Every finding on record at Maxim Healthcare Services

A recertification survey was conducted from 2/17/25 through 2/19/25. Maxim Healthcare Services was not in compliance with 42 CFR Part 484 requirements for home health agencies.

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 record review and interview the agency failed to electronically submit their completed Outcome and Assessment Information Set (OASIS) assessment to the Centers for Medicare and Medicaid (CMS) system within 30 days of completing the assessment of the beneficiary. Review of CMS’ Home Health Agency Error Summary report dated 1/1/24 to 12/31/24 revealed a Warning message, 3330, which indicated 13.3% of the OASIS assessments submitted were submitted late to the CMS system, meaning more than 30 days after the dates the comprehensive assessments were completed. On 2/19/25 at 9:15 AM, reviewed with the Director of Nursing (DON) the 1/1/24 to 12/31/24 Error Summary report. She said that she could not explain what might have occurred to cause the late OASIS submissions. She said she usually is the person responsible for transmitting the OASIS assessments, although she was on leave for several months in 2024. She also said that after submitting the OASIS assessments she did not view the entire report response after her submission; so, it was possible she had not seen when the system had alerted her to a submission being late.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on record review and interview the agency failed to ensure care plans included coordinated care related services from the infusion provider for 1 of 8 sampled residents (#4). Review of patient #4’s plan of care dated 1/10/25 to 3/10/25, note the patient’s Broviac central line dressing and cap was to be changed every 7 days and as needed for soiling and or patency. There was also an order to perform a heparin lock flush with 4 milliliters of heparin intravenous solution, 10units per milliliter (u/ml), every day for the Broviac central line. On 2/19/2025 at 10:02 AM, Clinical Supervisor#1 said another company, an infusion company, has been performing patient #4’s Broviac central line dressing change and obtaining ordered blood labs. Clinical Supervisor #1 verified that this company’s involvement in patient #4’s care was not in the plan of care, as having those responsibilities. On 2/19/2025 at 10:43 AM, the pharmacist of the infusion company was contacted by telephone and the DON was present. He verified the infusion company had been changing patient #4’s Broviac central line dressing since 2023. He added the dressing was changed weekly. The pharmacist admitted that he could not see Home Health Agency’s medical record but was aware the agency was providing services to patient #4. He said yesterday he received orders from the gastroenterologist to decrease the heparin flush from 4 ml to 3 ml per day, which was not reflected in patient #4’s plan of care. On 2/19/2025 at 10:56 AM the DON acknowledged that the agency should have included the services provided by the infusion company in the patient’s plan of care to accurately disseminate which services were being provided by each provider. The DON said she received the new flush order for 3 ml of heparin on 1/29/25. She also verified that it was important to have coordinated with the infusion company so that the most up-to-date physician’s order was reflected in patient #4’s plan of care.

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 and interview the agency failed to ensure that documentation regarding tube feeding was accurately documented according to agency policy for 1 of 8 sampled patients (#4). Review of patient #4’s medical record revealed a start of care date of 3/22/2023. Some of her diagnoses included: Turner’s Syndrome, gastrostomy status, short bowel syndrome, and encephalopathy. Review of patient #4’s plan of care dated 1/10/25 to 3/10/25 revealed tube feeding orders to mix water with 4 scoops of formula Elecare Jr. and 3 scoops of Duocal for an amount of 210 milliliters and provide at a rate of 70 milliliters per hour (ml/hr) 6 times daily, every 4 hours. Review of Registered Nurse (RN) A’s skilled nursing note dated 2/17/2025 timed 5:37 AM to 2:17 PM revealed in the intake section of the note that 210ml of tube feed intake occurred at 7:00 AM and 11:00 AM. There was no hourly documentation done regarding tube feeding intake. On 2/18/25 at 4:23 PM, the DON reviewed RN A’s skilled nursing note regarding the documentation of tube feeding and verified that it was not clear how the feeding had been administered and that she should have documented each hour feeding was running to indicate how much was administered. Review of Licensed Practical Nurse (LPN) A’s skilled nursing note dated 2/1/2025 timed 5:30 AM to 4:59 PM revealed in the intake section of the note that at 7:35 AM tube feed intake was 70 ml. It was also documented in the nursing narrative documentation that a tube feeding was occurring at 6:00 AM. Another tube feeding was running at 9:03 AM. There was no hourly documentation done regarding tube feeding intake. On 2/19/2025 at 2:15PM, the DON reviewed LPN A’s skilled nursing note dated 2/1/2025 regarding the documentation of tube feeding and verified that it was not clear how the feeding had been administered and that she should have documented each hour feeding was running to indicate how much was administered. Review of LPN B’s skilled nursing note dated 1/27/25 timed 5:31 AM to 3:31 PM revealed in the intake section 7:00 AM and 11:17 AM 210ml of tube feeding intake occurred. There was no hourly documentation done regarding tube feeding intake. On 2/19/2025 at 2:45PM, the DON reviewed LPN B’s skilled nursing note dated 1/27/2025 regarding the documentation of tube feeding and verified that it was not clear how the feeding had been administered and that she should have documented each hour feeding was running to indicate how much was administered. Review of the job aid document regarding the nursing flow sheet with effective and revised dates of 9/18/17 in the intake/output/other section it was noted that nursing should document all of the intakes at the time they occur, or at each hour.

Complaint investigation #2023015885 was conducted from 10/24/23 through 10/26/26. Maxim Healthcare Services was not in compliance with 42 CFR 484 .102 Subpart A-C, requirements for Home Health Agencies.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on record review, the agency failed to coordinate care delivery with emergency medical providers by performing a timely removal of a ventilator from a support stand in one of seven sampled patients. (#1) Findings: A review of the medical record of patient #1 was performed. The Plan of Care (start of care date of 12/20/22) which covered the more recent Certification Period of 8/17/23 to 10/15/23, signed by the physician on 8/22/23 read: “Principal diagnosis: other specified congenital musculoskeletal deformities. . . . Other pertinent diagnoses: “Bronchopulmonary dysplasia originating in the perinatal period. Dependence on respirator (ventilator) status. Encounter for attention to gastrostomy. Encounter for attention to tracheostomy. . . .Frequency and duration Maxim Healthcare Services to provide skilled nursing services for 12-24 hours per day, 5-7 days per week, for 60 days. . . . “ Therefore, the patient required the use of a ventilator and was seen at least five days a week for a minimum of twelve hours a day. A nurse Narrative Documentation entry at 6:45 AM by A-LPN (Licensed Practical Nurse) read: “Asked grand parent if he normally gets this cold he notified grandmother who then stated he has to go to hospital she then called 911.” Further documentation review revealed an eventual arrival by EMS (Emergency Medical Services). A review of documentation from Orange County Fire Rescue was performed. It indicated an arrival time on 9/13/23 at 7:10 AM. It read: "R42 arrived on scene to a residential home where E42 was on scene assessing the PT (patient). PT was not alert, unconscious, and not breathing. PT had a tracheostomy tube and was hooked up to a ventilator. . . . Someone who identified themselves as a nurse on scene stated that he had been with the PT all night and that he had turned cold '30 or 45 minutes' prior to EMS arrival. Chest compressions were initiated while the nurse on staff attempted to disconnect the ventilator and have it transported with the PT. Initial rhythm was asystole. Ventilator was on a mobile stand. Staff and family on scene appeared to be unknowledgeable of how the ventilator was to be disconnected or how it worked entirely. Staff was unknowledgeable of how PT should be ventilated if ventilator failed. Once ventilator was off the stand, PT was placed on the stretcher. Ventilator was taken during transport.” Therefore, the inability to promptly disconnect the ventilator from its stand exhibited a failure to properly coordinate with other medical providers.

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 interview record review and a review of agency documentation, the agency failed to ensure that all entries concerning continuous tube feeding and ventilator respirator rate were complete or clear and accurate, in accordance with policy, in one of seven sampled patients. (#1) A review of the medical record of patient #1 was performed. The Plan of Care (start of care date of 12/20/22) which covered the more recent Certification Period of 8/17/23 to 10/15/23, signed by the physician on 8/22/23 read: “Principal diagnosis: other specified congenital musculoskeletal deformities. . . . Other pertinent diagnoses: “Bronchopulmonary dysplasia originating in the perinatal period. Dependence on respirator (ventilator) status. Encounter for attention to gastrostomy. Encounter for attention to tracheostomy. . . .Frequency and duration Maxim Healthcare Services to provide skilled nursing services for 12-24 hours per day, 5-7 days per week, for 60 days. . . . Code status: Full. . . . Vital signs: Skilled nurse to obtain vital signs to include temperature, respirations, pulse, and pulse ox each shift and as needed for changes in patient condition. . . . Trilogy Ventilator: . . . Breath Rate: 30. Hours/days on ventilator: 24/7. . . . Enteral feedings: Enteral Formula: Similac Advance 24 kcal/ounce. . . . Feeding regimen: nighttime (from 9:00 PM – 6:20 AM). Add 400 ML of formula into the feeding bag. Set feeding dose to 390 ML. Set feeding rate to 42 ML/hour and run continuous.” The document Skilled Nursing Note of 9/12/23 (into 9/13/23) by A-LPN indicated that the shift began on 9/12/23 at 7:36 PM. Under the Skilled Nursing Note section Intake/Output, the nurse made an entry at 7:37 AM which read: “Up @ 9:00 PM – down @ 6:00 AM.” This was under the column “Intake Type.” Therefore, a continuous tube feeding was running from 9:00 PM through 6:00 AM. This was the only entry made during the shift regarding the tube feeding. The medical record of patient #1 had Nursing Narrative Documentation at 4:00 AM by A-LPN which read: “VSS no issues.” This was the last documented entry by this nurse until 6:30 AM. Nursing Narrative Documentation of 6:30 AM by A-LPN read: “Noticed that pt was feeling cold used blanket.” Therefore, two and a half hours had passed without any entries in the medical record. Further review of the medical record of shifts where A-LPN had care of the patient was performed. On 9/10/23,9/9/23, 9/8/23 and 9/7/23 the nurse did not document tube feeding intake at least once an hour. A review of facility policy Nursing Flow Sheet revealed the following: “Intake/Output/Other. . . . If continuous feeds are provided, fill in each hour. . . . Document the intake in units of OX, ML, etc. . . . Document all of the intakes at the time they occur, or at each hour. . . . Nurses should attempt to document every 2 hours, unless otherwise directed by state or payer requirement.” Record review revealed that the nurse was not in compliance with this expectation. Thus, facility policy required that the status of tube feedings to be documented at least every two hours, at a minimum. A-LPN did not comply with this policy expectation. Under the Ventilator section, an entry at 7:05 PM on 9/12/23 by A-LPN read: “Resp Rate (BPM) 19.” This rate contradicted physician orders for a breath rate of 30. There was no corresponding documentation explaining the discrepancy. Under the Respiration section of the Skilled Nursing Note, the last three recorded entries were as follows for “respiration rate”: “12:00 AM 18; 6:29 AM 121; 6:30 AM 18.” Regarding this, the Plan of Care had ordered a breath rate of 30 on the ventilator. Therefore, the nurse documented that he was not following the correct breath rate with the ventilator machine at all of these times. A further review of the medical record of shifts where A-LPN had care of the patient was performed. On 9/10/23, in the Respiration section, the nurse documented a respiration rate of 18, which did not correspond to the Plan of Care. Also, in the Ventilator section, the nurse documented a “Resp Rate” of 19, which did not correspond to the plan of care. On 9/9/23, in the Respiration section, the nurse documented a respiration rate of 18, which did not correspond to the Plan of Care. Also, in the Ventilator section, the nurse documented a “Resp Rate” of 20, which did not correspond to the plan of care. On 9/8/23, in the Respiration section, the nurse documented a respiration rate of 18, which did not correspond to the Plan of Care. Also, in the Ventilator section, the nurse documented a “Resp Rate” of 19, which did not correspond to the plan of care. On 9/7/23, in the Respiration section, the nurse documented a respiration rate of 18, which did not correspond to the Plan of Care. Also, in the Ventilator section, the nurse documented a “Resp Rate” of 19, which did not correspond to the plan of care. A review of facility policy Patient/Client Record: Content and Requirements revealed the following: “A patient/client record will be maintained for each patient/client receiving care. The patient/client record will contain sufficient information to: . . . Accurately document care provided and outcome(s). . . . The contents of the patient/clinical record may include (as applicable), but is not limited to the following: . . . Ongoing assessments (if applicable) . . . Signed and dated clinical notes. . . . The patient/client record shall be organized in a standardized format with tabs as follows unless maintained in the system of record: . . . Nurses notes . . . Ventilator flow sheets.” It was evident from record review that various entries concerning the respiratory rate were either not accurate or they testified to a non-compliance with orders. If the latter, they were not accompanied by sufficient information to explain or justify the discrepancy. During an interview with the clinical Manager on 10/26/23 at approximately 2:30 PM, she confirmed the preceding.

Complaint Investigation #2022006181 was conducted on 6/6/22. Allegations were substantiated and Maxim Healthcare Services remains in non- compliance with 42 CFR 484 Subpart A-C, requirements for Home Health Agencies.

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 interview, record review and a review of agency documentation, the agency failed to ensure that services ordered by the physician involving the completion of assigned shifts and the administration of scheduled medications were followed in one of three sampled patients. (#1) A review of the medical record of patient #1 was performed. Th CMS-485 of 3/17/22 for the Certification Period of 3/16/22 - 5/14/22 read: "Skilled nursing: Frequency and Duration Maxim Healthcare Services to provide Skilled nursing services for 16-24 hours per day 4-7 days per week, for 60 days." The CMS-485 continues: "Pt (patient) will take medications as ordered without clinically significant medication issues throughout this certification period." The CMS-485 listed patient medications as follows: Acetaminophen (as needed); Clonidine; Desmopressin; diazepam; diphenhydramine (as needed), and esomeprazole magnesium; Fluticasone propionate; gabapentin; hydrocortisone; Keppra; Miralax (as needed); Poly-Vi-Sol; propranolol; senna (scheduled in the patient's Medication Administration Record, or MAR, as in the evening); simethicone (as needed); and Synthroid. The CMS-485 also read: "Contingency plans for back-up nursing coverage. Patient's Family / Guardian is able to provide care in the absence of nursing coverage." Also: "Medication administration: Medication to be administered by Maxim during Maxim shifts and medications to be administered by PCG (Patient Care Giver) when Maxim not present. Administer per physician order." A "Nursing Flow Sheet" of 4/16/22, which indicated nurse arrival at 7:00 PM, by #A-LPN (Licensed Practical Nurse) read: "7:00 PM - nurse arrived @ pt home. 7:50 PM - pt arrived @ home, nurse administered all 7:00 PM scheduled . . . . " The nurse had other entries at 8:11 PM, 8:40 PM, 11:00 PM and 1:08 AM (on 4/17/22). An entry at 1:44 AM on 4/17/22 read: "All scheduled 2:00 meds given." AN entry by #A-LPN at 2:32 AM on 4/17/22 read: "Pt is currently in bed sleeping. Pt was left in the care of grandparents @ home." As to whether or not the patient's grandparents had been cleared as being capable of caring for the patient in the absence of a nurse, there was no evidence in the medical record to support this. Thus, the LPN left the house at approximately 2:32 AM and left the patient in the care of unqualified individuals. There was no mention of the patient's mother (the PCG) or Maxim Healthcare Services having been notified by the LPN of her early departure. During an interview of the Clinical Manager on 6/6/22 at 1:38 PM, she stated that the LPN was originally scheduled to work through 7:00 AM on 4/17/22. A review of the Medication Administration Record for 4/17/22 revealed that the following medications were not administered at their designated times in the shift of #A-LPN: fluticasone propionate (6:00 AM); Poly-Vi-Sol (6:00 AM); Synthroid (6:00 AM); esomeprazole magnesium (6:00 AM); gabapentin (6:30 AM); Keppra (6:30 AM); Desmopressin (6:00 AM); Diazepam (6:30 AM); Clonidine HCL (6:30 AM); hydrocortisone (bulk) powder (6:30 AM); and propranolol (6:30 AM(). A review of the document "Investigation Case" of 4/26/22 by the Recruitment Operation Manager revealed the following: "Nurse (#A-LPN) confirmed with me on Friday 4/15 that she would be attending her shifts on Saturday 4/16 and Sunday 4/17. She went to her shift on Saturday, clocked in around 7 PM, and checked out around 2:30 AM without notifying anyone in the home, no one assumed care of the patient. PCG woke up at 7 AM to sign out (#A -LPN) and she was not there. 7 AM medications were not given until PCG administered them . . . . Patient was unattended from 2:30 AM - 7 AM." When the LPN left her shift early in the morning, she violated the CMS-485 orders that Maxim staff assume responsibility with medications while on duty. This duty period was violated. During an interview of the Clinical Manager on 6/6/22 at approximately 5:00 PM, she confirmed the preceding.

Complaint Investigation #2022005261 was conducted on 4/21/22 and 4/28/22. Maxim Healthcare Services was not in compliance with 42 CFR 484 Subpart A-C, requirements for Home Health Agencies.

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 interview, record review and manufacturer documentation, the agency failed to ensure that physician ordered services in the form of Gastrostomy Tube use was in accordance with manufacturer’s instructions in one of three sampled patients. (#1). Findings: A review of facility policy “Pediatrics – Digestive System: Gastrostomy Tube Feeding” revealed the following: “Do not exceed balloon capacity. Never fill the balloon with more than 10 ML (or prescribed amount) of fluid.” A review of the medical record of patient #1 was performed. The patient began services with the agency on 11/3/20. The patient had a G-Tube which was last been changed on 2/23/22. The CMS 485 form for the Certification Period of 2/26/22 to 4/26/22 (signed by the physician on 3/4/22) read: “Enteral Tube Type / Size Type: Mic-Key Button. Size: 16 French. Maintain balloon with 5-6 ML (milliliters) of distilled or sterile water. G-tube to be changed every 2-3 months and as needed …. “ Thus, the physician prescribed the G-Tube balloon to be filled in the range of 5 to 6 ML. Regarding any manufacturer’s instructions which might address the maintenance of the balloon, a review of manufacturer documentation revealed the following: “Check the volume of water in the balloon at least once a week.” There was no evidence in the medical record of such weekly checks having been performed. During an interview of the Clinical Manager on 4/28/22 at 10:30 AM, she confirmed the preceding. During an interview of the Clinical Operations Specialist on 4/28/22 at 10:45 AM, he stated that he has instructed staff (prior to the incident) to deflate and inflate to check the volume on each shift. However, the only documented requirement for checking fluid volume was found in the manufacturer’s instructions.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure that an incorrect delivery of care in the form of improper G-Tube (Gastrostomy Tube) balloon volume was reported for investigation and coordination by supervisory staff in one of three sampled patients. (#1) Findings: A review of facility policy “Pediatrics – Digestive System: Gastrostomy Tube Feeding” revealed the following: “Do not exceed balloon capacity. Never fill the balloon with more than 10 ML (or prescribed amount) of fluid.” A review of the medical record of patient #1 was performed. The patient began services with the agency on 11/3/20. The patient had a G-Tube which was last been changed on 2/23/22. The CMS 485 form for the Certification Period of 2/26/22 to 4/26/22 (signed by the physician on 3/4/22) read: “Enteral Tube Type / Size Type: Mic-Key Button. Size: 16 French. Maintain balloon with 5-6 ML (milliliters) of distilled or sterile water. G-tube to be changed every 2-3 months and as needed …. “ Thus, the physician prescribed the G-Tube balloon to be filled in the range of 5 to 6 ML. A nurse’s note by LPN #A of 3/31/22 at 7:00 PM read: “7:00 PM. Received a report from the day nurse. The client on his back. . . . G-tube was patented (as written). G-tube assessment with the client’s father, and some of the fluid was removed from the balloon.” Thus, LPN #A documented the need to remove excess fluid from the balloon. During an interview of LPN #A on 4/28/22 at 9:24 AM, she stated that when she arrived on 3/31/22, she found that the unopened box for the Mic-Key Gastrostomy Feeding tube (by Avanos) on the patient’s bed. She stated that the day nurse (LPN #B) was there. The patient’s father stated that the G-tube was not working and that he was about to change it. She told him that they should both look at it together. She stated that upon observation, she noticed that the outer component of the apparatus was too tight against the skin. She deduced that this was because there was too much fluid in it. She monitored the father removing the fluid. She stated that he removed 3 ML, at first. She told him that they need to remove all of the fluid so that they could actually see how much was in there. He withdrew the remaining fluid and was upset with discovering excess fluid. She stated that she did not immediately report this incident to supervisory staff. She stated that she eventually reported the discovery to the Clinical Operations Specialist. She could not recall a specific date, but she conceded that it could have been on 4/7/22 or 4/8/22. A communication note of 4/8/22 by the Clinical Operations Specialist read: “Nurse …. (#A) notified she found the patient’s G-tube balloon inflated with 15 ML. Nurse educated the PCG (Patient Care Giver) and other nurse …. (#B) on how to change the G-Tube and inflate balloon with 5 ML. After that nurse found the G-Tube over inflated again. Direct clinical supervisor is aware.” This entry indicates that overinflation was a repeat occurrence. During the interview of LPN #A on 4/28/22 at 9:24 AM, she stated that the report indicating the overinflation happening “again” was a reference to a prior discovery of overinflation on 2/23/22 during a G-tube change. She stated that she had not reported her discovery on 2/23/22 to supervisory staff. She stated that on 2/23/22 the day nurse witnessed her (LPN #A’s) discovery of overinflation. She told the day nurse that the bladder should only have 5 or 6 ML. Thus, LPN #A had not reported the 2/23/22 discovery and, although the 3/31/22 incident was reported to supervisory staff, it was not done in a timely manner. Regarding reported incidents, a review of facility policy “Incident Reports” revealed the following: “The office reports, tracks and documents all incidents whether or not the incident resulted in a realized untoward outcome for a patient / client or employee. . . . . Definitions: Incident: Any situation involving a patient / client or family member / caregiver which is not consistent with regular routine, regardless of whether or not there was an apparent injury or other damage.” During an interview of the Administrator on 4/21/22 at 2:05 PM, he confirmed that the report of an overfilled G-tube balloon merited an incident report. He also confirmed that LPN #A, should have reported to supervisory staff an inflated G-Tube balloon. During an interview of the Clinical Manager on 4/28/22 at approximately 12:43 PM, she stated that at least the 3/31/22 incident should have been reported, as it was evident that it was an ongoing issue. She stated that the eventual report of 4/8/22 should have been done as soon as possible upon the 3/31/22 discovery of the bladder being overfilled, again. During an interview of LPN #B on 4/21/22 at 1:05 PM, she stated that the balloon issue was discussed with her by LPN #A. A review of facility policy “Incident Reports” revealed the following: “When an incident occurs, an incident Report is submitted by a clinician.” During an interview of the Administrator on 4/21/22 at approximately 3:15 PM, he stated that “clinician” refers to supervisory staff, not the nurses in the field. He stated that the nurses in the field are expected to contact supervisory staff with their concerns. Thus, LPN #A witnessed an overfilled balloon on 2/23/22 and did not report it, in violation of policy. Also, LPN #A did not report the incident of 3/31/22 to supervisory staff in a timely manner.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This ELEMENT is not met as evidenced by: Based on interview and a review of agency documentation, the agency failed to ensure that the discovery of a failure in following the plan of care concerning maintenance of a G-Tube (Gastrostomy Tube) was investigated to determine the cause the failure for immediate correction and its potential to threaten the health and safety of the patient in one of three sampled patients. (#1) Findings: A review of facility policy “Pediatrics – Digestive System: Gastrostomy Tube Feeding” revealed the following: “Do not exceed balloon capacity. Never fill the balloon with more than 10 ML (or prescribed amount) of fluid.” A review of the medical record of patient #1 was performed. The patient began services with the agency on 11/3/20. The patient had a G-Tube which was last been changed on 2/23/22. The CMS 485 form for the Certification Period of 2/26/22 to 4/26/22 (signed by the physician on 3/4/22) read: “Enteral Tube Type / Size Type: Mic-Key Button. Size: 16 French. Maintain balloon with 5-6 ML (milliliters) of distilled or sterile water. G-tube to be changed every 2-3 months and as needed …. “ Thus, the physician prescribed the G-Tube balloon to be filled in the range of 5 to 6 ML. A nurse’s note by LPN #A of 3/31/22 at 7:00 PM read: “7:00 PM. Received a report from the day nurse. The client on his back. . . . G-tube was patented (as written). G-tube assessment with the client’s father, and some of the fluid was removed from the balloon.” Thus, LPN #A documented the need to remove excess fluid from the balloon. During an interview of LPN #A on 4/28/22 at 9:24 AM, she stated that when she arrived on 3/31/22, she found that the unopened box for the Mic-Key Gastrostomy Feeding tube (by Avanos) on the patient’s bed. She stated that the day nurse (LPN #B) was there. The patient’s father stated that the G-tube was not working and that he was about to change it. She told him that they should both look at it together. She stated that upon observation, she noticed that the outer component of the apparatus was too tight against the skin. She deduced that this was because there was too much fluid in it. She monitored the father removing the fluid. She stated that he removed 3 ML, at first. She told him that they need to remove all of the fluid so that they could actually see how much was in there. He withdrew the remaining fluid and was upset with discovering excess fluid. She stated that she eventually reported the discovery it to the Clinical Operations Specialist. She could not recall a specific date, but she conceded that it could have been on 4/7/22 or 4/8/22. A communication note of 4/8/22 by the Clinical Operations Specialist read: “Nurse …. (#A) notified she found the patient’s G-tube balloon inflated with 15 ML. Nurse educated the PCG (Patient Care Giver) and other nurse …. (#B) on how to change the G-Tube and inflate balloon with 5 ML. After that nurse found the G-Tube over inflated again. Direct clinical supervisor is aware.” An additional communication note of 4/8/22 by the Clinical Operations Specialist read: “Left voice mail as an attempt to educate nurse …. (LPN #B) on the G-tube management.” During the interview of LPN #A on 4/28/22 at 9:24 AM, she stated that the report indicating the overinflation happening “again” was a reference to a prior discovery of overinflation on 2/23/22 during a G-tube change. During the interview of the Clinical Operations Specialist on 4/21/22 at 12:15 PM, he confirmed that he had tried to contact LPN #B regarding the reported excess fluid in the G-Tube balloon but she never called back and that he was not aware of any further actions regarding the reported incident. Regarding reported incidents, a review of facility policy “Incident Reports” revealed the following: “The office reports, tracks and documents all incidents whether or not the incident resulted in a realized untoward outcome for a patient / client or employee. . . . . Definitions: Incident: Any situation involving a patient / client or family member / caregiver which is not consistent with regular routine, regardless of whether or not there was an apparent injury or other damage.” During an interview of the Administrator on 4/21/22 at 2:05 PM, he confirmed that a report of an overfilled G-tube balloon merited an incident report and further investigation. During an interview of LPN #B on 4/21/22 at 1:05 PM, she stated that the balloon issue was discussed with her, with LPN #A. Regarding the reported communication by the Clinical Operations Specialist, she (LPN #B) stated that she had not received a message and had no communication with supervisory staff regarding the issue of an overfilled G-Tube balloon. A review of facility policy “Incident Reports” revealed the following: “When an incident occurs, an incident Report is submitted by a clinician.” During an interview of the Administrator on 4/21/22 at approximately 3:15 PM, he stated that “clinician” refers to supervisory staff, not the nurses in the field. He stated that the nurses in the field are expected to contact supervisory staff with their concerns. The policy continued: “The office clinical leader, office operations leader or their designee may be asked to interview the employee who was involved in or observed the incident as part of the follow-up process.” Thus, policy presents the prospect of further exploring a reported incident. This was not followed with respect to the report of 4/8/22, as the intended discussion with LPN #B was not performed. Thus, the agency was aware of a situation concerning the patient’s G-Tube balloon being overfilled. The Clinical Operations Specialist was aware as of 4/8/22 that LPN #A had performed on-the-spot training of LPN #B. He indicated that the matter had to be further addressed with LPN #B. However, the Clinical Operations Specialist confirmed that he failed to pursue education of LPN #B beyond leaving a telephone message. Thus, an intended correctional measure for a reported incident was not implemented.