Every finding on record at Saint Luke's Health System Home Care and Hospice

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 06/25/2024.During the survey it was determined the home health provider is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Providers.

A partial extended survey for Medicare recertification for the home health provider was completed on 06/25/2024. The provider had 833 current patients.

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 policy review, clinical record review, and interview, the home health provider failed to ensure the individualized plan of care contained the types of services, supplies, and equipment required to meet the needs of their patients in two of five records reviewed (Records/Patients #2 and #4). This deficient practice has the potential to affect the care for all of the provider’s patients. Findings included: Review of the provider’s policy titled, “Care Planning (Plan of Care),” last revised 12/17/2024, showed all orders or service and/or products will be incorporated into the plan of care. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted on 05/28/2024 with a diagnosis of atrial fibrillation (abnormal heart rhythm characterized by rapid and irregular heartbeat), and a new diagnosis of type 2 diabetes (a group of diseases that results in too much sugar in the blood) on 05/18/2024. Review of the start of care, comprehensive nursing assessment visit documentation, for the visit performed 05/28/2024, showed that the patient: - Had a non-removeable dressing on their right hip; - Was not performing blood sugar monitoring; and - Had diagnoses of right hip arthroplasty (a surgical procedure that improves joint function and pain by repairing or replacing a damaged joint) following a recent fall and atrial fibrillation. Review of the plan of care dated 05/28/2024, failed to show: - Information that the patient had undergone a right hip arthroplasty on or around 05/12/2024; and - Interventions to monitor or address the new diagnosis of type two diabetes. During an interview on 06/25/2024 at 3:46 PM, the administrator stated that they would expect the right hip arthroplasty and interventions to monitor a newly diagnosed diabetic to be included on the plan of care. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted on 05/26/2024 following a hospital stay for treatment of a urinary tract infection. The patient had a history of pressure injuries (wounds), chronic respiratory failure (a condition that occurs when the lungs cannot exchange oxygen and carbon dioxide properly, resulting in low oxygen levels or high carbon dioxide levels in the blood), and oxygen dependence. The patient resided in their own home with the assistance of their spouse. Review of the start of care, comprehensive nursing assessment visit documentation, for the visit performed on 05/26/2024, showed the patient: - Used a Purewick system (an external urine collection system to manage urinary incontinence) for management of urinary incontinence; and - Used oxygen at 4 (four) liters per minute. Review of the physical therapy evaluation visit documentation, for the visit performed on 05/30/2024, showed the patient: - Used a Luisa system (a home ventilator system); and - Someone in the home was a smoker. Review of the occupational therapy evaluation visit documentation, for the visit performed on 05/31/2024, showed the patient was using oxygen at 6 (six) liters per minute. Review of the plan of care, with start of care date 05/26/2024, failed to contain orders and interventions for: - The use of the Purewick or Luisa systems; - The reason for an oxygen range of 4 to 6 liters per minute; and - Safety measures associated with having a smoker in the home with concurrent oxygen therapy. During an interview on 06/25/2024 at 4:16 PM, the administrator stated that they would expect the plan of care to contain orders and interventions for: - The use of the Purewick or Luisa systems; - The reason for an oxygen range of 4 to 6 liters per minute; and - Safety measures associated with having a smoker in the home with concurrent oxygen therapy.

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 policy review, home visit observation, and interview, the home health provider failed to ensure staff followed the bag technique procedure in one of three home visits (Record/Patient #1). This deficient practice has the potential to affect all the provider’s patients. Findings included: Review of the provider’s policy titled, “Bag Technique,” last reviewed 03/31/2021 showed, “Hand washing equipment should be kept on the outside pockets or dirty area of the bag. Wash hands before entering the bag and upon returning for any reason.” RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted on 02/16/2024 for a primary diagnosis of a pressure ulcer (wound) of the right lower leg. The patient resided alone in his/her own home. Observation on 06/24/2024 at 3:53 PM, during the patient’s home visit, showed the clinician: - Performed hand hygiene and donned nonsterile gloves; - Entered the clinical bag and retrieved the blood pressure cuff; - Placed the blood pressure cuff on the patient, and assisted the patient in signing the tablet; - Failed to remove their soiled gloves prior to re-entering the clinical bag to retrieve the pulse ox and thermometer; - Measured the patient’s temperature and pulse oximetry reading; - Failed to perform hand hygiene and continued to wear soiled nonsterile gloves; - Cleansed the blood pressure cuff, thermometer, and pulse oximeter using cleansing wipes; - Failed to perform hand hygiene and continued to wear soiled nonsterile gloves; and - Returned the ‘cleaned’ equipment into the clinical bag. During an interview on 06/25/2024 at 3:41 PM, the administrator stated they would expect the clinician to perform hand hygiene prior to re-entering the clinical bag.

The Emergency Preparedness regulations were reviewed as part of the Medicare certification survey completed on 11/18/2021. During the survey it was determined Saint Lukes Home Care is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Agencies.

An extended survey for Medicare certification for Saint Lukes Home Care was completed on November 18, 2021. The agency had 782 current patients. One condition-level deficiency was identified during this survey. A condition level deficiency is identified at 484.55 Condition of Participation: Comprehensive assessment of patients. A home health agency that is found out of compliance with certain Conditions of Participation evaluated as part of an extended survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at 484.80(f) (3) - see Tag G788. A Covid 19 Focused Infection Control Survey was completed in conjunction with the survey with one deficiency identified related to the Focused Infection Control Survey.

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 review of the agency's current patient rights information, and interview, the agency failed to ensure staff provided the written notice of the updated state toll free home health telephone hotline hours of operation (7:00 AM to 8:00 PM, seven days a week) in the admission booklet. This deficient practice has the potential to adversely affect the patient's knowledge and comprehension of the rights and responsibilities of all the agency's patients. Findings included: The agency provided the current, pre-printed, admit booklet and inserts for review on 11/15/2021. The agency notice of patient rights and other information given to a patient during the initial visit showed inaccurate information regarding the toll free hotline number hours of operation. Page 8 of the admission booklet showed the hotline hours listed as 7:00 AM to 12:00 AM, seven days a week. The findings were reviewed with the director on 11/17/2021 at 9:10 AM. The director was unaware of the hotline hour time change.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on review of the agency's current patient rights information and interview, the agency failed to update the written notice of patient rights to meet the requirements of the federal home health regulations to include the name, address and phone number of the current Quality Improvement Organization (QIO) that serves the area where the patient resides. This deficient practice has the potential to adversely affect all patients served by the agency. Findings included: The agency provided the current, pre-printed, admit booklet and inserts for review on 11/15/2021. The agency notice of patient rights and other information given to a patient during the initial visit failed to include the current QIO organization. The agency listed TMF Health Quality Institute as the current QIO organization for their area. The current QIO for this patient's area is Livanta LLC. During an interview on 07/17/2021 at 9:10 AM, the director was unaware of the current QIO organization. .

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on review of the Conditions of Participation’s interpretive guidelines, policy review, record review, home visit observation, and interview, the agency failed to assure all patients received a complete comprehensive assessment that provided the home health agency with a complete picture of the patient’s status to assist the HHA (home health agency) in developing the patient’s plan of care, including but not limited to, assessment of the patient’s current psychosocial status including screening of the patient’s relationships and living environment (G528). The seriousness of this deficient practice has the potential to adversely affect the provision of safe care of all the patients served by the agency.

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 the Conditions of Participation interpretive guidelines, agency policy review, clinical record review, observation, and interview, the agency failed to ensure the patient's current health needs and psychosocial status was assessed and documented in one (Patient/Record #1) of five records reviewed. This deficient practice has the potential to adversely affect the identification of patient needs and the provision of safe care for this patient and all patients on service with the agency. Findings included: Review of the agency’s policy titled, “Comprehensive Patient Assessment,” effective date of 4/5/2019 showed, in part: - To develop a database which will be used to determine the appropriate care, treatment and services to meet client initial needs and their changing needs; - To collect data about the client’s health history (physical, function and psychological) and their needs as appropriate to the home care setting; - To identify problems and needs of the patients; - To measure processes of care in the agency; - The comprehensive assessment will include, but not limited to, living arrangements and assessment of home environment and suitability for providing care in the home; - The comprehensive assessment will be performed using the following, but not limited to, strategies as appropriate: * Interview; * Interaction; * Direct observation; and * Inspection. - A comprehensive assessment shall be conducted by each service discipline prior to initiating service for that discipline; - Patient needs are assessed and care guidelines established based on the assessment data; - The scope and intensity of further assessment will be determined by the patient’s diagnosis, condition, need and desire for care and services, and response to previous care; - Ongoing assessment findings shall be recorded in the patient’s clinical record; and - Information obtained from the initial and ongoing assessment is communicated to the interdisciplinary team as appropriate. Review of social worker’s (MSW A) job description summary showed: - Responsible and accountable for assessing the psychological social emotional culture or financial needs that impact patient’s health and recovery; - To provide professional social work services that utilize supportive counseling and clinical knowledge in assessing the needs of patients and families during illness crisis intervention and post discharge panning; - Collaborates with members of health care team in the development of a transition plan and addresses needs in a timely manner; and - Participate in program planning and development to meet the needs of customers within the heal care system and community. Review of CFR 484.55(c)(1) Condition of Participation interpretive guidelines showed in part: - Completion of the comprehensive assessment should provide the home health agency (HHA) with a complete picture of the patient's status to assist the HHA in developing the patient's plan of care; - Assessment of a patient's psychosocial status and his/her functional capacity within the community is intended to be a screening of the patient's relationships, living environment, impact on the delivery of services and ability to participate in his/her own care. RECORD/PATIENT #1: Review of the initial comprehensive assessment dated 10/31/2021 showed: -85 year old admitted to home health agency post stay at hospital for weakness, confusion, fall/generalized weakness. Diagnoses included urinary tract infection and acute encephalopathy (damage to the brain or brain disease); -Patient lived at home with his/her adult child; -Patient required walker to ambulate and assistance with medication planner and administration. The RN initial assessment failed to show the patient had other people living in/and outside the patient's home that are not related to the patient. Clinical record review dated 11/12/2021 at 10:30 AM showed the physical therapy assistant (PTA A) documented he/she contacted MSW A and reported the patient did not have heat but had space heaters. PTA A failed to document he/she reported to the MSW the patient had non-related individuals living in/out of his/her home that he/she wanted off his/her property. Clinical record review dated 11/12/2021 at 3:50 PM showed MSW A documented the following: -He/she received a call from PTA A concerned over the patient’s heat status and discussed possible hotline; -He/she placed a call to the patient’s adult child that lives in the home with the patient; -He/she spoke to the patient’s adult child for 45 minutes; -The patient’s adult child reported unrelated family living in a trailer on the patient’s property and apparently staying inside the patient’s home. Not paying rent or helping with utilities; -The patient’s daughter reported that they were using space heaters for heat but the heater might be fixed on 11/12/2021. *MSW A did not make a home visit to assess the patient’s safety and home environment. Observation during a home visit on 11/16/2021 at 9:30 AM by the surveyor showed the following: -A RV (recreational vehicle) sat to the left of the patient’s house that had a man and a woman in it; -The man entered the patient’s house and cooked in the patient’s kitchen; -The patient and patient’s adult child were in the living room; -The man that was in the RV did not talk to or interact with the patient or the patient’s adult child that lived in the home; -The man left the patient’s home and went to the RV with his food. During an interview on 11/16/2021 at 10:00 AM the patient said: -I would like all the people in the trailer to move; -They do not listen to me; -They walk all over me; -They are lazy and he/she was tired of supporting them. During an interview on 11/16/2021 at 10:00 AM the patient’s adult child that lived in the home said: -The people in the trailer need to move. They were supposed to be helping the patient when he/she was working but they had not been helping the patient for the last one to two months; -The patient and he/she asked the people from the trailer to move but they refuse to leave; -He/she talked to the MSW A once but had not spoken to him/her since nor has he/she ever met with him/her; -The patient’s heat was not fixed because they were waiting on a part; - The man from the trailer threw the dog to ground, they fight all the time and the man slams the doors; -He/she was “totally fearful” of the people from the trailer. During an interview on 11/17/2021 at 11:00 AM RN A said the following: -The patient and patient’s adult child living in the home never verbalized any of this to him/her; -He/she was aware of the patient not having heat last week; -He/she knew MSW A was notified; -He/she would call the MSW A to discuss today’s visit; -He/she never met the patient's other adult child that was the patient’s durable power of attorney. During an interview on 11/17/2021 at 3:10 PM PTA A said the following: -He/she thought the people in the trailer were caregivers of the patient; -Two people live in the trailer and a person in his/her 30’s lives in a room in the house with a one year old child; -He/she reported the patient not having heat and only having a space heater on 11/10/2021 to MSW A because the weather was supposed to be cold and the temperature was supposed to drop in the 20’s; -He/she spoke to MSW A about the people in living in the trailer and heat last week; -He/she did not document his/her communication but should have documented what he/she spoke to MSW A about; -He/she was going to follow up on the heat; -He/she made a visit to see the patient on 11/15/2021 but failed to contact MSW A or document heat not being fixed; -He/she heard that MSW A and RN A hot lined the patient’s living situation and heat; -He/she was not trained to do a safety assessment of the patient’s house and wanted MSW A to make a visit; -MSW A never made home visits; -He/she did not know why MSW A never made home visits to do assessments. During an interview on 11/17/2021 at 3:30 PM MSW A said the following: -The patient’s case manager called him/her and reported the individuals living in the patient's house and the patient having no heat on 11/10/2021; -He/she called and left a message for the patient’s adult child to call him/her back; -He/she did not have a lot of detail about the individuals living in and around the patient’s home but he/she thought the heat was being fixed; -PTA A called him/her on the 11/12/2021 concerned about the people living in and around the patient’s house; -He/she spoke to the patient’s adult child that lived in the house and gave him/her resources; -The patient’s adult child is anxious and requested information for mental health treatment; -The patient’s adult child said he/she was “uncomfortable” with the people living in the trailer but never used the word afraid; -He/she never made a home visit because he/she doesn’t make home visit’s due to his/her own health issues; -He/she was at high risk and did not go into patient homes; -He/she did not know if the patient had heat or not because he/she had not heard back from any staff or the patient’s adult child; -He/she was going to call the patient because it was supposed to be cold; -He/she probably did not document any of his/her attempted calls; -It was not his/her job to remove people off the patient’s property; -He/she called the hotline after RN A reported the observation and visit from 11/16/2021. The above information was discussed with the administrator and case manager on 11/17/2021 at 4:30 PM. During an interview on 11/17/2021 at 4:30 PM the administrator and case manager said; -They were not aware in its entirety the situation at the patient’s home; -MSW A has accommodations and does not make home visits; -He/she expected MSW A to report to him/her if a home assessment needed to be made to arrange for someone to make a visit; -He/she knew MSW A and RN A reported to the hotline regarding the patient’s safety and heat yesterday but he/she should have sent someone to do a full assessment; -A home assessment should have been made immediately in a situation like this.

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 policy review, home visit observation, record review, and interview, the home health agency (HHA) failed to ensure an effective review of all medications the patient is currently using in order to identify ineffective drug therapy, and noncompliance with drug therapy in one (Record/Patient #3) of five full records reviewed. This deficient practice has the potential to affect the medication management of all agency patients. Findings included: Review of the agency policy “Medication Reconciliation” showed in part the following: - Clinicians should notify the physician of any medication discrepancies; and - Clinicians should clarify with the physician any medication orders as needed. Review of the agency policy “10748242 Care Planning (Plan of Care)” states that “The agency uses the CMS-485 as the Plan of Care”. RECORD/PATIENT #3: Review of the CMS-485 plan of care provided by the agency administration, dated 11/12/2021, showed an order for cephalexin (an antibiotic) 500mg one capsule four times daily in "box 10" of the CMS-485 form. The order was incomplete for a stop date. During a home visit observation on 11/16/2021 at 10:30 AM, the skilled nurse informed the patient that the last day to take the antibiotic was 11/17/2021. Observation of the patient’s medication bottle of cephalexin showed nine capsules remained. The patient was also grimacing, moaning during the visit and informed the nurse that his/her pain level was 8 (severe) out of 10. (It should be noted that the nurse failed to look at the patient’s medication bottles during the visit to count remaining antibiotics. Based on the skilled nurse's instructions to the patient, that 11/17/2021 was the last day to take the antibiotic, there would be antibiotic left over and not taken. The skilled nurse also did not assess the patient for the utilization of the PRN pain medication with a pain level of 8). During an interview with the patient on 11/16/21 at 11:30 AM, he/she stated that he/she occasionally uses two tablets of oxycodone every eight hours for pain. (One tablet every 8 hours is ordered). The patient explained that he/she has a tumor pressing on a nerve that causes pain and no medication relieves his/her pain. The patient has surgery scheduled next month to have the tumor removed. During an interview on 11/16/2021 at 1:15 PM the branch clinical manager stated that the case manager is responsible for review of all the patient’s medications.

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 policy review, home visit observation, record review, and interview, the home health agency (HHA) failed to ensure care was provided as written in the individualized plan of care in one (Record/Patient #3) of three home visit observations conducted. This deficient practice has the potential to adversely affect the care provided to all agency patients. Findings included: Review of the agency policy “10748242 Care Planning (Plan of Care)” states that a plan of Care is a written plan developed with the participation of professional staff and the patient, in consultation with and authorized by the physician, according to regulation, which supports the patient's medical, nursing, therapy and social needs in the home setting and serves as the basis for care delivery. RECORD/PATIENT #3: Review of the patient’s clinical record showed the patient was admitted to home health service on 11/12/2021 for wound treatment. Review of the plan of care, dated 11/12/2021 showed an order to perform wound care for mid-line sacrum wound (wound site #2), clean with saline seven days a week, leave open to air (OTA), cover with foam dressing if skin is broken down. During a home visit observation on 11/16/2021 at 11:30 AM, the skilled nurse removed, assessed, and photographed a mid-line sacrum wound. The nurse failed to clean the area with saline as ordered. During an interview on 11/16/2021 at 1:15 PM the branch clinical manager stated that the nurse should have followed the plan of care in regards to wound care.

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 policy review, record review, and interview, the home health agency failed to ensure a written visit schedule was available to the patient in, but not limited to, one (Record/Patient #3) of three home visit observations conducted. This deficient practice has the potential to adversely affect all agency patients. Findings included: Review of the agency policy “10748242 Care Planning (Plan of Care)” states: A plan of Care is a written plan developed with the participation of professional staff and the patient, in consultation with and authorized by the physician, according to regulation, which supports the patient's medical, nursing, therapy and social needs in the home setting and serves as the basis for care delivery. Clinicians are instructed on completion of the Plan of Care during their initial orientation and as indicated thereafter. The Plan of Care shall be developed within five days of the initial assessment for Home Health patients. The plan of care shall be reviewed and revised every 60 days or more frequently as client needs or changes warrant. RECORD/PATIENT #3: During a home visit observation on 11/16/2021 at 11:30 AM, the patient’s home health home folder was reviewed. The calendar tool used by the agency to provide the clinician visit schedule was blank. During an interview on 11/16/2021 at 1:15 PM the branch clinical manager stated that the calendar tool in the patient’s home folder should have been completed by the patient’s case manager nurse on the first visit.

Other pertinent instructions CFR(s): 484.60(e)(4) Any other pertinent instruction related to the patient's care and treatments that the HHA will provide, specific to the patient's care needs. This ELEMENT is not met as evidenced by: Based on policy review, home visit observation, record review, and interview, the home health agency failed to ensure written care instructions were available to the patient in one (Record/Patient #3) of three home visit observations conducted. This deficient practice has the potential to adversely affect all agency patients. Findings included: Review of the agency policy “Care Coordination and Communication” showed that the agency “shall promote effective communication at all levels of the organization regarding patient care activities to achieve safer and effective care.” Review of the agency policy “10748242 Care Planning (Plan of Care)” states: A plan of Care is a written plan developed with the participation of professional staff and the patient, in consultation with and authorized by the physician, according to regulation, which supports the patient's medical, nursing, therapy and social needs in the home setting and serves as the basis for care delivery. Clinicians are instructed on completion of the Plan of Care during their initial orientation and as indicated thereafter. The Plan of Care shall be developed within five days of the initial assessment for Home Health patients. The plan of care shall be reviewed and revised every 60 days or more frequently as client needs or changes warrant. RECORD/PATIENT #3: Review of the patient’s plan of care showed the patient and the patient’s caregiver to provide specific wound care to three separate wound sites. During a home visit observation on 11/16/2021 at 11:30 AM, the patient’s home health home folder was reviewed. The written care instructions form used by the agency to provide the patient specific care instructions was blank. Review of the patient’s plan of care showed the patient and the patient’s caregiver to provide specific wound care to three separate wound sites. During interview with the patient on 11/16/2021 at 11:30 AM, the patient stated that no written instructions on the wound care has been mailed or provided yet. He/she does not have the ability to go to the mailbox regularly due to pain. He/she stated that theft of mail is common in his/her neighborhood. The patient says that his/her caregiver was told how to do the wound treatments on the previous visit of the nurse. During an interview on 11/16/2021 at 1:15 PM the branch clinical manager stated that the written care instructions form in the patient’s home folder should have been completed by the patient’s case manager nurse on the first visit, plan of care updates are then mailed to the patient’s home.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on review of the pre-printed admission booklet, observation, and interview, the home health agency (HHA) failed to ensure the name and contact information of the HHA clinical manager was available to the patient in, but not limited to, one (Record/Patient #3) of three home visit observations conducted. This deficient practice has the potential to adversely affect all patients served by the agency. Findings included: Review of the pre-printed admission booklet showed on the first page, lines/spaces to fill in the names of the clinical manager and clinicians involved in the patient’s care. RECORD/PATIENT #3: Review of the patient’s clinical record showed the patient was admitted to home health service on 11/12/2021 for treatment of a foot wound. During a home visit observation on 11/16/2021 at 11:30 AM, the patient’s home health home folder was reviewed. The first page of the home folder provides lines/spaces to fill in the names of the clinical manager and clinicians involved in the patient’s care. The line for the clinical manager name and contact information was left blank. The name of the clinical manager could not be found on any written information in the patient’s home health folder. During an interview on 11/16/2021 at 1:15 PM the branch clinical manager stated that the name and contact information of the care team in the patient’s home folder should have been completed by the patient’s case manager nurse on the first visit. An email received from the director on 11/17/2021 to the surveyors, stated that all clinicians go through the Start of Care class that reviews the filling out of the patient information booklet (see Start of Care class Agenda Day 2.) This is the document that includes all care team members names and phone numbers including the clinical managers.

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 review of Centers for Medicare & Medicaid Services (CMS) Focused Infection control Guidelines, agency policy, observation, and interview, the agency failed to use standard precautions to prevent the transmission of infections and communicable diseases in one (Record/Patient #1) of three home visit observations and failed to screen visitors/non-employees for COVID-19 (pandemic infection) who entered the home health agency office. This deficient practice has the potential to affect infection control needs for all visitors/non-employees, employees and patients served by the agency. Findings included: Review of the “CMS Focused Infection Control Survey Tool: Acute and Continuing Care,” dated Revised December 2020, showed, in part: - Is signage posted at facility entrances with visitation restrictions and screening procedures; - Does the facility have a screening process for those entering the facility (patients and visitors) to mitigate the risk of COVID-19 (pandemic infection) exposure (for example; exposure to COVID-19 screening questions and assessment of symptoms/illness); and - Are staff trained on appropriate processes (example, questions to ask and actions to take) to rapidly identify and isolate suspect COVID-19 cases? Review of the agency’s policy titled, “Saint Luke’s Health System COVID-19 Plan: Post-Acute Care Facilities and Services, EOC-176,” dated last revised 09/27/2021, showed in part: - Policy: Saint Luke’s Health System and the COVID-19 Safety Coordinator(s) will work collaboratively with non-managerial employees or representatives to assess and address on going COVID-19 hazards. The elements of the COVID-19 plan align with OSHA’s ETS Subpart U in order to promote the safety and wellbeing of employees and patients and residents within the Saint Luke’s Health System; - Saint Luke’s Home Care and Hospice was listed as a facility location; - Saint Luke’s goal is to prevent the transmission of COVID-19 in the workplace. Managers, as well as non-managerial employees and their representatives, are all responsible for supporting, complying with, and providing recommendations to further improve this COVID-19 plan; -In settings where direct patient resident care is provided, Saint Luke’s facilities will screen and triage all clients, patients, residents, delivery people, visitors, and other non-employees entering the setting for symptoms of COVID-19; - As an additional screening measure, symptom screening questions have been embedded in scripting for patient scheduling; and - Screen means asking questions to determine whether a person is COVID-19 positive or has symptoms of COVID-19. Review of the undated educational information “Saint Luke’s Home Care and Hospice Elements of a Home Visit,” showed in part: - Best practice is to call and speak to our patients the NIGHT before our visit (screening); and - We also recommend calling when on our way. RECORD/PATIENT #1: Review of the CMS-485 plan of care provided by the agency administration, dated 11/16/2021, showed the patients start of care was 10/31/2021 with a principal diagnoses included urinary tract infection. Observation on 11/16/2021 showed the following: -RN A entered the patient’s house; -The patient sat in a recliner and the patient’s child stood by his/her parent; -RN A wore a mask but the patient and his/her adult child did not wear a mask; -The patient’s adult child told RN that his/her throat hurt; -RN A took the patients vitals and did an assessment; -RN A screened the patient and patient’s adult child for COVID symptoms after being in direct contact with them for more than ten minutes; and -The patient’s adult child never put a mask on and told the RN A that he/she could not find a mask. RN A failed to offer the patients adult child a mask. During an interview on 11/16/2021 at 10:30AM, RN said the following: -He/she did not screen the patient or caregiver for COVID prior to making the visit; -He/she normally only screened the patient or caregiver prior to visit’s when the patient is first being admitted. The surveyors entered the agency on 11/15/2021 for a recertification survey at 10:55 AM with facemasks in place. The surveyors were greeted and asked to take a seat while a room was being secured for the surveyors to utilize. The surveyors were then escorted to a conference room. Staff failed to screen the surveyors for temperature or ask COVID-19 screening questions upon entrance. The surveyors arrived at the agency again on 11/16/2021 at 8:30 AM and entered the agency without any temperature or screening process completed. During an interview on 11/16/2021 at 11:04 AM, the director stated that anyone that is not a Saint Luke’s Health System employee that enters the agency should be screened.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on accepted standards of practice, record review, home visit observation, and interview, the home health agency (HHA) failed to ensure skilled professional services (nursing service) was delivered according to accepted professional standards in one (Record/Patient #3) of three home visit observations conducted. This deficient practice has the potential to adversely affect all agency patients. Findings included: Review of “Patient Care Practices Wound Care” reference from McGoldrick, M. (2015). Home Care Infection Prevention and Control Program. Saint Simons Island, GA: Home Health Systems, Inc. showed in part “Use aseptic technique to perform wound care, unless otherwise ordered by the physician. The actual wound itself should never be touched with any product that is not sterile. Refer to the “Sterile Technique” and “Aseptic Technique”. RECORD/PATIENT #3: Review of the patient’s clinical record showed the patient was admitted to home health service on 11/12/2021 for treatment of a foot wound. Review of the plan of care, dated 11/12/2021, showed an order to “perform wound care for traumatic left heel wound clean with saline, cover with hydrafera Blue secure with kerlix” twice a week and as needed (PRN). During a home visit observation on 11/16/2021 at 11:30 AM, the following was observed: - The branch nurse remove the soiled dressing from the patient's left heel; - The nurse cleaned the patient's open wound on the left heel with saline solution; - The wound appeared open with slight drainage and a yellow center; - After the nurse had cleaned the patient's wound with saline the patient lowered his/her leg and rested the left heel wound on the floor (which contaminated the wound). The floor was a visibly soiled carpeted surface with debris and hair visible. There was no barrier between the heel wound and the soiled carpeted surface; and - The nurse then reapplied a dressing to the soiled wound without re-cleaning the contaminated wound. During an interview on 11/16/2021 at 1:15 PM the branch clinical manager stated that the nurse should have re-cleaned the wound and applied a clean barrier between the wound and the floor before applying the final dressing.

Org. had partial/extended survey CFR(s): 484.80(f)(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or This ELEMENT is not met as evidenced by: Based on the results of this extended level survey, resulting in noncompliance with one Condition of Participation: 484.55-Comprehensive assessment of patients, the agency may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. The restriction ends 11/18/2023.