Every finding on record at St. Andrews & Bethesda, LLC

An extended survey for Medicare recertification for the home health provider was completed on 12/04/2023. The provider had 89 current patients. One condition-level deficiency was identified at an immediate jeopardy (IJ) level as follows: - §484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care. An immediate jeopardy level for actual harm to one patient (Patient #5) and likelihood for future harm to other patients was identified during the survey. The findings were confirmed as immediate jeopardy by the Centers for Medicare and Medicaid Services (CMS). On 11/29/2023 at 2:10 PM the administrator was informed verbally and in writing via the IJ Template, of the findings identified at an immediate jeopardy level. A formal written removal plan was submitted by the provider prior to the survey exit. This removal plan was reviewed by CMS and it was determined at the time of the survey exit on 12/04/2023, that a satisfactory removal plan had been initiated related to the immediate jeopardy findings. The condition-level deficiency identified above remains as cited. A home health provider that is found out of compliance with any Condition of Participation evaluated as part of a standard survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at §484.80(f)(3) – see Tag G788. The Emergency Preparedness regulations were also reviewed as part of the Medicare recertification survey completed on 12/04/2023. One standard level deficiency was identified.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on employee file review and interview the home health provider failed to ensure that one of four employee files reviewed contained emergency preparedness training on orientation (E-2). This deficient practice has the potential to affect all patients served by the provider. Findings included: E-2: Review of the employee file showed that E-2 was hired on 03/13/2023. Review of the employee’s training hours showed that the employee failed to complete any emergency preparedness training. The provider failed to ensure that any emergency preparedness education was completed during orientation. During an interview on 11/29/2023 at 4:25 PM, the human resources representative stated, “the employees have one year to complete all of the trainings except required courses like Dementia training.”

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 home health provider failed to ensure the initial assessment visit was held within 48 hours of the referral or within 48 hours of the patient’s return home in two of five records reviewed (Records/Patients #3 and #4) and failed to ensure a registered nurse (RN) conducted the initial assessment visit in one of five records reviewed (Record/Patient #5). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the home health provider’s policy titled, “Assessment,” revised 01/2023, showed in part: - Admission assessments should be performed by a RN within 48 hours of the time of the referral, the patient’s return home or the physician-ordered start of care date; and - If the physician orders only therapy services, the initial comprehensive assessment may be completed by an appropriate rehabilitation skilled professional (physical therapist (PT) or speech-language pathologist/speech therapist (SLP) within 48 hours of the time of referral, the patient’s return home or the physician-ordered start of care date. RECORD/PATIENT #3: Review of the clinical record showed a referral for home health services dated 11/09/2023. Review of the initial assessment showed, in part, the following: - Item M0102, on the Outcome and Assessment Information Set (OASIS; a standardized data collection tool), showed the physician ordered start of care date was answered as not applicable – no specific start of care date ordered by the physician; - OASIS item M1000 showed the patient was discharged from a skilled nursing facility; - OASIS item M1005 showed the inpatient discharge date was 11/10/2023; - OASIS item M0090 showed the assessment was completed on 11/14/2023 (96 hours after the patient’s return home); and - The provider failed to complete the initial visit assessment within 48 hours. RECORD/PATIENT #4: Review of the clinical record showed, in part: - The patient was discharged from a nursing and rehabilitation facility on 10/04/2023; - A referral to the home health provider was received by the provider on 10/13/2023; - The initial visit assessment was completed on 10/16/2023 (72 hours after the referral was received); and - The provider failed to complete the initial visit assessment within 48 hours. During an interview on 11/30/2023 beginning at 1:00 PM, the clinical manager stated that he/she would expect the nurse to call the physician and delay the admission if needed. RECORD/PATIENT #5: Review of the clinical record showed, in part: - A referral for home health services dated 08/24/2023; - The referral had orders for PT evaluation and treatment effective 08/24/2023, skilled nursing (SN) evaluation and treatment effective 08/24/2023 and occupational therapy (OT) evaluation and treatment effective 08/24/2023; - The initial assessment visit was completed by a PT; and - The provider failed to ensure the initial assessment visit was completed by a RN. During an interview on 11/28/2023 at 12:30 PM, the clinical manager stated that they try to get someone in there to admit the patient as quickly as possible when an evaluation order is received. He/she was not aware the RN must conduct the initial assessment unless it was a therapy only referral. He/she stated that they had always had therapy do the initial assessment.

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 home health provider failed to conduct an accurate review of all medications taken by the patient in, but not limited to, three of five records reviewed (Records/Patients #1, #2, and #3). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Medication Management – Patient Information,” revised 01/2023, showed in part: - During the initial assessment visit, the registered nurse/therapist generates a list of the patient’s current medications, including prescription and over-the-counter (OTC) medications and herbal remedies. The information is documented in the provider’s medication profile; - The registered nurse performs a comprehensive drug regimen review of the patient’s current medications/herbal remedies during each comprehensive assessment. This information is documented in the comprehensive assessment or visit notes/memos; - Any questions or concerns about the patient’s current medications and herbal remedies are directed to the ordering physician; - The list of current medications is incorporated into the plan of care; - The patient’s medications are reviewed and assessed during each skilled visit; and - Any changes to the medications or changes in the patient’s response to the medications are conveyed to the ordering physician and documented in the medical record. RECORD/PATIENT #2: Review of the clinical record showed that the patient's medication list dated 11/27/2023, included the medication Tylenol (a mild pain medication) 500 mg one tablet every six hours as needed. Observation on 11/28/2023 beginning at 9:25 AM, during the patient's home visit, showed the patient reported taking the following medications that were not included on the medication list: - Tylenol 500 mg two tablets every six hours as needed for pain; - Senekot (a medication for constipation) 8.6 mg two tablets as needed- can take up to four tablets per day and used "a few days ago;" - Visine eye drops (used for red or itching eyes) one or two drops as needed four times per day and used "every now and then;" and - The nurse applied Vanicream (an over-the-counter lotion for dry skin) to his/her legs before re-applying tubigrips (a stocking that provides support and compression) to the legs and the patient stated "I use the lotion everyday." RECORD/PATIENT #1: Observation and interview on 11/27/2023 beginning at 1:55 PM, during the patient’s home visit, showed the following medication discrepancies with the provider’s medication profile: - The medication profile showed an order for albuterol 2.5 milligrams (mg) / 3 milliliters (mL) 0.083% inhalation solution, inhale 3 mL by nebulizer two times a day PRN (Pro re nata – commonly used to mean as needed or as the situation arises) for wheezing. The patient stated that he/she did not have a nebulizer machine and was not taking this medication; - The medication profile showed an order for alprazolam 1 mg every eight hours. The medication was not in the home and the patient stated that he/she does not take this medication; - The medication profile showed an order for baclofen 5 mg, one tablet three times a day (TID). The medication in the patient’s home showed a bottle dated 11/14/2023 for baclofen 10 mg TID. The order date on the bottle was 08/30/2023; - The medication profile showed an order for MiraLax 17 grams (gm) daily PRN constipation. The medication was not in the home and the patient stated that he/she was not taking the medication; - The medication profile showed odansetron 4 mg every six hours PRN for nausea. The medication was not in the home and the patient stated that he/she was not taking the medication; - The medication profile showed oxycodone 5 mg, take one every six hours PRN pain. The medication was not in the home and the patient stated that he/she was not taking it; - Docusate sodium 50 mg / sennosides 8.6 mg was found with the patient’s medications and the patient stated he/she took it PRN. The medication was not listed on the patient’s profile; - Extra strength acetaminophen 500 mg was found with the patient’s medications and the patient stated that he/she took two every morning and evening. The medication was not listed on the patient’s profile; - Melatonin 5 mg was found with the patient’s medications and the patient stated that he/she took it daily at bedtime. The medication was not listed on the patient’s profile; and - Vitamin B12 2500 micrograms (mcg) was found with the patient’s medications and the patient stated that he/she took one every morning. The medication was not listed on the patient’s profile. During an interview immediately following the home visit, the quality assurance performance improvement (QAPI) nurse stated that there is usually a form in the admission packet that asks if there were any medication changes and there is a prompt on the tablet that encourages the clinician to ask the patient whether there were any medication changes. He/she would have to look at the policy to see how often the clinician was supposed to physically look at the patient’s medication bottles. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 11/14/2023 with a primary diagnosis of unspecified encephalopathy. The patient was discharged on from a skilled nursing facility (SNF) to the assisted-living facility (ALF) that serves as the patient’s permanent residence on 11/10/2023. Review of the initial assessment, dated 11/14/2023, showed in part, the following: - The patient was noted to have dementia; and - The patient had a memory deficit and impaired decision-making. Review of the provider’s medication profile showed the following discrepancies with the assisted living’s medication record: - The provider’s medication profile showed an order for estradiol 0.1 milligram/gram (mg/gm) vaginal cream, apply 1 gm intravaginally three times a week. The ALF medication record showed the dosage as 0.5 gm vaginally three times a week; - The provider’s medication profile showed an order for mirtazapine 7.5 mg, take two tablets one time a day at bedtime. The ALF medication record showed the dosage as 7.5 mg take one tablet one time a day; - The ALF medication record showed the patient uses Aspercreme with aloe 10% (trolamine salicylate), apply to affected areas topically PRN. The provider’s medication profile failed to include this medication. During the home visit, the certified occupational therapy assistant (COTA) asked the patient if there had been any medication changes. The patient stated that there had not been any changes. The COTA failed to confirm this statement with the ALF. During an interview on 11/30/2023 at 1:00 PM, the clinical manager stated that the clinicians do a full medication reconciliation with each comprehensive assessment and they ask the patient about medication changes at every visit. If medications are kept and passed by the ALF staff, he/she would expect the nurse to ask the ALF medication aide if there had been any changes.

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 home health provider failed to: - Ensure that each patient received an individualized plan of care that includes all elements (Refer to G574); - Ensure that all orders were transcribed and added to the patient’s medical record (Refer to G584); - Ensure that the physician was alerted to changes in the patient’s condition and/or that changes were communicated that might alter the plan of care (Refer to G590); and - Ensure that a visit schedule was available to the patient or caregiver (Refer to G614). The cumulative effect of these deficient practices have the potential to affect the care and services for all the provider’s patients.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to provide an individualized plan of care that included, all pertinent diagnosis, all medications and treatments, and patient specific interventions and goals in three of five records reviewed (Records/Patients #2, #4 and #5). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the home health provider’s policy titled, “Care Planning and Coordination,” revised 11/2013, showed in part: - The purpose was to plan and provide individualized care and/or services appropriate to the goals and needs of patients serviced by the provider; - An individualized plan of care (POC) is developed by the provider’s registered nurse or licensed nurse for each patient based upon an assessment that reflects the patient’s identified problems and needs, consistent with physician or licensed independent practitioner’s orders or prescriptions in accordance with applicable laws and regulations; and - The plan of care includes dates of onset of problems/needs based upon assessment data and physician orders, measurable objective goal statements, interventions to address the identified patient needs, measurable patient outcomes. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 08/17/2023. Review of the plan of care (POC) dated 10/16/2023 to 12/14/2023 included the following interventions: - Agency VS (vital signs) parameters will be assessed each visit and reported to the MD (medical doctor): if diabetic glucose > (greater than) 250 or (Outcome and Assessment Information Set; a standardized data collection tool) showed the brief interview for mental status (BIMS – a tool to determine the individual’s attention, orientation and ability to register and recall new information) score was 15 (A BIMS score of 13 to 15 points indicates cognitive intactness); - OASIS item D0150, patient mood interview showed the clinician documented the patient denied that they had “little interest or pleasure in doing things” and denied “feeling down, depressed, or hopeless”; - The clinician documented the patient answered “never” to “how often do you feel lonely or isolated from those around you”; and - The clinician documented the patient had impaired decision making daily and their actions could have caused injury to self or others or could have jeopardized their personal safety. Review of the POC dated 08/26/2023, showed in part: - An intervention for “all patients with diagnosis of depression or hopelessness – assess mental status and medication compliance each visit. Instruct on signs and symptoms of any adverse reactions and assess efficacy of medications in controlling symptoms. Any verbalization of self-harm or suicidal ideation will be reported to MD (doctor of medicine) immediately and EMS (emergency medical services)/ 911”; - A goal that showed “patient demonstrated compliance with current antidepressant medication therapy and is able to verbalize s/s (signs/symptoms) to report to MD/home health clinician, target date 10/24/2023”; - The patient did not have a diagnosis of depression; and - The patient did not take antidepressants. The provider failed to provide an individualized POC with patient-specific interventions and goals. During an interview on 11/28/2023 at 12:30 PM, the clinical manager stated that the interventions for depression and the antidepressant medication compliance goals are editable and are only used for patients that have a diagnosis of depression. They have the ability to individualize each intervention and goal so the POC is specific to the patient. Findings were reviewed on 11/30/2023 at 1:00 PM with the clinical manager and the quality assurance/performance improvement nurse. Both stated that the physical therapist that performed the initial assessment is usually very thorough so the patient probably had something on his/her BIMS score or something in the assessment that triggered those POC interventions and goals. Both stated that, after reviewing the initial assessment, they could not find any documentation that would explain why the interventions and goals for depression were placed on the POC.

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on policy review, record review and interview, the home health provider failed to ensure physician orders received verbally or by telephone were signed, dated, timed and documented in the clinical record and that verbal orders were authenticated and dated by the physician in two of five records reviewed (Records/Patients #3 and #5). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the home health provider’s policy titled, “Care Planning and Coordination,” revised 11/2013, showed in part: - An individualized plan of care (POC) is developed by the provider’s registered nurse (RN) for each patient based upon an assessment that reflects the patient’s identified problems and needs, consistent with physician or licensed independent practitioner’s orders or prescriptions in accordance with applicable laws and regulations; and - The POC includes the list of dates of onset of problems/needs based upon assessment data and physician orders and interventions to address the identified patient needs. Review of the home health provider’s policy titled, “Care Plan Implementation,” revised 11/2013, showed in part: - The home health provides care, treatment and/or services consistent with the type and frequency identified and documented in the POC; and - The home health provides care, treatment and/or services for each patient according to accepted professional standards and applicable laws and regulations. RECORD/PATIENT #3: Review of the clinical record showed, in part, the following: - A referral, dated 11/09/2023, that showed orders for skilled nursing (SN) to assess and evaluate; - The initial assessment performed by the RN, dated 11/14/2023, that showed the patient had a left forehead laceration that was scabbed over with bruising surrounding the wound and an intervention to leave open to air and monitor for signs and symptoms of infection. Skilled nurse was to perform the assessment one to two times weekly with skilled nurse visits; - The POC, dated 11/14/2023, that showed an order for Skilled nursing to assess and evaluate, with an effective date of 11/9/2023, and an intervention for SN to perform wound care one to two times weekly with skilled nurse visit (order does not specify the SN visit duration); - A communication note, dated 11/15/2023, showed the RN documented receipt of a telephone call from the primary physician’s office that “Dr. (doctor) ok with plan of care and frequency for nursing one to two times a week for a few weeks;” - A transcribed verbal order, dated 11/20/2023, that showed SN to visit one time a week for two weeks and the start date was 11/26/2023; and - The record failed to contain physician orders for the SN visits, with the visit frequency and duration, previously documented as received by the RN in the 11/15/2023 communication note. No further visits were made by the SN after the initial assessment visit on 11/14/2023. RECORD/PATIENT #5: Review of the POC, dated 08/26/2023, showed in part: - A primary diagnosis of hypertensive heart disease (changes in the heart and arteries as a result of chronic blood pressure elevation) with congestive heart failure (CHF- a decrease in the ability of the heart to pump blood) and chronic kidney disease (CKD – a chronic disease of the kidneys usually resulting in kidney failure); - An order that showed vital signs will be assessed each visit and reported to physician if temperature is greater than 100.4 degrees Fahrenheit, heart rate greater than 100 or less than 60, blood pressure (BP) greater than 180/100 or less than 100/60, respirations greater than 24 or less than 12, Oxygen saturations less than 90 percent, blood glucose greater than 250 or less than 80 and “weights – if 3-5 lbs (three to five pounds) weekly or greater than 2-3 lbs (two to three pounds) in 24 hrs (hours)”; and - The patient’s medications included furosemide (a diuretic used to remove excess fluid from the body) 40 milligrams (mg), potassium chloride (a mineral supplement used to treat or prevent low potassium in the blood) 20 milliequivalents (mEq) daily and metoprolol succinate ER (extended release) (used to treat high blood pressure, chest pain and CHF) 25 mg daily. Review of the physical therapy visit note, dated 09/06/2023, showed in part: - The patient had a resting blood pressure of 106/62; - The physical therapy assistant (PTA) documented the patient became dizzy with walking and needed to sit down; - The patient's BP was 78/40 and re-assessed at 80/54 approximately 20 minutes later; and - The PTA documented that he/she made the family (spouse and daughter) aware of the low blood pressure and the daughter reported the patient had an appointment with the cardiologist later that day and she would inform the doctor of the BP readings. Review of the SN visit note, dated 09/07/2023, showed in part: - Medication interventions performed this visit: “Dc (discontinue])metoprolol and aspirin (named physician) on 09/96”; and - A narrative note that stated “medication profile updated and poc update, pt (patient) seen (named physician) cardiology dc aspirin and metoprolol, limit salt 1500 mg daily, limit fluid 2L (two liters) daily, pt verbal understanding”. Review of the physician orders showed the SN failed to document the orders, obtained during the 09/07/2023 visit, for physician authentication and signature. During an interview on 11/30/2023 at 1:00 PM, the clinical manager stated that the SN visits and the sodium and fluid restriction were on the care plan updates but were not generated as orders to be signed by the physician. He/she would expect the nurse to have transcribed the telephone orders or orders found during a home visit when they were received.

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 and interview, the home health provider failed to notify the physician of a 21 pound weight loss from 08/26/2023 to 09/13/2023, on a patient with a diagnosis of congestive heart failure (CHF; a decrease in the ability of the heart to pump blood) and also was on a diuretic (used to remove excess fluid) and an antihypertensive (used to lower blood pressure) in one of five records reviewed (Record/Patient #5), the provider failed to alert the physician of weight changes in one record reviewed (Record/Patient #2), and the provider failed to notify the physician of missed scheduled visits in four of five records reviewed (Records/Patients #2, #3, #4, and #5). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the home health provider’s policy titled, “Care Planning and Coordination,” revised 11/2013, showed in part: - An individualized plan of care (POC) is developed by the provider’s registered nurse or licensed nurse for each patient based upon an assessment that reflects the patient’s identified problems and needs, consistent with physician or licensed independent practitioner’s orders or prescriptions in accordance with applicable laws and regulations; and - The physician is contacted as necessary and appropriate with reports of changes in the patient’s clinical status and/or needs, and for necessary orders and/or prescriptions. RECORD/PATIENT #3: Review of the clinical record showed a referral for home health services with orders for physical therapy (PT) to assess and evaluate. Review of the initial assessment, dated 11/14/2023, showed in part: - The patient required substantial/maximum assistance with transfers to and from bed to chair (item GG0170-E on the Outcome and Assessment Information Set, OASIS); - The patient required partial to moderate assistance with walking distances of 50 feet with two turns and 150 feet once standing (OASIS item GG0170-J,K); - The patient was dependent in his/her ability to go up and down a curb or up and one step (OASIS item GG0170-M); - The patient was dependent in his/her ability to bend/stoop from a standing position to pick up a small object from the floor (OASIS item GG0170-P); and - The patient had a history of falls within the last three months and had a fall risk assessment score of nine (a score of four or more is considered at risk for falling). Review of the PT evaluation, dated 11/16/2023, showed the PT recommended continued skilled PT services one time a week for eight weeks. Review of the physician orders show the home health provider failed to notify the physician of the patient’s assessed need for further PT services and failed to obtain orders for further treatment. During an interview on 11/30/2023, at 1:00 PM, the clinical manager stated that an order for further PT visits was not obtained because they did not want to overwhelm the patient by having too many people going into see the patient. They did not contact the physician and ask for an order to delay the PT visits because they discussed the patient and decided to not do additional PT visits. They did not think they needed to get an order to do that. RECORD/PATIENT #5: Review of the referral for home health services, dated 08/24/2023, showed an order for PT to assess and evaluate the patient. Review of the physician orders showed an order dated 09/05/2023 for PT two times a week for one week then one time a week for six weeks to start 9/5/2023. Review of the physical therapy assistant’s (PTA) visit note, dated 09/15/2023, showed the patient requested to hold PT services until after he/she was seen on 09/27/2023 by an orthopedic physician. The patient reported having too much knee pain to participate in therapy. The note failed to include documentation that the physician was notified of the missed visit or of the patient’s request to hold PT. During an interview on 11/30/2023 at 1:00 PM, the clinical manager stated that they generate a missed visit communication in their electronic medical record software and it automatically notifies the physician of the missed visit but he/she could not provide any evidence to show the physician was notified. He/she stated that once the missed visit note is generated, you cannot get back into it. Review of the initial assessment, dated 08/26/2023, showed in part: - The patient’s height was six feet tall and the patient’s weight was 200 pounds; - The patient had 1+ edema (swelling) to both feet; and - The patient was assessed to fatigue easily and had dyspnea (shortness of breath) on exertion. Review of the POC, dated 08/26/2023, showed, in part: - The patient was 96 years old and lived at home with the assistance of a caregiver; - A primary diagnosis of hypertensive heart disease (changes in the heart and arteries as a result of chronic blood pressure elevation) with congestive heart failure (CHF- a decrease in the ability of the heart to pump blood) and chronic kidney disease (CKD – a chronic disease of the kidneys usually resulting in kidney failure). The patient also had type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar); - An order that showed vital signs will be assessed each visit and reported to physician if temperature is greater than 100.4 degrees Fahrenheit, heart rate greater than 100 or less than 60, blood pressure (BP) greater than 180/100 or less than 100/60, respirations greater than 24 or less than 12, Oxygen saturations less than 90 percent, blood glucose greater than 250 or less than 80 and “weights – if 3-5 lbs (three to five pounds) weekly or greater than 2-3 lbs (two to three pounds) in 24 hrs (hours)”; and - The patient’s medications included furosemide (a diuretic used to remove excess fluid from the body) 40 milligrams (mg), potassium chloride (a mineral supplement used to treat or prevent low potassium in the blood) 20 milliequivalents (mEq) daily and metoprolol succinate ER (extended release) (used to treat high blood pressure, chest pain and CHF) 25 mg daily. Review of the skilled nursing (SN) visit note, dated 08/29/2023, showed, in part: - The patient’s weight was 195 pounds (a five pound weight loss in three days); - The patient had dyspnea on exertion, lungs were clear, no documentation of edema; - Under the heading of “Visit Plan- Contacts / Phone Calls” the SN documented “physician” and “supervisor” were contacted; and - The SN failed to document in the note what was discussed with the physician. Review of two communication notes, both dated 08/29/2023, showed: - At 2:38 PM, the SN spoke with someone at the primary care physician’s (PCP) office and documented that it was okay for the SN visits and the POC (the SN failed to document that the PCP was notified of the weight loss); and - At 2:46 PM the SN entered a narrative note regarding the patient’s wound and need for wound care. The note failed to contain any documentation that the physician was notified of the patient’s weight loss. Review of the SN visit note, dated 09/01/2023, showed in part: - The patient’s weight was 192 pounds (a three pound weight loss in three days and an eight pound loss in six days); - Lungs were clear, no cough noted; and - The SN failed to notify the physician of the weight loss. Review of the physical therapy visit note, dated 09/06/2023, showed in part: - The patient had a resting blood pressure of 106/62; - The patient became dizzy with walking and needed to sit down; - BP was 78/40 and reassessed at 80/54 approximately 20 minutes later; - The patient informed the PTA that he/she did not take his/her morning medications (which included the furosemide and the metoprolol succinate ER); - The PTA requested that the patient take his/her medications and the patient took them; - The family (spouse and daughter) were made aware of the low blood pressure and the daughter reported the patient had an appointment with the cardiologist later that day and she would inform the doctor of the BP readings; - The daughter was comfortable with monitoring the patient’s symptoms and did not feel the need to contact the patient’s PCP; - The PTA failed to notify the physician of the patient’s low BP; - The PTA failed to notify the supervising PT of the patient’s low BP. Review of the SN visit note, dated 09/07/2023, showed in part: - The patient’s weight was 188 pounds (down four pounds in 6 days); - Lungs were clear and dyspnea was noted on exertion; - Medication interventions performed this visit: “Dc (discontinue) metoprolol and aspirin (named doctor) on 09/96”; - A narrative note that stated “medication profile updated and poc update, pt (patient) seen (named doctor) cardiology dc aspirin and metoprolol, limit salt 1500 mg daily, limit fluid 2L (two liters) daily, pt verbal understanding”; and - The SN failed to notify the physician of the weight loss. Review of the SN visit note, dated 9/13/2023, showed in part: - The patient’s weight was 179 pounds (down 9 pounds in a week) - The SN summarized the weight loss as 21 pounds in three weeks; - Lungs were clear, no cough and dyspnea on exertion was noted; and - The SN failed to notify the physician of the weight loss. Review of the clinical record showed no laboratory orders or results. Review of the document titled “Agency Transfer Summary,” dated 09/18/2023, showed “per patient daughter reporting, patient was admitted to (named hospital) for kidney issues related to Lasix (furosemide) therapy.” During an interview on 11/28/2023 at 12:30 PM, the clinical manager stated that the parameters listed in the POC carry over onto each visit note and when the clinician marks the intervention completed, that means they notified the physician of any abnormalities. He/she was unable to provide any documentation that the physician was notified of the patient’s weight loss. During a telephone interview on 11/29/2023 at 10:28 AM, the patient’s PCP staff stated that they had no record of communication from the home health provider on 9/1/2023, 9/6/2023, 9/07/2023, or 9/13/2023 nor did they see any notes in their system close to those dates and they have nothing documented about the patient’s weight loss. There was a call from the provider’s nurse on 08/29/2023 but that was about a wound. The PCP staff was also able to view the cardiologist’s notes because they are in the same medical group and did not see any notes regarding communication from the provider about weight loss. The patient was admitted to the hospital from the emergency room on 09/17/2023 with acute kidney injury. During an interview on 11/29/2023 at 2:20 PM, the clinical manager stated the parameters listed in the patient’s POC regarding weight would refer to either a weight gain or a weight loss. During the interview, the surveyors requested to interview the PTA that provided the patient’s treatment on 09/06/2023 and the clinical manager informed the surveyors that the PTA was no longer employed with the provider. On 11/30/2023 at approximately 2:00 PM, findings were reviewed with the clinical manager, the quality assurance/performance improvement nurse and the administrator (the administrator joined via telephone) and no further documentation to show the physician was notified of the weight loss was provided. RECORD/PATIENT #2: Review of the clinical record showed that the patient was admitted to home health services on 08/17/2023 with a diagnosis of heart failure (a chronic disease in which the heart doesn’t pump blood as it should) and chronic kidney disease stage 3 (a chronic disease of the kidney that leads to renal failure). Review of the POC dated 10/16/2023 to 12/14/2023, showed the following: - Agency VS [vital signs] parameters will be assessed each visit and reported to the MD [medical doctor]: weights if 3-5 lbs [pounds] weekly or greater than 2-3 lbs [pounds] in 24 hours; and - Skilled nursing visits were ordered for two times per week for one week during the week of 10/16/2023 and ending on: 10/21/2023. Review of a skilled nurse (SN) visit dated 10/17/2023 showed a weight of “245 lbs [pounds] 0 oz [ounces] -3 lbs 0 oz (7 days)” and the record failed to show a notification to the physician of the weight loss; Review of a communication note dated 10/19/2023 showed that the sn called the patient for an update related to leg wounds and spoke to the patient’s caregiver. The caregiver stated that a second visit for 10/20/2023 was not needed and the record failed to show that the physician was notified of a missed visit; Review of a SN visit dated 10/31/2023 showed a weight of “250 lbs 0 oz +5 lbs 0 oz (8 days)” and the record failed to show a notification to the physician of the weight gain; Review of a SN visit dated 11/14/2023 showed a weight of “252 lbs 0 oz +2 lbs 0 oz (7days)” and the record failed to show a notification to the physician of the weight gain; and Review of a SN visit dated 11/21/2023 showed a weight of “240 lbs 0 oz -12 lbs 0 oz (7 days)” and the record failed to show a notification to the physician of the weight loss. RECORD/PATIENT #4: Review of the clinical record showed that the patient was admitted to home health services on 10/16/2023 with a diagnosis of type 2 diabetes with diabetic polyneuropathy (a group of diseases that results in too much sugar in the blood complicated by multiple peripheral nerves that malfunction) and a history of falls. Review of the POC dated 10/16/2023 to 12/14/2023 showed the following: - Skilled nursing visits were ordered for one time per week for one week during the week of 10/18/2023 and ending on: 10/21/2023; - Skilled nursing visits were ordered for one time per week for two weeks during the week of 10/20/23 and ending on: 10/28/2023; - Physical therapy (PT) visits were ordered for one time per week for two weeks during the week of 10/29/2023 and ending on: 11/11/2023; and - A physician’s order dated 11/08/2023 showed an order for PT visits one time a week for four weeks with a start date of 11/08/2023 and end date of 12/2/2023. Review of a SN visit note dated 10/20/2023 showed that the patient refused the visit due to having too many other appointments scheduled that day and the record failed to show that the physician was notified of the missed visit; and Review of the PT notes showed no visits were done the week of 11/05/2023 to 11/11/2023 and the week of 11/19/2023 and 11/25/2023 and the record failed to show that the physician was notified of the missed visits. During an interview on 11/30/2023 at approximately 11:00 AM the missed therapy visits were requested and the provider failed to provide any notes related to the missed visits. *****During an interview on 12/01/2023 beginning at 1:00 PM, the clinical manager and the QAPI nurse showed this surveyor in the compu

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, record review, observation, and interview the home health provider failed to ensure that a visit schedule was available to the patient and caregiver in one of three home visits conducted (Record/Patient #2). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Care Plan Implementation,” revised 01/2023, showed that the “agency provides care, treatment and/or services consistent with the type and frequency identified and documented in the plan of care and on the days and at the times scheduled with the patient/family/caregiver.” RECORD/PATIENT #2: Review of the clinical record showed that the patient was admitted to home health services on 08/17/2023. Observation on 11/28/2023 beginning at 9:25 AM, during the patient’s home visit, showed that the patient’s home health folder contained visit schedules for August and September. The provider failed to provide visit schedules for October and November to the patient and/or caregiver. During an interview on 11/30/2023 beginning at 1:00 PM, the clinical manager stated that he/she would expect a visit schedule to be in the patient folder.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on policy review, employee file review, and interview the home health provider failed to ensure that one of four employee files reviewed contained infection control training on orientation (E-2). This deficient practice has the potential to affect all patients served by the provider. Findings included: A policy was requested on 11/29/2023 regarding infection control education and a policy for “Hand Hygiene” was provided. Review of the policy, “Hand Hygiene,” dated 08/2023, showed in part, that “all agency employees, including contracted personnel, receive education regarding hand hygiene, including advantages and disadvantages of various hand cleaning methods, during orientation and at least annually thereafter.” E-2: Review of the employee file showed that E-2 was hired on 03/13/2023. Review of the employee’s training hours showed that the employee completed a training titled “Bag Technique in the Home,” on 04/30/2023. The provider failed to ensure that hand hygiene or any other infection control education was provided during orientation. During an interview on 11/29/2023 at 4:25 PM, the human resources representative stated, “the employees have one year to complete all of the trainings except required courses like Dementia training.”

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on policy review, record review, observation, and interview the home health provider failed to ensure that the plan of care (POC) was followed in one of five full records reviewed (Record/Patient #2). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Care Plan Implementation,” reviewed 01/2023, showed in part, “agency provides care, treatment and/or services consistent with the type and frequency identified and documented in the plan of care and on the day and at the times scheduled with the patient/family/caregiver.” RECORD/PATIENT #2: Review of the clinical record showed: - A physician’s order was obtained on 10/31/2023 for the following: * “Perform wound care/dressing change: left frontal leg popped blister, clean with soap and water, pat dry, apply adhesive bordered foam dressing (an island type dressing that is highly absorbant) to wound, cover with tubigrip (a stocking used to provide firm support and compression to an affected area) size E toe top to knee bend, change tubigrip daily on am off pm, change dressing 2 (two) times weekly and as needed for soilage or dislodgement, SN (skilled nurse) to change 1 (one) time weekly with SNV (skilled nurse visit), pt/cg (patient/caregiver) to perform weekly and as needed in absence of SN (skilled nurse); and * “Perform wound care/dressing change: right frontal leg popped blister, clean with soap and water, pat dry, apply adhesive bordered foam dressing to wound, cover with tubigrip size E toe top to knee bend, change tubigrip daily on am off pm, change dressing 2 (two) times weekly and as needed for soilage or dislodgement, SN (skilled nurse) to change 1 (one) time weekly with SNV (skilled nurse visit), pt/cg (patient/caregiver) to perform weekly and as needed in absence of SN (skilled nurse).” - Review of a SN visit dated 11/14/2023, showed that the left leg shin/blister was healed and the treatment continued for the right leg/shin blister; - Review of a SN visit dated 11/21/2023, showed that the right anterior leg shin/blister was healed; and - The clinical record failed to contain orders to discontinue treatments to the right or left leg. Observation on 11/28/2023 beginning at 9:25 AM, during the patient’s home visit, showed that the registered nurse (RN) removed the patient’s tubigrip stockings from both legs, inspected both legs for open areas, applied moisturizing lotion to both legs, allowed the lotion to soak into the skin, and then reapplied the tubigrip stockings to both legs. The RN failed to clean the areas with soap and water, pat dry, and apply bordered foam dressings as ordered. During an interview on 11/30/2023 beginning at 1:00 PM, the clinical manager stated that he/she would expect the POC to be followed.

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 non-compliance with one Condition of Participation §484.60 Care Planning, Coordination of Services, and Quality Care, the provider 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 on 12/04/2025.

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 nationally-recognized standards, policy review, employee file review, and interview the home health provider failed to ensure that one out of four employee files contained the family care safety registry (FCSR) check as required and that one out of four employee files contained the employee disqualification list (EDL) check as required (E-1 and E-3). This deficient practice has the potential to affect all patients served by the provider. Findings included: Section 192.2495 RSMo, requires employees of licensed home health agencies under contract with the Missouri Department of Health and Senior Services, to register with the Family Care Safety Registry regardless of hire date. This section also requires home health agencies to conduct criminal background screenings by checking the Family Care Safety Registry. Review of Section 192.2495.6, RSMo: “A provider is guilty of a class A misdemeanor if the provider knowingly hires or retains a person to have contact with patients or residents and the person has been found guilty in this state or any other state or has been found guilty of a crime, which if committed in Missouri would be a class A or B felony violation of chapter 565, 566 or 569, or any violation of subsection 3 of section 198.070 or section 568.020.” Review of Section 192.2495.7, RSMo (effective August 28, 2018): “Any in-home services provider agency or home health agency shall be guilty of a class A misdemeanor if such agency knowingly employs a person to provide in-home services or home health services to any in-home services client or home health patient and such person either refuses to register with the family care safety registry or if such person: (1) Has any of the disqualifying factors listed in subsection 6 of this section; (2) Has been found guilty of or pleaded guilty or nolo contendere to any felony offense under chapter 195 or 579; (3) Has been found guilty of or pleaded guilty or nolo contendere to any felony offense under section 568.045, 568.050, 568.060, 568.175, 570.023, 570.025, 570.030, 570.040 as it existed prior to January 1, 2017, 570.090, 570.145, 570.223, 575.230, or 576.080; (4) Has been found guilty of or pleaded guilty or nolo contendere to a violation of section 577.010 or 577.012 and who is alleged and found by the court to be an aggravated or chronic offender under section 577.023; (5) Has been found guilty of or pleaded guilty or nolo contendere to any offense requiring registration under section 589.400; (6) Is listed on the department of health and senior services employee disqualification list under section 192.2490; (7) Is listed on the department of mental health employee disqualification registry under section 630.170; or (8) Has a finding on the child abuse and neglect registry under sections 210.109 to 210.183.” Review of Section 192.2490.12 RSMo: "No person, corporation, organization, or association who received the employee disqualification list under subdivisions (1) to (7) of subsection 11 of this section shall knowingly employ any person who is on the employee disqualification list." Review of the provider’s undated policy titled, “Background Checks,” showed in part, that: - The FCSR should be checked before offer of employment, after offer of employment, and annually; and - The EDL should be checked before an offer of employment and quarterly. E-1: Review of the employee files showed that E-1 was hired on 02/25/2022 and the FCSR was checked on 01/12/2023. The provider failed to ensure that the FCSR was checked prior to the employee’s first contact with patients. During an interview on 11/29/2023 at 4:25 PM, with the human resources representative, further information for the employee’s FCSR prior to contact with patients was requested. During an interview on 11/30/2023 at 10:00 AM, the human resources representative stated that no other information was available for the employee’s FCSR check. E-3: Review of the employee files showed that E-3 was hired on 06/27/2023 and the EDL was checked on 07/17/2023. The provider failed to ensure that the EDL was checked prior to hire. During an interview on 11/30/2023 beginning at 1:00 PM, the clinical manager stated that he/she would expect the FCSR and the EDL to be checked correctly and according to the regulations.

The Emergency Preparedness regulations were reviewed as part of the Medicare certification survey completed on 03/17//2021. During the survey it was determined St. Andrews and Bethesda Home Health. is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Agencies.

A complaint investigation (MO00181127) was completed on 03/17/2021. The complaint was substantiated. One or more of the allegations reported are verified and a condition was identified at: - 484.58 Condition of Participation: Discharge Planning. An extended survey for Medicare certification for St. Andrews and Bethesda Home Health was completed on 03/17/2021. The agency had 104 current patients. During the extended survey, an additional condition was identified at: -484.60 Care Planning, coordination of services, and quality of care. A COVID-19 Focused Infection Control survey was completed on 03/17/2021. One deficiency was identified related to the Infection Control survey.

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 review of the agency's current patient rights information, home visit observation, and interview, the agency failed to ensure each patient received written information related to the contact information for the home health agency administrator in order to receive complaints in two (Record/Patient #4 and #5) of three applicable home visit records. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities for all patients served by the agency. Findings included: Review of the agency's Explanation of Patient Rights which was included in the admission booklet left in the patient's home at time of admission showed: - The patient and representative (if any) have the right to be informed of the patient's rights in a language and manner the individual understands and the agency must protect and promote these rights; and - The agency must provide the patient and legal representative (if any) the following information during the initial evaluation visit in advance of furnishing care to the patient: * Contact information for the agency administrator, including the administrator's name, business address, and business phone number in order to receive complaints. RECORD/PATIENT #4: During a home visit observation on 03/16/2021 at 11:30 AM, the admission packet of information which should include the administrator's name and contact number, was not found in the home of Patient #4. RECORD/PATIENT #5: During a home visit observation on 03/16/2021 at 10:18 AM, the admission packet of information which should include the administrator's name and contact number, was not found in the home of Patient #5. During an interview on 03/17/2021 at 10:30 AM, the administrator stated that he/she had only been in the position since January, 2021 and his/her name was not printed in the folder. His/her name should be listed in the folder for patients in order to receive complaints.

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 the agency's current patient rights information, record review, and interview, the agency failed to provide proper written notice in advance of the agency reducing skilled nursing visits, for one (Record/Patient #1) of five 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 Home Health Admission Booklet, revised 09/2019 showed: - If you are an Original Medicare (fee for service) beneficiary and your plan of care changes, including a decrease in frequency of home health visits, you or your authorized representative will be issued and asked to sign and date a Home Health Change of Care Notice (HHCCN) (a form to notify original Medicare beneficiaries receiving home health care benefits of plan of care changes. Home health agencies are required to provide written notification to beneficiaries before reducing an item and/or service). RECORD/PATIENT #1: Review of the clinical record review showed: - The plan of care (POC) dated 01/25/2021 to 03/25/2021 showed skilled nursing visits three times a week for three weeks beginning on 01/25/2021 and ending 02/13/2021; - A verbal order, dated 02/04/2021 showed to discontinue skilled nursing visits three times a week effective 02/04/2021 and to start skilled nursing visits two times a week for two weeks on 02/04/2021; 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 03/09/2021 at 12:05 PM, the director of home health stated the agency did not provide the patient written notice in advance of the agency reducing skilled nursing visits. No further information was provided.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to document the existence of a complaint and resolution of complaint, for one (Record/Patient #1) of five 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, "Patient Concerns/Grievances," last revised 11/2016 showed, in part, but not limited to: - To support and respect patients' rights to have concerns/grievances about their care and/or services heard, reviewed and if possible, resolved, thereby promoting positive patient outcomes; - To promote positive patient outcomes and meet patient/family needs for quality care and services; - To provide an efficient and effective complaint resolution process; - It is the responsibility of the director of home health, director of senior support Solutions to understand and enforce this policy. It is the responsibility of all the agency employees to abide by this policy; - All patient serviced by the agency are informed verbally and in writing prior to the initiation of service/care of their rights to participate in decisions regarding their care, treatment and/or services, to voice grievances/complaints and to recommend changes in policies, care and services without coercion, discrimination, reprisal and/or unreasonable interruption in services; - Any complaint received from a patient that cannot be resolved "On-the-Spot" by staff members, will be forwarded in writing to the director/administrator or his/her designee; - The director is responsible for acknowledging receipt of all patient complaints and for giving feedback to the patient and the administrator or Vice President; - The director retains final responsibility for the resolution of all patient complaints; - A record of the complaint, investigation, follow-up action and response to the patient will be documented, using the Patient Complaint Form and will be retained by the director in a Patient Complaint file for a minimum of three years following the last date of a written decision provided to the complainant. This form is to be initiated by the person receiving the complaint; - The investigation shall be completed within 5 days unless circumstances prevent finalization within that time period. - The patient/family shall be notified verbally and in writing of the delay; and - A copy of the complaint log and investigations will be forwarded to corporate compliance. Record/Patient #1: Review of the communication note dated 01/31/2021 at 11:20 PM showed the on-call Registered Nurse (RN) documented the patient had a "litany" of complaints with the agency's service. The RN informed the home health supervisor of the call. During an interview on 03/08/2021 at 11:35 AM, the clinical manager said: - There were no patient complaints/grievances in the past six months; - The only patient who had problems was patient #1 and he/she was discharged from services; - The patient had his/her skilled nursing visits decreased from three to two visits a week and the patient wanted visits three times a week; and - The patient went with another agency who could see him/her three times a week. During an interview on 03/10/2021 at 10:26 AM, the clinical manager said he/she was the on-call supervisor 01/31/2021 and the on-call RN notified him/her of the following patient complaints; - The time of visits and staff not coming at the time the patient wanted; - The type of supplies the agency was using; - Discharge; - Skilled nurse visits decreased from three times a week to two times a week; and - The clinical manager said he/she should have filled out a grievance report. Review of an e-mail from the Director of home health, dated 3/10/2021 at 3:08 PM, showed if there is a grievance there are many options available to the patients, including but not limited to, contacting the clinical director, director of nursing or the civil rights coordinator. There was no additional information.

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 an accurate medication reconciliation was completed in, but not limited to, two (Records/Patients #4 and #5) of three home visits performed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, "Medication Management-Patient Information," dated 05/2017 showed: - During the initial assessment visit, the registered nurse/therapist generates a list of the current medications, including prescription and over the counter (OTC) medications and herbal remedies and should include the name of the medication/herbal remedy, whether the current dosage is new, changed or long standing, classification of the medication or herbal remedy, and dosage route and frequency of administration of the medication or herbal remedy. RECORD/PATIENT #4: Review of an agency Communication Note dated 03/11/2021 showed: - A Registered nurse (RN) recorded that the patient had two new medications that needed to be verified by the physician; - He/she called the physician to verify Hydralazine 10 mg three times a day (TID) and hold if blood pressure is less than 170, and Folic Acid daily; - The physician's nurse sent this information to the physician as high priority and to the patient's pharmacy; - The RN informed the caregiver of the above; and - No orders were found in the patient's record for Hydralazine, or Folic Acid. Review of the agency's Medication Profile printed on 03/15/2021 for Patient #4 showed: - Acetaminophen (Tylenol for pain or fever) 650 milligrams (mg) extended release tablets, take two every eight hours as needed (PRN) for pain; - Allopurinol (used to treat gout, swelling and inflammation of joints) 100 mg, one tablet daily; - Atorvastatin (lowers cholesterol levels) 40 mg, one daily; - Carvedilol (blood pressure medication) 6/25 mg, one two times a day (BID); - Duloxetine (an antidepressant) 60 mg delay release capsule, one daily; - Finasteride (blocks the male hormone that causes the prostate gland to become enlarged) 5 mg, one tablet daily; - Furosemide (rids the body of excess fluid) 40 mg, two tablets BID; - Lisinopril (blood pressure medication) 20 mg, one tablet BID; - Sodium bicarbonate (an antacid and lowers the acidity of the blood or urine), 650 mg, on tablet daily; and - Tamsulosin (used to treat symptoms of an enlarged prostate), 0.4 mg, take one capsule daily. Review of a medication sheet from a previous hospital admission for the patient which the family member followed to set up the patient's medications for administration showed: - Acetaminophen 500 mg, take 1,000 mg every six hours PRN; - Aspirin (low dose to help prevent heart attack or stroke) 81 mg, one tablet daily; - Emollient combination cream (to treat dry skin) to bilateral lower extremities; - Folic Acid (a Vitamin B supplement) 1 mg, take one daily; - Hydralazine (a blood pressure medication) 10 mg, three times a day (TID), hold if blood pressure less than 170; and - Thiamine (a vitamin supplement to prevent a Vitamin B1 deficiency) 100 mg one daily. Review of the bottles of medications the patient stated he/she currently took but were not included on the agency's medication profile sheet showed: - Super Vitamin B complex (a supplement) daily; - Aloe Vista ointment for his/her legs; - Aspirin 81 mg, daily; - Lisinopril was not found in the current box of medications; - A bottle of Tylenol with Codeine which the patient stated he/she did not take regularly; and - All other medications listed on the agency list were in the box of bottled medications the patient was taking. RECORD/PATIENT #5: Review of the patient's medication bottles, kept in a locked box in the home, during a home visit observation on 03/16/2021 (Tuesday) at 10:30 AM showed: - A red box with a lock and key; - An empty Sunday through Saturday pill box was sitting on top of all of the patient's medications; -OTC Calcium/Magnesium/Zinc (supplement), no dosage or frequency on the bottle or agency list; - OTC Biactin plus Keratin 10,000 u, no dosage or frequency on the bottle or agency list; - Tylenol (Acetaminophen) 500 mg tablets, no dosage or frequency on the bottle or agency list; - OTC Melatonin (a natural sleep medication), no dosage or frequency on the bottle or agency list; - OTC Womens formula vitamin supplement, no dosage or frequency; - OTC Multivitamin for women; - Tramadol (narcotic pain reliever) 50 mg, one every six hours PRN; - Furosemide (rids body of excess fluid) 20 mg, one tablet daily; - Fish oil (supplement) 1200 mg, no dosage or frequency on the bottle; - Vitamin D3 (supplement) no dosage or frequency on the bottle; - Senna-S (stool softener/laxative) 50 mg/8.6 mg, no dosage or frequency on the bottle; - Diltazem HCL Extended Release (used to treat irregular heart beat) 300 mg per day; - Warfarin (blood thinner) 2.5 mg tablets, 1 1/2 tablet daily; and - Warfarin 5 mg tablets, one by mouth every day except 1/2 tablet on Wednesdays. The patient's medication list in the home included (no date noted): - Acetaminophen 325 mg tablets two tablets every six hours; - Calcium 500 mg (a supplement) plus Vitamin D (400 international units (IU)), chew one tablet daily; - Diltiazem (used to treat heart arrhythmia's) 300 mg every 24 hours, one daily; - Fish oil, 1200 mg oral capsule, one daily; - Multi-day plus mineral multivitamin, one daily; - Furosemide 20 mg, take two tablets daily; - Senna S (a stool softener/laxative) 50 mg/8.6 mg tablets, take one or two tablets daily; - Tramadol (a narcotic pain medication) 50 mg, one tablet every eight hours PRN; - Vitamin D3 2000 (IU), one capsule daily; - Coumadin (a blood thinner to prevent stroke) 2 mg tablets, take 3 mg daily- 1.5 tablets on Tuesday, Thursday, and Saturday; and - Coumadin 2 mg tablets, take 4 mg daily- two tablets on Sunday, Monday, Wednesday, and Friday. Review of the agency's Medication Profile dated 03/15/2021 for the patient showed: - Acetaminophen 325 mg tablets two tablets every six hours; - Calcium 500 mg (a supplement) plus Vitamin D (400 international units (IU)), chew one tablet daily; - Diltiazem 300 mg every 24 hours, one daily; - Fish oil, 1200 mg oral capsule, one daily; - Multi-day plus mineral multivitamin, one daily; - Furosemide 20 mg, take two tablets daily; - Senna S (a stool softener/laxative) 50 mg/8.6 mg tablets, take one or two tablets daily; - Tramadol (a narcotic pain medication) 50 mg, one tablet every eight hours PRN; - Vitamin D3 2000 (IU), one capsule daily; - Coumadin (a blood thinner to prevent stroke) 2 mg tablets, take 3 mg daily- 1.5 tablets on Tuesday, Thursday, and Saturday; - Coumadin 2 mg tablets, take 4 mg daily- two tablets on Sunday, Monday, Wednesday, and Friday; - Dosages for Tramadol and Furosemide did not match the patient's medication list; - Did not include Calcium/Magnesium/Zinc tablets, Biactin plus Keratin 10,000 units, Melatonin 3 mg, Tylenol 500 mg tablets. During an interview on 03/16/2021 at 10:30 AM, the patient stated he/she did not know what medications he/she took; all his/her medications were locked up. During an interview on 03/16/2021 at 4:15 PM, the clinical manager stated: - Medication reconciliation is performed when the patient is admitted; - Staff separate medications not being taken from medications the patient is taking; - Staff look at hospital or rehab lists of medications when the patient comes home; - Staff calls the physician to verify what medications the patient should be taking; - Staff writes the order for medications the patient was to take and these medications are written on the plan of care (POC); - Any change in dosage ends the prior orders and another order starts; - At admission, all medications have to be clarified; - Medications are reconciled at every visit and the staff should ask if there had been any changes or if there was/were any physician visits; - An updated list of medications is taken to the home each visit; - A RN from another company would be setting up the patient's medications today and was issued a new agency list this morning (03/16/2021); - The Warfarin change will be added on the patient list when the RN makes a visit today to set up his/her medications; - The orders for the change in Warfarin were received on 03/08/2021 and a visit was not scheduled until 03/16/2021, so that is when the order will be added to the patient's medication list in the home; - The patient is confused and that is why the medications needed to be locked in a box and a nurse needed to set up the medications; and - The bottles of medication not listed are medications the patients do not currently take.

Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This CONDITION is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to meet the requirements of 484.58 Condition of Participation: Discharge Planning, when the agency: - Failed to implement an effective discharge planning process (G562); and - Failed to document/send all necessary medical information to the receiving facility or health care practitioner to ensure the safe and effective transition of care (G564). The cumulative effect of these deficient practices has the potential to affect the care of all patients served by the agency.

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on the agency's current patient rights information, clinical record review, and interviews, the agency failed to implement an effective discharge planning process in one (Record/Patient #1) of two closed records reviewed. This deficient practice has the potential to affect all patients admitted to the home care agency. Findings included: Review of the agency's Home Health Admission Booklet, revised 09/2019 showed, in part, the following: - Discharge planning will begin when you are admitted to the agency based on the findings of the comprehensive assessment performed at admission; - Any revisions related to plans for your discharge will be communicated to you, all physicians issuing orders for our agency plan of care, your primary care practitioner and any other health care professionals who will be providing care and services to you after discharge from our agency; - You will be given advance notice of your discharge or transfer to another agency in accordance with applicable state regulations; - Following your discharge or transfer, we will send a transfer summary within the timeframe specified by federal regulations to your primary care practitioner or other health care professional who will be providing care and services to you after discharge or transfer from or agency; - The summary may include, but will not be limited to, a list of your current medications and information necessary for the patient's continued care, including pain management; and - If you elect to transfer to another agency and were under an established plan of care, Medicare requires us to coordinate the transfer. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 11/26/2020 with a primary diagnosis of diabetes mellitus type 2 (a chronic condition that affects the way the body processes blood sugar that can cause lower extremity nerve damage and poor circulation) with foot ulcer. He/she also has pertinent diagnoses of non-pressure chronic ulcer of left heel and mid foot limited to breakdown of skin (a full thickness wound below the ankle in a diabetic patient), type II diabetes mellitus with hyperglycemia (high blood sugars), diabetic polyneuropathy (neurological disorder of all the nerves in the body), and morbid (severe) obesity. Review of the emergency room documentation dated 02/14/2021 at 2:45 AM showed: - The patient presented to the emergency department due to pain in his/her right foot secondary to diabetic foot ulcer; - There was a round ulcer on the right heal medially (toward the middle) that measured five centimeter (cm) round with some dead tissue, surrounded by 3 to 4 cm of erythematous (redness) area; and - The foot x-ray showed a superficial skin infection with some pocketed pus. Review of the hospital discharge summary dated 02/15/2021 showed: - The patient was admitted on 02/14/2021 and discharged on 02/15/2021; - History of present illness: Morbidly obese male was admitted through the emergency room with worsening right heel pain; - The patient had a diabetic ulcer on the right heel: Commenced by emergency department on IV (intravenous) vancomycin (treats infections) which was continued, IV antibiotics changed to oral on discharge; - Doxycycline 100 mg twice daily for seven days; - Blood sugars remain high persistently and discharge instructions were given to check blood sugars three times daily with meals and at night; and - The patient was to follow up with his primary care physician in one week and an endocrinologist in 4 weeks. Review of the hospital non-physician progress note dated 02/15/2021 at 3:58 PM showed the patient was discharged home via ambulance. Review of a skilled nursing visit note dated 02/16/2021 at 10:33 AM showed the case manager did not do a skilled nurse visit because the patient was not discharged from the hospital and the visit was rescheduled for another day. The agency supervisor was notified. (The hospital notes showed the patient was discharged from the hospital on 02/15/2021.) Review of the discharge OASIS (outcome and information assessment set) assessment dated 02/18/2021 showed: - The patient was being discharged from the agency; - The patient decided to go with a new home health agency; - The discharge reason was the patient requested discharge/refused service; - He/she was educated multiple times about wound care and he/she had supplies to meet his/her needs until he/she gets seen again; - The patient used the hospital emergency department without hospital admission; - Reason for emergent care was marked other than above reasons; - The patient's right foot heel diabetic ulcer wound bed was non-granulating, the wound bed was red, wound edges macerated and there was a large amount of yellow-green drainage with a mild odor; - The wound measured length 5 cm by 3 cm width; - Glucose monitoring as needed, blood sugar result was 382 (a blood sugar less than 140 mg/dl (milligrams per deciliter) is normal (The record failed to include the order to show blood sugars changed to three times daily and at night per the hospital discharge record); - The medication profile was reviewed and there was no new or changed medications (The record failed to include the order for Doxycycline 100 mg twice daily per the hospital discharge record); and - The physician was contacted 02/18/2021 (The record failed to include documentation to show that the physician was notified of the discharge). The facility failed to provide a discharge planning process with the patient's physician, wound care clinic, and the new agency. During a telephone interview, on 3/09/2021 at 3:02 PM, the case manager said he/she discharged the patient from the agency on 02/18/2021. The patient's wound was worse. Another agency had accepted the patient and the patient had several people who could help him with his/her dressing change. He/she did not communicate with the new agency. During an interview on 03/11/2021 at 1:16 PM, the office manager for the patient's primary care physician said they were not aware the patient had been discharged from the home health agency. The patient depends on and needs home care services. During an interview on 03/10/2021 at 10:26 AM, the clinical manager said the agency sent the physician a discharge summary, notified the wound clinic and told them to send information to the new agency. The agency did not send the new agency information because the patient was a new referral for them and the patient wasn't transitioning to a higher skill level. The hospital sent information to the new agency. The agency kept the patient until the day before the new agency started care. The patient did have concerns about his/her discharge and they had a conversation of his/her wound and care of the wound. They would not have discharged him/her with a open complicated wound without the new agency starting care the next day after discharge. During a telephone interview on 03/10/2021 at 9:15 AM, the Director of Nursing from the new agency said the agency admitted the patient on 02/22/2021. They did not receive any patient information from the home health agency that discharged the patient. During a telephone interview 03/11/2021 at 3:09 PM, the clinical manager said there was no discharge order. The agency sends the discharge summary to the physician and that shows services ended. During an interview on 03/17/2021 at 10:30 AM and 10:54 AM, the clinical manager said discharge planning starts at the start of care. They decreased the patient's visits gradually to prepare for discharge. Before the discharge assessment the patient's wound stayed pretty consistent and two visits a week was sufficient. If the patient had a significant change they would have not discharged the patient. The patient requested to go to the new agency. He/she was educated multiple times about wound care. His/her physician was notified of the discharge. They sent a discharge summary to the physician but had no way to show if he/she received the information due to a software issue. During a telephone interview on 03/18/2021 at 3:45 PM, the patient said the agency came to discharge him/her and he/she did not want to be discharged, and the agency insisted. The case manager said this would be his/her last visit. He/she had no family or friends who could do his/her dressing changes and he/she was unable to do the wound care. He/she wanted the agency to stay until the new home health agency could start care.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to send: - All necessary medical information pertaining to the patients' current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility in three (Record/Patient #3, #4 and #6) of three records reviewed that had a transfer to the hospital; and - All necessary medical information pertaining to the patients' current course of illness and treatment, post-discharge goals of care, and treatment preferences,to the primary care practitioner or other health care professional who will be responsible for providing care to the patient after discharge in one (Record/Patient #1) of two closed records reviewed. This deficient practice has the potential to affect the post transfer and discharge needs for all agency patients. Findings included: Review of the agency's policy titled, "Discharge Summary, Final Visit Note", dated 11/13 showed, in part: - Purpose: Provide current patient discharge/transfer information and comply with state and federal requirements; - Responsibility: It is the responsibility of the Director of Home Health to understand and enforce this policy. It is the responsibility of all agency employees to abide by this policy; - Policy: There will be a discharge summary form completed for each patient discharged or transferred from agency services; - The discharge summary will be available to the patient's physician, upon request; - Procedure: Skilled nursing, physical therapy, occupational therapy will each make a discharge visit; - The case manager will complete the form to discharge the patient from service; - The summary of interventions and patient/caregiver goals addressed on the last/transfer visit is recorded; - A summary of the patient's problems, staff interventions and the patient/family response is recorded in the next section, along with the following: - The dates covered by the summary; - Information from all disciplines that provided care during the certification period; - All new diagnoses and/or exacerbation of diagnosis; - Medication changes, new medications; - All pertinent lab results; - Vital sign-weight, blood sugar ranges; - Explanation of changes in frequency of visits; - All hospitalizations, emergency/urgent care; - All new or changed physician's orders; - Physician appointments and the outcome; - All significant clinical findings, symptoms, changes in the client's status; - Safety concerns that support continued care; - Wound appearance, measurements, progress toward healing; - Progress towards therapy goals; and - Psychosocial or environmental changes. RECORD/PATIENT #1: Review of the plan of care dated 01/25/2021 to 03/25/2021 showed: - Primary diagnosis of diabetes mellitus type 2 (a chronic condition that affects the way the body processes blood sugar that can cause lower extremity nerve damage and poor circulation) with foot ulcer; - Other pertinent diagnoses included non-pressure chronic ulcer of left heel and mid foot limited to breakdown of skin (a full thickness wound below the ankle in a diabetic patient), type II diabetes mellitus with hyperglycemia (high blood sugars), diabetic polyneuropathy (neurological disorder of all the nerves in the body), and morbid (severe) obesity; - Assess blood sugar monitoring and results and notify physician as indicated (no parameters or how often to monitor blood sugars documented); - Skilled nursing to perform wound care/dressing change to right heel diabetic ulcer; cleanse with Dakins 1/4 strength (used to prevent and treat infection), apply gentamycin ointment 1% (used to treat infections) to wound bed, cover with aquacel ag (hydrofiber dressing to help manage moderate to highly exudating/draining wound), then ABD (absorbent dressing) or foam dressing. Secure with roll gauze and tape three times weekly; - Skilled nursing three times a week for three weeks, beginning week on 01/25/2021 and ending 02/13/2021; and - Perform wound care /dressing change (did not specify area) on Monday, Wednesday and Friday. Review a verbal order dated 02/04/2021 at 1:58 PM, showed skilled nursing two times a week for two weeks effective 02/08/2021 through 02/20/2021. A discharge summary dated 02/21/2021 showed: - Skilled nursing discharged the patient from service on 02/18/2021; - Status of patient goals/outcomes: Goals not met- noncompliance; - The summary: Patient wanted to be discharged. He/she was educated on how to take care of his/her wound and also had plenty of supplies for his/her wound care; - Post discharge goals: For his/her wound to right heel to continue to heal; - Treatment preferences: None; - There was no evidence the summary was sent to the new home health agency that continued the patient's care, or the patient's wound care physician; and - The discharge summary failed to contain all necessary medical information pertaining to the patients' current course of illness and treatment, post-discharge goals of care, and treatment preferences, and was not sent to the new home health agency. During an interview on 03/09/2021 at 12:36 PM the director of home health said: - The wound care center forwarded information to the new agency; - The agency did not send information to the new agency; - The discharge summary was sent to the patient's physician; and - The new agency did not request any of the patient's information. During an interview on 03/10/2021 at 10:26 AM, the clinical manager said: - The patient was discharged and transitioned to the new agency; - The agency sent the patient's physician the discharge summary and notified the wound clinic and told the wound clinic to send the patient's information to the new agency; - The patient recently was on observation at the hospital and the hospital sent the patient's observation records to the new agency; and - There was no discharge summary sent to the new agency because they are not required to send a discharge summary when the patient is not transitioning to a higher level of care like a skilled nursing facility. RECORD/PATIENT #3: Review of the plan of care (POC) dated 02/11/2021 through 04/11/2021 showed: - Primary diagnosis: Acute cystitis (a sudden inflammation of the urinary bladder); and - Other diagnoses included but not limited to: Escherichia coli (bacteria) as the cause of the disease, other pulmonary embolism (one or more arteries of the lungs become blocked by a blood clot), acute embolism (clot of blood) and thrombosis (blood clot in a deep vein), unspecified dementia and chronic obstructive pulmonary disease (COPD) and chronic diastolic (congestive) heart failure. Review of a verbal order dated 02/26/2021 showed, perform wound care/dressing change: skilled nursing/caregiver to clean unstageable pressure ulcer (full thickness tissue loss in which the actual depth is completely obscured by slough (yellow, tan, gray, green, brown) and/or eschar (tan, brown or black) in the wound bed) to left posterior (behind) thigh above knee with wound cleanser, apply aqua cell silver (a wound dressing) and cover with foam twice a week and as needed if bandage becomes soiled. Review of the Agency Transfer Summary dated 03/07/2021 showed: - Transferred to hospital on 03/07/2021 for decline in health; - Primary diagnosis: Pressure ulcer of other site unstageable; - Summary: Patient went to hospital due to change in condition. Daughter had a hard time waking her up and she was very weak; - Status of Patient Goals/Outcomes: Goals unchanged; - Post Discharge Goals: Hospital; - Treatment Preferences: None; and - The transfer summary did not contain all necessary medical information pertaining to the patients' current course of illness and treatment, post-discharge goals of care, and treatment preferences, and failed to be sent to the hospital. During an interview on 03/16/2021 at 3:05 PM, the clinical manager said the transfer summary was sent on 03/09/2021. The fax showed the transfer summary was sent to the physician and not the hospital. When a patient transfers you don't fill out the condition of the patient, this is only done when a patient is discharged off of service. During an interview on 03/16 at 3:05 PM the clinical records coordinator said the transfer summary was sent to the physician. RECORD/PATIENT #4: Review of the plan of care (POC) dated 01/16/2021 through 03/16/2021 showed: - Primary diagnosis: Generalized osteoarthritis; - Other diagnoses included but not limited to: Chronic pain syndrome, heart failure, gout (swelling, and painful joints), heart disease, and benign prostatic hyperplasia (enlarged prostate gland that can block the flow of urine from the bladder); - History of falls; - Physical therapy (PT) assess and evaluation, start of care (SOC) and occupational therapy (OT) assessment starting 01/15/2021 through 01/22/2021; and - PT 2 times per week for 3 weeks (2w3) starting week of 01/07/2021 ending 02/06/2021. Review of the Agency Transfer Summary dated 03/03/2021 showed: - Transferred to hospital on 02/26/2021; - Physician contacted on 02/28/2021; - Diagnoses included but not limited to: Generalized osteoarthritis, chronic pain syndrome, heart failure, gout (swelling, and painful joints), heart disease, and benign prostatic hyperplasia (enlarged prostate gland that can block the flow of urine from the bladder); history of falls; - Summary: Patient found on the floor and has been there all night per the spouse; unknown amount of time; - Status of Patient Goals/Outcomes: Goals unchanged; - Post Discharge Goals: Same as before; - Treatment Preferences: None; - Discipline Orders: PT 2 times per week for 3 weeks (2w3), PT 1w3, skilled nursing (SN) assess and evaluate, PT to assess and evaluate for PT and OT; and - The transfer summary did not contain all necessary medical information pertaining to the patients' current course of illness and treatment, post-discharge goals of care, and treatment preferences. The agency failed to send the information to the hospital. RECORD/PATIENT #6: Review of the POC dated 01/28/2021 through 03/28/2021 showed: - Primary diagnosis: Pressure ulcer (PU) to left buttock, unstageable (full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed); - Other pertinent diagnoses, but not limited to: Congestive heart failure (fluid around the heart), Type 2 diabetes (elevated blood sugar levels), chronic kidney disease, peripheral vascular disease (poor circulation to lower extremities), severe intellectual disabilities, wound care PU left buttock; - SN to assess and evaluate, SOC week of 01/27/2021 through 02/01/2021; - SN 1w1, 3w3 beginning week of 01/28/2021 through 02/27/2021; and - Medical social worker (MSW) to assess and evaluate 01/27/2021 through 02/27/2021. Review of the Agency Transfer Summary dated 02/09/2021 showed: - Diagnoses included but not limited to: Pressure ulcer (PU) to left buttock, unstageable (full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed); congestive heart failure (fluid around the heart), Type 2 diabetes (elevated blood sugar levels), chronic kidney disease, peripheral vascular disease (poor circulation to lower extremities), severe intellectual disabilities, wound care PU left buttock; - Transfer date: 02/05/2021; - Transfer to: Hospital; - Reason for Agency Transfer: Decline in health; - Physician contacted: 02/05/2021; - Discharge condition: Sent to hospital for bradycardia (slowed heart rate) with rising of blood pressure and respiration rate; - Patient/Family Discharge Instructions: Left blank; - Status of Patient Goals/Outcomes: Goals partially met: Pt/family to resume care; - No summary documented; - Post Discharge Goals: Return to home with caregiver, possibly after rehabilitation; - Treatment Preferences: Receiving stabilization at hospital; and - Discipline Orders: MSW to assess and evaluate, SN to assess and evaluate at SOC; - The transfer summary did not contain all necessary medical information pertaining to the patients' current course of illness and treatment, post-discharge goals of care, and treatment preferences. The agency failed to send the summary to the hospital. Review of the Agency Discharge Summary dated 03/04/2021 showed: - Diagnoses included but not limited to: Pressure ulcer (PU) to left buttock, unstageable (full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed); congestive heart failure (fluid around the heart), Type 2 diabetes (elevated blood sugar levels), chronic kidney disease, peripheral vascular disease (poor circulation to lower extremities), severe intellectual disabilities, wound care PU left buttock; - Discharge date: 02/06/2021; - Reason for agency discharge: Discharge/transfer to another type of care institution not defined elsewhere in code list; - Physician contacted: 02/06/2021; - Discharge condition left blank; - Patient/family Discharge Instructions left blank; - Status of Patient Goals/Outcomes: Goals not met: unattainable; - Summary: Determined that patient will be discharged to a higher level of care after hospitalization due to lack of appropriate caregiving; - Post Discharge Goals: Long term care; - Treatment Preferences: NA; - Discipline Orders: MSW assess and evaluate, SN assess and evaluate, SOC; During an interview on 03/17/2021 at 10:30 AM, the clinical manager stated: - The discharge and transfer summaries are not comprehensive because each discipline sends their own when they discharge/transfer the patient.

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, and interview, the agency failed to meet the requirements for 484.60-Condition of Participation: Care Planning, coordination of services, and quality of care, when the agency failed to: - Provide an individualized plan of care that included all required elements (G574); - Promptly alert the relevant physician of changes in the patient's condition that may suggest a need to alter the plan of care (G590); - Assure communication with all physicians involved in the plan of care (G602); - Provide a visit schedule, including frequency of visits to the patient (G614); and The cumulative effect of these deficient practices has the potential to affect the care of all patients served by the agency.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interviews, the agency failed to ensure that each patients' written individualized care plan included all the required elements in, but not limited to, one (Record/Patient #3) of five records reviewed. This deficient practice has the potential to impact the care provided to all agency patients. Finding included: Review of the agency policy titled, "Plan of Care" revised/updated 04/2020, showed in part: - All plan of care (POC) will be updated and revised for all status changes the patient may have; - All POC will be updated to reflect any new or change physician's orders to assure correct treatment according to the POC; and - All verbal and written orders will be entered into the POC and interventions and goals updated to reflect the changes. RECORD/PATIENT #3: Review of the start of care comprehensive assessment dated 02/11/2021 at 1:00 PM showed: - Assess cardiovascular status for signs and symptoms of cardiac complications; - Heart rhythm irregular; - Problems: Edema and fatigues easily; and - Right and left ankle and pedal 1+ mild pitting edema (a system used to determine the severity of the edema on a scale from +1 to +4. It is assessed by applying pressure on the affected area and then measuring the depth of the depression and how long it last), slight indentation, no perceptible swelling. Review of the Skilled Nursing Visit Notes showed: - On 02/16/2021 at 2:19 PM, a telephone visit showed the patient had a deep vein thrombosis (DVT) (a blood clot in a deep vein) in his/her right lower leg and he/she only complains when he/she is ambulatory and he/she says it is from the edema. He/she has edema to bilateral lower extremities to include both feet; - On 02/18/2021 at 9:59 AM, right and left ankle and pedal 2+ moderate pitting edema, indentation subsides rapidly, and Clinical findings: CHF, DVT, hypertension; - On 02/25/2021 at 11:51 AM, right calf edema 2+ moderate pitting, indentation subsides rapidly, left calf 3+ deep pitting, indentation remains for a short time and appears swollen, right and left ankle 3+ deep pitting edema, remains for a short time and appears swollen and Clinical findings: CHF and hypertension. Review of the plan of care dated 02/11/2021 through 04/11/2021 showed the plan: - Failed to address DVT interventions; - Failed to address congestive heart failure; - Failed to address edema and intervention; - Failed to address weights, frequency, parameters and when to call the physician; - Failed to address vital signs parameters and when to call the physician During an interview on 03/16/2021 at 2:30 PM, the clinical manager said the patient/caregiver had current knowledge of CHF so he/she knew the information on edema. When edema increases staff should ask questions like did the patient take his/her diuretic or have an increase in fluids. The patient took a diuretic on Monday and Thursday's and that's the intervention for the edema. The assessment and interventions are on the plan of care. No further information was provided.

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, and interview, the agency failed to alert the physician to changes in the patient's condition or needs that may suggest that the plan of care (POC) should be altered in, but not limited to, two (Record/Patient #1 and #3) of six records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, "Care Planning and Coordination," revised 11/2013 showed, in part: - Purpose: To plan and provide individualized care and/or services appropriate to the goals and needs of patients; - The physician is contacted as necessary and appropriate with reports of changes in the patient's clinical status and/or needs, and for necessary orders and/or prescriptions. RECORD/PATIENT #1: Review of the plan of care dated 01/25/2021 to 03/25/2021 showed: - Primary diagnosis of diabetes mellitus type 2 (a chronic condition that affects the way the body processes blood sugar that can cause lower extremity nerve damage and poor circulation) with foot ulcer; - Other pertinent diagnoses included non-pressure chronic ulcer of left heel and mid foot limited to breakdown of skin (a full thickness wound below the ankle in a diabetic patient), type II diabetes mellitus with hyperglycemia (high blood sugars), diabetic polyneuropathy (neurological disorder of all the nerves in the body), and morbid (severe) obesity; and - Skilled nursing to perform wound care/dressing change to right heel diabetic ulcer; cleanse with Dakin's 1/4 strength (used to prevent and treat infection), apply gentamycin ointment 1% (used to treat infections) to wound bed, cover with aquacel ag (hydrofiber dressing to help manage moderate to highly exudating wound), then abd or foam dressing. Secure with roll gauze and tape. Review of skilled nurse visit notes showed: - On 01/29/2021 at 11:01 AM, the patient's right foot heel/diabetic ulcer wound bed was clean and pink and a small amount of yellow-green drainage. The wound measured length 1.5 centimeters (cm) by width .5 cm and the "wound status improved"; and - On 02/01/2021 at 10:15 AM, the patient's right foot heel/diabetic ulcer wound bed was dry and pink and a small amount of yellow-green drainage. The wound measured 1.5 cm by 1.5 cm and the "wound status improved", the physician was not notified of change of the wound size and drainage; - On 02/05/2021 at 1:45 PM, the patient's right foot heel/diabetic ulcer wound bed was dry and pink and a small amount of yellow-green drainage. The wound measured 1.5 cm by 1.5 cm, the physician was not notified of the wound size and drainage; - On 02/09/2021 at 11:46 AM, the patient's right foot heel/diabetic ulcer wound bed had slough (yellow/white material in the wound bed which consists of dead cells that accumulate in the wound fluid) and color is red, yellow and dusky. There is a scant amount of drainage (no description) and no measurements. The physician was not notified of the wound bed; and - On 02/12/2021 at 12:05 PM, the patient's right foot heel/diabetic ulcer wound bed had slough and granulating (part of the healing process), the bed color is red 20%, yellow 60% and black 20% and there is a small amount of serosanguineous (yellowish fluid with small amounts of blood) drainage with no odor, there was no measurements (no measurement since 02/05/2021). The "wound status improved." The physician was not notified of the wound bed or drainage. Review of the emergency room documentation dated 02/14/2021 at 2:45 AM showed: - The patient presented to the emergency department due to pain in his/her right foot secondary to diabetic foot ulcer; - There was a round ulcer on right heal medially (toward the middle) that measure five centimeter (cm) round with some dead tissue, surrounded by 3 to 4 cm of erythematous (redness) area; and - The foot x-ray showed a superficial skin infection with some pocketed pus. Review of the hospital discharge summary dated 02/15/2021 showed: - The patient was admitted on 02/14/2021 and discharged on 02/15/2021; - History of present illness: Morbidly obese male was admitted through the emergency room with worsening right heel pain; - The patient had a diabetic ulcer on the right heel: Commenced by emergency department on IV (intravenous) vancomycin (treats infections) which was continued, IV antibiotics changed to oral on discharge; and - Doxycycline 100 mg twice daily for seven days. Review of an e-mail received on 03/10/2021 at 3:08 PM showed the director of home health had responded to the surveyor request for a wound care policy. He/she wrote all patients are admitted with an individual plan of care and treatments will reflect that on the plan of care, established by each physician. Parameters on wounds and when to notify a physician are based on an individualized basis and best practice. During an interview on 03/09/2021 at 12:36 PM, the clinical manager said on 02/05/2021 he/she notified the physician the patient's visits could be decreased from three times a week to two times a week to prep the patient for discharge and did not recall notifying the physician of the wound size. Wounds are measured once a week and there was no documentation. If the wound does not improve within a two weeks the physician is notified unless the wound deteriorates more, example would be if it developed an odor. During an interview on 03/09/2021 at 12:36 PM, the director of home health said the patient's wound went up in size but was still improving so there was no need to notify the physician, the size could have increased due to granulation. It is best practice to measure wounds weekly and it's not policy. RECORD/PATIENT #3: Review of the clinical record showed: - The patient's start of care was 02/11/2021; - Primary diagnosis: Acute cystitis (a sudden inflammation of the urinary bladder); and - Other diagnoses included but not limited to: Escherichia coli (bacteria) as the cause of the disease, other pulmonary embolism (one or more arteries of the lungs become blocked by a blood clot), acute embolism (clot of blood) and thrombosis (blood clot in a deep vein), unspecified dementia and chronic obstructive pulmonary disease (COPD) and chronic diastolic (congestive) heart failure (chronic progressive condition that affect the pumping power of your heart muscle). Review of the start of care comprehensive assessment dated 02/11/2021 at 1:00 PM showed: - Activity intolerance; - Assess cardiovascular status for signs and symptoms of cardiac complications; - Heart rhythm irregular; - Problems: Edema and fatigues easily; and - Right and left ankle and pedal 1+ mild pitting edema (a system used to determine the severity of the edema on a scale from +1 to +4. It is assessed by applying pressure on the affected area and then measuring the depth of the depression and how long it last), slight indentation, no perceptible swelling. Review of the Skilled Nursing Visit Notes showed the following: - On 02/16/2021 at 2:19 PM, a telephone visit showed the patient had a deep vein thrombosis (DVT) (a blood clot in a deep vein) in his/her right lower leg and he/she only complains when he/she is ambulatory and he/she says it is from the edema. He/she has edema to bilateral lower extremities to include both feet; - On 02/18/2021 at 9:59 AM, right and left ankle and pedal 2+ moderate pitting edema, indentation subsides rapidly, and clinical findings: CHF, DVT, hypertension and Lung sounds clear; - On 02/25/2021 at 11:51 AM, right calf edema 2+ moderate pitting, indentation subsides rapidly, left calf 3+ deep pitting, indentation remains for a short time and appears swollen, right and left ankle 3+ deep pitting edema, remains for a short time and appears swollen; Clinical findings: CHF and hypertension; Breath sounds clear; and The nurse saw the patient for discharge but did not end up discharging due to the patient developing a left thigh pressure ulcer. (There was no documentation to show the physician was notified of the increased edema); - On 03/02/2021, no assessment of the lower extremities ; and - On 03/05/2021, no assessment of the lower extremities. During interview on 03/16/2021 at 2:30 PM, the clinical manager said the patient had a significant change in condition from original care which changed the focus. The agency was no longer seeing the patient for COPD or edema and the focus becomes the wound. He/she would expect the nurse to assess the patient's increased edema by asking questions like: is the patient taking diuretics and has he/she recently increased fluids. The patient took a diuretic on Monday and Thursday's and that would be an intervention. The physician is notified if the patient needs intervention other than education.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on clinical record review, and interviews the agency failed to assure communication with all physicians involved in the plan of care in one (Record/Patient #1) of six records reviewed. This deficient practice has the potential to affect all patients admitted to the home care agency. RECORD/PATIENT #1: Review of the plan of care dated 01/25/2021 to 03/25/2021 showed: - Primary diagnosis of diabetes mellitus type 2 (a chronic condition that affects the way the body processes blood sugar that can cause lower extremity nerve damage and poor circulation) with foot ulcer; - Other pertinent diagnoses included non-pressure chronic ulcer of left heel and mid foot limited to breakdown of skin (a full thickness wound below the ankle in a diabetic patient), type II diabetes mellitus with hyperglycemia (high blood sugars), diabetic polyneuropathy (neurological disorder of all the nerves in the body), and morbid (severe) obesity; - Skilled nursing to perform wound care/dressing change to right heel diabetic ulcer; cleanse with Dakin's 1/4 strength (used to prevent and treat infection), apply gentamycin ointment 1% (used to treat infections) to wound bed, cover with aquacel ag (hydrofiber dressing to help manage moderate to highly exudating wound), then abd or foam dressing. Secure with roll gauze and tape three times weekly; - Skilled nursing three times a week for three weeks, beginning week on 01/25/2021 and ending 02/13/2021; and - Perform wound care /dressing change (did not specify area) on Monday, Wednesday and Friday. Review of skilled nurse visit notes showed: - On 01/29/2021 at 11:01 AM, the patient's right foot heel/diabetic ulcer wound bed was clean and pink and a small amount of yellow-green drainage. The wound measured length 1.5 centimeters (cm) by width 0.5 cm and staff documented the wound had improved; and - On 02/01/2021 at 10:15 AM, the patient's right foot heel/diabetic ulcer wound bed was dry and pink and a small amount of yellow-green drainage. The wound measured 1.5 cm by 1.5 cm and staff documented "the wound status had improved". The agency failed to document any communication with the physician or wound care clinic of the increase in wound size and drainage. Review of the wound care clinic physician orders details from the patient's visit dated 02/03/2021, showed skilled nursing to continue wound care to patient's right heel ideally every other day or minimum three times per week. Review of a verbal order from the patient's primary care physician dated 02/04/2021 showed skilled nursing two times a week for two weeks, start date 02/08/2021 and end date 02/20/2021. Discontinue skilled nursing three times a week for three weeks effective 02/04/2021. The agency failed to document if they notified the primary care physician of the wound care clinic's physician orders from 02/03/2021 or the increase in wound size. During interview on 03/09/2021 at 12:36 PM, the clinical manager said he/she called the primary care physician on 02/05/2021 to decrease the patient's skilled nurse visits in preparation for the patient's discharge. The wound did not require dressing changes three times a week. There was no documentation to show if the primary care physician was notified of the wound clinics orders or the increase in the wound size. During an interview on 03/11/2021 at 1:16 PM, the primary care physician's office manager said upon the agency's request to decrease home visits the agency did not communicate the orders given from the wound care clinic physician or the wound's increase in size. The agency should get orders from the wound care clinic physician.

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 review of the agency's current patient rights information, home visit observation, clinical record review, and interview, the agency failed to ensure each patient received written information related to visit schedule/instructions, in two (Record #4, and #5) of three applicable home visits. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's Explanation of Patient Rights which was included in the admission booklet left in the patient's home at time of admission showed: - The patient and representative (if any) have the right to be informed of the patient's rights in a language and manner the individual understands and the agency must protect and promote these rights; - The agency must provide the patient and legal representative (if any) the following information during the initial evaluation visit in advance of furnishing care to the patient; and - The patient has the right to participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to the frequency of visits. RECORD/PATIENT #4: Review of the plan of care (POC) dated 01/16/2021 through 03/16/2021 showed that the physician ordered: - Physical therapy (PT) assess and evaluate, start of care (SOC) 01/15/2021; and - PT to assess for occupational therapy (OT) from 01/15/2021 through 01/22/2021; - PT 2 times a week for 3 weeks (2w3), beginning the week of 01/17/2021 and ending 02/06/2021. Review of a verbal order sheet dated 02/04/2021 showed: - PT 1w3 starting 02/07/2021 ending 02/27/2021. Review of a verbal order sheet dated 02/25/2021 showed: - Skilled nursing (SN) to assess and evaluate for pressure injuries to the buttocks starting 02/25/2021; Review of a verbal order sheet dated 03/04/2021 showed: - SN to assess and evaluate for a resumption of care (ROC) starting 03/04/2021 and ending 03/11/2021; - PT to assess and evaluate for a ROC starting 03/05/2021 ending 03/12/2021; and - OT to assess and evaluate for a ROC starting 03/05/2021 ending 03/19/2021. Review of a verbal order sheet dated 03/07/2021 showed: - SN 2w1 starting 03/07/2021 ending 03/13/2021. Review of a verbal order sheet dated 03/08/2021 showed: - PT 1w1, 1w1 starting 03/08/2021 ending 03/16/2021. Review of a verbal order sheet dated 03/10/2021 showed: - SN 2w1 starting 03/14/2021 through 03/26/2021. Review of a verbal order sheet dated 03/10/2021 showed: - OT 1w1 starting 03/10/2021 through 03/13/2021. Review of a verbal order sheet dated 03/10/2021 showed: - OT 1w1 starting 03/14/2021 through 03/16/2021. Review of a verbal order sheet dated 03/15/2021 showed: - PT 1w3 starting 03/17/17/2021 through 04/03/2021. The home visit observation on 03/16/2021 at 11:30 AM showed the admission packet and information provided to patient's included a schedule for recording discipline visits (SN, PT, OT). The schedule was blank, and failed to include any scheduled discipline visits. A large calendar which hung on a closet door that the spouse used to record activities did not show scheduled discipline visits. During an interview on 03/16/2021 at 12:00 PM, Patient #4 stated that the agency staff did not write their visits on a calendar, they just called to let him/her know when they were coming for a visit. The findings were reviewed with the clinical manager on 03/17/2021 at 12:00 PM and he/she said he/she thought the visits were listed on the spouse's large wall calendar and he/she would check it out to be sure. RECORD/PATIENT #5: Review of the POC dated 02/09/2021 through 04/09/2021 showed: - SN to assess and evaluate, SOC 02/08/2021 through 02/13/2021; - SN 1w1 needed or lab work beginning week of 02/14/2021 ending 02/20/2021; and - PT to assess and evaluate for PT and OT starting 02/08/2021 through 02/15/2021. The home visit observation on 03/16/2021 at 10:18 AM showed the admission packet and information provided to patients included a schedule for recording of discipline visits (SN, PT, OT). The schedule was blank and failed to include any scheduled discipline visits. The findings were reviewed with the administrator on 03/17/2021 at 12:00 PM and no further information was provided.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on policy review, observation, and interview, the agency failed to maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the quality of assessment and performance improvement (QAPI) program. This deficient practice has the potential to affect the infection control needs for all patients served by the agency. Findings included: Review of the agency's policy titled, "Quality Assurance and Performance Improvement (QAPI)/Risk Management Program," dated April, 2019 showed: - Purpose: To establish written guidelines regarding a corporate-wide QAPI/Risk Management program; and - The director and senior management are responsible for identifying those internal processes and activities to be measured, assessed, amended if necessary, and monitored for effectiveness. Review of the agency's policy titled, "Infection Control and Prevention," dated June, 2017 showed, but limited to: - Purpose: To assist in providing a high level of patient care by reducing the risk of healthcare associated infections (HAI) for patients, families, staff and volunteers of the agency; - Responsibility: It is the responsibility of the director to understand and assure compliance with this policy and the responsibility of all agency employees to abide by the policy; - The goal of preventing HAIs is an administrative priority for the agency and the HAI Control Plan assists in providing a high level patient care by reducing the ever-present risk of HIAs for patients, families, staff, and volunteers through the following; - Surveillance: Identification of baseline information about the frequency and type of HAIs; investigation as needed; - Prevention: Infection prevention and control policies and procedures are developed using evidence-based national guidelines, expert consensus and a review and evaluation of healthcare literature; procedure review and evaluation; identification of risks for acquiring and spreading of infections based on geographic location, community population served, care, treatment or services provided, analysis of surveillance activities and other infection control data and risks are prioritized and documented; - Clinical controls: Identification of patients/families and/or staff and volunteers with communicable or potentially communicable infections; implementation of appropriate infection control measures; - Performance improvement: Continuous review and evaluation of infection control practices; - Administrative controls: Providing access to information to support infection prevention and control activities; - Goals: Address prioritized risks, infection control management decisions shall be made using data regarding institutional experience/epidemiology, trends in community and institutional HAIs, local, regional and national epidemiology, and emerging infectious disease threats; - Interaction with, and mandatory reporting to the Department of Health shall be performed; - Ensure fiscal and human resources to maintain infection control and occupational health programs that are responsive to emerging needs; - The Infection Control Committee is responsible for infection control activities and is responsible for surveillance, data collection and analysis of infections/communicable diseases; -The Infection Control Committee shall identify problems, opportunities for improvement, actions taken, recommendations and evaluation of previous actions; - The committee shall identify any HAI trends or patterns that occur as well as identify opportunities to improve outcomes in the reduction and control of infections; - Performance improvement: Will review infection control issues monthly and summarize and report their findings quarterly to the governing body; significant findings will be reported to the Performance Improvement Committee; - An evaluation of the organization's function and of the performance improvement process shall be conducted at least on an annual basis and whenever risks significantly change; and - The evaluation shall review prioritized risks, infection prevention and control goals, and implementation of infection control and prevention activities. Review on 03/1/2021 at 10:30 AM of a handwritten list of patient names, type of infections, and treatment/actions by the clinical manager showed no surveillance and evaluation of infections, implementation of infection control, prevention activities or risks; no infections were recorded after 07/15/2020. Review of the Performance Improvement Plan Evaluation dated January, 2021 documented by the agency director showed: - Infection control and prevention as a priority focus area with continued logging system. Review of a computerized list of patients and infections, with agency acquired infection (yes/no) and date resolved was provided by the corporate Vice President on 03/17/2021 at 10:30 AM but no evaluation, implementation of infection control, prevention activities or risks were included. During an interview on 03/17/2021 at 10:30 AM, the director stated: - Infection control is a current performance improvement plan (PIP) that he/she has worked on this since his/her hire in January, 2021; - There have been no incidences of infection that have required a PIP; - Infections are now tracked in the computer system; - The agency provided education for trends and how corrected; and - The method for identifying infections was set up in the computer this morning; it was not to be set up until April, 2021; the agency should have continued the paper tracking until the computer program was set up.

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 the agency's current resident right information, record review, policy review, and interview, the agency failed to ensure: - A completed transfer summary was sent within two business days of an unplanned transfer in two (Record/Patient #4 and #6) of two records reviewed; and - A completed discharge summary was sent to the primary care practitioner or other health care professional who will be responsible for providing care to the patient after discharge within five business days of the patient's discharge in one (Record/Patient #6) of two closed records reviewed. Review of the agency's Home Health Admission Booklet, revised 09/2019 showed: - Following a discharge or transfer from another agency, a discharge or transfer summary will be sent within the timeframe specified by federal regulations to your primary care practitioner or other health care professional who will be providing care and services to you after discharge or transfer from the agency; and - The summary may include, but will not be limited to, a list of your current medications and information necessary for the patient's continued care, including pain management. RECORD/PATIENT #4: Review of the plan of care (POC) dated 01/16/2021 through 03/16/2021 showed: - Primary diagnosis: Generalized osteoarthritis; - Other diagnoses included but not limited to: Chronic pain syndrome, heart failure, gout (swelling, and painful joints), heart disease, and benign prostatic hyperplasia (enlarged prostate gland that can block the flow of urine from the bladder); - History of falls; - Physical therapy (PT) assess and evaluation, start of care (SOC) and occupational therapy (OT) assessment starting 01/15/2021 through 01/22/2021; and - PT 2 times per week for 3 weeks (2w3) starting week of 01/07/2021 ending 02/06/2021. Review of the Agency Transfer Summary dated 03/03/2021 showed: - Transferred to hospital on 02/26/2021; - Physician contacted on 02/28/2021; - Diagnoses included but not limited to: Generalized osteoarthritis, chronic pain syndrome, heart failure, gout (swelling, and painful joints), heart disease, and benign prostatic hyperplasia (enlarged prostate gland that can block the flow of urine from the bladder); history of falls; - Summary: Patient found on the floor and has been there all night per the spouse; unknown amount of time; - Status of Patient Goals/Outcomes: Goals unchanged; - Post Discharge Goals: Same as before; - Treatment Preferences: None; - Discipline Orders: PT 2 times per week for 3 weeks (2w3), PT 1w3, skilled nursing (SN) assess and evaluate, PT to assess and evaluate for PT and OT; - Electronically signed by registered nurse (RN) on 03/03/2021 at 6:47 PM, five days after admission to the hospital. - The transfer summary did not contain a comprehensive assessment of the treatment and services by all disciplines who provided care to the patient; and - No documentation was provided to indicate when the transfer summary was sent to the hospital/healthcare provider or physician caring for the patient. RECORD/PATIENT #6: Review of the POC dated 01/28/2021 through 03/28/2021 showed: - Primary diagnosis: Pressure ulcer (PU) to left buttock, unstageable (full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed); - Other pertinent diagnoses, but not limited to: Congestive heart failure (fluid around the heart), Type 2 diabetes (elevated blood sugar levels), chronic kidney disease, peripheral vascular disease (poor circulation to lower extremities), severe intellectual disabilities, wound care PU left buttock; - SN to assess and evaluate, SOC week of 01/27/2021 through 02/01/2021; - SN 1w1, 3w3 beginning week of 0128/2021 through 02/27/2021; and - Medical social worker (MSW) to assess and evaluate 01/27/2021 through 02/27/2021. Review of the Agency Transfer Summary dated 02/09/2021 showed: - Diagnoses included but not limited to: Pressure ulcer (PU) to left buttock, unstageable (full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed); congestive heart failure (fluid around the heart), Type 2 diabetes (elevated blood sugar levels), chronic kidney disease, peripheral vascular disease (poor circulation to lower extremities), severe intellectual disabilities, wound care PU left buttock; - Transfer date: 02/05/2021; - Transfer to: Hospital; - Reason for Agency Transfer: Decline in health; - Physician contacted: 02/05/2021; - Discharge condition: Sent to hospital for bradycardia (slowed heart rate) with rising of blood pressure and respiration rate; - Patient/Family Discharge Instructions: Left blank; - Status of Patient Goals/Outcomes: Goals partially met: Pt/family to resume care; - No summary documented; - Post Discharge Goals: Return to home with caregiver, possibly after rehabilitation; - Treatment Preferences: Receiving stabilization at hospital; - Discipline Orders: MSW to assess and evaluate, SN to assess and evaluate at SOC; - The transfer summary did not contain a comprehensive assessment of the treatment and services by all disciplines who provided care to the patient; and - Electronically signed by registered nurse (RN) on 02/09/2021 at 8:13 PM; and - No documentation was provided to show when the summary was sent to the admitting hospital/healthcare provider or physician caring for the patient. Review of the Agency Discharge Summary dated 03/04/2021 showed: - Diagnoses included but not limited to: Pressure ulcer (PU) to left buttock, unstageable (full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed); congestive heart failure (fluid around the heart), Type 2 diabetes (elevated blood sugar levels), chronic kidney disease, peripheral vascular disease (poor circulation to lower extremities), severe intellectual disabilities, wound care PU left buttock; - Discharge date: 02/06/2021; - Reason for agency discharge: Discharge/transfer to another type of care institution not defined elsewhere in code list; - Physician contacted: 02/06/2021; - Discharge condition left blank; - Patient/family Discharge Instructions left blank; - Status of Patient Goals/Outcomes: Goals not met: unattainable; - Summary: Determined that patient will be discharged to a higher level of care after hospitalization due to lack of appropriate caregiving; - Post Discharge Goals: Long term care; - Treatment Preferences: NA; - Discipline Orders: MSW assess and evaluate, SN assess and evaluate, SOC; - The summary did not contain a comprehensive assessment of the treatment and services by all disciplines who provided care to the patient; - Electronically signed by clinical manager on 03/04/2021 at 10:53 AM 30 days after the patient was transferred to the hospital; and - No documentation was provided of when the summary was sent to the physician or healthcare provider caring for the patient. During an interview on 03/17/2021 at 10:30 AM, the clinical manager stated: - The transfer summary should be sent within two days of transfer to the accepting healthcare provider; - The discharge summary should be sent within five days of discharge to the patient's physician; and - The patient was admitted to several different healthcare providers after the transfer from the agency on 02/05/21, and that is the reason the discharge summary was not sent to the physician until later.