Every finding on record at Sullivan County Public Health Services Chha

During the re-certification survey on 5/2/22 at 1:00 PM a review of the agency's Emergency Preparedness Plan was conducted. The Governing Authority failed to ensure the agency develop and maintain a comprehensive emergency preparedness program that meets all applicable requirements but not limited to the following elements: E0017 - HHA Comprehensive Assessment in Disaster E0021 – HHA – Procedures for Follow up Staff/Patients E0033 – Methods for Sharing Information E0037 – Emergency Preparedness Training Program

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on the Agency's written Emergency Preparedness Plan dated 6/2019, the Governing Authority failed to develop and implement policies to includes procedures for but not limited to addressing the identified risk within the agency's risk assessment. Failure to ensure the development of policies to includes procedures for addressing the identified risk within the agency's risk assessments as part of the comprehensive assessment, has the potential for negative patient outcomes. The Findings are: On 5/2/22 at 1:00 PM Agency's written Emergency Plan was reviewed. The Emergency Plan titled, "Sullivan County Public Health Services; Public Health Emergency Preparedness and Response Plan (PHEPRP)” has a revised date of 6/2019. There is no documented evidence the plan was reviewed and updated after 6/2019. There is no documented evidence of policy/procedure (instructions) on how the designated staff should address the risk identified during an emergency such as in case of natural or man-made disaster. On 5/3/2022 at 10:00 AM the Acting Director of Patient Services/Deputy Director Of Public Health was interviewed. The Acting Director of Patient Services/Deputy Director of Public Health states, "the Emergency Plan is part of the County, the home care follows the County Emergency Plan". No further explanation was provided.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on the Agency's written Emergency Preparedness Plan dated 6/19, the Governing Authority failed to ensure the development of a policy which includes procedures that complies with Federal and State laws during an emergency for following up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. Failure to ensure the development of a policy which includes procedures for follow-up that complies with Federal and State laws during an emergency, has the potential for negative patient outcomes. The findings are: On 5/2/22 at 1:00 PM Agency's written Emergency Plan was reviewed. The Emergency Plan titled, "Sullivan County Public Health Services; Public Health Emergency Preparedness and Response Plan (PHEPRP)” has a revised date of 6/2019. The Emergency Preparedness Plan lacks a policy which includes procedures that complies with Federal and State laws for follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. On 5/3/2022 at 10:00 AM the Acting Director of Patient Services/Deputy Director Of Public Health was interviewed. The Acting Director of Patient Services/Deputy Director of Public Health states, "the Emergency Plan is part of the County, the home care follows the County Emergency Plan". No further explanation was provided.

Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This STANDARD is not met as evidenced by: Based on the Agency's Emergency Preparedness Plan dated 6/2019, the agency failed to ensure the development of a comprehensive written policy which includes procedures for for the Health Commerce System, that complies with Federal and State laws during an emergency. Failure to ensure the development of a comprehensive written policy which includes procedures for the Health Commerce System that complies with Federal and State laws during an emergency, has the potential for negative patient outcomes. The Findings Are: A request was made for the agency's Health Provider Network policy on 5/2/2022. The agency provided a document titled:" Sullivan County Public Health Services " with a revision date of 5/2018. The policy lacks documentation of the following: Health Commerce policy is reviewed at least annually; Agency's Health Commerce System ( HCS) coverage consistent with hours of operation; Designation by the agency operator of sufficient staff users of the HCS accounts to ensure rapid response to requests for information by the State and/or local Department Of Health; Designation by the agency operator of sufficient staff users of the HCS accounts to ensure rapid response to requests for information by the State and /or local Department of Health; Adherence to the requirements of the HCS contract; Current and complete updates of the Communication Directory reflecting changes that include, but are not limited to general information and personnel role changes as soon as they occur, and at a minimum, reviewed on a monthly basis. On 5/5/2020 at 10:15 AM, The Deputy Director Of Public Health was interviewed and did not provide an explanation for the above findings.

Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (4) A method for sharing information and medical documentation for patients under the [facility's] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility's] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). This STANDARD is not met as evidenced by: Based on the Agency's Emergency Preparedness Plan dated 6/19, the Governing Authority failed to ensure the development of a written policy which includes procedures for methods for sharing information, and medical documentation of patients that complies with Federal and State laws during an emergency. Failure to ensure the development of a written policy which includes procedures for methods for sharing information, and medical documentation of patients that complies with Federal and State laws during an emergency, has the potential for negative patient outcomes. The Findings are: On 5/2/22 at 1:00 PM Agency's written Emergency Plan was reviewed. The Emergency Plan titled, "Sullivan County Public Health Services; Public Health Emergency Preparedness and Response Plan (PHEPRP)” has a revised date of 6/2019. The Emergency Preparedness Plan lacks documentation of written policies and procedures for the following: A method for sharing information, location, and medical documentation for patients under the agency's care, as needed, with other health care providers to maintain the continuity of care. The Emergency Preparedness Plan lacks a written policy which includes procedures for a communication plan that complies with Federal and State during an emergency. On 5/3/2022 at 10:00 AM the Acting Director of Patient Services/Deputy Director Of Public Health was interviewed, and stated: "the Emergency Plan is part of the County, the home care follows the County Emergency Plan". No further explanation was provided.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based the Agency's written Emergency Preparedness Plan dated 6/19, the agency failed to ensure the development and implementation of a policy which includes procedures for Emergency Preparedness training. This was evident for two (2) of eight (8) personnel records reviewed (Employees # 4, and #5) Failure to ensure the development and implementation of a written policy which includes procedures for Emergency Preparedness training, has the potential for negative patient outcomes. The Findings Are: On 5/2/22 at 1:00 PM agency Emergency Plan was reviewed. The Emergency Plan titled, "Sullivan County Public Health Services; Public Health Emergency Preparedness and Response Plan (PHEPRP)” has a revised date of 6/2019. The Emergency Preparedness Plan (EPP) lacks documented evidence of: Procedure for maintaining documentation of the initial and subsequent (at least every 2 years) training for all staff. The specific training completed as well as the methods used for demonstrating knowledge of the training program. 1. Employee #4 has a hire date of 1/2003. 2. Employee #5 has a hire date of 1/30/17. The personnel record for employees # 4 and #5 lack documented evidence of Emergency Preparedness Plan training for 2021 and 2022. The Acting Director of Patient Services/Deputy Director Of Public Health was interviewed on 5/6/2022 at 10:00 AM. The Acting Director of Patient Services/Deputy Director Of Public Health did not provide an explanation.

This Statement Of Deficiencies is the result of a re-certification survey of the Certified Home Health Agency, Sullivan County Public Health Services located at 50 Community Lane, Liberty NY 12754 from 5/2/2022 to 5/6/2022. The Agency reported an active total census of 200 Patients, including three (3) Long Term Home health Care Program Patients. During the survey, seventeen (17) clinical records were reviewed, identified as Patients #1 #2, #3, #5, #9, #10, #13, #15, # 16, and #17, including five (5) discharge records identified as Patients #4, #6, #7, #8 and #14 ; seven (7) observational home visits were conducted identified as Patients # 1, #9, #10, #11, #12, #13, and #15 ; eight (8) personnel records identified as Employees #1, #2, #3, #4, #5, #6, #7, and #8 ; the Quality Assurance and Performance (QAPI) Program; QAPI Committee meeting minutes for the past twelve (12) months; The complaint logs for the years 2021 and 2022; the Emergency Preparedness Plan, the Health Commerce System Policy, the Influenza Vaccination Policy , the Criminal History Record Check Policy, The Home Care Registry Policy, The Covid-19 and Infection Control Policy, the COVID -19 vaccination policy, and the Agency Infection Control Program. Interviews were conducted throughout the survey with the Deputy Director Of Public Health and the Clinical Manager. Findings were reviewed with the Administrator, the Deputy Director Of Public Health, and the Clinical Manager on 5/6/2022. Deficient practices were identified in Condition 42 CFR. Care Planning, Coordination of Services, and Quality of Care 484.60 (a) (2) ( (G0574iii) types of services, supplies and equipment required; (xi) Safety measures to protect against injury. The agency failure to ensure that Patient #1 had safety measures implemented to protect the Patient against injury ,and to ensure that equipment and supplies in the home were used safely and as intended; and that the Plan Of Care was followed in accordance with the patient's needs. Condition Levels Deficiencies were identified in the following Condition Of Participation: 484.60 Condition Of Participation: Care Planning, Coordination of Services and Quality of Care. As a result of these deficient practices, potential negative outcomes were identified for one (1) Patient # 1, and the potential for negative outcomes for the Patients receiving Oxygen Therapy. The agency's actions created an unsafe living environment for the patient and a potential hazard for the community. Immediate Jeopardy was identified, and called on 5/5/2022. The Immediate Jeopardy Template with the following deficiencies was delivered to the Deputy Director of Public Health on 5/5/2022 at 4:43 PM with the following conditions: G- 0574: The Interdisciplinary plan of care must include the following: The type of services, supplies, and equipment required; safety measures to protect against injury. The Agency has submitted the Immediate Jeopardy removal Plan on 5/6/2022 at 4:30PM. The Agency Immediate Jeopardy removal plan was approved after review of the plan on 5/6/2002 at 4:45 PM. The following deficiencies are identified as a result of the survey: E - 0017 - Emergency Preparedness E - 0021 - Emergency Preparedness E - 0029 - E- Emergency Preparedness E - 0033 - Emergency Preparedness E - 0037 - Emergency Preparedness G - 0434 - Participate in Care G- 0570 - Coordination, Care Planning and Quality of Care G - 0578 -Conformance with Physician Orders G - 0586 - Review and Revision of the Plan Of Care G - 0590 - Promptly Alert Relevant Physician of Changes G - 0640 - Quality Assessment and Performance Improvement G - 0642 - Program Scope G - 0644 - Program Data G - 0650 - Incidence, Prevalence, Severity of Problems G - 0654 - Track Adverse Patient Events G - 658 - Performance Improvement Projects G - 660 - Executive Responsibilities G - 0684 - Infection Control G - 0687 - COVID -19 Vaccination J - 1108- Governing Authority L - 0000 - Initial Comments L- 0001 - Unacceptable Infection Control Procedures

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record reviews, policy review and interviews, the Governing Authority failed to ensure that Patients are informed of the services they are to receive, and the frequency for the services, and any related charges. This was evident for four (4) of seventeen(17) clinical records reviewed. (Patients # 3, #5, #7, and #14). Failure to ensure that patients are informed of the services they are to receive, and the frequency of services, and any related charges has the potential of negative patient outcomes. The findings are: The agency's admission packet was reviewed on 5/2/22. The admission packet document a form titled "Plan Of Care Information " with a revision date of 11/2017. The form document spaces for services to be provided and frequency: Skilled nursing, Home health Aide, Physical Therapy, Occupational Therapy, Speech Therapy, Medical Social Worker and medical Supplies. 1. Patient # 3 has a start of care date of 3/1/2022. The form titled " Plan Of Care Information" lacks documented evidence of the patient's name and document under signature" Unable to sign". 2. Patient # 5 has a start of care date of 2/4/2022. The " Home Health Certification and Plan Of Care" document:" Aide 1-2 week for 9 weeks. The form titled" Plan of Care Information" lacks documented evidence the patient was informed about aide services. 3.. Patient # 7 has a start of care date of 1/25/22. 4. Patient #14 has a start of care date 9/5/21. A review of the clinical records lack documented evidence that Patients # 7 and #14 were informed of the disciplines and frequencies of visits they are to receive. On 5/5/22 at 12: 15 PM, the Deputy Director Of Public Health was interviewed and did not provide an explanation for the above findings.

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 record review, home visit, and interview, the agency failed to ensure that care planning, coordination of services, and quality of care was performed on all patients to ensure the HHA can effectively and safely meet the Patient's needs. This was evident for one (1) of seventeen (17) patients. (Patient #1). Failure to ensure that care planning, coordination of services, and quality of care for all patients has the potential for negative patient outcomes. The findings are: Patient #1 has a start of care date of 4/21/22 with diagnoses of Panlobar Emphysema, Diabetes Mellitus Type Two, Hypertension, and Chronic Pain as documented on the Home Health Certification and Plan of Care dated 4/21/22 through 6/1/22. The Home Health Certification and Plan of Care dated 4/21/22 through 6/1/22 documents the Patient is to receive Skilled Nursing visits to assess, monitor and instruct the Patient. The Plan of Care lacks documented evidence of: The development/revision of a complete and comprehensive Plan of Care (G574); Conformance with physicians' orders (G578); Review and Revision of the Plan of Care (G586); Promptly alert the physician of changes (G590). During an interview with the Administrator on 5/5/22 at 12:00 PM, the Administrator did not provide an explanation.

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 clinical record reviews and interview, the agency failed to develop/revise a complete and comprehensive Plan of Care. This was evident for three (3) of seventeen( 17) clinical records reviewed. ( Patients #1, #3, and #7). Failure to develop/ revise a complete a comprehensive Plan Of Care has the potential for negative patient outcomes. The findings are: 1. Patient #1 has a start of care date of 4/21/22 with diagnoses of Pan-lobar Emphysema, Diabetes Mellitus Type Two, Hypertension, and Chronic Pain as documented on the "Home Health Certification and Plan of Care" dated 4/21/22 through 6/1/22. The " Home Health Certification and Plan of Care" for the Certification Period of 4/21/22 through 6/2/22 documents:" Skilled Nurse (SN )visits one to two visits for three weeks than one visit every other week; SN to assess and monitor; Oxygen air delivery systems device three liters by inhalation route continuous; instruct on disease process and home safety; T/R (teach and return) Patient on Oxygen, Oxygen safety; long term goals- Patient will demonstrate ability to maintain safety in the home." A Skilled Nurse visit note dated 4/21/22 documents: "the Patient is short of breath with minimal exertion;, Patient lives alone in elder housing; diminished lung sounds in all lobes"; "Patient continues to smoke despite being dependent on Oxygen"; "T/R Oxygen is supplemental and is considered flammable, avoid open flames, Patient is aware". A home visit observation and interview was made on 5/4/22. The surveyor observed that there was no sign ( Oxygen in Use) posted on the door to the patient's apartment . The Surveyor observed that the patient is using Oxygen via nasal cannula. During the interview ,the Patient stated he smokes four cigarettes' a day and that he removes the Oxygen when he smokes. The Nurse asked the Patient if he turns off the Oxygen, and the Patient stated he does not turn the Oxygen off because the concentrator is in the bedroom, and he does not want to go into the bedroom. The Nurse than asked to move the concentrator into the living room to be closer to where the Patient stays. The Patient was adamant about not moving the concentrator. On 5/5/22, at 10: 30 AM, a request was made for documentation of safety instructions provided to the Patient regarding the safe use of the Oxygen. The agency's policy titled "Oxygen Therapy via Nasal Cannula" with a revision date of 7/2005 documents: "Procedure- not to allow the patient to smoke; Oxygen signs should be posted on all exterior doors; document all teaching performed and the patient's response. " The agency provided a form titled "Safe Oxygen Use Acknowledgement" with a completion date of the form 4/21/22. The form documents: "Do not smoke when Oxygen is in use. If you do smoke, always remove, and turn off your Oxygen; do not store Oxygen concentrator or cylinders near any source of heat. The acknowledgement statement on the form documents: "I understand that if I do not comply with these safety measures, the agency reserves the right to cancel visits or terminate my services". Under the space for the Patient's signature, it is documented" verbal". The Acknowledgement is not signed by the Patient. A note dated 5/4/22 written by the Nurse that made the visit on 4/21/22 documents "I did not have him (the Patient) sign the form due to the pandemic and the need to avoid contamination/contact with myself and the tools I utilize." On 5/5/22 at 12 PM, during an interview with Deputy Director Of Public Health , the Director stated there is a concentrator and an oxygen tank in the Patient's home. There is no documented evidence of a complete medical order for Oxygen, the type of equipment required ( concentrator and/ or tank), the manner in which the Oxygen is to be administered, and the manner in which the Oxygen is to be safely used based on the Patient’s smoking habits. There is no documented evidence of provision of safety instructions to the Patient, and continuous monitoring of compliance for safe use of Oxygen by the Registered Nurse. There is no documented evidence the Plan Of Care is complete and include the equipment and supplies required , and safety instructions to protect the Patient against injury. On 5/5/22 at 12:00PM, the Deputy Director of Public Health Services was interviewed, and stated the nurse should have had the Patient sign the form. No further explanation was provided for the above findings. 2. Patient # 3 has a start of care date 3/1/2022 with diagnosis that include Hypertensive Heart and Chronic Kidney Disease and Stage 1 to Stage 4 Chronic Kidney Disease, Chronic Obstructive Pulmonary Disease, Morbid Obesity Due To Excess Calorie, Type II Diabetes Mellitus with Diabetes Chronic Kidney Disease as documented on the "Home Health Certification and Plan of Care" for the Certification Period of 3/1/2022 to 4/29/2022. The " Home Health Certification and Plan Of Care" for the Certification Period of 3/1/2022 to 4/29/2022 document: "Physical Therapy (PT) once for one day. Perform PT evaluation of the patient in the home setting. Skilled Nurse once for one day Evaluation. Patient/ wife instructed to monitor weight daily and to notify agency/ MD as soon as possible if more weight gain. Both verbalized understanding. Oxygen Concentrator take 2 liters by nasal route intermittent as needed to maintain Oxygen saturation greater than 90%." The record document the following PT visits: 3/3/22, 3/9/22, 3/11/22, 3/14/22, 3/17/22, 3/21/22, 3/24/22, 3/30/22, 4/1/22, 4/6/22, 4/8/22, 4/12/22, 4/19/224/21/22, 4/27/22,4/28/22. There is no documented evidence of Physical Therapy order from 3/3/22 to 4/29/22. The Skilled Nurse OASIS note dated 3/1/22 document: " No oxygen in the home". There is no documented evidence of Oxygen use in the home. There is no documented evidence of an order clarification for the use of Oxygen. There is no documented evidence of Oxygen in use and Oxygen safety instructions during the Physical Therapist visits. There is no documented evidence the Plan Of Care is complete. . 3. Patient # 7 has a start of care date of 1/25/22 and a discharge date of 3/16/22 with diagnosis that include Displaced Bimalleolar fracture of Right Lower Leg, Unspecified Fracture Of Right Tibia, Essential hypertension, as documented on the " Home Health Certification and Plan Of Care" for the Certification Period of 1/25/22 to 3/25/22. The " Home Health Certification and Plan of Care" for the Certification Period of 1/25/22 to 3/25/22 document: Physical Therapy (PT) once for one week. Occupational Therapy (OT) once for one week, Skilled Nurse (SN) once for one week 1-2 times a week for 8 weeks. Assess and monitor CP, CV, GI, GU, Nutritional, Integumentary, mental , emotional , pain, mobility. PT to remain NWB RLE. Report to MD if Blood Pressure < 90/60 or < 150/90. Medications: Hydrochlorothiazide 25 mg tablet every day (QD) oral (PO), Aspirin 81 mg tablet PO QD, Ibuprofen 400 mg tablet every 6 hours as needed, Losartan 50 mg tablet PO QD, Rosuvastatin 5 mg tablet PO QD, Tylenol 325 mg 3 tablets PO every 6 hours as needed, Colace 100 mg tablet twice a day PO, Oxycodone/ Acetaminophen 5 mg- 325 mg tablet one tablet every 6 hours PO as needed.". The record document the following nursing visits: 1/25/22, 2/1/22, 2/7/22, 2/17/22, 3/16/22. The nurse visit note dated 2/17/22: " Patient reports she has a one year history of Diabetes, has been taking Metformin 500 mg oral twice a day for one year. She denies checking her blood sugar (FBS). Patient has good awareness of Diabetes Mellitus and does limit Carb rich foods." The record document the following Physical Therapy visits: 1/26/22, 2/9/22, 3/2/22, 3/4/22, 3/9/22. There is no documented evidence of an order for Metformin on the Plan Of Care. There is no documented evidence the Plan Of care is complete. On 5/5/22 at 12: 15 PM, the Deputy Director of Public Health was interviewed and did not have an explanation for the above findings.

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 observations, record reviews and interviews, the agency failed to ensure that services are provided in accordance with the Plans of Care . This was evident for three (3) of seventeen (17) clinical records reviewed. (Patients #1, #3 and #6). Failure of the agency to ensure patients safety was monitored and ensure the Plans of Care are implemented is likely to place all patients at risk of serious harm and adverse outcome. The findings are: 1. Patient #1 has a start of care date of 4/21/22 with diagnoses of Pan-lobar Emphysema, Diabetes Mellitus Type Two, Hypertension, and Chronic Pain as documented on the" Home Health Certification and Plan of Care" dated 4/21/22 through 6/1/22. The Home Health Certification and Plan of Care" dated 4/21/22 documents: "Skilled Nurse(SN) visits one to two visits for three weeks than one visit every other week; SN to assess and monitor systems and nutritional status; Patient is to check his weight daily and report 2 pound gain in 24 hours or 5 pounds in one week; T/R with Diabetes need to check FBS (Fasting Blood Sugar) two times a day and report less than 70 or greater than 175; Triamcinair 0.5% topical cream two times a day to the left back area; Oxygen air delivery systems device three liters by inhalation route continuous; instruct on disease process and home safety; T/R (teach/repeat) on Oxygen, Oxygen safety, Oxygen-air delivery systems device take 3 liters by inhalation route; Oxygen safety; long term goals- Patient will demonstrate ability to maintain safety in the home." The Skilled Nurse note dated 4/21/22 documents: "the Patient is short of breath with minimal exertion; Patient lives alone in elder housing; diminished lung sounds in all lobes"; "Patient continues to smoke despite being dependent on Oxygen"; "T/R Oxygen is supplemental and is considered flammable, avoid open flames, Patient is aware". The note lacks documented evidence as to whether the Patient is weighing himself daily, and if so, the weights; whether the Patient is monitoring the blood sugar two times a day and the results; whether the Patient is utilizing the Oxygen safely. The SN note dated 4/27/22 documents: Patient is dependent on Oxygen, rhonchi and crackles to the right middle and lower lobes and diminished breath sounds in all lobes; Oxygen 3 liters via nasal cannula; blood glucose 130 random by caregiver. The note lacks documented evidence as to whether the Patient is weighing himself daily, and if so, the weights; whether the Patient is monitoring the blood sugar two times a day and the results; whether the Patient is utilizing the Oxygen safely. There is no documentation in the POC or follow-up with regards to the Patient smoking and the use of Oxygen. A home visit was made on 5/4/22. The Patient resides in a senior housing complex, and it was noted that there is no sign posted on the door to the apartment that Oxygen is in use. The Patient was noted to be using Oxygen via nasal cannula. The Patient stated he smokes four cigarettes' a day and that he removes the Oxygen when he smokes. The Nurse asked the Patient if he turns off the Oxygen and the Patient stated he does not because the concentrator is in the bedroom, and he does not want to go into the bedroom. The Nurse than asked to move the concentrator into the living room to be closer to where the Patient stays. The Patient was adamant about not moving the concentrator. The Patient stated the following: he has not been testing his blood sugar, that he is not able to do it, and a private hire caregiver comes three days a week and tests the blood sugar; he has not been weighing himself daily; he has not been using the Triamcinair 0.5% topical cream two times a day to the left back area as he is not able to reach the area. There is no documentation the POC was revised regarding the blood glucose testing, daily weights, and not using the topical cream. A request was made for documentation that the Patient was given instructions regarding the safe use of the Oxygen. The agency provided a form titled "Safe Oxygen Use Acknowledgement" with a completion date of the form 4/21/22. The form documents: Do not smoke when Oxygen is in use. If you do smoke, always remove, and turn off your Oxygen; do not store Oxygen concentrator or cylinders near any source of heat. The acknowledgement statement documents: "I understand that if I do not comply with these safety measures, the agency reserves the right to cancel visits or terminate my services". The Acknowledgement is not signed by the Patient. A note dated 5/4/22 written by the Nurse that made the visit on 4/21/22 documents "I did not have him (the Patient) sign the form due to the pandemic and the need to avoid contamination/contact with myself and the tools I utilize. During an interview with the Administrator on 5/5/22 at 12:00 PM, the Administrator stated the nurse should have had the Patient sign the form. The agency's policy titled Oxygen Therapy via Nasal Cannula with a revision date of 7/2005 documents: Procedure- not to allow the patient to smoke; Oxygen signs should be posted on all exterior doors; document all teaching performed and the patient's response. There is no documented evidence of follow-up to determine whether there are any problems with and the safe use of the Oxygen. 2. Patient # 7 has a start of care date of 1/25/22 and a discharge date of 3/16/22 with diagnosis that include Displaced Bimalleolar fracture of Right Lower Leg, Unspecified Fracture Of Right Tibia, Essential hypertension, as documented on the " Home Health Certification and Plan Of Care" for the Certification Period of 1/25/22 to 3/25/22. The " Home Health Certification and Plan of Care" for the Certification Period of 1/25/22 to 3/25/22 document: Physical Therapy (PT) once for one week. Occupational Therapy (OT) once for one week, Skilled Nurse (SN) once for one week 1-2 times a week for 8 weeks. Assess and monitor CP, CV, GI, GU, Nutritional, Integumentary, mental , emotional , pain, mobility. PT to remain NWB RLE. Report to MD if Blood Pressure < 90/60 or < 150/90. Medications: Hydrochlorothiazide 25 mg tablet every day (QD) oral (PO), Aspirin 81 mg tablet PO QD, Ibuprofen 400 mg tablet every 6 hours as needed, Losartan 50 mg tablet PO QD, Rosuvastatin 5 mg tablet PO QD, Tylenol 325 mg 3 tablets PO every 6 hours as needed,Colace 100 mg tablet twice a day PO, Oxycodone/ Acetaminophen 5 mg- 325 mg tablet one tablet every 6 hours PO as needed.". The record document the following nursing visits: 1/25/22, 2/1/22, 2/7/22, 2/17/22, 3/16/22. There is no documented evidence of nursing visits the week of 2/20/22 to 2/26/22. There is no documented evidence of nursing visits the week of 3/6/22 to 3/12/22. The record document the following Physical Therapy visits: 1/26/22, 2/9/22, 3/2/22, 3/4/22, 3/9/22. There is no documented evidence of Blood Pressure parameters for physician notification. There is no documented evidence the services were in conformance with physicians' orders. On 5/5/22 at 12: 15 PM, the Deputy Director of Public Health was interviewed and did not have an explanation for the above findings.

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on clinical records review and staff interviews, the Agency failed to ensure that the Plan of Care was updated and revised to reflect the patient's current medications and treatments. This was evident for three(3) of seventeen (17) clinical records reviewed (Patients #15, #16 and #17). Failure to ensure that the Plan of Care is updated and revised has the potential for negative patient outcomes. The findings are: 1. Patient #15 has a start of care date of 1/8/22 with diagnoses of Infection Following Procedure, Peripheral Vascular Disease, and Chronic Pain as documented on the Home Health Certification and Plan of Care dated 3/9/22 through 5/7/22. The Plan of Care dated 3/9/22 documents: SN 1 time a week for 9 weeks to assess and monitor medications and response; Ketoconazole 2% topical two times a day and Triamcinolone Acetonide 0.1% two times a day. During a home visit on 5/4/22, the Patient stated that she stopped using Ketoconazole 2% topical and Triamcinolone Acetonide 0.1% "a long time ago". The record lacks documented evidence of revision to the Plan Of Care. 2. Patient #16 has a start of care date of 4/19/22 with diagnoses of Hypertension, Diabetes Mellitus Type Two, and Osteoarthritis of the Left Shoulder as documented on the Home Health Certification and Plan of Care dated 4/19/22 through 6/17/22. The Plan Of Care dated 4/19/22 documents Skilled Nurse(SN) 1 time for two weeks then every other week for 7 weeks to assess and monitor medications and response; Senna 8.6 mg two tablets every day as needed for Constipation; Colace 100 mg, one tablet two times a day as needed for Constipation. The Skilled Nurse (SN) note dated 4/19/22 documents: "Patient has not had a bowel movement since 4/15/22 and took Miralax; she will have her daughter pick up a stronger laxative if she does not go". There is no documentation as to whether there is Colace or Senna in the home and whether the Patient is using either one. The record lacks documented evidence of revision to the Plan Of Care. 3. Patient #17 has a start of care date of 9/13/19 with diagnoses of Chronic Obstructive Pulmonary Disease, Chronic Pain, and Parkinson’s Disease as documented on the Home Health Certification and Plan of Care dated 4/29/22 through 6/24/22 . The Plan Of Care dated 4/29/22 documents SN every other week to pre-pour medications, Tylenol Arthritis 650 mg, two tablets every 8 hours as needed for pain. The SN note dated 4/20/22 documents the Patient is taking Tylenol 1000 mg every 6 hours for pain. The record lacks documented evidence of revision to the Plan Of Care. During an interview with the Administrator on 5/5/22 at 12:00 PM, the Administrator did not provide an explanation for the above findings.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, clinical record reviews and interview, the agency failed to promptly notify the physician of changes in patients' status which may require alteration in Plans of Care. This was evident for three (3) of seventeen (17) clinical records reviewed. ( Patients #1, #3, and #13). Failure to notify the physician of changes in the patient's status which may require alteration in Plans of care has the potential for negative patient outcomes. The findings are: 1. Patient #1 has a start of care date of 4/21/22 with diagnoses of Pan-lobar Emphysema, Diabetes Mellitus Type Two, Hypertension, and Chronic Pain as documented on the Home Health Certification and Plan of Care dated 4/21/22 through 6/1/22. The Plan of Care dated 4/21/22 through 6/1/22 documents: "SN visits one to two visits for three weeks than one visit every other week; SN to assess and monitor systems and nutritional status; Patient is to check his weight daily and report 2 pound gain in 24 hours or 5 pounds in one week; T/R with Diabetes need to check FBS (Fasting Blood Sugar) two times a day and report less than 70 or greater than 175; Oxygen air delivery systems device three liters by inhalation route continuous; instruct on disease process and home safety; T/R (teach/repeat) on Oxygen, Oxygen safety, Oxygen-air delivery systems device take 3 liters by inhalation route; Oxygen safety; long term goals- Patient will demonstrate ability to maintain safety in the home." The SN note dated 4/21/22 documents: the Patient is short of breath with minimal exertion;, Patient lives alone in elder housing; diminished lung sounds in all lobes; "Patient continues to smoke despite being dependent on Oxygen"; T/R Oxygen is supplemental and is considered flammable, avoid open flames, Patient is aware. " The SN note dated 4/21/22 documents: "Patient continues to smoke despite being dependent on Oxygen". A home visit with observation and interview was conducted on 5/4/22. The Patient resides in a senior housing complex and the surveyor noted that there is no sign ( Oxygen in Use)posted on the door to the Patient's apartment . The Patient was noted to be using Oxygen via nasal cannula. The Patient stated he smokes four cigarettes' a day and that he removes the Oxygen when he smokes. The Nurse asked the Patient if he turns off the Oxygen and the Patient stated he does not because the concentrator is in the bedroom and he does not want to go into the bedroom. The Nurse than asked to move the concentrator into the living room to be closer to where the Patient stays. The Patient was adamant about not moving the concentrator. The Patient was asked if he has tested his blood sugar and the Patient stated he is not able to do it and a private hire person comes three days a week and tests it. There is no documentation of communication with the physician regarding the Patient's non-compliance, and the Patient is not testing the blood sugar two times a day, weighing himself daily and Patient is using of Oxygen while smoking. There is no documentation the agency communicated with other outside agencies regarding the Patient's smoking and unsafe use of Oxygen in the home that could result in serious harm and adverse outcome to the Patient and his surroundings. There is no documented evidence the Physician was notified of the Patient's status non compliance with Oxygen safety, weight and blood sugar compliance ,which may require alterations in the Plan Of Care. During an interview with the Administrator on 5/5/22 at 12:00 PM, The Administrator did not provide an explanation for the above findings. 2. Patient #13 has a start of care date of 2/26/22 with diagnoses of Pressure Ulcer to the Sacrum, Monoplegia of the Left Upper Extremity and Spinal Stenosis as documented on the Home Health Certification and Plan of Care dated 4/27/22 through 6/25/22. The Plan of Care dated 4/27/22 documents :" Skilled Nursing (SN) visits 1 to 3 times a week for 9 weeks; Physical Therapy (PT) 1 to 2 times a week for 8 weeks." The PT documents on 4/7/22 "Patient slid off the recliner and Patient denies injury". A Communication note documents the PT called the Patient's physician and left a message regarding the fall. The record lacks documented evidence of a follow up or response from the physician regarding the fall. During an interview with the Administrator on 5/5/22 at 12:00 PM, The Administrator did not provide an explanation. 1. Patient #1 has a start of care date of 4/21/22 with diagnoses of Pan-lobar Emphysema, Diabetes Mellitus Type Two, Hypertension, and Chronic Pain as documented on the "Home Health Certification and Plan of Care" dated 4/21/22 through 6/1/22. The " Home Health Certification and Plan of Care" dated 4/21/22 through 6/1/22 documents: "SN visits one to two visits for three weeks than one visit every other week; SN to assess and monitor systems and nutritional status; Patient is to check his weight daily and report 2 pound gain in 24 hours or 5 pounds in one week; T/R with Diabetes need to check FBS (Fasting Blood Sugar) two times a day and report less than 70 or greater than 175; Oxygen air delivery systems device three liters by inhalation route continuous; instruct on disease process and home safety; T/R (teach/repeat) on Oxygen, Oxygen safety, Oxygen-air delivery systems device take 3 liters by inhalation route; Oxygen safety; long term goals- Patient will demonstrate ability to maintain safety in the home." The SN note dated 4/21/22 documents: the Patient is short of breath with minimal exertion;, Patient lives alone in elder housing; diminished lung sounds in all lobes; "Patient continues to smoke despite being dependent on Oxygen"; T/R Oxygen is supplemental and is considered flammable, avoid open flames, Patient is aware. " The SN note dated 4/21/22 documents: the Patient is short of breath with minimal exertion;, Patient lives alone in elder housing; diminished lung sounds in all lobes; "Patient continues to smoke despite being dependent on Oxygen"; T/R Oxygen is supplemental and is considered flammable, avoid open flames, Patient is aware. " The SN note dated 4/21/22 documents: "Patient continues to smoke despite being dependent on Oxygen". A home visit with observation and interview was conducted on 5/4/22. The Patient resides in a senior housing complex and the surveyor noted that there is no sign ( Oxygen in Use)posted on the door to the Patient's apartment . The Patient was noted to be using Oxygen via nasal cannula. The Patient stated he smokes four cigarettes' a day and that he removes the Oxygen when he smokes. The Nurse asked the Patient if he turns off the Oxygen and the Patient stated he does not because the concentrator is in the bedroom and he does not want to go into the bedroom. The Nurse than asked to move the concentrator into the living room to be closer to where the Patient stays. The Patient was adamant about not moving the concentrator. The Patient was asked if he has tested his blood sugar and the Patient stated he is not able to do it and a private hire person comes three days a week and tests it. There is no documentation of communication with the physician regarding the Patient's non-compliance, and the Patient is not testing the blood sugar two times a day, weighing himself daily and Patient is using of Oxygen while smoking. There is no documentation the agency communicated with other outside agencies regarding the Patient's smoking and unsafe use of Oxygen in the home that could result in serious harm and adverse outcome to the Patient and his surroundings. There is no documented evidence the Physician was notified of the Patient's status non compliance with Oxygen safety, weight and blood sugar compliance ,which may require alterations in the Plan Of Care. 2. Patient # 3 has a start of care date 3/1/2022 with diagnosis that include Hypertensive Heart and Chronic Kidney Disease and Stage 1 to Stage 4 Chronic Kidney Disease, Chronic Obstructive Pulmonary Disease, Morbid Obesity Due To Excess Calorie, Type II Diabetes Mellitus with Diabetes Chronic Kidney Disease as documented on the "Home Health Certification and Plan of Care" for the Certification Period of 3/1/2022 to 4/29/2022. The " Home Health Certification and Plan Of Care" for the Certification Period of 3/1/2022 to 4/29/2022 document: "Physical Therapy (PT) once for one day. Perform PT evaluation of the patient in the home setting. Skilled Nurse once for one day Evaluation. Patient/ wife instructed to monitor weight daily and to notify agency/ MD as soon as possible if more weight gain. Both verbalized understanding. Oxygen Concentrator take 2 liters by nasal route intermittent as needed to maintain Oxygen saturation greater than 90%. The record document the following skilled nurse visit weights: 3/1/22 OASIS : 317 lbs. The record document the following PT visits: 3/3/22, 3/9/22, 3/11/22, 3/14/22, 3/17/22, 3/21/22, 3/24/22. The PT visit note of 4/28/2022 document: Weight 332 lbs. The last one was 324 lbs. There is no documented evidence of review of the Patient's weight by the Physical Therapist during the visits. There is no documented evidence of changes in the patient's weights to alert the Physician which may require alteration in the Plan Of Care. On 5/5/22, at 12:00PM. the Deputy Director of Public Health was interviewed and did not provide an explanation for the above findings. 3. Patient #13 has a start of care date of 2/26/22 with diagnoses of Pressure Ulcer to the Sacrum, Monoplegia of the Left Upper Extremity and Spinal Stenosis as documented on the "Home Health Certification and Plan of Care" dated 4/27/22 through 6/25/22. The " Home Health Certification and Plan of Care" dated 4/27/22 documents :" Skilled Nursing (SN) visits 1 to 3 times a week for 9 weeks; Physical Therapy (PT) 1 to 2 times a week for 8 weeks." The PT documents on 4/7/22 "Patient slid off the recliner and Patient denies injury". A Communication note documents the PT called the Patient's physician and left a message regarding the fall. There is no documented evidence of a follow up or response from the physician regarding the fall. There is no documented evidence the Physician was notified of the changes in the Patient's status which may require alterations in the Plan Of Care. During an interview with the Administrator on 5/5/22 at 12:00 PM, The Administrator did not provide an explanation for the above findings. During an interview with the Administrator on 5/5/22 at 12:00 PM, The Administrator did not provide an explanation for the above findings.

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, Quality assessment and performance improvement (QAPI) meeting minutes and interview, the Governing Authority failed to develop, implement, evaluate, and maintain an effective, ongoing, agency-wide, data-driven QAPI program. This was evident for the QAPI meeting minutes for 2021 and 2022 reviewed. Failure to ensure the development, implementation, evaluation, and maintenance of an effective, ongoing, HHA-wide, data-driven QAPI program has the potential for negative patient outcomes. The findings are: A request was made on 5/2/22 for the agency's Quality Assessment and Performance Improvement (QAPI) meeting minutes for 2021 and 2022 and the agency's policy related to QAPI. The agency provided the following QAPI meeting minutes dated 2/9/21, 4/20/21, 5/25/21, 9/29/21, and 3/1/22. A review of the Quality Assessment and Performance Improvement (QAPI) minutes and interviews with agency staff, the HHA was unable to show that they measured, analyzed, and tracked quality indicators, including adverse patient events and other aspects of performance. The lack of measuring, analyzing, and tracking quality indicators has the potential for the agency to be unable to assess processes of care, HHA services, and operations. The agency's policy titled “Quality Improvement” has a revision date of 6/2014. The policy documents that activities of the Professional Advisory Committee include: Review a sample of both active and discharged patient records to determine whether established policies are being followed; Reviews complaints, and if necessary, makes recommendations to improve patient care; Review policies pertaining to the delivery of the health care and services provided by the agency; Make recommendations on professional issues; Participate in annual evaluation of the agency's home health care program. The policy lacks documented evidence of revision to include the utilization of quality indicator data, including measures derived from OASIS data. The QAPI meeting minutes lack documented evidence of: The development of measurable improvement indicators for clinical record reviews measuring, tracking, and analyzing of patient adverse events (G642); Program Data to include utilization of quality indicator data, including data derived from OASIS (G644); Audits are conducted to monitor the incidence, prevalence, and severity of problems (G650); The tracking of adverse patient events (G654); Develop and perform quality improvement projects (G658). During an interview with the Administrator on 5/5/22 at 12:00 pm, the Administrator stated, “I know we are not where we need to be”.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record reviews and staff interviews, the Governing Authority failed to ensure the development of measurable improvement indicators for clinical record reviews that are to be conducted by the Professional Advisory Committee (PAC). Failure to ensure measurable improvement in indicators for clinical record reviews has the potential risk for negative patient outcomes. The findings are: The Professional Advisory Committee and Performance Improvement Committee Meeting Minutes for the 2021 and 2022 lack documented evidence of clinical records being reviewed to include performance improvement indicators, analysis, and tracking of quality indicators of the collected data. There is no documented evidence that the agency is able to show areas in need of improvement and measurable improvements, which will improve health outcomes, patient safety, and quality of care. On 5/5/22 at 12:00 PM, the Administrator was interviewed, and did not provide an explanation for the findings.

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 reviews and staff interviews, the Governing Authority failed to ensure the utilization of quality indicators from OASIS and other relevant data collected by the Professional Advisory Committee (PAC). Failure to ensure the utilization of quality indicators from OASIS and other relevant data collected by the PAC, has the potential risk for negative patient outcomes. The findings are: The Professional Advisory Committee and Performance Improvement Committee Meeting Minutes for 2021 and 2022 lack documentation of the review OASIS audits conducted by the agency. During an interview with the Administrator on 5/5/22 at 12:00 PM, the Administrator did not provide an explanation for the above.

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on record review and interview, the Governing Authority failed to ensure that audits are conducted to monitor the incidence, prevalence, and severity of problems areas. Failure to ensure audits are conducted to monitor the incidence, prevalence, and severity of problem areas has the potential for problems to not be identified and actions taken to correct and prevent the issues resulting in the risk for negative patient outcomes. The findings are: A review of the QAPI meeting minutes for 2021 and 2022, the minutes lack documented evidence audits were conducted to monitor the incidence, prevalence, and severity of problems areas. During an interview with the Administrator on 5/5/22 at 12:00 PM, the Administrator did not provide an explanation for the above.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on record review and interview, the Governing Authority failed to conduct performance improvement activities and track adverse patient events, analyze their causes, and implement preventive actions. Failure to track adverse patient events, analyze the causes, and implement prevent actions has the potential for negative patient outcomes. The findings are: The Professional Advisory Committee and Performance Improvement Committee Meeting Minutes for 2021 and 2022 were reviewed and lack documented evidence that adverse patient events are being tracked, analyzed for the cause and implemented to prevent re-occurrences. During an interview with the Administrator on 5/5/22 at 12:00 PM, the Administrator did not provide an explanation for the above.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the Governing Authority failed to document quality improvement projects are being performed, with the reasons for conducting these projects, and the measurable progress achieved on these projects. Failure to document the quality improvement projects the agency is performing has the potential for negative patient outcomes. The findings are: The Professional Advisory Committee and Performance Improvement Committee Meeting Minutes for 2021 and 2022 were reviewed and lack documented evidence the Governing Authority developed quality improvement projects to include measurable progress achievements for these projects. During an interview with the Administrator on 5/5/22 at 12:00 PM, the Administrator did not provide an explanation for the above.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record reviews and staff interviews, the Governing Authority failed to ensure that the quality improvement and patient safety program is defined, implemented, and maintained. Failure to ensure that the quality improvement and patient safety program is defined, implemented, and maintained, has the potential risk for negative patient outcomes. The Findings Are: The Professional Advisory Committee and Performance Improvement Committee Meeting Minutes for the calendar year of 2021, lacks documentation of OASIS audits for Start of Care, Re-certifications, and Discharged patients; performance improvement indicators, analysis, and tracking of quality indicators of the collected data from the audits conducted by the agency. There is no documented evidence that the quality improvement and patient safety program is defined, implemented, and maintained, which will increase improved health outcomes, patient safety, and quality of care. On 5/5/2022 at 12:00PM, the Deputy Director of Public Health was interviewed, and did not provide an explanation for the above findings.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record reviews and staff interviews, the Governing Authority failed to ensure that the quality improvement and patient safety program included, implemented, and maintained an Infection Control Program. Failure to ensure that the quality improvement and patient safety program includes, implements, and maintains an Infection Control Program, has the potential risk for negative patient outcomes. The findings are: On 5/3/2022, The Professional Advisory Committee and Performance Improvement Committee Meeting Minutes for the calendar year of 2021, lacks documentation of the identification, prevention, control, monitoring, and investigation of infectious and communicable diseases . The QAPI minutes were reviewed on 5/3/2022. There is no documented evidence of surveillance program to identify, investigate and control infections or transmissions of communicable disease specific to care/ services provided in the home setting; There is no documented evidence of Method of identifying infectious and communicable diseases problems; There is no documented evidence of a plan for the appropriate actions that are expected to result in improvements and disease prevention; There is no documented evidence of development and review of written Tuberculosis policy, COVID- 19 policy and COVID-19 vaccination policy. On 5/5/2022, at 11:15 AM, the Deputy Director was interviewed and did not provide an explanation for the above findings.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on policy review and staff interview, the Governing Authority failed to develop a comprehensive written policy for COVID-19 to ensure that all staff are fully vaccinated. Failure to develop a comprehensive written policy for COVID-19 to ensure that all staff are fully vaccinated have the potential for negative patient outcomes. The findings are: On 5/4/22 at 10: 30 AM, a request was made for the COVID 19 vaccination policy. This information was not received. There is no documented evidence the agency developed a written COVID 19 vaccination policy. On 5/5/22, at 12:30 PM, the Deputy Director of Public Health was interviewed and did not provide an explanation..