 5 ml each time to due the smallness of the central line. The patient's primary caregiver gives the patient the Heparin flush at night. She thought maybe the discharge orders from the hospitalization prior to the patient's admit to the home health agency had an order for a Normal Saline flush and agreed to look for this order. She reported she forgot to put the order on the POC. On 8/11/21 at 1:20 PM, during an interview, the Clinical Supervisor for the Davenport office/Interim Clinical Supervisor for the Coralville office reported an inability to find any orders for the Normal Saline flush. 2. Patient #5 had a start of care date of 7/27/21 and received home health services from the Davenport branch office. Review of the clinical record on 8/9/21 revealed the following: The POC, dated 7/27/21 to 9/24/21, included orders for skilled nursing services 3 times per week. a. The week of 7/27/21 included documentation of an extra skilled nursing visit, dated 7/31/21. Staff H, Registered Nurse (RN) for the Davenport office, documented she completed wound care to skin tear on the left arm. She documented she cleansed the wound with Normal Saline and covered the wound with dry gauze and Kerlix (a type of wrap gauze). b. The week of 8/1/21 included documentation of 3 skilled nursing visits, dated 8/2, 8/4 and 8/6/21. The visit, dated 8/2, included documentation the Clinical Supervisor for the Davenport office and Interim Clinical Supervisor for the Coralville office described the wound bed as "red/brown". The visit, dated 8/4, included documentation Staff H, RN for the Davenport office, described the wound bed as pink with granulation tissue (healing). Both nurses documented they cleansed the left arm wound with Normal Saline and covered the wound with dry gauze and Kerlix. The skilled nursing visit, dated 8/6/21, included documentation the Clinical Supervisor for the Davenport office and Interim Clinical Supervisor for the Coralville office cleansed the left arm wound with Normal Saline and left the wound open to air. c. The clinical record lacked documentation of a physician's order for wound care treatment to the left arm. On 8/9/21 at 12:39 PM, during an interview, the Clinical Supervisor for the Davenport office/ interim Clinical Supervisor for the Coralville office reported she would have to ask the nurse, Staff H, Registered Nurse (RN) for the Davenport office, about the extra nursing visit on 7/31/21. On 8/9/21 at 1:13 PM, during an interview, Staff H, RN for the Davenport office, explained she got an order for the extra skilled nursing visit on 7/31/21 to provide wound care. She forgot to put the order in the system, but explained the physician's order was in the patient's record now. Review of the physician's order, dated 8/9/21 as a late entry, included documentation of an order to perform wound care on a new skin tear on the patient's right (not left) forearm by applying a non-adherent pad and wrap with gauze. The nurses failed to follow wound care orders by applying a non-adherent pad to the wound and used Normal Saline to cleanse the wound without specific orders. On 8/9/21 at 2:10 PM, during a home visit observation, Staff H, RN for the Davenport office, looked at a scabbed area on the the patient's left forearm. She reported the area was healed and no longer required a wound dressing. She reported a plan to contact the patient's physician today to get the order for wound care to the left arm skin tear discontinued. During the same home visit observation, Staff H, RN for the Davenport office, donned gloves and removed the patient's right sock. The surveyor observed the patient had a Mepilex dressing on the right great toe. The nurse removed the Mepilex and Silver Alginate from the right great toe. She then removed her gloves, sanitized her hands and donned another pair of gloves. Staff H, RN for the Davenport office, cleansed the right great toe wound with sterile water, applied Silver Alginate and covered the wound with a wrap gauze. The nurse put the patient's sock back on and nothing else. Review of the clinical record revealed the following interim physician order for wound care to the right great toe, dated 8/4/21, apply Alginate with Silver three times weekly and instruct patient to wear post op shoe. The wound care provided by the agency nurse on 8/9/21 did not match the order given by the physician. On 8/10/21 at 9:33 AM, during an interview, the Clinical Supervisor for the Davenport office/Interim Clinical Supervisor for the Coralville office reported she should have gotten updated orders to discontinue the wound care on the patient's skin tear. She reported she forgot to include Mepilex in the order for the right great toe along with the Silver Alginate, as this is what the wound clinic was using to treat the wound. She provided documentation of a communication note to the patient's physician, dated 8/6/21, which included a request to send a wound supply prescription to the pharmacy and include in the prescription Silver Alginate and Mepilex or dressing of choice. 3. Patient #6 had a start of care date of 7/24/17 and received home health services from the Coralville branch office. Review of the clinical record revealed the following: a. The POC, dated 5/4/21 to 7/2/21, identified a diagnosis of paralytic syndrome and included orders for the skilled nurse to complete a comprehensive assessment and full set of vitals every visit. b. The skilled nursing visit note, dated 6/11/21, lacked documentation the nurse obtained a blood pressure. 4. Patient #3 had a start of care date of 6/23/21. Review of the clinical record revealed the following: a. The POC, dated 6/23/21 to 8/21/21, included physician orders for skilled nursing services 1 time a week to provide PICC (peripherally inserted central catheter) dressing change with lab draw each visit. b. The skilled nurse visit notes, dated 7/9/21 and 8/4/21, revealed the RN (Registered Nurse) administered Cathflo (blood anticlotting). c. During a home visit on 8/11/21 at 10:00 AM with Staff O, she flushed the patient's PICC line with 10 ml (milliliters) normal saline prior to and following the laboratory blood draw. The surveyor reviewed patient medications and noted the medication Cathflo Activase 2 mg inject 2.2 ml sterile water, gently mix and use within 8 hours. The medication filled on 7/8/21. d. Review of the clinical record lacked physician orders for normal saline flush or Cathflo. 5. Patient #4 had a start of care date of 10/15/2020. Review of the clinical record revealed the following: a. The POC, dated 6/12/21 to 8/10/21, included physician orders for skilled nursing services 1 time a week to complete assessment with attention to weights and blood sugars. b. The skilled nursing visit notes, dated 6/15/21 and 8/3/21, lacked documentation the nurse completed an assessment of the patient's weight and blood sugars. 6. Patient #1 had a start of care date of 5/15/2019 and received services from the Irving Point branch office. Clinical record review revealed an interim physician order, dated 6/17/21, included documentation to fax blood sugars in one week. The clinical record lacked documentation the patient's blood sugar results were faxed to the physician one week after 6/17/21. During an interview on 8/11/21 at 2:00 PM, the Director of Human Resources reported the agency would look for documentation the blood sugars were faxed to the physician. During an interview on 8/12/21 at 12:15 PM, the Director of Human Resources reported the Irving Point branch clinical supervisor was still looking for the list of blood sugars faxed to the physician. The above findings were reviewed with agency Administrator, Director of Human Resources, Compliance Coordinator, Office Manager for Cedar Rapids parent office, Clinical Supervisor for Irving Point and Dubuque branch offices, Clinical Supervisor for Davenport and Coralville branch offices, Clinical Supervisor for Cedar Falls branch office and Office Manager for Cedar Falls branch office. Agency staff provided no further information prior to the end of the survey.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on agency staff interview and review of governing body meeting minutes, the agency: 1) failed to develop a Quality Assessment and Performance Improvement (QAPI) program which included measurable improvements in indicators for which there is evidence that improvement may improve patient health and safety outcomes and increase quality of care. (G642); 2) failed to use quality indicator data derived from Outcome and Assessment Information Set (OASIS) and other relevant data when designing it's QAPI program. (G644); 3) failed to focus performance improvement activities on high risk, high volume or problem prone areas. (G648); 4) failed to consider incidence, prevalence and severity of a problem. (G650); 5) failed to identify a problem that directly or potentially threaten the health and safety of patients. (G652) 6) failed to identify performance improvement activities to track adverse patient events, analyze cause and implement preventative actions (G654); and 7) failed to aim actions at performance improvement and measure the success of implementation of those actions, tracking performance to ensure the improvements are sustained. (G656). 8) failed to document reasons for conducting performance improvement projects and the measurable progress achieved on these projects which reflect the scope, complexity and past performance of the home health agency's services and operations. (G658) 9) failed to ensure the governing body oversees an ongoing QAPI program that addresses priorities for improved quality of care and patient safety, all improvement actions are evaluated for effectiveness; clear expectations are established, implemented and maintained and fraud or waste are appropriately addressed. (G660) The cumulative and egregious effects of these systemic practices resulted in the failure to ensure the organizational framework of the agency promoted and supported the coordination of safe and effective delivery of care to the agency's 273 patients. The census included 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on agency staff interview and review of governing body meeting minutes, the agency failed to develop a Quality Assessment and Performance Improvement (QAPI) program which included measurable improvements in indicators for which there is evidence that improvement may improve patient health and safety outcomes and increase quality of care. The agency reported a census of 273 patients at the time of the survey. The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Findings include: Review of the agency QAPI (Quality Assessment and Performance Improvement) information and the governing body meeting minutes, dated 6/7/19, 10/15/19, 1/27/2020, 4/1/20, 8/17/20, 12/8/20, 1/6/2021, 4/20/21 and 7/6/21, lacked documentation of a QAPI program. During an interview on 8/12/21 at 9:56 AM with Staff O, QAPI Coordinator, she reported the agency has not had QAPI meetings and no QAPI has been completed due to staffing issues, the COVID 19 pandemic and the Derecho natural disaster. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on agency staff interview and review of governing body meeting minutes, the agency failed to use quality indicator data derived from Outcome and Assessment Information Set (OASIS) and other relevant data when designing it's Quality Assessment and Performance Improvement (QAPI) program. The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Findings include: Review of the agency QAPI (Quality Assessment and Performance Improvement) information and the governing body meeting minutes, dated 6/7/19, 10/15/19, 1/27/2020, 4/1/20, 8/17/20, 12/8/20, 1/6/2021, 4/20/21 and 7/6/21, lacked documentation of a QAPI program. During an interview on 8/12/21 at 9:56 AM with Staff O, QAPI Coordinator, she reported the agency has not had QAPI meetings and no QAPI has been completed due to staffing issues, the COVID 19 pandemic and the Derecho natural disaster. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on agency staff interview and review of governing body meeting minutes, the agency failed to focus performance improvement activities on high risk, high volume or problem prone areas. The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Findings include: Review of the agency QAPI (Quality Assessment and Performance Improvement) information and the governing body meeting minutes, dated 6/7/19, 10/15/19, 1/27/2020, 4/1/20, 8/17/20, 12/8/20, 1/6/2021, 4/20/21 and 7/6/21, lacked documentation of a QAPI program. During an interview on 8/12/21 at 9:56 AM with Staff O, QAPI Coordinator, she reported the agency has not had QAPI meetings and no QAPI has been completed due to staffing issues, the COVID 19 pandemic and the Derecho natural disaster. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on agency staff interview and review of governing body meeting minutes, the agency failed to focus performance improvement activities on high risk, high volume or problem prone areas. The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Findings include: Review of the agency QAPI (Quality Assessment and Performance Improvement) information and the governing body meeting minutes, dated 6/7/19, 10/15/19, 1/27/2020, 4/1/20, 8/17/20, 12/8/20, 1/6/2021, 4/20/21 and 7/6/21, lacked documentation of a QAPI program. During an interview on 8/12/21 at 9:56 AM with Staff O, QAPI Coordinator, she reported the agency has not had QAPI meetings and no QAPI has been completed due to staffing issues, the COVID 19 pandemic and the Derecho natural disaster. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This ELEMENT is not met as evidenced by: Based on agency staff interview and review of governing body meeting minutes, the agency failed to identify a problem that directly or potentially threaten the health and safety of patients. The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Findings include: Review of the agency QAPI (Quality Assessment and Performance Improvement) information and the governing body meeting minutes, dated 6/7/19, 10/15/19, 1/27/2020, 4/1/20, 8/17/20, 12/8/20, 1/6/2021, 4/20/21 and 7/6/21, lacked documentation of a QAPI program. During an interview on 8/12/21 at 9:56 AM with Staff O, QAPI Coordinator, she reported the agency has not had QAPI meetings and no QAPI has been completed due to staffing issues, the COVID 19 pandemic and the Derecho natural disaster. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on agency staff interview and review of governing body meeting minutes, the agency failed to identify performance improvement activities to track adverse patient events, analyze cause and implement preventative actions. The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Findings include: Review of the agency QAPI (Quality Assessment and Performance Improvement) information and the governing body meeting minutes, dated 6/7/19, 10/15/19, 1/27/2020, 4/1/20, 8/17/20, 12/8/20, 1/6/2021, 4/20/21 and 7/6/21, lacked documentation of a QAPI program. During an interview on 8/12/21 at 9:56 AM with Staff O, QAPI Coordinator, she reported the agency has not had QAPI meetings and no QAPI has been completed due to staffing issues, the COVID 19 pandemic and the Derecho natural disaster. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on agency staff interview and review of governing body meeting minutes, the agency failed to aim actions at performance improvement and measure the success of implementation of those actions, tracking performance to ensure the improvements are sustained. The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Findings include: Review of the agency QAPI (Quality Assessment and Performance Improvement) information and the governing body meeting minutes, dated 6/7/19, 10/15/19, 1/27/2020, 4/1/20, 8/17/20, 12/8/20, 1/6/2021, 4/20/21 and 7/6/21, lacked documentation of a QAPI program. During an interview on 8/12/21 at 9:56 AM with Staff O, QAPI Coordinator, she reported the agency has not had QAPI meetings and no QAPI has been completed due to staffing issues, the COVID 19 pandemic and the Derecho natural disaster. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on agency staff interview and review of governing body meeting minutes, the agency failed to document reasons for conducting performance improvement projects and the measurable progress achieved on these projects which reflect the scope, complexity and past performance of the home health agency's services and operations. The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Findings include: Review of the agency QAPI (Quality Assessment and Performance Improvement) information and the governing body meeting minutes, dated 6/7/19, 10/15/19, 1/27/2020, 4/1/20, 8/17/20, 12/8/20, 1/6/2021, 4/20/21 and 7/6/21, lacked documentation of a QAPI program. During an interview on 8/12/21 at 9:56 AM with Staff O, QAPI Coordinator, she reported the agency has not had QAPI meetings and no QAPI has been completed due to staffing issues, the COVID 19 pandemic and the Derecho natural disaster. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on agency staff interview and review of governing body meeting minutes, the agency failed to ensure the governing body oversees an ongoing Quality Assessment and Performance Improvement (QAPI) program that addresses priorities for improved quality of care and patents safety, all improvement actions are evaluated for effectiveness; clear expectations are established, implemented and maintained and fraud or waste are appropriately addressed. The agency reported a current census of 273 patients including 52 patients in the parent location in Cedar Rapids, 56 patients in the Cedar Falls branch, 31 patients in the Coralville branch, 54 patients in the Dubuque branch, 55 patients in the Davenport branch and 26 patients in the Irving Point branch at the time of survey. The deficient practice was identified in the Cedar Rapids parent office. Findings include: Review of the agency QAPI (Quality Assessment and Performance Improvement) information and the governing body meeting minutes, dated 6/7/19, 10/15/19, 1/27/2020, 4/1/20, 8/17/20, 12/8/20, 1/6/2021, 4/20/21 and 7/6/21, lacked documentation of a QAPI program. During an interview on 8/12/21 at 9:56 AM with Staff O, QAPI Coordinator, she reported the agency has not had QAPI meetings and no QAPI has been completed due to staffing issues, the COVID 19 pandemic and the Derecho natural disaster. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on clinical record review, agency policy review, home visit observation and staff interview, the agency failed to ensure staff provided care in accordance with agency expectations and accepted infection control standards of practice for staff observed during a home visit for 2 of 6 patients (Patients #1 and #2). The agency reported a current census of 273 patients at the time of the survey, including 52 patients who received services from the Cedar Rapids parent office, 56 patients who received services from the Cedar Falls branch office, 31 patients who received services from the Coralville branch office, 55 patients who received services from the Davenport branch office, 54 patients who received services from the Dubuque branch office, and 26 patients who received services from the Irving Point branch office. The deficient practice was identified at Dubuque and Irving Point branch offices. Failure to follow agency expectations and accepted standards of practice for infection control may put the patient at risk of receiving unsafe care or care that allows the spread of infection. Findings include: According to agency policy, titled Bag Technique, dated 3/23/2020, after hand washing, the supplies and/or equipment needed for the visit will be removed from the bag. When the visit is completed, reusable equipment will be cleaned using alcohol, soap and water, or other appropriate solution, hands will be washed, and equipment and supplies will be returned to the bag. Hands will be decontaminated prior to returning clean equipment to bag. 1. Patient #1 had a start of care date of 5/15/2019 and received services from the Irving Point branch office. Observation during a home visit on 8/10/21 at 8:45 AM with Staff D, Registered Nurse (RN), revealed the following: a. Staff D applied gloves and removed the thermometer from the nursing bag, the zipper was left unzipped on the nursing bag, Staff D checked the patient's temperature and placed the thermometer on the barrier on the counter. b. Staff D entered the nursing bag and removed a pulse oximeter, placed this on the patient's finger and checked the oxygenation of the blood and heart rate, the pulse oximeter was placed on the barrier on the counter, cleaned the pulse oximeter and thermometer with a sanitizing wipe and returned them to the nursing bag. c. Staff D removed a blood pressure cuff and placed the cuff on the patient, entered the nursing bag and removed a stethoscope and placed this around her neck, checked the patient's blood pressure, removed the blood pressure cuff and cleaned the cuff with a sanitizing wipe and returned the cuff to the nursing bag. d. Staff D listened to the patient's heart and lungs, documented in the tablet, removed the gloves, documented in the tablet, tossed the barrier and gloves in the garbage, washed her hands at the sink with soap and water, and zipped the nursing bag closed. Staff D failed to cleanse her hands prior to getting into the nursing bag and prior to returning cleaned equipment to the nursing bag. 2. Patient #2 had a start of care date of 5/7/19 and received home health services from the Dubuque branch office. On 8/11/21 at 8:29 AM, during a home visit observation, Staff J, RN for the Dubuque office, sanitized her hands prior to entering the patient's home. She then placed a clean barrier on the patient's table and placed her nursing bag on the barrier and her laptop computer. Staff J, RN, then opened the larger zipper portion of the bag and removed a thermometer. She took the patient's temperature by placing the thermometer on the patient's forehead. She then placed the thermometer on the clean field, and without sanitizing her hands, reached back in her nursing bag to unzip a smaller bag. She pulled out a blood pressure cuff with digital machine. Staff J, RN, then placed the blood pressure cuff on the patient's right upper arm and activated the machine. She then removed the used blood pressure cuff and placed this in the clean field. She then got back in her nursing bag without sanitizing her hands and pulled out a pulse oximeter. She placed the pulse oximeter on the patient's right index finger. She placed the used pulse oximeter on the clean field. She then reached in her nursing bag without sanitizing her hands and got out a stethoscope. Staff J, RN, listened to the patient's heart and lungs, palpated the patient's ankles through the patient's socks and then placed the used stethoscope on the clean field. She then picked up her laptop and typed on it. She unzipped a smaller compartment on her bag and got out a sanitizing wipe. She cleaned the pulse oximeter and placed it back on the clean field. She then cleaned the stethoscope and placed it on top of the unclean used blood pressure cuff. Staff J, RN, cleaned the thermometer next and then the blood pressure cuff and machine. She placed all vitals equipment back in the nursing bag and then wiped off the outside of the nursing bag. The nurse failed to perform hand hygiene prior to getting in her nursing bag. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

HH aide training program topics CFR(s): 484.80(b)(3) A home health aide training program must address each of the following subject areas: (i) Communication skills, including the ability to read, write, and verbally report clinical information to patients, representatives, and caregivers, as well as to other HHA staff. (ii) Observation, reporting, and documentation of patient status and the care or service furnished. (iii) Reading and recording temperature, pulse, and respiration. (iv) Basic infection prevention and control procedures. (v) Basic elements of body functioning and changes in body function that must be reported to an aide's supervisor. (vi) Maintenance of a clean, safe, and healthy environment. (vii) Recognizing emergencies and the knowledge of instituting emergency procedures and their application. (viii) The physical, emotional, and developmental needs of and ways to work with the populations served by the HHA, including the need for respect for the patient, his or her privacy, and his or her property. (ix) Appropriate and safe techniques in performing personal hygiene and grooming tasks that include -- (A) Bed bath; (B) Sponge, tub, and shower bath; (C) Hair shampooing in sink, tub, and bed; (D) Nail and skin care; (E) Oral hygiene; (F) Toileting and elimination; (x) Safe transfer techniques and ambulation; (xi) Normal range of motion and positioning; (xii) Adequate nutrition and fluid intake; (xiii) Recognizing and reporting changes in skin condition; and (xiv) Any other task that the HHA may choose to have an aide perform as permitted under state law. (xv) The HHA is responsible for training home health aides, as needed, for skills not covered in the basic checklist, as described in paragraph (b)(3)(ix) of this section. This ELEMENT is not met as evidenced by: Based on clinical record review, personnel file review and staff interview, the agency failed to ensure 4 of 4 sampled home health aides (Staff M, N, P and Q), assigned to perform tasks requiring extra skills exceeding the level of basic home health skills for 3 of 5 sampled patients (Patients #8, #9 and #10) with home health aide services, had documented evidence of competency by a registered nurse in the assigned task area prior to independently performing the task with a patient. The agency provided home health aide services to 189 patients at the time of the survey and employed 52 home health aides across 6 offices (parent office in Cedar Rapids and branch offices in Davenport, Dubuque, Cedar Falls, Irving Point and Coralville). The survey identified the deficient practice occurred at the Cedar Falls, Dubuque and Davenport branch offices. Failure to ensure home health aides successfully complete a competency evaluation in any assigned extra skills which exceed the level of basic home health aide skills placed agency patients at risk to receive inadequate or unsafe home health aide services. Findings include: The Medicare Conditions of Participation require home health agencies to determine competence of home health aides in those skills which exceed the general basic home health aide skills areas prior to assigning the home health aide to a patient who would require the task to be performed. 1. Patient #8 had a start of care date of 7/10/2020. Clinical record review revealed the following: The clinical record included documentation of an aide care plan. The aide care plan included Registered Nurse (RN) instructions to the aide to complete the extra skills task of shaving the patient. a. Patient #8's clinical record included documentation Staff Q, Home Health Aide, independently provided home health aide services to the patient. Staff Q, Home Health Aide for the Dubuque office, had a hire date of 12/21/2020. Staff Q's personnel file lacked documentation of successful completion of competency training for the skill of shaving a patient. b. Patient #8's clinical record included documentation Staff P, Home Health Aide, independently provided home health aide services to the patient. Staff P, Home Health Aide for the Dubuque office, had a hire date of 7/21/2020. Staff P's personnel file lacked documentation of successful completion of competency training for the skill of shaving a patient. 2. Patient #9 had a start of care date of 4/25/17 and discharged from services on 2/8/21. Clinical record review revealed the following: The clinical record included documentation of an aide care plan. The aide care plan included RN instructions to the aide to complete the extra skills task of applying medicated Nystatin powder. Patient #9's clinical record included documentation Staff M, Home Health Aide, independently provided home health aide services to the patient. Staff M, Home Health Aide for the Cedar Falls office, had a hire date of 6/21/02. Staff M's personnel file lacked documentation of successful completion of competency training for the skill of applying medicated powder. 3. Patient #10 had a start of care date of 4/20/17 and discharged from agency services on 5/28/21. Clinical record review revealed the following: The clinical record included documentation of an aide care plan. The aide care plan included RN instructions to the aide to complete the extra skills task of shaving the patient. a. Patient #10's clinical record included documentation Staff N, Home Health Aide, independently provided home health aide services to the patient. Staff N, Home Health Aide for the Davenport office, had a hire date of 2/4/19. Staff N's personnel file lacked documentation of successful completion of competency training for the skill of shaving a patient. On 8/12/21 at 10:26 AM, during an interview, the Office Manager for the Cedar Rapids office reported an inability to find competency evaluations for Staff M for medicated powder application and Staff N for shaving. On 8/12/21 at 10:58 AM, during an interview, the Office Manager for the Cedar Rapids office reported an inability to find documentation of competency evaluations for Staff P and Q for shaving. The Director of Human Resources received the above findings and agency staff provided no further information prior to the end of the survey.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on clinical record review, agency policy review and staff interview, the agency failed to ensure home health aides provided care to agency patients only as ordered by the physician in the Plan of Care and/or as directed in writing by the skilled professional assigning the home health aide to the patient for 3 of 5 sampled patients receiving home health aide services (Patients #1, #4 and #8). The agency reported a current census of 273 patients at the time of the survey, including 52 patients who received services from the Cedar Rapids parent office, 56 patients who received services from the Cedar Falls branch office, 31 patients who received services from the Coralville branch office, 55 patients who received services from the Davenport branch office, 54 patients who received services from the Dubuque branch office, and 26 patients who received services from the Irving Point branch office. The deficient practice was identified at Cedar Falls, Dubuque and Irving Point branch offices. Failure to ensure that home health aide services are provided only as ordered by the physician and according to the home health aide care plan increased the risk that patients' personal care needs were not adequately met. Findings include: Review of the agency's policy, titled Home Health Aide Plan of Care, dated 1/2018, identified the patient's case manager, upon initialization of aide services, will develop the home health aide plan of care. The home health aide plan of care will be individualized to the specific patient and will include type of services/procedures to be provided. On 8/9/21 at 10:06 AM, during an interview, the Clinical Supervisor for the Davenport office and Interim Clinical Supervisor for the Coralville office reported if a patient requests a home health aide complete an unassigned task, the home health aide must obtain approval from a registered nurse (RN) prior to completing the unassigned task. On 8/11/21 at 11:28 AM, during an interview, the Clinical Supervisor for the Dubuque and Irving Point branch offices reported the home health aide could go ahead an do an unassigned task, but the home health aide then needed to notify the RN to update the patient's care plan. 1. Patient #1 had a start of care date of 5/15/2019 and received services from the Irving Point branch office. Clinical record review revealed: a. The aide plan of care, dated 3/19/21, included the task to encourage/prepare fluids. b. The home health aide visit notes, dated 6/28/21, 7/8/21, 7/12/21, 7/29/21 and 8/5/21, lacked documentation the aide completed the task to encourage/prepare fluids or a reason why the task was not completed. During an interview on 8/11/21 at 2:00 PM, the Director of Human Resources reported the aides at the Irving Point branch office uses a mobile device for documentation, if the task was not marked as completed on the mobile device, it may have been marked as completed on the bubble sheet (documentation form completed by staff at the Irving Point branch office). The agency staff will look for the bubble sheets for the above dates. On 8/12/21 at 11:30 AM, the surveyor was presented with the bubble sheet for the aide visit, dated 7/12/21, the sheet lacked documentation the task to encourage/prepare fluids was completed. The bubble sheets for the other dates were not provided. The agency failed to ensure the home health aide provided care according to the aide plan of care. 2. Patient #4 had a start of care date of 10/15/2020. Clinical record review revealed: a. The Plans of Care, dated 4/13/21 to 6/11/21 and 6/12/21 to 8/10/21, included physician orders for skilled nursing visits 1 time a week and home health aide visits 2 times weekly. The Plans of Care documented Patient #4 had diagnoses of hypertensive heart disease with heart failure. b. The home health aide care plan, dated 4/11/2021, included instructions for provide the following tasks, bathing; give shower, partial sponge bath, complete sponge bath, shampoo hair, skin care; lotion, grooming; assist with dressing, brush/comb hair, blow dry hair upon request; Assist with Ambulation; ambulate independently or with a walker. c. The electronically completed home health aide visit notes, dated 6/10, 6/17, 6/15, 6/24, 7/1, 6/29, 7/8, 7/15, 7/13, 7/20, 7/29, 7/27 and 8/3/21, documental the aide provided bathing task identified "other". The aide failed to describe the task completed. 3. Patient #8 had a start of care date of 7/10/2020 and received home health services from the Dubuque branch office. Review of the clinical record revealed the following: a. The Plans of Care (POCs), dated 5/6/21 to 7/4/21 and 7/5/21 to 9/2/21, included physician orders for home health aide services 2 times per week. The POCs identified the patient had a Hoyer mechanical lift. b. The home health aide care plans, dated 3/2 and 7/26/21, included RN directions to the home health aide to pivot transfer the patient and lacked instructions to the home health aide to complete the task of passive range of motion. c. The home health aide visits, dated 6/8, 6/11, 6/15, 6/18, 6/22, 6/25, 6/29, 7/2, 7/6, 7/13, 7/16, 7/20, 7/30 and 8/3/21, all included documentation the home health aide performed passive range of motion. d. The home health aide visit, dated 7/27/21, included documentation the home health aide transferred the patient with a lift. On 8/12/21 at 10:58 AM, during an interview, the Cedar Rapids Office Manager reported an inability to find any documentation to show an RN approved the unassigned tasks of passive range of motion or transferring the patient with a lift. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.

Direct observation every 12 months CFR(s): 484.80(h)(1)(iii) A registered nurse or other appropriate skilled professional must make an annual on-site visit to the location where a patient is receiving care in order to observe and assess each aide while he or she is performing care. This ELEMENT is not met as evidenced by: Based on personnel file review and staff interview, the agency failed to ensure the documentation of annual on-site supervision to the location where the patient is receiving care in order to assess each home health aide while the aide is performing patient care for 2 of 2 sampled home health aides (Staff M and N) requiring annual on-site supervision. The agency provided home health aide services to 189 patients at the time of the survey and employed 52 home health aides across 6 offices (parent office in Cedar Rapids and branch offices in Davenport, Dubuque, Cedar Falls, Irving Point and Coralville). The survey identified the deficient practice occurred at the Cedar Falls and Davenport branch offices. Failure to ensure the agency maintained documentation of annual on-site supervision to the location where the patient is receiving care in order to assess each home health aide while the aide is performing patient care placed agency patients at risk to receive inadequate or unsafe home health aide services. Findings include: 1. Staff M, Home Health Aide for the Cedar Falls office, had a hire date of 6/21/02. The personnel file for Staff M included documentation of annual on-site supervision by a registered nurse (RN), dated 1/26/18, and a subsequent on-site supervision, dated 6/12/19. The RN completed the on-site supervision for Staff M 5 months past the annual due date. 2. Staff N, Home Health Aide for the Davenport office, had a hire date of 2/4/19. The personnel file for Staff N lacked documentation of annual on-site supervision by a RN. Staff N was due for an annual on-site supervision prior to the implementation of the pandemic 1135 blanket waiver of this regulation in March 2020. On 8/12/21 at 10:26 AM, during an interview, the Office Manager for the Cedar Rapids office reported an inability to find documentation of annual on-site supervision of Staff N, Home Health Aide. The Human Resources Director received the above findings and agency staff provided no further information prior to the end of the survey.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on clinical record review, agency policy review and staff interview, the agency failed to ensure the patient's clinical record included accurate documentation of interventions and maintained pertinent current information in the patient record for 3 of 10 sampled patients (Patients #2, #5 and #6). The agency reported a current census of 273 patients, including 52 patients served through the parent office in Cedar Rapids, 56 patients served through the Cedar Falls branch office, 31 patients served through the Coralville branch office, 54 patients served through the Dubuque office, 55 patients served through the Davenport branch office and 26 patients served through the Irving Point branch office. The survey identified the deficient practice occurred at the Dubuque, Davenport and Coralville branch offices. Failure to ensure the patient's clinical record included pertinent current and accurate documentation of interventions placed agency patient's at risk for not receiving the correct interventions and for other disciplines providing services to have unclear or inaccurate information regarding the patient's condition. Findings include: Review of the agency's policy, titled Clinical/Service Data Collection, dated 1/2018, identified staff are required to make all entries into the clinical record on the day staff provide service and staff must submit all documentation within 72 hours of the date of the visit. On 8/9/21 at 10:06 AM, during an interview, the Clinical Supervisor for the Davenport office/interim Clinical Supervisor for the Coralville office reported the expectation agency staff will complete visit documentation on the same day of the visit. On 8/11/21 at 11:28 AM, during an interview, the Clinical Supervisor for the Dubuque/Irving Point branch offices reported the expectation staff document visits at the patient's home. 1. Patient #2 had a start of care date of 5/7/19 and received home health services from the Dubuque branch office. Review of the clinical record revealed the following: a. The Plans of Care (POCs), dated 4/26/21 to 6/24/21 and 6/25/21 to 8/23/21, included physician orders for skilled nursing services. The POCs did not include orders for any other home health service. b. A skilled nursing visit note, dated 6/16/21, included documentation the nurse supervised a home health aide. The nurse documented the home health aide always honored the patient's rights, demonstrated competency, maintained open communication, notified the supervisor of changes, practiced universal precautions and used safe body mechanics. c. The clinical record lacked documentation of a physician order for home health aide services and lacked documentation the patient had received the service. The nurse documented the supervision of a home health aide and no home health aide services were provided/ 2. Patient #5 had a start of care date of 7/27/21 and received home health services from the Davenport branch office. Review of the clinical record on 8/9/21 revealed the following: a. The POC, dated 7/27/21 to 9/24/21, included orders for skilled nursing services 3 times per week. b. The week of 7/27/21 included documentation of an extra skilled nursing visit, dated 7/31/21. Staff H, Registered Nurse (RN) for the Davenport office, documented she completed wound care to skin tear on the left arm. She documented she cleansed the wound with Normal Saline and covered the wound with dry gauze and Kerlix (a type of wrap gauze). c. The week of 8/1/21 included documentation of 3 skilled nursing visits, dated 8/2, 8/4 and 8/6/21. The visit, dated 8/2, included documentation the Clinical Supervisor for the Davenport office/Interim Clinical Supervisor for the Coralville office described the wound bed as "red/brown". The visit, dated 8/4, included documentation Staff H, RN for the Davenport office, described the wound bed as pink with granulation tissue (healing). Both nurses documented they cleansed the left arm wound with Normal Saline and covered the wound with dry gauze and Kerlix. The skilled nursing visit, dated 8/6/21, included documentation the Clinical Supervisor for the Davenport office/Interim Clinical Supervisor for the Coralville office cleansed the left arm wound with Normal Saline and left the wound open to air. d. The clinical record lacked documentation of a physician's order for wound care treatment to the left arm. On 8/9/21 at 12:39 PM, during an interview, the Clinical Supervisor for the Davenport office/interim Clinical Supervisor for the Coralville office reported she would have to ask the nurse, Staff H, Registered Nurse (RN) for the Davenport office, about the extra nursing visit on 7/31/21. On 8/9/21 at 1:13 PM, during an interview, Staff H, RN for the Davenport office, explained she got an order for the extra skilled nursing visit on 7/31/21 to provide wound care. She forgot to put the order in the system, but explained the physician's order was in the patient's record now. Review of the physician's order, dated 8/9/21 as a late entry, included documentation of an order to perform wound care on a new skin tear on the patient's right (not left) forearm by applying a non-adherent pad and wrap with gauze. The nurse failed to ensure the wound care order was part of the patient record in a timely manner to ensure all nurses providing care to the patient could accurately provide that care. 3. Patient #6 had a start of care date of 7/24/17 and received home health services from the Coralville branch office. Review of the clinical record on 8/10/21 revealed the following: a. The POC, dated 7/3/21 to 8/31/21, included orders for skilled nursing services 1 time per week. b. The clinical record lacked documentation of a skilled nursing visit the week of 8/1/21. On 8/10/21 at 10:50 AM, during an interview, the surveyor notified the Clinical Supervisor for the Davenport office/Interim Clinical Supervisor for the Coralville office about the inability to find a skilled nursing visit for the week of 8/1/21. On 8/10/21 at 11:20 AM, during an interview, the Clinical Supervisor for the Davenport office/Interim Clinical Supervisor for the Coralville office reported a licensed registered nurse (LPN) completed a skilled nursing visit on 8/6/21, but had not entered the documentation in the system yet. On 8/11/21 at 1:20 PM, during an interview, the Clinical Supervisor for the Davenport office/Interim Clinical Supervisor for the Coralville office reported the nurse had not documented the visit in the patient's electronic record as of the end of the day on 8/10/21. c. On 8/12/21 at 11:30 AM, review of the patient's electronic medical record revealed a lack of documentation of a skilled nursing visit for the week of 8/1/21. The Director of Human Resources, Office Manager for the Cedar Rapids office, Clinical Supervisors for the Dubuque, Irving Point, Coralville and Davenport offices received the above findings and agency staff provided no further information prior to the end of the survey.