Every finding on record at Primary Choice Home Care of Michigan, LLC

The following condition level deficiencies were identified during an Emergency Preparedness Survey conducted by the Michigan Department of Licensing and Regulatory Affairs on 2/24/21 through 2/26/21 at: Primary Choice Home Care of Michigan 32985 Hamilton Court, Suite 216 Farmington Hills, MI 48334 This agency had no additional branch locations The following condition level deficiency was identified: 42 CFR §484.102 Emergency Preparedness.

Establishment of the Emergency Program (EP) CFR(s): 484.102 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] 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: *[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 document review and interview, the agency failed to develop an Emergency Preparedness Program that met the Federal, State and local requirements of this section (See E0004); failed to complete an Emergency Preparedness Plan that was based on a facility and community based risk assessment (See E0006); failed to develop and maintain an emergency preparedness communication plan that included contact information for all current staff, patient's physicians and volunteers, as appropriate, which had the potential to negatively affect the health and safety of the 14 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency (See E0030); failed to provide initial training to all staff, of the agency's emergency preparedness program, the training of the policies and procedures, provide annual training and maintain documentation of all training (See E0037). The cumulative effects of these deficient practices resulted in no directions for agency actions in the event of an actual emergency or disaster. This deficient practice could negatively affect the health and safety of all 76 agency patients serviced in the past 12 months in the event of a facility or community emergency or disaster. The cumulative effect of these systemic problems could potentially have a negative effect on all patients cared for by the home health agency in the event staff is not properly prepared for an emergency for the Condition of Participation of 42 CFR §485.102, Emergency Preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop 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: (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 all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [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. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. This STANDARD is not met as evidenced by: Based on document review and interview, the Agency failed to develop and maintain an emergency preparedness program that included the required elements, that must be reviewed, and updated at least annually, resulting in the potential to affect the Agency's ability to provide safe patient care in the event of an actual emergency. Findings Include: On 2/26/21, review of the Agency's Emergency Preparedness Plan (EP) failed to provide any evidence that a review or updates had been documented. This deficient practice was confirmed during an interview with Adm#1 on 2/26/21 at 9:15 am and confirmed the findings stating, "I did a tabletop exercise in September of 2019. Nothing else has been done since the previous recertification survey in 2018."

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(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 LTC facilities at §483.73(a)(1):] 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)(1):] 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. * [For Hospices at §418.113(a)(2):] 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. This STANDARD is not met as evidenced by: Based on interview and record review, the Agency failed to conduct a facility-based and community-based risk assessment resulting in the potential for failure to identify hazards associated with the facility and less than optimal outcomes during an emergency event. This could potentially affect staff, and all patients serviced by this agency in the event of an emergency. Findings include: On 2/26/21, review of the Agency's Emergency Preparedness Plan (EP) failed to provide any evidence that a review or updates had been documented. This deficient practice was confirmed during an interview with Adm#1 on 2/26/21 at 9:15 am and confirmed the findings stating, "I did a tabletop exercise in September of 2019. Nothing else has been done since the previous recertification survey in 2018."

Names and Contact Information CFR(s): 484.102(c)(1) [(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).] The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, it was determined that the facility failed to develop and maintain an emergency preparedness communication plan that included contact information for all current staff, patient's physicians and volunteers, as appropriate, which had the potential to negatively affect the health and safety of the 22 patients currently serviced by this agency, resulting in the lack of effective communication in the event of an actual emergency. Findings include: On 2/26/21, review of the Agency's Emergency Preparedness Plan (EP) failed to provide any evidence that a review or updates had been documented. This deficient practice was confirmed during an interview with Adm#1 on 2/26/21 at 9:15 am and confirmed the findings stating, "I did a tabletop exercise in September of 2019. Nothing else has been done since the previous recertification survey in 2018."

EP Training Program CFR(s): 484.102(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 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 on document review and interview, it was determined the Agency failed to provide initial training in emergency preparedness policies and procedures to all new and existing staff, including contract employees and volunteers, and failed to maintain documentation of training's, resulting in the potential for inappropriate, unprepared responses to emergencies and interruption in the provision of needed patient care and services. Findings include: On 2/26/21, review of the Agency's Emergency Preparedness Plan (EP) failed to provide any evidence that a review or updates had been documented. This deficient practice was confirmed during an interview with Adm#1 on 2/26/21 at 9:15 am and confirmed the findings stating, "I did a tabletop exercise in September of 2019. Nothing else has been done since the previous recertification survey in 2018."

A Medicare recertification survey was conducted by the Michigan Department of Licensing and Regulatory Affairs on February 24, 2021 through February 26, 2021 at: Primary Choice Home Care of Michigan 32985 Hamilton Court, Suite 216 Farmington Hills, MI 48334 Clinical records reviewed for this survey included 3 records with home visits, 3 records without home visits and 2 discharged records for a total of 7 records reviewed. The agency does not maintain any branch sites. The following Condition Level deficiencies were identified: 42 CFR§484.102: Emergency Preparedness. 42 CFR§484.105: Organization and Administration of Services. 42 CFR§484.110: Clinical Records. 42 CFR §484.65: Quality Assessment and Performance Improvement (QAPI). 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).

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to inform the patient/caregiver before care was initiated of the extent to which payment for home health agency services may be expected from Medicare or other insurance sources and the extent to which payment may be required from the patient in 2 of 7 records reviewed (MR#s 1 and 3), resulting in the potential for undisclosed charges. Findings included: MR#1: The Start of Care (SOC) was dated 8/29/20. The Plan of Care (POC) identified diagnoses of Diabetes Type 2 and Peripheral Vascular Disease. Upon review of the record, it was noted that the Admission Consent failed to include the amount the patient would be responsible to pay for services from the agency. The area under "Insurance pays and You Pay" is blank in the area to document the possible Co-pay for which the patient may be responsible for. The home health agency failed to advise the patient, in writing, of the possible charges they may be responsible for paying before care was initiated. MR#3: The Start of Care (SOC) was dated 2/9/21. The Plan of Care (POC) identified diagnoses of Parkinson's and Pressure Ulcer Left Foot Stage 2. Upon review of the record, it was noted that the Admission Consent failed to include the amount the patient would be responsible to pay for services from the agency. The area under "Insurance pays and You Pay" is blank in the area to document the possible Co-pay for which the patient may be responsible for. The home health agency failed to advise the patient, in writing, of the possible charges they may be responsible for paying before care was initiated. The Adm#1 was questioned on 2/26/21 at 11:35 am and confirmed the findings stating, "Yes, those were not filled out correctly."

Patient refuses services CFR(s): 484.50(d)(4) The patient refuses services, or elects to be transferred or discharged; This ELEMENT is not met as evidenced by: Based on record review, and interview, the agency failed to inform and educate the patient of potential adverse outcomes from refusing services in 1 (MR# 6) of 1 record reviewed with multiple missed visits due to patient refusal from a total sample of 7 records, resulting in the potential for unmet care needs. Findings included: MR#6: The Start of Care (SOC) was dated 9/18/2020. The Plan of Care (POC) identified diagnoses of multiple sclerosis, diabetes with polyneuropathy, and congestive heart failure. The POC ordered Physical Therapy only services at a frequency of 1W1, 2W2, 1W6 (once a week for one week, twice weekly for two weeks, and once a week for six weeks). On 2/25/2021, record review noted 4 of 5 visits were made from 9/18/2020 through 10/2/2020 with no complaints noted by either staff or patient. The medical record then documented that 7 of 7 scheduled visits (10/7/20-11/13/20) were missed due to either patient refusal or no answer at the patient's door. The patient was discharged from the Agency on 11/13/2020 for non-compliance. No documentation was found within the medical record documenting efforts made to ascertain the reason for non-compliance, informing/educating the patient of the risks from refusing services, or the physician's response concerning the patient's sudden non-compliance. During an interview with the agency's Administrator (Adm#1) on 2/26/21 at 9:45 AM, Adm#1 acknowledged the above findings and stated, "I hope the patient's ok; we need to make a better effort to find out what's going on with the patient when something like this happens. I will have a talk with the therapist." The agency failed to ensure appropriate measures were taken to inform the patient.

Advise the patient of discharge for cause CFR(s): 484.50(d)(5)(i) (i) Advise the patient, representative (if any), the physician(s) or allowed practitioner(s), issuing orders for the home health plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) that a discharge for cause is being considered; This ELEMENT is not met as evidenced by: Based on record review, and interview, the agency failed to inform the patient and the physician that a discharge for cause from the agency was being considered in 1 (MR# 6) of 1 record reviewed for discharge with cause from a total sample of 7 records, resulting in the potential for unmet care needs. Findings included: MR#6: The Start of Care (SOC) was dated 9/18/2020. The Plan of Care (POC) identified diagnoses of multiple sclerosis, diabetes with polyneuropathy, and congestive heart failure. The POC ordered Physical Therapy (PT) only services at a frequency of 1W1, 2W2, 1W6 (once a week for one week, twice weekly for two weeks, and once a week for six weeks). On 2/25/2021, record review noted 4 of 5 visits were made from 9/18/2020 through 10/2/2020 with no complaints noted by either staff or patient. The medical record then documented that 7 of 7 scheduled visits (10/7/20-11/13/20) were missed due to either patient refusal or no answer at the patient's door. The patient was discharged from the Agency on 11/13/2020 for non-compliance. No documentation was found within the medical record documenting notification to the patient or the physician of PT's intention to discharge. During an interview with the agency's Administrator (Adm#1) on 2/26/21 at 9:50 AM, Adm#1 acknowledged the above findings and stated, "I can't find anything from PT documenting his intent to discharge to the patient or the physician."

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 document review and interview, the agency failed to ensure a registered nurse performed a review of the patient's medication list in which therapy only services were ordered in 2 of 2 records (MR #4, and 6) reviewed, from a total sample of 7 records, resulting in the potential for harmful medication effects for all 76 patients serviced by this agency in the last 12 months. Findings include: **Agency Policy: "Medication Monitoring/Orders/Teaching/Documentation" (Rev. 05/04) pg. 315 stated, "For patients who receive therapy only, the Physical or Speech Therapist will record all the medications the patient is currently taking. The medications are reviewed by a nurse Clinical Supervisor or an RN staff member. The physician is notified of any interactions or contraindications identified, ..." MR#4: This patient was admitted to the agency on 11/13/2020 with diagnoses of Chronic Obstructive Pulmonary Disease (COPD), left hip osteoarthritis, and chronic left hip pain. The 11/13/20, the plan of care (POC) ordered physical therapy (PT) to evaluate and treat the patient. During review of the clinical record on 2/25/21, it was documented that the patient's medication review at the start of care (SOC) was performed by PT#1. No evidence of a subsequent review by a registered nurse (RN) was found in the medical record. During an interview on 2/25/21 at 2:53 PM., the Clinical Director (CD#1) confirmed the above finding during a joint review of the clinical record with the surveyor. MR#6: The start of care (SOC) was 9/18/2020. The POC identified diagnoses of Multiple Sclerosis, Diabetes-Type 2, and Congestive Heart Failure. During review of the clinical record on 2/25/21, it was documented that the patient's medication review at the SOC was performed by PT#1. No evidence of a subsequent review by a registered nurse was found in the medical record. During an interview on 2/26/21 at 9:50 AM., CD#1 confirmed the above finding during a joint review of the clinical record with the surveyor. CD#1 stated, "I will make sure nursing reviews the medication list for all cases going forward." The agency failed to provide evidence an RN had reviewed the patient's medication list at the SOC as stipulated by agency policy.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on document review and interview, it was determined that the agency failed to ensure the Plan of Care included objectively measurable and individualized goals in 3 of 5 records reviewed (MR#s 2, 5, and 7) with skilled nursing ordered out of a total of 7 records reviewed, resulting in a potential for failure to measure progress toward achievement of desired outcomes. Findings include: **Agency Policy: Content and Format of the Patient Record (Undated) states, "Procedure: e) Physician's orders/plan of care 2) Measurable goals. 3) Safety measures required to protect the patient from injury. MR#2: The Start of Care (SOC) was dated 6/13/20. The Plan of Care (POC) identified diagnoses of Stage 4 Pressure Ulcer Left Buttock and Paraplegia. During record review on 2/25/21, it was noted that the goals on the POC were not measurable, for example the Skilled Nursing goals stated, "Patient will have no new skin breakdown by end of this cert period. Patient will be safe with transfers and without evidence of falls this cert period. Patient will have no evidence of possible complications from HIV within cert period." There was no evidence of how these goals could be quantitatively measured. The Adm#1 was questioned on 2/26/21 at 11:45 am and confirmed the findings stating, "The goals are not measurable." MR#5: The Start of Care (SOC) was dated 1/29/2021. The Plan of Care (POC) identified diagnoses of venous insufficiency, diabetes-type 2, and chronic kidney disease. During record review on 2/25/21, it was noted that the Skilled Nursing (SN) goals on the POC were not measurable (8 of 8), for example: "Patient will verbalize understanding and demonstrate importance of self-care needs and identify self-care deficit to improve quality of life. Patient/caregiver will demonstrate infection control techniques by second week." There was no evidence of how these goals could be quantitatively measured. MR#7: The patient's SOC was 1/7/2021 with identified diagnoses of pressure ulcer-left buttock-stage 2, Parkinson's disease, and morbid obesity. During record review on 2/26/21, the POC ordered SN twice a week for three weeks followed by once weekly times six weeks. SN interventions noted on the POC were as follows: wound care treatment, wound instruction to prevent further breakdown, medication teaching, safety measures, ... ways to prevent complications. The POC however failed to include any SN goals to address and track progress made concerning the above interventions. The Administrator (Adm#1) confirmed the findings during an interview on 2/26/21 at 10:55 AM, and stated, "I forgot to include nursing goals on this care plan."

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 contained patient specific orders, individualized to the patient's identified needs, and covered all pertinent interventions with reportable parameters for 2 of 7 records reviewed (MR#'s 2,, and 6), resulting in patients not receiving care specific to their needs and the potential for poor patient outcomes. Findings included: **Agency Policy: "Physician Role in Plan of Care and Management of Patients," (Undated). The policy states, "3. The plan of care includes: K. Specific procedures/treatments to be performed, including amount, frequency, and duration. MR#2: The Start of Care (SOC) was dated 6/13/20. The Plan of Care (POC) identified diagnoses of Stage 4 Pressure Ulcer Left Buttock and Paraplegia. The POC's dated 12/10/20 and 2/8/21 contained the Skilled Nursing (SN) wound care order of "SN to perform wound care per protocol as ordered by wound care specialist every visit." The agency failed to document the wound care order from the wound care specialist in the POC. The Adm#1 was questioned on 2/26/21 at 11:45 am and confirmed the findings stating, "The wound care order is not documented in the Plan of Care." MR#6: The start of care (SOC) was 9/18/2020. The plan of care (POC) identified diagnoses of Multiple Sclerosis, Diabetes-Type 2, and Congestive Heart Failure. During record review on 2/25/2021, it was noted the POC failed to incorporate any treatments, interventions with reportable parameters for any of the above diagnoses throughout the entire certification period. Examples of expected safety parameters/interventions to be found in which to notify the physician in the event the following fell outside of the patient's acceptable range: weight or circumference measurement increases concerning the patient's Congestive Heart Failure, and blood sugar levels regarding the patient's Diabetes. During an interview with the Administrator (Adm#1) on 2/26/21 at 9:43 AM, the findings were reviewed and acknowledged. Adm#1 stated, "I agree, the care plan should've had these types of parameters included to monitor the patient."

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on document review and interview, it was determined that the agency failed to ensure the revised Plan of Care reflected the current information from the updated comprehensive assessment in 1 of 1 recertified record reviewed (MR#s 2) out of a total of 7 records reviewed, resulting in the physician not having a clear and concise clinical picture of the patient's health status and progress towards goals. These deficient practices could negatively affect the health and well-being of this one patient. Findings include: MR#2: The Start of Care (SOC) was dated 6/13/20. The Plan of Care (POC) identified diagnoses of Stage 4 Pressure Ulcer Left Buttock and Paraplegia. During record review on 2/25/21, it was noted that the POC dated 12/10/20 contained a goal of "UTI will be resolved in 2 weeks with the current prophylactic medication" and a new medication starting on 12/8/20 of Amoxicillin 500mg 1 cap x 14 days oral every 12 hours. The POC dated 2/8/21 contained the same goal without the medication. The agency failed to update the POC from 12/8/20 to 2/8/21. The Adm#1 was questioned on 2/26/21 at 11:45 am and confirmed the findings stating, "Yes, the Plan of Care was not updated to show the resolution of the UTI."

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 policy review and interview, it was determined the home health agency failed to develop a Quality Assessment and Performance Improvement (QAPI) policy and program, (refer to G-642); the agency failed to collect and monitor data for the Quality Assessment and Performance Improvement (QAPI) program, (refer to G-644); failed to initiate any performance improvement activities within their Quality Assessment Performance Improvement (QAPI) program that focused on high risk, high volume or problem prone areas, (refer to G-648); and 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 (refer to G-660). The cumulative effect of these systemic problems resulted in the agency's inability to ensure the provision of quality health care for all the patients the Home Health Agency serves for the condition of participation of 42 CFR§484.65 Quality Assessment and Performance Improvement (QAPI).

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 review and interview, it was determined the agency failed to develop, implement, and maintain a quality assessment and performance improvement program which had the potential to negatively affect all 76 patients that were admitted during the past 12 months, resulting in a potential for poor patient outcomes due to the provision of substandard care. Findings include: The Adm#1 was questioned on 2/26/21 at 9:45 am and confirmed the findings stating, "I do not have anything for QAPI."

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 interview, the agency failed to monitor data for the Quality Performance Improvement (QAPI) program, to ensure the effectiveness and safety of services and quality of care to the patients and to identify opportunities for improvement, and there was no documented evidence the governing body approved the QAPI frequency and data collection process. Findings included: The Adm#1 was questioned on 2/26/21 at 9:45 am and confirmed the findings stating, "I do not have anything for QAPI."

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on interview, it was determined the Home Health Agency (HHA) failed to develop a QAPI (Quality Assessment Performance Improvement) program that focused on high risk, high volume or problem-prone areas of the agency, to monitor the agency's improvement in these areas resulting in the agency's inability to improve in patient care, health outcomes, patient safety, quality of care and the agency's performance. Findings include: The Adm#1 was questioned on 2/26/21 at 9:45 am and confirmed the findings stating, "I do not have anything for QAPI."

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 interview, it was determined the Governing Body failed to ensure the Agency had an active and functioning Quality Assessment and Performance Improvement program 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 22 patients currently receiving services and all 76 patients admitted over the past year. Findings include: The Adm#1 was questioned on 2/26/21 at 9:45 am and confirmed the findings stating, "I do not have anything for QAPI."

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the Physical Therapist and the Occupational Therapist developed plans of care in a timely manner for 2 of 6 (MR# 1 and 3) records reviewed in which more than one discipline was ordered to provide care, resulting in a potential decline in physical functioning for these patients. Findings include: MR#1: The Start of Care (SOC) was dated 8/29/20. The Plan of Care (POC) identified diagnoses of Diabetes Type 2 and Peripheral Vascular Disease. The POC dated 8/29/20 ordered Physical Therapy (PT) and Occupational Therapy (OT) to evaluate and treat the patient. The PT completed their evaluation on 9/2/20, 4 days after the SOC. The OT completed their evaluation on 9/7/20, 9 days after the SOC. Adm#1 stated during the entrance interview on 2/24/21 at 12:15 pm, "The agency has 2 days after the start of care to get other disciplines out to see the patient and complete their evaluations." There is no documented evidence the patient or caregiver requested a delay in evaluations. MR#3: The Start of Care (SOC) was dated 2/9/21. The Plan of Care (POC) identified diagnoses of Parkinson's and Pressure Ulcer Left Foot Stage 2. The POC dated 2/9/21 ordered PT and OT to evaluate and treat the patient. The PT completed their evaluation on 2/25/21, 16 days after the SOC. The OT has yet to complete their evaluation. Adm#1 stated during the entrance interview on 2/24/21 at 12:15 pm, "The agency has 2 days after the start of care to get other disciplines out to see the patient and complete their evaluations." There is no documented evidence the patient or caregiver requested a delay in evaluations. The Adm#1 was questioned on 2/26/21 at 11:45 am and confirmed the findings stating, "Yes, the evaluations were late."

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on record review and interview, it was determined the registered nurse failed to supervise the services provided by the Licensed Practical Nurse (LPN) every 30 days for 1 of 1 record reviewed with LPN services (MR# 2) out of a total of 7 record review with nursing services, resulting in failure of the LPN to provide services as ordered by the physician and unmet patient care needs. Findings include: **Agency Policy: "Supervision and Assignment of LPN's, Social Work, and Therapy Assistants." (Undated). The policy states, "Procedure: 5. Supervised home visits will be made by the professional according to client's needs, but at least once every month. It is preferred that the supervisory visit be conducted with the LPN or assistant present." MR#2: The Start of Care (SOC) was dated 6/13/20. The Plan of Care (POC) identified diagnoses of Stage 4 Pressure Ulcer Left Buttock and Paraplegia. The POC dated 12/10/20 contained a Skilled Nursing (SN) frequency of 1w1 (1 visit per week for 1 week), 2w8. The POC dated 2/8/21 contained a SN frequency of 1w1, 2w8. The Comprehensive assessment was completed by a Registered Nurse (RN) on 12/10/20 and recertified on 2/3/21. The Licensed Practical Nurse (LPN) completed all the visits dated 12/11/20 through 2/1/20, 8 weeks total. During record review on 2/5/21, there was no documentation that the LPN was supervised by a RN at least monthly per policy. The Adm#1 was questioned on 2/26/21 at 11:45 am and confirmed the findings stating, "There was no LPN supervision completed for that patient."

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on record review and interview, it was determined the agency failed to ensure that 2 of 2 Home Health Aide employed by the Agency, received the required 12 hours of annual in-service training, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: On 2/26/21, a review of the HHa#1 and HHa#2 personnel files for the 2020 and 2021 calendar year revealed the following. HHa #1's hire date was 4/3/06 and it noted documented in-service training forms dated from 1/8/20 to 9/26/20, that totaled 11 hours. HHa #1's hire date was 4/5/19 and it noted documented in-service training forms dated from 2/9/20 to 8/20/20, that totaled 4 hours. The Adm#1 was questioned on 2/26/21 at 12:05 pm and confirmed the findings stating, "They have not completed their required 12 hours of annual in-service training."

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on document review, and interview, the agency failed to ensure the Administrator performed required day-to-day operations (See G 948); failed to ensure the Clinical Manager consistently monitored and assessed patient needs to ensure services were provided as ordered (See G 966) and failed to ensure the plans of care were updated according to the patients' needs (See G 968). This deficient practice could negatively affect the health and safety of all 76 agency patients serviced in the past 12 months, resulting in the potential for poor patient outcomes. 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 of 42 CFR§484.105 Organization and Administration of Services.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on document review, and interview, it was determined the Administrator failed to be responsible for all day-to-day operations of the Home Health Agency, resulting in a lack of supervision of the clinical staff and daily operations. Findings include: During review of extended survey tasks on 2/25/2021, it was noted the Administrator failed to review and update the required program evaluations concerning the following since the last recertification survey dated 8/2/2018: Annual agency evaluation and Annual Report, Performance Improvement Projects, and Emergency Preparedness. During an interview with the Administrator (Adm#1) on 2/26/21 at 10:55 AM, the findings were reviewed and acknowledged. Adm#1 stated, "I haven't been keeping up with these since the last survey, I wasn't ready."

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on documents reviewed and interview, it was determined the home health agency failed to ensure services were provided as ordered on the plan of care and the patients' needs were continually assessed for 1 of 7 records reviewed (MR #4), resulting in the potential of unmet care needs for all 76 patients serviced within the last 12 months. Findings include: **Agency Policy: Client Care Records (Undated) states, "Basic Record Requirements: All entries in the health record must be: 2. Recorded within 24 hours of the provision of service." MR#4: This patient was admitted to the agency on 11/13/2020 with diagnoses of Chronic Obstructive Pulmonary Disease (COPD), left hip osteoarthritis, and chronic left hip pain. The 11/13/20, the plan of care ordered physical therapy (PT) only services to be provided twice a week for six weeks (2w6). The record was reviewed on 2/25/21 and it noted that 7 of 8 visits were made from 11/13/20 through 12/7/20. The patient was recertified for PT only on 1/11/2021 at a frequency of 2w6. There were no additional documented PT visits for the past 80 days (12/7/20 through 2/25/21). There was no documentation to indicate the patient had declined PT visits and no evidence of physician communication was found with the clinical record. There were no findings that indicated the Clinical Director (CD#1) who also functions as the agency's Administrator, had reviewed, or intervened on the patient's behalf to ensure services were appropriately furnished as ordered. These findings were reviewed with and confirmed by the Administrator (Adm#1) during an interview on 2/25/21 at 2:47 p.m. Adm#1 stated, "We've tried to get him to turn in his documentation, but he just won't do it." The Clinical Director failed to provide clinical oversight and enforce the Agency's policy of submitting documentation within 24 hours of services being provided for the past 80 days.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the Clinical Director failed to ensure the plan of care was updated as needed for 1 of 7 (MR #6) records reviewed, resulting in a potential decline in physical functioning, and verification of the patient's well-being. Findings include: MR#6: The Start of Care (SOC) was dated 9/18/2020. The Plan of Care (POC) identified diagnoses of multiple sclerosis, diabetes with polyneuropathy, and congestive heart failure. The POC ordered Physical Therapy only services at a frequency of 1W1, 2W2, 1W6 (once a week for one week, twice weekly for two weeks, and once a week for six weeks). On 2/25/2021, record review noted 4 of 5 visits were made from 9/18/2020 through 10/2/2020 with no complaints noted by either staff or patient. The medical record then documented that 7 of 7 scheduled visits (10/7/20-11/13/20) were missed due to either patient refusal or no answer at the patient's door. The patient was discharged from the Agency on 11/13/2020 for non-compliance. No evidence of oversight was found from the Clinical Director concerning changes/updates on the POC to address and intervene on the patient's behalf to optimize patient care. Interventions to ascertain the reason for non-compliance or educational goals to inform the patient of the risk from refusing services were not found on the POC. During an interview with the agency's Administrator (Adm#1) on 2/26/21 at 9:45 AM, Adm#1 acknowledged the above findings and stated, "I hope the patient's ok; we need to make a better effort to find out what's going on with the patient when something like this happens. I will have a talk with the therapist." The Clinical Director failed to ensure the patient's POC was updated to address the abrupt change noted in the patient's participation concerning the treatment plan.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on document review and interview, the agency failed to ensure the clinical record was complete and included all comprehensive assessments, clinical notes, plans of care and physician orders for 3 records (MR# 2, 3, and 4) from a total of 7 sampled records (G1012), and failed to ensure a discharge summary was sent to the physician within 5 business days for 2 of 2 discharge records (MR# 1 and 6) (G1022). 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 of 42 CFR§484.110 Clinical Records.

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 was complete and included clinical notes for 3 of 7 (MR#'s 2, 3, and 4) records reviewed, resulting in the physician not having a clear and concise clinical picture of the patient's health status and progression towards goals. Findings include: **Agency Policy: Client Care Records (Undated) states, "Basic Record Requirements: All entries in the health record must be: 2. Recorded within 24 hours of the provision of service." MR#2: The Start of Care (SOC) was dated 6/13/20. The Plan of Care (POC) identified diagnoses of Stage 4 Pressure Ulcer Left Buttock and Paraplegia. During record review on 2/25/21, it was noted that the POC's dated 12/10/20 and 2/8/21 contained the Skilled Nursing (SN) wound care order of "SN to perform wound care per protocol as ordered by wound care specialist every visit." Over the prior 10 weeks, from the 3rd recertification on 12/10/20, the agency documented 4 weekly wound measurements on 12/10/20, 1/26/21, 2/3/21, and 2/15/21. Additionally, the recertification assessment and POC started on 2/3/21 has not been completed and both documents state "In Progress." The agency failed to follow its policy regarding wound measurement frequency and timely completion of documentation. MR#3: The Start of Care (SOC) was dated 2/9/21. The Plan of Care (POC) identified diagnoses of Parkinson's and Pressure Ulcer Left Foot Stage 2. During record review on 2/26/21, it was noted that the Licensed Practical Nurse (LPN) has not completed the visit notes for 2/15/21 and 2/18/21. The agency failed to follow its documentation policy regarding timely completion of documentation. The Adm#1 was questioned on 2/26/21 at 11:55 am and confirmed the findings stating, "I am not sure why the wound measurements were not done weekly per our protocol. Yes, those documents have not been completed yet and are late." MR#4: This patient was admitted to the agency on 11/13/2020 with diagnoses of Chronic Obstructive Pulmonary Disease (COPD), left hip osteoarthritis, and chronic left hip pain. The 11/13/20, the plan of care ordered physical therapy (PT) only services to be provided twice a week for six weeks (2w6). The record was reviewed on 2/25/21 and it noted that 7 of 8 visists were made from 11/13/20 through 12/7/20. The patient was recertified for PT only on 1/11/2021 at a frequency of 2w6. There were no additional documented PT visits for the past 80 days (12/7/20 through 2/25/21). There was no documentation to indicate the patient had declined PT visits. The clinical record was incomplete and failed to include PT notes that are due within 24 hours of services furnished as stipulated by agency policy. The findings were reviewed with and confirmed by the Administrator (Adm#1) during an interview on 2/25/21 at 2:47 p.m. Adm#1 stated, "We've tried to get him to turn in his documentation, but he just won't do it."

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 a discharge summary was sent to the physician within 5 business days of the patient's discharge for 2 of 2 (MR# 1 and 6) records reviewed in which the patient was discharged from the agency, resulting in the physician not having knowledge of the patient's health status at the time of discharge and a summary of the care received which could negatively affect the 76 patients discharged from the agency in the past 12 months. Findings include: MR#1: The Start of Care (SOC) was dated 8/29/20. The Plan of Care (POC) identified diagnoses of Diabetes Type 2 and Peripheral Vascular Disease. The Skilled Nurse completed a discharge OASIS (outcome and assessment information set) on 10/19/20. During record review on 2/24/21, it was noted that there was no documented evidence a discharge summary was sent to the physician within 5 business days of the patient's discharge. The Adm#1 was questioned on 2/26/21 at 11:35 am and confirmed the findings stating, "Yes, that was not sent to the physician within 5 business days. It was sent on 11/18/20, almost a month later." MR#6: The start of care (SOC) was 9/18/2020. The plan of care (POC) identified diagnoses of Multiple Sclerosis, Diabetes-Type 2, and Congestive Heart Failure. The discharge summary completed by physical therapy was dated 11/13/20. During review on 2/25/21, it was noted there was no documented evidence a discharge summary was sent to the physician. Further, the discharge summary failed to incorporate any findings, interventions, or progress towards goals concerning the patient's pertinent diagnoses of diabetes and congestive heart failure. During an interview with the Administrator (Adm#1) on 2/26/21 at 9:45 AM, the findings were reviewed and acknowledged. Adm#1 stated, "I can't find where we sent the discharge summary out and this summary is not good." The agency failed to send a comprehensive discharge summary timely for physician review.