Every finding on record at Diversified Home Health Care, Inc

An unannounced standard Emergency Preparedness survey was conducted on 7/29/24 through 8/1/24 by the Michigan Department of Licensing and Regulatory Affairs. During the survey, Diversified Home Health Care was found to be in compliance with the requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness.

An unannounced Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs from 7/29/24 to 8/1/24 at: Diversified Home Health Care 16250 Northland Drive, Suite 241 Southfield, MI 48075 The agency does not operate any branch locations. 5 discharged records were reviewed. The agency did not have any active patients at the time of the survey. 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.

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 based on past medical history and history of events leading to current home care needs in 2 (P-2, 3) of 5 records reviewed, resulting in incomplete and inaccurate clinical information to aide in determining the needs of the patient. Findings include: P-2: This 44-year-old patient was admitted to this agency on 10/26/23 with the diagnosis of left shoulder pain and stiffness. During record review on 7/30/24, it was noted on the Outcomes and Assessment Information Set (OASIS) dated 10/26/23 under “Prior Level of Functioning” (baseline prior to admission) that the patient was fully dependent on others for bed mobility, transfers, sitting and standing balance, and ambulation (walking). Upon further review of the OASIS form under current performance of the above functions, it stated the patient required stand by assist for all bed mobility, 25% assistance for transfers, and 50% assistance to ambulate 20 feet with a walker. This information is conflicting as it appears that the patient was functioning significantly better at the evaluation than how he was at his baseline and may not need home care services. The Administrator (Staff A) was questioned regarding this information during an interview on 7/31/24 at 2:00 PM. Staff A stated the patient “told them” that’s what his status was prior to admission, however, she acknowledged the information was conflicting and should have been clarified in the evaluation as it does not show a clear picture of the patient in order to set appropriate goals for treatment. Staff A acknowledged the findings. P-3: This 77-year-old patient was admitted to this agency on 8/28/21 with the diagnosis of a sacral decubitus ulcer (wound on the tailbone) and muscle weakness. During record review on 7/30/24, it was noted on the OASIS dated 8/28/21 that the patient “Lives alone around the clock.” The OASIS also noted under “Potential Risk for Infection Assessment” that the patient had an “absence of a capable caregiver” for a confounding factor that increased his risk for infection. Upon further review of the record, it was noted the physical therapy evaluation dated 9/8/21 stated the patient lived with “family” and had a “willing caregiver available.” It is unclear who the patient lived with according to the documentation, therefore, the comprehensive assessment does not show a clear picture of the patient. Staff A was questioned regarding this information during an interview on 7/31/24 at 2:00 PM. Staff A stated she remember it was a “confusing situation” with this patient and not knowing who he lived with. Staff A admitted the findings were conflicting and did not show a clear picture of the patient in order to set appropriate goals for treatment. Staff A acknowledged the findings. P-4: This 65-year-old patient was admitted to this agency on 2/17/22 with a primary diagnosis of right hip osteoarthritis. Secondary diagnoses included left hip pain and presence of a left artificial hip joint. According to the narrative on the physical therapy plan of care, the patient had surgery on 2/11/22 for a left total hip replacement (not right). Also, during record review on 7/30/24, it was noted the OASIS dated 2/17/22 stated "No" under question M1340, "Does the patient have a surgical wound?" Staff A was questioned regarding this information during an interview on 7/31/24 at 2:00 PM. Staff A stated she thought P-4 had pian in both hips and need the right hip replaced too, however, Staff A was unable to find evidence of this in the record. Staff A acknowledged the primary diagnosis should have been noted as the left hip since that is what she was referred for following surgery. Staff A did not know why "No" was selected under surgical wound and acknowledged the findings.

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 clinicians included a review of all medications during the comprehensive assessment in order to identify any potential adverse effects and drug reactions in 1 (P-5) of 5 sample records reviewed potentially resulting in unknown side effects, drug interactions, duplication of therapies, and poor patient outcomes. Findings include: Agency policy titled “Medication Reconciliation”, Revised February 2024, was reviewed on 7/31/24. On page 1., it stated “The Agency will reconcile patient’s medications at the time of admission and on an ongoing basis in order to identify any potential adverse effects and drug reactions including ineffective drug therapy, significant side effects, significant drug reactions, duplicate drug therapy… Any concerns or discrepancies will be reconciled by a RN with the patient’s physician/practitioner… Discrepancies include duplications, omissions, changes, contraindicated or unclear information…” [sic]. P-5: This 71-year-old was admitted to the agency on 1/22/22 with diagnoses including recent left knee replacement surgery; osteoarthritis of left knee; and unspecified pain. The medical record was reviewed on 7/31/24. During review, it was noted that the comprehensive assessment was completed by the nurse on 1/22/22 and included documentation in the section “(M2001) Drug Regimen Review” indicating that a complete drug regimen review to identify potentially clinically significant medication issues was completed and no issues were found. During review of the patient medications, it was noted that the patient’s medication list contained duplications of two nonsteroidal anti-inflammatory pain relief medications (Meloxicam and Aspirin), and three additional medications for pain (Oxycodone, Tramadol, and Acetaminophen). During interview with the Administrator (Staff A) on 7/31/24 at 3:41 p.m., Staff A stated that the agency prints the medication interactions and duplications, reviews any discrepancies with the physician, and a copy is left in the medical record. Staff A stated that she recalled duplications with the medication list for this patient but was unable to locate the report in the medical record or show evidence that duplicate therapies were reconciled with the patient’s physician.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included individualized, patient-specific measurable outcomes and goals in 3 (P-1, 3, 5) of 5 sample records reviewed potentially resulting in the lack of care that is specific to the patient’s individual needs and difficulty determining progress toward goals for care. Findings include: P-1: This 68-year-old patient was admitted to this agency on 3/12/24 with the diagnosis of an encounter for surgical aftercare following surgery on the digestive system (wound care for non-healing surgical wounds on his abdomen). During record review on 7/30/24, it was determined the plan of care (dated 3/12/24) did not contain any measurable, objective goals regarding wound size and healing. P-3: This 77-year-old patient was admitted to this agency on 8/28/21 with the diagnosis of a sacral decubitus ulcer (wound on the tailbone) and muscle weakness. During record review on 7/30/24, it was determined the plan of care (dated 8/28/21) did not contain any measurable, objective goals regarding wound size or healing. The Administrator (Staff A) acknowledged the finding during an interview on 7/30/24 at 2:00 PM. P-5: This 71-year-old was admitted to the agency on 1/22/22 with diagnoses including recent left knee replacement surgery; osteoarthritis of left knee; and unspecified pain. The medical record was reviewed on 7/31/24. During review of the plan of care dated 1/22/22, the following examples of Skilled Nursing goals for care were noted: Patient will achieve optimal wound healing without further signs/symptoms of infection or complications by end of episode; Patient will have optimal bowel evacuation throughout episode of care; Patient/caregiver will be able to verbalize signs of type of infection to report and demonstrate proper infection precautions by 2/10/22. It was unclear how these goals were specific to this patient or how they would be measured in terms that would enable nursing staff to accurately perform an objective evaluation of the patient’s progress toward the goals. This finding was reviewed and acknowledged on 8/1/24 during interview at 12:15 p.m. with the Administrator, Staff A.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical records contained an accurate representation of all treatments and interventions provided in 2 (P-3 and P-5) of 5 records reviewed, resulting in the potential for an unclear picture of the patient’s treatment and an incomplete medical record. Findings include: P-5: This 71-year-old was admitted to the agency on 1/22/22 with diagnoses including recent left knee replacement surgery; osteoarthritis of left knee; and unspecified pain. The medical record was reviewed on 7/31/24. During review of the physician referral dated 1/19/22, it was noted that the patient had a “silver surgical knee dressing” on the left knee that was to remain in place until removed by the physician on 1/26/22 and, had a pain pump to be removed by the patient within “3-4 days” after surgery. During review of the comprehensive assessment dated 1/22/22, it was noted that the Registered Nurse (RN) documented under the section “Pain Status”, that the patient had a “pain pump” inserted in the left upper thigh and that the patient would be removing the pain pump per physician orders on the scheduled date of 1/23/22. The following was noted when reviewing the RN visit notes: there was no RN visit on 1/23/22. The RN visit on 1/24/22 did not include documentation of whether the pain pump in the upper left thigh had been removed, what the patient’s response to the removal of the pain pump was, or the condition of the skin to the left upper thigh after removal. It was unclear from the RN documentation if the patient removed the pain pump as ordered. Also during review of the comprehensive assessment dated 1/22/22, the RN documented under the section “Wound Care Flowsheet”, that the first dressing change to the left knee would be completed by the provider. During review of the plan of care dated 1/22/22, a skilled nursing physician order was included and stated, “Per physician orders, care of incision is as follows: Remove dressing on 1/26/2022.” The following was noted when reviewing the RN visit notes: the RN did not make a visit on 1/26/22. On 1/27/22, the RN made a visit and did not document if removal of the silver surgical dressing to the left knee had been completed and did not have any updated wound orders (if it had not been completed). It was unclear whether the silver surgical dressing to the left knee was removed as ordered. These findings were reviewed and acknowledged on 8/1/24 during interview at 12:15 p.m. with the Administrator, Staff A. Staff A agreed that treatments, services, and responses to interventions regarding the pain pump and the silver surgical left knee dressing were not documented in the medical record. P-3: This 77-year-old patient was admitted to this agency on 8/28/21 with the diagnosis of a sacral decubitus ulcer (wound on the tailbone) and muscle weakness. On 7/30/24, the treatment period from 8/28/21 to 10/26/21 was reviewed. Upon review of the skilled nursing notes for the wound care, it was determined that 14 of 17 skilled nursing daily notes (dated 9/7/21, 9/9/21, 9/11/21, 9/14/21, 9/16/21, 9/21/21, 9/25/21, 9/27/21, 9/29/21, 10/5/21, 10/15/21, 10/18/21, 10/21/21, and 10/25/21) had the following documented in the section under “Response to Care/Progress Toward Goals/Plan for Next Visit”: “Patient verbalized understanding of instruction on turning q2 to 3 hours and weight shifting q2-3 hours while sitting o prevent pressure on sacral area. Patient verbalized understanding of SN instruction to remind Dialysis technician to change his Dialysis port dressing as per protocol. Pt verbalized understanding when to call SN or PCP with S&S of infection and pain greater than 7/10 Pt verbalized understanding of the reason he in on Clindamycin 100 mg for prophylaxis to prevent infection and the need to stop use of mineral, iron while taking this medication without physician prescribed” [sic] The Administrator (Staff A) was queried regarding the identical documentation in 14 notes during an interview on 7/31/24 at 2:00 PM. Staff A stated that part carries through from the previous note and was not changed on the dates in questions. Staff A acknowledged the findings.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a completed discharge summary was sent to the primary care physician or other health care professional who will be responsible for providing care to the patient after discharge in 1 (P-3) of 5 discharged records reviewed, resulting in a lack of information communicated to ensure continuity of care for all patient’s discharged from this agency. Findings include: **Policy titled “Discharge Summary” (revised February 2024) stated, “2. A Discharge Summary will be sent within 5 business days of patient discharge to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient.” P-3: This 77-year-old patient was admitted to this agency on 8/28/21 with the diagnosis of a sacral decubitus ulcer (wound on the tailbone) and muscle weakness. During record review on 7/30/24, it was determined the discharge summary was written on 12/23/21. According to the fax confirmation sheet, the discharge summary was not sent to the doctor until 1/15/22 – 23 day after the discharge summary was written. The Administrator (Staff A) was unable to provide evidence of a fax sent informing the doctor of the discharge prior to this date and acknowledged the findings during an interview on 7/31/24 at 2:00 PM.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all entries into the clinical record were appropriately authenticated by the clinician who signed the entry in 1 (P-5) of 5 sample records reviewed resulting in duplicate assessment entries and potentially inaccurate patient information. Findings include: P-5: This 71-year-old was admitted to the agency on 1/22/22 with diagnoses including recent left knee replacement surgery; osteoarthritis of left knee; and unspecified pain. The medical record was reviewed on 7/31/24. During review, the following documentation, including all grammatical and spelling errors, was found in both the comprehensive assessment under section “Musculoskeletal Assessment” signed by the RN on 1/22/22 and in the PT evaluation under section “Assessment” signed by the PT on 1/27/22: “Patient was discharged from the hospital on the same day (01/19/2022). Patient has has increase in pain level to 7/10 on Left Knee follwoing surgery. Patient is allowed to put weight as tolerated on left L/E. Patient presents with impaired balance and coordination in standing due to weakness of Quadriceps, Hip Flexors, Hip Abductor and stiffness of back extensors muscles. Pain and stiffness in Left Knee causes difficulty in walking and standing up for extended period of time and performing ADLs. Patient is complaining of increase pain level and tiredness while walking and performing any activity. Patient has low endurance level and unsteady gait pattern with discontinuous steps and unequal weight bearing on B-Feet. Patient has decreased hip and Knee Flexion/Extension and decreased ground clearance. Patient has acquired kyphotic posture with rounded shoulders, and generalized muscle weakness affecting B-U/E and B-L/E and is at high risk for falls. Patient requires assistance in performing ADLs and IADLs. Patient lives with her friends in single family house and receives assistance from her friends. Patient requires to ambulate for 150 feet independently to get around in the house.” [sic]. During interview with the Administrator (Staff A) on 8/1/24 at 12:15 p.m., Staff A was queried to how both assessments could have the exact same information considering the assessments were signed by different staff members 5 days apart. Staff A stated that some assessment data provided by the referral source during the agency intake process was being auto populated on the comprehensive assessment to show need for home care. Staff A was queried to where this data was being auto populated on the comprehensive assessment and PT evaluation. Staff A stated that the data should only be auto populated in demographic areas, not in assessment areas. Staff A was queried to whether the assessment information was gathered by the agency clinician who signed the assessments (RN on 1/22/22 and PT on 1/27/22), or from the facility in which the patient was received (prior to admission to the home care agency), Staff A was not able to provide the answer.

The following Condition level defciencies were identified at an Emergency Preparedness re-certificaiton survey conducted by the Michigan Department of Licensing and Regulatory Affairs on 7/13/21 through 7/16/21 at: Diversified Home Health Care Inc. 16250 Northland Dr. Ste 241 Southfield, MI 48075 At the conclusion of the survey, this agency was determined to be non-compliant with the requirements for the Condition of Participation at: CFR §484.102 Emergency Preparedness.

Establishment of the Emergency Program (EP) CFR(s): 484.102 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the Agency failed to develop an emergency preparedness plan that must be reviewed, 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 4 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 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 staff and the 4 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, as appropriate, and failed to maintain documentation of trainings, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services (E0037); 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 and the potential for poor patient outcomes. This deficient practice could negatively affect all staff employed, and the 4 active 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 4 patients actively serviced by this Agency in the event of a facility emergency or disaster. Findings include: On 7/13/21 at 10:30 a.m., the Administrator (Adm #1) was asked for permission to review the agency's Emergency Preparedness documentation. 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. During a subsequent interview on 7/13/21 at 12:30 p.m., Adm #1 reported, "I can't find the documents. I had them in a binder."

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 7/13/21 at 10:50 a.m., the agency's Emergency Preparedness documents were reviewed with the Administrator (Adm #1) present. The Risk Assessment document was noted to be blank. During the review, Adm #1 searched for "additional binders and documents" then reported, "I can't locate the documents. I hired a clerical assistant who was to print up some documents but I don't see that it was done." These findings were reviewed with and confirmed by the Administrator (Adm #1) at the time of discovery.

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 staff and the 4 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 7/13/21 at 11:50 a.m., with the Administrator (Adm #1) present, 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 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, as appropriate, and failed to maintain documentation of trainings, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: On 7/13/21 at 10:50 a.m., The Agency's Administrator (Adm #1) was asked to provide documented 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 provide training for the contract staff, their agency trains them and they (contracted staff) complete the Emergency Preparedness Assessment in the patient's home." The Agency failed to provide initial and ongoing training based on Emergency Preparedness policies, procedures and risk Assessment, to all new and existing staff, including contract employees and volunteers, and failed to maintain documentation of trainings. 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 and the potential for poor patient outcomes. This deficient practice could negatively affect all staff employed, and the 4 active patients currently serviced by this Agency. Findings include: During review of the agency's Emergency Preparedness documents on 7/13/21 at 10:50 a.m., with the Administrator (Adm #1) present, it was noted that there was no evidence the agency had conducted any training or exercises to test the agencies emergency plan. Further, 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. The above findings were reviewed with and confirmed by the Administrator at the time of discovery.

The following Condition and Standard level deficiencies were identified at an authorized Medicare recertification survey conducted by the Michigan Department of Licensing and Regulatory Affairs on 7/13/2021 through 7/16/2021 at: Diversified Home Health Care Inc. 16250 Northland Dr. Ste 241 Southfield, MI 48075 This agency had no additional branch sites. Records reviewed: 2 records with home visits, 5 records without home visits, for a total of 7 records reivewed. (Only 2 of the 3 required home visits were made due to patient refusal.) At the conclusion of the survey the agency was found to be non-compliant for the Conditions of Participation for Home Health Agencies at: 42 CFR Part §484. The following Conditions were identified at: 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI). 42 CFR§484.80 Home Health Aide Services 42 CFR §485.102 Emergency Preparedness. 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).

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to include full contact information for the Home Health Agency's Administrator in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed patient concerns. Findings include: On 7/13/21 at 9:45 a.m., the Agency's Admission packet was reviewed. The packet included a consent form, admission agreement, Beneficiary notice, patient rights and responsibilities forms and Emergency Preparedness documents. Upon review, it was noted that there was no full contact information for the Agency's Administrator. These findings were reviewed with and confirmed by the Administrator (Adm #1) during an interview on 7/15/21 at 1:13 p.m.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status at the time of admission, including the events that led to the need for home care referral, for 7 (MR's #1, 2, 3, 4, 5, 6, and 7) of 7 records reviewed, resulting in incomplete clinical information in determining the needs of patients. Findings include: MR #1-7: During the clinical record review of the above-mentioned records from dates including 7/13/21 through 7/15/21, it was noted that sections M1021 and M1023 (Primary and Other diagnoses) of the Initial Comprehensive Assessment, failed to include dates of onset or exacerbation, status or resolution of identified diagnoses and the events that led to the need for home care referral. Additionally, the pain parameters were set to report pain greater than "100/10" (sic). These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 7/15/21 at 12:02 p.m. who reported, "I don't know why pain parameters would be set to report if pain is greater than 100. That must have been an error."

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, failed to ensure the Physician was notified of potential drug interactions as appropriate, and failed to ensure the Registered Nurse provided oversight of the drug review process conducted by the Physical therapist in 5 (MR's # 1, 2, 3 4 and 5) of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all 4 patients currently serviced by this Agency. Findings include: MR #1: The patient's start of care (SOC) was 6/7/21 with diagnoses that included Osteoarthritis, lumbago and sciatica. On 7/13/21 at 11:15 a.m., during a review of the clinical record, section M2001 of the Initial Comprehensive Assessment/Oasis dated 6/7/21, completed by the Physical Therapist (PT) indicated "No issues found during review." It was noted that the review had not been reviewed by a Registered Nurse as per this requirement. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 7/15/21 at 12:02 p.m. MR #2: The patient's SOC was 6/26/21 with diagnoses that included COPD, PVD, quadriplegia and HIV. On 7/13/21 at 12:05 p.m., during a review of the clinical record, section M2001 of the Initial Comprehensive Assessment/Oasis dated 6/26/21, completed by the Registered Nurse (RN) indicated "No issues found during review." The patient's 8 prescribed medications were entered in "Drugs.com (online drug interaction checker) and revealed 3 moderate drug to drug interactions, 4 drug to food interactions and 1 duplicate drug. There was no documented evidence that a drug review had been conducted. These findings were reviewed with and confirmed by Adm #1 during an interview on 7/15/21 at 12:08 p.m. MR #3: The patient's SOC was 7/2/21 with diagnoses that included CHF, DM, and pressure sores. On 7/13/21 at 1:28 p.m., during a review of the clinical record, it was noted that section M2001 of the Initial Comprehensive Assessment/Oasis dated 7/2/21, completed by the RN indicated "Yes - issues found during review." There was no documented evidence of what issues had been identified or that the Physician had been notified of the findings as appropriate. Additionally, during a joint survey home visit with the Home Health Aide (HHa #1) on 7/14/21 at 8:30 a.m., there was no Medication Profile that lists all the patients medications, frequency and side effects, left in the patient's home. These findings were reviewed with and acknowledged by Adm #1 during an interview on 7/15/21 at 12:20 p.m. MR #4: The patient's SOC was 6/25/21 with diagnoses that included Cerebellar ataxia and chronic pain syndrome. On 7/13/21 at 3:05 p.m., during a review of the clinical record, it was noted that section M2001 of the Initial Comprehensive Assessment/Oasis dated 6/25/21, completed by the RN indicated "Yes - issues found during review." There was no documented evidence of what issues had been identified or that the Physician had been notified of the findings as appropriate. Additionally, during a joint survey home visit with the Physical Therapist (PT #1) on 7/14/21 at 2:00 p.m., there was no Medication Profile that lists all the patients medications, frequency and side effects, left in the patient's home. These findings were reviewed with and acknowledged by Adm #1 during an interview on 7/15/21 at 12:35 p.m. MR #5: The patient's SOC was 4/12/21 with diagnoses that included Multiple myeloma, depression and DM. On 7/15/21 at 11:40 a.m., during the clinical record review, it was noted that the patient transferred to an inpatient facility on 4/18/21 and resumed agency services on 4/27/21. There was no documented evidence that a drug review had been conducted at the Resumption of Care (ROC) as per this requirement. These findings were reviewed with and confirmed by Adm #1 during an interview on 7/16/21 at 12:30 p.m.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the plan of care included all pertinent interventions with reportable parameters, safety precautions and objectively measurable goals specific to the needs of the patient for 3 (MR's # 1, 2 and 4) records, from a total of 7 sampled records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes. Findings include: MR #1: The patient's SOC was 6/7/21 with diagnoses that included Osteoarthritis, lumbago and sciatica. During the clinical record review on 7/13/21 at 11:15 a.m., it was noted that the POC failed to include pain parameters ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The POC was was void of any measurable dates in which specified goals would be met. These findings were reviewed with and confirmed by the Administrator (Adm #1) during an interivew on 7/15/21 at 12:02 p.m. MR #2: The patient's SOC was 6/26/21 with diagnoses that included COPD, PVD and HIV. During the record review on 7/13/21 at 12:05 p.m., it was noted that the patient reported a pain level of 4/10 at the SOC. The POC had pain parameters set to notify the Physician for pain greater than 10. Further review revealed the patient had a feeding tube, however, there were no interventions or parameters noted on the POC. Additionally, the goals did not include any dates in which the goals would be attained. These findings were reviewed with and acknowledged by Adm #1 during an interview on 7/15/21 at 12:08 p.m. MR #4: The patient's SOC was 6/25/21 with diagnoses that included Cerebellar ataxia and chronic pain syndrome. During the record review on 7/13/21 at 3:05 p.m., it was noted that the sections of the POC titled "Safety", and "Caregiver Status" were left blank. The POC documented, "Notify Physician of vital sign parameters out of range: Pain Level: Greater than 100."(sic). Additionally, there were no specified dates in which goals would be attained. These findings were reviewed with Adm #1 during an interview on 7/15/21 at 12:35 p.m. who offered no response.

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 7/13/21 at 9:45 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) during an interview on 7/15/21 at 1:13 p.m.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on 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 and show measurable improvement, 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 4 patients currently serviced by this agency (G642); 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 services, 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 2021 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 4 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 and show measurable improvement, 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 4 patients currently serviced by this agency. Findings include: On 7/15/21 at 10:32 a.m., the Administrator (Adm #1) was asked for permission to review the Agency's QAPI (Quality Assessment Performance Improvement) program data. Adm #1 provided a binder titled, "QAPI, (Quality Assessment and Performance Improvement." Upon review, the binder contained a total of 4 documents: A Policy and 3 documents titled "Annual Analysis/Assessment of Leader's Effectiveness of contributions to Quality Assessment and Performance Improvement (QAPI) and Safety Improvement Activities." The documents listed 7 objectives such as, "safety, human resources, time for staff to participate in QAPI project, analyzing data, staff training , national reference database, and data and information used effectively..." One of the documents (master copy), was blank and the other 2 were copies of the same. There was no data made available for review. These findings were reviewed with and confirmed by Adm #1 at the time of discovery who reported, "It's been a challenge. Persons I had overseeing certain projects weren't actually doing anything."

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 services, and unmet care needs. Findings include: On 7/15/2021 at 10:32 a.m., during an interview, the Administrator (Adm #1) was queried about the Agency's QAPI (Quality Assessment Performance Improvement) program. When asked to review the agency's Performance Improvement Projects, Adm #1 reported, "I have so much going on. I need to spend more time focusing on this agency." Adm #1 submitted a binder titled, "QAPI." There was no data available for review. These findings were reviewed with and acknowledged by Adm #1 at the time of discovery.

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 annual quality improvement projects, the reasons for conducting these projects with measurable progress achieved for the 2019 and 2021 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 7/15/21 at 10:32 a.m., during an interview, the Administrator (Adm #1) was 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 was unable to provide the requested data and stated, "It's been a challenge. The persons I had overseeing certain projects weren't actually doing anything." Adm #1 was unable to provide the requested documented evidence in accordance with this requirement. These findings were reviewed with and acknowledged by Adm #1 at the time of discovery.

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, patient safety and was evaluated for effectiveness, resulting in the potential to negatively affect the quality of care to all 4 patients currently receiving services. Findings include: During an interview on 7/15/21 at 10:32 a.m. a request was made to review the agency's Quality Assessment Performance Improvement (QAPI) report and Governing Body meeting minutes for 2018, 2019 and 2020. Adm #1 presented a binder titled "QAPI." The QAPI binder was empty. There was no data available for review. Adm #1 presented a separate binder titled "Governing Body." The binder contained Governing body Meeting Minutes dated November 2019. Topics were discussions of "State Survey, recruitment and marketing and relationship with Physicians..." There was no discussion of the agency's QAPI program. There was no documented evidence that the Governing Body provided oversight of the agency's QAPI program. These findings were reviewed with and acknowledged by Adm #1 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: 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 2 of 2 Home Health Aide personnel records reviewed, resulting in the potential for the provision of substandard care and unmet care needs (G768); failed to ensure that 2 of 2 Home Health Aides, whose personnel files were 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 (G774); failed to ensure Skilled Nursing and Physical Therapy prepared clear written patient care instructions for the home health aide regarding client needs, and safety precautions prior to the provision of care in 2 (MR#'s 2 and 3) of 4 records in which Home Health Aide services were ordered, from a total of 7 sampled records reviewed, resulting in the potential for the provision of unsafe care and unmet care needs (G798); 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); 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 of 2 Home Health Aides employed by this agency, whose file was reviewed, resulting in the potential for the provision of substandard care and unmet care needs (G812);

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 2 of 2 Home Health Aide personnel records reviewed, resulting in the potential for the provision of substandard care and unmet care needs. Findings include: Policy: "Home Health Aide Services and Training Program" stated, "All Home Health Aides employed or contracted by the Agency will satisfactorily complete a home health aide training program and competency evaluation program prior to performing patient care." On 7/15/21 at 9:26 a.m., a review of the Home Health Aide (HHa #1) personnel file revealed the following: HHa #1: Date of Hire was 6/28/21. The "Initial On-Site Competency Checklist" in HHa #1's personnel file revealed: Topics such as: Bath (Bed bath, sponge/tub/shower, shampoo; sink, tub and bed, Oral hygiene, toileting and elimination, Fluid intake and adequate nutrition, Nail and skin care.." All the above tasks were dated for 6/28/21 (HHa #1's date of hire). The section titled "T.P.R., BP: reading and recording", was left blank. The sections titled, "Observed in home with a patient, and Observed on a pseudo-patient in an appropriate environment, were both left blank. The section to document if the Aide was competent, Yes/No, was only initialed by HHa #1. The section titled, "Home Health Aide Demonstrated competency to Provide Care" was also left blank. There was no documented evidence that a competency evaluation had been conducted by a Registered Nurse Prior to the provision of care. HHa #2: Date of Hire was 11/3/2011. There was no documentation of a competency evaluation available for review in Hha #2's personnel file. The above findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 7/16/21 at 12:00 p.m.

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 2 of 2 Home Health Aides, whose personnel files were 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: "Home Health Aide Services and Training Program", stated "A home health aide must receive at least 12 hours of in-service training during each 12-month period." 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 6/28/21. There was no in-service data available for review. HHa #2 DOH was 11/3/11. There was no in-service data available for review. These findings were reviewed with the Administrator (Adm #1) during an interview on 7/16/21.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure Skilled Nursing and Physical Therapy prepared clear written patient care instructions for the home health aide regarding client needs, and safety precautions prior to the provision of care in 2 (MR#'s 2 and 3) of 4 records in which Home Health Aide services were ordered, from a total of 7 sampled records reviewed, resulting in the potential for the provision of unsafe care and unmet care needs. Findings include: Policy: "Home Health Aide Services and Training Program" stated, "Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional." MR #2: The patient's start of care (SOC) was 6/26/21 with diagnoses that included COPD (chronic obstructive pulmonary disease), PVD and HIV. The 485/plan of care (POC) indicated the following: "Bladder incontinence, vision deficit; Safety: aspiration precautions, bleeding precautions, fall precautions, proper positioning during meals, side rails up, seizure precaution..." The "HHA Care Plan" dated 6/26/21 failed to provide specific instruction/guidance related to the patient's feeding tube. These findings were reviewed with the Administrator (Adm #1) during an interview on 7/15/21 at 12:08 p.m. MR #3: The patient's SOC was 7/2/21 with diagnoses that included CHF, DM, O2 dependency and pressure sores. The POC indicated the following: "Bladder incontinence, vision deficit, bleeding precautions, Elevate head of bed..." The HHA Care Plan dated 7/2/21 did not include bleeding precautions and failed to include instructions/guidance regarding measures to take regarding the patient's wounds and measures to take in the event the patient's wound dressings become soiled or removed during care. These findings were reviewed with Adm #1 during an interview on 7/15/21 at 12:20 p.m.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, 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 patients 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: Home Health Aide Services and Training Program, stated "A home health aide provides services that are: Ordered by the physician, Included in the plan of care, Permitted to be performed under state law, Consistent with the home health aide training." MR #3: The patient's start of care (SOC) was 7/2/21 with diagnoses that included Congestive Heart Failure, diabetes mellitus and pressure sores. During the record review on 7/13/21 at 1:28 p.m., it was noted that the plan of care (POC) ordered Skilled Nursing (SN) and Home Health Aide (HHa) services to be provided. The "HHa (Aide) Care Plan" dated 7/2/21 ordered the following tasks to be completed "QV" (every visit): Temperature, Bed Bath, Hair Care/Comb Hair, Oral Care, Pericare, Medication Reminder, Change Linen, Light Housekeeping, Range of Motion..." On 7/14/21 at 8:30 a.m., a survey home visit was conducted with HHa #1. During the visit, HHa #1 performed a bed bath, rinsed the patient's dentures in denture cleaner, and proceeded to change the patient's brief. Of the ordered tasks, HHa #1 did not take the patient's temperature, perform hair care, change the patient's linen, or provide oral care. During the bath, HHa #1 did not clean the patient's feet or vagina. A white creamy substance was observed between the patient's buttocks. HHa #1 wiped the outer surface of the patient's buttocks but did not clean between the patient's buttocks near the anal area. Upon completion, the white creamy substance remained between the patient's buttocks. Upon completion of the visit, HHa #1 was queried as to why she failed to performed all tasks as ordered in the Aide plan of care and reported, "I guess I just get comfortable because I know her." HHa #1 failed to provide care and services as ordered in the plan of care. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 7/14/21 at 11:22 a.m. who reported, "It's been a challenge with them (Home Health Aides). She (HHa #1) is better with the ambulatory patients."

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 of 2 Home Health Aides employed by this agency, whose file was 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 7/15/21 at 9:26 a.m., a review of the Home Health Aide (HHa) personnel files revealed the following: HHa #2: Date of Hire was 11/3/11. There was no documented evidence in HHa #1's personnel file that the skilled discipline made an annual onsite visit at a patient's place of residency to ensure the adequate provision of care. These findings were reviewed with and confirmed by the Administrator (Adm #1) during an interview on 7/16/21.

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide documented evidence that the Administrator was appointed by and reported to the Governing Body, resulting in no definitive lines of authority, lack of oversight of patient care and operations of the agency, and the potential for poor patient outcomes. Findings include: On 7/13/21 at 12:36 p.m., the Administrator (Adm #1) was asked to provide the Governing Board meeting minutes that reflected the Administrator's appointment yet was unable to do so. There was no further documentation provided by the agency by the time of the survey exit on 7/16/21.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure a discharge summary was completed, provided the patient's current health status at the time of discharge, assessed progress toward goals, and was forwarded to the physician within 5 days of discharge in 1 (MR's #7), of 3 closed records, 7 records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: MR #7: The patient's SOC was 8/7/20 with diagnoses that included Multiple Sclerosis and hemiplegia. During the record review on 7/16/21 at 11:50 a.m., it was noted that Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT) and Home Health Aide (HHa) services were ordered to be provided. SN discharged the patient from the agency's services on 8/12/20. During the review, there was no documented evidence that a SN discharge summary had been completed and forwarded to the Physician within 5 days of the patient's discharge. These findings were reviewed with and confirmed by the Administrator (Adm #1) during an interview on 7/16/21 at 12:40 p.m.