Every finding on record at Michigan Home Health Services, Inc

On 4/15/24 through 4/18/24, the Michigan Department of Licensing and Regulatory Affairs conducted a recertification survey at Michigan Home Health Services. This was a standard survey. The requirements for participation in Medicare at 42 CFR Part § 484.102 Emergency Preparedness were not reviewed.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 4/15/24 through 4/18/24 at: Michigan Home Health Services 33730 Freedom Rd. Suite A Farmington Hills, MI 48335 The agency had no other locations. For this survey 3 home visits (only 3 visits were available) with record reviews, 4 active records without a home visit and 3 discharged records were reviewed. At the conclusion of the survey the agency was found to be out of compliance with standard level deficiencies for the conditions of participation for home health agencies at: 42 CFR Part 484.

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, the agency failed to ensure the comprehensive assessment included a review of all medications to determine any duplicate therapy or adverse effects and failed to ensure the physician was notified of potential drug interactions or duplicate therapy in 1 of 10 (P-6) records reviewed, resulting in the potential for harmful medication effects for the 365 patients serviced by this agency in the past 12 months. Findings include: P-6: This patient was admitted to the agency on 8/18/23 with diagnoses of aftercare following a left knee replacement. During record review on 4/15/24, it was noted that the written medication profile lists16 different medications for this patient. The plan of care lists 9 medications. The patient medication record lists 9 medications that were checked for duplicate drug therapy and drug interactions. There was no indication that the remaining 7 medications (Colace, Ferrous Sulfate, Lescal, Loratadine, Toprol XL, Prilosec, and Osteo Bi-Flex) were considered in total for duplicate therapy or drug interactions. There was no indication that the physician was informed that all the patient's medications had been included in a review to determine duplicate drug therapy or potential drug interactions. The findings were reviewed with and acknowledged by the Administrator and the Director of Clinical Services during an interview on 4/18/24 at 9:50 a.m.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure 2 of 10 (P-1, 6) patients received care and services as ordered, from a total of 10 sampled records reviewed, resulting in the potential for unmet care needs and further physical decline. Findings include: P-6: The patient was admitted to home care on 8/18/23 with a diagnosis of aftercare following a left knee joint replacement. The 8/17/23 hospital referral for home care services instructed the agency to provide skilled nursing, physical therapy, and home health aide services. The 8/18/23 start of care comprehensive assessment documents that the patient has her sister staying for one week to assist the patient. The assessment also notes that the patient needs assistance with grooming, putting on upper body clothing, bathing at sink or bed, and toileting. The patient depends entirely upon another person to dress the lower body. This indicates the patient could benefit from the provision of aide services. During record review on 4/15/24 it was noted that aide services were not provided. Aide services were not listed on the plan of care. There was no documentation in the comprehensive assessment to indicate the patient had declined aide services. There was no documentation on the plan of care that the patient had declined aide services. It was unable to be determined whether the patient had declined aide services or that the agency had not offered to provide aide services. During an interview on 4/18/24 at 9:50 a.m., the findings were reviewed with the Administrator (Staff-1) and the Director of Clinical Services (Staff-2). Staff-1 stated that most of their patients decline aide services but was unable to provide documentation that the patient had declined aide services. P-1: The patient's SOC was 3/15/23, with diagnoses that included hemiplegia, pain, and falls. During record review on 4/15/24, it was noted that the POC ordered occupational therapy (OT) services to evaluate and treat. During review of the record, it was discovered that OT never made a visit to the patient. There was no documentation in the record to explain why OT services were not provided, and there was no documented evidence the physician had been notified of OT services not being provided as ordered. The above findings were reviewed with and acknowledged by the Administrator (Staff-1) during an interview on 4/18/24 at 2:10 p.m.

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the plan of care was updated to reflect changes in the patient's medications for 1 of 10 (P-8) records reviewed, resulting in the potential for harmful medication effects for this patient. Findings include: P-8: This patient was admitted to the agency on 4/4/24 with diagnoses of aftercare following a right hip joint replacement. During a joint survey home visit with the physical therapist (PT) on 4/17/24 at 11:00 a.m., the patient was queried regarding her pain. The patient explained that she's been taking Tramadol for pain, and it's been helpful. She stopped taking Percocet and Tylenol. During review of the patient's medication record, it was noted that Tramadol is not included in the patient's medication list. Observation of the patient's Tramadol medication bottle indicates the patient is to take Tramadol 50 mg 1 tablet every 6 hours as needed for pain. The pill bottle was filled on 4/9/24. The PT made visits to the patient on 4/10/24, 4/12/24, and 4/15/24 without noting the change in the patient's medication. The PT failed to update the patient's medication list and the plan of care to reflect the patient's current information. The findings were reviewed with and acknowledged by the Administrator and the Director of Clinical Services during an interview on 4/18/24 at 9:50 a.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 the discharge summaries were sent to the physician within 5 business days of discharge in 3 (P-1, 6, 7) of 3 records in which the patient was discharged from the agency's services, from a total of 10 sampled records reviewed, resulting in the potential for unidentified continuing health concerns and unmet care needs. Findings include: P-6: This patient was admitted to home care on 8/18/23 with a diagnosis of aftercare following a left knee joint replacement. During record review on 4/15/24, it was noted that the patient was discharged from the agency on 9/29/23. There was no documented evidence that the discharge summary was sent to the physician within 5 days of discharge. The findings were reviewed with and acknowledged by Staff-1 and the Director of Clinical Services (Staff-2) during an interview on 4/18/24 at 9:50 a.m. P-7: This patient was admitted to home care on 11/20/23 with a diagnosis of aftercare following a left knee joint replacement. During record review on 4/16/24, it was noted that the patient was discharged from the agency on 12/15/23. There was no documented evidence that the discharge summary was sent to the physician within 5 days of discharge. The findings were reviewed with and acknowledged by Staff-1 and Staff-2 during an interview on 4/18/24 at 9:50 a.m. P-1: The patient's SOC was 3/15/23, with diagnoses that included hemiplegia, pain, and falls. During record review on 4/15/24, it was noted that the patient's discharge date was 4/27/23. There was no documented evidence in the record that the discharge summary had been sent to the physician. The above findings were reviewed with and acknowledged by the Administrator (Staff-1) during an interview on 4/18/24 at 2:10 p.m.

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 4/20/21 through 4/23/21 at: Michigan Home Health Services 33730 Freedom Rd., Suite A Farmington Hills, MI 48335 At the time of the survey, Michigan Home Health Services, 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: This Condition of participation has NOT been met. Based on record review and interview, the Agency failed to develop an emergency preparedness plan that must be reviewed, updated, 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 directly employed staff, regularly utilized contracted staff and all 25 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); failed to develop an Emergency Preparedness policy/Plan, that included the use of volunteers, as appropriate, and/or other emergency staffing strategies to address surge needs during the COVID-19 crisis, resulting in the potential for the interruption in needed care and services for staff and all 25 patients currently serviced by this agency (E0024); 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 25 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency (E0030); failed to provide initial training in emergency preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, and failed to maintain documentation of training's, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services (E0037); and, failed to provide documentation for the required community/facility based full-scale exercises and failed to provide documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff being ill-prepared in the event of an actual emergency. This deficient practice could negatively affect all 25 patients currently serviced by this Agency (E0039). 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, updated 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 directly employed staff, regularly utilized contracted staff and all 25 patients actively serviced by this Agency in the event of a facility emergency or disaster. Findings include: On 4/8/21 at 2:15 p.m., the agency's Emergency Preparedness documentation was reviewed. During the review, it was noted that the agency had no completed plan accessible and available for review. 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 4/20/21 at 11:30 a.m., the agency's Emergency Preparedness documents were reviewed with the Administrator (Adm #1) and Clinical Manager (CM #1) present. The Risk Assessment document was noted to be blank. During the review, Adm #1 searched for "additional binders" that may have a completed Risk Assessment. Adm #1 acknowledged she could not locate a completed Risk Assessment. Further, the agency's Emergency Preparedness documents failed to include strategies to address the Covid-19 global pandemic. These findings were reviewed with and confirmed by the Administrator (Adm #1) at the time of discovery.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years (annually for LTC).] At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop an Emergency Preparedness policy/Plan, that included the use of volunteers, as appropriate, and/or other emergency staffing strategies to address surge needs during the COVID-19 crisis, resulting in the potential for the interruption in needed care and services for staff and all 25 patients currently serviced by this agency. Findings included: A review the agency's Emergency Preparedness documents was conducted on 4/20/21 at 10:30 a.m. During the review, it was noted that there was no specific language that included a process for the integration or use of volunteers, as appropriate, or other staffing strategies with local, regional, State, and Federal officials to address surge needs during an emergency and the COVID-19 crisis. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 4/21/21 at 9:28 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 25 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 4/20/21 at 11:30 a.m., 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 the Administrator and the Clinical Manager at the time of discovery.

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, it was determined the Agency failed to provide initial training in emergency preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, and failed to maintain documentation of training's, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: On 4/21/21 at 9:00 a.m., The Agency's Administrator (Adm #1) was asked to provide evidence of initial training for all staff employed by the agency, and all contracted staff, yet was unable to do so. Adm #1 reported, We don't keep any files for our contracted staff." When asked if the agency provided Emergency Preparedness training to it's contracted staff, Adm #1 responded, "No." The Agency failed to provide initial and ongoing training in emergency preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, and failed to maintain documentation of training's. These findings were reviewed with and acknowledged by Adm #1 at the time of discovery.

EP Testing Requirements CFR(s): 484.102(d)(2) *[For RNCHI at §403.748, ASCs at §416.54, HHAs at §484.102, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHC at §485.920, RHC/FQHC at §491.12, 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 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 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. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to provide documentation for the required community/facility based full-scale exercises and failed to provide documentation of an actual event that would qualify as a test of the emergency plan, resulting in staff being ill-prepared in the event of an actual emergency. This deficient practice could negatively affect all 25 patients currently serviced by this Agency. Findings include: During review of the agency's Emergency Preparedness documents on 4/20/21, with the Administrator (Adm #1) and Clinical Manager (CM #1), it was noted that there was no evidence the agency had conducted any training or exercises to test the agencies emergency plan. There was no documentation of an actual event that would qualify as an emergency, no community based full-scale exercise, no second full-scale exercise or a table-top exercise. Adm #1 stated, "We did that." When asked to provide documentation, Adm #1 reported, "The Clinical Manager went to a meeting and brought back the information to share with us." The Agency failed to provide documented evidence that the required training's had been conducted. The above findings were reviewed with and confirmed by the Administrator (Adm #1) and the Clinical Manager (CM #1) at the time of discovery.

The following Condition and Standard level deficiencies were identified during an authorized Medicare Re-Certification survey, concurrent with a Focused Covid-19 Infection Control survey, conducted on 4/20/2021 through 4/23/2021 by the Michigan Department of Licensing and Regulatory Affairs at: Michigan Home Health Services 33730 Freedom Rd., Suite A Farmington Hills, MI 48335 At the time of the survey, the agency did not operate any branch locations. The services the agency provides are: Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW), Home Health Aide (HHa) and Speech Therapy (ST). Clinical records reviewed for this survey included: 3 records with home visits and 4 records without home visits, for a total of 7 records reviewed. Condition level deficiencies were identified at: 42 CFR §484.55 Comprehensive Assessment of Patients 42 CFR §484.65 Quality Assessment/Performance Improvement 42 CFR §484.80 Home Health Aide Services 42 CFR §484.102 Emergency Preparedness. 42 CFR §484.110 Clinical Records. 42 CFR §484.115 Personnel Qualifications. 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).

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure that 2 (MR's #1 and 2) of 3 patients observed during home visits, were included in the overall planning of care including the timeliness of services received; and failed to inform the patient/caregiver in advance of the days in which services would be provided resulting lack of inclusion in planning, the potential for missed visits and unmet care needs (G434); 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 2 (MR# 4, and 5) of 2 discharged records, resulting in the patient being denied the right to appeal the decision to end covered services (G442); failed to advise their patients of the names, addresses and telephone numbers of federally funded and state-funded entities that serve the area where the patient resides, resulting in the potential for unmet patient care needs for all 25 patients currently serviced by this agency (G446); and, failed to ensure that all drugs, care, and services were provided consistently in accordance with Physician's orders for 1 (MR #1) of 1 patient who required wound care, from a total of 7 records reviewed, resulting in the potential for physical decline, worsening of wounds and unmet care needs (G480). 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 §484.50 Patient Rights

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure that 2 (MR's #1 and 2) of 3 patients observed during home visits, were included in the overall planning of care including the timeliness of services received; and failed to inform the patient/caregiver in advance of the days in which services would be provided resulting lack of inclusion in planning, the potential for missed visits and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 3/20/21 with diagnoses that included stage II pressure ulcer bilateral buttocks, Hypertension and Alzheimer's Disease. During the clinical record review on 4/20/21 at 10:35 a.m., it was noted that Skilled Nursing (SN) and Physical Therapy (PT) services were ordered to provide care. On 4/20/21 at 1:00 p.m., a home visit was conducted by the Registered Nurse (RN #1). During a review of the patient's admission packet, it was noted that there was no calendar of proposed visits to be made by the RN or PT. It was further observed that the staff person (Staff #1) asked RN #1, more than once, "When will you be coming back to see him? (patient)" RN #1 had not provided the patient with a proposed visit schedule at the SOC. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/20/21 at 2:05 p.m. MR #2: The patient's SOC was 4/14/21 with diagnoses that included Right Knee replacement and COPD (chronic obstructive pulmonary disease). During the clinical record review on 4/21/21 at 9:15 a.m., it was noted that SN and PT services had been ordered to provide care. On 4/21/21 at 1:00 p.m., during a scheduled PT visit with PT #1, it was noted that the patient's admission packet was void of a calendar of proposed visits to be made by the SN and PT. During the visit, PT #1 stated, "I'll be back to see you on Saturday. Does that work for you?" The patient stated, "I'm not sure. Let me take a look." The patient checked his cell phone for any upcoming commitments and responded, "That should work." The agency failed to ensure a calendar of proposed visits had been provided at the SOC to assist the patient with participating in planning his care and daily routine. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/22/21 at 4:15 p.m.

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 2 (MR# 4, and 5) of 2 discharged records, resulting in the patient being denied the right to appeal the decision to end covered services. Findings include: MR #4: The patient's start of care (SOC) was 10/27/20 with diagnoses that included Hypertension, Osteoarthritis and COPD (Chronic Obstructive Pulmonary Disease). The record review, conducted on 4/22/21 at 10:30 a.m., revealed the following: The plan of care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT), Medical Social Work (MSW) services to be provided. The patient discharged from the agency's services on 11/27/20. There was no documented evidence that the patient was provided the "Notice of Medicare Provider Non-Coverage" prior to being discharged from the agency. The Agency failed to ensure the patient received proper written Notice of Medicare Provider Non-Coverage in advance of the agency terminating on-going care. MR #5: The patient's SOC was 12/15/21 with diagnoses that included Degenerative disc disorder, Stiff Right hand, Surgery left hand. The record review, conducted on 4/22/21 at 12:00 p.m., revealed the following: The POC ordered PT and Occupational Therapy (OT) services to be provided. The patient discharged from the agency's services on 12/31/20. There was no documented evidence that the patient was provided the "Notice of Medicare Provider Non-Coverage" prior to being discharged from the agency. The Agency failed to ensure the above discharged patients received proper written Notice of Medicare Provider Non-Coverage in advance of the agency terminating on-going care. The above findings were reviewed with and acknowledged by the Administrator (Adm #) and Clinical Manager (CM #1) during an interview on 4/22/21 at 4:51 p.m.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on record review and interview, it was noted that the Agency failed to advise their patients of the names, addresses and telephone numbers of federally funded and state-funded entities that serve the area where the patient resides, resulting in the potential for unmet patient care needs for all 25 patients currently serviced by this agency. Findings include: During a review of the Agency's patient admission packet on 4/20/21 at 11:20 a.m., it was noted that the information for the Federally and State funded patient resource entities (Agency on Aging, Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center and Quality Improvement Organization) had not been included. These findings were reviewed with the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/23/21 at 1:40 p.m.

Treatment or care CFR(s): 484.50(e)(1)(i)(A) (i)(A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; and This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that all drugs, care, and services were provided consistently in accordance with Physician's orders for 1 (MR #1) of 1 patient who required wound care, from a total of 7 records reviewed, resulting in the potential for physical decline, worsening of wounds and unmet care needs. Findings include: Policy: "Admission Policy" Rev. 7.13 stated, "Patients will be accepted for home care with the expectation that the Agency can provide the services the patient needs and that the patient's condition can be managed safely in the home care setting..., There is no agreement that the Agency will accept responsibility for the patient's care until a satisfactory comprehensive assessment is completed by agency staff." Policy: "Physician Role in Home Care of Patients/Plan of Care", Rev. 7.13 stated, "The Agency and its clinical staff work closely with the patient's attending and other physicians to provide comprehensive care that meets the patient's changing needs and promotes the highest level of health and independence..., the agency's Medical Director will be asked to intervene. It may be necessary to assist the patient in finding another attending physician/caregiver. MR #1: The patient's start of care (SOC) was 3/30/21 with diagnoses that included stage II pressure ulcer bilateral buttock, hypertension, and Alzheimer's disease. On 4/20/21 at 1:00 p.m., a joint home visit was conducted with the Registered Nurse (RN #1). The patient was observed sitting in a Gerry (brand name lift) chair. Further observations revealed the presence of stage II pressure sores to the patient's bilateral buttocks. During the visit, a review of the nursing progress notes revealed an entry dated 3/9/21 which documented, "Case opened, stage II decub (pressure sore) bil (bilateral) gluteal fold...PT (Physical Therapy) to be added." When queried about the entry RN #1 stated, "I opened his case on the 9th (3/9/21) and they (agency) had me reopen him on the 30th (3/30/21)." RN #1 was unable to explain why the patient's case was reopened. The next entry, dated 3/30/21, completed by RN #1 documented, "Case opened. Decub care..., PT to be added." On 4/20/21 at 2:28 p.m. during the clinical record review, it was noted that the referral for home care was dated 3/4/21 and ordered, "skilled nursing for wound care, new wound buttocks." The Initial Comprehensive Assessment, completed by the Registered Nurse, was dated 3/30/21, documented the presence of bilateral stage II pressure ulcers and requested that PT be added due to fall risk. There was no other documentation in the clinical record prior to 3/30/21 documenting any provision of care. On 4/22/21 at 3:42 p.m., an interview was conducted with the Administrator (Adm #1) and Clinical Manager (CM #). When queried about the status of the patient's admission, Adm #1 reported, "We completed the Comprehensive Assessment. The doctor's office called us and we were told that that doctor wasn't going to be with that Physician's group and they told us to stop, so we closed his (patient) case and I wiped out the whole record and we started from 3/30/21. I don't know what happened within the group." When asked if there was a Physician's order to discontinue care, Adm #1 replied, "No." When queried about the timeframe in which these events occurred, Adm #1 acknowledged that she did not document anything. Additional review revealed the original referral for home care that was dated 3/4/21, had a handwritten date of 3/29/21 (found to be that of agency office staff) located at the bottom border of the document. When asked if the agency had obtained a new order for Home Care services in light of the discontinuation of services, Adm #1 reported, "No, we didn't get a new order because we found out that this physician (current doctor) was from the same group." When asked if the agency consulted with the Medical Director, in accordance with the agency's policy, regarding continuity of care and services, Adm #1 reported, "No." There was no documented evidence that the agency provided any care for the patient from 3/9/21 to 3/30/21, or that the Medical Director was consulted for guidance.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status and events that lead to the need for home care, in 3 (MR# 2, 3, 4) of 7 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); failed to ensure the patient's Medical Social Work needs were adequately met in the patient's home for 1 (MR #4) of 1 who required assistance with meals; and failed to ensure the Activity of Daily Living needs were met in 1 (MR# 5) of 1 records in which the patient required assistance with self-care, resulting in the potential for psychological and nutritional decline, lack of resources, poor hygiene, and unmet care needs (G534); failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review, and failed to ensure the Physician was notified of potential drug interactions in 5 (MR#'s 3, 4, 5, 6 and 7) of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency (G536). 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 §484.55 Comprehensive Assessment of Patients.

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 and events that lead to the need for home care, in 3 (MR# 2, 3, 4) of 7 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: The patient's start of care (SOC) was 4/14/21 with diagnoses that included right knee replacement, hypertension, and COPD (chronic obstructive pulmonary disease). The clinical record review was conducted on 4/21/21 at 9:15 a.m. The Initial Comprehensive Assessment dated 4/14/21 completed by the Registered Nurse revealed the following: Section 1021/1023 listed diagnoses of hypertension, COPD, osteoarthritis, sleep apnea, insomnia, vitamin D deficiency and obesity. All the above diagnoses had an exacerbation date of 4/12/21 (2 days prior to admission to home care). 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 Clinical Manager (CM #1) during an interview on 4/22/21 at 4:15 p.m. MR #3: The patient's SOC was 3/26/21 with diagnoses that included revision of ORIF (open reduction internal fixation). The clinical record review was conducted on 4/21/21 at 10:00 a.m. The Initial Comprehensive Assessment dated 3/26/21 completed by the Physical Therapist revealed: Section 1021/1023 listed primary and other diagnoses of fractured femur, diabetes mellitus, asthma, hypertension, and diverticulosis. All the listed diagnoses had an exacerbation date of 3/24/21 (2 days prior to admission to home care). There was no history of the status of the above diseases including onsets, treatments for past medical history problems, outcomes from the treatments, and no documentation of the events that lead to the need for home care. These findings were reviewed with and acknowledged by Adm #1 and the Clinical Manager (CM #1) during an interview on 4/22/21 at 4:22 p.m. MR #4: The patient's SOC was 10/27/20 with diagnoses that included hypertension, osteoarthritis, and COPD. The clinical record review was conducted on 4/22/21 at 10:30 a.m. The Initial Comprehensive Assessment dated 10/27/20 completed by the Registered Nurse revealed: Section 1021/1023 listed primary and other diagnoses of hypertension, osteoarthritis, asthma, COPD, fibromyalgia, urinary incontinence, and unsteadiness on feet. All the listed diagnoses had an exacerbation date of 10/26/20. There was no documentation of the history of the status of the above diseases including onsets, treatments for past medical history problems, outcomes from the treatments, and no documentation of the events that lead to the need for home care. The findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 4/22/21 at 4:45 p.m.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to ensure the patient's Medical Social Work needs were adequately met in the patient's home for 1 (MR #4) of 1 who required assistance with meals; and failed to ensure the Activity of Daily Living needs were met in 1 (MR# 5) of 1 records in which the patient required assistance with self-care, resulting in the potential for psychological and nutritional decline, lack of resources, poor hygiene, and unmet care needs. Findings include: MR #4: The patient's start of care (SOC) was 10/27/20 with diagnoses that included hypertension, osteoarthritis, and COPD. The clinical record review was conducted on 4/22/21 at 10:30 a.m. The section of the Initial Comprehensive Assessment titled, "Community Agencies/Social Service Screening" documented, "MSW referral indicated for Long term plan, meals on wheels - Yes." During the record review it was noted that MSW saw the patient on 10/27/20 and discharged the patient on 11/12/20. There was no documentation in either visit note providing evidence that MSW addressed the patient's need for Meals on Wheels. These findings were reviewed with the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/22/21 at 4:30 p.m. During the interview, CM #1 replied, "An MSW should have been put in place." MR #5: The patient's SOC was 12/15/20 with diagnoses that included Rheumatoid Arthritis, degenerative disc disorder, stiff right hand, and surgery of left hand. During the record review on 4/22/21 at 12:00 p.m., it was noted that the Initial Comprehensive Assessment, completed by the Physical Therapist, documented, "Right hand surgery July 2020, Functional Limitations: contracture, endurance, pain and assistive device." Section M1100 Supportive Assistance stated, "Patient lives alone, "Occasional/short-term assistance, son helps." Section M1800 through M1845 Grooming, toileting hygiene, Bathing, dressing upper/Lower body documented, "Someone must help..." There was no documented evidence that Home Health Aide Services had been added or offered to provide assistance with Activities of Daily Living. These findings were reviewed with the Adm #1 and CM #1 during a joint interview on 4/22/21 at 4:45 p.m. CM #1 stated, "A Home Health Aide should have been offered."

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects; failed to document the findings of the drug regime review, and failed to ensure the Physician was notified of potential drug interactions in 5 (MR#'s 3, 4, 5, 6 and 7) of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency. Findings include: Policy: "Admission Policy", Rev. 7.13 stated, "Comprehensive assessment includes review of all current medications for potential contraindication, drug/food/herbal interactions and reactions, significant side effects, duplicate drug therapy, effectiveness and patient compliance." Policy: "Medication Administration", Rev. 7.13, stated, "Agency staff shall check all medications the patient is taking to identify and promptly report to the physician any significant side effects or contraindications..." MR #3: The patient's start of care (SOC) was 3/26/21 with diagnoses that included revision of ORIF (open reduction internal fixation). During the record review conducted on 4/21/21 at 10:00 a.m., it was noted that section M2001 of the Initial Comprehensive Assessment, completed by the Physical Therapist (PT) documented, "No issues found during the review. The patient's 16 prescribed medications were entered in "Drugs.com" (online pharmaceutical drug interaction checker) and revealed: 1 major drug to drug interaction; 18 moderate drug to drug interactions; 2 major drug to food interactions; and 4 moderate drug to food interactions. There was no indication that a drug review had been conducted to identify any untoward drug interactions or that the Physician had been notified accordingly. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/22/21 at 4:22 p.m. MR #4: The patient's SOC was 10/27/20 with diagnoses that included hypertension, osteoarthritis and COPD (chronic obstructive pulmonary disease). During the record review on 4/22/21 at 10:30 a.m., it was noted that section M2001 of the Initial Comprehensive Assessment dated 10/27/20, completed by the Registered Nurse (RN) documented, "Yes-issues found during review." There was no documentation of what issues were identified. The Patient Medication Record signed by the Registered Nurse documented, "Physician contacted regarding medication discrepancies: NA; Physician notified of severe medication interactions? NA." A Doctor's note dated 9/30/20 documented "Prescriptions given: Oxycodone 10/325 mg 1-tab po tid prn #60 no refills. This medication was not listed on the Patient Medication Record and not included in the drug review. There was no indication that a drug review, that included all the patient's medications, had been conducted to identify any untoward drug interactions or that the Physician had been notified of the findings. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/22/21 at 4:30 p.m. MR #5: The patient's SOC was 12/15/20 with diagnoses that included rheumatoid arthritis and degenerative disc disorder. During the record review on 4/22/21 at 12:00 p.m., it was noted that section M2001 of the Initial Comprehensive Assessment, dated 12/15/20, completed by the PT documented, "No issues found during review." The Patient Medication Record dated 12/15/20 documented "Physician notified of severe medication interactions? Yes; Please explain: MD aware of meds." The section of the form titled, "Nurse signature and Title" was digitally signed by the Physical Therapist. The patient's 13 prescribed medications were entered in Drugs.com and revealed: 7 major drug to drug interactions, 15 moderate drug to drug interactions, 1 major drug to food interaction, and 3 moderate drug to food interactions. There was no indication that a drug review had been conducted to identify any untoward drug interactions or that the Physician had been notified of the findings. These findings were reviewed with Adm #1 and CM #1 during an interview on 4/22/21 at 4:51 p.m. MR #6: The patient's SOC was 4/6/21 with diagnoses that included chronic kidney disease, urinary retention and end stage renal disease. During the record review on 4/22/21 at 2:30 p.m., it was noted that section M2001 of the Initial Comprehensive Assessment, dated 12/15/20, completed by the RN documented, "No issues found during review." The Patient Medication Record 4/6/21 documented, "Physician contacted regarding medication discrepancies: NA." The section titled, "Action taken and Physician notified of severe medication interactions? were left blank. The patients 8 prescribed medications entered in Drugs.com and revealed: 1 major drug to drug interaction; 5 moderate drug to drug interactions; 2 moderate drug to food interactions and 2 duplicate drugs. There was no indication that a drug review had been conducted to determine the presence of any adverse effects. These findings were acknowledged during an interview on 4/22/21 with CM #1 and Adm #1 at 4:57 p.m. MR #7: The patient's SOC was 4/16/21 with diagnoses that included diabetes mellitus and hypertension. During the record review on 4/22/21 at 3:05 p.m., it was noted that section M2001 of the Initial Comprehensive Assessment dated 4/16/21, completed by the RN documented, "Yes-issues found during review." There was no documentation of what issues were identified. Section M2003 documented, "Medication Follow Up: No." The patient's 8 prescribed drugs were entered in Drugs.com and revealed: 2 major drug to drug interactions; 5 moderate drug to drug interactions, 2 major drug to food interactions, and 2 moderate drug to food interactions. The nurse failed to document what findings were identified during the review and failed to ensure the Physician was notified. The findings were reviewed with and acknowledged by Adm #1 and CM #1 during an interview on 4/22/21 at 5:05 p.m.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that all drugs, care, and services were provided only in accordance with Physician's orders for 1 (MR #1) of 1 record with change of Physician coverage, from a total of 7 records reviewed, resulting in the potential for the provision of unsafe, unauthorized care and unmet care needs. Findings include: Policy: "Physician Role in Home Care of Patients/Plan of Care", Rev. 7.13 stated, "Patients must be under the care of a physician (MD or DO) or Podiatrist licensed by the State who signs orders for care..., Patient Care follows a written POC, established and periodically reviewed by a doctor of medicine, osteopathy, or podiatric [sic] medicine." MR #1: The patient's start of care (SOC) was 3/30/21 with diagnoses that included stage II pressure ulcer bilateral buttock, hypertension, and Alzheimer's disease. On 4/20/21 at 1:00 p.m., a joint home visit was conducted with the Registered Nurse (RN #1). During the visit, a review of the nursing progress notes revealed an entry dated 3/9/21. When queried about the entry date, RN #1 stated, "I opened his case on the 9th (3/9/21) and they (agency) had me reopen him on the 30th (3/30/21)." RN #1 was unable to explain why the patient's case was reopened. On 4/20/21 at 2:28 p.m. during the clinical record review, it was noted that the referral for home care was dated 3/4/21 and ordered skilled nursing for wound care. The Initial Comprehensive Assessment, completed by the Registered Nurse, was dated 3/30/21. There was no other documentation in the clinical record from 3/9/21 to 3/30/21. On 4/22/21 at 3:42 p.m., an interview was conducted with the Administrator (Adm #1) and Clinical Manager (CM #). When queried about the status of the patient's admission, Adm #1 reported, "The doctor's office called us and we were told that the doctor wasn't going to be with that group and they told us to stop, so we closed his (patient) case. I don't know what happened within the group. We reopened the patient's case on 3/30/21." When asked if there was a Physician's order to discontinue care, Adm #1 replied, "No." When asked if the agency had obtained a new order for Home Care services in light of the discontinuation of services, Adm #1 reported, "No, we didn't get a new order because we found out the Physician was from the same group. The Agency failed to ensure that all drugs, care, and services were provided only in accordance with Physician's orders.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to include contact information for the Home Health Agency's Clinical Manager in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed patient concerns. Findings include: On 4/20/21 at 11:20 a.m., the Agency's Admission packet was reviewed. The packet included a consent form, admission agreement, Beneficiary notice and patient rights and responsibilities forms and Emergency Preparedness documents. Upon review, it was noted that there was no contact information for the Agency's Clinical Manager. These findings were reviewed with and confirmed by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/23/21 at 12:30 p.m.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: This Condition of Participation has NOT been met. Based on interview and record review, it was determined the Agency failed to provide evidence of its efforts to measure, track and analyze its quality indicators in order to assess processes of care and services, resulting in the inability to determine the scope of services provided and the potential unmet care needs for all 25 patients currently serviced by this agency (G0642); failed to develop Performance Improvement activities, as part of the Agency's Quality Assessment Performance Improvement program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions, resulting in the potential for the rendering of substandard care and unmet care needs (G654); failed to develop a Quality Assessment Performance Improvement program that documented the annual quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2019 and 2020 calendar years, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance (G658); failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to negatively affect the quality of care to all 25 patients currently receiving services (G660). 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 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to provide evidence of its efforts to measure, track and analyze it's quality indicators in order to assess processes of care and services, resulting in the inability to determine the scope of services provided and the potential unmet care needs for all 25 patients currently serviced by this agency. Findings include: On 422/21 at 9:42 a.m., during an interview, the Administrator (Adm #1) and Clinical Manager (CM #1) were queried about the Agency's QAPI (Quality Assessment Performance Improvement) program. When asked to define the agency's QAPI program, Adm #1 responded, "It's quality assurance to see if there is anything lacking in performance and to determine how to improve." Upon review of the agency's QAPI data with Adm #1 and CM #1, it was noted that there was no data to review for the calendar years 2019 and 2020 that showed the agency's efforts to measure, track and analyze indicators in order to determine if care and services have been provided safely and appropriately. Adm #1 reported, "2019 and 2020 was tough." These findings were reviewed with and confirmed by Adm #1 and CM #1 at the time of discovery.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to develop Performance Improvement activities, as part of the Agency's Quality Assessment Performance Improvement program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: On 4/22/2021 at 9:42 a.m., during an interview, the Administrator (Adm #1) and Clinical Manager (CM #1) were queried about the Agency's QAPI (Quality Assessment Performance Improvement) program. When asked to review the agency's Performance Improvement Projects, CM #1 reported, "We used infections for 3 quarters which should an increase in UTI's (urinary tract infections) but we didn't document."

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to develop a Quality Assessment Performance Improvement program that documented the annual quality improvement projects, the reasons for conducting these projects with measurable progress achieved on these projects for the 2019 and 2020 calendar years, resulting in the Agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings include: On 4/22/21 at 9:42 a.m., during an interview, the Administrator (Adm #1) and Clinical Manager (CM #1) were queried about documentation of the Agency's QAPI (Quality Assessment Performance Improvement) program and Performance Improvement Projects, reasons for conducting the projects along with measurable progress achieved. Adm #1/CM #1 were unable to provide the requested data and stated, "We had several projects but we didn't document. 2019 and 2020 was rough."

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based record review and interview, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to negatively affect the quality of care to all 25 patients currently receiving services. Findings include: During an interview on 4/22/21 at 9:42 a.m. a request was made to review the agency's Quality Assessment Performance Improvement (QAPI) report and Governing Body meeting minutes for 2019 and 2020. Adm #1 presented documents that were titled "Meeting Minutes." The presented documents had no signatures of authentication. There was no way to conclusively determine if the agency's Governing Body's provided oversight of the QAPI program. These findings were reviewed with and acknowledged by Adm #1 and CM #1 at the time of discovery.

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 skilled nurse followed accepted Infection Control standards of practice during wound care for 1 (MR #1) of 1 patient observed during a home visit, who required wound care treatment, from a total sample of 7 sampled records reviewed, resulting in the potential for the development and spread of infection. Findings include: *Agency Policy: There was no policy available for review regarding the above deficiencies. MR #1: The patient's start of care (SOC) was 3/30/21 with diagnoses that included stage II pressure ulcers to bilateral buttocks, hypertension and Alzheimer's disease. On 4/20/21 at 1:00 p.m., a scheduled joint survey home visit (patient resided in a group home) was conducted with the Registered Nurse (RN #1). During the visit, the following observations were made: The group home staff person (Staff #1) assisted in placing the patient in an upright position, with the use of a Hoyer lift (patient transfer unit). As Staff #1 removed the patient's brief, it was noted that he had a bowel movement. Staff #1 stated, "I'll clean him (patient) up after you (RN #1) are done." RN #1 placed a disposable pad on the the patient's dresser then placed her work bag on the pad. RN #1 then retrieved a 4x4 gauze from her bag, entered the patient's bathroom and wet the gauze with soap and water using the bar of soap on the sink. RN #1 proceeded towards the patient and began to wipe the patient's wounds in and upward, downward and circular motion, from dirty to clean. RN #1 then turned the gauze over and wiped from the patient's anus upward and over the patient's wounds. RN #1 then used a second gauze, patted the wound and left it (wound) open to air. Upon completion of the visit, RN #1 was queried about the above observations and techniques used to clean the patient's wounds and responded, "I've just been doing this for so long. I just didn't think about it." These findings were reviewed with and acknowledged by the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/20/21 at 2:05 p.m. CM #1 responded, "That's unacceptable. the wound should be cleaned from clean to dirty."

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 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, and failed to develop a method of screening all field staff employed by this agency, and those granted clinical privileges, resulting in the potential development and spread of the Covid-19 infection between staff and the agency's 25 current patients. Findings include: On 4/20/21 at 2:20 p.m., the Administrator (Adm #1), and the Clinical Manager (CM #1) were queried about the process for the screening of office staff and the screening of field staff prior to the provision of care and both acknowledged that only visitors were screened upon entrance to the agency, and that there was no process in place for screening office staff or field staff prior to the provision of care. Adm #1 acknowledged there was no screening process in place for office or field staff at the time of discovery.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: This Condition of Participation has NOT been met. Based on record review and interview, it was determined the agency failed to ensure that the individuals who furnished Home Health Aide services on its behalf, met the competency evaluation requirements of this section by ensuring the subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section were evaluated by a Registered Nurse (RN), who observed the Aide's performance of the required tasks with a patient in 1 of 1 Home Health Aide records reviewed, resulting in the potential for the provision of substandard care and unmet care needs (G768); failed to ensure that 1 of 1 Home Health Aides employed by the Agency, received the required 12 hours of annual in-service training, resulting in the potential for the rendering of substandard care and unmet care needs (G774); failed to ensure the Home Health Aide provided care and services as ordered in the plan of care for 1 (MR #3) of 1 patient observed during an Aide home visit, from a total of 7 sampled records reviewed, resulting in the potential for the rendering of unsafe care and unmet needs (G800); and, failed to ensure the skilled discipline made an annual onsite observation visit at the patient's residence to observe the care being provided, for 1 of 1 Home Health Aide employed by the Agency, resulting in the potential for the provision of substandard care and unmet care needs (G812). 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 §484.80 Home Health Aide Services.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that the individuals who furnished Home Health Aide services on its behalf, met the competency evaluation requirements of this section by ensuring the subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section were evaluated by a Registered Nurse who observed the Aide's performance of the required tasks with a patient in 1 of 1 Home Health Aide personnel record reviewed, resulting in the potential for the provision of substandard care and unmet care needs Findings include: Policy: "Certified Home Health Aide", Rev.5.14, stated, "The competencies and skills of home health aides are assessed prior to assignment..., The observation may be in a patient's home or in a laboratory setting using volunteers, colleagues, etc. [sic], Mannequins are not used." On 4/21/21 at 10:30 a.m., a review of the Home Health Aide (HHa #1 ) personnel file revealed the following: HHa #1: Date of Hire was 1/25/20. The "Home Health Aide Skills Competency/Performance Evaluation" in HHa #1's personnel file revealed: Topics of Ambulation (crutches, walker, cane), Basic Infection Control, Bath (Bed bath, sponge/tub/shower, back rub, skin care), Bed Making (occupied, empty, turn patient), Bowel/Bladder Elimination (Toileting, measure and record output), Catheter Care, Care of convulsive patient, Care of Diabetic patient, Care of Prosthetic Devices, Dressing, Exercises, Hair Care, Take and Record vital Signs... were all documented as "Self Assessment" as reported by the Home Health Aide. There was no clear evidence that any of the above tasks were directly observed by a Registered Nurse and on an actual patient. These findings were reviewed with the Clinical Manager (CM #1) during an interview on 4/22/2021. When queried about the these findings, CM #1 reported, "I'm pretty sure I observed her. I can't remember. There was no documented evidence that a competency evaluation had been conducted by a Registered Nurse Prior to the provision of care

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure that 1 (HHa #1) of 1 Home Health Aide files reviewed, received the required 12 hours of annual in-service training, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: Agency Policy: There was no policy available that addressed the above deficiencies. On 4/21/21 at 10:30 a.m., a review of the Agency's Home Health Aide (HHa) personnel files revealed the following: HHa #1: Date of Hire (DOH) was 1/25/20. Upon review, a document titled, "Michigan Home Health Services Annual Mandatory In-Service" dated 9/18/20 was signed and dated by HHa #1. There was no content provided detailing the listed training's. The document listed topics to be covered in orientation such as, Confidentiality, HIPPA (Privacy law)..., Further, the document had not been signed by a Registered Nurse who provided oversight of the required in-services. These findings were reviewed with the Administrator (Adm #1) and the Clinical Manager (CM #1) during an interview on 4/22/21.

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, interview and record review, the Agency failed to ensure the Home Health Aide provided care and services as ordered in the plan of care for 1 (MR #3) of 1 patient observed during an Aide home visit, from a total of 7 sampled records reviewed, resulting in the potential for the rendering of unsafe care and unmet needs. Findings include: Policy: "Job Description - Certified Home Health Aide", Rev. 5.14, stated, "Performs all functions outlined in the Home Health Aide Assignment Sheet/Plan of Care." MR #3: The patient's start of care was 3/6/21 with diagnoses that included Revision of ORIF (Open Reduction Internal Fixation). The clinical record review was conducted on 4/21/21 at 10:00 a.m. and revealed the following: The plan of care (POC) ordered Physical Therapy (PT) and Home Health Aide (HHa) services at a frequency of 2x/wk. x 5 wks. The "Aide Care Plan" dated 3/26/21 indicated the following tasks were to be performed every visit: Vitals signs (blood pressure, pulse, respiration, temperature) with parameters to be reported to the Therapist of (Systolic BP >164; and Diastolic BP >90), assist with ambulation and transfers, make bed, assist to dress, shower. On 4/21/21 at 3:00 p.m., during a scheduled home visit with HHa #1, the following was observed: HHa #1 took the patient's blood pressure, pulse and temperature. The patient's blood pressure reading was 187/98. HHa #1 did not check the patient's respirations as ordered. HHa #1 then assisted the patient with a shower and getting dressed. HHa #1 used a blow dryer to dry patient's hair, applied mousse (foam used on hair), then applied an aerosol spray to the patient's hair. HHa #1 then applied lotion to patient's back and legs. Non of the above mentioned tasks were ordered in the Aide Care Plan. HHa #1 did not make nor offer to make the patient's bed as ordered, prior to leaving the patient's home. Upon completion of the visit, HHa #1 was interviewed regarding the above tasks and responded, "I just like to do that for my patients. I think it's important." When asked why she failed to make the patient's bed, HHa #1 offered no response. When queried as to why she didn't count the patient's respirations, HHa #1 reported, "I don't wear a watch." Additionally, there was no documented evidence that Hha #1 informed the Physical Therapist of the patient's elevated blood pressure by the end of the survey. HHa #1 failed to provide care and services as ordered in the plan of care. These findings were also reviewed with and acknowledged by the Clinical Manager (CM #1) during an interview on 4/21/21 at 4:00 p.m. who reported, "I'll have to do some education with her (HHa #1)."

Direct observation every 12 months CFR(s): 484.80(h)(1)(iii) A registered nurse or other appropriate skilled professional must make an annual on-site visit to the location where a patient is receiving care in order to observe and assess each aide while he or she is performing care. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the skilled discipline made an annual onsite observation visit at the patient's residence to observe the care being provided, by 1 (HHa #1) 1 Home Health Aide employed by this agency, who's file reviewed, resulting in the potential for the provision of substandard care and unmet care needs. Findings include: Policy: There was no policy made available that addressed the above deficiency. On 4/21/21 at 10:30 a.m., a review of the Home Health Aide (HHa) personnel file revealed the following: HHa #1: Date of Hire was 1/25/20. There was no documented evidence in HHa #1's personnel file that the skilled discipline made an annual onsite visit at the patient's place of residency to ensure adequate provision of care. These findings were reviewed with and confirmed by the Clinical Manager (CM #1) during an interview on 4/22/21 who reported, "No I didn't make an annual onsite visit."

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, resulting in the potential for interruption in continuity of care and unmet care needs. Findings include: On 4/20/21 at 10:30 a.m., during the entrance conference, the Administrator (Adm #1) was asked what services were currently provided by the agency and reported, "We offer Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW), Speech Therapy (ST), and Home Health Aide (HHa) services." When asked if they utilized contract personnel, Adm #1 said "Yes." When asked which services were provided by the contract agency, Adm #1 stated, "We contract PT, MSW, SN, PT, OT and ST." When asked to clarify which service was directly provided by the Agency, Adm #1 reported, "Home Health Aide." Upon further review, it was noted that the agency also contracts Home Health Aide services through Allied Nursing contract services. The agency failed to ensure that at least one qualifying service was provided directly by agency employees. These findings were discussed and acknowledged at the time of discovery.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: This Condition of Participation has NOT been met. Based on record review and interview, the Agency failed to ensure the transfer/discharge summaries were complete, provided the patient's current health status at the time of transfer/discharge, progress toward goals, and forwarded to the receiving facility and the Physician in 2 (MR#s 4 and 6), of 2 records in which the patient was discharged/transferred from the agency's services, from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs (G1022); and, failed to ensure that its clinical records were properly stored, secured and safeguarded against loss or unauthorized use, including 1 (MR #1) of 1 record that was discarded, from a total of 7 sample records reviewed, resulting in the potential for compromise of protected health information for all past and current patients serviced by the agency G1028). 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 §484.110 Clinical Records.

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 the transfer/discharge summaries were complete, provided the patient's current health status at the time of transfer/discharge, progress toward goals, and forwarded to the receiving facility and the Physician in 2 (MR#s 4 and 6), of 2 records in which the patient was discharged/transferred from the agency's services, from a total of 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: Policy: "Admission Policy" Rev. 7.13 stated, "Discharge Summary..., information in the Discharge Summary: Brief statement of patient problems, outcomes, summary of care provided while on agency service, status at discharge, continuing care needs, instructions and referrals given to the patient, reason for discharge, existence of an advance directive." "Transfer and Summary: The Agency contacts physician and the facility to which the patient is being transferred..., reason for transfer, diagnosis, brief history, physical and psychosocial status at time of transfer, summary of care provided and patient's response or progress toward goals..." MR #4: The patient's start of care) (SOC) was 10/27/20 with diagnoses that included hypertension, osteoarthritis and COPD (chronic obstructive pulmonary disease). The clinical record review was conducted on 4/22/21 at 10:30 a.m. The plan of care (POC) ordered Skilled Nursing (SN) to assess pain level, skin breakdown, oxygen saturation; Physical Therapy (PT) and Medical Social Work (MSW). The patient discharged from SN on 11/20/20. The SN discharge summary dated 11/20/20 provided no summary of care provided during the period of care or the status at the time of discharge. The summary documented, "Condition at Discharge - Current Status: Needs Assistance..., Physician notified of discharge summary availability..., Goals Not Met: Pain issues, fall risk addressing by PT." There was no referral indicated for the goals that were not met. Additionally, there was no evidence that the Discharge Summary had been sent to the Physician within 5 days of discharge. of which goals were met, or that the physician had been notified of the patients' status upon discharge from SN services. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manager (CM #1) during an interview on 4/22/21 at 4:40 p.m. MR #6: The patient's SOC was 4/6/21 with diagnoses that included chronic kidney disease, urinary retention and end stage renal disease. The POC ordered SN for urinary catheter care. During the clinical record review on 4/22/21 at 2:30 p.m., it was noted that the patient was transferred to an inpatient facility on 4/14/21. No transfer summary had been completed detailing the reason for the transfer or the status of the patient at th etime of the transfer. Further review of the record revealed the patient transferred to the hospital due to "shunt concerns." These findings were reviewed with and confirmed by Adm #1 and CM #1 during an interview on 4/22/21 at 5:05 p.m. to which CM #1 reported, "We'll have to look into this."

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 its clinical records were properly stored, secured and safeguarded against loss or unauthorized use, including 1 (MR #1) of 1 record that was discarded, from a total of 7 sample records reviewed, resulting in the potential for compromise of protected health information for all past and current patients serviced by the agency. Findings include: Policy: "Confidentiality and Storage Policies: Rev. 5.14, stated, "Confidentiality of all patient information must be maintained at all times. Records will be stored in a locked file or room when not in use." "Single Encounters or One Time Only Visits: Single encounters (when it is not expected that the patient will be admitted to service or that no subsequent visits will be made) will be recorded on a Progress Note, Communication Note or Assessment form." On 4/20/21 at 9:10 a.m., upon arrival and entrance into the Agency suite, patient files were observed on a desk in the reception area. Patient names were visible. A tour of the office area revealed the presence of patient's charts on desks in open boxes. The door knob to the room where charts were stored, did not have a lock on it and blue tape was wrapped around the knob. The Agency failed to ensure that the clinical records were safeguarded against loss or unauthorized use. During the tour, the Administrator (Adm #1) reported, "The files were left out overnight. Our biller takes them out when she is working on them." These findings were observed and confirmed by Adm #1 at the time of discovery. MR #1: The patient's start of care (SOC) was 3/30/21 with diagnoses that included stage II pressure ulcer bilateral buttock, hypertension and Alzheimer's disease. On 4/20/21 at 1:00 p.m., a joint home visit was conducted with the Registered Nurse (RN #1). The patient was observed sitting in a Gerry (brand name lift) chair. Further observations revealed the presence of stage II pressure sores to the patient's bilateral buttocks. During the visit, a review of the nursing progress notes revealed an entry dated 3/9/21 which documented, "Case opened, stage II decub (pressure sore) bil (bilateral) gluteal fold...PT (Physical Therapy) to be added." When queried about the entry RN #1 stated, "I opened his case on the 9th (3/9/21) and they (agency) had me reopen him on the 30th (3/30/21)." RN #1 was unable to explain why the patient's case was reopened. The next entry completed by RN #1 documented, "Case opened. Decub care..., PT to be added." On 4/20/21 at 2:28 p.m. during the clinical record review, it was noted that the referral for home care was dated 3/4/21 and ordered, "skilled nursing for wound care, new wound buttocks." The Initial Comprehensive Assessment, completed by the Registered Nurse, was dated 3/30/21, documented the presence of bilateral stage II pressure ulcers and requested that PT be added due to fall risk. There was no other documentation in the clinical record prior to 3/30/21. On 4/22/21 at 3:42 p.m., an interview was conducted with the Administrator (Adm #1) and Clinical Manager (CM #). When queried about the status of the patient's admission, Adm #1 reported, "The doctor's office called us and we were told that the doctor wasn't going to be with that group and they told us to stop, so we closed his (patient) case and I wiped out the whole record. I don't know what happened within the group." When asked about the Initial Comprehensive Assessment that was completed on 3/9/21, Adm #1 restated, "I wiped the whole record out. I didn't think to document anything because I knew I wasn't going to bill for the service." The agency failed to ensure that its clinical records were properly stored, secured and safeguarded against loss or unauthorized use, and failed to ensure the clinical record was not deleted from the patient's history of care.

Personnel qualifications CFR(s): 484.115 Condition of participation: Personnel qualifications. HHA staff are required to meet the following standards: This CONDITION is not met as evidenced by: This Condition of Participation has NOT been met. Based on interview, it was determined that the Agency failed to ensure that its 73 regularly utilized contracted personnel had documentation of licensure and other qualifications, prior to being granted clinical privileges resulting in the potential for the rendering of substandard care and services to all 25 patients currently serviced by this agency. Findings include: On 4/21/21 at 9:28 a.m., the Administrator (Adm #1) was asked for permission to review the personnel files for its contracted staff ( Physical Therapist, Occupational Therapist, Speech Therapist, Medical Social Work, Home Health Aide) that included evidence of Licensure and training's, to which she replied, "We don't keep employee files for any of our contracted staff." The agency failed to ensure all contracted staff granted clinical privileges were licensed to provide care and services. 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 §484.115 Personnel Qualifications.