Every finding on record at Crystal Home Healthcare

On September 6, 2022, through September 8, 2022, an Emergency Preparedness survey was conducted by the Michigan Department of Licensing and Regulatory Affairs. During the survey, Crystal Home Health Care was found to be not in compliance with the requirements for participation in Medicare at 42 CFR 484.102 Emergency Preparedness. The following condition level deficiency was identified: 42 CFR §484.102 Emergency Preparedness

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness plan based on both an agency-based and community-based risk assessment (See E0006); failed to develop written emergency preparedness policies and procedures that were based on an emergency preparedness plan, risk assessment, and communication plan (See E0013); failed to develop and maintain an Emergency Preparedness communication plan that complies with Federal, State, and local laws (See E00029); and failed to develop and maintain an Emergency Preparedness training and testing program that is based on the emergency plan, risk assessment, policies, procedures, and communication plan. These deficient practices have the potential to negatively affect the health and safety of the agency's current 11 patients. Findings include: The cumulative effect of these systemic problems results in the agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR 484.102, Emergency Preparedness.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness plan centered on both agency-based and community-based risk assessments, resulting in a lack of direction and duties for agency personnel in the event of an actual disaster. This deficient practice has the potential to negatively affect the health and safety of the agency's current 11 patients. Findings include: On 9/6/22, the agency's Emergency Preparedness information was requested. The agency provided documentation for review that included the agency's emergency preparedness policy and documentation of staff participation in emergency training and drills. The agency's policy titled, Emergency Disaster Management Plan, provides detailed instructions for the agency to follow to create a plan. There is no documentation to indicate the agency did create their own emergency plan. There is no documentation of an agency-based and community-based risk assessment which is required in the development of the agency's emergency plan. During an interview on 9/7/22 at 10:45 a.m., the alternate administrator (Adm#2) reviewed the findings and acknowledged that a risk assessment has not been utilized to create the agency's emergency disaster plan. The agency did not develop an emergency preparedness plan based on both agency-based and community-based risk assessments.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] 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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility 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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop written emergency preparedness policies and procedures that were based on an emergency preparedness plan, risk assessment, and communication plan. Resulting in the agency's inability to implement appropriate emergency actions. This deficient practice has the potential to negatively affect the health and safety of the agency's current 11 patients. Findings include: On 9/6/22 and 9/7/22, the agency's Emergency Preparedness documentation was reviewed. During the review, it was noted that there was no documented evidence of emergency preparedness policies and procedures that were based on an emergency preparedness plan, a documented risk assessment, and communication plan. The agency's policy titled, Emergency Disaster Management Plan, provides detailed instructions for the agency to follow to create a plan. There is no documentation to indicate the agency developed an emergency plan therefore, the agency's policies were not developed based on their emergency plan. During an interview on 9/7/22 at 10:45 a.m., the alternate administrator (Adm#2) reviewed the findings and acknowledged that the agency purchased their emergency policy from a consultant and failed to develop their own policies and procedures utilizing the information from the consultant.

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 record review and interview, the agency failed to develop and maintain an Emergency Preparedness communication plan that complies with Federal, State, and local laws, resulting in the agency's inability to ensure the coordination of patient care in the event of an actual emergency. This deficient practice has the potential to negatively affect the health and safety of the agency's current 11 patients. Findings include: On 9/6/22 and 9/7/22, the agency's Emergency Preparedness documentation was reviewed. During the review, it was noted that the agency had a list of a few local phone numbers however, there was no evidence a communication plan had been developed for the agency to utilize during an emergency. The alternate administrator (Adm#2) was unable to produce a communication or phone tree that detailed the agency's plan to communicate with staff. There was no documentation of a communication plan to indicate how the agency would interact and coordinate with staff, patients, and emergency management agencies to protect patient health and safety in the event of a disaster. The findings were reviewed with and acknowledged by Adm#2 during an interview on 9/7/22 at 10:45 a.m.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an Emergency Preparedness training and testing program that is based on the emergency plan, risk assessment, policies, procedures, and communication plan. Resulting in the agency's in ability to ensure staff actions align with the emergency plan. This deficient practice has the potential to negatively affect the health and safety of the agency's current 11 patients. Findings include: On 9/6/22 and 9/7/22, the agency's Emergency Preparedness documentation was reviewed. During the review, it was noted that the agency conducted a tabletop drill for a winter storm and a fire drill on 1/18/19. It was unclear how the agency could conduct a tabletop drill without first creating an emergency preparedness plan based on a risk assessment, policies, procedures, and communication plan. During an interview on 9/7/22 at 10:45 a.m., the alternate administrator (Adm#2) discussed the patient disaster priority (class 1, 2, or 3) assigned to each patient that determines the immediacy of patient care during an emergency. Adm#2 explained that each patient is assigned a disaster priority level at the time of admission. Adm#2 was asked to provide a list of agency patients regarding their disaster priority level. Adm#2 acknowledged that she has seen that the software utilized by the agency is able to run a disaster priority list, but she is unfamiliar with the process. Adm#2 was unable to identify which patients would need priority care during a disaster. The agency did not have an emergency preparedness plan. The agency did not maintain an emergency preparedness training and testing program based on the emergency plan, risk assessment, policies, procedures, and communication plan.

The following Condition and Standard level deficiencies were identified during a Medicare authorized Recertification survey concurrent with the QSO 22-07-ALL Vaccine Mandate review, conducted by the Michigan Department of Licensing and Regulatory Affairs on 9/6/22 through 9/8/22 at: Crystal Home Health Care 15819 Schoolcraft Rd. Detroit, MI 48227 Services Provided: Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), Medical Social Work (MSW), Speech Therapy (ST). This Agency had no additional locations. Records: 3 records with home visits, 5 records without home visits, for a total of 8 records reviewed. At the conclusion of the survey, the following Condition level deficiencies were identified: 42 CFR §484.55 Comprehensive Assessment of Patients. 42 CFR §484.60 Care Planning, Coordination of Services, and Quality of Care. 42 CFR §484.102 Emergency Preparedness. 42 CFR §484.65 Quality Assessment and Performance Improvement 42 CFR §484.70 Infection Control As a result of the condition level noncompliance, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR 484.80(f)(3).

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and history of events leading to current home care needs; and fails to reflect the patient's current health status in 3 of 8 records reviewed (MR#s 5, 6, 7), resulting in incomplete clinical information to aide in determining the needs of the patient (G526); failed to ensure the patient's needs were met for 1 (MR #1) of 1 patient who required Skilled Nursing services, and 1 (MR #2) of 1 patient who required Occupational Therapy services, from a total of 8 sampled records reviewed, resulting in unaddressed/untreated health concerns and unmet care needs (G534); failed to ensure a registered nurse conducted a review of the patient's medications for any potential adverse effects such as: side effects, drug interactions, and duplicate drug therapy for 5 of 8 (MR# 1, 2, 3, 4, 8) records reviewed, resulting in the potential for harmful medication effects for these patients (G536); failed to ensure the comprehensive assessment was updated and revised for 2 of 2 (MR #2, #8) records reviewed in which patients were transferred to the hospital or care was resumed after a hospital stay, resulting in lack of information in determining the patient's care and support needs (G544); failed to ensure the Resumption of Care Comprehensive Assessment was conducted within 48 hour of the patient's return home post hospitalization in 1 (MR #2) of 2 patients who resumed care under the Agency's services, from a total of 8 sampled patients reviewed, resulting in delay in needed care and services and the potential for unmet care needs (G548); failed to ensure the Comprehensive Assessment was updated and completed at the time of discharge from the Agency's services in 1 (MR #1) 2 discharged records, from a total of 8 sampled records reviewed, resulting in no indication of the patient’s progression towards their identified goals and the potential for unmet continuing care needs (G550). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation at 42 CFR 484.55 Comprehensive Assessment of Patients.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to conduct a patient-specific, comprehensive assessment that accurately reflected the patient's current health status based on past medical history that included dates of onset, exacerbations, treatments and outcomes, and history of events leading to current home care needs; and fails to reflect the patient's current health status in 3 of 8 records reviewed (MR#s 5, 6, 7), resulting in incomplete clinical information to aide in determining the needs of the patient. Findings included: MR #5: The SOC was dated 5/3/22. The Plan of Care (POC) identified the diagnoses of hypertension, heart failure, and diabetes mellitus. A review of the Comprehensive Assessment (OASIS) on 9/6/22, documented under the category of (M1021): "Patient Diagnoses", the only information provided was a list of 7 diagnoses, all having the same onset and exacerbation date. There was no information about the onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. There was no aditional information under each systems assessment. MR #6: The SOC was dated 1/21/22. The POC identified the diagnoses of sciatica, heart failure, asthma, and diabetes mellitus. A review of the Recertification Assessment (OASIS) on 9/7/22, documented under the category of (M1021): "Patient Diagnoses", the only information provided was a list of 9 diagnoses, all having the same onset and exacerbation date. There was no information about the onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. There were no dates of onset, treatments or current patient knowledge under the individual cardiac and pulmonary systems assessments. MR #7: The SOC was dated 7/27/22. The POC identified the diagnoses of embolism, chronic obstructive pulmonary disease (COPD), and pressure ulcers. A review of the Comprehensive Assessment (OASIS) on 9/7/22, documented under the category of (M1021): "Patient Diagnoses", the only information provided was a list of 6 diagnoses, all having the same onset and exacerbation date. There was no information about the onset, exacerbations, prior treatments and outcomes, or history of how the above illnesses/events led to the need for the current home care admission. The individual pulmonary assessment section documented, "No history" when the patient has a diagnosis of COPD. During an interview on 9/8/22 at 11:45 a.m., the alternate administrator (Adm #2) and the clinical manager (CM #1) acknowledged the above findings. .

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the patient's needs were met for 1 (MR #1) of 1 patient who required Skilled Nursing services, and 1 (MR #2) of 1 patient who required Occupational Therapy services, from a total of 8 sampled records reviewed, resulting in unaddressed/untreated health concerns and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 3/10/22 with diagnoses that included Congestive Heart Failure and Hypertensive Heart Disease. During the record review on 9/6/22 at 12:22 p.m., it was noted that the referral for home care dated 3/4/22 ordered Occupational Therapy (OT) and Physical Therapy (PT) services to be provided. During the record review, it was noted that the patient had health concerns that required SN oversight such as, Complaints of persistent pain at reported levels of 6/10, 7/10 and 8/10; Documentation of the patient requiring wound care; Documentation of the patient experiencing weeping (draining), pain and swelling to her lower extremities. Continued review of the clinical record revealed that Skilled Nursing had not been assigned to assess the patient's health condition. The patient was subsequently discharged from the Agency's services on April 2, 2022 by Physical Therapy. These findings were reviewed with and acknowledged by the Assistant Administrator (Adm #2) and the Clinical manager (CM #1) during an interview on 9/7/22 at 1:51 p.m. Adm #2 reported, "That's an organizational thing that we have to look at. Nursing should have been ordered to address these issues." MR #2: The patient's SOC was 8/10/22 with diagnoses that included Hypertension, Diabetes Mellitus, Fracture 3rd Lumbar Vertebra and Fractured Toe. During the clinical record review on 9/7/22 at 3:18 p.m., it was noted that the referral for home care dated 8/4/22, ordered Skilled Nursing (SN), Occupational Therapy (OT) and Physical Terapy (PT) services to be provided. Further review of the record revealed that OT services had not been provided. On 9/8/22 at 9:21 a.m., Adm #2 and CM #1 were queried as to why the ordered services had not been provided, to which Adm #2 replied, "We didn't have coverage in that area. The OT refused to work in that particular area so we notified the doctor and told them we couldn't accept the patient. They changed the order and removed OT so we accepted the patient." The Agency failed to ensure the patient's Occupational Therapy needs were met.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure a registered nurse conducted a review of the patient's medications for any potential adverse effects such as: side effects, drug interactions, and duplicate drug therapy for 8 of 8 (MR# 1, 2, 3, 4, 5, 6, 7, 8) records reviewed, resulting in the potential for harmful medication effects for these patients. Findings include: MR #1: The patient's Start of Care (SOC) was 3/10/22 with diagnoses that included Congestive Heart Failure and Hypertensive Heart Disease. During the clinical record review on 9/6/22 at 12:22 p.m., it was noted that the "Physical Therapy Adult Assessment" dated 3/10/22, completed by the Physical Therapist did not include a section that addressed the Medication review. The "Medication Profile" dated 3/10/22 asked: Potential drug reactions/adverse effects, Significant side effects, Interactions, Duplicate drug therapy, all of which were answered "No" by the Physical Therapist. The patient’s 8 prescribed medications were entered in "Drugs.com (online drug interaction checker) and revealed 1 major drug to drug interaction, 4 drug to food interactions and 4 moderate drug to drug interactions. There was no documented evidence that the Drug Review conducted by the Physical Therapist, was reviewed by the Registered Nurse in accordance with this requirement. These findings were reviewed with and acknowledged by the Assistant Administrator (Adm #2) and the clinical Manager (CM #1) during an interview on 9/7/22 at 1:51 p.m. CM #1 reported, "I didn't know this had to be done." MR #2: The patient's SOC was 8/10/22 with diagnoses that included Hypertension and Diabetes Mellitus. During the record review on 9/7/22 at 3:18 p.m., it was noted that the "Adult Assessment" dated 8/10/22, completed by the Registered Nurse (RN #1) failed to address any Medication interactions or Physician notification. The patient's 19 prescribed medications were entered in Drugs.com and revealed 3 major drug to drug interactions, 29 moderate drug to drug interactions, 9 drug to food interactions and 2 duplicate drugs. The Medication Profile documented: No interactions/adverse effects, No significant drug interactions, No duplicate drug therapy. There was no drug interaction report available for review that provided evidence that the required drug review was conducted at the SOC. Further, there was no documented evidence that the Physician had been made aware of the untoward findings. These findings were reviewed with and acknowledged by Adm #2 and Cm #1 during an interview on 9/8/22 at 9:21 a.m. MR#8: This patient was admitted to the agency on 3/16/22 with diagnoses of hypertensive heart disease, heart failure, and left-sided hemiplegia (paralysis/weakness). The patient was twice recertified for home care services. The period reviewed during the survey was from 7/13/22 through 9/7/22 and the patient was receiving twice weekly physical therapy (PT) visits. During record review on 9/8/22, it was noted that the medication profile for the most recent certification period (7/14/22 through 9/11/22) was not signed by the physical therapist or a registered nurse. There was no indication that the patient's medications had been reviewed for any potential adverse effects such as: side effects, drug interactions, and duplicate drug therapy. The patient was transferred to the hospital on 9/1/22 for right lower extremity swelling due to a blood clot. The resumption of care was ordered by the physician on 9/7/22. During a joint surveyor home visit with the physical therapy assistant (PTA#1) on 9/7/22 at 4:00 p.m., it was observed that the patient was on the following new medications since discharge from the hospital: Prednisone and Gabapentin. There was no evidence that the PT was aware of the updates to the patient's medications and no indication that the medications had been reviewed by a registered nurse for any potential side effects, drug interactions, or duplicate drug therapy. The findings were reviewed with and acknowledged by Adm#2 (alternate administrator) and CM#1 (clinical manager) during an interview on 9/8/22 at 1:00 p.m. MR#3: This patient was admitted to the agency on 8/3/22 with diagnoses of generalized muscle weakness. The comprehensive assessment was conducted by the physical therapist (PT#1) on 8/3/22. Record review on 9/7/22 indicates the patient's medications were reviewed by PT#1. There was no documented evidence that the patient's medications had been reviewed by a registered nurse (RN). On 9/7/22, a drug interaction report was generated utilizing the website, Drugs.com. The drug interaction report indicates there is a potential major interaction between the patient's Codeine + Methocarbamol. The report also indicates the patient is on duplicate non-insulin diabetic medications that include Metformin, Rybelsus, and Jardiance. During an interview on 9/8/22 at 12:30 p.m., Adm#2 and CM#1 confirmed that the list of medications was not reviewed by an RN. MR#4: This patient was admitted to the agency on 8/1/22 with diagnoses of pancreatic cancer and heart failure. During record review on 9/6/22, it was noted that the 8/1/22 comprehensive assessment completed by the registered nurse (RN#2) indicates no issues were found during the drug regimen review. On 9/6/22, a drug interaction report was generated utilizing the website, Drugs.com. The drug interaction report indicates there are two potential major interactions between the patient's Dexamethasone + Oxycodone and between Oxycodone + Zyprexa. There was no documentation to indicate RN#2 was aware of the potential interactions and informed the physician. The findings were reviewed with and acknowledged by Adm#2 and CM#1 during an interview on 9/8/22 at 12:45 p.m. MR#5: The start of care (SOC) was dated 5/3/22, with diagnoses that included hypertension (HTN), heart failure, and diabetes. During record review on 9/6/22, it was discovered that no medication reconciliation was documented in the record. The medication profile documented no potential drug reactions, no adverse effects, no significant side effects, and no significant drug interactions. A medication reconciliation performed on Drugs.com on 9/6/22, found 7 major, 33 moderate, 7 minor, 6 food, and 2 drug duplications. MR #6: The SOC was dated 1/21/22. The POC identified the diagnoses of sciatica, heart failure, asthma, and diabetes mellitus. During record review on 9/7/22, it was discovered that no medication reconciliation or medication profile was documented in the record. A medication reconciliation performed on Drugs.com on 9/7/22, found 4 major, 34 moderate, 6 minor, 10 food, and 4 drug duplications. MR #7: The SOC was dated 7/27/22. The POC identified the diagnoses of embolism, chronic obstructive pulmonary disease (COPD), and pressure ulcers. During record review on 9/7/22, it was discovered that the medication profile had a blank drug regimen review. During an interview on 9/8/22 at 11:45 a.m., the alternate administrator (Adm #2) and the clinical manager (CM #1) acknowledged the findings.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the Agency failed to ensure the comprehensive assessment was updated and revised for 2 of 2 (MR #2, #8) records reviewed in which patients were transferred to the hospital or care was resumed after a hospital stay, resulting in lack of information in determining the patient's care and support needs. Findings include: MR #2: The patient's SOC was 8/10/22 with diagnoses that included Hypertension, Diabetes Mellitus, Fracture 3rd Vertebra and Fractured Toe. During the clinical record review on 9/7/22 at 3:18 p.m., it was noted that the patient was transferred to the hospital on 9/2/22. The "Oasis Transfer Non-Visit" Assessment completed by the Registred Nurse (RN #1) was noted to be incomplete in areas such as: "M0080/Discipline of person completing assessment was blank. M1041-M1056/Influenza and Pneumococcal Vaccine status was left blank. Section M2005/Medications was blank. Falls/J1800 was blank, Emergent Care/M2301 was left blank. Section M2401/Intervention Synopsis was left blank. Section M2410/To which Inpatient Facility has the patient been admitted? was left blank. The sections of the assessment titled: Transfer Summary, Services provided, Medications patient is on at transfer, condition at transfer... were all left blank. Additionally, the section that addressed if the summary was sent to the Physician was left unchecked. There was no documented evidence that a Transfer Oasis had been completed in accordance with this requirement. These findings were reviewed with and acknowledged by Adm #2 and CM #1 during an interview on 9/8/22 at 9:21 a.m. MR#8: This patient was admitted to the agency on 3/16/22 with diagnoses of hypertensive heart disease, heart failure, and left-sided hemiplegia (paralysis/weakness). During record review on 9/8/22, it was noted that the patient was transferred to the hospital on 9/1/22 and was receiving only physical therapy services at the time of transfer. On 9/7/22, the physician ordered physical therapy to resume care after an inpatient stay for swelling/blood clot in right lower extremity. The hospitalization for the leg swelling/blood clot are a marked worsening of the patient's condition. The comprehensive assessment must be updated and revised to reflect the current condition of the patient's health status, care, and support needs. On 9/7/22, physical therapy care was resumed by PTA#1 (physical therapy assistant). There was no documented evidence that the physical therapist conducted a comprehensive assessment of the patient post hospitalization as ordered by the physician.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on observation, interview and record, the Agency failed to ensure the Resumption of Care Comprehensive Assessment was conducted within 48 hour of the patient's return home post hospitalization in 1 (MR #2) of 2 patients who resumed care under the Agency's services, from a total of 8 sampled patients reviewed, resulting in delay in needed care and services and the potential for unmet care needs. Findings include: MR #2: The patient's start of care was 8/10/22 with diagnoses that included Hypertension, Diabetes Mellitus and Fractured toe. During the record review on 9/7/22 at 3:18 p.m., it was noted that the referral for home care dated 8/4/22 ordered Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. During the review, it was noted that the patient was transferred to the hospital on 9/2/22 and returned to home on 9/4/22. On 9/7/22 at 11:00 a.m., during a scheduled home visit with the Registered Nurse (RN #1), it was revealed that this visit would be the Resumption of Care (ROC) visit. RN #1 was queried as to why the visit was not conducted within 48 hours of the patient's return home from the hospital and reported, "This was a holiday weekend." Further review of the clinical record revealed no documented evidence of the patient's decline to be seen within 48 hours of her return home or any rationale for the delay. These findings were reviewed with and acknowledged by the Assistant Administrator (Adm #2) and the clinical Manager (CM #1) during an interview on 9/8/22 at 9:21 a.m.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Comprehensive Assessment was updated and completed at the time of discharge from the Agency's services in 2 (MR #1, 5) of 2 discharged records, from a total of 8 sampled records reviewed, resulting in no indication of the patient’s progression towards their identified goals and the potential for unmet continuing care needs. Findings include: MR #1: The patient's start of care (SOC) was 3/10/22 with diagnoses that included Congestive Heart Failure and Hypertensive Heart Disease. On 9/6/22 at 12:22 p.m., during the clinical record review, it was noted that the patient was ordered to receive Physical Therapy (PT) and Occupational Therapy (OT) services. The patient was discharged from OT services on 3/24/22 and was discharged from the Agency's services by the Physical Therapist on 4/2/22. At the time of this reivew, no Discharge Oasis (Comprehensive Assessment) had been completed as per this requirement. The Assistant Administrator (Adm #2) and Clincal Manager (CM #2) were both queried as to the whereabouts of the Discharge Oasis Assessment during an interview on 9/7/22 at 1:51 p.m., to which both replied, "We don't do a Discharge Oasis/Assessment on HMO Medicaid Molena patients because it's not required." Adm #2 and CM #1 were both made aware of the CMS requirement: "The comprehensive assessment and OASIS data collection requirements apply to Medicare certified home health agencies (HHAs) and to Medicaid home health providers in States where those agencies are required to meet the Medicare Conditions of Participation. The comprehensive assessment requirement currently applies to all patients regardless of pay source, including Medicare, Medicaid, Medicare managed care (now known as Medicare Advantage), Medicaid managed care, and private pay/including commercial insurance." MR#5: The start of care (SOC) was dated 5/3/22, with diagnoses that included hypertension (HTN), heart failure, and diabetes. This patient had orders for skilled nursing (SN) services. During record review on 9/6/22, it was discovered that no discharge OASIS was documented in the record. The patient was discharged on 5/27/22. During an interview on 9/8/22 at 11:45 a.m., the alternate administrator (Adm #2) and the clinical manager (CM #1) acknowledged the 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 and interview, the agency failed to ensure the plan of care included reportable parameters, safety precautions, and measurable outcomes and goals in 6 of 8 records (MR # 3, 4, 5, 6, 7, 8) reviewed. (G-574); failed to ensure services were provided in accordance with a physician's order in 1 of 8 records (MR #6) reviewed. (G-580); and failed to ensure the physician was promptly notified in 2 records (MR's #1, 2) reviewed. (G-590). The cumulative effect resulted in the agency's inability to provide in-home healthcare efficiently.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care included reportable parameters, safety precautions, and measurable outcomes and goals for 6 of 8 (MR# 3, 4, 5, 6, 7, 8) records reviewed, resulting in the potential for poor patient outcomes due to a lack of safety precautions, and quantifiable measures to determine patient progress towards goals. Findings include: MR#3: This patient was admitted to the agency on 8/3/22 with diagnoses of aftercare following a craniotomy for a brain tumor. The 8/3/22 plan of care ordered weekly physical therapy services for this patient. The comprehensive assessment was conducted by the physical therapist (PT#1) on 8/3/22. During record review on 9/7/22, it was noted that PT#1 documented that the patient rated her pain at an 8 (scale 1 low to 10 high) for her right hip, low back, and neck. There was no indication that the plan of care included parameters by which to notify the physician regarding excessive pain for this patient. During an interview on 9/8/22 at 12:30 p.m., the clinical manager (CM#1) acknowledged that the plan of care should contain reportable pain parameters. MR#4: This patient was admitted to the agency on 8/1/22 with diagnoses of pancreatic cancer and heart failure. During record review on 9/6/22, it was noted that the 8/1/22 plan of care included the following goals: pain level will be per patient comfort and bowel status will be within normal limits for patient. There were no measurable details regarding the patient's pain comfort level or what would be within the normal limits for this patient regarding bowel status. It was unclear how these goals would be measured to determine the patient's progress towards discharge. The findings were reviewed with and acknowledged by Adm#2 (alternate administrator) and CM#1 during an interview on 9/8/22 at 12:45 p.m. MR#8: This patient was admitted to the agency on 3/16/22 with diagnoses of hypertensive heart disease, heart failure, and left-sided hemiplegia (paralysis/weakness).The 7/14/22 plan of care ordered weekly physical therapy services for this patient. During record review on 9/8/22, it was noted that the patient typically rated her pain at a 6 or 7 over this certification period. On 8/3/22 and 8/8/22 the patient rated her pain at 8. On 8/10/22, the patient rated her pain at a 9. There was no indication that the plan of care included parameters by which to notify the physician regarding excessive pain for this patient. During an interview on 9/8/22 at 1:00 p.m., CM#1 acknowledged that the plan of care should contain reportable pain parameters. MR#5: The start of care (SOC) was dated 5/3/22, with diagnoses that included hypertension (HTN), heart failure, and diabetes. During record review on 9/6/22, it was discovered that the skilled nursing goals on the POC were not measurable, for example, one goal stated, "Patient/caregiver will state understanding of measures to manage disease and identify s/s to report by 5/28/22." Another stated, "Patient/caregiver will verbalize/demonstrate understanding of symptom management, resource utilization and medication management to reduce unplanned hospital or emergency department visits by 5/28/22." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. During review it was also discovered that no oxygen precautions or bleeding/anticoagulant precautions were documented on the plan of care (POC) when the patient is on oxygen and Eliquis (anticoagulant). MR #6: The SOC was dated 1/21/22. The POC identified the diagnoses of sciatica, heart failure, asthma, and diabetes mellitus. During record review on 9/7/22, it was discovered that the skilled nursing goals on the POC were not measurable, for example, one goal stated, "Patient/caregiver will verbalize and demonstrate understanding of diabetic self-care needs by discharge." Another stated, "Patient/caregiver will verbalize signs and symptoms of hypo/hyperglycemia, measures to manage and when to report to registered nurse/physician by discharge." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. MR #7: The SOC was dated 7/27/22. The POC identified the diagnoses of embolism, chronic obstructive pulmonary disease (COPD), and pressure ulcers. During record review on 9/7/22, it was discovered that the skilled nursing goals on the POC were not measurable, for example, one goal stated, "Patient/caregiver will verbalize/demonstrate understanding of symptom management, resource utilization and medication management to reduce unplanned hospital or emergency department visits by 8/18/22." Another stated, "Increased activity tolerance by 8/18/22." There was no evidence of how these goals could be objectively measured to ascertain progress toward goals. During review it was also discovered that no bleeding/anticoagulant precautions were documented on the plan of care (POC) when the patient is on Eliquis (anticoagulant). During an interview on 9/8/22 at 11:45 a.m., the alternate administrator (Adm #2) and the clinical manager (CM #1) acknowledged the findings.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure services were provided in accordance with a physician's order in 1 of 8 records reviewed (MR #6) in which skilled nursing (SN) and physical therapy (PT) services provided care, from a total of 8 records reviewed, resulting in the potential for the patient to receive inappropriate or inadequate care. Findings include: MR #6: The SOC was dated 1/21/22. The POC identified the diagnoses of sciatica, heart failure, asthma, and diabetes mellitus. During record review on 9/7/22, it was discovered that the physician's order for the recertification period of 7/20/22-9/17/22 had SN and PT services ordered and was dated 8/19/22, 30 days after the recertification start date. The plan of care dated 8/26/22, for the same certification period was not signed by the physicain. The agency was providing services for 30 days without a physician order. During an interview on 9/8/22 at 11:45 a.m., the alternate administrator (Adm #2) and the clinical manager (CM #1) acknowledged the 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, record review and interview, it was determined that the Agency failed to ensure the Physician was promptly notified of 2 (MR's #1, 2) of 2 patients who experienced a significant change in condition and elevated vital signs, from a total of 8 sampled records reviewed, resulting in unadressed/untreated health concerns and the potential for unmet patient care needs. Findings include: MR #1: The patient's start of care (SOC) was 3/10/22 with diagnoses that included congestive Heart Failure and Hypertensive Heart Disease. During the record review on 9/6/22 at 12:22 p.m., it was noted that the referral for home care dated 3/4/22, ordered Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. The Initial "Adult Assessment" dated 3/10/22 completed by the Physical Therapist revealed the patient reported no pain (0/10) at the time of admission. During the review, it was noted that the patient complained of 6/10 on 3/15/22, 7/10 pain on 3/17/22, 8/10 pain on 3/22/22 and 7/10 pain 0n 3/29/22. Physical Therapy discharged the patient from the Agency's services on 4/2/22. There was no documented evidence at the time of this review, that the Physician had been notified of the patient's increased pain levels. Additionally, the Physical Therapy Assistant (PTA #1) documented the patient had weeping (drainage) and swelling to her bilateral lower extremities on 3/25/22 and 3/30/22. There was no documented evidence that the Physician had been notified promptly. These findings were reviewed with and acknowledged by the Assistant Administrator (Adm #2) and the clinical Manager (CM #1) during an interview on 9/7/22 at 1:51 p.m. MR #2: The patient's SOC was 8/10/22 with diagnoses that included Hypertension and diabetes Mellitus. During the record review on 9/7/22 at 3:18 p.m., it was noted that the referral for home care dated 8/4/22 ordered Skilled Nursing (SN), PT and OT services to be provided. The Plan of Care (POC) had specific reportable parameters in which to notify the Physician such as, Notify Physician of Pulse less than 60 and pain greater than 8/10. During the review, it was noted that the patient reported pain at a level of 10/10 on 8/23/22 and had a pulse of 56. The patient reported pain of 10/10 on 9/1/22 and during a home visit with the Registered Nurse (RN #1) on 9/7/22, the patient reported 10/10 pain to left ear and had a pulse of 55 to which RN #1 stated, "I see that you're brady (slow heart rate)." Upon further review of the clinical record, there was no documented evidence that the Physician had been promptly notified of the patient's complaints of pain or slow heart rate. These findings were reviewed with and acknowledged by Adm #2 and CM #1 during an interview on 9/8/22 at 9:21 a.m.

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 document any Quality Assessment Performance Improvement (QAPI) program activities for 2022 (G-660), to optimize patient outcomes, and to have at least one performance improvement project (PIP) this year. These deficient practices could affect all of the agency's patients admitted in 2022. The cumulative effect of these systemic problems resulted in the agency's inability to improve patient care, health outcomes, patient safety, and the agency's overall care performance, resulting in the potential for the agency to not provide quality health care. Findings include: 1. The agency failed to document any QAPI activities for 2022. (See G-660). 2. The agency failed to develop a PIP for 2022. (See G658).

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 it was determined the agency failed to initiate a performance improvement project (PIP) within their Quality Assessment Performance Improvement (QAPI) program, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: During review of the agency's QAPI program on 9/7/22, it was discovered that no QAPI data or activities were documented for 2022, and no PIP had been initiated for 2022. During an interview on 9/8/22 at 11:45 a.m., the alternate administrator (Adm #2) and the clinical manager (CM #1) acknowledged the findings.

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 review and interview, it was determined the Governing Body failed to ensure the agency had an active and functioning Quality Assessment and Performance Improvement (QAPI) program that fulfilled all the regulatory requirements of this section, that addressed priorities for improved quality of care and patient safety and was evaluated for effectiveness, resulting in the potential to adversely affect the quality of care to all patients receiving services. Findings include: **Agency policy: Quality Assessment and Performance Improvement (QAPI) committee, dated 2018. "The QAPI committee meets quarterly to advise the agency on professional issues, to participate in the evaluation of the agency's program and to assist the agency in maintaining liaison with other health care providers in the community...meetings are documenmted by dated minutes. During review of the agency's QAPI program on 9/7/22, it was discovered that no QAPI data, activities, meetings or QAPI related information was documented for 2022. During an interview on 9/7/22 at 4:00 p.m., the alternate administrator (Adm #2) stated, "I have not documented any QAPI activities for 2022."

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure effective infection prevention and control measures were utilized (G-682); failed to document any infection control meeting minutes for 2020, 2021 and 2022 (G-684); and failed to establish Vaccine protocol written policies and procedures that included (iii) implementation of additional precautions to mitigate the transmission and spread of Covid-19; (vii) a process for tracking/documenting information provided by staff who have requested/been granted an exemption from the Covid-19 requirements; (x) Contingency plans for staff who are not fully vaccinated for Covid-19, resulting in the potential for the development and spread of the Covid-19 virus to staff and all patients serviced by this Agency (G687). Infection prevention and control G-682. Meeting minutes G-684. Vaccinations G-687.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure its disciplines utilized Infection Control standards of practice during the provision of care and services for 2 (MR #2, 7) of 2 patients observed during home visits from a total of 8 sampled records reviewed, resulting in the potential for the development and spread of infection. Findings include: MR #2: The patient's start of care (SOC) was 8/10/22 with diagnoses that included Hypertension, Diabetes Mellitus, Fractured Vertebra and Fractured Toe. On 9/7/22 at 11:00 a.m., during a scheduled home visit with the Registered Nurse (RN #1), the following observations were made. During the provision of care, RN #1 placed her work back and disinfectant wipes directly on the patient's living room table. RN #1 did not place a barrier on the table prior to the placement of her equipment. RN #1 proceeded to assess the patient with gloves on. After assessing the patient's vital signs, RN #1 changed into a new pair of gloves to check the patient legs and feet for swelling and placed the dirty gloves on the patient's table. After this assessment, RN #1, while wearing the same gloves used to assess the patient's lower extremities, retrieved a disinfectant wipe to clean her care equipment (stethoscope and finger pulse oximeter) into her work bag. RN #1 then picked up her disinfectant wipes from the patient's table and placed the into her work bag. The pack of disinfectant wipes had not been wiped clean prior to placement into her (RN #1) work bag. RN #1 then removed her dirty gloves and again, placed them on the patient's table. RN #1 failed to utilize professional infection control standards of practice during the provision of care and services. These observations were discussed with and acknowledged by RN #1 during a post visit interview, who offered no response. These findings were also reviewed with and acknowledged by the Assistant Administrator (Adm #2) and the clinical Manager (CM #1) during an interview on 9/8/22 at 9:21 a.m. MR #7: The SOC was dated 7/27/22. The POC identified the diagnoses of embolism, chronic obstructive pulmonary disease (COPD), and pressure ulcers. During a scheduled home visit on 9/7/22 at 2:00 p.m. with registered nurse (RN #2), the following observations were made. RN #2 placed his supply bag directly on the patient's bed. RN #2 then pulled a cloth out of his bag and placed his supplies and equipment needed onto the cloth. RN #2 proceeded to obtain vitals on the patient then placed his stethoscope back into his supply bag without wiping it down. RN #2 initiated wound care treatment while neglecting to change gloves between the wound dressing removal and the placement of a new dressing. After completing wound care RN #2 placed his remaining equipment and supplies into his bag and then placed the cloth that he had placed on the bed for his supplies and equipment, back into his bag. During an interview on 9/8/22 at 11:45 a.m., the alternate administrator (Adm #2) and the clinical manager (CM #1) acknowledged the findings and said they will provide new inservices for the clinicians regarding infection control.

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 review and interview, the agency failed to maintain an agency-wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases as a part of the agency's Quality Assessment Performance Improvement (QAPI) program, resulting in the potential spread of infections between patient care staff and the agency's patients. Findings include: During review of the QAPI program on 9/7/22, it was discovered that there was no documentation of the infection control program being incorporated into the QAPI program. During review of the agency's policies on 9/8/22, a yearly infection control evaluation form (Blank) and a quarterly infection control aggregation and analysis form (Blank) were found. At the bottom of the blank evaluation form, there is a note to "Copy to organization's QAPI committee." During the QAPI review, there was no infection control program evaluation forms or quarterly infection control aggregation and analysis forms utilized. There was no infection control information documented in the QAPI program. During an interview on 9/8/22 at 11:45 a.m., the alternate administrator (Adm #2) and the clinical manager (CM #1) acknowledged the 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 record review and interview, the Agency failed to establish Vaccine protocol written policies and procedures that included (iii) implementation of additional precatutions to mitigate the transmission and spread of Covid-19; (vii) a process for tracking/documenting information provided by staff who have reqursted/been granted an exemption from the Covid-19 requirements; (x) Contingency plans for staff who are not fully vaccinated for Covid-19, resulting in the potential for the development and spread of the Covid-19 virus to staff and all patients serviced by this Agency. Findings include: On 9/6/22, upon review of the Agency's Vaccine policy, it was noted that the afore-mentioned requirements had not been included. There was no contingency plan put in to place for all staff who had not been vaccinated and/or who had been granted an exemption. There was no process put into place for tracking those individuals who had not been vaccinated. There was no process for the implementation of additional precautions for all staff who had not been vaccinated fully or in part. These findings were discussed with and acknowledged by the Assistant Administrator (Adm #2) during an interview on 9/7/22.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure the Registered Nurse conducted a thorough assessment and reassessment of the patient's health status for 1 (MR #2) of 1 patient observed during a home visit with a low heart rate and lower estremity swelling, from a total of 8 sampled records reviewed, resulting in the potential for unidentified, untreated health concerns and unmet patient care needs. Findings include: MR #2: The patient's start of care was 8/10/22 with diagnoses that included Hypertension, Diabetes Mellitus, Fracture of 3rd lumbar vertebra and Fractured Toe. During the clinical record review on 9/7/22 at 3:18 p.m., it was noted that the referral for home care dated 8/4/22 ordered Skilled Nursing, Occupational Therapy and Physical Therapy services to be provided. The Plan of Care (POC) had set parameters which included Notify Physician of pulse less than 60. During the record review, it was noted that on 8/23/22 the Registered Nurse (RN #1) documented a pulse of 56. There was no evidence to determine if the pulse was reassessed to deterine its accuracy. On 9/7/22 at 11:00 a.m., during a scheduled home visit with RN #1, the patient was noted to have swelling to her lower left leg to which RN #1 reported, "I see its still a bit swollen but not as much as before." During the record review, there were no documented measurements of edema to the patient's lower extremities. RN #1 did not measure the patient's edema during the home visit. Additionally, RN #1 used an automated pulse oximetry finger device to obtain the patient's oxygen levels and pulse/ The patient's pulse reading was 55, which was outside of/below the established parameters. RN #1 did not manually reasssess the patient's pulse/heart rate to determine its accuracy. These findings were reviewed with RN #1 upon completion of the onsite visit. RN #1 acknowledged the findings yet offered no response. RN #1 failed to conduct accurate patient care assessments to identify the needs of the patient. The above findings were also reviewed with and acknowledged by the Assistant Administrator (Adm #2) and the Clinical Manager (CM #1) during an interview on 9/8/22 at 9:21 a.m.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure physical therapy (PT) services were provided as ordered by the physician in the plan of care (POC) for 1 of 6 (MR# 6) records reviewed with PT services ordered, from a total sample of 8 records, resulting in the potential for physical decline and negative patient outcomes. Findings include: MR #6: The start of care (SOC) was dated 1/21/22. The POC identified the diagnoses of sciatica, heart failure, asthma, and diabetes mellitus. During record review on 9/7/22, it was discovered that the recertification OASIS dated 7/18/22, documented the need for PT services under M2200 (12 visits).The POC dated 8/26/22, had an evaluation and treatment for PT ordered. No PT visits were made as of 9/8/22, 52 days after the recertification date. During an interview on 9/8/22 at 11:45 a.m., the alternate administrator (Adm #2) and the clinical manager (CM #1) acknowledged the findings.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the home health agency failed to have an active Governing Body that met at least annually, and assumed full legal authority and responsibility for the agency's overall management and operations, all services provided, the fiscal operations, review of the agency's budget and operations plans and it's quality assessment and performance improvement program, since 2019, resulting in the potential to adversely affect the quality of care to all patients receiving services. **Agency Policy: Governing Body, dated 2018. "The governing body meets at least annually to review the operations of the agency and documents all meetings by minutes. Meeting minutes will be retained for 5 years." During Governing Body review on 9/7/22, it was discovered that no Governing Body meeting minutes were found for 2020, 2021 or 2022. The alternate administrator (Adm #2) was asked for governing body meeting minutes for review, Adm #2 stated, "I have not documented any governing body meeting minutes for 2020, 2021, or 2022."

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on interview, the agency failed to ensure to have a written agreement with 10 of 10 (OT#1, SW#1, PT#2, PTA#1, RN#1, PT#3, RN#3, PTA#4, PT#5, and LPN#1)) independent contractors furnishing services under arrangement to agency patients, resulting in a lack of overall responsibility by the agency for the services provided under arrangement. Findings include: During the entrance conference interview with the alternate administrator (Adm#2) on 9/6/22 at 10:37 a.m., Adm#2 explained that the agency employs one registered nurse (RN#2) and one physical therapist (PT#1) as W2 employees. Adm#2 explained that all other field staff are 1099 agency employees. Adm#2 states that they are not contracted employees...they are 1099s...they are agency employees...and the agency does not have contracts with the 1099 employees. Adm#2 was unable to provide contracts for review for the following 1099 employees that were providing patient care for the agency: OT#1 provides occupational therapy services and was hired on 5/22/18. SW#1 provides social work services and was hired on 9/11/17. PT#2 provides physical therapy services and was hired on 5/22/18. PTA#1 provides physical therapy assistant services and was hired on 1/20/14. RN#1 provides registered nursing services and was hired on 7/1/21. PT#3 provides physical therapy services and was hired on 9/15/21. RN#3 provides registered nursing services and was hired on 10/14/19. PTA#4 provides physical therapy assistant services and was hired on 11/20/20. PT#5 provides physical therapy services and was hired on 5/1/20. LPN#1 provides nursing services and was hired on 9/8/22. The agency failed to follow its own policy titled, Contractors Services (2018) which states, the Agency will contract with providers of supplemental patient care services. Written agreements/contracts will clearly delineate the scope of services/responsibilities and billing expectations.

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on interview, the agency failed to ensure that at least one qualifying service was provided directly by agency employees, resulting in the agency contracting for all patient services. This deficient practice has the potential to negatively affect all 272 patients admitted to the agency in the past year. Findings include: During the entrance conference interview with the alternate administrator (Adm#2) on 9/6/22 at 10:37 a.m., Adm#2 explained that the agency employs one registered nurse (RN#2) and one physical therapist (PT#1) as W2 employees. Adm#2 explained that all other field staff are 1099 agency employees. Adm#2 states that they are not contracted employees...they are 1099s...they are agency employees...and the agency does not have contracts with the 1099 employees. All services currently provided by the agency are a mixture of agency staff and 1099 (contract) staff. There was no documented evidence that the agency provides at least one qualifying service directly by agency employees. The agency failed to follow its own policy titled, Contractors Services (2018) which states, Agency will make available part-time or intermittent skilled nursing services and at least one other therapeutic service (PT, OT, SLP, MSW or HHA) on a visiting basis to patient's home. The Agency will furnish one of the qualifying services directly through Agency staff.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record contained all clinical notes for 1 of 8 (MR#4) records reviewed, resulting in a lack of information for the physician and all agency staff caring for this patient. Findings include: MR#4: This patient was admitted to the agency on 8/1/22 with diagnoses of pancreatic cancer and heart failure. The 8/1/22 plan of care ordered twice weekly skilled nursing visits for this patient. During record review on 9/6/22, it was noted that the nursing visit note on 8/26/22 was blank of information. After 8/26/22, there were no documented nursing visit notes for the week of 8/28/22 through 9/3/22. During an interview on 9/6/22 at 11:30 a.m., the clinical manager (CM#1) stated that staff has 48 hours to complete their visit notes. It was unclear what had happened with this patient. The agency failed to ensure the clinical record contained all clinical notes.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Transfer/Discharge summaries were completed, detailed, and provided the patient's current health status at the time of Transfer/Discharge, included information on progress toward goals, and forwarded to the receiving facility within 2 days, and forwarded to the Physician within 5 days of discharge in 4 (MR's# 1, 2, 3 and 5) of 5 records reviewed in which the patient was Discharged/Transferred to a hospital or from the Agency's services, from a total of 8 sampled records reviewed, resulting in the potential for unidentified continuing health care concerns and unmet care needs. Findings include: MR #1: The patient's start of care (SOC) was 3/10/22 with diagnoses that included Congestive Heart Failure, Hypertensive Heart Disease and abnormality of gait and mobility. During the clinical record review on 9/6/22 at 12:22 p.m., it was noted that the referral for home care dated 3/4/22 ordered Occupational Therapy (OT) to provide ADL training and Physical Therapy (PT) for balance training, gait training and functional mobilities. The patient was discharged from OT services on 3/24/22. The OT Discharge Summary dated 3/24/22 was incomplete and failed to include a summary of care that detailed the course of care provided with responses that included the patient's status at the time of discharge. Additionally, there was no documented evidence that the Physician had been notified of or sent a copy of a completed discharge summary within 5 days of the patient's discharge. The patient was discharged from PT services on 4/2/22. Physical Therapy Discharge Summary dated 4/2/22 was void of a summary of care that detailed the course of care provided and the patient's status at the time of discharge. The section titled "Discharge Instructions" was left blank. The section titled "Summary Sent to:" listed the referring Physician, however, there was no completed summary of care to be sent to the Physician to aid in any potential continuing health care needs. Additionally, during the review, it was noted that the patient was transferred to the hospital on 3/17/22 due to uncontrolled nose bleeds. At the time of this review, no Transfer Summary had been completed. These findings were reviewed with and acknowledged by the Assistant Administrator (Adm #2) and the Clinical Manager (CM #1) during an interview on 9/7/22 at 1:51 p.m. MR #2: The patient's SOC was 8/10/22 with diagnoses that included Hypertension, Diabetes Mellitus, Fracture 3rd Vertebra and Fractured Toe. During the clinical record review on 9/7/22 at 3:18 p.m., it was noted that the patient was transferred to the hospital on 9/2/22. The "Oasis Transfer Non-Visit" Assessment was void of the required Summary of Care. The section of the assessment titled "Transfer Summary" was left blank. Additionally, the section that addressed if the summary was sent to the Physician was left unchecked. There was no documented evidence that a Transfer Summary had been completed and forwarded to the Physician and the receiving facility within the specified timeframes, in accordance with this requirement. These findings were reviewed with and acknowledged by Adm #2 and CM #1 during an interview on 9/8/22 at 9:21 a.m. MR#5: The start of care (SOC) was dated 5/3/22, with diagnoses that included hypertension (HTN), heart failure, and diabetes. During record review on 9/6/22, it was discovered that the discharge summary failed to document the patient's discharge condition regarding all listed diagnoses, outcomes towards meeting goals, frequency of services provided, and medications at discharge. There was no documentation in the record that the discharge summary was sent to the physician. During an interview on 9/8/22 at 11:45 a.m., the alternate administrator (Adm #2) and the clinical manager (CM #1) acknowledged the findings. MR#3: This patient was admitted to the agency on 8/3/22 with diagnoses of aftercare following a craniotomy for a brain tumor. The patient received weekly physical therapy (PT) services and was discharged from the agency by PT on 8/19/22. During record review on 9/7/22, there was no evidence that a discharge summary of care had been sent to the physician within 5 business days of discharge from the agency. The finding was reviewed with and acknowledged by the alternate administrator (Adm#1) and the clinical manager (CM#1) during an interview on 9/8/22 at 12:30 p.m.