Every finding on record at Kalamazoo Home Health Care, Inc

A Medicare emergency preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs (MDLARA) from May 11, 2026, through May 14, 2026, at: Kalamazoo Home Health Care Inc. 251 North Rose Street, Suite 218 Kalamazoo, MI 49007 This agency does not operate any branch offices or subunits. Clinical records reviewed for this survey: 2 discharged records, 2 records with home visits and 3 records without home visits for a total of 7 records reviewed. At the conclusion of the survey, the agency was found to be in compliance with the conditions of participation at 42 CFR Part 484.102, Emergency Preparedness.

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs (MDLARA) from May 11, 2026, through May 14, 2026 at: Kalamazoo Home Health Care Inc. 251 North Rose Street, Suite 218 Kalamazoo, MI 49007 This agency does not operate any branch offices or subunits. Clinical records reviewed for this survey: 2 discharged records, 2 records with home visits and 3 records without home visits for a total of 7 records reviewed. At the conclusion of the survey, the agency was found to be in substantial compliance with the conditions of participation at 42 CFR Part 484., Home Health Agencies.

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, 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. Findings include: During a review of the Agency's patient admission packet on 5/11/25 at 11:30 am, 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 (Staff-A) during an interview on 5/11/26 at 12:45 pm.

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 a medication profile and medication reconciliation was documented in the record for 2 (P-4 and P-7) of 7 records reviewed, resulting in the potential for medication related harm and adverse effects and drug interactions to go unaddressed by the agency and the clinician. Findings include: Patient #7’s (P-7) Start of Care (SOC) was dated 8/11/25. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury. During record review on 5/12/26, it was noted that the comprehensive assessment completed on 8/11/25 stated, “M2001 Drug Regimen Review: Did a complete drug regimen review identify potential clinically significant medications issues? 0 – No issues for during review.” A drug interaction report was completed withing the Electronic Medical Record (EMR) that noted the following “Major” severity medication interactions: Aspirin with Ibuprofen, Aspirin with Topiramate. The EMR contains no documented evidence that the physician was notified of the major severity medication interactions. During the entrance conference on 5/11/26 at 10:45 a.m., the administrator (Staff-A) stated, “Major medication interactions are to be reported to the physician.” The Administrator (Staff-A) reviewed and acknowledged the findings listed above in an interview on 5/14/26 at 10:00 am. Patient #4 (P-4): P-4 was admitted to home care on 8/28/25, with diagnoses of neurogenic bowel, neuromuscular dysfunction of bladder, and paraplegia. During record review on 5/11/26, it was noted that there was no documented medication profile or medication interaction report in the record. During review of the start of care comprehensive assessment on 5/11/26 under M2001, it was documented that issues were found during the medication drug review. There was no documentation of what level the drug interactions were, or if the physician was notified if needed, or what actions were needed, if any. During an interview on 5/14/26 at 10:55 am, the administrator (Staff-A) acknowledged the above findings.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the plan of care covered all pertinent interventions with reportable parameters and safety measures specific to the individualized needs of the patient in 6 (P-1, P-2, P-3, P-4, P-5 and P-7) of 7 records reviewed, resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes and unmet care needs. Findings include: Patient #4 (P-4): P-4 was admitted to home care on 8/28/25, with diagnoses of neurogenic bowel, neuromuscular dysfunction of bladder, and paraplegia. During record review on 5/11/26, it was noted that there were no diabetic precautions on the Plan of Care (POC) with a diagnosis of diabetes and insulin injections ordered before meals. The POC also failed do include parameters for when to contact the physician for vital signs and pain parameters. Patient #5 (P-5): P-5 was admitted to home care on 8/19/25, with diagnoses of contracture of left upper arm, and abnormality of gait. During record review on 5/12/26, it was noted that there were no pain parameters on the plan of care and the Start of Care (SOC) OASIS assessment states, “AFC staff report that when P-5 has pain, he gets very agitated and has explosive episodes. He has an additional PRN dose of oxycodone at hs (bedtime) but does not routinely need to take this dose. P-5 denies current pain when asked, but staff report when he has pain that is not managed, his mood, behavior, participation in ADLs are all effected.” Under Effectiveness of Pain Medication there is a question asking, “Is current pain medication treatment effective for pain? The yes and no boxes are unchecked. “How often is break through pain medication needed question; never, less often than daily, once daily, 2 or 3 times a day, more than 3 times a day boxes are all unchecked. The agency failed to include parameters for pain to notify the physician of break through pain other than at bedtime, and what actions to take. During an interview on 5/14/26 at 10:55 am, the administrator (Staff-A) acknowledged the above findings. Patient #1’s (P-1) Start of Care (SOC) was dated 5/2/25. The Plan of Care (POC) identified diagnoses of Muscle Weakness and Traumatic Brain Injury. During record review on 5/11/26, it was noted that the POC had Physical Therapy (PT) frequency of 2w9 (2 time per week for 9 weeks). The Physical Therapy Assistant (PTA) completed 2 visits during week 5, 5/27/25 and 5/29/25. The PT completed a 30-day evaluation visit on 5/29/25. The Electronic Medical Record (EMR) contained no evidence of an order to increase PT frequency. The agency failed to complete visits as ordered. Furthermore, the POC failed to contain vital sign parameters to notify the physician. Patient #2’s (P-2) Start of Care (SOC) was dated 6/26/25. The Plan of Care (POC) identified diagnoses of Low Back Pain and Traumatic Brain Injury. During record review on 5/13/26, it was noted that the POC had PT frequency of 2w9. The PTA completed 2 visits during week 5, 4/20/26 and 4/22/26. The PT completed a 30-day evaluation visit on 4/22/26. The EMR contained no evidence of an order to increase PT frequency. The agency failed to complete visits as ordered. Furthermore, the POC failed to contain vital sign parameters to notify the physician. Patient #3’s (P-3) Start of Care (SOC) was dated 8/7/25. The Plan of Care (POC) identified diagnosis of Paraplegia. During record review on 5/13/26, it was noted that the POC had PT frequency of 2w9. The PTA completed 3 visits during week 2, 3/6/26, 3/9/26 and 3/10/26. Furthermore, the PTA completed 2 visits during week 5, 3/27/26 and 3/28/26. The PT completed a 30-day evaluation visit on 3/29/26. The EMR contained no evidence of an order to increase PT frequency. The agency failed to complete visits as ordered. Furthermore, the POC failed to contain vital sign parameters to notify the physician. Patient #7’s (P-7) Start of Care (SOC) was dated 8/11/25. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury. During record review on 5/12/26, it was noted that the POC had PT frequency of 2w9 and Occupational Therapy (OT) 1w9. The PTA completed 3 visits during week 2, 2/8/26, 2/10/26 and 2/12/26. The EMR contained no evidence of an order to increase PT frequency. Furthermore, the OT completed 2 visits during weeks 3, 4 and 5, 2/15/26 and 2/19/26, 2/26/26 and 2/27/26, and lastly 3/5/26 and 3/7/26. The agency failed to complete visits as ordered. Furthermore, the POC failed to contain vital sign parameters to notify the physician. Additionally, it was noted that metformin (antidiabetic) 1000 mg two times daily was in medication profile with a start date of 7/11/25. It was noted that the POC Safety Measures failed to include diabetic precautions. The Administrator (Staff-A) reviewed and acknowledged the findings listed above in an interview on 5/14/26 at 10:00 am.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to address the potential for developing a urinary tract infection for 1 (P-6) of 1 patient with a history of urinary tract infections and an indwelling urinary catheter, resulting in the potential for hospitalization due to a urinary tract infection. Findings include: Patient #6 (P-6): Infection control documents for the agency's infection control program were requested for review on 5/11/26 and they documented that the agency’s patients had no infections in 2025 or 2026. However, review of P-6’s Plan of Care dated 9/2/25 under the ER/Hospital Re-Admission Risk factors and interventions Directives states, “History of urinary tract infections (UTI's).” Patient/Caregiver states, “Hospitalizations are due to: “I get sick or have an infection.” There was no documentation in the agency’s Infection Control program mentioning the history of UTIs or patient illnesses, or any documentation regarding tracking or evaluating for UTIs. There were no clinician visit notes in the record that documented the assessing of P-6 for UTI's when the patient had an indwelling urinary catheter. During an interview on 5/14/26 at 10:55 am, the administrator (Staff-A) acknowledged the above findings.

Supervise skilled professional assistants CFR(s): 484.75(c) Standard: Supervision of skilled professional assistants. This STANDARD is not met as evidenced by: Based on record review and interview, the physical therapist failed to supervise the services provided by the physical therapy assistant at least every 30 days for 2 (P-2 and P-3) of 7 records reviewed with physical therapy assistant services provided at least 30 days, resulting in the potential for unmet therapy needs. Findings include: Patient #2’s (P-2) Start of Care (SOC) was dated 6/26/25. The Plan of Care (POC) identified diagnoses of Low Back Pain and Traumatic Brain Injury. During record review on 5/13/26, the POC ordered therapy services of 2w9 (2 times a week for 9 weeks). The Physical Therapist (PT) completed a Supervisory Visit Note stating, “Visit Date: 3/30/26. Visit start: Blank. Visit end: Blank. Supervisor Signature: Staff-A. Date: 5/12/26.” The PT did not complete a visit on 3/30/26. Furthermore, the PT completed a Supervisory Visit Note stating, “Visit Date: 4/30/26. Visit start: Blank. Visit end: Blank. Supervisor Signature: Blank. Date: Blank.” The PT did not complete a visit on 4/30/26. The PT failed to complete the supervision of the Physical Therapy Assistant per agency policy. Patient #3’s (P-3) Start of Care (SOC) was dated 8/7/25. The Plan of Care (POC) identified diagnosis of Paraplegia. During record review on 5/13/26, the POC ordered therapy services of 2w9. The PT completed a Supervisory Visit Note stating, “Visit Date: 4/30/26. Visit start: Blank. Visit end: Blank. Supervisor Signature: Staff-A. Date: 5/12/26.” The PT did not complete a visit on 4/30/26. The PT failed to complete the supervision of the Physical Therapy Assistant per agency policy. During the entrance conference on 5/11/26 at 10:45 a.m., the administrator (Staff-A) stated, “PTA’s will be supervised monthly.” The Administrator (Staff-A) reviewed and acknowledged the findings listed above in an interview on 5/14/26 at 10:00 am.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to send a detailed discharge summary to the physician for 1 (P-4) of 2 discharge records reviewed, resulting in the physician having no knowledge of the patient's condition at discharge. Findings include: Patient #4 (P-4): P-4 was admitted to home care on 8/28/25, with diagnoses of neurogenic bowel, neuromuscular dysfunction of bladder, and paraplegia. During record review on 5/11/26, it was noted that the discharge summary dated 11/27/25, had the boxes for “Copy sent to MD, copy sent to facility, copy sent via fax, and copy sent via mail”, all left blank. P-4 was discharged from agency services on 11/27/25. There was no documented evidence in the record, that a detailed discharge summary report was sent to the physician within 5 days of the patient’s discharge. During an interview on 5/14/26 at 10:55 am, the administrator (Staff-A) acknowledged the above findings.

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, it was determined that the agency failed to have the clinicians submit their visit notes within 48 hours of the patient's visit for 5 (P-2, P-3, P-4, P-5, P-6) of 7 records reviewed, resulting in the potential for decreased continuity of care between clinicians and patient visits. Findings include: Patient #4 (P-4): P-4 was admitted to home care on 8/28/25, with diagnoses of neurogenic bowel, neuromuscular dysfunction of bladder, and paraplegia. During record review on 5/11/26, it was noted that the physical therapy (PT) visit notes dated 9/4, 9/10, 9/19, 9/23, 9/25, 9/30 and 10/2/25 were not signed by the PT until 10/5/25. Visit notes 10/7, 10/9, 10/14, 10/16, 10/21, 10/23, 10/27, 10/28, 10/30, 11/4/25 were not signed until 11/8/25. Visit notes 11/7, 11/11, 11/14, 11/18, 11/20/25 were not signed until 11/26/25. Patient #5 (P-5): P-5 was admitted to home care on 8/19/25, with diagnoses of contracture of left upper arm, and abnormality of gait. During record review on 5/12/26, it was noted that the physical therapy (PT) visit notes dated 4/21/26 and 4/23/26 were not signed by the PT until 4/27/26. The PT visit notes dated 4/28/26 and 5/5/26 were signed on 5/13/26 (during the survey). The PT visit note dated 5/8/26 was not signed as of 5/13/26. Patient #6 (P-6): P-6 was admitted to home care on 9/02/25, with diagnoses of diffuse traumatic brain injury with loss of consciousness of 30 minutes or less, and surgical procedure. During record review on 5/13/26, it was noted that the physical therapy (PT) visit notes dated 9/10/25, 9/15/25, and 9/23/25 were not signed by the PT until 10/1/25. The PT visit note dated 9/29/25 was not signed until 10/6/25. The PT visit notes dated 10/3/25, 10/9/25 and 10/17/25 were not signed until 10/31/25. The PT visit note dated 9/13/25 had no signature from the clinician as of 5/14/26. During the entrance conference on 5/11/26 at 10:45 a.m., the administrator (Staff-A) said visit notes were expected to be submitted within 48 hours of the patient visit. During an interview on 5/14/26 at 10:55 am, the administrator (Staff-A) acknowledged the above findings. Patient #2’s (P-2) Start of Care (SOC) was dated 6/26/25. The Plan of Care (POC) identified diagnoses of Low Back Pain and Traumatic Brain Injury. During record review on 5/13/26, it was noted that Physical Therapy (PT) was ordered at a frequency of 2w9 (2 times a week for 9 weeks). The Physical Therapy Assistant (PTA) completed the visit documentation on 5/1/26 for the following visits: 4/6/26, 4/10/26, 4/15/26, 4/16/26, 4/20/26 and 4/22/26. Furthermore, the PTA completed two visits on 5/5/26 and 5/8/26 that stated, “Status: In use.” Whereas all other completed visits stated, “Completed.” The agency failed to document visits timely per agency expectations. Patient #3’s (P-3) Start of Care (SOC) was dated 8/7/25. The Plan of Care (POC) identified diagnosis of Paraplegia. During record review on 5/13/26, it was noted that PT was ordered at a frequency of 2w9. The PTA completed the visit documentation on 5/1/26 for the following visits: 4/6/26, 4/9/26, 4/10/26, 4/13/26, 4/16/26, 4/20/26 and 4/22/26. The agency failed to document visits timely per agency expectations. During the entrance conference on 5/11/26 at 10:45 a.m., the administrator (Staff-A) stated, "Visit notes were expected to be submitted within 48 hours of the patient visit." The Administrator (Staff-A) reviewed and acknowledged the findings listed above in an interview on 5/14/26 at 10:00 am.

The following Condition level deficiencies were identified during a Medicare authorized recertification Emergency Preparedness survey conducted by the Michigan Department of Licensing and Regulatory Affairs from 2/7/23 to 2/10/23 at: Kalamazoo Home Health Care 251 N. Rose St., Suite 218 Kalamazoo, MI 49007 This agency maintains no branch sites. At the conclusion of the survey, the agency was found to be out of compliance with the regulatory requirements at 42 CFR 484.102, Emergency Preparedness.

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] 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: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[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 complete an Emergency Preparedness Plan that was based on a facility and community based risk assessment (E0006); facility failed to develop and maintain an emergency preparedness communication plan that included contact information for all patient's physician (E0030); failed to develop and maintain an emergency preparedness training and testing program for staff based on the agency's emergency plan, resulting in agency personnel not being educated in actions to take in the event of an actual disaster. This deficient practice could affect all 8 patients currently serviced by this Agency (E0036); and failed to perform testing of their emergency preparedness program as required (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.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to conduct a facility-based and community-based risk assessment resulting in the potential for failure to identify hazards associated with the facility and less than optimal outcomes during an emergency event. This could potentially affect staff, and all patients serviced by this agency in the event of an emergency. Findings include: On 2/7/23 at 10:00 am., the ADM#1 (Administrator #1) was asked if the agency had conducted the required risk assessment and reported, "It has not been updated since the last survey." Upon review of the presented documentation, there was no evidence that the facility conducted a risk assessment utilizing an all-hazards approach with regards to natural, man-made, facility and geographic related emergencies.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(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 facilities]. 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 Agency failed to develop and maintain an emergency preparedness communication plan that included contact information for all patient's physician, which had the potential to negatively affect the health and safety of the patients serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency. Findings include: On 2/7/23, review of the Agency's Emergency Preparedness Plan (EP) failed to provide any evidence that a review or updates had been documented. This deficient practice was confirmed during an interview with ADM#1 (Administrator #1) on 2/7/23 at 10:00 am and confirmed the findings stating, "It has not been updated since the last survey."

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to develop and maintain an emergency preparedness training and testing program for staff based on the agency's emergency plan, resulting in agency personnel not being educated in actions to take in the event of an actual disaster. This deficient practice could affect all patients serviced by this Agency. Findings include: During review of the agency's Emergency Preparedness documents and policies on 2/7/23, it was noted that the Agency did not have documented evidence that they had developed a training and testing program for staff that was based on the agency's emergency plan. The above findings were reviewed with and confirmed by the ADM#1 (Administrator #1) during an interview on 2/7/23 at 10:00 am, who stated, "Nothing has been updated since the last survey.”

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined that the Agency ailed to provide documentation for the required annual tabletop and community based full-scale exercises nor any documentation of an actual event that would qualify as a test of the emergency plan, resulting in the potential to affect all patients and staff, in the event staff is not properly prepared for an emergency. Findings include: On 2/7/23 at 10:00, ADM#1 (Administrator #1) was queried about annual staff emergency preparedness drills and tabletop exercises and stated, "We have not done that. We have not done anything since the last survey." The Agency failed to document the needed exercises designed for the preparation of emergency situations within the Agency and surrounding community.

A Medicare recertification survey which included a COVID-19 Vaccination protocol review, was conducted by the Michigan Department of Licensing and Regulatory Affairs from 2/7/23 to 2/10/23 at: Kalamazoo Home Health Care 251 N. Rose St., Suite 218 Kalamazoo, MI 49007 At the time of the survey, the agency did not have any branch offices or subunits. The services the agency provided were: Skilled Nursing (SN), Physical Therapy (PT), and Occupational Therapy (OT). Clinical records reviewed included: 7 active records. The following Condition level deficiencies were identified at: 42 CFR § 484.55 Condition of participation: Comprehensive assessment of patients. 42 CFR § 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). 42 CFR § 484.70 Condition of participation: Infection prevention and control. 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).

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 included a review of all medications by a registered nurse in 2 records (MR #4, 7), from a total of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency, and failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects, and failed to provide documented evidence that the physician was notified of identified drug interactions in 4 (MR's #1, 4, 5, 6) of 7 sampled records reviewed (See G536); and failed to ensure the comprehensive assessment was updated to include an assessment of the patient's current health status and continuing needs for home health services for 5 (MR #2, 3, 4, 5, 6) of 7 records in which the patient was recertified for home care, from a total sample of 7 records reviewed, resulting in the potential for the rendering of ineffective treatment and services and unmet care needs (G546); failed to ensure the comprehensive assessment was updated and revised within 48 hours of the patient's return home post discharge from a hospital for 1 of 1 record reviewed (MR# 3) in which care had been resumed following hospitalization (See G548). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care for all the patients the Home Health Agency serves.

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 that the Agency (HHA) failed to ensure the comprehensive assessment included a review of all medications by a registered nurse in 2 records (MR #4, 7), from a total of 7 sampled records reviewed, resulting in the potential for harmful medication effects for all patients serviced by this Agency, and failed to ensure the comprehensive assessment included a review of all medications to determine any adverse effects, and failed to provide documented evidence that the physician was notified of identified drug interactions in 4 (MR's #1, 4, 5, 6) of 7 sampled records reviewed, resulting in the potential for harmful medication. Findings include: MR#1: The Start of Care (SOC) was dated 6/4/21. The Plan of Care (POC) identified diagnoses of Hemiplegia and Hypertension. During record review on 2/7/23, a medication interaction report was completed in the EMR and noted 1 Major Drug Interaction: Tramadol HCL and Venlafaxine HCL. There was no documented evidence, during the 2/7/23 clinical record review, that a drug interaction review had in fact been conducted to identify any adverse reactions or effects, or documented evidence that the physician had been notified of the above findings. MR#4: The Start of Care (SOC) was dated 10/16/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury and Difficulty Walking. During record review on 2/9/23, a medication interaction report was completed in the EMR and noted 1 Major Drug Interaction: Divalproex Sodium and Lamotrigine. There was no documented evidence, during the 2/9/23 clinical record review, that a drug interaction review had in fact been conducted to identify any adverse reactions or effects, or documented evidence that the physician had been notified of the above findings. Additionally, the medication profile dated 7/20/22 was signed by the PT. There was no documented evidence that the patient's medications had been reviewed by a registered nurse for possible drug interactions and duplicate drug therapy. MR#5: The Start of Care (SOC) was dated 1/31/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury, Depression and Morbid Obesity. During record review on 2/9/23, a medication interaction report was completed in the EMR and noted 3 Major Drug Interactions: Propranolol HCL and Ipratropium-Albuterol, then Naproxen and Apixaban, then Clozapine and Lorazepam. On 6/28/22, the Skilled Nurse documented, “Major drug interactions identified. MD will be sent a copy of this med profile. MR#6: The Start of Care (SOC) was dated 10/21/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury, Difficulty Walking and Neuropathy. During record review on 2/9/23, a medication interaction report was completed in the EMR and noted 2 duplicate therapy medications: Venlafaxine HCL and Paroxetine HCL, then Clonazepam and Clobazam. On 8/25/22, the Skilled Nurse documented, “Will send copy of medications interactions to physician. MR#7: The Start of Care (SOC) was dated 2/7/19. The Plan of Care (POC) identified diagnoses of Left Leg Partial Paralysis and Bipolar. During record review on 2/10/23, it was noted that the medication profile dated 12/22/22 was signed by the PT. There was no documented evidence that the patient's medications had been reviewed by a registered nurse for possible drug interactions and duplicate drug therapy. These findings were reviewed with and acknowledged by the Administrator (Adm#1) during an interview on 2/10/23 at 12:30 pm, and stated, “I do not have evidence of sending interactions to the physicians.”

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was updated to include an assessment of the patient's current health status and continuing needs for home health services for 5 (MR #2, 3, 4, 5, 6) of 7 records in which the patient was recertified for home care, from a total sample of 7 records reviewed, resulting in the potential for the rendering of ineffective treatment and services and unmet care needs. Findings included: MR#2: The Start of Care (SOC) was dated 9/8/22. The Plan of Care (POC) identified diagnoses of Injury of Head and Seizures. During record review on 2/8/23, it was noted that the Skilled Nurse (SN) completed a comprehensive assessment on 9/8/22 with an ordered frequency of 1w1 (1 visit a week for 1 week) and a certification period of 9/8/22-11/6/22. The Physical Therapist (PT) completed an evaluation on 9/9/22 with an ordered frequency of 1w1, 2w8. The PT continued to complete Physical Therapy Evaluations dated: 10/28/22, 11/29/22, 12/28/22, and 1/24/23 without completing a comprehensive assessment update. At the time of the clinical record review, no Recertification Oasis (assessment) documents had been completed. MR#3: The Start of Care (SOC) was dated 10/16/20. The Plan of Care (POC) identified diagnoses of Quadriplegia and Chronic Obstructive Pulmonary Disease. During record review on 2/8/23, the PT completed an evaluation without a comprehensive assessment on 10/16/20 with an ordered frequency of 1w1, 3w8. The PT continued to complete Physical Therapy Evaluations dated: 11/24/20, 2/12/21, 3/30/21, 4/29/21, 5/27/21, 6/29/21, 7/29/21, 8/26/21, 9/30/21, 10/29/21, 11/20/21, 12/28/21, 1/20/22, 3/5/22, 5/4/22, 5/31/22, 6/30/22, 8/30/22, 9/30/22, 10/28/22, 11/30/22, 12/28/22, and 1/9/23 without completing a comprehensive assessment update. At the time of the clinical record review, no Recertification Oasis (assessment) documents had been completed. MR#4: The Start of Care (SOC) was dated 10/16/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury and Difficulty Walking. During record review on 2/9/23, the PT completed an evaluation without a comprehensive assessment on 10/16/20 with an ordered frequency of 2w9. The PT continued to complete Physical Therapy Evaluations dated: 11/24/20, 12/29/20, 2/10/21, 3/30/21, 4/30/21, 5/27/21, 6/29/21, 7/29/21, 8/31/21, 9/30/21, 10/29/21, 11/30/21, 12/21/21, 1/28/22, 3/4/22, 4/29/22, 5/31/22, 6/30/22, 7/28/22, 8/30/22, 10/4/22, 11/2/22, and 11/29/22 without completing a comprehensive assessment update. At the time of the clinical record review, no Recertification Oasis (assessment) documents had been completed. MR#5: The Start of Care (SOC) was dated 1/31/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury, Depression and Morbid Obesity. During record review on 2/9/23, the Occupational Therapist (OT) completed an evaluation without a comprehensive assessment on 1/31/20 with an ordered frequency of 2w4. The OT continued to complete Occupational Therapy Evaluations dated: 2/24/20, 3/31/20, 4/30/20, 5/26/20, 6/26/20, 7/28/20, 8/25/20, 9/23/20, 10/27/20, 11/27/20, 12/31/20, 1/28/21, 2/28/21, 3/29/21, 4/23/21, 5/27/21, 6/30/21, 7/31/21, 8/28/21, 9/26/21, 10/26/21, 11/23/21, 12/30/21, 1/4/22, 2/28/22, 3/30/22, 4/27/22, 5/30/22, 6/27/22, 7/23/22, 8/24/22, 9/29/22, 10/27/22, 11/26/22, 12/29/22, and 1/25/23 without completing a comprehensive assessment update. At the time of the clinical record review, no Recertification Oasis (assessment) documents had been completed. MR#6: The Start of Care (SOC) was dated 10/21/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury, Difficulty Walking and Neuropathy. During record review on 2/9/23, the PT completed an evaluation without a comprehensive assessment on 10/21/20 with an ordered frequency of 3w9. The PT continued to complete Physical Therapy Evaluations dated: 11/24/20, 12/29/20, 1, 29/21, 3/10/21, 3/31/21, 4/30/21, 5/27/21, 6/22/21, 7/29/21, 8/31/21, 9/30/21, 10/29/21, 11/30/21, 12/30/21, 2/2/22, 3/4/22, 3/31/22, 4/29/22, 5/31/22, 6/30/22, 7/28/22, 8/30/22, 9/30/22, 10/31/22, 11/29/22, 1/3/23 and 1/31/23 without completing a comprehensive assessment update. At the time of the clinical record review, no Recertification Oasis (assessment) documents had been completed. These findings were reviewed with and acknowledged by the Administrator (Adm#1) during an interview on 2/10/23 at 12:45 pm and stated, “The recertification's have not been done. We have been charting to what is required for the automotive insurance requirements.”

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to conduct a Resumption of Care assessment within 48 hours of the patients discharge from a hospital, and assess the patient's continuing needs related to hospitalization in 1 (MR #3) of 1 records in which the patient was transferred to an inpatient facility, from a total of 7 records reviewed resulting in the potential for unidentified health concerns and failure to meet the patent's needs. Findings include: MR#3: The Start of Care (SOC) was dated 10/16/20. The Plan of Care (POC) identified diagnoses of Quadriplegia and Chronic Obstructive Pulmonary Disease. During record review on 2/8/23, it was noted that on 12/29/22 the Occupational Therapist (OT) documented a missed visit stating, “Patient unable to be seen today due to hospitalization at Bronson Hospital.” The Physical Therapist (PT) completed a visit on 1/3/23, which contained no documentation of the patient’s hospitalization. Additionally, on 1/9/23 and 1/10/23 the PT documented a missed visit stating, “Pt (patient) currently in Bronson hospital.” The following completed visit was on 1/13/23 by the OT and stated, “…has returned home from the hospital diagnosed with Pneumonia…” There was no documented evidence that a Resumption of Care (ROC) assessment had been completed within 48 hours of the patient's return to the home from both hospital stays of 24 hours or more at the time of this survey. These findings were reviewed with and acknowledged by the Administrator (Adm#1) during an interview on 2/10/23 at 12:30 pm.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care (POC) included medications, diet, emergency risks and advance directives to meet the needs of the patient for 4 of 7 records reviewed (MR#s 3, 5, 6, and 7), resulting in patients not receiving care specific to their individual needs and the potential for poor patient outcomes. Findings include: **Agency Policy: "Plan of Care (POC) (Effective date 1/13/2018). The policy states, "2. POC Development: The POC is: … H. Required to include all pertinent diagnoses, the patient’s mental, psychosocial, and cognitive status, the types of services, supplies, and equipment required, the frequency and duration of visits to be made, prognosis, rehabilitation potential, functional limitations, activities permitted, nutritional requirements, all medications and treatments, safety measures to protect against injury.” MR#3: The Start of Care (SOC) was dated 10/16/20. The Plan of Care (POC) identified diagnoses of Quadriplegia and Chronic Obstructive Pulmonary Disease. During record review on 2/8/23, it was noted that all Physical Therapy evaluation/plan of cares dated from 10/16/20-2/8/23 failed to include medications, diet, risk for emergency department visits and advanced directives. MR#5: The Start of Care (SOC) was dated 1/31/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury, Depression and Morbid Obesity. During record review on 2/9/23, it was noted that all Physical Therapy evaluation/plan of cares dated from 1/31/20-2/9/23 failed to include medications, diet, risk for emergency department visits and advanced directives. MR#6: The Start of Care (SOC) was dated 10/21/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury, Difficulty Walking and Neuropathy. During record review on 2/9/23, it was noted that all Physical Therapy evaluation/plan of cares dated from 10/21/20-2/9/23 failed to include medications, diet, risk for emergency department visits and advanced directives. MR#7: The Start of Care (SOC) was dated 2/7/19. The Plan of Care (POC) identified diagnoses of Left Leg Partial Paralysis and Bipolar. During record review on 2/10/23, it was noted that all Physical Therapy evaluation/plan of cares dated from 2/7/19-2/8/23 failed to include medications, diet, risk for emergency department visits and advanced directives. These findings were reviewed with and acknowledged by the Administrator (Adm#1) during an interview on 2/10/23 at 12:30 pm.

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 policy review and interview, it was determined the home health agency failed to develop a Quality Assessment and Performance Improvement (QAPI) policy and program, (G-642); the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, (G-644); failed to document the quality improvement projects for 2020, 2021, and 2022 and document the reasons for conducting these projects and the measurable progress achieved each year (G-658). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care for all the patients the Home Health Agency serves for the condition of participation of 42 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 record review and interview, it was determined the agency failed to develop, implement, and maintain a quality assessment and performance improvement program which had the potential to negatively affect all 8 active patients, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: The agency's Quality Assessment and Performance Improvement (QAPI) documentation was reviewed on 2/10/23. There was no documentation to support the agency's performance improvement activities regarding their efforts to systematically collect data, monitor, analyze and improve patient outcomes. The QAPI binder contained documentation and instructions for a QAPI program, but had no additional data added, thus unable to quantitively demonstrate improvements. The Administrator (Adm#1) was questioned regarding QAPI indicators and process to measure on 2/10/23 at 10:45 am and stated, "We have not done anything with QAPI since the last survey." The agency failed to ensure their QAPI program was at least capable of showing measurable improvements in indicators to improve patient outcomes, safety and quality of care.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency failed to collect and use data to monitor the effectiveness, safety of services and quality of care and identify opportunities for improvement by the quality assessment and performance improvement program, which had the potential to negatively affect all patients serviced by the agency, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: During an interview on 2/10/23 at 10:45 am a request was submitted to review the QAPI (quality assessment performance improvement) documents for 2020, 2021 and 2022. There was no documentation to support the agency's performance improvement activities regarding their efforts to systematically collect data, monitor, analyze and improve patient outcomes. The QAPI binder contained documentation and instructions for a QAPI program, but had no additional data added, thus unable to quantitively demonstrate improvements.

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 2020, 2021 and 2022 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 2/10/23 at 10:45 am 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, "We do not have any improvement projects."

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to maintain an agency wide infection control program for surveillance, identification, prevention, and control (G684); and failed to maintain a process for tracking and securely documenting the COVID-19 vaccination status of all staff (G687). Findings include: The cumulative effects of these systemic problems resulted in the agency's inability to ensure the provision of safe health care for the condition of participation of 42 CFR§484.70 Infection Prevention and Control.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the agency's Quality Assessment Performance Improvement program, resulting in the potential spread of infections between patient care staff and the agency's 8 active patients. On 2/10/23, the agency's Quality Assessment Performance Improvement (QAPI) documentation was reviewed. When queried to review an infection tracking binder, Administrator (Adm.#1) replied, "We have not yet kept track of staff and patient illnesses." The agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to establish Vaccine protocol written policies and procedures that included (iv) a process for tracking and securely documenting the COVID-19 vaccination status of all staff, resulting in the potential for the development and spread of the COVID-19 virus to staff and all patients serviced by this Agency. Findings include: On 10/20/22, upon review of the Agency’s COVID policy, it was noted that requirements had not been met. There was no staff list containing the vaccination status of each employee for those who have been vaccinated or “exemption” noted for those unvaccinated. There was no documentation of what vaccine was received and or if a booster had been administered. These findings were discussed with and acknowledged by the Administrator (Adm.#1) during an interview on 2/10/23.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure clinical notes were accurate for 4 of 7 (MR# 3, 5, 6, 7) records reviewed, resulting in the potential to negatively affect the health and well-being of these patients. Findings include: MR#3: The Start of Care (SOC) was dated 10/16/20. The Plan of Care (POC) identified diagnoses of Quadriplegia and Chronic Obstructive Pulmonary Disease. During record review on 2/8/23, it was noted that Physical Therapy (PT) was ordered at a frequency of 2w9 (2 times a week for 9 weeks) effective 12/28/22. Additionally, Occupational Therapy (OT) was ordered at a frequency of 2w9 effective 12/27/22. It was noted that the Physical Therapy evaluation and care plan dated 1/19/23 is blank under the sections: Problems list, Goals for this certification, interventions, and additional goals. Additionally, the last completed PT visit note was dated 1/30/23. Furthermore, the last OT visit note was completed on 2/2/23. The administrator (Adm#1) was questioned during the entrance interview on 2/7/23 at 11:30 am regarding timeframe of completing visit documentation and stated, “Visit notes are expected to be completed within 48hrs of the visit.” The agency failed to document visits timely. MR#5: The Start of Care (SOC) was dated 1/31/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury, Depression and Morbid Obesity. During record review on 2/9/23, it was noted that PT was ordered at a frequency of 2w9 effective 12/30/22. Additionally, OT was ordered at a frequency of 2w9 effective 1/25/23. The last PT visit note was dated 1/31/23 and the last OT visit note was dated 2/2/23. The agency failed to document visits timely. MR#6: The Start of Care (SOC) was dated 10/21/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury, Difficulty Walking and Neuropathy. During record review on 2/9/23, it was noted that PT was ordered at a frequency of 2w9 effective 1/3/23. Additionally, OT was ordered at a frequency of 2w9 effective 1/24/23. The last PT visit note was dated 1/31/23 and the last OT visit note was dated 2/2/23. The agency failed to document visits timely. MR#7: The Start of Care (SOC) was dated 2/7/19. The Plan of Care (POC) identified diagnoses of Left Leg Partial Paralysis and Bipolar. During record review on 2/10/23, it was noted that PT was ordered at a frequency of 2w9 effective 12/22/22. The last PT visit note was dated 1/31/23. The agency failed to document visits timely. These findings were reviewed with and acknowledged by the Administrator (Adm#1) during an interview on 2/10/23 at 12:50 pm.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure that discharge summaries were sent to the physician within 5 days of discharge for 2 of 7 records reviewed resulting in incomplete results for the physicians' consideration for continuing primary care of the patient. Findings include: MR#3: The Start of Care (SOC) was dated 10/16/20. The Plan of Care (POC) identified diagnoses of Quadriplegia and Chronic Obstructive Pulmonary Disease. During record review on 2/8/23, it was noted transfer summaries were not completed when the patient was hospitalized on 12/29/22 and 1/9/23, thus they were not sent to the physician within 2 business days. MR#4: The Start of Care (SOC) was dated 10/16/20. The Plan of Care (POC) identified diagnoses of Traumatic Brain Injury and Difficulty Walking. During record review on 2/9/23, it was noted that the agency failed to verify that the discharge summary was sent to the physician within 5 business days of the patient's discharge. Additionally, it was noted that the Physical Therapy discharge summary dated 12/20/22 was blank. These findings were reviewed with and acknowledged by the Administrator (Adm#1) during an interview on 2/10/23 at 12:55 pm.