Every finding on record at Comfort 1 Hospice LLC

Upon patient record review, 5 of 12 (Patients #2, 3, 4, 5, 9) did not have evidence in the patient record that the hospice has developed an individualized written plan of care for each patient. The plan of care must reflect patient/family goals and interventions based on the problems identified in the initial, comprehensive, and updated comprehensive assessments. The plan of care must include all services necessary for the palliation and management of the terminal illness and related conditions. Patient #2: The patient is admitted with a primary diagnosis of heart disease. There is not interventions or goals included in the plan of care for cardiac. The plan of care does not include interventions or goals for use of oxygen. Patient #3: The patient is admitted for a primary diagnosis of senile degeneration of the brain. There are no interventions or goals for neuro. Patient #4: The patient is admitted with prostate cancer. There are no interventions or goals in the plan of care for cancer or GU. Patient #5: The patient is on oxygen and nebulized medication, though there is no interventions or goals for Respiratory. Patient #9: The patient is cognitively impaired and assessed as alert and oriented x 1. There is no plan of care that includes interventions or goals for cognitive impairment.

Upon patient record review, 4 of 14 (Patient #1,2,3,8) did not have evidence the plan of care must include all services necessary for the palliation and management of the terminal illness and related conditions, including equipment and supply needs. Patient #1: There were no supplies listed on the plan of care, including oxygen supplies. Patient #2: There were no supplies included on the plan of care, including oxygen supplies, wound care supplies, incontinence supplies, personal care supplies. Patient #3: There were no supplies included on the plan of care, including gloves, incontinence supplies, personal care supplies. Patient #8: There were no Foley supplies listed on plan of care.

Upon client record review, 9 of 14 (Patient #1,2,3,6,8,10,11,13,14) did not have evidence that the IDG in collaboration with the attending physician reviewed, revised and documents the individualized plan as frequently as the patient's condition requires but no less frequently then every 15 calendar days. The agency was without a Medical Social Worker for several months (2/2024 until 7/1/2024) There was no involvement in IDG from medical social work during that time.

Upon patient record review, 5 of 12 (Patients #1, 5, 6, 7, 8) did not have evidence in the patient record that hospice aide assignments and duties are: • Assigned to a specific patient by a registered nurse that is a member of the interdisciplinary group • Written patient care instructions for a hospice aide must be prepared by a Registered Nurse who is responsible for the supervision of a hospice aide as specified under paragraph (h) of 418.76 • There is evidence in the patient record that the plan of care; indicate what tasks are to be done by the Aide and the frequency of these tasks. The use of “PRN” or “per patient choice”, for any task, whether personal care or non-personal care tasks, are not acceptable Patient #1: Aide plan of care did not include frequencies of tasks to be performed. This included haircare, oral care, and peri care. Patient #5: Aide plan of care task of Oxygen precautions did not include frequency of task to be performed. Task for lotion did not state where to apply lotion. Task for clean and file nails stated 1 time weekly and prn. The aide cannot determine the need for "prn" It must be specific. If the aide is seeing the patient more than once weekly, the tasks also must delineate which visit for any tasks not to be completed each visit. Patient #6: Aide plan of care task for clean and file nails was ordered 1 time weekly and prn. The aide cannot determine the need for "prn" It must be specific. Patient #7: Aide plan of care task for clean and file nails was ordered 1 time weekly and prn. The aide cannot determine the need for "prn" It must be specific. The task for monitoring fall precautions had no frequency. Patient #8: Aide plan of care did not list a frequency for assist with dressing or for empty Foley bag. The plan of care listed "new brief" as a care plan task with no explanation or frequency.

Upon observation, there was no evidence volunteers are used in day to day administrative and/or direct patient care roles. There is no evidence of use of volunteers for day to day administrative and/or direct patient care roles in 2024.

Upon observation, there was no evidence the annual report documents the use of volunteers providing day to day administrative and/or direct patient care services in an amount that, at a minimum, equals 5 percent of the total patient care hours of all paid hospice employees and contract personnel. The agency has not met the 5% of the total patient care hours of all paid hospice employees and contract personnel for 2023 as it was 4.6%.

Upon patient client record review, 1 of 14 (Patient #2) did not have evidence that each patient record contains Physician certification and recertification of terminal illness. Patient #2: The patient chose their attending physician. The initial certification including verbal order was received from the medical director. There is no proof of an initial certification written for the attending physician.

Based on observation, record review, and interview, the agency failed to ensure the patient/representative was provided written notice of the patient's rights and responsibilities in a language and manner that the patient/representative understood for 2 of 2 home visits conducted with Spanish-only speaking patients. (#1, 2). Findings include: 1. An agency policy revised 4/2021 titled "Facilitating Communication" stated "... Written materials will be made available in the recognized major languages ... communicate with patients in a language or form they can reasonably understand ... All patient related forms ... will be available in English, and other languages as appropriate ...." 2. Home visits at entity 1 (an assisted living facility) occurred on 5/10/2022 at 9:30 AM - 11:30 AM, with patients #1 and #2 (a married couple). Both patients spoke only Spanish. Person 6 (family member and representative for both patients) was also present for these visits, who spoke both English and Spanish. Person 6 did not reside with the patients. During this time, the patients' home folder was reviewed, which contained information for both patients. All documents in the folder were written in English. When queried if she would have preferred the documents to be written in Spanish, person 1 stated "Yes ... I can read it, but some of my family cannot ....", and indicated family stopped by to see the patients on occasion and would like to be able to read the information in the folder. A phone call was received from person 6 on 5/13/2022 at 2:54 PM, who indicated she previously requested hospice to give her a "heads up" when they visited so she could go there to translate, and when she went today (5/13/2022), the aides were already there. 3. During an interview on 5/10/2022 at 3:39 PM, when queried why patient #1 and #2's home folder documents weren't written in Spanish, the administrator indicated it was because person 1 was there, she could translate, if someone was not able to read/speak English, (we) could print it in Spanish, but in their case (patient #1 & 2), person 6 could speak and read English, so she could read it to them. Informed administrator that person 6 would like the home folder documents to be written in Spanish for visiting family who couldn't read English, to which the administrator replied she knew everyone in that family, and they all read English; and the purpose of the folder was not for everyone in the whole family to see. 4. During an interview on 5/16/2022 at 2:06 PM, when queried about the provision of documents in the patient/representatives preferred language, the clinical manager indicated she never heard of an admission packet/home folder being in a different language; the administrator indicated the folder wasn't for the family, it was for the patient and the power of attorney (POA- delegated person to make health care decisions only when the patient is no longer able to), (we) wouldn't give it in 4 different languages if there were other family members who spoke different languages, and it wasn't meant for everyone. When queried if the agency had to present documents to patients and family in language they understood, the administrator indicated person 6 spoke English, so (we) don't have to.

Based on observation, record review, and interview, the agency failed to provide patients with its policies on advance directives, or Indiana Department of Health (IDOH) information for advance directives, for 2 of 2 home visits conducted (#1, 2). Findings include: 1. Home visits at entity 1 (an assisted living facility) occurred on 5/10/2022 at 9:30 AM - 11:30 AM, with patients #1 and #2 (a married couple). During this time, the patients' home folder was reviewed, which contained information for both patients. Included in the home folder was a document dated 2019, titled "Advance Directives". The document stated "... The hospice will provide its policy and procedure for advance directives for your review and file ....", and included only contact information for IDOH. 2. During an interview on 5/16/2022 at 11:46 AM, when queried where agency policies and IDOH information for advance directives was located in the patients' home folders, the administrator indicated it was in the front of the folder under the advance directives section, the IDOH POST form (physician orders for scope of treatment, a document to record a patient's wishes for extent of treatment) was the only IDOH information included in the home folders, and stated "... we don't give in-house policies ...."

Based on observation, record review, and interview, the agency failed to ensure the patient/family was involved in the development of his or her hospice plan of care for 2 of 2 home visits conducted (#1, 2), and 2 of 2 family interviews conducted without a home visit (#4, 5). Findings include: 1. An agency policy revised 2021 titled "The Plan of Care" stated "... The patient and family/caregiver will be encouraged to participate in the development of and continued updating of the plan of care ...." 2. An agency policy dated 2016, titled "Discharge", stated "... The patient and family are included in discharge planning ...." 3. Home visits at entity 1 (an assisted living facility) occurred on 5/10/2022 at 9:30 AM - 11:30 AM, with patients #1 and #2 (a married couple), and the clinical manager. Person 6 (family) was also present during this visit and indicated the folder was shared for both patients. During this time, the patients' home folder was reviewed, which failed to include current plans of care for either patient. Person 6 indicated patient #1 had an open wound on his buttocks, and she notified the clinical manager 2 weeks ago about the wound. The clinical manager indicated she didn't know anything about a wound, to which person 6 stated "... Yes, I told you about 2 weeks ago ...." Surveyor observed 2 open wounds on the patient - 1 in the gluteal cleft (butt crack), and 1 on the left upper buttock. Patient #1's clinical record failed to indicate person 6's concern about the patient's buttock wound, or interventions for wound care previously reported by person 6. 4. During an interview on 5/9/2022 at 11:16 AM with person 7 (family of patient #4), when queried if patient #4 presently received any home services, person 7 indicated patient #4 currently received home hospice services with entity 8, they were wonderful, and they offered and provided respite services. When queried if Comfort 1 hospice ever provided respite services while patient #4 was on service, person 7 stated "No." When queried if he/she ever requested respite services at Comfort 1 hospice, person 7 stated "Yes ... [and] the first year, they never even told me I could get it ...." When queried about the frequency of nursing visits, person 7 indicated she thought the nurse was supposed to come twice weekly, and no one told her the frequency decreased to once weekly. When queried if he/she was ever involved in any meetings with the agency, person 7 stated "No." When queried how he/she was informed of any changes in the care or services provided, person 7 stated "I wasn't ....", and indicated the agency made changes without his/her consent. 5. During an interview on 5/9/2022 at 11:38 AM, with person 9 (family of patient #5), when queried to describe the discharge planning process for patient #5, person 9 stated "... [person 10, a family member and patient #5's power of attorney (POA)] ... and they [comfort 1 hospice] called her on that Friday [9/10/2021] and said they were discharging her [patient #5] effectively immediately and they were coming to get all their equipment ... They came on Monday [9/13/2021] ... luckily I had another hospice already lined up or she wouldn't have had a hospital bed ... They [comfort 1 hospice] gave her no support while on hospice ... The doctor came in and said she was no longer failure to thrive due to she was gaining weight .. She was actually declining, needed thicket [a product added to fluids to thicken it for those with difficulty swallowing] ... She was in a group home [entity 11] ...." 6. During an interview on 5/12/2022 at 3:18 PM, patient #5's clinical record document titled "Discharge Summary" was reviewed, which stated "... Discharge - No Longer Appropriate ... 09/11/2021 ...." When queried how the patient was no longer appropriate for hospice services, the administrator stated, "It's because she didn't meet criteria anymore ...." When queried to describe the discharge process, the administrator stated, "I'll give you the policy for it." When queried how much discharge notice should be given, the administrator indicated from 9/10/2021 they were speaking with family about it, notice depended on the situation. When queried of the patient's discharge date, the administrator indicated it was 9/13/2021. An additional clinical record document was reviewed during this interview, dated 9/7/2021, titled "General Details" (a skilled nursing note) stated "... discussing dc [discharge] in IDG[interdisciplinary group] ...." When queried where the document indicated discharge planning was discussed patient #5's family, the administrator indicated patient 5 was a group home patient. No further information was submitted. 7. During an interview on 5/11/2022 at 12:38 PM, when queried how the agency ensured the patients/families were involved with the creation/implementation/modification of the plans of care, the administrator stated "... IDG meetings and daily stand up or stand down meetings ... when [clinical manager] communicates with families ...." When queried if all patients received a current plan of care, the administrator indicated they should get them.

Based on observation, record review, and interview, the agency failed to ensure the patient/family received information about the services covered under the hospice benefit for 2 of 2 home visits observed (#1, 2), and 1 of 1 family interview conducted when respite services was discussed (#4). Findings include: 1. An agency document titled "Services" stated, "Services which may be provided under the direction and orders of your physician include ...." The document failed to include homemaker services, respite care, continuous care, or general inpatient care (GIP). 2. Home visits at entity 1 (an assisted living facility) occurred on 5/10/2022 at 9:30 AM - 11:30 AM, with patients #1 and #2 (a married couple), and person 6 (family), who indicated the folder was shared for both patients. During this time, the patients' home folder was reviewed, which revealed a document titled "Services", which failed to include homemaker services, respite care, continuous care, GIP care. 3. During an interview on 5/9/2022 at 11:16 AM with person 7 (family of patient #4), when queried if patient #4 presently received any home services, person 7 indicated patient #4 currently received home hospice services with entity 8, they were wonderful, and they offered and provided respite services. When queried if Comfort 1 hospice ever provided respite services while patient #4 was on service, person 7 stated "No." When queried if he/she ever requested respite services at Comfort 1 hospice, person 7 stated "Yes ... [and] the first year, they never even told me I could get it ...." 4. During an interview on 5/11/2022 at 12:51 PM, surveyor asked for a list of respite patients from 6/1/2021 to present. The administrator stated, "There's no way to pull a report." When queried when the last time any patient received respite services, the administrator stated, "I know it was last year, and I know it was warm out ... maybe September [2021] ...." Upon survey exit, no further information was submitted. 5. During an interview on 5/9/2022 at 10:30 AM, when queried if the agency had any current patients who received respite, continuous care, or GIP, the administrator stated "No, not currently ....", indicated the agency did not provide GIP care, and they haven't "gone through the process". 6. During an interview on 5/11/2022 at 12:38 PM, while reviewing the required forms completed during the survey process, the administrator was queried if the agency provided homemaker services. The administrator stated "No." 7. During an interview on 5/11/2022 at1:20 PM, when queried if the agency had written contracts for the provision of GIP, the administrator stated "No ...." 8. During an interview on 5/16/2022 at 1:52 PM, when queried of the concern with the agencies failure to provide homemaker and GIP services, the clinical manager stated, " ... I've been at other hospices where they don't do GIP ... some of these hospitals it's hard to get a contract ...."

Based on observation, record review, and interview, the agency failed to ensure a system of communication was in place with other entities to ensure the agency was responsible for, and directed, coordinated, and/or supervised all care and services provided to all patients who resided in an assisted living facility (ALF) for 2 of 2 home visits observed (#1, 2), and 1 of 1 family interview conducted for a patient who resided in a group home (#5). Findings include: 1. An agency policy revised 4/2021 titled "Coordination of Care with Contracts/Agreements" stated "... To ensure the coordination of care provided by hospice and by outside providers ... Hospice will maintain professional responsibility for all services provided ... All care provided will be in accordance with the hospice plan of care and documented in the clinical record ... When services are provided by an organization other than the hospice ... the hospice ... will receive a summary of care provided by the outside organization every two (2) weeks ...." 2. An agency policy revised 4/2021 titled "The Plan of Care" stated, "plan of care will include all services necessary for ... management of terminal illness and related conditions ... care provided to the patient ... will be in accordance with the plan of care ...." 3. An agency policy revised 3/2018, titled "Drugs and Biologicals, Medical Supplies, and Durable Medical Equipment" stated "... Use ... of equipment ... Comfort 1 Hospice will ensure that the patient ... as well as the family ... and/or other caregiver(s) [such as entity 1 staff] ... receive instruction in the safe use of durable medical equipment ... patient ... will be able to demonstrate the appropriate use of durable medical equipment to the satisfaction of the hospice staff ...." 4. A home visit was conducted at entity 1 (an ALF) on 5/10/2022, from 9:30 - 11:30 AM, with patients #1 and 2 (a married couple), the clinical manager, certified nursing assistants (CNAs) 1 & 2, and person 6 (family). Observed CNAs 1 & 2 assist the patient from a sitting position to standing, with the walker placed in front of the patient. When the patient placed his hands on the handles of the walker, it caused his elbows to flex (bend) at least 30 degrees (proper fitting of a walker should be less than 30 degrees, ideally 15-20 degrees of flexion). During this time the patients' home folder was reviewed, and person 6 indicated both patients shared the same folder. The home folder failed to include current plans of care or a current medication list for either patient. After the home visits were completed, entity 1 clinical records for patients 1 and 2 were reviewed, which failed to include the agency's current plan of care or medication list. During an interview on 5/10/2022 at 3:39 PM, when the administrator was informed of the observation made during the home visit on 5/10/2022 (the walker was not fitted properly, which caused the patient's elbows to flex at least 30 degrees), the administrator stated "... Yes ... and that's on the facility [entity 1] ... If the facility is ambulating them and adjusting it, we don't know about it. That's kind of the dilemma, we're not there ...." During an interview on 5/10/2022 at 2:35 PM, when queried what the agency expected the home folder to contain, the administrator indicated it depended if the patient was in a home or an ALF, because binders were different. No other information was provided. During an interview on 5/11/2022 at 12:38 PM, when queried how the agency ensured the patients and other caregivers were involved with the creation/implementation of the plans of care, the administrator stated "IDG [interdisciplinary group] meetings ....", and indicated the patient/caregivers should get a medication list and plan of care. 5. Clinical record review for patient #1 was completed on 5/16/2022 for patient #1, start of care date 2/02/2021, for benefit election period 3/29/2022 - 5/27/2022. The clinical record failed to indicate care coordination with entity 1 occurred, and the patient's plan of care dated 3/22/2022 failed to indicate what services entity 1 provided to the patient. 6. Clinical record review for patient #2 was completed on 5/16/2022, start of care date 8/24/2021, for election period 4/21/2022 - 6/19/2022. The clinical record failed to indicate care coordination with entity 1 occurred, and the patient's plan of care dated 4/20/2022 failed to indicate what services entity 1 provided to the patient. 7. Clinical record review for patient #5 was completed on 5/16/2022, start of care date 9/12//2021, for election period 7/14/2021 - 9/11/2021, and discharge date 9/13/2021. A skilled nursing note dated 9/7/2021 indicated the IDG was discussing discharging the patient. When queried where the clinical record indicated the discharge planning was discussed with family or entity 11 (a group home), the administrator indicated the patient was a group home patient, and no further information was provided. An IDG meeting document dated 9/01/2021 indicated the patient resided in a group home, and failed to indicate discharge planning was discussed, or what services entity 11 provided. An IDG meeting document dated 9/08/2021 indicated discharge planning was discussed for the patient's failure to decline, but failed to indicate coordination with family or entity 11 occurred. An IDG meeting document dated 9/15/2021 stated "... Pt [patient] discharged for failure to decline no longer terminally ill on 9/13/21 ... Group home staff reported improvement in pt ...." During an interview on 5/12/2022 at 3:18 PM, when queried if the group home staff included registered nurses, the administrator indicated there was not, as group homes weren't licensed facilities. When queried if it was agency policy to accept report on a patient's health status from a non-licensed person, the administrator provided no response. During an interview on 5/16/2022 at 12:08 PM, when queried what services the group home staff provided, the administrator indicated it depended on the facility, the facility was the primary, and she I couldn't speak about what they did. A document dated 7/14/2021 titled "Plan of Care" indicated entity 11 staff (not licensed nurses) identified a skin tear to the patient's left 4th finger, and was cleansed and covered with a bandage by entity 11 staff. When queried if agency staff assessed the skin tear or obtained treatment orders, the administrator indicted an aide reported the skin tear, and she wouldn't have assessed it. When queried if the aide notified anyone at the agency, the administrator stated "I can't answer that." When queried if anyone from the agency assessed the skin tear, the clinical manager indicated she didn't see an assessment in the clinical record, and she didn't see a treatment order. During an interview on 5/09/2022 at 11:38 AM, when queried to describe the discharge planning and process of the patient, person 9 (family) indicated the agency called the patient's power of attorney (POA), person 10 (also family), on 9/10/2021 and said they were discharging her effective immediately, they were coming to get all their equipment, they came on Monday (9/13/2021), and luckily family already had another hospice lined up or she wouldn't have had a hospital bed, they gave her no support while on hospice, the doctor came in and said she was no longer failure to thrive due gaining weight, but she was actually declining.

Based on record review and interview, the agency failed to ensure it provided the hospice required non-core homemaker services to meet the needs of any agency patients (See L602). This practice had the potential to affect all agency patients. The cumulative effect of this systemic problem resulted in the agency being out of compliance with the Condition of Participation 42 CFR §418.70: Furnishing of Non-Core Services.

Based on record review and interview, the agency failed to ensure it provided the required hospice non-core homemaker services to meet the needs of any agency patients. Findings include: 1. An agency document titled "Services" stated, "Services which may be provided under the direction and orders of your physician include ...." The document failed to include homemaker services was offered by the agency. 2. During an interview on 5/11/2022 at 12:38 PM, while reviewing the required forms completed during the survey process, the administrator was queried if the agency provided homemaker services. The administrator stated "No."

Based on observation, record review, and interview, the registered nurse failed to ensure the hospice aide provided only services as ordered on the plan of care/aide care plan, and were consistent with the hospice aide training, for 1 of 1 home visits observed when the aide(s) provided care (#1). Findings include: A home visits at entity 1 (an assisted living facility) occurred on 5/10/2022 at 9:30 AM - 11:30 AM, with patient #1, person 6 (family), hospice aides/certified nursing assistants (CNAs) 1 & 2, and the clinical manager. At 10:04 AM, during personal care for patient #1, CNA 2 attempted to apply a gait belt (a belt applied to a person to assist with safe transfers/ambulation) to the patient. Surveyor observed and pointed out incorrect application of the gait belt. During this time, the clinical manager demonstrated how to correctly apply and secure the gait belt. The clinical manager failed to ensure the CNAs had training for competency on use of a gait belt prior to use on a patient. Clinical record review for patient #1 was completed on 5/16/2022 for patient #1, start of care date 2/02/2021, for benefit election period 3/29/2022 - 5/27/2022. A document dated 3/23/2022 titled "Plan of Care Effective 3/23/22" failed to indicate the hospice aide was ordered to utilize a gait belt on the patient. A document dated 5/10/2022 titled "General Details" indicated the encounter/document was a hospice aide visit, the patient required maximum assistance for transfers/ambulation, but failed to include orders for the use of a gait belt, and failed to document a gait belt was used during the visit (with surveyor present). During an interview on 5/16/2022 at 1:13 PM, when queried where the clinical record indicated the use of a gait belt was ordered for use on the patient, the clinical manager indicated they (CNAs 1 & 2) had not used the gait belt before (the visit on 5/10/2022), and she thought they were "just trying it out". When queried if the use of the gait belt was on the plan of care, the clinical manager indicated it was not, and there was no order for its use. During this time, the administrator asked the clinical manager if the gait belt got ordered, to which the clinical manager failed to respond. When queried why the CNAs would take it upon themselves to "try new things" without calling the registered nurse prior to providing unordered care/services, the administrator stated "... well it's a safety issue ... they shouldn't take the time to call if it's a safety issue ... What's the issue? [with the gait belt] ....", to which the clinical manager responded "She [CNA 2] had it [gait belt] on wrong ...."

Based on record review and interview, the agency failed to ensure the patient's clinical record included the patient's desired/current advance directives for 3 of 3 active records reviewed (#1, 2, 6). Findings include: 1. An agency policy revised 4/2021 titled "Advance Directives" stated "DNR (do not resuscitate) ... [is] A medical order ... will be placed in the clinical/service record ... All clinicians ... providing care/service ... will ... Review the Advance Directive and report any discrepancies ... to the attending physician ... Assist to develop an Advance Directive ... Executing and implementing an Advance Directive is a process, not a one (1)-time event ...." 2. Clinical record review for patient #1 was completed on 5/16/2022, start of care date 2/02/2021, for election period 3/29/2022 - 5/27/2022. An admission document dated 2/02/2021, titled "Advance Directive Acknowledgment" indicated the patient did not have advance directives in place, and "911" should be called for life-threatening emergencies. A document received from entity 1 (an assisted living facility) for patient #1, dated 3/21/2022 titled "Physician's Orders" evidenced a section to record the patient's advance directives as either a full code (perform CPR), or DNR. Neither box was checked. A home visit was conducted on 5/10/2022 from 9:30 - 11:30 AM. with patients #1 & 2. At 11:20 AM, when queried about the code status (advance directives) for patients #1, person 6 (family) indicated patient #1 was a DNR. When queried if the agency provided her with copies of the patient's advance directives, she indicated they did not, and she would like a copy. During an interview on 5/10/2022 at 3:39 PM, when queried about patient #1's code status, the administrator indicated the agency documented the patient as a "full code". When the administrator was informed the family indicated the patient was a DNR, she stated, "Well she never voiced that to us ...." The agency failed to ensure the clinical record contained the patient's current advance directive wishes, and failed to ensure entity 1 had the patient's current advance directives. 3. Clinical record review for patient #2 was completed on 5/16/2022, start of care date 8/24/2021, for election period 4/21/2022 - 6/19/2022. A document received from entity 1 (an assisted living facility) for patient #2, dated 3/31/2022 titled "Physician's Orders" evidenced the patient was a DNR. An agency document titled "Plan of Care Effective 4/20/22", included a section titled "Nursing Summary Dated: 2022-04-19". This section indicated the patient was a "full code". A home visit was conducted on 5/10/2022 from 9:30 - 11:30 AM. with patients #1 & 2. At 11:20 AM, when queried about the code status (advance directives) for patients #2, person 6 indicated patient #2 wanted "some CPR", and indicated if it was "fruitless" to stop. When queried if the agency provided her with copies of the patient's advance directives, she indicated they did not, and she would like a copy. The agency failed to ensure the clinical record included the patient's chosen advance directives. 4. Clinical record review for patient #6 was completed on 5/16/2022, start of care date 6/1/2020, for benefit election period 3/23/2022 - 5/21/2022. An admission document dated 6/01/2020, titled "Advance Directive Acknowledgment" indicated the patient executed a living will (a written statement detailing a person's desires regarding their medical treatment in circumstances in which they are no longer able to express informed consent, especially an advance directive), a durable power of attorney (the named individual{or "attorney-in-fact} is granted the ability to make decisions related to care, treatment, and whether to continue life support), and wished to be a DNR. The clinical record failed to include any of these documents. During an interview on 5/16/2022 at 12:49 PM, when queried as to the patient's code status, the clinical manager indicated the patient was a DNR. Upon request to submit a copy of the DNR for review, the clinical manager indicated she didn't see a copy in the EMR (electronic medical record). During this time, the administer referred to the agency document titled "Advance Directive Acknowledgment". The agency failed to ensure the clinical record included the living will, power of attorney, or a valid DNR documented on the state of Indiana's out of hospital do not resuscitate order. When queried if the agency used the Indiana out of hospital DNR form, the administrator indicated they did, but it was not present in this record (patient #6). 5. During an interview on 5/10/2022 at 2:35 PM, when queried the agency's process for establishing advance directives, the administrator indicated there would be conversation with patient/family, explain the options, ask their wishes, make sure they have a clear understanding, the family checks all the boxes, they sign, and then the doctor signs. She also stated "... We keep a copy, and the facility gets a copy [of the advance directives]. If they're in a home, the patient gets a copy ...." When queried when agency staff discusses advance directive wishes with patients/families, the administrator indicated it was discussed during recertification visits, when family brings it up, a change in level of care, or if they went into the hospital.

Based on observation, record review, and interview, the agency failed to ensure the patient's expired/outdated medications were removed/discarded to prevent usage of expired/outdated medications for 1 of 2 home visits observed (#1). Findings include: An agency policy dated 2016 titled "Medication-Administration" stated "... Staff will check medicine container for ... expiration date ...." Clinical record review for patient #1 was completed on 5/16/2022, start of care date 2/02/2021, for election period 3/29/2022 - 5/27/2022. A home visit was conducted at entity 1 (an assisted living facility) on 5/10/2022 from 9:30 - 11:30 AM. During this visit, person 6 (family) unlocked a cabinet which revealed several medications the patient was prescribed by the hospice agency. Upon review of the medications, (3) plastic bags which contained bisacodyl (a stool softener) expired 12/2021, a box which contained atropine (a liquid to suppress oral secretions) expired 01/2022, and an unopened tube of lidocaine (topical pain relief) dated 9/30/2021, was to be applied to the left shoulder twice daily. All other medications observed were dated as filled on or before 10/21/2021. During an interview on 5/11/2022 at 2:25 PM, when queried how the patients' medications were securely stored at entity 1, person 1 (regional director of nursing at entity 1) indicated (they) did not have locked cabinets in residents' rooms since 10/01/2021, and indicated they used medication carts. During an interview on 5/11/2022 at 3:03 PM, when queried about the medications locked in the patient's cupboard, the clinical manager indicated medications were locked in the patient's room, and she didn't have a key. During an interview on 5/13/2022 at 2:54 PM, when queried about the key for the locked cabinet in the patient's room, person 6 indicated the nurse at entity 1 should have a key, she didn't see them getting medications out of the cupboard, entity 1's staff brought medications into the room for administration, and a staff member (unknown) from entity 1 gave her a key.

Based on observation, record review, and interview, the agency failed to ensure proper disposal of controlled drugs occurred in the patient's home (place of residence) for 1 of 1 home visits observed with a patient who resided at an assisted living facility (ALF), and was prescribed a controlled substance by the hospice agency (#1); and failed to have written policies and procedures for the management and disposal of controlled drugs for patients who resided at an ALF (the patient's home setting). Findings include: An agency policy revised 3/2018, titled "Medication-Controlled Substance/Drug Safety and Disposal" stated "... Long Term Care Facility (LTCF) is defined ... and ... means a nursing home, retirement care ... or other facility or institution which provides extended health care to resident patients ... A [LTCF] ... may dispose of ... controlled substances [drugs] ... Counts of controlled substances on hand each visit ...." The policy failed to include the agency's procedure for management and disposal of controlled drugs for patients who resided at ALFs. An agency policy revised 4/2021 titled "Coordination of Care with Contracts/Agreements" stated "... Core services including ... nursing ... are provided directly by the hospice ... Other services may be provided under written agreement ... Hospice program will have written agreements to provide ... routine hospice home care for patients in facilities ...." The policy failed to include the agency's procedure for management and disposal of controlled drugs for patients who resided at ALFs. A home visit was conducted at entity 1 (an ALF) on 5/10/2022, from 9:30 - 11:30 AM, with patient #1, the clinical manager, and person 6 (family). During this time, person 6 unlocked a cabinet which contained the patient's medications. Person 6 indicated this was not all of the patient's medications, as the ALF staff brought medications into the room for administration from an unknown location outside the patient's room. The cabinet failed to reveal the presence of morphine sulfate (a controlled substance for pain relief). During an interview on 5/10/2022 at 2:03 PM, patient #1's EMR (electronic medical record), was reviewed, which indicated the patient resided at entity 1, and the patient's prescribed morphine sulfate was discontinued on 11/23/2021. When queried how the agency ensured the medication was disposed of properly, the administrator stated, "I was not the one who did that, so I'd have to look." No additioonal information was submitted. During an interview on 5/11/2022 at 12:53 PM, when queried how the agency tracked administration and waste of controlled substances for patient #1, the administrator indicated the meds were managed by the ALF, the hospice agency didn't have access to the medications, the ALF should do that, the ALF should have 2 people (for disposal), and have it in the record. During an interview on 5/11/2022 at 1:03 PM with the surveyor, administrator, and person 3 (interim executive director of entity 1), person 3 queried who was responsible to ensure the proper disposal of controlled substances, to which the administrator replied (to person 3) "You." During this time, person 3 indicated facility 1 did have possession of the morphine sulfate on 11/23/2021, and indicated the current disposition of the morphine sulfate was unknown. During an interview on 5/11/2022 at 2:54 PM, when queried the location of the morphine sulfate after 11/27/2021 (when it was accounted for at the ALF), person 2 (regional director of nursing for entity 1) indicated it would have been given back to the hospice, outside providers destroy their own medications, and she did not know if the outcome of the morphine disposal. During an interview on 5/11/2022 at 3:03 PM, when queried about locked medications in the patient's room, the clinical manager indicated medications were locked in the patient's room, and she didn't have a key. During an interview on 5/12/2022 at 11:54 AM, when queried about other ALF patients who no longer used morphine, the administrator and clinical manager both indicated they don't have anything to do with the disposition of controlled substances in ALFs.

Based on observation, record review, and interview, the agency failed to ensure the patient's durable medical equipment (DME) was adjusted properly, and used safely during ambulation for 1 of 1 home visits observed for a patient who used a walker (#1). Findings include: An agency policy revised 3/2018, titled "Drugs and Biologicals, Medical Supplies, and Durable Medical Equipment" stated "... Use ... of equipment ... Comfort 1 Hospice will ensure that the patient ... as well as the family ... and/or other caregiver(s) [such as entity 1 staff] ... receive instruction in the safe use of durable medical equipment ... patient ... will be able to demonstrate the appropriate use of durable medical equipment to the satisfaction of the hospice staff ...." A home visit was conducted with patient #1 at entity 1 (an assisted living facility) on 5/10/2022, from 9:30 - 11:30 AM, with the clinical manager, certified nursing assistants (CNAs) 1 & 2, and person 6 (family) also present. Observed CNAs 1 & 2 assist the patient from a sitting position to standing, with the walker placed in front of the patient. When the patient placed his hands on the handles of the walker, it caused his elbows to flex (bend) at least 30 degrees (proper fitting of a walker should be less than 30 degrees, ideally 15-20 degrees of flexion). During an interview on 5/10/2022 at 3:39 PM, when queried who provided the patient's walker, the administrator indicated the agency provided it, and it was ordered from entity 12 (a DME company). When queried who ensured the walker was properly fitted/adjusted to the patient for safe use, the administrator indicated entity 12 did. When the administrator was informed of the observation made during the home visit on 5/10/2022 (the walker was not fitted properly, which caused the patient's elbows to flex at least 30 degrees), the administrator stated "... Yes ... and that's on the facility [entity 1] ... If the facility is ambulating them and adjusting it, we don't know about it. That's kind of the dilemma, we're not there ...."

Based on record review and interview, by the agency's own admission, it failed to ensure short term inpatient care was available/provided to the agency's patients (See L705). This practice had the potential to affect all agency patients. Findings include: The cumulative effect of this systemic problem resulted in the hospice agency's non-compliance for the Condition of Participation 42 CFR §418.108 Condition of participation: Short-Term Inpatient Care.

Based on record review and interview, by the agency's own admission, it failed to ensure short term inpatient care was available to all agency patients. Findings include: An agency document dated 2019, titled "Hospice Overview" stated "... Hospice provides for inpatient services ...." During an interview on 5/9/2022 at 10:30 AM, when queried if the agency had any current patients who received respite, continuous care, or general inpatient care (GIP), the administrator stated "No, not currently ...."; and indicated the agency did not provide GIP care, and they haven't "gone through the process". During an interview on 5/11/2022 at1:20 PM, when queried if the agency had written contracts for the provision of GIP, the administrator stated "No ...." During an interview on 5/16/2022 at 1:52 PM, when queried of the concern with the agencies failure to provide homemaker and GIP services, the clinical manager stated, " ... I've been at other hospices where they don't do GIP ... some of these hospitals it's hard to get a contract ...." During an interview on 5/9/2022 at 11:16 AM with person 7 (family of patient #4), when queried if patient #4 presently received any home services, person 7 indicated patient #4 currently received home hospice services with entity 8, they were wonderful, and they offered and provided respite services. When queried if Comfort 1 hospice ever provided respite services while patient #4 was on service, person 7 stated "No." When queried if he/she ever requested respite services at Comfort 1 hospice, person 7 stated "Yes ... [and] the first year, they never even told me I could get it ...."

Based on record review and interview, per its own policy, the agency failed to ensure had written agreements with all facilities at which agency patients resided. Findings include: An agency policy revised 04/2021 titled "Coordination of Care with Contracts/Agreements" stated "... Hospice will maintain professional responsibility for all services provided ... Hospice program will have written agreements to provide ... routine hospice home care for patients in facilities ...." During an interview on 5/12/2022 at 3:40 PM, when queried to clarify where each active patient resided, the administrator indicated 12 patients (57% of the agency's active patients) resided in assisted living facilities (ALFs), 1 patient resided at a skilled nursing facility (SNF), 3 resided at group homes, and 5 resided at private homes. During an interview on 5/11/2022 at 12:53 PM, when queried if the agency had written agreements with assisted living facilities (ALFs), the administrator indicated (we) don't, and (we) don't need one because that's like them living in their own home.

Upon observation, there was no evidence that the hospice had conducted exercises to test the emergency plan at least annually. The hospice must do the following: i. Participate in a full-scale exercise that is community-based every two years or A. When a community-based exercise is not accessible, conduct an individual facility-based functional every two years, or B. If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next full-scale community-based or individual facility-based functional exercise following the onset of emergency event ii. Conduct an additional exercise every two years, opposite the year the full-scale or functional exercise under 42 CFR 418.113(d)(2)(i) is conducted that may include, but is not limited to the following: A. A second full-scale exercise that is community-based facility-based functional exercise; or B. A mock disaster drill; or C. A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan The Administrator was unable to provide evidence that the Hospice had conducted a full scale drill in 2020 or that the emergency plan had been activated in 2020.

Upon clinical record review, 2 of 11 (Patients #5 and 6) did not contain documented evidence patients received, both orally and in writing, of the charges for care, at or prior to the receipt of services, to include any expected reimbursement from third-party payors, and any out-of-pocket responsibility by the patient, if any. Patients #5 and #6: These clinical records contained a document which stated: ..."I understand that I will be charged for all services provided at the following rates, but if the bill causes financial hardship, now or at any time in the future, I may call a billing representative of the agency to arrange a payment schedule. Comfort 1 will attain financial assessment for any private pay patient to ascertain affordability for care. Routine Home Care - $145 Per day. General Inpatient-$735 Per Day, Respite Care-$175 Per Day and Continuous Care -$940 Per Day." There was no other patient signed financial document, which clearly identified the payment of services by any third party payor or out of pocket responsibility if any.

Upon patient record review 1 of 11 (Patient #6) did not have evidence in the patient record that the hospice interdisciplinary group, in consultation with the individual's attending physician (if any), completed the comprehensive assessment no later than 5 calendar days after the election of hospice care. Patient #6 had a start of care date of 9/2/2021. The Spiritual assessment was not conducted until 9/21/2021.

Upon patient record review, 1 of 11 (Patient #3) did not contain a current/comprehensive Medication Profile. Patient #3: During a Surveyor attended home visit, it was determined the patient was no longer taking Hydroxyzine. The medication had been discontinued at the facility several months ago but was still active on the hospice medication profile.

Upon patient record review, 2 of 11 (Patients #5, 6) did not have evidence in the patient record that the comprehensive assessment included a bereavement component which includes the needs of the patient's family and other individuals focusing on the social, spiritual, and cultural factors that may impact their ability to cope with the patient's death. Patient 5: start of care date of 2/05/2021. There was no Initial Bereavement assessment as of 11/2/2021. Patient 6: start of care date of 9/2/2021. The Initial Bereavement assessment was not conducted until 10/14/2021.

Upon client record review, 1 of 11 (Patient #3) did not have evidence that the IDG had ensured that the care and services were provided in accordance with the plan of care. On the Plan of Care, the Physician ordered Volunteer services 1 x week. There was no volunteer visit made for the weeks of 10/10/2021 and 10/17/2021.

Upon personnel record review, 1 of 1 applicable aide (Personnel #8) did not have evidence of an initial aide skills competency assessment having been conducted to include all CMS required tasks. A skills competency was conducted between 6/21/2021 and 6/25/2021. However, the following skills were not evaluated for competency: • Maintenance of a clean, safe, and healthy environment • The physical, emotional, and developmental needs of and ways to work with the populations served by the hospice, including the need for respect for the patient, his or her privacy and his or her property

Upon patient record review, 4 of 9 applicable (Patients #2, 4, 7, 9) did not have evidence that the Aide Care Plan included individualized patient precautions as needed to provide safe care: Patient #2: Oxygen precautions were not listed on the Aide Care Plan. Patient #4: On the Certification dated 11/24/20 the Physician documented patient had two falls in prior months and is a fall risk and on the Certification dated 9/20/2021 the Physician documented patient has episodes of choking at times when eating and drinking but for now the daughter does not want to add thickener. The Aide care plan was not updated with Fall and Aspiration Precautions. Patient #7: On the Initial Comprehensive Assessment, the RN documented Patient has increased dysphagia due to poor condition of own teeth making it difficult to chew food. There was no aspiration precautions listed on the Aide Care Plan. Patient #9: On the Initial Comprehensive Assessment, the RN documented Left knee replacement, right great toe with partial amputation, and the patient's family was interested in Physical Therapy for strengthening his legs. There was no fall risk precaution listed on the Aide Care Plan.

Upon patient record review 5 of 9 applicable (Patients #1, 2, 3, 4, 6) did not have documented evidence that the hospice aide provided services that were ordered by the IDG and included in the plan of care. Patient #1: The Aide Plan of Care included oral care for the patient. There was no oral care provided on 10/12/21, 10/22/21, and 10/26/21. Patient #2: The Aide Plan of Care, included oral care for the patient. There was no oral care provided on 10/22/21. Patient #3: The Aide Plan of Care, included oral care for the patient. There was no oral care provided on 10/22/21. Patient #4: The Aide Plan of Care, included shower and peri care for the patient. There was no shower or peri care provided on 9/22/21. Patient #6: The Aide Plan of Care, included oral care, shower, shave, foot care and nail care for the patient. 1.There was no foot care, shower or shaving provided on 10/5/21. 2. There was no oral care, nail care, foot care and shave provided on 10/27/2021.

Upon observation, there was no evidence the annual report documents the use of volunteers providing day to day administrative and/or direct patient care services in an amount that, at a minimum, equals 5 percent of the total patient care hours of all paid hospice employees and contract personnel. Agency unable to demonstrate if there were any volunteer hours in 2019 or 2020.

Upon personnel record review, 2 of 9 applicable (Personnel #2, 7) did not have evidence that an initial skills competency assessment, specific to each discipline, had been conducted for all personnel during orientation: Personnel #2: DOH 8/17/2021. There was no skills competency in the file. Personnel #7: DOH 8/3/2020. This MSW/Bereavement Coordinator, had no skills competency for either position, in the file.

Upon Patient record review, 1 of 1 applicable (Patient #9) did not have evidence that the hospice had forwarded a Transfer Summary to the receiving Hospice upon transfer. Patient transferred to another Hospice on 10/5/2021.

Upon client record review, 1 of 1 applicable (Patient #8) did not have evidence that the completed Discharge Summary included all CMS-required information, to include the following: • A summary of the patient's stay, including treatments, symptoms and pain management • The patient's current plan of care • The patient's latest physician orders

Upon Patient record review, 11 of 11 (Patients #1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11) did not contain documented evidence of the Hospice having discussed, and then documented in the patient's record, that the written policies and procedures for managing controlled drugs had been provided and discussed.

Upon inpatient contract review, 1 of 1 applicable (Southfield Village) did not have evidence that the inpatient provider had established patient care policies consistent with those of the hospice, and agrees to abide by the palliative care protocols and plan of care established by the hospice for its patients.

Upon SNF/NF contract review, 1 of 1 (Southfield Village) did not have a delineation of the responsibilities of the hospice to provide bereavement services to SNF/NF personnel.