Healing Care Hospice, Inc.

“Upon patient record review, 1 of 19 (Patient #9) did not have evidence in the patient record that the hospice has developed an individualized written plan of care for each patient. The plan of care must reflect patient/family goals and interventions based on the problems identified in the initial, comprehensive, and updated comprehensive assessments. The plan of care must include all services necessary for the palliation and management of the terminal illness and related conditions. Patient 9: On the plan of care there is an order for coumadin, there is not a risk for bleeding with goals and interventions on the plan of care.”

“Upon patient record review, 1 of 19 (Patient #3) did not have evidence the plan of care must include all services necessary for the palliation and management of the terminal illness and related conditions, including medications and treatments. Patient 3: On the plan of care there is an order for a PleurX drain, there is not a frequency for when to drain the PleurX catheter, there is not instructions on how to drain the PleurX catheter, or when to call the doctor. In addition, on the plan of care there is an order for a CVC in the right brachial artery, there are no orders for frequency that state when to flush the catheter and instructions on how to care for the catheter.”

“Upon patient record review, 2 of 19 (Patient #3,7) did not have evidence the plan of care must include all services necessary for the palliation and management of the terminal illness and related conditions, including equipment and supply needs. Patient 3: On the plan of care there is evidence of a PleurX drain, there are not supplies listed for the PleurX drain on the plan of care. Patient 7: On the plan of care there is an order for activity, “transfer with hoyer lift”, there is not a hoyer lift listed in the DME on the plan of care.”

“Upon patient record review, 12 of 19 (Patient #1,3,5,6,7,8,9,10,11,12,13,14) did not have evidence in the patient record that hospice aide assignments and duties are: • Assigned to a specific patient by a registered nurse that is a member of the interdisciplinary group • Written patient care instructions for a hospice aide must be prepared by a Registered Nurse who is responsible for the supervision of a hospice aide as specified under paragraph (h) of 418.76 • There is evidence in the patient record that the plan of care; indicate what tasks are to be done by the Aide and the frequency of these tasks. The use of “PRN” or “per patient choice”, for any task, whether personal care or non-personal care tasks, are not acceptable Patient 1: On the aide plan of care there is an order to record bowel movements, there is not a frequency for this order. Patient 3: On the aide plan of care there is an order to turn and reposition, there is not a frequency for this order. Patient 5: On the aide plan of care there is an order to record bowel movements, there is not a frequency for this order. Patient 6: On the aide plan of care there is an order to turn and reposition, record bowel movements, change patient linens, there is not a frequency for these orders. Patient 7: On the aide plan of care there is an order to turn and reposition, measure urinary output, record bowel movements, change patient linens, there is not a frequency for these orders. Patient 8: On the aide plan of care there is an order to turn and reposition, record bowel movements, change patient linens, there is not a frequency for these orders. Patient 9: On the aide plan of care there is an order to record bowel movements, there is not a frequency for this order. Patient 10: On the aide plan of care there is an order to turn and reposition, record bowel movements, change patient linens, there is not a frequency for these orders. Patient 11: On the aide plan of care there is an order ,turn and reposition, record bowel movements, encourage fluids as tolerated if not contraindicated, there is not a frequency for these orders. Corrected on site. Patient 12: On the aide plan of care there is an order, feeding assistance, change patient linens, there is not a frequency for these orders. Patient 13: On the aide plan of care there is an order to turn and reposition, record bowel movements, change patient linens, feeding assistance, there is not a frequency for these orders. Patient 14: On the aide plan of care there is an order to record bowel movements, change patient linens, there is not a frequency for this order.”

“Based on interview and record review, the Hospice Agency (HA) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare [a federal health insurance for people 65 or older, and some people under 65 with certain disabilities or conditions] program) regarding Hospice Aide and Homemaker Services was met as follows: The hospice agency (HA) failed to ensure that one of 33 Certified Nursing Assistants (CNA 1) successfully completed competency testing, including safe transfer techniques prior to providing services to one of 23 sampled patients, Patient 1, who was admitted to the facility as high risk for falls by failing to: 1. Ensure Certified Nursing Assistant 1 (CNA1) may not be allowed to provide services to patients independently until the CNA 1 has successfully completed competency testing, including safe transfer techniques either at the HA or at another training facility, and the HA has verified successful completion through documentation provided by the applicant or the training facility. The deficient practice resulted in Patient 1, who was assessed as high risk for fall, was in the shower on 2/19/2024, and CNA 1 assisted the patient off the shower chair to the wheelchair and the patient fell forward and hit her head on the floor and sustained a hematoma (a pool of clotted blood that forms in a organ or issue) on left side of the head. Patient 1 was transferred to a general acute care hospital (GACH) where she was admitted to an intensive care unit (ICU) on 2/19/2024 due to having an acute left sided subdural hematoma caused by the Patient 1s fall incident. Twenty days after the fall, the patients health condition worsen, and Patient 1 passed away on 3/12/2024. (Refer to L 615) The cumulative effect of these systemic practices resulted in the failure of the HA to deliver statutorily mandated (written law) compliance with Federal Regulations for Hospice Aide and Homemaker Services to ensure highest quality health care is provided to patients assessed to receive hospice services.”

“Based on observation, interview and record review, the Hospice Agency (HA, agency providing care to terminally ill patients who has six months or less to live) failed to ensure the Condition of Participation regarding Initial and Comprehensive Assessment of the Patient was met as follows: The HA staff failed to conduct and document an accurate comprehensive assessment that reflected the patient’s current health status and identify patients’ need for hospice care and services related to hospice eligibility and management of terminal illness for two of 19 sampled patients (Patient 13 and Patient 14). (Refer to L524) The cumulative effect of this systemic practice resulted in the failure of the hospice to deliver statutorily (written law) mandated compliance with Federal regulation for Initial and Comprehensive Assessment of the Patient to ensure the quality of care are being provided to patients certified to receive the Medicare hospice benefits.”

“Based on an interview, and record review, the Hospice agency (HA, agency providing care to terminally ill patients who have six months or less to live), failed to meet the Condition of Participation (COP, refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) for Interdisciplinary Group (IDG, team members from different disciplines working collaboratively, with a common purpose, to set goals, make decisions and share resources and responsibilities), Care Planning, and Coordination of Services was met as follows: 1. The HA failed to ensure to follow the written plan of care (POC) for two of 23 sampled patients (Patient 1 and Patient 8). For Patient 1, the HA did not follow Patient 1’s POC to provide safe transfer, when HA did not provide CNA 1 training to educate on how to provide safe care using the safe transfer/repositioning techniques with the aid of appropriate equipment. For Patient 8, the Skilled Nurse (SN) did not provide provide wound care treatment to Patient 8’s right 4th finger/lesion. This deficient practice resulted in Patient 1 for an avoidable fall accident and had the potential for Patient 8’s wound not to heal. (Refer to L543). 2. The HA failed to notify the physician regarding the current medical condition for one out of 23 sampled patients, (Patient 1). The HA did not notify the Physician, when Patient 1 had fall accident. This deficient practice had the potential to cause delayed in care and services and further evaluation of Patient 1’s care needs that could affect the quality of end of life care goals. (Refer to L554). The cumulative effect of these systemic practices resulted in the failure of the HA to deliver statutorily (written law) mandated compliance with the IDG, Care Planning, and Coordination of Services to ensure the quality of care was provided to the patients who were assessed to receive hospice care and services.”

“Based on interview and record review, the Hospice Agency (HA, agency providing care to terminally ill patients who have six months or less to live) failed to ensure the Condition of Participation on Clinical Records was met as follows: 1.The HA failed to ensure any changes, corrections or late entries within an electronic health record clearly identified the original content, the modified content, date, and authorship of each record modification for one of 19 sampled patients (Patient 8). (Refer to L679). 2.The HA failed to ensure contents and information in the patients medical records were safeguarded from unauthorized access by HA staff and/or contracted staff to make any alterations or modifications. (Refer to L680). The cumulative effect of these systemic practices resulted in the failure of the hospice to deliver statutorily mandated compliance with Federal regulations for Clinical Records to ensure patients medical records are safeguarded from unauthorized access by any individuals or hospice staff.”

“Based on observation, interview, and record review, the Hospice Agency (HA) staff failed to conduct and document an accurate comprehensive assessment that reflected the patient’s current health status and identify patients’ need for hospice care and services related to hospice eligibility and management of terminal illness for two of 19 sampled patients (Patient 13 and Patient 14). This deficient practice resulted in the hospice claiming reimbursement for patients who did not need hospice care and service management of terminal illness and had the potential to result in Patient 13 and Patient 14 not receiving appropriate healthcare services that could affect their quality of life. Findings: a. During a review of Patient 13s demographics ((identifying information such as patients name, date of birth and address, along with insurance information) indicated a start of care (SOC) date of 10/11/2023 with a terminal diagnosis of chronic obstructive pulmonary disease (COPD, a group of lung diseases that block airflow and make it difficult to breathe), unspecified. During a review of Patient 13’s Comprehensive Recertification Nursing Assessment (Re-Cert Assessment, an assessment to identify the physical, psychosocial, emotional, and spiritual needs related to the terminal illness that must be addressed in order to promote the hospice patient’s well-being, comfort, and dignity throughout the dying process), dated 3/26/2024, indicated Patient 13 was awake, alert, oriented x 3 (to person, place, and time), had no cardiac-related pain, regular pulse (heart rate), had normal respirations (breathing), clear lung sounds, had mild dyspnea (shortness of breath) with mild exertion, and ambulatory using a walker. The Re-Cert Assessment also indicated Patient 13 was on New York Heart Association Class IV (NYHA class IV level, for patient who should be at complete rest, confined to bed or chair, any physical activity brings on discomfort and symptoms occurs at rest), for heart failure. During a review of Patient 13s Local Coverage Determination (LCD, describes guidelines to be used by National Government Services [NGS] in reviewing hospice claims and by hospice providers to determine eligibility of beneficiaries for hospice benefits) Hospice Eligibility Determination form for Pulmonary Disease, dated 3/26/2024, indicated Patient 13 was eligible per LCD guidelines. The LCD form indicated section 1 and at least one of the conditions in section 2 should be met. It was marked “yes” in section 1 that Patient 13 had a disabling dyspnea at rest as evidenced by being poorly responsive or unresponsive to bronchodilators (a type of medication that make breathing easier by relaxing the muscles in the lungs and widening the airways), resulting in decreased functional capacity. Section 2 was marked “;yes” that Patient 13 had hypoxia (low levels of oxygen in your body) as evidenced by O2 sat (oxygen saturation, the amount of oxygen you have circulating in your blood. Normal range will be around 95–100%) less than or equal to 88% determined either by arterial blood gases (a test that measures the oxygen and carbon dioxide levels in your blood) or O2 sat monitors. During a review of Patient 13’s “Physician Certification for Hospice Benefit” (or CTI, Physician’s certification of the patient being terminally ill to have Medicare hospice benefit) for the 7th benefit period from 4/08/2024 to 6/06/2024, indicated Patient 13 was hospice appropriate and has a life expectancy of six months or less if the terminal illness runs its normal course. The “;Physician Narrative” section indicated Patient 13 was alert, oriented x 3, denies any pain, able to ambulate with the assistance of a walker, had clear lung sounds, and O2 sat of 97% on room air. It did not indicate any supportive evidence Patient 14 met LCD Guidelines for pulmonary disease to continue hospice care and services. During a review of Patient 13’s clinical record indicated there was no documented evidence that Patient 13 had a disabling dyspnea at rest, was poorly responsive or unresponsive to bronchodilators, or had O2 saturation of 88% or less. There was also no documentation Patient 13 was on complete rest, confined to bed or chair, or any physical activity brings on discomfort and symptom at rest. During a joint home visit, on 4/17/2024 at 10:00 a.m. with a registered nurse (RN 2) at Patient 13s residence, Patient 13 was observed sitting on a recliner, was awake, alert, and oriented x 3, had normal breathing, not on oxygen, and had no shortness of breath. During an interview on 4/17/2024 at 10:16 a.m., Patient 13 stated he can walk around the house using a walker, used oxygen supplement only as needed at night for comfort, and his breathing treatment using a bronchodilator medication was his lifesaver and very effective in case he had episodes of shortness of breath. During an interview on 4/19/2024 at 10:18 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated she was not able to find documented evidence Patient 13 had a disabling dyspnea at rest, was poorly responsive or unresponsive to bronchodilators, had O2 saturation of 88% or less, or was on complete rest and/or confined to bed or chair. b. During a review of Patient 14s demographics indicated a start of care date of 8/15/2023 with a terminal diagnosis of chronic obstructive pulmonary disease with acute exacerbation (an increase in the severity of a problem or illness). During a review of Patient 14’s Re-Cert Assessment, dated 3/19/2024, indicated Patient 14 was awake, alert, oriented x 2 (to person and place), had no cardiac-related pain, regular pulse, had mild to moderate shortness of breath with minimal exertion and with speech, and ambulatory with one person assist. During a review of Patient 14s LCD Hospice Eligibility Determination form for Pulmonary Disease, dated 3/19/2024, indicated Patient 14 was eligible per LCD guidelines. The LCD form indicated section 1 and at least one of the conditions in section 2 should be met. It was marked “yes” in section 1 that Patient 14 had a disabling dyspnea at rest as evidenced by being poorly responsive or unresponsive to bronchodilators, resulting in decreased functional capacity. Section 2 was marked “;yes” that Patient 14 had hypoxia as evidenced by O2 sat less than or equal to 88% determined either by arterial blood gases or O2 sat monitors. During a review of Patient 14’s “Physician Certification for Hospice Benefit” for the 8th benefit period from 4/11/2024 to 6/09/2024, indicated Patient 14 has a life expectancy of six months or less if the terminal illness runs its normal course. The “;Physician Narrative” section did not indicate any supportive evidence Patient 14 met LCD Guidelines for pulmonary disease to continue hospice care and services. During a review of Patient 14’s clinical record indicated there was no documented evidence Patient 14 had a disabling dyspnea at rest, was poorly responsive or unresponsive to bronchodilators, or had O2 saturation of 88% or less. During a joint home visit, on 4/18/2024 at 10:00 a.m. with the Registered Nurse 3 (RN 3) at Patient 14s residence, Patient 14 was observed standing in the living room area, awake, alert, and oriented x 2, had normal breathing, not on oxygen, and had no shortness of breath, accompanied by the patients family member (FM 1). During an interview on 4/18/2024 at 10:25 a.m. with FM 2, FM 2 stated Patient 14 had no episodes of shortness of breath for several months, only used oxygen supplement as needed, breathing treatment using albuterol medication (a bronchodilator) was effective in case patient had shortness of breath, can walk around the house with minimal assistance, and goes to church every Sunday. During an interview on 4/19/2024 at 10:18 a.m. with the DPCS, the DPCS stated the agency used LCD assessment as basis for determining patients eligibility for hospice services. DPCS stated she could not find documented evidence Patient 14 had a disabling dyspnea at rest, was poorly responsive or unresponsive to bronchodilators, had O2 saturation of 88% or less. During a review of the agencys policy and procedure titled “Patient Admission Criteria”, revised June 2019, indicated hospice admits a patient only on the recommendation of the Medical Director in consultation with, or input from the patient’s attending physician. In reaching a decision to certify that the patient is terminally ill, the Medical Director must consider at least the following information: diagnosis of the terminal condition of the patient, other health conditions whether related to or unrelated to the terminal condition, and current clinically relevant information supporting all diagnoses.”

“Based on observation, interview, and record review, the hospice agency failed to ensure the medications and the medication profiles were reviewed and updated, with all the medications the patients were currently taking with the correct doses for one of 23 sampled patients (Patient 8). This deficient practice had the potential to put the patient at risk for medication errors and adverse drug reactions. A review of Patient 8’s “;Face sheet” indicated Patient 8 was admitted to the agency with a start of care date 9/08/2023 with a primary diagnosis of hypertensive heart disease with heart failure (a disease where the blood pressure is high and there heart fails to pump enough blood throughout the body). A review of Patient 8s “;Certification of terminal illness, Certification number 3: Re-certification Statement for Next 60-day period” (CTI) indicated, Patient one was recertified with a primary diagnosis of hypertensive heart disease with heart failure. A review of Patient 8’s “;Plan of Care Summary” (POC) dated 4/09/2024, included an order starting 9/08/2023 for the skilled nursing (SN) services 1-3 times a week and 3 as a week for needed visits for symptom management. A review of Patient 8s “;Current Treatment/Medication/DME List” order date 03/19/2024 indicated “;Calcium Acetate (used to control high blood levels of phosphorus in people with kidney disease who are on dialysis) 667 mg Take one capsule by mouth twice daily.” During a home visit observation on 4/17/2024 at 11:50 a.m., at Patient 8’s home, Patient 8’s calcium acetate label indicated, “;Calcium Acetate 667 milligrams take two capsules by mouth twice daily.” During an Interview on 4/17/2024 at 11:52 a.m. with RN 2, RN 2 stated “;when I go to my patients home, a part of my assessment is always to go over and check all the medications and the medication profile in order not to overdose or underdose the patient, and to make sure that it matches with the orders we have on hand . As seen here for patient 8s order of calcium acetate, our order and the dose order provided by the pharmacy does not match. The one provided by pharmacy is actually double the dose of the one thats in our order. Its correct on the chart, correct on the medication profile and incorrect on the bottle provided by the pharmacy. The nurse that usually visits the patient should have checked the medication bottles to catch this.” During an interview on 4/19/2024 at 10:56 a.m., with DPCS, DPCS stated, “;the order for calcium acetate states 1 mg twice a day.” When asked how often the visiting nurse should do medication reconciliation, DPCS stated, “;On every visit”. During a review of the agencys policy and procedure titled “;Medication Reconciliation”, undated, the policy and procedure indicated, “;Hospice will reconcile patients medications at time of admission and on ongoing basis.””

“Based on interview and record review, the Hospice Agency (HA) failed to ensure to follow the written plan of care (POC) for two of 23 sampled patients (Patient 1 and Patient 8). For Patient 1, the HA did not follow Patient 1’s POC to provide safe transfer, when HA did not provide CNA 1 training to educate on how to provide safe care using the safe transfer/repositioning techniques with the aid of appropriate equipment. For Patient 8, the Skilled Nurse (SN) did not provide wound care treatment to Patient 8’s right 4th finger/lesion. This deficient practice resulted in Patient 1 for an avoidable fall accident and had the potential for Patient 8’s wound not to heal. A review of Patient 1’s demographics (identifying information such as patients name, date of birth and address, along with insurance information) indicated the HA admitted Patient 1 on 9/24/2023, with a diagnoses including atherosclerosis heart disease (build up of fats, cholesterol, and other substances in and on the artery walls) and vascular dementia (brain damage caused by multiple stroke), related weakness and unrelated dependence on wheelchair. During a review of CNA 1’s Employee Personnel Record indicated CNA 1’s certificate was issued on 3/3/2023 and her date of hire at the hospice agency was on 10/2/2023. However, there was no documentation regarding staff orientation or competency checklist found in CNA 1’s personnel file. During a review of Patient 1’s Fall Risk Assessment (a screening tool used to predict patient’s risk of falling) dated 1/9/2024, indicated Patient 1 had two episodes of falls within the last two months, with intermittent confusion, confined to bed/chair, and was assessed as high risk for falls. During a review of Patient 1’s Plan of Care (POC, the process of identifying a patient’s needs to ensure collaboration among nurses, patients, and other healthcare providers) dated 2/13/2024, the POC for Patient 1 indicated an order for the HA (hospice aide) to provide HA to visit twice a week for assistance with activities of daily living. The POC also indicated under the Mobility section related to the limited mobility, due to deleterious effects of immobility associated with the patient’s disease process, had a nursing intervention to educate hospice staff on how to provide safe care using the safe transfer/repositioning techniques with the aid of appropriate equipment. During a review of Patient 1’s “Patient Communication” note dated 2/19/2024, the Patient Communication note indicated that the Registered Nurse 1 (RN1) received a phone call from CNA1 that Patient 1 was being transferred by CNA 1 via wheelchair from the restroom after receiving a bath. Patient 1’s “Patient Communication” note indicated that upon transferring, Patient 1 leaned forward, fell, and hit her head on the floor. Patient 1’s “Patient Communication” note indicated that CNA immediately notified the board and care facility staff regarding the fall incident of Patient 1. During a review of Patient 1’s Incident/Occurrence report dated 2/19/2024, at 11:20 a.m., indicated RN 1 received a phone call from CNA 1 stating Patient 1 was being transferred by her via wheelchair from the restroom after receiving a bath. Upon transferring, Patient 1 leaned forward and fell and the patient hit her head on the floor. On 2/19/2024, at 11:22 a.m., during a phone conversation, RN 1 spoke to the paramedic staff and reported on Patient 1s condition that Patient 1 was assessed having a golf ball size hematoma to the left side of the head. Patient 1 was picked up by the paramedics and was transferred to the nearest GACH for further evaluation. During a review of Patient 1’s computed tomography ( CT scan, to obtain detailed internal images of the body) of the head report dated 2/19/2024, indicated Patient 1 showed a finding of acute subdural hematoma (intracranial bleeding) with midline shift. During a review of Patient 1’s Discharge Summary dated 2/19/2024, indicated Patient 1 was sent to the GACH with the status post fall and large hematoma noted to the left side of the head. During a review of Patient 1’s Medicare Hospice Benefit Revocation sheet dated 2/19/2024, indicated the form was signed by FM 1 revoking Patient 1’s hospice benefit to seek aggressive treatment. During a review of Patient 1’s “Death Certificate”, indicated the patient expired on 3/12/2024, at 12:56 p.m., having an acute cardiopulmonary arrest as the cause of death. During a telephone interview on 4/16/2024, at 10 a.m., with family member 1 (FM 1), FM 1 stated she was upset because of the fall incident that happened on 2/19/2024, that CNA 1 assisted Patient 1 off the shower chair to the wheelchair and fell down hitting her head with no assistance to catch the patient. FM 1 stated twenty days after the fall, the patients health condition worsen, and the fall incident caused the patient’s death on 3/12/2024. During an interview with HRM1 (human resources manager) on 4/17/2024, at 11 a.m., when asked if she provided an orientation and competency assessment for CNA 1 upon hiring, she stated she does not remember if she did one or not. She also stated she could not find any documented evidence that CNA 1 had her orientation and have taken a competency test for her assigned duties as a CNA. During an interview with the DPCS on 4/17/2024, at 12 p.m., she stated among all the CNA staff that the hospice agency have hired, CNA 1 was the only one who was not provided a staff orientation and competency assessment upon her hiring to the agency. The DPCS stated the staff had missed providing safety training on assistance and transferring to CNA 1 before sending CNA 1 out to do patient care to Patient 1 as written in the plan of care. During a review of the agencys undated policy and procedure titled, “;Employee Orientation,” indicated all employee and contracted staff who has patient and family contact would receive an orientation that includes training specific to job requirements. During a review of the agencys undated policy and procedure titled, “Staff Competency Program”, indicated the patient care staff will be completely assessed at defined intervals; for each new employee during orientation and at least every three years. The hospice aides competency will be assessed and observed by an RN (registered nurse). The competency evaluation checklist will be completed and retained in the employee’s record. A review of Patient 8’s “;Face sheet” indicated Patient 8 was admitted to the agency with a start of care date 9/08/2023 with a primary diagnosis of hypertensive heart disease with heart failure (a disease where the blood pressure is high and there heart fails to pump enough blood throughout the body). A review of Patient 8s “;Certification of terminal illness (CTI), Certification number 3: Re-certification Statement for Next 60-day period” (CTI) indicated, Patient 8 was recertified with a primary diagnosis of hypertensive heart disease with heart failure. A review of Patient 8’s “;Plan of Care Summary” (POC) dated 4/09/2024, included an order starting 9/08/2023 for the skilled nursing (SN) services 1-3 times a week and 3 as a week for needed visits for symptom management. The POC indicated Integumentary / Skin, start date 09/08/2023 under Interventions, “;Assess alteration in skin integrity every visit.” A review of Patient 8s “;Physician Orders” dated 09/08/2023 indicated “;Right 4th finger/lesion: Cleanse with NS, pat dry, apply Neosporin (antibacterial ointment) every other day managed by caregiver (CG). Hospice nurse 1x weekly.” During a review of Patient 8’s clinical record from dates 9/11/2023 to 11/21/2023, from 12/5/2023 to 02/14/2024, and from 03/04/2024 to 4/17/2024, there was no documented evidence the license nurse assessed measurements of Patient 8s right 4th finger lesion or performed wound care as ordered by the physician. During an interview on 4/17/2024 at 10:15 a.m., with Registered Nurse 1 (RN 1), when asked if RN 1 performed wound care on Patient 8s lesion on her right 4th finger RN 1 stated, “; not all the time, I did some times. At times I would go to Patient 8s house and the caregiver already did it, so I didnt do it. The caregiver is pretty good about taking care of the wound.” When asked if the lesion on Patient 8s right 4th finger was ever measured, RN 1 stated, “;I did last week.” When asked how often per agency policy are wound assessments and measurements supposed to be done, RN 1 stated, “;Im not sure.” When asked why is it important to do wound measurements, RN 1 stated, “;to track the progression of the wound.” When asked per physician orders how often is the hospice nurse supposed to do wound care, RN 1 stated, “;I think on every visit, I can’t recall.” During a concurrent record review and interview on 4/19/2024 at 11:05 am with Director of Patient Care Services (DPCS) of the nurse visit notes for Patient 8, the DPCS stated, “;the only assessment for patient 8 wound measures are on initial assessment and on recertification fourth lesion was on start of care on 9/8/2023, 11/28/2023 and 2/20/2024 done by RN 1 in the chart.” When asked how often is the visiting nurse supposed to do a complete assessment, including measurements of the wound, the DPCS stated. “;Weekly”. When asked how often the nurse is supposed to provide wound care, DPCS stated, “;the nurse is supposed to follow the physicians prescribed order and frequency.” During a review of the agencys policy and procedure titled “;Wound Care Policy and Procedure”, undated, the policy and procedure indicated, “;Conduct A thorough assessment weekly of the wound during each visit or as indicated by the patient’s condition. Assess wound characteristics including size, depth, appearance, odor, drainage, and surrounding skin integrity.” The policy further indicated, “;document won’t assessment findings, interventions performed, patient response, and any changes in the wound status in the patients electronic health record or paper chart. Record the date, time, and initials of the health care professional performing the wound care procedure. Won’t care per MD order and measurements documented every week.” During a review of the agencys policy and procedure titled “;Physician Orders”, undated, the policy and procedure indicated, “;drugs and treatments are administered by staff only as ordered by physician.””

“Based on interview and record review, the hospice agency (HA) failed to notify the physician regarding the current medical condition for one out of 23 sampled patients, (Patient 1). The HA did not notify the Physician, when Patient 1 had fall accident. This deficient practice had the potential to cause delayed in care and services and further evaluation of Patient 1’s care needs that could affect the quality of end of life care goals. A review of Patient 1’s demographics (identifying information such as patients name, date of birth and address, along with insurance information) indicated the HA admitted Patient 1 on 9/24/2023, with a diagnoses including atherosclerosis heart disease (build up of fats, cholesterol, and other substances in and on the artery walls) and vascular dementia (brain damage caused by multiple stroke), related weakness and unrelated dependence on wheelchair. During a review of Patient 1’s Fall Risk Assessment dated 1/9/2024, indicated Patient 1 had two episodes of falls within the last two months, with intermittent confusion, confined to bed/chair, and was assessed as high risk for falls. During a review of Patient 1’s “Patient Communication” note dated 2/19/2024, Patient 1’s “Patient Communication” note indicated that the Registered Nurse 1 (RN1) received a phone call from CNA 1 stating Patient 1 was being transferred by her via wheelchair from the restroom after receiving a bath. Patient 1’s “Patient Communication” note indicated that upon transferring, Patient 1 leaned forward, fell, and the patient hit her head on the floor. CNA 1 also stated she immediately notified the board and care facility staff regarding the fall incident of Patient 1. During a review of Patient 1’s Incident/Occurrence report dated 2/19/2024, at 11:20 a.m., indicated RN 1 received a phone call from CNA 1 stating Patient 1 was being transferred by her via wheelchair from the restroom after receiving a bath. Patient 1’s Incident/Occurrence report indicated that upon transferring, Patient 1 leaned forward and fell and the patient hit her head on the floor. The Patient 1’s Incident/Occurrence report indicated that on 2/19/2024, at 11:22 a.m., during a phone conversation, RN 1 spoke to the paramedic staff and reported on Patient 1s condition that Patient 1 was assessed having a golf ball size hematoma to the left side of the head. The Patient 1’s Incident/Occurrence report indicated that Patient 1 was picked up by the paramedics and was transferred to the nearest GACH for further evaluation. There was no documented evidence that the physician was notified of Patient 1’s fall incident. During a telephone interview on 4/16/2024, at 10 a.m., with Family Member 1 (FM 1), FM 1 stated she was upset because of the fall incident that happened on 2/19/2024, that CNA 1 assisted Patient 1 off the shower chair to the wheelchair and fell down hitting her head with no assistance to catch the patient. She further stated twenty days after the fall, the patients health condition worsen, and the fall incident caused the patient’s death on 3/12/2024. During an interview with the DPCS on 4/17/2024, at 12 p.m., she stated the HA staff failed to notify the physician regarding Patient 1’s fall incident and there was no documented evidence found to justify that the physician was notified. A review of the facilitys undated policy and procedure titled, “Interdisciplinary Group Coordination of Care,” indicated the interdisciplinary group should maintain responsibility for the provision and coordination of care, regardless of the setting where care is provided to its patient.”

“Based on interview and record review the Hospice Agency (HA) failed to ensure the individualized Plans of Care (POC) was implemented for one of 23 sampled patients (Patient 8). This deficient practice resulted in the physician not aware of the services not being provided to Patient 8 in accordance with the POC. A review of Patient 8’s “;Face sheet” indicated Patient 8 was admitted to the agency with a start of care date 9/08/2023 with a primary diagnoses of hypertensive heart disease with heart failure (a disease where the blood pressure is high and there heart fails to pump enough blood throughout the body). A review of Patient 8s “;Certification of terminal illness, Certification #3: Re-certification Statement for Next 60-day period” (CTI) indicated, Patient one was recertified with a primary diagnoses of hypertensive heart disease with heart failure. A review of Patient 8’s “;Plan of Care Summary” (POC) dated 4/09/2024, included an order starting 9/08/2023 for the skilled nursing (SN) services 1-3 times a week and 3 as a week for needed visits for symptom management. A review of Patient 8s electronic clinical record visit notes there were no license nurse visit notes or missed visit notes recorded for the week of 2/26/2024 to 3/3/2024. During a concurrent interview and record review on 4/18/2024 at 11:34 a.m. with RN 1, of Patient 8s clinical record communication log, there was no communication note found regarding a missed visit in the log for the week of 2/26/2024 to 3/3/2024. RN 1 stated, “;I had a trainee the week of February 26,2024 to March 3, 2024 and I got sidetracked because there were two other emergency patients to see and I never made the visit for patient 8.” When asked if RN 1 notified to office/doctor or document the missed visit, RN 1 stated, “;No, I did not.” During an interview on 4/19/2023 at 10:51 a.m. with DPCS, DPCS stated, “;if there is a missed visit, the RN is responsible is supposed to notify the office, the RN is supposed to notify the family to offer an alternative visit and if a determinative visit is for that day notify the office so we can schedule another nurse to attend and to notify the IDG.” When DPCS asked if RN 1 notified the office or the doctor about the missed visit for the week of 2/26/2024 to 3/3/2024 for patient 8, or provided a missed visit, DPCS stated, “;no RN 1 did not.” During a review of the agencys policy and procedure titled “;Missed Visit Policy for Hospice Care”, undated, the policy and procedure indicated, “;All missed visits will be reported to the immediate supervisor, physician, and family members according to the Hospice Plan of Care.” The policy further indicated, “;1. Notification Requirement: Staff members are required to notify the hospice organization promptly upon becoming aware that they will be unable to fulfill a scheduled visit with a patient. Notification should be made to the appropriate supervisor or designated point of contact. 2. Reason for Missed Visit: Staff members must provide a valid reason for the missed visit, which may include emergencies, illness, transportation issues, or unavoidable scheduling conflicts. Documentation of the reason should be maintained for record-keeping purposes. 3. Rescheduling: Efforts should be made to reschedule missed visits as soon as possible, with priority given to patients with urgent or critical needs. Staff members are responsible for coordinating with the patient and their family to arrange a mutually convenient alternative visit time. 4. Documentation: All missed visits must be documented in the patient’s records, including the reason for the absence and any actions taken to address the situation. Documentation should be accurate, complete, and maintained in accordance with organizational policies and regulatory requirements.”

“Based on interview and record review, the hospice agency (HA) failed to ensure that one of 33 Certified Nursing Assistants (CNA 1) successfully completed competency testing, including safe transfer techniques prior to providing services to one of 23 sampled patients, Patient 1, who was admitted to the facility as high risk for falls by failing to: 1. Ensure Certified Nursing Assistant 1 (CNA1) may not be allowed to provide services to patients independently until the CNA 1 has successfully completed competency testing, including safe transfer techniques either at the HA or at another training facility, and the HA has verified successful completion through documentation provided by the applicant or the training facility. The deficient practice resulted in Patient 1, who was assessed as high risk for fall, was in the shower on 2/19/2024, and CNA 1 assisted the patient off the shower chair to the wheelchair and the patient fell forward and hit her head on the floor and sustained a hematoma (a pool of clotted blood that forms in a organ or issue) on left side of the head. Patient 1 was transferred to a general acute care hospital (GACH) where she was admitted to an intensive care unit (ICU) on 2/19/2024 due to having an acute left sided subdural hematoma caused by the Patient 1s fall incident. Twenty days after the fall, the patients health condition worsen, and Patient 1 passed away on 3/12/2024. On 4/17/2024 at 2:20 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the provider’s non-compliance with one or more requirements of participation has caused, or likely to cause, serious injury, harm impairment, or death to a patient) in the presence of the agencys Administrator and the Director of Patient Care Services (DPCS) related to the hospice agency (HA) failure to ensure that one of 33 Certified Nursing Assistants (CNA) successfully completed competency testing, including safe transfer techniques prior to providing services to Patient 1, who was admitted to the facility as high risk for falls. On 4/19/2024, at 1:50 p.m., the survey team completed the survey tasks, and conducted an exit conference with the Administrator and DPCS with the IJ situation not removed. The HA was informed to submit an acceptable IJ Removal Plan. The HA had not submitted the IJ Removal Plan to the survey team as of 4/19/2024. On 4/22/2024, at 11:53 a.m., the agency submitted an IJ Removal Plan, the survey team reviewed the IJ Removal Plan, and was not acceptable. On 4/22/2024 at 1:24 p.m., the survey team informed the agency that the IJ Removal was not acceptable and to submit an acceptable IJ Removal Plan. A review of Patient 1’s demographics (identifying information such as patients name, date of birth and address, along with insurance information) indicated the HA admitted Patient 1 on 9/24/2023, with a diagnoses including atherosclerosis heart disease (build up of fats, cholesterol, and other substances in and on the artery walls) and vascular dementia (brain damage caused by multiple stroke), related weakness and unrelated dependence on wheelchair. During a review of Patient 1’s Fall Risk Assessment dated 1/9/2024, indicated Patient 1 had two episodes of falls within the last two months, with intermittent confusion, confined to bed/chair, and was assessed as high risk for falls. During a telephone interview on 4/16/2024, at 10 a.m., with FM 1 (family member), FM 1 stated she was upset because of the fall incident that happened on 2/19/2024, that CNA 1 assisted Patient 1 off the shower chair to the wheelchair and fell down hitting her head with no assistance to catch the patient. She further stated twenty days after the fall, the patients health condition worsen, and the fall incident caused the patient’s death on 3/12/2024. During a review of Patient 1’s Patient Communication note dated 2/19/2024, the Patient Communication note indicated that RN 1 (registered nurse) received a phone call from CNA 1 stating Patient 1 was being transferred by her via wheelchair from the rest room after receiving a bath. Upon transferring, Patient 1 leaned forward, fell, and the patient hit her head on the floor. CNA 1 also stated she immediately notified the board and care facility staff regarding the fall incident of Patient 1. During a review of Patient 1’s Incident/Occurrence report dated 2/19/2024, at 11:20 a.m., indicated RN 1 received a phone call from CNA 1 stating Patient 1 was being transferred by her via wheelchair from the rest room after receiving a bath. Upon transferring, Patient 1 leaned forward and fell and the patient hit her head on the floor. On 2/19/2024, at 11:22 a.m., during a phone conversation, RN 1 spoke to the paramedic staff and reported on Patient 1s condition that Patient 1 was assessed having a golf ball size hematoma to the left side of the head. Patient 1 was picked up by the paramedics and was transferred to the nearest GACH for further evaluation. During a review of Patient 1’s CT scan (computed tomography- to obtain detailed internal images of the body) of the head report dated 2/19/2024, indicated Patient 1 showed a finding of acute subdural hematoma (intracranial bleeding) with midline shift. During a review of Patient 1’s “Death Certificate”, indicated the patient expired on 3/12/2024, at 12:56 p.m., having an acute cardiopulmonary arrest as the caused of death. During a review of Patient 1’s Discharge Summary dated 2/19/2024, indicated Patient 1 was sent to the GACH with the status post fall and large hematoma noted to the left side of the head. During a review of Patient 1’s Medicare Hospice Benefit Revocation sheet dated 2/19/2024, indicated the form was signed by FM 1 revoking Patient 1’s hospice benefit to seek aggressive treatment. During a review of Patient 1’s Plan of Care (POC, the process of identifying a patient’s needs to ensure collaboration among nurses, patients, and other healthcare providers) dated 2/13/2024, the POC for Patient 1 indicated an order for the HA (hospice aide) to provide HA to visit twice a week for assistance with activities of daily living. The POC also indicated under the Mobility section related to the limited mobility, due to deleterious effects of immobility associated with the patient’s disease process, had a nursing intervention to educate hospice staff on how to provide safe care using the safe transfer/repositioning techniques with the aid of appropriate equipment. During a review of CNA 1’s Employee Personnel Record indicated CNA 1’s certificate was issued on 3/3/2023 and her date of hire at the hospice agency was on 10/2/2023. However, there was no documentation regarding staff orientation or competency checklist found in CNA 1’s personnel file. During an interview with HRM1 (human resources manager) on 4/17/2024, at 11 a.m., when asked if she provided an orientation and competency assessment for CNA 1 upon hiring, she stated she does not remember if she did one or not. She also stated she could not find any documented evidence that CNA 1 had her orientation and have taken a competency test for her assigned duties as a CNA. During an interview with the DPCS on 4/17/2024, at 12 p.m., she stated among all the CNA staff that the hospice agency have hired, CNA 1 was the only one who was not provided a staff orientation and competency assessment upon her hiring to the agency. The DPCS stated the staff had missed providing safety training on assistance and transferring to CNA 1 before sending CNA 1 out to do patient care to Patient 1. DPCS stated that CNA 1 had resigned from her position on 3/1/2024. During a review of the agencys undated policy and procedure titled, “;Employee Orientation,” indicated all employee and contracted staff who has patient and family contact would receive an orientation that includes training specific to job requirements. During a review of the agencys undated policy and procedure titled, “Staff Competency Program”, indicated the patient care staff will be completely assessed at defined intervals; for each new employee during orientation and at least every three years. The hospice aides competency will be assessed and observed by an RN (registered nurse). The competency evaluation checklist will be completed and retained in the employee’s record.”

“Based on interview and record review the hospice agency (HA) failed to ensure any amendments, correction or late entries within an electronic health record clearly identified the original content, the modified content, date, and authorship of each record modification for one of 19 sampled patients (Patient 8). This deficient practice had the potential to result in an unauthorized and inaccurate patient information or assessment that could affect Patient 8s quality of care and well-being. Findings: During a review of Patient 8’s Face sheet (admission record), the Face Sheet indicated the HA admitted Patient 8 with a start of care date 9/8/2023 with a primary diagnoses of hypertensive heart disease with heart failure (a disease where the blood pressure is high and their heart fails to pump enough blood throughout the body). During a review of Patient 8s undated “;Certification of terminal illness, Certification #3: Re-certification Statement for Next 60-day period” (CTI), the CTI indicated Patient 8 was recertified with a primary diagnoses of hypertensive heart disease with heart failure. During a review of Patient 8’s Plan of Care Summary (POC), dated 4/9/2024, the POC indicated an order starting 9/8/2023 for the skilled nursing (SN) services one to three times a week and three a week for needed visits for symptom management. During a review of Patient 8s Physician Orders, dated 9/8/2023, the Physician Orders indicated “;Right 4th finger/lesion: Cleanse with NS (normal saline-solution to clean a wound), pat dry, apply Neosporin (anti-bacterial ointment) every other day managed by CG (caregiver). Hospice nurse 1x weekly.” During a review of patient 8s electronic medical record from dates 9/11/2023 to 11/21/2023, 12/5/2023 to 2/14/2024, and from 3/4/2024 to 4/17/2024, indicated the licensed nurses (in general) did not assess Patient 8s right 4th finger lesion and did not perform wound care on Patient 8s right 4th finger lesion. During a concurrent interview and record review, on 4/19/2024, at 10:54 am, with the Director of Patient Care Services (DPCS), Patient 8s clinical record was reviewed. The DPCS stated the communicated log indicated, “;4/18/2024 4:00 p.m. RN 1 Comm Note Late entry communication note: Informed Family Member (FAM) on week of Feb 26th through March 1st will be missed and if that was ok. Visit will be resumed next week Wednesday. Informed FAM who communicated back, OK sounds good thank you for letting me know. MD was informed.” DPCS stated, “;RN 1 (Registered Nurse) indicated on the late entry entered on 4/18/2024 at 4 pm missed visit communication note for a patient 8, the medical Director was informed of this missed visit. This is not true. The medical Director was never notified. Thats false documentation.” During a concurrent interview and record review on 4/19/2024, at 11:35 am, with DPCS of patient 8 clinical record, visit note skin assessment from 9/8/2023 to 4/15/2024 DPCS stated, “;it looks like the wound care done by RN 1 since 9/8/2023 to 4/15/2024 is there and she did wound care based on her charting.” During a review of Patient 8s medical record form titled “;Audit log” dated from 9/8/2023 to 4/15/2024, indicated RN 1 accessed and documented in Patient 8s Electronic Medical Record (EMR) on 4/17/2024. During a concurrent interview and record review on 4/19/2024, at 12:02 p.m., the DPCS reviewed Patient 8s record titled, “;Audit Log”, dated 9/8/2023 to 4/15/2024. The DPCS stated the Audit log record indicated RN 1 had made 34 modifications to the document titled Skin Assessment (a document that describes the nursing assessment done on patients skin and any care provided to the skin) from 9/8/2023 to 4/15/2024. The modifications included changes to the narrative, such as changing the previous value of blank to “;Right lateral knee/bump, left open to air. SN performed wound care to right 4th finger lesion per poc (plan of care). No drainage. PT (patient) Tolerated well. PT Has rheumatoid arthritis (a chronic inflammatory disorder usually affecting small joints in the hands and feet) of the upper/lower extremities. Gout with tophi (occurs when uric acid crystals form masses of white growth that develop around the joints and tissues). Charcots feet (a result of nerve damage to the foot)”. The DPCS stated, “;it looks like RN 1 based on this audit log, went back to the start of care 9/8/2023 all the way to 4/15/2024 on every visit note skin assessment and added wound care performed by RN 1 on patient 8s 4th finger lesion, which was not there before. This is willful falsification of records.” During a review of the agencys policy and procedure titled “;Information Accuracy and Truthfulness Policy”, undated, the policy and procedure indicated, “;1. All information provided by employees, including contracted staff, must be accurate and truthful. Such information may be verbal, written or involve electronic submission and/or transmission of data. 2. Hospice requires each employee to engage in the employment process in good faith. Hospice has the right to terminate any employee for failing to participate in good faith by falsifying any information. 3. An employee must never provide Hospice with falsified information during employment. Hospice construes any efforts to do so as a violation of the employee’s obligation to engage in employment in good faith. 4. Falsification is defined as fabrication, in whole or in part, of any information provided by an employee to Hospice. This includes, but is not limited to, any reformatting, redrafting or content deletion of documents, including home care record documentation and billing information.””

“Based on interview and record review the Hospice Agency (HA) failed to ensure contents and information in the patients medical records were safeguarded from unauthorized access by HA staff to make any alterations or modifications for one of 19 sampled patients (Patient 8) This deficient practice had the potential to result in an unauthorized and inaccurate patient information or assessment that could affect Patient 8s quality of care and well-being. Findings: During a review of Patient 8’s Face sheet (admission record), the Face Sheet indicated the HA admitted Patient 8 with a start of care date 9/8/2023 with a primary diagnoses of hypertensive heart disease with heart failure (a disease where the blood pressure is high, and their heart fails to pump enough blood throughout the body). During a review of Patient 8s undated “;Certification of terminal illness, Certification #3: Re-certification Statement for Next 60-day period” (CTI), the CTI indicated Patient 8 was recertified with a primary diagnoses of hypertensive heart disease with heart failure. During a review of Patient 8’s Plan of Care Summary (POC), dated 4/9/2024, the POC indicated an order starting 9/8/2023 for the skilled nursing (SN) services one to three times a week and three a week for needed visits for symptom management. During a review of Patient 8s Physician Orders, dated 9/8/2023, the Physician Orders indicated “;Right 4th finger/lesion: Cleanse with NS (normal saline-solution to clean a wound), pat dry, apply Neosporin (anti-bacterial ointment) every other day managed by CG (caregiver). Hospice nurse 1x weekly.” During a review of Patient 8s medical record form titled “;Audit log” dated from 9/8/2023 to 4/15/2024, indicated RN 1 accessed and documented in Patient 8s Electronic Medical Record (EMR) on 4/17/2024. During a review of patient 8s electronic medical record from dates 9/11/2023 to 11/21/2023, 12/5/2023 to 2/14/2024, and from 3/4/2024 to 4/17/2024, indicated the licensed nurses (in general) did not assess Patient 8s right 4th finger lesion and did not perform wound care on Patient 8s right 4th finger lesion. During a concurrent interview and record review, on 4/19/2024, at 10:54 am, with the Director of Patient Care Services (DPCS), Patient 8s clinical record was reviewed. The DPCS stated the communicated log indicated, “;4/18/2024 4:00 p.m. RN 1 Comm Note Late entry communication note: Informed Family Member (FAM) on week of Feb 26th through March 1st will be missed and if that was ok. Visit will be resumed next week Wednesday. Informed FAM who communicated back, OK sounds good thank you for letting me know. MD was informed.” DPCS stated, “;RN 1 (Registered Nurse) indicated on the late entry entered on 4/18/2024 at 4 pm missed visit communication notes for a patient 8, the medical Director was informed of this missed visit. This is not true. The medical Director was never notified. Thats false documentation.” During a concurrent interview and record review on 4/19/2024 at 11:35 am with DPCS of patient 8 clinical record, visit note skin assessment from 9/8/2023 to 4/15/2024 DPCS stated, “;it looks like the wound care done by RN 1 since 9/8/2023 to 4/15/2024 is there and she did wound care based on her charting.” During a concurrent interview and record review on 4/19/2024, at 12:02 p.m., the DPCS reviewed Patient 8s record titled, “;Audit Log”, dated 9/8/2023 to 4/15/2024. The record indicated RN 1 had made 34 modifications to the document titled Skin Assessment (a document that describes the nursing assessment done on patients skin and any care provided to the skin) from 9/8/2023 to 4/15/2024. The modifications included changes to the narrative, such as changing the previous value of blank to “;Right lateral (side) knee/bump, left open to air. SN performed wound care to right 4th finger lesion per POC (plan of care). No drainage. PT (patient) Tolerated well. PT Has rheumatoid arthritis (a chronic inflammatory disorder usually affecting small joints in the hands and feet) of the upper/lower extremities. Gout with tophi (occurs when uric acid crystals form masses of white growth that develop around the joints and tissues). Charcots feet (a result of nerve damage to the foot)”. The DPCS stated, “;it looks like RN 1 based on this audit log, went back to the start of care 9/8/2023 all the way to 4/15/2024 on every visit note skin assessment and added wound care performed by RN 1 on patient 8s 4th finger lesion, which was not there before. This is willful falsification of records.” During an interview on 4/19/2024 at 12:05 p.m., with DPCS, DPCS stated, “;I was under the impression we had a safeguard in place where nurses or whoever is charting cannot go back and modify their charting after they are submit it and sign. I thought it locks and they cant access it to prevent such things from happening, but it looks like RN 1 was able to go back all the way to 9/8/2023 and modify her visit notes for patient 8. We need to make some adjustments for safeguarding.” During a review of the agencys policy and procedure titled “;Compliance Officer”, undated, the policy and procedure indicated, “;1. The Governing Board has designated the Administrator as the Compliance Officer (CO). The CO assumes responsibility for the design, implementation and daily oversight of the Compliance Program. 2. CO will collaborate directly with the Governing Board and legal counsel to implement “due diligence” activities of Hospice to identify risks for certain types of unlawful or unethical conduct which may occur. Such risk identification will include Medicare and Medicaid fraud and abuse, licensing and compliance requirements. 3. The CO will oversee and participate in defined compliance audits to gain knowledge about: • Existing standards and procedures. • Documentation system. • Day-to-day operations. • Most important applicable legal duties. • Staff orientation, education and training programs. • Communication of the Compliance Program to staff.””