Direct Home Healthcare, Inc.

“Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: Based on a review of the Agency’s Emergency Preparedness Plan and staff interviews, it was determined the Agency failed to establish policies and procedures based on the risk assessment. This has the potential to affect all Pts. that receive service from the Agency. Findings include: 1. The Emergency Preparedness Plan last updated on 01/19/24 was reviewed on 01/07/25. The Plan included the “Hazard Vulnerability Analysis 2024” (risk assessment) form that contained different types of potential emergencies associated with weather, utility failures, hazardous materials, security, terrorism, community mass casualty and other emergencies. As of 01/07/25, the Emergency Preparedness Plan lacked policies and procedures based on the “Hazard Vulnerability Analysis 2024”. 2 During an interview with the Administrator, Agency Supervisor, OASIS Coordinator, Quality Assurance Nurse #1 and #2 on 01/07/25 at 2:49 PM, all confirmed the Emergency Preparedness Plan lacked policies and procedures based on the risk assessment.”

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on review of the Error Summary report and staff interviews, it was determined in 190 of 1081 assessments submitted for the last 12 months, the Agency failed to submit reports timely, resulting in a warning. Findings include: 1. The Error Summary report for 01/01/24 to 12/31/24, was reviewed on 01/07/25. The report included error # -3330 for 169 of 1081 (15.63 %) OASIS reports that were submitted more than 30 days, after the assessment was completed. 2. During an interview on 01/08/25 at 1:07 PM with the Agency Supervisor, OASIS Coordinator, Quality Assurance Nurse #1 and #2, the OASIS Coordinator confirmed that the error occurred.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on clinical record reviews and Staff interviews, it was determined that in 7 of 10 (Pts. 3, 10, 2, 5, 9, 4 and 6), clinical records reviewed, the patient care was not provided as ordered in the POC. 6. Pt. #4 was admitted to Home Health services on 12/14/24 with the primary diagnosis of Traumatic Subarachnoid Hemorrhage with Loss of Consciousness Status Unknown, Subsequent Encounter. The clinical record was reviewed on 01/07/25. The clinical record included the POC effective 12/14/24 that required OT “1wk1 Eval and treat”. The OT evaluation was conducted on 12/17/24 and included “Visit Frequency 1WK3”. As of 01/07/25, the record lacked documentation the OT provided service during the week of 12/22/24 to 12/28/24. 7. Pt. #6 was admitted to Home Health services on 12/20/24 with the primary diagnosis of Other Sequelae of Cerebral Infarction. The clinical record was reviewed on 01/07/25. The clinical record included the Physician Order dated 12/23/24 that required the OT to evaluate the Pt. The OT evaluation was conducted on 12/21/24 and included “Visit Frequency 1WK3”. As of 01/07/25, the record lacked documentation the OT provided service during the week of 12/22/24 to 12/28/24. 8. During an interview on 01/08/25 at 8:45 AM, and 1:07 PM to 3:00 PM, all confirmed the staff failed to provide service as indicated in the POC or ordered by the Physician. Findings include: 1. Pt. #3 was admitted to home health services on 08/26/24 with the diagnosis of Anemia, unspecified. The clinical record was reviewed on 01/08/25. The clinical record contained a POC effective 12/24/24, that required a PT evaluation and treatment. As of 01/08/25, there was no PT evaluation done as ordered in the POC. 2. Pt. #10 was admitted to home health services on 11/07/23 with the diagnoses of Type 2 Diabetes Mellitus with foot ulcer and Hypertensive Heart and Chronic Kidney disease with Heart failure and with stage 5 Chronic Kidney/ ESRD. The clinical record was reviewed on 1/8/25. The clinical record contained a POC effective 11/07/23, that required: “Orders for Discipline and Treatment Notify Physician of vital sign parameters out of range:….Systolic BP: Greater Than (>) 160…Diastolic BP: Greater Than (>) 100… Blood Sugar, Fasting….Blood Sugar, Random….Nursing…SN to obtain blood glucose level every SN visit….” The SOC assessment, completed by the SN on 11/07/23, indicated a BP reading of 183/93 mmHg. There was no Physician notified of Systolic or Diastolic BP falling outside of range, as ordered in the POC. The SOC assessment dated 11/07/23 and SN note dated 11/21/23, lacked a blood sugar assessment as ordered in the POC. The PT note dated 11/16/24, indicated a BP reading 169/98 mmHg and OT note dated 11/9/23, indicated a BP reading of 180/78 mmHg. The records lacked Physician notification of Systolic or Diastolic BP falling outside of range, as ordered in the POC. 3. Pt. #2 was admitted to the home health services on 07/01/24 with the diagnoses of: Mixed Hyperlipidemia; Heart Failure and Type 2 Diabetes Mellitus with Polyneuropathy. The clinical record was reviewed on 01/07/25. The clinical record contained a POC dated 12/28/24, that required the SN services 1 time a week for 9 weeks to notify the physician of heart rate below 60. The SN failed to notify the physician of the heart rate of 55 on 11/18/24 (weeks #4 and 6). 4. Pt. #5 was admitted to the home health services on 10/24/24 with the diagnoses of: Conduction disorder, unspecified and Encounter for attention to Gastrostomy. The clinical record was reviewed on 01/08/25. The clinical record contained a POC dated 10/24/24, that required the PT services 2 times a week for 6 weeks. The PT failed to visit/assess the patient weeks #2 and 3. 5. Pt. #9 was admitted to the home health services on 09/06/24 with the diagnosis of: Hemiplegia following Cerebral Infarction affecting Right Dominant side of care and Type 2 Diabetes Mellitus without complications. The clinical record was reviewed on 01/07/25. The clinical record contained a POC dated 09/06/24, that required the SN services 1 time a week for 9 weeks to notify the physician of heart rate below 60. The SN failed to notify the physician of the heart rate of 51 on 11/26/24 (week #4).”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on the clinical records reviewed and Staff interview, it was determined in 2 of 10 (Pts.#5 and 6) clinical records reviewed, the documentation was not complete. 2. Pt. #6 was admitted to Home Health services on 12/20/24 with the primary diagnosis of Other Sequelae of Cerebral Infarction. The clinical record was reviewed on 01/07/25. The clinical record included the “Admission Consent” form completed by the SN and dated 12/20/24. The Consent form contained the section titled, “Advance Directives” requiring the SN to place a check mark indicating whether the Pt. had an Advance Directive (Living Will, Power of Attorney for Health Care, Mental Health Treatment Preference Declaration, and Practitioner Order for Life-Sustaining Treatment). This section was left blank. 3. During interviews with the Agency Supervisor, OASIS Coordinator, Quality Assurance Nurse #1 and #2 on 01/08/25 at 8:45 AM and 1:07 PM, the Agency Supervisor confirmed staff failed to ensure documentation entered into the clinical record was complete. Findings include: 1. Pt. #5 was admitted to the home health services on 10/24/24 with the diagnoses of: Conduction disorder, unspecified and Encounter for attention to Gastrostomy. The clinical record was reviewed on 01/08/25. The clinical record contained a POC dated 10/24/24, that required the SN services 2 times a week for 2 weeks and 1 time a week for 8 weeks. The POC included “SN to teach the patient or caregiver to clean the site daily… Educate on signs of infection… Advise on when to seek medical attention. The clinical record included SN notes dated 10/24/24 and 10/26/24, that lacked documentation of the details of the G-tube instructions.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on the clinical records reviews, and Staff interview, it was determined in 3 of 10 (Pts. #2, 5 and 7) clinical records reviewed, the patient POC was not revised, based on the comprehensive assessments. 3. Pt. #7 was admitted to Home Health services on 11/21/24 with the primary diagnosis of Sepsis, Unspecified Organism. The clinical record was reviewed on 01/08/25. The clinical record included the referral for Home Health services dated 01/02/25, indicating the Pt. was discharged from a hospital, and contained “… has a history of stage IV sacral ulcer that is now scarred over… Wound 12/27/24 Pressure Injury Sacrum Left… Peri-wound fragile… Cleansed with wound cleanser foam… Triad cream, Aquacel Ag and foam”. The “OASIS-E1 Resumption of Care” assessment form was completed by the SN on 01/03/25 and contained “…Wound(s): Pressure injury (ulcer). Comments: redness to sacrum and open sore… Length: 1 cm… Width: 1 cm… Depth: 0.2 cm… Drainage: Serous. Drainage Amount: Minimal…Cleanse wound with normal saline and patted dry, applied medihoney to wound bed, cover with silicone foam dressing, change every other day or as needed if soiled or loose till healed…” The Resumption of Care Order and POC for Resumption of Care Following Hospital Stay, both completed by the SN on 01/03/25 lacked orders for wound care to the sacral ulcer. 4. During interviews with the Agency Supervisor, OASIS Coordinator, Quality Assurance Nurse #1 and #2 interviews on 01/08/25 at 8:45 AM and 1:07 PM, the Agency Supervisor confirmed the SN failed to update/revise the POC accordingly. Findings include: 1. Pt. #2 was admitted to the home health services on 07/01/24 with the diagnoses of: Mixed Hyperlipidemia; Heart Failure and Type 2 Diabetes Mellitus with Polyneuropathy. The clinical record was reviewed on 01/07/25. The clinical record contained a POC dated 12/28/24, that required the SN services 1 time a week for 9 weeks to weigh the patient every visit. The SN failed to revised the PsOC 12/28/24 for the bed bound patient, who was unable to stand for weights. 2.Pt. #5 was admitted to the home health services on 10/24/24 with the diagnoses of: Conduction disorder, unspecified and Encounter for attention to Gastrostomy. The clinical record was reviewed on 01/08/25. The clinical record contained a recertification POC dated 12/23/24, that was not revised and inappropriately included the Nursing goals for the G-tube that was removed/discontinued on 11/02/24.”

“Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This Element is not met as evidenced by: Based on a review of the Agency’s Pt. admission booklet, observation during home visits, clinical record reviews, and staff interviews, it was determined that in 10 of 10 (Pts. #1, 2, 3, 4, 5, 6, 7, 8, 9, and 10) clinical records reviewed, the Agency failed to provide the Pt./patient’s representative the Agency Supervisor’s name. Findings include: 1. The Agency’s Pt. admission folder was reviewed on 01/07/25. The folder lacked the name of the Agency Supervisor. 2. The following home visits were conducted on 01/07/25 and 01/08/25: Pt. #1. SOC 10/05/24. Pt. #2. SOC 07/01/24. Pt. #3. SOC 12/24/24. Pt. #4. SOC 12/14/24. During the home visits, the Pt. admission folders were observed, and lacked the name of the Agency Supervisor. During the home visits, the Pt/patient’s representative was not aware of the Agency’s Supervisor’s name. 3. The following clinical records were reviewed on 01/07/25 and 01/08/25: Pt. #1. SOC 10/05/24. Pt. #2. SOC 07/01/24. Pt. #3. SOC 12/24/24. Pt. #4. SOC 12/14/24. Pt. #5. SOC 10/24/24. Pt. #6. SOC 12/20/24. Pt. #7. SOC 11/21/24. Pt. #8. SOC 10/03/24. Pt. #9. SOC 09/06/24. Pt. #10. SOC 11/07/23. The clinical records lacked documentation that the Pt./patient’s representative was provided the name of the Agency Supervisor. 4. During an interview on 01/08/25 at 1:07 PM with the Agency Supervisor, OASIS Coordinator, Quality Assurance Nurse #1 and #2, all confirmed the Agency failed to provide the Pt./patient’s representative the Agency Supervisor’s name. .”