Every finding on record at T.L.C. Home Healthcare, Inc

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to provide documented evidence of initial and ongoing training in Emergency Preparedness policies and procedures to all new and existing staff, including contract employees and volunteers as appropriate, and failed to maintain documentation of training's, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: On 3/2/23 at 9:30 a.m., the Agency's Administrator (Adm #1) was asked to provide evidence of initial training for all staff employed by this Agency, including contracted staff. Upon review of the requested documents, there was no indication that initial Emergency Preparedness training had been provided to all staff as required, and no sign-in sheet of all attendees. These findings were reviewed with and confirmed by Adm #1 during the interview on 3/2/23 who offered no response. The Agency failed to provide initial and ongoing training in Emergency Preparedness policies and procedures to all new and existing staff, including contract employees and volunteers as appropriate, and failed to maintain documentation of trainings.

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), §485.542(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, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to provide documentation for the required community/facility based full-scale exercises and failed to provide documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff being ill-prepared in the event of an actual emergency. This deficient practice could negatively affect all patients currently serviced by this Agency. Findings include: On 3/2/23 during review of the agency's Emergency Preparedness documents, it was noted that there was no evidence the Agency had conducted the required training or exercises to test the agencies Emergency plan. There was no evidence of staff participation, including contracted staff or volunteers as appropriate. There was no documentation of an actual event that would qualify as an emergency, no community based full-scale exercise, no second full-scale exercise or a table-top exercise. These findings were reviewed with and acknowledged by the Administrator during an interview on 3/2/23.

The following Condition and Standard level deficiencies were identified during a Medicare authorized Recertification survey, concurrent with the Vaccine Mandate protocol review and an Emergency Preparedness survey, conducted by the Michigan Department of Licensing and Regulatory Affairs on 2/28/23 through 3/3/23 at: TLC Home Healthcare, Inc. 30095 Northwestern Highway, Suite 60A Farmington Hills, MI 48334-3283 This Agency had no additional Branch locations. Services Provided: Skilled Nursing, Physical Therapy, Occupational Therapy, Speech Therapy, Medical Social Work, Home Health Aide. Records Reviewed: 2 Records with home visits; 5 Records without home visits, for a total of 7 records reviewed. Only 2 of the required 3 home visits could be conducted due to patient refusal. The following Conditions were identified: 42 CFR §484.55: Comprehensive Assessment of Patients 42 CFR §484.60: Care Planning, Coordination, Quality of Care 42 CFR §484.70: Infection Prevention and Control. 42 CFR §484.65: Quality Assessment/Performance Improvement. 42 CFR §484.105: Organization and Administration of Services. As a result of the Condition level noncompliance, the Agency is prohibited for 2 years, from the date of exit, from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

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 observation, interview and record review, the agency failed to ensure that 1 (MR #2) of 7 sampled records reviewed, were included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided and disciplines that will furnish care, resulting in a lack of inclusion in planning, lack of informed consent, the potential for missed visits and unmet care needs. Findings include: MR #2: The patient's start of care (SOC) was 1/26/23 with diagnoses that included Multiple Sclerosis, Congestive Heart Failure and diabetes Mellitus. The referral for home care ordered Skilled Nursing, Physical Therapy, Occupational Therapy and Home Health Aide services to be provided. On 3/1/23 at 11:30 a.m., a home visit was conducted with the Registered Nurse/Alternate Clinical Manager (CM #2). During a review of the patient's admission packet, it was noted that there was no calendar of proposed visits to be made by any of the above ordered disciplines. Prior to concluding the visit, the patient stated, "The Physical Therapist came by last night about 6:00 p.m. Our house is her last stop on her way home, so I guess it's convenient for her." CM #2 then stated, "I do that too." The Agency and its disciplines failed to ensure the patients were included in the overall planning of their care. These findings were reviewed with the Administrator and Alternate Clinical Manager during an interview on 3/1/23 at 3:31 p.m.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review, policy review and document review, the agency failed to ensure the Initial Comprehensive Assessment was conducted within 48 hours of the date of referral or discharge from an inpatient facility (refer to G-514); failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and history of events leading to current home care needs (refer to G-528); failed to ensure that patients who required assistance with grooming, had the Activities of Daily Living needs were adequately met in the patient's home (refer G-534); failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required and failed to ensure the physician was notified of potential drug interactions (refer to G-536); and failed to ensure the Comprehensive Assessment was updated and completed at the time of discharge from the agency's services in 1 (MR #1) of 2 discharged records, from a total of 7 sampled records reviewed (refer to G-550). The cumulative effect of these systemic problems resulted in the Home Health Agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR § 484.55: Comprehensive assessment of patients.

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 record review and interview, the Agency failed to ensure the Initial Comprehensive Assessment was conducted within 48 hours of the date of referral or discharge from an inpatient facility for 4 (MR's #1, 2, 6, 7) of 4 records reviewed where start of care services were delayed, from a total of 7 sampled records reviewed, resulting in delay in needed care and services and the potential for declining health status and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 11/26/22 with diagnoses that included Hypertensive Heart Disease. During the clinical record review on 2/28/23 at 2:45 p.m., it was noted that the referral for home care was dated 11/22/22 and ordered Occupational Therapy, (OT), Physical Therapy (PT), Skilled Nursing (SN) and Home Health Aide (HHa) services to be provided. The SOC was 4 days after the date of the referral. The Agency failed to ensure the Initial SOC was conducted within 48 hours (2 days) from the date of the referral. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 3/1/23 at 2:45 p.m. MR #2: The patient's SOC was 1/26/23 with diagnoses that included Multiple Sclerosis, Congestive Heart Failure and Diabetes Mellitus. During the record review on 3/1/23 at 10:15 a.m., it was noted that the referral for home care was dated 1/13/23 and ordered SN, PT, OT and HHa services to be provided. The SOC was conducted on 1/26/23, which was 13 days after the date of the referral. The Agency failed to ensure the Initial SOC was conducted within 48 hours (2 days) from the date of the referral. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 3/1/23 at 3:31 p.m. MR#6: The Start of Care (SOC) was dated 1/5/2023. The Plan of Care (POC) for the certification period 1/5/23 to 3/5/23 identified diagnoses of Primary osteoarthritis, Pain in right knee, Hypertension (HTN), Hypocalcemia, Chronic Kidney Disease (CKD), and Concussion with Loss of Consciousness (LOC). The physician ordered a Start of Care date of 12/28/22, however the Start of Care was conducted on 1/5/22, 8 days after the physician ordered Start of Care date. There was no communication or orders found in the record to delay the Start of Care, nor was there a documented request by the patient to delay the Start of Care. MR#7: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the certification period 1/19/2023 to 3/19/2023 identified primary diagnoses of Diabetes Type 2 (DM2), along with diagnoses of Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Abnormality of gait, post-Covid-19 Condition, and Long-term use of Insulin. This patient was discharged from an Inpatient Rehabilitation Hospital (IRF) on 1/16/2023. The Start of Care Assessment was completed on 1/19/2023, 36 hours after the discharge from the Inpatient Rehabilitation Hospital. There were no physician orders found in the record that indicated a need to delay the SOC assessment after the patient was released from the Inpatient Rehabilitation Facility nor was there a documented request by the patient to delay the Start of Care. The Agency failed to complete the Start of Care Assessment within 48 hours of discharge from an inpatient medical facility. These finding was reviewed and acknowledged by the Administrator and Clinical Manager during an interview on 3/3/23 at 2:30 p.m.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review, and interview, the Agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and history of events leading to current home care needs in 4 of 7 records (MR#s 4, 5, 6, 7) reviewed, resulting in incomplete and inaccurate clinical information to aide in determining the needs of the patient. Findings included: MR#4: The Start of Care (SOC) was dated 1/24/2023. The Plan of Care (POC) for the certification period 1/24/2023 to 3/24/2023 identified diagnoses of Chronic Pain, Low Back Pain, Hypertension (HTN), Diabetes type 2 (DM2), Asthma, Osteoporosis, and Low vision. The POC documented the patient was receiving Skilled Nursing (SN) to Evaluate and Treat, and Physical Therapy (PT) services 1xweekx1week and 2xweekx6weeks. The SOC assessment documented the patient had refused Occupational Therapy (OT) and Medical Social Work (MSW) services. However, the Physical Therapist (PT) rather than the SN completed the SOC Comprehensive Assessment on 1/24/2023 and failed to sign their name on the Comprehensive Assessment. In addition, it was noted the PT did not document a complete Comprehensive Assessment that accurately reflected the patient's current health status. The following information was documented as "skip answer": "M0064 Patient's Social Security Number; M0104 Date of Referral; M1005 Inpatient Discharge Date; D150C1 Trouble falling or staying asleep or sleeping too much; D0140D1 Feeling tired or having little energy; D0150D2 Symptom Frequency; D0150E1E. Poor appetite or overeating; D0150E1 Symptom Frequency; D0150F1 Feeling bad about yourself-or that you are a failure or have let yourself or your family down; D0150F2 System Frequency; D0150G1 Feeling bad about yourself-or that you are a failure or have let yourself or your family down; D0150F2 Symptom Frequency; D0150G1 Trouble concentrating on things, such as reading the newspaper or watching TV; D0150G2 Symptom Frequency; D0150H1 Moving or speaking so slowly that other people could have noticed. Or opposite-being so fidgety or restless that you have been moving around a lot more than usual; D0150H2 Symptom Frequency; D0150HI1 Thoughts that you would be better off dead or hurting yourself in some way; D0150I2 Symptom Frequency. This entire area of mental health was left without evaluation at the Start of Care. There was no history of how long the patient had any of the above stated diseases/conditions, no dates of onset documented, or when and how the diseases occurred and if they were chronic or resolved. There was no history of the status of the above diseases including treatments for past medical problems and outcomes of those treatments. There was no documented evidence of an assessment of the events that led to the home care referral, no date for the referral, and no assessment of the patient's specific current home care needs. MR#5: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the Certification Period 1/19/2023 to 3/19/2023 identified diagnoses of Diabetes type 2 (DM2), Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Chronic Pain, Abnormalities of gait, and Post Covid-19. The patient was receiving Physical Therapy Services (PT) 1xweekx1week, and 2xweekx6weeks.The following information was documented as "skip answer": "M0064 Patient's Social Security Number; M0104 Date of Referral; D0150C1 Trouble falling or staying asleep, or sleeping too much; D0150C2 Symptom frequency; D0150D1 Feeling tired or having little energy; D0150D1 Symptom frequency; D0150E1 Poor appetite or overeating; D0150E2 Symptom Frequency; D0150F1 Feeling bad about yourself-or that you are a failure or have let yourself or family down; D0150F2 Symptom frequency; D0150G1 Trouble concentrating on things, such as reading the newspaper or watching television; D0150G2 Symptom Frequency; D0150H1 Moving or speaking so slowly that other people could have noticed. Or opposite-being so fidgety or restless that you have been moving around a lot more than usual; D0150H2 Symptom Frequency; D0150HI1 Thoughts that you would be better off dead or hurting yourself in some way; D0150I2 Symptom Frequency. This entire area of mental health was left without evaluation at the Start of Care. There was no history of how long the patient had any of the above stated diseases/conditions, no dates of onset documented, or when and how the diseases occurred and if they were chronic or resolved. There was no history of the status of the above diseases including treatments for past medical problems and outcomes of those treatments. There was no documented evidence of an assessment of the events that led to the home care referral, no date for the referral, and no assessment of the patient's specific current home care needs. MR#6: The Start of Care (SOC) was dated 1/5/2023. The Plan of Care (POC) for the certification period 1/5/23 to 3/5/23 identified diagnoses of Primary osteoarthritis, Pain in right knee, Hypertension (HTN), Hypocalcemia, Chronic Kidney Disease (CKD), and Concussion with Loss of Consciousness (LOC). This patient was discharged from a short-stay acute hospital on 12/28/2022 due to a fall that resulted in a hospitalization due to a Concussion with Loss of Consciousness. The patient was receiving Skilled Nurse (SN) services 1xweek for (number of weeks not documented), Physical Therapy Services to Evaluate and Treat, and Occupational Therapy was refused. Upon review of the record, it was noted the SN did not document a complete Comprehensive Assessment that accurately reflected the patient's current health status. The following information was documented as "skip answer": "M0064 Patient's Social Security Number; M0104 Date of Referral; GG0170 Walk 50 feet with two turns; GG0170K1: Walk 150 feet: once standing, the ability to walk at least 150 feet in a corridor; GG0170L1: Walking 10 feet on uneven surfaces: The ability to walk 10 feet on uneven or sloping surfaces; GG0170N1: The ability to go up and down four steps with or without a rail; GG0170O1: The ability to go up and down 12 steps with or without a rail. Under category of "Emotions, Evidence of abuse/neglect/exploitation, this area of the assessment was blank. There was no history of how long the patient had any of the above stated diseases/conditions, the dates of onset were documented as same date of 1/5/23. There was no documentation of when and how the diseases occurred and if they were chronic or resolved. There was no history of the status of the above diseases including treatments for past medical problems and outcomes of those treatments. There was no documented evidence of an assessment of the events that led to the home care referral, no date for the referral, and no assessment of the patient's specific current home care needs. MR#7: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the certification period 1/19/2023 to 3/19/2023 identified diagnoses of Diabetes Type 2 (DM2), Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Abnormality of gait, post-Covid-19 Condition, and Long-term use of Insulin. The patient was receiving Skilled Nurse Services 2 x week for 1 week and 1 x week for 4 weeks; and Physical Therapy Services 1xweek for 1 week and 2xweek for 6 weeks. Upon review of the Comprehensive Assessment, it was noted the SN did not document a complete Comprehensive Assessment that accurately reflected the patient's current health status. The following information was either not addressed or documented as "skip answer": D0150C1 Trouble falling or staying asleep, or sleeping too much; D0150C2 Symptom frequency; D0150D1 Feeling tired or having little energy; D0150D1 Symptom frequency; D0150E1 Poor appetite or overeating; D0150E2 Symptom Frequency; D0150F1 Feeling bad about yourself-or that you are a failure or have let yourself or family down; D0150F2 Symptom frequency; D0150G1 Trouble concentrating on things, such as reading the newspaper or watching television; D0150G2 Symptom Frequency; D0150H1 Moving or speaking so slowly that other people could have noticed, or opposite-being so fidgety or restless that you have been moving around a lot more than usual; D0150H2 Symptom Frequency; D0150HI1 Thoughts that you would be better off dead or hurting yourself in some way; D0150I2 Symptom Frequency. This entire area of mental health was left without evaluation at the Start of Care. There was no history of how long the patient had any of the above stated diseases/conditions, no specific dates of onset documented, all dates of onset were the same date of 1/19/2023, or when and how the diseases occurred and if they were chronic or resolved. There was no history of the status of the above diseases including treatments for past medical problems and outcomes of those treatments. There was no documented evidence of an assessment of the events that led to the home care referral, no date for the referral, and no assessment of the patient's specific current home care needs. These findings were reviewed and acknowledged during an interview with the Administrator, Clinical Manager, and Director of Nursing on 3/6/2023 at 2:30 p.m.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that 6 (MR's #1, 2, 3, 4, 5 and 6) of 6 patients who required assistance with grooming, had the Activities of Daily Living needs adequately met in the patient's home, from a total of 7 sampled records reviewed, resulting in the potential for poor hygiene, loss of self-esteem and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 11/26/22 with diagnoses that included Hypertensive Heart Disease. During the clinical record review on 2/28/23 at 2:45 p.m., it was noted that the referral for home care dated 11/22/22 ordered Occupational Therapy (OT, Physical Therapy (PT), Skilled Nursing (SN) and Home Health Aide (HHa) services to be provided. Section M1800 of the Initial Comprehensive Assessment dated 11/26/22 documented, "Someone must assist the patient to groom self..., Patient depends entirely upon another person to dress..." At the time of this review, no Home Health Aide services had been provided as ordered in order to meet the Activity of Daily Living (ADL) needs of the patient. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 3/1/23 at 2:45 p.m. MR #2: The patient's SOC was 1/26/23 with diagnoses that included Multiple Sclerosis, Congestive Heart Failure and Diabetes Mellitus. During the record review on 3/1/23 at 10:15 a.m., the referral for home care dated 1/13/23 ordered SN, OT, PT and HHa services to be provided. Section M1800 of the Comprehensive Assessment documented, "Someone must assist the patient to groom self..., Patient depends entirely upon another person to dress lower body..., someone must help the patient to maintain toileting hygiene..." At the time of this review, no Home Health Aide services had been provided as ordered in order to meet the ADL needs of the patient. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 3/1/23 at 3:31 p.m. MR #3: The patient's SOC was 2/21/23 with diagnoses that included Hypertension, Diabetes and Atherosclerotic Heart Disease. During the record review on 3/2/23 at 1:55 p.m., the referral for home care dated 2/20/23 ordered SN, OT and PT services to be provided. section M1800 of the Initial Comprehensive Assessment documented that the patient required assistance with grooming, dressing and toileting hygiene. At the time of this review, there was no documented evidence that a Home Health Aide had been offered to assist with meeting the patient's ADL needs. these findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 3/3/23 at 10:05 a.m. MR#4: The Start of Care (SOC) was dated 1/24/2023. The Plan of Care (POC) for the certification period 1/24/2023 to 3/24/2023 identified diagnoses of Chronic Pain, Low Back Pain, Hypertension (HTN), Diabetes type 2 (DM2), Asthma, Osteoporosis, and Low vision. Upon review of the Start of Care Assessment it was noted the Physical Therapy Evaluation documented the patient was, "Dependent upon adaptive device such as Walker, light weight wheelchair, was a one person assist for transfer, the patient had decreased balance and endurance, and under the Category of "Patient Living Situation" it was documented that the patient "lives with other person in the home around the clock", and that "a non-agency caregiver needs training/supportive services to provide assistance." The Plan of Care identified under safety measures that the patient uses a wheelchair or walker. Under the Category of "Functional Status," it was documented, under M1800-Grooming: "Someone must assist the patient to groom self; M1810: Someone must help the patient put on upper body clothing; M1820: Someone must help the patient put on undergarments, slack, socks, or nylons, and shoes; under M1830: Unable to use the shower or tub, but able to participate in bathing self in bed, at the sink, in bedside chair, or on commode, with the assistance or supervision of another person; M-1840 Toilet Transferring: Unable to get to and from the toilet but is able to use a bedside commode; M1845 Toileting Hygiene: Someone must help the patient to maintain toileting hygiene and/or adjust clothing; M1850: Able to bear weight and pivot during the transfer process but unable to transfer self; and under M1860: Able to walk only with the supervision or assistance of another person at all times. It was noted that the agency failed to provide home health aide services to assist the patient with personal care needs while home health care services were provided by the agency, despite the fact that these ambulatory and personal care needs had been identified on the Start of Care Assessment. MR#5: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the Certification Period 1/19/2023 to 3/19/2023 identified diagnoses of Diabetes type 2 (DM2) with neuropathy, Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Chronic Pain, Abnormalities of gait, and Post Covid-19. The patient was receiving Skilled Nursing 2xweekx1, and once a week for 4 weeks. Physical Therapy Services was ordered 1xweekx1week, and every 2 weeks for 6 weeks for gait instability; strength and endurance, fatigue, and basic self-care. The Plan of Care identified that the patient had a sprained ankle. This patient had a history of falling, history of TIA (transient ischemic attacks), and cerebral infarction. Safety Measures included: Safety in Activities of Daily Living, fall precautions, slow position change, support during transfer and ambulation, ambulate within limits of endurance, keep pathways clear, and use of assistive devices. The patient's goal was to "walk within the house between bedroom, living room, and toilet; get into the shower without pain and without fear of falling." The patient has a wheelchair. Leaving home is medically contraindicated due to the patient needing assistance for all activities, and is unable to ambulate unassisted, and is a high fall risk. Upon review of the comprehensive assessment under the Category of "Patient Living Situation" it was documented that the patient "lives alone with occasional/short-term assistance", and that "a non-agency caregiver needs training/supportive services to provide assistance." Under the Category of "Functional Status," it was documented, under M1800-Grooming: "Someone must assist the patient to groom self; M1810: Someone must help the patient put on upper body clothing; M1820: Someone must help the patient put on undergarments, slack, socks, or nylons, and shoes; under M1830: Unable to use the shower or tub, but able to participate in bathing self in bed, at the sink, in bedside chair, or on commode, with the assistance or supervision of another person; M-1840 Toilet Transferring: Unable to get to and from the toilet but is able to use a bedside commode; M1845 Toileting Hygiene: Someone must help the patient to maintain toileting hygiene and/or adjust clothing; M1850: Able to bear weight and pivot during the transfer process but unable to transfer self; and under M1860: Able to walk only with the supervision or assistance of another person at all times. It was noted that the agency failed to provide home health aide services to assist the patient with personal care needs while home health care services were provided by the agency, despite the fact that these ambulatory and personal care needs had been identified on the Start of Care Assessment. MR#6: The Start of Care (SOC) was dated 1/5/2023. The Plan of Care (POC) for the certification period 1/5/23 to 3/5/23 identified diagnoses of Primary osteoarthritis, Pain in right knee, Hypertension (HTN), Hypocalcemia, Chronic Kidney Disease (CKD), and Concussion with Loss of Consciousness (LOC). The patient was receiving Skilled Nurse (SN) Services and Physical Therapy (PT) services. This patient was discharged from a short-stay acute hospital on 12/28/2022 due to a fall that resulted in Loss of Consciousness and a Concussion. Upon review of the Start of Care Assessment under the Category of "Patient Living Situation" it was documented that the patient "lives alone around the clock", and it was documented that "a non-agency caregiver is not likely to provide assistance, or it is unclear if they will provide services." The Plan of Care identified under safety measures that the patient uses a cane or walker, grab bars, a bath bench, and needs support during transfer and ambulation." The POC also indicates that this patient is unable to walk for more than 20 feet without aids and another person due to pain and generalized weakness. Under the Category of "Functional Status," it was documented, under M1800: "Someone must assist the patient to groom self; M1810: Someone must help the patient put on upper body clothing; M1820: Someone must help the patient put on undergarments, slack, socks, or nylons, and shoes; under M1830: Unable to use the shower or tub, but able to participate in bathing self in bed, at the sink, in bedside chair, or on commode, with the assistance or supervision of another person; M1845 Toileting Hygiene: Someone must help the patient to maintain toileting hygiene and/or adjust clothing; M1850: Unable to transfer self and is unable to bear weight or pivot when transferred by another person; and under M1860: Able to walk only with the supervision or assistance of another person at all times. It was noted that the agency failed to provide home health aide services to assist the patient with personal care needs after the patient's discharge from the hospital despite the fact that these ambulatory and personal care needs had been identified on the Start of Care Assessment. These findings were reviewed and acknowledged by the Administrator (ADM-1) and Clinical Manager (CM-1) during an interview on 3/6/2023 at 2:30 p.m.

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 record review and interview, it was determined the agency failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review as required and failed to ensure the physician was notified of potential drug interactions in 2 (MR's #1, 3) of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all patients currently serviced by this Agency. Findings include: MR #1: The patient's start of care (SOC) was 11/26/22 with diagnoses that included Hypertensive Heart disease. Section M2001 of the Initial comprehensive Assessment dated 11/26/22, completed by the Nurse documented, "No issues found during review." During the record review on 2/28/23 at 2:45 p.m., an Agency generated drug interaction report revealed the presence of 2 major drug to drug interactions. There was no indication that a comprehensive drug review had been conducted in accordance with this requirement. Further, there was no documented evidence that the Physician had been made aware of these untoward drug interactions. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 3/1/23 at 3:13 p.m. MR #3: The patient's SOC was 2/21/23 with diagnoses that included Hypertension and Diabetes Mellitus. Section M2001 of the Initial Comprehensive Assessment dated 2/21/23, completed by the Registered Nurse (CM #2) documented, "Yes, issues found during the review." On 3/2/23 at 1:55 p.m., during a review of the clinical record, there was no documented evidence of what issues had been identified. Additionally, the patient's incoming referral paperwork listed 15 prescription medications. CM #2 failed to ensure the medications were listed on the medication profile. Upon further review, there was no documented evidence that the Agency conducted a comprehensive review of all the patient's prescribed medications, documented the findings and informed the Physician of the findings as appropriate. These findings were reviewed with and acknowledged by the Administrator (Adm #1), Clinical Manager (CM #1) and the Alternate Clinical Manager (CM #2), who was present during the interview, during an interview on 3/3/23 at 10:05 a.m..

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Comprehensive Assessment was updated and completed at the time of discharge from the agency's services in 1 (MR #1) of 2 discharged records, from a total of 7 sampled records reviewed, resulting in no indication of the patient’s progression towards their identified goals and the potential for unmet continuing care needs. Findings include: MR #1: The patient's start of care was 11/26/22 with diagnoses that included Hypertensive Heart Disease. During the clinical record review on 2/28/23 at 2:45 p.m., it was noted that the plan of care ordered Occupational Therapy, Skilled Nursing, Physical Therapy and Home Health Aide services to be provided. It was further noted that the patient was discharged from the Agency's services on 12/10/22. No Discharge Oasis had been completed at the time of this review. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/1/23 at 3:13 p.m.

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 record review and interview, the agency failed to develop a plan of care that included objectively measurable goals in 4 of 7 records (MR#s 4, 5, 6 and 7); and failed to ensure the patient received care and services as ordered in the plan of care for 1 (MR #2) record, resulting in the inability to determine the patient's progress towards achieving goals and the potential for unmet care needs (G572); failed to ensure the plan of care covered all pertinent interventions with reportable parameters, safety precautions and objectively measurable goals specific to the needs of the patient in 5 (MR's # 1, 2, 3, 4, 7) of 5 records, from a total of 7 sampled records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes (G574); failed to record all patient care orders in the Plan of Care in 1 of 7 (MR#7) records reviewed, resulting in lack of services provided as ordered by the physician (G576); failed to provide services as ordered by the physician in 1 of 7 records (MR#7) reviewed, resulting in services not provided as ordered by the physician (G578); failed to provide a written copy of the home exercise program prescribed by the physical therapist to aid the patient in performing the prescribed physical therapy exercises between scheduled physical therapy visits in 1 of 2 records reviewed (MR#7) in which Physical Therapy Home visits were provided of a total of 2 records reviewed with home visits, resulting in the inability for the patient to perform the exercises on the days in which the Physical Therapist was not scheduled for home visits (G618). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR§484.60 Care Planning, Coordination, Quality of Care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop a plan of care that included objectively measurable goals in 4 of 7 records (MR#s 4, 5, 6 and 7); and failed to ensure the patient received care and services as ordered in the plan of care for 1 (MR #2) record, resulting in the inability to determine the patient's progress towards achieving goals and the potential for unmet care needs. Findings included: MR#4: The Start of Care (SOC) was dated 1/24/2023. The Plan of Care (POC) for the certification period 1/24/2023 to 3/24/2023 identified diagnoses of Chronic Pain, Low Back Pain, Hypertension (HTN), Diabetes type 2 (DM2), Asthma, Osteoporosis, and Low vision. Upon review of the POC, it was noted the goals on the POC were not objectively measurable to determine the patient's progress towards achieving the goals. Examples included: "Discharge when optimal function attained with: Good Rehab Potential." This goal is not objectively measurable to determine the patient's progress achieving the towards goals. MR#5: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the Certification Period 1/19/2023 to 3/19/2023 identified diagnoses of Diabetes type 2 (DM2), Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Chronic Pain, Abnormalities of gait, and Post Covid-19. Upon review of the POC, it was noted the goals on the POC were not objectively measurable to determine the Patient's progress towards achieving the goals. Examples included: "Discharge when optimal function attained with: Family, Assist, Discharge when independent with Physician follow-up in 5 weeks, Plan of Treatment to be re-evaluated in 4 Weeks, Discharge when all goals have been met, fair rehab" {sic} These goals are not objectively measurable to determine the patient's progress towards obtaining the goals. MR#6: The Start of Care (SOC) was dated 1/5/2023. The Plan of Care (POC) for the certification period 1/5/23 to 3/5/23 identified diagnoses of Primary osteoarthritis, Pain in right knee, Hypertension (HTN), Hypocalcemia, Chronic Kidney Disease (CKD), and Concussion with Loss of Consciousness (LOC). Upon review of the record, it was noted the goals on the POC were not objectively measurable to determine the patient's progress towards achieving goals. Examples included: "Discharge when optimal function attained, Discharge when independent with physician follow up in 4, Plan of Treatment to be re-evaluated in, Discharge when all goals have been met." {sic} These goals are not objectively measurable to determine the patient's progress towards achieving the goals. MR#7: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the certification period 1/19/2023 to 3/19/2023 identified diagnoses of Diabetes Type 2 (DM2), Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Abnormality of gait, post-Covid-19 Condition, and Long-term use of Insulin. Upon review of the goals on the POC, it was noted goals were not objectively measurable to determine the patient's progress towards achieving the goals. Examples included: "Discharge when optimal function attained with: Family assist; Discharge when independent with Physician follow-up in 5 weeks; Plan of Treatment to be re-evaluated in Weeks 4; and Discharge when all goals have been met; Fair Rehab" {sic}. These goals are not objectively measurable to determine the patient's progress towards achieving the goals. These findings were reviewed and acknowledged during an interview with the Administrator and Director of Nursing on 3/6/2023 at 2:30 p.m. MR #2: The patient's start of care was 1/26/23 with diagnoses that included Multiple Sclerosis, Congestive Heart Failure and diabetes Mellitus. The referral for home care dated 1/13/23 ordered Skilled Nursing (1W1, 2W1, 1W2) and Physical Therapy (2W5) services to be provided. During the record review on 3/1/23 at 10:15 a.m., it was noted that Skilled Nursing missed 1 of 2 ordered visits the week of 1/29/23. There was no evidence of an attempt to reschedule the visit. Further review revealed that the Physical Therapist began seeing the patient on 2/14/23; this was 19 days after the start of care. There was no documented evidence that the patient requested to delay services or that the Physician had been notified of the delay. The Agency failed to ensure care and services were provided as indicated in the plan of care. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/1/23 at 3:31 p.m.

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 record review and interview, the Agency failed to ensure the plan of care covered all pertinent interventions with reportable parameters, safety precautions and objectively measurable goals specific to the needs of the patient in 5 (MR's # 1, 2, 3, 4, 7) of 5 records, from a total of 7 sampled records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes. Findings include: MR#4: The Start of Care (SOC) was dated 1/24/2023. The Plan of Care (POC) for the certification period 1/24/2023 to 3/24/2023 identified diagnoses of Chronic Pain, Low Back Pain, Hypertension (HTN), Diabetes type 2 (DM2), Asthma, Osteoporosis, and Low vision. The patient was currently prescribed 2 injectable diabetic medications, Humalog (4xper day) and Glargine once daily. Upon review of the POC on 3/1/23, it was noted that the POC failed to include safety measures including a sharps container to safely dispose of the needles used to inject the patient's daily insulin. In addition, the POC failed to include reportable parameters for the patient's diagnoses of Diabetes, Hypertension, and Pain. MR#7: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the certification period 1/19/2023 to 3/19/2023 identified primary diagnoses of Diabetes Type 2 (DM2), along with diagnoses of Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Abnormality of gait, post-Covid-19 Condition, and Long-term use of Insulin. The patient was currently prescribed 2 injectable diabetic medications as follows: Humalog 35 units 3xday before meals and Levemir, 60ml subcutaneous every evening. Upon review of the POC on 3/1/23, it was noted that the POC failed to include safety measures including a sharps container to safely dispose of the needles used to inject the patient's daily insulins. In addition, the Plan of Care failed to include reportable parameters for the patient's diagnoses of diabetes, hypertension, and pain. These findings were reviewed with the Administrator and Clinical Director during an interview on 3/3/23 at 2:30 p.m. MR #1: The patient's start of care (SOC) was 11/26/22 with diagnoses that included Hypertensive Heart Disease. During the clinical record review on 2/28/23 at 2:45 p.m., it was noted that the plan of care (POC) ordered Occupational Therapy (OT), Skilled Nursing (SN), Physical Therapy (PT) and Home Health Aide (HHa) services to be provided. The POC revealed the following: All the listed diagnoses had an exacerbation date of 11/26/22. There were no interventions, reportable parameters or associated, measurable goals that addressed any of the listed diagnoses. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/1/23 at 3:13 p.m. MR #2: The patient's SOC was 1/26/23 with diagnoses that included Multiple Sclerosis, Congestive Heart Failure and Diabetes Mellitus. During the record review on 3/1/23 at 10:15 a.m., it was noted that the POC ordered SN, PT, OT and HHa services to be provided. The POC revealed the following: All the listed diagnoses had an exacerbation date of 1/26/23. There were no interventions, reportable parameters or associated, measurable goals that addressed any of the listed diagnoses. The POC was vague in nature and documented, "CHF Mgt. and when to call PCP..., The POC was void of appropriate guidance to manage the identified conditions/diagnoses. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/1/23 at 3:31 p.m. MR #3: The patient's SOC was 2/21/23 with diagnoses that included Hypertension and Diabetes Mellitus. During the clinical record review on 3/2/23 at 1:55 p.m., it was noted that the POC ordered SN, PT and OT services to be provided. The referral paperwork listed the patient's 15 prescribed medications, however, none of the medications were listed on the POC. Further, the POC was vague and documented, "Interventions to address underlying risk factors.., CHF symptoms or change in behavior..." The POC was void of guidance that directed staff on the care and management of the patient's condition. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/3/23 at 10:05 a.m.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to record all patient care orders in the Plan of Care in 1 of 7 (MR#7) records reviewed, resulting in lack of services provided as ordered by the physician. Findings included: MR#7: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the certification period 1/19/2023 to 3/19/2023 identified primary diagnoses of Diabetes Type 2 (DM2), along with diagnoses of Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Abnormality of gait, post-Covid-19 Condition, and Long-term use of Insulin. Upon review of the record, it was noted a physician order dated 2/21/2023 that included orders for Services to be provided for Skilled Nursing, Physical Therapy, and Certified Aide Services. The order was read back and verified with the physician by the Clinical manager on 2/21/2023 at 02:30 PM. The Patient and Caregiver were notified and instructed of the changes and the order was acknowledged per signature of the Clinical Manager and dated 2/21/2023 at 2:30 p.m. The order was read back and verified by the physician with an effective date of 2/21/2023. However, the Plan of Care was not revised to include the addition of Certified Aide Services. Further review of the record on 3/3/2023 revealed that Certified Aide Services had not been included on the Plan of Care or provided or refused by the family. The Plan of Care had not been updated to include the addition of Certified Aide Services.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide services as ordered by the physician in 1 of 7 records (MR#7) reviewed, resulting in services not provided as ordered by the physician. Findings included: MR#7: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the certification period 1/19/2023 to 3/19/2023 identified primary diagnoses of Diabetes Type 2 (DM2), along with diagnoses of Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Abnormality of gait, post-Covid-19 Condition, and Long-term use of Insulin. Upon review of the record, it was noted that a physician order dated 2/21/23 was acknowledged and signed by the Clinical Manager on 2/21/23 at 2:30 p.m. The order was read back and verified with the physician by the Clinical Manager. The order included notification of updates to the patient's Condition/Clinical Status, updated medication list, and Services to be provided for Skilled Nursing Physical Therapy, and Certified Nurse Aide Services. Upon review of the record on 3/3/2023, it was noted that Certified Aide Services had not been provided. There was no documentation that the patient/family had refused services, nor were there updates to the Plan of Care that included frequency and duration of Certified Nurse Aide Services. These findings were reviewed and acknowledged with the Administrator and Clinical Manager on 3/3/23 at 2:30 p.m.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the physical therapist failed to provide a written copy of the home exercise program prescribed by the physical therapist to aid the patient in performing the prescribed physical therapy exercises between scheduled physical therapy visits in 1 of 2 records reviewed (MR#7) in which Physical Therapy Home visits were provided of a total of 2 records reviewed with home visits, resulting in the inability for the patient to perform the exercises on the days in which the Physical Therapist was not scheduled for home visits. Findings included: MR#7: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the certification period 1/19/2023 to 3/19/2023 identified diagnoses of Diabetes Type 2 (DM2), Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Abnormality of gait, post-Covid-19 Condition, and Long-term use of Insulin. During a joint survey home visit with the Physical Therapist, PT#1, PT# was observed coaching the patient through an exercise program prescribed by Pt#1. Upon exiting the patient's home, the PT was queried if there was a written copy of the exercise program left in the home to ensure the patient was performing the exercises on a daily basis while in the absence of the physical therapist? The response was "no, but that would be a good thing to provide, I will give the patient a written copy of the exercises on my next home visit." The agency failed to provide the patient with a written copy of the prescribed home exercise program. This finding was reviewed and acknowledged by the Administrator (ADM#1) and Clinical Manager (CM#2) during an interview on 3/3/2023 at 2:30 p.m.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record reviewed and Interview, the Agency failed to develop a Quality Assessment Performance Improvement (QAPI) Program to optimize the agency's patient outcomes (See G-642); failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program to ensure the effectiveness and safety of services, quality of care, and to identify opportunities for improvement (See G-644); failed to initiate a Performance Improvement Program (PIP) within their QAPI program that focused on high risk, high volume, or problem prone areas (See G-646); failed to initiate any performance improvement activities within their QAPI program that focused on high risk, high volume, or problem prone areas (See G-648); failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement Program (QAPI), that addressed incidence, prevalence, and severity of problems identified amongst the agency's own patient population as areas of focus to improve patient care (See G-654); failed to conduct a performance improvement project for the year 2023 (See-G 658); failed to ensure a Performance Improvement Program for quality improvement and patient safety is approved by the Governing Body, defined, implemented, maintained, addresses priorities for improved quality of care, patient safety, and that all improvement actions are evaluated for effectiveness (See-G660). The cumulative effect of these systemic problems resulted in the Home Health Agency’s inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR § 484.65: Quality Assessment and Performance Improvement.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record reviewed and Interview, the Agency failed to develop a Quality Assessment Performance Improvement (QAPI) Program to optimize the agency's patient outcomes. This practice could affect all of the agency's patients admitted to the agency. Findings included: Upon review of the agency's QAPI Program on 3/2/2023 it was discovered that the agency failed to initiate a QAPI program based on monitoring adverse or negative patient outcomes or processes the agency wishes to measure for improvements. There was no evidence that any data was collected based on the agency's own patient population and record keeping in determining a need for a coordinated agency-wide program for the surveillance investigation, identification, and prevention of future negative outcomes. These findings were reviewed and acknowledged by the Administrator (ADM) on 3/3/2023 at 2:30 p.m.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program to ensure the effectiveness and safety of services, quality of care, and to identify opportunities for improvement. Findings included: During a review of the Agency QAPI Program on 3/2/2023, it was noted that there was no evidence the agency had developed a QAPI program that included methods to collect and monitor its own patient data to use as a comparison to national performance, to ensure the safety of patients and the quality of care provided by this agency. There was also no indication that the Governing Board had approved the manner, frequency, and detail of patient data collection as a measurement to identify improvement in patient care. A review of the Governing Board Meeting Minutes for the year 2022 failed to reveal documentation of a discussion to approve a Quality Assessment and Performance Improvement Project for the year 2023. This finding was reviewed and acknowledged by the Administrator and Director of Operations during an interview on 3/3/2023 at 2:30 p.m.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to initiate a Performance Improvement Program (PIP) within their QAPI program that focused on high risk, high volume, or problem prone areas, resulting in the potential for agency issues with negative consequences for high risk, high volume, or problem prone areas that could affect all patients served by the agency. Findings included: During an interview on 3/3/23 at 1:00 p.m., the Administrator was queried about the Performance Improvement Program (PIP) activities the agency was conducting. The response was, "we do chart reviews." When asked what Performance Improvement Project was presented to the governing board and approved, there was no response. When asked if the agency had decided what needed to be monitored and improved for the agency, the response was, "we usually look at our complaint logs, but we have not had any complaints recently." The Administrator was asked what Performance Improvement Project is the agency working on currently? There was no response. At the conclusion of the interview, the Administrator was not able to present evidence or voice a current Performance Improvement Project that the agency had chosen to improve services provided by the agency. The agency failed to develop a Performance Improvement Project to improve services provided by the agency. This finding was reviewed and acknowledged by the Administrator and Director of Nursing during an interview on 3/3/2023 at 2:30 p.m.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to initiate any performance improvement activities within their QAPI program that focused on high risk, high volume, or problem prone areas, resulting in the potential for agency issues with negative consequences for high risk, high volume, or problem prone areas that could affect all patients served by the agency. Findings included: During a review of the Agency's QAPI program, it was noted that the notebook contained no data collections. The Administrator was asked during an interview on 3/3/23 at 1:00 p.m. how and why the agency collects the data for their QAPI program, and if that data could be provided for review. The response was we use patient complaints and chart review, but we have not had any complaints, and we are behind on our chart reviews lately. There was no data to review for the agency QAPI Program, the notebook only contained the Governing Board Policy regarding QAPI.

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 document review and interview, the Agency failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement Program (QAPI), that addressed incidence, prevalence, and severity of problems identified amongst the agency's own patient population as areas of focus to improve patient care, resulting in the potential for rendering substandard care and unmet care needs. Findings included: During an interview with the Administrator regarding the agency QAPI Program on 3/3/23 at 1:00 p.m., Administrator was queried if adverse patient events had been tracked had been tracked and had the agency investigated the causes in order to implement preventive actions for future patients as a part of the agency QAPI program. The response was, "No, but I can always obtain that information on the National Databases." The agency failed to track agency adverse patient events to implement preventative actions as a part of their QAPI Program.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to conduct a performance improvement project for the year 2023. Findings included: During an interview with the Administrator on 3/3/2023 at 1:00 p.m., the administrator was asked what the agency was working on as their performance improvement project for the year 2023? The response was, "our director of nursing is in charge of collecting data for improvement of services. She has an appointment today and won't be here today."

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 document review and interview, the Governing Body (GB) failed to ensure a Performance Improvement Program for quality improvement and patient safety is approved by the Governing Body, defined, implemented, maintained, addresses priorities for improved quality of care, patient safety, and that all improvement actions are evaluated for effectiveness. Findings include: ** Agency Policy: "Governing Body", revised October 2017. The policy states, "The Governing Body (or designated persons so functioning) assumes full legal authority and responsibility for the Agency’s quality assessment and performance improvement program. The Governing Body is responsible for assuring: that an ongoing program for Quality Assessment and Performance Improvement and patient safety is defined, implemented and maintained. That the Agency-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. That clear expectations for patient safety are established, implemented and maintained." Based on documents reviewed and interview, the Governing Body failed to approve a Performance Improvement Program for the year 2023. Findings included: On 3/3/2023 at 1:00 a.m., the Administrator was asked to provide a copy of the Governing Board Meeting Minutes for the years 2023. Upon review of the documents, it was noted that the Governing Board Meeting Minutes failed to have language defining and approving the agency's 2023 Performance Improvement Project. The Governing Board failed to approve a Performance Improvement Project for the year 2023 as required.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to establish and maintain an agency wide infection control program and policy for the surveillance, identification, prevention, and control of COVID-19 that included a vaccine protocol, written policies and procedures that included implementation of additional precautions to mitigate the transmission and spread of Covid-19 (refer to G-684) and failed to develop a policy or process for tracking/documenting information provided by staff who have requested/been granted an exemption from the Covid-19 requirements or Contingency plans for staff who are not fully vaccinated for Covid-19; and failed to ensure that all staff who were granted clinical privileges were vaccinated prior to the provision of care (refer to G 687) resulting in the potential for the development and spread of the Covid-19 virus to staff and all 10 patients currently serviced by this Agency . Findings included: The cumulative effects of these systemic problems resulted in the agency's inability to ensure the provision of safe health care for the condition of participation of 42 CFR§484.70 Infection Prevention and Control.

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 record review and interview, the agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases, including COVID-19, as a part of the agency's Quality Assessment Performance Improvement program, resulting in the potential spread of infections between the agency's 6 patient care staff, and the agency's 10 active patients. Findings included: On 3/3/23 at 10:00 a.m., the agency's Quality Assessment Performance Improvement (QAPI) documentation was reviewed. The Administrator was asked to Provide the policy for COVID-19. The Administrator stated they did not have a policy for COVID-19. When queried to review an infection tracking binder, The Administrator (Adm#1) replied, "We have not yet kept track of staff and patient illnesses." The agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases, including COVID-19.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure to document and track the COVID-19 vaccination completion, exemption, or temporary delay status for 3 of 6 staff employed by the agency. This has the potential to negatively affect the health and well-being of the agency's 10 current patients. Findings include: During a Home Health Survey on 3/3/2023, the Administrator requested to provide 6 employee records for review. A review of the records revealed that only 3 of the 6 employees had COVID-19 vaccination records. There was no further documentation provided that confirmed the 3 employees who had not completed the COVID-19 vaccinations had exemptions. This finding was reviewed and confirmed by the Administrator and Director of Nursing on 3/3/23 at 2:30 p.m.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, it was determined that the Agency failed to ensure the Registered Nurse performed re-assessments of the patient's health status and needs in 1 (MR #2) record of a patient with a diagnosis of congestive heart failure, from a total of 7 sampled records reviewed, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes. Findings included: MR #2: The patient's SOC was 1/26/23 with diagnoses that included Multiple Sclerosis, Congestive Heart Failure and Diabetes Mellitus. During the record review on 3/1/23 at 10:15 a.m., it was noted that the POC ordered SN, PT, OT and HHa services to be provided. Per hospital documents dated 1/10/23, "She had recent hospital stay and diagnosed with new onset Congestive Heart Failure. Her hospital stay was from 12/30/22 - 1/3/23." Section M1060 of the Initial Comprehensive Assessment dated 1/26/23 documented a weight of 180 ponds. It was not indicated if this was an actual or reported weight. There was no baseline assessment of edema and no baseline blood sugar documented in the assessment. On 3/1/23 at 11:30 a.m., a joint home visit was conducted with the Alternate Clinical Manager (CM #2). During the visit, CM #2 failed to assess the patient's weight. Additionally, the patient was noted to have left ankle edema. CM #2 observed and assessed the area of swelling by way of touch and reported, "Yea. It's puffy." CM #2 failed to measure the patient's left ankle edema. CM #2 failed to perform the required assessments of the patient's health status. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/1/23 at 3:31 p.m. CM #2 was present during the exit conference at which time she acknowledged the above findings.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to ensure Occupational Therapy and Physical Therapy services were provided as ordered for 3 (MR's #1, 2, 3) patients who required Therapy services ordered, from a total of 7 sampled records reviewed, resulting in the potential for decline in physical functioning, and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 11/26/22 with diagnoses that included Hypertensive Heart Disease. During the clinical record review on 2/28/23 at 2:45 p.m., it was noted that the plan of care (POC) ordered Occupational Therapy (OT), Skilled Nursing (SN), Physical Therapy (PT) and Home Health Aide (HHa) services to be provided. It was further noted that the patient was discharged from the Agency's services on 12/10/22. At the time of this record review, no Occupational Therapy or Physical Therapy services had been provided as ordered by the Physician. There was no documented evidence of the patient's refusal of services or that the Physician had been informed that services had not been provided as ordered. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/1/23 at 3:13 p.m. MR #2: The patient's SOC was 1/26/23 with diagnoses that included Multiple Sclerosis, Congestive Heart Failure and Diabetes Mellitus. During the record review on 3/1/23 at 10:15 a.m., it was noted that the POC ordered SN, PT, OT and HHa services to be provided. At the time of this review, no OT services had been provided. Additionally, there was no documented evidence of the patient's refusal of services or that the Physician had been informed that services had not been provided as ordered. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/1/23 at 3:31 p.m. MR #3: The patient's SOC was 2/21/23 with diagnoses that included Hypertension and Diabetes Mellitus. During the clinical record review on 3/2/23 at 1:55 p.m., it was noted that the POC ordered SN, PT and OT services to be provided. At the time of this review, no OT services had been provided. Additionally, there was no documented evidence of the patient's refusal of services or that the Physician had been informed that services had not been provided as ordered. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/3/23 at 10:05 a.m.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the clinical record was completed and included detailed Skilled Nursing and Physical Therapy notes for 2 (MR' #2, 3) records with the ordered services, from a total of 7 sampled records reviewed, resulting in the potential for undocumented, unidentified health concerns, and unmet patient needs. Findings include: MR #2: The patient's start of care (SOC) was 1/26/23 with diagnoses that included Multiple Sclerosis, Congestive Heart Failure and diabetes Mellitus. The plan of care (POC) ordered Physical Therapy (PT) services to be provided at a frequency of 2x/wk. x 5 wks. Review of the clinical record on 3/1/23 at 10:15 a.m., revealed that the PT saw the patient on 2/23/23. Further review revealed the PT visit note was blank. During the Entrance Conference on 2/28/23 at 12:20 p.m., the Administrator (Adm #1) was queried regarding the time allowed to submit visit notes and replied, "Forty-Eight hours for everything. Forty-Eight to Seventy-Two, they (disciplines) have to finish." By the end of the survey on 3/3/23, the PT note remained blank. These findings were reviewed with and acknowledged by Adm #1 and the Clinical Manager (CM #1) during an interview on 3/1/23 at 3:31 p.m. MR #3: The patient's SOC was 2/21/23 with diagnoses that included Hypertension and Diabetes Mellitus. The POC ordered SN and PT services to be provided. During the record review on 3/2/23 at 1:55 p.m., it was noted that during a SN home visit, the patient experienced elevated blood pressure readings. The SN initiated measures to have the patient sent to Urgent Care or the Hospital (no clear documentation). There was no further documentation regarding the status of the patient. It was unclear if the patient was admitted to the hospital or returned home after treatment. These findings were reviewed with and acknowledged by Adm #1, CM #1 and the Alternate Clinical Manager (CM #2) who was present during the interview. CM #2 was the nurse in question and stated, "Oh she (patient) wasn't admitted, but I should have documented that." Additionally, the Physical Therapist conducted the Initial Evaluation on 2/27/23, however the visit note/Evaluation remained blank by the end of the survey. The Agency failed to ensure the clinical record was completed and included detailed visit notes. all findings were acknowledged during the above interview.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that the individuals who furnished Home Health Aide services on its behalf, met the competency evaluation requirements of this section by ensuring the subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section were evaluated by a Registered Nurse who observed the Aide's performance of the required tasks with a patient in 1 of 1 Home Health Aide personnel record reviewed, resulting in the potential for the provision of substandard care and unmet care needs Findings include: HHa #1: Date of Hire was 8/2016. The "Initial Competency Assessment Skills Checklist - Home Health Aide/CNA" dated 8/8/16 in HHa #1's personnel file revealed topics: Bed bath, shower/tub bath, nail care, skin care, oral care, shampoo, toileting/elimination, transfer techniques bed to chair, chair to standing assist with ambulation were all documented as "Self-Assessment" as reported by the Home Health Aide. There was no clear evidence that any of the above tasks were directly observed by a Registered Nurse and on an actual or pseudo patient. The column "Evaluation Method" had the letter "V" next to all the above tasks. According to the Biller (OS #1) "The nurses use O for observation and V if it was a verbal discussion. As per this requirement, the above tasks must be directly observed by a Registered Nurse on an actual or pseudo patient. There was no evidence that HHa #1 was deemed competent prior to the provision of care. Additionally, a Competency Self-Assessment Evaluation dated 8/12/19 was signed off by the Clinical Manager. The column titled Evaluation Method was left blank. Additionally, there were no dates on the form that indicated when the tasks were performed or observed. Neither of the above document included the requirement for the Aide to be deemed competent in performing a Sponge, tub, and shower bath. These finding were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 3/2/23 at 1:05 p.m.

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 observation, record review and interview, the Administrator failed to the Clinical Manager was available during all operating hours (G950); failed to ensure a qualified alternate Administrator, was authorized in writing by the Administrator and the governing body, to function in the Administrator's absence (G954); the Clinical Manager failed to ensure that appropriate disciplines were assigned to provide needed care and services for 3 (MR's #1, 2, 3) patients who required skilled services, from a total of 7 sampled records reviewed, resulting in patients not receiving care in accordance with their identified needs (G960); the Clinical Manager failed to ensure the patient's needs were continually assessed for 1 (MR #2) of 1 patient observed during a home visit, who required skilled services and ongoing assessments, from a total 7 sampled records reviewed, resulting in lack of assurance that assessments are performed in accordance with the patient's needs and the potential for physical decline (G966). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation of 42 CFR§484.105 Organization and Administration of Services.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on observation and interview, it was determined the Administrator failed to ensure the Clinical Manager was available at all times during operating hours, resulting in the lack of clinical supervision and oversight and the potential for unmet care needs for the Agency's existing patients. Findings include: On 2/28/23 at 12:20 p.m., during the Entrance conference, the Administrator (Adm #1) gave the name of the Agency's Clinical Manager (CM #1). Throughout the day, Adm #1 was queried as to the whereabouts of CM #1 to which he responded, "I tried calling her but she hasn't returned my calls. I don't know where she is. She has a lot going on." CM #1 was not present and could not be reached during business hours on 2/28/23. On 3/1/23 CM #1 arrived at the Agency, however, acknowledged no awareness of the current patients. On 3/2/23 at 9:00 a.m., upon arrival to the Agency, CM #1 was not present. Adm #1 was asked if CM #1 would be available for interviews during the survey, and reported, "She'll be in." Throughout the day, Adm #1 repeatedly approached this writer and stated, "I've been calling her (CM #1) but she's not answering." At 12:30 p.m., Adm #1 reported, "I've been calling her (CM #1) but she still isn't answering or returning any of my calls." I don't know where she is." CM #1 was not present, nor available during all hours of operation. Adm #1 further stated, "Well I have (name of nurse) who acts as the Alternate Clinical Manager (CM #2)." When queried as to CM #2 whereabouts, Adm #1 reported, "I'm not sure. She could be seeing patients. I'm not sure because she works somewhere else as too." On 3/3/23, CM #1 was present, however, was unable to contribute to the survey process as she acknowledged not being aware of the patients. The Agency failed to ensure that all patient care was under the supervision of a Clinical Manager who was available during all hours of operation.

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 interview, the Agency failed to ensure a qualified alternate, was authorized in writing by the Administrator and the governing body, to function in the Administrator's absence, resulting in the potential for uncoordinated Agency functions. Findings include: On 3/2/23, the Administrator (Adm #1) was asked to provide documented evidence of the Governing board's appointment of an Alternate Administrator. Adm #1 presented a letter that documented, "The Governing Body Board Elect (Administrator's Name) is the administrator." [sic] There was no evidence provided that delegated an Alternate Administrator in the absence of the Administrator. These findings were reviewed and and acknowledged by Adm #1 at the time of discovery.

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record review and interview, the Clinical Manager failed to ensure that appropriate disciplines were assigned to provide needed care and services for 3 (MR's #1, 2, 3) patients who required skilled services, from a total of 7 sampled records reviewed, resulting in patients not receiving care in accordance with their identified needs. Findings include: MR #1: The patient's start of care (SOC) was 11/26/22 with diagnoses that included Hypertensive Heart Disease. During the clinical record review on 2/28/23 at 2:45 p.m., it was noted that the plan of care (POC) ordered Occupational Therapy (OT), Skilled Nursing (SN), Physical Therapy (PT) and Home Health Aide (HHa) services to be provided. It was further noted that the patient was discharged from the Agency's services on 12/10/22. At the time of this record review, no Occupational Therapy or Physical Therapy services had been provided as ordered by the Physician. There was no indication that the Clinical Manager (CM #1) provided oversight to ensure the ordered disciplines were assigned to ensure care and services were provided in accordance with the Physician's orders. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and CM #1 during an interview on 3/1/23 at 3:13 p.m., to which CM #1 acknowledged not being aware of the patient's needs. "If the QA (Quality Assurance) nurse tells me about a problem, that's how I become aware." MR #2: The patient's SOC was 1/26/23 with diagnoses that included Multiple Sclerosis, Congestive Heart Failure and Diabetes Mellitus. During the record review on 3/1/23 at 10:15 a.m., it was noted that the POC ordered SN, PT, OT and HHa services to be provided. There was no indication that CM #1 provided oversight to ensure the ordered disciplines were assigned to ensure care and services were provided in accordance with the Physician's orders. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 3/1/23 at 3:13 p.m. MR #3: The patient's SOC was 2/21/23 with diagnoses that included Hypertension and Diabetes Mellitus. During the clinical record review on 3/2/23 at 1:55 p.m., it was noted that the POC ordered SN, PT and OT services to be provided. At the time of this review, no OT services had been provided. There was no indication that CM #1 provided oversight to ensure the ordered disciplines were assigned to ensure care and services were provided in accordance with the Physician's orders. These findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 3/1/23 at 3:13 p.m.

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on observation, record review and interview, it was determined that the Clinical Manager failed to ensure the patient's needs were continually assessed for 1 (MR #2) of 1 patient observed during a home visit, who required skilled services and ongoing assessments, from a total 7 sampled records reviewed, resulting in lack of assurance that assessments are performed in accordance with the patient's needs and the potential for physical decline. Findings include: MR #2: The patient's SOC was 1/26/23 with diagnoses that included Multiple Sclerosis, Congestive Heart Failure and Diabetes Mellitus. During the record review on 3/1/23 at 10:15 a.m., it was noted that the POC ordered SN, PT, OT and HHa services to be provided. Per hospital documents dated 1/10/23, "She had recent hospital stay and diagnosed with new onset Congestive Heart Failure. Her hospital stay was from 12/30/22 - 1/3/23." Section M1060 of the Initial Comprehensive Assessment dated 1/26/23 documented a weight of 180 ponds. It was not indicated if this was an actual or reported weight. There was no baseline assessment of edema and no baseline blood sugar documented in the assessment. On 3/1/23 at 11:30 a.m., a joint home visit was conducted with the Alternate Clinical Manager (CM #2). During the visit, CM #2 failed to assess the patient's weight. Additionally, the patient was noted to have left ankle edema. CM #2 observed and assessed the area of swelling by way of touch and reported, "Yea. It's puffy." CM #2 failed to measure the patient's left ankle edema. CM #2 failed to perform the required assessments of the patient's health status. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 3/1/23 at 3:31 p.m. CM #2 was present during the exit conference at which time she acknowledged the above findings. During the interview, CM #1 was queried about her involvement in the patient's overall care planning and knowledge of the patient's needs and reported, "I only know about the patient's I have. If there is a problem, the QA (Quality Assurance) nurse will let me know and I'll take care of if." When asked of QA #1's whereabouts, the biller (OS #1) reported, "She's in the Philippines. She's been there since January." The Clinical Manager (CM #1) failed to ensure the patient's and their needs were continually assessed.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to include required information in the Transfer and Discharge Summaries in 1 of 1 (MR# 7) Transfer records and 1 of 2 (MR#6) Discharge records reviewed resulting in a lack of information to ensure continuity of care for the patients transferred from the agency. Findings include: **Agency Policy: "Transfer/Referral Criteria", revised October 2017. The policy states, "The transfer summary will be provided within two business days of a planned transfer...includes a summary of care/services provided and the reasons for transfer." **Agency Policy: "Discharge Criteria", revised October 2017. The policy states, "Patient will be discharged from services as follows: "Patient refuses services or elects to be discharged." MR#6: The Start of Care (SOC) was dated 1/5/2023. The Plan of Care (POC) for the certification period 1/5/23 to 3/5/23 identified diagnoses of Primary osteoarthritis, Pain in right knee, Hypertension (HTN), Hypocalcemia, Chronic Kidney Disease (CKD), and Concussion with Loss of Consciousness (LOC). The POC included orders for Skilled Nursing (SN) and Physical Therapy (PT) services. Upon review of the record, a physician order dated 1/9/23 included this statement "patient refused physical therapy services". The record also included a Discharge Summary dated 1/10/23 completed by the SN. Review of the SN DC Summary was completely blank except for the "Effective Date" resulting in no documented information regarding the care provided to the patient by the agency. In addition, there was no information found in the record that indicated the physician had been notified of the patient's discharge from the agency. MR#7: The Start of Care (SOC) was dated 1/19/2023. The Plan of Care (POC) for the certification period 1/19/2023 to 3/19/2023 identified diagnoses of Diabetes Type 2 (DM2), Hypertension (HTN), Chronic Obstructive Pulmonary Disease (COPD), Abnormality of gait, post-Covid-19 Condition, and Long-term use of Insulin. The patient was transferred to a hospital on 2/8/23 by the family due to patient demonstrating shallow breathing and elevated blood sugar. However, upon review of the transfer summary, there was no documentation that stated the name of the facility to which the patient was transferred. Also, there was no evidence or documentation that the patient's current reconciled Medication list was transmitted to the subsequent provider. The Transfer Summary documented (skip answer). In addition, there was no documented evidence that the physician had been notified of the transfer. These findings were reviewed and acknowledged during an interview with the Administrator and Clinical Manager on March 3, 2023, at 2:30 p.m.