Every finding on record at Ralls County Health Department and Home Health Agency

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on employee file review, and interview, the agency failed to ensure staff were provided emergency preparedness training annually for two (Employee #1 and #3) and emergency preparedness training at orientation for one (Employee #2) of three agency employee files reviewed. This deficient practice has the potential to affect the emergency preparedness practices for all agency staff. Findings included: EMPLOYEE #1 (E1): Review of the employee file showed: -Licensed as a registered nurse (RN); -Date of hire: 03/13/1989; and -No record of emergency preparedness training annually EMPLOYEE #2 (E2): Review of the employee file showed: -Licensed as a licensed practical nurse (LPN); -Date of hire: 06/28/2021; and -No record of emergency preparedness training during orientation EMPLOYEE #3 (E3): Review of the employee file showed: -Licensed as a registered nurse (RN); -Date of hire: 02/22/2011; and -No record of emergency preparedness training annually During interview on 07/28/2021 at 12:25 PM, the administrator stated the only emergency preparedness training he/she has staff complete is the National Incident Management System (NIMS) which is a test consisting of four parts.

An extended survey for Medicare certification for Ralls County Home Health Agency was completed on 07/29/2021. The agency had 1 current patient. Five condition-level deficiencies were identified during this survey: - 484.50 Condition of Participation: Patient Rights; - 484.55 Condition of Participation: Comprehensive Assessment of Patients; - 484.60 Condition of Participation: Care Planning, Coordination of Services and Quality of Care; - 484.65 Condition of Participation: Quality Assessment and Performance Improvement (QAPI); and - 484.105 Condition of Participation: Organization and Administration of Services. A COVID-19 Focused Infection Control Survey was completed in conjunction with the survey with deficiencies identified related to the Focused Infection Control Survey. A home health agency that is found out of compliance with any Condition of Participation evaluated as part of a standard survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at §484.80(f) (3) - see Tag G788. The Emergency Preparedness regulations were also reviewed as part of the Medicare certification survey. One (1) standard level deficiency was identified.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on policy review, clinical record review, observation, and interview, the agency failed to develop and provide the patient and/or representative with a written notice of patient rights that included all required information. The agency failed to provide in writing, in advance of furnishing care, the following information: - The contact information for the home health agency's current administrator (G414); - The patient has the right to participate in, be informed about, and consent or refuse care in advance of and during treatment (G434); - The patient has the right to be advised orally and in writing of financial liability and changes as soon as possible, in advance of the next home health visit (G440); and - The patient has the right to be advised of the names, addresses, and telephone numbers of federal and state-funded entities that serve the area where the patient resides (G446). The cumulative effect of these deficient practices resulted in the agency's inability to ensure that all patients and/or representatives were informed of their rights and responsibilities.

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on policy review, current patient rights information, home visit observation, and interview, the agency failed to provide the patient and representative correct contact information for the current home health agency administrator, to receive complaints in, but not limited to, one (Records/Patients #1) of one home visit conducted. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities for all agency patients/representatives. Findings included: Review of the undated patient handbook, provided by the agency on 07/26/2021, showed: If you need to voice concerns related to care, treatment or services and patient safety issues: Please call Agency Administrator or Nursing Supervisor at 573-985-7121. (No names were listed) RECORD/PATIENT #1: During a home visit observation on 07/27/2021 at 1:30 PM, review of the patient folder failed to show name of the agency administrator or name and contact information for the clinical manager. During an interview with the patient on 07/27/2021 at 1:45 PM, the patient reported he was unsure of who he would speak with but guessed that he would just call the health department and ask who to speak with. During review of findings with the administrator on 07/29/2021 at 1:05 PM, the administrator acknowledged the findings and reported that he/she will update the admission packets to include necessary information.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interview, the agency failed to provide written information regarding the patient's right to participate in, be informed about, and consent or refuse care, with respect to completion of all assessments, care to be furnished based on the comprehensive assessment, establishing and revising the plan of care, the frequency of visits, expected outcomes, any factors that could impact treatment effectiveness, and any changes in the care to be furnished prior to providing services in, but not limited to, one (Record/Patient #1) of three records reviewed. This deficient practice has the potential to affect the immediate needs, knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: Review of the agency policy titled, "Home Health Agency Services Provided" dated 08/27/ 2015 showed in part, the following: - The home health agency shall provide nursing services, which shall be under the supervision of a physician or a registered nurse and in accordance with the plan of treatment; - The registered nurse's duties shall include, but not be limited to, making the initial evaluation visit, regularly re-evaluate the client's needs, initiate the plan of treatment and necessary revisions, provide those services requiring substantial specialized nursing procedures, prepare clinical and progress notes according to the physician plan of care, inform the physician and other personnel of changes in the client's condition and needs, participate in in-service programs, supervise and teach other nursing personnel, coordinate services and make appropriate referrals; - Any therapy services offered by the home health agency, directly or an arrangement, shall be given by a qualified therapist in accordance with the plan of treatment. Medical social services shall be provided by a qualified social worker and in accordance with the plan of treatment; - A medical social worker is a person who has a master's degree from a school of social work accredited by the council of social work education and has at least one year of social work experience in a home health care setting; and - Home health aides shall have completed and passed the competency evaluation which includes a written test and a skills evaluation and to be registered with the MAHC in Jefferson City. RECORD/PATIENT #1: Review of the clinical record showed the patient's most recent recertification was 06/15/2021. The patient is a quadriplegic and requires total care to be provided around the clock. The patient is receiving skilled nursing services one time monthly for intramuscular injections of vitamin B12, assessment of left heel wound status, assessment of urostomy (surgically made opening to divert urine) and colostomy (surgically made opening in the stomach to divert bowel movement) status. Review of the plan of care (POC) dated 06/15/2021 showed in part, that the patient has difficulty buying medications, requires twenty-four hour supervision, and assistance with all activities of daily living. During a home visit on 07/27/2021 at 1:30 PM, the patient's home folder showed the following: - Financial liability statement dated 05/12/2016 with zero out of pocket responsibility of the patient; - Home health aide assignment sheet dated 05/12/2016 with frequency of visits as PRN (as needed); - Home health agency service agreement statement dated 05/12/2016 with patient selected advanced directive of out of hospital DNR (do not resuscitate); - No written wound care instructions for left heel; - No visit schedule calendar; - No name of agency administrator for complaints; and - No name or contact information for the clinical manager. During an interview with RN A on 07/27/2021 at 1:50 PM, RN A confirmed that the patient is not receiving home health aide services from the agency due to inadequate staffing. During a phone interview with the patient on 07/28/2021 at 11:00 AM, the patient reported: - It has been approximately ten years since the agency has provided home health services for assistance with showering; - Out of pocket expense for shower assistance is $25.00 each visit and currently receiving assistance three times weekly for a total of $75.00 per week; - Monthly out of pocket cost for colostomy bags (device used to collect bowel movement from surgically created opening in abdomen) is $90.00; - Monthly out of pocket expense for urostomy bag (device used to collect urine) is $70.00; - Unsure of options that may be available for extra assistance; - Medical social worker evaluation has never been offered; and - Interested in learning if eligible for additional insurance and assistance. During an interview on 07/28/2021 at 11:45 AM, the clinical manager reported the following: - The patient has been paying out of pocket for bath aide services for years; - Financial liability signed by patient on 05/12/2016 has zero dollars for out of pocket responsibility to the patient; - No signed documentation that the patient would be responsible for paying for private bath aide services; - Bath aide services were provided by RN A for previous patients; - RN A is a retired nurse that works PRN (as needed) and is the only nurse for home health other than the clinical manager; - The patient likes to be able to call and schedule showers a day prior, the agency does not have adequate staffing to accommodate the patient; - Visits would take 3 or 4 hours if the agency were to provide shower assistance during skilled nurse visits; - If a patient has a need for a medical social worker, the agency contacts the local hospital to inquire about resources; - Aware of the patient making comments that reference suicide, including the patient speaking of going to Oregon where physician assisted suicide is legal; - The physician's office was contacted and message was left with the physicians nurse; - No follow up with the physician's office documented; - No further assessment performed to assess for depression, suicidal ideation, or if a plan has been made to attempt suicide; and - Hospital social workers will only provide assistance for patient's that have recently been hospitalized and due to patient #1 not having recent hospitalization, they will not assist. During record review with the administrator on 07/29/2021 at 1:05 PM, the administrator was informed of, and acknowledged, the following: - Patient paying out of pocket for bath aide services that the agency has listed as a service that will be furnished; - Out of pocket expenses the patient is paying for regarding urostomy and colostomy supplies; - No signed financial responsible of patient paying out of pocket for bath aide and supplies; - Patient interested in social worker evaluation to determine eligibility for additional resources; and - No depression assessment or follow up regarding the patient making comments that referenced suicide, including the patient speaking of going to Oregon where physician assisted suicide is legal.

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 record review, home visit observation, and interview, the agency failed to ensure the patient was advised orally and in writing of the extent to which payment for services may be expected from Medicare, Medicaid, or any other federally-funded aid program and the charges of services that may not be covered in, but not limited to, one (Record/Patient #1) of one home visit observation. This deficient practice has the potential to adversely affect the patient's ability to pay for services for all the agency's patients. Findings included: RECORD/PATIENT #1: Review of the clinical record showed the patient's most recent recertification was 06/15/2021. The patient is a quadriplegic and requires total care to be provided around the clock. The patient is receiving skilled nursing services one time monthly for intramuscular injections of vitamin B12, assessment of left heel wound status, assessment of urostomy (surgically made opening to divert urine) and colostomy (surgically made opening in the stomach to divert bowel movement) status. Review of the plan of care (POC) dated 06/15/2021 showed in part, that the patient has difficulty buying medications, requires twenty-four hour supervision, and assistance with all activities of daily living. During a home visit on 07/27/2021 at 1:30 PM, the patient's home folder showed the financial liability statement dated 05/12/2016 with zero out of pocket responsibility of the patient. During a phone interview with the patient on 07/28/2021 at 11:00 AM, the patient reported: - Approximately ten years since the agency has provided home health services for assistance with showering; - Out of pocket expense for shower assistance is $25.00 each visit and currently receiving assistance three times weekly for a total of $75.00 per week; - Monthly out of pocket cost for colostomy bags (device used to collect bowel movement from surgically created opening in abdomen) is $90.00; - Monthly out of pocket expense for urostomy bag (device used to collect urine) is $70.00; - Unsure of options that may be available for extra assistance; - Medical social worker evaluation has never been offered; and - Interested in learning if eligible for additional insurance and assistance. During an interview on 07/28/2021 at 11:45 AM, the clinical manager reported the following: - The patient has been paying out of pocket for bath aide services for years; - Financial liability signed by patient on 05/12/2016 has zero dollars for out of pocket responsibility to the patient; and - No signed documentation that the patient would be responsible for paying for private bath aide services. During review with the administrator on 07/29/2021 at 1:05 PM, the administrator was informed of, and acknowledged, the following: - Patient paying out of pocket for bath aide services that the agency has listed as a service that will be furnished; - Out of pocket expenses the patient is paying for regarding urostomy and colostomy supplies; - No signed financial responsible of patient paying out of pocket for bath aide and supplies; and - Patient interested in social worker evaluation to determine eligibility for additional resources.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on policy review, current patient rights information and interview, the agency failed to update the written notice of patient rights to include that the patient has the right to be advised of the name, address and phone number of the current Quality Improvement Organization (QIO) that serves the area where the patient resides. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all patients served by the agency. Findings included: The agency provided an admission packet for review on 07/26/2021. The agency notice of patient rights and other information given to a patient during the initial visit failed to show accurate information for the current QIO organization. The agency listed KEPRO as the current QIO organization for their area. The current QIO is Livanta LLC. On 07/29/2021 at 1:05 PM, the findings were reviewed with the administrator. The administrator acknowledged the findings and agreed to update all admission folders to include correct information.

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 review of agency policy, clinical record review, home visit observation, and interview, the agency failed to ensure that a complete and accurate patient specific comprehensive assessment was completed for each patient. The agency failed to: - Ensure that the comprehensive assessment adequately reflected the patient's current health, psychosocial, functional, and cognitive status (G528); - Ensure the performance of an accurate and ongoing drug regimen review that included all medications the patient was currently taking (G536); and - Ensure that the comprehensive assessment was updated and revised as the patient's condition warranted (G544). The cumulative effects of these deficient practices has the potential to effect all patients served by the home health agency.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review, and interview, the agency failed to ensure the patient's current health status was assessed and documented in one (Patient/Record #1) of three records reviewed. This deficient practice has the potential to affect the identification of patient needs for all patients on service with the agency. Findings included: Review of the agency policy titled, "Home Health Agency Services Provided" dated 08/27/2015 showed in part, the following: - The home health agency shall provide nursing services, which shall be under the supervision of a physician or a registered nurse and in accordance with the plan of treatment; - The registered nurses duties shall include, but not be limited to, making the initial evaluation visit, regularly re-evaluate the client's needs, initiate the plan of treatment and necessary revisions, provide those services requiring substantial specialized nursing procedures, prepare clinical and progress notes according to the physician plan of care, inform the physician and other personnel of changes in the clients condition and needs, participate in in-service programs, supervise and teach other nursing personnel, coordinate services and make appropriate referrals. Review of the agency's policy titled, "Home Health Patient Initial Plan of Care/Recertification" dated 08/27/2015 showed in part, the following: - Once the determination for opening the patient is made or to have continued home services, the RN (registered nurse) will continue the home visit per physician orders and determine the plan of care for the initial or the next 60 day period; and - Once the re-certification visit and the oasis are complete, the RN will compile a 60 day summary of the previous certification period consisting of : BP (blood pressure) ranges, pulse ranges, temperature ranges, O2 (oxygen) saturation ranges, BS (blood sugar) ranges if applicable, wound assessments if applicable, and any other items pertinent to the patient. RECORD/PATIENT #1: Review of the most recent recertification comprehensive assessment dated 06/11/2021 showed that the client: - Had barriers to health status due to cost/out of pocket expenses, difficulty buying medications, lack of transportation to get to medical appointments, multiple co-morbidities, and he/she was discouraged; - Required total assistance with all activities of daily living; and - The clinician did not assess/document client/caregiver need for additional assistance for home health bath aide or medical social worker. The above information was reviewed with the clinical manager on 07/28/2021 at 2:31 PM. The clinical manager reported that if a patient needs a social worker and was not recently hospitalized, the clinical manager would refer the patient to the primary care physician for social worker needs. The clinical manager was not aware of the patient needing a social worker consult. The clinical manager reported that the agency is unable to offer bath aide assistance to the patient due to inadequate staffing, unable to accommodate the patient's needs with bath aide requests, and length of visits would require three to four hours per visit if the agency offered bath aide assistance from the nurse during nursing visits.

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 record review, home visit observation, and interview, the agency failed to review all of the patient's current medications to maintain an accurate/updated medication profile in, but not limited to, one (Record/Patient #1) of one home visit observations and one (Record/Patient #3) of three full record reviews. This deficient practice has the potential to affect all patients served by the agency. Findings included: The Agency did not provide a Medication policy. RECORD/PATIENT #1: Review of the clinical record showed recertification plan of care dated 06/15/2021 for skilled nursing (SN) visits ordered monthly for vitamin B12 injections, assessment of left heel wound, and assessment of urostomy (surgically made opening to divert urine) and colostomy (surgically made opening in the stomach to divert bowel movement) status. During a home visit on 07/27/2021 at 1:45 PM, the following medication discrepancies were noted: - Potassium 99 mg 1 tablet as directed (patient no longer taking vitamin supplement potassium); - Uristatin 2 tablets daily as needed for urinary tract infections (patient no longer taking for urinary tract infections); - Tums 500 mg (milligram) chewable 1 tablet daily (patient only taking as needed for indigestion); and - Ibuprofen 200 mg 1 to 2 tablets daily (patient only taking as needed for pain relief). RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 09/27/2017 with diagnosis of atrial fibrillation (irregular and often rapid heart rate), hypertension (high blood pressure) and type 2 diabetes mellitus (condition in which cells cannot use blood sugar (glucose) efficiently for energy. This happens when the cells become insensitive to insulin and the blood sugar gradually gets too high) with kidney complications. Review of the medication profile showed: - Humulin 70/30 (a long acting insulin taken to control blood sugars) subcutaneous suspension 20 units AM, once in AM, changed as of 03/30/2021; and - Metoprolol Succinate (treats high blood pressure) 100 mg (milligrams) oral tablet, extended release one tablet daily, changed as of 03/30/2021. The medication profile dated 03/10/2021 through 04/30/2021 was reconciled with the plan of care dated 03/10/2021 through 05/08/2021 and showed the following discrepancies: - Humulin 70/30 subcutaneous suspension 20 units AM and 5 units PM, once in AM, once in PM; and - Metoprolol Succinate 100 mg oral tablet, extended release one half tablet daily. On 07/28/2021 at 2:31 PM, the record and visit was reviewed with the clinical manager and he/she acknowledged the findings, stating the medications should be listed appropriately on the plan of care.

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 agency policy review, clinical record review, and interview the agency failed to ensure the patient's comprehensive assessment was up to date and revised to include change in patient's health status in one (Patient/Record #1) of three records reviewed. This deficient practice has the potential to affect the identification of patient needs for all patients on service with the agency. Findings included: Review of the agency policy titled, "Home Health Agency Services Provided" dated 08/27/2015 showed in part, the following: - The home health agency shall provide nursing services, which shall be under the supervision of a physician or a registered nurse and in accordance with the plan of treatment; - The registered nurses duties shall include, but not be limited to, making the initial evaluation visit, regularly re-evaluate the client's needs, initiate the plan of treatment and necessary revisions, provide those services requiring substantial specialized nursing procedures, prepare clinical and progress notes according to the physician plan of care, inform the physician and other personnel of changes in the clients condition and needs, participate in in-service programs, supervise and teach other nursing personnel, coordinate services and make appropriate referrals. Review of the agency's policy titled, "Home Health Patient Initial Plan of Care/Recertification" dated 08/27/2015 showed in part, the following: - Once the determination for opening the patient is made or to have continued home services, the RN (registered nurse) will continue the home visit per physician orders and determine the plan of care for the initial or the next 60 day period; and - Once the re-certification visit and the oasis are complete, the RN will compile a 60 day summary of the previous certification period consisting of : BP (blood pressure) ranges, pulse ranges, temperature ranges, O2 (oxygen) saturation ranges, BS (blood sugar) ranges if applicable, wound assessments if applicable, and any other items pertinent to the patient. RECORD/PATIENT #1: Review of the most recent recertification comprehensive assessment dated 06/11/2021 showed that the client: - Had no depression noted; - Skin assessment questions on recertification Oasis with no being answered for M1306 (does the patient have at least one unhealed pressure ulcer/injury at stage 2 or higher or designated unstageable), zero answered on M1322 (number of stage 1 pressure injuries), N/A answered on M1324 (stage of most problematic unhealed pressure ulcer/injury that is stageable), no answered on M1330 (does patient have a stasis ulcer), and no answered on M1340 (does patient have a surgical wound); and - The clinician documented in visit narrative section of recertification oasis that wound on left posterior heel was improved and a 2 cm (centimeter) bright erythema noted on right posterior heel. Review of the skilled nurse visit note dated 07/12/2021 showed that the client: - Had a lesion on back of left heel measuring 3 cm (centimeters) long by 3.2 cm wide by 2 cm deep surrounded by 2 cm macerated (moist) tissue, moderate erythema on right posterior heel measuring 1.4 cm long by 1.3 cm wide on outer posterior heel, erythema on right posterior lower leg measuring 1 cm long by 2.3 cm wide, and 6 cm erythema noted on right scapula; - Had open wounds on posterior left heel that requires skilled intervention to manage and monitor complications (no additional skilled nurse visits requested for additional monitoring); and - Visit narrative note section has documented that the patient spoke of going to Oregon where physician assisted suicide is legal (no documentation of additional depression assessments or monitoring). The above information was reviewed with the clinical manager on 07/28/2021 at 11:45 AM. The clinical manager reported being aware of the comments made by the patient about going to Oregon where physician assisted suicide is legal. The clinical manager reported that the patient goes through periods of severe depression. The clinical manager reported that he/she is unsure of any other documentation regarding the physician being contacted. The clinical manager stated that when the physician's office is contacted regarding a patient, a message is left with the physician's nurse. The clinical manager stated that the physician's office does not always contact the agency back after relaying the message to the physician. The clinical manager reported that when a patient expresses suicidal thoughts, the physician's office is contacted but they do not always assess the patient's depression to include questions as to rather or not the patient had a plan for suicide.

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 policy review, record review, home visit observation, and interview, the agency failed to: - Provide the required information in the patient's individualized plan of care (574); - Provide a visit schedule, including frequency of visits to the patient (G614); - Provide an accurate medication schedule/instructions to the patient (G616); - Provide a copy of written instructions outlining any treatments to be administered by home health agency (HHA) personnel and personnel acting on behalf of the HHA, including therapy services (G618); and - Provide the name and contact information for the clinical manager to the patient (G622). The cumulative effect of these deficient practices has the potential to affect the provision of safe care for all patients served by the agency.

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 policy review, record review, and interview, the agency failed to ensure the plan of care (POC) included diagnosis, complete wound care orders, oxygen settings, and durable medical equipment for two (Record/Patient #1 and #3) of three records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency policy titled, "Home Health Patient Initial Plan of Care/Recertification," dated 08/27/2015, showed in part: - Once the determination for opening the patient is made or to continue to have continued home services, the RN (registered nurse) will continue the home visit per physician orders and determine the plan of care for the initial or the next 60 day period; - Once the initial visit is made to open the patient, the RN will compile the information for the Plan of Care to consist of: *Diagnosis; *Medications; and *DME. - Once the re-certification visit and the Oasis are complete, the RN will compile a 60 day summary of the previous certification period consisting of: *Wound assessments (if applicable); and *Any other items pertinent to the patient. RECORD/PATIENT #1: Review of the clinical record showed: - The plan of care dated 06/15/2021 failed to include a diagnosis for a left heel wound; - Skilled nurse visit on 06/11/2021 had documentation for wound care that was provided to left heel during skilled nurse visit; - The plan of care did not include a diagnosis for urostomy (surgical procedure to divert urine); - Skilled nurse visit note on 07/12/2021 showed that the patient had a urostomy; and - The plan of care did not include DME (durable medical equipment) for ostomy and wound care supplies. RECORD/PATIENT #3: Review of the recertification assessment dated 03/05/2021 showed in part: - Respiratory status: *Abnormal breath sounds; *Dyspnea (shortness of breath); *Oxygen use, continuous: *LPM (liters per minute) 1; and *Via nasal cannula. Review of the POC dated 03/10/2021 through 05/08/2021 showed no oxygen settings of what the patient required. Review of the skilled nurse visit assessment, dated 04/13/2021, showed the following: - Oxygen use continuous at 1 LPM, via nasal cannula; and - Patient is oxygen dependent patient. During an interview on 07/28/2021 at 2:31 PM, the clinical manager stated that: - He/she agreed that the medications and treatments should be listed appropriately on the plan of care; and - The plan of care should include details regarding the supplies needed for care and management of his/her urostomy and colostomy.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on record review, home visit observation, and interview, the agency failed to ensure each patient received written information related to visit schedule/instructions in one (Record/Patient #1) of one home visit made. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 05/12/2016 with a stage three pressure ulcer to left heel and quadriplegia. Patient continued to receive services for skilled nursing to administer monthly injections of B12 (vitamin injection), assessment of wound to left heel, and assessment to urostomy (surgical urine diversion) and colostomy (surgical procedure to divert bowel movement) status. Review of the plan of care (POC) dated 06/15/2021 through 08/13/2021, showed that the physician ordered skilled nursing (SN) one time monthly for two months. Medical necessity note on POC showed for intramuscular therapy administration and skills of a professional due to inherent complexity of care. Need for evaluation of response to treatment including assessment of complications and efficacy of prescribed changes to plan of care. Patient with unstable integumentary status: prescribed changes to current plan of care requiring instruction, supervision, evaluation and assessment of efficacy or complications of prescribed changes to plan of care. The home visit made on 07/27/2021 starting at 1:30 PM, showed the home folder was reviewed and the agency failed to provide a written frequency of visits for the skilled nurse. During an interview on 07/28/2021 at 2:30 PM, the clinical manager acknowledged the findings and no further information was provided.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on record review, home visit observation, and interview, the agency failed to ensure each patient received updated/current written instructions related to the patient's medication schedule in one (Record/Patient #1) of one home visit observation. This deficient practice has the potential to affect all patients admitted to the home care agency. Findings included: RECORD/PATIENT #1: Review of the clinical record showed the patient's most recent recertification was 06/15/2021. The patient is receiving skilled nursing services one time monthly for intramuscular injections of vitamin B12, assessment of left heel wound status, assessment of urostomy (surgical urine diversion) and colostomy (surgical bowel movement diversion) status. During a home observation visit on 07/27/2021 at 1:30 PM, the home folder/book was reviewed and failed to show a current medication list. The medication list in the home was dated for the previous certification period. During an interview on 07/27/2021 at 1:50 PM, the patient stated the medications are no longer taken as instructed on the medication sheet.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on record review, home visit observation and interview, the agency failed to provide the patient/caregiver with a copy of written instructions of any treatments being administered by the agency in one (Record/Patient #1) of one home visit made. This deficient practice has the potential to affect the patient's knowledge of self-care and agency expectations in all patients served by the agency. Findings included: RECORD/PATIENT #1 Review of the POC (plan of care) dated 06/15/2021 showed: - The skilled nurse to perform left heel wound care at time of skilled nurse assessment; - Wound to be cleansed with NS (normal saline), apply alginate (an absorbent wound dressing), and cover with a bandaid, using aseptic technique; - Skilled nurse may instruct caregiver regarding wound care as needed; and - Caregiver to provide daily wound care when not done by skilled nurse. During a home observation visit on 07/27/2021 at 1:30 PM, the surveyor observed the patient's home chart. The agency failed to provide written wound care instructions. During an interview with the caregiver on 07/27/2021 at 1:50, the caregiver reported that no written wound care instructions have been provided. Caregiver reports wound care instructions verbally given and no instructions for changes in the type of wound care to be performed since sometime last year. On 07/28/2021 at 2:30 PM, the record and visit was reviewed with the clinical manager. The clinical manager acknowledged the findings.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on home visit observation, and interview, the agency failed to provide in writing the name and contact information of the clinical manager in one (Record/Patient #1) of one home visit made. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #1: During a home visit on 07/27/2021 starting at 1:30 PM, the surveyor observed the patient's home folder. The agency failed to provide in writing the name of the clinical manager. On 07/28/2021 at 2:30 PM, the record and visit was reviewed with the clinical manager. The clinical manager acknowledged the findings. On 07/29/2021 at 1:05 PM, the findings were reviewed with the administrator and the administrator acknowledged the findings.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on observation, and interview the agency failed to: - Ensure there was evidence that the agency is measuring, analyzing, and tracking quality indicators (G642); - Ensure the agency used data collected to monitor the effectiveness and safety of the services and quality of care and identifying opportunities for improvement (G644); - Ensure the agency implemented performance improvement activities (G646); - Ensure performance improvement activities focused on high risk, high volume, or problems-prone areas (G648); - Ensure that performance improvement projects are conducted and document which projects are undertaken, the reasons for the projects, and the measurable progress of the projects (G658); and - Ensure the governing body was responsible for ensuring an ongoing program for quality improvement and patient safety (G660). The cumulative effect of these deficient practices has the potential to affect the quality of care and safety of all agency patients.

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 review of agency documents, and interview, the agency failed to provide evidence that the agency was measuring, analyzing, and tracking quality indicators. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the quality assessment performance improvement (QAPI) program showed the agency failed to have documentation of measurement, analysis, and tracking of quality indicators. The agency failed to use the data to show measurable improvements in indicators and to track quality indicators to assess processes of care, agency services, and operations. Review of the board meeting minutes dated 04/27/2021, showed no meetings were held for the QAPI program because of COVID-19 and the administrator anticipates a deficiency will be given during the upcoming review. During an interview on 07/27/2021 at 5:25 PM, the administrator stated that the agency did not have a QAPI program at this time. The agency has been working on contact tracing with the positive COVID-19 cases and the home health agency (HHA) only has one current patient.

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 review of agency documentation, and interview, the agency failed to provide evidence that collection of quality data was on-going to: - Monitor the effectiveness and safety of the services and quality of care; and - Identify opportunities for improvement. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the quality assessment performance improvement (QAPI) program showed the agency failed to have documentation of on-going monitoring of data. During an interview on 07/27/2021 at 5:25 PM, the administrator stated that the agency did not have an effective QAPI program at this time. The agency has been working on contact tracing with the positive COVID cases and the home health agency only has one current patient.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on review of agency documentation, and interview, the agency failed to provide evidence that the performance improvement activities were focused on high risk, high volume, or problems-prone areas This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the quality assessment performance improvement (QAPI) program showed the agency failed to have documentation of performance improvement activities that were focused on high risk, high volume, or problems-prone areas. During an interview on 07/27/2021 at 5:25 PM, the administrator stated that the agency did not have an effective QAPI program at this time. The agency has been working on contact tracing with the positive COVID cases and the home health agency only has one current patient.

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 review of agency documentation, and interview, the agency failed to provide evidence of any performance improvement activities that were focused on high risk, high volume, or problems-prone areas. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the quality assessment performance improvement (QAPI) program showed the agency failed to have documentation of performance improvement activities that were: - Focused on high risk, high volume, or problems-prone areas; - Considered the incidence, prevalence, and severity of the problems in those areas; and - Lead to an immediate correction of any identified problem that directly or potentially threatened the health and safety of patients. During an interview on 07/27/2021 at 5:25 PM, the administrator stated that the agency did not have an effective QAPI program at this time. The agency has been working on contact tracing with the positive COVID cases and the home health agency only has one current patient.

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 review of agency documentation, and interview, the agency's Quality Assessment and Performance Improvement (QAPI) activities failed to show the agency conducted at least one performance improvement project to reflect the scope, complexity, and past performance of the agency's services/operations with measurable progress achieved. This deficient practice has the potential to affect the quality of care for all the agency's patients. Findings included: Review of the quality assessment performance improvement (QAPI) program showed the agency failed to have a performance improvement project in development, on-going, or completed in the past year. During an interview on 07/27/2021 at 5:25 PM, the administrator stated that the agency did not have an effective QAPI program at this time. The agency has been working on contact tracing with the positive COVID cases and the home health agency only has one current patient.

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 review of agency documentation, and interview, the agency failed to provide evidence that the governing body was responsible for ensuring the agency had an ongoing program for quality improvement and patient safety. This deficient practice has the potential to affect the quality of care and safety of all agency patients. Findings included: Review of the quality assessment performance improvement (QAPI) program showed the agency failed to show documentation of the governing body involvement in ensuring an ongoing program for quality improvement and patient safety. During an interview on 07/27/2021 at 5:25 PM, the administrator stated that the agency did not have an effective QAPI program at this time. The agency has been working on contact tracing with the positive COVID cases and the home health agency only has one current patient.

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, review of Covid-19 Focused Infection Control Survey Protocol, and review of the agency's policy, the facility failed to continue implementing their program for screening visitors/non-employees for COVID-19 (pandemic infection) who entered the home health agency office. This deficient practice has the potential to affect infection control needs for all visitors/non-employees, employees and patients served by the agency. Findings included: Review of the agency's policy titled, "Covid-19 Policies & Procedures," dated 03/18/2020, showed: - Due to the increased cases of Covid-19 in Missouri, the Ralls County Health Dept. & HHA (Home Health Agency) will keep the main entrance door locked and monitor for symptoms for anyone entering the building; - A list of questions is asked through the front office window with a distance of six feet between employees and the client prior to entering the building; - Do you have any of the following: *Fever greater than 100.4 F (Fahrenheit) or signs/symptoms of a fever; *Cough; *Shortness of breath; *Any other symptoms of illness; *Been around anyone with the symptoms; *Been around anyone testing positive for Covid-19 or in quarantine; *Traveled more than 50 miles from your home; - If they answer yes to any of the questions, they cannot enter the building. They can call the 24 hour hotline for further guidance at 877-435-8711; - 05/27/2020 - The questionnaire was updated and the 50 mile travel was deleted and nausea/vomiting/diarrhea was added; and - 08/11/2020 - The Ralls County Health Dept. & HHA now require a mask to enter the building as well as passing the screening questions. (Rescinded 06/01/2021) Observation on 07/26/2021 at 01:30 PM, 07/27/2021 at 10:45 AM and 07/28/2021 at 11:15 AM upon surveyor entrance to the agency for the recertification survey and review of Centers for Medicare and Medicaid Services (CMS) COVID-19 Survey Protocol, showed the agency failed to have : - Signage to indicate the need for handwashing, social distancing or other COVID-19 information; - Signage to instruct visitors/non-employees to wear a mask to enter the building. The surveyors entered the agency with appropriate face masks in place. The surveyors were greeted by staff, introductions were made and staff escorted the surveyors through a conference room where a WIC (Women/Infant/Children) clinic was being conducted on the first day of survey and then on to another conference room where the surveyors worked out of the rest of the week. Staff did not screen the surveyors for temperature or COVID-19 screening questions upon entrance on any day during the survey. During interview 07/26/2021 at 3:25 PM, the administrator said the cases of positive COVID-19 cases had increased over the weekend. During an observation on 07/27/2021 at 10:45 AM, the surveyors observed a paper sign on the HHA door that read "COVID" handwritten and had an arrow drawn below pointing to another door. The HHA was holding a COVID vaccine clinic on Wednesday, 07/27/2021 in the HHA office where the county health department has WIC clinics. During interview on 07/28/2021 at 02:31 PM, the clinical manager said the HHA did not require staff to perform any type of screening or COVID-19 prior to entering or after entering the agency for work. During interview on 07/29/20201 at 1:05 PM, the administrator said the HHA quit monitoring visitors and removed signage from the HHA door at the end of May, 2021.

Org. had partial/extended survey CFR(s): 484.80(f)(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or This ELEMENT is not met as evidenced by: Based on the results of this extended level survey, resulting in noncompliance with five Conditions of Participation: Patient rights, Comprehensive Assessment of Patients, Care Planning, Coordination of Services and Quality of Care, Quality Assessment and Performance Improvement (QAPI), and Organization and Administration of Services, the agency may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. The restriction ends 07/29/2023.

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 policy review, job description review, record review, home visit observation, and interviews, the agency failed to organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The agency must set forth, in writing, its organizational structure, including lines of authority, and services furnished. The agency failed to provide services that were in writing to be furnished. The following standard level deficiencies were cited under this condition of participation: - Clinical Manager-Oversite must include coordinating patient care, coordinating referrals, and assuring that patient needs are continually assessed (G958); - Assuring that the patient needs are continually assessed (G966); - Assuring the development, implementation, and updates of the individualized plan of care (G968); and - Services furnished must include skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, occupational therapy, medical social services or home health aide services) must be made available on a visiting basis, in a place of residence used as a patient's home. The agency must provide at least one of the services described, but may provide the second service and additional services under arrangement with another agency or organization (G982). The cumulative effect of these systemic practices resulted in the agency's inability to ensure the patient's care needs would be met.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on record review, home visit observation, and interviews, the home health agency failed to ensure that the clinical manager was available to provide oversight of all patient care services and personnel, assuring the patient needs are continually assessed, and assuring the development, implementations, and updates of the individualized plan of care on one (Record/Patient #1) of one home visit made. This deficient practice potentially placed patients at risk when the agency had no clinical manager to provide oversight and management of services. Findings included: RECORD/PATIENT #1: Review of the clinical record showed the patient's most recent recertification was 06/15/2021. The patient is a quadriplegic and requires total care to be provided around the clock. The patient is receiving skilled nursing services one time monthly for intramuscular injections of vitamin B12, assessment of left heel wound status, assessment of urostomy (surgically made opening to divert urine) and colostomy (surgically made opening in the stomach to divert bowel movement) status. Review of the plan of care (POC) dated 06/15/2021 showed in part, that the patient has difficulty buying medications, requires twenty-four hour supervision, and assistance with all activities of daily living. The POC showed patient had no advanced directives. During a home visit on 07/27/2021 at 1:30 PM, the patient's home folder showed the following: - Financial liability statement dated 05/12/2016 with zero out of pocket responsibility of the patient; - Home health aide assignment sheet dated 05/12/2016 with frequency of visits as PRN (as needed); - Home health agency service agreement statement dated 05/12/2016 with patient selected advanced directive of out of hospital DNR (do not resuscitate); - No written wound care instructions for left heel; - No visit schedule calendar; - No name of agency administrator for complaints; and - No name or contact information for the clinical manager. During a home visit on 07/27/2021 at 1:45 PM, patient stated that he/she had an advanced directive signed for DNR (do not resuscitate) and that the DNR was hanging on the side of the refrigerator in the home. Registered Nurse (RN A) stated that he/she would like to take a look at the DNR as well. DNR was signed and dated on 09/11/2013. During an interview with RN A on 07/27/2021 at 1:50 PM, RN A confirmed that the patient is not receiving home health aide services from the agency due to inadequate staffing. RN A stated that he/she is retired but works as a PRN (as needed) nurse for the agency. During an interview with the clinical manager on 07/28/2021 at 11:45 AM, the clinical manager stated that the POC should not state that the patient does not have an advanced directive due to patient having a signed DNR. The clinical manager agreed that the DNR should be on the POC and unsure of why it was not on there. The agency had a copy of the DNR in the patient's medical records and the administrator provided a copy of the DNR to the surveyors. During an interview with the clinical manager on 07/28/2021 at 2:20 PM, clinical manager reported that he/she has not been able to help with home visit's for home health patient's since March of 2020 due to COVID-19. Clinical manager stated that he/she has been assisting the health department side with Covid-19 and contact tracing. Clinical manager reported that contact tracing has consumed the majority of the clinical manager's time. The clinical manager reported that he/she has been receiving numerous referrals for home health patient's but is unable to accept referrals due to not having adequate staffing. Clinical manager reported that he/she had expressed concern and need for more staffing to the administrator on multiple occasions without success at this time. Review of findings reported to the administrator on 07/29/2021 at 1:05 PM. The administrator acknowledged the findings and no other documentation was provided.

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 policy review, record review, interview, and home visit observation, the agency failed to ensure the clinical manager supervised effective assessment of agency patients in one (Record/Patient #1) of one home visit made. The deficient practice has the potential to affect all agency patients. Findings included: Review of the agency policy titled, "Home Health Agency Services Provided" dated 08/27/ 2015 showed in part, the following: - The home health agency shall provide nursing services, which shall be under the supervision of a physician or a registered nurse and in accordance with the plan of treatment; - The registered nurses duties shall include, but not be limited to, making the initial evaluation visit, regularly re-evaluate the client's needs, initiate the plan of treatment and necessary revisions, provide those services requiring substantial specialized nursing procedures, prepare clinical and progress notes according to the physician plan of care, inform the physician and other personnel of changes in the clients condition and needs, participate in in-service programs, supervise and teach other nursing personnel, coordinate services and make appropriate referrals. RECORD/PATIENT #1: Review of skilled nurse visit note dated 07/12/2021, registered nurse (RN A) documented that the patient spoke of going to Oregon where he/she says physician assisted suicide is legal. RN A noted that the comment was reported to the patient's physician and the supervisor for RN A (clinical manager). No follow up documentation was provided. No documentation regarding the physician's response to the comments. No social work referral obtained. During a home visit on 07/27/2021 at 1:45 PM, patient stated that he/she had an advanced directive signed for DNR (do not resuscitate) and that the DNR was hanging on the side of the refrigerator in the home. RN A stated that he/she would like to take a look at the DNR as well. DNR was signed and dated on 09/11/2013. During an interview with RN A on 07/27/2021 at 1:50 PM, RN A confirmed that the patient is not receiving home health aide services from the agency due to inadequate staffing. RN A stated that he/she is retired but works as a PRN (as needed) nurse for the agency. During an interview with the clinical manager on 07/28/2021 at 11:45 AM, the clinical manager stated that the POC (plan of care) should not state that the patient does not have an advanced directive due to patient having a signed DNR. The clinical manager agreed that the DNR should be on the POC and unsure of why it was not on there. The agency had a copy of the DNR in the patient's medical records and the administrator provided a copy. The clinical manager reported not being surprised that the patient had a DNR due to recent comments about states with legal physician assisted suicide. The clinical manager reported being aware of the comments made by the patient about going to Oregon where physician assisted suicide is legal. The clinical manager reported that the patient goes through periods of severe depression. The clinical manager reported that he/she is unsure of any other documentation regarding the physician being contacted. The clinical manager stated that when the physician's office is contacted regarding a patient, a message is left with the physician's nurse. The clinical manager stated that the physician's office does not always contact the agency back after relaying the message to the physician. The clinical manager reported that when a patient expresses suicidal thoughts, the physician's office is contacted but they do not always assess the patient's depression to include questions as to rather or not the patient had a plan for suicide. During an interview with the administrator on 07/28/2021 at 1:40 PM, the administrator reported that the agency does not have a policy regarding patient's expressing suicidal thoughts. The administrator reported that the agency leaves it to the nurses' digression on the process to take if a patient makes comments regarding suicide.

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 policy review, clinical record review and interview, the agency failed to assure the development, implementation, and updates to the individualized plan of care on one (Records/Patients #1) of three patient records reviewed. This systemic deficient practice has the potential to affect the quality and continuity of care for all patients served by the agency. Findings included: Review of the agency policy titled, "Home Health Agency Services Provided" dated 08/27/ 2015 showed in part, the following: - The home health agency shall provide nursing services, which shall be under the supervision of a physician or a registered nurse and in accordance with the plan of treatment; and - The registered nurses duties shall include, but not be limited to, making the initial evaluation visit, regularly re-evaluate the client's needs, initiate the plan of treatment and necessary revisions, provide those services requiring substantial specialized nursing procedures, prepare clinical and progress notes according to the physician plan of care, inform the physician and other personnel of changes in the clients condition and needs, participate in in-service programs, supervise and teach other nursing personnel, coordinate services and make appropriate referrals. Review of the agency's policy titled, "Home Health Patient Initial Plan of Care/Recertification" dated 08/27/2015 showed in part, the following: - Once the determination for opening the patient is made or to have continued home services, the RN (registered nurse) will continue the home visit per physician orders and determine the plan of care for the initial or the next 60 day period; and - Once the re-certification visit and the oasis are complete, the RN will compile a 60 day summary of the previous certification period consisting of : BP (blood pressure) ranges, pulse ranges, temperature ranges, O2 (oxygen) saturation ranges, BS (blood sugar) ranges if applicable, wound assessments if applicable, and any other items pertinent to the patient. RECORD/PATIENT #1: Review of the clinical record showed: - The patient's most recent recertification was 06/15/2021; - Skilled nursing (SN) visits were ordered monthly for vitamin B12 injections, assessment of left heel wound, and assessment of urostomy (surgically made opening to divert urine) and colostomy (surgically made opening in the stomach to divert bowel movement) status; - Daily wound care for left heel as follows: cleanse with normal saline, apply alginate (absorbent dressing), and secure with a bandaid using aseptic technique; -Wound care orders have been the same since 10/13/2020 and no documentation of attempt to use alternative wound care dressings due to length of time wound present without healing; and - Plan of care (POC) dated 06/15/2021 showed in part, the advanced directive stating, no advanced directives (had advanced care plan discussion, but did not wish to provide advance care plan or name a surrogate decision maker). During an interview with the clinical manager on 07/28/2021 at 11:45 AM, the clinical manager stated that the POC should not state that the patient does not have an advanced directive due to patient having a signed DNR. The clinical manager agreed that the DNR should be on the POC and unsure of why it was not on there. The agency had a copy of the DNR in the patient's medical records and the administrator provided a copy. Copy of left heel wound care order provided with a date of 10/13/2020 that is consistent with the current wound care orders. No documentation provided for attempting alternative wound care dressings.

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 policy review, record review, home visit observation, and interview, the agency failed to provide at least one other service in addition to skilled nursing services, in but not limited to, one (Record/Patient #1) of one home visit observations. This deficient practice has the potential to affect all patients admitted to the home care agency. Findings included: Review of the agency policy titled, "Home Health Agency Services Provided" dated 08/27/ 2015 showed in part, the following: - The home health agency shall provide nursing services, which shall be under the supervision of a physician or a registered nurse and in accordance with the plan of treatment; - The registered nurses duties shall include, but not be limited to, making the initial evaluation visit, regularly re-evaluate the client's needs, initiate the plan of treatment and necessary revisions, provide those services requiring substantial specialized nursing procedures, prepare clinical and progress notes according to the physician plan of care, inform the physician and other personnel of changes in the clients condition and needs, participate in in-service programs, supervise and teach other nursing personnel, coordinate services and make appropriate referrals; - Any therapy services offered by the home health agency, directly or an arrangement, shall be given by a qualified therapist in accordance with the plan of treatment. Medical social services shall be provided by a qualified social worker and in accordance with the plan of treatment; - A medical social worker is a person who has a master's degree from a school of social work accredited by the council of social work education and has at least one year of social work experience and at home health care setting; and - Home health aides shall have completed and passed the competency evaluation which includes a written test and a skills evaluation and to be registered with the MAHC in Jefferson City. RECORD/PATIENT #1: Review of the clinical record showed the patient's most recent recertification was 06/15/2021. The patient is a quadriplegic and requires total care to be provided around the clock. The patient is receiving skilled nursing services one time monthly for intramuscular injections of vitamin B12, assessment of left heel wound status, assessment of urostomy (surgically made opening to divert urine) and colostomy (surgically made opening in the stomach to divert bowel movement) status. Review of the plan of care (POC) dated 06/15/2021 showed in part, that the patient has difficulty buying medications, requires twenty-four hour supervision, and assistance with all activities of daily living. Review of the skilled nurse visit dated 07/12/2021, registered nurse (RN A) documented that the patient spoke of going to Oregon where the patient said that physician assisted suicide is legal. During an interview with the patient on 07/27/2021 at 1:50 PM, the patient stated that he is paying for a private individual to provide shower assists three times a week. When the patient was asked about the home health agency not providing home health aide services for showering, the patient reported that the agency does not have the staff to provide bath aide services. During an interview with RN A on 07/27/2021 at 1:50 PM, RN A confirmed that the patient is not receiving home health aide services from the agency due to inadequate staffing. During a phone interview with the patient on 07/28/2021 at 11:00 AM, the patient reported: - Approximately ten years since the agency has provided home health aide services for assistance with showering; - Out of pocket expense for shower assistance is $25.00 each visit and currently receiving assistance three times weekly for a total of $75.00 per week; - Monthly out of pocket cost for colostomy bags (device used to collect bowel movement from surgically created opening in abdomen) is $90.00; - Monthly out of pocket expense for urostomy bag (device used to collect urine) is $70.00; - Unsure of options that may be available for extra assistance; - Medical social worker evaluation has never been offered; and - Interested in learning if eligible for additional insurance and assistance. During an interview on 07/28/2021 at 11:45 AM, the clinical manager reported the following: - The patient has been paying out of pocket for bath aide services for years; - Financial liability signed by patient on 05/12/2016 has zero dollars for out of pocket responsibility to the patient; - No signed documentation that the patient would be responsible for paying for private bath aide services; - Bath aide services were provided by RN A for previous patients; - RN A is a retired nurse that works PRN (as needed) and is the only nurse for home health other than the clinical manager; - The patient likes to be able to call and schedule showers a day prior, the agency does not have adequate staffing to accommodate the patient; - Visits would take 3 or 4 hours if the agency were to provide shower assistance during skilled nurse visits; - If a patient has a need for a medical social worker, the agency contacts the local hospital to inquire about resources; - Aware of the patient making comments that reference suicide, including the patient speaking of going to Oregon where physician assisted suicide is legal; - The physician's office was contacted and message was left with the physicians nurse; - No follow up with the physician's office documented; - No further assessment performed to assess for depression, suicidal ideation, or if a plan has been made to attempt suicide; and - Hospital social workers will only provide assistance for patient's that have recently been hospitalized and due to patient #1 not having recent hospitalization, they will not assist. During review with the administrator on 07/29/2021 at 1:05 PM, the administrator was informed of, and acknowledged, the following: - Patient paying out of pocket for bath aide services that the agency has listed as a service that will be furnished; - Out of pocket expenses the patient is paying for regarding urostomy and colostomy supplies; - No signed financial responsible of patient paying out of pocket for bath aide and supplies; - Patient interested in social worker evaluation to determine eligibility for additional resources; and - No depression assessment or follow up regarding the patient making comments that referenced suicide, including the patient speaking of going to Oregon where physician assisted suicide is legal.

Contact information for the patient CFR(s): 484.110(a)(4) Contact information for the patient, the patient's representative (if any), and the patient's primary caregiver(s); This ELEMENT is not met as evidenced by: Based on record review, and interviews, the agency failed to ensure the clinical records contained the contact information for the patient's primary caregiver in, but not limited to, one (Record/Patient #1) of three records reviewed. This deficient practice has the potential to affect the immediate needs, knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: RECORD/PATIENT #1: Review of the clinical record showed the patient's most recent recertification was 06/15/2021. The patient is a quadriplegic and requires total care to be provided around the clock. The patient is receiving skilled nursing services one time monthly for intramuscular injections of vitamin B12, assessment of left heel wound status, assessment of urostomy (surgically made opening to divert urine) and colostomy (surgically made opening in the stomach to divert bowel movement) status. Review of the plan of care (POC) dated 06/15/2021 showed in part, that the patient requires twenty-four hour supervision and assistance with all activities of daily living. No contact information for patient's caregiver including name or phone number listed on plan of care. The above findings were reviewed with the clinical manager on 07/28/2021 at 2:31 PM. The clinical manager acknowledged the findings. The clinical manager reported that he/she would inquire about listing the caregiver contact information in a notes section on the plan of care.

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 policy review, record review and interview the agency failed to ensure a complete, comprehensive transfer summary containing relevant information was sent to the other health care facility the patient was receiving care at within two business days of the agency becoming aware of the patient's transfer for two (Record/Patient #2 and #3) of two transfer/discharge records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's undated policy titled, "Agency Transfer Criteria," showed in part: - Patients will be transferred form Agency based on Agency Criteria Policy; - Transfer is necessary for the patient's welfare because the agency and the physician who is responsible for the home health plan of care agree the agency can no longer meet the patient's needs, based on the patient's acuity. The agency will arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the agency's capabilities; - Patient elects to be transferred; and - Patient/family requests transfer. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to the agency on 10/09/2012 with diagnosis of atrial fibrillation (irregular heart rate), heart failure (heart doesn't pump blood like it should), venous insufficiency (veins have trouble getting blood back up to the heart), and morbid obesity (excessive body fat). Review of the transfer summary dated 02/22/2021 showed in part, the patient's brother contacted the agency on 02/21/2021 and reported the patient had fallen and was admitted to the hospital before being transferred to an inpatient rehabilitation facility. The transfer summary notes show that report was called to the physician, the coumadin clinic, and the rehabilitation facility. The transfer summary was sent to the physician but not to the receiving facility. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to the agency on 09/27/2017 with diagnosis of atrial fibrillation (irregular and often rapid heart rate) and type 2 diabetes mellitus (condition in which cells cannot use blood sugar (glucose) efficiently for energy. This happens when the cells become insensitive to insulin and the blood sugar gradually gets too high) with kidney complications. Review of the clinical record showed a missed home health aide visit on 04/30/2021 and the comments showed the patient's sister reported that the patient had vertigo which led to a fall and the patient was taken to the hospital where he/she remains at this time. Review of the Home Health Transfer Summary showed the summary was not completed by the skilled nurse until 05/06/2021 (6 days after the patient transferred). The fax showed the transfer summary was sent to the attending physician 05/13/2021 (13 days after the patient transferred) and the agency failed to send the transfer summary to the health care facility where the patient transferred. During an interview on 07/28/2021 at 2:45 PM the clinical manager stated that transfers should be completed within two business days and acknowledged the transfer summaries were not faxed to the receiving facility.