Every finding on record at Iowa Home Care, LLC

A Recertification Survey was conducted by the Department of Inspections, Appeals and Licensing from 8/11/25 through 8/13/25, and the home health agency was found to be operating out of compliance with the following standard level regulatory requirements of the Establishment of Emergency Preparedness.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on agency staff interview and review of emergency preparedness training documentation, the agency failed to ensure training in emergency preparedness to all current staff annually. Lack of emergency preparedness training for staff puts patients at risk should an emergency situation arise and staff would be needed to assist patients to ensure patient safety. According to the agency's policy titled Emergency During the review of the agency's emergency preparedness plan, the training includes initial training in emergency preparedness policies and procedures and their assigned emergecny respone roles to all new and existing staff, individuals providing service under arragement, and volunteers if applicable. The training is provided at least every 2 years and demonstrates staff knowlege of emergency procedures. During an interview on 8/13/25 at 9:35 AM, the Administrator stated the contract agency failed to provide documentation training for Staff F, Physical Therapy Assistant (PTA) and Staff G, Occupational Therapist (OT) had been completed for the emergency preparedness plan. a. Staff F, PTA, had a hire date of 4/1/23. Review of the emergency prepardness documentation lacked training for the emergency preparedness plan. b. Staff G, OT, had a hire date of 8/8/24. Review of the emergency prepardness documentation lacked training for the emergency preparedness plan. The above findings were reviewed with the agency President, Administrator, Clinical Manager, QAPI Coordinator and Corporate Clinical Lead RN.

A Recertification Survey was conducted by the Department of Inspections, Appeals and Licensing from 8/11/25 through 8/13/25. The recertification survey found the agency operating out of compliance with the following standard level regulatory requirements: The agency reported a census of 91 patients at the time of the survey.

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: Based on record review, staff interview and agency policy review, the agency failed to obtain the patient's or the patient's legal representative's signature confirming he or she had received a copy of the notice of rights and responsibilities prior to the start of services for 1 of 7 sampled patients (Patient #7). Failure to obtain the patient''s or the patient's legal representative's signature confirming they received a copy of the notice of the rights and responsibilities, placed the patient at risk to not have their rights protected and failed to promote the exercise of these rights. Findings include: According to the agency policy titled Patient Bill of Rights, dated November 2023, each patient will be an active, informed participant in his/her plan of care. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. If a state court has not adjudged a patient to lack legal capacity to make health care decisions as defined by state law, the patient may designate someone to act as his/her representative to exercise the patient's rights. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care of their rights. The patient consumer service agreement will contain the acknowledgment of the patient's receipt and review of the patient's rights, responsibilities and privacy statement forms. The patient consumer service agreement will be signed by the patient or legal representative. During an interview on 8/12/25 at 4:10 PM Staff E, Corporate Clinical Lead, stated the agency had confusion with the assessment to start the contract with the pharmacy that provided the medication for the patient. She further stated the assessment drives the consent forms to start the services. The agency did the outcome and assessment information set (oasis) collection but had a hiccup with the consent forms. Patient #7 had a start of care date of 3/28/25 and was discharged from the agency on 5/22/25. Clinical record review revealed the following: a. The plan of care (POC), dated 3/28/25 to 5/22/25, identified the patient had the diagnosis of Alpha-1+antitrypsin deficiency. The POC included orders for skilled nurse services 1 time a week to provide intravenous (IV) access and Prolastin-C (alpha-proteinase inhibitor) IV medication administration. b. The skilled nurse visit at start of care, dated 3/28/25, included a hands on assessment and venipuncture for IV access in the right antecubital area with a 25 gauge needle. The medication Prolastin-C administered and the IV flushed with 10 ml normal saline. c. The electronic patient/consumer service agreement, dated 4/3/25, included Staff B, Clinical Manager and the patient's signature the patient received a copy and explanation of their rights and responsibilities (6 days after the patient's start of care). The agency failed to include evidence of the patient's or the patient's legal representative's signature confirming they received a copy and explanation of their rights and responsibilities prior to the start of care. The above findings were reviewed with the agency President, Administrator, Clinical Manager, QAPI Coordinator and Corporate Clinical Lead RN.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on record review, staff interview and agency policy review, the agency failed to obtain the patient's or the patient's legal representative's signature confirming he or she had consented to services with the knowlege of services provided and the charges the patient may have to pay before care is initiated for 1 of 7 sampled patients (Patient #7). Failure to obtain the patient''s or the patient's legal representative's signature confirming they received a copy of the notice of the rights and responsibilities, placed the patient at risk to not have their rights protected and failed to promote the exercise of these rights. Findings include: According to the agency policy titled Informed Consent/Refusal of Treatment, dated October, 2024, upon admission and follow-up visits, the patient and family/caregiver will be given information (verbally and/or in writing) that describes: the services and/or disciplines anticipated to be involved in the care/service of the patient. During an interview on 8/12/25 at 4:10 PM Staff E, Corporate Clinical Lead, stated the agency had confusion with the assessment to start the contract with the pharmacy that provided the medication for the patient. She further stated the assessment drives the consent forms to start the services. The agency did the outcome and assessment information set (oasis) collection but had a hiccup with the consent forms. Patient #7 had a start of care date of 3/28/25 and was discharged from the agency on 5/22/25. Clinical record review revealed the following: a. The plan of care (POC), dated 3/28/25 to 5/22/25, identified the patient had the diagnosis of Alpha-1+antitrypsin deficiency. The POC included orders for skilled nurse services 1 time a week to provide intravenous (IV) access and Prolastin-C (alpha-proteinase inhibitor) IV medication administration. b. The skilled nurse visit at start of care, dated 3/28/25, included a hands on assessment and venipuncture for IV access in the right antecubital area with a 25 gauge needle. The medication Prolastin-C administered and the IV flushed with 10 ml normal saline. c. The electronic patient/consumer service agreement, dated 4/3/25, included Staff B, Clinical Manager and the patient's signature, the patient received a copy and explanation of the services to be provided and liability for payment (6 days after the patient's start of care). The agency failed to include evidence of the patient's or the patient's legal representative's signature confirming they received a copy and explanation of the patient/consumer service agreement prior to the start of care. The above findings were reviewed with the agency President, Administrator, Clinical Manager, QAPI Coordinator and Corporate Clinical Lead RN.

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 1 of 7 sampled patients (Patient #4). 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: According to agency policy, titled Physician Provider Orders, dated October 2024, the individualized plan of care (POC) includes: all patient care orders including verbal orders and medications including dose/frequency/route/purpose. Patient #4 had a start of care date of 4/21/21. Review of the clinical record revealed the following: a. The POCs, dated 5/30/25 to 7/28/25 and 7/19/25 to 9/26/25, identified the patient had diagnosis that included myocardial infarction and included orders for medications with skilled nurse medication set up every other week, vital sign parameters for systolic blood pressure 80 to 160 and report abnormal values. The POC also included orders for the skilled nurse to assist the patient with change of glucometer devise and to observe and assess glucometer readings for patterns of hyper/hypo glycemia and report abnormal findings/concerns to physician. The POC also included order for an extra skilled nurse visit for recertification visits. b. The skilled nurse visit note, dated 6/11/25, Staff C, Licensed practical nurse (LPN) lacked documentation of the nurse assessed glucometer readings for patterns of hyper/hypo glycemia. c. The skilled nurse visit note, dated 7/8/25, Staff C, LPN, documented the visit and patient's medication set up completed. The clinical record lacked documentation for an every other week visit scheduled for 7/22/25. d. The comprehensive assessment at recertification, dated 7/25/25, Staff Registered Nurse (RN) included documentation the dexcom (continuous glucose monitor) had not been in place since 7/22/25 and he/she ran out of medications on 7/22/25. The RN also documented the patient had taken his/her warfarin (blood thinner) and insulin. The comprehensive assessment lacked documentation of physician notification of missed medications and glucose monitoring. e. The skilled nurse visit note, dated 7/25/25, included documentation the patient's systolic blood pressure reading at 162 (greater than ordered parameters of 160). The electronic clinical record lacked documentation of physician notification of the elevated blood pressure. The clinical record lacked completion of the physician orders per the patient's POC. The above findings were reviewed with the agency President, Administrator, Clinical Manager, QAPI Coordinator and Corporate Clinical Lead RN.

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on home observation visit, clinical record review and agency policy review, the agency failed to obtain current medication orders for 1 of 3 sampled patients with a home observation visit (Patient #1). Failure to maintain complete and accurate Plans of Care with current orders placed the patient at risk to not receive services, medication and/or treatments according to assessed needs and physician orders. Findings include: According to the agency policy titled Verification of Physician Orders, revised 10/2024, verbal orders will be spoke to, taken and documented only by professional, licensed home health personnel. All verbal orders received by home health professionals will be denoted with date/time of order receipt and will be documented in the patient's clinical record. According to the agency policy titled Medication Profile, revised 10/2024, 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 new medication. During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure the patient as well as other clinicians understand the medication regiment. Any conclusions and findings of patient medication use and monitoring should be communicated to the physician. Patient #1 had a start of care date of 4/10/23. Clinical record review revealed: a. The Plan of Care (POC), dated 7/28/25 to 9/25/25, identified the patient had a diagnosis of Chronic Obstructive Pulmonary Disease with exacerbation. The POC included orders for skilled nursing services and medications. b. During a home observation visit on 8/11/25 at 4:30 PM with Staff C, Licensed Practical Nurse (LPN), surveyor observed a bottle of oxycodone-acetaminophen 5 milligrams (mg)-325 mg with instructions to take 1 tablet by mouth every 6 hours as needed for pain. Bottle was last filled on 8/10/25. The agency medication profile identified oxycodone-acetaminophen 10mg-325mg oral tablets every 8 hours as needed for pain. During this same visit, patient reported he/she had taken the same dose of the medication for a long time; however, it was recently changed to reflect it can be taken every 6 hours as needed. Surveyor also identified a bottle of hydrocodone-acetaminophen 5mg-325mg oral tablets that expired on 10/8/24. During an interview, the patient reported he/she has not taken that medication for greater than 6 months. c. Skilled nurse visit note, dated 8/11/25, signed completed by Staff C, LPN, failed to identify care coordination with the case manager regarding the need for an updated verbal order for oxycodone-acetaminophen and failed to remove the hydrocodone-acetaminophen from the medication profile as the prescription expired and the patient reported no longer using the medication. d. Review of the clinical record lacked documentation of an updated verbal order for the medication oxycodone-acetaminophen. The agency failed to include verbal orders for all medications required by the patient and failed to maintain a current medication profile. The above findings were reviewed with the agency President, Administrator, Clinical Manager, QAPI Coordinator and Corporate Clinical Lead RN.

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 agency staff interview, clinical record review, personnel file review and agency policy review, the agency failed to ensure 3 of 4 sampled home health aides (Staff I, Staff J and Staff K), assigned to perform tasks requiring extra skills exceeding the level of basic home health skills for 2 of 3 sampled patients (Patients #1 and #2) 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 39 patients at the time of the survey and employed 7 home health aides. 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 the 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. According to the agency policy titled Competency Program, revised 11/2024, the organization will clearly identify and define the skills, which are essential to observe for the determination of competence for each job category. After completion of orientation, competency will be monitored annually thereafter as part of the annual performance field evaluation process. Competency will also be monitored when personnel are performing a new procedure or using a piece of equipment for the first time. During an interview on 8/12/25 at 3:45 PM, the Administrator reported extra skills competencies are identified in each home health aide's personnel file. 1.Patient #1 had a start of care date of 4/10/23. Clinical record review revealed: a. The aide care plan included Registered Nurse (RN) instructions to the aide to apply orthotic brace to left foot after shower every visit. b. Review of the clinical record showed Staff J and Staff K, Home Health Aides, provided aide services independently for Patient #1. c. Staff J, Home Health Aide, had a hire date of 12/4/23. Staff J's personnel file lacked documentation a RN had observed Staff J competently perform the task apply orthotic brace. d. Staff K, Home Health Aide, had a hire date of 6/30/22. Staff K's personnel file lacked documentation a RN had observed Staff K competently perform the task apply orthotic brace. 2.Patient #2 had a start of care date of 8/14/20. Clinical record review revealed: a. The aide care plan included RN instructions to the aide to apply topical ointment and to apply a simple dressing every visit. b. Review of the clinical record showed Staff I, Home Health Aide, provided aide services independently for Patient #2. c. Staff I, Home Health Aide, had a hire date of 8/5/25. Staff I's personnel file lacked documentation a RN had observed Staff I competently perform the tasks apply topical ointment and apply a simple dressing. The agency failed to ensure home health aides successfully completed a competency evaluation in assigned extra skills prior to performing the extra skills. The above findings were reviewed with the agency President, Administrator, Clinical Manager, QAPI Coordinator and Corporate Clinical Lead RN.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This ELEMENT is not met as evidenced by: Based on staff interview, clinical record review and policy review, the agency failed to ensure a registered nurse or other appropriate health care professional completed home health aide supervision at least every 14 days for 1 of 2 sampled patients (Patient #1) with a home observation visit who received hands on personal care services in conjunction with a skilled service provision. The agency reported 39 patients who received home health aide services with every 14 day supervision. Failure to supervise home health aide services at least every 14 days increased the risk that patients received unsatisfactory or inappropriate care from home health aides. Findings include: According to the agency's policy titled Responsibilities/Supervision of Clinical Services, revised 11/2024, home health aide supervisory visits will be conducted on-site at least every 14 days by skilled personnel. Supervisory visits can be made in conjunction with the home health aide or in his/her absence. During an interview on 8/12/25 at 9:00 AM, the Clinical Manager stated aide supervision is done every 14 days and it is documented in a form pulled into the nursing visit. Patient #1 had a start of care date of 4/10/23. Clinical record review revealed: a. The Plans of Care (POC), dated 5/29/25 to 7/27/25 and 7/28/25 to 9/25/25, identified the patient had a diagnosis of Chronic Obstructive Pulmonary Disease with exacerbation and included physician orders for skilled nursing and home health aide services. b. The skilled nurse recertification visit note, dated 7/25/25, completed by Staff H, Registered Nurse (RN), included documentation of home health aide supervision. c. As of 8/11/25, home health aide supervision had not been completed again (3 days late). The agency failed to provide home health aide supervision every 14 days. The above findings were reviewed with the agency President, Administrator, Clinical Manager, QAPI Coordinator and Corporate Clinical Lead RN.

The Department of Inspections and Appeals conducted a complaint survey, dated 3/27/23 through 3/29/23 related to complaint #96735. The complaint survey found the hospice operating out of compliance with the Condition of Participation 42 CFR 484.110.54 Initial and Comprehensive Assessment of Patient with standard level deficiency (see G1030) and operating in substantial compliance with 42 CFR 484.60: Care Planning, Coordination of Services and Quality of Care. The hospice reported a census of 162 current patients.

Retrieval of records CFR(s): 484.110(e) Standard: Retrieval of clinical records. A patient's clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first). This STANDARD is not met as evidenced by: Based on record review, policy review and staff and patient interview the agency failed to ensure the patients clinical record is available to the patient free of charge within 10 business days (per the PHE waiver) for 1 of 6 patients reviewed. (Patient #5) The cumulative systemic practice resulted in the failure of the agency to ensure agency staff had a process in place to provide and document care and services provided. According to the agency policy titled Patient Requests For Access To Personal Health Information, dated June 2018, all requests by a Patient to inspect and obtain a copy of protected health information will be made in writing to the position or office designated by the agency. The titles of the persons or offices responsible for receiving and processing requests for access by Patients will be documented. The request will be reviewed by designated organization personnel to determine whether it will be approved or denied, in accordance with all applicable laws. The agency will act on the Patient's written request for access no later than 4 business days after receipt of the request. Patient #4 had a start of care date of 4/28/22 and discharge date of 6/25/22. a. The release of information, dated 3/2/23, included a release of information for the provider. b. The care coordination notes, dated 3/27/23, late entry for 2/3/23, identified the patient called the office and stated they had been talking with the previous Administrator about how to get a copy of the medical record. The patient stated the previous Administrator had stated he/she would mail a release of information and the patient identified the release had not been received. c. The care coordination notes, dated 3/27/23, late entry for 3/6/23, identified the patient called the office and stated the agency never sent information to the Doctor. Staff informed the patient that the physician never sent a request for information. The patient stated they didn't need too and she wanted the whole medical record. Staff apologized for the misunderstanding in the communication and had been under the impression that the patient was going to request what was needed to be sent. The patient stated they wanted the whole medical record. d. During an interview on 3/28/23 at 3:28 pm Staff A, Interim Administrator stated she did not know when the patient originally requested the medical records. The patient called at the beginning this month for records to go to the Doctor. We filled out a release of information as they had identified a new Doctor that we had no release of information on. We could not give her records for the Doctor's office because the office did not identify what records they needed. Staff documented the telephone calls with the patient on 3/27/23 and identified late entries. The patient was discharged and staff did not know that they could document in the electronic medical record after discharge. We found out that we could and we knew they requested the information to be sent to her doctor but never got the request from the doctors office. During an interview on 3/28/23 at 3:40 PM Staff C, Administrative Assistant, stated the 1st time the patient called her was in early February, 2023. The patient stated they had worked with the previous Administrator and wanted a copy of their medical records. The Administrator at that time stated they needed a release of information from the Doctor to get a copy of the records. I was confused why they needed a release if they wanted their own records. I contacted the Interim Administrator and we worked on it. We were told they needed a release of information. The Interim Administrator got a signed release of information and we were in the process of getting a copy of the chart completed, but the Office Manager went on vacation and it did not get completed. The patient called back again last week to check on the medical records. I told him/her we had been working on getting a copy of the record. During an interview on 3/28/23 at 3:47 PM Staff D, Office Manager, she stated the previous Administrator did not identify that the patient had called her or had talked to her about the medical record. The patient stated they wanted a release of information. She told me it was because she wanted records for her Doctor. Staff D stated the patient never needs a request from the Doctor for a copy of the medical record. The patient stated the previous Administrator told him/her they needed a release of information from Doctor to get a copy of the chart. We had been working on getting the copy of the medical record done. I started working on copying the record before I went on vacation and left for vacation on 3/15/22. I was unaware there was a time limit to give patients a copy of the medical record. The copy of the medical record is done and on its way to be delivered to the patient by the Interim Administrator today (3/28/23). The above findings were reviewed with the Chief of Organizational Performance, Interim Administrator and Staff E, RN. No additional information provided prior to the end of the survey.

A recertification survey was conducted by the Department of Inspections and Appeals from 8/22/22 through 8/25/22. The survey found the agency operating in substantial compliance with the requirements of the Establishment of Emergency Preparedness.

A recertification survey was conducted by the Department of Inspections and Appeals from 8/22/22 through 8/25/22. The recertification survey found the agency operating out of compliance with the following standard level regulatory requirements: The agency reported a current census of 175 patients at the time of the survey.

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 of Care for 1 of 7 sampled patients (Patient #3). Failure to notify the physician of the need to vary from the physician ordered Plan of Care placed the patients at risk to not receive services, medications, and/or treatments according to assessed needs and physician orders. Findings include: Agency policy titled, Care Planning Process, dated 1/2022, identified clinicians will inform the patient’s physician of any changes that suggest a need to alter the plan of care. Changes must be written, dated, and signed by the professional making the changes. Patient #3 had a start of care date of 7/26/22. Clinical record review revealed: a. Plan of Care, dated 7/26/22 to 9/23/22, included physician orders for skilled nursing services 2 times a week for 60 days. b.. Skilled nursing visits, dated 7/30/22, 8/5/22 and 8/12/22. c. One skilled nursing visit completed for the weeks of 7/31/22 and 8/7/22. During an interview on 8/24/22 at 2:09 PM, West DesMoines (WDM) Clinical Manager reported she had reviewed the clinical record and confirmed no documentation regarding the missed visits for the weeks of 7/31/22 and 8/7/22. The clinical record lacked documentation of the reason why one skilled nursing visit was made for the weeks of 7/31/22 and 8/7/22 or that the physician was notified of the missed visits. The above stated findings were reviewed with Clinical Manager, WDM Clinical Manager and Chief of Organizational Performance. The agency provided no additional information prior to the end of the survey.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on clinical record review and agency staff interview, the agency failed to update the Plan of Care with all new physician orders for 1of 2 sampled patients with interim resumption of care orders. (Patient #5). Failure to update the Plan of Care increased the potential for medication errors in administration or inaccurate provision of care. Findings include: Agency policy, titled Care Planning Process, dated 1/2022, identified clinicians will inform the patient’s physician of any changes that suggest a need to alter the plan of care. Changes must be written, dated, and signed by the professional making the changes. Agency policy, titled Reassessment/Recertification, dated 5/2022, identified revisions to the plan of care shall be communicated as follows: all communication shall be documented in the clinical record and the plan of care shall be updated and a verbal order sent to the physician. Patient #5 had a start of care date of 10/14/16. Clinical record review revealed: a. The Plan of Care, dated 7/15/22 to 9/12/22, included orders for skilled nursing services 2 times a week for 7 days and 1 time a week for 51 days. b. Resumption of Care interim physician orders, dated 8/5/22, included orders for skilled nursing but lacked a frequency of visits, physical therapy to evaluate and treat, and occupational therapy to evaluate and treat. c. Iowa City Veterans Affairs Referral faxed paperwork, dated 8/5/22, included approval for skilled nursing visits 3 times a day from 8/5/22 to 8/8/22, then daily skilled nursing visits from 8/9/22 to 8/15/22. The clinical record lacked documentation of the approved skilled nursing frequency on the resumption of care interim physician orders. The clinical record lacked documentation of a Plan of Care update for the certification period, dated 7/15/22 to 9/12/22, which included the resumption of care orders dated 8/5/22. During an interview on 8/25/22 at 10:27 AM, the Chief of Operational Performance reported she reviewed the clinical record and located the Iowa City Veterans Affairs Referral fax, dated 8/5/22, and confirmed the skilled nurse frequency was not entered on the resumption of care orders and the plan of care was not updated with the skilled nurse visit frequency due to a transcription issue that allowed the resumption of care order to be sent out without the skilled nurse frequency. The above stated findings were reviewed with Clinical Manager, West DesMoines Clinical Manager and Chief of Organizational Performance. The agency provided no additional information prior to the end of the survey.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on clinical record review, the agency failed to ensure skilled professionals provided care as ordered by the physician in the Plan of Care for 1 of 7 sampled patients (Patient #1). Failure to provide care in accordance with the physician ordered Plan of Care placed patients at risk to receive unsafe, non-individualized and inconsistent care designed to meet each patients' health care needs. Findings include: Agency policy titled, Care Planning Process, dated 1/2022, identified the plan of care will include specific services and treatments to be provided. The plan of care will be based upon the physician’s orders and will encompass the equipment, supplies and services required to meet the patient’s needs. Clinician will inform the patient’s physician of any changes that suggest a need to alter the plan of care. Changes must be written, dated and signed by the professional making the changes. Patient #1 had a start of care date of 5/26/22. Clinical record review revealed skilled nursing visit note, dated 8/16/22, included documentation the patient had clipped the left great toe nail to short and caused a small bleed. The nurse cleansed the area with wound wash, applied triple antibiotic ointment and wrapped the toe with telfa gauze and coban (stretchy dressing that adheres to itself). The clinical record lacked documentation the nurse contacted the physician for an order to provide wound care to the left great toe. The above stated findings were reviewed with Clinical Manager, West DesMoines Clinical Manager and Chief of Organizational Performance. The agency provided no additional information prior to the end of the survey.

The #100319-C (C-47715) complaint investigation, conducted by the Department of Inspections and Appeals from 11/1/2021 through 11/3/2021, resulted in substantiation of the complaint allegations and found the agency operating out of compliance with the Condition of Participation 42 CFR 484.60 Care Planning, Coordination and Quality of Care ( G570, G580 and G590). CMS authorized an extended complaint survey. The State Agency completed a Covid-19 Infection Control Survey in conjunction with the extended complaint survey, initiated on 11/29/2021 and concluded on 12/7/2021. The extended complaint survey found the agency operating in substantial compliance with the requirements of the Establishment of Emergency Preparedness.

The #100319-C (C-47715) complaint investigation, conducted by the Department of Inspections and Appeals from 11/1/2021 through 11/3/2021, resulted in substantiation of the complaint allegations and found the agency operating out of compliance with the Condition of Participation 42 CFR 484.60 Care Planning, Coordination and Quality of Care ( G570, G580 and G590). The agency reported a current census of 206 patients at the time of the initial survey. CMS authorized an extended complaint survey. The State Agency conducted a Covid-19 Infection Control Survey in conjunction with the extended complaint survey, initiated on 11/29/2021 and concluded on 12/7/2021. The extended complaint survey found the agency operating out of compliance with 2 additional Conditions of Participation: 42 CFR 484.55 Comprehensive Assessment of Patients (G510, G514, G536, G546, G550) and 42 CFR 484.110 Clinical Records (G1008, G1022, G1028). The survey also found the agency operating out of compliance with multiple standard level deficient practices (G798, G800, G814). The agency reported a current census of 194 patients at the time of the extended complaint survey. The survey also found the agency breached the prohibition previously set on 8/4/2021 for training and competency testing of home health aides. Due to the non-compliance with the prohibition, the agency will be prohibited from basic training and competency testing for the core services for any newly hired home health aides, beginning on 12/7/2021 and ending on 12/7/2023. (G788) The survey found the agency operating in substantial compliance with CMS requirements for Covid-19 Infection Control.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on agency policy review, clinical record review and agency staff interview, the agency was not operating in compliance with the Condition of Participation for the following reasons: 1) failed to ensure initial visits occurred within 48 hours of referral or within 48 hours of knowledge of the patient's discharge from an inpatient facility when the physician did not give a specific start of care date (G514); 2) failed to complete a drug regimen review with all comprehensive assessments and/or failed to identify actual or potential medication issues during the drug regimen review (G536);. 3) failed to ensure comprehensive assessments were updated within the last five days of every 60 day period beginning with start of care (G546); and 4) failed to ensure comprehensive assessments were updated within 48 hours of knowledge of the patient's need for discharge (G550). The cumulative systemic practices resulted in the failure to ensure the organizational framework of the agency to coordinate safe, effective individualized care to the agency's 194 patients.

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 and agency staff interview, the agency failed to provide an initial assessment visit within 48 hours of receipt of referral, within 48 hours of the of the agency's knowledge of the patient's return home from an inpatient facility or on the physician ordered start of care date for 2 of 7 sampled patients (Patients #9 and #14). The agency reported a current census of 194 patients at the time of the extended survey. Failure to provide an initial assessment visit within 48 hours put agency patients at risk for not having immediate care needs met. Findings include: 2. Patient #9 had a start of care date of 8/11/2020. Clinical record review revealed: a. The referral form, dated 7/28/2020, documented the physician's office referred the patient for medication set up. b. The initial comprehensive assessment dated 8/11/2020, identified a start of care date of 8/11/2020. c. A verbal order received from the physician, dated 8/10/2020, was added to the 7/28/2020 referral form, documented the agency would perform the start of care on 8/11/2020. d. The clinical record lacked documentation of the reason the assessment not completed in the 48 hour time frame or Physician notification of the delay of the start of care until 8/10/2020. The agency lacked documentation of contact with the physician to request a change in the start of care date prior to 48 hours from the receipt of referral. The above findings were reviewed with the agency Administrator and the Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey. According to the Policy and Procedure titled Initial and Comprehensive Assessment, dated 5/2018, the initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the agency's knowledge of the patient's return home from an inpatient facility or on the start of care date ordered by the physician. During agency staff interview on 11/29/2021 at 9:12 AM, the Administrator reported initial assessment visits are tracked via the agency's electronic clinical record system. The Administrator reported she and the Clinical Managers oversee to determine compliance. During agency staff interview on 12/1/2021 at 10:02 AM, Staff B, Clinical Manager, reported she reviews notes every morning. If unable to review, is in contact verbally with each registered nurse (RN). She and Staff A, the other Clinical Manager, make sure the agency maintains compliance with the requirement for initial visits completed within 48 hours. 1. Patient #14 had a start of care date of 10/17/2021. Clinical record review revealed the following: a. Agency referral documentation identified the date of referral was 10/14/2021. b. The initial comprehensive assessment completed at the time of start of care, dated 10/17/2021, documented the referral date for the patient was 10/14/2021. c. Documentation from the physician, dated 10/14/2021 and sent to the agency by facsimile on 10/14/2021, documented the patient was discharged from the hospital on 10/9/2021. The document approved home health services for the patient. The agency did not admit Patient #14 until 10/17/2021, 72 hours or 3 days after receiving the referral. The agency failed to complete the initial assessment within 48 hours of receipt of referral.

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 agency policy review, clinical record review and agency staff interview, the agency failed to complete a drug regimen review within the required time frames as part of the initial comprehensive assessment at start of care and/or as part of the update to the comprehensive assessment at the time of recertification, resumption of care and discharge for 7 of 10 sampled patients (Patients #4, #9, #10, #11, #14, #15 and #17). The agency reported a current patient census of 194 patients at the time of the extended survey. 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. Findings Include: 6. Patient #4 had a start of care date of 2/18/21 and was discharged from agency services on 8/13/21. The patient was readmitted on 8/17/21. Clinical record review revealed the following: a. The update to the comprehensive assessment at the time of recertification, dated 6/17/21, lacked documentation of completion of a drug regimen review. b. The update to the comprehensive assessment at the time of discharge, dated 8/13/21, included a drug regimen review, however lacked documentation of duplicate drug therapy for prescribed medications including Tylenol and Trazodone (both ordered to treat pain). c. The update to the comprehensive assessment at the time of recertification, dated 10/30/21, lacked documentation of completion of a drug regimen review. 7. Patient #9 had a start of care date of 8/11/2020. Clinical record review revealed the following: a. The update to the comprehensive assessment at the time of recertification, dated 6/2/21, included a drug regimen review, however lacked documentation of duplicate drug therapy for prescribed medications including Tylenol, Cold/Hot Patches, aspirin, and tramadol (all ordered to treat pain), Symbicort and Pro Air inhalers (ordered for respiratory issues), and Benzotropine, Cyclobenzaprine, Diazepam, Gabapentin, and Promethazine (ordered as central nervous system agents), Januvia and Levemir (ordered for diabetes), Aristada and Sertraline (ordered as antipsychotics). b. The update to the comprehensive assessment at the time of recertification, dated 8/4/21, included a drug regimen review, however lacked documentation of duplicate drug therapy for prescribed medications including Tylenol, Cold/Hot Patches, aspirin, and tramadol (all ordered to treat pain), Symbicort and Pro Air inhalers (ordered for respiratory issues), and Benzotropine, Cyclobenzaprine, Diazepam, Gabapentin, and Promethazine (ordered as central nervous system agents)., Januvia and Levemir (ordered for diabetes), Aristada, Seroquel, and Sertraline (all ordered as antipsychotics). c. The update to the comprehensive assessment at the time of recertification, dated 9/30/21, lacked documentation of completion of a drug regimen review. The above findings were reviewed with agency Administrator and the Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey. According to the agency policy, titled Provision of Care and Record Management and dated 5/2018, the clinical record must include a review of medication history, as applicable to care and service and current medication use. The review must include prescription, over-the-counter medications and herbal medications to determine allergic reactions, identify significant drug interactions, identify duplicative drug therapy, identify potential adverse effects and drug reactions, identify ineffective medications, determine effectiveness of drug therapy, identify any unusual and unexpected effects, identify significant side effects and note any non-compliance with medication therapy. According to the agency policy, titled Medication Profile and dated 11/2018, a drug regimen review will be performed at every comprehensive assessment and as needed. The review will be performed by a qualified clinician and will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy and non-compliance with drug therapy. The clinician will use the medication profile to evaluate the use of medications in the home setting. During agency staff interview on 12/1/2021 at 10:02 AM, Staff B, Clinical Manager, reported agency registered nurses (RNs) complete drug regimen reviews with all new medication orders, with changes to medication orders and at the time of every comprehensive assessment, including initial assessment at start of care, update to the assessment at the time of recertification and significant change in condition, update to the comprehensive assessment at the time of resumption of care and at discharge. 1. Patient #10 had a start of care date of 9/13/2021. Clinical record review revealed the following: a. The drug regimen reviews completed with the initial assessment at the time of start of care, dated 9/13/2021, and the update to the assessment at the time of resumption of care, dated 10/15/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The Plan of Care, dated 9/13/2021 to 11/11/2021, included the medications Clear Lax (polyethylene glycol- a laxative; and docusate sodium- a stool softener); docusate sodium (a stool softener) and magnesium hydroxide (a laxative). The RN failed to identify the duplicate stool softeners and the duplicate laxatives. The RN failed to identify the same medication, docusate sodium, was in two of the medications taken by the patient and failed to identify the potential for diarrhea when all of the medications taken for constipation were taken at the same time. b. The drug regimen reviews completed with the initial assessment at the time of start of care, dated 9/13/2021, and the update to the assessment at the time of resumption of care, dated 10/15/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The Plan of Care, dated 9/13/2021 to 11/11/2021, included the medications Plavix and Low Dose Aspirin, both blood thinners. The RN failed to identify the duplicate blood thinners and failed to identify the potential for abnormal bleeding when combined. c. The update to the comprehensive assessment at the time of discharge, dated 11/11/2021, did not include a drug regimen review. 2. Patient #11 had a start of care date of 9/1/2021. Clinical record review revealed the following: The update to the comprehensive assessment at the time of recertification, dated 10/28/2021, did not include a drug regimen review. 3. Patient #14 had a start of care date of 7/5/2021, was discharged on 10/1/2021 due to nursing home admission following hospitalization and was readmitted on 10/17/2021. Clinical record review revealed the following: a. The drug regimen reviews completed with the initial assessment at the time of start of care, dated 7/5/2021 and 10/17/2021, and the update to the assessment at the time of resumption of care, dated 8/20/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The update to the comprehensive assessment at the time of recertification, dated 9/2/2021, documented the patient took only duplicate sleeping medications. The Plans of Care, dated 7/5/2021 to 9/2/2021, 9/3/2021 to 11/1/2021 and 10/17/2021 to 12/15/2021, included the medications Gabapentin, Vicodin (hydrocodone with acetaminophen) and acetaminophen, all pain medications. The RN failed to identify the duplicate pain medications and failed to identify the same medication, acetaminophen, was in two of the medications taken by the patient. b. The drug regimen reviews completed with the initial assessment at the time of start of care, dated 7/5/2021 and 10/17/2021, and the update to the assessment at the time of resumption of care, dated 8/20/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The update to the comprehensive assessment at the time of recertification, dated 9/2/2021, documented the patient took only duplicate sleeping medications. The Plans of Care, dated 7/5/2021 to 9/2/2021, 9/3/2021 to 11/1/2021 and 10/17/2021 to 12/15/2021, included the medications Lisinopril, Metoprolol and Bumex, all medications taken to lower the blood pressure. The same Plans of Care identified Patient #14 had hypertension. The RN failed to identify the blood pressure medications and the potential for hypotension when all of the blood pressure lowering medications were taken at the same time. c. The drug regimen reviews completed with the initial assessment at the time of start of care, dated 7/5/2021 and 10/17/2021, and the update to the assessment at the time of resumption of care, dated 8/20/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The update to the comprehensive assessment at the time of recertification, dated 9/2/2021, documented the patient took only duplicate sleeping medications. The Plans of Care, dated 7/5/2021 to 9/2/2021, 9/3/2021 to 11/1/2021 and 10/17/2021 to 12/15/2021, included the medications Pramipexole and Carbidopa-Levodopa, both anti-Parkinsonian medications. The same Plans identified Patient #14 had Parkinson's Disease. The RN failed to identify the duplicate anti-Parkinsonian medications. d. The drug regimen reviews completed with the initial assessment at the time of start of care, dated 7/5/2021 and 10/17/2021, and the update to the assessment at the time of resumption of care, dated 8/20/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The Plans of Care, dated 7/5/2021 to 9/2/2021, 9/3/2021 to 11/1/2021 and 10/17/2021 to 12/15/2021, included the medications Trazadone and Duloxetine, both medications to treat insomnia. The RN failed to identify the duplicate sleeping medications. 4. Patient #15, a pediatric patient, had a start of care date of 4/29/2021. Clinical record review revealed the following: a. The update to the comprehensive assessment at the time of recertification, dated 6/25/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The Plans of Care, dated 4/29/2021 to 6/27/2021 and 6/28/2021 to 8/26/2021, included the medications Clorathiazide and Enalapril, both medications taken to lower the blood pressure. The same Plans of Care identified Patient #15 had neonatal hypertension. The RN failed to identify the blood pressure medications and the potential for hypotension when all of the blood pressure lowering medications were taken at the same time. b. The update to the comprehensive assessment at the time of recertification, dated 10/21/2021, did not included a drug regimen review. 5. Patient #17 had a start of care date of 7/30/2021 and was discharged on 11/26/2021. Clinical record review revealed the following: a. The update to the comprehensive assessment at the time of discharge, dated 11/26/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The Plan of Care, dated 9/28/2021 to 11/26/2021, included the medications Topiramate and Gabapentin, both medications taken for nerve pain. The same Plan documented one of Patient #17's diagnoses as chronic pain syndrome. The RN failed to identify the duplicate nerve pain medications. b. The update to the comprehensive assessment at the time of discharge, dated 11/26/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The Plan of Care, dated 9/28/2021 to 11/26/2021, included the medications Vicodin (hydrocodone with acetaminophen), acetaminophen, Excedrin Migraine (Aspirin, Acetaminophen and Caffeine) Advil and Aspirin, all pain medications. The same Plan documented one of Patient #17's diagnoses as chronic pain syndrome. The RN failed to identify the duplicate pain medications and that three of the pain medications included acetaminiophen and two of the pain medications included aspirin. c. The update to the comprehensive assessment at the time of discharge, dated 11/26/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The Plan of Care, dated 9/28/2021 to 11/26/2021, included the medications Wellbutrin, Citralopram, both antidepressants, and diazepam and buspirone, both antianxiety medications. The RN failed to identify the duplicate antidepressants and antianxiety medications. d. The update to the comprehensive assessment at the time of discharge, dated 11/26/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The Plan of Care, dated 9/28/2021 to 11/26/2021, included the medications omeprazole and pepcid, both antiulcer medications. The RN failed to identify the duplicate antiulcer medications. e. The update to the comprehensive assessment at the time of discharge, dated 11/26/2021, documented the review revealed no duplicative medication therapy and no actual or potential medication interactions. The Plan of Care, dated 9/28/2021 to 11/26/2021, included the medications Senna + with docusate sodium (a laxative with stool softener), Senna (a laxative) and Docusate Sodium (a stool softener), all medications taken for constipation. The RN failed to identify the duplicate medications for constipation. The RN failed to identify two of the medications contained Senna and two of the medications contained docusate sodium. The RN failed to identify the potential for diarrhea when all of the bowel medications were combined.

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 and agency policy review, the agency failed to ensure accurate completion of all required components of the recertification comprehensive assessments between day 56 and 60 of each 60 day certification period for 5 of 11 sampled patients requiring a recertification assessment (Patients #4, #10, #12, #14 and #16). The agency reported a census of 194 patients at the time of the extended survey. Failure to accurately and thoroughly complete recertification comprehensive assessments in a timely manner increased the potential that patients might not receive services in a manner to meet individualized patient needs. Findings include: 4. Patient #4 had a start of care date of 2/18/21 and was discharged from agency services on 8/13/21. The patient was readmitted on 8/17/21. Clinical record review revealed an update to the comprehensive assessment for recertification, dated as initiated on 10/13/21, was not electronically signed as completed until 10/19/21, day 4 into the new certification period. The assessment was not completed by day 60 as required by regulation and agency policy, which was 4 days late. The agency lacked completion of the update the comprehensive assessment in the last 5 days of the 60 day episode. 5. Patient #16 had a start of care date of 5/14/19. Clinical record review revealed the following an update to the comprehensive assessment for recertification, dated as initiated on 1028//21, was not electronically signed as completed until 10/30/21, day 1 into the new certification period. The assessment was not completed by day 60 as required by regulation and agency policy, which was 1 day late. The agency lacked completion of the update the comprehensive assessment in the last 5 days of the 60 day episode. The above findings were reviewed with the Agency Administrator and the Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey. According to the agency policy, titled Initial and Comprehensive Assessment and dated 5/2018, each patient will have a comprehensive assessment completed in the last five days of every 60-day period beginning with the start of care date for recertification if continued services are planned. According to the agency policy, titled Reassessments/Recertification and dated 2/2014, for each new episode of care (certification period), a comprehensive assessment will be completed no earlier than 5 days before and no later than one day before the calendar day on with the new episode of care will begin. 1. Patient #10 had a start of care date of 9/13/2021. Clinical record review revealed the following: a. The Plans of Care, dated 9/13/2021 to 11/11/2021 and 11/12/2021 to 1/10/2022, included physician orders for skilled nursing, physical therapy, occupational therapy, medical social work and home health aide services. b. The update to the comprehensive assessment at the time of recertification was begun on day 60 of the certification period (11/11/2021); however, was not completed until 11/13/2021, two days into the new certification period, making the assessment 2 days late. 2. Patient #12 had a start of care date of 3/19/2021. Clinical record review revealed the following: a. The Plans of Care, dated 7/17/2021 to 9/14/2021 and 9/15/2021 to 11/13/2021, included physician orders for skilled nursing and home health aide services. The update to the comprehensive assessment at the time of recertification was begun on day 56 of the certification period (9/10/2021); however, was not completed until 9/24/2021, 10 days into the new certification period, making the assessment 10 days late. b. The Plans of Care, dated 9/15/2021 to 11/13/2021 and 11/14/2021 to 1/12/2022, included physician orders for skilled nursing and home health aide services. The update to the comprehensive assessment at the time of recertification was begun on day 59 of the certification period (11/12/2021); however, was not completed until 11/18/2021, 5 days into the new certification period, making the assessment 5 days late. 3. Patient #14 had a start of care date of 7/5/2021. Clinical record review revealed the following: a. The Plans of Care, dated 7/5/2021 to 9/2/2021 and 9/3/2021 to 11/1/2021, included physician orders for skilled nursing, physical therapy, occupational therapy, medical social work and home health aide services. b. The update to the comprehensive assessment at the time of recertification was begun on day 60 of the certification period (9/2/2021); however, was not completed until 9/3/2021, one day into the new certification period, making the assessment 1 day late.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on clinical record review, the agency failed to ensure completion of the update to the comprehensive assessment within 48 hours of the agency's knowledge of the patient's need to discharge for 2 of 3 sampled patients requiring a discharge comprehensive assessment (Patients #4 and #18). The agency provided services to 194 patients at the time of the extended survey and performed 143 discharge comprehensive assessments in the previous 6 months. Failure to complete a discharge comprehensive assessment in a timely manner increased the potential that patients might not receive services in a manner to meet individualized patient needs. Findings include: 1. Patient #4 had a start of care date of 2/18/21 and was discharged from agency services on 8/13/21. Clinical record review revealed an update to the comprehensive assessment for discharge, dated as initiated on 8/13/21, was not electronically signed as completed until 8/16/21, exceeding the regulation requirement by 1 day. The assessment was not completed within 48 hours of the agency's knowledge of the patient's need to discharge as required by regulation and agency policy, which was 1 days late. 2. Patient #18 had a start of care date of 7/9/21 and was discharged from agency services on 11/12/21. Clinical record review revealed an update to the comprehensive assessment for discharge, dated as initiated on 11/12/21, was not electronically signed as completed until 11/15//21, exceeding the regulation requirement by 1 day. The assessment was not completed within 48 hours of the agency's knowledge of the patient's need to discharge as required by regulation and agency policy, which was 1 days late. The surveyors reviewed the above findings with the agency Administrator and the Chief of Organizational Performance. 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, review of the agency’s complaint log, surveyor observation, patient interview and agency staff interview, the agency was not operating in compliance with the Condition of Participation for the following reasons: 1) failed to ensure all supplies/equipment/medications/treatments required by the patient to meet his/her needs were included on each patient's Plan of Care (G574); 2) failed to provide medications, treatments and services only as ordered by a physician (G580); 3) failed to promptly alert the relevant physician(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or the plan of care should be altered (G590); and 4) failed to coordinate patient care in an individualized manner to meet the needs of the patient (G608). 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 206 patients during the initial complaint survey and 194 patients at the time of the extended 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 agency policy review, clinical record review, home visit observation and patient interview, the agency failed to ensure the accurate completion of all components comprising the Plan of Care, including inclusion of all supplies/equipment and medications used by the patient for 4 of 7 sampled patients (Patients #4, #9, #10 and #14). The agency reported a total current census of 194 at the time of the extended survey. 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: 3. Patient #9 had a start of care date of 8/11/2020. Clinical record review revealed the following: a. The Plans of Care, dated 8/6/21 to 10/4/21, included orders for Dicyclomine 10 mg twice daily as needed. The Plan did not include the reason for the as needed medication to be given. b. The Plans of Care, dated 8/6/21 to 10/4/21 and 10/5/21 to 12/3/21, included orders for Cyclobenzaprine 10 mg twice daily as needed and Tramadol 10 mg every six hours as needed. The Plans of Care did not include the reason for the as needed medication to be given. c. The Plan of Care, dated 10/5/21 to 12/3/21, identified the following equipment and supplies used to meet the patient's needs: blood pressure cuff, cane, compression socks, CPAP (continouse positive airway pressure machine), glucometer, grab bars, lancets, medication planner, pill splitter, pulse oximeter, scale, shower chair, testing strips, knee elbow sleeve, needles/syringes for intramuscular injection, thermometer, heading pad, and gloves. During a home visit observation on 11/30/21 at 3:30 PM, the surveyor accompanied Staff D, Registered Nurse (RN) to Patient #9's home. The patient reported use of a reacher for assistance to obtain items. The patient received the reacher 1 month ago. e. The Plan of Care, dated 10/5/21 to 12/3/21, lacked identification of the reacher as equipment used to meet the patient's needs. f. The Plans of Care, dated 8/6/21 to 10/4/21 and 10/5/21 to 12/3/21, included orders for Humalog Kwikpen insulin 100 units per milliliter (ml) with an ordered dose of 6 units with meals three times per day. During the same home visit observation, the surveyor reviewed the patient's medications with the patient and the nurse. The patient reported use of 10 units since August. The Plans of Care, dated 8/6/21 to 10/4/21 and 10/5/21 to 12/3/21, lacked identification of the correct dosage of insulin being used by the patient g. The Plans of Care, dated 8/6/21 to 10/4/21 and 10/5/21 to 12/3/21, included orders for Lidocaine patch 4% daily as needed for pain. During the same home visit observation the patient reported no longer having any patches and reported no use for 2-3 months. The Plans of Care, dated 8/6/21 to 10/4/21 and 10/5/21 to 12/3/21, identified the Lidocaine patches as medication used by the patient. 4. Patient #4 had a start of care date of 2/18/21 and a discharge date of 8/13/21. The patient was readmitted to the agency on 8/17/21. Clinical record review revealed the following: The Plans of Care, dated 8/17/21 to 10/15/21 and 10/16/21 to 12/14/21, ordered the use of Tramadol 50 mg three times per day as needed and Cyclobenzaprine 10 mg three times per day as needed. The Plans of Care failed to identify the reason the as needed medication was to be given. The above findings were reviewed with the Administrator and the Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey. According to agency policy, titled Physician Participation in Plan of Care and dated 4/2019, patient care will be provided in compliance with physician orders and accepted standards of practice. Physician orders will be individualized, based on patient needs and include..... treatments and/or procedures needed, including type, frequency, duration and goals; medications to be administered and/or monitored and a description of equipment and related supplies. According to the agency policy, titled Care Planning Process and dated 4/2019, The Plan of Care will be individualized and discipline specific. The Plan will include.....medications taken by the patient, including dose/frequency/route; supplies and equipment required. 1. Patient #10 had a start of care date of 9/13/2021. Clinical record review, home visit surveyor observation and associated interviews revealed the following: a. On 12/1/2021 at 3:30 PM the surveyor accompanied Staff E, Physical Therapist, to Patient #10's home. During the home visit, the surveyor observed the patient sitting in a lift chair with an egg crate foam cushion placed on top of the chair seat. The surveyor also observed the patient had a heating pad placed across his/her back. b. During patient interview while in the patient's home, Patient #10 reported having surgery on his/her back approximately 4 to 5 years ago. Since that time, the cushion and the heating pad use are the only things that relieve the pain in the back when sitting. c. The Plans of Care, dated 9/13/2021 to 11/11/2021 and 11/12/2021 to 1/10/2022, did not include the foam egg crate cushion of the heating pad as equipment used by the patient to meet his/her needs. 2. Patient #14 had a start of care date of 7/5/2021; was discharged from the agency due to nursing home admission following hospitalization on 10/1/2021and readmitted to home health on 10/17/2021. Clinical record review revealed the following: a. The Plan of Care, dated 9/3/2021 to 11/1/2021, included orders for physical therapy visits once weekly for 9 weeks and 4 preapproved PRN (as needed) physical therapy visits. The Plan did not include the preapproved reason for the PRN therapy visits. b. The Plan of Care, dated 9/3/2021 to 11/1/2021, included physician orders for the patient's use of an 18 French catheter but the order on the Plan of Care lacked identification of the size of bulb and the amount of sterile water needed for inflation of the catheter bulb.

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 only as ordered by the physician for 2 of 3 sampled patients receiving administration of injectable medications by an agency nurse (Patients #1 and #8). The agency reported a current patient census of 206 patients at the time of the initial complaint survey and 194 at the time of the extended survey. 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: According to agency policy, titled Care Planning Process and dated 4/2019, the Plan of Care will be individualized and discipline specific. The Plan of Care will be based upon the physician's orders. 1. Patient #1, a pediatric patient, had a start of care date of 4/21/21. Clinical record review revealed the following: a. The Plans of Care, dated 8/19/2021 to 10/17/2021, documented the nurse or patient will administer Crysvita, an injectable medication used to treat familial low phosphorus/Vitamin D in the blood every 28 days. b. On 9/13/2021, the physician returned the Plan of Care with the word "patient" removed from the orders for the Crysvita administration. The physician noted at the bottom of the Plan of care that the medication should only be administered by a healthcare professional. c. The skilled nurse visit notes, dated 7/14/2021, documented administration of the Crysvita by injection. d. The care coordination note, dated 8/9/2021, documented the nurse called the patient’s home to schedule a visit for the next injection on 8/10/2021, which would have been one day early and the patient had not yet received the medication for injection. The registered nurse decided to administer the medication during the upcoming recertification assessment. e. The update to the comprehensive assessment at the time of recertification, dated 8/18/2021, documented the nurse administered the Crysvita by injection, 35 days after the last injection. f. The skilled nurse visit note, dated 9/8/2021, documented the nurse administered the Crysvita by injection. The injection was done only 21 days after the last injection. g. The skilled nurse visit note, dated 10/7/2021, documented the nurse administered the Crysvita by injection. The injection was done 29 days after the last, 1 day late. h. The patient’s clinical record lacked any physician orders changing the frequency for administration of the Crysvita injections. The agency nurses failed to follow the physician orders when administering the patient's injectable Crysvita. 2. Patient #8 had a start of care date of 6/21/21. Clinical record review revealed the following: a. The Plan of Care, dated 8/20/2021 to 10/18/2021, included physician orders to administer the B12 injection every 28-30 days. b. The skilled nurse visit, dated 8/3/2021, documented the nurse administered the B12 injection. c. The skilled nurse visit, dated 9/10/2021, documented the nurse administered the B12 injection, 38 days later. d. The skilled nurse visit, dated 10/14/2021, documented the nurse administered the B12 injection, 34 days later. e. The clinical record lacked any physician orders changing the frequency of administration of the B12 injections. The agency nurses failed to follow the physician orders when administering the patient's injectable Vitamin B12. The above stated findings were reviewed with the Administrator and the Chief of Organizational Performance. The agency provided no additional information prior to the end of the survey.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on agency policy review, review of the agency's complaint log, clinical record review and agency staff interview, the agency failed to report changes in patient clinical findings or changes in patient needs to the physician to obtain direction and/or failed to notify the physician of the inability to follow the Plan of Care for 5 of 14 sampled patients (Patients #1, #4, #5, #7 and #8). The agency provided services to 206 patients at the time of the initial complaint survey and 194 patients at the time of the extended survey. Failure to communicate the patient's status with the physician placed agency patients at risk for unidentified worsening of conditions, inappropriate treatments, or unmet home health care needs. Findings include: 3. Patient #5 had a start of care date of 6/16/2021. The Plan of Care, dated 8/15/21 to 10/14/21, included orders for skilled nursing weekly and physical therapy twice weekly. Clinical record review revealed: a. The physical therapy missed encounter report, dated 10/13/12, documented the patient refused a visit due to increased blood pressure and hip pain. b. The update for the comprehensive assessment, dated 10/13/21, documented the patient’s blood pressure readings at the time of assessment were lying and sitting 138/76 and standing 122/72 and pain. On 11/3/21 at 8:40 AM interview with Staff E, Physical Therapist (PT), revealed the physical therapist did not contact the nurse or the physician, as the nurse had already visited that patient that day and the therapist believed the nurse was already aware of the elevated blood pressure and hip pain. c. A missed visit note, dated as completed by office staff on 10/13/21, was not sent to the physician until 10/19/21 by the office staff. The clinical record lacked documentation of the agency communicating the elevated blood pressure and hip pain with the Plan of Care physician. 4. Patient #7 had a start of care date of 10/14/2021. The Plan of Care, dated 10/14/21 to 12/12/21, included orders for skilled nursing and home health aide services. Clinical record review revealed: a. Missed home health aide visit notes, dated 10/15/21, 10/22/21, and 10/26/21, documented the patient’s refusal of the home health aide visits. b. Home health aide visit notes, dated 10/19/21 and 10/29/21, documented the patient refused all personal care tasks and allowed only the task of encouraging fluids to be completed by the home health aide. The clinical record failed to include documentation of the agency communicating the refusal of personal cares for every scheduled visit since the start of care with the Plan of Care physician. c. The initial comprehensive assessment completed at start of care, dated 10/14/21, documented the patient’s weight of 130 pounds. d. The LPN visit note, dated 11/1/21, documented the patient’s weight of 120 pounds, a weight loss of 10 pounds in 18 days. The clinical record failed to include documentation of the agency communicating weight loss with the Plan of Care physician. The above findings for Patients #1, #5, #7, and #8 were reviewed with agency Administrator and Staff B, Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey. According to the agency policy, titled Care Planning Process and dated 4/2019, the patient and family/caregiver will participate in decisions regarding the Plan of Care. The Plan of Care will be individualized and discipline specific. The Plan of Care will include all patient care orders, including verbal orders. Clinicians will inform the patient's physician of any changes that suggest a need to alter the Plan of Care. Changes must be written, dated and signed by the professional making the changes. In the event the patient visits are provided less than ordered on the Plan of Care, the agency will consider the reason for the missed visit and the potential/actual impact to the patient. The physician will be updated timely by the clinician if there is an actual/potential significant impact on the patient's health and/or medical treatment. The agency may wait until the completion of the 60 day cert period and related performance improvement process to communicate missed visits to the physician when there is no significant impact. The missed visit notification, when there is no actual/potential significant impact to the patient's health or medical treatment may be communicated by a non-clinical staff member. During agency staff interview on 11/2/2021 at 3:55 PM, the Administrator/Clinical Manager reported all agency staff document contact with patient physicians in the coordination notes, journal notes, missed visit notes or in the visit note itself. Review of the agency’s complaint file revealed only one complaint since the last survey. The complaint was dated 11/1/2021 and related to Patient #1 and filed with the agency by the pharmacy suppling the Crysvita. The pharmacist reported a concern that the agency was attempting to have the pediatric patient and her parents learn to self administer Burosumab-twza (Crysvita), a medication used to treat familial hypophosphatemia (Ricketts). The complaint reported knowledge that the patient's parents and the physician planned to issue a complaint to the agency as the medication manufacturer directs the medication should be administered every 28 days subcutaneously by health care professionals only. 1. Patient #1, pediatric patient, had a start of care date of 4/21/2021. Clinical record review revealed the following: a. The Plans of Care, dated 8/19/2021 to 10/17/2021, documented the nurse or patient will administer Crysvita, an injectable medication used to treat familial low phosphorus/Vitamin D in the blood, every 28 days. The interventions described education to the patient and caregiver related to the techniques for self-administration and the goal was set for the patient to be able to demo self-administration by the end of the certification period. On 9/13/2021, the physician returned the Plan of Care with the word "patient" removed from the orders for the Crysvita administration. The physician noted at the bottom of the Plan that the medication should only be administered by a healthcare professional. The original signed copy was corrected; however, the nurse did not update the order in the electronic system. b. An LPN saw the patient on 9/8/2021 and 10/7/2021. The intervention to educate remained in the skilled nurse interventions. On 10/7/2021, the LPN wrote an updated order to reflect a changed date for the next scheduled injection. When doing so, the old order verbiage directing the nurse to educate on self administration and approval for the patient to self-inject reappeared. The order was sent to the physician. c. On 10/29/2021, the physician returned the order again with the order corrected to reflect only the nurse should administer the Crysvita; removed the intervention to educate on self-administration and removed the goal to have the patient successfully self-administer by the end of the cert. The physician also sent a copy of the manufacturer's guidance/directions. The Crysvita manufacturer directions specifically stated the administration of the medication should be done by a health care professional. d. A new Plan of Care, dated 10/18/2021 to 12/16/2021, was also sent out with all of the remaining incorrect information previously removed from the last Plan of Care. The agency did not correct the physician orders in the electronic medical record until 11/1/2021 after the pharmacy complained and the Administrator talked with both the parent and the physician as part of the complaint resolution. During agency staff interview on 11/2/2021 at 8:25 AM, Staff D, Registered Nurse (RN) reported she took over as case manager for Patient #1 in August 2021. The RN decided to start teaching the patient how to self-inject the Crysvita, as the patient was a junior in highschool and had plans to go to college. The RN reported she contacted the physician’s office and spoke to the physician’s nurse who agreed with the addition of the tasks/goals. During the 8/18/2021 visit, the RN reported performing the injection with both the patient and the parent observing. The RN explained each step and did instruct both to practice on an orange before attempting to administer the actual injection. During agency staff interview on 11/2/2021 at 9:05 AM, Staff C, Licensed Practical Nurse (LPN) reported she had visited Patient #1 twice to give the injections. During the first visit, the LPN did not do any education; injecting the Crysvita as the patient had plans and was in a hurry. During the second visit, the LPN attempted to educate but the patient reported feeling uncomfortable and did not want to be taught to self-administer the medication. The LPN reported putting in a physician’s order on 10/7/2021 to update the date of the next scheduled injection but everything else on the order populated from the orders entered into the agency’s electronic medical record system. e. The skilled nurse visit notes, dated 7/14/2021, documented administration of the Crysvita by injection. f. The care coordination note, dated 8/9/2021, documented the nurse called the patient’s home to schedule a visit for the next injection on 8/10/2021, which would have been one day early and the patient had not yet received the medication for injection. The registered nurse decided to inject the medication during the upcoming recertification assessment. The update to the comprehensive assessment at the time of recertification, dated 8/18/2021, documented the nurse administered the Crysvita by injection, 35 days after the last injection. The agency completed a missed visit note on 8/14/2021 and sent the note to the physician by facsimile on 8/20/2021. The clinical record lacked any documentation of coordination with the physician to report the need to alter the Plan of Care. g. The skilled nurse visit note, dated 9/8/2021, documented the nurse administered the Crysvita by injection. The injection was done only 21 days after the last injection. The clinical record lacked any documentation of communication with the physician to approve the administration of the Crysvita on the original planned schedule even though the previous dose was delayed. 2. Patient #8 had a start of care date of 6/21/21. Clinical record review revealed the following: a. The Plan of Care, dated 8/20/2021 to 10/18/2021, included physician orders to administer the B12 injection every 28-30 days. b. The skilled nurse visit, dated 8/3/2021, documented the nurse administered the B12 injection. c. The skilled nurse visit, dated 9/10/2021, documented the nurse administered the B12 injection, 38 days later. The clinical record lacked any documentation of communication with the physician to report the inability to complete the injection as ordered and obtain direction on how to proceed. d. The skilled nurse visit, dated 10/14/2021, documented the nurse administered the B12 injection, 34 days later. The clinical record lacked any documentation of communication with the physician to report the inability to complete the injection as ordered and obtain direction on how to proceed.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on clinical record review, the agency failed to ensure agency staff coordinated care in a way to meet patient individualized needs for 2 of 7 sampled patients (Patients #9 and #10). The agency reported a current census of 194 patients at the time of the extended survey. Failure to ensure agency staff effectively coordinated the delivery of care resulted in the potential patients may not receive care to meet individualized needs. Findings include: According to the agency policy, titled Provision of Care and Record Management and dated 5/2018, the baseline data will be documented in the patient's clinical record and include the presence of any advance directives for care or discussions with the patient and, as appropriate, family/caregiver, regarding the withholding of resuscitative services or the withdrawal of life-sustaining treatment. 1. Patient #9 had a start of care date of 8/11/2021. Clinical record review revealed the following: a. The Plans of Care, dated 6/7/2021 to 8/5/2021, 8/6/2021 to 10/4/2021 and 10/5/2021 to 12/3/2021, documented the patient's code status as do not resuscitate (DNR). All three Plans of Care were signed by the physician. b. The patient's electronic clinical record Profile Page documented the patient's code status as full code, requiring staff to begin cardio-pulmonary resuscitation (CPR) if the patient was found with no pulse or respirations. The electronic clinical record Profile Page did not reflect the patient's wish for no resuscitation. 2. Patient #10 had a start of care date of 9/13/2021. Clinical record review revealed the following: a. The Plans of Care, dated 9/13/2021 to 11/11/2021 and 11/12/2021 to 1/10/2022, documented the patient's code status as do not resuscitate (DNR). Both Plans of Care were signed by the physician. b. The patient's electronic clinical record Profile Page documented the patient's code status as full code, requiring staff to begin cardio-pulmonary resuscitation (CPR) if the patient was found with no pulse or respirations. The electronic clinical record Profile Page did not reflect the patient's wish for no resuscitation. The above findings were reviewed with the agency Administrator and the Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey.

Org. had partial/extended survey CFR(s): 484.80(f)(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or This ELEMENT is not met as evidenced by: Based on agency staff personnel file review and agency staff interview, the agency failed to abide by the CMS imposed prohibition to train and competency test new home health aides as a result of having Conditions of Participation out of compliance following a previous complaint survey on 8/4/2021. The agency trained and competency tested 2 of 2 sampled newly hired home health aides (Staff G and F) using it's own direct employee and a corporate employee, thereby failing to comply with the prohibition. The agency had hired 3 home health aides after 8/4/2021. Findings include: During the agency's previous complaint, dated 8/4/2021, the survey found the agency operating out of compliance with the Condition of Participation 42 CFR 484.60 Care Planning, Coordination and Quality of Care. The agency was notified by letter, dated 8/12/2021, of the non-compliance. The letter explained the agency's registered nurses (RNs) were prohibited from training and competency testing any newly hired home health aides after 8/4/2021 for a period of 2 years, ending on 8/4/2023. Agency staff personnel file review revealed the following: 1. Staff G, a home health aide, had a hire date of 9/29/2021. Staff G's personnel file included a copy of the written test used by the agency to determine general basic skills competency in communication, observation/reporting, infection control, maintenance of a clean safe and healthy environment, recognizing emergencies and knowledge of emergency procedures, physical emotional and developmental needs re: privacy and property, and nutrition/fluid intake. The test, dated as given on 9/29/21, had been scored and marked satisfactory by the agency's own RN (Registered Nurse)/Administrator. 2. Staff F, a home health aide, had a hire date of 11/15/2021. Staff F's personnel file included a copy of the written test used by the agency to determine general basic skills competency in communication, observation/reporting, infection control, maintenance of a clean safe and healthy environment, recognizing emergencies and knowledge of emergency procedures, physical emotional and developmental needs re: privacy and property, and nutrition/fluid intake. The test, dated as given on 11/16/2021, had been scored and marked satisfactory by the agency's RN/Corporate Director of Staff and Development. The personnel file also included documentation of RN observance of return demonstration reading/recording temperature/pulse/respirations, bath bed/sponge/tub/shower, shampoo bed/sink/tub, nail care, skin care, oral hygiene, safe transfer techniques, ambulation, range of motion, toileting/elimination, recognizing/reporting skin conditions and communication skills, by Staff F, Home Health Aide. The document was dated 11/16/2021 and signed by the agency's RN/Corporate Director of Staff and Development. During agency staff interview on 12/1/2021 at 1:57 PM, the Administrator provided a copy of the CMS letter, dated 8/12/2021, which described the agency's prohibition. She reported knowledge of the prohibition but felt since Staff G, Home Health Aide, was a certified nurse aide, it would be okay to train/competency test the aide even though prohibited to do so. The Chief of Organizational Performance was present during the interview. The Chief of Organizational Performance told the Administrator she went above and beyond and shouldn't have. During agency staff interview on 12/1/2021 at 2:23 PM, the Chief of Organizational Performance reported the Corporate Director of Staff and Development did competency for everyone in the Corporation. During agency staff interview on 12/1/2021 at 2:35, the Chief of Organizational Performance clarified she contacted the agency's human resources and found the Corporate Director of Staff and Development was both on the payroll as a Corporate Employee. He also worked for the training company, American Institute of Caring (AIC), which is owned by the same owner of the Corporation. The Corporate Director of Staff and Development was currently filling in for the trainer at AIC who recently quit. Staff G and F, both home health aides were trained and competency tested by the agency's own RNs after CMS imposed a prohibition for agency RNs to train and competency test newly hired home health aides; thereby, not abiding by the CMS imposed prohibition. On 12/1/2021 at approximately 4:40 PM, the above findings were reviewed with the Administrator and the Chief of Organizational Performance. The agency presented no further information prior to the end of the survey.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on clinical record review and agency policy review, the agency failed to provide individualized and specific written patient care instructions from a registered nurse (RN) to agency home health aides for 4 of 6 sampled patients receiving home health aide services (Patients #4 #12, #14 and #16). The agency reported a census of 194 patients at the time of the extended survey, including 45 who received home health aide services. Failure to ensure agency registered nurses provided patient specific written instructions directing the care provided by the agency's home health aides for each patient increased the risk agency patient's would receive inappropriate or inconsistent home health aide services. Findings include: According to the agency policy, titled Home Health Aide Assignment Record and dated 2/2015, the home health aide assignment will be individualized to the specific patient needs and will include the types of services/procedures to be provided, including the amount, frequency and duration necessary to meet the needs of the patient. The aide assignment will be reviewed and updated at least every 60 days based upon the professional reassessment of the patient and at any time the patient's needs change or warrant revision. 1. Patient #14 had a start of care date of 7/5/2021, was discharged due to nursing home admission following hospitalization on 10/1/2021 and readmitted to home health services on 10/17/2021. Clinical record review revealed the following: a. The Plan of Care, dated 9/3/2021 to 11/1/2021, included physician orders for the nurse, caregiver or home health aide to cleanse the patient's lower legs with soap and water, pat dry and leave open to air due to exacerbation of lymphedema to both legs. The Plan of Care also included direction for the skilled nurse, caregiver or home health aide to lightly dust the patient's breast folds and abdominal folds with Nystatin powder, an antifungal powder. The home health aide assignment, dated 9/3/2021, lacked direction to the aide to cleanse and pat dry the patient's lower legs and lacked direction to the aide to lightly dust the breast folds and abdominal folds of the patient with Nystatin powder. b. The home health aide assignments, dated 8/20/2021 and 9/3/2021, included direction for the home health aide to perform "nail care every visit" and "foot care every visit". The assignments did not clarify what the aide was to perform to be considered nail care and foot care . The patient's home health aide assignments were not specific nor individualized to meet Patient #14's needs. 2. Patient #4 had a start of care date of 2/18/2021, was discharged from services on 8/13/2021 due to a funding source change, and readmitted on 8/17/2021. Clinical record review revealed the following: The home health aide assignment, dated 6/17/2021, 8/17/2021, included direction for the home health aide to perform "nail care every visit" and "foot care every visit". The assignments did not clarify what the aide was to perform to be considered nail care and foot care . The patient's home health aide assignments were not specific nor individualized to meet Patient #4's needs. 3. Patient #12 had a start of care date of 3/19/2021. Clinical record review revealed the following: The home health aide assignments, dated 9/10/2021 and 11/12/2021, directed the home health aide to assist the patient with a shower and assist the patient with a partial bath. The assignment lacked direction and parameters for the aide to use to determine when a shower should be completed and when a partial bath should be completed. The home health aide assignment was not specific and individualized to Patient #12's needs. 4. Patient #16 had a start of care date of 5/14/2019. Clinical record review revealed the following: a. The home health aide assignments, dated 7/2/2021 and 8/31/2021, included direction for the home health aide to perform "foot care every visit". The assignments did not clarify what the aide was to perform to be considered foot care . b. The home health aide assignments, dated 8/31/2021, included direction for the home health aide to perform "nail care every visit". The assignments did not clarify what the aide was to perform to be considered nail care . The patient's home health aide assignments were not specific nor individualized to meet Patient #16's needs. The above findings were reviewed with the agency Administrator and the Chief of Organizational Performance. 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 agency policy review and clinical record review, 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 2 of 6 sampled patients receiving home health aide services (Patients #4 and #14). The agency reported a current census of 194 patients at the time of the extended survey, including 45 who received care provided by a home health aide. 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 including: According to agency policy, titled Physician Participation in Plan of Care and dated 4/2019, patient care will be provided in compliance with physician orders and accepted standards of practice. Physician orders will be individualized, based on patient needs and include..... treatments and/or procedures needed, including type, frequency, duration and goals. 1. Patient #14 had a start of care date of 7/5/2021 and was discharged from agency services due to nursing home admission following hospitalization on 10/1/2021. The patient was later readmitted on 10/17/2021 and continued to receive services from the agency at the time of the survey. Clinical record review revealed the following: a. The home health aide assignment, dated 9/3/2021, included direction to the home health aide to perform urinary catheter care every visit. Urinary catheter care is an extra skill delegated to the home health aide as an extension of nursing services. The Plan of Care, dated 9/3/2021 to 11/1/2021, included physician orders for the patient to have a urinary catheter; however, did not give approval for the home health aide to perform urinary catheter care as an extension of nursing services. The aides performed catheter care as assigned by the registered nurse but not as approved by the physician. b. The home health aide assignment, dated 8/20/2021, directed the home health aide to shampoo/brush the patient's hair every visit. The home health aide visit notes, dated 8/26,30/2021; and 9/2/2021, documented the home health aide omitted the shampoo/brushing of the patient's hair due to "completion of only a partial bath". Shampooing and brushing the hair are assigned every visit and do not give direction to the aide to omit when completing a partial bath. The aide did not follow the assignment for Patient #14. 2. Patient #4 had a start of care date of 2/18/2021 and was discharged from agency services due to funding source change on 8/13/2021 and was readmitted on 8/17/2021 and continued to receive services from the agency at the time of the survey. Clinical record review revealed the following: a. The home health aide visit notes, dated 11/4/2021,11/17/2021, 11/19/2021 and 11/26/2021, documented the aide applied an orthotic brace. Application of an orthotic brace is an extra skill delegated to the home health aide as an extension of nursing services. b. The Plan of Care, dated 10/16/2021 to 12/14/2021, lacked physician approval for the home health aide to apply the orthotic brace as an extension of nursing services. The aides applied the brace even though the physician had not approved it. The above findings were reviewed with the agency Administrator and the Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey.

Non-skilled direct observation every 60 days CFR(s): 484.80(h)(2) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, the registered nurse must make an on-site visit to the location where the patient is receiving care no less frequently than every 60 days 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 agency policy review and clinical record review, the agency failed to ensure the registered nurse (RN) completed home health aide supervision at least every 60 days while observing the home health aide present and providing direct patient care for 1 of 1 sampled patients who received hands on personal care services with no skilled service provision. (Patient #16). The agency reported a current census of 194 patients at the time of the extended survey, including 1 patient who received personal care assistance by a home health aide without any skilled service provision. Failure to supervise home health aide services, at least every 60 days while the aides provided direct patient care, increased the risk that patients received unsatisfactory or inappropriate care from home health aides. Findings include: According to the agency policy, titled Responsibilities/Supervision of Clinical Services and dated 6/2018, the patient will be contacted monthly and a direct observation supervisory visit will be completed on-site every 60 days. Patient #16 had a start of care date of 5/14/2019. Clinical record review revealed the following: a. The Plan of Care, dated 5/3/2021 to 7/1/2021; 7/2/2021 to 8/30/2021 and 8/31/2021 to 10/29/2021, included physician orders for home health aide visits 3 times per week with supervision of a registered nurse every 60 days. b. The clinical record included documentation of a supervisory visit conducted by an RN on 6/30/2021 from 12:45 PM to 1:30 PM. The supervisory visit documented the home health aide was not present during the visit. The home health aide visit note, dated 6/30/2021, documented the aide was present in the patient's home and providing personal care from 10:45 AM to 11:44 AM. c. The clinical record included documentation of a supervisory visit conducted by an RN on 8/27/2021 from 2:00 PM to 3:00 PM. The supervisory visit documented the home health aide was not present during the visit. The home health aide visit note, dated 8/27/2021, documented the aide was present in the patient's home and providing personal care from 10:41 AM to 11:41 AM. d. The clinical record included documentation of a supervisory visit conducted by an RN on 10/28/2021 from 12:48 PM to 2:27 PM. The supervisory visit documented the home health aide was not present during the visit. The clinical record lacked documentation of any home health aide visit on 10/28/2021. e. The clinical record lacked any other documentation of an RN directly observing the home health aide providing personal care to Patient #16 between 6/30/2021 through the time of the survey, on 12/7/2021. The above findings were reviewed with the agency Administrator and the Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on agency policy review, clinical record review, surveyor observation and agency staff interview, the agency was not operating in compliance with the Condition of Participation for the following reasons: 1) failed to send completed transfer summaries with a medication list to the physician treating the patient during the transfer within 2 business days of knowledge of the transfer and/or failed to send completed discharge summaries with a medication list to the physician and other health care professionals caring for the patient upon discharge from the agency within 5 business days of the actual discharge. (G1022); and 2) failed to store patient clinical record information in a secure and confidential manner to prevent unauthorized access G1028). The cumulative systemic practices resulted in the failure to ensure the organizational framework of the agency to coordinate safe, effective individualized care to the agency's 194 patients at the time of the extended survey.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review and agency staff interview, the agency failed to complete and send a transfer summary to the physician caring for the patient at the inpatient facility after transfer within 2 business days of the patient's transfer and/or failed to complete and send a discharge summary to the physician and other health care professionals who would be providing care to the patient after discharge within 5 calendar days for 2 of 5 sampled patients with transfers/ discharges (Patients #4 and #10). The agency reported a current census of 194 patients at the time of the extended survey. The agency discharged 143 patients in the previous 6 months and performed 46 transfers with resumptions of care. Failure to send the physician and other health care professionals a summary of the patient's care while receiving services from the agency in a timely manner may result in inadequate or inappropriate follow-up during inpatient care or after discharge. Findings include: According to the agency policy, titled Discharge and/or Transfer Criteria and Process and dated 4/2018, a copy of the discharge summary will be sent to the physician within 5 business days of the patient's discharge. According to the agency policy, titled Discharge Summary and dated 5/2018, a copy of the discharge summary will be provided to the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient upon home health discharge within 5 business days of the patient's discharge. The agency did not provide the surveyors with a policy related to transfer summary requirements. During agency staff interview on 12/1/2021 at 4:40 PM, the Administrator reported all transfer summaries and discharge summaries are attached to the discharge order then sent to the physician; however, there is no agency policy stating this. 1. Patient #10 had a start of care date of 9/13/2021. Clinical record review revealed the following: a. The Plan of Care, dated 9/13/2021 to 11/11/2021, included physician orders for skilled nurse visits 3 times weekly for 3 weeks; twice weekly for 2 weeks; then once weekly for 4 weeks. The same Plan included physician orders for physical therapy visits twice weekly for 9 weeks and occupational therapy visits twice weekly for 9 weeks. The same Plan included physician orders for medical social work visits weekly for 9 weeks. b. The Transfer Assessment, dated 10/7/2021, documented the patient was admitted in patient to the hospital on 10/6/2021. c. The update to the comprehensive assessment at the time of resumption of care, dated 10/15/2021, documented the patient was hospitalized from 10/6/2021 until discharged from the inpatient facility on 10/14/2021. d. The patient's clinical record included a transfer summary, dated 10/7/2021, attached to the physician's order for holding services and a medication list current at the time of the transfer; however, the note/order/medication list were not sent to the physician until 11/3/2021, 19 business days after the agency had knowledge of the patient's transfer. 2. Patient #4 had a start of care date of 2/18/2021 and was discharged from agency services on 8/13/2021. Clinical record review revealed the following: a. The update to the comprehensive assessment at the time of discharge was dated as completed on 8/13/2021. b. The patient's clinical record included a discharge summary, dated 8/13/2021; however, the summary was not sent to the physician until 8/30/2021, 11 business days after the agency had knowledge of the patient's need for discharge. The above findings were reviewed with the agency Administrator and the Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on surveyor observation, agency policy review and agency staff interview, the agency failed to ensure that all patient clinical record documentation was maintained in a secure and confidential manner for 188 patients either currently receiving home care services from the agency and/or received home care services in the past. The agency reported a current census of 194 patients at the time of the extended survey. Failure to maintain secured clinical record information increased the risk of a breach in confidentiality related to patient information. Findings include: According to agency policy, titled Management and Retention of Clinical/Administrative/Financial/Personnel Records and dated 2/2020, all active (open) records will be filed alphabetically and stored in a secure area with access by approved personnel only. When a patient discharges or dies, the originals of all clinical/service record documentation will be submitted, reviewed for completeness and the filed alphabetically with the records of other closed cases within 30 days of the patient's discharge from service. During agency staff interview on 11/29/2021 at 9:12 AM, the Administrator reported the clinicians use Chrome Books for charting and the Chrome Books are password protected. . Current hard copy charts with patient documentation in paper form are stored in locked file cabinets in the chart room. Closed records are also kept in locked file cabinets in training room. Surveyor observation on 11/29/2021 beginning at 9:55 AM revealed the following: 1. The surveyor noted 4 large boxes sitting on top of the file cabinets in the training room. The training room door handle did not have a lock on it. The boxes were labeled as follows: a. Thinned charts for Patient #19 Box 1 b. Patient #20 LPN (licensed practical nurse) notes c. Patient #21 EPSDT notes March 2019- June 2020 d. Patient #22 EPSDT notes March 2019-June 2020 2. The surveyor noted multiple manila file folders sitting on top of the file cabinets labeled as discontinued as follows: a. September 2021- Discontinued charts for Patients #30, #31, #32, #33, #34, #35 and #36. b. October 2021- Discontinued charts for Patients #14, #24, #25, #26, #27, #28, #29, #37and #38 c. One unlabeled discharge record for Patient #23. 3. The surveyor noted green file folders sitting on top of the file cabinets labeled with the following patient names: Patient #14, #34, #33, #30, #26, #27#39, #40, #41, #42, #43 and #44 All of the above stated boxes, manila folders and green folders contained visit notes from varying disciplines; Plans of Care signed by the physician; comprehensive assessments; and/or signed physician interim orders. 4. The surveyor noted another stack of mixed manila and green folders sitting on top of the file cabinets labeled as discontinued as follows: a. July 2021- Discontinued chart for Patient #48 b. August 2021- Discontinued chart for Patient #63, #64, #65, #66, #67 and #68 c. September 2021- Discontinued charts for Patients #49, #50, #51, #52, #53, #54, #55, #56, #57, #58, #59, #60, #61, #62, #69 and #70 All of the above stated manila folders and green folders contained visit notes from varying disciplines; Plans of Care signed by the physician; comprehensive assessments; and/or signed physician interim orders. 5. The surveyor noted two large boxes sitting on top of another set of file cabinets labeled as follows: a. Thinned March 2017-July 2018 for Patient #71 b. Thinned March 2017-August 2018 for Patient #21 6. The surveyor noted a mixture of manila and green folders labeled as follows: a. Unlabeled folders for Patients #72, #12, #73 and #74 b. Thinned charts dated in 2018 for Patients #21, #85, #75, #76 and #77 All of the above stated boxes, manila folders and green folders contained visit notes from varying disciplines; Plans of Care signed by the physician; comprehensive assessments; and/or signed physician interim orders. 7. The surveyor also noted the following loose documents sitting in a pile on top of the file cabinets: a. Loose hospital history and physical, dated 12/16/2020 and 12/29/2020, for Patient #78 b. Loose PT note, dated 8/10/2020, for Patient #79 c. Loose insurance information for Patient #80, #81 and #82 d. Loose signed interim physician order, dated 10/14/2020, for Patient #83 e. Loose durable power of attorney papers for Patient #84 f. Loose HHA visit notes, dated 5/25-6/22/2020, for Patient #85 g. Loose signed Plan of Care, dated 7/17/2020-9/14/2020, for Patient #86 h. Loose signed interim physician order, 10/23/2020, for Patient #87 i. Loose insurance paperwork for Patients #83 and #88 8. The surveyor noted multiple large boxes sitting on the floor in the back corner of the training room. Each box contained the following: a. Manila folders of thinned records 2018 for Patients #119, #120, #100, #103, #121, #122, #123, #124, #125, #21, #22, #23, #108, #93, #142, #143, #108, #115, #144 and #105 b. Manila folders of thinned records 2019 for Patients #89, #101, #76, #68, #102, #103, #104, #105, #106, #107, #136, #137, #138, #139, #140, #20, #100, #98, #20, #22, #75, #77, #123, #93, #108, #117, #112, #113, #121 and #90, c. Manila folders of thinned records 2020 for Patients #90, #91, #92, #93, #94, #16, #95, #23, #95, #96, #77, #97, #98, #99, #100, #85, #108, #109, #110, #11, #112, #113, #114, #115, #116, #117, #118 and #104. All of the above stated manila folders contained visit notes from varying disciplines; Plans of Care signed by the physician; comprehensive assessments; and/or signed physician interim orders. 9. The surveyor noted manila folders sitting on top of a table located in the training room labeled as follows: Discontinued charts in 2021 for Patients #126, #127, #128, #129, #130, #131, #132, #133, #134 and #135 All of the above stated manila folders contained visit notes from varying disciplines; Plans of Care signed by the physician; comprehensive assessments; and/or signed physician interim orders. 10. The surveyor noted large boxes sitting on a table in the training room labeled as follows: a. Contract cases- Patients #145, #146, #147, #148, #149, #150, #151, #152, #153, #154, #155, #156, #157, #158, #159, #160, #161, #162, #163, #164, #165, #166 and #167. All of the contract cases included patient information while being cared for by Iowa Home Care. 11. The surveyor noted a large box of thinned/discharged manila folders sitting on a table in the training room, labeled as follows: a. Thinned in 2018- Patient #168, #169 #170, #20, #71, #75, #85, #144 and #117 b. Discharged records not labeled with discharge date- #171, #172, #173, #174, #175, #176, #177, #178, #179, #180, #181, #182, #183, #184, #185, #186, #187, #188, #189, #20, #190, #191, #192, #193, #194, #195, #196, #197, #198, #199, #200, #201 and #202 All of the above stated manila folders contained visit notes from varying disciplines; Plans of Care signed by the physician; comprehensive assessments; and/or signed physician interim orders. 12. On 11/29/2021 at 10:55 AM, while the surveyor was alone in the training room, a man entered the room where the unsecured charts were stored. He carried in 4-5 bottles of water for the agency's water cooler and then left. The man did not have any identifying name badge on but appeared to wear a uniform of a vendor. 13. During agency staff interview on 11/29/2021 at 11:00 AM, the Chief of Organizational Performance reported all of the patient information being stored unsecured in the training room should be placed in the locked file cabinets so they will be secured. "I don't know if they ran out of room or what but the Administrator has told the girls to lock up the documents after you are done." 14. During agency staff interview on 11/29/2021 at 12:00 noon, the Chief of Organizational Performance reported the training room is used to train newly hired home health aides and used as a second conference room if needed. 15. The surveyor observed all charts/document mentioned above, were stored in the locked file cabinets by 3:12 PM. 16. On 11/30/2021 at 9:00 AM, the surveyor noted the training room had a new door knob with a keyed lock. The Administrator reported changing the door knob the previous evening at approximately 7:30 PM. The surveyors found all file cabinets secured and door to room was locked. 17. On 11/30/2021 at 4:45 PM, the surveyor observed a construction worker enter the office through a door in the rear of the building near the bathrooms. The door lead to a garage. In the garage, the surveyor noted a table set up as a break room for construction workers working on the garage level of the building and the upstairs church. The door leading to the garage is at the end of the hallway directly across from the training room. During agency staff interview with the Chief of Organizational Performance, the surveyor was told construction had been occurring in the building for several months. The door to the garage is left unlocked as an emergency escape route. Prior to locking up the patient information that was previously stored in an unsecure manner, the construction workers would have had potential access to the patient information when in the home health office. The above findings were reviewed with the agency Administrator and the Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey.

The Iowa Department of Inspections and Appeals conducted an investigation of complaint #98594-C on 8/2/2021 through 8/4/2021. The complaint investigation identified the following: Allegations related to 42 CFR 484.60 Care Planning, Coordination and Quality of Care were substantiated with related condition level deficiencies (G572, G590 and G606) and additional condition level deficiencies unrelated to the complaint allegations (G574, G580, G612, and G614). As a result of the agency's non-compliance with federal Conditions of Participation, the agency and its registered nurses are prohibited from providing basic home health aide skills competency training and from providing both written and demonstrated basic skills competency evaluation for all newly hired home health aides for a period of 2 years, beginning on 8/4/2021 and ending on 8/4/2023.

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, home visit observation, patient/caregiver interview and agency staff interview, the agency: 1) failed to ensure each patient received services as ordered (G572); 2) failed to ensure all supplies/equipment/medications/treatments required by the patient to meet his/her needs were included and accurate on each patient's Plan of Care (G574); 3) failed to provide medications, treatments and services only as ordered by a physician (G580); 4) failed to promptly alert the relevant physician(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or the plan of care should be altered (G590); 6) failed to assure communication/coordination of all staff involved in the patient's care (G606); 7) failed to provide agency patients with written visit schedules (G614); and 8) failed to provide agency patients with written medication schedule/instructions (G616). 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 205 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 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 for Care for 6 of 6 sampled patients (Patients #1, #2, #3, #4, #5, and #6). The agency reported a census of 205 patients at the time of the survey. 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: Interview on 8/2/2021 at 3:35 PM, Administrator reported if the plan of care cannot be followed, the agency notifies the physician. If visit frequency differs from the Plan of Care, the physician is notified of missed visits through a missed visit order that is sent the same day the visit is missed and a PRN "as needed" visit order is obtained for extra visits or interventions. Interview on 8/3/2021 at 8:19 AM, Clinical Manager reported staff document communication with the physician in care coordination notes section or by physician order. The Clinical Manager reported if the plan of care cannot be followed, the agency notifies the physician. If visit frequency differs from the Plan of Care, the physician is notified of missed visits and an order is obtained for extra visits or interventions. According to the agency policy, titled Care Planning Process and dated April 2019, clinicians will inform the patient's physician of any changes suggesting a need to alter the Plan of Care. Changes will be in writing, dated and signed by the person making the change. In the event visits are provided less than ordered, the agency will consider the reason for the missed visit and the potential/actual impact on the patient. The physician will be updated timely by the clinician if there is an actual/potential significant impact to the patient's health or medical treatment. The agency may wait until the end of the 60 day period to notify the physician if no significant impact was identified. 1. Patient #1 had a start of care date of 12/18/2020. Clinical record review revealed: a. The Plan of Care, dated 6/16/2021 to 8/14/2021, included physician orders for home health aide visits 3 times per week. b. A missed visit note, dated 7/7/21, documented the patient was not home at the time of visit and the patient wanted to wait until Friday for a visit. The note further documented the physician was not notified of the missed visit. The clinical record included documentation of only two home health aide visits during the week of 7/4/2021-7/10/2021. The clinical record lacked documentation of any contact with the patient's physician to report the missed visits either verbally or by written notification. The clinical record lacked documentation of any physician orders changing the frequency of planned home health aide visits. 2. Patient #2 had a start of care date of 2/6/2021. Clinical record review revealed: a. The Plans of Care, dated 4/7/2021 to 6/5/2021 and 6/6/21 to 8/4/21, included physician orders for the skilled nurse to set up medications in a planner every 7 days. b. The skilled nursing visit notes, dated 6/1/21 and 6/5/21, lacked documentation of medication set up the week of 5/30/21-6/5/21. c. The skilled nursing visit notes, dated 6/21/21, 6/23/21, and 6/25/21, lacked documentation of medication set up the week of 6/20/21-6/26/21. d. The skilled nursing visit notes, dated 6/28/21, 6/29/21 and 7/2/21, lacked documentation of medication set up the week of 6/27/21-7/3/21. e. The skilled nursing visit notes, dated 7/11/21, 7/15/21, and 7/16/21, lacked documentation of medication set up the week of 7/11/21-7/17/21. The clinical record lacked documentation of any contact with the patient's physician to report no medication set up either verbally or by written notification. The clinical record lacked documentation of any physician orders in regards to medication set up. 3. Patient #3 had a start of care date of 2/22/2021. Clinical record review revealed: a. The Plans of Care, dated 4/23/2021 to 6/21/202, included physician orders for the skilled nurse to perform medication set up. b. The skilled nursing visit note, dated 6/2/21, lacked documentation of medication set up the week of 5/30/21-6/5/21. The clinical record lacked documentation of any contact with the patient's physician to report no medication set up either verbally or by written notification. The clinical record lacked documentation of any physician orders in regards to medication set up. 4. Patient #4 had a start of care date of 9/14/2020. Clinical record review revealed: a. The Plan of Care, dated 3/13/21 to 5/11/2021, included physician orders for skilled nursing visits 1 time per week for assessment/observation of vital signs, medication set up, education, and monitoring medication compliance. b. The update to the comprehensive assessment for recertification, dated 3/10/21, lacked documentation of medication set up the week of 3/7/21 to 3/13/21. c. The skilled nursing visit note, dated 3/18/21, lacked documentation of medication set up the week of 3/14/21 to 3/20/21. d. The skilled nursing visit note, dated 4/22/21, lacked documentation of medication set up the week of 4/18/21 to 4/24/21. The subsequent skilled nursing visit note, dated 4/30/21, documented the patient's medications were set up for 3 weeks except Vraylar, as the patient received the Vraylar in sample packets from the psychiatrist. The nurse documented "will inform patient's caregiver so appointment can be made". The clinical record lacked documentation of the nurse notifying the sister of actual need to schedule an appointment. On 8/4/21 at 8:27 AM, interview with the primary care physician's office reported the patient received a quantity of 28 Vraylar on 2/19/21. The patient was not seen again by the provider until 5/6/21 and was to receive samples from the physician at that time, however, the patient left the waiting room before the samples could be provided. The physician's office did not have any notes of any contact from the agency, patient, or family from 2/19 through 8/4/21, other than orders sent over for signature from the agency for provider signature. On 8/4/21 at 8:34 AM, interview with pharmacy staff reported the patient first received Vraylar from the pharmacy on 5/17/21. The patient received refills of the Vrylar again on 6/15/21 and 7/13/21. Pharmacy staff further reported refills for Aripiprazole, Seroquel, and Hydroxyzine were filled as 90 day supplies on 3/10/21 and not again until 7/13/21 (leaving the patient without medications for about 1 month). The clinical record lacked documentation of what medications were called in and what date they were called in. On 8/4/21 at 9:03 AM, interview with Staff C, Registered Nurse (RN) reported the nurse did not contact the physician regarding the patient's lack of having Vraylar in the home as whenever the nurse called that particular physician's office, she would never receive any return calls from them. The nurse stated medications were ordered by the agency and delivered to the patients home by the pharmacy. All medications were kept in the patient's caregivers home that was in the same building complex as where the patient lived. f. The Plan of Care, dated 5/12/21 to 7/10/2021, included physician orders for skilled nursing visits 1 time per week and the nurse to perform medication set up if patient/caregiver are unable to safely/independently manage. The care summary narrative documented hypertension has improved since regulating his medications with nurse oversight weekly regarding compliance and taking at correct times and patient's mental health has remained stable with very good compliance with medications. g. The skilled nursing visit note, dated 5/14/21, documented medications were set up for 21 days and patient reported had Vraylar, but none was in patient's medication container. h. A journal note, dated 5/20/21, documented a phone call was placed to decrease skilled nursing visits to every 2 weeks due to medications currently being set up for 14 days and the patient was agreeable to the change. i. A physician's order, dated 5/21/21, ordered decreasing visits to 1 visit for the week of 5/12/21 to 5/20/21, and then 1 visit every 14 days, starting 5/23/21. j. The skilled nursing visit note, dated 6/22/21, documented medications were set up 5/22/21 for 21 days (through 7/13/21). k. The update to the recertification visit, dated 7/6/21, lacked documentation of medication set up. l. The Plan of Care, dated 7/11/21 to 9/8/2021, included physician orders for skilled nursing visits 1 time per week and the nurse to perform medication set up if patient/caregiver are unable to safely/independently manage. The care summary narrative documented skilled nursing to set up medications weekly, monitor compliance, and provide education as needed and the patient has been compliant with medications. m. The clinical record lacked documentation of any skilled nursing visits during the week of 7/11/2021-7/17/2021 and 7/25/21-7/31/21 n. The skilled nursing visit note, dated 7/19/21, documented medications were set up for 2 weeks. The patient did not not have medications set up by the nurse for 6 days. The clinical record lacked documentation of any contact with the patient's physician to report the missed visits and medication either verbally or by written notification. The clinical record lacked documentation of any physician orders changing the frequency of planned skilled nursing visits. The medications were not set up as ordered by the physician. 5. Patient #5 had a start of care date of 3/10/21 and a discharge date of 4/9/2021. Clinical record review revealed: a. The Plan of Care, dated 3/10/2021 to 5/8/2021, included physician orders for the skilled nurse to assess weight gain and report fasting and random blood sugars less than 60 or greater than 400. b. The skilled nursing visit notes, dated 3/12/21, 3/15/21, 3/17/21, 3/19/21, and 3/31/21, lacked documentation of assessment of the patient's weight or blood sugars. c. The skilled nursing visit notes, dated 3/25/21, 3/29/21, 4/2/21, 4/5/21, and 4/7/21, lacked documentation the patient's weight. The clinical record lacked documentation of any contact with the patient's physician to report the missed weights or blood sugars either verbally or by written notification. The clinical record lacked documentation of any physician orders in regards to weights or blood sugars. 6. Patient #6 had a start of care date of 9/25/2020 and was discharged from the agency on 5/20/2021. Clinical record review revealed: a. The Plan of Care, dated 3/24/2021 to 5/22/2021, included physician orders for home health aide 2 times per week. b. A missed visit note, dated 3/30/21, documented a home health aide missed visit. c. The clinical record included documentation of only one home health aide visit during the week of 3/28/2021-4/3/2021. The clinical record lacked documentation of any contact with the patient's physician to report the missed visit either verbally or by written notification. The clinical record lacked documentation of any physician orders changing the frequency of planned home health aide visits. The above findings for Patients #1, #2, #3, #4, #5, and #6 were reviewed with agency Administrator and Staff B, Chief of Organizational Performance. Agency staff provided no further 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 agency policy review, clinical record review, home visit observation, agency staff interview and patient or patient caregiver interview, the agency failed to ensure the accurate completion of all components comprising the Plan of Care, including all medications and supplies/equipment used by the patient for 2 of 2 sampled patients with home observation visits (Patients #1 and #2). The agency reported a current census of 205 patients at the time of the survey. 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 4/2019, the individualized plan of care includes the following: all pertinent diagnoses, the patient's mental, psychosocial and cognitive status, medications including dose, frequency, and route, the types of services, supplies and equipment required, the frequency and duration of visits to be made, prognosis, rehabilitation potential, functional limitations, activities, nutritional requirements, safety measures to protect against injury, a description of the patient's risk for emergency hospitalization and hospital readmission, discharge planning, patient-specific interventions and education and measurable outcomes and goals and information related to advance directives. 1. Patient #1 had a start of care date of 12/18/2020. Clinical record review, home visit observation and accompanying interviews revealed the following: a. The Plan of Care, dated 6/16/21 to 8/14/21, documented the following as equipment and supplies as equipment used to meet the patient's needs: cane, grab bars, hand-held shower, medication planner, pulse oximeter, urinary pad, and walker. b. During a home visit observation with Staff C, Registered Nurse (RN), the surveyor observed the nurse performing medication set up. Staff C reported the patient is very good about wearing compression stockings and usually wears the stockings until they are worn out. The patient was wearing compression stockings to bilateral lower extremities. The patient reported having stocking for "years". The surveyor observed the patient sitting in a lift chair in the living room. The patient reported having and using the chair for "5-6 years". Staff C assessed the patient's vital signs. The patient had an electronic blood pressure machine and requested Staff C compare it with the nurse's reading. The patient stated he/she has had the blood pressure machine for the past year and use of the blood pressure machine regularly. Staff C reported the patient has Ketoconazole shampoo in the bathroom, but does not have the medicated shampoo on the patient's medication list. The surveyor observed Ketoconazole 2 % shampoo on a shelf next to the patient's sink. The patient's caregiver reported the patient has had the shampoo for years and using it every other day. The Plan of Care, dated 6/16/21 to 8/14/21, lacked inclusion of the compression stockings, lift chair, blood pressure machine, Ketoconazole shampoo as supplies/medication used to meet the patient's needs. 2. Patient #2 had a start of care date of 2/6/2021. Clinical record review, home visit observation and accompanying interviews revealed the following: a. The Plan of Care, dated 6/6/21 to 8/4/21, documented the following as equipment and supplies as equipment used to meet the patient's needs: aerochamber, gait belt, grab bars, incentive spirometer, IV pole, medication planner, ramp, scale, shower chair, urinary pad, walker, and colostomy supplies. b. During a home visit observation with Staff D, Registered Nurse (RN), the surveyor observed the patient's bathroom had a hand-held shower. Interview with the patient's caregiver revealed the hand held shower has been in place before the patient was sick and prior to start of care with the agency. The caregiver revealed use of the hand held shower every time the patient takes a shower. The Plan of Care, dated 6/6/21 to 8/4/21, lacked inclusion of the hand held shower as equipment used to meet the patient's needs. The above findings for Patients #1 and #2 were reviewed with agency Administrator and Staff B, Chief of Organizational Performance. 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 agency policy review and clinical record review, the agency failed to provide treatments or services only as ordered by the physician for 1 of 3 sampled patients with orders for wound care (Patient #5 and #6). The agency reported a current patient census of 205 patients. The agency reported providing care to 28 patients with wounds at the time of the survey. 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: According to the agency policy, titled Care Planning Process, dated 4/2019, the individualized Plan of Care must include orders for patient specific home health service needs identified in the comprehensive assessment and the responsible discipline(s), treatments and procedures, including amount/frequency/duration. 1. Patient #5 had a start of care date of 3/10/21 and discharged from agency services on 4/19/21. Clinical record review revealed: a. The Plan of Care, dated 3/10/21 to 5/8/21, included orders for skilled nursing to perform wound vac dressing changes every Monday, Wednesday, and Friday to bilateral groin. b. The licensed practical nurse visit note, dated 3/25/21, documented the licensed practical nurse (LPN), visited the patient on Thursday. c. Complaint form, dated 3/29/21, documented the patient complained to the agency regarding the nurse visit on Thursday "(not his normally scheduled day)" and patient felt wound care was rushed and the dressing fell off after the nurse left and patient's caregiver had to go get more supplies and redress the dressing. The resolution of the complaint was the Administrator spoke with nurse about taking enough time to complete all cares and to assure the patient feels they are cared for and not a nuisance. The visit note lacked documentation of communication with the physician to visit the patient a day early than the ordered date for dressing change. d. The skilled nursing visit note, dated 3/29/21, documented the nurse packed up the wound vac to be sent back to the company. The visit note lacked documentation of communication with the physician to discontinue wound vac therapy. The above findings for Patients #5 and #6 were reviewed with agency Administrator and Staff B, Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on clinical record review, agency policy review, review of agency therapy contracts and agency staff interview, the agency failed to notify the physician of changes in patient condition or needs that suggest an alteration to the Plan of Care for 2 of 6 sampled patients (Patients #4, #5 and #6). The agency reported a current census of 205 patients. Failure to report changes in patient condition or identified needs placed agency patients at risk for inadequate or inappropriate care. Findings include: Interview on 8/2/2021 at 3:35 PM, with Agency Administrator reported if the plan of care cannot be followed, the agency notifies the physician. If visit frequency differs from the Plan of Care, the physician is notified of missed visits through a missed visit order that is sent the same day the visit is missed and a PRN "as needed" visit order is obtained for extra visits or interventions. Interview on 8/3/2021 at 8:19 AM, with agency Clinical Manager reported staff document communication with the physician in care coordination notes section or by physician order. The Clinical Manager reported if the plan of care cannot be followed, the agency notifies the physician. If visit frequency differs from the Plan of Care, the physician is notified of missed visits and an order is obtained for extra visits or interventions. The Clinical Manager further reported documentation of routine visits, verbal orders, and communication notes are all to be completed by midnight the same day of occurrence. According to the agency policy, titled Care Planning Process and dated April 2019, clinicians will inform the patient's physician of any changes suggesting a need to alter the Plan of Care. Changes will be in writing, dated and signed by the person making the change. In the event visits are provided less than ordered, the agency will consider the reason for the missed visit and the potential/actual impact on the patient. The physician will be updated timely by the clinician if there is an actual/potential significant impact to the patient's health or medical treatment. The agency may wait until the end of the 60 day period to notify the physician if no significant impact was identified. 1. Patient #4 had a start of care date of 9/14/2020. Clinical record review and associated interviews revealed the following: a. The Plan of Care, dated 7/11/21 to 9/8/21, documented the diagnoses of schizophrenia and bipolar disorder. The Plan of Care ordered skilled nursing services weekly. b. During patient interview on 8/4/21 at 8:42 AM, the patient reported contacting the agency on Monday 8/2/21 and informed them he/she no longer wanted services and was switching home health care to a different agency. c. Interview on 8/4/21 at 9:10 AM, Administrator reported this morning Staff F, Licensed Practical Nurse (LPN) discussed at case conference the patient was changing home health care agencies. The administrator further stated their should be a missed visit note in patient's chart, however, sometimes they wait to do the missed visit until later in the week since patient has not yet been discharged. d. Interview on 8/4/21 at 9:28 AM with Staff F, LPN reported, the patient was an addition to her schedule on Monday, 8/2/21 and a phone call was made to the patient. The patient reported he/she did not want to be seen. Since the patient is a mental health patient, the LPN planned to wait to attempt a visit again later in the week. The patient did not tell the LPN of wishes to be discharged. e. Interview on 8/4/21 at 9:32 AM, Administrator reported the patient contacted Staff G, Clinical Data Specialist, on Monday 8/21/21, to inform of request to be discharged and changing home health agencies. Staff G, Clinical Data Specialist, contacted the other agency to verify patient would be receiving services from them and sent out an email to all professional and office staff at that time. LPNs only come in to huddle on Wednesdays, so the patient's discharge was not discussed until 8/6/21. The patient's clinical record lacked documentation of the discharge request. The clinical record lacked documentation of any communication with the physician to report the requested discharge timely or any attempt to seek direction from the physician on how to proceed. f. The Plan of Care, dated 3/13/21 to 5/11/2021, included physician orders for skilled nursing visits 1 time per week for assessment/observation of vital signs, medication set up, education, and monitoring medication compliance. g. The update to the comprehensive assessment for recertification, dated 3/10/21, lacked documentation of medication set up the week of 3/7/21 to 3/13/21. h. The skilled nursing visit note, dated 3/18/21, lacked documentation of medication set up the week of 3/14/21 to 3/20/21. i. The skilled nursing visit note, dated 4/22/21, lacked documentation of medication set up the week of 4/18/21 to 4/24/21. The subsequent skilled nursing visit note, dated 4/30/21, documented the patient's medications were set up for 3 weeks except Vraylar, as the patient received the Vraylar in sample packets from the psychiatrist. The nurse documented "will inform patient's caregiver so appointment can be made". The clinical record lacked documentation of the nurse notifying the sister of actual need to schedule an appointment. The clinical record lacked documentation of any communication with the physician to report no medication set up as ordered or any attempt to seek direction from the physician on how to proceed. On 8/4/21 at 8:27 AM, interview with the primary care physician's office reported the patient received a quantity of 28 Vraylar on 2/19/21. The patient was not seen again by the provider until 5/6/21 and was to receive samples from the physician at that time, however, the patient left the waiting room before the samples could be provided. The physician's office did not have any notes of any contact from the agency, patient, or family from 2/19 through 8/4/21, other than orders sent over for signature from the agency for provider signature. On 8/4/21 at 8:34 AM, interview with pharmacy staff reported the patient first received Vraylar from the pharmacy on 5/17/21. The patient received refills of the Vrylar again on 6/15/21 and 7/13/21. Pharmacy staff further revealed refills for Aripiprazole, Seroquel, and Hydroxyzine were filled as 90 day supplies on 3/10/21 and not again until 7/13/21 (leaving the patient without medications for about 1 month). The clinical record lacked documentation of what medications were called in and what date they were called in. On 8/4/21 at 9:03 AM, interview with Staff C, Registered Nurse (RN) reported the nurse did not contact the physician regarding the patient's lack of having Vraylar in the home as whenever the nurse called that particular physician's office, she would never receive any return calls from them. The nurse stated medications were ordered by the agency and delivered to the patients home by the pharmacy. All medications were kept in the patient's caregivers home that was in the same building complex as where the patient lived. j. The Plan of Care, dated 5/12/21 to 7/10/2021, included physician orders for skilled nursing visits 1 time per week and the nurse to perform medication set up if patient/caregiver are unable to safely/independently manage. The care summary narrative documented hypertension has improved since regulating his medications with nurse oversight weekly regarding compliance and taking at correct times and patient's mental health has remained stable with very good compliance with medications. k. The skilled nursing visit note, dated 5/14/21, documented medications were set up for 21 days and patient reported had Vraylar, but none was in patient's medication container. l. A journal note, dated 5/20/21, documented a phone call was placed to decrease skilled nursing visits to every 2 weeks due to medications currently being set up for 14 days and the patient was agreeable to the change. m. A physician's order, dated 5/21/21, ordered decreasing visits to 1 visit for the week of 5/12/21 to 5/20/21, and then 1 visit every 14 days, starting 5/23/21. n. The skilled nursing visit note, dated 6/22/21, documented medications were set up 5/22/21 for 21 days (through 7/13/21). o. The update to the recertification visit, dated 7/6/21, lacked documentation of medication set up. p. The Plan of Care, dated 7/11/21 to 9/8/2021, included physician orders for skilled nursing visits 1 time per week and the nurse to perform medication set up if patient/caregiver are unable to safely/independently manage. The care summary narrative documented skilled nursing to set up medications weekly, monitor compliance, and provide education as needed and the patient has been compliant with medications. q. The clinical record lacked documentation of any skilled nursing visits during the week of 7/11/2021-7/17/2021 and 7/25/21-7/31/21 r. The skilled nursing visit note, dated 7/19/21, documented medications were set up for 2 weeks. The patient did not not have medications set up by the nurse for 6 days. The clinical record lacked documentation of any contact with the patient's physician to report the missed visits and medication either verbally or by written notification. The clinical record lacked documentation of any physician orders changing the frequency of planned skilled nursing visits. The medications were not set up as ordered by the physician. 2. Patient #5 had a start of care date of 3/10/2021 and a discharge date of 4/9/21. Clinical record review revealed the following: a. The Plan of Care, dated 3/10/2021 to 5/8/2021, ordered skilled nursing visits three times weekly to assess weight gain and report any abnormal findings to the physician. b. The initial comprehensive assessment at start of care, dated 3/10/21, documented the patient's initial weight of 176 pounds (lbs). c. The skilled nursing visit note, dated 3/22/21, documented the patient's weight at 164 lbs, a 12 pound weight loss in 12 days. The clinical record lacked documentation of communication with the physician of the patient's abnormal weight loss. d. The skilled nursing visit note, dated 3/24/21, documented the patient's weight of 170 lbs, a weight gain of 6 lbs in 2 days. The clinical The clinical record lacked documentation of communication with the physician of the patient's abnormal weight gain. 3. Patient #6 had a start of care date of 9/25/2021 and discharged from agency services on 5/20/2021. Clinical record review revealed: a. The Plan of Care, dated 3/24/21 to 5/22/21, included orders for skilled nursing to assist with dressing changes to stoma. b. The licensed practical nurse visit note, dated 5/13/21, documented skin tears to the patient's bilateral wrists. The note further stated dressings were intact and the LPN educated the patient to change the dressings daily. The visit note lacked documentation of communication with the physician regarding the presence of the new skin tears and to obtain orders for dressing changes. The above findings for Patients #4, #5, and #6 were reviewed with agency Administrator and Staff B, Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on clinical record review, agency policy review and agency staff interview, the agency failed to coordinate services provided by all disciplines in a manner to effectively meet the identified needs of the patient for 1 of 6 sampled patients receiving care (Patients #2). The agency reported a current census of 205 patients. Failure to coordinate services provided by all disciplines placed agency patients at risk for inadequate or ineffective care. Findings include: According to the agency policy, titled Care/Service Coordination and dated May 2018, each patient will be assigned a case manager upon admission and it will be the responsibility of the case manager to facilitate communication about changes in the patient's status among assigned personnel. Documentation of all communications will be included in the clinical record on a communication note, case conference summary, or clinical note. Interview with agency Clinical Manager on 8/3/21 at 8:19 AM revealed case conferences are documented in the skilled nursing visit note, care coordination notes, or journal notes. Patient #2 had a start of care date of 9/25/2020 and a discharge dated of 5/20/2021. Clinical record review revealed the following: a. The Plan of Care, 3/24/2021 to 5/22/2021, included physician orders for skilled nursing and home care aide visits. b. The physical therapy visit note, dated 3/23/21, documented discharge from physical therapy. c. The occupational therapy visit note, dated 3/23/21, documented discharge from occupational therapy. b. The skilled nursing visit note, completed by the licensed practical nurse (LPN) and dated 3/25/21, documented the patient continued to work with physical and occupational therapy. The clinical record lacked documentation of any communication between the physical therapist, registered nurse, and licensed practical nurse to discontinue therapy services on 3/23/21. The above findings were reviewed with agency Administrator and Staff B, Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits 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 and admission packet review, the agency failed to provide agency patients with written visit schedules. The agency failed to provide this information for 2 of 2 sampled patients, with a home visit observation (Patients #1 and #2) and an agency admission packet in the home. The agency reported a census of 205 patients at the time of the survey. Failure to provide the patient with a written visit schedule left the patients without the needed information to ensure the patients and patient families understood when to expect agency services. Findings include: Review of the agency's admission packet/book, titled Patient Orientation identified inclusion of the following forms: form titled Written Instructions Prepared for Patient and Caregiver with a carbon copy produced when written on with a section titled 'Your Home Care Team and Care Schedule (Ordered Disciplines and Frequency) and additional form developed by the agency with a blank monthly calendar that states the calendar will provide the patient a schedule for the next 60 days of service with the agency and after that the agency will provide the patient with their schedule with every 60 day recertification. Review of the agency's admission packet/booklet, contained an Admission Nurse Checklist. The checklist included the admitting nurse would add the disciplines, frequency and duration on the patient's calendar for the patient's home. Interview on 8/3/21 at 4:36 PM, Administrator reported admission nurse is to give the patient a schedule of visit frequency of all disciplines involved in the patient's care. 1. Patient #1 had a start of care date of 12/18/2020. On 2/19/2020 at 2:25 PM, the surveyor accompanied Staff C, Registered Nurse (RN), on a home observation visit. During the home visit, the surveyor requested review of the agency's booklet kept by the patient. During review of the folder, which included all paper work given to the patient by the agency, the surveyor found no written visit schedule, as the form in the folder was not completed. The surveyor observed no documentation including a written visit schedule posted anywhere in the patient's home. During the home visit the patient denied having a written schedule of when and which discipline was coming to visit. 2. Patient #2 had a start of care date of 2/6/21. On 2/20/2020 at 9:05 AM, the surveyor accompanied Staff D, Registered Nurse (RN), on a home observation visit. During the home visit, the surveyor requested review of the agency's booklet kept by the patient. During review of the folder, which included all paper work given to the patient by the agency, the surveyor found no written visit schedule, as the form in the folder was not completed. The surveyor observed no documentation including a written visit schedule posted anywhere in the patient's home. During the home visit the patient denied having a written schedule of when and which discipline was coming to visit. The above findings for Patients #1 and #2 were reviewed with Administrator and Staff B, Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey.

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 and admission packet review, the agency failed to provide agency patients with written medication schedule/instructions. The agency failed to provide this information for 2 of 2 sampled patients, with a home visit observation (Patients #1 and #2) and an agency admission packet in the home. The agency reported a census of 205 patients at the time of the survey. Failure to provide the patient with written medication schedule/instructions, left the patients without the needed information to ensure the patients and patient families understood what medications were prescribed and what dosages and frequency the patient was to take the medications. Findings include: Review of the agency's admission packet/book, titled Patient Orientation identified inclusion of a form titled 'Patient Medication List' with a carbon copy produced when written on. Interview on 8/3/21 at 4:36 PM, Administrator reported admission nurse is to give the patient a handwritten medication list. 1. Patient #1 had a start of care date of 12/18/2020. On 8/3/21 at 9:09 AM, the surveyor accompanied Staff C, Registered Nurse (RN), on a home observation visit. During the home visit, the surveyor requested review of the agency's folder kept by the patient. During review of the folder, which included all paper work given to the patient by the agency, the surveyor found no documentation identifying a medication schedule or instructions as the form was left blank. No additional medication list was found in the home prior to the visit, however the nurse did leave the copy used by her to fill the patient's medication planner. 2. Patient #2 had a start of care date of 2/6/21. On 8/3/21 at 11:45 AM, the surveyor accompanied Staff D, Registered Nurse (RN), on a home observation visit. During the home visit, the surveyor requested review of the agency's folder kept by the patient. During review of the folder, which included all paper work given to the patient by the agency, the surveyor found no documentation identifying a medication schedule or instructions as the form was left blank. Interview with the patient's caregiver revealed no medication schedule or instructions were provided to them by the agency, however, the caregiver accesses the patient's medication list on the primary physician's office web portal. The caregiver provided the surveyor a copy of the medication list. The above findings for Patients #1 and #2 were reviewed with agency Administrator and Staff B, Chief of Organizational Performance. Agency staff provided no further information prior to the end of the survey.