Every finding on record at Lutheran Home for the Aged

An extended survey for Medicare recertification for the home health provider was completed on 08/11/2022. The agency had six current patients. Four condition-level deficiencies were identified during this survey. Condition-level deficiencies were identified at: - §484.50 Condition of Participation: Patient Rights; - §484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care; - §484.70 Condition of Participation: Infection Prevention and Control; and - §484.105 Condition of Participation: Organization and Administration of Services. A home health agency that is found out of compliance with any Condition of Participation evaluated as part of a standard 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 G0788. A Covid-19 vaccination survey was completed on 08/11/2022. One deficiency was identified related to the Covid-19 vaccination survey - See Tag G0687. The Emergency Preparedness regulations were reviewed. One standard level deficiency was identified.

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 agency policy, emergency preparedness record review, and interview, the agency failed to test and analyze the testing results of the emergency preparedness plan at least annually. This deficient practice has the potential to affect the effectiveness of the agency's emergency preparedness plan. Findings included: Review of the document titled, "Emergency Disaster Plan (EDP)," last reviewed 01/12/2017, showed that the EDP shall be rehearsed at least annually and any findings/recommendations will be forwarded to the Processes Improvement (PI) committee and the governing authority. Review of the EDP binder showed that the last EDP rehearsal was documented on 03/28/2019. During an interview on 08/10/2022 at 4:00 PM, the chief operating officer stated that they had not been able to perform annual rehearsal (testing) of the EDP since the public health emergency began.

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 agency policy, clinical record review, and interview, the agency failed to assure the accuracy of the Outcome and Assessment Information Set (OASIS) data in, but not limited to, two (Records/Patients #3 and #4) of five full records reviewed. This deficient practice has the potential to affect the OASIS data collection for all of the agency’s patients. Findings included: Review of the agency's policy titled, “Charting,” dated 04/2003, showed the policy failed to contain guidance that the clinician's documentation should be accurate. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to the agency for home health services on 07/18/2022 with a primary diagnosis of fracture of right pubic bone, and secondary diagnoses of chronic kidney disease (a condition in which the kidneys do not function properly for a long period of time), chronic obstructive pulmonary disease (a disease in which the lungs do to process enough oxygen to meet the body's needs). The patient resided in his/her own home with the assistance of family members who do not live with him/her. Review of the referral for home health service was dated 07/15/2022, and the document showed that the date of evaluation was planned for 07/18/2022. Review of the document titled, "Start of Care," dated 07/18/2022, showed that: - MO110 was answered as no specific start of care date ordered by physician; and - Date of referral (MO104) was 07/18/2022. During an interview on 08/10/2022 at 04:00 PM, the chief operating officer stated that the patient’s date of referral should have been 07/15/2022, for OASIS data collection as listed on the referral documentation. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services on 07/18/2022 for assessment and teaching for a primary diagnoses of heart failure (a condition in which the heart is unable to pump enough blood to meet the body's metabolic needs) and chronic kidney disease (a chronic condition in which the kidneys are unable to function properly). The patient also had secondary diagnoses of chronic obstructive pulmonary disease (a condition where the lungs are unable to provide enough oxygen to the body), and diabetes (a disease in which the body is unable to utilize glucose (sugar) to meet its metabolic needs). Review of the referral document dated 07/15/2022 showed that the planned start of care date was 07/18/2022 with no specified start of care date. Review of the document titled, "Start of Care," dated 07/18/2022, showed that: - MO110 was answered as no specific start of care date ordered by physician; and - Date of referral (MO104) was 07/18/2022. During an interview on 08/10/2022 at 04:00 PM, the chief operating officer stated that the patient’s date of referral should have been 07/15/2022, for OASIS data collection as listed on the referral documentation.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on policy review, admission packet review, and interview, the agency failed to provide care and services that met the requirements for the Condition of Participation: Patient Rights. The agency failed to: - Provide written notice of the patient's rights and responsibilities under this rule, and the agency transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities (G0412); - Provide written notice of the patient's rights and responsibilities under this rule and the agency transfer and discharge policies to a patient-selected representative within four business days of the initial evaluation visit (G0422); - Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to: * Completion of all assessments; * The care to be furnished, based on the comprehensive assessment; * Establishing and revising the plan of care; * The disciplines that will furnish care; * The frequency of visits; * Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; * Any factors that could impact treatment effectiveness; and * Any changes in the care to be furnished (G0434); - Receive proper written notice, in advance of a specific service being furnished, if the home health agency (HHA) believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must comply with the requirements of 42 CFR 405.1200 through 405.1204 (G0442); - 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 HHA's (1-800-392-0210, available 7 days a week, 7:00 AM to 8:00 PM) (G0444); - 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: * Agency on Aging; * Center for Independent Living; * Protection and Advocacy Agency; and * Aging and Disability Resource Center.(G0446); and - Be informed on the HHA's policies for transfer and discharge including that the HHA may only transfer or discharge the patient from the HHA if the transfer or discharge is necessary for the patient's welfare because the HHA and the physician who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities (G0454). The cumulative effect of these deficient practices has resulted in the agency's inability to ensure that all patients and/or representatives were informed of their rights and responsibilities. .

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; 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 include: - Written notice of the patient’s rights and responsibilities under this rule, and the agency transfer and discharge policies as set forth in paragraph (d) of this section; - Written notice of the patient’s rights must be understandable to persons who have limited English proficiency; and - Rights and responsibilities must be accessible to individuals with disabilities. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: Review of the agency’s policy titled, “Patient Rights and Responsibility,” revised April 2003, showed the agency recognizes, respects and protects the patient’s right to make decisions concerning his/her health care and the right to be involved in their plan of care within the care of Lutheran Home-Home Health services capacity, its’ mission statement and applicable law. The agency's chief operating officer (COO) provided an admission packet for review on 08/08/2022. The agency's notice of patient rights and other information given to a patient during the initial visit failed to contain: - Information regarding written notice of the patient’s rights and responsibilities and the agency’s transfer and discharge policies; and - Rights and responsibilities must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities. The above findings were reviewed with the COO on 08/10/2022 at 4:00 PM. Per an interview conducted during the review, the COO stated that he/she was unaware the patient rights were not current but now knows they are not. No additional information was provided.

Written notice within 4 business days CFR(s): 484.50(a)(4) Provide written notice of the patient's rights and responsibilities under this rule and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section to a patient-selected representative within 4 business days of the initial evaluation visit. 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 provide the written notice of patient rights that included the patient’s right to have a copy of the patient’s rights and responsibilities and the agency’s transfer and discharge policies provided to a patient-selected representative within four business days of the initial evaluation visit. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all patients served by the agency. Findings included: Review of the admission folder, provided by the chief operating officer (COO) on 08/08/2022, showed the notice of patient rights, and other information given to a patient during the initial visit, failed to contain information regarding the patient’s right to have a copy of the patient’s rights and responsibilities and the agency’s transfer and discharge policies provided to a patient-selected representative within four business days of the initial evaluation visit. The above findings were reviewed with the COO on 08/10/2022 at 4:00 PM. Per an interview conducted during the review, the COO stated that he/she was unaware the patient rights were not current but now knows they are not. No additional information was provided.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. 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 include the patient has the right to participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to completion of all assessments, expected outcomes of care, including patient-identified goals, and anticipated risks and benefits, and any factors that could impact treatment effectiveness. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: Review of the admission folder, provided by the chief operating officer (COO) on 08/08/2022, showed the notice of patient rights, and other information given to a patient during the initial visit, failed to contain information regarding the patient’s right to participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to the following: - Completion of all assessments; - Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; and - Any factors that could impact treatment effectiveness. The above findings were reviewed with the COO on 08/10/2022 at 4:00 PM. Per an interview conducted during the review, the COO stated that he/she was unaware the patient rights were not current but now knows they are not. No additional information was provided.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. 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 include the right to receive proper written notice, in advance of a specific service being furnished if the home health agency (HHA) believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must comply with the requirements of 42 CFR 405.1200 through 405.1204. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all patients served by the agency. Findings included: Review of the admission folder, provided by the chief operating officer (COO) on 08/08/2022, showed the notice of patient rights, and other information given to a patient during the initial visit, failed to contain information regarding the patient’s right to receive proper written notice, in advance of a specific service being furnished if the home health agency (HHA) believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The above findings were reviewed with the COO on 08/10/2022 at 4:00 PM. Per an interview conducted during the review, the COO stated that he/she was unaware the patient rights were not current but now knows they are not. No additional information was provided.

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, home visit observation, and interview, the agency failed to provide patients with the correct hours of operation for the state toll free home health hotline telephone number. This deficient practice has the potential to affect the exercise of patient rights for all agency patients. Findings included: Review of the admission folder, provided by the agency‘s chief operating officer (COO) on 08/08/2022, showed the patient rights information, and other information provided to patients on admission, contained the state toll free home health telephone hotline hours of operation as 7:00 AM to Midnight, seven days a week (the correct hours of operation are 7:00 AM to 8:00 PM, seven days a week.) RECORD/PATIENT #1: During a home visit on 08/08/2022 at 11:42 AM, review of the agency-provided home health admission packet showed the state home health hotline hours as 7:00 AM to Midnight. RECORD/PATIENT #2: During a home visit on 08/09/2022 at 11:00 AM, review of the agency-provided home health admission packet showed the state home health hotline hours as 7:00 AM to Midnight. The above findings were reviewed with the COO on 08/10/2022 at 4:00 PM. Per an interview conducted during the review, the COO stated that he/she was unaware the patient rights were not current but now knows they are not. No additional information was provided.

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 ensure the patient was advised of the name, address, and telephone number of the Federally-funded and state-funded entities that serve the area where the patient resides. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s current patient roster showed the agency was serving patients in Bollinger, Scott, and Cape Girardeau counties (the agency also serves Perry and Stoddard counties); Review of the agency’s admission packet included an undated notice titled, “List of Federal and State Agency Resources,” that showed; - The agency provided the telephone numbers and addresses for agencies on aging in Jefferson City, MO and Washington D.C. and failed to provide contact information for the agency on aging (Aging Matters) located in Cape Girardeau, MO; - The agency provided the telephone number and address for the Independent Living Resource Center in Jefferson City, MO and failed to provide contact information for the Southeast Missouri (SEMO) Alliance for Independent Living, Inc. (serves Bollinger, Cape Girardeau, and Scott counties); and - The agency provided the telephone number and address of aging/disability services in Jefferson City, MO and Washington D.C. and failed to provide the contact information for the SEMO Alliance for Disability Independence (SADI) which serves the Cape Girardeau area. The above findings were reviewed with the chief operating officer (COO) on 08/10/2022 at 4:00 PM. Per an interview conducted during the review, the COO stated that he/she was unaware the patient rights were not current but now knows they are not. No additional information was provided.

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on policy review, review of the agency’s current patient rights information, and interview, the agency failed to provide the written notice of patient rights to include that the patient and representative (if any) have a right to be informed that the agency may only transfer or discharge the patient from the agency if the transfer or discharge is necessary for the patient’s welfare because the agency and the physician who is responsible for the home health plan of care agree that the agency can no longer meet the patient’s needs, based on the patient’s acuity. The agency must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the agency’s capabilities. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Review of the agency’s policy titled, “Discharge Policy,” dated/revised 10/2019, showed, in part: - Patient will be discharged when one or more of the following occurs: * The transfer or discharge is necessary for the welfare of the patient; * The patient or payer will no longer pay for the care; * The physician and agency agree that the patient has achieved the measurable outcomes/goals stated in the plan of care; * The patient refuses services; * The agency determines that the patient must be discharged for cause; and - The policy failed to include that the agency and physician responsible for the home health plan of care agree that the agency can no longer meet the patient’s needs, based on the patient’s acuity. - The policy also failed to include the agency must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the agency’s capabilities. The chief operating officer (COO) provided an admission packet for review on 08/08/2022. The agency’s notice of patient rights and other information given to a patient during the initial visit contained no written information regarding the patient and representative (if any) have a right to be informed of the agency’s policies for transfer and discharge when the agency can no longer meet the patient’s needs. The above findings were reviewed with the COO on 08/10/2022 at 4:00 PM. Per an interview conducted during the review, the COO stated that he/she was unaware the patient rights were not current but now knows they are not. No additional information was provided.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interview, the agency failed to complete the initial assessment of the patient within 48 hours of the referral to home care, or 48 hours after the patient’s return home, or on the physician ordered start of care date in, but not limited to, two (Records/Patient’s #2 and #4) of five full records reviewed. This deficient practice has the potential to affect the immediate care needs of all the agency’s patients. Findings included: Review of the agency’s policy titled, “Patient Nursing Assessment,” dated/revised 11/2017, showed home health care registered nurses (RNs) will attempt to contact every patient within 48 hours of his/her admission to the agency in order to arrange an appointment for the patient’s initial nursing assessment. RECORD/PATIENT #2: Review of the document titled, “Order and Certification for Home Care Services,” showed: - The physician signed the order on 07/27/2022; and - There was no physician ordered specified start of care date. Review of the referral for home health service showed; - The date of referral was 07/29/2022 (Friday); - The area designated for a physician specified start of care date was marked with a null symbol (used to indicate empty or zero); and - The date of evaluation/start of care was planned for 08/01/2022 (Monday). Review of the physician’s order, dated 08/01/2022, showed the following: - Patient was discharged from skilled nursing facility (SNF) on 07/29/2022. He/she had a delayed start of care on 08/01/2022 per his/her choice; - Order was written by the registered nurse (RN) and sent to the physician on 08/01/2022 (3 days after the physician referral date); and - The order was signed by the physician on 08/02/2022. Review of clinical record failed to show: - A physician ordered start of care date for 08/01/2022; and - Communication that occurred between the agency and the physician within the 48 hours after the referral stating that the patient is choosing to delay admission until Monday 08/01/2022. RECORD/PATIENT #3: Review of the referral for home health service showed: - The date of referral was 07/15/2022 (Friday); - The area designated for a physician specified start of care date was marked with a null symbol (used to indicate empty or zero); and - The date of evaluation/start of care was planned for 07/18/2022 (Monday). Review of the physician’s order, dated 07/18/2022, showed the following: - Patient was discharged from SNF on 07/15/2022. He/she had a delayed start of care on 07/18/2022 per his/her choice; - Order was written by the RN and sent to the physician on 07/18/2022 (3 days after the physician referral date); and - The order was signed by the physician on 07/19/2022. Review of clinical record failed to show: - A physician ordered start of care date for 07/18/2022; and - Communication that occurred between the agency and the physician within the 48 hours after the referral stating that the patient is choosing to delay admission until Monday 07/18/2022. RECORD/PATIENT #4: Review of the document titled, “Order and Certification for Home Care Services,” showed: - The physician signed the order on 07/12/2022; and - There was no physician ordered specified start of care date. Review of the referral for home health service showed; - The date of referral was 07/15/2022 (Friday); - The area designated for a physician specified start of care date was marked with a null symbol (used to indicate empty or zero); and - The date of evaluation/start of care was planned for 07/18/2022 (Monday). Review of the physician’s order, dated 07/182022, showed the following: - Patient discharged from SNF on 07/15/2022. He/she had a delayed start of care on 07/18/2022 per his/her choice; - Order was written by the RN and sent to the physician on 07/18/2022 (3 days after the physician referral date); and - The order was signed by the physician on 07/25/2022. Review of clinical record failed to show: - A physician ordered start of care date for 07/18/2022; and - Communication that occurred between the agency and the physician within the 48 hours after the referral stating that the patient is choosing to delay admission until Monday 07/18/2022. Findings were reviewed with the chief operating officer (COO) and the director of rehabilitation services on 08/10/2022 at 4:00 PM. The COO stated that he/she was not aware that an order obtained more than 48 hours after the referral was not in compliance with regulatory requirements. The director of rehabilitation services stated that he/she did not know that the referral had to be completed within 48 hours despite the patient request order. No further documentation was provided.

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 policy review, clinical record review, and interview, the agency failed to ensure the skilled clinician’s assessments of patients accurately reflected the patient’s current health status for one (Record/Patient #4) of five full records reviewed. This deficient practice has the potential to affect the identification of patient needs for all patients served by the agency. Findings included: Review of the agency’s policy titled, “Patient Nursing Assessment,” dated/revised 11/2017, showed the following purpose: - To assess the patient’s physical, psychological, social and spiritual status; and - To collect baseline data about the patient’s condition. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services on 07/18/2022 for assessment and teaching for a primary diagnoses of heart failure (a condition in which the heart is unable to pump enough blood to meet the body's metabolic needs) and chronic kidney disease (a chronic condition in which the kidneys are unable to function properly). The patient also had secondary diagnosis of chronic obstructive pulmonary disease (a condition where the lungs are unable to provide enough oxygen to the body), and diabetes (a disease in which the body is unable to utilize glucose (sugar) to meet its metabolic needs). Review of the document titled, "Order Summary Report," dated 07/13/2022 from the discharging facility showed the following: - Combo cream to groin, buttocks, under abdominal folds, and under gluteal folds every shift; and - Skin Prep to heels every shift. Review of document titled, "OASIS-D1 Start of Care," dated 07/18/2022 showed that the visit failed to contain documentation of the assessment of patient’s groin, buttocks, abdominal folds, gluteal folds, and heels. During an interview on 08/10/2022 at 04:00 PM, the chief operating officer stated that they would expect to see documentation of the assessment of the patient’s pain, buttocks, abdominal folds, gluteal folds, and heels that were identified on the facility order summary.

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, record review, home visit observation, and interview, the agency failed to ensure the registered nurse performed an accurate review/update of all medications the patient was currently using in, but not limited to, three (Records/Patients #1, #2, and #3) of five full records reviewed. This deficient practice has the potential to affect the agency’s ability to ensure safe and effective use of medications for all patients served by the agency. Findings included: Review of the agency’s undated policy titled, “Review of Patient’s Drug Regimen,” showed; - Drug regimen review to be completed by the nurse upon admission and on resumption of care; and - Physician or the physician designee will be contacted within one calendar day to resolve clinically significant medication issues to include major drug interactions or duplication of drug therapies. Review of the agency’s policy titled, “Charting,” dated/revised April 2003, showed: - Agency staff and interdisciplinary team members document the home health care given the patient during each home health care visit on the same day service is rendered; and - Such documentation includes patient’s full name, orders for drugs, diet, treatment and activity. RECORD/PATIENT #1: Observation and interview on 08/08/2022 beginning at 11:42 AM, during the patient’s home visit, showed the following medication discrepancies with the agency’s medication profile: - The medication profile showed an order for diltiazem (used to treat high blood pressure and chest pain) 360 milligrams (mg) by mouth (PO) daily. The patient did not have diltiazem in the home and stated that it was discontinued; - The medication profile showed an order for digoxin (use to treat heart failure and heart rhythm problems) 0.25 mg PO daily. The patient did not have digoxin in the home and stated that it was discontinued; and - The patient had a bottle of lorazepam (a narcotic used to treat anxiety) 1mg PO daily as needed (PRN). This medication was not included on the medication profile. RECORD/PATIENT #2: Observation and interview on 08/09/2022 beginning at 10:00 AM, during the patient’s home visit, showed the following medication discrepancies with the agency’s medication profile: - The medication profile showed the patient was taking Apixaban (blood thinner) 15 mg PO twice daily. The medication bottle in the home showed the dosage was changed to 20 mg PO once daily on 08/04/2022. The patient stated that the doctor changed the dose when he/she went about his/her right foot discoloration and the nurse made a home visit yesterday (08/08/2022). This dosage change was not updated on the patient’s medication profile; - The patient had a bottle of cephalexin (an antibiotic) 500 mg take one capsule PO every 12 hours for seven days. The prescription label was dated 08/04/2022 and the patient stated that the doctor gave him/her the medication for his/her right leg/foot and the nurse made a home visit yesterday (08/08/2022). This medication was not included on the medication profile; - The patient had a bottle of promethazine (used to treat nausea/vomiting) 25 mg PO every six hours PRN. This medication was not included on the medication profile; - The patient had a bottle of Advil PM (for mild pain and promotes sleep) liquid gels 200 mg (ibuprofen) and 25 mg (diphenhydramine) take two gel capsules PO at bedtime PRN. This medication was not included on the medication profile; - The patient had a bottle of extra strength acetaminophen 500 mg take two PO every six hours PRN. This medication was not included on the medication profile; and - The patient had a bottle of loperamide hydrochloride (used to treat diarrhea) 2 mg take two PO after the first loose stool and one after each subsequent loose stool, not to exceed more than four tablets in a 24 hour time period PRN. This medication was not included on the medication profile. RECORD/PATIENT #3: Review of the document titled, “PTA [physical therapy assistant] Visit,” dated 07/21/2022, showed that the patient was using Tylenol (a non-opioid medication used to treat pain) twice a day for pain management. Review of the document titled, "Home Health Certification and Plan of Care," dated 07/18/2022, showed that the document failed to contain orders for the use of Tylenol for pain control. During an interview on 08/10/2022 at 4:00 PM, the chief operating officer and the director of rehabilitation stated that they would expect the nurse to review and update the patient’s medications with each nursing visit and any changes to be entered into the patient’s medication profile.

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 policy review, clinical record review, and interview, the agency failed to provide care and services that met the requirements for the Condition of Participation: Care Planning, Coordination of Services and Quality of Care. The agency failed to: - Include all the elements of an individualized plan of care (G0574); and - Promptly alert the physician to any changes in the patient’s conditions or needs that suggest outcomes are not being achieved, and/or that the plan of care should be altered (G0590). The cumulative effect of these deficient practices has the potential to affect individualized and physician ordered care provided to all the agency’s 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 agency failed to include all the elements of an individualized plan of care in, but not limited to, four (Records/Patients #1, #2, #3, and #4) of five full records reviewed. This deficient practice has the potential to affect all of the patients served by the agency. Findings included: Review of the agency’s undated policy titled, “Client Plan of Care,” showed: - The purpose is to ensure the provision of quality and legally approved home health care services; - The plan of care (POC) includes, in part, the following: * Patient’s diagnoses; * The type of nursing services and equipment required; * Rehabilitation and therapy services; * Functional limitations; * Medication and treatment; *Any safety measures to protect the patient from injury; and * Any other appropriate items Review of the agency’s policy titled, “Patient Nursing Assessment,” dated/revised 11/2017, showed, in part: - The purpose is to assess the patient’s physical, psychological, social and spiritual status and collect baseline data about the patient’s condition; - The home health registered nurse (RN) performs and documents the initial nursing assessment; and - The RN begins the patient’s plan of care based on the initial assessment. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services with a primary diagnosis of clinical aftercare of a cardiac pacemaker (an implanted device that helps control the heartbeat) and additional diagnoses of congestive heart failure (a chronic condition in which the heart does not pump blood as well as it should), hypertension (high blood pressure), obstructive sleep apnea (a sleep-related disorder that causes the patient to repeatedly stop and start breathing while they sleep), and a chronic wound on the right lower extremity (leg). The patient lives in his/her own home with his/her spouse. Review of the start of care assessment, dated 07/22/2022, showed, in part, the following; - The patient had chronic edema (swelling) to bilateral lower extremities (BLE) (right and left legs/feet); and - The patient’s peripheral pulses (the pulses that are palpable at the legs and feet) are difficult to palpate. Review of skilled nurse (SN) notes, with dates ranging from 07/21/2022 through 08/05/2022, showed, in part, the following: - The SN noted edema to BLE and that the peripheral pulses were difficult to locate at each visit; and - On 07/29/2022 and 08/05/2022, the SN documented that the patient does not weigh due to fear of falling. Review of the agency’s documents titled, “Home Health Interdisciplinary Meeting,” dated 07/27/2022 and 08/03/2022, showed the patient was non-compliant with obtaining weights. Review of the plan of care (POC), dated 07/22/2022 through 09/19/2022, showed: - A physician order for furosemide and hydrochlorothiazide (both used to reduce swelling); - A physician’s order for fluid restriction of 2 liters every 24 hours and a low sodium diet; - An order to notify the physician of a patient weight gain or loss of two pounds; and - The POC failed to include the patient’s chronic edema, nursing interventions to treat edema, patient education regarding the edema, and that the patient is non-compliant with being weighed. During an interview on 08/10/2022 at 4:00 PM, the chief operating officer stated that he/she would expect the patient’s edema and individualized interventions and education to be included on the patient’s POC. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to the agency from their skilled nursing facility (SNF) on 08/01/2022 with a primary diagnosis of pulmonary embolism (a blood clot that has lodged in the lungs, usually caused by blood clots that travel from other parts of the body) and secondary diagnoses of acute embolism and thrombosis of right tibial vein (DVT- deep vein thrombosis, a blood clot in the lower leg), and type 2 diabetes (a condition that affects the way the body processes blood sugar to meet its metabolic needs). The patient lives in his/her own home with the assistance of family members who do not live with him/her. Review of the start of care assessment, dated 08/01/2022, showed: - The patient is forgetful in new or complex situations; - Edema (swelling) was noted to bilateral lower extremities (BLE) (right and left legs/feet); - A pain assessment showed the following; * Pain intensity was a “10” on a scale of 0 (no pain) to 10 (worst pain imaginable); * Duration was constant; * Quality was sharp; * Nothing made the pain better; * Pain frequency was all of the time; * Patient took tramadol (used for moderate to severe pain) for pain with little relief; and * Patient’s pain goal was a “0” on the 0 to 10 pain scale. Review of skilled nurse (SN) notes, dated 08/04/2022, showed, in part, the following; - The patient was forgetful; - Edema to BLE; and - Rated pain is a 10/10 (on a 0 to 10 pain scale) all the time and nothing provided relief. Review of the physical therapy evaluation, dated 08/01/2022, showed: - Edema to BLE; - Patient rated constant pain as a 10/10 in right knee and nothing relieved the pain; and - The physical therapist (PT) noted no significant limitations and the patient displayed inconsistent signs/symptoms for a 10/10 rated pain. Review of the physical therapy assistant (PTA) notes, with dates ranging from 08/05/2022 to 08/08/2022 showed, in part, the patient: - Rated pain as a 7/10 to a 10/10; - Denied any relief with pain meds or rest; and - Participated in therapy and displayed inconsistent signs/symptoms for a 10/10 rated pain. Review of the occupational therapist (OT) evaluation showed the patient: - Reported that pain was biggest limiting factor; - Rated pain as a 10/10; - Reported no relief from medication or ice; and - Participated in therapy and despite severe pain rating, did not demonstrate physical limitations or distress. Review of the plan of care (POC), dated 08/01/2022 through 9/29/2022, showed the POC failed to include: - Interventions to assess the right lower extremity (RLE) for signs of worsening DVT (redness, warmth, increased pain); - Education on measures to reduce edema; - Limitations related to patient’s forgetfulness; - Patient has limited understanding of the 0 to 10 pain scale; - Patient has historically exaggerated her pain when using a 0 to 10 pain scale; and - Individualized interventions to assist with retention of patient teaching. During an interview on 08/10/2022 at 3:10 PM, the registered nurse stated that the patient always rated his/her pain at a 10/10. He/she will be perfectly pleasant and laughing/joking around and then say his/her pain is a 10/10. The patient was a resident at their long term care (LTC) facility prior to admitting to home health and consistently rated his/her pain at a 10/10. The above findings were reviewed with the chief operating officer (COO), chief financial officer (CFO), and the director of rehabilitation (rehab) on 08/10/2022 at 4:00 PM. During the interview, the COO, CFO, and rehab director all stated that this patient was well known to them from the LTC side of the facility and has consistently rated his/her pain as a 10/10. The director of rehab stated that, in LTC, the patient would rate his/her pain at a 10/10 until the therapist explained, in depth, what the 10 of 10 rating was on the 0 to 10 pain scale. The patient would then, verbalize an understanding and rate their pain appropriately. Due to the patient’s forgetfulness, this conversation had to take place each time pain was assessed. The CFO, COO, and rehab director all stated the POC should have been individualized to reflect the patient’s teaching requirements. They would also expect the POC to include interventions to assess for DVT, elevation of lower extremities to decrease swelling, methods needed to assure the patient has an understanding of the pain scale and that the patient had historically exaggerated his/her pain rating when using the numeric 0 to 10 pain scale. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to the agency for home health services on 07/18/2022 with a primary diagnosis of fracture of right pubic bone, and secondary diagnoses of chronic kidney disease (a condition in which the kidneys do not function properly for a long period of time), chronic obstructive pulmonary disease (a disease in which the lungs do not process enough oxygen to meet the body's needs). The patient resided in his/her own home with the assistance of family members who do not live with him/her. Review of the document titled, “Lutheran Home-Home Health Initial Plan of Care,” dated 07/18/2022, showed that the patient had orders to use hot packs or cold packs. The order failed to contain patient specific details including location and frequency of use. During an interview on 08/10/2022 at 04:00 PM, the director of rehabilitation stated that they would expect orders for cold packs to contain directions for use including location of application. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services on 07/18/2022 for assessment and teaching for a primary diagnoses of heart failure (a condition in which the heart is unable to pump enough blood to meet the body's metabolic needs) and chronic kidney disease (a chronic condition in which the kidneys are unable to function properly). The patient also had secondary diagnoses of chronic obstructive pulmonary disease (a condition where the lungs are unable to provide enough oxygen to the body), and diabetes (a disease in which the body is unable to utilize glucose (sugar) to meet its metabolic needs). Review of the document titled, "Order Summary Report," dated 07/13/2022, from the discharging facility showed the following facility orders: - Diet: 2gram sodium, regular texture, 2 liter fluid restriction; - Antifungal powder under left and right armpit every shift; - Check weight daily and report gain of 2-3 pounds in a day or 5 pounds in a week to the physician; and - Oxygen at 2 liters per minutes continuously. Review of document titled, "OASIS [Outcome and Assessment Information Set)-D1 Start of Care," assessment, dated 07/18/2022, showed: - The patient had redness noted under bilateral breast and axillary regions. Daughter was instructed on use of antifungal power and moisture prevention, - Lungs were clear with oxygen at 2 LPM [liters per minute] -Endocrine assessment showed the patient did not check blood glucose (BG) or use insulin or take oral hyperglycemic medication; and - Diet Orders: Renal diet Review of the document titled, "Home Health Certification and Plan of Care," dated 07/18/2022, showed that the document failed to contain: - Orders for the assessment of diabetes or a statement that the clinicians would not monitor diabetes; - Contain orders for the use of oxygen; - Diet order for renal diet; - Orders for the nursing management of diabetes; - Orders for daily weights associated with heart failure management; and - Orders for antifungal powder. During an interview on 08/10/2022 at 04:00 PM, the director of rehabilitation and chief operating officer stated that they would expect orders for the antifungal cream, management of diabetes, oxygen, and daily weights to be on the plan of care for this patient, and a diet order that reflected the patient’s fluid restriction.

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 policy review, clinical record review, and interview, the agency failed to promptly alert the physician to any changes in the patient’s condition or needs that suggest outcomes are not being achieved and/or that the plan of care should be altered in two (Records/Patients #1 and #2) of five full records reviewed. This deficient practice has the potential to affect the provision of care to all patients served by the agency. Findings included: Review of the agency’s policy titled, “Patient Nursing Assessment,” dated/revised 11/2017, showed, in part: - The purpose is to assess the patient’s physical, psychological, social and spiritual status and collect baseline data about the patient’s condition; - The registered nurse (RN) assesses congestive heart failure (CHF, a chronic condition in which the heart does not pump blood as well as it should); signs/symptoms/monitoring, as appropriate; - The RN assesses diabetes signs/symptoms/monitoring, as appropriate; - RN does subsequent home health care nursing assessments, as appropriate; and - RN consults with the patient’s attending physician, as appropriate. Review of the agency’s undated policy titled, “Pain Assessment and Management,” showed, in part: - Conduct a comprehensive pain assessment upon admission or if there is onset of new pain or worsening of existing pain; - Communicate with the provider regarding the patient’s pain, steps taken to control pain, and the effectiveness; - Report significant changes in the level of the patient’s pain to the physician; and - Report prolonged, unrelieved pain despite interventions to the physician. RECORD/PATIENT #1: Review of the start of care assessment, dated 07/22/2022, showed the patient had chronic edema (swelling) to bilateral lower extremities (BLE) (right and left legs/feet). Review of the plan of care (POC), dated 07/22/2022 through 09/19/2022, showed, in part: - A diagnosis of CHF; - An order for furosemide (a diuretic, used to treat swelling) 20 milligrams (mg) two tablets daily; - An order for hydrochlorothiazide (a diuretic, used to treat swelling) 25mg once daily; - An order for carvedilol (used for high blood pressure and heart failure) 6.25mg twice daily; - An order for cephalexin (an antibiotic) 500 mg three times daily for ten days; and - Orders to report a weight gain or loss of two pounds to the physician. Review of the skilled nurse (SN) note, dated 07/25/2022, showed: - Patient reports getting Lasix (furosemide) 80mg intravenously (IV) at his/her physician’s appointment; - Patient reports that he/she feels he/she was given too much diuretic and therefore did not take his/her furosemide, hydrochlorothiazide, carvedilol, and cephalexin. The patient had placed calls to the physician’s office to let them know (does not say whether physician was actually notified by the patient); and - The SN failed to notify the physician that the patient did not take his/her medications as ordered. Review of the SN note, dated 07/27/2022, showed: - Patient does not check daily weights stating he/she cannot stand on the scale for fear of falling; and - The SN failed to notify the physician that the patient was non-compliant with obtaining weights. Review of the SN note, dated 07/29/2022, showed: - Patient reports pain to left shoulder with use (a new complaint); - Patient does not get daily weights due to he/she cannot stand on scale for fear of falling; - The SN failed to notify the physician of the new complaint of pain in the left shoulder; and - The SN failed to notify the physician that the patient was non-compliant with weights. Findings were reviewed the chief operating officer (COO) on 08/10/2022 at 4:00 PM. Per the interview, the COO stated he/she would expect the clinician to notify the physician of the patient’s non-compliance with weights and medication and any new onset of pain. RECORD/PATIENT#2: Review of the clinical record showed the patient was admitted to the agency from their skilled nursing facility (SNF) on 08/01/2022 with a primary diagnosis of pulmonary embolism (a blood clot that has lodged in the lungs, usually caused by blood clots that travel from other parts of the body) and secondary diagnoses of acute embolism and thrombosis of right tibial vein (DVT- deep vein thrombosis, a blood clot in the lower leg), eschar (a black leathery scab) covered ulcerations to right heal, right great toe, and left great toe, and type 2 diabetes (a condition that affects the way the body processes blood sugar to meet its metabolic needs). The patient lives in his/her own home with the assistance of family members who do not live with him/her. Review of the start of care assessment, dated 08/01/2022, showed: - A note stating that the patient does not have orders to check blood glucose at home; - Edema (swelling) to bilateral lower extremities (BLE) (right and left legs/feet); - A pain assessment showed the following; * Pain intensity was a “10” on a scale of 0 (no pain) to 10 (worst pain imaginable); * Duration was constant; * Nothing made the pain better; * Pain frequency was all of the time; * Patient took tramadol (used for moderate to severe pain) for pain with little relief; and - The SN failed to notify the physician that the patient did not have order for blood sugar checks but took insulin medications to lower his/her blood sugar; and - The SN failed to notify the physician of the edema and the patient’s complaint of pain. Review of the POC, dated 08/01/2022 through 09/29/2022 showed: - An order for Tresiba (an injectable insulin used to lower blood sugar) 37 units injected subcutaneously (into the fat tissue) every day; - An order for glipizide (an oral medication used to decrease blood sugar) 5 mg twice daily; Review of the SN note, dated 08/04/2022, showed; - The patient does not have orders to check blood glucose at home; and - The patient states that pain is a 10/10 on a 0 (no pain) to 10 (worst pain imaginable) pain scale; and - The SN failed to notify the physician regarding the missing order for blood glucose checks and of the patient’s pain. Review of the physical therapy notes, with dates ranging from 08/01/2022 to 08/08/2022, showed the patient rated his/her pain at a 10/10 at every visit. Review of the occupational therapy (OT) note, dated 08/03/2022, showed, in part: - The patient reported continued pain in the right knee and foot; - The OT observed a new area of redness on the top of the right foot; and - The OT conferenced call the registered nurse with findings. Review of the clinical record failed to show the physician was notified regarding: - The patient taking oral and injectable medications to lower blood sugar without orders to check blood glucose levels; - The patient had edema in BLE’s; - The patient continuously complained of pain and rated the pain at a 10/10; and - The patient developed a new area of redness on the top of the right foot. During an interview on 08/10/2022 at 1:30 PM, the medical assistant at the primary physician’s office stated that he/she could find no documentation, nor could he/she recall, that the agency notified them regarding pain or other patient concerns. The only communication received from the agency was a fax of the POC. During an interview on 08/10/2022 at 3:10 PM, Employee A stated that the patient has always rated their pain as a 10/10 and nothing ever helps relieve it. He/she stated that the OT took a picture of the patient’s reddened area on the right foot and sent it to him/her using the agency’s secure messaging. Based on the foot’s appearance in the photo, he/she contacted the patient’s power of attorney (POA) and suggested that the POA move the patient’s primary physician appointment to an earlier date. Employee A stated that he/she did not call the physician’s office himself/herself to report the new area on the right foot, the pain, or the edema. Stated that there is always edema present. During an interview on 08/10/2022 at 4:00 PM, the chief operating officer (COO), chief financial officer (CFO), and the director of rehabilitation all stated that the patient is well known to them and has a history of exaggerating her pain when using the numeric pain scale but they agreed that the nurse should have called the physician to notify them that the patient did not have orders to check blood sugars but was taking insulin and oral medication to lower blood sugar. They also agreed that the nurse should have notified the physician of the edema, the new area of concern on the right foot. The COO, CFO, and rehabilitation director stated that, even though the patient had a history of exaggerating his/her pain, the physician should have been contacted. The physician was notified when the patient was in long term care but had not been notified since the patient was admitted to home health.

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 agency policy, review of agency quality assurance and performance improvement (QAPI) records, and interview, the agency failed to ensure that infection control and adverse patient events were measured, analyzed, and tracked, to assess processes of care, services and operations. This deficient practice has the potential to affect the processes of care, services, and operations for all of the agency’s patients. Findings included: Review of the agency's policy titled, “Quality Assurance Improvement Plan,” dated 11/30/2017, showed, in part: - The QAPI information gathered is analyzed and compared to benchmarks and/or targets established by the agency; - Weekly interdisciplinary team (IDT) notes are reviewed including adverse events/complaints on a weekly basis; and - There is a mechanism for communicating patterns, trends identified during IDT meetings to broader QAPI committee. Review of the agency's QAPI program notes showed that the last summary of the agency’s QAPI program was performed in 2019. Review of the document titled, “Performance Improvement Proposal [PIP],” was last reviewed and/or updated on 08/01/2021. During an interview on 08/09/2021 at 03:45 PM, the chief operating officer stated that there were no additional QAPI data or updated PIPs available.

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 agency policy, review of the agency’s quality assurance and performance improvement (QAPI) records, and interview, the agency failed to assure that performance improvement activities track adverse patient events, analyze their causes, and implement preventive actions. This deficient practice has the potential to affect the agency’s ability to implement preventative actions to reduce adverse patient events. Findings included: Review of the agency's policy titled, “Quality Assurance Improvement Plan,” dated 11/30/2017 showed: - The QAPI information gathered is analyzed and compared to benchmarks and/or targets established by the agency; - Weekly interdisciplinary team (IDT) notes are reviewed including adverse events/complaints on a weekly basis; and - There is a mechanism for communicating patterns, trends identified during IDT meetings to a broader QAPI committee. Review of the agency QAPI program showed that the last documentation of activities to track adverse patients, analyze their causes, and implement preventive actions was in 2019. During an interview on 08/09/2021 at 03:45 PM, the chief operating officer stated that there were no additional QAPI data or updated performance improvement proposals (PIPs) available.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on review of agency policy, governing body minutes, and interview, the agency failed to ensure the governing body evaluated the quality assurance and performance improvement (QAPI) activities. This deficient practice has the potential to affect the effectiveness of the agency’s QAPI activities. Findings included: Review of the agency's policy titled, “Quality Assurance Improvement Plan,” dated 11/30/2017, showed that a summary of QAPI activities and outcomes will be reviewed and approved by the QAPI committee and the Board regularly with quarterly updates emailed to organizational leadership, staff and key stakeholders. Review of the agency's QAPI program showed that the last summary of the agency QAPI program was performed in 2019. Review of the document titled, “Performance Improvement Proposal [PIP],” was last reviewed and/or updated on 08/01/2021. Review of the agency’s governing body minutes, with dates ranging from January 26, 2022 to July 27, 2022, failed to show that the governing body is monitoring and approving QAPI activities. During an interview on 08/09/2021 at 03:45 PM, the chief operating officer stated that there were no additional QAPI data or updated performance improvement proposals (PIPs) available.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on policy review, clinical record review, and interview, the agency failed to provide care and services that met the requirements for the Condition of Participation: Infection Prevention and Control. The agency failed to: - Follow accepted standards of practice to prevent the transmission of infections and communicable diseases (G0682); - Maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases (G0684); and - Develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19 (G0687). The cumulative effect of these deficient practices has the potential to affect the health and safety of all patients served by the agency. .

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 agency failed to follow accepted standards of practice to prevent the transmission of infections and communicable diseases in, but not limited to, one (Record/Patient #1) of three home visit observations conducted. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: Review of the agency’s policy titled, “Infection Control – Bag Technique,” revised April 2003, showed, in part: - Purpose is to prevent contamination of the nursing bag and to prevent cross-contamination between patient and staff; - Observe principles of universal precautions at all times; - Once in the patient’s home, select the cleanest or most convenient work area and spread a bag barrier; and - Place the bag on the bag barrier. RECORD/PATIENT #1: Observations during a home visit on 08/08/2022 beginning at 11:42 AM, showed: - The registered nurse (RN) entered the patient’s home and laid his/her nursing bag on the kitchen chair without placing a barrier; - RN removed vital signs supplies and clean gloves and placed them on a folder that was on the kitchen table, no barrier was placed between the folder and the supplies; - RN removed the patient’s new dressing from the package and laid it directly on the kitchen table without using a barrier between the dressing and the table; and - RN applied the medicated gel to the open dressing while it laid on the table then applied the dressing to the patient’s leg wound. Per an interview conducted immediately following the home visit, the RN stated that he/she will use a barrier under the nursing bag if he/she has to place the bag on the floor but does not always use one if he/she is just placing the bag in a chair. Stated that he/she did not think about placing the dressing and supplies directly on the table. He/she will use a barrier if the house is dirty. Findings were reviewed with the chief operating officer (COO) and chief financial officer (CFO) on 08/10/2022 at 4:00 PM. They stated that they would expect the clinician to have used a barrier before placing their nursing bag in the chair. They also stated that the clinician should have used a barrier under the vital signs equipment and under the patient’s dressing.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on review of agency policy, the agency’s infection control documentation, and interview, the agency failed to assure that a coordinated agency-wide program for the surveillance, identification, prevention, control, investigation of infectious diseases was an integral part of the agency quality assurance and performance improvement (QAPI) program. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: Review of the undated document titled, “Purpose,” found in the policy section of the Infection Control Manual showed that the infection control program monitors and investigates the causes and manner of spread of infection within the facility. Review of the undated documents titled, “Open Infection Control Cases,” and, “Closed Infection Control Cases,” showed a listing of patient infections for 10/19/2021 to 8/3/2022. During an interview on 08/10/2022 at 04:00 PM, the chief operating officer stated that there was no documentation of the investigation or summation of agency infections for trends since the last QAPI update in 2019. During an interview on 08/11/2022 at 10:06 AM, the director of rehabilitation stated the policy titled, “Purpose,” was indeed the policy guiding the infection control program.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on policy review, employee Covid-19 vaccination record review, observation, and interview, the agency failed to provide infection control education to the staff. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: Review of the agency’s policy titled, “The Lutheran Home Staff Covid-19 Vaccination Policy,” dated/effective 12/05/2021, showed: - Employees, contract staff, and volunteers who do not meet the status of fully vaccinated must continue to abide by: * Masking, including, but not limited to, wearing a mask over the nose and mouth at all times while on duty regardless of workplace setting (except while eating); * Regularly cleaning and disinfecting workplace surfaces; and * Monitoring and reporting daily health symptoms and exposure. Review of the agency’s undated documents titled, “Request for Religious Exemption for the Covid-19 Vaccine,” and “Request for Medical Exemption for the Covid-19 Vaccine,” showed: - Question: If you receive an accommodation, how will you keep our residents, visitors, and employees safe?; * You will be required to wear a mask in the facility at all times in accordance with our mandated masking procedures; * You will not report to work if you have any signs and symptoms or have knowingly been in close contact with a Covid-positive person; * You may be required to take Covid-19 tests as needed for results to be documented; and - A signature line indicating the employee read and understood the waiver. Review of the undated document titled, “Purpose,” found in the policy section of the Infection Control Manual showed, in part: - Surveillance is ongoing and includes reviewing clinical observations; - The functions of the infection control committee include: * Assure that established policies are adhered to by staff; and * Assure adequate infection control education is presented to staff. Review of the agency’s employee Covid-19 vaccination files showed six out of eleven employees have a religious exemption and zero employees have a medical exemption for the Covid-19 vaccination. Employee A and Employee B were listed as having a religious exemption from vaccination. Observations of the agency staff on 08/08/2022 from 10:30 AM to 4:30 PM showed Employee A and Employee B were walking throughout the agency without masks while interacting in close proximity with other staff. During an interview on 08/09/2022 at 12:52 PM, the Employee B stated that staff do not have to wear a mask within the agency, they are only required to wear one if they are going to the long term care (LTC) portion of the facility. He/she stated that he/she was not aware that the agency’s policy requires unvaccinated staff to wear a mask at all times. He/she stated that they have all kinds of unvaccinated people walking around the agency without masks. Observation, immediately after the interview with Employee B (after employee was made aware of the policy’s requirements), showed him/her walking into the office with other employees. He/she was holding a mask in his/her hand but was not wearing a mask. During an interview on 08/09/2022 at 1:10 PM, Employee A stated that the agency’s vaccine policy states unvaccinated staff will test weekly and screen for symptoms but he/she does not think unvaccinated agency staff need to wear masks. He/she stated that he/she was not educated that masks were required for all unvaccinated staff and would look for an alternate policy. No further policy was provided. Employee A did not put on a mask when he/she learned of the policy requirements. Observations within the agency on 08/09/2022 from 2:00 PM to 4:30 PM and on 08/10/2022 from 3:00 PM to 5:00 PM showed Employee A and Employee B continued to move throughout the agency without masks in view of the COO. Employee B did put on a mask when he/she came in to speak with the surveyors. During an interview on 08/09/2022 at 3:00 PM, the chief operating officer (COO) stated that the religious and medical exemption waivers were updated in February 2022. The unvaccinated agency staff would have signed the old version of the waiver which does not contain the additional measures for unvaccinated employees. The agency staff probably did not know they were supposed to mask, if unvaccinated. He/she stated that the covid-19 vaccination policy is the current policy for all staff but the masking of unvaccinated staff at all times is something that is enforced more frequently in the LTC portion of the facility. No additional information was provided. During an interview on 08/11/2022 at 10:06 AM, the director of rehabilitation stated the policy titled, “Purpose,” was the policy guiding the infection control program.

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 policy review, employee record review, employee Covid-19 vaccination record review, observation, and interview, the agency failed to ensure skilled professional services were delivered according to the agency’s policies and procedures in, but not limited to, two (Employee A and Employee B) of eleven Covid-19 vaccination records reviewed and in one (Employee B) of four employee records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s policy titled, “The Lutheran Home Staff Covid-19 Vaccination Policy,” dated/effective 12/05/2021, showed: - Employees, contract staff, and volunteers who do not meet the status of fully vaccinated must continue to abide by: * Masking, including, but not limited to, wearing a mask over the nose and mouth at all times while on duty regardless of workplace setting (except while eating); * Regularly cleaning and disinfecting workplace surfaces; and * Monitoring and reporting daily health symptoms and exposure. Review of the undated document titled, “Purpose,” found in the policy section of the Infection Control Manual showed, in part: - Surveillance is ongoing and includes reviewing clinical observations; - The functions of the infection control committee include: * Assure that established policies are adhered to by staff; and * Assure adequate infection control education is presented to staff. Review of the agency’s employee Covid-19 vaccination files showed six out of eleven employees have a religious exemption and zero employees have a medical exemption for the Covid-19 vaccination. Employee A and Employee B were listed as having a religious exemption from vaccination. Observations of the agency staff on 08/08/2022 showed Employee A and Employee B walking throughout the agency without masks while interacting in close proximity with other staff. During an interview on 08/09/2022 at 12:52 PM, the Employee B stated that staff do not have to wear a mask within the agency, they are only required to wear one if they are going to the long term care (LTC) portion of the facility. He/she stated that he/she was not aware the agency’s policy requires unvaccinated staff to wear a mask at all times. He/she stated that they have all kinds of unvaccinated people walking around the agency without masks. Observation, immediately after the interview with Employee B (after employee became aware of the policy’s requirements), showed him/her walking into the office within close proximity of other employees. He/she was holding a mask in his/her hand but was not wearing a mask. During an interview on 08/09/2022 at 1:10 PM, Employee A stated that the agency’s vaccine policy states unvaccinated staff will test weekly and screen for symptoms but he/she does not think unvaccinated agency staff need to wear masks. He/she stated that he/she was not educated that masks were required for all unvaccinated staff and would look for an alternate policy. No further policy was provided. Employee A did not put on a mask when he/she learned of the policy requirements. Observations within the agency on 08/09/2022 from 2:00 PM to 4:30 PM and on 08/10/2022 from 3:00 PM to 5:00 PM showed Employee A and Employee B continued to move throughout the agency without masks in view of the COO. Employee B did put on a mask when he/she came in to speak with the surveyors. During an interview on 08/09/2022 at 3:00 PM, the chief operating officer (COO) stated that the covid-19 vaccination policy is the current policy for all staff but the masking of unvaccinated staff at all times is something that is enforced more frequently in the LTC portion of the facility and they need to make a policy specifically for home health. No additional information was provided. During an interview on 08/11/2022 at 10:06 AM, the director of rehabilitation stated the policy titled, “Purpose,” was the policy guiding the infection control program. Review of the agency’s policy titled, “Maintaining Current Registration of Nursing Staff,” dated/revised April 2003, showed, in part, that each nurse will: - Be responsible for maintaining a copy of his/her current Missouri registration in the nursing administrative office; - Provide a copy to the director of the home health agency; and - Present his/her new registration card to the nursing director and personnel office prior to the expirations of his/her current license. Review of the agency’s undated policy titled, “License, Registration and Certification,” showed, in part: - This policy applies to all employees whose position requires a license or registration; - Direct verification of current licensure will be conducted by the human resources department at the time of hire and annually, on or before the expiration date of the registration or license; and - The human resources department must ensure that a copy of the direct verification of credentials is current and maintained in the personnel file of the employee. Review of the agency’s employee records, requested on 08/09/2022 at 12:00 PM, showed, in part, the following: - Employee B was hired by the agency on 11/10/2017; - A license verification, dated/timed 10/31/2017 at 1:19 PM showed that Employee B’s nursing license had an expiration date of 04/30/2019; - A license verification that was dated/timed 08/09/2022 at 2:03 PM (2 hours after the employee files were requested); and - The agency failed to retain current licensure verifications, prior to expiration date, in Employee B’s personnel file. Findings were reviewed with the chief operating officer on 08/09/2022 at 2:30PM, the agency uses Nursys (an online quick confirm license verification site) to alert them to any licensure issues. No additional information was provided.

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 four Conditions of Participation: Patient Rights, Care Planning, Coordination of Services and Quality of Care, Infection Prevention and Control, and Organization and Administration of Services, 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 08/11/2024. .

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 policy review, job description review, review of the agency’s governing body minutes, and interview, the agency failed to meet the requirements for the Condition of Participation: Organization and Administration of Services. The agency failed to ensure: - The governing body assumed 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 (G0942); - The agency employs qualified personnel, including assuring the development of personnel qualifications and policies (G0952); and - When the administrator is not available, a qualified, predesignated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator (G0954). The cumulative effect of these systemic deficient practices resulted in the inability of the agency to provide effective ongoing management of all clinical services and to ensure the patient’s care needs would be met. .

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 policy review, review of the agency’s governing body minutes, and interview, the agency failed to ensure the governing body assumed full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, its operational plans, and its quality assessment and performance improvement (QAPI) program. This deficient practice has the potential to affect the care and safety of all patient’s served by the agency. Findings included: Review of the agency’s policy titled, “Functions of Governing Body,” dated/revised April 2003, showed the governing body: - Assumes full legal authority and responsibility for the operation of the agency; - Appoints a qualified administrator; - Arranges for professional advice as required; - Adopts and periodically reviews written by-laws; - Oversees the management and fiscal affairs of the agency; - Meets every month to set strategy and provide planning and direction of the agency; - Reviews, audits, and manages the fiscal affairs of the agency; and - Oversees the activities of all operations. Review of the agency’s governing body minutes from 01/26/2022 to 07/27/2022 showed: - The governing body minutes from the 07/27/2022 meeting contained documentation on the home health census and that the registered nurse had resigned; - There were no meeting minutes for June 2022; - The meeting minutes with dates ranging from 01/26/2022 to 05/25/2022 failed to contain any notes regarding the operations of the home health agency (HHA); - The governing body failed to assume full legal authority and responsibility for; * The management and operation of the HHA; * The provision of all home health services; * The operational plans of the HHA; and * The agency’s QAPI program. During an interview on 08/08/2022 at 3:00 PM, the chief operating officer (COO) stated that the governing body operates as a board but it is more of an advisory panel and home health gets a brief mention. The thoroughness of the meeting minutes leave something to be desired. He/she gives a brief home health presentation of census, number of patient’s receiving therapy, and any concerns/problems at each meeting.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on policy review, review of the agency’s governing body minutes, and interview, the agency failed to ensure the administrator reports to the governing body. This deficient practice has the potential to affect the provision of care to all patients served by the agency. Findings included: Review of the agency’s policy titled, “Administrator for Lutheran Home-Home Health,” dated/revised April 2003, showed, in part, that the administrator: - Organizes and directs the agency’s ongoing functions; and - Maintains ongoing liaison among the governing body, the group of professional personnel, and staff. Review of the agency’s governing body minutes, with dates ranging from 01/26/2022 to 07/27/2022, showed the agency failed to ensure the administrator reported directly to the governing body with no intermediaries. During an interview on 08/08/2022 at 3:00 PM, the chief operating officer stated that he/she is the one who presents directly to the governing body.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on policy review, job description review, employee record review, and interview, the agency failed to ensure a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator when the administrator is not available. This deficient practice has the potential to affect the provision of care to all patients served by the agency. Findings included: Review of the agency’s policy titled, “Home Health Administrator,” dated/revised 2015, showed the administrator has the following responsibilities: - Program and policy formulation for home health; - Plans overall development and administration of home health as set forth in the COP (Condition of Participation) and/or applicable state regulations under the direction of the board of directors; - Coordinates all home health services; - Develops an effective organizational structure within the home health; - Develops administrative policies and procedures relating to home health; - Knowledgeable of all home health services; - Able to organize and motivate people within the department to meet company objectives; - Coordinates annual program evaluation; - Demonstrates leadership qualities and has the ability to instill leadership qualities in others; - Able to read and interpret home health financial reports; - Informs staff of plans, problems, and progress; - Establishes standards of nursing practice and patient care standards; - Establishes job requirements, select staff, and participates in assignment of staff; - Supervises all therapeutic services offered by home health; - Establishes a system of on-going evaluation of staff and patient care; - Coordinates/participates in performance improvement program; - Attends and participates in staff meetings when indicated; - Keeps abreast of community developments and resources to provide adequate patient referrals; - Provides on-going educational programs for staff and patients; - Authorizes purchase of supplies and equipment; - Ensures proper maintenance of all medical records as prescribed and in compliance with local, state, and federal law; - Stays informed about changes in the field of nursing, home health care laws and regulations; and shares information with appropriate staff and administrative personnel; and - Assists in clinical record review. Review of the document titled, “Addendum to the Lutheran Home Board of Directors Meeting,” dated 12/27/2017, showed Employee B was appointed as the alternate administrator by the governing body. The document was not signed by the administrator. Review of the agency’s employee personnel files showed that the file for Employee B failed to contain: - Information that showed the employee received home health training; and - Information that showed the employee was informed of the job responsibilities of the alternate administrator. This surveyor entered the agency on 08/08/2022 at 10:30 AM and was greeted by office staff (OS) C. This staff member stated that the home health director was on vacation. OS C stated that he/she called Employee B to notify him/her of the surveyor’s arrival. On 08/08/2022 at 10:40 AM, Employee B greeted this surveyor and stated that he/she was the appointed alternate administrator but he/she does not know anything about home health, he/she only does hospice. The home health registered nurse and certified nursing assistant could get anything needed for the survey. On 08/08/2022 at 10:50 AM the chief operating officer (COO) greeted this surveyor and stated he/she is the administrator of the long term care facility and the COO. Employee B is the alternate administrator but home health is such a small entity that the director (who was on vacation) usually handles everything. Stated he/she would look for the board meeting minutes that show that Employee B was appointed as the alternate administrator. During an interview on 08/08/2022 at 11:00 AM, OS C stated that he/she was unsure who was designated as the alternate administrator but he/she always calls Employee B although Employee B primarily works as a nurse in hospice but there is also a home health nurse who would know more specifics regarding home health rules and procedures. OS C stated that he/she is not aware of a written chain of command in the absence of the director. He/she only knew by word of mouth. On 08/09/2022 at 9:30 AM, Employee B approached this surveyor and stated that he/she was going to go out and do his/her hospice nursing visits but would be back in the agency in the afternoon to do the administrator interviews. During an interview on 08/09/2022 at 2:00 PM, Employee B stated that he/she doesn’t know anything about home health but would try to answer the interview questions the best that he/she could. He/she doesn’t know about the day to day operations and still has to take care of the hospice patients, as well. The above findings were reviewed with the COO on 08/09/2022 at 2:30 PM. He/she stated that he/she has to trust that his/her supervisors are doing their jobs so, in a way, it has been a blessing that the director was on vacation because it has given him/her a chance to see what the supervisors are not doing.