Regal Home Health Services

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, “Organizations” under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF’s emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This Standard is not met as evidenced by: Based on record review and interview the agency failed to document initial and ongoing training for the Emergency Preparedness Program per agency policy in 6 of 7 (A-F) employee files reviewed. Findings include: Review of agency policy titled “Emergency Preparedness Program” revealed in part, “...training is completed annually.” Review of employee A’s file with a date of hire (DOH) of 08/21/2015 revealed a document titled “Annual In-Service Log” dated 2023 had no documentation that Emergency Preparedness Program training was completed. Review of employee B’s file with a DOH of 05/28/2015 revealed a document titled “Annual In-Service Log” dated 2023 had no documentation that Emergency Preparedness Program training was completed. Review of employee C’s file with a DOH of 05/11/2003 revealed a document titled “Annual In-Service Log” dated 2023 had no documentation that Emergency Preparedness Program training was completed. Review of employee D’s file with a DOH of 02/01/2017 revealed a document titled “Annual In-Service Log” dated 2023 had no documentation that Emergency Preparedness Program training was completed. Review of employee E’s file with a DOH of 02/25/2014 revealed a document titled “Annual In-Service Log” dated 2023 had no documentation that Emergency Preparedness Program training was completed. Review of employee F’s file with a DOH of 07/13/2021 revealed no document titled “Annual In-Service Log” dated 2023 and had no documentation that Emergency Preparedness Program training was completed. During an interview with Administrator H and President I on 06/04/2024 at 1:30 PM President I and Administrator H confirmed that the training was not documented/included on the “Annual In-Service Log” document.”

“Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA’s governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-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; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This Standard is not met as evidenced by: Based on record review and interview the agency failed to have the Governing Body review program annually in 1 of 1 Quality Assessment and Performance Improvement (QAPI) programs reviewed. Findings include: Review of agency policy tilted “Quality Assurance and Performance Improvement (QAPI) Plan and Program” last revised in 02/2024 under heading, “Responsibility/Accountability” revealed, “1. The Governing Body is ultimately responsible for an ongoing QAPI and patient safety program that is defined, implemented and maintained.” Review of agency Governing Body meeting minutes dated 12/22/2023 revealed no documentation of having discussed/reviewed the QAPI program. During an interview with Administrator H on 06/04/2024 at 12:00 PM, Administrator H stated that the QAPI program is reviewed “annually” by the Governing Body.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, interview and record review, the agency staff failed to adhere to infection prevention practices related to handwashing, gloving, and bag practices in 3 of 3 home visit observations (Patient # 1, 2 and 3) for a total of 7 patient records reviewed. A visit was conducted 6/4/2023 at 10:00 a.m. at the home of Patient #1 to observe LPN (Licensed Practical Nurse) A assess Patient #1’s blood glucose and administer insulin. During the visit, there were two instances of LPN A not performing hand hygiene prior to entering the nursing bag. Record review of Patient #2’s “Home Health Plan of Care and Certification” with start of care 11/13/2020 and certification period 04/26/2024 to 06/24/2024 revealed Patient #2’s primary diagnosis Type 2 Diabetes Mellitus with Hyperglycemia. During an observation of a home visit with LPN B for Patient #2 on 06/04/2024 from 8:15 AM to 8:39 AM, LPN B donned gloves, applied alcohol swab to Patient #2’s finger, obtained a blood sample with a lancet (a sharp cutting type instrument used to puncture skin for drainage or blood sampling or small incisions), placed blood drop on Patient #2’s glucometer (device for blood sugar readings), and disposed of lancet into sharps container. Using the same gloves, LPN B applied an alcohol swab to Patient #2’s left upper arm, dosed a pre-medicated insulin pen, and injected Patient #2 with the needle device at the end of the insulin pen. The needle was disposed into the sharps container. Using the same gloves, LPN B went into the nursing bag to retrieve a blood pressure cuff, thermometer, and oximeter, assessed Patient #2’s vital signs, then removed gloves and performed hand hygiene. LPN B did not change gloves or perform hand hygiene per policy while moving between clean and dirty tasks. Findings include: Review of agency policy titled, “Hand Hygiene Policy and Compliance Program” revealed in part,” Procedure: Indications for staff performing hand hygiene are: Before and after each procedure. Before and after direct patient contact. After any contact with contaminated materials. Before re-entering nursing bag or patients cleaning supplies.”. Additionally, agency policy states” IV. Use of Gloves: A. Gloves are not a substitute for hand hygiene”. Observation on 06/04/2023 at 11:35 AM of RN (Registered Nurse) C in patients # 3’s home revealed, RN C removed thermometer, blood pressure cuff and stethoscope from nursing bag. RN C applied gloves assessed Patient #3’s vital signs and placed items back into the nursing bag without disinfecting each item. RN C checked pulses on feet then removed medication from patient #3 medication box into gloved hand, without changing gloves or performing hand hygiene between each task. The findings for patients #1, #2, and #3 were reviewed during an interview with Administrator H and President I on 06/04/2024 at 1:20 PM which confirmed staff should be performing glove changes, hand hygiene and clean of equipment per policy.”

“Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This Element is not met as evidenced by: Based on record review and interview the agency staff failed to provide services as ordered for 2 of 7 (#4 & #5) patient records reviewed. Review of Patient #5’s medical record revealed Patient #5 was admitted to service on 2/29/2024 with a primary diagnosis of lymphedema. Secondary diagnoses included venous insufficiency and non-pressure chronic ulcers of lower legs. Review of Patient #5’s “Home Health Plan of Care and Certification” revealed in part, “Order: Skilled Nursing frequency and duration: 2 W 9 (twice per week for 9 weeks). Order: Observation and Assessment of Wound Healing Status, Measure Wound(s) Weekly.” Review of Patient #5’s medical record revealed a wound assessment, including wound measurements, was completed on 4/26/2024. The next wound assessment, including measurements was completed on 5/18/2024. There was no documentation of a wound assessment having been completed for 3 weeks. During an interview with Administrator H on 06/04/2024 at 1:30 PM, Administrator H stated that measurements are expected to be done with the wound assessment and that “the nurses know they need to do it (measure wounds).” Administrator H confirmed the above findings. Findings include: Review of agency policy titled, “Plan of Care-CMS #485 and Physician/Practitioners orders” revised 02/2024 under heading “Procedure” revealed, “20. Care and services provided will be provided according to physician/practitioner orders. Orders are current and updated.” Review of Patient #4’s medical record revealed Patient #4 was admitted to service on 1/6/2024 with a primary diagnosis of pressure ulcer of sacral region, stage 4. Review of Patient #4’s “Home Health Plan of Care and Certification” revealed in part, “Order: Skilled Nursing frequency and duration: 3 times a week. Order: Observation and Assessment of Wound Healing Status, Measure Wound(s) Weekly.” Review of Patient #4’s medical record revealed a wound assessment, including wound measurements, was completed on 5/2/2024. The next wound assessment, including measurements was completed on 6/1/2024. There was no documentation of a wound assessment having been completed for 4 weeks.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview and record review, agency staff failed to maintain an accurate medication list on the plan of care as compared to what the patient is taking for 1 of 3 patients (Patient # 3) visits observed for a total of 7 patient records reviewed. Findings include: Review of agency policy titled “Plan of Care” dated 02/2024 revealed in part “4. The individualized plan of care must include the following: All Medications and Treatments” and under “21. Drugs and services and treatments administered by staff as ordered by physician/practitioner.” Record review of patient #3’s “Home Health Plan of Care and Certification” with start of care 12/16/2021 and certification period 06/03/2024 to 08/01/2024 revealed Patient #3’s primary diagnosis of Essential Hypertension. Record review of patient #3’s Plan of Care orders with certification period 06/03/2024- 08/01/2024 revealed in part “Medications: Aspirin Oral Tablet Delayed Release 81 mg (milligram) -1 tablet per day – po (by mouth).” During home visit observation on 06/04/2024 at 12:10pm, RN (Registered Nurse) C was observed completing medication set up for patient #3. RN C removed 2 pills from medication bottle labeled “Aspirin” and verbalized “Aspirin 81 mg 2 times per day.” During an interview with RN C at 12:10pm, when asked what patient # 3 physician orders for Aspirin states, RN C replied, “Bottle states take two times per day.””

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on record review, observation, and interview, the agency failed to develop POC (Plans of Care) individualized to meet the patient specific needs in 2 of 3 home visits observed (Patient #2 and #3) in a total of 7 patient records reviewed. Findings include: Review of agency policy titled “Plan of Care-CMS 485 and Physician/Practitioners Orders” revealed “Procedure: 2. Each patient must receive an individualized written POC including any revisions or additions. The individualized POC must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment. 4. The individualized POC must include the following: Patient-specific interventions and education, measurable outcomes, and goals.” Record review of Patient #2’s “Home Health Plan of Care and Certification” with start of care 11/13/2020 and certification period 04/26/2024 to 06/24/2024 revealed Patient #2’s primary diagnosis Type 2 Diabetes Mellitus with Hyperglycemia. POC orders revealed “Skilled nursing 3 times a day for 9 weeks. Skilled nursing to assess and evaluate for disease process management-diabetic management and medication management.” Patient #2’s POC did not contain patient specific interventions and orders for diabetic parameters in which to contact the physician regarding high or low blood sugar readings to meet the needs of Patient #2. During an observation of a home visit with LPN (Licensed Practical Nurse) B for Patient #2 on 06/04/2024 from 8:15 AM to 8:39 AM, LPN B obtained a blood sample with a lancet (a sharp cutting-type instrument used to puncture skin for drainage or blood sampling or small incisions) and placed blood drop on Patient #2’s glucometer (device for blood sugar readings) with the result of the blood glucose 200. During an interview with LPN B on 06/04/2024 at 8:40 AM, when asked how LPN B knows what to report if a blood sugar would be too high or too low and if any orders for reporting were obtained, LPN B replied, “I would call if 300, but 200 is within range. I think we have orders or they just haven’t been updated.” Record review of Patient #3’s “Home Health Plan of Care and Certification” with start of care 12/16/2021 and certification period 04/04/2024 to 06/02/2024 revealed Patient #2’s primary diagnosis Essential Primary Hypertension and secondary diagnosis Type 2 Diabetes Mellitus without complications. POC orders revealed “Skilled nursing 1 time a week for 9 weeks. Skilled nursing to assess and evaluate: Medication compliance and response.” Patient #3’s POC did not contain patient specific interventions and orders for blood pressure or diabetic parameters in which to contact the physician regarding high or low blood pressure or blood sugar readings to meet the needs of Patient #3. During an observation of a home visit with RN (Registered Nurse) C for Patient #3 on 06/04/2024 from 11:30 AM to 12:20 PM, RN C obtained a blood sample with a lancet and placed blood drop on Patient #3’s glucometer with the result of the blood glucose 172. RN C assessed Patient #3’s blood pressure which resulted 112/72. During an interview with RN C on 06/04/2024 at 12:20 PM, when asked how RN C knows what to report if a blood sugar would be too high or too low or blood pressures, RN C replied, “If too high or too low, I would use my own nursing judgement since I am here once a week. The order would be under medication management.” During an interview with Administrator H on 06/04/2024 at 9:30 AM, when asked what agency expectations are for obtaining orders for the POC for reporting parameters for diabetic needs of the patient, Administrator H replied, “If they have sliding scale insulin, there are parameters. If not, parameters should be on the POC.” When reviewing records for Patient #2 and #3’s POCs regarding missing diabetic reporting parameters, Administrator A confirmed and stated, “I don’t see them on here.””

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on record review and interview agency staff failed to include progress/clinical notes for 1 of 7 (#7) patient records reviewed. Findings include: Review of Patient #7’s medical record revealed Patient #7 was admitted to service on 2/2/2024 with a primary diagnosis of non-pressure ulcer of left calf with a secondary diagnosis of bacteremia. Review of Patient #7’s medical record revealed that Patient #7 had skilled nurse visits on 2/4/2024, 2/5/2024 and 2/7/2024. No other documented visits were found. Patient #7 was discharged from the agency on 03/28/2024. During an interview with Administrator H on 6/3/2024 at 12:30 PM Administrator H stated that the family notified agency staff on a visit that Patient #7 was admitted to the hospital on 2/8/2024. On 6/4/2024 it was discovered that a note was entered into Patient #7’s medical record on 6/3/2024 as to why and when Patient #7 was admitted to the hospital. Administrator H stated that the agency was contacted by hospital staff and told that Patient #7 would not be needing home health services upon discharge from hospital. No documentation of this conversation was found in Patient #7’s medical record.”

“Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This Element is not met as evidenced by: Based on record review and interview, the agency RN (Registered Nurse) failed to supervise the care provided by the LPN (Licensed Practical Nurse) in 1 of 7 patient (Patient #2) records reviewed. Findings include: Review of agency policy titled “Nursing Services” revealed “Procedure: 2. Professional nursing service will be provided by a RN and include: Supervising LPN and paraprofessionals providing services. 4. The LPN will be supervised by the RN as required by applicable state rules and regulations. Record review of Patient #2’s “Home Health Plan of Care and Certification” with start of care 11/13/2020 and certification period 04/26/2024 to 06/24/2024 revealed “Orders: Skilled nursing Frequency and Duration 3 times a day for 9 weeks.” Record review of Patient #2’s skilled nurse visits from 04/26/2024-06/03/2024 revealed an LPN conducted a visit 1-3 times daily all dates of this certification period. There was no documented evidence of LPN supervision completed by the RN from 04/26/2024 to 06/03/2024. The last RN supervision of the LPN was documented on 09/03/2022. During an interview on 06/04/2024 at 1:20 PM, findings were confirmed and reviewed with Administrator H and President I. When asked what the agency expectations are for nursing supervision of LPNs, Administrator H replied, “Every 60 days on a recert or 30 days if needed. The nurse is aware of this and should be doing this.””