Every finding on record at Noble Home Health Care LLC

Highland, Indiana · CCN 157650

82 findings across 4 surveys, in the inspector's own words.

The inspector’s own words from form CMS-2567, unedited, including CMS’s own spacing. Names and some dates are redacted by CMS.

Survey of April 30, 2025

19 findings

E0000

An Emergency Preparedness Survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. Survey Dates: 4/22/2025 – 4/25/2025 and 4/28/2025 – 4/30/2025 Unduplicated Skilled Admissions for the last 12 Months: 15 At this Emergency Preparedness survey, Noble Home Health Care, LLC, was found in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102. A1

G0000

This visit was for a Federal Recertification and State Re-Licensure survey of a home health provider. Survey Date: 4/22/2025 – 4/25/2025 and 4/28/2025 – 4/30/2025 Unduplicated Skilled Admissions for the last 12 Months: 15 During this Federal Recertification Survey, Noble Home Health Care LLC was found to be out of compliance with Condition of Participation at 42 CFR 484.105 Organization and administration of services. Based on the Condition-level deficiencies during the April 30, 2025 survey, Noble Home Health Care LLC was subject to an extended survey on April 22, 2025, pursuant to section 1891(c)(2)(D) of the Social Security Act. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training, skills competency, and/or competency evaluation program for a period of two years beginning April 30, 2025 and continuing through April 29, 2027. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. Abbreviations used in report: POC – Plan of Care, CM – Clinical Manager, SOC - Start of Care, HHA - Home Health Aide, RN - Registered Nurse, LPN - Licensed Practical Nurse, SN - Skilled Nurse. QR: A1 5/06/2025

G0528

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (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 agency failed to ensure the comprehensive assessment included the physical status of the patient in 1 of 1 active clinical record review with a gastrostomy (GT, a feeding tube) (Patient #1) and in 1 of 1 active clinical record reviewed with a wound (Patient #5). The findings include: 1. During an observation of care on 04/23/2025, at 11:05 AM, Patient #1 was observed with a tube inserted into the abdomen connected to a bag containing a liquid. A clinical record review evidenced a comprehensive assessment [CA] for recertification, dated 04/11/2025 completed by RN 1, which indicated Patient had a GT for enteral nutrition (provided via a feeding tube directly into the stomach) and indicated Patient received oxygen at 2 liters per minute (the rate of oxygen administration. The CA failed to include the size of the feeding tube and the appearance of the stoma (opening of the skin for the tube) and surrounding skin and failed to include the method of oxygen delivery and frequency. On 04/25/2025, at 4:25 PM, RN 1 indicated the GT was a Mickey button (type of feeding tube) and the size was 14 French (unit of measure for feeding tube) and 2.0 centimeters in length with a balloon to hold it in place filled with 3 milliliters of air. RN 1 indicated the Patient received oxygen as needed via nasal cannula (a tube inserted into the nostrils) to maintain oxygen saturation levels. On 04/30/2025, at 1:41 PM, the Alternate CM indicated the assessment of the feeding tube size and the appearance of the stoma and surrounding skin was not included in the comprehensive assessment and indicated the comprehensive assessment did not include the frequency and method of oxygen delivery. 2. A clinical record review for Patient #5 evidenced a comprehensive assessment for the SOC dated 03/24/2025 completed by the Alternate CM which indicated the Patient had a dressing covering the left heel due to a wound for which Entity 5 provided wound treatment. The comprehensive assessment failed to include an assessment of the wound. The clinical record failed to evidence an order that indicated the wound dressing was not to be removed and failed to evidence any assessment of the wound provided by Entity 5. The assessment indicated Patient received dialysis (a medical treatment that filters the blood) and had a central venous catheter (an thin tube going into a large vein) at the right subclavian (a vein under the upper chest) and failed to include the assessment of the site to include if a dressing was present. On 04/30/2025, at 2:03 PM, the Alternate CM indicated she did not assess the wound to the left foot due to Patient #5 had a dressing in place covering the wound that was applied by Entity 5 and she did not want to remove the dressing. She indicated she did not have an assessment of the wound from Entity 5 and did not include an assessment of the central venous catheter to include a dressing was present over the site. 410 IAC 17-14-1(a)(1)(B)

G0536

G0538

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included the assessment of the caregiver’s willingness, ability, and capability to provide care in 3 of 3 active clinical records reviewed with a caregiver. (Patient #1, 4, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a comprehensive assessment for recertification dated 04/11/2025 which indicated the Patient was wheelchair bound and dependent on others for personal care and activities of daily living, feeding, and medication administration. The comprehensive assessment failed to identify who the caregiver was and the willingness, ability, and availability of the caregiver in the absence of the home health services. On 04/30/2025, at 1:41 PM, the CM indicated the assessment of the caregiver was not included in the comprehensive assessment. 2. A clinical record review for Patient #4 evidenced a comprehensive assessment for the SOC dated 03/31/2025 which indicated the Patient required seizure precautions and was dependent for personal care and activities of daily living, feeding, and medication administration. The comprehensive assessment failed to identify the willingness and ability of the caregiver in the absence of the home health services. On 04/30/2025, at 1:27 PM, the CM indicated the comprehensive assessment did not include the ability and willingness of the caregiver to provide care. 3. A clinical record review for Patient #5 evidenced a comprehensive assessment for the SOC dated 03/24/2025, which indicated the Patient had a wound and lived with a caregiver, and the assessment failed to include the assessment of the caregiver. On 04/30/2025, at 2:00 PM, the Alternate CM indicated the comprehensive assessment did not include an assessment of the caregiver. 4. On 04/30/2025, at 1:45 PM, the Alternate CM indicated there was not a space for the assessment of the caregiver on the recertification comprehensive assessment form.

G0562

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide a 15-day discharge notice before the date of discharge in 1 of 1 closed clinical records reviewed due to goals met. (Patient #7) The findings include: A policy updated 04/23/2025 titled “Discharge/Transfer from Service” indicated the agency would notify the patient no later than 15 days before the date on which the discharge would take place and would document the notice of discharge in the clinical record. A clinical record review for Patient #7 evidenced the Patient was discharged on 01/21/2025 and evidenced a letter addressed to the Patient dated 01/14/2025 which indicated the Patient would be discharged from the agency effective 01/21/2025 which was less than 15 days. On 04/30/2025, beginning at 1:05 PM, the Administrator indicated there was no additional documentation to indicate the agency provided discharge notice prior to 01/14/2025. 410 IAC 17-12-2(i)

G0564

G0572

G0574

G0580

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 observation, record review, and interview, the agency failed to ensure skin treatment was provided only as ordered by the physician in 1 of 1 observation with a LPN. (Patient #3) The findings include: A clinical record review for Patient #3 evidenced POC for recertification periods 02/27/2025- 04/27/2025 and 04/28/2025- 07/28/2025 indicated the SN was to provide pressure ulcer (wounds from pressure to the skin) prevention care to the right buttock to include cleansing the wound with normal saline (wound cleanser), applying skin preparation (a skin conditioner), and bordered gauze. During an observation of care at Patient’s home, on 04/29/2025 at 12:00 PM, LPN 1 was observed applying a substance from a package labeled “alginate (a wound dressing used to absorb drainage) and a bordered foam dressing to the right buttock area. The SN visit notes completed by LPN 1 and dated 03/04/2025, 03/11/2025, 03/18/2025, 03/25/2025, 04/01/2025, 04/10/2025, 04/15/2025, and 04/22/2025 indicated LPN 1 applied silver alginate and foam dressing. The clinical record failed to evidence a physician order for the alginate and foam dressing. On 04/29/2025, beginning at 12:04 PM, LPN 1 indicated she applied the alginate every time, because it helped with the healing process. On 04/30/2025, at 2:18 PM, the Alternate CM indicated she could not find the order for the alginate and foam dressing. The Alternate CM indicated the list of supplies documented on a physician order was not an order for the use of the alginate and foam dressing. 410 IAC 17-13-1(a)

G0584

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure verbal orders were written and send to the physician for signature in 1 of 2 active clinical records reviewed with a SOC in 2025. (Patient #4) The findings include: A policy titled “Physician Orders/Plan of Care” updated 04/23/2025 indicated the agency would ensure verbal orders would put into writing, signed and dated by the person receiving the order, and be signed by the physician. A clinical record review for Patient #4 evidenced an initial assessment dated 03/28/2025 completed by the CM which indicated the verbal SOC order was received from the physician. The clinical record failed to evidence the CM sent the verbal order to the physician to be signed. On 04/30/2025, at 1:25 PM, the CM indicated the verbal order was not sent to the physician for signature and just documented on the initial assessment. 410 IAC 17-14-1(a)(H)

G0606

G0646

Program activities CFR(s): 484.65(c) (1) The HHA's performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Quality Assurance and Performance Improvement (QAPI) program included performance improvement activities for high risk and high frequency areas. The findings include: A review of the hospitalization log for 2025 indicated 6 hospitalizations with an average census of 25. The QAPI program failed to evidence performance improvement activities to address the hospitalizations. On 04/30/2025, at 2:48 PM, the CM indicated the agency had not implemented any performance improvement activities to address the patient hospitalizations.

G0798

G0800

G0940

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview the Governing Body and Administrator failed to ensure the Medicare Provider met the Condition of Participation for Organization and Administration of Services when they failed to provide skilled services to individuals, eligible to receive skilled home health services under their Medicare benefit (See G 942) for 1 of 1 Medicare provider.

G0942

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 administrator adhered to the agencies Medicare agreement to accept and provide services to Medicare eligible beneficiaries and the declination to provide skilled services to Medicare beneficiaries, for 1 of 1 agency. Findings include: During the Entrance Conference, conducted on 04/22/2025, beginning at 10:40 AM, the Administrator reported the agency was certified by Medicare, but the agency did not have any Medicare patients on their current census and had not for at least five years. Review of the active patient roster failed to evidence the agency provided services for Medicare patients. Review of the Governing Body Meeting Minutes from 2023, 2024, and 2025 failed to evidence any discussion regarding the failure to accept and provide services to Medicare patients. On 04/22/2025, at 2:20 PM, the Administrator indicated the agency had not provided services for any Medicare patients since she was hired on 12/19/2019. The Administrator indicated the agency did not have SN staff that wanted to provide the intermittent Medicare visits. The administrator relayed any referrals received for Medicare services were referred to another home health agency.

G1022

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge summary was sent to the physician within 2 business days in 2 of 2 closed clinical records reviewed. (Patient #6 and 7) 1. The revised policy, dated 04/23/2025 and titled “Discharge/Transfer from Service” indicated the agency would send the physician a discharge summary within 2 business days of discharge. 2. The clinical record for Patient #6 evidenced Patient was discharged from the agency on 04/10/2025; the record failed to evidence a discharge summary was sent to the physician. 3. The clinical record for Patient #7 evidenced Patient was discharged on 01/21/2025; the record failed to evidence a discharge summary was sent to the physician. 4. On 04/30/2025, at 12:40 PM, the Administrator indicated the agency did send a discharge summary to the physician of Patient 6 nor Patient #7. 410 IAC 17-13-2(a)(9)

G1024

Survey of June 14, 2022

33 findings

E0000

An Emergency Preparedness survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Facility ID: 012829 Survey dates: 6/7/2022, 6/8/2022, 6/9/2022, 6/10/2022, 6/13/2022, and 6/14/2022 At this Emergency Preparedness survey, Noble Home Health Care LLC., was found to not be in compliance with 42 CFR 484.102, Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers.

E0001

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed: to develop and maintain an emergency preparedness plan which was updated and reviewed at least every 2 years (see tag E0004); develop and maintain a comprehensive emergency preparedness plan which included an all-hazards risk assessment based on a facility-based and community-based risk assessment; and failed to include strategies for addressing emergency events identified by the risk assessment (see tag E0006); to develop and implement individualized emergency preparedness plans for the patients which provided appropriate instructions, in the event of an emergency, to communicate with the agency (see tag E0017); to ensure the policies and procedures for emergency preparedness included procedures to inform state emergency preparedness officials of patients in need of evacuation based on the patient’s medical/psychiatric condition and home environment (see tag E0019); to ensure a policy included a system for medical documentation that preserves patient information, protects patient confidentiality, and secures and maintains availability of records in the event of an emergency (see tag E0023); to ensure a policy included the use of volunteers or other emergency staffing in the event of an emergency (see tag E0024); to develop and maintain an emergency preparedness communication plan which included contact information for federal emergency preparedness staff (see tag E0031); to maintain documentation of all emergency preparedness training and failed to demonstrate staff knowledge of emergency procedures (see tag E0037); and to conduct and document exercises to test the emergency plan annually (see tag E0039). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment and resulted in the agency being found out of compliance with the condition 42 CFR 484.102 Emergency preparedness.

E0004

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness plan which was updated and reviewed at least every 2 years. The findings include: Review of the agency’s Emergency Preparedness Binder on 6/8/2022 evidenced the most recent all-hazards risk assessment was completed in 2018. Review failed to evidence any updates to the risk assessment since 2018. During an interview on 6/8/2022 at 2:06PM, when queried how the emergency preparedness plan was developed, administrator A stated, “… the prior DON [director of nursing] was involved in all of that … when she left abruptly, she didn’t pass that along ….” At 2:07 PM, administrator A indicated the agency did not document any updates to the emergency preparedness plan. Administrator A indicated the risk assessment had not been updated since 2018.

E0006

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain a comprehensive emergency preparedness plan which included an all-hazards risk assessment based on a facility-based and community-based risk assessment; and failed to include strategies for addressing emergency events identified by the risk assessment. The findings include: Record review on 6/8/2022 evidenced an agency policy revised 6/7/2022, titled “Disaster/Emergency Preparedness” which stated, “… This plan uses the term ‘all hazard’ to address all types of incidents. An incident is an occurrence, caused either by humans or by a natural phenomenon, which requires or may require action by home care and emergency service personnel to prevent or minimize loss of life or damage to property and/or the environment … Specific measures will be made for anticipated emergencies typical or appropriate for the geographical area served ….” Record review on 6/8/2022 evidenced a “Hazard and Vulnerability Assessment Tool for Naturally Occurring Events” dated 2018, which indicated a 50% risk of acts of intent, 57% risk of civil unrest, and 47% risk of external flood. Review failed to evidence a current all-hazards risk assessment. Review of the agency’s Emergency Preparedness binder on 6/8/2022 failed to evidence strategies for addressing the risk for acts of intent, civil unrest, and external flood as identified by the risk assessment. The emergency preparedness binder failed to include any strategies for addressing specific risks. During an interview on 6/8/2022 at 2:07 PM, registered nurse B indicated the current risk assessment was not in the emergency preparedness binder, but they would put it there once they received the risk assessment. When queried what emergency strategies should be included in the emergency plan, registered nurse B stated, “… it’s based on what disasters have already occurred, and what is likely to occur … we go according to things that can happen here and how it’s going to affect the patients in their home ….” Administrator A indicated the strategies for addressing the risks should be included in the emergency preparedness plan.

E0017

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the individualized emergency preparedness plans for each patient included specific patient care information or evacuation locations for 7 of 7 clinical records reviewed. (#1, 2, 3, 4, 5, 6, 7) The findings include: 1. Record review on 6/8/2022 evidenced an agency policy updated 6/7/2022, titled “Disaster/Emergency Preparedness” which stated, “… On admission, the admitting nurse will assign each patient a priority code, dictating that patient’s emergency rating. The admitting nurse will obtain a list of contact numbers, and discuss emergency planning options with the patient and family. All information will be kept in the patient’s chart and shall be kept in paper as well as electronic format. At that time, each patient will be given a list of items to have prepared and available for use in the event of an emergency ….” 2. Observation of a home visit for patient #1 was conducted on 6/8/2022 at 8:00 AM to observe a routine home health aide visit. During the visit, a home folder was reviewed which contained an emergency preparedness plan. This plan failed to indicate any specific emergency instructions/needs for patient #1 and failed to include an evacuation location. 3. Observation of a home visit for patient #2 was conducted on 6/9/2022 at 2:00 PM to observe a routine skilled nurse visit. During the visit, a home folder was reviewed which contained an emergency preparedness plan. This plan failed to indicate any specific emergency instructions/needs for patient #2 and failed to include an evacuation location. 4. Observation of a home visit for patient #3 was conducted on 6/10/2022 at 8:41 AM to observe a routine home health aide visit. During the visit, a home folder was reviewed which contained an emergency preparedness plan. This plan failed to indicate any specific emergency instructions/needs for patient #3 and failed to include an evacuation location. 5. Record review for patient #4 was completed on 6/13/2022. Review evidenced an emergency preparedness plan which failed to indicate any specific emergency instructions/needs for patient #4 and failed to include an evacuation location. 6. Record review for patient #5 was completed on 6/13/2022. Review evidenced an emergency preparedness plan which failed to indicate any specific emergency instructions/needs for patient #5 and failed to include an evacuation location. 7. Record review for patient #6 was completed on 6/13/2022. Review evidenced an emergency preparedness plan which failed to indicate any specific emergency instructions/needs for patient #6 and failed to include an evacuation location. 8. Record review for patient #7 was completed on 6/13/2022. Review evidenced an emergency preparedness plan which failed to indicate any specific emergency instructions/needs for patient #7 and failed to include an evacuation location. 9. During an interview on 6/8/2022 at 11:45 AM, administrator A identified the individualized emergency preparedness plans as the emergency preparedness/risk/triage paper located in patient’s home folders. During an interview on 6/13/2022 at 11:46 AM, registered nurse B stated, when queried how the agency individualized each patient’s emergency preparedness plan, “… that’s up to EMS [emergency medical services] and the hospitals where the patient goes … we use the triage codes assigned … we don’t have specific evacuation locations for patient ….”

E0019

Homebound HHA/Hospice Inform EP Officials CFR(s): 484.102(b)(2) §418.113(b)(2), §460.84(b)(4), §484.102(b)(2) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] *[For homebound Hospice at §418.113(b)(2), PACE at §460.84(b)(4), and HHAs at §484.102(b)(2):] The procedures to inform State and local emergency preparedness officials about [homebound Hospice, PACE or HHA] patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the policies and procedures for emergency preparedness included procedures to inform state emergency preparedness officials of patients in need of evacuation based on the patient’s medical/psychiatric condition and home environment. The findings include: Record review on 6/8/2022 evidenced an agency policy updated 6/7/2022, titled “… Disaster/Emergency Preparedness” which stated, “… Keep track of where the patient is going and all necessary telephone numbers, or contact the Emergency Supervisor for arrangements to be made through the county emergency planners for transportation to an alternate care facility if other arrangements cannot be made ….” Record review failed to evidence the emergency preparedness policies/procedures included procedures to inform state officials of patient’s need of evacuation. During an interview on 6/8/2022 at 2:25 PM, registered nurse B stated, when queried how the agency plans to notify officials if a patient needs evacuation, “… If a patient needs to be evacuated, we need to call local services and have them evacuated from the home ….” Registered nurse B and administrator A indicated they did not know if the agency was required to contact state officials for evacuation.

E0023

Policies/Procedures for Medical Documentation CFR(s): 484.102(b)(4) §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness policies and procedures included a system of medical documentation that preserved patient information, protected confidentiality, and secured and maintained the availability of records. The findings include: Record review on 6/8/2022 evidenced an agency policy revised 6/7/2022 titled “Disaster/Emergency Preparedness” which failed to evidence a system for medical documentation which maintained confidentiality, preserved patient information, and maintained the availability of records. During an interview on 6/8/2022 at 2:32 PM, registered nurse B stated, when queried how the agency would document in an emergency situation, “… we would document on paper and store it in a locked box … it’s probably not in the policy, but we will get it added ….”

E0024

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan policies included emergency staffing for addressing surge needs. The findings include: Record review on 6/8/2022 evidenced an agency policy updated 6/7/2022, titled “Disaster/Emergency Preparedness” which failed to include use of volunteers or other emergency staffing procedures. During an interview on 6/8/2022 at 2:34 PM, administrator A indicated the agency does not use volunteers. When queried how the agency would handle a surge of patients, administrator A stated, “… depending on the staff we could go down on staffing, like a nurse could become an aide … we would use a triage system and use all available staff … we would communicate with the patient’s and the family members to see if they can provide their own care or if we need, we could collaborate with another agency ….” Administrator A indicated the emergency staffing was not addressed in the emergency preparedness policy.

E0031

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included contact information for federal emergency preparedness staff. The findings include: Record review on 6/8/2022 evidenced an emergency preparedness binder which failed to include contact information for federal emergency preparedness staff. During an interview on 6/8/2022 at 2:40 PM, registered nurse B stated, when queried if the communication plan includes contact information for federal emergency preparedness staff, “… we don’t contact FEMA [federal emergency management agency], we call local emergency preparedness officials, and they call the department of homeland security … we have FEMA’s website in there [the emergency preparedness binder] ….”

E0037

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to maintain documentation of all emergency preparedness training and failed to demonstrate staff knowledge of emergency procedures. The findings include: Record review on 6/8/2022 evidenced an agency policy updated 6/7/2022, titled “Disaster/Emergency Preparedness” which stated, “… Employees will be oriented on the emergency plan during the new hire process and annually ….” Record review on 6/9/2022 of employee records failed to evidence documentation of any staff emergency preparedness training. During an interview on 6/10/2022 at 2:00 PM, administrator A indicated the agency conducts emergency preparedness training for all staff but was not sure where it was documented or how frequently the training was conducted. Administrator A requested the documentation from the employee C. Surveyor requested staff emergency preparedness training on 6/10/2022 at 2:00 PM, and no further information was provided upon exit.

E0039

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to maintain documentation of all drills, tabletop exercises, and emergency events. The findings include: Record review on 6/8/2022 evidenced a document dated 11/14/2019, titled “Funnel Vision Full Scale Exercise” which indicated the agency participated in a full-scale emergency preparedness exercise in 2019. Record review on 6/8/2022 evidenced a Certificate of Participation for a 2021 Great Central U.S. ShakeOut Multi-State Earthquake Drill. Record review failed to evidence the agency participated in a full-scale emergency preparedness exercise every 2 years. Record review on 6/8/2022 failed to evidence the agency conducted an additional emergency preparedness exercise at least every 2 years, in the opposite year of the full-scale exercise. During an interview on 6/8/2022, at 2:53 PM, when queried if the agency conducted emergency preparedness exercises, administrator A indicated in 2020 the agency and staff participated in a phone tree drill. When queried about documentation of this drill, and specifics of the 2021 drill, administrator A stated, “… We have a copy of the blank review form from the earthquake drill, all the staff participated if they were working during it … we don’t have documentation of the calls or what happened and don’t have documentation in the book of what happened during the earthquake drill or who was there ….”

G0000

This visit was for a Federal Recertification and State Re-licensure survey. Facility ID: 012829 Survey Dates: 6/7/2022 - 6/14/2022 Noble Home Health Care LLC., is precluded from providing its own home health aide training and competency evaluation for a period of two years from 6/14/2022 – 06/14/2024, due to being found out of compliance with Conditions of Participation 484.60 Care Planning, Coordination of Care and Quality of Care, 484.65 Quality Assessment and Performance Improvement, and 484.70 Infection Prevention and Control. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Quality Review Completed 06/29/2022

G0374

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the OASIS [outcome and assessment information set] accurately reflected patient’s status at time of assessment in 5 of 7 clinical records reviewed. (#2, 3, 4, 6, 7) The findings include: 1. Record review on 6/14/2022 evidenced an agency policy updated 6/10/2021, titled “Comprehensive Assessment of Patients [OASIS]” which stated, “… The OASIS [outcome and assessment information set] data collected must accurately reflect the patient’s status at the time of the assessment ….” 2. Clinical record review for patient #2 was completed on 6/13/2022, for certification period 4/14/2022 – 6/12/2022. Record review evidenced an OASIS start of care/comprehensive assessment dated 4/14/2022 which included a section titled “[M0104] Date of Referral” which was incomplete. This document contained a section titled “[M1610] Urinary Incontinence or Urinary Catheter Presence:” which indicated patient #2 was not incontinent due to a urinary catheter. This document contained a section titled “[M1620] Bowel Incontinence Frequency” which indicated patient very rarely or never had bowel incontinence. This document also included a fall risk assessment which stated, “… Incontinence: … Yes ….” The comprehensive assessment/OASIS start of care failed to accurately reflect the patient’s incontinent status at time of assessment. This document contained a section titled “[M1910] Has this patient had a multi-factor Fall Risk Assessment using a standardized, validated assessment tool?” which stated, “… No ….” This document did have a standardized fall risk assessment tool which was completed, and rated patient at a score of 6, which indicated a risk for falling. This document failed to accurately reflect the assessment of fall risk completed on this patient. During an interview on 6/13/2022 at 12:09 PM, when queried why the OASIS start of care/comprehensive assessment section M0104 was incomplete, registered nurse B indicated it should have been completed, and was not sure how that section was skipped. When queried why the OASIS start of care/comprehensive assessment indicated a standardized fall assessment was not completed, administrator/clinical manager A indicated it was an error in charting. When queried why the OASIS start of care/comprehensive assessment indicated patient was not incontinent but the fall risk assessment indicated incontinence, administrator/clinical manager A indicated it was probably an error in charting. 3. Observation of a home visit for patient #3 was conducted on 6/10/2022 at 8:45 AM to observe a routine home health aide visit. The patient lived in city F. Patient #3 indicated the correct zip code was for city F. Clinical record review for patient #3 was completed on 6/13/2022 for certification period 4/13/2022 – 6/11/2022. Record review evidenced a start of care/comprehensive assessment dated 4/13/2022 which indicated the patient lived in city G. This document contained a section titled “M0060 Patient ZIP code” which indicated the patient’s zip code was for city H. During an interview on 6/13/2022 at 12:40 PM, administrator/clinical manager A indicated the address and zip code on the comprehensive assessment was incorrect and would need to be corrected. 4. Clinical record review for patient #4 was completed on 6/13/2022 for certification period 4/22/2022 – 6/20/2022. Record review evidenced an OASIS recertification/comprehensive re-assessment dated 4/19/2022 which indicated patient had intermittent pain to lower extremities which medication improved. This document contained a section titled “[M1242] Frequency of Pain Interfering with patient’s activity or movement” which stated, “… 0 – Patient has no pain ….” During an interview on 6/13/2022 at 3:01 PM, when queried if OASIS assessment of pain on recertification was accurate, administrator/clinical manager A indicated the nurse probably misinterpreted the question and thought it meant is the patient currently having any pain. 5. Clinical record review for patient #6 was completed on 6/13/2022 for certification period 10/10/2021 – 12/8/2021. Record review evidenced an OASIS transfer document dated 12/4/2021 which stated, “… [M2016] Patient/Caregiver Drug Education Intervention: … NA – Patient not taking any drugs ….” Record review evidenced a medication list dated 12/6/2021 which indicated the patient was taking the following medications: loperamide (for diarrhea), senna-docusate (for constipation), midodrine (for low blood pressure), albuterol (for wheezing), Apixaban (blood thinner), Keppra (for seizures), pregabalin (for nerve pain), trazadone (anti-psychotic/for sleep), and Auryxia (to lower phosphorus levels). Record review evidenced an OASIS discharge document dated 12/6/2021, which stated, “… [M2410] To which Inpatient Facility has the patient been admitted? … NA – No inpatient facility admission … Comments: went into hospital ….” During an interview on 6/13/2022 at 3:54 PM, when queried why the OASIS transfer document stated patient was not taking any drugs, administrator/clinical manager A indicated it was not accurate and must have been an error. At 4:00 PM, when queried why the OASIS discharge document indicated the patient was not admitted to an inpatient facility, when he was admitted to the hospital, administrator/clinical manager A indicated it was a mistake on their part. 6. Clinical record review for patient #7 was completed on 6/13/2022 for certification period 1/22/2022 – 3/22/2022. Record review evidenced an OASIS recertification/comprehensive re-assessment dated 1/20/2022 which included a section titled “[M1033] Risk for Hospitalization: Which of the following signs or symptoms characterize this patient as at risk for hospitalization [Mark all that apply] ….” This document failed to mark the option which indicated the patient had a history of falls or reported exhaustion. Clinical record review evidenced a patient communication note dated 1/20/2022 which indicated the patient fell during the skilled nurse visit this day, and stated, “… the patient has an increase in weakness … The patient stated he feels weak, not sleeping well at night ….” During an interview on 6/13/2022 at 4:09 PM, when queried why the OASIS recertification did not include exhaustion or falling as risk factors for hospitalization, administrator/clinical manager A indicated they should have been included.

G0528

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 record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health status in 4 of 7 clinical records reviewed. (#2, 4, 5, 6) The findings include: 1. Record review on 6/14/2022 evidenced an agency policy updated 6/10/2021, titled “Comprehensive Assessment of Patients [OASIS]” which stated, “… Components of a comprehensive assessment include … Head to Toe assessment … Integumentary status … Elimination status ….” 2. Clinical record review for patient #2 was completed on 6/13/2022 for certification period 4/14/2022 – 6/12/2022. Record review evidenced a start of care/comprehensive assessment dated 4/14/2022, which indicated the patient had a urinary catheter but failed to specify if it was a suprapubic catheter (tube inserted directly into the bladder to drain urine) or Foley catheter (tube inserted into the urethra to drain urine). This document failed to include an assessment of the catheter, including size, site assessment, or type of device. This document indicated patient had 2 wounds to left and right lower legs but failed to include measurements or any site assessment including color, drainage, or odor. During an interview on 6/13/2022 at 12:10 PM, administrator/clinical manager A indicated a full catheter site assessment should include what type of catheter, size, color of urine, and amount of output. Administrator/clinical manager A indicated a full wound assessment included measurements, color, drainage, and if any odor was present. Administrator/clinical manager A indicated wounds should be measured every visit. 3. Clinical record review for patient #4 was completed on 6/13/2022, for certification period 5/13/2022 – 7/11/2022. Record review evidenced a recertification/comprehensive re-assessment dated 5/9/2022 which indicated the patient had a left heel wound. This document failed to include a wound assessment including wound type, measurement, color, or type of dressing applied. The comprehensive re-assessment failed to include an assessment of patient’s suprapubic catheter (a tube inserted directly into the bladder to drain urine) site including size, insertion date, indication, site assessment, or dressing applied. During an interview on 6/13/2022 at 2:25 PM, when queried when wounds should be measured and documented on, administrator/clinical manager A indicated every visit wounds should be measured. Registered nurse B indicated wounds should be measured when dressing was changed, but did not include measurements for patient #4’s wound because it was less than a centimeter. When queried what wound documentation should include, registered nurse B indicated the type of dressing, drainage amount, odor, and color. At 2:27 PM, registered nurse B stated, when queried what type of sterile dressing was applied to patient #4’s left heel wound, “… a sterile 2x2 gauze dressing. Why is it sterile, because that’s me, he didn’t order it ….” At 2:35 PM, when queried what should be included in a full assessment of a suprapubic catheter, registered nurse B indicated it should include a site assessment, type of dressing applied, urine color and output. 4. Clinical record review for patient #5 was completed on 6/13/2022, for certification period 4/22/2022 – 6/20/2022. Record review evidenced a comprehensive re-assessment/recertification dated 4/22/2022, which indicated patient had a peg tube (tube inserted into stomach for feedings) and a tracheostomy (tube inserted into airway to assist with breathing), but failed to include a site assessment of tracheostomy or peg tube, including size, dressings to be applied, skin condition, or any other information. During an interview on 6/13/2022 at 3:05 PM, when queried what should be included on the comprehensive assessment regarding peg/tracheostomy, administrator/clinical manager A indicated it should have included type of dressing, if there was an inner cannula, how often it’s changed, color of drainage or sputum, size, and an assessment of the skin around the site. 5. Clinical record review for patient #6 was completed on 6/13/2022 for certification period 10/10/2021 – 12/8/2021. Record review evidenced a comprehensive re-assessment/recertification dated 10/6/2021, which included a wound graph which indicated patient had a dialysis catheter (central venous access site) to right chest. This same document indicated the patient had an arteriovenous graft/fistula site instead of a central venous catheter access site. This document failed to document any assessment of the dialysis access site, and failed to accurately reflect the specific type of dialysis access. During an interview on 6/13/2022 at 3:40 PM, when queried what a comprehensive assessment should include regarding dialysis access, administrator/clinical manager A indicated the assessment should have included the type of access, size, location, if the patient has a graft or a shunt, and the status of the dressing. Administrator/clinical manager A did not know if this patient had an arteriovenous graft/fistula or a central access dialysis catheter. 410 IAC 17-14-1(a)(1)(B)

G0536

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to review all medications patients were taking to identify significant drug interactions, duplicative drug therapy, and/or noncompliance with drug therapy in 4 of 5 active clinical records reviewed. (#1, 3, 4, 5) The findings include: 1. Record review on 6/14/2022, evidenced an agency policy updated 6/10/2022, titled “Medication Profile”, which stated, “… Nursing staff check all drug therapy a patient may be taking to identify … actual or potential interactions, side effects … duplicate drug therapy … and promptly report any problems to the physician ….” 2. Record review on 6/14/2022, evidenced an agency policy updated 6/10/2022, titled “Adverse Drug Reactions”, which stated, “… drug to drug reactions listed as potentially moderate or severe are reported to the prescribing physician prior to administration ….” 3. Observation of a home visit for patient #1 was conducted on 6/8/2022, at 8:00 AM, to observe a routine home health aide (HHA) visit. During the visit, the patient’s medication list was reviewed. The medication list included the following medications: Aspirin-Dipyridamole (medication to prevent platelets from sticking together), Aspirin (to prevent heart attack and stroke), Simvastatin (to lower cholesterol), Lisinopril (to lower blood pressure), hydralazine (to lower blood pressure), and metformin (to lower blood sugar). Clinical record review for patient #1 was completed on 6/13/2022, for certification period 4/12/2022 – 6/10/2022. Record review evidenced a document titled “Patient Medication Record” dated and electronically signed on 6/7/2022, which stated, “… Physician notified of severe medication interactions? … NA (no interactions) ….” Review on 6/13/2022 of a web-based reference, https://www.drugs.com/interactions-check.php, evidenced evidenced duplicative drug therapy between aspirin and aspirin-dipyridamole. 4. Observation of a home visit for patient #3 was conducted on 6/10/2022, at 8:45 AM, to observe a routine home health aide visit. During the visit, the patient’s medications were reviewed. Patient #3 indicated they were only taking Amaryl (to lower blood sugar) 2 times per week, instead of daily as ordered. Clinical record review for patient #3 was completed on 6/13/2022, for certification period 4/13/2022 – 6/11/2022. Record review evidenced a medication list dated 4/21/2022, which included the following medications: Baclofen (to treat muscle spasms), Amaryl (to lower blood sugar), Ibuprofen (for pain), and Clobetasol (steroid to decrease inflammation). This document stated, “… All medications the patient is currently using have been reviewed for … noncompliance with drug therapy ….” During an interview on 6/13/2022 at 1:00 PM, administrator/clinical manager A indicated the medication review should have address patient’s noncompliance with Amaryl. 5. Clinical record review for patient #4 was completed on 6/13/2022, for certification period 5/13/2022 – 7/11/2022. Record review evidenced a medication list dated 5/8/2022, which included the following medications: Levaquin (antibiotic), doxycycline (antibiotic), emergenC (vitamin C), Oxybutynin (for bladder spasms), baclofen (muscle relaxer), Megestrol Acetate (to increase appetite), Klonopin (anti-anxiety), and Desitin (diaper rash cream). This document stated, “… All medications the patient is currently using have been reviewed for … duplicate drug therapy….” This document included a duplicate order for Oxybutynin. During an interview on 6/13/2022 at 2:40 PM, when queried why Oxybutynin was included twice on the medication list, registered nurse B indicated it was accidentally entered twice and needs to be corrected. 6. Clinical record review for patient #5 was completed on 6/13/2022 for certification period 4/22/2022 – 6/20/2022. Record review evidenced a medication list dated 4/19/2022 which included but was not limited to the following medications: Potassium Chloride (electrolyte), Topamax (anti-seizures), and Robinul (to decrease respiratory secretions). This document stated, “… Physician notified of severe medication interactions? … NA [No interactions] ….” Review on 6/13/2022 of a web-based reference, https://www.drugs.com/interactions-check.php, evidenced 2 major drug-to-drug interactions between the following medications: potassium chloride and Robinul and Robinul and Topamax. 7. During an interview on 6/13/2022 at 10:55 AM, when queried why the medication reviews all say no interactions, registered nurse B stated, “… when I put the meds [medications] in, it will tell me if there are any drug interactions … I don’t notify the physician unless they have an adverse reaction or have new medications ....” Administrator/clinical manager A indicated the medication review should identify the major drug-to-drug interactions, duplicative drug therapy, and non-compliance with drug therapy. 410 IAC 17-14-1(a)(1)(B)

G0538

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the comprehensive assessment included the patient’s primary caregiver or other available supports including their willingness/ability to provide care and availability/schedules in 1 of 3 home visits conducted. (#2) The findings include: Record review on 6/14/2022 evidenced an agency policy updated 6/10/2021, titled “Comprehensive Assessment of Patients [OASIS]” which stated, “… Components of a comprehensive assessment include, but is not limited to: … Identification of an emergency contact … Availability and capability of caregivers ….” Observation of a home visit for patient #2 was conducted on 6/9/2022 at 2:00 PM to observe a routine skilled nurse visit. During the home visit, it was noted that the patient lived in a group home, and registered nurse B indicated the group home staff prepare all meals and assist patient with incontinent care or other needs. Clinical record review for patient #2 was completed on 6/13/2022 for certification period 4/14/2022 – 6/12/2022. Record review evidenced a start of care/comprehensive assessment dated 4/14/2022, which failed to include available group home supports, including their willingness and ability to provide care and availability. This document indicated patient received assistance from “family/friends” for activities of daily living, psychosocial support, assistance with medical appointments, delivery of medications and management of finances, but failed to specify names, availability, or capability of these family/friends to assist. During an interview on 6/13/2022 at 12:09 PM, when queried who patient #2’s caregiver/emergency contact was, registered nurse B indicated the patient did not have an emergency contact but lived in the group home. Administrator/clinical manager A indicated the caregiver should be included on the comprehensive assessment.

G0544

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to update and revise the comprehensive assessment due to a major decline in the patient's health status in for 2 of 2 patients who experienced a decline in health status. (#4, 6) The findings include: 1. Record review on 6/14/2022 evidenced an agency policy updated 6/10/2021, titled “Comprehensive Assessment of Patients [OASIS]” which stated, “… A comprehensive assessment incorporating the Outcomes and Assessment Information Set [OASIS] utilizing the most current approved version will be performed on qualified patients at: … When the patient’s condition warrants due to major decline or major improvement … A follow-up OASIS assessment will also be used to collect information as frequently as the condition of the patient warrants due to an unexpected major decline or improvement in the patient’s health status ….” 2. Clinical record review for patient #4 was completed on 6/13/2022 for certification periods 3/14/2022 - 5/12/2022 and 5/13/2022 – 7/11/2022. Record review evidenced a recertification/comprehensive re-assessment completed 3/11/2022, which indicated patient did not have any wounds. Review of a skilled nurse visit dated 4/28/2022 indicated patient had developed a left heel wound. Record review evidenced a skilled nurse visit note dated 5/6/2022, which stated, “… Dressing to left heel removed … Small amount of drainage noted … Wound decreasing in size … Wound was cleaned and sterile dressing applied ….” Record review failed to accurately document when onset of left heel wound occurred. Record review failed to evidence the home health agency performed a comprehensive re-assessment of patient due to significant change in condition/development of new wound. During an interview on 6/13/2022 at 2:28 PM, when queried what the agency considers a significant change in condition, registered nurse B stated, “… any change in vital signs, mental status, pain level … Any change in output or bowel movements ….” When queried when the agency performs re-assessments, administrator/clinical manager A stated, “… if there’s a change in status … patient is hospitalized … we send a nurse out to do another comprehensive assessment ….” Administrator/clinical manager A indicated a comprehensive re-assessment should have been completed for a patient who developed a new wound. 3. Clinical record review for patient #6 was completed on 6/13/2022 for certification period 10/10/2021 – 12/8/2021. Review of a comprehensive re-assessment/recertification dated 10/6/2021 indicated patient was alert and oriented, with a history of lung disease and high blood pressure, wore oxygen at 3 liters per minute at night, was on dialysis (artificial kidney filtration), and a 1500 milliliter fluid restriction. The blood pressure measurement on 10/6/2021 was 96/61, and the oxygen was 90% on room air. Clinical record review evidenced a skilled nurse visit note dated 11/23/2022 which indicated the patient’s blood pressure was 169/118. This document stated, “… Noted oxygen level at 77 % when oximeter first placed on finger … Instructed patient to put his oxygen on, 02 saturation increased to 85 – 90% with 02 on. Instructed patient to keep his oxygen on the rest of the day and check his saturation with his portable oxygen sensor. Oxygen in use at 3LPM [liters per minute] at night ….” Record review evidenced patient was hospitalized on 12/4/2022 for hypervolemia (fluid overload), weakness, hypoxia (low oxygen saturation), and high blood pressure. Record review failed to evidence a comprehensive re-assessment was completed due to a change in condition. During an interview on 6/13/2022 at 3:50 PM, administrator/clinical manager A stated, “… yes that was a status change … I would have the home health aide take vitals and send a nurse out to do a PRN [as needed visit] or another assessment ….” 410 IAC 17-14-1(a)(1)(B)

G0564

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the discharge summary included all information pertinent to patient’s current course of illness and treatment, post-discharge goals of care and treatment preferences in 2 of 2 discharge records reviewed. (#6, 7) The findings include: 1. Record review on 6/14/2022 evidenced an agency policy updated 6/10/2021, titled “Discharge/Transfer from Service” which stated, “… Upon transfer, the physician will receive via fax a transfer summary or discharge summary … containing at least the following: … diagnosis related to transfer … summary of care … care coordination … Discharge summary is written and in the chart. Include the patient’s health status at discharge and a summary of activities for each discipline, which served the patient ….” 2. Clinical record review for patient #6 was completed on 6/13/2022 for certification period 10/10/2021 – 12/8/2021, discharged 12/6/2021. Record review evidenced a comprehensive assessment dated 10/6/2021, which included the following diagnoses: hypertension (high blood pressure), end stage renal disease (kidney failure requiring artificial kidney filtration), and chronic obstructive pulmonary disease (a chronic lung disease which leads to low oxygen levels). This document indicated the patient used 3 liters of oxygen at night, received dialysis 3 times weekly, was on a 1500 milliliter fluid restriction, and was taking 5 or more medications. Clinical record review evidenced a discharge summary dated 12/6/2021 which failed to include any diagnoses, medical requirements such as dialysis requirements, nutritional information, oxygen use, or dialysis access type. This document failed to include any post-discharge goals of care or treatment preferences. During an interview on 6/13/2022 at 3:56 PM, administrator/clinical manager A indicated the discharge summary should have included information like oxygen use, dialysis access, nutritional requirements, and diagnoses. 3. Clinical record review for patient #7 was completed on 6/13/2022. Record review evidenced a plan of care for certification period 1/22/2022 – 3/22/2022 which indicated the patient had diagnoses of Parkinson’s disease, dementia, falls, high blood pressure, weakness, and constipation. Record review evidenced a discharge summary dated 3/22/2022 which indicated the patient was discharged per patient/family request, but failed to include post-discharge goals of care, diagnoses, or treatment preferences. During an interview on 6/13/2022 at 3:55 PM, when queried what information should be included in a discharge summary, administrator/clinical manager A stated, “… the reason for discharge … goals that were met … any necessary medical information and a medication list ….”

G0570

G0572

G0574

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 agency failed to ensure the plan of care included all medications, diagnoses, type and frequency of services, measurable goals and outcomes, interventions to address underlying risk factors for hospitalization, medical equipment and patient-specific interventions and goals for their patients in 7 of 7 clinical records reviewed. (#1, 2, 3, 4, 5, 6, 7) The findings include: 1. Record review on 6/13/2022 evidenced an agency policy updated 6/10/2022, titled “Care Planning” which stated, “… The plan of care, developed in accordance with the referring physician’s orders, may include, but not limited to: … Principle diagnosis and other pertinent diagnoses … Medications: dose/frequency/route … Orders for therapy services, include specific procedures and modalities to be used … safety measures … Problems/needs, interventions, treatments/orders, instructions, if any, to patient/patient representative and/or family ….” 2. Observation of a home visit for patient #1 was conducted on 6/8/2022, at 8:00 AM, to observe a routine HHA (home health aide) visit. During the visit, person A (family member) indicated the patient had diagnoses of prostate cancer, diabetes, and arthritis. Person A indicated they check patient #1’s blood sugar at least 1 time per day, and indicated the patient sees a urinary specialist for the prostate cancer. Patient #1 indicated he was getting physical therapy, but the last physical therapy visit was 5/1/2022. Clinical record review for patient #1 was completed on 6/13/2022, for certification period 4/12/2022 – 6/10/2022. Review evidenced a comprehensive assessment/recertification dated 4/8/2022, which indicated patient was taking Tylenol for arthritis pain to his lower back. Clinical record review on 6/13/2022, evidenced a face to face document dated 3/2/2022, which listed diagnoses of diabetes (problem regulating blood sugar), prostate cancer, and high cholesterol. Clinical record review evidenced a plan of care for certification period 04/12/2022 – 6/10/2022, which failed to evidence Tylenol in the medication list. This document stated, “… Patient’s mobility will be improved with assistance of physical therapist ….” The plan of care failed to include frequency or duration of physical therapy visits, or any therapy interventions. Record review failed to evidence a physical therapy plan of care. This document failed to include pertinent diagnoses of prostate cancer, arthritis, diabetes, and high cholesterol. During an interview on 6/13/2022 at 11:05 AM, when queried why the plan of care did not include diagnosis of arthritis, prostate cancer, high cholesterol, or diabetes, registered nurse B indicated they were not aware patient had a diagnosis of prostate cancer. Administrator/clinical manager A indicated they use the history and physical to add diagnoses to the plan of care, and all pertinent diagnosis should be added to the plan of care. At 11:08 AM, registered nurse B indicated she was not sure how frequently physical therapy was seeing patient #1, or when his last therapy session was. Administrator/clinical manager A indicated the plan of care should include the agency providing therapy services along with the frequency and duration of treatments, and a copy of the therapy care plan. At 1:05 PM, administrator/clinical manager A indicated the plan of care should include all medications the patient was taking. 3. Observation of a home visit for patient #2 was conducted on 6/9/2022 at 2:00 PM, to observe a routine skilled nurse visit. During the visit, the patient was observed to have a grabber, cane, and a trapeze bar (a bar the patient uses to assist with positioning in bed). The following medication bottles were observed, but not limited to: diazepam (anti-anxiety medicine) 5mg (milligrams) orally daily as needed for dizziness (prescription dated 5/17/2022), and doxazosin (medicine for high blood pressure) mesylate 1mg orally twice a day (prescription dated 5/25/2022). Patient #2 indicated he was taking Tylenol for aching pain to his knee and feet. Clinical record review for patient #2 was completed on 6/13/2022, for certification period 4/14/2022 – 6/12/2022. Record review evidenced a start of care/comprehensive assessment dated 4/14/2022, which included but was not limited to the following diagnoses: heart failure, chronic kidney disease, urinary incontinence, and cerebral infarction (lack of blood flow to the brain/stroke). This document indicated the patient had a wound to his right leg and left leg. This document indicated the patient was a risk for falling and had 3 + pitting edema (swelling which when pressed, demonstrates an indentation in the skin of 5 – 6 millimeters, which lasts for 60 seconds) to bilateral lower extremities. This document indicated the patient had an indwelling urinary catheter (tube inserted in urethra which allows urine to drain). Clinical record review evidenced a plan of care for certification period 4/14/2022 – 6/12/2022, which failed to be individualized to include any patient-specific interventions and/or goals addressing risk for falls, diagnoses of heart failure, chronic kidney disease, edema, wounds, or cerebral infarction. Plan of care failed to evidence any wound measurement orders or treatment for the wounds. This document stated, “… Goals and Outcomes … Patient will be free of skin breakdown during this episode of care ….” This document failed to be individualized to include any patient-specific interventions and/or goals related to care of an indwelling urinary catheter. This document failed to include a grabber, cane or trapeze bar in the DME (durable medical equipment section. The plan of care failed to include diazepam, doxazosin, and Tylenol on the medication list. Clinical record review evidenced a face-to-face document dated 4/7/2022, which included but was not limited to the following diagnoses, which were not included on the plan of care: hypertension (high blood pressure), left sided weakness, and left foot drop (difficulty lifting the front of foot). During an interview on 6/13/2022 at 11:53 AM, administrator/clinical manager A indicated the plan of care should have included diagnoses of hypertension, left sided weakness, and left foot drop. When queried what DME (durable medical equipment) should be included on the plan of care, administrator/clinical manager A indicated all durable medical equipment should be included. Administrator/clinical manager A indicated the plan of care should include all medications the patient was taking. During an interview on 6/13/2022 at 12:06 PM, when queried how patient #2’s plan of care should have been individualized, and which patient-specific interventions/education it should have included, registered nurse B indicated it should have included education regarding slow transfers, ensuring all obstructions are cleared, instruction to use assistive devices to ambulate, assessing for swelling, diet education, monitoring blood pressure and urine output, foley care instructions. When queried how the goal of being free of skin breakdown was patient-specific and measurable, if patient #2 already had wounds upon start of care, registered nurse B stated, “… they aren’t wounds to me, so I would just take the wounds off for the next visit … I shouldn’t have put them on there as a wound ….” When queried what a wound was, registered nurse B stated, “… I consider a wound something that’s open, draining … I don’t think that it’s a wound so to speak ….” 4. Observation of a home visit for patient #3 was conducted on 6/10/2022, at 8:45 AM, to observe a routine home health aide visit. During the visit, the patient’s medications were reviewed. Patient #3 indicated they were taking Eliquis (blood thinner) for a blood clot, which was not included on the plan of care. Patient #3 indicated they had never taken Lasix (water pill) or a multivitamin. Clinical record review for patient #3 was completed on 6/13/2022, for certification period 4/13/2022 – 6/11/2022. Record review evidenced a start of care/comprehensive assessment dated 4/13/2022, which indicated the patient was a fall risk. This document included, but was not limited to the following diagnoses: multiple sclerosis (a disease in which nerve damage impairs the communication between the brain and the body), edema (swelling), chronic kidney disease, and diabetes (a problem regulating blood sugars). The comprehensive assessment indicated patient #3 had 5/10 pain to lower back which interfered with patient’s activity or movement daily. This document stated, “… evidence of cellulitis rt. [right] lower extremity ….” Clinical record review evidenced a plan of care for certification period 4/13/2022 – 6/11/2022. This document indicated the patient had the following risks for hospitalization: difficulty complying with medical instructions in the past 3 months and currently reports exhaustion. This document failed to include interventions to address these underlying risk factors such as education on medical instructions or energy conserving techniques. The plan of care failed to be individualized to include patient-specific interventions/education and/or measurable outcomes and goals to address cellulitis, fall risk status, diabetes, edema, multiple sclerosis, pain, or chronic kidney disease. This document included the following medications: Baclofen (muscle relaxer), Amaryl (to lower blood sugar), Ibuprofen (for pain), multivitamin, and Lasix. The plan of care failed to include the Eliquis patient was taking, or the diagnosis of blood clot. During an interview on 6/13/2022 at 12:44 PM, registered nurse B indicated interventions to address patient #3's risk factors for hospitalization would be education about quitting smoking. Administrator/clinical manager A indicated there were no interventions to address the underlying risk factors for hospitalization on patient #3’s plan of care. Administrator/clinical manager A indicated the plan of care does not include any patient-specific interventions/education or goals related to the patient’s diagnoses or risk factors, but they would add patient-specific interventions in the future. At 12:53 PM, registered nurse B stated, when asked what patient-specific interventions should be included on patient #3’s plan of care, “… for pain management, see what relieves the pain, non-pharmacological measures for pain, what makes pain worse … If medication relieves pain, follow-up on medication ….” At 12:56 PM, when queried which patient-specific interventions/education the plan of care should include for a diabetic patient, registered nurse B indicated it should include diet education, instruction on medications, foot care, and assessing the patient’s knowledge of blood sugar measurements. At 1:05 PM, when queried which medications the plan of care should include, administrator/clinical manager A indicated it should include all the medications the patient was taking. When queried why patient #3’s medication list on the plan of care was not accurate, administrator/clinical manager A indicated they did not know since it should auto-populate from the comprehensive assessment medication reconciliation. 5. Clinical record review for patient #4 was completed on 6/13/2022, for certification period 5/13/2022 – 7/11/2022. Record review evidenced a plan of care dated 5/9/2022, which included the following medications: Levaquin (antibiotic), doxycycline (antibiotic), emergenC (vitamin C), Oxybutynin (for bladder spasms), baclofen (muscle relaxer), Megestrol Acetate (to increase appetite), Klonopin (anti-anxiety), and Desitin (diaper rash cream). The plan of care included but was not limited to the following diagnosis: quadriplegia (paralysis from the neck down), neurogenic bowel (loss of normal bowel function), and neuromuscular dysfunction of bladder (loss of normal bladder function). This document stated, “… Goals and Outcomes … Patient skin integrity will remain intact during this episode ….” Clinical record review evidenced a medication list which stated, “… Doxycycline … daily x 5 days … start date: 1/6/2022 ….” Record review failed to evidence the plan of care included all current medications patient was taking. Clinical record review evidenced a comprehensive re-assessment/recertification dated 5/9/2022, which indicated the patient had a wound to the left heel. Clinical record review evidenced a history and physical dated 10/5/2021, which included a diagnosis of depression which was not included on the plan of care. During an interview on 6/13/2022 at 2:41 PM, when queried why depression was not included on the plan of care, administrator/clinical manager A indicated they needed to add it, it probably didn’t get added since the patient had been on service for several years. At 2:42 PM, when queried why the plan of care included a medication which was supposed to be taken only for 5 days in January, registered nurse B indicated they didn’t put the discontinue date in. At 2:52 Pm, when queried how the goal of skin remaining intact was measurable if patient already had a wound, administrator/clinical manager A indicated it was not measurable and needed to be updated. 6. Clinical record review for patient #5 was completed on 6/13/2022, for certification period 4/22/2022 – 6/20/2022. Record review evidenced a plan of care dated 4/19/2022, which indicated the patient was receiving tube feeding Osmolite 1000 cubic centimeters per day via a feeding pump continuously, but failed to evidence the rate of tube feeding or flush frequency or amount. The plan of care included but was not limited to the following medication orders: wound wash cleanse affected area as ordered and PRN (as needed), Santyl (wound treatment to remove dead tissue from wound bed) apply ointment to affected area as ordered and PRN, Pepto-Bismol every 4-6 hours PRN, Robitussin (cough medicine) every 4-6 hours PRN, Normal Saline Flush Intravenous (through the vein) inhale via trach (a tube inserted in the airway to help with breathing) PRN, Desitin apply topically to peri area PRN, Triamcinolone Acetonide (medicine to decrease irritation to skin) apply topically to peri area PRN, A & D Zinc Oxide apply topically to affected peri area PRN, Bacitracin (antibiotic) apply topically to affected areas PRN, Hydrocortisone Acetate (steroid cream) apply topically PRN, Ketoconazole (antifungal cream) apply topically PRN, Flonase Allergy Relief 1 spray in each nostril PRN, Artificial tear solution place 1 drop in both eyes every 6 hours PRN, Dulcolax (laxative) rectally daily PRN, and vitamin D 1 tab crushed via feeding tube. The plan of care failed to include indications for PRN medication, failed to include location to apply topical medication, and failed to include frequency of vitamin D. Plan of care failed to include Hoyer lift under durable medical equipment. Clinical record review evidenced a nursing flow sheet shift assessment dated 4/24/2022, which stated, “… Diaper changed, up to w/c [wheelchair] with Hoyer lift ….” Clinical record review evidenced a comprehensive re-assessment/recertification dated 4/22/2022, which indicated patient did not have any wounds to apply wound cleanser or Santyl to. Plan of care failed to be individualized to include only medications pertinent to patient. During an interview on 6/13/2022 at 3:11 PM, when queried if the plan of care should include rate of tube feeding in nutritional requirements, administrator/clinical manager A indicated the plan of care should include the rate and flush amount. During an interview on 6/13/2022 at 3:13 PM, registered nurse B indicated patient #5 did not have a wound. When queried why Santyl was ordered on the plan of care, administrator/clinical manager A indicated it was probably an old order from a previous certification period. At 3:15 PM, when queried what should be included in a complete medication order on the plan of care, administrator/clinical manager A indicated an indication for PRN medications, frequency of administration, and location for topicals to be applied. At 3:18 PM, when queried if a Hoyer lift should be included on the plan of care under durable medical equipment, administrator/clinical manager A indicated it should be included. 7. Clinical record review for patient #6 was completed on 6/13/2022 for certification period 10/10/2021 – 12/8/2021. Record review evidenced a plan of care dated 10/13/2021, for certification period 10/10/2021 – 12/8/2021, which failed to be individualized to include patient-specific interventions/orders/education, or measurable outcomes/goals related to patient’s oxygen use, hypertension (high blood pressure), end stage renal disease requiring dialysis (kidney failure requiring blood filtration), and/or chronic obstructive pulmonary disorder (COPD/type of chronic lung disease). This document indicated patient had the following risk factors for hospitalization or emergency visits: history of difficulty complying with medical instructions in the last 3 months and currently taking 5 or more medications. This document failed to include all necessary interventions to address the risk factors for hospitalization or emergency room visits. During an interview on 6/13/2022 at 3:37 PM, when queried how this patient’s plan of care should have been individualized for his diagnosis and risk factors, administrator/clinical manager A indicated it should have included information/education on oxygen use such as rate of oxygen flow, if the patient uses a cannula or mask, education not to smoke, and education on storage of oxygen. Administrator/clinical manager A indicated patient #6’s plan of care should have been individualized to include patient-specific interventions such as monitoring intake and output, monitoring blood pressure, diet compliance education, and assessing the extremities for edema. 8. Clinical record review for patient #7 was completed on 6/13/2022, for certification period 1/22/2022 – 3/22/2022. Record review evidenced a face-to-face document dated 8/31/2021, which included but was not limited to the following diagnoses as the primary reasons for home care: history of benign prostatic hyperplasia (prostate enlargement) and right shoulder osteoarthritis (arthritis of right shoulder). Clinical record review evidenced a recertification/comprehensive re-assessment dated 1/20/2022, which stated, “… [Family member] applies biofreeze [a pain relief topical medication]….” Clinical record review evidenced a plan of care for certification period 1/22/2022 – 3/22/2022, which indicated patient was taking Tamsulosin (medication for enlarged prostate), and Finasteride (medication for enlarged prostate), but failed to include diagnosis of benign prostatic hyperplasia. This document also failed to include the diagnosis of right shoulder osteoarthritis. This document failed to include interventions to address the patient’s risks for hospitalization including taking 5 or more medications, and a decline in mental, emotional, or behavioral status in the last 3 months. The plan of care failed to include Biofreeze on the medication list. During an interview on 6/13/2022 at 4:17 PM, when queried how the plan of care should address underlying risk factors for hospitalization, administrator/clinical manager A indicated it should include education on medication, reminding patient to use assistive devices, and caregiver education. When queried if the plan of care should include diagnoses of benign prostatic hyperplasia and osteoarthritis, administrator/clinical manager A indicated it should. When queried which medications should be included on the plan of care, administrator/clinical manager indicated all medications the patient was taking. When queried why biofreeze was not included, registered nurse B stated, “… yeah, the [family member] just said she applied it wherever to whatever hurts … so I didn’t know how to enter that in there [the plan of care] ….” 410 IAC 17-13-1(a)(1)(B) 410 IAC 17-13-1(a)(1)(C) 410 IAC 17-13-1(a)(1)(D)(ii, iii, ix, x, xi)

G0576

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patient care orders were recorded in the plan of care in 1 of 5 active clinical records reviewed. (#3) The findings include: Record review on 6/14/2022 evidenced an agency policy updated 6/10/2021, titled “Care Planning” which stated, “… The plan of care is based upon the physician’s orders and encompasses the equipment, supplies, disciplines, and services required to meet the patient’s needs ….” Clinical record review for patient #3 was completed on 6/13/2022, for certification period 4/13/2022 – 6/11/2022. Record review evidenced a face-to-face order signed by physician B on 4/26/2022, which stated, “… SN [skilled nursing] required to monitor vital signs, administer medications, and educate on disease process, fall/home safety, and importance of medications, side effects, and complications … PT/OT [physical therapy/occupational therapy] for assistance in improving strength, bed mobility, balance, transfer, and gait and to establish a home exercise program and increase of motion and home safety training ….” Clinical record review evidenced a plan of care for certification period 4/13/2022 – 6/11/2022 which failed to include skilled nursing orders for monitoring vital signs, administering medications, and educating on disease process, fall/home safety, and importance of medications, side effects and complications. This document failed to evidence any occupational therapy or physical therapy orders or referrals. During an interview on 6/13/2022 at 12:34 PM, administrator/clinical manager A indicated the agency was not aware of the skilled nursing or therapy orders, so did not include them on the plan of care. Registered nurse B indicated the patient’s physician’s office was providing skilled nursing for the patient, but did not know what services they were providing or how frequently they were seeing the patient. Administrator/clinical manager A indicated all orders should be recorded in the plan of care.

G0580

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 agency failed to ensure all services and treatments were administered only as ordered by a physician in 1 of 5 active clinical records reviewed. (#4) The findings include: Record review on 6/14/2022 evidenced an agency policy updated 6/10/2021, titled “Physician Orders/Plan of Care” which stated, “… The physician sets up a plan of care, which includes the diagnosis, prognosis, goals to be accomplished, and order for each service, item of drugs, and equipment to be provided by the Agency … Verbal orders may be received by the RN [registered nurse] … Verbal orders are put into writing, signed, and dated by the person receiving the order ….” Record review on 6/14/2022 evidenced an agency policy updated 6/10/201, titled “Wound Care Management” which stated, “… staff will obtain specific physician orders to perform wound care for Agency patients … Orders shall at a minimum contain the specific protocol, technique to be observed, supplies, frequency, duration and any adverse events to report to the physician … Agency RN [registered nurse] to perform/teach wound care as ordered by the physician ….” Clinical record review for patient #4 was completed on 6/13/2022 for certification periods 3/14/2022 - 5/12/2022 and 5/13/2022 – 7/11/2022. Record review evidenced skilled nurse visit notes for dates 5/6/2022, 5/16/2022, 5/20/2022, 5/26/2022, 6/3/2022, 6/7/2022, and 6/9/2022 which all stated, “… Dressing to left heel removed. Small amount of drainage noted. Wound decreasing in size. Wound was cleaned and sterile dressing applied ….” Record review failed to evidence physician orders for wound care, including type/frequency, of cleansing or dressing to be applied. During an interview on 6/13/2022 at 2:24 PM, when queried what the wound care orders were for patient #4, administrator/clinical manager A stated, “… we didn’t amend the plan of care … we need to say if there’s an order from the physician ….” Registered nurse B indicated the physician said to keep the wound clean, but didn’t specify any wound care orders, and no wound care orders were documented. 410 IAC 17-13-1(a)

G0590

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure they promptly alerted the physician to any change in patients’ condition in 5 of 7 clinical records reviewed. (#2, 3, 4, 6, 7) The findings include: 1. Record review on 6/14/2022, evidenced an agency policy updated 6/10/2021, titled “Coordination of Client Care” which stated, “… The agency staff: … Notifies the physician, patient and family and other staff of significant events or revisions in the plan ….” 2. Record review on 6/14/2022, evidenced an agency policy updated 6/10/2021, titled “Care Planning” which stated, “… Clinicians will inform the patient’s physician of any changes that suggest a need to alter the plan of care … If person-to-person contact was not completed or if awaiting a return response, all contacts and interactions shall be documented … All orders shall contain sufficient information to carry out the order, name of the physician, intermediate care provider and, if appropriate, representative conferring the order to the agency ….” 3. Clinical record review for patient #2 was completed on 6/13/2022, for certification period 4/14/2022 – 6/12/2022. Record review evidenced a skilled nurse visit noted dated 5/12/2022, which indicated the patient’s blood pressure was 135/100. This document stated, “… patient c/o [complains of] lightheadedness and dizziness … Physician was called to notify of the elevated BP [blood pressure] … I was referred to the NP [nurse practitioner] who was busy with patients and was unable to speak to her … message was left and the NP was to return call to patient ….” Record review failed to evidence which physician was contacted. Record review failed to evidence any physician or NP was made aware of elevated blood pressure, dizziness, and lightheadedness. Clinical record review evidenced a skilled nursing visit note dated 5/26/2022, which stated, “… Patient c/o lightheadedness and dizziness … Physician was called to notify of the elevated BP … I was referred to the NP who was busy with patients and was unable to speak to her … message was left and the NP was to return call to patient ….” During an interview on 6/13/2022, at 12:18 PM, when queried which physician was made aware of change in patient’s condition, lightheadedness, and dizziness on 5/12/2022 and 5/26/2022, administrator/clinical manager A indicated it was not documented. Registered nurse B indicated the office never called her back regarding the lightheadedness or dizziness, but the physician ordered the patient valium (anti-anxiety medication). Administrator/clinical manager A indicated when the physician is notified, it should be documented which physician was called, on what date, at what time, and what the notification was regarding. 4. Clinical record review for patient #3 was completed on 6/13/2022, for certification period 4/13/2022 – 6/11/2022. Record review evidenced a start of care/comprehensive assessment dated 4/13/2022, which stated, “… Evidence of cellulitis [an infection in the skin] rt. [right] lower extremity ….” Review failed to evidence physician notification of cellulitis, which could have indicated the need for a change in the plan of care. During an interview on 6/13/2022 at 1:00 PM, when queried if the physician was made aware of the cellulitis, registered nurse B indicated there was a nurse practitioner in the patient’s home during the comprehensive assessment who knew about the cellulitis, but did not document the name of the nurse practitioner or notify the patient’s physician. 5. Clinical record review for patient #4 was completed on 6/13/2022, for certification periods 3/14/2022 - 5/12/2022 and 5/13/2022 – 7/11/2022. Record review evidenced a recertification/comprehensive re-assessment completed 3/11/2022, which indicated patient did not have any wounds. Record review evidenced a skilled nurse visit note dated 5/6/2022, which stated, “… Dressing to left heel removed … Small amount of drainage noted … Wound decreasing in size … Wound was cleaned and sterile dressing applied ….” Record review failed to accurately document when onset of left heel wound occurred. Record review failed to evidence orders for wound care, or documentation the physician was notified of new wound to left heel, which suggested the plan of care should be revised. During an interview on 6/13/2022 at 2:24 PM, when queried if the physician was notified of the change in patient condition/new wound to left heel, registered nurse B stated, “… I called [physician C] and notified of new wound, and he just said to keep it clean … It was like a blister like thing, and when it comes off you have a little wound ….” Registered nurse B indicated the physician notification was not documented and could not recall the date of onset of wound, or date physician was notified. 6. Clinical record review for patient #6 was completed on 6/13/2022, for certification period 10/10/2021 – 12/8/2021. Review of a comprehensive re-assessment/recertification dated 10/6/2021, indicated patient was alert and oriented, with a history of lung disease and high blood pressure, wore oxygen at 3 liters per minute at night, was on dialysis (artificial kidney filtration), and a 1500 milliliter fluid restriction. The blood pressure measurement on this visit was 96/61, and the oxygen was 90% on room air. Clinical record review evidenced a skilled nurse visit note dated 11/23/2022, which indicated the patient’s blood pressure was 169/118. This document stated, “… Noted oxygen level at 77 % when oximeter first placed on finger … Instructed patient to put his oxygen on, 02 saturation increased to 85 – 90% with 02 on. Instructed patient to keep his oxygen on the rest of the day and check his saturation with his portable oxygen sensor. Oxygen in use at 3LPM [liters per minute] at night ….” Record review failed to evidence the physician was notified of the change in patient’s condition which suggested the plan of care may need to be altered. During an interview on 6/13/2022 at 3:50 PM, administrator/clinical manager A stated, “… yes that was a status change … I would have the home health aide take vitals and send a nurse out to do a PRN [as needed visit] or another assessment ….” Administrator/clinical manager A indicated the physician should have been notified of the change in patient’s status and abnormal vitals. 7. Clinical record review for patient #7 was completed on 6/13/2022 for certification period 1/22/2022 – 3/22/2022. Record review evidenced a patient communication note dated 1/20/2022 which stated, “… As he got to the doorway, lost his grip and we eased him to the floor … we stood him up and put him in the wheelchair … my administrator and patient’s [family member] were notified of the above I informed them that the patient has an increase in weakness ….” Review failed to evidence the physician was notified of patient’s fall on 1/20/2022. During an interview on 6/13/2022 at 4:03 PM, administrator/clinical manager A stated, “… we needed to notify the doctor for the fall ….” 410 IAC 17-13-1(a)(2)

G0606

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to integrate and coordinate services to assure the identification of patient needs or factors that could affect treatment effectiveness in 4 of 7 clinical records reviewed. (#1, 2, 4, 6) The findings include: 1. Record review on 6/13/2022, evidenced an agency policy updated 6/10/2021, titled “Coordination of Client Care” which stated, “… All service providers involved in the care of a client, including contracted health care professionals or another Agency, will be engaged in an effective interchange, reporting, and coordination of care regarding the client. All such coordination of care will be documented in the client record. Each client will be assessed upon admission as to identify any other agencies providing services to the client ….” 2. Observation of a home visit for patient #1 was conducted on 6/8/2022, at 8:00 AM, to observe a routine home health aide visit. Patient #1 was observed sitting in a wheelchair. The patient was able to stand, by holding on to the walker, and with assistance of the home health aide. Patient #1 indicated he had previously received physical therapy, and the last visit was 5/1/2022, but he would like to receive physical therapy to improve his ambulation. He indicated he was told by the therapist he couldn’t receive any more physical therapy visits until he went to his next doctor appointment. Clinical record review for patient #1 was completed on 6/13/2022, for certification period 4/12/2022 – 6/10/2022. Record review evidenced a plan of care for certification period 4/12/2022 – 6/10/2022, which stated, “… Patient’s mobility will be improved with assistance of physical therapist ….” Record review failed to evidence integration of physical therapy services to ensure coordination of care, failed to evidence the name of the physical therapy agency which provided services, and failed to evidence any communication between the therapy agency and the home health agency regarding frequency of visits or services to be provided. Record review failed to evidence the home health agency communicated with the physician regarding the patient’s therapy needs, or interruption of therapy services. During an interview on 6/13/2022 at 11:17 AM, when queried how the agency integrates physical therapy services and coordinates care, administrator/clinical manager A stated, “… we don’t have any care coordination on him yet ….” When queried how the agency is meeting this patient’s needs if he requires physical therapy, but therapy is not being provided, administrator/clinical manager A stated, “… we need to communicate with the doctor for new script or new order ….” 3. Observation of a home visit for patient #2 was conducted on 6/9/2022, at 2:00 PM, to observe a routine skilled nurse visit. During the visit, the patient was observed to have a urinary catheter (tube inserted into the bladder or urethra to drain urine). The registered nurse failed to assess the catheter during the home visit. Clinical record review for patient #2 was completed on 6/13/2022, for certification period 4/14/2022 – 6/12/2022. Record review evidenced a skilled nurse visit note dated 5/26/2022, which indicated the patient had a Foley catheter (tube inserted into the urethra to drain urine), which was last changed 4/11/2022. This document indicated the Foley catheter was changed by a physician, but failed to indicate which physician, at what intervals, or to evidence care coordination to ensure the patient’s catheter was changed at appropriate intervals. A plan of care was reviewed for certification period 4/14/2022 – 6/12/2022, which failed to evidence any care coordination note or instructions/orders regarding the patient’s Foley catheter. During an interview on 6/10/2022 at 1:43 PM, administrator/clinical manager A indicated several of the agency’s patients received only home health aide services, and another home health agency provided skilled nursing due to staffing issues with nurses. Administrator/clinical manager A indicated there was no agreement between the agencies sharing patients. When queried how the agency coordinates the patient’s care between agencies, administrator/clinical manager A indicated the agency completes a care coordination note every 30 days with the other agency. Registered nurse B did not know how frequently the Foley changes were ordered for patient #2. 4. Clinical record review for patient #4 was completed on 6/13/2022, for certification period 3/14/2022 – 5/12/2022. Record review evidenced a physician order dated and signed on 4/15/2022. This order stated, “… Request physical therapy evaluation for upper extremity strengthening and bilateral feet ROM [range of motion] ….” Record review failed to evidence a physical therapy evaluation was completed or coordinated. Record review failed to evidence communication between the home health agency and the therapy agency. During an interview on 6/13/2022 at 2:18 PM, when queried whether the physical therapy referral was completed, administrator/clinical manager A stated, “… we called [Entity D/physical therapy agency] and they needed the order directly from the physician, not us, so [registered nurse B] went directly to the physician’s office and let [physician C] know to send an order directly to [entity D] ….” When queried if the patient received physical therapy services, registered nurse B indicated the home health agency never received any information from the physical therapy agency and did not know if therapy saw patient #4 or evaluated the patient. 5. Clinical record review for patient #6 was completed on 6/13/2022 for certification period 10/10/2021 – 12/8/2021. Record review evidenced a comprehensive re-assessment/recertification dated 10/6/2021 which indicated patient was receiving skilled nursing services from agency D (home health agency). No care coordination or plan of care outlining what type and frequency of services agency D was providing was evidenced. Clinical record review evidenced a plan of care for certification period 10/10/2021 – 12/8/2021 ,which indicated patient was receiving skilled nurse visits every 15 days and a home health aide daily. During an interview on 6/10/2022 at 1:43 PM, when queried how some patients receive skilled nursing from 2 home health agencies, administrator/clinical manager A stated, “… we sometimes have patients who we provide HHA [home health aide] services to, since we didn’t have a nurse except for myself and registered nurse I … The other agency [home health] provides skilled nursing and we provide the aide, but don’t bill for duplicate services … We don’t have an agreement or anything … If the aide is in the home, and notices something, we call the doctor … and we do a care coordination note every 30 days with the other agency ….” Administrator/clinical manager A indicated, when queried why there was no care coordination note for patient #6, that most of the time the other home health agency doesn’t provide the information requested such as a plan of care or frequency of visits. 410 IAC 17-12-2(h)

G0640

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to: Based on record review and interview, the agency failed to measure, analyze and track quality indicators such as adverse patient events, and other aspects of performance which would enable the agency to assess processes of care, services and operations (see tag G642); utilize quality indicator data to monitor effectiveness and safety of services and quality of care and identify opportunities for improvement (see tag G644); focus on high-risk, high-volume, or problem-prone areas (see tag G648); ensure the performance improvement activities considered incidence, prevalence, and severity of problems (see tag G650); to ensure the performance improvement activities lead to an immediate correction of any identified problem that directly or potentially threatens the health and safety of patients (see tag G652); ensure the performance improvement activities analyzed the causes of adverse patient events and implemented preventive actions (see tag G654); measure the success of the performance improvement activities and track performance to ensure that improvements are sustained (see tag G656); and document and conduct a performance improvement project (see tag G658). This practice had the potential to affect all agency patients. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation 484: 65 Condition: Quality Assessment / Performance Improvement.

G0642

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to measure, analyze and track quality indicators such as adverse patient events, and other aspects of performance which would enable the agency to assess processes of care, services and operations. The findings include: Record review evidenced an agency policy updated 6/8/2022, titled “Quality Assessment & Performance Improvement Plan” which stated, “… The QAPI [quality assessment and performance improvement] committee will review at least the following: … Infection control activities and communicable diseases … Negative client care outcomes …Medication administration and errors … Adverse Drug Reactions … Outcome-Based Quality Monitoring … Outcome-Based Quality Improvement Report ….” Review of the agency’s QAPI program on 6/13/2022 evidenced a Quarterly Infection Log dated 6/9/2022, which indicated 2 urinary tract infections, and 1 patient with urinary tract infection was hospitalized on 6/8/2022. Record review failed to evidence any tracking or analysis of hospitalizations, falls, wounds, or other quality indicators. Clinical record review for patient #4 was completed on 6/13/2022. Record review evidenced the patient developed a new wound to left heel during certification period 3/14/2022 – 5/12/2022. Clinical record review for patient #6 was completed on 6/13/2022. Record review evidenced the patient was admitted to the hospital on 12/04/2021 for shortness of breath and hypervolemia (fluid overload). Clinical record review for patient #7 was completed on 6/13/2022. Record review indicated on 1/20/2022, during a home visit, the patient fell, and was assisted to the floor by home health staff and placed in the wheelchair. Record review on 6/13/2022 evidenced a document titled “Quality Assessment and Performance Improvement Committee Minutes of Member Meeting” dated December 2021, which stated, “… Negative Client Care Outcomes … None … Review of all incidents … None …” This document failed to measure, analyze, and track hospitalizations, including patient #6’s hospitalization. Record review on 6/13/2022 evidenced a document titled “Quality Assessment and Performance Improvement Committee Minutes of Member Meeting” dated March 2022, which stated, “… Negative Client Care Outcomes … None … Review of all incidents … None …” This document failed to measure, analyze, and track patient falls, to include patient #7’s fall. During an interview 6/13/2022 at 10:30 AM, administrator A stated, when queried which quality indicators the agency is tracking for QAPI, “… none right now …” Administrator A indicated the agency looks at hospitalizations due to infections but were more focused on documentation and updating OASIS. Registered nurse B indicated the agency did not consider patient #7 as a fall because they were assisted to the ground and did not track or analyze this fall. 410 IAC 17-12-2(a)

G0644

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to utilize quality indicator data to monitor effectiveness and safety of services and quality of care and identify opportunities for improvement. The findings include: Record review on 6/13/2022 evidenced an agency policy updated 6/8/2022, titled “Quality Assessment & Performance Improvement Plan” which stated, “… Assessment of these measures will be through data collection, which at a minimum will consist of clinical record review, patient interviews, and patient satisfaction reports … Each performance improvement activity/study includes the following items: … A description of indicator(s) to be monitored/activities to be conducted … Methods of data collection ….” Review on 6/13/2022 of the QAPI [Quality Assessment and Performance Improvement] program, failed to evidence any quality indicator data used to measure effectiveness and safety of services and quality of care to identify opportunities for improvement. During an interview on 6/13/2022 at 10:16 AM, when queried how the QAPI program utilizes data to measure effectiveness and safety of services, administrator A stated, “… I’ve not calculated the data … we are going to start using a program in Kinnser [electronic medical record] to calculate the data percentages straight out of the OASIS [Outcome and Assessment Information Set] program ... that’s our goal, I put in a few goals, and never followed it up ….” 410 IAC 17-12-2(a)

G0654

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the performance improvement activities analyzed the causes of adverse patient events and implemented preventive actions. The findings include: Record review on 6/13/2022 evidenced an agency policy updated 6/8/2022, titled “Quality Assessment & Performance Improvement Plan” which stated, “… The QAPI committee will review at least the following: … negative client care outcomes … Each performance improvement activity/study includes the following items: … A description of indicator(s) to be monitored/activities to be conducted … Methods of data collection … Acceptable limits for findings … Plans to re-evaluate if findings fail to meet acceptable limits ….” Review on 6/13/2022 of the agency’s QAPI program failed to evidence tracking or analysis of adverse patient events such as falls, hospitalization, and wounds in the performance improvement activities. Review failed to evidence the agency implemented any preventative actions or performance improvement activities. Review of the agency’s QAPI program on 6/13/2022 evidenced a Quarterly Infection Log dated 6/9/2022, which indicated 2 urinary tract infections, and 1 patient with urinary tract infection was hospitalized on 6/8/2022. Record review failed to evidence tracking of wounds, falls, or hospitalizations, and failed to evidence performance improvement activities which led to an immediate correction of any identified problems. Clinical record review for patient #4 was completed on 6/13/2022. Record review evidenced the patient developed a new wound to left heel during certification period 3/14/2022 – 5/12/2022. Clinical record review for patient #6 was completed on 6/13/2022. Record review evidenced the patient was admitted to the hospital on 12/04/2021 for shortness of breath and hypervolemia (fluid overload). Clinical record review for patient #7 was completed on 6/13/2022. Record review indicated on 1/20/2022, during a home visit, the patient fell, and was assisted to the floor by home health staff and placed in the wheelchair. During an interview on 6/13/2022 at 10:39 AM, when queried how the agency uses performance improvement activities to track, analyze, and implement preventative actions, administrator A indicated the agency had not implemented any performance improvement activities, and just started tracking infections. Administrator A indicated the agency did not have any wound, hospitalization, or fall tracking information currently. Administrator A indicated the agency discussed adverse events and determined contributing factors verbally. Administrator A stated, “… we would look at falls, like a patient not using assistive devices and ensuring aides are reminding patients to use their assistive devices and doing patient education ….” 410 IAC 17-12-2(a)

G0656

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to measure the success of the performance improvement activities and track performance to ensure that improvements were sustained. The findings include: Record review on 6/13/2022 evidenced an agency policy updated 6/8/2022, titled “Quality Assessment & Performance Improvement Plan” which stated, “… The following elements are considered within the plan: … Monitoring to determine effectiveness of the action … Documentation of the review of its own program … An agency must document corrective action to ensure that improvements are sustained over time ….” Review of the agency’s QAPI program on 6/13/2022, failed to evidence any performance improvement actions were implemented, and failed to evidence measurement or tracking of performance to ensure improvements were sustained. During an interview on 6/13/2022 at 10:40 AM, administrator A indicated because the agency had not implemented any performance improvement activities, they did not measure or track performance. 410 IAC 17-12-2(a)

G0658

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to conduct and document a performance improvement project. The findings include: Record review on 6/13/2022 evidenced an agency policy updated 6/8/2022, titled “Quality Assessment & Performance Improvement Plan” which stated, “… The annual QAPI report includes … Summary of all PI activities, findings, and corrective actions … Each performance improvement activity/study includes the following items: … A description of indicator(s) to be monitored/activities to be conducted … methods of data collection … Plans to re-evaluate if findings fail to meet acceptable limits in addition to any other activities required ….” Review on 6/13/2022 of the agency’s QAPI program failed to evidence documentation of any performance improvement projects. During an interview on 6/13/2022 at 10:29 AM, administrator A indicated the agency had not developed or documented a performance improvement project.

G0687

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 ensure policies and procedures were developed and implemented to ensure all staff were fully vaccinated for COVID-19. This practice had the potential to affect all agency patients. The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.70 Infection Control. The findings include: Record review on 6/9/2022 evidenced an agency policy updated 6/8/2022, titled “COVID-19 Policy” which failed to evidence any information regarding COVID-19 vaccination requirements for staff, a process for tracking and documenting vaccination status, and contingency plans for staff who were not vaccinated. Record review on 6/9/2022 of the agency’s COVID-19 Employee Vaccination Log, updated 6/8/2022, indicated 2 employees did not have COVID-19 vaccination documentation on file, and 3 employees “refused” COVID-19 vaccination without an exemption (19% of staff). 1 employee had an approved medical exemption on file. During an interview on 6/9/2022 at 11:20 AM, administrator A stated, when queried about why all staff was not vaccinated, “… I didn’t know they had to all be vaccinated because a few staff are young, and against the vaccine and refused … we don’t have exemptions on file for them … one staff member has a medical exemption ….” Administrator A indicated the agency received home health aide E’s vaccination documentation on 6/8/2022 and will keep in on file now. At 11:25 AM, administrator A called home health aide D, and requested the employee’s exemption to keep on file. At 11:45 AM, administrator A called home health aide F and asked if they had an exemption. Administrator A indicated the policies would be revised to reflect the 100% COVID-19 vaccination requirements. Administrator A indicated she would find out about HHA [home health aide] F, G and H’s COVID-19 vaccination status. On 6/10/2022 at 10:30 AM, administrator A provided further COVID-19 vaccination documentation, including an exemption for home health aide D and vaccination documentation for HHA E, G, and H. No exemption or vaccination documentation was provided for HHA F by end of survey.

G0716

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure skilled professionals accurately and completely prepared clinical notes in 4 of 7 clinical records reviewed. (#2, 3, 4, 7) The findings include: 1. Record review on 6/14/2022 evidenced an agency policy updated 6/10/2021, titled “Registered Nurse” which stated, “… be responsible for the ill, injured or infirm, and the maintenance of health and prevention of illness of others as well as … Prepares clinical and progress notes ….” 2. Observation of a home visit for patient #2 was conducted on 6/9/2022 at 2:00 PM to observe a routine skilled nurse visit. During the visit, the patient’s right and left shins were observed to have 5-10 small areas of pink skin each, which appeared to be scar tissue. Clinical record review for patient #2 was completed on 6/13/2022 for certification period 4/14/2022 – 6/12/2022. Record review evidenced a start of care/comprehensive assessment dated 4/14/2022, which stated, “… Patient states had multiple blisters that burst to both lower extremities … areas are scabbed over now ….” This document indicated the patient had wounds to bilateral shins. This document indicated pain did not interfere with movement or daily activities. Clinical record review evidenced a plan of care for certification period 4/14/2022 – 6/12/2022 which stated, “… Patient skin integrity will remain intact during this episode ….” Clinical record review evidenced a skilled nurse visit note dated 5/12/2022 which stated, “… Frequent of pain interfering with patient’s activity or movement: … All of the time … Patient has been suffering with joint pain since stroke which caused inability for him to move, walk ….” During an interview on 6/13/2022 at 12:00 PM, when queried about how patient #2 could meet goal of being free from skin breakdown if he already had wounds on start of care, registered nurse B stated, “… they aren’t wounds to me, so I would just take the wounds off for the next visit … I shouldn’t have put them on there as a wound ….” Registered nurse B indicated documenting the patient had wounds was an error. At 12:16 PM, when queried why the comprehensive assessment indicated pain does not interfere with daily activities, and the nurse visit note indicated pain interferes daily, registered nurse B stated, “… he has pain all the time, but it doesn’t interfere with his daily activities … maybe it was mistake ….” 3. Observation of a home visit for patient #3 was conducted on 6/10/2022 at 8:45 AM to observe a routine home health aide visit. The patient was observed to be alert and oriented, and able to ambulate with a walker as needed. Patient had the ability to feel pain and discomfort and voice such discomfort. Clinical record review for patient #3 was completed on 6/13/2022 for certification period 4/13/2022 – 6/11/2022. Record review evidenced a start of care/comprehensive assessment dated 4/13/2022, which included a Braden scale which stated, “… Very limited … Responds only to painful stimuli. Cannot communicate discomfort except by moaning or restlessness or has a sensory impairment which limits the ability to feel pain or discomfort over ½ of body ….” During an interview on 6/13/2022 at 12:55 PM, when queried why the comprehensive assessment indicated patient has inability to communicate or feel pain, registered nurse B stated, “… I think I meant to put 3 for that one … She is capable ….” 4. Clinical record review for patient #4 was completed on 6/13/2022 for certification periods 3/14/2022 - 5/12/2022 and 5/13/2022 – 7/11/2022. Record review evidenced skilled nurse visit notes for dates 5/6/2022, 5/16/2022, 5/20/2022, 5/26/2022, 6/3/2022, 6/7/2022, and 6/9/2022 which all stated, “… Dressing to left heel removed. Small amount of drainage noted. Wound decreasing in size. Wound was cleaned and sterile dressing applied ….” Review of these skilled nurse visit notes failed to evidence documentation of wound measurements, color of drainage, type of sterile dressing applied, or type of wound cleanser used. Skilled visit note dated 5/6/2022 indicated date of onset of left heel wound was 5/6/2022. Skilled visit note dated 5/16/2022 indicated the date of onset of left heel wound was 5/16/2022. Skilled visit note dated 5/20/2022 indicated the date of onset of left heel wound was 5/20/2022. Skilled visit note dated 5/26/2022 indicated the date of onset of left heel wound was 5/26/2022. Skilled visit note dated 6/3/2022 indicated the date of onset of left heel wound was 6/3/2022. Skilled visit note dated 6/7/2022 indicated the date of onset of left heel wound was 6/7/2022. Skilled visit note dated 6/9/2022 indicated the date of onset of left heel wound was 6/9/2022. Record review failed to accurately evidence the correct date of onset of left heel wound. Clinical record review evidenced skilled nurse visit notes for 6/3/2022, 6/7/2022, and 6/9/2022 which all stated, “… patient c/o [complains of] bronchitis like symptoms … physician notified ….” Record review failed to evidence which physician was notified, on what date and time. Clinical record review evidenced a skilled nurse visit note dated 6/7/2022, which indicated the patient’s suprapubic catheter (a tube inserted directly into the bladder to drain urine) was changed during the 6/7/2022 visit but failed to include any documentation of catheter change such as supplies used, how procedure was performed, or how patient tolerated procedure. During an interview on 6/13/2022 at 2:25 PM, when queried when wounds should be measured and documented on, administrator/clinical manager A indicated every visit wounds should be measured. Registered nurse B indicated wounds should be measured when dressing is changed but did not include measurements for patient #4’s wound because it was less than a centimeter. When queried what wound documentation should include, registered nurse B indicated the type of dressing, drainage amount, odor, and color. At 2:27 PM, registered nurse B stated, when queried what type of sterile dressing was applied to patient #4’s left heel wound, “… a sterile 2x2 gauze dressing. Why is it sterile, because that’s me, he didn’t order it ….” When queried how the onset date of left heel wound should be documented, administrator/clinical manager A indicated the onset date should be the date the wound was first assessed. Registered nurse B indicated they thought the onset date was supposed to be the date of visit for wound care. At 2:33 PM, when queried what should be documented when a catheter is changed, registered nurse B stated, “… that I changed it under sterile conditions and a new one was inserted … the size … dressing applied … how urine is draining … color … external area around site … that the patient tolerated it well ….” At 2:48 PM, when queried why 6/7/2022, 6/3/2022, and 6/9/2022 visit notes all say the same thing, registered nurse B stated, “… probably because I copy and pasted ….” 5. Clinical record review for patient #7 was completed on 6/13/2022 for certification period 1/22/2022 – 3/22/2022. Record review evidenced a patient communication note dated 1/20/2022 which stated, “… As he got to the doorway, lost his grip and we eased him to the floor ….” This document indicated it was electronically signed by registered nurse B on 1/20/2021, but the date of contact was 1/20/2022. Clinical record review evidenced a recertification/comprehensive re-assessment dated 1/20/2022 which included a fall risk assessment tool. The clinician failed to mark “Yes” under the option which stated, “… Prior history of falls within 3 months: Fall definition: ‘An unintentional change in position resulting in coming to rest on the ground or at a lower level’….” During an interview on 6/13/2022 at 4:12 PM, when queried why the fall assessment did not include the fall patient had on 1/20/2022, administrator/clinical manager A indicated it should have been included. When queried why the patient communication note was for a visit 1/20/2022, but electronically signed on 1/20/2021, administrator/clinical manager A indicated it was a mistake in charting. 410 IAC 17-14-1(a)(1)(E)

Survey of September 8, 2021

13 findings

G0000

This visit was a second post-condition re-visit survey of a home health agency. Dates: 09/03/2021, 09/07/2021, 09/08/2021 Facility #012829 Medicare ID: 157650 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. A complaint survey was conducted with an exit date of 03/04/2021 and found the home health agency to be out of compliance with Condition of Participation 42CFR 484.60 Care Planning, Coordination of Care, and Quality of Care. A post-condition revisit was conducted with an exit dated of 06/11/2021 and found the home health agency to be out of compliance with Condition of Participation 42CFR 484.45 Reporting OASIS Information and 484.60 Care Planning, Coordination of Care, and Quality of Care. During this second post-condition visit, Noble Home Health Care LLC was found to be in compliance with 42CFR 484.45 Reporting OASIS information and 42CFR 484.60 Care Planning, Coordination of Care and Quality of Care. Noble Home Health Care was found to have corrected 9 federal standard deficiencies, 7 standard deficiencies were recited and were cited for 5 new deficiencies. Based on the condition-level deficiencies cited during the 06/11/2021 survey and pursuant to Section 1891(a)(D)(iii) of the Act, Noble Home Health Care LLC continues to be precluded from providing home health aide training and/or a competency evaluation program for a period of 2 years beginning 06/11/2021 – 06/10/2023, due to being found out of compliance with the Condition of Participation at 42CFR 484.45 Reporting OASIS information and 42CFR 484.60 Care Planning, Coordination of Care and Quality of Care.

G0528

G0536

G0572

G0590

G0592

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure they revised the plan of care based on a change in the patient’s condition and needs, in 1 of 4 clinical records reviewed. (#2) The findings include: Record review of an agency policy, updated 6/10/21, titled “Admission Criteria” stated “… Procedure: … 4. … b. The plan of care must be developed in conjunction with agency staff and must cover all pertinent diagnoses, including mental status, types of services and equipment required, frequency of visits at the time of admission, prognoses, functional limitations, activities permitted, nutritional requirements, medications and treatments, any safety measures to protect against injury, and any other appropriate items. The appropriate health care personnel must perform services as specified in the plan of care. The plan of care must be revised as necessary, but it must be reviewed and updated at least every sixty days. Record review of an agency policy, updated 6/10/21, titled “Physician Orders/Plan of Care” stated “… Policy: The physician establishes and reviews a plan of treatment for the patient. The plan is updated and is maintained as part of the Agency’s clinical record. … 7. The physician and appropriate professional staff will review and recertify the written plan of care at least once per episode and as warranted by the patient’s condition. … 10. The Agency provides written and oral reports to the physician regarding the patient’s plan of treatment and appropriateness of the continuation of care. The Agency provides written and oral reports to the physician regarding the patient’s condition at least every 60 days. Reports may be more frequent if there is an emergency, a need to alter the plan of care or a need to terminate services….” Record review of an agency policy, updated 6/10/21, titled “Care Planning” stated “… 5. The patient’s Plan of Care will be revised promptly upon reassessment of status changes in the patient. … 11. The Plan of Care is revised as frequently as deemed necessary by the Clinical Manager/Case Manager/Therapist and the qualified professional based on on-going assessments of the patient….” Clinical record review for patient #2, start of care 04/26/2018, certification period 08/18/2021 – 10/06/2021, primary diagnosis of idiopathic epilepsy with seizures, evidenced an agency document titled “Home Health Certification and Plan of Care” dated and signed by the primary care physician on 08/24/21. This plan of care had an area subtitled “Orders and Treatments” which stated “… HHA [home health aide] 7 hours a day, 7 days a week….” Clinical record review evidenced agency documents titled “HHA Visit” dated 8/8/21, 8/9/21, 8/10/21, 8/11/21, 8/12/21, 8/13/21, 8/14/21, 8/15/21, 8/16/21, 8/17/21, 8/18/21, 8/19/21, 8/20/21, 8/21/21, 8/23/21, 8/24/21, 8/25/21, 8/26/21, 8/27/21, 8/28/21, 8/29/21, 8/30/21, 8/31/21 and 9/1/21. Each of these home health aide visit notes indicated the home health aide provided services from 8:00 a.m. – 2:30 p.m., this was a total of 6.5 hours each visit. The home health agency failed to ensure the home health aide provided services 7 hours a day as directed by the primary care physician in the plan of care. During an interview on 09/03/2021 at 2:02 p.m., the administrator indicated the patient only wanted 6.5 hours of home health aide services, because he wanted to take a nap. During an interview on 09/03/2021 at 2:05 p.m., the administrator indicated they needed to update the plan of care. 17-14-1(a)(1)(c)

G0612

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on observation and interview, the home health agency failed to ensure all patients had written instructions outlining their care in their home folder, in 1 of 1 home visit conducted. (#4) The findings include: During a home visit with patient #4 and home health aide (HHA) I, on 09/07/2021 at 2:30 p.m., HHA I was observed searching the patient’s entire bedroom for the home health agency’s home folder. The home health aide did find some Noble Home Health documents in a clear sleeve. Review of these documents evidenced a complaint hotline document, patient rights document and an advanced directive document. There was no evidence of a plan of care. During an interview on 09/07/2021 at 3:20 p.m., the administrator indicated she knew everyone was given all those things for their folder.

G0614

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation and interview, the home health agency failed to ensure a visit schedule was in agency patients home folders, in 1 of 1 home visit conducted. (#4) The findings include: During a home visit with patient #4 and home health aide (HHA) I, on 09/07/2021 at 2:30 p.m., HHA I was observed searching the patient’s entire bedroom for the home health agency’s home folder. The home health aide did find some Noble Home Health documents in a clear sleeve. Review of these documents evidenced a complaint hotline document, patient rights document and an advanced directive document. There was no evidence of a visit schedule. During an interview on 09/07/2021 at 2:25 p.m., patient #4 indicated she always knew when the home health aide was coming, because “he is always on time.” During an interview on 09/07/2021 at 3:20 p.m., the administrator indicated she knew everyone was given all those things for their folder.

G0616

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure patient medication schedule/instructions were in the agency patients home folder, in 1 of 1 home visit conducted. (#4) The findings include: Record review of an agency policy, updated 6/10/21, titled “Client Records” stated “… Procedure: … i. Instructions to the patient and caregiver or guardian, including administration of and adverse reactions to medications….” During a home visit with patient #4 and home health aide (HHA) I, on 09/07/2021 at 2:30 p.m., HHA I was observed searching the patient’s entire bedroom for the home health agency’s home folder. The home health aide did find some Noble Home Health documents in a clear sleeve. Review of these documents evidenced a complaint hotline document, patient rights document and an advanced directive document. There was no evidence of a medication schedule/instructions. During an interview on 09/07/2021 at 3:20 p.m., the administrator indicated she knew everyone was given all those things for their folder.

G0682

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 home health aides followed universal precautions to prevent infectious and communicable diseases in 1 of 1 home visit with a home health aide. (#4) The findings include: Record review of an agency policy, updated 6/10/21, titled “Universal Body Substance Precautions” stated “… Purpose: To reduce the risk of exposure to and transmission of infections when caring for patients. Policy: 1. Under Universal Body Substance Precautions, blood and certain body fluids of all patients are considered potentially infectious for bloodborne pathogens such as human immunodeficiency virus (HIV), and hepatitis B virus (HBV). Universal Body Substance Precautions apply to blood and other body fluids potentially containing blood or bloodborne pathogens. 2. These body fluids include emesis, sputum, feces, urine … 4. Agency personnel will adhere to the following precautions and will instruct patients/patient representatives and/or families/caregivers in infection control precautions as appropriate to the patient’s needs. … Procedure: 1. General Precautions a. Handwashing is the single most important activity a staff member can undertake to help prevent the spread of infection. It will be performed at the following times: Before and after patient contact Before and after using gloves … After contact with soiled or contaminated items (i.e., bedpans, urinal, catheter, linens) … b. Use antimicrobial soap, warm water, and friction for hand washing. Lather and scrub for ten (10) seconds. Rinse well, beginning at fingertips so dirty water runs off at wrists. Dry hands on paper towels. Use dry paper towels to turn off faucets. … e. Gloves: The use of gloves (intact latex or latex-free if person is allergic) of appropriate size and quality) is important where the worker has cuts, abraded skin, chapped hands, dermatitis, etc., … Gloves are to be worn when handling soiled linen….” Record review of an agency policy, updated 6/10/21, titled “Hand washing” stated “… Purpose: To cleanse the hands of germs and prevent contamination between patients and home care personnel. Hand washing before and after contact with each patient is the single most important means of preventing the spread of infection. When hands are not visibly soiled, waterless hand antiseptics are encouraged for routine hygiene between patient contacts Policy: 1. All personnel will wash their hands: a. Upon arrival to work b. Before and after EACH contact with a patient. c. After handling bed pans, urinals, catheters, linens … 2. Towels, either cloth or paper, and liquid soap will be used, if available. If not available, bar soap can be used but should be thoroughly rinsed between uses. Waterless hand washing products may also be used. … Hand washing Goal is for 100 percent compliance with this policy….” Record review of an agency policy, updated 6/10/21, titled “Bag Technique” stated “… Purpose: To establish guidelines for the visiting home health care personnel regarding the appropriate use of the bag and transporting reusable equipment from house to house. Objective: To prevent contamination of reusable equipment carried by home health personnel from patient to patient. Responsible Personnel: All visiting staff. … Principles of Bag Technique: … 2. Hand washing supplies should be kept readily available either in a side-pocket of the bag, or in a zip lock baggie directly on top of the bag contents upon opening the bag. … Action: If the home environment does not pose a great risk of contamination to the bag, the staff will carry the bag into the home. After entering the home, the bag is placed on a clean area that isn’t visibly soiled. Avoid using the floor. Disposable barriers may be used if the home environment poses a threat to the cleanliness of the bag. Rationale: To reduce the risk of contamination….” Observation was made of a home visit with patient #4 and HHA [home health aide] I on 09/07/2021 at 2:00 p.m. Upon entrance into the home the home health aide was observed placing his nursing bag upon the patient’s couch with no barrier in between the couch and the nursing bag. HHA I then was observed going directly into the patient’s bedroom, donned a pair of gloves, walked to the patient’s bedside, and began emptying the patient’s foley catheter bag into a pink wash basin. HHA I failed to wash his hands upon entry to the home and prior to donning gloves. HHA I then took the basin full of urine and emptied it into the patient’s toilet, rinsed the basin out with water, then empties the water in the basin into the patient’s toilet and flushed the toilet. HHA I then placed the basin back at the side of the patient’s bed. At 2:05 p.m., HHA I was observed removing his gloves and then placed on a clean pair of gloves, failing to be observed washing/sanitizing his hands prior to the donning of the new gloves. HHA then pulls the patient’s linen down on the bed and checks the patient’s colostomy bag and indicated it was empty. Observation was made of a very small amount of fecal matter next to the stoma. HHA I then turns the patient to her right side and observed a wound bandage on the patient’s right upper leg. HHA I then straightens up the patient’s chux pad and bed linen. HHA I failed to wash or sanitize his hands and change his gloves after he was observed touching the patient’s colostomy bag and buttocks. HHA I then removed the old chux and disposed of it in the trash, lowered the patient’s bed, turned the patient to her right side, touched her buttocks and observed the patient’s skin. HHA then removed the patient’s pillow from the bed, moved the patient’s IV pole, and moved the patient’s blankets. At 2:14 p.m., HHA I was observed pulling the patient up in her bed and then straightened up her bed linen. Then HHA begins to rifle through all the patient’s paperwork, binders and folders looking for the home health agency’s folder. HHA I was never observed to have washed his hands, perform hand antisepsis, or change his gloves after he emptied the basin of urine. HHA I failed to follow universal precautions. During an interview on 09/07/21 at 2:14 p.m., patient #4 indicated she was on IV antibiotics for a urinary tract infection and finished her course of antibiotics on 09/02/2021. 17-12-1(m)

G0800

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the home health aides followed the aide care plan established by the registered nurse, in 3 of 4 clinical records reviewed with home health aide services. (#1, #3, #4) The findings include: 1. Review of an agency policy, updated 6/20/21, titled “Home Health Aide” stated “… Purpose: To ensure that all home health aide visits responsibilities are clearly stated. … Procedure: The home health aide shall have the following responsibilities: 1. Provide services that are ordered by the physician in the plan of care, only those services written in the plan of care and received as written instructions from the registered nurse supervisor as permitted under State law….” 2. Clinical record review for patient #1, start of care 08/13/2021, certification period 08/13/2021 – 10/11/2021, primary diagnosis of essential hypertension, evidenced an agency document titled “Home Health Certification and Plan of Care” dated and signed by the primary care physician on 08/16/2021. This plan of care had an area subtitled “Orders and Treatments” which stated “… HHA [home health aide]: 10-12 hours per day, 5 days a week to assist with all IADL [instrumental activities of daily living], ADL [activities of daily living], . Home Health Aide to provide assistance with personal care and ADL as indicated by limitations on functional and physical status impeding self care. Assist with personal care, ADLs IADL light housekeeping supervision, fall prevention and meal prep, etc….” Clinical record review evidenced an agency document titled “Aide Care Plan” for certification period 08/13/2021 – 10/11/2021, created by the administrator. This document indicated the home health aide was to take the patient’s temperature, provide incontinent care, record bowel movement, provide light housekeeping, make bed, assist to dress, check pressure areas, provide foot care, provide oral hygiene denture care, provide skin care, and practice universal precautions per visit. This aide care plan indicated the home health aide was to provide linen change and provide a shower on Monday, Wednesday and Friday, and shampoo hair per patient’s preference. Clinical record review evidenced an agency document titled “HHA [home health aide] Visit” dated 08/24/2021 and indicated HHA D provided care. This document failed to evidence HHA D took the patient’s temperature as instructed by the registered nurse. The administrator remained silent when this information was reviewed with her on 09/03/2021 at 3:15 p.m. 3. Clinical record review for patient #3, start of care 01/28/2021, certification period 07/27/2021 – 09/24/2021, primary diagnosis of Parkinson’s disease, evidenced an agency document titled “Home Health Certification and Plan of Care” dated and signed by the primary care physician on 08/24/2021. This plan of care had an area subtitled “Orders and Treatments” which stated “… HHA: 8 hours per day5 [sic] days a week to assist with all IADL, ADL, … Patient is dependent on others for all ADL and IADL Home health aide duties may include but are not limited to: Personal hygiene care, transfers/turning, positioning, medication reminders, meal preparations, wound prevention, incontinent care, checking integumentary status and light housekeeping….” Clinical record review evidenced an agency document titled “Aide Care Plan” dated on signed by the administrator on 07/27/2021. This aide care plan indicated the home health aide was to provide temperature, incontinent care, record bowel movement, assist in ambulation, assist in transfer, range of motion, turn or position, light housekeeping, make bed, assist to dress, check pressure areas, oral hygiene denture care, pericare, skin care, shower, and universal precautions per visit. The home health aide was to provide a linen change on Wednesdays and as needed when soiled. The home health aide was to provide foot care, nail care, shampoo hair and a shave per the patient’s preference. Clinical record review evidenced agency documents titled “HHA [home health aide] Visit” dated 7/28/21, 7/29/21, 8/2/21, 8/3/21, 8/4/21, 8/5/21, 8/9/21, 8/10/21, 8/11/21, 8/12/21, 8/13/21, 8/16/21, 8/17/21, 8/18/21, 8/19/21, 8/20/21, 8/23/21, 8/24/21, 8/25/21, 8/26/21, 8/27/21, 8/30/21, 9/1/21, 9/2/21 and 9/3/21. These home health aide visits failed to evidence the patient was provided a shave or refused a shave. The home health aide failed to follow the aide care plan. Clinical record review evidenced an agency document titled “HHA Visit” dated 08/02/21 and digitally signed by HHA D. This home health aide visit note failed to evidence the home health aide took the patient’s temperature as indicated on the aide care plan. Clinical record review evidenced agency documents titled “HHA Visit” dated 08/02/21 (p.m. visit), 08/03/21, 08/06/21, 08/09/21, 08/20/21, 08/12/21, 08/13/21, 08/16/21, 08/17/21, 08/19/21, 08/20/21, 08/23/21, 08/24/21, 08/27/21 (p.m. visit), 08/30/21 (p.m. visit), 08/31/21, 09/01/21 (p.m. visit), 09/02/21 and 09/03/21. These home health aide notes failed to evidence if the home health aide provided a linen change as indicated on the aide care plan. Clinical record review evidenced an agency document titled “HHA Visit” dated 08/02/21 (p.m. visit) and digitally signed by HHA D. This home health aide visit note failed to evidence if the home health aide provided incontinent care as indicated on the aide care plan. Clinical record review evidenced agency documents titled “HHA Visit” dated 08/05/21, 08/25/21 (p.m. visit), 08/26/21, 08/31/21 (p.m. visit), 09/01/21 (p.m. visit), 09/02/21 and 09/03/21 (p.m. visit). These home health aide notes failed to evidence if nail care was provided as indicated on the aide care plan. Clinical record review evidenced agency documents titled “HHA Visit” dated 08/25/21, 08/30/21 (p.m. visit), 09/02/21 (p.m. visit) and 09/03/21 (p.m. visit). These home health aide notes failed to evidence if foot care was provided as indicated on the aide care plan. Clinical record review evidenced agency documents titled “HHA Visit” dated 08/25/21 and 09/02/21. These home health aide notes failed to evidence if a shampoo was provided as indicated on the aide care plan. Clinical record review evidenced agency documents titled “HHA Visit” dated 08/25/21 and 09/03/21 (p.m. visit). These home health aide notes failed to evidence if the patient was verbally reminded to turn and position as indicated on the aide care plan. Clinical record review evidenced agency documents titled “HHA Visit” dated 08/25/21, 08/30/21 (p.m. visit) and 09/03/21 (p.m. visit). These home health aide notes failed to evidence the patient’s last bowel movement was recorded as indicated on the plan of care. Clinical record review evidenced an agency document titled “HHA Visit” dated 09/30/21 (a.m. visit) and digitally signed by HHA E. This home health aide note failed to evidence the patient was provided assistance to dress as indicated on the aide care plan. Clinical record review evidenced an agency document titled “HHA Visit” dated 08/30/21 (p.m. visit) and digitally signed by HHA F. This home health aide note failed to evidence range of motion was provided as indicated on the aide care plan. Clinical record review evidenced an agency document titled “HHA Visit” dated 09/01/21 (a.m. visit) and digitally signed by HHA E. This home health aide note failed to evidence a shower was provided as indicated on the aide care plan. During an interview on 09/08/21 at 1:00 p.m., the administrator indicated she had counseled the home health aides about this. 4. Clinical record review for patient #4, start of care 06/10/2019, certification period 07/29/2021 – 09/26/2021, primary diagnosis of essential hypertension, evidenced an agency document titled “Home Health Certification and Plan of Care” dated and signed by the administrator on 07/29/2021. This plan of care had an area subtitled “Orders and Treatments” which stated “… HHA: HHA 8-10 hours a day 7 days a week, … Home health aide requested to provide 8 – 10 hours per day, 7 days per week, for 26 weeks. … Home health aide duties may include but are not limited to: personal hygiene care, bathing/showering, assisting with transfers, turning/positioning, assistance with wound prevention, Foley care, ostomy care, checking integumentary status, medication assistance and reminders, meal preparations, and light housekeeping….” Clinical record review evidenced an agency document titled “Aide Care Plan dated 07/29/2021 and digitally signed by the administrator. This aide care plan indicated the home health aide was to provide temperature check, catheter care, empty ostomy bag, record bowel movement, assist in transfer, range of motion, turn or position, light housekeeping, assist to dress, check pressure areas, foot care, oral hygiene denture care, skin care and practice universal precautions each visit. This aide care plan indicated the home health aide was to provide a back rub/massage, comb hair, complete bath, partial bath/sponge, and shampoo hair per patient’s preference, provide pericare when patient was soiled, and was to change linen on Wednesday and when soiled. Clinical record review evidenced agency documents titled “HHA Visit” dated 08/24/2021, 08/25/2021, 08/26/2021, 08/27/2021, 08/29/2021, 08/31/2021, 09/01/2021, 09/02/2021, 09/03/2021 and 09/04/2021. These home health aide visit notes failed to evidence the home health aide provided record bowel movement, complete bath, and back rub/massage. The home health aide failed to follow the aide care plan. Clinical record review evidenced agency documents titled “HHA Visit” dated 08/24/2021, 08/25/2021, 08/26/2021, 08/27/2021, 08/28/2021, 08/29/2021, 08/31/2021, 09/01/2021, 09/02/2021, 09/03/2021 and 09/04/2021. These home health aide visit notes failed to evidence the home health aide provided the patient with shampoo hair. The home health aide failed to follow the aide care plan. Clinical record review evidenced an agency document titled “HHA Visit” dated 08/28/2021 and digitally signed by HHA J. This home health aide visit note failed to evidence the home health aide changed linen. The home health aide failed to follow the aide care plan. Clinical record review evidenced an agency document titled “HHA Visit” dated 09/05/2021 and digitally signed by HHA I. This home health aide visit note failed to evidence the home health aide provided assistance to dress, complete bath, comb hair, foot care, pericare, shampoo hair, skin care, universal precautions, back rub/massage, oral hygiene denture care, check pressure areas, partial bath and record last bowel movement. The home health aide failed to follow the aide care plan.

G0818

G1024

Survey of March 4, 2021

17 findings

G0000

This visit was for a complaint survey which was fully extended. Survey Dates: 2/25/2021 to 3/4/2021 Complaints: IN00315216 - substantiated with related findings IN00332220 - substantiated with related findings IN00320943 - substantiated with related findings Facility ID: 012829 These deficiencies reflect State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. Noble Home Health Care is precluded from providing its own home health training and competency evaluation for a period of two years beginning 3/4/2021 - 3/3/2023 due to being found out of compliance with the Conditions of Participation 42 CFR 484.60 Care Planning, Coordination of Services, and Quality of Care. Quality Review completed on 4/7/2021 A4

G0444

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients were advised of the state toll free home health telephone hotline contact information for 3 of 3 home visits out of a total sample of 10 patient records reviewed (#2, #3, #7). Findings include: 1. Record review on 3/2/2021 evidenced an agency policy titled, "Client Conduct, Responsibility and Rights", number 3.001.1, which stated, " ... the agency must inform the patient and / or patient representative orally and in writing of the following: ... 49. Be informed of your state's home health agency hotline and the agencies contact information [sic] make suggestions or complaints, or present grievances on behalf of the patient to the agency, government agencies, or other persons without threat or fear of retaliation...." 2. Review of sample admission folder received on 2/25/2020 from employee A, RN [registered nurse], failed to evidence the state toll free home health hotline information. 3. Review of admission folder at a home visit for patient #2 on 2/26/2021 at 9:55 a.m. failed to evidence written information about the state toll free home health hotline. During an interview on 2/26/2021 at 10:00 a.m., person C, caregiver to patient #2, indicated she did not have any written information from the agency about the state home health hotline. 4. Review of admission folder at a home visit for patient #3 on 3/1/2021 at 12:00 p.m. failed to evidence written information about the state toll free home health hotline. 5. During an interview on 3/3/2021 at 3:55 p.m., the administrator indicated the agency failed to ensure patients had information about the state home health hotline. 6. Review of admission folder at a home visit for patient #7 on 2/26/2021 at 10:39 AM, failed to evidence written information about the state toll free home health hotline. 17-12-3(b)(2)(C)

G0548

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a comprehensive assessment was performed within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more in 1 of 1 records of patients with hospitalization reviewed (#2). The findings include: 1. Record review on 3/2/2021 evidenced an agency policy titled, "Comprehensive Assessment of Patients (OASIS)", number 6.019.1, which stated, " ... Policy: A comprehensive assessment incorporating the Outcomes and Assessment Information Set (OASIS) utilizing the most current approved version will be performed on qualified patients at: Start of care; Within 48 hours following a hospital discharge for any reason except diagnostic testing...." 2. Clinical record review on 3/2/2021 for patient #2, start of care 8/13/2020, certification period 12/11/2020 to 2/8/2021, primary diagnosis of Multiple Sclerosis, evidenced an agency document titled, "Post Hospital Order". This order indicated the patient was admitted to the hospital from 12/18/2020 to 12/27/2020. Review of the electronic medical record evidenced HHA [home health aide] visits resumed on 12/28/2020. Review of the electronic medical record failed to evidence a comprehensive assessment was performed following the hospitalization. 3. During an interview on 3/4/2021 at 11:00 a.m., the clinical manager indicated a comprehensive assessment should be done at start of care, resumption of care, and every 60 days. When queried, the clinical manager stated about the comprehensive assessment, "There is not an uploaded one. I am behind."

G0570

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 they were able to meet the patient needs (see tag G0570); failed to ensure each patient received home health services written in their plan of care, the plan of care was individualized, and the plan of care was signed by the patient's physician (see tag G0572); the plan of care contained all medications, medical equipment and patient-specific interventions and goals for their patients (see tag G0574); the home health agency staff promptly alerted the primary care physician to changes in the patients condition (see tag G0590); the plan of care was revised to reflect the current health status and nursing needs of the patient (see tag G0592); discharge plans were communicated to the patient and patient's physician (G0598); there was coordination of care amongst the different disciplines / entities that provided care to agency patients (see tag G0606); patients were provided a written schedule of visits (see tag 614); and patients were provided a current written patient medication list (see tag 616). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42 CFR 484.60 Care Planning, Coordination of Services, and Quality of Care. In regards to G0570, findings include: 1. An undated agency policy number 4.004.1, with a subject subtitled "Physician Orders/Plan of Care" stated, "Purpose: To ensure that each patient's care is under the direction of a physician ... Policy: The physician establishes and reviews a plan of treatment for the patient. The plan is updated and maintained as part of the agency's clinical record ... Procedure: 1. The physician sets up a Plan of Care, which includes the diagnosis, prognosis, goals to be accomplished, in order for each service, an item of drugs and equipment to be provided by the agency. 2. All orders on the CMS 485 will be specific to the client condition in needs ... 5. Copies of the plan of care in other orders requiring a physician's signature should be filed in the client record within 60 days of receipt in office ... 7. The physician and appropriate professional staff will review an recertify the written plan of care at least once per episode and as warranted by the patient's condition... 9. The agency's professional staff will review the clinical records on a continuous basis to ensure each POC is specific to the patient and that additional orders for services are present in the clinical record .... " 2. An undated agency policy number 6.016.1, with a subject subtitled "Care Planning" stated, "Purpose: To define a systematic process to the clinicians for planning, reviewing and revisiting patient care or services either directly or through a written agreement ... Policy: 1. It is the policy of this Agency to provide individualized, planned, appropriate care, treatment and or services based on the patient's needs and goals with the input of the patient for the purpose of achieving positive outcomes." 3. An undated agency policy titled, "Rights, Responsibilities and Ethics", number 3.001.1, which stated, " ... 35. Receive the care necessary to assist you in attaining optimal levels of health...." 4. Clinical record review on for patient #2, start of care 8/13/2020, certification period of 12/11/2020 to 2/8/2021, primary diagnosis of Multiple Sclerosis, evidenced a document identified by the clinical manager as the prior authorization request for patient #2 for 1/26/2021 to 7/25/2021. This document stated, " ... HHA [home health aide] to provide assistance with all ADLS [activities of daily living] and safety measures 6 hr Mon to Sat [6 hours Monday to Saturday]...." During an interview on 3/4/2021 at 3:48, the clinical manager indicated the prior authorization request should be accurate to what the patient needed. Clinical record review evidenced an agency document titled, "Home Health Certification and Plan of Care", signed by the physician on 2/27/2021, which stated, " ... Home health aide requesting to provide 6 hours a day, up to 6 days a week, for 26 weeks...." Review of the patient's electronic clinical record, evidenced the agency provided the following HHA hours: for the week of 12/27/2020 to 1/2/2021, the patient received 6 hours per day for 3 days, the week of 1/3/2021 to 1/9/2021, the patient received 6 hours per day for 4 days, for the week of 1/10/2021 to 1/16/2021, the patient received 6 hours per day for 5 days, the week of 1/24/2021 to 1/30/2021, the patient received 6 hours per day for 5 days, and for the week 1/31/2021 to 2/6/2021, the patient received 6 hours per day for 5 days. During an interview on 2/26/2021 at 9:59 a.m., person C, caregiver to patient #2, indicated HHA hours were missed because staff did not show up. Person C indicated that HHA C is the only HHA who works as scheduled. When informed of the findings on 3/4/2021 at 11:12 p.m., the clinical manager stated, "It's not for lack of trying. We have offered. They refuse aides." The clinical manager indicated the agency failed to evidence documentation of communication with the family regarding staffing. 5. Clinical record review for patient #5, start of care 8/31/2020, certification period 12/29/2020 to 1/29/2021, primary diagnosis of legal blindness, evidenced an agency document titled, "Home Health Certification and Plan of Care", which stated, " ... Home Health Aide requesting to provide 6 (up to 12) hours a day, 5 days a week; based on patient need / request. Patient requires 12 hours of assistance a day; at this time she is utilizing her home making service for 6 of those 12 hours. On occasion, they are not available and when that happens, patient will request to use up to 12 hours on those days...." Review of the patient's electronic clinical record, evidenced the agency provided the following HHA hours: for the week of 12/29/2020 to 1/2/2021, the patient received 3.5 hours one day, and 6 hours a day for 2 days; for the week of 1/3/2021 to 1/9/2021, the patient received 6 hours per day for 3 days; for the week of 1/10/2021 to 1/17/2021, the patient received 2.5 hours one day, 3.5 hours one day, 5 hours per day for 2 days, 6 hours for one day; for the week of 1/17/2021 to 1/23/2021, the patient received 2 hours one day, 3.5 hours one day, and 6 hours per day for 3 days; for the week of 1/24/2021 to 1/30/2021, the patient received 3.5 hours one day, and 6 hours per day for 3 days. During an interview on 3/4/2021 at 1:43 p.m., the clinical manager indicated the agency was having difficulty staffing HHA visits due to not enough staff. She stated, "We are all struggling. We are trying to hire." 6. Clinical record review on 3/4/2021, for patient #6, start of care 6/21/2019, failed to evidence a plan of care had been established and signed by the patient's physician, for certification period 2/16/2020 - 4/15/2020. Record review evidenced the patient received 48 hours per week during this certification period. Record review evidenced care being provided to the patient without a signed plan of care. Record review evidenced a document titled "Indiana Medicaid Prior Authorization Update Notification" dated 1/28/2020. This document had an area subtitled "Service Requested" which stated "Service Description: Home Visit NOS [not otherwise specified] ... Units Requested: 1416.00 [equivalent to 54.5 hours per week] ... Units Authorized: 1,280.00 [49.2 hours per week] .... " Record review failed to evidence the patient received the amount of service hours needed, as requested by the agency. During an interview on 3/4/2021, at 11:23 AM, the clinical manager indicated the patient was very hard to get a hold of and did not know if a plan of care was sent to the physician for an authorized signature. 7. Clinical record review on 3/4/2021, for patient #7, start of care 4/5/2017, primary diagnosis of cerebral palsy, evidenced a document titled "Home Health Certification and Plan of Care" for certification period 1/14/2021 - 3/14/2021. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide up to 2 hrs [hours] per day, 7 days a week for 26 weeks [up to 14 hours per week] ... Frequency and/or duration may be decreased if/when an available caregiver is present, willing, and able to assist .... " Record review evidenced this patient received care for 2 hours per day, 3 days a week (6 hours per week), since 12/14/2020. Record review evidenced a document titled "Indiana Medicaid Prior Authorization Update Notification" dated 10/19/2020. This document had an area subtitled "Service Requested" which stated "Service Description: Home Visit NOS ... Units Requested: 364.00 [equivalent to 14 hours per week] ... Units Authorized: 338.00 [equivalent to 13 hours per week] .... " Record review failed to evidence the patient received the amount of service hours needed, as requested by the agency. During an interview on 3/4/2021, at 11:32 AM, the clinical manager indicated the patient's hours were not being met due to the caregiver's request for specific home health aides only. 8. Clinical record review on 3/4/2021, for patient #9, start of care 10/30/2019, primary diagnosis of encephalopathy (disease which alters brain function), evidenced a document titled "Home Health Certification and Plan of Care" for certification period 6/26/2020 - 8/24/2020. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide up to 10 hours a day, up to 7 days a week [70 hours per week] for 26 weeks .... " Record review evidenced an average of 46 hours per week of home health aide services provided for this certification period. Record review evidenced a document titled "Indiana Medicaid Prior Authorization Update Notification" dated 4/30/2020. This document had an area subtitled "Service Requested" which stated "Service Description: Home Visit NOS ... Units Requested: 1820.00 [equivalent to 70 hours per week] ... Units Authorized: 1820.00 .... " Record review failed to evidence the patient received the amount of service hours needed, as requested by the agency. During an interview on 3/4/2021, at 12:41 PM, the clinical manager indicated hours were not being met due to the tremendous difficulty the agency had staffing the patient's home for 10 hours a day. 9. During an interview on 3/4/2021, at 3:48 PM, the clinical manager indicated the PA [prior authorization for Medicaid] should be accurate to the patient's needs. 10. During an interview on 3/4/2021, at 3:53 PM, the clinical manager indicated they did not know the agency can use a skilled nurse to meet the needs of home health aide visits. 17-13-1(a)

G0572

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure each patient received home health services written in their plan of care in 2 of 10 records reviewed (#7, #4), failed to ensure the plan of care was individualized in 2 of 10 records reviewed (#9, #10), and failed to ensure plan of care was signed by the patient's physician in 2 of 10 clinical records reviewed. (#6, #3) The findings include: 1. An undated agency policy number 4.004.1, with a subject subtitled "Physician Orders/Plan of Care" stated, "Purpose: To ensure that each patient's care is under the direction of a physician ... Policy: The physician establishes and reviews a plan of treatment for the patient. The plan is updated and maintained as part of the agency's clinical record ... Procedure: 1. The physician sets up a Plan of Care, which includes the diagnosis, prognosis, goals to be accomplished, in order for each service, an item of drugs and equipment to be provided by the agency. 2. All orders on the CMS 485 will be specific to the client condition in needs ... 5. Copies of the plan of care in other orders requiring a physician's signature should be filed in the client record within 60 days of receipt in office ... 7. The physician and appropriate professional staff will review an recertify the written plan of care at least once per episode and as warranted by the patient's condition... 9. The agency's professional staff will review the clinical records on a continuous basis to ensure each POC is specific to the patient and that additional orders for services are present in the clinical record .... " 2. An undated agency policy number 6.016.1, with a subject subtitled "Care Planning" stated, "Policy: 1. It is the policy of this Agency to provide individualized, planned, appropriate care, treatment and or services based on the patient's needs and goals with the input of the patient for the purpose of achieving positive outcomes..." 3. Clinical record review on 3/4/2021, for patient #6, start of care 6/21/2019, failed to evidence a plan of care had been established and signed by the patient's physician for certification period 2/16/2020 - 4/15/2020. During an interview on 3/4/2021, at 11:23 AM, the clinical manager indicated the lack of the patient's plan of care was an oversight. They further explained it was unknown if a plan of care had been sent to the physician for a signature. 4. Clinical record review on 3/4/2021, for patient #7, start of care 4/5/2017, primary diagnosis of cerebral palsy, evidenced a document titled "Home Health Certification and Plan of Care" for certification period 1/14/2021 - 3/14/2021. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide up to 2 hrs [hours] per day, 7 days a week for 26 weeks ... Frequency and/or duration may be decreased if/when an available caregiver is present, willing, and able to assist .... " Record review evidenced this patient received care for 2 hours per day, 3 days a week since 12/14/2020. Record review failed to evidence patient received home health services written in their plan of care. During an interview on 3/4/2021, at 11:32 AM, the clinical manager indicated the reason this patient did not receive the hours as ordered on the plan of care, is due to Person D, caregiver for patient #7. It is their preference to only utilize HHA D to furnish care on behalf of the agency. 5. Clinical record review on 3/4/2021, for patient #9, start of care 10/30/2019, primary diagnosis of encephalopathy (disease which alters brain function), evidenced a document titled "Home Health Certification and Plan of Care" for certification period 6/26/2020 - 8/24/2020. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide up to 10 hours a day, up to 7 days a week for 26 weeks .... " Record review failed to evidence the plan of care was individualized to meet the patient's needs. 6. Clinical record review on 3/4/2021, for patient #10, start of care 2/26/2019, primary diagnosis of progressive mutifocal leukoenchalopathy (disease of the white matter of the brain), evidenced a document titled "Home Health Certification and Plan of Care" for certification period 12/17/2020 - 2/14/2021. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide 4 hours a day, 7 days a week ... Frequency and/or duration may be decreased if/when an available caregiver is present, willing, and able to assist .... " Record review evidenced this patient received care for 6 hours a day, 7 days a week since 12/17/2020. Record review failed to evidence the plan of care was individualized to meet the patient's needs. During an interview on 3/4/2021, at 1:07 PM, the clinical manager indicated the duration stated on the plan of care was an oversight, and should written as 6 hours per day. 7. Clinical record review on 3/2/2021 for patient #3, start of care 2/17/2020, certification period 1/12/2021 to 3/2/2021, primary diagnosis of chronic obstructive pulmonary disease [a disease that causes long-term breathing problems], evidenced an agency document titled, "Home Health Certification and Plan of Care". This plan of care was not signed by the physician. On 3/4/2021 at 12:02 p.m., the clinical manager was informed of the findings and offered no additional documentation. 8. Clinical record review on 3/4/2021 for patient #4, start of care 9/10/2018, certification period 12/28/2021 to 2/25/2021, with diagnoses of legal blindness and cerebral palsy, evidenced an agency document titled, "Home Health Certification and Plan of Care". This plan of care had a subcategory titled, "Orders and Treatments", which stated, " SN [skilled nurse] to change inner cannula [the inner tube that fits within a tracheostomy tube] daily in the a.m. ... SN [skilled nurse] to place rolled towel in hands as tolerated and off at HS [bedtime] ... SN to apply bilateral [left and right] hand splints daily as tolerated and off at HS...." During an interview on 3/4/2021 at 12:20 p.m., the clinical manager indicated applying hand splints and placing rolled towels in hands should be documented in the narrative section of the nursing visit notes. Clinical record review evidenced a group of agency documents titled, "Nursing Flow Sheet Shift Assessment", identified as the skilled nursing visit notes by the clinical manager. The notes with the following dates failed to evidence applying hand splints and placing rolled towels in hands: 12/28/2021, 12/29/2021, 12/30/2021, 1/1/2021, 1/2/2021, 1/3/2021, 1/4/2021, 1/5/2021, 1/6/2021, 1/7/2021, 1/9/2021, 1/10/2021, 1/13/2021, 1/14/2021, 1/15/2021, 1/16/2021, 1/17/2021, 1/18/2021, 1/19/2021, 1/20/2021, 1/21/2021, 1/22/2021, 1/23/2021, 1/24/2021, 1/25/2021, 1/26/2021, 1/27/2021, 1/28/2021, 1/29/2021, 1/30/2021, 1/31/2021, 2/1/2021, 2/4/2021, 2/5/2021, 2/6/2021, 2/7/2021, 2/8/2021, 2/9/2021, 2/10/2021, 2/11/2021, 2/12/2021, 2/13/2021, 2/14/2021, 2/15/2021, 2/18/2021, 2/19/2021, 2/20/2021, 2/21/2021, 2/22/2021, 2/23/2021, 2/24/2021 and 2/25/2021. Review of the skilled nursing notes on the following dates failed to evidence changing the inner cannula of the tracheostomy tube: 12/28/2021, 12/29/2021, 12/30/2021, 1/1/2021, 1/2/2021, 1/3/2021, 1/4/2021, 1/5/2021, 1/6/2021, 1/7/2021, 1/9/2021, 1/10/2021, 1/13/2021, 1/14/2021, 1/15/2021, 1/16/2021, 1/17/2021, 1/18/2021, 1/19/2021, 1/20/2021, 1/21/2021, 1/22/2021, 1/23/2021, 1/24/2021, 1/25/2021, 1/26/2021, 1/27/2021, 1/28/2021, 1/29/2021, 1/30/2021, 1/31/2021, 2/1/2021, 2/4/2021, 2/5/2021, 2/6/2021, 2/7/2021, 2/8/2021, 2/9/2021, 2/10/2021, 2/11/2021, 2/12/2021, 2/13/2021, 2/14/2021, 2/15/2021, 2/18/2021, 2/19/2021, 2/20/2021, 2/21/2021, 2/22/2021, 2/23/2021, 2/24/2021 and 2/25/2021. The subcategory "Orders and Treatments" also stated, " ... Notify physician of: Temperature greater than (>) or less than () 110 or less than () 24 or less than () 160 or less than () 90 or less than (<) 60...." This order failed to indicate how frequent vital signs were to be taken. During an interview on 3/4/2021 at 12:08 p.m., the clinical manager indicated vital signs should be checked on patient #4 every 4 hours at minimum. Review of the skilled nursing notes dated 1/9/2021, 1/10/2021, 1/24/2021, 2/6/2021, 2/7/2021, 2/20/2021, 2/21/2021, 2/24/2021, and 2/25/2021, each signed by employee E, RN [registered nurse], failed to evidence any patient blood pressures. 17-13-1(a)

G0574

G0590

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure relevant changes in the patient's plan of care were promptly alerted to the physician in 4 of 10 clinical records reviewed. (#7, #9, #5, #3) The findings include: 1. An undated agency policy, number 6.020.1, with a subject titled "Nurse Supervision" stated, "Purpose: To ensure that all daily operations and patient care are provided in a professional standard that meets state regulatory guidelines ... Policy: the agency's director of nursing, alternate director of nursing, and/or case manager are responsible for overseeing the clinical operations of patient care... 2. The DON will oversee all services that work under the licensure of the agency and provide in services on an ongoing basis to ensure agency compliance to state and federal regulations.... " 2. An undated agency policy, number 6.016.1, with a subject titled "Care Planning" stated, "..14. Clinicians will inform the patient's physician of any changes that suggest a need to alter the plan of care. Changes will be written, timed /dated, and signed by the qualified clinician and physician making the changes ... 18. If person to person contact was not completed or if awaiting a return response, all Contacts and interactions shall be documented. The agency shall have a written policy regarding how the agency will intervene if the attending care provider cannot be contacted or does not respond timely ..." 3. Clinical record review on 3/4/2021, for patient #7, start of care 4/5/2017, primary diagnosis of cerebral palsy, evidenced a document titled "Home Health Certification and Plan of Care" for certification period 11/15/2020 - 1/13/2021. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide up to 2 hrs [hours] per day, 7 days a week for 26 weeks ... Frequency and/or duration may be decreased if/when an available caregiver is present, willing, and able to assist .... " Record review evidenced an agency document titled "Missed Visit Form (HHA Visit)" which was digitally signed by HHA H, on 11/24/2020. This document stated "Reason: ... Other (Specify) ... Comments: ... [left blank] ... MD [doctor of medicine] Notified: ... No .... " Record review failed to evidence the patient's physician was notified of the deviation from the plan of care. During an interview on 3/4/2021, at 11:40 AM, the clinical manager indicated notification to the physician of the missed visit was not documented in the clinical record. 4. Clinical record review on 3/4/2021, for patient #9, start of care 10/30/2019, primary diagnosis of encephalopathy (disease which alters brain function), evidenced a document titled "Home Health Certification and Plan of Care" for certification period 6/26/2020 - 8/24/2020. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide up to 10 hours a day, up to 7 days a week for 26 weeks ... Frequency and/or duration may be decreased if/when an available caregiver is present, willing, and able to assist .... " Record review evidenced agency documents titled "Missed Visit Form (HHA Visit)" for the following dates: 8/5/2020, and 8/12/2020. These documents stated "Reason: ... Other (Specify) ... Comments: ... [left blank] ... MD Notified: ... No .... " Record review failed to evidence the patient's physician was notified of the deviation from the plan of care. During an interview on 3/4/2021, at 12:43 PM, the clinical manager indicated notification to the physician of the missed visit was not documented in the clinical record. 5. Clinical record review for patient #5 with start of care 8/31/2020, certification period 12/29/2021 to 1/29/2021, primary diagnosis of legal blindness, evidenced an agency document titled, "Missed Visit Form" dated 11/3/2020, signed by employee N. This note stated, " ... MD [medical doctor] Notified: No...." During an interview on 3/4/2021 at 11:50 a.m., the clinical manager indicated only skilled nurse missed visits were reported to the physician by the agency, not missed home health aide visits. 6. Clinical record review on 3/2/2021 for patient #3, start of care 2/17/2020, certification period 1/12/2021 to 3/2/2021, primary diagnosis of chronic obstructive pulmonary disease [a disease that causes long-term breathing problems], evidenced an agency document titled, "Missed Visit Form", dated 1/26/2021, signed by employee K, HHA [home health aide]. This form stated, " ... Reason: Cancellation of Care ... MD [medical doctor] Notified: Yes, by Phone. Physician: [person E, MD]...." Clinical record review evidenced an agency document titled, "Home Health Certification and Plan of Care", dated 12/28/2020 and signed by the clinical manager. This document had a subcategory titled, "Clinical Data" which stated, "Primary Physician [person B, MD]". During an interview on 3/4/2021 at 11:50 a.m., the clinical manager indicated person E was not the primary physician of patient #3. The patient's primary care physician, person B, was not notified of the missed visit. 17-13-1(d)

G0592

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the supervising nurse revised the plan of care to reflect the current frequencies that were provided in 2 of 10 clinical records reviewed. (#7, #10) The findings include: 1. An undated agency policy number 4.004.1, with a subject subtitled "Physician Orders/Plan of Care" stated, "Purpose: To ensure that each patient's care is under the direction of a physician ... Policy: the physician establishes and reviews a plan of treatment for the patient. The plan is updated and maintained as part of the agency's clinical record ... Procedure: 1. the physician sets up a plan of care, which includes the diagnosis, prognosis, goals to be accomplished, an order for each service, an item of drugs and equipment to be provided by the agency. 2. All orders on the CMS 485 will be specific to the client condition in needs ... 7. The physician and appropriate professional staff will review and recertify the written plan of care at least once per episode and as warranted by the patient's condition... 9. The agency's professional staff will review the clinical records on a continuous basis to ensure each POC is specific to the patient and that additional orders for services are present in the clinical record .... " 2. Clinical record review on 3/4/2021, for patient #7, start of care 4/5/2017, primary diagnosis of cerebral palsy, evidenced a document titled "Home Health Certification and Plan of Care" for certification period 1/14/2021 - 3/14/2021. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide up to 2 hrs [hours] per day, 7 days a week for 26 weeks ... Frequency and/or duration may be decreased if/when an available caregiver is present, willing, and able to assist .... " Record review evidenced this patient received care for 2 hours per day, 3 days a week since 12/14/2020. Record review failed to evidence the plan of care was revised as needed. During an interview on 3/4/2021, at 11:32 AM, the clinical manager indicated the reason this patient did not receive the hours as ordered on the plan of care, is due to Person D, caregiver for patient #7. It is their preference to only utilize HHA D to furnish care on behalf of the agency. 3. Clinical record review on 3/4/2021, for patient #10, start of care 2/26/2019, primary diagnosis of progressive mutifocal leukoenchalopathy (disease of the white matter of the brain), evidenced a document titled "Home Health Certification and Plan of Care" for certification period 12/17/2020 - 2/14/2021. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide 4 hours a day, 7 days a week ... Frequency and/or duration may be decreased if/when an available caregiver is present, willing, and able to assist .... " Record review evidenced this patient received care for 6 hours a day, 7 days a week since 12/17/2020. Record review failed to evidence the plan of care was revised as needed. During an interview on 3/4/2021, at 1:07 PM, the clinical manager indicated the duration stated on the plan of care was an oversight, and should written as 6 hours per day. 17-14-1(a)(1(C)

G0598

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any). This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure discharge plans were communicated to the patient and patient's physician for 2 of 3 discharged patients, in a total sample of 8 clinical records reviewed. (#6, #9) The findings include: 1. An undated agency policy number 4.003.2, with a subject subtitled "Client Records" stated, "... z. discharge summary with the agency's documented notice to the client, the client's physician and other individuals as needed that also includes: ... The care or services provided; the course of care and services; the reason for discharge or transfer; the name of the person receiving transfer report, date and time of report; the transfer of orders and instructions; the status of the patient at time of discharge .... " 2. An undated agency policy number 3.001.1, with a subject subtitled "Client Conduct, Responsibility and Rights" stated, "...The agency will advise you of changes, including the termination of services orally and in writing as soon as possible, but no later than fifteen (15) calendar days from the date that the agency becomes aware of a change. If an agency is changing /deleting /adding services or implementing a scheduled rate increase to all patients, the agency shall provide a written notice to each affected customer at least 30 days before implementation ... " 3. Clinical record review on 3/4/2021, for patient #6, start of care 6/21/2019, failed to evidence the patient was notified in writing of the discharge date on 3/16/2020. During an interview on 3/4/2021, at 11:24 AM, the clinical manager indicated patient #6 did not receive a discharge notice because the patient was difficult to get a hold of. They added the patient indicated wanting to go "somewhere warmer" and did not think to send a certified letter to the patient's home. 4. Clinical record review on 3/4/2021, for patient #9, start of care 10/30/2019, evidenced a letter to Person F, patient #9's caregiver, which was signed by the administrator and clinical manager on 7/29/2020. This letter stated "[Patient #7]'s physician, [Person G] has been made aware of the situation and will be updated when [his/her] services are transferred and discharged ... As a measure of good will, we will set your discharge date 30 days from the date of our conversation which will be August 24, 2020. ... " Record review failed to evidence the patient's physician was notified of the discharge on 8/24/2020. During an interview on 3/4/2021, at 12:41 PM, the clinical manager indicated physician notification of the patient's discharge was not documented in the clinical record.

G0606

G0614

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure patients were provided a written schedule of visits in 3 of 3 home visits out of a total sample of 10 patient records reviewed (#2, #3, #7). The findings include: 1. Record review on 3/2/2021 evidenced an agency policy titled, "Client Conduct, Responsibility and Rights", number 3.001.1, which stated, " ... the agency must inform a patient and/or patient representative orally and in writing of the following: ... 7. The nature and frequency of services to be delivered ... Patient Rights ... 17. Know when and how each service will be provided...." 2. During a home visit for patient #2 on 2/26/2021 at 9:55 a.m. failed to evidence a written schedule of visits from the agency. 3. During a home visit for patient #3 on 3/1/2021 at 12:00 p.m. failed to evidence a written schedule of visits from the agency. During an interview on 3/3/2021 at 3:55 p.m., the administrator indicated the agency failed to ensure patients received a written schedule of visits from the agency.4. During a home visit for patient #7 on 2/26/2021, failed to evidence a written schedule of visits from the agency.

G0616

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation and interview, the agency failed to ensure patients were provided a current written patient medication list in 3 of 3 home visits conducted (#2, #3, #7). The findings include: 1. During a home visit for patient #2 on 2/26/2021 at 9:55 a.m., failed to evidence a current patient medication list provided by the agency. During an interview on 2/26/2021 at 11:08, person C, caregiver to patient #2, indicated the agency did not provide her a current patient medication list. 2. During a home visit for patient #3 on 3/1/2021 at 12:00 p.m., failed to evidence a current patient medication list provided by the agency. During an interview on 3/3/2021 at 4:02 p.m., the clinical manager indicated a medication list was part of the patient's home folder. When informed of the findings, the clinical manager stated, "OK". 3. During an home visit for patient #7 on 2/26/2021, failed to evidence a current medication list was provided by the agency.

G0768

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure each home health aide (HHA) completed a competency evaluation prior to furnishing home health services for 1 of 4 HHA's, in a total sample of 8 personnel records reviewed. (employee H) The findings include: 1. An undated agency policy, number 2.009.1, with a subject subtitled "Competency Evaluations" stated, "Purpose: To assess competency of all field staff ... Policy: Newly hired and experienced field staff must demonstrate competency within the job description that applies to that staff member, prior to be permitted direct contact with patients... Testing may be used to assess competencies. Skills checklist may also be used in conjunction with testing ... Procedure: 1. All field staff must be evaluated for competency with relation to their job description prior to receiving patient assignments and prior to performing new tasks ... 2. Written tests are one method of evaluation it may be used in coordination with skills checklists ... 5. ... Competency will be determined prior to allowing the aid to work in dependently. Proof of competency will be kept in the employee's personnel file ... The minimum competency required for each job will be evaluated and a competency test given. This will be documented in the employee personnel file .... " 2. Personnel record review on 3/3/2021, for HHA H evidenced a first patient contact date of 4/9/2021. Record review failed to evidence HHA H completed a competency evaluation prior to patient contact. During an interview on 3/3/2021, at 3:44 PM, the clinical manager indicated there was no explanation for why the competency exam was not in HHA H's personnel file. 17-14-1(l)(A)

G0798

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 agency failed to ensure the registered nurse provided a complete care plan for the home health aide [HHA] in 3 out of a total sample of 10 clinical records reviewed (#2, #3, #6). The findings include: 1. Record review on 3/2/2021 evidenced an agency policy titled, "Registered Nurse", number 6.020.2, which stated, " ... The RN [registered nurse] will make home health aide assignments, prepare written instructions for the aide, and supervise the aide in the home...." 2. Clinical record review on 3/2/2021 for patient #2, start of care 8/13/2020, certification period 12/11/2020 to 2/8/2021, primary diagnosis of Multiple Sclerosis, evidenced an agency document titled, "Home Health Certification and Plan of Care", signed by the physician on 2/27/2021. This plan of care evidenced a subcategory titled, "Medications". This subcategory stated, "Apixaban [a blood thinner] Oral 5 mg [milligram] 1 tab (s) Take one tablet by mouth two times daily ... Aspirin [a pain and fever reducer and blood thinner] Oral 81 mg 1 tab (s) Take one tablet by mouth daily...." Clinical record review evidenced an agency document titled, "Aide Care Plan", dated 12/11/2020 and signed by the clinical manager. This care plan failed to evidence Bleeding Precautions. During an interview on 3/4/2021 at 11:00 a.m., the clinical manager indicated Bleeding Precautions should be included in the Aide Care Plan for a patient taking blood thinners. During a home visit for patient #2 on 2/26/2021 at 9:30 a.m., the patient was observed to have a PEG tube [a feeding tube directly inserted to the stomach through the abdomen], and a Wound VAC [vacuum-assisted closure][a device used to assist wound healing]. Review of the Aide Care Plan failed to evidence any HHA duties related to the PEG tube and Wound VAC. During an interview on 3/4/2021 at 11:05 a.m., the clinical manager indicated the Aide Care Plan for a patient with a PEG tube and a Wound VAC should include instruction for the aide not to use the PEG tube, to follow aspiration precautions, to use extra caution when turning or moving the patient, and proper positioning with these devices. The clinical manager indicated she failed to include these instructions in the Aide Care Plan. 3. Clinical record review on 3/2/2021 for patient #3, start of care 2/17/2020, certification period 1/12/2021 to 3/2/2021, primary diagnosis of chronic obstructive pulmonary disease [a disease that causes long-term breathing problems], evidenced an agency document titled, "Home Health Certification and Plan of Care". This plan of care had a subcategory titled "Medications", which stated, " ... Eliquis [a blood thinner] Oral 2.5 mg [milligram] 1 tab(s) Take one tablet by mouth twice a day...." Clinical record review evidenced an agency document titled, "Aide Care Plan", dated 1/2/2021 and signed by the clinical manager. This care plan failed to evidence Bleeding Precautions. During an interview on 3/4/2021 at 11:00 a.m., the clinical manager indicated Bleeding Precautions should be included in the Aide Care Plan for a patient taking blood thinners. Review of the plan of care evidenced a subcategory titled "Patient Risk Profile", which stated, "Risk Factors: History of falls (2 or more falls - or any fall with an injury - in the past 12 months)...." The plan of care also contained a subcategory titled, "Safety Measures", which stated, "Keep Pathway Clear ... Slow Position Change ... Support During Transfer and Ambulation ... Safety in ADLs [activities of daily living] ... Fall Precautions...." Review of the Aide Care Plan failed to evidence fall prevention or safety precautions. When informed of the findings on 3/4/2021 at 11:55 a.m., the clinical manager stated, "OK", and offered no further documentation. 4. Clinical record review on 3/4/2021, for patient #6, start of care 6/21/2019, failed to evidence a home health aide care plan had been established by the supervising nurse for certification period 2/16/2020 - 4/15/2020. During an interview on 3/4/2021, at 11:23 AM, the clinical manager indicated the lack of the patient's home health aide care plan was an oversight which was probably due to the patient being admitted during the agency's administrative change. 17-14-1(m)

G0814

Non-skilled direct observation every 60 days CFR(s): 484.80(h)(2) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, the registered nurse must make an on-site visit to the location where the patient is receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure an on-site home health aide (HHA) supervision was conducted at least every 60 days for 2 of 10 clinical records reviewed. (#7, #5) The findings include: 1. An undated agency policy, number 6.020.1, with a subject titled "Nurse Supervision" stated, "Purpose: To ensure that all daily operations and patient care are provided in a professional standard that meets state regulatory guidelines ... 7. Home health aides will be supervised at least every 30 days by a RN [registered nurse] for non-skilled care .... " 2. Clinical record review on 3/4/2021, for patient #7, start of care 4/5/2017, primary diagnosis of cerebral palsy, evidenced a document titled "Home Health Certification and Plan of Care" for certification period 1/14/2021 - 3/14/2021. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide up to 2 hrs [hours] per day, 7 days a week for 26 weeks .... " Record review failed to evidence HHA supervisory visits were completed as required, dating back to 11/15/2020. During an interview on 3/4/2021, at 11:41 AM, the clinical manager indicated the HHA supervisory visits were not in the documented clinical record. 3. Clinical record review for patient #5 with start of care 8/31/2020, certification period 12/29/2021 to 1/29/2021, primary diagnosis of legal blindness, evidenced an agency document titled, "Home Health Certification and Plan of Care". This plan of care had a subcategory titled, "Orders and Treatments" which stated, " ... Home Health Aide requesting to provide 6 (up to 12) hours a day, 5 days a week; based on patient need/request...." Review of patient #5's electronic medical record from start of care (8/31/2020) to discharge (1/29/2021), failed to evidence any home health aide supervisory visits completed. During an interview on 3/4/2021 at 12:25 p.m., the clinical manager indicated home health aide supervisory visits should have been done every 30 days for patient #5.

G0818

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure each home health aide (HHA) followed the care plan as assigned in 4 of 10 clinical records reviewed. (#7, #8, #10, #5) The findings include: 1. An undated agency policy, number 6.021.1, with a subject titled "Home Health Aide" stated, "... Procedure: the home health aide shall have the following responsibilities: ... 1. Provide services that are ordered by the physician in the plan of care, only those services written in the plan of care and received as written instructions from the registered nurse supervisor as permitted under State law... 2. Home Health Aide Training... c. A home health aide is assigned to a particular patient by a registered nurse ... d. Written instructions for home care, including specific exercises, are prepared by a registered nurse or therapist as appropriate. Aide instructions are written in relation to the patient's plan of care and within the duties allowed to be permitted by a nurse aide.... " 2. Clinical record review on 3/4/2021, for patient #7, start of care 4/5/2017, primary diagnosis of cerebral palsy, evidenced documents titled "Home Health Certification and Plan of Care" for certification periods 11/15/2020 - 1/13/2021, and 1/14/2021 - 3/14/2021. These documents had an area subtitled "Orders and Treatments" which stated, "Home health aide duties may include but are not limited to: personal hygiene care, bathing, dressing, turning/positioning, assistance with wound prevention, incontinent care, checking integumentary [skin] status, and light housekeeping .... " Record review evidenced agency documents titled "Aide Care Plan" for the periods 11/15/2020 - 1/13/2021, and 1/14/2021 - 3/14/2021. These documents stated "Elimination ... Record bowel movement ... per visit ... Additional Comment ... Home health aides are to check temperature per visit during Covid-19 pandemic and report if not WNL [within normal limits] .... " Record review of the agency documents titled "HHA Visit" failed to evidence the patient's temperature was documented on the following dates: 12/9/2020, 12/11/2020, 12/14/2020, 12/16/2020, 12/18/2020, 12/21/2020, 12/23/2020, 12/25/2020, 12/28/2020, 12/30/2020, 1/1/2021, 1/18/2021, 1/20/2021, 1/22/2021, 1/25/2021, 1/27/2021, 1/29/2021, 2/1/2021, 2/3/2021, 2/5/2021, 2/8/2021, 2/10/2021, 2/11/2021, 2/17/2021, 2/19/2021, 2/22/2021, 2/24/2021, 2/26/2021, and 3/1/2021. Record review of the agency documents titled "HHA Visit" failed to evidence the patient's last bowel movement was documented on the following dates: 11/23/2020, 11/24/2020, 11/25/2020, 11/30/2020, 12/6/2020, 12/18/2020, 12/21/2020, 12/23/2020, 12/25/2020, 12/28/2020, 12/30/2020, 1/1/2021, 1/18/2021, 1/20/2021, 1/22/2021, 1/25/2021, 1/27/2021, 1/29/2021, 2/1/2021, 2/3/2021, 2/5/2021, 2/8/2021, 2/10/2021, 2/11/2021, 2/17/2021, 2/19/2021, 2/22/2021, 2/24/2021, 2/26/2021, and 3/1/2021. During an interview on 3/4/2021, at 11:37 AM, the clinical manager and administrator were informed of the dates and tasks that not documented on the HHA Visit notes. The clinical manager replied, "Okay." 3. Clinical record review on 3/4/2021, for patient #8, start of care 6/10/2019, primary diagnosis of hemiplegia [weakness or paralysis on one side of the body], evidenced a document titled "Home Health Certification and Plan of Care" for certification period 12/1/2020 - 1/292021. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide duties may include but are not limited to: personal hygiene care, bathing/showering, assisting with transfers, turning/positioning, assistance with wound prevention, foley [urinary catheter] care, ostomy [colostomy, surgical opening in the abdominal wall to bypass a damaged part of the colon] care, checking integumentary status, medication assistance and reminders, meal preparations, and light housekeeping .... " Record review evidenced an agency document titled "Aide Care Plan" for the period 12/1/2020 - 1/29/2021. This document stated "Elimination ... Catheter Care ... per visit ... Empty Ostomy Bag ... per visit ... Activity ... Assist in Transfer ... per visit ... Turn or Position ... per visit ... Household ... Change Linen ... Wednesday visit and when soiled ... Light Housekeeping ... per visit ... Make Bed ... per visit ... Personal Care ... Check Pressure Areas ... per visit ... Oral Hygiene Denture Care ... per visit assist .... " Record review of the agency documents titled "HHA Visit" failed to evidence the patient's colostomy was emptied and documented on the following dates: 12/5/2020, 12/6/2020, 12/9/2020, 12/10/2020, 12/13/2020, 12/17/2020, 12/30/2020, 12/25/2020, 12/28/2020, 12/30/2020, and 1/5/2021. Record review of the agency documents titled "HHA Visit" failed to evidence the patient's bed was made on the following dates: 12/3/2021, 12/4/2021, 12/5/2020, 12/6/2020, 12/7/2021, 12/8/2021, 12/9/2020, 12/10/2020, 12/11/2021, 12/12/2021, 12/15/2020, 12/16/2020, 12/17/2020, 12/18/2020, 12/19/2020, 12/20/2020, 12/21/2020, 12/22/2020, 12/23/2020, 12/23/2020, 12/24/2020, 12/25/2020, 12/26/2021, 12/27/2020, 12/29/2020, 1/1/2021, 1/2/2021, 1/3/2021, 1/4/2021, 1/5/2021, 1/6/2021, 1/7/2021, 1/8/2021, 1/9/2021, 1/10/2021, 1/12/2021, 1/13/2021, 1/14/2021, 1/16/2021, 1/17/2021, 1/19/2021, 1/20/2021, 1/21/2021, 1/23/2021, 1/24/2021, 1/26/2021, 1/27/2021, and 1/29/2021. Record review of the agency documents titled "HHA Visit" failed to evidence the patient received catheter care on the following dates: 12/11/2021, 12/17/2020, 12/22/2020, 12/27/2020, 1/21/2021, and 1/27/2021. Record review of the agency documents titled "HHA Visit" failed to evidence the patient's linens were changed on the following Wednesdays: 12/23/2021, 12/30/2020, 1/6/2021, 1/13/2021, and 1/20/2021. Record review of an agency document titled "HHA Visit" from 12/22/2020, which was digitally signed by HHA L. This document failed to evidence denture care and pressure ulcer check was performed. Record review of an agency document titled "HHA Visit" from 1/21/2021, which was digitally signed by HHA L. This document failed to evidence light housekeeping, assist with transfers, and turns/reposition was performed. During an interview on 3/4/2021, at 11:46 AM, the administrator and clinical manager were informed of the dates and tasks that were not documented on the HHA careplan. The clinical manager stated, "Thank you" in response. 4. Clinical record review on 3/4/2021, for patient #10, start of care 2/26/2019, primary diagnosis of progressive mutifocal leukoenchalopathy (disease of the white matter of the brain), evidenced a document titled "Home Health Certification and Plan of Care" for certification period 12/17/2020 - 2/14/2021. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide duties may include but are not limited to: personal hygiene care, bathing/showering, assisting with ambulation, assisting with transfers, turning/positioning, assistance with wound prevention, incontinent care, checking integumentary status, medication assistance and reminders, meal preparations and light housekeeping .... " Record review evidenced an agency document titled "Aide Care Plan" for the period 12/17/2020 - 2/14/2014, which stated "Additional Comment ... Home health aides are to check temperature per visit during Covid-19 pandemic and report if not WNL .... " Record review of the agency documents titled "HHA Visit" failed to evidence the patient's temperature was documented on the following dates: 12/17/2020, 12/19/2020, 12/21/2020, 12/22/2020, 12/25/2020, 12/26/2020, 12/28/2020, 12/30/2020, 12/31/2020, 1/2/2021, 1/3/2021, 1/4/2021, 1/5/2021, 1/6/2021, 1/7/2021, 1/8/2021, 1/9/2021, 1/10/2021, 1/11/2021, 1/12/2021, 1/13/2021, 1/14/2021, 1/15/2021, 1/16/2021, 1/17/2021, 1/18/2021, 1/19/2021, 1/20/2021, 1/21/2021, 1/22/2021, 1/23/2021, 1/24/2021, 1/25/2021, 1/26/2021, 1/27/2021, 1/28/2021, 1/29/2021, 1/30/2021, 1/31/2021, 2/1/2021, 2/2/2021, 2/3/2021, 2/4/2021, 2/5/2021, 2/6/2021, 2/7/2021, 2/8/2021, 2/9/2021,2/10/2021, 2/11/2021, 2/12/2021, 2/13/2021, and 2/14/2021. On 3/4/2021, at 1:06 PM, the administrator and clinical manager were notified of dates the patient's temperature was not evidenced in the clinical record. 5. Clinical record review for patient #5 with start of care 8/31/2020, certification period 12/29/2021 to 1/29/2021, primary diagnosis of legal blindness, evidenced an agency document titled, "Aide Care Plan", dated 12/29/2020 and signed by the clinical manager. This document had a subcategory titled "Additional Comment", which stated, " ... Home Health Aide to assist patient with reminders to complete prescribed neck exercises ... patients temperature should be taken before starting care during Covid-19 pandemic...." Clinical record review evidenced a group of agency documents titled "HHA [home health aide] Visit". Review of the HHA visit notes from the following dates failed to evidence patient reminders to complete prescribed neck exercises: 12/29/2020, 12/30/2020, 12/31/2020, 1/4/2021, 1/10/2021, 1/11/2021, 1/13/2021, 1/15/2021, 1/18/2021, 1/19/2021, 1/22/2021, 1/25/2021, 1/26/2021, and 1/28/2021. Review of the HHA visit notes from the following dates failed to evidence a patient temperature: 12/29/2020, 12/30/2020, 12/31/2020, 1/4/2021, 1/11/2021, 1/14/2021, 1/18/2021, 1/19/2021, 1/25/2021. During an interview on 3/4/2021 at 12:26 p.m., the clinical manager indicated the patient's temperature should be recorded daily on each HHA visit note. Review of the HHA visit notes from 1/10/2021, 1/15/2021, 1/25/2021 and 1/28/2021, signed by employee M, HHA, failed to evidence completion of any assigned tasks. When informed of the findings, the clinical manager reviewed the note from 1/28/2021 and stated, "That is an incorrect note". 17-14-1(n)

G1024

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all clinical record entries were legible, clear, complete, and appropriately authenticated in 5 out of 10 total patient records reviewed (#1, #2, #3, #7, #9) The findings include: 1. Record review on 3/2/2021 evidenced an agency policy titled, "Timeliness and Accuracy of Entries in the Clinical Record", number 4.003.1. This policy stated, "Purpose: To ensure that a current and accurate clinical record exists for each patient and to ensure documents are filed in the client's records in a timely manner. Policy: Each entry into the client record must be current, accurate, signed, legible, and dated with the date of entry by the individual making the entry. Documents must be filed into the client record timely and according to regulations and retrievable during operating hours. Procedure: 1. Complete clinical progress notes on the date service is rendered. Progress notes are to be recorded in Kinnser/WellSky Software [electronic medical record] no later than 14 days from the completion of the visit...." 2. Clinical record review on 3/2/2021 of the electronic medical record for patient #1, start of care 12/26/2013, certification period 1/18/2021 to 3/18/2021, primary diagnosis of quadriplegia [paralysis from the neck down], evidenced a calendar of visits. This calendar indicated the skilled nurse visits on the following dates were not yet started: 1/31/2021, 2/2/2021, 2/4/2021, 2/6/2021, 2/8/2021, 2/10/2021, 2/12/2021 and 2/14/2021. During an interview on 2/25/2021 at 11:54 a.m., the clinical manager indicated staff had 48 hours to enter documentation following a patient visit. During an interview on 3/4/2021 at at 10:44, the clinical manager indicated the skilled nurse visits were made on 1/31/2021, 2/2/2021, 2/4/2021, 2/6/2021, 2/8/2021, 2/10/2021, 2/12/2021 and 2/14/2021, but the nurse had not submitted documentation. Clinical record review evidenced a group of documents titled, "LPN [licensed practical nurse] / LVN [licensed vocational nurse] - Skilled Nursing Visit". The visit notes dated 1/19/2021, 1/21/2021, 1/31/2021, 2/2/2021, 2/6/2021, 2/8/2021, 2/10/2021, 2/16/2021, and 2/20/2021, signed by employee, F, LPN, contained a document titled, "Wound Care Worksheet". The area titled, "Comments", of this worksheet stated, " ... Ointment applied to coccyx [tailbone] area." The documentation failed to indicate what ointment the nurse applied. Clinical record review evidenced an agency document titled, "Home Health Certification and Plan of Care", signed by the physician on 3/2/2021. This plan of care had a subcategory titled, "Medications" which stated, " ... Desitin Maximum Strength External 40% thin layer Apply thin layer to affected area PRN [as needed] ... Bacitracin External [a topical antibiotic ointment] 500 unit / gm [gram] 1 apply to affected area as needed (SN to administer PRN) ... Santyl External [an ointment to help heal wounds] 250 unit / gm 1ml daily PRN (SN to administer PRN)...." During an interview on 3/4/2021 at 10:52 p.m., when informed of the findings, the clinical manager stated about the nurse's documentation, "we don't know what she used". The clinical manager indicated the skilled nurse should have documented specifically which topical medication was applied to the patient. 3. Clinical record review on 3/2/2021 for patient #2, start of care 8/13/2020, certification period 12/11/2020 to 2/8/2021, primary diagnosis of Multiple Sclerosis, evidenced a group of agency documents titled, "Missed Visit Form". A missed visit form dated 12/31/2020, signed by employee C, HHA [home health aide], stated, " ... Reason: Other (Specify) Comments: Approved day off...." The note failed to evidence a reason why the visit was missed. When informed of the findings, the clinical manager stated, "That's totally inappropriate". Missed visit notes dated 1/16/2021 and 1/30/2021 both stated, " ... Reason: Cancellation of Care...." During an interview on 3/4/2021 at 11:10 a.m., the clinical manager indicated all missed visit notes should include a reason for why the visit was missed. When informed of the findings, the clinical manager indicated the statement, "Cancellation of Care", failed to indicate who canceled the care and for what reason. 4. Clinical record review on 3/2/2021 for patient #3, start of care 2/17/2020, certification period 1/12/2021 to 3/2/2021, primary diagnosis of chronic obstructive pulmonary disease [a disease that causes long-term breathing problems], evidenced an agency document titled, "Missed Visit Form", dated 1/26/2021, signed by employee K, HHA [home health aide]. This form stated, " ... Reason: Cancellation of Care ... MD [medical doctor] Notified: Yes, by Phone. Physician: [person E, MD]...." Clinical record review evidenced an agency document titled, "Home Health Certification and Plan of Care", dated 12/28/2020 and signed by the clinical manager. This document had a subcategory titled, "Clinical Data" which stated, "Primary Physician [person B, MD]". During an interview on 3/4/2021 at 11:50 a.m., the clinical manager indicated person E was not the primary physician of patient #2. The clinical manager stated, "They [the HHA's] shouldn't be calling the doctor. It shouldn't even say that." When informed of the findings, the clinical manager indicated the statement, "Cancellation of Care", failed to indicate who canceled the care and for what reason. 5. Clinical record review on 3/4/2021, for patient #7, start of care 4/5/2017, primary diagnosis of cerebral palsy, evidenced a document titled "Home Health Certification and Plan of Care" for certification period 11/15/2020 - 1/13/2021. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide up to 2 hrs [hours] per day, 7 days a week for 26 weeks ... Frequency and/or duration may be decreased if/when an available caregiver is present, willing, and able to assist .... " Record review evidenced an agency document titled "Missed Visit Form (HHA Visit)" which was digitally signed by HHA H, on 11/24/2020. This document stated "Traveled to Patient: No ... Reason: Other (Specify) ... Comments: ... [left blank] ... MD [doctor of medicine] Notified: No ... Supervisor Notified: Yes, by Fax ...." Record review failed to evidence who canceled the patients care or an indication why. 6. Clinical record review on 3/4/2021, for patient #9, start of care 10/30/2019, primary diagnosis of encephalopathy (disease which alters brain function), evidenced a document titled "Home Health Certification and Plan of Care" for certification period 6/26/2020 - 8/24/2020. This document had an area subtitled "Orders and Treatments" which stated, "Home health aide requesting to provide up to 10 hours a day, up to 7 days a week for 26 weeks ... Frequency and/or duration may be decreased if/when an available caregiver is present, willing, and able to assist .... " Record review evidenced agency documents titled, "Missed Visit Form (HHA Visit)" digitally signed by HHA O, from the following dates: 7/2/2020, 8/5/2020, and 8/12/2020. These documents stated "Traveled to Patient: No ... Reason: Cancellation of Care ... Comments: ... [left blank] ... MD Notified: No ... Supervisor Notified: No .... " Record review failed to evidence who canceled the patients care or an indication why. 17-15-1(a)(7)

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