Every finding on record at Ohio First Home Healthcare, Inc

Extended Substantial Allegation Survey Substantial Allegation Number 71658 An entrance conference was conducted with administrative staff on 09/20/22 at 1:00 PM, and an exit conference was completed with administrative staff on 09/30/22 at 4:45 PM. The following deficiencies are based upon substantial allegation 71658 completed on 09/30/22. Ohio First Home Healthcare, Inc 368370, is not in compliance with the requirements at 42 CFR Part 484, Subpart B, C for Home Health Agencies. Ohio First Home Healthcare, Inc is precluded from offering its own home health aide training and/or competency evaluation program for a period of two years from the exit date of this survey.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on medical record review, facility policy review, and staff interview, the facility failed to ensure a registered nurse conducted an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status within 48 hours of a patient's referral to the agency for one of three patient records reviewed (Patient #1). This could affect all patients receiving services from the agency. The agency census was 97. Findings include: Review of the medical record for Patient #1 revealed a Referral form for home health services from a rehabilitation hospital. It noted an admission date to the hospital of 07/14/22 and a discharge date of 08/15/22. The fax details at the top of the page revealed the form was faxed to the home health agency on 08/15/22 at 7:50 AM. The discharge diagnoses included infected sacral decubitus ulcer, diabetes mellitus, aphasia following cerebral infarction, and flaccid hemiplegia of left nondominant side as late effect of cerebral infarction. Although the referral form noted the patient was discharged on 08/15/22 and the form was faxed on 08/15/22 at 7:50 AM, the initial assessment was not completed until 08/18/22, 72 hours after the referral. Staff A and Staff B were interviewed on 09/30/22 at 4:00 PM. It was confirmed that the initial assessment should have been completed within 48 hours of receiving the referral.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on medical record review, facility policy review, and staff interview, the facility failed to ensure a registered nurse practiced according to the agency's policies and procedures for one of three patients reviewed (Patient #1). This could affect all patients receiving services from the agency. The agency census was 97. Findings include: Review of the medical record of Patient #1 revealed the start of care assessment on 08/18/22 noted the patient had three wounds on the left sacral region. The wound care worksheet noted wound one, on the left sacral and buttock, was a stage 4 pressure ulcer (a deep wound that reaches the muscles, ligaments, or bones) with undermining. There were no measurements noted for this wound. Wound two, on the left sacral buttock, measured 3 centimeters (cm) x 2 cm x 0.00. The wound stage was 2 (loss of dermis presenting as a shallow open ulcer with a red-pink wound bed or open/ruptured serum-filled blister). The third wound, on the posterior right hip, was also classified as a stage 2. Like the first wound, there were no wound measurements for this wound. In the comment section of the wound care worksheet, the following was noted, "Wound care provided by other entity hired by family." It was further noted that this agency was only responsible for documenting the progress of wounds for continuity of care. The medical record lacked documentation a provider was updated about the patient's wounds. The undated agency policy titled, Wound Assessment and Documentation, was reviewed on 09/21/22 at 4:40 PM. According to the policy, nurses are instructed that the initial assessment of wound including measurements may be done by the Registered Nurse (RN), Licensed Practical Nurse (LPN) or Therapist who found the wound. The physician will be notified after the initial assessment completed on the same day as the initial wound findings. The policy also instructs nursing staff to complete wound measurements every week. Staff A and Staff B were interviewed on 09/22/22 at 3:05 PM. It was confirmed that the medical record lacked documentation the patient's wounds were measured as required. It was also confirmed that the medical record lacked documentation a provider was informed of the patient's extensive sacral wounds as required. This deficiency substantiates Substantial Allegation 71658.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on medical record review and staff interview, the agency failed to ensure home health aides provided services included in the plan of care (G800). The agency failed to ensure a home health aide reported changes in a patient's condition to a registered nurse (G804). The cumulative effect of these systemic practices resulted in the agency's inability to ensure the patient's needs would be met.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on medical record review and staff interview, the agency failed to ensure home health aides provided services included in the plan of care for one of three patients reviewed (Patient #1). This could affect all patients receiving services from the agency. The agency census was 97. Findings include: Review of Patient #1's medical record revealed the patient was originally admitted for services of the agency on 06/02/20. The certification period of 11/24/21 to 01/22/22 noted the patient was admitted with diagnoses that included cerebrovascular disease, urinary incontinence, essential hypertension, and muscle weakness. The patient was ordered to have services of an aide 41 hours a week to provide assistance with activities of daily living. The Aide Care Plan, signed by a registered nurse on 11/19/21, instructed the home health aide to turn or position the patient every visit. Review of the home health aide clinical notes revealed that from 11/21/21 through 11/27/21, for a total of 41 hours, there was no documentation the patient was turned or positioned. This was confirmed with Staff A and Staff B during an interview on 09/22/22 at 4:30 PM. This deficiency substantiates Substantial Allegation 71658.

Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. This ELEMENT is not met as evidenced by: Based on medical record review and staff interview, the agency failed to ensure a home health aide reported changes in a patient's condition to a registered nurse for one of three patients reviewed (Patient #1). This could affect all patients receiving services from the agency. The agency census is 97. Findings include: Review of the medical record of Patient #1 revealed the patient was admitted for services of the agency on 08/18/22. Review of the Aide Care Plan, signed by a registered nurse on 08/19/22, revealed that a registered nurse or provider should be notified if the patient had not had a bowel movement in three days. Review of the home health aide clinical notes revealed that from 08/18/22 through 08/27/22, for a total of 80 hours, there was no documentation a registered nurse, provider, or any staff member at the home health agency was notified that the patient had not had a bowel movement. The patient's hospital medical record was retrieved and reviewed. The patient was transported via squad to the facility's emergency department (ED) on 08/27/22. The ED triage note stated the son reported concerns for possible fecal impaction and urinary tract infection. The son, who was present at the patient's bedside, reported that the patient had not had a bowel movement in over a week. The son also stated that the patient complained of abdominal pain earlier that day. The patient also reported "that she had not had BM in a long time." Upon palpation of the patient's abdomen, there was an area of firmness noted in her right lower quadrant. A computed tomography scan revealed "moderate colonic stool burden" consistent with fecal impaction. The findings were confirmed in an interview with Staff A and Staff B on 09/30/22 at 4:00 PM. This deficiency substantiates Substantial Allegation 71658.

Substantial Allegation Survey Substantial Allegation Number 62251 Extended Survey The following deficiencies are based on the Federal Vaccine Mandate QSO 22-09- All review, completed on 04/12/22 at Ohio First Home Healthcare. No deficiencies were issued in regard to allegations contained in substantial allegation 62251 investigated concurrently. On 04/11/22 at 2:30 P.M. the Administrator was informed of Immediate Jeopardy under Infection Control. On 04/11/22, only 40 percent of the facility staff were vaccinated against COVID-19, creating a likelihood of serious harm. An action plan was received and approved on 04/12/22. On 04/12/22 at 3:30 P.M., the Administrator was notified the Immediate Jeopardy was removed on 04/12/22 when the staff were educated on the agency's COVID-19 vaccine policy. The agency is precluded from offering its own aide training and/or competency evaluation program for a period of two years from the exit date of this survey.

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 review of the Centers for Medicare & Medicaid Services (CMS) memorandum QSO-22-09-ALL Attachment G, record review and staff interview, the facility failed to develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19 and failed to ensure at least 100 percent of the staff were vaccinated within 90 days from the effective date of the healthcare worker vaccine mandate. The agency’s percentage of vaccinated staff for COVID-19 was 40 percent. (G 687). The cumulative effect of these systemic practices resulted in the agency's inability to ensure that the patients' infection control needs would be met.

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 the unprecedented global pandemic that resulted in the Presidential declaration of a State of National Emergency dated 03/13/20, review of the Centers for Medicare & Medicaid Services QSO memo 22-09-ALL Attachment G, review of facility COVID-19 vaccination records, and staff interview, the facility failed to ensure all staff were fully vaccinated against COVID-19 at 100 percent compliance within the effective date of the healthcare worker vaccine mandate. Additionally, the agency failed to develop any COVID-19 vaccination policies and procedures, failed to develop a process to track and document information provided by staff requesting exemptions and who agency has granted, failed to develop a process to ensure all documentation confirms clinical contraindications, supports staff request for medical exemptions and must be signed and dated by the Physician, failed to develop a process to document and evaluate religious exemptions, and failed to develop a process to track and document staff where vaccine is delayed, as recommended by the CDC. The agency’s percentage of vaccinated staff for COVID-19 was 40%. This affected 49 (Staff A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y, Z, AA, BB, CC, DD, EE, FF, GG, HH, II, JJ, KK, LL, MM, NN, OO, PP, QQ, RR, SS, TT, UU, VV, WW, XX, and YY) of 82 staff members. This affected 55 patients (#1, #2, #3, #4, #6, #8, #9, #13, #14, #16, #17, #18, #19, #20, #21, #23, #25, #26, #27, #30, #32, #35, #37, #40, #42, #43, #44, #45, #46, #49, #50, #51, #52, #55, #56, #57, #58, #59, #60, #61, #63, #67, #69, #70, #72, #75, #76, #77, #79, #81, #83, #84, #85, #86 and #90) who were receiving care from 47 unvaccinated home health aide staff, one registered nurse and one contracted occupational therapy staff. The agency census was 90. Findings include: Review of QSO memo 22-09-ALL Attachment G, dated 01/14/22, revealed, within 60 days of issuance of this memorandum, the agency must demonstrate policies and procedures are developed and implemented for ensuring all agency staff, regardless of clinical responsibility or resident contact are vaccinated for COVID-19 and 100% of staff have received the necessary doses to complete the vaccine series, 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). Interview with Staff ZZ on 04/11/22 at 10:29 AM revealed the agency did not have 100 percent of staff status for COVID-19 compliance with either vaccination or exemption status established. Staff ZZ said agency staff had been provided with forms and information about the need to provide documentation of their status to the agency. On 04/11/22 Staff ZZ said the current figures were 33 of 82 staff had a documented status, for a rate of 40 percent of known status. Staff ZZ confirmed that 60 percent of agency employees did not have a documented vaccine status regarding the mandated vaccine requirements. Review of the agency’s COVID-19 tracking log and policy for screening revealed the agency had some employee documentation on record and that accounted for the 40 percent of known staff status, but 60 percent of staff had no documentation regarding their status in compliance with the COVID-19 mandated requirements. Review of the agency’s policy revealed there was no guidance for the expectation for obtaining a status in writing, use of personal protective equipment (PPE) by staff, nor any guidance specific to the staff who were not vaccinated (exempted), or any protocols for staff who failed to comply by providing a documented status. Review of a current patient list on 04/12/22 revealed a total of 49 staff persons without a documented vaccination status were assigned to and providing scheduled care for 55 patients. This data was gleaned from a total of 82 agency staff and a census of 90 patients. Staff ZZ assisted and confirmed this data review by noting which staff were assigned to which patient. Review on 04/11/22 of the Home Health Agency’s Employee Roster revealed there were 52 current employees. Review on 04/11/22 of the Home Health Agency’s employee vaccination cards revealed 33 of the 82 employees were fully vaccinated. The agency vaccination rate was calculated at 40%. There were no COVID-19 vaccinations or exemptions on file for the following staff who provided direct patient care (Staff A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y, Z, AA, BB, CC, DD, EE, FF, GG, HH, II, JJ, KK, LL, MM, NN, OO, PP, QQ, RR, SS, TT, UU, VV, WW, XX, and YY ). Interview with Staff ZZ on 04/11/22 at 10:29 AM confirmed Staff A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y, Z, AA, BB, CC, DD, EE, FF, GG, HH, II, JJ, KK, LL, MM, NN, OO, PP, QQ, RR, SS, TT, UU, VV, WW, XX, and YY had not received the COVID-19 vaccination or had an exemption on file. Staff ZZ identified 55 patients, Patients #1, #2, #3, #4, #6, #8, #9, #13, #14, #16, #17, #18, #19, #20, #21, #23, #25, #26, #27, #30, #32, #35, #37, #40, #42, #43, #44, #45, #46, #49, #50, #51, #52, #55, #56, #57, #58, #59, #60, #61, #63, #67, #69, #70, #72, #75, #76, #77, #79, #81, #83, #84, #85, #86 and #90 who were receiving care from the unvaccinated home health aide staff.