Every finding on record at Arbor Woods Home Health Care, Inc

A Medicare Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on 10/17/22 through 10/20/22 at: Legacy Home Healthcare 1615 W Centre Ave., Suite 201 Portage, MI 49024 At the time of the survey, the Agency did not operate any branch offices. At the survey's conclusion, the Agency was found to be out of compliance at the standard level, with the requirements for participation at 42 CFR §484.102, Emergency Preparedness.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop and maintain an emergency preparedness plan centered on both agency-based and community-based risk assessments, resulting in a lack of direction and duties for Agency personnel in the event of an actual disaster. This deficient practice has the potential to negatively affect the health and safety of the Agency's current 37 patients. Findings include: On 10/19/22, the Agency's Emergency Preparedness (EP) information was requested. The Agency provided documentation for review that included the Agency's EP plan, policies, and procedures. However, no documentation was found that indicated the Agency had performed an All-Hazards Risk Assessment. There is no documentation of an agency-based or community-based risk assessment which is required in the development of the Agency's emergency plan. During an interview on 10/20/22 at 11:20 AM., the Administrator reviewed and acknowledged the above findings.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on document review and interview, the Agency failed to conduct exercises that are community-based to test its Emergency Preparedness (EP) program; and failed to provide documentation of any community-based drills, tabletop exercises and emergency events, resulting in the Agency's inability to ensure staff actions align with community-based expectations in the event of an actual emergency. This deficient practice has the potential to negatively affect the health and safety of the agency's current 37 patients. Findings include: On 10/19/22, the Agency's EP documentation was reviewed. During the review, it was noted that the Agency had performed facility-based exercises to test its EP program. However, no evidence was found that indicated any involvement or participation in the full-scale community-based exercise which is required every 2 years. When the Administrator (Adm#1) was queried concerning the above finding, Adm#1 replied, "I didn't know about the community-based drills." During an interview on 10/20/22 at 11:05 AM., Adm#1 and the Director of Nursing acknowledged the above findings.

The following Condition and Standard level deficiencies were identified during a Medicare authorized recertification survey, concurrent with the Vaccine Mandate protocol survey, conducted by the Michigan Department of Licensing and Regulatory Affairs on 10/17/22 through 10/20/22 at: Legacy Home Healthcare1615 W Centre Ave., Suite 201Portage, MI 49024 Services offered at the time of survey: Skilled Nursing, Physical Therapy, Occupational Therapy, Speech Therapy, and Home Health Aide. The Agency did not operate any additional branch site locations. Clinical records reviewed for this survey: 3 records with home visits and 4 records without home visits, for a total of 7 records reviewed. At the conclusion of the survey, the Agency was determined to be out of compliance with the following Conditions of Participation: 42 CFR §484.75 Skilled Professional Services. As a result of the Condition level noncompliance, the Agency is prohibited for 2 years 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 record review and interview, the agency failed to ensure that 1 (MR's #1) of 7 records reviewed were included in their overall planning of care including informing the patient/caregiver in advance of which services would be provided and disciplines that will furnish care, resulting in a lack of inclusion in planning, lack of informed consent and unmet care needs. Findings include: MR#1: The Start of Care (SOC) was dated 10/6/22. The Plan of Care (POC) identified diagnoses of Cellulitis, Diabetes Type 2 and Lower Bilateral Wounds. During record review on 10/18/22, it was noted that a Skilled Nursing (SN) Comprehensive Assessment dated 10/6/22 documented, “Dr agreeable with POC and orders obtained for MSW (Medical Social Worker) and aide.” There was no documentation that the patient received MSW services. The EMR (Electronic Medical Record) showed a visit scheduled on 10/10/22 by the MSW that was never completed. The agency failed to provide MSW services as ordered. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Compliance Manager (QA#1) during an interview on 10/20/22 at 11:35 am.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD 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 7 of 7 records reviewed (MR#s 1, 2, 3, 4, 5, 6, 7), from a total of 7 records reviewed, resulting in incomplete clinical information to aide in determining the needs of the patient. Findings included: MR#1: The Start of Care (SOC) was dated 10/6/22. The Plan of Care (POC) identified diagnoses of Cellulitis, Diabetes Type 2 and Lower Bilateral Wounds. During record review on 10/18/22, it was noted that the SOC comprehensive assessment dated 10/6/22, documented under "Primary Diagnosis and Other Diagnoses", all 14 diagnoses had an onset date of 10/6/22. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#2: The Start of Care (SOC) was dated 4/6/22. The Plan of Care (POC) identified diagnoses of Tendinitis of Left Rotator Cuff, Left Knee Pain and Weakness. During record review on 10/18/22, it was noted that the recertification comprehensive assessment dated 8/2/22, documented under "Primary Diagnosis and Other Diagnoses", all 8 diagnoses had an onset date of 8/2/22. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR#3: The Start of Care (SOC) was dated 6/24/22. The Plan of Care (POC) identified diagnoses of Lymphedema, Venous Insufficiency and Congestive Heart Failure. During record review on 10/19/22, it was noted that the SOC comprehensive assessment dated 6/24/22, documented under "Primary Diagnosis and Other Diagnoses", all 16 diagnoses had an exacerbation date of 10/6/22. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Compliance Manager (QA#1) during an interview on 10/20/22 at 11:30 am. MR #4: The start of care (SOC) date was 7/12/2022, with diagnoses which included cellulitis of abdominal wall, hypertensive chronic kidney disease, diabetes-type 2, and dependence on supplemental oxygen. During record review on 10/18/22, it was noted the SOC comprehensive assessment performed by Skilled Nursing (dated 7/12/22), documented under "Primary Diagnosis and Other Diagnoses", that 11 of 11 diagnoses had an "Onset" date of 7/12/22. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. In addition, under "Cardiovascular Status", skilled nursing had left the entire cardiac assessment blank. MR #5: The SOC date was 4/11/2022, with diagnoses that included chronic obstructive pulmonary disease, acute and chronic respiratory failure with hypoxia, pneumonia, and hypertension. During record review on 10/18/22, it was noted that the SOC comprehensive assessment performed by Physical Therapy (dated 4/11/22), documented under "Primary Diagnosis and Other Diagnoses", that 17 of 17 diagnoses had an onset date of 4/11/22. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. MR #6: The SOC date was 4/2/2022, with diagnoses that included hypertensive heart disease, congestive heart failure, and dysphagia (difficulty swallowing). During record review on 10/19/22, it was noted that the SOC comprehensive assessment performed by Speech Therapy (dated 4/2/22), documented under "Primary Diagnosis and Other Diagnoses", that 16 of 16 diagnoses had an onset date of 3/31/22. No exacerbation, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. In addition, under "Cardiovascular Status", Speech Therapy had left the entire cardiac assessment blank. MR #7: The SOC date was 8/29/2022, with diagnoses that included indwelling urinary catheter, heart disease, and ataxia (lack of muscle coordination). During record review on 10/19/22, it was noted that the SOC comprehensive assessment dated 8/29/22, documented under "Primary Diagnosis and Other Diagnoses", that 15 of 15 diagnoses had an exacerbation date of 8/25/22. No onset, prior treatments, outcomes, or history of how these diagnoses led to the need for home care were documented. These findings were reviewed with and acknowledged by the Administrator and Compliance Manager during an interview on 10/20/22 at 11:23 AM.

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 document review and interview, it was determined the Agency failed to ensure the start of care (SOC) comprehensive assessment included a comprehensive review of all medications to determine any adverse effects which included physician notification in 5 (MR's #1, 3, 5, 6, 7) of 7 total sample records reviewed; and failed ensure a Registered Nurse (RN) reviewed all medications in 2 (MR's # 5, 6) of 2 records reviewed with therapy only assigned cases from a total of 7 records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency. Findings include: Agency Policy: "Initial Assessments/Comprehensive Assessments/Follow Up Visits" 9.6.1 (Revised March 2018) stated, "Drug Regimen Review: Each patient's comprehensive assessment includes a review of all drugs the patient is currently taking... Significant side effects; Significant drug interactions; Duplicate therapy; Potential adverse effects; Significant medication issues..." No policy was made available upon request that noted a Registered Nurse (RN) must perform a subsequent review of medications in therapy only cases. Agency Policy: "Medication Administration" 8.7.1 (Revised March 2018) stated, "Agency staff will check all patient medications to identify possible ineffective drug therapy or adverse reactions... and report any problems to the physician." MR #5: The start of care (SOC) date was 4/11/2022, with diagnoses that included chronic obstructive pulmonary disease, pneumonia, and hypertension. On 10/18/22, review of the SOC comprehensive assessment (dated 4/11/22), noted the patient's medication review was performed by PT#1 (Physical Therapist), which was the only discipline assigned to the case other than Occupational Therapy. No evidence of a subsequent review of the patient's medications by a RN was found in the medical record. Further, PT#1 documented under section M2001 of the Initial Comprehensive Assessment, "Issues found during review." The Agency's own drug review software revealed 3 major interactions with no identified duplicative drug therapies. However, when the patient's 23 prescribed medications at the SOC were entered into "Drugs.com" (on-line pharmaceutical reference for healthcare professionals), the following was revealed: 2 Major drug to drug interactions and 7 duplicative drug therapies. Further review noted section M2003 "Medication Follow-up" was left blank. No documentation was found in the medical record that indicated the physician was notified of the above potential adverse effects/duplicative drug therapies as stipulated by the Agency's policies above. During an interview on 10/20/22 at 10:25 AM., the Administrator and Director of Nursing had confirmed and acknowledged the above findings. MR #6: The SOC date was 4/2/2022, with diagnoses that included hypertensive heart disease, congestive heart failure, and dysphagia (difficulty swallowing). On 10/19/22, review of the SOC comprehensive assessment (dated 4/2/22), noted the patient's medication review was performed by ST#1 (Speech Therapist). The disciplines assigned to the case other than ST were Physical Therapy and Occupational Therapy. No evidence of a subsequent review of the patient's medications by a RN was found in the medical record. Further, ST#1 documented under section M2001 of the Initial Comprehensive Assessment, "No issues found during review." However, when the patient's 13 prescribed medications at the SOC were entered into "Drugs.com", the following was revealed: 1 Major drug to drug interaction and 1 duplicative drug therapy. ST#1 documented "Skip Answer." concerning section M2003 "Medication Follow-up". Subsequently, no documentation was found in the medical record that indicated the physician was notified of the above potential adverse effects/duplicative drug therapy as stipulated by the Agency's policies above. During an interview on 10/20/22 at 10:45 AM., the Administrator and Director of Nursing had confirmed and acknowledged the above findings. MR #7: The SOC date was 8/29/2022, with diagnoses that included indwelling urinary catheter, heart disease, and ataxia (lack of muscle coordination). On 10/19/22, review of the SOC comprehensive assessment (dated 8/29/22), noted the patient's medication review was performed by an RN#1. RN#1 documented under section M2001 of the Initial Comprehensive Assessment, "Yes - Issues found during review." The Agency's own drug review software revealed 13 major interactions with no identified duplicative drug therapies. However, when the patient's 33 prescribed medications at the SOC were entered into "Drugs.com" (on-line pharmaceutical reference for healthcare professionals), the following was revealed: 7 Major drug to drug interactions and 9 duplicative drug therapies. Further review noted section M2003 "Medication Follow-up" was left blank. No documentation was found in the medical record that indicated the physician was notified of the above potential adverse effects/duplicative drug therapies as stipulated by the Agency's policies above. During an interview on 10/20/22 at 11:10 AM., the Administrator and Director of Nursing had confirmed and acknowledged the above findings. MR#1: The Start of Care (SOC) was dated 10/6/22. The Plan of Care (POC) identified diagnoses of Cellulitis, Diabetes Type 2 and Lower Bilateral Wounds. During record review on 10/18/22, a medication interactions report was completed in the EMR (Electronic Medical Record) and noted 7 major medication interactions between: Amlodipine and Simvastatin, Amlodipine and Xanax, Aripiprazole and Duloxetine, Aripiprazole and Cinacalcet, Lactulose and MiraLax, Oxycodone and Xanax, Stool softener plus Lax and MiraLax. There were no duplicate medications listed. The Skilled Nurse (SN) documented under M2001 Drug Regimen Review of the comprehensive assessment, “Yes - Issues found during review." M2003 Medication Follow-up stated, “Notified Dr. of no Simvastatin or Vitamin D in home.” Additionally, the patient’s 32 prescribed medications were entered into "Drugs.com" (on-line pharmaceutical reference for healthcare professionals), which revealed 5 duplicate medications that were not reported on the medication profile. No documentation was found in the medical record that indicated the physician was notified of the above potential adverse effects/duplicative drug therapies as stipulated by the Agency's policy. MR#3: The Start of Care (SOC) was dated 6/24/22. The Plan of Care (POC) identified diagnoses of Lymphedema, Venous Insufficiency and Congestive Heart Failure. During record review on 10/19/22, a medication interactions report was completed in the EMR and noted 2 major medication interactions between: Cardizem and Metoprolol, Norco and Flexeril. There were no duplicate medications listed. The SN documented under M2001 Drug Regimen Review of the comprehensive assessment, “No - No issues found during review." Thus, M2003 Medication Follow-up was blank due to the “No” answer to M2001. Additionally, the patient’s 16 prescribed medications were entered into "Drugs.com" (on-line pharmaceutical reference for healthcare professionals), which revealed 2 duplicate medications that were not reported on the medication profile. No documentation was found in the medical record that indicated the physician was notified of the above potential adverse effects/duplicative drug therapies as stipulated by the Agency's policy. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Compliance Manager (QA#1) during an interview on 10/20/22 at 12:10 pm.

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, it was determined the Agency failed to ensure the goals on the Plan of Care (POC) were measurable in 5 (MR#'s 1, 2, 3, 4, 7) of 7 records reviewed out of a total sample of 7 records; and failed to include pertinent safety measures/education to protect patient/others from injury in 1 (MR#7) of 1 record reviewed with supplemental oxygen with an active smoking status, from a total sample of 7 records reviewed, resulting in a potential for unmet patient care needs and significant injury. Findings include: MR#1: The Start of Care (SOC) was dated 10/6/22. The Plan of Care (POC) identified diagnoses of Cellulitis, Diabetes Type 2 and Lower Bilateral Wounds. During record review on 10/18/22, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Verbalizes understanding of disease process, signs and symptoms and measures to prevent exacerbation. Adheres to medication and treatment regime. Verbalizes and demonstrates understanding of medication regimen, including safety and effectiveness. Demonstrates understanding of diet where deficit.” Additionally, another goal stated, “Vital signs will be within normal limits for patient. Demonstrates appropriate pain management coping mechanisms. Pain will be at an acceptable level for patient.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR#2: The Start of Care (SOC) was dated 4/6/22. The Plan of Care (POC) identified diagnoses of Tendinitis of Left Rotator Cuff, Left Knee Pain and Weakness. During record review on 10/18/22, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Patient/Caregiver will demonstrate knowledge of medication and diet by 05/31/2022, Patient/Caregiver demonstrates correct use of medication by 04/13/2022.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR#3: The Start of Care (SOC) was dated 6/24/22. The Plan of Care (POC) identified diagnoses of Lymphedema, Venous Insufficiency and Congestive Heart Failure. During record review on 10/19/22, it was noted that the goals within the POC were not measurable. For example, one goal stated, “Verbalizes understanding of disease process, signs and symptoms and measures to prevent exacerbation. Adheres to medication and treatment regime. Verbalizes and demonstrates understanding of medication regimen, including safety and effectiveness. Demonstrates understanding of diet where deficit.” Additionally, another goal stated, “Vital signs will be within normal limits for patient. Demonstrates appropriate pain management coping mechanisms. Pain will be at an acceptable level for patient.” There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Compliance Manager (QA#1) during an interview on 10/20/22 at 11:55 am. MR #4: The start of care (SOC) date was 7/12/2022, with diagnoses which included cellulitis of abdominal wall, hypertensive chronic kidney disease, diabetes-type 2, and dependence on supplemental oxygen. Review of the plan of care (POC) noted 14 of 14 skilled nursing goals were not written in measurable terms to objectively ascertain progress toward patient specific goals. Examples include: "Adheres to medication and treatment regime; Vital signs will be within normal limits for patient; Demonstrates proper foot care; Verbalizes understanding of home safety, emergency procedures, and infection control measures." There was no evidence of how these goals could be objectively measured to ascertain the patient's progress or lack of towards patient care goals. MR #7: The SOC date was 8/29/2022, with diagnoses that included indwelling urinary catheter, heart disease, ataxia (lack of muscle coordination). On 10/19/22, review of hospital records found within the referral for homecare noted the following information: Hospital discharge date of 8/24/22, noted a negative respiratory assessment and blood oxygen levels normal at 96% on room air. The POC ordered Physical Therapy (PT) to evaluate the patient and follow-up with a visit frequency of twice a week times four weeks. On 8/31/22, PT evaluated the patient and documented under "End of visit/post-exercise" an oxygen level of 98% on room air. The next PT visit note on 9/6/22 documented a pre-exercise oxygen level of 82% on room air. This note under "Comments" documented "Low SPo2 (oxygen level) at start of session as pt. (patient) had walked away from building on her own to smoke and was found very SOB (short of breath) and tired. SPo2 returned to normal after 5-6 min. of rest and deep breathing. Pt states she is very upset this morning about missing some personal items for her apartment and decided that she was going to start smoking again." After the 9/6/22 PT visit, it was noted that 6 of 7 visits from 9/8/22 through 9/28/22 documented the patient's oxygen level was low enough to require physician notification (less than 92% at rest /with exertion.) Supplemental oxygen was documented as being delivered on 9/28/22 per PT visit note. However, no documentation was evidenced that indicated the patient had stopped smoking. Review of the medical record found no evidence in the patient's POC of educating or warning the patient concerning the dangers of combining oxygen and smoking through survey exit on 10/20/22. In addition, 8 of 8 skilled nursing goals were not written in measurable terms to objectively ascertain progress toward patient specific goals. Examples include: "Patient/Caregiver cardiac/respiratory status will remain stable by 9/12/2022; Patient/Caregiver verbalize measures to protect skin integrity by 9/12/22; Patient/Caregiver will demonstrate knowledge of medication and diet by 9/19/2022. The findings above were reviewed with and acknowledged by the Administrator (Adm.#1) and Compliance Manager (QA#1) during an interview on 10/20/22 at 11:15 AM. Both agreed the POC goals could not be objectively measured to ascertain the patient's progress towards optimal clinical outcomes.

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 establish Vaccine protocol written policies and procedures that included (iv) a process for tracking and securely documenting the COVID-19 vaccination status of all staff, resulting in the potential for the development and spread of the COVID-19 virus to staff and all patients serviced by this Agency. Findings include: On 10/20/22, upon review of the Agency’s Vaccine policy, it was noted that requirements had not been met. The staff list containing the vaccination status of each employee had a check mark for those who have been vaccinated or “exemption” noted for those unvaccinated. There was no documentation of what vaccine was received and or if a booster had been administered. These findings were discussed with and acknowledged by the Administrator (Adm.#1) during an interview on 10/20/22.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to ensure the Physical Therapist (PT) followed accepted standards of practice in assuming responsibility for the care of 1 (MR #7) of 1 record with supplemental oxygen use concurrent with an active smoking status and diabetic needs (See G704); failed to provide education/safety instructions in 1 (MR# 7) of 1 patient on oxygen with nicotine dependence (See G 714); and failed to ensure the physician was notified of the staff not providing services as ordered in the plan of care and reportable parameters in 2 (MR#s 2 and 3) of 7 records reviewed; and failed to notify the physician concerning low blood oxygen levels in 1 (MR#7) of 1 record reviewed with a significant change in clinical condition (See G718). 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§484.75 Skilled Professional Services.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure Physical Therapy (PT) and Skilled Nursing (SN) met the needs of the patient in 1 (MR #7) of 1 record reviewed with supplemental oxygen concurrent with an active smoking status and diabetic needs, from a total sample of 7 records reviewed, resulting in the potential for physical harm to the patient. Findings included: MR#7: The start of care (SOC) date was 8/29/2022, with diagnoses that included indwelling urinary catheter, heart disease, ataxia (lack of muscle coordination), and supplemental oxygen. On 10/19/22, review of hospital records found within the referral for homecare noted the following information: On 8/24/22, patient was discharged from the hospital after hematuria (blood in urine) and possible UTI (urinary tract infection). Respiratory assessment on 8/24/22 was normal, with blood oxygen levels at 96% (normal) on room air. The plan of care (POC) ordered on 8/29/22 for PT to evaluate the patient and follow-up with a visit frequency of twice a week times four weeks and directed Agency staff to notify the physician when the patient's Spo2 (blood oxygen level) was "less than 92% at rest /with exertion." On 8/31/22, PT evaluated the patient and documented under "End of visit/post-exercise" an oxygen level of 98% on room air. The next PT visit note on 9/6/22 documented a pre-exercise oxygen level of 82% on room air. This note under "Comments" documented, "Low Spo2 at start of session as pt. (patient) had walked away from building on her own to smoke and was found very SOB (shortness of breath) and tired. SPo2 returned to normal after 5-6 min. of rest and deep breathing. Pt states she is very upset this morning about missing some personal items for her apartment and decided that she was going to start smoking again." The following PT visit on 9/8/22 documented the following: "Pt (patient) with initial low Spo2 when sitting on bed (85%). With proper deep breathing, increased to 93%. Pt states she gets periods of SOB at night and often gasps for air." On 9/12/22, the third PT visit documented, "Initial Spo2 at 84% at rest; with ambulation decreased to 81-82% and increased only to 90% with 5 min of rest. Pt SOB with ambulation and exercises... MD notified of concern and possible need for O2 use. Pt states she previously used oxygen at home." Record review revealed this was the first physician notification concerning the significant change in the patient's condition noted on 9/6/22. On 9/15/22, PT documented in the visit note the following: "Pt on room air at start of session at rest with spo2 of 85%. Pt with noticeable SOB with any activity, spo2 decreases to 81-84% with transfers and short distance ambulation... Pt states she is getting very SOB during the night and often wakes up gasping for breath. (Physician's) office called again and reported above. Ashley from (physician's) office will call CareLinc to follow up on oxygen order." In addition, no orders were found in the medical record to supply the patient with oxygen. The first reference to the patient having oxygen is reflected in a PT note on 9/28/22 which documented, "Client now has supplemental O2 and has potential to improve functional independence." Skilled Nursing (SN) was ordered to provide visits once a week times nine weeks. SN documented the patient's oxygen level was 90% at rest on room air during the 9/2/22 and 9/15/22 visits, with no physician notification evidenced. On 9/26/22 visit note, SN documented the patient's Spo2 level was 85% on room air. Under "Respiratory" SN documented the following: "Notified PCP about low oxygen level and need for oxygen at night. Spoke with Ashley who is working with Carelink on this issue." From 9/6/22 through 9/28/22, 8 of 8 PT visits were documented as having "Care Coordination" with SN. No instructions were found in the medical record of either SN or PT services educating and directing the patient to go to the emergency room in the event the patient was gasping for air without supplemental oxygen in hand. In addition, SN and PT services had no documentation that indicated the patient had stopped smoking. Review of the medical record found no evidence of educating or warning the patient concerning the dangers of combining oxygen and smoking through survey exit on 10/20/22. Further review of the record noted hospital documentation found within the referral for home care, which documented the patient had a diagnosis of diabetes mellitus (DM). Under the hospital's "Recent Labs", 6 of 6 recorded blood sugar levels ranging from 149 mg/dL on 8/23/22, to 281 (significantly above normal) mg/dL on 8/24/22 were noted. However, the Initial Comprehensive assessment performed by SN on 8/29/22, documented no blood sugar values (current or recently obtained) in the assessment despite noting the patient was a diabetic. SN was ordered to have a visit frequency of once-a-week times nine weeks. The following dates represent SN home visit documentation concerning the management of the patient's diabetes: 9/2/22 - "Blood Sugar NA (not applicable) Pt is not diabetic or prediabetic." 9/3/22 - "Does not check blood sugar. Taking Jardiance for DM." 9/8/22 - "Not checking blood sugar" 9/15/22 - "Blood Sugar NA, Pt is not diabetic or prediabetic." 9/20/22-"Blood Sugar NA, Pt is not diabetic or prediabetic." 9/26/22-"Blood Sugar NA, Pt is not diabetic or prediabetic." 9/29/22- SN Discharge/Transfer Summary, "Blood Sugar NA, Pt is not diabetic or prediabetic. Staff is not checking her blood sugar. Patient states she is borderline diabetic." No blood sugar readings, interventions, or goals were evidenced in the medical record while under the Agency's care to help optimize the patient's diabetes. The findings above were reviewed with and acknowledged by the Administrator, Director of Nursing, and Compliance Manager (QA#1) during an interview on 10/20/22 at 10:40 AM. All agreed PT and SN should have notified the physician as ordered concerning low oxygen levels and that SN failed to read pertinent, objective information in the home care referral which reflected the patient's diabetic needs and recent severity level.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on document review and interview, the Agency failed to provide education/safety instructions in 1 (MR#7) of 1 patient on oxygen with nicotine dependence; resulting in the potential for unmet patient care needs and a poor clinical outcome. MR#7: The start of care (SOC) date was 8/29/2022, with diagnoses that included indwelling urinary catheter, heart disease, ataxia (lack of muscle coordination), and supplemental oxygen. On 10/19/22, review of the record noted the plan of care (POC) ordered Physical Therapy (PT) on 8/29/22 to evaluate the patient and follow-up with a visit frequency of twice a week times four weeks. On 8/31/22, PT's evaluation documented under "End of visit/post-exercise" an oxygen level of 98% on room air. The next PT visit note on 9/6/22 documented a pre-exercise oxygen level of 82% on room air. This note under "Comments" documented, "Low Spo2 (blood oxygen level) at start of session as pt. (patient) had walked away from building on her own to smoke and was found very SOB (short of breath) and tired. SPo2 returned to normal after 5-6 min. of rest and deep breathing. Pt states she is very upset this morning about missing some personal items for her apartment and decided that she was going to start smoking again." The following PT visit on 9/8/22 documented the following: "Pt (patient) with initial low Spo2 when sitting on bed (85%). With proper deep breathing, increased to 93%. Pt states she gets periods of SOB at night and often gasps for air." On 9/12/22, the third PT visit documented, "Initial Spo2 at 84% at rest; with ambulation decreased to 81-82% and increased only to 90% with 5 min of rest. Pt SOB with ambulation and exercises... MD notified of concern and possible need for O2 use. On 9/15/22, PT documented in the visit note the following: "Pt on room air at start of session at rest with spo2 of 85%. Pt with noticeable SOB with any activity, spo2 decreases to 81-84% with transfers and short distance ambulation... Pt states she is getting very SOB during the night and often wakes up gasping for breath. (Physician's) office called again and reported above. Ashley from (physician's) office will call CareLinc to follow up on oxygen order." The first reference to the patient having oxygen is reflected in a PT note on 9/28/22 which documented, "Client now has supplemental O2 and has potential to improve functional independence." Skilled Nursing (SN) was ordered to provide visits once a week times 9 weeks. SN documented the patient's oxygen level was 90% at rest on room air during the 9/2/22 and 9/15/22 visits, with no physician notification noted. On 9/26/22 visit note, SN documented the patient's Spo2 level was 85% on room air. Under "Respiratory" SN documented the following: "Notified PCP about low oxygen level and need for oxygen at night. Spoke with Ashley who is working with Carelink on this issue." From 9/6/22 through 9/28/22, 8 of 8 PT visits were documented as having "Care Coordination" with SN. No instructions were found in the medical record of either SN or PT services educating and directing the patient to go to the emergency room in the event the patient was gasping for air without supplemental oxygen in hand. In addition, SN and PT services had no documentation that indicated the patient had stopped smoking. Review of the medical record found no evidence in the medical record of educating or warning the patient (no caregiver/additional help noted in the record) concerning the dangers of combining oxygen with smoking, and no goals or interventions were found in the medical record concerning these findings through survey exit on 10/20/22. Further, SN's visit note on 9/29/22 documented under "Respiratory" the patient is using 2 Liters of oxygen at night. No education was found warning the patient of oxygen needs/demands during the daytime when oxygen levels were significantly low with any kind of activity per PT notes. The findings above were reviewed with and acknowledged by the Administrator, Director of Nursing, and Compliance Manager (QA#1) during an interview on 10/20/22 at 10:40 AM.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current 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 the physician was notified of the staff not providing services as ordered in the plan of care and reportable parameters in 2 (MR#s 2 and 3) of 7 records reviewed; and failed to notify the physician concerning low blood oxygen levels in 1 (MR#7) of 1 record reviewed with a significant change in clinical condition, out of a total of 7 records reviewed, resulting in the potential for unmet patient needs and poor patient outcomes to all 37 patients currently serviced by this Agency. Findings include: MR#2: The Start of Care (SOC) was dated 4/6/22. The Plan of Care (POC) identified diagnoses of Tendinitis of Left Rotator Cuff, Left Knee Pain and Weakness. During record review on 10/18/22, it was noted that the POC dated 4/6/22 documented a “Reportable Parameter” of “Pain equal to or above 8/10.” The recertification POC dated 6/5/22 failed to have a “Reportable Parameter” for pain, but stated, “Monitor and assess signs and symptoms of pain and effectiveness of pain control measures every visit. Pain control measures include use of pain medication when needed. Medication effectiveness will be monitored. Education on management of pain will include use of medication to mitigate pain and alternative methods of pain relief. Compliance with pain control measures will be monitored. Physician will be notified if pain relief methods do not offer acceptable level of pain control.” Additionally, the following recertification POC dated 8/4/22 contained no “Reportable Parameter” for pain and stated, “Pain Status: Assess pain.” On 8/29/22 and 9/6/22, the Skilled Nurse (SN) documented a pain level of 10 and failed to notify the physician. The Agency failed to ensure the physician was promptly notified of the patient's elevated pain. MR#3: The Start of Care (SOC) was dated 6/24/22. The Plan of Care (POC) identified diagnoses of Lymphedema, Venous Insufficiency and Congestive Heart Failure. During record review on 10/19/22, it was noted that the SN completed an add on re-evaluation on 9/15/22 due to “SN eval related to open wound to LLE (Left Lower Extremity).” The SN documented a pain level of 10 and failed to notify the physician of the patient’s elevated pain. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Compliance Manager (QA#1) during an interview on 10/20/22 at 12:05 pm. MR#7: The start of care (SOC) date was 8/29/2022, with diagnoses that included indwelling urinary catheter, heart disease, ataxia (lack of muscle coordination), and supplemental oxygen. On 10/19/22, review of hospital records found within the referral for homecare noted the following information: On 8/24/22, patient was discharged from the hospital after hematuria (blood in urine) and possible UTI (urinary tract infection). Respiratory assessment on 8/24/22 was normal, with blood oxygen levels at 96% (normal) on room air. The plan of care (POC) ordered on 8/29/22 for PT to evaluate the patient and follow-up with a visit frequency of twice a week times four weeks and directed Agency staff to notify the physician when the patient's Spo2 was "less than 92% at rest /with exertion." On 8/31/22, PT evaluated the patient and documented under "End of visit/post-exercise" an oxygen level of 98% on room air. The next PT visit note on 9/6/22 documented a pre-exercise oxygen level of 82% on room air. This note under "Comments" documented, "Low Spo2 (blood oxygen level) at start of session as pt. (patient) had walked away from building on her own to smoke and was found very SOB (short of breath) and tired. SPo2 returned to normal after 5-6 min. of rest and deep breathing. Pt states she is very upset this morning about missing some personal items for her apartment and decided that she was going to start smoking again." The following PT visit on 9/8/22 documented the following: "Pt (patient) with initial low Spo2 when sitting on bed (85%). With proper deep breathing, increased to 93%. Pt states she gets periods of SOB at night and often gasps for air." On 9/12/22, the third PT visit documented, "Initial Spo2 at 84% at rest; with ambulation decreased to 81-82% and increased only to 90% with 5 min of rest. Pt SOB with ambulation and exercises... MD notified of concern and possible need for O2 use. Pt states she previously used oxygen at home." Record review revealed this was the first physician notification concerning the significant change in the patient's condition noted on 9/6/22. Further, Skilled Nursing (SN) was ordered to provide visits once a week times 9 weeks. SN documented the patient's oxygen level was 90% at rest on room air during the 9/2/22 and 9/15/22 visits, with no physician notification noted. The findings above were reviewed with and acknowledged by the Administrator, Director of Nursing, and Compliance Manager (QA#1) during an interview on 10/20/22 at 10:40 AM.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure clinical notes were accurate for 1 of 7 (MR# 3) records reviewed, resulting in the potential to negatively affect the health and well-being of these patients. Findings include: MR#3: The Start of Care (SOC) was dated 6/24/22. The Plan of Care (POC) identified diagnoses of Lymphedema, Venous Insufficiency and Congestive Heart Failure. During record review on 10/19/22, it was noted that the POC ordered Skilled Nursing (SN) at a frequency of 1w1 (1 time a week for 1 week), 2w4. The Comprehensive Assessment dated 6/24/22 documented a weight of 440 and stated, “Overall Summary:…pt (patient) reported his weight at PCP (Primary Care Physician) to be 440 lbs and agreeable to obtain baseline weight at next visit…” The following two SN visits, 6/28/22 and 7/1/22 containing to weight documentation. 7/5/22 the SN documented an “Actual” weight of 429. The following visits on 7/8/22, 7/21/22 and SN discharge on 7/26/22 contained no weight documentation. The POC dated 6/24/22 contained the order, “Clinician to notify physician if there is a weight gain of 3 pounds in one day or 5 pounds or more in one week. The agency failed to ensure that the medical record was complete and accurate. These findings were reviewed with and acknowledged by the Administrator (Adm.#1) and Compliance Manager (QA#1) during an interview on 10/20/22 at 11:40 am.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure a transfer summary was sent to the physician/receiving facility within 2 business days of the patient's transfer for 1 (MR #4) of 1 record in which the patient was transferred to an inpatient facility; and failed to maintain documentation concerning when discharge summaries were sent to the physician for 2 (MR #5, 6) 2 discharge records, from a total of 7 records reviewed, resulting in the physician/receiving facility not having knowledge of the patient's health status at the time of transfer/discharge and the potential for unmet post-transfer needs. Findings include: Agency Policy: "Transfer/Referral Criteria" 9.29.2 (Revised March 2018) stated, "Transfer Summary will be provided: Within two business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time the Agency becomes aware of the transfer." Agency Policy: "Discharge Summary" 9.31.1 (Revised March 2018) stated, "A Discharge Summary will be sent within 5 business days of patient discharge to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient." MR #4: The start of care (SOC) date was 7/12/2022, with diagnoses which included cellulitis of abdominal wall, hypertensive chronic kidney disease, diabetes-type 2, and dependence on supplemental oxygen. During the record review on 10/18/22, it was noted that the patient on 7/14/22 was transferred to the hospital and admitted due to lethargy and hypoglycemia (low blood sugar). On 10/19/22, the Administrator (Adm.#1) was queried when the transfer summary was sent to the receiving hospital. Adm.#1 replied, "I'll check on it for you." On 10/20/22, Adm.#1 provided documentation which confirmed the transfer summary was sent on 7/26/22; 12 days after becoming aware of the transfer. MR#5: The SOC date was 4/11/2022, with diagnoses that included chronic obstructive pulmonary disease, pneumonia, and hypertension. On 10/18/22, record review noted the patient was discharged from the Agency on 5/26/22. On 10/19/22, Adm.#1 was queried when the discharge summary was sent to the physician. Adm.#1 replied, "I'm not sure if we have that." On 10/20/22, Adm.#1 confirmed the Agency could not provide documentation which confirmed when the discharge summaries were sent out to the physician. MR #6: The SOC date was 4/2/2022, with diagnoses that included hypertensive heart disease, congestive heart failure, and dysphagia (difficulty swallowing). On 10/19/22, record review noted the patient was discharged from the Agency on 5/25/22. On 10/19/22, Adm.#1 was queried when the discharge summary was sent to the physician. On 10/20/22, Adm.#1 confirmed the Agency could not provide documentation which confirmed when the discharge summaries were sent out to the physician. The findings above were reviewed and acknowledged by the Administrator (Adm.#1) and Compliance Manager (QA#1) during an interview on 10/20/22 at 11:25 AM. The Agency failed to adhere to its own policy referenced above in ensuring transfer summaries were sent timely and failed to maintain discharge summary documentation needed to show compliance per this requirement.