Karen Ann Quinlan Hospice

“It is required that a hospice aide provides services: Ordered by the Interdisciplinary Group; Included in the plan of care; Permitted to be performed under state law and regulation; Consistent with the hospice aide training. THIS IS A CMS CONDTION LEVEL DEFICIENCY This Condition was not met as evidenced by clinical record review, personnel record review, and interview with the Associate Administrator, which revealed the following findings: Failure to ensure the hospice aide received an annual on-site competency assessment in 1 of 2 personnel records reviewed [HSRM.27.D/L632]; Failure to ensure that aide supervision was documented every 14 days in 7 of 14(50%) clinical records [HSRM.25.I/L629]; Failure to ensure the hospice aide received written patient instructions to meet the patient’s needs in 4 of 7 (24%) records [HCDT.15.I/L625]; and failure to ensure the hospice aide successfully completed a competency evaluation prior to providing patient care [HSRM.9.I/L615] in 1 of 2 (50%) personnel records reviewed. The cumulative effect of these systemic problems has resulted in the hospice agency’s inability to ensure the provision of quality health care in a safe environment for the condition of participation 42 CFR 418.76, Hospice aide and homemaker services. The collective deficient practice illustrated systemic process failures that had the potential to affect all patients cared for by the agency.”

“It is required that the hospice maintains an emergency preparedness training program that is based on the emergency preparedness plan, risk assessment, policies and procedures, and the communication plan. The training program is reviewed and updated at least every two (2) years. The hospice EP training program includes the following: For all new hospice employees and those providing services under arrangement, initial training in EP policies and procedures consistent with their expected roles. This standard was not met as evidenced by document review, interview and personnel record review. In 1 of 14 (7%) personnel records reviewed, it was revealed that the agency did not ensure that the volunteer received training in the emergency preparedness plan prior to providing services to patients as per the agency’s policy. POLICY AND PROCEDURES: The agency policy titled, Emergency Operations Plan, (review date 08/2024), stated in part, “All new staff will be oriented and trained to the Emergency Operations Plan.” PERSONNEL RECORD 14: The volunteer was hired 02/21/2024. There was no documented evidence of training on the agency’s Emergency Operations Plan. During an interview with the Volunteer Coordinator on 07/08/2025, she confirmed that this volunteer did not receive training on the agency’s Emergency Operations Plan. She stated that such training is currently not a standard part of the volunteer orientation process.”

“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 10 of 26 (38%) clinical records reviewed, it was revealed that the agency did not ensure that the written plan of care identified planned interventions based on problems identified in the initial and updated comprehensive assessments. CLINICAL RECORD 3: The hospice election of benefit form was dated 07/07/2025 with a primary diagnosis of Bladder Cancer. The patient had two nephrostomy tubes identified on the initial comprehensive assessment, and she was having difficulty with drainage and was asking questions. There were no individualized interventions for the nephrostomy tube on the initial plan of care or updated plans of care. The documented interventions were to assess the ostomy site and instruct on ostomy care. The nurse provided instruction during the home visit on 07/08/2025. The plan of care was not specific to the type of ostomy, and that there were collection bags and the patient had an undergarment to thread the ostomy tubes through to support the tubes and collection bags. CLINICAL RECORD 4: The hospice election of benefit form was dated 07/03/2025 with a primary diagnosis of Sepsis, Bacteremia. The initial nursing comprehensive assessment documented that the patient had a dressing on the left foot and weeping from the right lower extremity. Additionally, the patient had a 16 French Foley catheter to a large bag drainage. The initial plan of care documented that a catheter should be assessed and instructions on care, but was non-specific to the size and drainage, and whether it could be changed or flushed during care. The skin integrity interventions were documented to assess skin integrity, assess pressure ulcer status, and administer wound care as ordered. It was non-specific to the location of wounds, or the care that the wounds required, or the frequency of care. CLINICAL RECORD 9: The hospice election of benefit form was dated 10/10/2024 with a primary diagnosis of pleural effusion. The initial nursing comprehensive assessment documented a Foley catheter 18 French/10cc balloon to a large bag drainage. The initial plan of care was not specific to Foley care; the interventions documented were to assess the catheter for patency and instruct on catheter care. The plan of care did not include the catheter size, frequency of change, or whether the catheter could be flushed during care. CLINICAL RECORD 10: The hospice election of benefit form was dated 01/18/2025 with a primary diagnosis of Bone Cancer. The initial nursing comprehensive assessment documented a Foley catheter 20 French to a large bag drainage. The initial plan of care and plans of care updated every two weeks did not document any interventions for the Foley catheter. CLINICAL RECORD 14: The hospice election of benefit form was dated 03/27/2025 with a primary diagnosis of Lymphatic Cancer. The initial nursing comprehensive assessment documented that the patient had a Foley catheter 18FR/10cc to a large bag drainage. The interventions were not specific to the size of the catheter, whether it could be changed, or whether it could be flushed if problems occurred. There was a physician order written on 06/27/2025 for flushing, and the spouse was instructed on this as documented on the updated nursing assessment, but the plan of care was not updated for these interventions. Additionally, on 06/19/2025, a wound was documented on the updated nursing assessment on the patient’s right heel and coccyx. The interventions documented were to assess the wound and instruct on ordered wound care, but the interventions were non-specific to the location of the wounds, or the frequency of wound care required. CLINICAL RECORD 15: The hospice election of benefit form was dated 06/17/2025 with a primary diagnosis of Rectal Cancer. The initial nursing comprehensive assessment documented that the patient had a colostomy and a urostomy. The initial plan of care and updated plans of care every two weeks were documented to assess the ostomy and to instruct on ostomy care. This was not specific to the type of ostomy, location of ostomies, or care that the ostomies would require. CLINICAL RECORD 17: The hospice election of benefit form was dated 07/02/2025 with a primary diagnosis of Pleural effusion. The initial nursing comprehensive assessment documented a chest tube site that required a dressing of Vaseline gauze and a foam dressing. The initial plan of care did not document any interventions for skin integrity and had not been updated with any interventions for skin care as of review 07/10/2025. CLINICAL RECORD 18: The hospice election of benefit form was dated 05/23/2025 with a primary diagnosis of Senile Dementia. The initial nursing comprehensive assessment documented a wound on the right foot. The care documented was a Medi honey dressing covered by alginate and a dry dressing that the facility cared for. The initial plan of care and updated plans of care did not document any interventions for skin integrity and care, or location for the wound. The paper facility plan, scanned into the record, documented that the facility provided wound care. CLINICAL RECORD 19: The hospice election of benefit form was dated 04/11/2025 with a primary diagnosis of Cancer of the peritoneum. The initial nursing comprehensive assessment documented a draining abdominal wound with a colostomy bag to control drainage. This wound healed by 06/14/2025. There was an updated assessment that documented a stage 2 coccyx wound on 06/14/2025 that required a Mepilex dressing. The initial plan of care and plans of care updated every two weeks were not specific to the wound’s location or care. The interventions documented were to assess skin integrity, reduce skin breakdown, but not specific to the identified wounds or care. CLINICAL RECORD 21: The hospice election of benefit form was dated 06/27/2025 with a primary diagnosis of severe protein malnutrition. The initial nursing comprehensive assessment documented a wound on the left arm that had a dressing. The initial plan of care and plans of care were updated every 2 weeks, documenting interventions to assess the wound and to assess caregiver understanding of wound care, and the caregiver was asked to demonstrate understanding of wound care. The interventions were not specific to the location of the wound or the wound care to be provided. During the interview on 07/11/2025, the Clinical Supervisor reviewed the records and stated that the software limits what they can document on the plans of care.”

“It is required that all hospice aide services must be provided by an individual who has successfully completed one (1) of the four (4) training and competency evaluations programs described below, and the individual furnishes hospice aide services on behalf of a hospice only after successfully completing a competency evaluation program also described below. The hospice maintains documentation that each hospice aide has met the requirements. The competency evaluation addresses each of the following subject areas from item 2; They are evaluated by observation of an aide’s performance with a patient or pseudo-patient, including: Communication skills, including the ability to read, write, and verbally report clinical information to patients, caregivers, and other hospice staff; Reading and recording temperature, pulse, and respiration; Appropriate and safe techniques in performing personal hygiene and grooming tasks, including items on the following basic checklist: Bed bath; Sponge, tub, and shower bath; Hair shampoo (sink, tub, and bed); Nail and skin care; Oral hygiene; Toileting and elimination; Safe transfer techniques and ambulation; Normal range of motion and positioning. This standard was not met as evidenced by interview and personnel record review. In 1 of 2 (50%) certified home health aide (CHHA) personnel records reviewed, it was revealed that the agency did not ensure that the aide successfully completed a competency evaluation prior to providing patient care. PERSONNEL RECORD 7: The CHHA, was hired on 05/20/2024 and provided care within the agency’s inpatient unit. There was no documented evidence of a competency evaluation that was completed at the time of hire with the required observed skills, prior to providing patient care. The first documented evidence of a completed competency evaluation was dated 01/22/2025. The CHHA was a certified hospice aide who had completed an approved certification program. During an interview on 07/10/2025 with the agency’s Associate Administrator, she confirmed that there was no documented evidence of a competency evaluation being completed for this CHHA at time of hire and prior to providing patient care, including outside of the personnel record.”

“It is required that hospice aides are assigned to a specific patient by a registered nurse who is a member of the Interdisciplinary Group. Written patient care instructions for a hospice aide are prepared by a RN who is responsible for the supervision of the hospice aide. This standard was not met as evidenced by clinical record review and interview. In 4 of 17 (24%) clinical records reviewed, in which a hospice aide was accepted, it was revealed that the agency did not ensure that the hospice aide received written patient instructions to meet the patient’s needs. CLINICAL RECORD 4: The hospice election of benefit form was dated 07/03/2025 with a primary diagnosis of Sepsis Bacteremia. The initial comprehensive assessment documented that the patient had an indwelling catheter and that there was a Mepilex dressing on the coccyx. The hospice aide plan, dated 07/05/2025, included the task of total bed bath and oral hygiene. Review on 07/09/2025, the aide plan did not include a task for Foley care or the specific instruction for management of the dressing on the coccyx during bathing. Aide visits were documented on 07/06/2025 and 07/07/2025. CLINICAL RECORD 5: The hospice election of benefit form was dated 12/20/2024 with a primary diagnosis of Senile Degeneration. The hospice aide plan was dated 03/009/2025 and the next update was documented on 06/07/2025. The aide visit frequency was 5 times a week. with assigned tasks of bed bath, oral hygiene, soak feet every visit, and lotion skin every visit. The initial nursing comprehensive assessment documented on 12/20/2024 documented that the patient had a splint with an Ace wrap on the right lower extremity and a foam dressing over a wound on the left leg. There was no specific direction for the aide on what to do to manage the dressings during bathing and soaking of the foot. CLINICAL RECORD 6: The hospice election of benefit form was dated 05/21/2025 with a primary diagnosis of Parkinson’s Disease. The initial nursing comprehensive assessment documented that the patient could not be left alone, and the son was to be present for all visits. The aide plan was dated 06/11/2025 with an aide frequency of 2 times a week. The assigned bath was a sponge bath every visit and a shower every visit, with no defined decision maker (sponge bath vs shower) as of the review date 7/9/2025. CLINICAL RECORD 18: The hospice election of benefit form was dated 05/25/2025 with a primary diagnosis of Senile Degeneration. The initial nursing comprehensive assessment documented that the patient had a dressing on the right foot. The hospice aide plan was dated 05/27/2025 with no updates, included bathing task of bed bath every visit, but no specific instructions for how to manage the dressing on the foot if it was saturated or fell off. The hospice aide frequency was 7 times a week. During the interview with the Management team on 07/10/2024, they reviewed the records and stated that not all the directions were specific in the aide plans.”

“It is required that hospice aides are supervised by a registered nurse who makes 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 ensure that services ordered by the hospice Interdisciplinary Group (IDG) meet the patient’s need. The hospice aide does not need to be present. This standard was not met as evidenced by clinical record review and interview. In 7 of 14 (50%) clinical records reviewed, in which a hospice aide was accepted and provided care for greater than 14 days, it was revealed that the agency did not ensure that the Hospice Aide was supervised every 14 days as required. CLINICAL RECORD 1: The hospice election of benefit form was dated 05/06/2025 with a primary diagnosis of Cervical Cancer. Aide supervision was documented on 06/05/2025, then 06/19/2025, which was 14 days, then an LPN (licensed practical nurse) made a visit, and the next RN (registered nurse) visit was 07/08/2025, which was day 19 and 5 days late. CLINICAL RECORD 5: The hospice election of benefit form was dated 12/20/2024 with a primary diagnosis of Senile Degeneration. The first hospice aide visit was 12/11/2024. Supervision was documented 12/26/2024, then 01/16/225, which was day 20 and 6 days late, then 01/31/2025, which was day 15 and 1 day late. Additionally, Aide supervision was documented 04/01/2025 and 04/16/2025, the next was documented on 05/31/2025, which was 44 days and missed several 14-day reviews. The election benefit of periods reviewed were 12/10/2024 - 03/09/2024, and03/10/2025 - 06/07/2025 CLINICAL RECORD 6: The hospice election of benefit form was dated 05/21/2025 with a primary diagnosis of Parkinson’s Disease. The first hospice aide visit was dated 06/11/2025 with a frequency of 2 times a week. No supervision was documented as of the last nursing visit dated 7/2/2025 which would be 21 days, and missing a 14-day supervision CLINICAL RECORD 7: The hospice election of benefit form was dated 03/29/2024 with a primary diagnosis of Congestive Heart Failure. The hospice aide visit frequency was 5 times a week. Aide supervision was documented on 11/12/2024, and no supervision was documented as of live discharge 01/13/2025. This was 62 days and missed 4 fourteen-day supervisions. CLINICAL RECORD 13: The hospice election of benefit form was dated 04/15/2025 with a primary diagnosis of Congestive Heart Failure. The first hospice aide visit was 04/18/2025 with a frequency of 4 times a week. As of review on 07/02/2025, no supervision had been documented since the first aide visit. This was 68 days and missed 4 fourteen-day supervisions. CLINICAL RECORD 22: The hospice election of benefit form was dated 05/21/2025 with a primary diagnosis of Bladder Cancer. The first hospice aide visit was 06/07/2025 with a visit frequency of 2 times a week. There was no supervision documented as of 07/02/2025. This was 25 days and missed a fourteen-day supervision. CLINICAL RECORD 23: The hospice election of benefit form was dated 05/08/2025 with a primary diagnosis of Senile Dementia. The first hospice aide visit was 5/16/2025 with a visit frequency of 3 times a week. No supervision was documented as of 07/02/2025, which was 47 days. This missed 3 fourteen fourteen-day supervisions. During the interview with the management team on 07/09/2025, reviewed the records and stated that every 14-day supervision was not documented.”

“It is required that a registered nurse makes an annual on-site visit to the location where a patient is receiving care in order to observe and assess each hospice aide while he or she is performing care per the hospice’s policies and procedures. This standard was not met as evidenced by interview and personnel record review. In 1 of 2 (50%) personnel records reviewed of certified home health aides (CHHA), it was revealed that the agency did not ensure that the CHHA received an annual on-site visit to observe and assess the CHHA’s provision of patient care. PERSONNEL RECORD 2: The CHHA was hired 06/03/2024. There was no documented evidence of an on-site competency assessment completed by a registered nurse within the year that the CHHA was hired. The last documented competency evaluation in the personnel record was dated 05/13/2024, which had been administered by the agency as part of CHHA training provided by the agency immediately prior to hire. During an interview with the Associate Administrator on 07/10/2025, she stated that no additional evidence of a competency evaluation for this CHHA was available, including outside of the personnel record.”

“It is required that the hospice assesses the skills and competencies of all individuals providing care, including volunteers. This standard was not met as evidenced by document review, interview and personnel record review. In 3 of 11 (27%) personnel records reviewed it was revealed that the agency did not ensure that annual competency evaluations were preformed per agency policy. POLICY AND PROCEDURES: The agency policy titled, Proficiency Assessment, (reviewed October 2024) stated, “All paraprofessional and professional staff providing patient care shall have clinical proficiency evaluations performed on hire, at three months, and annually to assess their basic skill levels.” PERSONNEL RECORD 4: The social worker was hired 05/07/1999. There was no documented evidence of annual competency assessments since the agency’s last comprehensive survey in July of 2022. There was a missing annual competency evaluation for the calendar years 2023, and 2024. PERSONNEL RECORD 5: The chaplain was hired 06/12/2023. There was no documented evidence of a completed competency assessment upon hire or annually. PERSONNEL RECORD 6: The registered nurse was hired 06/22/2020. There was no documented evidence of competency assessment since the agency’s last comprehensive survey in July of 2022. Documented annual competency evaluations were missing for the calendar years 2023, 2024. During an interview with the Associate Administrator on 07/10/2025, she stated that there was no documented evidence of additional annual competency evaluations outside of the personnel records.”

“It is required that the clinical patient record, its content, and the information it contains is safeguarded against loss or unauthorized use and must be in compliance with the Department’s rules regarding personal health information as set out at 45 CFR parts 160 and 164. The hospice addresses: Leaving and protecting patient record information in the home; Prevention of physical or electronic altering of the patient record. The hospice complies with state and federal law and regulation addressing privacy, including the Health Insurance and Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH). This standard was not met as evidenced by document review, interview and observation. During a tour of the inpatient unit (IPU) and an interview with clinical staff, it was revealed that the agency did not ensure that personal health information was protected from unauthorized access. POLICY AND PROCEDURES: The agency policy titled, Patient Privacy Rights, (approved October 2024) stated in part, “The agency implements policies and procedures to accommodate patient privacy rights as required by and specified in the Privacy Rule of the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996.” IPU TOUR: During the tour of the IPU on 07/09/2025, a certified home health aide (CHHA) logbook, which was a closed standard-sized three-ring binder without any structure to prevent opening, was observed on a table in a public area where families were observed to gather. Interview: During an interview on 07/10/2025 with a certified home health aide (CHHA, PR#7) who provided care within the IPU, he confirmed that the logbook, which he had used to reference patient care plans and log the care that he had provided, was routinely kept either on the table in the public seating area or at the nursing station. Interview 4: During an interview during the IPU tour on 07/09/2025 with the Associate Administrator, she confirmed that the logbook did contain patient names and other personal identifiable information and was accessible for unauthorized access. She did move the book to the nursing station at that time. A tour of the inpatient unit (IPU) and an interview with clinical staff revealed that the agency did not ensure that personal health information was protected from unauthorized access.”

“It is required that a hospice-operated inpatient care facility complies with all applicable federal, state and local health and safety codes, including the Health Care Facilities Code NFPA 99, 2012 edition. This standard was not met as evidenced by document review, interview and observation. Observation revealed that the hospice-operated inpatient care facility did not ensure compliance with all applicable federal health and safety codes. During a tour of the hospice inpatient unit (IPU) on 07/09/2025, a propane-powered generator was observed as the source of emergency power for the IPU. There was no evidence that the generator and associated equipment was capable of supplying service within 10 seconds. Review of the hospice generator maintenance logs revealed that the time between activating the generator and the provision of emergency power to the IPU was not tracked or recorded on the logs. There was no evidence the 10-second criterion was met during the monthly test, or annual process. During an interview on 07/09/2025, the IPU Facility Manager stated that the generator takes 25 to 35 seconds to supply emergency power to the IPU. The delay is due to the time it takes for the propane to prime the engine. This cannot be changed without replacing the entire generator which would be extremely burdensome to the agency. The Manager also stated that the IPU oxygen concentrators and essential equipment/electronics are equipped with battery back-up to accommodate the delay. There was no evidence of a CMS waiver for specific provisions of the Health Care Facilities Code. A tour of the agency’s inpatient unit (IPU) on 07/09/2025 revealed that the agency did not ensure that the generator and associated equipment were capable of providing emergency power within 10 seconds.”

“It is required that a hospice-operated inpatient care facility complies with all applicable federal, state and local health and safety codes, including the Health Care Facilities Code NFPA 99, 2012 edition. This standard was not met as evidenced by interview and observation. Observation of the hospice-operated in-patient care facility revealed the hospice did not ensure compliance with all applicable federal health and safety codes. The agency policy, Home for Hospice Environment (approved on 10/25/2024), stated in part, “The facility and its contents, including all surfaces and mechanical systems, shall be clean to sight and touch and free of dirt and debris and in sound working order.” There was no evidence that hospice policy and procedure addressed NFPA 99, 2012 edition, 10.5.3, for testing, maintenance and use of electrical equipment. During a tour of the hospice in-patient unit (IPU) on 07/09/2025, oxygen concentrators were observed in all occupied and unoccupied patient rooms. During an interview on 07/09/2025, the IPU Facility Manager stated that the concentrators in the patient rooms were received from a Durable Medical Equipment (DME) vendor on a “rent to own” basis. The concentrators stay in the room and are available for consecutive patient use. The Facility Manager confirmed that oxygen is available through a central piped supply. However, oxygen is primarily supplied to patients via oxygen concentrators. There was no evidence of oxygen concentrator manufacturer manuals. There was no evidence of testing and maintenance of oxygen concentrators according to manufacturer guidelines. During an interview, the Facility Manager stated there was no maintenance process/program in place to test the concentrators between patient use, and there was no access to electronic or paper copies of manufacturer manuals for instruction of use and maintenance/testing. A tour of the agency’s inpatient unit (IPU) on 07/09/2025 revealed that the agency did not ensure that maintenance of oxygen concentrators occurred as recommended by the equipment’s manufacturer.”