Every finding on record at Innova, LLC

The Oklahoma State Department of Health conducted an unannounced Medicare Emergency Preparedness Program survey at the agency on 04/05/23 to 04/06/23. 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), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to ensure a community-based risk assessment (All Hazards Risk Assessment) that identified the agency and showed a subsequent date of review or update for the agency, its patient population, or its employees. Findings: A review of administrative records showed documentation of a community-based risk assessment dated 08/15/19. The assessment showed no identification of the agency and showed no subsequent date of review or update for the agency, its patient population, or its employees. On 04/06/23 at 2:15 p.m., Staff B stated the AHRA did not identify the agency and showed no date the assessment was last reviewed for the agency since 08/15/19.

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure development, implementation and maintenance of processes for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials, including contact information for the resources, for all patients and employees. Findings: A review of administrative records showed no administrative processes for an integrated emergency preparedness response with Federal, State, Tribal, Regional and Local emergency management officials for the agency were in place. On 04/06/23 at 2:15 p.m., Staff B stated the agency did not have an Emergency Preparedness Plan administrative processes for an integrated emergency preparedness response that included contact information for the Federal, State, Tribal, Regional and Local emergency management resources.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure an Emergency Preparedness Communication Plan included updated required information related to the staff and patient contact information for the agency for all patients and staff. Findings: A review of administrative records showed no documentation the Emergency Preparedness Communication Plan included staff and patient contact information for the agency. On 04/06/23 at 2:20 p.m., Staff B stated the active staff member call list and active patient list was not included in the Emergency Preparedness Communication Plan 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), §485.542(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 ensure emergency preparedness disaster table-top exercises, drills, community drills or plan activation events were conducted for calendar years 2021 and 2022 for all patients and employees. Findings: A review of administrative records related to emergency preparedness showed no documentation of emergency preparedness disaster table-top exercises, drills, community drills or plan activation events for calendar years 2021 and 2022. On 04/06/23 at 2:15 pm, Staff B stated the agency had no emergency preparedness disaster table-top exercises, drills, community drills or plan activation events for calendar years 2021 and 2022.

The Oklahoma State Department of Health conducted an unannounced Medicare re-certification survey at the agency on 04/05/23 to 04/06/23. An entrance conference was conducted with Staff C. The survey process was explained. Questions were answered. Staff A was identified as the contact person for administrative and clinical issues and Staff B was identified as an additional contact person for administrative issues. Findings were discussed during an informal exit conference with Staff A, B, C and D. Standard level deficiencies were cited as a result of the survey. Glossary: EP Emergency Preparedness HHA Home Health Agency PIP Performance Improvement Project POC Plan of Care QAPI Quality Assessment and Performance Improvement SN skilled nurse

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure advance beneficiary notice and/or HHCOC notice were provided to two (Patients #5 and #8) of 10 patients. Findings: Patient #5 A review of the POC dated 02/24/23 to 04/24/23 showed a SN visit frequency of three times a week for six weeks, effective week of 03/02/23. Documentation showed no home health change of care notice prior to discharge from skilled nursing services at the agency on 03/15/23. On 04/06/23 at 2:50 p.m., Staff A stated there was no HHCOC notices in the clinical record for patient #5 prior to being discharged from SN services at the agency. Patient #8 A review of the clinical record showed no advance notice of discharge prior to discharge from the agency on 01/30/23 for noncompliance. On 04/06/23 at 3:05 p.m., Staff A stated there was no ABN in the clinical record and patient #8 prior to being discharged from the agency for noncompliance.

Advise the patient of discharge for cause CFR(s): 484.50(d)(5)(i) (i) Advise the patient, representative (if any), the physician(s) or allowed practitioner(s), issuing orders for the home health plan of care, and the patient's 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) that a discharge for cause is being considered; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure: 1. Documentation of the problems encountered by the HHA related to behaviors that impeded the HHA from providing care and services for one (Patient #8) of 10 patients; 2. Education of the patient on potential health outcomes from discontinued HHA care and services for one (Patient #8) of 10 patients; 3. Notification of the physician of the patient's behaviors that impeded the HHA from providing care and services for one (Patient #8) of 10 patients and; 4. The physician was informed of the patient’s imminent discharge from the HHA for cause for one (Patient #8) of 10 patients. Findings: Patient #8 A review of a plan of care for 01/15/23 to 01/30/23 (03/15/23 official end of episode period) showed an SN visit frequency of two times a week for eight weeks, then one times a week for one week for SN to assess and perform wound care to wound sites. Documentation showed SN missed visits on 01/18/23, 01/21/23 and on 01/25/23 due to patient cancellation of care/visits. Documentation showed no identified problems encountered by the HHA related to behaviors or conditions that impeded the HHA from providing care and services, no communication or education attempts to the patient for potential health outcomes resulting from discontinued HHA care and services, no physician notification of the patient's behaviors and living conditions that impeded the HHA from providing care and services and no notification to the physician of the patient’s imminent discharge from the HHA for cause prior to the discharge date of 01/30/23. On 04/06/23 at 3:05 p.m., Staff A stated there was no documentation of: 1. Problems encountered by the HHA related to behaviors and conditions that impeded the HHA from providing care and services; 2. Patient education of potential health outcomes from discontinued HHA care and services; 3. Physician notification of the patient's behaviors that impeded the HHA from providing care and services prior to the discharge and; 4. Physician notification of the patient’s imminent discharge from the HHA for cause/noncompliance.

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 one (Patient #8) of 10 patients. Findings: Patient #8 A review of the clinical record showed the patient was discharged from the agency on 01/30/23 for cause/noncompliance. Documentation showed no discharge summary and no summary of care was provided to the patient and the receiving service provider. On 04/06/23 at 3:05 p.m., Staff A stated the clinical record showed no discharge summary and/or summary of care for patient #8 and did not show a discharge summary was provided to the patient or physician at the time of discharge from agency services.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure an individualized patient POC included pain reporting parameters for four (Patients #2, 3, 5 and #10) of 10 patients. Findings: Patient #2 A review of a POC dated 03/03/23 to 05/01/23, showed orders for a SN visit frequency of one time a week for eight weeks for SN to assess, instruct, monitor and report to the physician the patient’s pain level. Documentation showed no physician pain reporting parameters on the POC. Documentation showed patient reported pain levels during SN visits dated 03/08/23 reported pain level of 5; 03/13/23 reported pain level of 7; 03/15/23 reported pain level of 6; 03/22/23 reported pain level of 6; and on 04/05/23 reported pain level of 3. Documentation showed no physician notification of the patient’s reported pain levels and no change in orders. On 04/06/23 at 2:35 p.m., Staff A stated the POC for patient #2 should have included physician pain reporting parameters. Patient #3 A review of a POC dated 02/17/23 to 04/17/23, showed orders for a SN visit frequency of one time a week for eight weeks for SN to assess, instruct, monitor and report to the physician the patient’s pain level. Documentation showed no physician pain reporting parameters on the POC. Documentation showed patient reported pain levels during SN visits dated 03/31/23 reported pain level of 8. Documentation showed no physician notification of the patient’s reported pain levels and no change in orders. On 04/06/23 at 2:40 p.m., Staff A stated the POC for patient #3 should have included physician pain reporting parameters. Patient #5 A review of a POC dated 02/24/23 to 04/24/23, showed orders for a SN visit frequency of one time a week for four weeks; then effective 03/02/23 three times a for six weeks for SN to assess, instruct, monitor and report to the physician the patient’s pain level. Documentation showed no physician pain reporting parameters on the POC. Documentation showed patient reported pain levels during SN visits dated 02/24/23 reported pain level of 6; 02/28/23 reported pain level of 5; 03/01/23 reported pain level of 5; 03/04/23 reported pain level of 6; 03/08/23 reported pain level of 5; and on 03/13/23 reported pain level of 5. Documentation showed no physician notification of the patient’s reported pain levels and no change in orders. On 04/06/23 at 2:50 p.m., Staff A stated the POC for patient #5 should have included physician pain reporting parameters. Patient #10 A review of a POC dated 03/03/23 to 05/10/23, showed orders for a SN visit frequency of one time a week for eight weeks for SN to assess, instruct, monitor and report to the physician the patient’s pain level. Documentation showed no physician pain reporting parameters on the POC. Documentation showed patient reported pain levels during SN visits dated 03/08/23 reported pain level of 5; 03/13/23 reported pain level of 7; 03/15/23 reported pain level of 6; 03/22/23 reported pain level of 6; 03/29/23 reported pain level of 3; and on 04/05/23 reported pain level of 3. Documentation showed no physician notification of the patient’s reported pain levels and no change in orders. On 04/06/23 at 3:20 p.m., Staff A stated the POC for patient #5 should have included physician pain reporting parameters.

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 all patients and employees. Findings: Administrative records of ongoing patient centered QAPI program for the agency which showed data collection activities utilized in the agency's QAPI Program for calendar years 2021 and 2022 were requested. Documentation showed no meeting dates and no review and analysis of quality indicator data for the agency. On 04/06/23 at 2:15 p.m., Staff B stated: 1. Documentation showed no meeting dates for calendar years 2021 and 2022 and; 2. No program improvement data and no analysis of collected data that showed improved quality of patient care for calendar years 2021 and 2022.

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 evidence of patient centered QAPI Program activities for 3rd and 4th quarters of calendar year 2022 for all patients and employees. Findings: Administrative records of ongoing patient centered QAPI program activities for the agency for calendar years 2021 and 2022 were requested. No documentation of 3rd and 4th quarters of calendar year 2022 were provided. On 04/06/23 at 2:15 p.m., Staff B stated there was no documentation of ongoing QAPI program activities to improve the care, services, and operations of the agency for 3rd and 4th quarters of calendar year 2022.

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 calendar years 2021 and 2022 for all patients and employees. Findings: Administrative records of an ongoing patient centered QAPI program for the agency which showed conduction of a QAPI program PIP calendar years 2021 and 2022 were requested. Documentation of a PIP for calendar year 2020 showed no baseline and subsequent status of measurable goals and showed no PIP review, analysis or follow up. Documentation of a PIP for calendar years 2021 and 2022 were not provided. On 04/06/23 at 2:15 p.m., Staff B stated documentation showed no ongoing QAPI program PIPs for calendar years 2021 and 2022.

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 SN visit notes were completed for one (Patients #5) of 10 patients. Findings: Patient #5 A plan of care dated 02/24/23 to 04/24/23 documented a principal diagnosis of left hip joint replacement. Documentation showed a SN visit frequency of one times a week for four weeks; then three times a week for six weeks, effective week of 03/02/23 for SN to assess and conduct wound site care every visit. Documentation showed SN visits note on 03/01/23, 03/02/23, 03/04/23 and on 03/08/23 documented wound site assessments but documented no wound site care was performed. On 04/06/23 at 2:50 p.m., Staff A stated the SN visit notes for patient #5 showed no documented wound site care was performed by the SN staff.

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 a record review and interview, the agency failed to ensure multi-disciplined skilled professional staff were available to participate and provide input into the agency’s QAPI program for all patients and employees. Findings: Administrative records of multi-disciplined skilled professional staff participation in the agency’s QAPI program calendar years 2021 and 2022 were requested. Documentation showed no meeting dates and no multi-discipline professional staff participation for calendar year 2021 and 01/01/22 to 06/30/22. Documentation showed no QAPI program activities/meetings for 3rd and 4th quarters of calendar year 2022. On 04/06/23 at 2:15 p.m., Staff B stated there was no documentation which showed evidence of ongoing QAPI program activities that showed multi-discipline professional staff participation to improve the care, services, and operations of the agency calendar years 2021 and 2022.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body oversite of: 1. A patient centered QAPI Program for calendar years 2021 and 2022 and; 2. An operating budget, capital expenditure plan and allocation of resources activities for calendar years 2021 and 2022 for all patients and staff. Findings: Administrative records which showed governing body over-site and responsibility for the agency for calendar years 2021 and 2022 were requested. Documentation showed no governing body review of the patient centered QAPI Program activities with approval of the agency’s QAPI program plan for calendar years 2021 and 2022 and showed no operating budget, capital expenditure plan and allocation of resources activities for calendar years 2021 and 2022. On 04/06/23 at 2:30 p.m., Staff B stated: documentation showed no ongoing governing body review of the patient centered QAPI Program activities with approval of the agency’s QAPI program plan for calendar years 2021 and 2022 and showed no operating budget, capital expenditure plan and allocation of resources activities for calendar years 2021 and 2022.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure governing body appointment of the alternate clinical manager and/or alternate supervising RN for the agency effecting all patients and staff. Findings: Administrative records of governing body over-site of the agency for calendar years 2021 and 2022 was requested; including appointment of the alternate clinical manager and/or alternate supervising RN for the agency. No documentation was provided. On 04/06/23 at 2:00 p.m., Staff B stated the agency had not appointed an alternate clinical manager/supervising RN for the agency.