Every finding on record at Colorado Plains Home Health LLC

A recertification survey was completed on 12/16/21. Investigation findings revealed the agency had failed to ensure patients rights were upheld regarding discharge planning, patient's received services in accordance with physician orders and only as ordered by a physician, failed to develop and maintain an appropriate Quality Assurance Performance Improvement (QAPI) program, and failed to employ qualified administrative staff to ensure all day to day activities of the agency were completed appropriately and in accordance with regulation. The following Conditions of Participation were out of compliance: -484.50 PATIENT RIGHTS; -484.60 CARE PLANNING, COORDINATION, QUALITY OF CARE; -484.65 QUALITY ASSURANCE PERFORMANCE IMPROVEMENT; and -484.105 ORGANIZATION AND ADMINISTRATION OF SERVICES Additionally, 9 standard level deficiencies were cited. Refer to CFR 484.80(f)(3) guidelines. An agency, which has a Condition of Participation out of compliance with any of the requirements, is precluded from conducting (if approved) or applying to conduct a Nurse Aide Training Program or Competency evaluation for two (2) years from the exit date.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on interviews, clinical record reviews and the nature of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation 484.50 PATIENT RIGHTS, was out of compliance. The deficient practice illustrated systemic process failures that had the potential to affect all patients cared for by the agency. Interview and record review revealed the administrator failed to protect the rights of the patients served by the agency regarding discharge notification and failed to follow regulations for safe transition of care for patients currently served by the agency. Additionally, the agency had not provided patients with a formal notice of discharge by the exit of the survey. This failure created the potential for 41 skilled patients to be without care for an unknown length of time. The following standard level deficiencies were also cited: G464 - Standard: Advise the patient of discharge for cause. The agency failed to independently and autonomously provide verbal and written notice to all current patients of the agency's intent to cease operations. G468 - Standard: Provide contact information to other services. The agency failed to independently and autonomously provide assistance to current patients to make contact with other home health agencies and provide assistance to transfer services to alternative care.

Advise the patient of discharge for cause CFR(s): 484.50(d)(5)(i) (i) Advise the patient, representative (if any), the physician(s) or allowed practitioner(s), issuing orders for the home health plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause is being considered; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to document evidence the agency advised the patients, their representatives and the physicians that a discharge for cause was being considered in 4 of 5 current patient records reviewed (Patients #1, #2, #4 and #5). Findings include: AGENCY POLICY According to the policy, "Agency Organizational Guidelines," reviewed 7/9/19 (in part): "Dissolution of Agency In the event of dissolution of the Agency, we will assure continuity of consumer care by adhering to consumer transfer or discharge notifications as follows: Except in an emergency, the Agency will notify the consumer of the consumer's parent, family, spouse, significant other or legal representative and the consumer's attending physician (if applicable) seven (7) days before the consumer will be transferred or discharged. 1. The consumer will be notified of the Agency's dissolution. 2. The notification will be documented. 3. Agency closure will comply with Colorado Agency Closure Procedures." According to the policy, "Transfer of Care," reviewed 7/9/19 (in part): "A contingency plan will be followed in the event of dissolution of the Agency to assure continuity of consumer care, assure the notification of consumers of the agency's dissolution and documentation of the notification and compliance with State procedures. In the event of Permanent Closure or Voluntary Suspension a. Each consumer or consumer's parent, family, spouse, significant other or legal representative will be notified in writing of the Agency closure and transfer. b. Each consumer's attending physician or practitioner will be notified of Agency closure in writing no later than five (5) days before the date on which the consumer will be transferred or discharged. The Agency will deliver the required notices by hand or mailed at least eight working days before the date of discharge or transfer. c. An agency member will speak with each consumer by telephone or in person to insure the consumer's knowledge of the transfer at least five (5) days before the date of transfer or discharge." 1. During an interview on 12/13/21 at 1:43 p.m., registered nurse clinical manager (RN #2) stated she wasn't sure if the state agency knew of the agency's intent to close. She stated she believed the current patients should receive a 30 day discharge notice with additional agencies to switch to, but was unsure if that notice had been drafted and distributed by the administrator yet. During an additional interview at 2:12 p.m., the administrator stated it didn't look like the agency could continue operating and he had directed the agency to stop accepting new patients two weeks ago. He stated the agency had hired a consultant to help navigate the agency through the process. The administrator further stated the agency had provided a closure notice to the Department with the intended closure date of 12/31/21. He stated the agency was in the middle of providing notices to all patients. He stated some patients had been notified, but the agency was working to provide a written formal notice to all patients regarding the agency's intent to close. 2. Review of documentation provided to the State Agency (SA) on 12/13/21 revealed the agency submitted a letter of intent to cease agency operations and close the agency effective 12/31/21. 3. The clinical record for Patient #2 was reviewed on 12/14/21. The plan of care for the certification period dated 9/10/21 to 11/8/21 revealed a start of care date of 1/13/21; diagnoses included heredity spastic paraplegia, chronic obstructive pulmonary disease (COPD), gastrointestinal hemorrhage, malignant neoplasm of bladder, and stage II pressure ulcers of bilateral buttock. Plan of care orders included skilled nurse (SN) visits once weekly for eight weeks and two visits as needed (PRN) for acute issues or catheter problems and to change catheter every two weeks and certified nurse aide (CNA) visit once weekly for one week then three times weekly for eight weeks for assistance with personal care and activities of daily living (ADLs). An updated plan of care dated 10/13/21 following a hospitalization for the certification period dated 9/10/21 to 11/8/21 included orders for SN visits once weekly for four weeks and two visits PRN for acute issues or catheter problems and to change catheter every two weeks and CNA visits twice weekly for one week, three times weekly for three weeks, then once weekly for one week for assistance with personal care and ADLs. Subsequent plan of care orders for the certification period dated 11/9/21 to 1/7/22 included SN visits once weekly for nine weeks and two visits PRN for acute issues or catheter problems and to change catheter every two weeks and CNA visits twice weekly for one week the three times weekly for eight weeks for assistance with personal care and ADLs. a) The agency failed to independently and autonomously initiate and implement appropriate discharge planning and maintain documentation of communication with patients and coordination with physicians to notify them a discharge for cause was being considered. Clinical review of Patient #2's record revealed Patient #2 required catheter changes every two weeks due to his diagnosis of malignant neoplasm of bladder, total assistance with all personal care tasks, and total assistance with transfers using a mechanical lift, which required the use of two people to ensure the patient's safety. Further review of Patient #2's record failed to reveal any documentation of communication with the patient and documentation of coordination with Patient #2's physician to notify them a discharge for cause was being considered. During a home visit on 12/15/21 beginning at 8:00 a.m., Patient #2 stated he was made aware of the agency's closure by his physician following the agency notifying his physician last week. He stated he had not received verbal or written notification about the agency's intent to close by any agency staff. 4. The clinical record for Patient #1 was reviewed on 12/14/2021. The plan of care for the certification period dated 12/2/21 to 1/30/22 revealed a start of care date of 11/4/15; diagnoses included diabetes, hypertension, and schizophrenia. Plan of care orders included SN visits once weekly for eight weeks to perform a complete physical assessment with emphasis on diabetes and medication management. SN tasks also included the prefilling of insulin syringes and pillbox, per the medication profile. a) The agency failed to independently and autonomously initiate and implement appropriate discharge planning and maintain documentation of communication with patients and coordination with physicians to notify them a discharge for cause was being considered. Clinical review of Patient #1's record revealed Patient #1 required weekly medication management. Specifically, Patient #1 required SN services to pre-fill syringes with insulin and pre-fill his medication box as Patient #1 lacked the cognitive ability due to his mental illness to do so safely and independently. Further review of Patient #1's record failed to reveal any documentation of communication with the patient, and failed to reveal documentation of coordination with Patient #1's physician to notify them a discharge for cause was being considered. During a home visit on 12/14/21 beginning at 11:00 a.m., Patient #1 was asked by the surveyor if he was aware the agency was closing. Patient #1 stated he had not been notified, either verbally or in writing, of the agency's intent to close. During the same home visit, licensed practical nurse (LPN #4) confirmed to the patient the agency was closing and stated he should be receiving a letter in the mail from the agency regarding the closure. She further confirmed she had not notified Patient #1 about the agency closure prior to this date. LPN #4 stated she would contact the patient's physician regarding his mobility durable medical equipment (DME), but did not indicate she would notify his physician about the agency's plan to close and Patient #1 would be discharged from the agency. 5. The clinical record for Patient #5 was reviewed on 12/14/21. The plan of care for the certification period dated 9/1/21 to 10/30/21 revealed a start of care date of 9/12/19; diagnoses included pulmonary hypertension, COPD, cardiomegaly, occlusion and stenosis of carotid artery, hypokalemia, morbid obesity, and hyperlipidemia. Plan of care orders included SN visits once weekly for eight weeks and one visit PRN for illness, falls or medication changes and CNA visits twice weekly for once week, three times weekly for eight weeks, then once weekly for one week for assistance with personal care and ADLs. Physical therapy (PT) was added on 10/2/21 and the PT plan of care included orders for PT visits once weekly for one week then twice weekly for five weeks. Subsequent plan of care orders for the certification period dated 10/31/21 to 12/29/21 included SN visits once weekly for nine weeks and one visit PRN for illness, falls or medication changes and CNA visits twice weekly for once week, three times weekly for eight weeks, then once weekly for one week for assistance with personal care and ADLs. a) The agency failed to independently and autonomously initiate and implement appropriate discharge planning and maintain documentation of communication with patients and coordination with physicians to notify them a discharge for cause was being considered. Clinical review of Patient #5's record revealed Patient #5 required weekly SN assessment for safety and medication changes and assistance with showers three times weekly. Additionally, Patient #5 was taken to the emergency room (ER) on 11/29/21 due to having bloody stools and was diagnosed with COVID-19, discharged from the hospital to her home, and required to be isolated. The record revealed a communication note written by RN #2 stating Patient #5 reported her family was available to assist her with her showers while she isolated and her medication box still had two weeks worth of medication in it, so she would not need services from agency clinicians during her isolation period. Further review of Patient #5's record failed to reveal any documentation of communication with the patient and documentation of coordination with Patient #5's physician to notify them a discharge for cause was being considered. 6. Similar findings of the agency failing to document communication with the patient and coordination with the physician to notify them a discharge for cause was being considered was also found for Patient #4. 7. During interviews on 12/13/21 at 2:12 p.m., on 12/14/21 at 2:18 p.m. and 3:08 p.m., on 12/15/21 at 9:15 a.m., and on 12/16/21 at 8:30 a.m., the administrator stated the agency would be notifying all patients of the agency's intent to close via a formal letter. A request was made during each interview for the formal discharge letter. However, no letter was provided to the surveyors for review by survey exit.

Provide contact info other services CFR(s): 484.50(d)(5)(iii) (iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to document communication among home health agency management, patients and caregivers, legal representatives and physicians responsible for the plan of care regarding contact agencies or providers who may be able to provide care in 4 of 5 current patient records reviewed (Patients #1, #2, #4 and #5). Findings include: AGENCY POLICY According to the policy, "Transfer of Care," reviewed 7/9/19 (in part): "A contingency plan will be followed in the event of dissolution of the Agency to assure continuity of consumer care, assure the notification of consumers of the agency's dissolution and documentation of the notification and compliance with State procedures. In the event of Permanent Closure or Voluntary Suspension a. Each consumer or consumer's parent, family, spouse, significant other or legal representative will be notified in writing of the Agency closure and transfer. b. Each consumer's attending physician or practitioner will be notified of Agency closure in writing no later than five (5) days before the date on which the consumer will be transferred or discharged. The Agency will deliver the required notices by hand or mailed at least eight working days before the date of discharge or transfer. c. An agency member will speak with each consumer by telephone or in person to insure the consumer's knowledge of the transfer at least five (5) days before the date of transfer or discharge." 1. During an interview on 12/13/21 at 1:43 p.m. registered nurse clinical manager (RN #2) stated she wasn't sure if the state agency knew of the agency's intent to close. She stated she believed the current patients should receive a 30 day discharge notice with additional agencies to switch to, but was unsure if that notice had been drafted and distributed by the administrator yet. During an interview on 12/13/21 at 2:12 p.m., the administrator stated it didn't look like the agency could continue operating and he had directed the agency to stop accepting new patients two weeks ago. He stated the agency was trying to transition the patients and hired a consultant to help "navigate" the agency through the process. The administrator further stated the agency had provided a closure notice to the Department with the intended closure date of 12/31/21. He stated some patients had been notified, but the agency was working to provide a written formal notice to all patients with information about other potential agencies. 2. Review of documentation provided to the State Agency (SA) on 12/13/21 revealed the agency submitted a letter of intent to cease agency operations and close the agency effective 12/31/21. 3. The clinical record for Patient #2 was reviewed on 12/14/21. The plan of care for the certification period dated 9/10/21 to 11/8/21 revealed a start of care date of 1/13/21; diagnoses included heredity spastic paraplegia, chronic obstructive pulmonary disease (COPD), gastrointestinal hemorrhage, malignant neoplasm of bladder, and stage II pressure ulcers of bilateral buttock. plan of care orders included skilled nurse (SN) visits once weekly for eight weeks and two visits as needed (PRN) for acute issues or catheter problems and to change catheter every two weeks and certified nurse aide (CNA) visit once weekly for one week then three times weekly for eight weeks for assistance with personal care and activities of daily living (ADLs). An updated plan of care dated 10/13/21 following a hospitalization for the certification period dated 9/10/21 to 11/8/21 included orders for SN visits once weekly for four weeks and two visits PRN for acute issues or catheter problems and to change catheter every two weeks and CNA visits twice weekly for one week, three times weekly for three weeks, then once weekly for one week for assistance with personal care and ADLs. Subsequent plan of care orders for the certification period dated 11/9/21 to 1/7/22 included SN visits once weekly for nine weeks and two visits PRN for acute issues or catheter problems and to change catheter every two weeks and CNA visits twice weekly for one week the three times weekly for eight weeks for assistance with personal care and ADLs. a) The agency failed to independently and autonomously initiate and implement appropriate discharge planning and maintain documentation of communication with patients and coordination with physicians and other agencies to ensure continuity of care. Clinical review of Patient #2's record revealed Patient #2 required catheter changes every two weeks due to his diagnosis of malignant neoplasm of bladder, total assistance with all personal care tasks, and total assistance with transfers using a mechanical lift, which required the use of two people to ensure the patient's safety. Further review of Patient #2's record failed to reveal any documentation of communication with the patient and documentation of coordination with Patient #2's physician and other agencies to ensure continuity of care when the agency ceased operations. During a home visit on 12/15/21 beginning at 8:00 a.m., Patient #2 stated he was made aware of the agency's closure by his physician. He stated his physician was notified last week and he would be seeing his physician tomorrow to discuss alternative care. He stated he had not received written notification from the agency about his need to transfer agencies nor had he been provided information about alternative care. During the same interview, RN #3 stated she would return to see the patient next week and complete his official discharge from the agency once another agency agreed to provide him services. 4. The clinical record for Patient #1 was reviewed on 12/14/2021. The plan of care for the certification period dated 12/2/21 to 1/30/22 revealed a start of care date of 11/4/15; diagnoses included diabetes, hypertension, and schizophrenia. Plan of care orders included SN visits once weekly for eight weeks to perform a complete physical assessment with emphasis on diabetes and medication management. SN tasks also included the prefilling of insulin syringes and pillbox, per the medication profile. a) The agency failed to independently and autonomously initiate and implement appropriate discharge planning and maintain documentation of communication with patients and coordination with physicians and other agencies to ensure continuity of care. Clinical review of Patient #1's record revealed Patient #1 required weekly medication management. Specifically, Patient #1 required SN services to pre-fill syringes with insulin and pre-fill his medication box as Patient #1 lacked the cognitive ability due to his mental illness to do so safely and independently. Further review of Patient #1's record failed to reveal any documentation of communication with the patient and documentation of coordination with Patient #1's physician and other agencies to ensure continuity of care when the agency ceased operations. During a home visit on 12/14/21 beginning at 11:00 a.m., Patient #1 was asked by the State Agency (SA) surveyors if he was aware the agency was closing. Patient #1 stated he had not been notified, either verbally or in writing, of the agency's intent to close or that he would need to find alternative care. During the same home visit, licensed practical nurse (LPN #4) stated she would contact the patient's physician regarding his mobility durable medical equipment (DME), but did not indicate she would notify his physician about the agency's plan to close provide coordination with the physician to find alternative care for Patient #1 when the agency ceased operations. 5. The clinical record for Patient #5 was reviewed on 12/14/21. The plan of care for the certification period dated 9/1/21 to 10/30/21 revealed a start of care date of 9/12/19; diagnoses included pulmonary hypertension, COPD, cardiomegaly, occlusion and stenosis of carotid artery, hypokalemia, morbid obesity, and hyperlipidemia. Plan of care orders included SN visits once weekly for eight weeks and one visit PRN for illness, falls or medication changes and CNA visits twice weekly for once week, three times weekly for eight weeks, then once weekly for one week for assistance with personal care and ADLs. Physical therapy (PT) was added on 10/2/21 and the PT plan of care included orders for PT visits once weekly for one week then twice weekly for five weeks. Subsequent plan of care orders for the certification period dated 10/31/21 to 12/29/21 included SN visits once weekly for nine weeks and one visit PRN for illness, falls or medication changes and CNA visits twice weekly for once week, three times weekly for eight weeks, then once weekly for one week for assistance with personal care and ADLs. a) The agency failed to independently and autonomously initiate and implement appropriate discharge planning and maintain documentation of communication with patients and coordination with physicians and other agencies to ensure continuity of care. Clinical review of Patient #5's record revealed Patient #5 required weekly SN assessment for safety and medication changes and assistance with showers three times weekly. Additionally, Patient #5 was taken to the emergency room (ER) on 11/29/21 due to having bloody stools and was diagnosed with COVID-19, discharged from the hospital to return home, and required to be isolated. The record revealed a communication note written by RN #2 stating Patient #5 reported her family was available to assist her with her showers while she isolated and her medication box still had two weeks worth of medication in it, so she would not need services from agency clinicians during her isolation period. Further review of Patient #5's record failed to reveal any documentation of communication with the patient and documentation of coordination with Patient #5's physician and other agencies to ensure continuity of care when the agency ceased operations. 6. Similar findings of clinical records failing to document communication with the patient and coordination with the physician and other agencies to ensure continuity of care when the agency ceased operations was found for Patient #4. 7. During interviews on 12/13/21 at 2:12 p.m., on 12/14/21 at 2:18 p.m. and 3:08 p.m., on 12/15/21 at 9:15 a.m., and on 12/16/21 at 8:30 a.m., the administrator stated the agency would be notifying all patients of the agency's intent to close and provide additional agencies contact information via a formal letter. A request was made during each interview for the formal discharge letter. However, no letter was provided to the surveyors for review by survey exit.

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to develop and implement an effective discharge planning process and assist patients and their caregivers in selecting a new care provider by using and sharing data that includes, but is not limited to data on quality and resource use measures affecting 41 current agency patients. Findings include: AGENCY POLICY According to the policy, "Agency Organizational Guidelines," reviewed 7/9/19 (in part): "Dissolution of Agency In the event of dissolution of the Agency, we will assure continuity of consumer care by adhering to consumer transfer or discharge notifications as follows: Except in an emergency, the Agency will notify the consumer of the consumer's parent, family, spouse, significant other or legal representative and the consumer's attending physician (if applicable) seven (7) days before the consumer will be transferred or discharged. 1. The consumer will be notified of the Agency's dissolution. 2. The notification will be documented. 3. Agency closure will comply with Colorado Agency Closure Procedures." According to the policy, "Transfer of Care," reviewed 7/9/19 (in part): "A contingency plan will be followed in the event of dissolution of the Agency to assure continuity of consumer care, assure the notification or consumers of the agency's dissolution and documentation of the notification and compliance with State procedures." 1. During an interview on 12/13/21 at 1:43 p.m. registered nurse clinical manager (RN #2) stated she wasn't sure if the state agency knew of the agency's intent to close. She stated she believed the current patients should receive a 30 day discharge notice with additional agencies to switch to but was unsure if that notice had been drafted and distributed by the administrator yet. During an additional interview at 2:12 p.m., the administrator stated it didn't look like the agency could continue operating and he had directed the agency to stop accepting new patients two weeks ago. He stated the agency had hired a consultant to help "navigate" the agency through the process. The administrator further stated the agency had provided a closure notice to the Department with the intended closure date of 12/31/21. He stated the agency was in the middle of providing notices to all patients. He stated some patients had been notified, but the agency was working to provide a written formal notice to all patients regarding the agency's intent to close. 2. Review of documentation provided to the State Agency (SA) on 12/13/21 revealed the agency submitted a letter of intent to cease agency operations and close the agency effective 12/31/21. 3. On 12/14/21 at 2:18 p.m., the administrator was requested to provide a detailed discharge plan detailing the names of all current patients, the services they received, any documentation of coordination with patients, families, physicians, case managers and other agencies, and current discharge plans. On 12/15/21 at approximately 9:15 a.m., the administrator provided a document titled, "Detailed Discharge Plan - 12/1/2021," which consisted of a list of steps to take leading to closure of the agency. The plan failed to show any way to effectively track each patient's progress toward a safe and appropriate discharge. The administrator was unable to provide any information regarding the patients, their services, the priority of their needs, and the status of their transition to alternative services. Additionally, the administrator was unable to confirm if all patients had been notified, at least verbally, of the agency's intent to cease operations and the need of the patient to find alternative care. On 12/15/21 at 4:17 p.m., the administrator was provided with a blank spreadsheet which included all necessary information of the agency patients, their locations and payer sources, the level of care each patient required, the services being provided to each patient including frequency, contact information for families, physicians, case managers and other agencies in the area, and the specific discharge plan and disposition for each patient. Further, during interviews on 12/13/21 at 2:12 p.m., on 12/14/21 at 2:18 p.m. and 3:08 p.m., on 12/15/21 at 9:15 a.m., and on 12/16/21 at 8:30 a.m., the administrator stated the agency would be notifying all patients of the agency's intent to close and provide alternate agency contact information via a formal letter. A request was made during each interview for the formal discharge letter. However, no letter was provided to the surveyors for review by survey exit. 4. Clinical record review of four current patients (Patients #1, #2, #4 and #5) failed to reveal any documentation of communication, verbal or written, from the agency to the patient, their family/representative, their physicians, their case managers (if applicable), and other home health agencies regarding the agency's intent to cease operations and the agency's attempt to secure continued skilled care on the patients' behalf. 5. During a home visit on 12/14/21 beginning at 11:00 a.m., Patient #1 was informed of the agency's intent to close by the state agency (SA) surveyor. Patient #1 stated he had not been notified, either verbally or in writing, of the agency's intent to close. During the same home visit, licensed practical nurse (LPN #4) confirmed to the patient the agency was closing and stated he should be receiving a letter in the mail from the agency regarding the closure. She further confirmed she had not notified Patient #1 about the agency closure prior to this date. LPN #4 stated she would contact the patient's physician regarding his mobility durable medical equipment (DME), but did not indicate she would notify his physician about the agency's plan to close and Patient #1 would be discharged from the agency and would need information about alternative care. 6. During a home visit on 12/15/21 beginning at 8:00 a.m., Patient #2 stated he had been made aware of the agency's intent to close by his physician, and not by agency staff. During a home visit on 12/15/21 beginning at 8:00 a.m., Patient #2 stated he was made aware of the agency's closure by his physician. He stated his physician was notified last week and he would be seeing his physician tomorrow to discuss alternative care. He stated he had not received written notification from the agency about his need to transfer agencies nor had he been provided information about alternative care. During the same interview, RN #3 stated she would return to see the patient next week and complete his official discharge from the agency once another agency agreed to provide him services. 7. During an interview on 12/16/21 at 10:12 a.m., RN #2 was provided with the appropriate contact electronic mail (email) addresses for appropriate SA personnel to provide updated discharge spreadsheets daily to ensure the safe and appropriate discharge of all 41 patients currently being served by the agency that would meet state and federal regulatory standards.

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 nature 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 systemic process failures that had the potential to affect all patients cared for by the agency. A total of seven clinical records were reviewed for compliance with the Condition and Standards for Care Planning, Coordination and Quality of Care. Record review revealed a pattern of failures in regard to the establishment and implementation of patients' plans of care. Specifically, the agency failed to ensure each patient received home health services in accordance with a written plan of care established, reviewed and authorized by a physician prior to rendering services; to ensure services and treatments were provided in conformance with physician's orders; and to ensure services and treatments were provided only as ordered by the physician. The following standard level deficiencies were also cited: G574 - Standard: The Plan of Care must include- The agency failed to ensure each patient's plan of care included all types of services and treatments, supplies, equipment and nutritional requirements. G578 - Standard: Conformance with Physician Orders- The agency failed to ensure services and treatments were provided in conformance with physician's orders. G580 - Standard - Only as ordered by the Physician - The agency failed to provide services and treatments only as ordered by the physician. During an interview on 12/13/21 at 2:38 p.m., the registered nurse clinical manager (RN #2) stated patient plans of care were generated directly from the Outcome and Assessment Information Set (OASIS) comprehensive assessment. Once generated, the plan of care order was created in the Electronic Medical Record (EMR) system and sent to the physician by facsimile (fax). She stated the physician would then review and sign the plan of care and return it to the agency via fax usually within 30 days. RN #2 further stated agency clinicians did not receive verbal orders for the plan of care and rendered treatment and services to patients while the agency awaited return receipt of the physician authorized plan of care.

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 ensure each patient's plan of care included measurable outcomes and goals identified by the home health agency (HHA) and the patient and additional items the HHA chose to include, specifically the homebound narrative and medical necessity for home health services for 5 of 5 current patients reviewed, who received skilled nursing services (Patients #1, #2, #3, #4 and #5). Findings include: AGENCY POLICY According to the policy, "Care Plan," reviewed 7/9/19 (in part): "Steps to be taken in developing the care plan included: 2. Identification of the consumer's continuing need for home care and meet the consumer's medical, nursing, rehabilitative, social and discharge planning needs including health needs/problems with which a consumer/family needs assistance. 6. Determination of the goals to be achieved; both short and long term goal." 1. The clinical record for Patient #5 was reviewed on 12/14/21. The plan of care for the certification period dated 9/1/21 to 10/30/21 revealed a start of care date of 9/12/19; diagnoses included pulmonary hypertension, chronic obstructive pulmonary disease (COPD), cardiomegaly, occlusion and stenosis of carotid artery, hypokalemia, morbid obesity, and hyperlipidemia. Plan of care orders included skilled nurse (SN) visits once weekly for eight weeks and one visit as needed (PRN) for illness, falls or medication changes and certified nurse aide (CNA) visits twice weekly for once week, three times weekly for eight weeks, then once weekly for one week for assistance with personal care and activities of daily living (ADLs). Physical therapy (PT) was added on 10/2/21 and the PT plan of care included orders for PT visits once weekly for one week then twice weekly for five weeks. Subsequent plan of care orders for the certification period dated 10/31/21 to 12/29/21 included SN visits once weekly for nine weeks and one visit PRN for illness, falls or medication changes and CNA visits twice weekly for once week, three times weekly for eight weeks, then once weekly for one week for assistance with personal care and ADLs. a) Record review revealed the agency failed to ensure Patient #5's plan of care included specific goals, a description of the medical necessity allowing the patient to receive skilled services and a narrative indicating why the patient was homebound and should receive home health services. Review of the plans of care for the certification periods dated 9/1/21 to 10/30/21 and 10/31/21 to 12/29/21 showed under the orders for discipline and treatment section, the SN was to notify the physician immediately of any potential problems that impeded the patient's recovery and desired goals. However, the plans of care failed to show any information in the goals section of the plan of care. Rather, the section included the statement "there is no data for this section." Continued review of the plans of care showed that in the physician or allowed practitioner statement, the physician stated they certified/recertified the patient was confined to their home and needed intermittent skilled nursing care and physical therapy. However, the plans of care failed to show any information in the homebound narrative and the section to document medical necessity. Rather, the sections included the statement "there is no data for this section." 2. The clinical record for Patient #2 was reviewed on 12/14/21. The plan of care for the certification period dated 9/10/21 to 11/8/21 revealed a start of care date of 1/13/21; diagnoses included heredity spastic paraplegia, COPD, gastrointestinal hemorrhage, malignant neoplasm of bladder, and stage II pressure ulcers of bilateral buttock. Plan of care orders included SN visits once weekly for eight weeks and two visits as needed (PRN) for acute issues or catheter problems and to change catheter every two weeks and CNA visit once weekly for one week then three times weekly for eight weeks for assistance with personal care and ADLs. An updated plan of care dated 10/13/21 following a hospitalization for the certification period dated 9/10/21 to 11/8/21 included orders for SN visits once weekly for four weeks and two visits PRN for acute issues or catheter problems and to change catheter every two weeks and CNA visits twice weekly for one week, three times weekly for three weeks, then once weekly for one week for assistance with personal care and ADLs. Subsequent plan of care orders for the certification period dated 11/9/21 to 1/7/22 included SN visits once weekly for nine weeks and two visits PRN for acute issues or catheter problems and to change catheter every two weeks and CNA visits twice weekly for one week the three times weekly for eight weeks for assistance with personal care and ADLs. a) Record review revealed the agency failed to ensure Patient #2's plan of care included a narrative indicating why the patient was homebound and should receive home health services. Review of the plans of care for the certifications periods dated 9/10/21 to 11/8/21 and 11/9/21 to 1/7/22 showed in the physician or allowed practitioner statement, the physician stated they certified/recertified the patient was confined to their home and needed intermittent skilled nursing care. However, the plans of care failed to show any information in the homebound narrative. Rather, the section included the statement "there is no data for this section." 3. The clinical record for Patient #4 was reviewed on 12/15/21. The plan of care for the certification period dated 8/12/21 to 10/10/21 revealed a start of care date of 9/2/17; diagnoses included malignant neoplasm of colon and abnormal weight loss. Plan of care orders included SN visits once every 60 days and CNA visits once weekly for one week then three times weekly for eight weeks for assistance with personal care and ADLs. Subsequent plan of care orders for the certification period dated 10/11/21 to 12/9/21 included SN visits once every 60 days and CNA visits three times weekly for nine weeks and the orders for the certification period 12/10/21 to 2/7/22 included SN visits once every 60 days and CNA visits once weekly for one week then three times weekly for eight weeks for assistance with personal care and ADLs. a) Record review revealed the agency failed to ensure Patient #4's plan of care included a narrative indicating why the patient was homebound and should receive home health services. Review of the plans of care for the certification periods dated 8/12/21 to 10/10/21, 10/11/21 to 12/9/21 and 12/10/21 to 2/7/22 showed in the physician or allowed practitioner statement, the physician stated they certified/recertified the patient was confined to their home and needed intermittent skilled nursing care. However, the plans of care failed to show any information in the homebound narrative. Rather, the section included the statement "there is no data for this section." 4. Similar findings of the plans of care failing to include all necessary information was found with Patients #1 and #3. 5. During an interview on 12/15/21 at 11:54 a.m., the registered nurse clinical manager (RN #2) stated she told the nurses to specifically indicate in the homebound narrative if a patient was homebound or not. Additionally, she stated information on the plan of care was automatically generated from the completed Outcome and Assessment Information Set (OASIS) comprehensive assessments. She acknowledged missing information on the plans of care should have been caught during a review, however, she stated she reviewed the comprehensive assessments for completeness and accuracy but did not review the individual plans of care because she believed all the necessary information would have carried over from the OASIS comprehensive assessments.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure services and treatments were provided in accordance with physician's orders for 1 of 1 patient records reviewed who received skilled nursing (SN) for diabetes medication management (Patient #1). Findings include: 1. The clinical record for Patient #1 was reviewed on 12/14/2021. The Plan of Care (POC) for the certification period dated 12/2/21 to 1/30/22 revealed a start of care date of 11/4/15; diagnoses included diabetes, hypertension and schizophrenia. POC orders included skilled nurse (SN) visits once weekly for eight weeks to perform a complete physical assessment with emphasis on diabetes and medication management. SN tasks also included the prefill of insulin syringes and pillbox, per the medication profile. a) The agency failed to ensure the SN pre-filled syringes with insulin Levemir in accordance with physician orders per the POC. A review of the POC for the certification period dated 12/2/21 to 1/30/22 showed the SN was ordered to pre-fill syringes with Levemir and Novalog insulins every week. Further review of the patient's medication profile for the same certification period date, 12/2/21 to 1/30/22 showed Levemir 70 units (100units/milliliter) subcutaneous every morning and evening was stopped on 7/8/2021 and Tresiba 70 units (100units/milliliter) subcutaneous every morning and evening was started on 7/15/21. A home visit was conducted at the patient's home on 12/14/21 at 11:00 a.m. During the home visit, Patient #1 stated the agency nurses would fill his insulin syringes with the Tresiba and Novalog medications because he wouldn’t always remember to do it himself. Observation during the home visit showed the Licensed Practical Nurse (LPN #4) pre-filled the syringes with the Tresiba and Novalog medications while utilizing the medication profile contained in a folder in the patient's home. When asked why the LPN was not prefilling syringes with the Levemir medication according to the POC orders, LPN #4 stated the Levemir medication had been discontinued several months ago. During an interview on 12/16/21 at 12:30 p.m., the registered nurse clinical manager (RN #2) was asked to clarify the order for the SN to prefill syringes with the Levemir medication. RN #2 stated Levemir had been discontinued when the Tresiba medication was added and she must have forgotten to remove the sentence on the POC that directed the SN to prefill the patient's insulin syringes with the Levemir medication. RN #2 acknowledged the discrepancy and stated it would be corrected as soon as possible.

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 drugs, services and treatments were administered as ordered by a physician for seven of seven patient records reviewed (Patients #1, #2, #3, #4, #5, #6 and #7). Findings include: AGENCY POLICY According to agency policy titled, “Verbal/Telephone Orders”, reviewed 7/9/19 (in pertinent parts): The purpose was to provide review, approval and signature of physician orders in compliance with applicable law and regulation. To provide an accurate plan of care/treatment as well as updates as needed, and, to provide liability coverage to all licensed personnel. 1. The clinical record for Patient #5 was reviewed on 12/14/21. The Plan of Care (POC) for the certification period dated 9/1/21 to 10/30/21 revealed a start of care date of 9/12/19; diagnoses included pulmonary hypertension, chronic obstructive pulmonary disease (COPD), cardiomegaly, occlusion and stenosis of the carotid artery, hypokalemia, morbid obesity, and hyperlipidemia. POC orders included skilled nurse (SN) visits once weekly for eight weeks and one visit as needed (PRN) for illness, falls or medication changes and certified nurse aide (CNA) visits twice weekly for once week, three times weekly for eight weeks, then once weekly for one week for assistance with personal care and activities of daily living (ADLs). Subsequent POC orders for the certification period dated 10/31/21 to 12/29/21 included SN visits once weekly for nine weeks and one visit PRN for illness, falls or medication changes and CNA visits twice weekly for once week, three times weekly for eight weeks, then once weekly for one week for assistance with personal care and ADLs. a) The agency failed to ensure care and services were provided only as ordered by the physician. Review of the POC for the recertification period dated 10/31/2021 to 12/29/2021 showed the POC was developed by the clinical manager (RN #2) on 10/28/2021. Further review revealed the physician of record did not sign the Plan of Care, including the orders for disciplines and treatment, to include SN and CNA services, until 12/3/2021, 34 days after the new certification period had begun. Further record review showed the CNA provided 13 visits without physician’s orders, between 10/31/21 and 12/3/2 before the physician had countersigned the POC, with tasks that included assistance with activities of daily living, personal hygiene, nutrition and elimination. Additional document review showed the SN provided two visits between the same time period of 10/31/21 and 12/3/21, and had assessed the patient's COPD disease status and medication management along with a complete physical assessment without physician orders. Record review revealed no evidence an agency registered nurse (RN) had contacted the physician to discuss the POC or obtain verbal orders prior to the continuation of SN or CNA services when the new certification period had begun. 2. The clinical record for Patient #3 was reviewed on 12/14/2021. The POC for the certification period dated 11/8/21 to 1/6/22 revealed a start of care date of 9/14/20; diagnoses included amputation stump infection and hypertension. POC orders included SN visits three times per week for eight weeks to perform patient assessment, education, and instruction, with emphasis on the left above-knee amputation (AKA) wound. The SN was also ordered to perform wound care by cleansing the wound with wound wash, apply wound packing, cover and, secure with a wound dressing using aseptic technique. a) The agency failed to ensure care and services were provided only as ordered by the physician. Review of the Plan of Care for the recertification period dated 11/8/21 to 1/6/22 showed the POC was developed by RN #3 on 11/5/2021. Further review revealed the physician of record did not sign the POC, including the orders for disciplines and treatment of SN services, until 12/3/2021, 26 days after the new certification period had begun. Further record review showed the SN provided 10 visits without physician’s orders, 11/8/21 and 12/3/21 before the physician had countersigned the POC, with tasks that included wound care with dressing changes, pain management and the assessment of the patient's hypertension status. Record review revealed no evidence an agency RN had contacted the physician to discuss the POC or obtain verbal orders prior to the continuation of SN services when the new certification period had begun. 3. The clinical record for Patient #4 was reviewed on 12/15/21. The POC for the certification period dated 8/12/21 to 10/10/21 revealed a start of care date of 9/2/17; diagnoses included malignant neoplasm of colon and abnormal weight loss. POC orders included SN visits once every 60 days and CNA visits once weekly for one week then three times weekly for eight weeks for assistance with personal care and ADLs. Subsequent POC orders for the certification period dated 10/11/21 to 12/9/21 included SN visits once every 60 days and CNA visits three times weekly for nine weeks and the orders for the certification period 12/10/21 to 2/7/22 included SN visits once every 60 days and CNA visits once weekly for one week then three times weekly for eight weeks for assistance with personal care and ADLs. a) The agency failed to ensure care and services were provided only as ordered by the physician. Review of the POC for the recertification period dated 10/11/21 through 12/9/21 showed the POC was developed by RN #7 on 10/8/2021. Further review revealed the physician of record did not sign the Plan of Care, including the orders for disciplines and treatment, to include SN and CNA services, until 11/1/2021, 22 days after the new certification period had begun. Additional review showed a physician order dated 10/8/21, RN #7 requested the continuation of home health services and a SN once every 60 days to assess body systems, instruct on disease processes and assess medications, along with CNA visits three times per week to assist with personal care, showers and transfers. Further review showed the physician had signed the order on 10/22/21,15 days after the new certification period had begun. Further record review showed the CNA provided 6 visits without physician’s orders, from 10/11/21 to 10/22/21, before the physician had countersigned the recertification physician's order. Neither the physician-driven POC nor physician order documents contained any evidence to show the physician had been contacted to obtain verbal orders prior to the continuation of SN or CNA services when the new certification period had begun. 4. Similar findings of agency clinicians providing care only as ordered by a physician were found for patients #1, #2, #6 and #7. 5. During an interview on 12/13/2021 at 2:30 p.m., RN #2 stated the recertification POC was developed upon completion and documentation of the comprehensive recertification assessment. She stated the POC was then forwarded to the physician for review and signature with the expectation it would be signed and returned to the agency within 30 days. RN #2 also stated the office manager (Employee #8) would track to ensure the POC was signed and returned. RN #2 went on to state it was not part of standard clinical processes to contact the patient's physician to discuss comprehensive assessment findings or obtain verbal orders to continue skilled nursing services until the signed POC is returned. During an interview on 12/15/21 at approximately 10:00 a.m., RN #5 stated she would not routinely contact a physician to discuss the recertification POC or obtain verbal orders to continue skilled nursing services until the POC could be reviewed and countersigned by the physician. RN #5 stated it was agency procedure that the RN would develop the POC and it was then forwarded to Employee #8 to fax and track the return of the signed POC. RN #5 stated she was unaware she needed to obtain verbal orders to provide continued services until the POC was signed.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to implement a quality assessment and performance improvement (QAPI) program which evaluated all agency services and complied with the requirements and standards set forth in CFR 484.65. The failure created the potential for the agency to overlook trends which affected the quality of services and care provided to its patients and put patients' safety at risk. Findings include: AGENCY POLICY According to agency policy titled, “8.1 Scope of Services”, reviewed 7/9/19, (in pertinent parts): "It is the policy of this Agency to implement and maintain a Quality Assessment and Performance Improvement (QAPI) Program designed to have a method to monitor and evaluate the quality and appropriateness of consumer [patient] care. It also demonstrates the Agency’s commitment to continually provide quality health care. QAPI committee members will consist of the agency administrator, director of nursing, a community registered nurse, and a member from each service discipline the agency offers. It would be the responsibility of the QAPI committee to assist in carrying out the monitored and evaluated objectives and activities that were identified in the developed QAPI plan." According to agency policy titled, “8.4 Responsibility”, reviewed 7/9/19, (in pertinent parts): "The Governing Body [GB] assumes overall responsibility and oversight of the QAPI program. The Professional Advisory Committee (PAC) assumes responsibility for the creation and support of the QAPI program. The agency administrator was responsible for assuring QAPI implementation and maintenance, accomplished in cooperation with the managerial staff and the QAPI committee." During an interview on 12/14/2021 at 2:00 p.m., the registered nurse clinical manager (RN #2) stated she believed she was the one in charge of QAPI activities after the alternate administrator (Employee #7) had suddenly become ill in September 2021. RN #2 stated the agency did have a QAPI committee assembled but QA (quality assurance) meetings had fallen "by the wayside” following the sudden death of the agency chief operating officer (CEO) and the resignation of the former administrator. RN #2 stated complications related to the COVID pandemic and staff shortages also contributed to the agency's inability to hold regular QAPI meetings. She went on to state she did not believe the agency had an active QAPI program for at least a couple of years. RN #2 stated she would have QA discussions in passing with agency staff, but nothing was formally documented. The clinical manager (RN #2) also stated the agency had an active governing board (GB) and that board members would meet monthly to discuss agency agenda items, however, QAPI activities had not been part of the routine agenda. RN #2 provided a binder for review and stated this was the only documentation available that outlined any QAPI activities. A review of the binder documentation showed several tabs labeled to contain different logs that included a lab results log, emergency room (ER) log, infection control, hospitalizations, and adverse events. The logged documentation in the binder revealed the last time an entry was made was in 2017. During an interview on 12/14/21 at 2:14 p.m., Administrator #1 stated he was unaware of a current QAPI program or any QAPI activities but he would ask the alternate administrator (RN #7) if she had any knowledge or documentation of past QAPI details. On 12/16/2021 at approximately 3:00 p.m., the agency office manager (Employee #8) provided GB minutes for 2017, 2018, and 2019. The administrator stated any discussion of the QAPI program should be contained within the minutes, however, review of the minutes revealed the last time any QAPI activities had been discussed was in August 2019, over two years ago. No additional information for 2020 and 2021 was provided. In summary, the agency failed to ensure they had implemented and maintained a quality assessment and performance improvement (QAPI) program which evaluated all agency services and complied with the requirements and standards set forth in CFR 484.65.

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 nature 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 deficient practice illustrated systemic process failures that had the potential to affect all patients cared for by the agency. Interview and record review revealed the Administrator of the agency failed to organize, manage, and administer the agency's day to day operations in order to maintain the highest practicable functional capacity of the agency, 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 administrator failed to provide basic functional oversight of the operations of the agency. Patient health and safety were put at risk due to a lack of administrative oversight directing the agency's on-going functions on a day-to-day basis and a lack of clinical oversight in directing the delivery of patient care and services. The following standard level deficiencies were also cited: G948 - Standard: The Administrator failed to organize and direct the agency's day to day operations. Specifically, the agency was cited with failure to ensure the implementation of each patient's individualized and accurate plan of care, ensure care and treatment, including wound care, was provided only as ordered by a physician, ensure care and treatment was provided in accordance with physician orders, ensure the agency had a comprehensive and complete Quality Assurance Performance Improvement (QAPI) program to consistently address agency operations, needs for improvement and goals, ensure the individual patient rights regarding discharge were upheld for all patients, and ensure the agency employed qualified personnel for the administrator and alternate administrator positions. G952 - Standard: The administrator failed to ensure the agency employed qualified personnel. Specifically, the administrator failed to produce his own personnel record for review to confirm he was qualified to perform the duties of an administrator. G956 - Standard: The administrator failed to ensure he or his qualified alternate administrator were available during all operating hours. Specifically, the administrator was difficult to reach by agency personnel and did not arrive at the agency until approximately two hours after the initiation of the survey. Additionally, when the surveyors would request to speak with the administrator, agency staff would attempt to make contact with him, but were not able to reach him, for up to 3 hours at times. Contact information, specifically the administrators electronic mail (email) address was provided to the surveyors directly from the administrators two days after the initiation of the survey. Further, the administrator deferred all clinical and most administrative questions to agency registered nurses (RNs), spent a collective five hours and seven minutes readily available to the surveyors during the time of the inspection, and was not present during exit conference despite having adequate notice as to the time of the exit.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the administrator failed to organize and direct the agency's day to day operations. Specifically, the agency was cited with failure to ensure the implementation of each patient's individualized and accurate plan of care, ensure care and treatment, including wound care, was provided only as ordered by a physician, ensure care and treatment was provided in accordance with physician orders, ensure the agency had a comprehensive and complete Quality Assurance Performance Improvement (QAPI) program to consistently address agency operations, needs for improvement and goals, ensure the individual patient rights regarding discharge were upheld for all patients, and ensure the agency employed qualified personnel for the administrator position. Findings include: AGENCY POLICY According to the policy, "1.1 Introduction," reviewed on 7/9/19 (in part): "All services are provided under the direction of the Administrator and the Director of Nursing. Colorado Plains Home Health, LLC adheres to standards set forth by Federal, State, Local and Accrediting Bodies." According to the policy, "1.9 Agency Organizational Guidelines," reviewed on 7/9/19 (in part): "The Agency shall at all times comply with all applicable regulations of the United States Department of Health and Human Services, and all rules, regulations and guidelines set forth by the state and local governments." According to the policy, "1.18 State Regulatory Requirements," reviewed 7/9/19 (in part): "The Agency Administrator is responsible for identifying exceptional regulatory requirements that are state specific and affect the application of administrative policy and procedure." According to the policy, "1.20 Agency Supervision," reviewed 7/9/19 (in part): "2. Administrator's Duties: the Administrator is authorized to organize and direct the Agency's on-going functions. The Administrator's duties shall be to: a. Organize and direct the Agency's on-going operations to assure the availability and provision of care and services. c. Comply with applicable laws and regulations. e. Recruit, employ and retain qualified personnel to maintain appropriate staffing levels. g. Direct and monitor organizational performance improvement activities. 3. The Administrator will appoint a qualified alternate to assume his/her duties in his/her absence." 1. The administrator failed to ensure agency clinicians provided care only as ordered by the physician. This failure created the potential for harm to the safety and welfare of the patients who received nursing services. Further, this resulted in patients receiving treatments and/or medications without the physician's knowledge of the specific care and services being provided to patients from anywhere between two to and five weeks. Review of the clinical records for Patient's #1, #2, #3, #4, #5, #6 and #7 revealed agency clinicians, including the registered nurse (RN), physical therapist (PT) and certified nurse aide (CNA) provided care and services to patients prior to the authorization of those services by the physicians. During an interview on 12/13/21 at 2:38 p.m., the registered nurse clinical manager (RN #2) stated patient plans of care were generated directly from the Outcome and Assessment Information Set (OASIS) comprehensive assessment. Once generated, the plan of care order was created in the Electronic Medical Record (EMR) system and sent to the physician by facsimile (fax). She stated the physician would then review and sign the plan of care and return it to the agency via fax "usually" within 30 days. RN #2 further stated agency clinicians did not receive verbal orders for the plan of care and rendered treatment and services to patients while the agency awaited return receipt of the physician authorized plan of care. Cross reference G580 2. The administrator failed to ensure clinical documentation was complete and accurate. Specifically, the administrator failed to ensure the plans of care had accurate information regarding medication orders, thus ensuring patients received accurate medications, and plans of care included all necessary information to meet regulatory standards. Review of the clinical records for Patient's #1, #2, #3, #4 and #5 revealed plans of care for multiple certification periods failed to contain all information pertinent to the patient's receiving skilled home health services. Additional review of Patient #1's record revealed incorrect insulin information on the most recent plan of care, which put Patient #1 at risk for receiving the wrong or too much insulin during any SN visit. During an interview on 12/15/21 at 11:54 a.m., the RN #2 stated she told the nurses to specifically indicate in the homebound narrative if a patient was homebound or not. Additionally, she stated information on the plan of care was automatically generated from the completed OASIS comprehensive assessments. She acknowledged missing information on the plans of care should have been caught during a review, however, she stated she reviewed the comprehensive assessments for completeness and accuracy but did not review the individual plans of care because she believed all the necessary information would have carried over from the OASIS comprehensive assessments. Cross reference G574 and G578 3. The administrator failed to implement and maintain a QAPI program which evaluated all agency services and complied with the requirements and standards set forth in CFR 484.65. The failure created the potential for the agency to overlook trends which affected the quality of services and care provided to its patients and put patients' safety at risk. During interview on 12/14/2021 at approximately 2:00 p.m., RN #2 stated she believed she was the one in charge of QAPI activities after the alternate administrator on record (Employee #7) had suddenly become ill and resigned her position as the director of nursing (DON) in September 2021. She stated the agency did have a QAPI committee assembled but QA (quality assurance) meetings had fallen "by the wayside” recently and complications related to the COVID-19 pandemic and staff shortages also contributed to the inability of the agency to hold regular QAPI meetings. She went on to state she did not believe the agency had an active QAPI program for at least a couple of years. RN #2 stated she had QA discussions in passing with agency staff, but nothing was formally documented. During an interview on 12/14/21 at 2:14 p.m., the administrator stated he was unaware of a current QAPI program or any QAPI activities, but he would ask Employee #7 if she had any knowledge or documentation of past QAPI committee details. On 12/16/2021 at approximately 3:00 p.m., the agency receptionist (Employee #8) provided governing body minutes from 2017, 2018 and 2019 the administrator had given her to photo copy. The administrator stated discussion of the QAPI program should be contained within the minutes, however, review of the minutes revealed the last time any QAPI activities had been discussed was in August 2019, over two years ago. No additional information was provided for 2020 and 2021. Cross reference G640 4. The administrator failed to protect the rights of the patients serviced by the agency regarding discharge notification and failed to follow regulation for safe transition of care for 41 patients currently served by the agency. Specifically, the agency failed to independently and autonomously provide verbal notice to all current patients of the agency's intent to cease operations nor had the agency provided assistance to the current patients to make contact with and transfer to alternative care. Additionally, the agency had not provided patients with a formal written notice of discharge by the exit of the survey. This failure created the potential for 41 skilled patients to be without care for an unknown length of time. Review of the clinical records for Patient's #1, #2, #3, #4 and #5 failed to reveal documentation that patients, their physicians and/or their case managers had been notified by agency personnel of the agency's intent to close and the need to discharge their services. During an interview on 12/13/21 at 1:43 p.m., RN #2 stated she wasn't sure if the state agency knew of the agency's intent to close. She stated she believed the current patients should receive a 30 day discharge notice with additional agencies to switch to but was unsure if that notice had been drafted and distributed by the administrator yet. During an additional interview at 2:12 p.m., the administrator stated it didn't look like the agency could continue operating and he had directed the agency to stop accepting new patients two weeks ago. He stated the agency was trying to transition the patients and hired a consultant to help "navigate" the agency through the process. The administrator further stated the agency had provided a closure notice to the Department with the intended closure date of 12/31/21. He stated the agency was in the middle of providing notices to all patients. He stated some patients had been notified, but the agency was working to provide a written formal notice to all patients with information about other potential agencies. During a home visits on 12/15/21 beginning at 8:00 a.m., Patient #2 stated he was made aware of the agency's closure by his physician. He stated his physician was notified last week and he would be seeing his physician tomorrow to discuss alternative care. He stated he had not received written notification from the agency about his need to transfer agencies. During the same interview, RN #3 stated she would return to see the patient next week and complete his official discharge from the agency once another agency agreed to provide him services. A request was made for the formal written discharge letter from the agency following the interview with the administrator on 12/13/21 at 2:12 p.m., on 12/14/21 at 2:18 p.m. and 3:08 p.m., on 12/15/21 at 9:15 a.m., and on 12/16/21 at 8:30 a.m. However, no letter was provided to the surveyors for review. Cross reference G406, G464, G468 and G562 5. The administrator failed to ensure the agency employed qualified personnel. Specifically, the administrator was not found to be qualified to perform the duties of administrator in accordance with regulation. The administrator failed to produce his own personnel record for review to confirm he was qualified to perform the duties of an administrator either by previous education and experience to show his qualifications to be the agency administrator. During an interview on 12/16/21 at 9:03 a.m., the administrator stated he "doubted" he had a personnel record at the agency. He stated he was part of the Board of Directors as a "financial guy" and came over to the agency to help the alternate administrator. He stated the alternate administrator became ill and he had to take control of the agency immediately in September 2021. The administrator further stated he had previously been a chief executive officer for home care and felt that qualified him to be the administrator. He was unable to produce evidence of his previous experience to show his qualifications to be the agency administrator. Cross reference G952 6. The administrator failed to ensure he or his qualified alternate administrator were available during all operating hours. Specifically, the administrator was difficult to reach by agency personnel and did not arrive at the agency until approximately two hours after the initiation of the survey. When the surveyors would request to speak with the administrator, agency staff would attempt to make contact with him, but were not able to reach him, for up to 3 hours at times. Contact information, specifically the administrator's electronic mail (email) address was provided to the surveyors directly from the administrator two days after the initiation of the survey. Additionally, the alternate administrator was unable to be reached by surveyors despite requests to speak with her on 12/15/21 and 12/16/21. Further, the administrator deferred all clinical and most administrative questions to agency registered nurses (RNs), spent a collective five hours and seven minutes readily available to the surveyors during the time of the inspection (12/13/21 to 12/16/21), and was not present during the exit conference despite having adequate notice as to the time of the exit. During an interview on 12/13/21 at 2:12 p.m., the administrator stated his primary vocation was as the chief financial officer (CFO) for a nearby clinic. He further stated he was unable to stay at the agency and assist the surveyors and would need to work on having someone here the following day. The administrator was only available to the surveyors for a total of 18 minutes. On 12/14/21, the administrator was only available to the surveyors for a total of two hours and 12 minutes. On 12/15/21, the administrator was only available to the surveyors for a total of one hour and 52 minutes. The administrator provided his email address for contact. On 12/16/21, the administrator was only available to the surveyors for a total of 45 minutes and did not participate in the exit conference. Cross reference G956

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the administrator failed to ensure the home health agency employed qualified administrative staff. This failure was found for the agency administrator (Employee #1). Findings include: 1. On 12/15/21 at approximately 2:00 p.m., personnel records, including the record for the administrator were requested for review. The agency failed to maintain a personnel record for the administrator. The administrator was unable to confirm he was qualified to perform the duties of an administrator either by previous education and experience to show his qualifications to be the agency administrator. During an interview on 12/16/21 at 9:03 a.m., the administrator stated he "doubted" he had a personnel record at the agency. He stated he was part of the Board of Directors as a "financial guy" and came over to the agency to help the alternate administrator. He stated the alternate administrator became ill and he had to take control of the agency immediately in September 2021. The administrator further stated he had previously been a chief executive officer (CEO) for a home care company and felt that qualified him to be the administrator. He was unable to produce evidence of his previous employment or experience to show his qualifications to be the agency administrator.

Available during all operating hours CFR(s): 484.105(b)(3) The administrator or a pre-designated person is available during all operating hours. This ELEMENT is not met as evidenced by: Based on observation and interview, the administrator failed to ensure he or his qualified alternate administrator were available during all operating hours. Findings include: 1. On 12/13/21 at 12:10 p.m., the state agency (SA) surveyors arrived at the agency office. The door was locked, lights were turned off and there was no answer to knocks on the door. A phone call was placed to the agency at that time and a voicemail was left requesting a return call by 12:45 p.m. The outgoing voicemail provided a phone number for the "on call nurse" and a call was placed to that number. The call could not be connected and the message stated the recipient had a mailbox that had not yet been set up. The surveyor was unable to leave a voicemail. The agency office was observed to be locked and empty and another call was placed to the agency at 12:45 p.m., notifying the agency a deficiency would be cited for failure to be available for a survey. The surveyors then left the building to further research additional contact phone numbers for the agency and its personnel. At 1:10 p.m., the surveyors re-entered the building to inquire about the agency from an adjacent business when the agency office was observed to be open. At that time, the surveyors entered the agency to initiate the inspection. The only employee present was the office manager (Employee #8) who stated she had already spoken to the registered nurse clinical manager (RN #2), but had been unable to reach the administrator. 2. The administrator was difficult to reach by agency personnel and did not arrive at the agency until approximately two hours after the initiation of the survey. When the surveyors would request to speak with the administrator, agency staff would attempt to make contact with him, but were not able to reach him, for up to 3 hours at times. Contact information, specifically the administrator's electronic mail (email) address was provided to the surveyors directly from the administrator two days after the initiation of the survey. Additionally, the alternate administrator was unable to be reached by surveyors despite requests to speak with her on 12/15/21 and 12/16/21. Further, the administrator deferred all clinical and most administrative questions to agency registered nurses (RNs), spent a collective five hours and seven minutes readily available to the surveyors during the time of the inspection (12/13/21 to 12/16/21), and was not present during the exit conference despite having adequate notice as to the time of the exit. During an interview on 12/13/21 at 2:12 p.m., the administrator stated his primary vocation was as the chief financial officer (CFO) for a nearby clinic. He further stated he was unable to stay at the agency and assist the surveyors and would need to work on having someone here the following day. The administrator was available to the surveyors for a total of 18 minutes. On 12/14/21, the surveyors arrived at the agency at approximately 9:00 a.m. Only Employee #8 was available. During an interview on 12/14/21 at 10:30 a.m., Employee #8 stated the administrator would be at the agency after his 11:30 a.m. meeting at his primary employer. At 1:30 p.m., the surveyors inquired when the administrator would be arriving at the agency as there were multiple issues that needed to be discussed with him. Employee #8 stated she was still trying to reach him. The administrator arrived at the agency at 2:18 p.m. and remained at the agency until the surveyors left at approximately 4:30 p.m. The administrator was available to the surveyors for a total of two hours and 12 minutes. On 12/15/21, the administrator was at the agency upon the surveyors' arrival at 9:05 a.m., left the agency at approximately 9:30 a.m., returned to the agency at 1:38 p.m. and remained there until the surveyors left at approximately 3:00 p.m. The administrator was available to the surveyors for a total of one hour and 52 minutes. On 12/16/21, the administrator was at the agency upon the surveyors' arrival at 8:30 a.m. At 9:08 a.m., he stated he needed to leave the agency to participate in a board meeting at his primary employer and requested the surveyors to email him when we were prepared to exit the survey. At 12:40 p.m., an email was sent to the administrator notifying him the exit conference would be held at the agency at 1:30 p.m. that day. The administrator was not present for the exit conference and sent an email at 1:47 p.m. stating he had just returned from lunch. The administrator was told, via email, the exit conference was completed and to speak with RN #2, who had been the agency personnel present at the exit conference, regarding the survey findings. The administrator was available to the surveyors for a total of 45 minutes.