Every finding on record at Amedisys Missouri, LLC

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 04/10/2024. During the survey it was determined the home health provider is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Providers.

A partial extended survey for Medicare recertification for the home health provider was completed on 04/10/2024. The provider had 187 current patients.

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 policy review, record review, observation and interview, the home health provider failed to ensure staff maintain an accurate and updated medication profile in, but not limited to, two of three home visit observations (Records/Patients #2 and #3). This deficient practice has the potential to affect all patients served by the provider. RECORD/PATIENT #3: Review of the clinical record showed the patient admitted to home health services on 01/05/2024 with a primary diagnosis of non-pressure chronic ulcer of the right foot. The patient lived at home with his/her spouse. Review of the document titled, "Medication List," dated 04/09/2024, showed the patient was taking the following medications: -Acetaminophen 325 mg tablet, take two tablets two times daily; -Biotin (a B vitamin) 1 mg tablet, take one tablet daily, the patient was not taking this medication; -Citalopram (used to treat depression, including major depressive disorder) 20 mg tablet, take one tablet daily, the patient was not taking this medication; -Ferrous Sulfate 325 mg (65 mg iron) tablet, take one tablet daily; -Lactobacillus Acidophilus (used for diarrhea from antibiotics) one billion cell tablet, take one tablet two times daily, the patient was not taking this medication; -Levothyroxine (used to treat an underactive thyroid gland) 25 micrograms (mcg) tablet, take one tablet daily; -Macrodantin (used to treat infections of the urinary system caused by bacteria) 100 mg capsule, take one capsule daily, the patient was not taking this medication; -Pantoprazole (reduces the amount of acid your stomach makes) 40 mg tablet, take one tablet daily, the patient was not taking this medication; -Prednisone (used to treat many diseases and conditions, especially those associated with inflammation) 20 mg tablet, take one tablet as directed, the patient was not taking this medication; and -Vitamin D3 10 mcg (400 unit) capsules, take one capsule daily. Observation on 04/10/2024 at 2:00 PM, during the patient's home visit, showed the patient was taking the following medications: -Acetaminophen 500 mg tablet, take two tablets one time daily as needed; -Ferrous Sulfate 325 mg (28 mg iron) tablet, take one tablet daily; -Levothyroxine 50 mcg tablet, take one tablet daily; -Vitamin D3 5000 unit capsule, take one capsule daily; -Fish oil 2400 mg capsule, take one capsule two times daily, this medication was not on the provider's medication list; -Probiotic 2 billion cell capsule, take one capsule once daily, this medication was not on the provider's medication list; and -Omeprazole 20 mg capsule, take one capsule daily, this medication was not on the provider's medication list. During an interview on 04/10/2024 at 3:00 PM, the home health administrator stated that he/she would expect all medications on the medication list to match what the patient was taking. Review of the provider’s policy titled, “Drug Regimen Review,” last revision dated December 1, 2023, showed, in part: - The purpose of the policy is to identify appropriateness, inconsistencies and /or significant drug interactions as well as ensure a comprehensive list of medications are updated any time there is a medication change including dose change, new medications, and any medications discontinued. - A copy of the Medication Profile is taken to the patient’s home and placed in the patient’s home folder and incorporated in the medical record. RECORD/PATIENT #2: Review of the clinical record showed the patient admitted to home health services on 01/17/2024 with a primary diagnoses of falls and Osteoarthritis (a condition in which the body's joints break down over time).The patient lived at home alone. Observation and interview on 04/10/2024 at 9:40 AM, during the patient’s home visit, showed the following medication discrepancy, the provider’s medication profile showed an order for Cefdinir (an antibiotic used to treat infection), 300 milligrams (mg), take one capsule two times daily. The patient’s stated that he/she was no longer taking the medication, and the medication bottle was no longer in the home. Review of the patient’s active medical record showed an order dated 03/12/2024 to 03/17 /2024 for Cefdinir 300 (mg), take one capsule two times daily for five days. During an interview on 04/10/2024 at 2:30 PM, the administrator stated the medication, “should have been taken off the active medication profile”.

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 policy review, record review, and interview, the home health provider failed to ensure the plan of care was individualized to the specific needs of the patient in one of five full records reviewed (Record/Patient #1). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider's policy titled, "Physician Orders and Medical Supervision of the Plan of Care," dated 06/22/2023, showed each patient must receive an individualized written plan of care, including and revisions or additions. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 01/26/2024 with a primary diagnosis of orthopedic aftercare following surgical amputation. The patient lived at home with his/her spouse. Review of the document titled "Home Health Certification and Plan of Care," dated 03/26/2024, showed the patient was taking the following medications: -Aspirin (nonsteroidal anti-inflammatory and blood thinner) 81 milligrams (mg) chewable tablet, take one tablet daily with breakfast; and -Clopidogrel (an antiplatelet medication) 75 mg tablet, take one tablet daily in the morning. The plan of care failed to include interventions for antiplatelet medications. During an interview on 04/10/2024 at 3:00 PM, the administrator stated that he/she would expect the plan of care to include all interventions relative to the patient.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on policy review, observation, and interview, the home health provider failed to ensure an accurate and visit schedule was placed in the patient's home folder in one of three full records reviewed (Record/Patient #3). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider's policy titled, "Patient Rights and Responsibilities," dated 04/04/2023, showed, in part, the patient has the right to be informed about the disciplines that will furnish care and the frequency of visits. RECORD/PATIENT #3: Review of the clinical record showed the patient admitted to home health services on 01/05/2024 with a primary diagnosis of non-pressure chronic ulcer (caused by poor circulation, which in turn is caused by venous or arterial insufficiency) of the right foot. The patient lived at home with his/her spouse. Review of the document titled, "Home Health Certification and Plan of Care," dated 03/05/2024-05/03/2024 showed the patient was ordered skilled nurse (SN) visits as follows: - One time a week for one week; - Two times a week for two weeks; - One time a week for 6 weeks; and - Two PRN (pro re nata - as needed) visits for signs and symptoms of infection. Observation on 04/10/2024 at 2:00 PM, during the patient's home visit, showed the home folder contained a blank calendar. The home folder failed to contain the discipline visit frequency. During an interview on 04/10/2024 at 3:00 PM, the administrator stated that he/she would expect the visit schedule to be contained in the patient's home folder.

The Emergency Preparedness regulations were reviewed as part of the Medicare certification survey completed on 10/21/2021. During the survey it was determined Amedisys Home Health of Missouri (Poplar Bluff) is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Agencies.

A complaint investigation (MO00164589) was completed on 10/21/2021 at Amedisys Home Health of Missouri. The agency had 228 current patients. The complaint was not substantiated. None of the allegations were verified and no deficiencies are cited.

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on agency policy, home visit observation and interview, the agency failed to provide the patient and representative (if any) correct contact information for the current home health agency administrator, to receive complaints in one (Record/Patient #3) of the three home visits conducted. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of agency’s policy titled, “Patient Rights and Responsibilities,” dated 06/24/2021, showed the agency will provide contact information for the HHA administrator, including the administrator’s name, business address, and business phone number in order to receive complaints. RECORD/PATIENT #3: During a home visit observation on 10/19/21 at 9:15 AM, review of the admission packet left in the home failed to show the administrator’s name to receive complaints. The observation findings were reviewed with the administrator on 10/19/2021 at 1:00 PM. He/she acknowledged the findings and stated that he/she would expect the administrator’s name, business address and business phone number to be available, in writing, for the patient.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to provide a copy of the written notice regarding the patient's financial obligation in one (Record/Patient #1) of six full records reviewed . This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency policy titled, "Patient Rights and Responsibilities," revised 06/24/2021, showed the patient has the right to be advised orally and in writing the extent to which payment for HHA (home health agency) services may be expected from Medicare, Medicaid or any other federally-funded or federal aid program known to the HHA, the charges for services that may not be covered by Medicare, Medicaid or any other federally-funded or federal aid program know to the HHA, and the charges the individual may have to pay before care is initiated. RECORD/PATIENT #1: Review of the plan of care dated 09/27/2021 showed an order for skilled nursing two times a week for one week, three times a week for four weeks, once a week for four weeks and one as needed visit. Observation and interview, during the patient's home visit, on 10/19/2021 beginning at 9:15 AM showed that the patient's home folder did not contain information regarding the cost or what the patient may be required to pay for services. The patient's caregiver stated that he/she remembered seeing something like that when the patient was on home health before but had not seen anything regarding financial liability this time. During an interview on 10/19/2021 at 3:30 PM the administrator provided a copy of the consent form that included financial information signed by the patient's spouse on 09/27/2021. The administrator stated that a copy of the financial liability information should be left in the home.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on policy review, the agency's current patient rights information, and interview, the agency failed to provide proper written notice in advance of the agency reducing or terminating on-going care for two (Record/Patients #4 and #6) of six full records reviewed. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: Review of the agency's policy titled, "Home Health Change of Care Notice (HHCCN)," revised 03/25/2021, showed in part the following: -The HHCCN is issued to the traditional/Original Medicare Beneficiary before reducing or terminating most ongoing care provided by the agency. Medicare currently requires home health agencies (HHAs) to issue HHCCNs to Medicare beneficiaries receiving home health care benefits for notification of plan of care changes; -When multiple care changes occur due to simultaneous order changes and agency specific reasons, the HHA must give the beneficiary (2) separate HHCCN's so that he/she can identify the reason that corresponds with each change; -The beneficiary or representative must sign and date the HHCCN; -The HHCCN should be delivered far enough in advance of the care change so that the beneficiary may pursue alternatives to continue receiving the care noted on the HHCCN. "Far enough in advance" is defined by CMS as the beneficiary has time to make other arrangements. When plans for issuance of the notice are known in advance, the HHCCN should not be issued so far in advance as to cause confusion regarding the information it conveys. Issuing "far in advance" should be avoided whenever possible, but is permissible when a situation occurs prompting an immediate determination to reduce or end services that could not have been made in advance; and -Triggering events are reductions or terminations in care. Review of the agency's policy titled, "Medicare Notice of Non-Coverage," revised 03/25/2021, showed in part the following: -Medicare beneficiaries will receive a Notice of Medicare Non-Coverage (NOMNC) at least 2 days prior to the discontinuation of services; -At least 2 days prior to discharge or earlier, the clinician will notify the patient of the proposed date for end of service, and their right to appeal if they disagree with the discharge or termination of services. A NOMNC must be delivered even if the beneficiary agrees with the termination of services; and -The clinician will review the NOMNC with the patient and explain their right to an appeal and the process to be followed if they choose to do so. The clinician will explain who the QIO is and review with the patient the numbers for calling the QIO if they choose to appeal. Review of the agency's policy titled, "Patient Rights and Responsibilities," revised 06/24/2021, showed in part the following: -The agency recognizes, respects, and promotes the rights of each individual patient in accordance with fundamental human, civil, constitutional, and statutory rights; and -Receive proper written notice, in advance of a specific service being furnished, if the agency believes that the service may be non-covered care; or in advance of the agency reducing or terminating on-going care. The agency must also comply with the requirements of 42 CFR 405.1200 through 405.1204. RECORD/PATIENT #4: Review of the clinical record showed: -The plan of care (POC) dated 09/06/2021 through 11/04/2021 showed skilled nursing visits twice a week for three weeks, then once a week for five weeks; -A verbal order, dated 09/15/2021 showed effective 09/19/2021 skilled nursing visits one time a week for seven weeks; and -There was no HHCCN in the patient's medical record. The agency failed to provide the patient written notice in advance of reducing skilled nursing visits. During an interview on 10/20/2021 at 10:40 AM, the administrator stated that he/she would have expected an HHCCN to be provided to the patient when the agency reduced the skilled nursing visits. No further information was provided. RECORD/PATIENT #6: Review of the clinical record review showed: -The patient was discharged on 02/22/2021 due to goals being met; and -There was no NOMNC in the patient's medical record. The agency failed to provide the patient written notice in advance of discharging the patient from service. During an interview on 10/20/2021 at 10:40 AM, the administrator stated that he/she would have expected a NOMNC to be provided to the patient prior to discharge. No further information was provided.

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 policy review, record review, and interview, the agency failed to complete the initial assessment of the patient within 48 hours of the referral to home care, or 48 hours after the patient's return home, or on the physician ordered start of care date in one (Patient/Record #1) of six full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency policy titled, “Oasis Outcome and Information Set (OASIS, a federally mandated assessment),” revised 03/25/2021, showed in part, the time frame for the initial assessment visit/start of care is within 48 hours of the referral or within 48 hours of the patient’s return to home or on the physician ordered start of care date. RECORD/PATIENT #1: Review of the hospital discharge report dated and faxed to the agency on 09/24/2021 showed an order for the patient to discharge to home with home health. Review of the registered nurse (RN) OASIS admission/comprehensive assessment dated 09/27/2021 (three days after referral) showed: -The patient was discharged from an inpatient facility on 09/24/2021; -Date of physician ordered SOC 09/24/2021 and -This date was edited to show the physician ordered SOC date was 09/27/2021 and a visit note addendum was added on 10/05/2021. Review of the record showed no documentation of physician notification within 48 hours of the referral or physician order for the delay in SOC. Review of a client coordination note dated 10/01/2021 (four days after the SOC) showed delay in start of care per patient request. Physician notified and agreeable for SOC on 09/27/2021. During an interview on 10/20/2021 at 9:35 AM the administrator stated that their record is not clear regarding the physician contact for the delayed SOC. The physician should have been contacted and a note made within 48 hours of the referral.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to include documentation of pertinent information in the comprehensive assessment regarding the insertion, location, and assessment of a PICC (peripherally inserted central catheter) in one (Record/Patient #5) of six full records reviewed. This deficient practice has the potential to adversely affect the care of all the agency's patients. Findings included: Review of the agency's policy titled, "Central Venous Access Device (CVAD) Dressing Change," dated 01/2020, showed, in part, the following information. - Gauze dressings are changed every 48 hours; - Transparent dressings are changed at least every 7 days; - The clinician is to document in the clinical record: *Appearance of catheter and insertion/exit site; *Length of external segment measured; *Date and time procedure performed; *Type of dressing applied; *Patency of catheter and types/amounts of flush solutions used; *Any physician communication/care coordination/notification; and *Patient's tolerance of the procedure and any education provided to client/caregiver. RECORD/PATIENT #5: Review of the plan of care dated 09/30/2021 to 11/02/2021 showed the patient was admitted on 09/30/2021 with primary diagnosis of aftercare following a kidney transplant and ESRD (end stage renal disease-when the kidneys are no longer functioning to remove toxins from the blood). Skilled nursing was ordered two times per week to obtain lab draws. Review of the clinical record showed: - On the start of care comprehensive assessment dated 09/30/2021, documentation showed lab was drawn from the left AC (antecubital space-bend of arm) and the patient had a right side of neck subclavian line (a central venous access for infusion-the subclavian vein near the collar bone is a frequently used site) with the dressing intact; - On the 10/05/2021 skilled nurse visit note, documentation showed lab was drawn from the left AC space and failed to show status of the right subclavian line; - On the 10/07/2021 skilled nurse visit note, documentation showed "labs obtained via PICC line. Purple lumen, flushed with 10 cc (cubic centimeters) of normal saline (mild salt solution), withdrawal 10 cc of blood and disposed of, withdrawal another 10 cc of blood and transferred 2 SST (serum separator tube), one lavender and one red top…..Flushed with 5 cc of heparin (blood thinner)….Flushed red lumen with 10 cc of normal saline." The note failed to show when the PICC was inserted or an assessment of the site. The note failed to show the status of the right subclavian line; - On the 10/11/2021 skilled nurse visit note, an assessment showed the PICC line was a mid-line (non-central) catheter, no problems with site, the length of the exposed catheter was 1.0 centimeter, arm circumference was 13, the site was covered with a transparent dressing that was clean, dry, and intact, the dressing was changed 10/11/2021, both lumens flush easily and the purple lumen had good blood return. The lab was drawn through the PICC line with the same procedure as the 10/07/2021 visit. The note failed to show the status of the right subclavian line; - Then on the 10/19/2021 skilled nurse visit note, LPN A documented two PICC line type catheters. One was documented as "subclavine PICC right side 3 sutures" and "subclavine right side of neck."; and - The assessments of the central line and PICC line lacked clarity and failed to show that both lines were being cared for according to agency policy. During an interview on 10/20/2021 at 2:30 PM, the administrator stated that: - The PICC line placement should have been documented in the skilled visit notes; and - The PICC line was placed specifically for lab draws after the start of care.

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 policy review, record review, home visit observation, and interview, the agency failed to ensure a complete/accurate medication review and/or update of the patient's medications was completed in, but not limited to, three (Record #1, #2 and #3) of six full records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #3: Review of plan of care (POC) dated 09/03/21 showed patient had a primary diagnosis of type 2 diabetes mellitus with other skin ulcer (A chronic condition that affects the way the body processes blood sugar) and was admitted on 05/06/21. Other diagnoses included but not limited to: non- pressure chronic ulcer on other part of left lower leg limited to breakdown of skin (an open sore that is not healing), urinary tract infection (an infection in any part of the urinary system, the kidneys, bladder, or urethra), chronic obstructive pulmonary disease (COPD) (a group of lung diseases that block airflow and make it difficult to breathe), and chronic kidney disease (damage to the kidneys that makes them unable to filter blood properly). Review of the skilled nurse visit notes showed the skilled nurse documented that all medication containers, including current, discontinued, prescription, herbal and over the counter (OTC), were gathered from all locations in the home and no medication discrepancies were found on 09/03/21, 09/07/21, 09/10/21, 09/15/21, 09/17/21, 09/21/21, 09/24/21, 09/28/21, 10/01/21, 10/06/21, 10/08/21, 10/12/21, and 10/14/21. During an observation visit at the patient’s home visit on 10/19/21 at 10:30 AM, the medications were reconciled using a current medication profile supplied by the agency and a list left in the home by the in-home provider who fills the medication planner. All medications were in a locked box and were unavailable for examination. This reconciliation showed the following discrepancies: -Agency profile shows Atorvastatin 1 mg daily and the patient’s home medication list shows Atorvastatin 10mg daily at bedtime; -Agency profile shows Diltiazem CD 1 mg daily and the patient’s home medication list shows Diltiazem ER 240mg daily; -Agency profile shows Eliquis 1 mg 2 times daily and the patient’s home medication list shows Eliquis 5 mg 2 times daily; -Agency profile shows Furosemide 1 mg 2 times daily and the patient’s home medication list shows Furosemide 40mg every morning and noon; -Agency profile shows Gabapentin 1 mg 3 times daily and the patient’s home medication list shows Gabapentin 300mg 3 times daily; -Agency profile shows Metoprolol Tartrate 12.5 mg daily and the patient’s home medication list shows Metoprolol Tartrate 50mg tab give ½ tab 2 times daily; -Agency profile shows Potassium Chloride 1 mEq 2 times daily and the patient’s home medication list shows Potassium Chloride 20 mEq 3 times daily; -Agency profile shows Vitamin B-12 1 mcg daily and the patient’s home medication list shows Vitamin B-12 1000mcg daily; -Agency profile shows Victoza 1mg SQ injection daily and the patient’s home medication list shows Victoza 1.8mg SQ injection daily; and -Agency profile shows Novolog sliding scale insulin 3 times daily: *151-199 = 2 units; *200-299 = 4 units; *300-399 = 6 units; *over 400 = 8 units; And the patient’s home medication profile shows Humalog insulin: *6 units in the am plus sliding scale; *5 units at lunch plus sliding scale; *5 units at supper plus sliding scale. Additional medications on the patient's home list that were not on plan of care or the agency’s medication profile: -Omeprazole 20mg daily; -Women’s One-A-Day Multivitamin daily; -Estradiol Vaginal Cream 0.01% 1 gram daily; -Colace 100mg 2 times a day as needed; -Nitroglycerine 0.4mg sublingual tab as needed for chest pain; -Tylenol 500 mg 2 tablets as needed; -Acidophilus probiotic 1 tablet daily; -Cranberry Supplement 1 tablet 3 times daily; and -Metalazone 2.5mg 1 tab 2 times a week on Tuesdays and Saturdays. During the observation visit, RN D was also observed reconciling the home medication list with the agency medication profile. He/she indicated that many discrepancies were found. During an interview on 10/20/21 at 2:00 PM, the administrator stated that he/she would expect the clinician to reconcile medications on the profile and plan of care with actual home medications, including over the counter medications at every home visit. Findings included: Review of the agency policy titled, "Drug Regimen Review," revised 01/2020 showed: -The purpose is to identify appropriateness, inconsistencies, and/or significant drug interactions in the patient's current medication regimen, as well as ensure the comprehensive list of medications are updated anytime there is a medication change including dose changes, new medications, and any medications discontinued; - The clinician completing the OASIS (outcome assessment information set, a federally mandated assessment) must complete a comprehensive drug regimen review of all medications the patient is currently taking at the time of admission, recertification, resumption of care and with any major change in condition; - The medication profile is completed by documenting all the patient's medications which includes medications on written prescriptions and medication bottles, over-the-counter medications, herbal products, vitamins, supplements and oxygen; - The clinician will question the patient and/or caregiver periodically regarding changes in medications including dosage changes, any new medications added, or any medications discontinued. This inquiry will include over-the-counter medications, herbal products, supplements and oxygen. The clinician will also ask the patient to periodically allow them to visualize all the medications the patient is currently taking. Medications will be visualized minimally at start of care, recertification/follow-up, resumption of care and upon any medication change. The visualized medications are compared to the current medication profile to ensure accuracy of the medication profile. Any discrepancies should be clarified with the patient's physician and documented in the clinical record. Therapists cannot receive medication verbal orders. The registered nurse (RN) CM (unsure if this meant case manager or clinical manager) or RN-DOO (director of operations) must contact the physician to verify, receive/write subsequent orders and amend the medication profile as indicated; and - When patients are admitted from acute or post acute care facilities it is the responsibility of the admitting clinician to assure they review the discharge paperwork from the facility to assure all medications with current dosages are captured. RECORD/PATIENT #1: Review of the hospital discharge medication list dated 09/24/2021 showed the following orders: - Melatonin (a sleep aid supplement) three milligrams (mg) at bedtime; - Colace (stool softener) 100 mg daily; - Miralax (laxative) 17 grams daily; - Cefdinir (antibiotic) 300 mg two times a day for seven days; and - Lisinopril (high blood pressure medication) 10 mg as needed. Review of the current agency medication profile did not include these medications except for cefdinir which the patient was no longer taking. Review of the registered nurse (RN) OASIS admission/comprehensive assessment dated 09/27/2021 showed: - No issues found during the drug regimen review; and - No documentation that medications were clarified with the physician. Review of the skilled nurse (SN) visits from 10/01/2021 through 10/15/2021 showed that medications were reviewed and no discrepancies were found. Observation and interview on 10/19/2021 beginning at 9:15 AM, during the patient’s home visit, showed the following discrepancies with the agency medication profile: - The patient’s medications were prefilled for him/her in a bubble pack for administration. The name and dosage of the contents were noted on the top of each bubble pack; - At the end of the visit, the surveyor requested the occupational therapist (OT) review the patient’s medications. The OT looked at the medications on his/her computer tablet and the patient’s agency medication list in the patient’s home folder, but failed to observe what was in the bubble packs that the patient was actually taking; - The medication profile showed an order for cefdinir 300 mg two times a day. The caregiver stated the patient no longer took this. The patient only took this for about ten days; - The patient's bubble packed medications showed he/she took docusate sodium 100 mg in the morning, super B complex at noon, and melatonin one daily at bedtime. These were not included on the medication profile; - The medication profile showed an order for duloxetine (can be used as an anti-depressant and for nerve pain) 30 mg daily with a dosage of 100 mg stool softener written below. This was incorrectly documented as duloxetine is not a stool softener; and - The medication profile showed orders to discontinue memantine (used for cognition) seven mg daily and pantoprazole (decreases stomach acid) 40 mg daily. The bubble pack listed these as current medications the patient took. The caregiver stated that the patient still took these medications. Review of the OT visits dated 10/15/2021 and 10/19/2021 showed medications were reviewed and no discrepancies found. RECORD/PATIENT #2: Observation and interview on 10/19/2021 beginning at approximately 1:30 PM, during the patient's home visit, showed the following medication discrepancies with the agency medication profile: -The medication profile showed an order for tramadol (pain medication) 50 milligrams (mg) one tablet every six hours. The medication label dated 09/29/2021 showed to take two tablets three times a day as needed. The patient’s spouse stated that the patient took two in the morning, two at noon, and two at night; -The medication profile showed an order for warfarin (blood thinner) three mg one tablet at bedtime. The patient’s spouse stated that it changed about two weeks ago to 2.5 mg six days a week and six mg on Sundays; -The medication profile showed an order for fluticasone nasal spray (used for allergy symptoms) one spray daily. The medication label dated 10/08/2021 showed to use two sprays two times a day. The patient stated that he/she had taken it this way for about ten years; -The patient had a bottle dated 07/21/2021 of naproxen (anti-inflammatory) 500 mg one tablet two times a day with food. The patient stated that he/she had taken this for about 15 years. This was not included on the medication profile; and -The patient’s spouse stated that the patient took extra strength Tylenol two tablets as needed. This was not included on the medication profile. During an interview on 10/20/2021 at 9:04 AM Registered Nurse (RN) B stated that at admission they compare the discharge medication list with what the patient has in the home. They look all medications including over the counter and herbal products. If there are discrepancies, they contact the physician. If a new medication is discovered they contact the physician to get approval and update the medication list in the home and in the computer system. During an interview on 10/20/2021 beginning at 11:02 AM the administrator stated that the clinicians ask to look at all medications including over-the- counter medications and supplements and compared it with whatever medication list is received with the referral. If there are medication discrepancies, the clinician would notify the physician. The clinicians review the medications at every visit. If there are new medications, the clinician would enter the new medication in the computer system and the system checks for interactions and alerts the clinician of the interactions.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on policy review, record review, observation, and interview, the agency failed to:- Provide each patient an individualized written plan of care (G572); - Include all the elements of an individualized plan of care (G574); - Include all patient care orders, including verbal orders, in the plan of care (G576); - Provide conformance with the physician orders on the plan of care (G578);- Promptly alert the relevant physician of changes in the patient's condition that may suggest a need to alter the plan of care (G590);- Provide a copy of written instructions outlining any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA (G618); and- Provide the name and contact information for the clinical manager to the patient (G622). The cumulative effect of these deficient practices has the potential to affect the provision of safe care for all patients served by the agency.

Plan of care 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 policy review, record review, and interview, the agency failed to review their initial assessments with physician/allowed practitioner for one (Record/Patient #1) and the agency failed to ensure that the patients received the home health services that were written on the individualized plan of care when the patient did not receive visits according to the visit frequency ordered on the plan of care in one (Record/Patient #4) of six full record reviews. This deficient practice has the potential to adversely affect the ordered care provided to all the agency's patients. RECORD/PATIENT #1: Review of the hospital discharge report dated and faxed to the agency on 09/24/2021 showed an order for the patient to discharge to home with home health. Review of the registered nurse (RN) OASIS (outcome assessment and information set, a federally mandated assessment) admission visit dated 09/27/2021 failed to show that the POC was discussed with the physician regarding the assessment. Review of a physician order dated 10/01/2021 showed an order for OT to evaluate the week of 10/11/2021. Review of the OT evaluation dated 10/15/2021 failed to show the OT POC was discussed with the physician regarding the evaluation. During an interview on 10/20/2021 beginning at 11:02 AM, the administrator stated that he/she would expect the RN and OT to discuss the POC with the physician. Findings included: Review of the agency's policy titled, "Plan of Care (POC)/Care Planning Process," revised 06/24/2021, showed in part the following: -Purpose: A POC will be developed through a care planning process, which is designed to provide care, treatment, and services that are appropriate for the patient's individual needs, as well as the patient's choice; -Purpose: To provide physician ordered care, treatment, and services through an organized process and plan; -The plan of care will be established through the use of the admission evaluation assessment and initiated by a physician/allowed practitioner order. When the physician/allowed practitioner refers a patient under a POC that cannot be completed until after the evaluation visit, the admitting clinician consults the physician/allowed practitioner to approve additions and modification to the original plan and documents the consultation in the initial assessment documentation or clinical note addendum. The additions and modifications are incorporated into the POC and sent to the physician/allowed practitioner for signature; -The POC will be forwarded to the physician/allowed practitioner for his/her review and should be received with dated signature within 30 days; -The individualized plan must at least include the following: The types of services, supplies, and equipment requires and the frequency and duration of visits to be made; -Modifications to the POC will be based upon the patient’s individual condition, problems, needs, and reassessments. Modifications to the POC will be documented in a Verbal Order as obtained from the physician/allowed practitioner; -If the patient has more than one physician/allowed practitioner actively providing orders for care and services, the attending physician/allowed practitioner should specify in the POC the name of any additional physician/allowed practitioners from which the agency can receive orders. The attending physician/allowed practitioner must give verbal approval for the agency to receive orders from any physician/allowed practitioner not specified in the POC. Orders are integrated from all physicians/allowed practitioners involved in the POC to assure the coordination of all services and interventions provided to the patient; and -The verbal start of care and nurse’s signature and date is documented in field 23 of the 485/POC. The Registered Nurse (RN) or qualified therapist would indicate the date the verbal order was received and/or the date the POC was reviewed and signed by the RN or therapist responsible for furnishing or supervising the ordered services. RECORD/PATIENT #4: Review of the POC dated 03/10/2021 to 05/08/2021, showed the patient was admitted to the agency on 03/10/2021 with type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar) with foot ulcer (open sore). Review of the POC dated 09/06/2021 t0 11/04/2021 showed: -Skilled Nurse (SN) two times a week for three weeks, then one time a week for six weeks; -Skilled Nurse to perform/teach diabetic ulcer- neuropathic care to great toe- irrigate/cleanse with normal saline, apply dry gauze, and cover with kerlix (dressing) and secure with tape or coban (stretchy dressing). Change dressing every day and as needed for dislodged dressing; -Skilled nurse to change dressing one time weekly and assess family to change other days; and -Electronically signed by the attending physician on 09/13/2021. Review of the clinical record showed: -On the week of 09/05/2021, only one SN visit was completed; -On the week of 09/12/2021, only one SN visit was completed; and -No communication note or physician order regarding the reason for the missed visits. During an interview and review of the record findings on 10/20/2021 at 1:40 PM, the administrator stated: -He/she found no missed visit notes or communication notes regarding the missed visits; -The agency should have clarified SN visits before sending POC to attending physician for signature; and -The visits were missed.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interview, the agency failed to ensure that each patient's written individualized plan of care (POC) included all the required elements in four (Records/Patients #2, #3, #4, and #6) of six full records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #3: Review of plan of care (POC) dated 09/03/21 showed patient had a primary diagnosis of type 2 diabetes mellitus with other skin ulcer (A chronic condition that affects the way the body processes blood sugar) and was admitted on 05/06/21. Other diagnoses included but not limited to: non- pressure chronic ulcer on other part of left lowered leg limited to breakdown of skin (an open sore that is not healing), urinary tract infection (an infection in any part of the urinary system, the kidneys, bladder, or urethra), chronic obstructive pulmonary disease (COPD) (a group of lung diseases that block airflow and make it difficult to breathe), and chronic kidney disease (damage to the kidneys that makes them unable to filter blood properly). Review of the clinical record showed: -Referring physician’s notes dated 05/03/21 showed blood glucose monitoring 3 times daily; -The start of care comprehensive assessment dated 05/06/21 showed blood glucose monitoring performed by patient daily with a range of 100 mg/dL to 250 mg/dL; -On skilled nurse visits dated, but not limited to, 09/03/21 and 10/12/21, the nurse documented blood glucose monitoring performed by the patient daily; -On skilled nurse visits dated, but not limited to, 09/07/21 and 10/14/21, the nurse documented blood glucose monitoring performed by the patient twice daily; and -The plan of care dated 09/03/21 failed to show a frequency for blood glucose monitoring and parameters for blood glucose including when to notify the physician. Review of clinical record showed: -On skilled nurse visits dated, but not limited to, 09/07/21 and 10/12/21, the nurse documented the use of oxygen by nasal cannula; and -Review of plan of care dated 09/03/21 showed no orders for use of oxygen via nasal cannula. During an observation of a home visit on 10/19/21, the patient stated to RN D that he/she uses oxygen at 2 liters as needed and at bedtime. Review of clinical record showed: -On skilled nurse visits dated, but not limited to, 09/15/21 and 10/14/21, the nurse documented the patient has impaired functional mobility, limitations with transfers, and uses wheelchair for mobility; -On skilled nurse visits dated, but not limited to, 09/15/21 and 10/08/21, the nurse documented the patient has urinary incontinence; -The plan of care dated 09/03/21 shows a diagnosis of chronic non-pressure ulcers to the left lower extremity; and -The plan of care fails to address the patient’s risk of further skin breakdown. During an observation of a home visit on 10/19/21, the patient told the registered nurse he/she has developed a sore on his/her buttocks. During an interview on 10/20/21 at 2:00 PM, the administrator stated she would expect the plan of care to include orders for blood glucose monitoring, parameters for blood glucose, oxygen use and address the patient’s high risk for skin breakdown. RECORD/PATIENT #4: Review of the comprehensive admission assessment, dated 03/10/2021, showed the following: -The patient was admitted to the home health agency (HHA) with a primary diagnosis of Type 2 Diabetes (a chronic condition that affects the way the body processes blood sugar) with foot ulcer (open sore); -Additional diagnoses included: Type 2 Diabetes Mellitus with other specified complications and osteomyelitis (infection of the bone); -Diabetes is managed with diet control; -Blood sugars checked daily; -Client’s usual blood sugar readings were 60 to 200; -Patient/caregiver compliant with all medication administration; and -At risk for emergency department visits or hospitalization due to polypharmacy (simultaneous use of multiple drugs). Review of verbal order, dated 05/25/2021, showed Metformin (antidiabetic) 500 milligram (mg) two times daily. Review of the recertification assessment, dated 09/01/2021, showed the following: -An additional diagnosis of essential hypertension (elevated blood pressure) was added; -Diabetes managed with oral antidiabetic; -Blood sugars checked daily; -Client’s usual blood sugar readings were 60 to 200; -Patient/caregiver compliant with all medication administration; and -At risk for emergency department visits or hospitalization due to multiple chronic comorbid disease processes and polypharmacy. Review of the POC, dated 09/06/2021 to 11/04/2021 failed to be individualized and show the following: -No order for daily blood sugars; -No parameters for blood sugars; and -No goals or interventions for endocrine system. During an interview and review of record findings on 10/20/2021 at 10:40 AM, the administrator stated: -The POC should be individualized and should have included goals and interventions for the endocrine system; -The POC should have had an order for the blood sugar; and -The POC should have had parameters for the blood sugars. RECORD/PATIENT #6: Review of the recertification assessment, dated 12/21/2020, showed the following: -Diagnoses included: encounter for therapeutic drug level monitoring, long-term current use of anticoagulant (blood thinner), and atrial fibrillation (irregular and often very rapid heart rhythm); -Patient/caregiver compliant with all medication administration; and -At risk for emergency department visits or hospitalization due to multiple chronic comorbid disease processes and polypharmacy. Review of the POC, dated 12/25/2020 to 02/22/2021, showed an order for warfarin (anticoagulant) 4 mg once daily. Review of the POC, dated 12/25/2020 to 02/22/2021, failed to be individualized and show the following: -No safety precautions for the anticoagulant; -No order for monitoring the warfarin; and -No goals or interventions regarding the warfarin. During an interview and review of record findings on 10/20/2021 at 10:47 AM, the administrator stated: -The POC should have included the safety precautions regarding the anticoagulant use; -The POC should be individualized and should have included goals and interventions for the warfarin; and -The POC should have had an order for monitoring the warfarin and who was going to be doing the monitoring of those levels. Findings included: Review of the agency policy titled, “Plan of Care/Care Planning Process,” revised 06/24/2021, showed in part: - A plan of care (POC) will be developed through a care planning process which is designed to provide care, treatment and services that are appropriate to the patient’s individual needs, as well as patient’s choice; - The purpose included to provide physician ordered care, treatment ad services through an organized process and plan; - Each patient must receive an individualized written POC, including any revisions or additions; - The individualized POC must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible disciplines, and measurable outcomes the the home health agency anticipates will occur as a result of implementing and coordination the POC; and - The POC must include all medications and treatments, patient-specific interventions and education, and measurable outcomes and goals identified by the home health agency and patient. Review of the agency policy titled, "Coordination of Care," revised 04/2019, showed a revised POC 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 home health agency and patient in the POC. RECORD/PATIENT #2: Review of the recertification registered nurse (RN) visit dated 09/29/2021 showed: - Diagnoses that included infection of the internal left knee prosthesis and long term (current) use of anticoagulant (blood thinning medication); - Had a surgical wound; - Wound assessment not completed due to caregiver had already completed wound care; and - No assessment of anticoagulant complications, when the last INR (a blood test used to monitor how well a blood thinning medication is working) results were obtained and if there were any change in medication dosage. Review of the recertification POC dated 10/04/2021 showed: - Diagnoses that included infection of the internal left knee prosthesis and long term (current) use of anticoagulant; - Safety measures included Coumadin (blood thinning medication) precautions, bleeding risks and wound precautions; - Medication orders included Coumadin three milligrams (mg) daily; - No interventions or goals regarding assessment of anticoagulant complications/bleeding risks or who was to monitor INR levels; and - A goal that wound status will improve as evidenced by a decrease in size, drainage, absence of infection and decreased pain but no interventions regarding wound assessments or how these goals would be achieved. During an interview on 10/20/2021 beginning at 11:12 AM, the administrator stated that he/she would expect the POC to continue to address wound assessments, assessment for signs of bleeding and who was monitoring the patients INRs.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to ensure all patient care orders, including verbal orders were recorded in the plan of care in one, (Record/Patient #5) of six full record reviews completed. This deficient practice has the potential to affect accurate and safe care is provided to all the agency's patients. Findings included: Review of the agency's policy titled, "Plan of Care (POC)/Care Planning Process," dated 06/24/2021, showed, in part: - Each patient must have an individualized written plan of care, including any revisions or additions; and - The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment. RECORD/PATIENT #5: Review of the plan of care dated 09/30/2021 to 11/02/2021 showed the patient was admitted on 09/30/2021 with primary diagnosis of aftercare following a kidney transplant and ESRD (end stage renal disease-when the kidneys are no longer functioning to remove toxins from the blood). Skilled nursing was ordered two times per week to obtain lab draws. Review of the clinical record showed: - On the start of care comprehensive assessment dated 09/30/2021, documentation showed lab was drawn from the left AC (antecubital space-bend of arm) and the patient had a right side of neck subclavian line (a central venous access for infusion-the subclavian vein near the collar bone is a frequently used site) with the dressing intact; - On the 10/05/2021 skilled nurse visit note, documentation showed lab was drawn from the left AC space and failed to show status of the right subclavian line; - On the 10/07/2021 skilled nurse visit note, documentation showed "labs obtained via PICC line. Purple lumen, flushed with 10 cc (cubic centimeters) of normal saline (mild salt solution), withdrawal 10 cc of blood and disposed of, withdrawal another 10 cc of blood and transferred 2 SST (serum separator tube), one lavender and one red top…..Flushed with 5 cc of heparin (blood thinner)….Flushed red lumen with 10 cc of normal saline." The note failed to show when the PICC was inserted or an assessment of the site. The note failed to show the status of the right subclavian line; and - On the 10/11/2021 skilled nurse visit note, an assessment showed the PICC line was a mid-line (non-central) catheter, no problems with site, the length of the exposed catheter was 1.0 centimeter, arm circumference was 13, the site was covered with a transparent dressing that was clean, dry, and intact, the dressing was changed 10/11/2021, both lumens flush easily and the purple lumen had good blood return. The lab was drawn through the PICC line with the same procedure as the 10/07/2021 visit. The note failed to show the status of the right subclavian line. Review of the plan of care dated 09/30/2021 to 11/28/2021 and interim physician orders from 09/30/2021 through 10/19/2021 failed to show orders for the PICC line and subclavian line for: - Dressing changes; - Assessments; - Use to draw labs; and - Flushes. During an interview on 10/20/2021 at 2:30 PM, the administrator stated that the PICC line: - Placement should have been documented in the skilled visit notes; - Orders should have been obtained for dressing changes, assessments, use to draw labs, and flushes; and - Was placed specifically for lab draws after the start of care.

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 policy review, record review, and interview the agency failed to ensure staff followed physician orders in, but not limited to, two (Record/Patient #2 and #3) of six full records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #3: Review of plan of care (POC) dated 09/03/21 showed the patient had a primary diagnosis of type 2 diabetes mellitus with other skin ulcer (A chronic condition that affects the way the body processes blood sugar) and was admitted on 05/06/21. Other diagnoses included but not limited to: non- pressure chronic ulcer on other part of left lowered leg limited to breakdown of skin (an open sore that is not healing), urinary tract infection (an infection in any part of the urinary system, the kidneys, bladder, or urethra), chronic obstructive pulmonary disease (COPD) (a group of lung diseases that block airflow and make it difficult to breathe), and chronic kidney disease (damage to the kidneys that makes them unable to filter blood properly). Observation of home visit on 10/19/21 at 10:15 AM by Registered Nurse D (RN D) showed RN D: -Cleansed wound with Medline wound cleanser; -Used barrier wipe to peri wound area; Placed opticell gauze in wound beds; -Covered wounds with bordered foam dressing; and -Wrapped foam dressing with bulk gauze and secured dressing with tape. Review of the clinical record showed: -Physician order dated 10/15/21 that stated skilled nurse (SN) to clean wounds with wound cleanser, apply barrier cream to peri wound (skin surrounding the wound), apply Medi Honey (wound dressing that contains honey) to wound bed, cover with bordered foam, wrap with kerlix (gauze roll) and secure with tape. SN to change twice weekly; -SN visit note dated 10/19/21 at 12:12 PM showed RN D obtained new orders for wound care that matched the wound care he/she performed during the home visit; and -RN D failed to perform the ordered wound care during the visit. During interview on 10/20/21 at 2:00PM, the administrator states she would expect clinician to follow current wound care orders on the plan of care. Findings included: Review of the agency policy titled, "The Provision of Wound and Skin Care," revised 02/25/2021, showed wound care orders are in effect until documentation supports wound care is no longer needed or an order is received to change the wound care or discontinue it. Review of the agency policy titled, "Physician Orders and Medical Supervision of the Plan of Care," revised 09/17/2021, showed: - Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner that establishes and periodically reviews the plan of care; and - Orders are integrated from all physicians involved in the plan of care to assure the coordination of all services and interventions provided to the patient. RECORD/PATIENT #2: Review of the plan of care dated 08/05/2021 showed diagnoses that included infection of the internal left knee prosthesis. Review of a physician order dated 09/16/2021 showed to cleanse the wound to left proximal tibia (just below the knee) with Vashe (a wound cleanser that contains sodium chloride and hypochlorous acid), let sit on wound two to three minutes, then pat dry with sterile gauze, apply zinc oxide (skin barrier) moisture barrier to protect intact skin around the wound, spiral cut hydrofera blue classic (antibacterial foam dressing), slightly moisten with distilled water, normal saline or sterile water, squeeze out excess water, apply to wound bed, cover with 4x4 gauze or ABD pad (large, absorbent pad), wrap with Kerlex (gauze wrap) and secure with paper tape, to be done daily. If drainage is soiling the outer dressing you may change the outer dressing only but leave the blue dressing in place until next dressing change. Review of the skilled nurse (SN) visit dated 09/20/2021 and the recertification visit dated 09/29/2021 showed the nurse cleansed with saline wound wash instead of Vashe and failed to document he/she applied the moisture barrier around the wound. During an interview on 10/20/2021 at 3:30 PM the administrator stated that staff should document wound care as stated in the order.

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 policy review, record review, home visit observation, and interview, the agency failed to ensure the physician was promptly alerted to changes in the patient's condition in three (Record/Patients #2, #3, and #6) of seven records reviewed. This deficient practice has the potential to affect the wellbeing of all the agency's patients. Findings included: Review of the agency policy titled, “Coordination of Care,” revised 04/2019, showed in the event the physical therapy assistant (PTA) or occupational therapy assistant (OTA) personnel identifies a problem or a change in condition with a patient, the PTA/OTA will immediately notify the supervising therapist and/or the clinical manager who will make a determination of the appropriate intervention. A physical therapist (PT) or occupational therapist (OT)/supervising therapist will perform an onsite visit to evaluate the patient or the clinical manager, PT or OT will coordinate care with the appropriate patient’s physician. RECORD/PATIENT #2: Review of the POC dated 10/04/2021 showed: - Diagnoses that included infection of the left knee internal prosthesis; and - PT visits two times a week for three weeks then one time a week for six weeks. Observation during the patient’s home visit on 10/19/2021 beginning at approximately 1:00 PM showed: - The patient told the PTA that his/her knee was swollen; - He/she reported a pain level of six out of ten (pain is rated on a scale of 0-10 with 0 meaning no pain and ten meaning the worst pain); and - The PTA assisted the patient to perform exercises while in bed. Review of the PTA visit note dated 10/19/2021 showed: - The patient reported his/her knee was fairly sore today and did not want to try to stand or ambulate; - Pain level was six out of ten and took two tramadol (pain medication) at 9:00 AM; and - No documentation that the PT, clinical manager or physician was notified of the patient’s complaint of his/her knee being swollen and not wanting to stand to ambulate. During an interview on 10/20/2021 beginning at 3:30 PM the administrator stated that he/she would expect the PTA to report the patient’s statement of his/her knee being swollen and not wanting to ambulate to the patient’s nurse or clinical manager. ECORD/PATIENT #6: Review of the plan of care (POC), dated 12/25/2020 to 02/22/2021, showed the following: -The patient was admitted to the agency on 08/27/2020; -His/her primary diagnosis was hypertensive chronic kidney disease (a high blood pressure caused by narrowing of arteries that carry blood to kidneys); -Other diagnoses included: Atrial fibrillation (irregular, often rapid heart rate that commonly causes poor blood flow), and long-term current use of anticoagulants; -Aspirin (used for minor aches, pains, and fevers. Also used as an anti-inflammatory or a blood thinner) 81 milligram (mg) once daily; and -Warfarin (anticoagulant) 4 mg once daily. Review of the skilled nursing note, dated 12/28/2020, showed the following: -Care Coordination with physician showed “not applicable”; -Protime ((PT) a test used to help detect and diagnose a bleeding disorder or excessive clotting disorder) was 44.1 (normal range = 11 to 13.5 seconds); -INR ((INR) the international normalized ratio is calculated from a protime) was 3.7 (normal range for someone on warfarin = 2.0 to 3.0); -Notified attending physician’s nurse, waiting for a call back; and -Patient currently on warfarin 4 mg daily. Review of verbal order, dated 12/30/2020 (two days after reported elevated PT and INR), showed no warfarin on Sundays, 2 mg on Wednesdays, and 4 mg all other days. During an interview and review of findings on 10/20/2021 at 10:47 AM, the administrator and vice president of clinical operations stated: -The physician should have been alerted to the elevated PT and INR on 12/28/2021; and -If unable to reach the physician, should have notified the case manager so he/she could attempt to reach the physician or the medical director to get new orders for the warfarin. Findings included: Review of the agency's policy titled, "Plan of Care (POC)/Care Planning Process," dated 06/24/2021, showed the home health agency staff will alert the physician(s)/allowed practitioner(s) to any changes in the patient's condition or needs that suggest the plan of care should be updated/altered. RECORD/PATIENT #3: Review of the plan of care dated 09/03/2021 to 11/01/2021 showed the patient was admitted to the agency on 05/06/2021. His/her current primary diagnosis was type 2 diabetes mellitus (a long-term medical condition in which the body doesn't use insulin properly, resulting in high blood sugar levels) with other skin ulcer, non-pressure ulcer of left lower leg (a skin breakdown not caused by pressure on the skin), and history of urinary tract infections (UTI). Review of the comprehensive start of care assessment dated 05/06/2021 showed the patient lived at home with paid caregivers. Review of the clinical record showed: - A skilled nurse visit note dated 10/08/2021 completed by LPN A (licensed practical nurse A) showed a urinary assessment of foul urine odor, burning and pain when the patient urinates, and a complaint of generalized back pain. A telephone call was made to the PCP (primary care physician) regarding the patient's symptoms and message was left on voicemail asking if the doctor wanted to get a UA (urinalysis-test urine for infection); - A skilled nurse visit note dated 10/12/2021 completed by LPN A showed a urinary assessment of urinary urgency, frequency, burning, and pain with urination. Communicated with the PCP and left a message that patient was still having pain with urination. Message left on voicemail; and - A skilled nurse visit note dated 10/14/2021 completed by LPN A showed a urinary assessment of urinary urgency, frequency, and pain with urination. LPN A failed to document any communication with the physician or other staff. During a home visit observation on 10/19/2021 with RN D (registered nurse D), the patient stated that he/she had urinary burning. RN D stated that he/she would leave a cup to obtain a urine specimen but none was left with the patient. Review of the skilled nurse visit note dated 10/19/2021 by RN D showed: - Urinary assessment of incontinence and burning/pain; and - The narrative showed that the patient had some urinary burning and an order for a UA was obtained. Review of the clinical record: - Failed to show documentation of a telephone call to the physician; and - Showed an order dated 10/20/2021 that they may obtain urine sample week of 10/18/2021 for a UA, C&S (culture and sensitivity) if needed for signs of UTI. At this point, 10/19/2021, the patient had gone 11 days without physician contact while having urinary tract infection symptoms. The patient experienced pain and discomfort as well as a continuing infection during this time period. When the urinalysis results were obtained on 10/21/2021, the urine showed signs of infection and was sent for culture and sensitivity. During an interview with LPN A on 10/20/2021at 11:35 AM, he/she stated that: - On 10/08/2021 during the skilled nurse visit, the patient complained of not feeling well and was in bed ill. The patient had seen the doctor just a few days prior to this. LPN A tried to call the PCP (MD A) and had to leave a message on the voicemail; - He/she encouraged the patient to go to the emergency room and he/she refused to go; - He/she tried to call the doctor again that afternoon but still was unable to talk to anyone; - On the 10/12/2021 skilled nurse visit, LPN A stated that the patient was up in the wheelchair and was feeling some better. The urinary burning wasn't as bad. He/she tried to call the physician (MD A) again and left a voicemail; - He/she encouraged the patient to go see the doctor; - He/she called clinical manager A and reported the patient's condition to him/her at 10:36 AM on 10/12/2021; - On the 10/14/2021 skilled nurse visit, he/she stated that the patient was still having problems but he/she felt some better. LPN A tried to call the PCP (MD A) office and when he/she could only leave a voicemail again, he/she was able to get a hold of a supervisor at the clinic and this person said they would investigate. Clinical manager A was called and informed; - LPN A stated that he/she has only worked at agency three months; - He/she only calls clinical manager A or the administrator if she has problems; and - He/she is not sure who the case manager is for this patient. An interview was conducted on 10/20/2021 at 9:20 AM with clinical manager A. He/she stated that: - There is no record of communication with LPN A regarding this patient on the team text messages for the dates of the visits; - He/she has no remembrance of talking to LPN A regarding patient #3 urinary problems or trouble getting a hold of the physician; - He/she would expect LPN A to communicate a suspected UTI to him/her; - Had not heard anything about patient #3 this morning, 10/20/2021; - RN C (registered nurse C) is the case manager for this patient, maybe LPN A contacted her. An interview with RN C was conducted on 10/20/2021 at 10:00 AM. RN C stated that he/she: - Was not sure he/she was aware of being case manager for Patient #3; - Did the start of care for the patient and had seen him/her off and on; - Was not really assigned to the patient that he/she was aware of; - Does not recall anyone calling her about patient #3; and - Would have put in a communication note about the problem, if LPN A had called. During an interview on 10/21/2021 at 11:10 AM, the administrator stated that: - An order was obtained by RN D on 10/20/2021. He/she "tracked down" the patient's other PCP (MD B-who had retired) and was able to obtain the order for a UA; - The urine was picked up from the patient's home and was processed on 10/21/2021 at 9:41 AM and was received by the agency at 10:44 AM; - The urinalysis showed signs of a urinary tract infection and was sent for culture and sensitivity test; and - The physician (MD B) had been contacted. During an interview on 10/20/2021 at 12:02 PM, the area vice president of clinical operations stated that: -LPN A did all that he/she could do; and -At some point, the management should have gotten involved to make sure the physician was contacted for orders.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on agency policy, home visit observation, and interview, the agency failed to provide the patient and representative (if any) current written treatments including wound care instructions in one (Record/Patient #3) of the three home visits conducted. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of agency’s policy titled, “Coordination of Care,” dated 04/2019, showed the agency must provide the patient and caregiver with a copy of written instructions outlining any treatment to be administered by agency personnel and personnel acting on behalf of the agency. RECORD/PATIENT #3: During a home visit observation on 10/19/2021 at 9:15 AM, review of the admission packet left in the home, failed to show written wound care orders. During an interview on 10/20/2021 at 9:10 AM, the administrator stated that all treatment instructions should be in writing in the home.

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 policy review, home visit observation and interview the agency failed to provide the name and contact information of the clinical manager in, but not limited to, three (Record/Patient #1, #2, and #3) of three home visit observations. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #3: Review of plan of care (POC) dated 09/03/21 showed patient had a primary diagnosis of type 2 diabetes mellitus with other skin ulcer (A chronic condition that affects the way the body processes blood sugar) and was admitted on 05/06/21. Other diagnoses included but not limited to: non- pressure chronic ulcer on other part of left lowered leg limited to breakdown of skin (an open sore that is not healing), urinary tract infection (an infection in any part of the urinary system, the kidneys, bladder, or urethra), chronic obstructive pulmonary disease (COPD) (a group of lung diseases that block airflow and make it difficult to breathe), and chronic kidney disease (damage to the kidneys that makes them unable to filter blood properly). During a home visit observation on 10/19/21 at 9:15 AM, review of the admission packet left in the home failed to show the name and contact information of the clinical manager. The observation findings were reviewed with the administrator on 10/19/21 at 1:00 PM. He/she acknowledged the findings and stated that he/she would expect the clinical manager’s name, business address and business phone number to be available, in writing, for the patient. Findings included: Review of the agency policy titled, "Coordination of Care," revised 04/2019, showed the HHA (home health agency) must provide the patient and caregiver a copy of written instructions including the name and contact information of the HHA's clinical manager. RECORD/PATIENT #1: Observation and interview on 10/19/2021 beginning at 9:15 AM , during the patient's home visit, showed the patient's home folder failed to include the contact information for the HHA's clinical manager. The occupational therapist (OT) stated that he/she had not seen this information in the home folders. RECORD/PATIENT #2: Observation and interview on 10/19/2021 beginning at approximately 1:00 PM, during the patient's home visit, showed the patient's home folder failed to include the contact information for the HHA's clinical manager. During an interview on 10/20/2021 beginning at 11:12 AM the administrator stated that they were updating the patient folders to include this information.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on policy review, home visit observation, and interview, the agency failed to ensure accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections were followed in three (Record/Patient #1, #2 and #3) of three home visit observations completed. This deficient practice has the potential to affect the health and safety of all the agency's patients. Findings included: Review of the agency's policy titled, "The Provision of Wound and Skin Care," dated 02/25/2021, showed; - A field is set up to work off of when providing wound care; - The field consists of a barrier on a clean hard surface on which all supplies necessary for the provision of wound care are laid; and - A wound care field is never set up on the floor and is not acceptable practice even with the placement of a barrier. RECORD/PATIENT #3: Review of plan of care (POC) dated 09/03/21 showed patient had a primary diagnosis of type 2 diabetes mellitus with other skin ulcer (A chronic condition that affects the way the body processes blood sugar) and was admitted on 05/06/21. Other diagnoses included but not limited to: non- pressure chronic ulcer on other part of left lowered leg limited to breakdown of skin (an open sore that is not healing), urinary tract infection (an infection in any part of the urinary system, the kidneys, bladder, or urethra), chronic obstructive pulmonary disease (COPD) (a group of lung diseases that block airflow and make it difficult to breathe), and chronic kidney disease (damage to the kidneys that makes them unable to filter blood properly). During home visit observation on 10/19/21 at 10:15 AM, Registered Nurse D: -Interviewed patient regarding current health status/complaints; -Entered patient responses into his/her tablet; -Laid tablet on top of patient’s folder located on an end table in patient’s living room without placing a barrier between the tablet and the folder; -Was preparing to do wound care; -Accessed a box containing dressing supplies sitting on the floor beside the patient; -Removed a pack of 4x4 gauze from box and placed the pack of gauze on the floor without placing a barrier between gauze and floor; and -Used 4x4 gauze to cleanse wound bed. During interview on 10/20/21 at 1400, the administrator stated he/she would expect the clinician to use a barrier under dressing supplies and tablet before placing them on surfaces in the patient’s home. Findings included: Review of the agency policy titled, “Bag Technique,” revised 09/08/2021, showed: - Nothing inside the bag should ever be dirty or soiled; - Staff should not re-enter the bag with used gloves; - Always perform hand hygiene before entering the bag; - Bags are placed on a barrier in the patient’s home; - Bags should not be placed on the floor in the patient’s home; - Staff cleanses hands prior to accessing materials from the supply bag; and - Wash hands again if you need to re-enter the bag for additional supplies. Do not go back into the bag without removing gloves and performing hand hygiene. Failure to follow this guideline will contaminate the interior contents of the bag. RECORD/PATIENT #1: Observation on 10/19/2021 beginning at 9:15 AM, during the patient’s home visit, showed the occupational therapist (OT) took the patient’s blood pressure then without changing gloves and sanitizing his/her hands reached into his/her supply bag to obtain a box of thermometer probe covers. He/she removed a probe cover from the box then placed the box back in his/her bag. The OT then reached into his/her bag again without removing his/her gloves or using sanitizer to remove the box of thermometer probe covers. After he/she removed another probe cover from the box, he/she placed the box back into his/her bag without removing his/her gloves or sanitizing his/her hands. At the end of the visit the OT picked up his/her bag off the barrier then sat the bag back on the table without a barrier. RECORD/PATIENT #2: Observation on 10/19/2021 beginning at approximately 1:30 PM, during the patient’s home visit, showed the patient signed the tablet then without cleansing the computer tablet, the physical therapy assistant (PTA) lay the tablet inside his/her supply; bag. The clinician then removed the barrier from beneath his/her bag, then sat the bag on the floor without a barrier. During an interview on 10/20/2021 beginning at 11:02 AM the administrator stated that the bags should be placed on a barrier or a clean, disinfected area. Staff should only re-enter their bags with clean hands. The tablets should be cleaned. The area vice president of operations stated that the tablets should not be placed in the clinician’s bag.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on policy review, record review, observation, and interview the agency failed to meet the requirements for the Condition of Participation: Skilled Professional Services, when the agency failed to: -Assume responsibility for ongoing interdisciplinary assessment of a patient (G706); -Provide patient and caregiver education (G714); and -Ensure the skilled professionals communicated with all physicians/allowed practitioners involved in the plan of care related to the current plan of care (G718). The cumulative effect of this deficient practices has the potential to affect all of the agency's patients.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on policy review, record review, home observation, and interview the agency failed to ensure staff provided ongoing assessments for three (Record/Patients #2, #3, and #4) of six full records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #4: Review of POC, dated 09/06/2021 to 11/04/2021, showed: -The patient had a primary diagnosis of type 2 diabetes mellitus with foot ulcer (A chronic condition that affects the way the body processes blood sugar) and was admitted on 03/10/21. Other diagnoses included but not limited to: non- pressure chronic ulcer on other part of left foot with fat layer exposed (an open sore that is not healing), osteomyelitis (infection of the bone), and acquired absence of other right toe(s); and -Skilled Nurse to irrigate/cleanse great toe with normal saline, apply dry gauze, cover with kerlix (dressing) and secure with tape or coban (stretchy dressing) one time weekly and the family to change the other days and as needed for dislodged dressing. Review of skilled nursing note, dated 09/15/2021, showed: -The patient had a open wound to his/her left foot; -The patient was to have his/her left great toe amputated (removed) next Tuesday (09/21/2021); and -The nurse would do a follow up visit next Friday (09/24/2021). Review of the clinical record showed no documentation of the follow up visit on 09/24/2021 and no new surgical wound care orders following the amputation of the left great toe. During an interview and review of findings on 10/20/2021 at 10:40 AM, the administrator and vice president of clinical operations stated: -They would have expected staff to make a follow up visit the week the patient had his/her toe amputated; -They would have expected staff to get in contact with surgeon to see if any new dressing orders were needed; and -They had no documentation of a visit being made the week the patient had his/her toe amputated. RECORD/PATIENT #3: Review of plan of care (POC) dated 09/03/21 showed the patient had a primary diagnosis of type 2 diabetes mellitus with other skin ulcer (A chronic condition that affects the way the body processes blood sugar) and was admitted on 05/06/21. Other diagnoses included but not limited to: non- pressure chronic ulcer on other part of left lowered leg limited to breakdown of skin (an open sore that is not healing), urinary tract infection (an infection in any part of the urinary system, the kidneys, bladder, or urethra), chronic obstructive pulmonary disease (COPD) (a group of lung diseases that block airflow and make it difficult to breathe), and chronic kidney disease (damage to the kidneys that makes them unable to filter blood properly). During home visit observation on 10/19/21 at 10:15AM, Registered Nurse D: -Asked patient if she had any wounds on her bottom, since she sits most of the day; -The patient stated she did have a wound on her bottom that caused her to have pain; -The nurse asked if she was putting anything on it and the patient replied she was putting triple antibiotic ointment on it; and -The nurse failed to assess the reported wound on the patient’s buttocks. The same home visit observation also showed three separate wounds present in a cluster when the dressing was removed from the left lower extremity. Clinical record review on 10/19/21 showed: -No wound measurements for left lower extremity ulcers week of 09/19/21 and 10/10/21; and -Skilled nurse visit notes dated, but not limited to, 10/06/21 and 10/08/21 failed to show measurements for 2 of the 3 wounds present on the patient’s left lower extremity. During an interview on 10/20/21 at 2:00 PM, the administrator stated that: - Wound measurements are expected to be done weekly; -He/she would expect each wound on the left lower extremity to be measured individually; and -He/she would expect each wound’s size and appearance to be documented in the clinical record. Findings included: Review of the agency policy titled, "The Provision of Wound and Skin Care," revised 02/25/2021, showed in part in accordance with best practice and standard of care, wounds will be measured a minimum of one time a week, preferably on the first visit of the week. Patients who are seen at a frequency of one time a week should have the wound measured at that visit. RECORD/PATIENT #2: Review of the skilled nurse visit dated 09/13/2021 for the week of 09/12/2021 showed the wound assessment of the left knee failed to include measurements of the wound. Review of the recertification registered nurse (RN) visit dated 09/29/2021 showed: - Diagnoses that included infection of the internal left knee prosthesis and long term (current) use of anticoagulant (blood thinning medication); - Had a surgical wound; - No wound assessment with measurements completed due to caregiver had already completed wound care; and - No assessment of anticoagulant complications, when last INR (a blood test used to monitor how well a blood thinning medication is working) results were obtained and if there were any change in medication dosage. Review of the recertification plan of care dated 10/04/2021 showed: - Diagnoses that included infection of the internal left knee prosthesis and long term (current) use of anticoagulant; - Safety measures included Coumadin (blood thinning medication) precautions, bleeding risks and wound precautions; - Medication orders included Coumadin three milligrams (mg) daily; - No interventions or goals regarding assessment of anticoagulant complications/bleeding risks or who was to monitor INR levels; and - A goal that wound status will improve as evidenced by a decrease in size, drainage, absence of infection and decreased pain but no interventions regarding wound assessments or how these goals would be achieved. Review of the skilled nurse visits dated 10/6/2021 and 10/13/2021 showed no assessment for anticoagulant complications, when the last INR had been completed or whether changes to the Coumadin dosage had been made. Per interview conducted during the patient’s home visit on 10/19/2021 beginning at approximately 1:30 PM, the patient stated that he/she had doctor appointments about every week and had his/her INRs drawn at the laboratory. This was his/her choice as that was what he/she was used to doing. His/her next INR would be on Monday. The home health nurse had done the INR before and had talked to him/her about doing them when the weather got bad this winter. During an interview on 10/20/2021 beginning at 11:12 AM, the administrator stated that wound measurements should be done weekly. The nurse should assess for signs and symptoms of bleeding and address monitoring of INRs. This information should be documented in the nurses' notes.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to ensure the skilled professional assumed responsibility for patient and caregiver education in two (Records/Patients #3 and #6) of six full records reviewed. This deficient practice has the potential to affect the knowledge and compliance with the treatment plan of all the agency’s patients. Findings included: Review of the agency’s policy titled, “Coordination of Care,” revised 04/2019, showed in part the following: -The patient’s care and services will be coordinated among staff and branches; -To ensure consistent documentation, communication, coordination, and retrieval of significant administrative and patient/family information; and -Ensure that each patient, and his/her caregiver(s) where applicable, receive ongoing education and training provided by the agency, as appropriate, regarding the care and services identified in the plan of care. The agency must provide training, as necessary, to ensure a timely discharge. RECORD/PATIENT #6: Review of the POC, dated 12/25/2020 to 02/22/2021, showed the following: -Primary diagnosis was Hypertensive Chronic Kidney Disease (a high blood pressure caused by narrowing of arteries that carry blood to kidneys); -Effective 12/27/2020- Skilled Nurse (SN) one time a week for nine weeks; -Licensed professional to report vital signs that fall outside the following established parameters: systolic blood pressure less than 90 or greater than 180 and diastolic blood pressure less than 50 or greater than 100; -Clonidine (antihypertensive) 0.1 milligram (mg) twice daily; -Diltiazem CD (antihypertensive) 300 mg one daily; and -Lisinopril (antihypertensive) 20 mg daily. Review of the clinical notes 12/25/2020 through 02/22/2021 failed to show any teaching regarding how to monitor/take the patient’s blood pressure. During an interview and review of the clinical record findings on 10/20/2021 at 10:47 AM, the administrator and vice president of clinical operations, stated that they would have expected teaching to be done regarding monitoring/taking the patient’s blood pressure. RECORD/PATIENT #3: Review of plan of care (POC) dated 09/03/21 showed the patient had a primary diagnosis of type 2 diabetes mellitus with other skin ulcer (A chronic condition that affects the way the body processes blood sugar) and was admitted on 05/06/21. Other diagnoses included but not limited to: non- pressure chronic ulcer on other part of left lower leg limited to breakdown of skin (an open sore that is not healing), urinary tract infection (an infection in any part of the urinary system, the kidneys, bladder, or urethra), chronic obstructive pulmonary disease (COPD) (a group of lung diseases that block airflow and make it difficult to breathe), and chronic kidney disease (damage to the kidneys that makes them unable to filter blood properly). Review of skilled nurse (SN) visits dated, but not limited to, 09/28/21 and 10/01/21 showed: -The patient has diabetes mellitus; -The patient’s diabetes is managed by insulin; -The insulin is administered by an insulin pen injection; -The patent is able to self-administer insulin injections; -The nurse failed to document return demonstration by the patient on proper insulin administration; and -The nurse failed to document that education was provided on rotating injection sites. Review of the plan of care dated 09/03/21 showed: -“SN may instruct and reinforce medication teaching related to the use of medications, dosage, frequency, purpose, side effects, and to report complications”; and -The plan of care failed to include patient specific teaching on insulin administration including rotation of injection sites. During home visit on 10/19/21, observation showed: -RN D assessed patient’s abdomen and noted a hard lump under surface of the skin; -RN D stated that lump felt like a medical “port” (a device placed under the skin to draw blood and give treatments) and patient stated that he/she did not have a port; -Patient stated that the lump is from giving himself/herself insulin injections; -Patient stated that he/she tries to give himself/herself shots but he/she always bends the needle; and -RN D failed to provide education on the importance of rotating insulin injection sites. During an interview on 10/20/21, the administrator stated that he/she would expect education to be provided on rotating insulin injection sites and he/she would expect the education intervention to be on the patient’s plan of care.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on agency policy review, record review, and interview, the agency failed to assure agency clinicians effectively communicated with all physicians/allowed practitioners related to the patient’s current plan of care (POC) for one (Record/Patient #6) of six full record reviews. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s policy titled, “Plan of Care (POC)/Care Planning Process,” revised 06/24/2021, showed in part, the following: -Modifications to the POC will be based upon the patient’s individual condition, problems, needs, and reassessments. Modifications to the plan of care will be documented in a Verbal Order as obtained from the Physician/allowed practitioner; -The home health agency staff will alert the physician(s)/allowed practitioner(s) to any changes in the patient’s condition or needs that suggest the POC should be updated/altered; and -Revisions to the POC will be communicated to the patient/caregiver and physician(s)/allowed practitioner(s) issuing orders for the POC. RECORD/PATIENT #6: Review of the clinical record showed the patient was admitted to the agency on 08/27/2020 with a primary diagnosis of hypertensive chronic kidney disease (a high blood pressure caused by narrowing of arteries that carry blood to kidneys). Other diagnoses included: Atrial fibrillation (irregular, often rapid heart rate that commonly causes poor blood flow), and long-term current use of anticoagulants. Review of the POC, dated 12/25/2020 to 02/22/2021, showed the patient was on warfarin (anticoagulant) 4 milligram (mg) once daily. Review of a skilled nursing note, dated 02/04/2021, showed: -New bruising; -New onset of 1+ edema (swelling) to both right and left lower extremities; and -No care coordination communicated with the physician. Review of the clinical record, failed to show any communication to the physician regarding the new bruising and the new onset of edema. Review of a skilled nursing note, dated 02/19/2021, showed: -The patient informed the nurse that he/she had felt sick the last week, with a dry cough, runny nose, swollen glands, and a sore throat. The patient informed the nurse that he/she had missed his/her appointment on 02/15/2021 due to the snow; -Left a message with the patient’s physician regarding his/her sore throat, awaiting return call; and -No further documentation of follow up with physician concerning sore throat. During an interview and review of the findings, on 10/20/2021 at 10:47 AM, the administrator and vice president of clinical operations, stated: -They would have expected the physician to be notified of the new bruising, new onset of edema, and the sore throat; and -There was no documentation for follow up with the physician related to the bruising, edema, or sore throat.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on the agency policy, the State of Missouri instructions for the approved Home Health Aide/Hospice Aide competency evaluation, employee files, and interview, the agency failed to ensure that the home health aide completed a competency evaluation program in, one (Employee/Aide A) of one home health aide employee files reviewed. This deficient practice has the potential to affect the personal care performed on all the agency's patients receiving aide services. Findings included: Review of the agency's policy titled, "Competency Plan," revised 02/2020, showed in part the following: -Upon hire and prior to patient assignment, a Registered Nurse (RN) will observe skills and tasks utilizing the Home Health Aide Skills Checklist; and -The Home Health Aide Skills Checklist may be completed in a patient's home or in a lab setting with a pseudo-patient (a person trained to participate in a role-play situation, or a computer-based mannequin device. A pseudo-patient must be capable of responding to and interacting with the home health aide) at the discretion of the supervising RN. Review of the Missouri approved Home Health Aide/Hospice Aide competency evaluation form (Effective January 13, 2018) shows it includes two parts, written aide competency evaluation and basic skills test. (This competency evaluation was updated 08/01/2021). The skills portion of the exam instructs the agency to have the qualified registered nurse observe the aide performing all tasks listed while providing care to a patient. The registered nurse must document specific comments regarding the tasks and the aide's performance, identifying the patient by initials, enter the date the aide satisfactorily completed the task, and sign each task observed. The aide must complete all of the tasks to pass the basic skills test. An aide is not qualified and cannot provide care independently unless all tasks have been satisfactorily completed. EMPLOYEE FILE AIDE A: Review of Aide A employee file showed the following. Aide A: -Was employed on 05/24/2021; -The first independent patient contact was 06/03/2021; -The basic skills test failed to show completion of the following tasks: bed bath, sponge bath, file nails, denture care, pericare, incontinence care, ambulation with a walker, ambulation with a cane, passive range of motion, and positioning technique in bed; and -The home health aide, Aide A, failed to complete the basic skills evaluation before the first independent patient contact. During an interview on 10/20/2021 at 10:39 AM, the findings were reviewed with the administrator and the area vice president of clinical operations. The administrator acknowledged the findings and provided no additional information.

Org. had partial/extended survey CFR(s): 484.80(f)(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or This ELEMENT is not met as evidenced by: Based on the results of this extended level survey, resulting in noncompliance with three Conditions of Participation: Care planning, coordination of services, and quality care; Skilled Professional Services; and Organization and administration of services, the agency may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. The restriction ends 10/21/2023.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on results of this extended level survey, job description, policy review, and interviews, the agency failed to organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care when the agency failed to show adequate governing body, administrative, and clinical manager oversight to patients resulting in three Conditions of Participation citations. The following standard level deficiencies were cited under this condition of participation: -Clinical manager: One or more qualified individuals must provide oversight of all patient care services and personnel, oversight must include (G958); -Clinical manager: Must assure the development, implementation, and updates of the individualized plan of care (G968); -That the agency's qualifying service for Medicare was provided in its entirety by the agency's own employees (G982); and -All home health services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice (G984).

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on current survey findings, clinical manager job description review, home visit observations, and interview, it cannot be assured the clinical manager has effectively assumed responsibility for oversight of all patient care services, coordinating patient care, and coordinating referrals of the home health agency. The agency failed to show the clinical managers provided oversight for assuring that the patient needs were continually assessed and the development, implementation, and updates of the individualized plan of care were completed. The agency failed to provide the clinical manager's name and contact information so the patient/caregiver would know who to contact for concerns about their treatment and services on three (Records/Patients #1, #2, and #3) out of three home visit observations conducted. This deficient practice has the potential to affect all the patients receiving services from the agency. Findings included: Based on current survey findings, the agency failed to comply with three Conditions of Participation: -§484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care; - §484.75 Condition of Participation: Skilled Professional Services; and -§484.195 Condition of Participation: Organization and Administration of Services. Review of the clinical manager job description, dated March 2019, showed: -Responsible for the supervision, management, coordination and provision of quality patient care while demonstrating fiscal responsibility and maintaining the highest standards of care and ensuring compliance with all policies, procedures, and regulatory requirements; -This role also accountable for measuring, monitoring, and managing quality of patient care, achievement of key performance indicators, and organizational clinical performance; -Oversees scheduling activities to ensure patient needs are met. Reviews assignments as appropriate with the patient services coordinator and professional and support staff; -Responsible for review of documentation of other staff members including the Oasis data collection, starts of care, re-certification, physician orders, daily progress notes, and other related documents ensuring appropriateness of care, delivery, and documentation requirements are met; -Oversees and assists clinicians in establishing immediate and long-term patient goals, setting priorities and developing Plan of Care (POC). Responsible to oversee the management and delivery of patient care. Oversees the assignment of the appropriate clinical pathways and implementation of the POC and physician's orders for patients; -Oversees clinicians in the provision of care and services requiring substantial and specialized professional skills set (per applicable discipline practice act and standards of practice) and in accordance with the POC to the appropriate staff; -Oversees the professional staff to ensure timely communication of changes in the patient condition to the physician and receipt of necessary changes in orders. Ensures communication of changes in the POC to the appropriate staff; -Evaluates, and regularly re-evaluates the needs of the patient; initiates, develops, implements and makes necessary revisions to the patient's POC in collaboration with the clinicians providing care; -Leads regular patient care conferences and promotes coordination and communication of information relevant to the care of the patient to ensure quality of care; and -Monitors and evaluates employee performance, including through on-site evaluations. Holds employees accountable for the attainment of defined goals and objectives. RECORD/PATIENT #1: Observation and interview on 10/19/2021 beginning at 9:15 AM , during the patient's home visit, showed the patient's home folder failed to include the contact information for the HHA's clinical manager. The occupational therapist (OT) stated that he/she had not seen this information in the home folders. RECORD/PATIENT #2: Observation and interview on 10/19/2021 beginning at approximately 1:00 PM, during the patient's home visit, showed the patient's home folder failed to include the contact information for the HHA's clinical manager. RECORD/PATIENT #3: During a home visit observation on 10/19/21 at 9:15 AM, review of the admission packet left in the home failed to show the name and contact information of the clinical manager. During an interview on 10/20/2021 at 9:20 AM, clinical manager A, stated: -He/she had only been with the agency since the first part of July; -The agency had two clinical managers; -He/she had not had much experience in home health, his/her background was hospice; -The clinical managers work mainly in the office; and -The clinical managers mainly do the supervisory visits.

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 current survey findings, clinical manager job description review, and interview, it cannot be assured that the clinical managers have assured the development, implementation, and updates to the individualized plan of care. This deficient practice has the potential to affect all patients served by the agency. Findings included: Based on the current survey findings, (a condition level citation of 484.60- Care Planning, Coordination of Services, and Quality of Care- G570) the clinical manager failed to: -Ensure completion of individualized care plans specify the care and services necessary to meet the patient specific needs as identified in the comprehensive assessment (G572); -Ensure that each patient's written individualized plan of care (POC) included all the required elements (G574); -Ensure all patient care orders, including verbal orders were recorded in the plan of care (G576); -Ensure staff followed physician orders (G578); -Ensure the physician was promptly alerted to changes in the patient's condition (G590); -Ensure staff provided the patient and representative (if any) the current written treatment plan (G618); and -Ensure the clinical managers name and contact information was left in the patient's home (G622). Review of the agency's Clinical Manager's job description, dated March 2019, showed: -Responsible for the supervision, management, coordination and provision of quality patient care while demonstrating fiscal responsibility and maintaining the highest standards of care and ensuring compliance with all policies, procedures, and regulatory requirements; -This role also accountable for measuring, monitoring, and managing quality of patient care, achievement of key performance indicators, and organizational clinical performance; -Oversees scheduling activities to ensure patient needs are met. Reviews assignments as appropriate with the patient services coordinator and professional and support staff; -Responsible for review of documentation of other staff members including the Oasis data collection, starts of care, re-certification, physician orders, daily progress notes, and other related documents ensuring appropriateness of care, delivery, and documentation requirements are met; -Oversees and assists clinicians in establishing immediate and long-term patient goals, setting priorities and developing Plan of Care (POC). Responsible to oversee the management and delivery of patient care. Oversees the assignment of the appropriate clinical pathways and implementation of the POC and physician's orders for patients; -Oversees the professional staff to ensure timely communication of changes in the patient condition to the physician and receipt of necessary changes in orders. Ensures communication of changes in the POC to the appropriate staff; and -Evaluates, and regularly re-evaluates the needs of the patient; initiates, develops, implements and makes necessary revisions to the patient's POC in collaboration with the clinicians providing care. During an interview on 10/20/2021 at 9:20 AM, clinical manager A, stated: -He/she had only been with the agency since the first part of July; -The agency had two clinical managers; -He/she had not had much experience in home health, his/her background was hospice; -The clinical managers work mainly in the office; and -The clinical managers mainly do the supervisory visits.

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on policy review and interview the agency failed to ensure that their qualifying service for Medicare was provided in its entirety by the agency's own employees. This deficient practice has the potential to affect all patients served by the agency. Findings included:Review of the agency policy titled, "Coordination of Care," revised 04/2021, showed in part the Director of Operations is responsible for the overall coordination of patient care and services, including care provided through written agreement. Review of aspen central office agency information showed skilled nursing was the agency's qualifying service for Medicare.During an interview on 10/18/2021 beginning at 1:00 PM, the administrator stated that they had a contract nurse. The administrator stated that physical therapy was their qualifying service for Medicare. He/she would look for information that showed the state office was notified of the change in qualifying service. During an interview on 10/18/2021 at 1:40 PM, the administrator stated that he/she could not find information that the state office was notified of the change in qualifying service. He/she provided an email dated 10/18/2021 that the state office was notified to change their qualifying service to physical therapy.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on state law, the agency policy, employee file review, and interview, the agency failed to ensure all staff had the Employee Disqualification List (EDL) checked prior to hire for one (Employee #1) of four employee files reviewed and failed to ensure all staff had the Family Care Safety Registry (FCSR) checked prior to date of first patient contact, in two (Employee #1 and #2) of four employee files reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of Section 192.2490.12 RSMo: "No person, corporation, organization, or association who received the employee disqualification list under subdivisions (1) and (7) of subsection 11 of this section shall knowingly employ any person who is on the employee disqualification list." Review of Section 192.2495, RSMo: Requires regulated health care employers, such as long-term care facilities, hospitals, home health agencies, hospices, adult day care providers, and in-home services providers and consumer directed services programs under contract with the Department of Health and Senior Services, to obtain background screenings prior to hiring an employee. In-home services providers, consumer directed services providers, and home health agencies are required to conduct background screenings by checking the Family Care Safety Registry (FCSR) (Section 210.900 - 210.936, RSMo). Review of the agency's policy titled, "Criminal Background Check Policy" revised 07/2017, showed in part the following: -The agency believes that hiring qualified individuals contributes to the agency's overall strategic success; - Criminal background checks serve as an important part of the selection process; - The information the agency collects helps the agency promote a safe work environment for their current and future employees; -Criminal background checks also help the agency obtain information necessary to determine an applicant's overall employability and to ensure the protection of the agency's physical property, proprietary information, other assets and, their patient's safety; and -The agency complies with all applicable federal, state, and local laws. Review of the agency's policy titled, "Background Checks," revised 06/24/2021, showed in part the following: -When state specific requirements are more stringent and/or the approved third party vendor background check do not meet the state requirements, in addition to the approved third party vendor background check - additional state, federal, and/or FBI background checks may be required- Agencies must adhere to the most stringent regulations (state, federal, accreditations, professional practice, ect.); see also the state specific regulations located in this policy; and -Missouri: Prior to allowing any person who has been hired as a full-time, part-time, temporary, or contract staff to have contact with any patient, the agency shall request a criminal background check and make an inquiry to the department of heal and senior services whether the person is listed on the employee disqualification list. EMPLOYEE #1 (E1): Review of the E1's personnel file showed: -Registered Nurse (RN) and agency administrator; -Date of hire: 04/05/2021; -Date of first patient contact: None documented; -Failed to show EDL results prior to hire; and -Failed to show FCSR results prior to patient contact. EMPLOYEE #2 (E2): Review of the E2's personnel file showed: -Physical Therapist (PT); -Date of hire: 06/14/2021; -Date of first patient contact: 06/22/2021; -Failed to show FCSR results prior to patient contact. The findings were reviewed with the administrator and the area vice president of clinical operations on 10/20/2021 at 10:39 AM. A FCSR was provided to the survey staff for E#1 and E#2 on 10/21/2021, both were dated 10/20/2021.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure a completed discharge summary was sent to the patient’s primary care practitioner within five days of the patient’s discharge in two (Record/Patient #6 and #7) of two discharge records reviewed. This deficient practice has the potential to affect the discharge needs of all patients served by the agency. Findings included: RECORD/PATIENT #6: Review of the clinical record showed that the patient was admitted to the agency on 08/27/2021 with a diagnosis of hypertensive chronic kidney disease (a high blood pressure caused by narrowing of arteries that carry blood to kidneys) with orders for skilled nursing. The patient was discharged on 02/22/2021. Further review of the clinical record showed: -A episode summary report, which showed the patient was discharged to home due to goals being met; and -No evidence to prove when this episode summary was sent to the physician or proof that it was sent to the physician. Findings included: RECORD/PATIENT #7: Review of the discharge summary dated 09/29/2021 showed the patient was discharged from home health services on 09/24/2021. Review of an event-stages history report provided by the administrator showed a section that showed process appropriate summary to physician dated 09/29/2021. There was no documentation to show the discharge summary was actually sent to the physician. During an interview on 10/20/2021 at approximately 4:00 PM, the administrator stated that this was the only way he/she knew to show the discharge summary had been sent. During an interview on 10/21/2021 at 1:05 PM the physician’s office manager stated that they did not have a discharge summary from the agency.