Every finding on record at 21st Century Home Health LLC

Substantial Allegation Survey Substantial Allegation 61685 An entrance conference was conducted with administrative staff on 02/14/22 at 10:20 AM, and an exit conference was completed with the administrative staff on 03/03/22 The following deficiencies are based on the Substantial Allegation Survey completed on 03/03/22, 21ST Century Home Health LLC 369200 was not in compliance with regulations at CFR Part 484, Subpart B, C for Home Health Agencies. On 03/01/22 at 11:52 A.M. the Director of Nursing (DON) was informed a determination of Immediate Jeopardy was made under Infection Control. On 02/15/22 45.5% of the facility staff were unvaccinated against COVID-19 creating a likelihood of serious harm. An action plan was received on 03/02/22 and approved on 03/03/22 at 1:30 PM. On 03/03/22 at 3:15 PM, the DON was informed the Immediate Jeopardy was removed. 21st Century Home Health LLC is precluded from providing its own home health aide training and competency testing or competency evaluation program for a period of two years from the date of the receipt of the deficiency report (2567) for 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 QSO memo 22-09-ALL Attachment G, review of facility COVID-19 vaccination records, staff interview, and review of the facility policy, the facility failed to ensure at least 80% of the staff were vaccinated within 30 days from the effective date of the healthcare worker vaccine mandate. The agency’s percentage of unvaccinated staff for COVID-19 was 45.5%. (G687) Refer to G687 for deficient practice.

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 review of QSO memo 22-09-ALL Attachment G, review of facility COVID-19 vaccination records, staff interview, and review of the facility policy, the facility failed to ensure at least 80% of the staff were vaccinated within 30 days from the effective date of the healthcare worker vaccine mandate. The agency’s percentage of unvaccinated staff for COVID-19 was 45.5%. This affected 40 of 88 staff members (Director of Nursing, Home Health Aides #14, #15, #16, #17, #18, #19, #20, #21, #22, #23, #24, #25, #26, #27, #28, #29, #30, #31, #32, #33, #34, #35, #36, #37, #38, #39, #40, #41, #42, #43, #44, #45, #46, #47, #48, #49, #50; and Skilled Nurses #30, #31). Forty eight patients were receiving care from the 40 unvaccinated staff (Patients #3, #5, #6, #7, #8 , #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, #22, #23, #24, #25, #26, #27, #28, #29, #30, #31, #32, #33, #34, #35, #36, #37, #38, #39, #40, #41, #42, #43, #44, #45, #46, #47, #48, #49, #50, and #51). The agency census was 105. Review of QSO memo 22-09-ALL Attachment G, dated 01/14/22, revealed within 30 days of issuance of this memorandum, 100% of staff have received at least one dose of COVID-19 vaccine or have a pending request for, or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the Center for Disease Control and Prevention (CDC). Review of the agency policy titled “Covid-19 Vaccination Mandate Policy,” approved 01/10/22, revealed staff were to have received one dose of the COVID-19 vaccine prior to 02/14/22 and a second dose of the COVID-19 vaccine no later than 03/15/22. The policy also revealed the agency must demonstrate 100% compliance with the vaccination mandate. Review of staff vaccination records with the Director of Nursing (DON) on 02/15/22 at 10:07 AM revealed there were no COVID-19 vaccinations or exemptions on file for the following employees who provided direct patient care: DON; Home Health Aides #14, #15, #16, #17, #18, #19, #20, #21, #22, #23, #24, #25, #26, #27, #28, #29, #30, #31, #32, #33, #34, #35, #36, #37, #38, #39, #40, #41, #42, #43, #44, #45, #46, #47, #48, #49, #50; and Skilled Nurses #30, #31. Interview with the DON on 02/15/22 at 10:07 AM confirmed the staff identified above had not received the COVID-19 vaccination or had an exemption on file. The DON stated the facility plan, according to the policy, was that 100% of employees would be vaccinated by 03/15/22 or have exemptions on file. The DON further stated if staff had not started the vaccination series or received an exemption, they would be terminated. The DON also stated those with exemptions who would not receive the vaccination would be tested weekly and wear N-95 masks when in patients’ homes. The facility identified forty-eight patients receiving care from the 40 unvaccinated staff. (Patients #3, #5, #6, #7, #8 , #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, #22, #23, #24, #25, #26, #27, #28, #29, #30, #31, #32, #33, #34, #35, #36, #37, #38, #39, #40, #41, #42, #43, #44, #45, #46, #47, #48, #49, #50, and #51).

EMERGENCY PREPAREDNESS SURVEY At the time of the emergency preparedness survey completed on 11/18/21, 21st Century Home Health LLC is in compliance with the provisions of 42 CFR Part 484.102, Conditions of Participation for Home Health Agencies.

STANDARD RECERTIFICATION SURVEY SUBSTANTIAL ALLEGATION SURVEY SUBSTANTIAL ALLEGATION 61033 The following deficiency is based on the standard recertification survey of 11/18/21. No deficiencies were cited in regard to the allegations contained in substantial allegation 61033 completed on 11/18/21. 21st Century Home Health LLC 369200, is not in compliance with the requirements found at 42 CFR Part 484, Subpart B, C for Home Health Agencies.

Report all branch locations to SA CFR(s): 484.105(d)(1) The parent HHA is responsible for reporting all branch locations of the HHA to the state survey agency at the time of the HHA's request for initial certification, at each survey, and at the time the parent proposes to add or delete a branch. This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to report all branch locations to the state survey agency at the time the parent proposes to add a branch.. The agency census was 119. Findings include: Staff A stated in an interview upon entrance on 11/16/21 at 9:00 AM the agency had two operating branch locations and a CMS 855-A was submitted for approval on 02/21/20. The branches were located at 1234 West Main St. Newark, Ohio 43055 and 125 West Wood Boulevard, Suite C, Zanesville, Ohio 43701. Staff A provided evidence of the submitted CMS-855A dated 02/21/20, but was unable to provide an approval letter upon request. During the course of the survey it was discovered both branch locations had moved since the CMS- 855A was submitted on 02/21/20 and the new locations were 507 Main Street, Zanesville, Ohio 43701 and 1863 Cherry Valley Road, Newark, Ohio 43055. Staff A stated these were both recent moves and confirmed on 11/17/21 at 10:23 AM the branch locations had not been reported.