Every finding on record at Caring Hands Home Care Inc

A survey for compliance with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 4/21/25 to 4/23/25 during a recertification survey. The agency is in compliance with the Appendix Z Emergency Preparedness Requirements

On 4/21/25 to 4/23/25, a recertification and complaint survey was conducted. This resulted in a partial extended survey at Caring Hands Home Care. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The following complaints were reviewed with no deficiencies issued: H70712756 (98216), H70712757 (97514), H70712758 (97517) Unduplicated census previous 12 months: 144 Total home visits conducted: 03 List Parent Location visit. Caring Hands Home Care 113 Minnesota Avenue West Sebeka MN 56477 Other branch offices for this agency: Caring Hands Home Care---Branch visited and records were retrieved 602 E 1st St Park Rapids MN 56477 Hours of Operation: 8:00 a.m. to 4:00 p.m. Total number of records reviewed: 07

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 interview and document review the agency failed to encode and electronically transmit completed OASIS (Outcome and Assessment Information Set) assessments to the Center of Medicare and Medicaid (CMS) system within 30 days of completing the assessment of the patient for 5 of 5 (P8, P9, P10, P11, P12) patients sampled from Oasis Error Detail Report. The Center of Medicare and Medicaid (CMS) Outcome and Assessment Information Set (OASIS) Error Detail Report dated 1/1/24 through 12/31/24, identified 180 patients whose OASIS assessment records were submitted more than 30 days after the assessment had been completed. P8's plan of care (POC) identified a start of care date (SOC) of 11/8/22. P8's recertification OASIS assessment with completion date 10/28/24, was submitted to CMS 12/11/24, 44 days after completion of the assessment. P9's POC identified a SOC date of 11/18/20. P9's recertification OASIS assessment with completion date 10/29/24, was submitted to CMS 12/11/24, 43 days after completion of the assessment. P10's POC identified a SOC of 3/14/23. P10's recertification OASIS assessment with completion date 11/4/24, was submitted to CMS 12/11/24, 37 days after completion of the assessment. P11's POC identified a SOC of 10/24/24. P11's start of care OASIS assessment with completion date 10/29/24, was submitted to CMS 12/11/24, 43 days after completion of the assessment. P12's POC identified a SOC of 10/31/24. P12's start of care OASIS assessment with completion date 11/08/24, was submitted to CMS 12/11/24, 33 days after completion of the assessment. During interview on 4/21/24, at 2:00 p.m. owner/clinical manager (CM)-A stated she was responsible for submitting completed OASIS to CMS. CM-A had missed submitting some of the oasis. She had it on her agenda to do and then would get busy with other tasks and forget to get the OASIS submitted. CM-A thought she would need to just set one day a week adn submit any OASIS that were competed and she had not done that and so they were submitted late. CM-A thought when she on-boarded the new nurse she just hired, she may delegate the task of OASIS submissions to the new nurse, as she had a lot of experience with home care. Everything had gone hay wire the previous fall and CM-A just did not get the OASIS data submitted timely. The Center for Medicare and Medicaid Services OASIS E Manual, updated 1/1/24, identified OASIS data was collected as part of the comprehensive assessment required by the Medicare Conditions of Participation. The CMS Home Health Conditions of Participation required a home health agency electronically transmit accurate, completed, and encoded OASIS data to a centralized data submission system within 30 days of the completion of the assessment (M0090 Date Assessment Completed).

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 interview and document review, the agency failed to ensure each patient had an initial assessment visit within 48 hours of the referral date for 1 of 7 patients (P1) reviewed, in the sample. P1's plan of care (POC) 12/20/24 to 2/17/25, identified a start of care (SOC) date 12/20/24. Diagnoses included anxiety, post-traumatic stress disorder, attention deficit hyperactivity disorder, bipolar disorder and migraine. P1's clinical record identified a face-to-face physician visit was completed on 12/11/24, identifying P1 was in need of nursing home health services for difficulty with self-care and need for medication setup, however, P1 was not admitted to home care services until 12/20/24. The clinical record failed to identify a reason why P1 had not been assessed within 48 hours of the referral date of 12/11/24, and lacked evidence P1's physician was notified of the delay in the SOC date. When interviewed on 4/23/25, at 9:17 a.m. the owner/clinical manager (CM)-A indicated orders for home care services were received on 12/11/24, however, the agency did not have staff available to admit that week. CM-A was sure she had notified P1's social worker as well as his physician of the delay in SOC but had failed to document the telephone calls. The agency's practice was to contact the primary physician and get a verbal order for the delay in the SOC date, but CM-A was unable to find such an order for P1. The agency's undated policy, Admission of the Client to Home Care identified all persons referred would be considered for admission. Prospective client information would be received by the agency and reviewed by a registered nurse. Once the client was accepted, an RN would be assigned to complete the initial admission assessment and obtain initial signatures authorized care services, as well as establishing a service plan of care with the client. The policy lacked time frames for the initial assessment visit following receipt of a home care referral.

A survey with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 3/27/23, through 3/29/23 during a recertification survey. The facility is NOT in compliance with the Appendix Z Emergency Preparedness Requirements.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.542(b)(6), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to develop policy and procedures in the emergency preparedness plan to include the use of volunteers in an emergency or other emergency staffing strategies, as well as methods to contact off-duty staff during an emergency. This had the potential to affect all patients receiving services form the agency. The agency's undated Emergency Preparedness did not include information to address the use of volunteers in an emergency or procedures to contact off-duty staff during an emergency. During interview on 3/29/23, at 8:12 a.m. the agency director stated she was not aware this was a required component of an emergency preparedness plan, therefore, the agency had not included this information in their Emergency Preparedness policy.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to include the names and contact information for staff, entities providing services under arrangement, patients' physicians and volunteers in their emergency preparedness plan as required. This had the potential to affect all patients receiving care from the agency. The agency's undated Emergency Preparedness policy indicated staff, volunteers, law enforcement and others may be contacted in event of an emergency, however, contact information was not included. During interview on 3/29/23, at 8:12 a.m. the agency director stated she was not aware the contact information was needed to be included in the actual emergency plan and was a required component of an emergency preparedness plan, therefore, the agency had not included this information in their Emergency Preparedness policy.

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), §485.542(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 interview and record review, the agency failed to document contact information for federal, state, tribal, regional, and local emergency preparedness staff, as well as other sources of assistance. This had the potential to affect all patients served by the agency. The agency's undated Emergency Preparedness Policy and Procedure, identified local emergency response coordinators should be notified of any emerging needs of their patients, however, the policy did not identify their contact information During interview on 3/29/23, at 8:12 a.m. the agency director stated she was not aware the contact information was a required component of an emergency preparedness plan, therefore, the agency had not included this information in their Emergency Preparedness policy.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to conduct exercises to test their emergency plan as required. This had the potential to affect all patients receiving services from the agency. The agency's undated Emergency Preparedness policy, identified annual training would be provided to all their staff, however, did not identify methods the agency would participate in testing exercises of their plan, which would include a full scale community based exercise and/or an individual, facility-based functional exercise, as required. During interview on 3/29/23, at 8:12 a.m. the agency director stated she was not aware testing the emergency plan was a required component of an emergency preparedness plan, therefore, the agency had not conducted any testing exercises and had not included testing exercise in their Emergency Preparedness policy.

On 3/27/23, through 3/29/23, a recertification and complaint survey was conducted. This resulted in a standard, partial extended survey at Caring Hands Home Care. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. Unduplicated census previous 12 months: 191 Total home visits conducted: 03 Parent Location visited at 113 Minnesota Avenue West Sebeka MN 56447 Branch offices for this agency: 01 Caring Hands Home Care INC : branch visited over survey and records reviewed 602 E 1st ST Park Rapids MN 56477 List Hours of Operation: 8:00 a.m. - 4:00 p.m. List total number of records reviewed: 09 H70719664C Complaint 71532 was unsubstantiated.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, interview and document review, the agency failed to ensure a comprehensive assessment was conducted to ensure a change of condition was communicated to the patient's physician for 1 of 3 patients (P3) whose condition was reviewed during home visits. P3's plan of care (POC) for the certification dates 3/3/23-5/1/23, identified start of care (SOC) date of 1/12/21. During a home visit observation and interview on 3/28/23, at 11:00 a.m. registered nurse (RN)-A reviewed P3's vitals and general condition. P3 complained of a possible urinary tract infection (UTI) due to muscle spasms and nausea/vomiting. P3 stated she has had UTI's in the past and this was similar. RN-A collected an urinalysis (UA) sample using clean technique. RN-A stated P3 had frequent UTI's and her physician had provided a standing order for this and explained she would drop the sample at the lab and the physician would receive a result later that day. P3's POC did not identify a standing order for UA collection. P3's UA dated 3/28/23, identified abnormal white blood cells, red blood cells, bacteria and yeast. The form additionally identified it had been faxed to P3's physician, however, no additional information regarding P3's condition was provided to the physician. During a telephone interview on 3/28/23, at 2:02 p.m. RN-A stated P3 was able to set up her own medications and RN-A would not expect any communication from P3's physician to determine if P3 was treated or any follow up concerns. During an interview on 3/28/23, at 2:06 p.m. the agency director stated P3's medical record did not reflect communication to P3's physician regarding her current condition. P3's UA results were faxed to the physician; however, no other documentation was found. Additionally, the agency director stated communication and documentation was important because it identified what was done to treat a medical concern and/or continuity of care. An agency policy regarding a change of condition was requested but not provided.

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 observation, interview, and document review, the agency failed to ensure a comprehensive drug regimen review was conducted to ensure the accuracy of all medications/dosages for 2 of 3 patients (P4 and P3) whose medications were reviewed during home visits. P3's current Home Health Certification and Plan of Care dated 3/3/23, identified P3 was prescribed venlafaxine 75 mg tablets, take 3 tablets orally daily and venlafaxine 75 mg tablets take 2 tablets orally every morning along with 1 tablet orally at bedtime. During an interview on 3/28/23, at 11:35 a.m. registered nurse (RN)- A stated she asked P3 if she had any medication changes at every visit and did a full medication review during P3's recertification visit. If there were medication changes, RN-A might reach out to the provider for an order and add the medication to the medication list. During a telephone interview on 3/28/23, at 2:02 p.m. RN-A stated she did do a full medication review during P3's recertification on 3/3/23, however, "missed" venlafaxine was listed twice. RN-A stated she did not provide medication set-up for P3 and P3 was responsible to ensure she took her medications correctly. During an interview on 3/28/23 at 2:02 p.m. the agency director stated RN-A should be reviewing all medications in the home and comparing them to the orders. The director verified venlafaxine was listed twice and should have been identified by the nurse. The agency policy Medication Management undated, identified family may set up medications for their family member. When this was in place, staff noted on the Medication Service Plan of Care Addendum who was responsible for this and their phone number. Any medication order changes received by the agency would be called to that person. If there appeared to be "issues" with the service that family member was providing, request to meet with that person to discuss the concern. Differences between initial orders and information gathered must be reconciled. The nurse would contact the physician by phone, interim order, fax or memo to determine what was correct for the client. Medication reconciliation continued in an ongoing basis as medications were added, subtracted and/or changed. P4's plan of care (POC) 1/3/23, through 3/3/23, identified a start of care date (SOC) 5/29/18. Diagnoses included chronic obstructive pulmonary disease (COPD), diabetes, depression, and hypothyroidism. Medications included: zolpidem (sleep aid) 10 milligrams (mg) 1/2 to 1 tablet by mouth (po) as needed (prn), prednisone (steroid) 20 mg one tablet po two times per day (BID), tizanidine (muscle relaxant) 4 mg po three times (TID) daily, Tylenol PM two tables as directed on bottle, metformin (to treat diabetes) 750 mg two po every day (qd), omeprazole (acid reducer) 20 mg po qd, acetaminophen suppository (to treat pain or fever) retally every four hours prn, hydroxyzine (to treat itch) 25 mg po every three hours prn, lisinopril (for blood pressure) 20 mg po qd, Bisacodyl suppository 10 mg rectally qd prn, magnesium hydroxide 400 mg/5 milliliters (ml) 30 mg po prn, docusate 100 mg po BID prn, diclofenac (for pain) 50 mg BID, aluminum magnesium simethicone (acid reducer) 30 ml po every hour prn, Tylenol 325 mg two tablets po every four hours prn, albuterol inhaler (to treat shortness of breath) two puffs inhalation every six hours prn, aspirin (blood thinner) 81 mg po qd, Lipitor (cholesterol) 40 mg po qd. During a home visit on 3/27/23, at 2:00 p.m. P4 indicated she set up her own medications in a medication dispenser each week. P4 brought out her prescription medication bottles and stated she set all her medications each week according to the labels on each prescription bottle. She was aware of what each medication was prescribed for and what time and how often the medications were to be taken each day and indicated she was not taking prednisone, tizanidine or vitamin D3 as listed on her POC. The prescription medication bottles in her medication box were the only ones she set up and she was unsure when or if she had taken prednisone, tizanidine or vitamin D3. When interviewed on 3/29/23, at 8:31 a.m. registered nurse (RN)-B stated P4 had prednisone and tizanidine ordered at a physician appointment last fall when she had some kind of respiratory illness going on and it was ordered for a short time then discontinued. She had just forgotten to take it off P4's medication list or POC. P4 refused to take the Vitamin D3, but RN-B had not taken the medication off P4's POC or medication list either. During interview on 3/29/23, at 9:30 a.m. the agency director (AD) stated she expected the nurses to review patient medications at every visit and update the medication list as needed. A physician order should have been obtained to discontinue the P4's medication's when they were completed and the medications should have been taken off P4's medication list and POC. The agency's undated Medication Management policy indicated when patients were independent with medication management, the nurse would update the medication list as changes occurred. Change or new medications would be processed with interim orders being used to inform the physician of updates to the medication profile for the client during the 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 interview and document review, that agency failed to ensure visits were conducted in accordance with physician orders for 1 of 9 patients (P4) and failed to notify the physician when the visits were not conducted according to the plan of care (POC). P4's plan of care (POC) 1/5/23 through 3/5/23, indicated a start of care (SOC) date 1/5/23. Diagnoses included sepsis (infection of the blood), diabetes, malignant neoplasm of bladder (bladder cancer), acute kidney failure, and hypertension (high blood pressure). Services included skilled nurse visits (SNV) one time per week for one week, two times per week for two weeks then one time per week for six weeks. Physical and occupational therapy were to evaluate and treat. Therapy referrals were made to promote P4's strength and ability to regain his independence. A plan of care was to be established by each therapy. A physical therapy (PT) evaluation visit was made on 1/6/23. The POC indicated P4 would be seen by PT three times per week for four weeks, tapering visits down as appropriate. A PT re-evaluation visit was made on 1/20/23. A notation noted PT would decrease treatments to two times per week for two weeks and one time per week there after, however, the medical record lacked a physician order to decrease the frequency of therapy visits per week. Review of P4's therapy visits from 1/5/23 through his discharge on 2/16/23, indicated PT visits were performed three times per week through 1/20/23 and then two times per week through 2/1/23. P4's medical record lacked physician orders to decrease his PT visits to two times per week after 1/20/23, as well as to stop PT treatment after his 2/1/23, therapy visit. P4 was not discharged from the agency until 2/16/23, however, no further therapy visits were made after 2/1/23. P4's medical record lacked documentation the physician was notified when therapy decreased visits on 1/20/23, and stopped visits on 2/1/23. When interviewed on 3/28/23, at 3:15 p.m. the agency director (AD) stated she was unable to find the physician order to decrease or to stop P4's PT visits. It was expected to obtain physician orders to change the frequency and duration of a patient's services and she had just let the therapist know an order was expected and instructed therapy on the procedure to use. A physician order policy was requested, however not received.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on interview and document review the agency failed to identify specific performance measures for implementation to improve the patient outcomes related to medication safety, hospitalization, emergency room visits, nutrition, falls, and malnutrition as indicated on the tracking spreadsheet. This had the potential to affect all 191 patients receiving services from the agency. During entrance interview on 3/27/23, at 11:00 a.m. the agency director (AD) stated the agency quality assurance committee (QAPI) was only herself. She did work with the other nurses on it at times. She did not have a plan in writing, but was trying to review with the agency nurses regarding the new Outcome and Assessment Information Set (OASIS) (a patient specific standardized assessment form) and having them learn the changes that had occurred with the assessment form this year. She had put the new OASIS guidelines in a binder and was having the nurses review it when they found time. She hoped it would improve their OASIS submission errors but she was not measuring or analyzing any specific data items. The agency did not have QAPI meetings as it was just herself. When interviewed on 3/28/23, at 12:45 p.m. the AD stated the agency did not have formal QAPI problems documented and there were none to review from previous years. The program consisted of just herself and she figured out the issues she wanted to address. Besides working on reviewing OASIS guidelines, she thought to work on rehospitalizations and readmissions. She was working with someone on trying to get a formal QAPI program going but it wasn't there yet. There was no data being collected or evaluated to identify opportunities for improvement at the agency. No meetings had been held to discuss quality issues. The agency's undated Quality Management policy, indicated agency wide quality management activities included supervision of staff was carried out according to state and federal guidelines and agency policies and when issues were identified, agency policies for correction and discipline would be initiated. Specific quality management activities would include to participate in OASIS gathering of information for Home Care Compare and SHIP analysis of client survey results, participate in ongoing quality management study through Stratis service and internal monitoring through closed chart review, focused chart review and infection control monitoring and incident reporting. AD or designee would gather information and reports as needed. Individual quality management activities would have their respective reporting guidelines. Summary information would be shared with applicable staff in an ongoing manner during nursing meetings, circulated memos and/or direct conversation with individual staff. Ongoing educational activities would be provided for staff that would relate to quality management activities on an annual basis at a minimum. The agency's undated Quality Assessment and Performance Improvement (QAPI) policy indicated the agency would develop, implement, evaluate, and maintain an effective, ongoing agency wide data-driven QAPI program. The plan would be based on the organization's mission and goals and designed to improve client outcomes and the perceptions of clients/families about the quality and value of services. The agency would maintain documentary evidence of its QAPI program and be able to demonstrate its operation.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview and document review the agency failed to implement an infection control program that included tracking, trending and analysis of client and staff infections. When interviewed on 3/28/23, at 12:45 p.m. the agency director (AD) stated any patient illness was documented in the patient's individual chart. The agency tracked when staff or patients tested positive for COVID-19 but the agency did not keep track of any symptoms of illness or sick calls made by employees and did not keep logs of employee or patient illness or patient antibiotic use. The agency did not have an infection control program for tracking, trending and analysis of patient or staff infections. There was no plan based on surveillance findings, or how they would identify root cause of infections or disease transmission. She was not aware of the requirement to track and trend patient or staff reports of illness. The agency's undated Home Care Surveillance policy indicated the agency would establish a continuous data monitoring and collecting system to detect infections or identify changes in infection trends. The three types of surveillance which they may use were total surveillance of all infections identified in both clients and employees, targeted surveillance of specific infections, populations or procedures and outbreak surveillance for specific infections or infection clusters. The agency would attempt to identify the source of infection to determine if it was acquired while the client was receiving home care, from the community or during a recent hospitalization. An infection control log would be maintained. The agency would identify follow up actions taken as a result of identified infections. Information would be integrated into orientation in-service and quality improvement activities. Data related to identified infections would be reviewed and analyzed quarterly.

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 interview and document review, the agency failed to ensure two of six employees (E)-A, and E-B were vaccinated with a complete primary series of COVID-19 vaccine and/or had an approved or pending exemption on record. This resulted in a vaccination rate of 91% and had potential to affect all 191 patients receiving services from the agency. The Centers for Medicare and Medicaid (CMS) QSO-23-02-ALL, dated 10/26/22, identified the revised guidance for staff vaccination requirements. The QSO outlined the requirement for full staff vaccination had been enforced since February 2022, and listed a section labeled, "Vaccination Enforcement," which outlined, "CMS expects all providers' and suppliers' staff to have received the appropriate number of doses of the primary vaccine series unless exempted as required by law, or delayed as recommended by the CDC [Centers for Disease Control]. Facility staff vaccination rates under 100% constitute noncompliance under the rule." During the recertification survey, from 3/27/23 to 3/29/23, evidence of staff vaccinations was requested. An undated Staff COVID Vaccine Status listing, provided by the agency director (AD), demonstrated staff members vaccination status with completed primary series date(s), and any provided booster doses of COVID-19 vaccines, as well as staff members who did not have COVID-19 vaccination information listed. This listing identified a total of 17 staff members. Three staff (employee (E)-A, E-B, and E-C) of the 17 staff members did not have Covid-19 vaccine recorded at all. An approved religious exemption was documented for E-C, however, exemptions were not provided for E-A or E-B. AD stated E-A and E-B had not obtained their COVID-19 vaccinations and she did not have exemptions for either of the employees. She indicated it had been missed and she was in the process now to have them fill out exemption forms. The agency's undated COVID-19 Mandatory Vaccination policy indicated all employees were required to receive a COVID-19 vaccination unless a medical or religious exemption was approved. Employees not in compliance would be placed on unpaid leave until compliance was achieved.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to complete a comprehensive discharge assessment when the agency discharged a patient from skilled nursing care for 1 of 2 skilled patients (P7), reviewed. P7's plan of care (POC) for certification period 1/5/23 through 3/5/23, indicated a start of care (SOC) date 1/5/23. Diagnoses included sepsis, diabetes, history of bladder cancer, gastritis, kidney failure and hypertension. The POC indicated P7 received skilled nurse visits every one to two weeks for various assessments to manage multiple medical issues, coordination with physician appointments, safety in home and assist/teach caregiver. A physician order dated 2/16/23, indicated P7 had requested discharge from agency without a home visit for discharge assessment. P7's nephrostomy (tube in kidney to drain urine) and gastrostomy (feeding tube) had been removed and felt spouse could manage his care. The medical record lacked evidence of a comprehensive discharge assessment and summary was completed. When interviewed on 3/28/23, at 3:45 p.m. the agency director (AD) stated if a discharge summary was not in P7's medical record then it was not completed. The agency usually did a physician order to discharge a patient, however, did not complete a discharge summary at the time of discharge. The agency's undated Discharge policy, indicated the registered nurse (RN) case manager would complete a discharge summary that contained a comprehensive view of the patients total program, a summary of the social, emotional and behavioral adjustments relative to diagnosis, treatment, and rehab potential and anticipated outcomes toward recovery or further debilitation.