Every finding on record at Tropical Health Hospice of Georgia

It is required that each patient’s individualized written plan of care identifies planned interventions based on problems identified in the initial and updated comprehensive assessments. This standard was not met as evidenced by clinical record review and interview. In 1 of 14 (7%) clinical records reviewed, the agency did not ensure the plan of care included planned interventions based on problems identified in the initial and updated comprehensive assessments. CLINICAL RECORD 10: The patient elected the hospice benefit on 12/30/2024 with a terminal diagnosis of senile degeneration of the brain. The initial comprehensive assessment dated 12/30/2024 included documentation that the patient was experiencing constipation. The plan of care dated 12/30/2024 to 02/05/2025 did not include interventions related to the patient’s constipation. During an interview on 02/05/2026 with the Executive Vice President (EVP) and the Hospice Medical Director, it was stated that the patient's family used homeopathic interventions to address constipation. The EVP stated that there was a learning curve with the nurse understanding how to add interventions to the plan of care, and the RN (Registered Nurse) staff would be re-educated to make sure the plan of care included interventions for problems that were noted in the assessments.

It is required that hospice volunteers provide day-to-day administrative or direct patient care services in an amount that, at a minimum, equals five percent (5%) of the total patient care hours of all paid hospice employees and contract staff. This standard was not met as evidenced by document review and interview. The agency did not ensure hospice volunteers provide day-to-day administrative or direct patient care services in an amount that, at a minimum, equals five percent of the total patient care hours of all paid hospice employees and contract staff. A joint review of the agency report titled "Hospice Volunteer Requirement Report" with the Executive Vice President and the Volunteer Coordinator on 02/04/2026 revealed that the volunteer utilization was 2.441% for the year of 2025, which did not meet the requirement of five percent of the total patient care hours of all paid hospice employees and contract staff. During an interview on 02/04/2026, the Volunteer Coordinator and the Executive Vice President stated that it had been challenging to recruit volunteers because of the unique culture in the community and stated many people were resistant to get involved. The agency had initiated a performance improvement project to re-build the volunteer program. A joint review of the agency report titled "Hospice Volunteer Requirement Report" with the Executive Vice President and the Volunteer Coordinator on 02/04/2026 revealed that the volunteer utilization was 2.441% for the year of 2025, which did not meet the requirement of five percent (5%) of the total patient care hours of all paid hospice employees and contract staff.

It is required that if a patient revokes the election of hospice care or is discharged from hospice per hospice regulation §418.26 (i.e., no longer terminally ill), the hospice forwards to the patient’s attending physician a copy of the hospice discharge summary. This standard was not met as evidenced by clinical record review and interview. In 1 of 2 (50%) clinical records reviewed with patient live discharge, the agency did not forward a copy of the hospice discharge summary to the patient’s attending physician. CLINICAL RECORD 12: The patient elected the hospice benefit on 09/03/2024 with a terminal diagnosis of chronic obstructive pulmonary disease. The patient was discharged on 03/02/2025 for extended prognosis greater than 6 months. Clinical record review revealed no documented evidence that the attending physician was forwarded a copy of the hospice discharge summary. During an interview on 02/04/2026 with the Executive Vice President and the Administrator, it was stated that after an extensive review of the clinical record, there was no documentation that the discharge summary was sent to the attending physician.

Based on document review, policy review, and interview, the hospice agency did not provide patients or the patient's representative with the correct information for filing a complaint with the Centers for Medicare and Medicaid Services (CMS). This had the potential to affect the nine current hospice patients receiving services from the agency. --- Findings include: Review of unused new admission documents prepared in advance of an admission revealed the following: 1. A blank form titled, "Hospice Medicare Benefit Election Form," which included information on the patient's right to choose an attending physician and the right to request "Patient Notification of Hospice Non-Covered items, Services, and Drugs, showed, "... As a Medicare hospice beneficiary, you have the right to contact the Beneficiary and Family-Centered Care Quality Organization (BFCC-QIO) to request Immediate Advocacy if you disagree with any of the hospice's determinations. The BFCC-QIO that services your area is: ..." The statement included a name and phone number. 2. A form titled, "Patient and Family Rights," which showed, "Complaint may be reported to the State Hotline 24 hours a day at 404-657-5726 or 404-651-5728 [phone numbers in the state of Georgia]. The website address for the Healthcare Facility Regulation Division at www.dch.georgia.gov." Review of the admission binder during a visit to the home of Patient (P)5 revealed P5 had been given information to call the Chief Executive Officer (CEO) located in the State of Georgia or the Executive Vice President located at the office in St. Thomas with any concerns or complaints. In addition, documentation in the binder included the name of a person at the CMS office in Austin, Texas, and a phone number if the patient or the patient's representative felt the complaint was not addressed adequately. Review of an undated agency policy titled, "Complaint Resolution/Grievance Procedure," revealed, "The availability and use of this grievance procedure does not prevent a person from filing a complaint of discrimination on the basis of disability with the Office for Civil Rights. The Office of Civil Rights is a different place to file a grievance [The policy provides the address for the U.S. Department of Health and Human Services in Atlanta, Georgia.] ... If the response or resolution is unsatisfactory, the State of Georgia maintains a free 800 number for unresolved grievances (800-326-0291) or grievances can be made to the state online at www.ors.dhr.georgia.gov. During an interview on 06/09/23 at 4:15 PM, the Administrator confirmed the agency was not aware of the correct information for filing a complaint to provide to a patient and the patient's representative if they felt the concern was not adequately addressed by the agency.

Based on record review, policy review, and interview, the agency failed to develop an individualized Plan of Care (POC) based on the assessment for nine of nine patients (Patient (P)1, P2, P3, P4, P5, P6, P7, P8, and P9). The failure to develop a plan of care based on the assessment information had the potential to affect the care and safety of all hospice patients receiving services from the agency. --- Findings include: 1. Review of P1's "Hospice Initial/Comprehensive Nursing Assessment" located in the patient's medical binder revealed a start of care (SOC) date of 12/1/22 and the primary hospice diagnosis was listed as "CVA [Cerebrovascular accident]/Stroke." In addition, the document revealed P1 had dementia, a suprapubic catheter (a surgically created connection between the urinary bladder and the skin used to drain urine from the bladder) and two pressure ulcers - one on the sacrum measuring 10 centimeters (cm) length by 8 cm wide by 5 cm deep and a second on the left hip measuring 4 cm length by 2 cm wide by 1 cm deep. P1 died on 12/06/22. The POC section of the "Hospice Initial/Comprehensive Nursing Assessment" labelled "Orders for Discipline and Treatments" showed skilled nursing visit frequency as two times a month, Aide visit frequency as three times a week, Social Worker one time a month, and Spiritual Care one time a month. 2. Review of P2's "Hospice Initial/Comprehensive Nursing Assessment" located in the patient's medical binder revealed a SOC date of 01/16/23 and the primary hospice diagnosis was listed as End Stage CHF (Congestive Heart Failure). In addition, P2 had a history of Diabetes, Hypertension, seizures, and multiple open wounds on both legs identified as pressure ulcers. P2 revoked hospice care on 05/18/23 after the primary caregiver called 911 and P1 was admitted to the hospital via the emergency department seeking medical treatment. The POC section labelled "Orders for Discipline and Treatments" showed skilled nursing visit frequency as two times a month, Aide visit frequency as three times a week, Social Worker one time a month, and Spiritual Care one time a month. 3. Review of P3's "Hospice Initial/Comprehensive Nursing Assessment" located in the patient's medical binder revealed a SOC date of 08/21/22 and the primary hospice diagnosis was listed as Alzheimer's disease. The POC section labelled "Orders for Discipline and Treatments" showed skilled nursing visit frequency as two times a month, Social Worker one time a month, and Spiritual Care one time a month. 4. Review of P4's "Hospice Initial/Comprehensive Nursing Assessment" located in the patient's medical binder revealed a SOC date of 10/18/21 and the primary hospice diagnosis was listed as Alzheimer's disease. The section labelled "Orders for Discipline and Treatments" showed skilled nursing visit frequency as two times a month, Aide visit frequency as three times a week, Social Worker one time a month, and Spiritual Care one time a month. 5. Review of P5's "Hospice Initial/Comprehensive Nursing Assessment" located in the patient's medical binder revealed a SOC date of 10/18/21 and the primary hospice diagnosis was listed as multiple CVA's. The POC section labelled "Orders for Discipline and Treatments" showed skilled nursing visit frequency as two times a month, Aide visit frequency as three times a week, Social Worker one time a month, and Spiritual Care one time a month. 6. Review of P6's "Hospice Initial/Comprehensive Nursing Assessment" located in the patient's medical binder revealed a SOC date of 10/24/22 and the primary hospice diagnosis was listed as Alzheimer's. The POC section labelled "Orders for Discipline and Treatments" showed skilled nursing visit frequency as two times a month, Aide visit frequency as three times a week, Social Worker one time a month, and Spiritual Care one time a month. 7. Review of P7's "Hospice Initial/Comprehensive Nursing Assessment" located in the patient's medical binder revealed a SOC date of 09/03/22 and the primary hospice diagnosis was listed as Alzheimer's. Additional diagnosis included rhabdomyolysis (damaged muscle tissue release proteins and electrolytes into the blood which can damage the heart and kidneys and cause permanent disability or death), failure to thrive, and repeated falls. The POC section labelled "Orders for Discipline and Treatments" showed skilled nursing visit frequency as two times a month, Aide visit frequency as three times a week, Social Worker one time a month, and Spiritual Care one time a month. 8. Review of P8's "Hospice Initial/Comprehensive Nursing Assessment" located in the patient's medical binder revealed a SOC date of 06/21/22 and the primary hospice diagnosis was listed as dementia. The POC section labelled "Orders for Discipline and Treatments" showed skilled nursing visit frequency as two times a month, Aide visit frequency as three times a week, Social Worker one time a month, and Spiritual Care one time a month. 9. Review of P9's "Hospice Initial/Comprehensive Nursing Assessment" located in the patient's medical binder revealed a SOC date of 09/06/22 and the primary hospice diagnosis was listed as senile degeneration of the brain. In addition, P9 had a pressure ulcer on the sacral area and heels of both feet. P9 died on 11/28/22. The POC section labelled "Orders for Discipline and Treatments" showed skilled nursing visit frequency as two times a month, Aide visit frequency as three times a week, Social Worker one time a month, and Spiritual Care one time a month. Review of an undated agency policy titled, "Plan of Care" revealed, "In order to assure that care provided is appropriately planned to meet each patient's specific needs and problems, Hospice will utilize data/information gathered during the comprehensive assessment, updates to the comprehensive assessment and reassessment, in the care planning process to provide care that is consistent with the patient and family needs with the patient's needs and goals as a priority." During an interview on 06/09/23 at 9:00 AM, the Administrator was asked why all patients admitted had the same visit frequency in the POC regardless of the data in the assessment. The Administrator stated, "Because they told us it had to be every 14 days." The Administrator did not clarify who told the agency the frequency had to be every 14 days.

It is required that the hospice Interdisciplinary Group, in consultation with the individual's attending physician (if any), completes an initial comprehensive assessment no later than five (5) calendar days after the election of hospice care, in accordance with CMS §418.24–the elements of the hospice care election statement. This standard was not met as evidenced by clinical record review, document review and interview. I of 11 (9%) clinical records reviewed revealed the interdisciplinary team did not complete the initial comprehensive assessment visit within 5 calendar days after the election of hospice care. Agency policy stated in part, "The hospice interdisciplinary group will complete an initial comprehensive assessment no later than five calendar days after the election of hospice." Clinical Record 9: The patient was admitted to hospice services on 12/6/2022 with a diagnosis of CVA/Stroke. The patient expired on 12/12/2022. On 12/12/2022 the Chaplain documented the patient expired before the Chaplain's initial assessment was completed. In a joint review of the clinical record and interview on 3/22/2023, the clinical program director confirmed that the Chaplain initial comprehensive assessment was never completed for the patient. Agency policy states in part "the hospice interdisciplinary group will complete an initial comprehensive assessment no later than five calendar days after the election of hospice." In a joint review of the clinical record and interview with the clinical program director it was confirmed that the Chaplain initial comprehensive assessment was never made for the patient.

It is required that the documented comprehensive assessment includes a drug profile that contains the patient's current prescription and over-the-counter (OTC) drugs, supplements, herbal remedies and other alternative treatments that could affect drug therapy. The medication review process includes the identification of the following: the effectiveness of drug therapy, drug side effects, actual or potential drug interactions, duplicate drug therapy, and drug therapy associated with laboratory monitoring. The drug profile is updated per agency policy and at a minimum, at the time of each comprehensive assessment and/or when a new medication is added, or changes are made to an existing medication. This standard was not met as evidenced by clinical record review, document review and interview. 4 of 11 (36%) clinical records reviewed revealed that the medication profile was not updated according to agency policy and the medication review process did not include all required components. Agency policy stated in part, "The medication profile will be updated to include any added or changed medications taken by the patient including OTC, supplements, herbal remedies or any other alternative treatments." Clinical Record 1: The patient was admitted to hospice services on 6/21/2022 with a diagnosis of Senile degeneration of the brain. In the RN assessment dated 2/8/2023 it was documented that the patient was taking Tylenol Extra Strength as needed for pain management. It was also documented in the assessment that the patient was using over the counter menthol ointment for lower back pain. These medications were not documented on the patient's medication profile. The clinical record documentation did not include evidence that the agency medication review included a review of the effectiveness of drug therapy, drug side effects, actual or potential drug interactions, duplicate drug therapy, and drug therapy associated with laboratory monitoring. Clinical Record 2: The patient was admitted to hospice services on 6/20/2022 with a diagnosis of Stroke. On 1/25/2023 the RN documented that the patient's eye drops had been changed on 1/13/2023. The change in the prescription for the administration of eye drops was not documented on the medication profile. On 2/8/2023 the RN documented that the patient was given Tylenol Extra Strength for pain management. This medication was not documented on the patient's medication profile. The clinical record documentation did not include evidence that the agency medication review included a review of the effectiveness of drug therapy, drug side effects, actual or potential drug interactions, duplicate drug therapy; and drug therapy associated with laboratory monitoring. Clinical Record 8: The patient was admitted to hospice services on 10/24/2022 with a diagnosis of Alzheimer's disease unspecified. On visits made by the aide on 3/8/20223 and 3/15/2023 it was documented that the patient was using Zinc ointment and Desitin cream for skin protection. These over-the-counter medications were not documented on the medication profile. Clinical Record 6: The patient was admitted to hospice services on 4/24/2022 with a diagnosis of Alzheimer's Disease. On a visit made by the aide on 3/6/2023 it was documented that A&D ointment was being used for skin barrier protection. This over-the-counter medication was not documented on the medication profile. In an interview during joint clinical record review on 3/22/2023, the program clinical director confirmed that the agency did not ensure that the medication profiles were updated. Agency policy states in part "the medication profile will be updated to include any added or changed medications taken by the patient including OTC, supplements, herbal remedies or any other alternative treatments." In joint review of clinical records and interview with program clinical director it was confirmed that the agency did not make updates to the medication profile appropriately.

It is required that the comprehensive assessment includes an initial bereavement assessment of the needs of the patient's family and other individuals, focusing on the social, spiritual, and cultural factors that may impact their ability to cope with the patient's death. Information gathered from the initial bereavement assessment is incorporated into the plan of care and considered in the bereavement plan of care. This standard was not met as evidenced by clinical record review and interview. 2 of 11 (18%) clinical records reviewed revealed the agency did not complete an initial bereavement risk assessment with the patient/family. Clinical Record 9: The patient was admitted to hospice services on 12/6/2022 with a diagnosis of CVA/stroke. A spiritual assessment was completed by the RN on the initial admission visit. There was no documented evidence that an initial bereavement risk assessment was completed. The Chaplain documented on 12/12/2022 that the patient expired before the bereavement risk assessment was completed. Clinical Record 5: The patient was admitted to hospice services on 9/17/2022 with a diagnosis of Olivopontocerebellar atrophy and collapse. The initial spiritual assessment was completed by the Chaplain in a timely manner, but the clinical record did not include evidence that an initial bereavement assess was completed or documented. In an interview during joint clinical record review, the Clinical Program Manager verified this finding and confirmed the clinical record did not include an initial bereavement assessment. In an interview on 3/23/2023, the Chaplain stated it was the agency's policy for the Interdisciplinary Group (IDG) to complete an initial bereavement assessment on every admission and to identify the needs of the patient family and their ability to cope with the patient's death. it is required that an initial bereavement risk assessment be completed by the interdisciplinary group to identify needs of the patient family and ability to cope with the patient's death. In an interview with the Chaplain, she stated that it is the agency's practice to complete this assessment on every admission.

It is required that counseling services include an organized program for providing bereavement services delivered by or under the supervision of a qualified professional with experience or education in grief or loss counseling. Bereavement services are available to the family and other individuals up to one (1) year following the death of the patient. Bereavement counseling extends to residents of a SNF/NF (skilled nursing facility/nursing facility) or ICF/IDF (intermediate care facility/intellectual disability facility) when appropriate and identified in the bereavement plan of care. The bereavement services reflect the needs of the bereaved per a bereavement plan of care that includes: 1. The types of bereavement services to be offered; 2. The frequency of service delivery. This standard was not met as evidenced by clinical record review, document review and interview. I of 3 (33%) applicable clinical records reviewed revealed the agency did not ensure that bereavement care was provided to the family after the patient's death. Agency policy stated in part, "Bereavement care will be provided for all patient families for at least 1 year following the patient's death." In an interview on 3/29/23, the Bereavement Coordinator stated all families/bereaved receive phone calls and/or letters at time of patient's death, 1 month, 3 months, 6 months, 9 months and 12 months. If needed these families are also referred to community bereavement support groups or counseling. Clinical Record 11: Patient elected hospice services on 3/17/2022 and was admitted with a diagnosis of Malignant neoplasm of abdomen. The patient expired on 3/27/2022. During the initial assessment completed by the Chaplain on 3/18/2022, the family refused chaplain services. An initial bereavement risk assessment was completed at that time which revealed a high-risk score of 26. The clinical record did not include evidence that bereavement care was provided to the patient's family after the death of the patient. During joint review of the clinical record and interview on 3/29/23, the Program Director confirmed that no bereavement care was provided after patient expired. The Bereavement Coordinator and Program Director both stated that the family was called after the patient's death, and they refused any further support which was not documented. Agency policy states in part "bereavement care will be provided for all patient families for at least 1 year following the patient's death." In an interview with the bereavement coordinator, it was stated that all patients receive phone calls and/or letters at time of patient's death, 1 month, 3 months, 6 months, 9 months and 12 months. If needed these families are also referred to community bereavement support groups or counseling.

It is required that a patient clinical record containing past and current findings is maintained for each hospice patient. The record contains correct clinical information that is available to the patient’s attending physician and hospice staff. The record may be maintained electronically or on paper. Each patient’s record includes, at a minimum, physician orders. This standard was not met as evidenced by clinical record review and interview. 2 of 11 (18%) clinical records reviewed revealed the hospice did not ensure the clinical record included physicians’ orders for care provided. Clinical Record 8: The patient was admitted to hospice services on 10/24/2022 with a diagnosis of Alzheimer's disease unspecified. On visits made by the aide on 3/8/20223 and 3/15/2023 it was documented that the patient was using Zinc ointment and Desitin cream for skin protection. In an interview on 3/22/2023, the clinical program director confirmed that there was no order written by the physician for the use of these products. Clinical Record 6: The patient was admitted to hospice services on 4/24/2022 with a diagnosis of Alzheimer's Disease. On a visit made by the aide on 3/6/2023 it was documented that A&D ointment was being used for skin barrier protection. In an interview during joint clinical record review on 3/22/2023, the clinical program director confirmed there was no order written by the physician for the use of this product.

It is required that a hospice may contract for durable medical equipment services with a Medicare-certified DME point-of-service (POS) supplier that meets the CMS DMEPOS Supplier Quality and Accreditation standards and has a letter verifying that the DMEPOS supplier is accredited by a recognized accreditation organization. This standard was not met as evidenced by document review and interview. In an interview with the Administrator and Clinical Program director it was found that the hospice does not receive durable medical equipment from a Medicare-certified DME point-of-service (POS) supplier that meets the CMS DMEPOS Supplier Quality and Accreditation standards and does not have a letter verifying that the DMEPOS supplier is accredited by a recognized accreditation organization. The Island is very small and has limited resources when choosing pharmacy or DME company. There is one company on the Island that supplies DME, and this company is not accredited by a recognized accreditation organization or any other organization. In an interview with the Administrator and Clinical Program director it was found that the hospice does not have receive durable medical equipment from a CMS DMEPOS supplier, The Island of St. Thomas is very small and has limited resources when choosing pharmacy or DME company. There is one company on the Island that supplies DME and this company is not accredited by a recognized accreditation organization or any other organization,

Upon observation, there was no evidence the hospice complies with all applicable federal, state, and local emergency preparedness requirements by establishing and maintaining an emergency preparedness program that meets the requirements of 42 CFR 418.113. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence the Emergency Preparedness plan: • Is based on and includes a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach • Includes strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence the The Emergency Preparedness plan addresses patient population, including, but not limited to: • The type of services the hospice has • The ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans The agency was not able to provide proof of compliance during the survey.

Upon policy and procedure review, the agency did not provide policies for review to determine if policy and procedures described the hospice must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in standard HSP7-4B and the communication plan in standard HSP7-4C. The policies and procedures must be reviewed and updated every two years.

Upon policy and procedure review, the agency did not provide policies for review to determine if policy and procedures defined procedures to follow up with on duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The hospice must inform state and local officials of any on-duty staff and patients that they are unable to contact.

Upon policy and procedure review, the agency did not provide policies for review to determine if policy and procedures defined the procedures to inform state and local officials about hospice patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment.

Upon policy and procedure review, the agency did not provide policies for review to determine if policy and procedures defined a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains the availability of records.

Upon policy and procedure review, the agency did not provide policies for review to determine if policy and procedures defined the process for the use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of state and federally designed health care professionals to address surge needs during an emergency.

Upon policy and procedure review, the agency did not provide policies for review to determine if policy and procedures defined the development of arrangements with other hospices and other providers to receive patients in the event of limitations or cessation of operations to maintain the continuity of services to hospice patients.

Upon observation, there was no evidence the hospice develops and maintains an emergency preparedness communication plan that complies with federal, state, and local laws and must be reviewed and updated every two years. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence of emergency preparedness training and testing program that is based on the emergency plan, policies and procedures and the communication plan. The agency was not able to provide proof of compliance during the survey.

Upon personnel record review, 4 of 12 (Personnel #5,#7,#8,#9) did not have evidence Emergency Preparedness training including: • Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles • Demonstrate staff knowledge of emergency procedures • Provide emergency preparedness training at least annually • Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others • Maintain documentation of all emergency preparedness training Personnel 5,7,8,9: The agency was unable to provide the personnel files for review during the survey.

Upon observation, there was no evidence the agency has conducted exercises to test the emergency plan every two years. The agency was not able to provide proof of compliance during the survey.

Upon patient record review, 1 of 11 (Patient #10) did not have evidence that the patient chooses a health care provider, including an attending physician. Patient 10: The medical record contained an election of benefit form with choice of a community attending physician. There was no evidence of collaboration with the attending physician for development of plan of care.

Condition of Participation: Initial and Comprehensive Assessment of the Patient.

Upon patient record review 1 of 11 (Patient #7) did not have evidence in the patient record that the comprehensive assessment identifies 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. Patient 7: There was no evidence of a psychosocial assessment included as part of the comprehensive assessment.

Upon patient record review, 5 of 11 (Patients #1,#2,#5,#6,#10) did not have evidence in the patient record that a review was completed of all prescription and non-prescription medications, including herbal remedies that could affect drug therapy. Patient 1: The medical record contained nursing documentation upon recertification 2/16/23 identifying patient use of an oxygen concentrator. There was no evidence of oxygen listed on the medication profile. Patient 2: The medication profile contained Dulcolax with no dosage. Corrected on site. Patient 5: The medication profile contained Senna PRN with no frequency, Cavilon topical cream with no area defined for administration, dorzolamide and latanoprost eyedrops with no amount of drops to instill, and Metamucil oral powder with no instructions for a diluent. Corrected on site. Patient 6: The medication profile contained medication with frequencies not defined, stating as directed for Centrum Silver, magnesium, vitamin D, vitamin D3, vitamin E, glucosamine, Prevagen, vitamin B complex with C, dandelion root, saw palmetto, and nettle extract. Patient 10: The medication profile contained ondansetron, prednisone, and senokot PRN with no frequencies defined. The medication profile contained Aleve as directed PRN with no frequency, miconazole nitrate PRN with no route or frequency, dulcolax as directed PRN with no dose or frequency, and Biofreeze and Little Miracle topical creams for pain relief PRN no defined locations for administration.

Upon patient record review, 5 of 11 (Patients #1,#4,#5,#6,#7) did not have evidence in the patient record that the comprehensive assessment is updated including and by: • The hospice interdisciplinary group (in collaboration with the individual's attending physician, if any) • Changes that have taken place since the initial assessment • Information on the patient's progress toward desired outcomes • Reassessment of the patient's response to care • The assessment update must be accomplished as frequently as the condition of the patient requires, but no less frequently than every 15 days Patient 1: There was no evidence of an RN visit completed between 11/1/22 and11/25/22. Also no evidence of an update to the comprehensive assessment during this time. Patient 4: There was no evidence of an RN visit completed between 11/2/22 and11/28/22. Also no evidence of an update to the comprehensive assessment during this time. Patient 5: There was no evidence of an RN visit completed between 11/2/22 and 11/28/22, and 1/23/23 to 2/17/23. Also no evidence of an update to the comprehensive assessment during this time. Patient 6: There was no evidence of an RN visit completed between 1/9/23 and 2/2/23 and no visits after 2/9/23 to 3/2/23. Also no evidence of an update to the comprehensive assessment during this time. Patient 7: There was no evidence of an RN visit completed between 1/9/23 and 2/6/23, and 2/6/23 and 2/28/23. Also no evidence of an update to the comprehensive assessment during this time.

Condition of Participation: Interdisciplinary Group, Care Planning, and Coordination of Services. L536

Upon patient record review, 11 of 11 (Patients #1,#2,#3,#4,#5,#6,#7,#8,#9,#10,#11) did not have evidence the plan of care must includes all services necessary for the palliation and management of the terminal illness and related conditions, including the following: • A detailed statement of the scope and frequency of services necessary to meet the specific patient and family needs • The IDG demonstrates a proactive approach in developing each patient's plan of care by planning ahead for anticipated patient changes and needs. Decisions should reflect the patient/family preferences rather than be solely a response to a crisis. Patient 1: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN, and social worker once monthly PRN. There was no evidence of a quantity of PRN visits allowable within a defined timeframe. Patient 2: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN, and social worker once monthly PRN. There was no evidence of a quantity of PRN visits allowable within a defined timeframe. Patient 3: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN, and social worker once monthly PRN. There was no evidence of a quantity of PRN visits allowable within a defined timeframe. Patient 4: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN, and social worker once monthly PRN. There was no evidence of a quantity of PRN visits allowable within a defined timeframe. Patient 5: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN, and social worker once monthly PRN. There was no evidence of a quantity of PRN visits allowable within a defined timeframe. Patient 6: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN per family request, social worker once monthly PRN per family request. There was no evidence of a quantity of PRN visits allowable within a defined timeframe. Patient 7: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN, and social worker once monthly PRN. There was no evidence of a quantity of PRN visits allowable within a defined timeframe. Patient 8: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN, and social worker once monthly PRN. There was no evidence of a quantity of PRN visits allowable within a defined timeframe. Patient 9: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN, and social worker once monthly PRN. There was no evidence of a quantity of PRN visits allowable within a defined timeframe. Patient 10: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN, and social worker once monthly PRN. There was no evidence of a quantity of PRN visits allowable within a defined timeframe. Patient 11: The medical record contained an order for frequencies written nurse twice monthly PRN as needed, chaplain once monthly PRN, and social worker once monthly PRN. There was no evidence of a quantity of PRN visits allowable within a defined timeframe.

Upon patient record review, 5 of 11 (Patients #1,#2,#5,#6,#10) 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 1: The medical record contained nursing documentation upon recertification 2/16/23 identifying patient had an oxygen concentrator. There was no evidence of an order for oxygen. Patient 2: The medical record contained an order for Dulcolax with no dosage, corrected on site. Patient 5: The medical record contained orders for Senna PRN with no frequency, Cavilon topical cream with no area defined for administration, dorzolamide and latanoprost eyedrops with no amount of drops to distill, and Metamucil oral powder with no instructions for a diluent. Corrected on site. Patient 6: The medical record contained orders with frequencies not defined, stating as directed for Centrum Silver, magnesium, vitamin D, vitamin D3, vitamin E, glucosamine, Prevagen, vitamin B complex with C, dandelion root, saw palmetto, and nettle extract. Patient 10: The medical record contained orders for ondansetron, prednisone, and senokot PRN with no frequencies defined. The medication profile contained Aleve as directed PRN with no frequency, miconazole nitrate PRN with no route or frequency, dulcolax as directed PRN with no dose or frequency, and Biofreeze and Little Miracle topical creams for pain relief PRN no defined locations for administration.

Upon patient record review, 8 of 11 (Patients #1,#2,#3,#4,#5,#6,#7,#9) 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 1: The medical record contained nursing documentation upon RN recertification assessment 2/16/23 identifying patient use of shower bench, APAP/BIPAP, crutches, geri-chair, oxygen concentrator, and wheelchair. There was no evidence of orders or the DME included on the plan of care. Patient 2: The medical record contained nursing documentation upon admission identifying patient use of hospital bed, wheelchair, walker, cane, and commode. There was no evidence of orders or the DME included on the plan of care. Patient 3: The medical record contained nursing documentation upon RN recertification assessment 1/21/23 identifying patient use of wheelchair and hospital bed. There was no evidence of orders or the DME included on the plan of care. Patient 4: The medical record contained nursing documentation upon RN recertification assessment 2/28/23 identifying patient use of a shower bench. There was no evidence of orders or the DME included on the plan of care. Patient 5: The medical record contained nursing documentation upon RN recertification assessment 2/17/23 identifying patient use of a shower bench, chair lift, hospital bed, and wheelchair. There was no evidence of orders or the DME included on the plan of care. Patient 6: The medical record contained nursing documentation upon RN recertification assessment 1/24/23 identifying patient use of a shower bench, cane, table, and raised toilet seat. There was no evidence of orders or the DME included on the plan of care. Patient 7: The medical record contained nursing documentation upon RN recertification assessment 1/1/23 identifying patient use of hospital bed, wheelchair, table, and specialty mattress. There was no evidence of orders or the DME included on the plan of care. Patient 9: The medical record contained nursing documentation upon admission identifying patient use of a hospital bed. There was no evidence of orders or the DME included on the plan of care.

Upon client record review, 1 of 11 (Patient #6) did not have evidence that the IDG ensures that the care and services are provided in accordance with the plan of care. Patient 6: The medical record contained an order for chaplain once monthly PRN per family request. There was no evidence of chaplain visits completed from 3/19/22 to 1/20/23.

Condition of Participation: Infection Control.

Condition of Participation: Quality Assessment and Performance Improvement.

Upon observation, there was no evidence the organization develops, implements, and maintains an effective, on-going, organization wide Quality Assessment and Performance Improvement (QAPI) program. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence the board of directors/governing body approves the frequency and detail of the data collection. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence of involvement of the governing body and organizational leaders in the Quality Assessment/Performance Improvement (QAPI) program. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence the hospice's governing body is responsible for ensuring that the hospice-wide Quality Assessment and Performance Improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence the hospice ensures the implementation of a hospice wide Quality Assessment/Performance Improvement (QAPI) program by the designation of a person responsible for coordinating QAPI activities. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence the hospice maintains and documents an effective infection control program that protects patients, families, visitors, and hospice personnel by preventing and controlling infections and communicable diseases. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence the hospice follows acceptable standards of practice to prevent the transmission of infections and communicable diseases, including standard precautions. During the patient home visit for Patient 7, the CNA obtained vitals and did not wash or sanitize hands between glove changes or sanitize the inside of the blood pressure cuff prior to putting it into her bag with other clean equipment.

Upon observation, there was no evidence in QAPI reports that the hospice maintains 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 hospice's Quality Assessment and Performance Improvement program. The agency was not able to provide proof of compliance during the survey.

Condition of Participation: Core Services.

Upon personnel record review, 3 of 12 (Personnel #5, 7, 8) did not have evidence that the hospice routinely provide substantially all core services directly by hospice personnel (The hospice issues a W-2 form for the employee). These services include: • Physician services (may contract for physician services) • Nursing • Medical social services • Counseling The agency did not provide these personnel files.

Upon patient record review, 2 of 11 (Patients #8,#9) did not have evidence the hospice offers bereavement counseling that includes: • Making bereavement services available to the family and other individuals in the bereavement plan of care up to 1 year following the death of the patient. • Ensuring that bereavement services reflect the needs of the bereaved • Development of a bereavement plan of care that notes the kind of bereavement services to be offered and the frequency of service delivery Patient 8: The bereavement care plan provided by the agency contained a list of optional interventions with boxes optional for selection. There was no evidence of a personalized bereavement care plan developed based on the needs of the bereavement. Patient 9: The bereavement care plan provided by the agency contained a list of optional interventions with boxes optional for selection. There was no evidence of a personalized bereavement care plan developed based on the needs of the bereavement.

Upon personnel record review, 1 of 12 (Personnel #5) did not have evidence that Nutritional counseling services are provided by qualified personnel in accordance with applicable laws, regulations and recognized professional practice standards. Personnel 5: The agency was unable to provide the personnel file for review during the survey.

Condition of Participation: Hospice Aide and Homemaker Services. L607

Upon patient record review, 9 of 11 (Patients #1,#2,#3,#5,#7,#8,#9,#10,#11) 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: The aide care plan contained task to clean/file nails three times weekly PRN. Patient 2: The aide care plan contained task to change bed linens three times weekly PRN. Patient 3: The aide care plan contained task to change bed linens three times weekly PRN. Patient 5: The aide care plan contained task to change bed linens three times weekly PRN. Patient 7: The aide care plan contained tasks to clean/file nails and to change bed linens three times weekly PRN. Patient 8: The aide care plan contained tasks to shower three times weekly if patient can and complete bed bath three times weekly PRN. Patient 9: The aide care plan contained task to change bed linens three times weekly PRN. Patient 10: The aide care plan contained task to change bed linens three times weekly PRN. Patient 11: The aide care plan contained task to change bed linens twice times weekly PRN and to shampoo once weekly PRN.

Upon patient record review 6 of 11 (Patients #1,#2,#3,#5,#8,#11) did not have evidence documentation in the patient record that a hospice aide provides services that are: • Ordered by the interdisciplinary group • Included in the plan of care • Permitted to be performed under state law by such hospice aide • Consistent with the hospice aide training Patient 1: The medical record contained aide documentation stating oxygen saturation obtained. There was no evidence of the nurse assigning task on the aide care plan. Patient 2: The medical record contained aide documentation stating oxygen saturation obtained. There was no evidence of the nurse assigning task on the aide care plan. Patient 3: The medical record contained aide documentation stating oxygen saturation obtained. There was no evidence of the nurse assigning task on the aide care plan. Patient 5: The medical record contained aide documentation identifying use of a Hoyer lift for transfers. There was no evidence of the nurse assigning instructions for use of a Hoyer lift for transfers on the aide care plan. Patient 8: The medical record contained aide documentation stating oxygen saturation obtained. There was no evidence of the nurse assigning task on the aide care plan. Patient 11: The medical record contained aide documentation stating oxygen saturation obtained. There was no evidence of the nurse assigning task on the aide care plan.

Upon patient record review 1 of 11 (Patient #11) did not have evidence documentation in the patient record that a Registered Nurse made an on-site visit to the patient's home no less frequently than every 14 days to assess the quality of care and services provided by the hospice aide and to ensure that services ordered by the hospice interdisciplinary group meet the patient's needs. Patient 11: The medical record contained supervisory visits signed but no questions on form were answered for evidence of evaluation 11/8/22, 11/22/22, and 12/6/22.

Conditions of Participation - Volunteers. L641

Upon personnel record review, 1 of 12 (Personnel #7) did not have evidence the individual who supervises volunteers is qualified by meeting the hospice's policies and procedures and/or job description criteria and is a designated hospice employee. Personnel 7: The agency was unable to provide the personnel file for review during the survey.

Upon observation, there was no evidence the hospice maintains, documents and provides volunteer orientation and training that is consistent with hospice industry standards. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence volunteers are used in day to day administrative and/or direct patient care roles. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence the hospice documents and demonstrates viable and ongoing efforts to recruit and retain volunteers. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence the hospice documented the cost savings achieved through the use of volunteers. Documentation must include the following: • The identification of each position that is occupied by a volunteer • The work time spent by volunteers occupying those positions • Estimates of the dollar costs that the hospice would have incurred if paid employees occupied the positions identified in paragraph (d)(1) of CFR 418.78 for the amount of time specified in paragraph (d)(2) of CFR 418.78 The agency was not able to provide proof of compliance during the survey.

Condition of Participation: Organization and Administration of Services.

Upon observation, there was no evidence BOD/governing body minutes reflect the involvement in the hospice's management and administration of its resources to provide hospice services to patients and families. The agency was not able to provide proof of compliance during the survey.

Upon observation, there was no evidence the hospice is directed by a Board of Directors/governing body which assumes full legal authority and responsibility for the operation of the hospice. The agency was not able to provide proof of compliance during the survey. The administrator did not provide several items to be reviewed during the survey including: several personnel records, emergency preparedness, governing body, QAPI program, infection control program, policies were not provided to review, volunteer program, and COVID-19 policies.

Upon personnel record review, 4 of 12 (Personnel #5,#7,#8,#9) did not have evidence the hospice employees and contract employees have received orientation on the hospice philosophy. Personnel 5,7,8,9: The agency was unable to provide the personnel files for review during the survey.

Upon personnel record review, 4 of 12 (Personnel #5,#7,#8,#9) did not have evidence that a skills competency assessment, specific to each discipline had been conducted for all personnel including volunteers initially during orientation. Personnel 5,7,8,9: The agency was unable to provide the personnel files for review during the survey.

Upon patient record review, 3 of 11 (Patients #1,#6,#7) did not have evidence that before the recertification period for each patient, the medical director or physician designee must review the patient's clinical information and provide written documentation that it is anticipated that the patient's life expectancy is 6 months or less. Patient 1: The certification of terminal illness for the benefit period 9/18/22-12/16/22 is unclear with dates originally written 9/20/22-12/18/22. The 9/20/22 date was stricken through with no initials for correction and 9/18/22 written above, and the 12/18/22 was written over to attempt clarification to 12/16/22 remaining unclear. The certification of terminal illness for benefit period 12/17/22-2/14/23 undeterminable if 12/19/22 or 12/17/22. Patient 6: The certification of terminal illness for benefit period 7/29/22-9/26/22 states for benefit period 7/30/22-9/2/22. The certification of terminal illness for benefit periods starting 7/28/22 and 9/25/22 have a portion of the document for recognition when an NP completes a face to face that is filled out by the RN by mistake. Patient 7: The certification of terminal illness for benefit period starting 9/4/22 states the face to face was completed by the medical director 11/2/22. There was no evidence in the medical record of a face to face completed timely.

Upon patient client record review, 1 of 11 (Patient #10) did not have evidence that each patient record contains Physician certification and recertification of terminal illness. Patient 10: There was no evidence of an initial certification of terminal illness from the attending physician. The medical director signed both sections for medical director and attending physician on the form despite patient election of a community physician on the election form.

Upon policy and procedure review, the agency did not provide policies for review to determine if policy and procedures described if the hospice discontinues operation, hospice policies and procedures must provide for retention and storage of clinical records. The hospice must inform its State Agency and its CMS Regional Office where such clinical records will be stored and how they may be accessed.

Upon client record review, 2 of 11 (Patients #10,#11) did not have evidence that if a patient revokes the election of hospice care or is discharged from hospice in accordance with §418.26, the hospice must forward to the patient's attending physician: • A copy of the hospice discharge summary • The patient's clinical record, if requested Patient 10: There was no evidence of a discharge summary and communication with an attending physician for continuity of care after revocation. Patient 11: There was no evidence of a discharge summary and communication with an attending physician for continuity of care after revocation.

Upon client record review, 2 of 11 (Patients #10,#11) did not have evidence that the discharge summary includes all required information. Patient 10: There was no evidence of a discharge summary. Patient 11: There was no evidence of a discharge summary.

Upon policy and procedure review, the agency did not provide policies for review to determine if policy and procedures defined the process established for the disposal of controlled drugs that are maintained in the patient's home. Policies and procedures include: • Safe use and disposal of controlled drugs in the patient's home • A process for disposing of controlled drugs when the drugs are no longer needed by the patient

Condition of Participation: Personnel Qualifications.

Upon personnel record review, 6 of 12 (Personnel #5,#7,#8,#9,#11,#12) did not have evidence that personnel credentialing activities are conducted to verify qualifications of all credentialed/licensed personnel in the positions they hold at the time of hire, at renewal or in accordance with specific state practice act requirements. Personnel 5,7,8,9,11,12: The agency was unable to provide the personnel files for review during the survey.

Upon personnel record review, 1 of 12 (Personnel #7) did not have evidence that all Medical Social Services are provided by a qualified Medical Social Worker in accordance with the state's Social Work Practice Act, the hospice's policies and procedures and/or job descriptions. Personnel 7: The agency was unable to provide the personnel file for review during the survey.

Upon personnel record review, 1 of 12 (Personnel #12) did not have evidence that all Speech Therapy Services are provided by a qualified licensed Speech-Language Pathologist (SLP) or Audiologist in accordance with the state's Speech-Language Pathology Practice Act and the hospice's policies and procedures and/or job descriptions. Personnel 12: The agency was unable to provide the personnel file for review during the survey.

Upon personnel record review, 1 of 12 (Personnel #11) did not have evidence all Occupational Therapy Services are provided by a qualified licensed Occupational Therapist (OT) in accordance with the state's Occupational Therapy Practice Act and the hospice's policies and procedures and/or job descriptions. Personnel 11: The agency was unable to provide the personnel file for review during the survey.

Upon personnel record review, 1 of 12 (Personnel #5) did not have evidence in the personnel files that if no state licensing, certification or registration requirements exist for personnel qualifications for a Registered Nurse or Licensed Practical Nurse. The following requirements must be met for a: • Registered Nurse – A graduate of a school of professional nursing Personnel 5: The agency was unable to provide the personnel files for review during the survey.

Upon personnel record review, 4 of 12 (Personnel #4,#10,#11,#12) did not have evidence the hospice obtained a criminal background check on all contracted individuals who have direct patient care and access to patient records. Personnel 4,10: There was no evidence of a criminal background check in the personnel files. Personnel 11,12: The agency was unable to provide the personnel files for review during the survey.

Upon personnel record review, 4 of 12 (Personnel #5,#7,#8,#9) did not have evidence of criminal background checks being obtained in accordance with state requirements. In the absence of state requirements, criminal background checks are obtained within three months of the date of employment for all states that the individual has lived or worked in the past 3 years. Personnel 5,7,8,9: The agency was unable to provide the personnel files for review during the survey.

Upon observation, there was no evidence the organizational chart matches the hospice's information submitted to CMS and/or State licensing agencies for ownership and management personnel. The agency was not able to provide proof of compliance during the survey.

Upon policy and procedure review, the agency did not provide policies for review to determine if the Hospice has developed written policies and procedures to ensure that all personnel are fully vaccinated for COVID19. The policies and procedures include, at a minimum, the following components: • A process for ensuring all personnel specified in 42 CFR 418.600(d)(1) (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of 42 CFR 418.600(d)(1), or those personnel for whom COVID-19 vaccination must be temporarily delayed, as recommended by CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to personnel providing any care, treatment, or other services for the Hospice and/or its patients; • A process for ensuring that all personnel specified in 42 CFR 418.600(d)(1) are fully vaccinated, except for those personnel who have been granted exemptions to the vaccination requirements of 42 CFR 418.600(d)(1) or those personnel for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations. • A process for ensuring the implementation of additional precautions, intended to mitigate the transmission, and spread of COVID-19, for all personnel who are not fully vaccinated for COVID-19. • A process for tracking and securely documenting the COVID-19 vaccination status of all personnel specified in 42 CFR 418.600(d)(1). • A process for tracking and securely documenting the COVID-19 vaccination status of any personnel who have obtained any booster doses as recommended by CDC. • A process by which personnel may request an exemption from the personnel COVID-19 vaccination requirements based on an applicable federal law. • A process for tracking and securely documenting information provided by those personnel who have requested, and for whom the Hospice has granted, an exemption from the personnel COVID-19 vaccination requirements. • A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines, and which supports personnel requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable state and local laws, and for further ensuring that such documentation contains: • All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the personnel member to receive and the recognized clinical reasons for the contraindications; and • A statement by the authenticating practitioner recommending that the personnel member be exempted from the Hospice's COVID-19 vaccination requirements for personnel based on the recognized clinical contraindications. • A process for ensuring the tracking and secure documentation of the vaccination status of personnel for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and • Contingency plans for personnel who are not fully vaccinated for COVID-19.