Mass General Brigham Home Care, Inc.

“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, policy review, and interview, the agency failed to ensure hand hygiene was performed prior to donning (putting on) gloves and infection control guidelines were maintained during a wound dressing change observation for 1 patient (#6), out of a total sample of 7 patient home visits. Findings include: Review of the agency policy entitled, Hand Hygiene and Fingernail Policy, effective 5/14/24, included the following: *Perform hand hygiene before donning gloves and immediately after doffing (removing) gloves whether sterile or non-sterile. Review of the agency policy entitled, Home Care Wound Dressing Application, revised 2/24/25, included the following: *Remove the old dressing ..... *Inspect the soiled dressing, and note the type and amount of drainage. *Discard the soiled dressing in the sealable waterproof trash bag. *Remove and discard your soiled gloves. *Perform hand hygiene. *Put on new gloves. Patient #6 was admitted to the agency in December 2025 with a diagnosis of Streptococcal Sepsis (a severe infection where the Streptococcus bacteria invade deep tissue). Review of the physician ordered Home Health Plan of Care for certification period 12/7/25 through 2/4/26 indicated the following: *Wound Care Instructions: Left Lateral Foot: -Irrigate open wound with Vashe (a topical wound cleanser). -Gently pack with Aquacel Ag (an antimicrobial wound dressing). -Paint incision with Betadine (a topical antiseptic that provides infection protection). -Cover with sterile gauze 4 inch by 4 inch (4 x4) followed by Abdominal Pad (ABD-a thick highly absorbent dressing). -Secure with Kerlix (bulky gauze bandage). -Change every other day and as needed for increased drainage. During a home visit observation of a wound dressing change on 12/17/25 at 11:00 A.M., Nurse #1 prepared her work area by setting up a clean field on a table and placing bandage scissors and an alcohol wipe packet on the field. She sanitized her hands and donned gloves. She removed the tape securing the Kerlix wrap on Patient #6 left foot. She then used the bandage scissors and cut into the Kerlix wrap to loosen it, removed the dressing and discarded it. She opened the alcohol wipe packet, cleansed the scissors and placed them on the clean field. Wearing the same gloves, she removed the Aquacel Ag dressing from the wound and discarded it. She then doffed her gloves, sanitized her hands and donned new gloves. After washing the wound with Vashe, she dried the wound with gauze, doffed her gloves and donned new gloves without sanitizing her hands and proceeded with the dressing change. During an interview on 12/17/25 at 12:00 P.M., Nurse #1 said she did not sanitize her hands after doffing and before donning new gloves, as required. She further said she did not doff, sanitize her hands and don new gloves prior to removing the Aquacel Ag dressing from the wound, as required.”

“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 record review, policy review, and interview, the agency failed to ensure clinical documentation was complete and appropriately authenticated and dated in accordance with currently accepted standards of practice for 12 patients (#3, #4, #6, #12, #13, #17, #7, #8, #10, #11, #15 and #16), out of a total sample of 17 patients. Findings include: 7. Patient #7 was admitted to the agency in September 2025 with a diagnosis of a laceration to the right lower extremity and required home care services. Review of the physician ordered Home Health POC, dated 9/18/25 through 11/16/ 25, indicated the following: -SN visit: 2 to 3 visits a week for 6 weeks, 10/5/25 to 11/15/25. Review of the clinical record indicated the following: *11/14/25 SN visit, note signed on 11/17/25. 8. Patient #8 was admitted to the agency in November 2025 with a diagnosis of bilateral primary osteoarthritis of the knees. Review of the physician ordered Home Health POC, dated 11/18/25 through 1/16/ 26, indicated the following: -PT visit: 2 visits every week for 2 weeks,11/18/25 to 11/29/25. -PT visit: 1 visit every week for 7 weeks, 11/30/25 to 1/16/25. Review of the clinical record indicated the following: *12/9/25 PT visit, note dated 12/9/25 and was not completed and signed by the clinician. 9. Patient #10 was admitted to the agency in December 2025 with a diagnosis of type 2 Diabetes Mellitus (chronic metabolic condition where the body either doesn’t produce enough insulin (hormone) or can’t use insulin effectively leading to high blood sugar levels) with hyperglycemia (high blood sugar levels) and required home care services. Review of the physician ordered Home Health POC, dated 12/2/25 through 1/30/ 26, indicated the following: -PT visit: 2 times a week for 9 weeks. -OT visit: 1 time a week for 9 weeks. Review of the clinical record indicated the following: *12/5/25 PT visit, note signed on 12/7/25. *12/12/25 OT visit, note signed on 12/15/25. 10. Patient #11 was admitted to the agency in October 2025 with a diagnosis of multiple myeloma (cancer of the blood). Review of a referral physician order, dated 11/28/25, indicated to resume home care services on 11/29/25, including skilled nursing, physical therapy and occupational therapy. Review of the clinical record indicated the following: *11/29/25 SN visit, note signed on12/1/25. Review of the physician ordered Home Health POC, dated 12/12/25 through 2/9/26, indicated the following: -SN visit: 2 times a week for 2 weeks, 12/12/25 through 12/20/25. Review of the clinical record indicated the following: *12/16/25 SN visit, note was unsigned by the clinician. 11. Patient #15 was admitted to the agency in October 2025 with a diagnosis of aftercare following surgery of a neoplasm (tumor) and required home care services. Review of the physician ordered Home Health POC, dated 10/3/25 through 11/6/25, indicated the following: -SN visit: 1 time a week for 1 week, then 2 times a week for 2 weeks, then 1 time a week for 7 weeks. Review of the clinical record indicated the following: *10/3/25 Admission SN visit, note signed on 10/6/25. *10/6/25 SN visit, note signed on 10/8/25, A discharge SNV note dated 11/6/25 was signed on 11/10/25. 12. Patient #16 was admitted to the agency in October 2025 with a diagnosis of surgical aftercare following surgery on the genitourinary system and required home care services. Review of the physician ordered Home Health POC, dated 10/16/25 through 12/14/25, indicated the following: -SN visit: 1 time a week for 9 weeks. Review of the clinical record indicated the following: *11/6/25 SN visit, note signed on 11/11/25. During an interview on 12/18/25 at 1:00 P.M., the Quality Compliance Specialist #1 said all the visit notes were not completed by the clinicians within 24 hours, as required. Review of the agency policy entitled, Entries into and Management of the Clinical Record, effective 9/1/24, included the following: *Entries into the clinical record will be initiated on the day care is provided to the patient, in the patient’s home. *All documentation should be completed by midnight of the same day, but within 24 hours at the latest for extenuating circumstances. 1. Patient #3 was admitted to the agency in September 2025 with a diagnosis of Pneumonia. Review of the physician ordered Home Health Plan of Care (POC) for certification period 11/15/25 through 1/13/26 indicated the following: -Skilled Nurse (SN) visit: 1-2 times a week for 10 weeks, 11/15/25 to 1/13/26. Review of the clinical record indicated the following: *12/11/25 SN visit, note signed on 12/13/25. 2. Patient #4 was admitted to the agency in August 2025 with a diagnosis of osteoporosis (bones are thin, weak and brittle) with right femur (thigh bone) fracture. Review of the physician ordered Home Health POC for certification period 10/3/25 through 12/1/25 indicated the following: -Occupational Therapy (OT) visit: 1 time every 2 weeks times 2 weeks, 10/17/25 to 10/25/25. Review of a signed physician Interim Order, dated 10/25/25, indicated 1-2 OT visits every 2 weeks for 2 weeks, 11/28/25-12/1/25. Review of the clinical record indicated the following: *10/24/25 OT visit, note signed on 10/26/25. *11/28/25 OT visit, note signed on 11/30/25. 3. Patient #6 was admitted to the agency in December 2025 with a diagnosis of Streptococcal Sepsis (a severe infection where the Streptococcus bacteria invade deep tissue). Review of the physician ordered Home Health POC for certification period 12/7/25 through 2/4/26 indicated the following: -SN visit: 4 visits every week for 3 weeks, 12/7/25 to 12/27/25. Review of the clinical record indicated the following: *12/11/25 SN visit, note signed on 12/14/25. 4. Patient #12 was admitted to the agency in November 2025 with a diagnosis of cystitis (inflammation of the bladder). Review of the physician ordered Home Health POC for certification period 11/5/25 through 1/3/26 indicated the following: -Medical Social Work (MSW) visit: 1 visit every week for 2 weeks, 11/5/25 to 11/15/25. Review of the clinical record indicated the following: *11/10/25 MSW visit, note signed on 11/12/25. 5. Patient #13 was admitted to the agency in June 2025 with a diagnosis of right rib fracture. Review of the physician ordered Home Health POC for certification period 6/3/25 through 8/1/25 indicated the following: -OT visit: 1 visit every 2 weeks for 2 weeks, 6/3/25 to 6/14/25. -SN visit: 1 to 2 visits every week for 2 weeks, 6/3/25 to 6/14/25. Review of the clinical record indicated the following: *6/11/25 OT visit, note signed on 6/14/25. *6/12/25 SN visit, note signed on 6/15/25. 6. Patient #17 was admitted to the agency in September 2025 with a diagnosis of Stage 4 Pressure Ulcer of the Sacrum (full thickness tissue loss with exposed muscle, tendon, or bone situated between the two hipbones of the pelvis). Review of the physician ordered POC for certification period 9/5/25 through 11/3/25 indicated the following: -SN visit: 1-2 times a week for 10 weeks, 9/5/25 to 11/3/25. -PT visit: 1 time a week for 9 weeks, 9/8/25 to 11/3/25. Review of the clinic record indicated the following: *9/5/25 SN visit, note signed on 9/7/25. *9/15/25 Licensed Practical Nurse (LPN) visit, note signed on 9/18/25. *9/8/25 PT visit, note signed on 9/11/25. *9/15/25 PT visit, note signed on 9/18/25. *9/22/25 PT visit, note signed on 9/25/25. *9/29/25 PT visit, note signed on 10/1/25.”

“Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This Element is not met as evidenced by: Based on record review, policy review, and interview, the agency failed to ensure the Notice of Medicare Non-Coverage (NOMNC-an official Centers for Medicare and Medicaid Services {CMS} form that informs beneficiaries when their Medicare-covered skilled services, home health or outpatient rehabilitation services are ending and explains the right to appeal the decision) was provided prior to discharge for 2 patients (#14 and #15), out of a total sample of 17 patients. Findings include: 2. Patient #15 was admitted to the agency in October 2025 with a diagnosis of aftercare following surgery for a neoplasm. Review of the clinical record indicated Patient #15 was discharged from the agency on 11/6/25. Further review of the record indicated the NOMNOC was issued on 11/6/25 at the time of discharge. The record did not indicate that the patient/caregiver was provided with this information 2 days prior to the anticipated discharge, either in writing or via a telephone call, as required. During an interview on 12/18/25 at 11:30 A.M., the Quality Compliance Specialist #1 said a NOMNOC should be provided 2 days prior to discharge. She said Patient #15’s NOMNOC was not provided timely as required. Review of the agency policy entitled, Transfer or Discharge of Home Care Services, effective 12/01/2025, indicated the following: *All Medicare and Medicare Advantage patients will be issued a Notice of Medicare Non-Coverage (NOMNC) form in preparation of agency discharge. *At least 2 days prior to planned discharge from services, the patient will receive this form with the anticipated discharge date listed. *In the event that it is not possible to personally deliver form, the patient or their representative will be called and informed of the impending discharge and made aware of the appeal process. This will be documented in the Agency clinical record, and the completed form will be mailed to the patient or their representative. 1. Patient #14 was admitted to the agency in August 2025 with a diagnosis of calculus of gallbladder (gallstones). Review of the clinical record indicated the patient was discharged from the agency on 10/15/25. The clinical record did not contain any documentation that a NOMNC form had been provided to the patient prior to discharge, as required. During an interview on 12/18/25 at 1:00 P.M., the Quality Compliance Specialist #1 said there was no documentation to indicate the NOMNC form had been provided to the patient prior to discharge, as required.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on record review, policy review, and interview, the agency failed to ensure the initial assessment visit was completed either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner ordered start of care date, for 1 patient (#8), out of a total sample of 17 patients. Findings include: Review of the agency’s policy entitled, Initial and Comprehensive Assessment, dated 11/1/24, indicated the following: *An initial assessment of the patient will be performed and documented in the patient’s clinical record by a registered nurse, physical therapist, or speech therapist on all patients referred. The initial assessment must be performed either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the start of care date ordered by the physician (or other authorized licensed independent practitioner), or at the patient/caregiver request with the approval of the physician or allowed practitioner. Patient #8 was admitted to the agency in November 2025 with a diagnosis of bilateral primary osteoarthritis of the knees and required home care services. Review of the clinical record indicated a referral was made to the agency on 11/14/25. Review of the clinical record indicated Patient #8’s start of care was 11/18/25 and an initial assessment visit was completed on that day. During an interview on 12/18/25, the Quality Compliance Specialist # 2 said the initial assessment visit was not completed timely, as required.”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on record review, policy review and interview, the agency failed to ensure that services were provided as ordered by the physician or allowed practitioner as indicated in the plan of care, for 5 patients (#1, #8, #11, #16, and #14), out of a total sample of 17 patients. Findings include: 5. Patient #14 was admitted to the agency in August 2025 with a diagnosis of calculus of the gallbladder (gallstones). Review of the physician ordered Home Health POC for certification period 8/20/25 through 10/18/25 indicated the following: -Home Health Aide (HHA) visit: 1 time a week for 9 weeks, 8/20/25-10/18/25. Review of the clinical record indicated no HHA visit was provided for the week of 9/7/25. During an interview on 12/18/25 at 11:20 A.M., the Quality Compliance Specialist #1 said there was no HHA visit provided the week of 9/7/25, as ordered. Review of the agency’s policy entitled Care Planning Process, dated 12/1/25, indicated the following: *The care planning decisions will be reflected in the specific services that will be provided and the associated actions planned and implemented to meet the individualized patient problems and goals. *The plan of care will be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. 1. Patient #1 was admitted in November 2025 with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD-progress lung condition causing air flow blockage) and required home care services. Review of the physician ordered Home Health Plan of Care (POC), dated 11/13/25 through 1/11/26, indicated the following: -Skilled Nurse (SN) visit : 2 times a week for 4 weeks, 11/13/25 to 12/4/25. -SN visit: 1 time a week for 7 weeks, 12/5/25 to 1/11/26. -SN visit: 3 as needed (PRN), 11/13/25 to 1/11/26. Review of the clinical record indicated 1 SN visit was provided, not 2 as ordered, for the weeks of 11/16/25 and 11/23/25. During an interview on 12/17/25 at 3:30 P.M., the Quality Compliance Specialist #1 said the POC was not followed for SN visits during the weeks of 11/16/25 and 11/23/25, and 2 SN visits should have been provided each week, as ordered. 2. Patient #8 was admitted to the agency in November 2025 with a diagnosis of bilateral primary osteoarthritis of knees. Review of the physician ordered Home Health POC, dated 11/18/25 through 1/16/26, indicated the following: -Physical Therapy (PT) visit : 2 visits every week for 2 weeks, 11/18/25 to 11/29/25. -PT visit: 1 time a week for 7 weeks, 11/30/25 to 1/16/25. Review of the clinical record indicated 2 PT visits were provided, not 1, as ordered, for the weeks of 11/30/25 and 12/7/25. During an interview on 12/18/25 at 10:10 A.M., the Quality Compliance Specialist #2 said the POC was not followed, as ordered, relative to PT visits for the 2 weeks noted above. She said only PT visit should have been provided as per the POC. 3. Patient #11 was admitted to the agency in October 2025 with a diagnosis of multiple myeloma (cancer of the plasma blood cells) and required home care services. Review of the physician ordered Home Health POC, dated 10/13/25 through 12/11/25, indicated the following: -PT visit: 2 times a week for 2 weeks, 12/1/25 to 12/11/25. Review of the clinical record indicated 1 PT visit was provided, not 2 as ordered during the week of 12/7/25. Further review of the record indicated the patient refused a visit on 12/8/25, and there was no documentation to indicate a second visit was attempted during the same week. During an interview on 12/18/25 at 10:50 A.M., the Quality Compliance Specialist #4 said the POC was not followed for the week of 12/7/25, and 2 PT visits were not provided, as ordered. 4. Patient #16 was admitted to the agency in October 2025 with a diagnosis of surgical aftercare following surgery on genitourinary system and required home care services. Review of the physician ordered Home Health POC, dated 10/16/25 through 12/14/25, indicated the following: -SN visit: 1 time a week for 9 weeks. Review of the clinical record indicated the patient canceled the scheduled visit on 10/22/25 and requested a visit for 10/24/25. Further review of the record indicated no visit was provided on 10/24/25, and the patient did not receive a 1-time SN visit during the week, as ordered. During an interview on 12/18/25 at 11:20 A.M., the Quality Compliance Specialist #1 said the POC was not followed, as ordered, for Patient #16, and there was no documentation as to why the SN visit was not provided on 10/24/25, as requested.”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on record review, policy review and interview, the agency failed to ensure staff communicated with the physician involved in the plan of care, related to the current plan of care, for 4 patients (#1, #11, #16, and #14), out of a total sample of 17 patients. Findings include: Review of the agency’s policy entitled Missed Visits, dated 4/1/25, indicated the following: *If a visit is missed for any reason, the staff member should attempt to reschedule it for the same week so that the physician/allowed practitioner ordered frequency is maintained and would not be considered a missed visit. *If a visit is missed and not able to be rescheduled the home care staff will notify the physician/allowed practitioner, manager and care manager of the missed visit and document it in the patient’s record. 1. Patient #1 was admitted in November 2025 with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD-a progressive lung condition causing air flow blockage) and required home care services. Review of the physician ordered Home Health Plan of Care (POC), dated 11/13/25 through 1/11/26, indicated the following: -Skilled Nurse visit (SNV): 2 times a week for 4 weeks, 11/13/25 to 12/4/25. -SN visit: 1 time a week for 7 weeks, 12/5/25 to 1/11/26. -SN visit: 3 as needed (PRN) 11/13/25 to 1/11/26. Review of the clinical record indicated 1 SN visit, not 2 as ordered, was provided for the weeks of 11/16/25 and 11/23/25, and there was no documentation as to why they were missed. During an interview on 12/17/25 at 3:30 P.M., the Quality Compliance Specialist #1 said staff did not document why the visits were not provided, as ordered, nor that the physician had been notified, as required. 2. Patient #11 was admitted to the agency in October 2025 with a diagnosis of multiple myeloma (cancer of the plasma blood cells) and required home care services. Review of the physician ordered Home Health POC, dated 10/13/25 through 12/11/25, indicated the following: -Physical Therapy (PT) visit: 2 times a week for 2 weeks, 12/1/25 to 12/11/25. Review of the clinical record indicated 1 PT visit was provided, not 2 as ordered, during the week of 12/7/25. Further review of the record indicated the patient refused a visit on 12/8/25, and there was no documentation to indicate a second visit was attempted during the same week. During an interview on 12/18/25 at 10:50 A.M., the Quality Compliance Specialist #4 said there was no staff documentation to indicate the physician was notified of the missed visit, as required. 3. Patient #16 was admitted to the agency in October 2025 with a diagnosis of surgical aftercare following surgery on genitourinary system and required home care services. Review of the physician ordered Home Health POC, dated 10/16/25 through 12/14/25, indicated the following: -SN visit: 1 time a week for 9 weeks. Review of the clinical record indicated the patient canceled the scheduled visit on 10/22/25 and requested a visit for 10/24/25. Further review of the record indicated no visit was provided on 10/24/25, and the patient did not receive a 1-time SN visit during the week, as ordered. During an interview on 12/18/25 at 11:20 A.M., the Quality Compliance Specialist #1 said there was no documentation by staff to indicate why the requested visit for 10/24/25 was not provided, nor that the physician was notified of the visit not being provided, as requested. 4. Patient #14 was admitted to the agency in August 2025 with a diagnosis of calculus of the gallbladder (gallstones). Review of the physician ordered Home Health POC for certification period 8/20/25 through 10/18/25 indicated the following: -Home Health Aide (HHA) visit: 1 time a week for 9 weeks, 8/20/25-10/18/25. Review of the clinical record indicated no HHA visit was provided for the week of 9/7/25. Further review of the clinical record contained no documentation that the physician had been notified that the POC was not followed due to the missed HHA visit. During an interview on 12/18/25 at 11:20 A.M., the Quality Compliance Officer #1 said the physician had not been notified that the POC was not followed due to the missed HHA visit, as required.”

“Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA’s policies and procedures. This Standard is not met as evidenced by: Based on records reviewed and interviews, for one of three sampled patients (Patient #1), the Agency failed to ensure nursing staff provided care and services consistent with acceptable standards of nursing practice when after Nurse #1 inserted a urinary catheter into Patient #1, he/she experienced complications, which included but was not limited to blood after insertion, no urine output and pain, and despite returning to Patient #1’s home at his/her family member’s request, Nurse #1 did not notify the Physician or the Agency of the problems which Patient #1 experienced. Later that same day, Patient #1 had to be transferred to the Hospital Emergency Department for evaluation and required treatment related to the traumatic urinary catheter placement. Findings include: The Agency’s Policy, titled Verification of Physician/Medical Provider Orders, dated 03/01/25, indicated accurate physician or allowed practitioner orders would be obtained in accordance with state and federal laws and regulations. The Agency’s Policy, titled Indwelling Urinary Catheter Care and Management, dated 11/18/24, indicated nursing would verify the practitioner’s order prior to insertion of the catheter. The Agency’s Policy, titled Indwelling Urinary Catheter Insertion, dated 11/18/24, indicated nursing would advance the urinary catheter and check for urine flow. Once the urine started to flow, the nurse would inflate the balloon, instilling the recommended amount of sterile water, and then gently pull on the catheter until the inflated balloon was snug against the bladder neck. The Policy indicated never to inflate the balloon until first establishing urine flow, which ensures that the catheter is in the bladder. Patient #1 was admitted to the Agency in March, 2025, diagnoses included diabetes, stroke with resulting hemiplegia and dysphagia, urine retention, overactive bladder, and benign prostatic hyperplasia (BPH, enlargement of the prostate). Review of Patient #1’s Skilled Nursing Note, dated 04/16/25, indicated his/her spouse requested a physician’s order for placement of an indwelling urinary catheter so he/she could comfortably attend a family wedding over the following weekend. The Note indicated Patient #1’s spouse was unable to reach his/her physician to obtain the order, and indicated that Nurse #1 also tried calling Patient #1’s physician, but he did not answer and his voicemail was full. The Note indicated there were no new orders on that date. Review of Patient #1’s Physician’s orders for April 2025, indicated he/she did not have an active order for the insertion of an indwelling urinary catheter. Review of Patient #1’s Skilled Nursing Note, dated 04/23/25, indicated that at 03:30 P.M., Nurse #1 inserted an indwelling urinary catheter into Patient #1. The Note indicated Nurse #1 was told by Patient #1’s spouse what size catheter to use, that no urine was draining from the indwelling urinary catheter, and Nurse #1 observed blood after the insertion. The Note indicated Nurse #1 left Patient #1’s home 15 to 20 minutes after the catheter insertion, and told Patient #1’s spouse to bring him/her to the Hospital Emergency Department if anything seemed wrong. The Note indicated that at 04:00 P.M., Patient #1’s spouse called Nurse #1 and requested that she return to the home because something was wrong, and when Nurse #1 arrived back at the home, Patient #1’s spouse had already removed the catheter. Review of Patient #1’s Admit to Home Hospital Inpatient Note, dated 04/28/25, indicated he/she was hospitalized from 04/23/25 to 04/25/25, returned to the Hospital from 04/25/25 to 04/28/25 and was diagnosed with bacteremia and sepsis within a few hours of the traumatic indwelling urinary catheter placement, required antibiotics and was admitted to the Hospital Intensive Care Unit (ICU). During a telephone interview on 06/24/25 at 12:54 P.M., Nurse #1 said she was Patient #1’s primary nurse, and upon admission to the Agency, he/she had a physician’s order for nursing to insert an indwelling urinary catheter. Nurse #1 said Patient #1’s spouse later declined the catheter insertion and instead was intermittently catheterizing him/her, so she discontinued the physician’s order for an indwelling urinary catheter insertion. Nurse #1 said Patient #1’s spouse requested that an indwelling urinary catheter be inserted by nursing for the weekend of 04/25/25 so he/she could attend a family wedding comfortably. Nurse #1 said she had tried the week prior to obtain a physician’s order to insert an indwelling urinary catheter, however, was unable to reach Patient #1’s physician. Nurse #1 said that on 04/23/24, without a physician’s order, she inserted a 14 French urinary catheter that was already on hand in his/her home into Patient #1, said the insertion was slightly difficult, as Patient #1 had a diagnosis of Benign Prostatic Hyperplasia. Nurse #1 said she observed that there was some blood upon insertion, and that no urine emptied into the drainage bag before she inflated the balloon. Nurse #1 said she waited for and confirmed that urine emptied into the collection bag before she left the home. Although Nurse #1 said during her interview that there was some urine flow into the collection bag, her Skilled Nurses Note, dated 04/23/25, indicated there was no urine flow into the collection bag. Nurse #1 said she did not notify Patient #1’s physician of the insertion of the catheter or her observation of blood upon insertion of the catheter, then left Patient #1’s home and was heading to her next patient appointment, when Patient #1’s spouse called her and said she needed to return, as there was something wrong with the urinary catheter. Nurse #1 said she returned to the home 30 minutes after she had first left, and said Patient #1’s spouse had already removed the catheter. Nurse #1 said she did not assess Patient #1 at that time, did not notify his/her physician, and said she then left Patient #1’s home for the second time. During an interview on 06/24/25 at 01:36 P.M., Quality Compliance Specialist #1 said Nurse #1 should have obtained a physician’s order before insertion of the indwelling urinary catheter, but did not, should not have inflated the catheter balloon without first ensuring there was urine flow into the catheter, and said Nurse #1 should have assessed Patient #1 upon return to his/her home and notified the physician of her assessment, but did not.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on records reviewed and interviews, for one of three sampled patients (Patient #1), the Agency failed to ensure they provided services only as ordered by the physician, when Nurse #1 inserted an indwelling urinary catheter (tube inserted through the urethra and remains secured by a balloon in the bladder to drain urine) into him/her without a physician’s order. Findings include: The Agency’s Policy, titled Verification of Physician/Medical Provider Orders, dated 03/01/25, indicated accurate physician or allowed practitioner orders would be obtained in accordance with state and federal laws and regulations. The Agency’s Policy, titled Indwelling Urinary Catheter Care and Management, dated 11/18/24, indicated nursing would verify the practitioner’s order prior to insertion of the catheter. Review of Patient #1’s Physician’s Order, dated 03/25/25, indicated nursing would insert an indwelling urinary catheter, size 14 or 12 French (refers to the diameter of the catheter tubing) on 03/26/25. Review of Patient #1’s Skilled Nursing Note, dated 03/26/25, indicated his/her spouse declined placement of the indwelling urinary catheter, and indicated Patient #1’s spouse would instead catheterize Patient #1 intermittently (insert the catheter, and remove it once the bladder had drained). Review of Patient #1’s Skilled Nursing Note, dated 04/16/25, indicated his/her spouse requested a physician’s order for placement of an indwelling urinary catheter so he/she could comfortably attend a family wedding over the following weekend. The Note indicated Patient #1’s spouse was unable to reach his/her physician to obtain the order, and indicated that Nurse #1 also tried calling Patient #1’s physician, but he did not answer and his voicemail was full. The Note indicated there were no new orders obtained on that date. Review of Patient #1’s Skilled Nursing Note, dated 04/23/25, indicated that at 03:30 P.M., Nurse #1 inserted a size 14 French indwelling urinary catheter into Patient #1. The Note indicated Nurse #1 was told by Patient #1’s spouse what size catheter to use. During a telephone interview on 06/24/25 at 12:54 P.M., Nurse #1 said she was Patient #1’s primary nurse, and upon admission to the Agency, he/she had a physician’s order for nursing to insert an indwelling urinary catheter. Nurse #1 said Patient #1’s spouse later declined the catheter insertion and instead was intermittently catheterizing him/her, so she discontinued the physician’s order for an indwelling urinary catheter insertion. Nurse #1 said Patient #1’s spouse requested that an indwelling urinary catheter be inserted by nursing for the weekend of 04/25/25 so he/she could attend a family wedding comfortably. Nurse #1 said she had tried the week prior to obtain a physician’s order to insert an indwelling urinary catheter, however was unable to reach Patient #1’s physician. Nurse #1 said that on 04/23/24, without a physician’s order, she inserted a 14 French urinary catheter that was already on hand in his/her home into Patient #1. During an interview on 06/24/25 at 01:36 P.M., Quality Compliance Specialist #1 said Nurse #1 should have obtained a physician’s order before insertion of the indwelling urinary catheter, but did not.”