Every finding on record at Trillium Home Care Solutions, LLC

A Medicare authorized revisit survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on 8/3/21 at: Trillium Home Care Solutions 28592 Orchard Lake Rd., Suite 340 Farmington Hills, MI 48334 At the conclusion of the survey, teh agency was found in substantial compliance with the requirements for participation in Medicare/Medicaid at 42 CFR§484.102, Emergency Preparedness.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the services of Physical Therapy and Social Work were provided as ordered by the physician for 1 of 1 (MR# 1) record reviewed from a total sample of 1 record, resulting in a lack of services and the potential for poor patient outcomes for this patient. Findings include: Policy: "Assessment and Reassessment Guidelines" 484.55 (undated) stated, "Additional disciplines Physical Therapy (PT), Occupational Therapy (OT), and Medical Social Workers (MSW), will have 72 hours as stated in the referral in which to complete the evaluation." MR #1: The patient's start of care (SOC) was 7/7/21 with diagnoses that included hypertension, schizophrenia, and anxiety disorder. The 7/7/21 plan of care ordered Skilled Nursing, Physical Therapy (PT), and Master of Social Work (MSW) services for this patient. During record review on 7/29/21, it was noted both PT and MSW evaluations occurred on 7/14/21. 7 days after the start of care. There was no documentation to indicate the patient or care giver had declined or delayed PT and MSW services. No documentation was found that the physician had been notified that services were not provided as ordered. All members of the Governing Board (GB) were present during the time of interview, and the decision was made by the GB to update the agency's policy referenced above to ensure services were furnished timely once the order had been received. These findings were reviewed with and acknowledged by the Alternate Administrator (A-Adm #1) and Clinical Manager (CM #1) during an interview on 7/29/21 at 2:10 PM. A-Adm #1 stated, "I'm surprised our policy doesn't have any timelines when we need to go see the patient, I would've thought it was three days. We can get this fixed right now."

Administrator must: CFR(s): 484.105(b)(1) Standard: Administrator. The administrator must: This STANDARD is not met as evidenced by: Based on documents reviewed and interview, it was determined the Administrator failed to ensure that Federal and State agencies were notified of the Agency's change of address, resulting in the potential for the Agency to be operating out of compliance with Federal requirements. Findings include: During a revisit survey on 7/29/21, it was discovered the Agency's current address was different from the address listed in the State of Michigan's database. When the Administrator (Adm#1) was requested to show documentation of an CMS (Centers for Medicare & Medicaid) approval letter recognizing the change of address (COA), Adm#1 provided an 855 application with an old address (30800 Telegraph Rd., Bingham Farms MI) with an effective date of 1/6/2021. The Agency had since relocated to the current address (28592 Orchard Lk Rd., Farmington Hills MI) on 5/3/21. Adm#1 then submitted notification from NGS (National Government Services) that a new 855 application concerning the current COA was received on 7/29/2021. At the end of survey, no documentation of an approval letter from CMS concerning the COA was received. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 7/29/21 at 3:25 PM. Adm #1 stated, "When I get approval from NGS, I'll make sure to forward it on to CMS so I can get their approval letter, and then I should be all set."

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on document review and interview, the Agency failed to ensure that at least one qualifying service was provided directly by agency employees, resulting in the potential for interruption in continuity of care and unmet care needs. Findings include: On 8/3/21 at 1:10 PM, review of CMS (Centers for Medicare & Medicaid) form 1572 noted under section (G21) "Services Offered" that all services furnished by the Agency were under contract or "Under Arrangement." At the time of exit (2:15 PM), no evidence was found that indicated the Agency provided at least one of the services directly as required. These findings were discussed with and acknowledged by Adm #1 at the time of discovery.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined that the agency failed to ensure the clinical record was complete, including assessments, notes and evaluations, for 1 (MR #1) of 1 record from a total of 1 record reviewed, resulting in an incomplete record, an incomplete depiction of the patient's health status, and the potential for unmet care needs. Findings include: Policy: "Timely Submission of Patient Documentation" 11.5.1 (undated) stated, "All patient visit reports from contract personnel/employed staffs must be submitted within three (3) business days from the date of the visit, e.g., PT, SLP, etc." MR #1: The patient's start of care (SOC) was 7/7/21 with diagnoses that included hypertension, schizophrenia, and anxiety disorder. During review of the clinical record on 7/29/21, it was noted that the following services were ordered: Skilled Nursing (SN), Physical Therapy (PT), and Master of Social Work (MSW). The ordered visit frequency on the Plan of Care for SN was 2wk1 (twice a week for one week), and 1wk3. PT was 1wk1, 2wk2, 1wk4. MSW was evaluation only. During the review, the last documented clinical entry for all services was 7/15/21. These findings were reviewed with and acknowledged by the Alternate Administrator (A-Adm #1) and Clinical Manager (CM #1) during an interview on 7/29/21 at 1:45 PM. A-Adm #1 stated, "We'll work on making sure they get their notes in on time."

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 interview record review, the agency failed to develop an Emergency Preparedness plan that included policies, procedures, a communication plan, exercises, training, and testing. These practices could affect the health and safety of all agency patients in the event of a natural, man-made, or facility-based emergency. The cumulative effect of these systemic problems resulted in the agency's inability to ensure patient safety during an emergency which could result in the agency not providing quality health care. Findings include: 1. The agency failed to include a process for cooperation and collaboration with local, regional, State and Federal emergency preparedness officials to maintain an integrated response during a disaster or emergency; and failed to document their efforts in contacting these officials to engage in planning for an integrated emergency response, resulting in ineffective Emergency Preparedness planning. (See E0009) 2. The agency failed to ensure the Emergency Preparedness Plan included procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency and to inform state and local officials of any on-duty staff or patients they are unable to contact, which could negatively affect the health and safety of all agency staff and patients, resulting in the agency not being prepared to respond effectively during an emergency. (See E0021) 3. The agency failed to ensure the emergency preparedness communication plan included a means for sharing information about the agency's occupancy, needs and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee, affecting all patients served by the agency, resulting in the lack of essential information in the event of an actual emergency. (See E0034) 4. The agency failed to develop and maintain an Emergency Preparedness training and testing program that is based on the emergency plan, risk assessment, policies, procedures, and the communication plan. The training and testing program must be reviewed and updated at least annually. (See 0036) 5. The agency failed to conduct exercises to annually test the emergency plan or provide documentation of an actual event that would qualify as a test of the emergency plan; failed to conduct an additional full-scale exercise or a table-top exercise; and failed to analyze the clinic's response to and maintain documentation of all drills, tabletop exercises, emergency events and revise the emergency plan as needed. (see 0039)

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years (annually for LTC facilities). The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency. This STANDARD is not met as evidenced by: Based on policy review and interview, the Home Health Agency (HHA) failed to include a process for cooperation and collaboration with local, regional, State and Federal emergency preparedness officials to maintain an integrated response during a disaster or emergency; and failed to document their efforts in contacting these officials to engage in planning for an integrated emergency response, resulting in ineffective Emergency Preparedness planning. Findings include: During a review of the agency's Emergency Preparedness Plan on 5/18/21 at 10:30 am, it was noted that the policy failed to include documented evidence of the facility's efforts to contact the above officials and, when applicable, of its participation in collaborative and cooperative planning efforts. These findings were reviewed with the owner during an interview on 5/18/21 at 12:30 PM. When asked to provide documentation of efforts to contact the above officials, the owner stated, "I haven't contacted any of the local officials yet."

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years.] At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined that the agency failed to ensure the Emergency Preparedness Plan included procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency and to inform state and local officials of any on-duty staff or patients they are unable to contact, which could negatively affect the health and safety of all agency staff and patients, resulting in the agency not being prepared to respond effectively during an emergency. Findings include: During the review of the Emergency Preparedness binder dated 2017, it was noted that it did not include procedures for following up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. There were no procedures for notifying state and local officials of any staff or patients the agency was unable to reach. During an interview on 5/18/21 at 12:15 pm., the owner acknowledged and agreed with the above findings."

Information on Occupancy/Needs CFR(s): 484.102(c)(6) [(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: (7) [(5) or (6)] A means of providing information about the [facility's] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice's inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness communication plan included a means for sharing information about the agency's occupancy, needs and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee, affecting all patients served by the agency, resulting in the lack of essential information in the event of an actual emergency. Findings include: On 5/18/21, the agency's "Emergency Preparedness" binder dated 2017, was reviewed. During the review it was discovered that there was no means for sharing information about the facility's occupancy, needs and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. During an interview on 5/18/21 at 12:20 p.m., the owner agreed with the above findings."

EP Training and Testing CFR(s): 484.102(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, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, 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 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 interview and record review, the agency failed to develop and maintain an Emergency Preparedness training and testing program that is based on the emergency plan, risk assessment, policies, procedures, and the communication plan. The training and testing program must be reviewed and updated at least annually. This deficient practice could affect the health and safety of all agency patients in the event of a natural, man-made, or facility-based emergency. Findings include: On 5/18/21, the agency's "Emergency Preparedness" binder dated 2017, was reviewed. During the review it was discovered there was no documented evidence the agency had developed a training and testing program to guide personnel and agency actions during an emergent situation. All agency patients could be impacted by the agency's failure to develop and maintain an emergency preparedness training and testing program. During an interview 0n 5/18/21 at 12:30 p.m., the owner acknowledged the Emergency Preparedness program did not have any training and testing and would need to be updated.

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 home health agency failed to conduct exercises to annually test the emergency plan or provide documentation of an actual event that would qualify as a test of the emergency plan; failed to conduct an additional full-scale exercise or a table-top exercise; and failed to analyze the clinic's response to and maintain documentation of all drills, tabletop exercises, emergency events and revise the emergency plan as needed. This deficient practice could affect the health and safety of all clinic patients in the event of a facility emergency or disaster. Findings include: On 5/18/21, the agency's emergency preparedness documentation was reviewed and it was discovered there was no documentation of a full-scale exercise or a table-top exercise for the previous 3 years, or an analysis of the clinic's response to all drills, tabletop exercises, emergency events and revisions to the emergency plan as needed. The finding was confirmed during an interview on 5/18/21 at 1230 p.m., with the owner.

A Medicare authorized recertification and COVID-19 Infection Control survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on 5/18/21 at: Trillium Home Care Solutions 28592 Orchard Lake Rd. Farmington Hills, MI 48334 At the time of the survey, the agency did not operate any branch offices or subunits. No clinical records were reviewed for this survey due to a zero census and only 1 active patient in the previous 3 years. The agency was unable to retrieve the 1 patient record. The following Condition level deficiencies were identified at: 42 CFR § 484.102 Emergency Preparedness. 42 CFR § 484.105 Organization and Administration of Services. 42 CFR § 484.65 Quality Assessment/performance improvement. 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 §484.36 (a)(2)(i). A Medicare authorized recertification survey was attempted by the Michigan Department of Licensing and Regulatory Affairs on 2/24/21 at: Trillium Home Care Solutions 31471 Northwestern Hwy., Suite 3 Farmington Hills, MI 48334 Upon arrival at the above address at 10:45 a.m., there were no visible signs of occupancy. There was no answer to the building's locked door. The office had no lights on and appeared empty. A receptionist at "Achieve Rehab" across the hallway stated, "They have not been there for over 6 months" A call was placed to the agency's listed number (248-702-6895) with the response, "Welcome to Verizon wireless. Your call can not be completed as dialed. Please try your call again later." An internet search revealed an additional number (248-476-3100) which rang to a fax line and an address of 25882 Orchard Lake Rd, Farmington Hills 48336. The additional address was also empty with no answer to the locked door. No other businesses were found open to conduct an interview to gather further information. A Surveyor's business card was left in the door of the agency's address. No survey could be conducted as this agency was deemed non-operational.

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, it was determined the agency failed to develop a Quality Assurance Performance Improvement program that was capable of showing measurable improvement in health outcomes, patient safety and quality of care by collecting, measuring, analyzing and tracking quality indicators to assess the agency's processes of care, services and operations (see G 642); failed to develop a Quality Assessment Performance Improvement program that selected, performed and documented annual quality improvement projects for the 2019, 2020 and 2021 calendar years (see G 658); and the Governing Body failed to ensure the agency had an active, functioning and ongoing Quality Assessment and Performance Improvement program that fulfilled all the regulatory requirements of this section (see G 660), resulting in the potential for repeated unmet patient outcomes, poor safety for patients and provision of substandard care.

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, it was determined the agency failed to develop a Quality Assurance Performance Improvement program that was capable of showing measurable improvement in health outscomes, patient safety and quality of care by collecting, measuring, analyzing and tracking quality indicators to assess the agency's processes of care, services and operations, resulting in the potential for repeated unmet patient outcomes, poor safety for patients and provision of substandard care. Findings include: On 5-18-21 at 12:45 PM, during an interview, the Agency Owner was asked to provide documentation showing the Governing Body's approval and oversight of the agency's QAPI (Quality Assessment Performance Improvement) program and the QAPI program documentation. The Owner was unable to provide the requested documents and stated, "We haven't done any QAPI activities since I bought the agency in 2018. The staff were supposed to start the QAPI program this week, but we don't have anything done for the QAPI program right now." There was no evidence of any data collection, analysis, tracking or implementation of any corrective actions to show measurable improvement in patient outcomes, the quality and safety of patient care for the years 2018, 2019, 2020 and 2021. There was no documentation of any Governing Body activity/oversight of the QAPI program development and maintenance.

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, it was determined the Agency failed to develop a Quality Assessment Performance Improvement program that selected, performed and documented annual quality improvement projects for the 2019, 2020 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 5-18-21 at 12:45 PM, during an interview, the Agency Owner was asked to provide documentation for the Agency's QAPI (Quality Assessment Performance Improvement) program and Performance Improvement Projects, reasons for conducting the projects along with measurable progress achieved. The Owner was unable to provide the requested documents and stated, "We haven't done any QAPI activities since I bought the agency in 2018. The staff were supposed to start the QAPI program this week, but we don't have anything done for the QAPI program right now."

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 on record review and interview, the Governing Body failed to ensure the agency had an active, functioning and ongoing Quality Assessment and Performance Improvement program that fulfilled all the regulatory requirements of this section, resulting in the potential poor quality of care and negative outcomes for the agency's patients. Findings include: On 5-18-21 at 12:45 PM, during an interview, the Agency Owner was asked to provide documentation showing the Governing Body's approval and oversight of the agency's QAPI (Quality Assessment Performance Improvement) program and the QAPI program documentation. The Owner was unable to provide the requested documents and stated, "We haven't done any QAPI activities since I bought the agency in 2018. The staff were supposed to start the QAPI program this week, but we don't have anything done for the QAPI program right now. I am not sure what you mean by documentation of the governing body, we don't have anything like that." There was no evidence of any data collection, analysis, tracking or implementation of any corrective actions to improve the quality and safety of patient care. There was no documentation of any Governing Body activity/oversight of the QAPI program development and maintenance.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure a governing body assumed responsibility for the operation of the agency, the provision of all home health services and its quality assessment and performance improvement program, resulting in a lack of overall leadership in the agency's provision of home health services (SEE G-942); failed to ensure the Administrator was appointed by and reported to the Governing Body (SEE G-946); failed to ensure that 1 of 1 administrators (Adm#1) employed by the agency, received training, orientation and a background check (SEE G-952); failed to ensure the Alternate Administrator was appointed by and reported to the Governing Body (SEE G-954); failed to provide any services, resulting in the agency not functioning as an operational business (SEE G-984); and failed to ensure clinical records were retrievable and available for surveyor review (SEE G-1030). The systemic effects of the above deficiencies had the potential to affect all patients admitted by the agency, resulting in the potential for substandard care, patients not receiving needed services and the potential for poor patient outcomes.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined the home health agency failed to have an active Governing Body that met at least annually, and assumed full legal authority and responsibility for the agency's overall management and operations, all services provided, the fiscal operations, review of the agency's budget and operations plans and it's quality assessment and performance improvement program, since 2017, resulting in the potential to adversely affect the quality of care to all patients receiving services. Findings include: On 5/18/21 at 10:45 a.m., the Governing Body meeting minutes were requested for review. Upon request of the Governing Body meeting minutes, the owner was unable to produce any Governing Body meeting minutes. There was no documented evidence the Governing Body met, at least annually, was responsible for the overall management and operations of the agency, developed a budget and operations plan that was reviewed annually, and that the quality assessment and performance improvement plan (QAPI) was reviewed at least annually since 2017. The above information was reviewed and acknowledged by the owner, during an interview on 5/18/21 at 11:00 a.m.

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 ensure the Administrator (Adm#1) was appointed by and reported to the Governing Body, resulting in no definitive lines of authority and the lack of oversight of patient care and operations of the agency, affecting all patients admitted to the agency, resulting in the potential for poor patient outcomes. Findings include: On 5/18/21 at 10:45 AM, the owner was asked to provide the Governing Board meeting minutes that reflected Adm#1's appointment. The owner was unable to locate the documentation requested. There was no further documentation provided by the agency by the time of the survey exit on 5/18/21.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure that 1 of 1 administrators (Adm#1) had an orientation or training, resulting in the potential for an unqualified administrator operating the agency. Findings include: On 5/18/21, a review of Adm#1's personnel file revealed there was no documented training or orientation completed. The owner was questioned on 5/18/21 at 11:00 a.m., and agreed with the findings.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on interview, it was determined the Administrator (Adm#1) and the Governing Body failed to identify in writing, an alternate administrator and an alternate Clinical Manager, for a potential lack of oversight and management of patient care services and staff. Findings include: During an interview on 5/18/21 at 11:00 a.m., when queried to provide documentation the alternate administrator and alternate clinical manager were appointed by the governing body, the owner replied, "I do not have that documentation."

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on interview, it was determined the agency failed to provide any services, resulting in the agency not functioning as an operational business. Findings include: During an interview on 5/18/21 at 10:30 a.m., the owner was asked for a current census. The owner stated, "We do not have any active patients. We have only had 1 patient since 2017."

Retrieval of records CFR(s): 484.110(e) Standard: Retrieval of clinical records. A patient's clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first). This STANDARD is not met as evidenced by: Based on interview it was determined that the agency failed to ensure clinical records were retrievable and available for surveyor review for 1 of 1 patients who received services from the agency (MR #1) out of a total sample of 1 patient. Findings Include: MR #1: During an interview on 5-18-20 at 12:20 PM, the owner of the agency was asked to provide record #1 for surveyor review. The owner stated "We are unable to provide access to the clinical record for the patient because we don't have active access to the computer documentation system. We haven't been able to pay to keep the access to the medical records active since we aren't seeing patients. It would cost a lot of money for us to get access back to the record and we don't have the money to pay for it."