Cardinal Home Health Services Inc.

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure: the initial assessment was completed within 48 hours of referral (see tag G0514); the comprehensive assessment was completed within 5 days of the SOC (see tag G0520); the comprehensive assessment included the patient’s current health status (see tag G0528); the comprehensive assessment included a review of all patient medications (see tag G0536); the comprehensive assessment included the assessment of the caregiver’s willingness, ability, and availability to provide care (see tag G0538); and the comprehensive assessment was revised after a change in condition (see tag G0544). The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care for the Condition of Participation 42 CFR 484.55 Comprehensive Assessment of Patients.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure: the POC was reviewed by the physician, individualized and followed by all agency staff (See tag G0572), the POC included all required information / elements for the treatment of the patient (See tag G0574), all treatments provided by agency staff were ordered by a physician (See tag G0580), and coordination of care for all services provided to the patient (See tag G0606). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination of Care and Quality of Care.”

“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), §485.542(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 record review and interview, the agency failed to ensure a process for collaboration and cooperation with local, state, and federal emergency preparedness officials in an effort to maintain an integrated response during an emergency. The findings include: The Emergency Preparedness Plan failed to evidence any collaboration or documented communication with local, state, and federal emergency preparedness officials since the change of ownership in June 2024. On 02/25/2025, at 2:45 PM, the CM/agency owner indicated she had not collaborated with local, state, and federal emergency preparedness officials since assuming ownership last year.”

“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 record review and interview, the agency failed to ensure the communication plan included contact information for the physicians and all services provided under arrangement. The findings include: The Emergency Preparedness Plan failed to evidence a communication plan to include contact information for the physicians and Entity 2 with whom the agency contracted therapy services. On 02/25/2025, at 2:45 PM, the CM indicated the Emergency Preparedness plan failed include contact information for the physicians and Entity 2.”

“EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to conduct exercises to test the emergency plan at least annually. The findings include: A review of the Emergency Preparedness Plan failed to evidence any testing exercise for 2024. On 02/25/2025, at 2:45 PM, the CM indicated the agency did not conduct any testing exercise in 2024.”

“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 record review and interview, the agency failed to electronically transmit the completed Outcome and Assessment Information Set (OASIS) assessment to the Centers for Medicare and Medicaid Services (CMS) system within 30 days of the completion of the patient assessment in 1 of 3 active clinical records reviewed with skilled services with a payor source of either Medicare or Medicaid and with an OASIS assessment completed more than 30 days. (Patient #2) The findings include: A clinical record review for Patient #2 evidenced a start of care OASIS assessment completed on 09/14/2024 which was transmitted more than 30 days after completion on 01/09/2025, a recertification OASIS assessment completed on 11/12/2024 which was transmitted more than 30 days after completion on 01/09/2025, and a recertification OASIS assessment completed on 01/09/2025 which the status indicated to be “export ready”. The clinical record failed to evidence the OASIS assessment completed on 01/09/2025 had been transmitted. On 02/24/2025, at 3:13 PM, the CM indicated the recertification OASIS assessment had not yet been transmitted and indicated she was aware the OASIS transmissions were behind schedule for some patients.”

“Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than- This Standard is not met as evidenced by: Based on record review, observation, and interview, the agency failed to ensure patients comprehensive assessment was updated, including collection of OASIS data elements, when patients’ status deteriorated and developed a stage II wound, for 1 of 1 active record reviewed who received SN, PT, and OT services and was admitted without a documented wound. [Patient #1] A clinical record review for Patient #1 evidenced a SOC comprehensive assessment dated 12/24/2024 and indicated the Patient had no wounds. Visit notes completed by COTA 1 dated 01/24/2025 and 01/27/2025 evidenced the Patient complained of pain 7/10 to the right heel and had recent treatment from Entity 1 and visit note dated 01/29/2025 indicated the Patient complained of pain 6/10 to the right heel. A PT visit note completed by PT 2 dated 01/24/2025 indicated the Patient complained of pain when bearing weight and indicated the Patient was not to bear weight on the right foot due to a wound. A skilled nursing visit note completed by the Alternate CM indicated the Patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (partial thickness) to the right heel. The clinical record failed to evidence a revision of the comprehensive assessment. During an observation of care at the Patient’s home on 02/19/2025, from 12:14 PM to 1:05 PM, the Alternate CM was observed performing wound care and 50% of the right heel had dry, thick, and yellow tissue peeling away exposing a dark red/purple area. Bright red drops of blood were observed dripping onto the floor. Patient #1 indicated their pain was 9/10 to the right foot and indicated they could not bear weight to the right foot due to the wound. On 02/19/2025, at 12:39 PM, the Alternate CM indicated the wound was not present at time of admission and was acquired while receiving home health services. On 02/21/2025, at 2:49 PM, the CM) indicated a new wound warranted a change in condition needing a revised comprehensive assessment and indicated there was not a revision completed.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop the POC in conjunction with the physician and failed to provide services as directed in the POC in 5 of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a POC for initial certification period of 12/24/2024-02/21/2025, which indicated OT and PT were to evaluate and treat. The PT POC and full evaluation completed by PT 2 on 12/27/2024 indicated the agency was to provide PT services 1 time a week for 1 week and then 2 times a week for 5 weeks; the record failed to evidence the PT reviewed the PT POC with the physician. The clinical record failed to evidence the POC was sent to the physician for review failed to evidence the agency provided PT services 2 times, as directed in the POC during the certification week of 01/26/2025. The OT POC and full evaluation, dated 01/08/2025, indicated the agency was to provide OT services 1 time a week for 1 week, 2 times a week for 4 weeks, and 1 time a week for 1 week. The clinical record failed to evidence the agency provided OT services after the OT evaluation, dated 01/08/2025, until 01/22/2025. On 02/21/2025, beginning at 2:57 PM, the CM indicated the PT should have called the physician for PT orders and indicated the PT POC was not sent to the attending physician. The CM indicated she was unsure why OT services were not provided after 01/08/2025, nor until 01/22/2025. The CM indicated there was a PT missed visit on 01/28/2025, and there were no documented attempts to reschedule the PT visit. On 02/26/2025, at 9:45 AM, PT 2 indicated he did not call the Patient’s physician to develop the POC, he indicated the agency should fax the PT POC, to the attending, for review. 2. A clinical record review for Patient #2 evidenced a POC for recertification period 11/13/2024-01/11/2025 which indicated the agency was to notify the physician of a systolic blood pressure (the pressure against the arteries when the heart is pumping and noted by the top number of a blood pressure reading) greater than 160. The recertification comprehensive assessment dated 01/09/2025 indicated the Patient’s systolic blood pressure was 193 in the right arm and 171 in the left arm and failed to evidence the agency notified the physician of the elevated blood pressure. The POC for recertification period 01/12/2025- 03/12/2025 indicated the agency would provide skilled nursing visits 1 time weekly to include review medications at every visit. The clinical record failed to evidence the agency provided skilled nursing visits during the weeks of 01/12/2025 and 02/09/2025. The skilled nurse visit notes dated 01/26/2025, 01/30/2025, and 02/06/2025 failed to evidence the skilled nurse reviewed the medications. On 02/24/2025, beginning at 3:07 PM, the CM indicated there was no documentation the agency notified the physician of the elevated blood pressure and indicated the nurse did not review the medications. The CM indicated she was unaware the skilled nursing visits were not provided for the weeks of 01/12/2025 and 02/09/2025. 3. A clinical record review for Patient #3 evidenced a POC for the initial certification period 02/07/2025-04/07/2025 which indicated the agency was to provide skilled nursing services 1 time a week for 9 weeks, and the PT POC for certification period 02/07/2025-04/07/2025 indicated the agency was to provide PT services 2 times a week for 5 weeks effective 02/11/2025. The clinical record failed to evidence any skilled nursing visits had been provided since the SOC assessment on 02/07/2025 and failed to evidence any PT visits since the PT evaluation on 02/11/2025. On 02/24/2025, at 3:23 PM, the CM indicated there were not any other nursing or PT visits documented, and she would check into it since she was not informed of any missed visits. No additional documentation or information was provided before survey exit on 02/26/2025. 4. A clinical record review for Patient #4 evidenced a POC for recertification period 01/30/2025-03/30/2025 which indicated the agency would provide skilled nursing services 2 times a week for 9 weeks. The clinical record failed to evidence the agency provided skilled nursing visits the week of 01/19/2025. On 02/24/2025, at 3:35 PM, the CM indicated there were no nursing visits documented the week of 01/19/2025 and she would check into it. No additional documentation or information was provided before survey exit on 02/26/2025. 5. A clinical record review for Patient #5 evidenced a POC for an initial certification period 01/14/2025-03/14/2025 which indicated the agency would provide nursing, HHA, PT, and OT services. An OT POC for an initial certification period of 01/14/2025-03/14/2025 indicated the agency was to provide OT services 1 time a week for 1 week, 2 times a week for 3 weeks, 1 time a week for 1 week, and 2 times a week for 3 weeks effective 1/20/2025. Week 2 beginning 01/26/2025 failed to evidence OT visits were provided and Week 4 beginning 02/09/2025 failed to evidence 2 OT visits were provided as directed in the POC. On 02/25/2025, at 2:27 PM, the CM indicated the COTA had difficulty reaching the patient and the OT visits were not provided. The CM indicated the other disciplines were able to complete their visits as directed in the POC, and the office manager eventually reached the patient to get the Patient’s input on scheduling preferences.”

“Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA’s governing body. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Governing Body approved the frequency and detail of the data collection and utilized quality indicator data from the OASIS Outcome and Assessment Information Set (OASIS) for the Quality Assessment Performance Improvement (QAPI) program. The findings include: The QAPI program and the Governing Body minutes failed to evidence the Governing Body approved the frequency and detail of the data collection. The QAPI program failed to utilize quality indicator data from the OASIS in the program’s design. On 02/25/2025, at 2:35 PM, the CM indicated there was no documented approval by the Governing Body of the frequency and detail of the data collection and indicated there was no incorporation of OASIS data in the program.”

“Program activities CFR(s): 484.65(c) (1) The HHA’s performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure performance improvement activities focused on high risk and problem-prone areas. The findings include: The Quality Assessment Performance Improvement (QAPI) program indicated hospitalizations increased from 5 in Quarter 3 2024 with an average patient census of 38 equaling 13% to 15 in Quarter 4 2024 with an average patient census of 52 equaling 29%. The QAPI program failed to evidence performance improvement activities related to the increased hospitalization rate. On 02/25/2025, at 2:35 PM, the CM indicated there were no performance improvement activities related to hospitalizations.”

“12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA completed 12 hours of in-service training in a 12-month period for 3 of 3 HHA personnel records reviewed out of a total 3 HHA actively employed with the agency. (HHA 1, HHA 2, and HHA 3) The findings include: The review of the agency’s in-service documentation binder evidenced HHA 1, date of hire 09/05/2019, completed 6 hours of HHA in-services in 2024, HHA 2, date of hire 11/04/2019, completed 4 hours of HHA in-services in 2024, and HHA 3, dated of hire 09/05/2019, completed 5 hours of HHA in-services in 2024. On 02/20/2025, at 2:01 PM, the CM indicated there was no additional HHA in-services completed in 2024.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the staff documented timely, into the clinical record, in 3 of 5 active clinical records reviewed. (Patient #1, 4, and 5) The findings include: 1. A policy revised February 2021 titled “Timely Submission of Patient Documentation” indicated visit reports should be submitted the next scheduled work day and was not to exceed 3 days. 2. A clinical record review for Patient #1 evidenced a PT Evaluation/Assessment completed by PT 2 and dated 12/27/2024; the clinical record failed to evidence PT 2 documented and submitted the assessment in the electronic health record [EHR] until 01/12/2025. The PT Discharge, dated 1/31/2025, was not completed and submitted by PT 2 until 02/09/2025. The OT Discharge was scheduled in the electronic health record for 02/11/2025; the status was “not yet started.” On 02/21/2025, beginning at 2:56 PM, the CM indicated the PT documentation should have been completed within 5 days. The CM indicated the OT had not yet started the documentation of Patients’ OT discharge. 3. A clinical record review for Patient #4 evidenced a POC for recertification period 01/30/2025 -03/30/2025 which indicated the agency would provide skilled nursing [SN] services 2 times a week for 9 weeks. The EHR evidenced SN visits were scheduled; and the status of the SN visit documentation for the dates 02/11/2025, 02/14/2025, 02/18/2025, and 02/21/2025 was “not yet completed.” On 02/24/2025, at 3:34 PM, the CM indicated the SN visits were completed, not yet documented. 4. A clinical record review for Patient #5 evidenced the agency provided skilled nursing and HHA services, and the last HHA supervisory visit in the electronic health record was completed on 01/28/2025. The EHR indicated SN visits were scheduled on 02/04/2025, 02/14/2025, 02/16/2025, 02/18/2025, 02/21/2025; the status of these visits was “not yet started” and failed to evidence any documentation for the visits. On 02/25/2025, at 2:28 PM, the CM indicated the Alternate CM completed a HHA supervision visit on 02/11/2025 and had not yet documented. The CM indicated the Alternate CM completed visits every Friday and the CM completed visits every Tuesday and had not yet documented the visits.”

“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 and interview, the agency failed to ensure the patient was informed of and consent to care in advance of treatment and with any changes in care in 5 of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5) The findings include: 1. The policy revised March 2018 titled “Consent for Treatment and Services” indicated the consent from at time of admission would be completed to include the disciplines and frequency of services to be provided. 2. A clinical record review for Patient #1 evidenced an OT POC for the initial certification period 12/24/2024-02/21/2025 which indicated the agency would provide OT services 2 times a week for 4 weeks. The Admission Consent dated 12/24/2024 indicated the agency would provide nursing and PT services and failed to evidence the frequency of visits to be provided and failed to evidence the agency was to provide OT services. On 02/21/2025, at 2:19 PM, the CM indicated the admission consent did not include OT and the frequency of services to be provided. A physician order from Entity 1 dated 01/28/2025 indicated skilled nursing was authorized 3 times a week for wound care. The clinical record failed to evidence the Patient was informed of the change in nursing frequency. On 02/21/2025, at 3:12 PM, the CM indicated there was no documentation the Patient was notified of the changes in nursing frequency. 3. A clinical record review for Patient #2 evidenced the Admission Consent dated 09/14/2024 which indicated the agency would provide skilled nursing services and failed to evidence the frequency of the visits to be provided. On 02/24/2025, at 3:12 PM, the CM indicated the frequency of services to be provided should be completed. 4. A clinical record review for Patient #3 evidenced a POC for the initial certification period 02/07/2025-04/07/2025 which indicated the agency would provide skilled nursing 1 time a week for 9 weeks, and the PT POC evidenced the agency would provide PT services 2 times a week for 5 weeks effective 02/11/2025. The clinical record failed to evidence the Admission Consent to inform the Patient of the services and frequency to be provided. On 02/24/2025, at 3:15 PM, th3 CM indicated the admission consent was not present in the clinical record. 5. A clinical record review for Patient #4 evidenced the Admission Consent dated 02/05/2024 which indicated the agency would provide skilled nursing and HHA services and failed to evidence the frequency of the services to be provided. On 02/24/2025, at 3:24 PM, the CM indicated the frequency of the services were not included on the consent form. 6. A clinical record review for Patient #5 evidenced the Admission Consent dated 01/14/2025 which indicated the agency would provide nursing, HHA, PT and OT services and failed to evidence the frequency of the services to be provided. On 02/25/2025, at 2:12 PM, the CM indicated the frequency of the services were not provided.”

“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 record review and interview, the agency failed to conduct an initial assessment visit within 48 hours of the referral in 1 of 3 active clinical records reviewed with a SOC since 12/01/2024. (Patient #1) The findings include: A clinical record review for Patient #1 evidenced the Patient was referred on 12/20/2024 and the initial assessment was not until 12/24/2024. On 02/21/2025, at 2:30 PM, the CM indicated the agency had difficulty reaching the patient to schedule the initial assessment visit and did not communicate with the physician regarding the delay in the SOC.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was completed within 5 days of the SOC in 1 of 1 active clinical record reviewed with OT services ordered at SOC since 01/01/2025. (Patient #5) The findings include: A clinical record review for Patient #5 evidenced a SOC physician order, dated 01/14/2025, which indicated OT was to evaluate and treat. The record failed to evidence the OT evaluation /assessment was completed, within 5 days of the SOC; the assessment was conducted by OT 2, dated 01/20/2025. On 02/25/2025, at 2:25 PM, the CM indicated she was unsure why the OT assessment was not completed within 5 days of the SOC.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on record review and interview, the agency failed to complete a comprehensive assessment to include the status of the wound in 1 of 1 active clinical records reviewed with a urinary catheter (a plastic tube inserted into the bladder to drain urine). (Patient #4) The findings include: A clinical record review for Patient #4 evidenced a skilled nursing visit note, dated 01/17/2025 and completed by the Alternate CM, indicated Patient had a foley catheter (a type of catheter that dwells in the bladder and is held in place by an inflated balloon). The recertification comprehensive assessment, completed by the Alternate CM and dated 01/28/2025, failed to evidence an assessment of the foley catheter to include the size, patency, amount and quality of the urine draining, and the size of the balloon. The comprehensive assessment indicated Patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (partial thickness) to the left thigh; the documentation failed to evidence an assessment of the size of the wound. On 02/24/2025, beginning at 3:25 PM, the CM indicated wound measurements were not documented in the comprehensive assessment and indicated the comprehensive assessment did not include an assessment of the foley catheter and should include the size, balloon size, patency, and urine amount. On 02/25/2025, at 7:49 AM, the Alternate CM indicated Patient did have a foley catheter.”

“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 failed to ensure the comprehensive assessment included a review of the medications to include drug interactions in 1 of 3 active clinical records reviewed with a SOC since 12/01/2024. (Patient #1) The findings include: A clinical record review for Patient #1 evidenced a SOC comprehensive assessment dated 12/24/2024 which indicated the Patient had no drug interactions. A POC for an initial certification period 12/24/2024-02/21/2025 indicated the Patient’s medications included: carvedilol (to treat heart failure), albuterol (to treat shortness of breath), spironolactone (to remove excess fluid), sildenafil (for erectile dysfunction), atorvastatin (for high cholesterol), and sacubitril-valsartan (for heart failure). A review of www.drugs.com indicated 12 drug interactions to include interactions between carvedilol and albuterol, carvedilol and spironolactone, carvedilol and sildenafil, carvedilol and sacubitril-valsartan, spironolactone and albuterol, atorvastatin and sacubitril-valsartan, sacubitril-valsartan and spironolactone, and sacubitril-valsartan and albuterol. On 02/21/2025, at 3:25 PM, the Administrator indicated the program used to check for medication interactions was not working for this patient’s medication review.”

“Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient’s primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included the assessment of the primary caregiver’s ability, willingness, and availability to provide care in 3 of 4 active clinical records reviewed with wounds. (Patient #1, 3, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a start of care comprehensive assessment dated 12/24/2024 which indicated the Patient needed assistance with bathing, grooming, dressing, and toileting and indicated the patient had diabetes (a chronic disease that affects the blood sugar) and was to check blood sugars. The comprehensive assessment indicated the patient lived with a caregiver and failed to include the assessment of the caregiver’s ability, willingness, and availability of personal and diabetic care. On 02/19/2025, at 1:02 PM, the Patient indicated they lived with a caregiver who worked during the day. On 02/21/2025, at 2:42 PM, the CM indicated the comprehensive assessment did not include what care the caregiver was providing. 2. A clinical record review for Patient #3 evidenced a SOC comprehensive assessment dated 02/07/2025 which indicated the Patient required assistance with activities of daily living and personal care, had diabetes and received insulin (medication for high blood sugar) injections daily, and had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (partial thickness) to the sacrum (lower back) requiring wound treatment. The comprehensive assessment indicated the Patient lived with the caregiver who provided care as needed and failed to assess the caregiver’s availability and ability to provide care to include wound care and insulin administration. On 02/20/2025, beginning at 10:47 AM, the Patient’s caregiver indicated they work and another family member comes to take care of the Patient. On 02/24/2025, at 3:16 PM, the CM indicated she was unsure what the caregiver’s availability and ability was to provide care because it was not documented in the comprehensive assessment. 3. A clinical record review for Patient #5 evidenced the SOC comprehensive assessment completed 01/14/2025 by the Alternate CM which indicated the Patient had an open wound to the left hip and indicated the nurse performed wound care by applying silver alginate and a dry dressing. The comprehensive assessment indicated the Patient lived with another person but failed to evidence the assessment of the Patient’s wound care. On 02/25/2025, at 2:21 PM, the CM indicated there was no assessment of who was providing wound care in the absence of the agency and indicated there was no assessment of the care the caregiver was willing and able to provide.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the POC was developed to include all the safety precautions, interventions, and measurable goals in 5 of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a POC for the initial POC which indicated OT was to evaluate and treat, and an OT POC for the initial certification period 12/24/2024-02/21/2025 indicated the agency would provide OT services 2 times a week for 4 weeks. The home health POC failed to include interventions and goals for the OT services. The POC indicated Patient’s medications included rivaroxaban (a medication used to thin the blood to prevent/treat blood clots) and failed to evidence bleeding precautions were included in the safety measures. A SOC comprehensive assessment indicated Patient received oxygen at 2 liters per minute as needed via a nasal cannula (a plastic tube inserted into the nose), and during an observation of care at Patient’s home on 02/19/2025, beginning at 12:14 PM, the oxygen concentrator was observed. The POC failed to include oxygen precautions in the safety measures. On 02/21/2025, beginning at 2:23 PM, the CM indicated the OT interventions and goals were not in the home health POC but in the specific OT POC and indicated the oxygen and bleeding precautions were not included in the POC. 2. A clinical record review for Patient #2 evidenced a POC for recertification period 01/12/2025-03/12/2025 which included PT interventions and goals and the clinical record failed to evidence PT services were being provided. On 02/24/2025, at 3:02 PM, the CM indicated the PT interventions and goals should not be included in the POC and were a carry-over from a previous certification period when the Patient received PT services. 3. A clinical record review for Patient #3 evidenced a SOC comprehensive assessment completed by the Alternate CM on 02/07/2025 which indicated the Patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (partial thickness) to the sacrum (lower back). The comprehensive assessment indicated the Alternate CM provided wound care to the sacrum by applying medi-honey (wound ointment) and a dry dressing. The comprehensive assessment indicated the Patient had diabetes and received insulin (medication for high blood sugar) injections daily, The POC for the initial certification period 02/07/2025-04/07/2025 failed to include the wound to the sacrum, wound treatment, and interventions and goals related to the wound and diabetes management. The POC indicated the primary diagnosis for home health was malignant neoplasm of the endometrium (cancer of the uterus lining) and failed to include interventions and goals related to the primary diagnosis. On 02/25/2025, beginning at 3:22 PM, the CM indicated the POC did not include the pressure ulcer to the sacrum and the interventions and goals related to the wound, diabetes, and the primary diagnosis. 4. A clinical record review for Patient #4 evidenced skilled nurse visit notes dated 12/31/2024, 01/07/2025, 01/10/2025, 01/15/2025, and 01/17/2025 completed by the Alternate CM which indicated the Patient had a pressure ulcer stage IV (full thickness exposing bone and/or tendon) to the left thigh. The visit note dated 12/31/2024 indicated the nurse performed wound care to include applying a wound vacuum dressing (a medical device that vacuum seals to the wound to apply negative pressure and remove excess drainage) to the left thigh. Visit notes dated 01/07/2025, 01/10/2025, 01/15/2025, and 01/17/2025 indicated the nurse applied silver alginate (an absorbent, antimicrobial wound treatment) and a dry dressing to the left thigh wound. The POC for recertification period 01/30/2025-03/202/2025 failed to evidence the wound, wound treatment, and goals related to the wound. On 02/24/2025, at 3:25 PM, the CM indicated the POC did not include the wound, wound treatment order, and goals related to wounds. 5. A clinical record review for Patient #5 evidenced a POC for initial certification period 01/14/2025-03/14/2025 which indicated the agency would provide HHA services 2 times a week for 9 weeks and failed to evidence interventions and goals for the HHA services. The POC indicated the patient’s primary diagnosis was cellulitis (deep skin infection) of the back and failed to evidence interventions and goals related to the primary diagnosis. The SOC comprehensive assessment completed 01/14/2025 by the Alternate CM indicated the Patient had an open wound to the left hip and indicated the nurse performed wound care by applying silver alginate and a dry dressing. The POC failed to evidence the wound and wound treatment. On 02/25/2025, beginning at 2:13 PM, the CM indicated there were no interventions and goals related to the primary diagnosis and the HHA services. The CM indicated the wound and wound treatment order was not included in the POC.”

“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 care was provided as directed by a physician in 2 of 4 active clinical records reviewed with a wound. (Patient #1, 3) The findings include: 1. A clinical record review for Patient #1 evidenced a physician order from Entity 1, dated and faxed to the agency on 01/28/2025, which indicated skilled nursing was ordered and authorized for wound care consisting of medi-honey (a wound ointment) and a padded dry dressing 3 times per week to the right heel pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin). The agency failed to provide wound care until 2/5/2025; per the skilled nursing visit note, the SN which failed to evidence the treatment was provided as ordered. Skilled nursing visit notes dated 2/7/2025, 2/12/2025, and 2/14/2025 also failed to evidence medi-honey was applied as ordered. The agency failed to provide nursing services 3 times a week during the weeks of 2/2/2025 and 2/9/2025. On 02/21/2025, at 9:27 AM, the Alternate CM indicated she was unsure when she was notified by the Administrator of Patient #1’s wound and treatment orders. The Alternate CM indicated she did not see the wound care order until present at the patient’s house where the order and supplies were present on 02/05/2025. On 02/21/2024, at 3:04 PM, the CM indicated she was unsure why skilled nursing services were not provided 3 times a week per the order on 01/28/2025. 2. A clinical record review for Patient #3 evidenced a SOC comprehensive assessment completed by the Alternate CM on 02/07/2025 which indicated Patient had a pressure ulcer stage II (partial thickness) to the sacrum (lower back). The comprehensive assessment indicated the Alternate CM provided wound care to the sacrum by applying medi-honey and a dry dressing. The clinical record failed to evidence a physician order for wound care. On 02/24/2025, at 3:21 PM, the CM indicated there was not a wound care order in the clinical record. On 02/25/2025, at 7:49 AM, the Alternate CM indicated she knew what wound care to perform, the caregiver instructed her to what wound care was provided in the hospital, prior to admission to home health. The Alternate CM indicated there was no communication with Patient’s physician regarding wound care.”

“Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This Element is not met as evidenced by: Based on record review and interview, the agency failed to coordinate care with all healthcare providers providing care in 1 of 1 clinical record reviewed with another home care company providing care (Patient #1) and in 1 of 1 clinical record reviewed with a LPN providing services (Patient #2). The findings include: 1. A clinical record review for Patient #1 evidenced a POC for the initial certification period of 12/24/2024 – 02/21/2025 which indicated the agency was to provide: SN services 1 time a month for 3 months for a full assessment, PT services 2 times a week for 5 weeks, and effective 01/08/2025 OT services 2 times a week for 4 weeks. Visit notes, completed by COTA 1 and dated 01/24/2025 and 01/27/2025, evidenced Patient complained of pain 7/10 to their right heel and had recent treatment from Entity 1. The visit note dated 01/29/2025 indicated Patient complained of pain 6/10 to their right heel. A PT visit note completed by PT 2 and dated 01/24/2025 indicated Patient complained of pain when bearing weight and indicated Patient was not to bear weight on the right foot due to a wound. The clinical record failed to evidence COTA 1 and PT 2 coordinated care with the OT, nurse case manager, and Entity 1 related to the wound. On 02/21/2025, at 9:40 AM, PT 2 indicated he was informed by the Patient of a wound on the right foot at the visit on 1/24/25, did not notify the nurse case manager regarding the wound since Patient #1 had a dressing in place to the right foot, and Patient #1 reported they received treatment at their physician’s office. On 02/21/2025, at 11:24 AM, COTA 1 indicated she did not communicate with the nurse case manager related to the wound, because she assumed nursing was providing wound care. COTA 1 could not definitely remember if she informed the occupational therapist about the wound. On 02/21/2025, at 10:25 AM, OT 2 indicated COTA 1 did not inform her of the Patient’s wound and increased pain. On 02/21/2025, at 3:04 PM, the CM indicated there was no coordination with Entity 1 and the Patient’s physician regarding the wound until 02/21/2024 when the agency requested documentation of the patient’s wound treatment. The SOC comprehensive assessment dated 12/24/2024 indicated the patient required assistance with bathing, dressing, and grooming. The clinical record failed to evidence any coordination with any other agency providing HHA services. On 02/19/2025, at 12:43 PM, Patient indicated she/he received HHA services 3 times a week on Monday, Wednesday, and Friday from another Entity. On 02/19/2025, at 12:43 PM, the Alternate CM indicated she believed Entity #1 was providing the HHA services. On 02/21/2025, at 2:54 PM, the CM indicated she was unaware the Patient was receiving HHA services and indicated there was no care coordination. 2. A clinical record review for Patient #2 evidenced a SN visit note completed by LPN 1, dated 01/26/2025, which indicated Patient reported a recurring rash and indicated the only new medication was Pepcid (to treat reflux). The record failed to evidence LPN 1 coordinated care with the RN case manager of a possible medication side effect. On 02/25/2025, at 7:49 AM, the Alternate CM/Patient’s nurse case manager indicated she was not aware of a rash due to a possible medication side effect and stated, “That’s [LPN 1’s] patient.””

“Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA provided services as directed in the care plan in 1 of 2 active clinical records reviewed with HHA services. (Patient #5) The findings include: A clinical record review for Patient #5 evidenced a HHA Care Plan dated 01/14/2025 which indicated the HHA was to provide oral care, incontinent care, and range of motion at every visit. HHA visit notes completed by HHA 1 dated 01/15/2025, 01/17/2025, 01/20/2025, 01/24/2025, 01/29/2025, 02/01/2025, 02/05/2025, 02/08/2025, and 02/12/2025 indicated the HHA did not provide oral care, incontinent care, and range of motion as directed in the care plan and indicated the HHA provided a shampoo and hair care which was not included in the care plan. On 02/25/2025, at 2:25 PM, the CM indicated the HHA did not follow the care plan as directed.”

“Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient’s plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA was supervised no less frequently than every 14 days when HHA services were provided along with skilled services in 1 of 2 active clinical records reviewed with HHA services. (Patient #4) The findings include: A clinical record review for Patient #4 evidenced a POC for recertification period 01/30/2025-03/30/2025 which indicated the agency would provide skilled nursing and HHA services both 2 times a week for 9 weeks. The clinical record evidenced skilled nursing services were provided on 01/31/2025, 02/04/2025, and 02/07/2025 and HHA services were provided 02/01/2025, 02/03/2025, 02/08/2025, 02/09/2025, 02/15/2025, and 02/16/2025. The record failed to evidence supervision of the HHA since 01/28/2025. On 02/24/2025, at 3:34 PM, the CM indicated there was no other documented HHA supervision since 01/28/2025.”

“HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient’s plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient’s condition; and (vi) Honoring patient rights. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA supervision included the HHA followed the aide care plan in 1 of 2 active clinical records reviewed with HHA services. (Patient #5) The findings include: A clinical record review for Patient #5 evidenced a HHA Care Plan dated 01/14/2025 which indicated the HHA was to provide oral care, incontinent care, and range of motion at every visit. HHA visit notes completed by HHA 1 dated 01/15/2025, 01/17/2025, 01/20/2025, and 01/24/2025 indicated the HHA did not provide oral care, incontinent care, and range of motion as directed in the care plan and indicated the HHA provided a shampoo and hair care which was not included in the care plan. The HHA supervision visit dated 01/28/2025 and signed by the Alternate CM indicated the HHA provided services per the care plan and failed to evidence the RN provided supervision to ensure the HHA followed the aide care plan as directed. On 02/26/2025, at 11:53 AM, the Alternate CM indicated she was not aware HHA 1 did not provide services as directed in the care plan and indicated she did not review the HHA visit notes.”

“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 record review and interview, the agency failed to provide to the physician the discharge summary within 5 business days of discharge from the agency in 2 of 2 closed records reviewed. (Patient #6, 7) The findings include: 1. A clinical record review for Patient #6 evidenced a discharge summary dated 01/08/2025 which indicated the agency discharged the Patient on 12/31/2024 and failed to evidence the agency sent the discharge summary to the physician. 2. A clinical record review for Patient #7 evidenced a discharge summary dated 12/30/2024 which indicated the agency discharged the Patient on 12/26/2024 and failed to evidence the agency sent the discharge summary to the physician. 3. On 02/25/2025, beginning at 2:31 PM, the CM indicated there was no documentation the discharge summary was sent to the physician for either Patient #6 or Patient #7.”