Every finding on record at Omni Home Care Agency Inc

An unannounced complaint survey, complaint number 2022013765, was conducted on 09/15/22 to 09/16/22 at Omni Home Care Agency Inc., a Home Health Agency in Miami, Florida. Omni Home Care Agency Inc. was not in compliance with 42 CFR 484 Subpart A-C requirements for Home Health Agencies (HHA). Complaint number 2022013765 contained 5 allegations that were substantiated. The patient census on 09/15/22 was 28. Immediate Jeopardy is a situation in which the provider’s noncompliance with one or more requirements has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient. Immediate Jeopardy (IJ) situations were identified during the survey for the agency due to the provider’s failure to ensure a patient being provided with skilled nursing services for the assessment and administration of wound care compliance. The HHA’s Licensed Practical Nurse documented on 08/19/22 sacrum wound measurement Size (L[length] x W[width] x D[depth]) as 2.5 x 2.5 x 0.5; then on 08/26/22 sacrum wound measurement documented as 3 x 2.5 x 0.5 and noted on both notes “drainage small, surrounding tissue pink; no signs or symptoms of infection noted/reported.” The Licensed Practical Nurse documents on 08/28/22 “drainage small, surrounding tissue pink / dark; no signs or symptoms of infection noted”. The Licensed Practical Nurse failed to notify the ordering physician of changes in wound condition as documented on service note date 08/19/22 of the wound depth size had increased from 0.3 to 0.5; then on 08/26/22 the length size increased from 2.5 to 3; then once again on 08/28/22 the wound’s surroundings tissue changed from pink to pink/dark. The Licensed Practical Nurse documented on 09/01/22 “drainage dark; tunneling dark; odor foul; surrounding tissue dark”; “signs or symptoms of infection noted/reported. MD [medical director] present during wound care and decide remitted to the hospital”. The patient was admitted to the emergency department on 09/01/22 with description “patient brought for sacral wound infection” and further noted “patient taken 09/02/22 for debridement of sacral pressure injury, measures 8.0 x 6.0 x 3.0 coccyx palpated, undermining from 6 to 12 o’clock 3.5 cm. The patient presented to the emergency room with right shoulder pressure injury stage 2, wound base pink, no drainage, no odor, periwound with fading redness; has right lateral ankle stage 2 1.0 x 1.0 x 0.1 wound base pink, scant drainage, no odor; and blisters right/left knees and legs.” Immediate Jeopardy was identified at COPs [Condition of Participation] G406, G570 and G700. The Administrator/owner was informed of the ongoing immediate jeopardy on 09/21/22 at 3:31 PM. The following is a description of the non-compliance.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: This CONDITION is not met as evidence by: Based on interview, clinical record review and review of policies and procedures, it was determined that the Home Health Agency (HHA) failed to obtain the patient's or legal representative's signature (Refer to G418); and failed to have patient or legal representative participate in, be informed about, and consent or refuse care in advance of and during treatment (Refer to G434). The cumulative effect of these systemic practices resulted in the agency's inability to protect and promote the exercise of these rights by the patient(s) and representative (if any) would be met.

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to demonstrate it had obtained the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities for 2 out of 3 Sampled Patients (SP). SP#1 and SP#3 Findings include: Clinical records review was conducted from 09/15/22 to 09/16/22 of SP#1 and SP#3. Closed clinical record review of SP#1 revealed a start of care date 08/12/2022 with the Client Service Agreement signed and dated 08/12/2022. Active clinical record review of SP#3 revealed a start of care date 03/10/2018 with the Client Service Agreement signed and dated 03/10/2018. Further review of SP#1 and SP#3 records both contained a consent form that under “Relationship of Authorized Representative” was left blank. The Director of Nursing on 09/15/22 reviewed the consent forms and stated the ALF (assisted living facility) Administrator signed the consents. Interview conducted with Director of Nursing (DON) and Administrator on 09/16/22 at 3:45 PM. The DON and Administrator confirmed the signature on the service agreement form is the ALF Administrator's signature and not the patient's legal representative for SP#1 and SP#3. Telephone interview was conducted with the ALF Administrator on 09/20/22 at 3:42 PM. The ALF Administrator confirmed that she signed the consent for service for SP#1 and SP#3. The ALF Administrator acknowledged that she is not the patients’ legal representative.

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 home health agency failed to demonstrate it had the patient(s) and the patient’s legal representative participate in, be informed about, and consent or refuse care in advance of and during treatment of the care to be furnished, the completion of all assessments, the care to be furnished based on the comprehensive assessment, and the disciplines that will furnish the care and the frequency of visits for 2 out of 3 Sampled Patients (SP). SP#1 and SP#3 Findings include: Clinical records review was conducted from 09/15/22 to 09/16/22 of SP#1 and SP#3. Closed clinical record review of SP#1 revealed a start of care date 08/12/2022 with the Client Service Agreement signed and dated 08/12/2022. Active clinical record review of SP#3 revealed a start of care date 03/10/2018 with the Client Service Agreement signed and dated 03/10/2018. Further review of SP#1 and SP#3 records both contained a consent form that under “Relationship of Authorized Representative” was left blank. The Director of Nursing on 09/15/22 reviewed the consent forms and stated the ALF (assisted living facility) Administrator signed the consents. Interview conducted with Director of Nursing (DON) and Administrator on 09/16/22 at 3:45 PM. The DON and Administrator confirmed the signature on the service agreement form is of the ALF Administrator's signature and not the patient's legal representative for SP#1 and SP#3. The DON and Administrator acknowledges that provider is unable to demonstrate the patient’s legal representative participated and were informed of all aspects of the planned care and services.

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: This CONDITION is not met as evidence by: Based on interview, clinical record review and review of policies and procedures, it was determined that the Home Health Agency (HHA) failed to develop an individualized Plan of Care that must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment (Refer to G572 and G574). The HHA failed to assure communication with the patient’s physician and coordinate care delivery to meet the patient’s needs (Refer to G590 and G602). The cumulative effect of these systemic practices resulted in the agency’s inability to ensure the implementation and coordination of the patient’s individualized plan of care needs would be met.

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 home health agency failed to develop an individualized Plan of Care (POC) that identifies patient-specific measurable outcomes and goals for 1 out of 3 Sampled Patients (SP). SP#2 Findings include: Clinical record review was conducted from 09/15/22 to 09/16/22 of SP#2 revealed the patient was referred to the home health agency for skilled nursing and physical therapy services with prescriptions that read “RN (registered nurse) evaluation and treatment teaching medication injection insulin; wound care at lt (left) leg 3 times / week; and Physical Therapy evaluation and treatment”. Review of the service schedule calendar revealed a Start of Care Assessment scheduled for Registered Nurse with date 09/10/22, and Initial Evaluation for Physical Therapy with date 09/10/22. Further review of the clinical record revealed that no Plan of Care (POC) was established and available for review by all staff involved in providing care to the patient. Interview conducted with the Director of Nursing on 09/15/22 at 11:38 AM stated the POC is almost completed, pending the physical therapist evaluation to finish.

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 home health agency failed to include in the individualized plan of care the following: 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; and information related to any advanced directives on 2 out of 3 Sampled Patients (SP). SP#1 and SP#3 Findings include: Clinical records review conducted on 09/15/22 to 09/16/22 of SP#1 and SP#3 contained a Plan of Care (POC) that omitted the patient's risk for emergency department visits and hospital re-admission; information related to any advanced directives. Interview conducted with the Administrator and Director of Nursing on 09/16/22 at 3:45 PM acknowledged that the POC’s are missing the required information as previously stated.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to promptly alert the relevant physician of the patient's condition or needs that suggest the plan of care should be altered for 1 out 3 Sampled Patients (SP). SP#3 Findings include: Clinical record review was conducted from 09/15/22 to 09/16/22 of SP#3 revealed the Plan of Care (POC) reads for skilled nurse to provide “Skilled Nurse to prepare/administer insulin subcutaneous injection daily”. Review of the clinical record for date range 06/19/22 to 08/27/22 of the skilled nurse service notes revealed the patient was receiving insulin injection in the early morning (7-8am), then as of 06/26/22 to 08/27/22, the nurse documents providing the insulin injection at noon (12-1pm), then once again as of 08/28/22 to present the nurse documents providing the insulin injection in the early morning (7-8am). Further review of the record omitted case conference notification that the ordering physician was notified of the change in time for the insulin administration. A telephone interview was conducted with the Licensed Practical Nurse (LPN) [Staff A] that provides nursing care to SP#3 on 09/15/22 at 3:43 PM. As per LPN (STAFF A), she is providing insulin to SP#3 in the morning. The LPN (STAFF A) stated that she had personal issues and could not go in the morning and therefore was going at noon time. The LPN (STAFF A) added that it was just a few days that occur. The LPN (STAFF A) was informed that it was 2 months’ time span. The LPN (STAFF A) then stated that she couldn’t remember exactly how long that occurred. The LPN (STAFF A) stated that she did not communicate the time change of the insulin administration to anyone in the home health agency. On 09/16/22 at 2:0 PM the Director of Nursing confirmed that LPN (STAFF A) had not notified the agency of the change in the insulin administration schedule. Telephone interview was conducted with the Administrator of the Assisted Living Facility were SP#3 resides on 09/20/22 at 12:17 PM. The Administrator confirmed that SP#3 has gotten the insulin injection in the morning for a very long time. The Administrator stated that she was surprised to know the LPN (STAFF A) was going at noon and not in the morning as usual, adding that the LPN (STAFF A) never told her a reason for the change in the time schedule. The Administrator states that LPN (STAFF A) informed her that SP#3 could have the insulin at any time between morning and noon because the patient was only getting it once a day.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to demonstrate coordination of care delivery and communication with the patient's physician involved in the plan of care for 1 out of 3 Sampled Patients (SP). SP#2 Findings include: Clinical record review was conducted from 09/15/22 to 09/16/22 of SP#2 revealed the patient was referred to the home health agency for skilled nursing and physical therapy services with prescriptions that read “RN (registered nurse) evaluation and treatment teaching medication injection insulin; wound care at lt (left) leg 3 times / week; and Physical Therapy evaluation and treatment”. Review of the service schedule calendar revealed a Start of Care Assessment scheduled for Registered Nurse with date 09/10/22, an Initial Evaluation for Physical Therapy with date 09/10/22 and the Licensed Practical Nurse (LPN) [Staff C] commenced servicing SP#2 09/11/22 to present. It was inquired from the Director of Nursing (DON) on 09/15/22 at 11:38 am if SP#2 was receiving the wound care nursing service. The DON answered that SP#2 refused for the nurse to provide wound care. Further review of the record omitted case conference(s) that show effective communication and coordination with the patient’s relevant ordering physician and the home health agency staff. A telephone interview was conducted on 09/15/22 at 11:40 AM with the Registered Nurse (RN) [Staff B] that provided the Start of Care Assessment of 09/10/22. The RN (Staff B) stated that the patient informed him that he gets wound care done at wound care center and didn’t allow him to see the wounds on bilateral lower extremities. The RN was inquired if he notified the ordering physician of this (not able to provide wound care because patient refused care) and the nurse stated that he did not call the physician. Interview with the DON on 09/15/22 at 12:37 PM stated that the LPN (Staff C) stated that on her first day of providing care to SP#2, she called the ARNP, to notify that patient refused the wound care and wants to continue only with the wound care being provided at the wound care center 2 times a week. Interview with the DON on 09/15/22 at 1:15 PM. The DON confirmed that she called the wound care center for SP#2 and clarified the wound care service. The DON states that the physician’s nurse informed her that SP#2 goes to the wound care center sometimes unannounced to receive wound care to bilateral lower extremities. The nurse states that patient would benefit from agency nurse to provide the wound care at home and decrease the visits to the wound care center. Telephone interview was conducted on 09/15/22 at 1:54 PM with the advanced registered nurse practitioner (ARNP) that establish the home health treatment orders for SP#2. The ARNP was inquired if notification was done by the home health agency staff that SP#2 refused the wound care upon admission to service. The ARNP stated “no” and added that she is aware of SP#2 going to the wound care center 1 to 2 times a week, and that the home health care order for nurse to provide wound care was done in order to have patient comply with the wound care frequency of 3 times a week.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to demonstrate documentary evidence of its Quality assessment and performance improvement (QAPI) that lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. Findings include: Clinical record review was conducted of SP#1 and SP#3 on 09/15/22 to 09/16/22. SP#1 record review revealed patient was admitted on 08/12/22 for skilled nurse service to provide wound care daily to sacrum area. The Registered Nurse (Staff B) on 08/12/22 completed the initial comprehensive assessment that revealed “pressure ulcer on sacrum / skin tear on left forearm” [page 3 of 29]. Further review of the clinical record omitted documentation of the skin tear on the left forearm being reported to the patient’s ordering physician. The Plan of Care reads “Skilled nurse to notify immediately if any worsening of the skin lesion or increased drainage of the wound is noted. Skilled nurse to take measurement/character of the wound at least once a week and report if signs/symptoms of infections or the other complications are noted”. The Registered Nurse (Staff B) on 08/12/22 completed the initial comprehensive assessment that revealed on [page 12 of 29] “reported date 08/07/22, location: Sacrum, Size (L[length] x W[width] x D[depth]) 2.5 x 2.5 x 0.3, Tunneling and Undermining were left blank; Stage (pressure ulcers only): unstageable; Severity of ulcer (exclude pressure ulcers): skin only, fatty tissue; Odor: none; Surrounding Skin: pink; Edema: none; Appearance of wound bed was left blank; Drainage: small; Color: serosanguineous; Consistency: thin. Further review of the clinical record omitted documentation of the skin tear on the left forearm being reported to the patient’s ordering physician. The Licensed Practical Nurse (Staff A) commenced providing wound care to SP#1 on 08/15/22. The Staff A documented on 08/19/22 sacrum wound measurement (LxWxD) as 2.5 x 2.5 x 0.5; then on 08/26/22 sacrum wound measurement documented as 3 x 2.5 x 0.5 and noted on both notes “drainage small, surrounding tissue pink; no signs or symptoms of infection noted/reported.” The Staff A documents on 08/27/22 “wound care complete healed. MD [medical doctor] notified”. On 08/28/22 the Staff A documents “drainage small, surrounding tissue pink / dark; no signs or symptoms of infection noted”. On 08/29/22 the Staff A documents that “drainage dark, surrounding tissue red, odor foul; skilled nurse report signs or symptoms of infection noted. And contact MD and notified wound infection.” The clinical record for SP#1 omitted documentation that the ordering physician was notified of changes in wound condition as documented on Staff A’s service note date 08/19/22 of the wound depth size had increased from 0.3 to 0.5; then on 08/26/22 the length size increased from 2.5 to 3; then once again on 08/28/22 the Staff A documents on the service note that wound’s surroundings tissue changed from pink to pink/dark. The Staff A failed to notify the ordering physician of all changes in the sacrum wound condition as early as 08/19/22 in order to have prevented the noted infection as documented by the Staff A on 08/29/22 as “drainage dark, surrounding tissue red, odor foul; skilled nurse report signs or symptoms of infection noted. And contact MD and notified wound infection.” Telephone interview was conducted on 09/15/22 at 11:45 AM with Staff B confirmed that patient had skin tears on left arm, but it was mostly redness and dry. The Staff B confirmed that the skin tears were not reported to the physician because they didn’t require wound care. On 09/15/22 the Staff B provided a picture taken at admission on 08/15/22 of the left arm skin tears that were observed to be 5 open areas with pink to beefy red appearance on the inner aspect of forearm [4 open areas] and inner aspect of arm [the humerus area, 1 open area]; and a picture of the sacrum that was observed on the picture the wound bed was covered with yellow slough tissue. On 09/15/22 at 3:23 PM a telephone interview was conducted with the Staff A. The Staff was read the notation of “wound healed, MD [medical doctor] notified” noted on service note dated 08/27/22 and the Staff A stated it must have been by error written, that was incorrect. SP#3 record review revealed the Plan of Care ordered skilled nursing service daily for 60 days for diabetic care. Further review of the clinical record for date range 06/19/22 to 09/15/22 showed no progress notes from the Licensed Practical Nurse (Staff A) from date(s) 07/31/22 to 09/10/22. Interview conducted with the Director of Nursing on 09/15/22 at 3:40 PM acknowledged findings made by surveyor. The DON added that the nurse needs to submit the nursing notes. Interview conducted with the Director of Nursing (DON) on 09/16/22 at 2:41 PM acknowledged errors in staff writing the notes, and of the care rendered and of late notes by staff. The DON confirmed that provider is unable to demonstrate an effective ongoing quality assurance at the time of the survey visit.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: This CONDITION is not met as evidence by: Based on interview, clinical record review and review of policies and procedures, it was determined that the Home Health Agency (HHA) failed to provide ongoing interdisciplinary assessment of the patients (Refer to G706) and provide services that are ordered by the physician (G710). The HHA staff failed to prepare and record clinical notes; and failed to communication with the patient’s physician and coordinate care delivery to meet the patient’s needs (Refer to G716 and G718). The cumulative effect of these systemic practices resulted in the agency’s inability to ensure the patient’s skilled professional service(s) would be met.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to demonstrate the skilled professionals assumed responsibility for conducting ongoing interdisciplinary assessment of the patients for 3 out of 3 Sampled Patients (SP). SP#1, SP#2 and SP#3 Findings include: Clinical record review was conducted of SP#1, SP#2 and SP#3 on 09/15/22 to 09/16/22. SP#1 record review revealed patient was admitted on 08/12/22 for skilled nurse service to provide wound care daily to sacrum area. The Registered Nurse (Staff B) on 08/12/22 completed the initial comprehensive assessment that revealed “pressure ulcer on sacrum / skin tear on left forearm” [page 3 of 29]. Further review of the clinical record omitted documentation of the skin tear on the left forearm being reported to the patient’s ordering physician. Telephone interview conducted on 09/15/22 at 11:45 AM with Staff B confirmed that patient had skin tears on left arm, but it was mostly redness and dry. The Staff B confirmed that the skin tears were not reported to the physician because they didn’t require wound care. On 09/15/22 the Staff B provided a picture of the left arm skin tears that were observed to be 5 open areas with pink to beefy red appearance on the inner aspect of forearm [4 open areas] and inner aspect of arm [the humerus area, 1 open area]. Telephone interview conducted on 09/15/22 at 2:01 PM the Licensed Practical Nurse (Staff A) that provided wound care to SP#1 effective 08/15/22 stated that patient did not have skin tears to left arm. SP#2 record review revealed the patient was referred to the home health agency for skilled nursing and physical therapy services with prescriptions that read “RN (registered nurse) evaluation and treatment teaching medication injection insulin; wound care at lt (left) leg 3 times / week; and Physical Therapy evaluation and treatment”. Review of the service schedule calendar revealed a Start of Care Assessment scheduled for Registered Nurse with date 09/10/22, an Initial Evaluation for Physical Therapy with date 09/10/22 and the Licensed Practical Nurse (LPN) [Staff C] commenced servicing SP#2 09/11/22 to present. It was inquired from the Director of Nursing (DON) on 09/15/22 at 11:38 am if SP#2 was receiving the wound care nursing service. The DON answered that SP#2 refused for the nurse to provide wound care. Further review of the record omitted case conference(s) that show effective communication and coordination with the patient’s relevant ordering physician and the home health agency staff. A telephone interview was conducted on 09/15/22 at 11:40 AM with the Registered Nurse (RN) [Staff B] that provided the Start of Care Assessment of 09/10/22. The RN (Staff B) stated that the patient informed him that he gets wound care done at wound care center and didn’t allow him to see the wounds on bilateral lower extremities. The RN was inquired if he notified the ordering physician of this (not able to provide wound care because patient refused care) and the nurse stated that he did not call the physician. Interview with the DON on 09/15/22 at 12:37 PM stated that the LPN (Staff C) stated that on her first day of providing care to SP#2, she called the ARNP, to notify that patient refused the wound care and wants to continue only with the wound care being provided at the wound care center 2 times a week. Interview with the DON on 09/15/22 at 1:15 PM. The DON confirmed that she called the wound care center for SP#2 and clarified the wound care service. The DON states that the physician’s nurse informed her that SP#2 goes to the wound care center sometimes unannounced to receive wound care to bilateral lower extremities. The nurse states that patient would benefit from agency nurse to provide the wound care at home and decrease the visits to the wound care center. Telephone interview was conducted on 09/15/22 at 1:54 PM with the advanced registered nurse practitioner (ARNP) that establish the home health treatment orders for SP#2. The ARNP was inquired if notification was done by the home health agency staff that SP#2 refused the wound care upon admission to service. The ARNP stated “no” and added that she is aware of SP#2 going to the wound care center 1 to 2 times a week, and that the home health care order for nurse to provide wound care was done in order to have patient comply with the wound care frequency of 3 times a week. Clinical record review was conducted from 09/15/22 to 09/16/22 of SP#3 revealed the Plan of Care (POC) reads for skilled nurse to provide “Skilled Nurse to prepare/administer insulin subcutaneous injection daily”. Review of the clinical record for date range 06/19/22 to 08/27/22 of the skilled nurse service notes revealed the patient was receiving insulin injection in the early morning (7-8am), then as of 06/26/22 to 08/27/22, the nurse documents providing the insulin injection at noon (12-1pm), then once again as of 08/28/22 to present the nurse documents providing the insulin injection in the early morning (7-8am). Further review of the record omitted case conference notification that the ordering physician was notified of the change in time for the insulin administration. A telephone interview was conducted with the Licensed Practical Nurse (LPN) [Staff A] that provides nursing care to SP#3 on 09/15/22 at 3:43 PM. As per LPN (STAFF A), she is providing insulin to SP#3 in the morning. The LPN (STAFF A) stated that she had personal issues and could not go in the morning and therefore was going at noon time. The LPN (STAFF A) added that it was just a few days that occur. The LPN (STAFF A) was informed that it was 2 months’ time span. The LPN (STAFF A) then stated that she couldn’t remember exactly how long that occurred. The LPN (STAFF A) stated that she did not communicate the time change of the insulin administration to anyone in the home health agency. On 09/16/22 at 2:0 PM the Director of Nursing confirmed that LPN (STAFF A) had not notified the agency of the change in the insulin administration schedule. Telephone interview was conducted with the Administrator of the Assisted Living Facility were SP#3 resides on 09/20/22 at 12:17 PM. The Administrator confirmed that SP#3 has gotten the insulin injection in the morning for a very long time. The Administrator stated that she was surprised to know the LPN (STAFF A) was going at noon and not in the morning as usual, adding that the LPN (STAFF A) never told her a reason for the change in the time schedule. The Administrator states that LPN (STAFF A) informed her that SP#3 could have the insulin at any time between morning and noon because the patient was only getting it once a day. The provider failed to demonstrate it has maintained an interdisciplinary assessment for SP#1, SP#2 and SP#3 that is the continual involvement of all skilled professional staff involved in a patient's plan of care from the initial assessment through discharge, which should include periodic discussions among the team regarding the patient's health status and recommendations for the plan of care and document the contributions of various health care disciplines (MDs, RNs, and LPNs) and their interactions with each other to meet the patient's needs.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to demonstrate the staff provides the services that are ordered by the physician or allowed practitioner as indicated in the plan of care for 1 out of 3 Sampled Patients (SP). SP#2 Findings include: Clinical record review of SP#2 conducted on 09/15/22 to 09/16/22 revealed the patient was referred to the home health agency for skilled nursing and physical therapy services with prescriptions that read “RN (registered nurse) evaluation and treatment teaching medication injection insulin; wound care at lt (left) leg 3 times / week; and Physical Therapy evaluation and treatment”. Review of the service schedule calendar revealed a Start of Care Assessment scheduled for Registered Nurse with date 09/10/22, an Initial Evaluation for Physical Therapy with date 09/10/22 and the Licensed Practical Nurse (LPN) [Staff C] commenced servicing SP#2 09/11/22 to present. It was inquired from the Director of Nursing (DON) on 09/15/22 at 11:38 am if SP#2 was receiving the wound care nursing service. The DON answered that SP#2 refused for the nurse to provide wound care. Further review of the record omitted case conference(s) that show effective communication and coordination with the patient’s relevant ordering physician and the home health agency staff. A telephone interview was conducted on 09/15/22 at 11:40 AM with the Registered Nurse (RN) [Staff B] that provided the Start of Care Assessment of 09/10/22. The RN (Staff B) stated that the patient informed him that he gets wound care done at wound care center and didn’t allow him to see the wounds on bilateral lower extremities. The RN was inquired if he notified the ordering physician of this (not able to provide wound care because patient refused care) and the nurse stated that he did not call the physician. Interview with the DON on 09/15/22 at 12:37 PM stated that the LPN (Staff C) stated that on her first day of providing care to SP#2, she called the ARNP, to notify that patient refused the wound care and wants to continue only with the wound care being provided at the wound care center 2 times a week. Interview with the DON on 09/15/22 at 1:15 PM. The DON confirmed that she called the wound care center for SP#2 and clarified the wound care service. The DON states that the physician’s nurse informed her that SP#2 goes to the wound care center sometimes unannounced to receive wound care to bilateral lower extremities. The nurse states that patient would benefit from agency nurse to provide the wound care at home and decrease the visits to the wound care center. Telephone interview was conducted on 09/15/22 at 1:54 PM with the advanced registered nurse practitioner (ARNP) that establish the home health treatment orders for SP#2. The ARNP was inquired if notification was done by the home health agency staff that SP#2 refused the wound care upon admission to service. The ARNP stated “no” and added that she is aware of SP#2 going to the wound care center 1 to 2 times a week, and that the home health care order for nurse to provide wound care was done in order to have patient comply with the wound care frequency of 3 times a week.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the Licensed Practical Nurse failed to prepare and record clinical notes for 1 out of 3 Sampled Patients (SP). SP#3 Findings include: Clinical record review conducted on 09/15/22 to 09/16/22 of SP#3 revealed the Plan of Care ordered skilled nursing service daily for 60 days for diabetic care. Further review of the clinical record for date range 06/19/22 to 09/15/22 showed no progress notes from the Licensed Practical Nurse (Staff A) from date(s) 07/31/22 to 09/10/22. Interview conducted with the Director of Nursing on 09/15/22 at 3:40 PM acknowledged findings made by surveyor. The DON added that the nurse needs to submit the nursing notes. On 09/16/22 the DON at 2:06 pm confirmed that the nurse (Staff A) only submitted the nursing notes from 07/31/22 to 08/05/22.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to demonstrate communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care for 2 out of 3 Sampled Patients (SP). SP#1 and SP#3 Findings include: SP#1 record review revealed patient was admitted on 08/12/22 for skilled nurse service to provide wound care daily to sacrum area. The Plan of Care reads “Skilled nurse to notify immediately if any worsening of the skin lesion or increased drainage of the wound is noted. Skilled nurse to take measurement/character of the wound at least once a week and report if signs/symptoms of infections or the other complications are noted”. The Registered Nurse (Staff B) on 08/12/22 completed the initial comprehensive assessment that revealed on [page 12 of 29] “reported date 08/07/22, location: Sacrum, Size (L[length] x W[width] x D[depth]) 2.5 x 2.5 x 0.3, Tunneling and Undermining were left blank; Stage (pressure ulcers only): unstageable; Severity of ulcer (exclude pressure ulcers): skin only, fatty tissue; Odor: none; Surrounding Skin: pink; Edema: none; Appearance of wound bed was left blank; Drainage: small; Color: serosanguineous; Consistency: thin. Further review of the clinical record omitted documentation of the skin tear on the left forearm being reported to the patient’s ordering physician. The Licensed Practical Nurse (Staff A) commenced providing wound care to SP#1 on 08/15/22. The Staff A documented on 08/19/22 sacrum wound measurement (LxWxD) as 2.5 x 2.5 x 0.5; then on 08/26/22 sacrum wound measurement documented as 3 x 2.5 x 0.5 and noted on both notes “drainage small, surrounding tissue pink; no signs or symptoms of infection noted/reported.” The Staff A documents on 08/27/22 “wound care complete healed. MD [medical doctor] notified”. On 08/28/22 the Staff A documents “drainage small, surrounding tissue pink / dark; no signs or symptoms of infection noted”. On 08/29/22 the Staff A documents that “drainage dark, surrounding tissue red, odor foul; skilled nurse report signs or symptoms of infection noted. And contact MD and notified wound infection.” The clinical record for SP#1 omitted documentation that the ordering physician was notified of changes in wound condition as documented on Staff A’s service note date 08/19/22 of the wound depth size had increased from 0.3 to 0.5; then on 08/26/22 the length size increased from 2.5 to 3; then once again on 08/28/22 the Staff A documents on the service note that wound’s surroundings tissue changed from pink to pink/dark. The Staff A failed to notify the ordering physician of all changes in the sacrum wound condition as early as 08/19/22 in order to have prevented the noted infection as documented by the Staff A on 08/29/22 as “drainage dark, surrounding tissue red, odor foul; skilled nurse report signs or symptoms of infection noted. And contact MD and notified wound infection.” Telephone interview was conducted on 09/15/22 at 11:45 AM with Staff B confirmed that patient had skin tears on left arm, but it was mostly redness and dry. The Staff B confirmed that the skin tears were not reported to the physician because they didn’t require wound care. On 09/15/22 the Staff B provided a picture taken at admission on 08/15/22 of the left arm skin tears that were observed to be 5 open areas with pink to beefy red appearance on the inner aspect of forearm [4 open areas] and inner aspect of arm [the humerus area, 1 open area]; and a picture of the sacrum that was observed on the picture the wound bed was covered with yellow slough tissue. Telephone interview was conducted on 09/15/22 at 2:01 PM with Staff A and stated that she told the ALF [assisted living facility] Administrator few days before about the sacral wound status, and she re-laid it to the ARNP [advanced registered nurse practitioner] who ordered the home health service for wound care. The Staff A stated that the ALF Administrator then informed her that the ARNP would visit patient on 09/01/22 to evaluate the wound. The Staff A confirmed that she did not speak with the ARNP directly, it was first with the ALF Administrator. The Staff A states that on 09/01/22, she notified the ARNP that the sacral wound just got worse one day to the next, all surrounding area got reddened and the ARNP ordered for the patient to be taken to the hospital for evaluation of possible wound infection. Clinical record review was conducted from 09/15/22 to 09/16/22 of SP#3 revealed the Plan of Care (POC) reads for skilled nurse to provide “Skilled Nurse to prepare/administer insulin subcutaneous injection daily”. Review of the clinical record for date range 06/19/22 to 08/27/22 of the skilled nurse service notes revealed the patient was receiving insulin injection in the early morning (7-8am), then as of 06/26/22 to 08/27/22, the nurse documents providing the insulin injection at noon (12-1pm), then once again as of 08/28/22 to present the nurse documents providing the insulin injection in the early morning (7-8am). Further review of the record omitted case conference notification that the ordering physician was notified of the change in time for the insulin administration. A telephone interview was conducted with the Licensed Practical Nurse (LPN) [Staff A] that provides nursing care to SP#3 on 09/15/22 at 3:43 PM. As per LPN (STAFF A), she is providing insulin to SP#3 in the morning. The LPN (STAFF A) stated that she had personal issues and could not go in the morning and therefore was going at noon time. The LPN (STAFF A) added that it was just a few days that occur. The LPN (STAFF A) was informed that it was 2 months’ time span. The LPN (STAFF A) then stated that she couldn’t remember exactly how long that occurred. The LPN (STAFF A) stated that she did not communicate the time change of the insulin administration to anyone in the home health agency. On 09/16/22 at 2:0 PM the Director of Nursing confirmed that LPN (STAFF A) had not notified the agency of the change in the insulin administration schedule. Telephone interview was conducted with the Administrator of the Assisted Living Facility were SP#3 resides on 09/20/22 at 12:17 PM. The Administrator confirmed that SP#3 has gotten the insulin injection in the morning for a very long time. The Administrator stated that she was surprised to know the LPN (STAFF A) was going at noon and not in the morning as usual, adding that the LPN (STAFF A) never told her a reason for the change in the time schedule. The Administrator states that LPN (STAFF A) informed her that SP#3 could have the insulin at any time between morning and noon because the patient was only getting it once a day.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to demonstrate the clinical manager assure the development, implementation, and updates of the individualized plan of care for 3 out of 3 Sampled Patient (SP). SP#1, SP#2 and SP#3 Findings include: Clinical record review was conducted of SP#1, SP#2 and SP#3 on 09/15/22 to 09/16/22. SP#1 record review revealed patient was admitted on 08/12/22 for skilled nurse service to provide wound care daily to sacrum area. The Registered Nurse (Staff B) on 08/12/22 completed the initial comprehensive assessment that revealed “pressure ulcer on sacrum / skin tear on left forearm” [page 3 of 29]. Further review of the clinical record omitted documentation of the skin tear on the left forearm being reported to the patient’s ordering physician. The Plan of Care reads “Skilled nurse to notify immediately if any worsening of the skin lesion or increased drainage of the wound is noted. Skilled nurse to take measurement/character of the wound at least once a week and report if signs/symptoms of infections or the other complications are noted”. The Registered Nurse (Staff B) on 08/12/22 completed the initial comprehensive assessment that revealed on [page 12 of 29] “reported date 08/07/22, location: Sacrum, Size (L[length] x W[width] x D[depth]) 2.5 x 2.5 x 0.3, Tunneling and Undermining were left blank; Stage (pressure ulcers only): unstageable; Severity of ulcer (exclude pressure ulcers): skin only, fatty tissue; Odor: none; Surrounding Skin: pink; Edema: none; Appearance of wound bed was left blank; Drainage: small; Color: serosanguineous; Consistency: thin. Further review of the clinical record omitted documentation of the skin tear on the left forearm being reported to the patient’s ordering physician. The Licensed Practical Nurse (Staff A) commenced providing wound care to SP#1 on 08/15/22. The Staff A documented on 08/19/22 sacrum wound measurement (LxWxD) as 2.5 x 2.5 x 0.5; then on 08/26/22 sacrum wound measurement documented as 3 x 2.5 x 0.5 and noted on both notes “drainage small, surrounding tissue pink; no signs or symptoms of infection noted/reported.” The Staff A documents on 08/27/22 “wound care complete healed. MD [medical doctor] notified”. On 08/28/22 the Staff A documents “drainage small, surrounding tissue pink / dark; no signs or symptoms of infection noted”. On 08/29/22 the Staff A documents that “drainage dark, surrounding tissue red, odor foul; skilled nurse report signs or symptoms of infection noted. And contact MD and notified wound infection.” The clinical record for SP#1 omitted documentation that the ordering physician was notified of changes in wound condition as documented on Staff A’s service note date 08/19/22 of the wound depth size had increased from 0.3 to 0.5; then on 08/26/22 the length size increased from 2.5 to 3; then once again on 08/28/22 the Staff A documents on the service note that wound’s surroundings tissue changed from pink to pink/dark. The Staff A failed to notify the ordering physician of all changes in the sacrum wound condition as early as 08/19/22 in order to have prevented the noted infection as documented by the Staff A on 08/29/22 as “drainage dark, surrounding tissue red, odor foul; skilled nurse report signs or symptoms of infection noted. And contact MD and notified wound infection.” Telephone interview was conducted on 09/15/22 at 11:45 AM with Staff B confirmed that patient had skin tears on left arm, but it was mostly redness and dry. The Staff B confirmed that the skin tears were not reported to the physician because they didn’t require wound care. On 09/15/22 the Staff B provided a picture taken at admission on 08/15/22 of the left arm skin tears that were observed to be 5 open areas with pink to beefy red appearance on the inner aspect of forearm [4 open areas] and inner aspect of arm [the humerus area, 1 open area]; and a picture of the sacrum that was observed on the picture the wound bed was covered with yellow slough tissue. Telephone interview was conducted on 09/15/22 at 2:01 PM with Staff A and stated that she told the ALF [assisted living facility] Administrator few days before about the sacral wound status, and she re-laid it to the ARNP [advanced registered nurse practitioner] who ordered the home health service for wound care. The Staff A stated that the ALF Administrator then informed her that the ARNP would visit patient on 09/01/22 to evaluate the wound. The Staff A confirmed that she did not speak with the ARNP directly, it was first with the ALF Administrator. The Staff A states that on 09/01/22, she notified the ARNP that the sacral wound just got worse one day to the next, all surrounding area got reddened and the ARNP ordered for the patient to be taken to the hospital for evaluation of possible wound infection. SP#2 record review revealed the patient was referred to the home health agency for skilled nursing and physical therapy services with prescriptions that read “RN (registered nurse) evaluation and treatment teaching medication injection insulin; wound care at lt (left) leg 3 times / week; and Physical Therapy evaluation and treatment”. Review of the service schedule calendar revealed a Start of Care Assessment scheduled for Registered Nurse with date 09/10/22, an Initial Evaluation for Physical Therapy with date 09/10/22 and the Licensed Practical Nurse (LPN) [Staff C] commenced servicing SP#2 09/11/22 to present. It was inquired from the Director of Nursing (DON) on 09/15/22 at 11:38 am if SP#2 was receiving the wound care nursing service. The DON answered that SP#2 refused for the nurse to provide wound care. Further review of the record omitted case conference(s) that show effective communication and coordination with the patient’s relevant ordering physician and the home health agency staff. A telephone interview was conducted on 09/15/22 at 11:40 AM with the Registered Nurse (RN) [Staff B] that provided the Start of Care Assessment of 09/10/22. The RN (Staff B) stated that the patient informed him that he gets wound care done at wound care center and didn’t allow him to see the wounds on bilateral lower extremities. The RN was inquired if he notified the ordering physician of this (not able to provide wound care because patient refused care) and the nurse stated that he did not call the physician. Interview with the DON on 09/15/22 at 12:37 PM stated that the LPN (Staff C) stated that on her first day of providing care to SP#2, she called the ARNP, to notify that patient refused the wound care and wants to continue only with the wound care being provided at the wound care center 2 times a week. Interview with the DON on 09/15/22 at 1:15 PM. The DON confirmed that she called the wound care center for SP#2 and clarified the wound care service. The DON states that the physician’s nurse informed her that SP#2 goes to the wound care center sometimes unannounced to receive wound care to bilateral lower extremities. The nurse states that patient would benefit from agency nurse to provide the wound care at home and decrease the visits to the wound care center. Telephone interview was conducted on 09/15/22 at 1:54 PM with the advanced registered nurse practitioner (ARNP) that establish the home health treatment orders for SP#2. The ARNP was inquired if notification was done by the home health agency staff that SP#2 refused the wound care upon admission to service. The ARNP stated “no” and added that she is aware of SP#2 going to the wound care center 1 to 2 times a week, and that the home health care order for nurse to provide wound care was done in order to have patient comply with the wound care frequency of 3 times a week. Clinical record review was conducted from 09/15/22 to 09/16/22 of SP#3 revealed the Plan of Care (POC) reads for skilled nurse to provide “Skilled Nurse to prepare/administer insulin subcutaneous injection daily”. Review of the clinical record for date range 06/19/22 to 08/27/22 of the skilled nurse service notes revealed the patient was receiving insulin injection in the early morning (7-8am), then as of 06/26/22 to 08/27/22, the nurse documents providing the insulin injection at noon (12-1pm), then once again as of 08/28/22 to present the nurse documents providing the insulin injection in the early morning (7-8am). Further review of the record omitted case conference notification that the ordering physician was notified of the change in time for the insulin administration. A telephone interview was conducted with the Licensed Practical Nurse (LPN) [Staff A] that provides nursing care to SP#3 on 09/15/22 at 3:43 PM. As per LPN (STAFF A), she is providing insulin to SP#3 in the morning. The LPN (STAFF A) stated that she had personal issues and could not go in the morning and therefore was going at noon time. The LPN (STAFF A) added that it was just a few days that occur. The LPN (STAFF A) was informed that it was 2 months’ time span. The LPN (STAFF A) then stated that she couldn’t remember exactly how long that occurred. The LPN (STAFF A) stated that she did not communicate the time change of the insulin administration to anyone in the home health agency. On 09/16/22 at 2:0 PM the Director of Nursing confirmed that LPN (STAFF A) had not notified the agency of the change in the insulin administration schedule. Telephone interview was conducted with the Administrator of the Assisted Living Facility were SP#3 resides on 09/20/22 at 12:17 PM. The Administrator confirmed that SP#3 has gotten the insulin injection in the morning for a very long time. The Administrator stated that she was surprised to know the LPN (STAFF A) was going at noon and not in the morning as usual, adding that the LPN (STAFF A) never told her a reason for the change in the time schedule. The Administrator states that LPN (STAFF A) informed her that SP#3 could have the insulin at any time between morning and noon because the patient was only getting it once a day. The provider failed to demonstrate it has maintained an interdisciplinary assessment for SP#1, SP#2 and SP#3 that is the continual involvement of all skilled professional staff involved in a patient's plan of care from the initial assessment through discharge, which should include periodic discussions among the team regarding the patient's health status and recommendations for the plan of care and document the contributions of various health care disciplines (MDs, RNs, and LPNs) and their interactions with each other to meet the patient's needs.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency staff failed to comply in accordance with current clinical practice guidelines and accepted professional standards of practice for 2 out of 3 Sampled Patients (SP). SP#1 and SP#2 Findings include: Clinical record review was conducted of SP#1 and SP#2 on 09/15/22 to 09/16/22. SP#1 record review revealed patient was admitted on 08/12/22 for skilled nurse service to provide wound care daily to sacrum area. The Registered Nurse (Staff B) on 08/12/22 completed the initial comprehensive assessment that revealed “pressure ulcer on sacrum / skin tear on left forearm” [page 3 of 29]. Further review of the clinical record omitted documentation of the skin tear on the left forearm being reported to the patient’s ordering physician. Telephone interview conducted on 09/15/22 at 11:45 AM with Staff B confirmed that patient had skin tears on left arm, but it was mostly redness and dry. The Staff B confirmed that the skin tears were not reported to the physician because they didn’t require wound care. On 09/15/22 the Staff B provided a picture of the left arm skin tears that were observed to be 5 open areas with pink to beefy red appearance on the inner aspect of forearm [4 open areas] and inner aspect of arm [the humerus area, 1 open area]. SP#2 record review revealed the patient was referred to the home health agency for skilled nursing and physical therapy services with prescriptions that read “RN (registered nurse) evaluation and treatment teaching medication injection insulin; wound care at lt (left) leg 3 times / week; and Physical Therapy evaluation and treatment”. Review of the service schedule calendar revealed a Start of Care Assessment scheduled for Registered Nurse with date 09/10/22, an Initial Evaluation for Physical Therapy with date 09/10/22 and the Licensed Practical Nurse (LPN) [Staff C] commenced servicing SP#2 09/11/22 to present. It was inquired from the Director of Nursing (DON) on 09/15/22 at 11:38 am if SP#2 was receiving the wound care nursing service. The DON answered that SP#2 refused for the nurse to provide wound care. Further review of the record omitted case conference(s) that show effective communication and coordination with the patient’s relevant ordering physician and the home health agency staff. A telephone interview was conducted on 09/15/22 at 11:40 AM with the Registered Nurse (RN) [Staff B] that provided the Start of Care Assessment of 09/10/22. The RN (Staff B) stated that the patient informed him that he gets wound care done at wound care center and didn’t allow him to see the wounds on bilateral lower extremities. The RN was inquired if he notified the ordering physician of this (not able to provide wound care because patient refused care) and the nurse stated that he did not call the physician.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to demonstrate complete documentation of all interventions, including treatments, and responses to those interventions for 1 out of 3 Sampled Patients (SP). SP#1 Findings include: SP#1 record review conducted on 09/15/22 to 09/16/22 revealed patient was admitted on 08/12/22 for skilled nurse service to provide wound care daily to sacrum area. The Registered Nurse (Staff B) on 08/12/22 completed the initial comprehensive assessment that revealed “pressure ulcer on sacrum / skin tear on left forearm” [page 3 of 29]. Further review of the clinical record omitted documentation of the skin tear on the left forearm being reported to the patient’s ordering physician. The Plan of Care reads “Skilled nurse to notify immediately if any worsening of the skin lesion or increased drainage of the wound is noted. Skilled nurse to take measurement/character of the wound at least once a week and report if signs/symptoms of infections or the other complications are noted”. The Registered Nurse (Staff B) on 08/12/22 completed the initial comprehensive assessment that revealed on [page 12 of 29] “reported date 08/07/22, location: Sacrum, Size (L[length] x W[width] x D[depth]) 2.5 x 2.5 x 0.3, Tunneling and Undermining were left blank; Stage (pressure ulcers only): unstageable; Severity of ulcer (exclude pressure ulcers): skin only, fatty tissue; Odor: none; Surrounding Skin: pink; Edema: none; Appearance of wound bed was left blank; Drainage: small; Color: serosanguineous; Consistency: thin. Further review of the clinical record omitted documentation of the skin tear on the left forearm being reported to the patient’s ordering physician. The Licensed Practical Nurse (Staff A) commenced providing wound care to SP#1 on 08/15/22. The Staff A documented on 08/19/22 sacrum wound measurement (LxWxD) as 2.5 x 2.5 x 0.5; then on 08/26/22 sacrum wound measurement documented as 3 x 2.5 x 0.5 and noted on both notes “drainage small, surrounding tissue pink; no signs or symptoms of infection noted/reported.” The Staff A documents on 08/27/22 “wound care complete healed. MD [medical doctor] notified”. On 08/28/22 the Staff A documents “drainage small, surrounding tissue pink / dark; no signs or symptoms of infection noted”. On 08/29/22 the Staff A documents that “drainage dark, surrounding tissue red, odor foul; skilled nurse report signs or symptoms of infection noted. And contact MD and notified wound infection.” The Staff A failed to document the ordering physician was notified of all changes in the sacrum wound condition, and further review of the service notes revealed the Staff A failed to document the SP#2’s response to the wound care [at the time of each wound care treatment]. Telephone interview was conducted on 09/15/22 at 11:45 AM with Staff B confirmed that patient had skin tears on left arm, but it was mostly redness and dry. The Staff B confirmed that the skin tears were not reported to the physician because they didn’t require wound care. On 09/15/22 the Staff B provided a picture taken at admission on 08/15/22 of the left arm skin tears that were observed to be 5 open areas with pink to beefy red appearance on the inner aspect of forearm [4 open areas] and inner aspect of arm [the humerus area, 1 open area]; and a picture of the sacrum that was observed on the picture the wound bed was covered with yellow slough tissue. Telephone interview was conducted on 09/15/22 at 2:01 PM with Staff A and stated that she told the ALF [assisted living facility] Administrator few days before about the sacral wound status, and she re-laid it to the ARNP [advanced registered nurse practitioner] who ordered the home health service for wound care. The Staff A stated that the ALF Administrator then informed her that the ARNP would visit patient on 09/01/22 to evaluate the wound. The Staff A confirmed that she did not speak with the ARNP directly, it was first with the ALF Administrator. The Staff A states that on 09/01/22, she notified the ARNP that the sacral wound just got worse one day to the next, all surrounding area got reddened and the ARNP ordered for the patient to be taken to the hospital for evaluation of possible wound infection. On 09/15/22 at 3:23 PM a telephone interview was conducted with the Staff A. The Staff was read the notation of “wound healed, MD [medical doctor] notified” noted on service note dated 08/27/22 and the Staff A stated it must have been by error written, that was incorrect.

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 home health agency failed to demonstrate all entries in the clinical record are appropriately authenticated, which includes a primary author who has reviewed and approved the entry for 1 out 3 Sampled Patients (SP). SP#1 Findings include: SP#1 record review conducted on 09/15/22 to 09/16/22 revealed patient was admitted on 08/12/22 for skilled nurse service to provide wound care daily to sacrum area. The Registered Nurse (Staff B) on 08/12/22 completed the initial comprehensive assessment and the visits for scheduled dates 08/13/22 and 08/14/22. Further review of the clinical record revealed the Licensed Practical Nurse (Staff A) commenced servicing the SP#1 as of 08/15/22 and last serviced the SP#1 on 09/01/22. Telephone interview was conducted on 09/15/22 at 11:47 AM with Staff B, who stated that he only provided admission visit. The Staff A was informed that service notes for 08/13 and 08/14 have his name on them. The Staff A again stated he did not provide those visits; adding that he only did the admission visit because the SP#1 is in [city location name] and it’s too far for him to cover. Telephone interview was conducted on 09/15/22 at 2:08 pm with Staff A, who stated that SP#1 was admitted to service on 08/12/22 and she started to service SP#1 on 08/15/22. On 09/15/22 the Director of Nursing provided a certified visit report for Staff A for date range 06/01/22 to 09/15/22 that revealed the SP#1 was listed for service dates 08/13/22 and 08/14/22 and not paid. On 09/16/22 the Director of Nursing provided a certified visit report for Staff B for date range 08/01/22 to 09/16/22 that revealed the SP#1 “sign up” visit was paid and noted as “received 08/15/22”. Further review of the certified visit report revealed the Staff B was not paid for service dates 08/13/22 and 08/14/22.