Every finding on record at Healthmasters Inc

Reporting OASIS information CFR(s): 484.45 Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55. This CONDITION is not met as evidenced by: Based on record review and interview, the agency failed to electronically report and transmit an OASIS (Outcome and Assessment Information Set) assessment in 2 of 2 clinical records reviewed receiving skilled nursing services. (#1, 3) This practice has the potential to affect all patients. The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.45 Reporting OASIS information. The findings include: 1. Review of an undated agency policy obtained 11/17/2022, titled “Encoding and Reporting OASIS Data” stated, “… Agency will encode and electronically transmit each completed OASIS assessment to the CMS [Centers for Medicare and Medicaid Services] system within 30 days of completing the assessment of the client….” 2. Review of an undated agency policy obtained 11/17/2022, titled “Comprehensive Client Assessment” stated, “… A thorough, well-organized, comprehensive and accurate assessment … will be completed for all clients in a timely manner, but no later than five (5) calendar days after start of care. All skilled Medicare and Medicaid clients except pediatric and post-partum will have comprehensive assessments that include the OASIS data set specific to mandated time points … but will be done at least once in every sixty (60) day period….” 3. Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced an agency document titled “Home Health Plan of Care [and] Certification” for certification period 10/25/2022-12/23/2022, which indicated the agency was to provide skilled nursing services. Review failed to evidence OASIS assessment data was electronically reported and transmitted to the CMS system since the patient’s admission to the agency. 4. Clinical record review on 11/17/2022, for Patient #3, start of care 8/30/2022, evidenced an agency document titled “Home Health Plan of Care [and] Certification” for certification period 10/29/2022-12/27/2022, which indicated the agency was to provide skilled nursing services. Review failed to evidence assessment data was electronically reported and transmitted to the CMS system since the patient’s admission to the agency. 5. During an interview on 11/16/2022, at 12:43 PM, the administrator indicated she did not know how transmission of the OASIS information was reported or who did the transmission. 6. During an interview on 11/16/2022, at 12:45 PM, the alternate administrator indicated the agency was behind 5 or 6 months regarding the transmission of OASIS information. Documentation was requested regarding the most recent OASIS transmissions. O 7. During an interview on 11/17/2022, at 11:46 PM, the alternate administrator indicated he did not have any documentation regarding the transmission of OASIS 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 record review and interview, the agency failed to ensure the patients had the right to participate in, be informed of, and consent to care in advance of treatment in 2 of 2 clinical records reviewed without a current plan of care. (#5, 6) The findings include: 1. Review of an undated agency policy obtained 11/17/2022, titled “Home Care Bill of Rights” stated, “… A designated Registered Nurse/Therapist shall provide the client with a written notice of the Home Care Bill of Rights in advance of furnishing care to the client ….” 2. Clinical record review on 11/15/2022, for Patient #5, start of care 2/23/2013, failed to evidence the patient’s consent to treatment. 3. Clinical record review on 11/15/2022, for Patient #6, start of care 4/23/2013, failed to evidence the patient’s consent to treatment. 4. During an interview on 11/17/2022, at 11:04 AM, when queried where were the patients’ consents, the alternate administrator stated, “What is a consent?” The alternate administrator indicated the agency did not have patient consents but only the waiver information from the local Area of Aging. 410 IAC 17-12-3(b)(2)(D)(ii)(AA)

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 record review and interview, the agency failed to ensure the comprehensive assessment reflected the patient’s current health status in 4 of 4 clinical records reviewed with a current comprehensive assessment. (#1, #2, #3, #4) The findings include: 1. Clinical record review on 11/15/22, for patient #3, start of care 08/30/22, evidenced an agency document titled, “Oasis Assessment Details” for certification period 10/29/22-12/27/22, in subsection "Cardiovascular Status" stated weight at 65 pounds. Review evidenced Hospital A document titled, “ED to Hosp-Admission (Discharged) in Medical B Unit-CP” dated 10/29/22, which indicated patient’s weight of 162 pounds 6.4 ounces. Review evidenced Doctor B document titled, “Progress Notes” dated 11/16/22, which indicated patient’s weight at 162 pounds. Review failed to evidence the patient’s complete current health status. During an interview on 11/16/22, at 12:45 PM, the clinical supervisor indicated 65 pounds is the correct weight. The clinical supervisor indicated the weight is done at the doctor’s office due to unable to weigh patient at home. During an interview on 11/16/22, at 12:50 PM, LPN (licensed practical nurse) #2 indicated it is unknown where the weight came from on the comprehensive assessment due to unable to weigh patient at home. LPN #2 indicated the patient’s weight fluctuates and indicated the patient will look smaller. LPN #2 indicated the doctor is not notified if weight or diet changes. LPN #2 indicated patient able to have oral intake of a normal diet. Review evidenced an agency document titled, "Oasis Assessment Details" for certification period 10/29/22-12/27/22, in subsection "Gastrointestinal Status" failed to evidence peg tube (feeding tube in the stomach) enteral feeding formula, amount, frequency, size of peg tube or assessment of site. During an interview on 11/16/22, at 12:20 PM, the clinical supervisor indicated she is unsure if there was a formula for enteral feedings, and stated she thinks the peg tube is for medication only due to the patient eats. During an interview on 11/17/22, at 10:40 AM, the clinical supervisor indicated the peg tube care, formula for enteral feedings/site evaluation should be included on the comprehensive assessment. During an interview on 11/16/22, at 12:50 PM, LPN (licensed practical nurse) #2 indicated the patient is receiving the formula Nutren for the enteral feeding. 2. Clinical record review on 11/14/22, for patient #4, start of care 07/16/22, evidenced an agency document titled, "Oasis Assessment Details" for certification period 11/13/22-01/11/23, in subsection "Gastrointestinal Status" stated within normal limits, "Enteral Feeding" section is blank with peg tube information blank. During an interview on 11/16/22, at 12:00 PM, the clinical supervisor indicated there are no formula enteral feedings, the peg tube is for medication only and patient is on a regular diet. The clinical supervisor indicated the patient's mother addresses the flushes of the peg tube. During an interview on 11/17/22 at 10:40 AM, the clinical supervisor indicated the comprehensive assessment should include peg tube information. 1. Review of an undated agency policy obtained on 11/17/2022, titled “Comprehensive Client Assessment” stated, “… The Comprehensive Assessment must accurately reflect the client’s status, and must include at a minimum, the following information: The client’s current health, psychosocial, functional, and cognitive status….” 2. Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced an agency document titled “OASIS [Outcome and Assessment Information Set] Assessment Details” dated 10/24/2022, which indicated the patient had a gastrostomy (a surgically created hole in the abdomen and into the stomach to deliver nutrition, hydration, and/or medication) and a tracheostomy (a surgically created hole in the neck and into the windpipe to assist with breathing). Review failed to evidence the comprehensive assessment included an assessment of the gastrostomy and tracheostomy sites to include patency, color, drainage, and type and size of tracheostomy and gastrostomy tubes. During an interview on 11/17/2022, at 10:49 AM, the administrator indicated she did not know the type and size of the tracheostomy and indicated the comprehensive assessment should include a complete assessment of the tracheostomy and gastrostomy sites. 3. Clinical record review on 11/14/2022, for Patient #2, start of care 7/17/2022, evidenced an agency document titled “OASIS Assessment Details” and identified as the recertification assessment completed by the administrator and dated 11/13/2022. Review evidenced the assessment of the patient’s height and weight was blank. Review indicated the comprehensive assessment included the patient was assessed to not have injectable medications. Review of an agency document titled “Home Health Plan of Care [and] Certification” for certification period 9/15/2022-11/13/2022, which indicated the patient’s medications included, but were not limited to, cyanocobalamin (vitamin B12) via an intramuscular injection. During an interview on 11/16/2022, at 11:02 AM, the administrator indicated the agency cannot stand the patient up so the height and weight was not obtained and indicated she did not ask the patient/caregiver for the patient’s last known height and weight. The administrator indicated the patient does have an injectable medication and the comprehensive assessment was not correct.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to update the patient’s comprehensive assessment within 48 hours of the patient’s return to the home from the hospital admission of 24 hours or more in 2 of 2 records reviewed with hospitalizations. (#1, #3) Findings include: 3. Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced an agency document titled “OASIS Assessment Details” dated 10/24/2022, indicated the patient was admitted to the hospital on 10/14/2022 with a diagnosis of pneumonia. Review of an agency document titled “Skilled Nursing Visit Note” electronically signed by LPN #1 and dated 10/19/2022, indicated the agency provided skilled nursing services. During an interview on 11/15/2022, at 2:10 PM, Licensed Practical Nurse (LPN) #1 indicated the patient was hospitalized for 5 days. Review failed to evidence the agency updated the comprehensive assessment within 48 hours of the return home after the hospital admission. During an interview on 11/17/2022, at 11:04 AM, the administrator indicated the patient was hospitalized and stated the agency “just went with the old assessment”. 1. Record review evidenced an undated agency policy received 11/17/22, titled, “Client Reassessment/Update of Comprehensive Assessment” stated “…the comprehensive assessment will be updated within 48 hours of client return home from hospital admission of more than 24 hours…clients are reassessed when significant changes occur in their diagnosis ….” 2. Clinical record review for patient #3 on 11/15/22, start of care 08/30/22, evidenced an agency document titled, “Oasis [Outcome and Assessment Information Set] Assessment Details,” for certification period 10/29/22-12/27/22, completed on 10/28/22 that stated, “assessment being completed for recertification ….” This document failed to evidence the comprehensive assessment was updated after hospitalization from 10/29/22-11/03/22. Review on 11/17/22 from Hospital A evidenced a document dated 10/29/22, titled, “ED [emergency department] to Hosp[hospital]-Admission (Discharged) in Medical B Unit-CP” indicated a diagnosis of septic shock and emergency cystoscopy left ureteral stent placement upon admission 10/29/22 with 11/03/22 discharge date. During an interview on 11/16/22, at 1:00 PM, the clinical supervisor indicated the comprehensive assessment is only updated the last 5 days of 60 day recertification period. The clinical supervisor indicated the comprehensive assessment is not updated for change in condition or admission to new facility.

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure verbal orders were documented in the clinical record in 1 of 1 clinical record reviewed with a tracheostomy (a hole surgically inserted into the neck and into the windpipe to assist with breathing). (#1) The findings include: Review of an undated agency policy obtained 11/17/2022, titled “Physician/Allowed Non-Physician Practitioner (NPP) Orders” stated, “… When the nurse or therapist receives a verbal order from the physician … he/she shall write the order as given … The verbal order shall verify that the order was taken and verified by documenting this on the form and signing the form….” Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced an agency document titled “Skilled Nursing Visit Note” electronically signed by Licensed Practical Nurse (LPN) #1 and dated 10/13/2022, which indicated the physician gave a verbal order for Robitussin (a medication used to treat cough). Review failed to evidence the nurse wrote the verbal order given by the physician for the Robitussin. During an interview on 11/15/2022, at 2:10 PM, LPN #1 indicated she did not write the order received by the physician. During an interview on 11/17/2022, at 10:58 AM, the administrator indicated there was not a written order for the Robitussin. 410 IAC 17-14-1(a)(2)(F)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to promptly alert physician of changes in conditions that suggests the plan of care should be altered in 3 of 4 clinical records reviewed with current plans of care. (#1, 2, 3) Findings include: 5. Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced an agency document titled “Home Health Plan of Care [and] Certification” for certification period 10/25/20222-12/23/2022, which indicated the patient’s medications included, but were not limited to, alprazolam (a medication used to treat anxiety), diphenhydramine (a medication used to treat allergic reaction) Review on 11/16/2022 of an agency document titled “Drug to Drug Interactions” dated 11/16/2022 indicated a moderate drug interaction between alprazolam and diphenhydramine, which could increase the risk of confusion and drowsiness. Review failed to evidence the agency notified the physician of the drug interaction. Review of an agency document titled “OASIS [Outcome and Assessment Information Set] Assessment Details” dated 10/24/2022, indicated the patient was admitted to the hospital on 10/14/2022 with a diagnosis of pneumonia. Review failed to evidence the agency notified the physician of the patient’s hospital admission. During an interview on 11/17/2022, at 11:01 AM, the administrator indicated she did not believe the physician was made aware of the patient’s hospitalization. 6. Clinical record review on 11/14/2022, for Patient #2, start of care 7/17/2022, evidenced agency documents titled “Home Health Plan of Care [and] Certification” for certification periods 9/15/2022-11/13/2022 and 11/14/2022-1/12/2023. Review indicated the patient’s medications included, but were not limited to, coumadin (a medication to thin the blood to treat/prevent blood clots) 7.5 milligrams (mg) every Monday, Tuesday, Wednesday, and Thursday and 5mg every Friday, Saturday, and Sunday; protonix (a medication used to treat reflux), and Cymbalta (a medication used to treat depression and nerve pain). Review of a document titled “Office Visit” dated 9/22/2022, from the office of the patient’s physician responsible for the plan of care, indicated the patient’s coumadin dose was 8.5mg daily. Review failed to evidence the physician was notified of the discrepancy for the coumadin dose and need for clarification. During an interview on 11/16/2022, at 11:01 AM, the administrator indicated the patient had the PT/INR (blood tests to monitor the time it takes for the blood to clot to show the effectiveness of the coumadin) tested monthly at the hospital. The administrator indicated the agency did not request the lab results and was unaware if there had been any change to the coumadin dose. Review on 11/15/2022 of an agency document titled “Drug to Drug Interactions” dated 11/15/2022, indicated moderate drug interaction between coumadin and protonix and coumadin and Cymbalta, both causing an increase in abnormal bleeding. 7. During an interview on 11/16/2022, at 11:31 AM, the administrator indicated the agency should notify the physician of medication interactions. 410 IAC 17-13-1(a)(2) 1. Record review evidenced an undated agency policy received on 11/17/22, titled “Medical Supervision” stated “…Physician…will be contacted when… condition changes ….” 2. Record review evidenced an undated agency policy received on 11/17/22, titled “Medication Profile” stated “…At the time of admission the admission professional shall check all medications…to identify…adverse reactions, significant side effects …and contraindicated medications. The clinician shall promptly report any identified problems to the physician ….” 3. Record review evidenced an undated agency policy received on 11/7/22, titled, Medication Reconciliation” stated “…when client is discharged from the facility, the medications will be reviewed and the orders updated to reflect changes and/or continuation of previous orders…the admission professional will review medication list with the physician and confirm those medications that are to be continued or discontinued ….” 4. Clinical record review on 11/15/22, for patient #3, start of care 08/30/22, evidenced Hospital A document dated 10/29/22 titled, “ED to Hosp-Admission (Discharged) ….” indicated patient was admitted on 10/29/22. Record review evidenced an agency document titled, “Skilled Nursing Visit Note” dated 10/29/22. This document failed to evidence the physician was notified of the transfer to the hospital. During an interview on 11/16/22, at 12:30 PM the clinical supervisor indicated the patient was complaining of pain and the clinical supervisor instructed LPN (licensed practical nurse) #2 to send the patient to the emergency room. Review evidenced an undated agency document titled, “Drug to Drug Interactions” which indicated moderate drug interactions between Multivitamin and Nutren(supplement), Multivitamin and Minerals Adult Oral Liquid, Nutren and Minerals Adult Oral Liquid, Tegretol (anticonvulsant) and Tylenol (pain reliever), Tegretol and Multivitamin. This document failed to evidence the physician was notified of the drug to drug interactions. During an interview on 11/16/22, at 12:15 PM, the clinical supervisor indicated the physician should be notified if drug interactions noted. Review evidenced an agency documented dated 11/04/22 titled, “Skilled Nursing Visit Note” subsection medications indicated medication unchanged, Entapene [sic] will be given 11/04/22-11/13/22 intravenously, subsection general notes indicated patient was admitted 10/29/22-11/04/22. Review evidenced Hospital A document dated 10/29/22 titled, “ED to Hosp-Admission (Discharged) in Medical B Unit-CP” indicated admission 10/29/22-11/03/22, under discharge medications indicated medications included valproic acid, albuterol, lotrimin and botox injection under follow-up stated needs stent change/remove within 3-6 months. Review evidenced an agency document titled, “Home Health Plan of Care and Certification” for certification period 10/29/22-12/27/22 subsection medications did not include valproic acid, albuterol, lotrimin or botox injection. This document failed to evidence the medication list was reviewed with the physician and the plan of care was updated. During an interview on 11/16/22, at 1:00 PM, the clinical supervisor indicated the plan of care is not updated for change in condition or admission until recertification due at day 55-60. During an interview on 11/16/22, at 12:15 PM, the clinical supervisor indicated the medication profile should be updated if the doctor changes medication. During an interview on 11/16/22, at 12:50 PM, LPN (licensed practical nurse) #2 indicated the patient ha removal of kidney stones but was unsure of the procedure performed.

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 record review and interview, the agency failed to ensure the plan of care was revised to reflect changes in 2 of 2 clinical records reviewed with a hospitalization. (#1, 3) The findings include: 1. Clinical record review on 11/15/22, for patient #3, start of care 08/30/22, evidenced an agency document titled, “Home Health Plan of Care and Certification” for certification period 10/29/22 to 12/27/22. This document failed to reveal an updated plan of care was communicated and documented with the patient and physicians issuing orders after a change to the patient’s health status. Review evidenced Hospital A document dated 10/29/22 titled, “ED [emergency department] to Hosp [hospital]-Admission (Discharged) in Medical B Unit-CP” indicated patient admitted on 10/29/22 and discharged 11/03/22 with a diagnosis of septic shock. During an interview on 11/16/22, at 1:00 PM, the clinical supervisor indicated the plan of care was not updated for change of condition for the physician to review. 1. Review of an undated agency policy obtained 11/17/2022, titled “Plan of Care” stated, “…The plan of care will be … updated as necessary ….” 2. Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced an agency document titled “OASIS [Outcome and Assessment Information Set] Assessment Details” dated 10/24/2022, which indicated the patient was admitted to the hospital on 10/14/2022 with a diagnosis of pneumonia. Review of an agency document titled “Skilled Nursing Visit Note” electronically signed by the nurse and dated 10/19/2022, indicated the patient was taking Levofloxacin (an antibiotic used to treat infection). Review of an agency document titled “Home Health Plan of Care [and] Certification” for certification period 8/26/2022 – 10/24/2022, failed to evidence the plan of care was revised to reflect the patient’s antibiotic therapy for pneumonia. During an interview on 11/17/2022, at 11:00 AM, the administrator indicated the plan of care should have been updated to reflect the patient’s antibiotic.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to communicate to all physicians involved in the plan of care in 1 of 1 clinical record reviewed with anticoagulant medication (medication used to thin the blood to prevent/treat blood clots). (#2) The findings include: Review of an undated agency policy obtained 11/17/2022, titled “Coordination of Client Services” stated, “… Agency will communicate with ALL physicians … who are writing orders regarding the plan of care….” Clinical record review on 11/14/2022, for Patient #2, start of care 7/17/2022, evidenced agency documents titled “Home Health Plan of Care [and] Certification” for certification periods 9/15/2022-11/13/2022 and 11/14/2022-1/12/2023. Review indicated the patient’s medications included, but were not limited to, coumadin (a medication to thin the blood to treat/prevent blood clots) 7.5 milligrams (mg) every Monday, Tuesday, Wednesday, and Thursday and 5mg every Friday, Saturday, and Sunday. Review of a document titled “Office Visit” dated 9/22/2022, from the office of the patient’s physician responsible for the plan of care, indicated the patient’s coumadin dose was 8.5mg daily and indicated the patient followed-up with Person C, physician, regarding the coumadin and PT/INR (blood tests to monitor the time it takes for the blood to clot to show the effectiveness of the coumadin), which was tested monthly. Review failed to evidence communication with Person C, physician, regarding the PT/INR lab results and coumadin dose change. During an interview on 11/16/2022, at 11:01 AM, the administrator indicated the agency did not request the lab results and was unaware if there had been any change to the coumadin dose. 410 IAC 17-14-1(a)(1)(G)

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, the agency failed to show measurable improvements in indicators to improve health outcomes and quality of care. The findings include: Review of an undated agency policy obtained 11/17/2022, titled “Quality Assessment and Performance Improvement (QAPI)” stated, “… The program will be capable of showing measurable improvement in indicators that will improve health outcomes, client safety, and quality of care….” Review of the agency’s QAPI program on 11/14/2022, failed to evidence data showing the measurable improvements in indicators related to the patient health outcomes and quality of care. During an interview on 11/14/2022, at 11:06 AM, the alternate administrator indicated the agency did not have any data related to measurable improvements in indicators. 410 IAC 17-12-2(a)

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the QAPI (Quality Assessment Performance Improvement) program utilized data from the patients’ hospitalizations and infections to identify opportunities for improvement and monitor the quality of care. The findings include: 1. Review of an undated agency policy obtained 11/17/2022, titled “Quality Assessment and Performance Improvement (QAPI)” stated, “… must ensure that the program … includes the use of emergency care services, hospital admissions … The agency will identify, measure, analyze, and track quality indicators … and other relevant data to assess processes of care, services ….” 2. Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced an agency document titled “OASIS [Outcome and Assessment Information Set] Assessment Details” dated 10/24/2022, which indicated the patient was admitted to the hospital on 10/14/2022 with a diagnosis of pneumonia. During an interview on 11/15/2022, at 2:10 PM, LPN #1 indicated the patient was hospitalized for 5 days. 3. Clinical record review on 11/15/2022, for Patient #3, start of care 8/20/2022, evidenced a document from Hospital A titled “ED [Emergency Department] to Hosp [Hospital] Admission (Discharged)” dated 11/3/2022, which indicated the patient was admitted to the hospital on 10/29/2022 and discharged on 11/3/2022. Review indicated the patient had a diagnosis of sepsis (the body’s extreme response to an infection) and was discharged with antibiotics. 4. Review of the agency’s QAPI program on 11/14/2022, failed to evidence the identification and analysis of infections and hospitalizations. Review failed to evidence quality indicator data collection. 5. During an interview on 11/14/2022, at 11:06 AM, the alternate administrator indicated the agency had not developed any performance improvement activities related to the patient hospitalizations and infections. 410 IAC 17-12-2(a)

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 record review and interview, the agency failed to ensure the performance improvement activities focused on areas of high risk and high volume. The findings include: 1. Review of an undated agency policy obtained 11/17/2022, titled “Quality Assessment and Performance Improvement (QAPI)” stated, “… The agency’s performance improvement activities will focus on high risk, high volume, or problem prone areas that are specific to this agency….” 2. Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced an agency document titled “OASIS [Outcome and Assessment Information Set] Assessment Details” dated 10/24/2022, which indicated the patient was admitted to the hospital on 10/14/2022 with a diagnosis of pneumonia. During an interview on 11/15/2022, at 2:10 PM, LPN #1 indicated the patient was hospitalized for 5 days. 3. Clinical record review on 11/15/2022, for Patient #3, start of care 8/30/2022, evidenced a document from Hospital A titled “ED [Emergency Department] to Hosp [Hospital] Admission (Discharged)” dated 11/3/2022, which indicated the patient was admitted to the hospital on 10/29/2022, and discharged on 11/3/2022. Review indicated the patient had a diagnosis of sepsis (the body’s extreme response to an infection) and was discharged with antibiotics. 4. Review of the agency’s QAPI program on 11/14/2022, failed to evidence performance improvement activities based on the patient hospitalizations and infections. 5. During an interview on 11/14/2022, at 11:06 AM, the alternate administrator indicated the agency had not developed any performance improvement activities related to the patient hospitalizations and infections.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the governing body failed to ensure an ongoing program for quality improvement was implemented and maintained. The findings include: Review of an undated agency policy obtained 11/17/2022, titled “Quality Assessment and Performance Improvement (QAPI)” stated, “… The governing body is responsible for ensuring the following: … An ongoing program for quality improvement and patient safety is defined, implemented, and maintained….” Review of the agency’s QAPI program on 11/14/2022, failed to evidence the identification, collection, and analysis of quality indicators. Review failed to evidence performance improvement activities. During an interview on 11/14/2022, at 11:06 AM, the alternate administrator indicated the agency had patients with hospitalizations but did not have any data related to hospitalizations. The alternate administrator indicated the agency was still working on actions for the improvement of patient hospitalizations.

Supervise skilled professional assistants CFR(s): 484.75(c) Standard: Supervision of skilled professional assistants. This STANDARD is not met as evidenced by: Based on record review and interview, the registered nurse (RN) failed to provide supervision of the licensed practical nurse (LPN) in 1 of 2 clinical records reviewed with services provided by a licensed practical nurse. (#1) The findings include: Review of an undated agency policy obtained 11/17/2022, titled “Licensed Practical Nurse Supervision” stated, “… The Agency shall provide Licensed Practical Nurse services under the direction and supervision … To assure the quality of services provided by the Licensed Practical Nurse. … To assess competency in the clinical skill and provide opportunity for review of plan ….” Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced agency documents titled “Skilled Nursing Visit Note” electronically signed by LPN #1 and dated 10/12/2022, 10/13/2022, 10/14/2022, and 10/19/2022, which indicated the nurse suctioned the patient, administered tube feedings and water flushes through the gastrostomy tube (a tube surgically inserted in the abdomen and into the stomach to deliver nutrition, hydration, and/or medication), and administered inhaled medications via nebulizer (a medical device that delivers medications through vapor for inhalation). Review of documents completed by LPN #1 and dated 11/9/2022, 11/10/2022, 11/11/2022, 11/12/2022, and 11/14/2022, indicated the LPN performed chest physiotherapty treatment (CPT, a technique to clear the airway by performing percussions to the chest wall to loosen up mucous). Review failed to evidence the plan of care included orders for the skilled nurse to suction, administer tube feedings and flushes, administer medications, and failed to evidence a physician order for the nurse to provide tracheostomy and gastrostomy care, perform CPT, and provide tracheostomy and gastrostomy care. Review of documents dated 10/12/2022, 10/13/2022, 10/14/2022, 10/19/2022, 10/24/2022, 10/25/2022, 10/26/2022, 10/27/2022, 10/30/2022, 10/31/2022, 11/1/2022, 11/2/2022, 11/4/2022, 11/5/2022, 11/7/2022, 11/9/2022, 11/10/2022, 11/11/2022, 11/14/2022, and 11/15/2022 electronically signed by LPN #1 indicated the patient’s temperature was 97.0 degrees Fahrenheit, pulse was 68 beats per minute, respirations were 16 breaths per minute, and blood pressure was 100/70. During an interview on 11/15/2022, at 2:10 PM, LPN #1 indicated she carried over the temperature, pulse, respiration, and blood pressure from previous visits rather than document the correct vital signs for the patient because she was having problems with the electronic medical record program. Review of an agency document titled “Supervisory Visit Note” completed by the clinical manager and dated 10/24/2022, indicated LPN #1 followed client’s plan of care. Review failed to evidence the registered nurse provided LPN supervision to ensure the LPN followed the plan of care as directed. Review of an agency document titled “RN/LPN Skills Checklist” for LPN #1 signed by the clinical manager and dated 7/30/2019, failed to evidence the LPN was assessed for competency in providing CPT. During an interview on 11/16/2022, at 12:35 PM, the clinical manager indicated the LPN should have been assessed for competency for CPT. When queried why the RN assessed the LPN to provide care that followed the plan of care, the clinical manager remained silent.

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aide (HHA) was supervised to ensure the aides furnished care that followed the patient’s plan of care in 3 of 4 clinical records reviewed with home health aide services. (#2, 5, 6) The findings include: 1. Review of an undated agency policy obtained 11/17/2022, titled “Home Health Aide Supervision” stated, “… Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including but not limited to the following elements: … Following the client’s plan of care for completion of tasks assigned to a home health aide ….” 2. Clinical record review on 11/14/2022, for Patient #2, start of care 7/17/2022, evidenced an agency document titled “Aide Plan of Care” with an effective date of 9/8/2022, which indicated the home health aide was to obtain the patient’s pulse and respirations at every visit. Review indicated the home health aide should notify the case manager if the patient’s systolic blood pressure (the pressure against the arteries when the heart is contracting, represented by the top number) is greater than 160. Review indicated the home health aide should wash the patient’s hair weekly and should provide hair care and mouth care at every visit. Review of agency documents titled “Aide Visit Note” dated 11/13/2022 and 11/14/2022 failed to evidence the home health aide obtained the patient’s respirations at the evening visit and failed to obtain the patient’s pulse at the morning visit. Review indicated the home health aide washed the patient’s hair on 11/6/2022, 11/7/2022, 11/8/2022, 11/9/2022, 11/10/2022, 11/11/2022, 11/12/2022, 11/13/2022, and 11/14/2022. Review failed to evidence the home health aide completed hair care and mouth care during the evening visit on 11/6/2022, 11/7/2022, 11/8/2022, 11/9/2022, 11/10/2022, 11/11/2022, and 11/12/2022 and failed to provide mouth care during the evening visit on 11/13/2022 and 11/14/2022. Review indicated the patient’s blood pressure was 168/83 at the evening visit on 11/13/2022 and failed to indicate the home health aide notified the case manager. Review of an agency document titled “Supervisory Visit Note” completed by the clinical manager and dated 11/13/2022, indicated the aide provided services that followed the care plan. Review failed to evidence the registered nurse (RN) provided home health aide supervision to ensure the home health aides followed the aide care plan as directed. 3. Clinical record review on 11/15/2022, for Patient #5, start of care 2/23/2013, evidenced agency documents titled “Aide Visit Note” dated 10/21/2022, 10/24/2022, 10/26/2022, 10/28/2022, 10/31/2022, 11/2/2022, 11/4/2022, 11/7/2022, 11/9/2022, 11/11/2022, and 11/14/2022. Review indicated the home health aide assisted the patient with personal care and activities of daily living (ADL). Review failed to evidence a home health aide care plan. Review of an agency document titled “Supervisory Visit Note” completed by the clinical manager and dated 10/28/2022, indicated the aide provided care that followed the care plan. Review failed to evidence the RN provided home health aide supervision to ensure the aide was providing services according to the care plan. 4. Clinical record review on 11/15/2022, for Patient #6, start of care 4/22/2013, evidenced agency documents titled “Aide Visit Note” dated 10/21/2022, 10/24/2022, 10/26/2022, 10/28/2022, 10/31/2022, 11/2/2022, 11/4/2022, 11/7/2022, 11/9/2022, 11/11/2022, and 11/14/2022. Review indicated the home health aide assisted the patient with personal care and activities of daily living (ADL). Review failed to evidence a home health aide care plan and failed to evidence the home health aide provided services as directed by the aide care plan. Review of an agency document titled “Supervisory Visit Note” completed by the clinical manager and dated 10/28/2022, indicated the aide provided care that followed the care plan. Review failed to evidence the RN provided home health aide supervision to ensure the aide was providing services according to the care plan. 5. During an interview on 11/17/2022, at 11:01 AM, the administrator indicated the aide supervisory visit note should not have been marked to indicate the aide was following the care plan. 410 IAC 17-14-1(n)

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 record review and interview, the clinical manager failed to provide oversight over assuring the patient needs were continually assessed in 2 of 2 clinical records reviewed with skilled nursing services. (#1, #3) The findings include: 1. Review of an undated agency policy obtained 11/17/2022, titled “Clinical Manager” stated, “… The oversight provided by the clinical manager(s) include: … Assuring the client needs are continually assessed….” 2. Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced an agency document titled “OASIS [Outcome and Assessment Information Set] Assessment Details” dated 10/24/2022, which indicated the patient had a gastrostomy (a surgically created hole in the abdomen and into the stomach to deliver nutrition, hydration, and/or medication) and a tracheostomy (a surgically created hole in the neck and into the windpipe to assist with breathing). Review failed to evidence the comprehensive assessment included an assessment of the gastrostomy and tracheostomy sites to include patency, color, drainage, and type and size of tracheostomy and gastrostomy tubes. Review of an agency document titled “OASIS Assessment Details” dated 10/24/2022, indicated the patient was admitted to the hospital on 10/14/2022, with a diagnosis of pneumonia. Review failed to evidence the agency updated the comprehensive assessment upon the patient’s return home from the hospitalization. During an interview on 11/17/2022, at 11:04 AM, the clinical manager indicated the patient was hospitalized and stated the agency “just went with the old assessment”. 3. Clinical record review on 11/15/2022, for Patient #3, start of care 8/30/2022, evidenced a document from Hospital A dated 10/29/22, titled, “ED [Emergency Department] to Hosp [Hospital]-Admission (Discharged)”, which indicated the patient was admitted for sepsis (the body’s extreme reaction to an infection) and was discharged with IV (intravenously, through the veins) antibiotics. Review failed to evidence the agency updated the comprehensive assessment upon the patient’s return home from the hospitalization. During an interview on 11/16/22, at 12:30 PM, the clinical manager indicated she did not know who provided the IV antibiotic therapy. 4. During an interview on 11/17/2022, at 11:48 AM, the clinical manager indicated only Patient #1 had a gastrostomy.

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 manager failed to provide oversight over the development, implementation, and updates of the individualized plan of care in 2 of 2 clinical records reviewed without a current plan of care. (#5, 6) The findings include: 1. Review of an undated agency policy obtained 11/17/2022, titled “Clinical Manager” stated, “… The oversight provided by the clinical manager(s) include: … Assuring the development, implementation, and updates of the individualized plan of care….” 2. Clinical record review on 11/15/2022, for Patient #5, start of care 2/23/2013, failed to evidence a plan of care since certification period ended on 9/13/2020. 3. Clinical record review on 11/15/2022, for Patient #6, start of care 4/23/2013, failed to evidence a plan of care since certification period ended on 5/14/2020. 4. During an interview on 11/17/2022, at 11:05 AM, the clinical manger indicated the patients did not have plans of care because the patients did not have a physician. The clinical manager indicated there were no physician orders for the patients. 410 IAC 17-14-1(a)(1)

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the clinician failed to sign clinical notes in 4 of 6 clinical records reviewed (#1, 2, 5, 6) and failed to make changes in the clinical record per agency policy in 1 of 4 clinical records reviewed receiving home health aide services. (#2) The findings include: 1. Review of an undated agency policy obtained 11/17/2022, titled “Clinical Record Content/Medical Record Retention” stated, “… Any person who gives client care … must … sign the entry, complete with his or her title to authenticate an entry in the clinical record … In the event that an employee wishes to correct data, it shall be done as an amendment, without change to the original entry….” 2. Review of an undated agency policy obtained 11/17/2022, titled “Documentation of Changes to the Medical Record” stated, “… If it is necessary to make an addition to a previous entry, this must be done using an addendum to the record. The entry will be marked as an addendum and must include the date it is written and the visit date that the entry relates to….” 3. Clinical record review on 11/15/2022, for Patient #1, start of care 6/27/2022, evidenced an agency document titled “Supervisory Visit Note” completed by the clinical manager and dated 10/24/2022, which failed to evidence the signature of the clinical manager. During an interview on 11/17/2022, at 10:17 AM, the clinical manager indicated the document should be signed and dated. 4. Clinical record review on 11/14/2022, for Patient #2, start of care 7/17/2022, evidenced agency documents titled “Aide Visit Note” completed by home health aide #3 and dated 11/6/2022, 11/7/2022, 11/8/2022, 11/9/2022, 11/10/2022, 11/11/2022, 11/12/2022, 11/13/2022, and 11/14/2022, which failed to evidence a clinician’s signature. Review on 11/14/2022, evidenced an electronic agency document titled “Aide Visit Note”, completed by HHA #3 and dated 11/13/2022. Review indicated the patient’s blood pressure was 168/83. Review of the electronic agency document on 11/16/2022, indicated the patient’s blood pressure was now 128/83 for the HHA 11/13/2022, visit. Review failed to evidence corrected blood pressure was completed without changing the original document and corrected per the agency’s policy. During an interview on 11/16/2022, at 11:35 AM, HHA #3 indicated she changed the blood pressure the previous day and did not make an amendment to the original document. During an interview at the entrance conference on 11/14/2022, at 10:31 AM, the alternate administrator indicated the agency had not had any issues with needing to make corrections in the clinical record and was unsure of the process clinicians should take if needing to make a correction. 5. Clinical record review on 11/15/2022, for Patient #5, start of care 2/23/2013, evidenced agency documents titled “Aide Visit Note” dated 10/24/2022, 10/26/2022, 10/28/2022, 10/31/2022, 11/2/2022, 11/4/2022, 11/7/2022, 11/9/2022, 11/11/2022, and 11/14/2022. Review failed to evidence the home health aide signed the visit notes. Review indicated the patient’s pulse was 22 beats per minute on 10/24/2022, 26 beats per minute on 10/31/2022, and 32 beats per minute on 11/14/2022 and indicated the respirations were 74 breaths per minute on 10/24/2022, 76 breaths per minute on 10/31/2022, and 78 breaths per minute on 11/14/2022. 6. Clinical record review on 11/15/2022, for Patient #6, start of care 4/22/2013, evidenced agency documents titled “Aide Visit Note” dated 10/24/2022, 10/26/2022, 10/28/2022, 10/31/2022, 11/2/2022, 11/4/2022, 11/7/2022, 11/9/2022, 11/11/2022, and 11/14/2022. Review failed to evidence the home health aide signed the visit notes. Review indicated the patient’s pulse was 26 beats per minute on 11/14/2022 and 11/16/2022 and indicated the respirations were 74 breaths per minute on 11/14/2022 and 76 breaths per minute on 11/16/2022. 7. During an interview on 11/16/2022, at 11:28 AM, the alternate administrator indicated the agency has never insisted the staff sign their notes. 8. During an interview on 11/17/2022, at 11:03 AM, the administrator indicated the pulse and respirations were not documented correctly. 410 IAC 17-15-1(a)(7)

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to have at least one performance improvement project either in development, on-going or completed. The findings include: An undated agency policy received on 9/13/2022, titled "Quality Assessment & Performance Improvement Plan" indicated the agency would establish and maintain an ongoing Quality Assessment & Performance Improvement (QAPI) program. Record review evidenced an agency document titled, "QAPI MEETING", dated 8/20/2022, which stated, " ... The governing body is responsible for ensuring the following: a. That an ongoing program for quality improvement annd patient safety is defined, implemented and maintained b. Healthmasters, Inc quality and assessment performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness...." During an interview on 9/13/2022 at 11:41 AM, the alternate administrator indicated the QAPI meeting minutes was the only new QAPI documentation since the last survey. When queried, the alternate administrator indicated the agency had not yet developed a performance improvement project.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the home health aide (HHA) provided services included in the plan of care in 2 of 5 records reviewed receiving only home health aide services (#2, 6). The findings include: 1. An undated policy received 9/14/2022 titled, "Home Health Aide: Documentation" stated, " ... Home Health Aides will document care / services provided on the home health aide charting form ... The original documentation shall be filed in the clinical record...." Clinical record review for patient #6 on 9/13/2022 evidenced a plan of care for certification period 8/26/2022 to 10/24/2022, which stated, " ... Home Health Aide Orders ... Provide / Assist with Personal Care and assistance with ADL's [activities of daily living]...." Review of the plan of care failed to evidence specific patient care instructions for the HHA. Review of the patient's electronic medical record (Alora) failed to evidence any HHA visit notes for certification period 8/26/2022 to 10/24/2022. Clinical record review evidenced an agency document titled, "CareConnect Visit Report" received from the alternate administrator on 9/14/2022. The report evidenced a list of visit dates and times made by HHA 1 for patient #6, from 9/1/2022 to 9/9/2022. The report failed to evidence tasks performed at each visit. During an interview on 9/14/2022 at 12:23 PM, the administrator indicated the HHA should document what tasks are completed in Alora at the end of each visit. When informed of the findings, the administrator was silent. During an interview on 9/14/2022 at 1:30 PM, the alternate administrator indicated he wasn't sure why HHA 1's documentation did not include what was done at each visit, but he was going to contact Alora to try to figure it out. 2. Clinical record review on 9/9/2022 for patient #2 evidenced an HHA Care Plan which indicated the HHA was to check the patient's blood pressure at each visit. Review of the HHA notes from daily visits from 7/17/2022 to 9/7/2022 failed to evidence any patient blood pressures. During an interview on 9/13/2022 at 12:34 PM, when queried, the administrator indicated the HHA should document the patient's blood pressure from each visit in the visit note.

An Emergency Preparedness survey was conducted by the Indiana Department of Health in accordance with 42 CFR §484.102 for a Home Health Provider and Suppliers. Survey Dates: 5/31 (survey entrance was attempted, but agency was unstaffed/locked, and surveyor was unable to reach agency staff by phone due to "voicemail full"); and 6/6, 6/7, 6/8, 6/9, 6/10, and 6/13 (2022). Census: 7 At this Emergency Preparedness survey, Healthmasters Inc. was found to be out of compliance with Conditions of Participation 42 CFR §484.102: Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers, including staffing and the implementation of staffing during a pandemic. Quality Review Completed on 07/13/2022 by SFF

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to maintain an emergency preparedness plan that was reviewed and/or updated at least every 2 years (see tag E0004); ensured the plan included a current facility-based or community-based risk assessment, to include the COVID-19 pandemic; or strategies for addressing emergency events identified by the risk assessment (see tag E0006); maintained current policies and procedures, with review and update(s) at least every 2 years (see tag E0013); developed a procedure to follow up with on-duty staff and patients to determine services that were needed, in the event that there was an interruption in services during or due to an emergency (see tag E0021); developed and maintained an emergency preparedness communication plan which included the use of volunteers or other emergency staffing in the event of an emergency to ensure the healthcare needs of the patients were met (see tag E0024); developed and maintained an emergency preparedness communication plan which included names and contact information for other entities providing services under arrangement (E0030); developed and maintained an emergency preparedness communication plan which included primary and alternate means for communicating with agency staff (E0032); developed and maintained an emergency preparedness training and testing program, that must be reviewed and/or updated at least every 2 years (see tag E0036); ensured emergency preparedness training was provided at least every 2 years, or more often as needed, or maintained documentation of all emergency preparedness training (see tag E0037); or conducted exercises to test the emergency plan annually (E0039). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment and resulted in the agency being found out of compliance with the condition 42 CFR §484.102: Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers, including staffing and the implementation of staffing during a pandemic.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(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 record review and interview, the home health agency failed to maintain an emergency preparedness plan that was reviewed and/or updated at least every 2 years. Findings include: An undated agency policy received on 6/09/2022 titled "Disaster/Emergency Preparedness" indicated the agency would review the emergency plan annually, must make a good faith effort to comply with the plan during a disaster, and if unable to comply, it must document attempts to comply. During an interview on 6/13/2022 at 11:37 AM, when queried the last time the agency's emergency preparedness plan was reviewed and/or updated, person 4 (emergency preparedness manager) indicated it was reviewed about 3 years ago, and there was nothing at all done since COVID-19 started.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan included a current facility-based or community-based risk assessment, which included the COVID-19 pandemic; or strategies for addressing emergency events identified by the risk assessment or the COVID-19 pandemic. Findings include: An undated agency policy received on 6/09/2022 titled "Disaster/Emergency Preparedness" indicated the agency's emergency preparedness plan shall be based on, and include a documented community based risk assessment, and strategies for addressing emergency events identified in the risk assessments. During an interview on 6/13/2022 at 11:37 AM, when queried the last time a hazard vulnerability risk assessment (HVA) was completed/modified for the agency's patient population and geographic area(s) served, person 4 (emergency preparedness manager) indicated the HVA was old (on or about 2017), and he was unaware it must be based on, and include a documented community based HVA. When queried if there were documented strategies for all of the emergency events identified in the agency's HVA, person 4 indicated he was unaware that all events needed a contingency plan. When queried if the HVA included the COVID-19 pandemic, person 4 indicated it did not.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to maintain current emergency preparedness policies and procedures, with review and update(s) at least every 2 years. Findings include: An undated agency policy received on 6/09/2022 titled "Disaster/Emergency Preparedness" indicated the agency shall document emergency events and revise the emergency plan as needed. The policy failed to include any information about COVID-19. During an interview on 6/13/2022 at 11:37 AM, when queried when the last time the emergency preparedness program was reviewed/updated, person 4 (emergency preparedness manager) indicated it was reviewed about 3 years ago, and not at all since COVID-19 started.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, the agency's emergency preparedness policies and procedures failed to include contingency plans for provision of uninterrupted care for patients with suspected/confirmed COVID-19. Findings include: An undated agency policy received on 6/09/2022 titled "Disaster/Emergency Preparedness" failed to include contingency plans for patients with suspected/confirmed COVID-19. An agency policy titled "2022 Coronavirus [COVID-19] Policy" stated "[Patients] ... If anyone in your household in [sic] experiencing cold like symptoms ... notify staff so services can be paused ... It is vital for all of us to follow the CDC [center for disease control and prevention] recommendations ...." The document failed to include CDC recommendations to which the agency would follow, or how the patients' needs would be met. During an interview on 06/09/2022 at 2:13 PM, when queried if the agency had any other policies other than the policy titled "2022 Coronavirus [COVID-19] Policy", the administrator stated "No ....", and indicated COVID-19 was new, and It kept evolving. During an interview on 6/13/2022 at 11:37 AM, when queried when the last time the agency's emergency plan was reviewed, person 4 (emergency preparedness manager) indicated it was reviewed about 3 years ago, and not at all since COVID-19 started.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included the use of volunteers or other emergency staffing in the event of an emergency to ensure the healthcare needs of the patients were met. Findings include: An undated agency policy received on 6/09/2022 titled "Disaster/Emergency Preparedness" failed to include the procedure for, or the use of volunteers or other emergency staffing in the event of an emergency to ensure the healthcare needs of the patients were met. During an interview on 6/13/2022 at 11:37 AM, when queried if the agency had a procedure for, or a list of volunteers for staffing during an emergency, person 4 (emergency preparedness manager) indicated they did not.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(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 facilities]. 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, the home health agency failed to develop and maintain an emergency preparedness communication plan which included names and contact information for patients' physicians, or volunteers. Findings include: An undated agency policy received on 6/09/2022 titled "Disaster/Emergency Preparedness" failed to include an emergency preparedness communication plan which included names and contact information for patients' physicians, or volunteers. During an interview on 6/13/2022 at 11:37 AM, when queried if the agency's emergency preparedness communication plan included names and contact information for patients' physicians, or volunteers, person 4 (emergency preparedness manager) indicated it did not.

Primary/Alternate Means for Communication CFR(s): 484.102(c)(3) §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID's staff, Federal, State, tribal, regional, and local emergency management agencies. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to develop and maintain an emergency preparedness communication plan which included an alternate means for communicating with agency staff. Findings include: An undated agency policy received on 6/09/2022 titled "Disaster/Emergency Preparedness" indicated during an emergency, the agency shall attempt to contact staff, and it must inform the staff of a designated local radio/television designation for use during an event of loss of telephone service. During an interview on 6/13/2022 at 11:37 AM, when queried if the agency coordinated with a local radio station for emergency communication needs, the alternate administrator and person 4 indicated they did not.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to maintain an emergency preparedness training and testing program, that was reviewed and/or updated at least annually, per the agency's own policy. Findings include: An undated agency policy received on 6/09/2022 titled "Disaster/Emergency Preparedness" indicated the agency shall review the emergency plan annually, testing would occur annually. During an interview on 6/13/2022 at 11:37 AM, when queried when the last time the emergency preparedness program/plan was reviewed, person 3 (emergency preparedness manager) indicated it was reviewed about 3 years ago, and nothing at all was done since COVID-19 started.

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 record review and interview, the agency failed to ensure emergency preparedness training was provided at least annually (per the agency's own policy), or more often as needed; or maintained documentation of all emergency preparedness training. Findings include: An undated agency policy received on 6/09/2022 titled "Disaster/Emergency Preparedness" indicated agency employees would be oriented on the emergency plan during the new hire process and annually thereafter. During an interview on 6/09/2022 at 2:44 PM, employee record reviews were completed with person 3 (human resource manager) and the alternate administrator. The records failed to include documentation of any annual in-service training. When queried where annual in-service training was documented, the alternate administrator indicated it was documented in an agency in-service binder. During an interview on 6/09/2022 at 3:40 PM, when queried if the agency had a separate in-service book for training, person 3 said "Yes." During an interview on 6/13/2022 at 11:37 AM, when queried when the last time emergency preparedness training was completed with employees, person 4 indicated it was about 3 years ago. When queried if the training was documented in the emergency preparedness binder, person 3 stated "No". During an interview on 6/13/2022 at 4:08 PM, when the agency in-service binder was requested for review, the alternate administrator stated "... We had one, but I don’t know where it is ...." When queried when the last in-service was conducted, the alternate administrator stated "... I don't know ... A long time ...."

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to evidence it conducted exercises to test the emergency plan annually. Findings include: An undated agency policy received on 6/09/2022 titled "Disaster/Emergency Preparedness" indicated the agency shall execute the disaster/emergency preparedness plan annually, and participate in a full scale or table-top exercise. During an interview on 6/13/2022 at 11:37 AM, when queried when the agency last conducted a full scale or table-top exercise, person 4 (emergency preparedness manager) indicated November 2018 was the last exercise.

This visit was for a Federal Recertification and State Re-licensure Survey of a Home Health provider. Survey Dates: 5/31 (survey entrance was attempted, but agency was unstaffed/locked, and the surveyor was unable to reach agency staff by phone due to "voicemail full"); and 6/6, 6/7, 6/8, 6/9, 6/10, 6/13, and 6/17 (2022). The survey exit date was extended due to the receipt of pertinent documents requested during the on-site survey, but not received until 6/17/2022. The agency was notified of this possibility during the exit conference on 6/13/2022 at 4:10 PM. Census: 7 These deficiencies reflect State Findings cited in accordance with 410 IAC 17. See State Form for additional findings. During this Federal Recertification Survey, Healthmasters Inc. was found to be out of compliance with Conditions of Participation 42 CFR §484.55: Comprehensive Assessment of Patients; 42 CFR §484.58: Discharge Planning; 42 CFR §484.60: Care Planning, Coordination of Services, and Quality of Care; 42 CFR §484.65: Quality Assessment and Performance Improvement (QAPI); 42 CFR §484.70: Infection Prevention and Control; 42 CFR §484.80: Home Health Aide Services; 42 CFR §484.105: Organization and Administration of Services; and 42 CFR §484.110: Clinical Records. Based on the Condition-level deficiencies during the 6/13/2022 survey, your HHA was subject to a partial or extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 6/09/2022. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating or being the site of a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 6/13/2022 and continuing through 6/12/2024. Quality Reveiw Completed on 07/13/2022 by SFF

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 observation, record review, and interview, the agency failed to ensure the initial comprehensive assessment was completed by a registered nurse (RN) (#1) (see tag G514); failed to ensure the patient’s medication list was current, reviewed at least every 60 days, included all medications the patient used, the route, the dose, and/or the indications for use; and/or failed to ensure a drug regimen review was completed to identify duplicate drug therapy, for 6 of 7 clinical records reviewed (#1, 2, 3, 4, 5, 6,) (see tag G536); and failed to ensure the RN completed 2 comprehensive re-assessments for 1 of 1 home visits observed with a patient who received skilled nursing services (#1), and failed to ensure the RN completed multiple comprehensive re-assessment within the last 5 days of every 60 days beginning with the start-of-care date for 5 of 5 home health aide (HHA) only records reviewed (#2, 3, 4, 5, 6) (See tag G546); The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.55: Comprehensive Assessment of Patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the initial comprehensive assessment was completed by a registered nurse (RN) for 1 of 1 home visits observed with a patient who received skilled nursing services (#1). Findings include: An undated agency job description received on 6/07/2022, titled “Registered Nurse” indicated nursing assessment forms must be completed in a timely manner, and patients must be assessed during every home health care visit. An undated agency policy received on 6/13/2022 titled “Timeliness and Accuracy of Entries in the Clinical Record” stated “... To ensure that a current and accurate clinical record exists for each patient ... All clinicians [includes RN] have a professional and legal duty of care ... record keeping should be able to evidence ... Full account of the assessment ... Relevant information about the condition of the patient at any given time ... Complete clinical progress notes on the date service is rendered ....” An undated agency policy received on 6/09/2022 titled “Comprehensive Assessment of Patients (OASIS) [outcome assessment and information set]” stated “... A comprehensive assessment ... will be performed ... at start of care ... must be performed by a registered nurse ... in conjunction with the ... (OASIS) tool ... completed no later than five calendar days ... Components of a comprehensive assessment includes ... Head to toe assessment ... Vital Signs ... Special nutritional needs or dietary requirements and weight loss ... other symptoms assessment ... Integumentary [skin] status ... Respiratory [lungs/breathing] status ... Elimination [bowel/urinary] status ... Neuro/emotional/behavioral status ... ability to ambulate ... functional limitations ... a complete pain assessment ....” Observation of a home visit occurred on 6/09/2022 at 1:00 PM, with patient #1 and licensed practical nurse (LPN) 1. The patient presented up in a tilted wheelchair with head rest and wrap around leg rests, contractures to both hands, and ankle foot orthotics (AFOs) on both feet (braces to support feet due to foot drop/inability to hold feet up). Equipment observed included a broda chair (special shower chair), a tilt table (used to facilitate weight bearing/leg muscle strengthening), incontinence pads and adult briefs, size 14 fr (french) straight catheter kits (used to obtain urine specimens for lab testing), and g-tube (a tube inserted into the stomach for administration of nutrition, fluids, and/or medications) supplies/dressings. Observation was made of the patient’s g-tube insertion site (mic-key button- a special low-profile tube), which was clean and dressed with gauze. During this time, LPN 1 was queried to describe the patient’s condition, and the care she provided to the patient. LPN 1 indicated the patient was involved in a severe motor vehicle accident (MVA) many years ago, which resulted in a traumatic brain injury (TBI) and seizures, received supplemental g-tube feedings 4 times daily, the patient was able to eat a soft diet (soft in texture, minimal chewing needed, easy to swallow), followed commands, and she cared for this patient 10 hours daily, 5 days per week. Clinical record for patient #1 was completed on 6/13/2022, start of care date 2/09/2022. A comprehensive assessment document dated 2/09/2022, titled “OASIS ASSESSMENT DETAILS” was completed by the agency’s clinical manager (a RN). The document indicated the patient experienced pain, and reasons for hospitalization included pain management, but failed to include a comprehensive pain assessment was completed; and failed to indicate the patient’s lung sounds, bowel sounds, last bowel movement, g-tube assessment (or presence of), diet, nutrition/hydration status, psychological/behavioral status, neurological status, mental status, functional limitations, musculoskeletal status, fall risk assessment, activities permitted, or equipment/supply needs were assessed by the RN. During an interview on 6/13/2022 at 12:49 PM, when queried to describe the patient’s nutritional requirements, the clinical manager stated, “Through her tube [g-tube].” When queried if the patient received any other route (oral) of nutrition, the clinical manager stated “No.” When queried to describe what she did during the comprehensive visit on 2/09/2022, the clinical manager stated, “I do the OASIS part, check her meds, or anything that was different, then we generate the POC [plan of care].” When queried if the comprehensive document should be fully completed by the RN, the clinical manager stated “Yes.” When queried why she didn’t assess vital signs, the clinical manager indicated the LPN (LPN 1) was there too, so she “put it down”. When queried why a comprehensive pain assessment wasn’t completed (history of hospitalization for pain management and pain was identified during the assessment), the clinical manager indicated the patient hasn’t been in the hospital for pain management, and when queried, she indicated the comprehensive assessment document may be incorrect. When queried why she didn’t assess lung sounds, she stated, “I’m not sure.” When queried why she didn’t assess the patient’s last bowel movement, she stated, “I don’t know”. When queried why she didn’t assess the patient’s musculoskeletal status, she stated “Because she can’t walk.” When queried if equipment/supplies should be assessed during the comprehensive assessment, she stated, “Yes.” During an interview on 6/13/2022 at 2:13 PM, when queried what a comprehensive assessment consisted of, the clinical manager stated "My head is swimming ....", and no further information was provided. During an interview on 6/13/2022 at 3:14 PM, when queried what a comprehensive assessment consisted of, the alternate administrator (not an RN) indicated it consisted of the OASIS (OASIS tool does not include the physical assessment portion of a comprehensive assessment). The alternate administrator then handed the clinical manager a paper copy of the patient's comprehensive assessment (2/09/2022). The clinical manager was then queried, "When you do a comprehensive assessment, what does that consist of?" The clinical manager replied "Vitals." When queried if she was able to answer without looking at the document, the clinical manager stated "Probably not ... we have an order from the MD, then we take vital signs ...." When queried why she didn’t document about the g-tube, the clinical manager stated, "Well it was clean, and it was patent." When queried how she knew it was patent, the clinical manager stated "When we are pushing something in there." When queried if she administered anything into the g-tube during her assessment, she stated "No, the LPN [LPN 1] was there and she had done that already." When queried if she knew the size of the g-tube, she indicated she wasn't sure. When queried if this information should be included in the comprehensive assessment, she stated. "Yes." 17-14-1(a)(1)(A)

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the initial comprehensive assessment was completed by a registered nurse (RN) for 1 of 1 home visits observed with a patient who received skilled nursing services (#1). Findings include: An undated agency job description received on 6/07/2022, titled “Registered Nurse” indicated nursing assessment forms must be completed in a timely manner, and patients must be assessed during every home health care visit. An undated agency policy received on 6/13/2022 titled “Timeliness and Accuracy of Entries in the Clinical Record” stated “... To ensure that a current and accurate clinical record exists for each patient ... All clinicians [includes RN] have a professional and legal duty of care ... record keeping should be able to evidence ... Full account of the assessment ... Relevant information about the condition of the patient at any given time ... Complete clinical progress notes on the date service is rendered ....” An undated agency policy received on 6/09/2022 titled “Comprehensive Assessment of Patients (OASIS) [outcome assessment and information set]” stated “... A comprehensive assessment ... will be performed ... at start of care ... must be performed by a registered nurse ... in conjunction with the ... (OASIS) tool ... completed no later than five calendar days ... Components of a comprehensive assessment includes ... Head to toe assessment ... Vital Signs ... Special nutritional needs or dietary requirements and weight loss ... other symptoms assessment ... Integumentary [skin] status ... Respiratory [lungs/breathing] status ... Elimination [bowel/urinary] status ... Neuro/emotional/behavioral status ... ability to ambulate ... functional limitations ... a complete pain assessment ....” Observation of a home visit occurred on 6/09/2022 at 1:00 PM, with patient #1 and licensed practical nurse (LPN) 1. The patient presented up in a tilted wheelchair with head rest and wrap around leg rests, contractures to both hands, and ankle foot orthotics (AFOs) on both feet (braces to support feet due to foot drop/inability to hold feet up). Equipment observed included a broda chair (special shower chair), a tilt table (used to facilitate weight bearing/leg muscle strengthening), incontinence pads and adult briefs, size 14 fr (french) straight catheter kits (used to obtain urine specimens for lab testing), and g-tube (a tube inserted into the stomach for administration of nutrition, fluids, and/or medications) supplies/dressings. Observation was made of the patient’s g-tube insertion site (mic-key button- a special low-profile tube), which was clean and dressed with gauze. During this time, LPN 1 was queried to describe the patient’s condition, and the care she provided to the patient. LPN 1 indicated the patient was involved in a severe motor vehicle accident (MVA) many years ago, which resulted in a traumatic brain injury (TBI) and seizures, received supplemental g-tube feedings 4 times daily, the patient was able to eat a soft diet (soft in texture, minimal chewing needed, easy to swallow), followed commands, and she cared for this patient 10 hours daily, 5 days per week. Clinical record for patient #1 was completed on 6/13/2022, start of care date 2/09/2022. A comprehensive assessment document dated 2/09/2022, titled “OASIS ASSESSMENT DETAILS” was completed by the agency’s clinical manager (a RN). The document indicated the patient experienced pain, and reasons for hospitalization included pain management, but failed to include a comprehensive pain assessment was completed; and failed to indicate the patient’s lung sounds, bowel sounds, last bowel movement, g-tube assessment (or presence of), diet, nutrition/hydration status, psychological/behavioral status, neurological status, mental status, functional limitations, musculoskeletal status, fall risk assessment, activities permitted, or equipment/supply needs were assessed by the RN. During an interview on 6/13/2022 at 12:49 PM, when queried to describe the patient’s nutritional requirements, the clinical manager stated, “Through her tube [g-tube].” When queried if the patient received any other route (oral) of nutrition, the clinical manager stated “No.” When queried to describe what she did during the comprehensive visit on 2/09/2022, the clinical manager stated, “I do the OASIS part, check her meds, or anything that was different, then we generate the POC [plan of care].” When queried if the comprehensive document should be fully completed by the RN, the clinical manager stated “Yes.” When queried why she didn’t assess vital signs, the clinical manager indicated the LPN (LPN 1) was there too, so she “put it down”. When queried why a comprehensive pain assessment wasn’t completed (history of hospitalization for pain management and pain was identified during the assessment), the clinical manager indicated the patient hasn’t been in the hospital for pain management, and when queried, she indicated the comprehensive assessment document may be incorrect. When queried why she didn’t assess lung sounds, she stated, “I’m not sure.” When queried why she didn’t assess the patient’s last bowel movement, she stated, “I don’t know”. When queried why she didn’t assess the patient’s musculoskeletal status, she stated “Because she can’t walk.” When queried if equipment/supplies should be assessed during the comprehensive assessment, she stated, “Yes.” During an interview on 6/13/2022 at 2:13 PM, when queried what a comprehensive assessment consisted of, the clinical manager stated "My head is swimming ....", and no further information was provided. During an interview on 6/13/2022 at 3:14 PM, when queried what a comprehensive assessment consisted of, the alternate administrator (not an RN) indicated it consisted of the OASIS (OASIS tool does not include the physical assessment portion of a comprehensive assessment). The alternate administrator then handed the clinical manager a paper copy of the patient's comprehensive assessment (2/09/2022). The clinical manager was then queried, "When you do a comprehensive assessment, what does that consist of?" The clinical manager replied "Vitals." When queried if she was able to answer without looking at the document, the clinical manager stated "Probably not ... we have an order from the MD, then we take vital signs ...." When queried why she didn’t document about the g-tube, the clinical manager stated, "Well it was clean, and it was patent." When queried how she knew it was patent, the clinical manager stated "When we are pushing something in there." When queried if she administered anything into the g-tube during her assessment, she stated "No, the LPN [LPN 1] was there and she had done that already." When queried if she knew the size of the g-tube, she indicated she wasn't sure. When queried if this information should be included in the comprehensive assessment, she stated. "Yes."

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the registered nurse (RN) failed to ensure the patient’s medication list was current, reviewed at least every 60 days, included all medications the patient used, the route, the dose, and/or the indications for use; and/or failed to ensure a drug regimen review was completed to identify duplicate drug therapy, for 6 of 7 clinical records reviewed (#1, 2, 3, 4, 5, 6,). Findings include: 1. An undated agency policy received on 6/09/2022, titled “Medication Profile” stated “... The medication Profile must include at least the following ... Current medications ... Dose ... Route ... Frequency ... Drug Classification [indication for use] ... Nursing ... check all medications ... to identify ... duplicate drug therapy ... The medication profile will be updated at least every 60 days ....” 2. An undated agency policy received on 6/09/2022 titled “Comprehensive Assessment of Patients (OASIS) [outcome assessment and information set]” stated “... A comprehensive assessment ... will be performed ... no earlier than five days prior to the last day of the certification period ... between and including days 56-60 ... Components of a comprehensive assessment includes ... Review of medications ....” 3. Observation of a home visit occurred on 6/09/2022 at 1:00 PM, with patient #1 and licensed practical nurse (LPN) 1. A list of the patient’s current medications was posted on the inside of a cabinet. The list revealed the patient took valproic acid (anti-seizure medication), Olly sleep gummy (sleep aid), and CBD oil (cannabidiol, a derivative of cannabis). During this visit, the patient’s plan of care for certification period 4/10/2022 – 6/08/2022, was reviewed and failed to include these medications. Clinical record for patient #1 was completed on 6/13/2022, start of care date 2/09/2022. A document titled “Home Health Plan of Care & Certification” for certification period 4/10/2022 – 6/08/2022 included a section titled “Medications”. The list failed to include any indications for use, for neither scheduled nor PRN (as needed) medications; medication tablets ordered to be administered via g-tube (a tube inserted directly into the stomach for administration of nutrition/hydration and /or medications) failed to indicate if the medication should be crushed; multivitamin oral liquid was listed twice; tylenol (acetaminophen, pain relief, fever reducer) was duplicated 5 times: “... Tylenol for Children + Adults Oral Suspension 160 MG/5ML - Every 6 hours PRN [no indication for use] - One tsp - G-Tube ... Tylenol Extra Strength Oral Solution 160 MG/5ML – ml [no dose or frequency] - G-Tube ... Tylenol (160 mg/mL Elix - Every 4 Hours PRN [no dose or indication for use] ... Tylenol - PRN - 1 Tab – [no dose or indication for use] Feeding Tube ... Tylenol Extra Strength Oral Solution 160 MG/5ML - PRN – [no dose or indication] PEG TUBE ....”; Excedrin (acetaminophen, aspirin and caffeine) Migraine was duplicated twice: “... Excedrin Migraine Oral Tablet 250-250-65 MG - Every 6 hours - Tab(s) 1 ... Excedrin Migraine Oral Tablet 250-250-65 MG - PRN - Tab(s) [no dose or indication] - Feeding Tube ....” During an interview on 6/13/2022 at 1:24 PM, when queried if medications should include indications for use, the clinical manager indicated they should. When queried what medication orders should include, the clinical manager indicated they should include the name of the drug and the reason. When queried if directions for use should include if the medication should be crushed, the clinical manager stated, “Yes.” During an interview on 6/13/2022 at 1:51 PM, when queried on the last time an RN saw the patient, the alternate administrator indicated the patient was seen in April (2022). When queried who did the comprehensive re-assessment (with medication review) that was due between 6/3/2022 – 6/08/2022, the alternate administrator indicated no visit was made (as of 6/13/2022). When queried how she performed a drug regimen review (DRR), the clinical manager indicated she looked at the patient’s medications, the patient previously saw her physician, so he ordered it. 4. Clinical record review for patient #2 was completed on 6/13/2022 (start of care date 2/23/2013). The electronic medical record (EMR) failed to evidence any non-skilled nursing assessments were made, and the last OASIS/Non-OASIS re-assessment was completed 11/20/2020. The record failed to evidence the patient’s medication list was current, and was reviewed at least every 60 days. During an interview on 6/13/2022 at 3:25 PM, when queried when the last time an RN saw this patient (#2), the clinical manager stated, “I’m not sure.” When queried if an RN completed a comprehensive re-assessment after 11/20/2020, the alternate administrator stated, “... No, I don’t see any ... No, there’s none.” 5. Clinical record review for patient #3, a HHA [home health aide] only patient, was completed on 6/13/2022 (start of care date 4/22/2013). The EMR evidenced the last comprehensive re-assessment was completed 7/11/2020. The record failed to evidence the patient’s medication list was current, and was reviewed at least every 60 days. During an interview on 6/13/2022 at 3:43 PM, when queried if she remembered the last time she saw this patient (#3), the clinical manager stated, “No.” When queried if any comprehensive re-assessments were completed after 7/11/2020, the alternate administrator stated, “No.” 6. Clinical record review for patient #4 was completed on 6/13/2022 (start of care date 4/08/2008). The EMR evidenced the last comprehensive re-assessment was completed 1/25/2022, and the last routine skilled nursing visit was 1/29/2021. The record failed to evidence the patient’s medication list was current, and was reviewed at least every 60 days. During an interview on 6/13/2022 at 3:57 PM, when queried when she last saw the patient, the clinical manager stated, “Maybe a month ... 2 months ....”, and the alternate administrator stated, “Maybe a month, 2 months ....” When queried if a comprehensive re-assessment was completed after 1/25/2022, the alternate administrator stated, “No ....”, and indicated the patient was only seen by a HHA now. 7. Clinical record review for patient #5 was completed on 6/13/2022 (start of care date 3/18/2017). The EMR evidenced the last comprehensive re-assessment was completed 2/20/2022, and no other skilled nursing visits were completed on or after 2/20/2022. The record failed to evidence the patient’s medication list was current, and was reviewed at least every 60 days. During an interview on 6/13/2022 at 3:53 PM, when queried when she last saw the patient, the clinical manager stated, “I can’t remember.” When queried if an RN completed a comprehensive re-assessment after 2/20/2022, the alternate administrator stated, “No.” 8. Clinical record review for patient #6 was completed on 6/13/2022 (start of care date 12/08/2016). The EMR evidenced the last comprehensive re-assessment was completed 7/15/2021, and no other skilled nursing visits were completed on or after 7/15/2021. The record failed to evidence the patient’s medication list was current, and was reviewed at least every 60 days. During an interview on 6/13/2022 at 3:47 PM, when queried when she last saw the patient, the clinical manager stated, “I don’t remember.” When queried if an RN completed a comprehensive re-assessment after 7/15/2021, the alternate administrator stated, “No.” 9. During an interview on 6/6/2022 at 11:55 AM, when queried the process staff followed if the patient reported a new medication, or a new medication was observed in the home, the clinical manager indicated they would add the medication to the medication profile. When queried on the agency’s process for a drug regimen review, the clinical manager indicated they checked any changes with the doctor. 410 IAC 17-14-1(a)(1)(B)

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the registered nurse (RN) completed multiple comprehensive re-assessments within the last 5 days of every 60 days beginning with the start-of-care date for 6 of 6 clinical records reviewed which required comprehensive reassessments (#1, 2, 3, 4, 5, 6). Findings include: 1. An undated agency policy received on 6/13/2022 titled “Timeliness and Accuracy of Entries in the Clinical Record” stated “... To ensure that a current and accurate clinical record exists for each patient ... All clinicians [includes RN] have a professional and legal duty of care ... record keeping should be able to evidence ... Full account of the assessment ... Relevant information about the condition of the patient at any given time ... Complete clinical progress notes on the date service is rendered ....” 2. An undated agency policy received on 6/09/2022 titled “Comprehensive Assessment of Patients (OASIS) [outcome assessment and information set]” stated “... A comprehensive assessment ... will be performed ... not less frequently than every second month ...." 3. Clinical record for patient #1 was completed on 6/13/2022, start of care date 2/09/2022. The clinical record failed to evidence a comprehensive reassessment was completed for certification period that began on 6/09/2022. During an interview on 6/13/2022 at 1:51 PM, when queried on the last time an RN saw the patient, the clinical manager indicated it was her, and asked the alternate administrator, “Didn’t they leave and go back to Mexico?” The alternate administrator indicated the patient was seen in April (2022). When queried who did the comprehensive re-assessment that was due between 6/3/2022 – 6/08/2022, the alternate administrator indicated no visit was made (as of 6/13/2022). During an interview on 06/09/2022 at 12:34 PM, when the surveyor queried why the EMR (electronic medical record) didn’t evidence a current plan of care for the certification period that began 6/09/2022, the alternate administrator indicated it should be in there (the EMR), and stated “This is unacceptable here.” At 12:38 PM, the alternate administrator stated, “Okay, that [plan of care] has not been generated ....” When queried what “generate” meant, the alternate administrator stated, “Complete it.” When queried how that process worked, the alternate administrator stated, “Let’s go into OASIS assessment [in the EMR] ... I need to generate a [sic] OASIS assessment ... because the POC [plan of care] is gonna [sic] come off of the OASIS. We’ll have to do that.” The alternate administrator is not an RN. 4. Clinical record review for patient #2, a HHA only patient, was completed on 6/13/2022 (start of care date 2/23/2013). An electronic medical record (EMR) document titled “Home Health Plan of Care & Certification” for certification period 7/16/2020 to 9/13/2020 indicated the patient received HHA services 3 times per week for 1-24 hours each visit, to help with personal care, and skilled nursing to assess and evaluate HHA supervision and OASIS assessments (comprehensive assessments). The EMR also evidenced no non-skilled assessments were completed, and the last OASIS/Non-OASIS re-assessment was completed 11/20/2020. During an interview on 6/13/2022 at 3:25 PM, when queried when the last time an RN saw this patient (#2), the clinical manager stated, “I’m not sure.” When queried if an RN completed a comprehensive re-assessment after 11/20/2020, the alternate administrator stated, “... No, I don’t see any ... No, there’s none.” 5. Clinical record review for patient #3, a HHA only patient, was completed on 6/13/2022 (start of care date 4/22/2013). An EMR document titled “Home Health Plan of Care & Certification” for certification period 3/16/2020 to 5/14/2020 indicated the patient received HHA services 3 times per week for 1-24 hours each visit, to help with personal/household care; and skilled nursing to assess and evaluate HHA performance and patient comprehensive assessments. The EMR also evidenced the last comprehensive re-assessment was completed 7/11/2020. During an interview on 6/13/2022 at 3:43 PM, during EMR review, when queried if she remembered the last time she saw this patient (#3), the clinical manager stated, “No.” When queried if any comprehensive re-assessments were completed after 7/11/2020, the alternate administrator stated, “No.” 6. Clinical record review for patient #4, a HHA only patient, was completed on 6/13/2022 (start of care date 4/08/2008). An EMR document titled “Home Health Plan of Care & Certification” for certification period 3/26/2022 to 5/24/2022 indicated the patient received HHA services 8 hours per day (not specified how many days per week); and skilled nursing every 4 weeks for vitamin B12 injections and lab draws. The EMR also evidenced the last comprehensive re-assessment was completed 1/25/2022, and the last routine skilled nursing visit was 1/29/2021. During an interview on 6/13/2022 at 3:57 PM, when queried who performed the blood draws on this patient (#4), the clinical manager indicated she did, but now the hospital does because she injured her right (dominant) arm the last time she saw this patient. When queried when she last saw the patient, the clinical manager stated, “Maybe a month ... 2 months ....”, and the alternate administrator stated, “Maybe a month, 2 months ....” When queried if a comprehensive re-assessment was completed after 1/25/2022, the alternate administrator stated, “No ....”, and indicated the patient was only seen by a HHA now. 7. Clinical record review for patient #5, a HHA only patient, was completed on 6/13/2022 (start of care date 3/18/2017). An EMR document titled “Home Health Plan of Care & Certification” for certification period 2/20/2022 to 4/20/2022 indicated the patient received HHA services 6 hours per day, 7 days per week); and skilled nursing every 30 days (not further specified), and every 56-60 days (not further specified). The EMR also evidenced the last comprehensive re-assessment was completed 2/20/2022, and no other skilled nursing visits were completed on or after 2/20/2022. During an interview on 6/13/2022 at 3:53 PM, when queried when she last saw the patient, the clinical manager stated, “I can’t remember.” When queried if an RN completed a comprehensive re-assessment after 2/20/2022, the alternate administrator stated, “No.” 8. Clinical record review for patient #6, a HHA only patient, was completed on 6/13/2022 (start of care date 12/08/2016). An EMR document titled “Home Health Plan of Care & Certification” for certification period 3/17/2021 to 5/15/2021indicated the patient received HHA services 6 hours per day (2 hours in the morning, and 6 hours in the evening), 5 days per week); and skilled nursing every 30 days (not further specified), and every 56-60 days to assess and evaluate. The EMR also evidenced the last comprehensive re-assessment was completed 7/15/2021, and no other skilled nursing visits were completed on or after 7/15/2021. During an interview on 6/13/2022 at 3:47 PM, when queried when she last saw the patient, the clinical manager stated, “I don’t remember.” When queried if an RN completed a comprehensive re-assessment after 7/15/2021, the alternate administrator stated, “No.” 410 IAC 17-14-1(a)(1)(B)

Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to develop and implement an effective discharge planning process, which included a process to assist patients (who would transfer to another home health agency, or discharged to a long-term inpatient setting) and their caregivers in selecting a post-acute care provider (see tag G562); and failed to send a discharge summary to the patient's physician upon discharge from home health services (see tag G564). This practice had the potential to affect all agency patients upon discharge. Findings include: The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.58: Discharge Planning.

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to develop and implement an effective discharge planning process, which included a process to assist patients (who would transfer to another home health agency, or discharged to a long-term inpatient setting) and their caregivers in selecting a post-acute care provider. Findings include: An undated agency policy titled "Discharge/Transfer from Service" stated, "A patient may be transferred if their service/care needs cannot be met ... The patient will be provided with the name ... and contact name at the referral organization ...." The policy failed to include how the agency would assist the patient/caregiver in selecting another home health agency or long term care facility, or what criteria would be used to assist with the selection. During an interview on 6/10/2022 at 11:00 AM, when queried about the agency’s policy and procedure review/updates as part of governing body responsibilities, the alternate administrator indicated there was nothing since a few years ago, before COVID-19 started, they were very far behind, and they had nothing to submit.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to send a discharge summary to the patient's physician upon discharge from home health services, for 1 of 1 discharged records reviewed (#7). Findings include: An undated agency policy titled "Discharge/Transfer from Service" stated, "... A completed discharge ... summary is sent to the primary care practitioner ... At determination to discharge ... Physician is to be notified that a copy of the written discharge summary is available upon request ...Discharge summary is written and in the chart ...." Clinical record review for patient #7 was completed on 6/13/2022. The electronic medical record (EMR) indicated the patient was discharged from services 4/30/2020, re-admitted 11/5/2021, recertified for services on 1/22/2022, and re-admitted again on 5/20/2022. The record failed to include a discharge summary between the dates of 1/2/2022 and 5/20/2022. During an interview on 6/13/2022 at 4:00 PM, when queried on the patient’s discharge date (prior to the 5/20/2022 re-admission), the alternate administrator indicated he wasn’t sure. When queried if the discharge summary was located in the EMR [electronic medical record], or if it was sent to the physician, the alternate administrator indicated that paperwork was on a computer disk at home. No further information was provided.

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 observation, record review, and interview, the home health agency failed to ensure the patient's plan of care was established, periodically reviewed (at least every 60 days), and signed by the certifying physician, and failed to ensure the patient received the skilled nursing services as ordered in the patient's most recent plan of care (see tag G572); the patient's plan of care failed to include all pertinent diagnoses, the types of services, supplies, and equipment required, the frequency and duration of visits to be made, functional limitations, activities permitted, nutritional requirements, all medications and treatments, safety measures to protect against injury, 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, patient and caregiver education and training, patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient, or the patient's allergies (see tag G574); all patient care orders were recorded in the plan of care (see tag G576); the registered nurse (RN) failed to conform with the physician's orders as noted on the plan of care (see tag G578); Drugs, services, and/or treatments were administered only as ordered by a physician (see tag G580); the plan of care was reviewed and revised by the certifying physician no less frequently than once every 60 days (see tag G588); all patients received a home visit schedule (see tag G614); all patients received a list of medications, including which medications the agency staff administered (see tag G616); any treatments administered by agency staff (see tag G618); or the name and contact information for the agency’s clinical manager (see tag G622). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.60 Care planning, coordination, quality of care. A standard citation was also evidenced at this level as follows: Based on record review and interview, the home health agency failed to ensure all patients had a current plan of care for 7 of 7 records reviewed (#1, 2, 3, 4, 5, 6, 7). Findings include: 1. During an interview on 6/6/2022 at 11:55 AM, when queried if the agency maintained electronic medical records (EMRs), paper records, or both, the alternate administrator indicated all clinical records were maintained in the EMR, and nothing was on paper. When queried the timeframe for clinicians to submit documentation following a home visit, the clinical manager indicated all documentation was submitted while at the patient’s home (electronically). When queried the timeframe for documents to be incorporated into the patient’s clinical record, the clinical manager stated “Immediately.” 2. An undated agency policy titled “Physician Orders/Plan of Care” stated “... Purpose: ... To ensure that each patients’ care is under the direction of the physician ... The plan [of care] is ... maintained as a part of the ... clinical record ... includes ... diagnosis, prognosis, medications ... treatments, diets, goals to be accomplished ... and equipment ... will be specific to the patient ... Orders for all disciplines shall include amount, frequency, and duration ... The physician ... will review and recertify the written plan of care at least once per episode [certification period] ....” 3. Clinical record for patient #1 was completed on 6/13/2022 (start of care date 2/09/2022). The EMR failed to include a current plan of care for certification period 6/09/2022 – 8/07/2022. During an interview on 6/09/2022 at 12:34 PM, when queried if the patient’s EMR included a plan of care for certification period 6/092022 – 8/07/2022, the alternate administrator indicated it did not. During an interview on 6/13/2022 at 1:51 PM, when queried (at a later date) if there was a current plan of care for certification period 6/092022 – 8/07/2022, the alternate administrator stated, “No.” 4. Clinical record review for patient #2 was completed on 6/13/2022 (start of care date 2/23/2013). The EMR evidenced the most recent plan of care was for certification period 1/18/2020 – 3/17/2020. During an interview on 06/09/2022 at 12:32 PM, when queried why the EMR didn’t include a plan of care any time after 2020, the alternate administrator stated, “We may have missed that ....” During an interview on 6/13/2022 at 3:25 PM, when queried if the EMR included a completed plan of care any time after 3/17/2020, the alternate administrator indicated there was not. 5. Clinical record review for patient #3 was completed on 6/13/2022 (start of care date 4/22/2013). The EMR evidenced the most recent plan of care was for certification period 3/16/2020 – 5/14/2020. During an interview on 06/09/2022 at 12:32 PM, when queried why the EMR didn’t include a plan of care any time after 2020, the alternate administrator indicated this patient hasn’t had one either, since 2020. During an interview on 6/13/2022 at 3:43 PM, when queried if the EMR included a completed plan of care any time after 5/14/2020, the alternate administrator indicated there was not. 6. Clinical record review for patient #4 was completed on 6/13/2022 (start of care date 4/08/2008). The EMR evidenced the most recent plan of care was for certification period 3/26/2022 – 5/24/2022. During an interview on 06/09/2022 at 12:43 PM, when queried to confirm there was no plan of care in the EMR after certification period ending 5/24/2022, the alternate administrator indicated there was not. During an interview on 6/13/2022 at 3:57 PM, when queried if the EMR included a completed plan of care any time after 5/22/2022, the alternate administrator indicated there was not. Clinical record review for patient #5 was completed on 6/13/2022 (start of care date 3/18/2017). The EMR evidenced the most recent plan of care was for certification period 2/20/2022 – 4/20/2022. During an interview on 06/09/2022 at 12:42 PM, the alternate administrator was queried if there was a care plan after certification period ending 4/2022, to which he stated, “Ok I see that ... Okay so you’re going to have us busy ....” During an interview on 6/13/2022 at 3:50 PM, when queried if the EMR included a completed plan of care any time after 4/20/2022, the alternate administrator indicated there was not. 7. Clinical record review for patient #6 was completed on 6/13/2022 (start of care date 12/08/2016). The EMR evidenced the most recent plan of care was for certification period 3/17/2021 – 5/15/2021. During an interview on 06/09/2022 at 12:40 PM, when queried why the patient had no plan of care after 5/2021, the alternate administrator indicated the patient didn’t, and they would have to generate one for her as well. During an interview on 6/13/2022 at 3:47 PM, when queried to confirm there was no plan of care after the certification period ending 5/15/2021, the alternate administrator stated, “That’s correct.” 8. Clinical record review for patient #7 was completed on 6/13/2022 (start of care date 5/20/2022). The most recent EMR document titled “Home Health Plan of Care & Certification” was for certification period 11/05/2021 to 1/03/2022, and indicated the start of care date as 5/22/2022. The EMR did not include a plan of care for the re-admission on 5/22/2022, for certification period 5/22/2022- 7/20/2022. During an interview on 6/07/2022 at 11:57 AM, when queried who the discharged patient was, the alternate administrator and clinical manager indicated patient #7 was currently discharged, and was with family in Mexico. During an interview on 6/10/2022 at 10:30 AM, when queried why the surveyor was told this patient was discharged, when the EMR included an admission document for 5/22/2022, and current daily skilled visit notes, to which the alternate administrator stated, “... Oh, I didn’t realize ... I have to get back in the groove ....” During an interview on 6/13/2022 at 4:00 PM, when queried when this patient was re-admitted, the alternate administrator indicated he was re-admitted about a week and a half ago, When queried if the EMR included a plan of care for this admission, the alternate administrator indicated there was not. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.60: Care Planning, Coordination of Services, and Quality of Care. 410 IAC 17-13-1(a) 410 IAC 17-13-1(a)(1)(B) 410 IAC 17-13-1(a)(1)(C ) 410 IAC 17-13-1(a)(1)(D)(i, ii, iii, vi, vii, viii, ix, x, xi, xiii) 410 IAC 17-14-1(a)(1)(H) 410 IAC 17-13-1(a)(2)

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 observation, record review, and interview, the home health agency failed to ensure the patient's plan of care was periodically reviewed (at least every 60 days); and failed to ensure the patient received the skilled nursing services as ordered in the patient's most recent plan of care for 7 of 7 clinical records reviewed (#1, 2, 3, 4, 5, 6, 7). Findings include: 1. An undated agency policy received 6/09/2022, titled “Physician Orders/Plan of Care” stated “... Purpose: ... To ensure that each patients’ care is under the direction of the physician ... The physician establishes and reviews a plan of treatment [plan of care] ... The physician sets up a plan of care, which includes ... service ... treatments ... to be provided by the agency ... The physician ... will review and recertify the written plan of care at least once per episode [certification period/every 60 days] ....” 2. Clinical record for patient #1 was completed on 6/13/2022 (start of care date 2/09/2022). The electronic medical record (EMR) evidenced a plan of care for certification period 4/10/2022 – 6/08/2022. As of 6/13/2022 (the 65th day), the patient’s plan of care was not reviewed by the physician. During an interview on 6/13/2022 at 1:51 PM, when queried if there was a current plan of care, the alternate administrator stated, “No.” 3. Clinical record review for patient #2 was completed on 6/13/2022 (start of care date 2/23/2013). The electronic medical record evidenced the most recent completed plan of care was for certification period 1/18/2020 – 3/17/2020. As of 6/13/2022 (the 877th day), the patient’s plan of care was not reviewed by the physician. An electronic medical record document titled “Home Health Plan of Care & Certification” for certification period 7/16/2020 to 9/13/2020 (not signed by the registered nurse [RN] or physician) indicated orders for skilled nursing to assess and evaluate home health aide (HHA) supervision and OASIS (outcome assessment and information set) assessments (comprehensive assessments). The EMR, the last OASIS/Non-OASIS re-assessment was completed 11/20/2020. The agency failed to provide skilled nursing services as ordered on the plan of care. During an interview on 6/13/2022 at 3:25 PM, when queried when the last time an RN saw this patient (#2), the clinical manager stated, “I’m not sure.” When queried if an RN completed a comprehensive re-assessment after 11/20/2020 (as ordered on the plan of care), the alternate administrator stated, “... No, I don’t see any ... No, there’s none.” During an interview on 6/13/2022 at 3:25 PM, when queried if the EMR included a completed plan of care any time after 3/17/2020, the alternate administrator indicated there was not. 4. Clinical record review for patient #3 was completed on 6/13/2022 (start of care date 4/22/2013). The EMR evidenced the most recent plan of care was for certification period 3/16/2020 – 5/14/2020. As of 6/13/2022 (the 819th day), the patient’s plan of care was not reviewed by the physician. During an interview on 6/13/2022 at 3:43 PM, when queried if the EMR included a completed plan of care any time after 5/14/2020, the alternate administrator indicated there was not. An EMR document titled “Home Health Plan of Care & Certification” for certification period 3/16/2020 – 5/14/2020 indicated skilled nursing orders for skilled nursing to perform patient comprehensive assessments (no frequency indicated). The EMR evidenced the last comprehensive re-assessment was completed 7/11/2020. During an interview on 6/13/2022 at 3:43 PM, when queried if she remembered the last time she saw this patient (#3), the clinical manager stated, “No.” When queried if any comprehensive re-assessments were completed after 7/11/2020, the alternate administrator stated, “No.” The agency failed to provide skilled nursing services as ordered on the plan of care. 5. Clinical record review for patient #4 was completed on 6/13/2022 (start of care date 4/08/2008). The EMR evidenced the most recent plan of care was for certification period 3/26/2022 – 5/24/2022. As of 6/13/2022 (the 79th day), the patient’s plan of care was not reviewed by the physician. During an interview on 6/13/2022 at 3:57 PM, when queried if the EMR included a completed plan of care any time after 5/22/2022, the alternate administrator indicated there was not. A document titled “Home Health Plan of Care & Certification” for certification period 3/26/2022 to 5/24/2022 indicated skilled nursing visits were ordered every 4 weeks for administration of B12 shots and lab draws for PT/INR (a blood test for therapeutic lab monitoring of a blood thinner). A home visit was conducted on 6/10/2022 at 9:25 AM, with home health aide (HHA) 1. When queried if she took blood thinners, the patient indicated she did. When queried who performed blood draws for therapeutic lab monitoring, she indicated she went to the hospital for the tests monthly. When queried if she received monthly B12 shots, and who administered them, the patient indicated she did get monthly B12 shots, and her sister administered them. During an interview on 6/13/2022 at 3:57 PM, when queried who performed monthly blood draws on the patient (#4), the clinical manager indicated she used to, but now the hospital does. When queried why, the clinical manager indicated she injured her right (dominant) arm and could no longer perform the blood draws. When queried if there was another agency nurse to perform the ordered lab draws, she indicated there was not. The agency failed to provide skilled nursing as ordered on the plan of care. 6. Clinical record review for patient #5 was completed on 6/13/2022 (start of care date 3/18/2017). The EMR evidenced the most recent plan of care was for certification period 2/20/2022 – 4/20/2022. As of 6/13/2022 (the 113th day), the patient’s plan of care was not reviewed by the physician. During an interview on 6/13/2022 at 3:50 PM, when queried if the EMR included a completed plan of care any time after 4/20/2022, the alternate administrator indicated there was not. A document titled “Home Health Plan of Care & Certification” for certification period 2/20/2022 – 4/20/2022 indicated skilled nursing orders every 30 days for HHA supervision, and every 56-60 days for comprehensive assessments. The EMR indicated the last skilled nursing comprehensive visit was performed 2/20/2022, and no other nursing visits were made. The agency failed to provide skilled nursing services as ordered on the plan of care. During an interview on 6/13/2022 at 3:55 PM, when queried the last time she saw this patient (#5), the clinical manager indicated she didn’t remember. 7. Clinical record review for patient #6 was completed on 6/13/2022 (start of care date 12/08/2016). The EMR evidenced the most recent plan of care was for certification period 3/17/2021 – 5/15/2021. As of 6/13/2022 (the 453rd day), the patient’s plan of care was not reviewed by the physician. During an interview on 06/09/2022 at 12:40 PM, when queried why the patient had no plan of care after 5/2021, the alternate administrator indicated the patient didn’t, and they would have to generate one for her as well. During an interview on 6/13/2022 at 3:47 PM, when queried to confirm there was no plan of care after the certification period ending 5/15/2021, the alternate administrator stated, “That’s correct.” 8. Clinical record review for patient #7 was completed on 6/13/2022 (start of care date 5/20/2022). The most recent EMR document titled “Home Health Plan of Care & Certification” was for certification period 11/05/2021 to 1/03/2022, and indicated a start of care date of 5/20/2022. The EMR did not include a plan of care for the re-admission on 5/20/2022. As of 6/13/2022 (the 220th day), the patient’s plan of care was not reviewed by the physician. During an interview on 6/10/2022 at 10:30 AM, when queried why the surveyor was previously told by the alternate administrator and clinical manager that this patient was discharged, but the EMR included an admission comprehensive assessment dated 5/20/2022, and current daily skilled visit notes, the alternate administrator stated, “... Oh, I didn’t realize ... I have to get back in the groove ....” During an interview on 6/13/2022 at 4:00 PM, when queried if the EMR included a plan of care for this admission (5/20/2022), the alternate administrator indicated there was not. 410 IAC 17-13-1(a)

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 observation, record review, and interview, the patient's plan of care failed to include all pertinent diagnoses, the types of services, supplies, and equipment required, the frequency and duration of visits to be made, functional limitations, activities permitted, nutritional requirements, all medications and treatments, safety measures to protect against injury, 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, patient and caregiver education and training, patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient, or the patient's allergies, for 1 of 1 home visit observed with skilled nursing services (#1). Findings include: An undated agency policy received 6/09/2022, titled “Physician Orders/Plan of Care” stated “... Purpose: ... To ensure that each patients’ care is under the direction of the physician ... The plan [of care] is ... maintained as a part of the ... clinical record ... includes ... diagnosis, prognosis, medications ... treatments, diets, goals to be accomplished ... and equipment ... will be specific to the patient ... Orders for all disciplines shall include amount, frequency, and duration ....” Observation of a home visit occurred on 6/09/2022 at 1:00 PM, with patient #1 and licensed practical nurse (LPN) 1. The patient presented up in a pressure relieving (tilting) wheelchair with head rest and wrap around leg rests, contractures to both hands, and wore ankle foot orthotics (AFOs) on both feet (braces to support feet due to foot drop/inability to hold feet up). Equipment observed included a tilt table (used to facilitate weight bearing/leg muscle strengthening [a therapy modality]), incontinence pads and adult briefs, size 14 fr (french) straight catheter kits (used to obtain urine specimens for lab testing), and g-tube (a tube inserted into the stomach for administration of nutrition, fluids, and/or medications) supplies/dressings. Observed LPN 1 provide incontinence care, and care to the patient’s g-tube insertion site (mic-key button- a special low-profile tube), which was cleansed, ointment applied, and dressed with gauze. During this time, LPN 1 was queried to describe the care she provided to the patient. LPN 1 indicated she administered supplemental g-tube feedings/hydration 4 times daily, administered medications via g-tube, fed the patient a soft diet (soft in texture, minimal chewing needed, easy to swallow), provided incontinence care, showered the patient twice weekly, performed g-tube care and dressing changes, got the patient up daily for 30 minutes on the tilt table to provide leg strengthening exercise, and she cared for this patient 10 hours daily, 5 days per week. When queried if she ever needed to intermittently catheterize the patient for signs/symptoms of urinary tract infection (UTI), LPN 1 indicated she did in February (2022), which resulted in the diagnosis of UTI and treatment with antibiotics. When queried to describe the patients health condition, LPN 1 indicated the patient was involved in a severe motor vehicle accident (MVA) many years ago, which resulted in a traumatic brain injury (TBI) and seizures, and followed commands. A document received from person 3's office (patient #1's certifying physician) included a document dated 4/20/2022, titled "Office Visit". The document indicated past medical history/diagnoses included aphasia (inability to speak) due to TBI, hemiplegia (paralyzed on half of body) affecting dominant side, recurrent UTIs, incontinence of bowel and bladder, menopause, and urinary retention; allergies included clindamycin and keflex (both antibiotic medications), and keppra (anti-seizure medication). Clinical record for patient #1 was completed on 6/13/2022, start of care date 2/09/2022. A document titled “Home Health Plan of Care & Certification” for certification period 4/10/2022 – 6/08/2022, indicated the patient's equipment included oxygen, and risks for hospitalization included severe pain; and failed to include diagnoses of aphasia due to TBI, hemiplegia affecting dominant side, recurrent UTIs, incontinence of bowel and bladder, menopause, or urinary retention; allergies included clindamycin, keflex, and keppra; supplies and equipment included a pressure relieving (tilting) wheelchair with head rest and wrap around leg rests, AFOs, a tilt table, incontinence pads and adult briefs, size 14 fr (french) straight catheter kits, and g-tube size, supplies/dressings; orders included the frequency and duration of skilled nursing visits; functional limitations included contractures to both hands and bilateral foot drop; activities permitted included exercises prescribed - tilt table 30 minutes each visit for muscle strengthening/weight bearing; nutritional requirements included a soft diet, or specific orders for amount/frequency of supplemental nutritional/hydration feedings via g-tube; all orders for the skilled nurse, including administration of medications either orally or via g-tube, feed patient a soft diet, administer supplemental g-tube feedings/hydration, provide personal care, intermittent catheterization for signs/symptoms of UTI, perform leg strengthening exercises with use of a tilt table for 30 minutes daily, care for/treatment of g-tube insertion site, or application of AFOs; or any patient/caregiver education/training; patient specific interventions related to seizure activity, nutritional status, tolerance of oral feeding, prevention of UTIs, skin integrity due to immobility and incontinence, interventions to mitigate hospitalization due to severe pain or g-tube dislodgement; or amount, route, or frequency of oxygen use. During an interview on 6/13/2022 at 12:49 PM, when queried if there were skilled nursing interventions for safety measures on the plan of care, the clinical manager stated, "No." When queried if the patient used oxygen (O2), the clinical manager indicated the patient had O2 in the home, but she didn't use it continuously. When asked how much O2, and how often it was used, the clinical manager indicated she didn't know. When queried if specific O2 information should be included on the plan of care, the clinical manager stated, "Yes." When queried to describe the patient's nutritional requirements, the clinical manager indicated she received nutrition via g-tube, and when queried if she received any other means of nutrition (oral consumption), the clinical manager stated, "No." When queried if she would expect to see patient specific nutritional requirements on the plan of care, the clinical manager stated "Yes." When queried where the patient’s discharge plans were located on the on the plan of care, the clinical manager stated, "It depends ... It has to be something the [physician] would order ...." When queried if there were interventions to mitigate hospital risk, the clinical manager stated, "We would talk to the [physician] and he would write orders." When queried if there were skilled nursing interventions to address the patient's history of frequent UTIs, G tube insertion site infections, and urinary retention, the clinical manager indicated there weren't any. During an interview on 6/13/2022 at 2:05 PM, when queried if the patient was menopausal, the clinical manager stated, "She’s not that old." When queried the size of the g-tube, the clinical manager indicated she wasn't sure. When queried if the size of the g-tube should be on the plan of care, the clinical manager stated, "Yes." When queried if the plan of care included emergency precautions for dislodgement of the g-tube, the clinical manager stated, "She has to go to the hospital to get it put back in ... Yes, it should be on the plan of care." 410 IAC 17-13-1(a)(1)(B) 410 IAC 17-13-1(a)(1)(C ) 410 IAC 17-13-1(a)(1)(D)(i, ii, iii, vi, vii, viii, ix, x, xi, xiii)

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the registered nurse (RN) failed to conform with the physician's orders as noted on the plan of care for 1 of 2 records records reviewed with patients who received skilled nursing services (#4). Findings include: Clinical record review for patient #4 was completed on 6/13/2022 (start of care date 4/08/2008). The electronic medical record (EMR) evidenced the most recent plan of care was for certification period 3/26/2022 – 5/24/2022, the last skilled nursing visit was made on 1/29/2021, and the last comprehensive reassessment was completed on 1/25/2022. A document titled “Home Health Plan of Care & Certification” for certification period 3/26/2022 to 5/24/2022 indicated skilled nursing visits were ordered every 4 weeks for administration of B12 shots and lab draws for PT/INR (a blood test for therapeutic lab monitoring of a blood thinner). The EMR failed to evidence an updated order or plan of care which discontinued the order for an agency nurse to perform blood draws and administer B12 shots every 4 weeks. A home visit was conducted on 6/10/2022 at 9:25 AM with home health aide (HHA) 1. When queried if she took blood thinners, the patient indicated she did. When queried who performed blood draws for therapeutic lab monitoring, she indicated she went to the hospital for the tests monthly. When queried if she received monthly B12 shots, and who administered them, the patient indicated she did get monthly B12 shots, and her sister administered them. During an interview on 6/13/2022 at 3:57 PM, when queried who performed monthly blood draws on the patient (#4), the clinical manager indicated she used to, but now the hospital does. When queried why, the clinical manager indicated she injured her right (dominant) arm and could no longer perform the blood draws. When queried if there was another agency nurse to perform the ordered lab draws, she indicated there was not. 410 IAC 17-14-1(a)(1)(H)

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure drugs and/or treatments were administered only as ordered on the plan of care for 1 of 3 home visits observed (#1). Findings include: An undated agency policy received 6/09/2022, titled "Physician Orders/Plan of Care" stated, "... To ensure that each patient's care is under the direction of a physician ... The physician sets up a plan of care, which includes ... medications ... treatment ... diet ... an order for each service ... All orders on the [plan of care] will be specific to the patient ... and needs ...." Observation of a home visit occurred on 6/09/2022 at 1:00 PM, with patient #1 and licensed practical nurse (LPN) 1. The patient presented up in a pressure relieving (tilting) wheelchair with head rest and wrap around leg rests, contractures to both hands, and wore ankle foot orthotics (AFOs) on both feet (braces to support feet due to foot drop/inability to hold feet up). Equipment observed included a tilt table (used to facilitate weight bearing/leg muscle strengthening [a therapy modality]), incontinence pads and adult briefs, size 14 fr (french) straight catheter kits (used to obtain urine specimens for lab testing), and g-tube (a tube inserted into the stomach for administration of nutrition, fluids, and/or medications) supplies/dressings. Observed LPN 1 provide incontinence care, and care to the patient’s g-tube insertion site (mic-key button- a special low-profile tube), which was cleansed, ointment applied, and dressed with gauze. During this time, LPN 1 was queried to describe the care she provided to the patient. LPN 1 indicated she administered supplemental g-tube feedings/hydration 4 times daily, administered medications via g-tube, fed the patient a soft diet (soft in texture, minimal chewing needed, easy to swallow), provided incontinence care, showered the patient twice weekly, performed g-tube care and dressing changes, got the patient up daily for 30 minutes on the tilt table to provide leg strengthening exercise, and she cared for this patient 10 hours daily, 5 days per week. When queried if she ever needed to intermittently catheterize the patient for signs/symptoms of urinary tract infection (UTI), LPN 1 indicated she did in February (2022), which resulted in the diagnosis of UTI and treatment with antibiotics. Clinical record for patient #1 was completed on 6/13/2022, start of care date 2/09/2022. A document titled “Home Health Plan of Care & Certification” for certification period 4/10/2022 – 6/08/2022, failed to include orders for the skilled nurse to administer any medications either orally or via g-tube, feed patient a soft diet, perform leg strengthening exercises with use of a tilt table for 30 minutes daily, care for/treatment of g-tube insertion site, perform intermittent catherization for signs/symptoms of UTI, apply AFOs, or provide personal care. 17-13-1(a)

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure ongoing, interdisciplinary coordination of care for 1 of 3 home visits observed (#1). Findings include: 1. An undated agency policy received 6/13/2022, titled "Nurse Supervision" stated, "... The supervising nurse will oversee that patient communication takes place on a continuous basis ... ensure that all disciplines are aware ...." 2. An undated job description received 6/09/2022, titled "Clinical Manager/Alternate Clinical Manager" stated, "... Ensure coordination of care by all disciplines ...." 3. A job description dated 9/19/1993, titled "Home Health Care Licensed Practical Nurse [LPN] Job Description" stated, "... plans of care are discussed with ... Registered Nurse [RN] on a regular basis ...." 4. An undated job description received 6/07/2022, titled "Registered Nurse" stated, "... [Patient] assessments are communicated ...." 5. A home visit occurred on 6/08/2022 at 1:00 PM with patient #1 and licensed practical nurse (LPN) 1. When queried if the patient took foods/fluids by mouth, LPN 1 indicated she did- a soft diet (physically soft foods, making it easier to eat). Clinical record for patient #1 was completed on 6/13/2022 (start of care date 2/09/2022). A document dated and signed by LPN 1 on 2/09/2022 titled "Skilled Nursing Visit Note" indicated the patient was on a soft regular diet with supplemental g-tube (a tube inserted directly into the stomach for administration of nutrition, fluids, and/or medications) feedings. A document dated and signed by the clinical manager on 2/09/2022, titled "OASIS [outcome assessment and information set] Assessment Details" (a comprehensive assessment) indicated the patient took nothing by mouth. The clinical record failed to include interdisciplinary assessment(s) occurred, to indicate LPN 1's assessment findings were relayed to the RN, for interdisciplinary visits which occurred on the same day. During an interview on 6/13/2022 at 12:49 PM, when queried to describe the patient's nutritional requirements, the administrator/clinical manager indicated the patient received nutrition/fluids through her g-tube (a tube inserted directly into the stomach). When queried if she received food/fluids by any other method/route (oral), she stated "No." 410 IAC 17-12-2(g)

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 record review and interview, the home health agency failed to ensure it provided the name and contact information for the clinical manager to all agency patients. Findings include: On 6/09/2022 at 12:00 PM, the alternate administrator submitted the agency's admission packet/home folder for review. The admission packet/home folder failed to include the name and contact number for the clinical manager. During an interview on 6/13/2022 at 4:02 PM, the alternate administrator and administrator/clinical manager were queried where name and contact information for the clinical manager was documented in the admission packet/home folder. During this time, the clinical manager indicated all the patients had her personal cell phone number if they needed to reach her. No further information was provided.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to develop, implement, evaluate, or maintain a quality assurance/performance improvement (QAPI) program or maintained documentary evidence of its QAPI program. This practice had the potential to affect all agency patients. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.65: Quality Assessment and Performance Improvement (QAPI). Findings include: An undated agency policy received on 6/09/2022 titled "Quality Assessment & Performance Improvement Plan" indicated the agency would establish and maintain an ongoing Quality Assessment & Performance Improvement (QAPI) program. During an interview on 6/10/2022 at 11:00 AM, the surveyor requested to review the agency's QAPI program and correlating documents, to which the alternate administrator indicated there was "nothing", it was very far behind, and (they) had nothing to submit. When queried if there were any performance improvement projects (PIPs) or areas of focus, the administrator and alternate administrator indicated there were not. Upon exit, no further information was provided for review. 410 IAC 17-12-2(a)

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to maintain a coordinated agency-wide infection control program as part of the agency's quality assessment and performance improvement (QAPI) program (see tag G680); failed to provide staff with infection control education at least annually, provide staff, patients and/or caregiver(s) with COVID-19 pandemic education, and failed to provide staff with COVID-19 vaccination mandate requirements (see tag G686); and failed to ensure all staff was fully vaccinated for COVID-19, develop and implement policies and procedures to ensure that all staff were fully vaccinated for COVID-19, a process for tracking and securely documenting the COVID-19 vaccination status of all staff, or contingency plans for staff with no proof they were fully vaccinated for COVID-19 (see tag G687). This practice had the potential to affect all agency patients. Findings include: The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.70: Infection Prevention and Control.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to maintain a coordinated agency-wide infection control program as part of the agency's quality assessment and performance improvement (QAPI) program, and failed to document patient infections for 2 of 2 home visits observed with recent report of infection(s) (#1, 5). Findings include: 1. An undated agency policy received on 6/09/2022 titled "Quality Assessment & Performance Improvement Plan" indicated the agency would establish and maintain an ongoing QAPI program, which included infection control activities. 2.. An undated agency policy received on 6/07/2022 titled "Infection/Exposure Control Plan" stated, "... Purpose ... To define the mechanism that the organization will use to address surveillance, identification of infections among staff and patients ... Agency will ... measure, assess ... prevention and control of infections monthly ... Provide ... systems to track ... infections ... Require documentation of infections that are acquired while the patient is receiving services from the Agency ...." 3. A home visit was conducted on 6/08/2022 at 1:00 PM, with patient #1 and licensed practical nurse (LPN) 1. When queried if the patient experienced any recent infections, LPN 1 indicated the patient had a UTI (urinary tract infection) and was treated with antibiotics in February 2022. Observed the empty prescription bottle for cipro (an antibiotic), which was filled on 2/01/2022. Clinical record for patient #1 was completed on 6/13/2022, start of care date 2/09/2022. A document dated 2/09/2022 titled "Skilled Nursing Visit Note" indicated the patient began taking antibiotics for UTI. 4. A home visit was conducted on 6/08/2022 at 2:30 PM, with patient #5 and home health aide (HHA) 2. When queried if the patient experienced any recent hospitalizations or emergency department (ED) visits, the patient indicated she was seen in the ED on 4/16/2022 for COVID-19, and tested (+).positive. Clinical record review for patient #5 was completed on 6/13/2022 (start of care date 3/18/2017). Documents dated 4/16/2022 and 4/17/2022 titled "Aide Visit Note - Daily" failed to indicate the patient was seen in the ED or tested (+) for COVID-19. 5. On 6/07/2022 at 12:09 PM, surveyor requested (to the alternate administrator) to review the agency's Infection log. Upon survey exit, nothing was submitted. 6. During an interview on 6/10/2022 at 11:00 AM, the surveyor requested to review the agency's QAPI program and correlating documents, to which the alternate administrator indicated there was "nothing", it was very far behind, and (they) had nothing to submit. When queried if there were any performance improvement projects (PIPs) or areas of focus, the administrator and alternate administrator indicated there were not. Upon exit, no further information was provided for review.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to provide staff with infection control education at least annually; failed to provide employees, patients and/or caregiver(s) with COVID-19 pandemic education; and failed to provide employees with COVID-19 vaccination mandate requirements, for 5 of 5 employee records reviewed (Registered nurse [RN] 2, licensed practical nurse [LPN] 1, home health aide [HHA] 1, HHA 2, and HHA 3), and 3 of 3 home visits observed (#1, 4, 5). Findings include: 1. An undated agency policy received on 6/07/2022 titled "Infection/Exposure Control Plan" stated, "... Agency will ... Educate Agency personnel, patient, families/caregivers ... in the prevention and control of infections ... Infection control in services shall be scheduled no less than annually ... Attendance shall be ... documented ... Records of in service attendance shall be maintained in the personnel file ...." 2. Employee record review for HHA 1 (date of hire 8/25/2011) was completed on 6/9/2022, which failed to include documentation for any in-services. 3. Employee record review for HHA 2 (date of hire 3/13/2017) was completed on 6/9/2022, which failed to include any documented in-services. 4. Employee record review for HHA 3 (date of hire 7/31/2009) was completed on 6/9/2022, which failed to include any documented in-services. 5. Employee record review for LPN 1 (date of hire 8/16/2006) was completed on 6/09/2022, which failed to include any documented in-services. 6. Employee record review for RN 2 (date of hire 3/11/2015) was completed on 6/09/2022, which failed to include any documented in-services. 7. During an interview on 6/09/2022 at 2:44 PM, when queried where annual in-service training was documented, the alternate administrator indicated it was documented in the agency's in-service binder. No further information was provided. 8. During an interview on 6/09/2022 at 3:40 PM, when queried if there was a separate in-service binder kept, person 3 (human resource manager) stated, "Yes." No further information was provided. 9. During an interview on 6/13/2022 at 4:08 PM, the agency's in-service binder was requested for review, to which the alternate administrator stated, "We had one, but I don’t know where it is." When queried when the last in-service occurred, the alternate administrator stated, "I don't know ... a long time ...." 10. An interview was conducted with person 4 (emergency preparedness [EP] manager) on 6/13/2022 at 11:37 AM. When queried when the last time the Emergency Plan was reviewed, he indicated it was about 3 years ago, and nothing has been done since COVID-19 began. During this time, he submitted a document titled “Individual Emergency Plan” which was given to each patient. This document failed to include mitigation/education for COVID-19. When queried the last time he administered EP training with employees, he indicated it was about 3 years ago, but it wasn't documented. 11. On 6/09/2022 at 12:00 PM, the alternate administrator submitted the agency's admission packet/home folder for review, which failed to include educational information for COVID-19. 12. During an interview on 6/10/2022 at 11:10 AM, the agency's admission packet/home folder was reviewed. When queried if the agency provided patient information/education on COVID-19, person 3 (human resource manager) indicated they did not. 13. A home visit was conducted with patient #1 on 6/08/2022 at 1:00 PM. Surveyor did not observe a home folder. When queried, LPN 1 indicated there was no home folder located in the patient's home. 14. A home visit was conducted with patient #4 on 6/10/2022 at 9:25 AM. Observed the patient's home folder, which failed to include any COVID-19 information/educational documents. 15. A home visit was conducted with patient #5 on 6/08/2022 at 2:30 PM. Observed the patient's home folder, which failed to include any COVID-19 information/educational documents.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure all staff was fully vaccinated for COVID-19; failed to develop and implement policies and procedures to ensure that all staff were fully vaccinated for COVID-19 for 5 of 9 reported employees; or a process for tracking and securely documenting the COVID-19 vaccination status of all staff, or contingency plans for staff with no proof they were fully vaccinated for COVID-19. Findings include: An agency policy received on 6/09/2022, titled "2022 Coronavirus Policy", failed to indicate how the agency ensured all staff were fully vaccinated for COVID-19, a process for tracking and securely documenting the COVID-19 vaccination status of all staff, or contingency plans for staff with no proof they were fully vaccinated for COVID-19. During an interview on 06/09/2022 at 2:13 PM, when queried if the agency had any other policies/procedures for COVID-19 aside from the policy titled "2022 Coronavirus Policy", the alternate administrator stated, "... Um [sic] no ... COVID is new ... It keeps evolving." During an interview on 06/09/2022 at 2:19 PM, person 3 (human resource manager) submitted an undated, untitled document, which, per person 3, was the list of the agency's employees. registered nurse (RN) 2, licensed practical nurse (LPN) 1, home health aide (HHA) 1, HHA 2, and HHA 3 were included on the list, and the list indicated all 5 employees were vaccinated. The administrator/clinical manager was not included on the list. When queried for proof of vaccination, person 3 indicated RN 2 and LPN 1 “misplaced” their vaccination cards, and he was still waiting for them to submit their cards. At 2:31 PM, when queried about the administrator/clinical manager's proof of vaccination, person 3 indicated he thought her vaccine card "was at home". Surveyor observed submitted copies of vaccination cards for LPN 2 (not on the list), person 3, HHA 1, and HHA 3. Upon survey exit, no proof of vaccination was submitted for the administrator/clinical manager, the alternate administrator, HHA 2, RN 2, or LPN 1. Of 9 total known employees, the agency demonstrated 44% compliance with the COVID-19 vaccine mandate.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure the registered nurse (RN) and/or licensed practical nurse (LPN) completed clinical documents to include assessment findings, and/or medications/treatments administered, for 1 of 1 home visits with skilled nursing services (#1). Findings include: An undated agency job description titled "... [LPN] Job Description" stated, "... clinical records are documented ... Procedures and treatments are implemented accurately and documented appropriately ...." An undated agency job description titled "Registered Nurse" stated, "... Nursing assessment forms are completed ... [patient] conditions are assessed in every home visit ... documentation is done ...." An undated agency policy titled "Medication Administration Record (MAR" stated, "... It is required that the agency provide a medication administration record (MAR) for each patient that receive [sic] medications administered directly by a licensed nurse ... All nursing staff is required to document ... dose ... route ...." An undated agency policy titled "Physician Orders/Plan of Care" stated, "... Copies of the plan of care and other orders requiring a physician's signature should be filed in the patient record ...." An undated agency policy titled "Timeliness and Accuracy of Entries in the Clinical Record" stated, "... Each entry ... must be current, accurate ,,, must include all services ... Complete ... on the date service is rendered ...." A home visit occurred on 6/08/2022 at 1:00 PM with patient #1 and LPN 1. When queried how long she was assigned to this patient, LPN 1 indicated she has cared for this patient for 17 years (at this agency). When queried to describe her duties, LPN 1 indicated she administered medications throughout the day, fed the patient meals prepared by family (Orally and supplements via g-tube) (a tube inserted directly into the stomach for administration of nutrition, fluids, and/or medications), provided incontinence care as needed, showered the patient twice weekly, and cared for the patient's g-tube, which included cleansing, application of an ointment, and a gauze dressing. Observed LPN 1 provide incontinence care, and cleanse/dress the g-tube site. During this time, LPN indicated she saw the patient 5 days per week, from 8:00 AM - 6:00 PM. Observed a schedule posted on the inside of the patient's cabinet, which included times for medication administration, oral/g-tube feedings, and supplemental g-tube fluids, to which the LPN indicated she performed during her visits. Clinical record for patient #1 was completed on 6/13/2022, start of care date 2/09/2022. An agency document dated and signed by LPN 1 on 6/8/2022 titled "Skilled Nursing Visit Note" failed to include documentation of any medications, food, fluids, or treatments administered by LPN 1, or assessment of the g-tube insertion site. During an interview on 6/13/2022 at 1:51 PM, when queried where nurses documented medications/fluids/nutrition they administered to patients, the alternate administrator indicated it would be in their visit notes. When queried if they would expect to see medications administered by the nurse in the visit notes, the administrator/clinical manager and alternate clinical manager both stated "Yes." A comprehensive assessment document dated 2/09/2022, titled “OASIS ASSESSMENT DETAILS” was completed by the agency’s administrator/clinical manager. The document indicated the patient experienced pain, and reasons for hospitalization included pain management, but failed to include a comprehensive pain assessment was completed; and failed to indicate the patient’s lung sounds, bowel sounds, last bowel movement, g-tube assessment (or presence of), diet, nutrition/hydration status, psychological/behavioral status, neurological status, mental status, functional limitations, musculoskeletal status, fall risk assessment, activities permitted, or equipment/supply needs were assessed/documented by the RN. During an interview on 6/13/2022 at 12:49 PM, when queried to describe the patient’s nutritional requirements, the administrator/clinical manager stated, “Through her tube [g-tube].” When queried if the patient received any other route (oral) of nutrition, the clinical manager stated “No.” When queried to describe what she did during the comprehensive visit on 2/09/2022, the clinical manager stated, “I do the OASIS part, check her meds, or anything that was different, then we generate the POC [plan of care].” When queried if the comprehensive document should be fully completed by the RN, the clinical manager stated “Yes.” When queried why she didn’t assess vital signs, the clinical manager indicated the LPN (LPN 1) was there too, so she “put it down”. When queried why a comprehensive pain assessment wasn’t completed (history of hospitalization for pain management and pain was identified during the assessment), the clinical manager indicated the patient hasn’t been in the hospital for pain management, and when queried, she indicated the comprehensive assessment document may be incorrect. When queried why she didn’t assess lung sounds, she stated, “I’m not sure.” When queried why she didn’t assess the patient’s last bowel movement, she stated, “I don’t know”. When queried why she didn’t assess the patient’s musculoskeletal status, she stated “Because she can’t walk.” When queried if equipment/supplies should be assessed during the comprehensive assessment, she stated, “Yes.” 17-14-1(a)(1)(E) 17-14-1(a)(2)(B)

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 observation, record review, and interview, the home health agency failed to ensure nursing services were provided under the supervision of a registered nurse (RN) for 1 of 1 home visits observed with a licensed practical nurse (LPN) (#1). Findings include: An undated agency policy received 6/13/2022, titled "Nurse Supervision" stated, "... LPNs will be supervised at least every 30 days by a [sic] RN in the patient's home with or without the LPN present ...." A home visit was conducted on 6/08/2022 at 1:00 PM with patient #1 and LPN 1. When queried, LPN 1 indicated she provided nursing visits 10 hours per day, 5 days per week. Clinical record for patient #1 was completed on 6/13/2022, with start of care date 2/09/2022. The electronic medical record (EMR) evidenced a tab titled "Supervisory Visit Note", which failed to evidence any LPN supervisory visits were made since 8/08/2019 (prior to this admission). During an interview on 6/06/2022 at 11:02 AM, when queried where LPN supervisory visits were documented in the EMR, the administrator/clinical manager indicated they were in a separate tab in the EMR ("Supervisory Visit Note"). During an interview on 6/13/2022 at 1:51 PM, when queried the last time this patient was seen by an RN, the administrator/clinical manager stated, "... Well it was me ... [directed question to alternate administrator] didn’t they leave and go back to Mexico? ...." When queried when the last LPN supervisory visit occurred, the alternate administrator indicated the problem was she (administrator/clinical manager) wasn't listing it as a supervisory visit. No further information was provided. 17-14-1(a)(1)(J)

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the registered nurse (RN) provided a current, written HHA plan of care/aide care plan (see tag G798); failed to ensure the HHA provided services only as ordered by the physician (see tag G800); failed to ensure the RN made a supervisory visit (either by phone or on-site) at least every 60 days (see tag G814). This practice affected all agency patients who received only home health aide services. Findings include: The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.80: Home Health Aide Services. 410 IAC 17-13-2(a)

Documentation of inservice training CFR(s): 484.80(d)(2) The HHA must maintain documentation that demonstrates the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure it maintained documentation that demonstrated home health aides (HHAs) received at least 12 hours of in-service training during each 12-month period. Findings include: 1. An undated agency policy titled “Certified Nurse Aide/Home Health Aide” stated, “... Clinical Manager ... responsible for ... overseeing the home health aide visits ...... [HHA must] ... complete 12 hours of annual in-services ... [agency] must maintain documentation that demonstrates the requirements of this standard have been met” 2. Employee record for HHA 1 was completed on 6/09/2022 at 3:20 PM. The record failed to include documentation of any in-services. 3. Employee record for HHA 2 was completed on 6/09/2022 at 3:35 PM. The record failed to include documentation of any in-services. 4. Employee record for HHA 3 was completed on 6/09/2022 at 3:04 PM. The record failed to include documentation of any in-services. 5. During an interview on 6/09/2022 at 3:40 PM, informed person 3 (human resource manager) the employee records for HHAs 1, 2, and 3 failed to include any documentation of in-services attended. When queried if there was a separate in-service book, person 3 indicated there was. Nothing further was submitted. 6. During an interview on 6/13/2022 at 4:08 PM, when queried if the surveyor could review the in-service book, the alternate administrator stated, “We had one ... but I don’t know where it is ....” When queried when the last in-service occurred, the alternate administrator stated, “I don’t know ... a long time ....” Nothing further was submitted. 17-14-1(k)

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the registered nurse (RN) provided a current, written home health aide (HHA) plan of care/aide care plan for 5 of 5 patients who received HHA services (#2, 3, 4, 5, 6). Findings include: 1. An undated agency policy received 6/13/2022, titled “Certified Nurse Aide/Home Health Aide” stated, “... Clinical Manager ... responsible for ... overseeing the home health aide visits ...... Provide only those services written in the plan of care and received as written instructions from the registered nurse supervisor ... [agency] must maintain documentation that demonstrates the requirements of this standard have been met ....” 2. Clinical record review for patient #2 was completed on 6/13/2022 (start of care date 2/23/2013). The electronic medical record (EMR) included the most recent aide care plan, dated 10/28/2019. During an interview on 6/13/2022 at 3:25 PM, when queried why the aide care plan wasn’t reviewed/updated since 10/28/2019, the alternate administrator questioned the surveyor if anything newer was in the EMR, to which the surveyor stated, “No.” When queried how often the agency was supposed to review/update the aide plan of care, the alternate administrator indicated it should be reviewed/updated when they did the OASIS (outcome assessment and information set), or every 56-60 days. When queried if they recalled the last time the aide care plan was reviewed, both the alternate administrator and clinical manager indicated they were not sure. When queried the last time she saw this patient (#2), the clinical manager stated, “I’m not sure.” 3. Clinical record review for patient #3 was completed on 6/13/2022 (start of care date 4/22/2013). The EMR included the most recent aide care plan, dated 7/20/2019. During an interview on 6/13/2022 at 3:43 PM, when queried if the most recent aide care plan was dated 7/20/2019, the clinical manager stated, “Yes.” When queried if she remembered the last time she saw patient #3, the clinical manager stated, “No.” 4. Clinical record review for patient #4 was completed on 6/13/2022 (start of care date 4/08/2008). The EMR included the most recent aide care plan, dated 8/09/2019. During an interview on 6/13/2022 at 3:57 PM, when queried if there was an update aide plan of care after 8/09/2019, the alternate administrator indicated there was not. 5. Clinical record review for patient #5 was completed on 6/13/2022 (start of care date 3/18/2017). The EMR included the most recent aide care plan, dated 9/04/2019. During an interview on 6/13/2022 at 3:55 PM, when queried if there was an update aide plan of care after 9/04/2019, the alternate administrator indicated there was not. 6. Clinical record review for patient #6 was completed on 6/13/2022 (start of care date 12/08/2016). The EMR included the most recent aide care plan, dated 7/26/2019. During an interview on 6/13/2022 at 3:47 PM, when queried if there was an update aide plan of care after 7/26/2019, the alternate administrator indicated there was not. 17-13-2(a)

Non-skilled direct observation every 60 days CFR(s): 484.80(h)(2) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, the registered nurse must make an on-site visit to the location where the patient is receiving care no less frequently than every 60 days in order to observe and assess each aide while he or she is performing care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the registered nurse (RN) made a supervisory visit (either by phone or on-site) at least every 60 days for 5 of 5 clinical records reviewed with patients who received only home health aide (HHA) services (#2, 3, 4, 5, 6). Findings include: 1. An undated agency policy titled “Nurse Supervision” stated, “... If home health aide services are provided to a patient who is not receiving skilled nursing care ... the registered nurse shall make a supervisory visit to the patient’s residence ... at least every 60 days ....” 2. Clinical record review for patient #2, a HHA only patient, was completed on 6/13/2022 (start of care date 2/23/2013). An electronic medical record (EMR) document titled “Home Health Plan of Care & Certification” for certification period 7/16/2020 to 9/13/2020 indicated the patient received HHA services 3 times per week for 1-24 hours each visit, to help with personal care, and skilled nursing to evaluate HHA supervision every 30 days. The EMR also evidenced the most recent aide supervisory visit was conducted 7/14/2019. During an interview on 6/13/2022 at 3:25 PM, When queried if an aide supervisory visit occurred after 7/14/2019, the alternate administrator stated “No.” When queried when the last time an RN saw this patient (#2), the clinical manager stated, “I’m not sure.” 3. Clinical record review for patient #3, a HHA only patient, was completed on 6/13/2022 (start of care date 4/22/2013). An EMR document titled “Home Health Plan of Care & Certification” for certification period 3/16/2020 to 5/14/2020 indicated the patient received HHA services 3 times per week for 1-24 hours each visit, and skilled nursing to assess and evaluate HHA performance (no frequency). The EMR also evidenced the most recent aide supervisory visit was conducted 7/20/2019. During an interview on 6/13/2022 at 3:43 PM, when queried when queried if she remembered the last time she saw this patient (#3), the clinical manager stated, “No.” 4. Clinical record review for patient #4, a HHA only patient, was completed on 6/13/2022 (start of care date 4/08/2008). An EMR document titled “Home Health Plan of Care & Certification” for certification period 3/26/2022 to 5/24/2022 indicated the patient received HHA services 8 hours per day (not specified how many days per week). The EMR also evidenced the most recent aide supervisory visit was conducted 9/02/2019. During an interview on 6/13/2022 at 3:57 PM, when queried when she last saw the patient, the clinical manager stated, “Maybe a month ... 2 months ....”, and the alternate administrator indicated the patient was only seen by a HHA now. When queried if there were any aide supervisory visits after 9/02/2019, the alternate administrator stated, “No.” 5. Clinical record review for patient #5, a HHA only patient, was completed on 6/13/2022 (start of care date 3/18/2017). An EMR document titled “Home Health Plan of Care & Certification” for certification period 2/20/2022 to 4/20/2022 indicated the patient received HHA services 6 hours per day, 7 days per week); and skilled nursing every 30 days (not further specified), and every 56-60 days (not further specified). The EMR also evidenced the most recent aide supervisory visit was conducted 9/01/2019. During an interview on 6/13/2022 at 3:55 PM, when queried when she last saw the patient, the clinical manager stated, “I can’t remember.” When queried if an RN completed an aide supervisory visit after 9/01/2019, the alternate administrator stated, “No.” 6. Clinical record review for patient #6, a HHA only patient, was completed on 6/13/2022 (start of care date 12/08/2016). An EMR document titled “Home Health Plan of Care & Certification” for certification period 3/17/2021 to 5/15/2021 indicated the patient received HHA services 6 hours per day, 5 days per week); and skilled nursing every 30 days (not further specified), and every 56-60 days to assess and evaluate. The EMR also evidenced the most recent aide supervisory visit was conducted 6/20/2019. During an interview on 6/13/2022 at 3:47 PM, when queried when she last saw the patient, the clinical manager stated, “I don’t remember.” When queried if an aide supervisory visit was conducted after 6/20/2019, the alternate administrator stated, “No.”

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 record review and interview, the agency's governing body failed to provide responsibility of the agency's overall management and operation, including the development/maintenance of operational policies/procedures, the emergency preparedness program, and its quality assessment and performance improvement (QAPI) program (see tag G942); the agency's administrator failed to be responsible for the day-to day operations of the agency (see tag G948); failed to ensure the clinical manager was available during all operating hours (see tag G950); and the clinical manager failed to provide direct oversight/assignment of staff and patient schedules (see tag G960). This practice affected all agency patients. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.105: Organization and Administration of Services

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the agency's governing body failed to provide responsibility of the agency's overall management and operation, including the development/maintenance of operational policies/procedures, the emergency preparedness program, and its quality assessment and performance improvement (QAPI) program. Findings include: An undated agency policy received 6/07/2022, titled "Administrative Control" indicated the governing body was responsible for the agency's overall management and operation, the QAPI program, the review and approval of new policies/procedures at least annually, and governing body meetings must be held at least monthly. During an interview on 6/6/2022 at 11:02 AM, when queried who the members of the governing body were, the alternate administrator indicated he and the administrator/clinical manager were the members of the governing body. During an interview on 6/10/2022 at 11:00 AM, when queried to submit the agency’s QAPI program and governing body meeting minutes for review, the alternate administrator indicated there was nothing to submit, and it was very far behind. Upon survey exit, no further information was provided or submitted for review. During an interview on 6/13/2022 at 11:37 AM, when queried when the last time the emergency preparedness program/plan was reviewed, person 4 (emergency preparedness manager) indicated it was about 3 years ago, nothing has been done at all since COVID-19 started, and the agency didn't have anything (implemented) for COVID-19. The alternate administrator, a member of the governing body, was present during this interview. 410 IAC 17-12-1(b)

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 record review and interview, the agency's administrator failed to be responsible for the day-to day operations of the agency. Findings include: An undated agency policy received 6/07/2022, titled “Administrative Control” stated, “... alternate [administrator] ... to act in the absence of the Administrator ... At a minimum, the Administrator ... must ... Manage the daily operations of the agency ....” The administrator failed to ensure the day-to-day operations of the home health agency as evidenced by: The administrator failed to ensure there was a current Emergency Preparedness Program in place for the home health agency. Please see tag E-0001, Condition of Participation 42CFR §484.102: Emergency Preparedness, and the additional tags associated with this federal regulation. The administrator failed to ensure each patient received, or the agency provided, comprehensive assessment(s)/reassessment(s). Please see tag G510, Condition of Participation 42CFR §484.55: Comprehensive Assessment of Patients, and the additional tags associated with this federal regulation. The administrator failed to ensure the agency developed and implemented an effective discharge planning process in accordance with the Condition of Participation 42CFR §484.58: Discharge Planning. Please see tag G560, and the additional tags associated with this federal regulation. The administrator failed to ensure each patient received an individualized written plan of care, which included any revisions or additions. Please see tag G570, Condition of Participation 42CFR §484.60: Care Planning, Coordination of Services, and Quality of Care, and the additional tags associated with this federal regulation. The administrator failed to ensure the agency developed, implemented, evaluated, or maintained an effective, ongoing, agency-wide, data-driven quality assessment and performance improvement QAPI program. Please see tag G640, Condition of Participation 42CFR §484.65: Quality Assessment and Performance Improvement (QAPI). The administrator failed to ensure the agency maintained and documented an infection control program, which also included compliance with the COVID-19 vaccine mandate requirement. Please see tag G680, Condition of Participation 42CFR §484.70: Infection Prevention and Control, and the additional tags associated with this federal regulation. The administrator failed to ensure home health aide (HHA) services were provided in accordance with the Condition of Participation 42CFR §484.80: Home Health Aide Services. Please see tag G750, and the additional tags associated with this federal regulation. The administrator failed to ensure the clinical manager was available during all operating hours (please see tag G950). The administrator failed to ensure her availability during all operating hours (please see tag G956). The administrator failed to ensure the clinical manager provided oversight of all patient care services and personnel (please see tag G958). The administrator failed to ensure the clinical manager provided direct oversight/assignment of staff and patient schedules (please see tag G960). The administrator failed to ensure the clinical manager ensured patient needs were continually assessed (please see tag G966). The administrator failed to ensure the clinical manager developed, implemented, and updated the individualized plans of care (please see tag G968). The administrator failed to ensure the agency maintained patient clinical records in accordance with the Condition of Participation 42CFR §484.110: Clinical Records. Please see tag G1008, and the additional tags associated with this federal regulation. 410 IAC 17-12-1(b)(3) 410 IAC 17-12-1(c)(1)

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the clinical manager was available during all operating hours. Findings include: An undated agency policy titled "Administrative Control" indicated the administrator or alternate, and the clinical manager or alternate would be available during the agency's operating hours, either in person or by telephone. On Tuesday, 5/31/2022, the surveyor arrived to the agency at 10:30 AM. The door was locked, and no one answered to several knocks. The interior was visible from the glass door, and no lights were on. There was a sign posted on the window, which stated "... If you need immediate assistance call (219) 762-0004 ...." On 5/31/2022 the surveyor called (219) 762-0004 at 10:34 AM, 10:35 AM, and 10:36 AM. The calls went directly to a recorded message, which failed to indicate the number called was Healthmasters, Inc., indicated the voicemail box was full, and there was no option to leave a message for a return call. On 5/31/2022 at 11:20 AM, the surveyor emailed the administrator at "rozzilov@gmail.com", in attempt to make contact. No return email was received. On 5/31/2022 at 12:17 PM, the surveyor returned to the agency, to find no one there. On 5/31/2022 at 2:23 PM, the surveyor called (219) 762-0004. Again, the calls went directly to a recorded message, which failed to indicate the number called was Healthmasters, Inc., indicated the voicemail box was full, and there was no option to leave a message for a return call. On 6/01/2022 at 2:27 PM, the surveyor received a call from (219) 742-3444. The callers identified themselves (administrator/clinical manager) and alternate administrator) They indicated they were closed for the "holiday" on Monday, 5/30/2022 and Tuesday, 5/31/2022. On Wednesday, 6/08/2022 at 2:17 PM, the surveyor called the agency. The call went directly to a recorded message, which failed to indicate the number called was Healthmasters, Inc., indicated the voicemail box was full, and there was no option to leave a message for a return call. On Friday, 6/10/2022 at 9:35 AM, the surveyor called the agency 3 times in a row. The calls went directly to a recorded message, which stated "We're sorry, you have reached a number that has been disconnected or is no longer in service." On 6/10/2022 at 9:30 AM, informed the administrator/clinical manager, the alternate administrator, and person 3 (human resource manager) of the phone messages that it was disconnected, to which the alternate administrator indicated the phone carrier was going to get them "shut down". 410 IAC 17-12-1(d)

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide direct oversight/assignment of staff and patient schedules. Findings include: An undated agency policy titled "Administrative Control" stated "... The Clinical Manager shall ... Making patient and personnel assignments ...." On 6/06/2022 at 11:55 AM, surveyor requested a list of all patients scheduled for home visits during the survey, to include date/time of visit, staff name with discipline assigned, and location of patient (city). On 6/09/2022, the alternate administrator submitted an undated document titled "Patient Schedule" for patients #2, 3, 4, 5, and 6, but failed to include patient #1 and 7's scheduled visits. During an interview on 6/07/2022 at 11:57 AM, when queried about patient #7's current disposition, the clinical manager indicated patient #7 was currently discharged, and was in Mexico with family. During an interview on 6/13/2022 at 4:00 PM, when queried about patient #7's current disposition, the clinical manager indicated patient #7 was readmitted about a week and a half ago (on or about 6/01/2022). When queried who readmitted him, the clinical manager indicated RN 2 did. Patient #7's clinical record indicated he was readmitted on 5/20/2022. During an interview on 6/13/2022 at 1:51 PM, when queried the last time patient #1 was seen by an RN, the clinical manager stated. "Well it was me ... didn’t they leave and go back to Mexico [query directed to alternate administrator]?" The alternate administrator indicated the last RN visit would have been in April (2022). 410 IAC 17-14-1(a)(1)(K)

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 record review and interview, the home health agency failed to ensure the patient's clinical record contained a current comprehensive assessment, all of the assessments from the most recent home health admission, or plans of care that were signed by the certifying physician (see tag G1012); failed to ensure the patient's clinical record was updated to include the physician's contact information (see tag G1020); failed to ensure all clinical documents were current, accurate, complete, dated, and timed (see tag G1024); and failed to ensure all patients’ clinical records were safeguarded against loss or unauthorized use (see tag G1028). Findings include: The cumulative effect of these systemic problems resulted in the home health agency being found out of compliance for the Condition of Participation 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 home health agency failed to ensure the patient's clinical record contained a current comprehensive assessment, all of the assessments from the most recent home health admission, or plans of care that were signed by the certifying physician, for 7 of 7 records reviewed (#1, 2, 3, 4, 5, 6, 7). Findings include: 1. An undated agency policy titled "Physician Orders/Plan of Care" stated "... Copies of the plan of care and other orders requiring a physician's signature should be filed in the patient's record within 3 days of receipt ...." 2. An undated agency policy titled "Timeliness and Accuracy of Entries in the Clinical Record" stated, "... Each entry into the patient's record must be ... signed ... Signed physician orders will be filed in the clinical record within 48 hours ...." 3. An undated agency policy titled “Comprehensive Assessment of Patients (OASIS) [outcome assessment and information set]” stated “... A comprehensive assessment ... will be performed ... not less frequently than every second month ...." 4. During an interview on 6/06/2022 at 11:02 AM, when queried how the agency maintained clinical records, the administrator and alternate administrator both indicated there were no paper charts or clinical documents, and everything was located in the electronic medical record (EMR). 5.Clinical record for patient #1 was completed on 6/13/2022, (start of care date 2/09/2022), for certification period 4/10/2022 – 6/08/2022. The EMR failed to include a comprehensive reassessment or plan of care for the certification period that began on 6/09/2022, and failed to include plans of care with the physician's signature, for certification periods 2/09/2022 - 4/09/2022, and 4/10/2022 - 6/08/2022. During an interview on 6/06/2022 at 1:57 PM, when queried where the current plan of care with the physician’s signature (for patient #1) was located in the EMR, the administrator and alternate administrator both indicated it was a paper copy, and not in the EMR. When queried on the location of the paper copy, the administrator indicated she thought she could find it. When queried if the paper copy was located on the premises, the administrator indicated she’d look, and walked to the back of the office. During this time, the alternate administrator indicated if the document was not on the premises, he could get it. When queried where the document would be if not on the premises, the alternate administrator stated, “We have them [clinical documents] at home as well.” 6. Clinical record review for patient #2 was completed on 6/13/2022 (start of care date 2/23/2013). The EMR evidenced comprehensive re-assessment was completed on 11/20/2020, and the most recent completed plan of care was for certification period 1/18/2020 – 3/17/2020, which was not signed by the physician. During an interview on 6/13/2022 at 3:25 PM, when queried when the last time an RN saw this patient (#2), the clinical manager stated, “I’m not sure.” When queried if an RN completed a comprehensive re-assessment after 11/20/2020, the alternate administrator stated, “... No, I don’t see any ... No, there’s none.” During an interview on 6/13/2022 at 3:25 PM, when queried if the EMR included a completed plan of care any time after 3/17/2020, the alternate administrator indicated there was not. 7. Clinical record review for patient #3 was completed on 6/13/2022 (start of care date 4/22/2013). The EMR evidenced the last comprehensive re-assessment was completed 7/11/2020, the most recent plan of care was for certification period 3/16/2020 – 5/14/2020, which was not signed by the physician. During an interview on 6/13/2022 at 3:43 PM, during EMR review, when queried if she remembered the last time she saw this patient (#3), the clinical manager stated, “No.” When queried if any comprehensive re-assessments were completed after 7/11/2020, the alternate administrator stated, “No.” During an interview on 6/13/2022 at 3:43 PM, when queried if the EMR included a completed plan of care any time after 5/14/2020, the alternate administrator indicated there was not. 8. Clinical record review for patient #4 was completed on 6/13/2022 (start of care date 4/08/2008). The EMR evidenced the last comprehensive re-assessment was completed 1/25/2022, and the last routine skilled nursing visit was 1/29/2021, and the most recent plan of care was for certification period 3/26/2022 – 5/24/2022, which was not signed by the physician. During an interview on 6/13/2022 at 3:57 PM, when queried when she last saw the patient, the clinical manager stated, “Maybe a month ... 2 months ....” When queried if a comprehensive re-assessment was completed after 1/25/2022, the alternate administrator stated, “No ....” During an interview on 6/13/2022 at 3:57 PM, when queried if the EMR included a completed plan of care any time after 5/22/2022, the alternate administrator indicated there was not. 9. Clinical record review for patient #5 was completed on 6/13/2022 (start of care date 3/18/2017). The EMR evidenced the last comprehensive re-assessment was completed 2/20/2022, and the most recent plan of care was for certification period 2/20/2022 – 4/20/2022, which was not signed by the physician. During an interview on 6/13/2022 at 3:53 PM, when queried when she last saw the patient, the clinical manager stated, “I can’t remember.” When queried if an RN completed a comprehensive re-assessment after 2/20/2022, the alternate administrator stated, “No.” During an interview on 6/13/2022 at 3:50 PM, when queried if the EMR included a completed plan of care any time after 4/20/2022, the alternate administrator indicated there was not. 10. Clinical record review for patient #6 was completed on 6/13/2022 (start of care date 12/08/2016). The EMR evidenced the last comprehensive re-assessment was completed 7/15/2021, and the most recent plan of care was for certification period 3/17/2021 – 5/15/2021, which was not signed by the physician. During an interview on 6/13/2022 at 3:47 PM, when queried when she last saw the patient, the clinical manager stated, “I don’t remember.” When queried if an RN completed a comprehensive re-assessment after 7/15/2021, the alternate administrator stated, “No.” During an interview on 06/09/2022 at 12:40 PM, when queried why the patient had no plan of care after 5/2021, the alternate administrator indicated the patient didn’t, and they would have to generate one for her as well. 11. Clinical record review for patient #7 was completed on 6/13/2022 (start of care date 5/20/2022). The EMR evidenced the most recent plan of care was for certification period 11/05/2021 to 1/03/2022, which indicated a start of care date of 5/20/2022, and did not include a plan of care for the re-admission on 5/20/2022, for certification period 5/20/2022 - 7/18/2022. During an interview on 6/13/2022 at 4:00 PM, when queried if the EMR included a plan of care for this admission (5/20/2022), the alternate administrator indicated there was not. 410 IAC 17-15-1(a)(1) - (7)

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all patients’ clinical records were safeguarded against loss or unauthorized use. Findings include: An undated agency policy titled “Patient’s Bill of Rights” stated, “... The patient has the right to confidentiality of clinical records maintained by the ... agency ....” During an interview on 6/06/2022 at 11:02 AM, when queried how the agency maintained clinical records, the administrator and alternate administrator both indicated there were no paper charts or clinical documents, and everything was located in the electronic medical record (EMR). During an interview on 6/06/2022 at 1:57 PM, when queried where the current plan of care with the physician’s signature (for patient #1) was located in the EMR, the administrator and alternate administrator both indicated it was a paper copy, and not in the EMR. When queried on the location of the paper copy, the administrator indicated she thought she could find it. When queried if the paper copy was located on the premises, the administrator indicated she’d look, and walked to the back of the office. During this time, the alternate administrator indicated if the document was not on the premises, he could get it. When queried where the document would be if not on the premises, the alternate administrator stated, “We have them [clinical documents] at home as well.” During this time, the surveyor and alternate administrator walked to the back of the office. Two large (30 gallon) black plastic garbage bags and 1 white (13 gallon) garbage bag was observed on a table and the floor in an open area. The bags contained hundreds of clinical and billing documents for the agency’s patients, which were not in separate, patient specific records. Additional records were observed on an open bookshelf. Unsecured documents located included those for patients #1, 2, 3, 4, 5, 6, and 7. During an interview on 6/13/2022 at 4:00 PM, the surveyor requested a copy of patient #7’s 2021 discharge summary, and admission order for the 5/22/2022 re-admission, as they were not included in the EMR. The alternate administrator indicated he had them, they were on a disk at home, and he wished he brought it. 17-15-1(c)