Every finding on record at Compassionate Care Home Health Agency

The following reflects the findings of the California Department of Public Health during the Complaint Validation Survey on 6/19/24 to 6/25/24. Representing the Department of Public Health: 27390. HFEN During the survey the following Condition of Participation(COP) were reviewed. 484.50 Patient Rights, 484.60 Care Planning, Coordination, Quality of care, 484.65 Quality Assessment /Performance Improvement , 484.75 Skilled Professional Services and 484.80 Home Health Aide Services. Number of Record Review with Home Visit :2 Record Review :2 Total sample size : 4 The facility was found to be in substantial compliance with all Conditions of Participation surveyed.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on interview and record review the agency failed to ensure communication between disciplines was done for one of four sampled patients (Patient 1) when Physical Therapy (PT) 1 did not call Patient 1’s Registered Nurse (RN) 1 to inform RN 1 of Patient 1’s low blood pressure and fatigue during her home visit. This failure resulted in Patient 1 not receiving necessary nursing assessment, intervention and education by RN 1 prior to her next scheduled home visit. Findings: During a review of Patient 1’s “Patient Communication” note, dated 2/25/24, written by PT 1, the note indicated, “Initially, it was difficult to obtain the patient’s blood pressure and it appeared that it may have been 81/64 or 88/64 (normal range 120/80). It was hard to hear the blood pressure. The patient was instructed to drink water and lay down and then it came in at 90/64. The patient reported that he did not feel up for therapy, but he was willing to stand up one time then due to fatigue and pain he was unable to ambulate and required moderate assistance to stand up. The patient was trained regarding what to do if his blood pressure is low and if he felt dizzy, not ambulating but using a wheelchair and the patient was trained how to remove the armrest of the wheelchair and scoot from his couch onto the wheelchair and back again. The patient verbalized understanding of the training provided. A phone call was placed to the doctor’s office and a voicemail message was left regarding the patient’s blood pressure and that the patient has had a decline in his mobility. The patient does not want to continue physical therapy services at this time.” There was no documented evidence that PT 1 notified RN 1(the case manager) regarding the Patient 1’s low blood pressure and fatigue during her visit. During a review of Patient 1’s “Physical Therapy” note, dated 2/26/24, the note indicated Patient 1 was discharged from the therapy per patient/family request. There was no documented evidence that PT 1 informed RN 1 about unexpected discharge from Physical Therapy. During a review of Patient 1’s “Communication Note” dated 3/5/24, the note indicated Patient 1 was hospitalized on 3/5/24 due to sepsis. During a phone interview on 6/20/24 at 3:15 p.m., with PT 1, PT 1 stated she did not call RN 1 about Patient 1’s change of condition she encountered during her home visit. PT 1 stated Patient 1 was alert, oriented and capable of verbalizing his needs without any difficulty. PT 1 stated she did not know Patient 1 had a drainage tube on his abdomen. PT 1 stated she communicated with other disciplines by communication note. PT 1 stated everyone who was assigned to Patient 1’s case had access to read the communication note. PT 1 stated it was not her standard of practice to call case manager directly to notify change of condition. PT 1 stated she always called the physician but not the case manager. PT 1 stated she expected RN 1 to read the communication note. RN 1 was no longer employed with the agency and unable to interview. During an interview on 6/20/24 at 3:53 p.m., with Physical Therapy Assistant (PTA) 1, PTA 1 stated he reported any change of condition to his supervisor by phone call during home visit followed by communication note for record keeping. During an interview on 6/24/24 at 9:15 a.m., with Licensed Vocational Nurse (LVN) 1, LVN 1 stated any change of condition, such as out of the range vital signs, severe pain, or fatigue she called the case manager. LVN 1 stated the communication note was utilized for record keeping but not to replace a call. During an interview on 8/24/24 at 11:30 a.m., with RN 2, RN 2 stated the communication note did not replace the need for a direct phone call. RN 2 stated the agency’s standard of practice was to call the case manager for any change of condition or change of POC. RN 2 stated it was very important to communicate any change of conditions between disciplines to provide patients continuous care and provide the necessary assessment and treatment in timely manner. RN 2 stated the communication note was for tracking and record keeping. During an interview on 6/24/24 at 2:30 p.m., with the Clinical Supervisor (CS), the CS stated she did not know PT 1 did not call to notify RN 1 of Patient 1’s change of condition. The CS stated her expectation was for PT 1 to call RN 1 for Patient 1’s low BP and fatigue during her visit so RN 1 could assess the situation and arrange a visit sooner than scheduled (SN scheduled visit was three days later) if necessary. The CS stated communication note did not replace the call to the case manager. The CS stated when SN was ordered PT must communicate with RN case manager and if no SN was ordered PT must report any medical concerns to the CS. The CS stated she requested the visit note from [Hospital] but could not get the note of Patient 1’s visit to IR to validate the reason for RN 1 not changing the dressing on 2/22/24. The CS stated Patient 1 was able to speak out if RN 1 omitted the dressing change for no reason. During a review of the agency’s Policy and Procedure (P&P) titled “Care/Service Coordination” dated 11/20, the P&P indicated, “… the clinician will be responsible for facilitating communication about changes in the patient’s status among the assigned personnel …” During a review of the agency’s job description for “Physical Therapist”, undated, the job description indicated, “… communicate with other team members, as appropriate, regarding the patient’s plan of care, and updates team members when there are changes ...”

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency ‘s Registered Nurse (RN) 1 failed to provide patient care giver education regarding wound care to the common bile (a liquid made by the liver, helps digest fats) duct drain (allows bile to flow out from a blocked bile duct into a collection bag outside the body) and disease process for one of four sampled patients (Patient 1) when RN 1 did not identify the primary caregiver to educate during the entire certification period (60 days). This failure placed Patient 1 at risk for pain and infection which could prevent Patient 1 from achieving the plan of care (POC-a document that outline the health conditions, specific care needs and current treatments of a patient) due to lack of education to the primary caregiver. Findings: During a review of Patient 1’s POC, dated 1/10/24 to 3/9/24, the POC indicated, “Skilled nursing (SN): 1 visit per week for 9 weeks: SN for wound care to common bile duct drain, disease process education … SN to assess skin for breakdown each visit. SN to instruct on and perform common bile duct dressing change weekly as follows: using sterile technique, remove old dressing, cleanse area with [brand name sterile antiseptic solution], cover site with split drainage sponge and [brand name transparent medical dressing], add securement device as needed.” During a concurrent interview and record review on 6/20/24 at 10 a.m., with the Clinical Supervisor, Patient 1’s skilled nursing visit notes were reviewed. RN 1 performed the initial assessment on 1/10/24. There was no documented evidence that who was Patient 1’s primary caregiver and what education was provided upon her visit. SN visit note dated 1/24/24, 1/31/24, 2/12/24, 2/22/24 and 2/28/24 were reviewed. There was no documented evidence indicating who was the primary caregiver and what education was provided in the visit notes. The CS stated RN 1 should have identified Patient 1’s primary caregiver to educate Patient 1 and the caregiver. The CS stated RN 1 did check marks on each visit indicating she did education but unable to locate narrative documentation to whom and what was taught throughout the entire certification period. The CS stated it was her expectation for RN 1 to assess the availability of caregiver and document the content of education no later than the first week from the start of care. RN 1 was no longer employed with the agency and unable to interview. During a review of the agency’s job description for “Registered Nurse”, undated, the job description indicated, "... Provides education and information to the patient and/or family members as appropriate to their plan of care …”

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency‘s Registered Nurse (RN) 1 failed to prepare the clinical record accurately to reflect the actual services provided for one of four sampled patients (Patient 1) when RN 1 did minimal and generic documentation about wound care and caregiver education in her visit notes. This failure placed Patient 1 at risk for not receiving service as indicated in the plan of care (POC-a document that outline the health conditions, specific care needs and current treatments of a patient) due to an inaccurate documentation of service provided. Findings: During a concurrent interview and record review on 6/20/24 at 10 a.m., with the Clinical Supervisor (CS), Patient 1’s POC dated 1/10/24 to 3/9/24 was reviewed. The POC indicated, “Skilled nursing (SN): 1 visit per week for 9 weeks: SN for wound care to common bile duct drain, disease process education … SN to assess skin for breakdown each visit. SN to instruct on and perform common bile duct dressing change weekly as follows: using sterile technique, remove old dressing, cleanse area with [brand name sterile antiseptic solution], cover site with split drainage sponge and [brand name transparent medical dressing], add securement device as needed.” During a concurrent interview and record review of Patient 1's Skilled Nursing visit notes, dated 1/10/24, the note indicated RN 1 performed the initial assessment on 1/10/24. There was no documented evidence of who was Patient 1’s primary caregiver and what education was provided upon visit. SN visit notes dated 1/24/24, 1/31/24, 2/12/24, 2/22/24 and 2/28/24 were reviewed. The wound care note had minimal information with check marks and the narrative document was entered in a form copied and pasted from previous visit notes. In each visit note, there was no documentation of feedback from the caregiver. The CS stated she expected each visit notes should not be identical for each visit. The CS stated it was her expectation for RN 1’s wound care and caregiver education to be more comprehensive and reflected progress or decline determining the need for more education. RN 1 was no longer employed with the agency and unable to interview. During a review of the agency’s job description for “Registered Nurse”, undated, the job description indicated, “… maintains accurate and timely documentation of care/services provided ...”

The following reflects the findings of the California Department of Public Health-Licensing and Certification, during the Compliant Validation Survey for CA00728926. Representing the California Department of Public Health-Licensing and Certification: Federal ID #40030, HFEN The inspection was limited to the Conditions of Participation (COP) authorized by the Centers for Medicare & Medicaid Services (CMS): 484.50 Patient rights 484.55 Comprehensive Assessment of Patients 484.60 Care planning, coordination, quality of care 484.70 Infection prevention and control 484.80 Home health aide services 484.100 Compliance with Federal, State and Local Law Two Conditions of Participation (COP's) were determined to be NOT MET. 486.60 Care Planning, coordination, quality of care 484.100 Compliance with Federal, State, Local Law

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to assess patient nursing needs for one of six patients, patient (Pt) 1, when the agency did not implement care interventions to address recurrent UTIs (infection in any part of the urinary system that could lead to infection in the blood causing a life threatening event). This failure had the potential to result in Pt 1 having care needs go unmet for UTIs and lead to hospitalizations of sepsis (occurs when chemicals released in the bloodstream to fight in infection trigger inflammation throughout the body that can cause changes that damage multiple organs, leading them to fail, sometimes even resulting in death). Findings: During a concurrent interview and record review, on 4/13/21, at 10 a.m., with Registered Nurse (RN) 1, Pt 1's "Recertification" (continuation of home health care), dated 2/15/21 was reviewed. The recertification indicated, nursing visits would continue on 3/1/21. RN 1 stated Pt 1 had a decrease in visit frequencies after the recertification on 2/15/21 to continue home health care. RN 1 stated visits were going to be reduced to two visits per month starting on 3/1/21. RN 1 stated Pt 1's condition was stable and deemed to have only the needs to change the foley catheter every month along with education on medications. RN 1 stated there were no nursing visits scheduled for the week of 2/22/21 [week after Pt 1 recertification] until 3/1/21. During a concurrent interview and record review, on 4/14/21, at 12:13 p.m., with RN 1, Pt 1's hospital "Progress Note (PN)", dated 12/14/21, indicated, " ...Admitting Diagnosis; Severe Sepsis w [with] Acute Organ Dysfunction (impairment in the function of bodily organ or system) ...76 year old male with history of BPH ...Severe Sepsis with Acute Organ Dysfunction, chronic Indwelling Foley catheter ...Recurrent UTI (with a recent Psuedomonas [bacteria found in urinary system] and Proteus [bacteria found in urinary system] UTI was brought in on 12/14/21 for an acute altered mental status and decreased urine output of one day's duration ..." RN 1 stated the agency used the PN from the hospital as a reference to assess the care needs of the patients before admission to home health. RN 1 stated Pt 1 was in the hospital prior to admission to the home health agency. RN 1 stated Pt 1 had been admitted to the hospital on 12/14/20 for severe sepsis with acute organ dysfunction due to a UTI. RN 1 stated Pt 1 had a history of recurrent UTI's based on the history and physical (HP) of Pt 1. RN 1 stated Pt 1's recurrent UTI's suggested Pt 1 would be prone to UTI's in the future. RN 1 stated Pt 1's comprehensive assessment before admission should have assessed the need for care interventions to address recurrent UTI's. RN 1 stated the agency needed include interventions to change Pt 1's Foley catheter, provide urinalysis (UA, test for urine to detect and manage a UTI) orders, have the proper equipment available such as catheter sizes and syringe sizes to collect urine specimens, and the need to have prompt coordination with Pt 1's PCP. RN 1 stated it was important to assess all needs of Pt 1 to deliver the proper care. RN 1 stated it was important assess all needs of Pt 1 and avoid recurrent hospitalizations. RN 1 stated the goal of home health is to provide nursing care at home. RN 1 stated it was his responsibility as a nurse supervisor to assess Pt 1's care needs and implement interventions to care for Pt 1 at home. During a concurrent interview and record review, on 4/14/21, at 12:13 a.m., with RN 1, Pt 1's "Physician Order (PO)", dated 2/23/21 was reviewed. The PO indicated, " ...UA to be done next SN [skilled nursing] visit ..." stated the time from the R visit on 2/15/21 and the next SN visit on 3/1/21 was two weeks. RN 1 stated during the two weeks when no SN visit was done Pt 1 could have developed UTI and sepsis. RN 1 stated the frequency of visits could have been increased. RN 1 stated should have been assessed more frequently and could have done a UA sooner than 3/1/21. RN 1 stated a PRN (as needed) could have been done before 3/1/21 to collect a urine specimen and assess the need for further nursing interventions such as order for an antibiotic. During a review of the agency policy and procedure titled, "Initial and Comprehensive Assessment", dated 11/20, indicated, " ...The assessment will be patient-specific and comprehensive to include the patient's needs for home care ...4. During the initial and comprehensive patient assessment, all baseline data to be used in measuring the patient's progress towards goals and other relevant information will be documented in the patient's clinical record ...A. All pertinent diagnosis that may affect the need for services ...E. Patient's medical and psychosocial history, including pertinent diagnosis and prognosis ...M. Equipment presently in the home and potentially needed by the patient ...5. The comprehensive assessment shall reflect and determine: A. Patient problems/needs/strengths ...F. Baseline information to be used to measure the patient's progress toward achievement of desired outcomes G. Plan of care, including type of services, frequency, and duration ...I. Any information that may be used to demonstrate the patient's progress towards achievement of the goals identified by the patient and the measureable outcomes identified by the organization ..." During a review of the agency's job description summary titled, "Clinical Supervisor", dated 11/20, indicated, " ...The Clinical Supervisor is responsible for ensuring that patient care is coordinated and managed appropriately. The Clinical Supervisor is responsible for ensuring that care and services are delivered appropriately as well as the supervision of clinical personnel ...2. Reviews and evaluates each case by reviewing the services provided by clinicians, conferences, record review, discusses and verifies impressions, instructs and guides clinicians to promote more effective performance and delivery of quality home care services ..."

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to review all the medications and update the medication profile with the current medications for four of four sampled patients (Pt) with home visits (Patient 2, 3, 4 and 5). These failures had the potential to put the patients at risk for ineffective drug therapy, potential adverse effects, and drug reactions. Findings: During an observation on 3/24/21, at 10:38 a.m., in Pt 2's home, Registered Nurse (RN) 2 asked Pt 2's family member (FM) 2 about updates to new medications Pt 2 was taking. RN 2 did not physically assess medications in Pt 2's home. During an interview on 3/24/21, at 11 a.m., with Registered Nurse (RN) 2, RN 2 stated Pt 2's medication profile needed to update to reflect all medications Pt 2 was taking. RN 2 stated she did not physically see all medications Pt 2 was on but would ask FM 2 about the current medications Pt 2 was taking. During a concurrent observation and interview on 3/24/21, at 11:20 a.m., with Pt 2's family member (FM) 2, in Pt 2's home, there was a medication bottle, dated 2/24/21, indicating, " ...Lorazepam (used to treat seizures, anxiety) 0.5 mg (miligrams) 1 tab every 6 hours PRN (as needed) for agitation ..." There was a medication bottle, undated, indicating, " ...Melatonin 2.5 mg 1 daily ..." FM 2 stated Pt 2 had been taking the medications since before being admitted to the agency. During a review of Pt 2's "Certification and Plan of Care (C)", dated 2/24/21, the "C" indicated " ...Start of Care Date 2/24/21 ..." Pt 2's "Medication Profile (MP)", dated 2/24/21-4/24/21, indicated, no profile of Lorazepam or Melatonin. During a concurrent observation and interview on 3/24/21, at 2:20 p.m., with Pt 3's family member (FM) 3, in Pt 3's home, FM 3 stated he would give Pt 3's medications. FM 3 retrieved Pt 3's medication and there was a medication bottle indicating, " ...Acetaminophen 325 mg 1 tab PO (by mouth) every 4 hours ..." During a review of Pt 3's "C", dated 3/4/21, the "C" indicated " ...Start of Care Date 3/4/21 ..." Pt 3's MP, dated 3/8/21-5/6/21, indicated, " ...Acetaminophen Oral 325 MG 2 Tabs every 6 hours PRN pain ..." During an observation on 3/25/21, at 10:52 a.m., in Pt 4's home, LVN 3 asked Pt 4's FM 4 about updated medications. FM 4 stated there was a discontinuation of insulin glargine (long acting medication used to treat diabetes mellitus-disease that results in too much sugar in the blood). LVN 4 did not physically see the medications that were updated. During an interview on 3/25/21, at 11:30 a.m., with LVN 3, LVN 3 stated she updated Pt 4's medications by asking FM 4 about any updates to medications the primary care provider (PCP) may have made. LVN 3 stated Pt 4's medications would have been profiled at the start of care date and any updates on medications were communicated between nurses and Pt 4 and FM 4. LVN 3 stated she did not have to physically see updated medications to profile medications. During a concurrent observation and record review on 3/25/21, at 11:45 a.m., with FM 4, in Pt 4's home, FM 4 stated all Pt 4's medications were in the living area. FM 4 gathered all Pt 4's medications. There was a box indicating, " ...Humulin N (intermediate-acting medication used to treat diabetes mellitus) 100 units/ml (milliliter) vial 10 ml Inject 35 units subcutaneously (under the skin) in the morning and inject 35 units subcutaneously in the evening or as directed by care manager ..." There was a box indicating, "Humulin R (short-acting medication used to treat diabetes mellitus) 100 units/ml vial 10 ml Inject 10 units plus correction (dose given whenever a blood glucose level is above target rate) subcutaneously 20 to 30 minutes before breakfast and dinner. If blood glucose (sugar) (BG) 90 or less, no insulin; BG 140 or less no correction amount, BG 141 to 180 inject 4 units, BG 181 to 240 inject 8 units, BG 241-300 inject 12 units, BG 301-399 inject 16 units, BG 400 or higher inject 20 units. Call [PCP phone number] if BG is above 400 ..." There was a box indicating, " ...Albuterol sulfate (inhalation solution used to treat bronchospasm in people with obstructive airway disease) 2.5 mg/3ml (0.083%) ...use 1 vial nebulizer (drug delivery device used to administer medication in the form of a mist inhaled into the lungs) every 2 hours as needed for shortness of breath or wheezing ..." There was a box indicating, " ...Ipratropium bromide (inhalation solution used to enlarge airways in the lungs) 0.02%...Use 2.5 ml via nebulizer every 6 hours ..." There was a medication bottle indicating, " ...Prednisone 20 mg tablet take 1 and one-half tablets every morning ..." There was a medication bottle indicating, " ...[brand name] (Potassium chloride-mineral supplement used to prevent low amounts of potassium) 8 meq (milliequivalent) tablet take 1 tablet by mouth daily ..." There was a medication bottle indicating, " ...Baclofen 10 mg tablet take one-half tablet via PEG tube (tube placed through the abdominal wall and into the stomach used for administering nutrition and medications) 4 times a day ..." There was medication bottle indicating, " ...Metoprolol tartrate (used to treat high blood pressure) take one-half tablet by mouth 2 times a day ..." There was a medication bottle indicating, " ...Duloxetine (antidepressant used to treat chronic muscle or bone pain) 30 mg capsule ...take 1 capsule by mouth 2 times a day ..." There was a box of patches indicating, " ...(Lidocaine-used to treat irregular heartbeats and relieve pain and numb the skin) 4 % Topical patch apply 1 patch to the affected area(s) every 8 hours ..." There was a box of patches indicating, " ...Fentanyl 25 mcg/hr (microgram/hour, pain medication) ...apply 1 patch to skin every 72 hours ..." There was a medication bottle indicating, " ...Iron 65 mg ...325 Ferrous sulfate (mineral used to treat iron deficiency anemia cause by having too little iron in the body) ..." FM 4 stated Pt 4 was taking iron supplement over the counter (OTC) two times a day. There was a medication bottle indicating, " ...Chest Congestion Relief Guaifenesin 400 mg ..." FM 4 stated Pt 4 was taking one tab of Guaifenesin OTC four times a day. There was a medication bottle indicating, " ...Stool softener Docusate sodium (used to increase the amount of water the stool absorbs in the gut, making the stool softer and easier to pass) 100 mg ..." FM 4 stated Pt 4 was taking two tabs of Docusate Sodium two times a day. During a review of Pt 4's "C", dated 3/4/21, indicated, " ...Start of Care Date 3/4/21 ..." Pt 4's MP, dated 3/4/21-5/2/21, indicated, " ...Humulin N Subcutaneous 100 unit/ml 10 ml Give 50 units Subcutaneous injection in the morning Give 35 units Subcutaneous injection at bedtime ...Sliding scale for Reg [regular] Insulin: BS 60-149 0 units, 150-199 3 units, 200-249 6 units, 250-299 9 units, 300-349 12 units, 350-399 15 units, 400-449 18 units. If above 450 give 20 units ...Ipratropium-Albuterol Inhalation 0.5-2.5 (3) mg/3ml 3 ml via Neb [nebulizer] TX [every] 6 HRS [hours] ...Prednisone Oral 10 mg 3 tab(s) PO QDay [daily] ...Potassium Chloride Oral 20 MEQ/15ml (10%) 7.5 ml PO BID [twice a day] ...Baclofen Oral 5 MG 1 tab(s) PO QID [four times a day] ...Metoprolol Tartrate Oral 50 MG 1 tab(s) PO BID ...Duloxetine ...Oral 40 MG 1 cap(s) PO QDay ..." Pt 4's MP did not indicate Albuterol Sulfate, Lidocaine, Fentanyl, Ferrous sulfate, Guaifenesin, nor Docusate Sodium as being reconciled by the agency. During an observation on 3/30/21, at 10 a.m., in Pt 5's home, LVN 4 asked Pt 5's FM 5 about updates to medications. FM 5 told LVN 5 there were no changed to medications During an interview on 3/30/21, at 11 a.m., with LVN 4, LVN 4 stated she would ask FM 5 about changes to medications for Pt 5 and make updates to MP but would not physically see and read the labels of all medications. During a concurrent observation and interview on 3/30/21, at 11:20 a.m., with FM 5 and Pt 5's caregiver (CG), in Pt 5's home, FM 5 gathered Pt 5's medications. There was a medication bottle indicating, " ...[brand name] (plecanatide-used to treat chronic constipation (difficulty passing stool) and irritable bowel syndrome (intestinal disorder causing pain in the stomach, gas, diarrhea, and constipation)) 3 mg 1 tab PO daily ..." There was a medication bottle indicating, " ...Docusate sodium 100 mg 3 tabs daily ..." There was a medication bottle indicating, " ...Melatonin (used to control sleep-wake cycles) 5 mg 2 tabs at night ..." There was a bottle indicating, " ...Ketoconazole 2% Shampoo ...2-3x/week [times per week] ..." During a review of Pt 5's "C", dated 3/23/21-5/21/21, indicated, " ...Start of Care Date 7/26/20. Pt 5's MP, dated 3/23/21-5/21/21, indicated, " ...Ketoconazole External 2% 1 QD (daily) apply to feet ..." Pt 5's MP did not indicate plecanatide, Docusate sodium, nor Melatonin as being profiled by the agency. During an interview on 4/15/21, at 1:30 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated her expectation was for LVNs and RNs to update medication profiles of all patients. The DPCS stated it was important for Pt 2, 3, 4, and 5 to have all the medications prescribed by the PCP, OTC medications or any other medications taken by the patients at home to be reflective of the MP's to ensure patient safety and prevent medication interactions, unavailability of medications that could result in harm to the patients. During a review of the agency's policy and procedure titled, "Medication Profile", dated 11/20, indicated, " ...Patients receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each chance to reflect current medications, new, and/or discontinued medications ...1. Upon admission to the organization, the admitting clinician will initiate a medication profile to document the current medication regimen ...2. A Drug regimen review will be performed at the time of admission ...with the addition of a new medication ...3. During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver as well as other clinicians understand the medication regimen. This includes, but will not be limited to: A. Using the medication profile to evaluate the use of medications in the home setting. The medication profiled includes, but is not limited to: all current medications, date prescribed, name of medication, dose, frequency, drug classification, date discontinued, and drug and/or food allergies ..."

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, interview and record review, the Condition of Participation (COP) Care planning, coordination of services, and quality of care when: 1. The agency failed to follow physician orders to obtain a urine specimen for urinalysis (UA-test for urine to detect and manage a urinary tract infections [UTI]), for one of six sampled patients (Patient 1). ( Refer to G580) 2. The agency failed to promptly alert relevant changes to the Primary Care Provider (PCP) for one of six patients, patient (Pt) 1, when the agency did not notify the PCP that Licensed Vocational Nurse (LVN) 1 and LVN 2 did not collect a urinalysis (UA-test for urine to detect and manage a urinary tract infections [UTI]). (Refer to G590). The cumulative effect of this systemic failure resulted in the agency's substantial non-compliance in the provision of care in a quality and safe setting.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to follow physician orders to obtain a urine specimen for urinalysis (UA-test for urine to detect and manage a urinary tract infections [UTI]), for one of six sampled patients (Patient 1). This failure had the potential to delay identification and treatment of UTI and other bladder complications for Patient (Pt) 1. Findings: During an interview on 3/22/21, at 5 p.m., with Pt 1's family member (FM), the FM stated Pt 1 had signs of UTI for about a week and a half late February 2021. The FM stated the Registered Nurse Supervisor (RN) 1 told him, the agency needed an order from Pt 1's primary care provider (PCP) to collect urine for a UA. The FM stated Licensed Vocational Nurse (LVN) 1 came out one day to collect a UA, but could not obtain a specimen from Pt 1 because LVN 1 did not have the correct syringe size to obtain urine from the foley catheter (indwelling rubber tube inserted into the bladder to drain urine). The FM stated the agency instructed him to collect the urine specimen himself and a nurse would pick up the specimen. The FM stated, on 3/7/21, Pt 1 began to experience fever, pain, and loss of consciousness and PT 1 was taken to the hospital. Pt 1 was admitted with UTI and sepsis (infection in the blood). The FM stated when Pt 1 would have signs of UTI, the PCP would order an antibiotic (medications that fight bacterial infections). The FM stated the agency did not collect the urine specimen in a timely manner to address Pt 1's UTI and ultimately Pt 1 had to be hospitalized for sepsis. During a concurrent interview and record review, on 4/12/21, at 3 p.m., with LVN 1, Pt 1's "Skilled Nursing Visit (SNV)", dated 3/1/21 indicated, " ...[LVN 1] Attempted to collect UA, unable to gather specimen at this time ...Foley catheter not changed, per patient's [FM], he preferred that UA be done first before changing Foley because he believes pt [Pt 1] to have UTI ..." LVN 1 stated she could not obtain a urine specimen from Pt 1 on 3/1/21. LVN 1 stated she did not have the proper syringe to obtain urine from the urinary catheter port. During an interview on 4/12/21, at 3:35 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated LVN 1 needed to acquire a urine specimen ordered by the PCP. The DPCS stated in order to get a urine specimen, Pt 1 could have been instructed to drink a glass of water 30 minutes to one hour before the nurse visit to ensure Pt 1 could urinate and obtain a urine specimen. During a concurrent interview and record review, on 4/13/21, at 10 a.m., with the RN supervisor (RN) 1, Pt 1's "Physician Order (PO)", dated 2/23/21 was reviewed. The PO indicated, " ...UA to be done next SN [skilled nursing] visit ..."RN 1 stated an order needed to be collected on the next LVN visit on 3/1/21. RN 1 stated LVN 1 could not collect the urine specimen. RN 1 stated there was a PRN (as needed) nurse visit done on 3/2/21 to collect urine specimen from Pt 1. RN 1 stated LVN 2, who went out on 3/2/21 also was not successful in collecting urine from Pt 1. Pt 1's "SN PRN Visit," dated 3/2/21 indicated, " ...attempted to collect UA as per pt's [FM] request, attempt was unsuccessful, old catheter removed new Foley cath 16 fr [French-system used to measure size of a catheter] placed with no urine output ..." During an interview on 4/14/21, at 12:13 p.m., with RN 1, RN 1 stated when LVN 1 and 2 could not obtain a urine specimen from Pt 1, the agency could have sent Pt 1 to the hospital, or communicated with the PCP for blood labs to assess for possible sepsis. RN 1 stated by having a UA specimen, an infection or UTI could have been identified and promptly treated. RN 1 stated an antibiotic could have been ordered by the PCP in timely manner to prevent Pt 1 from getting sepsis. RN 1 stated sepsis could be an emergent situation for Pt 1 as it could cause organ failure and possibly death. During a review of Pt 1's "History and Physical Note" (H&P), dated 3/7/21, the HP indicated, " ...Chief Complaint: fever and chills x 1 day [for one day] ..." Pt 1's "Discharge Summary" (DS), dated 3/11/21, indicated, the DS indicated, " ...Hospital Course and Significant Findings: ...urinary retention with chronic indwelling foley catheter presenting with fever and chills. #Sepsis secondary to UTI in setting of indwelling catheter ...had urine cultures on 3/3/21 with pseudomonas (bacteria found in urinary system resulting in a UTI) that had not been treated. He was treated with IV [name of antibiotic] with resolution of sepsis and clinical improvement ..." During a review of the agency's policy and procedure titled, "Monitoring Patient's Response/Reporting To Physician", dated 11/20, indicated, " ...Clinicians will monitor, document, and report the patient's response to care and treatment provided on each home visit ...Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient ...3. The patient's physician will be contacted on the same day when any of the following occur:...C. Inability to achieve goals within the specified time frame ...F. When there is any problem implementing the plan of care ...4. All conferences or attempts to communicate with physician will be documented in the clinical record. A. Documentation of the physician notification will include: 1. Date and time contacted 2. Patient name 3. Name of physician notified or his/her representative 4. Reason for notification 5. Physician's response 6. Action taken or orders obtained 7. Professional's signature and title B. Documentation of attempted physician notification will include: 1. Date and time 2. Patient name 3. Name of physician attempting to notify 4. Reason for notification 5. Name of person taking message ...C. If the Clinical Supervisor or designee is unable to contact the patient's physician, the Clinical Supervisor or designee will notify the organization's Medical Director of the change in patient condition and the inability to contact the patient's physician to request medical consultation ..." During a review of the agency's policy and procedure titled, "Physician Participation in Plan of Care", dated 11/20, indicated, "...The care will be provided in compliance with the therapuetic and diagnostic orders and accepted standards and practice...B. Treatments and/or procedures needed, including type, frequency, duration, and goals...2. When services are provided on the basis of a physician's verbal orders, a registered nurse, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law shall document the orders in the patient's clinical record, and sign, date, and time the orders...3. Orders are reviewed for appropriateness and accuracy before care, treatment and services are provided..." During a review of the agency's job description summary titled, "Licensed Practical/Vocational Nurse", dated 11/20, indicated, " ...The Licensed Practical/Vocational Nurse is responsible for providing direct patient care under the supervision of a registered nurse. Responsibilities include following the plan of care, providing treatments, and working collaboratively with the members of the team to help meet positive patient care outcomes ...2. Implements plan of care initiated by the registered nurse ...3. Provides accurate and timely documentation consistent with the plan of care ...6. Uses and/or prepares equipment and supplies effectively and efficiently ..."

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 interview and record review, the agency failed to promptly notify the Primary Care Provider (PCP) for one of six patients, patient (Pt) 1, when the agency did not notify the PCP that LVN 1 and LVN 2 did not collect a urine specimen needed for urinalysis (UA-test for urine to detect and manage a urinary tract infections [UTI]). This failure resulted in the PCP not knowing the order for urinalysis was not promptly carried out, and placed Pt 1 at risk for untreated UTI and other bladder complications for Patient (Pt) 1. Findings: During an interview on 3/22/21, at 5 p.m., with Pt 1's family member (FM), the FM stated Pt 1 had signs of UTI for about a week and a half late February 2021. The FM stated the Registered Nurse Supervisor (RN) 1 told him, the agency needed an order from Pt 1's primary care provider (PCP) to collect urine for a UA. The FM stated Licensed Vocational Nurse (LVN) 1 came out one day to collect a UA, but could not obtain a specimen from Pt 1 because LVN 1 did not have the correct syringe size to obtain urine from the foley catheter (indwelling rubber tube inserted into the bladder to drain urine). The FM stated the agency instructed him to collect the urine specimen himself and a nurse would pick up the specimen. The FM stated, on 3/7/21, Pt 1 began to experience fever, pain, and loss of consciousness and PT 1 was taken to the hospital. Pt 1 was admitted with UTI and sepsis (infection in the blood). The FM stated when Pt 1 would have signs of UTI, the PCP would order an antibiotic (medications that fight bacterial infections). The FM stated the agency did not collect the urine specimen in a timely manner to address Pt 1's UTI and ultimately Pt 1 had to be hospitalized for sepsis. During a concurrent interview and record review, on 4/12/21, at 3 p.m., with LVN 1, Pt 1's "Skilled Nursing Visit (SNV)", dated 3/1/21 indicated, " ...[LVN 1] Attempted to collect UA, unable to gather specimen at this time ...Foley catheter not changed, per patient's [FM], he preferred that UA be done first before changing Foley because he believes pt [Pt 1] to have UTI ..." LVN 1 stated she could not obtain a urine specimen from Pt 1 on 3/1/21. LVN 1 stated she did not have the proper syringe to obtain urine from the urinary catheter port. During a concurrent interview and record review, on 4/13/21, at 10 a.m., with RN 1, Pt 1's "Physician Order (PO)", dated 2/23/21 was reviewed. The PO indicated, " ...UA to be done next SN [skilled nursing] visit ..." RN 1 stated an order needed to be collected on the next LVN visit on 3/1/21. RN 1 stated LVN 1 could not collect the UA on 3/1/21. During an interview on 4/14/21, at 1:35 p.m., with LVN 1, LVN 1 stated she did not inform Pt 1's PCP of the unsuccessful attempt to obtain a urine specimen on 3/1/21. LVN 1 stated she should have informed the PCP of the inability to carry out the UA order but forgot to input in Pt 1's electronic chart. During an interview on 4/15/21, at 1:30 p.m., with the DPCS, the DPCS stated LVN 1, LVN 2, and RN 1 should have informed the PCP when the urine specimen was not obtained on 3/1/21, or 3/2/21. The DPCS stated it was important to notify the PCP in a timely manner to ensure the physician orders were being followed to prevent Pt 1 from being septic and admitting to the hospital. During a review of the agency's policy and procedure titled, "Monitoring Patient's Response/Reporting To Physician", dated 11/20, indicated, " ...Clinicians will monitor, document, and report the patient's response to care and treatment provided on each home visit ...Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient ...3. The patient's physician will be contacted on the same day when any of the following occur:...C. Inability to achieve goals within the specified time frame ...F. When there is any problem implementing the plan of care ..." During a review of the facility policy and procedure titled, "Coordination of Services With Other Providers", dated 11/20, indicated, " ...The Case Manager will act as liaison with other organizations or individuals also providing care to the patient to assure effective coordination or related services ...3. The Case Manager will be responsible for the coordination between service providers, which will include, but not limited to: ...B. Initiation of communication with other organizations/individuals when there are significant changes in the patient's overall care ..." During a review of the agency's job description summary titled, "Licensed Practical/Vocational Nurse", dated 11/20, indicated, " ...The Licensed Practical/Vocational Nurse is responsible for providing direct patient care under the supervision of a registered nurse. Responsibilities include following the plan of care, providing treatments, and working collaboratively with the members of the team to help meet positive patient care outcomes ..."

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the agency failed to implement an infection prevention and control program when: 1. Licensed Vocational Nurse (LVN) 3 did not perform hand hygiene during a home visit for patient (Pt) 4. 2. LVN 4 did not perform hand hygiene during a home visit for Pt 5. 3. LVN 4 did not use sterile technique (set of practices and procedures performed to make equipment and areas free from all microorganisms) when inserting an indwelling urinary catheter for Pt 5. 4. LVN 4 did not use proper bag technique during a home visit for Pt 5. These failures had the potential to result in cross contamination (process by which microorganisms are unintentionally transferred from one substance or object to another with harmful effect) for Pt 4 and 5 that could lead to illness or death. Findings: 1. During an observation on 3/25/21, at 10:54 a.m., in Pt 4's home, LVN 3 had gloves on and was using a stethoscope (medical device used to listen to internal sounds of a human body) to listen to lung and bowel sounds. LVN 3 removed her gloves, disposed the gloves in a receptacle and proceeded to grab a pen and paper without performing hand hygiene. LVN 3 placed gloves on and palpated Pt 4's abdomen, removed gloves and touched a pen and paper again without performing hand hygiene. During an interview on 3/25/21, at 11:30 a.m., with LVN 3, LVN 3 stated she should have performed hand hygiene using an alcohol-based hand rub after removing her gloves and touching a pen and paper. LVN 3 stated it was important to perform hand hygiene in between glove use to prevent cross contamination between patients and prevent them from becoming ill. During a review of the agency policy and procedure titled, "Hand Hygiene", dated 11/20, indicated, " ...3. Hand decontamination using an alcohol-based hand rub should be performed ...B. Before donning sterile gloves when performing sterile procedures; before inserting indwelling urinary catheter ...F. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. G. After removing gloves ..." 2. During an observation on 3/30/21, at 10:15 a.m., in Pt 5's home, LVN 4 performed vital signs (clinical measurements such as pulse rate, temperature, respiration rate, and blood pressure that indicate the state of a patient's body functions) on Pt 5 with a blood pressure cuff, thermometer, and stethoscope. LVN 4 wiped medical supplies with a disinfectant wipe, removed her gloves and placed new gloves on without performing hand hygiene. During an observation on 3/30/21, at 10:40 a.m., in Pt 5's home, LVN 4 opened an indwelling urinary catheter kit (box containing supplies to insert an indwelling catheter) removed her gloves and placed on sterile gloves from the catheter kit without performing hand hygiene. During an interview on 3/30/21, at 11 a.m., with LVN 4, LVN 4 stated she needed to perform hand hygiene with an alcohol based rub in between glove use and before putting on sterile gloves for an indwelling urinary catheter insertion. LVN 4 stated it was important to perform hand hygiene in between glove use to prevent cross contamination between patients and prevent them from becoming ill. During a review of the agency policy and procedure titled, "Hand Hygiene", dated 11/20, indicated, " ...3. Hand decontamination using an alcohol-based hand rub should be performed ...B. Before donning sterile gloves when performing sterile procedures; before inserting indwelling urinary catheter ...F. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. G. After removing gloves ..." 3. During an observation on 3/30/21, at 10:47 a.m., in Pt 5's home, LVN 4 opened the indwelling urinary catheter kit, applied sterile gloves, opened betadine (topical solution used to prevent skin infections used to prepare an indwelling urinary catheter insertion) packet with both hands, poured solution on cotton swabs in the catheter tray. LVN 4 picked up a cotton swab with right hand and used the left had to hold Pt 5's penis to apply betadine on penial opening. LVN 4 proceeded to use both hands to open plastic containing catheter tubing and inserted catheter into Pt 5's urethra (duct by which urine is conveyed out of the body from the bladder). During an interview on 3/30/21, at 11 a.m., with LVN 4, LVN 4 stated she needed to open plastic containing the catheter tubing before applying betadine swab to Pt 5's penis. LVN 4 stated she did not abide by sterile technique. LVN 4 stated it was important to follow sterile technique when inserting an indwelling urinary catheter to prevent introduction of bacteria into Pt 5's bladder. LVN 4 stated Pt 5 could develop a urinary tract infection and lead to harmful effects such as sepsis (occurs when chemicals released in the bloodstream to fight in infection trigger inflammation throughout the body that can cause changes that damage multiple organs, leading them to fail, sometimes even resulting in death). During a review of the agency policy and procedure titled, "Steps on How to Insert a Foley Catheter" (undated), indicated, " ...Carefully remove the plastic that covers the catheter without touching the tube ...7. Clean the urinary opening ...Using the non-dominant hand ...Do not touch anything after this with the unclean, non-dominant hand. For a male patient, gently clean the peri-urethral mucosa with a cleaning solution ...8. Using the sterile dominant hand, pick up the catheter with a gloved hand. Holding the catheter loosely ...For a male patient, lift his penis to a perpendicular position and lightly apply traction in an upward position using the non-dominant hand ..." 4. During an observation on 3/30/21, at 10:27 a.m., in Pt 5's home, LVN 4 placed a container of alcohol based hand rub on Pt 5's bed without a barrier and LVN 4 did not disinfect the container of alcohol based hand rub after use. During an interview on 3/30/31, at 11 a.m., with LVN 4, LVN 4 stated all items used in a home visit should have been on top of a barrier and not a patient's bed. LVN 4 stated having an alcohol based hand rub on Pt 5's bed could lead to cross contamination and place other patients for home visits at risk of becoming ill. During a review of the agency policy and procedure titled, "Bag Technique", dated 11/20, indicated, " ...5. When the visit is complete, reusable equipment will be cleaned using alcohol, soap and water, or other appropriate solution, hands will be washed, and equipment and supplies will be returned to the bag ..."

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the agency failed to implement an infection prevention, and control program when: 1. The agency did not implement a surveillance program of Coronavirus (COVID-19-a serious respiratory illness caused by a virus which is the cause of a current worldwide pandemic [prevalent over a whole country or the world]) for all clinicians doing patient home visits. 2. The agency did not have a designated staff member to screen all individuals entering the agency building. These failures had the potential to result in transmission of the COVID-19 virus to patients in their home that could result in illness or death. Findings: 1. During an interview on 3/25/21, at 11:30 a.m., with Licensed Vocational Nurse (LVN) 3, LVN 3 stated if she were to have COVID-19 symptoms (fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea) she would not report to work. LVN 3 stated she did not report a temperature or self-screening of symptoms of COVID-19 to a clinical supervisor prior to beginning home visits. LVN 3 stated there was no screening of clinicians for symptoms of COVID-19 every day prior to entering patients' homes. During an interview on 3/30/21, at 11 a.m., with LVN 4, LVN 4 stated clinicians were educated on calling in to the agency for any COVID-19 symptoms they may experience to prevent working sick. LVN 4 stated she was not screened on a daily basis to ensure she was not working while having COVID-19 symptoms. LVN 4 stated all clinicians understood not to work while ill from COVID-19. During an interview on 3/30/21, at 1:10 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated clinicians were to call in to supervisors of any symptoms of COVID-19 they may experience and stay home from work. The DPCS stated all clinicians were responsible for assessing themselves for any COVID-19 symptoms and understood not to work while sick. The DPCS stated there was no specific surveillance or screening process done daily to document every clinicians' temperature or COVID-19 symptoms. During an interview on 3/30/21, at 2:30 p.m., with the Administrator (ADM), the ADM stated there was no screening process of clinicians that included daily temperature checks nor supervisors assessing clinicians' symptoms of COVID-19. The ADM stated clinicians went from their home to patients' home at the start of the working day and did not come into the agency building to be screened for COVID-19 symptoms. The ADM stated there should have been a surveillance program implemented to document all clinicians' temperatures and symptoms screened before the start of their workday. During an interview on 4/15/21, at 1:30 p.m., with the DPCS, the DPCS stated there should have been a screening process implemented to detect COVID-19 symptoms for all clinicians daily. The DPCS stated it was important to have a surveillance program of all clinicians' temperatures and symptoms to prevent patients and family members from becoming infected with COVID-19. The DPCS stated if clinicians were not screened daily, and worked with COVID-19 symptoms, clinicians could be spreading the COVID-19 virus from patient to patient. During a review of the agency policy and procedure titled, "Pandemic Infectious Disease", (undated), indicated, " ...7. Staff with signs and symptoms of a respiratory infection should not report to work ..." 2. During an observation on 3/30/21, at 8:33 a.m., in the agency building, the Health Facilities Evaluator Nurse (HFEN) entered the building without being screened for COVID-19 symptoms. During an observation on 4/12/21, at 9:30 a.m., in the agency building, the HFEN entered the building without being screened for COVID-19 symptoms. During an observation on 4/13/21, at 8:40 a.m., in the agency building, the HFEN entered the building without being screened for COVID-19 symptoms. During an interview on 4/13/21, at 8:45 a.m., with the Receptionist (R), the R stated the staff who enter the agency building self-screen before entering. The R stated there was no person designated to check all staff who came into the office. During an interview on 4/15/21, at 1:30 p.m., with the DPCS, the DPCS stated all visitors coming into the agency building needed to be screened for COVID-19 symptoms and have their temperature checked by a designated staff member. The DPCS stated the R should have screened the HFEN for COVID-19 symptoms and temperature to ensure the prevention of COVID-19 transmission to other staff. During a professional reference review, retrieved on 4/26/21, from https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html, titled, "Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", dated 2/23/21, indicated, " ...Screen and Triage Everyone Entering a Healthcare Facility for Signs and Symptoms of COVID-19 ...Although screening for symptoms will not identify asymptomatic or pre-symptomatic individuals with SARS-CoV-2 infection, symptom screening remains an important strategy to identify those who could have COVID-19 so appropriate precautions can be implemented ...Establish a process to ensure everyone (patients, healthcare personnel, and visitors) entering the facility is assessed for symptoms of COVID-19, or exposure to others with suspected or confirmed SARS-CoV-2 infection and that they are practicing source control. Options could include (but are not limited to): individual screening on arrival at the facility; or implementing an electronic monitoring system in which, prior to arrival at the facility, people report absence of fever and symptoms of COVID-19, absence of a diagnosis of SARS-CoV-2 infection in the prior 10 days, and confirm they have not been exposed to others with SARS-CoV-2 infection during the prior 14 days ..."

Compliance with Federal, State, Local Law CFR(s): 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. If state or local law provides licensing of HHAs, the HHA must be licensed. This CONDITION is not met as evidenced by: Based on observation, interview and record review, the Condition of Participation (COP) for Compliance with Federal, State, and local laws and regulations related to the health and safety of patients was determined to be NOT MET when the agency advertised the Modesto and Bakersfield locations as branch locations (a location or site from which an HHA provides services). The cumulative effect of this systemic failure resulted in the agency's substantial non-compliance in the provision of care in a quality and safe setting.

Licensing CFR(s): 484.100(b) (b) Standard: Licensing. The HHA, its branches, and all persons furnishing services to patients must be licensed, certified, or registered, as applicable, in accordance with the state licensing authority as meeting those requirements. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the agency failed to follow federal, state, and local laws when the agency did not follow federal regulations for home health agency (HHA) drop sites (location for field staff to pick up supplies, drop off paperwork, use office equipment) when the HHA advertised the Bakersfield and Modesto sites as branch locations (a location or site from which an HHA provides services within a portion of the total geographic area). This failure had the potential to mislead patients and primary care providers (PCP) of the agency's State Licensure and mislead the public into perceiving drop site locations were operating as HHA branch locations that provide care to patients needing home health services in the community. Findings: During an observation on 3/23/21, at 11:05 a.m., outside the parking lot of [agency name], there was a signage visible from the main street indicating the address of [agency name] in Modesto, CA. The entrance door to the agency building indicated business hours of operation "M-F [Monday through Friday] 8:00 am-5:00 pm". During a concurrent interview and record review on 3/29/21, at 10:22 a.m., with the Marketing Director (MD), the "[agency name]" brochure, (undated) was reviewed. The brochure indicated, " ...Modesto [street address] [phone number] ...Bakersfield [street address] [phone number] ..." The "[agency name]" map, (undated) was reviewed. The map indicated, " ...Modesto Location [street address] [phone number] [fax number] ...Bakersfield Location [street address] [phone number] [fax number] ..." The MD stated the office locations in Modesto and Bakersfield, CA were meant to be drop sites where clinicians can have a location to pick up supplies, review patient case conferences and meet with staff to receive education from superiors. The MD stated the agency brochure and map were used to ensure PCPs and patients knew that the agency was local and that clinicians were not traveling from Fresno, CA where the main HHA was located. The MD stated Modesto and Bakersfield, CA locations could mislead the public into perceiving drop site locations were operating as HHA branch locations. During an interview on 3/29/21, at 10:53 a.m., with the Chief Operating Officer (COO), the COO stated drop site locations were on the agency's brochure and map to ensure patients felt the agency was local. The COO stated the brochure and map did not indicate to the public the locations were only drop sites. The COO stated if locations were not advertised on the brochure and map, HHA competitors could claim the agency was operating only from Fresno, CA. During an interview on 4/12/21, at 9:30 a.m., with the Administrator (ADM), the ADM stated the drop site locations were in the process of becoming branch offices so they could operate in Modesto and Bakersfield, CA. The ADM stated advertising drop site locations as branches did not comply with federal and state regulations and needed to be changed. The ADM stated drop site locations needed to be advertised as drop sites or not mentioned at all on the brochure and map. During a review of the agency website titled, "Locations" (undated), indicated, " ...Modesto [street address] [phone number] ...Bakersfield [street address] [phone number] ..." There was no indication of the Modesto and Bakersfield sites were not branch offices. During a review of the "State Operations Manual Chapter 2 - The Certification Process (SOM)", dated 3/12/21, indicated, " ...Drop Sites (Rev 125, Issued: 10-31-14, Effective: 10-31-14, Implementation: 10-31-14) Where permitted by state and local law, an HHA may utilize a drop site for field staff convenience. These drop sites are not considered branches and should not meet the Medicare definition of a branch or operate as such. HHAs that allow these locations to cross the line from drop site to branch are out of compliance with the Medicare requirements. The HHA should not assign staff to these locations, accept referrals at these locations, advertise them as a part of the HHA, or operate them in any other way as branches of the HHA. HHAs that are unsure if the location meets the definition of a branch may seek advice from the SA. If the location does meet the definition of a branch, it must request CMS approval before providing services from this location. The HHA's policies on drop sites should reflect current Federal and State requirements, including compliance with the Health Insurance Portability and Accountability Act of 1996 privacy requirements. While these sites would not be subject to routine surveys, they may be subject to state or RO inspection at any time. Any violation would be addressed by the SA and referred to the CMS RO for any necessary program integrity investigation and follow up ..." During a review of the agency state license titled, "State of California Department of Public Health" dated 2/16/21, indicated, " ...this License to [agency name] to operate and maintain the following Home Health Agency [agency name] [Fresno, CA agency address] ..." State license did not indicate branch locations for Modesto and Bakersfield locations.