Every finding on record at Home Healthcare Dynamics LLC

Emergency Preparedness Survey The following deficiencies are based on the emergency preparedness survey completed 10/14/22.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on a review of the Emergency Preparedness Plan, policy review, and staff interview, the agency failed to have a list of acuity of patients in case there is an interruption of services. This has the potential to affect all patients cared for by this agency. A review of the facilities Emergency Operation Plan (EOP) tabletop exercises was conducted on 10/12/22. Tabletop exercises were completed and dated 02/20 for a snow storm, 01/21 for an electrical outage, and 04/22 for a bomb threat. Each of these exercises lists the Director of Nursing (DON) declared the emergency and implemented the plan. No documentation was found in this documentation of patient acuity listings or tracking to identify and locate high risk patients. Review of the agency policy titled "Testing Program for Emergency Operations Plan," dated 02/22, lists the exercises must sufficiently stress the Agency's plan to identify weakness. Exercises must activate and test- patient acuity assignment and tracking procedures to validate the ability to identify and locate high risk patients. Review of the agency policy titled "Home Care Priority Classification" list at Priority One: if service is not delivered as authorized, the client's health and welfare would be at immediate risk (eg. wheelchair bound and lives alone). Priority Two: if services are not delivered as ordered the clients would be at risk (eg. wheelchair bound and inconsistent or unstable support system). Priority Three: if services could not be delivered the clients health and welfare could be at risk (eg. can partially meet own needs) Interview with Staff A on 10/14/22 at 3:00 PM verified the findings of not having acuity tracking available or in the EOP binder.

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 a review of the agency Emergency Preparedness Plan, review of table top exercises, and staff interview, the agency failed to have more then one staff member involved with the table top exercises. This has the potential to affect all patients cared for by this agency. A review of the facility's Emergency Operation Plan (EOP) tabletop exercises was completed on 10/12/22. Tabletop exercises were completed on 02/20 for a snow storm, 01/21 for an electrical outage, and 04/22 for a bomb threat. Each of these exercises lists the Director of Nursing (DON) declared the emergency and implemented the plan with no evidence of other staff involvement. Review of the agency policy titled "Testing Program for Emergency Operations Plan," lists tabletop exercises include a group discussion led by a facilitator using a narrated, clinically-relevant emergency scenario, and a set of problem statements designed to challenge the EOP. It involves key personnel discussing simulated scenarios in an informal setting which can be used to assess plans, policies and procedures. Interview with Staff A on 10/12/22 revealed staff were not involved with the tabletop exercises but their yearly training was related to what tabletop exercise were to be completed for the year. The findings of not having key personnel involved with the testing for EOP tabletop exercises was verified with Staff A on 10/13/22 at 3:00 PM.

Extended Recertification Survey An entrance conference was conducted with the Director of Nursing at 11:10 AM on 10/11/22 and an exit conference was completed at 5:20 PM on 10/14/22. The following deficiencies are based on the extended recertification survey completed on 10/14/22. Home HealthCare Dynamics LLC, 369108, is not in compliance with the requirements found at 42 CFR Part 484 Subpart B, C for Home Health Agencies. Home HealthCare Dynamics is precluded from offering its own aide training and/or competency evaluation program for a period of two years from the receipt of the deficiency report (2567) for this survey.

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on a record review, review of OASIS transmissions, and staff interview, the facility failed to transmit OASIS data within 30 days of completing an assessment for seven (#1, #2, #3, #4, #5, #6, and #7) of seven patients reviewed with the potential to affect all patients cared for by this agency. Interview with Staff A stated during the entrance conference revealed the registered nurses (RNs) gather the OASIS data and Staff C transmits this information from the office with Staff A being the back-up person. Staff A further stated Staff C quit working for the agency in September. Review of the record for Patient #1 revealed recertification OASIS assessments were sent in on 05/12/22 for the dates of 02/11/22 and 04/11/22. Each of these listed the 3330 warning for submission 30 days after the M0090 completion. Patient #1 was recertified on 06/09/22 and 08/11/22 with no documentation of OASIS submissions. Review of the record for Patient #2 revealed an admit date of 03/17/18. There was no evidence of any OASIS assessments being transmitted in 2022. Review of the record for Patient #3 revealed an admit date of 09/01/21. Recertification assessments were completed on 06/23/22 and 08/24/22 with no evidence of the OASIS being submitted. Review of the record for Patient #4 revealed an OASIS assessment with the M0090 date of 01/20/22 which was submitted on 05/12/22. There was a 330 warning for the submission being 30 days past the M0090 date. Patient # 4 had recertifications on 07/19/22 and 09/16/22 with no OASIS submission completed. Review of the record for Patient #5 revealed an admission on 06/28/22. The admission OASIS was completed on 06/28/22 and the recertification OASIS was completed on 08/24/22 with no evidence they were submitted. Review of the record for Patent #6 revealed and admitssion on 06/02/22. There was no evidence the admission OASIS was submitted. Review of the record for Patient #7 revealed an admission on 03/16/22. A recertification OASIS assessment was completed on 07/01/22 and a discharge OASIS assessment was completed on 08/28/22. There was no evidence these were submitted. Interview with Staff A on 10/14/22 at 2:00 PM revealed the agency was not aware the OASIS information was not sent in. The findings of not completing the electronic transmission of OASIS information as required by CMS was verified with Staff A 10/14/22 2:35 pm.

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 medical record review and staff interview, the facility failed to complete skilled nurse visits as ordered in the plan of care. This affected two (Patient #1 and Patient #3) of seven patients reviewed with the potential to affect all patients cared for by this agency. The facility census was 37. 1. The medical record for Patient #1 was reviewed on 10/12/22. Patient #1 had a start of care )SOC) for 03/07/18 with a primary diagnosis of epilepsy. The certification period reviewed was for 08/13/22-10/11/22. The plan of care (POC) listed for skilled nurse (SN) visits two times per day Monday thru Friday and once a day on Saturday and Sunday. The SN was to complete a head to toe assessment, assess for skin breakdown, and medication set up and administration as needed. Review of the record revealed after 09/03/22 the weekend visits were completed twice per day instead of the ordered one time per day. SN visits were completed one time per day instead of the ordered two times on 09/19/22, 10/05/22, and 10/10/22. There was no evidence of the physician being notified the SN visits were not completed as ordered. Interview with Staff A on 10/14/22 at 2:35 PM verified no missed visits notes were found regarding the three above dates as well as no physician notification of the SN visits not occurring per the plan. 2. The medical record for Patient #3 was reviewed on 10/13/22. Patient # 3 had a SOC date of 09/01/21 with a diagnosis of an acute myocardial infarction. The certification period reviewed was for 08/27/22-10/25/22 with SN visits ordered one time per week to assess medication compliance, medication education and pain. No SN visit was completed for the week of 08/28/22 –09/03/22. Interview with Staff A on 10/14/22 at 2:30 PM verified no missed notes or physician notification were found for the week of 8/28/22. Interview on 10/14/22 at 2:30 PM Staff A verified SN visits were not completed as ordered in the plan of care for Patient #1 and #3.

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: This Condition is not met as evidenced by: Based on a review QSO memo 22-09-ALL Attachment G, staff interview, the staff vaccination status, and policy review, it was determined the agency failed to implement policies to make sure all staff were vaccinated against Covid-19 or had been granted a medical or religious exemption. This has the potential to affect all patients cared for by this agency. (G687). This has the potential to affect all patients cared for by this agency. The facility census is 37.

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 a review of the staff vaccination status, QSO memo 22-09-ALL Attachment G, staff interview, and review of policy, the agency failed to implement policies to make sure all staff were vaccinated against Covid-19 or had been granted a medical or religious exemption. This has the potential to affect all patients cared for by this agency. The current facility census was 37. Review of QSO memo 22-09-ALL Attachment G, dated 01/14/22, revealed within 30 days following the issuance of this memorandum policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient contact are vaccinated for COVID-19. Within 90 days and thereafter following issuance of the memorandum the agency must maintain compliance with the 100% standard for staff to have received the COVID-19 vaccination, or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the Centers for Disease Control and Prevention (CDC). Review of the agency Covid-19 staff vaccination status revealed a total of 29 staff with 19 staff members vaccinated for Covid-19 and no evidence the remaining 10 staff members had been granted a medical or religious exception. The percentage of vaccinated staff was 65.5 %. Interview with Staff B on 10/12/22 at 2:00 PM revealed the agency believed the vaccine was optional and did not require anyone to ask for an exemption. Staff B provided emails that went out to agency staff on 04/09/20 to follow the Center for Disease Control & Prevention (CDC) guidelines related to Covid-19, on 08/06/20 related to wearing masks if coming into the office, on 01/18/21 for information on where to sign up for the vaccine, and on 08/25/22 related to Covid-19 protocol and symptoms. Interview on 10/12/22 at 2:30 PM, Staff A stated they were not aware of the requirement for all the staff to be vaccinated. Staff A further indicated they just received a large infection control policy which included Covid-19 policies, but staff have not been educated on this as of yet. Review of the facility policy titled “Covid-19 Vaccine Mandate Policy,” dated February 2022, revealed at Bullet #1 the agency has developed and implemented policies and procedures to ensure that all staff are fully vaccinated for Covid-19. Bullet #5 revealed the agency will ensure that all required staff have received the applicable vaccine prior to providing care, treatment or services for the agency and/or its patients. Bullet #20 revealed all new employees are required to comply with the vaccination requirements outlined in this policy as a condition of employment. Bullet #22 revealed Employees may request an exception from this mandatory vaccination policy, if the vaccine is medically contraindicated for them or medical necessity requires a delay in vaccination. Bullet #25 revealed requests for non-medical exemptions must be approved by Agency and documented in employee health. A spiritual exemption includes documentation of the agency’s defined criteria of the employee’s sincerely held religious belief, practice or observance according to federal law and regulation. Interview with Staff A and Staff B on 10/13/22 at 2:00 PM verified the findings of not implementing a policy related to ensuring all staff are fully vaccinated or have applied or been granted an exemption to this rule.

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 medical record review, policy review, and staff interview, the facility failed to clarify the dressing solution and failed to document wound assessments according to policy. This affected one (Patient #6) of seven patients reviewed with the potential to affect all patients receiving dressing changes. Review of the medical record for Patient #6 was completed on 10/14/22. Patient #6 had a start of care (SOC) of 06/02/22 with a diagnosis of abscess to the breast and nipple. The certification period reviewed was for 06/02/22-07/31/22. The plan of care (POC) listed orders to complete dressing changes moist to dry to the right breast daily by the skilled nurse (SN). Daily dressing changes were completed with measurements completed and documented weekly. No documentation was found regarding the type of solution used for the dressing change and no documentation was found of the wound being cleansed or an assessment of the wound color, odor or if drainage was present. Interviewed with Staff A on 10/14/22 revealed the hospital discharge record stated to wash with soap and water, moist to dry dressing changes to the right medial breast wound, and cover with ABD pad and binder or a surgical bra for support. Review of the facility policy titled "Application of Wet-To Dry Dressing" revealed use prescribed solution-sterile normal saline or sterile water. Cleanse wound with prescribed solution and gauze then document in the clinical records: appearance, odor, characteristics of drainage, client’s tolerance to procedure, and time of dressing change. Interview with Staff A on 10/14/22 at 2:00 PM verified no documentation was found in the medical record for physician clarification regarding the type of solution to be used for the wet-dry dressing changes and the plan of care did not list to wash the wound. Staff A verified the facility policy titled Application of wet to dry dressings was not followed in regards to documenting wound appearance, odor, characteristics of drainage, client’s tolerance to procedure and time of dressing change.

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 staff interview and review of the agency's organizational chart, the agency failed to ensure the governing body met to assumed the full legal authority and responsibility for the agency's overall management and operation. This has the potential to affect all patients cared for by this facility. The agency census was 37. Review of the organizational chart listed two owners, a physician as the Chairman, a physician as secretary or Community Rep, and Staff A as a member of the governing body with all seats not filled. The agency provided no documentation the governing body was meeting to review the management and operations of the agency. Interview on 10/14/22 at 5:00 PM, Staff A verified the findings of not having meeting minutes to designate the responsible oversight for this agency, review of fiscal operations, operational plans and its quality assessment and performance improvement program.

Substantial Allegation Survey Substantial Allegation OH00118948 An entrance conference was conducted with administrative staff on 01/19/21 at 11:00 AM and an exit conference was conducted with administrative staff on 1/21/21 at 1:00 PM. The following deficiency is based upon substantial allegation OH00118948 completed on 01/21/21. Home Healthcare Dynamics LLC 369108, is not in compliance with the requirements found at 42 CFR Part 484 Subpart B, C for Home Health Agencies.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(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 medical record review, staff interview and policy review, the agency failed to promptly notify the physician of a change in the patient's condition for one of three patients reviewed (Patient #3). This could affect all patients receiving services from this agency. Findings include: The medical record for Patient #3 was reviewed on 01/21/21. The patient had a start of care date of 05/16/18 with diagnoses of cerebral infarct due to thrombus, Type I diabetes and history of seizures. The certification period reviewed was 11/01/2020 through 12/30/2020 and included orders for skilled nursing two times a day to monitor glucose levels, administer insulin due to poor vision, hand tremors, coordination and dexterity as well as no trained caregiver. Staff were to observe and assess skin integrity as well as observe and assess the patient's pain level each visit. A skilled nurse visit on 12/21/2020 at 7:23 AM revealed Patient #3's left thumb was swollen. Patient #3 stated she smashed her thumb between the wall and her wheel chair when rolling out of her room. Notes at 3:33 PM revealed the swelling continued to her left thumb and will continue to monitor. There was no documentation in the patient's record that a physician was notified of this injury. Skilled visit notes on 12/22/2020 at 6:40 AM revealed upon assessment the patient's left thumb remained swollen with a blister formed on her thumb, but again no physician notification was documented. Patient #3 was able to move her thumb and was encouraged to ice it to decrease the swelling. There was no documentation indicating how long the ice should remain on. The patient's plan of care stated this patient required ongoing re-directing with reminders. The plan of care further revealed the patient would require long term assistance with management of diabetes due to lack of understanding. Skilled visit notes on 12/23/2020 at 7:21 AM revealed a pain level of five out of ten to her left thumb which was throbbing. The nurse instructed the patient to continue icing her thumb and sent a fax to her physician regarding the swollen thumb. A request was made to Staff A during medical record review for confirmation or response from the physician. Staff A stated the physician did not respond to this fax and they usually did not respond. Assessments were completed and documented on 12/23/2020 at 7:21 AM and 4:14 PM indicating the swelling continued. Notes on 12/24/2020 at 6:00 AM revealed the patient's left thumb was swollen and bruised. The patient was complaining of a pain level of five out of ten The notes further revealed that Staff B asked Patient #3 if she would like to go to an emergency room (ER), but the patient refused at this time. Notes on 12/24/2020 at 3:16 PM revealed the patient's thumb continued to be bruised and swollen but she was able to move it with ice continuing. Skilled visit notes on 12/25/2020 at 6:00 AM revealed the patient's thumb continued to throb in pain, rated a five out of ten, and Patient #3 agreed to go to the ER later when her daughter arrived. A missed visit note was documented on 12/25/2020 at 3:30 PM with a note stating the patient was in the ER. Notes on 12/26/2020 by Staff C revealed Patient #3's services were on hold due to this patient being hospitalized. A note from Staff C on 12/30/2020 revealed the patient was discharged from this agency with a note that she remained hospitalized. The facility policy titled, Nursing Services, revised October 2017, was reviewed on 01/21/21. This policy instructed staff to inform the physician and other staff of changes in the patient's condition. A request for a policy regarding physician notification was made to Staff A on 01/21/21 at 5:30 PM. Staff A stated the only policy this facility had was the previous one under "Nursing Services" and staff usually faxed the physician. Staff A verified after reviewing the medical record for Patient #3 the no physician was notified until 48 hours after the nurse assessed the patient's injury. The policy instructed staff to notify the physician when a change in condition occurred. The findings of not notifying the physician promptly after a patient injured her thumb resulting in swelling, discoloration, bruising and a blister was verified in an interview with Staff A on 01/22/21 at 1:00 PM. This substantiates Substantial Allegation OH00118948.