Every finding on record at Heart Care at Home, LLC

The Oklahoma State Department of Health conducted an unannounced Medicare Emergency Preparedness Program survey at the agency on 06/14/22 to 06/15/22. Standard deficiencies were cited as a result of the Emergency Preparedness Program survey.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record reivew and interview, the agency failed to ensure a community-based risk assessment (All Hazards Risk Assessment) for 29 patients and all employees. Findings: A review of administrative records showed a community-based risk assessment which was undated and did not identify the agency, its patient population, or its employees. On 06/15/22 at 2:30 p.m., Staff A stated the agency had no emergency preparedness community-based risk assessment that was dated and identified the agency, its patient population, or its employees.

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), §485.625(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 ensure its Emergency Preparedness Program, including its written policies and procedures were reviewed annually for 29 patients and all employees. Findings: A review of administrative records showed no Emergency Preparedness Program reviewed annually in calendar years 2020, 2021 and 01/01/22 through 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated the agency had no documentation its Emergency Preparedness Program was reviewed annually in calendar years 2020, 2021 and 01/01/22 through 06/15/22.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure documentation of an Emergency Preparedness Communication Plan which included required information related to the agency staff contact information for 29 patients and all employees. Findings: A review of administrative records showed no documentation the Emergency Preparedness Communication Plan included staff contact information for the agency. On 06/15/22 at 2:30 p.m., Staff A stated the active staff member call list was not included in the Emergency Preparedness Communication Plan for the agency.

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), §485.625(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 ensure documentation of an Emergency Preparedness Communication Plan which included required contact information for the emergency management resource agencies for the agency effecting 29 patients and all employees. Findings: A review of administrative records showed no documentation the Emergency Preparedness Communication Plan included contact information for the emergency management resource agencies for the agency. On 06/15/22 at 2:30 p.m., Staff A stated the Emergency Preparedness Communication Plan did not include required contact information for the emergency management resource agencies for the agency.

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), §485.625(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, 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 ensure documentation of an emergency preparedness testing and training education program for 29 patients and all employees. Findings: A review of administrative records showed no Emergency Preparedness testing and training education program for the agency. On 06/15/22 at 2:30 p.m., Staff A stated the Emergency Preparedness Plan did not show documentation of an Emergency Preparedness testing and training education program for the agency.

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), §485.625(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, 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 ensure an emergency preparedness disaster table-top exercise and/or drill was conducted by the agency for 29 patients and all employees. Findings: A review of administrative records related to emergency preparedness showed no agency disaster table-top exercise, drill or participation in a community-based drill or declaration for calendar years 2020, 2021 or 01/01/22 through 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated the agency had no documentation of an emergency preparedness disaster table-top exercise, drill or participation in a community-based drill or declaration for calendar year 2020, 2021 or 01/01/22 through 06/15/22.

The Oklahoma State Department of Health conducted an unannounced Medicare re-certification survey at the agency on 06/14/22 through 06/15/22. An entrance conference was conducted with Staff A. The survey process was explained. Questions were answered. Staff A and Staff B were identified as the contact persons for administrative and clinical issues. Findings were discussed during an informal exit conference with Staff A and B. Condition level deficiencies were cited in the following areas: 484.60 Care Planning, Coordination of Care 484.65 Quality Assessment Performance Improvement 484.70 Infection Prevention and Control Glossary: HIPPA Health Information Privacy Protection Act OSDH Oklahoma State Department of Health PIP Performance Improvement Project POC Plan of Care RN Registered Nurse SN Skilled Nurse SNF Skilled Nurse Facility

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a medication profile was reviewed and updated with a medication regimen change for one (Patient #3) of seven patients. Findings: Patient #5 A review of a POC dated 05/26/22 to 07/24/22 showed a medication, Sensipar 30 milligrams every day. A review of a SN visit note dated 05/31/22 showed the medication was discontinued. A review of clinical documentation showed no change in the medication profile, no follow up communication with the physician and no change in orders. On 06/15/22 at 2:00 p.m., Staff B stated the medication profile should have been updated to reflect the medication had been discontinued by the physician.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure completion of a transfer/discharge summary for three (Patients #4, 6 and #7) of seven patients. Findings: Patient #4 A review of the clinical record showed documentation of transfer from the agency on 06/06/22 to in-patient provider services. Documentation showed the transfer summary was incomplete and showed no summary of care and services provided by the agency. Patient #6 A review of the clinical record documented discharge from the agency on 06/09/22 to in-patient provider services. Documentation showed the discharge summary was incomplete and showed no summary of care and services provided by the agency. Patient #7 A review of the clinical record documented discharge from the agency on 05/19/22 to in-patient SNF provider services. Documentation showed the discharge summary was incomplete and showed no summary of care and services provided by the agency. On 06/15/22 at 2:00 p.m., Staff B stated the agency did not complete the transfer/discharge summaries with required documentation of care and services provided by the agency for Patients #4, 6 and #7.

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 record review and interview, the agency failed to ensure the individualized patient POCs included: 1. Pain reporting parameters for five (Patients #1, 3, 4, 5 and #7) of seven; 2. Recurring urinary catheter change treatment due dates for one (Patient #1) of seven; 3. Wound care treatment interventions and related goals for two (Patients #2 and #7) of seven; 4. SN visit frequency for one (Patient #2) of seven; 5. PT visit frequency for one (Patient #2) of seven; 6. Recurring subcutaneous injection treatment due dates for two (Patient #5 and #7) of seven patients. This failed practice had the potential to effect the well-being and health outcomes for all patients. See Tag G574. Based on record review and interview, the agency failed to ensure physician orders were documented for: 1. Occupational therapy visit frequencies for two (Patients #1 and #5) of seven; 2. Medication regimen change for one (Patient #3) of seven and; 3. Physical therapy visit frequency for one (Patient #6) of seven patients. This failed practiced placed patients at risk of receiving inappropriate care and services which had the potential to effect the health outcomes for all patients. See Tag G576. Based on record review and interview, the agency failed to ensure SN performed wound care as ordered by the physician for one (Patient #7) of seven patients. This failed practice had the potential to effect the wound site outcomes for all patients with wound site care. See Tag G580. Based on record review and interview, the agency failed to ensure physician notification of changes in health conditions for one (Patient #7) of seven patients. This failed practice had the potential to effect the health and wellness outcomes for all patients. See Tag G590.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the individualized patient POCs included: Pain reporting parameters for five (Patients #1, 3, 4, 5 and #7) of seven;Recurring urinary catheter change treatment due dates for one (Patient #1) of seven;Wound care treatment interventions and related goals for two (Patients #2 and #7) of seven;SN visit frequency for one (Patient #2) of seven;PT visit frequency for one (Patient #2) of seven; Recurring subcutaneous injection treatment due dates for two (Patient #5 and #7) of seven patients. This failed practice had the potential to effect the well-being and health outcomes for all patients. Findings: Patient #1 A review of the plan of care dated 05/30/22 to 07/28/22 documented a principal diagnosis of stage II pressure ulcer. Documentation showed: 1. SN to assess and teach pain management with a patient goal of pain within comfort limit. Documentation showed no identification of pain level associated with patient comfort limit and no pain reporting parameter for physician notification of the patient’s pain level outside of comfort limit and; 2. SN to change indwelling Foley catheter every month. Documentation showed no treatment date the indwelling Foley catheter change was due. Patient #2 A review of the plan of care dated 05/27/22 to 07/25/22 documented a principal diagnosis of stage II pressure ulcer. Documentation showed no: 1. SN visit frequency; 2. PT visit frequency and; 3. Wound site assessment, care/interventions or goals. Patient #3 A review of the plan of care dated 05/26/22 to 07/24/22 documented a principal diagnosis of Diabetes Mellitus Type II. Documentation showed SN to assess and teach pain management with a patient goal of pain within comfort limit. Documentation showed no identification of pain level associated with patient comfort limit and no pain reporting parameter for physician notification of the patient’s pain level outside of comfort limit. Patient #4 A review of the plan of care dated 05/17/22 to 0/15/22 documented a principal diagnosis of Diabetes Mellitus Type II. Documentation showed SN to assess and teach pain management with a patient goal of pain within comfort limit. Documentation showed no identification of pain level associated with patient comfort limit and no pain reporting parameter for physician notification of the patient’s pain level outside of comfort limit. Patient #5 A review of the plan of care dated 05/29/22 to 07/27/22 documented a principal diagnosis of congestive heart failure. Documentation showed: 1. SN to assess and teach pain management with a patient goal of pain within comfort limit. Documentation showed no identification of pain level associated with patient comfort limit and no pain reporting parameter for physician notification of the patient’s pain level outside of comfort limit and; 2. SN to perform subcutaneous injection monthly. Documentation showed no treatment date the subcutaneous injections were due. Patient #7 A review of the plan of care dated 05/02/22 to 07/01/22 documented a principal diagnosis of Diabetes Mellitus Type II. Documentation showed: 1. SN to assess and teach pain management with a patient goal of pain within comfort limit. Documentation showed no identification of pain level associated with patient comfort limit and no pain reporting parameter for physician notification of the patient’s pain level outside of comfort limit; 2. SN to perform subcutaneous injection monthly. Documentation showed no treatment date the subcutaneous injections were due and; 3. SN to teach and initiate wound order set. Documentation showed no wound site assessment, care / interventions or goals. On 06/15/22 at 2:00 p.m., Staff B stated individualized POCs should have documented but was not for the following: 1. Pain reporting parameters for Patients #1, 3, 4, 5 and #7; 2. Recurring urinary catheter change treatment due dates for Patient #1; 3. Wound care treatment interventions and related goals for Patients #1, 2 and #7; 4. SN visit frequency for Patient #2; 5. PT visit frequency for Patient #2 and; 6. Recurring subcutaneous injection treatment due dates for Patient #5 and #7.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure physician orders were documented for: Occupational therapy visit frequencies for two (Patients #1 and #5) of seven;Medication regimen change for one (Patient #3) of seven and; Physical therapy visit frequency for one (Patient #6) of seven patients. This failed practiced placed patients at risk of receiving inappropriate care and services which had the potential to effect the health outcomes for all patients. Findings: Patient #1 A review of an occupational therapy evaluation dated 05/30/22 showed a recommended OT visit frequency of two times a week for five weeks. Documentation showed no physician notification of the OT evaluation or physician orders (the OT evaluation was not sent to the physician for notification and signature, 16 days after the evaluation). A review of the clinical record showed OT visits were conducted on 05/31/22, 06/03/22, 05/03/22, 06/07/22 and on 06/09/22 (five visits conducted, no visits ordered.) Patient #3 A review of a SN visit note dated 05/31/22 showed the medication, Sensipar was discontinued. Documentation showed no change in the medication profile, no follow up communication with the physician and no change in orders. Patient #5 A review of an occupational therapy evaluation dated 05/28/22 showed a recommended OT visit frequency of two times a week for five weeks. Documentation showed no physician notification of the OT evaluation or physician orders (the OT evaluation was not sent to the physician for notification and signature18 days after the evaluation). A review of the clinical record showed OT visits were conducted on 05/31/22, 06/03/22, 05/03/22, 06/07/22 and on 06/09/22 (five visits conducted, no visits ordered.) Patient #6 A review of a physical therapy evaluation dated 04/18/22 showed a recommended PT visit frequency of two times a week for four weeks. Documentation showed no physician notification of the PT evaluation or physician orders (the PT evaluation was not sent to the physician for notification and signature 46 days after the evaluation). A review of the clinical record showed PT visits were conducted on 04/20/22, 04/25/22, 04/27/22, 05/02/22, 05/05/22, 05/09/22, 05/10/22, and on 06/07/22 (eight visits conducted, no visits ordered.) On 06/15/22 at 2:00 p.m., Staff B stated: OT should have documented a verbal order from the physician or sent the evaluation for physician approval and signature for the OT visit frequencies on Patients #1 and #5;SN should have documented the physician order for the medication regimen change on Patient #3 and;PT should have documented a verbal order from the physician or sent the evaluation for physician approval and signature for the PT visit frequencies on Patient #6.

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 reviews and interview, the agency failed to ensure SN performed wound care as ordered by the physician for one (Patient #7) of seven patients. This failed practice had the potential to effect the wound site outcomes for all patients with wound site care. Findings: Patient #7 A review of the plan of care dated 05/03/22 to 07/01/22 showed a SN visit frequency of one time a week for nine weeks to assess and perform wound care to pressure ulcer of the left buttock. A SN visit dated 05/18/22 documented the wound site extended to the right gluteus and a new wound site to the right ischium was identified. Documentation showed wound care was performed as followed: wound sites were cleansed; wound prep was applied, and an alginate material covered with dry dressing materials was applied (wound site care and materials used were not ordered by the physician). Documentation showed no physician notification of change in wound status, use of the dressing materials and no change in orders. On 06/15/22 at 2:00 p.m., Staff B stated wound site care performed and dressing materials used for Patient #7 should have been ordered by the physician but were not.

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 record review and interview, the agency failed to ensure physician notification of changes in health conditions for one (Patient #7) of seven patients. This failed practice had the potential to effect the health and wellness outcomes for all patients. Findings: Patient #7 A review of the plan of care dated 05/03/22 to 07/01/22 showed a SN visit frequency of one time a week for nine weeks to assess and perform wound care to pressure ulcer of the left buttock. A SN visit dated 05/18/22 documented the wound site of the left buttock extended to the right gluteus and a new wound site to the right ischium was identified. Documentation showed no physician notification of wound status change, new wound sites identified and no change in orders. On 06/15/22 at 2:00 p.m., Staff B stated the Physician should have been notified of the change in wound status for Patient #7.

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, the agency failed to ensure an ongoing patient centered QAPI Program for 29 patients and all employees. This failed practice had the potential to place all patients and employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. See Tag G642. Based on record review and interview, the agency failed to ensure utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement for 29 patients and all employees. This failed practice had the potential to place all patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. See Tag G644. Based on record review and interview, the agency failed to ensure conduction of patient centered QAPI Program activities for 29 patients and all employees. The failed practice had the potential to place all patients and employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. See Tag G646. Based on record review and interview, the agency failed to ensure the initiation and review of a PIP through their QAPI Program for 29 patients and all employees. This failed practice had the potential to place the agency, all patients and employees at risk for stagnated efforts for improvement as a result of unidentified problematic clinical, administrative, infection control or personnel problems. See Tag G658. Based on record review and interview, the agency failed to ensure governing body oversite of the conduction of patient centered QAPI Program activities for all patients and employees. This failed practice had the potential to place all patients and employees at risk for insufficient governing body oversite of agency services and operations. See Tag G660.

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, the agency failed to ensure evidence of an ongoing patient centered QAPI Program for 29 patients and all employees. This failed practice had the potential to place all patients and employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. Findings: A review of administrative records showed no ongoing patient centered QAPI program and no multi-source QAPI data collected, monitored or evaluated by the agency. Documentation showed documents titled, QAPI meeting, dated 04/20/20, 07/06/20, 10/06/20, 03/08/21, 06/07/21, 09/06/21 and 12/06/21. Documentation showed limited data without attendant identification or authentication and no meeting documentation for 01/01/22 through 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated: The agency did not meet quarterly as QAPI during calendar years 2020, 2021 and no meeting or reporting has taken place for 01/01/22 through 06/15/22;Reported QAPI data/documentation was collected from case conference staff meetings to identify problems and; Documentation showed no measurable improvement and no measurements, analysis, tracking or evaluation of data by the agency.

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, the agency failed to ensure utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement for 29 patients and all employees. This failed practice had the potential to place all patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. Findings: A review of administrative records showed no data collection activities utilized in the agency's QAPI Program for calendar years 2020, 2021 and 01/01/22 through 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated: 1. They had no analysis of data collected available that showed improved quality of patient care for calendar years 2020 and 2021 and; 2. Program improvement data was not available for review for 01/01/22 through 06/15/22.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure conduction of patient centered QAPI Program activities for 29 patients and all employees. The failed practice had the potential to place all patients and employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. Findings: A review of administrative records showed no ongoing QAPI program activities to improve the care, services, and operations of the agency for calendar years 2020 and 2021 and 01/01/22 through 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated they had no QAPI documentation which showed QAPI program activities for calendar years 2020 and 2021 and 01/01/22 through 06/15/22.

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, the agency failed to ensure the initiation and review of a PIP through their QAPI Program for 29 patients and all employees. This failed practice had the potential to place the agency, all patients and employees at risk for stagnated efforts for improvement as a result of unidentified problematic clinical, administrative, infection control or personnel problems. Findings: A review of QAPI records showed no initiation, review, data analysis, or status of PIPs in calendar year's 2020, 2021 and 01/01/22 through 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated the agency had no documentation which showed PIP activities in calendar year's 2020, 2021 and 01/01/22 through 06/15/22.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of the conduction of patient centered QAPI Program activities for all patients and employees. This failed practice had the potential to place all patients and employees at risk for insufficient governing body oversite of agency services and operations. Findings: A review of administrative records showed no governing body oversite of ongoing QAPI program activities to improve the care, services, and operations of the agency for calendar years 2020, 2021, and 01/01/22 through 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated they had no documentation which showed governing body oversite of QAPI program activities for calendar years 2020, 2021, and 01/01/22 through 06/15/22.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to ensure infection control policies and procedures followed accepted standards of practice to prevent infection and disease for 29 patients and all employees. This failed practice placed the agency at risk for substandard infection control practices throughout the agency for all patients and employees. See Tag 682. Based on record review and interview, the agency failed to ensure: 1. The infection control program included comprehensive infection control surveillance activities and interventions to reduce future infections and promote learning and preventative measures throughout the agency and; 2. The infection control program was included in QAPI activities for 29 patients and all employees. This failed practice placed the agency at risk for missed opportunities to identify and reduce the incidence and occurrence of infection throughout the agency and effect the health and well-being of all patients and employees. See Tag G684. Based on record review and interview, the agency failed to ensure the infection control education was: 1. Included in QAPI activities; 2. Showed interventions to reduce future infections; and 3. Provided and/or maintained for 29 patients and all employees. This failed practiced placed the agency at risk for missed opportunities to identify and correct substandard practices and reduced opportunities to create learning throughout the agency for all patients and employees. See Tag G686.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure infection control policies and procedures followed accepted standards of practice to prevent infection and disease for 29 patients and all employees. This failed practice placed the agency at risk for substandard infection control practices throughout the agency for all patients and employees. Findings: A review of administrative records showed no ongoing infection control program for the agency or infection control surveillance data for calendar years 2020, 2021 and 01/01/22 to 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated: 1. The agency had no comprehensive infection surveillance program in place and; 2. No infection surveillance activities were reported through the agency's QAPI program for calendar years 2020, 2021 and 01/01/22 to 06/15/22.

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 ensure: 1. The infection control program included comprehensive infection control surveillance activities and interventions to reduce future infections and promote learning and preventative measures throughout the agency and; 2. The infection control program was included in QAPI activities for 29 patients and all employees. This failed practice placed the agency at risk for missed opportunities to identify and reduce the incidence and occurrence of infection throughout the agency and effect the health and well-being of all patients and employees. Findings: A review of QAPI records showed no infection control surveillance data for calendar years 2020, 2021 and 01/01/22 to 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated: Infection surveillance activities were not conducted agency wide and; Infection surveillance activities were not reported through the agency's QAPI program.

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, the agency failed to ensure the infection control education was: 1. Included in QAPI activities; 2. Showed interventions to reduce future infections; and 3. Provided and/or maintained for 29 patients and all employees. This failed practiced placed the agency at risk for missed opportunities to identify and correct substandard practices and reduced opportunities to create learning throughout the agency for all patients and employees. Findings: A review of administrative records showed no infection control program education or learning activities provided by the agency for calendar years 2020, 2021 and 01/01/22 to 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated there was no documentation of infection control program education or learning activities provided by the agency for calendar years 2020, 2021 and 01/01/22 to 06/15/22.

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 ensure its employees either received required COVID 19 vaccination or were granted an appropriate waiver status exemption for one (Staff D) of six employees. Findings: A review of administrative records showed documentation that one of six employees did not receive required COVID 19 vaccination or were granted an appropriate waiver status exemption (83.4% participation rate of required 100% participation). On 06/15/22 at 2:30 p.m., Staff A stated the agency had no documentation which showed vaccination or exemption status for Staff D.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided as ordered on the POC for: 1. SN to conduct wound site assessment every visit for one (Patient #1) of seven; 2. SN to conduct pain assessment every visit for two (Patient #3 and #5) of seven; 3. SN visit frequencies for three (Patient #3, 4 and #5) of seven and; 4. SN to report patient weight gain greater than 5 pounds in a week to the physician for one (Patient #5) of seven patients. Findings: Patient #1 A review of the POC dated 05/30/22 to 07/28/22 showed orders for SN to conduct wound site assessment every visit. Documentation showed no wound site assessment conducted during SN visits on 06/01/22 and on 06/07/22. Documentation showed no patient/caregiver refusal of patient wound site assessment, no physician notification of changes in wound site assessment and no change in orders. Patient #3 A review of the POC dated 05/26/22 to 07/28/22 showed orders for SN assessment of pain every visit. Documentation showed a telehealth nursing visit was conducted on 06/07/22 (in-lieu of a skilled nursing visit as ordered, one missed SN visit). Documentation showed no pain assessment was conducted during the SN contact with the patient on 06/07/22. Documentation showed no patient/caregiver refusal of SN visit or pain assessment during the telehealth SN contact, no physician notification and no change in orders. Patient #4 A review of the POC dated 05/17/22 to 07/15/22 showed a SN visit frequency of one time a week for nine weeks and SN to conduct skilled nursing assessment every visit. Documentation showed a telehealth nursing visit was conducted on 05/25/22 (in-lieu of a skilled nursing visit as ordered, one missed SN visit). Documentation showed no patient/caregiver refusal of SN visit during the telehealth SN contact, no physician notification and no change in orders. Patient #5 A review of the POC dated 05/29/22 to 07/27/22 showed s SN visit frequency of one time a week for nine weeks to conduct skilled nursing assessment, to include assessment of pain and patient weight every visit and notify the physician of patient weight gain of 5 pounds in a week. Documentation showed a telehealth nursing visit was conducted on 06/01/22 (in-lieu of a skilled nursing visit as ordered, one missed SN visit). Documentation showed no physician notification of patient report of severe pain 6/10 and patient reported weight of 179.7 pounds (weight gain of 8.1 pounds since date of last SN visit on 05/25/22 of 171.8 pounds). Documentation showed no patient/caregiver refusal of SN visit, no physician notification and no change in orders. On 06/15/22 at 2:00 p.m., Staff B stated: 1. SN should have conducted a wound site assessments on Patient #1 during SN visits on 06/01/22 and 06/07/22; 2. SN should have to conducted pain assessments every visit for Patient #3 and #5; 3. SN visit frequencies should have been conducted for Patients #3, 4 and #5 as ordered by the physician’s and; 4. SN should have reported patient reported weight gain greater than 5 pounds in a week and severe pain 6/10 to the physician for Patient #5.

Participate in the HHA's QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA's QAPI program; and This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure documented participation of multi-discipline skilled professional staff in patient centered QAPI Program activities for 29 patients and all employees. Findings: A review of administrative records showed no ongoing multi-discipline QAPI program activities to improve the care, services, and operations of the agency for calendar years 2020 and 2021 and 01/01/22 through 06/15/22. On 06/15/22 at 2:30 p.m., Staff A stated they had no QAPI documentation which showed multi-discipline QAPI program activities for calendar years 2020 and 2021 and 01/01/22 through 06/15/22.

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 reviews and interview, the agency failed to ensure a completed transfer/discharge summary was provided for three (Patients #4, 6 and #7) of seven patients. Findings: Patient #4 A review of the clinical record documented transfer from the agency on 06/06/22 to in-patient provider services. Documentation showed no transfer summary was provided to the in-patient service provider. Patient #6 A review of the clinical record documented discharge from the agency on 06/09/22 to in-patient provider services. Documentation showed no discharge summary was provided to the in-patient service provider. Patient #7 A review of the clinical record documented discharge from the agency on 05/19/22 to in-patient SNF provider services. Documentation showed no discharge summary was provided to the in-patient SNF service provider. On 06/14/22 at 2:00 p.m., Staff B stated: no transfer summary was sent to the receiving in-patient service provider for Patient #4 and;No discharge summary was sent to the receiving in-patient service provider for Patients #6 and the receiving in-patient SNF service provider for Patient #7.