Every finding on record at Principal Home Healthcare, LLC

The following condition level deficiency was identified at a Medicare authorized re-certification survey by the Michigan Department of Licensing and Regulatory Affairs on 3/14/23 through 3/17/23 at: Principal Home Healthcare 33469 W 14 Mile Rd., Suite 150 Farmington Hills, MI 48331 The agency had no additional extension sites. At the survey's conclusion, the agency was found to be non-compliant 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: Based on record review and interview, the agency failed to develop an emergency preparedness plan that must be reviewed, updated and included guidance for the Covid-19 pandemic (See E 0004); failed to develop an emergency preparedness plan that must be reviewed and updated at least every 2 years that included guidance for the Covid-19 pandemic and strategies based on documented facility and community based risk assessments from an all hazards approach (See E 0006); failed to develop and update written emergency preparedness policies and procedures that were based on an emergency preparedness plan, risk assessment, and communication plan (See E0013); failed to develop and maintain an emergency preparedness communication plan that is reviewed and updated at least every 2 years and includes contact information for Federal, State, regional, local emergency preparedness staff, and other sources of assistance, (See E 0031); failed to show evidence the emergency preparedness training and testing program is based on the emergency plan, risk assessment, policies, procedures, and the communication plan (See E0036); and failed to perform testing of their emergency preparedness program as required (See E0039). The cumulative effect of these systemic problems could potentially have a negative effect on all four patients serviced by the agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop an emergency preparedness plan that must be reviewed and updated at least every two years and included strategies to address the Covid-19 global pandemic, resulting in no directions for agency personnel in the event of an actual emergency or disaster. This deficient practice could negatively affect the health and safety of all 4 patients currently serviced by this agency in the event of an emergency or disaster. Findings include: On 3/16/23, review of the Agency's Emergency Preparedness (EP) binder revealed no evidence that the Agency's Administrator (Adm.#1) or the Governing Body (GB) had reviewed and updated its Emergency Preparedness (EP) plan since 2018. The GB meeting minutes were also reviewed dating back to 1/24/20, which showed 13 of 13 opportunities when the GB met, no documentation was found that indicated the EP plan was reviewed and updated as required. In addition, the EP program found no documentation that the Agency had developed an EP plan that acknowledged and incorporated strategies how to optimize patient care concerning the Covid-19 pandemic over the last three years. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:12 AM.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility 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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to develop and update Emergency Preparedness (EP) policies and procedures that were based on an EP plan, risk assessment, and communication plan, resulting in the Agency's inability to implement appropriate emergency actions which could negatively affect the health and safety of all patients serviced by the Agency. Findings include: On 3/16/23, review of the Agency's Emergency Preparedness (EP) binder revealed no evidence the Agency's EP's plan and policies had been reviewed since 2018. Additional review noted the Governing Body's (GB) meeting minutes dating back to 1/24/20, found 13 of 13 opportunities failed to acknowledge and incorporate needed updates. For example, no documentation was evidenced of the Agency having developed an EP plan that acknowledged and incorporated strategies how to optimize patient care concerning the Covid-19 pandemic over the last three years. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Director (CM#1) during an interview on 3/17/23 at 11:15 AM.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(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: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan that is reviewed and updated at least every 2 years and includes contact information for Federal, State, regional, local emergency preparedness officials, and other sources of assistance, resulting in a lack of effective communication and coordination in the event of an actual emergency. This deficient practice could affect the health and safety of the agency's 4 current patients in the event of an actual emergency. Findings include: The agency's Emergency Preparedness Plan was reviewed on 3/16/23 at 1:40 PM. During the review, it was noted that there was no documented evidence of a communication plan that includes the contact information for Federal, State, regional, local emergency preparedness staff, and other sources of assistance. There was no documentation to indicate the agency's communication plan was reviewed and updated at least every 2 years. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:17 AM.

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, 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 communication plan, which must be reviewed and updated at least every two years. This deficient practice could affect the health and safety of staff and all 4 patients currently admitted to the agency in the event of an actual emergency. Findings included: On 3/16/23 at 1:45 PM., review of the agency's Emergency Preparedness (EP) binder revealed on 6/17/21, the agency had performed a testing drill based off an actual event (tornado). However, review of the drill's documentation revealed several concerns requiring direction from the agency's Administrator and Governing Body. The testing drill summary documented the following: "Possible problems could be a lack of accountability, such as unclear chains of command, poor communication. There were no staff that could be called to assist the command site. There is no front desk/secretary or other person to assist with calls and protecting charts... Until we obtain adequate staff PHHC will not be able to sustain itself in an emergency." On 8/7/22, another actual event (excessive heat) was documented which was reviewed on 3/16/23 at 1:55 PM. Documentation noted calls were made to patients to stay in the house, usage of fans, and drink fluids. The temperature was documented at 103 with very humid conditions. No documentation was found that indicated the what the status was of any of the patients during or after the heat emergency on 8/7/22. Detailed strategies to address the above concerns and lack of agency staff to sufficiently protect the welfare of its patients by the Administrator and Governing Body were not evidenced. Further, no documentation was found where the agency reviewed and approved the EP orientation program and EP in-services provided by the contracted agencies to its staff. Contracted staff represented all care furnished by the home health agency outside of skilled nursing. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:20 AM.

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 record review and interview, the agency failed to provide documentation to fulfill the requirement of participating in a community based full-scale exercise at least once every two years, resulting in the potential for staff and all 4 patients currently receiving services not to be properly prepared in the event of an actual emergency. Findings include: On 3/16/23 at 1:55 PM., review of the agency's Emergency Preparedness (EP) binder found no evidence the agency had conducted or attempted to participate in the required full-scale community-based exercise every two years. No communication or effort was noted by the agency in reaching out to the local incident command center to find out when and where the next community-based exercise would be. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:22 AM.

On 3/14/23 through 3/17/23, a Medicare re-certification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs at: Principal Home Healthcare 33469 W 14 Mile Rd., Suite 150 Farmington Hills, MI 48331 At the time of the survey, the agency did not operate any branch offices. A total of 7 records were reviewed, with 1 home visit due to low patient census, 4 active records, and 3 discharge records. The following Condition Level deficiencies were identified: 42 CFR §484.60: Care Planning, Coordination, Quality of Care 42 CFR §484.65: Quality Assessment and Performance Improvement (QAPI) 42 CFR §484.70: Infection prevention and control 42 CFR §484.75: Skilled Professional Services. 42 CFR §485.102: Emergency Preparedness. 42 CFR §484.105 Organization and Administration of Services. 42 CFR §484.110: Clinical Records As a result of the Condition level noncompliance found at the 3/17/23 re-certification survey, 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)

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure that 1 (MR #3) of 1 patient observed during home visit, was included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided, from a total of 7 sampled records reviewed, resulting lack of inclusion in planning, the potential for missed visits and unmet care needs. Findings include: MR #3: The patient's start of care was 3/15/23 with diagnoses that included Diabetes Mellitus, Hypertension and Degenerative Joint Disease. During the clinical record review on 3/15/23 at 10:40 a.m., it was noted that referral for home care ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. On 3/15/23 at 12:30 p.m., a scheduled home visit was conducted with the Registered Nurse (RN #1). During the visit, RN #1 stated when she would return for the patient's next in-home visit. RN #1 did not inquire of the patient's preference, schedule or availability for future visits. The visit was concluded without completing a calendar of proposed visits to ensure the patient was included in her overall planning of care. These findings were reviewed with and acknowledged by the Clinical Manager (CM #1) who was present during the home visit, and during a subsequent interview on 3/15/23 at 4:33 p.m.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the patient received proper written Notice of Medicare Provider Non-Coverage in advance of the Agency terminating on-going care for 1 (MR# 1) of 2 discharged records, resulting in the patient being denied the right to appeal the decision to end Medicare covered services. Findings include: MR #1: The patient's start of care was 3/9/22 with diagnoses that included Hypertension, Diabetes Mellitus II, Stroke and Hemiplegia. During the record review on 3/14/23 at 3:50 p.m., it was noted that the plan of care ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The patient discharged from SN on 3/24/22 and discharged from PT and the agency's services on 4/26/22. Further review of the clinical record revealed that the patient was informed that "Services will end on 4/7/22", however, the Notice of Medicare Provider Non-Coverage was provided and signed by the patient on 4/26/22. This resulted in the patient being ill-advised, within the required time, of his rights to appeal the decision to end services. The Agency failed to ensure the patient received proper written Notice of Medicare Provider Non-Coverage. These findings were reviewed with and acknowledged by the Administrator (Adm #) and Clinical Manager during an interview on 3/16/23 at 12:26 p.m.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the comprehensive assessment accurately reflected the patient's current health status at the time of admission for 2 (MR #1 and 5) records, from a total of 7 sampled records reviewed, resulting in incomplete clinical information to aide in determining the needs of the patient and for measuring the patient's progress toward goals. Findings include: MR #1: The patient's start of care was 3/9/22 with diagnoses that included Hypertension, Diabetes Mellitus, Stroke and Hemiplegia. The referral for home care ordered Skilled Nursing and Physical Therapy services to be provided. On 3/14/23 at 3:50 p.m., the Initial comprehensive Assessment dated 3/9/22, completed by the Registered Nurse revealed the following: Sections M1021/M1023 listed diagnoses that included Diabetes Mellitus, Hemiplegia, Muscle Weakness, Essential Hypertension, Long Term use of Hypoglycemic drugs and Osteoarthritis. The assessment indicated that all the listed diagnoses had an exacerbation date of 3/7/22. This was an inaccurate reflection of the patient's health status at the time of admission. The section titled Supportive Assistance failed to identify the patient's caregiver. The Assessment failed to accurately reflect the patient's health status at the time of admission. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/16/23 at 12:26 p.m. MR #5: The patient was admitted to home care on 2/11/23 with diagnoses that included COPD (Chronic Obstructive Pulmonary Disease), Dependence on Supplemental Oxygen, Diabetes-Type 2, and Hypertension. On 3/15/23, review of the initial Comprehensive Assessment noted 9 of 9 listed diagnoses all had an exacerbation date of 2/11/23. Further review of the medical record found these dates to be inaccurate. In addition, the primary diagnoses listed above failed to document the patient's past medical history with correct dates of onset, exacerbations, treatments/outcomes, and baseline data. No information concerning the patient's level of need to appropriately manage the above diagnoses were found within the initial assessment, and the events which led to the admission to home health services. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/17/23 at 11:47 AM.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure the patient's Activity of Daily Living needs, Speech Therapy and Medical Social Work needs were adequately met in the patient's home for 1 (MR #1) patient who required the needed services, from a total of 7 sampled records reviewed, resulting in the potential for poor hygiene, physiological decline, lack of resources, and unmet care needs. Findings include: MR #1: The patient's start of care was 3/9/22 with diagnoses that included Hypertension, Diabetes Mellitus, Stroke and Hemiplegia. During the clinical record review on 3/14/23 at 3:50 p.m., it was noted that the referral for home care dated 3/8/22 ordered Skilled Nursing (SN) and Physical therapy (PT) services to be provided. Section M1033 (Risk for Hospitalization) of the Initial Comprehensive Assessment dated 3/9/22, completed by the Clinical Manager (CM #1) documented, "Patient accumulates a large amount of secretions in his mouth making it difficult to speak, coughs with gurgling sound." Section M1100 (Community Agencies/Social Service Screening) documented, "MSW/Medical Social Work referral indicated for community resources. Section M1800 (Grooming) documented, "Someone must assist patient to groom self, put on upper body clothing, undergarments, slacks..." Further review of the clinical record revealed no provision of Speech Therapy services, Medical Social Work or Home Health Aide services had been provided on offered in order to meet the needs of the patient. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and CM #1 during an interview on 3/16/23 at 12:26 p.m. CM #1 responded, "Those services should have been provided."

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Initial Comprehensive Assessment reflected the person(s) availability and willingness to assist 1 (MR #1) of 1 patient with overall care needs, including grooming, from a total of 7 sampled patients reviewed, resulting in the potential for unsupported care, poor hygiene, and unmet care needs. Findings include: MR #1: The patient's start of care was 3/9/22 with diagnoses that included Hypertension, Stroke with Hemiplegia, and Diabetes Mellitus. During the clinical record review on 3/14/23 at 3:50 p.m., it was noted that the plan of care ordered Skilled Nursing and Physical Therapy services to be provided. Section M1800 of the Initial Comprehensive Assessment dated 3/9/22 documented the patient required assistance with grooming. The section titled "Functional Limitations" indicated the patient had paralysis, difficulty breathing, incontinence, and had difficulty speaking due to a large accumulation of fluid in his mouth. Section M1100 (Supportive Assistance) failed to identify the person(s) who would be available and willing to provide assistance with the patient's overall care needs. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/16/23 at 12:26 p.m.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, record review and interview, it was determined that the Agency failed to provide care and services in accordance with the plan of care in 2 (MR#'s 6, 7) records, from a total sample of 7 records reviewed (See G 572); failed to ensure that all care and services were provided only in accordance with the physician's orders for 1 (MR #2) of 1 patient who was recertified for additional services, from a total of 7 sampled records reviewed (See G 580); failed to ensure verbal orders were written into the medical record and furnished in 2 (MR#'s 4, 5) records, from a total sample of 7 records reviewed (See G 584); failed to ensure the physician was promptly notified of a patient's change in condition in 2 (MR#'s 3, 4) records who displayed clinical findings outside of ordered safety parameters, from a total of 7 records reviewed (See G 590); and failed to coordinate and facilitate care as ordered by the physician in 1 (MR#4) record, from a total sample of 7 records reviewed (See G 608). The cumulative effect of these systemic problems resulted in the home health agency's Immediate Jeopardy and inability to ensure the provision of quality health care for the condition of participation of 42 CFR 484.60: Care Planning, Coordination of Services, and Quality of Care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to provide care and services in accordance with the plan of care in 2 (MR#'s 6, 7) records, from a total sample of 7 records reviewed, resulting in the potential for decline in physical functioning and unmet care needs. Findings include: MR#6: The start of care date was 7/2/22 with diagnoses which included poly-osteoarthritis, muscle weakness, hypertension, and diabetes-type 2. On 3/16/23, record review noted the Plan of Care (POC) ordered Physical Therapy (PT) to provide a visit frequency of 1W1, followed by 2W4 (twice a week times 4 weeks. Further review found that PT had failed to provide services as ordered. Weeks 3, 4, and 5 each only had one visit provided, not the ordered twice a week. There was no documentation that the patient or caregiver had declined or delayed PT services and no documentation to indicate the physician was informed that PT services were not provided as ordered. The above findings were reviewed with the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 10:55 AM., both acknowledging that PT should have documented the reasons for the missed visits and notified the physician. MR#7: The start of care date was 12/1/22, with diagnosis that included back pain, insulin dependent diabetes, and hypertension. Record review on 3/16/23 noted the patient was hospitalized for heart related issues on 12/13/23 with a resumption of care (ROC) dated 12/16/23. Skilled Nursing (SN) on 12/16/23, documented under "Orders for Discipline and Treatments" for SN to perform visits as 1W1, 3W2. Under "Skilled Intervention", SN documented the physician was contacted concerning visit frequency (noted above), and other health related items. Review of the record noted that SN only performed 2 of 3 ordered visits each of the first two weeks after hospital discharge. There was no documentation that the patient or caregiver had declined or delayed SN services and no documentation to indicate the physician was informed that SN services were not provided as ordered. These findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:42 AM.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure that all care and services were provided only in accordance with the Physician's orders for 1 (MR #2) of 1 patient who was recertified for additional services, from a total of 7 sampled records reviewed, resulting in the provision of unauthorized unsafe care and services and poor patient outcomes. Findings included: MR #2: The patient's start of care was 6/5/20. The certification period of review was 1/20/23 through 3/16/23 with diagnoses that included Hemiplegia, Stroke, Hypertension, Aphasia and Muscle Weakness. During the clinical record review on 3/16/23 at 10:45 a.m., it was noted that the patient was ordered to receive Physical Therapy (PT) services at a frequency of 1x/wk. x 1 wk., 2x/wk. x 8 wks. The PT recertified the patient for additional services and completed the Recertification Comprehensive Assessment/Oasis on 1/18/23. A Physician's order, drafted by the Physical Therapist (PT #1) was dated 1/18/23 and documented, "Physician order to recert patient for skilled Physical Therapy/Occupational Therapy/Speech Therapy in order to maintain progress made during and for functional maintenance program." The Physician's order was void of a signature that authorized the above services to be rendered. Additionally, no signed Physician's order, had been made available for review by the survey's end. The Agency failed to ensure that all care and services were provided only in accordance with Physician's orders. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/16/23 at 1:40 p.m.

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency's skilled nursing (SN) and administrative services failed to coordinate and facilitate care as ordered by the physician in 2 (MR#'s 4, 5) records, from a total sample of 7 records reviewed, resulting in the failure of verbal orders being entered into the medical record and the potential for unmet clinical which could negatively impact all 4 patients currently admitted. Findings include: MR#4: The patient was admitted to the home care agency on 7/21/22 with diagnoses which included (COPD) chronic obstructive pulmonary disease, hypotension, and back pain. On 3/17/23, record review noted SN and Physical Therapy (PT) had 11 of 11 visits from 7/21/22 through 8/13/22 which documented the patient being on 5 Liters of oxygen with recorded saturation levels between 97% and 100%. Further review noted no orders in the Plan of Care POC) for any supplemental oxygen and coordination of care notes were not evidenced in the medical record throughout admission. On 3/17/23 at 0950 AM., the Clinical Manager (CM#1) was queried about the dangers of too much oxygen being delivered to a patient with COPD (suppresses the desire to breath which leads to hypercapnia (excessive carbon dioxide/waste product in the blood), putting the patient's health in danger. CM#1 reviewed the POC and patient orders and acknowledged no oxygen orders were written. CM#1 then pulled her phone out and displayed a text message to the surveyor from the physician on 8/6/22, directing SN to lower the oxygen to 2-3 Liters and keep oxygen saturation levels between 92%-94%. No evidence was found in the medical record of SN communicating this finding or writing a verbal order, which allowed PT services to furnish care against the physician's directive. When CM#1 was further queried why excessive supplemental oxygen of 4-5 Liters had continued throughout the certification period and why no documented patient education was found in the clinical record, CM#1 offered no response. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:42 AM. MR#5: The patient was admitted to the home care agency on 2/11/23 with diagnoses which included diabetes-type 2, hypertension, chronic obstructive pulmonary disease, and dependance on supplemental oxygen. On 3/16/23, review of the referral for home care noted the effective date as 2/14/23, 3 days after the patient had received services for the agency. The Administrator (Adm.#1) was queried at 2:40 PM., how this was possible. Adm.#1 after reviewing the medical record and her phone, the following was revealed at 3:15 PM. A physician text was found on 2/10/23 which directed the agency to admit the patient on 2/11/23. Adm.#1 acknowledged the agency failed to enter the verbal order into the medical record. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:44 AM.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to provide documented evidence to ensure the plan of care was reviewed and revised by the Physician for 1 (MR #2) of 1 patient who was recertified for additional home care services, from a total of 7 sampled records reviewed, resulting in the potential for the patient not receiving needed care and services based on the identified individualized needs. Findings include: MR #2: The patient's start of care was 6/5/20. The certification period of review was 1/20/23 through 3/16/23 with diagnoses that included Hemiplegia, Stroke, Hypertension, Aphasia and Muscle Weakness. During the clinical record review on 3/16/23 at 10:45 a.m., it was noted that the patient was ordered to receive Physical Therapy (PT) services at a frequency of 1x/wk. x 1 wk., 2x/wk. x 8 wks. The PT recertified the patient for additional services on 1/18/23. Upon further review, there was no documented evidence that the Physician had been in receipt of a summary that detailed the course of care provided and the status of the patient at the end of the certification period. Subsequently, there was no evidence provided to the Physician to initiate a review and revision of the plan of care. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Clinical Manger (CM #1) during an interview on 3/16/23 at 1:40 p.m.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure the Physician was promptly notified of the patient's change in condition for 2 (MR#'s 3, 4) patients who displayed clinical findings outside of ordered safety parameters, from a total of 7 sampled records reviewed, resulting in the potential for unidentified, unaddressed health concerns and unmet health care needs. Findings include: Policy: "Vital Sign Parameters" Rev. 10/28/19 stated, "The following quantitative vital signs shall be used as a guide when to contact the physician. Blood Pressure is above 160/90..." MR #3: The patient's start of care was 3/15/23 with diagnoses that included Diabetes Mellitus, Hypertension, Degenerative Joint Disease, and bilateral Footdrop. During the record review on 3/15/23 at 10:40 a.m., it was noted that the referral for home care ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The referral paperwork also indicated the patient had an indwelling catheter (Foley) due to urinary retention. On 3/15/23 at 12:30 p.m. a scheduled home visit was conducted with the Registered Nurse (RN #1) and the Clinical Manager (CM #1). During the visit, RN #1 checked the patient's blood pressure which read 178/100. RN #1 removed the cuff and replaced it on the same arm and got a reading of 175/78. There was no documented evidence that the Physician had been promptly notified of the patient's elevated blood pressure readings, by the end of the survey and in accordance with the Agency's policy. These findings were reviewed with and acknowledged by the and CM #1 during an interview on 3/16/23 at Policy: "Vital Sign Parameters" Rev. 10/28/19 stated, "Oxygen...or the sat (saturation) is below 93, the physician must be notified. Any difficulty breathing call 911." MR#5: The patient was admitted to the home care agency on 2/11/23 with diagnoses which included diabetes-type 2, hypertension, chronic obstructive pulmonary disease, and dependance on supplemental oxygen. On 3/16/23, review of the clinical record noted the patient was on 2-3 Liters of supplemental oxygen and had 8 of 8 entries (2/11/23 to 3/8/23) where the patient's saturation level was normal at 96-97%. However, on day of discharge (3/10/23) from Physical Therapy (PT) services, the patient's saturation level was documented as being 98% pre-therapy and 87% post-therapy by PT services. No recheck of this result was found in the record and no physician notification of the above finding was evidenced. The above findings were reviewed with the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 10:53 AM. Both acknowledged the PT should have rechecked the result and notified the physician.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency's skilled nursing (SN) services failed to coordinate and facilitate care as ordered by the physician in 1 (MR#4) record, from a total sample of 7 records reviewed, resulting in the patient's inability to receive ordered services. This deficient practice could negatively impact all 4 patients currently admitted. Findings include: MR#4: The patient was admitted to the home care agency on 7/21/22 with diagnoses which included (COPD) chronic obstructive pulmonary disease, hypotension, and back pain. On 3/17/23, record review noted SN and Physical Therapy (PT) had 11 of 11 visits from 7/21/22 through 8/13/22 which documented the patient being on 5 Liters of oxygen with recorded saturation levels between 97% and 100%. Further review noted no orders in the Plan of Care POC) for any supplemental oxygen and coordination of care notes were not evidenced in the medical record throughout admission. On 3/17/23 at 0950 AM., the Clinical Manager (CM#1) was queried about the dangers of too much oxygen being delivered to a patient with COPD (suppresses the desire to breath which leads to hypercapnia (excessive carbon dioxide/waste product in the blood), putting the patient's health in danger. CM#1 reviewed the POC and patient orders and acknowledged no oxygen orders were written. CM#1 then pulled her phone out and displayed a text message to the surveyor from the physician on 8/6/22, directing SN to lower the oxygen to 2-3 Liters and keep oxygen saturation levels between 92%-94%. No evidence was found in the medical record of SN communicating this finding or writing a verbal order, which allowed PT services to furnish care against the physician's directive. When CM#1 was further queried why excessive supplemental oxygen of 4-5 Liters had continued throughout the certification period and why no documented patient education was found in the clinical record, CM#1 offered no response. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:42 AM.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to include contact information for the Home Health Agency's Clinical Manager in the Patient Admission/Orientation Packet, resulting in the potential for unaddressed patient concerns. Findings include: On 3/15/23 at 3:10 p.m., the Agency's Admission packet was reviewed. The packet included a consent form, admission agreement, Beneficiary notice and patient rights and responsibilities forms and Emergency Preparedness documents. Upon review, it was noted that there was no contact information for the Agency's Clinical Manager. These findings were reviewed with and confirmed by the Administrator (Adm #1) during an interview on 3/16/23 at 11:05 a.m.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to develop a Quality Assessment and Performance Improvement (QAPI) program that measured, tracked, and analyzed its quality indicators in order to quantitatively assess outcomes concerning care and services furnished by the Agency (See G 642); failed to provide data collected which monitored the QAPI program to determine the effectiveness, safety of services, and quality of care to identify opportunities for improvement (See G 644); failed to document any quality improvement projects for 2019 through 2023 to date, and document the reasons for conducting these projects and the measurable progress achieved each year (See G 658); and failed to ensure the Governing Body had appropriate over-sight that ensured an effective means to comprehensively evaluate the Agency's QAPI program (See G 660). 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 has served 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 4 patients serviced by the agency, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: The Agency's QAPI documentation binder was reviewed on 3/16/23. During review, documentation to support the Agency's performance improvement activities regarding their efforts to systematically collect data, monitor, analyze and improve patient outcomes was not found. The QAPI binder contained documentation and instructions for a QAPI program but had no documentation noted for the years 2020 and 2021. In 2022, the only documentation of an indicator was patients being on antibiotics. However, no meaningful collection of data with the ability to show measurable improvement designated towards pre-established patient safety and quality of care measures was not evidenced. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:25 AM.

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 (QAPI) program, which had the potential to negatively affect all 4 patients currently serviced by this Agency, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: During the review of the agency's QAPI program activities in 2020 and 2021, it was noted that the agency failed to produce any data that could be measured, tracked, or analyzed. In 2022, documentation of patients being on antibiotics was noted, however there was no evidence the agency's governing body had approved the frequency and detail of the data collection within the QAPI program. Further, the agency failed to develop and utilize specific data elements collected to identify opportunities for improvement concerning safety of services and quality of care for the last three years. The above findings were reviewed with and acknowledged by the Administrator and the Clinical Manager during an interview on 3/17/23 at 11:27 AM.

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 record review and interview, it was determined the Agency failed to develop a Quality Assessment Performance Improvement (QAPI) program that documented the annual performance improvement projects, and the reasons for conducting these projects with measurable progress achieved, resulting in the Agency's inability to show improvement in areas concerning quality of patient care, health outcomes, and patient safety. Findings include: On 3/16/23, review of the Agency's QAPI program activities for 2020 and 2021, noted the Agency failed to develop any performance improvement projects (PIP) concerning the Agency or patient care related items. In 2022 through date of review, the only documentation of a potential PIP was 8 patients over 3 months being on antibiotics. However, no evidence was found which documented the reasons why this was chosen, and evidence of measurable progress achieved concerning the patients on antibiotics was not found. Review of the agency's governing body meeting minutes from 2020 through date of review, found no documentation that acknowledged the need for a QAPI program or maintaining any of its required elements. The above findings were reviewed with and acknowledged by the Administrator and the Clinical Manager during an interview on 3/17/23 at 11:29 AM.

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, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all 4 patients serviced by this Agency. Findings include: On 3/16/23, a request was made to review the Agency's QAPI report and Governing Body (GB) meeting minutes from 2020 through date of review. Upon receipt and review of the Agency's QAPI binder and all GB documentation, no evidence was found that acknowledged the need for a QAPI program or maintaining any of its required elements since 2020. The above findings were reviewed and acknowledged by the Administrator and the Clinical Manager during an interview on 3/17/23 at 11:31 AM.

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, it was determined the agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases that was incorporated into the Quality Assessment/Performance Improvement program (G-684); failed to provide documented evidence that infection control education was provided to all staff employed by the agency and who were granted clinical privileges, resulting in the potential for the development and spread of infection (G-686); and failed to provide documented evidence to support that all staff employed by this agency and those who had been granted clinical privileges, had been vaccinated against the Covid-19 virus (G-687). 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 develop and maintain a coordinated agency-wide program for the surveillance, identification, prevention, and control of infectious diseases including COVID-19; failed to develop a method to screen visitors and agency staff prior to providing clinical services, and failed to develop an infection control program that is incorporated into the agency's QAPI (Quality Assurance & Performance Improvement) program in order to track and trend the risk factors focused on the containment of Covid-19 and other communicable diseases, resulting in the potential development and spread of a contagious viral infection between Agency staff and all patients serviced by the Agency. Findings included: The Agency's infection control program was reviewed on 3/16/23. Documentation which represented the agency's efforts to maintain its Infection Control (IC) program were noted as follow: No patient infections from 2020 through July 2022. The Director of Clinical Services (DCS#1) documented, "Antibiotics were given to several patients used as prophylactic, most of the patients were surgical. All COVID standards/isolation was in place and maintained with home care staff." No evidence was found of how or to what extent the methodology used to determine if the above statements by DCS#1 met accepted standards of practice concerning infection control, including COVID-19. In addition, several "Infection Control" sheets were reviewed, which documented only if a patient was on an antibiotic or not. A "Clinical Record Review Tool" was found to be undated and blank. Another sheet titled "Annual Field Visits" for 2020 through 2022 was found to be blank. The only IC data found was 7 entries of hand hygiene/glove use noted on 1/13/21 through 2/9/21, which had no pre-designated purpose identified within the agency's IC program. Another sheet titled, "Infection Control Approval" (7/13/2020) was signed by the Administrator, DCS#1, and the President of the agency. However, no accompanying documentation was found which detailed what the signed approval was agreeing to. Documented screening procedures used to mitigate the spread of Covid-19 and other infectious diseases among clinical staff and patients was not found within the IC program or any agency policy or procedures. During an interview on 3/17/23 at 11:27 AM., the above findings were reviewed by the Administrator and the Director of Clinical Services. It was acknowledged the agency failed to show an IC program that maintained the ongoing surveillance, systemic collection, analysis, interpretation, and evaluation of IC data that incorporated all disciplines involved in patient care.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency failed to provide evidence of infection control education concerning Covid-19 and other communicable disease was provided to any staff employed by the agency, resulting in the potential for the development and spread of the Covid-19 and other infectious agents to staff and all 4 patients currently serviced by the agency. Findings include: On 3/16/23, the Administrator (Adm.#1) was queried about documentation of staff training, education, and in-services' regarding infection control (IC), including COVID-19. Adm.#1 submitted personnel files of staff from 3 of 3 contracted agencies. Review of the documentation within the personnel files noted 4 of 4 staff had a checked box signifying the clinician had been "educated" on IC. Adm.#1 was then asked if the agency had ever reviewed or received a copy of the content each clinician was trained, educated, or in-serviced on. Adm.#1 replied, "No." Adm.#1 then acknowledged the agency had no way of knowing to what extent any of the contracted staff, which represented all care provided to patients outside of nursing, had received concerning infection control education, including Covid-19. The above findings were reviewed with and acknowledged by the Administrator and the Director of Clinical Services at the time of discovery on 3/16/23 at 3:10 PM.

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 the requirement for all staff to be fully vaccinated against the covid-19 virus; (iii) implementation of additional precautions to mitigate the transmission and spread of Covid-19; (vii) a process for tracking/documenting information provided by staff who have requested/been granted an exemption from the Covid-19 requirements; (x) Contingency plans for staff who are not fully vaccinated for Covid-19, 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 3/15/23 at 9:00 the Clinical Manager (CM #1) was asked for permission to review the Agency's Vaccine policy. At 9:30 a.m., CM #1 reported, "I can't find it." At 10:00 a.m. CM #1 reported, "I had it. I made a copy for you, but I don't know where I put it. I copied where is offers the vaccine to staff." [sic] At 10:08 a.m., the Administrator (Adm #1) questioned, "Policy? I mean we have a policy that says staff must be vaccinated so I'll get that for you. We haven't put together a policy for the Covid-19 vaccine." Adm #1 later presented a policy for the Influenza vaccine and the Hepatitis B vaccine. At 11:35 a.m., a request was made to review select staff's vaccine cards to which Adm #1 responded, "If they took the (Covid-19) vaccine, I would have their card, because it was optional." On 3/15/23 at 3:10 p.m., 4 of 7 personnel files reviewed had not been vaccinated against Covid-19. By the end of the day on 3/16/23, no Covid-19 Vaccine policy had been provided. These findings were reviewed with and acknowledged by Adm #1 and CM #1 at the time of discovery.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on observation and interview, the Registered Nurse failed to utilize professional standards of practice during the provision of care and services for 1 (MR #3) of 1 patient observed during a home visit, from a total of 7 sampled records reviewed, resulting in patient inconvenience, inaccurate patient assessment and the potential for unmet care needs (G704); failed to ensure the Registered Nurse performed baseline assessments and re-assessments of the patient's health status and needs in 1 (MR #1) record of a patient with a diagnosis of Diabetes Mellitus, and 1 (MR #3) of 1 patient observed during a home visit, from a total of 7 sampled records reviewed, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes (G706); and, failed to ensure the clinical record was completed and included detailed Physical Therapy notes for 1 (MR #2) record with the ordered services, from a total of 7 sampled records reviewed, resulting in the potential for undocumented, unidentified health concerns, and unmet patient care needs (G716). The cumulative effects of this systemic problem resulted in the Home Health Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation: 42 CFR 484.75 Skilled Professional Services.

Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This STANDARD is not met as evidenced by: Based on observation and interview, the Registered Nurse failed to utilize professional standards of practice during the provision of care and services for 1 (MR #3) of 1 patient observed during a home visit, and failed to ensure the Registered Nurse coordinated care as directed by the physician in 1 (MR#4) record, from a total sample of 7 records reviewed, resulting in patient inconvenience, inaccurate patient assessment and the potential for unmet care needs. Findings include: MR #3: The patient's start of care was 3/15/23 with diagnoses that included Diabetes Mellitus, Hypertension, Degenerative Joint Disease, and bilateral Footdrop. During the record review on 3/15/23 at 10:40 a.m., it was noted that the referral for home care ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The referral paperwork also indicated the patient had an indwelling catheter (Foley) due to urinary retention. On 3/15/23 at 12:30 p.m., during a scheduled home visit with the Registered Nurse (RN #1) and the Clinical Manager (CM #1), the patient was noted to have bilateral lower extremity edema, with the left leg being more edematous. RN #1 proceeded to measure the patient's legs with use of a paper tape measure. RN #1 measured the patient's leg just under the knee, then moved the tape measure slightly downward, and again, moved the tape measure slightly above the patient's ankles. When queried at to the unit of measurement used, RN #1 stated, "I used inches." RN #1 then forgot the patient's measurements and inquired of this writer for the readings. CM #1 did not assist RN #1 with measuring the patient's edema. CM #1 then informed RN #1 that the measurements were taken incorrectly and should have been obtained using centimeters. RN #1 then told the patient, "I'll have to measure your legs again." The patient was observed to be irritated with this process. RN #1 then proceeded to re-measure the patient's legs, however, did not measure the patient's calf, ankle, and instep in accordance with professional standards of practice. The measurements only included different areas of the patient's upper legs. During the visit, RN #1 used a battery-operated automated blood pressure machine to check the patient's blood pressure which read 178/100. RN #1 removed the cuff and replaced it on the same arm and got a reading of 175/78. RN #1 failed to assess the patient's blood pressure with a manual blood pressure cuff in order to ensure the readings were accurate. Additionally, RN #1 failed to obtain blood pressure readings on the opposite extremity in accordance with professional standards. RN #1 failed to provide care and services in accordance with professional standards of practice. These findings were reviewed with and acknowledged by CM #1 at the time of discovery and in a subsequent interview on 3/15/23 at 4:33 p.m. who reported, "Today was her first day with this Agency. We usually go over things and then she (RN #1) performs the tasks. I should have taken over and performed the assessment myself because you are supposed to use centimeters and measure the patient's calves, ankle, and instep. MR#4: The patient was admitted to the home care agency on 7/21/22 with diagnoses which included (COPD) chronic obstructive pulmonary disease, hypotension, and back pain. On 3/17/23, record review noted SN and Physical Therapy (PT) had 11 of 11 visits from 7/21/22 through 8/13/22 which documented the patient being on 5 Liters of oxygen with recorded saturation levels between 97% and 100%. Further review noted no orders in the Plan of Care POC) for any supplemental oxygen and coordination of care notes were not evidenced in the medical record throughout admission. On 3/17/23 at 0950 AM., the Clinical Manager (CM#1) was queried about the dangers of too much oxygen being delivered to a patient with COPD (suppresses the desire to breath which leads to hypercapnia (excessive carbon dioxide/waste product in the blood), putting the patient's health in danger. CM#1 reviewed the POC and patient orders and acknowledged no oxygen orders were written. CM#1 then pulled her phone out and displayed a text message to the surveyor from the physician on 8/6/22, directing SN to lower the oxygen to 2-3 Liters and keep oxygen saturation levels between 92%-94%. No evidence was found in the medical record of SN communicating this finding or writing a verbal order, which allowed PT services to furnish care against the physician's directive. When CM#1 was further queried why excessive supplemental oxygen of 4-5 Liters had continued throughout the certification period and why no documented patient education was found in the clinical record, CM#1 offered no response. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:42 AM.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the Agency failed to ensure the Registered Nurse performed baseline assessments and re-assessments of the patient's health status and needs in 1 (MR #1) record of a patient with a diagnosis of Diabetes Mellitus, and 1 (MR #3) of 1 patient observed during a home visit, from a total of 7 sampled records reviewed, resulting in the potential for unidentified health concerns, decline in physical functioning, and poor patient outcomes. Findings included: On 3/14/23 at 2:54 p.m., the Entrance Conference was conducted with the Administrator (Adm #1) and the Clinical Manager (CM #1). When queried about the Agency's process for assessing the patient's blood sugars, CM #1 responded, "Most patients get them (glucometer unit) through their Physician, or we try to get them. If they don’t have one, I will use my own. I just use a different lancet in order to maintain infection control precautions. MR #1: The patient's start of care (SOC) was 3/9/22 with diagnoses that included Hypertension, Diabetes Mellitus, Stroke and Hemiplegia. During the record review on 3/14/23 at 3:50 p.m., it was noted that the plan of care (POC) ordered Skilled Nursing (SN) services to be provided. Upon review of the Initial Comprehensive Assessment dated 3/9/22, there was no documented baseline blood sugar. Further review of the SN visit notes dated 3/11/22, 3/15/22, 3/17/22 and 3/24/22, revealed that the SN failed to assess and document the patient's blood sugars. The patient was subsequently discharged from SN services on 3/24/22. At the time of this review, no assessment of the patient's blood sugars had been performed throughout the course of care. These findings were reviewed with and acknowledged by CM #1 during an interview on 3/14/23 at 4:30 p.m. and again on 3/16/23 at 12:26 p.m. with Adm #1 present. MR #3: The patient's SOC was 3/15/23 with diagnoses that included Diabetes Mellitus, Hypertension, Urinary Retention and Bilateral Footdrop. During the record review on 3/15/23 at 10:40 a.m., the referral documents revealed the patient had a history of low blood sugar and kidney problems, was bedbound and had an indwelling urinary catheter (Foley). On 3/15/23 at 12:30 p.m., a scheduled home visit was conducted with the Registered Nurse (RN #1) and the Clinical Manager (CM #1). During the visit, the following was observed: RN #1 failed to assess the patient's respiratory rate, bowel sounds, skin, Foley catheter and its insertion site. During the visit, RN #1 used a battery-operated automated blood pressure machine to check the patient's blood pressure which read 178/100. RN #1 removed the cuff and replaced it on the same arm and got a reading of 175/78. RN #1 failed to assess the patient's blood pressure with a manual blood pressure cuff in order to obtain an accurate reading. Additionally, RN #1 was uncertain as to what unit of measurement (inches or centimeters) was to be used when measuring the patient's identified edema of her bilateral legs. CM #1, who was close by, failed to ensure the patient's lower extremity edema was accurately assessed. These findings were reviewed with and acknowledged by CM #1 at the time of discovery and again on 3/15/23 at 4:33 p.m. with Adm #1 present. CM #1 responded, "I should have took [sic] over to make sure the assessment was done properly."

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the clinical record was completed and included detailed Physical Therapy notes for 1 (MR #2) record with the ordered services, from a total of 7 sampled records reviewed, resulting in the potential for undocumented, unidentified health concerns, and unmet patient care needs. Findings include: Policy: "Medical Record Protection and Retention" 2018 stated, "Agency must maintain a clinical record containing past and current information for every patient..., Patient records contain, at a minimum: Clinical progress notes; All interventions, including medication administration, treatments, and services..." MR #2: The patient's start of care was 6/5/20. The certification period of review was 1/20/23 through 3/16/23 with diagnoses that included Hemiplegia, Stroke, Hypertension, Aphasia and Muscle Weakness. During the clinical record review on 3/16/23 at 10:45 a.m., it was noted that the patient was ordered to receive Physical Therapy (PT) services at a frequency of 1x/wk. x 1 wk., 2x/wk. x 8 wks. The PT recertified the patient for additional services on 1/18/23. Upon review of the clinical record, the PT last saw the patient on 2/17/23. There were no further documented visits from 2/17/23 to 3/16/23. Additionally, no PT visit notes had been produced for the above timeframe by the end of this survey. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/16/23 at 1:40 p.m.

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 interview, the Agency failed to ensure a qualified alternate, was authorized in writing by the Administrator and the Governing Body, to function in the Administrator's absence, resulting in the potential for uncoordinated Agency functions (G954); the Clinical Manager failed to ensure patient care was coordinated to receive the required and ordered Physical Therapy services for 1 (MR #2) of 1 patient with diagnoses of paralysis and muscle weakness, from a total of 7 sampled records reviewed, resulting in patients not receiving care based on their individualized plan of care and unmet care needs (G962); the Clinical Manager failed to ensure the patient's needs were continually assessed for 1 (MR #1) of patient who required glucose monitoring; and 1 (MR #3) patient observed during a home visit, who required skilled services and ongoing assessments, from a total 7 sampled records reviewed, resulting in lack of assurance that assessments are performed in accordance with the patient's needs and the potential for physical decline (G966). The cumulative effects of this systemic problem resulted in the Home Health Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation: 42 CFR §484.105 Organization and Administration of Services.

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, the Agency failed to ensure a qualified alternate, was authorized in writing by the Administrator and the Governing Body, to function in the Administrator's absence, resulting in the potential for uncoordinated Agency functions. Findings include: On 3/16/23, the Administrator (Adm #1) was asked to provide documented evidence of the Governing board's appointment of an Alternate Administrator, however, was unable to do so and responded, "We only have a letter appointing me as the Administrator and a letter appointing the Clinical Manager." There was no evidence provided that delegated an Alternate Administrator in the absence of the Administrator. These findings were reviewed and acknowledged by Adm #1 at the time of discovery.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on record review and interview, the Clinical Manager failed to ensure patient care was coordinated to receive the required and ordered Physical Therapy services for 1 (MR #2) of 1 patient with diagnoses of paralysis and muscle weakness, from a total of 7 sampled records reviewed, resulting in patients not receiving care based on their individualized plan of care and unmet care needs. Findings include: Policy: "Patient Care Coordination", 2018 stated, "The Clinical Manager and/or Rehab Supervisor communicate with staff daily to discuss changes in: The patient's condition, the plan of care, the Physician's orders." Job Description: "Clinical Manger" 2018 stated, "Clinical Manger oversight includes: Patient and personnel assignments, Coordination of Care, Coordination of Referrals, Assuring patient needs are continually assessed and Ensuring the plan of care is developed, implemented and updated for individualized plan of care." MR #2: The patient's start of care was 6/5/20. The certification period of review was 1/20/23 through 3/16/23 with diagnoses that included Stroke, Hypertension, Aphasia (unable to communicate effectively) and Muscle Weakness. The plan of care ordered Speech Therapy (ST), Occupational Therapy (OT) and Physical Therapy (PT) services to be provided. During the record review on 3/16/23 at 10:45 a.m., it was noted that PT last saw the patient on 2/17/23. There were no further documented visits made at the time of this review. The record reflected the patient had been without PT services x 4 weeks. Further review revealed no communication/coordination notes documenting the status of patient care. It could not be decerned whether the patient was to continue with PT services or discharged from the service. The Clinical Manager failed to ensure patient care was coordinated in accordance with this requirement. These findings were reviewed with and acknowledged by the Administrator and Clinical Manager during an interview on 3/16/23 at 1:40 p.m., to which the Administrator responded, "He (PT #1) hasn't completed his visit notes."

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on observation, interview and record review, it was determined that the Clinical Manager failed to ensure the patient's needs were continually assessed for 1 (MR #1) of patient who required glucose monitoring; and 1 (MR #3) patient observed during a home visit, who required skilled services and ongoing assessments, from a total 7 sampled records reviewed, resulting in lack of assurance that assessments are performed in accordance with the patient's needs and the potential for physical decline. Findings include: Job Description: "Clinical Manger" 2018 stated, "Clinical Manger oversight includes: Patient and personnel assignments, Coordination of Care, Coordination of Referrals, Assuring patient needs are continually assessed and Ensuring the plan of care is developed, implemented and updated for individualized plan of care." MR #1: The patient's SOC was 3/9/22 with diagnoses that included Diabetes Mellitus, Hypertension and Stroke with Hemiplegia. During the record review on 3/14/23 at 3:50 p.m., it was noted that the POC ordered Skilled Nursing (SN) and Physical Therapy (PT) services to be provided. The "Endocrine" section of the Initial Comprehensive Assessment dated 3/9/22, completed by the Clinical Manager (CM #1) was void of a baseline blood sugar. Further review of the SN visit notes dated 3/11/22, 3/15/22, 3/17/22 and 3/24/22 revealed that the patient's blood sugars had not been assessed. Further, the patient was discharged from SN services by CM #1. At the time of this review, there was no documented evidence that the Clinical Manager ensured the patient's needs, specifically blood sugars, were continually assessed. These findings were reviewed with and acknowledged by the Administrator and CM #1 during an interview on 3/16/23 at 12:26 p.m. MR #3: The patient's SOC was 3/15/23 with diagnoses that included Diabetes Mellitus, Hypertension, Urinary Retention and Bilateral Footdrop. During the record review on 3/15/23 at 10:40 a.m., the referral documents revealed the patient had a history of low blood sugar and kidney problems, was bedbound and had an indwelling urinary catheter (Foley). On 3/15/23 at 12:30 p.m., a scheduled home visit was conducted with the Registered Nurse (RN #1) and the Clinical Manager (CM #1) who was present during the visit. During the visit, the following was observed: RN #1 failed to assess the patient's respiratory rate, bowel sounds, skin, Foley catheter and its insertion site. During the visit, RN #1 used a battery-operated automated blood pressure machine to check the patient's blood pressure which reflected an elevated reading of 178/100. RN #1 removed the cuff and replaced it on the same arm and got a reading of 175/78. RN #1 failed to assess the patient's blood pressure with a manual blood pressure cuff in order to obtain an accurate reading. Additionally, RN #1 was uncertain as to what unit of measurement (inches or centimeters) was to be used when measuring the patient's identified edema of her bilateral legs. CM #1, who was close by, failed to ensure the patient's needs were continually assessed. These findings were reviewed with and acknowledged by CM #1 at the time of discovery and again on 3/15/23 at 4:33 p.m. with Adm #1 present. CM #1 responded, "I should have took [sic] over to make sure the assessment was done properly."

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure that at least one qualifying service was provided directly by agency employees, resulting in the potential for interruption in continuity of care and unmet care needs for all four patients serviced by this agency. Findings include: During the survey entrance interview conducted on 3/14/23 at 2:45 PM, it was queried what services the agency provided. The agency's Administrator (Adm.#1) acknowledged the following services: Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Speech Therapy (ST), and Master of Social Work (MSW) services. Adm.#1 was further queried what service(s) were directly hired with no affiliation with any other contracted agencies. Adm.#1 stated, "Social Work" with no other services noted and Adm.#1 also signed the CMS form 1572 on 3/14/23 attesting MSW services had no contractual agreements. However, during review on 3/16/23, 2 of 3 current contracts with other agencies were found to include the following services: SN, PT, OT, ST, MSW, and HHa (Home Health Aide). At 10:51 AM., Adm.#1 acknowledged the above findings and failed to meet the requirement of having at least one service with no contracted/1099 affiliations.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record was complete and included clinical notes for 2 (MR#'s 5, 7) records, from a total of 6 records reviewed in which skilled nursing services were provided (See G-1012); and failed to ensure that discharge and transfer summaries were completed and sent to the physician for review in 3 (MR#'s 4, 6, 7) records, from a total sample of 7 records reviewed (See G-1022). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR§484.110 Clinical Records.

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, the agency failed to ensure the clinical record contained skilled nursing clinical notes for 2 (MR#'s 5, 7) records, from a total sample of 6 records reviewed in which skilled nursing services were provided, resulting in a lack of information regarding the health status of this patient. Findings include: During entrance interview on 3/14/23 at 2:30 PM., the agency Administrator (Adm.#1) was queried when visit notes were to be completed and turned in. Adm.#1 replied, "5 days." No agency policy contained language that contradicted this response. MR#5: The patient was admitted to the home care agency on 2/11/23 with diagnoses which included diabetes-type 2, hypertension, chronic obstructive pulmonary disease, and dependance on supplemental oxygen. The Plan of Care (POC) ordered skilled nursing (SN) 1w1 followed by 2W6 (twice a week for 6 weeks). On 3/16/23, record review noted the following SN clinical notes were blank: 2/27/23, 3/2/23, and 3/6/23. On 2/16/23 and 2/20/23, the visit notes by SN failed to document what the patient's oxygen saturation level was. On 3/16/23 at 4:12 PM., the Clinical Manager (CM#1) was queried why there was no information in the medical record concerning the care, results and responses to interventions and treatments provided. CM#1 responded, "That's on me, I've been too busy to get to it." CM#1 continued to express the agency does not have enough nurses to fill the needs of the agency. MR#7: The start of care date was 12/1/22, with diagnosis that included back pain, insulin dependent diabetes, and hypertension. Record review on 3/16/23 noted the patient was transferred on 12/13/22 and admitted to the hospital for potential heart attack. A resumption of care was documented on 2/16/23. The POC ordered SN at a visit frequency of 2W8. Further record review noted the following incomplete or blank SN clinical notes after the patient was discharged from the hospital: 12/20/22-incomplete, 12/22/22-blank, 12/27/22-blank, 12/30/22-blank, 1/9/23-incomplete, and 1/24/23-blank. The patient was re-certified on 1/30/23 with an ordered SN visit frequency of 1W1, 2W8. Continued record review noted the following incomplete or blank SN clinical notes: 2/23/23-blank, 2/27/23-blank, 3/2/23-blank, and 3/7/23-blank. The above findings were reviewed with and acknowledged by the Administrator and the Clinical Manager on 3/17/23 at 11:35 AM. The agency failed to meet agency expectations significantly regarding timely submission of documentation of over 3 months, including visits after MR#7 was discharged from the hospital for heart related issues.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a discharge summary was completed which provided the patient's health status at the time of discharge, progress toward goals, and forwarded to the physician within 5 days of discharge in 2 (MR#'s 4, 6) of 3 discharged records; and failed to ensure a transfer summary was sent to the physician/receiving facility within 2 business days of the patient's transfer for 1 (MR #7) of 1 record in which the patient was transferred to an inpatient facility from a total sample of 7 records reviewed, resulting in the physician/receiving facility not having a comprehensive and current health status of the patient at the time of transfer, and the potential for unidentified health care concerns and unmet care needs. Findings include: Agency Policy: "Discharge Summary" (dated 2018) pg. 35 stated, "A Discharge Summary will be completed for all patients discharged from the Agency. The physician will be notified regarding discharge and a copy of the Discharge Summary will be sent to the physician." Agency Policy: "Transfer Criteria" (dated 2018) pg. 80 stated, "Transfer Summary will be provided to receiving organization within two (2) business days of transfer when Agency is actively involved in the transfer process." MR#4: The patient was admitted to the home care agency on 7/21/22 with diagnoses which included chronic obstructive pulmonary disease, hypotension, and back pain. On 3/16/23, record review noted the patient was discharged from the agency on 9/1/22. However, further review found no evidence of a discharge summary in the medical record. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:39 AM. MR#6: The start of care date was 7/2/22 with diagnoses which included poly-osteoarthritis, muscle weakness, hypertension, and diabetes-type 2. On 3/16/23, record review noted the patient was discharged from the agency also on 9/1/22. Additional review found no evidence of a discharge summary in the medical record. The above findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:42 AM. MR#7: The start of care date was 12/1/22, with diagnosis that included back pain, insulin dependent diabetes, and hypertension. Record review on 3/16/23 noted the patient was transferred on 12/13/22 and admitted to the hospital for potential heart attack. A resumption of care was documented on 2/16/23. Record review found no evidence that a transfer summary was ever completed and sent to the receiving hospital as stipulated by the agency's policy above. The findings were reviewed with and acknowledged by the Administrator (Adm#1) and the Clinical Manager (CM#1) during an interview on 3/17/23 at 11:44 AM.

Administrator CFR(s): 484.115(a) Standard: Administrator, home health agency. (1) For individuals that began employment with the HHA prior to January 13, 2018, a person who: (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. (2) For individuals that begin employment with an HHA on or after January 13, 2018, a person who: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; and (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. This STANDARD is not met as evidenced by: Based on interview and record review, the Agency's Governing Board failed to ensure the appointed Administrator was qualified, in accordance with this requirement, to provide oversight of the Agency's operations, resulting in the absence of qualified leadership and the potential for the rendering of unsafe patient care practices. Findings include: Job Description: Administrator, 2018 stated, "The Administrator ensures quality and safe delivery of home health care services; coordinates services that reflect the Agency's philosophy and standards of care..., Qualifications: A person who is a licensed Physician, or is a Registered Nurse, or has training and experience in health services administration and at least one (1) year of supervisory or administrative experience in home health care or related health program." On 3/16/23 at 10:00 a.m., the Administrator (Adm #1) was asked for permission to review the Governing Board's Delegation of Authority which identified who had been appointed Administrator of the Agency. Additionally, Adm #1 was asked of her qualifications as the Administrator, to which she responded, "I've been an LPN (Licensed Practical Nurse) for 6 years. I worked as a Medical Assistant (MA). I was hired as an MA by the Agency owner and worked as the Intake Coordinator. I went to RN (Registered Nurse) school, but I wasn't successful, so I did the LPN program instead. I worked at an assisted living facility as the head day nurse there. Nabeel had purchased a company (Renew Home Health) and asked all of us (several people who worked for the owner at that time) if we wanted to be a part of it, so we all put in and we each had 7% in that company. I worked as the Intake Coordinator there. The owner later called and offered me the Administrator position in 2018 because I had worked with him for so long." When asked about training or qualifications for the administrative position, Adm #1 reported, "I went through all my duties and the job description and if I didn't understand something, the Clinical Manager would help me." The Governing Board meeting minutes dated April 4, 2018, documented, "Special meeting called for the selection of an Administrator. Sonila Brahimi (Administrator/Adm #1) has been selected for this role due to her many roles and years working with Mr. Nabeel (Owner). She will begin working in this role as of April 4, 2018." Upon review of Adm #1's resume, it was noted to align with the experiences discussed during the above interview. It was determined that the Agency's Governing Board failed to ensure the appointed Administrator was qualified, in accordance with this requirement, to provide oversight of the Agency's operations.