A Better Colorado Home Health Care Agency LLC

“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 the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 484.55, COMPREHENSIVE ASSESSMENT OF PATIENTS was out of compliance. The collective deficient practice illustrated systemic process failures that had the potential to affect all patients cared for by the agency. A total of 7 clinical records were reviewed for compliance with the Condition and Standards for Comprehensive Assessment of Patients. Record review revealed a pattern of failures in regard to the completion of comprehensive assessments. Specifically, the agency failed to ensure each patient received a comprehensive assessment within 48 hours of receiving a referral and within the last 5 days of a 60 certification period as required by regulation. The following standard level deficiencies were also cited. G514 - Standard: Initial comprehensive assessment - The agency failed to ensure each patient received a comprehensive assessment within 48 hours of referral, within 48 hours of the patients return home, or on the physician or allowed practitioner ordered star of care date. G546 - Standard: Update of the comprehensive assessment - The agency failed to ensure each patient received an updated comprehensive assessment the last five days of every 60 days beginning with the start of care date.”

“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 the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 484.60, CARE PLANNING, COORDINATION, QUALITY OF CARE was out of compliance. The collective deficient practice illustrated a systemic process failure that had the potential to affect all patients cared for by the agency. A total of 7 clinical records were reviewed for compliance with the Condition and Standards for Care Planning, Coordination and Quality of Care. Record reviews revealed a pattern of failure in regard to the establishment and implementation of patient’s plans of care. Specifically the agency failed to ensure all patients had an individualized written plan of care including any revisions or additions; to ensure services and treatments were provided in conformance with physician orders; and to ensure physicians reviewed and revised the plans of care at least once every 60 days. A. Based on interview and record review, the agency failed to establish a plan of care (POC) which specified the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment for 1 of 5 active patients reviewed (Patient #1). Finding include: AGENCY POLICY According to an undated agency policy titled, Plan of Care Requirements, (read in pertinent parts): “Each patient must receive Home Health services that are written in an individualized plan of care, including any revisions or additions, that identifies the care, and services necessary to meet the patient-specific needs, including identification of the responsible discipline(s), patient-specific measurable outcomes and goals that the agency anticipates will occur, as a result of implementing and coordinating the plan of care, as identified in the comprehensive assessment, which is established, periodically reviewed, and signed by a Doctor of Medicine, osteopathy, or podiatry, acting within the scope of his/her stated license, certification, or registration. 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.” 1. During an interview on 6/28/24 at 11:14 a.m., the administrator stated POCs were developed by the clinician who completed the start of care or recertification comprehensive assessment, which typically was a registered nurse (RN) or a physical therapist (PT). The administrator stated the agency expected the RN/PT to complete their documentation on the comprehensive assessment within 72 hours. The administrator stated if the RN/PT took longer than 72 hours to complete the paperwork a member of the agency management staff would reach out to the clinician to see why the paperwork was not completed. The administrator stated she would review the comprehensive documentation to assess if it was accurate and send it back to the RN/PT to correct if she noted errors. After the RN/PT completed the comprehensive assessment he/she could use the information from the assessment to develop a POC for the patient. The administrator stated she expected the RN/PT to review the POC and ensure the POC was accurate. During continued interview the administrator stated the agency was without a director of nursing (DON) from January 2024 until the alternate administrator was appointed as the alternate administrator and DON on 5/22/24. The administrator stated due to the agency’s lack of staff “things were slipping under the rug.” During an interview on 7/2/24 at 8:55 a.m., the alternate administrator stated agency RN’s or PT’s completed the comprehensive assessment for patients. The alternate administrator stated the agency encouraged clinicians to complete the paperwork for the reassessment and corresponding next certification period POC to be completed within 24 to 48 hours of the reassessment visit date. The alternate administrator stated prior to May of 2024, the administrator tracked on a whiteboard, when a patient was due for a reassessment and the agency’s EMR also tracked when a patient was due for a reassessment. The alternate administrator stated since the administrator went out on medical leave in early May 2024, it was a team effort to track when patients were due for reassessments. The alternate administrator stated she and the non-skilled agency manager were attempting to track when a patient was due for a reassessment, but acknowledged the agency had fallen behind on scheduling and ensuring reassessments were completed in the last five days of a 60 day certification period. Additionally, the alternate administrator stated no one at the agency was ensuring clinician’s completed a patient’s reassessment and the corresponding paperwork including generating the new POC as scheduled. During an interview on 6/27/24 at 12:52 p.m., the non-medical alternate agency manager stated typically the administrator tracked when comprehensive reassessments were due, however, since the administrator went out on medical leave in early May of 2024, the non-medical alternate agency manager was attempting to keep track when patient’s comprehensive reassessments were due. The non-medical alternate agency manager stated the agency was behind on completing comprehensive reassessments as the administrator and licensed practical nurse (LPN) #5 were both out on medical leave. The non-medical alternate agency manager stated neither the administrator or LPN #5 completed comprehensive assessments prior to going out on leave, but in their absence, the agency was short staffed particularly for skilled nursing (SN) needs. During continued interview, the non-skilled alternate agency manager stated she also was responsible for faxing supplemental orders and POCs to patient’s physicians for review and signature. The non-skilled alternate agency manager stated the administrator informed her when a POC or a supplemental order was ready to be faxed to the patient’s physician. 2. The clinical record for Patient #1 was reviewed on 6/24/24. The POC for the certification period dated 3/2/24 to 4/30/24 (the last documented POC in Patient #1’s record), signed by Patient #1’s physician on 6/10/24, revealed a start of care date of 11/8/22; diagnoses included type 2 diabetes mellitus, hypertension, hyperlipidemia, anxiety, acute kidney failure, and dyspnea. POC orders included SN visits three times a day for assessment and evaluation, medication management and weekly medication setup. a) The agency failed to ensure a plan of care was established for all services provided to Patient #1 from 5/1/24 to 6/24/24. Review of the clinical record for Patient #1 revealed a new 60 day certification period started on 5/1/24 and the 60 day certification period was from 5/1/24 through 6/29/24. Further review of the clinical record revealed the five day reassessment window was from 4/26/24 to 4/30/24, however, the agency failed to have a RN complete an assessment for the 5/1/24 to 6/29/24 certification period. Cross Reference G546 Review of the clinical record for Patient #1 revealed a new 60 day certification period started on 6/30/24 and the 60 day certification period was from 6/30/24 through 8/28/24. Further review of the clinical record revealed the five day reassessment window was from 6/25/24 to 6/29/24, however, RN #3 performed the reassessment on 6/24/24, one day earlier than the five day reassessment window. Cross Reference G546 Review of Patient #1’s clinical record revealed no POC after the end of the last certification on 4/30/24. Furthermore there was no documentation of any verbal orders, or request orders to continue SN services after 4/30/24. Review of SN notes and missed visit documentation from 5/1/24 to 6/24/24 showed Patient #1 received SN services three times a day except for 5/5/24 and 5/7/24 for all three visits and 5/6/24 for the third treatment of the day due to missed visits documented as Patient #1 refused each of the visits. During an interview on 6/26/24 at 3:50 p.m., RN #3 acknowledged she completed a comprehensive reassessment for Patient #1 on Monday 6/24/24 per the direction of the agency’s non-medical alternate manager, Employee #7. RN #3 stated she had just recently learned how to generate a POC from the comprehensive assessment and she had not had time to complete the paperwork to generate the POC that corresponded with the 6/24/24 comprehensive reassessment she completed with Patient #1. RN #3 stated she did not know why a comprehensive reassessment or POC was not completed for the certification period 5/1/24 to 6/29/24 for Patient #1. During an interview on 7/2/24 at 2:31 p.m., the administrator stated she thought the 6/24/24 comprehensive assessment for Patient #1 was completed a day earlier for the 6/30/23 to 8/28/24 certification period, but she was not positive as she had been out and the alternate administrator and non-medical alternate agency manager were responsible for tracking and reminding clinicians when a patient was due for a comprehensive assessment. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions. During an interview on 7/2/24 at 9:15 a.m., the alternate administrator stated she was not familiar with Patient #1’s case. The alternate administrator reviewed Patient #1’s clinical record and stated Patient #1 had a comprehensive assessment completed on 3/1/24 by RN #3 and Patient #1’s next comprehensive assessment was completed on 6/24/24 by RN #3, 115 days later. The alternate administrator acknowledged Patient #1 was missing a comprehensive assessment that should have been completed between 4/26/24 to 4/30/24 and failed to have a POC for the certification period for 5/1/24 to 6/29/24. The alternate administrator also acknowledged Patient #1 did not have continuation of care orders after 4/30/24. The alternate administrator stated she did not know why Patient #1 was missing the comprehensive assessment, POC and/or continuation orders for care provided to Patient #1 from 5/1/24 through 6/24/24. The alternate administrator stated the agency’s EMR was missing documentation so it was possible the reassessment and POC was deleted. B. The following standard level deficiencies were also cited. G574- Standard: Plan of care must include the following- The agency failed to ensure each patient had a complete and accurate plan of care. G580- Standard: Only as ordered by the physician - The agency failed to ensure services and treatments were administered by agency staff only as ordered by a physician. G588- Standard: Reviewed by physician every 60 days- The agency failed to ensure each patient’s total plan of care was reviewed by the physician at least every 60 days.”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 484.105, ORGANIZATION AND ADMINISTRATION OF SERVICES was out of compliance. The collective deficient practice illustrated a systemic process failure that had the potential to affect all patients cared for by the agency. A total of 7 clinical records were reviewed for compliance with the Condition and Standards of Organization and Administration of Services. Record review revealed a pattern of failures in regard to the completion of comprehensive assessments. Record review revealed the agency’s administration failed to ensure the agency organized, managed and administered resources to attain and maintain the highest practicable functional capacity involved in operations of care planning, coordination and quality of care for patients. These failures had the potential to affect all patients served by the home health agency. A. Record review and interview revealed the agency’s governing body consisted of the owner, administrator, alternate administrator (also the director of nursing, DON), and non-skilled alternate agency manager. The agency had lacked effective leadership for some time. The agency had been without a clinical manager/DON from January 2024 to 5/22/24. The agency owner had been out of the country and not involved in the leadership of the agency since at least May of 2023. The agency was without an alternate administrator from 1/1/24 to 5/22/24, as well as the current alternate administrator not having been trained by the administrator. The administrator had been on medical leave since 5/7/24. This lack of leadership and training for alternate leadership led to multiple systemic failures across the agency. 1. During an interview on 6/28/24 at approximately 11:30 a.m., the administrator stated the agency did not have a clinical manager/DON for the last 5 months. The administrator stated the current DON accepted the position on 5/22/24 but did not have a clinical manager/DON since January of 2024. 2. During an interview on 6/28/24 at approximately 11:30 a.m., the administrator stated the agency owner had been out of the country since approximately May of 2023. The administrator went on to state the governing body still met remotely via web meeting applications but issues did not always get resolved. 3. During an interview on 6/28/24 at approximately 11:30 a.m., the administrator stated the agency did not have an alternate administrator between January of 2024 and 5/22/24. The administrator stated she ha not had time to train the alternate administrator in all of the details of the operations of the agency. During an interview on 6/27/24 at 2:52 p.m., the alternate administrator/DON stated the administrator had not trained her, since the administrator had been out of the office on medical leave since 5/7/24, and the alternate administrator/DON accepted the position on 5/22/24. 4.During an interview on 6/28/24 at 11:30 a.m., the administrator stated she has been put in a difficult situation of working in an office without help. The administrator stated she was without assistance in her tasks until she went wont medical leave on 5/7/24. The administrator stated things at the agency were slipping under the rug. The administrator continued to state she was the only one doing chart audits and reviewing things and these things have not been happening since she has been on her medical leave. During an interview 7/2/24 at 1:59 p.m., the administrator stated since her medical leave on 5/7/24 things at the agency have been slipping and items have been missed. The administrator stated she had not had a chance to train the alternate administrator and this was one of the reasons things were getting missed at the agency. B. The lack of leadership led to the following condition and standard level deficiencies being cited. 1. The administrator failed to ensure each beneficiary who received Medicare, a Medicare advantage plan, and/or Medicaid had Outcome and Assessment Information Set (OASIS) was electronically encoded and transmitted to the CMS in 5 of 5 active patient records reviewed. During an interview on 7/2/24 at 1:58 p.m., the administrator acknowledged she was the only employee trained on how to submit OASIS data. The administrator stated she was taught by the previous administrator, she only had to transmit data for patients who had traditional Medicare insurance plans. The administrator stated she was unaware regulation required her to transmit data for all beneficiaries of Medicare and Medicaid. The administrator acknowledged the last transmission of OASIS data for the agency was on 4/18/24.The administrator stated she planned to train the alternate administrator on how to transmit OASIS data, but had been unable to train the alternate administrator prior to going out on medical leave in early May 2024. Cross Reference G372 (Standard level) 2. The administrator failed to document the resolution of a patient complaint for 1 of 1 patient records reviewed who called the agency with a complaint. During an interview on 7/2/24 at 2:19 p.m., the administrator stated, although she had been on medical leave from early May 2024, she did come into the office on 6/10/24 and called Patient #7. The administrator stated Patient #7 appeared confused during her conversation with the administrator as Patient #7 first stated licensed practical nurse (LPN) #11 never came to see her on 6/9/24 and then stated she did. The administrator stated Patient #7 expressed concerns about not knowing her options on how to get her leaking colostomy bag fixed on 6/8/24. The administrator stated Patient #7 informed the administrator she was not told by the assisted living residence (ALR) employee the agency had offered to send LPN #11 to see her on 6/9/24. Additionally, the administrator stated the ALR employee attempted to call agency nurses directly instead of communicating to the agency via the on-call number which led to miscommunication. The administrator stated she educated Patient #7 to call the office, not agency nurses directly if she had any future issues to try to prevent any further miscommunication, and Patient #7 appeared to be satisfied with this resolution. The administrator acknowledged she failed to document her conversation with Patient #7 either in Patient #7’s communication log or in the complaint log. The administrator stated she was in and out of the office as she was on medical leave and was too “lackadaisical” at times with the timeliness of her documentation. The administrator stated she would work on improving her timeliness of documentation and education to staff on what information should be included in the complaint log. Cross Reference G484 3. The administrator failed to ensure each patient received a comprehensive assessment within 48 hours of receiving a referral and within the last 5 days of a 60 certification period as required by set forth in Code of Regulations 484.55. Cross reference G510 (Condition) a) The administrator failed to ensure an initial assessment was provided within 48 hours of referral by a physician for 2 of 7 patients reviewed. During an interview on 6/26/24 at 11:47 a.m., the alternate administrator reviewed Patient #2’s record and stated Patient #2’s record failed to contain a delayed start of care order or communication note explaining why Patient #2’s start of care was delayed. The alternate administrator stated she did not know why Patient #2’s start of care was delayed. During an interview on 6/26/24 at 12:54 p.m., the alternate administrator stated she spoke with the administrator, who was on medical leave from the agency, and the administrator could not recall why Patient #2’s start of care was delayed. During an interview on 6/26/24 at 11:58 a.m., the alternate administrator stated she did not know why Patient #7’s start of care assessment was completed 10 days after Patient #7 discharged from a skilled nursing facility (SNF) to an ALR. The alternate administrator reviewed Patient #7’s record and acknowledged Patient #7’s record failed to contain a delayed start of care order or a communication note explaining why Patient #7’s start of care was delayed. During an interview on 6/26/24 at 12:43 p.m., the alternate administrator stated the administrator informed the alternate administrator, Patient #7’s start of care was delayed as Patient #7’s move into her ALR was delayed. The alternate administrator stated Patient #7 declined her physicial therapy (PT) start of care assessment until she was moved into her new ALR. The alternate administrator stated the administrator informed the alternate administrator, the administrator had spoken to Patient #7’s primary care physician (PCP) many times regarding Patient #7’s delayed start of care; and the administrator had documented these conversations in the administrator’s personal documentation. The administrator informed the alternate administrator she failed to document these conversations in Patient #7’s communication notes and had failed to document a delayed start of care order for Patient #7. Cross Reference G514 b) The administrator failed to ensure comprehensive assessments were performed in the last five days of a 60 day certification period for 2 of 4 active patient records reviewed who required a recertification comprehensive assessments. During an interview on 7/2/24 at 10:43 a.m., the alternate administrator stated she reviewed Patient #5’s record and acknowledged the certification periods in the record were not accurately documented and were not accurately documented on the comprehensive assessments completed for Patient #5. The alternate administrator stated it would take her awhile to figure out how to correct the inaccurate dates documented in Patient #5’s clinical record for certification periods and comprehensive assessments. During continued interview, the alternate administrator stated to the best of her knowledge, back in 2022 a registered nurse (RN) started Patient #5’s care and then a PT completed a new certification period and the inaccurate dating of certification periods particularly on comprehensive assessments began during this time. The alternate administrator stated she believed the accurate certification periods for Patient #5 were 2/1/24 to 3/31/24, 4/1/24 to 5/30/24 and 5/31/24 to 7/29/24. The alternate administrator stated the recertification comprehensive assessment completed on 2/8/24 was completed late for the 2/1/24 to 3/31/24 certification period; the electronic medical record (EMR) failed to show a recertification comprehensive assessment for the 4/1/24 to 5/30/24 certification period; and the 6/10/24 recertification comprehensive assessment was the reassessment completed late for the 5/31/24 to 7/28/24 certification period. During an interview on 6/27/24 at 9:49 a.m., the alternate administrator stated Patient #5 had a recertification comprehensive assessment completed for the certification period 4/1/24 to 5/30/24, but acknowledged this recertification comprehensive assessment was not documented in the agency’s EMR. The alternate administrator stated any clinician with access to the EMR could delete items from the EMR so it was possible a disgruntled employee had deleted Patient #5’s recertification comprehensive assessment for the certification period dated 4/1/24 to 5/30/24. During an interview on 7/2/24 at 2:31 p.m., the administrator stated she thought the 6/24/24 comprehensive assessment for Patient #1 was completed a day earlier for the 6/30/23 to 8/28/24 certification period, but she was not positive as she had been out and the alternate administrator and non-medical alternate agency manager were responsible for tracking and reminding clinicians when a patient was due for a comprehensive assessment. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions regarding late comprehensive assessments. During an interview on 7/2/24 at 9:15 a.m., the alternate administrator stated she was not familiar with Patient #1’s case. The alternate administrator reviewed Patient #1’s clinical record and stated Patient #1 had a comprehensive assessment completed on 3/1/24 by RN #3 and Patient #1’s next comprehensive assessment was completed on 6/24/24 by RN #3, 115 days later. The alternate administrator acknowledged Patient #1 was missing a comprehensive assessment that should have been completed between 4/26/24 to 4/30/24 and failed to have a POC for the certification period for 5/1/24 to 6/29/24. The alternate administrator stated she did not know why Patient #1 was missing this comprehensive assessment and POC. The alternate administrator stated the agency’s EMR was missing documentation so it was possible the reassessment and POC was deleted. The alternate administrator also stated the 6/24/24 comprehensive assessment for Patient #1 completed by RN #3 was done a day early for the 6/30/24 to 8/28/24 certification period, thus failing to meet the regulatory requirement to complete the reassessment in the last 5 days of the 60 day certification period. Cross reference G546 4. The administrator failed to establish a plan of care (POC) which specified the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment for 1 of 5 active patients reviewed. During an interview on 7/2/24 at 2:31 p.m., the administrator stated she thought the 6/24/24 comprehensive assessment for Patient #1 was completed a day earlier for the 6/30/23 to 8/28/24 certification period, but she was not positive as she had been out and the alternate administrator and non-medical alternate agency manager were responsible for tracking and reminding clinicians when a patient was due for a comprehensive assessment. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions. During an interview on 7/2/24 at 9:15 a.m., the alternate administrator stated she was not familiar with Patient #1’s case. The alternate administrator reviewed Patient #1’s clinical record and stated Patient #1 had a comprehensive assessment completed on 3/1/24 by RN #3 and Patient #1’s next comprehensive assessment was completed on 6/24/24 by RN #3, 115 days later. The alternate administrator acknowledged Patient #1 was missing a comprehensive assessment that should have been completed between 4/26/24 to 4/30/24 and failed to have a POC for the certification period for 5/1/24 to 6/29/24. The alternate administrator also acknowledged Patient #1 did not have continuation of care orders after 4/30/24. The alternate administrator stated she did not know why Patient #1 was missing the comprehensive assessment, POC and/or continuation orders for care provided to Patient #1 from 5/1/24 through 6/24/24. The alternate administrator stated the agency’s EMR was missing documentation so it was possible the reassessment and POC was deleted. Cross Reference G570 (Condition) 5. The administrator failed to have a complete and accurate POC for 2 of 5 active patient records reviewed. During an interview on 7/2/24 at 9:36 a.m., the alternate administrator reviewed Patient #1’s clinical record and stated per the documented orders Patient #1 was to receive 40 units of Lantus Solorstar subcutaneously during her last shift of the evening. The administrator stated she was unaware LPN #5, LPN #11 or RN #3 had documented from 4/1/24 through 4/30/24 they administered 50 units each day during the last shift of the day. The administrator stated when Patient #1’s Lantus dose changed from 40 units subcutaneously to 50 units subcutaneously, she would have expected the LPN or RN who noticed the change in dosage to call Patient #1’s physician to receive a verbal order for the change or to write an updated medication order if the LPN/RN observed the prescription on the bottle in Patient #1’s home. The alternate administrator stated if either of those orders had been written, the dosage would have been updated on the POC and all subsequent POCs. The alternate administrator acknowledged this did not occur for Patient #1 and she was unsure why. During an interview on 7/2/24 at 2:31 p.m., the administrator was informed by the survey team they had several more questions for her regarding patient specific questions. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions. Cross Reference G574 6. The administrator failed to ensure services and treatments were administered by staff only as ordered by a physician in 6 of 7 patients reviewed. During an interview on 7/2/24 at 8:39 a.m., the alternate administrator, reviewed the POC for Patient #1 and agreed there were no orders to hold the HumaLOG insulin injection for any reasons. The alternate administrator also reviewed the SN notes and could not find documentation of the physician being notified that the medication was held for Patient #1. During an interview on 7/2/24 at 8:39 a.m., the alternate administrator, reviewed the POC for Patient #2 and agreed there were no verbal orders to continue care for Patient #2. During an interview on 7/2/24 at 10:09 a.m., the alternate administrator reviewed the record for Patient #4 and agreed she could not find any wound care orders. The alternate administrator went on to state, the last orders for wound care were put into Patient #4’s chart on 6/6/23 or about one year ago. The alternate administrator agreed there was no wound care for SN visits to follow. Cross Reference G580 7. The administrator failed to ensure the individualized plan of care (POC) was reviewed and revised by the physician once every 60 days beginning with the start of care date for 3 of 7 patient records reviewed (Patients #1, #5 and #7). During an interview on 7/2/24 at 1:58 p.m., the administrator stated it was missed because there was so much on her plate as she did not have enough staff to cover everything. During an interview on 7/2/24 at 10:09 a.m., the alternate administrator reviewed the record for Patient #5 and agreed the POC for the period of 4/1/24 to 5/30/24 had not yet been signed by the physician and it was late. During an interview on 6/27/24 at 2:52 p.m., the alternate administrator was not able to explain why the POC was not reviewed and signed by the physician until 15 days after the end of the certification period. The alternate administrator agreed the POC for the certification period 1/26/24 to 3/25/24 was not reviewed or revised by the physician every 60 days. Cross Reference G588 8. The administrator failed to utilize quality indicator data in the design of its program and to monitor the effectiveness and safety of services, quality of care, and opportunities for improvement. During an interview on 7/2/24 at 1:59 p.m., the administrator stated she had not thought about the aggregation of data. The administrator stated the agency collected data via chart audits and this was how the agency was made aware of some of the issues, but had not actually aggregated the data. The administrator stated she understood that without aggregated data, the agency could not demonstrate how the performance improvement projects (PIPs) had improved any issues since there are no before and after data points to compare. The administrator stated she would need to fix this issue. Cross Reference G644 (Standard) 9. The administrator failed to ensure clinical records contained accurate documentation of pertinent past and current findings in accordance with accepted professional standards for 1 of 5 active patients records reviewed. During an interview on 6/26/24 at 11:47 a.m., the alternate administrator stated the intervention notes section of the skilled nurse (SN) notes were autofilled by the EMR system with the type of intervention to be done with the patient. The alternate administrator stated she did not realize nurses were documenting in the intervention notes section. The alternate administrator stated SN should document comments about their visit in the general notes section of the note. The alternate administrator stated the intervention notes should be the intervention information from the POC, and not what intervention was completed on the visit. The alternate administrator agreed the intervention notes for RNs #8 and #9 did not match. Cross Reference G716 10. The administrator failed to ensure a supervising RN provided consistent and appropriate day-to-day oversight and supervision of LPNs providing patient care for 2 of 7 patient records reviewed. During an interview on 6/27/24 at 3:15 p.m., the alternate administrator reviewed Patient #7’s record and acknowledged Patient #7 received nine visits total provided by LPNs #5 and #11 between 12/1/23 and 1/24/24 and Patient #7’s first documented RN visit was on 1/25/24 for the comprehensive visit documented as completed by RN #8, scheduled as completed by RN #3 and had a corresponding late entry order documented by RN #3. The alternate administrator stated she did not know why Patient #7 was not assessed first by an RN as agency policy and regulation required as this was before she became the alternate administrator and director of nursing for the agency (appointed on 5/22/24). The alternate administrator stated she could not explain why the 1/25/24 and 3/21/24 comprehensive assessments were digitally signed by RN #8 who stated she had never met Patient #7. The alternate administrator also stated she could not explain why Patient #7’s calendar stated RN #3 provided the 1/25/24 RN visit when RN #3 stated she had not met Patient #7 in January nor did she know how to complete the paperwork for a comprehensive assessment until 2/13/24. During continued interview, the administrator acknowledged the agency failed to ensure a RN provided an initial assessment of Patient #7 prior to LPN #5 providing a visit to Patient #7 on 12/1/23 or prior to the eight other visits provided between LPNs #5 and #11 from 12/8/23 through 1/19/24. The failure to have RN oversight for Patient #7 from 12/1/23 through 1/24/24 the administrator stated this was an oversight on the agency’s part. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions. During an interview on 7/2/24 at 10:35 a.m., the alternate administrator acknowledged a patient had a right to refuse to let a specific clinician assess a wound, but agreed the agency was responsible for ensuring the wound was assessed by an RN. During an interview on 7/2/24 at 2;27 p.m., the survey team attempted to ask the administrator patient specific questions including why the agency failed to ensure and RN provided oversight for the wound care provided to Patient #4. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions. Cross Reference G726 11. The administrator failed to ensure patients had an emergency preparedness plan which included strategies for addressing emergency events identified by the risk assessment in 5 of 5 active patient records reviewed. During an interview on 7/2/24 at 2:10 p.m., the administrator confirmed the nurses were completing an individualized emergency preparedness plan when performing the comprehensive assessment on a paper form, however the agency failed to ensure the emergency preparedness plan was specific to the emergencies identified in the agency’s risk assessment for potential disasters. Cross Reference E006 (Standard) 12. The administrator failed to ensure the emergency preparedness training, and testing program reflected the risks identified in the agency’s risk assessment and within their emergency plan. Additionally, the agency failed to ensure a training process outlined within its emergency preparedness program which included staff and volunteer training based on the risks identified in the agency’s assessment. During an interview on 7/2/24 at 1:59 p.m., the administrator stated she had done a tornado drill and a fire drill but had not completed training specific to the emergencies identified as high in the agency’s risk assessment. The administrator stated she would review the emergency preparedness regulations and make changes as needed. During an interview on 7/2/24 at 1:59 p.m., the administrator stated the field staff took a written emergency preparedness test but did not participate in the tornado drill on 1/5/24. The administrator went on to state the agency did not have field staff or patients participate in the emergency drills. Cross Reference E0036 (Standard)”

“Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: Based on interview and record reviews, the agency failed to ensure patients had an emergency preparedness plan which included strategies for addressing emergency events identified by the risk assessment in 5 of 5 active patient records reviewed (Patients #1, #2, #3, #4,and #5). Findings include: Agency policy According to the policy, “5.5 Comprehensive Assessment Requirements,” un-dated (in-part): “A registered nurse will perform a comprehensive assessment with the environmental component: Emergency Preparedness (individualized to the patient).” 1.A review of the agency’s emergency preparedness plan and risk assessment completed on 1/31/24, revealed the agency emergency preparedness training and testing plan exercises were to be based on agency identified high risks of winter storms, wildfires, hail/high winds, and terrorism. However, the agency performed emergency drills that did not reflect the emergency preparedness plan or risk assessment. 2. The clinical record for Patient #1 was reviewed on 6/24/24. The plan of care (POC) for the certification period dated 3/2/24 to 4/30/24 (the last documented POC in Patient #1’s record) revealed a start of care date of 11/8/22; diagnoses included type 2 diabetes mellitus, hypertension, hyperlipidemia, anxiety, acute kidney failure, and dyspnea. POC orders included skilled nursing (SN) visits three times a day for assessment and evaluation, medication management and weekly medication setup. a) The agency failed to ensure Patient #1 had an individualized emergency preparedness plan developed for specific disasters which included winter storms, wildfires, high winds and hail, and terrorist activities. Review of Patient #1’s record failed to reveal an individualized emergency preparedness in regards to the natural and man-made disasters. 3. The clinical record for Patient #2 was reviewed on 6/25/24. The POC for the certification period dated 3/4/24 to 5/2/24 revealed a start of care date of 1/9/23; diagnoses included gastro-esophageal reflux, essential (primary) hypertension, pain unspecified and obesity unspecified. POC orders included SN visits twice daily for 5 days per week for lymphedema management to apply low compression wraps. a) The agency failed to ensure Patient #2 had an individualized emergency preparedness plan developed for specific disasters which included winter storms, wildfires, high winds and hail, and terrorist activities. Review of Patient #2’s record failed to reveal an individualized emergency preparedness in regards to the natural and man-made disasters. 4. The clinical record for Patient #4 was reviewed on 6/26/24. The POC for the certification period dated 6/5/24 to 8/3/24 revealed a start of care date of 2/16/22; diagnoses included essential primary hypertension, hidradenitis suppurativa, and gastro-esophageal reflux disease without esophagitis. POC orders included SN visits twice a week for nine weeks for skilled assessment and wound care. a) The agency failed to ensure Patient #4 had an individualized emergency preparedness plan developed for specific disasters which included winter storms, wildfires, high winds and hail, and terrorist activities. Review of Patient #4’s record failed to reveal an individualized emergency preparedness in regards to the natural and man-made disasters. 5. Similar findings were found for Patients #3 and #5. 6. During an interview on 7/2/24 at 2:10 p.m., the administrator confirmed the nurses were completing an individualized emergency preparedness plan when performing the comprehensive assessment on a paper form, however the agency failed to ensure the emergency preparedness plan was specific to the emergencies identified in the agency’s risk assessment for potential disasters.”

“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 interview and record reviews, the agency failed to ensure the emergency preparedness training, and testing program reflected the risks identified in the agency’s risk assessment and within their emergency plan. Additionally, the agency failed to ensure a training process outlined within its emergency preparedness program which included staff and volunteer training based on the risks identified in the agency’s assessment. Findings include: Agency Policy According to the policy, “6.1 EMERGENCY PREPAREDNESS PLAN,” dated 1/31/24, (in-part): “All employees including contractors are orientated about their responsibilities in the Agency’s Emergency Preparedness and Response Plan on hire and the plan is reviewed annually with an emergency drill performed.” 1. During an interview on 7/2/24 at 8:18 a.m., the alternate administrator (also the director of nursing, DON) stated she was not present at the agency when emergency training and testing was performed. She said the agency completed a tornado drill on 1/5/24 and she believed all office based staff and patient care staff participated in the drill. The DON said, staff participate in online emergency preparedness training at hire, annually, and during staff meetings. The agency received a signed confirmation from participants after training in staff meetings was performed. However, this training did not specifically address the agency’s risk assessment findings of winter storms, wildfires, hail/high winds, and terrorism. a. The agency failed to ensure the emergency preparedness training, and testing program reflected the high risks of winter storms, wildfires, hail/high winds, and terrorism identified in the agency’s risk assessment and within their emergency plan. A review of the agency’s emergency preparedness plan and risk assessment completed on 1/31/24, revealed the agency emergency preparedness training and testing plan exercises were to be based on agency identified high risks of winter storms, wildfires, hail/high winds, and terrorism. However, the agency performed emergency drills that did not reflect the emergency preparedness plan or risk assessment. During an interview on 7/2/24 at 1:59 p.m., the administrator stated she had done a tornado drill and a fire drill but had not completed training specific to the emergencies identified as high in the agency’s risk assessment. The administrator stated she would review the emergency preparedness regulations and make changes as needed. b. The agency failed to ensure an emergency testing and training program process outlined within its emergency preparedness program included staff and volunteer training in risks of winter storms, wildfires, hail/high winds, and terrorism. A review of the agency’s completed emergency exercises included a tornado drill on 1/5/24, and a fire drill on 1/15/24. Further review revealed the administrator, staff manager, and human resource manager conducted the training exercise and did not include field or clinical staff in the annual training exercises. During an interview on 7/2/24 at 1:59 p.m., the administrator stated the field staff took a written emergency preparedness test but did not participate in the tornado drill on 1/5/24. The administrator went on to state the agency did not have field staff or patients participate in the emergency drills.”

“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 ensure each beneficiary who received Medicare, a Medicare advantage plan, and/or Medicaid’s Outcome and Assessment Information Set (OASIS) was electronically encoded and transmitted to the Centers for Medicare and Medicaid Services (CMS) in 5 of 5 active patient records reviewed (Patients #1, #2, #3, #4, and #5); and based on interview and record review of CMS OASIS Error Detail report, the agency failed to electronically transmit current and accurate data regarding each beneficiary with respect to which information was required to be transmitted within 30 days of completing the assessment of the beneficiary for 13 patients whose data was transmitted from 6/1/23 through 6/24/24. Findings include: AGENCY POLICY According to an undated agency policy titled, Collection, Reporting, and Transmission of OASIS DATA, (read in pertinent parts): “The HHA [home health agency] electronically reports all OASIS data collected from the comprehensive assessment.” “HHAs must continue to collect, encode, and transmit OASIS data for their non-maternity Medicare (traditional and HMO [health maintenance organization] and Medicaid (traditional and HMO/Managed care) patients that are age 18 and over and receiving skilled services. Medicare (HMO/managed care) does include Medicare Advantage (MA) formerly known as Medicare+Choice (M+C) plans and Medicare PPO [preferred provider organization] plans.” “Activities and implementation must include, at a minimum: -Data is transmitted within 30 days of completing assessments.” A. The agency failed to ensure all patients who had Medicare, including Medicare advantage/HMO/PPO and Medicaid insurance plans OASIS data was submitted to CMS. 1. The clinical record for Patient #2 was reviewed on 6/25/24. The plan of care (POC) for the certification period dated 5/3/24 to 7/1/24 revealed a start of care date of 1/9/23; diagnosis included gastro-esophageal reflux disease, hypertension, bilateral knee primary osteoarthritis, pain, obesity, and asthma. POC orders included skilled nursing (SN) visits two times a day five days for 56 to 60 days for assessment, lymphedema management and education. a. The agency failed to ensure Patient #2’s OASIS was transmitted to CMS. On 6/25/24, review of Patient #2’s insurance information revealed Patient #2 had a Medicare advantage plan and Medicaid. On 6/25/24, review of the recertification OASIS assessments for Patient #2 dated 2/29/24 and 5/2/24, transfer to inpatient facility, not discharged from the agency (TIF) OASIS completed on 5/6/24, and resumption of care (ROC) OASIS completed on 5/10/24 showed, Patient #2 was identified to have Medicare (HMO/managed care) and Medicaid. Review of the OASIS agency final validation report from 6/1/23 to 6/24/24, revealed the agency was transmitting OASIS for 13 patients; Patient #2 was not a patient who was noted to have OASIS transmitted to CMS. 2. The clinical record for Patient #5 was reviewed on 6/25/24. The POC for the certification periods dated 2/1/24 to 3/31/24, 4/1/24 to 5/30/24 and 5/31/24 to 7/29/24 revealed a start of care date of 12/19/22; diagnoses included stage 4 chronic kidney disease, hypercalcemia, anemia, osteoarthritis, glaucoma, and disorder of thyroid. POC orders included certified nursing assistant (CNA) visits two times daily for assistance with activities of daily living (ADLs) and instrumental ADLS (complex tasks people do daily to take care of themselves and their homes such as managing finances, taking medication and preparing food). a. The agency failed to ensure Patient #5’s OASIS was transmitted to CMS. On 6/25/24, a review of Patient #5’s insurance information revealed Patient #5 had a Medicaid insurance plan. On 6/25/24, review of the recertification OASIS assessments for Patient #5 dated 2/8/24 and 6/10/24, Patient #5 was identified to have Medicaid. Review of the OASIS agency final validation report from 6/1/23 to 6/24/24, revealed the agency was transmitting OASIS for 13 patients; Patient #5 was not a patient who was noted to have OASIS transmitted to CMS. 3. The clinical record for Patient #1 was reviewed on 6/24/24. The POC for the certification period dated 3/2/24 to 4/30/24 (the last documented POC in Patient #1’s record- Cross Reference G574) revealed a start of care date of 11/8/22; diagnoses included type 2 diabetes mellitus, hypertension, hyperlipidemia, anxiety, acute kidney failure, and dyspnea. POC orders included SN visits three times a day for assessment and evaluation, medication management and weekly medication setup. a. The agency failed to ensure Patient #1’s OASIS was transmitted to CMS. On 6/24/24, a review of Patient #1’s insurance information revealed Patient #1 had a Medicaid insurance plan. On 6/24/24, review of the recertification OASIS assessments for Patient #1 dated 12/28/23, 3/1/24 and 6/24/24, Patient #1 was identified to have Medicaid. Review of the OASIS agency final validation report from 6/1/24 to 6/24/24, revealed the agency was transmitting OASIS for 13 patients; Patient #1 was not a patient who was noted to have OASIS transmitted to CMS. 4. Similar findings of the agency’s failure to ensure all beneficiaries’ OASIS data was transmitted to CMS was revealed in the records of Patients #3 and #4. 5. During an interview on 6/26/24 at 1:42 p.m., the alternate administrator stated the administrator was the only agency employee who knew how to transmit OASIS data to CMS. The alternate administrator stated the administrator was supposed to train her how to transmit OASIS data, but she was unable to train her on this task prior to going out on medical leave in early May 2024. During an interview on 7/2/24 at 1:58 p.m., the administrator acknowledged she was the only employee trained on how to submit OASIS data. The administrator stated she was taught by the previous administrator, she only had to transmit data for patients who had traditional Medicare insurance plans. The administrator stated she was unaware regulation required her to transmit data for all beneficiaries of Medicare and Medicaid. The administrator acknowledged the last transmission of OASIS data for the agency was on 4/18/24.The administrator stated she planned to train the alternate administrator on how to transmit OASIS data, but had been unable to train the alternate administrator prior to going out on medical leave in early May 2024. B. The agency failed to ensure OASIS data was transmitted within 30 days of completing the assessment. 1. Review of the OASIS Error detail report from 6/1/23 through 6/24/24 revealed 49 assessments, which pertained to 13 different patients, were submitted more than 30 days after the “M0090” date, which was the last date information used to complete the comprehensive assessment and determine the OASIS coding gathered by the assessing clinician. 2. Review of the OASIS validation report for 6/1/23 through 6/24/24 revealed Patient A had his OASIS submitted on 8/14/23, for the following assessments: - an assessment that had been completed on 7/16/22, approximately 394 days after the completion of the assessment; -an assessment that had been completed on 8/13/22, approximately 366 days after the completion of the assessment; -an assessment that had been completed on 10/12/22, approximately 307 days after the completion of the assessment; -an assessment that had been completed on 12/15/22, approximately 243 days after the completion of the assessment; -an assessment that had been completed on 2/10/23, approximately 186 days after the completion of the assessment; -an assessment that had been completed on 2/20/23, approximately 176 days after the completion of the assessment; -an assessment that had been completed on 3/8/23, approximately 159 days after the completion of the assessment; -an assessment that had been completed on 4/13/23, approximately 124 days after the completion of the assessment; and -an assessment that had been completed on 6/13/23, approximately 63 days after the completion of the assessment. Review of the OASIS validation report for 6/1/23 through 6/24/24 revealed Patient #6 had his OASIS submitted on 2/9/24, for an assessment that had been completed on 10/10/23, approximately 123 days after the completion of the assessment; and his OASIS submitted on 2/9/24 for an assessment that had been completed on 12/8/23, approximately 64 days after the completion of the assessment. Review of the OASIS validation report for 6/1/23 through 6/24/24 revealed Patient B had her OASIS assessment submitted on 4/18/24, for an assessment that had been completed on 1/25/24, 84 days after the completion of the assessment. Similar findings of the agency failing to submit accurate OASIS assessments within the 30 day timeframe required by regulation was found for assessments submitted for the other 10 patients reviewed on the agency’s OASIS validation report from 6/1/23 to 6/24//24. 2. During an interview on 7/2/24 at 1:58 p.m., the administrator stated she was the only employee who knew how to submit OASIS data. The administrator acknowledged she was late submitting OASIS data due to being short staffed at the agency and the administrator prioritizing ensuring patient care needs were met over submitting OASIS data.”

“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 utilize quality indicator data in the design of its program and to monitor the effectiveness and safety of services, quality of care, and opportunities for improvement. Findings include: AGENCY POLICY According to the undated agency policy titled “QAPI Activity Requirements” read in pertinent parts: “The agency measures, analyzes and track quality indicators, including adverse patient events and other aspects of performance that enabled the agency to assess processes of care, service and operations” 1. Review of the Quality Assessment/Performance Improvement (QAPI) documentation revealed the agency was currently working on three performance improvement projects (PIPs) including missed visit documentation, verbal orders, and supervisory visits. Review of the three PIPs revealed the agency had reports of missed visit documentation being incorrect, supervisory visits not being performed on time, and verbal orders not being recorded correctly. However there was no evidence data had been analyzed and aggregated in order to monitor the effectiveness of the PIPs the agency had implemented. During an interview on 7/2/24 at 1:59 p.m., the administrator stated she had not thought about the aggregation of data. The administrator stated the agency collected data via chart audits and this was how the agency was made aware of some of the issues, but had not actually aggregated the data. The administrator stated she understood that without aggregated data, the agency could not demonstrate how the PIPs had improved any issues since there are no before and after data points to compare. The administrator stated she would need to fix this issue.”

“Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This Element is not met as evidenced by: Based on interview and record review the agency failed to document the resolution of a patient complaint for 1 of 1 patient records reviewed who called the agency with a complaint (Patient #7). Finding include: 1. The clinical record for Patient #7 was reviewed on 6/24/24. The plan of care (POC) for the certification period dated 5/25/24 to 7/23/24 revealed a start of care date of 11/27/23; diagnosis included iron deficiency anemia, protein-calorie malnutrition, hypokalemia and toxic megacolon. POC orders included skilled nursing (SN) visits one time a week and as needed (PRN) for assessment and evaluation, education and colostomy (a small, waterproof pouch that collects stool from the digestive tract through an opening in the abdominal wall) care. a) The agency failed to ensure documentation of the resolution to Patient #7’s complaint was completed. Review of the agency complaint log on 6/24/24 failed to reveal documentation of any complaints or their resolution. On 6/24/24, review of Patient #7’s communication notes from 2/6/24 to 6/19/24 revealed a communication note documented on 6/10/24 by the human resource (HR) manager which stated Patient #7 called the agency on 6/8/24 at 11:45 a.m. requesting a SN come and assist her with her leaking colostomy bag (a small, waterproof pouch that collects stool from the digestive tract through an opening in the abdominal wall). The HR manager documented at 12:30 p.m., an employee of Patient #7’s assisted living residence (ALR) called the agency to inquire when an agency SN could come assist Patient #7 with her leaking colostomy bag. The HR manager informed the ALR employee the agency only had one SN, licensed practical nurse (LPN #11), working and she would not be able to come see Patient #7 until she finished at her other job after 7:00 p.m., if she could come at all on 6/8/24 to see Patient #7. At 7:05 p.m., LPN #11 informed the human resource manager she could not see Patient #7 on 6/8/24. The HR manager called Patient #7’s ALR and informed the employee she had been communicating with throughout the day that LPN #11 would not be able to see Patient #7 on 6/8/24. The HR manager documented she sought advice from the agency administrator on what options she could provide Patient #7, and the administrator told her to inform Patient #7 and her ALR the agency could send a SN the morning of 6/9/24 or if Patient #7 could not wait, she could go to the emergency room to have her colostomy bag changed. The HR manager documented the ALR employee expressed her unhappiness with this answer and inquired about how Patient #7 could be discharged from the agency. The HR manager stated if Patient #7 requested to be discharged, the agency would assist with the process as quickly as possible. The HR manager requested the ALR employee call the agency back after speaking with Patient #7 to let the agency know if Patient #7 wanted a visit on the morning of 6/9/24 or not. The HR manager documented she never received a phone call back from either Patient #7 or the ALR employee from the evening of 6/8/24 through the morning of 6/10/24. Review of SN notes revealed LPN #11 provided Patient #7 with a PRN visit on 6/9/24 from 12:55 p.m. to 2:35 p.m. to assist Patient #7 with her leaking colostomy bag. Continued review of Patient #7’s communication notes from 2/6/24 to 6/19/24 revealed a communication note documented on 6/10/24 by the HR manager which stated Patient #7 called the agency on 6/10/24 at 11:37 a.m., requesting to speak with someone in charge regarding her “horrible experience over the weekend.” The HR manager documented she informed Patient #7 she would direct Patient #7’s request to the administrator and the administrator informed the HR manager she would contact Patient #7 on 6/10/24 to discuss her concerns. Further review of the communication notes in Patient #7’s clinical record, and the complaint log failed to show the administrator or any other employee documented the resolution to Patient #7’s 6/10/24 complaint. During an interview on 6/26/24 at 12:32 p.m., the HR manager stated she was the person on-call for the agency the weekend of 6/8/24-6/9/24. The HR manager stated she informed the administrator of Patient #7’s complaint on 6/10/24 and she overhead the administrator speaking to Patient #7 on the phone around 1:00 p.m. on 6/10/24. The HR manager stated she could not locate documentation of the administrator’s conversation with Patient #7 or the resolution to Patient #7’s complaint. During an interview on 7/2/24 at 2:19 p.m., the administrator stated, although she had been on medical leave from early May 2024, she did come into the office on 6/10/24 and called Patient #7. The administrator stated Patient #7 appeared confused during her conversation with the administrator as Patient #7 first stated LPN #11 never came to see her on 6/9/24 and then stated she did. The administrator stated Patient #7 expressed concerns about not knowing her options on how to get her leaking colostomy bag fixed on 6/8/24. The administrator stated Patient #7 informed the administrator she was not told by the ALR employee the agency had offered to send LPN #11 to see her on 6/9/24. Additionally, the administrator stated the ALR employee attempted to call agency nurses directly instead of communicating to the agency via the on-call number which led to miscommunication. The administrator stated she educated Patient #7 to call the office, not agency nurses directly if she had any future issues to try to prevent any further miscommunication, and Patient #7 appeared to be satisfied with this resolution. The administrator acknowledged she failed to document her conversation with Patient #7 either in Patient #7’s communication log or in the complaint log. The administrator stated she was in and out of the office as she was on medical leave and was too “lackadaisical” at times with the timeliness of her documentation. The administrator stated she would work on improving her timeliness of documentation and education to staff on what information should be included in the complaint log.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure an initial assessment was provided within 48 hours of referral by a physician for 2 of 7 patients reviewed (Patients #2 and #7). Findings include: AGENCY POLICY According to an undated agency policy titled, Initial Assessment Requirements, (read in pertinent parts): “All patients, referred for services, have an initial assessment. The initial assessment is conducted within 48 hours of referral, and/or within 48 hours of the patient’s return home or on the physician’s ordered start of care date.” 1. During an interview on 6/26/24 at 11:47 a.m., the alternate administrator, who was also the director of nursing, stated the agency expected clinicians to complete the start of care assessment within 48 hours of the agency receiving the referral. The alternate administrator stated if a clinician was unable to complete the start of care assessment within 48 hours, the agency would obtain a verbal order to delay the patient’s start of care assessment with the reason for the delay documented on the verbal order. 2. The clinical record for Patient #2 was reviewed on 6/25/24. The plan of care (POC) for the certification period dated 5/3/24 to 7/1/24 revealed a start of care date of 1/9/23; diagnosis included gastro-esophageal reflux disease, hypertension, bilateral primary osteoarthritis of knee, pain, obesity, and asthma. POC orders included skilled nursing (SN) visits two times a day five days for 56 to 60 days for assessment, lymphedema management and education. a) The agency failed to complete a comprehensive assessment within 48 hours of receipt of the referral for Patient #2. Specifically, the agency completed the assessment 11 days after receipt of the referral. Review of the clinical record revealed referral documentation sent to the agency on 12/30/22 at 5:39 p.m. via fax from Patient #2’s primary care physician (PCP) office ordering home health care without a discipline specified. Review of the clinical record revealed registered nurse (RN) #8 completed a comprehensive assessment with Patient #2 on 1/9/23, 11 days after the agency received the referral. Record review failed to show a delayed start of care order for 1/9/23. Review of communication notes failed to show why Patient #2’s start of care was delayed 11 days after the agency’s receipt of the referral. During a home visit on 6/24/24 at 12:06 p.m., Patient #2 and RN #8 both stated RN #8 had provided care to Patient #2 for approximately nine years. Patient #2 and RN #8 both stated RN #8 had worked for a few agencies over the course of the nine years the two had worked together and Patient #2 followed RN #8 to receive care from the agency RN #8 worked at. Patient #2 and RN #8 stated they could not recall the specifics of Patient #2’s start of care with A Better Colorado Home Healthcare. During an interview on 6/26/24 at 11:47 a.m., the alternate administrator reviewed Patient #2’s record and stated Patient #2’s record failed to contain a delayed start of care order or communication note explaining why Patient #2’s start of care was delayed. The alternate administrator stated she did not know why Patient #2’s start of care was delayed. During an interview on 6/26/24 at 12:54 p.m., the alternate administrator stated she spoke with the administrator, who was on medical leave from the agency, and the administrator could not recall why Patient #2’s start of care was delayed. 3. The clinical record for Patient #7 was reviewed on 6/24/24. The POC for the certification period dated 11/27/23 to 1/25/24 revealed a start of care date of 11/27/23; diagnosis included iron deficiency anemia, protein-calorie malnutrition, hypokalemia and toxic megacolon. POC orders included physical therapy (PT) to assess, evaluate and treat. a) The agency failed to complete a comprehensive assessment within 48 hours of receipt of the referral for Patient #7. Specifically, the agency completed the assessment 11 days after the receipt of the referral and 10 days after Patient #7 was discharged home from a skilled nursing facility (SNF). Review of agency documentation showed the agency received referral documentation for Patient #7 on 11/17/23 from a SNF nurse practitioner (NP) who ordered PT upon Patient #7’s discharge to her assisted living residence (ALR) on 11/18/23. Review of the clinical record revealed PT #4 completed a comprehensive assessment with Patient #7 on 11/27/23, 10 days after Patient #7 discharged from the SNF. Review of interim orders failed to show a delayed start of care order for 11/27/23. Review of Patient #7’s communication notes on 6/24/24 failed to show why Patient #7’s start of care was delayed 10 days after Patient #7 discharged from the SNF. Review of Patient #7’s communication notes on 6/26/24 showed a late entry for 11/21/23 entered by the non-skilled alternate agency manager, Employee #7, which stated, “Patient was moving into a facility, and they did not have a room available for her at the time. [p]atient denied home health care until she was established in the facility. PCP notified multiple occasions[,] no orders received.” During an interview on 6/26/24 at 11:58 a.m., the alternate administrator stated she did not know why Patient #7’s start of care assessment was completed 10 days after Patient #7 discharged from a SNF to an ALR. The alternate administrator reviewed Patient #7’s record and acknowledged Patient #7’s record failed to contain a delayed start of care order or a communication note explaining why Patient #7’s start of care was delayed. During an interview on 6/26/24 at 12:43 p.m., the alternate administrator stated the administrator informed the alternate administrator Patient #7’s start of care was delayed as Patient #7’s move into her ALR was delayed. The alternate administrator stated Patient #7 declined her PT start of care assessment until she was moved into her new ALR. The alternate administrator stated the administrator informed the alternate administrator that the administrator had spoken to Patient #7’s PCP many times regarding Patient #7’s delayed start of care; and the administrator had documented these conversations in the administrator’s personal documentation. The administrator informed the alternate administrator she had failed to document these conversations in Patient #7’s communication notes and had failed to document a delayed start of care order for Patient #7.”

“Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure comprehensive assessments were performed in the last five days of a 60 day certification period for 2 of 4 active patient records reviewed who required a recertification comprehensive assessments (Patients #1 and #5). Findings include: AGENCY POLICY According to an undated agency policy titled, Update & Revision of Comprehensive Assessment, (read in pertinent parts): “The comprehensive assessment is 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 no less frequently than described in interpretive guidelines.” “-At a minimum, the comprehensive assessment must be updated, and revised, no less frequently than: -The last five days of every 60-days, beginning with the start of care date…” 1.During an interview on 6/28/24 at 11:36 a.m., the administrator stated she expected clinicians, either a registered nurse (RN) or physical therapist (PT), to complete comprehensive reassessments in the last 5 days of the 60 day certification period. The administrator stated the agency’s electronic medical record (EMR) system alerted the clinician when a patient was coming up to their five day reassessment window and the agency office also notified clinicians when a patient was coming due for a reassessment. The administrator stated when a clinician completed a comprehensive assessment, the procedure she expected the clinician to use was as follows: the clinician was to complete a head to toe assessment during a visit with the patient; contact the patient’s doctor and obtain a verbal order from the doctor for orders for continued care; and then the clinician was to use the agency’s EMR to generate the next plan of care (POC) for the patient. The administrator stated the agency did not have a director of nursing (DON) for the first five months of 2024, and she did the best she could to keep up on all of the agency’s needs including tracking and ensuring comprehensive reassessments were done timely and accurately and the corresponding POC were generated accurately and timely. The administrator stated things probably “slipped under the rug” due to her lack of help. The administrator stated she went out on medical leave on 5/8/24 and since that time the only work she had been doing for the agency was approving orders. The administrator stated any questions regarding missing items since 5/8/24 would need to be directed to the alternate administrator. During an interview on 7/2/24 at 8:56 a.m., the alternate administrator, who was also the agency’s DON since 5/22/24, stated the agency expected clinicians to complete comprehensive reassessments within the last five days of each certification period. The alternate administrator stated the agency encouraged clinicians to complete the paperwork for the reassessment and corresponding next certification period POC to be completed within 24 to 48 hours of the reassessment visit date. The alternate administrator stated prior to May of 2024, the administrator tracked on a whiteboard when a patient was due for a reassessment and the agency’s EMR also tracked when a patient was due for a reassessment. The alternate administrator stated since the administrator went out on medical leave in early May 2024, it was a team effort to track when patients were due for reassessments. The alternate administrator stated she and the non-skilled agency manager were attempting to track when a patient was due for a reassessment, but acknowledged the agency had fallen behind on scheduling and ensuring reassessments were completed in the last five days of a 60 day certification period. Additionally, the alternate administrator stated no one at the agency was ensuring clinician’s completed a patient’s reassessment and the corresponding paperwork including generating the new POC as scheduled. During an interview on 6/27/24 at 12:52 p.m., the non-medical alternate agency manager stated typically the administrator tracked when comprehensive reassessments were due, however, since the administrator went out on medical leave in early May of 2024, the non-medical alternate agency manager was attempting to keep track when patient’s comprehensive reassessments were due. The non-medical alternate agency manager stated the agency was behind on completing comprehensive reassessments as the administrator and licensed practical nurse (LPN) #5 were both out on medical leave. The non-medical alternate agency manager stated neither the administrator or LPN #5 completed comprehensive assessments prior to going out on leave, but in their absence, the agency was short staffed particularly for skilled nursing (SN) needs. 2. The clinical record for Patient #5 was reviewed on 6/25/24. The POC for the certification periods dated 2/1/24 to 3/31/24, 4/1/24 to 5/30/24 and 5/31/24 to 7/29/24 revealed a start of care date of 12/19/22; diagnoses included stage 4 chronic kidney disease, hypercalcemia, anemia, osteoarthritis, glaucoma,and disorder of thyroid. POC orders included certified nursing assistant (CNA) visits two times daily for assistance with activities of daily living (ADLs) and instrumental ADLs (complex tasks people do daily to take care of themselves and their homes such as managing finances, taking medication and preparing food). a) The agency failed to ensure a comprehensive assessment was performed in the last five days of the 60 day certification period. Review of the clinical record for Patient #5 revealed a new 60 day certification period started on 2/1/24 and the 60 day certification period was from 2/1/24 to 3/31/24. Further review of the clinical record revealed the five day reassessment window was from 1/27/24 to 1/31/24, however, RN #3 did not complete a comprehensive assessment until 2/8/24, eight days after the start of the new certification period and the assessment was digitally signed by RN #3 on 2/9/24. Additionally, the 2/8/24 comprehensive assessment inaccurately stated the certification period was from 2/8/24 to 4/11/24. Review of the clinical record for Patient #5 revealed a new 60 day certification period started on 4/1/24 and the 60 day certification period was from 4/1/24 to 5/30/24. Further review of the clinical record revealed the five day reassessment window was from 3/27/24 to 3/31/24, however the agency failed to have a RN complete an assessment for the 4/1/24 to 5/30/24 certification period. Review of the clinical record for Patient #5 revealed a new 60 day certification period started on 5/31/24 and the 60 day certification period was from 5/31/24 to 7/29/24. Further review of the clinical record revealed the five day reassessment window was from 5/26/24 to 5/30/24, however, RN #9 (who resigned her position with the agency during the survey on 6/25/24) did not complete a comprehensive reassessment until 6/10/24, 11 days after the start of the new certification period. Additionally, the 6/10/24 comprehensive assessment inaccurately stated the certification period was from 6/11/24 to 8/9/24. During an interview on 6/27/24 at 10:30 a.m., Patient #5 stated she received CNA visits twice a day everyday of the week except on Saturdays for assistance with ADLs including donning and doffing her compression stockings. Patient #5 stated she had never had a nurse from the agency come out to do a comprehensive assessment with her and Patient #5 stated she had never met RN #3 or #9. During an interview on 6/26/24 at 3:50 p.m., RN #3 stated she worked per diem for the agency and learned on 2/13/24 from the agency administrator how to complete a comprehensive assessment for a patient. RN #3 stated she was unaware of the regulatory timeframe on when comprehensive reassessments were due. RN #3 stated agency management would inform her via a text message when they had a reassessment for her to complete. RN #3 stated when the administrator educated her in February 2024 how to complete a comprehensive assessment, the administrator told her it was important for RN #3 to complete the assessment on the day the agency scheduled her to complete the assessment as the assessment date had to align appropriately with the corresponding certification window. RN #3 stated, the administrator also informed RN #3 if she could not complete the assessment on the day assigned to make sure she documented the assessment was completed on the assigned date to not throw the assessment date off from the corresponding certification period. During continued interview, RN #3 stated she had never met Patient #5 and did not complete the 2/8/24 comprehensive reassessment for Patient #5 as she did not know how to complete the paperwork for this type of assessment until 2/13/24. RN #3 also stated she always signed her assessments and was not aware documents could be digitally signed in the agency’s EMR. The survey team attempted to interview RN #9 at 11:00 a.m. on 6/26/24, but was unable to reach RN #9, thus a message was left requesting a call back. On 6/26/24 at 11:48 a.m., the survey team received a text message from RN #9 informing the survey team RN #9 no longer worked for the agency. The non-skilled agency manager informed the survey team on 6/26/24 at 11:45 a.m. RN #9 resigned her position as RN case manager at 5 p.m. on 6/25/24. During an interview on 6/27/24 at 2:52 p.m., the non-skilled agency manager stated she was aware the agency’s EMR system was inaccurately assigning patients to RN case managers after the EMR had a software update. The non-skilled agency manager stated RN #8 called the administrator to complain about being assigned to at least three patients she was not overseeing. The non-skilled agency manager stated the administrator had called the agency’s EMR company to attempt to get the issue resolved and had removed RN #8 as the assigned case manager for the three patients RN #8 stated she was not following. The non-skilled manager stated she did not know how a digital signature could be applied to the system without the clinician’s password. The non-skilled agency manager stated she had never assigned RN #3 to complete a recertification comprehensive assessment for Patient #5, but acknowledged she had assigned RN #9 to complete the 6/10/24 recertification comprehensive assessment for Patient #5. During an interview on 6/28/24 at 1:05 a.m., the non-skilled agency manager and the agency’s human resource manager stated they could not provide the survey team with any documentation on why nurses names were appearing digitally signed on assessments the RN stated they did not complete. During an interview on 6/28/24 at 11:47 a.m., the administrator stated she did not know how clinician’s digital signatures were appearing on assessments the clinician and patient denied were completed by the clinician. The administrator stated no employee could digitally sign for another employee without having the clinicians password. During an interview on 7/1/24 at 9:08 a.m., a representative for the agency’s EMR company stated a clinician’s digital signature was unique to each user and in order to insert a digital signature on a document the person inserting the signature would need the clinician’s username and password. The representative for the agency’s EMR company stated there were three ways she could think of how another person might be able to insert a clinician’s digital signature on a document: the clinician provided their username and password to the person inserting the digital signature; the person inserting the digital signature was using a device where the clinician’s username and password was stored on the device; or the person inserting the digital signature had reset the clinician’s password. During an interview on 7/2/24 at 2;27 p.m., the administrator stated RN #3 was trained how to do start of care and recertification comprehensive assessments on her date of hire (1/4/23). The administrator stated RN #3 worked per diem (as needed) for the agency and requested a retraining on how to complete start of care and recertification comprehensive assessments in February 2024, and the administrator accompanied RN #3 on a few visits in February 2024 to provide this training. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions regarding late comprehensive assessments. During an interview on 7/2/24 at 10:43 a.m., the alternate administrator stated she reviewed Patient #5’s record and acknowledged the certification periods in the record were not accurately documented and were not accurately documented on the comprehensive assessments completed for Patient #5. The alternate agency manager stated it would take her awhile to figure out how to correct the inaccurate dates documented in Patient #5’s clinical record for certification periods and comprehensive assessments. During continued interview, the alternate administrator stated to the best of her knowledge, back in 2022 an RN started Patient #5’s care and then a physical therapist (PT) completed a new certification period and the inaccurate dating of certification periods particularly on comprehensive assessments began during this time. The alternate administrator stated she believed the accurate certification periods for Patient #5 were 2/1/24 to 3/31/24, 4/1/24 to 5/30/24 and 5/31/24 to 7/29/24. The alternate administrator stated the recertification comprehensive assessment completed on 2/8/24 was completed late for the 2/1/24 to 3/31/24 certification period; the EMR failed to show a recertification comprehensive assessment for the 4/1/24 to 5/30/24 certification period; and the 6/10/24 recertification comprehensive assessment was the reassessment completed late for the 5/31/24 to 7/28/24 certification period. During an interview on 6/27/24 at 9:49 a.m., the alternate administrator stated Patient #5 had a recertification comprehensive assessment completed for the certification period 4/1/24 to 5/30/24, but acknowledged this recertification comprehensive assessment was not documented in the agency’s EMR. The alternate administrator stated any clinician with access to the EMR could delete items from the EMR so it was possible a disgruntled employee had deleted Patient #5’s recertification comprehensive assessment for the certification period dated 4/1/24 to 5/30/24. 3. The clinical record for Patient #1 was reviewed on 6/24/24. The POC for the certification period dated 3/2/24 to 4/30/24 (the last documented POC in Patient #1’s record- Cross Reference G570) revealed a start of care date of 11/8/22; diagnoses included type 2 diabetes mellitus, hypertension, hyperlipidemia, anxiety, acute kidney failure, and dyspnea. POC orders included SN visits three times a day for assessment and evaluation, medication management and weekly medication setup. a) The agency failed to ensure a comprehensive assessment was performed in the last five days of the 60 day certification period. Review of the clinical record for Patient #1 revealed a new 60 day certification period started on 5/1/24 and the 60 day certification period was from 5/1/24 through 6/29/24. Further review of the clinical record revealed the five day reassessment window was from 4/26/24 to 4/30/24, however, the agency failed to have a RN complete an assessment for the 5/1/24 to 6/29/24 certification period. Review of the clinical record for Patient #1 revealed a new 60 day certification period started on 6/30/24 and the 60 day certification period was from 6/30/24 through 8/28/24. Further review of the clinical record revealed the five day reassessment window was from 6/25/24 to 6/29/24, however, RN #3 performed the reassessment on 6/24/24, one day earlier than the five day reassessment window. During an interview on 6/26/24 at 3:50 p.m., RN #3 acknowledged she completed a comprehensive reassessment for Patient #1 on Monday 6/24/24 per the direction of the agency’s non-medical alternate manager, Employee #7. RN #3 stated she had just recently learned how to generate a POC from the comprehensive assessment and she had not had time to complete the paperwork to generate the POC that corresponded with the 6/24/24 comprehensive reassessment she completed with Patient #1. RN #3 stated she did not know why a comprehensive reassessment or POC was not completed for the certification period 5/1/24 to 6/29/24 for Patient #1. During an interview on 7/2/24 at 2:31 p.m., the administrator stated she thought the 6/24/24 comprehensive assessment for Patient #1 was completed a day earlier for the 6/30/23 to 8/28/24 certification period, but she was not positive as she had been out and the alternate administrator and non-medical alternate agency manager were responsible for tracking and reminding clinicians when a patient was due for a comprehensive assessment. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions regarding late comprehensive assessments. During an interview on 7/2/24 at 9:15 a.m., the alternate administrator stated she was not familiar with Patient #1’s case. The alternate administrator reviewed Patient #1’s clinical record and stated Patient #1 had a comprehensive assessment completed on 3/1/24 by RN #3 and Patient #1’s next comprehensive assessment was completed on 6/24/24 by RN #3, 115 days later. The alternate administrator acknowledged Patient #1 was missing a comprehensive assessment that should have been completed between 4/26/24 to 4/30/24 and failed to have a POC for the certification period for 5/1/24 to 6/29/24. The alternate administrator stated she did not know why Patient #1 was missing this comprehensive assessment and POC. The alternate administrator stated the agency’s EMR was missing documentation so it was possible the reassessment and POC was deleted. The alternate administrator also stated the 6/24/24 comprehensive assessment for Patient #1 completed by RN #3 was done a day early for the 6/30/24 to 8/28/24 certification period, thus failing to meet the regulatory requirement to complete the reassessment in the last 5 days of the 60 day certification period.”

“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 interview and record review the agency failed to have a complete and accurate plan of care (POC) for 2 of 5 active patient records reviewed (Patients #1 and #2). Findings include: AGENCY POLICY According to an undated agency policy titled, Plan of Care Requirements, (read in pertinent parts): “The individualized plan of care must include the following: -All medications, and treatments; -Measurable outcomes, and goals, identified by the agency, and the patient.” 1. During an interview on 6/28/24 at 11:14 a.m., the administrator stated POCs were developed by the clinician who completed the start of care or recertification comprehensive assessment, which typically was a registered nurse (RN) or a physical therapist (PT) if no RN was assigned to provide the patient care. The administrator stated the agency expected the RN/PT to complete their documentation on the comprehensive assessment within 72 hours. The administrator stated if the RN/PT took longer than 72 hours to complete the paperwork a member of the agency management staff would reach out to the clinician to see why the paperwork was not completed. The administrator stated she would review the comprehensive documentation to assess if it was accurate and send it back to the RN/PT to correct if she noted errors. After the RN/PT completed the comprehensive assessment he/she could use the information from the assessment to develop a POC for the patient. The administrator stated she expected the RN/PT to review the POC and ensure the POC was accurate. During continued interview the administrator stated the agency was without a director of nursing (DON) from January 2024 until the alternate administrator was appointed as the alternate administrator and DON on 5/22/24. The administrator stated due to the agency’s lack of staff “things were slipping under the rug.” 2. The clinical record for Patient #1 was reviewed on 6/24/24. The POC for the certification period dated 3/2/24 to 4/30/24 (the last documented POC in Patient #1’s record; Cross Reference G570), signed by Patient #1’s physician on 6/10/24, revealed a start of care date of 11/8/22; diagnoses included type 2 diabetes mellitus, hypertension, hyperlipidemia, anxiety, acute kidney failure, and dyspnea. POC orders included SN visits three times a day for assessment and evaluation, medication management and weekly medication setup. a) The agency failed to ensure Patient #1 had an accurate POC. Specifically, the agency failed to ensure Patient #1’s POC had an accurate Lantus Solostar (a prescription, long-acting, synthetic insulin used to treat high blood sugar in adults and children with diabetes) dose listed. Further review of the POC for the certification period dated 3/2/24 to 4/30/24 revealed Patient #1 was to receive 40 milliliters (ml) of Lantus Solostar subcutaneously at night. Review of Patient #1’s medication profile showed Patient #1 was to receive 40 ml of Lantus Solostar subcutaneously at night. Review of supplemental orders failed to show Patient #1’s Lantus Solostar dose had been changed. Review of Patient #1’s communication notes failed to show Patient #1’s Lantus Solostar dose had been changed. Review of SN notes from 4/1/24 to 4/30/24 showed SNs ( licensed practical nurse (LPN) #5, LPN #11 and RN #3) had administered 50 units of Lantus subcutaneously once per day on the last shift of the day. Review of a text message sent to RN #3 from LPN #5 on 4/19/23 showed LPN #5 documented Patient #1’s Lantus increased to 50 units at bedtime. Review of a picture of the prescription box label in Patient #1’s home for Lantus Solostar, sent to the surveyor by RN #3 on 6/27/24, showed a prescription label which showed a prescription for Lantus Solostar was originally written on 11/6/23 and was last filled on 6/8/24 which instructed Patient #1 to inject 50 units of Lantus Solostar subcutaneously at night. During a home visit on 6/25/24 at 9:15 a.m., Patient #1 confirmed she received SN visits three times a day by the agency and during the last visit of the night the SN administered Lantus Solostar subcutaneously. During a home visit on 6/25/24 at 9:15 a.m., LPN #11 confirmed she provided Patient #1 care three times a day Sunday through Tuesday. LPN #11 stated she administered 50 units of Lantus subcutaneously at night to Patient #1. LPN #11 stated she was not aware Patient #1’s POC for the certification period 3/2/24 to 4/30/24 or her medication profile ordered the SN to administer 40 units of Lantus Solostar subcutaneously on their last visit of the day. LPN #11 stated Patient #1 had been receiving 50 units of Lantus for a long time and she could not remember when her dose changed from 40 units to 50 units. LPN #11 stated it was the RN case managers responsibility to ensure the POC had the accurate medication dosage listed. LPN #11 stated RN #3 was Patient #1’s RN case manager. The survey team was unable to call LPN #5 for an interview as she was out on medical leave during the survey. During an interview on 6/26/24 at 3:50 p.m., RN #3 acknowledged she provided Patient #1 care including administering 50 units of Lantus Solostar subcutaneously during her last visit of the day. RN #3 stated she worked per diem for the agency. RN #3 stated she was taught how to complete the paperwork for comprehensive assessments and POCs by the administrator starting in February 2024. RN #3 stated the administrator accompanied her on a start of care comprehensive assessment visit and a recertification comprehensive visit and walked her through how to complete the paperwork for the comprehensive visits. RN #3 stated she was provided screenshots on how to complete the paperwork for recertifications. During continued interview, RN #3 stated she was unaware Patient #1’s POC for the certification 3/2/24 to 4/30/24 or her medication profile stated Patient #1 was to receive 40 ml of Lantus Solostar at night. RN #3 stated LPN #5 and #11 primarily saw Patient #1 and they would up date her if any of Patient #1’s orders changed. RN #3 remembered LPN #11 informing her Patient #1’s Lantus changed to 50 units at night instead of 40 units at night, but she could not recall when that change occurred. Additionally, RN #3 acknowledged she failed to confirm this change by looking at Patient #1’s orders. During an interview on 6/27/24 at 2:09 p.m., RN #3 stated she had provided Patient #1 care that day and confirmed Patient #1’s prescription for Lantus was for 50 units at night subcutaneously. RN #3 acknowledged she had failed to update Patient #1’s POC to reflect her accurate Lantus dose when she completed Patient #1’s POC for the certification period dated 3/2/24 to 4/30/24. During an interview on 7/2/24 at 9:36 a.m., the alternate administrator reviewed Patient #1’s clinical record and stated per the documented orders Patient #1 was to receive 40 units of Lantus Solorstar subcutaneously during her last shift of the evening. The administrator stated she was unaware LPN #5, LPN #11 or RN #3 had documented from 4/1/24 through 4/30/24 they administered 50 units each day during the last shift of the day. The administrator stated when Patient #1’s Lantus dose changed from 40 units subcutaneously to 50 units subcutaneously, she would have expected the LPN or RN who noticed the change in dosage to call Patient #1’s physician to receive a verbal order for the change or to write an updated medication order if the LPN/RN observed the prescription on the bottle in Patient #1’s home. The alternate administrator stated if either of those orders had been written, the dosage would have been updated on the POC and all subsequent POCs. The alternate administrator acknowledged this did not occur for Patient #1 and she was unsure why. During an interview on 7/2/24 at 2:31 p.m., the administrator was informed by the survey team they had several more questions for her regarding patient specific questions. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions. 3. The clinical record for Patient #2 was reviewed on 6/25/24. The POC for the certification period dated 5/3/24 to 7/1/24 revealed a start of care date of 1/9/23; diagnosis included gastro-esophageal reflux disease, hypertension, bilateral primary osteoarthritis of knee, pain, obesity, and asthma. POC orders included SN visits two times a day five days for 56 to 60 days for assessment, lymphedema management (a chronic condition that causes swelling in the body’s tissues due to a buildup of lymph fluid) and education. a) The agency failed to ensure Patient #2’s POC contained measurable SN goals related to lymphedema management. Review of the clinical record revealed RN #8 completed a recertification comprehensive assessment for Patient #2 on 5/2/24, a transfer to an inpatient facility without an agency discharge on 5/6/24, and a resumption of care comprehensive assessment on 5/10/24. Further review of Patient #2’s POC for the certification period dated 5/3/24 to 7/1/24 showed RN #8 signed the POC on 6/20/24. Review of the POC showed RN #8 documented Patient #2 would receive the following SN interventions: -SN twice a day five day days a week for lymphedema management, first visit of the day to apply low compression wraps to left leg toe to knee in figure 8 form and second visit of the day SN to remove wraps and assess circulation, sensation, and skin integrity a minimum of two hours after application, maximum of 12 hours; -SN to assess and evaluate every 56- 60 days; -instruction/teaching pain levels and management; and -observation and assessment of patient’s need/use of assistive devices. Patient #2’s SN goals were documented as follows: -Patient/caregiver will verbalize understanding of measures to alleviate pain and factors that increase pain within; -Patient with transfer/ambulate and use assistive device safely within as evidenced by lack of falls and/or other problems and verbalization of increased stability and ambulation within. The POC failed to list a SN goal for the lymphedema management/care provided to Patient #2. During a home visit on 6/25/24 at 11:53 a.m., RN #8 acknowledged she was Patient #2’s RN case manager and responsible for developing Patient #2’s POC. RN #8 reviewed Patient #2’s POC from 5/3/24 to 7/1/24 and acknowledged the POC failed to have a SN goal for the lymphedema care RN #8 and other agency SNs provided to Patient #2. RN #8 stated she entered goals into a patient’s comprehensive assessment in the agency’s electronic medical record system and then she would pull information from the comprehensive assessment to the POC to develop the POC. RN #8 stated the SN goal for Patient #2 must have accidentally fallen off of her POC. RN #8 stated she never saw the finished POC for a patient once she developed it. During an interview on 7/2/24 at 9:52 a.m., the alternate administrator reviewed Patient #2’s POC for the certification period dated 5/1/24 to 7/3/24 and acknowledged the POC failed to have a SN goal for lymphedema management. The alternate administrator stated the agency expectation was each SN intervention had a corresponding goal. The alternate administrator stated she did not know why the goal Patient #2 lymphedema management was not on her POC. During an interview on 7/2/24 at 2:31 p.m., the administrator was informed by the survey team they had several more questions for her regarding patient specific questions. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions.”

“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 interview and record review the agency failed to ensure services and treatments were administered by staff only as ordered by a physician in 6 of 7 patients reviewed (Patients #1, #2, #3, #4, #5, and #7). Findings include: AGENCY POLICY: According to the agency policy titled “Plan of Care Requirements” with an unknown dated read in pertinent parts; “Each patient must receive the Home Health Services that are written in an individualized plan of care…The individualized plan of care must include the following; all medications, and treatments”. 1. The clinical record for Patient #1 was reviewed on 6/24/24. The plan of care (POC) for the certification period dated 3/2/24 to 4/30/24 (the last documented POC in Patient #1’s record) revealed a start of care date of 11/8/22; diagnoses included type 2 diabetes mellitus, hypertension, hyperlipidemia, anxiety, acute kidney failure, and dyspnea. POC orders included skilled nursing (SN) visits three times a day for assessment and evaluation, medication management and weekly medication setup. a) The agency failed to have physician orders for all services provided to Patient #1 from 3/2/24 to 4/30/24. Review of Patient #1’s clinical record revealed a request order dated 4/25/24. The order requested SN to continue three times daily for diabetes management and medication management. The order stated it was a late entry for 3/2/24. Further review of the order revealed registered nurse (RN) #3, who filled out the order, signed it on 4/29/24. The order also stated it was a verbal order that was “read back.” The order was never signed by the physician on the order. During an interview on 6/26/24 at 3:50 p.m., RN #3 stated she did not call in any verbal orders to the physician, and agreed the above order was never called into the physician. RN #3 explained the verbal order read back meant it was explained to Patient #1 and the patient agreed with the order. Review of the POC for the certification period 3/2/24 to 4/30/24 revealed it was not signed by the physician until 6/10/24. Since the agency failed to receive verbal orders and the POC was not signed by the physician until after the end of the certification period, all SN services provided for the certification period 3/2/24 to 4/30/24 were done without physician orders. b) The agency failed to ensure SN services, specifically holding insulin, were performed in accordance with physician orders. Review of Patient #1’s clinical record revealed the following information on Patient’s #1 POC dated 3/2/24 to 4/30/24; -HumaLOG Pen Subcutaneous Solution Pen-Injector 100 UNIT/ML - 15 units - TID (three times daily) OnGoing. Review of the SN visit notes written by licensed practical nurse (LPN) #11 from 3/31/24 to 4/30/24 revealed LPN #11 held the HumaLOG insulin injection on the following days; 3/31/24, 4/2/24, 4/14/24, 4/23/24, and 4/29/24. There was no documentation in the SN visit notes that LPN #11 had contacted the physician for orders to hold the medication. During a home visit interview on 6/25/24 at 9:15 a.m., LPN #11 stated the HumaLOG insulin injection was to be held if Patient #1’s blood sugar level was below 100 and the patient had not eaten. LPN #11 was not able to identify the order to hold the HumaLOG in Patient #1’s chart. LPN #11 went on to state she contacted the physician each time she held the HumaLOG but went on to state she may have forgotten to document the phone calls in the notes. During an interview on 7/2/24 at 8:39 a.m., the alternate administrator, reviewed the POC for Patient #1 and agreed there were no orders to hold the HumaLOG insulin injection for any reasons. The alternate administrator also reviewed the SN notes and could not find documentation of the physician being notified that the medication was held for Patient #1. 2. The clinical record for Patient #2 was reviewed on 6/25/24. The POC for the certification period dated 3/4/24 to 5/2/24 revealed a start of care date of 1/9/23; diagnoses included gastro-esophageal reflux, essential (primary) hypertension, pain unspecified and obesity unspecified. POC orders included SN visits twice daily for 5 days per week for lymphedema management to apply low compression wraps. a) The agency failed to have physician orders for all services and treatments provided to Patient #2 from 3/4/24 to 4/24/24. Review of Patient #2’s clinical record revealed a request order written on 4/25/24 by RN #8. The order stated it was a late entry for 3/4/24 and included orders for skilled nursing to continue twice daily for five days per week for lymphedema management. The requested order was not signed by the physician by the end of the survey. Review of Patient #2’s clinical record revealed a plan of care for the certification period 3/4/24 to 5/2/24. The POC was signed by the physician on 4/24/24. Since the agency had no verbal orders until 4/25/24, and the POC was not signed by a physician until 4/24/24, all services and treatments provided to Patient #2 between 3/4/24 and 4/24/24 were done without physician orders. During an interview on 6/25/24 at 3:58 p.m., RN #8 stated she thought she called Patient #2’s physician for a verbal order for the recertification, but had forgotten to document this verbal order. RN #8 could not recall who she specifically spoke with at Patient #2’s physicians office to obtain the recertification order for the POC period which began on 3/4/24. RN #8 went on to state this was her mistake and she should have done better. RN #8 also stated she struggled with the computer system and getting paperwork done. During an interview on 7/2/24 at 8:39 a.m., the alternate administrator, reviewed the POC for Patient #2 and agreed there were no verbal orders to continue care for Patient #2. 3. The clinical record for Patient #4 was reviewed on 6/26/24. The POC for the certification period dated 6/5/24 to 8/3/24 revealed a start of care date of 2/16/22; diagnoses included essential primary hypertension, hidradenitis suppurativa, and gastro-esophageal reflux disease without esophagitis. POC orders included SN visits twice a week for nine weeks for skilled assessment and wound care. a) The agency failed to have physician orders for wound care provided to Patient #4. Review of the Patient #4’s verbal order dated 6/4/24 written by RN #9 (who resigned her position with the agency during the survey on 6/25/24) stated the frequency for SN twice a week for nine weeks, and wound care. It did not describe what the wound care was supposed to entail. There was also no documentation of the wound location, or how many wounds Patient #4 had. Review of Patient #4’s POC revealed the exact same order as what was written in the verbal order. Review of Patient #4’s SN visit notes revealed LPN #11 performed the following wound care on 6/25/24 and 6/23/24; -Cleanse with Antiseptic Applied Silver alginate to the wound bed, covered with gauze and secured with tape. -Multiple small open areas bilateral groin, as well as lesion on labia. Cleansed with Antiseptic. Packed lesion with iodoform. Silver alginate to other areas. During an interview on 7/2/24 at 12:26 p.m., LPN #11 stated Patient #4’s wounds vary from time to time and these wounds would pop up randomly. LPN #11 went on to state the current number of wounds were two. LPN #11 also stated she had just received new wound care orders on 6/29/24 but may not have put them into the patient’s chart yet. LPN #11 also stated prior to the 6/29/24, the wound care orders were for silver alginate and pack the internal wound with iodoform. LPN #11 also reviewed Patient #4’s chart and agreed the old wound care orders were not on the POC or written on the verbal orders. During an interview on 7/2/24 at 10:09 a.m., the alternate administrator reviewed the record for Patient #4 and agreed she could not find any wound care orders. The alternate administrator went on to state, the last orders for wound care were put into Patient #4’s chart on 6/6/23 or about one year ago. The alternate administrator agreed there was no wound care for SN visits to follow. 4. Similar findings were found for Patients #3, #5, and #7.”

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on interview and record review the agency failed to ensure the individualized plan of care (POC) was reviewed and revised by the physician once every 60 days beginning with the start of care date for 3 of 7 patient records reviewed (Patients #1, #5 and #7). This deficiency was cited previously during a federal complaint survey 3/15/22. Although the agency corrected the deficiency, based on the findings below, the agency has not maintained compliance with this regulatory requirement. Findings include: 1. The clinical record for Patient #1 was reviewed on 6/24/24. The plan of care (POC) for the certification period dated 3/2/24 to 4/30/24 (the last documented POC in Patient #1’s record) revealed a start of care date of 11/8/22; diagnoses included type 2 diabetes mellitus, hypertension, hyperlipidemia, anxiety, acute kidney failure, and dyspnea. POC orders included skilled nursing (SN) visits three times a day for assessment and evaluation, medication management and weekly medication setup. a) The agency failed to ensure Patient #1’s POC was reviewed and revised by the physician every 60 days. Review of the POC for the certification period 3/2/24 to 4/30/24 revealed it was signed by registered nurse (RN) #3 on 4/29/24, one day before the end of the certification period. Further review of the POC revealed it was signed by the physician on 6/10/24, 42 days after when it was supposed to be reviewed and signed by Patient #1’s physician. During an interview on 6/26/24 at 3:50 p.m., RN #3 stated she had only learned a few weeks earlier how to create a POC. RN #3 stated she was taught to go into the agency’s electronic medical record (EMR) system, add the order and then send the POC to be checked by quality assurance. RN #3 stated previously before being taught how to do it, the administrator of the agency would send her a message to do it. RN #3 went on to state the reason for the creation of the POC was so late because she did not know how to do it before then, and that she did not know she was supposed to create a POC. During an interview on 6/27/24 at 12:31 p.m., the non-skilled alternate agency manager stated she had faxed out the POC to be signed by the physician on 5/2/24, two days after it was supposed to be reviewed and signed by the physician of Patient #1. The non-skilled alternate agency manager could not explain why it was faxed out late, stating it was sent out when it was approved to be sent out by the administrator. During an interview on 7/2/24 at 1:58 p.m., the administrator stated it was missed because there was so much on her plate as she did not have enough staff to cover everything. 2. The clinical record for Patient #5 was reviewed on 6/25/24. The POC for the certification periods dated 2/1/24 to 3/31/24, 4/1/24 to 5/30/24 and 5/31/24 to 7/29/24 revealed a start of care date of 12/19/22; diagnoses included stage 4 chronic kidney disease, hypercalcemia, anemia, osteoarthritis, glaucoma,and disorder of thyroid. POC orders included certified nursing assistant (CNA) visits two times daily for assistance with activities of daily living (ADLs) and instrumental ADLs (complex tasks people do daily to take care of themselves and their homes such as managing finances, taking medication and preparing food). a) The agency failed to ensure Patient #5’s POC was reviewed and revised by the physician every 60 days. Review of the POC for the certification period 4/1/24 to 5/30/24 revealed it was signed by RN #9 (who resigned her position with the agency during the survey on 6/25/24) on 6/11/24, 11 days after the end of the certification period. Further review of the POC revealed the POC had still not been signed by the physician on 6/25/24, 25 days after when it was supposed to be reviewed and signed by Patient #5’s physician. During an interview on 7/2/24 at 10:09 a.m., the alternate administrator reviewed the record for Patient #5 and agreed the POC for the period of 4/1/24 to 5/30/24 had not yet been signed by the physician and it was late. 3. The clinical record for Patient #7 was reviewed on 6/24/24. The POC for the certification periods dated 1/26/24 to 3/25/24, 3/26/24 to 5/24/24 and 5/25/24 to 7/23/24 revealed a start of care date of 11/27/23; diagnoses included iron deficiency anemia, unspecified protein-calorie malnutrition and hypokalemia. POC orders included SN visits once weekly and as needed visits (PRN) to change colostomy bag, and troubleshoot when the patient has problems with the bag. a) The agency failed to ensure Patient #7’s POC was reviewed and revised by the physician every 60 days. Review of the POC for the certification period 1/26/24 to 3/25/24 revealed it was signed by RN #8 on 4/2/24, eight days after the end of the certification period. Further review of the POC revealed the POC was not signed by the physician until 4/9/24, 15 days after when it was supposed to be reviewed and signed by Patient #7’s physician. During an interview on 6/26/24 at 11:04 a.m., RN #8 stated she had never met Patient #7 and had certainly not created a POC for her. RN #8 was unable to explain why the POC for the certification period 1/26/24 to 3/25/24 was signed late as she again stated she had never met Patient #7. During an interview on 6/27/24 at 2:52 p.m., the alternate administrator was not able to explain why the POC was not reviewed and signed by the physician until 15 days after the end of the certification period. The alternate administrator agreed the POC for the certification period 1/26/24 to 3/25/24 was not reviewed or revised by the physician every 60 days.”

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure clinical records contained accurate documentation of pertinent past and current findings in accordance with accepted professional standards for 1 of 5 active patients records reviewed (Patient #2). Findings include 1. The clinical record for Patient #2 was reviewed on 6/25/24. The plan of care (POC) for the certification period dated 5/3/24 to 7/1/24 revealed a start of care date of 1/9/23; diagnosis included gastro-esophageal reflux disease, hypertension, bilateral primary osteoarthritis of knee, pain, obesity, and asthma. POC orders included skilled nursing (SN) visits two times a day five days for 56 to 60 days for assessment, lymphedema management (a chronic condition that causes swelling in the body’s tissues due to a buildup of lymph fluid) and education. a) The agency failed to ensure the registered nurse (RN) documented the application and removal of lymphedema wraps correctly. Review of the POC from the certification period 5/3/24 to 7/1/24 revealed SN were to apply low compression wraps to the left leg toe to knee in figure 8 form, and to remove wraps and assess circulation, sensation and skin integrity a minimum of of two hours after application with a maximum of 12 hours. Record review of SN visit notes from 5/3/24 to 6/25/24 revealed RN #9 (who resigned her position with the agency during the survey on 6/25/24) documented contradictory information in two different sections of the SN visit notes. In the intervention note section of the SN note RN #9 documents she removed wraps from left knee to left toes, and in the general notes sections RN #9 documented she applied the wraps to the left lower leg in the same note. The following visits were visits in which RN #9 was to apply the wraps but within the visit notes it stated the wraps were both applied and removed; 6/24/24, 6/21/24, 6/19/24, 6/17/24, 6/12/24, 6/10/24, 6/7/24, 6/5/24, 5/31/24, 5/29/24, 5/27/24 and 5/22/24. Further review of the SN visit notes revealed RN #9 also noted in the intervention she applied the wraps but in the general notes the wraps were removed during the same visit. The following visits were visits in which RN #9 was to remove the wraps but within the visit notes it states the wraps were both applied and removed; 6/14/24, 5/3/24, 5/24/24, and 5/20/24. The survey team attempted to interview RN #9 at 11:00 a.m. on 6/26/24, but was unable to reach RN #9, thus a message was left requesting a call back. On 6/26/24 at 11:48 a.m., the survey team received a text message from RN #9 informing the survey team RN #9 no longer worked for the agency. The non-skilled agency manager informed the survey team on 6/26/24 at 11:45 a.m. RN #9 resigned her position as RN case manager at 5 p.m. on 6/25/24. Record review of the the SN visit notes from 5/3/24 to 6/25/24 revealed RN #8 documented she applied the wraps during visits where the wraps were to be removed. This happened on the following days; 6/9/24, 6/6/24, 5/23/24, 5/18/24, 5/16/24m 5/12/24 and 5/11/24. During an interview on 6/26/24 at 11:58 a.m., RN #8 stated the EMR system pulled over previous notes, and RN #8 would have to edit them to make sure they were correct. to try to avoid having conflicting information in her note. RN #8 also stated she tried to audit Patient #2’s notes, and could not believe she missed that many errors. During an interview on 6/26/24 at 11:47 a.m., the alternate administrator stated the intervention notes section of the SN notes were autofilled by the electronic medical record (EMR) system with the type of intervention to be done with the patient. The alternate administrator stated she didn’t realize t nurses were documenting in the intervention notes section. The alternate administrator stated SN should document comments about their visit in the general notes section of the note. The alternate administrator stated the intervention notes should be the intervention information from the POC, and not what intervention was completed on the visit. The alternate administrator agreed the intervention notes for RNs #8 and #9 did not match.”

“Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This Element is not met as evidenced by: Based on interview and record review, the agency failed to ensure a supervising registered nurse (RN) provided consistent and appropriate day-to-day oversight and supervision of licensed practical nurses (LPN) providing patient care for 2 of 7 patient records reviewed (Patients #4 and #7). Findings include: AGENCY POLICY According to an undated agency policy titled, Clinical Supervision, (read in pertinent parts): “Each clinical staff member, including members that have been contracted, on an individual basis, must be supervised on-site, periodically, by an appropriate supervisor.” “Patients, who are receiving LPN visits are supervised, at least, every 60 days, by a Registered Nurse. Supervision visits are conducted for each patient who is being serviced by the LPN. The LPN is not present during the supervisory visit.” 1. During an interview on 6/27/24 at 2:52 p.m., the non-skilled agency manager stated she was aware the agency’s EMR system was inaccurately assigning patients to RN case managers after the EMR had a software update. The non-skilled agency manager stated RN #8 called the administrator to complain about being assigned to at least three patients she was not overseeing. The non-skilled agency manager stated the administrator had called the agency’s EMR company to attempt to get the issue resolved and had removed RN #8 as the assigned case manager for the three patients RN #8 stated she was not following. The non-skilled manager stated she did not know how a digital signature could be applied to the system without the clinician’s password. The non-skilled agency manager stated she had never assigned RN #3 to complete a recertification comprehensive assessment for Patient #5, but acknowledged she had assigned RN #9 to complete the 6/10/24 recertification comprehensive assessment for Patient #5. During an interview on 6/28/24 at 1:05 a.m., the non-skilled agency manager and the agency’s human resource manager stated they could not provide the survey team with any documentation on why nurses names were appearing digitally signed on assessments the RN stated they did not complete. During an interview on 6/28/24 at 11:47 a.m., the administrator stated she did not know how clinician’s digital signatures were appearing on assessments the clinician and patient denied were completed by the clinician. The administrator stated no employee could digitally sign for another employee without having the clinicians password. During an interview on 7/1/24 at 9:08 a.m., a representative for the agency’s EMR company stated a clinician’s digital signature was unique to each user and in order to insert a digital signature on a document the person inserting the signature would need the clinician’s username and password. The representative for the agency’s EMR company stated there were three ways she could think of how another person might be able to insert a clinician’s digital signature on a document: the clinician provided their username and password to the person inserting the digital signature; the person inserting the digital signature was using a device where the clinician’s username and password was stored on the device; or the person inserting the digital signature had reset the clinician’s password. During an interview on 7/2/24 at 2;27 p.m., the administrator stated RN #3 was trained how to do start of care and recertification comprehensive assessments on her date of hire (1/4/23). The administrator stated RN #3 worked per diem (as needed) for the agency and requested a retraining on how to complete start of care and recertification comprehensive assessments in February 2024, and the administrator accompanied RN #3 on a few visits in February 2024 to provide this training. 2. The clinical record for Patient #7 was reviewed on 6/24/24. The plan of care (POC) for the certification period dated 11/27/23 to 1/25/24, signed by Patient #7’s physician on 1/2/24, revealed a start of care date of 11/27/23; diagnosis included iron deficiency anemia, protein-calorie malnutrition, hypokalemia and toxic megacolon. POC orders included physical therapy (PT) to assess, evaluate and treat. Review of the POCs for the certification periods dated 1/26/24 to 3/25/24, signed by Patient #7’s physician on 4/9/24, and 3/26/24 to 5/24/24 signed by Patient #7’s physician on 4/9/24, revealed a start of care date of 11/27/23; diagnosis included iron deficiency anemia, protein-calorie malnutrition, hypokalemia and toxic megacolon. POC orders included skilled nursing (SN) visits one time a week and as needed (PRN) assessment and evaluation, education and colostomy (a small, waterproof pouch that collects stool from the digestive tract through an opening in the abdominal wall) care. a) The agency failed to ensure a RN provided supervision of Patient #7’s care. Specifically, a RN failed to provide an assessment prior to LPNs providing care to Patient #7. Review of agency documentation showed the agency received referral documentation for Patient #7 on 11/17/23 from a skilled nurse facility (SNF) nurse practitioner (NP) who ordered PT upon Patient #7’s discharge to her assisted living residence (ALR) on 11/18/23. Review of the clinical record revealed PT #4 completed a comprehensive assessment with Patient #7 on 11/27/23, 10 days after Patient #7 discharged from the SNF. Cross Reference G514 Review of the clinical record revealed RN #8 digitally signed a comprehensive assessment for Patient #7 on 4/2/24 at 12:44 p.m. for a comprehensive assessment completed on 1/25/24. This comprehensive assessment failed to have a documented start or stop time for the visit and the patient signature section had a handwritten note which stated “tablet issues” timestamped 4/2/24 at 12:43 p.m. Review of the clinical record revealed RN #8 digitally signed a comprehensive assessment for Patient #7 on 4/2/24 at 12:35 p.m. for a comprehensive assessment completed on 3/21/24. This comprehensive assessment failed to have a documented start or stop time for the visit and the patient signature section had a handwritten note which stated “tablet issues” timestamped 4/2/24 at 12:35 p.m. Review of supplemental orders from 11/27/23 through 6/24/24 showed on 4/29/24 RN #3 signed and documented a late entry request order on 4/25/24 at 13:20 p.m. effective 11/27/23 for admission to SN once weekly and PRN for colostomy care and management. This order was signed by Patient #7’s physician on 5/3/24. Further review of supplemental orders showed on 1/25/24, no timestamp provided, RN #3 digitally signed a request order documented on 1/25/24 at 12:47 p.m. stating recertification was completed and requesting orders for continued SN one time a week and PRN for colostomy care and issues with colostomy care. This order was signed by Patient #7’s physician on 4/10/24. Further review of supplemental orders showed on 3/26/24, no timestamp provided, RN #3 digitally signed a request order documented on 3/26/24 at 12:49 p.m. stating recertification was completed and requesting orders for continued SN one time a week and PRN for colostomy care and issues with colostomy care. This order was signed by Patient #7’s physician on 5/1/24. Review of Patient #7’s schedule calendar from November 2023 through April 13, 2024 showed Patient #7 was seen by the following SNs: -LPN #5 twenty one times on the following days: 12/1/23, 12/8/23, 12/15/23, 12/29/23, 1/5/24,1/11/24, 1/19/24, 1/26/24, 1/31/24, 2/9/24, 2/16/24, 2/23/24, 3/1/24, 3/8/24, 3/9/24, 3/13/24, 3/15/24, 3/20/24, 3/22/24, 3/28/24, 3/29/24; -LPN #11 eight times on the following days 12/22/23, 1/15/24, 2/6/24, 2/27/24, 3/11/24, 3/12/24, 4/1/24, 4/9/24; -RN #3 three times on 1/25/24 and two times on 4/13/24; and -RN #8 one time on 3/21/24. Review of SN notes from 11/27/23 through 4/13/23 showed LPN #5 documented she provided Patient #7 with 21 visits; LPN #11 documented she provided Patient #7 with eight visits and RN #3 documented she provided Patient #7 with two visits. Documentation review showed Patient #7 received her first RN visit on 1/25/24 by RN #8 for a comprehensive assessment that failed to have Patient #7’s signature, failed to have a time the visit was started or stopped, and was scheduled on Patient #7’s calendar to be completed by RN #3. Prior to this comprehensive assessment, Patient #7 had nine LPN visits completed by LPNs #5 and #11 without RN oversight. Patient #7 received her second RN visit on 3/21/24 for a comprehensive assessment documented by RN #8 and scheduled to be completed by RN #8, however, the visit failed to have a start and stop time and was not signed by Patient #7. Between 1/25/24 to 3/21/24, Patient #7 received 15 LPN visits from either LPN #5 or LPN #11. Patient #7 received 5 LPN visits from either LPN #5 or #11 between her 3/21/24 comprehensive assessment and a RN #3 providing her with two SN visits on 4/13/24. During an interview on 6/26/24 at 3:50 p.m., RN #3 acknowledged she had provided Patient #7 care and acknowledged she provided Patient #7 with care two times on 4/13/24. RN #3 stated she could not recall what day she first provided Patient #7, but she was sure she had not met her or provided her care in January of 2024. RN #3 stated she worked per diem for the agency and learned on 2/13/24 from the agency administrator how to complete a comprehensive assessment for a patient. RN #3 stated she did not complete the comprehensive assessment for Patient #3 on 1/25/24 as documented on Patient #7’s schedule calendar. During continued interview, RN #3 stated she recently learned how to enter orders into the agency’s electronic medical record (EMR) system. RN #3 stated although the orders were labeled verbal orders, this was inaccurate as she had never called a physician for any patients she had cared for at the agency to obtain a verbal order for care. RN #3 stated agency management sent her several orders to correct as she had not clicked the “read back” box on the order. RN #3 stated she informed the “office” she did not click the “read back” button on the order as she had not called a physician to obtain a verbal order on any of the orders. One of the office staff (RN #3 could not specially recall who in the office) informed RN #3, the “read back” on the order meant the patient agreed to the order. RN #3 felt this information was inaccurate as at her other SN jobs marking “read back” meant the order had been read back by the person receiving the order at the requesting physician office, but complied with instructions provided by the agency office staff and checked the “read back” button on all the orders returned to her. During continued interview, RN #3 acknowledged it was her signature on the order dated 4/25/24 for a late entry of 11/27/23. RN #3 stated she did not write the order as she would never write an order almost 5 months after the date, but stated the order most likely was included in stack of orders sent to her by either the administrator or LPN #5 (who RN #3 stated was helping the office with chart audits) to sign. RN #3 acknowledged she failed to read all of the orders signed prior to signing them. During an interview on 6/26/25 at 11:58 a.m., RN #8 stated she had never met Patient #7 nor had she completed the comprehensive assessment for Patient #7 on 1/25/24 or 3/21/24. RN #8 stated she signed her documents and did not digitally sign any documentation. RN #8 stated she was not sure she even knew how to digitally sign documents in the EMR. During an interview on 6/27/24 at 3:15 p.m., the alternate administrator reviewed Patient #7’s record and acknowledged Patient #7 received nine visits total provided by LPNs #5 and #11 between 12/1/23 and 1/24/24 and Patient #7’s first documented RN visit was on 1/25/24 for the comprehensive visit documented as completed by RN #8, scheduled as completed by RN #3 and had a corresponding late entry order documented by RN #3. The alternate administrator stated she did not know why Patient #7 was not assessed first by an RN as agency policy and regulation required as this was before she became the alternate administrator and director of nursing for the agency (appointed on 5/22/24). The alternate administrator stated she could not explain why the 1/25/24 and 3/21/24 comprehensive assessments were digitally signed by RN #8 who stated she had never met Patient #7. The alternate administrator also stated she could not explain why Patient #7’s calendar stated RN #3 provided the 1/25/24 RN visit when RN #3 stated she had not met Patient #7 in January nor did she know how to complete the paperwork for a comprehensive assessment until 2/13/24. During continued interview, the administrator acknowledged the agency failed to ensure a RN provided an initial assessment of Patient #7 prior to LPN #5 providing a visit to Patient #7 on 12/1/23 or prior to the eight other visits provided between LPNs #5 and #11 from 12/8/23 through 1/19/24. The failure to have RN oversight for Patient #7 from 12/1/23 through 1/24/24 the administrator stated this was an oversight on the agency’s part. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions. 3. The clinical record for Patient #4 was reviewed on 6/26/24. The POC for the certification period dated 2/6/24 to 4/5/24, revealed a start of care date of 2/16/22; diagnosis included hypertension, hidradenitis suppurativa (a chronic skin condition that causes painful lumps to form where your skin rubs together, typically in the armpit and/or groin), gastro-esophageal reflux and external surgical wound. POC orders included SN visits two times a week for 60 days to provide assessment, education, medication compliance and wound care as ordered by the physician. Review of the POC for the certification period dated 4/6/24 to 6/4/24 and 6/5/24 to 8/3/24, revealed a start of care date of 2/16/22; diagnosis included hypertension, hidradenitis suppurativa, and gastro-esophageal reflux. POC orders included SN visits two times a week for 60 days to provide assessment, education, medication compliance and wound care as ordered by the physician. Review of the POC for the certification periods dated 6/5/24 to 8/3/24, revealed a start of care date of 2/16/22; diagnosis included hypertension, hidradenitis suppurativa, and gastro-esophageal reflux. POC orders included SN visits two times a week for nine weeks to provide assessment and wound care as ordered by the physician. Review of the recertification comprehensive assessment completed on 2/5/24 with no start or stop time for the visit documented, digitally signed by RN #3 on 2/6/24 at 11:27 a.m., not signed by Patient #4 with a handwritten note in the patient signature line stating “tablet issues” timestamped 2/6/24 at 11:27 a.m. showed documentation in the summary and notes section which stated “Patient wound at this time is unmeasurable[,] but just not healed at this time.” The wound section of the recertification comprehensive assessment showed documentation of a surgical pubic wound with no edema present, healthy wound bed tissue and surrounding tissue normal for ethnic group. No further documentation of the number of wounds, size of the wounds or the wound characteristics was documented. Review of the recertification comprehensive assessment completed on 4/5/24 with no start or stop time for the visit documented, signed by RN #3 on 5/5/24 at 9:40 p.m., signed by Patient #4 on 4/10/24 at 12:19 p.m. showed documentation in the summary and notes section which stated “Patient wound at this time is unmeasurable[,] but just not healed at this time.” The wound section of the recertification comprehensive assessment showed documentation of a surgical pubic wound with no edema present, healthy wound bed tissue and surrounding tissue normal for ethnic group. No further documentation of the number of wounds, size of the wounds or the wound characteristics was documented. Review of the certification comprehensive assessment completed on 6/5/24 with no start or stop for the visit documented, signed by RN #9 on 6/9/24 at 7:45 p.m. and not signed by Patient #7 with a handwritten note in the patient signature line stating “late entry” timestamped 6/9/24 at 7:45 p.m. showed showed documentation in the summary and notes section which stated “Patient wound at this time is unmeasurable[,] but just not healed at this time.” The wound section of the recertification comprehensive assessment showed documentation of a surgical pubic wound with no edema present, healthy wound bed tissue and surrounding tissue normal for ethnic group. No further documentation of the number of wounds, size of the wounds or the wound characteristics was documented. Review of SN notes from 5/3/24 through 6/25/24 showed LPN #5 documented she provided Patient #4 with care five times (5/3/24, 5/6/24, 5/10/24, 5/17/24, and 5/24/24) and LPN #11 documented she provided Patient #4 with care 10 times (5/13/24, 5/20/24, 5/28/24, 6/3/24, 6/9/24, 6/11/24, 6/16/24, 6/18/24, 6/23/24, and 6/25/24). Review of SN notes failed to show Patient #4 had received any visits from agency RNs between 5/3/24 and 6/25/24. During an interview on 6/27/24 at 10:56 a.m., Patient #4 acknowledged she received care from LPNs #5 and #11 two times a week for wound care. Patient #4 stated she received recertification assessments from agency RNs approximately one time a year. Patient #4 stated the last visit from an agency RN for recertification she could remember was in April or May of 2024 and the nurse who provided the visit drove a red car (she could not remember the RN’s name. RN #3 confirmed in an interview on 6/27/24 at 11:36 a.m. that she drove a red car). Patient #4 denied seeing an agency RN for a recertification assessment in June of 2024. Patient #4 stated the agency called to ask if an RN could come out to assess her in June of 2024 and she declined the visit as she was specific about who she let work with her. The survey team was unable to interview LPN #5 as she was on medical leave. During an interview on 7/2/24 at 12:26 p.m., LPN #11 acknowledged she provided wound care to Patient #4 two times a week. LPN #11 stated Patient #4 would only let LPN #5 or LPN #11 observe and treat her wounds. LPN #11 stated RN #9 had never met or completed a recertification assessment with Patient #4. LPN #11 stated she was 100% certain RN #3 was the last agency RN to come complete a recertification assessment with Patient #4. The survey team attempted to interview RN #9 at 11:00 a.m. on 6/26/24, but was unable to reach RN #9, thus a message was left requesting a call back. On 6/26/24 at 11:48 a.m., the survey team received a text message from RN #9 informing the survey team RN #9 no longer worked for the agency. The non-skilled agency manager informed the survey team on 6/26/24 at 11:45 a.m. RN #9 resigned her position as RN case manager at 5 p.m. on 6/25/24. During an interview on 6/26/24 at 3:50 p.m., RN #3 stated she worked per diem for the agency and learned on 2/13/24 from the agency administrator how to complete a comprehensive assessment for a patient. RN #3 stated when the administrator educated her in February 2024 how to complete a comprehensive assessment, the administrator told her it was important for RN #3 to complete the assessment on the day the agency scheduled her to complete the assessment as the assessment date had to align appropriately with the corresponding certification window. RN #3 stated, the administrator also informed RN #3 if she could not complete the assessment on the day assigned to make sure she documented the assessment was completed on the assigned date to not throw the assessment date off from the corresponding certification period. During continued interview, RN #3 acknowledged she had completed the recertification comprehensive for Patient #4 in April 2024. RN #3 stated she could not recall the specific date she completed the assessment, but she would not have gone back to have Patient #4 sign the comprehensive assessment so she assumed she completed the recertification comprehensive assessment on 4/10/24 the day Patient #4 signed the comprehensive assessment, not on 4/5/24, the day the recertification comprehensive assessment was documented as completed. RN #3 stated Patient #4 was particular about who she would let assess and treat her wounds and RN #3 was unable to assess Patient #4’s wounds during the recertification comprehensive assessment. RN #3 denied completing the 2/5/24 recertification comprehensive assessment as she stated she did not know how to complete the paperwork for a comprehensive assessment until 2/13/24. Additionally, RN #3 stated she always signed her assessments and was not aware documents could be digitally signed in the agency’s EMR. RN #3 stated she did not know how her digital signature was placed on the 2/5/24 recertification comprehensive assessment for Patient #4. During an interview on 7/2/24 at 10:35 a.m., the alternate administrator acknowledged a patient had a right to refuse to let a specific clinician assess a wound, but agreed the agency was responsible for ensuring the wound was assessed by an RN. During an interview on 7/2/24 at 2;27 p.m., the survey team attempted to ask the administrator patient specific questions including why the agency failed to ensure and RN provided oversight for the wound care provided to Patient #4. The administrator stated she did not have any more time to answer the surveyors questions and to use the alternate administrator’s answers to patient specific questions.”