Every finding on record at Servant's Heart Home Health Services Inc

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the comprehensive assessment included the patient’s current health status for all diagnoses and conditions for 2 of 6 records reviewed (Patient #16, #17). Findings include: 1. Agency policy #C-145, titled “Comprehensive Client Assessment,” indicated but was not limited to “… Purpose: … To collect data about the client’s health history (physical, functional and psychological) and their needs as appropriate to the home care setting … To identify clients medical, nursing … needs … Special Instructions … 3. In addition to general health status/system assessment, the agency comprehensive assessment tool … will include: … e. Supportive assistance. f. Elimination status … l. Equipment management ….” 2. A home visit observation was conducted on 12/28/2022 at 10:23 AM with Patient #16 and the Clinical Manager. During the visit, a dialysis access site was observed to the patient’s anterior left lower arm. Patient #16 confirmed this site was a dialysis graft (surgically placed connection between an artery and vein used to perform hemodialysis) and they had no other dialysis access sites. The patient also reported they did make some urination but had noticed the amount had decreased since starting dialysis. Non-pitting edema (swelling which does not cause indentation in the skin) was observed to the patient’s lower legs. The clinical record of Patient #16 included a plan of care for the recertification period of 11/11/2022 – 01/09/2023 which indicated patient diagnoses included but was not limited to Stage 4 chronic kidney disease. The plan of care indicated Fall Precautions were enacted by the agency for Patient #16. The record included a comprehensive assessment completed on 11/07/2022 by the Clinical Manager. The assessment indicated Patient #16’s edema (swelling) had “decreased” since starting dialysis but failed to evidence the presence or absence of edema at the time of the assessment. The assessment also failed to evidence an assessment of the patient’s dialysis graft (presence or absence of thrill, bruit, bleeding, and signs and symptoms of infection), failed to evidence as assessment of the patient’s current urinary status, and failed to evidence a completed Fall Risk assessment. 4. During an interview conducted on 12/29/22 starting at 1:18 PM, the Administrator confirmed the comprehensive assessment should indicate the patient’s current health status. 410 IAC 17-14-1(a)(1)(B) The clinical record of Patient #17 included a plan of care for the certification period of 12/19/2022 – 02/16/2023. The record included an initial comprehensive assessment completed on 12/19/2022 by the Alternate CM (Clinical Manager.) The assessment indicated Patient #17 had a diagnosis of atrial fibrillation (an irregular and often rapid heart rhythm that can lead to blood clots in the heart). The assessment failed to evidence the Alternate CM assessed the patient’s heart tones. The initial comprehensive assessment also failed to evidence a depression screening for Patient #17 who had depression risk factors of, including but not limited to, chronic illness and chronic pain. During an interview on 12/29/2022 at 01:18PM, the Alternate CM indicated a patient’s heart tones should be assessed during a comprehensive assessment and that heart tones were not assessed during Patient #17’s comprehensive assessment. During the same interview, the Administrator indicated a depression screening should be completed in full during every comprehensive assessment. Neither the Administrator nor the Alternate CM evidenced a depression screening was completed for Patient #17 during their comprehensive assessment.

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 observation, record review, and interview, the home health agency failed to follow their own policies and failed ensure coordination of care to meet the patient's needs for 2 of 6 patient records reviewed (Patient #16, 17.) 3. A home visit observation was conducted on 12/28/2022 at 10:23 AM with Patient #16 and the Clinical Manager. During the visit, the nurse was observed removing an old dressing on the patient’s posterior left upper leg. The Clinical Manager reported the portion of the dressing within the inner thigh was hard to remove due to it sticking to the patient’s wound. The nurse failed to wet the dressing prior to removing it. Patient #16 reported increased pain during the procedure and a trickle of blood was observed from the area which the dressing had been difficult to remove. During an interview conducted on 12/28/2022 at 11:04 AM with the Clinical Manger, the nurse confirmed they did not wet the dressing prior to removing it, despite a portion of the dressing being stuck to the patient’s wound. The Clinical Manager reported the reason for not wetting the dressing prior to removing it was they were low on supply of wound cleanser. The Clinical Manager stated Patient #16’s dressing frequently adhered to the wound and when they performed the dressing changes the nurse would “sometimes” wet the old dressing prior to removing it, however doing this did not always prevent increased pain or bleeding. During an interview conducted on 12/28/2022 starting at 4:49 PM, the Administrator confirmed it was best practice to wet a dressing which had adhered to a wound prior to removing the old dressing. The Administrator also reported the nurse should report to the patient’s physician if there was a recurrent problems with the dressing sticking to the patient’s wound and causing pain and/or injury when removing. The Clinical Manager confirmed they had not spoken with the Patient #16’s ordering provider regarding the issue of the dressing sticking to the patient. Findings include: 1. Policy C-360 titled “Coordination of Patient Services” indicated “… Purpose… to ensure appropriate, quality care is being provided to clients… to establish effective interchange reporting, and coordination of patient care does occur… to identify needs to modify the plan of care… to evaluate the adequacy of treatment and the effect of services provided… care conferences will be held as necessary, but at a minimum every 60 days for each client… care conferences will be documented on the Care Conference Summary or in the progress notes…” 2. Policy C-680 titled “Clinical Documentation” indicated but not limited to “… missed visits: services not provided and the reason for the missed visits will be documented and reported to the physician…” 4. Record review for Patient #17 included a plan of care for certification period 12/19/2022 – 02/16/2022 with orders for HHA (Home Health Aide) services to be provided 4 hours per day, 5 days per week, for 9 weeks to assist with personal care, hygiene, and safety needs. The record indicated a missed HHA visit note for 12/23/2022, signed by the Administrator, with the reason “Cancellation of Care.” The record also indicated HHA visits on 12/19/2022, 12/26/2022, 12/27/2022, and 12/28/2022 with a duration of less than 4 hours. The record failed to indicate the HHA notified the nurse or the scheduler of the shortened visits. The record failed to evidence the physician had been notified of the shortened visits. During an interview on 12/29/2022 at 01:18PM, the Administrator indicated physicians are not called regarding missed visits, the missed visit note is faxed to the physician. During the same interview, the Alternate CM (Clinical Manager) confirmed if a patient has orders for HHA services for 4 hours per day, the patient should receive 4 hours of services. The Alternate CM indicated they were not aware of the visits with a duration of less than 4 hours and indicated no supervisory visit had been done yet as it was not yet due. The Scheduler indicated the HHA had not contacted the office regarding the abbreviated visits. The Administrator indicated the HHA should contact the nurse regarding any change, concern, complaint, or question. When asked who was responsible for reviewing aide visit notes, the Administrator indicated it was the responsibility of everyone in management and there was no policy on the frequency of aide visit notes review. 410 IAC 17-14-1(a)(1)(F), 410 IAC 17-12-2(g)

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure all staff followed infection prevention policies and procedures for 1 of 3 observations of a home visit (Clinical Manager). Findings include: An agency policy #D-330, titled “Handwashing/Hand Hygiene,” indicated but was not limited to “… Special Instructions … 7. When washing hands with soap and water … apply an amount of product recommended by manufacturer to hands and rub hands together vigorously for at least 20 seconds ….” An agency policy titled “Nursing Bag Technique” indicated but was not limited to “… Procedure: 1 … The inside of the nursing bag should be regarded and maintained as a clean area … 7. Wash and dry hands … 8. Return to the nursing bag, open it again, and remove necessary items for the visit … 10. After providing care, clean all equipment with soap and water or a home health agency-approved disinfectant before returning it to the bag ….” A home visit observation, with Patient #11, and of the Clinical Manager, was conducted on 09/01/2022 at 9:17 AM, the Clinical Manager was observed assessing the patient using a thermometer, oxygen saturation (SpO2, measurement of percentage of oxygen attached to red blood cells) probe, blood pressure cuff, stethoscope, and use of notebook. The nurse failed to perform hand hygiene prior to entering the nursing bag to obtain the supplies. After obtaining the patient’s vital signs, the nurse wiped the SpO2 probe with an alcohol wipe and immediately placed it back in its carrier, failed to allow the alcohol to dry, and failed to clean the thermometer, blood pressure cuff, stethoscope, or notebook prior to returning the items to the nursing bag and failed to complete hand hygiene before returning the items to the nurse bag. An interview was conducted on 09/02/2022 at 11:24 AM with the Administrator and Chief Financial Officer (CFO) #1. During the interview, the Administrator reported the staff should scrub their hands for “15-20 seconds” when washing with soap and water. The Administrator reported they instructed staff to clean equipment prior to using it with a patient but it was not required to clean the equipment after use on a patient and prior to returning it to the bag. The Administrator stated the nursing bag was considered “dirty.” 410 IAC 17-12-1(m)

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the aide care plan was specific to the needs of the patient for 1 of 3 patients with home health aide services (Patient #14). 1. An agency policy C-751 titled “Home Health Aide Care Plan” indicated but not limited to the purpose was to provide documentation that the client’s care was individualized to his/her specific needs. 2. Record review for Patient #14, start of care 07/05/2021, indicated a POC (plan of care) for certification period 08/29/22 to 10/27/22 indicated safety measures which included fall precautions, keep pathways clear, proper position during meals, safety in ADLs, standard precautions/ infection control, support during transfer and ambulation, and use of assistive devices. The HHA [home health aide] Care Plan document, signed by registered nurse [RN] #3 on 09/01/22 failed to include all safety precautions as listed on the POC. The POC indicated functional limitations which included bowel/ bladder incontinence, endurance, ambulation, and speech. The aide care plan failed to include all functional limitations in the POC. Activities permitted in the POC included up as tolerated, walker, and wheelchair. The aide care plan failed to include all activities permitted in the POC. 3. During an interview on 09/02/2022, the administrator confirmed the safety precautions, functional limitations, and activities permitted included on the aide care plan should match those indicated in the POC. 410 IAC 17-13-1(m)

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: July 5, 6, 7, 8, and 11, 2022 Census: 23 At this Emergency Preparedness survey, Servant’s Heart Home Health Services was found to have been in compliance with the Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers at 42 CFR 484.102. QA: A2 7/22/22

This visit was for a Federal Recertification and State Relicensure survey of a Provider in conjunction with 1 complaint investigation. Survey Dates: July 5, 6, 7, 8, and 11, 2022 Complaint #: 31900 - Unsubstantiated: Federal and state deficiencies, unrelated, were cited. Census: 23 QA: A 2 7/22/22 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. During this Federal Recertification Survey, Servant’s Heart Home Health Services was found to be out of compliance with Conditions of Participation 42 CR 484.60 Care planning, coordination of care and quality of care and 42 CFR 484.70 Infection Prevention and Control. Based on the Condition-level deficiencies during the 07/11/2022 survey, the home health agency was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 07/06/2022 at 2:37 PM. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, the agency is precluded from operating or being the site of a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 07/11/2022 and continuing through 07/10/2024.

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 observation, record review, and interview, the home health agency failed to ensure the plan of care included all pertinent diagnoses, a medication list with clear directions for administration for topical medication and indications for as needed medications, and parameters for contacting the physician for high or low vital signs (See Tag G574). Based on record review and interview, the home health agency failed to obtain physician orders prior to administering medications, treating wounds, and providing skilled nursing and home health aide services (See G580). The cumulative effect of this systemic problem resulted in the agency being out of compliance with the Condition of Participation 42 CFR 484.60 Care planning, coordination, and quality of care.

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 observation, record review, and interview, the home health agency failed to ensure the plan of care included all pertinent diagnoses, a medication list with clear directions for administration for topical medication and indications for as needed medications, and parameters for contacting the physician for high or low vital signs, for 3 of 4 active records reviewed of patients receiving skilled nursing services (Patients #1, 2, and 3). Findings include: 1. An agency policy #C-580, titled “Plan of Care,” indicated but was not limited to “Policy: Home care services are furnished under the supervision and direction of the client’s physician … Special Instructions: … 2. The Plan of Care shall be completed in full to include: a. All pertinent diagnosis(es) … l. Medications … t. Other appropriate items ….” 2. An agency policy #C-705, titled “Medication Management,” indicated but was not limited to “… Medication Orders … 1 … A complete medication order must include: … d. Special instructions for the use of the drug ... 2. Parameters for using PRN [as needed] medications including amount and frequency and any other time limitations ….” 3. The review of Patient #1’s clinical record was completed on 07/08/2022 and included a plan of care [POC] for the recertification period of 06/29/2022 – 08/27/2022. The POC indicated a start of care date of 01/05/2021, patient diagnoses included, but not limited to, post traumatic seizures and hypoglycemia (low blood sugar), and included orders for skilled nursing services for 8 hours per day, 3 days a week for 1 week, and 8 hours per day, 5 days a week for 8 weeks. The POC indicated nursing interventions included “monitor safety, [signs and symptoms] of impending seizure or hypoglycemia … For Blood sugars below 50, [nurse] to … call for emergency assistance as needed." The POC failed to evidence call parameters for high or low vital signs (basic measurements of body function, including blood pressure, heart rate, temperature, respiratory rate, and oxygen saturation (SpO2)) and high blood sugar levels, to direct when the agency nurse was to contact / alert the physician. A home visit observation was conducted on 07/06/2022 at 7:15 AM with Patient #1 and Licensed Practical Nurse (LPN) #1. During the visit, the patient obtained his own blood pressure, used an automatic blood pressure cuff, heart rate and oxygen saturation using an SpO2 monitor, temperature using a thermometer, and blood sugar using a home glucose monitor, and the nurse obtained the patient’s respiratory rate through listening to the patient’s lung sounds. LPN #1 reported the patient preferred to obtain his own vital signs, and the nurse would record them each day. 4. The review of Patient #2’s clinical record was completed on 07/07/2022 and included a POC for the recertification period of 06/13/2022 – 08/11/2022. The POC indicated a start of care date of 09/12/2016, diagnoses included, cerebral palsy, gastrostomy (surgically created opening into stomach), scoliosis (curving of the spine), and sleep apnea (condition where a person stops breathing for short intervals during sleep), and included orders for skilled nursing services for 4-8 hours per day for 5 days a week and a maximum of 60 respite skilled nursing hours per month to be used, as requested. The POC indicated nursing interventions included straight catheterization (temporary insertion of tube through urethra into bladder to drain urine, then remove tube) every 6 hours and “monitor use of Triology 100 [ventilator] … when patient is asleep.” The POC included parameters for a low oxygen saturation but failed to evidence high or low call parameters for other vital signs. The POC included medication orders, but not limited to, compression vest (percussion therapy administered to decrease secretions) twice a day and stated, “can be done total of 3 – 4 [times were day] if needed,” Desitin cream (used as a protective barrier to treat and prevent skin issues) to be applied topically (directly onto skin) as needed (PRN), Glycerin suppository (given to treat constipation) once a day as needed, Senna syrup (given to treat constipation) twice a day “if second dose needed,” acetaminophen (over-the-counter pain and fever reducer medication) every 4 hours as needed, Benadryl (over-the-counter allergy medication) every 4 hours as needed, Cetirizine (over-the-counter allergy medication) once a day, give two times a day if needed, dicyclomine (given to treat abdominal cramping) 4 times a day as needed, DuoNeb (given to treat shortness of breath or wheezing) 4 times a day as needed, Fleet Enema (given to treat constipation) once a day as needed, ibuprofen (over-the counter pain medication) every 6 hours as needed, and Polyethylene Glycol (given to treat constipation) daily or two times a day if needed. The POC failed to evidence directions on where to apply Desitin cream, failed to evidence indications for the administration for the as needed medications, Desitin, Glycerin, acetaminophen, Benadryl, dicyclomine, DuoNeb, Fleet Enema, and ibuprofen, and failed to evidence indications for administering additional doses of the compression vest, Senna syrup, Cetirizine, and Polyethylene Glycol. A home visit observation was conducted on 07/06/2022 at 8:30 AM with Patient #2 and Registered Nurse (RN) #1. During the visit, RN #1 reported the straight catheterization procedure was ordered to be done every 4 - 6 hours and they typically performed the procedure twice during an 8 hour shift. The nurse was observed administering medication to treat constipation due to slow bowel motility, GERD (Gastro-Esophageal Reflux Disease, the backflow of stomach acid into the esophagus), and seasonal allergies. The plan of care failed to evidence the frequency of straight catheterization, as reported by the nurse and failed to evidence diagnoses for the medications administered by RN#1. 5. The review of Patient #3’s clinical record was completed on 07/08/2022 and included a plan of care for a recertification period of 06/04/2022 – 08/02/2022. The plan of care indicated a start of care date of 12/06/2021, patient diagnoses included but were not limited to Chronic Obstructive Pulmonary Disease (COPD, a long term lung disease) and high blood pressure, and included orders for skilled nursing for 1 visit per week for 1 week and 3 visits per week for 8 weeks and home health aide services for 3 visits per week for 9 weeks. The plan of care indicated skilled nursing tasks were to include “[Nurse] to provide full body assessment including SpO2 and report and concerns [sic] or negative findings.” The plan of care failed to evidence call parameters for high or low vital signs. 6. An interview with the Administrator and Chief Financial Officer #1 was conducted on 07/08/2022 at 2:05 PM. During the interview, the Administrator confirmed the plan of care should include all pertinent diagnoses and a medication list with instructions for administration of topical medications and indications for administration of as needed medications. The Administrator reported the plan of care should only include vital sign call parameters if a physician had indicated specific parameters. The Administrator reported the agency did not have a set standard of vital sign call parameters in the case the physician did not specify the parameters. When asked how the nurse would know when to notify the physician if a vital sign was potentially high or low, the Administrator stated the nurse would notify the physician of “any changes in condition that would warrant concern.” 17-13-1(a)(1)(B) 17-13-1(a)(1)(C)(ix) 17-13-1(a)(1)(C)(xiii)

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to obtain physician orders prior to administering medications, treating wounds, and providing skilled nursing and home health aide services for 3 of 5 active records reviewed (Patients #1, 2, 3, and 4). Findings include: 1. An agency policy #C-635, titled “Physician’s Orders,” indicated but was not limited to “Policy: All medications, treatments and services provided to clients must be ordered by a physician … Special Instructions: 1. When the nurse or therapist receives a verbal order from the physician, he/she shall write the order as given … The order must include the date, specific order … and be sent to the physician for signature … 7. If the client or caregiver initiates changes that have been communicated to them by the physician, the nurse or therapist will write and date the order the day he/she is informed of the change ….” 2. The review of Patient #1’s clinical record was completed on 07/08/2022 and included a plan of care for the recertification period of 06/29/2022 – 08/27/2022. The plan of care indicated a start of care date of 01/05/2021, patient diagnoses included but were not limited to post traumatic seizures and hypoglycemia (low blood sugar), and included orders for skilled nursing services for 8 hours per day, 3 days a week for 1 week, and 8 hours per day, 5 days a week for 8 weeks. The record included visit notes for respite skilled nursing visits conducted on 06/29/2022 and 07/05/2022. The record failed to evidence an order for respite skilled nursing services. An interview was conducted on 07/08/2022 at 2:57 PM with the Administrator. During the interview, the Administrator confirmed Patient #1’s current plan of care or clinical record did not evidence an order for the patient’s respite skilled nursing hours. 3. The review of Patient #2’s clinical record was completed on 07/07/2022 and included a plan of care for the recertification period of 06/13/2022 – 08/11/2022. The plan of care indicated a start of care date of 09/12/2016, patient diagnoses included but were not limited to cerebral palsy, gastrostomy (surgically created opening into stomach), and scoliosis (curving of the spine), and included orders for skilled nursing services for 4-8 hours per day for 5 days a week and a maximum of 60 respite skilled nursing hours per month to be used as requested. The plan of care also indicated the skilled nurse was to “assess skin integrity for breakdown/irritation every visit.” The record indicated respite skilled nursing hours were provided on 6/13/2022, 06/14/2022, 06/15/2022, and 06/16/2022. The record failed to evidence a verbal or written physician order for recertification was obtained until 06/17/2022. The record included a respite skilled nursing visit conducted on 06/13/2022 by Registered Nurse (RN) #1. The visit note indicated Patient #2’s skin around a G/J tube (gastrostomy-jejunostomy tube, surgically placed in the stomach and small intestine for feeding and draining) was “excoriated.” The record indicated the nurse reported the excoriation to the patient’s caregiver/family member, who reported the excoriation was due to a disconnection of the G/J tube which led to stomach contents draining onto the area. RN #1 documented the area was cleansed and the nurse applied Triple Antibiotic Ointment (a cream available over-the-counter which helps prevent and treat infections of superficial skin wounds) and gauze to the area “per request” of Patient #2’s caregiver/family member. The record failed to evidence a verbal or written order for the medicated cream was obtained. The record included a respite skilled nursing visit conducted on 06/20/2022 by RN #2. The visit note indicated the nurse observed a new skin tear to Patient #2’s right elbow after the patient’s percussion vest therapy. The note indicated RN #2 notified the patient’s primary caregiver/family member, cleansed the wound, and applied Triple Antibiotic Ointment and a Band-Aid. The note also indicated during a doctor’s visit later that same day, RN #2 notified Medical Provider #1 of the new wound and treatment provided, and the provider “approved” of the treatment. The record failed to evidence a signed written was later obtained to verify the verbal order received. 4. The review of Patient #3’s clinical record was completed on 07/08/2022 and included a plan of care for a recertification period of 06/04/2022 – 08/02/2022. The plan of care indicated a start of care date of 12/06/2021, included orders for home health aide services for 3 visits per week for 9 weeks, and indicated patient diagnoses included Chronic Obstructive Pulmonary Disease (COPD, a long term lung disease), high blood pressure, and high cholesterol. The record included a written order, dated 6/16/2022 and signed by Medical Provider #2, to “evaluate and treat patient due to … pressure [wound] … of [right] buttock.” The record included a new plan of care for an initial certification period of 06/17/2022 – 08/15/2022. The plan of care indicated a new start of care of 06/17/2022 and included orders for skilled nursing for 1 visit per week for 1 week and 3 visits per week for 8 weeks and home health aide services for 3 visits per week. The plan of care indicated Patient #3’s diagnoses included but were not limited to COPD, anxiety disorder, Stage 1 pressure ulcer (type of wound caused by prolonged pressure on a body part, classified as "stages" between 1-4; a Stage 1 pressure ulcer is reddened and does not blanch but has no open areas) to the left buttock, and Stage 2 pressure ulcer (wound is opened and layers of skin are affected) of the right buttock. The plan of care included wound care orders for the skilled nurse to “cleanse [pressure ulcer] wounds with normal saline, pat dry with sterile gauze, and affix Optifoam border dressing [wound dressing] to affected area on buttock.” The record failed to evidence a verbal or written order was obtained for the new plan of care, which included the new orders for skilled nursing visits and wound care. The record included visit notes for skilled nursing visits conducted by the Clinical Manager on 06/17/2022, 06/20/2022, 06/22/2022, 06/24/2022, 06/27/2022, and 07/01/2022. The visit notes indicated the nurse changed the patient’s buttocks wounds without a physician order. The visit note dated 06/20/2022 indicated the assisted living facility’s nurse “wrote order for … calmoseptine [ointment available over-the-counter which acts as a moisture barrier and helps treat and prevent skin irritation]” for the nurse practitioner to sign. The visit note dated 06/27/2022 indicated calmoseptine was applied to both buttock wounds but the record failed to evidence a verbal or written order for the ointment was obtained prior to administration. The record included a physician order dated 06/29/2022 and written by the Clinical Manager. The order indicated both buttocks wounds were to be treated and have dressing changes 3 times per week and the wound care included “[cleanse] with wound cleanser, [pat] dry with sterile gauze and [cover] with Allevyn bordered foam [type of wound dressing].” The order also included wound care orders for a new abscess wound to the left hip. The order indicated the wound was to be “packed with gauze, covered with ABD pads [type of wound dressing] and tape,” and was to be changed “ex [sic]” times per week. The record failed to evidence the order was obtained verbally and failed to evidence the order was signed. The record included a visit note for a skilled nursing visit conducted by the Clinical Manager on 07/01/2022. The note indicated the nurse provided wound care to both buttocks and the left hip wounds. An interview was conducted on 07/11/2022 at 2:41 PM with the Clinical Manager. During the interview, the Clinical Manager confirmed they did not obtain verbal or written orders for skilled nursing services or for the wound care to be provided to Patient #3’s buttocks and left hip wounds. The Clinical Manager reported the initial order for the home health agency to evaluate and treat the patient encompassed all subsequent orders and the nurse wrote the wound care treatment orders based on her clinical knowledge and experience. 5. The review of Patient #4’s clinical record was completed on 07/11/2022 and included a plan of care for the recertification period of 07/01/2022 – 08/29/2022. The plan of care indicated a start of care date of 04/27/2022, included orders for home health aide services 1 – 5 days per week as needed per caregiver’s request for 9 weeks, and indicated patient diagnoses included but were not limited to vascular dementia and atrial fibrillation (irregular heart rhythm). The record indicated home health aide visits were conducted on 07/05/2022. The record failed to evidence a verbal or written order for recertification was obtained. 6. An interview with the Administrator and Chief Financial Officer #1 was conducted on 07/08/2022 at 2:05 PM. During the interview, the Administrator confirmed the agency’s orders for recertification of services was obtained by receiving a physician-signed plan of care and the agency did not obtain verbal orders if the signed plan of care was not returned prior to the start of the new certification period. The Administrator reported a patient’s initial order for services was considered the order for services until the patient was discharged. A follow up interview was conducted with the Administrator on 07/11/2022 at 2:10 PM. During the interview, the Administrator confirmed a verbal or written physician order should be obtained prior to administration of a medication or treatment. 17-13-1(a)(1)(B)

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to develop policies and procedures regarding staff COVID-19 vaccination which included staff positions and roles for whom the COVID-19 vaccination was required, additional precautions for all staff not fully vaccinated for COVID-19 to mitigate the spread, a process for staff request and agency review of religious exemption to the COVID-19 vaccination requirement, and a process for tracking and securely documenting the status of fully vaccinated, partially vaccinated, medical or religious exempted, and temporary delayed vaccination status of all required staff (See G687). The cumulative effect of this systemic problem resulted in the agency being out of compliance with the Condition of Participation 42 CFR 484.70.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to develop policies and procedures regarding staff COVID-19 vaccination to include staff positions and roles for whom the COVID-19 vaccination was required, additional precautions for all staff not fully vaccinated for COVID-19 to mitigate the spread, a process for staff request and agency review of religious exemption to the COVID-19 vaccination requirement, and a process for tracking and securely documenting the status of fully vaccinated, partially vaccinated, medical or religious exempted, and temporary delayed vaccination status of all required staff, which had the potential to affect all patients and agency staff for 1 of 1 agency. Findings include: 1. An agency policy titled “COVID-19 Infection Control Policy” indicated but was not limited to “1 … Staff members will not be required to receive the COVID vaccine, but should maintain proper PPE [personal protective equipment, such as gloves, gowns, masks, etc] and infection control measures and complete the COVID screening questions daily on [electronic medical record (EMR) system] … If a staff member receives the COVID vaccine, they should notify the administrator for their health record. If a staff member has a medical or religious exemption reason for not taking the vaccine, this will be noted on their medical record by the administrator. If there is a medical reason for not having the vaccine, the staff member should have a copy of the vaccine medical exemption form completed by their physician ….” The policy failed to evidence staff positions and roles for whom the COVID-19 vaccination was required additional precautions for all staff not fully vaccinated for COVID-19 to mitigate the spread, a process for staff request and agency review of a religious exemption to the COVID-19 vaccination requirement, and a process for tracking and securely documenting the status of fully vaccinated, partially vaccinated, medical or religious exempted, and temporary delayed vaccination status of all required staff. The policy also failed to evidence a date the policy was enacted by the agency. 2. A document titled “Servant’s Heart Home Health Services, Inc. Professional Advisory Board: Meeting Minutes October 2021,” confirmed by the Administrator as the minutes from the agency’s most recent governing body meeting, indicated but was not limited to “… Infection control for Staff and Patients: … C. Vaccine mandate concerns have caused some staff members to have anxiety over losing their jobs versus refusing the vaccine. At this time we have no mandate in place and we are waiting to see if these mandates are enforced by CMS ….” 3. An interview was conducted on 07/05/2022 at 2:42 PM with the Administrator. During the interview, the Administrator reported there was no formal process for staff request and agency review of COVID-19 vaccine religious exemptions. The Administrator reported staff wanting a religious exemption would tell her verbally they wanted a religious exemption and she documented this on the agency’s vaccination log. The Administrator was unsure of the process for agency review of medical exemption for the COVID-19 vaccine, 4. An interview was conducted on 07/05/2022 at 4:18 PM with the Administrator who confirmed the governing body was responsible for reviewing and approving all new policies and any policy changes. The Administrator reported the governing body last reviewed the agency’s “COVID-19 Infection Control” policy for updates regarding the vaccine mandate at the October 2021 meeting. The Administrator reviewed the meeting minutes from the October 2021 meeting but was unable to state where the review and approval of the policy changes was documented. The Administrator confirmed the agency had no other policies regarding COVID-19 or vaccination requirements of staff. The Administrator reported the agency had no additional precautions in place for non-vaccinated staff to mitigate the spread of COVID-19. The Administrator reported they were not familiar with the regulation requiring COVID-19 vaccination of agency staff or the regulation’s requirements regarding agency policies and procedures on employee COVID-19 vaccination. 17-12-1(m)

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the Registered Nurse (RN) failed to perform a complete comprehensive and skilled nurse visit assessment for 1 of 2 active pediatric patient records reviewed (RN #2). Findings include: 1. An agency policy #C-148, titled “Pain Assessment/Management,” indicated but was not limited to “… Special Instructions: … 3. Pain is assessed on every home visit and documented … 4. The nurse … will use a standardized agency accepted pain assessment tool that evaluates the … severity (rating scale) [of pain] ….” 2. An agency job description for the role of RN indicated but was not limited to “… II … the registered nurse shall do the following: … h. Accept and carry out physician … orders … i. Assist the physician … in evaluating level of function ….” 3. The review of Patient #5’s clinical record was completed on 07/11/2022 and included a plan of care for the recertification period of 06/22/2022 – 08/20/2022. The plan of care indicated a start of care date of 03/04/2020, patient diagnoses including but not limited to shaken infant syndrome, encephalopathy (disease resulting in impaired brain function), and “other disorders of psychological development,” and included orders for skilled nursing services of “up to 8 hours per visit,” 3 times a week for 1 week, then 5 times a week for 8 weeks, with a maximum limit of 45 hours per week. The plan of care indicated nursing tasks were to include “GT [G-tube, a tube surgically placed into the stomach for feeding and/or draining] feedings … and safety in the absence of [the primary caregiver].” The plan of care included parameters for MD notification for a high or low temperature, high or low pulse, high or low respiratory rate, and low oxygen saturation level. The record included a recertification comprehensive assessment completed on 06/20/2022 and skilled nurse visits completed on 06/27/2022, 06/28/2022, 06/29/2022, and 07/01/2022 by RN #2. The comprehensive assessment and visit notes failed to evidence an assessment of the patient’s pain and the amount of tube feeding residual (volume remaining in the stomach after artificial feeding administered). The skilled nurse visit notes indicated the nurse assessed the patient’s respiratory rate but failed to evidence the nurse assessed the patient’s other vital signs (basic measurements of body function) of temperature, pulse, and oxygen saturation. An interview was conducted on 07/11/2022 at 1:45 PM with RN #2. During the interview, RN #2 reported there “really isn’t a way” to assess Patient #5’s pain using a standardized pain rating scale. The nurse reported she assessed the patient for the presence or absence of pain by “[paying] attention if giving physical cues … the way [the patient’s] acting.” The nurse reported Patient #5 had an order for as needed Tylenol for pain relief, but when asked how the nurse determined when to administer the medication, the nurse reported “only if [the patient was] running a fever.” RN #2 also reported she could only assess Patient #5’s respiratory rate, as the patient was not compliant with other vital sign assessments and Patient #5’s primary caregiver refused tube feeding residual checks. When asked if the primary caregiver’s refusal of tube feeding residual checks was documented within the clinical record, RN #2 reported she was unsure. 4. An interview was conducted on 07/11/2022 at 2:10 PM with the Administrator. During the interview, the Administrator reported the agency had a standardized pain rating scale “built in to” the Electronic Medical Record (EMR) that all staff should complete with every visit. The Administrator reported Patient #5’s medical history prevents staff from using the standardized pain rating scale, so staff should use nonverbal cues such as crying or fussiness to assess if pain is present. The Administrator confirmed the presence or absence of the non-verbal cues should be documented by staff. The Administrator also reported tube feeding residual should be assessed as ordered by the physician and if the patient or caregiver refused this assessment, this should be documented in the record. The Administrator confirmed vital signs should be assessed and documented with every skilled nurse visit.

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 observation, record review, and interview, the Licensed Practical Nurse (LPN) failed to ensure all patient medications were not expired for 1 of 1 home visit observations of an agency licensed practical nurse (LPN #1). Findings include: 1. An agency policy #C-705, titled “Medication Management,” indicated but was not limited to “… Program Specifics: … Medications in the home are reviewed with the client/family … All expired, damaged, or contaminated medications will be removed from the home … In the event that emergency medications are kept in the home, location of the medication and proper storage guidelines will be identified and documented ….” 2. The review of Patient #1’s clinical record was completed on 07/08/2022 and included a plan of care for the recertification period of 06/29/2022 – 08/27/2022. The plan of care indicated a start of care date of 01/05/2021, patient diagnoses included but were not limited to post traumatic seizures and hypoglycemia (low blood sugar), and included orders for skilled nursing services for 8 hours per day, 3 days a week for 1 week, and 8 hours per day, 5 days a week for 8 weeks. The plan of care included nurse tasks and interventions included but were not limited to “Hours to be provided while [patient’s family member] is at work in order to keep [Patient #1] safe. [Skilled nurse] to monitor safety, [signs and symptoms] … of impending hypoglycemia. Nurse to administer emergency medications … for blood sugars below 50, [skilled nurse] to give 1 [milligram subcutaneous] of Glucagon [medication given to increase blood sugar quickly] ....” A home visit observation was conducted on 07/06/2022 at 7:15 AM with Patient #1 and Licensed Practical Nurse (LPN) #1. During the visit, a backpack with emergency medications and supplies was observed. LPN #1 reported the patient took the backpack whenever they were outside of the house in case of emergencies. One single-dose vial of Glucagon with an expiration date of 01/2021 was observed in the backpack. Patient #1 reported a refill was requested from the pharmacy “yesterday” when the patient and nurse discovered the medication was expired. 3. An interview was conducted on 07/06/2022 at 2:22 PM with the Administrator who confirmed the skilled nurse should periodically check all of Patient #1’s emergency medications to ensure there are no expired medications. 17-14-1(a)(1)(H)

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the governing body failed to ensure the agency adhered to its Medicare agreement to accept and bill Medicare-covered patients, which had the potential to affect all referred and current patients for 1 of 1 agency. Findings include: 1. An agency policy #B-100, titled “Governing Body,” indicated but was not limited to “Policy: The Governing Body shall assume full legal authority and responsibility for the operation of Servant’s Heart Home Health Services … Special Instructions: The duties and responsibilities of the Governing Body shall include: … Oversee the management and fiscal affairs of the agency. This shall include … organizational operations ….” 2. The survey Entrance Conference was conducted on 07/05/2022 at 12:08 PM with the Administrator, Branch Manager #1, and Chief Financial Office (CFO) #1. During the conference, the Administrator reported the agency was certified by Medicare but the agency did not have any Medicare patients on their current census. 3. An interview was conducted on 07/06/2022 at 2:22 PM with the Administrator and CFO #1. During the interview, the Administrator reported the agency had attempted to provide home health services to Medicare patients, was unable to provide these services and remain financially viable, therefore decided in 2014 to no longer accept referrals for Medicare services. The Administrator relayed the agency did report their no utilization of Medicare benefits to their Medicare Administrative Contractor (MAC) yearly. 4. A letter dated 01/05/2021 written on agency letterhead, addressed to the agency’s MAC and signed by the Administrator, indicated the agency notified the MAC there had been “no utilization of Medicare during the last year” and the agency had not “had any Medicare patients for more than 3 years.” 5. A follow-up interview was conducted on 07/08/2022 at 10:20 AM with the Administrator and CFO #1. During the interview, the Administrator confirmed if the agency received a referral for home care services, to be billed under Medicare, the agency would not accept the patient and would refer the patient to another agency. The Administrator and CFO #1 were unsure if any of their current patients were eligible for Medicare benefits. The Administrator stated if a patient was receiving home health services from Servant’s Heart and started to receive Medicare home health services from another agency, Servant’s Heart Home Health Services would discharge the patient. When asked if the agency had received any referrals for home care services to be billed to Medicare, the Administrator was unable to answer definitively. The Administrator confirmed the list of referred patients within the last 12 months was not up-to-date. The Administrator stated the Governing Body had not discussed the agency’s inability to accept Medicare patients since 2015. 6. The meeting minutes from the agency’s Governing Body meetings held on 10/25/2019, 10/20202, and 10/2021, confirmed by the Administrator as the minutes from the agency’s last 3 governing body meetings, were reviewed on 07/08/2022. The minutes failed to evidence the governing body discussed the agency’s Medicare agreement and denial of all Medicare-insured patients to determine if the agreement terms were met. 7. The review of Patient #1’s clinical record was completed on 07/08/2022 and included a plan of care for the certification period of 06/29/2022 – 08/27/2022. The plan of care indicated a start of care date of 01/05/2021 and included orders for skilled nursing services for 8 hours per day, 3 days per week for 1 week then 8 hours per day, 5 days per week for 8 weeks. The record included a copy of a fax dated 10/27/2020 sent by the Administrator to Home Health Agency #2. The fax included a “Coordination of Care for Facilities or Other Providers” document, signed by the Administrator on 10/27/2020 and the clinical manager of Home Health Agency #1 on the same day, which indicated the agency was to provide skilled nursing services through Medicaid and Home Health Agency #2 was to provide physical therapy visits “only through Medicare” to Patient #1. The fax also included a copy of the agency’s plan of care for the certification period of 10/18/2020 – 12/16/2020, which indicated a start of care of 07/05/2017. 17-12-1(b)(3)