Every finding on record at Alliance Care Services, Inc

The following Condition level citation was identified at an Emergency Preparedness Survey along with a Covid-19 Focused Infection Control Survey, conducted by the Michigan Department of Licensing and Regulatory Affairs on 2/23/21 through 2/26/21 at: Alliance Care Services 5860 N. Canton Center Rd., Suite 360 Canton, MI 48187 At the time of the survey, Alliance Care Services, was was found to be non-compliant with the requirements for the Conditions of Participation at: 42 CFR §484.102, Emergency Preparedness.

Establishment of the Emergency Program (EP) CFR(s): 484.102 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to develop an emergency preparedness plan that must be reviewed and updated at least every 2 years, and included guidance for the Covid-19 pandemic, resulting in lack of direction for Agency personnel in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all 6 directly employed staff, 5 regularly utilized contracted staff and all 14 patients actively serviced by this Agency in the event of a facility emergency or disaster (E0004); failed to ensure an emergency plan existed that was based on a documented facility and community based risk assessment from an all hazards approach, including strategies for the Covid-19 global pandemic, resulting in the potential for lack of preparedness and poor patient and staff outcomes, in the event of an actual emergency (E0006); facility failed to develop and maintain an emergency preparedness communication plan that included contact information for all current staff, patient's physicians and volunteers, as appropriate, which had the potential to negatively affect the health and safety of the 14 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency (E0030); failed to ensure all staff received initial and annual training in the Agency's emergency preparedness program, including training on the Covid-19 pandemic, resulting in staff being ill-prepared in the event of an actual disaster or emergency. This deficient practice has the potential to negatively affect the 6 direct staff and 5 contracted staff employed by this agency, and all 14 patients currently serviced by this Agency (E0037). The cumulative effect of these systemic problems could potentially have a negative effect on all patients cared for by the home health agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop an emergency preparedness plan that must be reviewed and updated at least every 2 years, and included guidance for the Covid-19 pandemic, resulting in lack of direction for Agency personnel in the event of an actual emergency or disaster. This deficient practice could affect the health and safety of all 6 directly employed staff, 5 regularly utilized contracted staff and all 14 patients actively serviced by this Agency in the event of a facility emergency or disaster. Findings include: On 2/23/21 at 2:30 p.m., the Administrator (Adm #1) was asked for permission to review the agency's Emergency Preparedness documentation. Upon receipt and review of the documents, it was noted that the plan, revised 1/2020, had no language that addressed the Covid-19 global pandemic. There was no documented evidence that showed the agency had developed an Emergency Preparedness plan that had been reviewed/updated in accordance with the requirements of this section. These findings were reviewed with and confirmed by the Administrator during the time of discovery.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(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 LTC facilities at §483.73(a)(1):] 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)(1):] 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. * [For Hospices at §418.113(a)(2):] 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. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure an emergency plan existed that was based on a documented facility and community-based risk assessment from an all-hazards approach, including strategies for the Covid-19 global pandemic, resulting in the potential for lack of preparedness and poor patient and staff outcomes, in the event of an actual emergency. Findings include: On 2/23/21 at 2:30 p.m., the agency's Emergency Preparedness documents were reviewed. The Risk Assessments, dated 1/4/2021 were noted to have identified Community and Facility based risks. There was no mention of the Covid-19 global pandemic in the agency's Risk Assessments. Further, the agency's Emergency Preparedness Plan failed to include strategies to address the Covid-19 global pandemic or any of the possible threats identified in the risk assessments. These findings were reviewed with and confirmed by the Administrator (Adm #1) at the time of discovery and again on 2/26/21 at 10:20 a.m.

Names and Contact Information CFR(s): 484.102(c)(1) [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the facility failed to develop and maintain an emergency preparedness communication plan that included contact information for all current staff, patient's physicians and volunteers, as appropriate, which had the potential to negatively affect the health and safety of the 14 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency. Findings include: During a review of the agency's emergency preparedness documents on 2/23/21 and 2/26/21, it was noted that there was no contact information for all current staff, patient's physicians or volunteers as appropriate. These findings were reviewed with and confirmed by Adm #1 during an interview on 2/26/21 at 10:30 a.m.

EP Training Program CFR(s): 484.102(d)(1) *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure all staff received initial and annual training in the Agency's emergency preparedness program, including training on the Covid-19 pandemic, resulting in staff being ill-prepared in the event of an actual disaster or emergency. This deficient practice has the potential to negatively affect the 6 direct staff and 5 contracted staff employed by this agency, and all 14 patients currently serviced by this Agency. Findings include: On 2/23/21 at 2:30 p.m., the agency's Emergency Preparedness documentation was requested and reviewed. On 2/26/21 at 10:30 a.m., a request was made to review the staff's initial training in emergency preparedness that included the topic of Covid-19, as well as follow up training (every 2 years). With the Administrator (Adm #1) present, it was acknowledged that none of the agency's 5 regularly staffed contracted employees had received initial or ongoing training in Emergency Preparedness. Further, none of the contracted staff had received training in Covid-19. These findings were reviewed with and acknowledged by Adm #1 at the time of discovery.

On 2/23/21 through 2/26/21, the Michigan Department of Licensing and Regulatory Affairs conducted a Medicare authorized Recertification survey along with a COVID-19 Focused Infection Control survey at: Alliance Care Services 5860 N. Canton Center Road, Suite 360 Canton, MI 48187 Records reviewed: 3 records with home visits and 4 records without home visits, for a total of 7 records reviewed. This agency has no branch locations. The following condition level deficiencies were identified during the survey: 42 CFR §484.55 Comprehensive assessment of patients 42 CFR §484.102 Emergency Preparedness As a result of the Condition level noncompliance on 2/26/21, 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).

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the patient received proper written notice (Notice of Medicare Provider Non-Coverage) in advance of the agency terminating on-going care for 1 (MR# 4) of 2 discharged records, resulting in the patient being denied the right to appeal the decision to end Medicare covered services. Findings include: MR #4: The patient's start of care was 10/19/20 with diagnoses that included Chronic Obstructive Pulmonary Disease, Respiratory Failure with hypoxia and generalized osteoarthritis. The record review conducted on 2/23/21 at 1:15 p.m. revealed the following: The plan of care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT) and Home Health Aide (HHa) services to be provided. The patient discharged from PT on 11/2/20 and discharged from SN and the agency's services on 11/17/20. Further review of the clinical record revealed that the patient was provided and signed the "Notice of Medicare Provider Non-Coverage" on 11/17/20, which was the same day the patient was discharged from the agency. The Agency failed to ensure the patient received proper written notice (Notice of Medicare Provider Non-Coverage) in advance of the agency terminating on-going care. These findings were reviewed with and acknowledged by the Administrator (Adm #) during an interview on 2/26/21 at 11:30 a.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: This Condition of Participation has NOT been met. As evidenced by: Based on record review and interview, it was determined that the Agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status for 4 of 7 (MR# 2, 3, 4 and 6) records reviewed, resulting in incomplete clinical information to aide in determining the needs of these patients and for measuring the patient's progress toward goals/outcomes (G528); and failed to ensure the physician was notified of potential drug interactions and duplicate drug therapy for 6 of 7 (MR# 1, 2, 3, 4, 5 and 7) records reviewed, resulting in the potential for harmful medication effects for these patients (G536). The cumulative effect of these systemic problems could potentially have a negative effect on the agency's ability to provide quality care as a Condition of Participation, in the area of: Comprehensive Assessment of Patients 42 CFR §484.55.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status for 4 of 7 (MR# 2, 3, 4 and 6) records reviewed, resulting in incomplete clinical information to aide in determining the needs of these patients and for measuring the patient's progress toward goals/outcomes. Findings include: MR#2: This 51-year-old patient was admitted to the agency on 2/10/21 with diagnoses of left heel pressure ulcer, paraplegia, and lumbar spina bifida. During record review on 2/24/21, it was noted that the 2/10/21 comprehensive assessment sections M1021 Primary Diagnosis and M1023 Other Diagnoses listed 12 diagnoses all with the same onset/exacerbation date of 2/5/21. The exacerbation/onset dated 2/5/21 included the patient's diagnoses of paraplegia, lumbar spina bifida, bed confinement status, neuromuscular dysfunction of bladder, and morbid obesity. These diagnoses are typical of long-standing chronic disease processes and not those with a sudden onset/exacerbation on 2/5/21. MR#3: This 73-year-old patient was admitted to the agency on 1/15/21 with diagnoses of drug induced adrenal insufficiency, rheumatoid arthritis, diabetes, and lymphedema. During record review on 2/24/21, it was noted that the 1/15/21 comprehensive assessment sections M1021 Primary Diagnosis and M1023 Other Diagnoses listed 21 diagnoses all with the same onset/exacerbation date of 1/5/21. The exacerbation/onset dated 1/5/21 included the patient's diagnoses of obstructive sleep apnea, long term use of anticoagulants, long term use of oral hypoglycemic drugs, body mass index, and morbid obesity. These diagnoses are typical of long-standing chronic disease processes and not those with a sudden onset/exacerbation on 1/5/21. The agency failed to follow its own policy titled, Initial Assessments/Comprehensive Assessments (revised 1/20) which states: The assessment will reflect the patient's current health status and include information to demonstrate the patient's progress toward achievement of desired outcomes... also includes...relevant diagnoses and current health status, including all active health and medical problems...relevant medical history. These findings were reviewed with and acknowledged by the Director of Nursing (Don#1) during an interview on 2/25/21 at 12 noon. MR 4: The patient's start of care (SOC) was 10/19/20 with diagnoses that included COPD, post Covid-19 and chronic respiratory failure with hypoxia. The clinical record review was conducted on 2/23/21 at 1:15 p.m. The Initial Comprehensive Assessment dated 10/19/20 completed by the Registered Nurse revealed the following: Section 1021 Primary diagnosis listed a primary diagnosis of COPD with an exacerbation date of 10/5/20. Section 1023 "Other diagnoses" listed spondylosis, generalized arthritis, idiopathic gout and primary hypertension. All diagnoses had an exacerbation date of 10/5/20. There was no history of the status of the above diseases including onsets, treatments for past medical history problems and outcomes from the treatments. Further, there was no documentation of the events that led to the need for home care. These findings were reviewed with and acknowledged by the Director of Nursing (DON #1) during an interview on 2/25/21 at 11:35 a.m. MR #6: The patient's SOC was 1/28/21 with diagnoses that included Pneumonia due to Pseudomonas, Covid-19, diabetes mellitus and pressure ulcer left heel. The clinical record review was conducted on 2/24/21 at 1:15 p.m. The Initial Comprehensive Assessment dated 12/21/20 completed by the Registered Nurse revealed: Section 1021 Primary diagnosis listed Pneumonia due to Pseudomonas, with an exacerbation date of 1/25/21. Section M1023/Other Diagnoses listed Covid-19, diabetes mellitus, pressure ulcer left heel and Atherosclerotic heart disease. All the listed diagnoses had an exacerbation date of 1/25/21. The exacerbation date listed for Atherosclerotic heart disease was 1/1/21. There was no history of the status of the above diseases including onsets, treatments for past medical history problems and outcomes from the treatments. Further, there was no documentation of the events that led to the need for home care. These findings were reviewed with and acknowledged by DON #1 during an interview on 2/25/21 at 11:00 a.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 Initial and Resumption of Care Comprehensive Assessments included a review of all medications to determine any interactions, adverse effects and duplicate drug therapy in 6 (MR#'s 1, 2, 3, 7, 5 and 4) records with major interactions identified, and failed to ensure the Physician was notified of the identified reactions, from a total of 7 records reviewed, resulting in the potential for harmful medication effects for all 25 patients currently serviced by this Agency. Findings include: MR#1: This 77-year-old patient was admitted to the agency on 3/4/20 with diagnoses of aftercare following a right knee joint replacement, congestive heart failure, and diabetes. The clinical record was reviewed on 2/23/21. The 3/4/20 comprehensive assessment completed by DON#1 (director of nursing) indicates for (M2001) drug regimen review that no clinically significant medication issues were found during the review of the patient's medications. Utilizing the website, Drugs.com on 2/23/21, the patient's medications are entered, and a drug interaction report is generated that indicates there are 5 major interactions, 25 moderate interactions, and 3 minor interactions. The website classifies a major interaction as follows: highly clinically significant, avoid combinations; the risk of the interaction outweighs the benefit. There was no documentation to indicate that DON#1 had utilized the agency's medical record software or other websites to identify significant drug interactions or duplicate drug therapy for the patient's 16 medications listed on the plan of care. There was no documented evidence the physician was notified of the potential drug interactions. MR#2: This patient was admitted to the agency on 2/10/21 with diagnoses of left heel pressure ulcer, paraplegia, and lumbar spina bifida. The clinical record was reviewed on 2/24/21. The 2/10/21 comprehensive assessment completed by DON#1 indicates for (M2001) drug regimen review that no clinically significant medication issues were found during the review of the patient's medications. Utilizing Drugs.com on 2/24/21, the drug interaction report indicates that there is one major interaction indicated for the patient's medications of Gabapentin and Tramadol. There was no documentation to indicate that DON#1 had utilized the agency's medical record software or other websites to identify significant drug interactions or duplicate drug therapy for the patient's 17 medications listed on the plan of care. There was no documented evidence the physician was notified of the potential drug interactions. MR#3: This 73-year-old patient was admitted to the agency on 1/15/21 with diagnoses of drug induced adrenal insufficiency, rheumatoid arthritis, diabetes, and lymphedema. The clinical record was reviewed on 2/24/21. The 1/15/21 comprehensive assessment completed by the RN (registered nurse) indicates for (M2001) drug regimen review that no clinically significant medication issues were found during the review of the patient's medications. Utilizing the website, Drugs.com on 2/25/21, the drug interaction report indicates there are 4 major interactions, 40 moderate interactions, and 8 minor interactions. There was no documentation to indicate the RN had utilized the agency's medical record software or other websites to identify significant drug interactions or duplicate drug therapy for the patient's 31 medications listed on the plan of care. There was no documented evidence the physician was notified of the potential drug interactions. The medications listed on the 1/15/21 plan of care included 6 duplicate drugs with different dosages and frequencies. The duplicate drugs include: Aspirin, Amlodipine Besylate, Furosemide, Gabapentin, Metoprolol Tartrate, and Cholecalciferol. There was no documentation to indicate the RN recognized the duplicate drug therapy and no documentation the RN contacted the patient's physician to clarify the 6 duplicate medications. During a joint survey home visit with the occupational therapist on 2/25/21, the patient was shown the list of medications on the plan of care and asked if the duplicate medications were correct. MR#3 looked over the medication list and pointed to the six duplicate medications and stated she was no longer on these medications. MR#3 explained that she was on those medications at those doasages and frequencies before her hospital stay from 1/7/21 to 1/14/21. The medications, dosages, and frequencies were changed after she was discharged from the hospital. The nurses failed to follow agency policy titled, Medication Reconciliation (revised 3/2018) which states, "The Agency will reconcile patient's medications at time of admission and on an ongoing basis 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 non-compliance with drug therapy... Any concerns or discrepancies will be reconciled by a RN with the patient's physician." The findings were reviewed with and acknowledged by DON#1 during an interview on 2/25/21 at 12 noon. MR #7: The patient's start of care (SOC) was 11/3/20 with diagnoses that included cellulitis right leg, wound right great toe and COPD. On 2/24/21 at 2:15 p.m., during the clinical record review, section M2001 of the "Initial Comprehensive Assessment" dated 12/16/19, completed by the Registered Nurse, documented, "No - No issues found during (medication) review." The patient's 25 prescribed medications were entered in "Drugs.com" (online medication interaction checker) and revealed: 8 major drug to drug interactions, 42 moderate drug to drug interactions, 9 drug to food interactions and 6 duplicate drugs. There was no documented evidence that a drug review had been conducted at the SOC to determine any untoward reactions. Further review revealed the patient was transferred to an inpatient facility on 12/9/20, as result of a fall with fracture, and resumed home care services on 12/16/20. There was no documented evidence that the Registered Nurse conducted a drug review upon resumption of care. MR #5: The patient's SOC was 2/4/21 with diagnoses that included cellulitis left leg, laceration right forearm, and contusion right ear. On 2/23/21 at 1:45 p.m., during the clinical record review, it was noted that section M2001 of the "Initial Comprehensive Assessment" dated 2/4/21, completed by the Registered Nurse, documented, "No - No issues found during (medication) review." The patient's 14 prescribed medications were entered in Drugs.com and revealed 8 major drug to drug interactions, 22 moderate drug to drug interactions, 7 drug to food interactions and 4 duplicate drugs. There was no documented evidence that a drug review had been conducted at the SOC to determine any untoward reactions. MR #4: The patient's SOC was 10/19/20 with diagnoses that included Chronic COPD, Post Covid-19, and Chronic respiratory failure. On 2/23/21 at 11:15 a.m., during the clinical record review, it was noted that section M2001 of the Initial Comprehensive Assessment dated 10/19/20, completed by the Registered Nurse, documented, "No - No issues found during "medication) review." The patients 11 drugs were entered into Drugs.com and revealed 4 major drug to drug interactions, 4 moderate drug to drug interactions, 4 drug to food interactions and 1 duplicate drug. There was no documented evidence that a drug review had been conducted at the SOC to determine any untoward reactions. The above findings were reviewed with the Director of Nursing (DON #1) during an interview on 2/25/21 at 10:40 a.m. When queried about the process used to determine the presence of any untoward drug interactions, DON #1 reported, "I gather all the patient's medications when I'm in their home. I list each medication on the medication profile and I go over the medications with the patient. I determine if there are any interactions based on my knowledge."

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 included the frequency of wound care treatments for 1 of 1 (MR# 2) records reviewed with wound care orders, resulting in the potential for poor patient outcomes for this patient. Findings include: MR#2: This patient was admitted to the agency on 2/10/21 with diagnoses of left heel pressure ulcer, paraplegia, and lumbar spina bifida. During record review on 2/24/21, it was noted that the plan of care (POC) orders the skilled nurse (SN) to provide two visits each week for six weeks and to provide the following wound care: "cleanse site with vashe moistened gauze for 5 minutes. Cut out and packed Aquacel Ag Advantage with tail out. Triad Hydrophilic paste around the peri wound. Moisturize surrounding skin, cover wound with gauze and Kerlix and secure with double layer Tubigrip." There was no information on the POC to indicate how often the dressing was to be changed to promote wound healing. The referral for home care services fax stamped 2/8/21, orders wound care as previously detailed and includes the statement that the dressing is to be changed every other day. The SN provides two visits each week, it is unclear who will provide wound care "every other day" as ordered. The POC fails to indicate whether the patient or a caregiver will do dressing changes or whether the nurse should provide visits every other day to ensure wound care is completed. The findings were reviewed and acknowledged by DON#1 (director of nursing) during an interview on 2/25/21 at 12 noon.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to ensure the Physician was promptly notified of 1 (MR #7) of 1 patient who sustained a fall with injury, that resulted in hospitalization, from a total of 7 records reviewed, resulting in the potential for MR #7: The patient's start of care was 11/3/20 with diagnoses that included cellulitis right leg, wound right great toe and chronic obstructive pulmonary disease. During the clinical record review on 2/24/21 at 1:07 p.m., it was noted that the patient was transferred to the hospital by the Director of Nursing (DON #1) on 12/9/20. During the review, it was discovered that the patient had a fall at home with resultant left ankle fracture. A "Transfer Summary" dated 12/9/20 documented that the patient was sent to Beaumont Hospital. The area titled "Summary of Care" stated, "Most items of 485 plan of care have been instructed." The document further stated, "transfer summary will be sent to MD (Doctor)..." There was no statement detailing the reason for the patient's transfer to the hospital. Additionally, there was no documentation in the visit notes or communication notes that indicated the Physician had been promptly notified of the patient's fall or reason for transfer to the hospital. These findings were reviewed with and acknowledged by DON #1 during an interview on 2/25/21 at 10:39 a.m.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview and record review, the agency failed to ensure the Home Health Aide followed accepted standards of practice in Infection Control for 1 (MR #5) of 1 patient observed during a home visit, from a total of 7 records reviewed, resulting in the potential for the development and spread of infection. Findings include: MR #5: The patient's start of care was 2/4/21 with diagnoses that included cellulitis left lower leg, laceration right forearm and contusion right ear. During the clinical record review on 2/23/21 at 1:45 p.m., it was noted that the plan of care ordered Home Health Aide (HHa) services to be provided 1x/wk. x 4 wks. to provide assistance with activities of daily living, dressing and housekeeping. On 2/24/21 at 10:30 a.m. a home visit was conducted with HHa #1. Prior to rendering care/services, HHa #1 placed 2 bags on the patient's dining room table. The bags contained HHa #1's work equipment and other items that could not be determined. HHa #1 did not place a barrier between the patient's table and her work equipment. Upon completion of the visit, HHa #1 was queried as to why she didn't place a barrier on the patient's table and reported, "I don't know why I didn't, because I have them (barrier cloths) with me."

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 observation, record review, and interview the agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control of infectious and communicable diseases including Covid-19 as an integral part of the agency's quality assessment and performance improvement program, and failed to develop a method of screening visitors and staff employed by the agency, resulting in the potential development and spread of the Covid-19 infection between staff and the agency's 25 current patients. Findings include: Upon arrival to the agency on 2/23/21 at 9:00 a.m., it was observed that there was no sign posted on the suite door that directed visitors and staff of the protocol for entering the agency. Upon entering the suite, the writer was greeted and escorted to an office desk without first being screened for Covid-19. There was no protocol in place for the screening of visitors. Throughout the survey, administrative and field staff were observed entering and exiting the agency's suite. There was no screening protocol in place for persons entering the agency's suite. On 2/26/21, the agency's QAPI (quality assessment and performance improvement) program documentation was reviewed for 2019 and 2020. There was no documented evidence the agency's QAPI program included the surveillance, identification, prevention, or control of Covid-19 or any other infectious and communicable diseases. The findings were reviewed with and acknowledged by Adm#1 (administrator) during an interview on 2/26/21 at 11:15 p.m.

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, the agency failed to ensure the registered nurse assessed the patient's weight log every visit for 2 of 2 (MR# 1, 3) patients ordered to monitor weights as indicated in the plan of care, resulting in the potential for poor patient outcomes for these two patients. Findings include: During the entrance conference on 2/23/21 at 10:35 a.m., the alternate director of nursing (DON#2) explained that the nurses carry scales with them to utilize in the event a patient does not have their own scale to monitor weights. MR#1:This 77-year-old patient was admitted to the agency on 3/4/20 with diagnoses of aftercare following a right knee joint replacement, congestive heart failure, and diabetes. During clinical record review on 2/23/21, it was noted that the initial comprehensive assessment completed by DON#1 (director of nursing) on 3/4/20, documented the patient had a reported baseline weight of 162 pounds. The 3/4/20 plan of care (POC) ordered the physician to be notified of patient "weight greater than (>) 157 lbs or less than () 207 lbs or less than (<) 197 lbs. The POC also ordered the SN to instruct the patient on daily weight self-monitoring, to report to the SN a weight gain of 3 pounds in 1 day or 5 pounds in one week, and the SN is to assess the patient's weight log every visit. The SN documented four additional visits dated 1/18/21, 1/26/21, 2/11/21, and 2/15/21. The four visit notes failed to include documentation of the patient's weight and failed to include documentation that the SN assessed the patient's weight log every visit as ordered in the plan of care. These findings were reviewed with and acknowledged by DON#1 during an interview at 12 noon on 2/25/21.

Inservice training supervised by RN CFR(s): 484.80(d)(1) In-service training may be offered by any organization and must be supervised by a registered nurse. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that home health aide in-service training was supervised by a registered nurse for 1 of 2 home health aides (HHa#2) employed by the agency for more than 12 months, resulting in a lack of registered nurse supervision to ensure in-service training content is consistent with agency policies and procedures. This deficient practice has the potential to negatively affect all 92 patients admitted to the agency in the past year. Findings include: On 2/24/21 a review of the home health aide (HHa) personnel files revealed the following: HHa#2 (home health aide): Date of hire was 10/14/09. The personnel file contained documentation from 2019 of 15 test results of various in-service topics. A review of each of the tests in 2019 indicates that 5 of 15 of the tests were signed by instructor OM#1 (office manager). The five in-service tests were dated 4/25/19, 6/17/19, 8/26/19, 9/12/19, and 10/8/19. During an interview on 2/24/21 at 1:35 p.m., OM#1 was queried regarding her signature on the five in-service tests and whether she was a licensed registered nurse (RN). OM#1 acknowledged her signature on the tests and explained that she has finished school to become a RN but has not currently passed the licensing board exam. OM#1 is not currently a RN and was not a RN when she signed the in-service tests as an instructor/RN. The agency failed to follow its own policy titled, Inservice Education (revised January 2020) which states, "Inservice training (for HHas) must be supervised by a RN. The RN must approve the content and attend the presentation to ensure that the content is consistent with Agency policies and procedures."

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure Skilled Nursing prepared clear written patient care instructions for the home health aide regarding client needs, and safety precautions prior to providing care in 3 (MR#'s 4, 6, and 7) of 4 records in which Home Health Aide services were ordered, from a total of 7 sampled records reviewed, resulting in the potential for the provision of unsafe care and unmet care needs. Findings include: MR #4: The patient's start of care (SOC) was 10/19/20 with diagnoses that included chronic COPD (chronic obstructive pulmonary disease), post Covid-19, and chronic respiratory failure. The 485/plan of care (POC) indicated the following: "Functional limitations: Poor endurance..., Safety Measures: Instructed on medical gas, slow position change, O2 (Oxygen) precautions, Anticoagulant (bleeding) precautions, proper position during meals, fall precautions..." During a review of the clinical record on 2/23/21 at 11:15 a.m., it was noted that the "Aide Care Plan" failed to include all the above-mentioned "Safety Measures." These findings were reviewed with and acknowledged by the Director of Nursing (DON #1) during an interview on 2/25/21 at 11:35 a.m. MR #6: The patient's SOC was 1/28/21 with diagnoses that included Pneumonia due to Pseudomonas, Covid-19 acute respiratory disease, diabetes mellitus and stage I pressure ulcer left heel. The POC indicating the following: "Safety Measures: Keep side rails up, slow position change, anticoagulant precautions, proper position during meals, sharps safety, fall precautions..." During a review of the clinical record on 2/24/21 at 1:15 p.m., it was noted that the "Aide Care Plan" failed to include all the above-mentioned "Safety Measures." These findings were reviewed with and acknowledged by the Director of Nursing (DON #1) during an interview on 2/25/21 at 11:35 a.m. MR #7: The patient's SOC was 11/3/20 with diagnoses that included cellulitis right leg, wound right great (big) toe and COPD. The POC indicating the following: "Patient Risk Profile: History of falls with injury, Decline in mental/emotional/behavioral status..., Safety Measures: slow position change, anticoagulant precautions, proper position during meals, fall precautions..." During a review of the clinical record on 2/24/21 at 1:07 p.m., it was noted that the "Aide Care Plan" failed to include all the above-mentioned "Safety Measures" as well as areas identified in the patient risk profile. These findings were reviewed with and acknowledged by the Director of Nursing (DON #1) during an interview on 2/25/21 at 11:35 a.m.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the Agency failed to ensure the Home Health Aide provided care and services as ordered in the plan of care for 1 (MR #5) of 1 patient observed during an Aide home visit, of 4 patients with Home Health Aide services ordered, from a total of 7 sampled records reviewed, resulting in the patient not receiving care and services as ordered and unmet needs. Findings include: MR #5: The patient's start of care was 2/4/21 with diagnoses that included cellulitis lower leg, laceration right forearm, contusion right ear and chronic kidney disease. The clinical record review was conducted on 2/23/21 at 1:45 p.m. and revealed the following: The plan of care (POC) ordered Home Health Aide (HHa) services at a frequency of 1x/wk. x 4 wks. The "Aide Care Plan" dated 2/4/21 indicated the following tasks were to be performed every visit: Vitals signs, record bowel movement, assist with ambulation and transfers, change linen, light housekeeping, make bed, assist to dress, shower, comb hair and check pressure sores. During a home visit on 2/24/21, HHa #1 assisted the patient with a shower. Upon completion of the shower, HHa #1 was directed to a large puddle of water on the bathroom floor in the patient's walking path. HHa #1 placed a towel over the water on the floor. The patient declined assistance with getting dressed and having her hair combed stating, "I can do that part myself. HHa #1 then placed the dirty towel over a rack in the patient's bathroom. HHa #1 did not tidy up the bathroom after the shower. HHa #1 then took the patient's vital signs and had the patient sign off on the visit note. HHa #1 stated, "I'll see you next week. Did you need anything else?" The patient responded, "I need light dusting." HHa #1 replied, "Okay." HHa #1 then packed up her equipment and exited the patient's home. Of the above ordered tasks, HHa #1 failed to record the patient's bowel movement, change linen, light housekeeping, or make the bed. HHa #1 failed to provide care and services as ordered in the plan of care. HHa #1 acknowledged these observations during a post visit interview on 2/24/21 at 11:20 a.m. These findings were also reviewed with and acknowledged by the Director of Nursing (DON #1) during an interview on 2/25/21 at 11:20 a.m. who reported, "I'll have to do some education with her (HHa #1)."

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure that at least one qualifying service was provided directly by agency employees for 1 of 1 (Contract# 1) contract reviewed, resulting in the potential for all services to be provided by contracted staff. This deficient practice could negatively affect all 92 patients admitted in the past year. Findings include: During the entrance interview on 2/23/21 at 10:35 a.m., the alternate director of nursing (DON#2) explained that aide services were provided directly by the agency. On 2/25/21, the agency's contract with Contractor#1 for services was reviewed. Contract#1: The contract dated January 17, 2020, agrees to provide registered nurse, physical therapy, occupational therapy, speech therapy, medical social work, and home health aide services. These are all the same services that the agency provides. All services have the potential to be provided by contracted staff. There was no documented evidence that the agency provides at least one service directly by agency employees. The findings were reviewed with and acknowledged by Adm#1 (administrator) during an interview on 2/25/21 at 3:26 p.m.

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 that a completed and detailed transfer summary was sent to the receiving facility for 1 (MR #7) of 1 patient who sustained a fall with injury requiring transfer to an inpatient facility, from a total of 7 records reviewed, resulting in lack of continuity of care and the potential for unmet care needs. Findings include: Policy: "Transfer/Referral Criteria and Planning", 1/2020 stated, "A written Transfer Summary concerning the Agency ' s involvement with the patient, e.g., patient condition at transfer, lab data, patient outcomes in meeting goals in the plan of care, instructions/referrals provided to patient, current reconciled medication list, advance directives, any continuing symptom management needs, e.g., pain, nausea or dyspnea, and reasons for transfer or referral will be completed." MR #7: The patient's start of care (SOC) was 11/3/2020 with diagnoses that included cellulitis right leg, wound right great toe. On 2/24/21 at 1:07 p.m. during a review of the clinical record, it was noted that the patient was transferred to an inpatient facility on 12/9/2020. A documented titled "Transfer Summary" dated 12/9/21 completed by the Director of Nursing (DON #1) documented, "Reason for Transfer: Hospitalized..., Summary of Care: Most items of 485 plan of care have been instructed..." The summary was void of any information as to why the patient was transferred to the hospital or status at the time of transfer. Additionally, there were no communication or visit notes detailing the reason for the inpatient transfer. These findings were reviewed with and acknowledged by DON #1 during an interview on 2/25/21 at 10:39 a.m. who reported, "I see what you're saying. If I'm just reading this (transfer summary), I wouldn't be able to tell why the patient was transferred to the hospital."

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation and interview, the agency failed to ensure that clinical records were properly stored, secured and safeguarded against loss or unauthorized use resulting in the potential for compromise of protected health information for all past and current patients serviced by the agency. Findings include: Policy: "Information management Plan", 3/2018 stated, "Patient records are kept in a locked location with limited access..., Original clinical notes are stored in a file cabinet..., All patient information and personnel information is strictly confidential." On 2/23/21 at 9:10 a.m., upon arrival and entrance into the Agency suite, patient files were observed in a rack on the front desk. Patient names were visible. A tour of the office area revealed the presence of patient's charts on desks next to a window. Patient charts were observed in boxes on desks and floors. A total of 17 boxes of patient files as well as open charts were observed in an unsecured manner. File cabinets were observed in one of the offices which were being utilized to store employee files and personal protective equipment. The Agency failed to ensure that the clinical records were safeguarded against loss or unauthorized use. During the tour, the Administrator (Adm #1) reported, "We moved all our files in this room from another office in order to save money. These findings were observed and confirmed by Adm #1 at the time of discovery.