Every finding on record at Better Care Home Health and Hospice, Inc.

A recertification survey was conducted at Better Care Home Health Inc., located 49 Pleasant St, Leominster, MA 01453, on 5/27/25 and 5/28/25, for compliance with 42 CFR Part 484.102 Emergency Preparedness for Home Health Agencies. As a result of this survey, it was determined the agency was in compliance with the Condition of Participation for Emergency Preparedness. No deficiencies were cited.

A recertification survey was conducted at Better Care Home Health Inc., located at 49 Pleasant St., Suite A, Leominster, 01453, on 5/27/25 and 5/28/25, to determine compliance with the 42 CFR Part 488 requirements for Home Health Agencies. As a result of this survey, it was determined the agency was not in compliance with these requirements. Deficiencies were cited.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review, policy review and interview, the agency failed to ensure the participant, be informed about, and consent or refuse care in advance of and during treatment, for Occupational Therapy to furnish the care and services, for one Patient (#6), out of a total sample of 7 patients. Findings include: Review of the agency's policy entitled Plan of Care, dated 12/18/24, indicated the following: *The client, the therapist and other Better Care Home Health, Inc. personnel shall participate in developing the plan of care. The client shall be informed of any changes in the plan of care. Review of the agency's policy entitled, Consent For Use and Disclosure of Protected Health Information, dated 12/18/24, indicated the following: *Purpose: To access information needed to effectively provide services and provide documentation needed for reimbursement. *If consent cannot be obtained prior to treatment due to communication barriers or emergency situations, it will be obtained as soon as possible. Reasons why it is not signed must be documented. Patient #6 was admitted to the agency in March 2025 with a diagnosis of non-pressure chronic skin ulcer (impaired skin), requiring skilled services. Review of a physician's order dated 4/25/25, for a Physical Therapy (PT) and Occupational Therapy (OT) evaluation and treatment as indicated. Review of the clinical record indicated a PT evaluation was completed on 4/30/25 and an OT evaluation was completed on 5/1/25. Further review of the clinical record indicated a Consent for Assessment/Evaluation and Accepted for Treatment of PT services was obtained and signed by Patient #6 on 4/30/25, however there was no signed Consent for Assessment/Evaluation and Accepted for Treatment of OT services completed on 5/1/25 During an interview on 5/28/25 at 10:40 A.M., the Executive Director said the Occupational Therapist did not ensure Patient #6 had given consent to complete the evaluation and/or provide services as needed.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, policy review and staff interview, the agency failed to ensure that infection control guidelines were followed for one patient (#5) of 3 home visits conducted in a total sample of 7 records. Findings include: Review of the agency’s policy titled “OSHA Infection Control/Exposure Control Plan”, dated 12/18/2024, indicated the following: *Client infection control procedures shall include, but not limited to: -Wearing and changing gloves as necessary during the delivery of care. -Appropriate wound and skin care dressing techniques following sterile or aseptic dressing procedures. Review of the agency’s policy titled “Infection Prevention/Control”, dated 12/18/24, indicated the following: *Standard Precaution -Standard precaution apply to blood, all body fluids, secretions, excretions, non-intact skin, and mucus membranes. All are to be treated as a potential source of infection regardless of whether the client has a communicable disease. -Hands are washed if contaminated with blood or body fluids, immediately after gloves are removed. -Gloves are worn when touching blood, bloody fluids, secretions, excretions, non-intact skin, mucus membranes, or contaminated items. Patient #5 was admitted to the agency in 8/2024 with a primary diagnosis of Encounter for adjustment and management of vascular access devices. Review of the plan of care for certification period of 4/4/25-6/2/25, indicated skilled nurse visit for wound assessment and dressing change to the abdominal surgical site which included four open wounds (top midline, central midline, suprapubic midline, and right lower quadrant). The physician’s order for the treatment of the wounds included normal saline, pack open wounds with calcium alginate (a highly absorbent wound dressing) and cover with abdominal pads three times a week. On 5/28/25 at 9:30 A.M., a home visit was conducted with Registered Nurse (RN) #1 to perform wound assessment and dressing change to Patient #5. The surveyor observed RN #1 perform hand hygiene and put gloves on and set the dressing supplies (clean gauze, calcium alginate dressing, tape, and scissors) on the chair next to the patient. She removed the patient’s abdominal dressing, and she placed them on the chair next to the dressing supplies. RN #1 then removed the wound packing strips on all four open wounds that were visibly soiled, put it on the gauze and placed them on the chair next to the dressing supplies. Without changing her gloves, she obtained clean gauze and 10 milliliter (ml) of normal saline and squirted it into the surgical wounds and pat it dry with the gauze. RN #1 removed her gloves, performed hand hygiene and donned clean gloves. The surveyor observed RN #1 open and cut a sterile calcium alginate dressing to size to pack it to the open wounds. In the process of packing the top midline open wounds, the calcium alginate dressing fell out and touched the patient’s skin on the umbilical area making it contaminated. RN #1 then packed the top midline open wound with the same contaminated calcium alginate dressing. During an interview on 5/28/25 at 10:02 A.M., RN #1 said that she should have changed gloves and perform hand hygiene after removing the old dressing. She said that she usually has a trash bin next to her to throw away the old dressings and an extra pair of gloves to change. RN #1 said that she should have used a new calcium alginate dressing to pack the top midline open wound when it fell and got contaminated.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review, policy review and interview, the agency failed to ensure that the physician ordered plan of care was followed relative to Occupational Therapy (OT) services for 1 patient (#6), out of a total sample of 7 patients. Findings include: Review of the agency's policy entitled Plan of Care, dated 12/18/24, indicated the following: *Home care services are furnished under the supervision and direction of the client's physician. *Orders for therapy services shall include the specific procedures and modalities to be used and the amount, frequency and duration. Patient #6 was admitted to the agency in March 2025 with a diagnosis of non-pressure chronic skin ulcer (impaired skin), requiring skilled care. Review of a physician order dated 4/30/25 for a Physical Therapy and OT evaluation and treatment as indicated. Review of the clinical record indicated the OT evaluation was completed on 5/1/25. Further review of the evaluation included treatment plan for OT services once a week for 8 weeks effective 5/1/25. The evaluation indicated the physician was notified of the plan of care update and agreed to the order. Further review of the clinical record indicated an OT visit was not provided for the week of 5/4/25 through 5/10/25, and no documentation to indicate why the visit was not provided as ordered. During an interview on 5/28/25 at 10:45 A.M. the Executive Director (ED) said the plan of care had not been followed as ordered, as OT services were not provided during the week noted above. She said she spoke with the Occupational Therapist who indicated she did not do a visit that week and had not documented why it was missed.

An Emergency Preparedness survey was conducted at Better Care Home Health LLC from 6/8/22 through 6/9/22 for compliance with § 484.22 Emergency Preparedness for Home Health Agencies and the following deficiencies were cited:

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on policy review and interview, the agency failed to ensure the Emergency Plan included a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. Finding included: On 6/9/22 at 2:15 P.M., the surveyor, the Clinical Director and the Quality and Patient Safety Manager reviewed the agency's Emergency Preparedness (EP) plan. The Clinical Director said the plan did not include an agency and community based risk assessment utilizing an all-hazards approach.

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), §485.625(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 policy review and interview, the agency failed to ensure the Emergency Preparedness Plan included 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. Findings include: On 6/9/22 at 2:15 P.M. the surveyor, the Clinical Director and the Quality and Patient Safety Manager reviewed the Emergency Preparedness plan. The Clinical Director said the plan did not include a process the agency would ulitilize to help collaborate with their local, state, regional and federal disaster offiicals in the event of an actual emergency or disaster.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for 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:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure staff developed and documented an individualized emergency plan in the clinical record for seven Patients (#1, #2, #3, #4, #5, #6 and #7), out of total sample of seven patients. Findings include: Review of the clinical records for Patient #1 through #7 indicated no documented individual emergency plans. During an interview on 6/9/22 at 8:40 A.M., the Clinical Director said the agency staff had been preparing individualized emergency plans during a patient's initial visit. She said when the agency transitioned to an electronic medical record, the indiviudalized plans were not included in the new system and had been overlooked. She said that Patient #1 through #7 had no individualized emergency plans as required.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on policy review and interview, the agency failed to ensure the agency's Emergency Preparedness's communication plan included the contact information for the Federal, State, tribal, regional, and local emergency preparedness staff and other sources of assistance. Findings include: On 6/8/22 at 2:15 P.M., the surveyor, the Clinical Director and the Quality and Patient Safety Manager reviewed the agency's Emergency Preparedness (EP) Plan. The Clinical DIrector said the communication section of the EP plan did not include the required information for the Federal, State, tribal, regional, and local emergency preparedness staff.

Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(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: (4) A method for sharing information and medical documentation for patients under the [facility's] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility's] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). This STANDARD is not met as evidenced by: Based on policy review and interview the agency failed to ensure the Emergency Preparedness plan included a method for sharing information and medical documentation for patients under the agency's care, as necessary, with other health providers to maintain the continuity of care. Findings include: On 6/8/22 at 2:15 P.M., the surveyor, the Clinical Director and the Quality and Patient Safety Manager reviewed the agency's Emergency Prepared (EP) plan. The Clinical Director said the EP plan did not include a method the agency would use to provide a patient's medical needs to another health care provider so the patient could continue to receive the needed care and services.

Information on Occupancy/Needs CFR(s): 484.102(c)(6) §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(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: (7) [(5) or (6)] A means of providing information about the [facility's] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice's inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This STANDARD is not met as evidenced by: Based on policy review and interview, the agency staff failed to ensure the Emergency Preparedness (EP) plan included a means of providing information about the agency's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. Findings include: On 6/8/22 at 2:15 P.M., the surveyor, the Clinical Director and the Quality and Patient Safety Manager review the ageny's EP. The Director said the EP did not include the required method of providng information about the agency's need and it's ability to provide needed assistance, to a disaster command center.

A recertification survey, including compliance with staff vaccination requirements, was conducted at Better Care Home Health Inc, from 6/8/22 through 6/9/22. The agency was found to be non-compliant with the Federal Conditions of Participation Governing Home Health Agency. The following deficiencies were cited:

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview the agency staff failed to review all current medications for one Patient (#4) out of a total sample of seven patients. Findings include: Patient #4 was admitted to the agency in May of 2021. Review of the current physician orders for certification period, dated 4/29/22 through 6/27/22, indicated the agency staff failed to review the medications for any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effect, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. During an interview on 6/9/22 at 12:01 P.M., the Clinical Director said that Patient #4's medications had not been reviewed since he/she was admitted to the agency. She said all medications are supposed to be reviewed with every certification period.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview the agency staff failed to conform with the physician orders, specifically by not following the ordered home health aide visits for one Patient (#3) out of a total sample of seven patients. Findings include: Patient #3 was admitted to the agency in October 2021 with a diagnosis of obstructive and reflux uropathy (impaired urine flow). Review of a physician's order for certification period 2/22/22 through 4/22/22 indicated home health aide (HHA) services once a week for nine weeks. Review of the clinical record indicated HHA services were not provided during week ending 2/26/22, 4/9/22 and 4/16/22. The clinical record indicated the missed visit on 2/25/22 was due to inclement weather and the missed visits on 4/8/22 and 4/15/22 were due to HHA's illness. The clinical record did not indicate the missed visits were offered on alternative days during the week ending dates noted above. During an interview on 6/9/22 at 9:30 A.M., the Clinical Director said the HHA services were not provided as ordered during the three weeks ending dates noted above and no attempts were made for the services to be provided on alternative days. See G602.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure that staff did not provide nursing services, without a physician's order for one Patient (#3), out of total sample of seven patients. Findings include: Patient #3 was admitted to the agency in October 2021 with a diagnosis of obstructive and reflux uropathy (impaired urine flow). Review of a physician's order, dated 2/22/22, indicated skilled nursing services once a week for nine weeks. Review of the clinical record indicated the patient received nursing services on 3/7/22 and 3/9/22. Review of a nursing note, dated 3/9/22, indicated the nursing visit was an as needed (PRN) visit. Further review of the clinical record indicated there was not a physician's order for the PRN visit on 3/9/22. During an interview on 6/9/22 at 9:30 A.M., the Clinical Director said the nursing visit on 3/9/22 was done without a physician's order, and the nurse should have gotten an order for the visit.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure staff communicated with the physician when ordered home visits were missed for three Patients (#3, #6 and #4) out of a total sample of seven patients. Finding incude: 3. For Patient #4, the agency staff failed to communicate with the physician when skilled nursing visits were not completed as ordered. Patient #4 was admitted to the agency in May of 2021 with a primary diagnosis of a pressure ulcer (a wound caused by pressure) on the spine. Review of the physician's order for the certification period, dated 4/29/22 through 6/27/22, indicated skilled nursing two times a week for wound care. Review of the Patient #4's clinical record indicated the following; - Week ending 5/7/22, the patient was only visited one time, - Week ending 5/14/22, the patient was visited only one time, and - Week ending 5/20/22, the patient was visited only one time. During an interview on 6/9/22 at 1:15 P.M., the Clinical Director said the physician was not notified related to the missed skilled nursing visits. 1. Patient #3 was admitted to the agency in October 2021 with a diagnosis of obstructive and reflux uropathy (impaired urine flow). Review of a physician's order for certification period 2/22/22 through 4/22/22, indicated home health aide (HHA) services once a week for nine weeks. Review of the clinical record indicated HHA services were not provided during the following weeks: -Week ending 2/26/22. -Week ending 4/9/22. -Week ending 4/15/22. Further review of the clinical record indicated no documented communication to the patient's physician regarding the three missed HHA visits. During an interview on 6/9/22 at 9:30 A.M., the Clinical Director said the HHA services were not provided as ordered and the patient's physician had not been notified as required. 2. Patient #3 was admitted to the agency in April 2022 with a diagnosis of Trochanter Bursitis (inflammination of the fluid filled sac near the joint) of the right hip. Review of a physician's order for the certification period 4/20/22 through 6/18/22 indicated the following: -Skilled nursing services once a week for nine weeks. -Physical Therapy (PT) services two times a week for nine weeks. Review of the clinical record indicated the following: -PT services was only provided once during week ending 5/12/22. -Skilled nursing services were not provided for week ending 6/4/22. Further review of the clinical record indicated that staff had not notified the physician that they did not provide services as ordered. During an interview on 6/9/22 at 9:20 A.M., the Clincial Director said the missed visits were not communicated to the patient's physician as required.

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 policy review and interview the agency failed to develop policies and procedures that included the required components for infection control specifically related to Covid-19. Findings include: On 6/9/22 at 9:15 A.M., during review of the agency's Infection Control -Covid-19 policies, dated 10/15/21, the surveyor could not find the following required components to the policy; - A process for tracking and securely documenting the Covid-19 vaccination status of all staff. - A process for tracking and securely documenting the Covid-19 vaccination status of any staff who have obtained any booster doses. - A process for ensuring the tracking and secure documentation of the vaccination status of staff whom Covid-19 vaccination must be temporarily delayed. - A process for tracking and securely documenting the Covid-19 vaccination status of any staff who have obtained any booster doses. During an interview on 6/9/22 at 10:00 A.M., the Clinical Director said the agency did not have the above mentioned components to the Covid-19 policies.